How to eliminate refill requirements for the test-and-treat model, especially after the first month, given payer or other stakeholder rules?

Management indicated that they don't have a definitive answer for eliminating refill requirements across the board. However, in states where test-and-treat is practiced, payers have allowed physicians to provide the full appropriate amount of medication without a refill. They highlighted BAM-RZR's profile as ideal for test-and-treat due to fewer drug-drug interactions and shorter therapy duration. “in talking with physicians who do practice test and treat within their respective states, the payers for those respective states have allowed them to give the appropriate amount without a refill to those patients.”

What is the process and timeline for BAM-RZR to be included in the AASLD guidelines, and what evidence from C-Beyond and C-Forward will be most important?

Management believes BAM-RZR's best-in-class profile, offering an 8-week duration for most patients, will facilitate inclusion in treatment algorithms once approved and labeled. They are receiving excellent feedback from principal investigators. Jean-Pierre also noted the remarkable speed of enrollment for both C-Beyond and C-Forward, indicating high demand. “I think what they are looking for is best-in-class profile. So this is what we are offering here. It's the eight-week for the majority of the patients. And once they see these results, and we obviously get a label and an approval, I think I think that it will not be difficult with this profile to get it into treatment algorithms.”

How does the C-Beyond non-inferiority result impact confidence for C-Forward's Q1 2027 readout, and how comparable are the baseline characteristics expected to be given different geographies and genotype mix?

Management expressed confidence, noting that while C-Forward's primary endpoint for EMA is per-protocol, the FDA's primary endpoint will be MITT, similar to C-Beyond. They expect C-Forward to have a different genotype mix (more 1Bs and rare genotypes) and a more adherent patient population ex-US, potentially closer to Phase 2 results. “for the C4 word, We are more likely to see genotypes, obviously, that are not in the United States. So the United States predominantly is 1A. Ex-U.S., we're going to be seeing more of the 1Bs. And then some of the rare genotypes that we made an extraordinary effort to get, genotypes which are not common in the United States.”

AVIR

Atea Pharmaceuticals (AVIR) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 12, 2026

Source: earnings call transcript

Executive summary

Atea Pharmaceuticals Q2 FY26 — Positive Phase 3 C-Beyond Results and Pipeline Advancement

Atea Pharmaceuticals reported positive Phase 3 C-Beyond trial results for its hepatitis C regimen, BAM-RZR, demonstrating non-inferiority to the standard of care and reinforcing its potential best-in-class profile for a complex patient population. The company is advancing its C-Forward trial and a novel hepatitis E program, while maintaining a solid financial position. Management believes BAM-RZR is uniquely positioned to expand the HCV market by addressing treatment barriers and capturing untreated patients, targeting a mid-2028 launch.

Highlights

Positive top-line results from the Phase 3 C-Beyond trial for BAM-RZR, meeting primary and secondary endpoints with 93.9% SVR rate, demonstrating non-inferiority to standard of care.
C-Forward Phase 3 trial fully enrolled with over 880 patients, on track for top-line results in early Q1 2027.
Initiated first-in-human Phase 1 clinical trial for AT587, a potential first-in-class direct-acting antiviral for chronic Hepatitis E.
Strong financial position with $219.5 million in cash and marketable securities as of June 30, 2026, with cash runway anticipated through 2027.
Anticipated peak annual U.S. net revenue potential in excess of $700 million for BAM-RZR, with market expansion potential up to $2.5 billion annually.

Concerns

The HCV market is often perceived as declining by Wall Street, despite a widening gap between new infections and treated patients, posing a challenge for market perception.
Current SVR rates with approved therapies can fall as low as 74% among people who injected drugs, highlighting ongoing treatment adherence and access barriers in the real world.

Guidance & targets

Category	Target	Timeline	Confidence
C-Forward Phase 3 Top-line Results	early Q1 2027 high materiality	Q1 · FY27	High
Cash Runway	through 2027 medium materiality	FY27	High
NDA Submission (BAM-RZR)	second quarter of 2027 high materiality	Q2 · FY27	High
Hepatitis E Program Proof of Concept	2027 medium materiality	FY27	Medium
BAM-RZR Launch	mid-2028 high materiality	mid-CY28 · FY28	High
BAM-RZR Peak Annual U.S. Net Revenue Potential	in excess of $700 million high materiality	Peak	High

Risks & headwinds

Perception of declining HCV market Current

Wall Street often looks at revenue trends for approved HCD therapies and concludes that this is a declining market.

Mitigation:Company highlights growing infected population (moving towards 4 million in US) and widening gap between infections and treatment as an expanding addressable market, positioning BAM-RZR to capture untreated patients and grow the market.

Real-world adherence and discontinuation in HCV treatment Current

SDR rates with approved therapies can fall below the rates reported 10 years ago in the original pivotal studies, including rates as low as 74% among people who injected drugs.

Mitigation:BAM-RZR's profile (short 8-week duration, protease inhibitor-free, low DDI) is designed to address these barriers and improve treatment completion.

Impact of pricing reforms (Inflation Reduction Act, Medicare Part D, 340B) Ongoing

Inflation Reduction Act has had an effect on manufacturers with higher Medicare patient percentages. Could affect Medicaid discounts. Proposed 340B changes could be favorable by shifting to rebate mechanism.

Mitigation:Management notes that pricing differential between US and EU for HCV drugs is not as dramatic as for other pharmaceuticals, and some manufacturers are already cutting direct deals with state Medicaid agencies.

What to watch in Q3 FY26

C-Forward Phase 3 Top-line Results

early Q1 2027

Current Fully enrolled (880+ patients)

Target Positive top-line results

Why it matters

Confirmatory efficacy data across broader genotypes is crucial for a broad pangenotypic label and global regulatory package.

We remain on track to report top-line results in early Q1, 2027.

Find out whether AVIR delivers this. Inve re-checks your case every morning.

Q&A highlights

How will the new MOA be incorporated into the label, and what steps are needed to fully implement the test-and-treat model with the blister pack given payer requirements for refills?

Management stated that the full dataset on the new MOA will be shared with the FDA early next year and presented at scientific meetings. For test-and-treat, while blister packs are for convenience, the quantity given depends on payer allowances in specific states. Physicians implementing test-and-treat have seen success and are excited about BAM-RZR's profile due to fewer DDI and shorter course.

“We anticipate to share with the FDA early next year when we'll have the full dataset. So it's a little bit early for me to discuss about it, but obviously we will present at scientific meetings and share with the FDA with the impact that we believe that this supplemental important MOA for them and totally unique.”

asked by Andy Shea · answered by Jean-Pierre Sommadossi

2 min read 6 chapters

Detailed narrative

C-Beyond Phase 3 Trial Success

Atea announced positive top-line results from its C-Beyond Phase 3 trial for BAM-RZR in North America, demonstrating statistical non-inferiority to the current standard of care, Eclusa. The trial met both primary and secondary endpoints, achieving a 93.9% SVR rate for BAM-RZR compared to 94.8% for Eclusa at week 24 in the MITT population, within the pre-specified 5% non-inferiority margin.

This success is significant as it was conducted in a real-world patient population with high comorbidities and adherence challenges.

C-Forward Phase 3 Trial Progress

The second Phase 3 trial, C-Forward, being conducted outside North America to enable a broad pangenotypic label, is fully enrolled with over 880 patients. Top-line results are expected in early Q1 2027. This trial is enriched for genotypes 1B, 3, 4, 5, and 6, and will provide confirmatory efficacy data across a broader range of genotypes, strengthening the regulatory package for BAM-RZR.

AT587 Hepatitis E Program Advancement

Atea initiated its first-in-human Phase 1 clinical trial for AT587, a potential first-in-class direct-acting antiviral for chronic hepatitis E, a serious disease with no approved treatment. The study is being conducted in healthy volunteers to evaluate safety, tolerability, and pharmacokinetics, with the first cohort already completed. This program represents a meaningful pipeline beyond hepatitis C.

HCV Market Opportunity and Commercial Strategy

Management highlighted a widely misunderstood dynamic in the HCV market, where early diagnosed infections continue to outpace treated patients, leading to a growing addressable market of nearly 4 million people in the U.S. They believe BAM-RZR's profile, with its short 8-week duration for non-cirrhotic patients, protease inhibitor-free composition, and low drug-drug interaction potential, is optimal for the emerging "test and treat" model of care.

Commercial Readiness and Market Potential

Atea is advancing commercial readiness activities, including manufacturing and packaging. Market research indicates strong uptake potential, with 76% of high-volume DAA prescribers extremely likely to prescribe BAM-RZR. The company projects peak annual U.S. net revenue potential in excess of $700 million, contributing to a potential market expansion of up to $2.5 billion annually in the U.S.

Financial Position and Discipline

The company reported a solid financial position with $219.5 million in cash and marketable securities as of June 30, 2026. They anticipate a cash runway through 2027, with spending primarily focused on advancing the Hepatitis C program and pre-launch activities.

R&D expenses increased in the first six months of 2026 due to the Phase 3 HCV program and HEV preclinical/clinical startup, while G&A decreased due to lower salaries and stock-based compensation.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.