Transgene in 2007: Partnership and Refinancing Position the Company for its Future Development

Transcription

1 Strasbourg, 11 March 2008 Transgene in 2007: Partnership and Refinancing Position the Company for its Future Development Strasbourg, France, March 11, 2008 Transgene (Euronext Paris: FR ) announces today its achievements in operations, financial performance for 2007 and outlook for «2007 was a breakthrough year for Transgene, marked by two major accomplishments: the signing of a partnership agreement with Roche in the domain of therapeutic vaccines for the treatment of diseases caused by the HPV virus, and the successful completion of a 100.1m capital increase on European markets», declared Philippe Archinard, Managing Director of Transgene. Key financial highlights include: Total revenues for the year were 28million compared to 5.5m in Transgene closed the year with a net loss of 5.5m compared to a net loss of 22m a year earlier. Basic loss per ordinary share was 0.28 versus 1.41 in Research and development expenditures were 28.8m compared to 24.2m in In 2007, net cash expenditure, excluding capital increase, was 5.5m compared to 20.7m in At the end of 2007, the company held cash and cash equivalents of 111.3m, which should enable it to finance some four years of operating costs. Major Accomplishments of 2007: Partnership Roche /Transgene: announced in April 2007, an exclusive world wide license agreement aimed at the development, registration and commercialisation of Transgene s therapeutic vaccines developed to fight diseases caused by the Human Papilloma Virus. Transgene received an upfront payment and a regulatory milestone of 23m in June 2007 and may receive further payments of up to 195m covering clinical development milestones and commercial milestones based on future sales of HPV products, stemming from Transgene s research. Under the terms of the agreement, Transgene is also entitled to receive progressive, double digit royalties on all future sales. Strengthening of the Equity Base: In July 2007, the company raised 100.1m ( 96.4m net of costs) from European equity markets in an institutional rights offering involving the issue of 5,484,977 shares at a price of per share. Fifty-five percent of the issue was subscribed by TGSH (Groupe Mérieux Alliance), Transgene s major shareholder. Overall, the offering was five times oversubscribed. / Société anonyme au capital de R.C. Strasbourg B , rue de Molsheim Strasbourg Cedex (France) Tél : Fax :

2 Outlook for 2008: With 111.3m of cash as of year-end 2007, and strengthened by a major validating partnership agreement, Transgene has a solid platform to accelerate the development of its pipeline and growth of the company. We should report strong newsflow throughout 2008 including clinical trial results on three of our vaccine candidates in the pipeline: (i) TG4010, for non-small cell lung cancer, in phase IIb - an independent central radiological reading has recently confirmed the observed difference in favour of the combination of our vaccine with chemotherapy; (ii) TG1042, for relapsed cutaneous B-cell Lymphoma, where we expect phase II interim results at the end of the 2 nd quarter due to slower than anticipated patient recruitment and (iii) TG4040, for chronic hepatitis C, in phase I where initial tolerance and efficacy data are expected shortly, Philippe Archinard added. Further to our clinical results newsflow, Roche expects to enter TG4001/R3484 into Phase III clinical trials by the end of Moving forward, thanks to its continuous internal research efforts, Transgene is broadening its technological base and intends to expand its clinical portfolio. Our objective is to move one new product candidate into clinical development each year. We believe that Transgene is ideally positioned to become a leader in the field of cancer and infectious diseases immunotherapy, concluded Philippe Archinard. Main Developments in the Product Portfolio: TG4001/R3484 (MVA-HPV-IL2) for the treatment of precancerous cervical lesions caused by the HPV virus. According to the terms of our partnership agreement signed in April 2007, Roche will be responsible for the development and commercialisation of the vaccine worldwide. Phase II trials have been completed and Roche expects TG4001/R3484 to enter into phase III clinical trials by the end of A further development milestone payment will be triggered upon the treatment of the first patient in the phase III clinical study. TG4010 (MVA-MUC1-IL2) for the treatment of non small cell lung cancer in combination with chemotherapy. The recruitment of 148 patients in the controlled study of phase IIb initiated at the beginning of 2006 was completed in May Local radiological evaluations realised in the clinical centres showed a difference in favour of the combination of our vaccine with chemotherapy compared to chemotherapy alone. This difference was confirmed by a recently completed independent central radiological reading. Full interim results of the trial data (response rate, progression-free survival and overall survival) should be released on the occasion of a major scientific conference organised for the end of the 2 nd quarter. We will be announcing final results by the end of TG1042 (Ad-IFNγ) for the treatment of relapsed cutaneous B-cell lymphoma (CBCL). A phase II trial was launched end 2006 in France, Switzerland and the United States. The objective was the recruitment of 41 patients suffering from relapsed cutaneous B-cell lymphoma after treatment with radiotherapy. CBCL, a malignant disease of the skin is a rare illness which affects between 10,000 and 15,000 patients in Europe and the United States. Recruitment of patients has proven to be slower than anticipated for the phase II trial of this orphan indication. 2

3 As a consequence we expect a delay in the interim results data which is now anticipated for the end of the 2 nd quarter TG4040 (MVA-HCV) for the treatment of hepatitis C: a phase I trial began in France in the 1 st quarter Fifteen patients were recruited who had not received any previous treatment for their infection. Patients received one subcutaneous injection per week for 3 weeks of TG4040 at doses of 10 6 pfu (3 patients), 10 7 pfu (3 patients) and 10 8 pfu (9 patients). The patients treated with the higher dose receive a complementary injection ( boost ) at six months. The tolerance and efficacy data after the first injections are expected shortly. The complete efficacy results of the clinical study (after the full treatment schedule including boost) are expected in the 4 th quarter We have extended the ongoing clinical trial to include patients with more advanced stages of liver disease, in order to potentially enlarge the target patient population, and also to assess shortened administration schedules of the vaccine (2 and 4 month intervals between prime and boost injections). In parallel a phase I study is in progress in Canada, co-financed by the University of Montreal, involving patients who have relapsed after having received standard of care treatment (Ribavirine and Interferon Alpha). Results of this study should be available in the first half of Expanding the Pipeline: In 2005, we took the decision to focus resources on fewer clinical developments to accelerate the establishment of proof of concept and the subsequent signing of strategic partnership agreements. At the same time, with the goal of bringing one new product into clinical development each year, we carried out a major reorganisation of our research group with three objectives: To broaden our technological base in the field of immunotherapeutics; To develop a superior biomarker platform in order to maximise probability of success and efficiency of our clinical developments; and To reinforce the medical and market-oriented drive of our research activities. The company has achieved these goals and is now in a position to reactivate the clinical development of products that were put on hold, and to initiate the development of new therapeutic vaccines and passive immunotherapeutics, either specific or non specific. The company intends to disclose details of its preclinical and clinical programmes at an R&D presentation, which we plan to schedule for mid-year

4 2007 Financial Results Summary Statement of Operations (IAS/IFRS) (Amounts in thousands of euros except share and Twelve months ended december 31, per share date) (unaudited) (audited) Total revenues Operating expenses Research and development (28 799) (24 155) General and administrative (5 747) (3 928) Other operating gains and losses (931) 23 Total operating expenses (35 477) (28 060) Profit (loss) from operations (7 458) (22 514) Interest and other income, net Profit (loss) attributable to equity holders of the parent (5 521) (22 031) Basic profit (loss) per ordinary share (0.28) (1.41) Comments on 2007 Financial Results Revenues million Trend Third Party Manufacturing Contracts % AFM Contract % Revenues from Roche partnership N/A Revenues from Licenses % Grants % Research Tax Credits % Total x 5.1 In 2007 total revenues were 28m compared to 5.5m in The substantial increase in revenues is a consequence of the payment of 23m received from Roche as part of the licensing agreement. Revenues from third party manufacturing services remained stable at 1.4m. Deferred revenues from manufacturing contracts amounted to 3m at end 2007 and will be recorded as revenues in 2008 following delivery and acceptance of the manufactured products by clients. Cash receipts tied to these contracts have declined from 2.7m in 2006 to 1.8m in

5 Third party manufacturing contracts and their corresponding revenues will progressively be replaced by the manufacture of the vaccine TG4001/R3484 which will be invoiced to Roche. Billings to the French Muscular Dystrophy Association (AFM) have declined by some 60% and reflect the decline in the workload on the preclinical Myodys programme. Excluding revenues stemming from our partnership agreement with Roche ( 23m), license revenues slightly increased to 0.7m in 2007 against 0.6m in Research grants progressed from 0.3m in 2006 to 0.5m in They essentially relate to the hepatitis C programme. Research and development tax credits increased by 13% to 1.7m in 2007 as a result of an increase in eligible research expenses. The research tax credit will be reimbursable to the company in 2011, less any amounts applied to offset income taxes due. The French reform on research tax credits will have a favourable impact on our research tax credit for Operating Expenses In 2007, Transgene made significant investments in new personnel. This was consistent with having reached certain milestones: our partnership agreement with Roche and late stage clinical development of our product portfolio. Research and Development expenses amounted to 28.8m in 2007 compared to 24.2m in The increase was mainly due to: - Increase in personnel costs of 1.7m; - The cost of clinical trials increased by 1.3m, largely due to the ongoing phase IIb clinical studies on TG4010; - Higher bio-manufacturing activities (+ 0.7m); - Acquisition and amortization of technological licences (+ 0.5m); and - An increase in non cash expenses of 0.5m (amortization of stock options) Administrative and general expenses reached 5.7m in 2007 against 3.9m in The major reasons were: - Increase in personnel costs of 0.3m; - Expenses and taxes related to the licensing contract with Roche (+ 0.7m); and - An increase in non cash expenses of 0.2m (amortization of stock options). Other Charges Other charges totalled 0.9m in 2007 and mainly reflected a provision to cover the cost of leaving our rented office premises in Strasbourg. Transgene has decided to regroup all the company s personnel at Illkirch, a Strasbourg suburb where the current production site is located, and expects to move there by the end of A new leased building of some m² is currently under construction for mixed usage (laboratories and offices). The objective is to optimize our R&D resources through the provision of more suitable premises. Globally the cost of these premises will equal that of the current rental costs, after initial expenditure on new equipment and other service expenses. 5

6 Interest Income Interest income was 1.9m in 2007 compared to 0.5m in Interest income consisted of investment income resulting from the proceeds of the capital increase and the partnership agreement. Net Loss Transgene reported a net loss of 5.5m in 2007 compared to 22.0m in Basic loss per ordinary share amounted to 0.28 in 2007 compared to 1.41 in 2006, due to the combined reduction in net losses and the increase in the average number of shares in issue after the rights issue of July Liquidity and Capital Resources As of 31 December 2007, Transgene held 111.3m in cash and cash equivalents compared to 20.3m a year earlier. Cash equivalents are invested in short-term money market funds. A capital increase of 100.1m ( 96.4m net) was completed in June and July 2007 involving the issue of 5,484,977 shares at a price of cents per share. The financing by OSEO/AII of the ADNA programme («Advanced Diagnostics for New Therapeutic Approaches») is currently under review by the European Commission and we expect a decision during the second quarter of The specific aid sought, to be received over the life of the program, breaks down into 8.6m of grants and of 9.8m repayable advances. The amount of aid has been adjusted relative to the estimate of 25m announced on 24 November This is due to the exclusion of certain costs relative to the HPV programme which is now licensed to Roche. In 2007, net cash expenditures, excluding the capital increase, were 5.5m compared to 20.7m in Transgene currently anticipates a cash burn for 2008 in the order of 20m to 25m depending on the outcome of the requested aid to OSEO/AII. Telephone Conference Call A telephone conference call is organised today, 11th March 2008, in English at 7pm Paris time (6pm London time). To participate in the conference please dial one of the following numbers 10 minutes before the conference begins (0) or + 44 (0)

7 About Transgene Transgene, based in Strasbourg, is a biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has one product which has completed Phase II trials (TG4001/R3484), two compounds in Phase II trials (TG4010 and TG1042) and one compound in Phase I studies (TG4040). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG4001/R3484 therapeutic vaccine to treat HPV-mediated diseases. Transgene has bio-manufacturing capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at Cautionary note regarding forward-looking statements This press release contains forward-looking statements referring to the planned development and clinical testing of Transgene s vaccine candidates. However, successful product development and clinical testing depend on a variety of factors, including the timing and success of future patient enrolment and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favourable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial use. This press release also contains forward-looking statements referring to potential future milestone payments under Trangene s partnership agreement with Roche. However, the payment of such amounts requires satisfaction of the relevant contractual conditions, which depends in part on factors outside the control of the Company. For further information on the risks and uncertainties involved in the testing of Transgene s product candidates, and in connection generally with the development of its products, see Trangene s Document de référence on file with the French Autorité des marchés financiers on its website at and Transgene s website at Press Contacts: Transgene Capital MS&L Philippe Poncet Anna Mitchell Finance Director Phone: +44 (0) Phone: +33 (0)

8 Condensed Consolidated Balance Sheets (IAS/IFRS) (Amounts in thousands of euros) December 31, December 31, (unaudited) (audited) ASSETS Fixed assets, net Intangible assets, net Financial assets, net Other non-current assets Total non-current assets Cash and cash equivalents Other current assets Total current assets Total assets LIABILITIES AND SHAREHOLDERS' EQUITY Shareholders' equity Liabilities, non current Liabilities, current Total liabilities and shareholder's equity Condensed Consolidated Statements of Operations (IAS/IFRS) (Amounts in thousands of euros except share and Six months ended december 31, Twelve months ended december 31, per share date) (unaudited) (audited) (unaudited) (audited) Revenues Revenues from collaborative and licensing agreements Grants and tax credit received for research Total revenues Operating expenses Research and development (15 722) (12 435) (28 799) (24 155) General and administrative (3 105) (2 125) (5 747) (3 928) Other operating gains and losses 7 12 (931) 23 Total operating expenses (18 820) (14 548) (35 477) (28 060) Profit (loss) from operations (15 546) (11 787) (7 458) (22 514) Interest and other income, net Net profit (loss) (13 983) (11 396) (5 521) (22 031) Profit (loss) attributable to equity holders of the parent (13 983) (11 396) (5 521) (22 031) Basic profit (loss) per ordinary share (0.63) (0.69) (0.28) (1.41) Diluted profit (loss) per ordinary share (0.63) (0.69) (0.28) (1.41) Average number of outstanding shares

9 CONSOLIDATED CASH FLOW STATEMENT (IAS/IFRS) (in thousands of Euros) Cash flows from operating activities Unaudited Audited Operating loss (7 458) (22 514) Adjustments for: Changes in provisions Depreciation and amortization Amortization of stock option costs Change in operating working capital Other (63) (74) Net cash used in operations (4 045) (20 054) Other operating cash flows Interest received Interest paid (71) (85) Net cash used in operating activities (2 073) (19 538) Cash flows from investing activities Purchases of property, plant and equipment (992) (745) Proceeds from sales of intangible assets (1 645) (42) Proceeds from disposals (purchases) of available-for-sale financial assets, net Other (171) (6) Net cash from (used in) investing activities (2 808) Cash flows from financing activities Proceeds from issues of share capital Transaction costs to issue shares (4 524) (49) Repayments of lease liabilities (546) (291) Net cash provided by financing activities Effect of changes in exchange rates on cash and cash equivalents (1) (2) Net increase (decrease) in cash and cash equivalents Cash and cash equivalents at 1 January Cash and cash equivalents at 31 December