Interim Report January-June 2016

Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2015.

Positive cash flow and EBIT. Expansion of Zubsolv® to new markets and improved market access position in the US.

Second quarter 2016 

• Total net revenues MSEK 188.2 (126.5).  
• Zubsolv net revenue MSEK 178.2 (91.1).
• Earnings after tax MSEK 5.0 (-84.6). 
• Earnings per share SEK 0.14 (-2.46).
• Cash flow from operating activities MSEK 20.0 (-35.6).
• Cash and cash equivalents MSEK 252.9 (282.1). 
• Zubsolv was selected by the State of Maryland as the exclusive preferred buprenorphine/naloxone agent for the FFS Medicaid Formulary effective July 1, 2016.
• A license agreement was signed with Mundipharma, which obtains ex-US global rights to Zubsolv. The upfront payment of MEUR 7 (MSEK 65.4) is fully included as revenue in the quarter. The agreement also includes potential future royalties and milestone payments.

First half year 2016

• Total net revenues MSEK 339.2 (275.5).  
• Zubsolv net revenue MSEK 276.6 (185.6).
• Earnings after tax MSEK -29.5 (-100.1). 
• Earnings per share SEK -0.85 (-2.91).
• Cash flow from operating activities MSEK 42.5 (-29.0).
• AstraZeneca acquired all rights to Orexo´s OX-CLI project for MUSD 5 (MSEK 40.8). The agreement also includes potential future royalties and milestone payments.

Important event after the period

• The United States Department of Health and Human Services (HHS) announced an increase in the buprenorphine patient cap from 100 to 275.

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

During the quarter Orexo attained several important objectives and continues to build additional financial strength with a positive EBIT and for the second consecutive quarter a positive cash flow.

I am encouraged by and enthusiastic about the opportunities for Orexo arising from the announcement the increase in the number of patients each physician can treat for opioid dependence in the US from 100 to 275. I am confident this market expansion will benefit Zubsolv® and Orexo.  

In light of the expected growth in patient access treatment, I am pleased to announce that effective July 1st Zubsolv is the only preferred buprenorphine/naloxone product within the largest Fee For Service (FFS) Medicaid program in the US, the state of Maryland. The Maryland decision strengthens Orexo´s and Zubsolv’s position in the increasingly important public segment.  

Prior to the implementation of the Maryland agreement and anticipated market growth following the cap lift, I was pleased to see our net sales of Zubsolv in the US grow during the quarter by nearly 15 percent compared to Q1, driven by a mix of increased demand, inventory and improved gross to net ratio.

Opioid dependence is a growing global epidemic and today 20 million people outside the US are estimated to suffer from the disease. I am looking forward to a successful partnership with Mundipharma to make Zubsolv available to patients across the world. For Orexo the priority has been to find a partner with an international organization covering all of the key markets for Zubsolv and with a strong track record of successful launch and commercialization of many products on a global scale. Besides creating value from the launch of Zubsolv outside the US, we are also expecting other scale effects which will positively contribute to the creation of value and support our progress towards sustainable profitability.

I am proud to see that we achieved a positive EBIT and cash flow in this quarter due to the closure of the Mundipharma agreement and a continued overall improved financial performance. In this quarter our expenses for the on-going patent litigation against Actavis in the US have increased, due to the completion of the trial in the district court of Delaware. We remain confident that the court will support our claims and the validity of our patents for Zubsolv, enabling us to fully capitalize on the opportunities materializing this quarter and early July.

Nikolaj Sørensen
CEO and President