Analyst Conference Summary

biotechnology

conference date: July 31, 2026 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2026 (second quarter, Q2 2026)

Forward-looking statements

Overview: Very weak sales, mainly seasonally down quarter.

Basic data (GAAP):

Revenue was $145 million, down 63% sequentially from $389 million, and up 2% from $142 million year-earlier.

Net income negative was $782 million, up sequentially from negative $1.34 billion, and up from negative $825 million year-earlier.

EPS (diluted) was negative $1.97, up sequentially from negative $3.40, and up from negative $2.13 year-earlier.

Guidance:

2026 target is for 10% revenue growth y/y. Year end cash and investments $4.7 to $5.2 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "The second quarter marked another period of strong execution for Moderna as we advanced our pipeline and strengthened our financial profile with an improved 2026 operating expense outlook. In the second half of 2026, we are preparing for the potential approval of mFLUSIVA in the U.S., which would be our fifth approved product, and continue to anticipate important pivotal readouts for our intismeran in melanoma and propionic acidemia programs." Continuing to reduce operating expenses. Moderna expanded its partnership with CEPI to develop an Ebola vaccine.

Revenue for the quarter was about $ million from the U.S. and $ million international.

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.

In Q3 2026 the norovirus vaccine, mRNA-1403 Phase 3 data did not meet criteria for success at the interim analyis, but is ongoing, with an additional cohort enrolled.

In Q2 2026 Moderna, in Brazil, a collaboration was made with a local manufacturer in support of a supply agreement for COVID vaccines. A joint procurement contract with the European Commission on behalf of six countries for up to 24 million doses of mRESVIA was signed. Moderna also received regulatory approvals in Australia and Mexico for mRESVIA and in Japan and Taiwan for mNEXSPIKE.

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 Q2 2026 the investigational seasonal influenza vaccine, mFLUSIVA, received a unanimous recommendation from US Vaccines and Related Biological Products Advisory Committee (VRBPAC) ahead of an August 5 PDUFA date.

In Q2 revenue was $87 million in the U.S. and $58 million international.

In Q2 2026 Moderna received European Commission marketing authorization for mCOMBRIAX (Seasonal flu + COVID vaccine) in the EU. mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. Awaiting further guidance from the FDA on refiling the submission for its flu plus COVID combination vaccine.

The PDUFA date for the seasonal flu vaccine is August 5, 2026.

In Q3 2026 Moderna presented positive five-year Phase 2b adjuvant melanoma data at the 2026 ASCO Annual Meeting. It showed a sustained benefit with intismeran in combination with Keytruda, reducing the risk of recurrence or death by 49%, compared to Keytruda alone. Phase 3 is fully enrolled. Also has several potential cancer therapies in Phase 1 or Phase 2 or preclinical study.

Moderna's mRNA-3927 for proprionic acidemia registrational trial is fully enrolled. Data likely by the end of 2026.

Cash and investments ended the quarter at $6.9 billion, down sequentially from $7.5 billion. Long-term debt $591 million. After the quarter ended Moderna paid $950 million in a litigation settlement.

Operating expense (GAAP) of $960 millon consisted of $93 million for cost of sales, $651 million for R&D, and $216 million for SG&A. Operating loss was $815 million. $67 million interest income; $19 million other expense. Income tax $15 million.

Q&A Selective Summary:

Melanoma, if it passes first interim? Read through to other tumor types? If Phase 3 studies continues, we have not disclosed statistical powering, too early to say, will need to wait for the data. The read through to other cancers depends on strength of results. In other tumors do work, so that gives us reason to believe possible success. Where checkpoints do not work, like pancreatic cancer, it remains to be seen. It is possible that it may be good enough on final analysis, but not good enough on the interim.

Not disclosing timing of results except 2H 2026, for melanoma. If successful we hope for priority review, but that is data-dependent.

Melanoma commercial capability? Facility in Massachusetts should be able to support the first few years of demand.

Flu strain for 2027? Yes, at Advisory Committee and other FDA discussions we could change the strain selection, but that would be made by public health.

INT ASCO data, selection of neoantigens? 29% of neoantigens are immunogenic. 1 to 18 reacted in each patient, but you only need one. We are using AI to try to improve this. Next we need an efficacy readout to correlate with the algorithm.

Flu vaccine pricing? Conversations are ongoing. Believe our product is better than the current standard. Will discuss with payers.

Norovirus? Study is blinded and continuing. We will need additional cases to strengthen the statistical analysis.

Intismeran in low TMRCC? No data from that trial yet, but should have some data later in 2026 in other tumors like pancreatic cancer. So we have hopes for RCC as well. Partly based on TMB high v. TMB low melanoma data.

T-cell engager program? 2808, multiple myeloma has a number of T-cell engagers. We have 3 T-cell engagers in a single product. For patients who have no other options available. Looking for responses and durability.

The Phase 3 melanoma study, designed by Merck, follows patients a minimum of 18 months, based on the earlier need of 12 months for separation. So that gives us more confidence in the outcome.

Pricing process is going on in the European nations for the combination vaccine. So should see some revenue contribution in 2027, but main ramp will be in 2028.

Second half should see higher US v. ex-US revenue. Depends on shipping dates. But US demand is the biggest variable, as vaccination rates are likely to decline.

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