Interim Report January-December 2011

31 January 2012 · Annual Financial Statement · Regulatory

Unless otherwise stated in this report, all data refers to the group. Figures in parentheses are for the corresponding periods in 2010.

POSITIVE DEVELOPMENT IN ABSTRAL® SALES AND OREXO’S PROPRIETARY PROGRAMS WHILE THE OX-CLI AND OX-ESI PROJECTS ARE ABORTED

During the year

  • Net revenues amounted to 199.6 MSEK (210.5).
  • The loss after tax was MSEK -392.0 (-89.2).
  • Impairment of acquired development related to the OX-CLI and OX-ESI projects amounted to MSEK 233
  • Operating income adjusted for impairment of acquired development amounted to MSEK ‑120.3 (‑56.0).
  • Cash flow from operating activities amounted to MSEK -117.2 (-43.0).
  • The loss per share amounted to SEK -14.43 (-3.81).
  • Cash and cash equivalents at the end of the year, amounted to MSEK 246.9 (MSEK 135.8).
  • Royalty revenues from Abstral® sales increased to MSEK 70.5 (42.2).
  • Abstral was approved and introduced in the US and Canada.
  • A new share issue worth approximately MSEK 245, before transaction costs, was completed. ATP and Abingworth became new shareholders and Novo A/S became the largest shareholder.
  • All three development programs, OX219, OX51 and OX27 advanced according to plan and positive results were reported from clinical studies.

After the period

  • Negotiations regarding the collaboration with Janssen Pharmaceuticals, Inc. on OX-CLI and OX-ESI ended, and hence Orexo aborts the project activities.

Fourth quarter

  • Net revenues amounted to MSEK 56.7 (109.1).
  • Cash flow from operating activities amounted to MSEK -46.9 (-29.2).
  • The loss after tax was MSEK -271.0 (2.2).
  • The loss per share amounted to SEK -9.07 (0.09).

 

CEO comments

“The strong sales growth for Abstral® continued in the fourth quarter, which meant that the royalty revenue from this pain product increased by 67 per cent in 2011 to MSEK 70.5. We see continued growth in most markets in Europe and despite increased competition, Abstral succeeds in maintaining, and in many markets strengthening its market position in Europe.

In the U.S. the FDA decided in December to approve a common risk management system for all fast-acting fentanyl products. The new system will come into effect in March 2012, which means that Abstral, for the first time, will be able to compete on equal terms with other fast acting fentanyl products in the U.S. market.

It was obviously a disappointment to us that our collaboration on two projects in the arachidonic acid field with Janssen Pharmaceuticals, Inc. (formerly OMJ) has been ended. Unfortunately, we lack the funds to continue on our own to develop the OX-CLI and OX‑ESI projects and have therefore decided to close them down.

In 2011 we announced positive results from a Phase I study with OX219, for the treatment of opioid dependence. The study results confirmed the final commercial formulation, and dose for the product. We are advancing the program and in the first half of 2012 pre-registration studies will be initiated.

We end 2011, showing that all three of our proprietary development programs are advancing towards the market according to plan. Most promising is the initiation of pre-registration studies for OX219 in the first quarter of 2012. Altogether, with the progress in our projects, a very good staff and a management team with the right skills, we are as planned, on our way to become a successful specialty pharma company.”

Anders Lundström

President and CEO

 
Conference call
CEO Anders Lundström and CFO Carl-Johan Blomberg will be presenting the report at a conference call at 10:00 am CET today.
The presentation is available via link and on the company website. Internet: http://livecast.se/stockontv/120131/orexo/
Telephone: +44 (0) 20 3003 2666 - Standard International Access; 08-50520424 – Stockholm (toll free);
0808 109 0700 - England (toll free); 1 866 966 5335 - USA (toll free)

 
For further information, please contact:
Anders Lundström, President and CEO, Tel: + 46 (0)706-67 22 66, E-mail: anders.lundstrom@orexo.com
Carl-Johan Blomberg, CFO, Tel: +46 (0)706-33 67 11, E-mail: carl-johan.blomberg@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 January 31, 2012, at 8:30 a.m. CET. This report has been prepared in both Swedish and English. In the event of any discrepancy in the content between the two versions, the Swedish version shall take precedence.