Genfit (GNFT) Q2 2024 earnings summary

Executive summary

• Achieved FDA accelerated approval and U.S. launch of Iqirvo® (elafibranor) for PBC, triggering a €48.7M milestone payment and first commercial sales; EMA positive opinion received, with EU approval and €26.5M milestone expected in Q4 2024.

• Revenue surged to €61.2M in H1 2024, mainly from Ipsen licensing milestones and deferred revenue recognition.

• Net profit reached €30.3M, reversing a €20.9M loss in H1 2023, driven by milestone income.

• Strong financial position with €61.6M cash at June 30, 2024, with additional milestone cash received in August.

• R&D focus on ACLF and rare liver diseases, with multiple assets in clinical and preclinical stages.

Financial highlights

• H1 2024 revenue: €61.2M (vs. €15.4M in H1 2023), with €48.7M from Ipsen milestone.

• Net profit: €30.3M (vs. €20.9M loss in H1 2023).

• Operating expenses decreased to €30.0M (from €34.7M), mainly due to lower R&D costs post-FDA approval.

• Cash and cash equivalents: €61.6M at June 30, 2024 (vs. €77.8M at Dec 31, 2023), with additional milestone received in August.

• Operating cash outflow: €11.2M (improved from €25.1M outflow in H1 2023).

Outlook and guidance

• Cash runway expected through at least Q4 2025, assuming receipt of future milestones and EU launch of Iqirvo®.

• Anticipates €26.5M in additional milestones upon EU approval of Iqirvo®.

• Focus on advancing clinical programs (VS-01, NTZ, GNS561) and strengthening ACLF leadership; interim Phase 2 data for VS-01 in ACLF targeted for 2H24.

• NTZ Phase 2 and SRT-015 first-in-human studies planned for 2025; GNS561 Phase 1b/2a in cholangiocarcinoma ongoing, with preliminary data expected by end of 2024.