Inventiva S.A. Q2 FY2021 earnings call

• Lanifibranor: Phase 3 study started, qualified over 330 sites in 25 countries, received Breakthrough Therapy and Fast Track designations from FDA, nonclinical toxicology package complete for NDA filing.
• Cedirogant: AbbVie posted Phase 2b design for psoriasis study, to start in Nov 2021, potential milestone payment for Inventiva.
• Odiparcil: Strategy evaluation ongoing, update expected in 2022.
• Team and cash reinforcement: Reinforced team in US and France for Phase 3, set up ATM for cash flexibility, Board reinforced with Martine Zimmerman's regulatory expertise.

No detailed financial performance by product segments with absolute terms and revenue contribution % provided in the transcript.

• Lanifibranor Phase 3 study ongoing with results anticipated.
• Cedirogant Phase 2b study to start in Nov 2021, results scheduled for Mar 2023.
• Odiparcil update expected in 2022.
• ATM provides flexibility to reinforce cash position with up to $100 million exercise possibility.

• Uncertainty in odiparcil strategy evaluation timeline.
• Potential challenges in patient recruitment for lanifibranor Phase 3 study.
• Dependence on AbbVie's successful development of cedirogant for milestone and royalty receipts.

Q: On the anticipated AbbVie milestone, should it be in a similar ballpark to previous milestone or more? And insights on recruitment status of Prof. Cusi study and safety concerns with ROR-gamma?

A: Milestones are relatively small, royalties from cedirogant could be significant. Recruitment for Cusi study is investigator-led by Prof. Cusi. ROR-gamma safety profile differs from JAK class with less severe side effects.

Q: Potential patient recruitment for lanifibranor Phase 3, visibility on broader clinical development, and delay in odiparcil strategic review?

A: NASH has screening failure rates, efforts to reduce them. Broader clinical development includes combo studies and F4 evaluation. Odiparcil strategic review delayed due to need to meet objectives of patient need and financial gain.

Q: Thoughts on ongoing Phase 2 in Type 2 diabetes, combo studies mechanism, and differences in NATiV3 study?

A: Phase 2 in Type 2 diabetes provides mechanistic data. Combo with SGLT-2 inhibitors has rationale. NATiV3 study has longer treatment duration and focuses on F2/F3 patients with strong fibrosis effect seen in shorter treatment.

Q: Future development for lanifibranor regarding doses, sites, and differentiation?

A: Too soon to project doses for combo or F4. Sites have ongoing studies, lanifibranor's efficacy on multiple endpoints and once-daily administration differentiate it.

Q: Questions on AbbVie development, lani recruitment communication, odiparcil strategic review, and YAP-TEAD pipeline?

A: AbbVie in control of cedirogant development. Lani recruitment updates to be communicated as required. Odiparcil strategic review evolves with competition and FDA meetings. YAP-TEAD pipeline involves oncology targets with ongoing portfolio comparison.

Q: ATM usage, partnership discussions, cedirogant vs other compounds, and R&D expense projection?

A: Not decided to use full $100M ATM, Phase 3 likely funded. Partnership discussions ongoing for NASH. Cedirogant has role as oral drug. R&D expenses to slightly increase in 2022 with full annual basis of U.S. operations.