Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

x

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

 

For the quarterly period ended December 31, 2012

 

o

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

 

For the transition period from                     to                    

 

Commission File Number 000-24541

 

CORGENIX MEDICAL CORPORATION

(Exact name of registrant as specified in its Charter)

 

Nevada

 

93-1223466

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation or organization)

 

 

 

11575 Main Street, Number 400, Broomfield, CO 80020

(Address of principal executive offices, including zip code)

 

(303) 457-4345

(Registrant’s telephone number, including area code)

 

 

(Former name, former address and former fiscal year, if changed since last report)

 

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

 

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 x No o

 

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 the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer o

 

Accelerated filer o

 

 

 

Non-accelerated filer o

 

Smaller reporting company x

(Do not check if a smaller reporting company)

 

 

 

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

 

The number of shares of Common Stock outstanding was 49,828,303 as of February 5, 2013.

 

 

 



Table of Contents

 

CORGENIX MEDICAL CORPORATION

December 31, 2012

 

TABLE OF CONTENTS

 

Part I

 

 

 

 

 

Financial Information

3

 

 

 

Item 1.

Consolidated Financial Statements

3

 

 

 

Item 2.

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

14

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

20

 

 

 

Item 4.

Controls and Procedures

21

 

 

 

Part II

 

 

 

 

 

Other Information

21

 

 

 

Item 1.

Legal Proceedings

21

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

21

 

 

 

Item 3.

Defaults Upon Senior Securities

21

 

 

 

Item 4.

Mine Safety Disclosures

21

 

 

 

Item 5.

Other Information

21

 

 

 

Item 6.

Exhibits

22

 

 

 

Certifications

 

 

2



Table of Contents

 

PART I

Item 1. Consolidated Financial Statements

CORGENIX MEDICAL CORPORATION

AND SUBSIDIARIES

Consolidated Balance Sheets

(Unaudited)

 

 

 

December 31,
2012

 

June 30, 2012

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

1,232,023

 

$

1,248,537

 

Accounts receivable, less allowance for doubtful accounts of $30,000 as of December 31, 2012 and June 30, 2012

 

1,069,769

 

958,897

 

Accounts receivable from affiliates (note 12)

 

482,911

 

438,041

 

Other receivables

 

227,281

 

17,637

 

Inventories

 

2,112,842

 

2,118,669

 

Prepaid expenses

 

37,349

 

15,341

 

Total current assets

 

5,162,175

 

4,797,122

 

Equipment

 

 

 

 

 

Capitalized software costs

 

357,832

 

357,832

 

Machinery and laboratory equipment

 

1,627,335

 

1,585,687

 

Furniture, fixtures, leaseholds & office equipment

 

1,744,917

 

1,743,088

 

 

 

3,730,084

 

3,686,607

 

Accumulated depreciation and amortization

 

(2,715,379

)

(2,580,489

)

Net equipment

 

1,014,705

 

1,106,118

 

Intangible assets:

 

 

 

 

 

Licenses

 

274,147

 

288,576

 

Other assets:

 

 

 

 

 

Other assets

 

79,300

 

71,161

 

Total assets

 

$

6,530,327

 

$

6,262,977

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Current portion of notes payable, net of discount (Note 11)

 

$

32,424

 

$

38,585

 

Current portion of capital lease obligations

 

107,581

 

108,593

 

Revolving line of credit (Note 10)

 

 

 

Accounts payable

 

363,652

 

576,694

 

Accrued payroll and related liabilities

 

235,323

 

281,642

 

Accrued liabilities-other

 

141,637

 

146,970

 

Total current liabilities

 

880,617

 

1,152,484

 

Notes payable, net of discount, less current portion (Note 11)

 

5,679

 

22,240

 

Capital lease obligations, less current portion

 

50,012

 

102,020

 

Deferred facility lease payable, excluding current portion

 

345,991

 

348,104

 

Total liabilities

 

1,282,299

 

1,624,848

 

Redeemable preferred stock, $0.001par value. 36,680 shares issued and outstanding, aggregate redemption value of $9,170

 

11,738

 

11,738

 

 

 

 

 

 

 

Stockholders’ equity (Note 9):

 

 

 

 

 

Common stock, $0.001 par value. Authorized 200,000,000 shares; Issued and outstanding 49,408,092 and 47,213,534 at December 31, 2012 and June 30, 2012 respectively

 

49,408

 

47,186

 

Additional paid-in capital

 

21,545,811

 

21,183,746

 

Accumulated deficit

 

(16,358,929

)

(16,604,541

)

Total stockholders’ equity

 

5,236,290

 

4,626,391

 

Total liabilities and stockholders’ equity

 

$

6,530,327

 

$

6,262,977

 

 

See accompanying notes to consolidated financial statements.

 

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Table of Contents

 

CORGENIX MEDICAL CORPORATION

AND SUBSIDIARIES

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

December 31,
2012

 

December 31,
2011

 

December 31,
2012

 

December 31,
2011

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

2,185,191

 

$

1,725,952

 

$

4,720,858

 

$

3,605,022

 

Contract R & D and grant revenues

 

293,036

 

339,688

 

578,435

 

638,826

 

Total revenues

 

2,478,227

 

2,065,640

 

5,299,293

 

4,243,848

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues:

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

1,188,289

 

860,879

 

2,591,796

 

1,788,855

 

Cost of R & D and grant revenues

 

221,031

 

267,250

 

436,638

 

470,261

 

Total cost of revenues

 

1,409,320

 

1,128,129

 

3,028,434

 

2,259,116

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

1,068,907

 

937,511

 

2,270,859

 

1,984,732

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Selling and marketing

 

435,128

 

448,399

 

876,478

 

957,725

 

Research and development

 

98,847

 

75,167

 

226,016

 

165,258

 

General and administrative

 

479,177

 

470,667

 

908,015

 

895,576

 

Costs associated with exit or disposal activities (note 13)

 

 

 

 

17,202

 

Total expenses

 

1,013,152

 

994,233

 

2,010,509

 

2,035,761

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

55,755

 

(56,722

)

260,350

 

(51,029

)

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Other income

 

112

 

250

 

230

 

4,546

 

Interest expense

 

(5,495

)

(28,886

)

(11,894

)

(89,108

)

Total other income (expense)

 

(5,383

)

(28,636

)

(11,664

)

(84,562

)

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

50,372

 

$

(85,358

)

$

248,686

 

$

(135,591

)

Accreted dividends on redeemable preferred and redeemable common stock

 

 

5,078

 

3,074

 

10,157

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) attributable to common shareholders

 

$

50,372

 

$

(90,436

)

$

245,612

 

$

(145,748

)

 

 

 

 

 

 

 

 

 

 

Earnings (loss) per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.00

*

$

(0.00

)*

$

0.01

 

$

(0.00

)*

Diluted

 

$

0.00

*

$

(0.00

)*

$

0.01

 

$

(0.00

)*

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

48,975,498

 

45,047,166

 

48,435,612

 

43,282,141

 

Diluted

 

50,755,593

 

45,047,166

 

49,541,484

 

43,282,141

 

 

See accompanying notes to consolidated financial statements.

 


*Less than $0.00 or $ (0.01) per share

 

4



Table of Contents

 

CORGENIX MEDICAL CORPORATION

AND SUBSIDIARIES

Consolidated Statement of Stockholders’ Equity

For the six months ended December 31, 2012

(Unaudited)

 

 

 

Common
Stock,
Number
of Shares

 

Common
Stock,
$0.001
par

 

Additional
Paid-in
Capital

 

Accumulated
Deficit

 

Total
Stockholders’
Equity

 

Balances at June 30, 2012

 

47,213,534

 

$

47,186

 

$

21,183,746

 

$

(16,604,541

)

$

4,626,391

 

Issuance of common stock for services

 

187,361

 

188

 

18,548

 

 

18,736

 

Issuance of common stock for cash

 

2,034,712

 

2,034

 

303,182

 

 

305,216

 

Compensation expense recorded as a result of stock options issued

 

 

 

40,335

 

 

40,335

 

Accreted dividend on redeemable common and redeemable preferred stock

 

 

 

 

(3,074

)

(3,074

)

Cancellation of redeemable common stock upon note pay down

 

(27,515

)

 

 

 

 

Net income

 

 

 

 

248,686

 

248,686

 

Balances at December 31, 2012

 

49,408,092

 

$

49,408

 

$

21,545,811

 

$

(16,358,929

)

$

5,236,290

 

 

See accompanying notes to consolidated financial statements.

 

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Table of Contents

 

CORGENIX MEDICAL CORPORATION

AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Six months Ended

 

 

 

December 31,
2012

 

December 31,
2011

 

Cash flows from operating activities:

 

 

 

 

 

Net income (loss)

 

$

248,686

 

$

(135,591

)

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

 

 

 

 

 

Depreciation and amortization

 

149,319

 

142,203

 

Common stock issued for services

 

18,736

 

16,538

 

Compensation expense recorded for stock options issued

 

40,335

 

28,189

 

Non —cash costs associated with exit or disposal activities

 

 

49,296

 

Changes in operating assets and liabilities:

 

 

 

 

 

Trade and other receivables, net

 

(155,742

)

221,636

 

Inventories

 

5,827

 

(62,197

)

Prepaid expenses and other assets, net

 

(30,147

)

43

 

Accounts payable

 

(213,042

)

(81,457

)

Accrued payroll and related liabilities

 

(46,319

)

23,454

 

Accrued interest and other liabilities

 

(7,446

)

(58,527

)

 

 

 

 

 

 

Net cash provided by operating activities

 

10,207

 

143,587

 

 

 

 

 

 

 

Cash flows used in investing activities:

 

 

 

 

 

Additions to equipment

 

(43,477

)

(23,300

)

Net cash provided by (used in) investing activities

 

(43,477

)

(23,300

)

 

 

 

 

 

 

Cash flows provided by (used in) financing activities:

 

 

 

 

 

Increase (decrease) in amount due to factor

 

 

(791,325

)

Increase (decrease) in inventory loan

 

 

(163,460

)

Proceeds from issuance of common stock, net of financing costs

 

305,216

 

664,908

 

Proceeds received from revolving line of credit

 

3,750,924

 

3,267,930

 

Payments on revolving line of credit

 

(3,960,568

)

(3,261,728

)

Payments on notes payable

 

(25,796

)

(75,606

)

Payments on capital lease obligations

 

(53,020

)

(44,381

)

Net cash provided by (used in) financing activities

 

16,756

 

(403,662

)

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

(16,514

)

(283,375

)

Cash and cash equivalents at beginning of period

 

1,248,537

 

1,095,239

 

Cash and cash equivalents at end of period

 

$

1,232,023

 

$

811,864

 

Supplemental cash flow disclosures:

 

 

 

 

 

Cash paid for interest

 

$

11,918

 

$

91,970

 

Noncash investing and financing activities:

 

 

 

 

 

Equipment acquired under capital leases

 

$

 

$

41,520

 

Accreted dividends on redeemable common and redeemable preferred stock

 

$

3,074

 

$

10,157

 

 

See accompanying notes to consolidated financial statements.

 

6



Table of Contents

 

CORGENIX MEDICAL CORPORATION AND SUBSIDIARIES

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

1.                                      DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION

 

(a)                                 Company Overview

 

We are organized as a C corporation, were established in 1990, and our business includes research, development, manufacture, and marketing of in vitro diagnostic (“IVD”) products (tested outside the human body) for use in disease detection and diagnosis.

 

Our revenues are generated from the following:

 

·                  Sales of Manufactured Products—We manufacture and sell 52 diagnostic products on a worldwide basis to hospitals, clinical testing laboratories, universities, biotechnology and pharmaceutical companies and research institutions.

 

·                  In North America we sell our products directly through our own sales organization and through several small independent distributors.

 

·                  Outside of North America, prior to October 1, 2010, we sold our products through Corgenix UK (formerly REAADS Bio Medical Products, UK Limited), our own wholly owned subsidiary (“Corgenix UK”). Corgenix UK also managed the remainder of our international business, selling our products through independent distributors worldwide. On October 1, 2010 we transferred our international business to the ELITech Group (“ELITech”) which now serves as our international master distributor, selling our products through its wholly owned subsidiaries in addition to numerous independent distributors.

 

·                  Sales of OEM Products—We private label some of our IVD products for other diagnostic companies which they then resell worldwide through their own distribution networks. Our most important OEM customers include Bio-Rad Laboratories, Inc., Helena Laboratories and Diagnostic Grifols, S.A.

 

·                  Sales of OM Products—We purchase some products from other healthcare manufacturers which we then resell. These products include other IVD products, instruments, instrument systems and various reagents and supplies, and are primarily used to support the sale of our own manufactured products.

 

·                  Contract Manufacturing Agreements—We provide contract manufacturing services to other diagnostic and life science companies. Our most significant Contract Manufacturing customers are BG Medicine and DiaDexus.

 

·                  Contract R&D Agreements—We provide contract product development services to strategic partners and alliances. Our most significant Contract R &D customers include ELITech, Tulane University (“Tulane”) and the National Institutes of Health (“NIH”).

 

·                  Other Revenues—This segment includes shipping and other miscellaneous revenues.

 

·                  We are not dependent upon only one or a few major customers.

 

Most of our products are used in clinical laboratories for the diagnosis and/or the monitoring of three important sectors of health care:

 

·                  Autoimmune disease (diseases in which an individual creates antibodies to one’s self, for example systemic lupus erythematosus (“SLE”) and rheumatoid arthritis (“RA”),

 

·                  Vascular disease (diseases associated with certain types of thrombosis or clot formation, for example antiphospholipid syndrome, deep vein thrombosis, stroke and coronary occlusion); and

 

·                  Liver diseases (fibrosis and cirrhosis).

 

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Table of Contents

 

We are actively developing new laboratory tests in these and other important diagnostic testing areas

 

We develop and manufacture products in several commonly utilized testing formats:

 

·                  Microplate Enzyme Linked ImmunoSorbent Assay (“ELISA”)—This is a clinical testing methodology commonly used worldwide. It is a format which must be run in laboratory conditions by trained technicians, and utilizes standard microplate reading instruments. Testing is performed on a standard 96-well plastic microplate and provides quantitative results.

 

·                  Lateral Flow Immunoassay (“LFI”)—This is a rapid testing format which utilizes small strip configuration. Patient samples are applied to the end of a strip and allowed to migrate along the strip with a positive or negative indicator. Results are typically obtained in a matter of minutes and can be performed in all settings including field testing.

 

·                  Immunoturbidimetry (“IT”)—IT products are configured similar to ELISA Microplate products except that instead of coating microwell plates, this technology coats microbeads or microparticles. The assay configuration is more “automatable” than microplates, designed to be run on clinical chemistry analyzers in clinical testing laboratories by trained personnel. We use the IT format as part of our development and manufacturing agreements with ELITech.

 

Since 1990, our sales force and distribution partners have sold over 12 million tests worldwide under the REAADS and Corgenix labels, as well as OEM products. An integral part of our strategy is to work with corporate partners to develop market opportunities and access important resources including expanding our Contract Manufacturing and Contract R&D programs. We believe that our relationships with current and potential partners will enable us to enhance our menu of diagnostic products and accelerate our ability to penetrate the worldwide markets for new products.

 

We currently use the REAADS and Corgenix trademarks and trade names in the sale of the products which we manufacture. These products constitute the majority of our product sales.

 

(b)                                 Basis of Presentation

 

Financial Statement Preparation

 

The unaudited consolidated financial statements have been prepared by Corgenix according to the rules and regulations of the Securities and Exchange Commission (SEC) and, therefore, certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been omitted. The Company has evaluated subsequent events through the date the financial statements were issued.

 

In the opinion of management, the accompanying unaudited consolidated financial statements for the periods presented reflect all adjustments, which are normal and recurring, necessary to fairly state the financial position, results of operations and cash flows. These unaudited consolidated financial statements should be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2012 filed with the SEC on September 27, 2012.

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

2.                                      SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

The Company’s significant accounting policies were described in Note 1 to the audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2012. There have been no significant changes to these policies and no recent accounting pronouncements or changes in accounting pronouncements during the  three or six months ended December 31, 2012 that are of significance or potential significance to the Company.

 

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Table of Contents

 

3.                                      INVENTORIES

 

Inventories consist of raw materials, work in process and finished goods and are recorded at the lower of average cost or market, using the first-in, first-out method. A provision is recorded to reduce excess and obsolete inventories to their estimated net realizable value, when necessary. No such provision was recorded as of December 31, 2012 or June 30, 2012. Components of inventories as of December 31, 2012 and June 30, 2012 are as follows:

 

 

 

December 31,

 

June 30,

 

 

 

2012

 

2012

 

Raw materials

 

$

585,336

 

$

425,582

 

Work-in-process

 

466,458

 

785,726

 

Finished goods

 

1,061,048

 

907,361

 

 

 

$

2,112,842

 

$

2,118,669

 

 

4.                                      EARNINGS (LOSS) PER SHARE

 

Basic earnings (loss) per share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding. Diluted earnings (loss) per share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding increased for potentially dilutive common shares outstanding during the period. The dilutive effect of stock options and their equivalents is calculated using the treasury stock method. Under the treasury stock method, the diluted earnings per share denominator includes the net of new shares potentially created by unexercised in-the-money warrants and options. This method assumes that the proceeds that we receive from an in-the-money option exercise would be used to repurchase common shares in the market.

 

 

 

3 Months ended
December 31,
2012

 

3 Months ended
December 31,
2011

 

6 Months ended
December 31,
2012

 

6 Months ended
December 31,
2011

 

Net earnings (loss) attributable to common shareholders

 

$

50,372

 

$

(90,436

)

245,612

 

$

(145,748

)

Common and common equivalent shares outstanding:

 

 

 

 

 

 

 

 

 

Historical common shares outstanding at beginning of period

 

48,184,159

 

44,462,468

 

47,213,534

 

40,894,847

 

Weighted average common equivalent shares issued (retired) during the period

 

791,339

 

584,698

 

1,222,078

 

2,387,294

 

Weighted average common shares — basic

 

48,975,498

 

45,047,166

 

48,435,612

 

43,282,141

 

Dilutive potential common shares:

 

 

 

 

 

 

 

 

 

Stock options, warrants and shares of convertible preferred shares

 

1,780,095

 

 

1,105,872

 

 

Weighted average common shares and dilutive Potential common shares

 

50,755,593

 

45,047,166

 

49,541,484

 

43,282,141

 

Net income (loss) per share — basic

 

$

0.00

*

$

(0.00

)*

$

0.01

 

$

(0.00

)*

Net income (loss) per share — diluted

 

$

0.00

*

$

(0.00

)*

$

0.01

 

$

(0.00

)*

 


*Less than $0.01 or (0.01) per share

 

Options, warrants and shares of convertible preferred stock, totaling 27,470,913 shares as of December 31, 2011, were not considered in the calculation of weighted average common shares-diluted above, as their effect would be to lower the net loss per share and thus be anti-dilutive.

 

5.                                      LIQUIDITY

 

At December 31, 2012, our working capital increased by $636,920 to $4,281,558 from $3,644,638 at June 30, 2012, and concurrently, our current ratio (current assets divided by current liabilities) increased from 4.16 to 1 at June 30, 2012 to 5.86 to 1 at December 31, 2012. This increase in working capital is primarily attributable to the net income for the period in addition to the cash provided by the issuance of common stock.

 

At December 31, 2012, trade receivables were $1,552,680 versus $1,396,938 at June 30, 2012. Accounts payable, accrued payroll and other accrued expenses decreased by a combined $264,694 to $740,612 from $1,005,306 at June 30, 2012. At December 31, 2012, inventories decreased $5,827 to $2,112,842 versus $2,118,669 at June 30, 2012.

 

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For the six months ended December 31, 2012, cash provided by operating activities amounted to $10,207, versus cash provided by operating activities of $143,587 for the six months ended December 31, 2011. The decrease in the cash provided by operations for the current six month period resulted primarily from the increases in accounts receivable and decreases in accounts payable and accrued liabilities, which more than offset the increase in the net income realized for the current period.

 

Net cash used by investing activities, the purchase of laboratory equipment, leasehold improvements and computer equipment, was $43,477 for the six months ended December 31, 2012, compared to net cash used by investing activities for the six months ended December 31, 2011 totaling $23,300.

 

Net cash provided by financing activities amounted to $16,756 for the six months ended December 31, 2012 compared to net cash used by financing activities for the six months ended December 31, 2011 totaling $403,662. This increase versus the comparable prior year was primarily due to the significantly lower borrowings for the current period.

 

We have incurred operating losses and negative cash flow from operations for most of our history. Losses incurred since our inception, net of accreted dividends on redeemable common and redeemable preferred stock, have aggregated $13,956,526 and there can be no assurance that we will be able to generate positive cash flows to fund our operations in the future or to pursue our strategic objectives. Historically, we have financed our operations primarily through long-term debt, factoring of accounts receivables, and the sales of common stock, redeemable common stock, and preferred stock. We have also financed operations through sales of diagnostic products and agreements with strategic partners. We have developed and are continuing to modify an operating plan intended to eventually achieve sustainable profitability, positive cash flow from operations, and an adequate level of financial liquidity. Key components of this plan include consistent revenue growth and the cash to be derived from such growth, as well as the expansion of our strategic alliances with other biotechnology and diagnostic companies, securing diagnostic-related government contracts and grants, improving operating efficiencies to reduce our cost of sales as a percentage of sales, thereby improving gross margins, and lowering our overall operating expenses. If our sales were to decline, are flat, or achieve very slow growth, we would undoubtedly incur operating losses and a decreasing level of liquidity for that period of time. In view of this, and in order to further improve our liquidity and operating results, we entered into the ELITech collaboration and investment.

 

In summary, the cash provided by operating and financing activities was more than offset by the net cash used in investing  activities, resulting in a net decrease in cash of $16,514 for the current six month period.

 

We believe that our current working capital, in conjunction with our current revised profitable forecasts indicating profitability for the current fiscal year, should provide adequate resources to continue operations for longer than 12 months.

 

6.                                  FAIR VALUE MEASUREMENT

 

The fair value of our financial instruments reflect the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company uses a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels:

 

Level 1—quoted prices in active markets for identical assets and liabilities.

 

Level 2—observable inputs other than quoted prices in active markets for identical assets and liabilities.

 

Level 3—unobservable inputs.

 

The Company’s financial instruments are valued using quoted prices in active markets or based upon other observable inputs. The following table sets forth the fair value of the Company’s financial assets that were measured on a recurring basis as of December 31, 2012:

 

 

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Money market funds

 

$

630,035

 

$

 

$

 

$

630,035

 

Total

 

$

630,035

 

$

 

$

 

$

630,035

 

 

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7.                                      SEGMENT INFORMATION

 

The Company’s diagnostic medical products are sold in North America (the U.S., Canada and Mexico) directly and through independent sales representatives, to hospital laboratories, laboratory chains, independent laboratories, university laboratories and reference laboratories. Internationally, in prior years, its diagnostic medical products were sold wholesale through distributors, via its wholly owned subsidiary, Corgenix UK. However, commencing October 1, 2010, the Company began the process of winding down with the intent of eventually closing its international subsidiary, Corgenix UK, and its international product sales began to be executed solely through ELITech-UK, a wholly owned subsidiary of the ELITech Group, its master distributor. Consequently, it is no longer meaningful to organize its business around the two geographic segments of business: North American and International operations. For the quarters ended December 31, 2012 and December 31, 2011, the Company generated international sales to ELITech-UK amounting to $423,637 and $223,267, respectively. For the six months ended December 31, 2012 and December 31, 2011, the Company generated international sales to ELITech-UK amounting to $675,257 and $454,351, respectively, with the amount receivable from ELITech-UK at December 31, 2012 and December 31, 2011 amounting to $332,544 and $189,368, respectively.

 

8.                                      REDEEMABLE COMMON STOCK

 

(a)                             Redeemable Common Stock and Warrants

 

As previously reported, on July 1, 2002, as part of the Medical & Biological Laboratories Co., Ltd. (“MBL”) Stock Purchase Agreement (the “MBL Agreement”), MBL purchased shares of the Company’s common stock for $500,000, which were subject to MBL’s option to require the Company to repurchase at the same price in the event that a previously existing distribution agreement with RhiGene, Inc. were terminated. For no additional consideration, MBL was also issued warrants to purchase an additional 880,282 shares of Common Stock (the “Purchased Shares”) at a price of $.568 per share, which is equal to an aggregate amount of $500,000. These warrants were originally due to expire on July 3, 2009

 

On August 27, 2010, the Company entered into a Third MBL Amendment to the Common Stock Purchase Agreement and Warrant dated August 1, 2010 (the “Third MBL Amendment”) among the Company and MBL, wherein the remaining 220,070 Purchased Shares were exchanged for a two-year promissory note in the principal amount of $125,000, payable with interest at the prime rate plus two percent (the “Third MBL Note”) with payments having commenced on September 1, 2010. The Third MBL Amendment also extended the warrants to August 1, 2012. As a result of the warrant extension, an additional discount was created, which was accreted through dividends and was included as deferred financing costs on the Company’s balance sheet.

 

As of September 30, 2012, all 880,282 shares were returned to us pursuant to the three notes payable. As a result, no shares are still held as collateral for the note payable, and the warrants have now expired.

 

9.                                      STOCKHOLDERS’ EQUITY

 

(a)                                 Common Stock

 

On September 16, 2011, Wescor invested an additional $500,000 pursuant to the Third Tranche under the Common Stock Purchase Agreement and was issued 3,333,333 shares of our common stock valued at $0.15 per share. For no additional consideration we issued a warrant to Wescor to purchase 1,666,667 shares at $0.15 per share. As a condition to the closing of the Third Tranche, the Executive Committee established under the Joint Product Development Agreement has determined the feasibility of creating not less than two (2) new Corgenix assays as further described in the Joint Product Development Agreement.

 

On July 28, 2011, we entered into a First Amended Joint Product Development Agreement (the “2011 Development Agreement”) with ELITech and Wescor. Each party is responsible for its own costs, expenses and liabilities incurred under the Agreement; however, ELITech and Wescor will be responsible for expenses related to the development of new Corgenix Assays and systems. Pursuant to this agreement, each month we will notify Wescor of the amount of their stock purchase commitment, which is equal to sixty-six and 7/10 percent (66.7%) of the amount of each monthly R & D invoice at a per share price of $0.15. Wescor must purchase such shares within thirty (30) days of each notification. For the quarters ended December 31, 2012 and December 31, 2011, we generated $150,368 and $208,298, respectively in R & D revenue from Wescor, and issued 1,139,651 and 872,731 shares, respectively under this arrangement. For the six months ended December 31, 2012 and December 31, 2011, we generated $355,761 and $384,857, respectively in R & D revenue from Wescor, and issued 2,034,712 and 1,099,384 shares, respectively under this arrangement. Also, pursuant to the 2011 Development Agreement, as of December 31, 2012 and December 31, 2011 there was $150,368 and $208,298, respectively, in accounts receivable for ELITech/Wescor-funded research and development and $39,276 and $37,106 due from Wescor with respect to stock purchase commitments owing from Wescor for 261,843 and 247,473 shares, respectively, to be issued subsequent to December 31, 2012 and December 31, 2011, respectively. The $39,276 and $37,106 stock purchase commitments were not recorded as of December 31, 2012 or December 31, 2011.

 

As a result of these transactions, ELITech, including warrants, beneficially owned 45.0% of the Company’s outstanding shares as of  December 31, 2012, and is considered a related party.

 

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Table of Contents

 

(b)                                 Employee Stock Purchase Plan

 

Effective January 1, 1999, the Company adopted an Employee Stock Purchase Plan to provide eligible employees an opportunity to purchase shares of its common stock through payroll deductions, up to 10% of eligible compensation. On April 26, 2008, Shareholders approved the Company’s Second Amended and Restated Employee Stock Purchase Plan. These plans are registered under Section 423 of the Internal Revenue Code of 1986. Each quarter, participant account balances are used to purchase shares of stock at the lesser of 85% of the fair value of shares on the first business day (grant date) and last business day (exercise date) of each quarter. No right to purchase shares shall be granted if, immediately after the grant, the employee would own stock aggregating 5% or more of the total combined voting power or value of all classes of stock. A total of 600,000 common shares have been registered with the Securities and Exchange Commission (SEC) for purchase under the two plans. On January 17, 2012, at our Annual Meeting of shareholders, the shareholders voted to approve The Third Amended & Restated Employee Stock Purchase Plan, effective January 1, 2012. The maximum number of shares that may be sold under the Third Amended & Restated Employee Stock Purchase Plan is 500,000 shares, which shares have been registered with the SEC. For the three and six months ended December 31, 2012, shares issued under the plans amounted to 84,282 and 187,361, respectively. For the three and six months ended December 31, 2011, shares issued under the plans amounted to 84,244 and 174,402, respectively.

 

(c)                                  Incentive Stock Option Plan

 

Stock Options as of December 31, 2012

 

Our Amended and Restated Employee Stock Purchase Plans and the 2007 and 2011 Incentive Compensation Plans (the “Plans”) provide for two separate components. The Stock Option Grant Program, administered by the Compensation Committee (the “Committee”) appointed by our Board of Directors, provides for the grant of incentive and non-statutory stock options to purchase common stock to employees, directors or other independent advisors designated by the Committee. The Restricted Stock Program administered by the Committee, provides for the issuance of Restricted Stock Awards to employees, directors or other independent advisors designated by the Committee. The following table summarizes stock options outstanding as of December 31, 2012, and changes during the six months then ended:

 

 

 

Outstanding Options

 

 

 

Number of
Shares

 

Weighted
Average
Exercise
Price

 

Weighted
Average
Remaining
Contractual
Term (in
months)

 

Aggregate
Intrinsic
Value

 

Options outstanding at June 30, 2012

 

3,725,000

 

$

0.19

 

52.6

 

$

 

Granted

 

270,000

 

$

0.11

 

79.4

 

 

 

Exercised

 

 

$

 

 

 

 

Cancelled, expired or forfeited

 

(85,000

)

$

0.11

 

72.7

 

 

 

Options outstanding at December 31, 2012

 

3,910,000

 

$

0.20

 

28.2

 

$

 

Options exercisable at December 31, 2012

 

2,718,333

 

$

0.24

 

40.5

 

$

 

 

The total intrinsic value as of December 31, 2012 measures the difference between the market price as of December 31, 2012 and the exercise price. No options were exercised during the six months ended December 31, 2012 or December 31, 2011. Consequently, no cash was received, nor did we realize any tax deductions related to exercise of stock options during the period.

 

As of December 31, 2012, estimated unrecognized compensation cost from unvested stock options amounted to $76,914, which is expected to be recognized over a weighted average period of 69.4 months.

 

The weighted average per share fair value of stock options granted during the six months ending December 31, 2012 was $0.11. The weighted average per share fair value of stock options granted during the six months ending December 31, 2011 was $0.075. The fair value was estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions:

 

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Table of Contents

 

 

 

Quarters Ended

 

Six Months Ended

 

 

 

December 31,

 

December 31,

 

Valuation Assumptions

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

Expected life

 

7years

 

7years

 

7years

 

7 years

 

Risk-free interest rate

 

2.69

%

2.69

%

2.69

%

2.69

%

Expected volatility

 

161.5

%

113.7

%

161.5

%

135.8

%

Expected dividend yield

 

0

%

0

%

0

%

0

%

 

10.                               REVOLVING LINE OF CREDIT

 

On July 14, 2011, the Company entered into a Revolving Credit and Security Agreement (the “Loan Agreement”) with LSQ Funding Group, L.C., a Florida limited liability company (“LSQ”), which provided the Company with a $1,500,000 revolving line of credit (the “Line”).

 

Pursuant to the terms of the Loan Agreement, LSQ is providing the Line to us under which LSQ agrees to make loans to us in the maximum principal amount outstanding at any time of $1,500,000. The maximum amount of the loans under the Line shall also be governed by a borrowing base equal to 85% of Eligible Accounts Receivable plus 50% of Eligible Inventory, with certain limits and exclusions more fully set forth in the Loan Agreement.

 

Interest accrues on the average outstanding principal amount of the loans under the Line at a rate equal to 0.043% per day (15.7% APR).

 

Loans under the Line may be repaid and such repaid amounts re-borrowed until the maturity date. Unless terminated by us or accelerated by LSQ in accordance with the terms of the Loan Agreement, the Line will terminate and all loans there under must be repaid on July 14, 2013.

 

In addition, pursuant to the terms of the Loan Agreement, we granted to LSQ a security interest in all of our personal property to secure the repayment of the loans under the Line and all other of our obligations to LSQ, whether under the Loan Agreement or otherwise.

 

We have used the money we received under the Loan Agreement and the Line to pay off prior our outstanding debt obligations to Summit Financial Resources, L.P. (“Summit”), which totaled $732,487 as of July 14, 2011, the date of payment. Such payment resulted in our indebtedness and obligations owing to Summit being terminated and satisfied in full. Currently, we have made a concerted effort to minimize our use of the Line, and consequently for the quarters ended December 31, 2012 and December 31, 2011, LSQ funded a total of $1,850,415 and $1,068,288, respectively under the Line, of which $227,281 was owed us as of December 31, 2012 as opposed to $6,202 which was  outstanding as of  December 31, 2011. For the six months ended December 31, 2012 and 2011, LSQ funded a total of $3,750,924   and   $3,267,930, respectively.  Fees paid to LSQ for interest and other services for the quarters ended December 31, 2012 and 2011 totaled $415 and $18,287, respectively, and for the six months ended December 31, 2012 and 2011, totaled $924 and $53,386, respectively.

 

11.                               NOTES PAYABLE

 

Notes payable consist of the following at December 31, 2012 and June 30, 2012:

 

 

 

December 31,
2012

 

June 30, 2012

 

Note payable, net of discount of $0, unsecured, to redeemable common stockholders, with interest at prime plus 2.0% (5.25% as of June 30, 2012 due in monthly installments with principal payments of $5,200 plus interest through August 2012)

 

$

 

$

7,526

 

Installment loan payable, payable to PNC Equipment Finance, to finance upgrade of accounting software, with interest at 8.63%, due in monthly installments of $2,871 plus interest through February 2014, collateralized by certain equipment

 

38,103

 

53,299

 

 

 

38,103

 

60,825

 

Current portion, net of current portion of discount

 

(32,424

)

(38,585

)

Notes payable, excluding current portion and net of long-term portion of discount

 

$

5,679

 

$

22,240

 

 

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12.                               CONCENTRATION OF CREDIT RISK

 

The Company’s customers are principally located in the U.S. However, the ELITech Group, a French diagnostic company, via its wholly owned subsidiaries, ELITech-UK (our master international distributor) and Wescor (located in Logan, Utah), combined are considered to be a related party beneficially owning 45.0% of the Company’s outstanding shares, and  is now the Company’s largest customer. The Company performs periodic credit evaluations of its customers’ financial condition but generally does not require collateral for receivables. The ELITech group (ELITech-UK and Wescor) represented approximately 23.2% and 20.9% of total revenues in the quarters ended December 31, 2012 and December 31, 2011, respectively, approximately 19.5% and 19.3% of total revenues for the six months ended December 31, 2012 and December 31, 2011, respectively, and 30.5% and 28.4% of total accounts receivable at December 31, 2012 and December 31, 2011, respectively. The company’s international sales to ELITech-UK for the quarters ended December 31, 2012 and December 31, 2011 amounted to $423,637 and $223,267 respectively, and for the six months ended December 31, 2012 and 2011 amounted to $675,257 and $454,351, respectively.

 

13.                               COSTS ASSOCIATED WITH EXIT OR DISPOSAL ACTIVITIES

 

On July 12, 2010, the Company announced that under the terms and conditions of the distribution agreement (“Master Distribution Agreement”) with ELITech UK entered into on July 12, 2010, and as a condition precedent to the closing of the Second Tranche of the Common Stock Purchase Agreement with ELITech and Wescor, also entered into on July 12, 2010, ELITech UK became the exclusive distributor of its Products (as that term is defined therein) outside of North America. Accordingly, the Company along with Corgenix UK assigned and/or transferred the economic benefit to ELITech UK, and ELITech UK assumed all of the obligations of the Company or Corgenix UK under all distribution agreements executed by us or Corgenix UK, as the case may be, related to any distributor whose territory is outside of North America. Thus, as a condition to the closing of the Second Tranche investment with the ELITech group, it has effectively transferred its product distribution activity outside of North America from its subsidiary, Corgenix UK, to ELITech UK.

 

Pursuant to this plan, beginning October 1, 2010, the Company began winding down the business activities heretofore carried out by Corgenix UK and permanently closing the business on or about May 31, 2011. In order to accomplish this wind down and closing of Corgenix UK, the Company transferred one of Corgenix UK’s seven employees to ELITech UK, terminated the employment of all but two of the remaining Corgenix UK employees at December 31, 2011, retained one employee and one consultant until November 30, 2010, and retained the last remaining employee until December 31, 2011.

 

In connection with this reduction in workforce, the Company incurred cash charges of approximately $131,751 for one-time costs associated with the severance of these employees, which has been accounted for on a straight-line basis over the period from notification through each employee’s termination date. In addition to the above one-time charges amounting to $131,751, the Company has sold, where possible, the fixed assets, and transferred the facility lease of Corgenix UK. In that regard, the Company incurred an additional $90,237 in costs related to the loss on sale or abandonment of fixed assets, and $264,074 of charges relating to facility leases and other fixed obligations. During the three months ended December 31, 2011, Corgenix-UK was completely liquidated and all of the costs associated with exit or disposal activities have been incurred and accounted for.

 

Item 2.

 

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

 

The following discussion should be read in conjunction with the consolidated financial statements and accompanying notes included elsewhere herein.

 

(a)                                 Forward-Looking Statements

 

This 10-Q includes statements that are not purely historical and are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including statements regarding our expectations, beliefs, intentions or strategies regarding the future.  All statements other than historical fact contained in this 10-Q, including, without limitation, statements regarding future capital guidance, acquisition strategies, strategic partnership expectations, technological developments, the development, the availability of necessary components, research and development programs and distribution plans, are forward-looking statements.  All forward-looking statements included in this 10-Q are based on information available to us on the date hereof, and we assume no obligation to update such forward-looking statements.  Although we believe that the assumptions and expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to have been correct or that we will take any actions that may presently be planned.

 

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(b)           General

 

Since our inception, we have been primarily involved in the research, development, manufacturing and marketing/distribution of diagnostic tests for sale to clinical laboratories. We currently market 52 products covering autoimmune disorders, vascular diseases, infectious diseases and liver disease. Our products are sold in the United States, the UK and other countries through our marketing and sales organization that includes direct sales representatives, contract sales representatives, internationally through an extensive distributor network, and to several significant OEM partners.

 

We manufacture products for inventory based upon expected sales demand, shipping products to customers, usually within 24 hours of receipt of orders if in stock.  Accordingly, we do not operate with a significant customer order backlog.

 

Except for the fiscal years ending June 30, 1997, 2009, and 2011 we have experienced revenue growth since our inception, primarily from sales of products and contract revenues from strategic partners. Contract revenues consist of service fees from research and development agreements with strategic partners.

 

Beginning in fiscal year 1996, we began adding third-party OM licensed products to our diagnostic product line. Currently we sell 128 products licensed from or manufactured by third party manufacturers. We expect to expand our relationships with other companies in the future to gain access to additional products.

 

Although, as previously stated, we have experienced growth in revenues every year since 1990, except for 1997, 2009, and 2011, there can be no assurance that, in the future, we will sustain revenue growth, current revenue levels, or achieve or maintain profitability. Our results of operations may fluctuate significantly from period-to-period as the result of several factors, including: (i) whether and when new products are successfully developed and introduced, (ii) market acceptance of current or new products, (iii) seasonal customer demand, (iv) whether and when we receive research and development payments from strategic partners, (v) changes in reimbursement policies for the products that we sell, (vi) competitive pressures on average selling prices for the products that we sell, and (vii) changes in the mix of products that we sell.

 

(c)           Results of Operations

 

Three months ended December 31, 2012 compared to three months ended December 31, 2011

 

Total revenues. The following two tables provide the reader with further insight as to the changes in the various components of our total revenues for the comparable quarters ended December 31, 2012 and December 31, 2011.

 

 

 

Quarter ended

 

 

 

 

 

December 31,

 

% Incr.

 

 

 

2012

 

2011

 

(Decr.)

 

Total Revenues:

 

 

 

 

 

 

 

Geographical Breakdown

 

 

 

 

 

 

 

North America

 

$

2,035,654

 

$

1,733,908

 

17.4

%

International

 

$

442,573

 

$

331,732

 

33.4

%

Total Revenues

 

$

2,478,227

 

$

2,065,640

 

20.0

%

 

 

 

Quarter Ended

 

 

 

 

 

December 31,

 

% Incr.

 

 

 

2012

 

2011

 

(Decr.)

 

Total Revenues:

 

 

 

 

 

 

 

By Category

 

 

 

 

 

 

 

Phospholipid Sales*

 

$

829,937

 

$

759,194

 

9.3

%

Coagulation Sales*

 

$

269,248

 

$

368,232

 

(26.9

)%

Aspirin Works Sales

 

$

306,327

 

$

165,661

 

84.9

%

Hyaluronic Acid Sales

 

$

200,398

 

$

207,867

 

(3.6

)%

Autoimmune Sales

 

$

33,430

 

$

10,750

 

211.0

%

Contract Manufacturing

 

$

397,100

 

$

103,352

 

284.2

%

R & D Contract

 

$

293,036

 

$

339,688

 

(13.7

)%

Shipping and Other

 

$

148,751

 

$

110,896

 

34.1

%

Total Revenues

 

$

2,478,227

 

$

2,065,640

 

20.0

%

 

 


*

Includes OEM Sales

 

$

185,493

 

$

257,735

 

(28.0

)%

 

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Table of Contents

 

Cost of revenues.  Total cost of revenues, as a percentage of sales, were 56.9% for the quarter ended December 31, 2012 versus 54.6% for the prior fiscal year. The primary reasons  for the increase for the quarter were the product sales mix, which was much more heavily weighted towards lower margin sales such as contract manufacturing, OEM sales and international product sales, in addition to the increased revenue generated from contract R & D and grants, which carry a much higher cost of revenues than do our core products. The following table shows, for the quarters ended December 31, 2012 and December 31, 2011, the composition of the cost of revenues, between the cost of sales related to our core business and that the cost of revenues related to our contract research and development and grant revenues, and their relative percentage of related revenues.

 

Quarter Ended December 31, 2012

 

 

 

CORE
BUSINESS

 

R & D AND
GRANT

 

REVENUES

 

$

2,185,191

 

$

293,036

 

DIRECTLY RELATED COST OF REVENUES

 

$

1,188,289

 

$

221,031

 

COST OF REVENUES AS % OF TOTAL REVENUES

 

54.4

%

75.4

%

 

Quarter Ended December 31, 2011

 

 

 

CORE
BUSINESS

 

R & D AND
GRANT

 

REVENUES

 

$

1,725,952

 

$

339,688

 

DIRECTLY RELATED COST OF REVENUES

 

$

860,879

 

$

267,250

 

COST OF REVENUES AS % OF TOTAL REVENUES

 

49.9

%

78.7

%

 

Selling and marketing expenses.  For the quarter ended December 31, 2012, selling and marketing expenses decreased $13,271 or 3.0% to $435,128 from $448,399 for the quarter ended December 31, 2011. The $13,271 decrease versus the prior year resulted primarily from decreases of $31,813 in labor-related expenses, $16,334 trade show and travel related expenses, and $6,695 in advertising expense, partially offset by a net increase of $41,571 in other selling and marketing expenses.

 

Research and development expenses. Gross research and development expenses, prior to the reclassification of a portion of said expenses to cost of sales, decreased $29,221 or 9.6% to $275,406 for the quarter ended December 31, 2012, from $304,627 for the quarter ended December 31, 2011. The $29,221 decrease versus the prior year resulted primarily from decreases of $11,991 laboratory supplies and $3,783 in travel-related expenses, plus a net decrease of $13,447 in other research and development expenses.

 

General and administrative expenses. For the quarter ended December 31, 2012, general and administrative expenses increased $8,510 or 1.8% to $479,177 from $470,667 for the quarter ended December 31, 2011. This increase was primarily a result of a $48,796 increase in labor-related expense, partially offset by a net decrease of $40,286 for the period.

 

Interest expense. Interest expense decreased $23,391, or 81.0% to $5,495 for the quarter ended December 31, 2012, from $28,886 for the quarter ended December 31, 2011. This substantial decrease in interest expense was due primarily to the considerably lower borrowings for the current period.

 

Six months ended December 31, 2012 compared to six months ended December 31, 2011

 

Total revenues. The following two tables provide the reader with further insight as to the changes in the various components of our total revenues for the comparable six month periods ended December 31, 2012 and December 31, 2011.

 

 

 

Six months ended

 

 

 

 

 

December 31,

 

% Incr.

 

 

 

2012

 

2011

 

(Decr.)

 

Total Revenues:

 

 

 

 

 

 

 

Geographical Breakdown

 

 

 

 

 

 

 

North America

 

$

4,481,417

 

$

3,609,806

 

24.2

%

International

 

$

817,876

 

$

634,042

 

29.0

%

Total Revenues

 

$

5,299,293

 

$

4,243,848

 

24.9

%

 

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Six months Ended

 

 

 

 

 

December 31,

 

% Incr.

 

 

 

2012

 

2011

 

(Decr.)

 

Total Revenues:

 

 

 

 

 

 

 

By Category

 

 

 

 

 

 

 

Phospholipid Sales*

 

$

1,616,635

 

$

1,583,898

 

2.1

%

Coagulation Sales*

 

$

694,753

 

$

691,208

 

1.0

%

Aspirin Works Sales

 

$

491,020

 

$

320,995

 

53.0

%

Hyaluronic Acid Sales

 

$

478,270

 

$

411,401

 

16.3

%

Autoimmune Sales

 

$

59,560

 

$

46,267

 

28.7

%

Contract Manufacturing

 

$

1,092,718

 

$

281,236

 

288.5

%

R & D Contract

 

$

578,435

 

$

638,826

 

(9.5

)%

Shipping and Other

 

$

287,902

 

$

270,017

 

6.6

%

Total Revenues

 

$

5,299,293

 

$

4,243,848

 

24.9

%

 


* Includes OEM Sales

 

$

456,499

 

$

478,695

 

(4.6

)%

 

Cost of revenues.  Total cost of revenues, as a percentage of sales, were 57.1% for the six months ended December 31, 2012 versus 53.2% for the prior fiscal year. The primary reasons for the increase for the six month period were the product sales mix, which was much more heavily weighted towards lower margin sales such as contract manufacturing, OEM sales and international product sales, in addition to the increased revenue generated from contract R & D and grants, which carry a much higher cost of revenues than do our core products. The following table shows, for the six months ended December 31, 2012 and December 31, 2011, the composition of the cost of revenues, between the cost of sales related to our core business and that the cost of revenues related to our contract research and development and grant revenues, and their relative percentage of related revenues.

 

Six Months Ended December 31, 2012

 

 

 

CORE
BUSINESS

 

R & D AND
GRANT

 

REVENUES

 

$

4,720,858

 

$

578,435

 

DIRECTLY RELATED COST OF REVENUES

 

$

2,591,796

 

$

436,638

 

COST OF REVENUES AS % OF TOTAL REVENUES

 

54.9

%

75.5

%

 

Six Months Ended December 31, 2011

 

 

 

CORE
BUSINESS

 

R & D AND
GRANT

 

REVENUES

 

$

3,605,022

 

$

638,826

 

DIRECTLY RELATED COST OF REVENUES

 

$

1,788,855

 

$

470,261

 

COST OF REVENUES AS % OF TOTAL REVENUES

 

49.6

%

73.6

%

 

Selling and marketing expenses.  For the six months ended December 31, 2012, selling and marketing expenses decreased $81,247 or 8.5% to $876,478 from $957,725 for the six months ended December 31, 2011. The $81,247 decrease versus the prior year resulted primarily from decreases of $84,903 in labor-related expenses and $29,909 in trade show and travel related expenses, partially offset by a net increase of $33,565 in other selling and marketing expenses.

 

Research and development Expenses. Gross Research and development expenses, prior to the reclassification of a portion of said expenses to cost of sales, increased $70,207 or 12.0% to $654,288 for the six months ended December 31, 2012, from $584,081 for the six months ended December 31, 2011. The $70,207 increase versus the prior year resulted primarily from increases of $46,966 in labor-related expenses and $48,068 in laboratory supplies, partially offset by a net decrease of $24,827 in other research and development expenses.

 

General and administrative expenses. For the six months ended December 31, 2012, general and administrative expenses increased $12,439 or 1.4% to $908,015 from $895,576 for the six months ended December 31, 2011. The $12,439 increase versus the prior year resulted primarily from increases of $71,514 in labor-related expenses, partially offset by a net decrease of $59,075 in other general and administrative expenses.

 

Interest expense. Interest expense decreased $77,214, or 86.7% to $11,894 for the six months ended December 31, 2012, from $89,108 for the six months ended December 31, 2011. This substantial decrease in interest expense was due primarily to the considerably lower borrowings for the current period.

 

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Table of Contents

 

(d)           ADJUSTED EBITDA

 

Our adjusted earnings before interest, taxes, depreciation, amortization, non cash expense associated with stock-based compensation and the one-time costs associated with exit or disposal activities (“Adjusted EBITDA”) increased $129,909 or 385.5% to $163,606 for the quarter ended December 31, 2012 compared with $33,397 for the corresponding three month period in fiscal 2011. For the six month period ended December 31, 2012, adjusted EBITDA increased $311,540 or 198.2% to $468,740 compared with $157,200 for the corresponding six month period in fiscal 2011. Although Adjusted EBITDA is not a GAAP measure of performance or liquidity, we believe that it may be useful to an investor in evaluating our ability to meet future debt service, capital expenditures and working capital guidance. However, investors should not consider these measures in isolation or as a substitute for operating income, cash flows from operating activities or any other measure for determining our operating performance or liquidity that is calculated in accordance with GAAP. In addition, because Adjusted EBITDA is not calculated in accordance with GAAP, it may not necessarily be comparable to similarly titled measures employed by other companies. A reconciliation of Adjusted EBITDA to net earnings (loss) can be made by adding depreciation and amortization expense, corporate stock-based compensation expense, interest expense, and income tax expense to net income (loss) as in the following table:

 

 

 

3 Months ended
December 31,
2012

 

3 Months ended
December 31,
2011

 

6 Months ended
December 31,
2012

 

6 Months ended
December 31,
2011

 

RECONCILIATION OF ADJUSTED EBITDA:

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

50,372

 

$

(85,358

)

$

248,686

 

$

(135,591

)

 

 

 

 

 

 

 

 

 

 

Add back:

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

74,993

 

72,065

 

149,319

 

142,203

 

Stock-based compensation expense

 

32,858

 

18,354

 

59,071

 

44,727

 

Interest expense, net of interest income

 

5,383

 

28,636

 

11,664

 

88,659

 

Costs associated with exit or disposal activities

 

 

 

 

17,202

 

Adjusted EBITDA

 

$

163,606

 

$

33,697

 

$

468,740

 

$

157,200

 

 

(e)           Financing Agreements

 

On July 14, 2011, we entered into a Revolving Credit and Security Agreement (the “Loan Agreement”) with LSQ Funding Group, L.C., a Florida limited liability company (“LSQ”).

 

Pursuant to the terms of the Loan Agreement, LSQ is providing a line of credit (the “Line”) to us under which LSQ agrees to make loans to us in the maximum principal amount outstanding at any time of $1,500,000. The maximum amount of the loans under the Line shall also be governed by a borrowing base equal to 85% of Eligible Accounts Receivable plus 50% of Eligible Inventory, with certain limits and exclusions more fully set forth in the Loan Agreement.

 

Interest accrues on the average outstanding principal amount of the loans under the Line at a rate equal to 0.043% per day.

 

Loans under the Line may be repaid and such repaid amounts re-borrowed until the maturity date. Unless terminated by us or accelerated by LSQ in accordance with the terms of the Loan Agreement, the Line will terminate and all loans there under must be repaid on July 14, 2013.

 

The Loan Agreement contains certain representations, warranties, covenants and events of default typical in financings of this type, including, for example, limitations on additional debt and investments and limitations on the sale of additional equity by us or other changes in our ownership. Please refer to the Loan Agreement for all such representations, warranties, covenants and events of default.

 

In addition, pursuant to the terms of the Loan Agreement, we granted to LSQ a security interest in all of our personal property to secure the repayment of the loans under the Line and all other of our obligations to LSQ, whether under the Loan Agreement or otherwise.

 

We have used the money we received under the Loan Agreement and the Line to pay off our outstanding debt obligations to Summit Financial Resources, L.P. (“Summit”), which totaled $732,894 as of July 14, 2011, which was the date of payment. Such payment resulted in our indebtedness and obligations owing to Summit being terminated and satisfied in full.

 

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Table of Contents

 

In accordance with the July 10, 2010 Common Stock Purchase Agreement with ELITech and Wescor, Wescor purchased $2,000,000 of the Company’s common stock in three installments or tranches, and received warrants to purchase additional shares. Pursuant to the First Tranche of the Common Stock Purchase Agreement, on July 16, 2010, Wescor invested $1,250,000 to purchase 8,333,334 shares of the Company’s common stock valued at $0.15 per share. For no additional consideration the Company issued a warrant to Wescor to purchase 4,166,667 shares at $0.15 per share. Pursuant to the Second Tranche of the Common Stock Purchase Agreement, Wescor invested $250,000 to purchase 1,666,667 shares of our common stock valued at $0.15 per share. For no additional consideration we issued a warrant to Wescor to purchase 833,333 shares at $0.15 per share. Pursuant to the Third Tranche of the Common Stock Purchase Agreement, In July 2011, Wescor invested $500,000 to purchase 3,333,334 shares of our common stock valued at $0.15 per share. For no additional consideration we issued a warrant to Wescor to purchase 1,666,667 shares at $0.15 per share.

 

In connection with the Common Stock Purchase Agreement, at the initial closing, which occurred on July 16, 2010, we entered into the Master Distribution Agreement with ELITech UK, and we entered into the Joint Product Development Agreement with ELITech. Under the terms and conditions of the Master Distribution Agreement, and as a condition precedent to the closing of the Second Tranche, ELITech UK became the exclusive distributor of the Company’s Products (as that term is defined therein) outside of North America. Accordingly, we along with Corgenix UK assigned and/or transferred the economic benefit to ELITech UK, and ELITech UK assumed all of the obligations of the Company or Corgenix UK under all distribution agreements executed by us or Corgenix UK, as the case may be, related to any distributor whose territory is outside of North America.

 

(f)            Liquidity and Capital Resources

 

At December 31, 2012, our working capital increased by $636,920 to $4,281,558 from $3,644,638 at June 30, 2012, and concurrently, our current ratio (current assets divided by current liabilities) increased from 4.16 to 1 at June 30, 2012 to 5.86 to 1 at December 31, 2012. This increase in working capital is primarily attributable to the net income for the period in addition to the cash provided by the issuance of common stock.

 

At December 31, 2012, trade receivables were $1,552,680 versus $1,396,938 at June 30, 2012. Accounts payable, accrued payroll and other accrued expenses decreased by a combined $264,694 to $740,612 from $1,005,306 at June 30, 2012. At December 31, 2012, inventories decreased $5,827 to $2,112,842 versus $2,118,669 at June 30, 2012.

 

For the six months ended December 31, 2012, cash provided by operating activities amounted to $10,207, versus cash provided by operating activities of $143,587 for the six months ended December 31, 2011. The decrease in the cash provided by operations for the current six month period resulted primarily from the increases in accounts receivable and decreases in accounts payable and accrued liabilities, which more than offset the increase in the net income realized for the current period.

 

Net cash used by investing activities, the purchase of laboratory equipment, leasehold improvements and computer equipment, was $43,477 six months ended December 31, 2012, compared to net cash used by investing activities for the six months ended December 31, 2011 totaling $23,300.

 

Net cash provided by financing activities amounted to $16,756 for the six months ended December 31, 2012 compared to net cash used by financing activities for the six months ended December 31, 2011 totaling $403,662. This increase versus the comparable prior year was primarily due to the significantly lower borrowings for the current period.

 

We have incurred operating losses and negative cash flow from operations for most of our history. Losses incurred since our inception, net of accreted dividends on redeemable common and redeemable preferred stock, have aggregated $13,956,526 and there can be no assurance that we will be able to generate positive cash flows to fund our operations in the future or to pursue our strategic objectives. Historically, we have financed our operations primarily through long-term debt, factoring of accounts receivables, and the sales of common stock, redeemable common stock, and preferred stock. We have also financed operations through sales of diagnostic products and agreements with strategic partners. We have developed and are continuing to modify an operating plan intended to eventually achieve sustainable profitability, positive cash flow from operations, and an adequate level of financial liquidity. Key components of this plan include consistent revenue growth and the cash to be derived from such growth, as well as the expansion of our strategic alliances with other biotechnology and diagnostic companies, securing diagnostic-related government contracts and grants, improving operating efficiencies to reduce our cost of sales as a percentage of sales, thereby improving gross margins, and lowering our overall operating expenses. If our sales were to decline, are flat, or achieve very slow growth, we would undoubtedly incur operating losses and a decreasing level of liquidity for that period of time. In view of this, and in order to further improve our liquidity and operating results, we entered into the ELITech collaboration and investment.

 

In summary, the cash provided by operating and financing activities was more than offset by the net cash used in investing  activities, resulting in a net decrease in cash of $16,514 for the current six month period.

 

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Table of Contents

 

We believe that our current working capital, in conjunction with our current revised profitable forecasts indicating profitability for the current fiscal year, should provide adequate resources to continue operations for longer than 12 months.

 

(g)           Off -Balance Sheet Arrangements

 

None.

 

(h)           Contractual Obligations and Commitments

 

On February 8, 2006, we entered into a Lease Agreement (the “Lease”) with York County, LLC, a California limited liability company (“York”) pursuant to which we leased approximately 32,000 rentable square feet (the “Property”) of York’s approximately 102,400 square foot building, commonly known as Broomfield One and located at 11575 Main Street, Broomfield, Colorado 80020. In 2008, the Property was sold to The Krausz Companies, Inc. a California corporation, aka KE Denver One, LLC (the “Landlord”), and is part of Landlord’s multi-tenant real property development known as the Broomfield Corporate Center. We use the Property for our headquarters, laboratory research and development facilities and production facilities. The Lease was amended on several occasions, as previously reported.

 

On April 11, 2011, we entered into Lease Amendment No. 5 (the “Fifth Lease Amendment”) with the Landlord. The Fifth Lease Amendment extends the term of the Lease to April 30, 2019 and removes any option to further extend the Lease.

 

The Fifth Lease Amendment also adjusts the base rent (“Base Rent”) payable under the Lease.

 

·      For the period of May 1, 2011 through April 30, 2012, Base Rent was $289,600.00 per annum payable in monthly installments of $24,133.33 per month.

 

·      For the period of May 1, 2012 through April 30, 2013, Base Rent is $299,840.00 per annum payable in monthly installments of $24,986.67 per month.

 

·      For the period of May 1, 2013 through April 30, 2014, Base Rent will be $254,720.00 per annum payable in monthly installments of $21,226.67 per month.

 

·      For the period of May 1, 2014 through April 30, 2015, Base Rent will be $277,120.00 per annum payable in monthly installments of $23,093.33 per month.

 

·      For the period of May 1, 2015 through April 30, 2016, Base Rent will be $288,204.00 per annum payable in monthly installments of $24,017.00 per month.

 

·      For the period of May 1, 2016 through April 30, 2017, Base Rent will be $299,732.99 per annum payable in monthly installments of $24,977.75 per month.

 

·      For the period of May 1, 2017 through April 30, 2018, Base Rent will be $311,722.31 per annum payable in monthly installments of $25,976.86 per month.

 

·      For the period of May 1, 2018 through April 30, 2019, Base Rent will be $324,191.20 per annum payable in monthly installments of $27,015.93 per month.

 

The Fifth Lease Amendment also establishes an amount to be paid to Landlord by us in the event of a default by us under the Lease. The payment due upon default by us will be $180,000 multiplied by a fraction, the numerator of which is equal to the number of months remaining in the term of the Lease, and the denominator of which is 96.

 

We have not invested in any real estate or real estate mortgages.

 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

Not required for smaller reporting companies.

 

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Table of Contents

 

Item 4.

 

Controls and Procedures

 

Under the supervision and with the participation of our President and Chief Executive Officer and our Chief Financial Officer, our management has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report as defined in Rule 13a-15(b) or Rule 15(d)-15(e) under the Exchange Act. Based on that evaluation, the President and Chief Executive Officer and the Chief Financial Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective and ensure that information required to be disclosed in our Exchange Act reports is (1) recorded, processed, summarized and reported in a timely manner, and (2) accumulated and communicated to management, including our President and Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

There were no changes in our internal control over financial reporting that occurred during the period covered by this report that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II

 

Other Information

 

Item 1.                               Legal Proceedings

 

None

 

Item 1A.                      Risk Factors

 

Not required for smaller reporting companies.

 

Item 2.                               Unregistered Sales of Equity Securities and Use of Proceeds

 

On September 16, 2011 we received $500,000 from Wescor, pursuant to the Third Tranche under the Common Stock Purchase Agreement. Pursuant to the Common Stock Purchase Agreement, Wescor invested an additional $500,000 and is in turn to be issued 3,333,333 shares of our common stock valued at $0.15 per share. For no additional consideration we will issue a warrant to Wescor to purchase 1,666,667 shares at $0.15 per share. As a condition to the closing of the Third Tranche, the Executive Committee established under the Joint Product Development Agreement has determined the feasibility of creating not less than two (2) new Corgenix assays as further described in the Joint Product Development Agreement. The proceeds have been used for general working capital purposes. The shares and warrants offered under the Common Stock Purchase Agreement have not been registered under the Securities Act of 1933, as amended (“Securities Act”). The offer of such securities is exempt from the registration requirements of the Securities Act, pursuant to Section 4(2) of the Securities Act for transactions not involving a public offering and Rule 506 promulgated by the United States Securities and Exchange Commission under the Securities Act. A Form D was filed by the Company reporting additional information regarding the sale of the securities.

 

On July 28, 2011, we entered into a First Amended Joint Product Development Agreement (the “2011 Development Agreement”) with ELITech and Wescor. Pursuant to this agreement, each month we will notify Wescor of the amount of their stock purchase commitment, which is equal to sixty-six and 7/10 percent (66.7%) of the amount of each monthly R & D invoice at a per share price of $0.15. Wescor must purchase such shares within thirty (30) days of each notification. For the quarter and six months ended December 31, 2012, we issued 1,139,651 and 2,034,712 shares respectively under this arrangement. The proceeds have been used for general working capital purposes.

 

Item 3.                               Defaults Upon Senior Securities

 

None

 

Item 4.                               Mine Safety Disclosures

 

Not applicable

 

Item 5.                               Other Information

 

None

 

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Table of Contents

 

Item 6.          Exhibits

 

a.     Index to and Description of Exhibits.

 

Exhibit
Number

 

Description of Exhibit

 

 

 

31.1*

 

Certification of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2*

 

Certification of Chief Financial Officers pursuant to section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1*

 

Certification by Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101.INS  

 

XBRL Instance Document**

 

 

 

101.SCH  

 

XBRL Taxonomy Extension Schema Document**

 

 

 

101.CAL  

 

XBRL Taxonomy Extension Calculation Linkbase Document**

 

 

 

101.LAB  

 

XBRL Taxonomy Extension Label Linkbase Document**

 

 

 

101.PRE  

 

XBRL Taxonomy Extension Presentation Linkbase Document**

 

 

 

101.DEF  

 

XBRL Taxonomy Extension Definition Linkbase Document**

 


*

 

Filed herewith.

**

 

Furnished electronically with this report.

 

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Table of Contents

 

SIGNATURES

 

In accordance with the guidance of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

CORGENIX MEDICAL CORPORATION

 

 

 

 

 

 

February 14, 2013

 

By:

/s/ Douglass T. Simpson

 

 

 

Douglass T. Simpson

 

 

 

President and Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

 

 

 

 

By:

/s/ William H. Critchfield

 

 

 

Senior Vice President Operations and Finance and Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 

23