Adagio(US:IVVD)2025-11-06 14:32Financial Data and Key Metrics Changes - Invivyd's PEMGARDA revenues grew by 11% quarter-on-quarter and 41% year-over-year, reflecting ongoing market awareness efforts [19] - The company raised approximately $87 million in capital during the quarter, enhancing its financial position for upcoming clinical programs [5][19] Business Line Data and Key Metrics Changes - The commercial franchise for PEMGARDA is expanding, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion services, with 76% of those accounts reordering [14][15] - The company is transitioning from a smaller patient population to a broader market with the potential approval of VYD2311, aiming to replace current vaccine options [14][18] Market Data and Key Metrics Changes - COVID vaccine sales in the U.S. totaled $3.8 billion last year, indicating a significant market opportunity for Invivyd's products [18] - Current COVID vaccine uptake is substantially below that of influenza vaccines, despite higher public concern about COVID [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][18] - The company plans to initiate pivotal clinical studies for VYD2311 around year-end 2025, with top-line data expected in mid-2026 [7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming 12-18 months, highlighting the potential for significant advancements in COVID prevention for vulnerable populations [7] - The company aims to address safety concerns associated with COVID vaccines through its antibody-based approach, which is expected to have a favorable side effect profile [12][13] Other Important Information - The DECLARATION and LIBERTY studies are designed to provide critical data on the efficacy and safety of VYD2311 compared to existing vaccines [10][13] - Invivyd is also exploring early-stage discovery efforts in RSV and measles, with plans for rapid advancement into clinical development [31][33] 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 [22] Question: Can you clarify the coordination between CBER and CDER for the LIBERTY study? - Management indicated that coordination between CBER and CDER is expected due to the unique nature of the study, but specific details are best addressed by the FDA [24][26] Question: What are the commercial team's current reach and plans for expansion? - The commercial team is building upon its foundation in infusion centers and plans to expand its reach through digital assets and increased field presence [30] Question: How does Invivyd intend to differentiate its early-stage discovery programs in RSV and measles? - Management highlighted the focus on viral resistance and biophysical properties as key differentiation factors for the new antibody programs [32][33]