Interim report January-June 2011

10 August 2011 · Interim Report · Regulatory
STRONG SALES INCREASE FOR ABSTRAL® References made in this interim report relate to the Group unless otherwise stated. Figures in parentheses relate to the corresponding period in 2010.

For the period

  • Royalty revenues from Abstral® sales in Europe rose to MSEK 30.4 (19.5).
  • Introduction of Abstral in the US and Canada.
  • Subsequent study of OX219 initiated, with the results expected during the third quarter of 2011.
  • Positive data from the first clinical study for OX27 for the treatment of breakthrough pain in cancer patients.
  • Successful completion of a new share issue of approximately MSEK 245 (before transaction costs).
  • Net revenues totaled MSEK 96.7 (65.5).
  • Loss after tax was MSEK 65.1 (loss: 62.9).
  • Cash flow from operating activities amounted to MSEK -31.2 (11.2).
  • Loss per share was SEK 2.66 (2.69).
  • Cash and cash equivalents totaled MSEK 242.5 at the end of the period (excluding final proceeds from the new share issue that amounted to MSEK 102, received after the period) compared with MSEK 135.8 at year-end.

After the close of the period

  • The insomnia tablet Sublinox (Edluar) licensed to Meda, received marketing approval in Canada.
  • Via its subsidiary Kibion AB, Orexo acquired Wagner Analysen Technik GmbH in Germany.

Second quarter

  • Net revenues totaled MSEK 55.2 (29.1).
  • Cash flow from operating activities was MSEK -47.5 (27.7)
  • Loss after tax was MSEK 26.0 (35.3).
  • Loss per share was MSEK 1.02 (1.51).
     

Key figures

MSEK 3 months
2011
Apr-June		 3 months
2010
Apr-June		 6 months
2011
Jan-June		 6 months
2010
Jan-June 		12 months
2010
Jan-Dec
Net revenues 55.2 29.1 96.7 65.5 210.5
Operating loss -23.6 -32.0 -60.2 -58.7 -81.7
Net loss for the period -26.0 -35.3 -65.1 -62.9 -89.2
Earnings/loss per share, SEK -1.02 -1.51 -2.66 -2.69 -3.81
Cash flow from operating activities -47.5 27.7 -31.2 11.2 -43.0
Cash and cash equivalents 242.5 190.9 242.5 190.9  135.8

Audiocast
CEO Anders Lundström will present the report at an audiocast today at 10:00 am CET. The audiocast with presentation slides can be followed through www.orexo.com and http://www.financialhearings.nu/110810/orexo/ and by telephone +46 (0)8 5352 6439 or +44 (0)20 7136 2051 (confirmation code: 3060498).

 
CEO’s comments

“Sales of Abstral® in Europe continued to rise sharply during the second quarter of the year. The product showed a 66 percent sales increase in the first six months of 2011 compared to the corresponding period in 2010, mainly based on a continued increase in market share in most European markets.

The second quarter marked the introduction of Abstral in two key markets, the US (April) and Canada (June). In the US, the implementation of Abstral’s Risk Evaluation and Mitigation Strategy (REMS) is currently proceeding. We do not expect a fully effective in-market launch of Abstral until the REMS situation is leveled across all rapid onset fentanyl products. Consequently it is today difficult to forecast near term sales trends for Abstral in the US. We anticipate a common REMS program to be in place during the Q1 of 2012. With the program in place, Abstral will be able to compete on equal terms, as it has so successfully done in Europe.

In late June, our new share issue with gross proceeds of approximately MSEK 245 was completed and fully subscribed. The new share issue offers us the potential to continue the development of all three key programs without having to wait for milestone payments from business partners. Our three proprietary programs continued to progress according to plan. The next study for the OX219 program commenced in June, with the results expected during the third quarter of 2011.

The proprietary programs are pivotal for the development of Orexo into a specialty pharmacy company based on its own products. This will enable us to retain a larger share of the products’ value generation in the company.

In connection with the new share issue we noted considerable interest, shown most clearly by the fact that we received cost-free underwriting covering almost 90 percent of the share issue. Novo A/S increased its shareholding to 24.1 percent from its previous 16.6 percent. We also gained two strong institutional shareholders in Abingworth and Arbejdsmarkedets Tillaegspension, ATP.

We are eagerly looking forward to the second half of 2011 when we expect to see additional sales success for Abstral and the results from the next clinical study for OX27 and OX219. Moreover, we will also complete the planning for the initial patient study for OX51.”

Anders Lundström
President and CEO

For further information, please contact:
Anders Lundström, President and CEO, Tel: +46 (0)706 67 22 66, e-mail: anders.lundstrom@orexo.com