Analyst Conference Summary

biotechnology

conference date: November 6, 2025 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2025 (third quarter, Q3 2025)

Forward-looking statements

Overview: Plunging y/y revenue post Covid. Hopes for pipeline.

Basic data (GAAP):

Revenue was $1.02 billion, up 629% sequentially from $142 million, and down 45% from $1.86 billion year-earlier.

Net income negative was $200 million, up sequentially from negative $825 billion, and down from $13 million year-earlier.

EPS (diluted) was negative $0.51, up sequentially from negative $2.13, and up from $0.03 year-earlier.

Guidance:

Increased 2025. Cash and equivalents at year end expected at $6.5 to $7 billion, up from prior. Revenue range now from $1.6 to $2.0 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "We delivered strong commercial and financial performance in the third quarter, supported by Covid vaccine sales following the successful launch of mNexspike and a significant improvement in expected 2025 operating expenses from our ongoing cost-reduction initiatives." Reduced expenses more than expected.

Spikevax/mNexSpike sales for Covid were $971 million in Q3. $781 million in U.S. and $190 million international.

Resvia RSV vaccine had sales of just $2 million in Q3. Filed for next generation RSV vaccine (mRNA-1345) for high-risk adults aged 18-59 in Q4 2024, approved in Q2 2025. Believes sales can grow in future years. Q2 sales insignificant.

In Q3 2025 announced positive Phase 3 results for its seasonal flu vaccine. Preparing to file with FDA, EU, Canada, and Australia in January 2026.

mRNA-4359 Phase 1/2 study for first line metastatic melanoma nad first line mettastatic NSCLC is enrolling.

In Q2 2025 announced positive Phase 3 results for its Flu + Covid vaccine. Withdrew FDA submission, engaging in requirements for resubmitting. Under review in EU.

In Q3 2025 Ctyomegalovirus vaccine mRNA-1647 Phase 3 data was negative for preventing infection during pregnancy, so the program was terminated.

The Phase 3 trial for mRNA-4157 for adjuvant melanoma is fully enrolled, led by Merch. Two NSCLC Phase 3 trials are enrolling. Several Phase 2 trials in other indications are underway. Has 3 other cancer vaccine candidates in or ready for Phase 1.

The Propionic acidemia study of mRNA-3927 had encouraging Phase 1 results and continues.

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

mRNA-1403 for norovirus is enrolling the Phase 3 trial.

Cash ended the quarter at $6.6 billion, down sequentially from $7.5 billion.

Operating expense (GAAP) of $1.28 billon consisted of $207 million for cost of sales, $801 million for R&D, and $268 million for SG&A. Operating loss was $260 million. $73 million interest income; $0 million other income. Income tax $13 million.

Q&A Selective Summary:

What is deprioritized to achieve expense management? Recently was split across R&D and cost of sales. We reduced waste in materials, improved labor force productivity. In research we are executing trials more efficiently, in some cases reducing speed. We have dropped some less promising parts of our pipeline.

Covid vaccine inventory? The end measure is vaccinations. Yes in Q3 we ship to wholesalers, pharmacies, doctors. Vaccination rate is the largest variable, and it is down. We are still in the heart of the vaccination season. We are comfortable with the current range.

CMV color on failure? We only have the topline data. More detail may help us understand what did not work. Pentamer antibody response was hoped would work, looks like they were not the necessary missing piece.

Norovirus timeline, demand? Novovirus epidemiology is hard to predict. We had planned on 2 seasons. With the second season we hope to accrue enough cases. Norovirus burden of disease is well established.

Confidence in cash break even in 2028? Will lay out in detail on analyst day. Will be a mix of cost reduction and increased revenue. We see geographic expansion as a driver.

Deals with pharma? We want to get get some parterships for Phase 3 trials.

Projections, manufacturing contribution? Revised guidance assumes 20% to 40% vaccine rate reductions y/y. We raised bottom end of guidance outside the U.S., based on contracted deliveries. Strategic partnerships, UK shifted to 2026. Canada is up and running, as is Australia.

Rare disease program? We have two compelling Phase 2 programs. We will wait to make further investments until we can break even with current products. We believe the platform can work on a large number of rare diseases, but will wait until after breakeven in 2028.

We expect further reductions in costs, based on sunsetting of larger trials. We will continue to invest in earlier stage trials.

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