GPCB Gpc Biotech AG ADS (MM)

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 OF THE

SECURITIES EXCHANGE ACT OF 1934

 

November 2008

 

Commission File Number: 000-50825

 

 

 

GPC BIOTECH AG

(Exact name of registrant as specified in its Charter)

 

 

 

Fraunhoferstrasse 20

D-82152 Martinsried/Munich, Germany

Tel: 011 49 89 8565 2600

(Address of registrant’s principal executive offices)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

				Form 20-F       X		Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

				Yes		No       X

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

				Yes		No       X

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

				Yes		No       X

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- N/A

 

 

 

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INDEX

 

Exhibit 99.1		GPC Biotech Reports Financial Results for Third Quarter and First Nine Months of 2008 (U.S. GAAP)

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E XHIBIT 99.1

 

 

P RESS R ELEASE

 

F OR I MMEDIATE R ELEASE

 

GPC Biotech Reports Financial Results

 

for Third Quarter and First Nine Months of 2008

 

•

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

 

Martinsried/Munich (Germany) and Princeton, N.J., November 13, 2008 - 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

 

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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

 

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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

 

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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 13 ^th 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.

 

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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

 

– Financials follow –

 

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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.

 

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GPC Biotech AG

Condensed Consolidated Balance Sheets

 

		September 30,			December 31,
in thousand €, except share data and per share data		2008 (unaudited)			2007
Assets
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.

 

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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.

 

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GPC Biotech AG

Consolidated Statements of Changes in Shareholders’ Equity

(in thousand €, except share data)

 

		Ordinary shares				Subscribed Shares		Additional Paid-in Capital		Accumulated Other Comprehensive Loss			Accumulated Deficit			Total Shareholders’ Equity
		Shares		Amount
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

 

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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.

 

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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

 

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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

 

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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.

 

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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.

 

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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.

 

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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.

 

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A summary of the significant components of the restructuring liability at September 30, 2008, is as follows (in thousand €):

 

		Employee Termination Benefits			Lease Termination 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.

 

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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

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.

 

Date: November 19, 2008