During the J.P. Morgan Healthcare Conference, Moderna (NASDAQ:MRNA) disclosed key financial updates and progress reports on its pipeline. Here’s a summary of the highlights:
Financial Updates for 2023
Moderna reported unaudited/preliminary product sales amounting to nearly $6.7 billion for 2023. This revenue was entirely attributed to the sales of its mRNA-based COVID-19 vaccine, aligning with the company’s previously communicated guidance of at least $6 billion in full-year vaccine sales. The reported figure exceeded Wall Street analysts’ projections and surpassed model estimates, resulting in a 3.9% surge in Moderna’s stock on Monday.
The unaudited $6.7 billion includes $6.1 billion from COVID-19 vaccine sales and an additional $600 million in deferred revenues related to Moderna’s collaboration with GAVI, the global vaccine alliance. Despite a 39.1% loss in stock value over the past year, Moderna’s U.S. market share for COVID-19 vaccines increased to 48% in 2023, up from 37% in 2022.
The company anticipates closing the year with a cash balance and investments exceeding $13 billion, with detailed financial results for Q4 and full-year 2023 to be unveiled during the earnings call on Feb 22.
Outlook for 2024 and Beyond
Moderna reaffirmed its previously issued financial guidance for 2024, expecting profitability for its COVID-19 franchise from that year onward. With a focus on disciplined investments and the launch of multiple products, including the RSV vaccine, the company aims to achieve organic sales growth by 2025 and break even in 2026. The projected product revenues for 2024, primarily from COVID-19 vaccine sales and the RSV vaccine launch, are estimated at $4 billion.
Pipeline Updates
Modern’s late-stage pipeline boasts nine phase III programs targeting various indications, such as cytomegalovirus, respiratory syncytial virus (RSV), influenza, and individualized neoantigen therapy (INT). The mRNA-1345 RSV vaccine for older adults is expected to secure regulatory approval in the first half of 2024, with a commercial launch later in the year.
Encouraging data from a late-stage study on the flu vaccine mRNA-1010 was reported in Q3 2023, meeting all immunogenicity endpoints. Moderna plans to file for regulatory approval later this year. Additionally, the company intends to release pivotal data from studies on mRNA-1283, the next-generation refrigerator-stable COVID-19 vaccine, and mRNA-1083, an investigational combination vaccine against influenza and COVID-19, in the first half of 2024.
The INT therapy mRNA-4157, developed in collaboration with Merck (MRK), achieved primary and key secondary endpoints in a phase IIb study in the first half of 2023. Two pivotal phase III studies initiated in the second half of 2023 are evaluating the vaccine in melanoma and non-small cell lung cancer (NSCLC) indications. Moderna and Merck plan to expand mRNA-4157 into additional tumor types later this year. The company also anticipates advancing its propionic acidemia (PA) and methylmalonic acidemia (MMA) programs into pivotal studies in 2024.
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