Q2 2024 Summary
Published Jan 15, 2025, 2:40 AM UTC- Invivyd expects significant sales growth in the upcoming months, particularly in September, October, and November, due to increased demand during the fall/winter respiratory virus season, and is geared up to capitalize on this period.
- The company is seeing acceleration in commercial results in early Q3, partly due to the summer COVID-19 wave, indicating increasing demand for their product PEMGARDA among the immunocompromised population.
- Invivyd is rapidly expanding its infusion site network, including major academic and private infusion centers, increasing the availability and accessibility of PEMGARDA to patients in need.
- Supply constraints of PEMGARDA may limit sales, as the company faces limitations and plans to transition to VYD2311. The executive stated, "we face supply constraints on PEMGARDA" and intend to "transition rapidly to VYD2311".
- Uncertainty around regulatory approvals for the second EUA could delay market opportunities, impacting revenue. The executive mentioned, "it's certainly not within our purview to opine on the timing of anything that [the FDA] might choose to do or not do".
- Previous inadequate commercialization efforts require significant changes, potentially delaying revenue growth. The Chief Commercial Officer noted that "the prior commercial leadership team... was that of a vaccine commercialization rather than biopharmaceutical and critically infused biologic therapies".
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Second EUA Timing and Opportunity
Q: Will second EUA be approved by year-end?
A: Management believes receiving the second EUA by year-end is reasonable but can't specify the FDA's timing. They see the treatment opportunity as potentially additive but aren't assigning specific numbers yet. -
Sales Expectations for Second Half
Q: How will second-half sales be weighted?
A: Sales are expected to be heavily weighted towards September–November, aligning with the peak immunization season. Early Q3 shows acceleration, but the main impact is anticipated as people return indoors. No significant stocking is expected; inventory will be managed via just-in-time shipping. -
EU Filing and OUS Status
Q: Any updates on filing in OUS?
A: The company is exploring options but may focus OUS efforts on future products like 2311 due to supply constraints for PEMGARDA. Global regulators are not harmonized, and there's nothing immediate on the horizon. -
Visibility on Q3 Ordering
Q: What's your visibility on ordering in Q3?
A: The company has seen acceleration in early Q3 results but expects significant impact to begin in a few weeks as the fall season starts. They are preparing for increased demand as people focus on prevention. -
Infusion Site Availability and Expansion
Q: Does the infusion site locator reflect availability, and efforts to expand?
A: The infusion locator is being updated and will soon reflect more sites. They are prioritizing major academic centers and partnering with private infusion sites to increase access. -
Plans for Fall Immunization Season
Q: What's needed to optimize success this fall?
A: New leadership is focusing on digital work, corporate campaigns, and updating the infusion locator. They are engaging with over 200 infusion sites and the patient community to act with urgency.