IRVINE, Calif., March 14 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today reported results for the fiscal year ended December 31, 2006.
Fiscal Year 2006 Results
For the fiscal year ended December 31, 2006, Spectrum Pharmaceuticals recorded a net loss of approximately $23.3 million, or approximately ($0.96) per share, compared to a net loss of approximately $18.6 million, or approximately ($1.06) per share, in the fiscal year ended December 31, 2005. Fiscal 2006 revenues were approximately $5.7 million compared to $577 thousand in fiscal 2005.
The net cash used in operations during the fiscal year ended December 31, 2006 was approximately $13.5 million. Notably, cash used in operations in the fourth quarter of 2006 was approximately $250 thousand as a result of the revenue received in the fourth quarter. As of December 31, 2006, the Company had cash, cash equivalents and marketable securities of approximately $50.7 million.
“We continued to increase value for our shareholders and visibility for our company in 2006 through the achievement of several important milestones. We saw progress with our late-stage clinical programs as we announced positive pivotal Phase 3 data with satraplatin in hormone refractory prostate cancer and positive Phase 2 data with ozarelix in BPH,” stated Rajesh C. Shrotriya, M.D. Chairman, President and CEO of Spectrum Pharmaceuticals. “We are looking forward to maintaining momentum throughout 2007 and beyond as we expect to initiate Phase 3 clinical trials with our proprietary drugs EOquin(R) and ozarelix. We also expect to receive milestone payments upon the acceptance and approval of the satraplatin NDA and look forward to receiving royalties on satraplatin following its launch in the U.S., if approved by the FDA, later this year or soon thereafter.”
Recent Highlights * Approximately $50.7 Million In Cash and Equivalents at Year End * Sumatriptan Paragraph 4 Challenge and Generics - ANDA for sumatriptan succinate injection approved tentatively by FDA - Received $5 million payment from Par Pharmaceutical Companies, Inc. - Settled patent litigation with GlaxoSmithKline, authorized generic launch set for 2H08 - Received $1 million from JBCPL, our partner in India in consideration for modification of supply agreement and issuance of 120,000 shares of common stock * Satraplatin - NDA Filed on February 15, 2007 - Reported highly statistically significant results in the pivotal phase 3 trial of satraplatin as a second-line treatment for patients suffering from hormone refractory prostate cancer (HRPC) * Ozarelix - Reported highly statistically significant Phase 2 results for ozarelix, in patients suffering from benign prostate hypertrophy (BPH) - Partner AEterna Zentaris entered into an agreement with Nippon Kayaku for the development and marketing of ozarelix for all potential oncology indications in Japan * EOquin - Reached Special Protocol Assessment agreement with FDA On Phase 3 Trials Key Upcoming Milestones * Satraplatin - U.S. FDA approval and commercial launch - European filing in 2007 with approval and commercial launch in 2008 * Sumatriptan Injection - Commercial launch of authorized generic in 2008 * EOquin - Commence pivotal Phase 3 trial for non-invasive bladder cancer in 2Q07 * Ozarelix - Complete Phase 2b in BPH in 2H07 - Commence pivotal Phase 3 study in BPH in 2H07 or soon thereafter * LFA (Levofolinic acid) - Submit to the FDA Response on CMC Questions - U.S. FDA approval in 2H07 - Commence combination study with capecitabine in 2H07. Conference Call
Spectrum Pharmaceuticals will host a conference call to discuss these financial results and pipeline update on:
Wednesday, March 14, 2007 @ 11:00 a.m. Eastern/8:00 a.m. Pacific Domestic: 866-510-0676 International: 617-597-5361 Passkey: 75514452 Webcast and replays: www.spectrumpharm.com Audio replays will be available through March 21, 2007. Domestic: 888-286-8010 International: 617-801-6888 Passkey: 93383097 About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is opportunistically acquiring and advancing a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statement -- This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum’s ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company’s promising pipeline, our team’s ability to identify promising drugs and move these drugs through development and toward commercialization, maintaining momentum throughout 2007 and beyond as we initiate Phase 3 clinical trials with our proprietary drugs EOquin and ozarelix, that we will receive milestone payments upon the acceptance and approval of the satraplatin NDA and royalties on satraplatin following its launch in the U.S., for satraplatin, U.S. FDA approval and commercial launch and European filing in 2007 with approval and commercial launch in 2008, commercial launch in 2008 of sumatriptan injection, commencement of pivotal Phase 3 trials for EOquin for non-invasive bladder cancer in 2Q07, for Ozarelix, complete Phase 2b in BPH in 2H 2007 and commence pivotal Phase 3 study in BPH in 2H 2007 or soon thereafter, for LFA, submit to the FDA Response on CMC Questions, U.S. FDA approval in the second half of 2007 and commencement of a combination study with capecitabine in 2H07 and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
COMPANY CONTACTS MEDIA CONTACT Russell Skibsted Susan Neath SVP & Chief Business Officer Porter Novelli Life Sciences 619-849-6000 Paul Arndt Manager, Investor Relations 949-788-6700 SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES (In thousands, except Share and per share data) Summary Condensed Consolidated Statement of Operations (Unaudited) Years Ended December 31, 2006 2005 2004 Revenues $5,673 $577 $258 Operating expenses: Cost of product sold 97 397 123 Research and development 17,872 12,600 6,954 General and administrative 6,330 6,490 5,096 Stock-based charges 7,267 1,012 885 Total operating expenses 31,566 20,499 13,058 Loss from operations (25,893) (19,922) (12,800) Other income, net 2,606 1,279 518 Net loss before minority interest in consolidated subsidiary (23,287) (18,643) (12,282) Minority interest in net loss of consolidated subsidiary 3 1 (4) Net loss $(23,284) $(18,642) $(12,286) Basic and diluted net loss per share $(0.96) $(1.06) $(0.98) Basic and diluted weighted average common shares outstanding 24,311,306 17,659,602 12,674,506 Supplemental Information Stock-based charges - Components: Research and development $5,856 $883 $634 General and administrative 1,411 129 251 Total stock based charges 7,267 1,012 885 Summary Condensed Consolidated Balance Sheets (Unaudited) December 31, December 31, 2006 2005 Cash, cash equivalents and marketable securities $50,697 $63,667 Accounts Receivable, net 1,150 287 Other current assets 440 431 Total current assets 52,287 64,385 Property and equipment, net and other assets 830 690 Total assets $53,117 $65,075 Total liabilities $7,268 $4,069 Minority Interest 20 23 Stockholders’ equity 45,829 60,983 Total liabilities and stockholders’ equity $53,117 $65,075
Spectrum Pharmaceuticals, Inc.
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul Arndt,Manager, Investor Relations, +1-949-788-6700, both of SpectrumPharmaceuticals, Inc.; or Media, Susan Neath of Porter Novelli LifeSciences, +1-619-849-6000, for Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
