Invivyd’s Earnings Call: Positive Outlook Amid Challenges

Invivyd ((IVVD)) has held its Q3 earnings call. Read on for the main highlights of the call.

Invivyd’s recent earnings call was marked by a generally positive sentiment, driven by significant developments such as receiving FDA feedback for their antibody VYD2311, a successful capital raise, and notable revenue growth. However, the company acknowledged challenges related to the lack of modern data on COVID vaccines and logistical coordination with FDA centers.

FDA Feedback and Capital Raise

Invivyd received crucial feedback from the U.S. FDA regarding the development of their vaccine alternative antibody, VYD2311. This guidance is pivotal as the company moves forward with its clinical studies. Additionally, Invivyd successfully raised approximately $87 million in capital, which will be instrumental in funding these studies and expanding their commercial organization.

Revenue Growth

The company reported an impressive revenue increase of 11% quarter-on-quarter and 41% year-over-year. This growth reflects Invivyd’s strategic efforts in driving market awareness and expanding its reach within the healthcare sector.

Expansion in GPO Sites

Invivyd has significantly expanded its presence, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion services. Notably, 76% of accounts have reordered, indicating strong customer retention and satisfaction.

Broad Commercial Opportunity

The company sees a substantial commercial opportunity in providing a widely available option for COVID prevention, especially given last year’s U.S. COVID vaccine sales of $3.8 billion. Invivyd aims to capture a significant share of this market by offering an alternative to existing vaccines.

Lack of Modern Data on COVID Vaccines

One of the challenges highlighted was the scarcity of controlled data on the efficacy of COVID vaccines beyond the original studies. This gap in data affects Invivyd’s ability to position VYD2311 effectively in the market.

Coordination Challenges with FDA Centers

Invivyd is facing logistical challenges in coordinating between CBER and CDER for the LIBERTY study. This type of study is relatively uncommon, adding complexity to the process.

Forward-Looking Guidance

Invivyd provided forward-looking guidance, emphasizing its successful capital raise to support pivotal clinical programs and commercial expansion. The company plans to initiate its pivotal program for VYD2311 by year-end, with top-line data expected by mid-2026. Invivyd aims to address COVID-19 prevention through the LIBERTY study, comparing VYD2311 to mRNA vaccines, with a focus on safety and tolerability. The company expressed confidence in its financial position and innovative approach to potentially offering a superior option to existing vaccines.

In summary, Invivyd’s earnings call conveyed a positive outlook with significant achievements in FDA feedback, capital raising, and revenue growth. Despite challenges with data and coordination, the company remains optimistic about its strategic initiatives and market opportunities, particularly in COVID-19 prevention.