Second quarter 2023 revenues of $0.3 billion; net loss of $1.4 billion and loss per share of $3.62

Company expecting 2023 COVID-19 vaccine sales of $6 billion to $8 billion, dependent on U.S. vaccination rates

Company submitted its investigational RSV vaccine to several regulators globally ahead of potential 2024 launch

With its partner Merck, the Company began Phase 3 trial of mRNA-4157, its individualized neoantigen therapy (INT), in combination with Keytruda®, for high-risk melanoma

CAMBRIDGE, MA / ACCESSWIRE / August 3, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the second quarter of 2023.

"Second quarter sales were on target, given the seasonal nature of Covid. I am pleased with the progress our U.S. commercial team has made to get new contracts in place for fall 2023. We are on track to deliver 2023 sales between $6 billion to $8 billion, depending on Covid vaccination rates in the U.S.," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our late-stage clinical pipeline is firing on all cylinders with four infectious disease vaccines in Phase 3, including RSV which was recently submitted to regulators for approval. Our individualized neoantigen therapy is now in Phase 3 for melanoma and our lead rare disease program for PA is in dose confirmation. We believe that all these products should launch in 2024, 2025 or 2026, and we are continuing to invest in scaling Moderna to bring forward an unprecedented number of innovative mRNA medicines for patients."

Recent progress includes:

Respiratory Vaccines

COVID-19

The Company presented clinical data at the June VRBPAC meeting demonstrating potent neutralization and cross-reactivity with its monovalent XBB.1.5 vaccine, mRNA-1273.815. Similar neutralization was seen for XBB.1.5, XBB.1.16, and XBB.2.3.2 sub-variants. Following the FDA's recommendation for a monovalent SARS-CoV-2 XBB lineage vaccine, which aligns with other regulators and global public health agencies, Moderna has submitted its updated COVID-19 vaccine to regulators globally for approval or authorization and is ready for fall vaccination season with ample and timely supply.

RSV

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 regulatory applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as either two or more symptoms or three or more symptoms of disease. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p