Invivyd, Inc. Q1 FY2025 earnings call

• Commercial organization is fully internalized, with focus on driving broader adoption of PEMGARDA. Leading indicators are promising, targeting near-term breakeven with revenue growth and expense management. • Scientifically, pleased with the evolutionary journey of SARS-CoV-2 relative to pemivibart's epitope. Secured non-dilutive capital to grow if conditions met. Expanding pipeline to multiple disease areas, added discovery programs against new viral targets, including RSV monoclonal antibody and measles discovery program. • Commercial progress: Transitioned to in-house commercial footprint, re-educating healthcare providers on monoclonal antibodies, overcoming skepticism about PEMGARDA navigating virus evolution, PEMGARDA now in NCCN Guidelines for B-cell lymphomas, Q2 revenues showing growth with bigger commercial days and weeks. • R&D updates: Confident in long-term pemivibart activity due to epitope stability, progress in RSV discovery program, and ongoing measles discovery program.

PEMGARDA was the key focus. Q1 revenues dipped from Q4, but Q2 has shown strong revenues including biggest ever commercial day and week. No other distinct product segments with detailed financial performance and revenue contribution % provided.

• Targeting near-term breakeven with continued revenue growth and operating expense management. • Plan to expand pipeline to multiple disease areas and capitalize on potential strategic partners. • Aim to be profitable by the end of the first half of 2025. • Interest from potential partners, particularly those with a vaccine footprint, is noted.

• Regulatory uncertainties related to EUA expansion, bridging to BLA, and FDA's perspective on efficacy assurance. • Market adoption challenges, including healthcare provider skepticism and the need to educate on PEMGARDA's value. • Biotech investing backdrop with tougher equity cost of capital, requiring disciplined expenditure and capital base management.

Q: Could you please characterize your recent interaction and/or experience with the new agency, particularly on EUA, including maintaining your EUA for COVID prevention and use of EUA for future applications, including for treatment and also use of surrogate endpoints such as virus titers for approval? The second one real quick is on Q1 sales, could you please characterize your -- the headwinds that you encountered in Q1? I understand your team briefly discussed it. Could you please expand on that and tell us how you addressed these areas of improvements in the second quarter and just help us think about your sales in Q2 and how do you and your confidence, what gives you confidence that you’re going to see the momentum continue in the second quarter?

A: Marc Elia started by discussing EUA, stating preference to move beyond EUA construct and leverage contemporary efficacy data for BLA. Tim Lee expanded on Q1 headwinds, mentioning disruption from decoupling from contract sales organization but seeing positive momentum with in-house team, growth in sites with PEMGARDA, and strong Q2 revenues with increasing breadth and depth of accounts.

Q: Can you discuss a little bit more in detail the measles program, if you plan to pivot to measles? And if you -- whatever details you can share on the expected clinical trial development path and potential market size? And how -- and in the context of your current cash position and the non-diluted loan facility, how you’re planning to prioritize?

A: Marc Elia and Mark discussed that adding measles discovery program is about adding optionality, not pivoting. It's part of standing budgets, focusing on early discovery with no significant incremental draw from cash balances, and prioritizing based on potential value creation for patients and shareholders.