GPC Biotech Reports Financial Results for First Quarter of 2006
• Revenues increased 187% in first quarter 2006 compared to the same period in 2005
• Cash and equivalents increased 51% from year end 2005 to € 144.1 million as of March 31, 2006
Martinsried/Munich (Germany), and Waltham, Mass. and Princeton, N.J., May 4, 2006 – GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today reported financial results for the first quarter ended March 31, 2006.
Quarter over quarter results: first quarter 2006 compared to fourth quarter 2005
Revenues for the first quarter of 2006 increased 90% to € 5.4 million compared to € 2.8 million for the previous quarter. Research and development (R&D) expenses decreased 7% to € 14.5 million for the first quarter of 2006 compared to € 15.6 million for the fourth quarter of 2005. General and administrative (G&A) expenses for the first quarter of 2006 decreased 20% to € 4.4 million compared to € 5.5 million for the previous quarter. The Company’s net loss decreased 25% to € (12.9) million in the first quarter of 2006, compared to € (17.2) million for the previous quarter. Basic and diluted loss per share was € (0.41) for the first quarter of 2006 compared to € (0.57) for the previous quarter.
Comparison to previous year: first quarter 2006 compared to first quarter 2005
Revenues for the three months ended March 31, 2006 increased 187% to € 5.4 million compared to € 1.9 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 30% for the first quarter of 2006 to € 14.5 million compared to € 11.2 million for the same period in 2005. The increase was mainly due to activities related to the satraplatin SPARC Phase 3 registrational trial. G&A expenses for the first quarter of 2006 increased 11% to € 4.4 million compared to € 3.9 million for the same quarter in 2005. Net loss for the first quarter of 2006 increased 4% to € (12.9) million compared to € (12.4) million for the first quarter of 2005. Basic and diluted loss per share was € (0.41) for the first quarter of 2006 compared to € (0.42) for the same period in 2005.
As of March 31, 2006, cash, cash equivalents, marketable securities and short-term investments totaled € 144.1 million (December 31, 2005: € 95.2 million), including € 1.6 million in restricted cash. Net cash generated by operating activities was € 12.8 million, and purchases of property, equipment and licenses were € 0.3 million for the first quarter of 2006.
“Our revenues almost tripled compared to the same quarter in 2005 due to our co-development and license agreement with Pharmion,” said Mirko Scherer, Ph.D., Senior Vice President and Chief Financial Officer. “This is the first quarter that the majority of our revenues are a result of our drug development programs and not from technology collaborations.”
“In the first months of 2006, we have continued to build on the good progress made during 2005,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “Importantly, the interim efficacy analysis for the satraplatin Phase 3 trial has now been held by the independent Data Monitoring Board, and the recommendation, as we had expected, was that the trial continue as planned, based on their finding that both the design and conduct of the trial remain sound, no new or unexpected toxicities were observed, and the futility analysis was passed. We thus look forward to reporting the final progression-free survival results this fall.”
Dr. Seizinger continued, “In the meantime, much activity is happening at GPC Biotech as the SPARC registrational trial completes. We have initiated new clinical trials with satraplatin in combination with other anticancer treatments and in a variety of cancer settings. We have also recently expanded our drug development and commercialization management teams with the hiring of three senior executives to fill newly-created positions at the Company. In another step in the planning for our future, we also were able to complete a private placement of € 36 million involving prominent SAP co-founder Dietmar Hopp. The first few months of 2006 have been exciting, and we look forward to continuing our productive year as we move our programs forward.”
Highlights for 2006 year to date
• Independent Data Monitoring Board recommends that GPC Biotech continue satraplatin Phase 3 trial as planned. Data Monitoring Board reports design and conduct of trial remain sound and SPARC trial passes futility analysis
• Company hires three senior executives to fill newly-created positions to expand drug development and commercialization management teams
• Private placement with two investment companies owned by SAP co-founder Dietmar Hopp and his son, respectively, raising € 36.2 million
• New clinical trial opened with satraplatin:
- Phase 1 trial evaluating satraplatin plus Taxotere® (docetaxel) in patients with advanced solid tumors; trial is evaluating a different dosing schedule with Taxotere compared to trial started in mid-2005
• Presentation of new clinical and pre-clinical data on satraplatin, supportive of the clinical work the Company has underway to explore the potential of satraplatin in a variety of combination therapies and cancer settings
• Granting of orphan drug designation for 1D09C3 by European Commission for chronic lymphocytic leukemia and multiple myeloma
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 Thursday, May 4, 2006 at 14:30 CET/8:30 AM EDT. The dial-in numbers for the call are as follows:
European participants: 0049 (0)69 500 71846
U.S. participants: 1-866-770-7146 (toll-free)
GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company’s lead product candidate – satraplatin – has achieved target enrollment 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 GPC Biotech has begun the rolling NDA submission process for this compound. 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). The Company’s wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company’s Web site at www.gpc-biotech.com.
This press release may contain forward-looking statements. Forward-looking statements may be, but are not necessarily, identified by words like “believe”, “anticipate”, “intend”, “expect”, “target”, “goal”, “estimate”, “plan”, “assume”, “may”, “will”, “could” and similar expressions. Forward-looking statements include, but are not limited to, statements about the progress, timing and completion of research, development, pre-clinical studies and clinical trials for the Company’s product candidates; the timing and ultimate success in obtaining regulatory approval in the U.S., Europe or any other jurisdiction for satraplatin or any other product candidates; the Company’s ability to market, commercialize, achieve market acceptance for and sell the Company’s product candidates; the Company’s ability to adequately protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; and the Company’s estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. Forward-looking statements in this press release are based on the Company’s current expectations and projections about future events and are subject to risks, uncertainties and assumptions. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this press release might not occur. We direct you to the Company’s Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission (SEC) for additional details on the important factors that may affect the Company’s future results, performance and achievements. Except as required by law, the Company disclaims any intent or obligation to publicly update or revise these forward-looking statements whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosure the Company makes on its current reports on Form 6-K to the SEC.
Taxotere® (docetaxel) is a registered trademark of Aventis Pharma S.A.
Please click the following link to get the press release with financial tables: (Acrobat Reader Document, approx. 0.2 MB) www.gpc-biotech.com/downloads/eng/pressreleases/050406_PR_Q1_2006_eng.pdf
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- Laurie Doyle
- Associate Director, Investor Relations & Corporate Communications
- GPC Biotech AG
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