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Dec 31, 2023
Invivyd Q4 2023 Earnings Report
Invivyd reported financial results for the full year ended December 31, 2023, and announced the emergency use authorization (EUA) of PEMGARDA for PrEP of COVID-19.
Key Takeaways
Invivyd announced financial results for the full year ended December 31, 2023, highlighted by the emergency use authorization of PEMGARDA for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents. The company's cash and cash equivalents totaled $200.6 million as of December 31, 2023. They expect to provide insights on key launch metrics as time progresses.
Received emergency use authorization for PEMGARDA™ for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents.
PEMGARDA product availability in the U.S. is anticipated imminently.
PEMGARDA is the first authorized mAb from Invivyd’s INVYMAB™ platform approach.
Leveraged INVYMAB platform approach to design VYD2311, the company’s next anticipated SARS-CoV-2 candidate.
Invivyd
Invivyd
Forward Guidance
Invivyd anticipates its existing total cash and cash equivalents will enable the company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024, excluding anticipated cash collections from PEMGARDA sales.
Positive Outlook
- PEMGARDA product availability in the U.S. anticipated imminently
- VYD2311 will be the next mAb candidate to enter clinical development
- Engaging with the FDA with the aim of establishing a streamlined development pathway
- Rapidly and perpetually deliver antibody-based therapies
- Believe that we can efficiently reach key healthcare practitioners and institutions who care for the highest risk moderately to severely immunocompromised adults and adolescents
Challenges Ahead
- How long the EUA granted by the FDA for PEMGARDA will remain in effect and whether the EUA is revoked or revised by the FDA
- The company’s ability to build and maintain sales, marketing and distribution capabilities to successfully commercialize PEMGARDA
- Unexpected safety or efficacy data observed during preclinical studies or clinical trials
- Whether the company is able to provide sufficient commercial supply of PEMGARDA to meet market demand
- The company’s ability to continue as a going concern