Press release as PDF

MEDIVIR AB – INTERIM REPORT, SECOND QUARTER 2015

Financial summary
Second quarter 2015 (2014)

  • Net turnover totalled SEK 245.8 million (564.0 m), of which SEK 165.6 million (500.7 m) comprised second quarter royalties for simeprevir.
  • Revenues from Medivir’s own pharmaceutical sales totalled SEK 55.1 million (62.9 m), of which SEK 13.2 million (21.7 m) derived from sales of OLYSIO® and SEK 41.9 million (41.2 m) from sales of other pharmaceuticals.
  • The profit after tax was SEK 64.1 million (327.8 m).
  • Basic and diluted earnings per share totalled SEK 2.21 (10.49) and SEK 2.19 (10.28), respectively.
  • The cash flow from operating activities amounted to SEK 64.3 million (88.7 m).

Six months 2015 (2014)

  • Net turnover totalled SEK 461.7 million (772.2 m), of which SEK 294.2 million (662.4 m) comprised the first six months royalties for simeprevir.
  • Revenues from Medivir’s own pharmaceutical sales totalled SEK 141.9 million (109.2 m), of which SEK 47.4 million (21.7 m) derived from sales of OLYSIO® and SEK 94.5 million (87.5 m) from sales of other pharmaceuticals.
  • The profit after tax was SEK 130.7 million (611.7 m).
  • Basic and diluted earnings per share totalled SEK 4.50 (19.57) and SEK 4.46 (19.18), respectively.
  • The cash flow from operating activities amounted to SEK 269.6 million (31.0 m).

Summary of the Group’s figures, continuing operations (SEK m) Q2 Q1-Q2 Full year
2015 2014 2015 2014 2014
Net turnover 245.8 564.0 461.7 772.2 1 767.0
Gross profit 214.9 518.8 397.7 700.9 1 593.0
Operating profit before depreciation and amort. (EBITDA) 104.9 424.4 189.6 521.2 1 221.9
Operating profit (EBIT) 96.1 416.2 172.2 504.9 1 188.7
Profit/loss before tax 85.4 418.4 168.2 508.7 1 192.7
Profit/loss after tax 64.1 327.8 130.7 611.7 1 132.7
Operating margin, % 39.1 73.8 37.3 70.0 67.3
Basic earnings per share, SEK 2.21 10.49 4.50 19.57 36.24
Diluted earnings per share, SEK 2.19 10.28 4.46 19.18 35.90
Net worth per share, SEK 55.7 46.9 55.7 46.9 63.4
Return on equity 5.8 32.2 9.7 43.9 84.1
Cash flow from operating activities 64.3 88.7 269.6 31.0 1 014.4
Liquid assets and short-term investments at period end 1 043.4 430.4 1 043.4 430.4 1 395.6
R&D spending/total opex, % 60.2 62.8 61.1 59.4 60.8


Conference call for investors, analysts and the media
The Interim Report for the second quarter of 2015 will be presented by Medivir’s President & CEO,
Niklas Prager, and members of Medivir’s management group.

Time: Thursday, 20 August 2015, at 14.00 (CET).

Phone numbers for participants from:
Sweden +46 (0)8 566 426 62
Europe +44 20 342 814 09
USA +1 855 831 5945

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

CEO’s comments
Q2 saw us continuing to both build our research portfolio’s value and to increase our focus on the core areas of infectious diseases and oncology.

We strengthened the oncology component of our research portfolio by initiating a partnership with Cancer Research Technology (CRT) and The University of Marburg to develop a new class of drugs to treat cancer. The collaboration aims to develop molecules that target the ADAM8 protein, which is linked to tumour survival, cell invasion and metastasis. CRT has an excellent reputation in the international cancer research community and the partnership not only demonstrates the strength of Medivir’s technology platform, but also validates its potential in the field of cancer research.

The progress being made by our in-house oncology projects was evidenced by the announcement to progress the development of the HCC project for the treatment of hepatocellular carcinoma with already identified promising lead molecules. The aim is to develop specifically liver targeted nucleotide prodrugs using our expertise in nucleotide and nucleoside science.

Medivir elected to end its development of the MIV-247 cathepsin S inhibitor after the preclinical safety studies produced unfavourable findings, and which constituted a further step in focusing on our core areas. This decision marked our withdrawal from research into neuropathic pain.

The preparations for a clinical phase II trial with MIV-711 in osteoarthritis by the year-end are proceeding according to plan with ongoing preclinical regulatory safety studies.

Partnership discussions are continuing with a number of potential partners with regard to our internal hepatitis C project, MIV-802.

After the quarter end, we announced that our outlicensed projects partnered with Janssen have also made progress: The AL-704 HCV nucleotide, also known as JNJ-54257099, entered clinical phase I development in early July. In addition, a phase I trial with a triple combination product, where the primary objective is to investigate the effect of the combination of simeprevir and odalasvir on the pharmacokinetics of AL-335 (a nucleotide-based HCV polymerase inhibitor) was initiated.

We conducted a reorganisation of our research operations as part of our ongoing work with operational optimisation, and entered into a partnership with GVK BIO, as part of this change. All of our external synthetic chemistry activities will now be concentrated within a single research unit at GVK, and the addition there of a further 20 or so research staff will enable us to accelerate our synthesis work. The aim is to enhance the efficiency and improve the quality of our research projects, but also, in the longer term, to cut research costs and increase flexibility. These changes meant that around 10 employees at Medivir’s research units in Sweden and the UK were made redundant.

Royalty income attributable to the hepatitis C drug, OLYSIO® (simeprevir) totalled SEK 166 million in the second quarter. Increased competition resulted in a fall in global net sales of OLYSIO® in comparison with the corresponding quarter of the previous year.

Our Nordic pharmaceutical sales organisation with its two arms, Innovative Specialty Care and Nordic Brands, posted combined sales of SEK 55 million during the quarter. Sales of OLYSIO® accounted for SEK 13 million of this total, while Nordic Brands posted a year-on-year increase in sales of 1 per cent. OLYSIO® has established a niche position in the Nordic region, with the drug primarily prescribed for those patients who have proved most difficult to treat.

Overall, the second quarter has delivered progress in both our partnered projects and our in-house projects at the same time as we broadened our pipeline through external partnerships. This is all according to plan and I am convinced that the ongoing progress of our projects will ensure that we continue to build long-term value within Medivir.

Niklas Prager
President and CEO


Upcoming reporting dates:
Interim Report Q3 (January–September)
20 November 2015
Full year report 2015
18 February 2016

For further information, please contact:
Niklas Prager, President & CEO, phone: +46 (0) 8 407 64 30
Ola Burmark, CFO, mobile: +46 (0)725-480 580.

Medivir is required under the Securities Markets Act to make the information in this press release public.
The information was submitted for publication at 08.30 CET on 20 August 2015.

About Medivir
Medivir is a research based pharmaceutical company with a research focus on infectious diseases and oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a growing portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

Page updated 10 november 2014