Business Editors & Health/Medical Writers
RALEIGH, N.C.--(BUSINESS WIRE)--Oct. 29, 2002
PharmaNetics, Inc. (Nasdaq/NM:PHAR), a leader in theranostic management specializing in managing the delivery of therapeutics affecting coagulation, today announced results for the third quarter and nine months ended September 30, 2002.
John P. Funkhouser, president and chief executive officer of PharmaNetics, said, "The Company made exceptional progress during the third quarter of 2002. In late August, we received U.S. Food and Drug Administration clearance to market our ENOX(TM) Test. The ENOX Test, developed in collaboration with Aventis Pharmaceuticals Inc., is the first rapid, point-of-care test to be cleared in the U.S. to detect the anticoagulant effects of enoxaparin sodium. The Company has exclusively developed the ENOX Test specifically for enoxaparin among the low molecular weight heparin ("LMWH") class."
Mr. Funkhouser also said, "Following FDA clearance, we recently completed our ELECT (EvaLuating Enoxaparin Clotting Times) study, which evaluated the use of the ENOX Test in conjunction with enoxaparin in facilitating treatment of acute coronary syndrome patients who may transition to percutaneous coronary intervention (PCI). Preliminary results of the study, which was a joint collaboration between PharmaNetics and leading interventional cardiologists, will be announced at the American Heart Association Meeting in November 2002. We are now in the process of preparing a sales force trained specifically to promote the new test to cardiologists and intensivists and should be fully deployed by January 2003."
Revenues for the third quarter ended September 30, 2002, were $1.2 million compared with revenues of $1.2 million, in the same period in 2001. Specialty test card revenue decreased approximately $300,000 compared with the third quarter of 2001 when $500,000 in revenue was recognized related to an agreement with AstraZeneca. This decrease was offset by increased analyzer sales to the Company's distributor, Bayer Diagnostics. Operating expenses totaled $2.6 million and were slightly higher than in the prior year due to increased research and development expenses, principally related to the Company's Enox Test. After other income and the preferred stock dividend, the resulting net loss attributable to common stockholders for the third quarter of 2002 was $2.3 million, or $0.24 per share, compared with $2.2 million, or $0.23 per share, for the same period in the prior year.
During the 2002 third quarter, the Company received a milestone payment from Aventis upon the FDA clearance of the Company's Enox Test. An additional milestone payment is due the Company upon product launch.
Revenues for the nine months ended September 30, 2002, were $2.9 million compared with revenues of $3.4 million in the same period in 2001. The first nine months of 2001 included $1 million of revenue related to the AstraZeneca agreement, but this decrease was partially offset by increased sales of analyzers and controls in 2002 compared with 2001. After higher research and development expenses and slightly higher other income, the net loss for the 2002 nine-month period was $6.8 million compared with $6.1 million in the prior-year period. Net loss attributable to common stockholders for the nine months ended September 30, 2002, was $7.1 million, or $0.74 per share, compared with $6.5 million, or $0.75 per share, for the same period in the prior year.
Mr. Funkhouser added, "We are very excited and optimistic now that the FDA has cleared our ENOX Test, and we can begin commercialization of this important product. The FDA's action clears the way for us to begin the next phase of our growth, and we are very well positioned to do so. In preparation for this milestone event, we had invested over $70 million, put in place an experienced and motivated staff, and built a state-of-the-art manufacturing facility. We are confident of success because we believe in the ENOX Test's ability to empower physicians to provide better care for their patients. It is extremely rewarding to note that our success as a company is directly related to our ability to contribute to the health and well being of patients around the world. Clearly, this is a strong incentive for us to continue our efforts to obtain FDA approval for additional tests as new anticoagulants come to market."
Subsequent to the close of the third quarter, the Company announced the signing of an agreement with The Medicines Company (TMC) (Nasdaq/NM:MDCO), under which TMC will purchase Ecarin Clotting Time (ECT) tests for the rapid evaluation of the anticoagulant effects of Angiomax(R) (bivalirudin), TMC's direct thrombin inhibitor. The terms of the agreement also provide that TMC will furnish data from their clinical trials of Angiomax in Coronary Artery Bypass Graft (CABG) surgery for PharmaNetics to pursue FDA clearance to market the test cards for use with Angiomax. There are over 500,000 CABG procedures performed each year in the United States, and PharmaNetics estimates that the potential market for the ECT in this indication could exceed 1.0 million tests annually. Bivalirudin is a part of the Company's efforts to develop tests for thrombin inhibitors. In addition to testing for Bivalirudin, the Company can also rapidly manage Melagatran, Refludan, PEG-Hirudin and Argatroban.
PharmaNetics, Inc., a leading biotech company, conceived the term "theranostics," defining an emerging new field of medicine that enables physicians to monitor the effect of antithrombotic agents in patients being treated for angina, myocardial infarction (heart attack), stroke, and pulmonary and arterial emboli. The Company develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. PharmaNetics develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System for its principal target market of managing powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as for monitoring routine anticoagulants.
A listen-only simulcast and 48-hour replay of PharmaNetics' third quarter conference call will be available online at the Company's website at www.pharmanetics.com or at www.companyboardroom.com on October 29, 2002, beginning at 11:00 a.m. Eastern time.
This press release contains forward-looking statements regarding future events and the future performance of PharmaNetics that involve risks and uncertainties such as risks related to market acceptance, clinical trials and dependence on third-party distributors and collaborative partners that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning these and other of the factors that could cause results to differ materially from those in the forward-looking statements is contained in the Company's filings with the Securities and Exchange Commission, including Form 10-K, Form 10-Q and Form 8-K reports.
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