UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
February 10, 2016
________________
NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
Form 20-F [X] | Form 40-F [ ] |
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] | No [X] |
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-________
WHYDOSO MANYPEOPLE INCITIES GET DIABETES? GLP-1 Smallprotein, big potential OBESITY How do you market a treatment for a disease that many doctors don’t evenacknowledge? GLOBAL DEMAND for diabetes products triggers major productioninvestments
CONTENTS The Management review, as defined by the Danish Financial Statements Act (FSA), is found on pp 1–54 and 95. This Annual Report is published in English only. A shorter version, consisting of the Management review and excerpts from the consolidated statements, is available in Danish. In the event of any discrepancies, the English version shall prevail. 1 Letter from theChairman 2 Letter from theCEO 04 Novo Nordisk at aglance 06 2015 performance and 2016outlook 14 Performance highlights 16 Ourstrategy 18 Novo NordiskWay 20 Pipelineoverview 22 193 million people do not know they have diabetes –Are you one ofthem? 24 Future diabetes medicines –What’s next from Novo Nordisk’slabs? 26 GLP-1 –Small protein, bigpotential 28 Obesitycare –Building the market fromscratch 30 Tackling the rise of diabetes incities 32 30 years of changing haemophilia 33 The people behind itall 34 The future ofpharmaceuticals 38 Global demand triggers major production investments 40 Environmental strategy –Doing more withless 42 Managing risks 44 Shares and capitalstructure 46 Corporategovernance 49 Remuneration 52 Board ofDirectors 54 ExecutiveManagement 55 Consolidated financial, social and environmental statements 105 Financial statements of the parentcompany 109 Management’s statement and Auditor’sreports 112 Productoverview 113 More information andreferences ACCOMPLISHMENTS AND RESULTS2015 OURBUSINESS FINANCIAL, SOCIAL ANDENVIRONMENTAL STATEMENTS GOVERNANCE, LEADERSHIPAND SHARES ADDITIONALINFORMATION GLOBAL DEMAND triggers majorproduction investments 38 Tackling the riseof DIABETES INCITIES 30 OBESITY CARE –Buildingthemarketfromscratch 28 GLP-1 –Small protein, bigpotential 26 2015PERFORMANCE and 2016outlook 06 Allreferencescanbefound onp113.
2015 was a good year for NovoNordisk.Thisishow the Board of Directorsseesitwhen taking stockoftheyearthatisnowbehind us. Ihope that youwillagree withus. In a difficult and changing environment for the pharmaceutical industry, NovoNordiskdelivered on the forecasts it made at the beginning of the year, both in terms of sales growth and profit growth. Equally important was the encouraging progress in the company’s pipeline of new and upcoming products, which bodes wellforthefuture. Inhisreviewoftheyearonthefollowing pages, PresidentandCEOLars RebienSørensenhighlights someofthekeydevelopmentsandachieve- ments in2015,including the launch of Saxenda ® forthe treatmentof obesity,theflow ofencouraging phase 2and 3data regarding sema- glutideinbothaninjectableandanoralversionfortype2diabetes,and, ofcourse,thelong-awaitedapprovalofTresiba ® intheUS. Theseachievements aretheresultofaveryrobustlong-termstrategy and excellent execution by the entire Novo Nordisk organisation. Every year we spend a considerable amount of time in board meetings and inmeetings with members of Executive Management reviewing this strategy – challenging assumptions and bringing in new perspectives tobe surenot only that the company’s strategic prioritiesare the right ones, but also that the organisation has the capabilities needed toexecutethem. If you have been following NovoNordiskfor some years, you will notice from the article onpages 16–17that we have not made any significant changes tothestrategy in2015.Thismeans thecompany willretainitssharpfocus onjustfourdisease areas:diabetes, obesity, haemophilia and growth disorders.Many ofourdiscussions lastyear focused on how best toensure that NovoNordiskcan continue its trackrecordof innovation within these areas, so that we will have new and better medicines also in the coming decades for people withtheseseriouschronicconditions.Thisrequiresfurtherexpansion ofourresearchorganisations inEurope, theUSand China, and also that we become even more active in forming partnerships with biotech companies and universities that have knowledge and technologies that complement what wehavein-house. One of the main responsibilities of a board is to ensure that the company has the right executive leadership and that therearesolid succession plans in place for top management . In April, we announced significant changes to the organisation’s leadership, elevating the heads of ourcommercial activities in the US, Europe and International Operations, and of Product Supply to Executive Management . Moreover, Jakob Riis, executive vice president, Marketing, Medical Affairs and Stakeholder Engagement, was given additional responsibility for China, Japan, Korea, Australasia and Canada. The Board also decided that CEOLars Rebien Sørensen should remain inhisroleuntilheapproaches theend ofhiscontract, which expiresin2019. Thesechanges enhance the visibility of NovoNordisk’sinternational business operations to the Board at a time when the company is preparing forglobal launches ofseveralkeyproducts and embarking on an unprecedented investment programme in new production facilities. In addition, they support the further development of our keyleadership talent. Asaresultofthechanges, KåreSchultz,presidentandCOO,decidedto continuehisprofessionalcareeroutsideNovoNordisk.Iwishhimallthe best and thank him for his achievements overmany years at Novo Nordisk.LarsRebienSørensennowhastheadditional roleofchairman oftheOperationsCommittee,withLarsFruergaardJørgensen,executive vicepresident,CorporateDevelopment,asvicechair. In light of Novo Nordisk’s solid performance in 2015, the Board will at the Annual General Meeting propose a 28% increase in dividend to 6.40 Danishkronerpershare.Furthermore,theBoardhas decided to initiatea new sharerepurchaseprogramme ofup to14billionkroner, which willcommence in February2016,and intends tointroducean interimdividendfor2016inAugust2016. Withthefinancial resultsfor2015,wehave achieved the long-term financial targets that we last revisedinJanuary 2013.Inlight of the significant improvement in operating margin during the past years and the need to invest in sustaining sales growth, furtherimprovement of the operating margin is not a strategic priority in the coming years. Reflecting this, we have set the long-term target for operating profit growth at 10%, under- lining our confidence in the growth outlook for thecompany. On behalf of the Board of Directors, I would like toexpressmyappreciation for the leadership shown by Lars Rebien Sørensen and his management team, and for the hard work and dedication of the entireNovo Nordiskorganisation. A GOODYEAR LETTER FROM THECHAIRMAN GöranAndo ChairmanoftheBoardofDirectors 1
Inmyletterinlastyear’sAnnual Report,Ipredicted that2015would beoneofthemostexciting and challenging yearsinNovoNordisk’s 92-yearhistory.Andindeed ithasbeen.Asitturned out, therewere many reasons tobe excited, and we successfully dealt with most of thechallenges. Iwillreturntothe challenges later.Letusstart with the excitement which, toa large extent, was related tonew developments in our product pipeline. Thefact isthat if ourpipeline does not progress well, ifwefail todiscoverand develop new, innovative products for people with diabetes and otherseriouschronicconditions, then we willnotbesuccessful inthelong term.Soletuslookatthehighlights fromourpipeline in2015: • Tresiba ® (insulin degludec) – our new-generation long-acting insulin –was approved in the USin September and launched in January 2016forthetreatment oftype1and type 2diabetes. • Xultophy ® –thecombination ofinsulindegludec and liraglutide for type2diabetes –waslaunched inthefirstEuropean countriesand filed forapproval intheUS. • Following successful completion of the phase 3astudies, we filed forregulatory approval of faster-acting insulin aspart in both the EU and the US for the management of blood glucose around meals forbothtype 1and 2diabetespatients. • Injectable semaglutide –aonce-weekly GLP-1-analogue fortype 2 diabetes –showed superiorefficacy overthecomparator products infourphase 3trialsannounced during theyear. • A once-daily oral formulation of semaglutide showed very encouraging results in a proof-of-concept phase 2 trial, and we subsequently decided to take this product into phase 3 development. • Welaunched Saxenda ® (liraglutide 3mg) intheUSand inthefirst markets outside the US.Saxenda ® isourfirst product for chronic weight management, an undeveloped market despite the huge and growing burden ofobesity allovertheworld. • Welaunched NovoEight ® in the USfor people with haemophilia A, and in January 2016 we filed our long-acting factor IX (nonacog beta pegol) for the treatment of haemophilia B for approval in Europe. Weexpect tofile in the USin the first half of2016. With the number of projects we have in our pipeline these days, one would also expect a number of setbacks. However, we were privileged tohave only one significant disappointment in2015:the results of phase 3 trials showed that liraglutide (Victoza ® ), as adjunct toinsulin therapy, met the primary end-point of improving blood glucose control for people with type 1 diabetes, but unfortunately without the hypoglycaemic benefit experienced in type 2diabetes.Wetherefore decided nottosubmit an application toexpand thelabel ofVictoza ® foruseintype 1diabetes. Ourexpectationisthattherewillcontinuetobeincreasingdemand for ourproductsformanyyearstocome.Thatiswhy,in2015,wedecided onanunprecedentedexpansionofourproductioncapacityfordiabetes, obesity and haemophilia products. Thisincludes investing closeto2 billionUSdollarsin a new sitein Clayton,NorthCarolina,which will produce active pharmaceutical ingredients for both oralsemaglutide andarangeofNovoNordisk’scurrentandfuturediabetescareproducts. Whiledeveloping and making such products will always remain our number one priority, our efforts to change diabetes go beyond medicine. In 2014, we launched Cities Changing Diabetes – a partnership programme to identify and address the rootcauses of type 2diabetes inmajorcitiesaround theworld.Iwas veryhappy to seethe progressalready made when we hosted the inaugural Cities Changing DiabetesSummitinCopenhagen inNovember2015. WhenIreferredto2015 as a challenging yearinthe opening of my letter,I was referring to the challenges of obtaining access to the marketforournewproducts. In2015,wefound ourselvesinincreasingly tougher negotiations with payersintheUStoget ourproductsontotheirformularies.InEurope, China,Japan andmanyothercountries,weareexperiencingcontinued strong pressure on prices and reimbursement restrictionsfor new products.Inone case, forTresiba ® in Germany, we had tomake the difficult decision to discontinue the product following the negative outcome of price negotiations with the statutory health insurance funds.Wewereoffered apriceatthelevelofordinaryhuman insulin, aproductwhich waslaunched inthe1980s.Ifweweretoacceptthis price,wewouldundermineourabilitytoresearchanddevelopmedical innovations forpeople withdiabetes. Thisisan extremecase, but itservesas an example of what could become an unsustainable future for research-based pharmaceutical companies ifpayersandproducerscannotfindcommongroundwhen determining thevalue ofa medicinal product.Thereisnodoubt that we at NovoNordisk,and in the industry at large, need tobecome betteratdemonstrating thevaluethatournewproductsbring.Itisin thislightthatournewpartnershipwithIBMWatsonHealthshouldbe seen.Announced inDecember,thispartnershipwillexplorepossibilities for improved diabetes care via insights from real-time, real-world evidence ofNovoNordiskdiabetes treatmentsanddevices. Despitemarketaccesschallenges, weended theyeargrowing salesby 8%andoperatingprofitby21%,bothinlocalcurrencies.Salesgrowth wasprimarilydrivenbyVictoza ® ,aidedbythehigh growthoftheGLP-1 market, but other products also did well, including Levemir ® , NovoRapid ® ,Tresiba ® and ourhuman growth hormone,Norditropin ® . Measured in local currencies,new-generation insulin accounted for 10% salesgrowth, and Tresiba ® continuestodowellinallthemarkets inwhichitiscompeting onanequalfooting withotherinsulinproducts intermsofreimbursementstatus.Tresiba ® waslaunchedinJapan asthe firstcountryinFebruary2013,and bytheend of2015ithad claimed morethan33%ofthesegment forlong-acting insulin(basalinsulin)in Japan,measuredinvalue. IT’S ALLABOUT INNOVATION LETTER FROM THECEO
Froma regional perspective, NorthAmerica accounted for62% of sales growth, followed by International Operations and Region China.Itisalso inthese regions that we expect tosee most of the growth in the coming years, although we have had to lower our short-term growth projections for China due to a combination of lowereconomic growth, pricing reformsand increased competition frombothlocaland global competitors. In the performance review starting onpage 6 and in subsequent articlesinthisAnnual Report,youcan readmoreabout some ofthe topicsIhave mentioned inmyletter.Ihope theywillgiveyouagood sense of why, despite the challenging business environment forthe pharmaceutical industry,Iremainoptimisticabout thefutureforNovo Nordisk.Theneed formedical treatmentand betterpharmaceuticals isthere,notleastinmanyemerging economies.Wewilldoourbestto meetthese needs and, indoing so,createvalue forourshareholders and forsocietyatlarge bytheknowledge wegenerate, thetaxeswe payandthejobswecreate. So what about 2016? I predict another exciting and challenging year.Therewillbeanintensenewsflowfromourpipeline,including the results of the two large cardiovascular outcomes trials: LEADER regarding Victoza ® and DEVOTE regarding insulin degludec. Plus, ofcourse,therewillbealotofattention onhowTresiba ® performs intheall-important USmarket.Youwillfind atable ofkeypipeline events on page 21and our financial outlook for 2016 on page8. As always, I take great pleasure in working with my Executive Management team, ourSeniorManagement Boardand theBoardof Directorsonmaking themostoftheopportunities and dealing with thechallenges ahead.Asmentioned byourChairman, GöranAndo, in his letter,we had a reorganisation of Executive Management in 2015,which ledtoKåreSchultz, ourchief operating officerformany years, seeking new opportunities outside Novo Nordisk. I have worked with Kåre for as long as I can remember and have great respect forhis capabilities and what he has done forNovoNordisk overtheyears.Iwish him allthebestinhisnewcareer. Lastbutnotleast,IwouldliketothankeveryoneintheNovoNordisk organisation for their contributions to our results in 2015, the people who use our products for their confidence in us, our stakeholders andpartners for their collaboration and our shareholders for their continued support. Lars RebienSørensen President and chief executiveofficer 3
FOCUS VALUE CREATEDRESOURCES Return to shareholders Tax contributions Takingapatient-centredapproach, NovoNordiskprovidesinnovation for the benefit of all of the company’s stakeholders. The Triple Bottom Line principle, anchored in the NovoNordiskWay, is the foundation that makes itpossible tooptimise the use of resources and maximise value creationinasustainable way. OUR BUSINESSMODEL HOW NOVO NORDISK CREATES AND SUSTAINS VALUE Financial resources to invest in R&D, production capacity and customeroutreach INTERNAL Contributions tocommunities Capital provided byinvestors EXTERNAL Biological research and manufacturing facilities Job creation andproductivity A skilled and diverseworkforce Insights from patients and expertise from academic and educational institutions Improved health and quality of life for people with diabetes and other serious chronicdiseases WE DISCOVER, DEVELOP AND MANUFACTURE INNOVATIVE BIOLOGICAL MEDICINES AND MAKE THEM ACCESSIBLE TO PATIENTS THROUGHOUT THEWORLD Capacity and competencebuilding NOVO NORDISK ATAGLANCE NovoNordiskisa global healthcare company with morethan 90 yearsof innovation and leadership indiabetes care.Thisheritage has given usexperienceand capabilities thatalso enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. For more information, visit novonordisk.com, Twitter, LinkedIn, YouTubeandFacebook. CORPORATE STRATEGY NOVO NORDISKWAY Rawmaterials PATIENTS
A GLOBAL ORGANISATION WITH A LOCAL PRESENCE HEADQUARTERED INDENMARK ESTABLISHED IN1923 PRODUCTSMARKETED IN 180+COUNTRIES AFFILIATESOR OFFICESIN 75COUNTRIES RESEARCHAND DEVELOPMENT FACILITIESON 3CONTINENTS THE TRIPLE BOTTOMLINE 41,122 employees (+5%) * 26.8 million patientsuseour diabetes careproducts (+10%) 8.6 DKK billion expensed in company income tax(+13%) 34.9 DKK billion in netprofit (+32%) 107 thousand tons of CO 2 emissions (–11%) 3,131 thousand m 3 water consumption (+6%) SOCIALLY RESPONSIBLE ENVIRONMENTALLY RESPONSIBLE THE PEOPLE WE FOCUSON 415 MILLION PEOPLE LIVEWITH DIABETES 1 0.4 MILLION PEOPLE LIVEWITH HAEMOPHILIA 3 FINANCIALLY RESPONSIBLE 600 MILLION PEOPLE LIVEWITH OBESITY 2 3 OUT OF 10,000 CHILDREN LIVEWITH GROWTH DISORDERS 4 * Excluding employees in NNIT A/S, witch was divested in2015. 5
2015PERFORMANCE AND 2016OUTLOOK FINANCIAL PERFORMANCE 2011 2012 2013 2014 2015 0 5 10 15 20 SALESGROWTH • In localcurrencies • In DKK asreported % 25 2011 2012 * 2013 2014 * 2015 0 20 40 60 80 100 SHARE OF GROWTH IN LOCAL CURRENCIES Japan &Korea RegionChina International Operations Europe NorthAmerica % *In2012and2014,Japan &Koreacontributed–1%tothetotalgrowth. 2011 2012 2013 2014 2015 0 25 50 75 100 125 SALES BYSEGMENT Biopharmaceuticals Diabetes and obesitycare DKKbillion NovoNordisk’s2015performancewasinline withthelatestguidance providedinOctober. SALESDEVELOPMENT Salesincreasedby22%inDanishkronerand by 8% measured in local currencies. North Americawasthemain contributorwith62% shareofgrowthmeasuredinlocalcurrencies, followed by International Operations with 26%. Sales growth was realisedwithin both diabetes care and biopharmaceuticals, with the majority of growth originating from modern insulinandVictoza ® . In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from November 2015 and November 2014 provided by the inde- pendent data providerIMSHealth. DIABETES AND OBESITY CARE,SALESDEVELOPMENT Sales of diabetes and obesity careproducts increased by 22% measured in Danish kronerand by9% inlocalcurrenciestoDKK 85,590 million. NovoNordiskis the world leader in diabetes care and holds a global value market share of 28%, compared to 27% at the same time last year. Sales of new-generation insulin (Tresiba ® , Ryzodeg ® and Xultophy ® )reached DKK1,438 million, compared with DKK658 million in2014. INSULIN The roll-out of Tresiba ® (insulin degludec), the once-daily new-generation basal insu- lin, continues and the product has now been launched in 39 countries, including Spain and the US, with initial encouraging market access. In Japan, where Tresiba ® was launched inMarch 2013 with thesame level of reimbursement as insulin glargine, its share of the basal insulin market has grown steadily, and Tresiba ® has captured 33% of the market measured in monthly value market share. Similarly, Tresiba ® has shown solid penetration in other markets with reimbursement at a similar level to insulin glargine, whereas penetration re- mains modest in markets with restricted market access compared with insulin glargine. Novo Nordisk has ceased distri- bution of Tresiba ® in Germany in January 2016 as a result of the negative outcome from price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV). Ryzodeg ® , a soluble formulation of insulin degludec and insulin aspart, was recently launched in Japan as the third market following launches in Mexico and India. Launch activities areprogressing asplanned and early feedback from patients and pre- scribersisencouraging . Xultophy ® ,aonce-dailysingle-injection com- bination of insulin degludec (Tresiba ® ) and liraglutide (Victoza ® ), has been marketed in Switzerland, Germany, theUKand Sweden. Launch activities areprogressing asplanned, and also here, earlyfeedback from patients and prescribersisencouraging . Sales ofmodern insulin increased by21%in Danishkronerand by7% inlocal currencies to DKK 50,164 million. North America accounted for66% ofthegrowth, followed by International Operations and Region China. Sales of modern insulin and new- generation insulin now constitute 82% of NovoNordisk’ssalesofinsulin. VICTOZA ® (GLP-1THERAPY FORTYPE 2DIABETES) Victoza ® sales increased by 34% in Danish kroner and by 18% in local currencies to DKK18,027 million. Sales growth is driven by North America as well as positive contributions from Europe, Japan & Korea and International Operations. The GLP-1 segment’s value share of the total diabetes care market has increased to 7.8%, com- pared with 7.0% in 2014. Victoza ® is the marketleader intheGLP-1segment, with a 67%value marketshare. OTHER DIABETES AND OBESITY CARE Sales of other diabetes and obesity care products, which predominantly consist of oral antidiabetic products, needles and Saxenda ® , increased by 16% in Danish kroner and by 5% in local currenciesto NOVO NORDISK ANNUAL REPORT2015 6 ACCOMPLISHMENTS AND RESULTS2015
2011 2012 2013 2014 2015 0 10 20 30 40 0 10 20 30 DKKbillion NETPROFIT • Net profit margin (right) Net profit(left) 2011 2012 2013 2014 2015 0 10 20 30 40 DEVELOPMENT INCOSTS Costs in % of sales • Sales and distribution • Cost of goods sold • Research and development • Administration % 2011 2012 2013 2014 2015 0 10 20 30 40 50 0 10 20 30 40 OPERATING PROFIT • Operating profit margin (right) Operating profit(left) DKKbillion % 50 % 40 DKK4,730 million.Thisreflects asignificant positive contribution from the USlaunch of Saxenda ® , liraglutide 3 mg for weight management, in May 2015. In the US, Saxenda ® has broad market access in the commercial segment, launch activities are progressing as planned and feedback from patients and prescribers is encouraging . Declining sales of needles in Europe and oral anti-diabetics in North America and International Operations partly offset sales growth. BIOPHARMACEUTICALS SALESDEVELOPMENT Sales of biopharmaceutical products in- creased by19% measured inDanishkroner andby6% inlocalcurrenciestoDKK22,337 million. Sales growth is primarily driven by North America, International Operations andEurope. HAEMOPHILIA Sales of haemophilia products increased by 14% in Danish kroner and by 3% in local currenciestoDKK10,647million.Thegrowth in local currenciesisprimarilydriven by the roll-out of NovoEight ® in Europe, Japan and the US as well as by NovoSeven ® in Inter- national Operations, partly offset by lower NovoSeven ® salesintheUSandJapan. NORDITROPIN ® (GROWTH HORMONE THERAPY) Sales of Norditropin ® increased by 20% in Danishkronerand by8% inlocal currencies to DKK7,820 million. The sales growth is primarily derived from North America, reflecting favourable pricing and increased demand driven by the pre-filled FlexPro ® device aswellasLatinAmerican and Middle East markets in International Operations. NovoNordiskistheleading company inthe global growth hormone market,witha32% marketsharemeasured involume. OTHER BIOPHARMACEUTICALS Sales of other products within biopharma- ceuticals, which predominantly consist of hormone replacement therapy-related (HRT) products, increased by 28% in Danish kroner and by 13% in local currencies to DKK3,870 million.Sales growth isdrivenby a positive impact from pricing of Vagifem ® intheUS. DEVELOPMENT IN COSTS AND OPERATINGPROFIT Thecostof goods soldincreased by11% to DKK 16,188 million, resulting in a gross margin of 85.0%, compared with 83.6% in 2014.Thisreflectsapositivecurrencyimpact of 1.5 percentage points and a positive impact from the product mix, primarilydue to increased sales of Victoza ® and modern insulin. Thisis countered by ramp-up costs fornewmanufacturing capacity. Sales and distribution costs increased by 22% in Danish kroner and by 9% in local currencies to DKK 28,312 million. The increaseincostsisdrivenbyUSlaunch costs related to Saxenda ® and NovoEight ® and by preparations for the Tresiba ® launch in the US, sales force investments in selected countriesinInternational Operationsaswell asadjustments tolegal provisions. Research and development costs decreased by1% inDanish kronerand by6% inlocal currencies toDKK13,608 million.Excluding all costs related to inflammatory disorders, an area which Novo Nordisk exited in September 2014,researchand development costs increased by 8% compared to 2014. Theincrease inunderlying costsreflects the progression of the late-stage diabetes care portfolio and is primarily driven by the cardiovascular outcomes trial DEVOTEfor insulin degludec and the phase 3a pro- gramme SUSTAINfortheonce-weeklyGLP-1 analogue semaglutide.Theincrease incosts is partly offset by lower costs related to faster-acting insulin aspart following the completion of the phase 3a development programme onsetinAugust2015. Administration costs increased by 9% in Danishkronerand by4% inlocal currencies toDKK3,857 million. Other operating income (net) was DKK 3,482 million, compared with DKK 770 million in2014.Theincreaseisdrivenbythe DKK 2,376 million non-recurring income fromthepartial divestment ofNNITA/S, an IT service and consultancy company, in connection with the Initial Public Offering on Nasdaq Copenhagen under the symbol ‘NNIT’(ISINDK0060580512) as well as the DKK 449 million non-recurring income related to the out-licensing of assets for inflammatory disorders. Operating profitincreasedby43% inDanish kroner to DKK 49,444 million. In local currencies the growth was 21%, which is slightly higher than the latest guidance for operating profit growth measured in local currenciesfor2015of‘around20%’.Adjusted for the income related to the partial divestment of NNITA/S, the growth in operating profitwas14%inlocalcurrencies. NETFINANCIALSANDTAX Net financials showed a net loss of DKK 5,961 million, compared with a net loss of DKK396 million in 2014.Thereported net financial lossin2015islargerthan thelatest guidance of ‘around DKK 5.6 billion’, primarily reflecting higher than expected lossesoncommercial balances following the depreciation of the Argentine peso in December 2015 as well as an effect from the depreciation of the Russian rouble and the Brazilian real during the fourth quarter of2015. CONTINUED NOVO NORDISK ANNUAL REPORT2015 ACCOMPLISHMENTSANDRESULTS2015 7
In line with NovoNordisk’streasury policy, the most significant foreign exchange risks for the Grouphave been hedged, primarily through foreign exchange forwardcontracts. The foreign exchange result was a loss of DKK5,898 million compared with a lossof DKK381 million in 2014. Thisdevelopment reflects losseson foreign exchange hedging involving especially the USdollar due to its appreciation versus the Danish krone com- pared with the prevailing exchange ratesin 2014.Asof 31 December2015,foreign ex- change hedging losses of around DKK700 millionhave been deferredforrecognition in theincomestatement in2016. Theeffective taxratefor2015 was 19.8%, which isinlinewith thelatestguidance ofa tax rate of ‘around 20%’ for the full year 2015.Thelowertaxratecompared with the 2014 level of 22.3% primarily reflects the tax-freegain from the partial divestment of NNITA/S, the gradual reduction of the corporateincome taxrateinDenmark from 24.5% in2014 to23.5% in2015 aswellas changes inprovisionsrelatedtointernational taxcases. CAPITAL EXPENDITURE AND FREE CASHFLOW Net capital expenditure for property, plant andequipmentwasDKK5.2billion,compared with DKK4.0billionin2014,which isinline with thelatestguidance of‘around DKK5.0 billion’.Netcapital expenditurewas primarily related to investments in additional insulin filling capacity, expansion of the manufac- turing capacity forbiopharmaceutical prod- ucts and the construction of new research facilities. Freecash flow was DKK34.2 billion, com- pared with DKK27.4billion in 2014,which is in line with the latest guidance of ’DKK 33–35 billion’. The increase of 25% com- pared with 2014 primarily reflects the increased cashflowfromoperating activities as well as the non-recurring proceeds from thepartial divestment ofNNITA/S. OUTLOOK2016 Sales growth for2016isexpected tobe 5– 9% measured in local currencies. This reflects expectations for continued robust performance for the portfolio of modern insulin, Victoza ® and Tresiba ® aswell as a contribution from Saxenda ® and Xultophy ® . Thesesales driversareexpected tobepartly counteredbyan impact froma contractloss in the US, healthcare reforms, the loss of exclusivity for products within hormone replacement therapy, intensifying compe- titionwithindiabetesandbiopharmaceuticals as well as macroeconomic conditions in China and a number of markets in Inter- national Operations.Given the currentlevel of exchange rates versusthe Danish krone, growth reported in DKKis expected to be around 1 percentage point lower than the localcurrencylevel. For 2016, operating profit growth is expected to be 5–9% measured in local currencies, adjusted by DKK2,376 million for the partial divestment of NNITA/S and byDKK449 millionfortheincomerelatedto the out-licensing of assets forinflammatory disorders, both in 2015. The expectations for operating profit growth reflect growth in selling and distribution costs to support continued launch activities as well as in research and development costs tosupport the progress of Novo Nordisk’s pipeline. Given the current level of exchange rates versustheDanishkrone,growth reportedin DKKisexpected tobearound 1percentage point lowerthan thelocalcurrencylevel. For2016,NovoNordiskexpectsanetfinancial loss of around DKK1.3 billion. Thecurrent expectation primarilyreflectslossesassociat- edwithforeign exchange hedging contracts, mainlyrelatedtotheappreciationofthe US dollar versus the Danish krone compared to theprevailingexchange ratesin2015. The effective tax rate for 2016 is expectedto beintherangeof20–22%. Capitalexpenditureisexpectedtobearound DKK7.0 billion in 2016, primarilyrelated to investments in an expansion of the manu- facturing capacity for biopharmaceutical products, additional capacity for active pharmaceutical ingredient production within diabetes care, an expansion of the insulin filling capacity and construction of new researchfacilities.Depreciation,amortisation and impairment losses are expected to be around DKK3.0 billion. Free cash flow is expected tobeDKK36–39billion. Allof the above expectations arebased on the assumption that the global economic environment will not significantly change business conditions forNovoNordiskduring 2016, and that currency exchange rates, especially the US dollar, will remain at the currentlevelversustheDanishkrone. NovoNordiskhashedged expected netcash flows in a number of invoicing currencies and, allotherthings being equal, movements inkeyinvoicing currencieswillimpact Novo Nordisk’soperating profitasoutlined inthe table totheleft. LONG-TERM FINANCIALTARGETS Novo Nordisk introduced four long-term financial targets in 1996 to balance short- and long-term considerations, thereby ensuring a focus on shareholder value creation. The targets were subsequently revised and updated on several occasions, mostrecentlyinconnection with theannual resultsfor2012released inJanuary 2013. *USDandChineseyuantradedoffshore(CNH)usedasproxywhenhedging NovoNordisk’sCNY currencyexposure. KEYINVOICING CURRENCIES ANNUAL IMPACTONNOVO NORDISK’S OPERATING PROFITOFA5% MOVEMENT INCURRENCY HEDGING PERIOD (MONTHS) USD DKK 2,000 million 12 CNY DKK 300million 11 * JPY DKK 150million 12 GBP DKK 85million 11 CAD DKK 70million 11 EXPECTATIONS ARE ASREPORTED, IF NOT OTHERWISE STATED EXPECTATIONS 3 FEBRUARY 2016 5–9% Around1percentage pointlower Salesgrowth • inlocal currencies • asreported Operating profit growth* • inlocal currencies • asreported Net financials Effective tax rate Capital expenditure Depreciation, amortisation and impairment losses 5–9% Around1percentage pointlower LossofaroundDKK1.3billion 20–22% Around DKK7.0billion AroundDKK3.0billion OUTLOOK2016 The current expectations for 2016 are summarised in the table below: Freecashflow DKK 36–39billion *AdjustedDKK2,376 millionforthepartialdivestmentofNNITA/SandDKK449millionfortheincomerelatedtotheout-licensing ofassetsforinflammatory disorders,bothin2015. NOVO NORDISK ANNUAL REPORT2015 8 ACCOMPLISHMENTS AND RESULTS2015
Thetargetlevelforthecashtoearnings ratio is maintained at 90%, as expected contin- ued growth in International Operationsand expanding investment prioritieswillgradually impact net operating assets. As previously, and given theinherentvolatilityinthisratio, the target will be pursued looking at the average overa three-yearperiod. FORWARD-LOOKING STATEMENTS Novo Nordisk’s reports filed with or furnished totheUSSecuritiesand Exchange Commission (SEC),including this document and Form 20-F, both expected to be filed with the SECinFebruary 2016,and written information released, or oral statements made, tothe public in the future by oron behalf of Novo Nordisk, may contain forward-looking statements.Wordssuch as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of similar meaning in connection with any discussion offutureoperating orfinancial performance identify forward-looking statements. Examples of such forward-looking state- ments include, but are not limitedto: • statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and product approvals as well as cooperation in relationthereto • statements containing projections of or targets for revenues, costs,income (or loss), earnings per share,capital expenditures, dividends, capital structure, net financials andother financial measures • statements regarding future economic performance, future actions andoutcome of contingencies, such as legal proceedings • statements regarding the assumptions underlying or relating to suchstatements. In 2015, NovoNordiskreached these four long-termfinancialtargetsandconsequently, the Board of Directorshas approved three updated long-term financial targets to guide Novo Nordisk’s performance. The targets have been revised based on an assumption ofa continuation ofthecurrent business environment. Significant changes tothe business environment, including the structure of the US healthcare system, regulatory requirements, pricing and market access environment, competitive environ- ment, healthcare reforms, exchange rates and changes to accounting standards may significantly impact the time horizon for achieving the long-term targets or require them toberevised. Thetargetlevelforlong-termoperatingprofit growth has been setat 10%, reflecting the currentoutlookfororganic salesgrowth and opportunities foroperating marginleverage. NovoNordisk’scurrentoperatingmarginlevel of43.6%(adjustedfortheeffectofthepartial divestmentofNNITA/S)hasbeenachievedby continuous improvement in manufacturing efficiency, positive pricing impact, sales and distributionleverage, reprioritisationoffocus areas within researchand development as well as administrative efficiencies. It is a strategic priority to continue to invest in future organic sales growth, and as a consequence operating margin improvement isnotexpected tobea majorcontributorto operating profit growth. This expectation reflects an expanded product portfolio, a significant number of product launches and continued investments within research and development. Consequently, no target for operating margin has been established, as the operating margin isexpected toremain atthecurrentlevelaround44%. The target level for operating profit after taxtonetoperating assets isunchanged at 125%. The target reflects the expecta- tion of a continued robust operating profit growth combined with a stable effective taxrateand gradual increase innet operat- ing assets, partly related to an expanded fixed asset investment to sales ratio to ac- commodate future sales growth, primarily within diabetes care. In this document, examples of forward- looking statements can be found under the heading ‘2015 performance and 2016 outlook’ and elsewhere. These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions thatanumber ofimportant factors, including those described inthisdocument, couldcauseactual resultstodiffer materially from those contemplated in any forward- looking statements. Factors that may affect future results include, butarenotlimited to,global aswell as local political and economic conditions, including interest rate and currency ex- change ratefluctuations, delay orfailure of projects related to research and/or devel- opment, unplanned loss of patents, inter- ruptionsofsupplies andproduction, product recalls, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’sproducts, introduction ofcompet- ing products, reliance on information tech- nology, NovoNordisk’sability tosuccessfully marketcurrentand new products, exposure to product liability and legal proceedings and investigations, changes ingovernmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth incostsand expenses, failure torecruitand retain the right employees, and failure to maintain a cultureofcompliance. Please also refer to the overview of risk factors on pp42–43. Unless required by law, Novo Nordisk is undernodutyand undertakes noobligation to update or revise any forward-looking statement afterthedistribution ofthisdocu- ment, whether as a result of new infor- mation, future events orotherwise. PERFORMANCE AGAINST LONG-TERM FINANCIAL TARGETS Result 2015 Average 2012–2015* Previous target Updated target Operating profitgrowth 43% 23% 15% 10% Operatingmargin 46% 40% 40% N/A** Operating profit after tax to net operating assets 149% 111% 125% 125% Cash toearnings 98% Cash to earnings (three-yearaverage) 97% 97% 90% 90% *Calculatedasasimpleaverage. ** Anewtargethasnotbeenestablished, asoperating margin isexpectedtoremainaround44%. NOVO NORDISK ANNUAL REPORT2015 ACCOMPLISHMENTSANDRESULTS2015 9
RESEARCH ANDDEVELOPMENT 2011 2012 2013 2014 2015 0 5 10 15 20 25 30 Thousand * A patient year is measured as the total number of months a patient is enrolled in a clinical trial divided by 12. 2015 was a year in which Novo Nordisk made significant progressinitsresearchand development pipeline and reached several milestones. Belowarethehighlights fromthekeydevel- opment projects. On p 20, the pipeline overview shows all the compounds in clinical development, and further details on clinical trials can be found in the company announcements and press releases pub- lished by NovoNordiskduring 2015, which areavailable onnovonordisk.com. DIABETES In March 2015, Novo Nordisk decided to resubmit New Drug Applications (NDA)of Tresiba ® and Ryzodeg ® 70/30 intheUS. The resubmission was based on the interim analysis ofthecardiovascular outcomes trial for Tresiba ® , DEVOTE. In order to preserve the integrity of the ongoing DEVOTEtrial, only a small team within NovoNordiskhad access to the data and made the decision to resubmit the NDA. NovoNordisk man- agement doesnothave accesstotheresults of the interim analysis. TheDEVOTEtrial is expected tobe completed in mid-2016 and theresultsareexpected tobeannounced in thesecond half of2016. Based on the class IIresubmission, the US Food and Drug Administration (FDA) approved Tresiba ® and Ryzodeg ® 70/30 for the treatment of diabetes in adults in September 2015. Following the approval, Tresiba ® was introduced to diabetes care specialists inthe USduring November2015 and was launched broadly inJanuary2016. trial programme, which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements inpostprandial controlversus NovoRapid ® and an HbA 1c reduction on par with NovoRapid ® . Across the onset trials, faster-acting insulin aspart had a safe and well-toleratedprofile,withthemostcommon adverse event being hypoglycaemia similar tothelevelsobserved withNovoRapid ® . OBESITY In March 2015, the European Commis- sion granted marketing authorisation for Saxenda ® (liraglutide 3 mg) for the treatment of obesity. Saxenda ® is the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity approved in Europe. Saxenda ® is indicated in the EU as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of =30 kg/m 2 (obese), or =27 kg/m 2 to <30 kg/m 2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia, hypertension, dys- lipidaemia or obstructive sleep apnoea. Saxenda ® was launched in Denmark in August 2015. Earlier in the year, during May, Saxenda ® had already been launched intheUS,following theUSFDAappro- val in December 2014. Novo Nordisk will continue the global roll-out of Saxenda ® during 2016 and expects tolaunch itin up totencountries. HAEMOPHILIA In January 2016, Novo Nordisk submitted the MAA to the EMA for the approval of long-acting factor IX,nonacog beta pegol. Nonacog beta pegol is a glycopegylated recombinant factor IXwith a significantly improved pharmacokinetic (PK)profile, de- veloped for patients with haemophilia B. NovoNordiskexpects to file the Biologics License Application (BLA)fornonacog beta pegol to the US FDAduring the first half of2016. New data for long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) was reported from the first part of the pathfinder™2 extension trial in November 2015. Thereported data provide additional support that N8-GP(turoctocog alfa pegol) appeared tohave a safe and well-tolerated profile, and that 95% of mild tomoderate bleeds can bemanaged with 1–2infusions. In January 2016, the results from the double-blinded phase 3b trial SWITCH2 were announced. The primary endpoint of the trial was met by showing a statistically significantly lower rate of severe or blood glucose confirmed symptomatic hypogly- caemia during the maintenance period of 30% for people treated with Tresiba ® compared toinsulinglargine. In August 2015, Novo Nordisk decided to initiate a phase 3a programme with oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analogue sema- glutide. The decision followed the encour- aging resultsof the proof-of-concept phase 2trialannounced inFebruary 2015 and the subsequent consultations with regulatory authorities. The successful phase 2 trial resultsmarkasignificant milestone forNovo Nordisk in its ambition to deliver protein- based medicine, like semaglutide, in the form of a tablet and producing it in large scale. Novo Nordisk intends to initiate a global phase 3a programme, named PIONEER, comprising ten trialswith more than 9,000 people with type 2 diabetes. ThePIONEER programme will include nine safety and efficacy trialsand onetrialforevaluating the cardiovascular safety of oral semaglutide. In September 2015, NovoNordiskfiled the NDAtothe USFDAforXultophy ® ,the first once-daily single-injection combination of Tresiba ® (insulin degludec) and Victoza ® (liraglutide). The submission is currently being reviewedundertheUSFDA’sPrescrip- tionDrugUserFeeActV(PDUFAV). PATIENTYEARS INCLINICAL TRIALS * Japan &Korea RegionChina International Operations Europe NorthAmerica During the second half of 2015, Novo Nordiskcompleted fouroutofsixphase 3a trials with semaglutide in the SUSTAIN programme. Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly forthetreatment oftype 2diabetes in adults. Thedata reported so far confirm the strong efficacy profile of semaglutide, which alsoappeared safe and welltolerated inthetrials. InDecember2015,NovoNordisksubmitted the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA)and theNDAtotheUSFDAforfaster- acting insulin aspart. Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions and has been developed for the treatment ofpeople withtype1and type2diabetes. The filing of faster-acting insulin aspart is based on the results from the onset clinical NOVO NORDISK ANNUAL REPORT2015 10 ACCOMPLISHMENTS AND RESULTS2015
CONTINUED SOCIALPERFORMANCE Social performance has three dimensions: improving access tomedical treatment and quality of care for patients, offering a healthy and engaging working environment, and providing assurance that responsible business practices areinplace, with theaim ofcontributing tothecommunities inwhich thecompany operates. PATIENTS Justoverhalf ofthe415millionpeople living with diabetes 1 are diagnosed, and many of those diagnosed do not receive medical treatment. AspartofNovoNordisk’sstrategyforglobal accesstodiabetes care,thecompany hasset itself the long-term target of reaching 40 millionpeople withitsdiabetes careproducts by2020,whichisdoublethebaselinenumber in 2010. Theaim istoenable more people withdiabetes toreceivemedicaltreatment. In 2015, Novo Nordisk provided medical treatments toan estimated 26.8 million pa- tients with diabetes worldwide, compared with 24.4 million in 2014, calculated based on WHO’srecommended daily doses for diabetes medicines.Thenumber reflects an overallincrease inthe number of pa- tients treatedwithNovoNordisk’sinsulin products and was driven by human insulin in International Operations (1.2 million pa- tients)and modern and new-generation in- sulins globally (0.9 million patients). Novo Nordiskfocuses onenhancing quality ofcare through productinnovation, whileremaining committed to expanding access to medical treatment and careforpatients with diabe- testhroughout the world.Thecompany has several programmes specifically targeting people inlow-and middle-income countries who have limitedaccesstohealthservices. NovoNordisksold human insulin according tothecompany’s differential pricingpolicyin 23 of the world’s 48 poorestcountries(the LeastDevelopedCountries–LDC),compared with 32 countriesin2014.According tothis policy, the priceshould not exceed 20% of theaverage insulinpriceinthewesternworld (defined astheEU,Norway,Switzerland, the US, Canada and Japan). In 2015, the LDC ceiling priceforinsulintreatment perpatient per day was USD0.19, while the average realised price for insulin sold under the programme was USD0.15,corresponding to USD3.85 per vial. Thedecline is attributed tofewer insulintendersin2015and lack of response from governments or private wholesalers and other partners to Novo Nordisk’soffer.Thetotalnumber ofpatients treatedwith insulinssoldat orbelow ceiling price was approximately 411,000 in 2015, which is a slight decrease compared with approximately431,000 in 2014. Beyond this scheme, NovoNordisksellshuman insulin at similar prices in low-income countries. In 2015,an estimated 5.5millionpatients have beentreatedwithinsulinforUSD0.19perday orless, corresponding toa priceper vial of USD4.81orless.Incomparison,anestimated 4.3millionpatients weretreatedwith insulin atorbelowtheceilingpricein2014. Bytheend of2015,continued progress had been achieved by Changing Diabetes ® programmes withtheaim ofreaching more people with diabetes and building capacity. The Changing Diabetes ® in Children programme has been rolled out in nine countries since its launch in 2009, reach- ing more than 3,400 children, who receive insulintreatmentfreeofcost.Atotalof108 clinics have been established, and more than 6,500 healthcare professionals have been trained or re-trained. The Changing Diabetes ® in Pregnancy programme, also launched in 2009, has since screened more than 33,300 women forgestational diabetes mellitus, and morethan 3,800 women have been diagnosed and subsequently treated. The Base of the Pyramid programme has, since its launch in 2011, established seven DiabetesSupportCentresinNigeriaandsixin Ghana.Theprogramme has been scaled up inKenyatobuildcapacity and ensuresupply. Furthermore,twonew Centresof Excellence inDiabetescarewerelaunched intheKenyan publicsectoratcountylevelin2015. In 2014, Novo Nordisk launched Cities Changing Diabetes– a cross-disciplinaryand cross-sectorpartnership programme toiden- tify and address the rootcauses of the rise in type 2 diabetes in urban areas. The programme is currently running in Mexico City, Copenhagen, Houston, Tianjin and Shanghai, representingmorethan 60 million inhabitants. In 2016, they will be joined by VancouverandJohannesburg .Theaimofthe programme istodrivetransformative action through new research focusing on cultural determinants and social factors that will facilitate the implementation of integrated andsustainable solutionsincities. Donations through the World Diabetes Foundation (WDF)amounted to DKK 78 million in2015.TheWDFisan independent non-profit organisation established byNovo Nordiskin 2002 to help expand access to diabetes care. The foundation invests in sustainable initiatives to build healthcare capacity, with the aim of improving pre- vention and treatment of diabetes in de- veloping countries. In 2015, the WDFsup- ported 22 new projects. These included projects with a focus on prevention and others aimed at reaching people in the most remote rural areas. Read more on worlddiabetesfoundation .org. NovoNordiskalsoprovidesfinancial support to improve global access to haemophilia care. In 2015,thecompany donated DKK 19 million to the Novo Nordisk Haemo- philia Foundation, established in 2005. The foundation supports projects and fellow- ships in developing and emerging econ- omies.Initiatives focus oncapacity building, awareness, diagnosis and patient registries. Readmoreonnnhf.org. EMPLOYEES At the end of 2015, the total number of employees was 41,122, corresponding to 40,638 full-time positions, which is a 1% decrease compared with 2014 due to the divestment of NNITA/S in March 2015. The underlying growth (5%) is primarily driven by expansion within the sales region International Operations and in Denmark, primarily within research & development andproduction. Employee turnover increased from 9.0% in 2014 to 9.2% and was primarily driven by Region China.Inpreviousyearstheturnover ratehas been8–10%. The consolidated score in the annual em- ployee survey, eVoice, was 4.3 as in 2014, measured ona scale of1to5,with5being the best score. The survey measures the extenttowhich theorganisation isworking in accordance with the NovoNordiskWay. The2015 resultreflectsastrong cultureand commitment tothecompany’s values. To ensure a robust pipeline of talent for management positions, anew aspiration has beensetthatstrivesforenhanced diversityin all management teams, including entry-level andmiddlemanagement .Bytheendof2015, the gender diversity among managers was 59% men and 41% women. Ofthe newly promotedmanagers, 44%werewomen. Tragically,a salesrepresentativeinIndia died inatrafficaccidentwhileondutyin2015.The 2015average frequency rateofoccupational accidents with absence decreased to 3.0 per millionworking hours,compared with NOVO NORDISK ANNUAL REPORT2015 ACCOMPLISHMENTS AND RESULTS 2015 11
2011 2012 2013 2014 2015 0 10 20 30 40 50 PATIENTS REACHED WITH DIABETES CAREPRODUCTS Estimate • Realised Target(2020) Million 2011 2012 2013 2014 2015 1 2 3 4 5 WORKING THENOVONORDISK WAY Average score in annual employee survey • Realised Target Scale 3.2in2014.NovoNordiskisworkingwith a zero-injury mindset, and the long-term commitment istocontinuously improveper- formance. Focus is on strengthening risk awareness and preventing occupational acci- dentsforallemployees. ASSURANCE Training in business ethics is mandatory and a high priority. Annual business ethics training is required for all employees, in- cluding new hires. Business ethics training is also a key element of the onboarding programmes.In 2015,as in 2014,98% of all relevant employees completed and documented their training, and passed the related tests.Thishigh level isattributed to the constant focus and communication by senior management on the importance of business ethicscompliance. Adherence to the company’s global stan- dards for ethical behaviour must be ob- served and is monitored. Internal business ethics assurance activities are conducted using on-siteinterviews and documentation reviews to assess adherence to compliance requirements and internal procedures. During 2015, 49 business ethics assurance reviewswereconducted, compared with 42 in2014. During the year, the global facilitator team conducted 65 audits ofunits’ adherence to the Novo Nordisk Way, so-called facil- itations, covering approximately 18,500 employees, 15%ofwhom wereinterviewed. Thefacilitations conducted in2015 showed a high level of compliance with the Novo Nordisk Way. A facilitation consists of document review and interviews with local management, employees and stakeholders todetermine the level of adherence tothe corporate values and expected behaviours spelled outintheNovoNordiskWay. Best practices are shared internally, while findings of non-compliance are reported to localmanagement, which mustsubsequently implement correctiveactions. In2015, 94% of actions wereclosed on time.Asummary report,presented tothe Boardof Directors, outlines key observations and trends across all facilitations, and the conclusion is that therewasahigh levelofcompliance withthe NovoNordiskWayacrosstheorganisation in 2015.TheEssentials, of which thereare10, arethe basis forthe implementation of the NovoNordiskWay.See the article on p 18 and novonordisk.com/about-novo-nordisk/ novo-nordisk-wayforadditionalinformation. Atotalof240supplierauditswereconducted toassess theirlevel of compliance with the company’s standards for suppliers. These relatetoquality aswellastheenvironment, labour, human rights and business ethics, in line with Novo Nordisk’s responsible sourcingpolicy. These audits are undertaken by Novo Nordisk’s global quality organisation. The levelofaudit activitywasupfrom224audits in 2014 due to Management’s decision to build new factories. Of the audits carried outin2015,28werefocused onresponsible sourcing criteria, which is a slight increase compared with25audits in2014.Onlyhigh- risk suppliers, identified through a robust riskassessment, areselected forresponsible sourcing audits. One critical finding was identified in connection with a quality audit in 2015. A continuous improvement and engagement programme has been initiated withthesupplierinordertoaddresstheissue. In2015,asin2014,NovoNordiskhad two product recalls from the market. Both recallswererelated toincorrectlabelling of products. Local health authorities were informed in both instances to ensure that distributors, pharmacies, doctors and pa- tients receivedappropriate information. In 2015, as in 2014, there were no failed inspections among those resolved at year- end. Inspections are measured in relation to the US Food & Drug Administration, European Medicines Agency (EMA), the Japanese Pharmaceuticals &Medical Devices Agency (PMDA), Lloyd’s Register Quality Assurance (LRQA)and domestic authorities forstrategic manufacturing sites.Atotal of 82 inspections were conducted in 2015 at Novo Nordisk sites, at clinics conducting investigations for Novo Nordisk or for voluntary ISO9001 certification, compared with59inspections in2014.Atyear-end,57 inspections had been passed and 25 were unresolved. NovoNordisk is implementing its commit- ment torespect human rights assetout in the UNGuiding Principles on Business and Human Rights. The human rights due diligence started with a Group-wide human rights impact assessment against all internationally recognised human rights. NovoNordiskrecognises that the company has a number of potential impacts with regard toa range ofhuman rights, right to health, right to privacy, right to a living wage, and safe and healthy working conditions.Theassessment has shown that strong management systems are in place. Vigilance and continuous improvements are partofongoing efforts. Acompany’s reputation with its key stake- holdersisanindicatoroftheextenttowhich the company lives up to expectations. The better the reputation, the more likely it is that these stakeholders will trust, support and engage with the company. Novo Nordisk measures its reputation with key stakeholders annually using the RepTrak ® methodology developed by Reputation In- stitute.Reputation ismeasured onascaleof 0–100 and a scoreabove 80 is considered excellent.In2015,thescorewas 82.4,com- pared with 80.8in2014. LONG-TERM SOCIALTARGETS Novo Nordisk has chosen two long-term social targets to support long-term finan- cial performance, balancing responsibility with profitability, with the aim of creating sustainable value forshareholdersand other stakeholders.Thesocialtargetsreflectaspira- tions expressed in the Novo NordiskWay: helping people livebetter livesand working theNovoNordiskWay.Thelong-termpatient target is expected to be met. Development year on year will vary, reflecting gains and lossesoflargetendersandcontracts. Foradditional information about the social performance, seethesocialstatement onpp 96–101 and the UNGCCommunication on Progressatnovonordisk.com/annualreport. NOVO NORDISK ANNUAL REPORT2015 12 ACCOMPLISHMENTS AND RESULTS2015
ENVIRONMENTAL PERFORMANCE 0 1 2 3 4 2011 2012 2013 2014 2015 ENERGYCONSUMPTION • Realised Target (not toexceed)* *From 2007 to 2011, the target was set as an accumulated reduction over four years from a 2007 baseline. 1,000,000 GJ 2011 2012 2013 2014 2015 0 1 2 3 4 WATERCONSUMPTION • Realised Target (not toexceed)* *From 2007 to 2011, the target was set as an accumulated reduction over four years from a 2007 baseline. 1,000,000 m 3 NovoNordiskmeasures environmental per- formance on four dimensions:consumption of energy, consumption of water, CO 2 emis- sionsfromenergy consumption andwaste. ENERGYANDWATER In2015,2,778,000GJenergyand3,131,000 m 3 water were used at production sites around the world. In spite of a high focus on process optimisations, the energy consumption increased by9% andthewater consumption by 6%. This development reflects increased production and capacity. Ofthewaterused atproduction sites, 14% is in water-scarce regions in Brazil and China.Thesesiteshave aparticular focus on good waterstewardship. CO 2 EMISSIONS While the main focus of Novo Nordisk’s climate action programme has been to re- duce CO 2 emissions from production as well as emissions from distribution of products, NovoNordiskis now extending the scope of the climate programme to encompass indirect emissions from relevant business activities. The initial focus is on the supply chain, and emissions from company cars and business travel.Refertop 40 formore information ontheclimateambition. The CO 2 emissions related to consumption of energy at the production facilities de- creased by 11%, despite the increase in energy use of 9%. Theproduction plant in Tianjin, China, has started sourcing wind power from a windfarm in Inner Mongolia, and the Danish production facilities are now sourcing bio-natural gas.Thisisbiogas produced from liquid manure, food waste and organic waste from the industry. The biogas is upgraded to meet the quality re- quirements ofnatural gas and feeds intothe natural gas distributionsystem. CO 2 emissions from transport (product distribution)decreased significantly, by25%, compared with 2014.Thisismainly due to an increase in the volume of products distributed via sea from 72% in 2014 to 83% in 2015. In 2015, CO 2 emissions from seafreight accounted for16%,transportvia trucks accounted for 5% and air transport accounted for79%oftotalemissions.Distri- buting as many products as possible bysea isa priorityfor NovoNordisk,as itreduces bothCO 2 emissions andcosts. Novo Nordisk also aims to reduce CO 2 emissionsfrombusinessflights andcompany cars. In 2015, business flights resulted in estimated CO 2 emissions of 74,000 tons, which isan increase of 9% compared with 2014. The estimated CO 2 emissions from leased company carsdecreased by7%,from 72,000 tonsin2014to67,000tonsin2015. WASTE In 2015, Novo Nordisk generated 34,715 tons of waste, which isan increase of 13% compared with 2014.Thisismainly due to an increase in non-recyclable ethanol used in purification processes for insulin production. Reducing ethanol waste is a high priorityforthe company, and efficient regeneration plants enable the ethanol to bere-usedmanytimes. LONG-TERM ENVIRONMENTALTARGETS The long-term ambition is to decouple consumption of water and energy from sales growth.Thecurrenttarget issetas a maximum of half of the percentage in- creaseinsales inlocal currencies, measured as a three-year average. In 2015, sales increased by 8% in local currencies while energy consumption increased by 9% and water consumption by 6%. The target is challenged by production expansion and lowersalesgrowthrates. NEW LONG-TERM TARGET FOR CO 2 EMISSIONS NovoNordiskhassetanewlong-termtarget toreduce CO 2 emissions.Akeyelement of the strategy is increasing the share of renewable energy. In 2020, production sites worldwide will be 100% powered by renewable electricity. As part of the We Mean Business Coalition, NovoNordisk has signed the RE100 initiative led by The Climate Group in partnership with CDP. Thisisa collaborative initiative of influential businesses committed to 100% renewable electricity that is working to increase cor- poratedemand forrenewable energy. Foradditional information onenvironmental performance, see the environmental state- ment on pp 102–104 and the UNGCCom- munication on Progress at novonordisk. com/annualreport. NOVO NORDISK ANNUAL REPORT2015 ACCOMPLISHMENTS AND RESULTS 2015 13
2011 2012 2013 2014 2015 2014– 2015 FINANCIALPERFORMANCE Netsales 66,346 78,026 83,572 88,806 107,927 Change 22% NNIT Excl A/S 2 Underlying sales growth in local currencies 1 Currency effect (local currencyimpact) 11.4% (2.2%) 11.6% 6.0% 11.9% (4.8%) 8.3% (2.0%) 8.4% 13.1% Net sales growth asreported 9.2% 17.6% 7.1% 6.3% 21.5% Depreciation, amortisation and impairmentlosses 2,737 2,693 2,799 3,435 2,959 (14%) Operatingprofit 22,374 29,474 31,493 34,492 49,444 43% 36% Netfinancials (449) (1,663) 1,046 (396) (5,961) N/A Profit before income taxes 21,925 27,811 32,539 34,096 43,483 28% 21% Net profit for theyear 17,097 21,432 25,184 26,481 34,860 32% 22% Totalassets 64,698 65,669 70,337 77,062 91,799 19% Equity 37,448 40,632 42,569 40,294 46,969 17% Capital expenditure,net 3,003 3,319 3,207 3,986 5,209 31% Free cashflow 1 18,112 18,645 22,358 27,396 34,222 25% 17% FINANCIALRATIOS Percentage ofsales: Sales outsideDenmark 99.3% 99.4% 99.4% 99.5% 99.7% Sales and distributioncosts 28.6% 27.6% 28.0% 26.2% 26.2% Research and developmentcosts 14.5% 14.0% 14.0% 15.5% 12.6% Administrativecosts 4.9% 4.2% 4.2% 4.0% 3.6% Grossmargin 1 81.0% 82.7% 83.1% 83.6% 85.0% Net profitmargin 1 25.8% 27.5% 30.1% 29.8% 32.3% Effective taxrate 1 22.0% 22.9% 22.6% 22.3% 19.8% Equityratio 1 57.9% 61.9% 60.5% 52.3% 51.2% Return onequity 1 46.0% 54.9% 60.5% 63.9% 79.9% Cash toearnings 1 105.9% 87.0% 88.8% 103.5% 98.2% Payoutratio 1 45.3% 45.3% 47.1% 48.7% 46.6% Payout ratio adjusted for the partialdivestment of NNITA/S 4 45.3% 45.3% 47.1% 48.7% 50.0% LONG-TERM FINANCIALTARGETS 2015targets 3 Operating profitgrowth 18.4% 31.7% 6.9% 9.5% 43.3% 15% Operating profit growth in localcurrencies 22.1% 20.2% 14.6% 12.7% 20.6% Operatingmargin 1 33.7% 37.8% 37.7% 38.8% 45.8% 40% Operating profit after tax to net operatingassets 1 77.9% 99.0% 97.2% 101.0% 148.7% 125% Cash to earnings (three-yearaverage) 112.8% 103.7% 93.9% 93.1% 96.8% 90% 1.Fordefinitions,pleaserefertop94.2.Adjustedfornon-recurringincomefromthepartialdivestmentofNNITA/SofDKK2,376millionandnon-recurringproceedsinfreecashflowof DKK2,303million.3.Thelong-termfinancialtargetswereupdatedinFebruary2016.Pleasereferto‘2016Outlook’onp8.4.ThenetprofitimpactfromthepartialdivestmentofNNIT A/SwasreturnedtoNovoNordisk’sshareholdersthroughaDKK2.5billionincreaseinthesharerepurchaseprogrammeannouncedinApril2015. 2011 2012 2013 2014 2015 0 5 10 15 20 25 BIOPHARMACEUTICALS SALES Otherbiopharmaceuticals Norditropin ® Haemophilia DKKbillion 2011 2012 2013 2014 2015 0 25 50 75 100 125 SALESBYGEOGRAPHIC REGION Japan &Korea RegionChina International Operations Europe NorthAmerica DKKbillion 2011 2012 2013 2014 2015 0 20 40 60 80 100 DKKbillion DIABETES ANDOBESITY CARESALES Other diabetes and obesitycare Victoza ® New-generation insulin Modern insulins (insulinanalogues) Humaninsulins NOVO NORDISK ANNUAL REPORT2015 14 ACCOMPLISHMENTS AND RESULTS2015 PERFORMANCEHIGHLIGHTS
2011 2012 2013 2014 2015 2014–2015 SOCIALPERFORMANCE Change Least developed countries where Novo Nordisksells insulin according to the differential pricingpolicy 36 35 35 32 23 (28%) Donations (DKKmillion) 5 81 84 83 84 97 15% New patent families (firstfilings) 80 65 77 93 77 (17%) Employees(total) 6 32,632 34,731 38,436 41,450 41,122 (1%) Employeeturnover 9.8% 9.1% 8.1% 9.0% 9.2% Gender in Management(men/women) 63%/37% 61%/39% 61%/39% 60%/40% 59%/41% Relevant employees trained in businessethics 99% 99% 97% 98% 98% Productrecalls 5 6 6 2 2 – Failedinspections 0 1 0 0 0 – Company reputation (scale 0–100) N/A N/A 82.9 7 80.8 82.4 LONG-TERM SOCIALTARGETS 2015targets Patients reached with Novo Nordiskdiabetes care products (estimate inmillion) 20.9 22.8 24.3 24.4 26.8 40 by2020 Working the Novo Nordisk Way (scale 1–5) 4.3 4.3 4.4 4.3 4.3 4.0 ENVIRONMENTALPERFORMANCE Change Energy consumption (1,000GJ) 2,187 2,433 2,572 2,556 2,778 9% Water consumption (1,000m 3 ) 2,136 2,475 2,685 2,959 3,131 6% CO 2 emissions from energy consumption (1,000tons) 94 122 125 120 107 (11%) Organic residues(tons) 71,685 99,209 110,228 110,095 124,049 13% Waste(tons) 18,695 19,213 20,387 30,720 34,715 13% LONG-TERM ENVIRONMENTALTARGETS 2015targets Energy consumption (vs prioryear) (2%) 11% 6% (1%) 9% Not to exceed4% 8 Water consumption (vs prior year) 4% 16% 8% 10% 6% Not to exceed4% 8 SHAREPERFORMANCE Change Basic earnings per share/ADR in DKK 1,9 6.05 7.82 9.40 10.10 13.56 34% Diluted earnings per share/ADR in DKK 1,9 6.00 7.77 9.35 10.07 13.52 34% Total number of shares (million), 31December 2,900 2,800 2,750 2,650 2,600 (2%) Treasury shares (million), 31December 122 87 103 57 52 (9%) Share capital (DKKmillion) 580 560 550 530 520 (2%) Net asset value per share in DKK 1,9 12.91 14.51 15.48 15.21 18.07 19% Dividend per share inDKK 9 2.80 3.60 4.50 5.00 6.40 10 28% Total dividend (DKKmillion) 7,742 9,715 11,866 12,905 16,230 10 26% Share repurchases (DKKmillion) 10,839 12,162 13,989 14,728 17,229 17% Closing share price(DKK) 9 132.00 183.30 198.80 260.30 399.90 54% 5.DonationstotheWorldDiabetesFoundationandtheNovoNordiskHaemophiliaFoundation,whichareworkingtoincreasehealthcarecapacityindevelopingcountries.6.2015data excludeemployeesinNNITA/S,whichwasdivestedin2015(approximately2,400employeesinNNITA/Sin2014;hadtheseemployeesbeenincluded,thegrowthwouldhavebeen5%). 7.Dataforpeoplewithdiabetesandemployeesarenotincludedduetolackofavailability.8.The4% equalshalfofthebusinessgrowthmeasuredastheincreaseinsalesinlocal currenciesasathree-yearaverage.Fordetailedtargetdefinition,pleaserefertop13.9.Shareperformance-relatedkeyfigureshavebeencalculatedreflectingatradingunitofDKK0.20. 10.Proposeddividendsfortheyear(notyetdeclared). 2011 2012 2013 2014 2015 0 10 20 30 40 50 EMPLOYEES (TOTAL) Japan &Korea RegionChina International Operations Europe NorthAmerica Thousand 2011 2012 2013 2014 2015 0 80 160 240 320 400 SALES ANDCO 2 EMISSIONS (2004 =INDEX 100) • Index sales inDKK • Index CO 2 emissions Index 2011 2012 2013 2014 2015 0 10 20 30 40 50 NET CASHDISTRIBUTION TOSHAREHOLDERS Dividends Sharerepurchases DKKbillion NOVO NORDISK ANNUAL REPORT2015 ACCOMPLISHMENTS AND RESULTS 2015 15
up overtheyearsand continues toleverage inallfourtherapeutic areas.Thefinal ingre- dient of the strategy is the values-based management system, the Novo Nordisk Way. All of which serves the purpose of driving change todefeat diabetes and other seriouschronicconditions.Readmoreabout theNovoNordiskWayonp18. Sinceitwas founded inDenmarkmorethan 90yearsago,NovoNordiskhasbeenchanging diabetes.Thisheritagehasgiventhecompany experienceand capabilitiesthatalsoenable it to help people defeat other seriouschronic conditions: haemophilia, growth disorders and obesity.Today,NovoNordiskisa leading company within diabetes, haemophilia and growth disorders, and is well on its way to building apresence within obesity. This sharp focus on a few selected thera- peutic areas isakeypart ofNovoNordisk’s corporate strategy. Another is the strong focus on the constant development of five corecapabilities that NovoNordiskhasbuilt 1. EXPAND LEADERSHIP INDIABETES Accordingtothe International DiabetesFed- eration, 415 million people worldwide are living with diabetes, and itispredicted that by2040 morethan10%oftheworld’sadult population –642 millionpeople worldwide –willhavediabetes. 1 Theglobal marketfordiabetes careproducts amounts to 353 billion Danish kroner, of which Novo Nordisk products account for approximately 27%. Themarket has grown byaround 10% annually inthelastdecade, andallindications arethatitwillcontinueto growasaresultoftheincreasing number of people with diabetes and the need for better treatments. Of this global market, insulin accounts for 56%, oral diabetes products (tablet-basedmedications) account for 37% and GLP-1 products account for 7%,measured invalue. Diabetes care is by far Novo Nordisk’s largest business area, accounting for 79% of the company’s total sales. In 2007, the company decided tofocus all its efforts in diabetes care on protein-based products, suchasinsulin and GLP-1.Asaresult, today Novo Nordisk is the leader in both seg- ments, with market shares of 40% and 75% respectively, measured invalue. NovoNordisk’sambition istofurtherexpand its leadership within the insulin and GLP-1 segments. Key to achieving this ambition arethe new generation of insulin products, Tresiba ® , Xultophy ® and Ryzodeg ® , and the once-daily GLP-1 analogue Victoza ® , all of which have been or will be launched in convenient injection devices, such as FlexTouch ® . Significant projects in the re- search and development pipeline include a new faster-acting formulation of insulin aspart, a once-weekly injectable GLP-1ana- logue semaglutide and a once-daily tablet versionofsemaglutide. The ingredients that make up Novo Nordisk’s corporate strategy are a sharp focus onfour therapeutic areas, five core capabilities and a clear purpose, all anchored in avalues-based management system. OURSTRATEGY THE FOUR STRATEGICPRIORITIES NOVO NORDISK’SSTRATEGY STRATEGIC FOCUSAREAS CORECAPABILITIES Novo NordiskWay Engineering, formulating, developing and delivering protein- based treatments Deep disease under- standing Efficient large-scale production ofproteins Planningand executing global launches of new products Buildingand maintaining a leading position inemerging markets inOBESITY Expand leadership inDIABETES Establish presence Pursue leadership inHAEMOPHILIA Expand leadership in GROWTH DISORDERS Driving change to defeat diabetes and other serious chronic conditions PURPOSE NOVO NORDISK ANNUAL REPORT2015 16 OURBUSINESS
Innovative biological medicines such as these are NovoNordisk’s key contribution to defeating diabetes. However, the company is well aware that its products only do part of the job:ittakes more than medicine to change diabetes. That is why NovoNordisk, with Changing Diabetes ® , is engaged in other activities aimed at cre- ating awareness of type 2 diabetes and promoting healthy lifestyles and societal changes that are needed to curb the alarming riseinnew cases ofthedisease.A recentexample isCitiesChanging Diabetes, a global initiative to tackle diabetes in the world’s big cities.Readmoreabout: Novo Nordisk’s pipeline of products in development, p20 GLP-1 products, p26 The challenge of fighting diabetes, p22 Cities Changing Diabetes, p30. 2. ESTABLISH A PRESENCE INOBESITY Obesityisknown tobeamajorriskfactorin developing serious diseases such as type 2 diabetes and, assuch,isanaturaltherapeutic area forNovoNordisktoenter.Obesityhas reached pandemic proportions, with more than 600 million adults having clinical obesity (defined as having a Body Mass Index of 30 or above). 2 However, currently there are few pharmaceutical treatment options available to treat obesity, and reimbursement for these medications is limited. The global pharmaceutical market for obesity products currently amounts to around 10billionkroner. In 2015, NovoNordiskentered the obesity market with Saxenda ® (liraglutide 3 mg), which waslaunched intheUSinApriland is now alsoavailable inDenmarkand Canada. NovoNordisk’sambition istobuild a long- term presence in the obesity market, and Saxenda ® isseen as the firstof severalsteps towards achieving this. Read more about NovoNordisk’sobesity strategy onp28. 3. PURSUELEADERSHIP IN HAEMOPHILIA Haemophilia is an inherited or acquired bleeding disorderthat prevents blood from clotting. An estimated 420,000 people worldwide arelivingwithsevereormoderate haemophilia. 3 The global haemophilia phar- maceutical markethas a value of around 75 billion kronerand has grown byaround 5% annually inrecentyears. 5 NovoNordiskenteredthehaemophilia market in1996withNovoSeven ® forthetreatmentof peoplewithhaemophiliawhoformantibodies against traditionaltreatments. The launch of NovoEight ® in 2014 was a significant milestone in the company’s ambition to move from this niche into the main haemophilia A market. In January 2016, Novo Nordisk filed for regulatory approval of long-acting factor IXin the EU for the treatment of haemophilia B. Fur- thermore, the company has a long-acting clotting factor in phase 3 development for haemophilia A. NovoNordisk’sambition is toachieve a leadership position within both haemophilia A and haemophilia B.Read moreabout NovoNordisk’sactivities within haemophilia onp32. 4. EXPAND LEADERSHIP IN GROWTHDISORDERS NovoNordiskhasbeenactiveinthetreatment of growth hormone deficiency for almost fourdecades.Theglobal marketforgrowth disorder treatments is estimated to be 16 billion kroner. Novo Nordisk’sgrowth hor- mone, Norditropin ® , is the global market leader,withamarketshareof35%measured by value. The company’s ambition is to expanditsleadershipinthegrowth hormone market.AkeyprojectinthisrespectisNovo Nordisk’slong-acting growth hormoneprod- uctwhichisinphase 3development. FIVE CORE CAPABILITIES Novo Nordisk’s core capabilities have been developed and refined over manyyears. ENGINEERING, FORMULATING, DEVELOPING AND DELIVERING PROTEIN -BASED TREATMENTS NovoNordisk’s researchers are among the world’s best within protein engineering, formulation technology, expression and de- livery,enabling thecompany tocontinuously improve the properties of therapeutic proteins such as insulin and GLP-1and the injection devices needed. Recently, Novo Nordisk has built new capabilities in for- mulating protein-basedproductsintotablets. DEEP DISEASE UNDERSTANDING Striving for decades to meet the medical needs of people with diabetes has given NovoNordiskadeepunderstanding ofwhat itisliketolivewith thiscondition.Together with strong relationships and collaborations with externalresearchersand clinicians, this understanding provides a solid foundation for the company’s research, development and marketing activities. EFFICIENT LARGE-SCALE PRODUCTION OF PROTEINS A high-quality, cost-effective global manu- facturing infrastructure is a prerequisitefor competing successfully in an increasingly competitive pharmaceutical market. Novo Nordiskis the world’s largest producer of insulinand has been developing itsexpertise in the production of protein-based pharma- ceuticals since1923. Read moreabout new investmentsinproductiononp38. PLANNING AND EXECUTING GLOBAL LAUNCHES OF NEWPRODUCTS Duetothehighandincreasingcostsassociated withdeveloping andlaunching newmedicines, most products are launched globally overa relativelyshortperiodtoensurea reasonable time before patent expiration. Through the global launch of Victoza ® , NovoNordiskhas refined this capability, which is now being usedforthelaunch ofnewproducts,suchas Tresiba ® andNovoEight ® . BUILDING AND MAINTAINING A LEADING POSITION INEMERGING MARKETS Many yearsofexperiencehave helped Novo Nordiskunderstand the needs of emerging marketsastheirhealthcare systemsdevelop. Thecompany’s strategy has always been to establish a local organisation early and to grow organically as the market develops. This has enabled Novo Nordisk to build a highly skilled sales force, long-term rela- tionships and asustainable marketpresence inemerging markets. ENGINEERING, FORMULATING, DEVELOPING AND DELIVERING PROTEIN-BASED TREATMENTS 1920 1990 2000 NordiskInsulinlaboratorium (1923)and NovoTerapeutiskLaboratorium (1925) founded. 1940 Nordisk develops isophane insulin(NPH), aneutralinsulinwithprolonged action. 1980 NovoPen ® is launched –an injection system similar in appearance to a fountain pen. Novo starts production of human insulin with the help of genetically engineered yeastcells. Nordisk markets Norditropin ® –genetically engineered human growth hormone. NovoSeven ® is launched –for the treatment of haemophilia patients with inhibitorreaction. NovoRapid ® –the company’s first modern insulin –ismarketed. Victoza ® –a human GLP-1 analogue for once-daily treatment of type 2 diabetes –islaunched. 2010 Tresiba ® –the company’s first new- generation insulin –islaunched. NOVO NORDISK ANNUAL REPORT2015 OUR BUSINESS 17
NOVO NORDISK WAY Through its approach to business, Novo Nordisk aims to create shared value with itsstakeholders. NovoNordisk’svalues-based management system, theNovoNordisk Way, is a key ingredient in the company’s corporate strategy. “It describes who we are, where we want to go and the values that characterise our company,” explains President and Chief Executive Officer(CEO)LarsRebien Sørensen. Heargues thatitisan effective means of governing a fast-growing global organi- sation suchasNovoNordisk:“There’sno way we could have a written rule for everything we do in this company. In manycaseswehavetorelyonourpeople making the right decisions, and this is why the Novo Nordisk Way is so im- portant. Itapplies toand sets the direc- tion forallemployees atNovoNordisk– no matter what they do orwhere they work. It’s a promise we make to each otherand toourexternalstakeholders.” LarsRebien Sørensen mentions some of the ways the company ensures that the Novo Nordisk Way becomes part of every employee, from traditional means suchasemployee induction programmes and leadership training to a unique feature called ‘facilitations’ . A group of senior employees have been appointed facilitators and they travel the global organisation to interview employees, managers and internal stakeholders of the organisational units they are facil- itating, while also looking into docu- ments and local business practices. Ultimately, this forms the basis for an assessment of the degree towhich each particular unitisoperating inaccordance with theNovoNordiskWay. In1923,ourDanish founders began a journey tochange diabetes. Today, we are thousands of employees across theworldwiththepassion, theskillsand thecommitment to continue this journey toprevent, treat and ultimately curediabetes. • Our ambition is to strengthen our leadership indiabetes. • We aspire to change possibilities in haemophilia and other seriouschronicconditionswherewecanmakeadifference. • Ourkeycontribution istodiscoverand develop innovative biological medicines and make them accessible topatients throughout theworld. • Growing our business and delivering competitive financial results is what allows us to help patients live better lives, offer an attractive return to our shareholders and contribute to ourcommunities. • We never compromise on quality and business ethics. • Our business philosophy is one of balancing financial, social and environmental considerations –we call it the Triple BottomLine. • We are open and honest, ambitious and accountable, and treat everyone withrespect. • We offer opportunities for our people to realise their potential. Everyday wemust make difficult choices, always keeping inmind what isbest forpatients, ouremployees and our shareholders inthelongrun. It’s the Novo NordiskWay. NOVO NORDISK ANNUAL REPORT2015 18 OURBUSINESS
AssociationattheAnnualGeneralMeeting in2004.Itstates that Novo Nordisk”strives to conduct its activities in a financially, environmentally andsociallyresponsibleway”. The TripleBottom Line business principle frames Novo Nordisk’slong-term strategy tobe a sustainable business. Itobliges everyoneinthecompany toalways considerhow decisionsand actions mayaffect people, communities and the environment. Theaim is to ensure long-term profit- ability by reducing risksrelated tobusiness activities and to enhance the positive contributions to societyfrom Novo Nordisk’s global operations. LarsRebienSørensenunderlines thattheTriple Bottom Line principle is about maximising the value of the company in the long term. “Because,” as he said ina recentinterviewwithHarvard BusinessReview,“inthe long term, social and environmental issues become financial issues. There’s really no hocus pocus about this. And Novo Nordisk is part-owned by a Danish foundation that obliges us to maximise the value of the company for the longterm. “When weconverttorenewable energy, wereduce costs.Whenweprovideasafe workplace and chal- lenges for each individual, employees can realise theirpotential.Whenweprovideaffordable medicines intheworld’s poorest countries, we strengthen ourbusiness and reputation.And when wecontribute toourcommunities, weearnstakeholder trust,” headds. CREATING SHARED VALUE LarsRebienSørensen isafirmbelieverthatNovoNordisk’slong-term success depends on itsability tocreate both economic and societal development: “If we’re not seen as creating value for the local communities inwhich wehaveapresenceand thecountriesinwhich wedobusiness, wewillnotbesuccessful inthelong run.” Contributions to communities are often measured in economic terms, such as job creation and tax payments. NovoNordiskpays taxesinalljurisdictions wherethecompany ispresent.Ithasapolicy to‘pursue a competitive taxlevel ina responsible way’, reflecting a continued focus on value creation without compromising business ethics.Tomanage uncertainties regarding taxpayments, multi-year agreements, known asAdvance Pricing Agreements, arenegotiated inkeyjurisdictions and fully disclosed totaxauthorities. But there are more ways to generate value beyond commercial transactions.Often referredtoas creating shared value, companies can earnreturnsinasustainable waybydeveloping solutionsforthe benefit of society.Oneexample isin Kalundborg, Denmark, where NovoNordisk’slargest production siteislocated.Here,thecompany works with local stakeholders topromote sustainable development inthemunicipality.Itsaim istoensurethat Kalundborg willdevelop into an even more attractive place to live and work, and a place wherebusinesses willflourish. NovoNordisk’s initiatives at country level aim to create value for society on a larger scale, forexample bybuilding capabilities in the healthcare system and improving access to healthcare. When successful, this strengthens the company’s stakeholder relations, reputation and ultimately its chances of business success in that country. An example of this philosophy in action can be seen in Algeria, one of NovoNordisk’s fastest-growing markets, where the com- pany has had a successful partnership with the Ministry of Health formany years.Outcomes fromthispartnership include aChanging Diabetes ® mobile clinic, which improves the competences of local healthcare professionals, and access to diabetes screening and care for underserved populations, and the Algerian Changing Diabetes ® Barometer, which measures progress in the fight against diabetes. DRIVING CHANGE ONAGLOBAL SCALE Novo Nordisk proactively engages in dialogue on sustainable development with relevant partners worldwide. Since the Rio+20 Conference in 2012, the company has participated in the process leading up to the approval of the United Nations Sustainable Development Goals (SDGs),or, as they are often referred to, the GlobalGoalsforSustainable Development. “TheGlobalGoalsareimportant forNovoNordisk,notleastbecause non-communicable diseases including diabetes are explicitly mentioned inthegoal toprovide‘health and well-being forall,ofall ages’,” says Lars Rebien Sørensen. “The Global Goals give us a platform fromwhich wecan engage local, national and international stakeholders indiscussions ondiabetes andsustainable development, but alsoonmany othertopicsonouragenda.” The end product is a report evaluating the unit’s performance against theNovoNordiskWayand an action plan agreed with local management forhow todo even better.Just as the facilitators can identify areas for improvement, they also identify best practices which can be shared throughout the company. Both Executive Management and theBoardofDirectorsregularly receivereportson how welltheorganisation isliving up totheNovoNordiskWay. THE TRIPLE BOTTOM LINE A key element of the Novo Nordisk Way is the Triple Bottom Line businessprinciple, which waswrittenintothecompany’s Articlesof NOVO NORDISK ANNUAL REPORT2015 OUR BUSINESS 19
Filed/ regulatory Phase 3 approval Diabetes Xultophy ® NN9068 Type 2 diabetes A combination of insulin degludec and liraglutide in a once- daily single injection. Approved inEurope. Faster-acting insulin aspart NN1218 Type 1 and 2 diabetes A new formulation of insulin aspart intended to accelerate onset of action, with the potential for increased flexibility of dosing. Semaglutide NN9535 Type 2 diabetes A once-weekly GLP-1 analogue intended to offer the clinical benefits of a GLP-1 analogue with less frequent injections to people with type2diabetes. OG217SC NN9924 Type 2 diabetes A long-acting oral GLP-1 analogue intended as a once-daily tablet treatment for people with type 2diabetes. OI338GT NN1953 Type 1 and 2 diabetes A long-acting basal insulin analogue intended to offer the clinical benefits of a basal insulin analogue in a once-daily tablet. Anti-IL-21T1D NN9828 Type 1 diabetes Intended as a beta-cell preservation treatment for people who are newly diagnosed with type 1diabetes. Dual-agonist NN9709 Type 2 diabetes A GLP-1/GIP dual-agonist intended as a once-daily treatment for people with type 2diabetes. LAI287 NN1436 Type 1 and 2 diabetes A long-acting basal insulin analogue intended for once-weekly dosing. Mealtime NN1406 Type 1 and 2 diabetes A liver-preferential mealtime insulin analogue. OI320GT NN1957 Type 2 diabetes Along-acting basal insulin inanoralformulation intended asa once-daily tablet treatment. PYY1562 NN9748 Type 2 diabetes An appetite-regulating hormone, peptide tyrosine, for the treatment ofdiabetes. PIPELINEOVERVIEW Studies in large groups of patients (usually 1,000–3,000) comparing a new medication with a commonly used drug or placebo for both safety and efficacy.Phase 3a coverstrialsconducted after efficacy isdemonstrated and prior to regulatory submission. Phase 3b covers clinical trials completed during and after regulatory submission. In small therapeutic areas such as haemophilia, regulatory guidelines may allow the design of single-arm therapeutic confirmatory trials or trials that compare against historical control,forexample, instead ofexisting treatment orplacebo. Phase3 Phase1 Studiesinasmallgroup (usually10–100)ofhealthy volunteers,and sometimes patients, toinvestigate how thebodyhandles, distributes and eliminates new medication and establish themaximum tolerateddose. Phase2 Studies ofvariousdose levelsina largergroup ofpatients (usually100–1,000) tolearnaboutthenewmedication’s effect ontheconditionanditssideeffects. In phase 2, clinical trials are carried out to evaluate efficacy (and safety) in specified populations ofpatients.Theoutcomeofphase 2trialsisclinicalproof ofconceptand theselectionofdoseforevaluation inphase 3trials. DIABETES AND OBESITYCARE Compound Indication Description Phase 1 Phase2 The phase in which a product undergoes regulatory authority review. Products listed under this phase are currentlyunder regulatory review in at least oneofthetriadmarkets:theUS,theEUandJapan. Filed/regulatory approval NOVO NORDISK ANNUAL REPORT2015 20 OURBUSINESS
Compound Indication Description Phase 1 Phase2 Filed/ regulatory Phase 3 approval Obesity Semaglutide NN9536 Obesity A long-acting GLP-1 analogue intended as a once-daily treat- ment forobesity. AM833 NN9838 Obesity A novel amylin analogue intended as a once-weekly treatment forobesity. G530L NN9030 Obesity A novel glucagon analogue which, in combination with lira- glutide, is intended for the treatment ofobesity. PYY1562 NN9747 Obesity An appetite-regulating hormone, peptide tyrosine, which, alone orin combination with semaglutide, isintended forthe treatment ofobesity. Haemophilia Aglycopegylated long-acting recombinant coagulation factorIX intended to offer prophylaxis and treatment ofbleeds. N9-GP Haemophilia B NN7999 N8-GP Haemophilia A NN7088 A glycopegylated long-acting recombinant coagulation factor VIII intended to offer prophylaxis and treatment ofbleeds. Concizumab NN7415 Haemophilia A andB Amonoclonal antibody against TissueFactorPathway Inhibitor (TFPI)intended for bleeding prevention after subcutaneous administration. Growth disorders Somapacitan NN8640 Growth disorders A long-acting human growth hormone intended to offer once- weeklyinjections. BIOPHARMACEUTICALS 2016 KEYMILESTONES Tresiba ® SWITCH and DEVOTEresults Victoza ® LEADERresults Semaglutide Phase 3acompletion Oralsemaglutide Phase 3ainitiation Xultophy ® Expected feedback from regulatory filing in theUS Faster-acting insulin aspart Expected feedback from regulatory filing in theUS N9-GP Regulatory filing in theUS Read more at novonordisk.com/investors and clinicaltrials.gov. NOVO NORDISK ANNUAL REPORT2015 OUR BUSINESS 21
The International Diabetes Federation (IDF) estimates that, of the 415 million people in the world living with diabetes, almost half have not been diagnosed. 1 Thismeans that approximately 193 million people are going about their everyday lives not realising the damage that isbeing done totheirbodies: thelonger ittakestodiagnose diabetes, the morelikelyitisthat complications will have arisen – including damage to the eyes, kidneys, nerves and heart. Furthermore, people with undiagnosed diabetes are at significantly higher riskofstrokeand cardio- vasculardisease. Alarmingly, the UK Prospective Diabetes Study (UKPDS) found that complications werealreadypresentinupto50%ofpeople at the time of diabetes diagnosis. 6 With almost 642 million people estimated to be living withdiabetes by2040 1 ,thenumber of people who remain undiagnosed isa major cause forconcern. “Traditionally,people only go tothe doctor when they have a problem – which means that by the time they’re diagnosed with diabetes a lot of damage has already been done, as someone can have diabetes for a long time before they experience any symptoms from complications,” explains Professor Stephen Gough, senior principal clinical scientistat NovoNordiskand former head ofdepartment attheOxfordCentrefor Diabetes Endocrinology & Metabolism (OCDEM).“If wearetoreducetheburdenof diabetes, wemust diagnose people earlier– timing iscrucial.” RISK-BASEDSCREENING Thediabetes ’Rule of Halves’ illustratesthat onlyhalf ofthemany millionsofpeople with diabetes have been diagnosed (seegraphic). The first – and perhaps the most crucial – step to breaking this rule is therefore to ensure that people with diabetes are diag- nosedearlier. President of the IDF, Dr Shaukat Sadikot, stresses how important it is that diagnosis ratesareincreased:“Widerscreening would enable ustocatchdiabetesatanearlierstage of progression when it’s easier to manage andtreatwellwithlessintensivetherapy.But unfortunately the reality is that universal screening isnot possible, because of popu- lationsizesand thecostsinvolved.” However,therearea number ofwell-known riskfactorsassociated withdeveloping type2 diabetes (seebox),and screening onlythose people who have one ormoreof these risk factorswould, inmany countries, bea man- ageable task. “Screening people who areathigher riskof having diabetes, before they exhibit any symptoms, would have a major impact on 193 MILLION PEOPLE DO NOT KNOW THEY HAVEDIABETES ARE YOU ONE OF THEM? Early diagnosis and optimal control ofblood sugar are key to avoiding long-term complications fromdiabetes.
Diabetes 100% Of the estimated 415millionpeople withdiabetes… Diagnosed 50% about 50% are diagnosed*… Receive care 25% of whomabout 50% receive care*… Achieve treatment targets 12.5% of whomabout 50% achieve treatment targets**… Achieve desired outcomes ˜6% of whom about6% live a life free from diabetes-related complications. *Actualratesofdiagnosis, treatment, targetsand outcomesvaryindifferent countries.** Thatis,recommended glucose levels. ACCORDINGTOTHERULEOFHALVES 7 , ONLYAROUND 6% OFPEOPLEWITHDIABETESLIVEA LIFEFREEFROM DIABETES-RELATEDCOMPLICATIONS.* THE ‘RULE OFHALVES’ health outcomes,” points out Dr Sadikot. “Notonlywould webeable tocatchpeople at an early stage of diabetes who would respond well to routine management, we would also be able tohelp people who are borderlinefordiabetes –who have impaired glucose tolerance, for example – and help them todelay theonsetofdiabetes through lifestylechanges.” With Changing Diabetes ® (see box), Novo Nordisk is promoting earlier diagnosis of diabetes through risk-based screening pro- grammes, sothat the riskof diabetes com- plications is reduced and people with dia- betes areable tolivetheirliveswith as few limitations aspossible. OPTIMAL CARE However, even when diagnosed with diabetes, the Rule of Halves highlights that onlyabout 12.5% of people receivethe ap- propriatetherapy toachieve theirtreatment targets. This means that very few can live theirlivesfreefromcomplications. ProfessorStephen Gough explains that the problem is that people with diabetes are often prescribedthesimplesttreatment, ora treatment that is not intensive enough to enable the optimal target tobe reached for thediseasestage.“Thenextstepintreatment isthen not taken until blood glucose levels increasetoanunacceptable level,”hesays. “In an ideal world, optimal control of diabetes is keeping blood glucose, lipid profiles and blood pressure the same as in someone without diabetes. This requires that treatment is initiated earlier and op- timised continuously. Many people, how- ever, may stop taking their medicine, because such tight control can lead to an increase in hypoglycaemic attacks and weight gain,” he continues. “This iswhere the new advanced and better-tolerated treatments come in. They have been de- signed to minimise some of the unwanted effects of optimal controland aretherefore easier for people to use to reach and maintain theirtargets.” THEBURDEN OFDIABETES Thediabetes pandemic isasevereburdenon people and society. According to the IDF, diabetes wasafactorin5milliondeaths and accounted for673billionUSdollarsinhealth expenditure,or11.6%ofthetotalhealthcare spend worldwide, in 2015. 1 Added tothis is the impact of reduced employment and productivity,which togetherputasignificant economic burden on people living with diabetes, theirfamilies and society.Evidence shows that early detection, even before symptomsareevident,andoptimalcontrolof diabetes lead to fewer and less serious complications, and increasedlifeexpectancy. Studies supporting the cost-effectiveness of screening and optimising treatment have proven that, while short-term costs of treatment and management may increase, long-term costs for healthcare systems will substantially decrease. 9,10,11 Furthermore, evi- dence suggests that, in the long term, the society gain will be three times the initial investment costs of optimising treatment. 12 Enhanced treatment is therefore not only cost-effective; it may also be cost-saving – and, ultimately,life-saving. HEART ATTACK Heartattack isthreetimes as likely and heart disease isup tofourtimesaslikely KIDNEY FAILURE Total kidneyfailure is three times aslikely AMPUTATION Diabetes is a leading cause of non-traumatic lower-limbamputations BLINDNESS Diabetes is aleading cause ofblindness POTENTIAL COMPLICATIONS OF UNCONTROLLED DIABETES STROKE Strokes are up to four times aslikely CHANGING DIABETES ® ® Changing Diabetes is Novo Nordisk’s response to the global diabetes chal- lenge. Thecompany’s keycontribution is to discover and develop better bio- logical medicines, but more is needed tohelppeople defeat diabetes –tolive alifewithasfewlimitationsaspossible. Changing Diabetes ® addresses the big- gestunmet needsandfocusesonthree priorities: more people with diabetes mustbediagnosed earlier,morepeople with diabetes must achieve optimal control, and diabetes must be on the agenda ofthosemanaging cities,where two outof threepeople with diabetes livetoday.Readmoreonp30.Formore information, visit novonordisk.com/ about-novo-nordisk/changing - diabetes. RISK FACTORS FOR TYPE 2DIABETES 8 Risk factors for type 2diabetes include: • Family history ofdiabetes • Overweight • Unhealthydiet • Physicalinactivity • Increasing age • High bloodpressure • Ethnicity • Impaired glucosetolerance • History of gestational diabetes • Poor nutrition during pregnancy. 23
FUTURE DIABETES MEDICINES WHAT’S NEXT FROM NOVO NORDISK’SLABS?
Treatmentoptionsfordiabeteshavecomea longwaysinceinsulinwasfirstusedin1922, but the ultimate goal of conveniently achieving normal blood glucose levels – with,forexample,noriskofhypoglycaemia orweightgain–hasstillnotbeenreached. “The realityis that we’re not there yet – therearestillchallenges toovercomewith current diabetes therapy,” explains Peter Kurtzhals,seniorvicepresidentand head of Global Researchat NovoNordisk. “This is why we have hundreds of world-class scientists,basedinourcutting-edgeresearch facilities in Denmark, the US and China, doing what we do best: finding new and betterprotein-based therapeutics.Thisisa very exciting time as we have so many promisingleadsfornewinnovativediabetes medicines.” INSULIN:THEULTIMATETREATMENT Whileinsulinremainsthe ultimate therapy 13 formany peoplewithdiabetestoday,much more can be done to improve insulin treatmentwith regardtoboth efficacy and convenience–and who knows betterthan people with diabetes? Tanner Barton, an American student-athlete who has type 1 diabetes,waspartofaNovoNordiskpatient workshop in Seattle in 2015, where he shared his views and wishes with Novo Nordiskresearchers. “I think it’s incredibly beneficial for people with diabetes to be engaged with pharmaceutical companies, so that treatments address not just the physical burden, but also the psychosocial burden of this disease. I believe thereare manyexcitingmedicinesonthehorizon,but it’simportanttheyhoneinontheaccuracy oftreatmentsothattheanxietyofregulating bloodsugarlevelsiseliminated,” hesays.“I wanttobeabletocompeteinaswimmeet andnotworryaboutmybloodsugar.” Within the field of insulin therapy, Novo Nordiskisdeveloping a faster-acting insulin and once-weekly long-acting insulins, with the aim of meeting the needs of people livingwithdiabetes. Although a once-weeklyinjectionofinsulin willappeal tomany people with diabetes, some may still prefer to forego injections entirely–whichiswhyNovoNordiskstarted working on the development of insulin in tablet forma few yearsago.Butthisisno easytask,asPeterKurtzhalsexplains:“Oral insulin,aswecallit,isa huge challenge, as wehavetofigure outa waytoprotectthe insulinmolecule sothat itisn’tdigested in thegut,thenfindawayforthislargeprotein molecule topass intothe blood streamin thecorrectquantitiesandforittoremainin thebloodfortherightamount oftime.But we have high aspirations and are excited about having brought an oralinsulincom- poundintophase2development.” Tofurther its knowledge and expertisein the field of proteindeliverydevices, Novo Nordiskrecently announced a three-year research collaboration with the Langer Laboratory at Massachusetts Institute of Technology,whichPeterKurtzhalshasgreat hopesfor:“ProfessorRobertLangerandhis team have a phenomenal track recordof being innovative at the interface of bio- pharmaceuticals and technology. Theyare world-leading experts in creating new approaches for delivering peptides and proteinsacrosscomplexbarriersinthebody, such as the intestine. This collaboration highlightsourcommitmenttooraltreatment options, and we’realready researchingthe next generation of oralinsulin.” Thispart- nershipisyetanotherexampleofaresearch collaborationagreement witha high-profile academic institutionthat NovoNordiskhas recentlyenteredinto;otherexamplesinclude OxfordUniversityandtheKarolinskaInstitute in Stockholm, whereseveraljointpost-doc programmes are now in place. “Collabor- ationsbetween academia and industrywill be increasingly important to translatenew discoveriesinto medicines for people with diabetes,” saysPeterKurtzhals. THEPOTENTIAL OFGLP-1 NovoNordiskisalsocontinuing itsresearch intoGLP-1(glucagon-likepeptide-1),a class ofmedicinewhichhassubstantialinnovation potential (see p 26). The company has a once-weekly GLP-1 analogue semaglutide inphase3and willsoontakeitsonce-daily oralGLP-1intophase3development.More- over,itisresearchingnext-generationGLP-1 productsaswellasnewcombinationswith insulintoimprovetreatmentoutcomes. Tofurtherexpand the company’s portfolio of projects, Novo Nordisk recently an- nounced itsacquisition of a researchport- foliofromtwobiotechcompanies based in the US. “These companies are a great addition toourcompetences,particularlyin proteinchemistry,and willfurtherstrength- enourpipeline, notleastwithinGLP-1and insulinresearch,”PeterKurtzhalssays. FINDING ACURE Nomatter the advances in diabetes treat- ment options, the biggest wish forpeople withdiabetes isstillfora curetobefound. “Because I’m such a passionate type 1 diabetesadvocate, I’veparticipatedinsome amazing outreach opportunities, but don’t get mewrong –Iabsolutelywant a cure!” emphasisesTannerBarton.“And Ithinkthe potentialforfinding a cureinmylifetimeis withinreach,ifthegreatmindsinthisworld cometogetherandworkasone.” NovoNordiskiscommittedtofinding acure, and thecompany iscontinuing itsstemcell researchin thisarea.“We’regetting closer thanevertothisgoal, butwedon’twantto raiseexpectations.It’san extremelydifficult task and we’reinvesting forthe verylong term,”stressesPeterKurtzhals. A powerful intervention, although not a cure per se, is also being investigated by NovoNordiskin the form of a compound thatmay conservebeta cellfunction –and therebypreventthe progressionof type 1 diabetes. “At Novo Nordisk, it’s our fundamental belief thatthefutureofdiabetes treatment is not simply ‘more of the same’ – it’s something new, innovative and exciting. Westand byouraspiration and belief that wecan continue doing betterthan what’s onoffernow.Witheachstep,we’regetting closertothesummitand tohelping people with diabetes live a life with as few limitations as possible,” Peter Kurtzhals concludes. Researchers at Novo Nordisk are working on newprotein- based medicines which hold great promise for diabetes treatment. “AtNovoNordisk,it’sourfundamental belief that the futureofdiabetes treatmentisnotsimply‘moreofthe same’ –it’ssomething new,innovativeandexciting.” PETER KURTZHALS HEAD OF GLOBALRESEARCH NOVO NORDISK ANNUAL REPORT2015 OUR BUSINESS 25
SMALL PROTEIN, BIGPOTENTIAL GLP-1 Glucagon-like peptide-1 (GLP-1) analogues are a relatively new therapy fordiabetes –but NovoNordiskhas been researching them for almost a quarter of a century. “GLP-1 is an extremely exciting peptide,” Executive Vice President and Chief Science Officer Mads Krogsgaard Thomsen explains. (Peptide is the scientific term for a smallprotein.)“We’veknown about itssignificant roleinmetabolism forsome time, but onlyrecentlyhave wecometounderstand some other roles it plays in the human body. This is opening up new avenues ofresearchforus.” Today,NovoNordiskisthe market leader in the GLP-1segment for thetreatment oftype2diabetes.Itscompound isliraglutide, aGLP-1 analogue marketed under thebrand name Victoza ® and deliveredas a daily injection. In 2015, the company launched a higher-dose version of liraglutide under the brand name Saxenda ® for the treatment of obesity. But what excitesMads Krogsgaard Thomsen most isthe pipeline of potential GLP-1analogue therapies that his people areworking onand which areaimed atdiabetes and obesity aswellasotherindications. APOWERFUL LITTLE PROTEIN LotteBjerreKnudsen, scientific vicepresidentwithin GlobalResearch, has been a driving forcein NovoNordisk’sGLP-1researchsince the company firstbecame interestedinthispeptide.“What makes GLP-1 sopowerful isthatitdoesseveralthings atthesametime–including lowering blood glucose levels with little riskof hypoglycaemia and reducingappetite, whichmayleadtoweight loss,”shesays. However, the hormone in its natural state is not a suitable drug candidate.“GLP-1hasahalf-lifeoflessthantwominutesintheblood andthereforecan’tbeusedasamedical therapyinitsnaturalform,so we needed to use our protein engineering expertise to create a modified version–an analogue –that willworkfor24hours.We’ve achieved this by attaching a natural fatty acid tothe GLP-1peptide that inhibits the elimination of GLP-1. The molecule was named liraglutide. Wefirst synthesised it in 1997 and were all veryproud when itenteredclinicaltrials,”explainsLotteBjerreKnudsen. PIONEERING THERAPY Liraglutide, which is 97% similar to the naturally occurring human GLP-1, went on to be launched in 2009 for people with type 2 diabetes and wasthefirstonce-dailyGLP-1treatment onthemarket. “I didn’t think of the potential market when we began working on GLP-1;Ijustknew thismolecule had a veryinteresting biology and I wasfocused ondoing whatwedobest,tomakeitauseful compound forpeople with diabetes,” LotteBjerreKnudsen says. Today, over 1 million people with type 2 diabetes globally use Victoza ® . And in 2015, Saxenda ® was launched in the US, Canada and Denmarkforthetreatment ofobesity.
HOW GLP-1WORKS Glucagon-likepeptide-1(GLP-1)isproduced bythegut and thebraininresponse toeating.GLP-1interactswith thepancreas toincrease theamount ofinsulin inthebody.Itstimulates insulin secretioninthebeta cellsinthe pancreas and reducesglucagon inthealpha cells.Itdoessoina glucose-dependent manner, which helpslower fasting and postprandial bloodglucose.Atthesame time,GLP-1increasesfeelings ofsatiety and reducesfeelings ofhunger –leading toareduction infood intake. EVEN GREATER POTENTIAL Inthe more than sixyears since Victoza ® entered the market, Novo Nordiskhas continued to study the GLP-1 molecule and has sub- sequently created semaglutide – another GLP-1 analogue that has shown great potential inphase 2and 3clinical trials. The company’s ever-growing expertise in protein engineering has enabled researcherstomodify the fatty acid attached tothe GLP-1 molecule, with the result that semaglutide remains in the blood plasma longer than liraglutide.Thismeans that semaglutide can be taken once a week compared with the once-daily administration of liraglutide. “I believe that once-weekly semaglutide has great potential as a treatment for type 2 diabetes,” says Mads Krogsgaard Thomsen. “The results from phase 2 as well as four phase 3a clinical trials underscore how powerful this molecule might be.” Semaglutide is currentlycompleting phase 3a trialsfortype 2 diabetes and under- going phase 2trialsforobesity. NEXT-GENERATION GLP-1 Thedevelopment ofsemaglutide hasalso,forthefirsttime,provided theopportunity forNovoNordisktodevelop a GLP-1analogue that can be taken as a tablet.“When we firstbegan working on GLP-1 analogues, people joked about creating a tablet version, as itwas deemed impossible,” explains Lotte BjerreKnudsen. “One of the problems isthat theuptake ofa proteinmolecule isgreatly reduced when it’staken orally–which isahuge problembecause you’llneed to administer a much larger amount, and there’ll be too big a variability inhow itworksfromday today inthe individual patient. Butbecause semaglutide isastable molecule, we’vebeen abletoget ittoworkinatablet.” Once-daily oral semaglutide for type 2 diabetes will enter phase 3 clinical development in February 2016. Mads Krogsgaard Thomsen says: “Our phase 2 data were really exciting,withoralsema- glutide efficacy data matching itsinjectable counterpart.Oralsemaglutide maythereforehavethepowerofGLP-1 combined with the convenience of atablet.” NEW AVENUE OFRESEARCH The potential of GLP-1 analogues for the treatment of conditions other than diabetes and obesity is also being investigated. Novo Nordiskplans to initiate a phase 2 clinical programme in 2016 to investigate semaglutide for the treatment of non-alcoholic steato- hepatitis (NASH). A common liver disease with no approved treatments currently, NASHmay progress tocirrhosis,hepatocellular carcinoma and liver failure. NASHis currently the third most common cause for liver transplantation and is projected to be the leading cause for liver transplantation in 2020. 14 “The liver handles both glucose and fat metabolism. GLP-1 therapy therefore appears to be an attractive approach totreating thistypeoffatty liverdisease because ofitsdual effect on blood glucose control and weight loss,” says Mads Krogsgaard Thomsen. “Today,weknowthatGLP-1playsakeyroleinmanyofthebiological processes in our body,” he adds. “I trulybelieve that we have so much more to understand, discover and develop in thisarea.” 27
Forthoseliving withobesity,stigmatisation is apainful realityofday-to-daylife.Itisanugly societal tropethat begins with the bullies in the school playground, and ends with an unsympathetic doctor refusing to prescribe anything otherthan“eatless,exercisemore”. Itisalsothemain hurdleNovoNordiskmust overcomeifthecompanyistomakeasuccess of Saxenda ® (liraglutide 3 mg), its first foray into the obesity pharmacotherapy space. Although theproductwas recentlylaunched in the US, where around 35% of the population has obesity, 15 it is by no means expectedtobecomeanovernightsuccess. “Yes, Saxenda ® has huge potential, but it’s certainly not going to be an instant block- buster,” explains Jakob Riis, executive vice president of China, Pacific & Marketing. “Oneday,hopefully, butthehorizonismuch longerthanitiswhen we’retaking aproduct intoanestablished marketwhereprescription habits arealreadythere. “Youhave torememberthatmany people – including some doctorsand healthcare pro- fessionals –simply don’t accept that obesity is a disease. Until we can convince them otherwise, we’ll struggle tomake Saxenda ® liveuptoitsfullpotential.” Thatiswhy NovoNordiskhas taken a very focused approach when bringing Saxenda ® to the market, as Jakob Riisexplains: “Our focusissolelyonpeople withaBMIof35or more, as they often need to lose weight quickly.” TEN-YEAR PLAN NovoNordiskhas a 10-year ambition that starts by educating doctors and payers about the scientifically proven benefits of Saxenda ® ,and culminates inNovo Nordisk OBESITYCARE BUILDING THE MARKET FROMSCRATCH How do you market a treatment for adisease that many doctors do not even acknowledge? That is the challenge facing Novo Nordisk following the launch of Saxenda ® , the company’s therapy for chronic weight management. Michael Battaglia lives in the USand works asacontractor. Michael’s BMI is35.
establishing a leading position within the treatment ofobesity. “Our first aim is to make sure obesity is widely recognised as a chronic disease and that evenamoderate weight lossof5–10% could have an impact on weight-related comorbidities,” Jakob Riisexplains. Novo Nordisk’s ambition is to develop a leading obesityportfolioand pipeline thatin 10 years’ time will include several phase 3 programmes – with at least one promising evengreaterweight lossefficacy. “These are fairly daunting tasks and, of course, we’ll have tofine-tune ourstrategy as we go along,” he admits.“However, we think thisambition –setout overa 10-year horizon –strikesthe right balance between being ambitious and beingachievable.” Itis a plan that has already been put into action in the US, where Saxenda ® was launched inApril2015.Thankstotheefforts ofNovoNordisk’sfieldsalesforce,whohave been on the road educating potential prescribers about the product’s safety and efficacy profile since day one, Saxenda ® is starting to reach those who need it the most. PATIENTS BEFORE PROFITS Although Saxenda ® may not be generating huge amounts of revenue forthe company justyet, Jakob Riisisclearthat –initially, at least – success will not be measured in dollarsandcents. “In the short term, we’ll be measuring success more in terms of the benefits it provides topatients –are they happy with the level of weight loss? We’ll also be seeking acknowledgement from both pre- scribersandpayersthatthisproductactually does what we say itdoes.” One man who knows all about patient needs is Joe Nadglowski, chief executive officeroftheObesityActionCoalition(OAC) – a 50,000 member-strong patient organi- sation dedicated togiving a voice tothose living with obesity across the US. Forhim, Novo Nordisk is already making a big difference –and heisproudtocallthecom- pany a partner in his organisation’s fight to help improve the lives of the 78.6 million adult Americans affected bythedisease. 15 “NovoNordiskislaying the groundwork to be seen as industry leader in the obesity space formany yearstocome,” hesays.“In theUS,patients arelooking fornewoptions totreatobesity, sotonow have weight-loss medications approved and available is a hugeboon forthoseliving with thedisease. “But moreimportantly, NovoNordiskrecog- nises the fact that not every therapy will work for every patient, and is therefore investing ina whole pipeline of future obe- sitytreatments.Couple this with a genuine desire to engage with and listen to the patient community, and it’s a recipe for lasting success.” THEBEGINNING OFTHEBEGINNING So what is next on the obesity agenda? According to Executive Vice President and Chief Science Officer Mads Krogsgaard Thomsen, Saxenda ® is just the beginning of anexcitingnew chapterforNovoNordisk. “WithSaxenda ® ,wecan help people under- standthatobesityisadiseaseoftenrequiring medical intervention and gradually build the market,” hesays.“My hope isthen thatour Seattleresearchsite,togetherwithourstrong academic network, will be able to pick up new targets and begin creating new biol- ogics which can make an even bigger dif- ferenceintermsofboth physical health and qualityoflifeforpeoplewithobesity.” Onemolecule already showing great poten- tialissemaglutide (seep26).Likeliraglutide, it is a long-acting glucagon-like peptide-1 (GLP-1)analogue, but recentphase 3 study resultssuggest it may be significantly more effective forthetreatmentofobesity. According to Mads Krogsgaard Thomsen, themostimpressiveresultsmayultimatelybe derivedfromcombination therapies–anarea he describes as ’the playground’ of Novo NordiskR&D. “Tenyearsdowntheroadwehavesomevery strong ambitions for new obesity medicines –specifically, combination therapies that work synergistically,” headds. Aglance atthepipeline gives a hintofwhat isinstore.Asidefromsemaglutide, thereare already three promising new candidates in development at NovoNordiskforthe treat- ment of obesity:NN9030,a novelglucagon analogue designed tobeusedincombination withliraglutide, NN9838,anovellong-acting amylin analogue, and NN9747,a novellong- acting PYY analogue (PYY is a human peptide, secretedinresponsetoa meal, that hasbeenshowntoreduceappetite). “Thisisonlythebeginning ofthebeginning,” Mads Krogsgaard Thomsen says.“With our obesity pipeline and strategy, we’re in a fantastic position to secure a leadership position within the field for many years to come, to the benefit of people who are struggling withobesity.” WHAT ISOBESITY? Obesityisdefined asabnormal orexcessivefat accumulation that may impairhealth forpeople with a body mass index (BMI)of morethan 30. BMI provides the most convenient population-level measure ofoverweight and obesity currentlyavailable. 2 BMI itself, however, does not define health risk.BMI isa simple weight-for-height index that is commonly used to classify overweight and obesity in adults. It is calculated bydividing a person’s weight inkilograms bythe square of the person’s height inmetres(kg/m 2 ). *OgdenCL,Carroll MD,KitBK &FlegalKM.PrevalenceofChildhoodandAdultObesityintheUnitedStates, 2011–2012. The Journal of the American Medical Association 2014; 311(8):806–814. OF THE US ADULT POPULATION (OVER THE AGE OF20) HAS OBESITY (BMI >30) * 29
What makes people in cities vulnerable to diabetes,andhow canwepreventpeoplefromgetting diabetesinthefirstplace? The inaugural Cities Changing Diabetes Summitsawthese questions and many more discussed, asover 250international delegatesdescendedonCopenhagen inNovember2015. TACKLING THE RISEOF DIABETES INCITIES Citiesarehome totwo-thirds oftheworld’s 415million people living with diabetes and, as the number of people with diabetes reaches 642 million, itisprojected that this proportion will risetothree in four people by 2040. 1 Whilstcities have the potential to bring about significant health benefits for residents, the vast human and economic burden of diabetes iscurrentlybeing driven bytheway people liveincities. In its second year of responding to this challenge, theCitiesChanging Diabetespart- nership has gathered momentum.Founding partners Novo Nordisk, University College London (UCL)and Steno Diabetes Center have been joined by five study cities – Copenhagen, Houston, Mexico City,Shang- hai and Tianjin.In 2016,Johannesburg and Vancouver will join the effort to identify, understand and address the rootcauses of diabetes incities. UNDERSTANDING THECHALLENGE The Cities Changing Diabetes programme has a three-phase strategy – to map the challenge, to share learnings with cities around theworldand toactasacatalyst for action todefeat theriseofdiabetes incities. The mapping phase provides a foundation for future interventions, as Jakob Riis, executive vice president at Novo Nordisk, explains:“Weknowthatcertain urban diets and lifestyles are driving diabetes, but we can’t hope toaddress these issues without first understanding what lies behind them. Inthesame waythatSherlockHolmesasked ‘why didn’t the dog bark?’, soourresearch needs to ask intelligent, new questions to bring about a deeper knowledge of this unprecedented challenge.” In 2015, the initial mapping phase resulted in the completion of the world’s largest study on urban diabetes, led by UCL in collaboration with leading researchers in the five study cities. Trained fieldworkers undertook more than 550 interviews with people at risk or already diagnosed with diabetes. This first-of-its-kind research found that vulnerability todiabetes incities around the world is influenced far more than previously thought by social and cultural factors. Multiple examples of these factors were found ineach study location and frequently came as a surprise to experienced re- searchers. In Mexico City, gender roles OF PEOPLE WITHDIABETES LIVE IN URBANAREAS 1
wereseen todirectly influence vulnerability todiabetes as women neglected theirown health toavoid being seen as burdensome. In Shanghai, the cultural trend for the denial of hardship meant that people with diabetes were less likely toseek help from friends, family or healthcare professionals. Such was thestrength ofsocial and cultural factors in Houston that the findings challenged the traditional notion of dis- advantage being equal to vulnerability, as segments ofsociety both with and without financial constraints had an increased risk ofdiabetes. Importantly for future research and inter- ventionstrategies, thefindings willbeuseful across the diabetes spectrum – from initial risk through to diagnosis and treatment. Furthermore, although the factors manifest themselves uniquely in different cities, they willhelp build a framework that willenable a consistent approach to understanding diabetes inothercitiesaround theworld. David Napier,professor of Medical Anthro- pology, UCL and global academic lead, believes that the research has moved traditional thinking about urban diabetes forward: “For the first time, we can con- fidently say that we have a holistic under- standing ofvulnerability todiabetes incities. Inparticular, ournew-found appreciation of the cultural and social drivers of the condition means that we can consider how and why past interventions may have fallen short, and consider new solutions fortradi- tional problems suchasdietandinactivity.” TRANSITION TOACTION The Cities Changing Diabetes Summit marked the first major milestone for the partnership and provided the first op- portunity forthepartners tocometogether to discuss the findings and share local learnings and experiences.Italsoprovideda forum for transition, as delegates from 27 countries turned their minds to the action phase of the programme. Tofacilitate this step, keynote speakers and workshops focused not only on diabetes but also on urban planning, collaborative working and peersupport. After opening the Summit, Frank Jensen, Mayor of Copenhagen, commented: “Through thispartnership, wehave –onthe one hand – been reaffirmed on why Copenhagen has succeeded in becoming such a liveable city.Butwe’ve also –onthe otherhand –realisedinwhichareasweneed to act in order to improve the health and well-being of our citizens. Having come together with colleagues from other cities, partners and expert contributors at this Summit, we’renowreadytoputinplacenew solutions that safeguard and improve the healthofourcitizensinCopenhagen.” Acrossthe five cities, the action phase has been gathering pace throughout 2015. Through town hall meetings, the partners have already engaged hundreds of stake- holders, including non-governmental organi- sations (NGOs),faith-based groups, employ- ers, health providers and beyond, to share local learnings and insights and to form actionplans.Inordertodrivetheprevention, early detection and improved treatment of diabetes, uponleavingtheSummit,delegates voted to focus action on areas including community-level interventions beyond the traditional scope of clinical care and the integration of health within urban planning and municipalpolicies. ForNovoNordisk’spart, afurther20million USdollars of expert resourceand research funds has been committed to the fight against urban diabetes by2020.Inaddition, a partnership withC40–theworld’slargest network of megacities –was announced in December 2015 to move health up the agenda of those managing and designing theworld’surbanenvironments. Looking ahead, Presidentand CEOof Novo NordiskLarsRebienSørensenreflected:“We remainconvincedthataddressing diabetes in the urban setting isthe right thing todo – both by our company and by the global community which we serve.We’recommit- tedtochanging diabetes, andpreventingthe riseofthisconditionthrough healthy citiesis fundamental to this objective.” Read more about the Cities Changing Diabetes part- nership,visitcitieschangingdiabetes .com. 16 31
Notsolong ago, theoutlookforapersonwhodeveloped antibodies (inhibitors)against standard haemophilia treatments was verybleak, but in June 1985, NovoNordiskbegan a groundbreaking project to develop recombinant factor VIIa – the active ingredient in NovoSeven ® .Aftermorethan adecade ofdevelopment, NovoSeven ® waslaunched, enabling thebloodofinhibitorpatients toformstable clots without the use of standard blood factor treatments. As NovoSeven ® isnotderivedfromhuman bloodplasma, thisinnovative product also addressed concerns at the time regarding safety in relationtobloodcontamination. Paul Huggins, who heads NovoNordisk’sglobal marketing of bio- pharmaceuticals inZurich,Switzerland, appreciates what abig –and risky–step the development of NovoSeven ® was for the company. “Thebusiness casewasnotconvincing asthepatient population was onlyafewthousand people globally.Butthecompany’s management decided nevertheless that itcouldn’t ignore theunmet medical need as NovoNordiskhad the capabilities to develop a compound that would potentially meetthisneed,” heexplains. NovoSeven ® went ontobecome a veryimportant treatment option, used for the on-demand treatment of bleeding episodes and the management ofbleeding during surgeryforpeople withhaemophilia with inhibitors, acquired haemophilia, factor VII deficiency and Glanzmann’s thrombasthenia. GIVING PEOPLE ACHOICE By the mid-2000s, Novo Nordisk started developing new and innovative factorVIII,IXand XIIItreatments forbleeding disorders. NOVO NORDISK HAEMOPHILIA FOUNDATION On25 January 2015,theNovoNordiskHaemophilia Foundation cele- bratedits10thanniversary.TheFoundationisagrant-makingnon-profit organisation that strivesto improve access to care for people with haemophilia and alliedbleeding disorders.Sinceitwasestablished, the Foundation has supported 168 programmes in 63 countriesin the developing world,wheremanypeoplewithbleeding disordersstilllack properdiagnosisoradequate care.Readmoreonnnhf.org. 30YEARS WHAT ISHAEMOPHILIA? Haemophilia isaninheritedoracquiredbleeding disorderthatprevents the blood from clotting. People with haemophilia either partially or completely lack an essential clotting factor needed to form stable blood clots. Without treatment, uncontrolled internal bleeding can cause stiffness, pain, severejointdamage and evendeath.Treatment withreplacementclotting factorsmaybeadministered when bleeding occursor,increasingly, ona preventivebasis(prophylactic treatment). People with haemophilia A, an estimated 350,000, 17 have absent, decreased ordefective production of the blood clotting factor VIII. People with haemophilia B, of whom therearesome 70,000, 18 have deficiencies inproducing clotting factorIX.Bothtypesareinherited. “In 2012,welaunched NovoThirteen ® ,which ismarketed asTretten ® in some countries, for a very small and vulnerable community of people with congenital factor XIIIdeficiency, which isan extremely rareand seriousbleeding disorderaffecting onlyabout 1,300people globally,” saysPaulHuggins.“Wethenhad twoproducts forpatient communities which hadn’t previously attracted a lot of attention from companies engaged in haemophilia –which made the launch of NovoEight ® last year very important to us, as it was our first treatment forthewiderhaemophilia community.” Atthe time of approval, NovoEight ® was the first new recombinant factor VIII treatment for people with haemophilia in Europe and Japan for overa decade. Itwas launched in Europe and Japan in 2014and intheUSin2015.“NovoEight ® hasbeenverywellreceived intheUS;theuptake has exceeded ourexpectations.Patients like –and deserve –a choice, which is why I think the haemophilia community has welcomed NovoEight ® ,” explains Paul Huggins. THREE DECADES OF RESEARCH AND DEVELOPMENT Thirtyyearson,andNovoNordisk’scommitmenttothehaemophilia community –whichbegan withNovoSeven ® –isundiminished. With its long-acting versions of factor IX (N9-GP) and VIII (N8-GP),whichNovoNordiskexpectstosubmitforregulatory approval in 2016 and 2018 respectively, the company aims to provide even more options for people with haemophilia. NovoNordisk alsohasalong-acting versionofarecombi- nant factor VIIa in pre-clinical development, which it hopes will make routine prophylaxis the norm for people with inhibitors. Moreover, the company is developing a monoclonal antibody against TissueFac- tor Pathway Inhibitor (TFPI), which is intended for prophylactic treatment after subcutaneous admin- istration (see R&D pipeline on p 21). OF CHANGING HAEMOPHILIA Building on its experience with NovoSeven ® , Novo Nordisk has in recent years expanded its presence in haemophilia with NovoThirteen ® and NovoEight ® , underscoring itscommitment to help defeat this seriouscondition. Carl lives with his mother, father and little sister in Lyngby, Denmark. Carl is 8 years old and in2nd grade and was diagnosed with haemophilia at birth.
Behind every great company are great people. In Novo Nordisk’s case that’s 40,000+ people who day in, day out, play their part in making the complex machinery of a globalorganisationworksmoothly–withcompetence,commitmentandapassionfor improvingthelivesofpeoplewithdiabetesandother seriouschronicconditions.Here areafewnumbersaboutthepeoplebehindNovoNordisk. PROGR EMPLOYEE DEVELOPMENT * MANAGEMENT APPOINTMENTS ** 1 , 373 27 IONS *** OVERALL RETENTION RATE **** 90.8% ENGAGEMENT SCORE ***** 4.3 11% 89% 26% 74% M Tea 39% 61% 56% MEN 51% WOMEN 49% MEN 44% WOMEN 0 10,00 20,00 30,00 40,00 ¦ Denmark OutsideDenmark 37.5% 62.5% 0 0 0 2015 0 2010 2011 2012 2013 2014 2015 ESS IN GENDER DIVERSITY INM anagers/ Corporate Vice mLeaders Presidents/ Vice Presidents/ General Managers 2015 2015 ANAGEMENT Executive Vice Presidents/ Senior Vice Presidents 2015 Women Men Total 2015 1 , 8 INTERNAL PROMOT 42% 30% 14% 41% 2015 58% 70% 86% 59% 2010 2010 2010 2010 * Development in the number of employees excl NNIT A/S. ** All appointments to management positions, incl internal promotions and external hires in 2015 excl NNIT A/S. *** Employees moving to a job at a higher level within a 12-month period excl NNIT A/S. **** Retention of employees excl NNIT A/S. ***** Working the Novo Nordisk Way (scale1–5). NOVO NORDISK ANNUAL REPORT2015 OUR BUSINESS 33
THE FUTURE OF PHARMACEUTICALS Most financial analysts and other observers of the pharmaceutical industry agree on one thing: the industry is changing.In fact, the way most healthcare products and services are being delivered and paid for is undergoing rapid change –nowhere more so than in the US, the world’s largest economy and healthcare market. This article takes a closer look at the changes in theglobal healthcare market and how they may affect NovoNordisk. THE PHARMACEUTICAL MARKET’S FOURHURDLES NNOOVVOONNOORRDDIISSKKAANNNNUUAALLRREEPPOORRTT22001155 34 OURBUSINESS
All overthe world, governments, healthcare professionals, patients, pharmaceutical companiesandahostofintermediariesareengaged in heated debates and tough negotiations about which patients should haveaccesstowhichproductsandservices,atwhatcostand,letusnot forget,whoshouldfootthebill. Somewillargue(andrightlyso)thatthisisnotanewdiscussion.Foras longastherehavebeenhealthcaresystems,therehavebeendiscussions abouthowtobalanceaccess,costandquality–thethreefoundational elements of a healthcare system.However,what many patients have experiencedinrecentyearsisthat costcontainment has become the dominant consideration when healthcare systems implement new initiatives or reforms. One consequence is that more patients are finding themselves denied access to pharmaceuticals and healthcare servicesthat they would previouslyhave expected tobe coveredby theirpublichealthcare systemorinsurance. Thepharmaceutical industryisfeeling theeffectsofthestrongfocuson costcontainmentintheformofever-tougherpricingandreimbursement negotiations, sometimesresultinginreimbursementbeing deniedbya publichealthcaresystemor,intheUS,exclusionfromtheformulariesof managed careorganisations. Whenintroducing newproducts,research-basedcompanies arefacing what has become known as the ‘fourth hurdle’ –being requiredby payerstodemonstratethattheirnewproducts,inaddition tobeing of good quality,effective and safe, alsorepresentgood valueformoney. Toclearthisfourthhurdle,companies needtoshowthattheirproducts aremoreeffective than relevantcomparatorsand that the increased costisoffset bysavings elsewhereinthehealthcare system.Whilethis may not sound likean unreasonable demand, it isoften difficult to meet.Onereasonisthat the benefits ofusing a newerproduct may onlybecome apparent yearslater–which, forsomeone charged with making endsmeetinthisyear’sbudget, isnotanattractiveproposition. Diabetesdrugs serveasa case inpoint:a new treatmentmay help a personwithdiabetesachievebettercontroloftheirbloodglucosethan an olderproduct.Intheshortterm,thismay give thepersonabetter quality oflife–which isimportant –but thebiggest costsavings are likelytocomemuch later,fromthereducedriskofdeveloping serious long-term complications from diabetes: blindness, amputations and nervedamage.IntheUS,forexample,ithasbeenestimatedthatofthe total healthcare spending on diagnosed diabetes, hospital inpatient careaccountfor43%,medicinestotreatcomplications18%,diabetes medicinesandsupplies12%andothercosts27%. REAL-WORLD EVIDENCE Novo Nordisk Executive Vice President Jakob Riis, whose respon- sibilitiesinclude ensuring market accessforthecompany’s products, mentions another complicating factor when pharmaceutical com- panies and payers negotiate the pricing and reimbursement of a product: “There’s no commonly agreed standard for evaluating whether a new treatment will lead toan improved health outcome forcertain patients and the financial value of this.Each healthcare systemseems todothisinitsownway.” One general trend, though, is that payers want more ‘real-world evidence’ ofthebenefits ofanew productinaddition tothedata on efficacy and safety fromtheclinicaltrialsthat formed thebasis ofits approval byhealth authorities.Payerswant toknow whether similar resultscan be achieved in reallife, when patients arenot part of a clinicaltrial. “We’llhave tofind ways tocollectand analyse real-worldevidencein awaythatsatisfiespayers.Thiswillbeafocusareaforourdevelopment andmarketaccessorganisations inthecoming years,”saysJakob Riis. In this context, he mentions the opportunities presented by an increasingly digitalised healthcare system and, as an example, highlights a partnership Novo Nordisk formed with IBM Watson HealthinDecember2015:“By combining ourleadership indiabetes care with the analytical power of IBM Watson Health’s cognitive computing capability, we’ll explore possibilities for improving diabetes care through the gathering and analysis of real-time, real- world evidence from current diabetes treatment. If successful, this willnotonlyhelpimprovethelivesofpeople withdiabetes bymaking Sales (USDbillion) CAGR % (2014–2020) 6.8% 7.4% 3.4% 7.6% 1.3% 4.2% 0 100 200 300 500 400 600 2014 2015 2016 2017 2018 2019 2020 Source: IMS Market Prognosis Global Sept 2015. At ex-manufacturer price levels, not including rebates anddiscounts. THE GLOBAL PHARMA MARKET IS FORECASTED TO GROW 6% ANNUALLY IN THE PERIOD 2014–2020: THIS BRINGS THE TOTAL MARKET TO USD 1.4 TRILLION IN2020. Global market sales (2014–2020) • US • Emerging markets • Europe • China • Japan •Others CONTINUED NOVO NORDISK ANNUAL REPORT2015 OUR BUSINESS 35
the management of the condition more simple, effective and measurable, but will also help satisfy the payers’ demand for real- worldevidence ofthebenefits ofourproducts.” THEIMPORTANCE OFINNOVATION Despite market access challenges and price pressure, the pharma- ceutical industry is still expected to grow. The need for more and better pharmaceuticals keeps growing with ageing populations and theincreasing prevalence ofchronicdiseases, suchastype2diabetes, that come with age, unhealthy eating habits and toolittle exercise. Atthesame time, economic growth insome countrieswillallow for morefunds tobeinvested inbetterhealthcare.Giventhislandscape, IMS Health, a leading global information provider,predicts that the pharmaceutical industry will grow global sales by 6% per year between now and2020. Notallcompanies willdoequally welland, forsome,theonlyoption istoletthemselves beacquired ormerged withanother company.In October2015,ThomsonReutersreportedthatmorethan 850 billion US dollars of merger and acquisition transactions had been an- nounced sincethestartof2014. “NovoNordiskhasnoplanstoengage insuchindustryconsolidation,” saysPresidentand CEOLarsRebienSørensen.“I appreciate that such movescan help boostprofitswhen salesareunderpressure,but only shortterm.Theonlywaytodrivevalueinthelongtermisbyinnovation. Aslongasourresearchand developmentorganisationcancontinueto discovernew treatments that are firstin a new class orsignificantly betterthan products in an existing class, we’ll be able togrow. We currentlyhaveaverystrongpipelineofproductsthatwe’llbelaunching inthecomingyears.Ourmainchallenge willbetomakethemaccessible toasmanypatientsaspossiblewhileobtaining apricethatreflectsthe clinical value the new products bring. That’sno easy task in today’s healthcareenvironment,butit’sonewe’redeterminedtocarryout.” The following is an overview of the world’s main pharmaceutical markets. UNITED STATES TheUSistheworld’slargest marketforpharmaceuticals, accounting forroughly 44% ofglobal sales.Productsuccess islargely based on competition onefficacy, safety, quality andprice. TheUShealthcare system iscomplex, as itinvolves multiple payers and intermediaries with complex interactions. Roughly half of all Americans are insured by their employers – this is known as the managed care segment. One-third is insured through public programmes, such as Medicare and Medicaid, while around 9% of Americans are uninsured. The number of people insured through public programmes isexpected togrow,while thenumber ofpeople uninsured isexpected todropinthecoming yearsdue, among other reasons, tothepublic exchanges thatwereestablished aspartofthe Affordable Care Act. To manage the purchase and delivery of healthcare, employers and the government contract with inter- mediaries such as health plans and pharmacy benefit managers (PBMs).Theseareoften referredtoaspayers, but areinmost cases managers ofhealthcare costsonbehalf ofpayers. Health plans contract with providerssuch as physician, hospital and pharmacy networks to provide the required service. They provide different levels of coverage based on the payers’ willingness topay forselected services fortheiremployees.APBM isan intermediary thatcontractswithpayersand health plans tomanage thepharmacy benefit fora specificpopulation. Thehealth plans usevariousmethods tomanage theuseand costof pharmaceuticals . Among the most widely used interventions are generic substitution, quantity limits, prior authorisation (which meansthatamedication willonlybecoveredundercertainconditions and subject to individual approval by the health plan) and tightly controlledPreferredDrugLists. FOCUS ISSHIFTING TOVALUE While,formany years, healthcare inthe USwas delivered bysmall, independent practices and hospitals, and paid for as a fee-for- service,moreand morehealthcare providersarenowbecoming part of fully integrated delivery networks. Moreover, new payment models are emerging, with a growing number of accountable care organisations being paid for delivering certain performance or outcome targets ratherthan afee-for-service. At the same time, the managed care segment is consolidating, leading tofewer, more powerful payers.Asa result, rebate nego- tiations have become tougher for the pharmaceutical industry. Contractsaregenerally ofshorterduration than before and often HEALTHCARE PROFESSIONALS ARE CONSOLIDATING INTO INTEGRATED DELIVERY NETWORKS IN THEUS Newmodel Fully integrated delivery networks paid for delivering certain performance or outcometargets Traditional model Independent practices and hospitals paid ona fee-for-servicebasis Patient management The pressures on healthcare professionals and market trends point in the same direction: towards organisation and corporatisation of primary care PRESSURE TO REDUCE COSTS MISALIGNED INCENTIVES HEALTH INFORMATION TECHNOLOGY FEDERAL & STATE HEALTH REFORM NEW MODELS OF CARE DELIVERY GROWING PATIENT EMPOWERMENT Population management NOVO NORDISK ANNUAL REPORT2015 36 OURBUSINESS
have price protection mechanisms built in, which means that list price increases automatically trigger an increased rebate level. Anothertrend ofnoteistheincreasing number ofpeople obtaining coverage through Medicare PartD.Therebates that pharmaceutical companies must offer forcontracts under thisscheme aregenerally higher than forprivatemarketcontracts.Nevertheless,theUS,which in2015 accounted for51%oftotalNovoNordisksales, iswherethe company expects to generate most of its growth in the coming years. The main growth drivers are expected to be market share gains in the insulin market, upgrades to new-generation insulin products and the continued penetration of GLP-1products for the treatment ofdiabetes andobesity. EUROPE Europehas been a market with no orverylimited growth formost pharmaceutical companiesforquitesomeyears.Thisispartlytheresult ofthedepressedeconomyinmanyEuropeancountriesinthewakeof the financial crisis,which has led governments to implement cost- cutting measures in many shapes and forms. Therearecurrentlyno signsthatthiswillchange significantly inthenearfuture.IMSpredicts low single-digit growth in the coming years, with almost all growth coming fromspecialitydrugs.NovoNordiskalsoexpectsverymodest growth in Europe due to the above-mentioned factors, increasing competitionanditshigh marketshareintheinsulinsegment. CHINA China is the world’s second largest healthcare market. Annual growth ratesof15–20%werethenormuntilrecently,astheChinese government invested heavily in expanding access to healthcare, especially in larger cities.Investments came in response togrowing demands from an ageing population increasingly prone todiabetes and other chronic diseases that often come with urban lifestyles. However, all signs are that double-digit growth rates are history. Withthe slowdown inChina’s economic growth in2014 and 2015, the government now has a stronger focus on cost containment. Increased use of essential drug lists and a new drug price review processservetoforcepricesdown.Moreover,specific measureshave been taken toreducehospitals’ reliance ondrug salesasasourceof income and limit pharmaceutical companies’ access to healthcare professionals. China is NovoNordisk’ssecond largest market. An estimated 110 millionChinesehavediabetes and lessthan aquarterofthemreceive medical care, so despite the factors mentioned above –as well as increasing competition from international and local competitors – NovoNordiskexpects continued growth inthe coming years, albeit notatthedouble-digit growth ratesseeninthepast. EMERGING MARKETS China is far from the only country facing the growing burden of chronicdiseases. Growing economies inAsia,theMiddle East,Africa and Latin America areexperiencing exactly the same phenomenon . IMS predicts that closeto50% ofpharmaceutical marketgrowth in 2015–2020 willcomefromthesecountriesaspopulations grow and age, and economic growth makes itpossible formorepeople toget some form of healthcare. At Novo Nordisk, these countries are grouped under International Operations –a vast and diverseregion ofmorethan 140countries. Nextto the US, the countries in International Operationsrepresent NovoNordisk’slargest growth opportunity inthecoming years.Half of all people with diabetes live in this region, and the number is growing fasterthan anywhere else.Inmany ofthecountries,thereis both a public and a privatemarket.Thepublic market typically only reimbursestheuseoflow-pricedhuman insulinvials,whiletheprivate market typically comprises modern insulin and Victoza ® paid for by people who eitherhave privateinsuranceorwho can payoutoftheir ownpocketsatpricessimilartothoseinmoredeveloped markets. JAPAN In Japan, the government will be implementing price revisions, which, together with the increased utilisation of generics, means that IMS predicts a flat market. Furthermore, the insulin market is declining duetotheincreased useofneworalantidiabetics, which is why NovoNordisk, despite success with Tresiba ® and Victoza ® and with the launch of Ryzodeg ® ,expects verymodest growth inJapan inthecomingyears. 2011 2012 2013 2014 2015 0 10 20 30 DIABETES CARE Value market share by geographic region • NorthAmerica • Europe • International Operations • RegionChina • Japan &Korea % 40 ”We currently have a very strong pipeline of products that we’ll be launching inthecomingyears.Ourmainchallenge willbeto makethem accessible to as many patients as possible while obtaining a price that reflects the clinical value the new productsbring.” LARS REBIENSØRENSEN PRESIDENT ANDCEO OUR BUSINESS 37
Novo Nordisk insulin production plant in Kalundborg, Denmark. Manufacturing proteins, such asinsulin, isa highly sophisticated task. While other pharmaceuticals are manufactured through a seriesof chemical syntheses, proteins are bigger, more complex molecules, and producing them relieson large investments in sterile production facilities and an understanding of working with living cells, such as yeast, to produce a pure, uniform product. “Novo Nordisk is the world’s largest pro- ducer of insulin and has developed its production expertise over almost nine decades,” says HenrikWulff, executive vice president and head of Product Supply. “We’ve been manufacturing insulin since the 1920s, and the efficient large-scale production of proteins is one of our core competences. “There have been many innovations over the yearsaswecontinuously strivetomake our production processes even more ef- ficient and stable,” he continues, “and our focus has stayed the same – on increasing ambitions: delivering high-quality products in regulatory compliance and meeting the increasing global demand forourproducts.” MEETING GLOBAL DEMAND The year 2015 was an exciting time for ProductSupply, asNovoNordiskannounced several plans for major investments in new production plants overthe next five years. This will also be evident from Novo Nordisk’s accounts in the coming years, according toNovoNordisk’s chief financial officer, Jesper Brandgaard. Commenting on investments at Novo Nordisk’s Capital Markets Day in November 2015, he said: “Demands to support future product supply are rising, and we expect investments relative tosales willincrease in theyearstocome.” The largest planned investment is a diabetes API (Active Pharmaceutical Ingre- dient) production site in Clayton, North Carolina, USA. The site is expected to be operational in 2020 and is estimated to create close to 700 new production and engineering jobs in Clayton, where Novo Nordisk already employs more than 700 people. A further 100 new jobs will be created at a new drug product plant in Måløv, Denmark. Novo Nordisk plans to invest 2 billion US dollars in these two facilities inthenextfive years. Among other major expansion projects announced in 2015 is a filling facility in Hillerød, Denmark, which will produce medicines forthetreatment ofdiabetes and obesity.This10,300 m 2 production facility is expected tobe operational in2019 and will add 450 new production and engineering jobstothe1,900 jobsalreadythere. “These and otherinvestments inourmanu- facturing capacity are a response to the increasing demand forNovoNordisk’sprod- ucts, which ismainly driven bythe growing global incidence of diabetes,” explains HenrikWulff. “With the initiation of these large invest- ments, we plan to have sufficient capacity for current and future diabetes products well into the next decade,” he says, “and with thenew facility inMåløv, we’ll be able toproduce protein-based medicines such as semaglutide in tablet form ona large scale. Thisis something only few believed would bepossible justa couple ofyearsago.” GLOBAL DEMAND TRIGGERS MAJORPRODUCTION INVESTMENTS In 2015, Novo Nordisk announced plans for majorinvestmentsinnewproductionplants.
ADDRESSING LOCAL NEEDS Meeting local needs is also a priority for ProductSupply, which iswhy, inApril,Novo Nordiskopened a new insulin formulation andfilling facilityinRussiaand, inSeptember, announced thatitwouldbethefirstwestern pharmaceutical company to build a manu- facturing plant in Iran, for pre-filled insulin injection devices. “Local plants allow us toreact fast tolocal requirements and support our business in future keymarkets,” HenrikWulffsays. SECURING AHIGH-QUALITY SUPPLY Thecompliance and quality of products are the primary focus for all employees in Product Supply. Every NovoNordiskmanu- facturing facility, no matter where it is located, mustcomply fullywithinternational and national regulations aswellasadhere to the company’s global quality management system. “Wehaveaveryrobustquality management system at NovoNordisk,which we relyon when building competences and organi- sations across the world,” explains Henrik Wulff.“Weusethissystem, along with our considerable manufacturing expertise and knowledge, to ensure that we maintain consistentlyhigh standards inourproduction processesglobally.” THEADDED COMPLEXITY OFAN EXPANDING PORTFOLIO The complexity of Novo Nordisk’s manu- facturing hasincreased inthepastfew years as new products have been added to the company’s existing portfolio at a faster rate than atanytimepreviously.Inaddition, new products are typically more sophisticated molecules than first-generation products, generally demanding more complex pro- duction processes. “Our growing capacity and production complexity require best-in-class planning and execution capabilities,” Henrik Wulff points out. “Product Supply works 24 hours a day, 365 days a year, and has to fulfil many important tasks worldwide everyday toensure wesucceed inensuring high-quality products for more and more patients. “Ultimately, itall comes back to the needs of our patients. They expect high-quality products and wehave tomake surewecan deliver them – on time and in compliance with the requirements of the authorities – bothnow and inthefuture.” NOVO NORDISK PRODUCTION SITES AROUND THEWORLD LOCAL SITES A local site is established to meet specific local requirements STRATEGICSITES A strategic site is established for high-volume production and can supplyworldwide USA BRAZIL FRANCE DENMARK RUSSIA CHINA JAPAN ALGERIA 39
Fordecades, NovoNordiskhas been focus- ing on reducing its impact on the envi- ronment, and in1993 itbecame one ofthe firstglobal companies toreportannually on its environmental performance and set targets forfutureimprovements. The environmental strategy has changed over time since Novo Nordisk’s first Envi- ronment Department was established in 1973. Initially, the focus was on decreasing emissions of pollutants to air and water through so-called end-of-pipe solutions to ensure compliance. “Today, we have good systems and controls in place,” says Henrik Wulff, executive vicepresident in charge of ProductSupply.“Energy-,water-and waste- reducing initiatives are part of our normal operations.” ENVIRONMENTALSTRATEGY DOING MORE WITHLESS By 2020, all Novo Nordisk production facilities worldwide will be run on renewable power, but what about its suppliers’ CO 2 emissions? GHG PROTOCOL The Greenhouse Gas (GHG)Protocol Initiative is working with businesses, non-governmental organisations and governments with themission todevelop internationally accepted GHGaccounting and reportingstandards. TheProtocoldefines threescopes tohelp define direct and indirect emissionsources: 1.Direct GHG emissions from sources that are owned or controlled by the company, for example from production processes. 2. Indirect GHG emissions from the generation of purchased electricity consumed by thecompany. 3.Other indirect GHG emissions which are a consequence of the company’s activities but occur from sources not owned or controlled by the organisation. This includes emissions associated with waste, water, business travel, commuting and procurement. In2010,Jing TommyWanstarted working asFilling Professional inTianjin, China, and inAugust 2015,he joinedNovoNordiskProduction inHillerød,Denmark.
For the past 10 years, the environmental strategy has had a strong focus onreducing CO 2 emissions from Novo Nordisk’s own production plants. So much so that the company announced a long-term target in 2006:NovoNordiskcommitted tocutting its production-related CO 2 emissions by 10% within 10 years, using 2004 data as the baseline. “At the time, this was a really ambitious target, which weknew would bedifficult to achieve,” says Vibeke Burchard, senior global project manager for NovoNordisk’s environmental strategy. “We were and still are a growing company, and forecasts showed our energy consumption would increase threefold in this period – yet we committed toreducing emissions by10% in absolute terms.” RENEWABLE POWER This focus on emissions from production sitesprovedverysuccessful.Byimplementing energy efficiency programmes and using more renewable power – including switch- ing all its production plants in Denmark to renewable power from wind farms in the NorthSea –NovoNordiskactually went on toachieve thisambition in2010. Since then, the company has refined and optimised itsenergy management even fur- ther, and recently announced a bold, new target: that all Novo Nordisk production facilities worldwide would berunonrenew- able powerby2020. “Setting an absolute target of zero CO 2 emissions from power used at production sites in just five years is very ambitious, as our production is growing to meet the increasing global demand forourproducts. We’ve started identifying renewable sources,including wind and solarpower,for all our production facilities,” says Dorethe Nielsen, senior director of Corporate Envi- ronmental Management . NovoNordiskrecentlysigned a wind power contract for its production site in Tianjin, China, and iscurrentlyinvestigating the use ofrenewable powerforitsplants inClayton, NorthCarolina in the US, and Chartres in France. Onceallitspowerconsumption comesfrom renewable sources, the company aims to replace the steam supply in its production facilities, which is currently based on fossil sourcessuch ascoal orgas, with renewable sourcessuchasbiomass orbiogas. Therealisationofthisambition recentlycame a bit closerwhen DONGEnergy, an energy company supplying NovoNordiskwithsteam forinsulinproduction inDenmark,initiated a feasibilitystudytoshiftfromcoaltobiomass. A positive outcome tothis study will mean renewable steamsupplyfrom2019onwards. Thefeasibility studyistheresultofapartner- shipwithotherlocalcompanies. CLIMATE INFOCUS Nowthe company isready totake the next step in its environmental strategy. “Once we’re using renewable energy in all our productionfacilities,we’llhavedoneasmuch as we can with direct carbon emissions,” DoretheNielsen explains. “We’re therefore broadening thescopeofourstrategyandwill work on reducing the CO 2 impact from so- calledindirectemissions–theseareemissions fromsourcesnotcontrolledbyus,suchasthe goods and serviceswe purchase, from raw materialstobusinessflights.” NovoNordiskwillfocus onspecific types of indirect emission, as categorised by the internationally accepted Greenhouse Gas Protocol (see box). “We’ll prioritise areas where we believe there are significant op- portunities for us to reduce CO 2 emissions. Working closely with our largest suppliers willbevital,tofind outhowthey’rereducing emissions and if there’s scope for improve- ment,” shesays. While indirect emissions are a relatively new area forNovoNordisk,thecompany is already working with key suppliers of raw materials topromote energy efficiency and the useofrenewable energy. From recent analyses, Novo Nordisk has alsoacquired agood understanding oftwo other types of indirect emission: business flights and leased company cars, and, according to Dorethe Nielsen, is planning initiatives to reduce emissions from these sources.Forthe othercategories, thefocus will initially be on getting solid data based on which decisions about CO 2 reduction initiatives can bemade. Jakob Riis, executive vice president, is the chairman of NovoNordisk’s Social & Envi- ronmental Committee. He explains the rationale for the broader scope of the company’s environmental strategy: “While we’ll continue to challenge ourselves and improve in the areas of energy and water consumption, waste reduction and direct carbon emissions, we’re ready to broaden the scope of our responsibility to include indirect CO 2 emissions. Withoverwhelming scientific evidence of the increased rate and impact of climate change, we simply must setourselves ambitious targets inthis area,” hesays. “Which indicators to use for measuring performance is a tricky matter,” he ack- nowledges . “With all our plants soon using renewable energy for power, it’s impossible to keep lowering CO 2 emissions in absolute terms when our company is growing as much as it is. We have con- cluded that the best way to measure our CO 2 performance is to measure CO 2 emissions relative to the number of patients treated with ourproducts, orCO 2 emissions per treated patient if you will. Our ambition is to bring that number down.” FOCUS OF THE NEW CLIMATE AMBITION SERVICES Businessflights, companycars RAWMATERIALS Glucose,ethanol, plastic, glass WASTE Productionwaste, productwaste DISTRIBUTION Road,air, sea PRODUCTION Electricity, steam, facilities PURCHASED GOODS Officesupplies, IT equipment NOVO NORDISK ANNUAL REPORT2015 OUR BUSINESS 41
Effective enterprise risk management is all about identifying risks early,assessing them accurately and taking action tomitigate them sothattheywillnotpreventthecompany fromachieving itsbusiness objectives. Sounds easy, but of course it is more complicated in reality.Factisthatawell-functioning riskmanagement processiskey toensuring NovoNordisk’slong-termbusiness successbecause risks are everywhere and some of them can cause serious damage if managed poorly. Inthe pharmaceutical industry, most risksfall into one of the seven categories listed on the notepad. And while NovoNordisk’soverall riskprofile–theconsolidated assessment ofalltherisksfacing Novo Nordisk–seldom changes significantly from yeartoyear,individual risksdo. Jesper Brandgaard, NovoNordisk’schief financial officer, heads the company’s RiskManagement Board.Asanexample ofariskthathas increased in both likelihood and potential impact during 2015, he cites pressure on Novo Nordisk’s modern insulin prices in China, which islikelytogrow in2016 due toa new bidding reformwhich was implemented inJune2015. Asked about risksthat have become smaller during the year,Jesper Brandgaard mentions a regulatory risk associated with Tresiba ® : “When we entered the year,we did notknow whether the USFDA wouldapproveTresiba ® based oninterimdatafromtheDEVOTEstudy. Whenitturnedoutthattheydid,wecouldremovethatriskfromour riskgrid.” Atthe same time, he stressesthat the final resultof the DEVOTEstudywillnotbeknown beforethesecondhalf of2016. As another example, he mentions a specific legal risk, the product liability lawsuits in the US targeting incretin-based products, in- cluding Victoza ® .InNovember,a federal judge handling mostofthe cases dismissed the cases against Novo Nordisk and other phar- maceutical companies.Although the ruling has been appealed, this means the likelihood of a significant financial impact from these cases has beenreduced. Thefollowing is an overview of the seven main types of riskthat NovoNordiskfaces. MANAGING RISKS DELAYS ORFAILURE OFPIPELINE PRODUCTS Development of a new pharmaceutical product is an expensive undertaking that can take morethan 10 years.Itincludes extensive non-clinical testsand clinical trialsaswellasan elaborate regulatory approval process, including approval of the production facilities. During theprocess,varioushurdles may delay thedevelopment ofa potential product candidate and add substantial expenses.In some cases, significant obstacles could lead to the company eventually deciding to abandon the development of the potential product candidate.Datafromthepharmaceutical industry indicate thatthere isalessthan 35%likelihood ofabiologic diabetes productcandidate inphase 1ultimately being approved formarketing, while thelikeli- hood of success is around 60% for products in phase 2, rising to around 80% for products in phase 3. However,there issignificant uncertainty regarding the timing and success of the regulatory approvalprocess. MARKET RISKS Theprincipal marketrisksNovoNordiskexperiences are: • Pricepressureand reimbursement restrictionsbypayers • Thelaunch ofnew products byestablished competitors • Increasedcompetition fromproducersofbiosimilar medicines. Europe, China and the US are all main markets for NovoNordisk wherepayers–bothgovernments andprivatepayers–takemeasures to limit spending on medicines, typically by driving down prices, demanding higher rebates and/or restricting access to and reim- bursement ofproducts.Thisisunlikely tochange intheforeseeable future. For Novo Nordisk, reimbursement restrictions pose a sig- nificant riskwhen launching anew product suchasTresiba ® .Despite thepatient benefits and data supporting thehealth-economic bene- fitsofthisnewbasal insulin, itisnotalways possibletoobtain market accessunder what NovoNordiskconsidersreasonable conditions.In some countries, the company may therefore decide not to launch Tresiba ® orothernew products unless conditions change. New products from established or new competitors are another inherent market risk. In the basal insulin segment, a competitor launched a biosimilar version of the best-selling modern insulin product insomemarkets in2015 and islikelytolaunch intheUSby the end of 2016.Howand towhat extentthese events willchange the market dynamics isdifficult toassess at present.In addition to these global risks,insome countries inthe International Operations region, political instability orarmedconflicts mayposearisktoNovo Nordisk’sbusiness forvarying lengths oftime. SUPPLY DISRUPTIONS Failureorbreakdown atoneofNovoNordisk’sorthecompany’s key suppliers’ vital production facilities could adversely affect business operations and potentially cause employee injuries orinfrastructure damage.Mitigating actions include measurestopreventand respond tofires, annual inspections, back-upfacilities and safety inventories. Toreducesupply risksand optimise costsand logistics, NovoNordisk has established production sitesinseveralcountries. QUALITY AND PRODUCT SAFETY ISSUES Qualityandproductsafetyissuesmayariseif,forexample,aproduction facility isnotcontinuously inregulatory compliance, a product isnot withinspecifications orifsideeffects thatwerenotdetected inclinical trialsbecome apparent when a productisused forlonger periodsof time.NovoNordiskproactivelymanages suchrisksthrough itsquality The pharmaceutical industry isassociated with potentially serious risks that investors shouldkeepinmindwhenmaking investment decisions. Novo Nordisk is noexception. 42
management system, a key priority of which is to safeguard product quality and minimise risks to patient safety. The quality management system aims to ensure that the company is in compliance with all regulatory requirements. It includes standard operating procedures, quality and release controls, quality audits, quality improve- ment plans and systematic senior management reviews. FINANCIAL RISKS Novo Nordisk’s main financial risks relate to exchange rates and tax disputes. Novo Nordisk’s reporting currency and the functional currency of corporate operations is the Danishkrone,which iscloselylinkedtotheeurowithin a narrow range of 2.25%. However, the majority of the company’s sales are in US dollars, Chinese yuan, Japanese yen and British pounds. Exchange rate risk is therefore the company’s biggest financial risk, and the risk has grown in importance as the size of international markets and the share of sales in different currencies have increased. To manage this risk,thecompany hedges expectedfuturecashflowsforselected keycurrencies.Readmoreabout howNovo Nordiskmanages this risk in notes 4.2 and 4.3on pp81–84. Inthecourseofconducting businessglobally, transferpricingdisputes with taxauthorities may occur.NovoNordisk’spolicy istopursue a competitivetaxlevel,meaning around theaverage forthecompany’s peergroup, ina responsibleway.Thismeans paying relevanttaxesin jurisdictionswhereitsbusiness activitygenerates profits.Asageneral rule,NovoNordisk’saffiliates pay corporatetaxesinthe countriesin which they operate. Tomanage uncertainties regarding tax, Novo Nordiskhas negotiated multi-year transfer pricing agreements with tax authorities in key markets. Read moreabout the taxes paid by NovoNordiskin2015innote2.6onpp70–71. INFORMATION TECHNOLOGY RISKS Well-functioning ITsystems arecritical forNovoNordisk’sability to operate effectively.Furthermore,they hold confidential information that, if disclosed, could have a severe impact on Novo Nordisk’s competitive situation.Aninformation securitystrategy isinplace to mitigate theriskofintruderscausing damage tosystemsand gaining accesstocriticaldata and systems.Specific measures include aware- ness campaigns, access controls, and intrusion detection and pre- ventionsystems. BUSINESS ETHICS AND LEGAL RISKS Business ethicsviolations, patent and contractdisputes arethemain risksinthisarea.Thepharmaceutical industry istightly regulated in many respects, including what promotional claimsitcanmakeabout itsproductsandhowitcaninteractwithdoctorsandotherhealthcare professionals. IntheUS,NovoNordisksettled two civilcases with the USDepart- ment of Justice in June 2011 regarding alleged improper marketing ofNovoSeven ® .Aspartofthesettlement, NovoNordisk’sUSaffiliate entered into a five-year Corporate Integrity Agreement with the OfficeoftheInspectorGeneraloftheUSDepartment ofHealthand Human Services. Under that agreement, the US affiliate added additional reporting and other procedures to its already robust compliance programme.Read moreabout these and otherpending litigations against Novo Nordisk and investigations involving the company innote3.7onp78. Thecase mentioned above underlines the potential business ethics orlegal risksassociated with being a pharmaceutical company. To minimise the riskof violating national and international regulations, NovoNordiskhas, overthepast decade, strengthened itsglobal and regional business ethicscompliance programmes. Novo Nordisk’s business model is based on developing new, innovative products, and when the company makes significant new inventions, itwilltypically seek topatent them.Intellectual property risks occur if, for example, a government does not recognise the validity of patents or is unable to uphold patent rights, or if a competitorinfringes a NovoNordiskpatent orchallenges itsvalidity. NOVO NORDISK’S RISK MANAGEMENT POLICY InNovoNordiskwewillproactively manage risktoensurecontinued growth of our business and to protect our people, assets and reputation.Thismeans that wewill: • utilise an effective and integrated risk management systemwhile maintaining business flexibility • identify and assessmaterial risksassociated with ourbusiness • monitor,manage and mitigate risks. Read more about Novo Nordisk’s risk management process at novonordisk.com/about_us .
SHARES AND CAPITALSTRUCTURE Through open and proactive communication, the company seeks to provide the basis for fair and efficient pricing of itsshares. SHARE CAPITAL AND OWNERSHIP Novo Nordisk’stotal share capital of DKK 520,000,000isdividedintoanAsharecapital ofnominally DKK107,487,200and a Bshare capital of nominally DKK412,512,800. The company’sAsharesarenotlistedandareheld by NovoA/S, a Danishpublic limitedliability company whollyowned bytheNovoNordisk Foundation. TheFoundation has a dual ob- jective: to provide a stable basis for the commercialand researchactivitiesconducted bythecompanies within theNovoGroup(of which NovoNordiskis the largest), and to supportscientificand humanitarian purposes. AccordingtotheArticlesofAssociationofthe Foundation, theAsharescannotbedivested. Asof31December2015,NovoA/Salsoheld nominal valueofDKK32,762,800 ofBshare capital.NovoNordisk’sBsharesarelistedon Nasdaq Copenhagen and on the NewYork Stock Exchange as American Depository Receipts (ADRs). Novo Nordisk’s A and B shares are calculated in units of DKK0.20. Each A share carries200 votes and each B share carries20 votes. As NovoNordisk’sB sharesareinbearerform,nocompleterecord of all shareholdersexists.Based on available sourcesof information about the company’s shareholdersas of 31 December2015, it is estimated that shares were geographically distributed as shown in the chart on the oppositepage.Asof31December2015,the free float of listed B shares was 89.5% (of which approximately 13.1% are listed as ADRs),excluding the NovoA/S holding and Novo Nordisk’s holding of treasury shares which, as of 31 December2015, was DKK 10,433,741 nominally. Fordetails about the sharecapital,seenote4.1onpp79–80. CAPITAL STRUCTURE AND DIVIDEND POLICY Novo Nordisk’s Board of Directors and Executive Management consider that the currentcapital and share structureof Novo Nordisk serves the interests of the share- holders and the company well, providing strategic flexibility topursue NovoNordisk’s vision.NovoNordisk’scapital structurestrat- egy offers a good balance between long- term shareholder value creation and com- petitiveshareholderreturnintheshortterm. NovoNordisk’sguiding principle isthat any excesscapital, after the funding of organic growth opportunities and potential acqui- sitions, should be returnedtoinvestors.The company’s dividend policyappliesapharma- ceutical industry benchmark to ensure a competitive payout ratio for dividend pay- ments, which are complemented by share repurchase programmes. The Board of Dir- ectorsplans tointroducean interimdividend in August, 2016. Asillustratedon the right, Novo Nordisk has continuously increased both thepayout ratioand thedividend paid overthelastfiveyears.Thedividend for2014 recordedinMarch 2015wasequal to DKK 5.00perAandBshareofDKK0.20aswellas forADRs.Thiscorrespondstoa payout ratio of 48.7%, which isbroadly in-line with the 2014 pharma peer group average of 54%. For2015,theBoardofDirectorswillpropose a dividend of DKK6.40, which corresponds toapayout ratioof46.6%.Adjusting forthe partial divestment of NNITA/S, where the net profit impact was returned to share- holdersthrough a DKK2.5billionexpansion of the 2015 share repurchase programme, thepayout ratiowillbe50.1%.NovoNordisk does not pay a dividend on its holding of treasury shares. Shareholders’ enquiries concerning dividend payments and share- holder accounts should be addressed to InvestorService.Readmoreonthebackcover. During the 12-month period beginning 30 January 2015, Novo Nordisk repurchased shares worth DKK17.5 billion. Since 2008, the share repurchase programme has primarilybeen conducted inaccordance with the provisions of European Commission Regulation No2273/2003 of 22 December 2003 (also known as the Safe Harbour Regulation). In such a programme, financial institutions areappointed as lead managers to execute the repurchases independently and without influence fromNovoNordisk. SHARE REPURCHASE PROGRAMME FOR2016/2017 Forthe next 12 months, NovoNordiskhas decided to implement a new share re- purchase programme. The expected total repurchase value of Bshares amounts toa cash value of up to DKK14 billion. Novo Nordiskexpects to implement the majority of the new share repurchase programme according to the Safe Harbour Regulation. The size of the 2016 share repurchase programme isadjusted fortheimpact ofthe interim dividend. In March 2016, at the Annual General Meeting, the Board of Directorswillproposea furtherreduction in thecompany’s Bsharecapital,corresponding to approximately 1.92% of the total share capital, by cancelling 50,000,000 treasury shares. After the implementation of the share capital reduction, Novo Nordisk’s share capital will amount to DKK 510,000,000,divided intoAsharecapital of DKK 107,487,200 and B share capital of DKK402,512,800. SHARE PRICEDEVELOPMENT Novo Nordisk’s share price increased by 54% between its2014 close of DKK260.3 and the 30 December 2015 close of DKK 399.9.Forcomparison, theDanishOMXC20 CAPstockindex increased by29% and the pharma peergroup increased by4% during 2015. Theincrease in NovoNordisk’sshare price during 2015 reflects its sustained leadership position in the growing diabetes care market, coupled with a continued improvement in operating margins and the progress of keyR&Dprojects, including the approval of Tresiba ® in the USand the clin- icalprogress with thenovel GLP-1analogue semaglutide. The total market value of NovoNordisk’sBshares, excluding treasury shares, was DKK 804 billion as of 30 December2015. COMMUNICATION WITH SHAREHOLDERS Tokeep investors updated about perform- ance and the progress of clinical devel- opment programmes, Novo Nordisk hosts conference callswithExecutiveManagement following key events and the release of financial results. Executive Management and InvestorRelations alsotravelextensively to ensure that all investors with a major holding of Novo Nordisk shares can meet with the company on a regular basis and thatanumber ofotherinvestorsand poten- tialinvestorsalsohaveaccesstothecompany’s Management andInvestorRelations. ANALYST COVERAGE NovoNordiskiscurrentlycoveredby37sell- side analysts, including the major global investment banks that regularly produce research reportson NovoNordisk.Alistof analysts covering Novo Nordisk can be found atnovonordisk.comunder‘Investors’. Company announcements from 1995 onwards, financial, socialand environmental results, a calendar of investor-relevant events, investor presentations, background information and soonarealsoavailable. NOVO NORDISK ANNUAL REPORT2015 44 GOVERNANCE, LEADERSHIP ANDSHARES
0 8 16 24 32 40 400 450 500 550 600 DEVELOPMENT IN SHARE CAPITAL Sharecapital DKKmillion % DKKbillion CASH RETURN TO SHAREHOLDERS ANNUAL CASH RETURN TOSHAREHOLDERS Dividend Share repurchase Free cashflow GEOGRAPHIC DISTRIBUTION OFSHAREHOLDERS * % of share capital 2014 2015 Denmark Other North America UKand Ireland * Calculated using shareholders’ registered home countries. Note: Dividends are allocated to the year of dividend pay. 0 10 20 30 40 50 2012 (–2%) (–2%) (–2%) 2013 20142012 2013 2014 2015 20152016E 2016E Note: Treasury shares are included in share capital but have no voting right. SHARE AND OWNERSHIPSTRUCTURE OWNERSHIP STRUCTURE NovoNordisk Foundation NovoA/S Institutional and private investors 75.0% ofvotes 27.0% ofcapital 25.0% ofvotes 73.0% ofcapital B shares 2,063m shares A shares 537mshares Novo Nordisk A/S (–4%) SHARE PRICEPERFORMANCE SHARE PRICEPERFORMANCE Novo Nordisk share price and indexed peers NovoNordisk Pharmaceutical industrypeers * OMXC20CAP * Pharma peers comprise: AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, J&J, Merck & Co, Novartis, Pfizer, Roche, Sanofi and Teva. 180 240 300 360 DKK 420 Mar Jun Sep Dec Mar 2014 Jun Sep Dec 2015 PRICE DEVELOPMENT AND MONTHLY TURNOVER OF NOVO NORDISK BSHARES Turnover of B shares(left) Novo Nordisk’s B share closing prices(right) 0 5 10 15 20 25 0 90 180 270 360 450 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2015 DKKbillion NOVO NORDISK ANNUAL REPORT2015 GOVERNANCE, LEADERSHIP AND SHARES 45
GOVERNANCESTRUCTURE SHAREHOLDERS Shareholders have ultimate authority overthecompany and exercise theirrights tomake decisions at general meetings. Resolutions can generally be passed by a simple majority. However, resolutions to amend the Articles of Association require two-thirds of votes cast and capital represented, unless other adoption requirements are imposed bytheDanishCompaniesAct. At the annual general meeting, shareholders approve the annual reportandanyamendments tothecompany’s ArticlesofAssociation. Shareholders alsoelectboardmembersandtheindependent auditor. NovoNordisk’sshare capital isdivided into Aand Bshares.Special rights attached toAsharesinclude pre-emptive subscription rights in the event of an increase in the A share capital and pre-emptive purchase rightsintheeventofasaleofAshares,while Bsharestake priority for liquidation proceedings.* Read more about shares and capital structureonp44. BOARD OFDIRECTORS NovoNordiskhasatwo-tiermanagement structureconsisting ofthe Board of Directorsand Executive Management . Thetwo bodies are separate and no one serves as a member of both. The Board of Directorsdetermines the company’s overallstrategy and follows up onitsimplementation, supervisestheperformance, ensuresadequate management and organisation and, as such, actively contributes to developing the company as a focused, sustainable, global pharma- ceutical company.TheBoard ofDirectorssupervises ExecutiveMan- agement initsdecisions and operations.TheBoardofDirectorsmay also issue new shares or buy back shares in accordance with authorisations granted bythe annual general meeting and recorded inthemeeting minutes.Forminutes fromannual general meetings, seenovonordisk.com/about_us.TheBoardofDirectorshas12mem- bers, eight of whom are elected by shareholders and four by employees inDenmark.NovoNordisk’sBoardofDirectorsmetseven timesduring2015. Shareholder-elected board members serve a one-yearterm and may be re-elected. Members must retire at the first annual general meeting after reaching the age of 70. Five of theeight shareholder- elected board members are independent as defined by the Danish CorporateGovernanceRecommendations. Readmoreonpp52–53. A proposal for nomination of board members is presented by theNominationCommitteetotheBoardofDirectors,taking into account required competences as defined by the Board of Directors’ competence profile and reflecting * A shares take priority for dividends below 0.5%. Bshares take priorityfordividends between 0.5and5%. However,inpractice, A shares and B shares receive the same amount of dividend per share. The dividend per share approved at the Annual General Meeting in March 2015 was DKK 5 for allshares of DKK 0.20, equivalent to a dividend percentage of 2,500%, making the dividend differentiation in the Articles of Association lessrelevant. In 2015, the Board of Directors reached its diversity targets as set out in 2013 and consequently increased its diversity ambition even further by setting out new targets for 2019. The Board of Directors established a Remuneration Committee to enhance the process for preparing proposals for the remuneration of the Board of Directors and Executive Management. Furthermore, the Board of Directors decided to reorganise Executive Management to enhance the Board’s visibility of Novo Nordisk’s international business operations and support further development of key leadershiptalents. CORPORATE GOVERNANCE
CONTINUED the result of a self-assessment process facilitated by internal or external consultants. The assessment process is based on written questionnaires and evaluates the Board of Directors’ composition and theskillsofitsmembers, including whether each board member and executive participates actively in board discussions and contributes with independent judgement. Toensure that discussions include multiple perspectives representing the complex, global pharmaceutical environment, the Board of Directorsaspires to be diverse in gender and nationality. Currently, threeshareholder-elected board members arefemale and sixof the eightshareholder-electedboardmembersarenon-Danes.In2015,the BoardofDirectorsincreaseditsdiversityambition furtherand setout new targets with the aim that by2019 itwillconsistof atleast two shareholder-elected board members with Nordicnationality and at leasttwoshareholder-electedboardmemberswithanationality other thanNordic–andatleastfourshareholder-electedboardmembersof each gender.Inaccordance with section 99bof theDanishFinancial Statements Act,NovoNordiskdisclosesitsdiversitypolicy,targetsand currentperformance in the UNGlobal Compact Communication on Progress,which isavailable atnovonordisk.com/annualreport. Theself-assessment conducted in2015 was facilitated internally and revealed continued strong performance by the Board and Executive Management . The process also resulted in the identification of a number of areas within research, manufacturing and sales where more insight will be provided to the Board. In order to support continued fulfilment of the Novo Nordisk Way, criteria for board members include integrity, accountability, fairness, financial literacy, commitment and desireforinnovation.Members arealso expected to have experience of managing major companies that develop, manufacture and market products and services globally. The competence profile, which includes the nomination criteria,isavail- able atnovonordisk.com/about_us. UnderDanishlaw,NovoNordisk’semployees inDenmarkareentitled to be represented by half of the total number of board members elected at the annual general meeting. In 2014,employees elected four board members from among themselves –two male and two female, all Danes. Board members elected by employees serve a four-yeartermand have the same rights, duties and responsibilities asshareholder-electedboard members. CHAIRMANSHIP Theannual general meeting directlyelectsthechairman and thevice chairman of the Board of Directors. The Chairmanship carries out administrative tasks, such as planning board meetings toensure a balance between overall strategy-setting and financial and managerial supervision of the company.Othertasks include review- ing thefixedassetinvestment portfolio.InMarch 2015,the Annual General Meeting re-elected the Chairman, Göran Ando, and the Vice Chairman, Jeppe Christiansen. See novonordisk.com/about_us fora reportontheChairmanship’sactivities. AUDIT COMMITTEE Thefourmembers oftheAuditCommittee areelected bytheBoard ofDirectorsfrom among itsmembers.Pursuant totheUSSecurities Exchange Act, two members qualify as independent while two members relyon an exemption tothe independence requirements. Inaddition, two members have been designated asfinancial experts as defined by the US Securities and Exchange Commission (SEC). UnderDanishlaw, two members qualify asindependent –ofwhom one also qualifies as financial expert. Onemember isan employee representative.TheAudit Committee assists the Board of Directors with oversight of the external auditors, the internal audit function, theprocedureforhandling complaints regarding accounting, internal accounting controls, auditing or financial reporting matters and business ethicsmatters, financial, socialand environmental reporting, business ethics compliance, post-completion reviews and post- investment reviews, long-term incentive programmes and infor- mation security.In2015,theBoardofDirectorselected LizHewittas Chairman and Jeppe Christiansen, Sylvie Grégoireand Stig Strøbæk asmembers.Eivind Kolding was elected asan observerontheAudit Committee. See novonordisk.com/about_us for a report on the AuditCommittee’sactivities. NOMINATION COMMITTEE TheNominationCommitteeconsistsoffivemembers.Threemembers qualifyasindependent, whileonememberisanemployee representative. TheNomination Committee assists the Board with oversight of the competence profile and composition of the Board, nomination of members and committees, and other tasks on an ad hoc basis as specificallydecidedbytheBoard.In2015,theBoardofDirectorselected Göran Ando asChairman and Bruno Angelici, Liz Hewitt, Liselotte Hyveled and Mary Szela as members. See novonordisk.com\about_us forareportontheNominationCommittee’sactivities. REMUNERATION COMMITTEE The Board of Directorsestablished a Remuneration Committee in 2015.TheRemuneration Committee consists of five members.Two members qualify asindependent, while onemember isan employee representative.Thechairman of the committee isnot independent . TheRemuneration CommitteeassiststheBoardwithoversight ofthe remuneration policy as well as the actual remuneration of board members, itscommittees and Executive Management . In 2015, the Board of Directors elected Göran Ando as Chairman and Jeppe Christiansen, Thomas Paul Koestler, Søren Thuesen Pedersen and Mary Szela asmembers.Seenovonordisk.com\about_us forareport ontheRemuneration Committee’sactivities. 47
ASSURANCE CORPORATE GOVERNANCE CODES AND PRACTICES COMPLIANCE GOVERNANCE STRUCTURE Danish and foreign laws andregulations Corporate governance standards Novo Nordisk Way Audit of financial data and review of social and environmental data (internal andexternal) Facilitation and organisational audit (internal) Quality audit and inspections (internal andexternal) Board ofDirectors Shareholders Executive Management Organisation Chairmanship* Nomination Committee Remuneration Committee Audit Committee * The Chairmanship is directly elected by the annual general meeting. EXECUTIVE MANAGEMENT ExecutiveManagement isresponsiblefortheday-to-daymanagement ofthecompany.In2015,oneexecutiveleftand fourexecutiveswere appointed bythe Board of Directors.Thefournew executives were elevated from leaders ofthecommercial activities intheUS,Europe and International Operationsand ofProductSupply toexecutivevice presidents and members of Executive Management . Thefour new executives are not registered with the Danish Business Authority. Executive Management now consists of the president & CEO,plus eight executives.Theyareresponsible fortheoverallconduct of the business and all operational matters, the organisation of the company, allocation ofresources,determination and implementation of strategies and policies, direction-setting, and ensuring timely reporting and provisionofinformation totheBoardofDirectorsand NovoNordisk’sstakeholders.Executive Management meets at least once a month and often more frequently. The Board of Directors appoints members of Executive Management and determines its remuneration. The Chairmanship reviews the performance of the executives. ASSURANCE The company’s financial reporting and the internal controls over financial reporting processes are audited by an independent audit firmelectedattheannual general meeting.AspartofNovoNordisk’s commitment to its social and environmental responsibility, the company voluntarily includes an assurance report for social and environmental reporting intheannual report.Theassurance provider reviews whether the social and environmental performance information coversaspects deemed tobe material, and verifies the internalcontrolprocessesfortheinformation reported. Novo Nordisk’s internal audit function provides independent and objective assurance, primarily within internal control of financial processes,ITand business ethics.Toensurethattheinternalfinancial audit function works independently of Executive Management, its charter,auditplanandbudget areapproved bytheAuditCommittee. Threeothertypesofassurance activity–quality audits, organisational audits and values audits, called facilitations – help ensure that the company adheres tohigh quality standards and operates inaccord- ance with theNovoNordiskWay. COMPLIANCEWITH CORPORATEGOVERNANCECODES NovoNordisk’sBsharesarelistedonNasdaqCopenhagen and onthe New YorkStock Exchange (NYSE)as American DepositoryReceipts (ADRs). The applicable corporategovernance codes for each stock exchange and a reviewof NovoNordisk’scompliance areavailable at novonordisk.com/about_us. Inaccordancewithsection107boftheDanishFinancialStatementsAct, NovoNordiskdisclosesitsmandatory corporategovernance reportat novonordisk .com/about -novo-nordisk/corporate -governance/ Recommendations-and-practices.html.NovoNordiskadherestoallbut thefollowingrecommendations: •The responsibility for the remuneration policy applicable to the employeesingeneral lieswithExecutiveManagement andnotwith the RemunerationCommittee. •Threeemployment contractsforExecutiveManagement entered intobefore2008 allowforseverancepayments ofmorethan 24 months’ fixedbasesalarypluspension contribution. •ThemajorityoftheAuditCommittee’smembers and the RemunerationCommittee’smembers respectivelyarenot independent. NovoNordiskcomplies with the corporategovernance standards of NYSEapplicabletoforeignlistedprivateissuers.Asacontrolledcompany, NovoNordiskisnotobligedtocomplywithallthestandardsestablished by NYSE. Furthermore,NovoNordisk,as a foreign private issuer,is permittedtofollowhomecountrypractice,whichisthecaseinrelation toindependence requirements,audit committee,equitycompensation plans, code of business conduct and ethics, and CEOcertification.A summary of the significant ways in which NovoNordisk’scorporate governancepracticesdifferfromtheNYSEcorporategovernancelisting standards can be found in the corporate governance report at novonordisk .com/about -novo-nordisk/corporate -governance/ Recommendations-and-practices.html. NovoNordiskispartoftheNovoGroupandadherestotheCharterfor CompaniesintheNovoGroup,whichisavailableatnovo.dk.However, allstrategicand operationalmattersaresolelydecidedbytheBoardof Directorsand ExecutiveManagement ofNovoNordisk. NOVO NORDISK ANNUAL REPORT2015 48 GOVERNANCE, LEADERSHIP ANDSHARES
BOARD OFDIRECTORS IN 2015, THE BASE FEE FOR MEMBERS OF THE BOARD OF DIRECTORS WAS DKK 600,000 (DKK 500,000 IN2014). 2015 2014 Feefor Feefor DKKmillion Fixed basefee ad hoc tasksand committeework Travel allowance Total Fixed basefee ad hoc tasksand committeework Travel allowance Total Göran Ando 3, 4 (BC, NC andRC) 1.7 – 0.1 1.8 1.5 – 0.1 1.6 Jeppe Christiansen (BV, AM andRM) 1.2 0.3 – 1.5 1.0 – – 1.0 Bruno Angelici(NM) 0.6 0.1 0.1 0.8 0.5 0.1 0.1 0.7 Sylvie Grégoire 1 (AM) 0.5 0.2 0.2 0.9 – – – – Liz Hewitt (AC andNM) 0.6 0.7 0.1 1.4 0.5 0.4 0.1 1.0 Liselotte Hyveled 1 (NM) 0.6 0.1 – 0.7 0.4 – – 0.4 Thomas Paul Koestler(RM) 0.6 0.1 0.2 0.9 0.5 – 0.3 0.8 Eivind Kolding 1 (AO) 0.5 – – 0.5 – – – – Anne MarieKverneland 0.6 – – 0.6 0.5 – – 0.5 Søren Thuesen Pedersen(RM) 0.6 0.1 – 0.7 0.5 0.1 – 0.6 Stig Strøbæk(AM) 0.6 0.3 – 0.9 0.5 0.3 – 0.8 Mary Szela 1 (NM andRM) 0.5 0.2 0.2 0.9 – – – – HelgeLund 2 0.1 0.1 0.1 0.3 0.4 0.2 0.1 0.7 HannuRyöppönen 2 0.1 0.1 0.1 0.3 0.5 0.5 0.1 1.1 HenrikGürtler 2 – – – – 0.1 – – 0.1 UlrikHjulmand-Lassen 2 – – – – 0.1 – – 0.1 Total 8.8 2.3 1.1 12.2 5 7.0 1.6 0.8 9.4 5 BC=Board chairman, BV=Board vicechairman, AC=Audit Committee chairman, AM =Audit Committee member, AO=Audit Committee observer, NC=Nomination Committee chairman, NM=Nomination Committee member, RC=Remuneration Committee chairman, RM=Remuneration Committee member. 1.Liselotte Hyveled was firstelected inMarch 2014.Sylvie Grégoire, Eivind Kolding and Mary Szela werefirst elected inMarch 2015.2.HelgeLundandHannuRyöppönenresigned asofMarch2015.HenrikGürtlerandUlrikHjulmand-LassenresignedasofMarch2014.3.NovoNordiskprovides secretarial assistance tothe chairman inDenmark and the UK.4.As Göran Ando also holds the position of chairman of the Board, he has notreceived afee as chairman of the Nomination Committee and the Remuneration Committee.5.Excluding social security taxespaid byNovoNordiskamounting tolessthan DKK1million (lessthan DKK1million in2014). REMUNERATION At the Annual General Meeting in March 2015, the fixed base fee of the Board of DirectorswasincreasedfromDKK500,000to DKK600,000 afternothaving been adjusted forfouryears. Remunerationof the Boardof Directorsand Executive Management is assessed on an annual basis against a benchmark of Nordic companiesaswellasEuropeanpharmaceutical companiesthataresimilartoNovoNordiskin size,complexityandmarketcapitalisation.The resultsarepresentedtotheBoardofDirectors by the Remuneration Committee at its Oc- tobermeeting.Thecompany strivesforsim- plicity when devising the remuneration package, and itsremunerationprinciplespro- vide guidance for the remuneration of the BoardofDirectorsandExecutiveManagement. Theseprinciplesareavailable atnovonordisk. com /about -novo -nordisk /corporate - governance/remuneration .html. BOARD OFDIRECTORS’ REMUNERATION Theremuneration of NovoNordisk’sBoard of Directorscomprises a fixed base fee, a multiplierofthefixedbasefeefortheChair- manship and members of the company’s committees, fees for ad hoc tasks and a travelallowance.Furtherinformation onthe remuneration of the Board of Directorsis available atnovonordisk.com/about_us. At the October meeting, the Board of Directors agrees on recommendations for remuneration levels for the next financial year.Inconnection with theapproval ofthe annual report, the Board endorses the actual remuneration for the past financial year and the recommendation on remu- neration levelsforthecurrentfinancial year. These are then presented to the annual general meeting forapproval. TRAVEL AND EXPENSES All board members who reside outside of Denmark are paid a fixed travel allowance for each board meeting. Expenses such as travel and accommodation in relation to board meetings as well as those associated with continuing education are reimbursed. NovoNordiskalso pays social security taxes imposed by foreign authorities. Further in- formation ontraveland expensesisavailable atnovonordisk.com/about_us. EXECUTIVE MANAGEMENT’S REMUNERATION The remuneration of NovoNordisk’s Exec- utive Management is proposed by the Re- muneration Committee and approved by theBoard ofDirectors.Remuneration pack- ages for executives comprise a fixed base salary,acash-based incentive, ashare-based incentive, a pension contribution and other benefits. For executives on international assignments, the remuneration package is generally based onan equalised host coun- try net salary during the length of the assignment and relocation benefits includ- ing accommodation and school arrange- ments.Thesplitbetween fixed and variable remuneration is intended to result in a reasonable partofthesalary being linked to performance, while promoting sound, long- term business decisions to meet the com- pany’s objectives. All incentives are subject toclaw-backifitissubsequently determined that payment was based on information that was manifestly misstated. FIXED BASE SALARY Thefixed base salary isintended toattract and retain executives with the professional and personal competences requiredtodrive thecompany’s performance. CASH-BASED INCENTIVE The short-term cash-based incentive is designed to incentivise individual perform- ance. The incentive is dependent on the achievement of a number of predefined short-term financial, process, people and customer targets relating tothe executive’s functional area and linked to goals in the company’s Balanced Scorecard as well as theachievement ofa number of personal CONTINUED NOVO NORDISK ANNUAL REPORT2015 GOVERNANCE, LEADERSHIP AND SHARES 49
targets relating to the individual executive and their position. Short-term targets for the Chief Executive Officer are set by the Chairman of the Board of Directors,while the targets for the other members of Executive Management aresetby the CEO. The Chairmanship evaluates the degree of achievement foreach member of Executive Management, based on input from the CEO. In June 2015, the Board of Directors de- termined that the 2015 maximum bonus would be a maximum of 12 months’ fixed base salary plus pension contribution for the CEO, a maximum of eight-and-a-half months’ fixed base salary plus pension contribution forexecutives on international assignments and a maximum of eight months’ fixed base salary plus pension contribution forthe remaining members of Executive Management based inDenmark. SHARE-BASED INCENTIVES The long-term share-based incentive pro- gramme isdesigned topromotethecollective performance of ExecutiveManagement and align the interests of executives and share- holders.Share-based incentivesarelinked to both financial and non-financial targets.The long-termincentiveprogramme isbased ona calculation of economic value creationcom- paredwithplanned performance.Inlinewith NovoNordisk’slong-term financial targets, thecalculation ofeconomic value creationis based onreportedoperating profitaftertax, reduced by a weighted average cost of capital-based returnrequirementonaverage investedcapital. Toa largeextent,thesalesgrowth drivesthe financial development of the company and henceeconomicvaluecreation.Theeconomic value created can thus be adjusted in a negative directionif thesales performance is lower than budgeted sales. The calculated economicvaluecreationisfurtheradjusted if certain non-financial targets are not met. Non-financial targets aredetermined on the basis of an assessment of the objectives re- garded as particularly important for the fulfilment of the company’s long-term per- formance.Besidesfinancial and salesgrowth targets, the2015targets consistedof16tar- gets linkedtothecompany’s BalancedScore- card within the categories of researchand development, quality, patients, employees, environment and reputation. Targetswithin research and development were related to specific milestones, such as submission of product files to the regulatory authoritiesin theUSandEuropewithinacertaintimeframe, achievement of marketing authorisations,ex- ecution of trials and a defined number of product candidates to enter development fromdiscovery.Targetswithin quality related to recalls and warning letters, and targets withinenvironmentrelatedtotheemissionof CO 2 fromenergyconsumptionforproduction. Basedontheseprinciples,aproportionofthe calculated economic value creation is allo- catedtoajointpoolfortheparticipants, who include Executive Management and other membersoftheSeniorManagement Board. InMarch2015,theBoardofDirectorsdeter- mined thatthe2015maximum forExecutive Management asper1March2015wouldbe 12 months’ fixed base salary including pension contribution fortheCEOand up to nine months’ fixed base salary plus pension contribution fortheothermembers ofExec- utive Management . If the targets are met for economic value creation and sales growth, and at least 85% performance is reached for non-financial targets, the allo- cation tothejointpoolwould correspondto six months’ base salary plus pension contribution for the CEOand four-and-a- half months’ base salary plus pension con- tributionfortheothermembers ofExecutive Management . Furtherinformation on Novo Nordisk’sshare-based incentives isavailable atnovonordisk.com/about_us. REMUNERATION PACKAGECOMPONENTS Remuneration Board of Directors Executive Management Comments relating to Executive Management Fixed fee/base salary Accounts for approximately 25–50% of thetotal value of the remuneration package.* Fee for committeework Fee for ad hoctasks Cash-based incentive Up to eight-and-a-half months’ fixed base salary+ pension per year for executives on international assignments. Share-basedincentive 8–12months’ fixedbasesalary+pensionperyear for executives based inDenmark. 9–12 months’ fixed base salary incl pension per year.** Pensions 25% offixedbasesalaryand cash-based incentive. Travel allowance and otherexpenses Executive Management receives a minor travel allowance equaltothatofallotheremployees. Benefits Executive Management receives non-monetary benefits, such as company cars, phones, etc. Executives on international assignments may receive relocationbenefits. Severance payment Up to 24 months’ fixed base salary + pension. Three employment contracts entered into before 2008 exceed the 24-month limit, though will not exceed 36 months’ fixed base salary plus pension contribution. PENSION Pension contributions are paid to enable executives tobuild up an income forretire- ment. OTHER BENEFITS Other benefits are added to ensure that overall remuneration is competitive and aligned with localpractices. SEVERANCE PAYMENT NovoNordiskmay terminateemployment by giving executives 12 months’ notice. Exec- utives may terminate their employment by giving NovoNordisksix months’ notice. In addition tothe noticeperiod, executivesare entitledtoa severancepayment asdescribed in the overview of the composition of executive remuneration. Furtherinformation on Novo Nordisk severance payment is available atnovonordisk.com/about_us. 0 COMPOSITION OF EXECUTIVEREMUNERATION 2015 ON-TARGET PERFORMANCE Fixedbase salary Cashbonus Share-based incentive Pensions Benefits CEO 10 20 30 40 50 60 70 80 90 100% Other registered members of Executive Management * The interval 25–50% states the span between ‘maximum performance’ and ‘on-targetperformance’. **Executives as per 1 March 2015. NOVO NORDISK ANNUAL REPORT2015 50 GOVERNANCE, LEADERSHIP ANDSHARES
2014 REMUNERATION OF EXECUTIVE MANAGEMENT AND OTHER MEMBERS OF THE SENIOR MANAGEMENTBOARD 2015 Fixed Share- Fixed Share- DKKmillion base salary 5 Cash bonus Pension Bene?ts based incentive 6 Total base salary 5 Cash bonus Pension Bene?ts based incentive 6 Total ExecutiveManagement Lars RebienSørensen 10.6 10.6 5.3 0.3 – 26.8 10.4 9.5 5.0 0.3 – 25.2 JesperBrandgaard 6.0 4.0 2.5 0.3 – 12.8 5.8 3.9 2.5 0.3 – 12.5 Lars Fruergaard Jørgensen 5.2 3.5 2.2 0.3 – 11.2 4.4 2.2 1.6 0.3 – 8.5 Jakob Riis 5.2 2.8 2.0 0.3 – 10.3 4.4 1.8 1.5 0.3 – 8.0 Mads Krogsgaard Thomsen 6.0 4.0 2.5 0.3 – 12.8 5.8 3.9 2.5 0.3 – 12.5 Non-registered members of Executive Management 1,2 13.8 12.0 6.2 0.8 – 32.8 – – – – – – Retired membersof ExecutiveManagement: KåreSchultz 3 2.5 1.3 1.0 0.1 – 4.9 7.3 4.3 3.1 0.3 – 15.0 LiseKingo 3 – – – – – – 4.8 2.0 1.7 0.3 – 8.8 Share-based incentive – – – – 44.0 44.0 – – – – 27.3 27.3 Executive Management intotal 49.3 5 38.2 21.7 2.4 44.0 155.6 42.9 5 27.6 17.9 2.1 27.3 117.8 Other members of the Senior Management Board intotal 4 73.1 5 20.6 22.2 18.3 47.8 172.0 80.6 5 28.7 21.9 21.6 38.9 191.7 1.Effective 30 April2015,NovoNordisk’sExecutive Management was expanded toinclude four new members:Maziar Mike Doustdar, Jerzy Gruhn, Jesper Høiland and HenrikWulff, none ofwhom areregistered withtheDanishBusiness Authority asmembers ofExecutiveManagement ofNovoNordiskA/S.Respective amounts inthetable include remuneration for May toDecember 2015,with the exception of cash bonus, which coversthe full year.2.Amounts include taxespaid by NovoNordiskdue tothe members’ international employment terms.Inaddition, Maziar Mike Doustdar, Jerzy Gruhn and Jesper Høiland received bene?ts in 2015 in accordance with NovoNordisk’sInternational Assignment Guidelines, such as accommodation, children’s school fees, international health insurance and other types of insurance, spouse allowance and tax-?ling support, all offered net of tax tothe assignees. Including tax paid by Novo Nordisk, the bene?ts received in 2015 not included in the above table amount to DKK5.4 million. 3. Following a change in the distribution of responsibilities among themembers of ExecutiveManagement, Presidentand COOKåreSchultz left NovoNordiskasof April2015.Theremuneration of KåreSchultz up toApril 2015 isincluded in the above table, whereas severance payment, including participation in the share-based incentive programme for 2015 and part of 2016, of DKK72.7 million is not included.Theremuneration of LiseKingo for2014 isalsoincluded inthe above table, whereas severance payment, including participation inthe share-based incentive programme for 2015,of DKK32.2million isnotincluded.4.Thetotal remuneration for2015 includes remuneration of 34 Senior VicePresidents (31in2014),threeof whom have retiredorleft the company (nonein2014).The2015 remuneration fortheretiredSeniorVicePresidents isincluded inthetable above, whereas severance payments ofDKK26 millionarenot included. 5. Excluding social security taxes paid amounting to DKK1.3 million (DKK0.0 million in 2014) for Executive Management and DKK1.4 million (DKK2.7 million in 2014) for other members of the Senior Management Board.6.Thejoint pool of shares islocked up forthreeyears before itistransferred tothe participants employed at the end of the three-year period.Thevalue isthecash amount of thesharebonus granted intheyearusing thegrant-date market value of NovoNordiskBshares.During thelock-upperiod, thejointpoolmay potentially be reduced in the event of lower-than-planned value creation in subsequent years.Thesplit between Executive Management and other members isbased on the split of participants atthetimeoftheestablishment of thepool. MANAGEMENT’SLONG-TERMINCENTIVEPROGRAMME Thesharesallocated tothejointpoolfor2012(487,730shares)werereleasedtotheindividual participants subsequent totheapproval of theAnnual Report2015 bytheBoard of Directorsand theannouncement on3February 2016 of thefull-year ?nancial resultsfor 2015.Based onthesharepriceattheendof2015,thevalue ofthereleasedsharesisasfollows: Valueasat31December2015ofsharesreleasedon3February2016 Number ofshares Marketvalue 1 (DKKmillion) ExecutiveManagement Lars RebienSørensen 41,110 16.4 JesperBrandgaard 27,335 10.9 Lars Fruergaard Jørgensen 13,665 5.5 Jakob Riis 13,665 5.5 Mads Krogsgaard Thomsen 27,335 10.9 Non-registered members of Executive Management 2 40,995 16.4 Executive Management intotal 3 164,105 65.6 Other members of the Senior Management Board intotal 3 176,530 70.6 1. The market value of the shares released in February 2016 is based on the Novo NordiskB share price of DKK399.90 at the end of 2015.2. Including members of Executive Management notregistered with the Danish Business Authority.Inaddition, 4,000 shares werereleased toa non-registered member of Executive Management not part of the joint pool for 2012 for the Senior Management Board.3. In addition, 147,095 shares (market value: DKK58.8 million) were released to retired Executive Management and Senior Management Boardmembers. LarsRebien Sørensen servesasamember of theSupervisory Board of Bertelsmann AG,fromwhich hereceived remuneration of EUR31,897 until May 2015 (EUR117,000 in2014);as a board member of ThermoFisherScienti?c Inc, from which he received remuneration of USD223,865 until May 2015 (USD299,063 in 2014);and as a board member of Carlsberg A/S, fromwhich hereceivedremuneration ofDKK838,306 asofMarch 2015.Jesper Brandgaard servesaschairman oftheBoardofDirectorsofSimCorpA/S, fromwhich hereceived remuneration of DKK730,488 in 2015,including share-based payment forQ12015 (DKK913,500 in 2014,including share-based payment for the full year);and as chairman of the boardofNNITA/S, fromwhich hereceivedremuneration ofDKK562,500 asofMarch 2015 following theIPOofNNITA/S (DKK0in2014).Theremuneration receivedfromNNITA/S is part of the remuneration of ExecutiveManagement presented above.Mads Krogsgaard Thomsen servesasaboard member of the University of Copenhagen, from which hereceived remuneration of DKK81,606 in 2015 (DKK81,200 in 2014).Jakob Riisserves as a board member of ALK-Abelló A/S, from which he received remuneration of DKK415,000 in 2015 (DKK375,000 in2014).HenrikWulff servesasaboard member of AMBU A/S asof December2015 butdidnotreceiveremuneration in2015. GOVERNANCE, LEADERSHIP AND SHARES 51 2015 PERFORMANCE TRIGGERS MAXIMUM SHAREALLOCATION In2015, NovoNordiskexceededtheplanned targetforeconomicvaluecreationbymore thanthe10% incentivethreshold.Salesgrowthinlocal currencies was realised at 8.4%, thereby also exceeding the incentive target, while the threshold for the achievement of non-financial targets wasmet.Together,thismeansthatparticipantsintheshare-basedlong-termincentiveprogramme willreceive themaximum shareallocation.
BOARD OFDIRECTORS Name(male/female) Firstelected Term Nationality Born Independence 1 Göran Ando(m) 2005 2016 Swedish March1949 Notindependent 2 Jeppe Christiansen(m) 2013 2016 Danish November1959 Notindependent 2,4 Bruno Angelici(m) 2011 2016 French April1947 Independent Sylvie Grégoire(f) 2015 2016 Canadian/American November1961 Independent 4,5 Liz Hewitt(f) 2012 2016 British November1956 Independent 4,5 Liselotte Hyveled(f) 2014 2018 Danish January 1966 Notindependent 3 1.Asdesignated byNasdaqCopenhagen inaccordancewithsection3.2.1 ofRecommendations onCorporate Governance(updated 2014).2.Member ofManagement ortheBoardofNovoA/S. 3. Elected by employees ofNovo Nordisk. GÖRAN ANDO JEPPE CHRISTIANSEN BRUNO ANGELICI LISELOTTE HYVELED LIZ HEWITT SYLVIE GRÉGOIRE FormerlyCEOof CelltechGroupplc, UK(retired). Member of the Board of NovoNordiskA/S since 2005,vicechairsince2006,chairsince2013,chair oftheNominationCommitteesince2013and chair oftheRemuneration Committeesince2015. Management duties:Symphogen A/S, Denmark (chair), member of the boards of Novo A/S, Denmark, Molecular Partners AG, Switzerland, EUSA Pharma Ltd., UK, and ICMEC, US. Senior advisor toEssexWoodlands Health VenturesLtd., UK. Special competences : Medical qualifications and extensive executive background within the international pharmaceutical industry. Education:Specialism ingeneral medicine (1978) and degree in medicine (1973), both from Lin- köping Medical University,Sweden. Chief executive officer of Fondsmæglerselskabet Maj Invest A/S, Denmark.Member and vicechair of the Board of Novo Nordisk A/S since 2013. Member of the Remuneration Committee and AuditCommitteesince2015. Management duties: Haldor Topsøe A/S (vice chair),member oftheboards ofNovoA/S, KIRKBI A/S and Symphogen A/S, allinDenmark. Special competences:Extensivebackground and experiencewithin thefinancial sector,inparticular inrelationtofinancial and capital marketissues,as wellasinsight intotheinvestorperspective. Education: MSc in Economics (1985) from the UniversityofCopenhagen, Denmark. Formerlyexecutive vice president of AstraZeneca (retired). Member of the Board of NovoNordisk A/S since 2011 and member of the Nomination Committeesince2013. Management duties: Vectura Group plc (chair), member of the boards of Smiths Group plc, UK, and WoltersKluwer,the Netherlands.Member of theGlobalAdvisoryBoardofTakedaPharmaceutical Company Limited,Japan. Special competences:Extensiveglobal experience withtwocompanies inthefieldsofpharmaceuticals and medical devices, and in-depth knowledge of strategy,sales, marketing and governance ofmajor companies. Education: AMP (1993) from Harvard Business School and MBA (1978) from Kellogg School of Management at NorthwesternUniversity, both in theUS. FormerlyGroupDirectorCorporateAffairs ofSmith &Nephewplc,UK(retired).MemberoftheBoardof NovoNordiskA/S since 2012, chair of the Audit Committee since 2015 (member since 2012) and memberoftheNominationCommitteesince2013. Management duties:Member oftheboard and chair of the audit committee of Savills plc, and member oftheboardand chairofthenomination committee of Melrose Industries plc, both in the UK.Seniorexternalmember oftheaudit commit- teeoftheHouseofLords,UK. Special competences : Extensive experience within the field of medical devices, significant financial knowledge and knowledge ofhow large international companies operate. Education:BSc(Econ)(Hons)(1977)fromUniversity College London, UK, and FCA (UK Institute of CharteredAccountants) (1982). Projectvicepresident forNovoNordisk’smealtime insulin projects faster-acting insulin aspart and liver-preferential mealtime insulin in Global Development. Member of the Board of Novo Nordisk A/S since 2014 and member of the NominationCommitteesince2015. Education : Master of Science (1992) from Copenhagen University, and Master of Medical Business Strategies (2011) from Copenhagen Business School, both in Denmark. Formerlypresident of Human Genetic Therapies, Shireplc, USand Switzerland (retired).Member of the Board of Novo Nordisk A/S and the Audit Committeesince2015. Management duties: Member of the boards of Galenica AG, Switzerland and Perkin Elmer Inc., US.Chairman of the strategic committee of Tarix Orphan LLC., US. Advisor to the financial and biotechcommunity. Special competences : In-depth knowledge of the regulatory environment in both the US and the EU, having experience of all phases of the productlifecycle,including discovery,registration, pre-launch and managing the life cycle while on the market. In addition, she has financial insight fromi.a.P&Lresponsibility. Education: Pharmacy Doctorate degree (1986) fromtheState UniversityofNYatBuffalo, US,BA inPharmacy (1984)fromLaval University,Canada, and ScienceCollegedegree (1980)fromSéminaire deSherbrooke,Canada. NOVO NORDISK ANNUAL REPORT2015 52 GOVERNANCE, LEADERSHIP ANDSHARES
CEO of Novo A/S, Denmark. Member of the Board of NovoNordiskA/S and observeron the AuditCommitteesince2015. Management duties: Member of the boards of NNITA/SandtheSonionGroup,bothinDenmark. Special competences : Extensive executiveexpe- rience in large multinational companies head- quartered in Denmark within regulated markets, and significant financial knowledge. Education: AMP (1994) from Wharton Business School, US, and Master of Law (1983) from the UniversityofCopenhagen,Denmark. CEO of Aegerion Pharmaceuticals, Inc., US. Member of the Board of NovoNordiskA/S, the Remuneration Committee and the Nomination Committee since 2015.Member of the boards of Coherus Biosciences, Inc., Receptos Pharma- ceuticals, Inc.,Suneva Medical, Inc.and Aegerion Pharmaceuticals, Inc.,allintheUS. Management duties: Member of the boards of CoherusBiosciences,Inc.,ReceptosPharmaceuticals, Inc.and Suneva Medical Inc.,allintheUS. Special competences : In-depth understanding of the clinical, regulatory and marketing aspects of the pharmaceutical industry inNorthAmerica, having bothoperational and strategicexperience. Education: MBA (1991) from the University of Illinois at Chicago, US, and a BSc nursing degree (1985)fromtheUniversityofIllinoisatChicago,US. Name(male/female) Firstelected Term Nationality Born Independence 1 Thomas Paul Koestler(m) 2011 2016 American June1951 Independent Eivind Kolding(m) 2015 2016 Danish November1959 Notindependent 2 Anne Marie Kverneland(f) 2000 2018 Danish July1956 Notindependent 3 Søren Thuesen Pedersen(m) 2006 2018 Danish December1964 Notindependent 3 Stig Strøbæk(m) 1998 2018 Danish January 1964 Notindependent 3,4 Mary Szela (f) 2015 2016 American May1963 Independent 4.Pursuantto theUSSecuritiesExchange Act,MsHewittandMsGrégoirequalify asindependent AuditCommitteemembers whileMrChristiansenandMrStrøbæk rely onanexemption to the independence requirements. 5.MsHewittandMsGrégoirequalify asindependent AuditCommitteemembers asdefined underpart8oftheDanishActonApprovedAuditorsandAuditfirms. THOMAS PAUL KOESTLER SØREN THUESEN PEDERSEN ANNE MARIE KVERNELAND STIG STRØBÆK MARY SZELA EIVIND KOLDING Executive with Vatera Holdings LLC,US.Member oftheBoard ofNovoNordiskA/S since2011and member of the Remuneration Committee since 2015. Management duties: Melinta Therapeutics Inc., US (chair). Member of the boards of Momenta Pharmaceuticals Inc., ImmusanTInc., Arisaph Phar- maceuticals Inc. and Edgemont Pharmaceuticals LLC,allintheUS. Special competences:ExtensiveR&Dknowledge, both generally and within the field of regulatory affairs. Significant know-how about the pharma- ceutical industry in general and how large inter- national corporations operate. Additional knowl- edge oftheUSmarket. Education: PhD in Medicine & Pathology (1982) fromtheRoswellParkMemorialInstituteand BScin Biology(1975)fromDaemenCollege,bothintheUS. Electrician and union representative. Member of the Board of NovoNordiskA/S since 1998 and member oftheAuditCommitteesince2013. Education: Qualified electrician. Diploma in further training for board members (2003) from theDanishEmployees’ Capital Pension Fund (LD). External Affairs director in Quality Intelligence. Member of the Board of NovoNordiskA/S since 2006 andmemberoftheRemunerationCommittee since2015. Management duties: Member of the boards of HOFORA/S, HOFORForsyningHolding PS,HOFOR ForsyningKomplementarA/SandHOFORForsyning A/S(Copenhagen Utilities),allinDenmark. Education: BSc in Chemical Engineering (1988) fromtheEngineering Academy ofDenmark. Laboratory technician and union representative. Member of the Board of NovoNordiskA/S since 2000. Management duties: Member of the Novo NordiskFoundation since 2014. Education: Degree in Medical Laboratory Tech- nology (1980) from Copenhagen University Hospital, Denmark. NOVO NORDISK ANNUAL REPORT2015 GOVERNANCE, LEADERSHIP AND SHARES 53
EXECUTIVEMANAGEMENT LARS REBIEN SØRENSEN President and chief executive officer (CEO) Lars Rebien Sørensen joined NovoNordisk’s En- zymes Marketing in 1982. He was appointed president and chief executiveofficer inNovember 2000. Other management duties: Vice chair of the board ofCarlsberg A/S,Denmark. Born:October1954. Jesper Brandgaard joined NovoNordiskin 1999 as senior vicepresident of CorporateFinance.He was appointed executive vicepresident and chief financial officer inNovember2000. Other management duties:Chairoftheboards ofSimCorpA/S and NNITA/S, bothinDenmark. Born:October1963. JESPER BRANDGAARD Executive vice president and chief financial officer(CFO) Mads Krogsgaard Thomsen joined NovoNordisk in 1991 as head of Growth Hormone Research. He was appointed senior vice president of DiabetesR&Din1994 and executivevicepresident and chief scienceofficer inNovember2000. Other management duties: Chairof the board ofStenoDiabetesCenterA/S and vicechairofthe board of the Universityof Copenhagen, both in Denmark. Born:December1960. MADS KROGSGAARD THOMSEN Executive vice president, chief science officer (CSO) LARS FRUERGAARD JØRGENSEN Executive vicepresident andchiefofstaff Jakob RiisjoinedNovoNordiskin1996 asa health economist in Marketing. Hewas appointed senior vice president for Marketing in 2005. In January 2013, he was appointed executive vice president and in2015hetookoverresponsibilityforsales in theChinaandPacificregions. Other management duties: Chairof the board ofCopenhagen InstituteofInteractionDesign and member of the board and chair of the audit committeeofALK-AbellóA/S, bothinDenmark. Born:April1966. JAKOB RIIS Executive vice president, China, Pacific & Marketing LarsFruergaard Jørgensen joined NovoNordiskin 1991asaneconomist.Hewasappointed executive vice president for IT,Quality & CorporateDevel- opmentinJanuary 2013,andinNovember2014he tookoverthe responsibilitiesforCorporatePeople &OrganisationandBusinessAssurance. Other management duties:Chairoftheboardof NNEPharmaplan A/S,Denmark. Born:November1966. Henrik Wulff joined NovoNordiskin 1998 as a chemist. Hewas appointed senior vice president of Product Supply in 2013, and in April 2015 he was appointed executivevicepresident ofProduct Supply. Other management duties: Chairof the board ofNNPharmatech A/Sand member oftheboards of NNEPharmaplan A/S and Ambu A/S, all in Denmark. Born:November1970. HENRIK WULFF Executive vice president, Product Supply Jesper Høiland joined NovoNordisk in 1987 as assistant area manager for the US, Canada, Australia and New Zealand. He was appointed senior vice president of NorthAmerica in 2013, and inApril2015hewas appointed executivevice president with responsibility fortheUS. Born:September 1960. JESPER HØILAND Executivevice president,US Jerzy Gruhn joined Novo Nordisk in 1996 as NationalSalesManager inPoland.Hewasappoint- edseniorvicepresident ofEuropein2013,and in April2015 he was appointed executivevicepresi- dent withresponsibilityforEurope. Born:June 1963. JERZY GRUHN Executive vice president, Europe Maziar Mike Doustdar joined Novo Nordisk in 1992 asan office clerkinVienna, Austria.Hewas appointed senior vice president of International Operations in 2013, and in April 2015 he was appointed executive vice president with respon- sibilityforInternational Operations. Born:August 1970. MAZIAR MIKE DOUSTDAR * Executivevice president, International Operations * Not registered with the Danish Business Authority as member of Executive Management of Novo NordiskA/S. NOVO NORDISK ANNUAL REPORT2015 54 GOVERNANCE, LEADERSHIP ANDSHARES
NovoNordiskremains committed toreportits performance through its integrated reporting. In line with the Novo Nordisk Triple Bottom Line principle, the Consolidated financial, social and environmental statements are presented along withtherelatednotes. Within each of the financial, social and environmental statements, the notes are grouped into sections based on how NovoNordiskviews itsbusiness. Each of the sections has an introduction explaining the link between long-term targets and business priorities, and how this isreflected inNovoNordisk’sfinancial, social and environmental statements.Toprovidetransparency inthe disclosed amounts, each note includes the relevant accounting policy, key accounting estimates and numerical disclosure. CONSOLIDATED FINANCIAL, SOCIAL AND ENVIRONMENTAL STATEMENTS2015 56 Income statement andStatement of comprehensive income 57 Balancesheet 58 Statement of cash flows 59 Statement of changes inequity 60 Notes to the Consolidated financial statements CONSOLIDATED FINANCIAL STATEMENTS 96 Statement of socialperformance 97 Notes to the Consolidated socialstatement CONSOLIDATED SOCIALSTATEMENT (SUPPLEMENTARYINFORMATION) 102 Statement of environmental performance 102 Notes to theConsolidated environmentalstatement CONSOLIDATED ENVIRONMENTAL STATEMENT (SUPPLEMENTARYINFORMATION) Novo Nordisk Headquarters, in Bagsværd north of Copenhagen in Denmark, designed by Henning LarsenArchitects. NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 55
NOVO NORDISK ANNUAL REPORT2015 56 CONSOLIDATED FINANCIALSTATEMENTS INCOMESTATEMENT AND STATEMENT OF COMPREHENSIVE INCOME FOR THE YEAR ENDED 31DECEMBER DKKmillion Note 2015 2014 2013 INCOMESTATEMENT Netsales 2.1, 2.2 107,927 88,806 83,572 Cost of goodssold 2.2 16,188 14,562 14,140 Grossprofit 91,739 74,244 69,432 Sales and distributioncosts 2.2 28,312 23,223 23,380 Research and development costs 2.2, 2.3 13,608 13,762 11,733 Administrative costs 2.2 3,857 3,537 3,508 Other operating income, net 2.2, 2.5 3,482 770 682 –Non-recurring income from the partial divestment of NNIT A/S 2.5 2,376 – – Operatingprofit 49,444 34,492 31,493 Financial income 4.9 85 167 1,702 Financial expenses 4.9 6,046 563 656 Profit before incometaxes 43,483 34,096 32,539 Incometaxes 2.6 8,623 7,615 7,355 Net profit for theyear 34,860 26,481 25,184 EARNINGS PERSHARE Basic earnings per share(DKK) 4.1 13.56 10.10 9.40 Diluted earnings per share(DKK) 4.1 13.52 10.07 9.35 ) ) ) ) DKKmillion Note 2015 2014 2013 STATEMENT OF COMPREHENSIVE INCOME Net profit for theyear 34,860 26,481 25,184 Other comprehensive income: Exchange rate adjustments of investments insubsidiaries (669) (39) (435 Cash flow hedges, realisation of previously deferred (gains)/losses 4.3 2,216 (1,229) (809 Cash flow hedges, deferred gains/(losses) incurred during the period 4.3 (681) (2,225) 1,195 Otheritems 366 111 75 Items that will be reclassified subsequently to the Income statement when specific conditions aremet 1,232 (3,382) 26 Remeasurements of defined benefit plans 3.5 (37) (247) 54 Items that will not subsequently be reclassified to the Income statement (37) (247) 54 Other comprehensive income beforetax 1,195 (3,629) 80 Tax on other comprehensive income, income/(expense) 2.6 (87) 977 (211 Other comprehensive income for the year, net oftax 1,108 (2,652) (131 Total comprehensive income for theyear 35,968 23,829 25,053
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 57 BALANCESHEET AT 31DECEMBER DKKmillion Note 2015 2014 ASSETS Intangible assets 3.1 2,158 1,378 Property, plant and equipment 3.2 25,545 23,136 Investment in associated company 4.8 811 – Deferred income taxassets 2.6 6,806 5,399 Other financial assets 4.7 1,339 856 Total non-currentassets 36,659 30,769 Inventories 3.3 12,758 11,357 Tradereceivables 3.4 15,485 13,041 Taxreceivables 3,871 3,210 Other receivables and prepayments 4.7 2,257 2,750 Marketable securities 4.2, 4.4, 4.7 3,542 1,509 Derivative financial instruments 4.2, 4.3, 4.7 304 30 Cash at bank and onhand 4.2, 4.4 16,923 14,396 Total currentassets 55,140 46,293 Totalassets 91,799 77,062 EQUITY ANDLIABILITIES ) ) Sharecapital 4.1 520 530 Treasuryshares 4.1 (10) (11 Retained earnings 46,816 41,277 Otherreserves (357) (1,502 Totalequity 46,969 40,294 Deferred income taxliabilities 2.6 6 7 Retirement benefit obligations 3.5 1,186 1,031 Provisions 3.6 2,765 2,041 Total non-currentliabilities 3,957 3,079 Currentdebt 4.4, 4.7 1,073 720 Tradepayables 4.7 4,927 4,950 Taxpayables 3,777 2,771 Otherliabilities 3.7,4.7 12,655 11,051 Derivative financial instruments 4.2, 4.3, 4.7 1,382 2,607 Provisions 3.6 17,059 11,590 Total currentliabilities 40,873 33,689 Totalliabilities 44,830 36,768 Total equity andliabilities 91,799 77,062
NOVO NORDISK ANNUAL REPORT2015 58 CONSOLIDATED FINANCIALSTATEMENTS STATEMENT OF CASHFLOWS FOR THE YEAR ENDED 31DECEMBER DKKmillion Note 2015 2014 2013 Netprofit fortheyear 34,860 26,481 25,184 Adjustment for non-cash items: Income taxes in Incomestatement 2.6 8,623 7,615 7,355 Depreciation, amortisation and impairment losses Non-recurring income from the partial divestment of NNIT A/S included in ‘other operatingincome’ 3.1,3.2 2.5 2,959 (2,526) 3,435 – 2,799 – Other non-cashitems 4.6 5,908 4,163 584 Change in working capital 4.5 (2,157) (2,148) (265) Interestreceived 55 131 131 Interestpaid (61) (78) (39) Income taxespaid 2.6 (9,374) (7,907) (9,807) Netcashgenerated from operating activities 38,287 31,692 25,942 Proceeds from the partial divestment of NNITA/S 2.5 2,303 – – Purchase of intangible assets 3.1 (1,182) (321) (403) Proceeds from sale of property, plant andequipment 15 4 31 Purchase of property, plant andequipment 3.2 (5,224) (3,990) (3,238) Proceeds from sale of other financial assets 32 35 29 Purchase of other financial assets (9) (24) (3) Sale of marketable securities 1,500 2,232 811 Purchase of marketable securities (3,533) – – Netcashusedininvesting activities (6,098) (2,064) (2,773) Purchase of treasury shares,net 4.1 (17,196) (14,667) (13,924) Dividendspaid 4.1 (12,905) (11,866) (9,715) Netcashusedinfinancing activities (30,101) (26,533) (23,639) Netcashgenerated from activities 2,088 3,095 (470) Cash and cash equivalents at the beginning of theyear 13,676 10,513 11,053 Exchange gains/(losses) on cash and cash equivalents 86 68 (70) Cashandcashequivalents attheendoftheyear 4.4 15,850 13,676 10,513
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 59 STATEMENT OF CHANGES INEQUITY AT 31DECEMBER Otherreserves Exchange rate Cash Taxand Total DKKmillion Share capital Treasury shares Retained earnings adjust- ments flow hedges other items other reserves Total 2015 Balance at the beginning of theyear 530 (11) 41,277 (248) (2,221) 967 (1,502) 40,294 Net profit for theyear 34,860 34,860 Other comprehensive income for theyear (37) (669) 1,535 279 1,145 1,108 Total comprehensive income for the year 34,823 (669) 1,535 279 1,145 35,968 Transactions withowners: Dividends (note4.1) (12,905) (12,905) Share-based payments (note5.1) 442 442 Tax credit related to restricted stockunits (note2.6) 366 366 Purchase of treasury shares (note4.1) (10) (17,219) (17,229) Sale of treasury shares (note4.1) 1 32 33 Reduction of the B share capital (note4.1) (10) 10 – Balanceattheendoftheyear 520 (10) 46,816 (917) (686) 1,246 (357) 46,969 2014 Balance at the beginning of theyear 550 (21) 41,137 (209) 1,233 (121) 903 42,569 Net profit for theyear 26,481 26,481 Other comprehensive income for theyear (247) (39) (3,454) 1,088 (2,405) (2,652) Total comprehensive income for the year 26,234 (39) (3,454) 1,088 (2,405) 23,829 Transactions withowners: Dividends (note4.1) (11,866) (11,866) Share-based payments (note5.1) Tax credit related to restricted stockunits (note2.6) 371 58 371 58 Purchase of treasury shares (note4.1) (11) (14,717) (14,728) Sale of treasury shares (note4.1) 1 60 61 Reduction of the B share capital (note4.1) (20) 20 – Balance at the end ofthe year 530 (11) 41,277 (248) (2,221) 967 (1,502) 40,294 2013 Balance at the beginning of theyear 560 (17) 39,001 226 847 15 1,088 40,632 Net profit for theyear 25,184 25,184 Other comprehensive income for theyear 54 (435) 386 (136) (185) (131) Total comprehensive income for the year 25,238 (435) 386 (136) (185) 25,053 Transactions withowners: Dividends (note4.1) (9,715) (9,715) Share-based payments (note5.1) Tax credit related to restricted stock units (note2.6) 409 114 409 114 Purchase of treasury shares (note4.1) (15) (13,974) (13,989) Sale of treasury shares (note4.1) 1 64 65 Reduction of the B share capital (note4.1) (10) 10 – Balance at the end ofthe year 550 (21) 41,137 (209) 1,233 (121) 903 42,569
NOVO NORDISK ANNUAL REPORT2015 SECTION 1 BASIS OFPREPARATION Read this section to get an overview of the financial accounting policies in general and an overview of Management’s key accounting estimates. 1. Principal accounting policies and key accounting estimates, p 61 2. Changes in accounting policies and disclosures, p 62 3. General accounting policies, p62 SECTION 2 RESULTS FOR THEYEAR Read this section to get more details on the results for the year, including operating segments, taxes and employee costs. 1. Net sales and sales deductions, p63 2. Segment information, p65 3. Research and development costs, p68 4. Employee costs, p69 5. Other operating income, net, p69 6. Income taxes and deferred income taxes, p70 SECTION 3 OPERATING ASSETS AND LIABILITIES Read this section to get more details on the assets that form the basis for the activities of Novo Nordisk, and the related liabilities. 1. Intangible assets, p72 2. Property, plant and equipment, p73 3. Inventories, p75 4. Trade receivables, p75 5. Retirement benefit obligations, p76 6. Provisions and contingent liabilities, p 77 7. Other liabilities, p78 SECTION 4 CAPITAL STRUCTURE AND FINANCINGITEMS Read this section to gain an insight into the capital structure, cash flow and financing items. 1. Share capital, distribution to shareholders and earnings per share, p79 2. Financial risks, p81 3. Derivative financial instruments, p82 4. Cash and cash equivalents, financial resources and free cash flow, p84 5. Change in working capital, p84 6. Other non-cash items, p85 7. Financial assets and liabilities, p85 8. Investment in associated company, p87 9. Financial income and expenses, p87 SECTION 5 OTHERDISCLOSURES Read this section for more details on the statutory notes that have secondary importance from the perspective of NovoNordisk. 1. Share-based payment schemes, p88 2. Management’s holdings ofNovoNordiskshares,p90 3. Commitments, p91 4. Related party transactions, p92 5. Fee to statutory auditors, p92 6. Companies in the Novo Nordisk Group, p93 7. Financial definitions, p94 60 CONSOLIDATED FINANCIALSTATEMENTS NOTES SECTIONS IN THE CONSOLIDATED FINANCIALSTATEMENTS Basis ofpreparation Results for theyear Operatingassets andliabilities Capital structure and ?nancingitems Otherdisclosures
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 61 SECTION 1 BASIS OFPREPARATION NovoNordiskpresents itsConsolidated financial statements on the basis of the latest developments in international financial reporting and strives for early adoption of EU-endorsed IFRSaccounting standards.Allentities in the NovoNordiskGroupfollow thesame Groupaccounting policies.Thissection gives a summary of thesignificant accounting policies, Management’s key accounting estimates, new IFRSrequirements and other accounting policies in general.Adetailed description of accounting policies and key accounting estimates related tospecific reportedamounts ispresented in each note to therelevantfinancial items. 1.1 PRINCIPAL ACCOUNTING POLICIES AND KEY ACCOUNTINGESTIMATES TheConsolidated financial statements included inthisAnnual Report have been prepared in accordance with International Financial Reporting Standards (IFRS)as issued by the International Accounting Standards Board (IASB),inaccordance with IFRSasendorsed bytheEuropean Unionand also in accordance with additional Danish disclosure requirements for annual reportsoflistedcompanies. Measurementbasis TheConsolidated financial statements have been prepared on the historical cost basis except for derivative financial instruments, associated company, equityinvestments and marketable securitiesmeasured atfair value. The principal accounting policies set out below have been applied consistently in the preparation of the Consolidated financial statements for alltheyearspresented. Principalaccountingpolicies NovoNordisk’saccounting policies are described in each of the individual notes to the Consolidated financial statements. Considering all the accounting policies applied, Management regards the ones listed in the table below as the most significant accounting policies for the recognition and measurement ofreportedamounts. Keyaccountingestimatesandjudgements Theuse of reasonable estimates and judgements isan essential part of the preparation oftheConsolidated financial statements.Giventheuncertainties inherent in Novo Nordisk’s business activities, Management must make certain estimates and judgements that affect the application of accounting policies and reported amounts of assets, liabilities, sales, costs, cash flows and related disclosures at the date(s) of the Consolidated financial statements.Theestimates identified arethose that have a significant riskof resulting ina materialadjustment. Management bases its estimates on historical experience and various otherassumptions that are held tobe reasonable under the circumstances. The estimates and underlying assumptions are reviewed on an ongoing basis and, if necessary, changes are recognised in the period in which the estimate isrevised.Management considers the carrying amounts recognised in relation to the key accounting estimates mentioned below to be reasonable and appropriate based on currently available information . However, the actual amounts may differ from the amounts estimated as moredetailed information becomes available. Management regards those listedbelow tobe the keyaccounting estimates and judgements used in the preparation of the Consolidated financial statements. Please refer to the specific notes for further information on the key accounting estimates and judgements as well as assumptions applied. Principal accountingpolicies Key accounting estimates andjudgements Note Net sales and salesdeductions Sales deductions –estimate of unsettled obligations 2.1 Research and development – 2.3, 3.1and 3.2 Derivative financial instruments – 4.3 Income taxes and deferred incometaxes Provision for uncertain tax positions, accrual for income taxes and deferred tax assets and liabilities 2.6 Property, plant and equipment including impairment – 3.2 Inventories Indirect production costscapitalised 3.3 Tradereceivables Allowance for doubtful trade receivables 3.4 Provisions and contingent liabilities Provisions for sales rebates and ongoing legal disputes 3.6 Applyingmateriality The Consolidated financial statements are a result of processing large numbers of transactions and aggregating those transactions into classes according totheirnature orfunction.Whenaggregated, thetransactions are presented inclasses ofsimilaritemsintheConsolidated financial statements. If a line item is not individually material, it is aggregated with other items ofa similarnature intheConsolidated financial statements orinthenotes. Therearesubstantial disclosure requirements throughout IFRS.Management provides specific disclosures required by IFRS unless the information is consideredimmaterial totheeconomic decision-making oftheusersofthese financial statements ornot applicable. Basis ofpreparation Results for theyear Operatingassets andliabilities Capital structure and ?nancingitems Otherdisclosures
NOVO NORDISK ANNUAL REPORT2015 62 CONSOLIDATEDFINANCIALSTATEMENTS 1.2 CHANGES IN ACCOUNTING POLICIES ANDDISCLOSURES AdoptionofneworamendedIFRSs Basedonanassessmentof new oramendedandrevisedaccounting standardsandinterpretations(‘IFRSs’)issuedbyIASB,andIFRSsendorsed bytheEuropeanUnioneffectiveonorafter1January2015,ithasbeen assessedthattheapplicationofthesenewIFRSshasnothadamaterial impactontheConsolidatedfinancialstatementsin2015,andManagement doesnotanticipateanysignificantimpactonfutureperiodsfromthe adoptionofthesenewIFRSs. New or amended IFRSs that have been issued but have not yet come into effect and have not been earlyadopted Inadditiontotheabove,IASBhasissuedanumberofneworamendedand revisedaccountingstandardsandinterpretationsthathavenotyetcomeinto effect.Thefollowingstandardsareingeneralexpectedtochangecurrent accountingregulationmostsignificantly: •IASBhasissuedIFRS9‘FinancialInstruments’,witheffectivedate1January 2018.ItcurrentlyawaitsEUendorsement.IFRS9ispartoftheIASB’s projecttoreplaceIAS39,andthenewstandardwillsubstantiallychange theclassificationandmeasurementoffinancialinstrumentsandhedging requirements.NovoNordiskhasassessedtheimpactofthestandardand determinedthatitwillnothaveanysignificantimpactontheConsolidated financialstatements. •IASBhasissuedIFRS15‘Revenuefromcontractswithcustomers’,with effectivedate1January2018.ItcurrentlyawaitsEUendorsement.IFRS15 ispartoftheconvergenceprojectwithFASBtoreplaceIAS18.Thenew standardwillestablishasingle,comprehensiveframeworkforrevenue recognition.NovoNordiskhascompletedapreliminaryassessmentofthe impactofthestandardandjudgedthatitwillnothaveanysignificant impactontheConsolidatedfinancialstatements. •IASBhasissuedIFRS16‘Leasing’witheffectivedate1January2019. The changeinleaseaccountingrequirescapitalisationofthemajorityof the Group’soperationalleasecontracts,representingupto10% of total assets,which will havean impacton the Group’sassets,and a correspondingimpactontheliabilities.Hencethiswillaffectthefinancial ratiosrelatedtothebalancesheet.Thechangewillhaveaminorimpacton netprofitasIFRS16requirestheleasepaymentstobesplitbetweena depreciationchargeincludedinoperatingcostsandaninterestexpenseon leaseliabilitiesincludedinfinancecosts. 1.3GENERALACCOUNTINGPOLICIES Principlesofconsolidation TheConsolidatedfinancialstatementsincorporatethefinancialstatements ofNovoNordiskA/SandentitiescontrolledbyNovoNordiskA/S.Control existswhenNovoNordiskhaseffectivepowerovertheentityandhasthe righttovariablereturnsfromtheentity. Wherenecessary,adjustmentsaremadetothefinancialstatementsof subsidiariestobringtheiraccountingpoliciesinlinewithNovoNordisk Grouppolicies.Allintra-Grouptransactions,balances,incomeandexpenses areeliminatedinfullwhenconsolidated. Theresultsofsubsidiariesacquiredordisposedofduringtheyearare includedintheconsolidatedincomestatementfromtheeffectivedate of acquisitionandup to theeffectivedateof disposal,as appropriate. Comparativefiguresarenotrestatedfordisposedoracquiredcompanies. Translationofforeigncurrencies Functionalandpresentationcurrency ItemsincludedinthefinancialstatementsofeachofNovoNordisk’sentities aremeasuredusingthecurrencyoftheprimaryeconomicenvironmentin whichtheentityoperates(functionalcurrency).TheConsolidatedfinancial statementsarepresentedinDanishkroner(DKK),whichisalsothefunctional andpresentationcurrencyoftheparentcompany. Translationoftransactionsandbalances Foreigncurrencytransactionsaretranslatedintothefunctionalcurrency usingtheexchangeratesprevailingat thetransactiondates. Foreign exchangegainsandlossesresultingfromthesettlementofsuchtransactions andfromthetranslationatyear-endexchangeratesofmonetaryassetsand liabilitiesdenominatedinforeigncurrenciesarerecognisedintheIncome statement. Translationdifferencesonnon-monetaryitems,suchasequityinvestments classifiedasfinancialassetsavailableforsale,arerecognisedinOther comprehensiveincome. TranslationofGroupcompanies FinancialstatementsofforeignsubsidiariesaretranslatedintoDanishkroner attheexchangeratesprevailingattheendofthereportingperiodfor balancesheetitems,andataverageexchangeratesforincomestatement items. AlleffectsofexchangerateadjustmentsarerecognisedintheIncome statement,withtheexceptionofexchangerateadjustmentsofinvestments insubsidiariesarisingfrom: •thetranslationofforeignsubsidiaries’netassetsatthebeginningofthe yeartotheexchangeratesattheendofthereportingperiod •thetranslationofforeignsubsidiaries’statementsofcomprehensiveincome fromaverageexchangeratestotheexchangeratesattheendofthe reportingperiod •thetranslationofnon-currentintra-Groupreceivablesthatareconsidered tobeanadditiontonetinvestmentsinsubsidiaries. These specific exchange rate adjustments are recognised in Other com- prehensiveincome.
NOVO NORDISK ANNUAL REPORT2015 107.9 (+22%) DKKBILLION IN NETSALES 34.9 (+32%) DKK BILLION IN NETPROFIT CURRENCY IMPACT ONGROWTH Growthlocalcurrencies GrowthDKK Share of growth regardingNNIT divestment % 50 40 30 20 10 0 2014 2015 2014 2015 Netsales Operatingpro?t 0 10 20 30 40 50 % 2014 Netsales Operatingpro?t 2015 20152014 CURRENCY IMPACT ONGROWTH Q Growth local currencies QGrowth DKK Q Share ofgrowth regarding NNIT A/S divestment 107.9 DKK BILLION IN NET SALES (+22%) 49.4 DKK BILLION IN OPERATING PROFIT (+43%) Thissectioncomprisesnotesrelatedtotheresultsfortheyear,suchassales includingdetailsongross-to-netsalesandsegmentinformation,research anddevelopmentcosts,employeecostsaswellasdetailsonincomeand deferredincometaxes. Consequently,thissectionprovidesinformation relatedtoNovoNordisk’slong-termfinancialtargetforgrowthinoperating profit. NovoNordisk’sgrowthinsalesisaresultofcontinuedgrowthinthenumber ofpatientsduetothediabetespandemic,NovoNordisk’sabilitytobring innovativeproductstothemarketandtheglobalcommercialpresenceof ourbusiness. Thegrowthinoperatingprofitandmarginreflectsnotonlygrowthinsales, butalsocurrencyimpactandtheincreaseingrossmarginprimarilydrivenby a positiveproductmixduetoincreasedsalesof Victoza ® andmodern insulins.Further,non-recurringincomefromthedivestmentofNNITA/Shas affectedoperatingprofitpositively.Therehasbeenadecreaseinresearch anddevelopmentcostsreflectingthediscontinuationofactivitieswithin inflammatorydisordersin2014. The article ‘2015 performance and 2016 outlook’ on p 6 includes Manage- ment’s review of the results for theyear. Currencyfluctuationsimpactreportedsalesgrowth Currencyfluctuationshavea directimpactonreportedNetsalesand reportedOperatingprofit,thoughimpactonNetprofitislimited.In2015, thecurrencyimpactongrowthinNetsalesandOperatingprofitisan increaseof13%pointand23%pointrespectively(2%pointand3% point decreasein2014),comparedwithgrowthinlocalcurrencies.Theimpactof currencyfluctuationsinthekeycurrencies(USD,JPY,CNY,GBPandCAD)is mitigatedthroughhedgingcontracts,whichareincludedinFinancialincome andexpenses.Hence,reportedNetprofitisimpactedonlytoalimiteddegree bykeycurrencyfluctuations. However,hedgingis not consideredfeasiblefor emerging-market currencies.Consequently,suchcurrencyfluctuationshaveadirectimpact onbothreportedNetsalesandNetprofit. Notes4.2and4.3includeinformationontheforeignexchangeriskanda sensitivityanalysisforthekeycurrencies. CONSOLIDATED FINANCIAL STATEMENTS 63 SECTION 2 RESULTS FOR THEYEAR 2.1NETSALESANDSALESDEDUCTIONS Accountingpolicies RevenuefromgoodssoldisrecognisedwhenNovoNordiskhastransferred thesignificantrisksandrewardstothebuyer,theGroupnolongerhas managerialinvolvement,andtheamountofrevenuecanbemeasured reliably. Salesaremeasuredatthefairvalueoftheconsiderationreceivedorreceiv- able.Whensalesarerecognised,NovoNordiskalsorecordsestimatesfor a varietyofsalesdeductions,includingproductreturnsaswellasrebatesand discountsto governmentagencies, wholesalers,health insurance companies,managedhealthcareorganisationsandretailcustomers.Sales deductionsarerecognisedasareductionofgrosssalestoarriveatnetsales. Wherecontractscontaincustomeracceptanceprovisions,NovoNordisk recognisessaleswhentheacceptancecriteriaaresatisfied. Revenuerecognitionfornewproductlaunchesisbasedonspecificfacts andcircumstancesrelatingtothoseproducts,includingestimateddemand andacceptanceratesforwell-establishedproductswithsimilarmarket characteristics.Whereshipmentsofnewproductsaremadeonasaleor returnbasis,withoutsufficienthistoricalexperienceforestimatingsales returns,revenueisonlyrecordedwhenthereisevidenceofconsumptionor whentherightofreturnhasexpired. Key accounting estimates –Salesdeductions Salesdeductionsareestimatedandprovidedforatthetimetherelated salesarerecorded.Theseestimatesofunsettledobligationsrequireuseof judgement,asallconditionsarenotknownatthetimeofsale,forexample totalsalesvolumetoagivencustomer.Provisionsforsalesrebatesare adjustedtoactualamountsasrebatesanddiscountsareprocessed. Basis ofpreparation Results for theyear Operatingassets andliabilities Capital structure and ?nancingitems Otherdisclosures
NOVO NORDISK ANNUAL REPORT2015 64 CONSOLIDATEDFINANCIALSTATEMENTS 2.1 NET SALES AND SALES DEDUCTIONS (CONTINUED) Sales discounts and sales rebates are predominantly issued in Region North America. In addition, political pressure to contain healthcare costs has led several other countries to impose significant price reductions on pharma- ceutical products.Assuch, governments in countries in Region Europe have implemented concerted austerity measures, while government-mandated pricecutshave been introduced inRegion China, Japan and major countries inRegion International Operations. In the US, significant sales rebates are paid in connection with public healthcare insurance programmes, namely Medicare and Medicaid, as well as rebates to pharmacy benefit managers (PBMs) and managed healthcare plans. Key customers in the US include private payers, PBMs and government payers. Increasingly, PBMs play a key rolein negotiating price concessions withdrug manufacturers onbehalf ofprivatepayersforboththecommercial and government channels, and determining the listof drugs covered in the HealthPlan’sformulary.Specifically, therearetwoprimarydrivers: • Payer pressure to reduce the overall drug costs has resulted in greater focus on negotiating higher rebates from drug manufacturers . Private payers are increasingly keen to adopt narrow formularies that exclude certaindrugs, while securing higher rebatesfromthepreferredbrand. • Recent industry consolidation among private payers and PBMs has led to increasing pricing pressure for pharmaceutical companies. USManagedCareandMedicare For Managed Care and Medicare, rebates are offered to a number of PBMs and managed healthcare plans. These rebate programmes allow the customer to receive a rebate after attaining certain performance parameters relating to formulary status or pre-established market shares relativetocompetitors.Rebates areestimated according tothespecific terms in each agreement, historical experience, anticipated channel mix, growth rates and market share information . Novo Nordisk adjusts the provision periodically toreflectactual sales performance. USwholesaler charge-backs Wholesaler charge-backs relate tocontractual arrangements between Novo Nordisk and indirect customers in the US whereby products are sold at contract prices lowerthan the listpriceoriginally charged towholesalers.A wholesaler charge-back represents the difference between the invoice price to the wholesaler and the indirect customer’s contract price. Accruals are calculated forestimated charge-backs using acombination offactors such as historical experience, currentwholesaler inventory levels, contract termsand the value of claims receivedbut notyetprocessed.Wholesaler charge-backs aregenerally settledwithin 30 days oftheliability being incurred. USMedicaid Medicaid isa government insurance programme, and Medicaid rebates have been calculated using a combination of historical experience, product and population growth, priceincreases, and theimpact of contracting strategies. Further,thecalculation involvesinterpretation ofrelevantregulations thatare subject tochanges in interpretative guidance from government authorities. Although provisions are made for Medicaid rebates at the time sales are recorded, the actual rebates related to the specific sale will typically be invoiced toNovoNordisk6–9months later.Duetothetimelag, therebate adjustments tosales inany particular periodmay incorporate adjustments of provisionsfrompriorperiods. Discounts,salesreturnsandother rebates Otherdiscounts areprovided towholesalers, hospitals, pharmacies etc, and are usually linked to sales volume orprovided as cash discounts. Accruals arecalculated based onhistorical data, and recordedas a reductioningross sales at the time the related sales are recorded.Sales returnsare related to damaged orexpiredproducts. Arrangements withcertainhealthcare providersmay requireNovoNordiskto make refunds tothe healthcare providersif anticipated treatment outcomes donotmeetpredefined targets. GROSS-TO-NET SALESRECONCILIATION DKKmillion 2015 2014 2013 Grosssales 182,779 131,841 115,906 US Managed Care and Medicare (33,235) (17,522) (12,504) US wholesaler charge-backs (22,030) (12,858) (10,126) US Medicaid rebates (9,838) (5,578) (3,851) Other US discounts and salesreturns Non-US rebates, discounts and salesreturns (4,685) (5,064) (2,972) (4,105) (2,063) (3,790) Total gross-to-net sales adjustments (74,852) (43,035) (32,334) Netsales 107,927 88,806 83,572 Please refer to note 3.6 for further information on sales-related provisions.
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 65 Segmentperformanceisevaluatedonthebasisofoperatingprofitconsistent withtheConsolidatedfinancialstatements.Financialincomeandexpenses andincometaxesaremanagedatGrouplevelandarenotallocatedto businesssegments. Further,non-recurringincomefrom the partial divestmentofNNITA/Shasnotbeenallocatedtosegments. Therearenosalesorothertransactionsbetweenthebusinesssegments. Costshavebeensplitbetweenbusinesssegmentsaccordingtoaspecific allocationwiththeadditionofaminornumberofcorporateoverhead costsallocatedsystematicallybetweenthesegments. Otheroperating incomehasbeenallocatedtothetwosegmentsbasedonthesameprinciple. Segmentassetscomprisetheassetsthatareapplieddirectlytotheactivities ofthesegment,includingintangibleassets,property,plantandequipment, otherfinancialassets,inventories,tradereceivables,andotherreceivables andprepayments. No operating segments have been aggregated to form the reported business segments. 2.2 SEGMENTINFORMATION Accountingpolicies Operating segments are reported in a manner consistent with the internal reporting provided to Executive Management and the Board ofDirectors. WeconsiderExecutiveManagementtobetheoperatingdecision-making bodyasallsignificantdecisionsregardingbusinessdevelopmentanddirection aretakeninthatforum. Businesssegments Novo Nordisk operates in two business segments based on therapies: Diabetes and obesity care andBiopharmaceuticals. TheDiabetesandobesitycarebusinesssegmentincludesresearch,develop- ment,manufacturingandmarketingofproductswithintheareasofinsulin, GLP-1andrelateddeliverysystems,oralantidiabeticproducts(OAD)and obesity. TheBiopharmaceuticalsbusinesssegmentincludesresearch,development, manufacturingandmarketingofproductswithintheareasofhaemophilia, growthhormonetherapyandhormonereplacementtherapy.Inaddition, costsinrelationtoinflammatorydisorderswereincludedintheBiopharma- ceuticalsbusinesssegmentin2014.Pleaserefertonote2.3. BUSINESS SEGMENTS DKKmillion 2015 2014 2013 2015 2014 2013 2015 2014 2013 Segmentsales Diabetesandobesitycare Biopharmaceuticals Total New-generationinsulin 1,438 658 143 NovoRapid ® / NovoLog ® 20,720 17,449 16,848 NovoMix ® / NovoLog ® Mix 11,144 9,871 9,759 Levemir ® 18,300 14,217 11,546 Total moderninsulin 50,164 41,537 38,153 Humaninsulin 11,231 10,298 10,869 Victoza ® 18,027 13,426 11,633 Other diabetes and obesitycare 4,730 4,061 4,658 Diabetes and obesity care totalsales 85,590 69,980 65,456 Haemophilia 10,647 9,304 9,266 Norditropin ® (human growthhormone) 7,820 6,506 6,114 Otherbiopharmaceuticals 3,870 3,016 2,736 Biopharmaceuticals totalsales 22,337 18,826 18,116 Segment keyfigures Total net sales Change in DKK(%) Change in local currencies(%) Cost of goodssold Sales and distribution costs Research and development costs Administrativecosts Other operating income, net Income from partial divestmentof NNIT A/S (not allocated tosegments) Operatingprofit Operatingmargin Depreciation, amortisation and impairment losses expensed Additions to Intangible assets and Property, plant and equipment Assets allocated to business segments Non-allocatedassets 1 Totalassets 85,590 69,980 65,456 22,337 18,826 18,116 107,92 7 88,806 83,572 22.3% 6.9% 7.5% 18.6% 3.9% 5.7% 21.5% 6.3% 7.1% 8.9% 8.8% 12.0% 6.3% 6.2% 11.5% 8.4% 8.3% 11.9% 13,725 12,482 11,909 2,463 2,080 2,231 16,188 14,562 14,140 24,926 20,373 20,584 3,386 2,850 2,796 28,312 23,223 23,380 10,475 9,318 7,786 3,133 4,444 3,947 13,608 13,762 11,733 3,051 2,790 2,767 806 747 741 3,857 3,537 3,508 488 516 510 618 254 172 1,106 770 682 – – – – – – 2,376 – – 33,901 25,533 22,920 13,167 8,959 8,573 49,444 34,492 31,493 39.6% 36.5% 35.0% 58.9% 47.6% 47.3% 45.8% 38.8% 37.7% 2,514 2,438 2,209 445 997 590 2,959 3,435 2,799 4,991 3,245 2,651 1,415 1,066 990 6,406 4,311 3,641 46,444 40,748 36,436 11,759 10,914 10,525 58,203 51,662 46,961 33,596 25,400 23,376 91,799 77,062 70,337 1. The part of total assets that remains unallocated to either of the two business segments includes Investment in associated company, Deferred income tax assets, Other financial assets, Tax receivables, Marketable securities, Derivative financial instruments and Cash at bank and on hand.
NOVO NORDISK ANNUAL REPORT2015 •North America: the US andCanada •Europe: the EU, EFTA, Albania, Bosnia-Hercegovina, Macedonia, Serbia, Montenegro andKosovo •Japan & Korea: Japan and SouthKorea •Region China: China, Hong Kong andTaiwan •International Operations: all other countries. Asof1January2016,thegeographicalregionshavebeenchangedtoalign withmanagementstructure.Assuch,theUSwillbecomeaseparateregion, andCanadawilljoinJapanandSouthKoreatoformRegionPacific,together with AustraliaandNew Zealand(previouslyincludedin International Operations). Salesareattributedtogeographicalregionsaccordingtothelocationofthe customer.Allocationofproperty,plantandequipment,tradereceivables, allowancefortradereceivablesandtotalassetsisbasedonthelocationof theassets. Thecountryof domicileisDenmark,whichispartof RegionEurope. DenmarkisimmaterialtoNovoNordisk’sactivitiesintermsofgeographical sizeandtheoperationalbusinesssegments.Morethan99.5% oftotal salesarerealisedoutsideDenmark. SalestoexternalcustomersattributedtotheUSarecollectivelythemost materialtotheGroup.TheUSistheonlycountrywheresalescontribute morethan10%oftotalsales,andsalestotheUSrepresentmorethan90% ofsalesinRegionNorthAmerica. 66 CONSOLIDATED FINANCIALSTATEMENTS 2.2 SEGMENT INFORMATION(CONTINUED) Geographical areas Novo Nordisk operates in five geographicalregions: GROWTHANALYSIS Shareof Localcurrencies Growth growth New generationinsulin 109% 10% Moderninsulin 7% 41% Humaninsulin (1%) (1%) Victoza ® 18% 32% Other diabetes and obesitycare 5% 3% Diabetes and obesitycare 9% 85% Haemophilia 3% 3% Human growthhormone 8% 7% Otherbiopharmaceuticals 13% 5% Biopharmaceuticals 6% 15% SALES BY BUSINESSSEGMENT Q Diabetes and obesity care Q Haemophilia Q Human growthhormone Q Other Biopharmaceuticals 79% Totalsales 8% 100% 7% 10% 4% GEOGRAPHICALAREAS DKKmillion 2015 2014 2013 2015 2014 2013 NorthAmerica Europe Sales by business segment: NovoRapid ® / NovoLog ® NovoMix ® / NovoLog ® Mix Levemir ® Modern insulins (insulin analogues) Humaninsulins Victoza ® Other diabetes and obesitycare 12,576 2,837 13,295 28,708 2,094 13,014 1,442 10,191 2,483 9,386 22,060 1,997 9,046 846 9,953 2,694 6,823 19,470 1,976 7,537 1,590 4,239 2,181 2,929 9,349 2,014 3,394 1,225 3,999 2,317 2,939 9,255 2,222 3,130 1,009 3,819 2,450 2,909 9,178 2,427 2,896 885 Diabetes and obesity care total 45,258 33,949 30,573 15,982 15,616 15,386 Haemophilia Norditropin ® (human growth hormone) Otherbiopharmaceuticals 5,208 3,626 2,765 4,449 2,750 1,975 4,467 2,273 1,711 2,405 1,675 736 2,189 1,654 691 2,296 1,729 652 Biopharmaceuticalstotal 11,599 9,174 8,451 4,816 4,534 4,677 Total sales by business and geographical segment 56,857 43,123 39,024 20,798 20,150 20,063 Underlying sales growth in local currencies 1 Currency effect (local currencyimpact) 10.7% 21.1% 10.8% (0.3%) 17.8% (3.8%) 1.6% 1.6% 0.2% 0.2% 2.5% (0.7%) Total sales growth asreported 31.8% 10.5% 14.0% 3.2% 0.4% 1.8% Property, plant and equipment Tradereceivables Allowance for doubtful trade receivables Totalassets 3,050 6,618 (25) 12,854 2,215 4,359 (20) 9,131 1,571 3,076 (20) 7,057 19,097 3,856 (139) 65,241 17,411 3,866 (194) 54,526 16,801 3,779 (245) 51,205 1. Additional non-IFRS measure; please refer to p 94 for definition.
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 67 In2015,NovoNordiskhadthreemajorwholesalersdistributingproducts representingrespectively21%,12%and11%oftotalnetsales(18%, 10% and11%in2014and16%,11%and9%in2013).Netsalestothefirsttwo wholesalersarewithinbothdiabetesandbiopharmaceuticals,whereasthe thirdisonlywithindiabetes. Netsaleswillbeimpactedbyexchangeratefluctuations,whereasFinancial incomeandFinancialexpenseswillbeimpactedbythecorrespondingresults ofhedgingactivities.Pleaserefertonotes4.2,4.3and4.9formoredetails onhedging. Forpatentexpiryinkeymarketsbyproduct,pleaserefertonote2.5tothe Consolidatedsocialstatement. Shareof GROWTHANALYSIS Localcurrencies Totalsales 8% 100% SALES BYGEOGRAPHICAL AREA Q North America Q Europe Q InternationalOperations 53% 19% 14% Q Region China Q Japan &Korea Growth growth 5% NorthAmerica 11% 62% 9% Europe 2% 4% InternationalOperations 15% 26% RegionChina 4% 4% Japan &Korea 5% 4% 2015 2014 2013 2015 2014 2013 2015 2014 2013 Inte r nationalOperations RegionChina Japan &Korea 2,151 1,802 1,639 866 618 486 888 839 951 2,458 2,077 1,875 3,036 2,338 1,951 632 656 789 1,473 1,344 1,290 410 334 236 193 214 288 6,082 5,223 4,804 4,312 3,290 2,673 1,713 1,709 2,028 3,262 2,660 2,954 3,537 3,051 3,022 324 368 490 937 799 741 213 171 128 469 280 331 1,058 820 692 1,594 1,388 1,163 849 656 471 11,339 9,502 9,191 9,656 7,900 6,986 3,355 3,013 3,320 2,196 1,893 1,716 195 171 158 643 602 629 1,165 900 853 15 13 13 1,339 1,189 1,246 266 245 247 5 4 4 98 101 122 3,627 3,038 2,816 215 188 175 2,080 1,892 1,997 14,966 12,540 12,007 9,871 8,088 7,161 5,435 4,905 5,317 15.4% 14.4% 17.0% 4.1% 13.3% 12.7% 5.3% (0.8%) (0.1%) 4.0% (10.0%) (8.6%) 17.9% (0.4%) (0.8%) 5.5% (6.9%) (19.5%) 19.4% 4.4% 8.4% 22.0% 12.9% 11.9% 10.8% (7.7%) (19.6%) 953 1,145 1,292 2,291 2,230 2,078 154 135 140 3,015 2,978 2,196 1,532 1,538 1,587 464 300 269 (997) (776) (716) 0 0 0 (5) (5) (8) 6,765 6,821 5,945 5,594 5,629 5,108 1,345 955 1,022
NOVO NORDISK ANNUAL REPORT2015 Intotal,research comprises20–30%anddevelopment70–80%ofresearch and developmentcosts. The split between research and development will fluctuate in individual years depending on the composition of the clinical developmentportfolio. Researchcostsincludethecostsof theveryearlystagesof thedrug developmentcyclefromtheinitialdrugdiscoverytothefirstadministrationof thedrugtohumans.Theactivitiesinitiallyfocusonidentifyingasingledrug candidatewithaprofilethatwillsupportadecisiontoinitiatedevelopment activities.Beforeselectionofthefinaldrugcandidate,itistestedinanimals togatherefficacy,toxicityandpharmacokineticinformation. Developmentcostsareincurredfromthestartofphase1,whenthedrugis administeredtohumansforthefirsttime,ieprojectscapturedinthepipeline overviewonp20.Thefinalproductisbeingdeveloped,andsubsequent clinicaltrials(phase2and3)areconductedtofurthertestthedrugin humans,usingtheresultsfromthesetrialstoattempttoobtainmarketing authorisation,permittingNovoNordisktomarketandsellthedeveloped products. ACTIVITIESWITHININFLAMMATORYDISORDERS InSeptember2014,Managementdecidedtodiscontinueallresearchand developmentactivitieswithininflammatorydisorders.Thiswasastrategic decisionandassuchnotbasedonsafetyconcerns. Intotal,acostofDKK600millionwasrecordedaspartofresearchand developmentcostsin2014andnegativelyimpactedoperatingprofitin2014 intheBiopharmaceuticalsbusinesssegment. HISTORICAL RATIO OF RESEARCH ANDDEVELOPMENT COSTS2015 Q Research QDevelopment 70–80% DIABETES AND OBESITYCARE 20–30% BIOPHARMACEUTICALS 68 CONSOLIDATEDFINANCIALSTATEMENTS 2.3RESEARCHANDDEVELOPMENTCOSTS Accountingpolicies NovoNordisk’sresearchanddevelopmentisfocusedontherapeuticproteins withininsulinsfordiabetestreatment,GLP-1,bloodclottingfactorsand humangrowthhormone.Theresearchactivitiesutilisebiotechnological methodsbasedongeneticengineering,advancedproteinchemistryand proteinengineering.Thesemethodshaveplayedakeyroleinthedevelop- mentoftheproductiontechnologyusedtomanufactureinsulin,GLP-1, recombinantbloodclottingfactors,humangrowthhormoneandglucagon. Inlinewithindustrypractice,NovoNordiskexpensesallinternalresearch costs.Internaldevelopmentcostsarealsoexpensedasincurredasthesedo notqualifyforcapitalisationasintangibleassetsuntilmarketingapprovalby aregulatoryauthorityisobtainedorhighlyprobable,duetoregulatoryand otheruncertaintiesinherentinthedevelopmentofnewproducts. ResearchanddevelopmentactivitiesarecarriedoutbyNovoNordisk’s researchanddevelopmentcentres,mainlyinDenmark,theUSandChina, whileresearchanddevelopmenttrialsarecarriedoutallovertheworld. Withoutestablishingjointventuresor operations,NovoNordiskalso entersintopartnershipagreementstoalimitedextent,primarilyintermsof developmentandlicenceagreements. 25–35% 65–75% Researchanddevelopmentcostsprimarilycompriseemployeecosts,internal andexternalcostsrelatedtoexecutionofstudies,includingmanufacturing costs,facilitycostsoftheresearchcentres,andamortisation,depreciation andimpairmentlossesrelatedtointangibleassetsandproperty,plantand equipmentusedintheresearchanddevelopmentactivities. A very limited part of the research and development activities is recognised outside Research and developmentcosts: •Up-frontpaymentsandmilestonespaidtopartnershipspriortoorupon regulatoryapprovalarecapitalisedasintangibleassetsandamortisedas Costofgoodssoldovertheusefullife •Royaltyexpensespaidto partnershipsafterregulatoryapprovalare expensedasCostofgoodssold •RoyaltyincomereceivedfrompartnershipsisrecognisedaspartofOther operatingincome,net •Contractualresearchanddevelopmentobligationstobepaidinthefuture aredisclosedseparatelyasCommitmentsinnote5.3. RESEARCH AND DEVELOPMENTCOSTS DKKmillion 2015 2014 2013 Internal and external researchand developmentcosts 7,352 7,646 6,587 Employee costs (note2.4) 5,584 5,200 4,680 Amortisation and impairmentlosses, intangible assets (note3.1) 247 425 126 Depreciation and impairmentlosses, property, plant and equipment (note3.2) 425 491 340 Total research and developmentcosts 13,608 13,762 11,73 3 As percentage ofsales 12.6% 15.5% 14.0% For a review of development in research and development costs, refer to p 7 and p 10, ‘2015 performance and 2016outlook’. BY BUSINESS SEGMENT (NOTE2.2) DKKmillion 2015 2014 2013 Diabetes and obesitycare 10,475 9,318 7,786 Biopharmaceuticals 3,133 4,444 3,947 Total 13,608 13,762 11,733
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 69 2.4EMPLOYEECOSTS Accounting policies Wages,salaries,socialsecuritycontributions,annualleaveandsickleave, bonusesandnon-monetarybenefitsarerecognisedintheyearinwhichthe associatedservicesarerenderedbyemployeesofNovoNordisk.WhereNovo Nordiskprovideslong-termemployeebenefits,thecostsareaccruedto matchtherenderingoftheservicesbytheemployeesconcerned. EMPLOYEECOSTS ) ) 1.Thisreflectsannualgrossemployeecostsincludedinintangibleassetsandproperty, plantandequipmentthatwill subsequentlybe includedin depreciationand impairmentlosses. 2. Full-time equivalent employees in 2014 in NNIT A/S was approximately 2,400. DKKmillion 2015 2014 2013 Wages andsalaries 23,289 21,306 19,077 Share-based payment costs (note5.1) 442 371 409 Pensions –defined contributionplans 1,715 1,607 1,428 Pensions –defined benefitplans (note3.5) 154 142 113 Other social securitycontributions 1,783 1,617 1,489 Other employeecosts 2,117 1,944 1,891 Total employee costs for theyear 29,500 26,987 24,40 7 Employee costs included inintangible assets and property, plantand equipment 1 (957) (866) (77 2 Change in employee costsincluded ininventories (191) (206) (2 9 Total employeecosts in the Incomestatement 28,352 25,915 23,60 6 Included in the Incomestatement: Cost of goodssold 7,239 6,224 5,160 Sales and distributioncosts 12,231 10,334 9,831 Research and developmentcosts 5,584 5,200 4,680 Administrativecosts 2,658 2,426 2,250 Other operating income,net 640 1,731 1,685 Total employeecosts in the Incomestatement 28,352 25,915 23,60 6 REMUNERATION TO EXECUTIVE MANAGEMENTAND BOARD OFDIRECTORS Effective30April2015,NovoNordisk’sExecutiveManagementwasexpanded toincludefournewmembers.Remunerationtothenewmembershasbeen includedfrom30April2015. DKKmillion 2015 2014 2013 Salary and cashbonus 89 71 58 Pension 22 18 15 Benefits 4 7 2 2 Share-basedincentive 44 27 21 Severance payments 1,4 73 32 – Executive Management intotal 1,2,3 235 150 9 6 Fee to Board ofDirectors 12 9 9 Total 247 159 10 5 1.Please refer to note 5.1 and ’Remuneration’, pp 49 –51, for furtherinformation. 2.EVPKåreSchulzleftNovoNordiskasof30April2015.The2015remunerationfor KåreSchultzisincludedintheabovetabletogetherwithseverancepaymentsofDKK 72.7million.InNovember2014EVPLiseKingodecidedtoleaveNovoNordisk. The 2014remunerationforLiseKingoisincludedintheabovetabletogetherwith severancepaymentsofDKK32.2million. 3.TotalremunerationforregisteredmembersofExecutiveManagementamountsto DKK108million. 4.BenefitsisincludedinOtheremployeecostsandseverancepaymentsisincludedin wagesandsalariesinthetabletotheleft. 2.5OTHEROPERATINGINCOME,NET Accounting policies Otheroperatingincome(net)compriseslicenceincomeandincomeofa secondarynatureinrelationtothemainactivitiesofNovoNordisk.Licence incomeisrecognisedonanaccrualbasisinaccordancewiththetermsand substanceoftherelevantagreement.Netprofit,notrelatedto Novo Nordisk,from the whollyowned subsidiaryNNE PharmaplanA/S is recognisedasOtheroperatingincome.Otheroperatingincomealsoincludes incomefromsaleofintellectualpropertyrights. Divestedsubsidiariesarerecognisedintheconsolidatedincomestatement untilthetimewhencontrolislost.Netgainorlossondivestmentsis determinedasthedifferencebetweenthesalesproceedsandthe carrying Average number of full-timeemployees 2 40,342 40,164 36,144 amount of netassets. Year-end number of full-timeemployees 2 40,638 40,957 37,978 FINANCIAL IMPACT OF PARTIAL DIVESTMENT OF NNITA/S As a result of the Initial Public Offering of NNIT A/S on 6 March 2015, Novo Nordisk A/S disposed of 74.5% of the 100% interest held in thecompany. DKKmillion 2015 Sales proceeds from partial divestment Non-currentassets Currentassets Non-current liabilities Currentliabilities Retained 25.5% investment in NNITA/S Fair value revaluation of retainedinvestment 2,328 (431 ) (836 ) 67 601 153 644 Non-recurring income from divestment of 74.5% of NNITA/S 2,526 Costs related to the divestment (150) Net gainrecognised in the Income statement as part of ‘Other operating income,net’ 2,376 Sales proceeds from partial divestment Cash balancedisposed 2,328 (25 ) Consideration received recognised in the Cash flowstatement 2,303
NOVO NORDISK ANNUAL REPORT2015 70 CONSOLIDATED FINANCIALSTATEMENTS Key accounting estimate –Incometaxes DKKmillion 2015 2014 201 3 Current tax on profit for theyear 9,648 8,562 8,540 Deferred tax on profit for theyear (1,130) (748) (682 Tax on profit for theyear 8,518 7,814 7,85 8 Adjustments recognisedfor current tax of priorperiods 3 (313) (7 4 Adjustments recognisedfor deferred tax of priorperiods 102 114 (42 9 Income taxes inthe Incomestatement 8,623 7,615 7,35 5 Tax on other comprehensive income for the year,(income)/expense 87 (977) 21 1 Adjustmentsrecognisedforpriorperiodsincludeadjustmentscausedby eventsthatoccurredinthecurrentyearrelatedtocurrentanddeferredtaxof priorperiods.Suchadjustmentspredominantlyarisefromtaxpayments regardingtaxdisputesrelatedtotransferpricingandreversalofassociated taxliabilityrecognisedinpriorperiods. Taxonothercomprehensiveincomefortheyearrelatestotaxondeferred (gains)/lossesoncashflowhedgesandinternalprofitininventories.Thisloss isoffsetbycurrencyadjustmentofDKK99millionin2014recognisedas currenttaxinOthercomprehensiveincomein2015. the Danish tax rate is mainly driven by Swiss and US business activities. 2.6 INCOME TAXESANDDEFERRED DKKmillion 2015 2014 2013 INCOMETAXES Computation of effective taxrate: Statutory corporate income taxrate INCOMETAXES inDenmark 23.5% 24.5% 25.0% Deviation in foreignsubsidiaries’ Accountingpolicies tax rates compared with theDanish tax rate(net) (2.9%) (1.9%) (2.0%) The tax expense for the period comprises current and deferred taxand Non-taxable income frompartial interest on tax cases ongoing or settled during the year, includingadjust- divestment of NNITA/S (1.3%) – – ments to previous years and changes in provision for uncertaintaxpositions. Non-taxable income lessnon-tax- Tax is recognised in the Income statement, except to the extent thatitrelates deductible expenses(net) 0.1% (0.0%) (0.0%) to items recognised in Equity or in Other comprehensiveincome. Effect on deferred tax relatedto change in the Danish corporate taxrate – – (0.3%) Ongoing tax disputes, primarily related to transfer pricing cases,areincluded Other individually as part of deferred tax assets, tax receivables and tax payables. 0.4% (0.3%) (0.1%) Effective taxrate 19.8% 22.3% 22.6% Novo Nordisk is subject to income taxes around theworld.Significant Computation of effective taxamount: judgement is required in determining the worldwide accrualforincome Corporate income tax at taxrate taxes, deferred income tax assets and liabilities, and provision foruncertain inDenmark 10,218 8,354 8,135 tax positions. Novo Nordisk recognises deferred income tax assets ifit Impact from deviation inforeign is probable that sufficient taxable income will be available in thefuture subsidiaries’ tax rates comparedwith against which the temporary differences and unused tax losses canbeutilised. the Danish tax rate (net) (1,240) (623) (636) Management has considered future taxable income in assessingwhether Non-taxable income frompartial deferred income tax assets should be recognised. In the courseofconducting divestment of NNITA/S (558) – – business globally, transfer pricing disputes with tax authorities mayoccur, Non-taxable incomeless and Management judgement is applied to assess thepossibleoutcome non-tax-deductible expenses(net) 6 (12) (8) of such disputes. The most probable outcome is used as themeasurement Effect on deferred tax relatedto method, and Novo Nordisk believes that the provision made foruncertain change in the Danish corporate taxrate – – (99) tax positions not yet settled with local tax authorities is adequate.However, Other the actual obligation may deviate and is dependent on the result of 197 (104) (37) litigations and settlements with the relevanttaxauthorities. Effective taxamount 8,623 7,615 7,355 INCOMETAXESEXPENSED The impact of the deviation in foreign subsidiaries’ tax rates compared with INCOME TAXESPAID ) DKKmillion 2015 2014 2013 Income taxes paid inDenmark 5,469 4,936 7,363 ) Income taxes paid outsideDenmark 3,905 2,971 2,444 ) Total income taxespaid 9,374 7,907 9,807 The income taxes paid in Denmark in 2013 include adjustments arising from ongoing tax disputes primarily related to transfer pricing from prior periods. DEFERRED INCOMETAXES Accountingpolicies Deferredincometaxesarisefromtemporarydifferencesbetweenthe accountingandtaxablevaluesoftheindividualconsolidatedcompanies andfromrealisabletaxlosscarry-forwardsusingtheliabilitymethod.The taxvalueoftaxlosscarry-forwardsisincludedindeferredtaxassetstothe extentthatthetaxlossesandothertaxassetsareexpectedtobeutilisedin futuretaxableincome.Thedeferredincometaxesaremeasuredaccording tocurrenttaxrulesandatthetaxratesexpectedtobeinforceonelimina- tionofthetemporarydifferences.Ingeneral,theDanishtaxrulesrelatedto companydistributionsprovideexemptionfromtaxformostrepatriated profits.Noprovisionismadeforincometaxesthatwouldbepayableonthe distributionofunremittedearningsunlessaconcretedistributionofearnings isplanned.ThepotentialwithholdingtaxamountstoDKK288millionfor 2015(DKK212millionin2014).
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 71 2.6 INCOME AND DEFERRED INCOME TAXES(CONTINUED) DEVELOPMENT IN DEFERRED INCOME TAX ASSETS ANDLIABILITIES Property, Other, Provisions including and taxloss Offset DKKmillion plantand equipment Intangible assets Inventories accrued expenses carry- forwards within countries Total 2015 Net deferred tax asset/(liability) at 1January (715) 15 2,668 2,053 1,371 – 5,392 Income/(charge) to the Income statement (18) (368) 689 362 363 1,028 Income/(charge) to Other comprehensive income – – 236 8 (331) (87) Tax credit related to restricted stockunits 1 – – – – 356 356 Exchange rateadjustment (32) 16 – 136 (9) 111 Net deferred tax asset/(liability) at 31December (765) (337) 3,593 2,559 1,750 – 6,800 Classified asfollows: Deferred tax asset at 31December 219 186 4,650 2,566 1,897 (2,712) 6,806 Deferred tax liability at 31December (984) (523) (1,057) (7) (147) 2,712 (6) 1. In addition, DKK 10 million is recorded related to current tax on restricted stock units charged toequity. 2014 Net deferred tax asset/(liability) at 1January (853) 64 1,761 1,656 931 – 3,559 Income/(charge) to the Income statement 163 (57) 733 168 (373) 634 Income/(charge) to Other comprehensive income – – 174 69 833 1,076 Tax credit related to restricted stockunits – – – – – – Exchange rateadjustment (25) 8 – 160 (20) 123 Net deferred tax asset/(liability) at 31December (715) 15 2,668 2,053 1,371 – 5,392 Classified asfollows: Deferred tax asset at 31December 229 286 3,665 2,057 1,435 (2,273) 5,399 Deferred tax liability at 31December (944) (271) (997) (4) (64) 2,273 (7) SPECIFICATION OF TAX LOSS CARRY-FORWARDS AT 31DECEMBER DKKmillion 2015 2014 Recognised deferred tax loss carry-forwards 34 32 Unrecognised tax losscarry-forwards 243 215 Classified as follows: Expiry within one year 0 0 Expiry within two to fiveyears 7 8 Expiry after more than fiveyears 236 207
NOVO NORDISK ANNUAL REPORT2015 148.7% OPERATING PROFIT AFTER TAX TONET OPERATINGASSETS MAIN MOVEMENTS IN NET OPERATINGASSETS Netoperatingassets Fixedassets Inventories Receivables Provisions andliabilities DKKbillion 40 30 20 10 0 2014 2015 0 10 20 30 40 DKKbillion MAIN MOVEMENTS IN NET OPERATINGASSETS Q Net operating assets Q Fixed assets QInventories Q Receivables Q Provisions andliabilities 2014 2015 Foracquiredin-processresearchanddevelopmentprojects,theprobability effectisreflectedinthecostoftheasset,andtheprobabilityrecognition criteriaarethereforealwaysconsideredsatisfied.Asthecostofacquiredin- processresearchanddevelopmentprojectscanoftenbemeasuredreliably, theseprojectsfulfilthecapitalisationcriteriaasintangibleassets on acquisition. However,furtherinternaldevelopmentcostssubsequentto acquisitionaretreatedinthesamewayasotherinternaldevelopmentcosts. Impairmentofassets Intangibleassetswithanindefiniteusefullifeandintangibleassetsnotyet availableforusearenotsubjecttoamortisationbutaretestedannuallyfor impairment,irrespectiveofwhetherthereisanyindicationthattheymaybe impaired. Assetsthataresubjecttoamortisation,suchasintangibleassetsinuseor withdefiniteusefullife,andothernon-currentassetsarereviewedfor impairmentwhenevereventsorchangesincircumstancesindicatethatthe carryingamountmaynotberecoverable.Factorsconsideredmaterialthat couldtriggeranimpairmenttestincludethefollowing: •Development of a competingdrug •Changes in the legal framework covering patents, rights andlicences •Advances in medicine and/or technology that affect the medical treatments •Lower-than-predictedsales •Adverse impact on reputation and/or brandnames •Changes in the economic lives of similarassets •Relationship with other intangible assets or property, plant and equipment •Changes or anticipated changes in participation rates or reimbursement policies. Thissectionpresentsdetailsontheoperatingassetsthatformthebasisfor theactivitiesofNovoNordisk,andrelatedliabilities.Thesenetassetsimpact NovoNordisk’slong-termtargetfor‘Operatingprofitaftertaxto net operatingassets(OPAT/NOA)’. 149% OPERATING PROFIT AFTERTAX TO NET OPERATINGASSETS For2015,OPAT/NOAamountsto148.7%,representinganincreaseofmore than70percentagepointsoverthelastfiveyearsandreflectingthegrowth inOperatingprofitaftertaxgeneratedonastablebaseofnetoperating assets. ThisisdrivenbyNovoNordisk’sorganicgrowthstrategywithlimited acquisitionofintangibleassetsorbusinessesingeneral.Italsoreflectsthe factthat,inlinewithindustrypractice,NovoNordiskdoesnotcapitalise internaldevelopmentcosts. Theoverallapproachtomanagingoperatingassetsistoretainassetsfor research,developmentandproductionactivitiesunderthecompany’sown control,andgenerallytoleasenon-coreassetsrelatedtoadministrationand distribution.Thisisakeyfactorinmaintaininghighqualityinthecompany’s products. Furthermore,beingableat alltimesto deliverproductsto customersisa keypriority; consequentlythetotalproductioncapacity reflectsthispriority,andtheinventorylevelincludesalevelofsafetystock. IMPACTOFUSREBATES Asignificantfactorinnetoperatingassetsalsorelatestothemovementin theprovisionforsalesrebatesintheUS,presentedasprovisionsunder currentliabilitiesintheBalancesheet.Themovementin2015reflectsgrowth inUSsales,nationalexpansionoftheMedicaidprogrammeandchangesin productandrebateprogrammemix.Thisiscounteredbytheeffectoffaster collectionfrompharmacybenefitmanagersandauthorities.Theincreasein inventorylevelpartlyreflectsadditionalsafetystockandnewproducts.Trade receivablesandfixedassetshavedevelopedinlinewithnetsales. 72 CONSOLIDATED FINANCIALSTATEMENTS SECTION 3 OPERATING ASSETS ANDLIABILITIES 3.1INTANGIBLEASSETS Accountingpolicies Patentsandlicences,includingacquiredpatentsandlicencesforin-process researchanddevelopmentprojects,arecarriedat historicalcostless accumulatedamortisationandanyimpairmentloss.Amortisationisbasedon thestraight-linemethodovertheestimatedusefullife,whichistheshorterof thelegaldurationandtheeconomicusefullife,notexceeding10years. The amortisationofpatentsandlicencesbeginsafterregulatoryapprovalhas beenobtained. Internaldevelopmentofcomputersoftwareandotherdirectlyattributable developmentcostsrelatedtomajorITprojectsforinternalusearerecognised asintangibleassetsiftherecognitioncriteriaaremet,iea significant businesssystemwheretheexpenditureleadstothecreationofadurable asset.Amortisationisbasedonthestraight-linemethodovertheestimated usefullifeof3–10years.Theamortisationbeginswhentheassetisinthe locationandconditionnecessaryforittobecapableofoperatinginthe mannerintendedbyManagement. Researchanddevelopment projects Internalresearchcostsarefullychargedto theconsolidatedincome statementintheperiodinwhichtheyareincurred,consistentwithindustry practice;pleaserefertonote2.3. Basis ofpreparation Results for theyear Operatingassets andliabilities Capital structure and ?nancingitems Otherdisclosures
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 73 3.2PROPERTY,PLANTANDEQUIPMENT Accountingpolicies Property,plantandequipmentismeasuredathistoricalcostlessaccu- mulateddepreciationandanyimpairmentloss.Thecostofself-constructed assetsincludescostsdirectlyandindirectlyattributabletotheconstruction oftheassets.Subsequentcostisincludedintheasset’scarryingamountor recognisedasaseparateassetonlywhenitisprobablethatfutureeconomic benefitsassociatedwiththeitemwillflowtoNovoNordiskandthecostof theitemcanbe measuredreliably. In general,constructionof major investmentsisself-financedandthusnointerestonloansiscapitalisedas partofthecost.Depreciationisbasedonthestraight-linemethodoverthe estimatedusefullivesoftheassets: •Buildings:12–50years •Plant and machinery: 5 –16years •Other equipment: 3 –10years •Land: notdepreciated. Thedepreciationcommenceswhentheassetisavailableforuse,iewhenitis inthelocationandconditionnecessaryforittobecapableofoperatingin themannerintendedbyManagement. Theassets’residualvaluesandusefullivesarereviewedandadjusted,if appropriate,attheendofeachreportingperiod.Iftheasset’scarrying amountishigherthanitsestimatedrecoverableamount,itiswrittendownto therecoverableamount; pleasereferto note3.1fora descriptionof impairmentofassets.Gainsandlossesondisposalsaredeterminedby comparingtheproceedswiththecarryingamountandarerecognisedinthe Incomestatement. Plantandequipmentwithnoalternativeusedevelopedaspartofaresearch anddevelopmentprojectisexpensed.However,plantandequipmentwith analternativeuseorusedforgeneralresearchanddevelopmentpurposesis capitalisedanddepreciatedoveritsestimatedusefullifeasresearchand developmentcosts. 3.1INTANGIBLEASSETS(CONTINUED) Ifthecarryingamountofintangibleassetsexceedstherecoverableamount basedontheexistenceofoneormoreoftheaboveindicatorsofimpairment, anyimpairmentismeasuredbasedondiscountedprojectedcashflows. Impairmentsarereviewedateachreportingdateforpossiblereversal. INTANGIBLEASSETS DKKmillion 2015 2014 Patents andlicences In-process and developedsoftware 1,139 1,019 454 924 Total 2,158 1,378 In 2015, an impairment loss of DKK 243 million (DKK 423 million in 2014) related to patents and licences wasrecognised. IntangibleassetsnotyetinuseamounttoDKK1,261million(DKK656 millionin2014),primarilypatentsandlicencesinrelationtoresearchand developmentprojects.Impairmenttestsin2015and2014ofpatentsand licencesnot yetin usearebasedon Management’sprojectionsand anticipatednet presentvalueof estimatedfuturecashflows from marketableproducts.Managementhasusedapre-taxdiscountrate(WACC) of8% basedontheriskinherentintherelatedactivity’scurrentbusiness modelandindustrycomparisons.Terminalvaluesusedarebasedonthe expectedlifeofproducts,forecastedlifecycleandcashflowoverthat period,andtheusefullifeoftheunderlyingassets. AMORTISATION AND IMPAIRMENTLOSSES DKKmillion 2015 2014 Cost of goodssold 127 105 Sales and distributioncosts 11 28 Research and developmentcosts 247 425 Other operating income,net 7 8 Total amortisation and impairmentlosses 392 566 For further information regarding 2014 impairment of inflammationprojects, please refer to note2.3.
NOVO NORDISK ANNUAL REPORT2015 74 CONSOLIDATED FINANCIALSTATEMENTS 3.2 PROPERTY, PLANT AND EQUIPMENT(CONTINUED) PROPERTY, PLANT ANDEQUIPMENT Assetsin DKKmillion Landand buildings Plantand machinery Other equipment courseof construction Total 2015 Cost at the beginning of theyear 17,391 20,410 3,882 5,801 47,484 Additions during theyear 334 456 222 4,212 5,224 Disposals during theyear (159) (366) (228) – (753) Disposals related to partial divestment of NNITA/S (188) (2) (657) – (847) Transfer from/(to) otheritems 658 1,565 264 (2,487) 0 Effect of exchange rateadjustment (33) (28) 33 90 62 Cost at the end of theyear 18,003 22,035 3,516 7,616 51,170 Depreciation and impairment losses at the beginning of theyear 6,933 14,910 2,505 – 24,348 Depreciation for theyear 761 1,381 328 – 2,470 Impairment losses for theyear 8 65 24 – 97 Depreciation and impairment losses reversed on disposals during theyear (140) (332) (215) – (687) Depreciation reversed related to partial divestment of NNITA/S (61) (2) (387) – (450) Effect of exchange rateadjustment (53) (122) 22 – (153) Depreciation and impairment losses at the end of theyear 7,448 15,900 2,277 – 25,625 Carrying amount attheendoftheyear 10,555 6,135 1,239 7,616 25,545 2014 Cost at the beginning of theyear 16,184 18,964 3,457 5,432 44,037 Additions during theyear 234 459 384 2,913 3,990 Disposals during theyear (392) (324) (279) – (995) Transfer from/(to) otheritems 1,156 1,168 250 (2,574) 0 Effect of exchange rateadjustment 209 143 70 30 452 Cost at the end of theyear 17,391 20,410 3,882 5,801 47,484 Depreciation and impairment losses at the beginning of theyear 6,267 13,614 2,274 – 22,155 Depreciation for theyear 855 1,436 362 – 2,653 Impairment losses for theyear 94 42 80 – 216 Depreciation and impairment losses reversed on disposals during theyear (297) (265) (260) – (822) Effect of exchange rateadjustment 14 83 49 – 146 Depreciation and impairment losses at the end of theyear 6,933 14,910 2,505 – 24,348 Carrying amount at the end of theyear 10,458 5,500 1,377 5,801 23,136 DEPRECIATION AND IMPAIRMENTLOSSES DKKmillion 2015 2014 Cost of goodssold 2,008 2,141 Sales and distributioncosts 54 36 Research and development costs 425 491 Administrative costs 53 83 Other operating income, net 27 118 Total depreciation and impairment losses 2,567 2,869
NOVO NORDISK ANNUAL REPORT2015 3.3INVENTORIES Accountingpolicies Inventoriesarestatedatthelowerofcostandnetrealisablevalue.Costis determinedusingthefirst-in, first-out method. Costcomprisesdirect productioncostssuchasrawmaterials,consumablesandlabouraswellas indirectproductioncosts.Productioncostsforworkinprogressandfinished goodsincludeindirectproductioncostssuchasemployeecosts,deprecia- tion,maintenanceetc. Iftheexpectedsalespricelesscompletioncoststoexecutesales(netrealis- ablevalue)islowerthanthecarryingamount,awrite-downisrecognisedfor theamountbywhichthecarryingamountexceedsitsnetrealisablevalue. Inventorymanufacturedpriortoregulatoryapproval(pre-launchinventory)is capitalisedbutimmediatelyprovidedfor,untilthereisahighprobabilityof regulatoryapprovaloftheproduct.Beforethatpoint,aprovisionis made againstthecarryingamountofinventorytoitsrecoverableamount and recordedasresearchanddevelopmentcosts.Atthepointwhenahigh probabilityofregulatoryapprovalisobtained,theprovisionrecordedis reversed,uptonomorethantheoriginalcost. Key accounting estimate –Indirect productioncosts Indirectproductioncostsaccountfor50% ofthenetinventoryvalue, reflectinga lengthyproductionprocesscomparedwithlow directraw materialcost. Theproductionof bothdiabetesandobesitycareand Biopharmaceuticalproductsis highlycomplexfrom fermentationto purificationandformulation,includingqualitycontrolofallproduction processes. Furthermore,theprocessisverysensitiveto manufacturing conditions.Thesefactorsallinfluencetheparametersforcapitalisationof indirectproductioncostsinNovoNordiskandfullcostoftheproducts. Indirectproductioncostsaremeasuredusingastandardcostmethod,which isreviewedregularlytoensurerelevantmeasuresofcapacityutilisation, productionleadtime,costbaseandotherrelevantfactors,henceinventoryis valuedatactualcost.Whencalculatingtotalinventory,Managementmust makecertainjudgementsaboutcostofproduction,standardcostvariances andidlecapacityinestimatingindirectproductioncostsforcapitalisation. Changesintheparametersforcalculationofindirectproductioncostscould haveanimpactonthegrossmarginandtheoverallvaluationofinventories. INVENTORIES ) ) DKKmillion 2015 2014 Rawmaterials 2,020 1,723 Work inprogress 8,549 7,539 Finishedgoods 3,608 3,260 Total inventories(gross) 14,177 12,522 Inventory write-downs atyear-end 1,419 1,165 Total inventories(net) 12,758 11,357 Indirect production costs includedin work in progress and finishedgoods 6,436 5,759 Share of total inventories(net) 50% 51% MOVEMENTS ININVENTORY WRITE-DOWNS Inventory write-downs at the beginning of the year 1,165 960 Inventory write-downs during theyear 698 467 Utilisation of inventorywrite-downs (192) (123 Reversal of inventorywrite-downs (252) (139 Inventorywrite-downsattheendoftheyear 1,419 1,165 CONSOLIDATED FINANCIAL STATEMENTS 75 3.4TRADERECEIVABLES Accountingpolicies Tradereceivablesarerecognisedinitiallyatfairvalueandsubsequently measuredat amortisedcostusingtheeffectiveinterestmethod,less allowancefordoubtfultradereceivables. TheallowanceisdeductedfromthecarryingamountofTradereceivables andtheamountofthelossisrecognisedintheIncomestatementunder Salesanddistributioncosts.Subsequentrecoveriesofamountspreviously writtenoffarecreditedagainstSalesanddistributioncosts. Key accounting estimate– Allowancefordoubtfultradereceivables ThecustomerbaseofNovoNordiskcomprisesgovernmentagencies,whole- salers,retailpharmacies,managedcareandothercustomers.Management makesallowancefordoubtfultradereceivablesinanticipationofestimated lossesresultingfromthesubsequentinabilityofcustomerstomakerequired payments.Ifthefinancialcircumstancesofcustomersweretodeteriorate, resultinginanimpairmentoftheirabilitytomakepayments,anadditional allowancecouldbe requiredin futureperiods. When evaluatingthe adequacyoftheallowancefordoubtfultradereceivables,Management analysestradereceivablesandexamineshistoricalbaddebt,customer concentrations,customercreditworthinessandpaymenthistory,current economictrendsandchangesincustomerpaymentterms.Pleasereferto note4.2forageneraldescriptionofcreditrisk. AsaresultofthesignificantsalestocountrieswithinRegionInternational Operations,andthefactthatmanyofthesecountrieshavelowcreditratings, therelativeimpactofcountrieswithinRegionInternationalOperationson theallowancefordoubtfultradereceivablesisincreasing. Thepolitical climateinRussiaandArgentinaisimpactedbyinstabilityandsharpcurrency depreciation.NovoNordiskismonitoringdevelopmentsclosely.Payment historyaswellascurrenteconomicconditionsandindicatorsaretakeninto accountinthevaluationoftradereceivables. Please refer to note 2.2 for a geographical split of trade receivables and allowance for doubtful tradereceivables. TRADERECEIVABLES ) ) ) There is no inventory carried at net realisable value at 31 December for either 2014 or 2015, except for the fully impaired inventory disclosed in thetable. DKKmillion 2015 2014 Trade receivables(gross) 16,651 14,036 Allowance for doubtful tradereceivables 1,166 995 Trade receivables(net) 15,485 13,041 Trade receivables (net) equals a creditperiod of 52 days (54 days in2014). Age analysis of tradereceivables Non-impaired tradereceivables –Not yetdue 14,605 12,664 –Overdue by between 1 and 179days 880 337 –Overdue by between 180 and 360days 0 40 Trade receivables with credit riskexposure 15,485 13,041 MOVEMENTS IN ALLOWANCEFOR DOUBTFUL TRADERECEIVABLES Carrying amount at the beginning of theyear 995 989 Confirmedlosses (28) (13 Reversal of allowance for confirmedlosses (26) (11 Allowance for possible losses during theyear 257 57 Effect of exchange rateadjustment (32) (27 Allowanceattheendoftheyear 1,166 995
NOVO NORDISK ANNUAL REPORT2015 76 CONSOLIDATEDFINANCIALSTATEMENTS 3.5 RETIREMENTBENEFITOBLIGATIONS Accountingpolicies NovoNordiskoperates a number of defined contribution plans throughout the world. NovoNordisk’scontributions to the defined contribution plans arecharged tothe Income statement in the year towhich they relate.Ina few countries, NovoNordiskstilloperates defined benefit plans.Thedefined benefit plans for Germany coverall employees employed before November 2003.Obligations relating toemployees employed after 2003 arecoveredby a defined contribution plan. In Switzerland the employee pension scheme is set up as a combined defined benefit and defined contribution plan, and ismandatory.Theplan inJapan coversall employees and issetup as a combined defined benefit and defined contribution plan.Theplan intheUS is structured as a post-retirement healthcare plan covering all employees. From2012 thisplan was changed into a defined contribution plan covering allUSemployees. The costs for the year for defined benefit plans are determined using the projectedunit creditmethod.Thisreflectsservicesrenderedbyemployees to thevaluation dates and isbased onactuarial assumptions primarilyregarding discount rates used in determining the present value of benefits and projected rates of remuneration growth. Discount rates are based on the marketyieldsofhigh-rated corporatebonds inthecountryconcerned. Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are charged or credited to Other comprehensive income in the period in which they arise. Past service costs are recognised immediately intheIncomestatement. Pension plan assets are only recognised tothe extent that NovoNordiskis able to derive future economic benefits such as refunds from the plan or reductionsof future contributions.NovoNordiskmanages theallocation and investment of pension plan assets with the purpose of meeting the long- termobjectives.Themain objectives aretomeet present and future benefit obligations, provide sufficient liquidity to meet such payment requirements and provide a total returnthat maximises the ratioof the plan assets tothe plan liabilities by maximising returnon the assets at an appropriate level of risk. TheGroup’sdefined benefit plans are pension plans and medical plans and are usually funded by payments from Group companies and by employees tofunds independent of NovoNordisk.Wherea plan isunfunded, a liability fortheretirementbenefit obligation isrecognised intheBalance sheet.Costs recognised forretirementbenefits are included in Costof goods sold, Sales and distribution costs, Research and development costs, and Administrative costs. The netobligation recognised intheBalance sheetisreportedasnon-current liabilities. RETIREMENT BENEFITOBLIGATIONS ) ) 2 DKKmillion Germany Switzerland Japan US Other 2015 Total 2014 Tota l At the beginning of theyear 710 246 318 381 320 1,975 1,544 Current servicecosts 28 31 31 26 32 148 121 Past service costs and settlements – (11) – – (35) (46) (2 Interestcosts 18 4 3 15 7 47 49 Remeasurement (gains)/losses 1 10 39 1 (24) 18 44 250 Plan participant contributions etc – 11 – – 14 25 15 Benefits paid toemployees (5) (4) (17) (9) 1 (34) (41 Exchange rateadjustment 2 28 34 44 1 109 39 Attheendoftheyear 763 344 370 433 358 2,268 2 1,975 FAIR VALUE OF PLANASSETS At the beginning of theyear 441 169 250 – 84 944 856 Interestincome 12 3 2 – 3 20 24 Settlements – – – – (22) (22) – Remeasurement gains/(losses) 1 – 6 – – 7 3 Employercontributions 22 24 28 9 13 96 85 Plan participant contributions etc – 11 – – 11 22 17 Benefits paid toemployees (5) (4) (17) (9) 1 (34) (41) Exchange rateadjustment 1 20 27 – 1 49 – Attheendoftheyear 472 223 296 – 91 1,082 944 Net retirement benefitobligations attheendoftheyear 291 121 74 433 267 1,186 1,031 1.Remeasurement relates primarily to changes in financial assumptions. 2.Present value of partly funded retirement benefit obligations amounts to DKK 1,711 million (DKK 1,478 million in 2014). Present value of unfunded retirement benefit obligations amounts to DKK 557 million (DKK 497 million in2014).
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 77 3.6 PROVISIONS AND CONTINGENT LIABILITIES Accountingpolicies Provisionsforsalesrebatesanddiscountsgrantedtogovernmentagencies, wholesalers,retailpharmacies,managedcareandothercustomersare recordedatthetimetherelatedrevenuesarerecordedorwhentheincentives areoffered.Provisionsarecalculatedbasedonhistoricalexperienceandthe specifictermsintheindividualagreements. Provisionsforlegaldisputesarerecognisedwherealegalorconstructive obligationhasbeenincurredasaresultofpasteventsanditisprobablethat therewillbeanoutflowofresourcesthatcanbereliablyestimated.Inthis case,NovoNordiskarrivesatanestimatebasedonanevaluationofthemost likelyoutcome.Disputesforwhichnoreliableestimatecanbemadeare disclosedascontingentliabilities. NovoNordiskissuescreditnotesforexpiredgoodsasapartofnormal business.Wherethereishistoricalexperienceorareasonablyaccurate estimateofexpectedfuturereturnscanotherwisebemade,aprovisionfor estimatedproductreturnsisrecorded.Theprovisionismeasuredatgross salesvalue. Provisionsaremeasuredatthepresentvalueoftheanticipatedexpenditure forsettlementofthelegalorconstructiveobligationusingapre-taxdiscount ratethatreflectscurrentmarketassessmentsofthetimevalueofmoneyand therisksspecifictotheobligation.Theincreaseintheprovisionduetothe passageoftimeisrecognisedasafinancialexpense. Key accounting estimate –Provisions for salesrebates NovoNordiskrecordsprovisionsforexpectedsalesrebates,includingMedicaid andMedicareintheUS.ExpectedrebatesarerecognisedasProvisionswhen timingoramountisuncertain.Whereabsoluteamountsareknown,the rebatesarerecognisedasOtherliabilities. Suchestimatesarebasedonanalysesofexistingcontractualobligationsand historicalexperience.Provisionsarecalculatedonthebasisofapercentage ofsalesforeachproductasdefinedbythecontractswiththevarious customergroups. Provisionsforsalesrebatesareadjustedtoactualamountsasrebates, discountsandreturnsareprocessed.Pleaserefertonote2.1forfurther informationonsalesrebatesandprovisions. NovoNordiskconsiderstheprovisionsestablishedforsalesrebatestobe reasonableandappropriatebasedon currentlyavailableinformation. However,theactualamountofrebatesanddiscountsmaydifferfromthe amountsestimatedbyManagementasmoredetailedinformationbecomes available. Key accounting estimate –Provisions for legaldisputes Provisionsforlegaldisputesconsistofvarioustypesofprovisionlinkedto ongoinglegaldisputes.Managementmakesjudgementsaboutprovisions andcontingencies,includingtheprobabilityofpendingandpotentialfuture litigationoutcomes,which,bytheirverynature,aredependentoninherently uncertainfutureevents.Whendetermininglikelyoutcomesoflitigationsetc, Managementconsiderstheinputofexternalcounselsoneachcase,aswell asknownoutcomesincaselaw. AlthoughManagementbelievesthat the total provisionsfor legal proceedingsareadequatebasedoncurrentlyavailableinformation,there canbenoassurancethattherewillnotbeanychangesinfactsormatters,or thatanyfuturelawsuits,claims,proceedingsorinvestigationswillnotbe material. 3.5 RETIREMENT BENEFIT OBLIGATIONS (CONTINUED) NET RETIREMENT BENEFITOBLIGATIONS DKKmillion 2015 2014 1,031 154 688 142 At the beginning of theyear Costs recognised in the Income statement 1 Remeasurements recognisedin Other comprehensive income Employer contributions Exchange rate adjustment 2 37 (96) 60 247 (85) 39 Attheendoftheyear 1,186 1,031 1.Employee costs comprising service costs, net interest, settlements and plan participant contributions etc. Please refer to note2.4. 2.As part of exchange rate adjustments in subsidiaries recognised in Other com- prehensiveincome. Please refer to note 5.3 for a maturity analysis of the net retirement benefit obligation. Novo Nordisk does not expect the contributions over the next five years to differ significantly from currentcontributions. WEIGHTED AVERAGE ASSET ALLOCATION OF FUNDED RETIREMENTOBLIGATIONS 2015 201 4 DK K millio n % DK K millio n % Coverageinsurance 1 695 64% 632 67% Bonds 244 23% 204 22% Equities 91 8% 76 8% Cash atbank 36 3% 21 2% Property 16 2% 11 1% Total 1,082 100% 944 100% 1.NovoNordisk’sdefinedbenefitplans,mainlyinGermanyandSwitzerland,are reimbursedbytheinternationalinsurerAllianzregardlessofthevalueoftheplan assets.Theriskrelatedtotheplanassetsinthesecountriesisthereforecounterparty riskagainstAllianz. KEY ASSUMPTIONS USED FORVALUATION 2015 Weighted average 2014 Weighted average Discountrate 2% 2% Projected future remunerationincreases 2% 2% Actuarialvaluationsareperformedannuallyforallmajordefinedbenefit plans.Assumptionsregardingfuturemortalityarebasedonactuarialadvice inaccordancewithpublishedstatisticsandexperienceineachcountry.Other assumptionssuchasmedicalcosttrendrateandinflationarealsoconsidered inthecalculation. Significantactuarialassumptionsforthedeterminationoftheretirement benefitobligationarediscountrateandexpectedfutureremuneration increases.Thesensitivityanalysisbelowhasbeendeterminedbasedon reasonablylikelychangesintheassumptionsoccurringattheendofthe period. DKKmillion 1%-point increas e 1%-point decreas e Discountrate (323) 414 Futureremuneration 94 (84) Thesensitivitiesaboveconsiderthesinglechangeshownwiththeother assumptionsassumedto be unchanged. In practice,changesin one assumptionmaybeaccompaniedbyoffsettingchangesinanotherassump- tion(althoughthisisnotalwaysthecase).
NOVO NORDISK ANNUAL REPORT2015 On21 January 2016, the Centers for Medicare & Medicaid Services (CMS) inthe USpublished itsfinal ruleimplementing Affordable CareActchanges to the Medicaid Drug Rebate Program and Medicaid reimbursement for covered outpatient drugs. The rule creates a regulatory definition for Average Manufacturer Price, the key metric for determining manufacturer rebates and pharmacy reimbursement under the Medicaid programme, including Norditropin ® . Management has reviewed the implications of the final rule and assessed that the rule does not have a material impact on NovoNordisk’sfinancial position, operating profitorcash flow fortheperiod ended 31 December2015. Contingentliabilities NovoNordiskiscurrentlyinvolvedinpending litigations, claims and investiga- tionsarising outofthenormal conduct of itsbusiness.Whileprovisionsthat Management deems tobe reasonable and appropriate have been made for probable losses, there are uncertainties connected with these estimates. NovoNordiskdoes not expect the pending litigations, claims and investiga- tions, individually and in the aggregate, tohave a material impact on Novo Nordisk’sfinancial position, operating profit orcash flow in addition tothe amounts accrued asprovisionforlegal disputes. PendinglitigationagainstNovoNordisk In the US, a number of claims alleging pancreatic cancer and pancreatitis have been filed against various incretin-based product manufacturers, including NovoNordisk.As of 1 February 2016, NovoNordiskwas named by 194 plaintiffs in product liability cases related to Victoza ® and other GLP-1/DPP-IVproducts, predominantly alleging pancreatic cancer.134 of the NovoNordiskplaintiffs have alsonamed otherdefendants intheir lawsuits. 78 CONSOLIDATED FINANCIALSTATEMENTS 3.6 PROVISIONS AND CONTINGENT LIABILITIES(CONTINUED) PROVISIONS ) ) DKKmillion Provisions forsales rebates Provisions forlegal disputes Provisions forproduct returns Other provisions 1 2015 Total 2014 Tota l At the beginning of theyear 11,002 936 797 896 13,631 10,493 Additional provisions, including increases to existing provisions 45,190 602 319 507 46,618 27,208 Amount used during theyear (40,958) (126) (313) (324) (41,721) (24,754 Adjustments, including unused amounts reversed during the year – (52) – (4) (56) (462 Effect of exchange rateadjustment 1,274 37 – 41 1,352 1,146 Attheendoftheyear 16,508 1,397 803 1,116 19,824 13,631 Non-currentliabilities – 1,397 482 886 2,765 2,041 Currentliabilities 16,508 – 321 230 17,059 11,590 1. Other provisions consist of various types of provision, including employee benefits such as jubilee benefits, company -owned life insurance etc. Assets related to company-owned life insurance are presented as part of Other financial assets. For non-current liabilities, provisions for product returns will be utilised in 2017 and 2018 and other provisions will be utilised in 2017. For provisions for legal disputes, the time of settlement cannot be determined. PROVISIONS FOR SALESREBATES Q 2014 Q2015 0 1500 3000 4500 6000 7500 USMedicaid USMedicare USManaged Care Other Sales Rebates DKKmillion Judgement of dismissal has been entered in NovoNordisk’sfavour in the vast majority of cases naming the company as a defendant . A notice of appeal hasbeen filed inbothstateand federal cases.Currently,NovoNordisk does not have any individual trials scheduled in 2016. NovoNordiskdoes not expectthe pending claims tohave a material impact on NovoNordisk’s financial position, operating profitorcash flow. Pending claims against Novo Nordisk and investigations involving NovoNordisk In February 2011, the office of the US Attorney for the Districtof Massa- chusetts servedNovoNordiskwith a subpoena calling fortheproduction of documents regarding potential civil and criminal offences relating to the company’s marketing and promotional practices for the following products: NovoLog ® ,Levemir ® and Victoza ® .Thismatter isbeing conducted bytheUS Attorney forthe Districtof Columbia.NovoNordiskcontinues tocooperate with theUSAttorneyinthisinvestigation.NovoNordiskdoesnotexpectthe investigation tohave a material impact onNovoNordisk’sfinancial position, operating profitorcashflow. ® Following thelaunch ofNovoEight (‘N8’)inApril2015, Baxter(nowBaxalta) filed a complaint regarding patent infringement with the US International TradeCommission (‘ITC’).TheBaxalta patents, which expire in June 2018, all relatetomanufacturing therapeutic protein products, such as FactorVIII. Aparallel lawsuit ispending inthe USDistrictCourtforthe Districtof New Jerseybuthas been stayed pending resolutionofthematterintheITC.Novo Nordiskdoes not expect these matters to have a material impact on Novo Nordisk’sfinancial position, operating profitorcash flow. In addition to the above, the NovoNordiskGroup is engaged in certain litigation proceedings and various ongoing audits and investigations . In the opinion of Management, neither settlement or continuation of such proceedings norsuchpending audits and investigations areexpected tohave a material effect on NovoNordisk’sfinancial position, operating profit or cashflow. 3.7 OTHERLIABILITIES OTHERLIABILITIES DKKmillion 2015 2014 Employee costspayable 4,545 4,454 Accruals 4,285 3,684 Accruedrebates 1,555 912 VAT and dutiespayable 896 744 Research and development clinicaltrials 532 763 Amount owed to associated company 259 – Otherpayables 583 494 Total otherliabilities 12,655 11,051
NOVO NORDISK ANNUAL REPORT2015 NETPROFITANDFREECASHFLOW Netpro?t Free cash?ow DKKbillion 40 30 20 10 0 2014 2015 88% NET CASH DISTRIBUTED TO SHAREHOLDERSIN PERCENT OF FREE CASHFLOW 0 10 20 30 40 2014 2015 88% NET CASH DISTRIBUTED TOSHAREHOLDERS IN PERCENT OF FREE CASHFLOW DKKbillion NETPROFITANDFREECASHFLOW Q Net pro?t Q Free cash?ow The notes in this section provide an insight into Novo Nordisk’s capital structure, earnings per share, free cash flow and financing items. Thefree cash flow impacts NovoNordisk’slong-term target for ‘Cash to earnings (three-year average)’. Cash to earnings is defined as ‘free cash flow as a percentage of net profit’.Freecash flow isthe cash amount generated that is available for further investments in Novo Nordisk and distribution to shareholders without consuming prior years’ cash creation retained in the company. NovoNordisk has a low debt-to-equity ratio reflecting growth based on limited debt financing . Further information on the company’s capital structurecanbefound in Sharesand capital structure’onpp44–45. Themain financial risk is foreign exchange exposure, where NovoNordisk aims toreduce the short-termimpact from movements in key currenciesby hedging future cash flows. Notes4.2 and 4.3 include more information in thisrespect. Netcashdistribution toshareholders In2015, the net cash distribution toshareholders in the form of dividends and share repurchases amounts to DKK30.1 billion compared with free cash flow of DKK34.2 billion in line with the guiding principle of paying out excess capital to investors after funding organic growth and potential acquisitions. CONSOLIDATED FINANCIAL STATEMENTS 79 SECTION 4 CAPITAL STRUCTURE AND FINANCINGITEMS 4.1 SHARE CAPITAL, DISTRIBUTION TO SHAREHOLDERS AND EARNINGS PER SHARE SHARECAPITAL DKKmillion Ashare capital Bshare capital Totalshare capital Development in sharecapital: Share capital 2011 107 473 580 Cancelled in2012 – (20) (20) Cancelled in2013 – (10) (10) Cancelled in2014 – (20) (20) Share capital at the beginning of theyear 107 423 530 Cancelled in2015 – (10) (10) Sharecapitalattheendoftheyear 107 413 520 At the end of 2015, the share capital amounted to DKK 107 million in A share capital and DKK 413 million in B share capital (equal to 2,063 million B shares of DKK0.20). Basis ofpreparation Results for theyear Operatingassets andliabilities Capital structure and ?nancingitems Otherdisclosures
NOVO NORDISK ANNUAL REPORT2015 80 CONSOLIDATED FINANCIALSTATEMENTS 4.1 SHARE CAPITAL, DISTRIBUTION TO SHAREHOLDERS AND EARNINGS PER SHARE (CONTINUED) TREASURYSHARES Accountingpolicies Treasury shares are deducted from the share capital on cancellation at their nominal value of DKK 0.20 per share. Differences between this amount and the amount paid to acquire or received for disposing of treasury shares are deducted directly in equity. ) ) ) 2015 2014 Numberof Numberof As % of share As % of share Bshares Bshares Marketvalue capitalbefore capitalafter of DKK0.20 of DKK0.20 DKKmillion cancellation cancellation (million) (million) Holding at the beginning of theyear 14,787 2.1% 57 103 Cancellation of treasuryshares (13,015) (1.8%) (50) (100 Holding of treasury shares, adjusted forcancellation 1,772 0.3% 0.3% 7 3 Transfer regarding options and restricted stockunits (242) 0.0% (1) (2 Purchase during theyear 17,229 1.8% 48 59 Sale during theyear (33) (0.1%) (2) (3 Valueadjustment 2,136 – – – Holdingattheendoftheyear 20,862 2.0% 52 57 Treasurysharesareprimarilyacquiredtoreducethecompany’ssharecapital.Inaddition,alimitedpartisusedtofinanceNovoNordisk’slong-termshare-based incentiveprogramme(restrictedstockunits)andrestrictedstockunitstoemployees. NovoNordisk’sguidingprincipleisthatanyexcesscapital,afterthefundingoforganicgrowthopportunitiesandpotentialacquisitions,shouldbereturnedto investors.NovoNordiskappliesapharmaceuticalindustrypayoutratiotodividendpayments,whicharecomplementedbysharerepurchaseprogrammes. Thepurchaseoftreasurysharesduringtheyearrelatestotheremainingpartofthe2014sharerepurchaseprogrammetotallingDKK1.0billionandtheDKK 17.5billionsharerepurchaseprogrammeofNovoNordiskBsharesfor2015,ofwhichDKK1.6billionremainsatyear-end.Theprogrammeendson1February 2016.Transferoftreasurysharesrelatestoexercisedshareoptions,long-termshare-basedincentiveprogrammeandrestrictedstockunitsto employees. Theholdingoftreasurysharesamountsto52,168,703sharesofDKK0.20atyear-end,correspondingtoDKK10millionofthesharecapital(56,807,153shares andDKK11millionofthesharecapitalin2014).Atyear-end,7.2millionsharesoftheholdingoftreasuryBsharesareregardedashedgesforthelong-term share-basedincentiveprogrammeandrestrictedstockunitstoemployees. NETCASHDISTRIBUTIONTOSHAREHOLDERS DKKmillion 2015 2014 2013 Dividends 12,905 11,866 9,715 Sharerepurchases 17,196 14,667 13,924 Total 30,101 26,533 23,639 Attheendof2015,proposeddividends(notyetdeclared)ofDKK16,230million(DKK6.40pershare)areincludedinRetainedearnings.Thedeclareddividend includedinRetainedearningswasDKK12,905million(DKK5.0pershare)in2014andDKK11,866million(DKK4.50pershare)in2013.Nodividendis declaredontreasuryshares. EARNINGS PERSHARE Accountingpolicies Earningspershareispresentedasbothbasicanddilutedearningspershare.Basicearningspershareiscalculatedasnetprofitdividedbytheaveragenumberof sharesoutstanding.Dilutedearningspershareiscalculatedasnetprofitdividedbythesumofaveragenumberofsharesoutstanding,includingthedilutiveeffect oftheoutstandingsharebonuspoolandoptions‘inthemoney’.Pleasereferto‘Financialdefinitions’onp94foradescriptionofthecalculationofthedilutive effect. DKKmillion 2015 2014 2013 Net profit for theyear 34,860 26,481 25,184 Average number of sharesoutstanding in 1,000shares 2,571,219 2,621,226 2,679,362 Dilutive effect of outstanding share bonus pool and options ‘in themoney’ 1 in 1,000shares 6,479 8,992 14,263 Average number of shares outstanding, including dilutive effect of options ‘in the money’ in 1,000shares 2,577,698 2,630,218 2,693,625 Basic earnings pershare DKK 13.56 10.10 9.40 Diluted earnings pershare DKK 13.52 10.07 9.35 1. The dilutive effect has been reduced as the exercise period for options related to the 2006 programme has matured. For further information on the outstanding share bonus pool and options, please refer to note5.1.
NOVO NORDISK ANNUAL REPORT2015 4.2FINANCIALRISKS NovoNordiskhascentralisedmanagementoftheGroup’sfinancialrisks.The overallobjectivesandpoliciesforthecompany’sfinancialriskmanagement areoutlinedinaninternalTreasuryPolicy,whichisapprovedbytheBoardof Directors.TheTreasuryPolicyconsistsoftheForeignExchangePolicy,the InvestmentPolicy,theFinancingPolicyandthePolicyregardingCreditRisk onFinancialCounterparts,andincludesadescriptionofpermittedfinancial instrumentsandrisklimits. NovoNordiskonlyhedgescommercialexposuresandconsequentlydoesnot enterintoderivativetransactionsfortradingorspeculativepurposes.Novo NordiskusesafullyintegratedTreasuryManagementSystemtomanageall financialpositions.Allpositionsaremarked-to-marketbasedonreal-time quotes,andriskisassessedusinggenerallyacceptedstandards. Foreignexchangerisk ForeignexchangeriskistheprincipalfinancialriskforNovoNordiskandas suchhasasignificantimpactontheIncomestatement,Othercomprehensive income,BalancesheetandStatementofcashflows. Theoverallobjectiveofforeignexchangeriskmanagementistoreducethe short-termnegativeimpactofexchangeratefluctuationsonearningsand cashflow,therebyincreasingthepredictabilityofthefinancialresults. ThemajorityofNovoNordisk’ssalesareinUSD,EUR,CNY,JPY,GBPand CAD.Consequently,NovoNordisk’sforeignexchangeriskismostsignificant inUSD,CNYandJPY,whiletheEURexchangerateriskisregardedaslow duetoDenmark’sfixed-ratepolicytowardsEUR. NovoNordiskhedgesexistingassetsandliabilitiesinkeycurrenciesaswell asfutureexpectedcashflowsuptoamaximumof24monthsforward. Hedgeaccountingisappliedtomatchtheimpactofthehedgeditemandthe hedginginstrumentintheconsolidatedincomestatement.Managementhas chosentoclassifytheresultofhedgingactivitiesaspartoffinancialitems. During2015,thehedginghorizonvariedbetween10and13monthsfor USD,CNY,JPY,GBPandCAD.Currencyhedgingisbaseduponexpectations offutureexchangeratesandmainlyusesforeignexchangeforwardsand foreignexchangeoptionsmatchingtheduedatesofthehedgeditems. Expectedcashflowsarecontinuallyassessedusinghistoricalinflows, budgetsandmonthlysalesforecasts.Hedgeeffectivenessisassessedona regularbasis. KEYCURRENCIES Exchange rate DKK per100 2015 2014 2013 USD Average 673 562 562 Year-end 683 612 541 Year-endchange 11.6% 13.1% (4.4%) CNY Average 107 91 91 Year-end 105 99 89 Year-endchange 6.1% 11.2% (2.2%) JPY Average 5.56 5.32 5.77 Year-end 5.67 5.12 5.14 Year-endchange 10.7% (0.4%) (21.8%) GBP Average 1,028 925 878 Year-end 1,011 952 892 Year-endchange 6.2% 6.7% (2.3%) CAD Average 527 509 545 Year-end 492 527 505 Year-endchange (6.6%) 4.4% (11.2%) CONSOLIDATED FINANCIAL STATEMENTS 81 The financial contracts existing at year-end cover the expected future cash flow for the following number ofmonths: 2015 2014 USD 11months 11months CNY 1 11months 11months JPY 12months 13months GBP 12months 11months CAD 11months 11months 1. USD and Chinese yuan traded offshore (CNH) are used as proxies when hedging Novo Nordisk’s CNY currencyexposure. Foreign exchange sensitivityanalysis: A 5% increase/decrease in the following currencies would impact Novo Nordisk’s operating profit as outlined in the tablebelow: DKKmillion Estimatedfor 2016 2015 USD 2,000 1,600 CNY 300 260 JPY 150 115 GBP 85 80 CAD 70 60 Atyear-enda5% increase/decreaseinallothercurrenciesversusEURand DKKwouldaffectthehedginginstruments’impactonOthercomprehensive incomeandtheIncomestatementasoutlinedinthetablebelow: DKKmillion 5%increase inallother currenciesagainst DKK andEUR 5%decrease inallother currenciesagainst DKK andEUR 2015 Other comprehensive income Incomestatement (2,135) 74 2,250 (96) Total (2,061) 2,154 2014 Other comprehensiveincome (1,724) 1,729 Incomestatement 124 (107) Total (1,600) 1,622 Theforeignexchangesensitivityanalysisestimatedfor2016comprises effectsfromtheGroup’sCash,TradereceivablesandTradepayables,Current andnon-currentloans,Currentandnon-currentfinancialinvestments,and ForeignexchangeforwardsandForeignexchangeoptionsatyear-end2015. Anticipatedcurrencytransactions,investmentsandnon-currentassetsare notincluded. Interestraterisk ChangesininterestratesaffectNovoNordisk’sfinancialinstruments.Atthe endof2015,a1percentagepointincreaseintheinterestratelevelwould, allelsebeingequal,resultinadecreaseinthefairvalueofNovoNordisk’s financialinstrumentsofDKK22million(adecreaseinthefairvalueofDKK3 millionin2014). Thefinancialinstrumentsincludedinthesensitivityanalysisconsistof marketablesecuritiesandnon-currentloans.Foreignexchangeforwardsand foreignexchangeoptionsarenotincludedduetothelimitedeffectthata parallelshiftininterestratesinallcurrencieshasontheseinstruments. Liquidityrisk NovoNordiskensurestheavailabilityoftherequiredliquiditythrougha combinationofcashmanagement,highlyliquidinvestmentportfoliosand uncommittedaswellascommittedfacilities.NovoNordiskusescashpools foroptimisationandcentralisationofcashmanagement.
NOVO NORDISK ANNUAL REPORT2015 Inaddition,fullnon-recourseoff-balancesheetfactoringarrangement programmesareoccasionallyappliedbyNovoNordiskaffiliatesaroundthe worldwithlimitedimpactontheGroup’stradereceivables. Please refer to note 2.2 for the split of allowance for trade receivables by geographicalsegment. 4.3 DERIVATIVE FINANCIALINSTRUMENTS Accountingpolicies Use of derivative financial instruments The derivative financial instruments are used to manage the exposure to market risk. None of the derivatives are held fortrading. NovoNordiskusesforwardexchangecontractsandcurrencyoptionsto hedgeforecasttransactions,assetsandliabilities.Currently,netinvestments inforeignsubsidiariesarenothedged. Initial recognition and measurement On initiation of the contract, Novo Nordisk designates each derivative financial contract that qualifies for hedge accounting as oneof: •hedges of the fair value of a recognised asset or liability (fair valuehedge) •hedges of the fair value of a forecast financial transaction (cash flow hedge). All contractsare initiallyrecognisedat fair valueand subsequently remeasuredatfairvalueattheendofthereportingperiod. Gainsandlossesoncurrencyoptionsthatdonotmeetthecriteriaforhedge accountingarerecogniseddirectlyintheIncomestatementunderFinancial incomeorFinancialexpenses. Fairvaluehedges Valueadjustmentsof fairvaluehedgesarerecognisedintheIncome statementalongwithanyvalueadjustmentsofthehedgedassetorliability thatareattributabletothehedgedrisk. Cashflowhedges Valueadjustmentsoftheeffectivepartofcashflowhedgesarerecognised directlyinOthercomprehensiveincome.Thecumulativevalueadjustmentof thesecontractsistransferredfromOthercomprehensiveincometothe IncomestatementunderFinancialincomeorFinancialexpenseswhenthe hedgedtransactionisrecognisedintheIncomestatement.Foroptions,this cumulativevalueadjustmentisreflectedinthevalueoftheoption. Discontinuance ofcashflow hedging Whenahedginginstrumentexpiresorissold,orwhenahedgenolonger meetsthecriteriaforhedgeaccounting,anycumulativegainorloss existinginequityatthattimeremainsinequityandisrecognisedwhenthe forecasttransactionisultimatelyrecognisedintheIncomestatement.When aforecasttransactionisnolongerexpectedtooccur,thecumulativegainor lossthatwasreportedinequityisimmediatelytransferredtotheIncome statementunderFinancialincomeorFinancialexpenses. Fairvaluedetermination Thefairvalueofderivativefinancialinstrumentsismeasuredonthebasisof quotedmarketpricesoffinancialinstrumentstradedinactivemarkets.Ifan activemarketexists,thefairvalueisbasedonthemostrecentlyobserved marketpriceattheendofthereportingperiod. Ifafinancialinstrumentisquotedinamarketthatisnotactive,Novo Nordiskbasesitsvaluationonthemostrecenttransactionprice.Adjustment ismadeforsubsequentchangesinmarketconditions,forinstanceby includingtransactionsin similarfinancialinstrumentsassumedto be motivatedbynormalbusinessconsiderations. Ifanactivemarketdoesnotexist,thefairvalueofstandardandsimple financialinstruments,suchasforeignexchangeforwardcontracts,interest rateswaps,currencyswapsandunlistedbonds,ismeasuredaccordingto generallyacceptedvaluationtechniques.Market-basedparametersareused tomeasurethefairvalue. 82 CONSOLIDATEDFINANCIALSTATEMENTS 4.2FINANCIALRISKS(CONTINUED) Creditrisk Creditriskarisesfromthepossibilitythattransactionalcounterpartiesmay defaultontheirobligations,causingfinanciallossesfortheGroup.Novo Nordiskconsidersitsmaximumcreditriskonfinancialcounterpartiestobe DKK20,769million(2014:DKK15,935million).Inaddition,NovoNordisk considersitsmaximumcreditriskonTradereceivables,Otherreceivablesless prepaymentsandOtherfinancialassetstobeDKK18,202million(2014: DKK15,425million).Pleaserefertonote4.7fordetailsoftheGroup’stotal financialassets. Tomanagecreditriskonfinancialcounterparties,NovoNordiskonlyenters intoderivativefinancialcontractsandmoneymarketdepositswithfinancial counterpartiespossessingasatisfactorylong-termcreditratingfromtwo outofthethreeselectedratingsagencies:StandardandPoor’s,Moody’s andFitch.Furthermore,maximumcreditlinesdefinedforeachcounterparty diversifytheoverallcounterpartyrisk.Thecreditriskonbondsislimitedas investmentsaremadeinhighlyliquidbondswithsolidcreditratings.The tablebelowshowsNovoNordisk’screditexposureoncash,fixed-income marketablesecuritiesandfinancialderivatives. Credit exposure on Cash at bank and on hand, Marketable securities and Derivative financial instruments (market value) Cashat bankand Marketable Derivativ e financi al DKKmillion onhand securities 1 instruments Total 2015 AAA-range 1,027 1,027 AA-range 6,797 2,513 133 9,443 A-range 9,959 171 10,130 BBB-range 101 101 Not ratedor belowBBB-range 66 2 68 Total 16,923 3,542 304 20,769 2014 AAA-range 1,004 1,004 AA-range 6,501 502 20 7,023 A-range 7,641 10 7,651 BBB-range 183 183 Not ratedor belowBBB-range 71 3 74 Total 14,396 1,509 30 15,935 1. Net yield on the bond portfolio is –0.10% (+0.35% in2014). NovoNordiskhasnosignificantconcentrationofcreditriskrelatedtoTrade receivablesorOtherreceivablesandprepayments,astheexposureisspread overa largenumberof counterpartiesand customers. NovoNordisk continuestomonitorthecreditexposureinRegionInternationalOperations duetotheincreasingsalesandlowcreditratingsofmanycountriesinthis region. Tradereceivableprogramme NovoNordisk’sJapaneseandUS subsidiariesemploytradereceivable programmeswheretradereceivablesaresoldonafullnon-recoursetermto optimiseworkingcapital. At year-end, the Group had derecognised receivables without recourse having due dates after 31 December amountingto: DKKmillion 2015 2014 2013 Japan US 1,899 945 1,669 0 1,685 0 InDecember2015NovoNordiskinitiatedtheprogrammeintheUS.The programmeisexpectedtogrowinsizeoverthecomingyear,whenafullyear oftradereceivableswillbecovered.
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 83 4.3 DERIVATIVE FINANCIAL INSTRUMENTS(CONTINUED) HEDGINGACTIVITIES DKKmillion 2015 Contract Positive Negative amount fair value fairvalue atyear-end atyear-end atyear-end 2014 Contract Positive Negative amount fair value fairvalue atyear-end atyear-end atyear-end Forward contracts, cash flow hedges Currencyoptions, cash flow hedges 1 Forwardcontracts, fairvalue hedges 41,630 202 911 5,533 66 – 2,753 59 471 32,095 10 2,252 2,429 29 – 3,490 – 355 Total hedging activities 49,916 327 1,382 38,014 39 2,607 Total fair value adjustments recognised in the Incomestatement 102 471 8 355 Total fair value adjustments recognised inOther comprehensive income 2 225 911 31 2,252 Presented in the Balance sheetas: Derivative financial instruments (currentassets) 304 30 Derivative financial instruments (current liabilities) 1,382 2,607 Cash atbank 23 9 1.Includes expired currency options of DKK 23 million deferred for realisation in 2016. 2.Realisation in 2015 of previously deferred loss amounts to DKK 2,216 million as the remaining DKK 5 million was not realised until 2016. Furthermore, an additional loss of DKK 681 million per 31 December 2015 is deferred for realisation in2016. HEDGINGOFFORECASTTRANSACTIONS (CASHFLOWHEDGE) DKKmillion Contract amount atyear-end 2015 Positive fairvalue atyear-end Negative fairvalue atyear-end Contract amount atyear-end 2014 Positive fairvalue atyear-end Negative fairvalue atyear-end Hedging of forecast transactions qualifying for hedge accounting USD CNH, JPY, GBP and other currencies 34,279 7,351 85 117 819 92 26,540 5,555 – 10 2,252 – Total forward contracts (forecast cash flow) USD JPY 41,630 5,285 248 202 20 3 911 – – 32,095 2,051 378 10 – 21 2,252 – – Total currency options (forecast cash flow) 5,533 23 – 2,429 21 – Total cash flow hedges for which hedge accounting isapplied 47,163 225 911 34,524 31 2,252 Other forecast transaction hedges for which hedge accounting is notapplied Currency options for which hedge accounting is notapplied – 43 – – 8 – Total contracts for forecasttransactions 47,163 268 911 34,524 39 2,252 The above financial contracts are expected to impact the Income statement within the periods shown below. The split is based on an estimate of when the cash flow hedges are expected to be reclassified to fair value hedges, and the fair value thereby transferred to Financial income or Financial expenses. 201 5 2014 Positive Negative Positive Negative DKKmillion fairvalue atyear-end fairvalue atyear-end fairvalue atyear-end fairvalue atyear-end Expected timing of Income statementimpact 0–12months 225 907 28 2,251 More than 12months – 4 3 1 Total cash flow hedges for which hedge accounting isapplied 225 911 31 2,252
NOVO NORDISK ANNUAL REPORT2015 4.4 CASH AND CASH EQUIVALENTS, FINANCIAL RESOURCES AND FREE CASH FLOW Accountingpolicies The Statement of cash flows shows how income and changes in balance sheet items affect cash and cash equivalents, iethe cash generated orused intheperiod. Cash from operating activities converts income statement items from the accrual basis of accounting tocash basis. Assuch, starting with net profit, non-cash items are reversedand actual payments included. Further,change inworking capital istaken into account as this shows the development in money tied up in the balance sheet. Cash from investing activities shows payments related to the purchase and sale of NovoNordisk’slong- term investments. This includes fixed assets such as construction of new production sites, intangible assets such aspatents and licences, and financial assets. Cash from financing activities reports purchase and sale of Novo Nordisk’sownsharesand payment ofdividends. Cash and cash equivalents consist of cash offset by short-term bank loans. Financial resourcesconsistofcash and cash equivalents, marketable securities with original maturity of less than three months and undrawn committed credit facilities expiring after more than one year. The Statement of cash flows ispresented inaccordance withtheindirectmethod commencing with Netprofitfortheyear.Cashflows inforeign currenciesaretranslated toDKK attheaverage exchange ratefortherespectivemonth. ) 1.Theundrawn committed creditfacilityin2015 isaEUR1,100millionfacility(EUR1,100 millionin2014 and EUR650 millionin2013)committed byaportfolioofinternational banks.Thefacilitymaturesin2019. DKKmillion 2015 2014 2013 CASHANDCASHEQUIVALENTS Cash at bank and on hand(note 4.2) 16,923 14,396 10,728 Current debt (bank overdrafts) (1,073) (720) (215 Cash and cashequivalents attheendoftheyear 15,850 13,676 10,513 FINANCIALRESOURCES Cash and cashequivalents 15,850 13,676 10,513 Marketable securities (note4.2) 3,542 1,509 3,741 Undrawn committed creditfacility 1 8,209 8,188 4,849 Total financialresources 27,601 23,373 19,103 84 CONSOLIDATED FINANCIALSTATEMENTS 4.3 DERIVATIVE FINANCIAL INSTRUMENTS(CONTINUED) HEDGINGOFASSETSANDLIABILITIES(FAIRVALUEHEDGE) DKKmillion Contract amount atyear-end at 2015 Positive fair value year-end at Negative fair value year-end Contract amount atyear-end at 2014 Positive fair value year-end at Negative fair value year-end USD 1,891 42 400 2,367 – 333 JPY, GBP and othercurrencies 862 17 71 1,123 – 22 Total fair valuecontracts 2,753 59 471 3,490 – 355 Thetable above shows the fair value of fair value-hedging activities for 2015 and 2014. Value adjustments of fair value hedges are recognised in Financial income and Financial expenses along with any value adjustments tothe hedged asset orliability that are attributable tothe hedged risk.Thechanges in fair values recognised intheIncome statement amount toa netlossofDKK412 millionin2015 (anetlossofDKK355 millionin2014). Theportfolio of fair value hedges also includes the recycledfair value of cash flow hedges as the hedged transactions arerecognised as assets orliabilities at year-end. Thefinancial contracts existing at year-end hedge the currencyexposure on assets and liabilities in the Group’smajor currenciesexcluding DKKand EUR.The contractamounts of othercurrenciesatyear-endareJPY atDKK91 million (DKK310 million in2014),GBPat DKK329 million (DKK313 million in2014),and ‘other’comprising CADatDKK190 million(DKK444 millionin2014)and AUDatDKK252 million(DKK56 millionin2014). FREE CASHFLOW ) ) DKKmillion 2015 2014 2013 Net cash generated from operating activities Net cash used in investing activities Net purchase of marketable securities 38,287 (6,098) 2,033 31,692 25,942 (2,064) (2,773 (2,232) (811 Free cashflow 2 34,222 27,396 22,358 2. Additional non-IFRS measure; please refer to p 94 fordefinitions. 4.5 CHANGE IN WORKING CAPITAL Accountingpolicies Working capital is defined as current assets less current liabilities and measures the liquid assets Novo Nordisk has available for thebusiness. CHANGEINWORKING CAPITAL ) ) ) DKKmillion 2015 2014 2013 Inventories (1,401) (1,805) (9 Tradereceivables (2,444) (2,134) (1,268 Other receivables and prepayments 493 (296) 251 Tradepayables (23) 858 233 Otherliabilities 1,604 1,665 404 Adjustment for the partial divestment of NNITA/S (207) – – Change in workingcapital before exchange rateadjustments (1,978) (1,712) (389 Exchange rateadjustments (179) (436) 124 Cash flow change in workingcapital (2,157) (2,148) (265 )
NOVO NORDISK ANNUAL REPORT2015 Unrealisedgains and lossesarising fromchanges inthefair value offinancial assets classified as available for sale are recognised in Othercomprehensive income. When financial assets classified as available for sale are sold or impaired, theaccumulated fair value adjustments areincluded intheIncome statement. The fair values of quoted investments (including marketable securities) are based on current bid prices at the end of the reporting period. Financial assets forwhich noactive market existsarecarriedatfair value based on a valuation methodology or at cost if no reliable valuation model can be applied. Loansandreceivables Loans and receivables are non-derivative financial assets with fixed or determinable payments that arenotquoted inan activemarket.Ifcollection isexpected within oneyear(orinthenormal operating cycleofthebusiness if longer), they areclassified as Currentassets.If not, they arepresented as Non-currentassets. Tradereceivables and Otherreceivables are recognised initially at fair value and subsequently measured at amortised cost using the effective interest method, less provision for allowance. Provision for allowance is made for Tradereceivables when there is objective evidence that NovoNordiskwill notbeable tocollectallamounts due according totheoriginal termsof the receivables. Theprovision for allowance is deducted from the carrying amount of Trade receivables, and the amount of the loss is recognised in the Income statement under Sales and distribution costs. When a trade receivable is uncollectible, it is written off against the allowance account for trade receivables. Subsequent recoveries of amounts previously written off are creditedagainst Sales and distribution costsintheIncomestatement. 4.7 FINANCIAL ASSETS ANDLIABILITIES Accountingpolicies Depending on the purpose of each investment, Novo Nordisk classifies these into the following categories: • Available-for-sale financial assets • Loans and receivables • Financial assets at fair value through the Income statement (derivatives). Management determines the classification of its investments on initial recognition and re-evaluates thisat the end of everyreporting periodtothe extentthat sucha classification ispermitted and required. Recognition and measurement Purchases and sales of investments are recognised on the settlement date. Investments are initially recognised at fair value. Available-for-sale financial assets and financial assets at fair value are subsequently carried at fair value. Loans and receivables are carried at amortised costbased ontheeffective interestmethod. Fair value disclosures are made separately for each class of financial instruments at the end of the reportingperiod. Disposalofinvestments Investments areremoved from the balance sheet when the rights toreceive cash flows from the investments have expired or have been transferred, and NovoNordiskhas transferred substantially all the risksand rewards of ownership. Available-for-salefinancialassets Available-for-sale financial assets consist of equity investments and market- able securities. Equity investments are included in Other financial assets unless Management intends todispose of the investment within 12 months of the end of the reporting period. If that is the case, the current part is included inOtherreceivablesand prepayments. CONSOLIDATED FINANCIAL STATEMENTS 85 4.6 OTHER NON-CASHITEMS Forthepurposeofpresenting theStatement ofcashflows, non-cashitemswitheffect ontheIncomestatement mustbereversed toidentify theactual cashflow effect from the Income statement. The adjustments are specified asfollows: OTHER NON-CASHITEMS DKKmillion 2015 2014 2013 Reversals of non-cash income statement items Interest income and interest expenses, net (note4.9) 11 (62) (1) Share-based payment costs (note5.1) 442 371 409 Changes in non-cash balance sheet items Increase/(decrease) in provisions (note 3.6) 6,193 3,138 930 Increase/(decrease) in retirement benefit obligations (note 3.5) 155 343 (72) Remeasurements of retirement benefit obligations (note 3.5) (37) (247) 54 Otheradjustments (Gains)/losses from sale of property, plant and equipment (2) 1 (1) Result of associated company (note4.8) (14) – (17) Exchange rate adjustments on working capital 179 436 (124) Other, primarily exchange rate adjustment of provisions etc (1,019) 183 (594) Total other non-cashitems 5,908 4,163 584
NOVO NORDISK ANNUAL REPORT2015 86 CONSOLIDATED FINANCIALSTATEMENTS 4.7 FINANCIAL ASSETS AND LIABILITIES(CONTINUED) FINANCIAL ASSETS BYCATEGORY Financial assets Available- measuredat for-sale fairvalue financial throughthe Loans Cash DKKmillion assetsat fairvalue Income statement and receivables andcash equivalents Total 2015 Other financialassets 737 602 1,339 Trade receivables (note3.4) 15,485 15,485 Otherreceivables 2,257 2,257 –lessprepayments (879) (879) Marketable securities (bonds) (note4.2) 3,542 3,542 Derivative financial instruments (note4.3) 304 304 Cash at bank and on hand (note4.4) 16,923 16,923 Totalfinancial assetsattheendoftheyearbycategory 1 4,279 304 17,465 16,923 38,971 Total financial assets at the end of the year by category, 2014 1,875 30 15,029 14,396 31,360 FINANCIAL LIABILITIES BYCATEGORY Financial Financial liabilities liabilities measuredat Financial measuredat fairvalue liabilities fairvalue throughthe measuredat throughOther DKKmillion Income statement amortised cost comprehensive income Total 2015 Current debt (note4.4) 1,073 1,073 Tradepayables 4,927 4,927 Other liabilities (note3.7) 12,655 12,655 –less VAT and duties payable (note3.7) (896) (896) Derivative financial instruments (note4.3) 1,382 1,382 Totalfinancial liabilities attheendoftheyearbycategory 1 1,382 17,759 – 19,141 2014 Current debt (note4.4) 720 720 Tradepayables 4,950 4,950 Other liabilities (note3.7) 11,051 11,051 –less VAT and duties payable (note3.7) (744) (744) Derivative financial instruments (note4.3) 2,607 2,607 Total financial liabilities at the end of the year by category 1 2,607 15,977 – 18,584 1. All financial assets and liabilities are due within oneyear. For a description of the credit quality of financial assets such as Trade receivables, Cash at bank and on hand, Marketable securities, Current debt and Derivative financial instruments, refer to notes 4.2 and4.3. FAIR VALUE MEASUREMENTHIERARCHY DKKmillion 2015 2014 Active marketdata 4,279 1,870 Directly or indirectly observable marketdata 304 30 Not based on observable marketdata – 5 Totalfinancial assetsatfairvalue 4,583 1,905 Active marketdata – – Directly or indirectly observable marketdata 1,382 2,607 Not based on observable marketdata – – Total financial liabilities at fairvalue 1,382 2,607 Financialassetsandliabilitiesmeasuredatfairvaluecanbecategorisedusingthefairvaluemeasurementhierarchyabove.Therehavenotbeenanytransfers betweenthecategories’Activemarketdata’and’Directlyorindirectlyobservablemarketdata’during2015or2014.Therearenointangibleassetsoritemsof property,plantandequipmentmeasuredatfairvalue.
NOVO NORDISK ANNUAL REPORT2015 4.8 INVESTMENT IN ASSOCIATED COMPANY Accounting policies Investmentsinassociatedcompanies AnassociatedcompanyisanentityinwhichNovoNordiskhassignificant influence,butnotcontrol,whichingeneralwillbewhenholding20%to 50%ofthevotingrights.Suchinvestmentisaccountedforusingtheequity methodofaccounting.TheinvestmentisadjustedbyNovoNordisk’sshareof theresultsaftertaxoftheassociatedcompany. NovoNordisk’sshareoftheresultsisrecognisedintheIncomestatementas financialitemsi.e.outsideoperatingprofit.Theshareofresultswill be recognisedbasedon theassociatedcompany’sfull-yearoutlook,with adjustmentforactualfull-yearresultinthefirstquarterofthefollowingyear. retainedequityinterestintheentityisrevaluedatfairvalueonthedate INITIAL FAIR VALUE OF RETAINED INVESTMENT IN NNITA/S DKKmillion 2015 Carrying amount of 25.5% of net assets in NNIT A/S Fair value revaluation of retainedinvestment 153 644 Initialfairvalueofinvestmentinassociatedcompany 797 The market value at 31 December 2015 of shareholdings in NNIT A/S amounts to DKK 1,202 million, based on a list price of DKK189. DKKmillion 2015 Carrying amount of investment at the beginning of theperiod – Additions during theperiod 797 Share of profit/(loss), recognised in the Incomestatement 48 Amortisation of intangibleassets (34) Carryingamount ofinvestment attheendoftheyear 811 CONSOLIDATED FINANCIAL STATEMENTS 87 4.9FINANCIALINCOMEANDEXPENSES Accounting policies Asdescribedinnote4.2,Managementhaschosentoclassifytheresultof hedgingactivitiesaspartof financialitemsin theIncomestatement. Financialitemsareprimarilyrelatedtoforeignexchangeelementsandare mainlyimpactedbythecumulativevalueadjustmentofcashflowhedges transferredfromOthercomprehensiveincometotheIncomestatement whenthehedgedtransactionisrecognisedintheIncomestatement.Further, valueadjustmentsoffairvaluehedgesarerecognisedinFinancialincome andFinancialexpensesalongwithanyvalueadjustmentsofthehedgedasset orliabilitythatareattributabletothehedgedrisk.Finally,valueadjustments ofassetsandliabilitiesinnon-hedgedcurrencieswillimpactFinancialincome andFinancialexpenses. FINANCIALINCOME DKKmillion 2015 2014 2013 Interestincome 56 101 56 Financial gain fromforward contracts(net) – – 1,631 Financial gain fromcurrency options(net) – 32 – Capital gain on investmentsetc 15 34 – Financial gain/(loss) fromother financialassets – – 15 Result of associatedcompany 14 Total financial income 85 167 1,70 2 Disposal ofsubsidiaries WhenNovoNordiskceasestohavecontroloverasubsidiary,theassets and liabilities of the subsidiary are removed from the Balance sheet. Any when control is lost with the revaluation gain or loss being recognised inthe Incomestatement. The fair value revaluation is allocated to the entity’s identifiable assets and liabilities, and any excess value is recognised as goodwill. The identified assets are amortised over their estimated useful life, and goodwill is subject to impairmenttesting. INVESTMENT IN ASSOCIATEDCOMPANY FINANCIALEXPENSES DKKmillion Interestexpenses 2015 67 2014 39 2013 55 Foreign exchange loss(net) 1 504 288 435 Financial loss fromforward contracts(net) 5,232 125 – As a result of Novo Nordisk A/S’s divestment of 74.5% of the shares in NNIT Financial loss fromcurrency A/Son6March2015,NNITA/Shaschangedstatusfromasubsidiarytoan options(net) 162 – 50 associatedcompanyofNovoNordiskA/S.Atthetimeofthedisposal,the Capital loss on investmentsetc – – 20 retained investment of 25.5% was revalued at fair value based on an active Other financialexpenses 81 111 96 market price of DKK 125 per share. The revaluation value was allocated to identifiable assets such as order backlog and customer relationships, andthe Total financial expenses 6,046 563 656 remaining part is classified asgoodwill. 1. Primarily related to trade receivables, other receivables and tradepayables. FINANCIAL IMPACT FROM FORWARD CONTRACTS AND CURRENCY OPTIONS,SPECIFIED DKKmillion 2015 2014 201 3 Forwardcontracts Transferred from Othercomprehensive income (2,237) 1,104 809 Value adjustment oftransferred contracts (3,212) (1,160) 678 Foreign exchange gain/loss onforward contracts 217 (69) 144 Financial income/(expense) from forward contracts (5,232) (125) 1,63 1 Currencyoptions Transferred from Othercomprehensive income 21 125 – Value adjustment of transferredoptions (12) (12) 2 5 Foreign exchange gain/loss oncurrency options (171) (81) (7 5 Financial income/(expense) from currencyoptions (162) 32 (5 0 ) )
NOVO NORDISK ANNUAL REPORT2015 88 CONSOLIDATED FINANCIALSTATEMENTS SECTION 5 OTHERDISCLOSURES This section provides details on notes that are statutory or by their nature of secondary importance for understanding the financial performance of Novo Nordisk. A list of subsidiaries in the Novo Nordisk Group is also included here. Long-term share-based incentiveprogramme For a description of the programme, please refer to ‘Remuneration’ in ‘Governance, leadership and shares’, pp 49–51. SeniorManagement Board On2February2016,theBoardofDirectorsapprovedtheestablishment,ofa jointpoolforthefinancialyear2015byallocatingatotalof378,943Novo NordiskBshares.Thisallocationamountsonaverageto12months’fixed basesalarypluspensioncontributionfortheCEO,9months’fixedbase salarypluspensioncontributionpermemberofExecutiveManagementas per1March2015and8months’fixedbasesalaryforSeniorVicePresidents, correspondingtoavalueatlaunchoftheprogrammeofDKK108million. Thisamountwasexpensedin2015.Thesharepriceusedfortheconversion wastheaverageshareprice(DKK285) forNovoNordiskB shareson NASDAQCopenhagenintheperiod30January–13February2015. Based on the splitof participantswhen the joint pool was established, approximately50%ofthepoolwillbeallocatedtomembersofExecutive Managementand50%toothermembersoftheSeniorManagementBoard. Thesharesallocatedto thejointpoolfor2012werereleasedtothe individualparticipantssubsequenttotheapprovaloftheAnnualReport 2015bytheBoardofDirectorsandaftertheannouncementofthe2015full- yearfinancialresultson3February2016.Thesharesallocatedcorrespondto avalueatlaunchoftheprogrammeofDKK73million,expensedin2012. period 2012–2015. The number of shares to be transferred (1,355,153 pool as some participants had left the company before the release conditions of the programme weremet. Basis ofpreparation Results for theyear Operatingassets andliabilities Capital structure and ?nancingitems Otherdisclosures 5.1SHARE-BASEDPAYMENTSCHEMES Accountingpolicies Share-basedcompensation NovoNordiskoperatesequity-settled,share-basedcompensationplans.The fairvalueoftheemployeeservicesreceivedinexchangeforthegrantofthe optionsorsharesisrecognisedasanexpenseandallocatedoverthevesting period. Thetotalamounttobeexpensedoverthevestingperiodisdeterminedby referencetothefairvalueoftheoptionsorsharesgranted,excludingthe impactofanynon-marketvestingconditions.Thefairvalueisfixedatthe grantdate.Non-marketvestingconditionsareincludedinassumptions aboutthenumberofoptionsorsharesthatareexpectedtovest.Attheend ofeachreportingperiod,NovoNordiskrevisesitsestimatesofthenumber ofsharesexpectedtovest.NovoNordiskrecognisestheimpactoftherevision of the originalestimates,if any,in the Incomestatementand in a correspondingadjustmenttoEquity(changeinproceeds)overtheremaining vestingperiod.AdjustmentsrelatingtoprioryearsareincludedintheIncome statementintheyearofadjustment. SHARE-BASEDPAYMENT Expensed in the Incomestatement Management group below Senior Management Board DKKmillion 2015 2014 2013 The management group below the Senior Management Board has a Restricted stock units toemployees 135 141 188 share-based incentive programme with similar performance criteria.For 2015, a total of 879,988 shares were allocated to the pool for this group Long-term share-basedincentive corresponding to a value at launch of the programme of DKK 251million. programme (SeniorManagement Board) 1 108 66 51 The shares allocated to the pool for 2012 were released to the individual Long-term share-basedincentive participants subsequent to the approval of the Annual Report 2015 by programme (managementgroupbelow the Board of Directors and after the announcement of the 2015full-year SeniorManagementBoard) 2 199 164 170 financial results on 3 February 2016. The shares allocated correspond to a Share-based paymentexpensed valueatlaunchoftheprogrammeofDKK234millionamortisedoverthe in the Incomestatement 442 371 409 shares) is lower than the original number of shares allocated to the share 1.Expense for the year reflects the full value at launch of the programme for theyear. 2.Expense for the year reflects the value at launch of the last four programmes, amortised over fouryears. Restrictedstockunitstoemployees Followingthe90thanniversaryin2013,allemployeesinthecompany(excl NNEPharmaplan)wereoffered100restrictedstockunits.Arestrictedstock unitgivestherighttoreceiveoneNovoNordiskBsharefreeofchargeon1 April2016subjecttocontinuedemploymentandaveragesalesgrowthofat least5% peryearmeasuredinDKKintheperiod2012–2015.Thecostof theDKK440millionprogrammeisamortisedovertheperiod2013–2016at anannualamountofDKK135million. Asthesalesgrowthhasbeen achieved,theshareswillbegrantedtotheemployeeson1April2016.
NOVO NORDISK ANNUAL REPORT2015 ) ) EXERCISABLE SHAREOPTIONS 2015 2014 Exercisable at the beginning of theyear 955,570 2,801,920 Exercised (930,570) 1 (1,787,350 Cancelled (25,000) (59,000 Exercisableattheendoftheyear 0 955,570 2 1.Forexercisedshareoptions, theaverage marketpriceofNovoNordisk Bsharesforthe trading period 30 January to 13 February 2015 was DKK 285per share. 2.Average exercise price per option (excluding restricted stock units) amounted to DKK 35 in 2014, and calculated fair value per option amounted to DKK 225 in2014. Valueat OUTSTANDINGRESTRICTED STOCKUNITS Issued 1 Released 2 Cancelled (accumulated) Outstanding launch date DKKmillion Vestingdate Restricted stock units toemployees 2013 Restricted stockunits 2,370,000 – – 2,370,000 1/04/16 Outstanding restricted stock unitsto employees at the end of2015 2,370,000 – – 2,370,000 Shares allocated to jointpools for Senior ManagementBoard 2011 Shares allocated to jointpool 448,560 (448,560) – 0 57 Q12015 2012 Shares allocated to jointpool 487,730 (10,435) – 477,295 73 Q12016 2013 Shares allocated to jointpool 254,513 (8,993) – 245,520 51 Q12017 2014 Shares allocated to jointpool 293,044 (9,369) – 283,675 66 Q12018 2015 Shares allocated to jointpool 3 378,943 378,943 108 Q12019 Outstanding shares in joint poolfor Senior Management Board 1,862,790 (477,357) – 1,385,433 Shares allocated topools for management groupbelow Senior ManagementBoard 2011 Shares allocated topool 1,485,665 (1,329,080) (156,585) 0 188 Q12015 2012 Shares allocated topool 1,559,235 (35,160) (168,922) 1,355,153 234 Q12016 2013 Shares allocated topool 622,190 (22,620) (54,701) 544,869 126 Q12017 2014 Shares allocated topool 683,728 (34,061) (26,474) 623,193 155 Q12018 2015 Shares allocated topool 3 879,988 – – 879,988 251 Q12019 Outstanding shares in pool for management group below Senior Management Board 5,230,806 (1,420,921) (406,682) 3,403,203 Outstandingattheendof2015 9,463,596 (1,898,278) (406,682) 7,158,636 1.All restricted stock units and shares allocated to Management pools are hedged by treasury shares. 2.Released shares from 2012 to 2014 Management pools relates to NNIT A/S employees following the Initial Public Offering of NNIT A/S. 3.2015 programme released subsequent to approval of the Annual Report 2015 on 2 February 2016. The programme includes former members of Senior Management Board with a total value of DKK 16.2 million. CONSOLIDATED FINANCIAL STATEMENTS 89 5.1 SHARE-BASED PAYMENT SCHEMES(CONTINUED) OUTSTANDINGRESTRICTED ) ) ) STOCKUNITS 2015 2014 Outstanding at the beginning of theyear 7,960,080 10,528,372 Released restricted stock units toemployees 0 (24,500 Released shares from 2011 Management pools 1 (1,787,640) (3,341,692 Released shares from 2012–2014 management pools 2 (120,638) Cancelled shares from Management pool 1 (152,097) (178,872 Shares allocated to Management pools 1,258,931 976,772 Outstandingattheendoftheyear 7,158,636 7,960,080 1.Includes 10,000 shares released and 2,190 shares cancelled related to Management pools from previous years. 2.Realised 2012–2014 programme following the partial divestment of NNIT A/S.
NOVO NORDISK ANNUAL REPORT2015 90 CONSOLIDATED FINANCIALSTATEMENTS 5.2 MANAGEMENT’S HOLDINGS OF NOVO NORDISKSHARES The internal rules for trading in Novo Nordisk securities by board members, executives and certain employees only permit trading in the 15-calendar-day period following each quarterlyannouncement. MANAGEMENT’S HOLDING OFSHARES At thebeginning of theyear 1 Addition s during the year Sold/transferr ed during the year At theend of theyear Marketvalue 2 DKKmillion GöranAndo 13,000 13,000 5.2 BrunoAngelici 2,500 2,500 1.0 JeppeChristiansen – 3,529 3,529 1.4 LizHewitt 2,725 2,725 1.1 LiselotteHyveled 3,855 2,030 (937) 4,948 2.0 Thomas PaulKoestler 16,000 2,000 18,000 7.2 Anne MarieKverneland 11,099 (628) 10,471 4.2 SylvieGrégoire – 875 875 0.3 Søren ThuesenPedersen 1,615 1,615 0.6 EivindKolding – 3,850 3,850 1.5 StigStrøbæk 1,950 1,950 0.8 MarySzela – 935 935 0.4 Board of Directors intotal 52,744 13,219 (1,565) 64,398 25.7 Lars RebienSørensen 354,850 37,515 392,365 156.9 JesperBrandgaard 186,205 25,010 (25,010) 186,205 74.5 Maziar MikeDoustdar 13,815 4,065 17,880 7.2 Lars FruergaardJørgensen 95,855 12,505 (7,000) 101,360 40.5 JerzyGruhn 2,600 47,505 (4,500) 45,605 18.2 JesperHøiland 60,015 12,505 72,520 29.0 JakobRiis 72,145 12,505 84,650 33.9 Mads KrogsgaardThomsen 279,135 26,830 (25,610) 280,355 112.1 HenrikWulff 64,105 12,505 (2,800) 73,810 29.5 Executive Management in total 1,128,725 190,945 (64,920) 1,254,750 501.8 Other members of the Senior ManagementBoard 554,337 242,570 (95,690) 701,217 280.4 Joint pool for Executive Managementand other members of the Senior ManagementBoard 3 1,110,309 329,309 (347,898) 1,091,720 4 436.6 Total 2,846,115 776,043 (510,073) 3,112,085 1,244.5 1.FollowingthechangeintheBoardofDirectorsandtheretirementofmembersofExecutiveManagementandtheSeniorManagementBoard,theholdingofsharesatthebeginningof theyearhasbeenupdatedcomparedwiththeAnnualReport2014. 2.Calculation of the market value is based on the quoted share price of DKK 399.90 at the end of the year. 3.Theannualallocationtothejointpoolislockedupforthreeyearsbeforeitistransferredtotheparticipantsemployedattheendofeachthree-yearperiod.Basedonthesplitof participantswhenthejointpoolwasestablished,approximately50%ofthepoolwillbeallocatedtothemembersofExecutiveManagementandapproximately50%toother membersoftheSeniorManagementBoard.Inthelock-upperiod,thejointpoolmaypotentiallybereducedintheeventoflower-than-plannedvaluecreationinsubsequentyears. 4.Jointpoolincludesthe2012programmereleasedon2February2016andexcludes293,713sharesassignedtoretiredExecutiveManagementandSeniorManagementBoard members.
NOVO NORDISK ANNUAL REPORT2015 5.3COMMITMENTS Commitments Total contractual obligations and recognised non-current debt can be specified as follows (payments due byperiod): 2015 More DKKmillion Within 1year 1–3 years 3–5 years than 5years Total Retirement benefit obligations 71 134 118 863 1,186 Total non-current liabilities recognised in the Balancesheet 71 134 118 863 1,186 Operatingleases 1 1,084 1,631 1,248 2,390 6,353 Purchaseobligations 4,421 1,769 795 112 7,097 Research anddevelop- mentobligations 1,586 691 180 – 2,457 Totalobligations not recognised in the Balancesheet 7,091 4,091 2,223 2,502 15,907 Totalcontractual obligations 7,162 4,225 2,341 3,365 17,093 2014 Within 1–3 3–5 Mor e tha n DKKmillion 1year years years 5years Total Retirementbenefit obligations 52 98 88 793 1,031 Totalnon-current liabilitiesrecognised in the Balancesheet 52 98 88 793 1,031 Operatingleases 1 1,060 1,613 1,260 2,356 6,289 Purchaseobligations 2,175 1,551 1,061 – 4,787 Research anddevelop- mentobligations 1,896 1,490 305 – 3,691 Totalobligations not recognised inthe Balancesheet 5,131 4,654 2,626 2,356 14,767 Totalcontractual obligations 5,183 4,752 2,714 3,149 15,798 1. No material finance lease obligations exist in 2015 and2014. CONSOLIDATED FINANCIAL STATEMENTS 91 The operating lease commitmentsare related to non-cancellable operatingleasesprimarilyforpremises,companycarsandofficeequipment. Approximately78% of thecommitmentsarerelatedtoleasesoutside Denmark.Theleasecostsfor2015and2014wereDKK1,293millionand DKK1,310millionrespectively. Thepurchaseobligationsprimarilyrelatetopurchaseagreementsregarding medicalequipmentandconsumergoods.NovoNordiskexpectstofund thesecommitmentswithexistingcashandcashflowfromoperations. Researchanddevelopmentobligationsentailuncertaintiesinrelationtothe periodinwhichpaymentsareduebecauseaproportionoftheobligations aredependentonmilestoneachievements.Thedueperiodsdisclosedare basedon Management’sbestestimate. NovoNordiskhasengagedin researchanddevelopmentprojectswithanumberofexternalenterprises. Mostoftheseobligationsrelatetothecardiovascularoutcomesstudyfor Tresiba ® ,theDEVOTEprogramme. DKKmillion 2015 2014 Other guarantees Other guarantees primarily relate toguarantees 748 960 issued by Novo Nordisk in relation torented property Security fordebt 78 237 Land, buildings and equipment etc at carrying amount World Diabetes Foundation (WDF) AttheAnnualGeneralMeetingin2008,anewdonationwasagreedto by theshareholders.Accordingtothisagreement,NovoNordiskisobligedto makeannualdonationstotheFoundationintheperiod2011–2017of 0.125%ofthenetinsulinsalesoftheGroupintheprecedingfinancialyear. Theannualdonationintheperiod2012–2017willnotexceedthelowerof DKK80millionor15%ofthetaxableincomeofNovoNordiskA/Sinthe financialyearinquestion. In2015,thedonationamountstoDKK78million(DKK66millionin2014 andDKK64millionin2013),whichisrecognisedinAdministrativecostsin theIncomestatement. Disclosure regarding change ofcontrol TheEUTakeoverBidsDirective,aspartiallyimplementedbytheDanish FinancialStatementsAct,containscertainrulesrelatingtolistedcompanies ondisclosureofinformationthatmaybeofinteresttothemarketand potentialtakeoverbidders,inparticularinrelationtodisclosureofchange ofcontrolprovisions. Thecompany’sAsharesarenotlistedandareheldbyNovoA/S,aDanish publiclimitedliabilitycompanywhollyowned by the NovoNordisk Foundation.AccordingtotheArticlesofAssociationoftheFoundation,the Asharescannotbedivested.Forinformationontheownershipstructureof NovoNordisk,pleasereferto‘Sharesandcapitalstructure’onpp44–45. Forinformationonchangeofcontrolclausesinshareoptionprogrammes, pleaserefertonote5.1,‘Share-basedpaymentschemes’,andinrelationto employeecontractsforExecutiveManagementofNovoNordisk,pleaserefer to‘Remuneration’onpp49–51. Inaddition,NovoNordiskdisclosesthattheGroupdoesnothaveany significantagreementstowhichtheGroupisapartyandwhichtakeeffect, alteror terminateupona changeof controlof theGroupfollowing implementationofatakeoverbid.
NOVO NORDISK ANNUAL REPORT2015 5.5 FEE TO STATUTORYAUDITORS DKKmillion 2015 2014 2013 Statutoryaudit 24 24 24 Audit-relatedservices 4 4 4 Tax advisoryservices 8 8 11 Otherservices 7 11 5 Total fee to statutory auditors 43 47 4 4 92 CONSOLIDATEDFINANCIALSTATEMENTS 5.4RELATEDPARTYTRANSACTIONS NovoNordiskA/SiscontrolledbyNovoA/S(incorporatedinDenmark),which owns27.0%ofthesharecapitalinNovoNordiskA/S,representing75.0% ofthetotalnumberofvotes,excludingtreasuryshares.Theremaining sharesarewidelyheld.TheultimateparentoftheGroupistheNovoNordisk Foundation(incorporatedinDenmark).Bothentitiesareconsideredrelated parties. BeinganassociatedcompanyofNovoNordiskA/S,NNITA/Sisconsidereda relatedparty.OtherrelatedpartiesareconsideredtobetheNovozymes GroupandXelliaPharmaceuticalsdueto jointownership,associated companiesandManagementofNovoNordiskA/S. NovoNordiskA/SdidnotacquirenewBsharesfromNovoA/Sin2014or 2015. In2013,NovoNordiskA/Sacquired12,750,000Bshares,worthDKK2.5 billion,fromNovoA/SaspartoftheDKK14.0billionsharerepurchase programme. ThetransactionpricewasDKK196.4 pershareandwas calculatedastheaveragemarketpricefrom1Mayto3May2013inthe openwindowfollowingtheannouncementofthefinancialresultsforthe firstquarterof2013. TheGrouphashadthefollowingmaterialtransactionswithrelatedparties, (income)/expense: ) ) ) DKKmillion 2015 2014 2013 Novo Nordisk Foundation Donations to StenoDiabetes Center A/S via NovoNordisk (69) (51) (45 Services provided by NovoNordisk (3) – – NovoA/S Services provided by NovoNordisk (3) (5) (4 Purchase of Novo Nordisk Bshares – – 2,504 Sale of NNIT A/S Bshares (797) – – NNITA/S 1 Services provided by NovoNordisk (32) – – Services provided by NNITA/S 1,316 – – Novozymes Services provided by NovoNordisk (185) (189) (214 Services provided byNovozymes 165 142 109 Xellia Pharmaceuticals Services provided by NovoNordisk (11) (28) – 1.Amountsstatedfor2015regardservicesprovidedduringtheentireyear.Beforethe partialdivestmentofNNITA/SinMarch2015NNITA/Swasconsolidatedasafully ownedsubsidiary. TherehavenotbeenanytransactionswiththeBoardof Directorsor ExecutiveManagementofNNITA/S,NovoNordiskA/S,NovozymesA/S,Novo A/S,theNovoNordiskFoundation,XelliaPharmaceuticalsApSorassociated companies.ForinformationonremunerationtotheManagementofNovo Nordisk,pleasereferto‘Remuneration’onpp49–51andnote2.4,‘Employee costs’.TherehavenotbeenandarenoloanstotheBoardofDirectorsor ExecutiveManagementin2015,2014or2013. Therearenomaterialunsettledtransactionswithrelatedpartiesattheend oftheyear.
NOVO NORDISK ANNUAL REPORT2015 CONSOLIDATED FINANCIAL STATEMENTS 93 5.6 COMPANIES IN THE NOVO NORDISKGROUP Activity: • Sales and marketing • Production • Research and development • Services/investments Company andcountry Percentage of sharesowned Activity Parentcompany Novo NordiskA/S,Denmark – • • •• Subsidiaries byregion Europe Novo Nordisk Pharma GmbH, Austria 100 • S.A. Novo Nordisk Pharma N.V., Belgium 100 • Novo Nordisk Pharma d.o.o., Bosnia-Hercegovina 100 • Novo Nordisk Pharma EAD, Bulgaria 100 • Novo Nordisk Hrvatska d.o.o., Croatia 100 • Novo Nordisk s.r.o., Czech Republic 100 • Novo Nordisk Pharmatech A/S, Denmark 100 •• Novo Nordisk Region Europe A/S, Denmark 100 • Steno Diabetes Center A/S, Denmark 100 •• Novo Nordisk Farma OY, Finland 100 • Novo Nordisk,France 100 • Novo Nordisk Production SAS, France 100 • Novo Nordisk Pharma GmbH, Germany 100 • Novo Nordisk Hellas Epe., Greece 100 • Novo Nordisk Hungária Kft., Hungary 100 • Novo Nordisk Limited, Ireland 100 • Novo Nordisk S.P.A.,Italy 100 • UAB Novo Nordisk Pharma, Lithuania 100 • Novo Nordisk Farma dooel, Macedonia 100 • Novo Nordisk B.V.,Netherlands 100 • Novo Nordisk Scandinavia AS, Norway 100 • • • • • • • • • • • • • • • • • • • • NovoNordiskPharmaceuticalServicesSp.z.o.o.,Poland 100 NovoNordiskComércio Produtos Farmace˜ uticosLda.,Portugal100 NovoNordiskFarmaS.R.L.,Romania 100 NovoNordiskPharmad.o.o.Belgrade(Serbia),Serbia 100 NovoNordiskSlovakias.r.o.,Slovakia 100 NovoNordisk,d.o.o.,Slovenia 100 NovoNordiskPharmaS.A.,Spain 100 NovoNordiskScandinaviaAB,Sweden 100 NovoNordiskHealthCareAG,Switzerland 100 NovoNordiskPharmaAG,Switzerland 100 NovoNordiskHoldingLimited,UnitedKingdom 100 NovoNordiskLimited,UnitedKingdom 100 NorthAmerica NovoNordiskCanadaInc.,Canada 100 NovoNordiskInvest3A/S,Denmark 100 NovoNordiskUSBioProduction,Inc.,UnitedStates 100 NovoNordiskUSHoldingsInc.,UnitedStates 100 NovoNordiskPharmaceuticalIndustriesInc.,UnitedStates 100 NovoNordiskInc.,UnitedStates 100 NovoNordiskResearchCenterIndianapolis,Inc.,UnitedStates 100 • Japan &Korea Novo Nordisk Region Japan & Korea A/S, Denmark 100 • NovoNordiskPharmaLtd.,Japan 100 •• Novo Nordisk Pharma Korea Ltd., SouthKorea 100 • Company andcountry Percentage of sharesowned Activity InternationalOperations AldaphSpA, Algeria 100 •• Novo Nordisk Pharma Argentina S.A.,Argentina 100 • Novo Nordisk Pharmaceuticals Pty. Ltd., Australia 100 • Novo Nordisk Pharma (Private) Limited,Bangladesh 100 • Novo Nordisk Produção Farmacêutica do Brasil Ltda.,Brazil 100 • Novo Nordisk Farmacêutica do Brasil Ltda.,Brazil 100 • Novo Nordisk Farmacêutica Limitada,Chile 100 • Novo Nordisk Colombia SAS,Colombia 100 • Novo Nordisk Pharma Operations A/S,Denmark 100 • Novo Nordisk Region International Operations A/S,Denmark 100 • Novo Nordisk Egypt LLC,Egypt 100 • Novo Nordisk India Private Limited,India 100 • Novo Nordisk Service Centre (India) Pvt. Ltd.,India 100 • PT. Novo Nordisk Indonesia,Indonesia 100 • Novo Nordisk Pars,Iran 100 • Novo Nordisk Ltd,Israel 100 • Novo Nordisk Pharma SARL,Lebanon 100 • Novo Nordisk Pharma (Malaysia) Sdn Bhd,Malaysia 100 • Novo Nordisk Pharma Operations (BASEA) Sdn Bhd,Malaysia 100 • Novo Nordisk Mexico S.A. de C.V.,Mexico 100 • Novo Nordisk Servicios Profesionales S.A. de C.V.,Mexico 100 • Novo Nordisk Farmacéutica S.A. de C.V.,Mexico 100 • Novo Nordisk Pharma SAS,Morocco 100 • Novo Nordisk Pharmaceuticals Ltd., New Zealand 100 • Novo Nordisk Pharma Limited,Nigeria 100 • Novo Nordisk Pharma (Private) Limited,Pakistan 100 • Novo Nordisk Pharmaceuticals (Philippines) Inc.,Philippines 100 • Novo Nordisk Limited Liability Company,Russia 100 • Novo Nordisk Production Support LLC,Russia 100 • Novo Investment Pte Limited,Singapore 100 • Novo Nordisk Pharma (Singapore) Pte Ltd.,Singapore 100 • Novo Nordisk (Pty) Limited, SouthAfrica 100 • Novo Nordisk Region International Operations AG, Switzerland 100 • Novo Nordisk Pharma (Thailand) Ltd.,Thailand 49 • Novo Nordisk Tunisie SARL, Tunisia 100 • Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti., Turkey 100 • Novo Nordisk Pharma Gulf FZ-LLC, United ArabEmirates 100 • Novo Nordisk Venezuela Casa de Representación C.A., Venezuela100 • •• • • • • • RegionChina NovoNordisk(China)PharmaceuticalsCo.,Ltd.,China 100 BeijingNovoNordiskPharmaceuticalsScience&TechnologyCo.,100 Ltd.,China NovoNordiskRegionChinaA/S,Denmark 100 NovoNordiskHongKongLimited,HongKong 100 NovoNordiskPharma(Taiwan)Ltd.,Taiwan 100 Othersubsidiariesandassociatedcompanies NNITA/S,Denmark 25.5 NNEPharmaplanA/S 1 ,Denmark 100 • 1. In addition to the companies listed above, NNE Pharmaplan A/S has its own subsidiaries.
NOVO NORDISK ANNUAL REPORT2015 94 CONSOLIDATED FINANCIALSTATEMENTS 5.7 FINANCIALDEFINITIONS ADR An American Depositary Receipt (or ADR) represents ownership in the shares of a non-US company and trades in US financial markets. Basic earnings per share(EPS) Net profit divided by the average number of sharesoutstanding. Diluted earnings pershare Net profit divided by average number of shares outstanding, including the dilutive effect of the outstanding restricted stock units. Effective tax rate Income taxes as a percentage of profit before incometaxes. Equity ratio Total equity at year-end as a percentage of total assets atyear-end. Grossmargin Gross profit as a percentage ofsales. Net profit margin Net profit as a percentage ofsales. Number of sharesoutstanding The total number of shares, excluding the holding of treasuryshares. Operating margin Operating profit as a percentage ofsales. Other comprehensive income(OCI) Othercomprehensive income comprisesallitemsrecognised inEquity forthe year other than those related totransactions with owners of the company. Examples ofitemsthat arerequiredtobepresented inOCIare: • Exchange rate adjustments of investments in subsidiaries • Remeasurements of defined benefit plans • Changes in fair value of financial instruments in a cash flow hedge. Payoutratio Total dividends for the year as a percentage of netprofit. Return onequity (ROE) Net profit for the year as a percentage of shareholders’ equity(average). Non-IFRSfinancial measures In the Annual Report, NovoNordiskdiscloses certain financial measures of the Group’s financial performance, financial position and cash flows that reflectadjustments tothemostdirectlycomparable measures calculated and presented in accordance with IFRS.These non-IFRS financial measures may notbedefined and calculated byothercompanies inthe same manner, and may thusnotbecomparable withsuchmeasures. The non-IFRS financial measures presented in the Annual Reportare: • Cash toearnings • Financial resources at the end of theyear • Free cashflow • Operating profit after tax to net operating assets • Underlying sales growth in localcurrencies. Cash toearnings Cashto earnings isdefined as‘freecash flow asapercentage ofnetprofit’. Financial resourcesattheendoftheyear Financial resourcesat the end of theyearisdefined as the sum of cash and cash equivalents attheend oftheyear,bonds with original termtomaturity exceeding threemonths and undrawn committed creditfacilities. Freecashflow NovoNordiskdefines free cash flow as ‘net cash generated from operating activities’ less‘net cash used in investing activities’ excluding ‘net change in marketable securities’. Net asset value pershare Defined as the company value per share, calculated by dividing the total net asset value of Novo Nordisk A/S by the number of sharesoutstanding. Operating profit after taxtonetoperating assets (OPAT/NOA) Operating profit after tax to net operating assets is defined as ‘operating profit after tax (using the effective tax rate) as a percentage of average inventories, receivables, property,plant and equipment, intangible assetsand deferred tax assets less non-interest-bearing liabilities including provisions and deferredtaxliabilities (whereaverage isthesum oftheabove assetsand liabilities atthebeginning oftheyearand atyear-enddivided bytwo)’. Underlying salesgrowth inlocal currencies Underlying sales growth in local currencies is defined as sales for the year measured at prior-yearaverage exchange rates compared with sales forthe prioryearmeasured atprior-yearaverage exchange rates.
NOVO NORDISK ANNUAL REPORT2015 Part of Management’sreview QUARTERLY FINANCIAL FIGURES 2014 AND 2015 95 QUARTERLY FINANCIAL FIGURES 2014 AND2015 DKKmillion Q1 2014 Q2 Q3 Q4 Q1 2015 Q2 Q3 Q4 Netsales 20,343 21,629 22,249 24,585 25,200 27,059 26,792 28,876 Sales by businesssegment: New-generationinsulin 80 141 175 262 271 330 376 461 Modern insulin (insulinanalogues) 9,377 10,351 10,641 11,168 11,498 12,604 12,500 13,562 Humaninsulin 2,573 2,475 2,478 2,772 2,897 2,784 2,772 2,778 Victoza ® 2,916 3,059 3,441 4,010 3,957 4,486 4,680 4,904 Other diabetes and obesitycare 1,013 1,031 953 1,064 1,195 1,075 1,223 1,237 Diabetes and obesity care total 15,959 17,057 17,688 19,276 19,818 21,279 21,551 22,942 Haemophilia 2,255 2,327 2,112 2,610 2,734 2,757 2,371 2,785 Norditropin ® 1,500 1,509 1,686 1,811 1,830 2,083 1,842 2,065 Otherbiopharmaceuticals 629 736 763 888 818 940 1,028 1,084 Biopharmaceuticalstotal 4,384 4,572 4,561 5,309 5,382 5,780 5,241 5,934 Sales by geographicalsegment: NorthAmerica 9,265 10,561 11,133 12,164 12,455 14,325 14,415 15,662 Europe 4,703 4,989 5,045 5,413 4,977 5,222 5,200 5,399 InternationalOperations 3,032 2,968 2,938 3,602 3,684 3,884 3,406 3,992 RegionChina 2,171 1,947 1,881 2,089 2,847 2,284 2,415 2,325 Japan &Korea 1,172 1,164 1,252 1,317 1,237 1,344 1,356 1,498 Grossprofit 16,877 17,958 18,823 20,586 21,326 23,200 22,945 24,268 Sales and distributioncosts 5,086 5,559 5,899 6,679 6,147 7,175 6,951 8,039 Research and developmentcosts 3,168 3,075 3,654 3,865 3,250 3,035 3,289 4,034 Hereof costs related to discontinuation of activities within inflammatorydisorders – – 600 – – – – – Administrativecosts 805 795 870 1,067 854 887 952 1,164 Other operating income,net 215 204 169 182 2,782 379 227 94 Non-recurring income from the partial divestment of NNIT A/S – – – – 2,376 – – – Operatingprofit 8,033 8,733 8,569 9,157 13,857 12,482 11,980 11,125 Netfinancials 268 256 (115) (805) (1,372) (1,934) (1,844) (811) Profit before income taxes 8,301 8,989 8,454 8,352 12,485 10,548 10,136 10,314 Incometaxes 1,843 1,995 1,954 1,823 2,609 2,205 1,753 2,056 Netprofit 6,458 6,994 6,500 6,529 9,876 8,343 8,383 8,258 Depreciation, amortisation and impairmentlosses 657 667 1,183 928 663 648 633 1,015 Totalassets 63,241 63,681 71,283 77,062 77,457 81,313 85,195 91,799 Total equity 33,583 36,661 37,967 40,294 32,108 39,111 43,109 46,969 FINANCIALRATIOS As percentage ofsales Sales and distributioncosts 25.0% 25.7% 26.5% 27.2% 24.4% 26.5% 25.9% 27.8% Research and developmentcosts 15.6% 14.2% 16.4% 15.7% 12.9% 11.2% 12.3% 14.0% Administrativecosts 4.0% 3.7% 3.9% 4.3% 3.4% 3.3% 3.6% 4.0% Grossmargin 1 83.0% 83.0% 84.6% 83.7% 84.6% 85.7% 85.6% 84.0% Operatingmargin 1 39.5% 40.4% 38.5% 37.2% 55.0% 46.1% 44.7% 38.5% Equityratio 1 53.1% 57.6% 53.3% 52.3% 41.5% 48.1% 50.6% 51.2% SHARERATIOS Basic earnings per share/ADR (inDKK) 1 2.44 2.66 2.49 2.51 3.80 3.24 3.27 3.25 Diluted earnings per share/ADR (inDKK) 2.43 2.66 2.47 2.51 3.79 3.23 3.26 3.24 Average number of shares outstanding (million) –basic 2,642 2,629 2,614 2,600 2,597 2,578 2,566 2,553 Average number of shares outstanding (million) –diluted 2,653 2,637 2,622 2,608 2,604 2,584 2,572 2,560 EMPLOYEES Number of full-time employees at the end of theperiod 39,579 40,226 40,700 40,957 39,062 39,658 40,261 40,638 1. For definitions, please refer to p94.
NOVO NORDISK ANNUAL REPORT2015 96 CONSOLIDATEDSOCIALSTATEMENT Supplementaryinformation STATEMENT OF SOCIALPERFORMANCE FOR THE YEAR ENDED 31DECEMBER Note 2015 2014 2013 PATIENTS Patients reached with Novo Nordisk diabetes care products (estimate in million) 2.1 26.8 24.4 24.3 Least developed countries where Novo Nordisk sells insulinaccording to the differential pricingpolicy 2.2 23 32 35 Donations (DKKmillion) 2.3 97 84 83 Animals purchased forresearch 2.4 67,240 64,533 72,662 New patent families (firstfilings) 2.5 77 93 77 EMPLOYEES Employees(total) 3.1 41,122 1 41,450 38,436 Employeeturnover 3.1 9.2% 9.0% 8.1% Working the Novo Nordisk Way (scale 1–5) 4.3 4.3 4.4 Gender in Management(men/women) 3.1 59%/41% 60%/40% 61%/39% Frequency of occupational accidents (number/million workinghours) 3.2 3.0 3.2 3.5 ASSURANCE Relevant employees trained in businessethics 98% 98% 97% Business ethicsreviews 49 42 45 Fulfilment of action points from facilitations of the Novo Nordisk Way 4.1 94% 95% 96% Supplieraudits 4.2 240 224 221 Productrecalls 4.3 2 2 6 Failedinspections 4.4 0 0 0 Company reputation (scale 0–100) 4.5 82.4 80.8 82.9 2 1.2015 data exclude employees in NNIT A/S, which was divested in2015. 2.Data for people with diabetes and employees are not included due to lack ofavailability.
NOVO NORDISK ANNUAL REPORT2015 Supplementary information CONSOLIDATED SOCIAL STATEMENT 97 Generalreportingstandardsandprinciples TheConsolidated socialstatement has been prepared inaccordance withthe Danish Financial Statements Act (FSA), sections 99a and 99b. Section 99a requires NovoNordiskto account for the company’s activities relating to social responsibility, reporting on business strategies, and activities in the areas of human rights, labour standards, environment, anti-corruption and climate.Section99brequiresNovoNordisktoaccount forthegender diversity atBoardlevelbyreporting ontargets and policiesensuring increased gender diversity over time. Companies that subscribe to the UNGlobal Compact and annually submit theirCommunication onProgresswill be incompliance with theFSA,provided that the annual reportincludes a reference towhere the information has been made publicly available . Read Novo Nordisk’s Communication on Progress 2015 at novonordisk.com/annualreport and on theUNGlobal Compact’swebsite at unglobalcompact.org/COP. Novo Nordisk adheres to the following internationally recognised voluntary reporting standards and principles (for overview, read more on p113): • UNGlobal Compact.Asa signatory totheUNGlobal Compact, a strategic policy initiative for businesses that are committed to aligning their operations and strategies with 10 universally accepted principles in the areas of human rights, labour, environment and anti-corruption, Novo Nordiskreportsonprogressduring 2015 initsCommunication onProgress, which can be found at novonordisk.com/annualreport. As a member of UNGlobal Compact LEAD,a platform fora selectgroup of companies to drive leadership to the next generation of sustainability performance, NovoNordiskdemonstrates itssustainability governance and management processes through the Blueprint for Corporate Sustainability Leadership, which isalsopartoftheCommunication onProgress. SECTION 1 BASIS OFPREPARATION • AA1000 framework foraccountability.Theframework (AA1000APS(2008) and AA1000AS(2008)) states that reporting must provide a complete, accurate, relevant and balanced picture of the organisation’s approach to and impact onsociety. ToNovoNordisk,AA1000APS(2008) isa component in creating a generally applicable approach to assessing and strengthening the credibility of the Group’s public reporting of social and environmental information . Novo Nordisk’sassurance processhas been designed toensure that the qualitative and quantitative information that documents the social and environmental dimensions of performance as well as the systems that underpin the data and performance are assured. Theprinciples outlined in AA1000APS(2008) have been applied asdescribedbelow. Inclusivity Asa pharmaceutical business with global reach, NovoNordiskiscommitted to being accountable to those stakeholders who are impacted by the organisation.NovoNordiskmaps itsstakeholders and has processesinplace to ensure inclusion of stakeholder concerns and expectations. In addition, Novo Nordisk continuously develops its stakeholder engagement and sustainability capacity atcorporateand affiliate levels. Materiality Key issues are identified through ongoing stakeholder engagement and trendspotting, and areaddressed by programmes oraction plans with clear and measurable targets. Long-term targets are set toguide performance in strategic areas.Theissuespresented intheannual reportaredeemed tohave a significant impact on the Group’s future business performance and may supportstakeholders intheirdecision-making. NOTES PATIENTS, EMPLOYEES ANDASSURANCE In the Consolidated social statement, Novo Nordisk reports on three dimensions of performance: patients, employees and assurance. Progress is reportedon two long-term targets: reach more patients with diabetes care productsand ensurethat theorganisation isworking theNovoNordiskWay. Tosupport the long-term targets the social statement contains additional performance information of strategic importance, such as least developed countriesbuying insulin according tothedifferential pricing policy,employee turnover,gender diversity,training of employees in business ethics, supplier audits and productquality. Access to qualitycare Novo Nordisk’s long-term target to reach 40 million people in 2020 with its diabetes care products is intended to enhance access to quality care. Thiscommitment ispursued through a focus on product innovation and a promise toalways provide affordable insulin. Thegraph on the right shows the expanded reach of NovoNordisk’sproducts: an estimated 26.8 million patients with diabetes worldwide, compared with 24.4 million in2014. This growth reflects increased sales of human insulin in low-and middle-income countriesand modern and new-generation insulins globally. Differentialpricingpolicy NovoNordisk sold human insulin according to the company’s differential pricing policy in 23 of the world’s48 poorest countries, compared with 32 countriesin2014.Thedecline isattributed tofewer insulin tendersin2015, and lackofresponsetotheoffer. 0 6 12 18 24 30 Million 2014 2015 PATIENTS REACHED WITH DIABETES CAREPRODUCTS 23 LDC COUNTRIES, DOWN FROM 32 IN2014 Basis ofpreparation AssurancePatients Employees
NOVO NORDISK ANNUAL REPORT2015 Supplementaryinformation98 CONSOLIDATEDSOCIALSTATEMENT Responsiveness Thereportreachesouttoawiderangeofstakeholders,eachwiththeir specificneedsandinterests.Tomoststakeholders,however,theannual reportisjustoneelementofinteractionandcommunicationwiththecom- pany.Theannualreportreflectshowthecompanyismanagingoperationsin waysthatrespondtoandconsiderstakeholderconcernsandinterests. Inaddition,NovoNordiskusesthecontentelementsandguidingprinciples oftheInternationalIntegratedReportingFramework,<IR>,developedbythe InternationalIntegratedReportingCounciltoguidethereporting. Applyingmateriality ItisNovoNordisk’sresponsibilitytoensurethatManagementprioritiesand thoseareasinwhichtheGrouphassignificantimpactareaddressed.Issues withrespecttosocialandenvironmentalreportingareprioritised,andthe issuesconsideredmostmaterialareincludedintheannualreport. Inassessingwhichinformationtoincludeintheannualreport,legalrequire- mentsanddisclosurecommitmentsmadebyNovoNordiskareconsidered. Furthermore,itisassessedwhetherinformationistieddirectlyorindirectlyto NovoNordisk’sabilitytocreatevalue.Short-andlong-termvaluecreationis takenintoconsideration. Theoutcomesofformalreviews,research,stakeholderengagementand internalmaterialitydiscussionsarepresentedasa proposalforannual reportingcontenttoExecutiveManagementandtheBoardofDirectors. The conclusion from the external assurance provider is available in the Independent assurance report on p111. Principlesofconsolidation TheConsolidatedsocialstatementanddisclosurescovertheNovoNordisk GroupcomprisingNovoNordiskA/SandentitiescontrolledbyNovoNordisk A/S. SOCIALACCOUNTINGPOLICIES Theaccountingpoliciessetoutbelowandinthenoteshavebeenapplied consistentlyinthepreparationoftheConsolidatedsocialstatementforall theyearspresentedwiththefollowingexceptions. Changes to accounting policies anddisclosures The following disclosure changes have been made to align with Management priorities: •‘Diverseseniormanagementteams’isreplacedby‘GenderinManagement (men/women)’toreflecttheupdatedpolicyfocusonallmanagerial levels.Externalreportingondiversityintermsofnationalityhasbeen discontinuedasitisnotlegalintheUStorecordemployees’nationality. EnsuringadiverseworkforceremainsafocusareaforNovoNordisk. •‘WarningLettersandre-inspections’isreplacedby‘Failedinspections’for consistencywithconformanceindicators. •‘Companyreputation’isreportedusinganewmethodologycoveringmore stakeholders. OTHERACCOUNTINGPOLICIES WorkingtheNovoNordiskWay WorkingtheNovoNordiskWayisanemployeeassessmentmeasuredona scaleof1–5,with5beingthebest,andisasimpleaverageofrespondents’ answerstoallmandatoryquestionsintheannualemployeesurvey,eVoice, coveringtheNovoNordiskWay.For2015,theeVoiceresponseratewas 91%,comparedwith94%in2014. Relevantemployeestrainedinbusiness ethics Themandatorybusinessethicstrainingisbasedongloballyapplicablee- learning,standardoperatingprocedures(SOPs)andrelatedtestsreleased annuallybytheNovoNordiskBusinessEthicsComplianceOffice.Thetarget groupsfortheindividualSOPsvaryinsizeandaredefinedbyNovoNordiskin eachSOP.ThetargetgroupsareallemployeesinNovoNordiskattheendof thereportingperiodexceptemployeesonleave,studentassistants,PhDsand postdocs.Thepercentageofemployeescompletingthetrainingiscalculated asthepercentageofcompletionofboththeSOPsandtherelatedtests, basedoninternalregistrations. Businessethicsreviews Thenumberof businessethicsreviewsisrecordedasthenumberof conductedbusinessethicsreviewsperformedbyGroupInternalAuditin affiliates,productionsitesandheadquarterareas.Furthermore,thenumber includesotherbusinessethicsassuranceactivitiessuchastrendreportsand third-partyreviews. SECTION 2PATIENTS 2.1 PATIENTS REACHED WITH NOVO NORDISK DIABETES CARE PRODUCTS (ESTIMATE) Accountingpolicies Thenumberoffull-yearpatientsreachedwithNovoNordiskdiabetescare products,exceptdevicesandPrandiMet ® ,isestimatedbydividingNovo Nordisk’sannualsalesvolumebytheannualusagedoseperpatientforeach productclassasdefinedbytheWHO.PrandiMet ® isnotincludedasno WHO-defineddosageexists. TheWHO-defineddailydosagehasnotchangedsince1982anditmaynot reflecttherecommendedorprescribeddailydoseprecisely.Actualdosesare basedonindividualcharacteristics(egageandweight)andpharmacokinetic considerations.Despitethisuncertainty,itisNovoNordisk’sassessmentthat thisisthemostconsistentwayofreporting. Development Theestimatednumberoffull-yearpatientsreachedwithNovoNordisk’s diabetescareproductsincreasedfrom24.4millionin2014to26.8millionin 2015.Thedevelopmentreflectsanoverallincreaseinthenumberofpeople treatedwithNovoNordisk’sinsulinproductsandwasmainlydrivenby humaninsulin(1.2millionpeople)andmodernandnew-generationinsulins (0.9millionpeople). 2.2 LEAST DEVELOPED COUNTRIES WHERE NOVO NORDISK SELLS INSULIN ACCORDING TO THE DIFFERENTIAL PRICINGPOLICY Accountingpolicies NovoNordiskhasformulateda differentialpricingpolicyfortheleast developedcountries(LDCs)asdefinedbytheUN.Thedifferentialpricing policyispartof NovoNordisk’sglobalinitiativetopromoteaccessto healthcareforallLDCs.Thepurposeofthepolicyistoofferhumaninsulinin vialstoallLDCsatorbelowamarketpriceof20%oftheaveragepricesfor humaninsulininvialsinthewesternworld.Thewesternworldisdefinedas Europe(theEU,SwitzerlandandNorway),theUS,CanadaandJapan.The numberofLDCswhereNovoNordisksellshumaninsulininvialsaccordingto thedifferentialpricingpolicyismeasuredbydirectorindirectsalesbyNovo Nordiskviagovernmenttenderor privatemarketsalesto wholesalers, distributorsornon-governmentalorganisations.
NOVO NORDISK ANNUAL REPORT2015 Supplementaryinformation 2.2 LEAST DEVELOPED COUNTRIES WHERE NOVO NORDISK SELLS INSULIN ACCORDING TO THE DIFFERENTIAL PRICING POLICY(CONTINUED) NUMBER OFLDCs 2015 2014 2013 TotalLDCs LDCs not buying according to pricingpolicy 48 3 48 2 49 3 LDCs with nosales 22 14 11 Total LDCs buying insulin according to pricingpolicy 23 32 35 NovoNordisksoldhumaninsulinaccordingtothecompany’sdifferential pricingpolicyin23oftheworld’s48poorestcountries,comparedwith32 countriesin2014.Thedeclineisattributedtofewerinsulintendersin2015, andlackofresponsetotheofferfromgovernmentsorprivatewholesalers andotherpartnerstoNovoNordisk’soffer.Thetotalnumberofpatients treatedwithinsulinsoldatorbelowthedifferentialpricingpolicypricewas approximately411,000in2015,whichisaslightdecreasecomparedwith approximately431,000in2014. In 2015, an estimated 5.5 million patients were treated with insulin for less than USD 0.19 per day, compared with 4.3 million patients in 2014. NovoNordiskoperatedinHaiti,KiribatiandMyanmar,butdidnotsellinsulin atthedifferentialpricehere.Thegovernmentsinthosecountrieswere offeredtheopportunitytobuyinsulinatthedifferentialprice,buttheinsulin soldtherein2015wassoldtotheprivatemarket. NovoNordiskisunabletoguaranteethatthepriceatwhichthecompany sellstheinsulinwillbereflectedinthefinalpricetotheconsumer.Printing thepriceontheactualproducthasbeenoneinitiativetriedtoavoidmark- upsonprice.WhileNovoNordiskpreferstosellinsulinatthedifferential pricethroughgovernmenttenders,thecompanyiswillingtoselltoprivate distributorsandagents. 2.3DONATIONS Accountingpolicies DonationsbyNovoNordisktotheWorldDiabetesFoundationandtheNovo NordiskHaemophiliaFoundationarerecognisedasanexpensewhenthe donationispaidoutorwhenanunconditionalcommitmenttodonatehas beenmade. For additionalinformationregardingthe World Diabetes Foundation,pleaserefertonote5.3intheConsolidatedfinancialstate- ments. DONATIONS IN DKKMILLION 2015 2014 2013 World DiabetesFoundation 78 66 64 Novo Nordisk HaemophiliaFoundation 19 18 19 Totaldonations 97 84 83 CONSOLIDATED SOCIAL STATEMENT 99 2.4ANIMALSPURCHASEDFORRESEARCH Accountingpolicies Animalspurchasedforresearchisrecordedasthenumberofanimals purchasedforallresearchundertakenbyNovoNordiskeitherin-houseorby externalcontractors.Thenumberofanimalspurchasedisbasedoninternal registrationof purchasedanimalsand yearlyreportsfrom external contractors. ANIMALSPURCHASED 2015 2014 2013 Mice, rats and otherrodents 65,335 62,423 69,883 Pigs 939 818 1,177 Rabbits 443 574 1,124 Dogs 214 374 238 Non-humanprimates 302 344 240 Othervertebrates 7 0 0 Total 67,240 64,533 72,662 Thenumberofanimalspurchasedforresearchin2015increasedby4% comparedwith2014duetoanincreaseinearly-phaseresearch.Inall,97% oftheanimalspurchasedwererodents,andthevariationinthepurchaseof largeanimalsfromyeartoyearreflectsthedifferentdevelopmentphasesthe researchprojectshavereached. 2.5 NEW PATENT FAMILIES (FIRSTFILINGS) Accountingpolicies New patent families (first filings) is recorded as the number of new patent applications that were filed during theyear. Development Atotalof77newpatentfamilieswereestablishedin2015,adecreaseof 17%comparedwithfilingactivityin2014,when93patentfamilieswere established.Thedecreasewasduetolowerpatent-filingactivityinGlobal Research. Thepatentexpirydatesfortheproductportfolioareshowninthetableon thenextpage.ThedatesprovidedareforexpiryintheUS,Germany,China andJapanofpatentsontheactiveingredient,unlessotherwiseindicated, andincludeextensionsofpatentterm(includingforpaediatricextension, whereapplicable).Forseveralproducts,inadditiontothecompoundpatent, NovoNordiskholdsotherpatentsonmanufacturingprocesses,formulations orusesthatmayberelevantforexclusivitybeyondtheexpirationofthe activeingredientpatent.Furthermore,regulatorydataprotectionmayapply.
NOVO NORDISK ANNUAL REPORT2015 SECTION 3 EMPLOYEES 100 CONSOLIDATED SOCIALSTATEMENT Supplementaryinformation 1.Formulation patent until2017. 2.Currentestimate. 3.Formulation patent providing exclusivity to the composition of excipients used in the drugproducts. 4.Room temperature-stable formulation patent until2023. 1.Process patents until 2028 in China, Germany and Japan and until 2030 in theUS. 2.Data protection runs until 2025. 3.Formulation patent expiring in2016. 4.Patent covers low-dose treatmentregimen. 5.Licensed to three generic manufacturers beginning in October2016. 2.5 NEW PATENT FAMILIES (FIRST FILINGS)(CONTINUED) MARKETED PRODUCTS IN KEY MARKETS(ACTIVEINGREDIENTS) US Germany China Japan Diabetescare: NovoRapid ® (NovoLog ® ) Expired 1 Expired 1 Expired 1 Expired 1 NovoMix ® 30 (NovoLog ® Mix70/30) Expired 1 Expired Expired Expired Levemir ® 2019 2019 Expired 2019 NovoNorm ® (Prandin ® ) Expired Expired Expired 2016 Victoza ® 2022 2022 2017 2022 Tresiba ® 2029 2 2028 2024 2027 Ryzodeg ® 2029 2 2028 2024 2027 Xultophy ® 2029 2 2028 2024 2027 Obesity: Saxenda ® 2022 2022 2017 2017 Biopharmaceuticals: Norditropin ® (Norditropin ® SimpleXx ® ) 2017 3 2017 3 2017 3 2017 3 NovoSeven ® Expired 4 Expired 4 Expired 4 Expired 4 NovoEight ® N/A 5 N/A 5 N/A 5 N/A 5 NovoThirteen ® (TRETTEN ® ) 2021 6 Expired 7 N/A 7 Expired 7 Vagifem ® 10mcg 2022 8,9 2021 8 N/A 2021 8 3.1EMPLOYEES Accountingpolicies Thenumberofemployeesisrecordedasallemployeesexceptexternals, employeesonunpaidleave,interns,bachelorandmasterthesisemployees, andsubstitutesatyear-end. Therateofturnoverismeasuredasthenumberofemployees,excluding temporaryemployees,wholefttheGroupduringthefinancialyearcompared withtheaveragenumberofemployees,excludingtemporaryemployees. DiversityinNovoNordiskisreportedasthepercentagesplitbygenderinall managerialpositionsand for newlyappointedmanagers. Managerial positionsaredefinedasallmanagersinNovoNordisk(globaljoblevelincl CEO, EVP,SVP,CVP,VP,Director,Managerand TeamLeader). New managersaredefinedasallemployeeswhohavemovedtoamanagerial positionwithinthelast12months–bothpromotedandexternallyhired. EMPLOYEES 2015 2014 2013 NorthAmerica Europe – of which in Denmark InternationalOperations Japan &Korea RegionChina 6,439 21,871 17,398 7,304 1,119 4,389 6,465 6,16 2 22,136 20,28 6 17,664 16,027 6,666 6,05 4 1,086 1,08 4 5,097 4,85 0 Totalemployees 41,122 41,450 38,436 Employees(FTEs) 40,638 40,957 37,978 Employeeturnover 9.2% 9.0% 8.1% Increase inemployees (1%) 8% 11% Gender inManagement (men/women) 59%/41% 60%/40% 61%/39% Share of women among newly appointedmanagers 44% 42% 41% Theslightdecreaseinthetotalheadcountisduetothedivestmentof NNIT A/Sin2015.Theunderlyinggrowth(5%)isinlinewithexpectationsandis primarilydrivenby expansionwithin the salesregionInternational Operationsandintheresearch&developmentandproductionorganisa- tions,primarilyinDenmark.Employeeturnoverincreasedslightly,primarily drivenbyRegionChina. Among employees as a whole, the gender split was 50/50 in 2015, which is the same as in2014. 3.2 FREQUENCY OF OCCUPATIONAL ACCIDENTS Accountingpolicies Thefrequencyofoccupationalaccidentswithabsenceismeasuredasthe internallyreportednumberofaccidentsforallemployees(FTEs),excluding externals,employeesonunpaidleave,interns,bachelorandmasterthesis employees,and substitutes,per millionnominalworkinghours. An occupationalaccidentwithabsenceisanywork-relatedaccidentcausingat leastonedayofabsenceinadditiontothedayoftheaccident. Development In2015,asalesrepresentativeinIndiadiedinatrafficaccidentwhileon duty.Priortothistragicaccident,NovoNordiskhadnothadanyfatal occupationalaccidentssince2011.Thenumberofoccupationalaccidents withabsencedecreasedby7% comparedwith2014.Thefrequencyof occupationalaccidentsdecreasedfrom3.2permillionworkinghoursin 2014to3.0permillionworkinghoursin2015.NovoNordiskisworking withazero-injurymindsetandthelong-termcommitmentistocontinuously improveperformance. Focusis on strengtheningriskawarenessand preventingoccupationalaccidentsforallemployees.
NOVO NORDISK ANNUAL REPORT2015 Supplementaryinformation CONSOLIDATED SOCIAL STATEMENT 101 SECTION 4ASSURANCE 4.1FULFILMENTOFACTIONPOINTS FROMFACILITATIONSOFTHENOVO NORDISKWAY Accountingpolicies Facilitationistheinternalauditprocessforassessingcompliancewiththe NovoNordiskWay.Theassessmentisbasedonreviewofdocumentation followedbyan on-sitevisitwhererandomlyselectedemployeesand Managementareinterviewed.AnygapsbetweentheNovoNordiskWay andperformanceoftheprocessesareidentifiedandpresentedtoManage- mentasfindings.ThefacilitatorandManagementagreeonanactionplanto closethefindings.Thepercentageoffulfilmentofactionpointsarisingfrom facilitationsoftheNovoNordiskWayismeasuredasanaverageoftimely closureofactionpointsissuedinthecurrentyearandthetwo previous years. Thereasonforusinga three-yearaverageasthebasisforthe calculationisthatactionleadtimestypicallyvaryfromacoupleofmonthsto morethanayear. FACILITATIONS ANDFINDINGS 2015 2014 2013 Fulfilment of action points from facilitations of the Novo NordiskWay 94% 95% 96% Facilitations 65 69 75 Findings 257 213 178 Atotalof65unitswerefacilitatedcoveringapproximately18,500employees, 15%ofwhomwereinterviewed.Overall,thefacilitationsin2015show a ’highlevel’ofcompliancewiththeNovoNordiskWay.Correctiveactions andcorrespondingdeadlineshavebeenagreedwithlocalmanagementfor allfindings.Themainareasofimprovementidentified,covering60%ofthe findings,concernedEssential2(’Wesetambitiousgoalsandstrive for excellence’),Essential7 (’We focus on personalperformanceand development’)andEssential9(’Weoptimisethewayweworkandstrivefor simplicity’). TheEssentials,of whichthereare10, arethe basisfor implementationoftheNovoNordiskWay. 4.2SUPPLIERAUDITS Accountingpolicies ThenumberofsupplierauditsconcludedbyNovoNordisk’sSupplierAudit departmentincludesthenumberofresponsiblesourcingauditsandquality auditsconductedintheareasofdirectandindirectspendonmaterials. BY TYPE OFAUDIT 2015 2014 2013 Responsible sourcing audits 28 25 25 Qualityaudits 212 199 196 Total supplieraudits 240 224 221 Thelevelofauditsconcludedin2015increasedby7% comparedwith2014, whichwasmainlyduetoManagement’sdecisiontobuildnewfactories. Onecriticalfindingwasissuedinconnectionwithaqualityauditin2015.A continuousimprovementandengagementprogrammehasbeeninitiated withthesupplierinordertoaddresstheissue. 4.3PRODUCTRECALLS Accountingpolicies ThenumberofproductrecallsisrecordedasthenumberoftimesNovo Nordiskhasinstitutedarecallandincludesrecallsinconnectionwithclinical trials.Arecallcanaffectvariouscountriesbutonlycountsasonerecall. Development In2015,NovoNordiskhadtwoinstancesofproductrecalls,whichisatthe samelevelasin2014.Bothrecallswererelatedtoincorrectlabellingof products.Localhealthauthoritieswereinformedinbothinstancestoensure thatdistributors,pharmacies,doctorsandpatientsreceivedappropriate information. 4.4FAILEDINSPECTIONS Accountingpolicies ThenumberoffailedinspectionsismeasuredinrelationtotheUSFood& DrugAdministration,EuropeanMedicinesAgency(EMA), theJapanese Pharmaceuticals&MedicalDevicesAgency(PMDA),Lloyd’sRegisterQuality Assurance(LRQA)anddomesticauthoritiesforstrategicmanufacturingsites. FailedinspectionsaredefinedasinspectionswhereWarningLettersorEMA non-compliancelettersrelatedtoGMPinspectionsarereceived,GMP/ISO certificatesforstrategicsitesarelost,pre-approvalinspectionsresultina WarningLetter,studyconclusionsarechangedduetoGCP/GLPinspection issues,ormarketingorimportauthorisationsarewithdrawnduetoinspection issues.StrategicsitesaredefinedasthemanufacturingsitesinBrazil,China, Denmark,FranceandtheUS. Development In2015,asin2014,therewerenofailedinspectionsamongthoseresolved atyear-end.Atotalof82inspectionswereconducted,andatyear-end57 werepassedand25wereunresolvedasfinalinspectionreportshadnotbeen receivedatyear-endorthefinalauthorityacceptancewaspending,whichis normal. 4.5COMPANYREPUTATION Accountingpolicies CompanyreputationismeasuredannuallyusingtheRepTrak ® methodology developedbyReputationInstitute.Thetotalscoreismeasuredasthemean company reputationscore among people with diabetes, general practitioners,diabetesspecialistsandemployeesacross15keymarkets. Reputationismeasuredonascaleof0–100,with100beingthebest possiblescore.Ascoreabove80isconsideredexcellent. Thedataforexternalstakeholdersarecollectedthroughannualsurveys carriedoutbyexternalconsultancyfirms.Theemployeedataarecollected fromtheyearlyemployeesurvey.Forafewofthemarkets,historicaldata arenotavailableforalltheexternalstakeholdergroupsincluded.Thishas beenassessedashavingnomaterialimpactonthenumbersreportedand developmenttrends. COMPANYREPUTATION BY STAKEHOLDERGROUP 2015 2014 2013 People withdiabetes 73.9 71.9 N/A Employees 83.8 84.0 N/A Generalpractitioners 85.4 82.2 81.9 Diabetesspecialists 86.4 85.1 83.9 Totalscore 82.4 80.8 82.9
NOVO NORDISK ANNUAL REPORT2015 IntheConsolidatedenvironmentalstatement,NovoNordiskreportson performanceintermsofinputsofresourcesandoutputswithfiguresfor emissions,organicresiduesandwaste.Progressisreportedagainstthelong- termtargetstocontinuouslyreduceenvironmentalimpacts. Tosupportthetwolong-termtargets,theenvironmentalstatementcontains additionalperformanceinformationofstrategicimportancesuchasorganic residue,wasteandbreachesofregulatorylimitvalues. Challenges inmeeting targetson waterandenergy Energyconsumptionincreasedby9% andwaterconsumptionby6% comparedwithlastyear,whilesales,measuredinlocalcurrencies,increased by8%. Thisdevelopmentinperformanceisprimarilyduetoincreased productiontomeetmarketdemandsandfurthermore,anewinsulin-filling plantinRussiabecamefullyoperationalin2015. Significant reductioninCO 2 emissions In2015NovoNordisksignificantlyreducedCO 2 emissionsfromproduction andproductdistributionbyatotalof27,000tonsdespitetheincreasein sales.CO 2 emissionsfromenergyconsumptiondecreasedby11%duetoan increasedshareofrenewableenergy,whichisastrategicpriorityfor Novo Nordisk. At theproductionsiteinTianjin,China,NovoNordiskstarted sourcing‘GoldPower’renewableenergycertificates,andinDenmark31% ofthenaturalgaswasreplacedbybio-naturalgas,whichisbiogasupgraded tothequalityofnaturalgasanddistributedviathenaturalgassystem.Itis theambitionthatallproductionsitesarerunonrenewablepowerby2020. Supplementaryinformation102 CONSOLIDATED SOCIALSTATEMENT STATEMENT OF ENVIRONMENTAL PERFORMANCE FOR THE YEAR ENDED 31DECEMBER NOTES RESOURCES, EMISSIONS, ORGANIC RESIDUES ANDWASTE Note 2015 2014 2013 RESOURCES Energy consumption (1,000GJ) 2.1 2,778 2,556 2,572 Water consumption (1,000m 3 ) 2.2 3,131 2,959 2,685 EMISSIONS, ORGANIC RESIDUES ANDWASTE CO 2 emissions from energy consumption (1,000 tons) 3.1 107 120 125 CO 2 emissions from transport (1,000tons) 3.1 43 57 59 Organic residues(tons) 3.2 124,049 110,095 110,228 Waste(tons) 3.3 34,715 30,720 20,387 Non-hazardous waste(ratio) 3.3 42% 50% 63% Breaches of regulatory limitvalues 3.4 28 9 14 Basis ofpreparation Emissions, organic residues and wasteResources DEVELOPMENT IN ENERGY AND WATER CONSUMPTION VERSUSSALES Energy Water Sales in localcurrencies % 15 12 9 6 3 0 2014 2015 3 0 6 9 12 15 2014 2015 % DEVELOPMENT IN ENERGY AND WATER CONSUMPTION VERSUSSALES Q Energy Q Water Q Sales in localcurrencies 27,000 OF CO 2 EMISSIONS TONS REDUCTION 2 TONS REDUCTION OF CO EMISSIONS 27,000
NOVO NORDISK ANNUAL REPORT2015 Supplementaryinformation CONSOLIDATED ENVIRONMENTAL STATEMENT 103 Generalreportingstandardsandprinciples TheConsolidatedenvironmentalstatementhasbeenpreparedinaccordance withthesamestandardsasthosefortheConsolidatedsocialstatement. Readmoreinsection1‘Basisofpreparation’oftheConsolidatedsocial statementonp97. Principlesofconsolidation TheConsolidatedenvironmentalstatementcoverstheproductionsites includingofficebuildings,exceptforCO 2 emissionsfromtransport,which includesexternalforwardersusedtodistributeNovoNordiskproducts. ENVIRONMENTALACCOUNTINGPOLICIES Theaccountingpoliciessetoutbelowhavebeenconsistentlyappliedin preparationoftheConsolidatedenvironmentalstatementforalltheyears presented. Changes to accounting policies anddisclosures The following disclosure change has been made to align with Management priorities: •‘CO 2 emissions from refrigerants’ has been omitted as it is not used as Managementinformation. SECTION 1 BASIS OFPREPARATION SECTION 2RESOURCES SECTION 3 EMISSIONS, ORGANIC RESIDUES ANDWASTE 3.1CO 2 EMISSIONS Accountingpolicies CO 2 emissionsfromenergyconsumption TheamountofCO 2 emissionsfromenergyconsumptioncoversconsumption relatedtoproductionmeasuredinmetrictons.CO 2 emissionsfromenergy consumptioniscalculatedaccordingtotheGreenhouseGas(GHG)Protocol andbasedonemissionfactorsfromthepreviousyear. CO 2 emissionsfromtransport(productdistribution) CO 2 emissionsfromproductdistributioniscalculatedbyexternaltrans- portationsuppliersastheestimatedemissionsfromproductdistributionin metrictons.Itiscalculatedastheworldwidedistributionofsemi-finished andfinishedproducts,rawmaterialsandcomponentsbyair,seaandroad betweenproductionsitesandfromproductionsitestoaffiliates, directcustomersandimportingdistributors.CO 2 emissionsfromproduct distributionfromaffiliatestopharmacies,hospitalsandwholesalersarenot included. 2.1ENERGYCONSUMPTION Accountingpolicies Energyconsumptionismeasuredasbothdirectsupplyofenergy(internally producedenergy),whichisenergyNovoNordiskproducesfrommainly naturalgasandwood,andindirectsupplyofexternalenergy(externally producedenergy),whichiselectricity,steamanddistrictheat.Theconsump- based on meter readings andinvoices. Totalenergyconsumption 2,778 2,556 2,572 1.Notallocatedconsistsofconsumptionthatcannotbedirectlylinkedtotheproduction ofeitherDiabetesandobesitycareorBiopharmaceuticals,ieofficebuildingsand researchactivities. In2015,energyconsumptionincreasedby9% comparedwith2014dueto increasedproductionvolumeandincreasedproductioncapacity,asthesite inRussiaisnowfullyoperationalandhenceincludedinthecorporate reportingforthefirsttime. 2.2 WATERCONSUMPTION Accountingpolicies Water consumption is measured based on meter readings and invoices. It includes drinking water, industrial water andsteam. WATERCONSUMPTION tion of fuel (internally produced energy) and externally produced energyis IN 1,000M 3 2015 2014 2013 Diabetes and obesitycare 2,753 2,568 2,261 ENERGYCONSUMPTION Biopharmaceuticals 213 209 244 IN1,000 GJ 2015 2014 2013 Notallocated 1 165 182 180 Diabetes and obesitycare 2,006 1,816 1,762 Total waterconsumption 3,131 2,959 2,685 Biopharmaceuticals 322 316 362 Notallocated 1 450 424 448 1. Not allocated consists of consumption that cannot be directly linked to theproduction of either Diabetes and obesity care or Biopharmaceuticals, ie office buildings and research activities. In2015,waterconsumptionincreasedby6% comparedwith2014dueto increasedproductionin allbusinessareasto meetmarketdemands. Optimisationsof waterpurificationatthefillingplantinClayton,US, reducedwaterconsumptionatthissiteby27%.75%ofthewaterisused inDenmark.In2015,14%ofthewaterwasusedatlocationsclassifiedas water-scarcecomparedwithlastyearwhen70%ofthewaterusedwasat locationsclassifiedaswater-scarce.Sincethen,KalundborginDenmarkhas beenreclassifiedandisnolongerconsideredawater-scarcearea.
NOVO NORDISK ANNUAL REPORT2015 CO 2 EMISSIONS IN 1,000TONS 2015 2014 2013 priorityofincreasingtheshareofrenewableenergy.In2015,thefillingplant inTianjin,China,startedtosourcerenewableenergycertificatesfroma windfarm,andaboutone-thirdofthenaturalgasinDenmarkwasreplaced bybio-naturalgas.Thisisbiogasupgradedtothequalityofnaturalgas. CO 2 emissionsfromtransport(productdistribution)decreasedsignificantly, by25%, comparedwith2014.Thisismainlyduetoanincreaseinthe volumeofproductsbeingdistributedviaseafrom72%in2014to83%in 2015.In2015,CO 2 emissionsfromseafreightaccountedfor16%,transport viatrucks5% andairtransport79%oftotalemissions.Distributingasmany productsaspossiblebyseaisapriorityforNovoNordisk,asitreducesboth CO 2 emissionsandcosts. 3.2ORGANICRESIDUES Accountingpolicies Organicresiduesconsistof recycledbiomassand ethanolfromthe productionoftheactiveingredients.Thebiomassismeasuredinm 3 and convertedtotons.Theamountofethanoliscalculatedbasedonvolumeand concentrationandthenconvertedtotons.Theresiduesareprimarilyusedin biogasplantswhereenergyisrecovered.Thebiomassisusedasfertilizerson localfarmlandafterthebiogasproduction. ORGANIC RESIDUES(TONS) 2015 2014 2013 Biomass 113,453 101,729 104,324 Ethanol 10,596 8,366 5,904 Total organicresidues 124,049 110,095 110,228 Biomassincreasedby12%andrecycledethanolby27%in2015compared with2014duetoincreasedproductionactivitiesintheDiabetesandobesity carebusiness.Therelativelyhighincreaseinrecyclableethanolisduetoless internalre-usefollowingstart-upofnewproductionlinesandchallenges withimpurities. 104 CONSOLIDATED ENVIRONMENTALSTATEMENT 3.1 CO 2 EMISSIONS(CONTINUED) Supplementaryinformation 3.3WASTE Accountingpolicies –Diabetes and obesitycare 88 94 96 Waste is measured as the sum of non-hazardous and hazardouswaste disposed of based on weightreceipts. –Biopharmaceuticals 6 10 11 –Notallocated 1 13 16 18 Non-hazardous waste (ratio) is calculated as a percentage of thetotal CO 2 emissions from energyconsumption 107 120 125 amount of waste disposedof. CO 2 emissions fromtransport 43 57 59 Total CO 2 emissions 150 177 184 1.Notallocatedconsistsofconsumptionthatcannotbedirectlylinkedtotheproduction ofeitherDiabetesandobesitycareorBiopharmaceuticals,ieofficebuildingsand researchactivities. CO 2 emissions from energy consumption decreased by 11% in 2015 despite increased energy consumption. The decrease is a result of thecontinued TONS OFWASTE 2015 2014 2013 Non-hazardouswaste Hazardouswaste 14,500 20,215 15,492 12,81 3 15,228 7,57 4 Totalwaste 34,715 30,720 20,387 Non-hazardous waste (ratio) 42% 50% 63% 2013 2014 2015 100 80 60 40 20 0 WASTE Q Recycling Q Incineration with energyrecovery Q Incineration without energy recovery Q Special treatment Q Land?lling % Wasteincreasedby13% from2014to2015,primarilyduetoincreased productionofdiabetesandobesitycareproducts,whichledtoa33% increaseintheamountofhazardouswasteofwhichthemajoritywasnon- recyclableethanol.Thisethanolisdisposedofinspecialincinerationplants withenergyrecovery.Non-hazardouswastedecreasedby6% which was mainlyduetore-classificationofureafromwastetofertilizer. 3.4 BREACHES OF REGULATORY LIMIT VALUES Accountingpolicies Breaches of regulatory limit values covers all breaches reported to the environmentalauthorities. Development Breachesofregulatorylimitvaluesincreasedfrom9in2014to28in2015. Allbreacheshavebeenreportedtotheauthorities.24breachesarerelated towastewaterwithonlyminorimpactontheenvironment. Thelarge increaseisduetoachangeofcleaningagentatonefillingplant.Thischange wasarequirementfromthelocalauthoritiesandcorrectiveactionsare beingtaken.
NOVO NORDISK ANNUAL REPORT2015 INCOMESTATEMENT FOR THE YEAR ENDED 31DECEMBER BALANCESHEET AT 31DECEMBER FINANCIAL STATEMENTS OF THE PARENT COMPANY 105 FINANCIAL STATEMENTS OF THE PARENT COMPANY2015 The following pages comprise the financial statements of the parent company, being the legal entity NovoNordiskA/S.Apart from ownership of thesubsidiaries intheNovo Nordisk Group,theactivitywithin the parent company mainly comprises sales, research and development, production, corporate activities and support functions. ) DKKmillion Note 2015 2014 Sales Cost of goodssold 2 3 65,911 11,974 55,739 12,260 Grossprofit 53,937 43,479 Sales and distributioncosts 3 14,528 10,715 Research and development costs 3 11,265 11,737 Administrative costs 3 1,686 1,627 Other operating income, net 3,644 932 Non-recurring income from the partial divestment of NNITA/S 10 1,732 – Operatingprofit 30,102 20,332 Profit in subsidiaries, net oftax 11 14,800 10,963 Financial income 4 554 160 Financial expenses 4 6,099 788 Profit before incometaxes 39,357 30,667 Incometaxes 5 4,734 4,254 Net profit for theyear 34,623 26,413 Proposed appropriation of netprofit: Dividends 16,230 12,905 Net revaluation reserve according to the equity method (3,050) (1,856 Retained earnings 21,443 15,364 34,623 26,413 DKKmillion Note 2015 2014 ASSETS Intangible assets 7 1,918 1,124 Property, plant and equipment 8 17,797 15,686 Financial assets 10,11 16,057 18,939 Total non-currentassets 35,772 35,749 Rawmaterials 1,541 1,327 Work inprogress 6,503 5,828 Finishedgoods 1,524 1,254 Inventories 9,568 8,409 Tradereceivables 1,729 1,950 Amounts owed by affiliated companies 10,752 10,272 Taxreceivables 3,708 3,053 Other receivables 624 780 Receivables 16,813 16,055 Deferred income taxassets 6 1,668 1,484 Marketable securities 3,539 1,505 Derivative financial instruments 304 30 Cash at bank and onhand 15,493 13,268 Total currentassets 47,385 40,751 Totalassets 83,157 76,500 EQUITY ANDLIABILITIES Sharecapital Net revaluation reserve according to the equity method Retained earnings 520 4,977 40,861 530 8,696 31,068 Totalequity 9 46,358 40,294 Deferred income taxliabilities 6 15 – Otherprovisions 12 717 565 Totalprovisions 732 565 Currentdebt 778 462 Derivative financial instruments 1,382 2,607 Tradepayables 2,288 2,231 Amounts owed to affiliated companies 26,380 25,404 Taxpayable 188 186 Otherliabilities 12 5,051 4,751 Currentliabilities 36,067 35,641 Totalliabilities 36,067 35,641 Total equity andliabilities 83,157 76,500
NOVO NORDISK ANNUAL REPORT2015 ForinformationregardingremunerationtotheBoardofDirectorsand ExecutiveManagement,pleasereferto‘Remuneration’onpp49–51and note2.4totheConsolidatedfinancialstatements. FINANCIALEXPENSES DKKmillion 2015 2014 Interest income relating tosubsidiaries 88 64 Income from associatedcompany 47 – Other financialincome 419 96 Total financialincome 554 160 Interest expenses relating tosubsidiaries 16 18 Foreign exchange loss(net) 648 540 Other financialexpenses 5,435 230 Total financialexpenses 6,099 788 5 INCOMETAXES Uncertain tax positions are presented individually as part of Tax receivables/ Taxpayables. Novo Nordisk A/S and its Danish subsidiaries’ tax contribution to the joint taxation in 2015 amounts to DKK 4,958 million (DKK 5,082 million in2014). to the various balance sheet items asfollows: TheDanishcorporatetaxratewas23.5%in2015(24.5%in2014).Deferred taxhasbeencalculatedbasedonexpectedrealisation,reflectingthe reductionintheDanishcorporatetaxrate(downto22%in2016).Theeffect ofthechange,DKK102million(DKK119millionin2014),isincludedintotal deferredincometax. 106 FINANCIALSTATEMENTSOFTHEPARENTCOMPANY NOTES 1ACCOUNTINGPOLICIES Thefinancialstatementsoftheparentcompanyhavebeenpreparedin accordancewiththeDanishFinancialStatementsAct(ClassD)andother accountingregulationsforcompanieslistedonNASDAQCopenhagen. 3 EMPLOYEECOSTS DKKmillion 2015 2014 Wages andsalaries 10,012 9,080 Share-based paymentcosts 246 172 Pensions 902 829 Other social securitycontributions 216 219 Otheremployeecosts 335 313 Total employeecosts 11,711 10,613 Change in employee costs included ininventories 145 157 Theaccountingpoliciesforthefinancialstatementsoftheparentcompany areunchangedfromthelastfinancialyear,withtheexceptionofthe accountingpolicy regardingassociatedcompanies. The accounting policiesarethesameasfortheConsolidatedfinancialstatementswiththe adjustmentsdescribedbelow.Foradescriptionoftheaccountingpoliciesof theGroup,pleaserefertotheConsolidatedfinancialstatements,pp61–62. No separate statement of cash flows has been prepared for the parent company; please refer to the Statement of cash flows for the Group on p58. 2015 2014 SUPPLEMENTARY ACCOUNTING POLICIESFOR Average number offull-time THE PARENTCOMPANY employees in Novo NordiskA/S 15,437 14,821 Financialassets In the financial statements of the parent company, investments insubsidiaries are recorded under the equity method, using the respective share of the net 4 FINANCIAL INCOMEAND asset values in subsidiaries. Net profit of subsidiaries less unrealised intra- Group profits is recorded in the Income statement of the parent company. Totheextentnetprofitexceedsdeclareddividendsfromsuchcompanies, netrevaluationofinvestmentsinsubsidiariesistransferredtoNetrevaluation reserveunderEquityaccordingtotheequitymethod.Profitsinsubsidiaries aredisclosedasprofitaftertax. Fairvalueadjustmentsoffinancialassetscategorisedas‘Availableforsale’ arerecognisedintheIncomestatement. Fortheaccountingpolicyregardinginvestmentsinassociatedcompanies pleaserefertonote10. Tax ForDanishtaxpurposes,theparentcompanyisassessedjointlywithits Danishsubsidiaries.TheDanishjointlytaxedcompaniesareincludedina Danishon-accounttaxpaymentschemeforDanishcorporateincometax. Allcurrenttaxesundertheschemearerecordedintheindividualcompanies. NovoNordiskA/SanditsDanishsubsidiariesareincludedinthejointtaxation oftheparentcompany,NovoA/S. 2SALES DKKmillion 2015 2014 Sales by business segment Diabetes and obesity care Biopharmaceuticals 65,665 246 55,47 6 26 3 Totalsales 65,911 55,739 Sales by geographical segment NorthAmerica 33,491 23,961 Europe 13,861 13,764 InternationalOperations 9,825 8,985 Japan &Korea 2,418 2,472 RegionChina 6,316 6,557 Totalsales 65,911 55,739 In 2015, Novo Nordisk A/S paid income taxesofDKK 5,883 millionrelatedto thecurrentyear(DKK5,520millionin2014) a intaxesregardingprioryears(DKK603mill incometaxesofDKK23millionhavebeenpai subsidiaries(DKK19millionin2014). nd received DKK 437million ion in 2014). Furthermore, d in income taxes by Danish 6 DEFERRED INCOMETAX ASSETS/(LIABILITIES) DKKmillion The deferred tax assets/liabilities areallocated 2015 2014 Property, plant and equipment (646) (690) Indirect productioncosts (1,057) (1,007) Unrealised internalprofit 3,197 2,760 Sales are attributed to geographical segment based on location of the Other 159 421 customer. For definitions of segments, please refer to note 2.2 tothe Consolidated financialstatements. Total income taxassets/(liabilities) 1,653 1,484
NOVO NORDISK ANNUAL REPORT2015 FINANCIAL STATEMENTS OF THE PARENT COMPANY 107 7 INTANGIBLEASSETS ) ) DKKmillion 2015 2014 Cost at the beginning of the year Additions during the year Disposals during theyear 2,205 1,158 – 2,351 317 (463 Cost at the end of theyear 3,363 2,205 Amortisation at the beginning of theyear 1,081 1,052 Amortisation during theyear 121 98 Impairment losses for theyear 243 394 Amortisation and impairment losses reversed on disposals during theyear – (463 Amortisation at the end of theyear 1,445 1,081 Carryingamountattheendoftheyear 1,918 1,124 Intangible assets primarily relate to patents and licences, internally developed software, and costs related to major IT projects. 8 PROPERTY, PLANT AND EQUIPMENT Payments onaccount andassets ) ) DKKmillion Landand buildings Plantand machinery Other equipment in courseof construction 2015 2014 Cost at the beginning of theyear 12,351 16,093 2,215 3,912 34,571 32,664 Additions during theyear 189 172 115 3,380 3,856 2,547 Disposals during theyear (62) (258) (152) – (472) (640 Transfer from/(to) otheritems 327 631 125 (1,083) – – Cost at the end of theyear 12,805 16,638 2,303 6,209 37,955 34,571 Depreciation and impairment losses at the beginning of theyear 5,235 12,119 1,531 18,885 17,443 Depreciation for theyear 524 951 178 1,653 1,847 Impairment losses for theyear – 34 14 48 84 Depreciation reversed on disposals during theyear (44) (233) (151) (428) (489 Depreciation and impairment losses at the end of theyear 5,715 12,871 1,572 – 20,158 18,885 Carryingamountattheendoftheyear 7,090 3,767 731 6,209 17,797 15,686 9 STATEMENT OF CHANGES INEQUITY Net Share revaluation Retained DKKmillion capital reserve earnings 2015 2014 Balance at the beginning of theyear 530 8,696 31,068 40,294 42,569 Appropriated from Net profit for theyear 21,443 21,443 15,364 Proposeddividends 16,230 16,230 12,905 Appropriated from Net profit for the year to Net revaluationreserve (3,050) (3,050) (1,856) Effect of hedged forecast transactions transferred to the Incomestatement 2,162 2,162 (1,201) Fair value adjustments of cash flow hedges for theyear (614) (614) (2,162) Dividendspaid (12,905) (12,905) (11,866) Share-based payments (note3) 246 246 172 Tax credit related to share optionscheme 9 9 54 Purchase of treasuryshares (17,229) (17,229) (14,728) Sale of treasuryshares 33 33 61 Reduction of the B sharecapital (10) 10 – – Exchange rate adjustments of investments insubsidiaries (669) – (669) (35) Otheradjustments 408 408 1,017 Balanceattheendoftheyear 520 4,977 40,861 46,358 40,294 Pleaserefertonote4.1totheConsolidatedfinancialstatementsregardingaveragenumberofshares,treasurysharesandtotalnumberofAandBsharesin NovoNordiskA/S. 10INVESTMENTINASSOCIATEDCOMPANY Ondivestmentof74.5%ofthesharesinNNITA/Son6March2015,theremaininginterestbecameanassociatedcompanyofNovoNordiskA/S.Netgainonthe divestmentisdeterminedasthedifferencebetweenthesalesproceedsandthecarryingamountofnetassets.Theremaininginterestismeasuredatthecarrying amountofnetassetsatthedatewhencontrolislostwithnorevaluationtofairvalue.TheinvestmentisadjustedbyNovoNordisk’sshareofresultsaftertaxof theassociatedcompany.
NOVO NORDISK ANNUAL REPORT2015 108 FINANCIAL STATEMENTS OF THE PARENTCOMPANY DKKmillion 2015 2014 Commitments Lease commitments 1,255 1,525 Contractual obligations relating to investments in property, plant and equipment 893 244 Guarantees given forsubsidiaries 6,418 4,529 Obligations relating to researchand development projects 2,457 3,691 Other guarantees and commitments 4,523 3,879 Lease commitments expiring within the following periods from the balance sheetdate Within oneyear 209 217 Between one and fiveyears 642 681 After fiveyears 404 627 Total leasecommitments 1,255 1,525 The lease costs for 2015 and 2014 were DKK 293 million and DKK 285 million respectively. Security fordebt Land, buildings and equipment etc at carryingamount 74 80 Novo Nordisk A/S and its Danish subsidiaries are jointly taxed with the Danish companies in the NovoA/S Group. The joint taxation also covers witholding taxesintheformofdividend tax,royaltytaxand interesttax.The Danishcompanies arejointlyand individually liable forthejointtaxation.Any subsequent adjustments toincome taxesand withholding taxesmay lead to a larger liability.Thetaxforthe individual companies isallocated in full on thebasis oftheexpectedtaxableincome. Forinformation on pending litigation and other contingencies, please refer tonotes3.6and 5.3totheConsolidated financial statements. 12 OTHERPROVISIONS 15 COMMITMENTS ANDCONTINGENCIES DKKmillion 2015 2014 Non-current 717 565 Current 277 332 Total otherprovisions 994 897 Provisionsforpending litigations arerecognised asOtherprovisions. more, as part of normal business Novo Nordisk issues credit n expired goods. Consequently, a provision forfuture returnsismad onhistoricalproductreturnstatistics. For information on pending litigations, please refer to note 3. Consolidated financial statements. 13 RELATEDPARTYTRANSACTIONS Forinformation ontransactions with related parties, please referto totheConsolidated financial statements. 14 FEETOSTATUTORYAUDITORS Further- otes for e,based 6to the note5.4 DKKmillion 2015 2014 Statutory audit 8 7 Audit-relatedservices 2 6 Tax advisoryservices 3 4 Otherservices 2 3 Total fee to statutoryauditors 15 20 11 FINANCIALASSETS Amounts Investment Other securities DKKmillion Investments insubsidiaries owedby affiliates inassociated company and investments 2015 2014 Cost at the beginning of theyear 8,736 1,139 482 10,357 9,603 Investments during theyear 44 1,116 153 41 1,354 1,139 Divestments during theyear (1) (788) (156) (945) (385) Cost at the end of theyear 8,779 1,467 153 367 10,766 10,357 Value adjustments at the beginning of theyear 28,641 4 (118) 28,527 26,000 Profit/(loss) beforetax 20,719 20,719 17,077 Share of result after tax in associated companies 47 47 – Income taxes on profit for theyear (3,882) (3,882) (3,339) Amortisation and impairment – (3) Market value adjustment 351 351 – Dividendsreceived (17,408) (17,408) (11,154) Divestments during theyear (595) 123 (472) (551) Effect of exchange rateadjustment 81 (110) 17 (12) 832 Otheradjustments 153 153 (335) Value adjustments at the end of theyear 27,709 (106) 47 373 28,023 28,527 Unrealised internal profit at the beginning of theyear (19,945) (19,945) (15,755) Change for the year –charged to Incomestatement (2,037) (2,037) (2,775) Change for the year –charged toEquity – (706) Effect of exchange rateadjustment (750) (750) (709) Unrealised internal profit at the end of theyear (22,732) – – – (22,732) (19,945) Carrying amount attheendoftheyear 13,756 1,361 200 740 16,057 18,939 Carrying amount of investments in subsidiaries does not include capitalised goodwill at the end of the year. A list of companies in the Novo Nordisk Group is found in note 5.6 to the Consolidated financial statements.
NOVO NORDISK ANNUAL REPORT2015 Bagsværd, 2 February2016 ExecutiveManagement Lars FruergaardJørgensenLars Rebien Sørensen President andCEO Jesper Brandgaard CFO JakobRiis Mads Krogsgaard Thomsen Board ofDirectors GöranAndo JeppeChristiansen BrunoAngelici Chairman Vicechairman SylvieGrégoire LizHewitt LiselotteHyveled Thomas PaulKoestler EivindKolding Anne MarieKverneland Søren ThuesenPedersen Stig Strøbæk MarySzela Today, the Board of Directors and Executive Management approved the Annual Report of Novo Nordisk A/S for the year 2015. TheConsolidated financial statements have been prepared inaccordance withInternationalFinancialReportingStandardsasissuedbytheInternational Accounting Standards Board (IASB), and International Financial Reporting Standards asendorsed bytheEU.TheFinancial statements oftheparent company, Novo Nordisk A/S, have been prepared inaccordance with the DanishFinancialStatements Act. Further,theConsolidated financial statements, theFinancial statements of the parent company and Management’s Review have been prepared in accordance with additional Danish disclosure requirements for listed companies. In our opinion, the Consolidated financial statements and the Financial statements of the parent company give a true and fair view of the financial position at31 December 2015, the results of the Group’s and parentcompany’soperations,andconsolidated cashflowsforthefinancial year2015.Furthermore, inouropinion, Management’s Review includes a trueand fairaccount ofthedevelopment intheoperations andfinancial circumstances,oftheresultsfortheyear,andofthefinancialpositionof the Group and the parent company as well as a description of the most significantrisksandelementsofuncertaintyfacingtheGroupandtheparent company. Novo Nordisk’s Consolidated social and environmental statements have been prepared inaccordance with the reporting principles of materiality, inclusivityand responsiveness ofAA1000APS(2008).Theygive abalanced andreasonablepresentationoftheorganisation’ssocialandenvironmental performance. We recommend that the Annual Report be adopted at the Annual General Meeting. Management statement CONSOLIDATED FINANCIAL STATEMENTS 109 STATEMENT BY THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT ON THE ANNUALREPORT
NOVO NORDISK ANNUAL REPORT2015 Anauditinvolvesperformingprocedurestoobtainauditevidenceabout the amounts anddisclosuresintheConsolidated financial statementsand the Financial statements of the Parent Company. The procedures selected dependontheauditor’sjudgement, includingtheassessmentoftherisks of material misstatement oftheConsolidated financial statements and the FinancialstatementsoftheParentCompany, whetherduetofraud orerror. Inmaking those riskassessments, theauditor considers internal control relevanttotheCompany’spreparation ofConsolidated financial statements andFinancialstatementsoftheParentCompany thatgiveatrue andfair view in order to design audit procedures that are appropriate in the circumstances. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates madebytheManagement, aswellasevaluatingtheoverallpresentationof theConsolidated financial statements andtheFinancial statements ofthe ParentCompany. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion. Our audit has not resulted in any qualification. Opinion Inouropinion, theConsolidated financial statements giveatrueand fair viewofthefinancialpositionat31December2015oftheGroupandof the results of the Group’s operations and consolidated cash flows for the financial year 2015 in accordance with International Financial Reporting Standards asissuedbytheInternational Accounting Standards Board, and International Financial Reporting Standards as endorsed by the EU and additionalDanishdisclosurerequirementsforlistedcompanies.Moreover,in ouropiniontheFinancialstatementsoftheParentCompany giveatrueand fairviewofthefinancialpositionat31December2015andoftheresultsof theParentCompany’s operationsforthefinancial year2015 inaccordance withtheDanish Financial Statements Act andadditional Danish disclosure requirementsforlistedcompanies. STATEMENT ONMANAGEMENT’S REVIEW We have read Management’s Review, pp 1–54 and p 95 in accordance with the Danish Financial Statements Act. Onthisbasis,itisouropinionthattheinformationprovidedintheManage- ment’sReviewisconsistentwiththeConsolidated financial statementsand theFinancialstatementsoftheParent Company. Bagsværd, 2 February2016 PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab (CVR no 3377 1231) TorbenJensen State Authorised Public Accountant To the Shareholders of NovoNordisk A/S REPORTON CONSOLIDATED FINANCIAL STATEMENTS AND FINANCIAL STATEMENTS OFTHEPARENTCOMPANY Wehaveaudited theConsolidated financial statements and theFinancial statementsofNovoNordiskA/Sforthefinancialyear2015,pp55–94and pp105–108,whichcompriseIncomeStatement,BalanceSheet,Statement ofChanges inEquityandNotesincluding accounting policiesfortheGroup aswellasfortheParentCompany andStatementofComprehensive Income andCashFlowStatementfortheGroup. The Consolidated financial statements are prepared in accordance with International Financial Reporting Standards asissued bytheInternational Accounting StandardsBoard,andInternationalFinancialReportingStandards asendorsedbytheEU.TheFinancialstatementsoftheParentCompany are preparedinaccordancewiththeDanishFinancialStatementsAct.Moreover, boththeConsolidated financialstatementsandtheFinancialstatements of the Parent Company are prepared in accordance with additional Danish disclosurerequirementsforlisted companies. Management’s Responsibility for the Consolidated financial statements and the Financial statements of the ParentCompany The Management isresponsible for the preparation of the Consolidated financial statements andtheFinancial statements oftheParentCompany thatgiveatrueandfairviewinaccordance withtheabovelegislation and accounting standards, and for such internal control as Management determines isnecessary to enable preparation of Consolidated financial statements andFinancial statements oftheParentCompany thatarefree frommaterialmisstatement,whetherduetofraudor error. Auditor’s Responsibility Our responsibility isto express an opinion on the Consolidated financial statements andtheFinancial statementsoftheParentCompany based on our audit. We conducted our audit in accordance with International standards on Auditing and additional requirements under Danish Audit regulation.Thisrequiresthatwecomplywithethicalrequirementsandplan andperform theaudit toobtain reasonable assurance about whether the Consolidated financialstatementsandtheFinancialstatementsoftheParent Companyarefreefrommaterial misstatement. 110 INDEPENDENT AUDITOR’S REPORT INDEPENDENT AUDITOR’SREPORTS
NOVO NORDISK ANNUAL REPORT2015 INDEPENDENTASSURANCEREPORT 111 INDEPENDENT LIMITED ASSURANCE REPORT ON THE SOCIAL AND ENVIRONMENTAL REPORTING FOR 2015 Bagsværd, 2 February2016 PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab (CVR no 3377 1231) TorbenJensen State Authorised Public Accountant To the Stakeholders of Novo Nordisk A/S Wehaveundertaken alimitedassurance engagement oftheconsolidated socialandenvironmental information oftheAnnual Report(thereport) of NovoNordiskA/Sfor2015whichcomprisesManagement’s Review andthe Consolidated socialandenvironmental statements onpp1–54 and96– 104.Theassuranceengagement hasalsocoveredthenatureand extentof NovoNordisk’sadherencetotheAA1000 AccountAbility Principles Standard (AA1000APS (2008)) principles (inclusivity, materiality and responsiveness)withrespecttostakeholder dialogue. Novo Nordisk’s responsibility for the consolidated social and environmental information NovoNordisk’smanagement isresponsibleforadherencetotheAA1000AS (2008)Standard, preparation oftheconsolidated socialand environmental information (theinformation) in accordance with the accounting policies described on pages 97–104 and the Novo Nordisk approach towards adherence to AA1000APS (2008). This responsibility includes design, implementation andmaintenanceofinternalcontrolsrelevanttoensurethat dataarefreefrommaterialmisstatement,whetherduetofraudor error. Ourindependence and quality control We have complied with the Code of Ethics for Professional Accountants issuedbytheInternational EthicsStandards BoardforAccountants, which includes independence and other ethical requirements founded on fundamental principles of integrity, objectivity, professional competence andduecare,confidentiality andprofessional behavior.Wealsoqualify as independent as defined by the AA1000 Assurance Standard (AA1000AS(2008)). The firm applies International Standard on Quality Control 1 and accordingly maintains a comprehensive system of quality controlincluding documented policiesandproceduresregarding compliance with ethical requirements, professional standards andapplicable legal and regulatory requirements. Our work was carried out by an independent multidisciplinary team with experience in sustainability reporting and assurance. Ourresponsibility Our responsibility is to express a limited assurance conclusion on the information inthereportbasedontheprocedureswehaveperformed and the evidence we have obtained. Furthermore, our responsibility is, by applyingtheAA1000AS(2008),toexpressamoderateassuranceconclusion and make recommendations forthenature and extentofNovo Nordisk’s adherencetotheAA1000APS(2008) principles. We conducted our limited assurance engagement in accordance with International Standard on Assurance Engagements 3000, ‘Assurance Engagements other than Audits or Reviews of Historical Financial Information’,issuedbytheInternationalAuditing andAssurance Standards Board.ISAE3000 requiresthatweplanandperform thisengagement to obtain limited assurance about whether the information are free from materialmisstatement. Alimitedassuranceengagement undertaken inaccordance withISAE3000 involvesassessingthesuitabilityofNovoNordisk’suseofstatedaccounting policiesasthebasisforthepreparationoftheinformation.Furthermore, it involves assessing the risks of material misstatement of the information whetherduetofraudorerror,respondingtotheassessedrisksasnecessary in the circumstances, and evaluating the overall presentation of the information.Alimitedassurance engagement issubstantially lessinscope than a reasonable assurance engagement in relation to both the risk assessmentprocedures,including anunderstanding ofinternalcontrol,and theproceduresperformedinresponsetotheassessed risks. Moreover,wehaveplanned ourwork based ontheAA1000AS (2008)to performaType2engagement andtoobtainmoderateassuranceregarding the nature and extent of Novo Nordisk’s adherence to the principles of inclusivity,materialityand responsiveness. Theprocedures we performed were based on our professional judgment andincluded inquiries, observation ofprocessesperformed, inspection of documents, analytical procedures, evaluating the appropriateness of quantification methods andreporting policies, andagreeing orreconciling withunderlyingrecords. We conducted interviews with members of the Executive Management, Corporate Sustainability, Commercial Planning, Global Development, and Investor Relations. Also interviews with Management of the affiliate in Mexicoandanexternalstakeholderregarding NovoNordisk’scommitment andadherencetotheprinciplesofinclusivity,materialityandresponsiveness and the existence of systems and procedures to support Novo Nordisk’s TripleBottom Linegovernance and stakeholder relationships.Ourwork in particular focused on the Changing Diabetes program, Cities Changing DiabetesandtheNovoNordisk’s40by20 goal. Theproceduresperformedinalimitedassuranceengagement varyinnature and timing from, and arelessinextentthan for,areasonable assurance engagement.Consequently, the level of assurance obtained inalimited assuranceengagement issubstantiallylowerthantheassurancethatwould have been obtained had we performed areasonable assurance engage- ment.Accordingly,wedonotexpressareasonableassuranceopinionabout whether NovoNordisk’sconsolidated socialandenvironmental information havebeenprepared, inallmaterialrespects,inaccordance withthesocial andenvironmentalaccountingpoliciesappliedandstatedonpages 97–104. Limited assurance conclusion Based onthe procedures we have performed and the evidence we have obtained, nothing hascometoourattentionthatcausesustobelievethat theconsolidated socialandenvironmental information presented inNovo Nordisk’s2015 annual reportarenotprepared, inallmaterialrespects,in accordance withthesocialandenvironmentalaccounting policiesasstated onpages97–104. Furthermore, nothing has come to our attention causing us to believe that Novo Nordisk does not adhere to the AA1000APS (2008) principles. Observations and recommendations According toAA1000AS (2008), we arerequired toinclude observations and recommendations for improvements in relation to adherence to the AA1000APS (2008) principles.We have no significant recommendations regardinginclusivity,materialityand responsiveness. Regardinginclusivity Novo Nordisk continues to demonstrate a strong commitment to accountability withsystemsandprocessesinplacetosupport stakeholder engagement around sustainability issues atcorporate and affiliate levels. Stakeholder inclusivity is integrated across the business and in new initiatives.In2015,NovoNordiskhasbeenhighlyengaged intherollout of the Cities Changing Diabetes initiative which has included a formalised approachtostakeholderengagement and input. Regardingmateriality NovoNordiskcontinues todiscuss, evaluateanddetermine themateriality ofsustainability issuesonanongoing basisthrough anumber ofrelevant governance bodies and corebusiness processes, involving seniormanage- ment input from across the business. The Social and Environmental Committee with adirect responsibility for Executive Management further strengthenstheTripleBottomLinemanagementwithinthe business. Regarding responsiveness NovoNordisk’scommitment tobeing responsivetostakeholder needsand concerns isevident from Senior Management’s increasing engagement in dialogue, atbothinternational andcountrylevel,oncareandprevention of diabetes and other chronic diseases.In2015, a stronger focus has been introducedintheChanging Diabetesprogramtobetterrespondtopatients needsandtofurtherincreaseNovoNordisk’simpacton‘theruleof halves’.
PRODUCT OVERVIEW OTHER INSULIN DELIVERY SYSTEMS • PumpCart ® , NovoRapid ® cartridge to be used in pump • Cartridge • Vial INSULIN PENS • NovoPen ® 5 • NovoPen ® 4 • NovoPen ® 3 • NovoPen Echo ® , with memoryfunction NEEDLES • NovoFine ® Plus • NovoFine ® • NovoTwist ® • NovoFine ® AutoCover ORAL ANTIDIABETIC AGENTS • NovoNorm ® ,repaglinide GLUCAGON • GlucaGen ® , glucagon for diagnostic use • GlucaGen ® Hypokit, glucagon emergency kit for severe hypoglycaemia HORMONE REPLACEMENT THERAPY • Vagifem ® , estradiolhemihydrate • Activelle ® , estradiol/norethisterone acetate • Kliogest ® , estradiol/norethisterone acetate • Novofem ® , estradiol/norethisterone acetate • Trisequens ® , estradiol/norethisterone acetate • Estrofem ® ,estradiol DIABETESCARE NEW-GENERATION INSULINS • Tresiba ® , insulindegludec • Ryzodeg ® , insulin degludec/insulin aspart • Xultophy ® , insulin degludec/liraglutide GLUCAGON -LIKE PEPTIDE-1 • Victoza ® ,liraglutide MODERN INSULINS • Levemir ® , insulindetemir • NovoRapid ® , insulinaspart • NovoRapid ® PumpCart ® , pre-filled insulin pump cartridge • NovoMix ® 30, biphasic insulinaspart • NovoMix ® 50, biphasic insulinaspart • NovoMix ® 70, biphasic insulinaspart HUMAN INSULINS • Insulatard ® , isophane (NPH)insulin • Actrapid ® , regular human insulin • Mixtard ® 30, biphasic human insulin • Mixtard ® 40, biphasic human insulin • Mixtard ® 50, biphasic human insulin DIABETES DEVICES Pre-filled insulin deliverysystems • FlexTouch ® , U100,U200 • FlexPen ® • InnoLet ® OBESITY • Saxenda ® , GLP-1 analogue for weight management BIOPHARMACEUTICALS HAEMOSTASIS • NovoSeven ® , recombinant factor VIIa, also available with pre-filled syringe in an increasing number ofcountries • NovoThirteen ® , recombinant factorXIII • NovoEight ® , recombinant factorVIII HUMAN GROWTH HORMONE • Norditropin ® , somatropin (rDNAorigin) • Norditropin ® FlexPro ® , pre-filled multi-dose delivery system • Norditropin ® NordiFlex ® , pre-filled multi-dose delivery system • Norditropin ® NordiLet ® , pre-filled multi-dose delivery system • Norditropin ® SimpleXx ® , durable multi-dose delivery system • NordiPen ® • PenMate ® , automatic needle inserter, (for NordiPen ® andNordiFlex ® ) A selectionof Novo Nordisk injection devices. 112 ADDITIONALINFORMATION
MORE INFORMATION ANDREFERENCES FINANCIAL CALENDAR2016 FOR MORE NEWS FROM NOVO NORDISK, VISIT novonordisk.com/investors novonordisk.com/press novonordisk.com/sustainability FOLLOW NOVO NORDISK ON SOCIAL MEDIA facebook.com/novonordisk twitter.com/novonordisk linkedin.com/company/novo -nordisk pinterest.com/novonordisk youtube.com/novonordisk NEWS ANDUPDATES Inaddition totheAnnual Report,NovoNordiskprovidesdisclosurein separatereportstosatisfyspecific legal requirementsandstakeholder interests.Additional reportscan be downloaded from novonordisk. com/annualreport. FORM20-F Annual reporting requirement by the US Securities and Exchange Commission(SEC)forforeign privateissuerswith equity shareslisted on exchanges in the United States.Form20-Fisfiled using a stan- dardised reporting formsothat investorscan evaluate thecompany alongside USdomesticequities. CORPORATE GOVERNANCE REPORT Requirement according to the Danish Financial Statements Act. Reporting ofcompliance with DanishCorporateGovernance Recom- mendations. UNITED NATIONS GLOBAL COMPACT Voluntary Communication on Progressreporting in the form of the United Nations and its 10 principles in the areas of human rights, labour rights, environment and anti-corruption.Asa LEADmember, NovoNordiskprovides additional progress reporting on corporate sustainability leadership and UNgoals.Thisreporting also fulfils the requirements of the Danish Financial Statements Act, sections 99a and 99b, on policies and actions for corporate responsibility and progressagainst targets fordiversityinmanagement . ADDITIONALREPORTING Design and production :ADtomicCommunications.Accounts andnotes:Team2Graphics.Printing:Bording PROas, February 2016.Photography :Rasmus DanielTaun,Jesper WestleyJørgensen, UlrikJantzen, Ludmilla AudTimsdottir,Martin Juul, AndersBøggild, JesperEdvardsen, SørenSvendsen, JensLindhe. References:1.International DiabetesFederation.IDFDiabetesAtlas,7thedn.Brussels,Belgium:International DiabetesFederation2015.2.WorldHealthOrganization:Obesityandoverweight.Factsheet N 311.WorldHealthOrganization, January 2015.3.WorldFederationofHemophilia.AboutBleeding Disorders,Hemophilia.WorldFederationofHaemophilia, May2012.4.Efpia,EuropeanFederation of Pharmaceutical Industriesand Associations.http://www.efpia.eu/diseases/68/59/Growth-Problems.5.EvaluatePharma, January 2016.Dataonfile.6.UKProspectiveDiabetesStudy(UKPDS)Group. UK prospective diabetes study VIII.Study design, progressand performance.Diabetologia 1991;34:877–890.7.HartJT.RuleofHalves:implications ofincreasing diagnosis and reducing dropoutforfuture workloadandprescribingcostsinprimarycare.BrJGenPract1992;42(356):116–119andSmithWCS,LeeAJ, CrombieIK&Tunstall-PedoeH.ControlofbloodpressureinScotland:theruleofhalves.BMJ 1990;300:981–983.8.International DiabetesFederation, idf.org/about-diabetes/risk-factors9.GrayA,etal:Costeffectiveness ofanintensivebloodglucose controlpolicyinpatients withtype2diabetes: economicanalysis alongside randomised controlledtrial(UKPDS41).BMJ2000;320:1373–8.10.LiR,etal:Cost-effectiveness ofinterventions topreventandcontroldiabetes mellitus:asystematicreview. DiabetesCare 2010;33:1872–94.11.GrayA,Raikou M, McGuire A,etal.Cost-effectiveness ofan intensive blood glucose controlpolicy inpatients with type 2diabetes:economic analysis alongside randomised controlledtrial(UKPDS41).BMJ2000;320:1373–8.12.NovoNordiskA/S.Economicsimulations based ontheCOREdiabetes model2011.13.American DiabetesAssociation.Approaches to GlycemicTreatment.DiabetesCare2015;38(Supplement 1):S41–S48.14.McCullough AJ.Epidemiology ofthemetabolic syndromeintheUSA.JournalofDigestiveDiseases2011;12:333–340.15.Ogden CL,CarrollMD,KitBK&Flegal KM.PrevalenceofChildhoodandAdultObesityintheUnitedStates2011–2012.TheJournaloftheAmericanMedicalAssociation 2014;311(8):806–814.16.UnitedNations DepartmentofEconomicandSocialAffairs.WorldUrbanizationProspects,The2014Revision,Highlights2014.17.StonebrakerJS,Bolton-MaggsPHB,SoucieJM, WalkerI&BrookerM.Astudyofvariations in the reportedhaemophilia Aprevalence around the world.Haemophilia 2010;16:20–32.18.StonebrakerJS, Bolton-Maggs PHB,Michael Soucie JM, WalkerI&BrookerM. Astudy ofvariations inthe reportedhaemophilia Bprevalencearoundtheworld.Haemophilia 2012;18(3):e91–4. Marketdataonpp16,17,36and37arefromIMSHealth2015.Marketdataonp35arefromIMSHealth–MarketPrognosisGlobal,January 202016(dataonfileforlistofcountriesincluded inregions). Annual general meeting First three months Half year Firstnine months Full year ANNOUNCEMENT OF FINANCIAL RESULTS Ex-dividend Record date Payment, Bshares Payment, ADRs DIVIDEND 18 MARCH 2016 21 MARCH 2016 29 APRIL 2016 22 MARCH 2016 05 AUGUST 2016 23 MARCH 2016 28 OCTOBER 2016 30 MARCH 2016 02 FEBRUARY 2017 NOVO NORDISK ANNUAL REPORT2015 ADDITIONAL INFORMATION 113
Headquarters Novo NordiskA/S NovoAllé 2880 Bagsværd Denmark Tel +45 4444 8888 CVR number 24 25 6790 novonordisk.com Investor Service Enquiries and feedback on theAnnual Report should be addressed to: annualreport@novonordisk.com Shareholders’ enquiries concerning dividend payments andshareholder accounts should be addressed to: shareholder@novonordisk.com Aerial view of Shanghai, China. More than 23million people live in Shanghai, which is one of the partner cities in theCities Changing Diabetes programme. It is estimated that 8.3% of the city’s population has type 2 diabetes. If action isnot taken, this number is projected to grow to 15.5% by 2040. Read more about Cities Changing Diabetes on page 30. ADR holders’ enquiries concerning dividend payments, transfer of ADR certificates, consolidation of accounts andtracking of ADRs should be addressed to: JP Morgan Chase Bank,N.A. PO Box64504 4 New York Plaza, Floor12 New York, NY1004 Attention: Depositary Receipts Group Tel +1 800 990 1135 Tel +1 651 4532128 (From outside the UnitedStates) jpmorgan.adr@wellsfargo.com
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: February 10, 2016 |
NOVO NORDISK A/S
Lars Rebien Sørensen, Chief Executive Officer |