Inventiva SA · EURONEXT:IVA
Inventiva SA — H1 2022 Earnings Presentation
39 slides from Inventiva SA's earnings presentation, Sep 22, 2022
Slide 1: First-Half 2022 Financial Results
First-Half 2022 Financial Results September 22, 2022
Slide 2: Disclaimer
DISCLAIMER This presentation contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this presentation are forward-looking statements. These
Slide 3: Today's speakers
Today’s speakers Frédéric Cren, MA/MBA, Chairman, CEO and Co-Founder Pierre Broqua, Ph.D., CSO and Co-Founder Michael Cooreman, MD, CMO Jean Volatier, MA, CFO Philip Duong, Head of Investments at Sino Biopharm H1 2022 Presentation Non-confidential – Property of Inventiva │ 3
Slide 4: Summary
Summary Highlights Pipeline update Financials Near-term catalysts H1 2022 Presentation Non-confidential – Property of Inventiva │ 4
Slide 5: Highlights
Highlights
Slide 6: First-Half 2022 and recent highlights
First-Half 2022 and recent highlights Lanifibranor in non-alcoholic steatohepatitis (NASH) NATiV3 – Expansion in 24 countries and activation of close to 300 clinical sites for the NATiV3 Phase III clinical trial evaluating lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of l
Slide 7: First-Half 2022 Highlights
First-Half 2022 Highlights Cedirogant / ABBV-157 Ongoing Phase IIb clinical trial evaluating cedirogrant in approx. 200 adult patients with moderate to severe psoriasis with trial expected to end in H1 2023 Odiparcil In a meeting held during the summer the FDA provided feedback that – odiparcil
Slide 8: Pipeline update
Pipeline update
Slide 9: Lanifibranor in Nonalcoholic Steatohepatitis (NASH)
Lanifibranor in Nonalcoholic Steatohepatitis (NASH) A new generation pan-PPAR agonist for a safe and efficacious treatment of fibrotic conditions
Slide 10: NASH Competitive landscape
NASH Competitive landscape 2022 2023 2024 2025 2026 2027 2028 Part 1 results Q4 2022 Resmetirom, THR-β agonist Expected to refile Q3 / Q4 2022 Obeticholic acid, FXR agonist Part 1 results not communicated Semaglutide, GLP-1RA Part 1 results H2 2025 Lanifibranor, pan-PPAR agonist Part 1 results not c
Slide 11: NASH Competitive landscape: Fibrosis improvement
NASH Competitive landscape Lanifibranor, only oral drug achieving statistical significance on both endpoints EFFICACY Active Placebo xx Statistically significant xx Non-statistically significant Only oral drug achieving statistical significance on both endpoints Oral Injectables Lanifibranor Ocaliva
Slide 12: Development plan builds on NATIVE Phase IIb outcomes
The overall development plan builds on the successful outcomes of the NATIVE Phase IIb trial CLINICAL CLINICALDEVELOPMENT DEVELOPMENT Phase III in patients with NASH Registration and F2-F3 fibrosis Phase I Phase IIa Phase IIb (NATIVE) III OVERVIEW IIb DESIGN • 72 week Part 1 + Part 2 extension perio
Slide 13: Licensing and commercialization agreement
Licensing and commercialization agreement Inventiva expected to receive a $12 million upfront payment following the recent signature Additional $5 million expected in the short-term if certain clinical milestones are met Potential to receive a total of $290 million of clinical, regulatory and
Slide 14: Licensing and collaboration agreement with Sino Biopharm
Inventiva signed a licensing and collaboration agreement with Sino Biopharm1 to develop and commercialize lanifibranor in Greater China Sino Biopharm in brief: - One of the largest Chinese pharmaceutical groups listed in Hong Kong Exchange (HSI composite) with a market cap of c.US$10bn1 and c.US$4
Slide 15: Sino Biopharm is a leading Pharmaceutical Company in China
Sino Biopharm is a leading Pharmaceutical Company in China with a Global Reach Pharmaceutical (China)1 Chia Tai Tianqing Pharmaceutical Group (CTTQ) Tide Pharmaceutical A fully-integrated pharmaceutical; R&D and commercialization organisation market leader in oncology and liver for targeted drugs an
Slide 16: Sino Biopharm's pharma platform in China
Sino Biopharm’s extensive and comprehensive pharma platform in China Selected Manufacturing Sites Strong R&D and Clinical 11 R&D and manufacturing centers 68 innovative drug Beijing Pharmaceutical candidates under base clinical development Tide Pharm has China ~500 clinical operation GMP Cer
Slide 17: Sino Biopharm's Hepatology Franchise
Sino Biopharm’s Hepatology Franchise The largest market share in China Sino Biopharm’s Blockbusters Hepatology therapy market share of China in 2021 (1) 17% 2nd 8% 3rd 7% 4th 5% Tianqingganmei® Runzhong® 5th 4% Magnesium Isoglycyrrhizinate Entecavir Dispersible Tablets 6th 4% Injection 7th 4% 8th 4%
Slide 18: Status update of the NATiV3 Phase III trial
Status update of the NATiV3, Phase III clinical trial evaluating lanifibranor in patients with NASH PHASE III DESIGN SITE SELECTION 24 countries included of which 23 countries with full regulatory approval Activities paused in Ukraine where 10 sites were qualified including 3 sites already scree
Slide 19: Development plan builds on NATIVE Phase IIb outcomes
The overall development plan builds on the successful outcomes of the NATIVE Phase IIb trial CLINICAL CLINICALDEVELOPMENT DEVELOPMENT Phase III in patients with NASH Registration and F2-F3 fibrosis Phase I Phase IIa Phase IIb (NATIVE) III OVERVIEW IIb DESIGN • 72 week Part 1 + Part 2 extension perio
Slide 20: Lanifibranor clinical trial in patients with T2D and NAFLD
Lanifibranor clinical trial in patients with T2D and NAFLD Objective: Demonstrate the efficacy/safety and mechanism of action of lanifibranor in patients with T2D and NAFLD. Specifically determine if lanifibranor decreases intrahepatic triglyceride (IHTG), improves adipose tissue, hepatic and muscle
Slide 21: LEGEND Study Design
LEGEND Study Design PHASE II Lani + SGLT2i Lanifibranor in Combination with the SGLT2 Inhibitor empagliflozin in patients with NASH and Type 2 Diabetes – LEGEND Study Principal investigator Inclusion criteria Prof. M. Lai, gastroenterologist-hepatologist, Adult patients with diabetes and NASH as
Slide 22: Status update of LEGEND
Status update of LEGEND Sites qualification – 36 sites (+ 5 back-up) qualified in 5 countries (Belgium, France, the Netherlands, UK and US) Regulatory submission – Study approved in France and US (CA and EC) – Submission completed in the UK, Belgium and the Netherlands 2022 2023 Phase IIa H1 202
Slide 23: Lanifibranor anticipated clinical readouts
Lanifibranor anticipated clinical readouts CLINICAL READOUTS Patients with Patients with Patients with NAFLD and NASH F2 F3 NASH and T2D T2D fibrosis stage 2022 2023 2024 2025 Clinical readouts Q1 2023 Topline results of the phase II trial of H2 2023 lanifibranor in Topline results of the patients w
Slide 24: Cedirogant - ABBV-157
Cedirogant - ABBV-157 oabobvie
Slide 25: Highlights
Highlights RORγ is believed to be a master regulator of Th17 differentiation and IL-17 expression, an approach validated by several successful biologics We believe RORγ mechanism of action could prove efficacious in psoriasis and other auto-immune diseases We believe substantial commercial opp
Slide 26: Odiparcil - MPS
Odiparcil - MPS
Slide 27: MPS VI is a devastating rare lysosomal storage disorder
MPS VI is a devastating rare lysosomal storage disorder Currently Treated Population Potential for Market Expansion Rare, Hereditary Lysosomal Storage Disorder Oral therapy would significantly There are ~1,000 patients treated • Mucopolysaccharidoses (MPS) is an inherited disorder characterized by t
Slide 28: Summary of key data generated to date
Summary of key data generated to date Odiparcil reduces GAG accumulation in multiple organs in both developing and established disease MPS VI models We believe odiparcil has the potential to become a valuable Penetrates and clears GAGs from difficult-to-reach tissues, treatment option for MPS VI inc
Slide 29: Odiparcil key highlights
Odiparcil key highlights We believe odiparcil has the potential to be a differentiated treatment addressing unmet needs for a life-threatening condition • Potential game changer as the first therapy with the ability to broadly address a wide range of clinical manifestations in MPS VI patients Oral R
Slide 30: MPS VI treatment paradigm
MPS VI treatment paradigm Odiparcil aims at improving the treatment options for both ERT eligible and ineligible patients Current MPS VI Treatment Paradigm ERT-eligible ERT-ineligible 1st Line Naglazyme Palliative Care 2nd Line No Approved Treatments Potential Treatment Paradigm with odiparcil ERT-e
Slide 31: Overview of odiparcil regulatory status
Overview of odiparcil regulatory status EUROPE USA • EMA Scientific Advice Meeting – Jul 2020 • Type C Meeting – August 2022 Overview of • ANSM Scientific Advice Meeting – Apr 2019 • Type C Meeting – Nov 2020 Discussions • MHRA Scientific Advice Meeting – Mar 2019 • P-IND Meeting – Mar 2018 • EMA Sc
Slide 32: Odiparcil potential path to regulatory submission
Odiparcil potential path to regulatory submission The proposed clinical trial design contemplates to enroll 50 pediatric patients for 12 months, potentially leading to filing for odiparcil’s approval as ERT combination therapy in patients 5 y/o to adults Part 1 Potential odiparcil Approval iMProveS
Slide 33: Financials
Financials
Slide 34: Key financials and shareholder base
Key financials and shareholder base Key financials Shareholder base Founders Free Float 22.5% 27.9% ISIN code FR0013233012 / US46124U1079 Employees & Others 2.8% Market Euronext Paris / Nasdaq GM BVF Yheng 19.9% 5.6% Shares outstanding 42,134,169 Sofinnova 8.0% NEA Market cap Euronext Paris: €171m 1
Slide 35: H1 2022 financial position
H1 2022 financial position Highlights Income Statement ► Revenues of €0.1 m, comparable with H1 2021 (in thousands of euros, except share and • Reminder: Inventiva recorded in 2021 P&L a milestone upon the June 30, 2021 June 30, 2020 per share amounts) initiation by AbbVie of the Ph2b clinical trial
Slide 36: Recent and anticipated catalysts
Recent and anticipated catalysts
Slide 37: Recent and anticipated key milestones
Recent and anticipated key milestones Lanifibranor Activation of first clinical sites and start of patient screening in NATiV3 phase III trial in NASH Activation of first clinical sites and start of patient screening in LEGEND phase IIa trial in NASH Signature of licensing and collaboration ag
Slide 38: Q&A
Q&A
Slide 39: Contacts
Contacts Inventiva Brunswick Westwicke, an ICR Company Frédéric Cren Yannick Tetzlaff / Tristan Roquet Montégon Patricia L. Bank / Aude Lepreux CEO Investor relations Media relations [email protected] [email protected] [email protected] +33 (0)3 80 44 75 00 + 33 1 53 96 83 8