Unless otherwise stated in this report, all data refers to the Group. Figures in
parentheses relate to the corresponding period in 2015.
Positive cash flow and EBIT. Expansion of Zubsolv® to new markets and improved
market access position in the US.
Second quarter 2016
· Total net revenues MSEK 188.2 (126.5).
· Zubsolv net revenue MSEK 178.2 (91.1).
· Earnings after tax MSEK 5.0 (-84.6).
· Earnings per share SEK 0.14 (-2.46).
· Cash flow from operating activities MSEK 20.0 (-35.6).
· Cash and cash equivalents MSEK 252.9 (282.1).
· Zubsolv was selected by the State of Maryland as the exclusive preferred
buprenorphine/naloxone agent for the FFS Medicaid Formulary effective July 1,
2016.
· A license agreement was signed with Mundipharma, which obtains ex-US global
rights to Zubsolv. The upfront payment of MEUR 7 (MSEK 65.4) is fully included
as revenue in the quarter. The agreement also includes potential future
royalties and milestone payments.
First half year 2016
· Total net revenues MSEK 339.2 (275.5).
· Zubsolv net revenue MSEK 276.6 (185.6).
· Earnings after tax MSEK -29.5 (-100.1).
· Earnings per share SEK -0.85 (-2.91).
· Cash flow from operating activities MSEK 42.5 (-29.0).
· AstraZeneca acquired all rights to Orexo´s OX-CLI project for MUSD 5 (MSEK
40.8). The agreement also includes potential future royalties and milestone
payments.
Important event after the period
· The United States Department of Health and Human Services (HHS) announced an
increase in the buprenorphine patient cap from 100 to 275.
MSEK 2016 2015 2016 2015 2015
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
Net revenues 188.2 126.5 339.2 275.5 643.3
EBIT 12.1 -77.3 -14.1 -85.4 -169.0
EBITDA 17.2 -74.2 -2.3 -79.3 -88.3
Earnings after tax 5.0 -84.6 -29.5 -100.1 -198.0
Earnings per 0.14 -2.46 -0.85 -2.91 -5.74
share, SEK
Cash flow from 20.0 -35.6 42.5 -29.0 -102.2
operating
activities
Cash and cash 252.9 282.1 252.9 282.1 198.1
equivalents
Teleconference
CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a
teleconference on July 12, 2016, at 2:00pm CET.
Presentation slides are available via the link and on the website.
Internet: https://wonderland.videosync.fi/2016-07-12-orexo-q2report
Telephone: +46 8 566 426 62 (SE), +44 20 300 898 04 (UK) or +1 855 753 2236
(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
During the quarter Orexo attained several important objectives and continues to
build additional financial strength with a positive EBIT and for the second
consecutive quarter a positive cash flow.
I am encouraged by and enthusiastic about the opportunities for Orexo arising
from the announcement the increase in the number of patients each physician can
treat for opioid dependence in the US from 100 to 275. I am confident this
market expansion will benefit Zubsolv® and Orexo.
In light of the expected growth in patient access treatment, I am pleased to
announce that effective July 1st Zubsolv is the only preferred
buprenorphine/naloxone product within the largest Fee For Service (FFS) Medicaid
program in the US, the state of Maryland. The Maryland decision strengthens
Orexo´s and Zubsolv’s position in the increasingly important public segment.
Prior to the implementation of the Maryland agreement and anticipated market
growth following the cap lift, I was pleased to see our net sales of Zubsolv in
the US grow during the quarter by nearly 15 percent compared to Q1, driven by a
mix of increased demand, inventory and improved gross to net ratio.
Opioid dependence is a growing global epidemic and today 20 million people
outside the US are estimated to suffer from the disease. I am looking forward to
a successful partnership with Mundipharma to make Zubsolv available to patients
across the world. For Orexo the priority has been to find a partner with an
international organization covering all of the key markets for Zubsolv and with
a strong track record of successful launch and commercialization of many
products on a global scale. Besides creating value from the launch of Zubsolv
outside the US, we are also expecting other scale effects which will positively
contribute to the creation of value and support our progress towards sustainable
profitability.
I am proud to see that we achieved a positive EBIT and cash flow in this quarter
due to the closure of the Mundipharma agreement and a continued overall improved
financial performance. In this quarter our expenses for the on-going patent
litigation against Actavis in the US have increased, due to the completion of
the trial in the district court of Delaware. We remain confident that the court
will support our claims and the validity of our patents for Zubsolv, enabling us
to fully capitalize on the opportunities materializing this quarter and early
July.
Nikolaj Sørensen
CEO and President
Interim Report January-June 2016
| Source: Orexo AB
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