Kaiyue Yang's questions to Invivyd (IVVD) leadership • Q1 2025
Question
Kaiyue Yang of Jefferies inquired about Invivyd's recent interactions with the FDA regarding the EUA pathway for COVID-19 prevention and treatment, the use of surrogate endpoints, and the specific headwinds that impacted Q1 sales, as well as the company's confidence in a Q2 rebound.
Answer
Marc Elia, Chairman, stated a preference to move beyond the EUA construct towards a BLA, leveraging their unique contemporary efficacy data and expressing confidence in SBNA titers as a validated surrogate endpoint. Timothy Lee, CCO, attributed the Q1 sales dip to the transition to an in-house sales force, a short-term disruption. He expressed confidence for Q2 based on strong early metrics, including record sales days and weeks, and a significant expansion of infusion sites to over 880.