莫德納 (MRNA) 2024 Q3 法說會逐字稿

Important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. I will now turn the call over to Stefano are trued up enough.

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結果有重大差異的重要風險因素。我現在將把電話轉給斯特凡諾，他們已經足夠了。

Good morning or good afternoon, everyone. Thank you for joining us for ourselves. We will review of our business in the fourth quarter. Jimmy will present our financial results and outlook. Stephen will review our clinical programs. I will then come back and share of key priorities before Q&A. We did a good EUR1.9 billion of revenue in the third quarter. Net income was 17 million barrels. We ended the quarter with cash and investments of 9.2 billion barrels. As you know, formulary and now we have been working to improve productivity in the Company in the third quarter of 2024 compared to Q1 of 2023, we reduced operating expenses by EUR500 million across cost of sales, R&D and SG&A. This figure excludes EUR1.4 billion of resizing charge in the third quarter of 2023. I would like to thank our teams. We've been working hard to achieve these cost savings and will continue our journey to improve our cost efficiencies this year, but probably not benefited from U.S. regulatory approval that was 19 days earlier than it was looking for a spec that was available across all segments of the US healthcare system for manufacturing and logistics teams were able to double the number of buildings and industrial customers comprehensive assessment of last year's COVID vaccine seasonal. Now turning to us. We have seen so far this season for, but conditions in the US retail market, progress on savings of shots in arms in the retail channels as measured by actually via, which includes retail, pharmacies and long-term care. As you can see the graphs on the left, the early approval of a vaccine this year as helped to boost total market backing those above where they were last year at this point in the season. The graph on the right shows weekly bill is which, as you can see in the past few weeks of subleasing decline, one will not the ownership of this government to the end of the season. We are encouraged that the COVID market is starting to prove to be a sizable and durable long-term markets from Motorola. Even at 40% share of retail shots in arms season today. Turning to Slide 7. We've been dividend food to be an acceleration in trends from last year to inform our understanding of where they are additional opportunities to grow with COVID market. There are three major delivery channels for respiratory vaccines in the US retail pharmacies, integrated delivery networks or IDNs, which basically says hospitals and doctors who are part of the networks and the film group government programs, Enova, you can see the retail channel compromised 73% of total US market for COVID that Symbility last year in 2023, COVID vaccines have been, although it may be given to pharmacy setting research, smaller distribution in into our channel. If no cash flow in a true market. How about the distribution by channel is different with much greater emphasis on IBM and governments, Cisco, we continue to present the much greater help rather than flu renewing at this stage. We remain convinced that including the vaccination rate of COVID and Greg, to provide a significant opportunity to improve, probably kept, especially in the adjacent segments and government and other secular. Therefore, as we execute our coming through energy, we see the opportunity to drive the COVID vaccination rates closer to through over time, especially in the under pressure. The Chaps, whereas of course, we could COVID vaccination rate over time is a combination of into the vaccine, which Stephen will discuss shortly. Let's now go to look more than I was going to go back to the asphalt to educate healthcare providers on the importance of complete as it probably kept running negative impact as a much greater growth of CVNS. been of well exploratory analyses and the opportunity to improve public health by following bacterial contamination. As you know, in 2020, through 2020 12 season, we were three tenets of prediction of what we've been through. Secondly, we are going direct to consumer to emphasize the benefit of getting vaccinated. And our most recent campaign highlights then job long COVID and the importance of vaccination to minimize the risk province. Additionally for the type of volume is increasing, the CDC recognize the importance of actually mission, which is reflected by the most recent ACP accommodation for additional copies of these four immunocompromised people and those 60 balance of those in the spring of 2025. Moving on to either be more than our Q3, not unless the assets of about EUR10 million, this was below expectations going into 2024. Unfortunately, the timing of approval and localization, greater CDCOM. idea, which is telling us missing most of contracting season. Additionally, the substantial buildup of inventory in the channel by competitors prior to launch as a negative impact on ourselves. Looking to 2025, we believe that we'll be able to participate from the beginning of the contracting season in the US was a filing for approval of a broader IDA label that will allow to address the 18 to be scenarios, high-risk populations. Additionally, we see the potential for market expansion if regulators recombinant recognition. And finally, we are now starting to receive approval outside the US and we expect to have centers in those market between 25. I am delighted to welcome actually saying to them on the Board of Directors have us and has strong commercial background. We're expecting to have a great addition to our bulk is more than 25 years of commercial experience, most recently as CFO of Bitauto. And before that, our Chief Commercial Officer of GSK advances in ideal member to guide what other forwarders and continue to advance our broad portfolio of products to our commercialization in the next few years. We very much look forward to working with us in the U.S. net. Finally, I'm very pleased to announce the expansion of more than an executive committee, expanding the responsibilities of to current members of the team and adding two new members to the team to help us ensure we execute our strategy and deliver ambitions to patients. First, Steven will expand his role to include the oversight of a full commercial organization, which was well-received divided into Indiana as modality that seen revenues responsible for strategy across the full lifecycle of the company, research and development and medical and commercial to eliminate the executive committee outgrowth of injecting minimum ROE that is being promoted to Executive Vice President Research. Jackie has been promoted to Chief Medical Officer, legal developments of ammunition. The promotion of Jackie and rose to the executive committee is a special makeup of the Company is in the first time in our history that's got promoted internal talent onto the executive committee is a testament to both of those this remarkable colleagues with each spent years, building LED critical areas of our company, and this reflects our commitment to grow and develop our internal talent. At Motorola 2014, our Chief Human Resource Officer, will also expand our becoming Chief People and Digital Technology Officer. The inspection, and I will emphasize the fact of the integration of before culture and digital innovation across the business has lifted. The team works to scale up our business processes. The ask a question of how we should do work constantly be on per night between people and digital technologies, big off-the-shelf software solutions, including our own machine learning algorithm for GPT enterprise and all robotic solution. I would like to thank Stephen interesting for venue expanded role and how that partnership over many years, many years looking follow and to congratulate ROEs and Jackie for not being part of the Company exited committee. With this, let me turn to Jane.

大家早安或下午好。感謝您加入我們。我們將在第四季度審查我們的業務。吉米將介紹我們的財務業績和前景。史蒂芬將審查我們的臨床計劃。然後我會回來分享問答前的關鍵優先事項。第三季我們的營收達到了 19 億歐元。淨利為1700萬桶。本季結束時，我們擁有 92 億桶現金和投資。如您所知，目前我們一直在努力提高公司的生產力，與2023 年第一季相比，2024 年第三季我們在銷售、研發和銷售成本、銷售、一般管理費用方面減少了5 億歐元的營運費用。該數字不包括 2023 年第三季 14 億歐元的規模調整費用。我們一直在努力實現這些成本節約，並將繼續努力提高今年的成本效率，但可能沒有受益於美國監管機構的批准，該批准比我們尋求適用於所有細分市場的規格早了 19 天美國醫療保健該系統的製造和物流團隊能夠對去年的新冠疫苗季節性增加一倍的建築和工業客戶進行全面評估。現在轉向我們。本季到目前為止，我們已經看到美國零售市場的狀況，以實際通路衡量，零售通路在節省開支方面取得了進展，其中包括零售、藥局和長期照護。正如您在左圖中看到的那樣，今年疫苗的早期批准有助於提振整體市場支持率，高於去年此時的水平。右圖顯示了每週的帳單，正如您在過去幾週的轉租下降中所看到的那樣，到本季結束時，人們都不會擁有該政府的所有權。我們感到鼓舞的是，新冠肺炎市場開始被證明是摩托羅拉的一個規模龐大且持久的長期市場。即使在今天的軍火季節零售射擊中所佔的份額也達到了 40%。轉向幻燈片 7。美國零售藥局、綜合配送網路或 IDN 等呼吸道疫苗的三個主要配送管道，基本上就是屬於網路一部分的醫院和醫生以及電影集團政府計畫、Enova，你可以看到零售通路受到了損害 73去年，Symbility在2023 年的美國新冠疫苗市場中所佔的百分比，雖然可能會用於藥房環境研究，但在我們的通路中的分銷量較小。如果真正的市場沒有現金流。各個通路的分佈有所不同，更重視IBM和政府、思科，現階段我們持續提供更大的協助，而不是流感更新。我們仍然相信，包括新冠病毒和格雷格的疫苗接種率在內，可能會提供一個重要的改善機會，特別是在相鄰領域以及政府和其他世俗領域。因此，當我們執行我們的計劃時，我們看到了隨著時間的推移，特別是在壓力下推動新冠疫苗接種率接近完成的機會。當然，隨著時間的推移，我們可以將新冠疫苗接種率與疫苗結合起來，史蒂芬很快就會討論這一點。現在讓我們進一步了解我打算回到瀝青路面上的內容，以教育醫療保健提供者了解完整的重要性，因為隨著 CVNS 的大幅增長，它可能會持續產生負面影響。進行了很好的探索性分析，並有機會透過細菌污染來改善公眾健康。如您所知，在 2020 年，到 2020 年 12 賽季，我們對我們所經歷的事情進行了三個預測。其次，我們將直接向消費者強調接種疫苗的好處。我們最近的活動強調了長期存在的新冠病毒以及接種疫苗以盡量減少風險的重要性。此外，由於數量不斷增加，CDC 認識到實際任務的重要性，這反映在最近的 ACP 安排中，即在 2025 年春季為這 4 名免疫功能低下者和其餘 60 名患者提供了額外的副本。超過我們的第三季度，除非資產約為1000 萬歐元，這低於進入2024 年的預期。這個想法告訴我們錯過了大部分合約季節。此外，競爭對手在推出之前在通路中累積了大量庫存，這對我們產生了負面影響。展望 2025 年，我們相信，我們將能夠從美國合約季節開始就參與申請批准更廣泛的 IDA 標籤，該標籤將允許解決 18 種高風險人群的情況。此外，如果監管機構認可重組，我們也看到市場擴張的潛力。最後，我們現在開始獲得美國以外的批准，我們預計在 25 個市場中設立中心。我們期望在我們的基礎上增加超過 25 年的商業經驗，最近擔任易車財務長。在此之前，我們的 GSK 商務長將推薦理想的會員來指導其他貨運代理，並在未來幾年內繼續推動我們廣泛的產品組合的商業化。我們非常期待與我們美網合作。最後，我非常高興地宣布擴大執行委員會以外的成員，將職責擴大到團隊現有成員，並向團隊增加兩名新成員，以幫助我們確保執行我們的策略並向患者實現雄心壯志。首先，史蒂文將擴大他的職責，包括對一個完整的商業組織進行監督，該組織在印第安納州受到了廣泛歡迎，這種模式將收入負責公司整個生命週期的戰略、研發以及醫療和商業，以消除執行委員會注入最低股本回報率的產物，正在晉升為研究執行副總裁。傑基已晉升為首席醫療官，負責彈藥的合法開發。 Jackie 的晉升並晉升為執行委員會是公司歷史上的第一次將內部人才晉升為執行委員會的特殊組成，這證明了這兩位傑出的同事多年來共同努力，建立了LED 是我們公司的關鍵領域，這反映了我們對成長和發展內部人才的承諾。在摩托羅拉 2014 年，我們的人力資源長也將擔任首席人力和數位技術長。這次檢查，我要強調的是，整個企業的文化和數位創新的融合已經提升。該團隊致力於擴大我們的業務流程。每個晚上，人們和數位技術、大型現成軟體解決方案（包括我們自己的 GPT 企業機器學習演算法和所有機器人解決方案）之間不斷地提出我們應該如何運作的問題。我要感謝史蒂芬對場地擴大的作用以及多年來的合作夥伴關係的關注，並祝賀 ROE 和 Jackie 沒有成為公司退出委員會的成員。說到這裡，讓我轉向簡。

Thanks for the phone, and hello, everyone. Today, I will provide an overview of our financial results for the third quarter and share our outlook for the remainder of 2024. Let's start by reviewing our commercial performance, which you can follow on slide 14. For the third quarter of 2024, our net product sales were $1.8 billion, bringing year-to-date product sales to 2.2 million. We also had approximately $100 million in year-to-date other revenues from grants, collaboration, licensing and royalties, which are not included in the figures on this slide, 1.2 billion of our 3Q 2020 for product sales from the US market, where we experienced an earlier launch to the 2024 2020 19. While our 3Q results exceeded expectations is mainly due to sales timing between the third and fourth quarter, supported by receiving FDA approval of our updated COVID-19 vaccine three weeks earlier than last year. Also included in our US sales of 1.2 billion is a provision release of approximately $140 million, primarily driven by lower product returns from the 2023 2024 season compared to our previous estimate. Additionally, we commenced RSV vaccine sales in Q3, while in the HIFU sales were limited at 10 million, we believe there is potential for long-term growth as we work to capture a larger market share over time. International sales of 0.6 billion were in line with our expectations for lower compared to the same period in 2023 when sales benefited from the fulfillment of quarters deferred from 2022. For full year 2024 outlook, we are reaffirming our product sales adjustment of three to $3.5 billion, which implies a 4Q product sales range of 0.8 to 1.3 billion. We expect our US 4Q product sales to be between 205 hundred million dollars range is driven by the following. three key variables are slightly our market share, which is currently tracking to approximately 40% in retail. At this time, it's too early to call a share in and year end and with the governments next vaccination rates arrangements in the market size, which as COVID vaccinations flat to down 10% versus the prior year. Finally, our performance in and the ultimate size of the RCV market in 2024. To summarize, yes, our retail market share remained constant at 40% and the US market finishes the season down 10% compared to last year. And there is no uptick in RSV sales. We expect to be on the low end of the sales range. We expect our international Ford's new product sales to be between 608 hundred million. We have a tighter range on our international sales as most of these sales are for contracted volumes and confirmed orders. The final international sales amount will be dependent upon revenue recognition, timing and our performance in a few specific markets. Moving to slide 15, I will talk about our 3Q financial resulted in more details. Net product sales for Q3 were 1.8 billion. As I just discussed on the prior page, our cost of sales for 3Q 20, presenting 28% of net product sales for the quarter. This was 77% year over year decline in our cost of sales from $2.2 billion in Q3 2023. As a reminder, last year, we undertook a strategic initiative to restructure our manufacturing footprint and recorded $1.4 billion of charges in 3Q 2023 from inventory write-downs, CMO wind-down costs and cancellation fees. Excluding the $1.4 billion charge, cost of sales still deploy and by 13% year over year as we continue to make progress driving additional productivity improvements in our manufacturing operations. R&d expenses were $1.1 billion in Q3 2024, reflecting a 2% year over year decline from $1.2 billion last year. We purchased a priority review voucher during the third quarter of 2024, which is included in our Q3 results. Excluding the PRV purchase, we had a strong year over year spending declines for research development and clinical manufacturing as we continue to drive cost efficiencies across all areas of the organization. Sg&a expenses for Q3 2024 were $281 million, representing a 36% year over year reduction. This decline reflects our focus on driving cost efficiency and making targeted investments that continue to strengthen our overall productivity. I will provide further details in the following slides. We recognized an income tax of 8 million for the third quarter, a significant reduction from the 1.7 billion in the same period last year. The decrease was largely attributable to the establishment of a $1.7 billion valuation allowance on deferred tax assets in Q3 2023. The valuation allowance has remained inflations, its initial recognition and continues to impact our tax expense. Our net income for the period was 13 million, a notable improvement from the net loss of 3.6 billion recorded in Q3 2023. Earnings per share for the quarter was two or $0.03 compared to a loss of $9.53 per share in the same period last year. We ended the quarter with cash and investments totaling $9.2 billion, down from 10.8 billion at the end of Q2, primarily due to ongoing research and development expenses and operating activities. Moving to slide 16, I want to provide additional details on the cost reductions we are driving across the Company. As discussed on previous calls, as a platform company, we are building a unique operating model. And over the last few years, we have invested purposefully into people, processes and technologies to build foundational capabilities that will allow us to scale efficiently. We continue to see these efficiency gains in our 2024 results. As mentioned on the previous slide, we reduced 3Q SG&A expenses, but by 36% year over year, we had year-over-year reductions across all areas of our SG&A categories, commercial, medical and G&A, functional seven. There major drivers were from reduction in purchase services and external consultants as we better leverage digital technology and AI. Year-to-date, our SG&A spending is down 24% year over year. While we continue to drive productivity improvements, we are also committed to increasing COVID-19 vaccination rates with investment in HCP. education and consumer and ad campaigns as well as increasing our COVID-19 and RSV market share in competitive markets. Therefore, we don't expect as large a year over year decline in for Q2 SG&A spending versus the prior year. For the full year, we expect SG&A to be down approximately 20% to 1.2 billion, which is reflected in our financial framework update on the next slide, turning to that 2020 for financial framework on Slide 17. Our net product sales guidance remains at three to 3.5 billion. As reviewed earlier, there are a handful of factors we are monitoring as the season progresses for cost of sales. We are narrowing our guidance at 40% to 45% of product sales as a result of the continued manufacturing productivity improvements we are driving in the Company. For R&D. We are lowering our full-year estimate of 4.6 to 4.7 million from our previous guidance of $4.8 billion. The reduction is due to cost savings from productivity improvements as well as clinical study timing for SG&A, we continue to expect full-year expenses to be approximately 1.2 billion, down from 1.5 billion in 2023, a decrease of approximately 20% year over year. We continue to expect taxes to be negligible in 2024, and we are updating our capital expenditures outlook to approximately 1.2 billion, which reflects the purchase of our Norwood campus from our landlord for approximately $400 million, partially offset by approximately 100 million of other CapEx reductions. The purchase of this highly strategic asset allows us full control to expand and build out the campus to drive future productivity and innovation. We anticipate this transaction will close in December. We can continue to expect ending 2024 was approximately 9 billion of cash and investments. The additional cash outlay for purchasing our Norwood campus will be offset by reductions in our cost of sales, R&D and other capital expenditures. Based on our 3Q actual product sales $1.8 billion. We have strong visibility into our expected cash collection timing from our customers in 4Q. With that, I will now hand the call over to Stephen.

感謝您的電話，大家好。今天，我將概述我們第三季度的財務業績，並分享我們對2024 年剩餘時間的展望。我們的淨收入產品銷售額為 18 億美元，使年初至今的產品銷售額達到 220 萬件。年初至今，我們也從贈款、合作、授權和特許權使用費中獲得了約1 億美元的其他收入（未包含在本投影片的數據中），其中2020 年第三季的12 億美元來自美國市場的產品銷售，我們在美國市場的產品銷售收入為12 億美元。季度之間的銷售時間，但我們更新的COVID-19 疫苗比去年提前三週獲得FDA 批准。我們在美國的 12 億銷售額中還包括約 1.4 億美元的撥備發放，這主要是由於 2023 年和 2024 年季節的產品回報低於我們先前的估計。此外，我們在第三季開始銷售 RSV 疫苗，而 HIFU 的銷售僅限於 1000 萬劑，我們相信隨著時間的推移，我們努力爭取更大的市場份額，有長期增長的潛力。國際銷售額為6 億美元，符合我們對2023 年同期較低的預期，當時銷售額受益於2022 年推遲的季度的完成。美元，這意味著4Q產品銷售區間為0.8至13億。我們預計我們的美國第四季產品銷售額將在 205 億美元之間，其驅動因素如下。三個關鍵變數是我們的市場份額，目前零售業的市佔率約為 40%。目前，根據政府對市場規模的下一個疫苗接種率安排，判斷年底的份額還為時過早，因為新冠疫苗接種量較前一年持平至下降 10%。最後，我們在 2024 年 RCV 市場的表現和最終規模。 RSV 銷售量也沒有上升。我們預計將處於銷售範圍的低端。我們預計我們國際福特的新產品銷售量在608億之間。我們的國際銷售範圍較窄，因為大部分銷售都是合約數量和已確認的訂單。最終的國際銷售額將取決於收入確認、時間安排以及我們在一些特定市場的表現。轉到投影片 15，我將討論我們第三季的財務結果，其中包含更多細節。第三季產品淨銷售額為 18 億美元。正如我剛剛在上一頁討論的那樣，我們 20 年第三季的銷售成本佔該季度產品淨銷售額的 28%。與2023 年第三季的22 億美元相比，我們的銷售成本年減了77%。中記錄了14 億美元的費用。除去 14 億美元的費用，隨著我們繼續取得進展，推動製造業務的生產力進一步提高，銷售成本仍較去年同期成長 13%。 2024 年第三季研發費用為 11 億美元，較去年同期的 12 億美元下降 2%。我們在 2024 年第三季購買了優先審核券，該券已包含在我們第三季的業績中。不包括 PRV 的採購，隨著我們繼續提高組織所有領域的成本效率，我們在研究開發和臨床製造方面的支出比去年同期大幅下降。 2024 年第三季的銷售、管理和行政費用為 2.81 億美元，年減 36%。這一下降反映出我們專注於提高成本效率和進行有針對性的投資，以繼續增強我們的整體生產力。我將在下面的幻燈片中提供更多詳細資訊。第三季我們確認了所得稅800萬，比去年同期的17億大幅減少。減少的主要原因是 2023 年第三季針對遞延所得稅資產設立了 17 億美元的估價備抵。我們該季度的淨利潤為1,300 萬美元，比2023 年第三季錄得的36 億美元淨虧損顯著改善。 。本季結束時，我們的現金和投資總額為 92 億美元，低於第二季末的 108 億美元，主要是由於持續的研發費用和營運活動。前往投影片 16，我想提供有關我們在整個公司推動的成本削減的更多詳細資訊。正如之前的電話會議中所討論的，作為一家平台公司，我們正在建立獨特的營運模式。在過去的幾年裡，我們有目的地投資於人員、流程和技術，以建立基礎能力，使我們能夠有效地擴展規模。我們在 2024 年的業績中繼續看到這些效率提升。如上一張投影片中所提到的，我們減少了第三季的 SG&A 費用，但比去年同期下降了 36%，我們的 SG&A 類別（商業、醫療和 G&A、職能七）的所有領域都同比減少。主要驅動因素是隨著我們更好地利用數位技術和人工智慧，採購服務和外部顧問的減少。年初至今，我們的 SG&A 支出年減 24%。在我們繼續推動生產力提高的同時，我們也致力於透過對 HCP 的投資來提高 COVID-19 疫苗接種率。教育、消費者和廣告活動，以及增加我們在競爭市場中的 COVID-19 和 RSV 市場份額。因此，我們預計第二季的銷售、管理及行政費用支出與前一年相比不會出現如此大的年減。對於全年，我們預計SG&A 將下降約20% 至12 億，這反映在我們下一張幻燈片的財務框架更新中，轉向幻燈片17 上的2020 年財務框架。 3至35億。如前所述，隨著季節的進展，我們正在監控一些銷售成本因素。由於我們不斷推動公司製造生產力的提高，我們將產品銷售額的指導範圍縮小到 40% 至 45%。用於研發。我們將全年預期從 4.6 億美元下調至 470 億美元，先前的指引值為 48 億美元。這一減少是由於生產力提高以及 SG&A 臨床研究時間安排帶來的成本節省，我們繼續預計全年費用約為 12 億美元，低於 2023 年的 15 億美元，年減約 20%。我們仍然預計2024 年的稅收可以忽略不計，並且我們將資本支出前景更新為約12 億美元，這反映了我們以約4 億美元的價格從房東手中購買了我們的諾伍德園區，部分被約1億美元的其他資本支出削減所抵銷。購買這高度策略性的資產使我們能夠完全控制擴建和建造園區，以推動未來的生產力和創新。我們預計交易將於 12 月完成。我們可以繼續預計到 2024 年底將有約 90 億現金和投資。購買諾伍德園區的額外現金支出將被銷售、研發和其他資本支出成本的減少所抵銷。根據我們第三季的實際產品銷售額 18 億美元。我們對第四季客戶的預期現金收款時間有很強的了解。現在，我將把電話轉交給史蒂芬。

Thank you, Jamie, and good morning or good afternoon, everyone. Today, I'll do a quick review of our pipelines and R & D event. In September, we discussed our focus on 10 product approvals over the next three years. Today, I'll briefly summarize the status of those programs, starting with our respiratory vaccine portfolio for our next generation COVID vaccine mRNA 23, we are pleased with the positive Phase three safety, immunogenicity and vaccine efficacy data we presented in R & D debt, including a 13.5% higher vaccine efficacy compared despite Thanks in participants age 65 and older in that study. As previously shared, we intend to file mRNA to probably three for approval in 2024 and will use a priority review voucher for our RSV vaccine, mRNA 1345, and we also shared positive safety and immunogenicity data from our Phase three trial in participants, 1859 years old, who are high risk from our IC. We are also using a priority review voucher for this program, which we intend to submit this year. We also shared positive Phase three data from our combination through COVID vaccine, mRNA 1083 and intend to file for approval in 2024. Subject to ongoing discussions with FDA, we have decided not to use a priority review voucher for this program. Given the timing of submission and the potential launch relative to the respiratory viruses in 2025, we will announce could do for dates for these programs if and when they are confirmed by the FDA. Moving now to our standalone flu program, mRNA 1010, we have initiated in substantially enrolled the first season of our Phase three vaccine efficacy study. As a reminder, this Phase three study is funded within our project financing agreements with Blackstone Life Sciences. Slide 20 shows the study design for that Phase three standalone include actually this is a randomized observer, blind active control study. Compare it is designed to be enrolled over two seasons for the study has the possibility to declare early success after a single season. Now turning to our non respiratory portfolio, starting with our Leighton and other buyers exits for our CMV vaccine, we continue to expect that we will improve the 81 cases required for the interim analysis in our Phase three study by the end of this year. Following the accrual of these cases, the Data Safety Monitoring Board, we will conduct a statistical analysis, should they recommend unblinding. At the interim analysis, we will share those results for norovirus. I'm happy to announce that we are rapidly enrolling our Phase three trial in a moment. I will take you through the study design of that norovirus Phase three study in oncology, we and our partner, Merck, have initiated a Phase three trial evaluating edge of NINT. Grand Marnier 41 cities, seven in combination with Keytruda after neoadjuvant, Keytruda and chemotherapy in patients with certain types of percentage non-small cell lung cancer. This is the second Phase three trial for INT. in non-small cell lung cancer and is targeting patients who may not respond to new adjuvant therapy alone. I'll also review this study certain design in the upcoming slides for our rare disease therapeutics. We intend to begin to generate pivotal trial data for our PA program in 2024. And for M&A, we have an agreement with FDA on our pivotal trial design. We now expect to start that study in the first half of 2025. On Slide 22 is the design of our Phase three study for our norovirus vaccine candidate. As a reminder, norovirus is a gastrointestinal disease with high unmet need and no approved vaccines on the market. The Phase three study design test, the efficacy, safety and immunogenicity of our vaccine in 25,000 adults age 18 and older, randomized one to one observer blind and placebo control. Turning now to the trial design for our second Phase three study in non-small cell lung cancer for INT. in collaboration with Merck, which complements the Phase three interim CFO to trial this Phase three study called interim past oh nine, we will enroll more than 1,200 patients with Stage two to three the non-small cell lung cancer without an EGFR mutation and who are able to undergo surgery. These patients will receive neoadjuvant therapy for Keytruda plus chemotherapy, followed by surgery following surgery. The study will randomize approximately 680 patients who have not achieved a pathologic complete response in the two arms combination of INT. plus Keytruda or Keytruda plus placebo. The primary endpoint for this study is disease free survival and secondary endpoints include distant metastasis, free survival and overall survival. With that, I will now turn the call back over to Stefan.

謝謝傑米，大家早安或下午好。今天，我將快速回顧我們的管道和研發活動。 9 月份，我們討論了未來三年重點關注的 10 種產品的批准。今天，我將簡要總結這些項目的狀況，從我們下一代新冠疫苗mRNA 23 的呼吸道疫苗組合開始，我們對我們在研發債務中提供的積極的第三階段安全性、免疫原性和疫苗功效數據感到滿意，其中包括與該研究中 65 歲及以上參與者相比，儘管感謝，疫苗功效仍高出 13.5%。正如之前分享的那樣，我們打算在2024 年將mRNA 提交給大約三個國家進行批准，並將使用我們的RSV 疫苗mRNA 1345 的優先審查憑證，我們還分享了來自1859 年參與者的第三階段試驗的積極安全性和免疫原性數據老年人，是我們 IC 的高風險族群。我們也對該計劃使用優先審查憑證，我們打算今年提交。我們也分享了我們透過新冠疫苗 mRNA 1083 進行組合的第三階段積極數據，並打算在 2024 年申請批准。考慮到與呼吸道病毒相關的提交時間和可能在 2025 年啟動的情況，如果 FDA 確認這些項目，我們將宣布這些項目的具體日期。現在轉向我們的獨立流感計畫 mRNA 1010，我們已開始大量招募第三階段疫苗效力研究的第一季。提醒一下，這項第三階段研究是由我們與 Blackstone Life Sciences 簽訂的專案融資協議資助的。投影片 20 顯示了第三階段獨立的研究設計，實際上這是一項隨機觀察者、盲主動對照研究。比較它的設計是在兩個賽季中進行，因為研究有可能在一個賽季後宣布早期成功。現在轉向我們的非呼吸產品組合，從我們的 Leighton 和其他買家退出我們的 CMV 疫苗開始，我們繼續預計到今年年底我們將改善第三階段研究中中期分析所需的 81 例病例。在收集這些案例後，資料安全監測委員會將進行統計分析，如果他們建議揭盲的話。在中期分析中，我們將分享諾羅病毒的這些結果。我很高興地宣布，我們正在迅速進行第三階段試驗。我將帶您了解諾羅病毒腫瘤學第三階段研究的研究設計，我們和我們的合作夥伴默克公司已經啟動了評估 NINT 優勢的第三階段試驗。 Grand Marnier 41個城市中，有7個在新輔助、Keytruda和化療後與Keytruda合併治療某些類型的非小細胞肺癌患者。這是 INT 的第二個三期試驗。在非小細胞肺癌中，目標是那些可能對單獨新輔助治療沒有反應的患者。我還將在接下來的幻燈片中回顧這項研究的某些設計，以用於我們的罕見疾病治療。我們打算在 2024 年開始為我們的 PA 專案產生關鍵試驗數據。我們現在預計在 2025 年上半年開始這項研究。提醒一下，諾羅病毒是一種胃腸道疾病，需求未被滿足，市場上還沒有批准的疫苗。第三階段研究設計在 25,000 名 18 歲及以上成年人中測試了我們疫苗的功效、安全性和免疫原性，隨機一對一觀察者盲法和安慰劑對照。現在轉向 INT 針對非小細胞肺癌的第二項三期研究的試驗設計。默沙東與默克公司合作，對第三階段臨時財務長進行補充，以試驗這項名為「9 年後臨時」的第三階段研究，我們將招募超過1,200 名患有二至三期非小細胞肺癌且無EGFR 突變的患者，這些患者能夠接受手術。這些患者將接受 Keytruda 新輔助治療加化療，然後進行手術。研究將隨機分組約 680 名在 INT 兩組組合中尚未達到病理完全緩解的患者。加 Keytruda 或 Keytruda 加安慰劑。本研究的主要終點是無疾病存活期，次要終點包括遠端轉移、無疾病存活期和總存活期。這樣，我現在將把電話轉回給斯特凡。

Thank you, Stephen and Jamie. During R&D Day in September, we feel the Company priorities priority one to drive sales of approved products, Starbucks in Namibia property to focus on our late-stage pipeline, where we believe we can have up to 10 product approvals over the next four years. So we should be drivers of sales growth, priority free to deliver cost efficiencies across the business and slower pace of all the investments, reducing annualized expenses by EUR1.1 billion, something equivalent 27, of course, properties in rough terms of buybacks and M&A. Yes, which we believe the foundation of our respiratory vaccine portfolio. We will continue to work with all market channels to maximize production availability. We are focusing on marketing and medical education to trying to drive with COVID. Vaccination rate goes up a vessel through over time. Internationally. We're glad to Greek manufacturing plants online in the UK in Canada and Australia in 2025 M. 8,000 for accretive multi-year contract in those countries, and we foresee them advisory contracting in the U.S. And I look at for the 2025, we expect to increase Elementia segment market share. We are focused on a range of five to 10 product approvals over the next three years, which we will improve our sales growth and size of the next wave of 5G business. For eight of these programs, we have near-term milestones for CMV. We expect with rigor of the interim analysis for Phase three efficacy study by the end of this year. We're looking at for what those results for PNM. I mean, we plan to initiate pivotal studies on nobody else and through pretty scary vaccine efficacy studies are now underway. Finally, we schedule five as we progress into April for an exit COVID vaccine for RSV vaccine for high-risk 18 with net yields and load competition. Covid productivity. Subject to ongoing discussion with the U.S. FDA, we will continue to focus on improving efficiency by the federal R&D and SG&A expenses flat to down in 2025. And as demonstrated in the quarter, we're making progress on our cost saving initiatives already by 2027, we expect to decrease and your R&D expenses by BRL1.1 billion on the cost of sales will continue to drive efficiency, and we expect to achieve more proactive in the acreage that we were flagging. A framework we showed previously. We have some products improved, definitely protect people every day. We have a long business pipeline for medium and the Company and will continue to focus on data of aggressiveness, placebo impact to portfolio management suite, where we work to be done to meet our existing ships. August and Continental team will be able to achieve our goals and cause it to be excited about the potential we have to deliver for patients. The actions we are we are taking 200 people is becoming a reality with these are products that would be happy to take questions.

謝謝你們，史蒂芬和傑米。在9 月的研發日期間，我們認為公司的首要任務是推動已批准產品的銷售，納米比亞星巴克地產將重點放在我們的後期管道上，我們相信在未來四年內我們可以獲得多達10 個產品批准。因此，我們應該成為銷售成長的驅動力，優先考慮整個業務的成本效率，並放慢所有投資的步伐，減少年化費用11 億歐元，當然，粗略地講，這相當於27 處房產的回購和併購。是的，我們相信這是我們呼吸道疫苗產品組合的基礎。我們將繼續與所有市場通路合作，以最大限度地提高生產可用性。我們專注於行銷和醫學教育，以嘗試應對新冠病毒。隨著時間的推移，疫苗接種率會上升。國際上。我們很高興希臘製造工廠在英國、加拿大和澳大利亞於 2025 年上線 M. 8,000，以在這些國家增加多年期合同，我們預計他們將在美國簽訂諮詢合同。份額。未來三年我們的重點是獲得 5 到 10 個產品批准，這將提高我們的銷售成長和下一波 5G 業務的規模。對於其中八個項目，我們為 CMV 設定了近期里程碑。我們預計三期療效研究的中期分析將在今年底前完成。我們正在尋找 PNM 的結果。我的意思是，我們計劃對其他人進行關鍵研究，並且目前正在進行相當可怕的疫苗效力研究。最後，隨著進入 4 月份，我們計劃推出 5 項針對高風險 18 種疫苗的退出 COVID 疫苗和 RSV 疫苗，並進行淨收益和負荷競爭。新冠生產力。根據與美國FDA 的持續討論，我們將繼續致力於提高效率，到2025 年，聯邦研發和銷售、一般管理費用將持平至下降。已取得進展，我們預計銷售成本將減少 11 億雷亞爾的研發費用，這將繼續提高效率，並且我們預計在我們所標記的面積上實現更加積極主動。我們之前展示過的一個框架。我們改進了一些產品，絕對可以保護人們的每一天。我們對中型和公司有很長的業務管道，並將繼續專注於積極性數據、安慰劑對投資組合管理套件的影響，我們將在這些方面努力滿足我們現有船舶的需求。 August 和大陸集團團隊將能夠實現我們的目標，並使其對我們為患者提供的潛力感到興奮。我們正在為 200 人採取的行動正在成為現實，這些產品很樂意回答問題。

Thank you. Ladies and gentlemen, if you have a question or comment at this time, please press star one on your telephone. If your question has been answered, you may remove yourself from the queue, please press star one. Again. We'll pause for a moment while we compile the Q&A roster. My first question comes from Salveen Richter with Goldman Sachs. Your line is open.

謝謝。女士們、先生們，如果您此時有任何疑問或意見，請按電話上的一號星星。如果您的問題已得到解答，您可以將自己從佇列中刪除，請按星號一。再次。我們將暫停片刻，整理問答名單。我的第一個問題來自高盛的 Salveen Richter。您的線路已開通。

Thanks and good morning. And two questions for me. one is can you speak to the source of the rest of world revenue generated in the third quarter and expected in Q4 with regard to which continues our constituting hands on them, these contracts that you should you expect them to recur in 2025? And then separately on we see And moving on, you talked about both the US and two on your share, the results of the DSMB recommended unblinding. Can you speak more to them as to whether we will actually get interim data provided to us or we're going to have to wait for the full analysis? Thank you.

謝謝，早安。還有兩個問題想問我。一是您能否談談第三季度產生的世界其他地區收入的來源以及第四季度預計的收入來源，我們將繼續持有這些合同，您是否希望它們在 2025 年再次簽訂這些合同？然後我們分別看到，繼續前進，您談到了美國和您的分享中的兩個內容，DSMB 建議揭盲的結果。您能否與他們詳細談談我們是否會真正獲得向我們提供的臨時數據，還是我們將不得不等待完整的分析？謝謝。

Sure. Thanks for that question, Salveen. I'll take the first one in terms of rest of world revenues. So without getting into too much specifics, I think you know, we're establishing a presence in the United Kingdom in Calgary, Canada and Australia. We announced an order in Brazil. And so that's been the balance will be shipped either in the third quarter in the fourth quarter. And when we look at the fourth quarter of the 600 million on the low end of the large majority of that is contracted with those countries and others. But I just wanted to name a few. As we look to 2025, I think as we mentioned at R&D Day, that there will be a decline in some of those countries. And then it will then uptick or anticipate any safety on the contracts that we have in certain countries. So that is available on the rest of world split. And on the CMV question down to that, if the DSMB recommended unblinding to sponsor at the first interim analysis to your question, that would be because we met the criteria for vaccine efficacy and obviously we would share those results around if we receive them, there is a chance that the DSMB will not recommend unwinding and which would mean perhaps that we did not meet statistical significance in that first interim analysis and the Going then to the final analysis, which could happen quite quickly and depending upon the conditions with that communications and the timing of that final analysis, we may or may not be communicating Ray-Ban about that. We are waiting for that final analysis. But we would in any event if the DSMB recommended unblinding share business results.

當然。謝謝你提出這個問題，薩爾文。我將根據世界其他地區的收入來選擇第一個。因此，無需透露太多細節，我想您知道，我們正在英國卡加利、加拿大和澳洲建立業務。我們宣布了巴西的訂單。因此，餘額將在第三季或第四季出貨。當我們觀察第四季 6 億美元的低端時，其中大部分是與這些國家和其他國家簽訂的合約。但我只想舉幾個例子。當我們展望 2025 年時，我認為正如我們在研發日所提到的那樣，其中一些國家的銷售將會下降。然後它會增加或預測我們在某些​​國家/地區的合約的任何安全性。所以這在世界其他地區是可用的。關於CMV 問題，如果DSMB 建議在對您的問題進行第一次中期分析時對贊助商進行揭盲，那是因為我們符合疫苗功效的標準，顯然，如果我們收到這些結果，我們會分享這些結果，那裡DSMB 有可能不建議放鬆，這可能意味著我們在第一次中期分析和隨後的最終分析中沒有達到統計顯著性，這可能會很快發生，具體取決於通信條件和最終分析的時間，我們可能會也可能不會與雷朋就此進行溝通。我們正在等待最終的分析。但無論如何，如果 DSMB 建議公開分享業務結果，我們都會這麼做。

Thank you. Our next question comes from Ellie Merle with UBS. Your line is open.

謝謝。我們的下一個問題來自瑞銀集團的埃莉梅爾。您的線路已開通。

Thanks for taking the question. And just another one on how to think about our kiosk covenant revenues on. In the past, you've talked about some contracts with some countries for guaranteed pension funds like come in and Dropbox under the tuck-ins. Maybe can you just in broad channel to characterize this Pfizer's from Inderes, our contracts that you have outstanding Axiare from the Thailand floods essentially guaranteed from a revenue perspective here arm in terms of some ideas of swap contracts? Or has it will have a sense of maybe like what the minimum standard of excellence can be arm? And secondly, there's time to time based on that. And then just a second follow-up on CME DR. I think you alluded to this in the last answer, but maybe just in terms of the like Lee of accruals, I guess what's your latest expectation in terms of timeframe between when you are accruing a number of events to trigger the interim versus the number of events to trigger the final analysis? The timing between as Tino. Okay.

感謝您提出問題。這是關於如何考慮我們的資訊亭契約收入的另一項內容。過去，您談到與一些國家/地區簽訂的一些有保障的退休基金合同，例如 come in 和 Dropbox under the tuck-ins。也許您可以在廣泛的渠道中描述一下來自Inderes 的輝瑞公司的合同，您在泰國洪水中擁有未償還的Axiare 合同，從收入角度來看，從互換合同的一些想法來看，基本上得到了保證？或者它是否會有一種感覺，也許就像手臂的最低卓越標準一樣？其次，有時也會基於此。然後是 CME DR 的第二次後續行動。我認為您在上一個答案中提到了這一點，但也許只是就應計費用之類的李而言，我想您在累積許多事件以觸發臨時事件與觸發臨時事件的數量之間的時間範圍方面的最新期望是什麼事件觸發最終分析？作為蒂諾之間的時間安排。好的。

Yes, sure. So I'll take the first Bardelli. So in terms of the contracts that we have, it with some of these countries are not going to disclose the specifics. But what I will say is that as we add products over time, you can imagine that the amount of the minimum purchase commitment will grow over time. So that's why, as I just mentioned in my prior response, that it will drop in 2025 and then start to grow in 2026.

是的，當然。所以我會選第一個巴代利。因此，就我們與其中一些國家簽訂的合約而言，它不會透露具體細節。但我要說的是，隨著我們隨著時間的推移添加產品，您可以想像最低購買承諾的金額會隨著時間的推移而增長。這就是為什麼，正如我剛才在先前的回覆中提到的，它會在 2025 年下降，然後在 2026 年開始成長。

But I don't think we're going to disclose anything more than that. Some of the question on CMV and the timing of kit to grow, and it is coming quite steadily in right now. And in fact, we do have a bit of a backlog of case confirmation that we are working through them. There's multiple steps that have to go with multiple testing to validate the case. And and so we actually I obviously don't control the rate of case accrual on, but we do expect operative. And if we are doing that final analysis, that it won't be a very long period of time between actually could happen quite quickly.

但我認為我們不會透露更多的內容。關於 CMV 的一些問題以及試劑盒生長的時間，它現在正在穩定地出現。事實上，我們確實有一些積壓的案件確認，我們正在解決這些問題。必須執行多個步驟並進行多次測試才能驗證案例。因此，我們實際上顯然無法控制案件應計率，但我們確實期望有效。如果我們進行最終分析，那麼這之間的時間不會很長，實際上可能會很快發生。

Okay, thanks.

好的，謝謝。

Next question comes from Gena Wang with Barclays. Your line is open.

下一個問題來自巴克萊銀行的 Gena Wang。您的線路已開通。

Thank you. I have two questions. one is regarding the commercial questions. On the. If we calculate 1.2 billion U.S. revenue and accumulate 19 million U.S. doses is the cancellation like $63 per dose as a net price in the right way to think about it? And then regarding the reserve return, could you provide a final we just returned from last winter season and what is your reserve return so far for this winter season? And I quickly regarding absolute combo, absolute CO2 Campbell and not using power value chain and maybe give us a little bit more rationale for this. And I will also be that you submitted here. How many of these will make for 2025 winter season?

謝謝。我有兩個問題。一是關於商業問題。上。如果我們計算 12 億美國收入並累積 1,900 萬劑美國疫苗，那麼取消每劑 63 美元的淨價是否正確？然後關於儲備回報，您能否提供我們剛從去年冬季返回的決賽，以及到目前為止，您今年冬季的儲備回報是多少？我很快就談到了絕對組合、絕對二氧化碳坎貝爾以及不使用電力價值鏈，也許會給我們更多的理由。而我也將你提交到這裡。其中有多少可以用於 2025 年冬季？

Yes. Maybe I'll take the first question. So on the US pricing, the 19 million, I think, is the total market you might be referring to. And for COVID vaccinations, not specific to the data. That said that the pricing that you're talking about, we won't specifically this close, but it's not that far off

是的。也許我會回答第一個問題。因此，就美國定價而言，我認為 1900 萬是您可能指的整個市場。對於新冠疫苗接種，沒有具體的數據。也就是說，你所說的定價，我們不會特別接近，但也不是那麼遙遠

come on the pipeline. Question to you, and thank you for both on. So first on the priority review voucher for the flu COVID combo, given where we are in terms of timing of this year and relative timing of the contracting season for flu vaccines. And we no longer think it makes sense to use a priority review voucher dry and accelerate that process for. But ultimately, we believe we would miss the contracting season for that region will hold back that PRB and use it for different products in the future. And as far as the submissions and as we confirm today, we are expecting to the other two submissions to go forward with priority review vouchers. And given the timelines on, you can understand that we think that means approval next year, is it possible and can happen prior to the season. However, now we do not include any revenue from either the 18 to 59 RSVSBLA. or 1283 in our 2025 guidance or expectations. And so if we were able to deliver those with appropriate view center rub, we still wouldn't include any revenue that would be an upside

來吧。向您提出問題，謝謝您。首先是流感疫苗組合的優先審查憑證，考慮到我們今年的時間安排以及流感疫苗發病季節的相對時間安排。我們不再認為使用優先審查憑證來加速這個過程是沒有意義的。但最終，我們相信我們會錯過該地區的合約季節，這將阻礙 PRB 並在未來將其用於不同的產品。就提交的內容而言，正如我們今天確認的那樣，我們預計其他兩份提交的內容將獲得優先審查憑證。考慮到時間表，你可以理解我們認為這意味著明年的批准，是否有可能並且可以在賽季之前發生。然而，現在我們不包括來自 18 至 59 RSVSBLA 的任何收入。或我們 2025 年指導或預期中的 1283。因此，如果我們能夠提供具有適當視圖中心摩擦的內容，我們仍然不會包含任何有利的收入

reserve returns. So can you repeat the question? Gena, if I missed this in our return profile that

儲備回報。那你能重複一下這個問題嗎？ Gena，如果我在我們的退貨資料中錯過了這一點

you've shown reserve return is, could you provide a final reserve return from last winter season? Because I know you initially booked five over 500 million into adjustment to see the final numbers. So if you could provide the final numbers and what is your reserve risk return assumption so far for this when incision?

您已經展現了儲備回報，您能提供去年冬季的最終儲備回報嗎？因為我知道你們最初預訂了五億多的調整來看看最終的數字。那麼，如果您可以提供最終數字，那麼到目前為止，您在切開時的儲備風險回報假設是多少？

Yes. So Lam to, as I mentioned in my prepared remarks that we released in the quarter about $140 million, primarily driven from a returns reserves being lower than our prior estimate, stood at five 100 plus went down to, let's say, $400 million for the prior season. So we learned from that and continue to forecast what an anticipated products with returns reserve is for this season, and we will continue to monitor it as we look at vaccination rates throughout the entire quarter and what we projected into the first quarter of next year. Okay.

是的。因此，正如我在準備好的發言中提到的，我們在本季度發布了約1.4 億美元，主要是由於回報準備金低於我們之前的估計，在5 百多美元的情況下，我們可以說是4 億美元。因此，我們從中吸取了教訓，並繼續預測本季度有回報儲備的預期產品，並且我們將繼續對其進行監控，同時我們將關注整個季度的疫苗接種率以及我們對明年第一季的預測。好的。

Our next question comes from Michael Yee with Jefferies. Your line is open.

我們的下一個問題來自 Jefferies 的 Michael Yee。您的線路已開通。

Thank you. Questions, not 10, but on the combo, I know that you say you're in discussions with the FDA. Can you just clarify what are the different factors that are contributing to wine? You have lack of confidence on filing or I guess not certainty on filing the combo, for example, would there be an infection today that to be run a little unclear to us on the combo? And then on RSV., I think the market anticipated dishwash can be a big market. However, RBSE, there are a lot, in fact, dynamics going on there. And maybe comment on whether you think there will be a change to this market and what we gave you confidence that you're going to actually be a player here, given you've already given, I guess, given your competition now and where your guidance is for. Mike, I think you will

謝謝。問題不是 10 個，而是關於組合，我知道你說你正在與 FDA 進行討論。您能澄清一下影響葡萄酒的不同因素有哪些嗎？您對提交缺乏信心，或者我想對提交組合不確定，例如，今天是否會出現感染，而我們對組合的運作有點不清楚？然後就RSV而言，我認為市場預期的洗碗機會是一個很大的市場。然而，對於 RBSE，事實上，那裡正在發生很多動態。也許可以評論一下您是否認為這個市場會發生變化，以及我們給您帶來的信心，您將真正成為這裡的參與者，鑑於您已經給出了，我想，考慮到您現在的競爭以及您在哪裡指導是為了。麥克，我想你會的

thank you for both questions come. So first on the I'll take the Congo and even higher. So first, we are in discussions with the Aviva data for 1083, as you remember, teams or middle of this year. And so we've only more recently had the opportunity to be sharing that and engaged in discussions about what would be in the the BLA for accelerated approval of candy three. Based on the immunogenicity results, I would I would not comment on those discussions back and forth. We continue to work closely with the agency to understand what they would like to see in that we continue to believe, as we said today, that we will be submitting for approval this year. Although those conversations are ongoing and we'll update as they proceed forward. And the decision not to use the priority review voucher, which became wondering about the timing of that approval. And ultimately, our view that from that would that we would miss the contracting season for influenza and therefore didn't make sense to do that. But by withdrawing priority review voucher, we also allow for a more for some time for review, which is also obviously the benefit of ourselves and the agency. Ken,

謝謝你的兩個問題。所以首先我會選擇剛果甚至更高。首先，我們正在討論 Aviva 的 1083 個數據，如您所知，團隊或今年年中的數據。因此，我們最近才有機會分享這一點，並參與討論 BLA 中的內容，以加快糖果三號的批准。根據免疫原性結果，我不會對這些討論進行評論。我們將繼續與該機構密切合作，以了解他們希望看到什麼，正如我們今天所說，我們仍然相信我們將在今年提交批准。儘管這些對話正在進行中，我們將在進展過程中進行更新。以及不使用優先審查憑證的決定，這讓人們對批准的時間感到好奇。最終，我們認為，這樣我們就會錯過流感的發病季節，因此這樣做是沒有意義的。但透過撤回優先審查憑證，我們也多了一段時間進行審查，這顯然對我們自己和機構都有好處。肯，

on the ISV, Mike, I think there's a few things. As you know, the market has been much lower than last year and much more willing to participate in are obviously the new CDC guidelines that came out in the June timeframe impacted that you have a piece we are hearing from customers. You have that refocus on making sure people get David it through vaccination right now. So these would be quite interesting to see what happens in Q1 potentially. And thus, the shape of the curve of IV looks different than what we saw in the produce season. So that's that's to be seen. The other piece is because through contracting and because of what happened last year and as new contracting happened before the CDC guidelines, there's quite some of our volume in the channel, whether book by the retailers themselves and in was barrels. And so of course, we've had much lower market and there's a lot of inventory in the customers had both was seller and we can from a CT scan matching is taking quite some time to go through that. The inventory, right? And so we think that there's an interesting question about the market dynamics in terms of timing. Again, with Q1 being more important climbing, 5G will fall into question to be seen. Of course, we expect U.S. mall-based accumulate. Cvt will cause you to review and look at what's the right guidelines with us forever for because we do have to decide and being a bit of a burden to the new contract COVID NOC at the same time for foresee them, we believe is going to have an impact in the US and you have a piece of Mexico's remodeling off these outside the US, which does you know, we are not held outside the US. We are getting approvals and Nagano to continue to happen in the months to come. So we believe 25 and beyond should also help us five years.

關於 ISV，Mike，我認為有幾件事。如您所知，市場比去年低得多，並且更願意參與，顯然是 6 月發布的新的 CDC 指南影響了我們從客戶那裡聽到的消息。你必須重新專注於確保人們現在就透過疫苗接種感染大衛。因此，看看第一季可能發生的情況將會非常有趣。因此，IV 曲線的形狀看起來與我們在農產品季節看到的不同。這就是有待觀察的。另一部分是因為透過合同，由於去年發生的事情，以及新的合同發生在疾病預防控制中心指導方針之前，我們的渠道中有相當多的銷量，無論是零售商自己預訂的還是桶裝的。當然，我們的市場要低得多，而且客戶中有很多庫存，他們都是賣家，我們可以從 CT 掃描匹配中看出，這需要相當長的時間才能完成。庫存吧？因此，我們認為在時間方面存在一個關於市場動態的有趣問題。再次，隨著第一季的重要性不斷攀升，5G 是否會陷入質疑有待觀察。當然，我們預計以美國購物中心為基礎的累積。 Cvt 將使您永遠審查並了解什麼是我們的正確指導方針，因為我們確實必須做出決定，同時為新合約 COVID NOC 帶來一些負擔，因為我們相信它們將會有這對美國產生了影響，墨西哥在美國以外的地區也有一些改造，你知道嗎，我們不在美國以外的地方。我們正在獲得批准，長野將在未來幾個月繼續進行。因此，我們相信 25 歲及以上也應該對我們有五年的幫助。

Thank you.

謝謝。

Our next question comes from Tyler Van Buren with TD. Cowen. Your line is open.

我們的下一個問題來自 TD 的泰勒·範布倫 (Tyler Van Buren)。考恩.您的線路已開通。

Hey, guys, good morning. Thanks very much for taking the questions. So I wanted to ask about US COVID vaccine sales. So that were roughly flat quarter over quarter between Q3 and Q4 last year. With the vaccine until guidance for Q4 this year assumes a decline as much as 60% to 80% quarter over quarter of our US results remain low and my math is correct. So is there a significant shift occurring this year to vaccines being available earlier, patients getting vaccinated earlier that you expect to be the dynamic moving forward? Or could this guidance be conservative? I just ask because it's pretty dramatic change in the cadence of U.S. sales. So any additional color would be appreciated. Thank you.

嘿，夥計們，早安。非常感謝您提出問題。所以我想問美國新冠疫苗的銷售情況。因此，去年第三季和第四季之間的季度環比大致持平。就疫苗而言，直到今年第四季的指導意見假設我們美國的季度環比下降高達 60% 至 80% 的結果仍然很低，我的數學是正確的。那麼，今年是否出現了重大轉變，即疫苗更早上市、患者更早接種疫苗，您預計這將成為未來的動力？或者這個指導可能是保守的？我之所以這麼問，是因為美國的銷售節奏發生了相當大的變化。因此任何額外的顏色將不勝感激。謝謝。

So if you think about the US market, I think what is important for us is to look at the different channels because we are very few fronts. As we've shared the data that we have is the efficacy data for retail, long-term care facilities, as you see yourself to that to date a little bit ahead. But if you look at the weekly scripts, we are coming down the peak we hear from and we said it was about walking real in some of them vaccination campaign ahead of and giving. It gives us plan ahead of Christmas between Thanksgiving and Christmas. But that is to be seen what happens with the leadership of Pepco. And then there is the IDN networks. As I said in my remarks, we have been working really very deep networks to increase the Covington flu vaccination rate versus last year. We built up a lot of visibility because those campaign started later most of them early October. We assume the retailers starting in August, which saw them something for very strong in August and early September. And that the government data for which we have no visibility, we only get all those women are those coming. So it's still I mean, this season, the shape is clearly different from last year and we carry We are hoping that we will work over returnables and I'll walk you might pay it off with your friendship and last year and then IDNs and government. So we'll have to see and we believe cause you to know them, but this market, but we believe it still remains stable. And Kevin direct, what we see that in many millions of people who want to see a reduction action.

因此，如果你考慮美國市場，我認為對我們來說重要的是專注於不同的管道，因為我們的戰線很少。正如我們所分享的，我們所掌握的數據是零售、長期照護機構的功效數據，正如您所看到的那樣。但如果你看一下每週的腳本，我們正在走下我們聽到的高峰，我們說這是關於在其中一些疫苗接種活動之前和給予中實際行動。它為我們提供了感恩節和聖誕節之間聖誕節前的計劃。但這還有待觀察 Pepco 的領導會發生什麼事。然後是 IDN 網路。正如我在演講中所說，我們一直在非常深入地建立網絡，以提高卡溫頓流感疫苗接種率（與去年相比）。我們建立了許多知名度，因為這些活動開始較晚，其中大部分是十月初。我們假設零售商從八月開始，他們在八月和九月初的表現非常強勁。我們看不到政府數據，我們只能得到所有那些即將到來的女性。所以我的意思是，這個季節的形狀與去年明顯不同，我們希望我們能在可回收產品上進行工作，我會告訴你，你可能會用你的友誼和去年來償還，然後是 IDN 和政府。所以我們必須看看，我們相信會讓你了解他們，但這個市場，但我們相信它仍然保持穩定。凱文直接表示，我們在數百萬人中看到了希望看到減排行動的情況。

Yes. Maybe I'll just add that remember, when we sell product, that is that tied to vaccinations. So when you look at the decline from the third quarter to the fourth quarter, we were a we had an early approval, just a final point to, therefore, can we were better ready to ship more within the third quarter. So that what I think you see on a year-over-year basis, what's happening?

是的。也許我會補充一點，請記住，當我們銷售產品時，這與疫苗接種有關。因此，當你看到從第三季度到第四季度的下降時，我們就得到了早期批准，這只是最後一點，因此，我們是否可以更好地準備在第三季度內發貨更多。那麼我認為您逐年看到的情況是，發生了什麼事？

Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

謝謝。我們的下一個問題來自摩根士丹利的特倫斯·弗林。您的線路已開通。

Hi, thanks for taking the question. I was just wondering on the INT. program, obviously are continuing to accelerate the clinical program here with the new Phase three among. But can you just give us an update on the manufacturing facility in Massachusetts and if that's still on track for completion by year end? And then if there's going to be a bridging work required by law, FDA for approval or validation. Thank you.

您好，感謝您提出問題。我只是想知道 INT 的情況。計劃，顯然正在繼續加速這裡的臨床計劃與新的第三階段。但您能否向我們介紹馬薩諸塞州製造工廠的最新情況以及該工廠是否仍有望在年底前完工？然後，如果需要進行法律、FDA 批准或驗證的橋樑工作。謝謝。

Good morning, Clarence. Yes, over the Kimco diesel do a great job or in the plant revolver, progress up the value on schedule. And so given what we showed at our in India and some of your timing we have here, the plants are will no longer be critical path to approval. But we're keeping the team working really hard and they are making great progress, were very pleased with that. And on the question of bridging come, once the plant is operational, will transition our clinical work to that plant as well. And so effectively, all the programs will include some from many of the programs may include, I should say on that data to the bridging will be Tom will be done industry.

早上好，克拉倫斯。是的，Kimco 柴油機做得很好，或者在工廠左輪手槍中，按計劃提高了價值。因此，考慮到我們在印度的展示以及你們在這裡的一些時間安排，這些工廠將不再是獲得批准的關鍵途徑。但我們讓團隊非常努力地工作，他們取得了很大的進步，我們對此感到非常高興。關於橋接問題，一旦工廠投入運營，我們的臨床工作也將轉移到該工廠。因此，所有計劃都將有效地包括許多計劃中可能包括的一些內容，我應該說，湯姆將在該行業中完成資料橋接。

Thank you. Our next question comes from Evan Wang with Guggenheim Securities. Your line is open.

謝謝。我們的下一個問題來自古根漢證券公司的 Evan Wang。您的線路已開通。

Hey, guys, thanks. And two from me. First on the election results. Just wondering, given the pending change in administration, what Gary Burge in place from policy or legislative standpoint that would meaningfully women's rights to companies that in the US, what steps are you doing to reach and are confident try and protect against potential increase in legal liabilities? And one RSV. of some competitors are describing how data announced dividend for expansion in international revenues at you agree there and what gives you confidence in Fairness Act you have specifically? Thanks.

嘿，夥計們，謝謝。還有我的兩個。首先是選舉結果。只是想知道，考慮到政府即將發生的變化，加里·伯奇從政策或立法的角度來看，採取了哪些措施對美國公司的婦女權利有意義，您正在採取哪些步驟來實現並有信心嘗試並防止法律可能增加負債？還有一份 RSV。一些競爭對手正在描述如何在您同意的情況下公佈股息以擴大國際收入，是什麼讓您對公平法案充滿信心？謝謝。

Good morning. Your final question. As you know, our mission of the company is to bring innovative medicines into well people, our prevent disease, Alzheimer's disease since the Company funding with work very closely with governments, media and public, a few deals around the world, including, of course, the U.S. And as you know, we work very collaboratively. We've further for exerts drug-drug his first term of 10. So we're going to continue to do that. Our mission is to leisure. We have people or do we increase of 3%, which is to then you're like me what the administration is then work on on RSV outside the US, as you know, the markets have approved, the products are very different times outside the U.S. We are very similar process that you have in the U.S. once you get approval to get for fall recommendation with UCDACB. quality, which in some markets up and at different times, then you have pricing negotiation, which, as you know, are quite different outside the U.S. In the U.S. Some timing might be, if you will see that because the timing of those different elements, as you know, in the US is of no pricing negotiation where you can lose some time most of cross-sell. So I think the so our ramp outside the US, who is reflecting both the recommendations that sometimes tend to be fall for the population, about 70 of avoid some countries, 75 and the goal and just the timing of orders in the case of mechanics to come together and then you get your quick Mr. You've done by a few weeks and you're just me as the season. So those are the dynamics happening outside the U.S. would cause you to believe that by the causes of utilization and helps people will argue vaccines level, the meaningful steps to prevent people are difficult to utilize, especially if you think in some of a tailwind. But we have an aging population in Europe. We have an aging population in Asia. And so I continue to believe that the overtime BRIC markets outside the US would be an important market that has a lot of education to move up. The consumer level of consumer doesn't even know what our view was until recently. So I don't know as of today, seven some doctors. So this is a lot of work to do. But the devices, nothing before surveys a need there. And we collectively need to work with probably country bills to prevent hospitalization. Everybody knows, especially in government that Siegel payoffs that vaccines are most probably the best all I got that you get it done, what has kept all and the best way to know hospitals with too many products to get production.

早安.你的最後一個問題。如您所知，我們公司的使命是將創新藥物帶給健康的人，我們預防疾病，阿茲海默症，因為公司與政府、媒體和公眾密切合作提供資金，當然包括世界各地的一些交易，美國，如您所知，我們的工作非常協作。我們也為他的第 10 個任期進一步發揮了作用。我們的使命是休閒。我們有人員，還是增加 3%，然後你就像我一樣，政府正在美國以外的 RSV 方面開展工作，如你所知，市場已經批准，產品在美國以外的時間有很大不同。與您在美國獲得UCDACB 秋季推薦批准後的流程非常相似。質量，在某些市場上，在不同的時間，然後你就需要進行定價談判，正如你所知，這在美國以外的地方是非常不同的。一些時機，因為這些不同元素的時機如您所知，在美國沒有定價談判，您可能會損失一些交叉銷售的時間。因此，我認為我們在美國以外的坡道反映了有時傾向於人口的建議，大約 70 種避免某些國家的建議，75 以及目標以及機械師下訂單的時間安排走到一起，然後你就得到了你的快速先生。因此，這些在美國以外發生的動態會讓你相信，由於使用的原因，人們會爭論疫苗的水平，預防人們採取有意義的措施是很難利用的，特別是如果你認為有一些順風的話。但歐洲人口老化。亞洲人口老化。因此，我仍然相信美國以外的金磚四國市場將是一個重要的市場，需要大量的教育才能提升。消費者的消費水準直到最近才知道我們的觀點是什麼。所以我不知道今天有七位醫生。所以這是很多工作要做。但在調查之前，這些設備是不需要的。我們需要共同配合可能的國家法案，以防止住院。每個人都知道，特別是在政府中，西格爾的回報是，疫苗很可能是我所擁有的最好的東西，也是讓所有醫院了解產品太多而無法生產的最佳方法。

Thank you. Our next question comes from Edward Tenthoff with Piper. Certainly your line is open.

謝謝。我們的下一個問題來自愛德華·滕托夫和派珀。當然你的線路是開放的。

Thank you very much. Appreciate all the time and all the detail. Since looking at the orphan disease pipeline on with respect to two of our pivotal trial starts for amendment in first half, and I think also maybe touch on generating some registrational of this year. What do you see is sort of the path forward here in terms of either the trial design, patient numbers follow up on? When do you think we could actually see on these two data that could lead to the home filing here? And thank you.

非常感謝。欣賞所有的時間和所有的細節。由於我們的兩項關鍵試驗的孤兒疾病管道在上半年開始進行修訂，我認為也可能涉及今年的一些註冊。您認為在試驗設計、病患數量跟進方面，前進的道路是什麼？您認為我們什麼時候可以真正看到這兩個數據，從而可以在這裡進行家庭歸檔？謝謝你。

Thanks, Ted. So that in both cases and be moving forward, as we said, either permanently or very quickly in 2025 in the case of M&A in a pivotal study designs. And the answer is a little bit different for both in the cases. And it may, as we've discussed previously. And we do believe there is a biomarker that can serve as the basis for approval. That's the subject of our discussions with the FDA that biomarker resolve that you can imagine can be achieved somewhat more quickly than in the case of PA. Will we be looking at? Because there's not as clear biomarker will be looking at event rates, which currently take some more time come in any event. And it will depend upon the rate of enrollment in those studies and then how quickly we can get to the deal. Ultimately, we hope is that a significant benefit of either with the biomarker or with the event rates compare as we've previously described at the R & D day. And we do expect that can happen within the next couple of years come. And our goal is to be launching that product in that sort of third window 2026 plus. But both of those cross, I should say, three to six plus time horizon. If we accrue patients more quickly into those studies, it could be sooner if it takes longer to be a little bit longer. And we'll obviously update as we go forward in how we're doing in enrollment in those studies.

謝謝，泰德。因此，正如我們所說，在這兩種情況下，在關鍵研究設計的併購案例中，要么永久地要么在 2025 年非常迅速地向前推進。這兩種情況的答案都有些不同。正如我們之前討論過的，它可能會發生。我們確實相信有一種生物標記可以作為批准的基礎。這是我們與 FDA 討論的主題，您可以想像生物標記解決方案可以比 PA 更快實現。我們會看嗎？因為沒有明確的生物標記來觀察事件發生率，無論如何，目前這需要更多的時間。這將取決於這些研究的入學率，以及我們能多快達成協議。最終，我們希望生物標記或事件發生率的顯著優勢與我們先前在研發日所描述的相比。我們確實預計這可能會在未來幾年內發生。我們的目標是在 2026 年以後的第三個窗口推出該產品。但我應該說，這兩者都跨越了三到六個時間跨度。如果我們更快地吸引患者參與這些研究，那麼如果需要更長的時間，研究可能會更快。隨著我們在這些研究的註冊方面的進展，我們顯然會更新。

Please conclude.

請得出結論。

Our next question comes from Luca Issi with RBC Capital. Your line is open.

我們的下一個問題來自 RBC Capital 的 Luca Issi。您的線路已開通。

oh, great. Thanks so much for taking my question. Maybe on our sees us with this year has been more challenging, has been in the late approval versus a time that it's contracting season. But how should we think about next year? Do you think it is fair for us to assume isn't yet a third of the market share given prefilled syringes and obviously no GBS? Or do you know there will be optimistic? And then maybe second on COVID in the US on how should we think about again, about market share here are listed in the law last year, you were gaining some share versus Pfizer versus this year. Looks like you're maybe are losing some shares versus them. So wondering if you can offer any additional color on that. Thanks so much.

哦，太好了。非常感謝您提出我的問題。也許在我們看來，今年我們更具挑戰性，與合約季節相比，我們已經處於較晚的批准階段。但我們該如何思考明年呢？您認為我們假設預充式註射器的市佔率不到三分之一且顯然沒有 GBS，這是否公平？或者你知道會有樂觀的嗎？然後也許是關於美國的新冠疫情，我們應該如何再次思考，關於去年法律中列出的市場份額，與今年的輝瑞相比，你獲得了一些份額。看起來你可能比他們失去了一些股份。所以想知道你是否可以提供任何額外的顏色。非常感謝。

Sure. So on that as we I mean, across products, we don't guide on shelf. So we're not going to stop guiding or share. As I said, we believe very much all that being able to contracting for Susan, I will be quite different from last year. So we've played itself in the 2025 season. In terms of COVID, you're correct in some of the return of market. We have lost some market share. As we've indicated earlier in the year. This has been quite an intense competitive environment in the US. What we don't know yet is the share in repair facility in the IDN and go unless we get a sense of both the share holistically at the end of this season. So that's a bit where we onstage.

當然。因此，正如我們所說，對於所有產品，我們不會在貨架上提供指導。因此，我們不會停止指導或分享。正如我所說，我們非常相信能夠為蘇珊簽約，我將與去年有很大不同。所以我們在 2025 年賽季已經發揮了自己的作用。就新冠疫情而言，你對市場回歸的一些看法是正確的。我們失去了一些市場份額。正如我們在今年早些時候指出的那樣。美國的競爭環境相當激烈。我們還不知道 IDN 和 go 中維修設施的份額，除非我們在本季結束時全面了解這兩個份額。這就是我們在舞台上的位置。

Thank you. Thanks so much.

謝謝。非常感謝。

Our next question comes from Courtney Bream with Bernstein. Your line is open.

我們的下一個問題來自伯恩斯坦的考特尼·布里姆。您的線路已開通。

Financing. Thanks for the time today and appreciate getting a question in a sense on that I was asked was around the I&C on. Obviously you have just initiated this new year and nine trial in non-small cell lung cancer, and that has the chemo combo are proceeding in the DINT. And does it change at reasons as to why you might be doing at running the trial that way could be that you're seeing tightness on the current paradigm is a falling in the direction of chemo combination has assigned to the belief that INT. was well in the post-chemo space, all kind of just about practical training trials in preparation. Can you give some context to that particular trial design? And then as we think about expansion of this program more broadly into other tumor area and kind of what's primarily gating now, is that the scientific signal there is that manufacturing capacity for the maintenance downtime?

融資。感謝您今天抽出寶貴的時間，並且很高興有人向我提出有關 I&C 的問題。顯然，你們剛在新的一年啟動了九項非小細胞肺癌試驗，而化療組合正在 DINT 中進行。它是否會改變你為什麼要以這種方式進行試驗的原因，可能是你看到當前範式的緊張性正在向化療組合的方向下降，這歸因於 INT 的信念。化療後的情況很好，所有的實際訓練試驗都在準備中。您能為該特定試驗設計提供一些背景資訊嗎？然後，當我們考慮將該計劃更廣泛地擴展到其他腫瘤領域以及現在主要的門控時，這是否是科學訊號，即維護停機時間的製造能力？

Great. Thank you for both questions. Some to first, in non-small cell lung cancer context, there has been a move is really evolving standard of care, just driven towards neoadjuvant use of Shire checkpoints and Keytruda specifically. And there are a number of patients is that have a pathologic complete response clearance of their tumor data elements of that. As a result of that, Neil Agilent chemo plus has gone Keytruda spam. And so recognizing that there's a move towards that standard of care, we also want to confirm the potential for IoT to benefit those patients. Obviously, you wouldn't be expecting a substantial benefit on those that have had a pathologic complete response because fortunately, they do have very good clearance or two tumor. And so the structure of the study is to oversee enroll patients, allow them to get that treatment. And approximately half, you can see that 680, we would expect to not have had that pathologic complete response, and that's the group. And then we then randomize and go see whether ion and he can add on top of Agilent at that point, Keith crude treatment with further Keytruda, some. And I really think the driver there is a view of where we see potential standard of care moving in the lung cancer space towards neoantigen and usage of Keytruda. And we there may be other applications. You're thinking more broadly where neoadjuvant treatment start to emerge and we choose to go study the benefit of INT. in the neoadjuvant setting, not just in the admin side. As far as other indications on the short version is that we continue with our partner, Merck to systematically look at all the places that we think that I actually can offer a benefit. We aren't done yet. There are more SaaS coming and we are pacing ourselves as we stand up those investments. But manufacturing capacity is only one of the considerations. Now it's not the primary consideration. To some extent. This is about also just pacing the start of the studies. As you can see, we're starting to build quite a large Phase two and Phase three program, and we just wanted to be disciplined about not having to meeting at the same time. So we will continue. We do continue to discuss with our partner, Merck, additional Phase three programs. We will start new ones in the coming year that we haven't yet announced. But and but we will see ourselves both for manufacturing and just simply the ability to execute in the overall scale of that of that program.

偉大的。謝謝你的兩個問題。首先，在非小細胞肺癌背景下，護理標準確實不斷發展，只是推動了 Shire 檢查點和 Keytruda 的新輔助使用。有許多患者的腫瘤數據元素具有病理學完全緩解。結果，Neil Agilent chemo plus 變成了 Keytruda 垃圾郵件。因此，認識到護理標準正在朝著這一方向發展，我們也想確認物聯網使這些患者受益的潛力。顯然，您不會期望那些已經獲得病理學完全緩解的患者能獲得實質益處，因為幸運的是，他們確實有很好的清除率或兩個腫瘤。因此，研究的結構是監督患者入組，讓他們接受治療。大約有一半，你可以看到，680，我們預計不會有病理性的完全反應，這就是這群人。然後我們隨機化，看看離子和他是否可以在安捷倫的基礎上添加基思進一步的Keytruda粗處理，一些。我真的認為驅動因素是我們看到肺癌領域潛在的護理標準朝著新抗原和 Keytruda 的使用方向發展。而且我們可能還有其他的應用。您更廣泛地思考新輔助治療從哪裡開始出現，我們選擇研究 INT 的益處。在新輔助治療中，而不僅僅是在管理方面。至於簡短版本的其他跡像是，我們將繼續與我們的合作夥伴默克公司一起系統地研究我們認為我實際上可以提供好處的所有地方。我們還沒完成。更多 SaaS 即將推出，我們正在調整自己的步伐，以支持這些投資。但製造能力只是考慮因素之一。現在已經不是首要考慮的了。在某種程度上。這也只是研究開始的節奏。正如您所看到的，我們正在開始建立相當大的第二階段和第三階段計劃，我們只是想遵守不必同時開會的紀律。所以我們會繼續。我們確實繼續與我們的合作夥伴默克討論其他第三階段計劃。我們將在來年啟動尚未宣布的新項目。但是，但是我們將看到自己的製造能力和執行該計劃總體規模的能力。

Thank you. Our last question comes from metals mysterious with Deutsche Bank. Your line is open. Please go ahead and roll out about. T

謝謝。我們的最後一個問題來自德意志銀行神秘的金屬。您的線路已開通。請繼續推出。時間

hank you for a quick question on the cycles from merchandise on behalf of the mine mill. So if approved, how quickly do you expect the new market transition to combination can call them, and we would expect to happen in 2025 already or more above our midterm a phone call? And secondly, what's the latest update it in perspective to have owned the COVID mitigation and such since the low 10s gains recent lawsuit on that? Thank you.

感謝您代表礦山工廠詢問有關商品週期的簡短問題。因此，如果獲得批准，您預計新的市場過渡到合併的速度會多快，我們預計會在 2025 年或早於我們的中期電話會議發生？其次，自 10 多歲的人最近對此提起訴訟以來，從擁有新冠疫情緩解措施等方面來看，最新的更新是什麼？謝謝。

Okay. Our positive outlook. I'll take the first question on timing and so on flu COVID, some obviously, it depends upon approval. And it's also dependent upon on public health through recommendation from a purely commercial launch timing perspective and contracting perspective. And we do not believe that 20 to 85 is the timing of that will happen this because a majority in the United States, the majority of the new contract wins happening really is currently in the year in the first quarter of the first half. And for that reason, given the timing of our current submission and approval, we wouldn't expect that to be essentially five that we would hope that it would happen in 2026. And ultimately, we are working towards that because we see a huge potential public health benefits. Tom, in terms of prevention of, yes, in other words, have hundreds of thousands of hospitalizations in the United States. If we can improve compliance with a COVID vaccine, things as well as deliver highly effective flu vaccine, um, but again, the timing of that will be contingent upon regulatory review process and then often that recommendation processes in different markets over the long term, we are believers that from a combination flu, COVID product in the right way for us to be protecting those at high risk of respiratory viruses seasonally in the markets in which we play. And so from a very long-term view, and we are quite bullish on the opportunity of the combo price.

好的。我們的積極前景。我將回答關於時間安排等有關流感新冠病毒的第一個問題，顯然，這取決於批准。而且它還依賴公眾健康，透過純粹商業發射時間角度和合約角度的建議。我們不認為 20 到 85 是發生這種情況的時間，因為在美國，大多數新合約的贏得實際上發生在今年上半年的第一季。出於這個原因，考慮到我們目前提交和批准的時間，我們預計這基本上不會是我們希望在 2026 年發生的五個。公共健康益處。湯姆，就預防而言，是的，換句話說，美國有數十萬人住院。如果我們能夠提高對新冠疫苗的依從性，並提供高效的流感疫苗，嗯，但同樣，其時機將取決於監管審查流程，然後往往是不同市場的長期建議流程，我們相信，針對混合型流感和新冠肺炎的產品，我們能夠以正確的方式保護我們所在市場中季節性呼吸道病毒高風險族群。因此，從長遠來看，我們非常看好組合價格的機會。

So we will not comment on the merits of GSK's case. We would note that such lawsuits are not uncommon during market formation of new technology, and we are prepared to defend also from these games. We look forward to presenting our case from one scheduled.

因此，我們不會評論葛蘭素史克案件的實質。我們注意到，在新技術的市場形成過程中，此類訴訟並不罕見，我們也準備好應對這些遊戲。我們期待按計劃展示我們的案例。

Thank you. Ladies and gentlemen, this does conclude the Q&A portion of today's conference. I would like to turn the call back over to Stephan 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。我想將電話轉回給史蒂芬，讓他發表結束語。

Thank you, everybody, for joining us today. We look forward to talking to many of you in the next days and weeks. Have a great day.

謝謝大家今天加入我們。我們期待在接下來的幾天和幾週內與你們中的許多人交談。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。您現在可以斷開連接並度過美好的一天。