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.
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 or +1 609 524 1000
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
David Schull
Phone: +1 858 546-4810
david.schull@eurorscg.com
--- End of Message ---
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