Interim report January-September 2014

Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2013.

Zubsolv® evolution continues. 81 percent increase in Zubsolv tablets prescribed compared to previous quarter.

Third quarter 2014

  • Total net revenues amounted to MSEK 130.7 (121.1). Revenues from launched products, excluding one-off milestones, amounted to MSEK 130.7 (70.3).
  • Earnings after tax were MSEK -36.8 (-28.9).
  • Earnings per share were SEK -1.13 (-0.94).
  • Cash flow from operating activities amounted to MSEK -152.1 (-229.9).
  • OX-MPI project was returned to Orexo.
  • Orexo enhanced its commercial focus by placing all manufacturing of Zubsolv with partners in the US and streamlining operations in Uppsala.
  • Orexo completed its private placement of approx. MSEK 346.5, including all Orexo shares held in treasury by the company in addition to newly issued shares.

January-September 2014

  • Total net revenues amounted to MSEK 349.8 (329.9). Revenues from launched products, excluding one-off milestones, amounted to MSEK 348.1 (211.0).
  • Earnings after tax were MSEK -108.2 (-117.1).
  • Earnings per share were SEK -3.37 (-3.97).
  • Cash flow from operating activities amounted to MSEK -480.0 (-150.3).
  • Cash and cash equivalents amounted to MSEK 299.2 (91.9).
  • Reimbursement agreement for Zubsolv signed with UnitedHealth Group and OptumRx.
  • Orexo completed issue and listing of a MSEK 500 unsecured bond.
  • inVentiv Health selected as new partner for the commercialization of Zubsolv in the US.
  • Positive results from two phase III clinical trials assessing Zubsolv for induction of buprenorphine maintenance therapy.
  • Top-line data from a phase III clinical trial demonstrated that Zubsolv is as effective as Suboxone® film in the treatment of opioid dependence.
  • Orexo commenced patent infringement litigation against Actavis.

After the period

  • Orexo submitted application to FDA for expanded label for Zubsolv®.
MSEK 2014 2013 2014 2013 2013
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Jan-Dec
Net revenues 130.7 121.1 349.8 329.9 429.4
Revenues from launched products 130.7 116.8 348.1 321.8 421.6
EBIT -29.3 -25.5 -84.0 -107.9 -139.7
EBITDA -26.8 -24.0 -76.6 -60.0 -89.1
Earnings after tax -36.8 -28.9 -108.2 -117.1 -154.9
Earnings per share, SEK -1.13 -0.94 -3.37 -3.97 -5.16
Cash flow from operating activities -152.1 -229.9 -480.0 -150.3 -265.8
Cash and cash equivalents 299.2 91.9 299.2 91.9 105.6

CEO Nikolaj Sørensen, CFO Henrik Juuel and Chief Medical Officer Michael Sumner will present the report at a teleconference today at 1:30pm CET (07:30am EDT)..
Presentation slides are available via the link and on the website.
Telephone: +46 8 519 993 59 (SE), +44 203 194 05 53 (UK) or +1 855 269 26 07 (US).

For further information, please contact:
Nikolaj Sørensen, CEO or Henrik Juuel, EVP and CFO
Tel: +46 (0)18 780 88 00, E-mail:

CEO’s comments
During the third quarter we have taken several important steps to improve the treatment of opioid dependence and to establish Zubsolv as a preferred choice. We finalized the detailed analysis of our clinical studies. Especially the ISTART study demonstrated interesting and positive data for Zubsolv, outlined in the Zubsolv section, which will become the foundation for our commercial efforts in the fourth quarter. Another important milestone has been the implementation of the agreement with United Health Group (UHG) where Zubsolv became the exclusive choice for patients in the highly controlled plans of UHG. The agreement with UHG has been followed by additional market access agreements, the most noteworthy being the agreement with the largest commercial prescription payer, the pharmacy benefit manager (PBM) Express Scripts (ESI) and a leading Managed Medicaid provider WellCare. ESI will place Zubsolv in a preferred position from January 2015 and WellCare will place Zubsolv in an exclusive position with implementation starting in November this year.

I am pleased to see that sales of Zubsolv continue to grow; in terms of tablets prescribed Zubsolv increased by more than 80 percent compared to the second quarter. The significant growth resulted in a market share (tablets prescribed) that increased to 4 percent in September compared to 2.3 percent in June. A lot of the growth came from our agreement with UHG, however we also experienced double digit growth in all other major books of business, and even within large commercial insurance companies where Zubsolv is not yet a preferred product, for instance within ESI, we saw double digit growth. This shows that Zubsolv is competitive and during the summer we have seen many of our sales districts exceeding 10 percent market share in the commercial prescription segment i.e. the market segment where we have comparable or better market access than our competitors.

A continuous clinical and pharmaceutical development of Zubsolv is the foundation for our strategy to ensure sustainable long term growth. A first step on the clinical development was taken when we filed an application to expand the Zubsolv label to include Induction of treatment. In addition, we are expecting approval of our higher strengths shortly. With a new label and new dosages, more patients can get the right dose by taking only one tablet and thus reduce the need to combine different dosages from the first day of treatment. We are working on several additional life cycle initiatives for Zubsolv, which can differentiate the product further from competing treatment alternatives.

To ensure a solid financial foundation of Zubsolv and to advance our pipeline, we successfully completed a private share placement in September. Our major investments in inventory and clinical studies are behind us, we have streamlined the Swedish operations, and our US commercial operations are very close to break-even, we are now well positioned to expand our focus and will initiate the next steps in our development pipeline. Two immediate initiatives will be to decide the final development path and commercialization strategy for OX51 and for Zubsolv outside the US. For both initiatives we will assess the optimal timing of involving external partners from a value creation perspective. This will enable a continued management and R&D focus on the Zubsolv US launch and life cycle management.

Our main focus remains on the commercialization of Zubsolv. We will continue to expand our field force as market access improves and our expectations for the last quarter of 2014 are set high. We have accomplished a lot during the first three quarters of 2014, and we are fully committed to continue at a high pace to ensure that we gain additional market share, fully leveraging the clinical results from the ISTART study and improved market access.

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 22, 2014, at 8:00 am CET. 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.