Moderna, Inc. (NASDAQ:MRNA) has unveiled significant progress and strategic updates in its mRNA pipeline during its annual R&D Day event. The company emphasized its focus on achieving ten product approvals by 2027, highlighting advancements in its respiratory vaccine portfolio and outlining a revised financial framework.

Key Highlights

• Next-Generation COVID Vaccine: Moderna expects to submit its next-generation COVID-19 vaccine for approval in 2024.
• Flu/COVID Combination Vaccine: Anticipated submission for approval in 2024, aiming to provide broader protection.
• Positive Phase 3 RSV Vaccine Results: Successful trials for high-risk adults aged 18 to 59, with plans to submit a supplemental Biologics License Application (sBLA) in 2024.
• Standalone Flu Vaccine Success: Positive Phase 3 results for adults aged 65 and older compared to a high-dose licensed comparator.
• Norovirus Vaccine Progress: Advancement into Phase 3 studies, expanding the non-respiratory pivotal programs to five, covering oncology, rare diseases, and first-in-class vaccines.
• Cost Reduction Initiatives: Implementation of portfolio prioritization and cost efficiencies to reduce R&D expenses by $1.1 billion, lowering projected spending from $4.8 billion in 2024 to $3.6-3.8 billion by 2027.
• Extended Financial Framework: Updates to the financial outlook extended through 2028.

Strategic Focus on Product Delivery and Commercialization

“Moderna now has five respiratory vaccines with positive Phase 3 results and expects to submit three for approval this year,” stated Stéphane Bancel, CEO of Moderna. He emphasized the necessity to concentrate on delivering these products to patients, moderating the pace of new R&D investments, and expanding the company’s commercial operations.

Research and Development Success Rates

Over the past three years, Moderna’s pipeline has reached significant milestones across multiple late-stage clinical trials. The company’s combined probability of success in mid- and late-stage pipelines is approximately 66%, markedly higher than the industry average of around 19%^[1]. This success necessitates a more selective approach to R&D investment to ensure the effective launch of upcoming products.

Financial Strategy and Cost Efficiency

Moderna plans to implement portfolio prioritization and cost-saving measures, aiming to reduce annual R&D expenses by approximately $1.1 billion starting in 2027. This adjustment will lower the expected R&D spending from $4.8 billion in 2024 to an estimated $3.6-3.8 billion by 2027. The financial strategy supports the expansion into oncology, rare diseases, and first-in-class non-respiratory vaccines.

Pipeline Expansion and Approvals

The company is poised to expand its commercial portfolio significantly, with expectations to achieve 10 product approvals over the next three years. Key areas of focus include:

• Oncology: Advancing mRNA-based cancer therapeutics.
• Rare Diseases: Developing treatments for conditions with high unmet medical needs.
• First-in-Class Vaccines: Introducing innovative vaccines targeting latent viruses and other non-respiratory pathogens.

Advancements in Vaccine Development

Moderna’s recent accomplishments in vaccine development are noteworthy:

• Respiratory Syncytial Virus (RSV) Vaccine: Positive Phase 3 results in high-risk adults aged 18 to 59, with plans for regulatory submission in 2024.
• Influenza Vaccine: Successful Phase 3 trial results in adults 65 and older, demonstrating efficacy relative to existing high-dose vaccines.
• Norovirus Vaccine: Progression to Phase 3 studies, marking significant advancement in addressing gastrointestinal infections.

Outlook and Future Developments

With a robust pipeline and strategic focus, Moderna aims to maintain its leadership in mRNA technology. The company’s emphasis on commercial execution and selective R&D investment positions it to deliver innovative healthcare solutions globally.

Reference

^[1] Industry average probability of success data sourced from relevant pharmaceutical industry benchmarks.

About Moderna, Inc.

Moderna, Inc. is a biotechnology company specializing in messenger RNA (mRNA) therapeutics and vaccines. The company’s platform is based on pioneering mRNA science and the development of a new class of transformative medicines for patients.