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Two new projects into clinic

October – December
Significant events during the quarter

  • The first patient was dosed in the phase II study with birinapant and Keytruda® as combination therapy in colorectal cancer.
  • The first patient with advanced cancer in the liver was dosed with the company's drug candidate MIV-818 in a phase Ia study.
  • MIV-828 was selected as a candidate drug for the treatment of acute myeloid leukemia (AML) and other forms of blood cancer.
  • Dr Uli Hacksell was appointed new CEO of Medivir.
  • A reorganization, with the aim of focusing the internal resources on the company's clinical development projects, was carried out. The organization was reduced from 75 to a total of 17 employees.
  • In the quarter Medivir has recorded SEK 38.1 million as restructuring costs.

Financial summary

  • Net turnover totaled SEK 13.6 million (4.2 m).
  • The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -96.6 million (-92.6 m). Basic and diluted earnings per share were SEK -4.72 (-5.08) and -4.72 (-5.08) respectively.
  • The cash flow from operating activities amounted to SEK -72.4 million (-88.9 m).

January - December
Financial summary

  • Net turnover totaled SEK 23.9 million (36.6 m).
  • The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -326.5 million (-342.6 m). Basic and diluted earnings per share were SEK -14.62 (-16.40) and -14.62 ( -16.40) respectively.
  • The cash flow from operating activities amounted to SEK -320.5 million (-358.5 m).
  • Liquid assets and short-term investments totaled SEK 286,3 million (467.8 m) at the period end.

Significant events after the period end

  • CFO Erik Björk has decided to leave the company but will remain during a transition period. Process to recruit a new CFO has been initiated.

Conference call for investors, analysts and the media
The Year End report 2018 will be presented by Medivir’s President & CEO, Uli Hacksell.

Time: Thursday, February 14, 2019, at 15.00 (CET).

Phone numbers for participants from:
Sweden + 46 8 505 583 55
Europe + 44 33 3300 9030
US + 1 646 722 4957

The conference call will also be streamed via a link on the website:
The presentation will be available on Medivir’s website after completion of the conference.

For further information, please contact
Uli Hacksell, CEO, +46 (0) 8 5468 3100
Erik Björk, CFO, +46 (0)72-228 2831 

CEO’s comments

Medivir's reorganization is now complete. We have entered 2019 with a slimmed organization that has a clear focus on the exciting clinical projects.

An important event in 2018 was the reorganization that was presented in connection with me becoming CEO on October 15. To ensure that our resources are used where we can create the greatest value, we have concentrated our operations on clinical development. Fundamentally, the measures are based on the positive development of our clinical projects.

Through the redundancies, primarily within research and administration, the organization has been reduced from 75 to a total of 17 employees. The measures will free up resources for Medivir's clinical development projects as they are expected to reduce our cost base by about two thirds.

The most important task for Medivir is to develop and realize the value of our clinical development portfolio, which consists of four programs.

Remetinostat is Medivir's topical HDAC inhibitor being developed for the treatment of mycosis fungoides, the most common form of cutaneous T-cell lymphoma, (MF-CTCL), a form of blood cancer that is primarily manifested in the skin. At the end of the year, we had clarifying and positive discussions with the FDA regarding the design of the phase III program for MF-CTCL. One successful phase III study is expected to be sufficient to enable a marketing approval for the treatment of patients with early stage MF-CTCL. At the same time, there are strict requirements regarding the design of such a study. Medivir is now further developing the phase III design based on the clarifications from the FDA. We intend to seek a partner for the continued development and commercialization of remetinostat.

In our collaboration with Stanford University School of Medicine in California, the first patient was dosed with remetinostat in their investigator-initiated phase II study on patients with basal cell cancer in early August.

Birinapant is a SMAC mimetic that is being studied for treatment in combination with MSD's anti-PD-1 treatment Keytruda® (pembrolizumab) in patients with solid tumors. In October, an interim analysis of the phase I study comprising the first 12 patients in the study was presented. The analysis showed a positive safety profile and, in addition, an interesting efficacy signal was noted, since one of the patients with microsatellite-stable (MSS) colorectal cancer, a cancer form in which treatment with Keytruda® alone rarely produces effect, achieved a confirmed partial response (according to RECIST 1.1) which remained at the last evaluation. The patient remains on treatment more than one year after the start of therapy. Three additional patients have had periods of stable disease lasting up to 18 weeks after the start of treatment.

The inclusion of the first colorectal cancer patient in the phase II part of the study took place just before Christmas.

MIV-818 is Medivir's nucleotide prodrug that is being developed for the treatment of liver cancer. In an ongoing phase I study, four patients have been included. The purpose of this first-in-human study is to study safety, tolerability and pharmacokinetics of MIV-818 in patients with advanced cancer in the liver, a fatal disease with very few available treatment options.

At the end of November, we were able to announce an exciting addition to the development portfolio as MIV-828 was chosen as a candidate drug for the treatment of acute myeloid leukemia (AML) and other forms of blood cancer.

At the end of the second quarter, we were able to present an acceptable safety and tolerability profile in our phase II extension study with MIV-711, Medivir's cathepsin K inhibitor for the treatment of osteoarthritis. Top-line results, presented at the end of July, showed that treatment with MIV-711 for a total of 12 months resulted in a continuing treatment effect on joint bone area growth and prevention of cartilage degradation. In August, the FDA published new preliminary guidance for the development of disease-modifying treatments for osteoarthritis. The FDA modified its previous approach to structural end-points and the new guidance discuss structural impact as treatment goals in clinical studies and how it could potentially be used for so-called "accelerated approval". Medivir continues to aim to establish a license or collaboration agreement for MIV-711.

The clinical projects have successfully moved forward. This shows that Medivir's research and development has consistently been of high quality. However, to ensure our ability to continue to develop and benefit from the potential that lies in our clinical portfolio, we chose to concentrate our operations and took measures that entailed announcing redundancies and reducing Medivir’s preclinical research. Once again, I would like to thank our employees leaving the company for their valuable contribution to Medivir. They have worked loyally, diligently and professionally for Medivir, many for numerous years. We wish those who leave Medivir success in their future pursuits.

Medivir has now been turned into a organization with good ability to work virtually and with high flexibility. We have experience of both drug development and business development.

Medivir's increased focus on clinical development gives us a positive view of the future. I look forward to an exciting 2019.

Uli Hacksell
President and CEO

The information was submitted for publication at 08.30 CET on 14 February 2019.