Unless otherwise stated in this report, all data refers to the Group. Figures in
parentheses relate to the corresponding period in 2014.
Zubsolv® growth driven by patient and physician choice
Third quarter 2015
· Total net revenues amounted to MSEK 139.5 (130.7).
· Zubsolv net revenue amounted to MSEK 110.8 (68.4).
· Earnings after tax were MSEK -46.1 (-36.8).
· Earnings per share were SEK -1.33 (-1.13).
· Cash flow from operating activities amounted to MSEK -79.5 (-152.1).
· Zubsolv excluded from CVS Caremark preferred position in 2016 after closed
tender process.
· New exclusive agreement with unnamed Pharmacy Benefit Manager in Managed
Medicaid.
· FDA approved Zubsolv for induction treatment of opioid dependence.
· U.S. Department of Health and Human Services announced intention to expand
patient access to treatment of opioid dependence.
January - September 2015
· Total net revenues amounted to MSEK 415.0 (349.8).
· Zubsolv net revenue amounted to MSEK 296.4 (148.5).
· Earnings after tax were MSEK -146.2 (-108.2).
· Earnings per share were SEK -4.24 (-3.37).
· Cash flow from operating activities amounted to MSEK -108.5 (-480.0).
· Cash and cash equivalents amounted to MSEK 201.2 (299.2).
· Orexo broadened Zubsolv product range by launching Zubsolv 8.6 mg/2.1 mg.
· Orexo announced newly listed granted US patent.
· Orexo commenced patent infringement litigation against Actavis concerning
Abstral® in the US.
· New clinical data established Zubsolv as effective, well tolerated for
maintenance treatment of opioid dependence and increases patients’ work
productivity.
· Orexo divested the subsidiary Kibion; short term negative net impact of MSEK
-5.3 on EBIT.
· FDA approved the medium tablet strength, 2.9 mg/0.71 mg, of Zubsolv.
· Orexo settled patent infringement litigation against Mylan regarding
Edluar®.
After the period: Nothing to report.
MSEK 2015 2014 2015 2014 2014
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Jan-Dec
Net revenues 139.5 130.7 415.0 349.8 570.3
EBIT -39.4 -29.3 -124.7 -84.0 -25.0
EBITDA -33.9 -26.8 -113.1 -76.6 -12.5
Earnings after tax -46.1 -36.8 -146.2 -108.2 -56.6
Earnings per share, SEK -1.33 -1.13 -4.24 -3.37 -1,73
Cash flow from operating activities -79.5 -152.1 -108.5 -480.0 -487.3
Cash and cash equivalents 201.2 299.2 201.2 299.2 284.5
Teleconference:
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a
teleconference today at 2:00pm CET.
Presentation slides are available via the link and on the website.
Internet: http://financialhearings.nu/151022/orexo/
Telephone: + 46 856642693 (SE), + 44 2034281434 (UK) or +1 6465025118 (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 third quarter has been eventful for Orexo. Overall the quarter has developed
in a positive direction, even if the decision by the Pharmacy Benefit Manager
(PBM) CVS Caremark in August to remove Zubsolv® from the preferred formulary was
a short term setback. For the medium and long term, the most important and
encouraging news for Zubsolv’s growth potential was the announcement of plans by
the US Government to expand access to treatment of opioid dependence in the US
and the FDA approval of Zubsolv for use at initiation of treatment for opioid
dependence (Induction) on August 11th.
We are encouraged by Zubsolv’s positive growth in demand and market share during
the third quarter. The demand for Zubsolv grew by 6 percent[1] (http://#_ftn1)
and the market share increased by 0.3 percentage points to 6.2 percent. The main
growth drivers were the profitable non-exclusive commercial and cash segments.
These segments are associated with lower rebates, and in combination with growth
and stable inventory levels at the wholesalers, net sales of Zubsolv grew by 22
percent compared to Q2.
Since the launch of Zubsolv, we have repeatedly highlighted the significant
patient need for increased access to treatment. We therefore welcome the
initiative from the United States Department of Health and Human Services’ (HHS)
Secretary Sylvia M. Burwell, to improve patient access to medication assisted
treatment. The actual changes to the legislation are yet to be disclosed. We
anticipate this increase in access to be ruled upon later this year or early
next year. The ambition level indicates that the changes will have substantial
positive impact on the access to treatment in the long term. To cite Secretary
Burwell: “Despite the evidence supporting the clinical efficacy of MAT (Medical
Assisted Treatment) for the treatment of opioid use disorders, it is highly
underutilized”. An expansion to MAT is anticipated to have positive effect on
patient wellbeing, market dynamics and growth opportunities for Zubsolv long
term.
During the third quarter, we signed two framework agreements with PBMs, enabling
an improved position in large public plans. These two agreements can potentially
more than compensate for the market share loss from CVS Caremark during 2016. We
announced one of these in August and the other one was signed later in the
quarter. We continue to have a constructive dialog with several major payer
organizations and expect further improvements in market access in the fourth
quarter.
I am personally satisfied that we during the third quarter continued to improve
our commercial position through the new approval of the induction label,
increasing sales and market share, new market access agreements further
supported by the future significant improvement in the market conditions with
the anticipated changes in the legislation in the US. Our efforts to find a
partner for Zubsolv outside the US and our exciting project OX-51 continue to
progress well. We are confident that we will find partners for these two
products further strengthening Orexo’s long term growth opportunities.
Nikolaj Sørensen
President and CEO
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[1] (http://#_ftnref1) All sales data is IMS weekly prescription data using four
week rolling averages for market share and growth.
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 22, 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.
Interim report January-February 2015
| Source: Orexo AB
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