Invivyd Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides Recent Business Highlights

Core Insights - Invivyd, Inc. reported a significant revenue growth of 48% for its product PEMGARDA™ in Q4 2024, reaching $13.8 million compared to$9.3 million in Q3 2024, contributing to a full-year revenue of $25.4 million [2][4][12] - The company aims for near-term profitability by the end of the first half of 2025, leveraging existing cash reserves of$69.3 million and anticipated revenue growth [4][12] - Invivyd is advancing its next-generation monoclonal antibody, VYD2311, which has shown promising Phase 1 clinical data, indicating a 17-fold greater neutralization potency against contemporary SARS-CoV-2 variants compared to PEMGARDA [4][12][16] Financial Performance - For the year ended December 31, 2024, Invivyd reported a net loss of $169.9 million, an improvement from a net loss of$198.6 million in 2023, with a net loss per share of $1.43 compared to$1.81 in the previous year [12][28] - Research and development expenses decreased to $137.3 million in 2024 from$163.6 million in 2023, primarily due to lower personnel and manufacturing costs [12][28] - Selling, general, and administrative expenses increased to $63.4 million in 2024 from$49.1 million in 2023, attributed to higher personnel costs and commercialization efforts for PEMGARDA [12][28] Product Development and Regulatory Updates - PEMGARDA has demonstrated consistent neutralizing activity against major circulating SARS-CoV-2 variants, reinforcing its potential as a pre-exposure prophylaxis for vulnerable populations [4][5][12] - The FDA declined Invivyd's request to expand the emergency use authorization of PEMGARDA for treating mild-to-moderate COVID-19 in immunocompromised patients, prompting the company to seek reconsideration [5][12] - VYD2311 is positioned as a novel monoclonal antibody candidate with a potentially improved administration route, aiming to address the ongoing need for effective COVID-19 treatments [16][17] Strategic Initiatives - The company has initiated a collaboration with professional football coach Jim Harbaugh to enhance awareness of COVID-19's impact on vulnerable populations [5][12] - Invivyd's in-house sales force has been transitioned to support the commercialization of PEMGARDA, targeting healthcare providers who treat at-risk patient populations [2][12]