Earnings summaries and quarterly performance for Moderna.
Executive leadership at Moderna.
Stéphane Bancel
Chief Executive Officer
Jacqueline Miller
Chief Medical Officer
James Mock
Chief Financial Officer
Jerh Collins
Chief Technical Operations and Quality Officer
Kate Cronin
Chief Brand Officer
Rose Loughlin
Executive Vice President, Research
Shannon Thyme Klinger
Chief Legal Officer and Corporate Secretary
Stephen Hoge
President
Tracey Franklin
Chief People and Digital Technology Officer
Board of directors at Moderna.
Research analysts who have asked questions during Moderna earnings calls.
Courtney Breen
AllianceBernstein
6 questions for MRNA
Huidong Wang
Barclays
6 questions for MRNA
Salveen Richter
Goldman Sachs
6 questions for MRNA
Luca Issi
RBC Capital Markets
5 questions for MRNA
Tyler Van Buren
TD Cowen
5 questions for MRNA
Eliana Merle
UBS
3 questions for MRNA
Myles Minter
William Blair & Company
3 questions for MRNA
Cory Kasimov
Evercore ISI
2 questions for MRNA
Cory William Kasimov
Evercore
2 questions for MRNA
Edward Tenthoff
Piper Sandler Companies
2 questions for MRNA
Geoff Meacham
Citigroup Inc.
2 questions for MRNA
Jessica Five
JPMorgan Chase & Co.
2 questions for MRNA
Michael Yee
Jefferies
2 questions for MRNA
Terence Flynn
Morgan Stanley
2 questions for MRNA
Adi on
Evercore ISI
1 question for MRNA
Chris
Morgan Stanley
1 question for MRNA
Dina Elmonshed
Jefferies Financial Group
1 question for MRNA
Ellie Merle
UBS Group AG
1 question for MRNA
Evan Wang
Guggenheim Securities
1 question for MRNA
Greg Wiessner
TD Cowen
1 question for MRNA
Jarvi On
Citigroup
1 question for MRNA
Jessica Fye
JPMorgan Chase & Co.
1 question for MRNA
Manuel Smithers
Deutsche Bank
1 question for MRNA
Mike Yee
Jefferies
1 question for MRNA
Simon Baker
Redburn Atlantic
1 question for MRNA
Solve
RBC Capital Markets
1 question for MRNA
Timothy Anderson
BofA Securities
1 question for MRNA
Recent press releases and 8-K filings for MRNA.
- On Feb. 3, FDA issued a refusal-to-file letter for Moderna’s mRNA-1010 seasonal influenza vaccine, citing its Phase 3 trial’s use of a standard-dose comparator rather than the high-dose comparator recommended for older adults.
- Moderna said this is the first refusal-to-file letter received in a vaccine review and noted the trial met endpoints showing 26.6% greater effectiveness versus the standard vaccine.
- The company has requested a meeting with the FDA to seek a pathway forward and warned the refusal could hinder U.S. vaccine innovation; shares fell 7% in after-hours trading.
- The FDA’s CBER issued an RTF letter for the BLA of mRNA-1010, citing the use of a licensed standard-dose comparator instead of a best-available standard-of-care comparator, without raising any safety or efficacy concerns.
- This decision conflicts with prior CBER guidance during pre-Phase 3 and pre-submission consultations, which had agreed to Moderna’s comparator choice; the company has requested a Type A meeting to clarify the basis for the refusal.
- mRNA-1010 is still under review in the EU, Canada, and Australia, with additional filings planned in 2026 and potential approvals expected in late 2026 or early 2027.
- Moderna does not expect the RTF letter to affect its 2026 financial guidance.
- FDA is accelerating precision biologics, favoring mRNA platforms, with multiple January 2026 breakthrough designations fueling the shift in oncology.
- Moderna’s Phase 2b KEYNOTE-942/mRNA-4157-P201 five-year follow-up shows a 49% reduction in risk of recurrence or death versus KEYTRUDA alone in high-risk melanoma.
- The safety profile of intismeran autogene plus KEYTRUDA remains consistent with previous reports.
- Moderna and Merck are advancing eight Phase 2/3 trials across melanoma, non-small cell lung, bladder and renal cancers, with the Phase 3 INTerpath-001 melanoma study now fully enrolled.
- Moderna will not fund new late-stage (Phase III) infectious-disease vaccine trials, citing a shrinking U.S. market, regulatory slowdowns and rising anti-vaccine sentiment.
- The company is reallocating resources to oncology and rare-disease mRNA programs, planning to invest COVID-19 vaccine earnings into these areas and highlighting personalized cancer vaccine intismeran with Merck’s Keytruda as a near-term revenue driver.
- Moderna has discontinued programs for congenital cytomegalovirus, herpes simplex virus, Varicella-Zoster virus and Von Gierke disease, and cut ~10% of its workforce (~5,000 employees), aiming to reduce annual operating expenses by $1.5 billion by 2027.
- U.S. vaccine policy shifts under HHS Secretary Robert F. Kennedy Jr. — including removing COVID-19 from routine immunization guidelines and cancelling 22 mRNA projects — have compounded market headwinds.
- 2025 revenue of $1.9 billion, beating the $1.62 billion guidance and exceeding midpoint by $100 million.
- Cash costs reduced to $4.3–4.5 billion in 2025 from $6.3 billion in 2024.
- Year-end liquidity of $8.1 billion cash plus $900 million undrawn credit, totaling $9 billion.
- 2026 targets up to 10% sales growth, driven by U.K./Canada/Australia manufacturing partnerships and mRESVIA launch.
- Key 2026 catalysts include mRNA-4157 phase 3 interim data, flu/flu-COVID submissions, norovirus phase 3 readout, and PA rare disease phase 3 data.
- 2025 sales of $1.9 B, beating guidance midpoint by $100 M; cash costs reduced from $6.3 B to $4.3–4.5 B, and year-end cash & equivalents of $7.6 B (liquidity $9 B)
- Targets up to 10% revenue growth in 2026, led by government-backed manufacturing partnerships in the UK, Canada & Australia and strong uptake of higher-efficacy COVID vaccine mRESVIA (24% retail, 32% elderly share in US)
- Plans multiple 2026 pipeline catalysts, including interim Phase 3 adjuvant melanoma readout for mRNA-4157, Phase 2 data for mRNA-4359 in metastatic lung & melanoma, norovirus Phase 3 results, and Phase 3 PA rare disease readout by year-end
- Emphasizes disciplined cost management, with R&D sunsetting and SG&A flat, aiming for cash break-even by 2028
- 2025 pre-audited sales of $1.9 billion exceeded guidance midpoint by $100 million; cash costs reduced from $6.3 billion in 2024 to $4.3–4.5 billion in 2025, delivering nearly $2 billion in savings
- Ending 2025 cash and cash equivalents totaled $8.1 billion, with an overall liquidity position of $9 billion including undrawn credit facility capacity
- For 2026, Moderna targets up to 10% sales growth, driven by geographic partnerships in the UK, Canada and Australia, and launches of higher-efficacy COVID and flu products
- Multiple 2026 pipeline catalysts include phase III readouts for mRNA-4157 (with Keytruda), mRNA-4359 phase II expansion in metastatic indications, and a potential norovirus readout
- Moderna expects 2025 revenue of approximately $1.9 billion, $100 million above prior midpoint, and has improved GAAP operating expenses to $5.0–$5.2 billion.
- Year-end 2025 cash, cash equivalents and investments of approximately $8.1 billion, including a $0.6 billion drawdown on its term loan facility.
- Reiterates up to 10% revenue growth target for 2026 and forecasts $4.9 billion in GAAP operating expenses.
- Anticipates potential first approvals of flu and flu/COVID combination vaccines and pivotal trial data readouts in oncology, rare disease and infectious disease in 2026.
- Closed a five-year $1.5 billion term loan facility with Ares Management Credit Funds.
- Moderna projected 2025 revenue of $1.6–2.0 billion, reflecting strengthened seasonal vaccine demand.
- Launched mNEXSPIKE mid-year, achieving 24 percent share of U.S. retail COVID vaccinations and bringing its approved commercial portfolio to three products.
- Secured a non-dilutive $1.5 billion five-year term loan and expects $4.2 billion in cash costs for 2026, continuing disciplined cost management.
- Forecasts up to 10 percent revenue growth in 2026, driven by geographic expansion, new product launches and nine anticipated oncology readouts.
- Moderna has filed regulatory applications for its mRNA-1010 seasonal influenza vaccine for adults 50+ with the FDA, EMA, Health Canada and Australia’s TGA, supported by Phase 3 data.
- In Phase 3 trials, mRNA-1010 demonstrated 26.6% relative efficacy in adults 50+ (and 27.4% in those 65+) with a favorable safety profile and superior immune responses versus high-dose and standard vaccines.
- The company faces declining revenues and negative margins — trailing twelve-month sales of $2.202 billion and a net margin of -141.51% — and has secured a $1.5 billion term loan, targeting cash breakeven by 2028 after cost cuts.
- Approval of mRNA-1010 could strengthen Moderna’s respiratory vaccine portfolio, stabilize revenue and support growth prospects into 2027 and beyond.
Quarterly earnings call transcripts for Moderna.
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