Financial Statement, 1 January – 31 December 2013*
Financial summary for the year as a whole. Continuing Group operations, excluding Cross Pharma.
- Net turnover totalled SEK 446.1 million (SEK 170.6 m), SEK 258.5 (4.4) million of which represented non-recurrent payments.
- The profit/loss after tax was SEK 16.0 million (SEK -234.1 m).
- Basic and diluted earnings per share totalled SEK 0.51 (SEK -7.49).
- The cash flow from operating activities amounted to SEK 43.0 million (SEK -139.5 m), while liquid assets and short-term investments totalled SEK 402.2 million (SEK 296.7 m) at the period end.
Q4 2013 (October - December). Continuing Group operations, excluding Cross Pharma.
- Net turnover totalled SEK 147.1 million (SEK 48.8 m), SEK 88.0 (4.4) million of which represented non-recurrent payments.
- The profit/loss after tax was SEK 19.3 million (SEK -70.6 m).
- Basic and diluted earnings per share totalled SEK 0.62 (SEK -2.26).
- The cash flow from operating activities amounted to SEK 75.6 million (SEK -49.5 m), while liquid assets and short-term investments totalled SEK 402.2 million (SEK 296.7 m) at the period end.
- Positive data were obtained from the phase I study with MIV-711 (cathepsin K) for the treatment of osteoarthritis and other bone-related disorders. MIV-247 (a cathepsin S inhibitor) was selected as a candidate drug and has entered pre-clinical development for the treatment of neuropathic pain.
- Simeprevir was approved in Canada and the USA for the treatment of hepatitis C, and was made available to patients in Japan, the USA and Canada.
- The first royalty from global pharmaceutical sales totalled SEK 10.5 million.
- Positive data were reported from two phase III studies of simeprevir in hepatitis C subpopulations – HCV/HIV co-infected and HCV genotype 4 infected patients.
- Positive results were presented from the COSMOS study with simeprevir and sofosbuvir in cirrhotic and non-cirrhotic patients.
- A phase II combination study with simeprevir, TMC647055 and samatasvir (IDX719) was initiated.
- A phase IIa combination study with simeprevir, TMC647055 and JNJ56914845 (GSK805) was initiated.
Significant events after the end of Q4
- Interim results from a phase II combination study with simeprevir and samatasvir (IDX719) were presented.
- Medivir’s Board has decided to initiate a process to find a new CEO with a strong marketing and sales profile to lead and develop the company´s business further. Maris Hartmanis will remain as Medivir’s CEO until his successor has taken up the position.
|CONSOLIDATED INCOME STATEMENT SUMMARY*||2013||2012||2013||2012|
|Continuing operations (SEK m)||Oct-Dec||Oct-Dec||Jan-Dec||Jan-Dec|
|Operating profit before depreciation and amortisation (EBITDA)||32.0||-44.9||76.4||-165.3|
|Operating profit (EBIT)||20.6||-53.8||25.2||-201.4|
|Profit/loss before tax||22.8||-58.7||27.7||-210.8|
|Profit/loss after tax||19.3||-70.6||16.0||-234.1|
|Operating margin, %||14.0||-110.0||5.6||-118.0|
|Basic and diluted earnings per share, SEK||0.62||-2.26||0.51||-7.49|
* All figures refer to the Group, unless otherwise stated. Comparisons in this Interim Report are, unless otherwise stated, with the corresponding period in 2012. Cross Pharma was divested from the Group on 30 June 2013.
The CEO’s comments on 2013
“Patients with hepatitis C can now be treated with Simeprevir in Japan, Canada and the USA”
2013 was a successful and intensive year. We made important progress in our in-house projects during the year, and simeprevir was approved for the treatment of patients with genotype 1 chronic hepatitis C virus. This means that simeprevir is now available to patients in a number of important markets and that seriously ill patients can be treated with the drug. Simeprevir was approved in Japan in September and in the USA and Canada in November 2013. Simeprevir generated milestone payments corresponding to EUR 30 million during the year. Our partner, Janssen, filed a marketing authorisation application for simeprevir to the European Medicines Agency (EMA) in April 2013, and we anticipate European approval during the first half of 2014. We also received the first royalty income for simeprevir, totalling SEK 10.5 million for December.
A number of important structural changes were also carried out within the company during the year. We streamlined the company’s operations by divesting Cross Pharma AB and conducted a review of our project portfolio, which resulted in more focused activities.
Research and development
One of the important goals of the further development of simeprevir is to produce a completely interferon-free and ribavirin-free treatment. Two additional interferon-free phase II studies, now with the addition of two direct acting antiviral agents to simeprevir, were accordingly initiated during the fourth quarter. In the first study, the patients will be treated with simeprevir, TMC647055 and two different doses of JNJ56914845, without ribavirin, while in the other study, HELIX-2, simeprevir, samatasvir and TMC647055 will be evaluated, with and without ribavirin.
Positive interim data from the interferon-free COSMOS study were presented in November. The aim was to study the efficacy and safety of combination treatment with simeprevir and sofosbuvir, with or without ribavirin, in the most difficult-to-treat patient groups. Additional data from this study will be presented in 2014.
In October 2013, the cathepsin S inhibitor, MIV-247, was designated as a candidate drug for the treatment of neuropathic pain. MIV-247 therefore enters pre-clinical development.
The in-house developed cathepsin K inhibitor, MIV-711, for the treatment of bone-related disorders showed positive results in clinical phase I studies now completed.
Work on nucleotide-based polymerase inhibitors targeting hepatitis C has continued successfully during the year.
These events all illustrate the clear progress being made by our in-house projects.
Our pharmaceutical portfolio generated solid full-year sales of SEK 176.1 million, corresponding to a year-on-year growth of 7% in net turnover and of 4% in the number of units sold. We have established a strong Nordic sales organisation during the year, with an increased presence in the Nordic countries. This is an important stage in our preparations for the market launch of new specialist pharmaceuticals such as simeprevir and Adasuve.
2013 saw the 25th anniversary of Medivir’s foundation as a company. It is impressive to see how much has happened over these years. Today, Medivir is a growing Nordic pharmaceuticals company that combines successful research and development activities with a strong Nordic commercial pharmaceutical sales organisation. Now that simeprevir has reached the market, the company will enter a commercialisation phase that brings new opportunities and challenges.
We look forward to an eventful 2014 that will see continued growth and important steps in the development and provision of innovative pharmaceuticals that improve peoples’ health and quality of life.
President & CEO
For further information, please contact:
Rein Piir, EVP Corporate Affairs & IR, +46 (0) 708 537292
Maris Hartmanis, President & CEO, +46 (0) 8 407 64 30
Göran Pettersson, Chairman of the Board, +46 (0) 70 445 0301
Conference call for investors, analysts and the media
The 2013 Financial Statement will be presented by the CEO, Maris Hartmanis, and members of Medivir’s management group.
Date: 24 February 2014
Time: 14.00 (CET)
Phone numbers for participants from:
Sweden +46 (0) 8 505 564 87
Europe +44 (0) 20 7660 2078
USA +1 855 716 1592
The conference call will also be streamed via a link on the website, www.medivir.com
The Annual General Meeting will be held on 8 May 2014.
The Interim Report for January-March will be published on 8 May 2014.
The Interim Report for January-June will be published on 21 August 2014.