Full Year Report 2016

2016 - First profitable year

Fourth quarter 2016

  • Total net revenues MSEK 184.7 (228.3)  
  • Zubsolv® net revenue MSEK 128.2 (120.3)
  • Net earnings MSEK 33.3 (-51.8) 
  • Earnings per share, before and after dilution, SEK 0.97/0.96 (-1.50)
  • Cash and cash equivalents MSEK 282.4 (198.1) 
  • Together with Mundipharma Orexo made the first EU regulatory submission of a Marketing Authorisation Application (MAA) for Zubsolv for the treatment of opioid dependence
  • FDA approved a new unique low 0.7mg/0.18mg dosage of Zubsolv
  • The US District Court for the District of Delaware ruled in Orexo’s favor in one of the patent infringement litigations against Actavis regarding Orexo´s ´996 patent protecting Zubsolv in the US. Patent ´330 declared invalid.
  • The decision rendered by the US District Court for the District of Delaware regarding the validity of Orexo’s ´330 patent protecting Zubsolv in the US has been appealed
  • Completion of a bond buyback program amounting to a nominal value of MSEK 99

January - December 2016

  • Total net revenues MSEK 705.9 (646.2)  
  • Zubsolv net revenue MSEK 481.8 (416.7)
  • Net earnings MSEK 29.0 (-210.0) 
  • Earnings per share, before and after dilution, SEK 0.84 (-5.74)
  • Cash flow from operating activities MSEK 156.2 (-109.2)
  • Cash and cash equivalents MSEK 282.4 (198.1) 
  • AstraZeneca acquired all rights to Orexo´s OX-CLI project for MUSD 5 (MSEK 40.8)
  • 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 Rest of the World rights to Zubsolv 
  • The US Department of Health and Human Services (HHS) announced an increase in buprenorphine patient cap from 100 to 275 
  • The US Congress signed CARA into law which grants the expansion of buprenorphine prescribing privileges to nurse practitioners and physicians assistants 
  • Completion of 1,080 patient REZOLV study and reported on important characteristics intended to improve opioid dependent patient outcomes
MSEK 2016 2015 2016 2015
Oct-Dec Oct-Dec Restated Jan-Dec Jan-Dec Restated
Net revenues 184.7  228.3 705.9  646.2
EBIT 33.2  -44.3 51.7  -180.6
EBITDA 44.2 24.8 74.5 -100.0
Net Earnings 33.3  -51.8 29.0  -210.0
Earnings per share, before   and after dilution, SEK 0.97/0.96  -1.50/
  -1.49
0.84/0.84  -6.07/
  -6.07
Cash flow from   operating activities N/A N/A 156.2 -109.2
Cash and cash   equivalents 282.4  198.1 282.4  198.1

For information regarding
restatement of prior periods see note 1

Teleconference    
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference on January 26, 2017, at 2:00pm CET. Please view instructions below on how to participate.
Internet:
https://wonderland.videosync.fi/orexo-q4-report-2016
Telephone: +46 8 566 426 62 (SE), +44 20 300 898 04 (UK) or +1 855 753 2236 (US). 
There will be a Q&A session and questions can also be sent in advance to [email protected] at latest 11pm CET.   
The presentation will be available at Orexo´s website one hour prior to the teleconference.           

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

CEO’s comments

I am pleased to announce 2016 as the first year in the history of Orexo with full year positive earnings. This marks an important milestone for the company in the quest to become a sustainable specialty pharmaceutical company. The company is now standing on a solid financial foundation with five consecutive quarters of positive cash flow from operating activities and we project 2017 will continue with positive cash flow and EBIT on a full year basis.

The main growth driver has been Zubsolv®, with revenue growth of 15.6 percent compared to 2015. This growth was accomplished despite a loss in market share early in the year due to changes in the market access position. Continued improvement in market access for Zubsolv remains a key success factor moving forward. Even though Zubsolv was negatively impacted by some external market events in late 2016, in particular a large health care provider group decided to leave WellCare in December, we are starting 2017 with a better market access position compared to 2016.

Opioid dependency is a problem that continues to grow and therefore it´s encouraging to see that more than 2,600 physicians have been certified to expand their prescriber base up to 275 patients in their treatment programs in the US. About half of these physicians have already started to recruit more patients and we expect many of the remaining physicians to expand their patient base in 2017. Zubsolv is winning a disproportionate share of this market growth and we expect this to continue in 2017.

Another key event during the quarter was the first decision in our litigation against Actavis. Since Actavis has not appealed the validity of the decision on the ‘996 patent, Zubsolv exclusivity is now secured until at least until September 2019. We have appealed the decision concerning our 330’ patent to the federal circuit and expect their decision to come within 12 months. Thus, with the appeal and two additional patents valid until 2032, which are subject to separate court cases, I maintain confident in the long term IP protection of Zubsolv.

We reached profitability in 2016 and now it is essential for us to continue to improve the productivity of our organization to maintain the profitability in 2017 and beyond. To fully leverage the existing commercial infrastructure we aim to add more products to our commercial organization and this will be a key objective for the year. In addition we expect a substantial improvement with regard to the cost of goods of Zubsolv with gradual impact starting in 2018. In our development team we aim at advancing some of our early R&D projects into a concrete innovative product pipeline. My colleagues and I are looking forward to 2017 as a year with many opportunities to further strengthen Orexo.

Nikolaj Sørensen
CEO and President
 

Forward looking statements:
This report includes forward-looking statements. Actual results may differ from those stated. Internal and external factors may affect Orexo’s results.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00am CET on January 26, 2017.