GPC Biotech Reports Financial Results for Third Quarter and First Nine Months of 2006
• Revenues more than tripled in third quarter 2006 compared to the same period in 2005
• Revenue guidance increased for the full year 2006; now expected to exceed € 22 million
• Cash and equivalents € 114 million (~$145 million) as of September 30, 2006
Martinsried/Munich (Germany), Waltham, Mass. and Princeton, N.J., November 9, 2006 - GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30; NASDAQ: GPCB) today reported financial results for the third quarter and first nine months ended September 30, 2006.
Quarter over quarter results: third quarter 2006 compared to second quarter 2006
Revenues for the third quarter of 2006 were € 6.6 million compared to € 5.6 million for the previous quarter. Research and development (R&D) expenses were € 20.1 million for the third quarter of 2006 compared to €14.5 million for second quarter of 2006. General and administrative (G&A) expenses for the second quarter were € 6.1 million compared to € 5.8 million for the previous quarter. The Company’s net loss increased to € (18.7) million in the third quarter of 2006, compared to € (15.2) million for the previous quarter. Basic and diluted loss per share was € (0.57) for the third quarter of 2006 compared to € (0.46) for the previous quarter.
Comparison to previous year: third quarter 2006 compared to third quarter 2005
Revenues for the three months ended September 30, 2006 increased 214% to € 6.6 million compared to € 2.1 million for the same period in 2005. The increase in revenues is due to the co-development and license agreement for satraplatin for Europe and certain other territories with Pharmion that was signed in December 2005. R&D expenses increased 36% for the third quarter of 2006 to € 20.1 million compared to € 14.8 million for the same period in 2005. This increase was mainly due to the accrual of a milestone obligation to Spectrum Pharmaceuticals, Inc. in the amount of € 4.8 million, which will become due upon the acceptance for filing of a New Drug Application for satraplatin by the U.S. FDA and the acceptance of the Marketing Authorization Application (MAA) in Europe. G&A expenses for the third quarter of 2006 increased 32% to € 6.1 million compared to € 4.6 million for the same quarter in 2005. G&A expenses for the third quarters of both 2006 and 2005 included a non-cash charge related to a contractual loss on a sublease. This charge was € 0.9 million for the third quarter of 2006 compared to € 0.1 million for the same period in 2005. Net loss for the third quarter of 2006 increased 13% to € (18.7) million compared to € (16.5) million for the third quarter of 2005. Basic and diluted loss per share was € (0.57) for the third quarter of 2006 compared to € (0.55) for the same period in 2005.
First nine months of 2006 compared to first nine months of 2005
Revenues increased 171% to € 17.6 million for the nine months ended September 30, 2006, compared to € 6.5 million for the same period in 2005. Research and development (R&D) expenses increased 23% to
€ 49.1 million for the first nine months of 2006 compared to € 39.9 million for the same period in 2005. In the first nine months of 2006, general and administrative (G&A) expenses increased 7% to € 16.2 million compared to € 15.1 million for the first nine months of 2005. Net loss for the first nine months of 2006 increased 4% to € (46.8) million compared to € (44.9) million for the first nine months of 2005. Basic and diluted loss per share was € (1.44) for the first nine months of 2006 compared to € (1.51) for the same period in 2005.
As of September 30, 2006, cash, cash equivalents, marketable securities and short-term investments totaled € 113.9 million (December 31, 2005: € 95.2 million), including € 1.6 million in restricted cash. Net cash burn for the first nine months of 2006 was € 18.2 million with net cash generated of € 12.8 million in the first quarter of 2006, net cash burn of € 16.1 million for the second quarter of 2006 and net cash burn of € 14.6 million for the third quarter of 2006. Net cash burn/generated is derived by adding net cash provided by (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 nine-month period ended September 30, 2006.
“Our revenues more than tripled in the third quarter of 2006 compared to the same period in 2005 due to our co-development and license agreement with Pharmion,” said Mirko Scherer, Ph.D., Senior Vice President and Chief Financial Officer. “With the revenue that we have already recognized this year under the terms of this deal, we are able to increase our guidance for the full year 2006. Originally, we expected to approximately double the 2005 revenue amount of € 9.3 million to just under € 19 million. We now expect to book revenues of more than € 22 million for 2006.”
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: “In the third quarter of 2006, we achieved a landmark event in the corporate history of GPC Biotech, with the announcement of positive results on progression-free survival from our Phase 3 registrational trial with our lead anticancer drug candidate satraplatin. These results will form the basis of our NDA filing, which we expect to submit to the FDA in the next six to twelve weeks, with the goal of filing by the end of this year. They will also serve as the basis for our partner Pharmion to move forward with the MAA filing in Europe in the first half of 2007. We are also moving forward aggressively to further build our marketing and sales infrastructure in the U.S. for the commercialization of satraplatin.”
Highlights from the third quarter of 2006 and later
• Positive results announced from satraplatin pivotal Phase 3 SPARC trial
- Highly statistically significant results seen for progression-free survival endpoint (p<0.00001)
- 40% reduction in risk of disease progression seen with satraplatin compared to control
• New clinical trials opened with satraplatin
- Phase 2 randomized study evaluating satraplatin in combination with Tarceva® (erlotinib) in patients with advanced non-small cell lung cancer
- Phase 1/2 study evaluating satraplatin in combination with radiation therapy and Xeloda® (capecitabine) in patients with rectal cancer
- Phase 1 study evaluating satraplatin in combination with Gemzar® (gemcitabine) in patients with advanced solid tumors
• In vitro data presented evaluating satraplatin in combination with Tarceva at the EORTC-NCI-AACR meeting on molecular targets and cancer therapeutics
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 November 9th at 14:00 CET/8:00 AM EST. The dial-in numbers for the call are as follows:
European participants: 0049 (0)69 5007 1307 or 0044 (0)20 7806 1955
U.S. participants: 1-718-354-1388
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 an oral platinum-based compound that has shown highly statistically significant results for progression-free survival in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer. The U.S. FDA has granted fast track designation to satraplatin for this indication, and the rolling NDA submission process for this compound is underway. 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 its wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and 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, including summary statements relating to topline results of the SPARC trial and summary statements relating to the potential efficacy and safety profile of satraplatin. 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, there can be no guarantee that topline results from the satraplatin Phase 3 clinical trial in second-line hormone refractor prostate cancer will be confirmed upon full analysis of the results of the trial and 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 topline 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 preliminary and 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.
Gemzar® (gemcitabine) is a registered trademark of Eli Lilly and Company.
Tarceva® (erlotinib) is a registered trademark of OSI Pharmaceuticals, Inc.
Xeloda® (capecitabine) is a registered trademark of Hoffmann-La Roche AG.
- Contact Information
- Laurie Doyle
- Director, Investor Relations & Corporate Communications
- GPC Biotech AG
- Contact via E-mail
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