INTERIM REPORT ON BIOTIE THERAPIES CORP. JANUARY 1 - JUNE 30, 2008

 

 

 

- In January Lundbeck acquired the United Kingdom and Ireland rights for nalmefene from Britannia Pharmaceuticals (now part of STADA Group, headquartered in Germany). Following the new agreement Lundbeck has worldwide rights for nalmefene, excluding North America, Mexico, Turkey, and South-Korea.

 

- In June Biotie announced top-line data from the first-in-man clinical study with its fully human VAP-1 monoclonal antibody. The data from the study support proceeding to clinical studies with repeated doses of the antibody.

 

- The net loss in January - June stood at EUR 3.3 million (net income in 2007 EUR 1.6 million). Cash flow in January - June from operating activities was EUR -5.8 million (EUR -2.9 million in 2007).

 

- Revenue for January - June stood at EUR 3.2 million (EUR 5.2 million in 2007) and earnings per share was EUR -0.04 (EUR 0.02 in 2007).

 

- The company's liquid assets amounted to EUR 23.0 million as at June 30, 2008 (EUR 30.2 million as at June 30, 2007).

 

 

- The net loss in April - June stood at EUR 1.3 million (net income in 2007 EUR 2.7 million). Cash flow in April - June from operating activities was EUR -2.5 million (EUR -0.3 million in 2007).

 

- Revenue for April - June stood at EUR 1.8 million (EUR 4.6 million in 2007) and earnings per share was EUR -0.01 (EUR 0.03 in 2007).

 

 

 

Biotie is a drug development company focusing on dependence disorders, inflammatory diseases and thrombosis.

 

 

Drug development projects:

 

Nalmefene program

 

In January, Lundbeck acquired the United Kingdom and Ireland rights for nalmefene from Britannia Pharmaceuticals (now part of STADA Group, headquartered in Germany). Following the new agreement Lundbeck has worldwide rights for nalmefene, excluding North America, Mexico, Turkey, and South-Korea.

 

Biotie-Lundbeck license agreement terms were amended due to Lundbeck acquiring the United Kingdom and Ireland rights. Under the terms of the amended agreement, Biotie is now eligible for up to EUR 82 million in upfront and milestone payments (previously up to EUR 80 million) plus royalty on sales. Of the EUR 82 million, Biotie has already received an execution fee of EUR 12 million from Lundbeck.

 

To maximise nalmefene's potential in the treatment of alcoholism Biotie and Lundbeck have jointly decided to seek marketing authorisation simultaneously in all 27 EU member states via the centralized procedure. To this end, Lundbeck plans to further strengthen the existing nalmefene registration dossier in its alcoholism indication with additional phase III clinical studies before submitting the marketing authorisation application. The studies are expected to start in 2008. Biotie will participate in financing some of the clinical development costs.

 

 

VAP-1 antibody program

 

Top-line data from the first-in-man study with Biotie's fully human VAP-1 monoclonal antibody BTT-1023 were reported in June 2008. The study was conducted in a clinical pharmacology unit in the United Kingdom and investigated the safety, tolerability and pharmacokinetic characteristics of single intravenous doses of BTT-1023 in healthy volunteer subjects.

 

A total of 35 subjects, of whom 29 received BTT-1023, were enrolled into the placebo-controlled study. BTT-1023 was generally well tolerated and no serious adverse events were reported in the study. Among the five subjects who received the highest dose, facial flushing was reported by two subjects with accompanying facial oedema in one of the two. These were reported during or shortly after the infusion and are not uncommon events in association with intravenous administration of therapeutic protein drugs. No cytokine release or fever was observed in any subject. All adverse events were fully reversible and required no particular intervention.

 

The data from the study support proceeding to clinical studies with repeated doses of the antibody. These studies are expected to be carried out in rheumatoid arthritis and psoriasis patients and will aim to establish appropriate dosing regimens for subsequent therapeutic studies and provide initial information on the therapeutic potential of BTT-1023. The studies are expected to start in the end of 2008.

 

In November 2006, Biotie and Roche signed an option agreement for Biotie's fully human antibody program targeting Vascular Adhesion Protein-1 (VAP-1) in inflammatory diseases.

 

Under the terms of the agreement, Roche has paid an option initiation fee of EUR 5 million, which grants Roche an exclusive option right to an exclusive, worldwide license agreement for Biotie's fully human antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, and Australia. The initial option right will end upon completion of Phase I. Roche may extend the option right to later development points by paying additional fees. Biotie will retain all rights to the program until a license is granted to Roche.

 

Inhibiting VAP-1 reduces inflammation by regulating the migration of leukocytes, or white blood cells, to inflamed tissues. Pathological accumulation of white blood cells in tissue is a common feature in many autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis, and psoriasis.

 

Co-operation with Seikagaku Corporation proceeded as planned.

 

Pre-clinical programs

 

Pre-clinical programs (VAP-1 SSAO small molecule inhibitor program and alfa2beta1 integrin inhibitor program) progressed as planned. In the bioheparin program the company continued to look for a partner to finance the future development of the program. To date, partnering efforts have not been successful.

 

 

Revenue for the reporting period 1.1.-30.6.2008 was EUR 3.2 million. Revenue consisted of periodization of the signing fees of the licensing agreements signed with Seikagaku Corporation in 2003 and with Somaxon Pharmaceuticals in 2004, periodization of the option fee of the option agreement signed with Roche in 2006 as well as periodization of the execution fee of the licensing agreement signed with Lundbeck that entered into force in May 2007. No new milestones or signing fees were received during the reporting period.

 

Revenue for the period 1.1.-30.6.2007 consisted of periodization of the signing of the licensing agreement signed with Seikagaku Corporation in 2003 and periodization of the signing fee of the licensing agreement in nalmefene project signed with Somaxon Pharmaceuticals in 2004 and periodization of the option fee of the option agreement signed with Roche in 2006 as well as periodization of the execution fee of the licensing agreement signed with Lundbeck that entered into force in May 2007. The revenue was in total EUR 5.2 million. Payment of EUR 2.0 million was received from Lundbeck during the period.

 

Revenue for April - June 2008 amounted to EUR 1.8 million (EUR 4.6 million in 2007) consisting of periodizations described above.

 

 

The net loss for the reporting period was EUR 3.3 million (net income in 2007 EUR 1.6 million). Research and development costs for the period amounted to EUR 5.2 million. The corresponding figure for the previous year was EUR 3.5 million.

 

The net loss in April - June was EUR 1.3 million (net income in April - June 2007 EUR 2.7 million). Research and development costs in the second quarter amounted to EUR 2.8 million (EUR 2.1 million in 2007)

 

Patent costs have been booked as expenses.

 

 

Biotie's equity ratio was -57.6 % on June 30, 2008 (-25.5 % in 2007). Cash and cash equivalents totaled EUR 23.0 million on June 30, 2008 (EUR 30.2 million in 2007).

 

The company has invested its liquid assets into bank deposits during the second quarter 2008. Funds are reported in "investments held to maturity". Deposits with maturity less than 3 months are reported in the "cash and cash equivalents". Previously the funds were invested in money market funds.

 

In January 2008, The Finnish Funding Agency for Technology and Innovation (Tekes) granted EUR 1.7 million additional funding for Biotie Therapies' integrin alpha2beta1 inhibitor program for thrombosis. The R&D funding granted covers drug development costs of the project from July 2007 to December 2009.

 

The funding granted is in the form of loan and it covers 50 per cent of the costs of the project. The loan will be paid to Biotie against reported realised costs. In order to receive the full amount of granted financing, Biotie must show a total expenditure of EUR 3.4 million in the project.

 

 

The shareholders' equity (FAS) of the company is less than half of the company's share capital when capital loans are not included in shareholders' equity. Shareholders' equity and capital loans add up to EUR 14.3 million.

 

Annual General Meeting was held on March 28, 2008 and considered measures relating to the level of shareholder's equity. It was resolved that no special measures are necessary at this point in time.

 

 

The cash flow from operations was EUR -5.8 million (in 2007 EUR -2.9 million The company's investments during the reporting period amounted to EUR 109 thousand (EUR 10 thousand in 2007).

 

The cash flow from operating activities in April - June was EUR -2.5 million (EUR -0.3 million in 2007). Investments during the second quarter amounted to EUR 92 thousand (EUR 3 thousand in 2007).

 

 

 

During the reporting period, the company's personnel was on average 35 (35 in 2007, 39 in 2006) and at the end of the reporting period 36 (33 on June 30, 2007 and 36 on June 30, 2006).

 

 

 

*) The company has in its possession 819.000 of its own shares. Relating to the company's option programs, the company has signed a stock lending agreement with EVLI Bank in January, 2007. Pursuant to this program, the number of the company's own shares in its possession may be temporarily less than 819,000.

 

 

 

Biotie's strategic risks are related to the technical success of the drug development programs, regulatory issues, the strategic decisions of its commercial partners, ability to obtain and maintain intellectual property rights for its products, validity of its patents, launch of competitive products and the development of the sales of its products and availability of capital. For example, even though the commercialisation and collaboration agreements on the company's product development projects have been concluded, there can be no assurance that the contracting partner will act in accordance with the agreement, the authorities will approve the product under development or the approved product will be commercialised. The development and success of the company's products depends on third parties.

 

The operational risks include dependency of key personnel, assets and dependency on partners' decisions.

 

 

 

- Lundbeck is expected to start additional phase III studies with nalmefene in its alcohol indication in 2008.

 

- Due to Biotie having two programs in the clinical development phase the operating costs are expected to increase to a somewhat higher level for 2008 than in 2007.

 

- Revenue in 2008 is estimated to be approximately EUR 5 to 6 million and consists of periodization of already received payments based on established revenue recognition principles. The company is not expecting new milestone payments based on existing agreements in 2008.

 

 

 

The interim report has been prepared in accordance with IAS 34, Interim Financial Reporting. Biotie has applied the same accounting principles as in the closing of year 2007.

 

This interim report is unaudited.

 

Biotie's interim report for January - September will be published on October 24, 2008.

 

In Turku, August 8, 2008

 

Biotie Therapies Corp.

 

Board of Directors

 

 

For further information, please contact:

 

Timo Veromaa, President and CEO, Biotie Therapies Corp.

tel. +358 2 274 8901, e-mail: timo.veromaa@biotie.com

 

www.biotie.com

 

Distribution:

OMX Nordic Exchange Helsinki

Main Media

 

 

APPENDICES TO THE FINANCIAL STATEMENTS

 

Income statement

Balance sheet

Statement of changes in shareholders' equity

Cash flow statement

Key figures

 

 

 

 

 

 

 

 

STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY

 

Attributable to equity holders of the parent company

 

 

 

 

 

 

 

 

 

 

Related party transactions

 

There have not been material changes within the related party transactions in 2008.

 

 

 

 

Formulas for the Calculation of the Financial Ratios

 

 

Return on equity, %

Profit (loss) before extraordinary items - taxes

--------------------------------------------------------------- x 100

Shareholders' equity

 

Return on capital employed, %

Profit (loss) before taxes + interest expenses and other financial expenses

--------------------------------------------------------------- x 100

Balance sheet total - non-interest bearing liabilities

 

Equity ratio, %

Shareholders' equity

--------------------------------------------------------------- x 100

Balance sheet total - advanced received

 

Gearing, %

Interest bearing liabilities - cash and cash equivalents

-------------------------------------------------------------- x 100

Shareholders' equity

 

Earnings per share (EPS)

Profit before extraordinary items, appropriations and taxes - minority interest - taxes

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Adjusted average number of outstanding shares during the period

 

Shareholders' equity per share

Shareholders' equity

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Adjusted average number of outstanding shares at the end of the period