Financial Statement, 1 January – 31 December 2012*

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.
CONSOLIDATED EARNINGS TREND 2012 2011 2012 2011
SUMMARY, SEK m Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Net turnover 155.5 131.8 555.0 698.6
Gross profit 45.6 35.1 152.3 458.0
Operating profit/loss before depreciation and amortisation (EBITDA) -39.9 -35.7 -150.9 135.3
Operating profit/loss (EBIT) -48.5 -44.1 -185.8 111.9
Profit/loss before tax -50.0 -47.5 -193.0 111.2
Profit/loss after tax -65.3 -53.1 -219.1 113.8
Operating margin -31.2% -33.6% -33.5% 16.0%
Basic and diluted earnings per share, SEK -2.09 -1.70 -7.01 3.80

* All figures are for the Group, unless otherwise stated. Comparisons in this Interim Report are, unless otherwise stated, with the corresponding period in 2011. The BioPhausia corporate group is included from 31 May 2011.

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

   
For further information, please contact:

Rein Piir, EVP Corporate Affairs & IR: +46 (0)708 537292
Maris Hartmanis, President & CEO: +46 (0)8 5468 3113

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 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

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About Us

Medivir is a pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitors and nucleotide/nucleoside science and we are dedicated to innovative pharmaceuticals that meet great unmet medical needs. Medivir's clinical pipeline consists of remetinostat for cutaneous T-cell lymphoma, currently in phase II, birinapant in combination with Keytruda for solid tumors, currently in phase I, MIV-818, a nucleotide prodrug drug for liver cancer that recently entered into a phase I clinical trial, and MIV-711, a potentially disease-modifying osteoarthritis candidate drug with fresh and promising data from the recent phase IIa extension study. Medivir is listed on the Nasdaq Stockholm Mid Cap List (ticker: MVIR). www.medivir.com.

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