Analyst Conference Summary

biotechnology

conference date: November 7, 2024 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2024 (third quarter, Q3 2024)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $1.86 billion, way up sequentially from $241 million, and up 2% from $1.83 billion year-earlier.

Net income was $13 million, up sequentially from negative $1.28 billion, and up from negative $3.63 billion year-earlier.

EPS (diluted) was $0.03, up sequentially from negative $3.33, and up from negative $9.53 year-earlier.

Guidance:

Full 2024 expected product sales of $3.0 to $3.5 billion. End of year cash $9 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "During the third quarter, we focused on execution with the launch of our updated COVID-19 and RSV vaccines in markets across the globe. I am pleased with the cost efficiency we achieved in the quarter, tracking ahead of where we planned to be at this time. Looking into the fourth quarter and preparing for 2025, we remain focused on driving sales growth, delivering 10 product approvals over the next three years, and continuing to reduce our cost structure." 2024 Covid shots are not trending below 2023 levels in the U.S. retail market. Moderna has a 40% share of that market. Cost of sales decreased dramatically y/y.

Spikevax sales for Covid were $1.8 billion in Q3. $1.2 billion in U.S. and $0.6 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 Q3 2024 were $10 million. Plans for file for next generation RSV vaccine (mRNA-1345) for high-risk adults aged 18-59 in Q4 2024.

In Q3 initiated a Phase 3 trial for norovirus, mRNA-1403.

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

Six programs are now in Phase 3. By end of 2025 expects commercial sales of Covid, Flu, RSV, and Covid/Flu combo vaccines. CMV mRNA-1647 Phase 3 efficacy possible in 2024. Then a whole bunch of approvala in 2026, including in cancer and rare diseases.

Moderna's CMV (cytomegalovirus) vaccine (mRNA-1647) has fully enrolled its Phase 3 trial, with data expected before the end of 2024. Collaboration with Merck.

In Q3 2024 mRNA-4157 started a Phase 3 trial for certain NSCLC, in combo with Keytruda.

Cash ended the quarter at $9.2 billion, down sequentially from $10.8 billion.

Operating expense (GAAP) of $1.93 billon consisted of $514 million for cost of sales, $1.14 billion for R&D, and $281 million for SG&A. Operating loss was $70 million. $103 million interest income; $12 million other loss. Income tax $8 million.

Q&A Selective Summary:

International revenue sources? U.K., Canada, Australia, Brazil are the largest buyers. Expects to decline some in 2025 but then uptick in 2026. We expect to add products over time.

CMV data release? If unblinded, would be because we met the efficacy goal. Not unblinding could mean waiting for final data for statistical significance. Accrual has been steady so far.

We are not yet including any revenue from the priority review therapies in our 2025 guidance.

Reserve return assumption? Released about $140 million in the quarter. Continue to monitor the rate for this season.

RSV market size, competition? Much slower than last year, lower than anticipated. Will be interesting to see what happens in Q1. Quite a bit of volume in channel, it could take quite some time to go through that inventory. We are working on getting approvals outside the US.

Q4/Q3 Covid? Various channels. Sales came earlier this year, are off peak. We are working on campaigns to educate to generate more sales. It is still early in the season. Product sales timing is pre actual vaccinations.

Change of administration possible effects? We work closely with governments around the world. We worked closely with Trump in his first term. We will continue to do that.

We are discussing with Merck additional Phase 3 programs for INT (individualized neoantigen therapy).

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: