Med Sedemera p Aktietorget - til Nasdaq Smallcap p 4 r 1 | Saniona: - - PowerPoint PPT Presentation

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Med Sedemera på Aktietorget

• til Nasdaq Smallcap på 4 år

May 15th, 2018

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Saniona: Reduced risk – high upside potential

Reduced risk Very broad pipeline Risk mitigated late stage programs Many partnerships – generating early income/pays development costs 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 Short studies - Orphan drug status possible With demonstrated execution power Experienced management: executed many deals and development programs World-class research team focused on ion channels with 25+ years of experience Tesofensine obesity Tesomet PWS Tesomet metabolic NS2359 addiction

MSEK 2017 2016 Revenues 21 75 Expenses

• 78
• 71

Operating profit

• 57

4 Total assets 48 71 Cash 22 53 Equity 38 54

Financing secured until 2020

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Internal programs

2012 2013 2014 2015 2016 2017

Tesomet T2D Phase 2 Tesomet PWS Phase 2 SAN711 Preclinical 6 research programs NS2359 Ph2

Value added Spin outs Partnered programs “Free ride” programs

2018

NS2359 interim

Saniona’s history - Saniona has delivered on strategy

Tesofensine Tesofensine Phase 3 CAD-1883 Phase 1

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Strategic priorities

• 1. Tesomet in Prader Willi Syndrome

To quickly develop and attain market 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 companies for metabolic diseases To quickly attain market approval for tesofensine in collaboration with Medix in Mexico and Argentina

• 2. Tesomet in metabolic diseases
• 3. Tesofensine in obesity in Mexico

Market 2020?

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PWS is a unique go-2-market opportunity

• 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 1) Develop Tesomet internally in the U.S. and Europe in orphan indications

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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 Incidence and prevalence 1 in 15,000 live births 15-20,000 in the U.S. and Europe combined Medical need Acute life threating hyperphagia (choking, bowel rupture) Life-threatening obesity (diabetes, cardio-vascular, sudden death) Short life expectation (average in 30’ties) No effective treatment available today Economic and social costs Quality of life for patients and families Family stress Loss of income Care and medical costs (USD 100-300K per year) Growth hormones etc. Assisted living Complication of hyperphagia and obesity Market opportunity in Prader Willi syndrom Prader Willi (consensus estimate by analysts) No FDA-approved treatment for PWS Analyst Market opportunity: 15-20,000 patients @ 80- 150,000 USD Estimated revenue of $1B ($650M U.S. and $350M EU) Hypothalamic obesity (consensus estimate by analysts) A non genetic disease with similar symptoms in terms of hyperphagia and obesity Analyst Market opportunity: 10-15,000 patients @ 80-150,000 USD Leerink (2014, Zafgen beloranib estimate): ~$220MM in peak adjusted sales in 2029 SunTrust (2014, Zafgen beloranib estimate): ~$250MM in peak adjusted sales in 2025

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Tesomet: Phase 2a Study In PWS For Potential Orphan Indication

Weight loss Week 8 Week 13 Tesomet 5.00 % (n=5) 6.75 % (n=2) Placebo 0.46 % (n=2) 0.75 % (n=2)

1) Develop Tesomet internally in the U.S. and Europe in orphan indications

Phase 2a study initiated in April 2017

Exploratory randomized, double-blind, placebo-controlled 12 weeks study in 9 patients Tesomet 6; Placebo 3 Positive effect on key efficacy endpoints Reduced craving for food Weight loss Higher than expected plasma levels indicates that lower doses should be used in PWS patients

April 2018 approval for next step: second part of PWS protocol in adolescents

PWS hyperphagia score and weight loss

2 4 6 8 10 12 14 Visit 1 Visit 2 Visit 5 Visit 9 Visit 14 Tesomet Placebo

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Craving… Obsession… Addiction

Food: sugar, fat, chocolate… Alcohol Tobacco/nicotine Drugs: cocaine, opiates… Gaming, Ludomania Social media “mania”

c.bader@c fbcom.fr c.bader@c fbcom.fr c.bader@c fbcom.fr Tesomet

Eating Disorders PWS

Ph2 Ph3 c.bader@c fbcom.fr c.bader@c fbcom.fr c.bader@c fbcom.fr Tesofensine

Obesity

Ph2 c.bader@c fbcom.fr c.bader@c fbcom.fr c.bader@c fbcom.fr NS2359

Cocaine addiction

“Go to market” “Royalty Mexico” “Go to market”

Sanion: 3 unique products to control craving and addiction

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Craving Is Cause Of Three Out Of Four Largest Global Burdens

2) To develop Tesomet in ROW through partnerships for metabolic diseases

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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 2nd most obese country in the world after US; Mexican women and children are the most obese worldwide In Mexico, 8 in 10 deaths are caused by chronic, non- transmitted diseases linked to the

• verweight and obese population

3 in 10 people worldwide are

• verweight or obese. In Mexico, the

population is on avg. 2x+ as

• verweight or obese (7 in 10)

Significant Unmet Need in Mexico 129 million Total Population 90.3 million overweight and

• bese

Addressable Market 2.9 million2 Diagnosed by Physician 1.1 million2 Treated with Rx

Normal Range BMI (18.50 – 24.99) Overweight BMI (≥ 25.00– 29.99) Obese BMI (≥ 30.00)

Body Mass Index1 Classification

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Medix Collaboration

Medix Collaboration

Medix finances clinical studies and commercialization Saniona receives double digit royalties in Mexico and Argentina. Saniona retains rights to rest of the world

Medix is the market leader with half of the obesity market in Mexico

Market Share by Top 10 Players

48.6% 13.2% 13.2% 7.4% 2.9% 2.9% 2.7% 1.8% 1.5% 1.4% US$108mm sales (2016)1,2

By Sales

Market size

The prescription medicine market for obesity in Mexico is around USD 250 million

Stage of development

Phase 3 to be completed in 2018

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Tesofensine: Medix Phase 3 Study in Mexico

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

3) Attain market approval for tesofensine in collaboration with Medix in Mexico and Argentina

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Tesofensine: Phase 2 Study

Robust, dose dependent weight loss over 24 weeks of treatment

Results & follow up

 Adverse effects similar to placebo with an

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

bodyweight compared to baseline.

 Results at 48 weeks suggest tesofensine could be

competitive to surgery which usually result in 15- 20% reduction in bodyweight

Reduction in bodyweight compared to baseline

*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.

 Randomized, double-blind, placebo controlled

trial in five Danish obesity management centers

 Enrolled 203 patients  Energy restricted diet with a daily energy deficit

• f 300kcal in addition to physical activity of 30-

60 minutes

 Primary endpoint: percentage change in

bodyweight compared to baseline at 24 weeks

Study methodology

2.0% average reduction 6.5% average reduction 11.2% average reduction 12.6% average reduction

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Tesofensine Could Double Weight Loss Compared To Competitors

Results at 48 weeks suggest tesofensine could be an alternative to surgery

*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.

2.4% 3.1% 5.2% 6.0% 6.6% 9.2% 14.0% 0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 12.0% 14.0% 16.0% Xenical 3x120mg 4 years Belvig 2x10mg 1 year Contrave 2x360/32mg 56 weeks Victoza 3mg 56 weeks Osymnia 7.5/46mg 56 weeks Tesofensine 0.5mg 24 weeks Tesofensine 0.5mg 48 weeks

• pen label

Placebo controlled weight loss

Reduction in bodyweight versus competing drugs*

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Validation of Tesomet concept

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 reduction of several glycaemic parameters in the pre-diabetic subgroup. Full tox package and well tolerated in humans Full tox package on tesofensine including carcinogenicity is available Tesofensine has been dosed to ~ 1700 healthy volunteers and patients with no unexpected side effects Adverse effect at therapeutic doses similar to placebo However, an increase in heart rate is seen (driven by noradrenaline beta-activity). Combination with metoprolol blunts heart rate increase, but maintains weight loss The combination of tesofensine and metoprolol has in an animal study shown the desired cardiovascular safety profile without any loss in weight reducing efficacy The combination of tesofensine and metoprolol showed no clinically relevant drug-drug interaction in a Phase 1 DDI study and a single dose of metoprolol mitigated the tesofensine-induced increase in heart rate. Validation of Tesomet concept in Ph2 Study in T2D: Weight loss efficacy with favourable cardiovascular profile (HR and BP reduced) New IP estate Recently filed applications on Tesomet product should provide protection until 2036.

Program de-risked through pre-clinical and clinical studies

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Tesomet: Potential Blockbuster Drug With Orphan Drug Prospects

TESOFENSINE METOPROLOL

Effective weight loss drug Beta blocker to control increased heart rate

Potential “best-in-class” profile combining unmatched weight loss with a benign side effect profile for the treatment of weight related metabolic diseases

COMPOSITION INDICATIONS

EATING DISORDERS

Prader Willi Syndrome

• US/EU Prevalence: ~ 20,000

Hypothalamic obesity (e.g after brain surgery)

• US/EU Prevalence: ~ 15,000

Binge eating

• WW Prevalence: ~2.8 million

METABOLIC DISEASE

Obesity

• WW Prevalence: ~500 million

Type 2 diabetes

• WW Prevalence: ~370 million

Fatty liver (NASH)

• WW Prevalence: +10 million

Mechanism of action creates multiple opportunities within metabolic diseases and eating disorders

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Obesity in ROW will be first target for Tesomet in metabolic field

With long development times in the U.S. and European markets, we expect to introduce Tesomet much earlier in Rest of World in the metabolic field

• 1. Commercial

Obesity is a world-wide problem We have already a partner in Mexico, which intends to develop Tesomet

• 2. Fast to market

Shorter and smaller Phase 3 studies (e.g. 6 months with a few hundred patients versus 12 months and thousands of patients)

• 3. No cannibalisation on eating disorders

Orphan drug and high prices niche indications does not exist in these territories 2) To develop Tesomet in ROW through partnerships with pharmaceutical companies for metabolic diseases

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Tesomet: Development And Partnering Strategy

Develop Tesomet for eating disorders AND mature program for partnering in metabolic field

2018

✓ Tox on combination ✓ GMP Tablet Production ✓ Test of tablet (Ph1) ✓ Validation of dose ratio (Ph1)

2019

Prader Willi Syndrome Phase 2a Phase 2b obesity/metabolic Partner approach Phase 2a/b eating disorder Go to market approach

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 Research collaborations create long term value as projects develop to clinical stage  Research collaborations also provide funding for internal activities until market approval

• Operational costs
• Investments in internal pipeline

Early Clinical and Preclinical Pipeline

Strategic goal: Leverage research platform in partnerships and internally develop at least one candidate to Phase 2

Product/Target Indication Preclinical Research Preclinical Development Phase 1 Cadent Therapeutics Program Ataxia and tremor SAN711 Neuropathic pain & Itching Boehringer Ingelheim Program Schizophrenia IK Program Inflamation, IBD Benevolent Program Neurological Disorders Niccotine α6 Program Parkinsons Disease

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Financial position

Conversion rate: 0.123583 SEK to 1 USD

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 on net profit 7,1

• 2,7

6,3 1,8 0,4 0,6 13,5 Profit/loss

• 49,2

2,2

• 22,9
• 5,9
• 1,3
• 1,7
• 78,8

Other comprehensive income

• 1,0
• 1,1

0,3 0,0

• 0,1

0,0

• 1,8

Total comprehensive income

• 50,2

1,1

• 22,6
• 5,9
• 1,4
• 1,7
• 80,6

Balance sheet

MSEK Dec-17 Dec-16 Dec-15 Dec-14 Dec-13 Dec-12 Non-current assets 7,8 2,7 2,3 2,1 2,0 0,1 Current receivables 18,3 14,8 8,4 3,7 1,1 0,8 Cash and cash equivalent 22,3 53,3 47,0 9,7 0,9 7,2 Total assets 48,4 70,8 57,7 15,5 4,0 8,0 Equity 37,6 54,3 52,9 8,8 -2,9 -1,5 Total liabilities 10,7 16,5 4,7 6,7 6,9 9,6 Total equity and liabilities 48,4 70,8 57,7 15,5 4,0 8,0

Cash flows

MSEK 2017 2016 2015 2014 2013 2012 Acummulated Operating activities

• 57,3

8,0

• 28,8
• 8,0
• 3,7

7,1

• 82,9

Investing activities

• 6,0
• 0,8
• 1,0
• 0,9
• 2,4
• 0,1
• 11,0

Financing activities 33,2

• 66,7

17,6

• 0,1

117,5 Cash flow

• 30,1

7,2 36,9 8,7

• 6,1

7,1 23,7

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Nice & Green convertible note financing of up to 144M SEK

Nice & Green is a private Swiss company, which specializes in financing solutions tailored to the requirements of listed growth companies within the biotech and cleantech industries Very flexible call option Saniona may draw SEK 6 million per month at its discretion Non utilized tranches rolls over and extends option period Reasonable costs No interest on convertibles N&G may convert at a discount of 8% to 5 days VWAP (volume weight average price) N&G receives a commitment fee in line with industry standard where as Saniona receives a percentage of N&G’s net capital gain. Estimated net transaction costs to Saniona of 3-4% No warrant coverage or other financial obligations to Saniona N&G to promote Saniona in N&G’s network

Arranges 4 major investor meetings in Switzerland, Germany and France totalling more than 100 investors

First meeting took place in April in Geneva Status of transaction is communicated at Saniona’s homepage and through press releases upon the issue of new shares

May cover planned activities until 2020 excluding lump sum payments from partners

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Potential inflection points within the next 12 months

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 activities within eating disorders for the US and EU markets (PWS, other) New activities within metabolic field (Phase 2b in obesity) NS2359: Interim data for NS2359 in cocaine addiction CAD-1883: Results and new initiatives by Cadent Therapeutics in relation to ataxia and Tremor SAN711: Completion of pre-clinical development and initiation of Phase 1 for chronic pain and itching Progress and potential milestones under existing research collaborations Potential new collaborations or spin-outs from our world class research team Not listed chronological

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Summaryary

Clinical stage Phase 3 company

1

• Tesofensine in Phase 3 for obesity – Medix partnership
• Tesomet in Phase 2a for PWS
• NS2359 in Phase 2a for cocaine addiction – sponsored by grants
• Preparation of Phase 2b for Tesomet in both metabolic diseases and eating disorders
• CAD-1883 in Phase 1 for ataxia and tremor – Cadent partnership

Upcoming milestones

3

• Results from Medix Phase 3 study
• Next steps in eating disorders e.g. Prader Willi studies
• Future studies in metabolic diseases
• Interim data for NS2359 in cocaine addiction
• Progress and potential milestones under existing collaborations
• Potential new collaborations or spin-outs from our world class research team

Additional value drivers: Partnerships with significant potential – Unique platform technology

2

• Several partnerships
• Three spin-outs

Go to market

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Saniona AB Baltorpvej 154 DK-2750 Ballerup Denmark Tel: +45 70705225 Web: saniona.com