Financial Statement 1 January - 31 December 2008
· BioInvent and ThromboGenics entered in June 2008 into a strategic license agreement with Roche for development and commercialisation of TB-403. BioInvent and ThromboGenics received an upfront payment of EUR 50 million. In addition, BioInvent and ThromboGenics could potentially receive up to EUR 450 million in milestone payments, as well as double digit royalties on potential product sales.
· Technology transfer under the terms of the alliance with Roche triggered in January 2009 a success fee of EUR 5 million to BioInvent and ThromboGenics.
· The first Phase l study with TB-403, for treatment of cancer, was completed in June 2008 and showed that TB-403 was safe and well tolerated. The study was conducted in healthy volunteers.
· The follow-up study, the second Phase I trial with TB-403, is a multi-dose study in patients with advanced cancer, and was started in June 2008.
· First approval has been granted to start clinical Phase II studies with product candidate TB-402 for the prevention of thrombosis. The planned study is a multicenter study in six countries, primarily in Central Europe, in patients who have undergone knee replacement surgery.
· All subjects in the Phase I programme with product candidate BI-204 for treatment of atherosclerosis have been enrolled and monitoring is completed. The project is developed in collaboration with Genentech.
· Product candidate BI-505, for treatment of cancer, has been granted orphan drug designation in Europe for the indication multiple myeloma. Equivalent status was previously granted in the US.
· In 2008 BioInvent entered into agreements with Bayer HealthCare and with a Japanese pharmaceutical company for research and development of antibody-based drugs.
· Net revenues for January - December 2008: SEK 252.1 million (143.4).
· Current investments together with cash and bank as of 31 December 2008: SEK 212.5 million (216.9).
· Cash flow from current operations and investment activities for January - December 2008: SEK -4.4 million (8.7).
· Profit after tax for January - December 2008 amounted to SEK 16.2 million (-16.1) and the profit after tax per share was SEK 0.29 (-0.31).+
Comments by the CEO
The year 2008 was successful for the company and our projects, both commercially and in terms of research. Of course the agreement with Roche, for the further development of TB-403 in cancer, accounts for the single largest breakthrough during the past year. The agreement ensured that the project received the expertise and resources necessary to take this very promising concept all the way to market. At the same time, the collaboration provided the company with a financial contribution that is of significance in the situation we are currently experiencing in the financial markets. It is also very satisfying to report that we already have received the first success-based milestone payment within the collaboration through the technology transfer to Roche. In addition, the Phase Ib program with seriously ill cancer patients is progressing according to plan and we expect that with time Roche will expand the clinical program with studies for a number of cancer indications.
In the Phase I study with BI-204 for the treatment of atherosclerosis, all individuals have now been included and monitoring is completed. In collaboration with Genentech we are now preparing for the next clinical development step, with a decision to start Phase II expected in the first half of 2009.
We have decided to conduct the first clinical trials with BI-505 in the United States. In preparation for this new and exciting step, we met with the US Food and Drug Administration (FDA) in early February to facilitate the approval procedure. Based on the feedback we received, we expect to be able to start the clinical program at the turn of the half-year 2009. We also recently received orphan drug designation for the indication multiple myeloma from the European Agency for the Evaluation of Medicinal Products (EMEA) - a classification that we already obtained from the FDA for the American market.
We expect to start the Phase ll studies with TB-402, for the prevention of thrombosis, in the near future. A long-acting coagulation inhibitor with favorable safety profile that is administered once in conjunction with the surgical procedure is expected to have good commercial prospects compared with the existing treatment, which requires daily dosage for several weeks with extensive patient monitoring. The Phase ll program is yet another important step to move the company forward in the the value chain. Financial performance in 2008 was also strong, with a profit of SEK 16 million. For the second consecutive year, we balanced our own cost and investment undertakings with revenues from large collaborative projects. Although we do not expect to achieve sustainable profitability until one of our product candidates is launched on the market, the agreements - and the revenues from these agreements - demonstrate the value generation in the projects.
Contact
Any questions regarding this report will be answered by:
BioInvent International AB (publ.)
Svein Mathisen, President & CEO, tel.+46 (0)46 286 85 67, mobile +46 (0)708 97 82 13
Cristina Glad, Executive Vice President, tel. +46 (0)46 286 85 51, mobile +46 (0)708 16 85 70.
College Hill
Holly Griffiths, Katja Stout and John McIntyre, tel. +44 (0)20 7457 2020, [email protected]
BioInvent is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects mainly within the areas of thrombosis, cancer and atherosclerosis.