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Moderna Scales Back RSV Ambitions, Cuts Pipeline Programs Amid Market Challenges

• Moderna acknowledges slower-than-expected uptake of its RSV vaccine mResvia, facing stiff competition from established players GSK and Pfizer in the U.S. market.

• The company announces significant restructuring, including $1.1 billion reduction in annual R&D spending by 2027 and discontinuation of five pipeline programs including cancer treatments and RSV infant vaccine.

• Despite setbacks, Moderna outlines strategic shift focusing on oncology development while maintaining respiratory disease programs, targeting five new product launches by 2027.

Moderna is recalibrating its market expectations for its recently approved respiratory syncytial virus (RSV) vaccine, mResvia, amid challenging competition from pharmaceutical giants GSK and Pfizer. The biotechnology company's leadership acknowledged underestimating the complexities of market entry during their R&D Day conference.
"Maybe we were overly optimistic about our ability to compete in the first year of RSV," admitted Moderna CFO Jamey Mock. CEO Stéphane Bancel echoed this sentiment, taking responsibility for what he described as a "naive or too optimistic" launch strategy.

Market Dynamics and Competitive Landscape

The company's RSV vaccine, which received FDA approval in late May, has struggled to gain traction in a market dominated by GSK's Arexvy. Moderna cited contracting challenges and delays in securing CDC usage recommendations as key factors affecting their market penetration.

Strategic Restructuring and Pipeline Optimization

In response to these challenges, Moderna announced significant organizational changes:
  • Annual R&D spending reduction of $1.1 billion by 2027
  • Discontinuation of five pipeline programs, including:
    • Two cancer treatments
    • A heart failure therapy
    • Endemic human coronavirus vaccine candidate
    • RSV vaccine for infants
"As we've gone through and done our semiannual prioritization process, these [programs] didn't meet the bar for carrying forward," explained Stephen Hoge, Moderna's president.

Financial Outlook and Future Focus

The company has revised its financial projections, now forecasting:
  • 2025 sales between $2.5 and $3 billion
  • Break-even timeline extended by two years
Moderna's strategic pivot includes increased focus on oncology while maintaining key respiratory disease initiatives. The company's pipeline priorities include:
  • Next-generation COVID-19 vaccine development
  • Combination influenza and COVID vaccine advancement
  • Standalone flu vaccine entering confirmatory efficacy studies
  • Melanoma vaccine development in partnership with Merck & Co.
  • Late-stage cytomegalovirus vaccine testing
  • Potential Phase 3 trial initiation for norovirus candidate

Market Response and Analyst Perspectives

The company's recent challenges have not gone unnoticed by market analysts. William Blair analyst Myles Minter noted that "lofty financial expectations followed by guidance walk-backs" have resulted in a more than 40% decline in share value since early August.
Leerink Partners analyst Mani Foroohar suggests that more substantial changes may be necessary, indicating that current restructuring efforts might not be sufficient to restore investor confidence in the company's long-term sustainability.
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Reference News

[1]
Moderna, trailing rivals, checks its RSV shot expectations | BioPharma Dive
biopharmadive.com · Sep 13, 2024

Moderna acknowledges slower-than-expected uptake of its RSV vaccine, mResvia, amid competition from GSK and Pfizer. The ...

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