Orexo: Interim report January-June 2014

Regulatory News:

Orexo (STO:ORX):  

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

Positive results from clinical trials with Zubsolv®

Second quarter 2014

• Total net revenues amounted to MSEK 117.3 (69.0). Revenues from launched products, excluding one-off milestones, amounted to MSEK 115.6 (68.6). Revenue recognition approach for Zubsolv changed from the second quarter.
• Earnings after tax were MSEK -50.2 (-115.7).
• Earnings per share were SEK -1.58 (-4.00).
• Cash flow from operating activities amounted to MSEK -228.2 (84.4).
• 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 3 clinical trials assessing Zubsolv for induction of buprenorphine maintenance therapy.
• Top-line data from a phase 3 clinical trial demonstrated that Zubsolv is as effective as Suboxone® film in the treatment of opioid dependence.
• Orexo commenced patent infringement litigation against Actavis.

First half 2014

• Total net revenues amounted to MSEK 219.1 (208.8). Revenues from launched products, excluding one-off milestones, amounted to MSEK 217.4 (140.7).
• Earnings after tax were MSEK -71.4 (-88.2).
• Earnings per share were SEK -2.24 (-3.05).
• Cash flow from operating activities amounted to MSEK -328.0 (79.4).
• Cash and cash equivalents amounted to MSEK 110.6 (300.7).
• Reimbursement agreement for Zubsolv signed with UnitedHealth Group and OptumRx.

Teleconference

CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference today at 1:00pm CET. Presentation slides are available via the link and on the website. Internet: http://financialhearings.nu/140711/orexo/ Telephone: +46 8 519 993 53 (SE), +44 20 766 020 77 (UK) or +1 877 788 90 23 (US).

CEO’s comments

The second quarter of 2014 has been another eventful quarter for Orexo. In May, we issued a MSEK 500 non-secured corporate bond, fully subscribed a few days after the announcement, showing confidence from investors in our business. Later the same month, we announced a new commercialization partner, and finally in June, we finalized two clinical trials (ISTART and 007) with positive results, further enhancing our ability to differentiate Zubsolv from competitors. In parallel, Zubsolv® sales volume (tablets, demand) has grown by nearly 20% from the first quarter and Zubsolv has started to gain market share again.

The major achievement during the quarter was the finalization and positive outcome of two of our clinical trials with Zubsolv. Short term, the studies will provide convincing scientific evidence of the equivalent efficacy of Zubsolv, despite a 29% lower dose of buprenorphine, compared to the leading competitor in the market. This has been a concern raised by patients and prescribers during the launch phase. Long term, the positive results of the combined ISTART and 007 studies in the induction phase of treatment for opioid dependence, can provide Zubsolv with additional differentiation from generic alternatives. We plan to submit our application for an expansion of the Zubsolv label to include induction during the fourth quarter of 2014. The two clinical trials, are, to our knowledge, the largest ever made in this disease area and underscores the commitment that Orexo has to advance the quality of treatment of patients suffering from opioid dependence, based on science, research and development.

In May, we announced a new partnership with inVentiv Health for our commercial field activities. With the new partnership, we take the full leadership of the commercialization and all sales managers are employed by Orexo. The change will enhance our agility and decisiveness in our commercial efforts in the launch of Zubsolv. I am pleased to announce that all sales representatives selected by Orexo, who were offered a position, have decided to move to the new contract. This is an excellent evidence of the commitment to and belief in the opportunities for Zubsolv, from those who are meeting customers every day in the field.

We look forward to the second half of 2014, which will jump start with the implementation of the exclusive agreement with UnitedHealth Group on July 1, expected to provide an immediate positive impact on Zubsolv revenues. I personally spend a considerable amount of time in the US, meeting prescribers in their offices. The feedback I receive from prescribers who have made Zubsolv their preferred choice, makes me even more convinced of the market potential of Zubsolv and the value it can bring to patients with the advanced sublingual tablet formulation, offering patients a choice of treatment with a fast dissolve time, a pleasant menthol taste and with a 29% lower dose compared to the leading competitors.

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 July 11, 2014, 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.

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