MEDIVIR AB – FINANCIAL STATEMENT, JANUARY – DECEMBER 2016

Significant events during the fourth quarter

  • Medivir focuses research and development operations exclusively on oncology and reorganises in order to achieve significant cost savings. As a result of the operative transformation a non-recurring sum of SEK 49.1 million was charged to the profit/loss for the period and of SEK 52.6 million for the full year.
  • Medivir divests its pharmaceutical company, BioPhausia (Nordic Brands), to Karo Pharma for SEK 908 million and reports a consolidated capital gain of SEK 534.8 million, thereby applying IFRS 5 (see p. 12).
  • Medivir strengthens its clinical pipeline by entering into an agreement on the acquisition of a portfolio of clinical phase oncology programmes, which has increased its intangible fixed assets by SEK 89 million and current receivables by SEK 22 million.

October – December 2016

  • Net turnover for the continuing operations totalled SEK 9.9 million (34.5 m), SEK 5.6 million (31.1 m) of which comprised royalties for simeprevir.
  • Revenues from Medivir’s continuing pharmaceutical sales totalled SEK 2.9 million (2.9 m), of which SEK 2.9 million (2.7 m) derived from sales of OLYSIO®.
  • The profit after tax for the continuing operations was SEK -121.3 million (-56.9 m).
  • Basic and diluted earnings per share totalled SEK -4.50 (-2.11) and SEK -4.50 (-2.11), respectively.
  • The cash flow from operating activities amounted to SEK -69.6 million (-37.6 m).

January – December 2016

  • Net turnover for the continuing operations totalled SEK 93.0 million (474.3 m), SEK 60.3 million (418.6 m) of which comprised full year royalties for simeprevir.
  • Revenues from Medivir’s continuing pharmaceutical sales totalled SEK 12.3 million (53.9 m), of which SEK 12.0 million (53.0 m) derived from sales of OLYSIO®.
  • The profit after tax for the continuing operations was SEK -294.9 million (31.7 m).
  • Basic and diluted earnings per share totalled SEK -10.94 (1.09) and SEK -10.94 (1.08), respectively.
  • The cash flow from operating activities amounted to SEK -180.1 million (307.4 m).
Summary of the Group’s figures (SEK m) Q4 Q1-Q4
Continuing operations
2016 2015 2016 2015
Net turnover 9.9 34.5 93.0 474.3
Gross profit 7.7 30.0 77.1 436.0
Operating profit before depreciation and amortisation (EBITDA) -120.7 -51.9 -278.9 95.7
Operating profit (EBIT) -128.9 -60.4 -312.4 55.4
Profit/loss before tax -129.9 -67.8 -306.7 46.2
Profit/loss after tax -121.3 -56.9 -294.9 31.7
Operating margin, % -1,306.1 -175.3 -335.7 11.7
Basic earnings per share, SEK -4.50 -2.12 -10.94 1.09
Diluted earnings per share, SEK -4.50 -2.12 -10.94 1.08
Net worth per share, SEK 64.38 54.04 64.38 54.04
Return on equity -30.5 -15.5 -18.5 1.8
Cash flow from operating activities -69.6 -37.6 -180.1 307.4
Cash and cash equivalents at period end 1,698.5 1,077.9 1,698.5 1,077.9
R&D spending/total opex, % 65.9 77.8 78.8 73.1

Conference call for investors, analysts and the media
The financial statement for January – December 2016 will be presented by Medivir’s President & CEO, Niklas Prager.

Time: Friday, 17 February 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.

 
CEO’s comments

We took several significant steps in the restructuring of Medivir during the fourth quarter. In all essentials, we completed the transformation of the company that had been in progress throughout the year. A key part of this transformation was the focusing of the company’s operations exclusively onto research and development in the field of oncology. This focus was given extra emphasis with the acquisition of two oncology projects in late development phases, both of which have considerable potential. The acquisition strengthens and balances our research portfolio and gives us a wider range of projects in different phases, shifting the company’s primary focus from early stage research to clinical development.

As a further step in this process, we also divested BioPhausia with its drug portfolio Nordic Brands. After having considered and prepared a separate stock exchange listing of BioPhausia, we judged that a sale to Karo Pharma AB was the best alternative for our shareholders. An Extraordinary General Meeting in early February 2017 endorsed the Board’s proposal that the net proceeds from the sale of SEK 870 million should be distributed to Medivir’s shareholders in the form of a voluntary redemption programme.

We also reorganised the company’s early stage research and administrative functions during the quarter. It is estimated that this will give annual savings totalling approximately SEK 110 million.

Furthermore, we continued to make progress in our research projects during the quarter, both in our internal portfolio and in partner projects. I would like to make particular mention of the fact that we selected two new candidate drugs from our own research portfolio that have now proceeded to preclinical development: MIV-323 for the treatment of RSV infections and MIV-818 for the treatment of liver cancer. In keeping with our new exclusive oncology focus, we will continue to pursue the development of MIV-818 in-house, while for that of MIV-323 we will be seeking a partner.

Along with MIV-802 for the treatment of hepatitis C, which we licensed out to Trek Therapeutics in the third quarter of 2016, these projects are clear indications of the improved productivity of our early stage research operations and ability to continue to produce new, well-differentiated candidate drugs in areas of great unmet medical needs on the basis of our own technology platform.

The osteoarthritis trial MIV-711 proceeded according to plan and is now fully enrolled. As before, we expect to report data from the study during the third quarter of 2017.

In November our partner, Janssen Research & Development, announced that they are building on earlier interesting results by initiating a phase IIb study with the combination of simeprevir, odalasvir and AL-335 for the treatment of hepatitis C.

Q4 royalties attributable to the hepatitis C drug OLYSIO® (simeprevir) amounted to SEK 5.6 million as a result of the decline in global net sales.

The extensive transformation we have now achieved gives me great hope for the future. Our strong, balanced research and development portfolio with a focus on oncology, based on our exciting technology platforms for protease inhibitors and nucleosides/nucleotides, has considerable potential to create long-term value for the shareholders and will generate a continuous news flow in 2017 and the years to come. It is therefore with a sense of pride and great confidence that I feel spring 2017 is the right time to hand over the baton to a new CEO, Christine Lind. I would like to take this opportunity to thank all our engaged shareholders, the Board of Medivir, all our employees and business partners for the stimulating and intense years at the helm of Medivir and I wish the company every success in the future. As a shareholder, I will be following the progress with great interest!

Niklas Prager
President and CEO
 

Upcoming reporting dates:
Interim Report (January – March 2017)

28 April 2017
2017 Annual General Meeting

3 May 2017
Interim Report (January – June 2017)

25 July 2017
Interim Report (January – September 2017)

26 October 2017

 
For further information, please contact:
Niklas Prager, President & CEO, phone: +46 (0) 8 407 64 30
Ola Burmark, CFO, mobile: +46 (0)725-480 580.

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 17 February 2017.

About Medivir
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

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About Us

Medivir is an emerging and profitable research‐based pharmaceutical company with an established marketing and sales organisation in the Nordic region with a broad portfolio of prescription pharmaceuticals.Medivir receives royalties from Johnson & Johnson on the global sales of the hepatitis C pharmaceutical, Olysio®. In addition, revenues for sales of Olysio in the Nordic region are generated through the company’s own sales and marketing organisation. Medivir’s research and development portfolio of pharmaceuticals is based on the company’s expertise within protease inhibitor design and nucleoside/nucleotide science. The company’s research and development focus is within infectious diseases and oncology and the on-going clinical projects in osteoarthritis and neuropathic pain. Medivir is listed on the Nasdaq Stockholm Mid Cap List.