Unless otherwise stated in this report, all data refers to the Group. Figures in
parentheses relate to the corresponding period in 2013.
Positive results from clinical trials with Zubsolv®
Second quarter 2014
· Total net revenues amounted to MSEK 117.3 (69.0). Revenues from launched
products, excluding one-off milestones, amounted to MSEK 115.6 (68.6). Revenue
recognition approach for Zubsolv changed from the second quarter.
· Earnings after tax were MSEK -50.2 (-115.7).
· Earnings per share were SEK -1.58 (-4.00).
· Cash flow from operating activities amounted to MSEK -228.2 (84.4).
· Orexo completed issue and listing of a MSEK 500 unsecured bond.
· inVentiv Health selected as new partner for the commercialization of Zubsolv
in the US.
· Positive results from two phase 3 clinical trials assessing Zubsolv for
induction of buprenorphine maintenance therapy.
· Top-line data from a phase 3 clinical trial demonstrated that Zubsolv is as
effective as Suboxone® film in the treatment of opioid dependence.
· Orexo commenced patent infringement litigation against Actavis.
First half 2014
· Total net revenues amounted to MSEK 219.1 (208.8). Revenues from launched
products, excluding one-off milestones, amounted to MSEK 217.4 (140.7).
· Earnings after tax were MSEK -71.4 (-88.2).
· Earnings per share were SEK -2.24 (-3.05).
· Cash flow from operating activities amounted to MSEK -328.0 (79.4).
· Cash and cash equivalents amounted to MSEK 110.6 (300.7).
· Reimbursement agreement for Zubsolv signed with UnitedHealth Group and
OptumRx.
MSEK 2014 2013 2014 2013 2013
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
Net revenues 117.3 69.0 219.1 208.8 429.4
Revenues from launched products 115.6 68.6 217.4 205.0 421.6
EBIT -38.4 -112.7 -54.7 -82.4 -139.7
EBITDA -35.9 -67.5 -49.8 -36.0 -89.1
Earnings after tax -50.2 -115.7 -71.4 -88.2 -154.9
Earnings per share, SEK -1.58 -4.00 -2.24 -3.05 -5.16
Cash flow from operating activities -228.2 84.4 -328.0 79.4 -265.8
Cash and cash equivalents 110.6 300.7 110.6 300.7 105.6
Teleconference
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a
teleconference today at 1:00pm CET.
Presentation slides are available via the link and on the website.
Internet: http://financialhearings.nu/140711/orexo/
Telephone: +46 8 519 993 53 (SE), +44 20 766 020 77 (UK) or +1 877 788 90 23
(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
The second quarter of 2014 has been another eventful quarter for Orexo. In May,
we issued a MSEK 500 non-secured corporate bond, fully subscribed a few days
after the announcement, showing confidence from investors in our business. Later
the same month, we announced a new commercialization partner, and finally in
June, we finalized two clinical trials (ISTART and 007) with positive results,
further enhancing our ability to differentiate Zubsolv from competitors. In
parallel, Zubsolv® sales volume (tablets, demand) has grown by nearly 20% from
the first quarter and Zubsolv has started to gain market share again.
The major achievement during the quarter was the finalization and positive
outcome of two of our clinical trials with Zubsolv. Short term, the studies will
provide convincing scientific evidence of the equivalent efficacy of Zubsolv,
despite a 29% lower dose of buprenorphine, compared to the leading competitor in
the market. This has been a concern raised by patients and prescribers during
the launch phase. Long term, the positive results of the combined ISTART and 007
studies in the induction phase of treatment for opioid dependence, can provide
Zubsolv with additional differentiation from generic alternatives. We plan to
submit our application for an expansion of the Zubsolv label to include
induction during the fourth quarter of 2014. The two clinical trials, are, to
our knowledge, the largest ever made in this disease area and underscores the
commitment that Orexo has to advance the quality of treatment of patients
suffering from opioid dependence, based on science, research and development.
In May, we announced a new partnership with inVentiv Health for our commercial
field activities. With the new partnership, we take the full leadership of the
commercialization and all sales managers are employed by Orexo. The change will
enhance our agility and decisiveness in our commercial efforts in the launch of
Zubsolv. I am pleased to announce that all sales representatives selected by
Orexo, who were offered a position, have decided to move to the new contract.
This is an excellent evidence of the commitment to and belief in the
opportunities for Zubsolv, from those who are meeting customers every day in the
field.
We look forward to the second half of 2014, which will jump start with the
implementation of the exclusive agreement with UnitedHealth Group on July 1,
expected to provide an immediate positive impact on Zubsolv revenues. I
personally spend a considerable amount of time in the US, meeting prescribers in
their offices. The feedback I receive from prescribers who have made Zubsolv
their preferred choice, makes me even more convinced of the market potential of
Zubsolv and the value it can bring to patients with the advanced sublingual
tablet formulation, offering patients a choice of treatment with a fast dissolve
time, a pleasant menthol taste and with a 29% lower dose compared to the leading
competitors.
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 July 11, 2014, 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.
Interim report January-June 2014
| Source: Orexo AB
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