Analyst Conference Summary

biotechnology

conference date: May 2, 2024 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2024 (first quarter, Q1 2024)

Forward-looking statements

Overview: Revenue plummeted in Q1 2024. Now waiting for mRNA therapy approvals on non-Covid indications.

Basic data (GAAP):

Revenue was $167 million, down 94% sequentially from $2.81 billion, and down 91% from $1.83 billion year-earlier.

Net income was negative $1.18 billion, down sequentially from $217 million, and down from $79 million year-earlier.

EPS (diluted) was negative $3.07, down sequentially from $0.55, and down from $0.19 year-earlier.

Guidance:

1H 2024 product sales of about $267 million.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "As we anticipate the launches of our Spikevax 2024-2025 formula and RSV vaccine, we are exercising financial discipline and have intensified our focus on building and utilizing AI technologies to further streamline operations and enhance productivity. With 10 late-stage programs, and additional new programs advancing toward pivotal studies, we continue to expect numerous product milestones this year across our vaccines and therapeutics portfolio. This is the start of a banner year for our vaccine platform as we continue to advance mRNA medicines for patients. This is just the beginning." Operating expenses were reduced by $795 million, for Q1, y/y.

In Q3 2023 Moderna submitted its RSV vaccine mRNA-1345 to regulators; potential 1H 2024 approval (PDUFA May 12, 2024) and fall 2024 launch. In Q4 2022 the Phase 3 trial met its primary endpoint. A pediatric trial is fully enrolled. Believes global RSV market is a $10 billion opportunity. Sales by competitors were about $2.5 billion in 2023. Believes single-dose prefilled syringe will give Moderna a market advantage. Believes it is a $10 billion annual global market.

In Q4 Spikevax Covid vaccine sales were $167 million. $100 million U.S., $67 million ex-US. Moderna is also working with the FDA and international regulators to align the timing of flu and COVID-19 vaccine approvals, which is expected to result in higher uptake if Covid vaccines are available sooner and offered at the same time as the flu shot for the fall of 2024.

Moderna's flu vaccine had positive results in three Phase 3 trials. Discussing with regulators, intends to file for commercial approval in 2024. [But seems the timeline means will miss the 2024 flu season. - WM] Also the flu + Covid vaccine Phase 3 trial is fully enrolled, with data expected in 2024.

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.

The cancer therapies, co-developed with Merck, are refered to as INTs (Individualized Neoantigen Therapies). Phase 3 studies include adjuvant melanoma and adjuvant non-small cell lung cancer. Moderna will have an oncology even on June 3, 2024 at 6 PM Central Time.

Moderna currently has 48 mRNA candidates now in development. The goal of the next phase of development is to submit multiple BLAs to the FDA.

Cash ended the quarter at $12.2 billion, down sequentially from $13.3 billion.

Operating expense (GAAP) of $1.43 billon consisted of $96 million for cost of sales, $1.06 billion for R&D, and $274 million for SG&A. Operating loss was $1.27 billion. $120 million interest income; $19 million other loss. Income tax $10 million.

Q&A Selective Summary:

RSV contract strategy? Cannot contract until regulatory approval. But actively engaged with pharmacies and hospitals.

We believe our INT cancer vaccines, combined with Keytruda, can improve results. So we are pursuing adjuvant applications.

RSV guidance for this year? We have no specific guidance for RSV. Accelerated approval makes full enrollment of Phase 3 trial very important. We also need to establish our manufacturing for it.

CMV longevity, boosting? The efficacy data is not in yet. Expect good durability data. Maybe to 10 years. Or a booster might be needed after 5 to 10 years. Hope is 3 dose series will work for a very long period of time. Should have interim efficacy this year.

All of our respiratory therapies are being developed to be refrigerator stable.

May 12 PDUFA date for RSV? Working towards that date. Hopeful, but could take a little bit longer.

Flu/Covid combo, 1083, will a follow-up be necessary after Phase 3 data? Tracking with flu study. Waiting for the data before commenting on filing timing.

Cancer R&D cost? We know what we are spending, but are not disclosing it. Number of indications will be determined jointly with Merck. But plans to keep adding.

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