Interim report, January-September 2012

OREXO CLOSER TO LAUNCHING ZUBSOLV™ (OX219) – NEW TREATMENT OF OPIOID DEPENDENCE

During the interim period

  • Net revenues amounted to MSEK 242.7 (142.9).
  • Revenues from launched products increased by 105 percent to MSEK 190.1 (92.8).
  • EBITDA amounted to MSEK -52.5 (-76.9 ).
  • Earnings after tax were MSEK -63.6 (-121.0).
  • Earnings per share were SEK -2.14 (-4.61).
  • Cash flow from operating activities amounted to MSEK 105.5 (-70.3).
  • Cash and cash equivalents amounted to MSEK 306.2 (294.3).
  • Fixed royalty related to Abstral® according to the new agreement amounted to MSEK 59.4 (17.7) during third quarter.
  • In September, an application for registration of Zubsolv (OX219) was submitted to the FDA five months earlier than planned.
  • During the third quarter Orexo performed a buyback of the company’s own shares, in total amounting to MSEK 53.

After the interim period

  • In October Guggenheim Securities LLC was retained to explore strategic alternatives for commercialization in the US.

CEO’s comments
During the third quarter we reached an important milestone when we submitted an application for the registration of Zubsolv™ (OX219) to the U.S. Food and Drug Administration, FDA. Zubsolv is a product for the treatment of opioid dependence. Thanks to a great effort by our co-workers, we managed to do this five months earlier than originally planned, which I am very impressed by.

There is a considerable market potential for Zubsolv in the USA, in a fast growing market. Zubsolv has several important patient friendly properties which make the tablet easy to use (such as rapid dissolution and smaller tablet size). We believe Zubsolv to be competitive product and anticipate that we can take considerable market shares and achieve sales of up to 500 million dollars a year. The launch of Zubsolv is planned for the third quarter of 2013. In order to strengthen Zubsolv’s competitiveness, we have initiated a new development program to further differentiate our product from those of our competitors.

However, besides the very interesting prospects with Zubsolv, as previously announced we entered into a new agreement with ProStrakan regarding Abstral® during the second quarter. The agreement has strengthened Orexo financially and we will regain the Abstral product rights in the USA during the first quarter of 2013. Our future presence in the USA will thus be based on Orexo offering the market two attractive products – Zubsolv and Abstral. We have engaged Guggenheim Securities, LLC as a financial advisor to explore different strategic alternatives for commercialization in the USA. Based on the analysis, we will announce at the end of this year how our commercialization plan for the USA will be designed. As a consequence of this ongoing strategic review, the buyback of shares will not be restarted now.

Anders Lundström
President and CEO


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 via the link and on the website. Internet: http://livecast.wehay.com/stockontv/121025/orexo/
Telephone:
+44 (0) 20 3003 2666 - Standard International Access; 020 089 6377 - Stockholm Toll Free; 0808 109 0700 - UK Toll Free; 1 866 966 5335 - USA Toll Free


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]


Please note
Orexo AB publ discloses the information provided herein pursuant to the Securities Markets Act. The information was provided for public release on October 25, 2012, 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.