Moderna is strategically restructuring its pipeline and reducing research and development spending to focus on key product approvals and achieve profitability amid evolving market conditions. The company aims to secure ten product approvals by 2027, emphasizing vaccines for respiratory viruses and expanding into oncology and rare diseases.
R&D Spending Cuts and Pipeline Prioritization
Moderna plans to decrease its research and development expenses by approximately 20%, targeting $16 billion for the period spanning 2025 to 2028. This reduction involves discontinuing five programs, including experimental vaccines for seasonal coronaviruses and RSV in infants, to concentrate resources on more promising candidates. According to Moderna's Chief Financial Officer Jamey Mock, this strategic shift aims to "really focus the portfolio" on critical approvals over the next few years, following "incredible clinical success" with multiple late-stage assets poised for regulatory submission.
Respiratory Vaccine Advancements
Moderna reported positive Phase 3 trial results for its next-generation COVID-19 vaccine (mRNA-1283) and its RSV vaccine (mRESVIA) in high-risk adults under 60. The company plans to submit these, along with a combination flu and COVID-19 vaccine, for regulatory approval this year. The next-generation COVID-19 vaccine, mRNA-1283, demonstrated non-inferior relative vaccine efficacy (rVE) compared to Spikevax, with a positive point estimate of 9.3% (99.4% CI: -6.6, 22.8). In the trial, mRESVIA met all primary immunogenicity endpoints and the 50 µg dose was well tolerated with no safety concerns identified.
Financial Outlook and Market Challenges
Moderna has adjusted its financial outlook, projecting sales between $2.5 billion and $3.5 billion for 2025, which is below analysts' forecasts. The company now expects to break even on an operating cash cost basis in 2028, two years later than its previous target. This delay reflects the uncertainty in the COVID-19 and RSV markets, as well as the time required for new product launches to generate significant revenue. Moderna's stock experienced a significant decline following the announcement, reflecting investor concerns about the company's near-term financial performance.
Strategic Focus on Key Products
Despite market challenges, Moderna is prioritizing the development and commercialization of several key products. These include a next-generation COVID-19 vaccine, a combination flu and COVID-19 vaccine, and an expanded indication for its RSV vaccine. The company is also advancing its norovirus vaccine into Phase 3 trials and continuing development of its personalized cancer vaccine in collaboration with Merck & Co. CEO Stéphane Bancel emphasized the need to focus on delivering these products to patients, stating, "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."
