Invivyd, Inc. Q1 FY2024 earnings call

• Marc Elia highlighted the transformational last few months for Invivyd, focusing on addressing SARS-CoV-2 challenges with engineered antibodies and the company's strategy to combine monoclonal antibodies with product evolution.
• Bill Duke discussed ending Q1 2024 with $189.4 million in cash and cash equivalents, updated cash guidance improvement, and the commitment to filing a second EUA for PEMGARDA.
• Jeremy Gowler provided an update on the PEMGARDA launch, noting positive interest, logistics phase, reimbursement efforts, and potential additional EUA for treatment of mild-to-moderate symptomatic COVID-19 in immunocompromised people.
• Mark Wingertzahn discussed the Canopy Phase III clinical trial, EUA submission for treatment, and plans for a compact clinical trial to generate confirmatory safety, pharmacokinetic, and clinical virology data.
• Robert Allen talked about VivydTools, virus variation tracking, and discovery technologies for antibody optimization to anticipate virus evolution and improve product profiles.

No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

• Ended Q1 2024 with $189.4 million in cash and cash equivalents. Updated cash guidance improved by ~$20-$25 million, built to include anticipated spend on 2024 incremental clinical commitments. Will not alter year-end cash and top line revenue guidance even if EUA treatment is achieved. Look forward to updating estimates in the fall.

Forward-looking statements are subject to various risks, assumptions, and uncertainties that may change over time and cause actual results to differ materially from those expressed or implied. Additional information on risk factors can be found in Invivyd's filings with the U.S. Securities and Exchange Commission, including the most recent Form 10-K.

Q: Congratulations on the progress. Can you elaborate on marketing strategy, including direct-to-consumer campaigns and physician specialty for PEMGARDA, and how the compact clinical trial will leverage data and if it's in response to FDA feedback?

A: Marc Elia mentioned the compact trial is rooted in intellectual alignment with prior clinical work, and Mark Wingertzahn added it's for evaluating treatment emergent resistance, safety, and PK data. Jeremy Gowler discussed early focus on raising HCP awareness.

Q: Regarding reimbursement for the other half of the target population and approval pathway for PEMGARDA's treatment EUA?

A: Marc Elia stated submission of EUA is imminent, drawing from common material and clinical experience. Jeremy Gowler talked about national account management team working on commercial reimbursement.

Q: On pipeline development for VYD2311 and treatment opportunity?

A: Marc Elia and Mark Wingertzahn discussed development is evolving with FDA collaboration, leveraging unique molecules and discovery engine. Mark Wingertzahn highlighted potential use case in immunocompromised patients with drug-drug interaction issues.

Q: On magnitude of orders, shipments, and booking sales?

A: Marc Elia noted it's early in the launch, and they'll provide more detail as the launch progresses, but not providing incremental detail today.