Interim report, January-December 2012

OREXO IS PREPARING ZUBSOLV™ FOR LAUNCH IN THE USA - DRUG APPLICATION ACCEPTED BY
FDA WITH A JULY 6, 2013 TARGET APPROVAL DATE
Unless otherwise stated in this report, all data refers to the Group. Figures in
parentheses relate to the corresponding period in 2011.

During the year

  · Net revenues amounted to MSEK 326.3 (199.6).
  · Net revenues from launched products increased by 102 percent to MSEK 267.1
(132.4).
  · Earnings after tax were MSEK -85.9 (-392.0).
  · Earnings per share were SEK -2.92 (-14.43).
  · Cash flow from operating activities amounted to MSEK 28.7 (-117.2).
  · Cash and cash equivalents amounted to MSEK 228.1 (246.9).
  · The licensing agreement with ProStrakan was renegotiated. ProStrakan/Kyowa
Hakko Kirin retain the rights outside the USA and Orexo obtains the rights to
Abstral in the USA and receives MSEK 610 in fixed royalties.
  · In June Edluar®, for treatment of short-term insomnia, was approved in
Europe.
  · During the third quarter Orexo bought back company’s own shares, in total
amounting to MSEK 53.
  · In October, Orexo engaged Guggenheim Securities as financial advisor to
explore different commercial partnership solutions for Zubsolv and Abstral in
USA.
  · A dose-finding phase II study was initiated in October for OX51, for the
prevention of procedure-induced pain.
  · In November, Kyowa Hakko Kirin submitted a New Drug Application for KW-2246
(Abstral) in Japan.
  · In September, a New Drug Application for Zubsolv was submitted to the FDA.
The application was accepted for review by the FDA in November and the planned
date for notification of approval is July 6, 2013.

After the end of the year

  · Orexo entered into a research agreement with AstraZeneca for respiratory
disease OX-CLI program.

Teleconference
CEO Anders Lundström and CFO Carl-Johan Blomberg will present the report at a
teleconference today at 10:00 a.m. CET. Presentation slides are available via
the link and on the website. Internet:
http://livecast.wehay.com/playontv/130131/orexo/
Telephone: +44 (0) 20 3003 2666 - Standard International Access; 020 089 6377 -
Stockholm Toll Free; 0808 109 0700 - UK Toll Free; 1 866 966 5335 - USA Toll
Free)



CEO’s comments

2012 was a successful year for Orexo. The most important event was the
submission of the New Drug Application for Zubsolv™ (buprenorphine/naloxone) in
the USA.

Zubsolv is a product for treatment of opioid dependence, a huge medical and
societal problem in the USA. The current buprenorphine/naloxone market value is
$1.5 billion and growing steadily. Zubsolv can be the first new improved product
in this market.

In November FDA accepted the application for further review and we anticipate
notification of approval in July 2013. Based on this anticipation, we focus more
or less the entire company resources towards a launch of Zubsolv in the US
market in September 2013. This comprises scaling up the manufacturing capacity
in Sweden and the USA, the completion of a Zubsolv preference study with
convincing results compared to the market leader Suboxone® Film and the
preparation of three new clinical studies, all of which will start in the first
half of 2013, with the aim to differentiate Zubsolv from competitors and to
expand the label.

We are also working on creating a stronger product line for Zubsolv by
developing a new taste and an expanded dose range of the current Zubsolv
formulation. Furthermore, we are evaluating different strategic and commercial
options for a successful commercialization in the US and we expect to have this
in place well ahead of the launch.

I am very pleased that we successfully renegotiated the Abstral® agreement with
ProStrakan. The new agreement gives us fixed royalty revenues from Abstral sales
outside the US of SEK 610 million plus the right to earn additional royalties
when certain sales levels are reached. At the same time Orexo obtains the rights
to Abstral in the USA as from July 2013. In parallel to the preparation of the
Zubsolv launch we are also actively evaluating the best commercial solution for
Abstral in the US, and we will have this in place before July 2013.

During 2012 we have strengthened Orexo’s financial position and reduced cost
levels. The success in these efforts has given us a good basis for generation of
considerable revenues in the future. I look forward to developments during 2013
with confidence. With the current assumption of a regulatory approval of Zubsolv
in July and subsequent launch in September 2013, we project that Orexo will turn
profitable in late 2013 and cash flow positive in 2014.

Anders Lundström
President and CEO



For further information, please contact:
Anders Lundström, CEO, tel: +46 (0)706 67 22 66, e-mail:
anders.lundstrom@orexo.com
Carl-Johan Blomberg, CFO, tel: +46 (0)706 33 67 11, e-mail: carl
-johan.blomberg@orexo.com



Please note
Orexo AB publ discloses the information provided herein pursuant to the
Securities Markets Act. The information was provided for public release on
January 31, 2013, at 8:00 a.m. This report has been prepared in both Swedish and
English. In the event of any discrepancy in the content of the two versions, the
Swedish version shall prevail.