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
August 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 Second Quarter of 2008 issued by GPC Biotech AG (IFRS)
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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 25, 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- June 2008
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C
ONTENTS
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Interim management report
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Interim condensed consolidated financial statements (IFRS)
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Page 1 of 16
Interim management report
Business performance
Year-to-date performance
Revenues decreased 58% to 3.0 million for the six months ended June 30, 2008, compared to 7.1 million for the same period in 2007. The decrease in revenues is due to decreased payments
from Celgene Corporation relating to the ongoing trials under the co-development and license agreement for satraplatin. Research and development (R&D) expenses decreased 62% to 10.3 million for the first six months of 2008 compared
to 27.2 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 well as a decrease in
clinical trial costs due to reduced clinical trial volumes. In the first half of 2008, general and administrative (G&A) expenses decreased 65% to 7.4 million compared to 21.1 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 half of 2007, the Company incurred
costs in connection with the building of a commercial infrastructure and legal fees due to the arbitration proceedings. The Company did not incur such costs in the first half of 2008. Net loss for the first six months of 2008 improved 60% to
(15.8) million compared to (39.4) million for the first six months of 2007. Basic and diluted loss per share was (0.43) for the first six months of 2008 compared to (1.10) for the same period in 2007.
Quarterly performance
Revenues for the three
months ended June 30, 2008 decreased 55% to 1.5 million compared to 3.3 million for the same period in 2007. R&D expenses decreased 70% for the second quarter of 2008 to 4.5 million compared to
15.0 million for the same period in 2007. Administrative expenses for the second quarter of 2008 decreased 65% to 3.9 million compared to 11.3 million for the same quarter in 2007. Net loss for the second quarter of 2008
decreased 61% to (8.7) million compared to (22.2) million for the second quarter of 2007. Basic and diluted loss per share was (0.24) for the second quarter of 2008 compared to (0.62) for the same period in
2007.
Financial position
As of June 30, 2008,
cash, cash equivalents, and available-for-sale investments totaled 44.6 million (December 31, 2007: 65.2 million), including 1.4 million in restricted cash. Net cash burn for the first six months of 2008 was
18.7 million, with net cash burn of 10.6 million in the first quarter and 8.1 million in the second quarter of 2008. 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 six-month period ended June 30, 2008.
Page 2 of 16
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 (HRPC), 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. Several clinical trials evaluating satraplatin in combination
with various anti-cancer treatments are ongoing. Data from some of these studies, including the overall survival results from the SPARC trial, were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2008.
In late July 2008, Celgene withdrew the Marketing Authorization Application (MAA) for satraplatin plus prednisone for the treatment of hormone-refractory
prostate cancer patients whose prior chemotherapy has failed. Celgenes decision was based on a list of outstanding issues received following review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMEA) of the filing, which indicated that the opinion of the Committee was that the application was currently not approvable based on the information provided.
Following the withdrawal of the MAA in August 2008, GPC Biotech received notice from Celgene of its decision to terminate its co-development and license agreement with GPC Biotech for satraplatin. All rights to Celgenes territories
will be returned to GPC Biotech.
Yakult Honsha Co., Ltd (Yakult) is the Companys partner for the development and commercialization of
satraplatin in Japan. GPC Biotech plans to talk further with Yakult to evaluate the future of satraplatin and the direction in which the Company should move with this compound.
Two kinase inhibitor compounds in pre-clinical development
Pre-clinical work for the most advanced of the
Companys kinase inhibitors, RGB-286638 (638), 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 638 results in tumor regression and increases survival time. The first Phase 1 trial with 638 is expected to be
initiated in solid tumors in Europe. A second Phase 1 trial in hematological tumors is being planned in the U.S.
A second drug candidate, RGB-344064, is
undergoing the necessary pre-clinical testing to move this compound into the clinic. Based on pre-clinical testing, this compound is expected to be orally administered.
Page 3 of 16
The Company is also actively pursuing potential merger and acquisition (M&A), in part to fill its oncology
development pipeline.
Restructuring
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 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 2.0 million in the first half 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 0.1 million in 2008 relating to the February 2008 restructuring plan. In addition, the
Company recorded an adjustment reducing its 2007 restructuring accrual by 161,000 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 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 2.0 million during the first half of 2008, as mentioned above, is the accrual relating to severance for these former Management Board members which was paid in April 2008.
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 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.
Page 4 of 16
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).
After the withdrawal of the
MAA for satraplatin in Europe and after Celgene provided notice of termination of its Collaboration and License Agreement with GPC Biotech, the Companys medium to long-term success depends largely on its ability to expand its pipeline through
M&A activities or other major transactions that allow the Company to acquire promising product candidates. If GPC Biotech is unable to enter into a transaction within the next 12 months or execute a transaction thereafter, the Companys
ability to raise additional funds beyond its existing cash based on the programs currently in its pipeline will likely be extremely limited.
The Company
can not accurately predict when or whether it will successfully complete the development of its product candidates or the ultimate product development cost.
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 is highly focused on pursuing
potential merger and acquisition (M&A) to fill its oncology development pipeline. The timing and structure of such transactions cannot be determined, and there can be no guarantee that any transactions will be completed in a timely manner, if at
all. The following outlook does not take into account such potential transactions, which would likely have a significant impact on the Companys financials.
Page 5 of 16
Financials
The Company confirmed its guidance provided in May 2008 as follows:
Revenues:
Revenues for 2008 are expected to be between
5 million and 7 million. Once the termination of the co-development and license agreement between GPC Biotech and Celgene Corporation for satraplatin for Europe and certain other territories is effective, GPC Biotech expects to recognize
all or the majority of remaining deferred revenue related to the agreement. This deferred revenue is related to cash already received by GPC Biotech under this agreement. The Company will update revenue guidance as appropriate.
Expenses:
Total expenses for 2008 are expected to be below 35 million.
Cash Burn:
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 corporate restructurings in 2007 and early 2008. The majority of these onetime costs were already incurred in the first half of 2008.
Key activities
The pursuit of potential M&A transactions
is the top priority for the Company as such activities would enable GPC Biotech to broaden its development pipeline. In addition, GPC Biotech plans to talk further with Yakult, its partner for the development and commercialization of satraplatin for
Japan, to evaluate the future of satraplatin and the direction in which the Company should move with this compound. The kinase inhibitor, RGB-286638, is expected to enter Phase 1 clinical testing during 2008. The Company is working to move another
kinase inhibitor product candidate, RGB-344064, through pre-clinical testing.
Page 6 of 16
GPC Biotech AG
Interim consolidated statement of operations
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Three months ended June 30
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Six months ended June 30
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2008 (unaudited)
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2007 (unaudited)
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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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000
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000
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Revenue
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1,491
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3,320
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3,005
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7,082
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Research and development expenses
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(4,533
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(14,964
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(10,282
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(27,169
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Administrative expenses
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(3,886
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)
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(11,340
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(7,388
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(21,060
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)
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Amortization of intangible assets
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(49
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(142
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(114
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(299
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)
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Impairment of intangible assets
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(2,306
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(2,306
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Other income, net
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124
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(87
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455
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102
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Finance income
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474
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1,049
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1,079
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2,077
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Finance costs
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(27
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(76
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(216
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(134
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Net loss for the period
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(8,712
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(22,240
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)
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(15,767
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)
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(39,401
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Income taxes
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Net loss for the period
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(8,712
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(22,240
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(15,767
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(39,401
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Basic and diluted loss per share
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(0.24
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(0.62
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(0.43
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(1.10
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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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36,106,533
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36,836,853
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35,776,752
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See accompanying notes to unaudited interim condensed consolidated financial statements
Page 7 of 16
GPC Biotech AG
Interim consolidated balance sheet
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June 30,
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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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1,689
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2,401
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Intangible assets
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3,667
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6,105
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Other financial assets
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940
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1,038
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Total non-current assets
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6,296
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9,544
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Current assets
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Trade receivables
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348
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984
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Prepayments
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899
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874
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Other current assets
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3,010
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3,498
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Available-for-sale investments
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113
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14,077
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Cash and cash equivalents
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43,117
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49,681
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Total current assets
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47,487
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69,114
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Total Assets
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53,783
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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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368,794
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369,267
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Other reserves
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(4,889
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)
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(4,320
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)
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Retained loss
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(373,432
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)
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(357,665
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)
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Total equity
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27,310
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44,119
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Non-current liabilities
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Convertible bonds
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1,985
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2,824
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Deferred revenue, net of current portion
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12,004
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13,989
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Total non-current liabilities
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13,989
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16,813
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Current liabilities
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Trade payables
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2,368
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2,826
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Accruals and other current liabilities
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6,306
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|
10,568
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Deferred revenue, current portion
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3,810
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4,332
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Total current liabilities
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12,484
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17,726
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Total liabilities
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26,473
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34,539
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Total equity and liabilities
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53,783
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78,658
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See accompanying notes to unaudited interim condensed consolidated financial statements
Page 8 of 16
GPC Biotech AG
Interim consolidated cash flow statement
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Six months ended June 30
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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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Net loss for the period
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(15,767
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)
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(39,401
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)
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Adjustments for:
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Depreciation
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442
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|
745
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Amortization
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114
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298
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Loss (adjustment to loss) accrual on sublease contract
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|
110
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(100
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)
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Compensation costs/ (reversal) for share-based payments
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(463
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)
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2,205
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Amortization of premium of marketable securities
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19
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|
|
105
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|
Impairment of short-term investments
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277
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|
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Impairment of property, equipment and intangible assets
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|
2,322
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|
|
|
|
Accrued investment income from available-for-sale investments
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|
|
|
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(351
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)
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Finance income
|
|
(1,079
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)
|
|
(2,077
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)
|
Finance costs
|
|
216
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|
|
134
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|
Gain from the sale of property and equipment
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|
(281
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)
|
|
(43
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)
|
|
|
|
|
|
|
|
|
|
(14,090
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)
|
|
(38,485
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)
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Decrease in other assets, non-current and current
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|
920
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|
|
1,287
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|
Decrease (increase) in trade receivables
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|
636
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|
|
(10,655
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)
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(Decrease) increase in trade payables
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|
(373
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)
|
|
1,473
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|
(Decrease) increase in deferred revenues
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|
(2,507
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)
|
|
4,574
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|
(Decrease) increase in accruals and other liabilities
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|
(3,900
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)
|
|
3,135
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|
|
|
|
|
|
|
|
Cash used in operating activities
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|
(19,300
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)
|
|
(38,671
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)
|
|
|
|
|
|
|
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Interest received
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|
571
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|
|
907
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|
Interest paid
|
|
(1
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)
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|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
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|
(18,730
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)
|
|
(37,764
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|
|
|
|
|
|
|
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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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|
(15
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)
|
|
(4,198
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)
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Proceeds from sale of property and equipment and intangible assets
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|
509
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|
|
45
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|
Proceeds from sale of available-for-sale investments
|
|
13,830
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|
|
11,000
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
14,324
|
|
|
6,847
|
|
|
|
|
|
|
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
Proceeds from issue of share capital, net of payments for transaction costs
|
|
|
|
|
32,633
|
|
Proceeds from exercise of share options and convertible bonds
|
|
|
|
|
5,384
|
|
Proceeds from issue of convertible bonds
|
|
|
|
|
345
|
|
Repayment of convertible bonds
|
|
(1,250
|
)
|
|
(24
|
)
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
(1,250
|
)
|
|
38,338
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
(885
|
)
|
|
(783
|
)
|
Changes in restricted cash
|
|
(23
|
)
|
|
(35
|
)
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
(6,564
|
)
|
|
6,603
|
|
Cash and cash equivalents at beginning of period
|
|
49,681
|
|
|
38,336
|
|
|
|
|
|
|
|
|
Cash and cash equivalent at end of period
|
|
43,117
|
|
|
44,939
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited interim condensed consolidated financial statements
Page 9 of 16
GPC Biotech AG
Interim consolidated statement of changes in shareholders equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 six-month period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net gains on available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
146
|
|
|
|
|
|
146
|
|
Exchange differences on translating foreign operations
|
|
|
|
|
|
|
|
|
|
|
(641
|
)
|
|
|
|
|
(641
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss recognized directly in equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(495
|
)
|
Net loss for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(39,401
|
)
|
|
(39,401
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total recognized income and expense for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(39,896
|
)
|
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
|
|
793,022
|
|
793
|
|
3,725
|
|
|
1,195
|
|
|
|
|
|
|
|
5,713
|
|
Compensation cost from share-based payment
|
|
|
|
|
|
1,788
|
|
|
|
|
|
|
|
|
|
|
1,788
|
|
Equity component convertible bonds
|
|
|
|
|
|
|
|
|
|
|
63
|
|
|
|
|
|
63
|
|
Balance at June 30, 2007 (unaudited)
|
|
36,253,053
|
|
36,253
|
|
364,684
|
|
|
1,529
|
|
(1,654
|
)
|
|
(323,471
|
)
|
|
77,341
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2008
|
|
36,836,853
|
|
36,837
|
|
369,267
|
|
|
|
|
(4,320
|
)
|
|
(357,665
|
)
|
|
44,119
|
|
|
|
|
|
|
|
|
|
Changes in equity for the six-month period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss on available-for-sale Investments and impairment
|
|
|
|
|
|
|
|
|
|
|
162
|
|
|
|
|
|
162
|
|
Exchange differences on translating foreign operations
|
|
|
|
|
|
|
|
|
|
|
(731
|
)
|
|
|
|
|
(731
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss recognized directly in equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(569
|
)
|
Net loss for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,767
|
)
|
|
(15,767
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total recognized income and expense for the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,336
|
)
|
Compensation cost from share-based payment
|
|
|
|
|
|
(473
|
)
|
|
|
|
|
|
|
|
|
|
(473
|
)
|
Balance at June 30, 2008 (unaudited)
|
|
36,836,853
|
|
36,837
|
|
368,794
|
|
|
|
|
(4,889
|
)
|
|
(373,432
|
)
|
|
27,310
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited interim condensed consolidated financial statements
Page 10 of 16
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 six months ended June 30, 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
, (APB 28). 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. 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 August 2008, GPC Biotech received notice from Celgene of its decision to terminate 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 will be returned to GPC Biotech. The effects of this decision on the
Companys financial position and results of operations will be determined and reflected in the consolidated financial statements when the termination has become effective.
At this time, all currently ongoing trials with satraplatin are continuing. The Company plans to talk further with Yakult, its partner for the development and commercialization of satraplatin for Japan, to evaluate
the future of satraplatin and the direction in which the Company should move with the compound.
Page 11 of 16
3. 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 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 2.0 million during the first half 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 0.1 million in 2008 relating to the February 2008
restructuring plan. In addition, the Company recorded an adjustment reducing its 2007 restructuring accrual, which was for restructuring plans implemented in the second half of 2007, by 161,000 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 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 2.0 million during the first half of 2008, as mentioned above, is the
accrual relating to severance for these former Management Board members, which was paid in April 2008.
A summary of the significant components of the
restructuring liability at June 30, 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
|
|
|
|
|
(209
|
)
|
|
(209
|
)
|
Restructuring Charges
|
|
1,851
|
|
|
110
|
|
|
1,961
|
|
Restructuring Payments
|
|
(3,348
|
)
|
|
(1,349
|
)
|
|
(4,697
|
)
|
Adjustments/Changes in estimates
|
|
(161
|
)
|
|
|
|
|
(161
|
)
|
Exchange Differences
|
|
301
|
|
|
(248
|
)
|
|
53
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 Balance
|
|
970
|
|
|
642
|
|
|
1,612
|
|
|
|
|
|
|
|
|
|
|
|
Page 12 of 16
A restructuring liability of 1.6 million and 4.7 million as of June 30, 2008 and
December 31, 2007, respectively, is included in accruals and other current liabilities in the accompanying condensed consolidated balance sheets.
4. 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 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 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 retention plan to retain key employees. This retention plan consists of a cash bonus of
approximately 440,000, which is payable in the first quarter of 2009, to certain employees who continue to be employed through March 2009 and is being recognized ratably over the future service period; and 906,000 stock options which are being
accounted for in accordance with IFRS 2.
5. Shareholders Equity
As of June 30, 2008, GPC Biotech had conditional capital to potentially issue additional shares of the Company 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, GPC Biotech had authorized capital to potentially issue additional shares of the Company in the amount of 16.2
million. As of June 30, 2007, conditional and authorized capital amounted to 12.8 million and 16.7 million, respectively.
No
stock options or convertible bonds were exercised or converted for the six months ended June 30, 2008.
Page 13 of 16
6. Additional Disclosures
Convertible bonds
Convertible bonds for the six months ended June 30, 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 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 6 of the consolidated financial statements as of December 31, 2007 and Note 3 above. As of June 30, 2008, and December 31, 2007, approximately 0.2 million of convertible bonds are in
other current liabilities due to planned repayment of these bonds.
Revenue
Revenues decreased 58% to 3.0 million for the six months ended June 30, 2008, compared to 7.1 million for the same period in 2007. The decrease in revenues is due to decreased payments
from Celgene relating to the on-going trials under the co-development and license agreement for satraplatin.
Research and development expenses
Research and development (R&D) expenses for the six months ended June 30, 2008, decreased 62% to 10.3 million compared to
27.2 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 half 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 6 of the consolidated financial statements as of December 31, 2007 and Note 3 above.
Administrative expenses
Administrative expenses for the six months
ended June 30, 2008, decreased 65% to 7.4 million compared to 21.1 million for the same period in 2007. The decrease in administrative 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 half of 2007, the Company incurred costs in connection with the building of a commercial infrastructure and legal fees due to the
arbitration proceedings. The Company did not incur such costs in the first half of 2008. Restructuring plans are described in detail in Note 6 to the consolidated financial statements as of December 31, 2007 and Note 3 above.
Share-based compensation
For the six months ended June 30, 2008
and 2007, the Company recorded a credit to share-based compensation cost of (0.5) million and incurred 2.2 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.
Page 14 of 16
Product candidate licensing activities
As discussed in Note 8 to the consolidated financial statements as of December 31, 2007, in June 2007, the Company entered into a license agreement with Yakult Honsha Co. Ltd. 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 June 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.
Impairment of intangible assets
In 2007 the Company
capitalized a milestone payment of 2.3 million paid upon filing of the first satraplatin MAA with the EMEA. Due to the subsequent withdrawal of the MAA, the Company de-recognized the capitalized milestone associated with the MAA
acceptance and recorded an impairment loss of 2.3 million during the first half of 2008. See Note 2 for further details.
Impairment of
short term investments
During the three months 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. Accordingly, an accumulated loss in the amount of approximately 277,000 was reclassified out of Other Reserves into Other Income (Expense), Net, on the
statement of operations.
Gain on disposal of property and equipment
During the first half of 2008 the Company sold some of its assets (mainly laboratory equipment and office furniture), the majority of which had been impaired in 2007, at both the Princeton and Munich facilities. These
assets had a historical cost of approximately 1.6 million and a net book value of approximately 0.3 million. The Company recorded a gain of approximately 0.3 million relating to the sale of these assets.
7. Disclosures Required by the Frankfurt Stock Exchange
Number of employees
As of June 30, 2008 and 2007, the number of employees totalled 86 and 286, respectively.
Page 15 of 16
Shareholdings of management
As of June 30, 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
|
|
|
|
80,000
|
Michael Lytton (Vice Chairman)
|
|
7,500
|
|
10,000
|
|
|
|
60,000
|
Metin Colpan, Ph.D.
|
|
19,400
|
|
10,000
|
|
|
|
45,000
|
Donald Soltysiak
|
|
|
|
|
|
|
|
10,000
|
James Frates
|
|
1,000
|
|
|
|
|
|
60,000
|
Peter Preuss
|
|
87,500
|
|
|
|
|
|
50,000
|
Page 16 of 16
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