Q2 2024 Earnings Summary
- Moderna expects to have $9 billion in cash next year and plans to return to growth in 2025 by launching new products like the RSV vaccine, indicating a strong financial position and future growth prospects.
- Moderna maintained approximately 50% market share in the U.S. COVID vaccine market last year and is confident in the overall performance of its U.S. business despite increased competition, demonstrating strong market presence.
- Moderna is advancing mRNA therapeutics for pulmonary diseases, including a cystic fibrosis program partnered with Vertex, highlighting potential future growth opportunities in new therapeutic areas.
- Moderna has lowered its 2024 revenue outlook to $3.0-$3.5 billion due to very low expected sales from EU member states and potential revenue deferrals into 2025, indicating demand challenges for its COVID-19 vaccine in key markets.
- Increased competitive pressures are leading to a slower-than-anticipated ramp of their RSV vaccine, with the company admitting that "this year is not turning out as we expected" and acknowledging lower 2024 market share due to being third to market and existing competitor contracts.
- The company expects a $4 billion decrease in cash in 2024, from $13 billion at the start of the year to $9 billion by year-end, highlighting significant cash burn and raising concerns about future cash flow and the ability to fund operations without affecting R&D and SG&A expenses.
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Cash Balance Guidance
Q: How can you maintain year-end cash guidance despite lower revenue?
A: Management remains confident in ending the year with $9 billion in cash , due to factors like revenue deferrals (some cash already collected), effective working capital management, and having a cushion entering the year. -
Guidance Cut Breakdown
Q: How much of the guidance cut is from COVID vs. RSV?
A: The guidance reduction is equally driven by three factors: deferrals (all related to COVID), EU issues (COVID), and competitive pressures in respiratory vaccines, which is split between COVID and RSV. -
OpEx and Cash Outlook
Q: Will cash guidance change, and is flexing OpEx a priority?
A: Despite the cash decrease from $13 billion to $9 billion this year , management expects cash to remain $6–$7 billion by end of 2025. They are focused on OpEx but do not plan significant changes. -
Competitive Pressures
Q: How are competitive pressures affecting RSV and COVID outlook?
A: There's increased competition due to bundling by larger competitors, aggressive pricing, and marketing activities. For RSV, being third to market and only participating in the second half impacts share. They anticipate better market share in 2025. -
RSV Market Potential
Q: How does ACIP's one-and-done RSV recommendation affect market potential?
A: Management wasn't surprised ; they believe revaccination may be needed as protection wanes over time. They expect public health recommendations to evolve, potentially supporting booster doses in the future. -
RSV Market Size Expectations
Q: Is the RSV market smaller than prior estimates?
A: While on paper the market seems smaller, clearer guidelines may improve uptake. They believe the patient population is still sizable, and vaccination rates may be similar or slightly higher than last year. -
Cancer Vaccine Progress
Q: What's the status of the Phase III melanoma vaccine trial and manufacturing?
A: Enrollment is progressing briskly; they expect to conclude soon but haven't provided a specific date. Manufacturing has made great progress, with the Marlboro facility able to produce at commercially relevant volumes. -
CMV Vaccine Timing
Q: When can we expect interim results from the Phase III CMV study?
A: Interim analysis could happen this year, including the required median safety follow-up. There's no change to prior guidance. -
Orphan Disease Programs
Q: What's the regulatory path for MMA and PA programs?
A: Early conversations are ongoing. In MMA, they see promising biomarker movement and are working on validating it with regulators. In PA, lacking a clear biomarker, they're focusing on clinical event rates and discussing approaches with FDA. -
COVID Vaccination Impact
Q: Will the summer COVID wave affect fall vaccinations?
A: The summer wave doesn't change their outlook; they expect vaccination rates to be similar to last year. Protection for the higher-risk winter season remains crucial. -
Pulmonary Delivery Indications
Q: Are there additional indications for pulmonary delivery being explored?
A: They acknowledge many pulmonary diseases could benefit but are in early research stages. Current partnership with Vertex is limited to cystic fibrosis.
Research analysts covering Moderna.