Financial summary
Fourth quarter 2015 (2014)
- Net turnover totalled SEK 84.7 million (377.0 m), SEK 31.1 million (220.1 m) of which comprised royalties for simeprevir.
- Revenues from Medivir’s own pharmaceutical sales totalled SEK 53.1 million (156.6 m), of which SEK 2.7 million (103.1 m) derived from sales of OLYSIO® and SEK 50.4 million (53.5 m) from sales of other pharmaceuticals.
- The loss after tax was SEK -45.2 million (147.3 m).
- Basic and diluted earnings per share totalled SEK -1.56 (4.71) and SEK -1.54 (4.67), respectively.
- The cash flow from operating activities amounted to SEK -37.6 million (507.9 m).
Twelve months 2015 (2014)
- Net turnover totalled SEK 657.9 million (1,767.0 m), SEK 418.6 million (1,399.0 m) of which comprised full year royalties for simeprevir.
- Revenues from Medivir’s own pharmaceutical sales totalled SEK 237.5 million (366.8 m), of which SEK 53.0 million (186.4 m) derived from sales of OLYSIO® and SEK 184.5 million (180.4 m) from sales of other pharmaceuticals.
- The profit after tax was SEK 75.1 million (1,132.7 m).
- Basic and diluted earnings per share totalled SEK 2.59 (36.24) and SEK 2.56 (35.9), respectively.
- The cash flow from operating activities amounted to SEK 307.4 million (1.011.9 m).
| Summary of the Group’s figures, continuing operations (SEK m) | Q4 | Q1-Q4 | ||
| 2015 | 2014 | 2015 | 2014 | |
| Net turnover | 84.7 | 377.0 | 657.9 | 1 767.0 |
| Gross profit | 60.7 | 324.5 | 548.6 | 1 593.0 |
| Operating profit before depreciation and amortisation (EBITDA) | -35.9 | 214.9 | 155.0 | 1 221.9 |
| Operating profit (EBIT) | -44.5 | 206.5 | 114.8 | 1 188.7 |
| Profit/loss before tax | -53.1 | 204.3 | 102.0 | 1 192.7 |
| Profit/loss after tax | -45.2 | 147.3 | 75.1 | 1 132.7 |
| Operating margin, % | -52.5 | 54.8 | 17.4 | 67.3 |
| Basic earnings per share, SEK | -1.56 | 4.71 | 2.59 | 36.24 |
| Diluted earnings per share, SEK | -1.54 | 4.67 | 2.56 | 35.90 |
| Net worth per share, SEK | 53.8 | 63.4 | 53.8 | 63.4 |
| Return on equity | -3.6 | 10.7 | 5.9 | 84.1 |
| Cash flow from operating activities | -37.6 | 507.9 | 307.4 | 1 011.9 |
| Liquid assets and short-term investments at the period end | 1 077.9 | 1 395.6 | 1 077.9 | 1 395.6 |
| R&D spending/total opex, % | 66.9 | 64.7 | 64.2 | 60.8 |
Conference call for investors, analysts and the media
The 2015 Financial Statement will be presented by Medivir’s President & CEO, Niklas Prager and members of Medivir’s management group.
Time: Thursday, 18 February 2016, at 14.00 (CET).
Phone numbers for participants from:
Sweden +46 8 566 426 90
Europe +44 20 3008 9801
USA +1 855 753 2236
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
2015 saw Medivir continue both to make important progress in our projects and to build the value of our research and development portfolio, which is based on Medivir’s established and proven technology platform.
One example of this progress was the completion, on schedule, of the preclinical safety studies relating to our osteoarthritis project, MIV-711. The first patients were enrolled in the trial early in the New Year and we still anticipate being able to report the results of the trial in Q3 2017, at which time we will hopefully be able to confirm the results achieved to date. The fact that osteoarthritis is so widespread, coupled with the current lack of any pharmaceuticals that impact the progression of the disease, mean that the potential market for any such drug is considerable indeed. We estimate that the US market alone is greater than USD 6 billion annually for a drug that impacts disease progression, even if its use was restricted just to patient populations with moderate osteoarthritis in weight-bearing joints.
Our HCC oncology project for the treatment of hepatocellular carcinoma is also proceeding according to plan and we expect to commence preclinical safety studies as part of this project in the fourth quarter of 2016.
The preclinical safety studies as part of the MIV-802 project for the treatment of hepatitis C were completed according to plan at the end of the year and will now form the basis for continued discussions with potential partners.
Janssen – our partner for simeprevir – launched a clinical phase IIa trial of a simeprevir-based triple combination treatment for chronic hepatitis C infection at the beginning of Q4. The results are expected during the latter half of 2016 and will be important in terms of the potential for a subsequent launch of a competitive combination treatment. Janssen also announced in Q4 that it had discontinued the development of the AL-704 polymerase inhibitor for the treatment of hepatitis C, as the results failed to justify further clinical trials.
Q4 and full year royalties attributable to the hepatitis C drug, OLYSIO® (simeprevir), totalled SEK 31 million and SEK 419 million, respectively, corresponding to a decline in comparison with the corresponding periods in 2014 due to the increased competition OLYSIO® faced in 2015.
Our Nordic pharmaceutical sales organisation, comprising Innovative Specialty Care and Nordic Brands, achieved combined sales of SEK 237 million in 2015. Nordic Brands’ net sales increased by 2.0 per cent, year on year, and the gross margin also improved following a combination of price increases and cost-cutting measures.
Our development and progress in 2015 has given us a foundation on which to continue building long-term value and I look forward with every confidence to Medivir’s ongoing value creation and the exciting activities that lie ahead for us in 2016.
Niklas Prager
President and CEO
Upcoming reporting dates:
Interim Report (January – March 2016)
28 April 2016
Annual General Meeting 2016
3 May 2016 at 2p.m., in Stockholm, Sweden
Interim Report (January – June 2016)
17 August 2016
Interim Report (January – September 2016)
10 November 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 18 February 2016.
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 portfolio of specialty care pharmaceuticals on the Nordic market.
Medivir is listed on the Nasdaq Stockholm Mid Cap List.