Financial Performance - For Q3 2025, the company reported net product sales of $973 million, a decrease of 46% compared to $1.8 billion in Q3 2024[115] - The net loss per share for Q3 2025 was $(0.51), contrasting with a net income per share of $0.03 in Q3 2024[115] - Total revenue for Q3 2025 decreased by $846 million, or 45%, to $1,016 million compared to Q3 2024[130] - Net product sales for Q3 2025 were $973 million, down $847 million, or 47%, from $1,820 million in Q3 2024[130] - Net loss for Q3 2025 was $200 million, compared to a net income of $13 million in Q3 2024, representing a decline of $213 million[130] - Interest income for Q3 2025 decreased by $30 million, or 29%, totaling $73 million compared to $103 million in Q3 2024[141] - The company expects a decline in net product sales for the full year 2025 due to lower expected vaccination rates and increased market competition[131] - The company incurred a net loss of $2.0 billion for the nine months ended September 30, 2025, following net losses of $3.6 billion and $4.7 billion for the years 2024 and 2023, respectively[156] Research and Development - The company has a pipeline of 30 development candidates across 40 programs, with 37 currently in clinical studies[110] - The Phase 3 trial for the investigational CMV vaccine (mRNA-1647) did not meet its primary efficacy endpoint, leading to the discontinuation of the congenital CMV clinical development program[119] - The company anticipates significant future capital requirements for ongoing research and development activities, including new vaccine candidates and digital capabilities[157] Product Approvals and Developments - The company has received approval for the 2025-2026 formula of Spikevax in 40 countries and for mNEXSPIKE in the U.S. for adults aged 65 and older[111] - mRESVIA has been approved for adults aged 60 and older in 40 countries, and for individuals aged 18 to 59 at increased risk in 31 of those countries[112] - The 2025-2026 formula of Spikevax generated over an 8-fold increase in LP.8.1-neutralizing antibodies in at-risk individuals aged 12-64 and all adults 65 and older[119] - The 2025-2026 formula of mNEXSPIKE generated over a 16-fold increase in LP.8.1-neutralizing antibodies in the same age groups[119] - The company plans to complete submissions for approval of its seasonal flu vaccine (mRNA-1010) by January 2026[119] Operational Metrics - Cash, cash equivalents, and investments decreased by $2.9 billion, or 30%, to $6.6 billion as of September 30, 2025, primarily due to a net cash outflow from operating activities of $2.8 billion[144] - Working capital decreased by $1.0 billion, or 17%, to $4.9 billion as of September 30, 2025, primarily due to a decrease in cash and current investments[145] - Net cash used in operating activities was $2.8 billion for the nine months ended September 30, 2025, consisting of a net loss of $2.0 billion and non-cash adjustments of $519 million[150] - Net cash provided by investing activities was $2.0 billion for the nine months ended September 30, 2025, driven by proceeds from maturities and sales of marketable securities of $6.4 billion[153] - Net cash provided by financing activities decreased by $47 million, or 80%, to $12 million for the nine months ended September 30, 2025, primarily due to a decrease in proceeds from issuance of common stock[155] Deferred Revenue - As of September 30, 2025, the company had deferred revenue of $144 million related to product sales, with $79 million expected to be realized in less than one year[128] - As of September 30, 2025, the company had $144 million in deferred revenue related to product sales[149] Cost Management - Research and development expenses for Q3 2025 decreased by $336 million, or 30%, totaling $801 million compared to $1,137 million in Q3 2024[135] - Selling, general and administrative expenses for Q3 2025 decreased by $13 million, or 5%, totaling $268 million compared to $281 million in Q3 2024[138] - Cost of sales for Q3 2025 was $207 million, a decrease of $307 million, or 60%, compared to $514 million in Q3 2024[133] - Total other income (expense), net improved to $4 million for the nine months ended September 30, 2025, compared to a total expense of $58 million in 2024, driven by lower equity investment losses and reduced interest expense[142] Manufacturing Capabilities - The mRNA manufacturing facilities in Australia and the UK became operational in Q3 2025, supporting domestic mRNA manufacturing and pandemic preparedness[113] - The company launched commercial sales of its RSV vaccine, mRESVIA, in Q3 2024 and expects limited contribution to total product sales in 2025[131]
Moderna(MRNA) - 2025 Q3 - Quarterly Report