Transgene Reports 2013 Half Year Results

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Transgene Reports 2013 Half Year Results

  • €72 million (above $90 million) in cash at end of June 2013
  • Important news-flow in Q4 for the two lead programs, TG4010 and Pexa-Vec

STRASBOURG, France--(BUSINESS WIRE)-- Regulatory News:

Transgene (Paris:TNG) announces today its financial results for the six-month period ended June 30, 2013. The Interim Financial Report is available on the Company's website at http://www.transgene.fr.


Revenue amounted to €6.7 million in the first six months of 2013, compared to €6.1 million in the first six months of 2012. Research and development expenses were €25.5 million in the first six months of 2013, compared to €23.8 million in the first six months of 2012. This increase was mainly due to increased expenses on clinical trials. G&A expenses were €3.3 million in the first six months of 2013, unchanged.

In the first six months of 2013, net loss and net loss per share amounted respectively to €23.2 million and €0.73 (vs. respectively €21.8 million and €0.68 in the first six months of 2012).

Cash consumption amounted to €20.9 million in the first half of 2013. Transgene had €72 million in cash as of June 30, 2013. The Company confirmed its guidance of cash burn of approximately €50 million for the full year 2013.

"R&D expenses, net loss and cash consumption for the first six months of 2013 are in line with our guidance" said Stéphane Boissel, EVP and CFO of Transgene. He added: "We anticipate R&D expenses to increase going forward as we hope to enter our most advanced programs into late-stage clinical development and expect to continue to advance and grow our R&D pipeline".

"Over the last 24 months, we have expanded and enhanced our clinical operations to aggressively drive forward TG4010 and Pexa-Vec, our two lead product candidates, in clinical development.We look forward to reporting key clinical data in non-small cell lung cancer with TG-4010, as well as announcing our decision on the further development of Pexa-Vec in liver cancer, in the fourth quarter of this year" said Philippe Archinard, Chairman and CEO of Transgene. He added: "In addition to these advanced programs, Transgene continues to build its pipeline using its core technologies in viral vectors to develop future immunotherapy breakthroughs to treat cancer and infectious diseases".

Key news since January 2013:

Research and development:

  • TG4010: Phase 2b TIME trial in non-small cell lung cancer 90% recruited as of June 2013.
  • Pexa-Vec: Phase 2b TRAVERSE trial in advanced hepatocellular carcinoma (HCC) - trial does not meet primary endpoint of overall survival; additional analyses ongoing.
  • TG4040: Phase 2 data presented at European Association for the Study of the Liver Conference (EASL).
  • TG1050: Encouraging pre-clinical data in chronic hepatitis B and TG1050 presented at EASL.

Corporate and business development:

  • Agreement signed with Sanofi/Genzyme for the future commercial production of Transgene's products.
  • Investments made in ElsaLys Biotech, a therapeutic antibody company started by former Transgene executives, and in Jennerex, Inc., co-developer of Pexa-Vec.
  • Two new members appointed to Board of Directors: Laurence Zitvogel, MD, professor of immunology and biology at Paris University and Jean-Luc Bélingard, Chairman and Chief Executive Officer of bioMérieux S.A.
  • TG1042: License granted to immunotherapy company Ascend Biopharmaceuticals for development and commercialization in basal cell carcinoma and two other cancer indications.

Expected key news flow:

  • Top-line data from Phase 2b TIME trial evaluating TG4010 in patients with non-small cell lung cancer (Q4 2013).
  • Decision to move Pexa-Vec into Phase 3 in HCC. (Q4 2013).
  • Novartis decision re: TG4010 development and commercialization option (Q1 2014).

English conference call numbers - First Half Results - 18:45 CEST:

Webcast link:

http://www.media-server.com/m/p/dymgqjm8

Participant Telephone Numbers:

Participants, Local - London, United Kingdom:   +44(0)20 3427 1907
Participants, Local - New York, United States of America:+1212 444 0481
Participants, Local - Paris, France:+33(0)1 76 77 22 23

Confirmation Code: 5907501

Participants will have to quote the above code when dialing into the conference.

Duration of this call in English is 45 minutes.

About Transgene:
Transgene (NYSE-Euronext: TNG), a member of the Institut Mérieux Group, is a biopharmaceutical company. We create, develop and manufacture targeted immunotherapeutics for the treatment of cancers and infectious diseases. Our products are major technological breakthroughs that use generally well tolerated viruses to indirectly or directly kill infected or cancerous cells. Our four most advanced products have generated proof of concept data in randomized clinical studies: in lung cancer (TG4010), liver cancer (Pexa-Vec), hepatitis C (TG4040) and HPV-related cervical lesions (TG4001). We have concluded strategic agreements for the development of three of these products: an option agreement with Novartis for the development of TG4010, an in-licensing agreement with US-based Jennerex, Inc. to develop and market Pexa-Vec and a strategic collaboration with EORTC to develop TG4001 in cancer of the oropharynx. We also have a non-exclusive agreement with Sanofi/Genzyme for the future commercial production of our products. Most of our 280 employees are based in Strasbourg, France, and we have operations in Lyon, China and the USA. Additional information about Transgene is available at www.transgene.fr.

Disclaimer:
This press release contains forward-looking statements notably referring to the anticipated cash consumption for 2013. The Company's anticipated cash consumption for 2013 is based on currently anticipated costs for on-going and planned product development and testing, but may increase in the event of unanticipated expenses. For further information on the risks and uncertainties involved in the testing and development of Transgene's product candidates, see Trangene's Document de Référence on file with the French Autorité des marchés financiers on its website athttp://www.amffrance.organd on Transgene's website atwww.transgene.fr.

Consolidated interim balance sheet, IFRS

(in thousands of euros)

ASSETS 30.06.2013 31.12.2012*

Current assets:

  
Cash and cash equivalents8,2436,137
Other current financial assets63,80186,778
Cash, cash equivalent and other financial assets:72,04492,915
Receivables8982,012
Inventories8971,107
Other current assets 9,296 2,340
Total current assets 83,135 98,374

Non-current assets:

Property, plant and equipment24,37424,805
Intangible assets1,4681,497
Financial assets10,1717,382
Equity consolidated affiliates4,3073,932
Other non-current assets 20,243 24,474
Total non-current assets 60,563 62,090
Total assets 143,698 160,464
EQUITY and LIABILITIES 30.06.2013 31.12.2012*
Current liabilities:  
Payables10,2799,587
Financial liabilities8,848961
Provisions for risks12
Other current liabilities 6,045 8,853
Total current liabilities 25,173 19,402

Non-current liabilities:

Financial liabilities38,10138,006
Defined benefit obligations4,8284,584
Other non-current liabilities - 252
Total non-current liabilities 42,929 42,842
Total liabilities 68,102 62,244

Equity:

Share capital72,88672,886
Share premiums427,629427,258
Retained earnings(399,849)(356,655)
Net loss for the period(23,166)(43,194)
Other comprehensive income (1,904) (2,075)
Total equity and reserves attributable to equity holders of the Company 75,596 98,220
Total equity and liabilities 143,698 160,464

* 2012 accounts as modified in accordance with the new IAS19, retroactively applicable (Note 1.8.3)

Consolidated interim income statement, IFRS
(in thousands of euros, except for per share data)

  30.06.2013 30.06.2012*
Revenue from collaborative and licensing agreements 1,401 1,593
Government financing for research expenditures 5,313 4,481
Revenue 6,714 6,074
Research and development expenses(25,458)(23,811)
General and administrative expenses(3,265)(3,313)
Other income and (expenses), net (226) (424)
Net operating expenses (28,949) (27,548)
Operating income / (loss) (22,235) (21,474)
Interest income and (expenses), net (805) (81)
Income / (loss) before tax (23,040) (21,555)
Income tax expense - -
Income from equity consolidated affiliates (126) (200)
Net income/ (loss) (23,166) (21,755)
Net income per share (€)(0.73)(0.68)
Diluted earnings per share (€)(0.73)(0.68)

* 2012 accounts as modified in accordance with the new IAS19, retroactively applicable (Note 1.8.3)

Comprehensive income (IFRS)
(in thousands of euros)

  30.06.2013 30.06.2012*
Net income / (loss) (23,166) (21,755)
Foreign exchange gains / (losses)324
Reevaluation of hedging instruments 168 (126)
Other comprehensive income 171 (102)
Comprehensive income (23,337) (21,857)
Of which, equity holder of the parent(23,337)(21,857)
Of which, minority interests--

* 2012 accounts as modified in accordance with the new IAS19, retroactively applicable (Note 1.8.3)

Consolidated interim cash flow statement, IFRS
(in thousands of euros)

  30.06.2013 30.06.2012*
Cash flow from operating activities:  
Net income(23,166)(21,755)
Elimination of financial elements1,12183
Elimination of non-cash elements:
Income from equity consolidated affiliates126200
Changes in provisions461130
Depreciation and amortization of tangible and intangible assets1,3861,368
Payments in shares371436
Others 182 -

Net cash generated from / (used in) operating activities
before change in working capital and other operating cash flow:

 (19,796) (19,538)
Changes in operating working capital:
Receivables1,280(416)
Inventories210(82)
Research tax credits(3,688)(3,992)
Other current assets616(190)
Payables831(2,081)
Prepaid income(2,316)(401)
Accrued employee benefits expense(564)(316)
Other current liabilities (180) (242)
Net cash generated from / (used in) operating activities: (23,607) (27,068)
Cash flow from investing activities
(Purchase) / disposal of property, plant and equipment(1,122)(827)
(Purchase) / disposal of intangible assets(126)(148)
Other (purchases) / disposals (2,442) -
Net cash generated from / (used in) investing activities: (3,690) (975)
Cash flow from financing activities
Net cash interest(394)240
Gross proceeds from issuance of share capital-110
Fees paid in relation to capital increase--
Conditional subsidies-3,116
(Acquisition) / disposal of current financial assets22,67826,878
Research tax credit financing7,4186,500
Repayment of finance lease liabilities (301) 138
Net cash generated from / (used in) financing activities 29,401 36,982
Effect of changes in exchange rates on cash and cash equivalents 3 24
Net increase (decrease) in cash and cash equivalents 2,107 8,963
Cash and cash equivalents at beginning of period 6,137 1,733
Cash and cash equivalents at end of period 8,244 10,696
Investments in other financial assets 63,800 110,726
Cash, cash equivalents and other financial assets 72,044 121,422

* 2012 accounts as modified in accordance with the new IAS19, retroactively applicable (Note 1.8.3)

Société anonyme au capital de 72.886.317 € - R.C. Strasbourg B 317 540 581
Boulevard Gonthier d'Andernach - 67400 Illkirch-Graffenstaden (France)
Tél : + 33-03 88 27 91 00 Fax : +33-03 88 27 91 11



Transgene
Philippe Archinard, Chairman & CEO, +33 (0)3 88 27 91 22
Stéphane Boissel, Executive Vice President & CFO, +33 (0)3 88 27 91 02
Elisabetta Castelli, Director IR, +33 (0)3 88 27 91 21
or
MC Services
Raimund Gabriel, +49 89 210 228 30
Shaun Brown, +44 207 148 5998

KEYWORDS:   United States  Europe  North America  France  New York

INDUSTRY KEYWORDS:

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