January – March
Financial summary for the quarter
- Net turnover amounted to SEK 9.9 (7.3) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -7.2 (-20.7) million. Basic and diluted earnings per share amounted to SEK -0.18 (-0.96) and SEK -0.18 (-0.96) respectively.
- Cash flow from operating activities amounted to SEK -1.5 (-16.6) million.
- Liquid assets and short-term investments at the end of the period amounted to SEK 269.3 (116.6) million.
Significant events during the quarter
- In January the company signed an exclusive license agreement with IGM Biosciences, Inc. for birinapant. Medivir received a payment of USD 1 million after signing, which is to be followed by an additional USD 1.5 million when IGM includes birinapant in phase I clinical trials. In addition, the agreement entitles Medivir to milestone payments and royalties.
- A rights issue of class B shares with preferential rights for existing shareholders was completed in early February. Through the rights issue, which was oversubscribed to 93.5 percent, Medivir received approximately SEK 170 million before transaction costs.
- The Board of Directors decided to exercise the over-allotment option of SEK 25 million, directed to the specialist investor HealthInvest.
- An Extraordinary General Meeting on March 11, 2021, decided on a directed new share issue of approximately SEK 28 million to Linc AB.
- In February 2021 a licensing agreement with Ubiquigent was signed for the preclinical research program USP7.
- In March, the last patient was included in the first part of the phase Ib study with MIV-818.
- In March 2021, it was announced that Yilmaz Mahshid will leave his position as CEO of Medivir at the Annual General Meeting on May 5, for personal reasons. The recruitment process for a new CEO has begun.
- Medivir’s Nomination Committee proposes the re-election of Uli Hacksell, Lennart Hansson, An van Es Johansson and Bengt Westermark as board members. The Nomination Committee proposes the election of Yilmaz Mahshid as new board member and that Uli Hacksell is elected Chairman of the Board.
Bengt Julander and Helena Levander have declined re-election.
Significant events after the end of the quarter
- On April 16, it was announced that Magnus Christensen had been appointed interim CEO of Medivir. He will take up his new role in connection with Medivir’s Annual General Meeting on May 5, 2021.
- On April 19, it was announced that the overall results from the first part of the phase Ib study with MIV-818 were positive with a good safety and tolerability profile. Thus, the starting dose for the second part of the phase Ib study could be determined.
Conference call for investors, analysts and the media
The Interim Report January - March 2021 will be presented by Medivir’s President & CEO, Yilmaz Mahshid.
Time: Wednesday, April 28, 2021, at 14.00 (CET).
Phone numbers for participants from:
Sweden + 46 8 505 583 52
Europe + 44 33 3300 9260
US + 1 833 526 8398
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.
An important step forward in the clinical development of MIV-818. Out-licensing of birinapant to IGM Biosciences. Successful financing and a strengthened institutional ownership base. The beginning of 2021 has certainly been eventful for Medivir.
The quarter began with the signing of an exclusive license agreement with US based IGM Biosciences for birinapant, for the treatment of solid tumors. The license agreement gives IGM the global and exclusive rights to develop birinapant. IGM intends to initiate clinical studies with birinapant in 2021 in combination with its proprietary antibody IGM-8444, which preclinically has shown enhanced antitumor activity.
The agreement provided Medivir with a payment of USD 1 million after signing, which is to be followed by an additional USD 1.5 million when IGM includes birinapant in phase I clinical trials. Furthermore, the agreement entitles Medivir to milestone payments up to a total of approximately USD 350 million, given that birinapant is successfully developed and approved, and tiered royalties up to mid-teens on net sales. A portion of all revenue is shared with Tetralogic Pharmaceuticals Corporation, from which birinapant was acquired in 2016, but the main part remains with Medivir.
In the financing we successfully carried out in the beginning of 2021, the rights issue was oversubscribed to 93.5 percent. As a result, the over-allotment option was exercised, directed to the specialist investor HealthInvest, which thus becomes a new shareholder in Medivir. In addition, a directed new share issue of approximately SEK 28 million to Linc AB was carried out. In total, Medivir received approximately SEK 223 million before transaction costs through the issues, a financing that is central for us to be able to develop our cutting-edge project MIV-818 into the next phase. That this financing received strong support from both existing owners such as Linc AB and Nordea as well as from new institutional specialist investors such as HealthInvest feels very gratifying. Medivir gained an ownership base with strong institutions in the lead.
Another licensing agreement was signed in February 2021, for Medivir's preclinical research program USP7. The agreement grants UK based Ubiquigent Limited an exclusive global license to develop and commercialize all of the program's related substances in all therapeutic indications in exchange for agreed revenue sharing with Medivir upon successful development or commercialization.
End of March, we could announce that the last patient with advanced liver cancer had been included in the first part of the phase Ib study with Medivir’s leading candidate drug, MIV-818, against liver cancer. Barely a month later, after the end of the quarter, we were able to ascertain that the overall results from this part of the phase Ib study were positive with a good safety and tolerability profile. Thus, we were also able to determine the starting dose for the second part of the phase Ib study. We expect to be able to present detailed data from the first part of the phase Ib study at an upcoming scientific conference. The second part of the phase Ib study, where MIV-818 will be administered in combination with other therapies, is planned to be initiated during the second half of this year.
MIV-818 has potential to become a liver-directed, orally administered drug that can help patients with various cancers in the liver. Liver cancer is the third most common cause of cancer-related deaths in the world and hepatocellular carcinoma (HCC) is the most common form of cancer that occurs in the liver. Although existing treatments for HCC can prolong patients' lives, the treatment benefits are often limited and mortality remains at a high level. The results we have presented so far regarding MIV-818 have generated strong interest.
Despite the ongoing vaccination program, the Covid-19 pandemic is still an uncertainty factor in terms of clinical trial schedules, but we have so far managed to carry out our studies without too serious delays and at present it seems that we will be able to initiate the next part of the phase Ib study as planned during the second half of 2021.
In connection with the Annual General Meeting, I will leave the operational work as CEO of Medivir. I am pleased to be proposed as a board member of Medivir and look forward to continue to contribute to the company's development in that role. The Board's work to recruit my replacement as CEO is in full swing, but not yet fully completed.
I would like to thank my competent and dedicated colleagues at the company for this exciting and inspiring period and assure my successor that Medivir has good prerequisites and a very strong potential to create value for healthcare and patients as well as for our shareholders.
President & CEO
For further information, please contact
Yilmaz Mahshid, CEO, +46 (0) 8 5468 3100
Magnus Christensen, CFO, +46 (0)8 5468 3100
This report has not been subject to auditors' review.
The information was submitted for publication at 08.30 CET on 28 April 2021