Financial summary
Third quarter 2015 (2014)
- Net turnover totalled SEK 111.5 million (617.8 m), of which SEK 69.0 million (516.4 m) comprised royalties for simeprevir, where of SEK 11.5 million referred to past periods.
- Revenues from Medivir’s own pharmaceutical sales totalled SEK 42.6 million (100.8 m), of which SEK 2.8 million (61.6 m) derived from sales of OLYSIO® and SEK 39.8 million (39.2 m) from sales of other pharmaceuticals.
- The loss after tax was SEK -10.5 million (373.7 m).
- Basic and diluted earnings per share totalled SEK -0.36 (11.95) and SEK -0.36 (11.83), respectively.
- The cash flow from operating activities amounted to SEK 75.4 million (473.0 m).
Nine months 2015 (2014)
- Net turnover totalled SEK 573.2 million (1,390.0 m), of which SEK 387.5 million (1,178.7 m) comprised the first nine months´ royalties for simeprevir.
- Revenues from Medivir’s own pharmaceutical sales totalled SEK 184.5 million (210.2 m), of which SEK 50.2 million (83.3 m) derived from sales of OLYSIO® and SEK 134.3 million (126.9 m) from sales of other pharmaceuticals.
- The profit after tax was SEK 120.3 million (985.4 m).
- Basic and diluted earnings per share totalled SEK 4.14 (31.52) and SEK 4.11 (31.21), respectively.
- The cash flow from operating activities amounted to SEK 345.0 million (896.4 m).
| Summary of the Group’s figures, continuing operations (SEK m) | Q3 | Q1-Q3 | Full year | ||
| 2015 | 2014 | 2015 | 2014 | 2014 | |
| Net turnover | 111.5 | 617.8 | 573.2 | 1 390.0 | 1 767.0 |
| Gross profit | 90.2 | 567.6 | 487.9 | 1 268.5 | 1 593.0 |
| Operating profit before depreciation and amortisation (EBITDA) | 1.3 | 485.7 | 190.9 | 1 006.9 | 1 221.9 |
| Operating profit (EBIT) | -13.1 | 477.3 | 159.2 | 982.2 | 1 188.7 |
| Profit/loss before tax | -13.3 | 479.6 | 155.0 | 988.3 | 1 192.7 |
| Profit/loss after tax | -10.5 | 373.7 | 120.3 | 985.4 | 1 132.7 |
| Operating margin, % | -11.8 | 77.3 | 27.8 | 70.7 | 67.3 |
| Basic earnings per share, SEK | -0.36 | 11.95 | 4.14 | 31.52 | 36.24 |
| Diluted earnings per share, SEK | -0.36 | 11.83 | 4.11 | 31.21 | 35.90 |
| Net worth per share, SEK | 55.4 | 58.8 | 55.4 | 58.8 | 63.4 |
| Return on equity | -0.9 | 29.0 | 8.9 | 73.4 | 84.1 |
| Cash flow from operating activities | 75.4 | 473.0 | 345.0 | 504.0 | 1 014.4 |
| Liquid assets and short-term investments at the period end | 1 118.1 | 896.4 | 1 118.1 | 896.4 | 1 395.6 |
| R&D spending/total opex, % | 68.1 | 58.6 | 63.3 | 59.2 | 60.8 |
Conference call for investors, analysts and the media
The Interim Report for the third quarter of 2015 will be presented by Medivir’s President & CEO,Niklas Prager and members of Medivir’s management group.
Time: Friday, 20 November 2015, at 14.00 (CET).
Phone numbers for participants from:
Sweden +46 (0)8 566 426 61
Europe +44 20 342 814 10
USA +1 866 388 1925
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
The third quarter saw us continuing to build the value of our research portfolio, based on Medivir’s established and documented successful technology platform.
Our projects’ progress in Q3 included the launch in July by our partner, Janssen, of a phase I clinical trial of AL-704, a nucleotide-based NS5B polymerase inhibitor from Medivir for the treatment of chronic hepatitis C infection in combination with other direct-acting antivirals.
The quarter also marked the launch by Janssen of a phase I clinical trial to evaluate the potential effect of simeprevir and odalasvir on AL-335 pharmacokinetics in healthy volunteers.
We were also able to announce, after the quarter end, that Janssen has started a phase IIa clinical trial to evaluate the effect of a triple combination treatment regimen comprising simeprevir, odalasvir and AL-335 in treatment-naïve patients with genotype 1 chronic hepatitis C virus infection.
The preclinical safety testing of MIV-711 has been completed and submission of regulatory approval documentation to support this study is underway. Our aim is to start a phase IIa trial at the end of the year.
We are engaged in ongoing discussions with potential partners for some time now with regard to the MIV-802 project for the treatment of hepatitis C, and we are now awaiting the results of the ongoing preclinical safety trials before continuing these discussions.
These successes in our development projects were very pleasing, but one of our early discovery projects unfortunately failed to live up to expectations. Earlier this year, we launched a partnership with Cancer Research Technology (CRT) for the development of a new class of cancer drugs. Based on data generated during the last six months and after internal reviews of the project, we decided to deprioritise and close down the ADAM8 inhibitor project for pancreatic cancer.
In order to continue building long-term value in Medivir as efficiently as possible we have re-sized the commercial organisation during the period, adapting it in line with the declining levels of OLYSIO® sales in the Nordics. We have, accordingly, as of 1st of October, grouped all of our R&D work under the banner of a single, joint unit that will span the entire process, from early discovery to the clinical development phases. I am convinced that not only will this change enhance our ability to prioritise and enhance the efficiency of our research operations; it will also increase our flexibility and ability to broaden the portfolio of projects in clinical development phases. We also, at the same time, created a new function – Strategic Regulatory Affairs – which will house all regulatory skills and areas of responsibility and which is headed by Åsa Holmgren. Åsa has become a member of Medivir’s management group.
Royalties attributable to the hepatitis C drug, OLYSIO® (simeprevir), totalled SEK 57.5 million during the third quarter, signalling that the declining trend in net sales of OLYSIO® is continuing, year on year.
Our Nordic pharmaceutical sales organisation, comprising Innovative Specialty Care and Nordic Brands, posted combined sales of SEK 42.6 million during the third quarter. OLYSIO® contributed SEK 2.8 million to this total and Nordic Brands posted an increase in sales of 1.3 per cent, year on year.
Overall, the quarter has seen the ongoing progress by the majority of our projects enable us to continue building long-term value, despite one set of negative results from our discovery research, and I have every reason to believe that this progress will continue.
Niklas Prager
President and CEO
Upcoming reporting dates:
Full Year Report 2015
18 February 2016
Interim Report (January – March 2016)
28 April 2016
Annual General Meeting 2016
3 May 2016 at 2PM, in Stockholm, Sweden
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 November 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.