STRONG DEVELOPMENT ACROSS THE PORTFOLIO
October – December
Significant events during the quarter
- Medivir received FDA Fast Track Designation for MIV-711 for the treatment of osteoarthritis (OA).
- Remetinostat phase II data demonstrated efficacy on skin lesions, reduction of itching and high tolerability in patients with early-stage cutaneous T-cell lymphoma (CTCL).
- A new cancer project entered lead optimization. The new project Leukotide, is aimed at an improved treatment for acute myeloid leukemia (AML) and other hematological malignancies, and is derived from Medivir’s in-house nucleotide platform.
- Janssen decided to terminate its simeprevir license effective June 2018.
- Erik Björk appointed as Chief Financial Officer and Christina Herder appointed as Executive Vice President Strategic Business Development.
- Net turnover for the continuing operations totaled SEK 4.2 million (9.9 m), SEK 4.2 million (7.1 m) of which comprised the fourth quarter’s royalties. Other operating income totaled SEK 2.4 million (2.4 m).
- The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -92.6 million (-125.8 m). Basic and diluted earnings per share were SEK -5.08 (-4.50) and -5.08 (-4.50) respectively.
- The cash flow from operating activities amounted to SEK -88.9 million (-71.8).
- Non-recurring costs of SEK -9.4 million (-49.1 m) affected the result during the quarter.
- Liquid assets and short-term investments totaled SEK 467.8 million (1 698.5 m) at the period end.
January – December
- Net turnover for the continuing operations totaled SEK 36.6 million (93.0 m), where of SEK 32.7 million (64.0 m) comprised royalties for the year. Other operating income totaled SEK 9.9 million (12.7 m).
- The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -342.6 million (-300.6 m). Basic and diluted earnings per share were SEK -16.40 (-10.94) and -16.40 (-10.94) respectively.
- The cash flow from operating activities amounted to SEK -358.5 million (-182.3).
- Non-recurring costs of SEK -20.6 million (-52.6 m) affected the result during the year.
- Liquid assets and short-term investments totaled SEK 467.8 million (1 698.5 m) at the year end.
Significant events after the year end
- The Board was seeking issue authorizations to increase the company’s funding flexibility and called for an EGM.
- The EGM resolved to authorize the board to resolve to issue new shares with deviation from the shareholders’ pre-emptive rights of a total not more than 20 percent and to resolve to issue new shares with pre-emptive rights for the company’s shareholders.
- Medivir has completed a directed share issue of approximately SEK 155 million before transaction related expenses.
- Successful completion of pre-clinical safety studies with MIV-818, enabling start of phase I clinical studies in 2018.
- The holders of series A shares have notified the Company that they will convert all their series A shares to series B shares.
Conference call for investors, analysts and the media
The Year End report 2017 will be presented by Medivir’s President & CEO, Christine Lind.
Time: Wednesday, 14 February 2018, at 15.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 566 426 96
Europe + 44 20 3008 9804
US + 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.
For further information, please contact:
Christine Lind, President & CEO, +46 (0) 8 5468 3100 or, Erik Björk, CFO, +46 (0) 72 228 2831.
In 2016, we carried out a comprehensive transformation of Medivir to create a new, focused and efficient pharma company with a strong pipeline.
In 2017, we continued this development, with a clear focus on our prioritized projects and the aim to improve life for patients through transformative drugs. With our balanced pipeline – including both potential blockbusters and orphan drugs – and strong discovery engine, I passionately believe that we are moving in the right direction. Since I took on the role as the CEO of the company, on April 1, we have made a number of important advances, both scientifically and as a company.
The ground-breaking top-line results from our initial phase IIa study in the MIV-711 osteoarthritis project were released in September, and full data were presented as a late breaking presentation at the Annual Meeting of the American College for Rheumatology in November. This was the first time ever that a therapeutic agent has demonstrated clinical benefits on both joint bone and cartilage in osteoarthritis patients in only six months. The fact that the US Food and Drug Administration (FDA) also granted MIV-711 fast track designation in October confirms its importance. MIV-711 has the potential to be the first disease-modifying drug for the treatment of osteoarthritis.
Within our key focus area – oncology – we also made good progress during the year. For remetinostat, the phase II data we presented in October strongly support advancement of this drug into pivotal clinical trials and discussions with regulatory authorities on the design of the phase III study are underway.
In August, we launched a phase I/II study of birinapant in combination with Merck´s Keytruda®, to investigate clinical efficacy of the combination of birinapant with the leading immune checkpoint inhibitor in patients with advanced solid tumors.
MIV-818, Medivir’s proprietary nucleotide prodrug aimed at liver cancers, entered preclinical development in late 2016 and the program was extensively presented at major international conferences in 2017. In early January 2018, we announced the completion of preclinical studies that we plan to make the necessary regulatory submissions in order to start the first clinical trials of MIV-818 during the second half of 2018.
In November, we announced a new discovery project within oncology, demonstrating our confirmed ability to bring new projects for cancer from our research efforts. The Leukotide project is intended to deliver a new drug for the treatment of acute myeloid leukemia (AML) and other hematological malignancies. The project is based on our expertise in nucleoside and nucleotide science.
Medivir has established itself as a partner of choice in the pharma industry; over the years, we have signed more than 20 successful partnerships, including two in 2017. We continue to be effective in out-licensing programs from our scientific areas of expertise even in early stages. In August, we signed an agreement granting Ascletis exclusive rights to develop, manufacture and commercialize MIV-802, for the treatment of hepatitis C, in Greater China.
In October, we announced an agreement with the AMR Centre in the UK which will see them take over the development of molecules to counter bacterial resistance to b-lactam antibiotics. This project arose from our research work on metallo-b-lactamases, which are proteases. I believe that our partners in both these cases are well positioned to lead the continued successful development of these projects.
Important company milestones
We made some important recruitments to further strengthen the company, and in the autumn, we recruited Erik Björk as Chief Financial Officer, and Christina Herder as Executive Vice President, Strategic Business Development. They will make outstanding additions to our management team.
In February 2018, Medivir has completed a directed share issue of approximately SEK 155 million before transaction related expenses to life sciences specialist investors.
The many achievements we made during 2017 make me very confident in Medivir’s future. We are well-positioned to continue our journey towards becoming a research pharmaceutical company that brings important, transformative products to the market. We can do it from a stronger financial position and with an excellent, experienced and well-motivated organization.
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 12.00 CET on 14 February 2018.