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2017-01-26

Orexo: 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 Oct-Dec Jan-Dec Jan-Dec Restated
-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 0.97/0. -1.50/ 0.84/0.84 -6.07/
and after dilution, SEK 96 -1.49 -6.07
Cash flow from operating N/A N/A 156.2 -109.2
activities
Cash and cash 282.4 198.1 282.4 198.1
equivalents

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

ir@orexo.com 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: ir@orexo.com

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.

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http://news.cision.com/orexo/r/full-year-report-2016,c2173922
http://mb.cision.com/Main/694/2173922/619277.pdf

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