Atea Pharmaceuticals (AVIR) investor relations material

Program updates and clinical trial results

• Achieved primary endpoint in phase III U.S. trial for hepatitis C, showing non-inferiority to EPCLUSA with an eight-week regimen and strong efficacy and safety profile.

• Ex-U.S. C-FORWARD trial is fully enrolled, with data expected early Q1 next year, focusing on broader genotypes and global populations.

• C-FORWARD is designed to confirm C-BEYOND results, with aligned endpoints and statistical plans, and is expected to show robust efficacy, especially in genotype 3.

• Both trials target non-cirrhotic and cirrhotic patients, with the majority of U.S. patients being non-cirrhotic.

• NDA filing with the FDA is anticipated for mid-next year, with EMA submission planned for late 2027.

Market landscape and commercial strategy

• U.S. hepatitis C market has about 4 million infected, with 160,000 new cases annually and only half treated.

• Market research shows over 80% of top prescribers are interested in the new regimen due to its short duration and low drug-drug interaction risk.

• Sales force will target fewer than 8,000 physicians who write 80% of prescriptions, with a planned team of around 100.

• The competitive landscape is split between two main regimens, each with about 50% share; a third entrant typically captures 30–35%.

• The test-and-treat model is expected to increase treatment rates, with federal initiatives likely in the next five years.

Regulatory, pricing, and partnership plans

• Label expected to reflect eight-week regimen for non-cirrhotic and 12 weeks for cirrhotic patients, with minimal drug-drug interactions and pangenotypic coverage.

• Pricing will be competitive with current market leaders.

• Ex-U.S. commercialization will be through partnerships, with negotiations to begin after C-FORWARD data and FDA filing.

• EMA and other major market filings are planned, except for Japan, where partnership discussions are ongoing.