莫德納 (MRNA) 2024 Q3 法說會逐字稿

Good day, and thank you for standing by.

美好的一天，感謝您的支持。

Welcome to the Moderna third-quarter 2024 conference call.

歡迎參加 Moderna 2024 年第三季電話會議。

(Operator Instructions) Please be advised today's conference is being recorded.

（操作員指示）請注意，今天的會議正在錄製中。

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

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)。

Please go ahead.

請繼續。

Thank you, Kevin.

謝謝你，凱文。

Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's third-quarter 2024 financial results and business updates.

大家早安，感謝您參加今天的電話會議，討論 Moderna 的 2024 年第三季財務業績和業務更新。

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.

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 that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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。

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.

請參閱隨附簡報的投影片 2 以及我們向 SEC 提交的文件，以了解可能導致我們的實際業績和結果與這些前瞻性聲明中明示或暗示的內容有重大差異的重要風險因素。

I will now turn the call over to Stéphane.

我現在將把電話轉給 Stéphane。

Thank you, Lavina.

謝謝你，拉維娜。

Good morning or good afternoon, everyone.

大家早安或下午好。

Thank you for joining us.

感謝您加入我們。

I will start with a review of our business in the third quarter.

我將從第三季的業務回顧開始。

Jamey will present our financial results and outlook.

Jamey 將介紹我們的財務表現和前景。

Stephen will review our clinical programs.

史蒂芬將審查我們的臨床計劃。

I will then come back and share our key priorities before Q&A.

然後我將在問答之前回來分享我們的主要優先事項。

We delivered $1.9 billion of revenue in the third quarter.

第三季我們實現了 19 億美元的營收。

Our net income was $13 million.

我們的淨利潤為 1300 萬美元。

We ended the quarter with cash and investments of $9.2 billion.

本季結束時，我們的現金和投資為 92 億美元。

As you know, for over a year now, we have been working to improve productivity in the company.

如您所知，一年多來，我們一直致力於提高公司的生產力。

In the third quarter of 2024 compared to the first quarter of 2023, we reduced operating expenses by $500 million across cost of sales, RD and SG&A.

與 2023 年第一季相比，2024 年第三季度，我們在銷售、研發和銷售成本、SG&A 方面的營運費用減少了 5 億美元。

This figure excludes $1.4 billion of resizing charge in the first quarter of 2023.

該數字不包括 2023 年第一季 14 億美元的規模調整費用。

I would like to thank our teams who have been working hard to achieve these cost savings and we'll continue our journey to improve our cost efficiencies.

我要感謝我們的團隊，他們一直在努力實現這些成本節約，我們將繼續努力提高成本效率。

This year, the COVID market benefited from US regulatory approval that was 19 days earlier than in 2023.

今年，新冠病毒市場受益於美國監管機構的批准，比 2023 年提早了 19 天。

Spikevax was available across all segments of the US health care system.

Spikevax 可用於美國醫療保健系統的所有部門。

For manufacturing and logistics teams were able to double the number of doses delivered to customers compared to the first week of last year's COVID vaccine season.

與去年新冠疫苗季第一週相比，製造和物流團隊能夠將交付給客戶的疫苗數量增加一倍。

Now turning to what we have seen so far this season for vaccinations in the US retail market.

現在轉向我們本季迄今在美國零售市場上看到的疫苗接種情況。

The graphs on slide 6 are shots in arms in the retail channels as measured by IQVIA, which includes retail pharmacies and long-term care.

第 6 張投影片上的圖表是 IQVIA 衡量的零售通路的強心劑，其中包括零售藥局和長期照護。

As you can see the graph on the left, the earlier approval of a vaccine this year has helped to push total market vaccine dose above where they were last year at this point in the season.

如左圖所示，今年疫苗的早期批准有助於將市場疫苗總劑量推至去年季節此時的水平之上。

The graph on the right shows weekly doses, which, as you can see in the past few weeks have started to decline.

右圖顯示了每週的劑量，正如您所看到的，在過去的幾周里，劑量已經開始下降。

While we will not know the shape of this curve until the end of the season, we are encouraged that the COVID market is starting to prove to be a sizable and durable long-term market.

雖然我們要到本季結束才能知道這條曲線的形狀，但我們感到鼓舞的是，新冠病毒市場開始被證明是一個規模龐大且持久的長期市場。

Moderna has 40% share of retail shops in arms season to date.

迄今為止，Moderna 在軍火季節擁有 40% 的零售商店份額。

Turning to slide 7.

轉到投影片 7。

We think it is helpful to look at vaccination trends from last year to inform our understanding of where there are additional opportunities to grow the COVID market.

我們認為，了解去年的疫苗接種趨勢有助於我們了解哪些領域還有更多機會來發展新冠病毒市場。

There are three major delivery channels for respiratory vaccines in the US.

美國呼吸道疫苗有三個主要輸送管道。

There are retail pharmacies, integrated delivery networks, or IDNs, which basically serve hospitals and doctors who are part of these networks and the third group, government programs and other.

有零售藥局、綜合配送網路或 IDN，它們基本上為屬於這些網路的醫院和醫生以及第三組、政府專案和其他機構提供服務。

As you can see, the retail channel comprised 73% of total US market for COVID vaccine doses last year in 2023.

如您所見，2023 年零售通路占美國新冠疫苗劑量市場總量的 73%。

COVID vaccines have been overwhelmingly given to pharmacy settings with such smaller distribution into other channel.

新冠疫苗絕大多數被提供給藥房，而分配到其他管道的比例則較小。

If now we look at flu.

現在我們來看看流感。

In the flu market, however, the distribution by channel is different with much greater emphasis on IDN and government.

然而，在流感市場，按通路的分配有所不同，更加重視 IDN 和政府。

Since COVID started to present a much greater health burden than flu in the United States, we remain convinced that increasing the vaccination rate of COVID relative to flu provides a significant opportunity to improve public care, especially in the IDN segment and government and other segments.

由於新冠肺炎在美國開始造成比流感更大的健康負擔，我們仍然相信，相對於流感而言，提高新冠肺炎疫苗接種率可以為改善公共護理提供重要機會，特別是在IDN 領域以及政府和其他領域。

Therefore, as we execute our COVID strategy, we see the opportunity to drive the COVID vaccination rate closer to flu over time, especially in the underpenetrated channels.

因此，當我們執行新冠病毒策略時，我們看到隨著時間的推移，有機會使新冠病毒疫苗接種率接近流感疫苗接種率，特別是在滲透率較低的管道。

One additional approach to increase COVID vaccination rate over time is a combination COVID/flu vaccine, which Stephen will discuss shortly.

隨著時間的推移，提高新冠病毒疫苗接種率的另一種方法是聯合使用新冠病毒/流感疫苗，史蒂芬很快就會對此進行討論。

Let's now turn to what Moderna is doing to drive vaccination rates.

現在讓我們來看看 Moderna 正在採取哪些措施來提高疫苗接種率。

The first objective of our effort is to educate health care providers on the importance of COVID as a public health trend.

我們努力的首要目標是讓醫療保健提供者了解新冠病毒作為公共衛生趨勢的重要性。

Its negative impact has a much greater cause of severe illness than other respiratory viruses and the opportunity to improve public health by following vaccine recommendation.

與其他呼吸道病毒相比，其負面影響更容易導致嚴重疾病，並且有機會透過遵循疫苗推薦來改善公共衛生。

As you know, in the 2023, 2024 season, there were three times more hospitalization of COVID than flu.

如你所知，在 2023、2024 年季節，新冠肺炎住院人數是流感住院人數的三倍。

Secondly, we're going direct to consumer to emphasize the benefit of getting vaccinated and our most recent campaign highlights the danger of a long COVID and the importance of vaccination to minimize the risk of it.

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感染新冠病毒的危險以及接種疫苗以最大程度地降低風險的重要性。

Additionally, public health authorities, including the CDC, recognized the importance of vaccination, which is reflected by the most recent AC proclamation for additional COVID doses for immunocompromised people and dose 65 and above in the sping of 2025.

此外，包括 CDC 在內的公共衛生當局認識到疫苗接種的重要性，AC 最近宣佈為免疫功能低下的人群增加新冠疫苗劑量，並在 2025 年春季接種 65 劑及以上疫苗，這反映了這一點。

Moving on to RSV.

繼續討論 RSV。

Moderna third-quarter mRESVIA sales were $10 million.

Moderna 第三季 mRESVIA 銷售額為 1,000 萬美元。

This was below expectations going into 2024.

這低於 2024 年的預期。

Unfortunately, the timing of approval and recommendation by the CDC of mRESVIA resulted in us missing most of contracting season.

不幸的是，CDC 批准和推薦 mRESVIA 的時機導致我們錯過了大部分簽約季節。

Additionally, the substantial buildup of inventory in the channel by competitors prior to our launch has had a negative impact on our sales.

此外，在我們推出之前，競爭對手在通路中大量累積庫存，對我們的銷售產生了負面影響。

Looking to 2025, we believe that we'll be able to participate from the beginning of the contracting season in the US.

展望 2025 年，我們相信我們能夠從美國的合約季節開始就參與其中。

We also filed for approval of a broader mRESVIA label that will allow to address the 18- to 59-year-old high-risk population.

我們也申請批准更廣泛的 mRESVIA 標籤，以應對 18 至 59 歲的高風險族群。

Additionally, we see the potential for market expansion if regulators recommend revaccination.

此外，如果監管機構建議重新接種疫苗，我們看到市場擴張的潛力。

And finally, we are now starting to receive approval outside the US, and we expect to have sales in those markets in 2025.

最後，我們現在開始獲得美國以外的批准，預計 2025 年將在這些市場上銷售。

I am delighted to welcome Abbas Hussain to the Moderna Board of Directors.

我很高興歡迎阿巴斯·侯賽因 (Abbas Hussain) 加入 Moderna 董事會。

Abbas has strong commercial background, which makes him a great addition to our Board.

阿巴斯擁有深厚的商業背景，這使他成為我們董事會的重要補充。

He has more than 25 years of commercial experience, more recently, as CFO of Vifor and before that as Chief Commercial Officer of GSK.

他擁有超過 25 年的商業經驗，最近擔任 Vifor 財務官，此前擔任 GSK 首席商務官。

Abbas is an ideal member to guide Moderna forward as we continue to advance our growth portfolio of products towards commercialization in the next few years.

阿巴斯是指導 Moderna 前進的理想成員，我們將在未來幾年繼續推動我們的成長產品組合走向商業化。

We very much look forward to working with Abbas in the years ahead.

我們非常期待在未來幾年與阿巴斯合作。

Finally, I'm very pleased to announce the expansion of Moderna's Executive Committee, expanding the responsibilities of two current members of the team and adding two new members to the team to help us ensure we execute our strategy and deliver on our missions to patients.

最後，我非常高興地宣布擴大 Moderna 執行委員會的規模，擴大團隊兩名現任成員的職責，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為患者履行我們的使命。

First, Stephen will expand his role to include oversight of a full commercial organization, which was previously divided between he and I. As Moderna President, Stephen is responsible for strategic across the full lifecycle of the company, Research and Development and Medical and Commercial.

首先，史蒂芬將擴大他的職責，包括監督整個商業組織，該組織之前由他和我共同負責。

Joining Moderna's Executive Committee are Rose Loughlin and Jacqueline Miller.

Rose Loughlin 和 Jacqueline Miller 加入 Moderna 執行委員會。

Rose is being promoted to Executive Vice President, Research.

羅斯將晉升為研究執行副總裁。

Jackie is being promote to our Chief Medical Officer, leading our development organization.

Jackie 即將晉升為我們的首席醫療官，領導我們的開發組織。

The promotion of Jackie and Rose to the Executive Committee is a special milestone for the company.

Jackie 和 Rose 晉升為執行委員會成員對於公司來說是一個特殊的里程碑。

This is the first time in our history that we have promoted internal talent onto the Executive Committee.

這是我們歷史上第一次提拔內部人才進入執行委員會。

It is a testament to both of these remarkable colleagues who have each spent years building and leading critical areas of the company.

這是對這兩位傑出同事的證明，他們每個人都花了數年時間建立和領導公司的關鍵領域。

And also reflect our commitment to grow and develop our internal talent at Moderna.

也體現了我們對 Moderna 內部人才成長與發展的承諾。

Tracey Franklin, our Chief Human Resource Officer will also expand her role becoming the Chief People and Digital Technology Officer.

我們的首席人力資源長 Tracy Franklin 也將擴大她的職責，成為首席人力和數位技術長。

The expansion of her role emphasized the vital integration of people, culture and digital innovation across the business.

她的職責擴展強調了整個企業中人員、文化和數位創新的重要整合。

As Tracey and the team works to scale up our business processes, they asked a question of how we should do work.

當特雷西和團隊致力於擴大我們的業務流程時，他們問了我們應該如何運作的問題。

How should we be organized between people and digital technologies, being over-the-shelf-software, AI solutions, including our own machine learning algorithm or GPT Enterprise and/or robotic solution.

我們應該如何在人與數位科技之間進行組織，成為現成的軟體、人工智慧解決方案，包括我們自己的機器學習演算法或 GPT Enterprise 和/或機器人解決方案。

I would have to thank Stephen and Tracey for their new expanded role and for their partnership over many years and many years looking forward.

我必須感謝史蒂芬和特雷西的新角色以及他們多年來和未來多年的合作關係。

And to congratulate Rose and Jackey for now being part of the company executive committee.

並祝賀羅斯和傑基現在成為公司執行委員會的一員。

With this, let me turn to James.

說到這裡，讓我轉向詹姆斯。

Thanks, Stéphane, and hello, everyone.

謝謝，Stéphane，大家好。

Today, I will provide an overview of our financial results for the third quarter and share our outlook for the remainder of 2024.

今天，我將概述我們第三季的財務業績，並分享我們對 2024 年剩餘時間的展望。

Let's start by reviewing our commercial performance, which you can follow on slide 14.

讓我們先回顧一下我們的商業表現，您可以在投影片 14 中查看。

For the third quarter of 2024, our net product sales were $1.8 billion, bringing year-to-date product sales to $2.2 billion.

2024 年第三季度，我們的產品淨銷售額為 18 億美元，使年初至今的產品銷售額達到 22 億美元。

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.

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，這些收入未包含在本投影片的數據中。

$1.2 billion of our 3Q 2024 product sales were from the US market, where we experienced an earlier launch to the 2024, 2025 season.

我們 2024 年第三季的產品銷售額中有 12 億美元來自美國市場，我們在美國市場的推出時間較早，至 2024 年、2025 年銷售季。

While our 3Q results exceeded expectations, this was 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.

雖然我們的第三季業績超出預期，但這主要是由於第三季和第四季之間的銷售時間，以及我們更新的 COVID-19 疫苗獲得 FDA 批准的支持，比去年提前了三週。

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.

我們在美國的 12 億美元銷售額中還包括約 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。

Additionally, we commenced RSV vaccine sales in Q3.

此外，我們在第三季開始銷售 RSV 疫苗。

While initial RSV 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.

雖然 RSV 最初的銷售額僅限於 1000 萬美元，但我們相信隨著時間的推移，我們將努力佔領更大的市場份額，從而實現長期成長。

International sales of $0.6 billion were in line with our expectations but lower compared to the same period in 2023, when sales benefited from the fulfillment of orders deferred from 2022.

國際銷售額為 6 億美元，符合我們的預期，但低於 2023 年同期，當時的銷售額受益於 2022 年推遲的訂單的履行。

For our full-year 2024 outlook, we are reaffirming our product sales estimate of $3 billion to $3.5 billion, which implies the 4Q product sales range of $0.8 billion to $1.3 billion.

對於 2024 年全年展望，我們重申產品銷售額預計為 30 億至 35 億美元，這意味著第四季產品銷售額範圍為 8 億至 13 億美元。

We expect our US 4Q product sales to be between $200 million and $500 million.

我們預計美國第四季的產品銷售額將在 2 億至 5 億美元之間。

The range is driven by the following three key variables.

此範圍由以下三個關鍵變數驅動。

Our Spikevax market share, which is currently tracking to approximately 40% in retail.

我們的 Spikevax 市佔率目前在零售領域約為 40%。

At this time, it's too early to call our share in IDNs and with the government.

目前，確定我們在國際化域名 (IDN) 中的份額以及政府的份額還為時過早。

Next, vaccination rates.

接下來是疫苗接種率。

Our range assumes a market size, which has COVID vaccinations flat to down 10% versus the prior year.

我們的範圍假設了一個市場規模，即新冠疫苗接種量與前一年相比持平或下降 10%。

Finally, our performance in and the ultimate size of the RSV market in 2024.

最後是我們在 2024 年 RSV 市場的表現和最終規模。

To summarize, if our retail market share remains constant at 40% and the US market finishes this 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.

總而言之，如果我們的零售市場份額保持在 40% 不變，並且美國市場在本季結束時比去年下降 10%，並且 RSV 銷量沒有增長，我們預計將處於銷售範圍的低端。

We expect our international 4Q product sales to be between $600 million and $800 million.

我們預計第四季的國際產品銷售額將在 6 億至 8 億美元之間。

We have a tighter range on our international sales as most of these sales are for contracted volume and confirmed orders.

我們的國際銷售範圍更窄，因為大部分銷售都是合約數量和確認訂單。

The final international sales amount will be dependent upon revenue recognition timing and our performance in a few specific markets.

最終的國際銷售額將取決於收入確認時間和我們在一些特定市場的表現。

Moving to slide 15, I will talk about our 3Q financial results in more detail.

轉到投影片 15，我將更詳細地討論我們的第三季財務表現。

Net product sales for Q3 were $1.8 billion, as I just discussed on the prior page.

正如我剛剛在上一頁討論的那樣，第三季的產品淨銷售額為 18 億美元。

Our cost of sales for 3Q 2024 was $514 million, representing 28% of net product sales for the quarter.

我們 2024 年第三季的銷售成本為 5.14 億美元，佔該季產品淨銷售額的 28%。

This was a 77% year-over-year decline in our cost of sales from $2.2 billion in Q3 2023.

我們的銷售成本較 2023 年第三季的 22 億美元年減了 77%。

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.

提醒一下，去年，我們採取了一項策略性措施來重組我們的製造足跡，並在 2023 年第三季記錄了 14 億美元的庫存減記、CMO 逐步減少成本和取消費用費用。

Excluding the $1.4 billion charge, cost of sales still declined by 38% year over year as we continue to make progress driving additional productivity improvements in our manufacturing operations.

除去 14 億美元的費用，隨著我們繼續推動製造業務生產力的進一步提高，銷售成本仍較去年同期下降 38%。

R&D expenses were $1.1 billion in Q3 2024, reflecting a 2% year-over-year decline from $1.2 billion last year.

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%。

We purchased a priority review voucher during the third quarter of 2024, which is included in our Q3 results.

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。

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.

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。

SG&A expenses for Q3 2024 were $281 million, representing a 36% year-over-year reduction.

2024 年第三季的銷售、管理和行政費用為 2.81 億美元，年減 36%。

This decline reflects our focus on driving cost efficiency and making targeted investments that continue to strengthen our overall productivity.

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。

I will provide further details in the following slides.

我將在下面的幻燈片中提供更多詳細資訊。

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.

我們確認第三季所得稅為 800 萬美元，比去年同期的 17 億美元大幅減少。

The decrease was largely attributable to the establishment of a $1.7 billion valuation allowance on deferred tax assets in Q3 2023.

這一下降主要歸因於 2023 年第三季針對遞延稅務資產設立了 17 億美元的估值備抵。

The valuation allowance has remained in place since its initial recognition and continues to impact our tax expense.

估價備抵自最初確認以來一直有效，並繼續影響我們的稅務費用。

Our net income for the period was $13 million, a notable improvement from the net loss of $3.6 billion recorded in Q3 2023.

我們該期間的淨利潤為 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。

Earnings per share for the quarter were $0.03, compared to a loss of $9.53 per share in the same period last year.

本季每股收益為 0.03 美元，而去年同期每股虧損 9.53 美元。

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.

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。

Moving to slide 16.

轉到投影片 16。

I want to provide additional detail on the cost reductions we are driving across the company.

我想提供有關我們在整個公司推動的成本削減的更多細節。

As discussed on previous calls, as a platform company, we are building a unique operating model.

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。

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.

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。

We continue to see these efficiency gains in our 2024 results.

我們在 2024 年的業績中繼續看到這些效率提升。

As mentioned on the previous slide, we reduced 3Q SG&A expenses by 36% year over year.

正如上一張投影片所述，我們第三季的 SG&A 費用年減了 36%。

We had year-over-year reductions across all areas of our SG&A categories, commercial, medical and G&A functional spending.

我們的 SG&A 類別、商業、醫療和 G&A 職能支出的所有領域都比去年同期減少。

Major drivers were from reductions in purchased services and external consultants as we better leverage digital technology and AI.

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，購買的服務和外部顧問的減少。

Year-to-date, our SG&A spending is down 24% year over year.

年初至今，我們的 SG&A 支出年減 24%。

While we continue to drive productivity improvements, we are also committed to increasing COVID-19 vaccination rates with investments in HCP education and consumer ad campaigns, as well as increasing our COVID-19 and RSV market share in competitive markets.

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 教育和消費者廣告活動的投資來提高 COVID-19 疫苗接種率，並增加我們在競爭市場中的 COVID-19 和 RSV 市場份額。

Therefore, we don't expect as large a year-over-year decline in 4Q SG&A spending versus the prior year.

因此，我們預期第四季的銷售、管理及行政費用支出與上年相比不會出現如此大的年減。

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.

對於全年，我們預計 SG&A 將下降約 20%，至 12 億美元，這反映在下一張投影片的財務框架更新中。

Turning to that 2024 financial framework on slide 17.

轉向幻燈片 17 上的 2024 年財務框架。

Our net product sales guidance remains at $3 billion to $3.5 billion.

我們的淨產品銷售指引維持在 30 億至 35 億美元。

As reviewed earlier, there are a handful of factors we are monitoring as the season progresses.

如前所述，隨著賽季的進展，我們正在監控一些因素。

For cost of sales, we are narrowing our guidance to 40% to 45% of product sales as a result of the continued manufacturing productivity improvements we are driving in the company.

對於銷售成本，由於我們不斷推動公司製造生產力的提高，我們將銷售成本的指導範圍縮小到產品銷售額的 40% 至 45%。

For R&D, we are lowering our full-year estimate of $4.6 billion to $4.7 million from our previous guidance of $4.8 billion.

對於研發，我們將全年預期 46 億美元從先前的 48 億美元下調至 470 萬美元。

The reduction is due to cost savings from productivity improvements, as well as clinical study timing.

這一減少是由於生產力提高以及臨床研究時間安排所帶來的成本節省。

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.

對於 SG&A，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%。

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.

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。

The purchase of this highly strategic asset allows us full control to expand and build out the campus to drive future productivity and innovation.

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。

We anticipate this transaction will close in December.

我們預計交易將於 12 月完成。

We continue to expect ending 2024 with approximately $9 billion of cash and investments.

我們仍然預計到 2024 年底將擁有約 90 億美元的現金和投資。

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.

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。

Based on our 3Q actual product sales of $1.8 billion, we have strong visibility into our expected cash collection timing from our customers in 4Q.

根據我們第三季 18 億美元的實際產品銷售額，我們對第四季客戶的預期現金收款時間有很強的了解。

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, and good morning or good afternoon, everyone.

謝謝你，傑米，大家早安或下午好。

Today, I'll do a quick review of our pipeline.

今天，我將快速回顧我們的管道。

At our R&D event in September, we discussed our focus on 10 product approvals over the next three years.

在 9 月的研發活動中，我們討論了未來三年對 10 個產品批准的關注重點。

Today, I will briefly summarize the status of those programs.

今天我就簡單總結一下這些專案的現況。

Starting with our respiratory vaccines portfolio.

從我們的呼吸道疫苗產品組合開始。

For our next-generation COVID vaccine mRNA-1283, we are pleased with the positive Phase III safety, immunogenicity and vaccine efficacy data we presented at R&D Day, including a 13.5% higher vaccine efficacy compared to Spikevax and participants aged 65 and older in that study.

對於我們的下一代新冠疫苗mRNA-1283，我們對在研發日上展示的積極的III 期安全性、免疫原性和疫苗功效數據感到滿意，其中包括與Spikevax 和65 歲及以上參與者相比，疫苗功效高出13.5%學習。

As previously shared, we intend to file mRNA-1283 for approval in 2024, and we'll use a priority review voucher.

如同先前分享的，我們打算在 2024 年提交 mRNA-1283 的批准，我們將使用優先審查憑證。

For our RSV vaccine, mRNA-1345, we also shared positive safety and immunogenicity data from our Phase III trial in participants 18 to 59 years old who are at high risk from RSV.

對於我們的 RSV 疫苗 mRNA-1345，我們也分享了針對 18 至 59 歲 RSV 高風險參與者進行的 III 期試驗的積極安全性和免疫原性數據。

We are also using a priority review voucher for this program, which we intend to submit this year.

我們也對該計劃使用優先審查憑證，我們打算今年提交。

We also shared positive Phase III data from our combination flu/COVID vaccine, mRNA-1083 and intend to file for approval in 2024, subject to ongoing discussions with FDA.

我們也分享了流感/新冠肺炎合併疫苗 mRNA-1083 的積極 III 期數據，並打算在 2024 年提交批准申請，具體取決於與 FDA 的持續討論。

We've decided not to use a priority review voucher for this program given the timing of submission and the potential launch relative to the respiratory virus season in 2025.

考慮到提交時間以及與 2025 年呼吸道病毒季節相關的潛在啟動時間，我們決定不對該計劃使用優先審查憑證。

We will announce PDUFA dates for these programs if and when they are confirmed by the FDA.

如果這些計劃得到 FDA 確認，我們將宣布 PDUFA 日期。

Moving now to our stand-alone flu program, mRNA-1010.

現在轉向我們的獨立流感計畫 mRNA-1010。

We have initiated and substantially enrolled the first season of our Phase III vaccine efficacy study.

我們已經啟動並大量招募了第三期疫苗功效研究的第一季。

As a reminder, this Phase III study is funded within our project financing agreement with Blackstone Life Sciences.

提醒一下，這項 III 期研究由我們與 Blackstone Life Sciences 的專案融資協議資助。

Slide 20 shows the study design for that Phase III stand-alone flu vaccine.

投影片 20 顯示了 III 期獨立流感疫苗的研究設計。

This is a randomized, observer-blind active controlled study for mRNA-1010 against the standard dose competitor.

這是一項針對 mRNA-1010 與標準劑量競爭對手的隨機、觀察者盲法主動對照研究。

It is designed to be enrolled over two seasons, but the study has the possibility to declare early success after a single season.

該研究計劃在兩個賽季內進行，但該研究有可能在一個賽季後宣布早期成功。

Now turning to our non-respiratory portfolio. starting with our latent and other virus vaccines.

現在轉向我們的非呼吸產品組合。從我們的潛伏疫苗和其他病毒疫苗開始。

For our CMV vaccine, we continue to expect that we will accrue the 81 cases required for the interim analysis in our Phase III study by the end of this year.

對於我們的 CMV 疫苗，我們繼續預計到今年年底我們將累積 III 期研究中中期分析所需的 81 例病例。

Following the accrual of these cases, the Data Safety and Monitoring Board will conduct a statistical analysis, should they recommend unblinding at the interim analysis, we will share those results.

在收集這些案例後，資料安全和監測委員會將進行統計分析，如果他們建議在中期分析時揭盲，我們將分享這些結果。

For Norovirus, I'm happy to announce that we are rapidly enrolling our Phase III trial.

對於諾羅病毒，我很高興地宣布我們正在迅速進行 III 期試驗。

In a moment, I will take you through the design of that Norovirus Phase III study.

稍後，我將帶您了解諾羅病毒 III 期研究的設計。

In oncology, we and our partner, Merck have initiated a Phase III trial evaluating adjuvant INT or mRNA-4157 in combination with KEYTRUDA after neoadjuvant KEYTRUDA and chemotherapy in patients with certain types of resected non-small cell lung cancer.

在腫瘤學方面，我們和我們的合作夥伴默克公司啟動了一項III 期試驗，評估在新輔助KEYTRUDA 和化療後對某些類型的已切除非小細胞肺癌患者使用輔助INT 或mRNA-4157 聯合KEYTRUDA。

This is the second Phase III trial for INT in non-small cell lung cancer and is targeting patients who may not respond to neoadjuvant therapy alone.

這是 INT 在非小細胞肺癌中的第二項 III 期試驗，針對的是那些可能對單獨新輔助治療沒有反應的患者。

I will also review this study designed in the upcoming slides.

我還將回顧在接下來的幻燈片中設計的這項研究。

For our rare disease therapeutics, we intend to begin to generate pivotal trial data for our PA program in 2024 and for MMA, we have an agreement with FDA on our pivotal trial design.

對於我們的罕見疾病治療藥物，我們計劃在 2024 年開始為 PA 計畫產生關鍵試驗數據，對於 MMA，我們與 FDA 就我們的關鍵試驗設計達成協議。

We now expect to start that study in the first half of 2025.

我們現在預計在 2025 年上半年開始這項研究。

On slide 22 is the design of our Phase III study for our Norovirus vaccine candidate.

第 22 張投影片是我們針對諾羅病毒候選疫苗的 III 期研究設計。

As a reminder, Norovirus is a gastrointestinal disease with high unmet need and no approved vaccines on the market.

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。

The Phase III study is designed to test the efficacy, safety and immunogenicity of our vaccine in 25,000 adults, age 18 and older.

III 期研究旨在測試我們疫苗在 25,000 名 18 歲及以上成年人中的有效性、安全性和免疫原性。

It is randomized 1:1 observer-blind and placebo control.

它是隨機 1:1 觀察者盲法和安慰劑對照。

Turning now to the trial design for our second Phase III study in non-small cell lung cancer for INT in collaboration with Merck, which complements the Phase III INTerpath-002 trial.

現在談談我們與默克合作進行的第二項 INT 非小細胞肺癌 III 期研究的試驗設計，該研究是對 III 期 INTerpath-002 試驗的補充。

This Phase III study called INTerpath-009 will enroll more than 1,200 patients with Stage II to IIIb non-small cell lung cancer without an EGFR mutation and who are able to undergo surgery.

這項名為 INTerpath-009 的 III 期研究將招募 1,200 多名患有 II 期至 IIIb 期非小細胞肺癌、無 EGFR 突變且能夠接受手術的患者。

These patients will receive neoadjuvant therapy of KEYTRUDA plus chemotherapy followed by surgery.

這些患者將接受 KEYTRUDA 新輔助治療加化療，然後進行手術。

Following surgery, the study will randomize approximately 680 patients, who have not achieved a pathologic complete response into two arms, combination of INT plus KEYTRUDA or KEYTRUDA plus placebo.

手術後，研究將約 680 名尚未達到病理完全緩解的患者隨機分為兩組，即 INT 加 KEYTRUDA 或 KEYTRUDA 加安慰劑。

The primary endpoint for the study is disease-free survival, and the secondary endpoints include distant metastasis-free survival and overall survival.

研究的主要終點是無疾病存活期，次要終點包括無遠端轉移存活期和總存活期。

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

現在，我將把電話轉回給 Stéphane。

Thank you, Stephen and Jamey.

謝謝你們，史蒂芬和傑米。

During R&D Day in September, we shared the company priorities.

在九月份的研發日期間，我們分享了公司的優先事項。

Priority one, to drive sales of approved products, Spikevax and mRESVIA.

第一要務是推動已批准產品 Spikevax 和 mRESVIA 的銷售。

Priority two, focus on our late-stage pipeline where we believe we can have up to 10 product approvals over this next three years and which will be drivers of sales growth.

第二個重點是我們的後期研發管線，我們相信在未來三年內我們可以獲得多達 10 個產品批准，這將成為銷售成長的驅動力。

Priority three, to deliver cost efficiency across the business and slower pace of R&D investments, reducing annual R&D expenses by $1.1 billion, starting in 2027.

第三要務是提高整個業務的成本效率並放慢研發投資的步伐，從 2027 年開始將年度研發費用減少 11 億美元。

Our first priority is to drive sales of Spikevax and mRESVIA, which we believe are the foundation of our respiratory vaccine portfolio.

我們的首要任務是推動 Spikevax 和 mRESVIA 的銷售，我們相信這是我們呼吸道疫苗產品組合的基礎。

We will continue to work with all market channels to maximize Spikevax availability.

我們將繼續與所有市場通路合作，以最大限度地提高 Spikevax 的可用性。

We are focusing on marketing and medical education to try to drive the COVID vaccination rate closer to that of flu over time.

我們正專注於行銷和醫學教育，試圖隨著時間的推移使新冠疫苗接種率接近流感疫苗接種率。

Internationally, we plan to bring manufacturing plants online in the UK, in Canada and in Australia in 2025 and then start to fulfill multiyear contracts in those countries.

在國際上，我們計劃於 2025 年在英國、加拿大和澳洲建立製造工廠，然後開始在這些國家履行多年合約。

And with the full season of RSV contracting in the US and other countries in 2025, we expect to increase mRESVIA set the market share.

隨著 2025 年美國和其他國家 RSV 合約的滿季，我們預計 mRESVIA 的市佔率將會增加。

We are focused on delivering up to 10 product approvals over the next three years, which we believe will drive sales growth, and fund the next wave of R&D investment.

我們的重點是在未來三年內獲得最多 10 個產品批准，我們相信這將推動銷售成長，並為下一波研發投資提供資金。

For eight of these programs, we have near-some milestones.

對於其中八個項目，我們已經接近一些里程碑。

For CMV, we expect to trigger the interim analysis for Phase III vaccine efficacy study by the end of this year.

對於CMV，我們預計在今年底前啟動III期疫苗功效研究的中期分析。

We're looking forward to those results.

我們期待這些結果。

For [PMFMA], we plan to initiate pivotal studies.

對於 [PMFMA]，我們計劃啟動關鍵研究。

Our Norovirus and flu Phase III vaccine efficacy studies are now underway.

我們的諾羅病毒和流感第三期疫苗功效研究正在進行中。

Finally, we intend to file three products in 2024 for next-gen COVID vaccine, our IV vaccine for high risk 18- to 59-year old, and our combination COVID/flu vaccine which is subject to ongoing discussions with the US FDA.

最後，我們計劃在 2024 年提交三種下一代新冠疫苗產品的申請，即針對 18 至 59 歲高風險族群的靜脈注射疫苗，以及我們正在與美國 FDA 持續討論的新冠肺炎/流感組合疫苗。

We will continue to focus on improving efficiency by keeping our R&D and SG&A expenses flat to down in 2025.

到 2025 年，我們將繼續專注於提高效率，保持研發和銷售、一般管理費用持平或下降。

And as demonstrated in the quarter, we are making progress on our cost-saving initiatives already.

正如本季所表明的那樣，我們在成本節約計劃方面已經取得了進展。

By 2027, we expect to decrease annual R&D expenses by $1.1 billion.

到 2027 年，我們預計年度研發費用將減少 11 億美元。

On the cost of sales, we continue to drive efficiency, and we expect to achieve operating leverage that we outlined in the framework we shared previously.

在銷售成本方面，我們繼續提高效率，並期望實現我們在先前分享的框架中概述的營運槓桿。

We have two products approved that help protect people every day.

我們有兩種產品獲得批准，可以幫助保護人們的日常生活。

We have the largest late-stage pipeline for and mRNA company, and we'll continue to focus on deliver the greatest possible impact to people through mRNA medicine.

我們擁有最大的 mRNA 公司後期研發管線，我們將繼續專注於透過 mRNA 醫學為人們帶來最大的影響。

Where there is work to be done to meet our execution targets, I'm confident that our team will be able to achieve our goals.

如果需要做一些工作來實現我們的執行目標，我相信我們的團隊將能夠實現我們的目標。

I continue to be excited about the potential we have to deliver for patients.

我仍然對我們為患者提供的潛力感到興奮。

The actions we are taking to help people is becoming reality.

我們為幫助人們而採取的行動正在成為現實。

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

有了這個，操作員，我們將很樂意回答問題。

(Operator Instructions) Salveen Richter, Goldman Sachs.

（操作員指令）Salveen Richter，高盛。

Two questions for me.

有兩個問題問我。

One is, can you speak to the source of the rest of world revenue generated in the third quarter and expected in fourth quarter with regard to which countries are contributing here and these contracts that should you expect them to recur in 2025?

一是，您能談談世界其他地區第三季產生的收入和第四季度預計收入的來源嗎？

And then separately on CMV, you talked about the DSMB, you'll share the results of the DSMB recommends unblinding.

然後在 CMV 上，您單獨談到了 DSMB，您將分享 DSMB 建議揭盲的結果。

Can you speak more to that as to whether we will actually get interim data provided to us or we're going to have to wait for the full analysis here?

您能否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此處的全面分析？

Sure.

當然。

Thanks for the question, Salveen.

謝謝你的提問，薩爾文。

I'll take the first one in terms of rest of world revenue.

我將根據世界其他地區的收入來選擇第一個。

So without getting into too much specifics, I think you know we're establishing a presence in the United Kingdom, in Canada, in Australia, we announced an order in Brazil -- and so that's been -- the balance will be shipped either in the third quarter and the fourth quarter.

因此，無需透露太多細節，我想您知道我們正在英國、加拿大、澳大利亞建立業務，我們宣布了在巴西的訂單 - 所以這就是 - 餘額將在第三季度和第四季度。

And when we look at the fourth quarter of the $600 million on the low end, the large majority of that is contracted with those countries and others, but I just wanted to name a few.

當我們看看第四季度的 6 億美元低端資金時，其中大部分是與這些國家和其他國家簽訂的合同，但我只想舉幾個例子。

As we look to 2025, I think we mentioned at R&D Day, that there will be a decline in some of those countries.

當我們展望 2025 年時，我想我們在研發日提到，其中一些國家的銷售將會下降。

And then it will then uptick our anticipation is that it will uptick in 2026 based upon the contracts that we have in certain countries.

然後它會上升，我們的預期是，根據我們在某些​​國家/地區的合同，它會在 2026 年上升。

So that's a little bit on the rest of world split.

這就是世界其他地區的一些分歧。

And on the CMV question.

關於 CMV 問題。

So if the DSMB recommends unblinding to the sponsor at the first term analysis to your question, that would be because we met the criteria for vaccine efficacy.

因此，如果 DSMB 建議在對您的問題進行第一期分析時向申辦者揭盲，那是因為我們符合疫苗功效的標準。

And obviously, we would share those results if we receive them.

顯然，如果我們收到這些結果，我們會分享這些結果。

There is a chance that the DSMB will not recommend unblinding, which would mean perhaps that we did not make statistical significance in that first interim analysis and be going then to the final analysis, which could happen quite quickly.

DSMB 有可能不建議揭盲，這可能意味著我們在第一次中期分析中沒有產生統計顯著性，然後進行最終分析，這可能很快就會發生。

And depending upon the conditions of that communication and the timing of that final analysis, we may or may not be communicating right then about the fact that we're waiting for that final analysis.

根據溝通的條件和最終分析的時間，我們可能會也可能不會立即溝通我們正在等待最終分析的事實。

But we would, in any event, if the DSMB recommended unblinding, share those results.

但無論如何，如果 DSMB 建議揭盲，我們都會分享這些結果。

Ellie Merle, UBS.

艾莉·梅爾，瑞銀。

Just another one on how to think about the ex-US COVID revenues.

這又是另一篇關於如何思考美國以外的新冠疫情收入的文章。

In the past, you've talked about some contracts with some countries for guaranteed purchases like some even throughout the end of the decade.

過去，您談到與某些國家/地區簽訂的一些保證購買的合同，例如一些甚至在本世紀末的合同。

Maybe can you just in broad strokes characterize the size of some of these contracts that you have outstanding ex US?

也許您可以粗略地描述一下您在美國以外地區未完成的一些合約的規模？

And I guess what's essentially guaranteed from a revenue perspective here in terms of some of these ex US contracts sort of if you have a sense of maybe like what the minimum sales ex-US could be in certain years going forward based on that?

我想，從收入的角度來看，如果您有這樣的感覺，即未來某些年份美國以外的最低銷售額可能會是多少，那麼就這些美國以外的合約而言，本質上有什麼保證？

And then just a second follow-up on CMV.

然後是 CMV 的第二次追蹤。

I think you alluded to this in the last answer, but maybe just in terms of the rate of accruals, I guess what's your latest expectation in terms of the time frame between when you will accrue the number of events to trigger the interim versus the number of events to trigger the final analysis, just the timing between those two.

我認為您在上一個答案中提到了這一點，但也許只是就應計率而言，我猜您對累積觸發臨時事件的數量與觸發臨時事件的數量之間的時間範圍的最新期望是什麼觸發最終分析的事件，只是這兩者之間的時間。

Okay.

好的。

Yes, sure.

是的，當然。

So I'll take the first part, Ellie.

所以我要講第一部分，艾莉。

So in terms of the contract that we have with some of these countries, we're not going to disclose the specifics.

因此，就我們與其中一些國家簽訂的合約而言，我們不會透露具體細節。

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.

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。

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.

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.

但我認為我們不會透露更多的內容。

On the question on CMV and the timing of case accrual, it is coming quite steadily right now.

關於 CMV 和案件應計時間的問題，目前進展相當穩定。

And in fact, we do have a bit of a backlog of case confirmation that we are working through.

事實上，我們確實有一些積壓的案件確認工作正在處理。

There's multiple steps that have to go with multiple testing to validate a case.

需要執行多個步驟並進行多次測試才能驗證案例。

And so we actually -- obviously, we don't control the rate of case accrual, but we do expect that if we are going to that final analysis, that it won't be a very long period of time between and actually could happen quite quickly.

因此，我們實際上 - 顯然，我們無法控制案件應計率，但我們確實預計，如果我們進行最終分析，那麼這之間的時間不會很長，並且實際上可能會發生很快。

Gena Wang, Barclays.

王吉娜，巴克萊銀行。

I have two questions.

我有兩個問題。

One is regarding the commercial questions.

一是關於商業問題。

If we calculate USD1.2 billion revenue and accumulate 19 million US doses, is the calculation like $63 per dose as a net price is the right way to think about it?

如果我們計算 12 億美元的收入並累積 1,900 萬劑美國疫苗，那麼每劑淨價 63 美元的計算方式是否正確？

And then regarding the reserve return, could you provide a final reserve return from last winter season?

那麼關於儲備回報，你能提供去年冬季的最終儲備回報嗎？

And what is your reserve return so far for this winter season?

到目前為止，您今年冬季的儲備回報是多少？

And quickly regarding the flu/COVID combo, not using priority voucher, maybe give us a little bit more rationale for this?

快速考慮流感/新冠肺炎組合，不使用優先券，也許可以給我們更多的理由？

And then will all three that you submit this year?

那麼您今年提交的三項都會嗎？

How many of these will make it for 2025 winter season?

其中有多少可以在 2025 年冬季使用？

Yes, Gena, maybe I'll take the first question.

是的，Gena，也許我會回答第一個問題。

So on the US pricing, the $19 million, I think, is the total market you might be referring to for COVID vaccinations, not specific to Moderna.

因此，就美國的定價而言，我認為 1900 萬美元是您可能指的新冠疫苗市場的總市場，而不是 Moderna 特有的市場。

That said, the pricing that you're talking about, we won't specifically disclose, but it's not that far off.

也就是說，你所說的定價，我們不會具體透露，但也相差不遠。

On the pipeline questions, Gena, thank you for both.

關於管道問題，Gena，謝謝你們兩位。

So first on the priority review voucher for the flu/COVID combo.

首先是流感/新冠肺炎組合的優先審查憑證。

Given where we are in terms of timing of this year and relative timing of the contracting season for flu vaccines, we no longer think it makes sense to use a priority review voucher to try and accelerate that process because ultimately, we believe we would miss the contracting season.

考慮到我們今年的時間表以及流感疫苗簽約季節的相對時間安排，我們不再認為使用優先審查憑證來嘗試加速這一進程是有意義的，因為最終我們相信我們會錯過簽約季節。

For that reason, we'll hold back that PRV and use it for a different product in the future.

因此，我們將保留該 PRV 並在將來將其用於不同的產品。

As far as the submissions, as we confirm today, we are expecting the other two submissions to go forward with priority review vouchers.

就提交內容而言，正如我們今天確認的那樣，我們預計其他兩份提交內容將獲得優先審查憑證。

And given the time lines, you can understand that we think that means approval next year is possible and can happen prior to the season.

考慮到時間線，你可以理解，我們認為這意味著明年的批准是可能的，並且可能會在賽季之前發生。

However, we do not include any revenue from either the 18 to 59 RSV sBLA or 1,283 in our 2025 guidance or expectations.

然而，我們的 2025 年指引或預期中並未包括 18 至 59 RSV sBLA 或 1,283 的任何收入。

And so if we were able to deliver those with those priority reviews and approvals, we still wouldn't include any revenue that would be an upside.

因此，如果我們能夠提供那些經過優先審查和批准的產品，我們仍然不會包含任何有利的收入。

Reserve return?

預留退貨？

Sorry, could you repeat the question, Gena?

抱歉，你能重複這個問題嗎，Gena？

I missed the sales return part.

我錯過了銷售退貨部分。

Yes, sure.

是的，當然。

Could you provide the final reserve return from last winter season?

您能提供去年冬季的最終儲備回報嗎？

Because I know you initially booked over $500 million and you need to adjust it to see the final numbers.

因為我知道您最初預訂的金額超過 5 億美元，您需要對其進行調整才能看到最終的數字。

So if you could provide that final numbers?

那麼您能否提供最終數字？

And what is your reserve return assumption so far for this winter season?

到目前為止，您對今年冬季的儲備回報假設是多少？

Yes.

是的。

So as I mentioned in my prepared remarks that we released in the quarter about $140 million, primarily driven from returns reserves being lower than our prior estimate.

正如我在準備好的發言中提到的，我們在本季度釋放了約 1.4 億美元，主要是由於回報準備金低於我們先前的估計。

So that $500 million-plus went down to, let's say, $400 million for the prior season.

這樣一來，上一季的 5 億多美元就減少了 4 億美元。

So we learned from that and continue to forecast what an anticipated product 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 project into the first quarter of next year.

因此，我們從中吸取了教訓，並繼續預測本季的預期產品退貨儲備是多少，我們將在觀察整個季度的疫苗接種率時繼續對其進行監控。以及我們對明年第一季的預測。

Michael Yee, Jefferies.

麥可葉，杰弗里斯。

Two questions, not 10.

兩個問題，不是 10 個。

But on the combo, I know that you say you're in discussions with the FDA.

但關於組合，我知道你說你正在與 FDA 進行討論。

Can you just clarify what are the different factors that are contributing to why you have maybe lack of confidence on filing or I guess not certainty on filing the combo, for example, would there be an infection study that has to be run?

您能否澄清一下，有哪些不同因素導致您對提交缺乏信心，或者我猜對提交組合不確定，例如，是否需要進行感染研究？

I think it's a little unclear to us on the combo.

我認為我們對組合有點不清楚。

And then on RSV, I think the market had anticipated this was going to be a big market.

然後就 RSV 而言，我認為市場已經預料到這將是一個大市場。

However, obviously, there is a lot of dynamics going on there.

然而，顯然，那裡正在發生很多動態。

Can you maybe comment on whether you think there will be a change to this market?

您能否評論一下您認為這個市場是否會改變？

And what would give you confidence that you're going to actually be a player here?

什麼會讓你有信心成為這裡的球員？

Given your current position now and where your guidance is for 2025.

鑑於您目前的立場以及您對 2025 年的指導。

Thank you for both questions.

謝謝你的兩個問題。

I'll take the combo and I think Stéphane will take the question on RSV.

我將接受組合，我認為 Stéphane 將回答有關 RSV 的問題。

So first, we are in discussions with the FDA.

首先，我們正在與 FDA 進行討論。

The data for 1083, as you'll remember, came sort of middle of this year.

您還記得，1083 的數據是在今年年中得出的。

And so we've only more recently had the opportunities to be sharing that and engage in discussions about what would be in the BLA for accelerated approval of 1083 based on immunogenicity results.

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，以根據免疫原性結果加速批准 1083。

I would not comment on those discussions back and forth.

我不會對這些來回的討論發表評論。

We continue to work closely with the agency to understand what they would like to see in that.

我們將繼續與該機構密切合作，以了解他們希望看到什麼。

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.

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。

The decision not to use the priority review voucher became one about the timing of that approval and ultimately, our view that would -- we would miss the contracting season for influenza, and therefore, it didn't make sense to do that.

不使用優先審查憑證的決定成為了批准時間的決定，最終，我們的觀點是——我們將錯過流感的發病季節，因此，這樣做是沒有意義的。

But by withdrawing the priority review voucher, we also allow for a more fulsome time for review, which is also obviously the benefit of ourselves and the agency.

但透過撤回優先審查憑證，我們也為審查提供了更充裕的時間，這顯然也是對我們自己和機構的好處。

And on the RSV, Mike, I think there's a few things.

關於 RSV，麥克，我認為有一些事情。

As you know, the market has been much lower than last year, and much lower than people anticipated.

大家知道，市場比去年低很多，也比人們預期低很多。

Obviously, the new CDC guidelines that came out in the June time frame impacted that.

顯然，六月發布的新的 CDC 指南對此產生了影響。

The other piece we are hearing from customers is that they're really focused on making sure people get COVID through vaccination right now.

我們從客戶那裡聽到的另一件事是，他們現在真正關注的是確保人們透過疫苗接種感染新冠病毒。

So I think it's going to 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 previous season.

因此，我認為看看第一季會發生什麼可能會非常有趣，因此 IV 曲線的形狀看起來與我們在上一季看到的不同。

So that's to be seen.

所以這還有待觀察。

The other piece is because through contracting and because of what happened last year and there's no contracting happened before the CDC guideline.

另一部分是因為透過合同，並且因為去年發生的事情，並且在疾病預防控制中心指導方針之前沒有發生合約。

There's quite a lot of volume in the channel, whether both at the retailers themselves and in the wholesalers.

無論是零售商本身還是批發商，該通路的銷售量都相當大。

And so of course, with a much lower market and a large inventory in the customers and both wholesaler and retail pharmacies as you can imagine is taking quite some time to go through that inventory.

當然，由於市場低得多，而且客戶、批發商和零售藥局的庫存量很大，你可以想像，需要相當長的時間來清理這些庫存。

And so we think that there's an interesting question about the market dynamic in terms of timing, again, will Q1 be a more important timing for RSV going forward.

因此，我們認為，就時機而言，市場動態存在一個有趣的問題，即第一季是否會成為 RSV 未來更重要的時機。

It's a question to be seen.

這是一個有待觀察的問題。

Of course, we expect as more data accumulate, CDC will continue to review and look at what is the right guideline.

當然，我們預計隨著更多數據的積累，疾病預防控制中心將繼續審查並研究什麼是正確的指導方針。

So that's for the public leaders to decide and being able to totally contract COVID and RSV at the same time for a full season, we believe it's going to have an impact in the US.

因此，這是由公共領導人決定的，並且能夠在整個季節同時完全感染新冠病毒和呼吸道合胞病毒，我們相信這將對美國產生影響。

And the other piece I mentioned also in my remarks, is outside the US, which is as you know, we have no sales outside the US.

我在演講中也提到的另一件事是在美國之外，正如你所知，我們在美國以外沒有銷售。

We are getting approvals, and they're going to continue to happen in the months to come.

我們正在獲得批准，而這些批准將在未來幾個月內繼續發生。

So we believe '25 and beyond should also help outside the US.

因此，我們認為 25 年及以後也應該對美國以外的地區有所幫助。

Tyler Van Buren, TD Cowen.

泰勒·範布倫，TD·考恩。

So I wanted to ask about US COVID vaccine sales.

所以我想問美國新冠疫苗的銷售情況。

So they were roughly flat quarter over quarter between Q3 and Q4 last year.

因此，去年第三季和第四季之間的季度環比大致持平。

But the vaccine sales guidance for Q4 this year assumes a decline as much as 60% to 80% quarter over quarter if RSV sales remain low and my math is correct.

但今年第四季的疫苗銷售指導假設，如果 RSV 銷售保持在低水平並且我的數學是正確的，則季度環比下降高達 60% 至 80%。

So is there a significant shift occurring this year due to the vaccines being available earlier and patients getting vaccinated earlier that you expect to be the dynamic moving forward?

那麼，由於疫苗更早上市以及患者更早接種疫苗，今年是否會出現重大轉變，而您預計這將成為未來的動力？

Or could this guidance be conservative?

或者這個指導可能是保守的？

I just asked because it's a pretty dramatic change in the cadence of US sales.

我之所以這麼問，是因為美國銷售節奏發生了相當大的變化。

So any additional color would be appreciated.

因此任何額外的顏色將不勝感激。

Thank you.

謝謝。

So if you think about the US market, I think what is important first is to look at the different channels because they are very different, As we share the data that we have is the IQVIA data for retail and long-term care facilities.

因此，如果你考慮美國市場，我認為首先重要的是要專注於不同的管道，因為它們非常不同，因為我們共享的數據是零售和長期照護機構的 IQVIA 數據。

As you see, earlier start season to date, a little bit ahead.

正如你所看到的，到目前為止，賽季開始較早，提前了一點。

But if you look at the weekly scripts, they are coming down the peak.

但如果你看一下每週的劇本，你會發現它們正在走下坡。

We hear from retailers that they are working very hard in terms of vaccination campaign ahead of Thanksgiving and they also have plans ahead of Christmas between Thanksgiving and Christmas.

我們從零售商那裡得知，他們在感恩節前正在非常努力地進行疫苗接種活動，並且他們還在感恩節和聖誕節之間的聖誕節前製定了計劃。

But that is to be seen what happens, what is a shape of that curve.

但這有待觀察會發生什麼，曲線的形狀是什麼。

And then there is the IDN networks.

然後是 IDN 網路。

As I said in my remarks, we have been working with IDN networks to increase the COVID to flu vaccination rate versus last year.

正如我在演講中所說，我們一直在與 IDN 網路合作，以比去年提高新冠肺炎疫苗接種率。

We don't have a lot of visibility because those campaigns started later, most of them early October, we as used the retailer starting in August with some of them starting pretty strong in August and early September.

我們沒有太多的知名度，因為這些活動開始較晚，其中大多數是十月初，我們從八月份開始與零售商合作，其中一些活動在八月和九月初開始相當強勁。

And then the government data for which we have no visibility, we only get orders when the orders coming.

然後我們看不到政府數據，我們只有在訂單到來時才收到訂單。

So it's still early in the season.

所以現在還處於賽季初期。

The shape is clearly different from last year in retail.

零售業的形態與去年明顯不同。

We are hoping that we will work on retailers and our work in might tail off with different shape as last year.

我們希望我們能夠在零售商方面開展工作，我們的工作可能會以與去年不同的形式結束。

And then IDNs and government.

然後是 IDN 和政府。

So we will have to see and we're continuing to learn about this market, but we believe it still remains sizable and clearly durable.

因此，我們必須觀察並繼續了解這個市場，但我們相信它仍然具有相當大的規模並且顯然是持久的。

We see that millions of people who want the COVID vaccination.

我們看到有數百萬人想要接種新冠疫苗。

Yes.

是的。

And maybe I would just add that, remember, when we sell product, that is not tied to vaccination.

也許我想補充一點，請記住，當我們銷售產品時，這與疫苗接種無關。

So when you look at the decline from the third quarter to the fourth quarter, we had an early approval to Stéphane's point.

因此，當你看到第三季到第四季的下降時，我們很早就認可了史蒂芬的觀點。

So therefore -- and we were better ready to ship more within the third quarter.

因此，我們已經做好更好的準備，在第三季內出貨更多。

So that's what I think you see on a year-over-year basis, what's happening here.

所以我認為這就是您逐年看到的情況，這裡正在發生的事情。

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

I was just wondering on the INT program, obviously, you're continuing to accelerate the clinical program here with the new Phase III in lung.

我只是想知道 INT 項目，顯然，你們正在繼續加速新的肺 III 期臨床項目。

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?

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？

And then if there's going to be any bridging work required by the FDA for approval or validation?

那麼 FDA 是否需要進行任何過渡工作才能獲得批准或驗證？

Terence, yes.

特倫斯，是的。

So the team continues to do a great job in the plant with all the progress are totally on schedule.

因此，團隊繼續在工廠中出色地工作，所有進展都完全按計劃進行。

And so given what we shared at R&D Day in terms of timing with FDA, the plant will no longer be a critical path to approval.

因此，考慮到我們在研發日與 FDA 分享的時間安排，該工廠將不再是獲得批准的關鍵途徑。

But we're keeping the team working really hard, and they're making great progress.

但我們讓團隊非常努力地工作，他們正在取得巨大的進步。

So we're very pleased with that.

所以我們對此非常滿意。

Yes.

是的。

And on the question of bridging, once the plant is operational, we'll transition our clinical work to that plant as well.

關於橋接問題，一旦工廠投入運營，我們也將把我們的臨床工作轉移到該工廠。

And so effectively, all of the programs will include -- many of the programs may include, I should say, that data.

因此，所有的計劃都將有效地包括——我應該說，許多計劃可能包括這些數據。

So the bridging will be done in stream.

因此橋接將在流中完成。

Evan Wang, Guggenheim Securities.

艾文王，古根漢證券。

Two for me.

給我兩個。

First, on the election results.

首先，關於選舉結果。

Just wondering given the pending change in administration, what barriers are in place from policy or legislative standpoint that would meaningfully limit threats to current use of vaccine in the US?

只是想知道，鑑於政府即將發生變化，從政策或立法的角度來看，有哪些障礙可以有效限制美國目前使用疫苗的威脅？

What steps are you doing to reassure confidence there and protect against potential increase in legal liabilities?

您正在採取哪些措施來增強信心並防止法律責任可能增加？

And one on RSV, some competitors are describing how data are now sufficient for expansion in international revenues.

就 RSV 而言，一些競爭對手正在描述數據現在如何足以擴大國際收入。

Do you agree there?

你同意嗎？

And what gives you confidence in competitiveness ex-US specifically?

是什麼讓您對美國以外的競爭力充滿信心？

Good morning.

早安.

So thank you for the questions.

謝謝你的提問。

So on your first question, as you know, our mission of the company is to bring innovative medicines to help people either prevent disease or treat disease.

關於你的第一個問題，如你所知，我們公司的使命是提供創新藥物來幫助人們預防疾病或治療疾病。

Since the company founding, we've always worked very closely with governments leader and public health leaders around the world, including, of course, the US.

自公司成立以來，我們始終與世界各地的政府領導人和公共衛生領導人密切合作，當然也包括美國。

And as you know, we work very collaboratively with President Trump during his first term.

如您所知，我們在川普總統的第一個任期內與他密切合作。

And so we're going to continue to do that.

所以我們將繼續這樣做。

Our mission is to really ensure we help people and we increase people's health, which is totally align with what the administration is going to work on.

我們的使命是真正確保我們幫助人們並改善人們的健康，這與政府將要進行的工作完全一致。

On RSV, outside the US, as you know, the market have approved the product at very different times.

對於 RSV，如您所知，在美國以外，市場在不同的時間批准了該產品。

Outside the US, you have a very similar process than you have in the US because once you get approval, you need to get for recommendation, which is CDC (inaudible) which in some markets happen at different times.

在美國以外，您的流程與美國的流程非常相似，因為一旦獲得批准，您就需要獲得推薦，即 CDC（聽不清楚），這在某些市場中會在不同時間發生。

Then you have pricing negotiation, which, as you know, are quite different outside the US and the US.

然後你需要進行定價談判，正如你所知，定價談判在美國和美國以外的地區有很大不同。

Sometimes you might miss a whole season because of the timing of those different elements, As you know in the US, there's no pricing negotiation where you can lose sometimes months or quarters.

有時您可能會因為這些不同元素的時間安排而錯過整個賽季，正如您所知，在美國，沒有定價談判，您有時可能會損失幾個月或幾個季度。

So I think the slower ramp outside the US is reflecting both the recommendations that sometimes tend to be for all the population like 70 and above or in countries 75 and above.

因此，我認為美國以外的緩慢增長反映了有時往往針對所有人口（例如 70 歲及以上或 75 歲及以上的國家）的建議。

And just the timing of all the mechanics to come together and then again, you could miss a season by a few weeks and you just miss the season.

只是所有機制聚集在一起的時機，然後，你可能會錯過一個賽季幾週，然後你就錯過了這個賽季。

So those are the dynamics happening outside the US.

這些就是美國以外發生的動態。

We continue to believe that RSV causes hospitalization and hurts people and the RSV vaccines are going to be important to prevent people getting hospitalized, especially if you think in terms of the tailwinds, we have an aging population in Europe.

我們仍然相信 RSV 會導致住院並傷害人們，RSV 疫苗對於防止人們住院非常重要，特別是考慮到歐洲人口老化的有利因素。

We have a aging population in Asia.

亞洲人口老化。

And so I continue to believe that over time, the RSV market outside the US would be an important market.

因此，我仍然相信，隨著時間的推移，美國以外的 RSV 市場將成為一個重要的市場。

But there's a lot of education to do, both at the consumer level, where a lot of consumers didn't even know what RSV was until recently.

但在消費者層面，還有很多教育工作要做，很多消費者直到最近才知道 RSV 是什麼。

Some don't know as of today, same with some doctors.

截至今天，有些人還不知道，有些醫生也是如此。

So there's just a lot of work to do.

所以還有很多工作要做。

But the virus is hurting people.

但病毒正在傷害人們。

So there is a need there, and we collectively need to work with public figures to prevent hospitalization.

因此，這是有必要的，我們需要共同與公眾人物合作，以防止住院。

Everybody knows, especially in governments that are single players that vaccines are most probably the best ROI that you get in our health care dollars.

每個人都知道，尤其是在單一參與者的政府中，疫苗很可能是我們醫療保健資金中獲得的最佳投資報酬率。

And the best way to not have hospitals with too many is to get prevention.

避免醫院人太多的最好方法就是預防。

Edward Tenthoff, Piper Sandler.

愛德華·騰索夫，派珀·桑德勒。

Great.

偉大的。

I appreciate all the time and all the detail.

我很欣賞所有的時間和所有的細節。

Just looking at the orphan disease pipeline, with respect to kind of pivotal trial starts for MMA in the first half and I think also maybe generating some registrational data this year.

只要看看孤兒疾病管道，就 MMA 上半年開始的關鍵試驗而言，我認為今年也可能會產生一些註冊數據。

What do you see as sort of the path forward here in terms of trial design, patient numbers, follow-up.

您認為試驗設計、患者數量和追蹤的前進道路是什麼？

When do you think we could actually see these two data that could lead to the filing here?

您認為我們什麼時候可以真正看到這兩個可以導致此處提交的數據？

Thanks, Ted.

謝謝，泰德。

So in both cases, we'll be moving forward, as we said, either presently or very quickly in 2025 in the case of MMA into the pivotal study design.

因此，正如我們所說，在這兩種情況下，我們都將在目前或 2025 年很快推進 MMA 的關鍵研究設計。

The answer is a little bit different for both.

兩者的答案都略有不同。

In the case of MMA, as we've discussed previously, we do believe there is a biomarker that can serve as the basis for approval.

就 MMA 而言，正如我們之前討論的那樣，我們確實相信有一種生物標誌物可以作為批准的基礎。

That's the subject of our discussions with the FDA and that biomarker result, as you can imagine, can be achieved somewhat more quickly than in the case of PA, will we be looking because there is not as clear a biomarker, we'll be looking at event rates, which can take some more time.

這是我們與 FDA 討論的主題，正如您可以想像的那樣，可以比 PA 更快地獲得生物標誌物結果，我們是否會尋找，因為沒有那麼明確的生物標誌物，我們將尋找以事件發生率計算，這可能需要更多時間。

And in any event, it will depend upon the rate of enrollment in those studies and then how quickly we can get to -- ultimately, we hope is a significant benefit either with the biomarker or with the event rates for PA.

無論如何，這將取決於這些研究的入組率，以及我們能多快實現——最終，我們希望生物標記或 PA 事件發生率能帶來顯著的益處。

As we've previously described at R&D Day, we do expect that can happen within the next couple of years.

正如我們之前在研發日所描述的那樣，我們確實預計這可能會在未來幾年內發生。

And our goal is to be launching that product in that sort of third window, 2026 plus, but both of those products, I should say, in the 2026 plus time horizon.

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，這兩種產品都是在 2026 年以後的時間範圍內推出的。

If we accrue patients more quickly into those studies, it could be sooner.

如果我們更快吸引患者參與這些研究，時間可能會更快。

If it takes longer, it could be a little bit longer.

如果需要更長的時間，可能會更長一些。

We'll obviously update as we go forward in how we're doing enrollment in those studies.

隨著我們如何進行這些研究的註冊，我們顯然會進行更新。

Luca Issi, RBC Capital.

盧卡·伊西，加拿大皇家銀行資本。

Maybe on RSV, obviously, this year has been a little challenging, given the late approval versus the time of its contracting season.

也許就 RSV 而言，顯然，今年有點具有挑戰性，因為與合約季節相比，批准較晚。

But how should we think about next year?

但我們該如何思考明年呢？

Do you think it is fair for us to assume that you can get a third of the market share given pre-filled syringes and obviously, no GBS?

您認為我們假設您可以獲得預充式註射器三分之一的市場份額並且顯然沒有 GBS，這是否公平？

Or do you think that, that will be optimistic.

或者你認為，那會是樂觀的。

And then maybe second on COVID in the US.

然後可能在美國的新冠疫情方面排名第二。

How should we think about again about market share here?

我們該如何重新考慮這裡的市佔率？

It looks to me the last year, you were gaining some shares versus Pfizer versus this year, it looks like you're maybe losing some shares versus them.

在我看來，去年你相對於輝瑞公司獲得了一些股票，而今年，看起來你可能會相對於他們失去一些股票。

So wondering if you can offer any additional color on that.

所以想知道你是否可以提供任何額外的顏色。

Sure.

當然。

So on RSV, I mean, across products, we don't guide our own share.

因此，在 RSV 上，我的意思是，在所有產品中，我們不指導自己的份額。

So we're not going to start guiding our own share.

所以我們不會開始指導我們自己的份額。

As I said, we believe very much so that being able to contract in full season will be quite different from last year.

正如我所說，我們非常相信能夠在整個賽季中簽約將與去年有很大不同。

So we'll play this out in the 2025 season.

所以我們將在 2025 年賽季解決這個問題。

In some of COVID, you are correct in terms of the retail market.

在某些新冠疫情中，您對零售市場的看法是正確的。

We have lost some market share as we've indicated earlier in the year.

正如我們在今年早些時候指出的那樣，我們已經失去了一些市場份額。

This has been quite an intense competitive environment in the US.

美國的競爭環境相當激烈。

What we don't know yet is the share in retail -- sorry, in IDN and government.

我們還不知道零售業的份額——抱歉，是 IDN 和政府的份額。

So we get a good sense about the share holistically at the end of the season.

因此，我們在賽季結束時對整體份額有了很好的了解。

So that's a bit where we are at this stage.

這就是我們現階段的情況。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

The first one that I want to ask was just around the INT.

我想問的第一個問題就是關於 INT 的。

Obviously, you have just initiated this new 009 trial in non-small cell lung cancer that has the chemo combo proceeding the INT.

顯然，您剛剛啟動了針對非小細胞肺癌的新 009 試驗，其中化療組合正在進行 INT。

There's a few different reasons as to why you might be doing it -- running the trial that way.

您這樣做的原因有幾個不同的原因——以這種方式進行試驗。

It could be that you're seeing kind of the current paradigm is falling in the direction of chemo combination.

您可能會看到目前的範式正在朝著化療組合的方向發展。

There's a scientific belief that INT works well in the post-chemo space or kind of just about practical timing for INT preparation.

有一種科學信念認為，INT 在化療後的空間中效果很好，或者說是 INT 準備的實用時機。

Can you give some context to that particular trial design?

您能為該特定試驗設計提供一些背景資訊嗎？

And then as we think about expansion of this program more broadly to other tumor areas.

然後，當我們考慮將該計劃更廣泛地擴展到其他腫瘤領域時。

Kind of what's primarily gating that?

是什麼樣的主要門控？

Is that the scientific signals?

這是科學訊號嗎？

Or is that manufacturing capacity for the Phase III development plan?

還是三期開發計畫的製造能力？

Thank you for both questions.

謝謝你的兩個問題。

So first, in the non-small cell lung cancer context, there has been a move.

首先，在非小細胞肺癌方面，已經有了進展。

It's really evolving standard of care.

這確實是不斷發展的護理標準。

So there obviously has been a move from just adjuvant towards neoadjuvant use of checkpoints and KEYTRUDA specifically.

因此，顯然檢查點和 KEYTRUDA 的使用已經從單純輔助轉向新輔助。

And there are a number of patients that have a pathologic complete response, a clearance of their tumor and have evidence of that as a result of that neoadjuvant chemo plus KEYTRUDA.

許多患者獲得了病理學完全緩解，腫瘤被清除，並且有證據表明新輔助化療加上 KEYTRUDA 的結果。

And so recognizing that there's a move towards that standard of care, we also want to confirm the potential for INT to benefit those patients.

因此，我們認識到護理標準正在取得進展，因此我們也想確認 INT 使這些患者受益的潛力。

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 of their tumor.

顯然，您不會指望那些已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，他們的腫瘤確實得到了很好的清除。

And so the structure of the study is to obviously enroll patients allow them to get that treatment and approximately half, you can see about 680.

因此，這項研究的結構顯然是招募患者，讓他們接受治療，大約一半，你可以看到大約 680 名患者。

We would expect to not have had that pathologic complete response.

我們預計不會出現病理性完全緩解。

And that's the group that we then randomized and go see whether INT can add on top of adjuvant at that point, KEYTRUDA treatment with further KEYTRUDA.

然後我們對這組進行隨機分組，看看 INT 是否可以在佐劑的基礎上添加 KEYTRUDA 治療並進一步使用 KEYTRUDA。

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 neoadjuvant use of KEYTRUDA.

我真的認為驅動因素是我們認為肺癌領域的潛在護理標準正在朝著 KEYTRUDA 新輔助治療的方向發展。

There may be other applications, 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 adjuvant setting.

從更廣泛的角度考慮，可能還有其他應用，新輔助治療開始出現，我們選擇研究 INT 在新輔助環境中的益處，而不僅僅是在輔助環境中。

As far as other indications, the short version is we continue with our partner, Merck, to systematically look at all the places that we think that INT can offer a benefit.

至於其他跡象，簡短的版本是我們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 INT 可以提供好處的所有地方。

We aren't done yet.

我們還沒完成。

There are more studies coming.

還有更多的研究即將到來。

We are pacing ourselves as we stand up those investments.

我們在進行這些投資時正在調整自己的步調。

But manufacturing capacity is only one of the considerations.

但製造能力只是考慮因素之一。

It's not the primary consideration.

這不是首要考慮的。

To some extent, this is about also just pacing the start of these studies.

某種程度上，這也只是這些研究的開端。

As you can see, we're starting to deploy a large Phase II and Phase III program, and we just want to be disciplined about not adding too many at the same time.

正如您所看到的，我們正在開始部署大型第二階段和第三階段計劃，我們只是想遵守紀律，不要同時添加太多項目。

So we will continue, we do continue to discuss with our partner Merck additional Phase III programs.

因此，我們將繼續與我們的合作夥伴默克繼續討論其他第三階段計劃。

We will start new ones in the coming year that we haven't yet announced.

我們將在來年啟動尚未宣布的新項目。

But we will pace ourselves both for manufacturing and just simply the ability to execute and the overall scale of that program.

但我們將在製造、執行能力和該計劃的整體規模方面調整自己的步伐。

Manos Mastorakis, Deutsche Bank.

馬諾斯‧馬斯托拉基斯，德意志銀行。

Quick question.

快問。

Manos Mastorakis from Deutsche Bank on behalf of Emmanuel.

德意志銀行的馬諾斯·馬斯托拉基斯 (Manos Mastorakis) 代表伊曼紐爾 (Emmanuel)。

So if approved, how quickly do you expect the flu market to transition to combination COVID?

那麼，如果獲得批准，您預計流感市場將多快過渡到混合型新冠肺炎？

And would that be expected to happen in 2025 already or more of a mid-term thing?

預計這種情況會在 2025 年發生還是更多地發生在中期？

And secondly, what's the latest update and perspectives you have on the COVID litigation and in particular, GSK's recent lawsuit?

其次，您對新冠病毒訴訟，特別是葛蘭素史克最近的訴訟有何最新進展和看法？

I'll take the first question on timing.

我將回答關於時間的第一個問題。

So on flu COVID, obviously, it depends upon approval, and it's also dependent upon public health sort of recommendation.

因此，對於流感新冠病毒，顯然，這取決於批准，也取決於公共衛生方面的建議。

From a purely launch timing perspective and contracting perspective, we do not believe that 2025 is the time when that will happen.

從純粹的發佈時間角度和合約角度來看，我們認為 2025 年不會發生這種情況。

That's because a majority in the United States, the majority of the flu contracting is happening really early in the year in the first quarter or the first half.

這是因為在美國，大多數流感感染都發生在年初的第一季或上半年。

And for that reason, given the timing of our current submission and approval, we wouldn't expect that to be a 2025 event.

因此，考慮到我們目前提交和批准的時間，我們預計這不會是 2025 年的事件。

We would hope that it would happen in 2026 and ultimately, we are working towards that because we see a huge potential public health benefit in terms of prevention of upwards of hundreds of thousands of hospitalizations in the United States, if we can improve compliance with COVID vaccines as well as deliver highly effective flu vaccine.

我們希望這能在 2026 年實現，最終我們正在為此努力，因為如果我們能夠提高對新冠病毒的依從性，我們看到在預防美國數十萬例住院方面具有巨大的潛在公共衛生效益疫苗以及提供高效的流感疫苗。

But again, the timing of that will be contingent upon the regulatory review process and then ultimate recommendation processes in different markets.

但同樣，這一時間將取決於監管審查流程以及不同市場的最終推薦流程。

Over the long term, we are believers that a combination flu/COVID product is the right way for us to be protecting those at high risk of respiratory viruses seasonally in all the markets in which we play in.

從長遠來看，我們相信流感/新冠肺炎組合產品是我們在我們所在的所有市場中季節性保護呼吸道病毒高風險族群的正確方法。

And so from a very long-term view, we are quite bullish on the opportunity of the combo product.

因此，從長遠來看，我們非常看好組合產品的機會。

We will not comment on the merits of the GSK case.

我們不會評論葛蘭素史克案的實質。

We would note that such lawsuits are not uncommon during market formation around new technology and we are prepared to defend ourselves from these claims.

我們要指出的是，在圍繞新技術的市場形成過程中，此類訴訟並不罕見，我們準備為自己辯護，免受這些索賠的侵害。

We look forward to presenting our case at trial once scheduled.

我們期待在預定的審判中陳述我們的案件。

Ladies and gentlemen, this does conclude the Q&A portion of today's conference.

女士們、先生們，今天會議的問答部分到此結束。

I'd like to turn the call back over to Stéphane for any closing remarks.

我想將電話轉回給 Stéphane，讓其結束語。

Well, thank you, everybody for joining us today.

好的，謝謝大家今天加入我們。

We look forward to talking to many of you in the next days and weeks.

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。

Have a great day.

祝你有美好的一天。

Ladies and gentlemen, this does conclude today's presentation.

女士們、先生們，今天的演講到此結束。

You may now disconnect, and have a wonderful day.

您現在可以斷開連接，並度過美好的一天。