Invivyd's Q1 2025 Earnings Call: Unpacking Contradictions in EUA Strategy, Sales Execution, and Market Approach

Regulatory strategy and path for PEMGARDA EUA, sales and commercial strategy, EUA status and future EAU applications, sales strategy and seasonality, marketing strategy and sales approach are the key contradictions discussed in Invivyd's latest 2025Q1 earnings call.



Commercial Transition and Sales Growth:
- Invivyd transitioned its commercial operations to an internal team, which led to a temporary decrease in sales as the new team was established and trained.
- The company reported $11.3 million in PEMGARDA net product revenue for Q1 2025, with early signs of recovery and acceleration in Q2.
- This transition was aimed at driving broader adoption of PEMGARDA and improving commercial results.

Regulatory and R&D Pipelines:
- Invivyd is expanding its R&D pipeline to multiple disease areas, including RSV and measles, in addition to its ongoing COVID-19 focus.
- The company initiated new discovery programs for an RSV monoclonal antibody and a monoclonal antibody for measles prevention and treatment.
- This strategic shift is aimed at leveraging their scientific approach to develop best-in-class medicines for high-value opportunities.

Financial Discipline and Cost Management:
- Invivyd reported a 15% reduction in operating expenses from Q4 2024 to Q1 2025, with a total $27.4 million in Q1 2025.
- The company anticipates continued reductions in operating expenses due to manufactured supply and controlled manufacturing expenses.
- This discipline is part of their strategy to target profitability by the end of the first half of 2025.

Regulatory Engagement and EUA Expansion:
- Invivyd is engaging with the FDA to explore moving beyond EUAs and towards BLAs for its products, leveraging their unique clinical efficacy data.
- The company is actively pursuing the use of surrogate endpoints like sVNA titers for regulatory approvals.
- This approach is aimed at aligning with the evolving regulatory landscape and normalizing approval processes similar to accelerated approvals for vaccines.