Financial summary for the second quarter
-- Net turnover totalled SEK 564.0 million (SEK 40.7 m), of which SEK
500.7 million was contributed by royalties for simeprevir. Revenues from
Medivir's own pharmaceutical sales totalled SEK 62.9 million, SEK 21.7
million of which derived from sales of Olysio and SEK 41.2 million from
sales of other pharmaceuticals. The profit/loss after tax was SEK 327.8
million (SEK -63.7 m).
-- Basic and diluted earnings per share totalled SEK 10.49 (SEK -2.04)
and SEK 10.28 (SEK -2.04), respectively.
-- The cash flow from operating activities amounted to SEK 88.7 million
(SEK -8.3 m), while liquid assets and short-term investments totalled
SEK 430.4 million (SEK 279.9 m) at the period end.
Financial summary for the first six months of the year
-- Net turnover totalled SEK 772.2 million (SEK 218.8 m), of which SEK
662.4 million was contributed by royalties for simeprevir. Revenues from
Medivir's own pharmaceutical sales totalled SEK 109.2 million, SEK 21.7
million of which derived from sales of Olysio and SEK 87.5 million from
sales of other pharmaceuticals. The profit/loss after tax was SEK 611.7
million (SEK 7.5 m).
-- Basic and diluted earnings per share totalled SEK 19.57 (SEK 0.24)
and SEK 19.18 (SEK 0.24), respectively.
-- The cash flow from operating activities amounted to SEK 31.0 million
(SEK -27.2 m), while liquid assets and short-term investments totalled
SEK 430.4 million (SEK 279.9 m) at the period end.
Significant events during Q2
-- Olysio (simeprevir) was approved within the EU for the treatment of
adults with hepatitis C genotype 1 and 4 infection, and was launched by
Medivir in Sweden, Denmark, Norway and Finland.
-- Adasuve was launched in Sweden, Norway, Finland and Denmark.
-- A supplemental New Drug Application for simeprevir in combination
with sofosbuvir was submitted to the US FDA.
-- Final phase II COSMOS study data of simeprevir in combination with
sofosbuvir was presented at EASL.
-- Two phase III trials evaluating combination treatment with simeprevir
and sofosbuvir were initiated.
-- A new Board of Directors was elected at Medivir's Annual General
Meeting and Birgitta Stymne Göransson was elected Chairman of the Board.
-- Suscard was re-launched into the Swedish market.
Significant events after the end of Q2
-- U.S. FDA granted Priority Review for simeprevir in combination with
sofosbuvir supplementary New Drug Application.
-- Respiratory Syncytial Virus drug program was licensed from Boehringer
-- Medivir's Board of Directors has appointed Niklas Prager as new
President and CEO of Medivir effective 1 September 2014.
* All figures refer to the Group, unless otherwise stated. Comparisons
in the Interim Report are, unless otherwise stated, with the
corresponding period in 2013. Cross Pharma was divested from the Group
on 30 June 2013.
The CEO's comments on Q2 2014
Medivir launched Olysio (simeprevir) in the Nordic region and
received SEK 500.7 million in royalty income
We can now look back on a very successful quarter, both in terms of
revenues and of results and activities. Medivir's royalty income for the
period from the global sales of simeprevir totalled SEK 500.7 million,
demonstrating the continued strong growth in Janssen's sales of
simeprevir during the second quarter.
The period saw our most important market launch to date with the launch
of simeprevir, which is marketed under the name of Olysio in the Nordic
region. In May, the European Commission granted marketing approval for
the pharmaceutical for the treatment of adult patients with chronic
hepatitis C, and physicians in all of the Nordic countries have since
begun prescribing Olysio, primarily as an interferon- and ribavirin-free
combination treatment with Sovaldi (sofosbuvir).
The marketing authorisation in Europe is an important milestone in our
history and it provides clear confirmation of Medivir's successful
research and technological platform on which to base our development of
protease inhibitors. It also provides proof that Medivir has the ability
to collaborate successfully with global pharmaceutical partners, which
is a key prerequisite if we are to achieve sustainable profitability.
Revenues from our Nordic pharmaceutical sales totalled SEK 62.9 million,
SEK 21.7 million of which derived from sales of Olysio and SEK 41.2
million from sales of other pharmaceuticals. Sales of other
pharmaceuticals continued stable in relation to the comparison quarter.
Our partner, Janssen, initiated two interferon-free phase III trials in
April, in order to continue its development of interferon-free
treatments for hepatitis C. These trials will treat patients with a
combination of simeprevir and sofosbuvir for 8 or 12 weeks. Janssen also
submitted a supplementary New Drug Application for simeprevir in
combination with sofosbuvir to the US FDA. The application is based on
data from the phase II study, COSMOS, and it is an important component
of the efforts to enhance simeprevir's competitiveness in the US market.
The past quarter also saw the launch in the Nordic region of the new
pharmaceutical, Adasuve, for the treatment of agitation in patients with
schizophrenia or bipolar disorder. Adasuve is the first inhalable
treatment for agitation. We also re-launched Suscard in the Swedish
market. Suscard is a pharmaceutical for the treatment of angina pectoris
- one of the Western World's most common cardiac diseases. The
pharmaceutical has been unavailable in Sweden for the past two years,
during which time demand for the treatment from patients and physicians
alike has been substantial.
The addition of innovative specialist pharmaceuticals to the Nordic
product portfolio is part of Medivir's commercial strategy, and the
launches of Olysio and Adasuve are important steps in this direction.
Medivir's in-house research and development projects involving cathepsin
K and S and the nucleotide project are continuing to progress according
to plan and we are continuously evaluating potential partnership
strategies. We strengthened our R&D portfolio in August when we licensed
a Respiratory Syncytial Virus drug program from Boehringer Ingelheim.
Under the terms of the agreement Medivir receives an exclusive, global
license to research, develop, manufacture and commercialise future RSV
On 1 September, I will be handing the baton on to Niklas Prager. I am
proud of what we have achieved together at Medivir during my time as the
Group's President & CEO, and I wish Niklas and all of his colleagues
every success with what I am sure will be their continued successful
development of the company.
President & CEO
Conference call for investors, analysts and the media
The Interim Report for the second quarter of 2014 will be presented by
Medivir's CEO, Maris Hartmanis, and members of the management group.
Time: Thursday, 21 August 2014 at 14.00 (CET).
Phone numbers for participants from:
Sweden +46 (0)8 519 990 30
Europe +44 (0)20 766 020 77
USA +1 877 788 9023
The conference call will also be streamed via a link on the website: www.medivir.com
The Interim Report for January-September will be published on 20
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