Orexo AB (publ) – Interim report January-September 2008

10 November 2008 · Interim Report · Regulatory

Key events during the period
• Net revenues amounted to MSEK 141.2 (21.7)
• A loss of MSEK 88.6 (loss: 128.6) was reported after tax
• Earnings per share amounted to a loss of SEK 4.10 (loss: 9.24)
• Cash flow from operating activities was negative in an amount of MSEK 94.2 (neg. 131.8)
• The exclusive world rights to two Orexo pharmaceuticals, Sublinox™ (OX22) and OX-NLA, were licensed to Meda AB.
• Abstral®/Rapinyl was approved for registration in Europe by the EMEA’s Committee for Medicinal Products for Human Use (CHMP).


Third quarter of 2008
• Net revenue amounted to MSEK 61.0 (6.5). A profit of MSEK 1.9 (loss: 34.1) was reported for the third quarter, corresponding to earnings per share of SEK 0.09 (loss: 2.44)
• Cash flow from operating activities was negative in an amount of MSEK 51.3 (neg. 34.3)
• Abstral® was approved for marketing in the UK
• Orexo announced licensing agreements for Abstral®/Rapinyl with ProStrakan and changed partners in the US
• The registration application for SublinoxTM (OX22) was accepted after the first evaluation as complete for final evaluation by the Food and Drug Administration (FDA) in the US
• Orexo initiated a clinical Phase II program for OX914 – a new product candidate for treatment of inflammatory respiratory diseases
• Orexo and Boehringer Ingelheim extended their research agreement regarding OX-MPI


Key events after the closing date
• On October 31, the rights for Rapinyl in North America were transferred from Orexo’s previous partner Endo Pharmaceuticals to ProStrakan Ltd. In conjunction with the transfer, Orexo received MUSD 0.75 from Endo according to the previous agreement. Orexo also received MUSD 2.6 in compensation from Endo to finance the Phase III studies now in progress. In addition, ProStrakan will pay MUSD 2 to Orexo in conjunction with the takeover.


Torbjörn Bjerke, President and CEO, comments:
Orexo continued its strong development and we took further steps during the past quarter towards our goal of developing Orexo into a profitable pharmaceutical company. The most important events during the third quarter and until today were:

• Launch of Abstral® in Sweden and the start of sales.
• Approval of Abstral® for marketing in the UK. The decision was announced earlier than anticipated, and the launch of Abstral® in Europe’s largest market can now take place toward the end of the year.
• We are satisfied that the transfer of the rights to Rapinyl in North America took place earlier than planned. We and our partner ProStrakan will now conclude the Phase III studies, which are expected to be completed in December. At the same time, we are preparing the submission of the registration application and marketing of Rapinyl in North America.


For the entire report, see enclosed link to pdf.


For further information, please contact
Torbjörn Bjerke, President and CEO, tel: +46 18 780 88 12, e-mail: torbjorn.bjerke@orexo.com
Claes Wenthzel, Vice President and CFO, tel: +46 18 780 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 November 10, 2008 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.