Interim Report, 1 January – 30 September 2013*
Q3 2013 (July-September) Remaining Group operations, excluding Cross Pharma
- Net turnover totalled SEK 80.2 million (SEK 36.6 m), SEK 43.6 million (EUR 5 m) of which represented milestone payments.
- The profit/loss after tax was SEK -10.7 million (SEK -56.2 m).
- Basic and diluted earnings per share totalled SEK -0.34 (SEK -1.80).
- The cash flow from operating activities amounted to SEK -5.2 million (SEK -39.1 m), while liquid assets and short-term investments totalled SEK 337.7 million (SEK 356.6 m) at the end of the period.
Interim period (January-September) Remaining Group operations, excluding Cross Pharma
- Net turnover totalled SEK 299.0 million (SEK 121.8 m), of which SEK 170.5 million (EUR 20 m) represented milestone payments.
- The profit/loss after tax was SEK -3.3 million (SEK -163.5 m).
- Basic and diluted earnings per share totalled SEK -0.11 (SEK -5.23).
- The cash flow from operating activities amounted to SEK -32.5 million (SEK -90.0 m), while liquid assets and short-term investments totalled SEK 337.7 million (SEK 356.6 m) at the end of the period.
Significant events during Q3
- Medivir focused the in-house hepatitis C projects to those involving nucleotide-based polymerase inhibitors.
- Medivir discontinued its collaboration with Daewoong Pharmaceutical Co. Ltd. regarding the development of MIV-210.
- Medivir and Ferrer entered into an agreement for the commercialisation of a new treatment for agitation associated with schizophrenia and bipolar disorder in the Nordic region.
- Simeprevir was approved in Japan for the treatment of genotype 1 chronic hepatitis C virus patients, triggering a milestone payment of EUR 5 million to Medivir.
Significant events after the end of Q3
- Simeprevir will be evaluated for interferon-free treatment of genotype 1 chronic hepatitis C patients in combination with an NS5A replication complex inhibitor acquired by Janssen.
- Positive results from a phase l study with MIV-711 for the treatment of osteoarthritis and other bone-related disorders were presented.
- MIV-247 was selected as a candidate drug and has entered pre-clinical development for the treatment of neuropathic pain.
- Two phase III studies with simeprevir in HCV/HIV co-infected and HCV genotype 4 infected patients showed good efficacy.
- FDA Advisory Committee recommended simeprevir for market approval.
- The interim results from the COSMOS study with simeprevir and sofosbuvir showed good results in difficult-to-treat patients.
- Simeprevir was approved in Canada as a new treatment for hepatitis C.
|CONSOLIDATED INCOME STATEMENT
|Remaining operations (SEK m)||July-Sept||July-Sept||Jan-Sept||Jan-Sept||Jan-Dec|
|Operating profit/loss before depreciation and amortisation (EBITDA)||0.8||-40.8||44.4||-120.4||-165.3|
|Operating profit/loss (EBIT)||-10.1||-48.6||4.6||-147.6||-201.4|
|Profit/loss before tax||-9.6||-53.7||4.9||-152.1||-210.8|
|Profit/loss after tax||-10.7||-56.2||-3.3||-163.5||-234.1|
|Operating margin, %||-12.5||-132.7||1.5||-121.2||-118.0|
|Basic and diluted earnings per share, SEK||-0.34||-1.80||-0.11||-5.23||-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 Q3 2013
“Simeprevir has been approved in Japan and Canada for the treatment of chronic hepatitis C”
At the end of September, simeprevir was approved by the Japanese Ministry of Health, Labour & Welfare for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. This is the first market approval of simeprevir and we are naturally proud of this achievement. The number of patients with chronic HCV infection in Japan is estimated at 1.5 to 2 million.
In October, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted in favour of market approval for simeprevir in the USA in what is a massive step towards the market introduction of simeprevir in the USA. In November the pharmaceutical authority in Canada, Health Canada, approved simeprevir for the treatment of chronic hepatitis C virus genotype 1. It is the first treatment for hepatitis C to be approved in Canada for once-daily use.
We have developed simeprevir in collaboration with our partner, Janssen. The treatment now approved in Japan involves administering simeprevir in combination with ribavirin and pegylated interferon. Treatment with interferon often causes serious adverse effects and the long-term goal entails the development of a completely interferon-free therapy. In October, Janssen acquired an NS5A replication complex inhibitor from GlaxoSmithKline. This NS5A replication complex inhibitor will be evaluated in combination with simeprevir for interferon-free treatment of genotype 1 chronic hepatitis C patients. A number of other interferon-free clinical studies with simeprevir are currently in progress and we presented good interim results from the COSMOS study, in which simeprevir is used in combination with sofosbuvir, with and without ribavirin.
Other R&D projects
In October, MIV-247 was selected as a candidate drug and has entered pre-clinical development for the treatment of neuropathic pain. The selection is an important milestone for our in-house cathepsin S project.
We also presented positive top-line results from the phase I study with the cathepsin K inhibitor, MIV-711, which is being developed for the treatment of osteoarthritis and other bone-related disorders. These study data are now being compiled and will be used for evaluation purposes in connection with potential future partnerships.
In the hepatitis C area, we decided to stop our research project with our internal NS5A replication complex inhibitors. The decision was taken on commercial grounds and means that we could then focus our hepatitis C research on novel nucleotide-based NS5B polymerase inhibitors.
The past quarter also saw the discontinuation of our collaboration with Daewoong regarding the development of MIV-210 for the treatment of hepatitis B. The decision was based on an evaluation of MIV-210 and its commercial potential in a hepatitis B market in which several pharmaceuticals will be available as generics within the next few years.
Medivir and Ferrer entered into an agreement during the quarter for the commercialisation of Adasuve in the Nordic market. Adasuve is a new treatment for agitation associated with schizophrenia and bipolar disorder. This agreement means that we now have 16 prescription pharmaceuticals in our product portfolio, which further strengthens our commercial position in the Nordic region.
On 10 October 2013, Medivir held a Capital Markets Day in Stockholm that included a wide-ranging presentation of Medivir’s operations and provided updates on all of the company’s significant projects.
I am looking forward with both excitement and confidence to the coming six months – a period in which simeprevir will be launched in Japan and, hopefully, also approved for sale in other markets.
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
Conference call for investors, analysts and the media
The Interim Report for the third quarter of 2013 will be presented by the CEO, Maris Hartmanis, and members of Medivir’s management group.
Time: Thursday, 21 November 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 +1 855 716 1589
The conference call will also be streamed via a link on the website, www.medivir.com
The Financial Statement for January-December will be published on 24 February 2014.
The Annual General Meeting will be held on 8 May 2014.