Interim report January-September 2015

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

Zubsolv® growth driven by patient and physician choice

Third quarter 2015

  • Total net revenues amounted to MSEK 139.5 (130.7).
  • Zubsolv net revenue amounted to MSEK 110.8 (68.4).
  • Earnings after tax were MSEK -46.1 (-36.8).
  • Earnings per share were SEK -1.33 (-1.13).
  • Cash flow from operating activities amounted to MSEK -79.5 (-152.1).
  • Zubsolv excluded from CVS Caremark preferred position in 2016 after closed tender process.
  • New exclusive agreement with unnamed Pharmacy Benefit Manager in Managed Medicaid.
  • FDA approved Zubsolv for induction treatment of opioid dependence.
  • U.S. Department of Health and Human Services announced intention to expand patient access to treatment of opioid dependence.

January - September 2015

  • Total net revenues amounted to MSEK 415.0 (349.8).
  • Zubsolv net revenue amounted to MSEK 296.4 (148.5).
  • Earnings after tax were MSEK -146.2 (-108.2).
  • Earnings per share were SEK -4.24 (-3.37).
  • Cash flow from operating activities amounted to MSEK -108.5 (-480.0).
  • Cash and cash equivalents amounted to MSEK 201.2 (299.2).
  • Orexo broadened Zubsolv product range by launching Zubsolv 8.6 mg/2.1 mg.
  • Orexo announced newly listed granted US patent.
  • Orexo commenced patent infringement litigation against Actavis concerning Abstral® in the US.
  • New clinical data established Zubsolv as effective, well tolerated for maintenance treatment of opioid dependence and increases patients’ work productivity.
  • Orexo divested the subsidiary Kibion; short term negative net impact of MSEK -5.3 on EBIT.
  • FDA approved the medium tablet strength, 2.9 mg/0.71 mg, of Zubsolv.
  • Orexo settled patent infringement litigation against Mylan regarding Edluar®.

After the period: Nothing to report.

MSEK 2015 2014 2015 2014 2014
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Jan-Dec
Net revenues 139.5 130.7 415.0 349.8 570.3
EBIT -39.4 -29.3 -124.7 -84.0 -25.0
EBITDA -33.9 -26.8 -113.1 -76.6 -12.5
Earnings after tax -46.1 -36.8 -146.2 -108.2 -56.6
Earnings per share, SEK -1.33 -1.13 -4.24 -3.37 -1,73
Cash flow from operating activities -79.5 -152.1 -108.5 -480.0 -487.3
Cash and cash equivalents 201.2 299.2 201.2 299.2 284.5

Teleconference:
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference today at 2:00pm CET.
Presentation slides are available via the link and on the website.
Internet:
http://financialhearings.nu/151022/orexo/
Telephone: + 46 856642693 (SE), + 44 2034281434 (UK) or +1 6465025118 (US).

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

CEO’s comments
The third quarter has been eventful for Orexo. Overall the quarter has developed in a positive direction, even if the decision by the Pharmacy Benefit Manager (PBM) CVS Caremark in August to remove Zubsolv® from the preferred formulary was a short term setback. For the medium and long term, the most important and encouraging news for Zubsolv’s growth potential was the announcement of plans by the US Government to expand access to treatment of opioid dependence in the US and the FDA approval of Zubsolv for use at initiation of treatment for opioid dependence (Induction) on August 11th.

We are encouraged by Zubsolv’s positive growth in demand and market share during the third quarter. The demand for Zubsolv grew by 6 percent[1] and the market share increased by 0.3 percentage points to 6.2 percent. The main growth drivers were the profitable non-exclusive commercial and cash segments. These segments are associated with lower rebates, and in combination with growth and stable inventory levels at the wholesalers, net sales of Zubsolv grew by 22 percent compared to Q2.

Since the launch of Zubsolv, we have repeatedly highlighted the significant patient need for increased access to treatment. We therefore welcome the initiative from the United States Department of Health and Human Services’ (HHS) Secretary Sylvia M. Burwell, to improve patient access to medication assisted treatment. The actual changes to the legislation are yet to be disclosed. We anticipate this increase in access to be ruled upon later this year or early next year. The ambition level indicates that the changes will have substantial positive impact on the access to treatment in the long term. To cite Secretary Burwell: “Despite the evidence supporting the clinical efficacy of MAT (Medical Assisted Treatment) for the treatment of opioid use disorders, it is highly underutilized”. An expansion to MAT is anticipated to have positive effect on patient wellbeing, market dynamics and growth opportunities for Zubsolv long term.

During the third quarter, we signed two framework agreements with PBMs, enabling an improved position in large public plans. These two agreements can potentially more than compensate for the market share loss from CVS Caremark during 2016. We announced one of these in August and the other one was signed later in the quarter. We continue to have a constructive dialog with several major payer organizations and expect further improvements in market access in the fourth quarter.  

I am personally satisfied that we during the third quarter continued to improve our commercial position through the new approval of the induction label, increasing sales and market share, new market access agreements further supported by the future significant improvement in the market conditions with the anticipated changes in the legislation in the US. Our efforts to find a partner for Zubsolv outside the US and our exciting project OX-51 continue to progress well. We are confident that we will find partners for these two products further strengthening Orexo’s long term growth opportunities.  

Nikolaj Sørensen
President and CEO


[1] All sales data is IMS weekly prescription data using four week rolling averages for market share and growth.

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, 2015, at 8:00am 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.

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About Us

Orexo develops improved pharmaceuticals based on innovative drug delivery technologies. The focus is primarily on opioid dependence and pain but the aim is to address therapeutic areas where our competence and technologies can create value. The products are commercialized by Orexo in the US or via selected partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo sells the product Zubsolv®. Total net sales for 2017 amounted to SEK 643.7 million and the number of employees at year-end was 90. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The head office, where research and development is also performed, is situated in Uppsala, Sweden.

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