Atea Pharmaceuticals, Inc. Q3 FY2024 earnings call

Key Points

• Team executed two large global clinical programs on time and budget, but SUNRISE-3 had unfavorable outcome due to COVID-19 variants and milder disease.
• Concentrated on HCV program, on track to report Phase II top line results in early December, plan end of Phase II meeting with FDA early next year, and initiate Phase III shortly after.
• HCV patient profile in US shifted to younger individuals with substance abuse and comorbidities; current treatments have limitations.
• HCV Phase III-Ready program is derisked with manufacturing ready, clear regulatory pathway, and IP protection until 2042.
• Phase II HCV study nearing completion, leading cohort data shows high SVR12 rate, rapid viral load reduction, and safe/tolerated profile.
• Financials: R&D expenses changed due to COVID-19 vs HCV trial, G&A expenses decreased, interest income down, cash balance $482.8M as of Q3 2024, runway into 2027.

No detailed product segment financial performance with revenue contribution percentages provided. Focus is on HCV program and R&D activities.

Forward-Looking Statements

• Anticipate top line results from Phase II HCV study in early December.
• Expect cash runway to extend well into 2027 with current financial position.
• Plan to initiate HCV Phase III program early next year.

Risks

• Forward-looking statements involve risks and uncertainties outlined in press release and SEC filings.
• COVID-19 variants evolving could impact clinical trial outcomes.
• Patient adherence issues and comorbidities may affect HCV treatment efficacy.

Q: How are you thinking about the Phase III HCV trial design, particularly in the context of any remaining adherence obstacles and the use of an active comparator. And additionally, what parameters are you seeking clarity on going into your meeting with the FDA?

A: Arantxa Horga stated they are planning randomized trials to address adherence, and their Phase III plan is aligned with FDA guidelines.

Q: You've mentioned the drug exposure of fixed dose combination is comparable to individually administered drug. But have you seen any change in the PK profile for each drug component, especially in its half-life?

A: Jean-Pierre Sommadossi stated no change in PK profile, including half-life of both drugs.

Q: Is it going to be the same dose, like 550-milligram BEM and 180-milligram ruzasvir? And I see there's only one site in Phase II U.S. site will be the same like most of the site for Phase III also ex U.S.

A: Arantxa Horga responded that Phase III will have many U.S. and ex-U.S. sites, and the dose will remain the same, with fixed dose combination aiding adherence.

Q: Just given the active control, I'm just curious if you're shooting for perhaps superiority or noninferiority with a numerical benefit from the SVR12 perspective?

A: Andrea Corcoran stated the trial will be powered for noninferiority, with potential for superiority testing based on FDA feedback.

Q: Could potentially be a low-hanging fruit, just basically provide drugs and the other entity would have to identify patients, making this pathway very cost efficient. I'm just wondering how you think about that segment of the market and how much you'll utilize these types of framework.

A: John Vavricka responded that government is a major payer, traditional pathways are stable, and the market is concentrated with efficient prescribing pathways.