Moderna, Inc.

“We are a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA).”

“Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules;”

“We currently have three commercial products—Spikevax® and mNEXSPIKE®, our COVID vaccines, and mRESVIA®, our vaccine against respiratory syncytial virus (RSV).”

“a diverse development pipeline of 25 development candidates across our 35 development programs currently in clinical studies”

“We have received approval in 40 countries for our 2025-2026 formula for Spikevax.”

“Our mRNA-1010 regulatory filings are under review in the United States, Europe, Canada and Australia.”

“Our RSV vaccine has been approved for adults aged 60 years and older in 40 countries.”

“Our intismeran autogene product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production;”

“We have two main campuses in Massachusetts, our Moderna Science Center (MSC), located in Cambridge, which serves as our headquarters, and our Moderna Technology Center (MTC), located in Norwood.”

“We are dependent on single-source suppliers for some of the components and materials used in, and the manufacturing processes required to develop and commercialize, our products and product candidates;”

“the expansion of our U.S. manufacturing capabilities through the onshoring of drug product manufacturing to our existing Moderna Technology Center in Norwood, Massachusetts.”

“against Pfizer and Sanofi for sales of our COVID vaccines and Pfizer and GSK for our RSV vaccine.”

“We compete with larger, well-established and experienced pharmaceutical companies for sales of our products, including against Pfizer and Sanofi for sales of our COVID vaccines and Pfizer and GSK for our RSV vaccine.”

“we experienced a decline in customer demand for our COVID vaccine in 2023 and 2024, and this trend has continued into 2025 as the market transitions to a more competitive and commercially driven environment.”

“our ability to deliver cost efficiency across our business and to achieve targeted cash breakeven;”

“our ability to drive sales growth through geographic expansion and new product launches; our expectations regarding revenue growth in 2026;”

“For the years ended December 31, 2025, 2024, and 2023, inventory write-downs were $291 million, $495 million, and $2.2 billion, respectively.”

“Total contractual cash obligations$3,451 $635 $750 $1,213 $853”

“In November 2025, we entered into a Credit Agreement providing for a term loan facility with aggregate commitments of $1.5 billion. As of December 31, 2025, we had drawn $600 million under the initial term loan.”

“We foresee that our commitment to investing in our business for future product launches may lead to continued negative cash flows from operations in upcoming periods.”

“For the year ended December 31, 2025, we recognized total revenue of $1.9 billion compared to $3.2 billion and $6.8 billion for the years ended December 31, 2024 and 2023, respectively.”

“We believe that our cash, cash equivalents, and investments as of December 31, 2025, together with cash expected to be generated from product sales and available borrowings under our credit facility, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months”

“We are also subject to extensive federal, state and foreign anti-bribery regulations, including the U.S. Foreign Corrupt Practices Act (FCPA), the UK Bribery Act and similar laws in other countries.”

“one or more government entities could take actions (such as via the Defense Production Act in the U.S.) that diminish our rights or economic opportunities with respect to our products.”

“In 2025, changes at U.S. regulatory agencies impacted policies and priorities related to our industry.”

“we have been excluded from selling our COVID vaccines in many European markets due to a competitor's contract with the European Commission, which does not lapse until year-end 2026.”

“These charges in 2025 and 2024 were primarily driven by the continued operation of the COVID vaccine market as a seasonal market, along with a decline in overall customer demand and excess inventory.”

“We have experienced, and may experience additional, cyber-attacks on our information technology systems and infrastructure by threat actors of all types”

“Beyond COVID, we have experienced challenges in the RSV market, in part due to advisory committee recommendations that were more limited than anticipated.”

“We are exposed to physical risks (such as rising temperatures, flooding and severe storms), risks in transitioning to a low-carbon economy (such as additional legal or regulatory requirements, changes in customer behavior and cost and availability of raw materials)”

“We have entered into strategic alliances with third parties for product development and commercialization. If these alliances are unsuccessful, our business could be adversely affected;”

“The turnover rate in our industry is high and we compete with other companies, as well as academic institutions, for individuals with certain skill sets.”

“Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes, which is inherently costly and unpredictable and can have adverse financial and freedom-to-operate consequences;”

“Third parties could illegally distribute and sell, especially online, counterfeit versions of mRNA products that do not meet the rigorous cGMP manufacturing and testing standards.”