Moderna Inc (MRNA.US) 2025年第三季度业绩电话会

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会议摘要

Moderna reports significant cost reductions, with a 50% cut in cash costs over recent years, driven by completed phase 3 trials. Revenue from COVID-19 vaccines in the US has been adjusted downward due to lower vaccination rates, but the company remains optimistic about its robust pipeline, including 9-10 late-stage programs. Progress in oncology and rare disease areas, alongside strategic partnerships and manufacturing site expansions, are key to Moderna's strategy for achieving cash breakeven by 2028. The company has also seen a 34% reduction in cost of sales, with $1 billion in revenue from vaccine sales and $6.6 billion in cash and investments. Moderna anticipates 2025 revenue between $1.6 billion and $2 billion, reflecting better visibility into seasonal sales, and continues to advance its flu vaccine program and oncology pipeline while discontinuing the CMV vaccine development.

会议速览

Moderna's Q3 2025 Financials and Strategic Progress

Moderna reported Q3 2025 revenues of $1 billion from vaccine sales, a $200 million net loss, and $6.6 billion in cash. Highlighting 34% cost reduction, the company outlined strategic priorities, commercial progress, and clinical programs, emphasizing financial discipline and future value drivers.

Prioritizing Vaccine Distribution, Pipeline Advancement, and Financial Discipline for Enhanced Health Solutions

The dialogue focuses on driving the use of commercial vaccines, advancing the product pipeline, and maintaining financial discipline. Key achievements include approvals for seasonal and COVID vaccines in multiple countries, strategic partnerships, and significant cost savings. The discussion also highlights the discontinuation of the CMV vaccine program and the ongoing review of the flu post-COVID combination program by regulatory agencies.

2025 Q3 Financials: Revenue Overview and Q4 Outlook

The company reported Q3 2025 revenues of $1 billion, with $800 million from the US market, primarily driven by COVID vaccine sales including the launch of mnX-Bite. International revenue was $200 million, with significant contributions from Canada. For Q4, US revenue is forecasted between $100 million and $400 million, while international sales are expected to range from $300 million to $400 million, reflecting a year-over-year decline of 15% to 33% excluding one-time items.

Significant Financial Decline Amid Efficiency Gains and Cost Reductions

The dialogue covers a substantial year-over-year revenue decline due to reduced COVID-19 vaccine demand, highlighting cost of sales and R&D expense reductions. It emphasizes progress towards exceeding 2025 cost reduction targets, with a revised GAAP operating expense guidance lowered by $700 million, reflecting $500 million in cash cost and $200 million in non-cash reductions. The company aims to cut cash costs by 50% from 2023 to 2025, showcasing its commitment to efficiency and financial discipline.

Moderna's Financial Update: Narrowed 2025 Revenue Range, Lowered Cash Cost Estimate

Moderna has made strong financial progress, narrowing its 2025 revenue guidance to $1.6 to $2 billion, lowering the cash cost estimate by $900 million to $4.6 billion, and increasing year-end cash guidance to $6.5 to $7 billion. The company continues to target cash breakeven in 2028, with updated RD and Sgna expenses for 2025, and expects negligible taxes and approximately $300 million in capital expenditures.

Update on US Covid Vaccination Market, Pipeline Progress, and Oncology Advancements

Review of US Covid vaccination market, highlighting 42% retail market share with 55% volume from Next Spike. Pipeline includes approved products, phase 3 programs, and clinical candidates. Respiratory portfolio updates: approved vaccines, regulatory submissions, and phase 3 trials. Oncology progress: intis Marin studies, neoantigen data, and new trials for cancer therapies. Non-respiratory advancements in rare diseases and oncology.

Modernizing Healthcare: Strategic Growth, Financial Discipline, and Future Milestones

The company highlights market share gains, strategic partnerships, and pipeline advancements, including vaccine approvals and clinical milestones. Strong financial discipline and cost structure improvements are emphasized, aiming for a higher cash balance and transitioning to a diversified portfolio of commercial products, vaccines, and rare disease medicines.

Strategies for Cost Efficiency and Patent Defense in Upcoming Vaccine and Oncology Trials

A company discusses its strategy for cost reduction, emphasizing efficiency in clinical trials and prioritization of late-stage programs. They also express confidence in defending their proprietary technology against patent challenges, particularly in the US, with a significant trial scheduled for 2026.

Analysis of US Covid Vaccine Sales and CMV Vaccine Trial Results

The dialogue discusses the impact of reduced vaccination rates on US Covid vaccine sales, with a forecasted decrease of 20% to 40% in revenue for the year. It also covers the findings from a CMV vaccine trial, indicating that pentavalent neutralizing antibodies were insufficient to prevent CMV infection, highlighting the challenges in vaccine development for herpes viruses.

Norovirus Vaccine Study: Anticipating Two Seasons for Case Accrual

Discussing the norovirus vaccine program, the company explains the anticipation of a two-season study due to low case accruals, reflecting on the commercial opportunity and potential demand for the product. They express hope in accruing enough cases during the second season to demonstrate vaccine efficacy.

Commitment to Financial Goals Amidst Product Pipeline and Partnership Discussions

The dialogue underscores the company's dedication to achieving financial equilibrium by 2028 through a balanced strategy of cost reduction and revenue growth. It highlights confidence in the target product profile for a norovirus vaccine, emphasizes the importance of geographic expansion and strategic partnerships, and discusses ongoing negotiations with pharmaceutical companies and financial sponsors for product commercialization.

Covid Vaccines Evolution: MN Spike's Rise and Spike X's Role

The discussion focuses on the growing dominance of MN Spike vaccine, attributed to its clinical data and market momentum, particularly among high-risk populations. Meanwhile, Spike X retains its niche for pediatric use and specific high-risk conditions. Future strategies aim to expand MN Spike's global presence, with both vaccines expected to coexist based on healthcare providers' discretion.

Covid Vaccine Demand, Manufacturing Contributions, and Strategic Partnership Revenue Outlook

Discussion on the projected decline in U.S. Covid vaccine demand, with revised revenue guidance of $1 to $1.3 billion, attributing confidence to contracted and delivered orders. Outlines strategic partnerships' impact, shifting UK revenue to 2026, with Canada and Australia expected to contribute in Q4 and Q1 respectively, signaling potential growth.

Optimizing RD Investments for Cash Breakeven and Evaluating Rare Disease Platform Capacity

The discussion focuses on adjusting R&D spending to align with cash breakeven goals, deferring large Phase II investments in infectious diseases until profitability is achieved. It also explores the potential of the rare disease platform for rapid proof of concept, contrasting it with oncology programs, while emphasizing strategic investments with attractive ROI within breakeven targets.

Balancing Rare Disease, Oncology, and Infectious Disease Investment Strategies

Discusses strategic prioritization in moving forward with PA and MMA programs in rare diseases, pending registrational studies and breakeven targets, while considering oncology and infectious disease investments.

Forward-looking R&D Efficiency: No Program Stops Required for Further Cost Reductions

Discussion highlights anticipated R&D cost reductions through existing investment sunset, no need for halting programs, and continued early-stage investments in less capital-intensive areas.

CMV Trial Impact on Latent Virus Vaccines and Future Opportunities

The CMV trial's unique focus on preventing infection contrasts with other vaccine studies targeting disease prevention. Despite the setback, there remains potential for mRNA 1647 in managing CMV reactivation during bone marrow transplants. The company reassures that the CMV trial's outcomes do not negatively impact other latent virus vaccine programs, which are designed to prevent diseases rather than infections.

要点回答

Q：What was the main focus of the Moderna third quarter 2025 conference call?

A：The Moderna third quarter 2025 conference call focused on discussing Moderna's financial results for the said quarter, with CEO Stefan Biondini, President Stephen Hoge, and CFO Jamie Modisett making presentations. They reviewed financial performance, outlook, commercial progress, clinical programs, and key value drivers.

Q：What were the key financial results for Moderna in the third quarter?

A：In the third quarter, Moderna's revenue was $1 billion, driven by sales of their COVID-19 vaccines. The net loss for the quarter was $200 million, and they ended the quarter with $6.6 billion in cash and investments. Cost reduction efforts led to a 34% reduction in cost of sales.

Q：What were some of the strategic priorities that Moderna addressed in the third quarter?

A：Modern addressed several strategic priorities including the use of their commercial products, approvals of their vaccines in various countries, and establishment of manufacturing facilities and tech transfer agreements in countries like Canada, the UK, and Australia. They also announced positive Phase II efficacy data for their pipeline and continued progress on their Cancer Antigen Therapy ML program. A strategic partnership with Rick Countries, Canada, the UK, and Australia was also mentioned.

Q：What was the outcome of the clinical trial for Moderna's CME vaccine, and what decision did they make as a result?

A：The development of Moderna's CME vaccine did not meet its primary efficacy endpoint for CMV virus. As a result, Moderna decided to discontinue the development of the CME vaccine in that indication.

Q：How has Moderna's cost improvement program performed?

A：Moderna's cost improvement program has performed well, with the team diligently reducing costs. The company delivered a $2.1 billion reduction in cost of goods sold and related expenses from Q4 2024 to Q4 2025. The team is prioritizing their pipeline, driving productivity, and better pricing with suppliers.

Q：What is the updated full year 2025 revenue outlook for Moderna?

A：The updated full year 2025 revenue outlook for Moderna is a range of $1.6 to $2 billion, narrowed from the previous guidance of $1.4 to $1.8 billion. For the fourth quarter, the revenue outlook is $300 to $400 million for international markets, with total expected sales between 100 to $400 million.

Q：How did Moderna's cost of sales perform in the third quarter?

A：In the third quarter, Moderna's cost of sales was $207 million, representing 21% of net product sales. This was a 60% year-over-year decrease from $514 million in Q3 last year. The improvement was driven by lower inventory write-downs, reduced unutilized manufacturing capacity, and lower volume overall.

Q：What is the nature of the income tax provision for the quarter and why is there a global valuation allowance?

A：The income tax provision for the quarter was immaterial. A global valuation allowance is maintained against the majority of deferred tax assets, which limits the ability to recognize tax benefits from losses.

Q：What was the net loss for the quarter and how does it compare to the previous year?

A：The net loss for the quarter was $200 million, compared to net income of $13 million in Q3 of the previous year. Loss per share was 51 cents compared to earnings per share of 3 cents last year.

Q：What is Moderna's updated forecast for GAAP operating expenses and why was it reduced?

A：Moderna's updated GAAP operating expense guidance is reduced by another $700 million from $6 billion to $5.3 billion at the midpoint, reflecting additional progress across the company in driving efficiency gains and continued investment prioritization.

Q：What is the revised range for cash costs in 2025 and how has it changed from previous estimates?

A：The revised cash cost range for 2025 is $4.6 billion to $5.3 billion, a reduction of $900 million from the previous estimate of $5.5 billion.

Q：What financial targets is Moderna planning to update and when?

A：Moderna plans to update its 2026 and 2027 financial targets at its upcoming Analyst day on November 20, with a continued target of cash breakeven in 2028.

Q：What is the updated 2025 financial framework for total revenue and how does it compare to previous guidance?

A：The updated financial framework for total revenue in 2025 is narrowed to $1.6 to $2 billion from previous guidance of $1.5 to $2.2 billion.

Q：How are tariffs expected to impact Moderna's business?

A：Newly introduced tariffs are not expected to have a material impact on Moderna's business, but they continue to monitor changes to global tariffs.

Q：What is the new year-end cash guidance for Moderna and what factors contributed to the increase?

A：The new year-end cash guidance for Moderna is $6.5 to $7 billion, an increase of $0.5 to $1 billion from prior guidance, due to the reduction in operating expenses for the year.

Q：What is Moderna's current commercial positioning in the U.S. and how is the Covid vaccine sales performing?

A：Covid vaccine sales still represent the vast majority of Moderna's revenues, and the U.S. is the largest market. As of October 24, 2022, cumulative retail vaccinations were 13.2 million, down approximately 30% year over year, well within the script to script decline assumed in the 2025 U.S. revenue outlook.

Q：What is Moderna's market share for Covid vaccinations and how has it changed?

A：Moderna's Covid vaccination market share is 42%, up two percentage points from last year. Next bike now makes up 55% of Moderna's Covid vaccination volume.

Q：What are the updates regarding the clinical trials and regulatory submissions for the flu vaccine candidate?

A：Multiple data sets from the nres via clinical program were presented at ID week for a flu vaccine candidate. Regulatory submissions for approval in the US, Canada, Australia, and Europe are expected to be completed by January 2026. A combination flu Covid vaccine candidate, Mrna 1083, is under review with the European Medicines Agency and a refile with Health Canada is expected by the end of 2025. Phase three-i immunogenicity sub-analysis for the flu Covid combination program was presented at the Swe conference.

Q：What is the current status of the phase three-i norovirus study and the CMV efficacy study?

A：The ongoing phase three-i norovirus study has not yet accrued sufficient cases for an interim analysis, leading to the decision to proceed with a second northern hemisphere season for enrollment. The phase Iii CMV efficacy study did not meet the primary endpoint for prevention of infection, leading to the discontinuation of development in congenital CMV. Mrna 1647 will continue to be evaluated in an ongoing Phase 2 trial for patients undergoing bone marrow transplantation.

Q：What progress is being made with the oncology portfolio, specifically with Intis Marin and Mrna 4359?

A：Significant progress is being made with the oncology portfolio, including several late-stage studies for Intis Marin, which is partnered with Merck. The Phase II trial in adjuvant melanoma is fully enrolled, and both the Phase 2 adjuvant renal cell carcinoma trial and several other trials are fully enrolled or in the process of accruing participants. Mrna 4359 is enrolling a phase 2 study in first-line metastatic melanoma and non small cell lung cancer based on encouraging phase 1b data.

Q：What are the upcoming milestones for the mRNA programs and the potential impacts on the business?

A：Upcoming milestones include potential approvals for a combination of flu plus Covid vaccine in Europe, full-year contribution from a strategic partnership in Canada, the UK, and Australia in 2026, and results from five-year follow-up data from a phase 2 study and efficacy data from phase 3 studies for the Inserra program. Additionally, there are expectations for data from ongoing phase I and phase II studies.

Q：What is the strategy on cost discipline and how is it impacting the company's financial position?

A：The company has maintained strong financial discipline, having ahead of its initial 2025 cash cost production by $900 million. Cost structure improvements and productivity drives are expected to continue, with OER projections ranging from 6.5 to 7 billion, an increase from prior guidance. These actions are viewed as a right strategy for transitioning from a single endemic product company to a large diversified portfolio in vaccines and medicines.

Q：Can Moderna discuss potential large deals with pharma that they are reportedly working on?

A：While Moderna did not provide specifics, they acknowledged working on potential large deals with pharma and mentioned discussions with companies and financial sponsors such as Blackstone. They stated that when they have something to communicate, they will make an announcement.

Q：What are the strategies Moderna is focusing on for cost reduction and revenue growth to meet its financial targets?

A：Moderna is focusing on cost reduction strategies such as managing off-exchange CapEx and ample opportunity for further cost reductions which will be detailed at their Analyst Day event. On the revenue side, strategies include geographic expansion, strategic partnerships, and new product introductions which will be outlined more fully at the same event.

Q：How does Moderna plan to allocate its Covid vaccines, and what feedback is being received from pharmacists and clinicians?

A：Moderna's Covid vaccine, Spike, is taking a slight majority of their Covid vaccinations over mRNA-1273. The company is pleased with the launch of Spike and has been monitoring its reception, including feedback from pharmacists and clinicians, which has been positive and indicates a preference for Spike due to its profile and clinical data. There is a recognition that both vaccines will continue to have their roles, especially considering their unique attributes like approval in pediatrics for Spike.

Q：What is Moderna's strategy for vaccine distribution outside the US, and how will this impact their financials?

A：Outside the US, Moderna plans to continue to build on the success of their leading product, mRNA-1273, by launching it in the next season globally. The company anticipates growth in the brand as part of their overall franchise. They expect the split between the two vaccines to be influenced by healthcare providers and customers based on patient appropriateness. The company has raised the lower end of their revenue guidance and feels confident in their range for the US and outside the US, attributing to contracted delivery timelines and vaccine rates impacting revenue. They also mentioned strategic partnerships with the UK, Canada, and Australia that will contribute to revenue growth starting in 2026.

Q：Has the pipeline evaluation process evolved to focus on ROI for RD investments?

A：The pipeline evaluation process has evolved to focus on cash and investment optimization rather than ROI maximization for RD investments. Cost reductions and prioritizing investments based on cash break-even targets have been communicated.

Q：Are there plans to continue making cash investments in oncology based on the guidance provided?

A：Yes, there are plans to continue making cash investments in oncology, as exemplified by the intis Marin program and 4359, which are believed to have a very attractive ROI and fit within the company's breakeven guidance for 2028.

Q：What is the current strategy for rare disease programs in relation to investment and breakeven targets?

A：The current strategy for rare disease programs is to focus on demonstrating effectiveness with the existing portfolio and to prioritize making further investments after programs like PA and MMA complete their registrational studies and achieve breakeven targets.

Q：Can further cost reductions be made in the RD plan without halting programs or changing the prioritized list of assets?

A：Further cost reductions are expected in the RD plan without the need for program stops. This is based on the sunsetting of existing prioritized investments and continuing investments in early-stage, less cash-intensive areas.

Q：Is the outcome of the CMV trial likely to have read-through effects on other latent vaccine studies or is it an isolated event?

A：The CMV trial is considered unique and is not expected to have read-through effects on other latent vaccine studies, as these studies are focused on preventing diseases rather than infections, with the exception of a potential impact on CMV reactivation in bone marrow transplant patients.

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