MARTINSRIED/MUNICH, GERMANY and PRINCETON, NJ--(Marketwire - May 28, 2009) - GPC Biotech AG (FRANKFURT: GPC) (XETRA: GPC) today reported financial results for the first quarter and three months ended March 31, 2009.
First quarter 2009 compared to first quarter 2008
The Company had no revenues in the first quarter of 2009, compared to EUR 1.5 million for the first quarter of 2008. The decrease in revenues is due to the termination of the co-development and license agreement for satraplatin with Celgene Corporation in September 2008. Research and development (R&D) expenses decreased 74% to EUR 1.5 million for the first three months of 2009 compared to EUR 5.7 million for the same period in 2008. The decrease in R&D expenses is primarily due to staff reductions as a result of the restructuring plan implemented in 2008, a decrease in clinical trial costs and a credit to share-based compensation expense due to the cancellation of stock options and convertible bonds. In the first quarter of 2009, administrative expenses were EUR 3.5 million compared to EUR 3.5 million for the first quarter of 2008. Net loss for the first quarter of 2009 improved 39% to EUR (4.3) million compared to EUR (7.1) million for the first quarter of 2008. Basic and diluted loss per share was EUR (0.12) for the first quarter of 2009 compared to EUR (0.19) for the same quarter in 2008.
As of March 31, 2009, cash, cash equivalents and available-for-sale investments totaled EUR 11.6 million (December 31, 2008: EUR 32.0 million), including EUR 0.2 million in restricted cash, which is under Other Financial Assets on the balance sheet. As previously announced, in February 2009, in connection with the proposed business combination with Agennix Incorporated, the Company made a loan to Agennix in the amount of $20 million (EUR 15.7 million) in the form of a senior secured convertible promissory note. The proceeds of this loan are being used to support the clinical development of talactoferrin prior to the closing of the transaction. Net cash burn for the first quarter of 2009 was EUR 4.9 million. Net cash burn is derived by adding net cash used in operating activities and purchases of property, equipment and intangible assets. The figures used to calculate net cash burn are contained in the Company’s unaudited interim consolidated cash flow statement for the first quarter ended March 31, 2009.
Quarter over quarter results: first quarter 2009 compared to fourth quarter 2008
For the first quarter of 2009, the Company had no revenues, compared to EUR 31,000 for the previous quarter. R&D expenses decreased 56% to EUR 1.5 million for the first quarter of 2009 compared to EUR 3.4 million for the fourth quarter of 2008. Administrative expenses for the first quarter of 2009 decreased 29% to EUR 3.5 million compared to EUR 4.9 million for the previous quarter. The Company’s net loss was EUR (4.3) million in the first quarter of 2009 compared to EUR (9.0) million for the previous quarter. Basic and diluted loss per share was EUR (0.12) for the first quarter of 2009 compared to EUR (0.25) for the previous quarter.
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: “We are very excited about the proposed combination with Agennix and look forward to our shareholders voting on the proposed merger agreement at our annual shareholders’ meeting on June 23.”
Year-to-date highlights
To date in 2009, the Company has had the following key achievements:
- Business Combination Agreement was signed, under which the Company proposes to combine businesses with U.S. biotechnology company, Agennix, Incorporated, in a new German company. Agennix has an oncology program, talactoferrin, currently in two Phase 3 clinical trials for non-small cell lung cancer. Dievini Hopp BioTech holding GmbH & Co. KG is investing EUR 15 million in the new company.
- New data on satraplatin from the SPARC Phase 3 trial in second-line castrate- or hormone-refractory prostate cancer were presented at the American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium. The data showed an improvement in overall survival in a subset of patients refractory to docetaxel (Taxotere®).
- New pre-clinical data on RGB-286638 multi-targeted kinase inhibitor were presented at the American Association for Cancer Research (AACR) Annual Meeting. The data showed that RGB-286638 demonstrates in vivo activity in several pre-clinical models of multiple myeloma. The compound has also been shown to induce cell death in multiple myeloma cells independent from the p53 status; p53 is a gene involved in the control of cell proliferation. New data in solid tumor cells were also presented.
Financial guidance
GPC Biotech continues to expect that the average annual cash burn of the combined entity will be approximately EUR 30 million for 2009 and for 2010. This amount excludes one-time total transaction-related costs of approximately EUR 7 million, which includes banking and legal fees associated with the merger for GPC Biotech, Agennix and the new entity, as well as fees for the listing of the new entity on the Frankfurt Stock Exchange. GPC Biotech expects that the existing cash of GPC Biotech and Agennix, plus the cash contribution of dievini Hopp BioTech holding as part of the proposed merger, will be sufficient to fund operations of the combined entity into the second quarter of 2010. GPC Biotech believes that it should have sufficient cash as a stand-alone entity to close the proposed merger, depending on the actual closing date. If the merger is not completed in a timely manner or at all, the ability of GPC Biotech to continue as a going concern on a stand-alone basis will be at risk.
Conference call scheduled
As previously announced, the Company has scheduled a conference call to which participants may listen via live webcast, accessible through the GPC Biotech Web site at www.gpc-biotech.com or via telephone. A replay will be available via the Web site following the live event. The call, which will be conducted in English, will be held on May 28 at 15:00 CET/9:00 AM ET. The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0)69 667775756 or 0044 (0)20 3003 2666
Participants from the U.S.: 1-646-843-4608
Please dial in 10 minutes before the beginning of the meeting.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on developing anti-cancer drugs. The Company currently has two programs in clinical development: satraplatin, an oral platinum compound and RGB-286638, a multi-targeted protein kinase inhibitor. On February 18, 2009, the Company announced plans to combine its business with U.S.-based Agennix, Incorporated in a new German company. Agennix, a privately held biotechnology company, is developing oral talactoferrin, a product candidate that is currently in Phase 3 trials for non-small cell lung cancer. GPC Biotech AG is headquartered in Martinsried/Munich (Germany) and has a wholly owned U.S. subsidiary in Princeton, New Jersey. For additional information, please visit GPC Biotech’s Web site at www.gpc-biotech.com.
This press release contains forward-looking statements which express the current beliefs and expectations of the management of GPC Biotech. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. There can be no guarantee that the proposed merger will be approved by GPC Biotech shareholders or will close in a timely manner, if at all. Forward-looking statements speak only as of the date on which they are made and GPC Biotech undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Taxotere® is a registered trademark of Aventis Pharma S.A.
GPC Biotech AG Interim consolidated statement of operations for the three months ended March 31, 2009 Three months ended March 31 2009 2008 Notes (unaudited) (unaudited) In thousand EUR, except share data and per share data Revenue 6 - 1,514 Research and development expenses 6 (1,537) (5,749) Administrative expenses (3,518) (3,502) Amortization of intangible assets (45) (65) Impairment of intangible assets (407) - Other income, net 985 331 Finance income 275 605 Finance costs (29) (189) ------------ ------------ Net loss before tax (4,276) (7,055) ------------ ------------ Net loss for the period (4,276) (7,055) ============ ============ Basic and diluted loss per share (EUR 0.12) (EUR 0.19) Average number of shares used in computing basic and diluted loss per share 36,836,853 36,836,853 See accompanying notes to unaudited interim condensed consolidated financial statements GPC Biotech AG Interim consolidated statement of comprehensive income (loss) for the three months ended March 31, 2009 Three months ended March 31 2009 2008 (unaudited) (unaudited) in EUR 000 Net loss (4,276) (7,055) Other comprehensive income (loss): Net gain/(loss) on available-for-sale (AFS) investments 35 (22) Exchange differences on translating foreign operations 370 (627) ------------- ------------- 405 (649) ------------- ------------- Total comprehensive loss (3,871) (7,704) ------------- ------------- See accompanying notes to unaudited interim condensed consolidated financial statements GPC Biotech AG Interim consolidated statement of financial position as of March 31, 2009 March 31, December 31, 2009 2008 (unaudited) Notes EUR 000 EUR 000 Assets Non-current assets Note receivable 2 15,142 - Property and equipment 479 524 Intangible assets 3,143 3,584 Other financial assets 146 146 ------------- ------------- Total non-current assets 18,910 4,254 Current assets Trade receivables 6 6 Prepayments 265 432 Other current assets 2,839 2,209 Available-for-sale investments 171 136 Cash and cash equivalents 11,251 31,686 ------------- ------------- Total current assets 14,532 34,469 Total Assets 33,442 38,723 ============= ============= Equity and Liabilities Equity attributable to the Company’s equity holders Issued capital 36,837 36,837 Share premium 366,400 369,654 Other reserves (3,513) (3,918) Retained loss (383,225) (378,949) ------------- ------------- Total equity 16,499 23,624 Non-current liabilities Convertible bonds 6 234 1,705 Deferred revenue, net of current portion 6 7,380 7,380 ------------- ------------- Total non-current liabilities 7,614 9,085 Current liabilities Trade payables 1,600 1,221 Accruals and other current liabilities 2 7,686 4,750 Deferred revenue, current portion 43 43 ------------- ------------- Total current liabilities 9,329 6,014 ------------- ------------- Total liabilities 16,943 15,099 Total equity and liabilities 33,442 38,723 ============= ============= See accompanying notes to unaudited interim condensed consolidated financial statements GPC Biotech AG Interim consolidated cash flow statement for the three months ended March 31, 2009 Three months ended March 31 2009 2008 (unaudited) (unaudited) EUR 000 EUR 000 Cash flows from operating activities Net loss for the period (4,276) (7,055) Adjustments for: Depreciation 70 227 Amortization 45 65 Compensation cost (reversal) for share-based payments (3,254) (921) Amortization of premium of marketable securities - 17 Impairment of property, equipment and intangible assets 407 17 Finance income (275) (605) Finance costs 29 189 Gain from the sale of property and equipment (4) (305) ------------- ------------- (7,258) (8,371) Decrease in other assets, non-current and current 341 894 Decrease in trade receivables - 642 Increase (decrease) in trade payables 324 (1,056) Decrease in deferred revenues - (1,238) Increase (decrease) in accruals and other liabilities 1,653 (1,583) ------------- ------------- Cash used in operating activities (4,940) (10,712) ------------- ------------- Interest received 49 153 Interest paid (1) - ------------- ------------- Net cash used in operating activities (4,892) (10,559) ------------- ------------- Cash flows from investing activities Purchase of property and equipment and intangible assets - (1) Proceeds from sale of property and equipment and intangible assets 5 207 Proceeds from sale of available-for-sale investments - 10,000 Purchase of note receivable (15,657) - ------------- ------------- Net cash (used in) provided by investing activities (15,652) 10,206 ------------- ------------- Cash flows from financing activities Repayment of convertible bonds (317) (445) ------------- ------------- Net cash used in financing activities (317) (445) ------------- ------------- Effect of exchange rate changes on cash and cash equivalents 426 (786) Changes in restricted cash - (14) ------------- ------------- Net decrease in cash and cash equivalents (20,435) (1,598) Cash and cash equivalents at beginning of period 31,686 49,681 ------------- ------------- Cash and cash equivalents at end of period 11,251 48,083 ============= ============= See accompanying notes to unaudited interim condensed consolidated financial statements GPC Biotech AG Interim consolidated statement of changes in equity For the three months ended March 31, 2009 Issued Share Retained Shares capital premium loss in EUR 000, excluding number of shares Balance at January 1, 2008 36,836,853 36,837 369,267 (357,665) Loss for the period (7,055) Other comprehensive loss Total comprehensive loss (7,055) Compensation cost (reversal) from share-based payment (921) ---------- ---------- --------- --------- Balance at March 31, 2008 (unaudited) 36,836,853 36,837 368,346 (364,720) ========== ========== ========= ========= Balance at January 1, 2009 36,836,853 36,837 369,654 (378,949) Loss for the period (4,276) Other comprehensive income Total comprehensive loss (4,276) Compensation cost (reversal) from share-based payment (3,254) ---------- ---------- --------- --------- Balance at March 31, 2009 (unaudited) 36,836,853 36,837 366,400 (383,225) ========== ========== ========= ========= Foreign Conv. AFS transl. Total bonds reserve reserve equity in EUR 000, excluding number of shares Balance at January 1, 2008 720 (162) (4,878) 44,119 Loss for the period (7,055) Other comprehensive loss (22) (627) (649) Total comprehensive loss (22) (627) (7,704) Compensation cost (reversal) from share-based payment (921) ---------- --------- --------- --------- Balance at March 31, 2008 (unaudited) 720 (184) (5,505) 35,494 ========== ========= ========= ========= Balance at January 1, 2009 720 23 (4,661) 23,624 Loss for the period (4,276) Other comprehensive income 35 370 405 Total comprehensive loss 35 370 (3,871) Compensation cost (reversal) from share-based payment (3,254) ---------- --------- --------- --------- Balance at March 31, 2009 (unaudited) 720 58 (4,291) 16,499 ========== ========= ========= ========= See accompanying notes to unaudited interim condensed consolidated financial statements
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, 2009 have been prepared in accordance with International Accounting Standard 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 Company’s annual financial statements for the year ended December 31, 2008.
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 Company’s annual consolidated financial statements for the year ended December 31, 2008, except for the adoption of new Standards and Interpretations as of January 1, 2009, as noted below:
IAS 1 Revised
As of 1 January 2009, the Company adopted International Accounting Standard 1 ®, Presentation of Financial Statements, (“IAS 1®). The revised Standard separates owner and non-owner changes in equity. The statement of changes in equity includes only details of transactions with owners, with non-owner changes in equity presented as a single line. In addition, the Standard introduces the statement of comprehensive income: it presents all items of recognized income and expense, either in one single statement, or in two linked statements. The Company has elected to present two statements. The changes required by IAS 1® did not affect the measurement or recognition of these items of comprehensive income.
Improvements to IFRSs
In May 2008, the Board issued its first omnibus of amendments to its standards, primarily with a view to removing inconsistencies and clarifying wording. There are separate transitional provisions for each standard. The adoption of the amendments resulted in minor changes to some of the Company’s accounting policies but did not have any impact on the financial position or performance of the Company.
As disclosed in the accompanying interim management report and Note 2 in the Company’s Annual Report for the year ended December 31, 2008, the ability of the Company to continue as a going concern on a stand-alone basis is at risk.
2. Business Developments
On February 18, 2009, GPC Biotech announced that it had signed a Business Combination Agreement with Agennix, Incorporated under which the two companies proposed to merge their businesses. Agennix is a privately held biotechnology company based in Houston, Texas. Agennix is developing talactoferrin, a novel oral anticancer therapy that is currently in two Phase 3 trials for non-small cell lung cancer. Talactoferrin has potential in other cancers, as well as non-cancer uses, such as diabetic foot ulcers. In the transaction, GPC Biotech is to be merged onto a new German company, which will hold all of the shares of Agennix and a EUR 15 million cash contribution by dievini Hopp BioTech holding GmbH & Co KG, which is also a party to the Business Combination Agreement and one of the largest shareholders of GPC Biotech. The merger is subject to the approval of the shareholders of GPC Biotech, the equity holders of the new company and to other closing conditions.
GPC Biotech expects its share of one time costs associated with this transaction to be approximately EUR 3.9 million which include banking fees, legal services and other one-time charges. In the three months ended March 31, 2009, the Company expensed approximately EUR 3.0 million of such costs which were included in Administrative expenses. Please see the Company’s Annual Report for the year ended December 31, 2008, for additional information.
In connection with the Business Combination Agreement, GPC Biotech made a $20 million (approximately EUR 15.7 million) loan to Agennix in the form of a senior secured convertible promissory note, bearing an interest rate of 12% per annum, which is included in non-current assets in the accompanying interim consolidated statement of financial position as of March 31, 2009.
3. Restructuring Activities
In March 2009, the Company implemented a corporate restructuring plan which resulted in a reduction in the total workforce of 8 employees, all located in the Princeton, New Jersey office. The Company incurred a total restructuring charge of approximately EUR 0.4 million related to this plan in the first quarter of 2009. 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 complete this restructuring plan by the end of 2009.
A summary of the significant components of the restructuring liability at March 31, 2009, is as follows (in thousand EUR ):
Employee Termination Lease Benefits Loss Total ------------ ---------- ---------- January 1, 2009 Balance 175 34 209 ------------ ---------- ---------- Amortization of Lease Loss - (16) (16) Restructuring Charges 350 - 350 Restructuring Payments (81) - (81) Exchange Differences 3 - 3 ------------ ---------- ---------- March 31, 2009 Balance 447 18 465 ============ ========== ==========
The restructuring liability of EUR 0.5 million and EUR 0.2 million as of March 31, 2009 and December 31, 2008, respectively, is included in accruals and other current liabilities in the accompanying condensed consolidated statements of financial position.
In the first quarter of 2009, the Company recorded an impairment charge on intangible assets of approximately EUR 0.4 million, which represented the difference between the fair value of the assets no longer used and their net carrying value.
4. Contingencies
From time to time, the Company may be party to certain legal proceedings and claims which arise during the ordinary course of business. Legal proceedings are subject to various uncertainties and the outcomes are difficult to predict. GPC Biotech may incur significant expense in defending these and future lawsuits. In the opinion of management, the ultimate outcome of these matters will not have material adverse effects on the Company’s financial position, results of operations or cash flows. In accordance with International Accounting Standard No. 37, Provisions, Contingent Liabilities and Contingent Assets, (“IAS 37"), the Company makes a provision for a liability when it is probable that a liability has been incurred and when the amount of the loss is reasonably estimable.
Shareholder litigation
On March 12, 2009, the Company announced that the U.S. District Court for the Southern District of New York issued an order dismissing the consolidated class action complaint against the Company. On April 1, 2009, the plaintiffs filed a motion seeking permission of the Court to file an amended consolidated class action complaint, and on May 1, 2009, the Company filed a response in opposition to such motion. The plaintiffs have until May 29, 2009, to reply to the Company’s response. Please see the Company’s Annual Report for the year ended December 31, 2008, for additional information.
Retention plan
In the first quarter of 2009, the Company paid approximately EUR 0.5 million to certain employees in accordance with the retention plan introduced in 2008. As of March 31, 2009, the Company has no remaining liability to any of its employees relating to the 2008 retention plan.
5. Shareholders’ Equity
As of March 31, 2009, GPC Biotech had conditional capital to potentially issue additional shares of the Company in the amount of EUR 17.4 million, with EUR 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 EUR 16.2 million.
No stock options or convertible bonds were exercised or converted for the three months ended March 31, 2009.
6. Additional Disclosures
Convertible bonds
Convertible bonds for the three months ended March 31, 2009, decreased 88% to EUR 0.2 million compared to EUR 1.7 million as of December 31, 2008. The decrease in convertible bonds is primarily due to the Company’s cancellation of convertible bonds. As of March 31, 2009, approximately EUR 1.5 million of convertible bonds are included in other current liabilities as the Company plans to repay these amounts within the next 12 months.
Revenue
The Company recognized no revenues for the three months ended March 31, 2009, compared to EUR 1.5 million for the same period in 2008. The decrease in revenues is due to the termination of the co-development and license agreement with Celgene in 2008.
Research and development expenses
Research and development (“R&D”) expenses for the three months ended March 31, 2009, decreased 74% to EUR 1.5 million compared to EUR 5.7 million for the same period in 2
