Q4 2024 Earnings Summary
- Upcoming data readouts from late-stage programs, including the INT cancer vaccine in adjuvant melanoma and the Norovirus vaccine, could significantly boost Moderna's pipeline and diversify revenue streams. Stephen Hoge mentioned that the Phase III study for the INT cancer vaccine is fully enrolled, and data readout is possible in 2026. Additionally, the Norovirus vaccine trial is fully enrolled in the Northern Hemisphere, and efficacy results could be available depending on case accrual.
- Significant reduction in R&D expenses as respiratory trials wind down could improve profitability. James Mock stated that over 50% of trial spend is related to respiratory trials, which are expected to reduce over the coming years, providing flexibility to further cut R&D expenses beyond the planned reductions.
- Continued focus on cost efficiencies and cash cost reductions enhances financial discipline. The company plans to reduce cash costs from $6.3 billion in 2024 to $5.5 billion in 2025 and further to $5 billion in 2026, demonstrating commitment to improving operational efficiency.
- Clinical hold on Norovirus vaccine due to a case of Guillain-Barré Syndrome (GBS), raising safety concerns and potential delays in the program .
- Cytomegalovirus (CMV) vaccine did not meet early efficacy criteria; uncertainty remains around final analysis timing and outcome, potentially impacting future growth .
- Approval of the flu-COVID combination vaccine may require efficacy data from the flu vaccine trial, which could delay approval and impact sales expectations .
| Metric | YoY Change | Reason |
|---|---|---|
Total Revenue | -65% (from $2,811M in Q4 2023 to $966M in Q4 2024) | Total revenue declined sharply as COVID-19 vaccine sales dropped markedly; Q4 2023 benefitted from deferred high-volume pandemic orders that did not repeat in Q4 2024, leading to a 65% decline in revenue. |
U.S. Revenue | -69% (from $979M in Q4 2023 to $308M in Q4 2024) | U.S. revenue fell significantly due to reduced domestic demand and the transition from pandemic-driven sales to a normalized seasonal market, contrasted with the higher sales volume seen in Q4 2023. |
European Revenue | -49% (from $616M in Q4 2023 to $317M in Q4 2024) | European revenue dropped by 49% as the previous period’s figures were boosted by deferred orders, while Q4 2024 reflects a more typical seasonal pattern with lower COVID-19 vaccine uptake. |
Rest of World Rev | -97% (from $1,375M in Q4 2023 to $44M in Q4 2024) | Rest of World revenue plunged by 97% largely because the one-time boost from fulfilled deferred orders in Q4 2023 was absent in Q4 2024, compounded by a marked contraction in non-U.S./European markets. |
Operating Income | From a profit of $6M to a loss of $1,246M | Operating income swung dramatically as rising costs—including inventory adjustments, manufacturing and supply chain expenses—eroded the modest profit reported in Q4 2023, resulting in a loss of $1,246M in Q4 2024. |
Net Income | From $217M in Q4 2023 to a loss of $1,120M | Net income deteriorated sharply due to the combined effects of a steep revenue decline and elevated cost pressures, turning a $217M profit in Q4 2023 to a $1,120M loss in Q4 2024. |
Diluted EPS | From $0.56 in Q4 2023 to -$2.91 in Q4 2024 | Diluted EPS dropped significantly as the dramatic revenue decline and increased operating losses negatively affected per-share earnings, moving from a positive $0.56 to a loss of $2.91. |
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Research and Development (R&D) Expenses | FY 2025 | $4.6 billion to $4.7 billion | $4.1 billion | lowered |
Selling, General, and Administrative (SG&A) Expenses | FY 2025 | Approximately $1.2 billion | Approximately $1.1 billion | lowered |
Capital Expenditures (CapEx) | FY 2025 | Approximately $1.2 billion | Approximately $0.4 billion | lowered |
Taxes | FY 2025 | negligible | negligible | no change |
Cash and Investments | FY 2025 | Approximately $9 billion | Approximately $6 billion | lowered |
Total Revenue | FY 2025 | no prior guidance | $1.5 billion to $2.5 billion, with first‐half sales of approximately $0.2 billion | no prior guidance |
GAAP Expenses | FY 2025 | no prior guidance | $6.4 billion, including $0.9 billion of noncash charges (stock‐based compensation, depreciation, amortization) | no prior guidance |
Additional Expense Reduction in 2026 | FY 2025 | no prior guidance | $0.5 billion reduction | no prior guidance |
| Metric | Period | Guidance | Actual | Performance |
|---|---|---|---|---|
Net Product Sales (FY) | FY 2024 | $3.0 B – $3.5 B | $3.109 B (sum of Q1=167, Q2=184, Q3=1,820, Q4=938) | Met |
Net Product Sales (Q4) | Q4 2024 | $0.8 B – $1.3 B | $938 M | Met |
Cost of Sales (% of Sales) | FY 2024 | 40% – 45% | ~47% (COGS $1.464 B ÷ Product Sales $3.109 B) (COGS from Q1=96, Q2=115, Q3=514, Q4=739; Product Sales from Q1=167, etc.) | Missed |
R&D Expenses | FY 2024 | $4.6 B – $4.7 B | $4.543 B (Q1=1,063, Q2=1,221, Q3=1,137, Q4=1,122) | Beat |
SG&A Expenses | FY 2024 | ~$1.2 B | $1.174 B (Q1=274, Q2=268, Q3=281, Q4=351) | Met |
Capital Expenditures (CapEx) | FY 2024 | ~$1.2 B | $1.58 B (Q1=196, Q2=182, Q3=151, Q4=1,051) | Missed |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
INT cancer vaccine (adjuvant melanoma) | Q1–Q3 2024: Consistently highlighted positive Phase II data, strong T-cell response, and progress toward Phase III. Emphasis on accelerated approval criteria (manufacturing readiness, enrollment). | Q4 2024: Phase III fully enrolled, timing of data readout remains uncertain (possibly 2026), still a top priority for growth. | Recurring topic; remains a major focus with event-driven milestones |
Norovirus vaccine | Q1 2024: Positive clinical data presented, moving towards pivotal Phase III. Limited or no updates in Q2. Q3 2024: Phase III trial design (25,000 adults) and high unmet need emphasized. | Q4 2024: Enrollment over 20k; program on clinical hold (GBS case). Company still optimistic about sufficient cases for efficacy readout. | Recurring topic; evolving sentiment due to safety hold but high potential impact |
Cytomegalovirus (CMV) vaccine | Q1–Q3 2024: Phase III fully enrolled; interim analysis planned by end of 2024; final results could follow soon depending on case accrual. | Q4 2024: Early efficacy criteria not met at interim. Study continues to final analysis; results expected in 2025. | Recurring topic; remains a priority despite interim miss |
RSV vaccine | Q1–Q2 2024: Awaiting approvals; strong efficacy data in older adults. Anticipated ACIP recommendation in U.S.. Q3 2024: Launched, but sales below expectations; planning full season contracting in 2025. | Q4 2024: U.S. filing for high-risk adults (18–59). Limited year-end sales ($25M). Long-term optimism. | Recurring topic; sentiment mixed (low sales vs. future expansion) |
Standalone flu vaccine | Q1–Q2 2024: Positive Phase III data, regulatory filings targeted for 2024. Q3 2024: Phase III efficacy study launched, potential early success after first season. | Q4 2024: Phase III case accrual on track; first efficacy readout expected end of current flu season. | Recurring topic; remains on track for pivotal data |
Combination flu-COVID vaccine | Q1–Q2 2024: Positive Phase III results, aiming for regulatory submission. Q3 2024: Launch not expected until 2026 (timing/contracting challenges). | Q4 2024: In filing for 50+ population; awaiting standalone flu efficacy data before final approval. Regulatory path depends on mRNA-1010 trial outcome. | Recurring topic; sentiment cautious (approval hinges on flu data) |
Oncology pipeline expansion (Merck partnership) | Q1–Q3 2024: Multiple Phase II/III trials announced (NSCLC, melanoma, bladder, renal) leveraging INT in combo with KEYTRUDA. | Q4 2024: Late-stage oncology portfolio confirmed as part of 10 prioritized programs; melanoma Phase III fully enrolled. | Recurring; consistent emphasis on Merck collaboration |
Pulmonary disease programs (cystic fibrosis with Vertex) | Q2 2024: Partnership limited to CF; single ascending dose portion completed. No mention in Q1/Q3. | Q4 2024: Multiple ascending dose portion ongoing, readout expected in 2025. | Newer recurring topic; updates focus on trial progress |
COVID-19 vaccine demand, contracts, and market share | Q1–Q3 2024: Decline in sales volume vs. prior year, shifting to seasonal pattern. Contracts deferred or lower in EU; U.S. competition intense. | Q4 2024: Demand stabilizing but below 2023; termination of some manufacturing deals; wide guidance range acknowledges uncertainty. | Recurring topic; sentiment mixed (durable market vs. lower share) |
Cost-reduction efforts and R&D expense management | Q1–Q3 2024: Ongoing SG&A cuts, AI adoption, R&D prioritization. | Q4 2024: Achieved large cuts in operating expenses; further GAAP/cash cost reductions planned into 2025–2026. | Recurring focus; sentiment positive on efficiency gains |
Future revenue guidance and product launch timelines | Q1–Q3 2024: Cautious near-term outlook; bullish on pipeline with 10 product approvals targeted by 2027. | Q4 2024: 2025 guidance at $1.5B–$2.5B, excluding new approvals. Emphasis on 10 key approvals driving mid-term growth. | Recurring; sentiment guarded near term, bullish long term |
Litigation risk (lawsuit from GSK) | Q3 2024: Briefly acknowledged lawsuit, stance to defend vigorously. | Q4 2024: No mention. | Topic no longer mentioned |
EU COVID vaccine tender | Q1 2024: Company participating in tender (up to 36M doses/year). Pricing undisclosed. Q2 2024: Expected very low EU sales in 2024; possible diversification benefits in 2025–2026. | Q4 2024: No mention. | Topic faded; limited EU commitments |
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Norovirus Vaccine Hold
Q: Impact of clinical hold on Norovirus vaccine?
A: The FDA placed the Norovirus vaccine trial on clinical hold due to a case of Guillain-Barré syndrome (GBS). Moderna proactively paused activities and updated study documents to prioritize patient safety. They expect minimal impact on study conduct or timelines since the Northern Hemisphere portion is fully enrolled with over 20,000 participants. The FDA is reviewing materials, and Moderna will address any questions. -
CMV Vaccine Timeline
Q: Is CMV vaccine final readout still in first half '25?
A: Despite not meeting early efficacy criteria at the interim, Moderna continues to accrue cases and remains blinded. They expect the final CMV vaccine analysis potentially by mid-2025, depending on event accrual. It's possible to meet or exceed efficacy expectations at the final analysis. -
INT Cancer Vaccine Timing
Q: When will INT cancer vaccine data be available?
A: The INT cancer vaccine Phase III study is fully enrolled. Due to differences from Phase II, timing is uncertain, but 2026 seems possible. Moderna will update timing as event accrual progresses. -
R&D Spend Flexibility
Q: Can you reduce R&D spend further if needed?
A: Moderna sees room to reduce R&D spend beyond the $3.6–$3.7 billion projected for 2027. Over 50% of trial spend is related to respiratory trials, expected to roll off over this year and next, providing additional flexibility. -
COVID-Flu Combo Approval
Q: Why wait for flu efficacy data for combo approval?
A: While the COVID component has demonstrated efficacy, Moderna hasn't yet shown efficacy for the flu component. They expect flu efficacy data from an ongoing trial by the end of the current season. Approval of the combo vaccine may require this data, potentially impacting the approval timeline. -
Revenue Guidance Excludes New Products
Q: Why exclude new products from 2025 guidance?
A: Moderna has excluded any revenue from new product approvals in its 2025 guidance, including the next-gen COVID vaccine and expanded RSV indications, to avoid uncertainty from unapproved products. -
Inventory Write-downs
Q: How are you reducing inventory write-downs?
A: Moderna had $500 million in inventory write-downs and $100 million in unutilized manufacturing capacity in 2024. They have reduced inventory levels to under $300 million and are actively aligning production with demand forecasts to minimize future write-downs. -
RSV Vaccine Recommendation
Q: Do you expect broader RSV vaccine recommendations?
A: Moderna is working with public health officials and expects the benefit-risk profile of their RSV vaccine to support expansion of recommendations to high-risk populations, including those aged 18–59. -
Next-Gen COVID Vaccine Guidance
Q: Is next-gen COVID vaccine included in guidance?
A: Moderna has not included revenue from the next-gen COVID vaccine in its 2025 guidance despite the upcoming PDUFA date, aiming to avoid including unapproved products in guidance. There is no indication of uncertainty regarding approval. -
Vertex CF Program
Q: Update on Vertex cystic fibrosis program?
A: In partnership with Vertex, Moderna has completed the single ascending dose trial and is now in the multiple ascending dose phase for cystic fibrosis patients. A readout from this trial is expected this year. -
Expense Guidance Clarification
Q: What caused the bump in expense guidance?
A: Moderna has not changed any expense estimates. Any perceived increase may be due to confusion between GAAP costs and cash costs, with no actual change in guidance figures. -
Regulatory Relationships
Q: Have you talked to the Trump administration?
A: Moderna worked productively with the Trump administration during the pandemic and looks forward to engaging with the new team as they get confirmed, emphasizing the importance of vaccines in public health.
Research analysts covering Moderna.