莫德納 (MRNA) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the Moderna first-quarter 2025 conference call. (Operator Instructions) Please be advised, today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Moderna 2025 年第一季電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker today, Lavina Talukdar, Head of Investor Relations at Moderna. Please go ahead.

現在，我想將會議交給今天的發言人，Moderna 投資者關係主管 Lavina Talukdar。請繼續。

Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's first-quarter 2025 financial results and business updates. You can access the press release issued this morning as well as the slides that we will be reviewing by going to the Investors section of our website. On today's call are Stephane Bancel, our Chief Executive Officer; Stephen Hoge, our President; and Jamey Mock, our Chief Financial Officer.

謝謝你，凱文。大家早安，感謝您參加今天的電話會議，討論 Moderna 2025 年第一季的財務業績和業務更新。您可以造訪我們網站的「投資者」部分，查看今天早上發布的新聞稿以及我們將要審查的幻燈片。參加今天電話會議的有我們的執行長 Stephane Bancel；我們的總裁 Stephen Hoge；以及我們的財務長 Jamey Mock。

Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.

在我們開始之前，請注意，本次電話會議將包括根據 1995 年《私人證券訴訟改革法》的安全港條款所作的前瞻性陳述。請參閱隨附簡報的第 2 張投影片和我們向美國證券交易委員會 (SEC) 提交的文件，以了解可能導致我們的實際業績和結果與這些前瞻性陳述中明示或暗示的業績和結果存在重大差異的重要風險因素。

With that, I will now turn the call over to Stephane.

說完這些，我現在將電話轉給史蒂芬。

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of our business in Q1. Jimmy will present our financial results and our outlook. Stephen will review our clinical programs, and I will come back to some key priorities and catalysts before we take your questions.

謝謝你，拉維娜。大家早安或下午好。感謝您今天加入我們。我將首先回顧我們第一季的業務。吉米將介紹我們的財務表現和展望。史蒂芬將審查我們的臨床項目，在回答您的問題之前，我將回顧一些關鍵的優先事項和催化劑。

Let me start with a review of our financials. Our Q1 revenues were $0.1 billion, had a loss of $1 billion. These were in line with our expectations and reflect the highly seasonal nature of our respiratory vaccine business. We ended the quarter with $8.4 billion in cash and investments.

首先讓我回顧一下我們的財務狀況。我們第一季的營收為 1 億美元，虧損 10 億美元。這些符合我們的預期，並反映了我們的呼吸道疫苗業務的高度季節性。本季結束時，我們的現金和投資為 84 億美元。

As you are aware, we are focused on financial discipline. I'm pleased to announce that continued cost reduction efforts in the first quarter of 2025 led to a 19% reduction of cost of sales, R&D, SG&A combined compared to the first quarter of 2024. I would like to thank our team for the great work.

如您所知，我們非常注重財務紀律。我很高興地宣布，透過持續降低成本，2025 年第一季的銷售成本、研發成本、銷售、一般及行政費用合計與 2024 年第一季相比降低了 19%。我要感謝我們團隊的出色工作。

During the quarter, we made solid progress against our three priorities: priority number one, expanded markets for commercial products. Earlier this year, we were awarded a tender opportunity, allowing us to complete for COVID vaccine business in Europe. Additionally, during the quarter, mRESVIA received approvals in Australia, in Taiwan and in the UK and most recently, in Switzerland. This is in addition to a program we received in 2024 in the US, EU, and Canada.

本季度，我們在三大優先事項上取得了紮實進展：第一，擴大商業產品市場。今年早些時候，我們獲得了一個投標機會，使我們能夠完成歐洲的 COVID 疫苗業務。此外，本季度，mRESVIA 獲得了澳洲、台灣、英國的批准，最近又獲得了瑞士的批准。這是我們 2024 年在美國、歐盟和加拿大實施的計畫的補充。

Our second priority has a single pipeline to drive sales growth and diversification. I am excited to announce the expansion of our oncology portfolio with Checkpoint medicine, which Stephen will review later. For Phase 3 flu program, we have exceeded the required number of case accruals to run an interim vaccine efficacy analysis. We also projected encouraging data from our key programs, including RSV, CMV, and IAC at reset medical conferences.

我們的第二個優先事項是建立單一管道來推動銷售成長和多樣化。我很高興地宣布，我們將與 Checkpoint 醫學公司合作擴大我們的腫瘤學產品組合，Stephen 稍後將對此進行回顧。對於第三階段流感計劃，我們已經超過了進行中期疫苗效力分析所需的病例累積數量。我們也在重置醫學會議上預測了包括 RSV、CMV 和 IAC 在內的主要項目的令人鼓舞的數據。

We are pleased to share that IC will now be known by the high end of international nonproprietary name of intismeran autogene. This is in addition reflects the growing maturity of our product development program and make an important milestone as we continue adapting towards potential regulatory approvals.

我們很高興地告訴大家，IC 現在將以國際非專利名稱 intismeran autogene 的高端名稱而聞名。這進一步反映了我們的產品開發計劃日益成熟，並在我們繼續適應潛在的監管批准的過程中成為一個重要的里程碑。

And finally, on our third priority, executing with financial discipline. The first quarter of 2025 marks the third consecutive quarter we will reduce combined R&D and SG&A expenses by double digits year-over-year.

最後，我們的第三個優先事項是執行財務紀律。2025 年第一季是我們連續第三個季度將研發和銷售、一般及行政費用總額比去年同期減少兩位數。

With that, let me turn to Jamey.

接下來，讓我來談談 Jamey。

Thanks, Stephane, and welcome, everyone. Today, I'll cover our first-quarter financial results, our full-year outlook, and an updated operating cost framework as we look ahead to 2026 and 2027. Let's start with our first quarter financial results shown on slide 7.

謝謝，史蒂芬，歡迎大家。今天，我將介紹我們的第一季財務業績、全年展望以及展望 2026 年和 2027 年的最新營運成本框架。讓我們從投影片 7 上顯示的第一季財務表現開始。

Net product sales were $86 million, driven primarily by COVID vaccine sales. The US accounted for about one-third of total sales with the remainder from international markets. This result was in line with expectations given the seasonal nature of respiratory vaccines with most sales anticipated in the second half of the year.

淨產品銷售額為 8,600 萬美元，主要受 COVID 疫苗銷售推動。美國約佔總銷售額的三分之一，其餘則來自國際市場。鑑於呼吸道疫苗的季節性，預計大部分銷售將在下半年完成，這一結果符合預期。

We observed lower vaccination rates compared to Q1 last year, reflecting the continued transition of COVID into routine seasonal vaccination patterns. In addition to product sales, we recorded $22 million of other revenue, bringing total revenue for the quarter to $108 million, a decrease of 35% year-over-year, but in line with expectations. Cost of sales for the quarter was $90 million compared to the first quarter of 2024, cost of sales decreased $6 million, primarily due to lower sales volume.

我們觀察到疫苗接種率與去年第一季相比有所下降，這反映出 COVID 正在持續轉變為常規季節性疫苗接種模式。除產品銷售外，我們還錄得2,200萬美元的其他收入，使本季總收入達到1.08億美元，年減35%，但符合預期。本季銷售成本為 9,000 萬美元，與 2024 年第一季相比，銷售成本減少了 600 萬美元，主要原因是銷售量下降。

While total sales declined year-over-year, it represented 104% of net product sales this quarter, up from 58% in the prior year, driven by lower volume and revenue mix. R&D expenses were $856 million, a 19% decrease year-over-year. The decline was mainly driven by lower clinical development spend across our respiratory programs reflecting the timing of trial activity and the wind down of certain studies.

雖然總銷售額年減，但由於銷售量和收入結構下降，本季其佔淨產品銷售額的 104%，高於去年同期的 58%。研發費用為8.56億美元，年減19%。下降的主要原因是我們呼吸計畫的臨床開發支出減少，反映了試驗活動的時間和某些研究的結束。

This was partially offset by continued investment in our norovirus program and oncology. SG&A expenses were $212 million, down 23% year-over-year. The decrease was driven by broad-based cost reductions. These reductions reflect our continued focus on streamlining operations and managing costs across the organization.

這部分被我們對諾羅病毒計畫和腫瘤學的持續投資所抵消。銷售、一般及行政費用為 2.12 億美元，較去年同期下降 23%。成本下降的原因是大範圍的成本削減。這些削減反映了我們對精簡整個組織營運和管理成本的持續關注。

We recognized an income tax provision of $7 million in the first quarter. Similar to the prior year, the provision was not material due to the continued valuation allowance on our global deferred tax assets. which limits our ability to recognize tax benefits from the loss. Net loss for the quarter was $1 billion, a $204 million improvement compared to a $1.2 billion loss in the first quarter of 2024. Loss per share was $2.52, an improvement from a loss of $3.07 in the prior year period.

我們在第一季確認了 700 萬美元的所得稅準備金。與前一年類似，由於我們繼續對全球遞延稅項資產進行估值準備，因此該準備金並不重大。這限制了我們從損失中確認稅收優惠的能力。本季淨虧損為 10 億美元，與 2024 年第一季的 12 億美元虧損相比改善了 2.04 億美元。每股虧損為 2.52 美元，較去年同期的 3.07 美元虧損有所改善。

We ended the quarter with cash, cash equivalents and investments totaling $8.4 billion. compared to $9.5 billion at the end of Q4. The decrease was primarily driven by the operating loss for the quarter.

本季結束時，我們的現金、現金等價物和投資總額為 84 億美元。而第四季末則為 95 億美元。下降的主要原因是本季的經營虧損。

Now let's turn to our financial framework for 2025 on slide 8. Our expectations for the full year 2025 remain unchanged from our initial guidance in February. We still expect total revenue in 2025 to be in the range of $1.5 billion to $2.5 billion with first half sales of approximately $0.2 billion, reflecting the seasonality of our respiratory vaccine business.

現在讓我們來看看第 8 張投影片上的 2025 年財務架構。我們對 2025 年全年的預期與 2 月的初步指引保持不變。我們仍然預計 2025 年的總收入將在 15 億美元至 25 億美元之間，上半年的銷售額約為 2 億美元，這反映了我們呼吸道疫苗業務的季節性。

As a reminder, the wide range of our guidance reflects the uncertainties in vaccination rates, the competitive market environment, the size of the RSV market, and timing of licensure of our factories and product approvals in Australia, Canada, and the UK

需要提醒的是，我們的指導範圍廣泛，反映了疫苗接種率、競爭激烈的市場環境、呼吸道合胞病毒市場規模以及我們在澳洲、加拿大和英國的工廠許可和產品批准時間的不確定性

As previously shared, while we filed three products with the FDA in 2024, since we don't know the timing of potential approvals, we are not including any new product revenue in our guidance range. Cost of sales is projected to be approximately $1.2 billion, reflecting continued improvements in manufacturing efficiency, and lower expected inventory write-offs, offset by increased costs associated with the go-live of our new manufacturing sites in Australia, Canada, and the UK

正如之前所分享的，雖然我們在 2024 年向 FDA 提交了三種產品，但由於我們不知道潛在批准的時間，因此我們沒有將任何新產品收入納入我們的指導範圍。預計銷售成本約為 12 億美元，反映了製造效率的持續提高和預期庫存註銷的降低，但被我們在澳洲、加拿大和英國的新製造基地投入使用相關的成本增加所抵消

I'll now provide some perspective on the newly introduced global tariffs, those in action as of today have not had a significant direct impact on Moderna. All of our drug substance for the US market is manufactured at our facilities in Massachusetts. Our commercial drug substance has been shipped overseas for fill/finish operations before shipment to the final customers.

現在，我將對新推出的全球關稅提供一些看法，截至今天實施的關稅尚未對 Moderna 產生重大直接影響。我們面向美國市場的所有藥品均在馬薩諸塞州的工廠生產。我們的商業藥物成分已運往海外進行灌裝/完成操作，然後運送給最終客戶。

Internationally, our new plants in Australia, Canada and the UK are expected to be outlined in 2025 to supply local markets. Finally, material sourced from China are not material to our total cost base. R&D expenses are anticipated to be approximately $4.1 billion as we continue to invest in our late-stage pipeline while maintaining financial discipline. SG&A expenses are expected to be approximately $1.1 billion, reflecting a continued focus on efficiency while supporting our commercial execution.

在國際上，我們預計將於 2025 年在澳洲、加拿大和英國建立新工廠，以供應當地市場。最後，來自中國的材料對我們的總成本基礎來說並不重要。由於我們將繼續投資後期研發管線，同時保持財務紀律，預計研發費用約為 41 億美元。銷售、一般及行政費用預計約為 11 億美元，反映出我們在支持商業執行的同時持續關注效率。

While we are pleased with the cost reductions that we achieved in both R&D and SG&A during the first quarter of 2025, it is still early in the year, and we are not updating our full year expense guidance at this time.

雖然我們對 2025 年第一季在研發和銷售、一般及行政費用方面實現的成本削減感到滿意，但現在仍處於年初階段，我們目前不會更新全年費用指引。

That being said, it is a strong start to the year, and we are looking to accelerate additional cost reductions in 2025. We expect taxes to be negligible in 2025, and capital expenditures are projected to be approximately $400 million. And we still expect to end 2025 with approximately $6 billion in cash and investments.

話雖如此，今年的開局還是很強勁的，我們希望在 2025 年加速進一步降低成本。我們預計 2025 年的稅收將微不足道，資本支出預計約為 4 億美元。我們仍預計到 2025 年，現金和投資將達到約 60 億美元。

Beyond 2025, we are announcing today our plan to drive an additional $1.4 billion to $1.7 billion of cost reductions by 2027. As part of our commitment to achieve our 2028 breakeven target on a cash cost basis. To that end, we are reducing our 2026 GAAP operating expense forecast from $5.9 billion to a range of $5.4 billion to $5.7 billion. This guidance includes $0.9 billion of noncash charges from stock-based compensation, depreciation and amortization.

2025 年以後，我們今天宣布我們的計劃，到 2027 年再削減 14 億至 17 億美元的成本。作為我們承諾在現金成本基礎上實現 2028 年損益平衡目標的一部分。為此，我們將 2026 年 GAAP 營運費用預測從 59 億美元下調至 54 億美元至 57 億美元之間。該指引包括 9 億美元的股票薪酬、折舊和攤提非現金費用。

Excluding these items, we now project a 2026 cash cost of approximately $4.7 billion at the midpoint of the range. We are also planning to reduce 2027 GAAP expenses to between $4.7 billion and $5 billion. with a 2027 cash cost of approximately $4.2 billion at the midpoint of the range, excluding stock-based compensation, depreciation and amortization.

除去這些項目，我們現在預計 2026 年的現金成本約為 47 億美元，處於該範圍的中間值。我們還計劃將 2027 年 GAAP 支出削減至 47 億美元至 50 億美元之間。 2027 年現金成本約為 42 億美元（位於範圍中間值），不包括股票薪酬、折舊和攤提。

Stepping back from 2023 to 2027, we are planning a total reduction in annual GAAP expenses of over $6 billion, which represents a 55% reduction over four years from $11 billion annually in 2023 to $5 billion or less in 2027.

從 2023 年到 2027 年，我們計劃將年度 GAAP 費用總共減少 60 億美元以上，這意味著四年內將減少 55%，從 2023 年的每年 110 億美元減少到 2027 年的 50 億美元或更少。

The first $4 billion of GAAP expense reductions were realized in 2024 with the largest driver coming from reductions in our cost of sales, when we undertook a strategic initiative in the second half of 2023, to restructure our manufacturing footprint to better optimize pandemic level demand of our COVID vaccine. We also reduced SG&A by 24% from 2023 to 2024 through a variety of cost-out initiatives throughout the company, and R&D declined 6% year-over-year to $4.5 billion in 2024.

2024 年實現了首次 40 億美元的 GAAP 費用削減，其中最大的推動力來自於銷售成本的降低，當時我們在 2023 年下半年採取了一項戰略舉措，重組我們的製造足跡，以更好地優化我們的 COVID 疫苗大流行水平的需求。我們也透過全公司範圍內的各種成本削減舉措，將 2023 年至 2024 年的銷售、一般及行政費用 (SG&A) 降低了 24%，2024 年的研發費用年減 6% 至 45 億美元。

While we are continuing to drive additional cost reductions and efficiency gains in both cost of sales and SG&A, the largest future source of cost reductions will come from R&D. which currently represents nearly two-thirds of our expense base. This projected decline in R&D expense will come from the completion and wind down of our ongoing Phase 3 trials. procurement savings from contract renegotiations and other process efficiencies.

雖然我們將持續推動銷售成本和銷售、一般及行政費用的進一步降低和效率提升，但未來最大的成本降低來源將來自研發。目前這占我們支出基礎的近三分之二。預計研發費用的下降將源自於我們正在進行的第三階段試驗的完成和結束。透過合約重新談判和其他流程效率實現的採購節省。

In summary, we are encouraged by the progress we've made in our cost-out initiatives to date. As Stephan mentioned, we now have had three consecutive quarters of double-digit year-over-year declines in combined R&D and SG&A expenses. Our teams continue to identify and act on new savings opportunities, which gives us the confidence in meeting our new 2026 and 2027 cost targets.

總而言之，我們對迄今為止在成本削減計劃中取得的進展感到鼓舞。正如史蒂芬所提到的，我們的研發和銷售、一般及行政費用總額已連續三個季度出現兩位數的同比下降。我們的團隊不斷發現並利用新的節省機會，這使我們有信心實現新的 2026 年和 2027 年成本目標。

With that, I will now turn the call over to Stephen.

說完這些，我現在將電話轉給史蒂芬。

Thank you, Jamey. Good morning or good afternoon, everyone. Today I will review progress across our pipeline.

謝謝你，傑米。大家早安或下午好。今天我將回顧我們整個管道的進展。

Slide 11 is a review of our prioritized pipeline, which is introduced at our R&D Day last September. As you know, we have since filed for regulatory approvals for three of these programs. our next-generation COVID vaccine in mRNA-1283, our RSV vaccine for high-risk adults aged 18 to 59 mRNA-1345 and our flu plus COVID combination vaccine for individuals aged 50 and over are mRNA-1083.

幻燈片 11 是對我們的優先管道的回顧，它是在去年 9 月的研發日上推出的。如您所知，我們已為其中三個項目申請監管部門批准。我們的下一代 COVID 疫苗為 mRNA-1283，我們針對 18 至 59 歲高風險成人的 RSV 疫苗為 mRNA-1345，我們針對 50 歲及以上人群的流感加 COVID 聯合疫苗為 mRNA-1083。

As part of our ongoing portfolio optimization, we've made a strategic decision to deprioritize the flu covid combination vaccine for younger adults, those aged 18 to 49.

作為我們正在進行的投資組合優化的一部分，我們做出了一項策略決策，不再優先為年齡在 18 歲至 49 歲之間的年輕人提供流感新冠聯合疫苗。

While we remain committed to the long-term potential of combination respiratory vaccines, we are going to be focusing our efforts on combination vaccines in the older adult population for now. At the same time, we are excited to announce the advancement of our oncology pipeline with the addition of the Checkpoint program.

雖然我們仍然致力於聯合呼吸道疫苗的長期潛力，但目前我們將把精力集中在老年族群的聯合疫苗上。同時，我們很高興地宣布，隨著 Checkpoint 計劃的加入，我們的腫瘤學管道取得了進展。

The prioritization of this Phase 2 program is based on our early but encouraging data and is consistent with our strategy to build our therapeutics pipeline, particularly in oncology. We are targeting filings for Checkpoint and the other six programs on the right-hand side of this slide by 2028, subject to notes to data and regulatory consultations.

這個第 2 階段計畫的優先順序是基於我們早期但令人鼓舞的數據，並且與我們建立治療管道（特別是在腫瘤學領域）的策略一致。我們的目標是到 2028 年為 Checkpoint 和此投影片右側的其他六個項目提交申請，但須遵守數據說明和監管諮詢。

Moving to slide 13, which outlines the latest development in our late-stage respiratory portfolio. As I just mentioned, we submitted regulatory filings late last year for three programs. Our next-gen COVID vaccine has a PDUFA date of May 31. The age group expansion for our RSV vaccine has a PDUFA date of June 12, and we look forward to decisions on both products in the coming months.

前往第 13 張投影片，其中概述了我們後期呼吸產品組合的最新發展。正如我剛才提到的，我們在去年年底為三個項目提交了監管文件。我們的下一代 COVID 疫苗的 PDUFA 日期為 5 月 31 日。我們的 RSV 疫苗的年齡組擴展的 PDUFA 日期為 6 月 12 日，我們期待在未來幾個月內對這兩種產品做出決定。

For our flu COVID combination vaccine, we received a November 2025 PDUFA date. However, following feedback from the FDA during the review, the flu vaccine efficacy data will now be needed to support the application.

對於我們的流感 COVID 組合疫苗，我們收到的 PDUFA 日期是 2025 年 11 月。然而，根據 FDA 在審查過程中的回饋，現在需要流感疫苗功效數據來支持該申請。

As a result, we now expect to review timeline to be extended into 2026 and be dependent upon positive Phase 3 efficacy results from our ongoing food vaccine trial. and the addition of these data to the submission.

因此，我們現在預計審查時間表將延長至 2026 年，並取決於我們正在進行的食品疫苗試驗的第三階段積極療效結果。並將這些數據添加到提交中。

And on that point, our stand-alone flu vaccine candidate, mRNA-1010, is in its Phase 3 efficacy study. And due to the intensity of the current flu season, has now exceeded the required number of cases to support the interim efficacy analysis, which we expect to complete now by this summer.

在這一點上，我們的獨立流感疫苗候選藥物 mRNA-1010 正處於第 3 階段功效研究階段。由於目前流感季節的強度，目前的病例數已經超過了支持中期療效分析所需的病例數，我們預計該分析將在今年夏天完成。

Now turning to our nonrespiratory vaccine and rare disease portfolio. Our for our CMV vaccine, we recently presented durability data from our Phase 2 study at the SMID Conference, demonstrating that mRNA-1647 continues to elicit robust antibody responses for three years post vaccination, showing very strong durability.

現在談談我們的非呼吸道疫苗和罕見疾病產品組合。對於我們的 CMV 疫苗，我們最近在 SMID 會議上展示了我們第 2 階段研究的耐久性數據，表明 mRNA-1647 在接種疫苗後三年內持續引發強烈的抗體反應，表現出非常強烈的耐久性。

We also had the opportunity to share these findings along with an overview of our CMV program at the inaugural CMV vaccines Work Group as a part of the April ACIP meetings. We're encouraged by the establishment of this work group, which reflects the growing recognition of CMV as a significant public health concern and a commitment to reducing the disease burden of CMV.

作為 4 月 ACIP 會議的一部分，我們還有機會在首屆 CMV 疫苗工作小組上分享這些發現以及我們的 CMV 計劃概述。我們對該工作小組的成立感到鼓舞，這反映出人們日益認識到 CMV 是一個重大的公共衛生問題，並致力於減輕 CMV 疾病負擔。

Our Phase 3 CMV efficacy study for mRNA-1647 continues to recruit cases. We remain blinded to the study results at this time and expect the final efficacy analysis to come later this year. For norovirus, we are pleased to note that the FDA clinical hold for our Phase 3 trial was lifted during the quarter. The study is fully enrolled in the Northern Hemisphere, and we are continuing to enroll in the Southern Hemisphere.

我們針對 mRNA-1647 的 3 期 CMV 療效研究正在繼續招募病例。我們目前還不清楚研究結果，預計最終的療效分析將在今年稍後公佈。對於諾羅病毒，我們很高興地註意到，FDA 對我們第 3 階段試驗的臨床暫停已在本季度解除。這項研究已在北半球全面展開，我們正在繼續在南半球進行研究。

Phase 3 FC readout for norovirus is dependent upon case accruals. And given the uncertainty of that timing, the targeted approval could be in 2026 or 2027, depending upon that readout. We expect to have more clarity on the pace of case accrual and potential readout timing later this year.

諾羅病毒的 3 期 FC 讀數取決於病例的累積。鑑於時間的不確定性，目標批准時間可能是 2026 年或 2027 年，具體取決於結果。我們預計今年稍後將更清楚地了解案件累積速度和潛在的讀數時間。

In rare diseases, our probiotic acidemia, or PA program is currently in a registrational study. We've made good progress with regulators and with enrollment. Following review of program timeline and other aspects of the launch, we now anticipate a 2027 approval. Similarly, for methylmalonic acidemia or MMA, we've finalized the registrational study design with the FDA, and we plan to initiate that trial in 2025. We expect the potential for approval for M&A in 2028.

在罕見疾病中，我們的益生菌酸血症或 PA 計劃目前正在進行註冊研究。我們在監管機構和招生方面取得了良好進展。在審查了計劃時間表和啟動的其他方面之後，我們預計該專案將於 2027 年獲得批准。同樣，對於甲基丙二酸血症或 MMA，我們已經與 FDA 完成了註冊研究設計，並計劃於 2025 年啟動該試驗。我們預計 2028 年併購交易有可能獲得批准。

We continue to advance our oncology portfolio with significant progress across our individualized neoantigen therapy program, Intismeran, our Checkpoint program, and our early-stage oncology programs. In collaboration with Merck, we have several late-stage studies underway for Intismeran. As a reminder, the Phase 3 trial in adjuvant melanoma is now fully enrolled. We also have two Phase 3 studies in non-small cell lung cancer, both evaluating Intismeran in combination with KEYTRUDA in patients with and without prior new adjuvant treatment.

我們繼續推進我們的腫瘤學產品組合，在個人化新抗原治療計劃、Intismeran、我們的 Checkpoint 計劃和我們的早期腫瘤學計劃中取得了重大進展。我們與默克公司合作，對 Intismeran 進行了多項後期研究。提醒一下，輔助性黑色素瘤的 3 期試驗目前已全部招募完畢。我們也針對非小細胞肺癌進行了兩項 3 期研究，分別評估了 Intismeran 與 KEYTRUDA 聯合治療對接受過和未接受過新輔助治療的患者的效果。

Additionally, we're conducting randomized Phase 2 trials in adjuvant high-risk muscle invasive bladder cancer and adjuvant renal cell carcinoma. I'm happy to announce that the Phase 2 adjuvant renal cell carcinoma study is now also fully enrolled. We're also expanding the scope of our Intismeran program into earlier stages of disease, with the addition of a new Phase 2 study that moves beyond the adjuvant setting. This study evaluates Intismeran as monotherapy or in combination with BCG, the standard of care in high-risk non-muscle invasive bladder cancer and will help us explore Intismeran's potential in earlier disease settings beyond the adjuvant landscape.

此外，我們正在對輔助高風險肌肉層浸潤性膀胱癌和輔助性腎細胞癌進行隨機 2 期試驗。我很高興地宣布，第二階段輔助腎細胞癌研究現在也完全招募完畢。我們還將 Intismeran 計畫的範圍擴展到疾病的早期階段，並增加了一項超越輔助治療的新的第 2 階段研究。這項研究評估了 Intismeran 作為單一療法或與 BCG（高風險非肌肉層浸潤性膀胱癌的治療標準）聯合使用的效果，並將幫助我們探索 Intismeran 在輔助治療領域之外的早期疾病環境中的潛力。

As I mentioned a moment ago, we have prioritized advancement of our Checkpoint program based on encouraging early clinical results. The program is currently being evaluated in a Phase 2 study for both first-line metastatic melanoma and first-line metastatic non-small cell lung cancer. I'll review the details of that program on the next slide. We're also advancing two novel cancer antigen therapies to the clinic. mRNA-4106 is a tumor-targeted antigen therapy designed to direct the immune system against multiple shared tumor antigen.

正如我剛才提到的，我們根據令人鼓舞的早期臨床結果優先推進我們的 Checkpoint 計劃。該計畫目前正在針對第一線轉移性黑色素瘤和第一線轉移性非小細胞肺癌進行第 2 期研究評估。我將在下一張幻燈片中回顧該計劃的詳細資訊。我們也將兩種新型癌症抗原療法推向臨床。 mRNA-4106 是一種針對腫瘤的抗原療法，旨在引導免疫系統對抗多種共享的腫瘤抗原。

The first patient has been dosed in a Phase 1 study in solid tumors that is assessing safety, pharmacodynamics, immunogenicity and preliminary efficacy for the program. And we have an open IND for mRNA-4203, which is designed to boost the activity of an engineered T-cell therapy to improve its persistence and effectiveness. This program is being developed in collaboration with Immatics. These cancer entogen therapies, Checkpoint mRNA-4106 and mRNA-4203 are off-the-shelf therapies in contract with intesmarin, which is an individualized cancer treatment. These programs reflect our growing oncology pipeline with more coming soon.

第一位患者已在實體腫瘤的 I 期研究中接受給藥，該研究正在評估該計劃的安全性、藥效學、免疫原性和初步療效。我們有一個 mRNA-4203 的開放 IND，旨在增強工程 T 細胞療法的活性，以提高其持久性和有效性。該計劃正在與 Immatics 合作開發。這些癌症 entogen 療法、Checkpoint mRNA-4106 和 mRNA-4203 是與 intesmarin 簽約的現成療法，是一種個人化癌症治療方法。這些項目反映了我們不斷增長的腫瘤學研發管線，很快就會有更多項目推出。

Now let me provide an overview of the Checkpoint program, mRNA-4359, starting with its mechanism of action. Checkpoint is designed to help a patient's immune system recognize and attack tumor cells by encoding mRNA-based cancer antigens for PD-L1 and IDO. The therapy trains the immune system to recognize upregulation of PD-L1 and IDO by cancer cells and immunosuppressive regulatory T cells. By combining this targeted immune activation therapy with checkpoint inhibition with traditional antibodies such as KEYTRUDA, we aim to enhance the antitumor response. overcoming in innovation and improving the depth and durability of responses.

現在讓我從其作用機制開始概述 Checkpoint 計劃 mRNA-4359。檢查點旨在透過編碼基於 mRNA 的 PD-L1 和 IDO 癌症抗原來幫助患者的免疫系統識別和攻擊腫瘤細胞。此療法訓練免疫系統辨識癌細胞和免疫抑制調節性 T 細胞對 PD-L1 和 IDO 的上調。透過將此針對性的免疫活化療法與檢查點抑制療法與 KEYTRUDA 等傳統抗體相結合，我們旨在增強抗腫瘤反應。在創新中克服困難，提高應對的深度和持久性。

Checkpoint is being evaluated in a Phase 1/2 clinical study, which is now moving and moving forward and enrolling the Phase 2 portion. This study is designed to assess the safety and tolerability of checkpoint, both as a monotherapy and in combination with KEYTRUDA in first-line metastatic non-small cell lung cancer and first-line metastatic melanoma. Key efficacy endpoints will include objective response rate, disease control rate, duration of response and progression-free survival. It is an open-label study.

Checkpoint 正在進行 1/2 期臨床研究評估，目前正在推進並招募第 2 期患者。這項研究旨在評估檢查點作為單一療法以及與 KEYTRUDA 聯合用於一線轉移性非小細胞肺癌和一線轉移性黑色素瘤的安全性和耐受性。關鍵療效終點包括客觀緩解率、疾病控制率、緩解持續時間和無惡化存活期。這是一項開放標籤研究。

In addition to clinical outcomes, we are evaluating T cell profile changes, both in the peripheral blood and within the tumor microenvironment to better understand mRNA-4359 mechanism of action. We shared early Phase 1a data at the ESMO Medical Congress in late 2024, and we're excited and looking forward to sharing the data from the Phase 1b portion of the study at a medical conference later this year. Based on the early encouraging results, we plan to expand checkpoint into multiple additional cancer indications.

除了臨床結果外，我們還在評估週邊血液和腫瘤微環境中的 T 細胞譜變化，以便更好地了解 mRNA-4359 的作用機制。我們在 2024 年底的 ESMO 醫學大會上分享了早期的 1a 期數據，我們很高興並期待在今年稍後的醫學會議上分享該研究的 1b 期部分的數據。根據早期令人鼓舞的結果，我們計劃將檢查點擴展到多種其他癌症適應症。

With that review, I will now hand it over to Stephane.

審查完畢後，我現在將其交給 Stephane。

Thank you, Stephen and Jamey.

謝謝你，史蒂芬和傑米。

We are focused on three priorities. Priority one, to drive sales of approved products. Priority two to focus on our late-stage pipeline to drive sales growth and diversification. Priority three, to deliver cost efficiency across the entire business. Our first priority is to drive the Spikevax and RSV vaccines. We entered 2025 with two approved products which puts us in a better competitive position compared to the beginning of 2024. With our ability to now offer RSV for a full season, we expect to better compete in the respiratory vaccine market. In a recent international media approval should add to sales this year.

我們專注於三個優先事項。首要任務是推動已獲批准產品的銷售。第二大優先事項是專注於我們的後期產品線，以推動銷售成長和多樣化。第三大優先事項是提高整個企業的成本效益。我們的首要任務是推動Spikevax和RSV疫苗。進入 2025 年，我們已擁有兩款核准產品，與 2024 年初相比，這讓我們處於更有利的競爭地位。由於我們現在能夠在整個季節提供呼吸道合胞病毒疫苗，我們期望在呼吸道疫苗市場上有更好的競爭力。在最近的國際媒體的認可下，今年的銷售量應該會增加。

Priority two. We are focused on delivering up to 10 product programs, which we believe will drive sales growth. Together, this 10 anticipated product targets a total addressable market of over $30 billion. As Stephen discussed earlier, we have taken some of our priority programs. For the combination of flu and COVID in age 50 and older, we expect the additional several -- some efficacy data coming soon. For compiling, we'll extend the review and approval timeline to 2026.

第二優先級。我們專注於提供多達 10 個產品計劃，我們相信這將推動銷售成長。總的來說，這 10 款預期產品的目標市場總額超過 300 億美元。正如史蒂芬之前所討論的，我們已經採取了一些優先計劃。對於 50 歲及以上人群的流感和 COVID 組合，我們預計很快就會有更多療效數據。為了編制，我們將審查和批准時間延長至 2026 年。

For Norovirus, the grant timing is dependent on cash accrual, which will mean the potential 2026 or 2027 approval. We are very pleased with the addition of Checkpoint AMC to our new prototype pipeline, mRNA-4359. And finally, for PA, MMA we estimate approvals in 2027 and 2028, respectively. Priority three, drive cost efficiency across the entire business. We've demonstrated our commitment to cost discipline through reduction achieved in 2024 and 2025 to date.

對於諾羅病毒，撥款時間取決於現金累積，這意味著可能在 2026 年或 2027 年獲得批准。我們非常高興 Checkpoint AMC 加入我們的新原型管道 mRNA-4359。最後，對於 PA 和 MMA，我們預計分別在 2027 年和 2028 年獲得批准。第三要務是提高整個企業的成本效率。我們已經透過在 2024 年和 2025 年迄今實現的削減證明了我們對成本控制的承諾。

We remain confident in our ability to further streamline our operating structure for the remaining of 2025 through 2027. We are pleased to announce today the 2027 cash cost target of $4.2 billion giving us additional confidence in achieving our cash breakeven target in 2025. [Proft product] program, we expect important milestones. We filed for approval for three products in 2024 for next-gen COVID, mRNA-1283, or as vaccine for high-risk 18 to 59-year-olds. We look forward to regulatory vision on this. For flu and COVID combination vaccine, we expect an extended review timeline pending positive stand-alone through efficacy data and submission with expecting a '26 approval.

我們仍有信心在 2025 年剩餘時間至 2027 年期間進一步簡化我們的營運結構。我們今天很高興地宣布，2027 年的現金成本目標為 42 億美元，這讓我們對在 2025 年實現現金損益平衡目標更有信心。 [利潤產品] 計劃，我們期待重要的里程碑。我們在 2024 年申請批准三種產品，用於下一代 COVID、mRNA-1283 或作為 18 至 59 歲高風險族群的疫苗。我們期待監管部門對此作出遠見。對於流感和 COVID 聯合疫苗，我們預計審查時間會延長，等待積極的獨立療效數據和提交，並有望獲得 26 年的批准。

For CMV, we look forward to having the final results of our Phase 3 vaccine efficacy study in 2025. We have exceeded the cash accrual goals for full efficacy study and expected without by this summer. On norovirus vaccine is in Phase 3 and the timing of our data will be subject to case accrual. In oncology, the return of our ongoing in this Intismeran Phase 3 adjuvant melanoma trial will be subject to even the course, and we expect to present our Phase 2 five-year durability data in adjuvant melanoma next year.

對於 CMV，我們期待在 2025 年獲得 3 期疫苗功效研究的最終結果。我們已經超額完成了全面功效研究的現金累積目標，預計今年夏天即可實現。諾羅病毒疫苗目前處於第 3 階段，我們的資料發佈時間將取決於病例的累積。在腫瘤學方面，我們在這項 Intismeran 3 期輔助性黑色素瘤試驗中的持續進展將取決於進程，我們預計明年將公佈輔助性黑色素瘤 2 期五年耐久性數據。

As mentioned before, we are very excited by the addition of the Checkpoint AIM-T productized portfolio, and we look forward to sharing data at medical meeting later this year. For PA, we are already generating data for registrational study, and we expect to start a registrational study for MMA this year.

如前所述，我們對 Checkpoint AIM-T 產品組合的加入感到非常興奮，我們期待在今年稍後的醫學會議上分享數據。對於 PA，我們已經在產生註冊研究數據，我們預計今年將啟動 MMA 的註冊研究。

I am very thankful to our team for our progress achieved so far across the commercial organization, our late-stage pipeline, and great cost reduction efforts across the company.

我非常感謝我們的團隊迄今為止在商業組織、後期研發管線以及整個公司的巨大成本削減努力方面所取得的進展。

With this, we'll be happy to take your questions.

我們將很高興回答您的問題。

(Operator Instructions) Salveen Richter, Goldman Sachs.

（操作員指示）高盛的 Salveen Richter。

You noted that based on FDA feedback for Phase 3 Flu efficacy data, you now expect an extended review time line and you're targeting approval in 2026. Could you comment any further on your interactions with the FDA and why they decided to require this? And more broadly, just to the potential risk of the vaccine business outlook under the new administration?

您指出，根據 FDA 對第三階段流感療效數據的回饋，您現在預計審查時間會延長，目標是在 2026 年獲得批准。您能否進一步評論一下您與 FDA 的互動以及為什麼決定這樣做？更廣泛地說，新政府執政下疫苗業務前景的潛在風險是什麼？

Thank you, Salveen, for the question. So first, on the narrow question of the flu study, we have moved forward very quickly in enrolling cases as the FDA and everybody is now aware and actually in that flu efficacy study, which we originally thought might be a two-season efficacy study, we now know that very shortly here, we will have a readout with a very large number of cases in a 40,000-person study.

謝謝 Salveen 提出的問題。首先，關於流感研究這個狹義的問題，正如 FDA 和現在每個人都知道的那樣，我們在招募病例方面進展非常迅速，實際上，在流感療效研究中，我們最初認為這可能是一個為期兩個季節的療效研究，現在我們知道，很快我們將在一項涉及 40,000 人的研究中讀取大量病例的數據。

And since that we'll speak to the potential value of our flu component it makes good scientific sense that, that would be a part of the review that's going on for our flu COVID combination.

既然我們將談論流感成分的潛在價值，從科學角度來看，這將成為我們正在進行的流感 COVID 組合審查的一部分。

I'll remind you, we had already demonstrated efficacy for the COVID component. And really, now we're almost sitting on top of that flu vaccine component. So for a whole bunch of, I think, quite reasonable scientific reasons. It makes sense that we review that as a part of the combination vaccine study, the implication of that is we'll have to complete that review, obviously, hopefully, see a positive result and then submit it to the current BLA for the mRNA-1083 program, that will inevitably lead to some form of clockstop and extension of the review time lines.

我要提醒你，我們已經證明了 COVID 成分的有效性。事實上，現在我們幾乎已經掌握了流感疫苗的成分。所以我認為有很多相當合理的科學原因。作為聯合疫苗研究的一部分，我們對其進行審查是有意義的，這意味著我們必須完成該審查，顯然，希望看到積極的結果，然後將其提交給當前的 BLA 進行 mRNA-1083 計劃，這將不可避免地導致某種形式的時鐘停止和審查時間的延長。

And so we're excited to see those results in flu. We think they will -- we hope they will be constructive for the flu COVID program and look forward to submitting them -- sharing those results first and then summing them once we have them. As far as more broadly, a question about our interactions with the FDA across multiple submissions, those continue business as usual from our side. We continue to have productive exchanges across all of our ongoing final reviews that includes our 1283 program, the RSV program. We continue to be engaged in anticipating seasonal program -- seasonal composition update for this coming fall.

因此我們很高興看到流感的這些成果。我們認為他們會的——我們希望他們能夠對流感 COVID 項目產生建設性作用，並期待提交這些結果——首先分享這些結果，然後在獲得這些結果後進行總結。更廣泛地說，關於我們與 FDA 在多份提交文件中的互動的問題，從我們的角度來看，這些業務仍在照常進行。我們繼續對所有正在進行的最終審查進行富有成效的交流，其中包括我們的 1283 計劃、RSV 計劃。我們將繼續致力於預測今年秋季的季節性計畫—季節性作文更新。

And then obviously, I've just spoken to what's happening in the flu COVID combination space. So from our perspective, we are grateful for the ongoing collaboration work, and we'll continue to make sure that we provide all the data required to conduct a diligent review of all of our products in our portfolio.

顯然，我剛剛談到了流感和 COVID 組合領域正在發生的事情。因此，從我們的角度來看，我們感謝正在進行的合作工作，我們將繼續確保提供所有必要的數據，以對我們產品組合中的所有產品進行認真的審查。

More broadly, I guess the question to outlook, and I invite others to sort of add if I miss anything, but we continue to see an opportunity -- a real need for COVID vaccination particularly this coming fall. And we'll remind that through this winter season, we still saw thousands of deaths in the United States, actually about 1,000 deaths a week during the peak winter months from COVID-19. The overwhelming majority of which were from folks who had not been vaccinated, but were older Americans and had risk factors.

更廣泛地說，我想這個問題與前景有關，如果我遺漏了什麼，我會邀請其他人補充，但我們仍然看到一個機會——對 COVID 疫苗的真正需求，特別是今年秋天。我們要提醒的是，整個冬季，美國仍然有數千人死亡，實際上在冬季高峰期，每週約有 1,000 人死於 COVID-19。其中絕大多數是未接種疫苗但年齡較大的美國人，並且具有風險因素。

And we do believe that vaccines have a unique opportunity to prevent those deaths at those hospitalizations. There was actually a publication of Denmark just this week showing that this past year, our updated vaccine composition was 96% effective at preventing death, 85% effective at preventing hospitalization this year.

我們確實相信疫苗具有獨特的機會來防止住院期間的死亡。事實上，本週丹麥發布的出版物顯示，去年我們更新的疫苗成分在預防死亡方面的有效性為 96%，在預防住院方面的有效性為 85%。

And so we do believe that there is a need, and we believe there's an opportunity with vaccines to play an important role in public health, ultimately, people need to make their own decisions about that. So our focus right now is making sure that those products -- our products are available for American and for in markets around the world for the coming fall cold season.

因此，我們確實相信有此必要，我們相信疫苗有機會在公共衛生中發揮重要作用，最終，人們需要對此做出自己的決定。因此，我們現在的重點是確保這些產品——我們的產品能夠在即將到來的秋季寒冷季節供應給美國和世界各地的市場。

(Operator Instructions) Eliana Merle, UBS.

（操作員指示）Eliana Merle，瑞銀。

Hey this is Jasmine on Eli. Thanks so much for taking our question. So what's the latest on your thinking, whether it's seen INT Phase 3 data in 2026 is still a reasonable expectation. I'm wondering what your plans are for new trials, expansions and other indications for both INT and the newly prioritized Checkpoint?

嘿，我是 Eli 上的 Jasmine。非常感謝您回答我們的問題。那麼您最近的想法是什麼，2026 年看到 INT 第三階段的數據是否仍然是一個合理的預期。我想知道您對 INT 和新優先檢查點的新試驗、擴展和其他指示有什麼計劃？

Sure. Thank you for the question. So first, I'll remind you that the Phase 3 melanoma study, it reached its target enrollment in September of 2024. Last year, we announced that. Given the historical event rates that would lead us to expect that we would have accrued enough events for at least the first analysis of efficacy in 2026. And so we are still ultimately waiting for events, and it will be event-driven, whether that analysis happens. But based on our prior experiences, both in Phase 2b and the other expectations, we still believe the '26 readout is possible, if not likely.

當然。謝謝你的提問。首先，我要提醒您，第三階段黑色素瘤研究已於 2024 年 9 月達到目標招募人數。去年，我們宣布了這一點。考慮到歷史事件發生率，我們預計我們將累積足夠的事件，至少在 2026 年進行第一次療效分析。因此，我們最終仍在等待事件發生，並且無論分析是否發生，它都將由事件驅動。但根據我們先前在第 2b 期和其他預期中的經驗，我們仍然相信 26 年的讀數是可能的，即使可能性不大。

For other indications, we haven't provided updates, obviously, for the non-small cell lung cancer study. We're really pleased with that enrollment, but we haven't provided a specific update on timeline there. And for the Phase 2 studies, we did, as you noted, recognize that we've now fully enrolled the randomized study in renal cell carcinoma, which is exciting, because that randomized study has a chance of a readout. We have not, with our partner, Mark guided when we expect that will be, but I will note that events do accrue relatively quickly in that indication in that population.

對於其他適應症，我們顯然沒有提供非小細胞肺癌研究的最新進展。我們對招生情況感到非常高興，但我們還沒有提供具體的時間表更新。對於第二階段研究，正如您所說，我們確實認識到我們現在已經完全納入了腎細胞癌的隨機研究，這令人興奮，因為該隨機研究有機會閱讀。我們和我們的伴侶馬克還沒有告訴我們預計何時會發生這種情況，但我要指出的是，在那個人群中，這種情況確實會相對較快地發生。

So we'll look forward to that. We will continue to look to expand perhaps into monotherapy spaces, both ourselves and Merck have indicated that, and we have an instance of that. that we're bringing forward today. There will hopefully be others, but I will defer from commenting on them until we and Merck are ready to announce that we've started those efforts.

所以我們對此充滿期待。我們將繼續尋求擴展到單一療法領域，我們自己和默克公司都已表示了這一點，而且我們有一個這樣的例子。我們今天要提出的。希望還會有其他舉措，但我將推遲對它們進行評論，直到我們和默克公司準備宣布我們已經開始這些努力。

On the question of Checkpoint, we are obviously encouraged. We would like -- we look forward to sharing the data that's the basis of that encouragement at an upcoming medical meeting. because we've been looking at that program very carefully in its Phase 1b portion of the study, which I'll remind you is a combination with antibody checkpoints to see whether or not we can see a synergistic effect.

關於檢查站的問題，我們顯然受到了鼓舞。我們希望——我們期待在即將舉行的醫學會議上分享作為這種鼓勵基礎的數據。因為我們一直在非常仔細地研究該項目的第 1b 階段，我要提醒您，這是與抗體檢查點的結合，以查看我們是否可以看到協同效應。

And we're currently moving forward in at least two histologies that we talked about today. So that first-line non-small cell cancer in the first-line metastatic indication Obviously, we have also been looking at it in second-line indications as a part of that Phase 1 program, and we'll continue to do so. We will add additional histologies in the future, but we're not ready to announce any today.

目前，我們正在今天討論的至少兩種組織學方面取得進展。因此，一線非小細胞癌在轉移性適應症中的一線治療顯然也作為第一階段計劃的一部分在二線適應症中得到研究，並且我們將繼續這樣做。我們將在未來添加更多組織學，但今天還不準備宣布任何內容。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Just at the risk of being repetitive here, and just to be clear, more specific, given how close we are to the PDUFA, it's business as usual for the 1283 review. Can you talk about just how interactions are going for that program and what your confidence is in approval given the new leadership and recent denial of the Novavax program?

只是為了避免重複，為了更清楚、更具體，考慮到我們距離 PDUFA 有多近，1283 審查一切照常。您能否談談該計劃的互動進度如何？考慮到新的領導層和最近對 Novavax 計劃的拒絕，您對該計劃的批准有何信心？

Yeah. I mean, obviously, I can't kind of comment on other programs because I'm not familiar with what's going on there in those confidential exchanges. But I can speak to ours, which is it really has been business as usual.

是的。我的意思是，顯然，我無法對其他項目發表評論，因為我不熟悉那些機密交流中發生的事情。但我可以談談我們的業務，那就是一切確實一切如常。

\There are lots of exchanges of scientific information. We really view it as our responsibility to provide high-quality data to all of our regulators, including the FDA so that they can conduct their assessments. To date, those assessments have, we believe, been constructive and positive. And we have seen no sign that we're in -- that there's any question about our ability to make the existing PDUFA date.

\有很多科學資訊的交流。我們確實認為我們有責任向包括 FDA 在內的所有監管機構提供高品質的數據，以便他們進行評估。到目前為止，我們認為這些評估都是建設性的和積極的。我們沒有看到任何跡象表明我們有能力按照現有的 PDUFA 日期完成交易。

Now again, review is ongoing, and we have to defer to what questions may come from the FDA or others as we move forward. but it really has felt like business as usual.

現在，審查仍在進行中，我們必須考慮 FDA 或其他機構可能提出的問題。但確實感覺一切如常。

Michael Yee, Jefferies.

麥可‧餘 (Michael Yee)，傑富瑞集團 (Jefferies)。

This is Diana on for Mike. Just a quick question about a recent media article that came out yesterday. regarding how vaccine trials would be run that they would now require to be run against placebo. Just wanted to get your thoughts about that. What do you think that will do to enrollment? Will it be harder enroll easier -- and is that going to be required, do you think, for all respiratory vaccines, specifically covered for you guys or just newer vaccines such as CMV or any others that you're working on in the product line?

這是戴安娜為麥克表演的。我只是想問一下關於昨天發表的一篇媒體文章的問題。關於如何進行疫苗試驗，現在需要針對安慰劑進行試驗。只是想聽聽你對此的想法。您認為這會對入學產生什麼影響？註冊會變得更難還是更容易？您認為這是否是所有呼吸道疫苗（特別是您們承保的疫苗）的必需要求，還是僅適用於較新的疫苗（例如 CMV 疫苗或您正在產品線中研究的任何其他疫苗）？

Thank you for the question. So we're -- I would say comment on a policy change that either hasn't happened or that we haven't been communicated directly to us. I will note that as you did our COVID vaccine, our RSV vaccine, our CMV vaccine, our norovirus vaccine, these are all conducted as placebo-controlled studies.

謝謝你的提問。因此，我想對尚未發生或尚未直接告知我們的政策變化進行評論。我要指出的是，正如你們對我們的 COVID 疫苗、RSV 疫苗、CMV 疫苗、諾羅病毒疫苗所做的那樣，這些都是作為安慰劑對照研究進行的。

And for many of the other products in our pipeline, there are portions of their development that happened in placebo-controlled studies, usually earlier clinical development or in certain populations. for instance, our COVID vaccine was studied in children in a placebo-controlled context.

對於我們產品線中的許多其他產品，其開發過程的一部分是在安慰劑對照研究中進行的，通常是早期臨床開發或針對特定族群。例如，我們的 COVID 疫苗是在安慰劑對照的環境下針對兒童進行的研究。

So it will really depend upon ultimately what the FDA and HHS feel is appropriate and their guidance at a program-by-program level of what that will require. Our responsibility as a manufacturing and a drug developer is to make sure that we provide the data that regulators and public health officials feel like they need so that they can stand behind our products. And so we will -- we will absolutely engage constructively and making sure we understand what those needs are and that we fulfill them.

因此，這實際上最終取決於 FDA 和 HHS 認為什麼是合適的，以及他們在具體專案層面上對此需要做什麼的指導。作為製造商和藥品開發商，我們的責任是確保提供監管機構和公共衛生官員認為他們需要的數據，以便他們可以支持我們的產品。因此，我們絕對會以建設性的方式參與，確保我們了解這些需求是什麼，並且我們能夠滿足這些需求。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

This is Chris on for Terence. Just one quick question on the COVID strain selection. So given the regulatory uncertainties, can you please elaborate on the process for the COVID strain selection moving forward?

這是克里斯 (Chris) 代替特倫斯 (Terence)。關於 COVID 株的選擇，我只想問一個簡單的問題。因此，鑑於監管的不確定性，您能否詳細說明未來 COVID 株選擇的過程？

Sure. I will answer from a global perspective, I will start by saying in every instance, it is up to our regulators in now all of these countries to tell us as manufacturers, what updates they may or may not want for the coming year. I will note that some years, flu does not update all of its strains for sure. in some years been so far with COVID, we've had updates every year. There are continuing evolving strains that we are tracking that we think might justify an update this year -- but that decision we're really lie with a set of regulatory bodies.

當然。我將從全球角度來回答，首先我要說的是，在每種情況下，現在所有這些國家的監管機構都有責任告訴我們製造商，在來年他們可能想要或不想要哪些更新。我要指出的是，有些年份，流感病毒株肯定不會更新所有版本。在某些年份，到目前為止，我們每年都會發布有關 COVID 的更新資訊。我們正在追蹤不斷演變的病毒株，我們認為今年可能需要更新——但這項決定實際上取決於一系列監管機構。

First, we will probably, based on timing here from WHO and EMA and other international regulators. And then we would expect to also hear probably at the same time from the US FDA. The process is really up to them how they choose to ultimately conduct their selection process on whether or not they want to do a strain update for this year and what the composition will be, I'll defer to each of those individual regulators. But we would expect within the next month if we follow the same process that we have in prior years to hear from all of them about what they'd like to see us deliver for the fall for their respective countries.

首先，我們可能會根據世界衛生組織 (WHO)、歐洲藥品管理局 (EMA) 和其他國際監管機構的時間來決定。然後我們預計也可能同時聽到美國 FDA 的消息。這個過程實際上取決於他們如何選擇最終進行選擇過程，他們是否要對今年進行菌株更新以及其組成是什麼，我將聽從每個監管機構的意見。但是，如果我們按照往年的相同流程，我們預計下個月就能聽到所有人的意見，了解他們希望我們在秋季為他們各自的國家提供什麼。

Cory Kasimov, Evercore ISI.

Cory Kasimov，Evercore ISI。

I wanted to ask you about the flu COVID combination and the updated timing you have there. You may not know yet, but is it your expectation that you would need to refile that with the updated flu efficacy data? Or could you just submit that data as a -- I guess, what would be considered a major amendment, in other words, potentially delaying this by just three months and enabling a potential FDA decision in early 2026 as opposed to later in the year?

我想問一下您那裡的流感 COVID 組合和最新時間。您可能還不知道，但您是否期望需要使用更新的流感療效數據重新提交該報告？或者您是否可以僅將這些數據作為 - 我想，這將被視為一項重大修正案，換句話說，可能將其推遲三個月並使 FDA 能夠在 2026 年初而不是今年晚些時候做出決定？

Thank you for the question. And I think the short answer will be, we don't know. It will ultimately depend upon consultation with the FDA of what they would prefer the approach to be. It is totally appropriate to submit that data as an amendment to the BLA.

謝謝你的提問。我認為簡短的回答是，我們不知道。這最終將取決於與 FDA 的協商，以了解他們希望採用哪種方法。將該數據作為 BLA 的修正案提交是完全合適的。

It could also be from a pragmatic perspective, it makes sense to update more broadly the BLA submission with it, which could result in resubmission. We'll just go forward with whatever feels like the most pragmatic approach and ultimately, the one that the FDA guides us to do.

從務實的角度來看，更廣泛地更新 BLA 提交是有意義的，這可能導致重新提交。我們將採取最務實的方法，並最終按照 FDA 的指導方法進行。

I will say that absent that, there is a lot of other information in the current file, including the performance of the COVID component, obviously, things on manufacturing, the broader immunogenicity and safety data set from the pivotal Phase 3 for the flu covid combo and the review of all that information is progressing.

我想說的是，除了這些資訊之外，當前文件中還有很多其他信息，包括 COVID 組件的性能，顯然還有製造方面的內容，來自流感 covid 組合關鍵第 3 階段的更廣泛的免疫原性和安全性數據集，並且所有這些信息的審查正在進行中。

And so there are reasons why amending with the flu efficacy data may be the most pragmatic approach. But again, it will depend upon consultations with the FDA, which will only be appropriate to do after we have that flu efficacy data in hand.

因此，有理由相信，根據流感療效數據進行修改可能是最務實的方法。但同樣，這將取決於與 FDA 的磋商，而只有在我們掌握流感療效數據後，這樣做才是合適的。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

The main kind of focus for us is really on kind of some of the new cost cutting that you guys have announced today. What we would really like to understand is kind of what particular milestones or expectation changes drove you to increase the cost-cutting program. I think you've been quite explicit in the past that you'll be looking for top line signals to drive new changes there?

我們主要關注的是你們今天宣布的一些新的成本削減措施。我們真正想了解的是，哪些特定的里程碑或期望變化促使您增加成本削減計劃。我認為您過去已經非常明確地表示過，您將尋找頂線訊號來推動那裡的新變化？

And then kind of the second question is what components would you point to as being kind of those where you've felt you've been able to flex to enable kind of some of that cost cutting that we're now into additional cost cutting that we're now anticipating in 2026 and 2027 from last expectations?

然後第二個問題是，您認為哪些因素可以靈活運用，以實現部分成本削減，我們現在正在進一步削減成本，根據上次的預期，我們預計 2026 年和 2027 年將實現這些成本削減？

Yeah. Thanks for the question, Courtney. As to the first piece in terms of what are the milestones or what's changed. A lot of this is nothing has changed. So we were expecting and we've been indicating that we are right now going through a lot of Phase 3, large Phase 3 trials. In RSV, CMV, norovirus, our combination vaccine, flu and many of those just ramped down and are completed by 2027. And we had never really given guidance for 2027. So much of this was just extending our guidance out a year and indicating just what that R&D level will be.

是的。謝謝你的提問，考特尼。至於第一部分，關於里程碑是什麼或發生了什麼變化。其中很多都沒有任何改變。因此，我們期待並且已經表明我們現在正在進行大量的 3 期、大型 3 期試驗。對於呼吸道合胞病毒、鉅細胞病毒、諾羅病毒，我們的聯合疫苗、流感疫苗以及其中許多疫苗的研發工作才剛開始，並將於 2027 年完成。我們從未真正給予 2027 年的指導。其中很大一部分只是將我們的指導延長一年，並表明研發水準將會達到什麼水準。

The second thing is as to a milestone. I mean, yes, it's an uncertain environment. So there's nothing from a revenue perspective that we have seen that would indicate that we need to do this, but we need to focus on what we can control. and that is our cost base. And as we look out to 2027 and 2028, we felt that it was appropriate to get our cash cost to about $4 billion to make sure that we fulfill on our commitment to breakeven by 2028.

第二件事是關於里程碑。我的意思是，是的，這是一個不確定的環境。因此，從收入角度來看，我們沒有看到任何跡象表明我們需要這樣做，但我們需要專注於我們能夠控制的事情。這就是我們的成本基礎。展望 2027 年和 2028 年，我們認為將現金成本控制在 40 億美元左右是合適的，以確保我們履行到 2028 年實現收支平衡的承諾。

Now as to the how, I already mentioned the large majority of it, which is the Phase 3 trials, but we have been on a cost efficiency program for the last couple of years, as I mentioned in my prepared remarks. So there's much to do and the teams continue to identify additional opportunities in procurement. We're using digital tools or relooking how we get work done.

至於如何進行，我已經提到了其中的大部分，即第三階段試驗，但正如我在準備好的發言中提到的那樣，過去幾年我們一直在實施成本效益計劃。因此，還有很多工作要做，團隊將繼續在採購方面尋找更多機會。我們正在使用數位工具或重新審視我們完成工作的方式。

And so we just think that there's a lot that we can go do and our -- that's why we came out with new 2027 guidance. Just as we look out, some of this is as expected. Some of this is the continued improvements that our teams see and we look forward to executing on it and fulfilling our commitment to breakeven by 2028.

因此，我們認為我們可以做很多事情——這就是我們推出新的 2027 年指導的原因。正如我們所看到的，其中一些是在預料之中的。其中一些是我們的團隊看到的持續改進，我們期待執行這些改進並履行 2028 年實現收支平衡的承諾。

Myles Minter, William Blair.

邁爾斯·明特、威廉·布萊爾。

It's Dick on for Myles. First, for norovirus, have you guys identified the source of the GBS case that was originally identified the FDA? And have there been any additional cases of GBS noted in the Northern Hemisphere or Southern Hemisphere trials?

迪克替換邁爾斯。首先，對於諾羅病毒，你們是否已經確定了 FDA 最初發現的格林巴利症候群病例的來源？在北半球或南半球的試驗中是否也發現了其他格林-巴利症候群病例？

And then second, for Intismeran for the study in which you quantified the number of T cell clones induced, we're curious how you're comparing that to BioNTech product and whether you use the same analysis pipeline that they've use for their quantification for your sequencing data.

其次，對於 Intismeran 的研究，您量化了誘導的 T 細胞克隆的數量，我們很好奇您如何將其與 BioNTech 產品進行比較，以及您是否使用他們用於量化測序數據的相同分析流程。

Thanks for both questions. So first, yes, on the norovirus study, yes, we're pleased that the clinical hold has been lifted. Obviously, what means we've sort of satisfied any of the questions and importantly, updated materials that were from an informed consent perspective, all that's out there. We have not seen an additional GBS case, obviously. That's encouraging, but not necessarily unexpected. It is unfortunately rare about when it does occur.

感謝您提出這兩個問題。首先，關於諾羅病毒研究，我們很高興臨床暫停已經解除。顯然，這意味著我們已經回答了所有問題，而且重要的是，從知情同意的角度更新了所有現有的資料。顯然，我們還沒有發現新的格林-巴利症候群病例。這令人鼓舞，但不一定出乎意料。不幸的是，這種情況很少發生。

As far as causality, we may never know -- I will remind you that there are GBS cases in the background population, particularly in older adults that happen fairly regularly. several per hundred thousand, and we're enrolling these large 25, 000, some 50,000 person studies over multiple years. We do see occasional GBS cases actually on the placebo arms of these studies. and now we've seen one in active. It's possible that it's related to the vaccine. It's possible that it's not. And we are working hard to assess causality, but you can't really ever get a direct length.

至於因果關係，我們可能永遠不會知道——我要提醒你，在背景人群中存在格林-巴利綜合症病例，特別是在老年人中，這種情況相當常見。每十萬人中就有幾個人，我們計劃在數年內招募 25,000 到 50,000 人進行大規模研究。我們確實在這些研究的安慰劑組中偶爾看到格林-巴利綜合症病例。現在我們已經看到一個活躍的。有可能和疫苗有關。有可能不是。我們正在努力評估因果關係，但實際上無法獲得直接的長度。

What you really can do though is characterize the frequency of these things and make sure that people are aware of them. And as a part of our ongoing Phase 3 norovirus study, we'll continue to very actively monitor for additional cases of GBS, we certainly hope we don't see any either on the placebo arm one. But all of that pretty -- we're pretty encouraged, again, just to be off-clinical hold and moving forward with enrollment and hopefully, moving forward with that program.

但你真正能做的是描述這些事情發生的頻率並確保人們意識到它們。作為我們正在進行的 3 期諾羅病毒研究的一部分，我們將繼續積極監測更多格林巴利症候群病例，我們當然希望在安慰劑組中也不會看到任何病例。但所有這些都非常令人鼓舞——我們再次受到鼓舞，只是暫停臨床研究並繼續進行招募，並希望繼續推進該計劃。

The Intismeran question. So I can't speak to the way BioNTech had run their pipelines. Obviously, we're not deeply familiar with it. We are really encouraged by the clonality that we're seeing in TCRs. I think it's some evidence that we're really deepening and broadening the response and that those are matched by what's happening in the vaccine, that sort of translational data that ultimately is supportive of what is the really exciting evidence of efficacy that we've already seen from that study.

Intismeran 問題。所以我無法談論 BioNTech 運行其管道的方式。顯然，我們對此並不十分熟悉。TCR 中觀察到的克隆性確實令我們感到鼓舞。我認為有證據表明我們確實在深化和擴大應對措施，而且這些與疫苗研發的進展相匹配，這種轉化數據最終支持了我們已經從該研究中看到的真正令人興奮的療效證據。

And I think that, that's ultimately just giving us some of the vibe, but the what was the remarkable hazard ratio improvement that we've reported both at ASCO last year and that we'll look to be updating as we continue to follow that Phase 2b study.

我認為這最終只是給我們一些感覺，但我們去年在 ASCO 上報告的顯著風險比改善是什麼，我們將在繼續追蹤 2b 期研究時更新這一點。

Gena Wang, Barclays.

巴克萊銀行的 Gena Wang。

I have two quick questions. One is when we look at the COVID revenue this quarter, the US was only $29 million and seems only a fraction of the Pfizer US revenue. So any concerns of the future market share change? And the second question is regarding the flu vaccine interim data in Summer '25. Could you please share your total events that you plan to achieve?

我有兩個簡單的問題。一是，當我們查看本季的 COVID 收入時，美國的收入僅為 2,900 萬美元，似乎只是輝瑞美國收入的一小部分。那麼，您對未來市場佔有率的變化有什麼擔憂嗎？第二個問題是關於 2025 年夏季流感疫苗中期數據。您能否分享您計劃實現的所有活動？

So Gene, I'll take the first question. I'm not sure if we heard the second question, so we might ask you to repeat that. Yes. I mean we looked at the Q1 revenue for ourselves and our competitors. And all we can point everybody to is the actual script data. And the script data through the first part of this year is really pretty similar to last year and 38% market share. And even if you go back to last year and you normalize our revenue in the US, we've talked about in the past, $1.7 billion, take out the gross to net changes. It's really $1.5 billion. That across that marketplace is a 40% market share.

那麼 Gene，我來回答第一個問題。我不確定我們是否聽到了第二個問題，所以我們可能會請你重複一次。是的。我的意思是我們查看了我們自己和競爭對手的第一季收入。我們能向大家指出的只是實際的腳本數據。今年上半年的劇本數據與去年非常相似，市佔率為 38%。即使你回到去年，並將我們在美國的收入正常化，我們過去曾談到過，17 億美元，扣除總收入與淨收入的變化。實際上是15億美元。整個市場的份額為 40%。

And that's exactly what we see, I guess, 38% scripts data. That's what we see through the first half. I would also say that our customers are trying to manage their working capital better. So their inventory levels are down, so I can't comment on other companies' revenue, but I can comment on what we see in the actual marketplace from a script perspective.

我想，這正是我們所看到的 38% 腳本數據。這就是我們在上半場看到的。我還想說，我們的客戶正在努力更好地管理他們的營運資金。因此他們的庫存水準下降了，所以我無法評論其他公司的收入，但我可以從腳本的角度評論我們在實際市場上看到的情況。

And Gena, we didn't quite hear the second question. Could you just repeat it, please?

吉娜，我們沒聽清楚第二個問題。請您再說一次好嗎？

Of course. So the second question is regarding the flu vaccine, the ATC data in Summer '25. I don't know if you would be able to share regarding the total events and the stats around it that you plan to achieve?

當然。第二個問題是關於流感疫苗，即 2025 年夏季的 ATC 數據。我不知道您是否可以分享您計劃實現的總體事件及其統計數據？

I don't think we have provided any guidance on it. It is obviously a very large number cases because there was quite a large (inaudible) year. But at this point, I don't think we're going to provide any guidance. We're ultimately just going to conduct that analysis literally the season is over, and we'll try and share those results and then obviously explain them once we've released that.

我認為我們還沒有提供任何有關此的指導。顯然，這是一個非常大的數字，因為那一年發生的事相當多（聽不清楚）。但目前，我認為我們不會提供任何指導。我們最終會在賽季結束後進行分析，我們會嘗試分享這些結果，然後在發布後對其進行解釋。

Jeff Meacham, Citigroup.

花旗集團的傑夫‧米查姆。

Good morning. This is Dave on for Jeff. Just broadly thinking about the recent ACIP meeting. Just wondering if you could comment broadly on some of the comments that you made, namely on CMV and you need for durability data and its implementation challenges and for COVID perhaps the possibility to move from a universal recommendation to when it's risk based. And then separately for the new checkpoint program, given the cost cuts that you guys are not implementing, could you please share perhaps any potential to out license or even partner program in the future.

早安.我是戴夫，代替傑夫。只是廣泛地思考一下最近的 ACIP 會議。只是想知道您是否可以廣泛評論您提出的一些評論，即關於 CMV 以及您需要的耐用性數據及其實施挑戰，以及對於 COVID，也許有可能從普遍建議轉變為基於風險的建議。然後，對於新的檢查點計劃，考慮到您沒有實施的成本削減，您能否分享一下未來可能推出的許可證甚至合作夥伴計劃的任何潛力。

So first on CMV, look, I think we're -- we do recognize for that vaccine we'll want to see good durability. 5, 10 years would be ideal if not longer, because at the end of the day, what you're trying to do with CMV is seroconvert people so they can control and prevent really a substantial infection with the virus. The durability data we've got to date actually looks really strong.

因此，首先關於 CMV，我認為我們 — — 我們確實認識到，對於該疫苗，我們希望看到良好的耐久性。 5 年、10 年是理想的，甚至更長，因為歸根結底，你對 CMV 所做的就是讓人們發生血清轉化，這樣他們就可以控制和預防病毒的大規模感染。我們迄今為止獲得的耐用性數據實際上看起來非常強勁。

So if you look at the antibody titers through 3 years now and similar cell-mediated immunity, but focusing on the neutralizing titers, they're essentially flat 2 to 3 years. And if you model that forward, it does look like it's going to meet our objectives for really durable immune responses.

因此，如果您觀察 3 年來的抗體滴度和類似的細胞介導免疫，但關注中和滴度，它們在 2 到 3 年間基本持平。如果你對此進行建模，它看起來確實會滿足我們真正持久的免疫反應的目標。

That's incredibly encouraging. We've seen in a related program in EBV, real durability and viral suppression. We previously reported on that. And so we're pretty -- we're feeling pretty optimistic about the performance of the latent vaccine platform and specifically CMV and our ability to achieve durability.

這真是令人鼓舞。我們在 EBV 相關程序中看到了真正的耐久性和病毒抑制。我們之前對此進行過報道。因此，我們對潛在疫苗平台的性能，特別是 CMV 以及我們實現持久性的能力感到非常樂觀。

As far as the ACIP conversation on that, we were actually quite encouraged by how constructive people are about the need for a CMV vaccine that any efficacy there will be seen as valuable because at the end of the day, this virus is a scourge, and so while durability was raised, we actually think we've addressed that question and the question of efficacy, we feel pretty aligned with that conversation and optimistic that our current results will be positive.

就 ACIP 對此的討論而言，我們對人們對 CMV 疫苗必要性的建設性態度感到非常鼓舞，任何功效都將被視為有價值的，因為歸根結底，這種病毒是一種禍害，因此，雖然提出了耐用性問題，但我們實際上認為我們已經解決了這個問題和功效問題，我們與那次談話非常一致，並樂觀地認為我們目前的結果將是積極的。

The question on COVID and changes in recommendation. Look, at the end of the day, it is for public health officials to decide how to use our products, our responsibility to bring forward the data that allows them to make that decision. risk-based decisions have been applied in other countries. Certainly, if you look at the types of populations that have been identified, those that are older adults, 65 plus those who have any risk factor. In fact, 74% of Americans had risk factor for severe COVID-19, including under the age of 64, that there was real support for that.

關於 COVID 和建議變化的問題。看，歸根結底，如何使用我們的產品是由公共衛生官員決定的，我們有責任提供數據以便他們做出決定。基於風險的決策已在其他國家應用。當然，如果你看看已經確定的人口類型，那些是老年人，65 歲以及具有任何風險因素的人。事實上，74% 的美國人有嚴重 COVID-19 的風險因素，包括 64 歲以下的人群，這一點確實有證據支持。

And then there was general support for let people decide I think that was seen in the polling of the ACIP working group. So for those even without risk factors that might want to protect themselves again COVID, they should the right to do it. I will note that if you look at death and hospitalization data, it tends to be in the older adults. It tends to be in the in those with risk factors.

然後大家普遍支持讓人們決定，我認為這是在 ACIP 工作小組的民意調查中看到的。因此，對於那些即使沒有風險因素但想要再次保護自己免受 COVID 侵害的人來說，他們應該有這樣做的權利。我要指出的是，如果你查看死亡和住院數據，你會發現這種情況往往發生在老年人身上。它往往發生在具有風險因素的人群中。

And so it makes sense that we will want to encourage strongly vaccination in those populations. Again, 1,000 Americans a week dying through this past winter is more than died in traffic accidents per week. It's really something we must address.

因此，我們大力鼓勵這些人群接種疫苗是有道理的。再者，去年冬天每週有 1,000 名美國人死亡，比每週死於交通事故的人數還多。這確實是我們必須解決的問題。

As far as the Checkpoint program is concerned, -- we have -- we're really encouraged by that data. We're moving forward. At this point, one of the reprioritizations you saw in our pipeline is that we decided not to invest in a pivotal study for younger adult combination vaccines. That's the 18- to 49-year-old flu COVID and combo vaccine.

就 Checkpoint 計劃而言，這些數據確實讓我們深受鼓舞。我們正在前進。目前，您在我們的產品線中看到的優先順序調整之一是，我們決定不投資針對年輕人聯合疫苗的關鍵研究。這是針對 18 至 49 歲人群的流感 COVID 和聯合疫苗。

And really, what you should interpret with that is that we are reprioritizing that investment into our oncology pipeline based on the emerging data. It's not any disservice to the -- or any problem with the 1083 program, we're actually really encouraged by it, but we're going to focus there on older adults and those that are higher risk and we're going to take the opportunity to reinvest that money in a Checkpoint, which we are encouraged to move forward with ourselves.

實際上，您應該這樣理解：我們正在根據新出現的數據重新調整對腫瘤學研發管線的投資優先順序。這對 1083 計劃沒有任何損害或問題，事實上我們真的受到了它的鼓舞，但我們將把重點放在老年人和那些高風險人群身上，我們將藉此機會將這筆錢重新投資到檢查站，我們鼓勵自己繼續前進。

Yes. And maybe just to add to Stephen's point because I think it's an important strategic consideration. As we've said at several days respiratory is a very important franchise for us, whereas Stephen said, incredible medical needs for many, many years to come, unfortunately, for the patients. R&D costs as those Phase 3s are behind us, R&D costs in respect are coming down. That business is generating cash flow. We don't need to invest in manufacturing. And as Stephen said, we really want to be thoughtful about deploying that capital to about oncology.

是的。也許只是為了補充史蒂芬的觀點，因為我認為這是一個重要的策略考量。正如我們幾天前所說的那樣，呼吸科對我們來說是一個非常重要的科室，而史蒂芬說，不幸的是，未來很多年，患者都將面臨巨大的醫療需求。研發成本隨著第三階段的結束，相關研發成本正在下降。該業務正在產生現金流。我們不需要投資製造業。正如史蒂芬所說，我們確實希望認真考慮將這些資金投入腫瘤學領域。

We are very excited about our Intismeran programs, of course, but as Merck is funding half of it. And so that's why when we see opportunities in the clinical data we are seeing on Checkpoint we are able to pivot very quickly, which we think is very important to really have a company with a strong respiratory business, joining cash and investing in growth on therapeutics. That's where we were going.

當然，我們對我們的 Intismeran 計畫感到非常興奮，但默克公司只資助了其中的一半。因此，當我們在 Checkpoint 上看到的臨床數據中看到機會時，我們能夠非常迅速地轉變方向，我們認為這對於真正擁有一家擁有強大呼吸業務、加入現金並投資於治療增長的公司非常重要。那就是我們要去的地方。

Luca Issi, RBC CM.

Luca Issi，RBC CM。

This is Shelby on for Luca. Maybe following up on the political landscape. RFK is on record arguing there is no evidence that a single antigen vaccine ever worked for respiratory diseases. He also claims he is working on multiantigen vaccines. Do you know what he means by that? And also, maybe bigger picture, how confident are you that your upcoming PDUFA will be reviewed based on the risk benefit profile of the molecules and not political agendas. Any thoughts much appreciated.

這是謝爾比 (Shelby) 為盧卡 (Luca) 表演的。或許會關注政治情勢。羅伯特·甘迺迪曾公開表示，沒有證據顯示單一抗原疫苗能夠有效治療呼吸道疾病。他還聲稱自己正在研究多重抗原疫苗。你知道他那句話的意思嗎？而且，也許從更大的角度來看，您對即將出台的 PDUFA 將根據分子的風險收益狀況而不是政治議程進行審查有多大信心。任何想法都值得感激。

Thanks for the question. As far as the Secretary's statements, I think you'd have to refer those questions to him. I can't comment because ultimately, it will depend upon his perspective. I will note that we have products that have been approved that had demonstrated efficacy. And so we'll continue to provide data hopefully, in support of that because we do ourselves believe that the clinical trials we run really to support the benefits of our products, including those that are single antigen, and we have some multi-antigen products.

謝謝你的提問。至於國務卿的聲明，我認為你必須向他提出這些問題。我無法評論，因為最終這將取決於他的觀點。我要指出的是，我們的產品已經獲得批准，並被證明是有效的。因此，我們希望繼續提供數據來支持這一點，因為我們自己相信，我們進行的臨床試驗確實支持了我們產品的優勢，包括單一抗原產品，以及一些多抗原產品。

I'll remind you that CMV is a seven mRNA massive multi-antigen product, as is EBV as are many of our other vaccines. And so we are -- we do believe that sometimes single antigen makes sense and some at multiple antigen make sense, and we do both. As far as the question on our PDUFA date, we -- as I said a moment ago, we continue to have constructive exchanges of data and information with the FDA in the review of all of our files, we've also been participating in the review of the information with the ACIP CDC working groups that ultimately also recommend these products.

我要提醒您的是，CMV 是一種七種 mRNA 大規模多抗原產品，EBV 和我們的許多其他疫苗也是如此。所以我們——我們確實相信，有時單一抗原是有意義的，有時多個抗原是有意義的，我們兩種方法都採用。就我們的 PDUFA 日期問題而言，正如我剛才所說，我們在審查所有文件時繼續與 FDA 進行建設性的數據和資訊交換，我們也一直在參與 ACIP CDC 工作組的資訊審查，最終他們也會推薦這些產品。

Our responsibility is to make sure they have the information they need to do a risk-benefit analysis to follow the science where it leads. We are confident in the data we have. In the case of our next-generation COVID vaccine, I'll point to the fact that, that is an 11,000-person large, multiyear randomized efficacy studies.

我們的責任是確保他們擁有進行風險收益分析所需的信息，以遵循科學的指導。我們對所掌握的數據充滿信心。就我們的下一代 COVID 疫苗而言，我要指出的是，這是一項涉及 11,000 人的大型多年隨機功效研究。

And we think it is a really strong demonstration of the potential for that product to help patients against COVID-19. And so we're quite enthusiastic about it. Most of our other files include similarly large or larger Phase 3 randomized studies. It's quite a lot of information to get through.

我們認為這有力地證明了該產品幫助患者抵抗 COVID-19 的潛力。因此我們對此非常熱衷。我們的大多數其他文件都包括類似規模或更大規模的 3 期隨機研究。需要了解的資訊相當多。

And our job is to make sure that we present it objectively to the agencies so they can conduct its reviews. We remain confident that those reviews will be consistent with prior practice. And again, it has been business as usual for the first half of this year for us.

我們的工作是確保客觀地向各機構呈現數據，以便他們進行審查。我們仍然相信這些審查將與先前的做法一致。今年上半年我們的業務一切如常。

Thank you. Ladies and gentlemen, this does conclude the Q&A portion of today's conference. I'd like to turn the call back over to Stephane Bancel for any closing remarks.

謝謝。女士們、先生們，今天會議的問答部分到此結束。我想將電話轉回給 Stephane Bancel，請他做最後發言。

Thank you so much for joining us today. As you can see, we are really focused on executing on our strategy. Thank you for participating in the call. We look forward to speaking to you in the coming days or weeks. Thank you. Have a good day.

非常感謝您今天加入我們。如您所見，我們確實專注於執行我們的策略。感謝您參加此次電話會議。我們期待在未來幾天或幾週內與您交談。謝謝。祝你有美好的一天。

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.

女士們、先生們，今天的演講到此結束。現在您可以斷開連接，享受美好的一天。