HUDDINGE, Sweden, April 28, 2017 Significant events during the first quarter
- The osteoarthritis trial evaluating MIV-711 received the go-ahead to continue without any modifications after a positive fourth review of safety data.
- Christine Lind has been appointed as the new CEO of Medivir, effective as of 1 April 2017.
- Medivir's Extraordinary General Meeting, held in February, resolved on a voluntary redemption programme comprising a reduction in the share capital for repayment to the shareholders. Total cash proceeds of approximately SEK 857.5 million were distributed.
- An agreement was reached with Janssen concerning the out-licensing of the commercial rights to simeprevir and any products containing simeprevir in the Nordic region. In exchange, Medivir will receive royalties on all sales in the Nordic region of products containing simeprevir. The agreement also entitles Medivir to additional milestone payments with a combined value of approximately EUR 6 million. Medivir has, furthermore, returned the commercial rights to Adasuve in the Nordic region to Ferrer.
- Net turnover for the continuing operations totalled SEK 17.8 million (20.6 m), SEK 13.7 million (18.1 m) of which comprised the first quarter's royalties for simeprevir. Other operating income totalled SEK 2.4 million (4.8 m).
- The loss before interest, tax, depreciation and amortisation (EBITDA) totalled SEK -80.9 million (-60.7 m). Basic and diluted earnings per share were SEK -3.59 (-1.50).
- The cash flow from operating activities amounted to SEK -123.9 million (-36.4 m).
- Non-recurring personnel costs of SEK 10.0 million (0.0 m) affected the result during the quarter.
- Liquid assets and short-term investments totalled SEK 708.9 million (1,039.5 m) at the period end.
Significant events after the period end
- Positive data from the phase II clinical study of remetinostat in patients with cutaneous T-cell lymphoma were announced in April.
- Data from an ongoing phase II study with the triple combination of simeprevir, odalasvir and AL-335, was presented at The International Liver Congress™ in April.
Conference call for investors, analysts and the media
The Interim Report for January – March 2017 will be presented by Medivir's President & CEO, Christine Lind.
Time: Friday, 28 April 2017, at 14.00 (CET).
Phone numbers for participants from:
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.
For further information, please contact:
The transformation of Medivir
Medivir's research activities are now focused on oncology and projects in other areas will consequently be out-licensed. This out-licensing work will initially relate to the rights to develop and commercialise the MIV-802 hepatitis C project in China, Taiwan, Hong Kong, and Macau – an area that was excluded from the licensing agreement concluded with Trek Therapeutics in 2016. We are also working to out-license MIV-323 for the treatment of RSV infections, which we believe has the potential to be best-in class, but in which Medivir is no longer investing itself.
The final stage in Medivir's transformation process to becoming a company focused on research and development were completed during the first quarter of the year. An agreement was concluded with Janssen, out-licensing the commercial rights in the Nordic region to simeprevir and potential future products containing simeprevir. Medivir consequently no longer conducts commercialization activities for pharmaceutical products and is now fully focused on research and development activities.
The voluntary redemption programme in connection with the divestment of BioPhausia was also completed during the quarter, resulting in the transfer of SEK 857.5 million to the shareholders. Medivir's management bought shares and sold redemption rights from the redemption programme resulting in an increase in the management group's combined shareholding in Medivir.
Further progress for projects
All of our projects continued to develop according to plan during the quarter. The MIV-711 osteoarthritis trial had its fourth and final expected Data Monitoring Committee review of safety data. All four of the independent Data Monitoring Committee's reviews have yielded the best possible outcome, namely that the ongoing phase IIa trial should continue without any modifications. We expect, as previously stated, to present the data from MIV-711 in the third quarter of 2017.
Our research and development activities are now primarily focused on oncology, including the two very interesting projects in this area that were acquired in 2016: remetinostat and birinapant. We reported topline data from the phase II study of remetinostat in CTCL (cutaneous T-cell lymphoma) after the end of the reporting period. The data from the study was positive and we expect to request a meeting with the US FDA in order to enable a phase III study start in the latter half of 2017. We are also looking forward to starting phase I/II studies of birinapant in partnership with both Merck and the University of California (UCLA) in various cancers.
Royalties attributable to the approved hepatitis C drug, OLYSIO® (simeprevir) amounted to SEK 13.7 million during the first quarter, due to the decline in global net sales of OLYSIO®. Our partner, Janssen, continues to develop simeprevir in a fixed-dose combination with other direct-acting antivirals for hepatitis C and data from the ongoing phase II program are expected to be presented by our partner at upcoming conferences.
A strong, balanced R&D portfolio
I am delighted by the opportunity to lead the implementation of our new, oncology-focused strategy. Medivir has a strong, balanced R&D portfolio with interesting projects in various phases. For a more in-depth description of our strategy and portfolio, I recommend the presentations on our website, www.medivir.com. I also have every confidence in the expertise we have built up within our organisation and in our ability to create long-term value for our shareholders.
President and CEO
This information is information that Medivir AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 08.30 CET on 28 April 2017.
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INTERIM REPORT JANUARY â€" MARCH 2017
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