Inventiva S.A. Q4 FY2021 earnings call

Key managerial messages include: Lanifibranor had the NATiV3 Phase III pivotal study started, the LEGEND study (combination with empagliflozin) design announced, and positive FDA interactions. Cedirogant saw AbbVie moving forward with the Phase IIb trial in psoriasis. Odiparcil is preparing for an FDA meeting on pivotal trial design. Financials showed revenues from AbbVie milestone, R&D expense doubled, G&A increased 31%, and cash runway around 1 year. The company opened an US office, reinforced the team, and reinforced the board.

The company's segments include lanifibranor, cedirogant, and odiparcil. For lanifibranor, they received FDA feedback on the tox package, completed a QT/QTc study, and initiated the Phase III NATiV3 study. Milestones from AbbVie contributed to revenues. R&D expense for lanifibranor doubled in 2021 compared to 2020. Cedirogant is in the Phase IIb trial with AbbVie, having triggered a 4 million milestone. Odiparcil is preparing for an FDA meeting to validate the pivotal trial design for finding a new home.

Forward-looking guidance includes: Topline results of Dr. Cusi's study for lanifibranor in the second half of 2023, cedirogant Phase IIb results in early 2023, LEGEND trial topline results in the second half of 2023, and NATiV3 Phase III results in the second half of 2024. Odiparcil continues to prepare for the FDA meeting to find a new home.

Risks discussed include: Impact of Ukraine/Russia sites on NATiV3 trial recruitment, potential delays in clinical trials due to geopolitical issues, and the need for additional funding to support ongoing clinical trials.

Q: On cash runway, LEGEND trial budget, remaining milestones from AbbVie, and Phase III recruitment impact from Ukraine/Russia.

A: Cash runway includes LEGEND trial budget. Remaining milestones to be detailed in filings. Ukraine/Russia sites paused, but additional sites being activated.

Q: On empagliflozin rationale, collaboration for lanifibranor, and future of other products.

A: Empagliflozin rationale based on clinical data. Lanifibranor open to partnership, cedirogant fully with AbbVie, Odiparcil seeking new home.

Q: On ROR gamma program, Phase I proof and future indications.

A: AbbVie confident in Phase IIb based on Phase Ib data (not public), potential indications include rheumatoid arthritis, spondylitis colitis.