莫德納 (MRNA) 2024 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to Moderna's First Quarter 2024 Conference Call. (Operator Instructions) Please be advised, this conference being recorded.

美好的一天，感謝您的支持。歡迎參加 Moderna 2024 年第一季電話會議。 （操作員說明）請注意，本次會議正在錄製中。

I would now like to hand the conference over to the speaker today, Lavina Talukdar. Please go ahead.

現在我想將會議交給今天的發言人拉維娜·塔魯克達爾 (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 2024 financial results and business updates. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website.

謝謝你，凱文。大家早安，感謝您參加今天的電話會議，討論 Moderna 2024 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審查的幻燈片。

On today's call are Stéphane Bancel, our Chief Executive Officer; Stephen Hoge, our President; and Jamey Mock, our Chief Financial Officer.

我們的執行長 Stéphane Bancel 出席了今天的電話會議；史蒂芬‧霍格，我們的總裁；以及我們的財務長 Jamey Mock。

Before we begin, please note, 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案》的安全港條款做出的前瞻性陳述。的文件，了解以下重要風險因素：可能導致我們的實際表現和結果與這些前瞻性陳述中明示或暗示的表現和結果有重大差異。

I will now turn the call over to Stéphane.

我現在將把電話轉給 Stéphane。

Thanks, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of our business. Jayme ill then present our financial results. Stephen will review our late-stage clinical programs, and I will close by sharing our 2024 commercial priorities and major upcoming milestones.

謝謝，拉維娜。大家早安或下午好。感謝您今天加入我們。我將從回顧我們的業務開始。 Jayme 接下來將介紹我們的財務表現。史蒂芬將回顧我們的後期臨床項目，最後我將分享我們的 2024 年商業優先事項和即將到來的主要里程碑。

Our COVID vaccine has already impacted hundreds of millions of people. I'm excited by the progress we've made with our pipeline that has the potential to impact many more people.

我們的新冠疫苗已經影響了數億人。我對我們在管道方面取得的進展感到興奮，這些進展有可能影響更多的人。

During the first quarter, we presented substantial clinical progress during our Vaccine Day, with exciting data on EBV, VZV and Norovirus. In addition, along with our partner, Merck, we expanded studies for Individualized Neoantigen Therapy, INT into 3 new indications.

第一季度，我們在疫苗日期間展示了實質的臨床進展，其中包括有關 EBV、VZV 和諾羅病毒的令人興奮的數據。此外，我們與我們的合作夥伴默克公司一起，將個體化新抗原治療 (INT) 的研究擴展到 3 個新適應症。

In addition, through ongoing Phase III studies in adjuvant melanoma and adjuvant non-small cell lung cancer, a Phase II/III study has started in neoadjuvant, adjuvant, cutaneous squamous cell carcinoma, another form of skin cancer.

此外，透過正在進行的輔助黑色素瘤和輔助非小細胞肺癌的 III 期研究，針對新輔助、輔助、皮膚鱗狀細胞癌（另一種形式的皮膚癌）的 II/III 期研究已經開始。

Phase II clinical trials have started in adjuvant bladder and adjuvant kidney cancer. Together, our vaccines and therapeutic portfolio have a potential to impact hundreds of millions of people each year.

輔助膀胱癌和輔助腎癌的 II 期臨床試驗已經開始。我們的疫苗和治療組合每年有可能影響數億人。

I am pleased with our Q1 performance. Since the beginning of the year, we announced 4 important business agreements and collaboration. We entered into a nonexclusive IP out licensing agreement with a leading pharmaceutical company in Japan. The agreement includes an upfront payment and low double-digit royalty to Moderna on net sales of our COVID key products marketed in Japan by this company. It is nice to see a company recognizing our IP and our figures for our license.

我對我們第一季的表現感到滿意。自年初以來，我們宣布了 4 項重要的業務協議和合作。我們與日本一家領先的製藥公司簽訂了非排他性智慧財產權授權協議。該協議包括根據 Moderna 在日本銷售的新冠關鍵產品的淨銷售額向 Moderna 支付預付款和兩位數的低特許權使用費。很高興看到一家公司認可我們的智慧財產權和我們的授權資料。

Second, we recently announced a contract to provide 4.5 million royalty of COVID-19 vaccine to the Ministry of Health in Brazil. I am very pleased with this partnership as it is the very first time that Moderna works with a broad environment, and we look forward to providing these doses to protect people in Brazil as they go into their winter season.

其次，我們最近宣布了一項向巴西衛生部提供 450 萬美元的 COVID-19 疫苗特許權使用費的合約。我對這次合作感到非常高興，因為這是 Moderna 第一次在廣泛的環境中合作，我們期待提供這些劑量來保護即將進入冬季的巴西人民。

We announced the project financing program for up to $750 million in funding to Blackstone to further develop our flu program. We also made public our collaboration with OpenAI to use AI as a transformative tool to increase speed and efficiency and ultimately to improve patient outcomes across our business.

我們宣布了向 Blackstone 提供高達 7.5 億美元資金的專案融資計劃，以進一步開發我們的流感專案。我們也公開了與 OpenAI 的合作，利用人工智慧作為變革性工具來提高速度和效率，並最終改善整個業務的病患治療效果。

Finally, we agreed with Metagenomi to terminate our gene editing collaboration. All rights granted under the collaboration will be returned to Metagenomi. This is a good proof point of Moderna's continually aim to prioritize our investment for our best opportunities to drive returns.

最後，我們同意 Metagenomi 終止我們的基因編輯合作。合作授予的所有權利將歸還給 Metagenomi。這很好地證明了 Moderna 始終致力於優先考慮我們的投資，以獲得推動回報的最佳機會。

Turning to Q1 financial results. In revenues, we were ahead of our plans at $167 million, reflecting a highly seasonal nature of our respiratory vaccine business. The net growth was $1.2 billion. We ended the quarter with $12.2 billion of cash and investments.

轉向第一季的財務表現。在收入方面，我們超出了計劃，達到 1.67 億美元，反映出我們呼吸道疫苗業務的高度季節性。淨成長為 12 億美元。本季結束時，我們擁有 122 億美元的現金和投資。

We communicated during our November call, our focus on financial discipline. I am pleased with what the team has achieved with our operating expenses, cost of manufacturing expenses plus cost of R&D expenses plus cost of SG&A expenses were down almost $800 million in Q1 2024 versus Q1 2023. Jamey will elaborate on this in his section.

我們在 11 月的電話會議中傳達了我們對財務紀律的關注。我對團隊所取得的成績感到滿意，我們的營運費用、製造費用成本、研發費用成本以及SG&A 費用成本與2023 年第一季相比，2024 年第一季減少了近8 億美元。他的部分中詳細闡述這一點。

With that, I will now hand over to Jamey.

現在，我將把工作交給傑米。

Thanks, Stéphane, and hello, everyone. Today, I will walk you through our financial performance for the first quarter and provide commentary on our 2024 financial framework.

謝謝，Stéphane，大家好。今天，我將向您介紹我們第一季的財務業績，並對我們 2024 年的財務框架進行評論。

Let me start with our commercial performance on Slide 8. Net product sales for Q1 were $167 million, down 91% year-over-year, mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside the United States. This decline aligns with the anticipated transition of the COVID-19 vaccine market or it's a seasonal pattern, whereas in the first quarter of 2023, we primarily delivered doses that were deferred from 2022.

讓我從幻燈片 8 上我們的商業表現開始。這種下降與 COVID-19 疫苗市場的預期轉變一致，或者說這是一種季節性模式，而在 2023 年第一季度，我們主要交付了從 2022 年推遲的劑量。

Q1 was driven by sales in the U.S. and the Rest of the World, largely Latin America markets. For Q2, we expect about $100 million in sales for a total of approximately $300 million in the first half of 2024. Q2 will include a portion of our recently announced contract with Brazil.

第一季是由美國和世界其他地區（主要是拉丁美洲市場）的銷售所推動的。對於第二季度，我們預計 2024 年上半年的銷售額約為 1 億美元，總銷售額約為 3 億美元。

Moving to Slide 9. Net product sales were $167 million, as I just explained. For the first quarter of 2024, our cost of sales was $96 million, which included third-party royalties of $8 million, inventory write-downs of $30 million and $27 million related to unutilized manufacturing capacity and wind out costs.

前往投影片 9。 正如我剛才所解釋的，淨產品銷售額為 1.67 億美元。 2024 年第一季度，我們的銷售成本為9,600 萬美元，其中包括800 萬美元的第三方特許權使用費、3,000 萬美元的庫存減記以及與未利用的製造產能和停產成本相關的2,700 萬美元。

This resulted in our cost of sales representing 58% of net product sales, up from 43% in the same quarter last year. The increase in cost of sales percentage was primarily due to the lowest level of sales in the quarter. We continue to expect the full year cost of sales to be approximately 35% of product sales. However, due to the strong seasonality of our business, we expect a higher percentage in the first half.

這導致我們的銷售成本佔產品淨銷售額的 58%，高於去年同期的 43%。銷售成本百分比的增加主要是由於本季銷售水準最低。我們仍然預計全年銷售成本將佔產品銷售額的 35% 左右。然而，由於我們業務的季節性較強，我們預計上半年的百分比會更高。

Moving to our R&D efforts. Q1 R&D expenses were $1.1 billion, reflecting a decrease of 6% year-over-year. This reduction was primarily due to the absence of upfront collaboration payments being made this quarter. The upfront payments made in the first quarter of 2023 were related to our strategic collaborations with Generation Bio and Life Edit Therapeutics.

轉向我們的研發工作。第一季研發費用為 11 億美元，年減 6%。這一減少主要是由於本季度沒有支付預付款。 2023 年第一季支付的預付款與我們與 Generation Bio 和 Life Edit Therapeutics 的策略合作有關。

With the Q1 spend of $1.1 billion, we are tracking towards the full year expected spend of approximately $4.5 billion. Q1 SG&A expenses were $274 million, marking a 10% decrease year-over-year. Importantly, this decrease was driven by all functions in SG&A, and it is a result of our strong focus on cost discipline and strategic investments, driving productivity. I will provide additional color on the next page.

第一季支出為 11 億美元，我們預計全年支出約 45 億美元。第一季 SG&A 費用為 2.74 億美元，年減 10%。重要的是，這一下降是由 SG&A 的所有職能部門推動的，也是我們高度重視成本控制和策略投資以提高生產力的結果。我將在下一頁提供額外的顏色。

We reported an income tax expense of $10 million for the first quarter of 2024 compared to an income tax benefit of $384 million in the same period last year. The shift is primarily due to the continued application of valuation allowance on the majority of our deferred tax assets, which we first established in the third quarter of 2023.

我們報告 2024 年第一季的所得稅費用為 1000 萬美元，而去年同期的所得稅優惠為 3.84 億美元。這項轉變主要是由於我們在 2023 年第三季首次設立的大部分遞延所得稅資產繼續採用估價備抵。

Net loss for the period was $1.2 billion compared to net income of $79 million last year. Diluted loss per share was $3.07 compared to diluted earnings per share of $0.19 in 2023. We ended the first quarter with cash and investments totaling $12.2 billion, down from $13.3 billion at year-end 2023, largely attributable to research and development expenses and operating activities.

該期間的淨虧損為 12 億美元，而去年的淨收入為 7,900 萬美元。稀釋後每股虧損為3.07 美元，而2023 年稀釋後每股收益為0.19 美元。研發費用和營運活動。

Moving to Slide 10. I want to take a moment to elaborate on the efficiencies we are now seeing across the company. As a platform company, we have the opportunity to build 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.

轉到幻燈片 10。作為一家平台公司，我們有機會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。

First, we ended 2023 with nearly 6,000 employees, up from 1,300 at the end of 2020. Every function scaled capabilities to enable the increasing product launches we expect over the coming years. Additionally, as you know, Moderna has always led with a digital-first mindset. Over the past 3 years, we have nearly doubled our built-for-purpose software applications to digitally enable our teams.

首先，到 2023 年年底，我們的員工人數從 2020 年底的 1,300 人增加到近 6,000 人。此外，如您所知，Moderna 始終以數位優先的思維方式引領潮流。在過去 3 年裡，我們的專用軟體應用程式數量幾乎增加了一倍，為我們的團隊提供數位支援。

As an example, we recently went live with the newly implemented rebuilt ERP system. SAP S4/Hana is our new digital backbone for all our operational activities. We have used SAP in the past, however, it was built for a research and development-focused company. And now we have implemented an entirely revised version, supporting our end-to-end business processes more effectively and efficiently.

舉個例子，我們最近啟用了新實施的重建的 ERP 系統。 SAP S4/Hana 是我們所有營運活動的新數位骨幹。我們過去曾使用過 SAP，但它是為一家專注於研發的公司而建造的。現在我們已經實施了一個完全修訂的版本，更有效和有效率地支援我們的端到端業務流程。

Another example is our rapid adoption of artificial intelligence. Over the past year, we have built over 750 GPTs. One example in the legal space, our contract companion GPT streamlines the task of reviewing and summarizing contracts across the business. With the GPT providing step-by-step guidance to craft a tailored and insightful salary.

另一個例子是我們對人工智慧的快速採用。在過去的一年裡，我們已經建造了超過 750 個 GPT。法律領域的一個例子是，我們的合約夥伴 GPT 簡化了整個企業的合約審查和總結任務。 GPT 提供逐步指導，以製定量身定制且富有洞察力的薪資。

This enables any function to extract critical insights on contracts whenever needed, minimizing bottlenecks and freeing up Moderna's legal department to focus on work of higher strategic value, thus enhancing operational efficiency and decision making.

這使得任何職能部門都可以在需要時提取有關合約的關鍵見解，最大限度地減少瓶頸，並使 Moderna 的法律部門能夠專注於具有更高戰略價值的工作，從而提高營運效率和決策制定。

Another example in G&A is a big purchase of paid GPT for all questions around our procurement and payment processes. Instead of our employees having to find and read policies and procedures, they can easily query to GPT. It also saves time for our procurement and payables teams from answering numerous questions.

G&A 中的另一個例子是大量購買付費 GPT，以解決有關我們採購和付款流程的所有問題。我們的員工不必尋找和閱讀政策和程序，他們可以輕鬆查詢 GPT。它還為我們的採購和應付帳款團隊節省了回答眾多問題的時間。

AI has already been a good chance for win in short period of time. In general, we see the areas helping incredible speed that allows for an unprecedented impact on productivity and many more. We have rolled out a comprehensive training program and are committed to driving this technology breakthrough.

AI成為短時間內獲勝的好機會。總的來說，我們看到這些領域有助於實現令人難以置信的速度，從而對生產力等產生前所未有的影響。我們推出了全面的培訓計劃，並致力於推動這項技術突破。

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As a result of these strategic investments in the people, processes and technology, we were able to significantly reduce purchase services and our use of external consultants, which contributed heavily to the 10% year-over-year reduction in SG&A spend. We are also seeing similar benefits in R&D and manufacturing.

由於對人員、流程和技術進行這些策略性投資，我們能夠大幅減少採購服務和外部顧問的使用，這在很大程度上導致 SG&A 支出年減 10%。我們在研發和製造方面也看到了類似的好處。

In general, we now have a solid foundation with our operating model. As we continue to grow our commercial activities, we will need to further invest, however we will be able to do that more efficiently.

總的來說，我們現在的營運模式已經有了堅實的基礎。隨著我們繼續發展商業活動，我們將需要進一步投資，但我們將能夠更有效地做到這一點。

Now let's turn to the 2024 financial framework on Slide 11, which is in line with what I shared on our last earnings call in February. We continue to expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025.

現在讓我們轉向投影片 11 上的 2024 年財務框架，該框架與我在 2 月的上次財報電話會議上分享的內容一致。我們仍然預計 2024 年的淨銷售額約為 40 億美元，我們認為這將是一個低點，因為我們預計將在 2025 年恢復成長。

Sales in the first half of the year are now expected to be approximately $0.3 billion. We continue to expect cost of sales of approximately 35% of product sales for the full year. For R&D we continue to expect full year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023.

目前預計今年上半年的銷售額約為 3 億美元。我們仍預期全年銷售成本約佔產品銷售額的 35%。對於研發，我們繼續預計全年研發費用約為 45 億美元，低於 2023 年的 48 億美元。

For SG&A, we continue to expect full year expenses to be approximately $1.3 billion down from $1.5 billion in 2023, and we expect taxes to be negligible in 2024 and capital expenditures in 2024 to be approximately $0.9 billion.

對於SG&A，我們繼續預計全年支出將從 2023 年的 15 億美元下降到約 13 億美元，並且我們預計 2024 年的稅收可以忽略不計，2024 年的資本支出約為 9 億美元。

Finally, we expect to end 2024 with approximately $9 billion in cash after touching a low point of approximately $8 billion at the end of Q3, due to the seasonality of collections.

最後，由於收款的季節性，我們預計在第三季末觸及約 80 億美元的低點後，到 2024 年底現金將約為 90 億美元。

Finally, let me also touch on our recently announced project financing deal with Blackstone, which we are excited about. In March, we entered into a development and commercialization funding arrangement, which commits Blackstone to providing us with up to $750 million of funding for our flu program, so that we can strengthen the product label and fulfill our remaining regulatory applications.

最後，我還想談談我們最近宣布的與 Blackstone 的專案融資協議，我們對此感到非常興奮。 3 月份，我們達成了一項開發和商業化融資安排，黑石承諾為我們的流感項目提供高達 7.5 億美元的資金，以便我們能夠加強產品標籤並完成我們剩餘的監管申請。

Subject to the regulatory approval in the United States, which depends on data from the funded activities, Blackstone will be entitled to receive up to $750 million in sales milestone payments. These milestone payments are contingent upon achieving specified cumulative net sales targets for our future influenza and combination vaccines.

待美國監管機構批准後（取決於資助活動的數據），Blackstone 將有權獲得高達 7.5 億美元的銷售里程碑付款。這些里程碑式的付款取決於我們未來流感疫苗和聯合疫苗能否實現指定的累積淨銷售目標。

Additionally, Blackstone will earn royalties on applicable net sales at a low single-digit percentage rate. This funding will offset our R&D expenses and is factored into our R&D framework for the year of approximately $4.5 billion. Overall, we are excited that this deal enables us to accelerate the advancement of our pipeline.

此外，黑石將以較低的個位數百分比從適用的淨銷售額中賺取特許權使用費。這筆資金將抵銷我們的研發費用，並計入我們今年約 45 億美元的研發框架中。總的來說，我們很高興這筆交易使我們能夠加快管道的進展。

And with that, I will now hand the call over to Stephen.

現在，我將把電話交給史蒂芬。

Thank you, Jamey. Today, I'll review updates from our clinical programs that were shared during our recent Vaccines Day, as well as new developments in our therapeutics portfolio.

謝謝你，傑米。今天，我將回顧我們在最近的疫苗日期間分享的臨床計劃的最新情況，以及我們的治療組合的新進展。

Starting with respiratory vaccines. We shared updates to many of our respiratory programs at Vaccines Day in March. Our RSV vaccine in Canada is undergoing regulatory review in multiple countries. And pending approval, we expect to launch the product in the United States following the June ACIP meeting and recommendations this year.

從呼吸道疫苗開始。我們在三月的疫苗日分享了許多呼吸系統計畫的最新資訊。我們在加拿大生產的 RSV 疫苗正在多個國家接受監管審查。在等待批准之前，我們預計將在今年 6 月的 ACIP 會議和建議之後在美國推出該產品。

At Vaccines Day, we shared updates from co-administration studies of RSV, confirming the ability to administer our vaccine and other vaccines given during the respiratory season.

在疫苗日，我們分享了 RSV 聯合給藥研究的最新進展，確認了我們的疫苗和呼吸道季節期間接種的其他疫苗的接種能力。

With our flu program, we recently presented data from our Phase III P303 study at ECCMID and continued discussions with regulators globally towards the goal of filing this year. For our next-generation COVID vaccine, mRNA-1283, we have presented positive Phase III safety and immunogenicity data and are engaging with regulators on the path to approval for that product. Our combination flu and COVID vaccine, mRNA-1083 is in Phase III, and we look forward to sharing those clinical data in the current quarter.

透過我們的流感項目，我們最近在 ECCMID 提交了 III 期 P303 研究的數據，並繼續與全球監管機構進行討論，以實現今年提交申請的目標。對於我們的下一代新冠疫苗 mRNA-1283，我們已經提供了積極的 III 期安全性和免疫原性數據，並正在與監管機構合作，以爭取該產品的批准。我們的流感和新冠肺炎合併疫苗 mRNA-1083 正處於 III 期階段，我們期待在本季度分享這些臨床數據。

Turning now to our leading and other vaccines. As shared at Vaccines Day, we've had -- we've made significant progress in this portfolio. Our CMV vaccine, mRNA-1647, has fully enrolled its Phase III trial, and we have the potential for an interim analysis of efficacy this year. We announced positive Phase I immunogenicity and safety data from our EBV vaccine candidate, mRNA-1189, and we are now advancing towards pivotal trials with that program.

現在轉向我們的主要疫苗和其他疫苗。正如在疫苗日上分享的那樣，我們在這項投資組合方面取得了重大進展。我們的 CMV 疫苗 mRNA-1647 已全面進入 III 期試驗，我們有可能在今年進行中期療效分析。我們宣布了我們的 EBV 候選疫苗 mRNA-1189 的 I 期免疫原性和安全性積極數據，我們現在正在推進該計劃的關鍵試驗。

A second therapeutic EBV candidate, mRNA-1195 is in a separate ongoing Phase I study. mRNA-1468, our vaccine against varicella-zoster virus showed strong immunogenicity, including strong T cell responses, and we are preparing to move that program forward towards a pivotal Phase III study as well.

另一種治療 EBV 候選藥物 mRNA-1195 正在進行一項單獨的 I 期研究。我們針對水痘帶狀皰疹病毒的疫苗 mRNA-1468 顯示出強烈的免疫原性，包括強烈的 T 細胞反應，我們也準備好將該計劃推進到關鍵的 III 期研究。

And our HSV vaccine against Herpes simplex mRNA-1608, is now fully enrolled in its Phase I/II study, and we look forward to sharing clinical data updates when that's available. Now rounding out this portfolio, we presented the positive clinical data from our norovirus vaccine candidate, mRNA-1403 and shared that we are advancing that program towards its pivotal Phase III trial.

我們針對單純皰疹 mRNA-1608 的 HSV 疫苗現已全面進入 I/II 期研究，我們期待在可用時分享臨床數據更新。現在，我們展示了我們的諾羅病毒候選疫苗 mRNA-1403 的積極臨床數據，並表示我們正在將該計劃推進到關鍵的 III 期試驗，從而完善了該產品組合。

Turning now to Oncology Therapeutics. We are happy to report our ongoing Phase III studies are enrolling well. We were excited to announce 3 new INT trials, including a randomized Phase II/III study in neoadjuvant, adjuvant cutaneous squamous cell carcinoma; a randomized Phase II trial in adjuvant high-risk muscle invasive bladder cancer; and lastly, a randomized Phase II trial in an adjuvant renal cell carcinoma.

現在轉向腫瘤治療。我們很高興地報告我們正在進行的第三階段研究進展順利。我們很高興地宣布 3 項新的 INT 試驗，包括一項針對新輔助、輔助皮膚鱗狀細胞癌的隨機 II/III 期研究；一項針對輔助高風險肌肉浸潤性膀胱癌的隨機 II 期試驗；最後是一項針對輔助性腎細胞癌的隨機 II 期試驗。

Now recently at AACR, we presented Phase I data from our INT program in advanced unresectable HPV-negative head and neck cancer in the metastatic setting. At AACR, we also presented Phase I translational data from another oncology therapeutic program, mRNA-2752 in various tumor types. Links to both of these presentations are provided on the slide.

最近，我們在 AACR 上展示了 INT 計畫在轉移性晚期不可切除 HPV 陰性頭頸癌中的 I 期數據。在 AACR 上，我們也展示了另一個腫瘤治療項目 mRNA-2752 在各種腫瘤類型中的 I 期翻譯數據。幻燈片上提供了這兩個簡報的連結。

Now as a final note, at ASCO, we'll be hosting another Moderna oncology event on the evening of June 3, and we look forward to seeing you there or having you join us virtually.

最後，我們將於 6 月 3 日晚間在 ASCO 舉辦另一場 Moderna 腫瘤學活動，我們期待在那裡見到您或透過虛擬方式加入我們。

With that, I'll turn it back over to Stéphane.

這樣，我會將其轉回給 Stéphane。

Thank you, Stephen and Jamey. Slide 18 is an overview of our COVID-19 strategy for 2024, which is focused on the need of each 2 region.

謝謝你們，史蒂芬和傑米。幻燈片 18 概述了我們 2024 年的 COVID-19 策略，該策略重點關注兩個地區的需求。

In the U.S., our focus is working with public health officials, health care providers and pharmacies to increase vaccination coverage rates. In Europe, we are actively participating in the 2024 tender process. The tender allows for up to 36 million doses per year for up to 4 years. And in the Rest of the World, we have reoriented our commercial teams to prioritize markets for greater commercial focus and impact.

在美國，我們的重點是與公共衛生官員、醫療保健提供者和藥房合作，以提高疫苗接種覆蓋率。在歐洲，我們正積極參與 2024 年招標過程。此招標允許在長達 4 年內每年最多提供 3,600 萬劑疫苗。在世界其他地區，我們重新調整了我們的商業團隊，優先考慮市場，以獲得更大的商業重點和影響力。

As mentioned earlier, the Brazil contract is an example of how this is working. In the fall of 2023, U.S. COVID vaccination rates lagged behind flu-vaccination rates. U.S. COVID vaccination rates were 11%, with flu vaccination rates at 4x that. And yes, COVID continues to show a higher (inaudible) dieses.

如前所述，巴西合約就是其運作方式的一個例子。 2023 年秋季，美國新冠疫苗接種率落後於流感疫苗接種率。美國新冠疫苗接種率為 11%，流感疫苗接種率為 4 倍。是的，新冠肺炎的死亡率持續上升（聽不清楚）。

U.S. operation for COVID began October 2023. And last week, we have 424,000 people, which is markedly higher demonstration from either flu or RSV infection. Actually, COVID operations were around the same level as (inaudible) of flu plus RSV combined.

美國針對新冠肺炎的行動於 2023 年 10 月開始。事實上，新冠肺炎疫情的運作水準與（聽不清楚）流感加呼吸道合胞病毒的總和大致相同。

In addition, long COVID continues to be a serious risk to many healthy young adults in their 20s, their 30s, their 40s are losing lung capacity and the mental capacity due to long COVID. The data shows that COVID-19 vaccine reduced the risk of long COVID by 70%.

此外，長期感染新冠病毒仍對許多20多歲、30多歲、40多歲的健康年輕人構成嚴重風險，他們因長期感染新冠病毒而喪失肺活量和心智能力。數據顯示，COVID-19疫苗可將長期感染新冠病毒的風險降低70%。

We believe education and awareness will be very important. We are working on educating consumers about the need for an annual COVID vaccine, just like flu. Too many people are getting hurt when we have safe and effective vaccines available. Our job will not stop until these vaccination numbers come down significantly.

我們相信教育和意識將非常重要。我們正在努力教育消費者了解每年接種新冠疫苗的必要性，就像流感疫苗一樣。當我們擁有安全有效的疫苗時，太多人受到傷害。在疫苗接種數量大幅下降之前，我們的工作不會停止。

As you know, strength selection by health authorities received approval and launch of COVID vaccine. Health authorities including the WHO and EMA in Europe, have recently selected the JN.1 strain for the 2024-25 formula. The FDA will launch the [real fast] meeting on May 16 to select the strength for the U.S. market.

如您所知，衛生當局的實力選擇獲得了新冠疫苗的批准和推出。包括 WHO 和歐洲 EMA 在內的衛生當局最近為 2024-25 年配方奶粉選擇了 JN.1 菌株。 FDA 將於 5 月 16 日召開[真正快速]會議，為美國市場選擇強項。

Moderna has already manufactured JN.1 drug substance to support the potential August launch. We have also prepared for backups in case the FDA does not select JN.1. In 2023, COVID vaccines were available 5 weeks later after 2 vaccines. In the recent channel alone, more than 3 million flu vaccines were administered before the updated COVID vaccines were available.

Moderna 已經生產了 JN.1 原料藥，以支援可能在 8 月推出的產品。我們也準備了備份，以防 FDA 不選擇 JN.1。 2023 年，新冠疫苗在接種 2 種疫苗後 5 週後即可上市。僅在最近的頻道中，在更新的新冠疫苗上市之前就接種了超過 300 萬劑流感疫苗。

As we look into the fall 2024 season, we see the potential to align the timing of flu and COVID vaccine approvals. We are encouraged by the earlier (inaudible) meeting for this year's COVID trend selection versus last year. And we're working here and (inaudible) for timely COVID approval. We expect higher vaccination uptake if COVID vaccines are available sooner.

當我們展望 2024 年秋季季節時，我們看到了調整流感和新冠疫苗批准時間的潛力。我們對今年較早（聽不清楚）的新冠趨勢選擇會議（與去年相比）感到鼓舞。我們正在這裡工作（聽不清楚）以便及時獲得新冠肺炎批准。如果新冠疫苗盡早上市，我們預計疫苗接種率會更高。

Turning now to the anticipated launch of our second respiratory vaccine, or RSV vaccine, which is expected to launch into a large market. In its first year, the older adult RSV market was $2.5 billion in sales, and analysts expect the older adults' market to grow between $6 billion and $8 billion per year. With marketing application filed in markets globally, we are anticipating approval beginning in the first half of 2024. In the U.S., we're targeting a launch after the June ACIP meeting.

現在談談我們預計推出的第二種呼吸道疫苗，即 RSV 疫苗，預計將進入一個大市場。第一年，老年人 RSV 市場的銷售額為 25 億美元，分析師預計老年人市場每年將成長 60 億至 80 億美元。隨著在全球市場上提交行銷申請，我們預計將於 2024 年上半年開始獲得批准。

We are very excited to bring a product from a strong differentiated profile to market. Our vaccine has a strong efficacy and safety in clinical trials, and we'll be the only product available in the pre-lled syringe or PFS presentation.

我們非常高興能夠將具有強大差異化特徵的產品推向市場。我們的疫苗在臨床試驗中具有很強的功效和安全性，我們將成為唯一可提供預填充注射器或 PFS 演示的產品。

Let me now double-click on what we believe are the benefit of PFS. We recently published a time and motion study that shows faster preparation time for PFS relative to vaccines that require constitution. We call that both RSV combination vaccines on the market require multiple steps to prepare their vaccines for administration.

現在讓我雙擊我們認為 PFS 的好處。我們最近發表了一項時間和運動研究，顯示與需要配製的疫苗相比，PFS 的準備時間更快。我們認為市面上的兩種 RSV 組合疫苗都需要多個步驟來準備其疫苗以供給藥。

One vaccine requires process and the overall next steps to prepare. Our PFS presentation is ready to use vaccine straight out of the box. The study from the PFS presentation to be 3x to 4x more efficient as measured by preparation time. Details from the study can be found through the link on the slide.

一種疫苗需要流程和整體的後續步驟來準備。我們的 PFS 簡報已準備好直接使用開箱即用的疫苗。根據準備時間衡量，PFS 演示的研究效率提高了 3 到 4 倍。該研究的詳細資訊可以透過幻燈片上的連結找到。

We believe our PFS presentation for RSV vaccine has the potential to ease the personal burden on pharmacies during the fall respiratory season. The pharmacy chains (inaudible) independent pharmacies and we're looking forward to the launch.

我們相信，我們針對 RSV 疫苗的 PFS 演示有可能減輕秋季呼吸季節期間藥房的個人負擔。藥房連鎖（聽不清楚）獨立藥房，我們期待它的推出。

Let me close with major upcoming pipeline milestones. While we're excited about the commercial prospects for the year, we're even more excited about the upcoming pipeline milestone and the effect they will have on our commercial outlook for the next several years serving patients.

讓我以即將到來的主要管道里程碑作為結束語。雖然我們對今年的商業前景感到興奮，但我們對即將到來的管道里程碑以及它們將對我們未來幾年為患者服務的商業前景產生的影響感到更加興奮。

In respiratory vaccines, we are eagerly awaiting the approval of RSV and the (inaudible). We are also waiting for data for RSV in the age group 18 and above. We are in discussion with regulators on our flu program and intend to file in 2024. We won next-gen COVID vaccine and on (inaudible), we are pleased with a positive Phase III immunogenicity data and are engaging with regulators. Our flu plus COVID vaccine combo should get this Phase III data soon.

在呼吸道疫苗方面，我們熱切等待 RSV 和（聽不清楚）的批准。我們還在等待 18 歲及以上年齡組的 RSV 數據。我們正在與監管機構討論我們的流感計劃，並打算在2024 年提交申請。合作。我們的流感加新冠疫苗組合應該很快就會得到第三階段的數據。

In latent with CMV fully enrolled and at current cases, we look forward to potential for Phase III data efficacy data in 2024. In our INT program, we're looking forward to completion of enrollment for Phase III adjuvant melanoma study. In addition, we are keen to discuss the possibility of accelerated approval with regulators based on Phase II study data.

在 CMV 完全入組和目前病例的情況下，我們期待 2024 年可能獲得 III 期數據療效數據。此外，我們熱衷於根據二期研究數據與監管機構討論加速批准的可能性。

As we shared before, there are 3 things we view as necessary before we could consider pursuing fed approval for INT. First, durability data from our Phase II study, which we announced in December last year; second, a substantially enrolled Phase III adjuvant melanoma study; and third, manufacturing readiness at the Marlborough site. And last but not the least, our revenue portfolio, we look forward to initiating pivotal study for PMMA.

正如我們之前分享的，在我們考慮尋求聯準會批准 INT 之前，我們認為有 3 件事情是必要的。首先是我們去年 12 月宣布的第二階段研究的耐久性數據；其次，一項大量入組的 III 期輔助黑色素瘤研究；第三，馬爾堡工廠的生產準備。最後但並非最不重要的一點是，我們的收入組合，我們期待啟動 PMMA 的關鍵研究。

This milestone will represent continued progress towards our mission to deliver the greatest possible impact to people for mRNA medicines. And asModerna, we are dedicated to achieving them all. Every data continues to confirm the power of our platform and its breadth in the service of patients. Two important save a date for your calendars. We will discuss our COVID program in Chicago on June 1, and our annual R&D Day will be held in New York the morning of September 1.

這一里程碑將代表我們在實現 mRNA 藥物為人們帶來最大可能影響的使命方面不斷取得進展。作為 Moderna，我們致力於實現這一切。每項數據都不斷證實我們平台的力量及其為病人服務的廣度。為您的日曆儲存兩個重要的日期。我們將於 6 月 1 日在芝加哥討論我們的新冠病毒計劃，我們的年度研發日將於 9 月 1 日上午在紐約舉行。

Thank you for listening, and we look forward to taking your questions. Operator?

感謝您的聆聽，我們期待回答您的問題。操作員？

(Operator Instructions) Our first question comes from Salveen Richter with Goldman Sachs.

（操作員說明）我們的第一個問題來自高盛的 Salveen Richter。

Firstly, could you discuss your strategy for pursuing contracts for the RSV vaccine given 2 approved vaccine sort of have a head start, timing-wise? And help us understand, as you've communicated with large retail pharmacy, how significant the PFS formulation is to them?

首先，您能否討論一下您尋求 RSV 疫苗合約的策略，因為兩種已獲批准的疫苗在時間上處於領先地位？並幫助我們了解，正如您與大型零售藥局溝通的那樣，PFS 配方對他們來說有多重要？

And then secondly, with regard to moving into the 3 new indications for the INT program. Maybe help us understand signals or specific data points that support that?

其次，關於 INT 計劃的 3 個新適應症。也許可以幫助我們理解支持這一點的訊號或特定數據點？

On the RSV contract. So as you know, we are not allowed to contract until the product is approved by the regulators. But what we are doing, because we can do that, is our medical teams are actively engaged with retail pharmacies, but also IV and hospital networks in terms of making sure the data on the efficacy profile of the product, on safety, and of course, in the PFS and the benefit of PFS in terms of productivity. Those discussions are ongoing literally on a daily basis, including with leadership of those pharmacies. And the next step, of course, is to wait for the FDA approval. Stephen?

關於 RSV 合約。如您所知，在產品獲得監管機構批准之前，我們不得簽訂合約。但我們正在做的是，因為我們可以做到這一點，我們的醫療團隊積極與零售藥店以及靜脈注射和醫院網絡合作，以確保產品功效、安全性以及當然的數據。生產力方面的好處。這些討論實際上每天都在進行，包括與這些藥房的領導層的討論。下一步當然是等待 FDA 的批准。史蒂芬？

Yes, sure. So thanks for the question. So on the 3 additional INT indications, I think the short version of it is they are all adjuvant settings. Similar to our melanoma Phase II results have been so encouraging, where KEYTRUDA has a known benefit and where we still believe that there's an opportunity to improve on that by driving a specific T cell response with INT.

是的，當然。謝謝你的提問。所以關於 3 個額外的 INT 指示，我認為簡單來說它們都是輔助設定。與我們的黑色素瘤 II 期結果類似，令人鼓舞，KEYTRUDA 具有已知的益處，我們仍然相信有機會透過 INT 驅動特定 T 細胞反應來改善這一點。

And so as you know, in Phase I, we looked across a range of different indications. That was more in the metastatic setting. But as we've announced since we first saw that positive Phase II results from melanoma, we have been aggressively pursuing adjuvant indications where IO is approved and where we see an opportunity. And all 3 of these fits squarely in that space.

如您所知，在第一階段，我們研究了一系列不同的適應症。這更多是在轉移性環境。但正如我們所宣布的，自從我們第一次看到黑色素瘤的第二階段積極結果以來，我們一直在積極尋求 IO 獲得批准和我們看到機會的輔助適應症。所有這三個都完全適合這個空間。

Our next question comes from Michael Yee with Jefferies.

我們的下一個問題來自 Jefferies 的 Michael Yee。

Two questions as well. On RSV, I guess, the competitor GSK as well this week was commenting about how they're expecting you to be in the mix and contracting is ongoing. I know you have some RSV in your guidance. I think the math implies maybe hundreds of millions of dollars. Can you just perhaps comment on how you adjusted, or probability adjusted or thought about how much is there in your guidance and your confidence on that for this year?

還有兩個問題。我想，在 RSV 上，競爭對手葛蘭素史克 (GSK) 本周也發表了評論，表示他們希望您加入其中，並且合約正在進行中。我知道您的指導中有一些 RSV。我認為數學可能意味著數億美元。您能否評論一下您如何調整，或機率調整或思考您今年的指導和信心有多少？

And then secondly, on INT as well. I know you had some data at ASCO. I know you have breakthrough therapy and prime designation. How important is the Phase III enrollment progress, the confirmatory study? I feel like that's always an important discussion with FDA. So how important is that progress before you can really engage with FDA?

其次，還有 INT。我知道你在 ASCO 有一些數據。我知道您擁有突破性療法和主要資格。 III 期入組進展（驗證​​性研究）有多重要？我覺得這始終是與 FDA 的重要討論。那麼，在您真正與 FDA 合作之前，這項進展有多重要呢？

Yes. Maybe I'll take the first one. Thanks, Mike, for the question.

是的。也許我會選擇第一個。謝謝邁克提出這個問題。

So as you may know, we haven't guided any specific guidance or number for RSV. In the past, we did break down the $4 billion into 3 different segments around the U.S. market, the APAs we walked into the year with and then another category of other COVID sales that didn't have any APAs across the rest of the world, a good example is Brazil that we just signed, as well as RSV. So no specific guidance for RSV from a financial perspective.

如您所知，我們尚未為 RSV 提供任何具體指導或數字。過去，我們確實將美國市場的 40 億美元分成了 3 個不同的部分，即我們進入當年的 APA，然後是世界其他地區沒有任何 APA 的其他新冠銷售類別，一個很好的例子是我們剛剛簽署的巴西以及RSV。因此，從財務角度來看，RSV 沒有具體的指導。

And your question on INT. I think you nailed it, it's a really important topic, and in particular right now, as we think about accelerated approval that we demonstrate the diligence and substantially enroll the confirmatory study. So really all you're waiting for is for that study to mature, it could be several years.

還有你關於 INT 的問題。我認為你說得對，這是一個非常重要的主題，特別是現在，當我們考慮加速批准我們表現出勤奮並大量招募驗證性研究時。所以實際上你所等待的就是這項研究成熟，這可能需要幾年的時間。

We think it's really important. To be fair, we have not consulted with the agency on that yet. As we've said, we're waiting until we crossed our own threshold. And also at this point, until we've established the manufacturing facility with that line of sight to that.

我們認為這非常重要。公平地說，我們還沒有就此與該機構進行協商。正如我們所說，我們正在等待，直到我們跨過自己的門檻。同樣在這一點上，直到我們建立了具有該視線的製造設施。

But we do feel that, as we've said, substantial enrollment demonstrating that essentially all you're waiting for is the readout on that confirmatory study is our obligation before we even want to go forward with that question.

但我們確實認為，正如我們所說，在我們想繼續討論這個問題之前，大量的註冊表明您所等待的只是驗證性研究的結果，這是我們的義務。

We are making great progress this year, and we're optimistic that both that and the facility will be available in short order. And then, of course, we'll want to start engaging with our data, including the FDA on the question of accelerated approval.

今年我們取得了巨大進展，我們樂觀地認為這兩個方面以及該設施將在短期內投入使用。然後，當然，我們會開始處理我們的數據，包括 FDA 關於加速批准問題的數據。

Our next question comes from Terence Flynn with Morgan Stanley.

我們的下一個問題來自摩根士丹利的特倫斯·弗林。

Great. Maybe two parts for me. Just on the RSV vaccine. Can you provide your latest perspective on what the most likely ACIP recommendation will be? Will you get a parity recommendation to the competitors? Or do you think there's a potential for a differential recommendation here?

偉大的。也許對我來說有兩個部分。就在 RSV 疫苗上。您能否提供您對最有可能的 ACIP 建議是什麼的最新看法？您會得到與競爭對手同等的推薦嗎？或者您認為這裡有可能提出差異化推薦嗎？

And then just wondering any update on your ongoing conversations regarding filing your seasonal flu vaccine? I know you mentioned in your prepared remarks, but just any more insight in terms of what the gating steps are here.

然後只是想知道您正在進行的關於提交季節性流感疫苗的對話有什麼更新嗎？我知道您在準備好的發言中提到過，但只是對這裡的門控步驟有更多的見解。

Thanks for both questions. So first on RSV, caveat by saying we have to complete the approval process with FDA. And then at the end of the day, the recommendation really falls to ACIP and the committee members, so I defer to them.

感謝您提出兩個問題。首先，關於 RSV，需要注意的是，我們必須完成 FDA 的核准程序。最終，建議確實落到了 ACIP 和委員會成員的手中，所以我聽從了他們的建議。

Our expectation, our hope is that when they review the data package that we already have as well as additional data that we expect to be able to share at the ACIP meeting on durability through a second season, on immunogenicity across other populations, we expect a parity recommendation. We certainly think the data supports that. But again, I'll defer to the committee members on the ultimate decision.

我們的期望，我們的希望是，當他們審查我們已經擁有的數據包以及我們希望能夠在 ACIP 會議上分享的關於第二季的持久性和其他人群的免疫原性的額外數據時，我們預計平價推薦。我們當然認為數據支持這一點。但同樣，我將聽從委員會成員的最終決定。

On the question of flu, we are actively engaged right now on the -- with regulators on the process for submission of the flu vaccine. As I mentioned a moment ago, we are also closing in on clinical data from our combination flu COVID vaccine, mRNA-1083. And that obviously has an important role in our engagement with regulators, generally on flu versus flu COVID combination.

關於流感問題，我們目前正積極與監管機構合作，討論流感疫苗的提交流程。正如我剛才提到的，我們也正在接近我們的流感新冠疫苗 mRNA-1083 的臨床數據。這顯然在我們與監管機構的接觸中發揮著重要作用，通常是在流感與流感新冠組合方面。

And so those discussions are ongoing. I won't provide any other update on it except to say, as we've said today, and we will continue to say we expect to file the flu product this year, but it will be dependent upon a number of considerations plus we also including the (inaudible) data that we expect to see soon.

因此，這些討論正在進行中。我不會提供任何其他更新，除了說，正如我們今天所說的，我們將繼續說我們預計今年提交流感產品，但這將取決於許多考慮因素，加上我們也包括我們預計很快就會看到的（聽不清楚）數據。

Our next question comes from Eli Merle with UBS.

我們的下一個問題來自瑞銀集團的 Eli Merle。

On CMV, how are you thinking about the need or benefits of potentially boosting both from a clinical as well as a commercial perspective? And if you would study those? And then second, just on CMV, if you don't meet the interim, the analysis there, would you disclose that?

關於 CMV，您如何從臨床和商業角度考慮潛在增強 CMV 的必要性或益處？如果你願意研究這些？其次，就 CMV 而言，如果您不符合臨時分析要求，您會透露這一點嗎？

So first, on the question of boosting. So far, what we have -- we obviously don't have the efficacy readout. That's the Phase III study is ongoing. But we do expect to have quite substantial durability data on immunogenicity. And it's quite possible that the efficacy data will give us a signal what the core of production could be.

首先，關於提升的問題。到目前為止，我們所擁有的——顯然我們還沒有功效讀數。第三階段研究正在進行中。但我們確實期望獲得相當多的關於免疫原性的耐久性數據。功效數據很可能會給我們一個訊號，告訴我們生產的核心是什麼。

And so we don't, right now, have any evidence they're not good, durable, multiyear, possibly as long as 5 years, we continue to track the immunogenicity protection. It's possible that will extend out to 10 years and then some boosting is necessary. It's also possible that we decide that a booster might be necessary shorter term in that, let's say, 5 years or 10 years.

因此，我們現在沒有任何證據表明它們的效果不好、持久、多年，可能長達 5 年，我們將繼續追蹤免疫原性保護。有可能會延長至 10 年，然後需要進行一些提升。我們也有可能決定在短期內需要加強助推器，比如說 5 年或 10 年。

We just don't know at this time. And so at present, the data we do have on the durability of the immunogenicity, it looks quite strong. And so we do think our 3-dose series will likely be protective for a very long period of time, all subject to the efficacy data that you just referenced.

我們現在還不知道。因此，目前我們掌握的關於免疫原性持久性的數據看起來相當強大。因此，我們確實認為我們的 3 劑系列可能會在很長一段時間內發揮保護作用，所有這些都取決於您剛才引用的功效數據。

So on the interim analysis for efficacy, as we've said before, we're making great progress in that study in accruing cases, and we do expect to be able to provide an update on -- or conduct at least an initial interim efficacy analysis this year.

因此，在療效的中期分析方面，正如我們之前所說，我們在累積病例的研究中取得了巨大進展，並且我們確實希望能夠提供更新，或至少進行初步的中期療效今年分析。

Because of the rate of case accrual and also because the protocol calls for us to cross a median of 1-year follow-up, the timing may be sets -- by the time we get to that first interim analysis, we are also have enough cases for a final analysis or that a final analysis is imminent. Let's say, it's a very short period of time away.

由於病例應計率，也因為協議要求我們跨越一年追蹤的中位數，時間可能已經確定——當我們進行第一個中期分析時，我們也有足夠的時間需要進行最終分析或即將進行最終分析的情況。比方說，距離很短。

And so because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don't think we can commit, one way or the other, whether we're going to be updating, it will really depend upon the data we see and then how quickly we expect to get that final analysis.

因此，由於這種不確定性，在我們看到這些數據並了解我們距離最終分析有多接近之前，我認為我們無法承諾，無論我們是否要更新，它真的會取決於我們看到的數據以及我們期望多快獲得最終分析。

At the end of the day, if we have news to share both on interim and the final, we, of course, will, but I don't think we can commit at this stage because we haven't seen the data yet.

歸根結底，如果我們有關於中期和決賽的消息要分享，我們當然會分享，但我認為我們不能在現階段做出承諾，因為我們還沒有看到數據。

Our next question comes from Hartaj Singh with Oppenheimer.

我們的下一個問題來自哈塔吉·辛格和奧本海默。

Great. I just have a question on -- you're developing a refrigerator stable vaccine and flu vaccine, I believe. And I'd just like to kind of understand how you think about that. When could that get approved? And then will the combo vaccine also be refrigerator stable?

偉大的。我只是有一個問題——我相信你們正在開發一種冰箱穩定的疫苗和流感疫苗。我只是想了解一下您對此有何看法。什麼時候可以批准？那麼組合疫苗在冰箱中也能穩定嗎？

Great. (inaudible)

偉大的。 （聽不清楚）

(technical difficulty) Ladies and gentlemen, please stand by, your conference will resume momentarily. Once again, ladies and gentlemen, please stay on the line.

（技術難度）女士們、先生們，請稍候，您的會議即將恢復。再次強調，女士們先生們，請保持通話。

And pardon me, can you all hear me now? Could you try speaking again? Your line was muted.

請原諒，你們現在聽得到我說話嗎？你能再試著說話嗎？你的線路被靜音了。

Yes, I'm here. Can you hear me?

對，我在這。你聽得到我嗎？

Yes, we can hear you now. So your line got muted, but you can go ahead and continue.

是的，我們現在可以聽到你的聲音。因此您的線路已靜音，但您可以繼續。

Right. Sorry for that brief interruption. So Hartaj, thank you for the question. Just to quickly restate what I was saying. The -- all of our respiratory portfolio, RSV, flu, COVID and the flu COVID combo are being developed towards refrigerator stable PFS. And so our mRNA-1083 program, the flu COVID program as well as the flu program are intended to be a refrigerator stable prefilled syringes. As Stéphane mentioned a moment ago, we really view that as the ideal presentation, the helpful presentation for health care providers really around the world to facilitate their delivery of the vaccine to patients.

正確的。抱歉這麼短暫的打擾。 Hartaj，謝謝你的提問。只是為了快速重申我所說的話。我們所有的呼吸產品組合、RSV、流感、COVID 和流感 COVID 組合都正在朝著冰箱穩定的 PFS 方向發展。因此，我們的 mRNA-1083 計畫、流感 COVID 計畫以及流感計畫旨在成為冰箱穩定的預充式註射器。正如 Stéphane 剛才提到的，我們確實認為這是理想的演示，對世界各地的醫療保健提供者有幫助的演示，以方便他們向患者提供疫苗。

Our next question comes from Gena Wang with Barclays.

我們的下一個問題來自巴克萊銀行的 Gena Wang。

I have two. One is regarding COVID. So for the EU, you said up to 36 million doses every year in EU. What could be the scenario you can get 36 million doses in EU? And also the price in Brazil and the EU, should we use pandemic price of $25 to $30 per doses at the benchmark?

我有兩個。一是關於新冠疫​​情。那麼對於歐盟，你說歐盟每年有多達 3,600 萬劑疫苗。在什麼情況下您可以在歐盟獲得 3600 萬劑疫苗？還有巴西和歐盟的價格，我們是否應該以每劑25至30美元的流行病價格為基準？

Quickly on R&D, accelerated approval path. Based on, say, today's comments and the prior discussion, our impression is you could achieve all the 3 key components by the end of this year. Is Merck is also fully on board to submit for the accelerated approval in melanoma?

快速研發，加速審核路徑。根據今天的評論和先前的討論，我們的印像是您可以在今年年底之前實現所有 3 個關鍵組件。默克公司是否也完全同意提交黑色素瘤的加速核准申請？

Gena. It's Stéphane. I'll take the COVID question and then Stephen will talk about INT. So the tender is up to 36 million doses, will depend on a number of countries that apply to the tender through the EU. So this, we'll know at the end of the process. And as it's a tender process so there is no dialogue, we're just entering all the files and all the data, and that's really ongoing. The team is obviously very active on it.

吉納。這是史蒂芬。我將回答有關新冠肺炎的問題，然後史蒂芬將談論 INT。因此此次招標最多為3,600萬劑，將取決於有多少國家透過歐盟申請招標。所以，我們會在流程結束時知道這一點。由於這是一個招標過程，所以沒有對話，我們只是輸入所有文件和所有數據，這實際上是持續進行的。團隊顯然對此非常積極。

And on price, for obvious competitive reasons, we're not going to share price in any market to -- because competitors will know the price right away. Stephen, INT?

在價格方面，出於明顯的競爭原因，我們不會在任何市場上公開股價，因為競爭對手會立即知道價格。史蒂芬，INT？

Yes. So we haven't specifically guided to when we expect to complete, obviously, the second and third parts of our 3-part criteria. That being manufacturing readiness, as you can imagine, work is going on around the clock as well as the enrollment we've made great progress, but we have to sustain that progress.

是的。因此，我們沒有具體指導我們預計何時完成我們的三部分標準的第二部分和第三部分。正如你可以想像的那樣，生產準備工作正在全天候進行，我們在招生方面也取得了很大進展，但我們必須維持這種進展。

On your question of where is Merck on this. I think you'll have to direct it to them. Our view is that if we're able to get to the point where ancillary approval is appropriate and regulators are supportive of that, we can't imagine why ourselves and Merck wouldn't want to make the product available to help people suffering from cancer right now.

關於你的問題，默克公司對此有何看法？我想你必須把它交給他們。我們的觀點是，如果我們能夠達到適當的輔助批准並且監管機構支持這一點，我們無法想像為什麼我們自己和默克不想讓該產品幫助癌症患者現在。

But the contingencies, there are, obviously, we have to do our work and our doses this year. And then ultimately, we have to speak to regulators, and they get to decide whether that pathway is available to us. And so I think for both ourselves and our partner Merck, we want to defer to regulators ultimately on that choice.

但顯然，今年我們必須做好我們的工作，做好我們的工作。最終，我們必須與監管機構交談，他們可以決定我們是否可以使用這條途徑。因此，我認為對於我們自己和我們的合作夥伴默克來說，我們最終希望遵從監管機構的選擇。

Our next question comes from Luca Issi with RBC Capital.

我們的下一個問題來自 RBC Capital 的 Luca Issi。

Maybe a very quick one on RSV. I think the last press release actually cited May 12 as the PDUFA date. While today, you're simply saying the initial regulatory approvals in the first half of '24. So is there anything to read to it? Can you just confirm that the PDUFA date is still May 12, which is actually the end of next week?

也許 RSV 上的一個非常快的。我認為上一份新聞稿實際上引用了 5 月 12 日作為 PDUFA 日期。而今天，您只是說 24 年上半年的初步監管批准。那麼有什麼可以讀的嗎？您能否確認一下 PDUFA 日期仍然是 5 月 12 日，實際上是下週末？

And then maybe second, on IP, can you just comment on the recent decision by Judge Goldberg to rule out, obviously, (inaudible) or you're looking on a particle. Our understanding, this can have pretty material impact on both prior and future sales of COVID. So again, any thoughts there, much appreciated.

然後，也許第二，在智慧財產權方面，您能否評論一下戈德伯格法官最近做出的排除決定，顯然，（聽不清楚）或您正在尋找一個粒子。據我們了解，這可能會對新冠病毒之前和未來的銷售產生相當大的重大影響。再次強調，非常感謝您的任何想法。

And then super quickly on INT. Stephen, what's holding you back on starting the randomized trial intended to cancer into metastatic static? I thought the data they see that was pretty impressive. So any thoughts there, much appreciated.

然後在 INT 上速度非常快。史蒂芬，是什麼阻礙您開始針對轉移性癌症的隨機試驗？我認為他們看到的數據非常令人印象深刻。因此，非常感謝那裡的任何想法。

Great. Perfect question. I'll take this first from the third very quickly. So on the function of RSV, we continue working towards the same PDUFA date, and there's no change to that. As you know, there's a lot of work and around the clock work by ourselves, obviously, and folks at the agency.

偉大的。完美的問題。我很快就會從第三個開始講第一個。因此，在 RSV 功能上，我們繼續努力爭取相同的 PDUFA 日期，並且沒有任何變化。如您所知，我們自己以及該機構的人員顯然有很多工作需要全天候工作。

And so we're hopeful that, that happens as planned, but if it takes a little bit longer, at the end of the day, what really matters is the duty for (inaudible) meeting, but there's been no change to report. So don't read anything into that.

因此，我們希望這會按計劃發生，但如果需要更長的時間，最終，真正重要的是（聽不清楚）會議的職責，但沒有任何變化需要報告。所以不要讀任何內容。

As far as the INT question, on head and neck, I appreciate the question because we are also obviously enthusiastic about that data. However, our partner, Merck and ourselves, we have not yet decided where that fits in the priority of other indications, pathologies and opportunities we're pursuing.

至於頭部和頸部的 INT 問題，我很欣賞這個問題，因為我們顯然也對這些數據充滿熱情。然而，我們的合作夥伴默克公司和我們自己尚未決定這與我們正在尋求的其他適應症、病理和機會的優先順序相符。

As you've already seen in the past year, we've stood up a very large number of study. And we're just trying to pace ourselves. And so it will take us a little bit of time with our partner, Merck, to determine what the next steps are in head and neck. And at this point, we do not have an update on.

正如您在過去一年中已經看到的那樣，我們進行了大量的研究。我們只是想調整自己的步調。因此，我們需要與我們的合作夥伴默克公司一起花一些時間來確定頭部和頸部的下一步措施。目前，我們還沒有更新。

And I'll take the IP questions. I mean as you know, our COVID-19 vaccine technology, including our lipid nanoparticle delivery system is the result of independent research and development. We have a strong belief that our technology does not impact on the patent asserted by (inaudible). We are confident in our position, and we look forward to presenting our case after next year.

我將回答智慧財產權問題。我的意思是，如您所知，我們的 COVID-19 疫苗技術，包括我們的脂質奈米顆粒遞送系統是自主研發的結果。我們堅信我們的技術不會影響（聽不清楚）所主張的專利。我們對自己的立場充滿信心，並期待在明年之後展示我們的案例。

Our next question comes from Jessica Fye with JPMorgan.

我們的下一個問題來自摩根大通的傑西卡·菲伊。

I had a few here. So for INT, I know you mentioned you can't comment on when you expect to complete the manufacturing scale up. But can you provide a status update on where you stand with that today, and the number of patients you can support right now as well as where you want to take that capacity once you get to the end of this 3-phase scale-up process, even if you don't put a timeline on when you'll get there?

我這裡有幾個。因此，對於 INT，我知道您提到您無法評論預計何時完成生產規模擴大。但是，您能否提供一個最新狀態，說明您目前的情況、您現在可以支持的患者數量，以及在這個三階段擴展過程結束後您希望將這些能力用於何處，即使您沒有給出到達目的地的時間表？

Next one is coming back to flu. Can you just refine a little bit when the 1083 immunogenicity data will be available? And maybe elaborate on how the combo data play a role in the regulatory talks on 1010. I thought you previously said these products could stand on their own. And that you might not need 1010 approved to get 1083 approval. So now wondering kind of why 1083 might factor in for 1010.

下一場是流感。當 1083 免疫原性資料可用時，您能稍微完善一下嗎？也許還可以詳細說明組合數據如何在 1010 的監管談判中發揮作用。並且您可能不需要 1010 批准即可獲得 1083 批准。現在想知道為什麼 1083 可能會包含在 1010 中。

And then lastly, on CMV, can you remind me how the risk of CMV and pregnancy compares in seropositive versus seronegative individuals. I'm thinking from a commercial standpoint, how you weigh the strategy of pursuing vaccinating everyone versus just seronegative people.

最後，關於 CMV，您能否提醒我，血清陽性個體與血清陰性個體的 CMV 和懷孕風險有何比較。我從商業角度思考，如何權衡為所有人接種疫苗和只為血清陰性人群接種疫苗的策略。

Great. I'll start with the INT question on manufacturing, then Stephen can add around (inaudible). So we have not provided some capacity numbers of the factory in Marlborough. But of course, as you can assume, we now the size of melanoma market. And we know our stronger data. We (inaudible) people benefiting from the Phase II data.

偉大的。我將從有關製造的 INT 問題開始，然後史蒂芬可以補充（聽不清楚）。所以我們沒有提供馬爾堡工廠的一些產能數據。但當然，正如您可以想像的那樣，我們現在黑色素瘤市場的規模。我們知道我們的數據更強大。我們（聽不清楚）人們受益於第二階段的數據。

So we've sized the plant accordingly, as you can imagine. But also, we are building the plant for care because, as you know, Stephen and his team and his colleagues are running a lot of studies. So this is not a platform in (inaudible) a plant for INT. Again, from a manufacturing standpoint, we don't care which cancer is in terms of organ because we use genetic information to design an individual product for every human being.

因此，正如您可以想像的那樣，我們相應地調整了工廠的大小。而且，我們正在建造護理工廠，因為如您所知，史蒂芬和他的團隊以及他的同事正在進行大量研究。所以這裡不是 INT 工廠（聽不清楚）的平台。同樣，從製造的角度來看，我們並不關心哪種癌症是器官方面的，因為我們使用遺傳資訊為每個人設計單獨的產品。

So basically, we bought a plant last year that was kind of -- is a big building finished, saves us time to market. Obviously, we don't have to get the permitting and build the building. And so the team since then, that is now more than a year ago, has been working actively to get the plant ready.

所以基本上，我們去年買了一座工廠，就像一棟大型建築完工了，節省了我們上市的時間。顯然，我們不必獲得許可並建造建築物。因此，從那時起，也就是一年多前，該團隊一直在積極工作，為工廠做好準備。

And the plant is on the building in modules inside the building. So basically, we're going to launch with the first module of manufacturing capacity. And then -- and one day maybe we do an opening of a facility like we did for (inaudible). You will see that there's another empty space left behind, which has also a very quick ramp-up because the HVAC system and all utility system has been set up for the entire plant. And so then you just add modules as you go. So we'll be able to scale very quickly as we get more indication available.

工廠位於建築物內的模組中。所以基本上，我們將推出第一個製造能力模組。然後——有一天，也許我們會像我們以前那樣開設一個設施（聽不清楚）。您會看到剩下另一個空的空間，它也有一個非常快速的提升，因為整個工廠的 HVAC 系統和所有公用系統都已經設定好了。然後您只需添加模組即可。因此，當我們獲得更多可用指示時，我們將能夠非常快速地擴展規模。

But again, we're aware of the melanoma number of cases. And so the plant will be sized so we make sure we can provide products to patients. Stephen?

但我們再次意識到黑色素瘤的病例數。因此，我們將調整工廠的規模，以確保我們能夠為患者提供產品。史蒂芬？

Thank you for the clarifying question on flu. So let me just start by saying that independently, we are looking to submit both the flu program and the flu COVID combo program. So that's 1010 and 1083. Obviously, we need to see the 1083 data, and we'll announce that when we have it.

感謝您澄清有關流感的問題。首先我要說的是，我們希望獨立提交流感計劃和流感新冠組合計劃。這就是 1010 和 1083。

The question on the timing of that data, it's imminent. And so in the coming quarter, we expect to be able to share that update. The point about interdependency, I suppose, is just more about sequencing of those submissions and in some places and some regulatory geographies, obviously, you can't stack them on the same day if you will. There's a logical sequence.

關於該數據的時間問題迫在眉睫。因此，在下個季度，我們預計能夠分享該更新。我認為，關於相互依賴性的要點更多地在於這些提交的順序，在某些地方和某些監管地區，顯然，如果您願意，您不能將它們堆疊在同一天。有一個邏輯順序。

And what we want to assess once we see the 1083 data is our regulatory strategy as well as our preparation and delivery of data for the submissions to determine which one will go first or second. But at this point, we're trying hard to make sure that we can do both products across all of our major markets, if the data is filed in this year.

一旦我們看到 1083 數據，我們想要評估的是我們的監管策略以及我們為提交數據準備和交付的情況，以確定哪一個將排在第一或第二。但目前，如果數據在今年提交，我們正在努力確保我們可以在所有主要市場上生產這兩種產品。

And so we'll go more on that as we move forward. But for now, we are proceeding without independently. Sorry for the confusion model.

因此，隨著我們的前進，我們將在這方面做更多的工作。但目前，我們還沒有獨立進行。抱歉模型混亂。

On the question of CMV and seropositivity. So it's a really important point. Thank you for raising it. But while the majority -- well, the risk of vertical transmission of CMV to pregnancy to the fetus is highest in seronegative. It does happen in seropositives as well. So congenital CMV is a disease that's seen in -- particularly in reactivation or sometimes reinfection, even in the seropositive context. And so we do believe that there's a potential for benefit for a vaccine even in seropositive population.

關於CMV和血清陽性的問題。所以這是非常重要的一點。謝謝你提出來。但是，儘管大多數——嗯，鉅細胞病毒通過妊娠垂直傳播給胎兒的風險在血清陰性的情況下最高。它也確實發生在血清陽性者中。因此，先天性鉅細胞病毒是一種常見疾病，特別是在重新活化或有時重新感染的情況下，甚至在血清反應呈陽性的情況下也是如此。因此，我們確實相信，即使在血清反應呈陽性的人群中，疫苗也有可能帶來益處。

We are evaluating the study right now in seronegative because the rate of that transmission and obviously, the potential to prevent against infection is more enriched and therefore the study size, primary are focused on seronegatives.

我們現在正在血清陰性情況下評估這項研究，因為傳播率以及預防感染的潛力顯然更加豐富，因此研究規模主要集中在血清陰性情況。

But we are looking. We have studied the vaccine from a safety perspective in seropositives. And we are looking at things like [Sheng]. If you draw a little bit of an analogy to correlate to the EVB data that we've already put out there in a different virus, but we've been able to show that we can really control the rate setting even in seropositives (inaudible) qualifiers.

但我們正在尋找。我們從血清陽性的安全角度研究了該疫苗。我們正在研究像[盛]這樣的事情。如果你做一點類比來與我們已經在不同病毒中發布的 EVB 數據相關聯，但我們已經能夠證明，即使在血清陽性情況下，我們也可以真正控制速率設定（聽不清楚）預選賽。

And so we have some reasons for optimism and believe that when we pull together the totality of the data, there will both be the obvious potential benefit, which is that there is still vertical transmission in seropositives and some -- potentially some data on the rate of (inaudible) that would be supportive to that.

因此，我們有一些樂觀的理由，並相信，當我們匯總全部數據時，都會有明顯的潛在好處，即血清陽性仍然存在垂直傳播，以及一些可能的比率數據（聽不清楚）這將支持這一點。

Ultimately, though, we're studying all the way down to 16-year-olds. And our goal will be a label that 16 plus, with the goal going into a population that is not as highly seropositive as it is later in life and therefore, we see a very large opportunity, improvement, and then primary infection CMV with the vaccine and the potential for (inaudible) seropositives (inaudible).

但最終，我們的研究對像一直是 16 歲。我們的目標將是 16 歲以上的標籤，目標是進入一個不像晚年那樣高度血清陽性的人群，因此，我們看到一個非常大的機會、改善，然後用疫苗進行原發性感染 CMV以及（聽不見清）血清陽性的可能性（聽不清楚）。

Our next question comes from Geoff Meacham with BofA.

我們的下一個問題來自美國銀行的傑夫‧米查姆 (Geoff Meacham)。

This is Alex Hammond for Geoff Meacham. So on your [zoster] vaccine candidate, when should we receive updates on your pivotal strategy? And is there any color you can provide today in terms of your current thinking on the Phase III design?

我是傑夫·米查姆的亞歷克斯·哈蒙德。那麼，關於您的[帶狀皰疹]候選疫苗，我們什麼時候應該收到您的關鍵策略的更新？就您目前對三期設計的想法而言，您今天能提供什麼顏色嗎？

And then our second question is on the PA and MMA programs that are advancing into pivotal trials, can you provide any thoughts on the nature of editorial and the comments on safety?

然後我們的第二個問題是關於正在進入關鍵試驗的 PA 和 MMA 項目，您能否就社論的性質和安全評論提供任何想法？

Yes. Could you describe about the first part of the question was on which program? The zoster?

是的。您能描述一下問題的第一部分是關於哪個程式的嗎？帶狀皰疹？

The zoster, the shingle.

帶狀皰疹，帶狀皰疹。

Shingle zoster. So on the (inaudible) program, we have -- we're obviously very excited by the Phase I data, which was compared against a licensed product, and we saw really strong T cell response in immunogenicity. And generally, we've been in that across our programs. But in that one, it was very encouraging.

帶狀皰疹。因此，在（聽不清楚）計劃中，我們顯然對 I 期數據感到非常興奮，該數據與許可產品進行了比較，我們看到了非常強烈的免疫原性 T 細胞反應。總的來說，我們的所有項目都在這樣做。但在那一件事上，這是非常令人鼓舞的。

We're in the process right now of trying to find the pivotal strategy. That will include, obviously, dose selection, the number of doses in that study and then how we're going to expect that study.

我們現在正在努力尋找關鍵策略。顯然，這將包括劑量選擇、該研究中的劑量數量以及我們將如何預期研究。

We do not have an update till today on what that will look like in addition to our own thoughts on it, we obviously want to consult with regulators before we finalize that (inaudible). But we are moving for forward -- towards a pivotal study in PCV. We do not have a (inaudible) on that update yet.

直到今天，除了我們自己的想法之外，我們還沒有關於具體情況的更新，我們顯然希望在最終確定之前諮詢監管機構（聽不清楚）。但我們正在向前邁進——進行 PCV 的關鍵研究。我們還沒有（聽不清楚）該更新。

As it relates to MMA and PA, the clinical data that we have continues to show a compelling benefit risk profile, good safety profile. In fact, in the PA studies, we have many folks who've been in those -- in the study on drug for well over a year. And over 30 years, I think, from our last update in overall patient dosing experience.

由於它與 MMA 和 PA 相關，我們擁有的臨床數據繼續顯示出令人信服的益處風險概況和良好的安全概況。事實上，在 PA 研究中，我們有許多人已經從事藥物研究一年多了。我想，距離我們上次更新患者整體用藥經驗已經 30 多年了。

So we are starting to get a very clear perspective on the safety profile. The editorial question, I don't have a view on editorials or opinions based on the preclinical data. I think we stand behind the clinical data that we have and are quite encouraged by that profile, and we'll continue to watch it closely in our ongoing Phase I studies, but we do not have any specific or new concerns based on the clinical data today.

因此，我們開始對安全狀況有一個非常清晰的認識。編輯問題，我對基於臨床前數據的社論或意見沒有看法。我認為我們支持我們所擁有的臨床數據，並且對該情況感到非常鼓舞，我們將在正在進行的第一階段研究中繼續密切關注，但根據臨床數據，我們沒有任何具體或新的擔憂今天。

Our next question comes from Evan Wang with Guggenheim Securities.

我們的下一個問題來自古根漢證券公司的 Evan Wang。

Two for me. First, on the combo 1083 program, so data, it sounds like this quarter, I believe enrollment was completed a few months ago. So I guess how comprehensive will the top line update be in terms of follow-up? And then with submission, is longer-term vault needed there? And are there parallels from 1010 that we can take in terms of regulatory filing speed for 1083? Or is that more impacted by the decision for buying one or the other first?

給我兩個。首先，關於組合1083計劃，所以數據，聽起來像是這個季度，我相信幾個月前就完成了註冊。那我猜頂線更新在後續方面會有多全面呢？然後提交後，是否需要長期保管庫？ 1083 的監管申請速度與 1010 有何相似之處？或者說，這是否受到先購買其中一個或另一個的決定的影響更大？

And then second, on RSV, it's kind of early ahead of approval, but with some international markets, it seems that's more nascent in terms of established some reimbursement there. So I guess how are you thinking about positioning internationally?

其次，就 RSV 而言，它在批准之前有點早，但對於一些國際市場來說，就在那裡建立一些報銷而言，這似乎更為新生。那我想您如何考慮國際定位？

Great. So for the 1083 data, yes, on this quarter, and I would say that we're -- we enrolled the majority of the 1083 studies you know last fall. And the 1010 second-generation study. So we talked about the P303 study. The first part of that enrolled over last summer, just a few months before the combo study.

偉大的。因此，對於 1083 項數據，是的，在本季度，我想說的是，我們去年秋天登記了您知道的 1083 項研究中的大部分。還有1010二代學習。所以我們討論了 P303 研究。第一部分是在去年夏天註冊的，就在組合研究前幾個月。

And the second part of it, there was a part B and C, as you know, looking head-to-head against (inaudible), that actually enrolled the same time as the 1083 study last fall. And so they've been actually kind of tracking right on top of each other.

第二部分，如你所知，有 B 部分和 C 部分，針鋒相對（聽不清楚），實際上與去年秋天的 1083 研究同時註冊。所以他們其實是在互相跟蹤。

I think we're going to wait to see the data before we can provide growth guidance on timing. But obviously, we're -- we've been working towards that flu COVID combination product for a while, and we will want to make sure that we get that filed, if it is positive as fast as possible.

我認為我們將等待看到數據，然後才能提供有關時機的成長指導。但顯然，我們已經致力於開發流感新冠組合產品一段時間了，如果結果呈陽性，我們將希望確保盡快提交該產品。

I wouldn't draw too many, because of the difference in the structures of the study between the P303 study, which has a part A and the B and a C, and the 1083 study, which was done very quickly. I wouldn't draw too many correlations between (inaudible) reading out and the timing for submission on (inaudible).

我不會畫太多，因為 P303 研究（有 A 部分、B 部分和 C）和 1083 研究（完成得很快）之間的研究結構有所不同。我不會在（聽不清楚）讀出和提交（聽不清楚）的時間之間畫出太多的相關性。

Stéphane, do you want to take the RSV question?

Stéphane，您想回答 RSV 問題嗎？

Sure. So with internal markets, obviously, very important, the U.S. is very important, the U.S. and Russia also super important. As we shared before, we found in all the major geographies already. Of course, EU, U.K., Canada, Australia, some countries in Asia, some countries in the Middle East.

當然。因此，對於內部市場來說，顯然非常重要，美國非常重要，美國和俄羅斯也非常重要。正如我們之前分享的，我們已經在所有主要地區發現了這一點。當然還有歐盟、英國、加拿大、澳洲、亞洲的一些國家、中東的一些國家。

RSV is well known by public health leaders like it is in the U.S. So I think that there's a very strong desire, again, to protect the elderly or what we are doing here in terms of true COVID RSV, that's becoming very kind of a standard that probably (inaudible) across at least the developed world. But even in developing countries, there's more and more interest as you see aging population everywhere.

RSV 被公共衛生領導人所熟知，就像在美國一樣。在已開發國家可能（聽不清楚）。但即使在發展中國家，隨著各地人口老化，人們的興趣也越來越濃厚。

So it's not only the U.S. approval that we expect coming soon is we have several geographies that would start being approved so.

因此，我們預計不僅美國會很快獲得批准，我們還有幾個地區也將開始獲得批准。

Our next question comes from Simon Baker with Redburn Atlantic.

我們的下一個問題來自 Redburn Atlantic 的 Simon Baker。

Two quick ones, if I may. Just in terms of the timing on the CMV interim data. You said this quarter, it could be as early as the end of '24. That sounds slightly later than you previously said. I just wondered if that's me over-interpreting the semantics or whether there is a slight delay there?

如果可以的話，兩個快點。就 CMV 中期資料的時間而言。你說這個季度，最快可能是 24 年底。這聽起來比你之前說的要晚一些。我只是想知道是否是我過度解釋了語義，或者是否存在輕微的延遲？

And then the second question is on the HSV vaccine. Previous quarters, we talked about the EBV vaccine and the potential utility in multiple sclerosis. So I just wondered what your thoughts were about HSV and it's the hypothesis that implicates it's role in Alzheimer's disease?

第二個問題是關於HSV疫苗的。前幾個季度，我們討論了 EBV 疫苗及其在多發性硬化症中的潛在用途。所以我只是想知道你對 HSV 有何看法？

So first on the clarification. There's no change to our expectations on when the CMV readout will happen. I think we previously tried to be careful in saying that we expect it to happen this year. And so obviously, by the end of this year, it is meant to say the same thing, but there's no change in our expectations at this point.

首先澄清一下。我們對 CMV 讀數何時發生的預期沒有改變。我認為我們之前曾試圖謹慎地說我們預計今年會發生這種情況。顯然，到今年年底，它的意思是相同的，但此時我們的期望並沒有改變。

On the HSV Alzheimer's hypothesis, it's a very interesting -- there's a lot of neuroinflammatory questions that go with the herpes simplex virus infection across a range of different mutations, Alzheimer's one of them.

關於單純皰疹病毒阿茲海默症的假說，這是一個非常有趣的問題——有許多神經發炎問題與一系列不同突變的單純皰疹病毒感染有關，阿茲海默症就是其中之一。

At this point, the studies that we expect to move forward with HSV will be for seropositive to improve outcomes. So shedding days, for instance, or lesion based, and then eventually, we will want to consider whether we want to go at prevention of infection, which is obviously a different standard of different indication. That might be more relevant for them, how you think about some of the neuroinflammatory or long-term supply.

目前，我們預期針對單純皰疹病毒進行的研究將針對血清陽性以改善結果。因此，例如脫落天數，或基於病變的，然後最終，我們要考慮是否要預防感染，這顯然是不同適應症的不同標準。這可能與他們更相關，你如何看待一些神經發炎或長期供應。

I think you asked my opinion on the -- I think it's incredibly interesting and exciting. I do think it's early for us to start drawing connection from a vaccine perspective in terms of our potential impact for it. I hope over time, there is an opportunity to intervene and things like that.

我想你問了我對這個問題的看法——我認為這非常有趣和令人興奮。我確實認為我們現在開始從疫苗的角度來了解我們對其的潛在影響還為時過早。我希望隨著時間的推移，有機會進行幹預之類的事情。

Obviously, in the EBV vaccine with multiple sclerosis, that science has firmed up to the point where there's reasonably high conviction that there's a potential for benefit there. We have to go prove that. But at this point, it's still earlier days, I think, with HSV and Alzheimer's.

顯然，對於治療多發性硬化症的 EBV 疫苗，科學已經證實了這一點，人們相當確信該疫苗具有潛在的益處。我們必須去證明這一點。但我認為，就目前而言，單純皰疹病毒和阿茲海默症還處於早期階段。

Our next question comes from Edward Tenthoff with Piper Sandler.

我們的下一個問題來自愛德華·滕托夫和派珀·桑德勒。

Congrats on everything. Actually, most of my questions have been answered. But I wanted to ask with respect to the cancer efforts, are you able to break out what the actual R&D cost is for that program and that's still a cause some profit share with Merck? And how many indications do you guys ultimately plan on pursuing?

祝賀一切。其實我的大部分疑問都已經得到解答了。但我想問關於癌症方面的努力，您是否能夠透露該項目的實際研發成本是多少，並且這仍然是與默克公司分享一些利潤的原因？你們最終計劃追尋多少跡象？

Maybe I'll take the first one, Ed. So we obviously know what we're spending, (inaudible) but at this point, that we are not prepared to disclose. So maybe someday, but not at this time.

也許我會選擇第一個，艾德。因此，我們顯然知道我們的支出（聽不清楚），但目前我們不準備透露。所以也許有一天，但不是現在。

Understood. And then -- with the expansion...

明白了。然後——隨著擴張…

Yes. On the expansion indication. Look, at the joint decision, our partnership with Merck has been really strong. We've been building this out. We do like to review those strategically and then bring them forward once we've started them. And so I don't want to get ahead of that because those are our private strategic competition with Merck. But we are not done yet. We will keep adding in the years ahead.

是的。關於擴充指示。看，從聯合決定來看，我們與默克的合作關係非常牢固。我們一直在建立這個。我們確實喜歡從策略上審查這些內容，然後在開始後將其推進。所以我不想提前，因為這是我們與默克公司的私人策略競爭。但我們還沒完成。我們將在未來幾年繼續增加。

Very exciting. Look forward to seeing you in Chicago.

非常令人興奮。期待在芝加哥見到您。

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

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 Stéphane，讓其結束語。

Well, thank you, everybody, for joining in today for a great session. We look forward to seeing you at latest ASCO. Have a great day.

好的，謝謝大家參加今天的精彩會議。我們期待在最新的 ASCO 展會上見到您。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。