• Third quarter 2023 revenues of $1.8 billion; Company expects 2023 revenues of at least $6 billion
• Spikevax U.S. market share to date increased to 45% from 36% in 2022
• Company anticipates 2024 revenue of approximately $4 billion and return to growth in 2025
• Company has significantly improved future cost of sales by resizing its manufacturing capacity, contributing to a third quarter net loss of $3.6 billion, primarily driven by mostly non-cash charges of $3.1 billion related to resizing and a tax valuation allowance
• Company's late-stage pipeline has six Phase 3 programs
• Company expects to break even in 2026 through product launches and disciplined investment

CAMBRIDGE, MA / ACCESSWIRE / November 2, 2023 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the third quarter of 2023.

"Through this quarter, we demonstrated our ability to increase share in the U.S. market, and we now expect this year's vaccination rate to be similar to last fall," said Stéphane Bancel, Chief Executive Officer of Moderna. "In the third quarter, we significantly resized our manufacturing infrastructure to make our COVID-19 franchise profitable for 2024 and beyond. We are preparing to launch multiple products through 2025, including our RSV vaccine. We expect to return to sales growth in 2025 and, through disciplined investment, to break even in 2026."

Recent progress includes:

2023 Commercial Updates

COVID-19: The Company reported $1.8 billion in Spikevax® (COVID-19 vaccine) sales in the third quarter of 2023, which includes $0.9 billion of U.S. sales and $0.8 billion of international sales. This leads to $3.9 billion in vaccine sales for the year through the third quarter. The Company believes that the U.S. market for fall 2023 will be at least 50 million doses, supporting total 2023 Spikevax sales of at least $6 billion. The U.S. fall 2023 vaccinations administered in retail pharmacies to date are tracking similarly to the 2022 fall season, despite a later launch. Spikevax is available in all leading pharmacies and points of care and continues to gain market share. With 45% cumulative market share1 as of the most recently available date in October, Moderna's market share in the fall 2023 season is tracking ahead of its cumulative market share of 36% during the fall 2022 U.S. vaccination season.

The Company continues to focus on public health efforts to increase vaccination rates globally. In the United States, the Company has undertaken significant marketing and awareness campaigns, working closely with vaccinators and others to drive a robust vaccination season, including by activating the medical community, supporting and re-engaging customers (including those who deferred updated vaccination due to recent infections) and amplifying the voices of credible influencers.

RSV: The Company continues to expect the launch of its RSV vaccine in 2024 with a potential best-in-class profile. Moderna has submitted marketing authorization applications globally for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older. The Company filed for a Biologics License Application (BLA) with the FDA and used a Priority Review Voucher (PRV) to accelerate review.

The regulatory applications are based on positive data from the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults, 60 years or older. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p