Orexo AB reports year-end 2009 financial results

CisionFeb 17 2010

Orexo AB (publ)(STO:ORX) –

Year-end Report January–December 2009

Key events during the year

• Net revenues totaled MSEK 236.1 (233.3).

• The loss after tax was MSEK 98.1 (loss: 103.1).

• The loss per share amounted to a loss of SEK 4.32 (loss: 4.77).

• Cash and cash equivalents at year-end totaled MSEK 87.4 (188.2).

• Abstral was launched in UK, Germany, France, Spain and Greece.

• In March, the FDA approved Orexo’s product Edluar for the short-term treatment of insomnia. The approval resulted in Orexo receiving a milestone payment of MUSD 5 from Meda.

• In August, Orexo signed an exclusive license agreement with Novartis. The agreement covered 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 to develop drugs based on well-established, effective substances.

Fourth quarter

• Net revenues totaled MSEK 27.9 (92.1).

• The net loss after tax was MSEK 58.0 (loss: 14.4).

• The loss per share was SEK 2.48 (loss: 0.67).

• Orexo’s partner, ProStrakan Group plc, announced that the registration application for Abstral in the US had been accepted for final review by FDA.

• Royalty revenues from Abstral in Europe rose to MSEK 9.9 compared to MSEK 3.3 in the third quarter.

Torbjörn Bjerke, President and CEO, comments:

Sales of Abstral continue to show robust growth, with royalty revenues rising sharply during the fourth quarter – up threefold from the preceding quarter. Our partner, ProStrakan, launched during 2009 Abstral in UK, Germany, France, Spain and Greece, and product launches in additional markets are imminent. Sales growth confirms that there is a substantial medical requirement in the case of cancer patients suffering from breakthrough pain.

During the third quarter, our partner ProStrakan filed a registration application for Abstral in the US. The FDA accepted the registration application as complete for evaluation during the fourth quarter and, if the approval process proceeds on schedule, the product may be launched in the US during the latter half of 2010.

Orexo’s primary focus for 2010 is commercialization, sales and marketing as well as continuing cost control. Rising royalty revenues, combined with lower costs, mean that we are approaching our goal of being a pharmaceutical company with sustainable profitability. We expect our operation cost to be about MSEK 200-220.