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2016-10-20

Orexo: Interim Report January-September 2016

Strong Zubsolv® and Abstral® revenue growth.

Third quarter 2016

· Total net revenues MSEK 181.9 (139.5).
· Zubsolv net revenue MSEK 142.8 (110.8).
· Net earnings MSEK 36.0 (-46.1).
· Earnings per share, before and after dilution, SEK 1.04 (-1.33).
· Cash flow from operating activities MSEK 31.2 (-79.5).
· Cash and cash equivalents MSEK 276.9 (201.2).
· The US Department of Health and Human Services (HHS) announced
an increase in buprenorphine patient cap from 100 to 275.

· The Congress signed CARA1into law which among others will expand
the prescription rights to nurse practitioners and physicians
assistants.

· Completion of 1,080 patient REZOLV study and reported on
improved treatment of opioid dependent patients.

January - September 2016

· Total net revenues MSEK 521.2 (415.0).
· Zubsolv net revenue MSEK 419.5 (296.4).
· Net earnings MSEK 6.5 (-146.2).
· Earnings per share, before and after dilution, SEK 0.19 (-4.24).
· Cash flow from operating activities MSEK 73.7 (-108.5).
· Cash and cash equivalents MSEK 276.9 (201.2).
· 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.

Important events after the period

· Orexo together with Mundipharma made 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.
MSEK 2016 2015 2016 2015 2015
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Jan-Dec
Net revenues 181.9 139.5 521.2 415.0 643.3
EBIT 43.0 -39.4 29.1 -124.7 -169.0
EBITDA 50.9 -33.9 48.8 -113.1 -88.3
Net Earnings 36.0 -46.1 6.5 -146.2 -198.0
Earnings per share, before 1.04 -1.33 0.19 -4.24 -5.74
and after dilution, SEK
Cash flow from operating 31.2 -79.5 73.7 -108.5 -102.2
activities
Cash and cash equivalents 276.9 201.2 276.9 201.2 198.1

Teleconference
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report
at a

teleconference on October 20, 2016, at 2:00pm CET.
Presentation slides are available via the link and on the website.
Internet:
https://wonderland.videosync.fi/2016-10-20-orexo-q3-report

Telephone: +46 8 566 426 62 (SE), +44 20 300 898 04 (UK) or +1 855
753

2236 (US).
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 with the positive EBIT and cash flow result of the third
quarter. The result is primarily driven by positive Zubsolv® and
Abstral® revenue growth with 30 percent versus Q3 2015. However, this
quarter we also benefited from inventory built up in Maryland, lower
expenses than expected and favorable currency development. In
addition to the positive financial results the quarter has been
highlighted by two significant events, the patient cap lift in the US
and the progression towards launching Zubsolv in Europe as well.

In July the US Government ruled to take action and expand access to
treatment of opioid dependence. I am encouraged to see over 1,500
physicians have received the certification to expand to 275 patients
as of mid-October. Our ambition is to win a disproportionate share of
the new patients in the regions where Zubsolv is reimbursed and have
market access comparable to our main branded competitors. Though
early in the process I am pleased to find this is beginning to occur
especially with physicians covered by our field force today. With
regards to market access we have maintained or improved our position
with all major insurance plans and we have strengthened our position
in all payer segments, both winning new contracts and renewing
existing ones. Although encouraged by the improving market access
especially in the public segment, an increased importance of the
public segment will increase the average rebate level for Zubsolv US.

In Europe we took a first important step to be able to launch Zubsolv.
We have worked intensively in collaboration with Mundipharma
throughout the quarter to finalize the bio-equivalence study required
to complete the European filing and prepare the dossier. Earlier than
expected, on October 3rd, we submitted the file and expect approval
in Q4 2017.

Apart from the progression of our commercialization of Zubsolv, the
court case against Actavis has required a lot of our attention during
the quarter and 2016. We maintain a high degree of confidence in the
strengths of our patents i.e. they are valid and Actavis is
infringing. In parallel with the court case our patent portfolio
around Zubsolv has continued to expand and this has led to additional
litigation processes against Actavis. The first decision from the
court is expected in the fourth quarter of 2016.1)

In August we finalized the REZOLV study and in early October, we
announced the approval of a new low dosage of Zubsolv. These
announcements mark the completion of the pharmaceutical and clinical
development program for Zubsolv. With the finalization of the Zubsolv
development programs we are now ready to look ahead and strengthen
our long term product pipeline beyond Zubsolv. We are currently
working on some early internal projects and are evaluating our
opportunities moving forward together with the Board of Directors. My
colleagues at Orexo and I are looking forward to the continued
positive evolution of the company with confidence of an exciting
future for Orexo.

Nikolaj Sørensen
CEO and President

1) For detailed information about the litigation processes against
Actavis please see page 11

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http://news.cision.com/orexo/r/interim-report-january-september-2016,c21...
http://mb.cision.com/Main/694/2104810/577438.pdf

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