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
May 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 registrants 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
INDEX
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Exhibit 99.1
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Interim management report and interim condensed consolidated financial statements for the First Quarter of 2008 issued by GPC Biotech AG
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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: August 13, 2008
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GPC BIOTECH AG
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By:
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/s/ Bernd Seizinger
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Name:
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Bernd Seizinger, M.D., Ph.D.
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Title:
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CEO
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By:
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/s/ Torsten Hombeck
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Name:
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Torsten Hombeck, Ph.D.
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Title:
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Vice President and CFO
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E
XHIBIT
99.1
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GPC Biotech AG:
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Interim Report
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January- March 2008
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C
ONTENTS
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Interim management report
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Interim condensed consolidated financial statements
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Page 1 of 18
Interim management report
Business performance and financial position
Revenues decreased 60% to 1.5 million for the first quarter of 2008, compared to 3.8 million for the first quarter of 2007. The decrease in
revenues is primarily due to a decline in payments received under the co-development and license agreement for satraplatin with Celgene Corporation (formerly Pharmion Corporation) as the SPARC Phase 3 trial has been mostly completed. Research and
development (R&D) expenses decreased 53% to 5.7 million for the first three months of 2008 compared to 12.2 million for the same period in 2007. In the first quarter of 2008, administrative expenses decreased
64% to 3.5 million compared to 9.7 million for the first quarter of 2007. The decrease in R&D and administrative expenses is primarily due to staff reductions and other associated activities as a result of the
restructuring plans announced in the second half of 2007 and in the first quarter of 2008 to sharpen the Companys focus on oncology clinical development efforts and to further reduce costs. Net loss for the first quarter of 2008 improved 59%
to (7.0) million compared to (17.2) million for the first quarter of 2007. Basic and diluted loss per share was (0.19) for the first quarter of 2008 compared to (0.48) for the same quarter in 2007.
As of March 31, 2008, cash, cash equivalents, and available-for-sale
investments totaled 53.5 million (December 31, 2007: 65.2 million), including 1.4 million in restricted cash. Net cash burn for the first quarter of 2008 was 10.6 million. Net cash burn is derived by adding
net cash used in operating activities and purchases of property, equipment and licenses. The figures used to calculate net cash burn are contained in the Companys interim consolidated cash flow statement for the three months ended
March 31, 2008.
Research and development
GPC Biotech currently is focusing its internal research and development efforts on three
anti-cancer programs.
Satraplatin, an oral platinum compound
In the Fall of 2007, GPC Biotech reported that the Phase 3 trial in
second-line hormone-refractory prostate cancer, the SPARC trial, did not achieve the overall survival endpoint, although data presented previously did show a statistically significant improvement in the progression-free survival endpoint. The
Company has since stopped several trials with satraplatin, continued others and is evaluating initiating new trials. Data from several satraplatin clinical trials, including the overall survival results from the SPARC trial, are being presented at
the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in June.
Page 2 of 18
In addition, a Marketing Authorization Application (MAA) for satraplatin in Europe for the treatment of
hormone-refractory prostate cancer patients whose prior chemotherapy has failed remains active. The European regulatory process is being managed by Celgene Corporation, the Companys partner for the development and commercialization of
satraplatin for Europe and certain other territories. GPC Biotech is supporting Celgene in this process.
Yakult Honsha Co., Ltd (Yakult) is the Companys partner for the development and commercialization of satraplatin in Japan. Yakult has evaluated several potential development strategies that could
lead to a registration for satraplatin in that territory. The Company expects that a specific plan will be advanced during 2008 and plans to work closely with Yakult as they implement their strategy.
Two kinase inhibitor compounds in pre-clinical development
Pre-clinical work for the most advanced of these compounds, RGB-286638, has been completed,
and the Company expects to begin Phase 1 clinical testing during 2008. Testing in cancer cells has shown that RGB-286638 leads to cell cycle inhibition and induces apoptosis (programmed cell death), key elements in stopping the spread of cancer
cells. Compelling data in animal tumor models show that use of RGB-286638 results in tumor regression and increases survival time. A second drug candidate, RGB-344064, is undergoing the necessary pre-clinical testing to move this compound into the
clinic.
The Company is also actively pursuing potential merger and acquisition
(M&A), as well as possible in-licensing opportunities in part to fill its oncology development pipeline.
Restructuring
In February 2008, the
Company announced a corporate restructuring plan to sharpen its focus on oncology clinical development and to further reduce costs. The restructuring was mainly focused on the Companys early-stage research activities in Munich and resulted in
a reduction in the total workforce of approximately 38% or 38 employees. The Company recognized a restructuring charge of 1.7 million during the first quarter of 2008. These charges primarily consisted of employee severance and
termination benefits and were included in both R&D and administrative expenses. The Company expects to incur an additional charge of 0.3 million in 2008 relating to the February 2008 restructuring plan.
In addition, the Company announced that, by mutual consent, 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 to allow for an
appropriate resizing of the Board, given the reduced size of the Company. Both Dr. Maier and Dr. Meier-Ewert remain dedicated to the Company as advisors.
Page 3 of 18
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 plaintiffs 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 Companys
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. The plaintiff has the opportunity to file an opposition to the motion to
dismiss on or before June 30, 2008. If the plaintiff files such an opposition, the Company will then have the opportunity to reply thereto on or before 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.
Risks and opportunities
The Companys activities, especially in the area of drug development, expose it to many risks that are inherent to the industry and stage of the Companys
products and operations. GPC Biotechs business opportunities and risk management allow the Company to identify such risks in advance, analyze them, and plan for the Companys success. Information on the Companys opportunities and
risk management system and the risk position of the Company can be found in the Consolidated Financial Statements (IFRS) and Group Management Report dated December 31, 2007 (2007 Annual Report).
An MAA for satraplatin in Europe remains active, and the European regulatory process is being
managed by Celgene. A decision on the filing is expected in the second half of 2008. The Company cannot provide any assurances that satraplatin will be approved for marketing in Europe. The Company also cannot accurately predict when or whether it
will successfully complete the development of its product candidates or the ultimate product development cost.
In conclusion, GPC Biotechs overall risk exposure described above and in the 2007 Annual Report is typical for a publicly traded biotechnology company focused on drug development.
Page 4 of 18
Outlook
This section contains forward-looking statements which express the current beliefs and expectations of the management of GPC Biotech. Such statements are subject to risks
and uncertainties. Actual results could differ materially, depending on a number of factors, including the timing and effects of regulatory actions, the results of clinical trials, the Companys relative success in developing and gaining market
acceptance for any new products, and the effectiveness of patent protection.
This section should be read in conjunction with the outlook presented in our Annual Report for the year ended December 31, 2007.
The Company expects revenues to decline in 2008 compared to 2007. A decision on the MAA for satraplatin in Europe is expected in the second half of 2008. If the decision
were favorable, GPC Biotech would receive a milestone payment from Celgene (net of a licensing fee that would be paid to Spectrum Pharmaceuticals, Inc.) of approximately 10.5 million. The Company may enter into additional partnerships.
However, the timing and likelihood of such agreements is highly unpredictable.
For 2008, the Company expects R&D expenses to be lower than 2007. Headcount has been reduced significantly and the Phase 3 satraplatin SPARC trial has been mostly completed. However, the Company will continue to incur certain costs
related to ongoing management and eventual completion of the SPARC and other satraplatin clinical trials. The Company will carefully consider additional financial commitments before new satraplatin trials are opened. GPC Biotech is obligated to pay
to Spectrum Pharmaceuticals milestone payments for certain regulatory and commercialization achievements, as well as a certain percentage of milestone payments the Company receives under any sublicense agreements for satraplatin, such as the
agreements with Pharmion and Yakult. The RGB-286638 compound is expected to enter Phase 1 clinical testing during 2008. Administrative expenses are expected to decrease significantly during 2008 as the Company has sharply reduced its headcount.
Net income will be impacted by the developments described above.
Current cash, cash equivalents, restricted cash and available-for-sale investments of
53.5 million is expected to be sufficient to support currently planned business operations until approximately the end of 2010.
During 2008 and 2009, GPC Biotech plans to focus on advancing its current research and development programs and broadening its clinical development pipeline through
potential M&A and possibly in-licensing opportunities. Results from several clinical trials involving satraplatin are to be presented at ASCO Annual Meeting in June 2008. A decision on the satraplatin MAA in Europe is expected in the second half
of 2008.
Page 5 of 18
The Company expects to move RGB-286638 into the clinic during 2008 and is working to move another kinase inhibitor
product candidate, RGB-344064, through pre-clinical testing.
Page 6 of 18
GPC Biotech AG
Interim consolidated statement of operations
for the three months ended March 31, 2008
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Three months ended March 31
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In thousand , except share data and per share data
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2008 (unaudited)
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2007 (unaudited)
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Revenue
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1,514
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3,762
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Research and development expenses
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(5,749
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)
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(12,205
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Administrative expenses
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(3,502
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(9,720
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Amortization of intangible assets
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(65
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(157
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Other income, net
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331
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189
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Finance income
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605
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1,028
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Finance costs
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(189
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(58
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Net loss before tax
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(7,055
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)
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(17,161
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)
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Net loss for the period
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(7,055
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)
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(17,161
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)
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Basic and diluted loss per share
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(0.19
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(0.48
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)
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Average number of shares used in computing basic and diluted loss per share
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36,836,853
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35,441,336
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See accompanying notes to unaudited
interim condensed consolidated financial statements.
Page 7 of 18
GPC Biotech AG
Interim consolidated balance sheet as of March 31, 2008
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March 31,
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December 31,
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2008 (unaudited)
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2007
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000
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000
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Assets
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Non-current assets
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Property and equipment
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2,100
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2,401
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Intangible assets
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6,023
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6,105
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Other financial assets
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913
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1,038
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Total non-current assets
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9,036
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9,544
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Current assets
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Trade receivables
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458
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984
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Prepayments
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649
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874
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Other current assets
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3,244
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3,498
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Available-for-sale investments
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4,038
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14,077
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Cash and cash equivalents
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48,083
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49,681
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Total current assets
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56,472
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69,114
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Total Assets
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65,508
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78,658
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Equity and Liabilities
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Equity attributable to the Companys equity holders
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Issued capital
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36,837
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36,837
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Share premium
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368,346
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369,267
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Other reserves
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(4,969
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)
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(4,320
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)
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Retained loss
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(364,720
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)
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(357,665
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)
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Total equity
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35,494
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44,119
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Non-current liabilities
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Convertible bonds
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1,973
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2,824
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Deferred revenue, net of current portion
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13,089
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13,989
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Total non-current liabilities
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15,062
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16,813
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Current liabilities
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Trade payables
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1,694
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|
|
2,826
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Accruals and other current liabilities
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|
9,264
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|
|
10,568
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Deferred revenue, current portion
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3,994
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4,332
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|
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Total current liabilities
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14,952
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17,726
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Total liabilities
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30,014
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34,539
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Total equity and liabilities
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65,508
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78,658
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|
|
|
|
|
|
|
|
See accompanying notes to unaudited
interim condensed consolidated financial statements.
Page 8 of 18
GPC Biotech AG
Interim consolidated cash flow statement
for the three months ended March 31, 2008
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Three months ended March 31
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2008 (unaudited)
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2007 (unaudited)
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000
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|
000
|
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Cash flows from operating activities
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|
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Net loss for the period
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(7,055
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)
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(17,161
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)
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Adjustments for:
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Depreciation
|
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227
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|
|
356
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|
Amortization
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65
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|
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157
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Compensation costs/ reversal for share-based payments
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(921
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)
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494
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Amortization of premium of marketable securities
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17
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52
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Impairment of property and equipment
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17
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Accrued investment income from available-for-sale investments
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(157
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)
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Finance income
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(605
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)
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(1,028
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)
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Finance costs
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189
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|
58
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|
Gain from the sale of property and equipment
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(305
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)
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(43
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)
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(8,371
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)
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(17,272
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)
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Decrease in other assets, non-current and current
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894
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|
441
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|
Decrease (increase) in trade receivables
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642
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|
|
(1,925
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)
|
Decrease in trade payables
|
|
(1,056
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)
|
|
(93
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)
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Decrease in deferred revenues
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|
(1,238
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)
|
|
(1,143
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)
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(Decrease) increase in accruals and other liabilities
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|
(1,583
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)
|
|
790
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|
|
|
|
|
|
|
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Cash used from operations
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(10,712
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)
|
|
(19,202
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)
|
|
|
|
|
|
|
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Interest received
|
|
153
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|
|
502
|
|
|
|
|
|
|
|
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Net cash used in operating activities
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|
(10,559
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)
|
|
(18,700
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)
|
|
|
|
|
|
|
|
Cash flows from investing activities
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|
|
|
|
|
|
Purchase of property and equipment and intangible assets
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|
(1
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)
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(657
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)
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Proceeds from sale of property and equipment and intangible assets
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|
207
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|
|
45
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|
Proceeds from sale of available-for-sale investments
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10,000
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|
|
11,000
|
|
|
|
|
|
|
|
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Net cash provided by investing activities
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|
10,206
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|
|
10,388
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|
|
|
|
|
|
|
|
Page 9 of 18
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Cash flows from financing activities
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|
|
|
|
Proceeds from issue of share capital, net of payments for transaction costs
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|
|
|
|
32,632
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|
Proceeds from exercise of share options and convertible bonds
|
|
|
|
|
2,473
|
|
Proceeds from issue of convertible bonds
|
|
|
|
|
262
|
|
Repayment of convertible bonds
|
|
(445
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)
|
|
(4
|
)
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
(445
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)
|
|
35,363
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
(786
|
)
|
|
(467
|
)
|
Changes in restricted cash
|
|
(14
|
)
|
|
(17
|
)
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
(1,598
|
)
|
|
26,567
|
|
Cash and cash equivalents at beginning of period
|
|
49,681
|
|
|
38,336
|
|
|
|
|
|
|
|
|
Cash and cash equivalent at end of period
|
|
48,083
|
|
|
64,903
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited
interim condensed consolidated financial statements.
Page 10 of 18
GPC Biotech
Interim consolidated statement of changes in shareholders
equity for the three months ended March 31, 2008
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
Issued
capital
|
|
Share
premium
|
|
|
Subscribed
shares
|
|
Other
Reserves
|
|
|
Retained
loss
|
|
|
Total
equity
|
|
in 000, excluding number of shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2007
|
|
33,895,444
|
|
33,895
|
|
328,103
|
|
|
334
|
|
(1,222
|
)
|
|
(284,070
|
)
|
|
77,040
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in equity for the three-month period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net gains on available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
72
|
|
|
|
|
|
72
|
|
Exchange differences on translating foreign operations
|
|
|
|
|
|
|
|
|
|
|
(429
|
)
|
|
|
|
|
(429
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss recognized directly in equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(357
|
)
|
Net loss for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,161
|
)
|
|
(17,161
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total recognized income and expense for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,518
|
)
|
Issue of share capital - equity offering
|
|
1,564,587
|
|
1,565
|
|
32,074
|
|
|
|
|
|
|
|
|
|
|
33,639
|
|
Transaction cost
|
|
|
|
|
|
(1,006
|
)
|
|
|
|
|
|
|
|
|
|
(1,006
|
)
|
Exercise of share options and convertible bonds
|
|
488,417
|
|
488
|
|
1,842
|
|
|
330
|
|
|
|
|
|
|
|
2,660
|
|
Compensation cost from share-based payment
|
|
|
|
|
|
274
|
|
|
|
|
|
|
|
|
|
|
274
|
|
Equity component convertible bonds
|
|
|
|
|
|
|
|
|
|
|
54
|
|
|
|
|
|
54
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2007 (unaudited)
|
|
35,948,448
|
|
35,948
|
|
361,287
|
|
|
664
|
|
(1,525
|
)
|
|
(301,231
|
)
|
|
95,143
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2008
|
|
36,836,853
|
|
36,837
|
|
369,267
|
|
|
|
|
(4,320
|
)
|
|
(357,665
|
)
|
|
44,119
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in equity for the three-month period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net losses on available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
(22
|
)
|
|
|
|
|
(22
|
)
|
Exchange differences on translating foreign operations
|
|
|
|
|
|
|
|
|
|
|
(627
|
)
|
|
|
|
|
(627
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) recognized directly in equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(649
|
)
|
Net loss for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,055
|
)
|
|
(7,055
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total recognized income and expense for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,704
|
)
|
Compensation cost from share-based payment
|
|
|
|
|
|
(921
|
)
|
|
|
|
|
|
|
|
|
|
(921
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2008 (unaudited)
|
|
36,836,853
|
|
36,837
|
|
368,346
|
|
|
|
|
(4,969
|
)
|
|
(364,720
|
)
|
|
35,494
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited
interim condensed consolidated financial statements.
Page 11 of 18
GPC Biotech AG
Notes to the unaudited interim condensed consolidated financial statements
1. Basis of Presentation and Accounting Policies
Basis of presentation
The accompanying interim condensed consolidated financial statements of GPC Biotech AG (the Company) for the three months ended
March 31, 2008 have been prepared in accordance with IAS 34,
Interim Financial Reporting (IAS 34)
. The interim condensed consolidated financial statements do not include all the information and disclosures required in the
annual financial statements prepared in accordance with International Financial Reporting Standards (IFRS), and should be read in conjunction with the Companys annual financial statements for the year ended December 31, 2007.
Accounting policies
The accounting policies adopted and valuation methods applied in the preparation of the
interim condensed consolidated financial statements are consistent with those followed in the preparation of the Companys annual consolidated financial statements for the year ended December 31, 2007.
The Company also prepares interim condensed consolidated financial statements in accordance
with the 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
. Such interim
condensed consolidated financial statements prepared in accordance with U.S. GAAP applicable to interim financial reporting differ in certain aspects from these interim condensed consolidated financial statements prepared in accordance with IAS 34.
2. Restructuring Activities
In February 2008, the Company announced a corporate restructuring plan to sharpen its focus
on oncology clinical development and to further reduce costs. The restructuring was mainly focused on the Companys early-stage research activities in Munich and resulted in a reduction in the total workforce of approximately 38% or 38
employees. The Company recognized a restructuring charge of 1.7 million during the first quarter of 2008. These charges primarily consisted of employee severance and termination benefits and were included in both research and development
and administrative expenses. The Company expects to incur an additional charge of 0.3 million in 2008 relating to the February 2008 restructuring plan.
In addition, the Company announced that, by mutual consent, 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
Page 12 of 18
the Company to allow for an appropriate resizing of the Board, given the reduced size of the Company. Both Dr. Maier and Dr. Meier-Ewert remain
dedicated to the Company as advisors. Included in the restructuring charge of 1.7 million during the first quarter of 2008, as mentioned above, is the accrual relating to severance for these former Board members which was paid in April
2008.
A summary of the significant components of the restructuring liability
at March 31, 2008, are as follows (in thousand ):
|
|
|
|
|
|
|
|
|
|
|
|
Employee
Termination
Benefits
|
|
|
Lease
Termination
Costs
|
|
|
Total
|
|
January 1, 2008 Balance
|
|
2,327
|
|
|
2,338
|
|
|
4,665
|
|
Amortization of Lease Loss
|
|
|
|
|
(121
|
)
|
|
(121
|
)
|
Restructuring Charges
|
|
1,673
|
|
|
|
|
|
1,673
|
|
Restructuring Payments
|
|
(1,762
|
)
|
|
(682
|
)
|
|
(2,444
|
)
|
Exchange Differences
|
|
(96
|
)
|
|
(148
|
)
|
|
(244
|
)
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 Balance
|
|
2,142
|
|
|
1,387
|
|
|
3,529
|
|
|
|
|
|
|
|
|
|
|
|
A restructuring liability of
3.5 million and 4.7 million as of March 31, 2008 and December 31, 2007, respectively, is included in accruals and other current liabilities in the accompanying consolidated balance sheets.
3. Contingencies
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
Page 13 of 18
securities. The consolidated complaint also names Bernd R. Seizinger (CEO) and three former members of the Companys 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. The plaintiff has the opportunity to file an opposition to the motion to dismiss on or before June 30,
2008. If the plaintiff files such an opposition, the Company will then have the opportunity to reply thereto on or before 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.
Contingencies related to the approval of the Marketing Authorization Application (MAA) for satraplatin in second-line HRPC by the European Medicines Agency
(EMEA)
The Company has contingent commitments related to
payments pending on the marketing approval of satraplatin by the EMEA. As of March 31, 2008, for accounting purposes, the Company assessed the probability of these contingent liabilities relating to the approval of satraplatin in second-line
HRPC in Europe. Due to uncertainties in the regulatory approval process of satraplatin, the Company assessed the probability of these contingent liabilities as less than probable.
Under the Companys agreement with Spectrum Pharmaceuticals, Inc. (Spectrum), GPC Biotech is obligated to make a milestone
payment in the amount of $3.0 million or approximately 1.9 million to Spectrum, which is contingent upon the approval of the MAA by the EMEA.
In addition, the Company has a cash bonus plan to retain the Companys employees and if EMEA approval is obtained, the total payout under this plan may lead to an
increase in personnel expense of up to 235,000.
The Company also issued
stock appreciation rights (SARs) to senior management, the members of the Supervisory Board, and certain employees. These SARs would entitle the holder to cash payments if the performance condition were to be met. Please refer to Note 30 to the
consolidated financial statements as of December 31, 2007 and the year then ended, for a description of SARs performance conditions. No new SARs were issued during the first quarter of 2008. Due to uncertainties in the approval process of
satraplatin, there were no liabilities and expenses recognized as of March 31, 2008, with respect to such contingent payments triggered by the approval of satraplatin by the EMEA.
Contingent gain
The Company is entitled to receive a milestone payment from Celgene Corporation (net of licensing fee paid to Spectrum) of approximately 10.5 million upon the
approval of the MAA for satraplatin with the EMEA. Gross receipt will be recognized as revenue upon milestone achievement.
Page 14 of 18
4. Shareholders Equity
As of March 31, 2008, the Company had conditional capital in the amount of 17.4 million, with 3.2 million
thereof accounting for conditional capital available pursuant to Section 192(2)(3) of the German Stock Corporation Act (AktG). In addition, the Company had authorized capital in the amount of 16.2 million. As of March 31, 2007,
conditional and authorized capital amounted to 11.7 million and 14.7 million, respectively.
No stock options or convertible bonds were exercised for the three months ended March 31, 2008.
5. Additional Disclosures
Convertible bonds
Convertible bonds for the three months ended March 31, 2008, decreased 27% to 2.2 million compared to
3.0 million as of December 31, 2007. The decrease in convertible bonds is primarily due to the Companys cancellation 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 6 to the consolidated financial statements as of December 31, 2007 and for the year then ended, and Note 2 above. As of March 31, 2008 and December 31, 2007, approximately 0.2 million of
convertible bonds are in other current liabilities due to the cancellation of these bonds.
Revenue
Revenues for the three months
ended March 31, 2008 decreased 60% to 1.5 million compared to 3.8 million for the same period in 2007. The decrease in revenues is due to decreased payments from Celgene relating to the co-development and license
agreement for satraplatin as the SPARC Phase 3 trial was mostly completed in 2007.
Research and development expenses
Research and development
(R&D) expenses for the three months ended March 31, 2008, decreased 53% to 5.7 million compared to 12.2 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 described in detail in Note 6 to the consolidated financial statements as of December 31, 2007 and for the year then ended, and Note 2 above.
Administrative expenses
Administrative expenses for the three months ended March 31, 2008, decreased 64% to 3.5 million compared to
9.7 million for the same period in 2007. The decrease in administrative expenses is primarily
Page 15 of 18
due to staff reductions and other associated activities as a result of the restructuring plans implemented in 2007 and the first quarter of 2008; as
described in detail in the Note 6 to the consolidated financial statements as of December 31, 2007 and for the year then ended, and Note 2 above.
Share-based compensation
For the three months March 31, 2008 and 2007, the Company recorded a credit to share-based compensation cost of (0.9) million and incurred
0.5 million in costs, respectively. This decrease 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 in which the requisite service period has not been rendered is reversed.
Product candidate licensing activities
As disclosed in Note 8 to the consolidated financial statements as of December 31, 2007 and for the year then ended, in June 2007, the Company entered into a license agreement with Yakult Honsha Co. Ltd. for development and
commercialization of satraplatin in Japan. The upfront license payment of 7.4 million was included in deferred revenue, non-current, as of March 31, 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.
Gain on disposal of property and equipment
During the first quarter of 2008, the Company sold some of its assets (mainly laboratory
equipment and office furniture) at both the Princeton and Munich facilities. These assets had a historical cost of approximately 0.4 million and a net book value of approximately less than 0.1 million. The Company recorded a gain
of approximately 0.3 million relating to the sale of these assets.
6. Disclosures Required by the Frankfurt Stock Exchange
Number of employees
As of
March 31, 2008 and 2007, the number of employees totalled 106 and 261, respectively.
Page 16 of 18
Shareholdings of management
As of March 31, 2008, the members of the Management Board and 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
|
|
12,500
|
|
80,000
|
Michael Lytton (Vice Chairman)
|
|
7,500
|
|
10,000
|
|
31,500
|
|
60,000
|
Metin Colpan, Ph.D.
|
|
19,400
|
|
10,000
|
|
10,000
|
|
45,000
|
Donald Soltysiak
|
|
|
|
|
|
|
|
10,000
|
James Frates
|
|
1,000
|
|
|
|
|
|
60,000
|
Peter Preuss
|
|
87,500
|
|
|
|
22,500
|
|
50,000
|
Page 17 of 18
Responsibility Statement
To the best of managements knowledge and in accordance with the applicable reporting principles for interim financial reporting, the interim condensed
consolidated financial statements give a true and fair view of the assets, liabilities, financial position and profit of the Company, and the interim management report of the Company includes a fair review of the development and performance of the
business and the position of the Company, together with a description of the principal opportunities and risks associated with the expected development of the Company for the remaining months of the financial year.
Page 18 of 18
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