Invivyd Reports $169.9 Million Net Loss for 2024, Highlights PEMGARDA Sales

Invivyd, Inc., a biopharmaceutical company focused on preventing and treating serious viral infectious diseases, reported a net loss of $169.9 million for the year ended December 31, 2024, compared to a net loss of $198.6 million in 2023. This improvement of $28.7 million was driven by $25.4 million in net product revenue generated from sales of PEMGARDA, their first monoclonal antibody (mAb) to receive emergency use authorization (EUA) from the FDA in March 2024. The company's cost of product revenue was $1.6 million for 2024, reflecting the costs associated with PEMGARDA sales. Research and development expenses decreased by $21.4 million to $137.3 million, primarily due to reduced spending on the pemivibart program and increased spending on VYD2311, their next-generation mAb candidate. Selling, general, and administrative expenses increased by $14.3 million to $63.4 million, largely due to increased headcount and commercialization efforts for PEMGARDA.

Significant changes compared to the previous year include the commencement of PEMGARDA sales, resulting in the $25.4 million in net product revenue. Research and development expenses decreased due to the completion of the pemivibart Phase 3 trial and the initiation of the VYD2311 Phase 1 trial. The company transitioned from using contract organizations for field-based sales roles to an in-house sales force during the fourth quarter of 2024 to support PEMGARDA commercialization. The company also completed recruitment for the Phase 1 clinical trial of VYD2311 in February 2025, reporting positive safety and pharmacokinetic data. Invivyd's financial statements reflect substantial doubt about their ability to continue as a going concern, based on their current operating plans and available cash resources.

Invivyd's strategic developments include the continued commercialization of PEMGARDA in the U.S., focusing initially on high-risk immunocompromised patients. The company is advancing VYD2311 through clinical trials, exploring intramuscular and subcutaneous administration routes. They are also actively engaging with the FDA to establish streamlined development pathways for future mAb candidates targeting SARS-CoV-2. Invivyd continues to monitor SARS-CoV-2 variants and reported continued neutralizing activity of PEMGARDA and VYD2311 against several dominant variants. The company relies heavily on partnerships with WuXi Biologics for manufacturing and Adimab for antibody discovery and engineering.

Key operational developments include the launch of PEMGARDA, resulting in $25.4 million in net product revenue in 2024. The company's sales force transitioned to an in-house model during 2024. As of February 1, 2025, Invivyd employed 99 full-time and one part-time employee. The company's manufacturing strategy relies on a single contract manufacturer, WuXi Biologics, for both clinical and commercial supply. Invivyd's distribution strategy utilizes third-party specialty distributors, with sales to the Title Company accounting for 19% of total gross sales in 2024.

Invivyd's outlook is contingent upon the continued success of PEMGARDA, the successful development and commercialization of VYD2311 and other product candidates, and their ability to secure additional funding. The company acknowledges substantial doubt regarding their ability to continue as a going concern without additional funding. They highlight the risks associated with the evolving SARS-CoV-2 virus, competition from other therapeutics, and the uncertainties of regulatory approvals and market acceptance. The company's future profitability is heavily dependent on the commercial success of PEMGARDA and the successful development and commercialization of future product candidates.