IVA — Inventiva S.A.

Summary of Inventiva (IVA) Q4 2024 Earnings Call

1. Key Financial Results and Metrics:

• Cash Position: Ended 2024 with €96.6 million, up from €36 million at the end of 2023, reflecting a net increase of approximately €61 million.
• Revenue: Recorded revenues of €9.2 million, down from €17.5 million in 2023, primarily due to milestone payments from CTTQ.
• R&D Expenses: Totaled €19.9 million, a decrease of 17% from €110 million in 2023, attributed to operational delays.
• Net Loss: Reported a net loss of €184.2 million, compared to €110.4 million in 2023, largely due to non-cash financial losses related to fair value adjustments and interest.
• Cash Runway: Guidance indicates operational capacity until September 2025, extending to September 2026 with anticipated financing.

2. Strategic Updates and Business Highlights:

• Clinical Development: Significant progress in the Phase 3 NATiV3 trial for lanifibranor, with recruitment expected to complete in H1 2025. Positive recommendations from data monitoring committees were received.
• Regulatory Strategy: Focused on preparing for regulatory submissions and commercialization of lanifibranor, with a strong emphasis on enhancing the development team.
• Partnerships: Hepalys initiated a Phase 1 study in Japan, with clinical development financed entirely by the partner, minimizing financial impact on Inventiva.
• Board Expansion: Three new board members were appointed to strengthen governance and strategic direction.

3. Forward Guidance and Outlook:

• Enrollment Completion: High confidence in completing patient enrollment by April 2025, which is critical for securing a €116 million capital increase.
• NDA Filing: Plans to file for NDA in the first half of 2027, with an outcome study underway as per FDA guidelines.
• Market Positioning: Positioned as the only oral drug in Phase 3 for MASH, with expectations for strong commercial interest post-enrollment completion.

4. Bad News, Challenges, or Points of Concern:

• Workforce Reduction: A strategic decision to cut approximately 50% of the workforce due to a shift in focus solely on lanifibranor, which may impact morale and operational capacity.
• Revenue Decline: Significant drop in revenue year-over-year, raising concerns about financial sustainability without new funding or successful product launches.
• Increased Net Loss: A substantial increase in net loss raises questions about cost management and operational efficiency moving forward.

5. Notable Q&A Insights:

• Combination Studies: There are no plans for fixed-dose combinations of lanifibranor with SGLT2 inhibitors, but data supporting their combination use is being generated.
• Market Dynamics: The approval of competitors like Madrigal has increased interest in the MASH market, with Inventiva confident in lanifibranor's potential efficacy and market fit.
• Financing Strategy: Active discussions regarding additional financing options are ongoing, with a focus on securing partnerships post-enrollment to enhance market entry prospects.

Overall, Inventiva is at a pivotal point with promising clinical developments for lanifibranor, but faces significant financial challenges and operational adjustments that could impact its trajectory.