Orexo AB (publ) – Year-end Report January–December, 2008

17 February 2009 · Annual Financial Statement · Regulatory

The year in brief
• Net revenues increased to MSEK 233.3 (76.8)
• The loss after tax was MSEK 103.1 (loss: 172.6)
• Earnings per share amounted to a loss of SEK 4.77 (loss: 11.42)
• The exclusive global rights to two of Orexo’s drugs – Sublinox™ and OX-NLA – were outlicensed to Meda AB.
• Abstral was approved for registration in Europe by the EMEA’s Committee for Medicinal Products for Human Use (CHMP).
• Abstral was approved for marketing in Sweden, Germany and the UK.
• Orexo announced licensing agreements for Abstral with ProStrakan and changed its US partner, from Endo Pharmaceuticals to ProStrakan.
• The registration application for Sublinox was accepted by the US Food and Drug Administration (FDA) after an initial evaluation as complete for substantive review.
• Orexo initiated the clinical phase II program for OX914 – a new product candidate for the treatment of inflammatory respiratory diseases.
• Orexo and Boehringer Ingelheim extended their research collaboration for OX-MPI.

Fourth quarter, 2008
• Net revenues rose to MSEK 92.1 (55.1)
• The after-tax loss was MSEK 14.4 (loss: 44.0)
• Earnings per share amounted to a loss of SEK 0.67 (loss: 2.47)

Key events after the year-end
• Orexo signed an exclusive development agreement with a large healthcare company, providing for joint development of Orexo’s OX17 program for gastroesophageal reflux disease (GERD).
• Orexo and the Chinese pharmaceutical company NovaMed Pharmaceuticals signed a distribution agreement that grants NovaMed exclusive rights to market and sell AbstralTM, Orexo’s product for the treatment of breakthrough cancer pain, in the People’s Republic of China.


Torbjörn Bjerke, President and CEO, comments:

2008 was one of the most active and operationally successful years so far for Orexo. We have confirmed a strategic direction and are on our way to become a profitable pharmaceutical company. A number of factors contributed to Orexo's success, including the approval of AbstralTM in Europe, successful clinical trials, a major deal with Meda covering two of our products, and the change of partner for Rapinyl/AbstralTM in North America, with increased royalty rates.

The year 2009 may be an even more eventful year for Orexo since we, together with our partner Meda, expect a decision from the US Food and Drug Administration (FDA) in respect of SublinoxTM – designed to treat sleep disturbances. We will also submit a registration application for Rapinyl/AbstralTM to the FDA. We expect higher sales of AbstralTM, as the product has now been launched in Sweden, Germany and the UK, with more territories expected in 2009. Also during the current year, the focus will be on identifying new business partners and strict cost control. Orexo has sufficient cash liquidity to permit it to continue pursuing operations on the basis of the same business model up to and including 2010 without additional financing.

For the entire report, see enclosed link to pdf.

For further information, please contact:
Torbjörn Bjerke, President and CEO, tel: 018-780 88 12, e-mail: torbjorn.bjerke@orexo.com
Claes Wenthzel, Executive Vice-President & CFO, tel: 018-780 88 44, e-mail: claes.wenthzel@orexo.com


Note
Orexo AB Publ. discloses the information provided herein pursuant to the Securities Markets Act. The information was provided for public release on February 17, 2009 at 08:00 a.m. CET. This report has been prepared in both Swedish and English. In case of variation in the content of the two versions, the Swedish version shall take precedence.