PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - August 05, 2010) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today announced financial results for the second quarter and first six months ended June 30, 2010.
Agennix AG was formed by the business combination of Agennix Incorporated and GPC Biotech AG, which became effective on November 5, 2009, and in which GPC Biotech AG was identified as the acquirer for accounting purposes. Accordingly, the comparative historical financial information of Agennix AG is that of GPC Biotech AG for the respective comparative periods.
First six months of 2010 compared to first six months of 2009
The Company recognized revenue of EUR 0 and EUR 0.1 million for the six months ended June 30, 2010 and 2009, respectively. Revenue for the six months ended June 30, 2009, was attributable to the services agreement with Agennix Incorporated prior to the effectiveness of the business combination.
Research and development (R&D) expenses for the six months ended June 30, 2010, increased 364% to EUR 11.6 million compared to EUR 2.5 million for the same period in 2009. The increase in R&D expenses was primarily due to increased clinical trial costs related to both of the Company's Phase 3 trials with talactoferrin (FORTIS-M and FORTIS-C) as a result of the inclusion of Agennix Incorporated's operations for the first six months of 2010 and a credit to compensation cost of EUR (1.5) million that was recognized for the first six months of 2009 as a result of the forfeiture of convertible bonds and stock options, which did not occur in 2010.
Despite the inclusion of Agennix Incorporated's operations for the six months ended June 30, 2010, administrative expenses decreased 31% to EUR 4.4 million compared to EUR 6.4 million for the same period in 2009. Included in administrative expenses as of June 30, 2009, were approximately EUR 3.0 million in one-time merger related costs (banking fees, legal services, audit and other related services) and a credit to compensation cost of EUR (1.8) million as a result of the forfeiture of convertible bonds and stock options. There were no such charges or credits in the six months ended June 30, 2010.
Net loss for the six months ended June 30, 2010, decreased 4% to EUR (8.2) million compared to EUR (8.5) million for the same period in 2009.
Basic and diluted loss per share was EUR (0.42) for the six months ended June 30, 2010, compared to EUR (1.15) for the same period in 2009. The per share amounts for 2009 have been retrospectively adjusted to reflect the effect of the 5 to 1 merger exchange ratio related to the merger of GPC Biotech AG into Agennix AG.
Second quarter of 2010 compared to second quarter of 2009
Revenues for the three months ended June 30, 2010 were EUR 0 compared to EUR 0.1 million for the same period in 2009. R&D expenses increased 371% for the second quarter of 2010 to EUR 6.6 million compared to EUR 1.4 million for the same period in 2009. Administrative expenses for the second quarter of 2010 decreased 4% to EUR 2.3 million compared to EUR 2.4 million for the same quarter in 2009. Net loss for the second quarter of 2010 was EUR (3.9) million compared to EUR (4.2) million for the second quarter of 2009. Basic and diluted loss per share was EUR (0.19) and EUR (0.57) for the second quarter of 2010 and 2009, respectively.
Quarter over quarter results: second quarter 2010 compared to first quarter 2010
The Company did not recognize any revenue in the first or second quarter of 2010. R&D expenses increased 32% to EUR 6.6 million for the second quarter of 2010, compared to EUR 5.0 million in the first quarter of 2010. Administrative expenses for the second quarter of 2010 increased 10% to EUR 2.3 million compared to EUR 2.1 million for the previous quarter. The Company's net loss was EUR (3.9) million for the second quarter of 2010, compared to EUR (4.3) million for the previous quarter. Basic and diluted loss per share was EUR (0.19) for the second quarter of 2010 compared to EUR (0.23) for the previous quarter.
Cash position
As of June 30, 2010, cash, cash equivalents and restricted cash totaled EUR 4.0 million (December 31, 2009: EUR 11.5 million). Net cash burn for the six months ended June 30, 2010, was EUR 17.5 million (June 30, 2009: EUR 11.4 million). The increase in net cash burn is primarily due to the inclusion of Agennix Incorporated's operations for the first six months of 2010 and increased clinical trials costs due to the progression of both of the Company's Phase 3 trials with talactoferrin. 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 interim consolidated cash flow statement for the respective periods.
Following the end of the second quarter, in July 2010, the Company announced that it had entered into an agreement with one of its major shareholders, dievini Hopp BioTech holding GmbH & Co. KG, pursuant to which dievini Hopp BioTech provided a EUR 15.0 million loan to Agennix. The loan bears an interest rate of 6% per annum, is unsecured and is repayable on thirty days advance notice, but not before October 15, 2010.
"We continue to make good progress in advancing our business," said Torsten Hombeck, Ph.D., Chief Financial Officer. "We have decided on a development path for talactoferrin in severe sepsis that should enable us to initiate a Phase 3 trial in early 2011. We also are pleased with the solid enrollment of patients in our Phase 3 FORTIS-M trial with talactoferrin in non-small cell lung cancer, keeping us on track with our anticipated timeline to see topline data from the trial in late 2011."
Financial guidance
The Company updated its financial guidance as follows:
Management expects no substantial cash generating revenues for the remainder of 2010 or for 2011. This guidance does not consider cash revenue from potential partnering of the Company's product candidates due to the uncertainty of the timing of such events.
For the remainder of 2010 and 2011, the Company expects R&D expenses to significantly increase compared to 2009 due to an expected steady increase in clinical trial-related costs as the Company's Phase 3 trials in non-small cell lung cancer with talactoferrin progress. In addition, the Company plans to initiate a Phase 3 program with talactoferrin in severe sepsis in early 2011.
Administrative expenses are expected to decrease in 2010 compared to 2009 as the one-time costs associated with the merger that were incurred in 2009 will not occur in the following years.
Management believes that, including the EUR 15 million loan from dievini Hopp BioTech, the Company currently has sufficient cash to fund its operations into the fourth quarter of 2010. The Company is pursuing both dilutive and non-dilutive sources of additional funding.
Appointment of interim CEO extended to end of 2010
The Company also today reported that the appointment of Friedrich von Bohlen, Ph.D., as interim Chief Executive Officer has been extended to December 31, 2010 to provide additional time for a permanent CEO to be put in place. Dr. von Bohlen's appointment was previously scheduled to expire on August 5, 2010.
Conference call scheduled
As previously announced, the Company has scheduled a conference call to which participants may listen via live webcast, accessible through the Agennix Web site at www.agennix.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 August 5 at 15:00 CET/9:00 AM EST. The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0)69 71044 5598
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 Agennix
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company's most advanced program is talactoferrin, an oral therapy that has demonstrated activity in randomized, double-blind, placebo-controlled Phase 2 studies in non-small cell lung cancer, as well as in severe sepsis. Talactoferrin is currently in Phase 3 clinical trials in non-small cell lung cancer, and Agennix plans to develop this program further for the treatment of severe sepsis. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Planegg/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG, including statements about the Company's future cash position and the status of its clinical development programs for talactoferrin. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond the control of the Company, 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. There can be no guarantee that the Company will move talactoferrin forward in development for severe sepsis in a timely manner, if at all, or that talactoferrin will ultimately be approved for sale in any country. Actual results could differ materially depending on a number of factors, and management cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
- Financials follow -
For the full management report and condensed consolidated financial statements and accompanying notes for the second quarter and first six months ended June 30, 2010, please see the Investor Relations section of the Agennix website at http://www.agennix.com/index.phpoption=com_content&view=article&id=122&Itemid=77&lang=en.
Agennix AG
Interim consolidated statement of operations
Three months ended Six months ended
June 30, June 30,
2010 2009 2010 2009
(unaudited) (unaudited) (unaudited) (unaudited)
EUR 000 EUR 000 EUR 000 EUR 000
Revenue - 103 - 103
Research and
development expenses (6,635) (1,400) (11,612) (2,530)
Administrative expenses (2,306) (2,436) (4,395) (6,360)
Amortization of
intangible assets (11) (43) (50) (88)
Impairment of
intangible assets - - - (407)
Other income 2,930 377 4,555 1,341
Other expenses (81) (1,135) (586) (1,114)
Finance income 4 477 5 752
Finance costs (2) (135) (4) (164)
----------- ----------- ----------- -----------
Net loss before tax (6,101) (4,192) (12,087) (8,467)
Income tax benefit 2,248 - 3,905 -
----------- ----------- ----------- -----------
Net loss for the period (3,853) (4,192) (8,182) (8,467)
=========== =========== =========== ===========
Basic and diluted loss
per share, euro (1) (0.19) (0.57) (0.42) (1.15)
Average number of
shares used in
computing basic and
diluted loss per
share(1) 20,589,577 7,367,370 19,658,314 7,367,370
(1) Per share and share amounts for 2009 have been retrospectively adjusted
to reflect the effect of the 5 to 1 merger exchange ratio related to
the merger of GPC Biotech AG into Agennix AG (see Note 3 of the
consolidated financial statements as of December 31, 2009).
Agennix AG
Interim consolidated statement of financial position
June 30, 2010 December 31,
(unaudited) 2009
EUR 000 EUR 000
Assets
Non-current assets
Property and equipment 3,599 3,416
Intangible assets 107,982 91,881
Other non-current assets 2,324 2,040
------------- -------------
Total non-current assets 113,905 97,337
Current assets
Trade receivables - 35
Prepayments 281 596
Other current assets 418 259
Cash and cash equivalents 3,919 11,413
------------- -------------
Total current assets 4,618 12,303
Total Assets 118,523 109,640
============= =============
Equity and Liabilities
Equity attributable to the Company's equity
holders
Issued capital 20,667 18,705
Share premium 94,654 86,237
Other reserves 8,438 (1,863)
Retained loss (24,679) (16,497)
------------- -------------
Total equity 99,080 86,582
Non-current liabilities
Convertible bonds 210 210
Other non-current liabilities 29 33
Deferred tax liability 14,352 15,850
------------- -------------
Total non-current liabilities 14,591 16,093
Current liabilities
Trade payables 1,070 1,592
Accruals and other current liabilities 3,782 5,330
Deferred revenue, current portion - 43
------------- -------------
Total current liabilities 4,852 6,965
------------- -------------
Total liabilities 19,443 23,058
Total equity and liabilities 118,523 109,640
============= =============
Agennix AG
Selected Financial Data
Interim Consolidated Cash Flow Statement
Six months ended June 30,
2010 2009
(unaudited) (unaudited)
EUR 000 EUR 000
Net cash used in operating activities (17,292) (11,392)
Net cash used in investing activities (175) (15,517)
Net cash provided by (used in) financing
activities 9,705 (332)
Effect of exchange rate changes on cash and
cash equivalents 266 250
Changes in restricted cash 2 -
Net decrease in cash and cash equivalents (7,494) (26,991)
Cash and cash equivalents at beginning of
period 11,413 31,686
Cash and cash equivalents at end of period 3,919 4,695
For further information, please contact:
Agennix AG
Investor Relations & Corporate Communications
Phone: +49 (0)89 8565 2693
ir@agennix.com
In the U.S.:
Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
laurie.doyle@agennix.com
Additional media contact for Europe:
MC Services AG
Raimund Gabriel
Phone: +49 (0)89 210 228 0
raimund.gabriel@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Williams
Vice President
Phone: +44 207 936 9325
lwilliams@troutgroup.com
