Valbiotis Sa · EURONEXT:ALVAL
Valbiotis Sa — Investor Presentation (April 2021)
60 slides from Valbiotis Sa's investor presentation, April 2021
Slide 1: Investors Presentation
April 2021 Investors Presentation
Slide 2: Disclaimer
Disclaimer IMPORTANT: You must read the following before continuing. In accessing this document, you agree to be bound by the following terms and conditions. This document has been prepared by VALBIOTIS SA (the « Company ») and is for information purposes only. The content of this document is provis
Slide 3: Summary
Summary Introduction – Our mission Valbiotis • Preventing metabolic disease: our job • An expert management • An efficient business model with an ambitious roadmap • R&D and manufacturing, the core of our development TOTUM • TOTUM•63: to reduce the risk of type 2 diabetes • TOTUM•070: to reduce hype
Slide 4: Our mission
Our mission New cases of metabolic and cardiovascular disease are on the rise in France and worldwide. At Valbiotis, with our research and development teams, we develop nutrition healthcare products, based on a multitarget approach enabled by the use of plants and benefitting from a high level of ev
Slide 5: Preventing metabolic disease: our job
Preventing metabolic disease: our job An expert management An efficient business model with an ambitious roadmap R&D and manufacturing, the core of our development Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 5
Slide 6: Nutrition healthcare
Nutrition healthcare 4 products in clinical development stages, to reduce the risk of developing metabolic diseases Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 6
Slide 7: Preventing and combating metabolic diseases: commitment to scientific innovation
7 Preventing and combating metabolic diseases: the commitment of Valbiotis to scientific innovation Development of active substances derived from plants and based on science, to address unmet medical needs An innovative A high level A pipeline 4 patent families and multitarget of evidence, of innova
Slide 8: Nutrition healthcare: a portfolio of active substances, in clinical stages
8 Nutrition healthcare: a portfolio of active substances, in clinical stages Development stage Status Results Prediabetes Phase II/III Recruitment ongoing Mid-2022 Phase II Recruitment ongoing S1 2022 Hypercholesterolemia Phase II Launch upcoming S1 2021 Arterial hypertension Hepatic steatosis Phase
Slide 9: An innovative model in health industry, proven effective in only 6 years
An innovative model in health industry, proven effective in only 6 years 2014 – 2016 2017 - 2019 2020 Foundation of VALBIOTIS Initial Public Offering First strategic partnership • Internalization of the R&D with a global healthcare • First fundraising platform player • Discovery of TOTUM•63: • Up to
Slide 10: An expert management
Preventing metabolic disease: our job An expert management An efficient business model with an ambitious roadmap R&D and manufacturing, the core of our development Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 10
Slide 11: An expert management team for healthcare innovation
An expert management team for healthcare innovation Sébastien Jocelyn Pascal Murielle Josep PELTIER PINEAU SIRVENT CAZAUBIEL INFESTA CEO, PhD – HDR, MBA. CFO, PhD - HDR. CSO, M.Sc. CMO, MD, MBA Head of Global Co-founder, Chairman Co-founder, Member of the board Member of the board Business Developme
Slide 12: Supervisory board
An expert management team for healthcare innovation Supervisory board Laurent Agnès Sébastien Dr Jean LÉVY TIXIER BESSY ZETLAOUI PhD – Chairman Audit Committee Remuneration Committee MD – MBA of the Supervisory Board Executive Director, Vice President Global Audit Committee Remuneration Committee Cr
Slide 13: An efficient business model with an ambitious roadmap
Preventing metabolic disease: our job An expert management An efficient business model with an ambitious roadmap R&D and manufacturing, the core of our development Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 13
Slide 14: An efficient business model based on strategic agreements
14 An efficient business model based on strategic agreements with major healthcare players Long term Commercialization strategic partnerships model A double model, to generate growth: Target population 1. License agreements: Subjects at risk of developing Lump sum payments: upfront, milestones metab
Slide 15: The power of a unique partnership in nutrition healthcare
The power of a unique partnership in the field of nutrition healthcare A long-term strategic partnership for the development and worldwide commercialization of TOTUM•63. A worldwide contract signed before pivotal phase: • Milestones payments up to CHF 66 millions, including the funding of TOTUM•63 d
Slide 16: 2021-2022: an ambitious strategic roadmap
2021-2022: an ambitious strategic roadmap 2022 TOTUM•63 (prediabetes, T2D) 2021 Results of Phase II/III REVERSE-IT study (S1) Objectives Health claim file TOTUM•63 (prediabetes, T2D) 1. Success of the Alliance Management Scientific publications with Nestlé Health Science End of recruitment for Phase
Slide 17: R&D and manufacturing, the core of our development
Preventing metabolic disease: our job An expert management An efficient business model with an ambitious roadmap R&D and manufacturing, the core of our development Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 17
Slide 18: The expertise of a renowned scientific and medical board
The expertise of a renowned scientific and medical board Over 700 scientific publications, incl. prestigious journals: Diabetes Care, The Lancet, Nature Pr Samy Pr Jean-Marie Bruno Nathalie Thierry André HADJADJ BARD GUIGAS BOISSEAU MAUGARD MARETTE MD, PhD, PU-PH PharmD, PhD, PhD PhD, PU PhD, PU PhD
Slide 19: The strength of an internal R&D
The strength of an internal R&D La Rochelle center Plant chemistry Design of active substances (compliant with pharmacopeia US / EU). Extraction processes, characterisation, purification, bioengineering, pharmaco-modulation. La Rochelle center Plant chemistry Périgny center Riom center Clinical deve
Slide 20: The ambition to achieve a high level of evidence in Nutrition Healthcare
The ambition to achieve a high level of evidence in the field of Nutrition Healthcare A R&D process, for prevention, following the outline of pharmaceutical development A short development cycle: 6-7 years* Research Preclinical studies Clinical studies Industrial development Regulatory approval manu
Slide 21: A global intellectual property strategy across the portfolio
A global intellectual property strategy accross the portfolio Patents applied for in more than 60 countries Demonstrates that innovative combinations of plant extracts are patentable for a healthcare purpose in food, supplements or pharmaceuticals products > “ Plant extracts / molecules ”. All paten
Slide 22: Solid scientific results selected by major international scientific societies
Solid scientific results selected by major international scientific societies In 2020 Positive Phase II clinical results on TOTUM•63 selected by both ADA and EASD congresses. 17 communications during scientific congresses since 2016 Including 11 accepted communications in the 3 major diabetes congre
Slide 23: Health claims as a guarantee: well-established regulatory pathways
Health claims as a guarantee: well-established regulatory pathways A regulatory frame in each of the targeted countries. Food supplement status Food supplement status Food supplement status Set product specifications Quality + evidence regarding safety Composition, quality & safety Composition, qual
Slide 24: Expertise in industrial development and production of our active substances
24 Expertise in industrial development and production of our active substances Activities Quality commitment Plant-extracts sourcing, compliant to regulatory, quality The quality and safety of our products are ensured by the and traceability requirements. attention we pay to the selection of the com
Slide 25: TOTUM
TOTUM TOTUM•63: to reduce the risk of type 2 diabetes TOTUM•070: to reduce hypercholesterolemia TOTUM•854: to reduce aterial hypertension TOTUM•448: to non-alcoholic hepatic steatosis (NASH) Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 25
Slide 26: Prediabetes: an opportunity for type 2 diabetes prevention
, prediabetes: an opportunity for type 2 diabetes prevention “Prediabetes should not be considered as a disease but as a high-risk stage of developing T2 diabetes”1 Type 2 Diabetes At-risk stage Irreversible metabolic impairments (in most cases) Prediabetes Lifelong treatments, costful and stressful
Slide 27: Prediabetes: a favourable medical environment for new products
, prediabetes: a favourable medical environment for new products A diagnosis in primary care, based on simple blood criteria. Moderate fasting hyperglycemia Moderate fasting hyperglycemia A recognition by international scientific societies and health Fasting glycemia from: HbA1c: Fasting glycemia fr
Slide 28: TOTUM-63: a worldwide innovation designed for people with prediabetes
: a worldwide innovation designed for people with prediabetes First clinically proven and natural solution created to reduce the risk of developing type 2 diabetes. A combination • Clinical evidence of efficacy already obtained in prediabetics, of plant extracts for the reduction of fasting glycemia
Slide 29: TOTUM-63: multitarget action on tissues involved in metabolic regulation
: an active substance for a multitarget action on several tissues involved in metabolic regulation Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 29
Slide 30: TOTUM-63: preclinical data on type 2 diabetes prevention
: preclinical data on Type 2 Diabetes prevention Diabetic mice model: db/db High Fat Diet-fed mice (HFD) Prevention protocols Control Control: Low Fat Diet Positive and significant results on: TOTUM•63 HFD **** p < 0.0001 • Fasting glycemia HFD + TOTUM•63 • Insulin-resistance **** p < 0.0001 • Body
Slide 31: TOTUM-63: preclinical data on type 2 diabetes reversion
: preclinical data on Type 2 Diabetes reversion Reversion protocols Souris High Fat Diet Control: Low Fat Diet HFD Positive and significant results on: Control: Low Fat Diet HFD + TOTUM•63 HFD • Post-prandial glycemia *p<0.05 *** p<0.001 HFD + TOTUM•63 • Insulin-resistance HFD Vs. HFD-T63: # p<0.05
Slide 32: TOTUM-63: Phase II clinical results (1/6)
: Phase II clinical results (1/6) Study design Study population Coordinating investigator • Multicenter, randomised, unbalanced 51 prediabetics with abdominal obesity (3:1, TOTUM•63:Placebo) and double-blind associated with moderate hyperglycemia, Dr. David Gendre (MD Biofortis) placebo-controlled s
Slide 33: TOTUM-63: Phase II clinical results (2/6)
: Phase II clinical results (2/6) Primary endpoint met: reduction in fasting glycemia versus placebo. Placebo a. Difference of the means of individual variations expressed in % TOTUM•63 Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 33
Slide 34: TOTUM-63: Phase II clinical results (3/6)
: Phase II clinical results (3/6) Secondary endpoint met: reduction in 2h-glycemia (OGTT) versus placebo. Placebo a. Difference of the means of individual variations expressed in % TOTUM•63 Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 34
Slide 35: TOTUM-63: Phase II clinical results (4/6)
: Phase II clinical results (4/6) Secondary endpoints met: reduction in weight and waist circumference versus placebo. Placebo a. Difference of the means of individual variations TOTUM•63 Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 35
Slide 36: TOTUM-63: Phase II clinical results (5/6)
: Phase II clinical results (5/6) Secondary endpoints met: reduction in blood triglycerides and fatty liver index (FLI) versus placebo. Placebo a. Difference of the means of individual variations expressed in % TOTUM•63 Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 36
Slide 37: TOTUM-63: Phase II clinical results (6/6)
: Phase II clinical results (6/6) Secondary endpoints met: reduction in blood pressure versus placebo. a. Difference of the means of individual variations expressed Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 37
Slide 38: REVERSE-IT, the international Phase II/III pivotal study
: REVERSE-IT, the international Phase II/III pivotal study in prediabetics and untreated Type 2 diabetics Study design 600 subjects An international multicentric, randomized, placebo-controlled, double blind study. Dose: 5 g/day 2 regimens: 2 and 3 intakes/day A 3-month follow-up period, post-supple
Slide 39: TOTUM-63: prediabetes market data
: prediabetes market data 86 (33.9%) Prediabetic adult 900 million population prediabetics in the world per country Million adults (% of overall adult population) 134 million adults with prediabetes in USA, Canada, Top 5 Europe 13,4 million adults diagnosed with prediabetes, waiting for a solution (
Slide 40: TOTUM
TOTUM TOTUM•63: to reduce the risk of type 2 diabetes TOTUM•070: to reduce hypercholesterolemia TOTUM•854: to reduce aterial hypertension TOTUM•448: to non-alcoholic hepatic steatosis (NASH) Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 40
Slide 41: LDL hypercholesterolemia: a risk factor for cardiovascular diseases
, LDL hypercholesterolemia: a risk factor for cardiovascular diseases “LDL-cholesterol is the primary cause of atheroscerosis.”1 Stroke Atheroma plates weakening and clogging arteries Hyper Myocardial cholesterolemia Atherosclerosis infarction LDL Alone or associated Risk ++ of with other cardiovasc
Slide 42: TOTUM-070: to reduce hypercholesterolemia
: to reduce hypercholesterolemia Developed for people with mild to moderate LDL hypercholesterolemia, a risk factor for cardiovascular diseases A combination of • An innovating composition, 100% natural, patented, plant extracts without phytosterol nor red rice yeast. • The HEART clinical study laun
Slide 43: TOTUM-070: multitarget mode of action on lipid metabolism
TOTUM•63 : hypothesis currently studied, for a multitarget mode of action on lipid metabolism Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 43
Slide 44: The HEART clinical study, a Phase II to reduce LDL cholesterol
: the HEART clinical study, a Phase II to reduce LDL blood cholesterol 120 subjects Study design A randomized, placebo-controlled, double blind study Population: 120 subjects Dose: 5 g/day TOTUM•070 Duration: Placebo Target population 5 g/day 6 months 5 g/day N=60 N=60 People with untreated mild to
Slide 45: Mild to moderate LDL hypercholesterolemia, the market data
: mild to moderate LDL hypercholesterolemia, the market data 39% of adults worldwide with high cholesterol* Adults with moderately elevated LDL cholesterol 174 million (total USA & Top 5 Europe) 64.1 M 19.5 M 23.1 M 14.7 M Adults diagnosed (total USA & Top 5 Europe) 83 million 30.5 M 22.2 M Patients
Slide 46: TOTUM
TOTUM TOTUM•63: to reduce the risk of type 2 diabetes TOTUM•070: to reduce hypercholesterolemia TOTUM•854: to reduce aterial hypertension TOTUM•448: to non-alcoholic hepatic steatosis (NASH) Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 46
Slide 47: Arterial hypertension, the leading cardiovascular risk factor in the world
: arterial hypertension (AHT), the leading cardiovascular risk factor in the world “ The continuous relationship between blood pressure and risk Stroke Hemorrhagic Ischemic of cardiovascular events has been shown at all ages and in all ethnic groups, and extends from high blood pressure levels to re
Slide 48: Arterial hypertension, the leading cardiovascular risk factor in the world
: arterial hypertension (AHT), the leading cardiovascular risk factor in the world 1.1 billion people with AHT in the world (2015).1 The world's first chronic disease. The normal blood pressure of an adult In Europe, AHT defined as arterial blood is established at 120 mmHg * when pressure ≥ 140/90 m
Slide 49: TOTUM-854: to reduce arterial hypertension
:: to reduce arterial hypertension Developed for people with mild to moderate elevation of blood pressure, a risk factor for cardiovascular diseases A combination of plant extracts • An innovating composition, 100% natural, patented. • An ongoing partnership with the University of Avignon Pharm- Eco
Slide 50: Mild to moderate elevation of blood pressure, the market data
: mild to moderate elevation of blood pressure, the market data Adults with moderate elevation of blood pressure (total USA & Top 5 Europe) 124 million 77 million Adults diagnosed (total USA & Top 5 Europe) Current average diagnosis rate (USA/UE) = 61% Adults diagnosed and who use food 32 million su
Slide 51: TOTUM
TOTUM TOTUM•63: to reduce the risk of type 2 diabetes TOTUM•070: to reduce hypercholesterolemia TOTUM•854: to reduce aterial hypertension TOTUM•448: to non-alcoholic hepatic steatosis (NASH) Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 51
Slide 52: Hepatic steatosis, an opportunity to prevent NASH and its complications
: hepatic steatosis, an opportunity to prevent NASH and its complications ”The progression from NAFL to NASH dramatically increases the risks of cirrhosis, liver failure, and hepatocellular carcinoma.”1 Reversible triglycerides accumulation in > 5% of hepatocytes1 Fibrosis, Hepatic Cirrhosis, Health
Slide 53: Non alcoholic hepatic steatosis, established specific medical practices
: non alcoholic hepatic steatosis, established specific medical practices Recommendations for systematic screening in at-risk populations2: Fatty Liver Index (FLI): a predictive score for screening in primary care1 • Patients with obesity, insulin-resistance, metabolic syndrome, type 2 diabetes. Bas
Slide 54: TOTUM-448: to reduce non-alcoholic hepatic steatosis
: to reduce non-alcoholic hepatic steatosis Developed for people with non-alcoholic fatty liver disease, at risk of NASH A combination of plant extracts Initiation of the Phase II clinical study planned for S2 2021 Combination of active biomolecules characterized by HPLC-UV/MS Investors Presentation
Slide 55: Financial information
Financial information Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 55
Slide 56: Analysts coverage and shareholders breakdown
Analysts coverage and shareholders breakdown 14.70 € Target price (data September 2020) Portzamparc + 88%* 13% Christophe DOMBU / Mohamed KAABOUNI Management 14.90 € Target price (data March 2021) Invest Securities + 86%* Thibaut VOGLIMACCI-STEPHANOPOLI 27.1% 13.50 € Retail Target price (data Januar
Slide 57: Cash and R&D expenses
Cash and R&D expenses IFRS in K€, at December 31, 2020 2020 2019 Cash position: € 14.6M Operating income, including 5,099 1,913 (at Dec. 31, 2020) • Turn over 3,092 91 • Grants 750 602 • Research Tax Credit 1,257 1,219 R&D expenses (5,411) (3,974) Sales and marketing expenses (1,031) (1,473) Overhea
Slide 58: Conclusion - Valbiotis overview
overview Investors Presentation - © NON CONFIDENTIAL April 2021 - 60 58
Slide 59: Valbiotis overview
Valbiotis overview 3 17 4 1 R&D centers Communications in Nutrition Healthcare Unique partnership scientific congresses products in the field of • Plant chemistry since 2016 nutrition healthcare • Discovery and preclinical Based on a multitarget approach research enabled by the use of plants, in cli
Slide 60: VAIDIOTIS: Peersstosetssi< cisco
e e VAIDIOTIS: Peersstosetssi< cisco