Enanta Pharmaceuticals, Inc. Q4 FY2023 earnings call

• RSV Program: EDP-938 in Phase 2 studies (RSVPEDs in pediatrics, RSVHR in high-risk adults) with topline data expected in Q3 2024. EDP-323 Phase 2a challenge study initiated, data expected in Q3 2024. Combination of EDP-938 and EDP-323 has additive/synergistic activity. - Hepatitis B: EDP-514 as core inhibitor with Fast Track, need for additional mechanism in combination. - Business Adjustments: Reduced 2024 spending, extended cash runway to 2027. Stopped RSVTx Phase 2 study, paused hMPV/RSV dual-inhibitor program.

For the fiscal fourth quarter ended September 30, 2023, total revenue was $18.9 million, consisting of royalty revenue from AbbVie's MAVYRET. For the fiscal year ended September 30, 2023, total revenue was $79.2 million. Research and development expenses for Q4 2023 were $36.2 million, compared to $34.8 million in Q4 2022. For the fiscal year, R&D expenses were $163.5 million vs. $164.5 million in 2022. General and administrative expenses for Q4 2023 were $13.8 million vs. $12.6 million in Q4 2022, and for the year, $52.9 million vs. $45.5 million in 2022. Net loss for Q4 2023 was $28.1 million, and for the year, $133.8 million.

• Fiscal 2024 R&D expense expected to be between $100 million and $120 million. - Fiscal 2024 general and administrative expense expected to be between $45 million and $50 million. - Current cash and marketable securities expected to suffice through fiscal 2027.

• Risks related to RSV seasonality affecting study enrollment and data timing. - Uncertainty in clinical trial outcomes for RSV programs. - Patent litigation risks impacting general and administrative expenses.

Q: Asks about RSV program EDP-323 challenge study, potential Phase 3 progression and measures.

A: Jay Luly discusses aiming to report Q3 2024 data, considering study results and positioning in market.

Q: Asks about dual-inhibitor program pause.

A: Jay Luly states pause due to prioritizing advanced RSV trials.

Q: Asks about 323 challenge study expected improvements.

A: Jay Luly explains looking for virology and symptom AUC reductions similar to EDP-938.

Q: Asks about non-virology disease areas.

A: Jay Luly says will discuss early 2024.

Q: Asks about Phase 2 RSV high-risk study and prior immunization.

A: Jay Luly mentions less than 5% adult immunization, Scott Rottinghaus says not studying vaccinated patients in current study.

Q: Asks about runway guidance and 938/323 development.

A: Jay Luly discusses advancing both agents, focusing on key activities.

Q: Asks about 938 study data timing and endpoints.

A: Jay Luly talks about waiting for Northern Hemisphere season, looking for virologic trends.

Q: Asks about GLP-1 space.

A: Jay Luly says not discussing new areas today.

Q: Asks about RCPs and FDA discussions.

A: Jay Luly talks about study structure and challenges in COVID-related registrations