• Total Revenue (2024): $3.2 billion, a 53% decline from 2023.
• Net Loss (2024): $3.6 billion compared to $4.7 billion in 2023.
• Net Product Sales (Q4 2024): $0.9 billion, with $0.2 billion in the US and $0.7 billion internationally.
• Net Product Sales (Full Year 2024): $3.1 billion, with $1.7 billion in the US and $1.4 billion internationally.
• Cash and Investments (Year-End 2024): $9.5 billion.
• Cost of Sales (Q4 2024): $739 million, including $238 million noncash charge for contract termination.
• R&D Expenses (Q4 2024): $1.1 billion, a 20% year-over-year decline.
• SG&A Expenses (Q4 2024): $351 million, down 25% year-over-year.
• Loss Per Share (Q4 2024): $2.91 compared to earnings per share of $0.55 in Q4 2023.
• Operating Expenses Reduction (2024): $2.6 billion compared to 2023.
• Projected Total Revenue (2025): $1.5 billion to $2.5 billion.
• Projected Cash Costs (2025): $5.5 billion.

• Warning! GuruFocus has detected 6 Warning Signs with MRNA.

Release Date: February 14, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Moderna Inc (NASDAQ:MRNA) ended 2024 with $9.5 billion in cash and investments, exceeding their anticipated $9 billion.
• The company has prioritized 10 high-value programs expected to drive sales growth and diversification over the next three years.
• Moderna Inc (NASDAQ:MRNA) reported positive Phase III results in four programs and filed for FDA approval for several vaccines, including next-gen COVID and RSV.
• The company achieved a significant reduction in operating expenses, cutting costs by $2.6 billion compared to 2023.
• Moderna Inc (NASDAQ:MRNA) has two commercial products on the market and is focusing on expanding its presence in the RSV market.

Negative Points

• Moderna Inc (NASDAQ:MRNA) reported a net loss of $3.6 billion for 2024, compared to a loss of $4.7 billion in 2023.
• Total revenue for 2024 was $3.2 billion, a 53% decline from 2023, primarily due to lower product sales.
• The company experienced a 66% decline in total revenue for Q4 2024 compared to the same period last year.
• Inventory write-downs and unutilized manufacturing capacity costs remain a challenge, with $600 million in related costs for 2024.
• The Norovirus vaccine trial is on clinical hold in the US due to a single case of Guillain-Barre Syndrome, impacting trial timelines.

Q & A Highlights

Q: Can you help us understand the breakdown of the R&D spend across your program? How much flexibility is there for further cuts in the 2026 time frame? Also, can you provide more details on the clinical hold on Norovirus? A: James Mock, CFO: We have room to reduce R&D spend, with flexibility beyond the $3.6 billion we've indicated. Over 50% of our trial spend is related to respiratory trials, which we expect to roll off soon. Stephen Hoge, President: Regarding Norovirus, GBS occurs in the background population, and we paused activities to prioritize patient safety. The FDA placed us on hold while reviewing our documents, but we don't expect an impact on the study timeline.

Q: What would it take for the FDA to remove the clinical hold on Norovirus? Will the final CMV readout still happen in the first half of 2025? A: Stephen Hoge, President: The FDA needs time to review our submitted materials for Norovirus. We expect minimal impact on trial conduct. For CMV, we continue to accrue cases and expect results in 2025, though specific timing is not confirmed.

Q: Can you provide timing expectations for the INT cancer vaccine and Norovirus trials? A: Stephen Hoge, President: For INT, the timing depends on event accrual rates. 2026 is plausible, but exact timing is uncertain. For Norovirus, the Northern Hemisphere study is fully enrolled, and we may not need Southern Hemisphere participants, but we plan to enroll them for broader epidemiology.

Q: What is the clinical bar for the Norovirus program? Will we get data updates for the INT portfolio beyond melanoma? A: Stephen Hoge, President: For Norovirus, we aim to show a meaningful decrease in moderate to severe gastrointestinal symptoms. We haven't disclosed specific targets yet. For INT, we look forward to the melanoma Phase III readout and will update on other trials as events accrue.

Q: Can you confirm if there have been any GBS cases with your RSV vaccine? What is required for the COVID flu combo vaccine approval? A: Stephen Hoge, President: No GBS cases have been identified with our RSV or COVID vaccines. For the combo vaccine, we've demonstrated efficacy for the COVID component. We expect to demonstrate flu efficacy soon, which may be required for approval.

Q: Why isn't the next-gen COVID product included in your 2025 revenue guidance? What does the FDA gain by putting the Norovirus program on hold? A: James Mock, CFO: We learned from 2024 not to include unapproved products in guidance. Stephen Hoge, President: The FDA's hold allows them to review our documents thoroughly. We've already communicated the GBS case to all relevant parties.

Q: What changes have caused the bump in expense guidance? Can you provide more color on the PA program? A: James Mock, CFO: There hasn't been a change in our expense estimates. The PA program has shown a significant decrease in metabolic decompensation events, which will be the pivotal endpoint for registration.

Q: How do you plan to manage inventory write-downs in a seasonal vaccine market? A: James Mock, CFO: We've reduced inventory levels significantly, which should improve future projections. We're working on better matching supply with demand and have terminated some manufacturing agreements to optimize capacity.

Q: Can you provide an update on the Vertex CF program? A: Stephen Hoge, President: The trial is in the multiple ascending dose phase, and we expect a readout this year. Vertex is the sponsor and will provide further updates.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.