Interim Report, 1 January – 31 March 2013*
Q1 2013 (January-March)
- Net turnover totalled SEK 282.6 million (SEK 137.9 m).
- The profit/loss after tax was SEK 77.6 million (SEK -37.7 m).
- Basic and diluted earnings per share totalled SEK 2.48 (SEK -1.21).
- The cash flow from operating activities amounted to SEK -19.1 million (SEK -45.8 m), while liquid assets and short-term investments totalled SEK 264.4 million (SEK 485.6 m) at the period end.
Significant events during Q1
- Collaboration agreement was reached for phase II combination trials with simeprevir, TMC647055 and IDX719.
- Registration application for simeprevir was filed with the Japanese Ministry of Health & Welfare and the FDA in the USA, triggering a EUR 15 million-milestone payment to Medivir. The applications refer to treatment of adults with chronic HCV genotype 1.
- The results of the first part of the phase IIa trial of simeprevir and sofosbuvir in hepatitis C patients who had not responded to previous treatment were presented.
- The R&D organisation was divided into two parts and the R&D leadership strengthened and augmented.
- The Nomination Committee submitted its proposal for a new Board of Directors ahead of the 2013 Annual General Meeting.
Significant events after the end of Q1
- Simeprevir trial results were presented at the EASL meeting in Amsterdam on 24-28 April.
- A registration application for simeprevir was filed in Europe for the treatment of adults with chronic HCV genotypes 1 and 4.
|CONSOLIDATED EARNINGS TREND||2013||2012||2012|
|SUMMARY (SEK M)||Jan-March||Jan-March||Jan-Dec|
|Operating profit/loss before depreciation and amortisation (EBITDA)||84.7||-29.9||-151.0|
|Operating profit/loss (EBIT)||83.0||-38.3||-185.8|
|Profit/loss before tax||83.0||-37.5||-192.9|
|Profit/loss after tax||77.6||-37.7||-219.1|
|Operating margin, %||29.4%||-27.8%||-33.5%|
|Basic and diluted earnings per share, SEK||2.48||-1.21||-7.01|
* All figures are for the Group, unless otherwise stated. Comparisons in this Interim Report are, unless otherwise stated, with the corresponding period in 2012.
The CEO’s comments on Q1 2013
“An historic quarter in Medivir’s history when registration applications for Simeprevir were filed in several parts of the world.”
We started the year with a number of very positive events for simeprevir, a potent protease inhibitor now in late clinical phase III development for the treatment of patients with hepatitis C. Registration applications for simeprevir were filed in Japan and the USA during the quarter, yielding a EUR 15 million-milestone payment for Medivir. A registration application for market approval was also filed in Europe in April. The application is for treatment once a day with simeprevir for twelve weeks together with pegylated interferon and ribavirin. Simeprevir is being developed in collaboration with our partner, Janssen.
The results of the first interferon- and ribavirin-free trials of simeprevir and sofosbuvir were also presented during the first quarter. The results met our high expectations and are another step towards achieving our goal of developing a completely interferon- and ribavirin-free treatment. The second part of this combination trial is now in progress and the results are scheduled for presentation in the autumn.
The clinical collaboration agreement reached between Janssen and Idenix was another important milestone for simeprevir during the quarter. The agreement covers phase II combination trials of simeprevir, TMC647055 and IDX719 and the intention is to evaluate an oral, interferon-free antiviral combination therapy for the treatment of hepatitis C. This trial will mean that there are currently five different ongoing interferon- and ribavirin-free trials involving simeprevir.
The company’s research organisation was strengthened with the recruitment of Dr Richard Bethell who will be responsible for Medivir’s preclinical research. Richard joins us from Boehringer Ingelheim in Canada, where he worked as the Director of Biological Sciences. Charlotte Edenius will head up the development organisation and will be in charge of pharmaceutical development work after the selection of a candidate drug.
We are convinced that the coming year will be an eventful one. Registration applications for simeprevir that have been filed in Japan, the USA and Europe are currently being reviewed by the pharmaceutical regulatory authorities and are progressing towards their anticipated approval. We are also, at the same time, making preparations aimed at generating the optimum preconditions for our own launch in the Nordic region during the first half of 2014.
The company’s business operations
Our pharmaceutical sales developed according to plan during the quarter with Mollipect, Citodon, Lithionit, Laxabon and Paraflex responsible for the biggest sales. The marketing department is currently working hard on preparations for an expected market introduction of simeprevir in the Nordic region in 2014 and this work is proceeding according to plan.
Research and Development
We have a strong focus on hepatitis C research and the data presented at a scientific congress in March shows that we are making good progress. The collaboration agreements reached for combination trials of simeprevir and other compounds for the treatment of hepatitis C also prove that simeprevir has the potential to become an important component of any future treatment that is completely interferon- and ribavirin-free.
Data from the cathepsin K trial is currently being compiled and analysed and our goal is to present these data during the coming months. We have also developed compounds for final evaluation prior to the selection of candidate drugs within the framework of the cathepsin S-project.
Medivir and our partner, Janssen R&D, have taken a joint decision to wind up the activities in the early preclinical collaboration on the dengue project as, despite taking a multipronged approach, we have failed to make the progress necessary to justify further investment.
Parallel imports via Cross Pharma
The first quarter saw a positive net turnover trend for Cross Pharma, and we are currently endeavouring to expand the product portfolio in order to offer the pharmacy chains a wider range of pharmaceuticals with increased growth as a result.
President & CEO
For further information, please contact:
Rein Piir, EVP Corporate Affairs & IR, +46 (0) 708 537292
Maris Hartmanis, President & CEO +46 (0)8 5468 3113
Conference call for investors, analysts and the media
The Interim Report for the first quarter of 2013 will be presented by the CEO, Maris Hartmanis, and members of Medivir’s management group.
Time: Monday, 6 May 2013 at 16.30 (CET).
Phone numbers for participants from:
Sweden +46 (0)8 505 204 24
Europe +44 (0) 20 3003 2666
USA +1 866 966 5335
The conference call will also be streamed via a link on the website: www.medivir.se
Financial calendar, 2013
The Annual General Meeting will be held on 6 May at 14.00 (CET)
The Interim Report for January-June will be published on 22 August
The Interim Report for January-September will be published on 21 November