Medivir AB - Interim Report, January - June 2017

HUDDINGE, Sweden, July 25, 2017 /PRNewswire/ -- April - June

Significant events during the quarter

• Positive data from the phase II study of remetinostat in patients with early-stage cutaneous T-cell lymphoma was presented.
• Enrolment completed in the MIV-711 osteoarthritis extension study and data monitoring committee recommended to "Go Ahead".

Financial summary

• Net turnover for the continuing operations totalled SEK 9.5 million (36.9 m), SEK 7.7 million (24.2 m) of which comprised the second quarter's royalties for simeprevir. Other operating income totalled SEK 1.9 million (2.7 m).
• The loss before interest, tax, depreciation and amortisation (EBITDA) totalled SEK -90.9 million (-60.2 m). Basic and diluted earnings per share were SEK -3.91 (-1.48) and -3.90 (-1.48) respectively.
• The cash flow from operating activities amounted to SEK -82.1 million (-37.1).
• Non-recurring costs of SEK -1.9 million (-2.8 m) affected the result during the quarter.
• Liquid assets and short-term investments totalled SEK 624.2 million (997.5 m) at the period end.

January - June

Financial summary

• Net turnover for the continuing operations totalled SEK 27.3 million (57.5 m), SEK 21.4 million (42.3 m) of which comprised royalties for simeprevir. Other operating income totalled SEK 4.4 million (7.5 m).
• The loss before interest, tax, depreciation and amortisation (EBITDA) totalled SEK -171.8 million (-121.0 m). Basic and diluted earnings per share were SEK -6.57 (-2.98) and -6.56 (-2.98) respectively.
• The cash flow from operating activities amounted to SEK -206.0 million (-73.5 m).
• Non-recurring costs of SEK -12.6 million (-2.7 m) affected the result during the period.
• Liquid assets and short-term investments totalled SEK 624.2 million (997.5) at the period end.  

Conference call for investors, analysts and the media

The Interim Report for January – June 2017 will be presented by Medivir's

Christine Lind
President & CEO

Time: Tuesday, 25 July 2017, at 14.00 (CET).

Phone numbers for participants from:
Sweden 08-566-426-91
Europe +44-20-3008-9804
USA +1-855-753-2235

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
CEO
+46(0)8-5468-3100 

Ola Burmark
CFO
+46(0)725-480-580

CEO's comments Medivir has a strong, balanced R&D portfolio with three exciting projects in clinical development, and a portfolio of cutting edge earlier-stage projects, led by MIV-818. All projects – whether advanced in-house or by our partners – continued to develop according to plan during the quarter.

Proprietary projects

The two projects in our proprietary clinical oncology pipeline, acquired at the end of 2016, have already made strides forward. In early April, we announced positive data from the phase II clinical study of remetinostat in patients with early-stage cutaneous T-cell lymphoma showing a good effect on cancer lesions and an unmatched safety and tolerability profile. With this data, we are planning to initiate discussions with the US regulatory authority (FDA) to enable the start of a phase III study by the end of 2017. We also updated the protocol for the phase I/II combination study of birinapant with Merck's Keytruda™ during the quarter, and expect to initiate the phase I portion of that study in the third quarter.

The MIV-711 osteoarthritis project also developed according to plan, and enrolment was completed in the phase IIa extension study. We also announced the successful outcome of the fifth Data Monitoring Committee review of all available safety data, now including the extension study data so far. We continue to expect to report the headline data from the initial study towards the end of the third quarter 2017 and from the extension study during the first quarter of 2018.

We also continued to advance our five early-phase projects, as exemplified by the presentation of preclinical data and the pharmacokinetic profile for the MIV-818 liver cancer project at medical conferences globally including the EASL International Liver Congress™ in Europe and the AACR Annual Meeting in the US. We expect to complete preclinical studies with MIV-818 at the end of 2017 to enable a Phase I study start in 2018.

Medivir added the Chief Medical Officer position to the executive leadership team, to focus on the clinical development pipeline. I was pleased to be able to promote John Öhd, who was previously Director Clinical R&D, into the role.

Partnered projects

Additional data from an ongoing phase II study in HCV with JNJ-4178 (triple combination of simeprevir, odalasvir and AL-335) being conducted by our partner, Johnson & Johnson, were presented in April at The International Liver Congress™ of EASL. The results demonstrated, amongst other things, that this regimen has the potential to offer high efficacy (100% cure rates) with a shorter treatment duration (6 weeks) than the market's current alternatives. JNJ-4178 was one of the projects highlighted in Johnson & Johnson's "Pharmaceutical Business Review Day" in May, indicating its high priority to our partner. Johnson & Johnson expects to complete the phase II studies in 2017.

Royalties attributable to OLYSIO® (simeprevir), totalled SEK 7.7 million during the second quarter, reflecting the flattening-out of sales of that product.

As previously announced, Medivir's internal activities are focused on oncology and projects in other areas are consequently being out-licensed.

With the many projects that we have in various stages of development, Medivir looks forward to a very exciting second half of 2017.

Christine Lind
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 25 July 2017.

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