Q3 2024 Earnings Summary
- Moderna expects up to 10 product approvals over the next 3 years, including key vaccines like CMV and RSV, which they believe will drive sales growth.
- They are making progress on cost-saving initiatives, expecting to decrease annual R&D expenses by $1.1 billion by 2027, improving financial efficiency.
- Moderna plans to launch a combination flu-COVID vaccine in 2026, aiming to protect high-risk individuals and seeing significant potential in this market.
- Delays in Key Product Launches May Impact Revenue Growth: The company does not expect its combination flu COVID vaccine to launch in 2025, pushing potential revenue from this product to 2026 or later. They have not included any revenue from certain submissions in their 2025 guidance. ,
- Expected Decline in Rest of World Revenues in 2025: Moderna anticipates a decrease in ex-U.S. revenues in 2025 before growth resumes in 2026, potentially leading to an overall revenue decline next year. ,
- Legal Risks Due to Ongoing Litigation: The company is facing a lawsuit from GSK over COVID-19 vaccine patents, which could have financial implications if not resolved favorably.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Net Product Sales | FY 2024 | $3.0B to $3.5B | $3.0B to $3.5B | no change |
Cost of Sales | FY 2024 | 40% to 50% | 40% to 45% | lowered |
R&D Expenses | FY 2024 | $4.5B | $4.6B to $4.7B | raised |
SG&A Expenses | FY 2024 | $1.3B | $1.2B | lowered |
Capital Expenditures | FY 2024 | $0.9B | $1.2B | raised |
Taxes | FY 2024 | negligible | negligible | no change |
Cash and Investments | FY 2024 | $9B | $9B | no change |
Implied Q4 Product Sales | FY 2024 | no prior guidance | $0.8B to $1.3B | no prior guidance |
U.S. Q4 Product Sales | FY 2024 | no prior guidance | $200M to $500M | no prior guidance |
International Q4 Product Sales | FY 2024 | no prior guidance | $600M to $800M | no prior guidance |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
COVID-19 vaccine market performance and competition | Previously highlighted declining year-over-year sales, more competitive U.S. contracting, seasonal market realities, and pricing pressure (Q2, Q1, Q4 2023). | Reported Q3 2024 U.S. COVID-19 vaccine sales of $1.2B, 40% retail market share, losing some share to Pfizer, and noted flat to -10% YOY vaccination rates. Emphasized efforts to boost uptake with education and advertising. | Continues to be a primary focus each quarter; balance of share gains/losses shifts with Pfizer. |
RSV vaccine development, approvals, and market expansion | Discussed approvals in older populations, ACIP recommendation, fierce competition with earlier market entrants, and focus on prefilled syringe advantages (Q2, Q1, Q4 2023). | Provided positive Phase III safety/data for mRNA-1345, using priority review voucher, but late approval impacted 2024 sales. Aims for broader label (18-59 high-risk) and anticipates better 2025 participation. | Growing emphasis on label expansions and long-term outlook; near-term headwinds from timing and inventory overhang. |
Flu-COVID combination vaccine timeline and potential revenue impact | Discussed Phase III trial success and ongoing regulatory planning; limited details on near-term revenue (Q2, Q1, Q4 2023). | Plans to file in 2024 but not using a priority review voucher, expecting a 2026 launch; no revenue included for 2025. | Confidence in combination’s long-term potential but delayed commercialization. |
Personalized cancer vaccine (INT) progress, manufacturing, and regulatory path | Previously noted enrollment in multiple Phase III trials (adjuvant melanoma, NSCLC), possibility of accelerated approval, and Marlborough facility readiness (Q2, Q1, Q4 2023). | Accelerating development with a new Phase III in NSCLC, facility completion on track by end of 2024, bridging work likely for FDA. | Continues strong progress; manufacturing readiness remains key for possible accelerated approvals. |
Cytomegalovirus (CMV) vaccine Phase III trial and pipeline potential | Trials are fully enrolled, with interim/final analyses likely in 2024; seen as a significant commercial opportunity (Q2, Q1, Q4 2023). | Expects to reach 81-event interim analysis by year-end 2024, viewing CMV as part of 10 potential approvals in next 3 years. | Steady progress on timeline; remains a key non-respiratory growth driver. |
Patent litigation and legal/regulatory risks | Sporadically mentioned; previously expressed confidence in IP defenses for COVID-19 tech (Q1 2024) or no mention in some quarters. | Addressed a new GSK lawsuit; stated they will defend vigorously, with no specifics on outcomes. | Still top-of-mind but not a central earnings call theme; limited detail provided. |
Financial guidance, revenue outlook, and cash management | Prior quarters noted similar drivers but with varying COVID-19 sales forecasts, cost-cutting, and stable cash targets (Q2, Q1, Q4 2023). | Reaffirmed FY2024 product sales of $3B–$3.5B; narrowed cost of sales to 40%-45%; expects R&D $4.6B-$4.7B, SG&A $1.2B, and $9B in year-end cash. | Sustained cost discipline and broadening pipeline underlie stable guidance; continues near-term revenue pressure. |
Manufacturing capacity expansions and facility readiness | Previously discussed resizing from pandemic demand, building specialized INT manufacturing, and global expansion plans (Q2, Q1, Q4 2023). | Massachusetts plant on track for completion by late 2024; new facilities in U.K., Canada, and Australia targeted for 2025; acquiring Norwood campus. | Ongoing expansion to support pipeline; consistent progress updates each quarter. |
Regulatory timelines, PDUFA dates, and accelerated approvals | Previously noted RSV PDUFA in May 2024, potential accelerated approval for INT, pending facility and trial enrollment (Q2, Q1, Q4 2023). | Plans 2024 submissions for next-gen COVID and RSV (using priority review vouchers), combination vaccine filing also 2024 but no priority review used. | Continues to inform investors on pacing; more clarity as multiple filings converge in 2024. |
-
COVID Vaccine Sales Outlook
Q: Why is Q4 COVID vaccine revenue declining significantly?
A: The company anticipates a 60% to 80% decline in Q4 COVID vaccine sales compared to Q3 due to earlier vaccinations and shifting dynamics across retail, IDN, and government channels. They observed an early start to the season with vaccinations peaking and now declining. Efforts are underway to boost vaccinations ahead of Thanksgiving and Christmas, but the overall impact remains uncertain. -
RSV Vaccine Market Potential
Q: What is the outlook for the RSV vaccine market?
A: The RSV vaccine market has been much lower than anticipated, impacted by new CDC guidelines released in June. The company expects a potential uptick in Q1 as inventory levels adjust and believes contracting in a full season next year will improve their position. They remain confident in the long-term importance of RSV vaccines, particularly outside the U.S., where approvals are progressing. -
Flu-COVID Combo Vaccine Approval Timing
Q: When will the flu-COVID combo vaccine be available?
A: Due to timing considerations, the company will not use a priority review voucher for the flu-COVID combo vaccine, as it would not align with the contracting season. They plan to submit for approval this year but do not expect the product to impact the 2025 flu season. They anticipate potential approval and market impact in 2026, aiming to protect high-risk populations with a combination vaccine. -
Individualized Neoantigen Therapy (INT) Progress
Q: What is the status of the INT program and manufacturing facility?
A: The INT program is accelerating with a new Phase III trial in non-small cell lung cancer. The manufacturing facility in Massachusetts is on track for completion by year-end, and once operational, clinical work will transition there. Bridging studies will be conducted, and manufacturing capacity is not a primary constraint for expanding the INT program into additional indications. -
Ex-U.S. Revenue and Contracts
Q: How significant are ex-U.S. COVID revenue contracts?
A: While specifics are undisclosed, the company has established contracts with countries like the UK, Canada, Australia, and Brazil. Ex-U.S. revenues are expected to decline in 2025 but then uptick in 2026 as new products are added and minimum purchase commitments grow over time. -
Cytomegalovirus (CMV) Vaccine Trial Updates
Q: When can we expect CMV vaccine trial results?
A: The CMV vaccine trial is progressing steadily with case accrual. If the Data Safety Monitoring Board (DSMB) recommends unblinding at the interim analysis due to meeting efficacy criteria, results will be shared promptly. Otherwise, the final analysis could happen quickly, and communication will depend on the timing and conditions. -
Legal Liabilities and Litigation
Q: What's the company's stance on the GSK lawsuit?
A: The company will not comment on the merits of GSK's case but notes that such lawsuits are not uncommon during market formation around new technology. They are prepared to defend themselves and look forward to presenting their case at trial as scheduled. -
Orphan Disease Pipeline Developments
Q: What's the path forward for the orphan disease programs?
A: Pivotal trials for MMA and PA are moving forward, with plans to use a biomarker for approval in MMA, potentially accelerating timelines. The goal is to launch these products in the 2026+ timeframe, with the possibility of earlier approval if patient accrual is rapid. -
Financial Impacts: Reserve Returns
Q: What are the details on reserve returns from last season?
A: The company released about $140 million in the quarter by reducing reserves, lowering the prior estimate from over $500 million to approximately $400 million. They are applying learnings to forecast the anticipated product returns reserve for this season and will monitor vaccination rates to adjust projections. -
Impact of Election Results on Vaccine Use
Q: Will the change in administration affect vaccine use in the U.S.?
A: The company believes their mission aligns with public health goals and will continue to collaborate with government leaders regardless of administrative changes. They aim to reassure confidence and focus on delivering innovative medicines to improve health outcomes.
Research analysts covering Moderna.