Invivyd, Inc. Q3 FY2024 earnings call

Key Points

• Third quarter had a promising start but faced a commercial headwind rooted in academic virology complex and U.S. FDA impact on reaching HCPs in vulnerable populations.
• PEMGARDA showed robust protection in CANOPY Phase 3 clinical trial, with 80%-90% reduction in symptomatic COVID-19 risk in immunocompetent population over six months and long-term follow-up data showing protection even at low residual drug levels after six months.
• VYD2311 is in first-in-human study, with aim to improve biophysical properties and explore intravenous, intramuscular, and subcutaneous dosing.
• Third quarter began commercial transformation: partnering with infusion centers, developing digital presence, bringing in sales team, investing in patient support programs, field reimbursement management, and federal account team.
• PEMGARDA's safety profile remained consistent, and there was a return to product growth.

The key product is PEMGARDA. In Q3 2024, PEMGARDA net product revenue was 9.3 million. Revenue contribution is from the commercialization of PEMGARDA, which is Invivyd's monoclonal antibody against SARS-CoV-2.

Guidance

• Expect to finish 2024 with 65 million or more in cash and cash equivalents.
• Target near-term profitability with existing cash, anticipated net product revenue growth, and operational efficiency improvements.
• Guidance is based on continuation of trend rather than seasonal bolus of revenue, feeling good about ability to drive growth from current position.

Risks

• Virus variation, such as the doubt on PEMGARDA's activity against KP.3.1.1 observed at Columbia University over summer and fall, which led to FDA broadcasting doubt and damaging Invivyd's opportunity to drive utilization.
• Applied virology is an inexact science, with many labs globally using processes and systems of unknown quality and reagents of unknown characteristics, posing risks to understanding Invivyd's molecules.

Q: Can you provide any additional color on the treatment EUA for PEMGARDA if you received any feedback from the FDA? And also, the reason I understand for pulling guidance, but what would give you confidence in providing guidance again? Should we expect it at the end of the year, early next year?

A: On treatment EUA, been updating timely as a bridging analysis, not heard explicit feedback yet but FDA is aware of perspectives. Confidence in guidance is based on continuation of trend in revenue growth and ability to manage expenses. Feel good about exiting majority of confusion and ability to drive forward.

Q: Can you help us understand while you expect steady growth or growth based on the metrics you're disclosing, are we talking about significant stepwise increases month over month, or are we talking about modest growth? And to that extent, how does that change in the first quarter and the second quarter? And then on the OpEx, of course, the natural question is that has to change as well in order to hit profitability. So is that expected to be significant declines in R&D over the next few quarters?

A: Have begun modifying base burn, not compromising on commercial presence. R&D flexes with clinical activities, coming off CANOPY spend, not yet at registrational spend for VYD2311. Manufacturing spend for PEMGARDA has substantially completed, leading to reduction in R&D spend.

Q: What is the real commercial value of that inventory on the balance sheet? It's obviously substantially higher than what you're carrying at.

A: Invivyd has produced well in excess of hundreds of millions of dollars of product inventory in revenue terms. Costs incurred leading up to EUA granting remain on balance sheet as inventory amounts not yet sold through.

Q: Would there be a need for separate trials for treatment or prevention, or based on the PEMGARDA fast track, would there be a possibility that a new way could be approved for both treatment and prevention? I'm just thinking about if there's an accelerated path for 2311?

A: Stay tuned, topics of active consideration. PEMGARDA's treatment EUA application drew on same clinical data as PrEP authorization. VYD2311 is in first-in-human study, and will dialogue with FDA on safety and authorization paths, with confidence in generalizability of protection concepts.