GPC Biotech Reports Financial Results for First Quarter 2009
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announcement.
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* Quarter highlighted by proposed combination of businesses
with U.S. biotechnology firm Agennix in new German company
Martinsried/Munich (Germany) and Princeton, N.J., May 28, 2009 - GPC
Biotech AG (Frankfurt Stock Exchange: GPC) today reported financial
results for the first quarter and three months ended March 31, 2009.
First quarter 2009 compared to first quarter 2008
The Company had no revenues in the first quarter of 2009, compared to
¤ 1.5 million for the first quarter of 2008. The decrease in revenues
is due to the termination of the co-development and license agreement
for satraplatin with Celgene Corporation in September 2008. Research
and development (R&D) expenses decreased 74% to ¤ 1.5 million for the
first three months of 2009 compared to ¤ 5.7 million for the same
period in 2008. The decrease in R&D expenses is primarily due to
staff reductions as a result of the restructuring plan implemented in
2008, a decrease in clinical trial costs and a credit to share-based
compensation expense due to the cancellation of stock options and
convertible bonds. In the first quarter of 2009, administrative
expenses were ¤ 3.5 million compared to ¤ 3.5 million for the first
quarter of 2008. Net loss for the first quarter of 2009 improved 39%
to ¤ (4.3) million compared to ¤ (7.1) million for the first quarter
of 2008. Basic and diluted loss per share was ¤ (0.12) for the first
quarter of 2009 compared to ¤ (0.19) for the same quarter in 2008.
As of March 31, 2009, cash, cash equivalents and available-for-sale
investments totaled ¤ 11.6 million (December 31, 2008: ¤ 32.0
million), including ¤ 0.2 million in restricted cash, which is under
Other Financial Assets on the balance sheet. As previously announced,
in February 2009, in connection with the proposed business
combination with Agennix Incorporated, the Company made a loan to
Agennix in the amount of $20 million (¤ 15.7 million) in the form of
a senior secured convertible promissory note. The proceeds of this
loan are being used to support the clinical development of
talactoferrin prior to the closing of the transaction. Net cash burn
for the first quarter of 2009 was ¤ 4.9 million. Net cash burn is
derived by adding net cash used in operating activities and purchases
of property, equipment and intangible assets. The figures used to
calculate net cash burn are contained in the Company's unaudited
interim consolidated cash flow statement for the first quarter ended
March 31, 2009.
Quarter over quarter results: first quarter 2009 compared to fourth
quarter 2008
For the first quarter of 2009, the Company had no revenues, compared
to ¤ 31,000 for the previous quarter. R&D expenses decreased 56% to ¤
1.5 million for the first quarter of 2009 compared to ¤ 3.4 million
for the fourth quarter of 2008. Administrative expenses for the
first quarter of 2009 decreased 29% to ¤ 3.5 million compared to ¤
4.9 million for the previous quarter. The Company's net loss was
¤ (4.3) million in the first quarter of 2009 compared to ¤
(9.0) million for the previous quarter. Basic and diluted loss per
share was ¤ (0.12) for the first quarter of 2009 compared to ¤ (0.25)
for the previous quarter.
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: "We
are very excited about the proposed combination with Agennix and look
forward to our shareholders voting on the proposed merger agreement
at our annual shareholders' meeting on June 23."
Year-to-date highlights
To date in 2009, the Company has had the following key achievements:
* Business Combination Agreement was signed, under which the
Company proposes to combine businesses with U.S. biotechnology
company, Agennix, Incorporated, in a new German company. Agennix
has an oncology program, talactoferrin, currently in two Phase 3
clinical trials for non-small cell lung cancer. Dievini Hopp
BioTech holding GmbH & Co. KG is investing ¤ 15 million in the
new company.
* New data on satraplatin from the SPARC Phase 3 trial in
second-line castrate- or hormone- refractory prostate cancer were
presented at the American Society for Clinical Oncology (ASCO)
Genitourinary Cancers Symposium. The data showed an improvement
in overall survival in a subset of patients refractory to
docetaxel (Taxotere®).
* New pre-clinical data on RGB-286638 multi-targeted kinase
inhibitor were presented at the American Association for Cancer
Research (AACR) Annual Meeting. The data showed that RGB-286638
demonstrates in vivo activity in several pre-clinical models of
multiple myeloma. The compound has also been shown to induce
cell death in multiple myeloma cells independent from the p53
status; p53 is a gene involved in the control of cell
proliferation. New data in solid tumor cells were also
presented.
Financial guidance
GPC Biotech continues to expect that the average annual cash burn of
the combined entity will be approximately ¤ 30 million for 2009 and
for 2010. This amount excludes one-time total transaction-related
costs of approximately ¤ 7 million, which includes banking and legal
fees associated with the merger for GPC Biotech, Agennix and the new
entity, as well as fees for the listing of the new entity on the
Frankfurt Stock Exchange. GPC Biotech expects that the existing cash
of GPC Biotech and Agennix, plus the cash contribution of dievini
Hopp BioTech holding as part of the proposed merger, will be
sufficient to fund operations of the combined entity into the second
quarter of 2010. GPC Biotech believes that it should have sufficient
cash as a stand-alone entity to close the proposed merger, depending
on the actual closing date. If the merger is not completed in a
timely manner or at all, the ability of GPC Biotech to continue as a
going concern on a stand-alone basis will be at risk.
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 May 28
at 15:00 CET/9:00 AM ET. The dial-in numbers for the call are as
follows:
Participants from Europe: 0049 (0)69 667775756 or 0044 (0)20 3003
2666
Participants from the U.S.: 1-646-843-4608
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 developing anti-cancer drugs. The Company currently has two
programs in clinical development: satraplatin, an oral platinum
compound and RGB-286638, a multi-targeted protein kinase inhibitor.
On February 18, 2009, the Company announced plans to combine its
business with U.S.-based Agennix, Incorporated in a new German
company. Agennix, a privately held biotechnology company, is
developing oral talactoferrin, a product candidate that is currently
in Phase 3 trials for non-small cell lung cancer. GPC Biotech AG is
headquartered in Martinsried/Munich (Germany) and has a wholly owned
U.S. subsidiary in 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. 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. There can
be no guarantee that the proposed merger will be approved by GPC
Biotech shareholders or will close in a timely manner, if at all.
Forward-looking statements speak only as of the date on which they
are made and GPC Biotech undertakes no obligation to update these
forward-looking statements, even if new information becomes available
in the future.
Taxotere® is a registered trademark of Aventis Pharma S.A.
For further information, please contact:
GPC Biotech AG
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: +1 609-524-5884
usinvestors@gpc-biotech.com
Additional media contacts for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
Raimund Gabriel
raimund.gabriel@mc-services.eu
Hilda Juhasz
hilda.juhasz@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Rigg, Vice President
Phone: +44 207 936 9325
lrigg@troutgroup.com
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GPC Biotech AG
Fraunhoferstr. 20 Martinsried Germany
WKN: 585150;
ISIN: DE0005851505; Index: CDAX, Prime All Share, TECH All Share,
DAX;
Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in
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Düsseldorf,
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Wertpapierbörse zu Hamburg,
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in Frankfurter Wertpapierbörse;