Interim report, January-March 2013

Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2012.

The transition to a commercial and profitable pharmaceutical company continues

During the period

  • Net revenues amounted to MSEK 139.8 (83.6).
  • Revenues from launched products increased by 281 percent to MSEK 136.4 (35.8).
  • Earnings after tax were MSEK 27.5 (-16.2).
  • Earnings per share were SEK 0.95 (-0.54).
  • Cash flow from operating activities amounted to MSEK -5.0 (-32.9).
  • Cash and cash equivalents amounted to MSEK 218.9 (212.4).
  • Nikolaj Sørensen was appointed new CEO and Martin Nicklasson Executive Chairman.
  • Orexo sold Abstral® in the USA to Galena Biopharma, Inc. for USD 15 million and royalties.
  • A research agreement was entered into with AstraZeneca regarding OX-CLI, for the treatment of respiratory tract diseases.
  • Collaboration with Novartis AG regarding OX17, for the treatment of GERD, was terminated.
  • Preparations for the launch of Zubsolv continue as planned.

After the end of the period

  • All members of the Board were re-elected at the Annual General Meeting on April 11.
MSEK 2013 2012 2012
Jan-Mar Jan-Mar Jan-Dec
Net revenues 139.8 83.6 326.3
Revenues from launched products 136.4 35.8 267.1
EBIT 30.2 -14.1 -79.4
EBIDTA 31.5 -12.1 -62.1
Earnings after tax 27.5 -16.2 -85.9
Earnings per share 0.95 -0.54 -2.92
Cash flow from operating activities -5.0 -32.9 28.7
Cash and cash equivalents 218.9 212.4 228.1
Equity/assets ratio % 47 61 40

Teleconference
CEO Nikolaj Sørensen and CFO Carl-Johan Blomberg will present the report at a teleconference today at 10:30 a.m. CET. Presentation slides are available via the link and on the website.     Internet: http://financialhearings.nu/130426/orexo/
Telephone: SE: +46-850556483, UK: +44-2076602077, US: +1-8776792993

CEO’s comments

2013 has started at a fast pace. After the agreement with ProStrakan in 2012, we have evaluated the commercial alternatives for Abstral® on the US market. In March, we were pleased to present the result – the sale of the Abstral rights in the USA to Galena Biopharma, Inc., a committed partner that is well-positioned to achieve similar sales growth for Abstral in the USA as in Europe.

The sale of Abstral means that we initially received USD 10 million and will receive a further USD 5 million within twelve months. In addition, there will be future royalties and milestone payments. The agreement with ProStrakan from June 2012 has been central for the financing of the development and commercialization of Zubsolv™ and will give us net payments of over MSEK 700. At the same time, we are very satisfied that the success of Abstral in Europe has continued with unabated strength. Sales increased by 26 percent compared with the corresponding period in 2012.

Our most important strategic and operational objective for the year is a successful launch Zubsolv™ in the USA. We expect that the FDA’s decision regarding approval will be notified at the beginning of July and, as previously announced, we are planning for a launch in September. In order to prepare the launch, we initiated manufacturing at our contract manufacturer’s facility in the USA during the first quarter. In addition we are entering into the necessary agreements for sales and distribution in order to secure that deliveries can start as soon as the product is approved. We are preparing the launch in the USA and are discussing different partnership solutions. The feedback from customers in the US market is very positive to Zubsolv and in September, irrespective of the structure, we will be ready for the most important launch in the history of Orexo.

Two generic Suboxone tablets have been launched on the American market during the first quarter. This was expected and does not change our launch plans or the anticipated market share. We still believe that our formulation has such great advantages for the patients that our vision of Zubsolv becoming a leading product and of reaching a turnover of MUSD 500 is unchanged. The competition from the two generic products is so far negligible, with list prices currently twenty percent higher than the price of the branded Suboxone Film. The Suboxone Film today accounts for 85% of the total market and will be main competitor of Zubsolv.

During the first quarter we have continued our work of developing further taste alternatives and further strengths for Zubsolv in order to strengthen the product’s long-term competitive advantage and to create a broad selection of product variants that will suit all patients.

With this quarter showing a positive EBIT, we have taken an important step forward towards reaching a sustainable profitability at the end of the year.

I eagerly look forward to the near-term strategic events when Orexo begins its new commercial phase, something that we are well equipped for, both in terms of competence and financially.

Nikolaj Sørensen

President and CEO

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 main market today is the US market for the treatment of opioid dependence where the product Zubsolv® is commercialized by Orexo. Other products are commercialized by license partners, including Zubsolv in markets outside of the US. Total net sales for 2016 amounted to SEK 705.9 million and the number of employees was 102. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) index and is available as ADRs on OTCQX (ORXOY) in the US. The head office, where also research and development is performed, is located in Uppsala, Sweden.

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