Interim report January-September 2013

Unless otherwise stated in this report, all data refers to the Group. Figures in
parentheses relate to the corresponding period in 2012.

Zubsolv® - successfully launched in the US on September 16

During the period

  · Net revenues amounted to MSEK 329.9 (242.7).
  · Revenues from launched products increased by 69 percent to MSEK 321.8
(190.1).
  · Earnings after tax were MSEK -117.1 (-63.6). Earnings include impairment of
MSEK 43.9 for OX‑NLA during the second quarter. The project has been licensed to
Meda since 2008.
  · Earnings per share were SEK -3.97 (-2.14).
  · Cash flow from operating activities amounted to MSEK -150.3 (105.5).
  · Cash and cash equivalents amounted to MSEK 91.9 (306.2).
  · Zubsolv was approved by the FDA and launched in the US on September 16.
  · Three studies were initiated for Zubsolv regarding early and long-term
effects and how well patients comply with treatment.
  · Convertible bonds subscribed for by Novo A/S converted.
  · OX51 phase II study for the prevention of pain in connection with surgical
procedures completed.
  · Sponsored Level 1 ADR program initiated in the US (symbol ORXOY on the OTC
market).
  · Abstral® approved in Japan.
  · Henrik Juuel appointed new CFO.

Guidance
The previously communicated guidance for Q4 2013 remains unchanged. A positive
EBIT for Q4 2013 is still expected.

+-----------------------------------+-------+-------+-------+-------+-------+
|MSEK                               |   2013|   2012|   2013|   2012|   2012|
+-----------------------------------+-------+-------+-------+-------+-------+
|                                   |Jul-Sep|Jul-Sep|Jan-Sep|Jan-Sep|Jan-Dec|
+-----------------------------------+-------+-------+-------+-------+-------+
|Net revenues                       |  121.1|   76.1|  329.9|  242.7|  326.3|
+-----------------------------------+-------+-------+-------+-------+-------+
|Revenues from launched products    |  116.8|   73.9|  321.8|  190.1|  267.1|
+-----------------------------------+-------+-------+-------+-------+-------+
|EBIT                               |  -25.5|  -29.2| -107.9|  -57.7|  -79.4|
+-----------------------------------+-------+-------+-------+-------+-------+
|EBIDTA                             |  -24.0|  -27.7|  -60.0|  -52.5|  -62.1|
+-----------------------------------+-------+-------+-------+-------+-------+
|Earnings after tax                 |  -28.9|  -30.8| -117.1|  -63.6|  -85.9|
+-----------------------------------+-------+-------+-------+-------+-------+
|Earnings per share                 |  -0.94|  -1.05|  -3.97|  -2.14|  -2.92|
+-----------------------------------+-------+-------+-------+-------+-------+
|Cash flow from operating activities| -229.9|  -66.9| -150.3|  105.5|   28.7|
+-----------------------------------+-------+-------+-------+-------+-------+
|Cash and cash equivalents          |   91.9|  306.2|   91.9|  306.2|  228.1|
+-----------------------------------+-------+-------+-------+-------+-------+

Teleconference
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a
teleconference today at 2 p.m. CET. Presentation slides are available via the
link and on the website.
Internet: http://financialhearings.nu/131023/orexo/
Telephone: SE: +46851999359, UK: +442076602077, US: +18557161598

For further information, please contact:
Nikolaj Sørensen, CEO, tel: +46 (0)703 50 78 88, e-mail:
nikolaj.sorensen@orexo.com
Henrik Juuel, EVP and CFO, tel: +46 (0)722 20 94 77, e-mail:
henrik.juuel@orexo.com

CEO’s comments

In the half-year report, we communicated that we received the formal FDA
approval for Zubsolv® in the US just a few days into the third quarter. Once
approval had been secured, intense launch preparations were further accelerated,
including setting up a U.S. subsidiary and creating awareness of Zubsolv with
key customers. Comprehensive and extensive preparations and the recruiting of a
highly competent and experienced team in the US enabled Zubsolv to be launched
in September with reimbursement for more than 70% of current patients in the
market. Moreover, approximately 11,000 pharmacies pre-ordered Zubsolv, for
stocking purposes, ensuring a readiness to meet the demand for Zubsolv. It is a
significant accomplishment for Orexo to have been able to set up an entire
commercial organization and secure the supply of Zubsolv across the US in the
course of just a few months. I am proud of my many colleagues who have worked
intensely all summer to make this happen.

The foundation for the launch of Zubsolv has now been laid and we begin the
exciting work of gaining market share and improving treatment of opioid
dependence. The feedback from patients and prescribing physicians, that I have
received, has been positive, even if many prescribing physicians first want to
test the product on a few patients before they begin to use Zubsolv more widely.
Many important prescribing physicians have already come back to us with
promising feedback and I anticipate seeing rapidly increasing sales during the
fourth quarter and accelerating during 2014.

A key factor for the continuing success of Zubsolv is to secure competitive
reimbursement conditions. I see good progress in the on-going negotiations
indicating significant improvement in reimbursement during Q1 2014 for both
commercial and public plans. I am awaiting final outcome of pricing reviews
scheduled by most payers during Q4 2014 and I expect to see the first
significant improvements in reimbursement late this year. I see no signals of
Zubsolv being without reimbursement for the major commercial and public plans
and I expect restrictions in prescriptions to be limited to a few, primarily
public plans. I am certain that many patients will shortly have access to
Zubsolv with similar reimbursement to our competition.

The launch of Zubsolv two weeks before the end of the quarter naturally entails
only a small effect on sales for the quarter, but I am following the development
of sales in the US closely. The focus of the US team is to get the high
-prescribing physicians to start prescribing Zubsolv, in anticipation of 2014
and for future growth of the product.

The first nine months of 2013 have been rewarding for the Orexo team as our hard
work has begun to bear fruit. Our journey as a fully integrated specialty
pharmaceutical company is now in full bloom, and I look forward to leading Orexo
as a top tier organization improving treatment for millions of people suffering
from opioid dependence.

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 October 23, 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.