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Medivir: Financial Statement, 1 January - 31 December 2012*
HUDDINGE, Sweden --(Business Wire)--
Regulatory News:
Medivir (STO:MVIR-B):
Press release, 22 February 2013
Full-year (January - December)
· Net turnover totalled SEK 555.0 million (SEK 698.6 m).
· The profit/loss after tax was SEK -219.1 million (SEK 113.8 m).
· Basic and diluted earnings per share totalled SEK -7.01 (SEK 3.80).
· The cash flow from operating activities amounted to SEK -139.5 million
(SEK 57.3 m), while liquid assets and short-term investments totalled
SEK 296.7 million (SEK 536.3 m) at the period end.
· Phase III trials of simeprevir or telaprevir in combination with
pegylated interferon and ribavirin began.
· Two interferon-free phase II combination trials began: simeprevir in
combination with daclatasvir and simeprevir in combination with
TMC647055.
· A clinical phase I trial of Medivir's in-house developed cathepsin
K-inhibitor, MIV-711, began.
· Medivir gained preclinical research programmes in the antiviral sphere
through the acquisition of assets from Novadex.
· Medivir's partner, GSK, began the OTC launch of the Xerclear cold sore
pharmaceutical in Europe under the Zoviduo and Zovirax Duo brand names.
· A partnership to develop new pharmaceuticals for the treatment of
bacterial infections was launched with the Swedish University of
Agricultural Sciences (SLU).
Q4 (October - December)
· Net turnover totalled SEK 155.5 million (SEK 131.8 m).
· The profit/loss after tax was SEK -65.3 million (SEK -53,1 m).
· Basic and diluted earnings per share totalled SEK -2.09 (SEK -1.70).
· Part two of the interferon-free phase II trial of simeprevir and
sofosbuvir was initiated.
· Positive, robust results from three pivotal phase III trials of
simeprevir in combination with pegylated interferon and ribavirin were
presented.
· A phase III trial of simeprevir in combination with pegylated
interferon and ribavirin began in China.
Significant events after the end of the Q4
· A non-exclusive collaborative agreement was concluded between Janssen
and Idenix for phase II combination trials of simeprevir, TMC647055 and
IDX719. The collaboration intends to evaluate a fully oral,
interferon-free, antiviral combination therapy for the treatment of
hepatitis C.
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CONSOLIDATED EARNINGS TREND
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2012
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2011
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2012
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2011
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SUMMARY, SEK m
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Oct-Dec
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Oct-Dec
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Jan-Dec
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Jan-Dec
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Net turnover
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155.5
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131.8
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555.0
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698.6
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Gross profit
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45.6
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35.1
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152.3
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458.0
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Operating profit/loss before depreciation and amortisation (EBITDA)
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-39.9
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-35.7
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-150.9
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135.3
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Operating profit/loss (EBIT)
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-48.5
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-44.1
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-185.8
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111.9
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Profit/loss before tax
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-50.0
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-47.5
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-193.0
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111.2
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Profit/loss after tax
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-65.3
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-53.1
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-219.1
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113.8
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Operating margin
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-31.2%
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-33.6%
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-33.5%
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16.0%
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Basic and diluted earnings per share, SEK
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-2.09
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-1.70
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-7.01
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3.80
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The CEO's round up of 2012
"The year ended with positive phase III data for Simeprevir"
The year was characterised by a number of important events, but perhaps
the foremost of these was the announcement of positive, robust phase III
data for simeprevir. The results show, among other things, that
treatment with simeprevir results in a high percentage of cured patients
and in a reduction in the treatment duration from 48 weeks to 24 weeks
for the majority of patients, with no incremental side effects. We
expect to submit an application for the market registration of
simeprevir in triple combination with pegylated interferon and ribavirin
during the first half of 2013. The next goal is to develop an oral,
fully interferon-free, direct-acting antiviral combination therapy for
hepatitis C and the past year saw three clinical partnership agreements
concluded in order to evaluate simeprevir in various interferon-free
therapies. Simeprevir, which is the most advanced of our R&D pipeline
products, is not our only research project. The internal projects are
moving towards a range of subsidiary goals and 2012 saw work begin, for
example, on the clinical development of MIV-711 for the treatment of
osteoarthritis and osteoporosis. We also strengthened our research
organisation by the recruitment of a number of specialists and enhanced
our ability to evaluate new project concepts.
The company's business operations
Our pharmaceutical sales were stable and showed good profitability, with
Mollipect, Citodon, Lithionit, Laxabon and Paraflex generating the best
sales during the year. In 2013, we will be preparing for a potential
market introduction of simeprevir in the Nordic region in 2014 -
preparations that will include strengthening our presence in the Nordic
market with Medivir personnel in each country. The cold sore compound
that we have developed was launched in five European OTC markets in 2012
and was also approved for launch in Russia. The launch is being driven
by our partner, GSK, and the compound is being sold under the Zoviduo
and Zovirax Duo brand names.
Research and Development (R&D)
· Focus on hepatitis C research
Simeprevir is administered in tablet form (150 mg) once a day and is one
of the next generation of protease inhibitors. The phase III trials of
simeprevir reported in December involve triple treatment with simeprevir
in combination with pegylated interferon and ribavirin. Simeprevir has
displayed distinguishing properties that make it an ideal pharmaceutical
for a future interferon- and ribavirin-free combination therapy and
simeprevir will, therefore, also be evaluated in five interferon-free
trials. We are looking forward to the results of these trials which will
be presented continuously throughout the year. Our two internally-driven
hepatitis C projects also made good progress and the acquisition of
Novadex's assets has strengthened our position in the field of antiviral
diseases in the form of new polymerase inhibitors and prodrug technology.
· Other projects
Testing of our in-house developed cathepsin K-inhibitor (MIV-711) for
the treatment of skeletal disorders began as part of phase I trials
during the year. The results of the trials are expected during the
latter half of 2013 and our ambition is then to develop the project
through partnerships or outlicensing. A range of different preclinical
models yielded new and promising results in the cathepsin S project for
the treatment of neuropathic pain and we hope to be able to select a new
candidate drug in this sphere during the first half of 2013. We also
initiated a partnership with the Swedish University of Agricultural
Sciences for the development of new antibiotics to treat drug-resistant
bacteria. Antibiotic resistance is an important field and there is
substantial demand for new, effective antibiotics.
Parallel imports via Cross Pharma
This portfolio comprised approximately 120 different pharmaceuticals at
the end of the year. The product portfolio was expanded in 2012 and a
range of activities carried out in order to strengthen our position at
the Swedish pharmacy chains.
The future
We are convinced that the coming year will be an eventful one. We expect
to submit a registration application for simeprevir in the USA, Europe
and Japan during the first half of 2013 and are making preparations
aimed at generating the optimum preconditions for our own launch in the
Nordic region during the first half of 2014. We are looking forward to
receiving a continuous stream of data from the interferon-free trials of
simeprevir and are optimistic about the possibility of participating in
the development of a future interferon-free treatment. Our R&D pipeline
is strong and we are confident about the potential for progressing our
internal projects during the year and seeking out partnerships that will
enable continued clinical trials and further development of our projects.
Maris Hartmanis
President & CEO
Conference call for investors, analysts and the media
The Financial Statement for 2012 will be presented by the CEO, Maris
Hartmanis, and members of Medivir's management group.
Time: Friday, 22 February 2013 at 15.00 (CET)
Phone (News - Alert) numbers for participants from:
Sweden +46 (0)8 505 204 24
Europe +44 (0) 20 3003 2666
USA +1 866 966 5335
The conference call will also be streamed live via a link on the
website: www.medivir.se
Financial calendar, 2013
The Interim Report for January-March will be published on 6 May
The Annual General Meeting will be held on 6 May
The Interim Report for January-June will be published on 22 August
This information was brought to you by Cision http://news.cision.com

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