Q1 2024 Summary
Published Jan 15, 2025, 2:40 AM UTC- Imminent EUA submission for PEMGARDA as a treatment, expanding market potential: Invivyd is preparing to submit an Emergency Use Authorization (EUA) request for PEMGARDA for the treatment of mild to moderate symptomatic COVID-19 in immunocompromised individuals. The submission is expected within weeks rather than months, which could significantly expand the drug's market potential beyond prophylaxis.
- PEMGARDA offers advantages over existing treatments for immunocompromised patients: Existing treatments like PAXLOVID have drug-drug interactions, and remdesivir requires burdensome repeat intravenous infusions. PEMGARDA could fill an unmet need by providing a treatment option with fewer drug-drug interactions and more convenient administration, especially for immunocompromised patients with comorbidities.
- Positive engagement with FDA on rapid development pathways for next-generation antibodies like VYD2311: Invivyd is working closely with the FDA to establish novel, efficient development pathways for future monoclonal antibodies, which could accelerate the development and commercialization of next-generation products like VYD2311, potentially improving the company's competitive position.
- Uncertainty regarding reimbursement for half of the target patient population may limit the immediate addressable market and slow down PEMGARDA sales. The company is still working to secure commercial reimbursement with private payers, and this process may take time.
- Lack of transparency about current orders and sales figures suggests potential challenges in the commercialization of PEMGARDA. The company declined to provide details on orders or sales, stating it's too early to give information that would be informative for understanding how the year will play out.
- Absence of a clear direct-to-consumer marketing strategy for PEMGARDA could hinder product awareness and uptake among patients. The company is focusing on raising healthcare provider awareness and has not ruled out but is only exploring direct-to-consumer campaigns.
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PEMGARDA Treatment EUA Timeline
Q: When will you submit EUA for PEMGARDA's treatment indication?
A: The company stated that the EUA submission is imminent, meaning within weeks rather than months or quarters. They are leveraging prior clinical experiences to support both PrEP and treatment use cases. While they did not change guidance or provide quantification, they are quite excited about the potential size of this opportunity. -
Reimbursement Coverage Expansion
Q: How will you address reimbursement for the other half of patients?
A: The company is working to obtain commercial reimbursement for the other half of the moderate to severe immunocompromised population not covered by existing codes. Their national account management team is actively engaging with payors, and they are encouraged by the initial engagement. They acknowledge that the process takes time as payors review their formularies, with more updates to come as the launch progresses. -
Development Plans for VYD2311
Q: What's the development framework for VYD2311?
A: The company is collaborating with the FDA to innovate pathways and establish bespoke and proprietary pathways enabled by their unique molecules and discovery engine. They are evolving these plans in real time and will provide specifics as they become available. -
Order Magnitude and Sales Timing
Q: What is the magnitude of orders, and when will sales be booked?
A: The company has made preliminary disclosures in prior press releases but is not providing incremental detail at this time. It's early in the launch phase, and they anticipate providing more feedback and information as they look forward to the summer and fall. -
Marketing Strategy for PEMGARDA
Q: Are you exploring direct-to-consumer campaigns for PEMGARDA?
A: Initially, the focus is on raising healthcare provider awareness, as it's critical providers are informed when patients seek access to the product. They have not ruled out direct-to-consumer marketing in the future and are exploring targeted patient campaigns. They observe that immunocompromised patients are active in managing their health, with organic interest online, and sometimes patients are ahead of healthcare providers in awareness.