May 15th, 2018 Med Sedemera på Aktietorget - til Nasdaq Smallcap på 4 år 1 |
Saniona: Reduced risk – high upside potential Reduced risk Very broad pipeline Tesofensine obesity Risk mitigated late stage programs Many partnerships – generating early income/pays Tesomet PWS development costs Tesomet metabolic NS2359 addiction High upside potential Many shots on goal Late stage pipeline with potential first product in 2020 Addressing huge markets opportunities With ”first in class” products In orphan drug space Potential for own commercialisation MSEK 2017 2016 Short studies - Orphan drug status possible Revenues 21 75 Expenses -78 -71 Operating profit -57 4 With demonstrated execution power Experienced management: executed many deals and Total assets 48 71 development programs Cash 22 53 Equity 38 54 World-class research team focused on ion channels with 25+ years of experience Financing secured until 2020 2 |
Saniona’s history - Saniona has delivered on strategy Partnered Value added Internal “Free ride” programs Spin outs programs programs 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 2018 CAD-1883 interim 3 | 3 | Phase 1
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 through partnerships with pharmaceutical 2. Tesomet in metabolic diseases companies for metabolic diseases To quickly attain market approval for tesofensine in collaboration with Medix in Market 2020? 3. Tesofensine in obesity in Mexico Mexico and Argentina 4 |
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 identify Clear endpoints with short studies Orphan drug status possible 3. Low investment Relative short and small clinical trials Commercial set-up manageable 5 |
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) 15-20,000 in the U.S. and Europe combined No FDA-approved treatment for PWS Analyst Market opportunity: 15-20,000 patients @ 80- Medical need 150,000 USD Acute life threating hyperphagia (choking, bowel rupture) Estimated revenue of $1B ($650M U.S. and $350M EU) Life-threatening obesity (diabetes, cardio-vascular, sudden death) Hypothalamic obesity (consensus estimate by analysts) Short life expectation (average in 30’ties) A non genetic disease with similar symptoms in terms of No effective treatment available today hyperphagia and obesity Economic and social costs Quality of life for patients and families Analyst Market opportunity: 10-15,000 patients @ 80-150,000 USD Family stress Leerink (2014, Zafgen beloranib estimate): ~$220MM Loss of income Care and medical costs (USD 100-300K per year) in peak adjusted sales in 2029 Growth hormones etc. SunTrust (2014, Zafgen beloranib estimate): Assisted living ~$250MM in peak adjusted sales in 2025 Complication of hyperphagia and obesity 6 |
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 14 Exploratory randomized, double-blind, placebo-controlled 12 weeks study in 9 12 patients 10 Tesomet 6; Placebo 3 8 Tesomet Positive effect on key efficacy endpoints 6 Placebo Reduced craving for food 4 Weight loss 2 Higher than expected plasma levels indicates 0 that lower doses should be used in PWS Visit 1 Visit 2 Visit 5 Visit 9 Visit 14 patients Weight loss Week 8 Week 13 Tesomet 5.00 % (n=5) 6.75 % (n=2) Placebo 0.46 % (n=2) 0.75 % (n=2) April 2018 approval for next step: second part of PWS protocol in adolescents 7 |
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 fbcom.fr fbcom.fr c.bader@c c.bader@c c.bader@c PWS fbcom.fr fbcom.fr fbcom.fr fbcom.fr fbcom.fr fbcom.fr Food: sugar, fat, chocolate… Alcohol Tobacco/nicotine Drugs: cocaine, opiates… Ph2 Ph3 Ph2 Gaming, Ludomania “Go to market” “Royalty Mexico” “Go to market” Social media “mania” 8 |
Craving Is Cause Of Three Out Of Four Largest Global Burdens 2) To develop Tesomet in ROW through partnerships for metabolic diseases 9 |
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 Mexico is the 2 nd most obese In Mexico, 8 in 10 deaths are 3 in 10 people worldwide are caused by chronic, non- overweight or obese. In Mexico, the country in the world after US; transmitted diseases linked to the population is on avg. 2x+ as Mexican women and children are overweight and obese population overweight or obese (7 in 10) the most obese worldwide Significant Unmet Need in Mexico (18.50 – 24.99) Normal Range 129 million BMI Total Population 90.3 million overweight and Body Mass Index 1 (≥ 25.00– 29.99) Classification obese Overweight Addressable Market BMI 2.9 million 2 Diagnosed by Physician (≥ 30.00) Obese BMI 1.1 million 2 Treated with Rx 10 |
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 13.2% (2016) 1,2 13.2% By Sales 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 market for obesity in commercialization Mexico is around USD 250 million Saniona receives double digit royalties in Mexico Stage of development and Argentina. Phase 3 to be completed in 2018 Saniona retains rights to rest of the world 11 |
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: 0.50mg tesofensine 24 weeks treatment period and a 12 week follow up All patients prescribed an energy restricted diet of 1,500-2,000 kcal and physical activity of 20-40 minutes Endpoints: Primary endpoint: percent change in bodyweight compared to baseline at 24 weeks Secondary endpoints include: Proportions of patients achieving a weight loss of >5 and 10 percent, respectively Metabolic including glycaemic endpoints Quality of life 12 |
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 a daily energy deficit of 300kcal in addition to physical activity of 30- 60 minutes Primary endpoint: percentage change in 2.0% average reduction bodyweight compared to baseline at 24 weeks Results & follow up Adverse effects similar to placebo with an 6.5% average reduction increase in heart rate compared to baseline Open label study conducted to follow patients for an additional 24 weeks after the Phase 2b trial. At 48 weeks patients had lost 14-15% in 11.2% average reduction bodyweight compared to baseline. Results at 48 weeks suggest tesofensine could be 12.6% average reduction competitive to surgery which usually result in 15- 20% reduction in bodyweight 13 | *Results from competing drugs taken from their respective studies and have been adjusted for their respective placebo results. Results from competing trials are not directly comparable.
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% Xenical Belvig Contrave Victoza Osymnia Tesofensine Tesofensine 3x120mg 2x10mg 2x360/32mg 3mg 7.5/46mg 0.5mg 0.5mg 4 years 1 year 56 weeks 56 weeks 56 weeks 24 weeks 48 weeks open label 14 | *Results from competing drugs taken from their respective studies and have been adjusted for their respective placebo results. Results from competing trials are not directly comparable.
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