Orexo AB (publ.) – Interim report, January-March 2009

Positive earnings and strong news flow

Period in brief
• Net revenues amounted to MSEK 114.9 (24.0).
• Profit after tax was MSEK 26.3 (-62.2).
• Earnings per share before dilution were SEK 1.20 (-2.88).
• Earnings per share after dilution were SEK 1.15 (-2.88).
• Cash and cash equivalents at the end of the period amounted to MSEK 148.2 (201.6).

Key events, first quarter of 2009
• The FDA (US Food and Drug Administration) approved Orexo’s EdluarTM product for the treatment of insomnia. The approval meant that Orexo received a milestone payment from Meda of MUSD 5.
• Orexo’s product AbstralTM was approved in France and Spain.
• Orexo entered license and distribution agreements that give exclusive rights to market and sell AbstralTM in China and Israel respectively.
• Orexo signed an exclusive development agreement with a large healthcare company. The agreement provides for joint development within Orexo’s OX17 program for the treatment of gastroesophageal reflux disease (GERD).
• Orexo acquired the UK drug delivery company PharmaKodex Ltd. The acquisition strengthens Orexo’s fundamental strategy of developing unique drugs based on well-established, effective substances.
• An experimental Phase IIa study involving OX914 was completed and the results indicated that oral treatment using OX914 did not show any statistically significant decrease in the patient’s symptoms for the treatment of rhinitis (hay fever).

Key events after the end of the period
• Orexo’s Annual General Meeting was held on April 23.


Positive earnings and strong news flow
The first quarter of the year may be summed up in a net profit of MSEK 26.3 and strong news flow for Orexo.

In early 2009, AbstralTM was launched in the UK and Germany, as well as being approved for sale in Spain and France. The launch in the UK and Germany is proceeding according to plan. We also signed agreements for AbstralTM in China and Israel, where our new partners NovaMed and Neopharm, respectively, will later launch the product.

In mid-March, the FDA approved our insomnia product EdluarTM in the US. Our partner Meda is now planning to launch EdluarTM on the US market during the second half of the year and we will receive royalties on Meda’s sale of EdluarTM. The approval of EdluarTM is an important milestone for Orexo and, thus, within 12 months we have secured approval for two proprietary developed drugs.
During the period, we also signed a development agreement for the OX17 program. Along with our partner, we plan to develop the product, while also continuing to negotiate a global exclusive license agreement. We also presented the results from an experimental Phase IIa study of OX914, which unfortunately did not produce positive results in treatment of rhinitis.

In February, we acquired the UK drug delivery company, PharmaKodex, which strengthens our business model to develop unique drugs based on well-established substances. The acquisition was accompanied by a number of attractive technologies and pharmaceutical projects, which may soon create value for Orexo.

Looking ahead, the objective is to accelerate revenues from our products which are being launched on additional markets. At the end of the quarter, Orexo had net cash and cash equivalents of MSEK 148.2 and in addition we received MUSD 5 (MSEK 41) in early April. We will continue to focus keenly on reducing our costs in order to further focus our business and strengthen our financial position.

Torbjörn Bjerke
President and CEO

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-post: torbjorn.bjerke@orexo.com
Claes Wenthzel, Executive Vice-President & CFO, tel: 018-780 88 44, e-post: claes.wenthzel@orexo.com
Johan Andersson, Investor Relations Manager, tel: 018-780 88 17, e-post: johan.andersson@orexo.com

Orexo AB Publ. discloses the information provided herein pursuant to the Securities Markets Act. The information was provided for public release on May 6, 2009 at 08:30 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.