- Revenues increased by 143% in 2006 compared to 2005
- Cash and cash equivalents of euro 97.1 million as of December 31, 2006;
further strengthened by additional euro 33.6 million gross proceeds raised
in Q1 2007
- Year highlighted by positive data from satraplatin Phase 3 registrational
trial
- Highly statistically significant results for improvement in
progression-free survival
MARTINSRIED/MUNICH, Germany, March 15 /PRNewswire-FirstCall/ -- U.S.
Research and Development Facilities in WALTHAM, Mass. and PRINCETON, N.J.,
-- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30; Nasdaq: GPCB)
today reported financial results for the fourth quarter and fiscal year
ended December 31, 2006.
Fiscal year 2006 compared to fiscal year 2005
Revenues increased 143% to euro 22.7 million for the fiscal year ended
December 31, 2006, compared to euro 9.3 million for 2005. The increase in
revenues is due to development funding received under the co-development
and license agreement for satraplatin for Europe and certain other
territories with Pharmion that was signed in December 2005. Research and
development (R&D) expenses increased 16% to euro 64.7 million for 2006
compared to euro 55.7 million for 2005. This increase was mainly due to
expenses related to satraplatin, such as expenses for clinical trials and
the accrual of a milestone obligation to Spectrum Pharmaceuticals, Inc. in
the amount of USD $6 million, which will become due upon the acceptance for
filing of a New Drug Application (NDA) for satraplatin by the U.S. FDA and
the acceptance of the Marketing Authorization Application (MAA) in Europe.
In 2006, general and administrative (G&A) expenses increased 16% to euro
23.8 million compared to euro 20.6 million for 2005. Net loss for the
fiscal year 2006 increased 3% to euro (64.0) million compared to euro
(62.2) million for 2005. Basic and diluted loss per share was euro (1.95)
for 2006 compared to euro (2.08) for 2005.
As of December 31, 2006, cash, cash equivalents, marketable securities
and short-term investments totaled euro 97.1 million (December 31, 2005:
euro 95.2 million), including euro 1.5 million in restricted cash. Net cash
burn for the fiscal year 2006 was euro 38.5 million with net cash generated
of euro 12.5 million in the first quarter of 2006, net cash burn of euro
16.1 million for the second quarter of 2006, net cash burn of euro 14.6
million for the third quarter and of euro 20.3 million for the fourth
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 consolidated statements of cash flows for the
fiscal year ended December 31, 2006.
Quarter over quarter results: fourth quarter 2006 compared to third
quarter 2006
Revenues for the fourth quarter of 2006 were euro 5.1 million compared
to euro 6.6 million for the previous quarter. R&D expenses were euro 15.6
million for the fourth quarter of 2006 compared to euro 20.1 million for
third quarter of 2006. G&A expenses for the second quarter were euro 7.6
million compared to euro 6.1 million for the previous quarter. The
Company's net loss decreased to euro (17.2) million in the fourth quarter
of 2006 compared to euro (18.7) million for the previous quarter. Basic and
diluted loss per share was euro (0.50) for the fourth quarter of 2006
compared to euro (0.57) for the previous quarter.
Comparison to previous year: fourth quarter 2006 compared to fourth
quarter 2005
Revenues for the three months ended December 31, 2006 increased 79% to
euro 5.1 million compared to euro 2.8 million for the same period in 2005.
R&D expenses for the fourth quarter of 2006 were stable at euro 15.6
million compared to euro 15.6 million for the fourth quarter of 2005. G&A
expenses for the fourth quarter of 2006 were euro 7.6 million compared to
euro 5.5 million for the same quarter in 2005. Net loss for the fourth
quarter of 2006 was stable at euro (17.2) million compared to euro (17.2)
million for the fourth quarter of 2005. Basic and diluted loss per share
was euro (0.50) for the fourth quarter of 2006 compared to euro (0.57) for
the same period in 2005.
"Our revenues increased by 143% in 2006 compared to the previous year
due to development funding received under our co-development and license
agreement with Pharmion. This is the highest annual revenue figure in the
history of GPC Biotech," said Mirko Scherer, Ph.D., Senior Vice President
and Chief Financial Officer.
"The year 2006 was the most significant year to date in the history of
GPC Biotech, highlighted by the positive topline data from the satraplatin
Phase 3 registrational trial in second-line hormone-refractory prostate
cancer that we announced in the fall. To explore potential additional uses
for satraplatin, we initiated a number of clinical trials exploring
satraplatin in combination with a variety of anticancer treatments and in
various cancer types. We are also moving forward with other anticancer
programs in our pipeline. In December 2006, for example, we presented the
first clinical data with our second product candidate, 1D09C3, a monoclonal
antibody against lymphoid tumors," said Bernd R. Seizinger, M.D., Ph.D.,
Chief Executive Officer.
Dr. Seizinger continued: "The year 2007 promises to be another pivotal
year for GPC Biotech as we progress through the regulatory process for
satraplatin in the U.S. and - in cooperation with our partner Pharmion - in
Europe. We expect that the U.S. FDA will reach a decision on our NDA filing
for satraplatin during 2007."
Highlights: fourth quarter 2006 and year-to-date 2007
-- Private placement with institutional investors raising gross proceeds
of euro 33.6 million (~$43.7 million)
-- Rolling submission of an NDA to the U.S. FDA for satraplatin completed
-- Final progression-free survival (PFS) results for the satraplatin SPARC
Phase 3 registrational trial in second-line chemotherapy for hormone-
refractory prostate cancer presented at the ASCO Prostate Cancer
Symposium in Orlando, Florida
-- Satraplatin Expanded Rapid Access protocol (SPERA) launched in the U.S.
-- Preliminary clinical data on anticancer monoclonal antibody 1D09C3
presented at the 48th Annual Meeting of the American Society of
Hematology (ASH) in Orlando, Florida
Financial outlook 2007
Revenues: The Company expects revenues to remain stable in 2007
compared to 2006.
The primary source of revenue for 2007 is expected to be from the
Company's co-development and licensing agreement with Pharmion.
Expenses: For 2007 the Company expects R&D expenses to be slightly
higher than 2006.
The Company plans to continue to open more Phase 1 and 2 clinical
trials with satraplatin in combination with other drugs and in other cancer
types. In addition to the milestones to Spectrum Pharmaceuticals that the
Company already accrued for in the third quarter of 2006, GPC Biotech is
obligated to pay Spectrum an undisclosed milestone payment should
satraplatin be granted marketing approval in the U.S. GPC Biotech is
obligated to pay Spectrum a certain percentage of milestone payments GPC
Biotech receives under any sublicense agreements, such as the agreement
with Pharmion.
Selling, general and administrative expenses are expected to increase
significantly during 2007 as the Company prepares for the launch of
satraplatin.
Cash burn: For 2007, cash burn is expected to be higher than in 2006,
mainly driven by significant outlays in preparation for the
commercialization of satraplatin, including the ordering of commercial
supplies.
Corporate calendar
Two dates in the corporate calendar have changed. The report on the
financial results for the first quarter of 2007 will now be published on
May 15, 2007 (previously scheduled for May 8). The Annual Shareholders
Meeting will now be held on May 25, 2007 in Munich instead of June 6. All
other 2007 financial reporting dates remain the same and are posted on the
Company's Web site at http://www.gpc-biotech.com.
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 March 15th at 14:00 CET/9:00 AM
ET. The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0)69 9897 2633 or 0044 (0)20 7365 1832
Participants from the U.S.: 1-718-354-1171
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 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 has
been completed. 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 http://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.
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, 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
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 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.
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
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
David Schull
Phone: +1 212 845-4271
david.schull@eurorscg.com
Condensed Consolidated Statements of Operations (U.S. GAAP)
in thousand euro, except
share and per share data 2006 2005 Q4 2006 Q4 2005
Collaborative revenues (a) 22,252 9,341 4,949 2,847
Grant revenues 422 - 142 -
Total revenues 22,674 9,341 5,091 2,847
Research and development
expenses 64,707 55,684 15,581 15,632
General and administrative
expenses 23,834 20,590 7,587 5,475
In-process research and
development - 683 - -
Amortization of intangible
assets 325 417 112 145
Total operating expenses 88,866 77,374 23,280 21,252
Operating loss (66,192) (68,033) (18,189) (18,405)
Other income (expense), net (2,316) 2,938 (64) 716
Interest income 4,152 2,963 1,032 501
Interest expense (90) (75) (25) (14)
Net loss before cumulative
effect of change in
accounting principle (64,446) (62,207) (17,246) (17,202)
Cumulative effect of change
in accounting principle 433 - - -
Net loss (64,013) (62,207) (17,246) (17,202)
Loss per share before change
in accounting principle (1.95) (2.08) (0.50) (0.57)
Cumulative effect of change
in accounting principle 0.01 - - -
Basic and diluted loss per
share, in euro (1.94) (2.08) (0.50) (0.57)
Shares used in computing
basic and diluted loss
per share 33,840,480 29,877,348 33,750,609 30,128,448
(a) Revenues from related
party Collaborative revenues 7,054 9,095 1,227 2,791
See accompanying notes to unaudited condensed consolidated financial
statements.
GPC Biotech AG
Condensed Consolidated Balance Sheets (U.S. GAAP)
in thousand euro, except share data and per
share data
December 31
Assets 2006 2005
Current assets
Cash and cash equivalents 38,336 30,559
Marketable securities and short-term
investments 57,186 63,061
Accounts receivable 11 31,326
Accounts receivable, related party 395 1,436
Prepaid expenses 1,299 1,333
Other current assets 2,970 3,920
Total current assets 100,197 131,635
Property and equipment, net 4,259 4,103
Intangible assets, net 405 1,072
Other assets, non-current 1,127 838
Restricted cash 1,531 1,615
Total assets 107,519 139,263
Liabilities and shareholders' equity
Current liabilities
Accounts payable 2,262 2,141
Accrued expenses and other current liabilities 14,346 11,274
Current portion of deferred revenue,
related party 896 5,228
Current portion of deferred revenue 7,240 19,548
Total current liabilities 24,744 38,191
Deferred revenues, related party, net of
current portion - 975
Deferred revenue, net of current portion 9,103 12,053
Convertible bonds 3,108 2,334
Other liabilities, non-current 3,389 2,177
Shareholders' equity
Ordinary shares, euro 1 non-par, notional value;
Shares authorized: 62,695,630 at December 31,
2006 and 53,780,630 at December 31, 2005
Shares issued and outstanding: 33,895,444
at December 31, 2006 and 30,151,757 at
December 31, 2005 33,895 30,152
Additional paid-in capital 328,171 284,931
Subscribed shares 334 -
Accumulated other comprehensive loss (1,755) (2,093)
Accumulated deficit (293,470) (229,457)
Total shareholders' equity 67,175 83,533
Total liabilities and shareholders' equity 107,519 139,263
See accompanying notes to unaudited condensed consolidated financial
statements.
Condensed Consolidated Statements of Cash Flows (U.S. GAAP)
December 31,
in thousand euro 2006 2005
Cash flows from operating activities
Net loss (64,013) (62,207)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation 1,532 3,478
Amortization 325 417
Compensation cost for stock option plans
and convertible bonds 6,938 6,665
Loss accrual on sublease contract 2,161 2,988
Acquired in-process research and development - 683
Cumulative effect of change in accounting
principle (433) -
Change in accrued interest income on
marketable securities and short-term investments 293 478
Bond premium amortization 562 629
Other-than-temporary impairment on marketable
securities 390 -
Gain on disposal of property and equipment (24) (83)
Changes in operating assets and liabilities:
Accounts receivable, related party 1,041 (430)
Accounts receivable 31,313 (31,325)
Other assets, current and non-current 548 1,550
Accounts payable 271 1,552
Deferred revenue, related party (5,307) (1,671)
Deferred revenue (15,259) 31,602
Other liabilities and accrued expenses 3,040 2,887
Net cash used in operating activities (36,622) (42,787)
Cash flows from investing activities
Purchases of property, equipment and licenses (1,878) (4,549)
Proceeds from the sale of property and equipment 45 187
Proceeds from the sale or maturity of
marketable securities and short-term
investments 20,445 35,803
Purchases of marketable securities and
short-term investments (19,906) (31,408)
Net cash provided by investing activities 3,706 33
Cash flows from financing activities
Proceeds from issuance of shares, net of
payments for cost of transaction 36,080 -
Proceeds from issuance of shares in asset
acquisition, net of payments for costs
of transaction - 10,412
Proceeds from issuance of convertible bonds 970 580
Payments for cancellation of convertible bonds - (8)
Proceeds from exercise of stock options and
convertible bonds 4,209 517
Cash received for subscribed shares 334 -
Net cash provided by financing activities 41,593 11,501
Effect of exchange rate changes on cash (835) 1,393
Changes in restricted cash (65) 998
Net increase/(decrease) in cash and cash
equivalents 7,777 (28,862)
Cash and cash equivalents at the beginning
of the period 30,559 59,421
Cash and cash equivalents at the end
of the period 38,336 30,559
Supplemental Information:
Cash paid for interest 94 107
Non-cash investing and financing activities:
Net assets acquired in exchange for shares
in connection with asset acquisition - 2,667
See accompanying notes to unaudited condensed consolidated financial
statements.
Condensed 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, 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, stock
options and convertible
bonds 6,665
Balance as of December
31, 2005 30,151,757 30,152 284,931 -
Balance as of December
31, 2005 30,151,757 30,152 284,931 -
Components of comprehensive
loss:
Net loss
Change in unrealized gain
on available-for-sale
securities
Accumulated translation
adjustments
Total comprehensive loss
Cumulative effect of change
in accounting principle (433)
Issuance of shares 2,860,000 2,860 33,220
Exercise of stock options
and convertible bonds 883,687 883 3,515 334
Compensation costs, stock
options and convertible
bonds 6,938
Balance as of December
31, 2006 33,895,444 33,895 328,171 334
See accompanying notes to unaudited condensed consolidated financial
statements.
Condensed 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, 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, stock
options and convertible bonds 6,665
Balance as of December 31, 2005 (2,093) (229,457) 83,533
Balance as of December 31, 2005 (2,093) (229,457) 83,533
Components of comprehensive loss:
Net loss (64,013) (64,013)
Change in unrealized gain on
available-for-sale securities 615 615
Accumulated translation
adjustments (277) (277)
Total comprehensive loss (63,675)
Cumulative effect of change
in accounting principle (433)
Issuance of shares 36,080
Exercise of stock options and
convertible bonds 4,732
Compensation costs, stock
options and convertible bonds 6,938
Balance as of December 31, 2006 (1,755) (293,470) 67,175
See accompanying notes to unaudited condensed consolidated financial
statements.
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com/
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49 (0)89 8565-2693,
ir@gpc-biotech.com, or Laurie Doyle, Director, Investor Relations
& Corporate Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or In the
U.S.: David Schull of Noonan Russo, +1-212-845-4271,
david.schull@eurorscg.com; or In Europe: Brian Hudspith of
Maitland, +44 (0)20 7379 5151, bhudspith@maitland.co.uk
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