Atea Pharmaceuticals Conference Call Summary Company Overview - **Company**: Atea Pharmaceuticals (NasdaqGS:AVIR) - **Event**: FY Conference on January 15, 2026 - **Focus**: Updates on bemnifosbuvir and ruzasvir for Hepatitis C treatment and new Hepatitis E program Key Points on Hepatitis C Treatment - **Phase 3 Program**: Atea is executing a global phase 3 program for Hepatitis C, with pivotal data expected in mid-2026 [2][3] - **Enrollment**: Over 900 patients enrolled in the North American trial, with completion expected by the end of Q2 2026 [3][4] - **NDA Filing**: Anticipated filing of a New Drug Application (NDA) with the FDA in Q1 2026 [4] - **Efficacy**: The regimen shows a 98% efficacy cure rate in phase 2 studies, with a focus on a short treatment duration of 8 weeks [9][32] - **Market Dynamics**: Despite the introduction of effective treatments, the number of Hepatitis C infections in the U.S. has increased from 2.5 million to over 4 million in the last decade [6][28] - **Commercial Opportunity**: The global Hepatitis C market is approximately $3 billion, with the U.S. accounting for about 50% [34] Insights on Hepatitis E Program - **Target Population**: Focus on immunocompromised patients, particularly those undergoing solid organ transplants [4][22] - **Market Potential**: Estimated 450,000 patients annually in the U.S. and Europe, with a potential billion-dollar market opportunity [23] - **Treatment Development**: Atea is advancing a new candidate, 80587, for Hepatitis E, with IND-enabling studies underway [21][25] Financial Position - **Cash Reserves**: Atea has over $300 million in cash and investments, providing a runway through 2027-2028 [5] - **Cost of Goods**: Anticipated low single-digit costs related to net pricing, with expectations for profitability within 24 months post-launch [21] Industry Context - **Infection Trends**: The opioid crisis has contributed to a rising number of Hepatitis C infections, with an estimated 160,000 new infections annually in the U.S. [28] - **Test-and-Treat Model**: A proposed model to enhance screening and treatment access, particularly for younger populations at risk [30][31] Regulatory and Clinical Considerations - **Regulatory Strategy**: Atea is preparing for potential differences in regulatory requirements between the FDA and EMA [17][19] - **Clinical Trial Design**: Emphasis on robust trial designs to ensure sufficient power and efficacy comparisons against standard treatments [19][20] Conclusion - **Pivotal Year**: 2026 is positioned as a critical year for Atea, with significant milestones in both Hepatitis C and E programs expected [26][27]