Interim Report, 1 January-30 September 2012*

Interim period, January-September 2012

• Net turnover totalled SEK 399.5 million (SEK 566.8 m), of which non-recurrent payments comprised SEK 0.0 million (SEK 401.2 million), sales of pharmaceuticals, SEK 120.6 million (SEK 63.7 m), and sales via parallel imports, SEK 277.7 million (SEK 101.2 m).
• The profit/loss after tax was SEK -153.8 million (SEK 166.9 m).
• Basic and diluted earnings per share totalled SEK -4.92 (SEK 5.58).
• The cash flow from operating activities amounted to SEK -90.0 million (SEK 44.7 m), while liquid assets and short-term investments totalled SEK 356.6 million (SEK 550.0 m) at the period end.

Q3, July-September 2012

• Net turnover totalled SEK 114.4 million (SEK 122.2 m), of which sales of pharmaceuticals comprised SEK 35.4 million (SEK 47.4 m) and sales via parallel imports, SEK 77.8 million (SEK 74.6 m).
• The profit/loss after tax was SEK -55.2 million (SEK -53.4 m).
• Basic and diluted earnings per share totalled SEK -1.77 (SEK -1.71).

Significant events during Q3

• A third interferon-free phase II combination trial of simeprevir (TMC435) and TMC647055 began in September. The study includes both previously untreated HCV patients (treatment-naïve) and patients who had previously failed to respond to therapy (treatment-refractory).
• Preclinical research programmes and prodrug technologies were acquired, complementing the company’s research in the field of hepatitis C.

Significant events after the end of the Q3

• Phase II data for simeprevir was presented in November 2012 in Boston, at the AASLD (American Association for the Study of Liver Diseases) Annual Liver Meeting.
• A fourth interferon-free phase II trial of simeprevir in combination with Vertex’s nucleotide polymerase inhibitor, VX-135, for the treatment of hepatitis C, is scheduled to begin in early 2013.

* All figures are for the Group, unless otherwise stated. Comparisons in this Interim Report are, unless otherwise stated, with the corresponding period in 2011. The BioPhausia corporate group is included from 31 May 2011.

The CEO’s comments on Q3 2012

“A more focused project portfolio and development according to plan for Simeprevir”
Medivir’s commercial operations continued stable during the third quarter. Original pharmaceuticals provide a platform for the long-term creation of new business opportunities. Cross Pharma continued to invest in the registration of new products as part of its growth strategy and posted a year-on-year increase in turnover. This is the eighth quarter in succession in which Cross Pharma has posted a year-on-year increase in turnover.

The global phase III trials of simeprevir (TMC435) proceeded according to plan and the results are expected around year-end. These results will provide the basis for the registration of simeprevir in the USA, Europe and Japan and we anticipate submitting the various registration files to the respective authorities during the first half of 2013.

Medivir acquired early antiviral, preclinical research programmes from Novadex Pharmaceuticals AB during the quarter. The acquisition included unique intellectual property rights to the projects and prodrug technologies, and sees Medivir expanding its technical platform and strengthening its position in the hepatitis C research sphere.

Medivir’s two in-house hepatitis C projects – one NS5A inhibitor program and one in the field of nucleotide polymerase inhibitors – developed and proceeded according to plan. The in-house projects outside the virus sphere – cathepsin K for the treatment of skeletal disorders, which is in clinical phase I, and cathepsin S for the treatment, primarily, of neuropathic pain and which is in the preclinical phase – proceeded largely according to plan.

We have carried out a review of the existing project portfolio during the quarter and have wound up two collaborative projects as our partners lack the necessary resources to continue with the projects. The wound up projects are MIV-410 (collaboration with Presidio in the USA) and MIV-606 (collaboration with Epiphany in the USA).

The Pharmaceuticals Business Area
The Pharmaceuticals Business Area comprises the Group’s research and development projects, the Xerclear® cold sore pharmaceutical, and the original pharmaceuticals owned by our wholly owned subsidiary company, BioPhausia. Sales of original pharmaceuticals continued to show a stable underlying trend during the third quarter and the operating performance ratio was maintained. The third quarter saw Mollipect, Citodon and Lithionit retain their positions as Medivir’s best-selling pharmaceuticals and net turnover from pharmaceutical sales during the third quarter totalled SEK 35.4 million (SEK 47.7 m). Turnover for the corresponding period last year included SEK 5.5 million in sales of generics from BMM Pharma, which has now been sold. EBITDA for the period totalled SEK -40.8 million (SEK -47.3 m). EBIT includes research and development costs of SEK -46.5 million (SEK -34.1 m).

Parallel imports via Cross Pharma
Cross Pharma’s positive turnover trend continued during the third quarter with sales rising to SEK 77.8 million (SEK 74.6 m), corresponding to a year-on-year increase in turnover. Cross Pharma’s growth strategy meant that the company’s investments − primarily aimed at expanding the pharmaceutical portfolio − continued to depress the operating margin, which consequently fell in comparison with the previous quarter. EBITDA for the quarter totalled SEK 2.2 million (SEK -3.1 m).

R&D
Simeprevir – Medivir’s protease inhibitor for the treatment of hepatitis C in clinical phase III trials
A further interferon-free phase IIa trial of simeprevir has recently begun. Simeprevir will be evaluated in combination with TMC647055, a potent non-nucleotide polymerase inhibitor developed by our partner, Janssen. Approximately 40 patients with HCV genotype 1a or 1b will enrol in the study.

A clinical collaboration agreement was reached in November, after the end of the reporting period between Janssen and the American pharmaceutical company, Vertex. The collaboration will entail trials of simeprevir in combination with Vertex’s nucleotide polymerase inhibitor, VX-135, as part of an interferon-free phase II trial for the treatment of hepatitis C.

In-house hepatitis C projects
The aim of our in-house NS5A project is to address the weaknesses of the first generation NS5A inhibitors in clinical development, and we have made good progress in this respect. Our internal project working with nucleotide polymerase inhibitors has recently been expanded through the acquisition of Novadex – a move that has generated interesting potential with regard to designating a future candidate drug.

Cathepsin K
A phase Ib trial of our in-house developed candidate drug, MIV-711, began in August. An amendment of this trial entailing the extension of the treatment period from 14 days to 28 days for post-menopausal women is enabling additional valuable information to be gathered. Extending the treatment period allows additional data to be obtained with regard to the biomarkers under study, thereby increasing the potential for gathering valuable information on the effects on cartilage and bone resorption. The extended treatment period is supported by the data generated to date by the ongoing trials but also means that the final results of the trial will be postponed until the end of the first quarter of 2013.

Maris Hartmanis
President & CEO

For further information, please contact:
Rein Piir, EVP Corporate Affairs & IR: +46 (0)708 537292
Maris Hartmanis, CEO: +46 (0)8 5468 3113

Conference call for investors, analysts and the media
The Interim Report will be presented by the CEO, Maris Hartmanis, and members of Medivir’s management group.

Time: Tuesday, 20 November 2012 at 14.00 (CET)

Phone numbers for participants from:    Sweden           0200 89 63 77
                                                                        Europe           +44 (0)20 3003 2666
                                                                        USA                +1 866 966 5335 

The conference call will also be streamed live via a link on the website: www.medivir.se

Financial calendar, 2013
The Financial Statement for January-December will be published on 22 February 2013
The Interim Report for January-March will be published on 6 May 2013.
The Annual General Meeting will be held on 6 May 2013

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