HUDDINGE, Sweden--(BUSINESS WIRE)--Regulatory News:
Q2 2013 (April – June) Remaining Group operations, excluding Cross Pharma
· Net turnover totalled SEK 40.7 million (SEK 39.0 m).
· The profit/loss after tax was SEK -63.7 million (SEK -65.4 m).
· Basic and diluted earnings per share totalled SEK -2.04 (SEK -2.09).
· The cash flow from operating activities amounted to SEK -8.3 million (SEK -5.2 m), while liquid assets and short-term investments totalled SEK 279.9 million (SEK 409.6 m) at the end of the period.
First six months (January – June) Remaining Group operations, excluding Cross Pharma
· Net turnover totalled SEK 218.8 million (SEK 85.2 m).
· The profit/loss after tax was SEK 7.5 million (SEK -107.2 m).
· Basic and diluted earnings per share totalled SEK 0.24million (SEK -3.43 m).
· The cash flow from operating activities amounted to SEK -27.2 million (SEK -51.0 m), while liquid assets and short-term investments totalled SEK 279.9 million (SEK 409.6 m) at the end of the period.
Significant events during Q2
· Positive results from the phase III studies, QUEST-1 and -2, with simeprevir in treatment-naïve patients were reported.
· Positive results from the phase III study, PROMISE, with simeprevir in treatment-experienced patients were reported.
· Positive efficacy and safety data from four phase III Japanese studies, CONCERTO 1-4, of simeprevir were reported.
· The U.S. Food and Drug Administration (FDA) granted a Priority Review for simeprevir.
· Marketing Authorisation Application for simeprevir for the treatment of patients with genotype 1 and genotype 4 chronic hepatitis C was filed with the European Medicines Agency (EMA).
· Interferon-free phase II trial with simeprevir and samatasvir (IDX719) was initiated.
· Positive clinical results from phase Ia study with MIV-711 for treatment of skeletal disorders.
· Medivir divested its wholly-owned subsidiary company, Cross Pharma.
Significant events after the end of Q2
· Increased focus within the company’s proprietary hepatitis C portfolio through reallocation of resources to the nucleotide-based polymerase inhibitor programme and discontinuation of the NS5A programme.
· Medivir received a part payment of SEK 119 million for Cross Pharma. The outstanding balance of SEK 15 million will be paid over a three-year period.
CONSOLIDATED INCOME STATEMENT SUMMARY*
|2013 Apr-June||2012 Apr-June||2013 Jan-June||2012 Jan-June||2012 Jan-Dec|
|Operating profit/loss before depreciation and amortisation (EBITDA)||-46.9||-47.7||43.6||-79.6||-165.3|
|Operating profit/loss (EBIT)||-62.0||-56.4||14.7||-99.0||-201.3|
|Profit/loss before tax||-62.1||-57.0||14.5||-98.4||-210.8|
|Profit/loss after tax||-63.7||-65.4||7.5||-107.2||-234.1|
|Operating margin, %||-152.3||-144.9||6.7||-116.2||-118.0|
|Basic and diluted earnings per share, SEK||-2.04||-2.09||0.24||-3.43||-7.49|
* All figures refer to the remaining Group operations after the divestment of Cross Pharma, unless otherwise stated. Comparisons in this Interim Report are, unless otherwise stated, with the corresponding period in 2012.
The CEO’s comments on Q2 2013
“We streamlined operations and sharpened our focus”
The first half of 2013 was an eventful period and one in which we made important progress in a number of areas.
We streamlined the company’s operations and sharpened the focus on our proprietary prescription pharmaceuticals in the Nordic region by divesting Cross Pharma AB, the wholly-owned subsidiary engaged in parallel imports of pharmaceuticals. The sale of Cross Pharma AB to Unimedic AB further strengthens Medivir’s financial position.
Medivir’s key clinical phase product, simeprevir, has continued to develop according to plan and our partner, Janssen, has filed Marketing Authorisation Applications in three different regions of the world over the course of a two-month period. Simeprevir is now being evaluated by regulatory authorities for approval for the treatment of chronic hepatitis C in three major geographical territories, namely the USA, Europe and Japan and has, as a consequence, moved one step closer to the market. Additional efficacy and safety data were presented for simeprevir during the period. The results confirm that simeprevir, in combination with pegylated interferon and ribavirin, has a high level of efficacy and a good safety profile. In the USA, the FDA decided to grant simeprevir a “Priority Review”, which may shorten the time to market introduction of simeprevir. New interferon-free studies of simeprevir were initiated in partnership with Idenix, and other interferon-free studies proceeded according to plan.
Pharmaceutical sales developed according to plan during the quarter and posted an increase of SEK 1.7 million in comparison with the corresponding period in 2012 while retaining profitability. Mollipect, Citodon and Lithionit continued to be the biggest-selling products.
We recruited Henrik Krook as the new head of Commercial Operations. This recruitment brings in additional expertise and experience of Nordic markets other than Sweden, and this will be important for the establishment of a Nordic marketing organisation.
Medivir’s proprietary protease inhibitor projects against cathepsin K and cathepsin S developed well. The phase I trials with the cathepsin K inhibitor were concluded, and the data obtained from the phase Ib trials are now being analysed. The results will be presented at a scientific congress later this year. The cathepsin S project is currently evaluating a number of compounds and we are planning to select a candidate drug during the latter half of the year for further development and preparation for clinical trials.
In August we decided, within the framework of Medivir’s proprietary hepatitis C project, to focus our resources on the polymerase inhibitor programme as there is a clear need for nucleotide-based polymerase inhibitors. We also decided, at the same time, to discontinue our hepatitis C NS5A inhibitor programme as the competitive landscape includes numerous NS5A programmes with a similar profile.
President & CEO
Conference call for investors, analysts and the media
The Interim Report for the second quarter of 2013 will be presented by the CEO, Maris Hartmanis, and members of Medivir’s management group.
Time: Thursday, 22 August 2013 at 14.00 (CET).
Phone numbers for participants from:
Sweden +46 (0) 8 505 564 77
Europe +44 (0) 20 336 453 72
USA +1 877 788 9023
The conference call will also be streamed via a link on the website, www.medivir.com
Financial calendar, 2013
The Interim Report for January–September will be published on 21 November 2013.
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