Leuven, Belgium – 12 March, 2009 - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on the discovery and development of innovative treatments that will make a real difference to patient care in a number of important therapeutic areas, is today issuing a business update and its financial results for the full year ending December 31, 2008.
During the last twelve months, ThromboGenics has made considerable progress across all aspects of its business culminating in the recent start of the Phase III clinical development program for its lead product microplasmin in back of the eye disease. The decision to start the Phase III program was based on the positive Phase II clinical results which were announced over the course of 2008.
In June 2008, ThromboGenics announced a further important corporate milestone, the signing of a high value strategic alliance with Roche for its novel anti-cancer antibody TB-403 (anti-PIGF). This deal, which generated an upfront payment of €30 million, has provided significant funding to allow ThromboGenics to invest in its other development programs. The upfront payment from the Roche deal has enabled ThromboGenics to report a pre-tax profit of € 12.2 million in 2008. Given its recent progress, ThromboGenics is confident that over the next eighteen months it will be able to generate significant shareholder value as it continues to maximize the value of its exciting product pipeline.
Business Highlights
Clinical Highlights
Microplasmin – Eye Disease: Positive results announced in Phase II clinical trials for back of the eye indications. Positive results were reported in ThromboGenics’ Phase IIb (MIVI III) trial in patients with a number of back of the eye conditions. The trial showed that the most effective dose of microplasmin studied (125 µg) was able to resolve the underlying disease in approximately 30% of patients within 1 week of treatment, removing the need for surgical intervention in these patients. Microplasmin - Eye Disease: Phase III clinical program to evaluate non surgical treatment of patients with vitreomacular adhesion. In January 2009, ThromboGenics announced the start of the Phase III clinical program of microplasmin for the non-surgical treatment of back of the eye disease. The Phase III program comprises two clinical trials, taking place in the United States (TG-MV-006 trial) and combined Europe and US (TG-MV-007 trial). The initial indication for both of the Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Both of these trials will use the 125µg dose of microplasmin and include 320 patients each.
Microplasmin for Vascular Disease – Encouraging Phase II results in acute ischemic stroke. In September, Professor Vincent Thijs, KULeuven, presented the results from this 40 patient study at the World Stroke Congress in Vienna, Austria. It remains ThromboGenics’ intention that it will only move forward with the development of microplasmin for the treatment of stroke in conjunction with a partner.
TB-402 – Anti-coagulant: Begins Phase II trial in patients undergoing orthopaedic surgery. In February 2009, ThomboGenics announced that the first patient had been enrolled in the Phase II trial with their long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopaedic surgery. TB-402, which is given as a single injection post surgery, could overcome the major drawbacks such as bleeding and the need for extensive patient monitoring associated with current anti-coagulant therapy.
TB-403 - Anti-cancer: Positive results announced in Phase Ia study with TB-403 and start of Phase Ib study in late stage cancer patients. The first Phase l study with TB-403 showed that it was well tolerated, with a pharmacokinetic profile which would allow it to be developed as a treatment for cancer. TB-403 is currently in a Phase Ib trial which studies its tolerability, pharmacokinetics and pharmacodynamics in patients with advanced cancer.
Corporate highlights
Major partnering deal: In June 2008, ThromboGenics and its co-development partner BioInvent signed a strategic alliance deal with Roche for its novel anti-cancer agent, TB-403 (anti-PIGF). Under the terms of the agreement ThromboGenics and BioInvent shared 60/40, an upfront payment of €50 million and could potentially share up to €450 million in milestone payments as well as double digit royalties on the same basis. TB-403 is being developed as an anti-cancer agent, and is currently in a Phase Ib clinical trial. TB-403 acts selectively by inhibiting the growth of new blood vessels in cancer tissue but not in normal tissue.
Financial Highlights
• In 2008, ThromboGenics revenue amounted to €30.4 million. This much higher level of revenue is due to Roche’s upfront payment following the signed deal on TB-403. Operating expenses for the full year were €19.2 million, the vast majority of which were due to R&D expenses related to the Company’s clinical development programs. The net profit over the reported period amounts to € 12.1 million against a loss of €16.0 million over the full year 2007.
• The Company expects to see an increase in its operating expenses in 2009 as it invests in the Phase III clinical program for microplasmin in back of the eye disease. This program began in January 2009.
• As of 31 December 2008, ThromboGenics had €58.9 million in cash and investments, including €28.6 million in short term, near liquid investments. This compares to € 40.1 million in cash and € 6.7 million in short term investments at December 31, 2007. This level of cash resources is expected to allow ThromboGenics to drive forward its operational plans for the next two years.
Patrik De Haes, CEO of ThromboGenics, commenting on today’s announcement, said: “ThromboGenics had a very successful 2008, making excellent progress with its development pipeline and reporting a pre-tax profit for the period. The recent start of our Phase III program with microplasmin in patients with back of the eye disease is a major milestone for the Company. Our decision to initiate this pivotal clinical program was driven by the excellent clinical Phase II data that we have generated, combined with our strong financial position. This is the result of the €30m upfront payment we received as part of our major strategic licensing deal for TB-403 with Roche, signed in June 2008. We are also making good progress with TB-402, a novel long acting anti-coagulant which we believe has advantages over currently marketed products. As ThromboGenics continues to transform itself into a late-stage development company, I am confident that we have all the tools needed to ensure our corporate success.”
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and development of biopharmaceuticals for the treatment of eye disease, vascular disease and cancer. The Company’s lead product Microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal indications and as a potential therapy for stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at www.thrombogenics.com. Important information about forward-looking statements Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report.
