Adagio(US:IVVD)2025-09-03 19:10Summary of Invivyd (IVVD) Conference Call - September 03, 2025 Company Overview - Company: Invivyd (IVVD) - Product: PEMGARDA, a monoclonal antibody authorized under Emergency Use Authorization for the prevention of COVID-19 in certain immunocompromised individuals [2][4] Core Points and Arguments 1. Current Status: Invivyd is a commercial-stage company with an authorized product, PEMGARDA, and is developing a next-generation monoclonal antibody, VYD2311, aimed at improving efficacy and safety compared to existing vaccines [2][3][4] 2. Technological Advantage: The company emphasizes its unique technology that allows for the evolution of antibodies to enhance their biophysical properties, which is expected to lead to better medical outcomes for patients [3][4] 3. Regulatory Engagement: Invivyd has had constructive dialogues with the FDA regarding the development of VYD2311, which is positioned as a potential alternative to vaccines for COVID-19 [4][5][22] 4. Market Positioning: The company aims to shift the reliance from vaccines to monoclonal antibodies for COVID-19 prevention, targeting both high-risk adults and pediatric populations [5][14] 5. Clinical Efficacy: PEMGARDA has shown an 85% to 94% reduction in the likelihood of getting sick, although it is described as a specialty medicine with logistical challenges for administration [8][10] 6. Future Development: The company plans to conduct clinical trials for VYD2311, which is expected to have a favorable product profile compared to vaccines, including higher efficacy, safety, and durability [24][25][39] 7. Commercial Strategy: Invivyd is focused on education and engagement with key opinion leaders and decision-makers to prepare for the commercialization of VYD2311 [40][41] 8. Cost Structure: The expected cost of goods sold (COGS) for VYD2311 is projected to be below $100, with a retail price potentially around several hundred dollars, aiming to provide a broad population medicine rather than a specialty product [44][45][46] Important but Overlooked Content 1. Regulatory History: The regulatory journey of PEMGARDA has been complex, with the FDA and EMA initially defining its role narrowly, which has impacted its market penetration [7][10] 2. Public Perception: The company acknowledges the challenges posed by public perception and misinformation regarding COVID-19 treatments and vaccines, emphasizing the need for clear communication of the benefits of monoclonal antibodies [28][30] 3. Potential for Resistance: Invivyd is aware of the potential for emerging resistance to antibodies but believes that their current product, VYD2311, will maintain efficacy due to its stable epitope [47][48] This summary encapsulates the key points discussed during the conference call, highlighting Invivyd's strategic direction, product development, and market positioning in the context of COVID-19 treatment.