Full year report January-December 2014


Unless otherwise stated in this report, all data refers to the Group. Figures in
parentheses relate to the corresponding period in 2013.

Zubsolv® continues to gain market share

Fourth quarter 2014

  · Total net revenues amounted to MSEK 220.5 (99.5). Revenues from launched
products, excluding one-off milestones, amounted to MSEK 162.0 (99.5).
  · Earnings after tax were MSEK 51.6 (-37.8).
  · Earnings per share were SEK 1.50 (-1.19).
  · Cash flow from operating activities amounted to MSEK -7.3 (-115.5).
  · Orexo submitted application to FDA for expanded label for Zubsolv®.
  · FDA approved two higher dosage strengths of Zubsolv.
  · Orexo received MGBP 5 milestone payment for Abstral® in Europe.

January-December 2014

  · Total net revenues amounted to MSEK 570.3 (429.4). Revenues from launched
products, excluding one-off milestones, amounted to MSEK 510.1 (310.8).
  · Earnings after tax were MSEK -56.6 (-154.9).
  · Earnings per share were SEK -1.73 (-5.16).
  · Cash flow from operating activities amounted to MSEK -487.3 (-265.8).
  · Completion of issue and listing of a MSEK 500 unsecured bond and private
placement of approx. MSEK 346.5, including all Orexo shares held in treasury by
the company in addition to newly issued shares.
  · Cash and cash equivalents amounted to MSEK 284.5 (105.6).
  · Exclusive reimbursement agreement for Zubsolv entered with UnitedHealth
Group and WellCare.
  · inVentiv Health selected as new commercial partner for Zubsolv in the US
from July 1st.
  · Positive results achieved from two phase 3 clinical trials assessing Zubsolv
for induction of buprenorphine maintenance therapy and top-line data showing
that Zubsolv is as effective as Suboxone® film in the treatment of opioid
dependence.
  · Orexo commenced patent infringement litigation against Actavis concerning
Zubsolv.
  · OX-MPI project was returned to Orexo.
  · Orexo enhanced its commercial focus by placing all manufacturing of Zubsolv
with partners in the US and streamlining operations in Uppsala.

+---------------------------------------+-------+-------+-------+-------+
|MSEK                                   |   2014|   2013|   2014|   2013|
+---------------------------------------+-------+-------+-------+-------+
|                                       |Oct-Dec|Oct-Dec|Jan-Dec|Jan-Dec|
+---------------------------------------+-------+-------+-------+-------+
|Net revenues                           |  220.5|   99.5|  570.3|  429.4|
+---------------------------------------+-------+-------+-------+-------+
|Revenues from launched products        |  220.5|   99.5|  568.6|  421.6|
+---------------------------------------+-------+-------+-------+-------+
|EBIT                                   |   59.0|  -31.7|  -25.0| -139.7|
+---------------------------------------+-------+-------+-------+-------+
|EBITDA                                 |   64.1|  -29.0|  -12.5|  -89.1|
+---------------------------------------+-------+-------+-------+-------+
|Earnings after tax                     |   51.6|  -37.8|  -56.6| -154.9|
+---------------------------------------+-------+-------+-------+-------+
|Earnings per share before dilution, SEK|   1.50|  -1.19|  -1.73|  -5.16|
+---------------------------------------+-------+-------+-------+-------+
|Cash flow from operating activities    |   -7.3| -115.5| -487.3| -265.8|
+---------------------------------------+-------+-------+-------+-------+
|Cash and cash equivalents              |  284.5|  105.6|  284.5|  105.6|
+---------------------------------------+-------+-------+-------+-------+

Teleconference
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a
teleconference on January 29, 2014 at 2:00pm CET (08:00am EDT).
Presentation slides are available via the link and on the website.
Internet: http://financialhearings.nu/150129/orexo/
Telephone: +46 8 566 426 96 (SE), +44 203 428 14 31 (UK) or +1 646 502 51 16
(US).

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
It is with pride that I can report a long list of achievements for Orexo during
2014 accomplished by our colleagues in Sweden and the US. Orexo gained
significantly more traction with Zubsolv in the US and we have successfully
completed the first Zubsolv post-launch clinical trials and product
developments. We have also strengthened the Swedish and the US organizations and
we have created a stronger financial platform by raising nearly SEK 850 million
in additional capital to support launch of Zubsolv and life cycle management
activities.

The main focus during 2014 has been to continue the launch of Zubsolv in the US.
We are proud to see that the brand has reached a market share of nearly 6
percent. Benchmarking the Zubsolv launch to other similar launches of new
formulations of opioids, Zubsolv has been the strongest performing launch since
2011 and with significant margin outperformed the most recent launch in the
Buprenorphine/Naloxone category. A key growth driver has been the continuing
improvement in market access and by the third quarter we completed our objective
of having equal or better access to the market than our leading branded
competitor for more than 50 percent of the market. We have successfully closed
exclusive contracts for patients within CVS/Caremark and United Health Group and
in the fourth quarter with WellCare. These exclusive contracts have been
important in gaining physicians’ and patients’ confidence in Zubsolv and we have
seen many physicians increasing their brand preference for Zubsolv after
initiating treatment with the product following an exclusive contract
implementation. During 2014 we have made a large transition of the sales force,
moving the field force to a new partner and employing all sales managers within
Orexo. Clear benefits from this change in field force structure have
materialized during the fourth quarter, where we have seen consistent
improvements in field force productivity and we have seen the first sales
districts exceeding 15 percent market share and several other now exceeding 10
percent.

To secure the long term growth of Zubsolv, we have continued with extensive
investments in the product. During 2014 we completed two clinical trials and
gained approval for two additional dosage strengths in December. The clinical
trial comparing Zubsolv with our leading competitor, the ISTART study, was
especially important. The study confirmed the patient preference for Zubsolv and
that the two products have a similar clinical effect. This study has gained
positive attention and improved the dialogue with physicians significantly. The
results have enabled us to apply for an expanded label to include induction of
treatment and we have received confirmation from the FDA that the expected
approval date is during the third quarter of 2015.

During 2014, we have strengthened our financial position considerably and with
this strong financial position, we will continue to invest in the development of
the Zubsolv franchise. During 2015 we will seek approval for one additional
dosage strength and plan to initiate at least one new clinical trial. 2015 is
also a year where the work to enable the launch of Zubsolv outside the US will
intensify. Together with colleagues at Orexo in Sweden and the US we are looking
forward to 2015 with great confidence. Our top priority remains securing the
commercial success of Zubsolv, but we are also excited about starting to take
the next steps in the life cycle of Zubsolv, progressing the development of OX51
and evaluating new development projects.

Nikolaj Sørensen
President and CEO

Please note
Orexo AB publ discloses the information provided herein pursuant to the
Financial Instruments Trading Act and/or the Securities Market Act. The
information was provided for public release on January 29, 2015, at 8:00am CET.
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.

Attachments

01292888.pdf