Interim report January-September 2013

Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2012.

Zubsolv® - successfully launched in the US on September 16

During the period

  • Net revenues amounted to MSEK 329.9 (242.7).
  • Revenues from launched products increased by 69 percent to MSEK 321.8 (190.1).
  • Earnings after tax were MSEK -117.1 (-63.6). Earnings include impairment of MSEK 43.9 for OX‑NLA during the second quarter. The project has been licensed to Meda since 2008.
  • Earnings per share were SEK -3.97 (-2.14).
  • Cash flow from operating activities amounted to MSEK -150.3 (105.5).
  • Cash and cash equivalents amounted to MSEK 91.9 (306.2).
  • Zubsolv was approved by the FDA and launched in the US on September 16.
  • Three studies were initiated for Zubsolv regarding early and long-term effects and how well patients comply with treatment.
  • Convertible bonds subscribed for by Novo A/S converted.
  • OX51 phase II study for the prevention of pain in connection with surgical procedures completed.
  • Sponsored Level 1 ADR program initiated in the US (symbol ORXOY on the OTC market).
  • Abstral® approved in Japan.
  • Henrik Juuel appointed new CFO.

Guidance
The previously communicated guidance for Q4 2013 remains unchanged. A positive EBIT for Q4 2013 is still expected.

MSEK 2013 2012 2013 2012 2012
  Jul-Sep Jul-Sep Jan-Sep Jan-Sep Jan-Dec
Net revenues 121.1 76.1 329.9 242.7 326.3
Revenues from launched products 116.8 73.9 321.8 190.1 267.1
EBIT -25.5 -29.2 -107.9 -57.7 -79.4
EBIDTA -24.0 -27.7 -60.0 -52.5 -62.1
Earnings after tax -28.9 -30.8 -117.1 -63.6 -85.9
Earnings per share -0.94 -1.05 -3.97 -2.14 -2.92
Cash flow from operating activities -229.9 -66.9 -150.3 105.5 28.7
Cash and cash equivalents 91.9 306.2 91.9 306.2 228.1

Teleconference
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference today at 2 p.m. CET. Presentation slides are available via the link and on the website.
Internet: http://financialhearings.nu/131023/orexo/
Telephone: SE: +46851999359, UK: +442076602077, US: +18557161598

For further information, please contact:
Nikolaj Sørensen, CEO, tel: +46 (0)703 50 78 88, e-mail: [email protected]
Henrik Juuel, EVP and CFO, tel: +46 (0)722 20 94 77, e-mail: [email protected]

CEO’s comments

In the half-year report, we communicated that we received the formal FDA approval for Zubsolv® in the US just a few days into the third quarter. Once approval had been secured, intense launch preparations were further accelerated, including setting up a U.S. subsidiary and creating awareness of Zubsolv with key customers. Comprehensive and extensive preparations and the recruiting of a highly competent and experienced team in the US enabled Zubsolv to be launched in September with reimbursement for more than 70% of current patients in the market. Moreover, approximately 11,000 pharmacies pre-ordered Zubsolv, for stocking purposes, ensuring a readiness to meet the demand for Zubsolv. It is a significant accomplishment for Orexo to have been able to set up an entire commercial organization and secure the supply of Zubsolv across the US in the course of just a few months. I am proud of my many colleagues who have worked intensely all summer to make this happen.

The foundation for the launch of Zubsolv has now been laid and we begin the exciting work of gaining market share and improving treatment of opioid dependence. The feedback from patients and prescribing physicians, that I have received, has been positive, even if many prescribing physicians first want to test the product on a few patients before they begin to use Zubsolv more widely. Many important prescribing physicians have already come back to us with promising feedback and I anticipate seeing rapidly increasing sales during the fourth quarter and accelerating during 2014.

A key factor for the continuing success of Zubsolv is to secure competitive reimbursement conditions. I see good progress in the on-going negotiations indicating significant improvement in reimbursement during Q1 2014 for both commercial and public plans. I am awaiting final outcome of pricing reviews scheduled by most payers during Q4 2014 and I expect to see the first significant improvements in reimbursement late this year. I see no signals of Zubsolv being without reimbursement for the major commercial and public plans and I expect restrictions in prescriptions to be limited to a few, primarily public plans. I am certain that many patients will shortly have access to Zubsolv with similar reimbursement to our competition.

The launch of Zubsolv two weeks before the end of the quarter naturally entails only a small effect on sales for the quarter, but I am following the development of sales in the US closely. The focus of the US team is to get the high-prescribing physicians to start prescribing Zubsolv, in anticipation of 2014 and for future growth of the product.

The first nine months of 2013 have been rewarding for the Orexo team as our hard work has begun to bear fruit. Our journey as a fully integrated specialty pharmaceutical company is now in full bloom, and I look forward to leading Orexo as a top tier organization improving treatment for millions of people suffering from opioid dependence.

Nikolaj Sørensen
President and CEO
   

Please note
Orexo AB publ discloses the information provided herein pursuant to the Financial Instruments Trading Act and/or the Securities Market Act. The information was provided for public release on October 23, 2013, 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.