Analyst Conference Summary

biotechnology

conference date: May 1, 2026 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2026 (first quarter, Q1 2026)

Forward-looking statements

Overview: Loosing much money, cost of sales much higher than product revenue.

Basic data (GAAP):

Revenue was $389 million, down % sequentially from $678 million, and up 260% from $108 million year-earlier.

Net income negative was $1.34 billion, down sequentially from negative $826 million, and down from negative $971 million year-earlier.

EPS (diluted) was negative $3.40, down sequentially from negative $2.11, and down from negative $2.52 year-earlier.

Guidance:

2026 revenue is expected up 10% over 2025 revenue, with 50% each from U.S. and international. Cap ex $200 to $300 million. Year end cash $4.5 to $5.0 billion. Expects declining Covid vaccination rates.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "The Moderna team delivered a great start to the year, driving significant revenue growth and substantial cost reductions building on actions taken in 2025. We received two product approvals in Europe, including the world's first flu plus COVID combination vaccine, mCOMBRIAX. We also started a new pivotal trial for intismeran-our first Phase 3 monotherapy study for high-risk Stage 1 non-small cell lung cancer patients. 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. We look forward to important pivotal readouts this year for our norovirus, intismeran in melanoma, and propionic acidemia programs." Revenue came in above guidance.

Revenue for the quarter was about $78 million from the U.S. and $311 million international. Mostly from the Covid vaccine (spilevax or mNexspike). mNexspike sales should increase in 2026 largely due to international adoption.

In Q1 2026 the norovirus vaccine, mRNA-1403, is in Phase 3, fully enrolled, with data expected in 2026.

Cost of sales of $955 million included third-party royalties, at $895 million, mostly driven by a litigation settlement, and inventory write downs of $38 million. But the cash outlay of $950 million will be made in Q3 2026.

For seasonal flu, mRNA-1010 regulatory filings are under review in Europe, Canada and Australia with potential approvals are expected to begin in 2026. The U.S. FDA PDUFA goal date for mRNA-1010 is August 5, 2026. Also started the Phase 3 study of mRNA-1018, a pandemic influenza vaccine, in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI).

For norovius, the Phase 3 trial of mRNA-1403 is fully enrolled, with data likely in 2026.

In Q1 2026 the Phase 3 trial for mRNA-4157 (Intismeran autogene) for adjuvant melanoma is fully enrolled, led by Merck. Two NSCLC Phase 3 trials are enrolling. Several Phase 2 trials in other indications are fully enrolled or underway. In Q1 2026 Moderna and Merck recently announced positive five-year Phase 2b adjuvant melanoma data, which showed intismeran autogene in combination with Keytruda reduced the risk of recurrence or death by 49% compared to Keytruda alone. Believed intismeran could see a commercial launch in 2027. In Q1 2026 completed enrollment in adjuvant muscle invasive bladder cancer.

In Q1 2026 the Propionic acidemia study of mRNA-3927 is in a fully-enrolled registrational study with a potential data readout in 2026. in Q1 2026 entered a global commercialization agreement with Recordati.

In Q1 2026 the Phase 1/2 study of mRNA-4359, a cancer antigen therapy, was ongoing. mRNA-4359 data was presented at the (AACR) 2026 Annual Meeting. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC. A potential Phase 2 data readout expected in 2026.

In Q2 2026 Moderna entered into a settlement agreement with Arbutus Biopharma Corporation and Genevant Sciences GmbH resolving all litigation worldwide. Thus the $950 million lump sum payment. Further loss could be avoided if Moderna wins an appeal re revenues not included in calculating the first payment.

Cash ended the quarter at $7.5 billion, sequentially from $8.1 billion. Long-term debt $590 million.

Operating expense (GAAP) of $1.78 billon consisted of $955 million for cost of sales, $649 million for R&D, and $173 million for SG&A. Operating loss was $1.39 billion. $72 million interest income; $18 million other expense. Income tax $9 million.

Q&A Selective Summary:

New Phase 3 NSCLC combo therapy? Merck excited by Phase 2 data, both efficacy and tolerability. Question is can intismeran do these benefits as monotherapy and adjuvant monotherapy Stage 1 NSCLC. We are very excited to see the potential.

International contracts, UK, timing? Delivery in Q1 is for the UK spring campaign for high risk patients. Will be a second campaign, and delivery, for the autumn.

Adjuvant melanoma timeline? Interim analysis in 2026. Not a built-in futility analysis. Well-powered study, accrual has been balanced. We could declare early success, or continue the trial.

New CBER director, interactions? Normal interactions with FDA so far. We do not normally interact with senior staff.

Legal trial result timeline hard to predict, could be 2027 or 2028.

Bladder cancer, RCC trials? Both those Phase 2 studies are fully enrolled, about 200 per. We are looking for a meaningful clinical benefit. Blinded, accruing events, could be registrational studies. So hard to guide to when we will have results. RCC is far from melanoma in mutational burden.

Discussed recognition of revenue, if commercial, of intismeran, from Merck.

Could intismeran be combinded with regimens besides Keydruda? We could look at that in subsequent studies, could also do with 4359, for example.

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