AC Immune (ACIU) Q4 2023 earnings summary

Executive summary

• Advanced three active immunotherapy programs in Phase 2; key 2024 readouts include ACI-24.060 amyloid PET data and ACI-7104.056 safety and immunogenicity updates.

• ACI-24.060 received FDA Fast Track designation; ACI-35.030 entered a partner-led Phase 2b trial in preclinical AD.

Financial highlights

• Contract revenue rose to CHF 14.8m in 2023 from CHF 3.9m in 2022, primarily from the ACI-35.030 Phase 2b commencement milestone.

• Operating loss narrowed to CHF 53.6m from CHF 70.8m; net loss after tax was CHF 54.2m vs. CHF 70.8m in 2022.

• R&D expenses decreased to CHF 54.6m from CHF 60.3m; G&A expenses fell to CHF 15.3m from CHF 15.8m.

• Other operating income was CHF 1.5m in 2023, including CHF 1.4m of grant income for R&D activities.

Outlook and guidance

• ACI-24.060 six-month Abeta-PET results are expected in Q2 2024 and 12-month results in H2 2024; results may inform advancement toward a registrational program.

• ACI-7104.056 interim safety and immunogenicity updates from the VacSYn Phase 2 trial are expected in H2 2024.

• ReTain Phase 2b first-patient initiation was expected in H1 2024; TDP-43 PET Phase 1 initiation was expected in H2 2024.

• Cash resources were expected to fund operations into at least Q1 2026, assuming receipt of a CHF 24.6m ACI-35.030 milestone in 2025 and no other milestones.