GPC Biotech Reports Financial Results for Second Quarter and First Six Months of 2006
• Revenues increased 126% in second quarter 2006 compared to the same period in 2005
• Cash and equivalents € 128 million (~$160 million) as of June 30, 2006
Martinsried/Munich (Germany), Waltham, Mass. and Princeton, N.J., August 8, 2006 - GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30; NASDAQ: GPCB) today reported financial results for the second quarter and first six months ended June 30, 2006.
Quarter over quarter results: second quarter 2006 compared to first quarter 2006
Revenues for the second quarter of 2006 were € 5.6 million compared to € 5.4 million for the previous quarter. Research and development (R&D) expenses were € 14.5 million for the second quarter of 2006, practically unchanged from the first quarter of 2006. General and administrative (G&A) expenses for the second quarter of 2006 increased 33% to € 5.8 million compared to € 4.4 million for the previous quarter. The Company’s net loss increased 18% to € (15.2) million in the second quarter of 2006, compared to € (12.9) million for the previous quarter. Basic and diluted loss per share was € (0.46) for the second quarter of 2006 compared to € (0.41) for the previous quarter.
Comparison to previous year: second quarter 2006 compared to second quarter 2005
Revenues for the three months ended June 30, 2006 increased 126% to € 5.6 million compared to € 2.5 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 4% for the second quarter of 2006 to € 14.5 million compared to € 13.9 million for the same period in 2005. G&A expenses for the second quarter of 2006 decreased 12% to € 5.8 million compared to € 6.6 million for the same quarter in 2005. G&A expenses for the second quarters of both 2005 and 2006 include a non-cash charge related to a contractual loss on a sublease. This charge was € 1.0 million for the second quarter of 2006 compared to € 2.8 million for the same period in 2005. Net loss for the second quarter of 2006 decreased 5% to € (15.2) million compared to € (16.0) million for the second quarter of 2005. Basic and diluted loss per share was € (0.46) for the second quarter of 2006 compared to € (0.53) for the same period in 2005.
First six months of 2006 compared to first six months of 2005
Revenues increased 152% to € 11.0 million for the six months ended June 30, 2006, compared to € 4.4 million for the same period in 2005. Research and development (R&D) expenses increased 16% to € 29.1 million for the first six months of 2006 compared to € 25.1 million for the same period in 2005. In the first six months of 2006, general and administrative (G&A) expenses decreased 3% to € 10.2 million compared to € 10.5 million for the first six months of 2005. Net loss for the first six months of 2006 decreased 1% to € (28.1) million compared to € (28.4) million for the first six months of 2005. Basic and diluted loss per share was € (0.87) for the first six months of 2006 compared to € (0.96) for the same period in 2005.
As of June 30, 2006, cash, cash equivalents, marketable securities and short-term investments totaled
€ 127.9 million (December 31, 2005: € 95.2 million), including € 1.6 million in restricted cash. Net cash burn for the first six months of 2006 was € 3.6 million with net cash generated of € 12.8 million in the first quarter of 2006 and net cash burn of € 16.2 million for the second 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 six-month period ended June 30, 2006.
“Our revenues more than doubled in the second quarter of 2006 compared to the same period in 2005 due to our co-development and license agreement with Pharmion, and we are on track to reach our revenue goal of approximately doubling revenues for the full year 2006,” said Mirko Scherer, Ph.D., Senior Vice President and Chief Financial Officer. “Our solid financial position is enabling us to move forward rapidly as we plan for the commercialization of satraplatin, in addition to developing our pipeline by initiating new trials with our lead drug candidate and advancing other programs.”
“The first half of 2006 was a busy time for GPC Biotech as we put into place critical elements to achieve the next stage in our corporate development, including key senior executive hires for our clinical development, and commercialization management teams,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “The second half of this year will be a pivotal time for us as we anticipate the final results on progression-free survival from our SPARC Phase 3 registrational trial for satraplatin within the next ten weeks. If positive, we expect to complete our NDA filing with the FDA by year end and continue advancing our marketing and sales plans for the successful launch of satraplatin.”
Highlights from the second quarter of 2006 and later
• Company hires three senior executives to fill newly-created positions to expand drug development and commercialization management teams
• Independent Data Monitoring Board recommends that GPC Biotech continue satraplatin Phase 3 trial as planned following interim analyses of progression-free survival and also of overall survival
• Non-clinical section of rolling NDA submitted to FDA for satraplatin
• 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
• New clinical trials opened with satraplatin:
- Phase 2 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
- Two Phase 1 trials evaluating satraplatin plus Xeloda in patients with advanced solid tumors; first studies initiated that are evaluating satraplatin in combination with another oral chemotherapy treatment.
- Phase 1 study evaluating satraplatin in combination with Gemzar® (gemcitabine) in patients with advanced solid tumors
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 August 8 at 14:30 CET/8:30 AM EDT.
The dial-in numbers for the call are as follows:
European participants: 0049-69-5007-1846
U.S. participants: 1-866-578-5801 (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.
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.
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/080806_PR_Q206_eng.pdf
- Contact Information
- Laurie Doyle
- Director, Investor Relations & Corporate Communications
- GPC Biotech AG
- Contact via E-mail
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