• Net Product Revenue: $9.3 million in Q3 2024.
• Cash and Cash Equivalents: Approximately $107 million as of September end.
• Projected Year-End Cash: Expected to finish 2024 with $65 million or more.
• Relative Risk Reduction: 84% during active treatment and 76% over 12 months in the CANOPY study.
• Profitability Target: Expected to turn profitable by the end of June 2025.

• Warning! GuruFocus has detected 3 Warning Signs with IVVD.

Release Date: November 14, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Invivyd Inc (NASDAQ:IVVD) has demonstrated strong efficacy of its monoclonal antibody, pemivibart, in reducing the risk of symptomatic COVID-19 by 80% to 90% in clinical trials.
• The company has a robust pipeline with the development of VYD2311, which shows improved potency and potential for more patient-friendly administration routes.
• Invivyd Inc (NASDAQ:IVVD) has a significant inventory of PEMGARDA, which positions them well for future sales without immediate manufacturing expenses.
• The company is actively expanding its commercial efforts, including partnerships with infusion centers and developing a digital presence to better serve the immunocompromised community.
• Invivyd Inc (NASDAQ:IVVD) is targeting near-term profitability with existing cash reserves and operational efficiency improvements, aiming to be profitable by mid-2025.

Negative Points

• Invivyd Inc (NASDAQ:IVVD) faced significant commercial headwinds due to doubts about the efficacy of pemivibart against certain COVID-19 variants, impacting their market performance.
• The company had to withdraw its revenue guidance due to these headwinds and the resulting confusion among healthcare providers and patients.
• There is uncertainty regarding the regulatory pathway for their next-generation antibody, VYD2311, which could affect future product launches.
• The company's R&D expenses have been high, partly due to manufacturing costs, which have impacted their financial performance.
• Invivyd Inc (NASDAQ:IVVD) is still in the early stages of market penetration, and there is uncertainty about the impact of seasonality on their sales growth.

Q & A Highlights

Q: Could you provide any additional color on the treatment EUA for PEMGARDA, and what would give you confidence in providing guidance again? A: Marc Elia, Independent Chairman of the Board, explained that they are updating the EUA application and have not received explicit feedback from the FDA yet. Confidence in guidance would depend on consistent revenue growth and expense management. Tim Lee, Chief Commercial Officer, added that recent trends and growth activities are promising.

Q: On revenue, are we talking about significant stepwise increases month-over-month or modest growth? How does that change in the first quarter and the second quarter? A: Marc Elia noted that while COVID-19 is not seasonal, the company is early in its growth, so seasonality effects are not yet a concern. Tim Lee emphasized that their focus is on serving immunocompromised individuals, whose needs are not seasonal, and they are working to increase access and utilization.

Q: What is the commercial value of the inventory on the balance sheet? A: Marc Elia stated that Invivyd has produced inventory worth hundreds of millions in revenue terms. William Duke, CFO, added that the discrepancy between market value and balance sheet value is due to expensed costs prior to EUA.

Q: How do you engineer a more potent or next-generation formula of PEMGARDA? A: Marc Elia explained that they use a combinatorial library to enhance antibody potency against spike protein. Robert Allen, Chief Scientific Officer, added that they constantly update their knowledge to maintain antibody activity against current and future variants.

Q: Regarding VYD2311, would there be a need for separate trials for treatment or prevention? A: Marc Elia mentioned that the treatment EUA application drew upon the same clinical data as the PrEP authorization. They are assessing safety and pharmacokinetics and will discuss data with the FDA to determine the path forward.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.