* Cash and cash equivalents of euro 95.2 million as of December 31, 2005;
further strengthened by additional euro 67.5 million received in Q1
2006
* Year highlighted by key achievements:
-- Completion of patient enrollment in satraplatin Phase 3
registrational trial
-- Start of rolling NDA submission
-- Signing of major co-development and license agreement with Pharmion,
worth up to $ 270 million plus royalties on net sales
* Revenues in 2006 expected to about double
MARTINSRIED/MUNICH, Germany, March 15 /PRNewswire-FirstCall/ -- U.S.
Research and Development Facilities in Waltham/Boston Mass. and Princeton N.J.
-- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB)
today reported financial results for the fourth quarter and fiscal year ended
December 31, 2005.
Quarter over quarter results: fourth quarter 2005 compared to third
quarter 2005
Revenues for the fourth quarter of 2005 increased 33% to euro 2.8 million
compared to euro 2.1 million for the previous quarter. Research and
development (R&D) expenses increased 5% to euro 15.6 million for the fourth
quarter of 2005 compared to euro 14.8 million for the third quarter of 2005.
General and administrative (G&A) expenses for the fourth quarter of 2005
increased 20% to euro 5.5 million compared to euro 4.6 million for the
previous quarter. The Company's net loss increased 4% to euro (17.2) million
in the fourth quarter of 2005, compared to euro (16.5) million for the
previous quarter. Basic and diluted loss per share was euro (0.57) for the
fourth quarter of 2005 compared to euro (0.55) for the previous quarter.
Comparison to previous year: fourth quarter 2005 compared to fourth
quarter 2004
Revenues for the three months ended December 31, 2005 decreased 20% to
euro 2.8 million compared to euro 3.5 million for the same period in 2004.
R&D expenses increased 27% for the fourth quarter of 2005 to euro 15.6 million
compared to euro 12.3 million for the same period in 2004. G&A expenses for
the fourth quarter of 2005 increased 41% to euro 5.5 million compared to euro
3.9 million for the same quarter in 2004. Net loss for the fourth quarter of
2005 increased 25% to euro (17.2) million compared to euro (13.8) million for
the fourth quarter of 2004. Basic and diluted loss per share was euro (0.57)
for the fourth quarter of 2005 compared to euro (0.50) for the same period in
2004.
Fiscal year 2005 compared to fiscal year 2004
As anticipated, revenues decreased 26% to euro 9.3 million for the fiscal
year ended December 31, 2005, compared to euro 12.6 million for the same
period in 2004. As the ongoing collaboration with ALTANA Pharma matures, the
expected reduction in revenues under this collaboration led to the reduction
in total revenues compared to the previous year. No revenues from the co-
development and license agreement with Pharmion were recognized in fiscal year
2005. R&D expenses increased 39% to euro 55.7 million for 2005 compared to
euro 40.0 million for 2004. The increase was mainly due to increased drug
development activities, including the continued ramp-up of patient enrollment
in the satraplatin SPARC Phase 3 registrational trial, as well as increased
drug discovery efforts following the acquisition of the assets of Axxima
Pharmaceuticals in early 2005. In 2005, G&A expenses amounted to euro 20.6
million. G&A expenses for 2005 include a charge related to the contractual
loss on a sublease of euro 3.0 million. Excluding this charge related to the
sublease, G&A expenses increased 33% to euro 17.6 million compared to euro
13.2 million for 2004. Net loss increased 56% to euro (62.2) million compared
to euro (39.9) million for 2004. Basic and diluted loss per share was euro
(2.08) compared to euro (1.60) for 2004.
As of December 31, 2005, cash, cash equivalents, marketable securities and
short-term investments totaled euro 95.2 million (December 31, 2004: euro
131.0 million), including euro 1.6 million in restricted cash. The net cash
burn was euro 47.3 million for 2005. Net cash burn is derived by adding net
cash used in operating activities (euro 42.8 million) and purchases of
property, equipment and licenses (euro 4.5 million). The figures used to
calculate net cash burn are contained in the Company's consolidated statements
of cash flows for the twelve-month period ended December 31, 2005. Net cash
burn was euro 10.8 million for the fourth quarter of 2005, euro 12.9 million
for the third quarter of 2005, euro 11.9 million for the second quarter of
2005 and euro 11.6 million for the first quarter of 2005.
Of note, in the first quarter of 2006, the Company received an additional
euro 67.5 million from an upfront development-related payment of euro 31.3
million from its partner Pharmion in connection with the co-development and
license agreement signed in December 2005 and euro 36.2 million through a
private placement with two investment companies owned by SAP co-founder
Dietmar Hopp and his son, respectively.
"Our financial results for 2005 continue to reflect our expanding efforts
to successfully develop our anticancer pipeline, especially satraplatin," said
Mirko Scherer, Ph.D., Senior Vice President and Chief Financial Officer. "We
expect revenues to approximately double in 2006 compared to 2005. For 2006 we
expect R&D expenses to increase moderately compared to 2005 as regulatory-
related expenses increase and we initiate new and expand existing clinical
trials. Fortunately, our agreement with Pharmion provides us substantial
development-related funding as we move satraplatin forward. This important
collaboration, in addition to our recent private placement, puts us in a
strong financial position at such an important time for our Company."
"During 2005, we took critically important steps to build a sustainable
future for GPC Biotech," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive
Officer. "We had several key achievements with our lead drug candidate
satraplatin, including reaching target accrual in December in our Phase 3
registrational trial -- the SPARC trial -- making this one of the fastest-
accruing Phase 3 trials for a chemotherapy drug ever to be conducted in
prostate cancer. Also in December, we started the rolling NDA submission with
the U.S. FDA. In addition to advancing the registrational trial in prostate
cancer, we initiated several additional clinical trials for satraplatin, to
broadly explore its anti-cancer activity in various other important tumor
types, such as breast cancer and non-small cell lung cancer. The year
culminated with the signing of a co-development and license agreement with
Pharmion for the commercialization of satraplatin in Europe and certain other
territories. Under this agreement, we could receive up to $270 million in
total payments based upon the achievement of regulatory and sales milestones,
in addition to significant royalties on net sales. We also advanced a second
anticancer drug candidate -- the monoclonal antibody 1D09C3 -- into the clinic
and acquired substantially all of the assets and hired many of the discovery
scientists of another biotechnology company to enhance our own oncology drug
discovery engine."
Dr. Seizinger continued, "The year 2006 promises to be even more important
as we expect to see efficacy data from our Phase 3 registrational trial for
satraplatin. Provided these data are positive, our goal is to then complete
the NDA filing for marketing approval of satraplatin in the U.S. by the end of
this year and file through our partner Pharmion in Europe in the first quarter
of 2007. We look forward to another successful year as we continue to drive
forward satraplatin, as well as our other anticancer programs."
Highlights since third quarter of 2005 update
Satraplatin
* Signing of co-development and license agreement with Pharmion for the
commercialization of satraplatin in Europe, the Middle East, Australia
and New Zealand, involving a payment of $37.1 (euro 31.3) million
already received by GPC Biotech and in total payments of up to $270
million based upon the achievement of regulatory and sales milestones
plus royalties
* Satraplatin Phase 3 registrational trial (SPARC) fully accrued with a
total of 950 patients
* Start rolling NDA submission for satraplatin -- CMC section submitted to
U.S. FDA
* Start of Phase 2 trial evaluating satraplatin in patients with
metastatic breast cancer
* Start of Phase 2 trial evaluating satraplatin plus Taxol(R) in patients
with advanced non-small cell lung cancer
* Start of Phase 1 trial evaluating satraplatin plus Taxotere(R) in
patients with advanced solid tumors; trial is evaluating a different
dosing schedule with Taxotere compared to trial started in mid-2005
Additional achievements
* Private placement with two investment companies owned by SAP co-founder
Dietmar Hopp and his son, respectively, raising euro 36.2 million
* Start of additional Phase 1 clinical trial with 1D09C3 anticancer
monoclonal antibody
* Granting of orphan drug designation for 1D09C3 by European Commission
for chronic lymphocytic leukemia and multiple myeloma
Company provides update on satraplatin SPARC Phase 3 registrational trial
GPC Biotech also provided an update on the SPARC trial, which is
evaluating satraplatin plus prednisone as a second-line chemotherapy treatment
for hormone-refractory prostate cancer (HRPC). The Company reported that a
total of 950 patients had been enrolled in the trial, with 60% of patients
from Europe, 27% from the U.S. and Canada and 13% from South America. The
Company also reported that the independent Data Monitoring Board for the SPARC
trial has now set a date for the interim efficacy analysis, which will be held
in late April. The Company reiterated its expectation that the trial will
continue to its completion, with full progression-free survival data available
in the second half of 2006.
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 http://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 Wednesday, March 15, 2006 at 14:00
CET/8:00 AM EST. The dial-in numbers for the call are as follows:
European participants: 0049 (0)69 500 71846
U.S. participants: 1-800-599-9816 (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 http://www.gpc-
biotech.com.
This press release may contain forward-looking statements, including
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. These
forward-looking statements 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 Annual Report on Form 20-F, as amended, for the
fiscal year ended December 31, 2004 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.
Taxol(R) (paclitaxel) is a registered trademark of Bristol-Myers Squibb
Company.
Taxotere(R) (docetaxel) is a registered trademark of Aventis Pharma S.A.
For further information, please contact:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
Martin Braendle
Associate Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.:
Laurie Doyle
Associate Director, Investor Relations & Corporate Communications
Phone: +1 781 890 9007 X267
usinvestors@gpc-biotech.com
Additional Media Contact:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
-- Financials follow --
Consolidated Statements of Operations (U.S. GAAP)
in thousand euro, except
share and per share data 2005 2004 Q4 2005 Q4 2004
Collaborative revenues (a) 9,341 12,649 2,847 3,503
Total revenues 9,341 12,649 2,847 3,503
Research and development
expenses 55,684 39,955 15,632 12,300
General and
administrative
expenses 20,590 13,173 5,475 3,878
In-process research and
development 683 - - -
Amortization of
intangible assets 417 413 145 266
Total operating expenses 77,374 53,541 21,252 16,444
Operating loss (68,033) (40,892) (18,405) (12,941)
Other income
(expense), net 2,938 (1,554) 716 (1,636)
Interest income 2,963 2,618 501 793
Interest expense (75) (99) (14) (26)
Net loss (62,207) (39,927) (17,202) (13,810)
Basic and diluted net
loss per share, in euro (2.08) (1.60) (0.57) (0.50)
Shares used in computing
basic and diluted loss
per share 29,877,348 24,950,638 30,128,448 28,704,436
(a) Revenues from
related party
Collaborative
revenues 9,095 12,588 2,791 3,442
See accompanying notes to consolidated financial statements.
Consolidated Balance Sheets (U.S. GAAP)
in thousand euro, except share data and
per share data
December 31,
Assets 2005 2004
Current assets
Cash and cash equivalents 30,559 59,421
Marketable securities and short-term
investments 63,061 69,248
Accounts receivable 31,326 -
Accounts receivable, related party 1,436 1,006
Prepaid expenses 1,333 1,170
Other current assets 3,920 4,211
Total current assets 131,635 135,056
Property and equipment, net 4,103 2,615
Intangible assets, net 1,072 1,133
Other assets, non-current 838 768
Restricted cash 1,615 2,321
Total assets 139,263 141,893
Liabilities and shareholders' equity
Current liabilities
Accounts payable 2,141 519
Accrued expenses and other current liabilities 11,274 6,910
Current portion of deferred revenue,
related party 5,228 4,938
Current portion of deferred revenue 19,548 -
Total current liabilities 38,191 12,367
Deferred revenues, related party,
net of current portion 975 2,925
Deferred revenue, net of current portion 12,053 -
Convertible bonds 2,334 1,768
Other liabilities, non-current 2,177 -
Shareholders' equity
Ordinary shares, euro 1 non-par, notional value;
Shares authorized: 53,780,630 at December 31, 2005
and 51,655,630 at December 31, 2004
Shares issued and outstanding: 30,151,757
at December 31, 2005 and 28,741,194
at December 31, 2004 30,152 28,741
Additional paid-in capital 284,931 266,074
Accumulated other comprehensive loss (2,093) (2,732)
Accumulated deficit (229,457) (167,250)
Total shareholders' equity 83,533 124,833
Total liabilities and shareholders' equity 139,263 141,893
See accompanying notes to consolidated financial statements.
Consolidated Statements of Cash Flows (U.S. GAAP)
Years Ended December 31,
in thousand euro 2005 2004
Cash flows from operating activities
Net loss (62,207) (39,927)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation 3,478 1,568
Amortization 417 413
Compensation cost for stock option plans
and convertible bonds 6,665 3,451
Loss accrual on sublease contract 2,988 -
Acquired in-process research and development 683 -
Change in accrued interest income on
marketable securities and short-term
investments 478 (556)
Bond premium amortization 629 513
(Gain)/loss on disposal of property and
equipment (83) 56
(Gain)/loss on marketable securities and
short-term investments - 841
Changes in operating assets and liabilities:
Accounts receivable, related party (430) (1,006)
Accounts receivable (31,325) 754
Other assets, current and non-current 1,550 (1,987)
Accounts payable 1,552 (96)
Deferred revenue, related party (1,671) (2,241)
Deferred revenue 31,602 (165)
Other liabilities and accrued expenses 2,887 566
Net cash used in operating activities (42,787) (37,816)
Cash flows from investing activities
Purchases of property, equipment and licenses (4,549) (1,071)
Proceeds from the sale of property and equipment 187 -
Proceeds from sale of marketable securities and
short-term investments 35,803 4,289
Purchases of marketable securities and
short-term investments (31,408) (20,267)
Net cash (used in) provided by investing
activities 33 (17,049)
Cash flows from financing activities
Proceeds from issuance of shares in asset
acquisition, net of payments for costs of
transaction 10,412 -
Proceeds from equity offering, net of
payments for costs of transaction - 77,976
Proceeds from issuance of convertible bonds 580 935
Repayment of convertible bonds (8) (4)
Proceeds from exercise of stock options and
convertible bonds 517 2,038
Principal payments under capital lease obligations - (634)
Principal payments of loans - (639)
Net cash provided by financing activities 11,501 79,672
Effect of exchange rate changes on cash 1,393 (314)
Changes in Restricted cash 998 (19)
Net increase/(decrease) in cash and cash
equivalents (28,862) 24,474
Cash and cash equivalents at the beginning
of the year 59,421 34,947
Cash and cash equivalents at the end of the
year 30,559 59,421
Supplemental Information:
Cash paid for interest 107 63
Non-cash investing and financing activities:
Net assets acquired in exchange for shares
in connection with asset acquisition 2,667 -
See accompanying notes to consolidated financial statements.
Consolidated Statements of Changes in Shareholders' Equity (U.S. GAAP)
Ordinary shares Additional
in thousand euro, Paid- Subscribed
except share data Shares Amount in Capital Shares
Balance as of
December 31, 2003 20,754,075 20,754 190,335 215
Components of
comprehensive loss:
Net loss
Change in unrealized
gain on
available-for-sale
securities
Accumulated translation
adjustments
Total comprehensive
loss
Issuance of shares in
equity offering 7,160,000 7,160 70,816
Exercise of stock
options and convertible
bonds 827,119 827 1,472 (215)
Compensation costs for
stock options and
convertible bonds 3,451
Balance as of
December 31, 2004 28,741,194 28,741 266,074 -
Components of comprehensive loss:
Net loss
Change in unrealized
gain on
available-for-sale
securities
Accumulated translation
adjustments
Total comprehensive
loss
Issuance of shares in
asset acquisition 1,311,098 1,311 11,768
Exercise of stock
options and
convertible bonds 99,465 100 424
Compensation costs for
stock options and
convertible bonds 6,665
Balance as of
December 31, 2005 30,151,757 30,152 284,931 -
See accompanying notes to consolidated financial statements.
Consolidated Statements of Changes in Shareholders' Equity (U.S. GAAP)
Accumulated
Other Total
in thousand euro, except Comprehensive Accumulated Shareholders'
share data Loss Deficit Equity
Balance as of December 31, 2003 (2,102) (127,323) 81,879
Components of comprehensive loss:
Net loss (39,927) (39,927)
Change in unrealized gain on
available-for-sale securities (154) (154)
Accumulated translation
adjustments (476) (476)
Total comprehensive loss (40,557)
Issuance of shares in equity
offering 77,976
Exercise of stock options and
convertible bonds 2,084
Compensation costs for stock
options and convertible bonds 3,451
Balance as of December 31, 2004 (2,732) (167,250) 124,833
Components of comprehensive loss:
Net loss (62,207) (62,207)
Change in unrealized gain on
available-for-sale securities (684) (684)
Accumulated translation
adjustments 1,323 1,323
Total comprehensive loss (61,568)
Issuance of shares in asset
acquisition 13,079
Exercise of stock options and
convertible bonds 524
Compensation costs for stock
options and convertible bonds 6,665
Balance as of December 31, 2005 (2,093) (229,457) 83,533
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
CONTACT:
Martin Braendle, Associate Director, Investor
Relations & Corporate Communications, +49 (0)89 8565-2693,
ir@gpc-biotech.com, or Laurie Doyle, Associate Director, Investor
Relations & Corporate Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or Brian
Hudspith of Maitland Noonan Russo, +44 (0)20 7379 5151,
bhudspith@maitland.co.uk
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