Unless otherwise stated in this report, all data refers to the Group. Figures in
parentheses relate to the corresponding period in 2014.
2015 – a year of investments and growth. Zubsolv® revenue growth of
83 percent.
Fourth quarter 2015
▪ Total net revenues amounted to MSEK 228.3 (220.5).
▪ Zubsolv net revenue amounted to MSEK 120.3 (79.5).
▪ Earnings after tax were MSEK -51.8 (51.6).
▪ Earnings per share were SEK -1.50 (1.50).
▪ Cash flow from operating activities amounted to MSEK 6.3 (-7.3).
▪ Orexo received MGBP 5 milestone payment for Abstral® in Europe.
▪ Orexo recorded OX-MPI non-cash impairment charge of MSEK 62.
▪ Orexo announced new Abstral partner in the US.
▪ Orexo settled Abstral US patent litigation with Actavis.
▪ Orexo filed for FDA approval of new Zubsolv low dose.
January-December 2015
▪ Total net revenues amounted to MSEK 643.3 (570.3).
▪ Net revenues, adjusted 1), were MSEK 586.3 (396.7), up by 47.8 percent.
▪ Zubsolv net revenue amounted to MSEK 416.7 (228.0).
▪ Earnings after tax were MSEK -198.0 (-56.6).
▪ Earnings per share were SEK -5.74 (-1.73).
▪ EBITDA, adjusted 1), were MSEK -145.3 (-186.1), an improvement of MSEK
40.8.
▪ Cash flow from operating activities amounted to MSEK -102.2 (-487.3).
▪ Cash and cash equivalents amounted to MSEK 198.1 (284.5).
▪ Orexo broadened Zubsolv product range.
▪ FDA approved Zubsolv for induction treatment of opioid dependence.
▪ New clinical data established Zubsolv as effective, well tolerated for
maintenance treatment of opioid dependence and increases patients’ work
productivity.
▪ Zubsolv excluded from CVS Caremark preferred position effective from
January 1, 2016 after closed tender process.
▪ New exclusive agreement with unnamed Pharmacy Benefit Manager in Managed
Medicaid.
▪ Orexo divested the subsidiary Kibion.
▪ Orexo settled patent infringement litigation against Mylan regarding
Edluar®.
MSEK 2015 2014 2015 2014
Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Net revenues 228.3 220.5 643.3 570.3
Revenues from launched products 228.3 220.5 643.3 568.6
EBIT -44.3 59.0 -169.0 -25.0
EBITDA 24.8 64.1 -88.3 -12.5
Earnings after tax -51.8 51.6 -198.0 -56.6
Earnings per share before dilution, SEK -1.50 1.50 -5.74 -1.73
Cash flow from operating activities 6.3 -7.3 -102.2 -487.3
Cash and cash equivalents 198.1 284.5 198.1 284.5
Key figures adjusted for non-cash fixed Abstral® royalty 1)
MSEK 2015 2014 2015 2014
Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Net revenues, adjusted 1) 228.3 186.0 586.3 396.7
EBITDA, adjusted 1) 24.8 29.6 -145.3 -186.1
1) The non-cash fixed Abstral royalty represents an amortization of fixed and
unconditional payments received in connection with the 2012 agreement with
ProStrakan. This was fully recognized in the P&L by May 2015.
Teleconference
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a
teleconference on January 28, 2016 at 2:00 p.m. CET (08:00 a.m. EDT).
Presentation slides are available via the link and on the website.
Internet: http://financialhearings.nu/160128/orexo/
Telephone: 46 8 566 42652 (SE), +44 203 426 2845 (UK) or +1 347 329 1282 (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 United States consume 80 percent of the world’s opioids, but only account
for 4.6 percent of the world’s population and the amount of opioid painkillers
prescribed is enough to medicate every single adult in the country for one
month. The consequences, when opioids are abused, on the society is severe and
in 2014, 28,647 people died from drug overdose with
opioids[1] (http://connect.ne.cision.com#_ftn1) in the US. This a tripling since
year 2000 and has created an outcry in major media in the US e.g. the cover page
of the first Newsweek® of 2016 read “Why Are White Americans Dying Younger?”,
with the answer being the prescription opioid epidemic.
Since the initiation of our commercial journey for Zubsolv®, we have highlighted
the significant unmet need for opioid dependence treatment. More than 10 million
Americans are using opioids for non-medical purposes and less than 1 million
receiving any type of treatment today. The need for actions from the authorities
in the United States is imminent and this was one of the first topics raised by
President Obama in his final State of the Union speech. We know several concrete
improvements are being evaluated, one being how to double the amount of
prescribers in this disease space (2). We have anticipated this type of change
and it has been an integral part of our business plans since we decided to
establish a commercial entity in the US. Two years into our commercial journey
in the US, we finally see concrete steps in the right direction for the patients
and for Orexo and this give me strong confidence in the journey have ahead of
us.
In a market facing dramatic changes, being at the forefront in terms of
scientific documentation and developing a product range, providing the optimal
convenience and flexibility for patients and physicians are important
competitive differentiators. Thus, I am happy to report our registry study
REZOLV is about to finalize the patient recruitment with more than 1,000
patients enrolled by the end of 2015. Also our product development has
progressed and we launched two new tablet strengths in the fourth quarter.
However, when I met physicians during the launch of these new tablets, they
inquired about a tablet with lower strength to improve their ability to tapering
down with Zubsolv. Thus, I am pleased to report that we have filed for approval
a new lower dosage in Q4, 2015 and we anticipate FDA approval in Q4, 2016.
While we continue to invest in the growth of Zubsolv, we also continuously
assess where and how to optimize the use of our resources. As a reaction to the
change in market access from January 1, 2016 we have made an adjustment in the
sales force in selected geographies. This will increase efficiency and enable a
focus where our presence has the highest return on investment potential. One
such region is the State of New York where we won an exclusive regional contract
to be implemented in March 2016. We will ensure we have sufficient resources in
this region to optimize the value of this contract. Another important driver of
the profitability of our commercial investments, is the price and I am pleased
to report we have been able to increase the price of Zubsolv in January 2016.
Our efforts to find a partner for Zubsolv outside the US and for our project OX
-51 continue to progress well. We expect to finalize the full license agreement
for Zubsolv outside the US in the first half of 2016. Like we have seen with
Abstral® in Europe, the right partner for Zubsolv will further strengthening
Orexo’s long term growth opportunities.
Nikolaj Sørensen
President and CEO
1 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=mm6450a3_w
2 Huffington Post, Oct 21, 2015.
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 28, 2016, at 8:00 a.m.
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.
Full year report January-December 2015
| Source: Orexo AB
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