1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) __X__ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the quarterly period ended June 30, 1996. _____ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from_____ to_____. Commission File Number: 0-19749 CHEMTRAK INCORPORATED Delaware 77-0295388 (State or other jurisdiction of (I.R.S Employer Identification No.) incorporation or organization) 929 E. Arques Avenue, Sunnyvale, CA 94086 (Address of principal executive offices) Registrant's telephone number, including area code: (408) 773-8156 Securities registered pursuant to Section 12(g) of the Act: Common Stock $.001 par value (Title of Class) 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 __X__ No ______ Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Class: Common Stock $.001 par value Outstanding at July 31, 1996: 9,982,690 2 CHEMTRAK INCORPORATED INDEX PART I. FINANCIAL INFORMATION PAGE ---- NO. ---- Item 1: Financial Statements Condensed Balance Sheets as of June 30, 1996 and December 31, 1995 3 Condensed Statements of Operations for the three and six months ended June 30, 1996 and 1995 4 Condensed Statements of Cash Flows for the six months ended June 30, 1996 and 1995 5 Notes to Condensed Financial Statements 6 Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations 7-9 PART II. OTHER INFORMATION Item 4: Submission of Matters to a Vote of Security-Holders 10 Item 6: Exhibits and Reports on Form 8-K 11 SIGNATURES 12 EXHIBITS 13 2 3 CHEMTRAK INCORPORATED CONDENSED BALANCE SHEETS (UNAUDITED) ASSETS June 30, 1996 December 31, 1995 ------------- ----------------- (unaudited) Current assets: Cash and cash equivalents $ 5,989,000 $ 4,251,000 Short-term investments 1,489,000 2,003,000 Accounts receivable, net 500,000 136,000 Inventories 700,000 434,000 Prepaid expenses and other current assets 415,000 245,000 ------------ ------------ Total current assets 9,093,000 7,069,000 Property and equipment, net 3,009,000 3,248,000 Other assets 66,000 66,000 ------------ ------------ Total assets $ 12,168,000 $ 10,383,000 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 449,000 $ 632,000 Accrued payroll and benefits 157,000 121,000 Other accrued liabilities 560,000 258,000 Accrued royalties 161,000 114,000 ------------ ------------ Total current liabilities 1,327,000 1,125,000 Accrued rent 268,000 240,000 Convertible debentures 5,000,000 0 Stockholders' equity: Common stock 10,000 10,000 Additional paid-in capital 37,733,000 37,528,000 Deferred compensation (59,000) (38,000) Accumulated deficit (32,111,000) (28,482,000) ------------ ------------ Total stockholders' equity 5,573,000 9,018,000 ------------ ------------ Total liabilities and stockholders' equity $ 12,168,000 $ 10,383,000 ============ ============ See accompanying notes. 3 4 CHEMTRAK INCORPORATED CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) Three months ended Six months ended June 30, June 30, ------------------------------ ------------------------------ 1996 1995 1996 1995 ----------- ----------- ----------- ----------- Net revenues: Product sales $ 581,000 $ 238,000 $ 1,437,000 $ 1,664,000 Funded research and other revenues 25,000 520,000 175,000 910,000 ----------- ----------- ----------- ----------- Total net revenues 606,000 758,000 1,612,000 2,574,000 Cost and expenses: Cost of product sales 824,000 640,000 1,555,000 2,037,000 Research and development 729,000 658,000 1,473,000 1,250,000 Marketing, general and administrative 1,179,000 650,000 2,273,000 1,427,000 Purchase of in-process research and development -- -- -- 1,500,000 ----------- ----------- ----------- ----------- Total costs and expenses 2,732,000 1,948,000 5,301,000 6,214,000 ----------- ----------- ----------- ----------- Operating loss (2,126,000) (1,190,000) (3,689,000) (3,640,000) Net interest income and expense (7,000) 75,000 60,000 158,000 ----------- ----------- ----------- ----------- Net Income (loss) $(2,133,000) $(1,115,000) $(3,629,000) $(3,482,000) =========== =========== =========== =========== Net income (loss) per share $ (0.22) $ (0.12) $ (0.37) $ (0.36) =========== =========== =========== =========== Shares used in calculating per share amounts 9,773,000 9,660,000 9,743,000 9,587,000 =========== =========== =========== =========== See accompanying notes. 4 5 CHEMTRAK INCORPORATED CONDENSED STATEMENTS 0F CASH FLOWS INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (UNAUDITED) Six months ended June 30, ------------------------------ 1996 1995 ----------- ----------- Operating activities: Net loss $(3,629,000) $(3,482,000) Adjustment to reconcile net loss to net cash and cash equivalents used in operating activities: Depreciation and amortization 430,000 423,000 Accrued rent 27,000 27,000 Stock option compensation and other 2,000 (48,000) Purchase of in-process research and development for common stock 0 900,000 Changes in operating assets and liabilities: Accounts receivable (364,000) 436,000 Inventories (266,000) 563,000 Prepaid expenses and other current assets (170,000) 160,000 Accounts payable (183,000) (434,000) Accrued payroll and benefits 36,000 (411,000) Other accrued liabilities 349,000 (140,000) ----------- ----------- Net cash and cash equivalents provided by (used in) operating activities (3,768,000) (2,006,000) ----------- ----------- Investing activities: Proceeds from available-for-sale securities 514,000 3,000,000 Aquisition of property and equipment, net (190,000) (85,000) ----------- ----------- Net cash and cash equivalents provided by (used in) investing activities 324,000 2,915,000 ----------- ----------- Financing activities: Issuance of convertible debentures 5,000,000 0 Issuance of common stock 182,000 119,000 ----------- ----------- Net cash and cash equivalents provided by financing activities 5,182,000 119,000 ----------- ----------- Net increase (decrease) in cash and cash equivalents 1,738,000 1,028,000 Cash and cash equivalents at beginning of period 4,251,000 2,280,000 ----------- ----------- Cash and cash equivalents at end of period $ 5,989,000 $ 3,308,000 =========== =========== See accompanying notes. 5 6 CHEMTRAK INCORPORATED NOTES TO CONDENSED FINANCIAL STATEMENTS June 30, 1996 (unaudited) Note 1. Basis of Presentation The accompanying unaudited financial statements include all adjustments consisting of normal recurring adjustments which the Company's management believes to be necessary to fairly present the Company's financial position as of June 30, 1996, and the results of operations for the three and six months ended June 30, 1996 and 1995. The operating results of the interim periods presented are not necessarily indicative of the results for the full year. The accompanying financial statements should be read in conjunction with the financial statements for the year ended December 31, 1995, included in the ChemTrak Incorporated Annual Report on Form 10-K for the fiscal year ended December 31, 1995 (the "Form 10-K"), and the 1995 Annual Report to Stockholders (the "Annual Report"). The information set forth in the accompanying balance sheet as of December 31, 1995, has been derived from the audited balance sheet included in the above-referenced Form 10-K and Annual Report. Note 2. Net Loss Per Share Net loss per share is computed using the weighted number of shares outstanding. Common equivalent shares from stock options are excluded in the computation as their effect is antidilutive. Note 3. Inventories Inventories are stated at the lower of standard cost (which approximates actual costs on a first-in, first-out basis) or market. Inventories consisted of the following: June 30, 1996 December 31,1995 ------------- ---------------- Raw materials............. $153,000 $145,000 Work in process........... 64,000 41,000 Finished goods............ 483,000 248,000 -------- -------- Total..................... $700,000 $434,000 ======== ======== 6 7 CHEMTRAK INCORPORATED MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW In December 1995 ChemTrak regained the exclusive rights to market its AccuMeter Cholesterol Self-Test in the United States retail market. Previously sold as the Advanced Care Cholesterol Test by Direct Access Diagnostics ("DAD"), a Johnson & Johnson company, it has been relaunched under the trade name CholesTrak. CholesTrak is the first and only over-the-counter cholesterol test to be cleared by the U.S. Food and Drug Administration (the "FDA"). The Company's position in this market was solidified earlier in 1995 when the FDA cleared our High Density Lipoprotein, or so called "good cholesterol", test for professional use. On April 29, 1996, the Company announced it had signed a multi-year distribution agreement with Helena Laboratories (Canada) Ltd. for its CholesTrak home cholesterol test. This agreement will result in the launch of CholesTrak for the first time in Canada. Helena Laboratoris (Canada) has been marketing ColoCARE, a unique and patented home test for colorectal cancer and has created a new category in Canadian retail pharmacies. On July 2, 1996, the Company announced it had received marketing clearance from the U.S. FDA for its H. pylori test for use in physicians offices. In March 1995, ChemTrak entered into an exclusive distribution and supply agreement for its H. pylori test in the U.S. market with Astra Merck, Inc. a major pharmaceutical company. The Company has several products currently in development, some of which are based on the AccuMeter technology. Other product applications have only reached the laboratory feasibility stage. Factors that affect the Company's success include ChemTrak's ability to develop future products, its ability to manufacture its products, obtain regulatory clearance for marketing its products, and have its products marketed successfully, all on a timely basis. There can be no assurance that the Company's current product development efforts will be successfully completed, that products will be manufactured in the required commercial quantities, that timely required clearances will be obtained for the Company's future products on a timely basis, if at all, or that the Company's products will be marketed successfully. 7 8 As of June 30, 1996 the Company had an accumulated deficit of $32,111,000. Profitability is highly dependent upon numerous factors including, but not limited to, the Company's ability to provide product in sufficient, cost effective quantities and the ultimate success of its products in the U.S. over-the-counter market. Due to the uncertainty of these factors, it is difficult to reliably predict when such profitability may occur, if at all. The Company has historically experienced significant fluctuations in its operating results and anticipates that these fluctuations may continue. The market price of the shares of the Company's common stock, like those of other emerging medical technology companies, has been highly volatile. Various factors, including but not limited to fluctuations in the Company's operating results, technical and regulatory developments, general market and economic factors, may have a significant effect on the market price of the Company's common stock. RESULTS OF OPERATIONS NET REVENUES Total net revenues decreased to $606,000 for the three months ended June 30, 1996 from $758,000 for the three months ended June 30, 1995. Product sales increased to $581,000 in the three months ended June 30, 1996 from $238,000 in the three months ended June 30, 1995, due to the relaunch of the Company's AccuMeter Cholesterol Self-Test under the trade name CholesTrak. Funded research decreased to $25,000 for the three months ended June 30, 1996 from $520,000 for the three months ended June 30, 1995. The funded research of $520,000 for the second quarter of 1995 included a $200,000 milestone payment from DAD for completion of the third phase of a second generation total cholesterol test and a $250,000 milestone payment received from Astra Merck Inc. for work completed on the development stage test for detecting the presence of H. Pylori. For the six months ended June 30, 1996, net revenue was $1,612,000 as compared to $2,574,000 for the six months ended June 30, 1995. During the six months ended June 30, 1996, product sales were $1,437,000 as compared to $1,664,000 for the six months ended June 30, 1995. Funded research was $175,000 for the six months ended June 30, 1996, compared with $910,000 for the six months ended June 30, 1995. This decrease was due to reduced milestone payments from Astra Merck and DAD. COST OF PRODUCT SALES For the three months ended June 30, 1996, the cost of product sales increased to $824,000 from $640,000 for the three months ended June 30, 1995. The increase was due to the increase in product sales volume. The decrease in cost of product sales for the six months ended June 30, 1996 to $1,555,000 from $2,037,000 for the same period last year is primarily due to improved manufacturing effiencies. Product gross margin as a percentage of product sales increased to a negative 42% on the three months ending June 30, 1996 from a negative 169% for the same period in 1995. Product gross margin as a percentage of sales increased to a negative 8% for the six months ended June 30, 1996 from a negative 22% for the six months ended June 30, 1995. These increases were due to efforts made by the company to decrease manufacturing costs. 8 9 RESEARCH AND DEVELOPMENT Research and development expenses increased to $729,000 in the three months ended June 30, 1996 from $658,000 for the three months ended June 30, 1995. For the six months ended June 30, 1996, research and development expenses increased to $1,473,000 from $1,250,000 for the six months period ended June 30, 1995. These increases were primarily due to increased research spending associated with the Company's H. pylori test. MARKETING, GENERAL AND ADMINISTRATIVE Marketing, general and administrative expenses increased to $1,179,000 for the three months ended June 30, 1996 from $650,000 for the three months ended June 30, 1995. For the six months ended June 30, 1996, marketing, general and administration expenses were $2,273,000 as compared to $1,427,000 for the six months ended June 30, 1995. These increases were primarily due to selling and advertising expenses associated with the relaunch of the Company's CholesTrak total cholesterol test. INTEREST INCOME AND EXPENSE Interest income and expense decreased to $7,000 net expense in the three months ended June 30, 1996 from $75,000 income for the three months ended June 30, 1995, and decreased to $60,000 income for the six months ended June 30, 1996 from $158,000 income for the six months ended June 30, 1995. These decreases were due to reduced levels of short term investments and interest expense on convertible debentures that the Company issued during May 1996. LIQUIDITY AND CAPITAL RESOURCES From August 1985 through January 1992 the Company was financed through private placements of equity securities. In February 1992, the Company completed its initial public offering, raising approximately $23,500,000 net of issuance costs. In May 1996, the Company completed an issuance of convertible debentures, raising approximately $4,700,000 net of issuance costs. At June 30, 1996, the Company had approximately $7,478,000 in cash and short-term investments. During the three months ended June 30, 1996, the Company issued $5,000,000 of convertible debentures. Prior to this issuance, the Company had no long-term debt. The Company believes that its existing capital resources, together with internally generated funds, will be sufficient to meet its operating needs as well as its purchase requirements for property, plant and equipment for at least the next twelve months. 9 10 CHEMTRAK INCORPORATED PART II. OTHER INFORMATION Item 4. Submission of Matters to a Vote of Security Holders a) The Annual Meeting of Stockholders of ChemTrak Incorporated was held on May 16, 1996. b) David Rubinfien was elected to the board of directors to hold office until the 1999 Annual Meeting of Stockholders. Following is a list of persons whose term of office as directors of the Company continued after the meeting: Director Term Expires -------- ------------ Jerry B. Gin 1997 Malcolm Jozoff 1997 Gordon Russell 1998 Prithipal Singh, Ph.D. 1998 c) The matters voted upon at the meeting and the voting of the stockholders with respect thereto are as follows: The election of David Rubenfien as a director to hold office until the 1999 Annual Meeting of Stockholders: For: 8,279,369 Withheld: 73,729 Ratification of the selection of Ernst & Young LLP as independent public accountants of the Company for its fiscal year ending December 31, 1996: For: 8,312,891 Against:21,576 Abstain: 18,631 Broker Non-votes: 0 10 11 CHEMTRAK INCORPORATED PART II. OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-K Page -------------------------------- ---- a) Exhibits 11.1 Statement re: computation of income (loss) per share 14 b) Reports on Form 8-K A Current Report on Form 8-K (File No. 0-19749) dated May 13, 1996, announcing the closing of the convertible debenture transaction, was filed on June 6, 1996. 11 12 CHEMTRAK INCORPORATED SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Date: August 6, 1996 CHEMTRAK INCORPORATED ____________________________________________ Prithipal Singh, Ph.D. Chief Executive Officer and Chairman of the Board (Principal Executive Officer) ____________________________________________ Edward F. Covell President and Chief Operating Officer (Principal Financial Officer) ____________________________________________ Douglas W. Lange Principal Accounting Officer 12 13 CHEMTRAK INCORPORATED INDEX TO EXHIBITS EXHIBIT NO. DESCRIPTION ------- ----------- 11.1 Calculation of Earnings Per Share 27.1 Financial Data Schedule 18