Interim report January-March 2015

Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2014.

First quarter shows continued sales growth and positive cash flow. Broadening of Zubsolv® dosage range proceeds.

First quarter 2015

  • Total net revenues amounted to MSEK 149.0 (101.9).
  • Earnings after tax were MSEK -15.5 (-21.1).
  • Earnings per share were SEK -0.45 (-0.66).
  • Cash flow from operating activities was positive and amounted to MSEK 6.5 (-99.7).
  • Cash and cash equivalents amounted to MSEK 289.3 (30.7).
  • Orexo broadened Zubsolv product range by launching Zubsolv 8.6 mg.
  • FDA accepted submission of 2.9 mg Zubsolv dosage.
  • Orexo announced newly listed granted US patent.
  • Orexo commenced patent infringement litigation against Actavis concerning Abstral in the US.

After the period

  • David Colpman was elected as a new board member at the AGM on April 15, 2015.
  • New clinical data establish Zubsolv as effective, well tolerated for maintenance treatment of opioid dependence and increases patients’ work productivity.

    MSEK 2015 2014 2014
    Jan-Mar Jan-Mar Jan-Dec
    Net revenues 149.0 101.9 570.3
    Revenues from launched products 149.0 101.9 568.6
    EBIT -8.1 -16.2 -25.0
    EBITDA -5.1 -13.7 -12.5
    Earnings after tax -15.5 -21.1 -56.6
    Earnings per share, SEK -0.45 -0.66 -1.73
    Cash flow from operating activities 6.5 -99.7 -487.3
    Cash and cash equivalents 289.3 30.7 284.5

    Teleconference
    CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference on April 23, 2015 at 2:00 pm CET (08:00 am EDT). Presentation slides are available via the link and on the website.
    Internet: http://financialhearings.nu/150423/orexo/
    Telephone: +46 8 566 426 65 (SE), +44 20 342 814 02 (UK), +1 855 753 22 35 (US)

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

      
    CEO’s comments

    In the first quarter we experienced continuing growth in demand of Zubsolv® and a 0.4 percentage point improvement in market share from 5.73 percent to 6.13 percent , based on the four-week rolling market share in daily dosages. Looking deeper into market dynamics we have seen some significant changes in market share. In particular with WellCare, where start-of-the-year movements between insurance programs have led to a declining in overall market share of 0.3 percentage point. This loss of market share has been more than compensated by increased market share at United Health Group, an exclusive contract with Independent Health Associates (Buffalo, NY) and a gain in market share with the two largest PBM”s, ESI and CVS Caremark.

    We have reached positive cash flow during the first quarter, further strengthening our financial position. However our future cash flow generation is highly dependent on our decision to invest in further development and commercialization of Zubsolv. We will initiate a new clinical study and continue the controlled expansion of the field force during 2015 to drive additional sales and market share capture in the US.  

    In March, we launched our first new higher strength Zubsolv tablet (8.6 mg/2.1 mg buprenorphine/naloxone). This is the first of several new dosages of Zubsolv that we plan to launch this year. Also during the first quarter the FDA accepted our submission of a 2.9 mg/0.8 mg buprenorphine/naloxone dosage. We anticipate approval of this new dosage during the third quarter and a coordinated launch in combination with the previously approved 11.4 mg/2.9 mg buprenorphine/naloxone dosage. We also completed our clinical cohort study OX219-008, which together with the previous ISTART study confirms that the safety, tolerability and efficacy are comparable to our largest competitor and that there is a strong patient preference for Zubsolv.

    A key focus for Orexo is to continue broadening the prescriber base. We have seen market share among our 4,800 consistent prescribers increase to more than 11 percent at the end of the quarter. In all of the exclusive contracts we have won, we have seen the prescribers involved starting to prescribe to other patients, for example in the WellCare districts the prescription of Zubsolv to patients without WellCare insurance doubled following the exclusive contract with WellCare starting November 1, 2014. Currently, to further broaden the Zubsolv prescriber base, we are selectively increasing our field force where we gain reimbursement from additional payers, enabling a broader reach to more prescribers. We continue to pursue improvements in market access and expect to see additional agreements during the second half of 2015.

    The work of finding partner for Zubsolv outside the US and a partner for the final development and commercialization of OX51 has been initiated. We have received expressions of interest in both of these products, from both regional and global pharmaceutical companies. We anticipate that we will have selected a partner late this year for at least one of these products.

    My colleagues at Orexo and I remain dedicated to ensuring that Zubsolv continues to gain market share and becomes available to more patients as the drug of choice, thus helping them in their fight against opioid addiction.

    Nikolaj Sørensen
    President and CEO

    [1] Wolter Kluwer/www.redeye.se

      
    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 April 23, 2015, 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.