EPIX Pharmaceuticals Announces Third Quarter Results.Successful Completion of Predix Merger; Initiated Amgen Collaboration; Continued Progress in Clinical Development of Four Novel Therapeutic Product Candidates LEXINGTON, Mass. -- EPIX EPIX Emergency Preparedness Information Exchange EPIX Enhanced Performance unIX EPIX European Property Stock Index Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :EPIX) today reported financial results for the third quarter and nine months ended September 30, 2006. "We have made significant strategic progress during the third quarter. The completion of the merger between EPIX and Predix has created a biopharmaceutical organization with a proprietary pipeline focused on large markets including depression, Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. , obesity and cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease ," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals. "In August, we announced a major collaboration with Amgen for the development of S1P1 modulators. The goal of this collaboration is to leverage EPIX's discovery capabilities and Amgen's expertise in autoimmune research to develop new therapies that will more effectively treat a variety of autoimmune disorders Autoimmune Disorders Definition Autoimmune disorders are conditions in which a person's immune system attacks the body's own cells, causing tissue destruction. and create long-term value for shareholders. We believe this agreement is illustrative of the type of collaborative opportunities that may be available to us through our ongoing drug discovery and development activities." Financial Results EPIX completed its merger with Predix Pharmaceuticals Holdings, Inc. in August 2006. The merger was primarily a stock transaction valued at approximately $125 million, including the assumption of net debt at closing. The purchase price includes a milestone payment of $35 million based on Predix's strategic collaboration with Amgen Inc., which was a strategic milestone under the merger agreement. Pursuant to the terms of the merger agreement, $20 million of the milestone was paid in cash in October 29, 2006. The remaining $15 million of the milestone payment will be paid in shares of EPIX common stock on October 29, 2007, except to the extent that such shares would exceed 49.99% of outstanding shares immediately after such milestone payment when combined with all shares of EPIX common stock issued in the merger and issuable upon exercise of all Predix options and warrants, which were assumed in the merger. In addition, during the 2006 third quarter and in connection with the merger, EPIX affected a 1-for-1.5 reverse stock split of its outstanding common stock and all outstanding Predix options and warrants were assumed by EPIX. All share and per share information has been restated to reflect the reverse stock split. The financial results for the three and nine month periods ended September 30, 2006 include operating results for Predix from the closing date of the merger, August 16, 2006. Total revenues in the third quarter of 2006 were $1.3 million, compared to $2.3 million in the third quarter of 2005. Total revenues during the nine month period were $4.4 million, compared to $5.4 million during the comparable period last year. The GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). net loss in the third quarter of 2006 was $133.1 million, or $6.00 per share, and in the nine month period in 2006 was $140.8 million, or $7.92 per share. The net loss for both 2006 periods compares with a GAAP net loss in the third quarter of 2005 of $5.7 million, or $0.36 per share, and a GAAP net loss in the nine months in 2005 of $19.0 million, or $1.23 per share. Excluding a non-recurring charge of $123.5 million recorded for in process research and development relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the merger, EPIX reported a non-GAAP net loss in the third quarter of 2006 of $9.6 million, or $0.43 per share, and a non-GAAP net loss in the nine-month period in 2006 of $17.3 million, or $0.97 per share. Research and development expenses totaled $8.2 million in the third quarter of 2006, compared to $5.5 million in the third quarter of 2005. The increase in research and development expenses is primarily attributable to clinical trial costs for the four clinical programs obtained through the merger with Predix. General and administrative expense was $2.9 million in the third quarter of 2006 compared to $2.6 million in the third quarter of 2005. The increase in general and administrative expense is due primarily to the additional personnel and operating costs operating costs npl → gastos mpl operacionales associated with the increase in headcount as a result of the merger. GAAP operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the third quarter of 2006 were $134.8 million as compared to $8.1 million for the third quarter of 2005. Excluding the non-recurring charge of $123.5 million for in process research and development, total non-GAAP operating expenses for the third quarter of 2006 were $11.3 million. As of September 30, 2006, EPIX had cash, cash equivalents and short-term investments of $113.1 million compared to $124.7 million on December 31, 2005. EPIX had $100.0 million of convertible debt outstanding at September 30, 2006 and December 31, 2005. Approximately 29.2 million shares of common stock were outstanding at September 30, 2006. EPIX Recent Highlights and Accomplishments * Major Pharmaceutical Collaboration. EPIX announced a significant collaboration with Amgen for the development of existing EPIX preclinical compounds and new S1P1 modulators. Amgen will be responsible for clinical development and commercialization of the product candidate(s). Under this agreement, EPIX received a non-refundable upfront payment of $20 million. Additionally, if certain clinical, regulatory and sales milestones are achieved, EPIX can earn up to an additional $287.5 million in milestone payments. Under the agreement, EPIX will have the opportunity to receive royalties on future sales of products resulting from this collaboration and will have the option to promote a product resulting from this collaboration to specialty physicians in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. for a selected indication. * New Focus on Depression. Top-line results from the 2006 Phase 3 trial of PRX-00023, a novel long-acting 5-HT1A agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. , showed that while PRX-00023 did not achieve a statistically significant improvement from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) compared to placebo, the primary endpoint in this trial, the data from this trial did show a statistically significant improvement from baseline in the Montgomery Asberg Depression Rating Scale (MADRS MADRS Montgomery-Asberg Depression Rating Scale ) compared to placebo. The MADRS, which measures symptoms of depression, was a pre-specified secondary endpoint in this trial. Based on further analysis of the data, EPIX is refocusing Noun 1. refocusing - focusing again focalisation, focalization, focusing - the act of bringing into focus the clinical development program for PRX-00023 on depression and expects to initiate a Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. in patients with major depressive disorder Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder in the first half of 2007. * Progress in PH Associated with COPD COPD chronic obstructive pulmonary disease. COPD abbr. chronic obstructive pulmonary disease Chronic obstructive pulmonary disease (COPD) . In August, 2006, EPIX initiated a Phase 2 clinical trial to evaluate the short-term efficacy and safety of PRX-08066, a serotonin serotonin (sĕr'ətō`nĭn), organic compound that was first recognized as a powerful vasoconstrictor occurring in blood serum. It was partially purified, crystallized, and named in 1948, and its structure was deduced a year later. 5-HT2B antagonist antagonist /an·tag·o·nist/ (an-tag´o-nist) 1. a substance that tends to nullify the action of another, as a drug that binds to a cell receptor without eliciting a biological response, blocking binding of substances that could , in patients with pulmonary hypertension Pulmonary Hypertension Definition Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right (PH) associated with chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. (COPD). There are currently no approved drugs to treat PH associated with COPD. * Vasovist Appeal Denied by U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ; Approved for Marketing in Australia and Canada. During the third quarter, EPIX received a letter from the U.S. Food and Drug Administration (FDA) denying EPIX's formal appeal to approve its novel blood-pool imaging agent Vasovist and turning down EPIX's request for an Advisory Committee. EPIX is continuing to evaluate next steps for Vasovist in the United States. In August, Vasovist was approved for marketing in Australia, and approved in November for marketing in Canada. Vasovist has also been approved by the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. for marketing in all 25 member states of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , and in Norway, Iceland and Switzerland. Dr. Kauffman further commented, "the accomplishments of the third quarter position EPIX for significant, potential value-creating milestones in the months ahead. We are looking forward to negotiating a collaboration for EP2104R, as well as continuing our ongoing strategic partnering discussions regarding certain of our therapeutic product candidates. We believe that we have a strong financial position and intend to continue to advance the clinical development of our proprietary therapeutic product candidates, including our novel 5-HT6 antagonist PRX-07034 - our potential treatment for obesity and cognitive impairment associated with Alzheimer's disease and schizophrenia - which we recently announced entered a Phase 1 multiple ascending dose clinical trial in otherwise healthy obese patients." Upcoming Presentations The full data set from the Phase 2a clinical trial of EP-2104R, EPIX's novel fibrin-imaging agent, will be presented in November at the Radiological Society of North America The Radiological Society of North America (RSNA), founded in 1915, has the purpose to "promote and develop the highest standards of radiology and related sciences through education and research". (RSNA RSNA Radiological Society of North America, Inc. RSNA Robust Security Network Association ) Annual Meeting 2006 in Chicago, IL: * Oral Presentation at RSNA: November 29, 2006 at 11:30 a.m. Central Standard Time
-- Session: Molecular Imaging (Imaging Agents), The Use of a
Fibrin-binding Magnetic Resonance Imaging Agent (EP-2104R)
to Visualize Thrombi in the Venous and Arterial Vasculature,
Presented By Josef Vymazal, M.D., from the Hospital Na
Homolce, Czech Republic.
About EPIX EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products through the use of proprietary technology to better diagnose, treat and manage patients. The company has a blood-pool imaging agent (Vasovist[TM]) approved and marketed in Europe and approved in Canada, Australia and Switzerland, and five internally-discovered therapeutic and imaging drug candidates currently in clinical trials targeting conditions such as depression, Alzheimer's disease, cardiovascular disease and obesity. These drug candidates include EP-2104R, a novel thrombus thrombus /throm·bus/ (throm´bus) pl. throm´bi a stationary blood clot along the wall of a blood vessel, frequently causing vascular obstruction. imaging agent which has completed a Phase 2a trial, PRX-08066 in Phase 2 clinical development for pulmonary hypertension associated with chronic obstructive pulmonary disease, and PRX-03140, which has completed a Phase 1b clinical trial in Alzheimer's patients. EPIX also has collaborations with leading organizations, including Amgen, Cystic Fibrosis Foundation The Cystic Fibrosis Foundation (CFF) is a non-profit organization in the United States established to provide the means to cure and control cystic fibrosis. The Foundation provides information about cystic fibrosis (CF) and finances CF research that aims to improve the Therapeutics, and Schering AG (Germany). For more information about EPIX, please visit the company's website at www.epixpharma.com. Non-GAAP Financial Information EPIX provides non-GAAP operating expenses, net loss and net loss per share data as additional information for its operating results. These measures are not in accordance with, or an alternative for, generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting and may be different from non-GAAP measures used by other companies. EPIX's management believes these non-GAAP measures are useful to investors because this supplemental information facilitates comparisons to prior periods. Management uses these non-GAAP measures to evaluate its financial results, develop budgets and manage expenditures. Investors are encouraged to review the reconciliations of these non-GAAP financial measures to the comparable GAAP results, which are attached to this press release. Forward-Looking Statements This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, that are based on current expectations of management. These statements relate to, among other things, our expectations regarding our regulatory and business strategies and the progress of our clinical development program , the timing and results of clinical trials involving our drug candidates, strategic collaborations and management's plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials, any failure to comply with regulations relating to our products and product candidates, including FDA requirements; failure to obtain the financial resources to complete development of product candidates; the risk that the FDA may interpret the results of our studies differently than we have; our inability to further identify, develop and achieve commercial success for new products and technologies; competing products may be more successful; our inability to interest potential partners in our technologies and products, particularly EP-2104R; our inability to achieve commercial success for our products and technologies; the possibility of delays in the research and development necessary to select drug development candidates; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; our inability to successfully in-license products and/or technologies; our inability to successfully defend against litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , including any appeal or re-filing of the shareholder class action lawsuit class action lawsuit A lawsuit in which one party or a limited number of parties sue on behalf of a larger group to which the parties belong. For example, investors may bring a class action lawsuit against a brokerage firm that has actively promoted a tax ; our inability to protect our intellectual property and the cost of enforcing or defending our intellectual property rights; the risk that we will not successfully integrate Predix's business; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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