• Revenues increased by 143% in 2006 compared to 2005
• Cash and cash equivalents of € 97.1 million as of December 31, 2006; further strengthened by additional € 33.6 million gross proceeds raised in Q1 2007
• Year highlighted by positive data from satraplatin Phase 3 registrational trial
- Highly statistically significant results for improvement in progression-free survival
Martinsried/Munich (Germany), Waltham, Mass. and Princeton, N.J., March 15, 2007 -
GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30; NASDAQ: GPCB) today reported financial results for the fourth quarter and fiscal year ended December 31, 2006.
Fiscal year 2006 compared to fiscal year 2005
Revenues increased 143% to € 22.7 million for the fiscal year ended December 31, 2006, compared to € 9.3 million for 2005. The increase in revenues is due to development funding received under the co-development and license agreement for satraplatin for Europe and certain other territories with Pharmion that was signed in December 2005. Research and development (R&D) expenses increased 16% to € 64.7 million for 2006 compared to € 55.7 million for 2005. This increase was mainly due to expenses related to satraplatin, such as expenses for clinical trials and the accrual of a milestone obligation to Spectrum Pharmaceuticals, Inc. in the amount of USD $6 million, which will become due upon the acceptance for filing of a New Drug Application (NDA) for satraplatin by the U.S. FDA and the acceptance of the Marketing Authorization Application (MAA) in Europe. In 2006, general and administrative (G&A) expenses increased 16% to € 23.8 million compared to € 20.6 million for 2005. Net loss for the fiscal year 2006 increased 3% to € (64.0) million compared to € (62.2) million for 2005. Basic and diluted loss per share was € (1.95) for 2006 compared to € (2.08) for 2005.
As of December 31, 2006, cash, cash equivalents, marketable securities and short-term investments totaled € 97.1 million (December 31, 2005: € 95.2 million), including € 1.5 million in restricted cash. Net cash burn for the fiscal year 2006 was € 38.5 million with net cash generated of € 12.5 million in the first quarter of 2006, net cash burn of € 16.1 million for the second quarter of 2006, net cash burn of € 14.6 million for the third quarter and of € 20.3 million for the fourth 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 consolidated statements of cash flows for the fiscal year ended December 31, 2006.
Quarter over quarter results: fourth quarter 2006 compared to third quarter 2006
Revenues for the fourth quarter of 2006 were € 5.1 million compared to € 6.6 million for the previous quarter. R&D expenses were € 15.6 million for the fourth quarter of 2006 compared to € 20.1 million for third quarter of 2006. G&A expenses for the second quarter were € 7.6 million compared to € 6.1 million for the previous quarter. The Company’s net loss decreased to € (17.2) million in the fourth quarter of 2006 compared to € (18.7) million for the previous quarter. Basic and diluted loss per share was € (0.50) for the fourth quarter of 2006 compared to € (0.57) for the previous quarter.
Comparison to previous year: fourth quarter 2006 compared to fourth quarter 2005
Revenues for the three months ended December 31, 2006 increased 79% to € 5.1 million compared to € 2.8 million for the same period in 2005. R&D expenses for the fourth quarter of 2006 were stable at € 15.6 million compared to € 15.6 million for the fourth quarter of 2005. G&A expenses for the fourth quarter of 2006 were € 7.6 million compared to € 5.5 million for the same quarter in 2005. Net loss for the fourth quarter of 2006 was stable at € (17.2) million compared to € (17.2) million for the fourth quarter of 2005. Basic and diluted loss per share was € (0.50) for the fourth quarter of 2006 compared to € (0.57) for the same period in 2005.
“Our revenues increased by 143% in 2006 compared to the previous year due to development funding received under our co-development and license agreement with Pharmion. This is the highest annual revenue figure in the history of GPC Biotech,” said Mirko Scherer, Ph.D., Senior Vice President and Chief Financial Officer.
“The year 2006 was the most significant year to date in the history of GPC Biotech, highlighted by the positive topline data from the satraplatin Phase 3 registrational trial in second-line hormone-refractory prostate cancer that we announced in the fall. To explore potential additional uses for satraplatin, we initiated a number of clinical trials exploring satraplatin in combination with a variety of anticancer treatments and in various cancer types. We are also moving forward with other anticancer programs in our pipeline. In December 2006, for example, we presented the first clinical data with our second product candidate, 1D09C3, a monoclonal antibody against lymphoid tumors,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer.
Dr. Seizinger continued: “The year 2007 promises to be another pivotal year for GPC Biotech as we progress through the regulatory process for satraplatin in the U.S. and – in cooperation with our partner Pharmion – in Europe. We expect that the U.S. FDA will reach a decision on our NDA filing for satraplatin during 2007.”
Highlights: fourth quarter 2006 and year-to-date 2007
• Private placement with institutional investors raising gross proceeds of € 33.6 million (~$43.7 million)
• Rolling submission of an NDA to the U.S. FDA for satraplatin completed
• Final progression-free survival (PFS) results for the satraplatin SPARC Phase 3 registrational trial in second-line chemotherapy for hormone-refractory prostate cancer presented at the ASCO Prostate Cancer Symposium in Orlando, Florida
• Satraplatin Expanded Rapid Access protocol (SPERA) launched in the U.S.
• Preliminary clinical data on anticancer monoclonal antibody 1D09C3 presented at the 48th Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida
Financial outlook 2007
Revenues: The Company expects revenues to remain stable in 2007 compared to 2006. The primary source of revenue for 2007 is expected to be from the Company’s co-development and licensing agreement with Pharmion.
Expenses: For 2007 the Company expects R&D expenses to be slightly higher than 2006.
The Company plans to continue to open more Phase 1 and 2 clinical trials with satraplatin in combination with other drugs and in other cancer types. In addition to the milestones to Spectrum Pharmaceuticals that the Company already accrued for in the third quarter of 2006, GPC Biotech is obligated to pay Spectrum an undisclosed milestone payment should satraplatin be granted marketing approval in the U.S. GPC Biotech is obligated to pay Spectrum a certain percentage of milestone payments GPC Biotech receives under any sublicense agreements, such as the agreement with Pharmion.
Selling, general and administrative expenses are expected to increase significantly during 2007 as the Company prepares for the launch of satraplatin.
Cash burn: For 2007, cash burn is expected to be higher than in 2006, mainly driven by significant outlays in preparation for the commercialization of satraplatin, including the ordering of commercial supplies.
Corporate calendar
Two dates in the corporate calendar have changed. The report on the financial results for the first quarter of 2007 will now be published on May 15, 2007 (previously scheduled for May 8). The Annual Shareholders Meeting will now be held on May 25, 2007 in Munich instead of June 6. All other 2007 financial reporting dates remain the same and are posted on the Company’s Web site at www.gpc-biotech.com.
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 March 15th at 14:00 CET/9:00 AM ET. The dial-in numbers for the call are as follows:
Participants from Europe:
0049 (0)69 9897 2633 or 0044 (0)20 7365 1832
Participants from the U.S.:
1-718-354-1171
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 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 has been completed. 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. 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: +1 781 890 9007 X267
Additional Media Contacts:
In Europe:
Maitland
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
David Schull
Phone: +1 212 845-4271
david.schull@eurorscg.com
Please click the following link to get the press release with financial tables:
Acrobat Reader Dokument, 1.6 MB
