Analyst Conference Summary

biotechnology

conference date: February 14, 2025 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2024 (fourth quarter, Q4 2024)

Forward-looking statements

Overview: Plunging revenue post Covid. Hopes for pipeline.

Basic data (GAAP):

Revenue was $0.97 billion, down 46% sequentially from $1.86 billion, and down 34% from $2.8 billion year-earlier.

Net income negative was $1.1 billion, down sequentially from $13 million, and down from $217 million year-earlier.

EPS (diluted) was negative $2.91, down sequentially from $0.03, and down from $0.55 year-earlier.

Guidance:

2025 revenue is expected between $1.5 and $2.5 billion. But only $0.2 billion is expected in 1H. Cost of sales $1.2 billion. R&D $4.1 billion. SG&A $1.1 billion. Cap ex $0.4 billion. End of year cash and investments $6 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "We have made progress in 2024 across our late-stage pipeline and cost reduction efforts. Our team successfully filed three Biologics License Applications in the final months of the year and reduced our costs by 27 percent compared to 2023. In 2025, we remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business. By the end of 2025, we aim to remove nearly $1 billion in costs. With strong momentum in our late-stage pipeline, we anticipate multiple approvals starting this year, along with key Phase 3 readouts that will support our long-term growth." Market share was lower, in addition to reduced vaccination rates.

Spikevax sales for Covid were $923 million in Q3. $244 million in U.S. and $679 million international. Moderna plans to file for approval of its next-generation COVID-19 vaccine (mRNA-1283) in Q4 2024.

The FDA approved Moderna's RSV vaccine, mResvia, in May 2024. The EMA recommended marketing authorization in the EU. Deliveries in US began in July. Sales in Q4 2024 were $15 million, up sequentially from $10 million. 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 $9.5 billion, up sequentially from $9.2 billion.

Operating expense (GAAP) of $2.21 billon consisted of $739 million for cost of sales, $1.12 billion for R&D, and $351 million for SG&A. Operating loss was $1.25 billion. $91 million interest income; $29 million other expense. Income tax benefit $64 million.

Q&A Selective Summary:

R&D spend distribution? We believe there is a lot of room, and flexibility, for reduction. Spending is over 50% on respiratory trials, which should roll off in 25-26. Could continue to reduce beyond 2025.

Norovirus clinical hold? GBS happens in backround population, not surprising to see cases in a trial as large as ours. We decided to pause when we learned of it. FDA has us on hold while they do a review, but we had already completed enrollment, so we should release data as expected.

CMV readout? Continuing to accrued cases, blinded, expect results in 2025, not necessarily 1H.

Cancer vaccine timeline? Some differences in population between Phase 2 and Phase 3. Is fully enrolled, events will start to happen, 2016 is plausable, but too early to predict timing.

We have not seen any GBS in the Covid or RSV trials.

CMV interim analysis, going forward? It is very possible that the final analysis will meet expectations. But we are blinded.

Inventory write-downs on seasonal vaccines? We reduced it to $500 million in 2024, which was down from 2023. We also had too much manufacturing capacity. Going forward this issue should look better. But we still have some 2024 product to write off, and are planning production at high end of our 2025 guidance.

CMV case accrual? Event driven, so cannot predict exactly, think around mid-2025.

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