jefferies health care seminar new york, june 3, 2014 … health care seminar new york, june 3, 2014...
TRANSCRIPT
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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
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)
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
Financial facts
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CONSOLIDATED INCOME
STATEMENT SUMMARY Q1 Q1 FY
Continuing operations
(MSEK) 2014 2013 2013
Net turnover 208.2 178.1 446.1
Gross profit 182.1 160.2 374.3
EBITDA 96.7 90.5 76.4
EBIT 88.6 76.7 25.2
Profit/loss before tax 90.3 76.6 27.7
Profit/loss after tax 283.8 71.1 16.0
*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)
Strategic direction
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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
MIV-711: A cathepsin K inhibitor in clinical development for osteoarthritis (OA)
MIV-711 - preparing for clinical phase II and partnership
Osteoarthritis
• A chronic progressive disease characterized by excessive bone resorption and cartilage degradation leading to pain and disability
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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
*Datamonitor, 2009
MIV-711 – mechanism of action
• Inhibits cathepsin K, which degrades both bone and cartilage collagen
Medical need • Affecting 10-15% of the US population and
more than 80 million in the US, Europe and Japan*
MIV-247: A cathepsin S inhibitor for neuropathic pain
MIV-247 - preparing for clinical phase development in H1, 2015
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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)
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
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
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 uridine-based series
Medivir’s compounds are structurally distinct from existing nucleoside starting points
Initial protide series features include: – EC50 values of <100nM against HCV genotype 1-6 – High in vitro selectivity indices – Attractive early pharmacokinetic profile
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Etc.
x (Medivir)
In-licensed 5
In-licensed 4
In-licensed 3
In-licensed 2
Olysio (Medivir)
Adasuve (in-licensed)
16 marketed Rx pharmaceuticals
Growth by adding innovative specialty care products to existing pharmaceutical portfolio
Nordic brands
Innovative specialty care pharmaceuticals, in areas like: - Infectious disease - Psychiatry - Oncology
Medivir R&D +
partners
In-licencing partners
Potential future pharmaceuticals Existing pharmaceuticals
Launched In 2014
Commercial Operations
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
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Simeprevir on the market
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
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EASL: Final COSMOS data
SMV: simeprevir; SOF: sofosbuvir; RBV: ribavirin
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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
Ongoing IFN-free studies with simeprevir to explore interferon-free combinations
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Class
Compound Partner Status
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
Simeprevir IDX719
Janssen Idenix
HELIX-1: Phase II , Gt1b and 4 (150 mg SMV + 50 mg SAM + RBV-> 85% SVR4)
Simeprevir JNJ-56914845 Janssen Phase II on its way
Simeprevir IDX719 TMC055
Janssen Idenix
Janssen HELIX-2: Phase II started Dec-13 (Genotype1)
Simeprevir JNJ-56914845 TMC055
Janssen Phase II started Dec-13
IFN: interferon; Nuc: nucleotide polymerase inhibitor; NNI: non-nucleoside polymerase inhibitor; NS5A: NS5A replication complex inhibitor; PI: protease inhibitor
Nuc PI
NS5A PI
NS5A PI NNI
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)
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. 2014 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
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www.medivir.com
Ticker: MVIR
Exchange: OMX / NASDAQ
For more information please contact
Rein Piir, EVP Corporate Affairs & IR
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