Genfit Sa · EURONEXT:GNFT
Genfit Sa — Investor Presentation (June 2023)
28 slides from Genfit Sa's investor presentation, June 2023
Slide 1: Corporate Presentation: Positive Results from Phase III ELATIVE Trial
Corporate Presentation P o s i t i v e R e s u l t s f ro m P h a s e I I I E L AT I V E ® Tr i a l o f e l a f i b ra n o r i n P a t i e n t s w i t h Primary Biliary Cholangitis JUNE 2023
Slide 2: Disclaimer & Looking Forward Statement
Disclaimer & Looking Forward Statement IMPORTANT NOTICE – YOU MUST READ THE FOLLOWING BEFORE CONTINUING. THIS PRESENTATION HAS BEEN PREPARED BY GENFIT AND IS FOR INFORMATION PURPOSES ONLY. CERTAIN OF THE INFORMATION CONTAINED HEREIN CONCERNING ECONOMIC TRENDS AND PERFORMANCE IS BASED UPON OR DERIVED
Slide 3: About GENFIT
About GENFIT Mission & Expertise Financials GENFIT is a French late-stage biopharmaceutical company • Listed on the Nasdaq Global Select Market and on dedicated to improving the lives of patients with rare and/or severe compartment B of Euronext’s regulated market in liver diseases. Paris (Nasdaq an
Slide 4: Our Mission
Our Mission + + Our mission is to remain a pioneer in the field of liver diseases, i.e., identify high potential assets to bring them from discovery + or early stages up to late development stages, typically the end of Phase 3. We capitalize on our scientific, clinical and regulatory expertise in th
Slide 5: Our Purpose & Core Values
Our Purpose & Core Values OUR PURPOSE Our purpose supports our long-term commitment with regards to the We intend to create general public benefit by generating a positive role we want to play in society, not only as an economic player seeking to and significant social, societal and environmental im
Slide 6: We Focus our R&D Efforts & Expertise on Critical Liver Diseases
We Focus our R&D Efforts & Expertise on Critical Liver Diseases Rare diseases • Medical condition that affects a relatively small number of people in a population: US: <200,000 individuals1,2|EU: <1 in 2,000 people1,2 Severe diseases • 7 000 rare diseases | 400M patients worldwide • 95% do not have
Slide 7: 24 Years of Agile Corporate Strategy Evolution
24 Years of Agile Corporate Strategy Evolution Inception Clinical development Pipeline expansion & diversification & early years in Non-Alcoholic Steatohepatitis (NASH) in rare/severe liver diseases with high unmet needs 1999 2023 Development of Research Development of Development of a diversified p
Slide 8: 7 Therapeutic Programs from Early to Late Development Stage
7 Therapeutic Programs from Early to Late Development Stage A regular stream of clinical data expected in the coming years Late-stage therapeutics1 Preclinical Phase 1 Phase 2 Phase 3 Next steps2 ELAFIBRANOR3 in PBC Orphan Drug Designation by the FDA & EMA | Breakthrough Therapy Designation by the F
Slide 9: Focus on Primary Biliary Cholangitis (PBC)
THERAPEUTICS RARE DISEASES Focus on Primary Biliary Cholangitis (PBC) Disease State · Unmet Needs GENFIT Program · Elafibranor in PBC 30/06/2023
Slide 10: PBC | Inflammation and Destruction of Bile Ducts
PBC | Inflammation and Destruction of Bile Ducts ! PBC | DISEASE STATE Liver Bile ducts gradually destroyed PBC in brief Smaller bile ducts = Bile acid circulation Inflammation PBC = rare autoimmune disease and Toxicity of the liver Intrahepatic bile ducts Common bile duct • Causes the immune system
Slide 11: A Mechanism of Action Addressing Multiple Pathways
A Mechanism of Action Addressing Multiple Pathways ELAFIBRANOR | IN PBC • Elafibranor is a dual PPAR-α and PPAR-δ agonist • Strong mechanistic rationale for potential benefit in cholestatic liver disease PPARα/δ activation2 INCREASED DECREASED INCREASED DECREASED INHIBITION OF Bile acid Bile acid Bi
Slide 12: Compelling Results from the Phase 2b Study
Compelling Results from the Phase 2b Study ELAFIBRANOR | IN PBC Statistically significant treatment effects with both 80mg and 120mg Elafibranor is a competitive doses on the primary end-point* of serum alkaline phosphatase 2L candidate for PBC (ALP) change from baseline Change from baseline in ALP
Slide 13: Phase 3 ELATIVE | Clinical Trial Design
Phase 3 ELATIVE ® | Clinical Trial Design ELAFIBRANOR | IN PBC ELATIVE® – Pivotal Phase 3 Study in Patients with Primary Biliary Cholangitis 52 WEEKS RANDOMIZED 2:1 DOUBLE BLIND PLACEBO CONTROLLED GLOBAL STUDY (>100 CENTERS)1 Inclusion criteria Primary Endpoint 18-75 years old • N=100 | elafibranor
Slide 14: Phase 3 ELATIVE | Positive Top Line Data
Phase 3 ELATIVE ® | Positive Top Line Data ELAFIBRANOR | IN PBC 30/06/2023 14
Slide 15: A Strong Partnership to Optimize Potential Commercialization
A Strong Partnership to Optimize Potential Commercialization ELAFIBRANOR | IN PBC €120M Up to €360M in Tiered double- 8% shareholder Responsibility for all additional upfront payment milestone payments digit royalties of of GENFIT via clinical development, including up to 20% equity investment compl
Slide 16: Near Term Milestones and Commercial Opportunity
Near Term Milestones and Commercial Opportunity ELAFIBRANOR | IN PBC ® Phase 3 in brief 4Q21 Signing of a licensing agreement with Ipsen for the global rights to develop and commercialize elafibranor PBC market estimates Mid-22 Recruitment of the last patient Potential elafibranor peak sales $500+ m
Slide 17: Other development programs
THERAPEUTICS RARE & SEVERE DISEASES Other development programs Program description · Mechanism of action Current development phase · Available data 30/06/2023
Slide 18: GENFIT pipeline | MoAs & Supporting Evidence
GENFIT pipeline | MoAs & Supporting Evidence Expanded and diversified pipeline in rare and severe liver diseases with high unmet medical needs VS-01 NTZ SRT-015 GNS561 VS-01 VS-02 in ACLF in ACLF in ACLF in CCA UCD/OA in HE with complementary mechanisms of action ACLF franchise = 3 programs Potentia
Slide 19: Conclusion
Conclusion A world leadership position Positive Topline Data from in ACLF, with 3 clinical-stage Phase III ELATIVE® Trial of assets, based on elafibranor in Patients differentiated MoAs, potential with Primary Biliary for expedited regulatory Cholangitis pathways opportunity for near-term expected t
Slide 20: GENFIT – Market insights
GENFIT – Market insights IQVIA perspective on the commercial opportunity of GENFIT’s pipeline June 2023 © 2022. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Slide 21: Disclaimer
Disclaimer • IQVIA is not an “authorized person” for the purposes of the Financial Services and Markets Act 2000 (“FSMA”) and does not provide investment advice or carry on any other regulated activity under Part II of the FSMA 2000 (Regulated Activities) Order 2001. • Projections and related inform
Slide 22: GENFIT moving to a diversified portfolio of rare liver diseases
While keeping its footprint in hepatology, GENFIT is now moving to a diversified portfolio covering multiple rare liver related diseases with high unmet needs Urea Cycle Disorders (UCDs) Cholangiocarcinoma (CCA) UCDs are a set of rare inherited metabolic conditions in CCA are malignancies of the bil
Slide 23: The six pursued indications have low prevalence and could be eligible for orphan designation
The six pursued indications have low prevalence and could potentially be eligible for orphan designation Estimated current prevalence (1:100,000) 1,100.0 1,100 EU5 US 650.0 650 640 FDA ODD threshold (indicative) EMA ODD threshold 50 40.7 40.7 40.0 40 33.0 32.0 29.0 30 20 10 4.7 4.7 0.3 0.4 0.3 0.2 0
Slide 24: All 6 diseases have a high impact on patients’ lives and high unmet needs
All 6 diseases have a high impact on patients’ lives and high unmet needs Burden of disease Unmet needs & approved therapies ⚫ Potentially life-threatening condition ⚫ Current approved HE treatments are HE ⚫ Significant impairments in multiple health-related quality of life domains associated with s
Slide 25: GENFIT has a well-balanced portfolio across disease areas
GENFIT has a well-balanced portfolio across disease areas with limited treatment options and lower development costs(1) • Diversified portfolio with multiple assets and Portfolio modes of action across various indications Moving from one asset in NASH into pipeline • Six liver-related diseases most(
Slide 26: These 6 indications represent an overall ~12,5 bn USD market opportunity
These 6 indications represent an overall ~12,5 bn USD market opportunity Estimated overall market size (US+UE5) by 2030, bnUSD Assumptions(3) • Prevalence: 155K (EU5) / 80k (US) for grade 1 / 2 ACLF patients • Drug price could amount to $30-40k per patient in US in secondary prevention ACLF 2.2 1.6
Slide 27: Conclusion
Conclusion Novel Potential Sizable mechanisms expedited commercial of action approval opportunity pathways • Elafibranor: only asset targeting • Orphan drug designation granted for both PPARα/δ receptors for PBC elafibranor in PBC (FDA/EMA), VS-01 in ACLF • VS-01: First-in-class liposomal- (FDA) and
Slide 28: We thank you for your attention
We thank you for your attention JUNE 2023