ENANTA PHARMACEUTICALS INC Q4 FY2022 earnings call

• COVID-19: EDP-235 advanced to Phase 2 SPRINT trial for COVID-19, a randomized double-blind, placebo-controlled study enrolling ~200 non-hospitalized symptomatic patients. Phase I data showed EDP-235 was safe and well-tolerated, with strong exposure multiples over EC90.
• RSV: Progress with EDP-938 in Phase 2b RSV HR study in high-risk adults and EDP-323 in Phase 1 study in healthy adults. EDP-323 has promising preclinical data.
• Human Metapneumovirus: Presented preclinical data on detection, quantification, and growth methods for better in vitro characterization.
• Hepatitis B: Focus on developing combination therapy with EDP-514 to achieve a functional cure.
• Near-term milestones: Aim to report SPRINT results in first half of 2023 and Phase 1 data for EDP-323 in first half of 2023.

For the fiscal fourth quarter ended September 30, 2022, total revenue was $20.3 million, consisting of royalty revenue from AbbVie's global MAVIRET net product sales. This is down from $23.6 million in the same period of 2021. Research and development expenses for the quarter were $34.8 million, a decrease from $48.9 million in 2021, primarily due to timing and scope of clinical trials. General and administrative expense was $12.6 million, up from $8.4 million in 2021, due to additional headcount and stock compensation. Enanta ended the quarter with approximately $278.5 million in cash and marketable securities.

• Fiscal 2023 research and development expense expected to be between $210 million to $230 million.
• Fiscal 2023 general and administrative expense expected to be between $46 million to $52 million.
• Current cash and marketable securities expected to cover anticipated cash requirements into Q4 2024.

• Uncertainty in COVID-19 variant evolution affecting trial outcomes and regulatory pathways.
• Risks related to clinical trial enrollments and data interpretation in diverse patient populations.
• Uncertainties in identifying optimal combination therapies for hepatitis B.

Q: Brian Abrahams from RBC Capital Markets asked about key virological measures for EDP-235's SPRINT study and accounting for patient variability.

A: Jay Luly discussed controlling variables like vaccination status, focusing on safety/tolerability as primary endpoint, and looking at viral load as a key virological measure while noting exploratory symptoms assessment.

Q: Yasmeen Rahimi from Piper Sandler inquired about next steps post-SPRINT for EDP-235 and data scenarios for EDP-323.

A: Jay Luly stated next step after SPRINT would be Phase III, and for EDP-323, Phase 1 data will guide next steps like challenge studies or patient populations.

Q: Brian Skorney from Baird asked about dose response on viral load for EDP-235, viral load measurement methods, and enrollment days for SPRINT.

A: Tara Kieffer explained they'll look at both RNA and infectious viral load via PCR and culture, and enrollment within 5 days of symptom onset to capture relevant patients.

Q: Liisa Bayko from Evercore ISI questioned the goal of the COVID study focusing on low-risk patients and study objectives.

A: Jay Luly explained standard risk patients have similar viral loads to high-risk, and safety/tolerability can be assessed adequately in this population, with Phase III to broaden outcomes.

Q: Eric Joseph from JPMorgan asked about viral rebound with Pfizer's paxlovid and RSV combination potential.

A: Jay Luly discussed viral rebound and EDP-235's potential tissue uptake to address it, and for RSV, challenge studies could explore combination potential of EDP-938 and 323.

Q: Roanna Ruiz from SVB Securities asked about clinical symptoms analysis in SPRINT and RSV study enrollments.

A: Tara Kieffer mentioned they'll look at all symptoms with ability to analyze specific subsets, and Jay Luly noted balanced enrollment in RSV studies with caps on certain patient populations.

Q: Jay Olson from Oppenheimer asked about regulatory approval timeline for EDP-235 and combination plans for EDP-514.

A: Jay Luly discussed uncertain regulatory timeline based on variant evolution, and for EDP-514, they're seeking optimal combination therapies internally and externally.

Q: Roy Buchanan from JMP Securities asked about 235 tissue uptake data timing and funding for 235 Phase 3.

A: Jay Luly stated 235 tissue uptake data not this year, and Phase 3-related costs are included in R&D guidance as they're being incurred conservatively.