Orexo AB (publ) - Interim Report January-September 2009

• Press Release
• Source: Orexo
• On 11:07 am EST, Tuesday November 10, 2009

UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News:

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Orexo AB (publ) (STO:ORX) – Interim report January-September 2009

Key events during the period

• Net revenues amounted to MSEK 208.2 (141.2).
• The loss after tax was MSEK 40.1 (loss: 88,6).
• The loss per share was SEK 1.78 (loss: 4.10).
• Cash and cash equivalents at the end of the quarter totaled MSEK 107.1 (195.7).
• In March, the US Food and Drug Administration (FDA) approved Orexo’s Edluar product for the treatment of short-term insomnia. The approval meant that Orexo received a milestone payment of MUSD 5 from Meda.
• In February, Orexo signed an exclusive development agreement with Novartis. The agreement covers the joint development of Orexo’s OX17 program for the treatment of gastroesophageal reflux disease (GERD).
• In February, Orexo acquired the British drug delivery company PharmaKodex Ltd. The acquisition strengthens Orexo’s strategy of developing unique drugs based on well-established, effective substances.

Third quarter

• Net revenues amounted to MSEK 63.7 (61.0).
• The loss after tax was MSEK 9.5 (profit: 1.9).
• The loss per share was SEK 0.41 (profit: 0.09).
• Orexo announced that its partner Meda, launched Edluar in the US.
• Orexo signed an exclusive global license agreement with a Novartis affiliate covering the development and commercialization of a new product based on Orexo’s OX17-program. Orexo will receive milestone payments upon major development achievements, and will be eligible for further milestone payments upon the attainment of certain sales targets. In addition, Orexo will receive royalties on future sales of the product.
• Orexo announced that its partner, ProStrakan, has submitted a registration application for Abstral to the US Food and Drug Administration (FDA).

CEO’s comments:

Improved operating result and higher royalty revenues During the period, we reached key goals in Orexo’s progress towards becoming a profitable pharmaceutical company. The operating result improved, due largely to higher license revenues. Royalty revenues from our Abstral and Edluar products totaled MSEK 5.5 during the third quarter, representing a threefold increase compared with the preceding quarter. Sales of Abstral recorded a robust trend in Europe. Edluar was launched in the US during the third quarter by our partner Meda.

High growth in royalty revenues will be the key component in attaining sustainable profitability and we have every confidence in our products. Abstral has recently been launched in Spain and additional European launches are expected. In the US, the product will be launched during the second half of 2010, provided that the approval process progresses as planned.

Licensing agreement with Novartis In August we signed a global licensing agreement for OX17 with Novartis. The licensing agreement will start to generate milestone payments in connection with the commencement of Phase III studies. Thereafter, Orexo will receive milestone payments upon major development achievements, and will be eligible for further milestone payments upon the attainment of certain sales targets. In addition, Orexo will receive considerable royalties on Novartis’ future sales of the product. We continue to have a great focus on business development in order to close additional revenue-generating partnerships with pharma partners.

Lower operating expenses in 2010 Since Abstral and Edluar have been registered and launched, the costs related to those products will decrease significantly next year. During the quarter, we also completed the previously announced cost-cutting program. Overall, this leads us to forecast operating expenses for 2010 in the range of MSEK 200 to 220.

Solid growth in revenues – combined with lower costs – indicate that we are increasingly approaching the stage at which we will become a pharmaceutical company with sustainable profitability.

Torbjörn Bjerke
President and CEO

For the entire report, see enclosed link to pdf.

Note
Orexo AB publ. discloses the information provided herein pursuant to the Securities Markets Act. The information was provided for public release on November 10, 2009, at 08:00 CET. This report has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall take precedence.

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Orexo AB (publ)
Torbjörn Bjerke, President and CEO
Tel: +46 708 66 19 90
E-mail: torbjorn.bjerke@orexo.com
or
Claes Wenthzel, Executive Vice President and CFO
Tel: +46 708 62 01 22
E-mail: claes.wenthzel@orexo.com
or
Johan Andersson, Investor Relations Manager
Tel: +46 702 10 04 51
E-mail: johan.andersson@orexo.com