5 May 2011 -- Huddinge, Sweden - Medivir AB (OMX: MVIR), a research-based specialty pharmaceutical company focused on infectious diseases, today announces its financial results and business update for the first quarter ending 31 March 2011.
Ron Long, CEO Medivir commented, “Medivir has had an excellent start to the year with considerable progress in a number of important areas of the business. Our lead project TMC435, a next generation protease inhibitor for hepatitis C, has reported further positive clinical data from its phase 2b clinical trials and has also commenced phase 3 clinical trials. A second hepatitis C development program, TMC649128, a polymerase inhibitor, started phase 1 clinical trials with our partner Tibotec Pharmaceuticals and indicates our continued drive and commitment within the important area of infectious disease.
On the commercial front Xerese™ our treatment for cold sores was launched in the USA by our partner Meda and this will trigger royalty flows as the product gains market share, trading on the practical advantage of being able in many cases to prevent cold sores occurring rather than just alleviating the symptoms of the disease as competing products do.
We are also delighted to announce post-period end our intention to acquire BioPhausia a profitable Nordic-focused specialty pharmaceutical company also located in Stockholm. This transaction, if approved, will provide Medivir with the infrastructure platform that is needed for TMC435 in the Nordic Region where Medivir has retained full commercial rights. It will also enable Medivir to in-license other specialty pharmaceutical products in order to build on the profits that are already being generated by BioPhausia”.
Financial highlights Q1 2011:
- Consolidated net sales were SEK 121.6m compared to SEK 21.6m in Q1 2010
- Consolidated profit/loss after tax for the period was SEK 52.9m compared to SEK -26.2m in Q1 2010
- Earnings per share for the period were SEK 1.85 compared to SEK -1.25 in Q1 2010
- Cash flow from operating activities was SEK -1.2m compared to SEK 32.0m in Q1 2010
- Cash and cash equivalents and investments in securities etc. at the end of the period were SEK 645.7m compared to SEK 184.1m in Q1 2010
Business Highlights for the First Quarter Include:
- Global phase 3 clinical trial program started for TMC435 for the treatment of hepatitis C in treatment naïve patients and patients that relapsed pervious SoC treatment. A milestone payment of EUR 5m was recognized as income based on the phase 3 start
- Further positive data reported from the phase 2b PILLAR (C205) study of TMC435 in treatment-naïve patients with hepatitis C
- The launch of Medivir’s unique cold sore product Xerese™ in the US by our partner Meda
- EUR 7 million milestone triggered by start of phase 1a trial of the hepatitis C virus (HCV) polymerase inhibitor, TMC649128 in collaboration with Tibotec
- Start of a joint research and development program for Dengue Fever with Janssen Pharmaceutica
Post-Period End Highlights:
- Further positive week 24 interim results from TMC435 hepatitis C phase 2b ASPIRE (C206) study in treatment experienced patients reported at the annual meeting of the European Association for the Study of the Liver, EASL
- In order to strengthen Medivir’s commercial capabilities in the Nordic market an offer to acquire BioPhausia, a profitable Nordic specialty pharma company was announced.
For more information, please contact
Rein Piir, CFO and VP, Investor Relations, mobile: +46 (0)70 853 7292.
Conference call for analysts and investors:
There will be a conference call today, May 5 2011, for investors and sell-side analysts at 07:30 (EDT) / 12:30 (GMT) / 13:30 (CET) to discuss this report. To dial-in to the conference call please use the following numbers and quote you would like to join the Medivir call:
Participant Telephone Numbers:
+1 212 444 0481 USA
+46 (0)8 5051 3786 Sweden
+44 (0)20 7136 2053 UK
To access a 7 day replay of the conference call, please use the following numbers:
Soundbyte Replay Access Number:
+44 (0)20 7111 1244 UK
+1 347 366 9565 USA
+46 (0)8 5051 3897 Sweden
Replay Access Code: 6342623#
Financial information in 2011
The AGM will be held at 3 p.m. on 5 May at IVA’s konferenscenter, Grev Turegatan 16, Stockholm, Sweden.
The EGM will be held immediately following the annual general meeting of the Company, to commence at the earliest at 4.30 p.m. on 5 May at IVA’s konferenscenter.
The Six-month Interim Report will be published on 8 July.
The Nine-month Interim Report will be published on 22 October.
Additional information on Medivir’s operations is available on the Company’s website, www.medivir.com
