Jefferies Health Care Seminar New York, June 3, Maris Hartmanis President & CEO

Transcription

1 Jefferies Health Care Seminar New York, June 3, 2014 Maris Hartmanis President & CEO

2 2 Medivir The emerging European pharma company Headquartered and listed in Stockholm, Sweden ~ 140 employees, of which 90 are in R&D World leading expertise in polymerase and protease drug targets R&D pipeline: 3 major internally driven projects Nordic commercial organization marketing 16 Rx pharmaceuticals Two innovative specialty care products, Olysio and Adasuve recently launched in the Nordics Two pharmaceuticals taken from idea to market: - Olysio (simeprevir) for treatment of chronic hepatitis C, licensed to J&J globally excluding the Nordics - Xerclear for treatment of labial herpes, licensed to GSK in Europe

3 Financial facts Listed on NASDAQ OMX Stockholm since 1996 Broad institutional shareholder base, >20% EU & US shareholders Solid financial position (342 MSEK end Q1, 14*), on the way to sustainable profitability Sales in 2013 were 176 MSEK (~27 MUSD) CONSOLIDATED INCOME STATEMENT SUMMARY Q1 Q1 FY Continuing operations (MSEK) Net turnover Gross profit EBITDA EBIT Profit/loss before tax Profit/loss after tax Market Capitalization: 4,000 MSEK 615MUSD Cash (March 31)*: 342 MSEK 53 MUSD Debt (March 31): 42MSEK 6 MUSD Revenues Q1, 14: 46 MSEK 7 MUSD Net burn rate: 240 MSEK 37 MUSD Shares Outstanding: Class B: 30,600,027 Class A: 660,000 Options: 404,374 Fully Diluted: 31,664,401 *Q1 simeprevir royalties of 161 MSEK not accounted for in cash position. Including the royalties,the end Q1 cash position was 500 MSEK (77 MUSD) 3

4 Strategic direction R&D Operations Commercial Operations Development of R&D platform Build value by three major internally driven projects Evaluate new therapeutic areas based on protease and polymerase core competence Creation of new partnerships/collaborations Continue to develop R&D assets via partnerships Commercial expansion Add new pharmaceuticals for the Nordic market Launch Olysio (simeprevir) in the Nordic market Develop business and therapy scope further 4

5 MIV-711: A cathepsin K inhibitor in clinical development for osteoarthritis (OA) Osteoarthritis A chronic progressive disease characterized by excessive bone resorption and cartilage degradation leading to pain and disability Medical need Affecting 10-15% of the US population and more than 80 million in the US, Europe and Japan* MIV-711 mechanism of action Inhibits cathepsin K, which degrades both bone and cartilage collagen Two abstracts with MIV-711 data presented at the OA conference, Paris (April -14): I. Non-clinical: Once daily MIV-711 reverses subchondral bone loss in an experimental model of OA II. Clinical: 28 day treatment of post meno-pausal women (100 mg, OD) reduced urinary biomarkers for bone resorption and cartilage degradation with up to 98% and 55%, respectively MIV preparing for clinical phase II and partnership *Datamonitor,

6 MIV-247: A cathepsin S inhibitor for neuropathic pain Neuropathic pain Associated with a lesion or disease affecting the somatosensory system Includes e.g. diabetic neuropathic pain, post-herpetic neuralgia and neuropathic lower back pain Medical need Current treatments incl. anticonvulsants and antidepressants - Pain persists in 75% patients with at best a 50% reduction in overall pain - Significant side effects e.g. dizziness, somnolence MIV-247 candidate drug Results from non-clinical in vivo studies support the development of MIV-247: - as monotherapy (fast and sustained efficacy seen in models of neuropathic pain) - as combination therapy (improved efficacy shown when combined with e.g. gabapentin) MIV preparing for clinical phase development in H1,

7 Own unpartnered HCV nucleotide program moving towards selection of clinical candidate (CD) Medivir has leveraged its extensive nucleotide experience to pursue high value nucleotide compounds Current effort is focused on novel uridinebased series Medivir s compounds are structurally distinct from existing nucleoside starting points Initial protide series features include: EC 50 values of <100nM against HCV genotype 1-6 High in vitro selectivity indices Attractive early pharmacokinetic profile 7

8 Growth by adding innovative specialty care products to existing pharmaceutical portfolio Commercial Operations Etc. x (Medivir) Inlicencing partners In-licensed 5 In-licensed 4 In-licensed 3 In-licensed 2 Olysio (Medivir) Adasuve (in-licensed) Medivir R&D + partners Launched In 2014 Innovative specialty care pharmaceuticals, in areas like: - Infectious disease - Psychiatry - Oncology 16 marketed Rx pharmaceuticals Nordic brands Existing pharmaceuticals 8 Potential future pharmaceuticals

9 Simeprevir on the market Japan (SOVRIAD ) Canada (GALEXOS ) USA (OLYSIO )* Russia (SOVRIAD ) EU (OLYSIO ) * A supplemental New Drug Application has been submitted to the U.S. FDA for Olysio (simeprevir) in combination with Sovaldi (sofosbuvir) based on data from the COSMOS trial 9

10 Simeprevir a strong market uptake After launch in December sales have grown rapidly, currently ~20% market share in the US The global Q1 net sales were 354 MUSD, of which 291 MUSD in the US Medivir s Q1 royalty was 161 MSEK (18 MEUR) Simeprevir is now approved in the US, Canada, Japan, Russia and Europe Two phase III studies evaluating treatment of hepatitis C-infected patients with simeprevir and sofosbuvir initiated, based on the outcome from the COSMOS trial A supplemental NDA submitted to FDA for once-daily use of simeprevir in combination with sofosbuvir 10

11 EASL: Final COSMOS data Cohort 1: Prior null responders (METAVIR F0-F2) Cohort 2: naïves and nulls (METAVIR F3/4) No benefit demonstrated by addition of ribavirin High SVR12 rates regardless of baseline characteristics (HCV GT 1 subtype, Q80K polymorphism, METAVIR score, IL28B GT or prior treatment history) SMV/SOF QD +/- RBV was safe and well tolerated High SVR12 rates, 93-96%, with 12 weeks once daily treatment with simeprevir + sofosbuvir in hard to cure patients SMV: simeprevir; SOF: sofosbuvir; RBV: ribavirin 11

12 Ongoing IFN-free studies with simeprevir to explore interferon-free combinations Class Compound Partner Status PI Nuc Simeprevir Sofosbuvir Janssen OPTIMIST 1: null + naives (F0-3), 8 or 12 weeks (n=300) OPTIMIST 2: null + naïves (F4), 12 weeks duration (n=100) - no ribavirin in either study PI NS5A Simeprevir IDX719 Janssen Idenix Simeprevir JNJ Janssen Phase II on its way HELIX-1: Phase II, Gt1b and 4 (150 mg SMV + 50 mg SAM + RBV-> 85% SVR4) PI NS5A NNI Simeprevir IDX719 TMC055 Simeprevir JNJ TMC055 Janssen Idenix Janssen Janssen HELIX-2: Phase II started Dec-13 (Genotype1) Phase II started Dec-13 Other on-going studies IFN and RBV containing: 12 weeks full stop single-arm phase III study in treatment naïve GT1 and GT4 patients China: efficacy, safety & tolerability and pharmacokinetics in treatment naive GT1 HCV patients (phase III results available by year end) IFN: interferon; Nuc: nucleotide polymerase inhibitor; NNI: non-nucleoside polymerase inhibitor; NS5A: NS5A replication complex inhibitor; PI: protease inhibitor 12

13 2014: A solid platform for continued development of the company Moving towards sustainable profitability, with simeprevir being the most important driver Simeprevir had ~50% market share in Japan and ~20% market share in the US end of Q1, 14 and is part of the only IFN-free regimen currently in use based on Jan guidelines Our Nordic organization has recently launched two new pharmaceuticals, Olysio (simeprevir) and Adasuve Our R&D pipeline has three major internally driven projects, which all are advancing and will enable new partnerships/joint ventures This will enable us to focus on further value creation and risk diversification 13

14 Ticker: MVIR Exchange: OMX / NASDAQ For more information please contact Rein Piir, EVP Corporate Affairs & IR (rein.piir@medivir.com) 14