Moderna Inc.

"mCOMBRIAX received marketing authorization from the European Commission in April 2026 for the prevention of influenza disease and COVID-19 in individuals 50 years of age and older"

"The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of mRNA-1010 outweigh its risks for the prevention of influenza disease"

"Our Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis"

"The settlement resolves all worldwide Arbutus/Genevant litigation related to Spikevax and mRESVIA and provides certainty going forward for our full infectious disease portfolio, including mNEXSPIKE, mCOMBRIAX and our future vaccine pipeline, with no future royalties owed."

"Consistent with the terms of the settlement agreement, we have appealed the District Court's decision related to 28 U.S.C. § 1498 to the Federal Circuit Court of Appeals and could be required to make an additional payment of up to $1.3 billion depending on the outcome."

"Product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities."

"In August 2025, the FDA revoked the EUA for emergency use of our COVID vaccine."

"We have experienced commercial challenges and may experience additional challenges in the future. We face risks and uncertainties related to successfully commercializing our products."

"We also compete against other vaccines, including Sanofi and Novavax's. Additionally, some competitors have developed COVID treatments, including Pfizer's antiviral pill, which may reduce demand for vaccines. With respect to our RSV vaccine, we compete against Pfizer and GlaxoSmithKline, who entered the U.S. market prior to us, and our RSV sales have been minimal to date."

"In October 2025, we announced topline results from the Phase 3 pivotal trial evaluating the efficacy of mRNA-1647, our investigational CMV vaccine. The study did not meet its primary efficacy endpoint of preventing CMV infection in seronegative female participants of childbearing age (16 to 40 years of age)."

"For the third quarter of 2025, we recognized net product sales of $973 million, compared to $1.8 billion for the third quarter of 2024."

"In May 2025, we received notice from HHS that the award for late-stage development and the right to purchase pre-pandemic influenza vaccines would be terminated. Revenue recognized related to this agreement was immaterial as of September 30, 2025."

"We anticipate seasonal fluctuations in demand for our COVID and RSV vaccines, with higher sales expected during the fall and winter seasons."

"In May 2025, we received notice from the U.S. Department of Health and Human Services that our award for the late-stage development of mRNA-based pandemic influenza vaccines would be terminated."

"mNEXSPIKE, our newest commercial product, was approved by the U.S. Food and Drug Administration in May 2025 for individuals aged 65 years and older, as well as individuals aged 12 through 64 years with at least one underlying risk factor."

"As COVID has transitioned to a seasonal respiratory vaccine, we anticipate a decline in net product sales for the full year 2025 compared to 2024, primarily due to lower expected vaccination rates and increased competition."

"We anticipate a reduction in research and development expenses in 2025 compared to 2024, driven by disciplined cost management and a focused approach to pipeline execution."

"Cost of sales as a percentage of net product sales for the three months ended March 31, 2025 increased to 104%, compared to 58% for the same period in 2024, reflecting the impact of lower net product sales."

"In 2024, we recognized $3.1 billion of product sales, compared to $6.7 billion, $18.4 billion and $17.7 billion in 2023, 2022 and 2021, respectively."

"We faced commercial challenges that led to lower-than-expected sales and required us to adapt our business strategy. We experienced difficulties maintaining our COVID vaccine market share and gaining market share in the U.S. for our RSV vaccine, where we were third to market."

"The commercial markets for these vaccines are seasonal and characterized, particularly in the U.S. (our largest market), by a fragmented customer base, unpredictability in orders and seasonality of deliveries."

"In May 2024, the U.S. Food and Drug Administration (FDA) granted approval for mRESVIA (mRNA-1345), our mRNA vaccine against respiratory syncytial virus (RSV), to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection. This marks our second approved mRNA product."

"For the third quarter of 2024, we recognized net product sales of $1.8 billion from sales of our COVID-19 and RSV vaccines, compared to $1.8 billion for the third quarter of 2023. Earnings per share was $0.03 for the third quarter of 2024."

"As of September 30, 2024, we had deferred revenue of $443 million associated with customer deposits received or billable under supply agreements, with the majority of our COVID-19 vaccine deliveries scheduled in 2024."

"In May 2024, the U.S. Food and Drug Administration (FDA) granted approval for mRESVIA® (mRNA-1345), our mRNA vaccine against respiratory syncytial virus (RSV), to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection. This marks our second approved mRNA product."

"We anticipate that the demand for our COVID-19 vaccine will be higher in the fall and winter seasons across both hemispheres, as countries prepare for seasonal vaccination campaigns. For the full year of 2024, we expect the progression toward a seasonal commercial market to persist, resulting in further projected reductions in net product sales for our COVID-19 vaccine relative to 2023."

"In June 2024, we announced that our next-generation COVID-19 vaccine candidate (mRNA-1283) met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax in participants 12 years of age and older."

"For the full year of 2024, we expect the progression toward a seasonal commercial market to persist, resulting in further projected reductions in net product sales for our COVID-19 vaccine relative to 2023."

"In March 2024, we entered into a development and commercialization funding agreement with Blackstone Life Sciences to advance our flu program...The funding will be recognized as a reduction to the expenses of our flu program. We will retain full rights and control of our flu program."

"We have a diverse and extensive development pipeline of 40 development candidates across our 47 development programs, of which 43 are in clinical studies currently."

"In the third quarter of 2023, we completed our long-range financial planning process, incorporating revised forecasts of vaccination rates. This resulted in the reassessment of future demand for our COVID-19 vaccine, leading to a strategic initiative to resize our manufacturing cost structure."

"Inventory write-downs were mainly related to obsolete inventory due to shelf-life expiration and inventory in excess of expected demand. Losses on firm purchase commitments were primarily related to excess raw material purchase commitments that will expire before the anticipated consumption of those raw materials."

"We reassessed the evidence and concluded that a valuation allowance was necessary due to the preponderance of negative evidence, including a year-to-date pre-tax loss and a projected pre-tax loss for the full year 2023, serving as a significant source of objectively verifiable negative evidence."