Moderna, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 1 May 2026: press release. Guidance figures: 1 raised, 1 lowered, 5 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue rose to $389 million: Total revenue increased by $281 million from the prior-year quarter, mainly from COVID vaccine sales and deliveries under long-term government partnerships. Source
• Roughly 80% of revenue international: Approximately 80% of first-quarter revenue came from international markets, against $78 million in the U.S. and $311 million in international markets. Source
• Two European approvals announced: Regulators in Europe approved mNEXSPIKE and mCOMBRIAX, the flu plus COVID combination vaccine, and approved mRESVIA for adults aged 18 and older. Source
• R&D fell 24% on program wind-down: Lower clinical and manufacturing costs from the wind-down of large Phase 3 respiratory programs and congenital CMV studies drove the decline, partly offset by COVID postmarketing commitments. Source
• Arbutus settlement resolves litigation worldwide: The company settled with Arbutus Biopharma and Genevant Sciences, ending all related litigation worldwide during the quarter. Source
• Settlement charge drove net loss: The litigation settlement expenses reduced net loss by $0.9 billion in the quarter and reduced loss per share by $2.22. Source
• Cash and investments declined to $7.5B: Cash, cash equivalents and investments were $7.5 billion at March 31, 2026, down from $8.1 billion at December 31, 2025. Source
• Settlement payment due in Q3: The settlement expense did not affect first-quarter cash; the related $950 million payment is expected in the third quarter of 2026. Source
• Phase 3 monotherapy study started: A Phase 3 study of intismeran as monotherapy and with KEYTRUDA QLEX began in high-risk Stage 1 non-small cell lung cancer. Source
• Flu vaccine PDUFA date set: The FDA set a PDUFA goal date of August 5, 2026 for mRNA-1010, the seasonal flu vaccine. Source

“The Moderna team delivered a great start to the year, driving significant revenue growth and substantial cost reductions building on actions taken in 2025.”

Stéphane Bancel, Chief Executive Officer of Moderna

Guidance

What changed from last quarter

• Guidance lowered: Year-end 2026 cash and investments guidance moved to $4.5 to $5.0 billion from $5.5 to $6.0 billion. Source
• Guidance raised: Cost of sales guidance for 2026 raised to about $1.8 billion from about $0.9 billion, with the change tied to the $0.9 billion litigation settlement charge. Source
• Guidance kept: The company reiterated its plan for up to 10% revenue growth and GAAP operating expense reductions in 2026, excluding the litigation settlement charge. Source
• New: The company entered a settlement agreement with Arbutus Biopharma and Genevant Sciences, resolving all related litigation worldwide. Source
• New: European regulatory approvals were received for mNEXSPIKE and mCOMBRIAX, and mRESVIA was approved for all individuals aged 18 and older. Source
• New: A Phase 3 study of intismeran as monotherapy and with KEYTRUDA QLEX was initiated in high-risk Stage 1 non-small cell lung cancer. Source
• New: A Phase 3 study of mRNA-1018, the pandemic influenza vaccine, was initiated with CEPI. Source
• New: The FDA assigned a PDUFA goal date of August 5, 2026 for mRNA-1010, after the prior refusal-to-file letter. Source
• Ended: The decision on a pivotal trial for mRNA-3705 is deferred until the propionic acidemia registrational data readout, replacing the earlier plan to begin a registrational study in 2026. Source

Revenue and growth drivers

• Revenue rose to $389 million: Total revenue increased by $281 million from the prior-year quarter, mainly from COVID vaccine sales and deliveries under long-term government partnerships. Source
• Higher COVID vaccine sales drove growth: Net product sales rose on higher COVID vaccine sales, mostly in international markets, from deliveries under long-term strategic partnerships with government entities. Source
• Management expects return to sales growth: The CEO said the company expects to return to sales growth in 2026 and several additional approvals around the world, including for the seasonal flu vaccine. Source

Regions and partnerships

• Roughly 80% of revenue international: Approximately 80% of first-quarter revenue came from international markets, against $78 million in the U.S. and $311 million in international markets. Source
• UK partnership first shipment delivered: The company delivered the first shipment under its long-term strategic partnership in the UK during the quarter. Source
• Revenue split targeted evenly for 2026: The company expects 2026 revenue to be about half from the U.S. and about half from international markets. Source

“Building on this strong first quarter momentum, we are excited to return to sales growth in 2026 and expect several additional approvals around the world, including for our seasonal flu vaccine, which would be Moderna's fifth approved product.”

Stéphane Bancel, Chief Executive Officer of Moderna

Approvals and product filings

• Two European approvals announced: Regulators in Europe approved mNEXSPIKE and mCOMBRIAX, the flu plus COVID combination vaccine, and approved mRESVIA for adults aged 18 and older. Source
• Combination vaccine approved in EU: The European Commission granted marketing authorization for mCOMBRIAX, while filings for mRNA-1083 remain under review in Canada and Australia. Source
• Flu vaccine filings under review: The mRNA-1010 flu vaccine filings are under review in Europe, Canada and Australia, with potential approvals expected to begin in 2026. Source
• Japanese cohort data presented at congress: Moderna presented mRNA-1083 data from a Japanese cohort at the 2026 ESCMID Global Congress. Source

Operating costs and expenses

• R&D fell 24% on program wind-down: Lower clinical and manufacturing costs from the wind-down of large Phase 3 respiratory programs and congenital CMV studies drove the decline, partly offset by COVID postmarketing commitments. Source
• SG&A fell 18% on lower costs: Lower employee-related expenses, marketing costs and consulting and external services reduced SG&A expenses in the quarter. Source
• Cost of sales included royalties: Cost of sales for the quarter included third-party royalties of $895 million and inventory write-downs of $38 million. Source
• Cost of sales excluding settlement fell: Excluding the settlement expenses, cost of sales declined on lower unutilized capacity costs, firm purchase commitment losses and inventory write-downs, partly offset by higher sales volume. Source

“We also look forward to important pivotal readouts this year for our norovirus, intismeran in melanoma, and propionic acidemia programs.”

Stéphane Bancel, Chief Executive Officer of Moderna

Litigation settlement charge

• Arbutus settlement resolves litigation worldwide: The company settled with Arbutus Biopharma and Genevant Sciences, ending all related litigation worldwide during the quarter. Source
• Settlement charge drove net loss: The litigation settlement expenses reduced net loss by $0.9 billion in the quarter and reduced loss per share by $2.22. Source
• Settlement charge sat in royalties: The $878 million of settlement expenses were recorded within third-party royalties, lifting cost of sales by $865 million year over year. Source

Net loss, cash and balance sheet

• Loss per share was $(3.40): Net loss was $(1.3) billion for the quarter, against a loss per share of $(2.52) in the first quarter of 2025. Source
• Cash and investments declined to $7.5B: Cash, cash equivalents and investments were $7.5 billion at March 31, 2026, down from $8.1 billion at December 31, 2025. Source
• Cash decline from R&D investment: The company attributed the decline in cash mainly to operating losses from continued R&D investment and advancement of its pipeline. Source
• Settlement payment due in Q3: The settlement expense did not affect first-quarter cash; the related $950 million payment is expected in the third quarter of 2026. Source

Oncology and pipeline progress

• Phase 3 monotherapy study started: A Phase 3 study of intismeran as monotherapy and with KEYTRUDA QLEX began in high-risk Stage 1 non-small cell lung cancer. Source
• Five-year melanoma data at ASCO: Five-year Phase 2b adjuvant melanoma data showed intismeran with KEYTRUDA reduced the risk of recurrence or death by 49% versus KEYTRUDA alone; an ASCO presentation is scheduled. Source
• Nine oncology trials underway: Nine Phase 2 and Phase 3 intismeran trials are running across melanoma, lung, bladder and kidney cancers, with several fully enrolled. Source
• MRNA-4359 readout expected 2026: The Phase 2 portion of the mRNA-4359 study covers several melanoma and lung cohorts, with a potential data readout expected in 2026. Source
• MMA pivotal decision deferred: The decision on a pivotal trial for mRNA-3705 in methylmalonic acidemia is deferred until the propionic acidemia registrational data are read out. Source

Vaccine pipeline and regulatory timing

• Norovirus readout subject to cases: The norovirus Phase 3 study is fully enrolled in its second Northern Hemisphere season, with data expected in 2026 subject to case accruals. Source
• Combination vaccine awaits FDA guidance: The company is waiting for further FDA guidance on refiling the flu plus COVID combination vaccine submission in the U.S. Source
• Flu vaccine PDUFA date set: The FDA set a PDUFA goal date of August 5, 2026 for mRNA-1010, the seasonal flu vaccine. Source

Corporate updates and investor events

• Pandemic flu Phase 3 started with CEPI: A Phase 3 study of mRNA-1018, the pandemic influenza vaccine, was started in collaboration with CEPI. Source
• Propionic acidemia data expected 2026: The PA candidate mRNA-3927 is in a registrational study with target enrollment reached, and potential data are expected in 2026. Source
• Investor events scheduled through November: Investor and analyst events are set for June 1 (ASCO), June 25 (Science Day) and November 12 (Analyst Day). Source

Coming up, as management said on 1 May 2026

• Phase 3 adjuvant melanoma data: The company expects Phase 3 adjuvant melanoma data potentially in 2026. Source
• ASCO oral presentation on June 1: An oral presentation of five-year Phase 2b adjuvant melanoma data is scheduled at the 2026 ASCO Annual Meeting. Source
• FDA decision date for flu vaccine: The PDUFA goal date for the mRNA-1010 seasonal flu vaccine is August 5, 2026. Source
• Flu vaccine approvals expected from 2026: Potential approvals for mRNA-1010 in Europe, Canada and Australia are expected to begin in 2026. Source
• Settlement payment in third quarter: The $950 million litigation settlement payment is expected to be made in the third quarter of 2026. Source
• Norovirus data expected in 2026: Norovirus Phase 3 data are expected in 2026, subject to case accruals. Source
• Investor and analyst event dates: Scheduled events are the ASCO investor event on June 1, Science Day on June 25 and Analyst Day on November 12. Source

Risks management discussed

• Regulatory: The company is waiting for FDA guidance on refiling the flu plus COVID combination vaccine submission in the U.S., so the timing of a U.S. filing is not set. Source
• Financial: A $950 million litigation settlement payment is expected in the third quarter of 2026, and year-end cash and investments guidance is now lower. Source
• Operational: The norovirus readout depends on case accruals during the Northern Hemisphere season, so timing of data is tied to how many cases occur. Source

Earlier plans management reported on

• Not stated: The company reiterated this 2026 plan in its first-quarter release. Source
• Not stated: The company continues to expect Phase 3 adjuvant melanoma data potentially in 2026. Source
• Not stated: The decision on the mRNA-3705 pivotal trial is set to follow the propionic acidemia registrational data readout. Source

Other quarters

• Q2 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results
• Q2 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.