Invivyd (IVVD) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Strategic focus and product development

• Focused on therapies for immunocompromised patients, with initial emphasis on COVID-19 prevention using Pemgarda, a monoclonal antibody.

• Achieved EUA for Pemgarda in March 2024, moving from first-in-human trials in under 12 months.

• Ongoing development of next-generation antibody VYD2311, currently in Phase 1 trials, aiming for improved potency and alternative administration routes.

• Platform technology enables rapid adaptation to emerging COVID-19 variants and potential expansion to other infectious diseases.

• Future pipeline may include targets like influenza and RSV, but current resources are focused on COVID-19.

Clinical data and efficacy

• Six-month data show Pemgarda reduces relative risk of COVID-19 infection by 84% with two doses; 12-month data show 64% risk reduction without additional dosing.

• Demonstrated strong activity against major circulating variants, including KP.3.1.1, with ongoing surveillance for new variants like XEC.

• Clinical efficacy data now included in the product fact sheet, improving prescriber confidence and supporting uptake.

• Internal and third-party data confirm continued effectiveness against current and emerging variants.

Commercial launch and market strategy

• Initial launch used an external sales force, now transitioning to internal resources for better control and expertise.

• Hired a Chief Commercial Officer to strengthen commercial and marketing efforts.

• Target population is about 500,000 high-risk immunocompromised patients in the U.S., serviced through approximately 1,200 healthcare centers.

• Over 400–450 sites currently offer Pemgarda, with ongoing efforts to expand penetration and awareness.

• Uptake was temporarily impacted by fact sheet amendments regarding variant resistance, but momentum has recovered following resolution.