Moderna has tempered expectations for its near-term financial performance, delaying its projected break-even point by two years and forecasting lower-than-expected sales for 2025. This announcement, made at an investor conference in New York, led to a significant drop in the company's stock price, with shares plummeting 17.1% to $65.88.
Financial Revisions and Sales Forecasts
Moderna now anticipates achieving operational cash cost break-even in 2028, a shift from its previous target. The company projects sales between $2.5 billion and $3.5 billion for 2025, which is below both analysts' forecasts of $3.74 billion and Moderna's own projection of $3 billion to $3.5 billion for 2024. Chief Financial Officer James Mock attributed this forecast to uncertainties in the COVID and respiratory syncytial virus (RSV) markets in the U.S., as well as the anticipated revenue generation timeline for new products.
Product Development Timelines
Stephen Hoge, Moderna's President, cited the commercial challenges of launching multiple products within a short timeframe as a factor in the revised outlook. The regulatory process for key products, including flu and cancer vaccines, is taking longer than initially projected. Notably, Moderna has dropped its request for fast-track approval for its standalone influenza vaccine, opting instead to focus on a combination shot for COVID and influenza.
RSV Vaccine Expansion and Cancer Vaccine Update
Moderna plans to submit an FDA application this year to broaden the approval of its mRESVIA shot for RSV to include high-risk adults under the age of 60, following positive data from a late-stage trial. The vaccine is currently approved for adults aged 60 and older. In contrast, initial feedback from the FDA did not support accelerated approval for Moderna's cancer vaccine, which is being developed in collaboration with Merck.
Competitive Landscape
Moderna's mRESVIA competes with RSV vaccines from GSK (Arexvy) and Pfizer (Abrysvo). While Moderna reported that mRESVIA met all immune-response targets and was well-tolerated in adults aged 18 and older with compromised immune systems, it faces a competitive market with established players and varying recommendations from health authorities regarding RSV vaccination for different age groups.
