Interim report, January-September 2011

Uppsala, November 9, 2011 - Orexo´s proprietary development programs advance

For the period

  • Net revenues totaled to MSEK 142.9 (101.4).
  • Loss after tax was MSEK 121.0 (loss: 91.4).
  • Cash flow from operating activities showed a loss of MSEK 70.3 (loss: 13.7).
  • Loss per share was SEK 4.61 (loss: 3.90).
  • Cash and cash equivalents at the end of the period totaled MSEK 294.3 compared with MSEK 135.8 at year end.
  • Royalty revenues from Abstral® sales rose to MSEK 51.3 (30.3).
  • Completion of a new share issue amounting to some MSEK 245 before transaction costs.
    ATP and Abingworth became new shareholders and Novo A/S is the largest shareholder.
  • A Phase I study of OX219 for the treatment of opioid dependence showed positive results.
  • Positive data from the first clinical study of OX27 for the treatment of breakthrough pain in cancer patients.
  • The insomnia-treatment Sublinox (Edluar), licensed to Meda, was approved for sales in Canada.
  • Wagner Analysen Technik GmbH in Germany was acquired through the subsidiary Kibion AB.
  • The management group was strengthened by the recruitment of a new Chief Financial Officer and Chief Commercial Officer.

Following the period

  • A Chief Scientific Officer was appointed.

Third quarter

  • Net revenues totaled MSEK 46.2 (35.9).
  • Cash flow from operating activities was a negative MSEK 39.1 (neg: 25.0).
  • Loss after tax was MSEK 55.9 (loss: 28.5).
  • Loss per share was SEK 1.87 (loss: 1.22).

Teleconference
CEO Anders Lundström and CFO Carl-Johan Blomberg will present the report at a teleconference today at 10:00 a.m. CET.
Presentation slides are available by link and on the website. Internet: http://livecast.se/stockontv/111109/orexo/
Telephone: +44 (0) 20 3003 2666 - Standard International Access; 08-50520424 – Stockholm Toll Free; 0808 109 0700 - UK Toll Free; 1 866 966 5335 - USA Toll Free

CEO’s comments
“It is interesting to follow the strong sales growth of Abstral®. During the first nine months of the year, our royalty revenues from the pain product rose 69 percent to MSEK 51.3. The product continues to capture market shares in Europe and sales have increased by more than 60 percent year to date. In September, Abstral was launched in the Netherlands and it has also been approved for marketing in Russia, where our partner is preparing a launch in the coming year.

In the US, all fast-acting fentanyl products will be sold under REMS program from the end of the first quarter, 2012. Only then will Abstral compete on equal terms with other products, as it has so successfully done in Europe.

The development of our proprietary products is advancing at rapid pace. During the third quarter, we obtained positive results from a study of OX219 which is developed for the treatment of opioid dependence. The results have confirmed our commercial formulation and dose. Since our registration application may be based on data from an already approved drug, our clinical studies will not be as extensive. This is but one of the many advantages to our strategy of developing new patentable products based on existing successful therapies in clinical use.

Our two other proprietary programs are proceeding according to plan and during the fourth quarter, we are expecting data from our next study of OX27, which is being developed for breakthrough pain in cancer patients.

Orexo’s new orientation towards becoming a specialty pharmaceutical company places new demands on our organization. The strengthening of the executive management is the next step in our strategy to create profitability focusing on our three proprietary programs. Consequently, during the third quarter, we recruited Peter Edman as Chief Scientific Officer and Nikolaj Sørensen as Chief Commercial Officer (CCO), both new key positions.
Peter Edman, with his solid scientific background and long experience from all the phases of drug development, is well-suited to shoulder the overall responsibility of Orexo’s R&D. The position of CCO is also central, since Orexo’s commercial operations will be expanded significantly.
Nikolaj Sørensen joins us from Pfizer, where he was responsible for the marketing and sales of a leading pain product in Europe and Canada. In addition, he has also been Managing Director for Pfizer in Sweden. To make the management team complete we also have a new highly-qualified CFO in place, Carl-Johan Blomberg, who is also responsible for Investor Relations and IT.

During the final quarter, we will continue the development of our proprietary development programs, both by clinical and commercial planning. Preparing a commercial launch is a substantial undertaking that spans several years and is established gradually, bringing Orexo closer to becoming a leading specialty pharmaceutical company, step-by-step.”

Anders Lundström
President and CEO

For the entire report, see enclosed link to pdf.

For further information, please contact:
Anders Lundström, CEO, tel: +46 (0)706 67 22 66, e-mail: [email protected]
Carl-Johan Blomberg, CFO, tel: +46 (0)706 33 67 11, e-mail: [email protected]

Note
Orexo AB publ discloses the information provided herein pursuant to the Securities Markets Act. The information was provided for public release on November 9, 2011, at 8:00 a.m. 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 prevail.