Analyst Conference Summary

biotechnology

conference date: February 14, 2026 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2025 (fourth quarter, Q4 2025)

Forward-looking statements

Overview: Poor revenue. Pointing to pipeline potential, despite FDA setbacks.

Basic data (GAAP):

Revenue was $678 million, down 34% sequentially from $1.02 billion, and down 30% from $966 million year-earlier.

Net income negative was $826 million, down sequentially from negative $200 billion, and up from negative $1.12 billion year-earlier.

EPS (diluted) was negative $2.11, down sequentially from negative $0.51, and up from negative $2.91 year-earlier.

Guidance:

Full year 2026 revenue expectd up to 10% above 2025, which would be about $2.1 billion. Cash and investments to drop to $5.5 to $6.0 billion. Total GAAP operating expense about $4.9 billion. Capex $0.2 to $0.3 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "In 2025, we sharpened our commercial execution, launched our third product and brought online three international manufacturing sites, while advancing our mRNA pipeline. At the same time, we lowered our annual operating expenses by approximately $2.2 billion, significantly surpassing our cost-reduction targets. We entered the new year with strong momentum despite the continued challenging environment in the U.S., poised to deliver up to 10 percent revenue growth through mNEXSPIKE expansion and our international strategic partnerships. We look forward to delivering multiple potential product approvals and late-stage clinical readouts, while driving continued innovation across our mRNA platform." Complained about uncertainty created by Trump/Kennedy FDA.

Revenue for the quarter was about $0.3 billion from the U.S. and $0.4 billion international. Mostly from the Covid vaccine (spilevax or mNexspike), about $100 million from other products. mNexspike sales should increase in 2026 largely due to international adoption.

In Q1 2026 the mRNA-1083 regulatory filing is under review in Europe and Canada. Moderna is awaiting further guidance from the FDA on refiling the submission for its flu/COVID combination vaccine.

In Q3 2025 announced positive Phase 3 results for its seasonal flu vaccine mRNA-1010. Filed with FDA, EU, Canada, and Australia in early 2026. But the FDA issued a Refusal to File letter.

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

mRNA-4359 Phase 1/2 study for first line metastatic melanoma nad first line mettastatic NSCLC is enrolling, with Phase 2 data readout expected 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 he 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.

The mRNA-3705 Phase 1/2 study for MMA now has a clinical study design. Registrational study initiation expected in 2026.

Cash ended the quarter at $8.1 billion. The year-end balance included a $600 million initial draw on Moderna's $1.5 billion credit facility. Long-term debt $590 million.

Operating expense (GAAP) of $1.54 billon consisted of $452 million for cost of sales, $775 million for R&D, and $308 million for SG&A. Operating loss was $857 million. $70 million interest income; $12 million other expense. Income tax $27 million.

Full year 2025 revenue $1.94 billion, down from $3.24 billion in 2024. Net loss $2.82 billion. EPS negative $7.26.

Q&A Selective Summary:

Flu refuse to file effect? Flu file is under review in Europe, Canada, and Australia. Flu-covid remains under review in Europe. Need FDA type A meeting for path forward. So no timeline yet.

We have 10 large shots on goal to increase revenue over the next few years. Many possible scenarios.

Intismeran? Five histologies under review. Confident melanoma will read out this year. Guidance not specific because other readouts are event driven.

Refiling flu combo? Review in U.S., waiting to see why the flu rejection before filing for combo in U.S. Our 1010 Phase 3 trial was large with a 27% increase over the control. Licensed current therapies had 24% and 30% increase with roughly the same population. We also showed superiority to Fluzone high dose. Ao we had a comprehensive data set in the initial filing.

Outside the US, for 1010, there has been strong advocacy for better strain matching. In Covid better matching has resulted in better efficacy.

There will be an interim analysis on intismeran for melanoma this year. Study is conservatively designed, so we might see success in the first interim. If not, result would come in 2027.

Intismeran OS data? Will be released at a medical conference.

Merck would make the BLA submission for intismeran.

Phase 2 intismeran studies are not powered for submission. Standard of care is evolving. Phase 2 was mainly to see how broadly the therapy might work.

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