Moderna Reports on Progress and Strategic Priorities

Moderna used its annual R&D Day to announce program and financial updates demonstrating progress and strategic prioritization of its mRNA pipeline including data readouts in the company’s respiratory vaccine portfolio and a revised financial framework.

Over the past three years, Moderna’s robust pipeline has achieved milestones across multiple late-stage clinical trials, and its early-stage portfolio has produced proof-of-concept data with multiple candidates ready for pivotal studies. Moderna’s rate of success in research and development has been higher than the traditional biopharmaceutical industry. The company’s combined probability of success across its mid- and late-stage pipeline is approximately 66% compared to the industry average of approximately 19%.

Moderna’s broad clinical success and recent commercial challenges necessitate a more selective and paced approach to its research and development investment. Through portfolio prioritization and cost efficiencies, the company expects to reduce annual research and development expense by approximately $1.1 billion starting in 2027. During this time, Moderna will expand its commercial portfolio into oncology, rare diseases, and first-in-class non-respiratory vaccines. The company expects this strategy to yield 10 product approvals over the next three years.

Looking ahead to 2026-2028, Moderna will expand its commercial portfolio with first-in-class vaccines and therapeutics to address non-respiratory diseases, including cytomegalovirus, norovirus, propionic acidemia, methylmalonic acidemia, and melanoma. Based on the company’s strategic prioritization, five programs in its pipeline are being discontinued:

Moderna 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. Moderna is also reducing its expected research and development investment for 2025-2028 by approximately 20%, from $20 billion for the period to $16 billion through prioritization. The company aims to complete the majority of its respiratory investments by 2026. It is increasing research and development investments in oncology, and pacing its investments in latent and other vaccines and in rare disease therapeutics.

Moderna plans to break even on an operating cash cost basis with $6 billion in revenue in 2028 and has sufficient capital to fund its plans until achieving break even without raising additional equity. (Source: Moderna Website, 12 September, 2024).