cutr20140930_10q.htm Table Of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 

 


FORM 10-Q

 


(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2014

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period _____ to_____.

 

Commission file number: 000-50644 

 


Cutera, Inc.

(Exact name of registrant as specified in its charter)


 

Delaware

 

77-0492262

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. employer identification no.)

 

3240 Bayshore Blvd., Brisbane, California 94005

(Address of principal executive offices)

 

(415) 657-5500

(Registrant’s telephone number, including area code)

 


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes        No    

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes      No    

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check one):

 

Large accelerated filer  

Accelerated filer  

Non-accelerated filer  

  Smaller reporting company

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.):    Yes        No    

 

The number of shares of Registrant’s common stock issued and outstanding as of October 31, 2014 was 14,395,948.

 


 
 

Table Of Contents
 

 

CUTERA, INC.

 

FORM 10-Q

 

TABLE OF CONTENTS

 

 

 

 

 

Page

PART I

 

FINANCIAL INFORMATION

 

  

 

 

 

 

  

Item 1

 

Financial Statements (unaudited)

 

3

 

 

Condensed Consolidated Balance Sheets

 

3

 

 

Condensed Consolidated Statements of Operations

 

4

 

 

Condensed Consolidated Statements of Comprehensive Loss

 

5

 

 

Condensed Consolidated Statements of Cash Flows

 

6

 

 

Notes to Condensed Consolidated Financial Statements

 

7

Item 2

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

12

Item 3

 

Quantitative and Qualitative Disclosures About Market Risk

 

19

Item 4

 

Controls and Procedures

 

19

 

 

 

 

  

PART II

 

OTHER INFORMATION

 

  

 

 

 

 

  

Item 1

 

Legal Proceedings

 

20

Item 1A

 

Risk Factors

 

20

Item 2

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

31

Item 3

 

Defaults Upon Senior Securities

 

31

Item 4

 

Mine Safety Disclosures

 

31

Item 5

 

Other Information

 

32

Item 6

 

Exhibits

 

32

 

 

Signature

 

33

 

 
2

Table Of Contents
 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1.

FINANCIAL STATEMENTS

 

CUTERA, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

 (unaudited)

 

 

   

September 30,

2014

   

December 31,

2013

 

Assets

               

Current assets:

               

Cash and cash equivalents

  $ 11,377     $ 16,242  

Marketable investments

    69,321       66,831  

Accounts receivable, net

    8,736       9,679  

Inventories

    11,106       9,006  

Deferred tax asset

    29       31  

Other current assets and prepaid expenses

    1,947       1,507  

Total current assets

    102,516       103,296  
                 

Property and equipment, net

    1,301       1,362  

Deferred tax asset, net of current portion

    316       329  

Intangibles, net

    1,438       2,019  

Goodwill

    1,339       1,339  

Other long-term assets

    13       324  

Total assets

  $ 106,923     $ 108,669  
                 

Liabilities and Stockholders' Equity

               

Current liabilities:

               

Accounts payable

  $ 2,718     $ 1,820  

Accrued liabilities

    8,975       9,328  

Deferred revenue

    8,745       7,494  

Total current liabilities

    20,438       18,642  
                 

Deferred revenue, net of current portion

    4,596       4,340  

Income tax liability

    151       108  

Other long-term liabilities

    1,029       1,314  

Total liabilities

    26,214       24,404  
                 

Commitments and Contingencies (Note 10)

               
                 

Stockholders’ equity:

               

Convertible preferred stock, $0.001 par value; authorized: 5,000,000 shares; none issued and outstanding

           

Common stock, $0.001 par value; authorized: 50,000,000 shares; issued and outstanding: 14,393,801 and 13,931,833 shares at September 30, 2014 and December 31, 2013, respectively

    14       14  

Additional paid-in capital

    104,284       98,820  

Accumulated deficit

    (23,607

)

    (14,620

)

Accumulated other comprehensive income

    18       51  

Total stockholders’ equity

    80,709       84,265  

Total liabilities and stockholders’ equity

  $ 106,923     $ 108,669  

 

The accompanying notes are an integral part of these unaudited Condensed Consolidated Financial Statements.

 

 
3

Table Of Contents
 

 

CUTERA, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 (unaudited)

 

  

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2014

   

2013

   

2014

   

2013

 

Net revenue:

                               

Products

  $ 14,409     $ 12,480     $ 39,332     $ 39,056  

Service

    4,317       4,348       13,307       13,299  

Total net revenue

    18,726       16,828       52,639       52,355  

Cost of revenue:

                               

Products

    5,877       5,490       16,871       17,063  

Service

    2,058       2,161       6,215       6,447  

Total cost of revenue

    7,935       7,651       23,086       23,510  

Gross profit

    10,791       9,177       29,553       28,845  
                                 

Operating expenses:

                               

Sales and marketing

    7,805       6,554       22,890       20,180  

Research and development

    2,628       2,440       7,894       6,778  

General and administrative

    2,897       2,160       7,796       6,803  

Total operating expenses

    13,330       11,154       38,580       33,761  

Loss from operations

    (2,539

)

    (1,977

)

    (9,027

)

    (4,916

)

Interest and other income, net

          140       218       350  

Loss before income taxes

    (2,539

)

    (1,837

)

    (8,809

)

    (4,566

)

Provision (benefit) for income taxes

    97       (169

)

    178       (97

)

Net loss

  $ (2,636

)

  $ (1,668

)

  $ (8,987

)

  $ (4,469

)

                                 

Net loss per share:

                               

Basic and Diluted

  $ (0.18

)

  $ (0.11

)

  $ (0.63

)

  $ (0.31

)

                                 

Weighted-average number of shares used in per share calculations:

                               

Basic and Diluted

    14,334       14,541       14,197       14,558  

 

 

The accompanying notes are an integral part of these unaudited Condensed Consolidated Financial Statements.

 

 
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CUTERA, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 (in thousands)

 (unaudited)

 

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2014

   

2013

   

2014

   

2013

 

Net loss

  $ (2,636

)

  $ (1,668

)

  $ (8,987

)

  $ (4,469

)

Other comprehensive income (loss):

                               

Available-for-sale investments

                               

Net change in unrealized gain (loss) on available-for-sale investments

    (57

)

    94       (29

)

    (27

)

Less: Reclassification adjustment for gains on investments recognized during the respective periods

    (3

)

    (9

)

    (4

)

    (9

)

Net change in unrealized gain (loss) on available-for-sale investments

    (60

)

    85       (33

)

    (36

)

Tax benefit

    10                    

Other comprehensive income (loss), net of tax

    (50

)

    85       (33

)

    (36

)

Comprehensive loss

  $ (2,686

)

  $ (1,583

)

  $ (9,020

)

  $ (4,505

)

 

 

The accompanying notes are an integral part of these unaudited Condensed Consolidated Financial Statements.

 

 
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CUTERA, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 (in thousands)

  (unaudited)

 

 

   

Nine Months Ended September 30,

 
   

2014

   

2013

 

Cash flows from operating activities:

               

Net loss

  $ (8,987

)

  $ (4,469

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

               

Stock-based compensation

    2,298       2,370  

Depreciation and amortization

    989       973  

Other

    222       43  

Changes in assets and liabilities:

               

Accounts receivable

    845       1,347  

Inventories

    (2,100

)

    693  

Other current assets and prepaid expenses

    (181

)

    212  

Other long-term assets

    311       49  

Accounts payable

    898       (7

)

Accrued liabilities

    (385

)

    (1,877

)

Other long-term liabilities

    (214

)

    (163 )

Deferred revenue

    1,507       1,870  

Income tax liability

    43       (343

)

Net cash provided by (used in) operating activities

    (4,754

)

    698  
                 

Cash flows from investing activities:

               

Acquisition of property, equipment and software

    (390

)

    (493

)

Proceeds from sales of marketable investments

    11,501       12,108  

Proceeds from maturities of marketable investments

    22,260       26,315  

Purchase of marketable investments

    (36,539

)

    (43,901

)

Net cash used in investing activities

    (3,168

)

    (5,971

)

                 

Cash flows from financing activities:

               

Repurchase of common stock

          (7,623

)

Proceeds from exercise of stock options and employee stock purchase plan

    3,166       4,600  

Payments on capital lease obligations

    (109

)

    (90

)

Net cash provided by (used in) financing activities

    3,057       (3,113

)

                 

Net decrease in cash and cash equivalents

    (4,865

)

    (8,386

)

Cash and cash equivalents at beginning of period

    16,242       23,546  

Cash and cash equivalents at end of period

  $ 11,377     $ 15,160  

 

 

The accompanying notes are an integral part of these unaudited Condensed Consolidated Financial Statements.

 

 
6

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CUTERA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1. Summary of Significant Accounting Policies

 

Description of Operations and Principles of Consolidation

 

Cutera®, Inc. (“Cutera” or the “Company”) is a global provider of laser and other energy-based aesthetic systems for practitioners worldwide. The Company designs, develops, manufactures, and markets laser and other energy-based product platforms for use by physicians and other qualified practitioners which enable them to offer safe and effective aesthetic treatments to their customers. The Company currently markets the following key product platforms: CoolGlide®, Xeo®, Solera®, GenesisPlus™, Excel V™, truSculpt™, Excel HR™ and enLIGHTen™. The Company’s products offer multiple hand pieces and applications, which allow customers to upgrade their systems. The sales of systems, upgrades, hand pieces, hand piece refills (Titan® and truSculpt) and the distribution of third party manufactured dermal fillers and cosmeceuticals are classified as “Product” revenue. In the second quarter of 2014, the Company terminated its agreement with Merz Pharma GmbH (“Merz”) for the distribution of its Radiesse® dermal filler product. In addition to Product revenue, the Company generates revenue from the sale of post-warranty service contracts, parts, detachable hand piece replacements (except for Titan and truSculpt) and service labor for the repair and maintenance of products that are out of warranty, all of which is classified as “Service revenue.”

 

Headquartered in Brisbane, California, the Company has wholly-owned subsidiaries that are currently operational in Australia, Belgium, Canada, France, Japan, Switzerland and Hong Kong, that market, sell and service its products outside of the United States. The Condensed Consolidated Financial Statements include the accounts of the Company and its subsidiaries. All inter-company transactions and balances have been eliminated.

 

Unaudited Interim Financial Information

 

The interim financial information filed is unaudited. The Condensed Consolidated Financial Statements included in this report reflect all adjustments (consisting only of normal recurring adjustments) that the Company considers necessary for the fair statement of the results of operations for the interim periods covered and of the financial condition of the Company at the date of the interim balance sheet. The December 31, 2013 Condensed Consolidated Balance Sheet was derived from audited financial statements, but does not include all disclosures required by generally accepted accounting principles in the United States of America (“GAAP”). The results for interim periods are not necessarily indicative of the results for the entire year or any other interim period. The Condensed Consolidated Financial Statements should be read in conjunction with the Company’s previously filed audited financial statements and the notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2013 filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2014.

 

Use of Estimates

 

The preparation of interim Condensed Consolidated Financial Statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the amounts reported and disclosed in the Condensed Consolidated Financial Statements and the accompanying notes. Actual results could differ materially from those estimates. On an ongoing basis, the Company evaluates these estimates, including those related to revenue elements, warranty obligations, sales commissions, accounts receivable and sales allowances, provision for excess and obsolete inventories, fair values of marketable investments, fair values of acquired intangible assets, useful lives of intangible assets and property and equipment, fair values of performance stock units and options to purchase the Company’s stock, recoverability of deferred tax assets, and effective income tax rates, among others. Management bases these estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.

 

Recent Accounting Pronouncements

 

In May 2014, the Financial Accountings Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, or ASU 2014-09, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The standard will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective and shall take effective on January 1, 2017. The standard permits the use of either the retrospective or cumulative effect transition method and the early application of the standard is not permitted. The Company is presently evaluating the effect that ASU 2014-09 will have on its consolidated financial statements and related disclosures and has not yet selected a transition method.

 

In August 2014, the FASB issued Accounting Standards Update No. 2014-15, Disclosure of Uncertainties About an Entity's Ability to Continue as a Going Concern. This standard update provides guidance around management's responsibility to evaluate whether there is substantial doubt about an entity's ability to continue as a going concern and to provide related footnote disclosures. The new guidance is effective for all annual and interim periods ending after December 15, 2016. The new guidance will not have an impact on the Company's consolidated financial statements.

 

Note 2. Cash, Cash Equivalents and Marketable Investments

 

The Company invests its cash primarily in money market funds, commercial paper, corporate notes and bonds, municipal bonds, and debt securities issued by the U.S. government and its agencies. The Company considers all highly liquid investments, with an original maturity of three months or less at the time of purchase, to be cash equivalents. Investments with maturities of greater than three months at the time of purchase are accounted for as “available-for-sale,” are carried at fair value with unrealized gains and losses reported as a component of stockholders’ equity, held for use in current operations and classified in current assets as “marketable investments.”

 

 
7

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The following tables summarize the components, and the unrealized gains and losses position, related to the Company’s cash and cash equivalents and marketable investments (in thousands):

 

September 30, 2014

 

Amortized

Cost

   

Gross Unrealized Gains

   

Gross Unrealized Losses

   

Fair Market Value

 

Cash and cash equivalents:

                               

Cash

  $ 4,224     $     $     $ 4,224  

Money market funds

    4,653                   4,653  

Commercial paper

    2,500                   2,500  

Total cash and cash equivalents

    11,377                   11,377  
                                 

Marketable investments:

                               

U.S. government notes

    18,340       19             18,359  

U.S. government agencies

    19,845       31       (9

)

    19,867  

Municipal securities

    3,833       3       (3

)

    3,833  

Commercial paper

    8,440       4             8,444  

Corporate debt securities

    18,795       32       (9

)

    18,818  

Total marketable investments

    69,253       89       (21

)

    69,321  
                                 

Total cash, cash equivalents and marketable investments

  $ 80,630     $ 89     $ (21

)

  $ 80,698  

 

December 31, 2013

 

Amortized

Cost

   

Gross Unrealized Gains

   

Gross Unrealized Losses

   

Fair Market Value

 

Cash and cash equivalents:

                               

Cash

  $ 3,816     $     $     $ 3,816  

Money market funds

    9,926                   9,926  

Commercial paper

    2,500                   2,500  

Total cash and cash equivalents

    16,242                   16,242  
                                 

Marketable investments:

                               

U.S. government notes

    10,516       11       (5

)

    10,522  

U.S. government agencies

    25,823       38       (3

)

    25,858  

Municipal securities

    2,043       1       (5

)

    2,039  

Commercial paper

    10,239       3             10,242  

Corporate debt securities

    18,109       61             18,170  

Total marketable investments

    66,730       114       (13

)

    66,831  
                                 

Total cash, cash equivalents and marketable investments

  $ 82,972     $ 114     $ (13

)

  $ 83,073  

 

As of September 30, 2014 and December 31, 2013, total gross unrealized losses were $21,000 and $13,000, respectively, and were related to interest rate changes on available-for-sale marketable investments. The Company has concluded that it is more-likely-than-not that the securities will be held until maturity or the recovery of their cost basis. No securities were in an unrealized loss position for more than 12 months.

 

The following table summarizes the contractual maturities of the Company’s available-for-sale securities, classified as marketable investments as of September 30, 2014 (in thousands):

 

   

Amount

 

Due in less than one year

  $ 29,091  

Due in 1 to 3 years

    40,230  
    $ 69,321  

 

 
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Note 3. Fair Value of Financial Instruments

 

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below:

 

 

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities.

 

Level 2: Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument.

 

Level 3: Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions.

 

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.

 

As of September 30, 2014, financial assets measured and recognized at fair value on a recurring basis and classified under the appropriate level of the fair value hierarchy as described above were as follows (in thousands):

 

September 30, 2014

 

Level 1

   

Level 2

   

Level 3

   

Total

 

Cash equivalents:

                               

Money market funds

  $ 4,653     $     $     $ 4,653  

Commercial paper

          2,500             2,500  

Marketable investments:

                               

Available-for-sale securities

          69,321             69,321  

Total assets at fair value

  $ 4,653     $ 71,821     $     $ 76,474  

 

As of December 31, 2013, financial assets measured and recognized at fair value on a recurring basis and classified under the appropriate level of the fair value hierarchy as described above was as follows (in thousands):

 

December 31, 2013

 

Level 1

   

Level 2

   

Level 3

   

Total

 

Cash equivalents:

                               

Money market funds

  $ 9,926     $     $     $ 9,926  

Commercial paper

          2,500             2,500  

Marketable investments:

                               

Available-for-sale securities

          66,831             66,831  

Total assets at fair value

  $ 9,926     $ 69,331     $     $ 79,257  

 

The Company’s Level 2 investments include U.S. government-backed securities and corporate securities that are valued based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. The average remaining maturity of the Company’s Level 2 investments as of September 30, 2014 is less than 36 months and all of these investments are rated by S&P and Moody’s at A- or better.

 

Note 4. Inventories

 

As of September 30, 2014 and December 31, 2013, inventories consist of the following (in thousands):

 

   

September 30,

2014

   

December 31,

2013

 

Raw materials

  $ 7,458     $ 5,989  

Finished goods

    3,648       3,017  

Total

  $ 11,106     $ 9,006  

 

 
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Note 5. Warranty

 

The Company provides a standard one-year warranty on all systems. Warranty coverage provided is for labor and parts necessary to repair the systems during the warranty period. The Company accounts for the estimated warranty cost of the standard warranty coverage as a charge to costs of revenue when revenue is recognized. The estimated warranty cost is based on historical product performance. To determine the estimated warranty reserve, the Company utilizes historical service costs to calculate the expected service expense per system and applies this to the equivalent number of units exposed under warranty. The Company updates these estimated charges every quarter.

 

The following table provides the changes in the product warranty accrual for the three and nine months ended September 30, 2014 and 2013 (in thousands):

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2014

   

2013

   

2014

   

2013

 

Beginning Balance

  $ 1,080     $ 1,049     $ 1,202     $ 1,212  

Add: Accruals for warranties issued during the period

    568       691       1,615       2,403  

Less: Settlements made during the period

    (671

)

    (682

)

    (1,840

)

    (2,557

)

Ending Balance

  $ 977     $ 1,058     $ 977     $ 1,058  

 

Note 6. Deferred Service Contract Revenue

 

The Company generates Service revenue from the sale of extended service contracts and from time and material services provided to customers who are not under a warranty or extended service contract. Service contract revenue is recognized on a straight-line basis over the period of the applicable contract. Service revenue, from customers whose systems are not under a service contract, is recognized as the services are provided.

 

The following table provides changes in the deferred service contract revenue balance for the three and nine months ended September 30, 2014 and 2013 (in thousands):

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2014

   

2013

   

2014

   

2013

 

Beginning Balance

  $ 13,001     $ 9,715     $ 11,637     $ 8,539  

Add: Payments received

    3,418       3,729       10,985       10,869  

Less: Revenue recognized

    (3,233

)

    (2,973

)

    (9,436

)

    (8,937

)

Ending Balance

  $ 13,186     $ 10,471     $ 13,186     $ 10,471  

 

Costs for extended service contracts were $1.8 million and $1.7 million for the three months ended September 30, 2014 and 2013, respectively, and $5.3 million and $5.2 million for the nine months ended September 30, 2014 and 2013, respectively.

 

Note 7. Stockholders’ Equity and Stock-based Compensation Expense

 

Stock-based Compensation Expense

 

Stock-based compensation expense by department recognized during the three and nine months ended September 30, 2014 and 2013 were as follows (in thousands):

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2014

   

2013

   

2014

   

2013

 

Cost of revenue

  $ 145     $ 159     $ 416     $ 484  

Sales and marketing

    195       182       414       579  

Research and development

    167       103       406       293  

General and administrative

    473       304       1,062       1,014  

Total stock-based compensation expense

  $ 980     $ 748     $ 2,298     $ 2,370  

 

Under the 2004 Equity Incentive Plan, as amended, the Company issued 373,722 shares of common stock during the nine months ended September 30, 2014, in conjunction with stock options exercised.

 

 
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Table Of Contents
 

 

During the nine months ended September 30, 2014, the following number of equity awards of the Company’s common stock was granted (in thousands):

 

   

Shares

 

Stock options

    431  

Restricted stock units

    211  

Performance stock units

    105

*

  

* In the third quarter of 2014, the Company granted its executive officers and certain senior management employees 105,000 Performance Stock Units ("PSU") that will vest on June 30, 2015, subject to the recipient’s continued service through that date. At the vest date, the Company will issue fully-paid up common stock, based on the achievement of three performance goals related to the degree of achievement towards pre-established targets for the Company’s revenue and operating loss improvements, compared to the same period in the prior year.

 

As of September 30, 2014, there was $4.1 million of unrecognized compensation expense, net of projected forfeitures, related to non-vested equity awards. The expense is expected to be recognized over the remaining weighted-average period of 2.7 years.

 

Note 8. Net Loss Per Share

 

Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the year. Diluted net loss per common share is the same as basic net loss per common share, as the effect of the potential common stock equivalents is anti-dilutive and as such is excluded from the calculations of the diluted net loss per share.

 

The following numbers of shares outstanding, prior to the application of the treasury stock method, were excluded from the computation of diluted net loss per common share for the periods presented because including them would have had an anti-dilutive effect (in thousands):

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2014

   

2013

   

2014

   

2013

 

Options to purchase common stock

    3,391       4,134       3,498       3,799  

Restricted stock units

    209       206       177       168  

Performance stock units

          34       3       34  

Employee stock purchase plan shares

    31       27       54       60  

Total

    3,631       4,401       3,732       4,061  

 

Note 9. Income Taxes

 

The Company’s quarterly income taxes reflect an estimate of the corresponding year’s annual effective tax rate and include, when applicable, adjustments from discrete tax items. For the three and nine months ended September 30, 2014, the Company’s tax provision was $97,000 and $178,000, respectively, compared to a tax benefit of $169,000 and $97,000 for the three and nine months ended September 30, 2013, respectively. The Company’s income tax provision for the three and nine months ended September 30, 2014 was primarily related to income taxes for the Company’s non-U.S. operations as the Company’s U.S. operations were in a loss position and the Company maintains a 100% valuation allowance for its U.S. deferred tax assets. The Company’s income tax benefit for the three and nine months ended September 30, 2013 was primarily attributable to a release of uncertain tax position reserves, partially offset by income taxes of the Company’s non-U.S. operations.

 

The Company utilizes the asset and liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statement and tax basis of assets and liabilities using tax rates expected to be in effect during the years in which the basis differences reverse. A valuation allowance is recorded when it is more likely than not that some of the deferred tax assets will not be realized. As of September 30, 2014 and December 31, 2013, the Company had a 100% valuation allowance against its U.S. deferred tax assets. Significant management judgment is required in determining any valuation allowance recorded against deferred tax assets. In evaluating the ability to recover deferred tax assets, the Company considered available positive and negative evidence giving greater weight to its recent cumulative losses and its ability to carry-back losses against prior taxable income and lesser weight to its projected financial results due to the subjectivity involved in of forecasting future periods. The Company also considered, commensurate with its objective verifiability, the forecast of future taxable income including the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies.

 

Note 10. Commitments and Contingencies

 

Litigation and Litigation Settlements

 

The Company is named from time to time as a party to product liability and contractual lawsuits in the normal course of business. The Company routinely assesses the likelihood of any adverse judgments or outcomes related to legal matters and claims, as well as ranges of probable losses. A determination of the amount of the reserves required, if any, for these contingencies is made after analysis of each known issue, historical experience, whether it is more likely than not that the Company shall incur a loss, and whether the loss is estimable. As of September 30, 2014 and December 31, 2013, the Company was not subject to any material litigation.

 

  

 
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Table Of Contents

 

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Caution Regarding Forward-Looking Statements

 

The following discussion should be read in conjunction with the attached condensed consolidated financial statements and notes thereto, and with our audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2013 as contained in our annual report on Form 10-K filed with the SEC on March 18, 2014. This quarterly report, including the following sections, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Throughout this report, and particularly in this Item 2, the forward-looking statements are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this report. In some cases, you can identify these statements by words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” and other similar terms. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements. These forward-looking statements include, but are not limited to, statements relating to our future financial performance, the ability to grow our business, increase our revenue, manage expenses, generate additional cash, achieve and maintain profitability, develop and commercialize existing and new products and applications, and improve the performance of our worldwide sales and distribution network, and the outlook regarding long term prospects. These forward-looking statements involve risks and uncertainties. The cautionary statements set forth below and those contained in Part II, Item 1A – “Risk Factors” commencing on page 20 identify important factors that could cause actual results to differ materially from those predicted in any such forward-looking statements. We caution you to not place undue reliance on these forward-looking statements, which reflect management’s analysis and expectations only as of the date of this report. We undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Form 10-Q.

 

Introduction

 

The Management’s Discussion and Analysis, or MD&A, is organized as follows:

 

 

Executive Summary. This section provides a general description and history of our business, a brief discussion of our product lines and the opportunities, trends, challenges and risks we focus on in the operation of our business.

  Critical Accounting Policies and Estimates. This section describes the key accounting policies that are affected by critical accounting estimates.
  Results of Operations. This section provides our analysis and outlook for the significant line items on our Consolidated Statements of Operations.
  Liquidity and Capital Resources. This section provides an analysis of our liquidity and cash flows, as well as a discussion of our commitments.

 

 

Executive Summary

 

Company Description.

 

We are a leading medical device company specializing in the research, development, manufacture, marketing and servicing of laser and other energy-based aesthetics systems for practitioners worldwide. We offer easy-to-use products which enable physicians and other qualified practitioners to perform safe and effective aesthetic procedures, including treatment of vascular conditions and removal of benign pigmented lesions, hair-removal, skin rejuvenation, body contouring, skin resurfacing, tattoo removal and toenail fungus. Our platforms are designed to be easily upgraded to add additional applications and hand pieces, which provide flexibility for our customers as they expand their practices. In addition to systems and upgrade revenue, we generate revenue from the sale of post warranty service contracts, providing services for products that are out of warranty, hand piece refills, and third-party manufactured dermal fillers and cosmeceuticals. In the second quarter of 2014, we terminated our agreement with Merz for the distribution of its Radiesse® dermal filler product.

 

Our corporate headquarters and U.S. operations are located in Brisbane, California, from where we conduct our manufacturing, warehousing, research and development, regulatory, sales and marketing, service, and administrative activities. We market, sell and service our products through direct sales and service employees in the U.S., Australia, Belgium, Canada, France, Japan, Switzerland and Hong Kong. Sales and Service outside of these direct markets are made through a worldwide distributor network in over 60 countries.

 

 
12

Table Of Contents
 

 

Products

 

Our revenue is derived from the sale of Products and upgrades, Service, Titan hand piece refills, and Dermal fillers and cosmeceuticals. Product and upgrade revenue includes sales of new systems and additional applications that customers purchase as their practice grows. A system consists of a console that incorporates a universal graphic user interface, a laser and/or other energy-based module, control system software, high voltage electronics and one or more hand pieces.

 

Our broad portfolio of Product brands include:

 

 

enLIGHTenTM

  Excel VTM
  Excel HRTM
  Xeo®
  truSculptTM
  GenesisPlusTM
  CoolGlide®
  Solera®
  myQTM

 

Service revenue relates to prepaid service contracts, direct billings for detachable hand piece replacements (except for Titan and truSculpt) and revenue for parts and labor on out-of-warranty products. For our Titan and truSculpt hand pieces, after a set number of treatments have been performed, the customer is required to send the hand piece back to the factory for refurbishment, which we refer to as “refilling” the hand piece. In Japan, we distribute ZO Medical Health Inc. (“ZO”) cosmeceutical products and through the second quarter of 2014, we also distributed Merz’s Radiesse® dermal filler product.

 

Significant Business Trends

 

We believe that our ability to grow revenue will be primarily dependent on the following:

 

 

Consumer demand for the applications of our products.

 

Customer (physicians) demand for our products.

 

Continuing to expand our product offerings ─ both through internal development and sourcing from other vendors.

 

Ongoing investment in our global sales and marketing infrastructure.

 

Use of clinical results to support new aesthetic products and applications.

 

Enhanced luminary development and reference selling efforts (to develop a location where our products can be displayed and used to assist in selling efforts).

 

Marketing to physicians in the core dermatology and plastic surgeon specialties, as well as outside those specialties.

 

Generating ongoing revenue from our growing installed base of customers through the sale of Service, Products and upgrades, Titan hand piece refills, and Cosmeceutical products.

 

For a detailed discussion of the significant business trends impacting our business, please see the section titled “Results of Operations” below.

 

Factors that May Impact Future Performance.

 

Our industry is impacted by numerous competitive, regulatory, macroeconomic and other significant factors. Our industry is highly competitive and our future performance depends on our ability to compete successfully. Additionally, our future performance is dependent upon our ability to continue to expand our product offerings, develop innovative technologies, obtain regulatory clearances for our products, protect the proprietary technology of our products and our manufacturing processes, manufacture our products cost-effectively, and successfully market and distribute our products in a profitable manner. If we fail to execute on the aforementioned initiatives, our business would be adversely affected. A detailed discussion of these and other factors that could impact our future performance are provided in Part II, Item 1A “Risk Factors” section below.

 

Critical Accounting Policies and Estimates.

 

The preparation of our Condensed Consolidated Financial Statements and related disclosures in conformity with GAAP requires us to make estimates, judgments and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. These estimates, judgments and assumptions are based on historical experience and on various other factors that we believe are reasonable under the circumstances. We periodically review our estimates and make adjustments when facts and circumstances dictate. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations will be affected.

 

 
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Table Of Contents
 

 

Critical accounting estimates, as defined by the SEC, are those that are most important to the portrayal of our financial condition and results of operations and require our management’s most difficult and subjective judgments and estimates of matters that are inherently uncertain. The accounting policies and estimates that we consider to be critical, subjective, and requiring judgment in their application are summarized in “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 18, 2014. There have been no significant changes to the accounting policies and estimates disclosed in our Form 10-K.

 

Results of Operations

 

The following table sets forth selected consolidated financial data for the periods indicated, expressed as a percentage of total revenue, net. Percentages in this table and throughout our discussion and analysis of financial condition and results of operations may reflect rounding adjustments.

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2014

   

2013

   

2014

   

2013

 
                                 

Net revenue

    100 %     100 %     100 %     100 %

Cost of revenue

    42 %     45 %     44 %     45 %

Gross margin

    58 %     55 %     56 %     55 %
                                 

Operating expenses:

                               

Sales and marketing

    42 %     39 %     43 %     39 %

Research and development

    14 %     15 %     15 %     13 %

General and administrative

    15 %     13 %     15 %     13 %

Total operating expenses

    71 %     67 %     73 %     65 %
                                 

Loss from operations

    (13

)%

    (12

)%

    (17

)%

    (10

)%

Interest and other income, net

    %     1 %     %     1 %

Loss before income taxes

    (13

)%

    (11

)%

    (17

)%

    (9

)%

Provision (benefit) for income taxes

    1 %     (1

)%

    %     %

Net loss

    (14

)%

    (10

)%

    (17

)%

    (9

)%

 

Total Net Revenue

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 

(Dollars in thousands)

 

2014

   

% Change

   

2013

   

2014

   

% Change

   

2013

 

Revenue mix by geography:

                                               

United States

  $ 7,607       9 %   $ 7,001     $ 21,733       3 %   $ 21,149  

International

    11,119       13 %     9,827       30,906       (1

)%

    31,206  

Consolidated total revenue

  $ 18,726       11 %   $ 16,828     $ 52,639       1 %   $ 52,355  
                                                 

United States as a percentage of total revenue

    41 %             42 %     41 %             40 %

International as a percentage of total revenue

    59 %             58 %     59 %             60 %

Revenue mix by product category:

                                               

Products and upgrades

  $ 12,922       24 %   $ 10,440     $ 33,772       3 %   $ 32,671  

Titan and truSculpt hand piece refills

    824       (11

)%

    927       2,870       (11

)%

    3,223  

Dermal fillers and cosmeceuticals

    663       (40

)%

    1,113       2,690       (15

)%

    3,162  

Total Products revenue

    14,409       15 %     12,480       39,332       1 %     39,056  

Service

    4,317       (1

)%

    4,348       13,307       %     13,299  

Consolidated total revenue

  $ 18,726       (11

)%

  $ 16,828     $ 52,639       1 %   $ 52,355  

 

 
14

Table Of Contents
 

 

Discussion of Revenue by Geography:

 

Our U.S. revenue increased by $606,000, or 9%, and by $584,000, or 3% in the three and nine months ended September 30, 2014, respectively, compared to the same periods in 2013. These increases were due primarily to an increase in sales of our Excel V and our recently launched Excel HR products, which was partially offset by declines in sales of our Xeo, truSculpt and GenesisPlus products.

 

Our international revenue increased by $1.3 million, or 13%, in the three months ended September 30, 2014, compared to the same period in 2013. This increase was due primarily to increases in revenue from our direct business in Australia, Canada and Japan as well as our European distributor countries which were partially offset by a decrease in our revenue from distributors in Asia Pacific countries. Our international revenue decreased by $300,000, or 1%, in the nine months ended September 30, 2014, compared to the same period in 2013. This decrease was due primarily to a decline in the dermal filler and cosmeceuticals revenue from Japan.

 

Discussion of Revenue by Product Type:

 

Product and Upgrade Revenue

 

As explained in more detail in the Products section of the Executive Summary above, some of our products consist of a configurable system platform that includes a console and one or more hand pieces. Each product is configured to give our customers the ability to select the combination of platform and hand pieces that provides the applications that best fit their practice.

 

Product and upgrade revenue increased by $2.5 million, or 24%, in the three months ended September 30, 2014, compared to the same period in 2013 and by $1.1 million, or 3%, in the nine months ended September 30, 2014, compared to the same period in 2013. These increases were attributable primarily to:

 

 

The continued improvement in revenue from our Excel V product

 

Revenue from our newly introduced Excel HR product; which were offset partly by

 

Reduction in revenue from our Xeo, truSculpt and GenesisPlus products

 

Titan and truSculpt Hand Piece Refill Revenue

 

Our Titan and truSculpt hand piece refill revenue decreased by $103,000, or 11%, in the three months ended September 30, 2014, and by $353,000, or 11%, in the nine months ended September 30, 2014, compared to the same periods in 2013. These decreases were due primarily to declines in Titan hand piece refill revenue, caused partially by reduced utilization and partly due to the decline in the Japanese Yen relative to the U.S. Dollar. In addition, there was a decrease in revenue from truSculpt refills due to a repositioning of the product in the third quarter of 2013 to include hand piece refills as part of the warranty of the product.

 

Dermal Filler and Cosmeceuticals Revenue

 

Our dermal filler and cosmeceuticals revenue decreased by $450,000, or 40%, in the three months ended September 30, 2014, and by $472,000, or 15%, in the nine months ended September 30, 2014, compared to the same periods in 2013. These declines were due primarily to the termination of our agreement with Merz for the distribution of their Radiesse® dermal filler product in the second quarter of 2014.

 

Service Revenue

 

Our worldwide Service revenue decreased by 1% in the three months ended September 30, 2014, and was flat in the nine months ended September 30, 2014, compared to the same periods in 2013.

 

Gross Profit

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 

(Dollars in thousands)

 

2014

   

% Change

   

2013

   

2014

   

% Change

   

2013

 

Gross profit

  $ 10,791       (18

)%

  $ 9,177     $ 29,553       2

%

  $ 28,845  

As a percentage of total net revenue

    58

%

            55

%

    56

%

            55

%

 

Our cost of revenue consists primarily of material, personnel expenses, royalty expense, product warranty costs, amortization of intangibles and manufacturing overhead expenses.

 

 
15

Table Of Contents
 

 

Gross margin was 58% and 56% in the three and nine months ended September 30, 2014, respectively, compared to 55% for both of the same periods in 2013. These gross margin improvements in the three and nine months ended September 30, 2014 were due primarily to:

 

 

Higher revenue that resulted in increased leverage;

 

Improved gross margin from our Service business, due primarily to reduced material expenses resulting from improved reliability of our products; and

 

Reduced amortization of intangibles related to the acquisition of Iridex’s aesthetic business; and

 

A shift in the product mix towards higher margin products.

 

Sales and Marketing

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 

(Dollars in thousands)

 

2014

   

% Change

   

2013

   

2014

   

% Change

   

2013

 

Sales and marketing

  $ 7,805       19

%

  $ 6,554     $ 22,890       13

%

  $ 20,180  

As a percentage of total net revenue

    42

%

            39

%

    43

%

            39

%

 

Sales and marketing expenses consist primarily of personnel expenses, expenses associated with customer-attended workshops and trade shows, post-marketing studies, and advertising. In an effort to improve our revenue, in the nine months ended September 30, 2014, we expanded our North American sales force and restructured their compensation arrangements, hired new senior sales management with prior experience in the aesthetic medical device industry, and have increased our marketing and promotional activities in North America. Given the time it takes to train new sales employees to sell our products and for the marketing efforts to yield in improved revenue, our total sales and marketing expenses increased to 43% of total net revenue in the nine months ended September 30, 2014, compared to 39% in the same period in 2013.

Sales and marketing expenses increased by $1.3 million, and represented 42% of total net revenue in the three months ended September 30, 2014, compared to 39% in the same period in 2013. The $1.3 million increase was due primarily to:

 

 

$1.1 million net increase in personnel related expenses, which were driven primarily by the expansion of our North American sales force, offset by reduced personnel expenses in Japan and in the marketing department; and

  $172,000 of increased travel and entertainment expenses due to increased headcount and sales activity.

 

Sales and marketing expenses increased by $2.7 million in the nine months ended September 30, 2014, compared to the same period in 2013. The $2.7 million increase was due primarily to:

 

 

$2.4 million net increase in personnel related expenses, which were driven primarily by the expansion of our North American sales force, offset by reduced personnel expenses in Japan and in the marketing department; and

  $370,000 of increased marketing and promotional expenses.

  

Research and Development (R&D)

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 

(Dollars in thousands)

 

2014

   

% Change

   

2013

   

2014

   

% Change

   

2013

 

Research and development

  $ 2,628       8

%

  $ 2,440     $ 7,894       16

%

  $ 6,778  

As a percentage of total net revenue

    14

%

            15

%

    15

%

            13

%

 

R&D expenses consist primarily of personnel expenses, clinical research and regulatory and material costs. R&D expenses increased by $188,000, and represented 14% of total net revenue in the three months ended September 30, 2014, compared to 15% for the same period in 2013. This increase in expense was due primarily to:

 

 

$306,000 of increased personnel related expenses; partially offset by

  144,000 of decreased material spending, which is project timing related.

 

R&D expenses increased by $1.1 million, and represented 15% of total net revenue in the nine months ended September 30, 2014, compared to 13% for the same period in 2013. The increase was due primarily to:

 

 

$604,000 of increased material spending, which is project timing dependent, related to new product development;

  $594,000 of increased personnel related expenses due to increased headcount; partially offset by
  $104,000 of decreased tools and equipment expenses.

 

General and Administrative (G&A)

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 

(Dollars in thousands)

 

2014

   

% Change

   

2013

   

2014

   

% Change

   

2013

 

General and administrative

  $ 2,897       34

%

  $ 2,160     $ 7,796       15

%

  $ 6,803  

As a percentage of total net revenue

    15

%

            13

%

    15

%

            13

%

 

 
16

Table Of Contents
 

 

G&A expenses consist primarily of personnel expenses, legal fees, accounting, audit and tax consulting fees, U.S. medical device excise tax and other general and administrative expenses. G&A expenses increased by $737,000 and represented 15% of total net revenue in the three months ended September 30, 2014, compared to 13% for the same period in 2013. This increase was due primarily to a $588,000 increase in personnel related expenses.

 

G&A expenses increased $1.0 million, and represented 15% of total net revenue in the nine months ended September 30, 2014, compared to 13% for the same period in 2013. This increase was due primarily to:

 

 

$618,000 of increased personnel related expenses; and

  $200,000 of non-recurring management consulting fees incurred in the first quarter of 2014.

 

Interest and Other Income, Net

 

Interest and other income, net, consist of the following:

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 

(Dollars in thousands)

 

2014

   

% Change

   

2013

   

2014

   

% Change

   

2013

 

Interest income

  $ 106       1 %   $ 105     $ 299       (8

)%

  $ 324  

Other income (expense), net

    (106

)

    (403

)%

    35       (81

)

    (412

)%

    26  

Total interest and other income, net

  $       (100

)%

  $ 140     $ 218       (38

)%

  $ 350  

 

Interest and other income, net, decreased $140,000 for the three months ended September 30, 2014, and decreased by $132,000 for the nine months ended September 30, 2014, compared to the same periods in 2013. These decreases were primarily attributable to net foreign exchange losses.

 

Provision (Benefit) for Income Taxes

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 

(Dollars in thousands)

 

2014

   

% Change

   

2013

   

2014

   

% Change

   

2013

 

Loss before income taxes

  $ (2,539

)

    38 %   $ (1,837

)

  $ (8,809

)

    93 %   $ (4,566

)

Provision (benefit) for income taxes

    97       (157

)%

    (169

)

    178       (284

)%

    (97

)

 

We recorded an income tax provision for the three and nine months ended September 30, 2014 of $97,000 and $178,000, respectively, compared to an income tax benefit of $169,000 and $97,000 for the three and nine months ended September 30, 2013, respectively. Our income tax provision for the three and nine months ended September 30, 2014 was primarily related to income taxes of our non-U.S. operations as our U.S. operations were in a loss position and we maintain a 100% valuation allowance for our U.S. deferred tax assets. Our income tax benefit for the three and nine months ended September 30, 2013 was primarily attributable to a release of uncertain tax positions reserves, partially offset by income taxes of our non-U.S. operations.

 

Liquidity and Capital Resources

 

Liquidity is the measurement of our ability to meet potential cash requirements, fund the planned expansion of our operations and acquire businesses. Our sources of cash include operations, stock option exercises and the liquidation of marketable investments. We actively manage our cash usage and investment of liquid cash to ensure the maintenance of sufficient funds to meet our daily needs. The majority of our cash and investments are held in U.S. banks and our foreign subsidiaries maintain a limited amount of cash in their local banks to cover their short-term operating expenses.

 

Cash, Cash Equivalents and Marketable Investments

 

The following table summarizes our cash, cash equivalents and marketable investments:

 

(Dollars in thousands)

 

September 30,

2014

   

December 31,

2013

   

Change

 

Cash and cash equivalents

  $ 11,377     $ 16,242     $ (4,865

)

Marketable investments

    69,321       66,831       2,490  

Total

  $ 80,698     $ 83,073     $ (2,375

)

 

 
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Cash Flows

 

   

Nine Months Ended

September 30,

 

(Dollars in thousands)

 

2014

   

2013

 

Net cash flow provided by (used in):

               

Operating activities

  $ (4,754

)

  $ 698  

Investing activities

    (3,168

)

    (5,971

)

Financing activities

    3,057       (3,113

)

Net decrease in cash and cash equivalents

  $ (4,865

)

  $ (8,386

)

 

Cash Flows from Operating Activities

 

Net cash used in operating activities in the nine months ended September 30, 2014 was $4.8 million, which was due primarily to:

 

 

$5.5 million used due to the net loss of $9.0 million reduced by non-cash related items of $3.5 million consisting primarily of stock-based compensation expense of $2.3 million and depreciation and amortization expenses of $1.0 million;

  $2.1 million used to increase inventory for the anticipated new product launch; offset by
  $1.5 million generated by an increase in deferred revenue primarily from the sale of service contracts to an increasing installed base of customers;
  $0.9 million generated from an increase in accounts payables; and
  $0.8 million generated from the collection of cash from the high accounts receivable balance as of December 31, 2013.

 

Net cash generated by operating activities in the nine months ended September 30, 2013 was $0.7 million, which was due primarily to:

 

 

$1.1 million used due to the net loss of $4.5 million reduced by non-cash related items of $3.4 million consisting primarily of stock-based compensation expense of $2.4 million and depreciation and amortization expenses of $1.0 million;

  $1.9 million used to pay down accrued liabilities as of December 31, 2012; partially offset by
  $1.9 million generated by an increase in deferred revenue primarily from the sale of service contracts to an increasing installed base of customers;
  $1.3 million generated from the collection of cash from the high accounts receivable balance as of December 31, 2012; and
  $0.7 million generated by a reduction in inventories.

 

Cash Flows from Investing Activities

 

We used net cash of $3.2 million in our investing activities in the nine months ended September 30, 2014, which was attributable primarily to:

 

●     $36.5 million of cash used to purchase marketable investments;

●     $0.4 million used to acquire property and equipment; partially offset by

●     $33.8 million in net proceeds from the sales and maturities of marketable investments.

 

We used net cash of $6.0 million from investing activities in the nine months ended September 30, 2013, which was attributable primarily to:

 

●     $43.9 million of cash used to purchase marketable investments;

●     $0.5 million used to acquire property and equipment; partially offset by

●     $38.4 million in net proceeds from the sales and maturities of marketable investments.

 

Cash Flows from Financing Activities

 

Net cash provided by financing activities was $3.1 million in the nine months ended September 30, 2014 and primarily consisted of proceeds from the issuance of common stock due to employees exercising their stock options and purchasing stock through the Employee Stock Purchase Plan (or “ESPP”) program.

 

Net cash used in financing activities was $3.1 million in the nine months ended September 30, 2013, which was primarily due to:

 

the repurchase of common stock for $7.6 million, partially offset by

 

proceeds from the issuance of common stock due to employees exercising their stock options and shares issued pursuant to our employee stock purchase plan of $4.6 million.

 

 
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Adequacy of cash resources to meet future needs

 

We had cash, cash equivalents, and marketable investments of $80.7 million as of September 30, 2014. For the first nine months of 2014, we financed our operations through the sales and maturities of marketable investments and cash from the sale of stock due to employees exercising their stock options and shares issued pursuant to our ESPP program. We believe the existing capital resources, including cash and cash equivalents and marketable investments of $80.7 million, are sufficient to meet our operating and capital requirements for the next several years, and enable us to repurchase up to the remaining $10.0 million of our stock pursuant to the $20.0 million share buy-back program approved by our Board.

 

Except for the recent trend of cash used to fund our operating activities, purchase fixed assets and repurchase our common stock, we are unaware of any other known trends or any known demands, commitments, events or uncertainties, including collectability of our accounts receivable, that will result in, or that are reasonably likely to result in, liquidity increasing or decreasing in any material way.

 

Commitments and Contingencies

 

There have been no material changes to our commitments and contingencies from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the SEC on March 18, 2014.

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

A summary of the key market risks facing the Company is disclosed below. For a detailed discussion, please see our Annual Report on Form 10K for the year ended December 31, 2013, filed with the SEC on March 18, 2014.

 

Our exposure to interest rate risk relates primarily to our investment portfolio, which includes primarily debt instruments of the U.S. Government and its agencies, municipal bonds, corporate bonds and commercial paper. Fixed rate securities may have their fair market value adversely impacted if there is an increase in interest rates. While it is our intent to hold these securities to maturity, if for some reason we need to sell a security that has declined in market value due to changes in interest rates, then we may suffer losses in principal. To minimize the exposure due to adverse shifts in interest rates, we maintain investments at a weighted average maturity of generally less than eighteen months. Based on discounted cash flow modeling with respect to our total investment portfolio as of September 30, 2014, assuming a hypothetical increase in interest rates of one percentage point (or 100 basis points), the fair value of our total investment portfolio would have potentially declined by approximately $413,000.

 

We do not actively hedge our exposure to currency rate fluctuations. While we transact business primarily in U.S. Dollars, and a significant proportion of our revenue is denominated in U.S. Dollars, a portion of our costs and revenue is denominated in other currencies, such as the Euro, Japanese Yen, Australian Dollar and Canadian Dollar. As a result, changes in the exchange rates of these currencies to the U.S. Dollar will affect our results from operations.

 

In the nine months ended September 30, 2014, versus the same period in 2013, the average exchange rate of the Japanese Yen versus the U.S. Dollar declined by approximately 7%. While the effect of this foreign exchange rate decline was not significant to our net operating results, it negatively impacted our Japanese Yen denominated revenue, which was offset by a favorable impact on our cost of revenue and operating expenses.

 

 ITEM 4. 

 CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Attached as exhibits to this Quarterly Report are certifications of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), which are required in accordance with Rule 13a-14 of the Securities Exchange Act of 1934, as amended (“Exchange Act”). This Controls and Procedures section includes the information concerning the controls evaluation referred to in the certifications, and it should be read in conjunction with the certifications for a more complete understanding of the topics presented.

 

We conducted an evaluation of the effectiveness of the design and operation of its disclosure controls and procedures (as defined in the Rules 13a-15(e) and 15d-15(e) under the Exchange Act) (“Disclosure Controls”) as of the end of the period covered by this Report required by Exchange Act Rules 13a-15(b) or 15d-15(b). The controls evaluation was conducted under the supervision and with the participation of our management, including the CEO and CFO. Based on this evaluation, the CEO and CFO have concluded that as of the end of the period covered by this report the disclosure controls and procedures were effective at a reasonable assurance level.

 

 
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Definition of Disclosure Controls

 

Disclosure Controls are controls and procedures designed to reasonably assure that information required to be disclosed in our reports filed under the Exchange Act, such as this Report, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure Controls are also designed to reasonably assure that such information is accumulated and communicated to our management, including the CEO and CFO, as appropriate to allow timely decisions regarding required disclosure. Our Disclosure Controls include components of internal control over financial reporting, which consists of control processes designed to provide reasonable assurance regarding the reliability of its financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles in the U.S. To the extent that components of our internal control over financial reporting are included within Disclosure Controls, they are included in the scope of our annual controls evaluation.

 

Limitations on the Effectiveness of Controls

 

Our management, including the CEO and CFO, does not expect that our disclosure controls or internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

 

We are named from time to time as a party to product liability and contractual lawsuits in the normal course of business. We routinely assess the likelihood of any adverse judgments or outcomes related to legal matters and claims, as well as ranges of probable losses. A determination of the amount of the reserves required, if any, for these contingencies is made after analysis of each known issue, historical experience, whether it is more likely than not that we shall incur a loss, and whether the loss is estimable. As of September 30, 2014, we had no material pending product liability and contractual lawsuits.

 

ITEM 1A.

RISK FACTORS

 

We operate in a rapidly changing economic and technological environment that presents numerous risks, many of which are driven by factors that we cannot control or predict. The following discussion, as well as our discussion in Management’s Discussion and Analysis of Financial Condition and Results of Operations (Item 2), highlights some of these risks. The risks described below are not exhaustive and you should carefully consider these risks and uncertainties before investing in our securities.

 

Revenue from the U.S. represents a significant part of our total revenue. In the three and nine months ended September 30, 2014, our U.S. revenue increased by approximately 9% and 3%, compared to the same periods in 2013, respectively. Unless our U.S. revenue continues to improve, we could experience a material adverse effect on our total revenue, profitability, employee retention and stock price.

 

Revenue from the U.S. represented 41% and 42% of our total revenue in the three months ended September 30, 2014 and 2013, respectively, and represented 41% and 40% of our total revenue in the nine months ended September 30, 2014 and 2013, respectively. U.S. revenue increased by approximately 9% and 3% for the three and nine months ended September 30, 2014, compared to the same periods in 2013, respectively, due to several factors, including:

 

 

In the nine months ended September 30, 2014, we have expanded our North American direct sales force, restructured their compensation arrangements, and have hired new sales management.

 

Historically, following a new product introduction, we experience revenue growth, compared to the same period in the prior year. We experienced revenue growth from our new Excel HR product launched in the second quarter of 2014 as well as continued growth of our Excel V product.

 

There can be no assurance that we will continue to introduce new products each year, or that the new product introductions will translate into increased revenue in the long term in the U.S., or that the new direct sales employees and management hired to replace the departed sales employees will be effective and result in improved sales productivity. Further, if the current economic recovery does not continue, or there is another recession in the U.S., our future revenue would be adversely impacted.

 

Given the U.S. represents a significant source of our revenue, if our U.S. revenue does not improve further, we could experience a material adverse effect on our total revenue, profitability, employee retention and stock price.

 

 
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In over five years we have only had two profitable quarters and we are unable to predict whether we will return to sustained quarterly profits in the future.

 

Although we had a profitable fourth quarter in 2009 and 2012, we have had net quarterly losses in each quarter since the third quarter of 2008. There is no guarantee that we will be profitable in the future and you should not rely on our operating results for any prior quarterly or annual periods as an indication of our future operating performance. Any predictions about the performance of our operations in the future may not be as accurate as they could be if we had a longer history of profitability.

 

Revenue growth in our business is driven by several factors and one such factor is new product introductions. While we generated revenue from sales of our newly released Excel HR product in the second and third quarters of 2014 and sales of our Excel V platform increased in 2013 and in the first nine months of 2014, compared with the respective prior year periods, sales of our truSculpt product introduced in 2012 have not gained a share of the market segment to the degree we had expected. If our total revenue does not continue to grow in 2014 compared to 2013, we may not be able to become profitable in future quarters.

 

In an effort to improve our revenue, in the nine months ended September 30, 2014, we expanded our North American sales force and restructured their compensation arrangements, hired new senior sales management with prior experience in the aesthetic medical device industry, and have increased our marketing and promotional activities in North America. Given the time it takes to train new sales employees to sell our products and for the marketing efforts to yield in improved revenue, our total sales and marketing expenses increased to 43% of total net revenue in the nine months ended September 30, 2014, compared to 39% in the same period in 2013. If our North American revenue does not increase by more than our expenses, we may not be able to become profitable in future quarters.

 

Our ability to sustain profitability depends on the extent to which we can increase revenue and control our costs in order to, among other things, counter any unforeseen difficulties, complications, product delays or other unknown factors that may require additional expenditures. Because of the numerous risks and uncertainties associated with our growth prospects, product development, sales and marketing and other efforts, we are unable to predict the extent of our future profitability or losses. If our revenue does not achieve adequate growth in the future, we may continue to incur a quarterly net loss and may continue to consume cash in our operations in the future.

 

We rely heavily on our sales professionals to market and sell our products worldwide. If we are unable to hire, effectively train, manage, improve the productivity of, and retain the sales professionals, our business will be harmed, which would impair our future revenue and profitability.

 

Our success largely depends on our ability to hire, train, manage and improve the productivity levels of our sales professionals worldwide. Because of our focus on the non-core market in the past, several of our sales professionals do not have established relationships with core market physicians (dermatologists and plastic surgeons) or where those relationships exist, they are not very strong.

 

We have experienced direct sales employee and sales management turnover in North America for several reasons. One such reason was the consolidation of our specialty podiatry sales force into the mainstream aesthetic sales group in the third quarter of 2013. Further, competition for sales professionals who are familiar and trained to sell in the aesthetic equipment market continues to be strong. As a result, we have lost some of our sales people to our competitors. However, we have also hired a record number of new sales people, including several from our competitors. Several of our sales employees and sales management have been recently hired or recently transferred into different roles, and it will take time for them to be fully trained to improve their productivity. These factors have heavily impacted the revenue we derived from our products and upgrades in the first nine months of fiscal 2014.

 

In 2013, and in the nine months of 2014, we restructured our North American direct sales force and sales management. In the nine months ended September 30, 2014, we have expanded our direct sales force in North America. We have increased our efforts to hire high quality experienced sales professionals but there can be no guarantee that we will be able to retain all of the hired sales professionals or that they will all become productive in a short period of time. Our industry is characterized by a few established companies that compete vigorously for talented sales professionals. Further, as the economy in North America has rebounded from the recent recession, some of those sales professionals have left our Company for jobs that they perceive to be better opportunities, both within and outside of the aesthetic industry. We believe that the sales employee turnover, restructuring and expansion of the sales force had a negative impact on our North A