22 February 2011 -- Medivir AB (OMX: MVIR), a research-based specialty pharmaceutical company focused on infectious diseases, is publishing its Financial Statement today for the period 1 January – 31 December 2010 and a business update for the fourth quarter 2010.
Major advances in hepatitis C create the prospects for a dynamic 2011
“Medivir took several very important developmental steps in 2010 and made significant advances in its important hepatitis C projects. The recently commenced global pivotal phase 3 trials on TMC435 for treating chronic hepatitis C virus infection is the most important development to date. Medivir also made several advances in other research projects, in tandem with Xerclear®/Xerese™ now approaching its launch on the major markets, which means the company making further progress towards its goal of being a profitable specialty pharmaceutical company. There has been very positive progress for our early stage hepatitis C projects and we have also strengthened our infectious diseases portfolio. In future, we also intend to retain more of the commercial value of our projects. The agreement on dengue fever based on co-development with Janssen Pharmaceutica N.V. is a recent example of this. We have extended our shareholder base internationally, while retaining strong relations with the shareholders that have supported Medivir for many years,” commented CEO Ron Long.
Financial highlights 2010
• Consolidated net sales were SEK 57.3 (25.7) m.
• The consolidated profit/loss after tax for the period was SEK -134.2 (135.4) m.
• Earnings per share for the period were SEK -5.43 (-6.49).
• Cash flow from operating activities was SEK -76.9 (-135.1) m.
• Cash and cash equivalents and investments in securities etc. at the end of the period were SEK 647.2 (143.6) m.
• A rights issue raised SEK 325.1 m before issue costs
• A private placement raised SEK 281.3 m before issue costs
Fourth quarter operational highlights
• Medivir published further positive data for TMC435 in November. Interim data after 24 weeks’ treatment in the ASPIRE trial (C206), a phase 2b trial on non responders, demonstrated highly potent anti-viral efficacy and a very positive safety profile. These characteristics make TMC435 potentially the leading protease inhibitor in development for treating HCV.
• In December, Medivir implemented a private placement of 2,250,000 shares, which raised SEK 280 m (EU 30.8 m). 30 institutional investors and professional investors in Sweden participated in the accelerated book-building process at a price of SEK 125 per share. Of these over two-thirds of the new shares were subscribed by international investors. The purpose of this capital raising was to provide Medivir with the possibility of realizing its R&D strategy and the build-up of its commercial organization.
• In December, the Medivir share qualified for the Nasdaq OMX Stockholm Exchange Mid-cap List, which it will join from January 2011.
Post period-end highlights
• As of today, Medivir reported positive 48-week interim data (SVR24) from the PILLAR trial (C205), a phase 2b trial on TMC435 on treatment-naive patients. TMC435 demonstrated potent and consistent anti-viral efficacy with SVR24 of up to 84%. According to international standards, these patients are classified as cured.
• The global phase 3 trials on TMC435 started in February, which triggered a milestone payment of EUR 5 m, whose revenue will be recognized in the first quarter 2011.
• A clinical phase 1a trial on TMC649128 (HCV POL) started in February, which entitles Medivir to a EUR 7 m milestone payment.
• In February, Medivir started a new collaboration with Janssen Pharmaceutica (Johnson & Johnson group) to jointly develop a pharmaceutical that can prevent and treat dengue virus infections.
• The BACE project has been discontinued in favor of increased focus on infectious disease projects in the development portfolio.
For more information, please contact
Rein Piir, CFO and VP, Investor Relations, mobile: +46 (0)70 853 7292. Ron Long, CEO, phone: +46 (0)8 546 83113.
Conference call for analysts and investors:
There will be a conference call today, February 22 2011, for investors and sell-side analysts at 09:00 (EDT) / 14:00 (GMT) / 15:00 (CET) to discuss this report. To dial-in to the conference call please use the following numbers:
Participant Telephone Numbers: +1 718 354 1385 USA +46 (0)8 5352 6408 Sweden +44 (0)20 7806 1951 UK
Confirmation Code: 6641746
Alternatively, please contact Lindsey Neville at M:Communications on Tel: +44 (0) 207 920 2333, Email: Neville@mcomgroup.com.
Financial information in 2011 The Three-month Interim Report will be published on 5 May. The AGM will be held at 3 p.m. on 5 May at IVA’s conference centre, Grev Turegatan 16, Stockholm, Sweden. The Six-month Interim Report will be published on 8 July.
Additional information on Medivir’s operations is available on the company’s website, www.medivir.se
