MEDIVIR AB – INTERIM REPORT JANUARY – JUNE 2020
Orphan Drug designation for MIV-818 in the EU and in USA
April – June
Significant events during the quarter
- Following the positive opinion given by the European Medicines Agency (EMA), the European Commission granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
- The Board of Directors appointed Yilmaz Mahshid as the new CEO of Medivir. Yilmaz Mahshid has long and broad experience from qualified roles in the life science sector. He will assume his position on September 14, 2020.
- The U.S. Food and Drug Administration (FDA) granted orphan drug designation to MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC).
Financial summary for the quarter
- Net turnover amounted to SEK 4.0 (3.7) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -12.4 (-12.5) million. Basic and diluted earnings per share amounted to SEK -0.52 (-0.51) and SEK -0.52 (-0.51) respectively.
- Cash flow from operating activities amounted to SEK -23.3 (-35.5) million.
- Liquid assets and short-term investments at the end of the period amounted to SEK 94.9 (191.9) million
January - June
- Net turnover amounted to SEK 11.4 (5.7) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -33.1 (-66.6) million. Basic and diluted earnings per share amounted to SEK -1.49 (-2.81) and SEK -1.49 (-2.81) respectively.
- Cash flow from operating activities amounted to SEK -40.0 (-91.8) million.
- Liquid assets and short-term investments at the end of the period amounted to SEK 94.9 (191.9) million.
Significant events after the end of the quarter
- In July, a research collaboration was initiated with the Drug Discovery and Development Platform (DDD) at SciLifeLab on potential inhibitors of SARS CoV-2. Through the collaboration, DDD will get access to Medivir’s unique proprietary protease-targeted compound library.
Conference call for investors, analysts and the media
The Interim Report January - June 2020 will be presented by Medivir’s President & CEO, Uli Hacksell.
Time: Thursday, August 20, 2020, at 14.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 505 583 53
Europe + 44 33 3300 9034
US + 1 833 526 83 95
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.
During the quarter, our proprietary and wholly owned candidate drug, MIV-818, was granted orphan drug designation in both the EU and the US for the treatment of hepatocellular carcinoma. These are important milestones that can facilitate the path to potential market approvals for MIV-818. Medivir has also recruited a new CEO in the form of Yillmaz Mahshid, who from this autumn will lead the development of the company and our exciting projects.
MIV-818 has potential to be the first liver cancer-targeted, orally administered drug that can help patients with advanced liver cancer. During the quarter MIV-818 was granted orphan drug designation in both the EU and the US for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. The classification provides a number of benefits that can lead to a smoother, faster and less costly path to potential market approval. It also provides the opportunity for market exclusivity, seven years in the US and ten years in the EU after approval.
In Asia, unlike in the western world, HCC is a common disease and therefore drugs against HCC are not given orphan drug status in Asia. As a consequence, the clinical development program for MIV-818 will be different in Asia compared to the United States and the European Union. I envision that going forward we need to work with a partner who can be responsible for the development and sale of MIV-818 in the Asian market in order to maximize the value of MIV-818 also in this region.
In March, positive data from our phase Ia study were presented and shortly thereafter, the first patient with advanced liver cancer was dosed in the current phase Ib study with MIV-818. The study will determine the safety and tolerability profile of MIV-818 but will also further investigate the efficacy of MIV-818. The ongoing Covid-19 pandemic has affected patient recruitment, which has been taken into account. However, we see today no obstacles to present the overall results from the study during the first quarter of 2021.
With our human and financial resources invested in MIV-818, we have not yet been able to begin the preclinical development of MIV-828, the candidate substance that focuses on the treatment of blood cancer.
Regarding our other clinical projects, i.e. remetinostat, birinapant and MIV-711, our focus is on business development. However, I would like to mention that we have two ongoing investigator-initiated studies of remetinostat, in patients with basal cell carcinoma (BCC) and squamous cell carcinoma, respectively, and that preliminary results from the BCC study were very encouraging. In another investigator-initiated study, a combination of birinapant and radiotherapy is being evaluated in patients with recurrence of squamous cell carcinoma in the head and neck region.
At the end of May, we were able to present that Yilmaz Mahshid, with long and broad experience from qualified roles in the life science sector, has been recruited to take over as CEO of Medivir. Yilmaz Mahshid will take over in September and I am convinced that he will be perfect as the new CEO of Medivir. Yilmaz is extremely qualified and has the background, drive and strategic thinking that our exciting company needs. I will remain as CEO until Yilmaz assumes his position. Some time after the handover, I will return to work only as a Board Member.
This is thus my last quarterly report as CEO and I would like to take this opportunity to thank you for the trust, from employees and colleagues as well as from shareholders and the Board, during the almost two years I have had the privilege of leading the company. It has been a journey where we have reshaped Medivir, sharpened the company's focus and implemented radical organizational changes. At the same time, we have seen success, especially in the development of MIV-818, which shows that our proprietary and wholly owned projects have great potential. Medivir of today is a flexible and efficient development company that uses its resources where they can create the greatest value. It will be very exciting to follow the development going forward.
President & CEO
For further information, please contact
Uli Hacksell, CEO, +46 (0) 8 5468 3100
Magnus Christensen, CFO, +46 (0)73-125 0620
This report has not been subject to auditors' review.
The information was submitted for publication at 08.30 CET on 20 August 2020.