Medivir AB (OMX: MVIR), a research-based specialty pharmaceutical company focused on infectious diseases, is publishing its interim report today for the period covering 1 January - 30 September and a business update for the third quarter 2010.
Financial Highlights 1 January - 30 September - Consolidated net sales were SEK 54.7 (24.5) m. - The consolidated profit/loss for the period was SEK -77.6 (-93.0) m. - Earnings per share for the period were SEK -3.30 (-4.46). - Cash flow from operating activities was SEK -35.0 (-104.8) m. - Cash and cash equivalents and investments in securities etc. at the end of the period were SEK 421.8 (176.1) m. Third Quarter Operational Highlights - Positive phase 2b interim PILLAR data presented in July on TMC435, Medivir's lead development drug for Hepatitis C (HCV) infections. These data demonstrate that TMC435 has potent antiviral effect and an attractive safety profile, properties making TMC435 the best in class investigational HCV drug under development. - To realise the maximum commercial value in different markets, another two distribution partnering deals have been entered for Xerclear(R)/Xerese(R), an innovative treatment for cold sores, with Daewoong and Luxembourg. This is in addition to Medivir's agreement with GlaxoSmithKline for OTC sales in Europe and other key territories and the agreement with Meda for Rx sales in North America. During the ongoing preparations for this introduction to the market, the launch of Xerese(R) in North America has been confirmed for the first quarter of 2011. - The early-stage antiviral project portfolio, focusing on new approaches to treat HCV and other infectious diseases, is progressing well. Post Period End Highlights - Medivir announced in early October that new results with TMC435 will be presented at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston in late October 2010. This will be via a late breaking oral presentation on TMC435 phase 2b ongoing studies and four additional poster presentations on data regarding
efficacy and safety and pharmacokinetic data of TMC435.
A comment from Ron Long, Medivir's CEO:
"Medivir has continued to make important progress in the third quarter of this year on the route towards becoming a successful specialty pharmaceutical company operating on an international stage. Our lead development product, TMC435, has blockbuster potential in the exciting Hepatitis C therapy arena. TMC435 is demonstrating extremely positive data in phase 2b trials, with clear competitive advantages. We look forward to the presentation of week-24 interim results at the AASLD meeting in Boston in October.
We have also worked hard during this quarter to ensure that we increase the commercial value of our innovative cold sore product Xerclear(R)/Xerese(R ) and have signed two further agreements in different geographic markets.
The success demonstrated with Xerclear(R) and Xerese(R) shows Medivir's ability to develop and commercialize products and collaborate with blue-chip partners.
Following the successful rights issue concluded in June 2010 we are in healthy financial position and have therefore been able to remain focused on developing our exciting portfolio of early-phase projects for infectious diseases.
Medivir is positioned uniquely among specialty pharmaceutical companies with a potential blockbuster Hepatitis C therapy in late-stage development, a marketed product, Xerclear(R)/Xerese(R), approaching international launch, a broad earlier pipeline and a solid financial position. Medivir will now remain focused on creating further shareholder value and continues to gain momentum in its strategic goal to become a profitable specialty pharmaceutical company. We look forward to sharing our exciting future news flow going forward with both our patients and our shareholders as we continue to build the growth in this business."