Quarter highlighted by
• completion of NDA submission for satraplatin, now under priority review at the FDA
• presentation of important data from satraplatin SPARC Phase 3 trial at major medical conferences
Martinsried/Munich (Germany) and Princeton, N.J., May 15, 2007 - GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30; NASDAQ: GPCB) today reported financial results for the first quarter ended March 31, 2007.
First quarter 2007 compared to first quarter 2006
Revenues decreased 30% to € 3.8 million for the first quarter ended March 31, 2007, compared to € 5.4 million for the first quarter 2006. The decrease in revenues is mainly due to lower development funding received under the co-development and license agreement with Pharmion for satraplatin for Europe and certain other territories, which reflects the decrease in research and development (R&D) spending for the first quarter of 2007. R&D expenses decreased 10% to € 13.0 million for the first three months of 2007 compared to € 14.5 million for the same period in 2006. This decrease was mainly due to the maturation of the satraplatin SPARC Phase 3 registrational study. In the first quarter of 2007, general and administrative (G&A) expenses increased 150% to € 11.0 million compared to € 4.4 million for the first quarter of 2006. This increase is mainly due to expanded activities in marketing and sales and increased legal expenses. Net loss for the first quarter of 2007 increased 49% to € (19.2) million compared to € (12.9) million for the first quarter of 2006. Basic and diluted loss per share was € (0.54) for the first quarter of 2007 compared to € (0.41) for the same quarter in 2006.
As of March 31, 2007, cash, cash equivalents, marketable securities and short-term investments totaled € 112.8 million (December 31, 2006: € 97.1 million), including € 1.5 million in restricted cash. Net cash burn for the first quarter of 2007 was € 19.4 million. Net cash burn is derived by adding net cash used in operating activities and purchases of property, equipment and licenses. The figures used to calculate net cash burn are contained in the Company’s unaudited consolidated statements of cash flows for the first quarter ended March 31, 2007.
Quarter over quarter results: first quarter 2007 compared to fourth quarter 2006
Revenues for the first quarter of 2007 decreased 25% to € 3.8 million compared to € 5.1 million for the previous quarter. R&D expenses decreased 17% to € 13.0 million for the first quarter of 2007 compared to € 15.6 million for the fourth quarter of 2006. G&A expenses for the first quarter of 2007 increased 45% to € 11.0 million compared to € 7.6 million for the previous quarter. The Company’s net loss was € (19.2) million in the first quarter of 2007 compared to € (17.2) million for the previous quarter. Basic and diluted loss per share was € (0.54) for the first quarter of 2007 compared to € (0.51) for the previous quarter.
“For the fiscal year 2007, we confirm our guidance of stable revenues compared to the € 22.7 million we generated in 2006. We also reiterate our guidance for 2007 of a moderate increase in R&D expenses and a significant increase in G&A expenses due to the buildup of our commercial organization,” said Mirko Scherer, Ph.D., Senior Vice President and Chief Financial Officer. “With cash, cash equivalents and available for sale securities of € 112.8 million as of March 31, we are in a solid financial position to aggressively move forward with our plans for a possible launch of satraplatin later this year.”
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: “We have already had several key achievements in the first few months of 2007, including completion of the NDA submission for satraplatin and its acceptance for filing by the FDA. We are very pleased that FDA has granted the NDA submission priority review status and look forward to an action by the agency in August this year.”
Dr. Seizinger continued: “We are very busy preparing for the possible U.S. launch of satraplatin later this year. With the acceptance of the NDA filing and the assignment of priority review by the FDA, and with the senior management of our U.S. marketing and sales organization in place, we have begun to hire the field sales force. In addition, we continue to move forward satraplatin clinical trials in other oncology indications, as well as our other development and discovery programs.”
Key Achievements: Year-to-Date 2007
• Private placement with institutional investors raising net proceeds of € 32.6 million
• Rolling submission of an NDA for satraplatin completed and accepted for filing by the U.S. FDA
• NDA for satraplatin granted priority review status, setting target date for FDA action in August 2007
• Key progression-free survival (PFS) results as well as positive data on pain and PSA response rates from the satraplatin SPARC Phase 3 registrational trial in second-line chemotherapy for hormone-refractory prostate cancer presented at major international oncology and urology meetings
• Satraplatin Expanded Rapid Access protocol (SPERA) launched in the U.S.
Conference call scheduled
As previously announced, the Company has scheduled a conference call to which participants may listen via live webcast, accessible through the GPC Biotech Web site at www.gpc-biotech.com or via telephone. A replay will be available via the Web site following the live event. The call, which will be conducted in English, will be held on May 15 at 14:00 CET/8:00 AM ET.
The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0)69 9897 2631 or 0044 (0)20 7138 0813
Participants from the U.S.: 1-718-354-1359
Please dial in 10 minutes before the beginning of the meeting.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate satraplatin is currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany), and has a wholly owned U.S. subsidiary headquartered in Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at www.gpc-biotech.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. In particular, additional information relating to the safety, efficacy or tolerability of satraplatin may be discovered upon further analysis of data from the SPARC trial or analysis of additional data from other ongoing clinical trials for satraplatin. Furthermore, even if these results are confirmed upon full analysis of the trial, we cannot guarantee that satraplatin will be approved for marketing in a timely manner, if at all, by regulatory authorities nor that, if marketed, satraplatin will be a successful commercial product. We direct you to GPC Biotech’s Annual Report on Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech does not undertake any obligation to update these forward-looking statements, even if new information becomes available in the future.
The scientific information discussed in this press release related to satraplatin is investigative. Satraplatin has not yet been approved by the FDA in the U.S., the EMEA in Europe or any other regulatory authority and no conclusions can or should be drawn regarding its safety or effectiveness. Only the relevant regulatory authorities can determine whether satraplatin is safe and effective for the use(s) being investigated.
GPC Biotech AG
Martin Braendle
Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Russo Partners, LLC
David Schull
Phone: +1 212 845-4271
david.schull@russopartnersllc.com
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