Financial Data and Key Metrics Changes - Invivyd reported a significant increase in Pemgarda revenues, which grew by 11% quarter on quarter and 41% year over year, reflecting ongoing market awareness efforts [18] - The company raised approximately $87 million in capital during the quarter, enhancing its financial position to support pivotal clinical programs and commercial expansion [5][18] Business Line Data and Key Metrics Changes - The Pemgarda commercial franchise is expanding, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion, with 76% of those accounts reordering [13][14] - The company is transitioning from a smaller patient population to a broader market with the potential approval of VYD2311, which is expected to replace vaccines for COVID prevention [12][17] Market Data and Key Metrics Changes - The U.S. COVID vaccine market generated $3.8 billion in sales last year, but vaccine uptake remains lower than that of influenza vaccines, despite higher public concern about COVID [17] - The company sees a significant opportunity to improve safety and efficacy in COVID protection compared to existing vaccines, which may enhance market share if VYD2311 is approved [17] Company Strategy and Development Direction - Invivyd is focused on advancing its next-generation antibody, VYD2311, which aims to provide a safer and more effective alternative to current COVID vaccines [4][11] - The company is preparing for pivotal studies, with data expected in mid-2026, and is committed to maintaining operational discipline while expanding its commercial organization [5][11][18] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of addressing the long-term efficacy and safety of COVID vaccines, noting the lack of modern randomized data on vaccine effectiveness [9][10] - The next 12 to 18 months are anticipated to be transformative for Invivyd, with a strong focus on clinical trials and potential market entry for VYD2311 [6][11] Other Important Information - The company is conducting studies to evaluate the safety and efficacy of VYD2311, including a head-to-head comparison with mRNA vaccines to address safety concerns among the public [10][11] - Invivyd is also exploring early-stage discovery efforts in RSV and measles, aiming to differentiate its products in these markets [29][30] Q&A Session Summary Question: Will Invivyd wind down Pemgarda once the next-gen product is approved? - Management confirmed that there are no plans to actively sunset Pemgarda, as it remains a differentiated medicine despite its scalability challenges [20][21] Question: Can you clarify the coordination between CBR and CDR for the Liberty study? - Management indicated that coordination between CBER and CDER is expected, but specific details would be best addressed by the FDA [22][23][25] Question: What are the commercial team's current reach and plans for expansion beyond infusion centers? - The commercial team is building upon its foundation to reach specialists caring for immunocompromised patients and plans to increase digital outreach and field presence [27][28] Question: How will Invivyd differentiate its early-stage discovery efforts in RSV and measles? - Management explained that differentiation will focus on resistance profiles and biophysical properties, with updates expected before the end of the year [29][30][32]