Q3 2024 Summary
Published Jan 15, 2025, 2:40 AM UTC- Invivyd anticipates achieving profitability by the end of June 2025 by significantly reducing R&D expenses, as substantial manufacturing costs for PEMGARDA and VYD2311 have already been incurred and won't recur in the near term .
- PEMGARDA sales are experiencing positive growth trends, with increased investment in commercialization efforts, including expanding the sales team and enhancing patient access, positioning the company for continued revenue growth .
- Development of VYD2311, their next-generation antibody with improved potency and more patient-friendly administration routes (intramuscular and subcutaneous), offers potential for rapid regulatory approval and expansion into both prevention and treatment markets.
- Invivyd withdrew its 2024 net product revenue guidance of $150 million to $200 million, citing recent headwinds from the FDA's warning on potential reduced activity of pemivibart, raising concerns about future revenue growth and market uncertainty.
- The company experienced significant headwinds due to confusion among healthcare providers and patients following the FDA's updates on PEMGARDA's efficacy, which damaged sales opportunities and hindered utilization, casting doubt on their ability to drive revenue growth.
- Invivyd's plan to achieve profitability by the end of June 2025 relies on continued modest net product revenue growth and operational efficiency improvements, which may be challenging given recent setbacks and uncertain factors.
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Revenue Growth Expectations
Q: Is revenue growth significant or modest going forward?
A: Management expects continued growth and is pleased with recent trends, emphasizing that seasonality is not a major factor due to the constant need among vulnerable populations. They believe growth will be steady rather than significant stepwise increases. -
Path to Profitability and OpEx Reduction
Q: Will OpEx decline significantly to achieve profitability?
A: Management anticipates a reduction in R&D expenses, particularly as manufacturing campaigns wind down. They are focused on managing expenses without compromising the commercial presence, expecting the largest reductions to be on the R&D side. -
Guidance Reinstatement Confidence
Q: What gives confidence to provide guidance again?
A: The company feels good about meeting prospects if revenue continues to grow consistent with recent trends and effective expense management. They believe they've exited the period of confusion regarding product activity and can drive forward confidently. -
Treatment EUA for PEMGARDA
Q: Any updates on the treatment EUA feedback from FDA?
A: The company is updating the application as per FDA's bridging analysis requirements. They haven't heard explicit feedback but expect thoughts from the FDA on various topics soon. -
Inventory Value on Balance Sheet
Q: What is the commercial value of inventory on the balance sheet?
A: The company has produced inventory worth well over hundreds of millions of dollars in revenue terms. The accounting will reflect diminished spending in coming quarters, and discrepancies are due to expenses incurred prior to EUA granting. -
Next-Generation Antibody Development
Q: How do you engineer a more potent PEMGARDA?
A: They use a combinatorial library to select antibodies with enhanced properties, resulting in their next-generation molecule, VYD2311. This involves directed molecular honing against spike protein to enhance potency with modest structural changes. -
Regulatory Approval Path for VYD2311
Q: Is there an accelerated approval path for VYD2311?
A: Discussions are ongoing with the FDA. The company is gathering clinical data on safety and pharmacokinetics and believes prior data may support bridging to predicate antibodies, potentially allowing for rapid authorization for both treatment and prevention. -
Impact of Titer Thresholds on Approval
Q: Will high titer thresholds enable rapid approval?
A: They are assessing pharmacokinetic profiles to calculate titers and believe protection can be achieved at relatively low titers. The goal is to scale protection to as many people as possible rather than focusing solely on high titers.