Medivir Ab · OMXSTO:MVIR
Medivir Ab — Q1 2014 Earnings Presentation
20 slides from Medivir Ab's earnings presentation, May 8, 2014
Slide 1: Q1-2014 Conference Call
Q1-2014 Conference Call 8 May 2014 Presenting team Maris Hartmanis, President and CEO Charlotte Edenius, EVP Development Richard Bethell, EVP Discovery Research Rein Piir, EVP Corporate Affairs & IR
Slide 2: Reflections on first quarter 2014
Reflections on first quarter 2014 Maris Hartmanis, CEO 2
Slide 3: First quarter 2014 – things are on track and moving
First quarter 2014 – things are on track and moving Our pharmaceuticals o Our pharmaceutical portfolio comprises 16 prescription pharmaceuticals that are marketed in the Nordic region, where we in the future will have a strong focus on specialty pharmaceuticals in the growth phase. o During the firs
Slide 4: Consolidated income statement
Consolidated income statement 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
Slide 5: Net turnover breakdown
Net turnover breakdown Net turnover breakdown Q1 Q1 FY (MSEK) 2014 2013 2013 Outlicensing and partnership agreements: - 126.8 258.5 Non-recurrent payments Pharmaceutical sales 46.4 51.3 176.1 Royalties 161.7 - 11.5 Other services - - - Total 208.1 178.1 446.1 5
Slide 6: Net turnover continuing operations per quarter, MSEK
Net turnover continuing operations per quarter, MSEK 250 200 150 100 50 0 Q4-13 Q1-14 Royalty Milestones, Up front & Outlicensing revenues Pharmaceuticals sales revenues 6
Slide 7: Net turnover continuing operations per quarter, MSEK
Net turnover continuing operations per quarter, MSEK 180 160 140 120 100 80 60 40 20 0 Q2-12 Q3-12 Q4-12 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Pharmaseutical sales revenues Milestones, Up front & Outlicensing revenues Royalty 7
Slide 8: 2014 – our momentum is strong
2014 – our momentum is strong o Moving towards sustainable profitability, simeprevir being a important component. o Simeprevir is selling well – part of the only IFN-free regimen currently in use based on recent guidelines from January 2014. o During the first quarter simeprevir had a ~50% market sh
Slide 9: Simeprevir
Simeprevir o After the launch in December, simeprevir sales have grown rapidly: ~20% market share in the US currently. o The global first quarter net sales of simeprevir were 354 MUSD, of which 291 MUSD were sales in the US. o Medivir’s royalties based on these sales were 161 MSEK (18 MEUR) for the
Slide 10: Development Highlights Q1 2014
Development Highlights Q1 2014 Charlotte Edenius, EVP Development 10
Slide 11: MIV-711 - a cathepsin K inhibitor for osteoarthritis
MIV-711 - a cathepsin K inhibitor in clinical development for osteoarthritis (OA) Osteoarthritis Two abstracts with MIV-711 data presented at the OA conference, Paris (April 24-29): • A chronic progressive disease characterized by excessive bone resorption and cartilage • Non-clinical: novel results
Slide 12: MIV-247 – a cathepsin S inhibitor for neuropathic pain
MIV-247 – a cathepsin S inhibitor for neuropathic pain Neuropathic pain Mechanism of action • Associated with a lesion or disease affecting • Cathepsin S is a validated target in a broad the somatosensory system range of preclinical models of pain • Includes e.g. diabetic neuropathic pain, post- • I
Slide 13: Simeprevir on the market
Simeprevir on the market Japan (SOVRIAD™) Canada (GALEXOS™) USA (OLYSIO™)* Russia (SOVRIAD™) EU: Positive recommendation from CHMP, approval expected in May * A supplemental New Drug Application has been submitted to the U.S. FDA for simeprevir in combination with sofosbuvir based on the d
Slide 14: Simeprevir - ongoing and recently presented studies with PegIFN/ribavirin combination
Simeprevir - ongoing and recently presented studies with PegIFN/ribavirin combination APASL (Brisbane, Feb) • ATTAIN study (simeprevir vs telaprevir, prior null or partial responder patients (N=744)) – Simeprevir demonstrated non-inferiority while having a superior safety profile (lower adverse even
Slide 15: COSMOS study – IFN-free combination of simeprevir and sofosbuvir
COSMOS study – an IFN-free combination study of simeprevir and sofosbuvir in hard-to-cure patients Arm 1 SMV + SOF + RBV Post-treatment follow-up Arm 2 SMV + SOF Post-treatment follow-up Arm 3 SMV+SOF+RBV Post-treatment follow-up Arm 4 SMV + SOF Post-treatment follow-up Weeks 0 12 24 36 48 SMV 150 m
Slide 16: EASL: COSMOS – final data
EASL: COSMOS – final 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
Slide 17: EASL: COSMOS Cohort 2 final data
EASL: COSMOS Cohort 2 final data SVR12 among patient subgroups with advanced liver disease (METAVIR scores F3-F4) 12 weeks treatment SMV/SOF SMV/SOF + Rbv SVR12 % (n/N) % (n/N) All patients 93 (13/14) 93 (25/27) HCV GT1a without the 88 (7/8) 93 (13/14) Q80K polymorphism HCV GT1a with the Q80K 100 (3
Slide 18: Ongoing IFN-free studies with simeprevir
Ongoing IFN-free studies with simeprevir - data driven approach to exploring different interferon-free combinations Class Compound Partner Status OPTIMIST 1: null + naives (F0-3), 8 or 12 weeks (n=300) Simeprevir Janssen PI Nuc OPTIMIST 2: null + naïve s (F4), 12 weeks duration (n=100) Sofosbuvir -
Slide 19: Q/A
'MEDIVIR Q/A
Slide 20: www.medivir.com
www.medivir.com Ticker: MVIR Exchange: OMX / NASDAQ For more information please contact Rein Piir, EVP Corporate Affairs & IR ([email protected]) 20