Genfit (GNFT) Q2 2024 earnings summary

Executive summary

• Achieved FDA approval and U.S. launch of Iqirvo (elafibranor) for PBC, triggering a €48.7M milestone payment and first royalty revenue from Ipsen.

• EMA positive opinion for Iqirvo in Europe, with a final decision and €26.5M milestone expected in 2H24.

• Strong financial position with €61.6M cash at June 30, 2024, excluding the €48.7M milestone received in August.

Financial highlights

• 1H24 revenues and other income reached €61.2M, up from €15.4M in 1H23, mainly due to the Ipsen milestone.

• Operating expenses decreased to €30.0M from €34.7M year-over-year, driven by lower R&D costs post-FDA approval.

• Net profit of €30.3M in 1H24, compared to a net loss of €20.9M in 1H23.

• Cash and cash equivalents at €61.6M as of June 30, 2024, with additional milestone cash received in August.

• Cash flow from operations improved, with outflow reduced to €11.2M from €25.1M year-over-year.

Outlook and guidance

• Anticipates €26.5M milestone upon Iqirvo's European pricing and reimbursement approval.

• Expects to fund operations through at least Q4 2025, not including exceptional events.

• 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.