Invivyd Q2 2024 Financial Results and Business Highlights

Invivyd, Inc., a biopharmaceutical company focused on combating serious viral infectious diseases, has reported its financial results for the quarter ending June 30, 2024, along with several significant business highlights.

In the second quarter, Invivyd launched PEMGARDA™, an investigational monoclonal antibody (mAb) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients, which generated $2.3 million in net product revenue. The company has seen a notable acceleration in commercial activities as the peak respiratory virus season approaches. Under the new leadership of Chief Commercial Officer Tim Lee, who has a strong track record in biopharmaceutical commercialization, Invivyd has successfully achieved Medicare and Medicaid coverage, rapid growth in commercial coverage, and increased utilization in infusion centers.

Lee expressed his enthusiasm for the company’s progress, highlighting the doubling of available infusion sites from the end of May to June, and again by the end of the following week. He emphasized the company's efforts to boost awareness of PEMGARDA among healthcare professionals and to expand its reach to more infusion centers. As the fall season approaches, the team is prepared to enhance their commercial efforts.

During the quarter, Invivyd also submitted an Emergency Use Authorization (EUA) amendment request to the U.S. FDA for the use of PEMGARDA in treating mild-to-moderate COVID-19 in certain immunocompromised patients. This request is based on immunobridging analyses and safety data from the CANOPY Phase 3 clinical trial.

Looking ahead, the company plans to commence dosing in a first-in-human clinical trial for VYD2311, a next-generation anti-RBD monoclonal antibody, by late August 2024. This molecule has demonstrated increased in vitro potency and could potentially lead to greater commercial quantities if regulatory authorization is achieved.

In terms of financial performance, Invivyd ended the second quarter with $147.9 million in cash and cash equivalents. The company anticipates ending the year with at least $75 million in cash, based on expected net product revenue of $150 million to $200 million for 2024. This forecast takes into account the authorization of PEMGARDA for PrEP of moderate to severe COVID-19 in specific immunocompromised populations.

In the realm of research and development, Invivyd reported R&D expenses of $30.3 million for the quarter, a decrease from $43.8 million in the same period of the previous year. This reduction is attributed primarily to a decrease in commercial manufacturing costs for PEMGARDA. Meanwhile, selling, general, and administrative expenses increased to $21.1 million, up from $10.1 million in the prior year, driven by higher personnel-related and commercial launch costs.

Notably, Invivyd's net loss for the quarter was $47.2 million, slightly lower than the $50.2 million loss reported in the same period of 2023. Basic and diluted net loss per share were $0.40, compared to $0.46 in the previous year.

In addition to these financial highlights, Invivyd announced that it had been added to the Russell 2000® and Russell 3000® Indexes, reflecting its growing market presence and investor interest.

Overall, Invivyd has made significant strides in the commercialization of PEMGARDA, with promising clinical developments on the horizon. The company remains focused on addressing the unmet needs of immunocompromised patients amid the ongoing COVID-19 pandemic and is well-positioned for continued growth and innovation in the biopharmaceutical sector.