Drug maker Moderna, Inc. (MRNA), at its annual R&D Day event on Thursday, presented its outlook for fiscal 2025 and beyond, as well as various progress and strategic prioritization of its mRNA pipeline.
Moderna is also reducing its expected research and development investment for 2025-2028 by approximately 20% to $16 billion through prioritization from $20 billion for the period.
In pre-market activity on Nasdaq, Moderna shares were losing around 9.5 percent to trade at $71.99.
For fiscal 2025, the company expects revenue of $2.5 billion to $3.5 billion. For 2026-2028, the company expects a compounded annual growth rate of more than 25% or more, driven by new product launches.
Moderna plans to break even on an operating cash cost basis with $6 billion in revenue. The company expects to achieve this in 2028. The company said it has sufficient capital to fund its plans until achieving break even on a cash cost basis without raising additional equity.
Research and development expenses for fiscal 2025 are anticipated to be $4.2 billion to $4.5 billion, and for the 2026-2028 period, to be around $11.5 billion on a cumulative basis.
Capital expenditures for 2025 are expected to be approximately $0.3 billion. For 2026-2028, capital expenditures are expected to be flat to down from 2025 levels.
Moderna said its expects its commercial respiratory franchise to be profitable in 2024 and beyond. In addition, the Company is updating its projected 2024 research and development expenses to approximately $4.8 billion, primarily driven by the purchase of a Priority Review Voucher, and selling, general and administrative expenses to approximately $1.2 billion.
The company further said it is focusing on ten product approvals through 2027. Moderna now has five respiratory vaccines with positive Phase 3 results and expects to submit three for approval this year. In addition, five non-respiratory products are in pivotal studies across cancer, rare diseases and latent vaccines with potential for approval by 2027.
Moderna noted that it is implementing portfolio prioritization and cost efficiencies to reduce R&D expense by $1.1 billion, to $3.6 billion to $3.8 billion in 2027 from $4.8 billion in 2024E.
Stéphane Bancel, CEO of Moderna, said, "Our demonstrated probability of success in R&D has been higher than industry standards at every stage of development. The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these 10 products to patients, slow down the pace of new R&D investment, and build our commercial business."
Further, based on the company's strategic prioritization, five programs in its pipeline are discontinued. These include Endemic HCoV (mRNA-1287), RSV infants (mRNA-1345), KRAS antigen-specific therapy (mRNA-5671), Triplet (mRNA-2752), and Relaxin (mRNA-0184).
Moderna further said it aims to complete the majority of its respiratory investments by 2026.
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