Analyst Conference Summary

biotechnology

conference date: August 1, 2025 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2025 (second quarter, Q2 2025)

Forward-looking statements

Overview: Plunging revenue post Covid. Hopes for pipeline.

Basic data (GAAP):

Revenue was $142 million, up 42% sequentially from $100 million, and down 41% from $241 million year-earlier.

Net income negative was $825 million, up sequentially from negative $0.97 billion, and up from $1.28 billion year-earlier.

EPS (diluted) was negative $2.13, up sequentially from negative $2.52, and up from $3.33 year-earlier.

Guidance:

Reduced 2025 full year revenue estimate by 300 million to $1.5 to $2.2 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said ""In the last three months, we advanced our pipeline with positive Phase 3 flu vaccine efficacy data and expanded our commercial portfolio with three new U.S. FDA approvals to drive future sales growth. Today, we are updating our 2025 financial framework, reducing the high end of this year's expected revenue range by $300 million due to the timing of shipments. We continue to operate with financial discipline and are improving expected annual operating expenses in 2025 by approximately $400 million. Looking forward, we have important catalysts over the next six months across our infectious disease and oncology programs that will help us deliver on the promise of our mRNA platform for patients" Vaccine business is now highly seasonal. Moderna announced an organizational restructuring to reduce its global workforce by approximately 10%. Anticipates headcount of under 5,000 by year-end.

Spikevax sales for Covid were $114 million in Q2. $88 million in U.S. and $26 million international. Moderna filed for approval of its next-generation COVID-19 vaccine (mRNA-1283) in Q4 2024, approved in May 2025.

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 Q2 2025 announced positive Phase 3 results for its seasonal flu vaccine. Preparing to file with FDA.

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

The Ctyomegalovirus vaccine Phase 3 data should be available by the end of 2023.

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.

In Q2 2025 the EU approved the updated Covid-19 vaccine for the LP.8.1 variant.

Cash ended the quarter at $5.13 billion, down sequentially from $8.4 billion.

Operating expense (GAAP) of $1.05 billon consisted of $119 million for cost of sales, $700 million for R&D, and $230 million for SG&A. Operating loss was $907 million. $81 million interest income; $8 million other income. Income tax $7 million.

Q&A Selective Summary:

CMV changes in secondary endpoints? There is other data, markers of infection, beyond the primary endpoint that indicate its effectiveness. We did this while blinded. Will update documents prior to conducting analysis.

Several cancer studies could read out in the near term, but they are event driven, so no exact timeline, over the next 2 years.

Covid revenue rest of year? U.S. range is $1 to $1.5 billion. Variability is from competitive pressures and vaccination rates. Contracting is complete, as is pricing. We have confidence within the range.

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