Santhera Pharmaceuticals Holding AG · SIX:SANN
Santhera Pharmaceuticals — Investor Presentation (March 2012)
20 slides from Santhera Pharmaceuticals's investor presentation, Mar 1, 2012
Slide 1: A Swiss Specialty Pharmaceutical Company
A Swiss Specialty Pharmaceutical Company Company presentation March 1, 2012
Slide 2: Disclaimer
Disclaimer This presentation is not and under no circumstances to be construed as a solicitation, offer, or recommendation, to buy or sell securities issued by Santhera Pharmaceuticals Holding AG. Santhera Pharmaceuticals Holding AG makes no representation (either express or implied) that the inform
Slide 3: An Emerging Product Company
An Emerging Product Company Focus on innovative therapies in orphan / niche neuromuscular and mitochondrial diseases Catena® franchise with multiple opportunities in late-stage development – Marketed in Canada for the treatment of Friedreich’s Ataxia; Available in Europe (and other territories)
Slide 4: Corporate Information
Corporate Information Company presentation, March 1, 2012 4
Slide 5: Main Achievements in 2011
Main Achievements in 2011 Continued commercial success with Catena® in Canada and under Named Patient Program in Europe Marketing Authorization Application in LHON accepted for review by the European Medicines Agency Completion of restructuring and strategic focus on Catena® in several opportu
Slide 6: 2011 Key Financial Figures
2011 Key Financial Figures (IFRS, consolidated, in TCHF) 2011 2010 Net sales 3,265 3,496 Operating expenses –30,517 –29,694 Operating result –27,213 –8,711 Net result –27,838 –11,256 Net change in cash and cash equivalents –20,276 –9,638 Cash and cash equivalents 23,406 43,682 Stable net sales; No
Slide 7: Santhera Shares and Share Capital
Santhera Shares and Share Capital Market capitalization at year-end 2011: CHF 17.8m Ø daily trading volume in 2011: 5,082 shares (Registered) Shareholders by Domicile 1,600 shareholders; 70% of shares registered Largest shareholders control xx% of voting rights: Ares Life Sciences (CH) 14.9% NGN
Slide 8: Portfolio Overview: Focus on Catena and its Multiple Late-stage Opportunities
Portfolio Overview: Focus on Catena® and its Multiple Late-stage Opportunities Company presentation, March 1, 2012 8
Slide 9: Portfolio Focused on Orphan Neuromuscular & Mitochondrial Indications
Portfolio Focused on Orphan Neuromuscular & Mitochondrial Indications Preclinical Phase I Phase II Phase III Filing Market Catena® in Canada Friedreich’s Ataxia Catena® Leber’s Hereditary Optic Neuropathy Catena® / Sovrima® Duchenne Muscular Dystrophy Catena® MELAS Syndrome (IIT) Catena® Primary Pro
Slide 10: Catena in Friedreich's Ataxia: Generating Sales in Canada and Europe
Catena® in Friedreich’s Ataxia: Generating Sales in Canada and Europe Catena® approved by Health Canada for treatment of symptoms of Friedreich’s Ataxia Key learnings: Proven business model ‒ High medical need translated into fast uptake ‒ Premium-priced product ‒ Reimbursed by private and first
Slide 11: Catena in Leber's Hereditary Optic Neuropathy (LHON): Potentially First Therapy
Catena® in Leber’s Hereditary Optic Neuropathy (LHON): Potentially First Therapy Genetic disease caused by a degeneration of nerve cells in retina – Rapid loss of central vision, subsequent blindness – First symptoms in one eye, second eye involvement within a few months – Legal blindness in both
Slide 12: Data Consistency Across Different Analysis of Changes in Visual Acuity
Data Consistency Across Different Analysis of Changes in Visual Acuity (VA) P best recovery in VA 0.291 best VA 0.078 ITT population change in VA of best eye at BL 0.061 change of VA in both eyes 0.026 best recovery in VA 0.187 subgroup G11778A best VA 0.037 & G3460A change in VA of best eye at BL 0
Slide 13: Key Findings of RHODOS Study: Potential First Opportunity to Treat LHON
Key Findings of RHODOS Study: Potential First Opportunity to Treat LHON1 RHODOS study supports use of Catena® in treatment of LHON Protection of vision loss in patients at risk of vision loss Recovery of visual acuity in severely affected eyes (“off chart”) Robust results despite small sampl
Slide 14: Leveraging Catena into Duchenne Muscular Dystrophy
Leveraging Catena® into Duchenne Muscular Dystrophy Most common form of muscular dystrophy – Progressive muscle weakness, skeletal deformities – Affected motor skills – Respiratory failure, cardiac complications Caused by a deficiency of dystrophin Onset 3 to 5 years, life expectancy 35 to 40
Slide 15: Clinical Development Program in Duchenne Muscular Dystrophy
Clinical Development Program in Duchenne Muscular Dystrophy Proof of concept established in single-center DELPHI Phase IIa study ‒ Efficacy on cardiac and respiratory function ‒ 12-month treatment ‒ 21 boys, aged 8 to 16 years Pivotal DELOS Phase III study recruiting – 12-month treatment ‒ Curre
Slide 16: Friedreich's Ataxia (FA): First Indication for Catena/Sovrima
Friedreich’s Ataxia (FA): First Indication for Catena®/Sovrima® Severe genetic disorder – Degeneration of nerve and muscle tissue, loss of muscle control – Impaired movements, muscle wasting – Thickening of heart walls (cardiomyopathy) Caused by reduced level of frataxin, key energy protein in m
Slide 17: Upcoming News Flow
Upcoming News Flow Company presentation, March 1, 2012 17
Slide 18: Expected Milestones in 2012
Expected Milestones in 2012 Annual Shareholders’ Meeting (Basel, April 23) 1H 2012 Data of Phase IIa proof of concept study with Catena® in MELAS syndrome (MELTIMI study) 2012 Interim Report (August 31) 2H 2012 CHMP opinion on MAA in LHON Data of 2-year open-label extension study with Cate
Slide 19: Company presentation dates
Company FY 2008 Results, presentation, February September July March 27, 1, 1, 2009 2009 2012 2010 19
Slide 20: Contacts
Contacts Santhera Pharmaceuticals Holding AG Hammerstrasse 49 CH-4410 Liestal Switzerland www.santhera.com Thomas Meier, Chief Executive Officer Phone +41 (0)61 906 89 64 [email protected] Thomas Staffelbach, VP, Head Public & Investor Relations Phone +41 (0)61 906 89 47 thomas.staffelbach@s
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