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 $ billion, down % sequentially from $0.97 billion, and down % from $ billion year-earlier.

Net income negative was $ billion, down sequentially from negative

EPS (diluted) was negative $, down sequentially from negative

Guidance:

Conference Highlights:

Stephane Bancel, Moderna's CEO, said ""

Spikevax sales for Covid were $ million in Q1. $ million in U.S. and $ million international. Moderna filed for approval of its next-generation COVID-19 vaccine (mRNA-1283) in Q4 2024.

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.

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.

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

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

The mRNA-4157 individualized neoantigen therapy Phase 3 melanoma study is fully enrolled as of Q1 2025. The Phase 2 muscle invasive bladder cancer study and Phase 2 adjuvant renal cell carcinoma studies are enrolling.

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

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

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

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