Total Revenue

Declined ~35% (from $167M in Q1 2024 to $108M in Q1 2025)

The revenue drop reflects a continuing decline in COVID-related sales as the market shifts to a seasonal commercial model, with fewer vaccinations compared to the pandemic high levels. This decline in demand is compounded by increased market competition and reduced product volumes, as previously seen in the transition from FY2023 to FY2024. " "

Net Product Sales

Declined ~48% (from $167M in Q1 2024 to $86M in Q1 2025)

Product sales contracted dramatically due to diminishing COVID vaccine uptake, as the company normalizes from its pandemic peak. The 48% drop is attributed to lower vaccination rates and reduced reliance on previously strong product lines. " " "

U.S. Revenue

Declined ~71% (from $100M in Q1 2024 to $29M in Q1 2025)

U.S. sales suffered a steep decline as the demand for COVID vaccines plummeted with the phaseout of advance purchase agreements and a drop in vaccination rates. The significant reduction in U.S. revenue continues the trend observed in earlier periods where market shifts heavily impacted domestic sales. " "

Rest of World Revenue

Modest decline (from $67M in Q1 2024 to $55M in Q1 2025)

International revenue experienced a less pronounced drop compared to the U.S., reflecting a slightly more resilient market abroad. The modest decline signals that while the seasonal market transition affects all regions, the Rest of World markets are less volatile than the U.S. market. " "

Operating Performance (Net Loss & Basic EPS)

Net Loss narrowed from $1,175M to $971M; Basic EPS improved from –$3.07 to –$2.52

Improvement in operating performance is driven by cost efficiencies and expense reductions amid declining sales. Despite lower revenues, the company managed to narrow its net loss and improve EPS by reducing operating expenses, reflecting an ongoing strategy to optimize the cost structure even as revenue trends are negative. " "

Cash, Cash Equivalents & Restricted Cash

Q1 2025 balance at $1,626M (decline from previous period)

Effective cash management maintained liquidity despite falling sales. The balance of $1,626M in Q1 2025 reflects prior efforts to optimize cash flows and manage working capital, ensuring sufficient liquidity in a period of declining revenue. "

Total Revenue

FY 2025

Expected to be in the range of $1.5 billion to $2.5 billion; first‐half sales of approximately $0.2 billion "

Expected to be in the range of $1.5 billion to $2.5 billion; first half sales are anticipated to be approximately $0.2 billion "

no change

Cost of Sales

FY 2025

Approximately $1.2 billion "

Approximately $1.2 billion "

no change

R&D Expenses

FY 2025

Approximately $4.1 billion "

Approximately $4.1 billion "

no change

SG&A Expenses

FY 2025

Approximately $1.1 billion "

Approximately $1.1 billion "

no change

Taxes

FY 2025

Expected to be negligible "

Expected to be negligible "

no change

Capital Expenditures

FY 2025

Approximately $0.4 billion "

Approximately $400 million "

no change

Cash and Investments

FY 2025

Expected to be approximately $6 billion "

Expected to be approximately $6 billion "

no change

Cost Reductions

FY 2027

no prior guidance

Additional cost reductions of $1.4 billion to $1.7 billion "

no prior guidance

2026 GAAP Operating Expense Forecast

2026

no prior guidance

Reduced from $5.9 billion to a range of $5.4 billion to $5.7 billion; excluding noncash charges, cash cost is projected at ~$4.7 billion "

no prior guidance

2027 GAAP Expenses

2027

no prior guidance

Planned to be reduced to between $4.7 billion and $5 billion; with a cash cost of approximately ~$4.2 billion "

no prior guidance

Expanding and Diversified Pipeline

Mentioned consistently from Q2 through Q4 2024 with detailed updates on oncology (e.g., mRNA‐4157), CMV, RSV, norovirus, and checkpoint programs; discussions included early-phase data and Phase III trial enrollments. " " " "

Q1 2025 call reiterated a broad pipeline spanning oncology, norovirus, CMV, and RSV while noting continued expansion into additional cancer indications and deprioritization of some programs (e.g. younger adult combination vaccines). " " "

The focus remains diversified and steady; however, there is a re‐prioritization with resources shifting away from some areas (e.g. younger adult combination vaccines, mRNA pulmonary therapies) toward oncology and high‐value vaccine programs, reflecting a strategic evolution without loss of breadth.

COVID‑19 Vaccine Performance and U.S. Market Share

Q2 2024 reported nearly 50% U.S. market share with robust sales, Q3 2024 noted a 40% retail share with competitive pressures, and Q4 2024 highlighted a decline in vaccination rates and lower volume due to increased competition. " " " " "

In Q1 2025, although U.S. revenue decreased (e.g. $29 million in Q1 2025), Moderna maintained a market share around 38–40% with customers managing lower inventories, reflecting a subdued yet stable competitive position. "

Revenue from COVID‑19 products is declining due to seasonal shifts and competition, but market share remains relatively steady. The narrative suggests a maturing market with lower volumes yet consistent competitive performance.

Flu‑COVID Combination Vaccine Approval Challenges and Launch Delays

Q2 2024 noted positive immunogenicity data with initial regulatory engagement, Q3 2024 discussed plans for a 2026 launch due to timing issues, and Q4 2024 highlighted delays stemming from the need for additional flu efficacy data and regulatory uncertainties. " " " "

Q1 2025 confirmed that additional flu vaccine efficacy data required by the FDA has extended review timelines into 2026, underscoring ongoing regulatory challenges and uncertainty in launching this product on time. " " "

Persistent regulatory hurdles and extended review timelines remain a consistent challenge. The delay in achieving an approved launch—in particular for the flu component—means that revenue contributions from this product remain deferred, reinforcing a cautious revenue outlook.

CMV Vaccine Efficacy, Durability, and Cost Efficiency

Across Q2 and Q3 2024, the CMV vaccine was discussed in terms of interim analyses and challenges in meeting early efficacy criteria (with optimism for final results), as well as discussions on durability and the broader cost efficiency strategy. " " " " "

In Q1 2025, Moderna highlighted exceptionally strong durability data (robust antibody levels maintained for three years) and ongoing Phase III efficacy studies with final analysis expected later in 2025; cost efficiency efforts are also emphasized as respiratory trials wind down. " " " "

Although interim efficacy signals remain mixed, the strong durability profile is consistently praised. Cost efficiency initiatives, especially related to R&D and winding down expensive respiratory trials, are reinforcing a pathway to lower expenses in the future.

RSV Vaccine Development and Competitive Positioning

Discussed in Q2 2024 (with approvals and ACIP recommendations), Q3 2024 (with positive safety and immunogenicity data and early filing details) and Q4 2024 (with a PDUFA date of June 12, 2025, and low initial sales of mRESVIA). " " " " "

Q1 2025 updates announced expanded regulatory approvals across regions (Australia, U.K., Taiwan, Switzerland), targeting high‐risk adults and hinting at improved competitive positioning compared to previous periods. " "

There’s an accelerating progression in regulatory filings and market expansion internationally. Although early sales were modest in previous periods, the improved competitive positioning and multi-region approvals suggest a stronger future contribution.

Regulatory Uncertainty and Approval Delays

Q3 2024 mentioned ongoing discussions on the combination vaccine with considerations for timing and international regulatory complexities; Q4 2024 detailed uncertainties regarding flu efficacy readouts and exclusion of new product revenue in guidance; Q2 2024 touched on ongoing regulatory engagement without explicit political risk at that time. " " " " "

In Q1 2025, the call reiterated delays for the flu‑COVID combination due to additional data requirements, noted uncertainties in COVID strain selection, and acknowledged political commentary—which they dismissed as not impacting their scientific process. " " "

Regulatory uncertainty continues to be a recurring challenge with similar narratives over time. Although political risks are acknowledged, the company stresses that scientific data drives decisions, maintaining a consistent yet cautious approach to product approvals and future revenue expectations.

Cost Efficiency Initiatives and R&D Expense Reduction

Q2 2024 demonstrated SG&A reductions, manufacturing cost improvements, and early signs of wind-down costs related to respiratory trials; Q3 2024 highlighted significant declines in cost of sales and outlined plans to reduce annualized expenses by $1.1 billion from 2027; Q4 2024 detailed multi-year cost-saving targets and strategic R&D spending cuts. " " "

Q1 2025 reported a 19% reduction in combined cost areas (cost of sales, R&D, SG&A) with a specific decrease in R&D spending (down 19% YoY) due largely to the wind-down of respiratory trials, with further reductions targeted by 2027. " " " "

Cost efficiency measures have evolved into a systematic approach across periods—consistent reductions, operational streamlining, and a planned wind-down of expensive respiratory trials are driving a long-term reduction in R&D and operating expenses. This remains a major focus that could have a large impact on future profitability.

Financial Health: Cash Position, Revenue Outlook, and International Market Challenges

Q2 2024 showed a robust cash position (~$10.8B) and cautious full‐year revenue guidance impacted by lower volumes and deferrals, Q3 2024 reported declining cash (down to $9.2B) with anticipated revenue challenges due to international market variability, and Q4 2024 described a cash balance of $9.5B with revenue outlook affected by declining COVID sales and international licensing challenges. " " " " "

Q1 2025 reported a further reduction to $8.4B in cash and investments, set 2025 total revenue guidance at $1.5–$2.5B with first‐half sales projected very low, and noted persistent international challenges such as regulatory delays and market deferrals affecting revenue. " " "

While cash remains strong, revenue continues its downward adjustment amid a challenging international landscape and seasonal effects. The consistent pressure from lower vaccination rates and deferred international revenue underpin a cautious financial outlook for the near term, although long‐term recovery is anticipated through new product launches and operational efficiencies.

Safety Concerns and Uncertain Clinical Outcomes in Vaccine Programs

Q4 2024 provided a detailed discussion of the Norovirus vaccine experiencing a GBS case and the resulting clinical hold (later lifted), whereas Q2 and Q3 lacked explicit emphasis on these safety concerns; prior discussions mentioned monitoring safety endpoints uncommon in large populations. " " " " " "

Q1 2025 reiterated monitoring of GBS events in the Norovirus vaccine trial, confirming that no additional cases have been observed and that the clinical hold had been effectively managed, reinforcing the commitment to safety. "

Safety remains a key focus even though significant adverse events are rare. The consistent monitoring and transparent handling of uncommon events (such as a GBS case) indicate robust risk management; although challenges exist, they have not escalated and are being effectively contained.

Legal and Litigation Risks

Q3 2024 was the only period that mentioned legal risks specifically, addressing a GSK lawsuit regarding COVID‑19 vaccine patents and emphasizing that such litigation is common in emerging tech markets. "

In Q1 2025, Q2, and Q4 2024 calls, there were no new or reiterated discussions on legal and litigation risks.

The topic emerged notably in Q3 2024 but was not a consistent focus across other periods, suggesting it is not currently viewed as a major ongoing risk relative to other operational and regulatory challenges.

Emerging mRNA Therapeutics for Pulmonary Diseases

Q2 2024 discussed early-stage research and highlighted the cystic fibrosis collaboration with Vertex was the primary pulmonary focus; Q3 2024 did not mention pulmonary programs; Q4 2024 provided an update on the Vertex collaboration in cystic fibrosis. "

Q1 2025 did not include any update on emerging pulmonary programs, suggesting a temporary lack of new information for this category [no mention].

Pulmonary therapeutics remain in the early or collaborative phases, with periodic updates (as seen in Q2 and Q4) but limited recent commentary in Q1 2025. This area is emerging and may gain significance as additional clinical data become available over time.

Product Launch Timing and Its Impact on Future Revenue

Q2 2024 discussed how the timing of RSV and COVID vaccine launches—with deferrals of revenue and competitive pressures—affected revenue forecasts; Q3 2024 provided detailed perspectives on delayed launches (e.g. flu‑COVID combination expected in 2026) and potential upside from products not included in guidance " " " ; Q4 2024 reinforced caution by excluding new product revenue due to timing uncertainties. " "

Q1 2025 emphasized upcoming PDUFA dates for the next‑gen COVID and RSV vaccines while reiterating that the flu‑COVID combination vaccine remains delayed until 2026, which is reflected in conservative revenue guidance for 2025 (targeting $1.5–$2.5B). " " "

There is a consistent cautious approach to incorporating new product launches into revenue forecasts. Ongoing delays—especially for the flu‑COVID combination—continue to postpone revenue contributions, while upcoming approvals for certain products remain potential growth drivers in future periods.