Valbiotis Sa · EURONEXT:ALVAL
Valbiotis Sa — Investor Presentation (March 2021)
52 slides from Valbiotis Sa's investor presentation, Mar 8, 2021
Slide 1: Valbiotis Investors Presentation March 2021
1 VALBIOTIS INVESTORS PRESENTATION March 2021
Slide 2: Agenda
2 01. VALBIOTIS / Corporate 02. TOTUM-63, to reduce the risk of type 2 diabetes 03. TOTUM-070, to reduce hypercholesterolemia 04. TOTUM-854, to reduce blood pressure 05. TOTUM-448, to reduce non-alcoholic hepatic steatosis (NAFL) 06. FINANCIAL INFORMATION
Slide 3: An R&D company committed to scientific innovation against metabolic diseases
3 A R&D company, committed to scientific innovation, for preventing and combating metabolic diseases Active substances from plants and based on science, to address unmet medical needs • An innovative approach, enabled by a specific expertise of plants • A high level of evidence, with clinical studie
Slide 4: Nutrition Healthcare: a portfolio of active substances in clinical stages
4 Nutrition Healthcare: a portfolio of active substances, in clinical stages Phase II Phase II/III Study launch Results TOTUM-63 / Prediabetes Mid-2020 S1 2022 TOTUM-070 / Hypercholesterolemia Q4 2020 S1 2022 TOTUM-854 / Arterial hypertension S1 2021 2022 © NON CONFIDENTIAL TOTUM-448 / Fatty Liver S
Slide 5: The success of an innovative model proven effective in only 6 years
5 The success of an innovative model First strategic partnership with a global healthcare player • Up to 71 M CHF upfront and milestones payments in health industry, 2020 + Royalties on net sales + Supply revenue proven effective Development of other products of the pipeline in only 6 years followin
Slide 6: An expert management team for healthcare innovation
6 An expert management team for healthcare innovation Sébastien PELTIER Jocelyn PINEAU Pascal SIRVENT Murielle CAZAUBIEL Josep INFESTA CEO, PhD - HDR. MBA. PhD - HDR. M.Sc. MD, MBA Chairman of the Board of Directors CFO, Member of the board CSO, Member of the board CMO, Member of the board Head of G
Slide 7: Supervisory Board
7 An expert management team for healthcare innovation Supervisory Board Laurent LÉVY, PhD Agnès TIXIER Sébastien BESSY Dr Jean ZETLAOUI, MD, MBA Chairman of the Supervisory Board Audit Committee Remuneration Committee Audit Committee Remuneration Committee Executive Director, Vice President Global S
Slide 8: A unique partnership in the field of Nutrition Health
8 A unique partnership in the field of Nutrition Health A long-term strategic partnership for the development and worldwide commercialization of TOTUM-63 in prediabetes. A worldwide contract signed before pivotal phase A license and supply agreement Milestones payments: up to CHF 66 million, coverin
Slide 9: Strategic roadmap 2021-2022
9 Strategic roadmap 2021-2022 2022 2021 TOTUM-63 (prediabetes, T2D) Results of Phase II/III REVERSE-IT study (S1) Objectives Health claim file 1. Success of the Alliance Management TOTUM-63 (prediabetes, T2D) TOTUM-070 (LDL cholesterol) with Nestlé Health Science Scientific publications Results of P
Slide 10: High-value scientific & medical supervisory board
10 High-value scientific & medical supervisory Board 700 scientific publications: Diabetes Care, The Lancet, Nature Pr Samy HADJADJ Bruno GUIGAS Pr Jean-Marie BARD Nathalie BOISSEAU Thierry MAUGARD André MARETTE MD, PhD, PU-PH PhD PharmD, PhD, PU-PH PhD, PU PhD, PU PhD - Laval University Hospital Na
Slide 11: R&D centers dedicated to metabolic diseases
11 3 R&D centers dedicated to metabolic diseases Plant-based chemistry Design of active substances (compliant with pharmacopeia US / EU). Extraction processes, characterisation, purification, bioengineering, pharmaco-modulation. Discovery & Preclinical Research In vivo screening on relevant models o
Slide 12: Nutrition Healthcare: a high level of evidence for prevention
12 Nutrition Healthcare: a high level of evidence for prevention A R&D process following the outline of pharmaceutical development. A short development cycle: 6-7 years Research Preclinical studies Clinical studies Regulatory approval FDA, EFSA Health Canada, other regulatory authorities by country
Slide 13: Health claims: well established regulatory processes
13 Health claims: well established regulatory processes Different frames among countries. Food supplement status Food supplement status Natural health product Set product specifications Composition, quality Composition, quality Quality + evidence regarding and quality management. & safety ± safety s
Slide 14: The business model: strategic agreements with global health players
14 The business model: strategic agreements with global health players Long term strategic Commercialization model partnerships Target population Global agreements along the products life cycle: Subjects at risk - Last stages of clinical development of developing - Galenic development and supply met
Slide 15: Nutrition Health products in clinical development stages
15 Nutrition Healthcare 4 Nutrition Health products in clinical development stages, to reduce the risk of developing metabolic diseases © NON CONFIDENTIAL
Slide 16: A global IP strategy across the portfolio
16 A global IP strategy across the portfolio 4 patent families applications worldwide Demonstrates that innovative combinations of plant extracts are patentable for a healthcare purpose in food, supplements or pharmaceuticals products > “ Plant extracts / molecules ”. All patents registered internat
Slide 17: Solid scientific results selected by major international scientific societies
17 17 Solid scientific results selected by major international scientific societies 17 Communications during scientific congresses since 2016 Including 11 accepted communications in the 3 major diabetes congresses worldwide: - American Diabetes Association (ADA) - European Association for the Study
Slide 18: TOTUM-63, to reduce the risk of type 2 diabetes
18 TOTUM-63, to reduce the risk of type 2 diabetes © NON CONFIDENTIAL
Slide 19: Prediabetes: an opportunity for diabetes prevention
19 Prediabetes: an opportunity for diabetes prevention “Prediabetes should not be considered as a disease but as a high-risk stage of developing T2 diabetes”1 TYPE 2 DIABETES IRREVERSIBLE AT-RISK STAGE metabolic impairments (in most cases) Lifelong treatments, PREDIABETES Risk of progression to type
Slide 20: Prediabetes: a favourable medical environment for new products
20 Prediabetes: a favourable medical environment for new products An easy diagnosis in primary care, based on simple blood tests. MODERATE FASTING HYPERGLYCEMIA MODERATE FASTING HYPERGLYCEMIA Fasting glycemia from: HbA1c: Fasting glycemia from: 1,00 to 1,25 g/L I ≥ 5,7% and < 6,5% 1,10 and 1,25 g/L
Slide 21: TOTUM-63: a combination of plant extracts for people with prediabetes
21 TOTUM-63: A combination of a worldwide innovation plant extracts designed for people with prediabetes Complete characterisation First clinically proven and natural of the biomolecules solution created to reduce the risk (HPLC-UV/MS) of developing type 2 diabetes. • Clinical evidence of efficacy a
Slide 22: TOTUM-63: multitarget action on several tissues
22 TOTUM-63: an active substance for a multitarget action on several tissues WHITE ADIPOSE TISSUE involved in metabolic regulation Insulin I IR IRS1 LIVER ↓ Inflammation PI3K ↓ Expression lipid storage genes G ↓ Pro-inflammatory ↑P ↓Fsp27 GLU Akt Glucose L macrophages G T4 AT ↓PL Intestinal microbio
Slide 23: TOTUM-63: preclinical data on type 2 diabetes prevention
23 TOTUM-63: preclinical data Diabetic mice model: db/db High Fat Diet mice on type 2 diabetes (HFD) prevention Prevention protocols Positive and significant results on: • Fasting glycemia • Insulin-resistance • Body weight • Fat mass © NON CONFIDENTIAL Low fat diet, LFD (n= 10) Control (n=10) High
Slide 24: TOTUM-63: preclinical data on type 2 diabetes reversion
24 TOTUM-63: preclinical data on type 2 diabetes reversion Reversion protocols High Fat Diet mice Positive and significant results on: • Post-prandial glycemia • Insulin-resistance • Body weight • Fat mass Low fat diet, LFD (n= 10) High fat diet, HFD (n= 12) HFD + TOTUM-63 (n= 12) © NON CONFIDENTIAL
Slide 25: TOTUM-63: Phase II clinical results
25 TOTUM-63: Phase II clinical results Study design Study population • Multicenter, randomised, unbalanced 51 prediabetics with abdominal obesity associated (3:1, TOTUM-63:Placebo) and double-blind with moderate hyperglycemia, hyperglycemia placebo-controlled study, 2 parallel-groups at 2 hours (OGT
Slide 26: Primary endpoint met: reduction in fasting glycemia
26 TOTUM-63: Phase II clinical results Primary endpoint met: reduction in fasting glycemia vs. placebo TOTUM-63 – 9.3%a © NON CONFIDENTIAL aDifference of the means of individual variations expressed in %
Slide 27: Secondary endpoint: reduction in 2h-glycemia
27 TOTUM-63: Phase II clinical results Secondary endpoint met: reduction in 2h-glycemia (OGTT) vs. placebo TOTUM-63 – 22.5%a © NON CONFIDENTIAL aDifference of the means of individual variations expressed in %
Slide 28: Secondary endpoints: anthropometric parameters
28 TOTUM-63: Phase II clinical results Secondary endpoints met: reduction in anthropometric parameters vs. placebo TOTUM-63 – 4.48 cma – 1.9 kga © NON CONFIDENTIAL Values are expressed as mean ± SEM. ** p<0.05 aDifference of the means of individual variations
Slide 29: Secondary endpoints: triglyceridemia and Fatty Liver Index
29 TOTUM-63: Phase II clinical results Secondary endpoints met: reduction in triglyceridemia and Fatty Liver Index vs. placebo TOTUM-63 – 32.2%a – 18.7%a © NON CONFIDENTIAL Values are expressed as mean ± SEM. ** p<0.01 FLI ≥ 60: High probability of steatosis aDifference of the means of individual va
Slide 30: Secondary endpoints: systolic blood pressure
30 TOTUM-63: Phase II clinical results Secondary endpoints met: reduction in systolic blood pressure vs. placebo Sub-population: subjects with high Overall population blood pressure Systolic blood pressure evolution Systolic blood pressure evolution (from baseline to 6 months), overall population (f
Slide 31: REVERSE-IT: international Phase II/III pivotal study
31 REVERSE-IT: the international Phase II/III 600 subjects pivotal study in prediabetics and untreated Type 2 diabetics Randomization Study design An international multicentric, randomized, TOTUM-63 Placebo TOTUM-63 placebo-controlled, double blind study. 5.0 g 3 intakes 5.0 g Dose: 5 g/day (3 intak
Slide 32: Prediabetes market data
32 Prediabetes 86 market data (33.9%) Prediabetic adult population per country Million adults (% of overall adult population) 14 (20.2%) 12 (24.2%) 900 million prediabetics in the world 134 million adults with prediabetes 6 (22.1%) 6 (total USA, Canada, Top 5 Europe) (15.8%) 5 (10.1%) 13.4 million 4
Slide 33: TOTUM-070, to reduce hypercholesterolemia
33 TOTUM-070, to reduce hypercholesterolemia © NON CONFIDENTIAL
Slide 34: LDL hypercholesterolemia: a risk factor for cardiovascular diseases
34 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 cholesterolemia Atherosclerosis Myocardial infarction LDL Alone or associated Risk ++ of cardiovascular morta
Slide 35: TOTUM-070: a combination of plant extracts for LDL hypercholesterolemia
35 TOTUM-070: A combination of developed for people with plant extracts mild to moderate LDL hypercholesterolemia, a risk factor for cardiovascular Complete characterisation of the biomolecules diseases (HPLC-UV/MS) • An innovating composition, 100% natural, patented, without phytosterol nor red ric
Slide 36: TOTUM-070: main hypothesis for multitarget mode of action
36 TOTUM-070: the main hypothesis currently studied, for a multitarget mode of action CYP7A1 on lipid metabolism Bile acids Ongoing G8 5/ CG Fatty acids Bile AB Bile acids l Ongoing ro Cholesterol duct te es GUT ol e en Ch Cholesterol HM l ua GC e Sq at R L1 ApoB100 on LIVER C1 al Ongoing NP ev Ongo
Slide 37: The HEART clinical study, a Phase II to reduce LDL cholesterol
37 The HEART clinical study, a Phase II to reduce LDL blood cholesterol 120 subjects Randomization Study design A randomized, placebo-controlled, double blind study Population: 120 subjects Dose: 5 g/day TOTUM-070 Launched Placebo 5 g /day Q4 2020 5 g /day N=60 Duration: N=60 Study population 6 mont
Slide 38: Mild to moderate LDL hypercholesterolemia: the market data
38 Mild to moderate LDL hypercholesterolemia: 1.2 the market data billion euros A large and well established 39% market in USA & Europe Top 5 of adults worldwide with high cholesterol * Adults with moderately elevated LDL cholesterol (total USA & Top 5 Europe) 174 million 64.1 M 23.1 M 30.5 M 19.5 M
Slide 39: TOTUM-854, to reduce blood pressure
39 TOTUM-854, to reduce blood pressure © NON CONFIDENTIAL
Slide 40: Arterial hypertension: the leading cardiovascular risk factor
40 Arterial hypertension (AHT): the leading cardiovascular risk factor in the world - Hemorrhagic Stroke - Ischemic “The continuous relationship between blood pressure and risk of cardiovascular events has been shown at all ages and in all ethnic groups, and extends from high blood pressure levels t
Slide 41: Arterial hypertension: the leading cardiovascular risk factor in the world
41 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 is established at 120 mmHg * when the heart contracts (systolic pressure) and at 80 mmHg when
Slide 42: TOTUM-854: a combination of plant extracts for elevated blood pressure
42 TOTUM-854: developed for people A combination of plant extracts with mild to moderate elevation of blood pressure, a risk factor for Complete characterisation of the biomolecules cardiovascular diseases (HPLC-UV/MS) • An innovating composition, 100% natural, patented. • An ongoing partnership wit
Slide 43: A Phase II clinical study for the reduction of blood pressure
43 A Phase II clinical study for the reduction of blood 100 subjects pressure Randomization Design study A randomized, placebo-controlled, double blind study TOTUM-854 Launch: Placebo Population: 100 subjects 2.5 g S1 2021 2.5 g / day / day Dose: 2.5 g/day Duration: N=50 6 months N=50 Population stu
Slide 44: Mild to moderate elevation of blood pressure: the market data
44 Mild to moderate elevation of blood pressure: the market data 1.15 billion euros The mild to moderate raise of blood pressure market in USA + Europe Top 5 Adults with moderate elevation of blood 124 million pressure (total USA & Top 5 Europe) 77 million Adults diagnosed (total USA & Top 5 Europe)
Slide 45: TOTUM-448, to reduce non-alcoholic hepatic steatosis
45 TOTUM-448, to reduce non-alcoholic hepatic steatosis © NON CONFIDENTIAL
Slide 46: Hepatic steatosis: an opportunity to prevent NASH
46 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 hepatocytes 1 HEPATIC Fibrosis, HEALTHY STEATOSI
Slide 47: Non alcoholic hepatic steatosis, established specific medical practices
47 Non alcoholic hepatic steatosis, established specific medical practices Recommendations for systematic screening in at-risk populations2: - Patients with obesity, insulin-resistance, metabolic syndrome, type 2 diabetes. Liver ultrasonography: the recommended non invasive first line exam for diagn
Slide 48: TOTUM-448: for people with non-alcoholic fatty liver disease
48 TOTUM-448: developed for people with non-alcoholic fatty liver disease, A combination of plant extracts at risk of NASH Complete characterisation of the biomolecules (HPLC-UV/MS) Initiation of the Phase II clinical study planned for S2 2021 © NON CONFIDENTIAL
Slide 49: Financial information
49 Financial information © NON CONFIDENTIAL
Slide 50: Analysts coverage and shareholders breakdown
50 Analysts coverage Shareholders breakdown 14.70 EUR Target price (data September 2020) 13 % Portzamparc + 96% * Management Christophe DOMBU / Mohamed KAABOUNI 13.70 EUR Target price (data February 2021) + 83% * Invest Securities Thibaut VOGLIMACCI-STEPHANOPOLI 27.1% 13.50 EUR Retail shareholders T
Slide 51: Cash and R&D expenses
51 Cash and R&D expenses IFRS in K€, at June 30 2020 2019 Cash Position: € 10.9 million Operating income, including 714 1,023 (at 30/06/2020) Turn over 121 46 Grants 156 372 Not included: first milestone payment from Nestlé Research Tax Credit 437 605 Health Science (CHF 3 M), fundraise from Amiral
Slide 52: Valbiotis Investors Presentation March 2021
52 VALBIOTIS INVESTORS PRESENTATION March 2021