Inventiva S.A. Q2 FY2022 earnings call

Partnerships and Pipeline Updates

• Signed partnership with Sino Biopharm for lanifibranor in Greater China, with upfront, milestones, and royalties involved. Sino Biopharm is a large Chinese pharmaceutical group with strong clinical, manufacturing, and sales capabilities.
• Lanifibranor (Phase III NASH drug): Expanded to 24 countries with 300+ sites activated, but recruitment delay in NATiV3 trial due to higher-than-expected screening failures. LEGEND study (lanifibranor + empagliflozin) ongoing, with topline results expected in H2 2023.
• Cedirogant (ABBV-157): Phase IIb psoriasis trial expected results in H1 2023; AbbVie has plans for Phase III if successful.
• Odiparcil: Positive FDA feedback allows direct entry into pediatric MPS VI (5-14 years) with a single Phase II/III trial potentially supporting marketing approval.

Financials

• Reinforced cash position via At-The-Market program (€15M), state-backed financing, and EIB loan (€50M). Cash runway extended to Q4 2023 with Sino Biopharm upfront and EIB first tranche.

No detailed product segment performance with revenue contribution provided in the transcript.

Clinical Timelines

• Q1 2023: Results from Cusi's study on lanifibranor in type 2 diabetes and NAFLD.
• H2 2023: Topline results from LEGEND study (lanifibranor + empagliflozin) and cedirogant Phase IIb psoriasis trial.
• H2 2025: Topline results from Part 1 of NATiV3 trial.

Partnership Impact

• Potential acceleration of lanifibranor development in China via Sino Biopharm's capabilities.

Risks Identified

• High screening failure rates in NATiV3 trial impacting recruitment timelines.
• Market uncertainties and competition in NASH and autoimmune drug spaces.
• Dependence on regulatory approvals and successful clinical trial outcomes for drug pipelines.

Q: Comparison of Inventiva's data vs Akero's, impact on timeline if Sino joins NATiV3, funding gap.

A: Frédéric noted Akero's data used per protocol vs ITT, and Inventiva's data is on ITT; Philip discussed potential quick enrollment if Sino joins NATiV3; Frédéric mentioned funding via ATM, partnerships, and non-dilutive sources.

Q: NASH interest, non-invasive diagnostics, NASH size in China.

A: Michael and Frédéric/Philip discussed positive sentiment in NASH space, progress in non-invasive diagnostics, and large market potential in China due to high NASH prevalence.

Q: Screening failure rates in NATiV3, AbbVie's plan for cedirogant data.

A: Frédéric discussed measures to reduce screen failures, and noted AbbVie's potential data release timeline for cedirogant.

Q: Sino Biopharm's experience, EIB financing conditions.

A: Philip discussed Sino Biopharm's experience in global trials, and Jean explained EIB financing conditions and milestones for second tranche.