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


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

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.

Pièces jointes

02162623.pdf