Analyst Conference Summary

biotechnology

conference date: May 1, 2025 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2025 (first quarter, Q1 2025)

Forward-looking statements

Overview: Plunging revenue post Covid. Hopes for pipeline.

Basic data (GAAP):

Revenue was $0.1 billion, down 90% sequentially from $0.97 billion, and down 58% from $0.17 billion year-earlier.

Net income negative was $0.97 billion, up sequentially from negative

EPS (diluted) was negative $2.52, up sequentially from negative

Guidance:

unchanged. Year end cash down to $6 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "In the first quarter, we continued to execute with financial discipline, significantly reducing our operating expenses, and further prioritized our investments in oncology. Looking ahead, we are reiterating our 2025 financial framework and announcing a cost structure that is expected to reduce our annual operating expenses by approximately $1.5 billion by 2027. With several Phase 3 readouts approaching and continued momentum toward 10 product approvals, we remain confident in Moderna's long-term outlook." Vaccine business is now highly seasonal. Focus on cost reductions.

Spikevax sales for Covid were $84 million in Q1. $29 million in U.S. and $56 million international. Moderna filed for approval of its next-generation COVID-19 vaccine (mRNA-1283) in Q4 2024, PDUFA May 31, 2025.

Filed for next generation RSV vaccine (mRNA-1345) for high-risk adults aged 18-59 in Q4 2024, PDUFA is June 12, 2025. Believes sales can grow in future years. $2 million in mRESVIA sales, all outside the U.S.

In Q4 2024 fully enrolled a Phase 3 trial for norovirus, mRNA-1403. But had one case of GBS (Guillain-Barré syndrome), so on hold while FDA evaluates. GBS may not be related to vaccine use.

In Q3 initiated a Phase 3 trial for influenza (flu), mRNA-1010. Data expected mid-2025.

In Q4 2024 filed with FDA for approval of combination Flue and Covid vaccine. But may require more data from the flu vaccine study. Now sees potential approval in 2026.

In Q4 2024 the cytomegalovirus (CMV) vaccine (mRNA-1647) Phase 3 study became fully enolled. Efficacy data expected in 2025.

The mRNA-4157 (Intismeran autogene) individualized neoantigen therapy Phase 3 melanoma study is fully enrolled as of Q1 2025. The Phase 2 muscle invasive bladder cancer study, Phase 2 adjuvant renal cell carcinoma, NSCLC, and high risk non-muscle invasive bladder cancer studies are enrolling or fully enrolled.

Expanded oncology program to include mRNA-4359, Checkpoint AIM-T. Now in Phase 2 for melanoma and NSCLC.

Six programs are now in Phase 3. By end of 2025 expects commercial sales of Covid, Flu, RSV. Then a whole bunch of possible approvals in 2026, including in cancer and rare diseases.

Cash ended the quarter at $8.4 billion, down sequentially from $9.5 billion.

Operating expense (GAAP) of $1.16 billon consisted of $90 million for cost of sales, $856 million for R&D, and $212 million for SG&A. Operating loss was $1.05 billion. $90 million interest income; $4 million other expense. Income tax benefit $7 million.

Q&A Selective Summary:

Flu + Covid timeline extension? The flu study readout should come soon, that would become part of the review. We already demonstrated efficacy for the Covid part. After we submit the results the timeline will need to be extended. FDA interactions have been business as usual.

We think the need for Covid vacinations this fall is real. Saw thousands of deaths a week last winter, mostly older patients who were unvacinated.

INT plans, timeline? Melanoma reached target enrollment last year. Events for first analysis likely to be in 2026. No updates for other indications except as announced. We may expand to monotherapy spaces. Checkpoint data will be shared at a medical meeting. Will add additional histologies in the future.

Requirement to run vaccine trials against placebo? We have not heard that directly. All our major studies were placebo controlled, or had an earlier placebo controlled study. We will do as we are guided.

Covid strain updates? That is decided by regulatory bodies. We expect within the next month to hear what they expect us to deliver for this fall.

Norovirus GBS case followup? Clinical hold has been lifted, so we satisfied questions. We have not seen an additional GBS case. We may never know the cause, it is something in the background population, so we see it in placebo arms of trials.

Q1 Covid revenue v. Pfizer? The script data was 38% market share for us, similar to last year. We see continuation through the first half. Customer inventory levels have been managed down.

Our take on the CMV meeting was that the demand for an effective vaccine is high.

RFK single antigen vaccine statements? You would need to ask him. Our products have demonstrated efficacy through clincial trials, including our single-antigen products. We also do have multiple antigen products.

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