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BEAVERTON, Ore., Aug. 1 /PRNewswire/ -- Epitope, Inc. (AMEX: EPT) today reported operating results for the third quarter and first nine months of its fiscal year. The company reported a profit of $3.5 million ($ .25 per share, fully diluted) for the quarter. The current quarter results include $5.2 million for a license fee and related accrued interest from the company's marketing partner, SmithKline Beecham (SB). The fee was triggered by the April decision of the Food and Drug Administration to approve the company's application for extension of the expiration date on the company's oral specimen collection device from nine months to two years from date of manufacture. During the quarter, the company also received FDA approval of its OraSure(R) HIV confirmatory test which permits HIV diagnosis using an oral specimen without a follow-up blood test. "The FDA actions this quarter mean that our oral specimen collection product line is stronger than ever. With the approval of extended dating for the device plus approval of the OraSure Western blot confirmatory test, we now can offer a complete and attractive alternative which eliminates the use of blood samples for HIV testing," said Adolph J. Ferro, president and chief executive officer. "We closed the quarter with over $25 million in cash and $1.7 million of orders for delivery of products in the final quarter of fiscal 1996. We are making excellent progress toward achieving our goal of becoming a profitable enterprise." Ferro noted that sales of the oral specimen collection device to date have been primarily for insurance risk assessment testing. Next week, SmithKline Beecham will launch the product in health care professional markets. Sales of medical products were $1.1 million for the current quarter, an increase of 22% as compared to the third quarter of fiscal 1995. The company's oral specimen collection device accounted for revenues of $695,000, up from $389,000 for the previous year's third quarter. For the nine-month period of the current fiscal year, oral specimen collection device sales were $1.8 million as compared to $718,000 for the first nine months of fiscal 1995. Operating losses were $1.9 million and $5.8 million for the quarter and nine months ended June 30, 1996, respectively, as compared with the significantly higher levels of $4.5 million and $13.9 million for the comparable 1995 periods. The company divested several loss operations in 1995 and implemented a restructuring program that continues to produce cost savings. The cost reductions were augmented by higher sales volumes and increased gross margins for the company's medical products. The Following Recap Highlights Milestones Achieved in Recent Months: Dating Extended for Oral Specimen Collection Device In April 1996, the FDA approved the Company's application to extend the expiration date on the Company's oral specimen device from nine months to two years. As noted above, the approval resulted in realization of a license fee of $5 million plus interest income of approximately $200,000 in its operating results for the quarter ending June 30, 1996. HIV Confirmatory Test Approved for Oral Specimens In June 1996, the FDA approved an application seeking permission to market its Western blot confirmatory test for use in HIV-1 testing on specimens collected by the company's oral specimen collection device. This action eliminates the need to confirm HIV screening results by means of a blood sample. Both screening and confirmation tests may now be performed on a single oral specimen. SmithKline Beecham Plans Launch of the OraSure(R) Oral Fluid Specimen Collection Device to Professional Markets Following FDA approval of the OraSure(R) HIV confirmatory test, SB announced to the trade that it will commence marketing the OraSure oral specimen device to healthcare professionals for HIV testing in the U.S. In preparation for the August 5th launch, SB introduced the product to attendees at the recent International AIDS Conference in Vancouver, British Columbia. SB plans to utilize the services of over 3,000 sales representatives to market the product. Vector Securities Selected to Advise Company on Strategic Alliances and Financing Alternatives In July 1996, the company engaged the services of Vector Securities International, a prominent investment banking firm that specializes in advising life sciences and healthcare companies. Vector will provide advice and assistance, with respect to developing strategic alliances and exploring financing alternatives with the objective of enhancing shareholder value. A tabulation of results follows: (in thousands, except per share data): Operating Highlights: Three months ended Nine months ended 6/3 ? 6/30/95 6/30/96 6/30/95 Revenues $ 1,272 $ 1,569 $ 4,053 $ 4,378 Net profit (loss) 3,500 (4,148) 30 (13,283) Net profit (loss) per share, primary and fully diluted $ .25 $ (.34) $ - $ (1.14) Average shares outstanding, primary and fully diluted 13,840 12,339 13,413 11,697 Selected Balance Sheet Data: 6/30/96 6/30/95 Cash and marketable securities $25,230 $23,563 Working capital 26,889 24,217 Convertible notes 3,620 3,620 Shareholders' equity 28,525 26,771 Epitope, Inc. is a biotechnology company that develops and markets medical diagnostic products and, through its agricultural unit, superior new plant varieties. This release includes forward-looking statements which are subject to factors described in Epitope's Annual Report on Form 10-K for the year ended September 30, 1995, and other documents filed with the Securities and Exchange Commission. These factors include unexpected interruption of supply or manufacturing operations, changes in its marketing partners' strategy or emphasis, development of competing products, market acceptance of oral testing, changes in insurance industry practices, unexpected delays in obtaining state approvals, changes in federal or state law or regulations, and changes in Epitope's business strategy. Source: EPITOPE Inc. Content of this page is copyright and reprinted here for educational and historical information. |
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