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

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:

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

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 at and on Transgene's website at .

Consolidated interim balance sheet, IFRS

(in thousands of euros)

ASSETS   30.06.2013   31.12.2012*

Current assets:

Cash and cash equivalents 8,243 6,137
Other current financial assets 63,801 86,778
Cash, cash equivalent and other financial assets: 72,044 92,915
Receivables 898 2,012
Inventories 897 1,107
Other current assets   9,296   2,340
Total current assets   83,135   98,374

Non-current assets:

Property, plant and equipment 24,374 24,805
Intangible assets 1,468 1,497
Financial assets 10,171 7,382
Equity consolidated affiliates 4,307 3,932
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:    
Payables 10,279 9,587
Financial liabilities 8,848 961
Provisions for risks 1 2
Other current liabilities   6,045   8,853
Total current liabilities   25,173   19,402

Non-current liabilities:

Financial liabilities 38,101 38,006
Defined benefit obligations 4,828 4,584
Other non-current liabilities   -   252
Total non-current liabilities   42,929   42,842
Total liabilities   68,102   62,244


Share capital 72,886 72,886
Share premiums 427,629 427,258
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) 3 24
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 elements 1,121 83
Elimination of non-cash elements:
Income from equity consolidated affiliates 126 200
Changes in provisions 461 130
Depreciation and amortization of tangible and intangible assets 1,386 1,368
Payments in shares 371 436
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:
Receivables 1,280 (416)
Inventories 210 (82)
Research tax credits (3,688) (3,992)
Other current assets 616 (190)
Payables 831 (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 assets 22,678 26,878
Research tax credit financing 7,418 6,500
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

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
MC Services
Raimund Gabriel, +49 89 210 228 30
Shaun Brown, +44 207 148 5998

KEYWORDS:   United States  Europe  North America  France  New York


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