Invivyd Announces Q1 2024 Financial Results and Business Highlights

Invivyd, Inc., a biopharmaceutical company based in Waltham, Massachusetts, recently announced its financial results for the quarter ending March 31, 2024, alongside several notable business achievements. The company, traded under the ticker IVVD on Nasdaq, focuses on providing protection against severe viral infectious diseases, with an emphasis on COVID-19.

Key among Invivyd’s recent milestones is the launch of PEMGARDA™ (pemivibart) in the United States. On March 22, 2024, PEMGARDA received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents with moderate-to-severe immune compromise. By early April, PEMGARDA had become available for purchase across the U.S. through authorized specialty distributors, and by the end of that month, Invivyd’s market access, sales, and medical affairs teams were fully operational nationwide. The company will begin reporting net product revenue from PEMGARDA starting with its second-quarter 2024 financial results.

In April 2024, Invivyd further secured product-specific reimbursement codes for PEMGARDA from the U.S. Centers for Medicare & Medicaid Services (CMS). The CMS granted a Healthcare Common Procedure Coding System (HCPCS) Q code (Q0224) for product reimbursement and an M code (M0224) for administration. This coverage is estimated to include nearly half of the moderately to severely immunocompromised individuals at high risk for severe COVID-19 that Invivyd targets.

Moreover, Invivyd shared interim exploratory COVID-19 clinical event data from the CANOPY Phase 3 clinical trial of VYD222 in March 2024. These interim results add to previous indications of potential clinical protection against symptomatic COVID-19.

In terms of pipeline developments, Invivyd has announced plans to pursue a rapid immunobridging pathway to potential EUA for COVID-19 treatment in certain immunocompromised individuals, based on feedback from the FDA. This strategy mirrors the approach used for obtaining EUA for PEMGARDA for COVID-19 PrEP. Additionally, Invivyd is advancing its next monoclonal antibody (mAb) candidate, VYD2311, which is optimized for neutralization potency against recent SARS-CoV-2 lineages like BA.2.86 and JN.1. This candidate leverages Invivyd’s advanced technologies for variant surveillance, predictive modeling, and antibody engineering.

Financially, Invivyd ended the first quarter of 2024 with cash and cash equivalents totaling $189.4 million. The company projects to end the year with at least $75 million in cash and cash equivalents, assuming anticipated 2024 net product revenue of $150-$200 million and recent resource realignment. Research and development (R&D) expenses for the quarter stood at $31.2 million, up from $28.0 million in the same period of 2023, primarily due to increased commercial manufacturing costs for PEMGARDA and clinical trial monitoring expenses. Selling, general, and administrative (SG&A) expenses rose to $14.9 million from $11.0 million in the previous year, driven by increased personnel and commercial preparation costs for PEMGARDA's launch. Net loss for the quarter was $43.5 million, compared to $35.3 million for the same period in 2023.

PEMGARDA (pemivibart) is a half-life extended investigational monoclonal antibody engineered from adintrevimab. It has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants and targets the virus's spike protein receptor binding domain (RBD), inhibiting virus attachment to host cells. The EUA for PEMGARDA allows its use for COVID-19 PrEP in immunocompromised adults and adolescents who are unlikely to respond adequately to COVID-19 vaccination.

Looking ahead, Invivyd remains focused on advancing its pipeline and commercializing PEMGARDA, while leveraging its proprietary INVYMAB™ platform for the rapid generation of new mAbs to address evolving viral threats. The company maintains its commitment to delivering innovative solutions for serious viral infectious diseases, beginning with SARS-CoV-2.