MEDIVIR AB – INTERIM REPORT, JANUARY – SEPTEMBER 2017
Positive data reported across multiple clinical programs
July - September
Significant events during the quarter
- Positive topline results from phase IIa osteoarthritis study showed disease-modifying benefit and an acceptable safety and tolerability in this patient population.
- FDA accepted Medivir´s IND application for MIV-711, enabling clinical development in the US.
- The exclusive rights to MIV-802 for Greater China were outlicensed to Ascletis.
- Clinical study of birinapant in combination with KEYTRUDA® (pembrolizumab) in patients with treatment-refractory solid tumours was initiated.
- An agreement was signed with Stanford University to launch an investigator-initiated clinical phase II study evaluating the effect of remetinostat gel on patients with basal cell carcinoma.
- Janssen Sciences Ireland UC decided to discontinue development of JNJ-4178 for hepatitis C.
- Net turnover for the continuing operations totalled SEK 5.1 million (25.7 m), SEK 5.1 million (13.5 m) of which comprised the third quarter’s royalties. Other operating income totalled SEK 3.1 million (2.8 m).
- The loss before interest, tax, depreciation and amortisation (EBITDA) totalled SEK -78.3 million (-53.9 m). Basic and diluted earnings per share were SEK -3.94 (-1.87) and -3.94 (-1.87) respectively.
- The cash flow from operating activities amounted to SEK -63.6 million (-37.0).
- Liquid assets and short-term investments totalled SEK 557.8 million (955.0 m) at the period end.
January - September
- Net turnover for the continuing operations totalled SEK 32.4 million (83.2 m), where of SEK 28.5 million (57.0 m) comprised royalties for the period. Other operating income totalled SEK 7.5 million (10.3 m).
- The loss before interest, tax, depreciation and amortisation (EBITDA) totalled SEK -250.1 million (-174.9 m). Basic and diluted earnings per share were SEK -11.42 (-4.85) and -11.42 (-4.85) respectively.
- The cash flow from operating activities amounted to SEK -269.6 million (-110.5m).
- Non-recurring costs of SEK -11.2 million (-3.2 m) affected the result during the period.
- Liquid assets and short-term investments totalled SEK 557.8 million (955.0) at the period end.
Significant events after the period end
- An agreement was signed providing AMR Centre Ltd the exclusive worldwide rights to our research stage metallo-β-lactamase inhibitor program.
- Remetinostat phase II data demonstrating efficacy on skin lesions, reduction of itching and high tolerability in patients with early-stage MF-type CTCL were announced.
- Medivir has decided to bring forward the publication date for the Financial Statement 2017, from 16 February 2018 to 14 February 2018.
- In order to advance more rapidly the development of our clinical portfolio, Medivir has appointed Carnegie Investment Bank as its lead financial advisor, together with Kempen & Co N.V., to evaluate the company's capital structure and possible funding options.
- FDA Fast Track Designation received for MIV-711 for the treatment of OA and the phase IIa osteoarthritis study data was selected as late breaking abstract at the Annual Meeting of the American College for Rheumatology.
Conference call for investors, analysts and the media
The Interim Report for January – September 2017 will be presented by Medivir’s
President & CEO, Christine Lind.
Time: Thursday, 26 October 2017, at 14.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 566 426 96
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.
For further information, please contact:
Christine Lind, President & CEO, +46 (0) 8 5468 3100 or, Anders Lundin, interim CFO, +46 (0) 73 125 1453.
Strides forward across the portfolio
The projects across our strong and balanced R&D portfolio continued to develop well during the third quarter, including the positive results achieved by two of our clinical programs. In addition, we signed agreements to outlicense two of our preclinical stage projects to realize their market potential and bring new treatments to patients in need.
The ground-breaking top-line results from the initial phase IIa study in the MIV-711 osteoarthritis project were released in September. This was the first time ever that clinical data has demonstrated benefits on both joint bone and cartilage in osteoarthritis patients. The fact that FDA granted fast track designation for MIV-711 and the selection by the American College of Rheumatology to present these results confirms its importance. MIV-711 has the potential to be the first disease-modifying drug for the treatment of osteoarthritis, a disease that affects some 30 million people in the USA alone and an estimated 240 million worldwide.
We expect to report headline data from our ongoing extension study with MIV-711 during the first half of 2018.
An additional important milestone in the MIV-711 project this quarter was the US Food and Drug Administration (FDA) acceptance of our IND application. We can now begin clinical development of MIV-711 in the USA.
These events pave the way for a successful out-licensing, and we have engaged external advisors to help find a suitable partner for the future development of MIV-711.
Within oncology – our key focus area – we also made good progress during the autumn. We announced the full phase II data from the remetinostat study in patients with early-stage cutaneous T-cell lymphoma (CTCL) after the end of the quarter. The data strongly supports advancement of this drug into pivotal clinical trials.
In September, we signed a clinical trial agreement with Stanford University to enable an investigator-initiated clinical phase II study of the effect of remetinostat in patients with basal cell carcinomas. The study is scheduled to begin in early 2018 and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to CTCL.
During the quarter, in collaboration with Merck & Co., we launched a phase I/II study of birinapant in combination with KEYTRUDA®, to demonstrate clinically birinapant’s effect as a combination treatment with immune checkpoint inhibitors for patients with treatment resistant solid tumours.
Medivir continues to be successful in out-licensing programs from our scientific areas of expertise even in early stages. During the quarter, we signed an agreement granting Ascletis exclusive rights to develop, manufacture and commercialise MIV-802, a nucleotide prodrug against hepatitis C, in Greater China.
After the period-end, we also announced that we signed an agreement with the AMR Centre in the UK which will see them take over the development of molecules targeting bacterial resistance from our research work on metallo-beta-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.
Our partner, Janssen Sciences Ireland UC, presented medically promising results from JNJ-4178, a triple combination of simeprevir, odalasvir and AL-335 for the treatment of hepatitis C. Nevertheless, the project’s as commercial potential was deemed insufficient and Janssen decided to discontinue development. Janssen, however, continues to sell simeprevir as a single agent for the treatment for hepatitis C.
Good foundation for further positive results
The progress made during and after the third quarter by both our proprietary and partnered projects, was significant, and the aggregate successes of recent months give me every confidence in Medivir’s future. We are increasingly well-positioned to continue our journey towards becoming a pharmaceutical company that brings important, life-saving products to the market.
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 26 October 2017.