Interim report January-June 2015

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

Continued growth of Zubsolv® in high-value commercial segment – driven by expanded field force and improved market access position

Second quarter 2015

  • Total net revenues amounted to MSEK 126.5 (117.3).
  • Earnings after tax were MSEK -84.6 (-50.2).
  • Earnings per share were SEK -2.46 (-1.58).
  • Cash flow from operating activities amounted to MSEK -35.6 (-228.2).
  • Orexo divested the subsidiary Kibion; short term negative net impact of MSEK -5.3 on EBIT.
  • FDA approves the medium tablet strength, 2.9 mg/0.71 mg, of Zubsolv.
  • Orexo settles patent infringement litigation against Mylan regarding Edluar®.

First half 2015

  • Total net revenues amounted to MSEK 275.5 (219.1).
  • Earnings after tax were MSEK -100.1 (-71.4).
  • Earnings per share were SEK -2.91 (-2.24).
  • Cash flow from operating activities amounted to MSEK -29.0 (-328.0).
  • Cash and cash equivalents amounted to MSEK 282.1 (110.6).
  • 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 establish Zubsolv as effective, well tolerated for maintenance treatment of opioid dependence and increases patients’ work productivity.
     
MSEK 2015 2014 2015 2014 2014
  Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
Net revenues 126.5 117.3 275.5 219.1 570.3
EBIT -77.3 -38.4 -85.4 -54.7 -25.0
EBITDA -74.2 -35.9 -79.3 -49.8 -12.5
Earnings after tax -84.6 -50.2 -100.1 -71.4 -56.6
Earnings per share, SEK -2.46 -1.58 -2.91 -2.24 -1,73
Cash flow from operating activities -35.6 -228.2 -29.0 -328.0 -487.3
Cash and cash equivalents 282.1 110.6 282.1 110.6 284.5

 
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/150710/orexo/
Telephone: +46 8 566 427 01 (SE), +44 20 342 814 00 (UK) or +1 855 831 5945 (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

A core element of our commercial strategy in the US has been to leverage selected market access agreements to gain prescriber confidence in Zubsolv® and steadily realize an increase in number of prescribers and patients taking advantage of this treatment. The evidence that this strategy is working is exemplified by more than 1 100 new prescribers of Zubsolv in 2015, an increased market share in the commercial segment H1 with 1.3 percentage point to 8.6% and a 20 percent growth in prescriptions from December to June[1] in this segment. However, the rate at which Zubsolv is adopted by new prescribers into their clinical practice is not yet at a level we are satisfied with. We therefore continue to advance our negotiations with payers in the US and are confident that additional contracts in the public segment covering key geographies for Zubsolv will be secured. These contracts will enable Zubsolv to secure a preferential position and possibly an exclusive position in the category in selected geographies during the second half of 2015 and first half of 2016, and thereby facilitate use of Zubsolv for commercially insured patients at the same time.

Overall the market for Zubsolv has shown limited dynamics during the second quarter. Total market shares between the competing products have only moved marginally, although shifts have been realized across the different payer categories. Thus, while Zubsolv has gained around half a percent share in the commercial segment, the overall market share has remained on the same level around 6 percent1 due to loss of share in the cash and public segment. The feedback we receive from physicians starting to prescribe Zubsolv is encouraging, with especially patients new to treatment appreciating the clinical effect and convenience of Zubsolv. However there is inertia from some existing patients and physicians to accept and switch to a new product with higher bioavailability and different dosages than their current treatment. To address the inertia of physicians not prescribing Zubsolv we have increased the size of our field force enabling increased frequency in our dialog with the physicians and reach to more physicians. In an effort to further catalyze the sales of Zubsolv, we have made changes in the commercial leadership structure during the second quarter and initiated a strategy to convert selected top performing representatives of the field force into Orexo employees. We believe these changes will improve performance this year based on enhanced agility, business focus and ability to retain the most talented commercial colleagues in the US.

While our main focus is on the commercialization of Zubsolv in the US, the dialog with potential partners for Zubsolv outside the US and our new product OX51 has progressed well. We will initiate negotiations with several potential partners for both products during the summer.

The second quarter has not met our ambitions of continuous growth in the overall market share of Zubsolv. However, with new agreements improving our market access positions with payers, an extended field force and the launch of two new dosages and anticipated approval of the induction label combined with our dedication to make Zubsolv available to more patients as the drug of choice; my colleagues and I are confident we will see good progress in the second half of 2015 and we will continue to invest to win market share and growing Zubsolv.

Nikolaj Sørensen
President and CEO


[1] IMS weekly prescription data. WK data for same period shows 6.0% market share, the last 4 weeks of June.

 
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 10, 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.