Saniona Ab · OMXSTO:SANION
Saniona Ab — Investor Presentation (May 2018)
24 slides from Saniona Ab's investor presentation, May 15, 2018
Slide 1: Med Sedemera på Aktietorget - til Nasdaq Smallcap på 4 år
May 15th, 2018 Med Sedemera på Aktietorget - til Nasdaq Smallcap på 4 år 1|
Slide 2: Saniona: Reduced risk – high upside potential
Saniona: Reduced risk – high upside potential Reduced risk Very broad pipeline Risk mitigated late stage programs Tesofensine obesity Many partnerships – generating early income/pays Tesomet PWS development costs Tesomet metabolic NS2359 addiction High upside potential Many shots on goal Late stage
Slide 3: Saniona's history - Saniona has delivered on strategy
Saniona’s history - Saniona has delivered on strategy Internal Partnered “Free ride” Value added programs programs programs Spin outs 2012 2013 6 research programs 2014 NS2359 Ph2 2015 Tesofensine 2016 Tesomet T2D Phase 2 Tesomet PWS 2017 Phase 2 Tesofensine SAN711 Phase 3 Preclinical NS2359 3| 2018
Slide 4: Strategic priorities
Strategic priorities To quickly develop and attain market 1. Tesomet in Prader Willi Syndrome approval for Tesomet internally in the U.S. and Europe in orphan indications To develop Tesomet in rest of the world 2. Tesomet in metabolic diseases through partnerships with pharmaceutical companies for m
Slide 5: PWS is a unique go-2-market opportunity
PWS is a unique go-2-market opportunity 1) Develop Tesomet internally in the U.S. and Europe in orphan indications 1. Large commercial opportunity Life threatening disease (acute and long term) Huge medical need Affect entire family and costly for society 2. Fast to market Patients easily to identif
Slide 6: Tesomet: Phase 2a Study in PWS For Potential Orphan Indication
Tesomet: Phase 2a Study in PWS For Potential Orphan Indication 1) Develop Tesomet internally in the U.S. and Europe in orphan indications Prader Willi syndrome Market opportunity in Prader Willi syndrom Incidence and prevalence 1 in 15,000 live births Prader Willi (consensus estimate by analysts) 15
Slide 7: Tesomet: Phase 2a Study In PWS For Potential Orphan Indication
Tesomet: Phase 2a Study In PWS For Potential Orphan Indication 1) Develop Tesomet internally in the U.S. and Europe in orphan indications Phase 2a study initiated in April 2017 PWS hyperphagia score and weight loss Exploratory randomized, double-blind, 14 placebo-controlled 12 weeks study in 9 12 pa
Slide 8: Craving… Obsession… Addiction
Craving… Obsession… Addiction Sanion: 3 unique products to control craving and addiction Tesomet Tesofensine NS2359 Eating Obesity Cocaine c.bader@c c.bader@c c.bader@c Disorders c.bader@c c.bader@c addiction c.bader@c fbcom.fr c.bader@c PWS fbcom.fr c.bader@c fbcom.fr c.bader@c fbcom.fr fbcom.fr fb
Slide 9: Craving Is Cause Of Three Out Of Four Largest Global Burdens
Craving Is Cause Of Three Out Of Four Largest Global Burdens 2) To develop Tesomet in ROW through partnerships for metabolic diseases 9|
Slide 10: Obesity Present a significant Health Challenge in Mexico
Obesity Present a significant Health Challenge in Mexico Mexico is experiencing an obesity epidemic with 38.8% of the population overweight and 32.4% obese 3 in 10 people worldwide are Mexico is the 2nd most obese In Mexico, 8 in 10 deaths are overweight or obese. In Mexico, the country in the world
Slide 11: Medix Collaboration
Medix Collaboration Medix is the market leader with half of the obesity market in Mexico Market Share by Top 10 Players 48.6% US$108mm sales By Sales 13.2% 13.2% (2016)1,2 7.4% 2.9% 2.9% 2.7% 1.8% 1.5% 1.4% Medix Collaboration Market size Medix finances clinical studies and The prescription medicine
Slide 12: Tesofensine: Medix Phase 3 Study in Mexico
Tesofensine: Medix Phase 3 Study in Mexico 3) Attain market approval for tesofensine in collaboration with Medix in Mexico and Argentina Phase 3 Study Methodology: Randomised, double-blind, placebo controlled trial in Mexico 372 patients enrolled: N=124: placebo N=124: 0.25mg tesofensine N=124: 0.50
Slide 13: Tesofensine: Phase 2 Study
Tesofensine: Phase 2 Study Robust, dose dependent weight loss over 24 weeks of treatment Study methodology Reduction in bodyweight compared to baseline Randomized, double-blind, placebo controlled trial in five Danish obesity management centers Enrolled 203 patients Energy restricted diet with
Slide 14: Tesofensine Could Double Weight Loss Compared To Competitors
Tesofensine Could Double Weight Loss Compared To Competitors Results at 48 weeks suggest tesofensine could be an alternative to surgery Reduction in bodyweight versus competing drugs* 16.0% 14.0% 14.0% Placebo controlled weight loss 12.0% 10.0% 9.2% 8.0% 6.6% 6.0% 6.0% 5.2% 4.0% 3.1% 2.4% 2.0% 0.0%
Slide 15: Validation of Tesomet concept
Validation of Tesomet concept Program de-risked through pre-clinical and clinical studies Extraordinary weight loss Tesofensine has shown unique appetite and body weight reducing efficacy in obese patients in a Phase 2 study superior to any single agent currently on the market and also a significant
Slide 16: Tesomet: Potential Blockbuster Drug With Orphan Drug Prospects
Tesomet: Potential Blockbuster Drug With Orphan Drug Prospects Mechanism of action creates multiple opportunities within metabolic diseases and eating disorders Potential “best-in-class” profile combining unmatched weight loss with a benign side effect profile for the treatment of weight related met
Slide 17: Obesity in ROW will be first target for Tesomet in metabolic field
Obesity in ROW will be first target for Tesomet in metabolic field 2) To develop Tesomet in ROW through partnerships with pharmaceutical companies for metabolic diseases With long development times in the U.S. and European markets, we expect to introduce Tesomet much earlier in Rest of World in the
Slide 18: Tesomet: Development And Partnering Strategy
Tesomet: Development And Partnering Strategy Develop Tesomet for eating disorders AND mature program for partnering in metabolic field 2018 2019 Prader Willi Syndrome Phase 2a/b Phase 2a eating disorder Go to market approach ✓ Tox on combination ✓ GMP Tablet Production Phase 2b obesity/metabolic ✓ T
Slide 19: Early Clinical and Preclinical Pipeline
Early Clinical and Preclinical Pipeline Strategic goal: Leverage research platform in partnerships and internally develop at least one candidate to Phase 2 Preclinical Preclinical Product/Target Indication Phase 1 Research Development Cadent Therapeutics Program Ataxia and tremor SAN711 Neuropathic
Slide 20: Financial position
Financial position Income statement MSEK 2017 2016 2015 2014 2013 2012 Acummulated Net sales 20,7 74,9 13,6 21,7 13,3 7,9 152,2 Operating expenses -77,9 -70,8 -41,7 -30,0 -15,0 -10,2 -245,5 Operating profit/loss -57,2 4,2 -28,1 -8,3 -1,7 -2,2 -93,3 Financial items 0,9 0,8 -1,2 0,5 -0,0 -0,0 1,0 Tax
Slide 21: Nice & Green convertible note financing of up to 144M SEK
Nice & Green convertible note financing of up to 144M SEK May cover planned activities until 2020 excluding lump sum payments from partners Nice & Green is a private Swiss company, which specializes in financing solutions tailored to the requirements of listed growth companies within the biotech and
Slide 22: Potential inflection points within the next 12 months
Potential inflection points within the next 12 months Not listed chronological Tesofensine: Top-line data from Phase 3 study in obesity and preparation of NDA filing in Mexico Tesomet: Completion of base package for Phase 2b and Phase 3 studies in eating disorders and metabolic diseases New activiti
Slide 23: Summary
Summaryary Clinical stage Phase 3 company 1 - Tesofensine in Phase 3 for obesity – Medix partnership - Tesomet in Phase 2a for PWS Go to market - NS2359 in Phase 2a for cocaine addiction – sponsored by grants - Preparation of Phase 2b for Tesomet in both metabolic diseases and eating disorders - CAD
Slide 24: Saniona AB, Baltorpvej 154, DK-2750 Ballerup
Saniona AB Baltorpvej 154 DK-2750 Ballerup Denmark Tel: +45 70705225 Web: saniona.com 24 |