-
Cash, cash equivalents, marketable securities and short-term
investments of € 39.8 million as of
September 30, 2008
-
Company confirms that existing cash position expected to support
currently planned business operations until approximately the end of
2010
GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today
reported financial results for the third quarter and first nine months
ended September 30, 2008.
First nine months of 2008 compared to first nine months of 2007
Revenues decreased 22% to € 12.5 million for
the nine months ended September 30, 2008, compared to €
16.1 million for the same period in 2007. The decrease in revenues is
due to decreased payments from Celgene under the co-development and
license agreement for satraplatin, the termination of which took effect
in September 2008.
Under the termination agreement, Celgene made a one-time payment to GPC
Biotech of approximately € 0.9 million, which
was received in October 2008, related to Celgene’s
portion of the remaining estimated development plan costs for
satraplatin that were not covered by Celgene’s
pre-payments for such costs. In the third quarter of 2008, GPC Biotech
recognized all remaining deferred revenue in the amount of €
8.2 million related to the co-development and license agreement with
Celgene, as well as the € 0.9 million
termination payment.
Research and development (R&D) expenses decreased 68% to €
13.4 million for the first nine months of 2008 compared to €
41.8 million for the same period in 2007. The decrease in R&D expenses
is primarily due to staff reductions as a result of the restructuring
plans implemented in 2007 and the first quarter of 2008, as well as a
decrease in clinical trial costs.
In the first nine months of 2008, general and administrative (G&A)
expenses decreased 69% to € 10.5 million
compared to € 33.6 million for the same
period in 2007. The decrease in G&A expenses is primarily due to staff
reductions and other associated activities as a result of the 2007 and
2008 restructurings. In addition, in the first nine months of 2007, the
Company incurred costs in connection with the building of a commercial
infrastructure and legal fees due to the Spectrum Pharmaceuticals
arbitration proceedings. Net loss for the first nine months of 2008
improved 83% to € (9.9) million compared to €
(57.3) million for the first nine months of 2007. Basic and diluted loss
per share was € (0.27) for the first nine
months of 2008 compared to € (1.59) for the
same period in 2007.
Cash position
As of September 30, 2008, cash, cash equivalents, marketable securities
and short-term investments totaled € 39.8
million (December 31, 2007: € 65.2 million),
including € 1.5 million in restricted cash.
Net cash burn for the first nine months of 2008 was €
24.8 million, with net cash burn of € 10.6
million in the first quarter, € 8.1 million
in the second quarter and € 6.1 in the third
quarter of 2008. Net cash burn, a non-GAAP measure, is derived by adding
net cash used in operating activities and purchases of property,
equipment and licenses. Net cash burn provides insight regarding the
actual cash a company spent in a given period. The figures used to
calculate net cash burn are contained in the Company’s
unaudited consolidated statements of cash flows for the first nine
months ended September 30, 2008.
Comparison to previous year: third quarter 2008
compared to third quarter 2007
Revenues for the three months ended September 30, 2008 increased 6% to €
9.4 million compared to € 8.9 million for the
same period in 2007. R&D expenses decreased 79% for the third quarter of
2008 to € 3.1 million compared to €
14.6 million for the same period in 2007. G&A expenses for the third
quarter of 2008 decreased 77% to € 2.9
million compared to € 12.5 million for the
same quarter in 2007. The Company reported net income of €
3.5 million for the third quarter of 2008 compared to a net loss of €
(18.0) million for the third quarter of 2007, an improvement of 119%.
Basic and diluted earnings per share was €
0.10 for the third quarter of 2008 compared to a loss per share of €
(0.50) for the same period in 2007.
Quarter over quarter results: third quarter 2008
compared to second quarter 2008
Revenues increased 527% to € 9.4
million for the third quarter of 2008 compared to €
1.5 million for the previous quarter. This increase is due to the
recognition of deferred revenue in the third quarter of 2008 in the
amount of € 8.2 million related to the
terminated co-development and license agreement with Celgene, in
addition to the recognition of the termination payment of €
0.9 million. R&D expenses decreased 31% to €
3.1 million for the third quarter of 2008 compared to €
4.5 million in the second quarter of 2008. G&A expenses for the third
quarter of 2008 decreased 28% to € 2.9
million compared to € 4.0 million for the
previous quarter. The Company reported net income of €
3.5 million in the third quarter of 2008, compared to a net loss of €
(6.4) million for the previous quarter, an improvement of 155%. Basic
and diluted earnings per share was € 0.10
for the third quarter of 2008 compared to a loss per share of €
(0.17) for the previous quarter.
“Our major focus continues to be on moving
forward promising M&A opportunities to broaden our pipeline and rebuild
the Company,” said Bernd R. Seizinger, M.D.,
Ph.D., Chief Executive Officer. “We are also
advancing our internal development programs and are particularly pleased
that our multi-targeted kinase inhibitor, RGB-286638, is planned to
shortly enter Phase 1 clinical testing for advanced solid tumors.”
2008 financial guidance
The Company updated its guidance for the full year 2008 as follows:
Revenues: Revenues for 2008 are
expected to be between € 12.5 million and €
13 million, an increase from the guidance provided in August of €
5-7 million. This increase is due to the recognition in the third
quarter of deferred revenue in the amount of €
8.2 million related to the terminated co-development and license
agreement with Celgene, in addition to the recognition of the
termination payment of € 0.9 million.
Expenses: The Company tightened
its guidance for total expenses for 2008, which are expected to be
between € 30 million and €
35 million. The Company previously indicated that expenses for 2008 were
expected to be below € 35 million.
Cash Burn: The Company confirmed
that current cash reserves are expected to be sufficient to fund
currently planned business operations until approximately the end of
2010. The cash burn for 2008 will include several one-time costs,
including severance and other payments related to the 2007 and 2008
corporate restructurings, the majority of which were incurred in the
first half of 2008.
This guidance does not include any potential M&A or other major
transactions, and, should such an event or events occur this year, the
Company’s financial expectations would likely
change significantly.
Conference call scheduled
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 on the Web site following
the live event. The call, which will be conducted in English, will be
held on November 13th at 15:00 CET/9:00 AM ET.
The dial-in numbers for the call are as follows:
|
Participants from Europe:
|
|
0049(0)89 9982 99911
|
|
|
|
0044(0)20 7806 1956
|
|
Participants from the U.S.:
|
|
1-212-444-0413
|
|
|
|
|
|
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
anticancer drugs. GPC Biotech's lead product candidate is satraplatin,
an oral platinum compound. The Company has various anti-cancer programs
in research and development that leverage its expertise in kinase
inhibitors. 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,
including statements about the Company’s
future cash position. 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. We
direct you to GPC Biotech’s Annual Report on
Form 20-F for the fiscal year ended December 31, 2007 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
undertakes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
|
|
|
|
|
|
|
|
|
|
|
GPC Biotech AG
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
in thousand €, except share and per
share data
|
|
2008 (unaudited)
|
|
2007 (unaudited)
|
|
2008 (unaudited)
|
|
2007 (unaudited)
|
|
Collaborative revenues
|
|
9,336
|
|
|
8,848
|
|
|
12,341
|
|
|
15,930
|
|
|
Grant revenues
|
|
42
|
|
|
69
|
|
|
139
|
|
|
213
|
|
|
Total revenues
|
|
9,378
|
|
|
8,917
|
|
|
12,480
|
|
|
16,143
|
|
|
Research and development expenses
|
|
3,128
|
|
|
14,568
|
|
|
13,410
|
|
|
41,782
|
|
|
General and administrative expenses
|
|
2,944
|
|
|
12,453
|
|
|
10,511
|
|
|
33,649
|
|
|
Amortization of intangible assets
|
|
18
|
|
|
19
|
|
|
53
|
|
|
200
|
|
|
Total operating expenses
|
|
6,090
|
|
|
27,040
|
|
|
23,974
|
|
|
75,631
|
|
|
Operating income (loss)
|
|
3,288
|
|
|
(18,123
|
)
|
|
(11,494
|
)
|
|
(59,488
|
)
|
|
Other (expense) income, net
|
|
(135
|
)
|
|
(664
|
)
|
|
224
|
|
|
(575
|
)
|
|
Interest income
|
|
407
|
|
|
785
|
|
|
1,486
|
|
|
2,862
|
|
|
Interest expense
|
|
(22
|
)
|
|
(31
|
)
|
|
(66
|
)
|
|
(98
|
)
|
|
Net income (loss)
|
|
3,538
|
|
|
(18,033
|
)
|
|
(9,850
|
)
|
|
(57,299
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings (loss) per share
|
|
0.10
|
|
|
(0.50
|
)
|
|
(0.27
|
)
|
|
(1.59
|
)
|
|
Shares used in computing basic and diluted loss per share
|
|
36,836,853
|
|
|
36,375,359
|
|
|
36,836,853
|
|
|
35,978,772
|
|
|
See accompanying notes to unaudited condensed consolidated
financial statements.
|
|
|
|
|
|
|
|
GPC Biotech AG
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
in thousand €, except share data and per
share data
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
Assets
|
|
2008 (unaudited)
|
|
2007
|
|
Current assets
|
|
|
|
|
|
Cash and cash equivalents
|
|
38,149
|
|
|
49,681
|
|
|
Marketable securities and short-term investments
|
|
125
|
|
|
14,077
|
|
|
Accounts receivable
|
|
955
|
|
|
984
|
|
|
Prepaid expenses
|
|
645
|
|
|
874
|
|
|
Other current assets
|
|
872
|
|
|
2,229
|
|
|
Restricted Cash
|
|
1,327
|
|
|
1,269
|
|
|
Total current assets
|
|
42,073
|
|
|
69,114
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
1,021
|
|
|
3,070
|
|
|
Intangible assets, net
|
|
111
|
|
|
164
|
|
|
Other assets, non-current
|
|
452
|
|
|
851
|
|
|
Restricted cash
|
|
187
|
|
|
187
|
|
|
Total assets
|
|
43,844
|
|
|
73,386
|
|
|
|
|
|
|
|
|
|
|
Liabilities and shareholders' equity
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
Accounts payable
|
|
421
|
|
|
2,826
|
|
|
Accrued expenses and other current liabilities
|
|
5,318
|
|
|
10,445
|
|
|
Current portion of deferred revenue
|
|
43
|
|
|
4,332
|
|
|
Total current liabilities
|
|
5,782
|
|
|
17,603
|
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion
|
|
7,380
|
|
|
13,989
|
|
|
Convertible bonds
|
|
1,856
|
|
|
3,191
|
|
|
|
|
|
|
|
|
Shareholders' equity
|
|
|
|
|
|
Ordinary shares, € 1 non-par, notional
value:
|
|
|
|
|
|
Shares authorized: 70,383,150 at September 30, 2008 and December 31,
2007
|
|
|
|
|
|
Shares issued and outstanding: 36,836,853 at September 30, 2008
and December 31, 2007
|
|
36,837
|
|
|
36,837
|
|
|
Additional paid-in capital
|
|
369,541
|
|
|
369,521
|
|
|
Accumulated other comprehensive loss
|
|
(4,987
|
)
|
|
(5,040
|
)
|
|
Accumulated deficit
|
|
(372,565
|
)
|
|
(362,715
|
)
|
|
Total shareholders' equity
|
|
28,826
|
|
|
38,603
|
|
|
Total liabilities and shareholders' equity
|
|
43,844
|
|
|
73,386
|
|
|
See accompanying notes to unaudited condensed consolidated
financial statements.
|
|
GPC Biotech AG
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
Nine months ended September 30,
|
|
in thousand €
|
|
2008 (unaudited)
|
|
2007 (unaudited)
|
|
Cash flows from operating activities:
|
|
|
|
|
|
Net loss
|
|
(9,850
|
)
|
|
(57,299
|
)
|
|
Adjustments to reconcile net loss to net cash provided by (used
in) operating activities:
|
|
|
|
|
|
Depreciation
|
|
698
|
|
|
1,284
|
|
|
Amortization
|
|
53
|
|
|
200
|
|
|
(Reversal) expense of Compensation costs for stock option plans,
convertible bonds and SAR's
|
|
(13
|
)
|
|
3,349
|
|
|
Loss accrual on sublease contract and contract termination fee
|
|
110
|
|
|
(381
|
)
|
|
Change in accrued interest income on marketable securities
and short-term investments
|
|
-
|
|
|
(405
|
)
|
|
Other than temporary impairment on marketable securities
|
|
277
|
|
|
-
|
|
|
Bond premium amortization
|
|
19
|
|
|
159
|
|
|
Loss (gain) on disposal of property and equipment
|
|
12
|
|
|
(17
|
)
|
|
Impairment of property and equipment
|
|
16
|
|
|
-
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
Accounts receivable
|
|
167
|
|
|
(2,591
|
)
|
|
Other assets, current and non-current
|
|
1,990
|
|
|
(154
|
)
|
|
Accounts payable
|
|
(2,373
|
)
|
|
(910
|
)
|
|
Deferred revenue
|
|
(10,898
|
)
|
|
2,287
|
|
|
Other liabilities and accrued expenses, current and non-current
|
|
(5,012
|
)
|
|
(2,651
|
)
|
|
Net cash used in operating activities
|
|
(24,804
|
)
|
|
(57,129
|
)
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
Purchases of property, equipment and licenses
|
|
(22
|
)
|
|
(1,479
|
)
|
|
Proceeds from the sale of property and equipment
|
|
1,205
|
|
|
45
|
|
|
Proceeds from the sale or maturity of marketable securities and
short-term investments
|
|
13,830
|
|
|
11,000
|
|
|
Net cash provided by investing activities
|
|
15,013
|
|
|
9,566
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
Proceeds from issuance of shares, net of payments for cost of
transaction
|
|
-
|
|
|
32,633
|
|
|
Proceeds from issuance of convertible bonds
|
|
-
|
|
|
1,006
|
|
|
Repayment of convertible bonds
|
|
(1,455
|
)
|
|
(24
|
)
|
|
Proceeds from exercise of stock options and convertible bonds
|
|
-
|
|
|
5,154
|
|
|
Cash received for subscribed shares
|
|
-
|
|
|
2,080
|
|
|
Net cash (used in) provided by financing activities
|
|
(1,455
|
)
|
|
40,849
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash
|
|
(254
|
)
|
|
(2,229
|
)
|
|
Changes in restricted cash
|
|
(32
|
)
|
|
(52
|
)
|
|
Net decrease in cash and cash equivalents
|
|
(11,532
|
)
|
|
(8,995
|
)
|
|
Cash and cash equivalents at the beginning of the period
|
|
49,681
|
|
|
38,336
|
|
|
Cash and cash equivalents at the end of the period
|
|
38,149
|
|
|
29,341
|
|
|
See accompanying notes to unaudited condensed consolidated
financial statements.
|
|
|
|
GPC Biotech AG
|
|
Consolidated Statements of Changes in Shareholders' Equity
|
|
(in thousand €, except share data)
|
|
|
|
Ordinary shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Subscribed Shares
|
|
Additional Paid-
in Capital
|
|
Accumulated Other
Comprehensive
Loss
|
|
Accumulated Deficit
|
|
Total Shareholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
33,895,444
|
|
33,895
|
|
334
|
|
328,171
|
|
(1,755
|
)
|
|
(293,470
|
)
|
|
67,175
|
|
|
Components of comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
(57,299
|
)
|
|
(57,299
|
)
|
|
Change in unrealized (loss) gain on
available-for-sale securities
|
|
|
|
|
|
|
|
|
|
(129
|
)
|
|
|
|
(129
|
)
|
|
Accumulated translation
adjustments
|
|
|
|
|
|
|
|
|
|
(1,851
|
)
|
|
|
|
(1,851
|
)
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(59,279
|
)
|
|
Issuance of shares
|
|
1,564,587
|
|
1,565
|
|
|
|
31,068
|
|
|
|
|
|
32,633
|
|
|
Exercise of stock options and conversion
of convertible bonds
|
|
1,204,942
|
|
1,205
|
|
1,136
|
|
5,333
|
|
|
|
|
|
7,674
|
|
|
Compensation cost for stock options
and convertible bonds
|
|
|
|
|
|
|
|
3,424
|
|
|
|
|
|
3,424
|
|
|
Balance at September 30, 2007 (unaudited)
|
|
36,664,973
|
|
36,665
|
|
1,470
|
|
367,996
|
|
(3,735
|
)
|
|
(350,769
|
)
|
|
51,627
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
36,836,853
|
|
36,837
|
|
-
|
|
369,521
|
|
(5,040
|
)
|
|
(362,715
|
)
|
|
38,603
|
|
|
Components of comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
(9,850
|
)
|
|
(9,850
|
)
|
|
Change in unrealized gain (loss) on
available-for-sale securities
and other-than-temporary impairment
|
|
|
|
|
|
|
|
|
|
174
|
|
|
|
|
174
|
|
|
Accumulated translation
adjustments
|
|
|
|
|
|
|
|
|
|
(121
|
)
|
|
|
|
(121
|
)
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,797
|
)
|
|
Compensation cost for stock options
and convertible bonds
|
|
|
|
|
|
|
|
20
|
|
|
|
|
|
20
|
|
|
Balance at September 30, 2008 (unaudited)
|
|
36,836,853
|
|
36,837
|
|
-
|
|
369,541
|
|
(4,987
|
)
|
|
(372,565
|
)
|
|
28,826
|
|
GPC Biotech AG
Notes to the Unaudited Condensed Consolidated Financial Statements
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements
of GPC Biotech AG (the “Company”)
have been prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”),
applicable to interim financial reporting, specifically Accounting
Principles Board Opinion No. 28, Interim Financial Reporting, (“APB
28”). These unaudited condensed
consolidated financial statements do not include all information and
disclosures required for a complete set of financial statements.
However, in the opinion of management, all adjustments (consisting of
normal recurring adjustments) considered necessary for a fair
presentation have been included. Operating results for the three month
and nine month period ended September 30, 2008, are not necessarily
indicative of results to be expected for the full year ending December
31, 2008. The balance sheet at December 31, 2007, has been derived from
the audited consolidated financial statements at that date, but does not
include all of the information required by U.S. GAAP for complete
financial statements. For further information, please refer to the
consolidated financial statements and footnotes thereto for the year
ended December 31, 2007.
2. Business Developments
In July 2008, Celgene Corporation withdrew the Marketing Authorization
Application (“MAA”)
for satraplatin plus prednisone for the treatment of hormone-refractory
prostate cancer patients whose prior chemotherapy has failed. Following
the withdrawal of the MAA, in September 2008 Celgene terminated its
co-development and license agreement with GPC Biotech for satraplatin in
Europe, Turkey, the Middle East, Australia and New Zealand. All rights
to these territories were returned to GPC Biotech.
Included in the termination agreement was a one-time termination payment
of approximately € 0.9 million representing
Celgene’s 35% portion of the remaining
estimated development plan costs for satraplatin not covered by the
original prepayment. This payment was received in October 2008. Under
the termination agreement, GPC Biotech was released from all existing
and future obligations to Celgene. Based on the guidance provided by
Staff Accounting Bulletin No. 104, Revenue Recognition, (“SAB
104”), in the third quarter of 2008 GPC
Biotech recognized as revenue, € 9.1 million
including the unamortized portion of the original upfront license fees
of € 7.2 million and €
1.9 million of aggregate prepayments for R&D expenses under the
co-development and license agreement dated December 19, 2005, and the
termination agreement.
At this time, GPC Biotech is completing ongoing satraplatin related
clinical trials and is talking further with Yakult Honsha Co. Ltd. (“Yakult”),
its partner for the development and commercialization of satraplatin for
Japan.
3. New Accounting Pronouncements
Accounting Pronouncements Adopted in the first nine months of 2008
In September 2006, the Financial Accounting Standards Board (“FASB”)
issued Statement of Financial Accounting Standards No. 157, Fair
Value Measurements, (“SFAS 157”).
SFAS 157 defines fair value, establishes a framework for measuring fair
value in GAAP and expands disclosures about fair value measurements. In
February 2007, the FASB issued Statement of Financial Accounting
Standards No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, (“SFAS 159”).
SFAS 159 permits entities to choose to measure many financial
instruments and certain items at fair value that are not currently
required to be measured at fair value. The Company adopted these two
standards as of January 1, 2008. SFAS 157 affected the Company only to
the extent of its marketable securities and short-term investments
carried on a recurring basis at fair value using quoted prices in active
markets for identical assets, which is the Level 1 input in the SFAS 157
hierarchy. As of September 30, 2008, the fair value of marketable
securities and short-term investments amounted to €
0.1 million as included in the consolidated balance sheet. The Company
did not elect to measure other financial instruments and certain items
at fair value that were not currently required to be measured at fair
value. Therefore, the adoption of SFAS 159 did not have a material
impact on its consolidated financial statements.
On June 14, 2007, the FASB ratified Emerging Issues Task Force 07-3, Accounting
for Non-Refundable Advance Payments for Goods or Services to Be Used in
Future Research and Development Activities, (“EITF
07-3”). EITF 07-3 requires that all
non-refundable advance payments for research and development activities
that will be used in future periods be capitalized until used. In
addition, the deferred research and development costs need to be
assessed for recoverability. EITF 07-3 is applicable for fiscal years
beginning after December 15, 2007, and is to be applied prospectively
for new contracts entered into on or after the effective date of this
Issue. The Company adopted this issue as of January 1, 2008, and it did
not have a material impact on its consolidated financial statements.
Accounting Pronouncements Not Yet Adopted
On December 12, 2007, the FASB ratified Emerging Issues Task Force 07-1,
Accounting for Collaborative Arrangements, (“EITF
07-1”). EITF 07-1 requires participants in a
collaborative arrangement to present the results of activities for which
they act as the principal on a gross basis and to report any payments
received from (made to) other collaborators based on other applicable
GAAP or, in the absence of other applicable GAAP, based on analogy to
authoritative or a reasonable, rational, and consistently applied
accounting policy election. Significant disclosures of the collaborative
agreements are also required. EITF 07-1 will be effective for annual
periods beginning after December 15, 2008, and is to be applied
retrospectively for collaborative arrangements existing at December 15,
2008, as a change of accounting principle. The Company does not expect
EITF 07-1 to have a material effect on its consolidated financial
statements.
On May 22, 2008, the FASB issued Statement on Financial Accounting
Standards No. 162, The Hierarchy of Generally Accepted Accounting
Principles, (“SFAS 162”).
SFAS 162 identifies the sources of accounting principles and the
framework for selecting the principles to be used in the preparation of
financial statements of non-governmental entities that are presented in
conformity with U.S. GAAP (the GAAP hierarchy). The effective date of
SFAS 162 has yet to be determined; it becomes effective for both SEC
registrants and nonpublic entities 60 days after the SEC approves the
PCAOB’s amendments to AU Section 411, The
Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles, of the AICPA Professional Standards, the
codified version of Statements of Accounting Standards No. 69, The
Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles in the Independent Auditor’s
Report, (“SAS 69”).
The Company does not expect this statement to have a material effect on
its consolidated financial statements.
During its June 2008 meeting, the FASB ratified EITF 07-5, Determining
Whether an Instrument (or an Embedded Feature) Is Indexed to an Entity's
Own Stock, (“EITF 07-5”).
EITF 07-5 addresses the determination of whether an instrument (or an
embedded feature) is indexed to an entity's own stock, which is the
first part of the scope exception in paragraph 11(a) of Statement of
Financial Accounting Standards No. 133, Accounting for Derivative
Instruments and Hedging Activities, (“FAS
133”). If an instrument (or an embedded
feature) that has the characteristics of a derivative instrument under
paragraphs 6–9 of FAS 133 is indexed to an
entity's own stock, it is still necessary to evaluate whether it is
classified in stockholders' equity (or would be classified in
stockholders' equity if it were a freestanding instrument). For example,
a net-cash-settled stock purchase warrant may be indexed to an entity's
own stock, but it is not classified in stockholders' equity. Other
applicable authoritative accounting literature, including Emerging
Issues Task Force No. 00-19, Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company's Own Stock,
(“EITF 00-19”) and
Emerging Issues Task Force No. 05-2, Meaning of "Conventional
Convertible Debt Instrument" in Issue No. 00-19, (“EITF
05-2”), provide guidance for determining
whether an instrument (or an embedded feature) is classified in
stockholders' equity (or would be classified in stockholders' equity if
it were a freestanding instrument). EITF 07-5 does not address the
second part of the scope exception in paragraph 11(a) of FAS 133. No
transition is required with respect to the evaluation of contingent
exercise provisions because the Task Force affirmed the existing
consensus in Emerging Issues Task Force No. 01-6, The Meaning of
"Indexed to a Company's Own Stock", (“EITF
01-6”). However, when evaluating a settlement
amount to determine whether an instrument or embedded feature is indexed
to an entity's own stock, the FASB staff recommends that a consensus be
effective for financial statements issued for fiscal years beginning
after December 15, 2008, and interim periods within those fiscal years.
Early application is not permitted. The guidance in EITF 07-5 shall be
applied to outstanding instruments as of the beginning of the fiscal
year in which the EITF 07-5 is initially applied. The Company is
evaluating the impact of EITF 07-5 on its consolidated financial
statements.
4. Contingencies
From time to time, the Company may be party to certain legal proceedings
and claims which arise during the ordinary course of business. Legal
proceedings are subject to various uncertainties and the outcomes are
difficult to predict. GPC Biotech may incur significant expense in
defending these and future lawsuits. In the opinion of management, the
ultimate outcome of these matters will not have material adverse effects
on the Company’s financial position, results
of operations or cash flows. In accordance with Statement of Financial
Accounting Standards No. 5, Accounting for Contingencies, (“SFAS
5”), the Company makes a provision for a
liability when it is both probable that a liability has been incurred
and when the amount of the loss is reasonably estimable.
Shareholder Litigation
In July 2007, the Company and certain of its current and former officers
were sued in the United States District Court for the Southern District
of New York in three separate securities fraud class action lawsuits on
behalf of all persons who purchased the securities of GPC Biotech
between December 5, 2005 and July 24, 2007, inclusive. The suits have
since been consolidated and a lead plaintiff has been appointed. The
lead plaintiff's consolidated complaint was filed on March 12, 2008. The
consolidated complaint alleges that GPC Biotech violated U.S. federal
securities laws by making misleading public statements relating to the
prospects of its most advanced product candidate, satraplatin, and
thereby artificially inflating the price of GPC Biotech securities. The
consolidated complaint also names Bernd R. Seizinger (CEO) and three
former members of the Company's Management Board, Mirko Scherer, Elmar
Maier, and Sebastian Meier-Ewert, as defendants. The Company filed a
motion to dismiss the consolidated complaint on May 14, 2008 and the
plaintiff filed an opposition to said motion on June 30, 2008. The
Company filed a reply to the opposition on August 8, 2008.
The plaintiffs seek monetary damages in an unspecified amount. GPC
Biotech believes the allegations to be without merit and intends to
vigorously defend the Company. GPC Biotech cannot predict the outcome of
the suit and is not currently able to estimate the possible cost to the
Company from this suit.
Retention Plan
In 2008, the Company introduced a plan to retain key employees. This
retention plan consists of a total cash bonus of approximately €
405,000 to certain employees who continue to be employed through March
2009, which is payable in the first quarter of 2009 and is being
recognized ratably over the future service period; and 906,000 stock
options based on existing stock option plans, which are being accounted
for in accordance with Statements of Financial Accounting Standards No.
123R, Share-Based Payment, (“SFAS
123(R)”).
5. Earnings (Loss) per Share
Basic earnings (loss) per ordinary share is computed using the weighted
average number of ordinary shares outstanding during the period. Diluted
net earnings (loss) per ordinary share is computed using the weighted
average number of ordinary and dilutive ordinary equivalent shares from
stock options and convertible bonds where the dilutive effect of options
and warrants was calculated using the treasury stock method. For all
periods presented, diluted net earnings (loss) per share is the same as
basic net earnings (loss) per share, as the inclusion of weighted
average shares of ordinary stock issuable upon the exercise of stock
options and convertible bonds would be antidilutive.
6. Comprehensive Loss
Comprehensive loss was € 9.8 million and € 59.3
million for the nine months ended September 30, 2008 and 2007,
respectively. Comprehensive loss is composed of net loss, unrealized
gains and losses on available-for-sale securities and cumulative foreign
currency translation adjustments. Accumulated other comprehensive loss
on September 30, 2008, reflected less than € 0.1
million of unrealized gains on marketable securities and short-term
investments and € 5.0 million of cumulative
foreign currency translation loss adjustments.
During the quarter ended June 30, 2008, a loss was recognized in the
statement of operations for available-for-sale marketable equity
securities that were deemed to be other-than-temporarily impaired at
June 30, 2008. Accordingly, included in other income (expense) net, on
the statement of operations for the nine months ended September 30,
2008, is a loss in the amount of approximately €
277,000 that was reclassified out of other comprehensive loss and into
the statement of operations during the second quarter.
7. Additional Disclosures
Convertible Bonds
Convertible bonds for the nine months ended September 30, 2008,
decreased 35.3% to € 2.2 million compared to €
3.4 million as of December 31, 2007. The decrease in convertible bonds
is primarily due to the Company’s repayment
of convertible bonds as a result of the restructuring plans implemented
in 2007 and the first quarter of 2008; as described in detail in Note 10
of the consolidated financial statements as of December 31, 2007, and
below. As of September 30, 2008 and December 31, 2007, approximately €
0.3 million of convertible bonds are in other current liabilities due to
planned repayment of these bonds.
Revenue
Revenues for the nine months ended September 30, 2008, decreased 22.4%
to € 12.5 million compared to €
16.1 million for the same period in 2007. The decrease in revenues is
due to decreased payments from Celgene under the co-development and
license agreement for satraplatin and was partially offset by the
recognition of € 9.1 million of unamortized
fees recognized during the quarter ended September 30, 2008, when the
obligations under that agreement were terminated (refer to Note 2).
Research and Development Expense
Research and development (“R&D”)
expenses for the nine months ended September 30, 2008, decreased 67.9%
to € 13.4 million compared to €
41.8 million for the same period in 2007. The decrease in R&D expenses
is primarily due to staff reductions as a result of the restructuring
plans implemented in 2007 and the first quarter of 2008, as well as a
decrease in clinical trial costs due to reduced clinical trial volumes.
Restructuring plans are described in detail in Note 10 of the
consolidated financial statements as of December 31, 2007, and below.
General and Administrative Expenses
General and administrative (“G&A”)
expenses for the nine months ended September 30, 2008, decreased 68.8%
to € 10.5 million compared to €
33.6 million for the same period in 2007. The decrease in G&A expenses
is primarily due to staff reductions and other associated activities as
a result of the restructuring plans implemented in 2007 and the first
quarter of 2008. In addition, in the first nine months of 2007, the
Company incurred costs in connection with the building of a commercial
infrastructure and also incurred legal fees due to the Spectrum
Pharmaceuticals arbitration proceedings. The Company did not incur such
costs in the first nine months of 2008. Restructuring plans are
described in detail in Note 10 of the consolidated financial statements
as of December 31, 2007, and below.
Share-Based Compensation
For the nine months ended September 30, 2008 and 2007, the Company
recorded a credit to share-based compensation cost of €
13,000 and incurred € 3.3 million in costs,
respectively. The 2008 credit is the result of the termination of stock
options and convertible bonds relating to the restructuring plans
implemented during 2007 and the first quarter of 2008. Upon termination,
compensation expense for awards for which the requisite service period
has not been rendered is reversed.
Product Candidate Licensing Activities
As discussed in Note 4 of the consolidated financial statements as of
December 31, 2007, in June 2007 the Company entered into a license
agreement with Yakult for the development and commercialization of
satraplatin in Japan. The upfront license payment of €
7.4 million was included in deferred revenue, non-current, as of
September 30, 2008 and December 31, 2007, as the Company was not able to
estimate the period of substantial involvement as of these balance sheet
dates. The Company will continue to defer the revenue until the timing
of the satraplatin development plan, which approximates the period of
substantial involvement, can be reliably determined.
Restructuring Activities
In February 2008, the Company announced a corporate restructuring to
sharpen its focus on oncology clinical development and to further reduce
costs. The restructuring was mainly focused on the Company’s
early-stage research activities in Munich and resulted in a reduction in
the total workforce of approximately 38% or 38 employees. The Company
has recognized a restructuring charge of €
2.1 million through the nine months ended September 30, 2008, relating
to this activity. These charges primarily consist of employee severance
and termination benefits and are included in both research and
development and general and administrative expenses. The Company does
not expect to incur any additional material charges relating to the
February 2008 restructuring plan. In addition, the Company has recorded
a change in estimate reducing its 2007 and 2008 restructuring accruals
by € 247,000 due to employee terminations
that occurred earlier than initially determined.
Also, in February 2008 Elmar Maier, Ph.D., Chief Operating
Officer/Martinsried and Senior Vice President, Business Development, and
Sebastian Meier-Ewert, Ph.D., Senior Vice President and Chief Scientific
Officer retired from their positions on the Management Board of the
Company by mutual consent, to allow for an appropriate resizing of the
Management Board, given the reduced size of the Company. Both Dr. Maier
and Dr. Meier-Ewert remain dedicated to the Company as advisors. The
restructuring charge of € 2.1 million
mentioned above includes the severance for these former Management Board
members, which was paid in April 2008.
A summary of the significant components of the restructuring liability
at September 30, 2008, is as follows (in thousand €):
|
|
|
Employee
|
|
Lease
|
|
|
|
|
|
Termination
|
|
Termination
|
|
|
|
|
|
Benefits
|
|
Costs
|
|
Total
|
|
|
|
|
|
|
|
|
|
January 1, 2008 Balance
|
|
2,327
|
|
|
2,214
|
|
|
4,541
|
|
|
|
|
|
|
|
|
|
|
Amortization of Lease Loss
|
|
-
|
|
|
(165
|
)
|
|
(165
|
)
|
|
|
|
|
|
|
|
|
|
Restructuring Charges
|
|
1,993
|
|
|
110
|
|
|
2,103
|
|
|
|
|
|
|
|
|
|
|
Restructuring Payments
|
|
(3,664
|
)
|
|
(1,801
|
)
|
|
(5,465
|
)
|
|
|
|
|
|
|
|
|
|
Adjustments / Changes in estimates
|
|
(247
|
)
|
|
-
|
|
|
(247
|
)
|
|
|
|
|
|
|
|
|
|
Exchange Differences
|
|
89
|
|
|
(71
|
)
|
|
18
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 Balance
|
|
498
|
|
|
287
|
|
|
785
|
|
A restructuring liability of € 0.8 million
and € 4.5 million as of September 30, 2008
and December 31, 2007, respectively, is included in accrued expenses and
other current liabilities in the accompanying condensed consolidated
balance sheets. For further information, please refer to Note 10 of the
consolidated financial statements and footnotes thereto for the year
ended December 31, 2007.
Disposal of Property and Equipment
During the first nine months of 2008 the Company sold some of its assets
(mainly laboratory equipment and office furniture), a majority of which
had been impaired in 2007 and related to the Munich facility. These
assets had a historical cost of approximately €
3.0 million and a net book value of approximately €
1.4 million. The Company has recorded a loss of approximately €
12,000 relating to the sale of these assets.
8. Disclosures Required by the Frankfurt Stock Exchange
Number of Employees
As of September 30, 2008 and 2007, the number of employees totalled 68
and 248, respectively.
Shareholdings of Management
As of September 30, 2008, the members of the Management Board and the
Supervisory Board held shares, stock options, convertible bonds and
stock appreciation rights in the amounts set forth in the table below:
|
|
|
Number of
Shares
|
|
Number of
Stock
Options
|
|
Number of
Convertible
Bonds
|
|
Number of
Stock
Appreciation
Rights
|
|
Management Board
|
|
|
|
|
|
|
|
|
|
Bernd R. Seizinger, M.D., Ph.D. (Chairman)
|
|
111,499
|
|
789,000
|
|
1,413,501
|
|
-
|
|
Torsten Hombeck, Ph. D.
|
|
-
|
|
172,700
|
|
45,000
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Supervisory Board
|
|
|
|
|
|
|
|
|
|
Jürgen Drews, M.D. (Chairman)
|
|
26,900
|
|
10,000
|
|
-
|
|
80,000
|
|
Michael Lytton (Vice Chairman)
|
|
7,500
|
|
10,000
|
|
-
|
|
60,000
|
|
Metin Colpan, Ph.D.
|
|
19,400
|
|
10,000
|
|
-
|
|
45,000
|
|
James Frates
|
|
1,000
|
|
-
|
|
-
|
|
60,000
|
|
Peter Preuss
|
|
87,500
|
|
-
|
|
-
|
|
50,000
|
|
Donald Soltysiak
|
|
-
|
|
-
|
|
-
|
|
10,000
|
GPC Biotech AG
Investor Relations & Corporate Communications
+49
(0)89 8565-2693
ir@gpc-biotech.com
or
In
the U.S.:
Laurie Doyle, +1-609-524-5884
Director, Investor
Relations & Corporate Communications
usinvestors@gpc-biotech.com
or
Additional
media contacts for Europe:
MC Services AG
Raimund Gabriel
raimund.gabriel@mc-services.eu
Hilda
Juhasz
hilda.juhasz@mc-services.eu
+49
(0) 89 210 228 0
or
Additional investor contact for Europe:
Trout
International LLC
Lauren Rigg, +44 207 936 9325
Vice President
lrigg@troutgroup.com