Invivyd, Inc. Q3 FY2025 earnings call

Marc Elia:

• Q3 2025 marked a turning point; received FDA feedback on VYD2311 for broad COVID populations. Raised ~$87M in capital. Upcoming pivotal program for VYD2311 to initiate end-2025 with top-line data mid-2026. Discussed design of declaration and LIBERTY studies for VYD2311.

Tim Lee:

• PEMGARDA progress: over 15,000 contracted GPO sites, over 1,200 infusion sites with 76% reordering, presence at over 125 conferences. IDSA and NCCN guidelines recommend PEMGARDA. Sees a large commercial opportunity for VYD2311 if approved.

Bill Duke:

• Q3 revenues up 11% QoQ and 41% YoY. Improved cash position from public offering and ATM facility, well capitalized for VYD2311 pivotal data and commercial expansion.

No detailed financial breakdown by product segments with revenue contribution percentages provided in the transcript.

• Pivotal program for VYD2311 to initiate around year-end 2025 and deliver top-line data in mid-2026.
• Well funded to execute pivotal clinical program and expand commercial organization for VYD2311 launch while maintaining operating discipline.

• Forward-looking statements subject to various risks, assumptions, and uncertainties that may cause actual results to differ materially from those expressed. Risk factors affecting business can be found in SEC filings including Form 10-K and 10-Q.

Q: Do you plan on winding down PEMGARDA once the next-gen product is approved? And if so, over how much time?

A: Alex, thanks for the question. I think the easiest answer right now is simply no. PEMGARDA is a differentiated medicine at the molecular level and there are no plans to actively sunset.

Q: Can you please clarify the coordination between CBER and CDER that is required for the LIBERTY study?

A: Well, I can certainly tell you what we know, but I think that sort of insight is best left as a question to the FDA. By virtue of a law dating back to 2002, there are different responsibilities between CBER and CDER. Therapeutic monoclonal antibodies have traditionally been handled by CDER. When comingling prophylactic medicines in a study, there would be dialogue between these centers on the nature and boundary sets of our study. It's a logistical step involving unusual coordination at their end but no particular extraordinary risk.

Q: Could you please discuss the commercial team's current reach and any plans to expand beyond infusion centers as you transition towards intramuscular delivery for VYD2311?

A: Yes, great question. We've built a scalable foundation around an infused specialty medication. We're building upon that to meet specialists caring for immunocompromised patients and those who will be the target audience for VYD2311 if approved. We'll see more around digital assets and community reach, and an increase in field presence in the next year.

Q: You mentioned early-stage discovery efforts in RSV and LIBERTY. How do you intend to differentiate those programs? And what's the realistic timeline for development candidate nomination?

A: Great. These are discovery programs. Differentiation for nasals antibody is easy currently as there aren't any. We approach viruses by looking at variation, druggable targets, and using our platform to create high-potency, broad coverage medicines. In RSV, differentiation can be through resistance profile, biophysical properties, etc. We plan to provide an update on both programs before the end of the year. After polishing something and being happy with it, they could be rapidly advanced into clinical space with different development campaigns and use cases.