莫德納 (MRNA) 2024 Q2 法說會逐字稿

Good day and thank you for standing by. Welcome to the Moderna second-quarter 2024 conference call. (Operator Instructions) Please be advised today's conference being recorded.

美好的一天，感謝您的支持。歡迎參加 Moderna 2024 年第二季電話會議。 （操作員指示）請注意今天的會議正在錄製。

I would now like to hand the conference over to your 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 second-quarter 2024 financial results and business update. 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 的 2024 年第二季度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; Jamey Mock, our Chief Financial Officer; and Stephen Hoge, our President.

我們的執行長 Stéphane Bancel 出席了今天的電話會議； Jamey Mock，我們的財務長；和我們的總統史蒂芬霍格。

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

在我們開始之前，請注意，本次電話會議將包括根據1995 年《私人證券訴訟改革法案》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 Stephane.

我現在將把電話轉給史蒂芬。

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of our business. Jamey will present our financial results for the quarter and thank you for our based financial framework. There will then review our clinical progress. I will then close by sharing our commercial progress and our outlook for major upcoming milestones.

謝謝你，拉維娜。大家早安或下午好。感謝您今天加入我們。我將從回顧我們的業務開始。 Jamey 將介紹我們本季的財務業績，並感謝您提供我們的財務架構。然後將審查我們的臨床進展。最後，我將分享我們的商業進展以及對即將到來的主要里程碑的展望。

In the second quarter of 2024, our respiratory franchise has shown remarkable progress and is poised to positively impact millions of lives globally each year. This is why we started Moderna to impact patients, and that is why the Moderna team is so focused on execution because of that profound impact on so many lives.

2024 年第二季度，我們的呼吸產品系列取得了顯著進展，每年可望對全球數百萬人的生活產生積極影響。這就是為什麼我們創辦 Moderna 來影響患者，這就是為什麼 Moderna 團隊如此專注於執行，因為它對許多人的生活產生了深遠的影響。

[2023] vaccine, SPIKEVAX, continues to play a critical role in combating COVID. Based on CDC data provision just ending October '23 to June '24, COVID continues to result in higher hospitalization than other respiratory viruses. We are pleased that the RSV vaccine with brand name, mRESVIA, our second respiratory product has launched in the US and has now shipped to US customers. It is poised to impact public health in the US this year and soon, in many other countries for many years to come.

[2023] 疫苗 SPIKEVAX 在對抗新冠肺炎方面繼續發揮關鍵作用。根據 CDC 提供的數據，截至 2023 年 10 月至 24 年 6 月，新冠肺炎導致的住院人數持續高於其他呼吸道病毒。我們很高興我們的第二款呼吸道產品，品牌為 mRESVIA 的 RSV 疫苗已在美國上市，現已發貨給美國客戶。它預計將在今年影響美國的公共衛生，並很快在未來許多年影響許多其他國家的公共衛生。

Our flu vaccine candidate, mRNA-1010, has demonstrated positive Phase III results, meeting all immunogenicity endpoints in adults, 18 and older. Our flu-plus-COVID combo vaccine candidate, mRNA-1083, has also shown positive results in Phase III, underscoring our ability to innovate and tackle multiple respiratory illnesses effectively.

我們的候選流感疫苗 mRNA-1010 已顯示出積極的 III 期結果，滿足 18 歲及以上成人的所有免疫原性終點。我們的流感加新冠肺炎組合候選疫苗 mRNA-1083 在 III 期臨床試驗中也取得了積極成果，突顯了我們有效創新和應對多種呼吸道疾病的能力。

These achievements highlight the strength of our mRNA platform and our commitment to public health. We are now five out of five vaccines with positive Phase III data, COVID, RSV, flu, next-gen COVID, [mRNA-73] and our flu-plus-COVID combo.

這些成就凸顯了我們 mRNA 平台的實力以及我們對公共衛生的承諾。我們現在有五分之五的疫苗具有積極的 III 期數據，包括 COVID、RSV、流感、下一代 COVID、[mRNA-73] 以及我們的流感加 COVID 組合疫苗。

We are very excited about these achievements and are very thankful for our teams. We believe our technology has a potential to significantly reduce the burden of these respiratory diseases globally and saved millions of people around the world and thus impacting millions of families.

我們對這些成就感到非常興奮，也非常感謝我們的團隊。我們相信，我們的科技有潛力顯著減輕全球這些呼吸道疾病的負擔，拯救世界各地數百萬人的生命，進而影響數百萬家庭。

Moving to business highlights for Q2. We manufactured the '24, '25 season COVID vaccine targeting both the KP.2 and JN.1 strength of a virus. We are ready to meet the demand of a '24, '25 respiratory season.

轉向第二季的業務亮點。我們生產了針對 KP.2 和 JN.1 病毒強度的 24、25 季新冠疫苗。我們已準備好滿足「24、25」呼吸季節的需求。

In addition to our approval in the US, we are pleased that mRESVIA received a positive opinion from Europe regulatory agency, EMA with CHMP. We are waiting for regulatory approvals in additional countries around the world.

除了在美國獲得批准外，我們很高興 mRESVIA 還獲得了歐洲監管機構 EMA 和 CHMP 的正面評價。我們正在等待世界其他國家的監管部門批准。

For (inaudible), we recently announced a partnership in the US with BARDA to address H5 influenza virus and future public health spreads. The agreement awarded Moderna $176 million in funding to accelerate the development of mRNA-based pandemic flu vaccines.

對於（聽不清楚），我們最近宣佈在美國與 BARDA 建立合作夥伴關係，以應對 H5 流感病毒和未來的公共衛生傳播。該協議授予 Moderna 1.76 億美元的資金，以加速基於 mRNA 的大流行流感疫苗的開發。

Lastly, our Japanese partnership with Mitsubishi Tanabe Pharma Corporation is an important collaboration. With this joint agreement, we will co-promote Moderna respiratory vaccines in Japan, expanding our reach and impact in the Japanese market.

最後，我們與三菱田邊製藥公司的日本合作關係是一次重要的合作。透過這項聯合協議，我們將在日本共同推廣 Moderna 呼吸道疫苗，擴大我們在日本市場的覆蓋範圍和影響力。

In Q2, our revenues were up $241 million, which continue to reflect the highly seasonal nature of our respiratory vaccine business. The net loss was $1.3 billion. We ended the quarter with $10.8 billion, [mainly] the strong cash and investment position. This robust financial foundation allows us to continue investing in our key programs and initiatives.

第二季度，我們的營收成長了 2.41 億美元，這繼續反映了我們呼吸道疫苗業務的高度季節性。淨虧損為13億美元。本季結束時，我們的營收為 108 億美元，[主要是]強勁的現金和投資狀況。這一強大的財務基礎使我們能夠繼續投資於我們的關鍵計劃和舉措。

Additionally, we continue to make considerable progress in reducing our operating expenses. Compared to Q2 2023, we have decreased our operating expenses by more than $600 million in Q2 2024. This reduction highlights our commitment to operational efficiency and financial discipline.

此外，我們在減少營運費用方面繼續取得重大進展。與 2023 年第二季相比，2024 年第二季我們的營運費用減少了超過 6 億美元。

Before I hand over to Jamey, I want to touch on an announcement we made last week. We are very pleased and proud to welcome David Rubenstein, the Co-Founder and Co-Chairman of the Carlyle Group to Moderna Board starting next week. David has decades of experience investing and growing businesses across a number of industries.

在我把話題交給傑米之前，我想談談我們上週發布的一項公告。我們非常高興且自豪地歡迎凱雷投資集團聯合創始人兼聯合董事長大衛魯賓斯坦 (David Rubenstein) 從下週開始加入 Moderna 董事會。 David 擁有數十年在多個行業投資和發展業務的經驗。

He is also one of the most respected voices globally on matters related to international affairs and public policy. We are very excited to have join us to help us build Moderna to reach to the next level.

他也是國際事務和公共政策相關議題上全球最受尊敬的聲音之一。我們非常高興能夠加入我們，幫助我們將 Moderna 建造到一個新的水平。

With David joining the Board, Stephen Berendsen is stepping down from the Board and I would like to personally thank him for his many contributions during his tenure, including through the pandemic.

隨著 David 加入董事會，Stephen Berendsen 將辭去董事會職務，我謹親自感謝他在任職期間（包括在疫情期間）所做的許多貢獻。

We also announced that Bob Langer has informed the Board of the intention to retire from the Board. As one of our co-founder, Bob has made incredible contributions to Moderna and will not be the company we are today without his vision and insights. I am personally very grateful to Bob or coaching and mentoring, especially during the early years of Moderna, whereas experience was so valuable to me.

我們還宣布，鮑勃·蘭格 (Bob Langer) 已通知董事會其打算從董事會退休。作為我們的聯合創始人之一，鮑勃為 Moderna 做出了令人難以置信的貢獻，如果沒有他的遠見和洞察力，就不會擁有我們今天的公司。我個人非常感謝 Bob 的指導和指導，尤其是在 Moderna 的早期，而經驗對我來說非常寶貴。

With that, let me turn to Jamey.

接下來，讓我談談傑米。

Thanks, Stéphane, and hello, everyone. Today, I will walk you through our financial performance for the second quarter and also update you on our financial outlook for the remainder of 2024. Let me start with our commercial performance on slide 9.

謝謝，Stéphane，大家好。今天，我將向您介紹我們第二季的財務業績，並向您介紹我們 2024 年剩餘時間的財務前景。

Net product sales for Q2 were $184 million, down 37% year over year, mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside of the United States compared to the second quarter of 2023 when we fulfilled orders from prior year contracts. Q2 sales were above our guidance of approximately $100 million, primarily due to stronger-than-expected sales in the United States. We recognized sales from a number of other countries, including a small portion of the Brazil contract we announced last quarter.

第二季產品淨銷售額為 1.84 億美元，年減 37%，主要是由於與 2023 年第二季我們履行上一年合約訂單時相比，美國以外地區的 COVID-19 疫苗銷量下降。第二季銷售額高於我們約 1 億美元的指引，主要是因為美國的銷售額強於預期。我們確認了來自其他許多國家的銷售，包括我們上季度宣布的巴西合約的一小部分。

Year to date, sales were $351 million, down 83% year over year, largely driven by the same Q2 year-over-year trends I just mentioned a moment ago.

年初至今，銷售額為 3.51 億美元，年減 83%，這主要是由我剛才提到的第二季同比趨勢推動的。

Moving to Slide 10. As I just explained that product sales were $184 million, in Q2, we recognized $35 million of licensing revenue, which is included in the other revenue line of $57 million. This revenue comes from a non-exclusive intellectual property out-licensing agreement with a leading pharmaceutical company in Japan announced in our Q1 earnings call. The deal includes an upfront payment and low double-digit royalties on net sales of their COVID-19 product in Japan.

轉到投影片 10。該收入來自我們在第一季財報電話會議上宣布的與日本一家領先製藥公司簽訂的非獨家智慧財產權授權協議。該交易包括預付款和日本 COVID-19 產品淨銷售額兩位數的低特許權使用費。

For the second quarter of 2024, our cost of sales was $115 million, which included $10 million of third-party royalties, $55 million related to unutilized manufacturing capacity and wind-down costs, and $14 million of inventory write-offs. This resulted in our cost of sales representing 62% of net product sales.

2024 年第二季度，我們的銷售成本為1.15 億美元，其中包括1,000 萬美元的第三方特許權使用費、與未利用的製造能力和停產成本相關的5,500 萬美元，以及1,400 萬美元的庫存沖銷。這導致我們的銷售成本佔產品淨銷售額的 62%。

As a result of our initiative to resize our manufacturing cost structure, cost of sales was down 84% from Q2 last year when cost of sales was 249%. R&D expenses were $1.2 billion in Q2, reflecting a slight increase of $73 million or 6% year over year. We purchased a priority review voucher during the second quarter, which is included in our Q2 results.

由於我們主動調整製造成本結構，銷售成本比去年第二季的 249% 下降了 84%。第二季研發費用為 12 億美元，較去年同期微增 7,300 萬美元，增幅 6%。我們在第二季購買了優先審查券，該券包含在我們第二季的業績中。

With first half R&D spending at $2.3 billion, we are tracking towards the full-year expected spend of approximately $4.5 billion. SG&A expenses for Q2 were $268 million, reflecting a 19% decrease year-over-year. This reduction is a result of our continued strong focus on cost discipline and strategic investments driving productivity on which I will provide additional detail in the upcoming slides.

上半年研發支出為 23 億美元，我們預計全年支出約 45 億美元。第二季的 SG&A 費用為 2.68 億美元，年減 19%。這一減少是我們持續大力關注成本控制和策略投資以提高生產力的結果，我將在接下來的幻燈片中提供更多詳細資訊。

We reported zero income tax expense for the second quarter of 2024 compared to an income tax benefit of $369 million in the same period last year. The shift is primarily due to the continued application of a 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 年第二季所得稅費用為零，去年同期所得稅優惠為 3.69 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。

Our net loss for the period was $1.3 billion, an improvement from the net loss of $1.4 billion recorded last year. Loss per share was $3.33 compared to a loss of $3.62 in the second quarter of 2023. We ended Q2 with cash and investments totaling $10.8 billion down from $12.2 billion at the end of Q1, primarily due to ongoing research and development expenses and operating activities.

我們這段期間的淨虧損為 13 億美元，比去年錄得的 14 億美元淨虧損有所改善。每股虧損為3.33 美元，而2023 年第二季為虧損3.62 美元。的研發費用和營運活動。

Moving to slide 11 and similar to Q1, I want to provide additional detail on the cost reductions we are driving across the company. You can see in our Q2 results that we had a 19% year-over-year reduction in SG&A spend due to efficiency gains.

轉到幻燈片 11，與第一季類似，我想提供有關我們在整個公司推動的成本削減的更多詳細資訊。您可以在我們第二季的業績中看到，由於效率提升，我們的 SG&A 支出年減了 19%。

One of the main drivers for the year-over-year reduction in SG&A is from our commercial and medical affairs group. Over the past year, we have built our internal capabilities, which has allowed us to drive cost efficiencies by reducing our use of external consultants and other purchase services. We've also been more focused and targeted on how we invest in this area to drive the strongest possible return on investment.

SG&A 年比減少的主要驅動力之一來自我們的商業和醫療事務團隊。在過去的一年裡，我們建立了內部能力，這使我們能夠透過減少對外部顧問和其他採購服務的使用來提高成本效率。我們也更加專注和有針對性地關注如何在這一領域進行投資，以實現盡可能強勁的投資回報。

And as the endemic market has been more seasonal, we have shifted more of our commercial spend into the second half of the year. Additionally, our procurement team has successfully driven company-wide cost reductions in the first half of 2024. Their primary focus has been on reducing third-party supplier rates and we have seen strong progress in contract rates for raw materials, components, clinical, travel and consulting services.

由於流行市場的季節性更強，我們已將更多的商業支出轉移到下半年。此外，我們的採購團隊在2024 年上半年成功推動了全公司成本降低。進展和諮詢服務。

We continue to see strong adoption in artificial intelligence by our employees. which will allow us to scale the business in an efficient manner with a digital-first mindset. For example, in the second quarter, our HR team launched benefits and equity GPs. These AI-driven assistants are designed to handle frequently asked questions previously directed to the HR operations team and allow us to scale efficiently.

我們繼續看到我們的員工大力採用人工智慧。這將使我們能夠以數位優先的思維方式有效地擴展業務。例如，在第二季度，我們的人力資源團隊推出了福利和股權GP。這些人工智慧驅動的助手旨在處理先前向人力資源營運團隊提出的常見問題，並使我們能夠有效地擴展規模。

Overall, we have built a solid foundation and made purposeful investments in people, processes, and technology. We highlighted some of the significant drivers of the 2Q SG&A savings but we are also seeing additional efficiency savings in R&D and manufacturing. I'm very pleased with the cost savings results in the first half of the year and want to thank our Moderna teams.

總體而言，我們已經建立了堅實的基礎，並在人員、流程和技術方面進行了有針對性的投資。我們強調了第二季銷售管理費用節省的一些重要驅動因素，但我們也看到研發和製造的額外效率節省。我對上半年的成本節省結果感到非常滿意，並感謝我們的 Moderna 團隊。

Now let's turn to our 2024 financial framework on slide 12. We are revising our expectations for 2024 net product sales to a range of $3.0 billion to $3.5 billion. There are three primary drivers for the updated outlook.

現在讓我們轉向投影片 12 上的 2024 年財務架構。更新的前景有三個主要驅動因素。

First, we are now expecting very low sales in 2024 from EU member states based on recent feedback and discussions with country health officials. Second, in the US, we are seeing increased competitive pressures for our respiratory vaccines. While this has led to a slower RSD ramp than previously anticipated, we continue to believe in mRESVIA's long-term potential.

首先，根據最近的回饋以及與國家衛生官員的討論，我們預計 2024 年歐盟成員國的銷售額將非常低。其次，在美國，我們看到呼吸道疫苗的競爭壓力越來越大。雖然這導致 RSD 成長速度比之前預期的要慢，但我們仍然相信 mRESVIA 的長期潛力。

Third, in the rest of the world, we have provided for the potential risk of revenue deferrals from 2024 into 2025. We remain committed in our attempt to mitigate these risks but believe it's appropriate to adjust our guidance at this time. Finally, this revenue framework assumes a US COVID vaccination rate similar to last season.

第三，在世界其他地區，我們已經考慮到了收入從 2024 年推遲到 2025 年的潛在風險。最後，該收入框架假設美國新冠疫苗接種率與上一季相似。

Our second half sales mix will be dependent on timing of regulatory approvals across the world and the number of days available in the third quarter to ship. We currently expect a remaining sales split of 40% to 50% in Q3 with the balance in Q4. We expect cost of sales as a percentage of product sales for the full year to be in the range of 40% to 50% based upon our updated sales range.

我們下半年的銷售組合將取決於全球監管機構批准的時間以及第三季的可用出貨天數。我們目前預計第三季剩餘銷售佔比為 40% 至 50%，其餘部分將在第四季實現。根據我們更新的銷售範圍，我們預計全年銷售成本佔產品銷售額的百分比將在 40% 至 50% 之間。

For R&D, we continue to expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. For SG&A, we continue to expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023.

對於研發，我們繼續預期全年支出約為45 億美元，低於2023 年的48 億美元。美元。

Note that we expect SG&A to be higher in the second half versus the first half, primarily due to increased commercial activity, but still expect the second half to be down on a year-over-year basis. We continue to expect taxes to be negligible in 2024 and capital expenditures to be approximately $0.9 billion.

請注意，我們預計下半年的銷售管理費用將高於上半年，這主要是由於商業活動增加，但仍預計下半年將年減。我們仍預期 2024 年的稅收可以忽略不計，資本支出約為 9 億美元。

Finally, we continue to expect that we will end 2024 with approximately $9 billion in cash. We have made strong progress in improving our working capital management, which is offsetting the change in our product sales outlook.

最後，我們仍然預計 2024 年底我們將擁有約 90 億美元的現金。我們在改善營運資金管理方面取得了巨大進展，這抵消了我們產品銷售前景的變化。

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 in three of the four development areas in our portfolio. In the second quarter, we had important updates in respiratory vaccines, oncology, and rare diseases.

謝謝你，傑米。今天，我將回顧我們投資組合中四個開發領域中三個領域的臨床項目的最新情況。第二季度，我們在呼吸道疫苗、腫瘤學和罕見疾病方面取得了重要進展。

Starting with respiratory vaccines. We are very pleased by the approval and ACIP recommendation for our RSV vaccine, mRESVIA.

從呼吸道疫苗開始。我們對我們的 RSV 疫苗 mRESVIA 獲得批准和 ACIP 推薦感到非常高興。

In the US, for all unvaccinated adult, 75 years and older; and in unvaccinated adults, 60 to 74 years of age, wera an increased risk from RSV. This recommendation was the same as for the other two previously approved RSV vaccines. We also recently received a positive CHMP opinion from the European Medicines Agency for mRESVIA. And as Stephane mentioned earlier, we are working towards approvals in additional countries.

在美國，針對所有未接種疫苗的 75 歲及以上成年人； 60 至 74 歲未接種疫苗的成年人感染 RSV 的風險增加。該建議與先前批准的其他兩種 RSV 疫苗相同。我們最近也收到了歐洲藥品管理局對 mRESVIA 的積極的 CHMP 意見。正如 Stephane 之前提到的，我們正在努力爭取在更多國家/地區獲得批准。

Turning to flu. We are in discussions with multiple regulatory authorities and intend to file in 2024. For our next-generation COVID vaccine, mRNA-1083, we announced positive Phase III efficacy results demonstrating non-inferior efficacy against COVID-19 compared to SPIKEVAX in all trial participants, 12 years of age and older. Efficacy was higher than SPIKEVAX in adults 18 years and older.

轉向流感。我們正在與多個監管機構進行討論，並打算在2024 年提交申請。比，對COVID-19 的療效不較差，12 歲以上。對於 18 歲及以上的成年人來說，療效高於 SPIKEVAX。

We are excited by the data and are sharing the results with regulators and intend to file for approval beginning in 2024.

我們對這些數據感到興奮，正在與監管機構分享結果，並打算從 2024 年開始申請批准。

Rounding out the news and respiratory vaccines development. In the quarter, we shared positive results from our Phase III trial with our combination flu and COVID vaccine. The trial met its primary immunogenicity endpoints with the combination vaccine eliciting higher immune responses against flu and Sars-CoV-2 than the licensed flu and licensed co-vaccine, given separately in adults 50 years of age and older in the trial.

完善新聞和呼吸道疫苗的開發。本季度，我們分享了流感和新冠疫苗聯合疫苗 III 期試驗的正面結果。該試驗達到了主要免疫原性終點，與在試驗中分別給予50 歲及以上成年人的經許可的流感疫苗和經許可的聯合疫苗相比，聯合疫苗能引發更高的針對流感和Sars-CoV -2 的免疫反應。

In the subset of participants 65 years of age and older, our combination of vaccine also elicits higher immune responses than an enhanced flu vaccine that is recommended in the 65 and older age group in many countries, including the United States. These results are exciting, and we have begun sharing them with regulators and planning for the next steps.

在 65 歲及以上的參與者子集中，我們的疫苗組合也比許多國家（包括美國）推薦給 65 歲及以上年齡組的增強型流感疫苗引發更高的免疫反應。這些結果令人興奮，我們已開始與監管機構分享這些結果並規劃下一步。

Turning now to oncology. In the quarter, we shared an update on our mRNA-4157 program, also known as INT, which elicits antitumor T cell responses by targeting a patient's unique tumor mutations or neoantigens.

現在轉向腫瘤學。在本季度，我們分享了 mRNA-4157 計畫（也稱為 INT）的更新，該計畫透過針對患者獨特的腫瘤突變或新抗原來引發抗腫瘤 T 細胞反應。

INT is in multiple large, randomized trials, including two Phase III trials, one in adjuvant melanoma and the other adjuvant non-small cell lung cancer; one Phase II/III trial in adjuvant cutaneous squamous cell carcinoma; and two randomized Phase II studies, one in adjuvant kidney cancer and the other in bladder cancer. We and our partner, Merck, expect to start additional studies in new tumor types.

INT 正在進行多項大型隨機試驗，包括兩項 III 期試驗，一項針對輔助黑色素瘤，另一項針對輔助非小細胞肺癌；一項針對輔助性皮膚鱗狀細胞癌的 II/III 期試驗；以及兩項隨機 II 期研究，一項針對輔助腎癌，另一項針對膀胱癌。我們和我們的合作夥伴默克公司預計將開始針對新腫瘤類型的更多研究。

The development program has launched on the back -- was launched on the back of impressive randomized Phase II trial results in adjuvant melanoma. We recently shared the three-year follow-up data from that trial at ASCO this past June. And on the next few slides, I will quickly summarize the highlights from that presentation.

該開發計劃是在輔助黑色素瘤隨機 II 期試驗取得令人印象深刻的結果後啟動的。我們最近分享了今年 6 月在 ASCO 進行的試驗的三年追蹤數據。在接下來的幾張投影片中，我將快速總結該簡報的亮點。

The primary clinical endpoint for the Phase II adjuvant melanoma study is recurrence-free survival or RFS. As presented at ASCO, there is a sustained improvement in RFS with the combination of INT plus KEYTRUDA versus KEYTRUDA alone through three years of follow-up.

II 期輔助黑色素瘤研究的主要臨床終點是無復發生存期或 RFS。正如 ASCO 上所介紹的，在三年的追蹤中，與單獨使用 KEYTRUDA 相比，INT 加 KEYTRUDA 組合的 RFS 得到了持續改善。

74.8% of patients receiving the combination treatment of IT plus KEYTRUDA world live and tumor-free at three years, which was 19 percentage points higher than KEYTRUDA alone, and resulted in an impressive hazard ratio of plus 0.51.

接受 IT 加 KEYTRUDA 合併治療的患者中，有 74.8% 在三年內存活且無腫瘤，比單獨使用 KEYTRUDA 高出 19 個百分點，並導致令人印象深刻的風險比 + 0.51。

The combination of INT plus KEYTRUDA also showed sustained improvement in distant metastasis-free survival at three years. 89.3% of patients in combination INT plus KEYTRUDA treatment group were alive and without metastases or distance spread of their tumor at three years of follow-up versus 68.7% of patients in the KEYTRUDA monotherapy group. This is an equally impressive and remarkable hazard ratio of 0.38.

INT 聯合 KEYTRUDA 的組合也顯示出三年無遠端轉移存活率的持續改善。三年追蹤時，INT 加 KEYTRUDA 合併治療組有 89.3% 的患者存活且沒有腫瘤轉移或遠端擴散，而 KEYTRUDA 單藥治療組中這一比例為 68.7%。 0.38 的風險比同樣令人印象深刻且引人注目。

We were lastly pleased to share data showing that an early favorable trend in overall survival at three years of follow-up.

最後，我們很高興分享數據，顯示三年追蹤中整體存活率出現早期有利趨勢。

Now finally, on the safety side, INT continues to demonstrate a remarkable profile for our novel cancer therapy. Immune-related adverse events were not [found] in the combination INTs plus KEYTRUDA arm despite the benefits than in the KEYTRUDA monotherapy arm. This highlights the impressive emerging benefit risk profile for our INT program.

最後，在安全性方面，INT 繼續展示我們新型癌症療法的卓越表現。儘管 INT 合併 KEYTRUDA 治療組比 KEYTRUDA 單藥治療組有益，但並未[發現]免疫相關不良事件。這突顯了我們的 INT 計劃令人印象深刻的新興效益風險狀況。

Moving now to rare diseases. I'm happy to share that our MMA-candidate mRNA-3705 was selected for the FDA STAR program. M&A is a rare disease in which patients cannot properly break down proteins from the food and digest. As a result, toxins build up in the bloodstream and cause recurrent episodes of life-threatening metabolic decompensation.

現在轉向罕見疾病。我很高興與大家分享，我們的 MMA 候選藥物 mRNA-3705 已入選 FDA STAR 計劃。併購是一種罕見疾病，患者無法正確分解和消化食物中的蛋白質。結果，毒素在血液中積聚，並導致危及生命的代謝失代償的反覆發作。

The FDA START program is a program designed to accelerate development of new and promising therapies in rare diseases, where there is a high unmet need. Our MMA candidate, mRNA-3705, is being evaluated in patients in a Phase I/II study with encouraging early results that we've previously shared. And we look forward to working with the FDA to accelerate the development of this promising potential medicine.

FDA START 計劃旨在加速罕見疾病新療法的開發，這些疾病的需求尚未得到滿足。我們的 MMA 候選藥物 mRNA-3705 正在 I/II 期研究中對患者進行評估，並取得了我們先前分享的令人鼓舞的早期結果。我們期待與 FDA 合作，加速這一有前景的潛在藥物的開發。

With that, I'll now turn it back to Stephane.

有了這個，我現在將其轉回給史蒂芬。

Thank you, Stephen and Jamey. Let's start with COVID -- with the start of the COVID season only a few weeks away, contracting for the season is almost completed as we speak. In the US, we have seen increased competitive pressure during the contracting season compared to last year, and we have not finalized most of the contracts. We are working closely with public officials, healthcare providers, pharmacies to drive vaccination rates. Our collaborative efforts with these stakeholders are critical in driving widespread taxation adoption.

謝謝你們，史蒂芬和傑米。讓我們從新冠疫情開始——距離新冠疫情季節的開始只有幾週的時間，就在我們說話的時候，本賽季的合約即將完成。在美國，與去年相比，我們在合約季的競爭壓力有所增加，而且我們大部分合約尚未敲定。我們正在與政府官員、醫療保健提供者、藥局密切合作，以提高疫苗接種率。我們與這些利害關係人的合作對於推動稅收的廣泛採用至關重要。

In the EU, we're in advanced discussions on the tender framework to provide market access. However, based on recent feedback from several large governments, we are now expecting variable sales to EU member states in 2024. Some large countries will not buy SPIKEVAX for '24, 25 season.

在歐盟，我們正在就提供市場准入的招標框架進行深入討論。然而，根據最近幾個大國政府的回饋，我們目前預計 2024 年對歐盟成員國的銷售量會有所變化。

In the rest of the world, we have multiple signed contracts in place, some of which could be deferred into 2025. Contracting discussions are ongoing with some additional countries, but we do not expect this to have a significant impact on an updated sales framework.

在世界其他地區，我們已簽署多份合同，其中一些合同可能會推遲到 2025 年。

Moving now to the launch preparation for the '24, '25 season. Our organization is fully prepared for the upcoming season, thanks to a substantial effort made by the Moderna teams to ensure the global availability of COVID vaccine.

現在開始為「24」、「25」賽季進行發布準備。由於 Moderna 團隊為確保新冠疫苗在全球範圍內的供應做出了巨大努力，我們的組織已為即將到來的季節做好了充分準備。

In North America, we are ready to supply SPIKEVAX targeting KP.2 strain, advised by the FDA, demonstrating our ability to quickly develop and manufacture SPIKEVAX for selected strengths. In the rest of the world, we are supplying vaccine targeting the JN.1 strain as requested by [regulators] in those regions.

在北美，我們已準備好根據 FDA 的建議提供針對 KP.2 菌株的 SPIKEVAX，這證明了我們針對特定優勢快速開發和製造 SPIKEVAX 的能力。在世界其他地區，我們正在按照這些地區[監管機構]的要求提供針對 JN.1 株的疫苗。

Let me now take you through details on the US COVID market. We'll be ready to supply millions of doses to all segments of the US market upon regulatory approval. Our goal is to ensure that SPIKEVAX is available to all customers, larger pharmacies, independent pharmacies, healthcare professionals, IDN hospital network, public health entities at the same time, facilitating early in widespread vaccination. Securing the wider system to be ready to vaccinate is a key priority for us this season.

現在讓我帶您了解美國新冠市場的詳細情況。在獲得監管部門批准後，我們將準備好向美國市場的所有細分市場供應數百萬劑疫苗。我們的目標是確保所有客戶、大型藥局、獨立藥局、醫療保健專業人員、IDN 醫院網路、公共衛生實體同時可以使用 SPIKEVAX，從而促進早期廣泛接種疫苗。確保更廣泛的系統做好疫苗接種準備是我們本賽季的首要任務。

To that line, we have implemented a real-time order tracking system which is available to all of our customers and provide detailed information on every order, including real timing, package size, and temperature status.

為此，我們實施了實時訂單追蹤系統，該系統可供所有客戶使用，並提供每個訂單的詳細信息，包括實時時間、包裹尺寸和溫度狀態。

Our supply chain are using AI tools to help estimate the optimal order of distribution to locations within the US market. These preparations highlight our commitment to ensuring the broad availability of buybacks and meeting market demand.

我們的供應鏈正在使用人工智慧工具來幫助估計美國市場內各個地點的最佳配送順序。這些準備工作凸顯了我們對確保廣泛回購和滿足市場需求的承諾。

Let me now turn to our marketing efforts. We believe education and awareness campaigns will be important drivers to increase vaccination rates. We have started these efforts early. For end of the season, we have launched a back-to-basics campaign. This initiative is designed to raise awareness about how the SARS-CoV-2 works and why it is critical to get a new booster each year like for flu.

現在讓我談談我們的行銷工作。我們相信教育和宣傳活動將成為提高疫苗接種率的重要驅動力。我們很早就開始了這些努力。在賽季結束時，我們發起了一場回歸基礎的活動。該舉措旨在提高人們對 SARS-CoV-2 工作原理的認識，以及為什麼每年像流感一樣獲得新的加強針至關重要。

The virus could change over time, and we need to have a new tool to boost our immune system, the new mutations to reduce infection, reduce hospitalization, and reduce deaths. Additionally, we are working with public care authorities to educate the public on the impact of long COVID, highlighting how vaccine can help reduce risk for young and middle-aged adults.

病毒可能會隨著時間的推移而發生變化，我們需要一種新的工具來增強我們的免疫系統，新的突變可以減少感染、減少住院和減少死亡。此外，我們正在與公共保健機構合作，教育大眾了解長期新冠病毒的影響，並強調疫苗如何幫助降低年輕人和中年人的風險。

Soon, we will start our in-season outreach to high-risk groups. By collaborating with major retail pharmacies, we aim to effectively market our products during the season. This targeted approach ensures that our efforts are focused on those who are the most vulnerable, maximizing the benefits of vaccination for those groups. By leveraging major channels, we aim to reach a broader audience and emphasize the critical need for vaccination to mitigate severe outcomes.

很快，我們將開始對高風險群體進行季節性外展活動。透過與主要零售藥局合作，我們的目標是在季節期間有效地行銷我們的產品。這種有針對性的方法確保我們的努力集中在最脆弱的人群上，最大限度地為這些群體帶來疫苗接種的好處。透過利用主要管道，我們的目標是覆蓋更廣泛的受眾，並強調接種疫苗以減輕嚴重後果的迫切需求。

Let me now turn to our RSV launch. We are very excited about the launch of our second product, mRESVIA. Following the approval, the ACIP vaccine recommendation on par with competitor vaccines. Specifically, ACIP recommended a single dose of RSV vaccine for all unvaccinated adults, age 75 and above. ACIP has commodity a single dose for unpainted adults between the age of 60 and 74, who are at an increased risk.

現在讓我談談我們的 RSV 發布。我們對第二款產品 mRESVIA 的推出感到非常興奮。獲得批准後，ACIP 疫苗推薦與競爭對手疫苗相當。具體來說，ACIP 建議所有未接種疫苗的 75 歲及以上成年人接種單劑 RSV 疫苗。 ACIP 為 60 至 74 歲之間風險較高的未塗漆成年人提供了單劑量商品。

Based on this recommendation, approximately 40 million people in the US are eligible for vaccination. The RV market size beyond the '24, '25 season will depend on the revaccination recommendation, which are anticipated to be discussed by ACIP in future meetings.

根據這項建議，美國約有 4000 萬人有資格接種疫苗。 24、25 賽季後的房車市場規模將取決於重新接種疫苗的建議，預計 ACIP 將在未來的會議上討論這些建議。

In RSV, our focus into direct our efforts to the segments with the vast majority of our vaccinations occur. In the US, we are targeting the pharmacy segment, which includes both large retail chains as well as independent pharmacies. Together, total pharmacy segment accounted last year for around 95% of our RSV vaccine administration.

在 RSV 中，我們的重點是將我們的努力集中在絕大多數疫苗接種發生的部分。在美國，我們的目標是藥房市場，其中包括大型零售連鎖店和獨立藥房。去年，整個藥局部門占我們 RSV 疫苗管理量的 95% 左右。

We began shipping products in pharmacy in July. And as Jamey mentioned earlier, we are seeing a highly competitive environment. Additionally, larger competitor contracts were negotiated prior to our approval and launch, resulting in lower 2024 share than we would have liked.

我們從七月開始在藥局運送產品。正如傑米之前提到的，我們看到了一個競爭激烈的環境。此外，在我們批准和推出之前就已經談判了更大的競爭對手合同，導致 2024 年的份額低於我們的預期。

Long term, we continue to believe our [PFS propagation] will resonate well with customers, offering them the ability to use the time, much more efficiently during the busy fall vaccination season and to reduce potential medical errors. We look forward to some major upcoming milestones in the near term.

從長遠來看，我們仍然相信我們的 [PFS 傳播] 將與客戶產生良好的共鳴，使他們能夠在繁忙的秋季疫苗接種季節更有效地利用時間，並減少潛在的醫療錯誤。我們期待近期即將到來的一些重大里程碑。

In respiratory vaccine, we expect a COVID approval, and we'll be ready to ship in the US and rest of the world in the August, September time frame. In RSV, we expect to release Phase III data for high-risk individuals, 18 years of age and above. We are in discussion with regulators on our [two] program and intent to file in 2024. We also expect to present immunogenicity data in other adults for flu vaccine versus (inaudible).

在呼吸道疫苗方面，我們預計將獲得新冠肺炎批准，並且我們將準備在 8 月、9 月的時間範圍內向美國和世界其他地區發貨。在 RSV 中，我們預計將發布 18 歲及以上高風險族群的 III 期數據。我們正在與監管機構討論我們的[兩個]計劃，並打算在 2024 年提交文件。

For next-gen COVID vaccine, mRNA-1083, we're engaging with regulators and incentive file in 2024. And combination of Flu-COVID vaccine, mRNA-1083, we're engaging regulators and also be able to give an update soon. With this vaccine with CMV fully enrolled and accruing cases, we look forward to potentially Phase III vaccine efficacy readout in 2024.

對於下一代新冠病毒疫苗 mRNA-1083，我們正在與監管機構合作並在 2024 年制定激勵文件。隨著這種 CMV 疫苗的完全入組和病例數的增加，我們期待 2024 年可能出現 III 期疫苗療效讀數。

And as Stephen just talked about, we are very excited about our INT program while looking forward to the completion of the element of a Phase III in adjuvant melanoma, which is, of course, a major milestone.

正如 Stephen 剛才所說，我們對 INT 計畫感到非常興奮，同時期待完成輔助黑色素瘤第三階段的部分內容，這當然是一個重要的里程碑。

We are keen to discuss regulators the possibility of accelerated approval based on the Phase II study data. As we shared before, there are three things with you as necessary before we could consider pursuing access of approval for INT. First, durability of data, which we believe that, as Stephen presented, we are there. Second, a substantially enrolled Phase III adjuvant melanoma study. And third, manufacturing readiness at our Marlborough site.

我們熱衷於與監管機構討論基於第二階段研究資料加速批准的可能性。正如我們之前分享的，在我們考慮尋求 INT 的批准之前，需要與您一起完成三件事。首先，數據的持久性，正如史蒂芬所言，我們相信我們已經做到了這一點。其次，一項大量入組的 III 期輔助黑色素瘤研究。第三，我們馬爾堡工廠的生產準備。

Lastly, in our rare disease portfolio, we look forward to initiating pivotal study for PA and MMA. We're eager to achieve these milestones and to continue to progress towards our mission to deliver the greatest possible impact to people for MRM medicine.

最後，在我們的罕見疾病組合中，我們期待啟動 PA 和 MMA 的關鍵研究。我們渴望實現這些里程碑，並繼續朝著我們的使命邁進，為 MRM 醫學帶來最大可能的影響。

We expect these new some events, combined with further advancement in our pipeline with confirmed power of our platform and its potential to serve patients for years to go. An important save-the-date for your calendar, our annual R&D Day will be held the morning of September 12 in New York City. Of course, webcast will also be available.

我們期待這些新的事件，再加上我們的管道的進一步進步，以及我們平台的強大力量及其在未來幾年為患者服務的潛力。我們一年一度的研發日將於 9 月 12 日上午在紐約舉行，這是您日曆上的一個重要日期。當然，也將提供網路直播。

Thank you for listening to the call. And we would like now with the team to take your questions. Operator?

感謝您收聽電話。現在我們希望與團隊一起回答您的問題。操作員？

(Operator Instructions) Salveen Richter, Goldman Sachs.

（操作員指令）Salveen Richter，高盛。

A couple for me here. Can you help us understand the factors contributing to maintenance of the year-end cash balance guidance following the lowered product revenue guidance range? And then with regard to competitive pressures noted regarding contracts for COVID into second half, can you be more specific on the factors here, whether it's contracting logistics or the clinical profile, competitive dynamics or what that might be? And third, how much visibility do you have on second half demand for the RSV vaccine based on contracting to date?

這裡有一對給我。您能否幫助我們了解在降低產品收入指引範圍後維持年終現金餘額指引的因素？然後，關於下半年新冠肺炎合約所面臨的競爭壓力，您能否更具體地說明這裡的因素，無論是合約物流還是臨床概況、競爭動態或可能是什麼？第三，根據迄今為止的合同，您對下半年 RSV 疫苗的需求有多少了解？

Yeah. So hi, Salveen, I'll take the first question regarding the year-end cash balance. So I would say there's a few factors in there. Number one, on the deferrals of revenue, some of which we have already collected the cash and ultimately, we will collect the remaining balance that might push into 2025, but some of that is already a prepayment.

是的。嗨，Salveen，我將回答有關年終現金餘額的第一個問題。所以我想說這裡面有幾個因素。第一，關於收入延期，其中一些我們已經收到了現金，最終我們將收到可能推遲到 2025 年的剩餘餘額，但其中一些已經是預付款。

Number two, as I mentioned in my prepared remarks, we have been working on working capital. We've got a whole team focused on it, and the teams are doing a great job from accounts payable, inventory balances, receivables and our collections progress, you can see our receivables balance on the balance sheet is relatively small at this point. So the team is doing a great job, which helps offset it.

第二，正如我在準備好的發言中提到的，我們一直在努力解決營運資金問題。我們有一個完整的團隊專注於此，團隊在應付帳款、庫存餘額、應收帳款和我們的收款進度方面做得很好，你可以看到我們的資產負債表上的應收帳款餘額此時相對較小。所以團隊做得很好，這有助於抵消它。

And then third, just coming into the year, we had a little bit of cushion to the $9 billion. So overall, we remain confident in the $9 billion and are pleased with that kind of ending balance heading into 2025.

第三，剛進入今年，我們對 90 億美元有點緩衝。因此，總體而言，我們對 90 億美元仍然充滿信心，並對 2025 年的期末餘額感到滿意。

And Salveen, I'll take the two other questions. It's Stephane. On the competitive pressure, I think on both products, COVID and RSV, we are seeing similar things, which is bundling from larger competitors with portfolio of products. [Inability], if you want to also be much more aggressive on activity with various supply chain, average pricing, wherever it's core marketing funding and all those activities.

Salveen，我將回答另外兩個問題。這是史蒂芬。在競爭壓力方面，我認為在新冠病毒和 RSV 這兩種產品上，我們看到了類似的情況，即與較大競爭對手的產品組合捆綁在一起。 [無能]，如果您還想在各種供應鏈、平均定價、核心行銷資金和所有這些活動的活動上更加積極主動。

So it's really a mix of the customer-to-customer level. We've just seen a much more intensive pressure of COVID versus last year.

所以這其實是客戶對客戶層面的混合。我們剛剛看到新冠疫情帶來的壓力比去年更加嚴重。

And on INT, as you know, we're entering the market where there's two large establish player, one with very large market share. We, of course, is trying to defend it. The other one who has indicated they want to gain market share because they are not pleased with market share last year. And so we have been working really actively on that.

如您所知，在 INT 上，我們正​​在進入一個市場，該市場有兩家大型老牌企業，其中一家擁有非常大的市場份額。當然，我們正在努力捍衛它。另一位表示他們希望獲得市場份額，因為他們對去年的市場份額不滿意。因此，我們一直在積極致力於這方面的工作。

In terms of visibility for RSV. We have some contracts that have already been signed and that we are actively supplying customers now that the product is shipped. There are some contracts that are being finalized with ability in season to demonstrate to the customer the value of PFS and to be able to move that into season.

就 RSV 的可見性而言。我們已經簽署了一些合同，產品已發貨，我們正在積極向客戶供貨。有些合約正在敲定，能夠在季節內向客戶展示 PFS 的價值，並能夠將其轉移到季節中。

So we're working through all those things. We'll provide updates as the season goes, but we don't think it is very important for patients. It's very important for the company. So we are all hands on deck on COVID and RSV.

所以我們正在解決所有這些問題。我們將隨著季節的推移提供更新，但我們認為這對患者來說不是很重要。這對公司來說非常重要。因此，我們全力應對新冠病毒和呼吸道合胞病毒。

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

Maybe two for me as well. I was just wondering on the guidance cut, if you can quantify how much was from COVID versus RSV? And then on the seasonal flu and the seasonal-flu-plus-COVID combo -- might be parsing words here, but on seasonal flu, I noticed the press release that intend to file in 2024, the combos that are engaging with regulators on next steps. So maybe you could just help us think through kind of the gating factors for each of those in the difference in language there.

也許對我來說也是兩個。我只是想知道指導意見的削減，你是否可以量化有多少是來自新冠病毒和呼吸道合胞病毒？然後是季節性流感和季節性流感加新冠病毒組合——可能在這裡解析單詞，但關於季節性流感，我注意到打算在 2024 年提交的新聞稿，這些組合正在與監管機構合作腳步。因此，也許您可以幫助我們思考語言差異中每個因素的控制因素。

Yes. Thanks, Terrence. I'll take the first one related to guidance. And what's the split between COVID and RSV. So what I would say is if you look at the three drivers, all of them are first, similar in size. And then if I break them down, the deferrals are all related to COVID. The EU is all related to COVID. And then that last category of competitiveness in RSV vaccine or respiratory vaccines is a split between COVID and RSV. So that should give you some understanding of the general split between COVID and RSV.

是的。謝謝，特倫斯。我將採取第一個與指導相關的內容。 COVID 和 RSV 之間有何區別？所以我想說的是，如果你看這三位車手，他們都是第一，大小相似。如果我詳細分析的話，延期都與新冠疫情有關。歐盟都與新冠病毒有關。 RSV 疫苗或呼吸道疫苗的最後一類競爭力是 COVID 和 RSV 之間的分歧。這應該能讓您對新冠病毒 (COVID-19) 和呼吸道合胞病毒 (RSV) 之間的一般差異有所了解。

Great. And for the question on the language, good pickup. So the 1083 flu coving program is the most recent Phase III results, really quite fresh. And we have just begun the process of engaging with regulators, meaning sharing that data and discussing with them what their expectations would be on submission.

偉大的。對於語言問題，很好。所以說1083流感疫苗計畫是最新的第三期成果，確實挺新鮮的。我們剛開始與監管機構接觸的過程，這意味著分享這些數據並與他們討論他們對提交數據的期望。

For the other programs that you referenced, obviously, have more time. Had some of those discussions, and we're obviously preparing for submissions as we said in our prepared remarks.

對於您引用的其他程序，顯然需要更多時間。進行了一些討論，正如我們在準備好的發言中所說，我們顯然正在準備提交。

Michael Yee, Jefferies.

麥可葉，杰弗里斯。

Two questions from us. Looking forward on guidance, you obviously have revenue guidance this year. You have OpEx guidance, which we see is around $6 billion of R&D and SG&A. And as you project out to the following years, you have already given cash flow guidance.

我們提出兩個問題。展望指導，今年顯然有收入指導。您有營運支出指導，我們認為研發和銷售、一般管理費用約為 60 億美元。當您預測未來幾年時，您已經給了現金流量指引。

So if things are generally staying along the same trajectory, I would think that cash guidance would be lower. Can you speak to the math there? And perhaps, Jamey, who has said you could flex OpEx, is that of heightened importance and heightened priority more aggressively as you think about where things stand today and the change in guidance and talk to that given cash guidance has been a concern for investors?

因此，如果事情整體保持相同的軌跡，我認為現金指導將會較低。你能講一下那裡的數學嗎？傑米（Jamey）曾表示，你可以靈活調整營運支出，當你考慮目前的情況以及指導意見的變化並討論鑑於現金指導意見一直是投資者所關心的問題時，這一點是否更加重要並更加積極地提高優先權？

The second question is going back to RSV. I appreciate the comments you just said, that was super helpful in breaking it down. Is that to say that the RSV projections you have are going to be perhaps in half? And is that due to lower share or lower price, and speak to that?

第二個問題回到RSV。我很欣賞你剛才所說的評論，這對分解它非常有幫助。這是否意味著您對 RSV 的預測可能會減半？這是由於較低的份額或較低的價格嗎？

Yeah. Thanks, Mike. So we are still -- as I mentioned, we're still expecting $9 billion in cash next year and don't currently have any different change in our outlook for the $6 billion to $7 billion that we said we'd end in 2025 with, and let me break that down.

是的。謝謝，麥克。因此，正如我所提到的，我們仍然預計明年將有 90 億美元的現金，目前我們對 2025 年預計將達到 60 億至 70 億美元的前景沒有任何不同的變化。

So first, this year, we went from the start of the year, $13 billion to $9 billion, so a $4 billion loss in cash. That included many pre-payments coming into the year that will no longer repeat. So we're not actually getting the cash from operations, and that won't be a drag year over year.

首先，今年我們的現金損失從年初的 130 億美元增加到 90 億美元，現金損失達 40 億美元。其中包括今年將不再重複的許多預付款。因此，我們實際上並沒有從營運中獲得現金，這不會逐年拖累。

Second, we plan to return to growth in 2025. And as I mentioned earlier, some of that will also be moved by the fact that we have some deferrals heading into 2025. But more so, we'll have an entire year and operating experience on RSV, we hope to bring new products to market, and so we're still expecting to return to growth.

其次，我們計劃在2025 年恢復成長。經驗在 RSV 上，我們希望將新產品推向市場，因此我們仍然期望恢復成長。

But yes, I mean, we continue to look at OpEx and understand what we want to do there, and we are always laser-focused on our cash balance. And at this time, we don't think the $6 billion to $7 billion will change.

但是，是的，我的意思是，我們繼續專注於營運支出並了解我們想在那裡做什麼，並且我們始終專注於我們的現金餘額。目前，我們認為 60 億至 70 億美元不會改變。

Okay. And then on to be breaking it down, just a little more specifics, on the impact of market share contracting and price and how to think about that.

好的。然後將其分解，更多細節，關於市場份額收縮和價格的影響以及如何思考這一點。

Yah, a bit of both. We're not breaking it down nor have we given guidance on RSV. But I would say this year is not turning out as we expected. And I answered Terrence questions in terms of how much is really split between COVID and RSV, so you can kind of get an understanding there.

是的，兩者都有一點。我們不會對其進行詳細分析，也不會提供有關 RSV 的指導。但我想說，今年的結果並不像我們預期的那樣。我回答了特倫斯的問題，即新冠病毒和呼吸道合胞病毒之間到底有多少區別，所以你可以在那裡有所了解。

But again, we were third to market this year. Some of the contracts were already negotiated. We only are participating in the second half. But I think our hope is that we get access across many of the retail chains. We started to us to get comfortable with us with a second product. So that when we head into 2025, we can get a more fairer market share on RSV.

但我們今年再次進入市場第三。一些合約已經談妥。我們只參加下半場。但我認為我們的希望是能夠進入許多零售連鎖店。我們開始讓我們對第二個產品感到滿意。這樣當我們進入 2025 年時，我們就能在 RSV 上獲得更公平的市佔率。

Eliana Merle, UBS.

埃利安娜梅爾，瑞銀。

This is Elliott Bosco from UBS on for Ellie Merle. Two from us. Can you elaborate on the latest timing you expect for the Phase III CMV study based on how event rates are tracking? And based on just the necessary 12 months of median safety follow-up, from a purely protocol perspective, what is the earliest we could potentially get the interim?

我是瑞銀 (UBS) 的艾利歐特‧博斯科 (Elliott Bosco)，代表艾莉‧梅爾 (Ellie Merle)。我們兩個。您能否根據事件發生率的追蹤情況詳細說明您預期的第三階段 CMV 研究的最新時間？僅基於必要的 12 個月的中位安全性隨訪，從純粹的方案角度來看，我們最早可以得到臨時的結果是多少？

And then second, on international COVID revenues in future years. What do you see is the likelihood of potential deferral again in 2025?

其次，關於未來幾年國際新冠的疫情收入。您認為 2025 年再次延後的可能性有多大？

Great. Thanks for the question. I'll take the first. So first, we have an update on case numbers for CMV. We may have enough at R&D Day, I'm not sure. But we don't have any change to our prior guidance, which is we do think that the interim analysis of efficacy could happen this year. And that would account for also a median safety follow-up from a timing perspective.

偉大的。謝謝你的提問。我就拿第一個吧首先，我們更新了 CMV 病例數。我不確定，我們在研發日可能有足夠的資源。但我們之前的指導沒有任何改變，我們確實認為今年可能會進行中期療效分析。從時間角度來看，這也可以解釋中位安全性後續行動。

And so at this point, no new update, but we continue to stand to believe that the interim analysis for [FCM] the CMV program could happen this year.

因此，目前沒有新的更新，但我們仍然相信 [FCM] CMV 計劃的中期分析可能會在今年進行。

Yeah. And Elliott, on the deferrals, could they happen in 2025? The answer is yes, they can always happen. That said, some of this will push into next year. So -- and if some of those push into the following year, those two would offset we're not expecting that at that point.

是的。埃利奧特（Elliott）關於延期，它們會在 2025 年發生嗎？答案是肯定的，它們總是可能發生。也就是說，其中一些將推遲到明年。因此，如果其中一些推遲到下一年，這兩者將抵消我們當時不期望的影響。

The other thing I'd say is we will come to market with our resilience contracts in the UK, Australia and Canada. That provides us an additional growth in those areas as well as potentially participating in additional public tenders as well. So there's a little bit of risk, but I think we can mitigate it with the deferrals from this year as well as additional resilience contracts.

我要說的另一件事是，我們將在英國、澳洲和加拿大推出我們的彈性合約。這為我們在這些領域提供了額外的成長，並有可能參與更多的公開招標。因此存在一點風險，但我認為我們可以透過今年的延期以及額外的彈性合約來減輕風險。

Gena Wang, Barclays.

王吉娜，巴克萊銀行。

I just have one question regarding the guidance for this year, particularly regarding the COVID revenue in the US. And the since contracting is mostly down and you already also expect similar vaccination way versus the last year. And we know there is mainly only two players. So what could lead to the lower COVID revenue this year from prior $2 billion guidance.

我只有一個關於今年指導的問題，特別是關於美國的新冠疫情收入。自那時起，合約大部分下降，您也已經預期疫苗接種方式與去年類似。我們知道主要只有兩名球員。那麼，什麼可能導致今年的新冠疫情收入較先前的 20 億美元指引下降。

Yeah. Thanks, Gena. So we define competitiveness, both in terms of share and in price. So we're relatively pleased with our market share. There's potentially some price pressure in there.

是的。謝謝，吉娜。因此，我們從份額和價格兩個方面來定義競爭力。所以我們對我們的市佔率比較滿意。那裡可能存在一些價格壓力。

But generally speaking, we think that the US will perform pretty well compared to last year. But we are seeing a bit of a competitive -- a more competitive market this year. After a year where in the US, we had nearly 50% or approximately 50% market share. So we're seeing the pressure, but still confident in the overall performance of the US business.

但總的來說，我們認為與去年相比，美國的表現會相當好。但我們看到今年的市場競爭更加激烈。在美國一年後，我們擁有近 50% 或約 50% 的市佔率。所以我們看到了壓力，但仍然對美國業務的整體表現充滿信心。

Luca Issi, RBC Capital.

盧卡·伊西，加拿大皇家銀行資本。

Maybe, Stephen, quick question on the recent ACIP meeting. If you estimated the debate before that ASIC meeting was whether RSV was going to be either annual or every other year vaccine. However, ACIP clearly chose a meter of them and simply said, this is one and done. So two questions.

史蒂芬，也許可以簡單問一下最近舉行的 ACIP 會議。如果您估計 ASIC 會議之前的爭論是 RSV 是每年一次還是每隔一年接種一次疫苗。然而，ACIP 明確選擇了其中一米，並簡單地說，這就是一個了。那麼兩個問題。

Were you surprised by that decision? And two, how should we think about the market potential for RSV long term in light of the fact and this is maybe one and done vaccine versus obviously COVID and flu our annual vaccines. Any color there much appreciated. And then maybe quick can me walk us through what the latest thinking on the opportunity for bird flu.

您對這個決定感到驚訝嗎？第二，根據事實，我們應該如何考慮 RSV 的長期市場潛力，這可能是一種已經完成的疫苗，而不是我們的年度疫苗，顯然是新冠病毒和流感疫苗。那裡的任何顏色都非常受歡迎。然後我可以快速向我們介紹一下關於禽流感機會的最新想法。

Great. Thank you for both questions. So obviously, first and foremost, our focus at the ACIP meeting was we're quite pleased with the parity recommendation.

偉大的。謝謝你的兩個問題。顯然，首先也是最重要的是，我們在 ACIP 會議上的重點是我們對平價建議非常滿意。

And I think we're all pleased with the clear recommendation for those over the age of 75 and those with higher risk from RP that they really should get back to noon. As it's only a year old as a market, the most important thing we can do is cover the large number of people who are now recommended 40 million-plus who are not vaccinated and that's a quite large increase in the number of folks who we hope to cover soon.

我認為我們都對針對 75 歲以上人群和 RP 風險較高人群的明確建議感到滿意，他們確實應該回到中午。由於這個市場只有一年的歷史，我們能做的最重要的事情就是覆蓋目前推薦的 4000 萬以上未接種疫苗的大量人群，這是我們希望接種疫苗的人數的大幅增長很快就會覆蓋。

Now on the question to your specific question of revaccination. I think it's also important to say that we are -- the ACIP is really just looking at one year of real-world data. And all three of the vaccines, but including mRESVIA, show significant second season protection although it does decrease.

現在回答您關於重新接種疫苗的具體問題。我認為同樣重要的是我們——ACIP 實際上只是專注於一年的真實數據。所有三種疫苗（包括 mRESVIA）都顯示出顯著的第二季保護作用，儘管它確實有所下降。

And so there is a decline from season one into season two from a clinical trial perspective, but there's still protection there in that year, too. And so while you're only one year into that public experience, public health experience, I think ACIP took a prudent choice and said there's still a benefit and maybe the focus should be on increasing vaccination coverage rates for those who are currently unprotected because there clearly is some benefit, even still out that second year.

因此，從臨床試驗的角度來看，從第一季到第二季有所下降，但那一年仍然存在保護。因此，雖然你只有一年的公共經驗、公共衛生經驗，但我認為ACIP 採取了謹慎的選擇，並表示仍然有好處，也許重點應該放在提高目前未受保護的人的疫苗接種覆蓋率上，因為顯然這是有一些好處的，即使在第二年仍然如此。

I think if you fast forward a year, and this would be my perception. But if you fast forward a year, if you look at the rates of waning for the other two vaccines and ours, there's clearly a decline from year one to two and from your two to three and the pace of that decline suggests that by year three, there really won't be much protection for those people who have received vaccines in the first year. I think that's when you probably need to start asking a question of do we continue to leave those people unprotected or boost them again.

我想如果快進一年，這將是我的看法。但如果你快轉一年，如果你看看其他兩種疫苗和我們的疫苗的下降速度，你會發現從第一年到第二年、從第二年到第三年明顯下降，下降的速度表明，到第三年，對於第一年接種疫苗的人來說，確實不會有太大的保護。我認為那時你可能需要開始問一個問題：我們是繼續讓這些人不受保護，還是再次加強他們的能力。

Now from a scientific perspective, you asked my view, you will be infected with RSV doesn't almost 20 times in your life. You will repeatedly get ill. In fact, many people who are at risk of severe complications over the age of 75 or other lines with medical comorbidity, they see RSV before. It's the waning protection from that infection that ultimately is the reason why you need a vaccine.

現在從科學的角度來看，你問我的看法，你一生中感染RSV的次數不會差不多20次。你會反覆生病。事實上，許多 75 歲以上有嚴重併發症風險的人或患有其他疾病的人以前都曾感染過 RSV。最終，您需要疫苗的原因是對這種感染的保護作用減弱。

And because you get infected multiple times by that virus over their life, even if you've seen it before, you probably will benefit from a booster in the future. And so we continue to believe that as the public health story evolves, that recommending bodies in CDC and ACIP will look at the waning efficacy, the potential to boost people again and hopefully provide additional public benefit. And that eventually, there will be recommendations for revaccination for those who are at highest risk of RSV.

而且因為您一生中會多次感染該病毒，即使您以前見過這種病毒，您將來也可能會從加強劑中受益。因此，我們仍然相信，隨著公共衛生故事的發展，CDC 和 ACIP 的推薦機構將考慮逐漸減弱的功效、再次提振人們的潛力，並希望提供額外的公共利益。最終，我們將建議那些感染 RSV 風險最高的人重新接種疫苗。

But it is not our choice at all, because we are providing that data to, obviously, the regulator but principally to groups like CDC now, and then they will determine the right moment, if ever, to recommend that revaccination in the United States.

但這根本不是我們的選擇，因為顯然我們正在向監管機構提供這些數據，但現在主要是向疾管中心等組織提供，然後他們將確定建議在美國重新接種疫苗的合適時機（如果有的話） 。

As it relates to bird flu, we continue to follow that very quickly, that drifted a little bit out of the news more recently. I think that's a good thing. But the most important news for us has been in the quarter, we excluded an agreement with BARDA to advance into Phase III with our pandemic bird flu vaccine, which we'll provide updates on as we move forward in the months and the year ahead.

由於它與禽流感有關，我們繼續快速跟踪，最近有點脫離了新聞。我認為這是一件好事。但對我們來說最重要的消息是在本季度，我們排除了與BARDA 達成的協議，以將我們的大流行性禽流感疫苗推進到第三階段，我們將在未來幾個月和一年的進展中提供最新進展。

But we will be sure to be partnering with public health entities across the world, including the United States government, specifically are grateful for working with BARDA again, in the event that Burcu does emerge as a pandemic epidemic through this country.

但我們一定會與包括美國政府在內的世界各地的公共衛生實體合作，特別是在布爾庫病毒確實在該國成為大流行病的情況下再次與 BARDA 合作表示感謝。

Alexandra Hamman, BofA.

亞歷山德拉哈曼，美國銀行。

So how do results for [BS522] in collaboration for [KEYTRUDA] as results provide positive proof of concept for the ability of mRNA and liponanoparticles to be artilized and cross the newer in the lung. Can you walk us through additional indications you may be interested in? And should we expect you to develop these indications in partnership with Vertex?

那麼，[BS522] 的結果如何與 [KEYTRUDA] 合作，因為這些結果為 mRNA 和脂奈米顆粒在肺部進行加工和穿過新物質的能力提供了積極的概念證明。您能否向我們介紹您可能感興趣的其他適應症？我們是否應該期望您與 Vertex 合作開發這些適應症？

Thanks for the question. So -- we have -- as you highlighted, there was a large number of pulmonary diseases for which respiratory delivery could be quite impactful. We have not provided any updates on the preclinical programs that we've moved into development.

謝謝你的提問。因此，正如您所強調的，呼吸輸送可能對許多肺部疾病產生相當大的影響。我們尚未提供有關我們已進入開發的臨床前項目的任何更新。

And so I would describe those activities right now as still research and discovery phase and therefore not something for competitive reasons and precise agreement that we'll talk about. They're in the earlier stages.

因此，我現在將這些活動描述為仍處於研究和發現階段，因此不是出於競爭原因和我們將討論的精確協議。他們正處於早期階段。

As it relates to whether we would partner with Vertex, we would, of course, always be welcome -- we welcome partnering with Vertex given their expertise. But the partnership we have right now, the deal we have with them is limited to the cystic fibrosis program at this point.

由於這關係到我們是否會與 Vertex 合作，我們當然會永遠受到歡迎 - 鑑於 Vertex 的專業知識，我們歡迎與 Vertex 合作。但我們現在的合作關係，我們與他們達成的協議目前僅限於囊性纖維化計畫。

Edward Tenthoff, Piper Sandler.

愛德華·騰索夫，派珀·桑德勒。

Most of my questions have been answered. I appreciate all the detail. I wanted to ask a little bit about the orphan disease programs. So maybe you can provide a little bit of color on what the regulatory path might look like in MMA and PA.

我的大部分問題都得到了解答。我很欣賞所有的細節。我想詢問一些有關孤兒疾病計劃的情況。因此，也許您可以提供一些有關 MMA 和 PA 監管路徑的資訊。

Thanks, Ed. So they are somewhat different and they are early stages of those regulatory conversations. So we just received the FDA Start designation.

謝謝，艾德。所以它們有些不同，而且它們還處於監管對話的早期階段。所以我們剛剛獲得了 FDA 的 Start 指定。

But if you look at the data that we shared last R&D Day, and we'll obviously provide updates on this going forward, one of the clearer pictures that emerged was that in MMA, we are seeing good movement of a biomarker, metamolonic acid, that's pathognomonic for the disease. And so you can imagine one of the challenges very quickly when you have a good biomarker.

但如果你看一下我們上次研發日分享的數據，我們顯然會提供有關未來的更新，出現的更清晰的畫面之一是在 MMA 中，我們看到生物標誌物偏羥二酸的良好變化，這是這種疾病的特徵。因此，當您擁有良好的生物標記時，您可以很快想像其中的挑戰之一。

It's how do you validate that biomarker and show that moving that biomarker is reasonably likely to predict and that's a scientific question we will work on and ultimately engage with regulators, including FDA on as a key step for moving forward. We are evaluating in the clinical trial folks and their movement in their biomarker from baseline. So it's a clear study to run.

問題在於如何驗證該生物標誌物，並證明移動該生物標誌物是有可能預測的，這是我們將致力於解決的科學問題，並最終與包括FDA 在內的監管機構合作，作為前進的關鍵一步。我們正在臨床試驗中評估人們及其生物標記相對於基線的變化。所以這是一項明確的研究。

In the case of propionic acidemia, there is not as clear a biomarker in the field because of the structure of that particular part of the metabolic pathway.

就丙酸血症而言，由於代謝途徑特定部分的結構，該領域還沒有明確的生物標記。

And so there, we've been following events. And as you know, we previously shared in a single-arm study, the pre and post-treatment rates of metabolic compensations. We have seen a favorable trend in that. We're actually quite excited about that.

因此，我們一直在關注事件。如您所知，我們之前在一項單臂研究中分享了治療前和治療後的代謝補償率。我們已經看到了這方面的有利趨勢。我們實際上對此感到非常興奮。

That takes a little more time than biomarker, but we obviously have been working on that a little bit longer. And so we'll be engaging with regulators on that single-arm approach and understanding the difference between internal controls or other control groups to evaluate that.

這比生物標記物需要更多的時間，但我們顯然在這方面的工作時間更長一些。因此，我們將與監管機構就這種單臂方法進行合作，並了解內部控製或其他控制組之間的差異來評估這一點。

In any event, you may end up with a randomized study, you may be able to use a single-arm study. And in the case of you may or may not be able to use the biomarker. So those are the kinds of conversations that we're having. But as I said, they're early days. The FDA start discussion on M&A just started. And so we'll provide updates as we have more clarity on those times.

無論如何，您最終可能會進行隨機研究，您也許可以使用單臂研究。在這種情況下，您可能能夠也可能無法使用生物標記。這就是我們正在進行的對話。但正如我所說，現在還處於早期階段。 FDA 對併購的討論才剛開始。因此，當我們對這些時間有更清晰的了解時，我們將提供更新。

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

For RSV, I'm curious your take on Pfizer's comment that customers want to carry an RSV vaccine that can address both the maternal and the older adult population.

對於 RSV，我很好奇您如何看待輝瑞公司的評論，即客戶希望攜帶能夠同時針對孕產婦和老年人群的 RSV 疫苗。

And then for INT I saw on the near-term milestone slide. But to clarify, what's your latest projection on when you expect to complete enrollment of the Phase III adjuvant melanoma trial? And what's the latest you can share on manufacturing progress for that product? Are there any updates to share on how that's going?

然後對於 INT，我看到了近期里程碑幻燈片。但需要澄清的是，您對何時完成 III 期輔助黑色素瘤試驗的最新預測是什麼？您可以分享該產品的最新製造進度嗎？是否有任何最新進展可以分享？

(multiple speakers)

（多個發言者）

Obviously, the majority of the recommended population in this country continues to be the older adults. I wouldn't comment on Pfizer's competitive positioning on their quarterly call, except to say that in the retail channel, overwhelmingly and in many physician offices, overwhelmingly, the focus is on protecting older Americans. What's happening with a younger population, maternal population is obviously smaller in terms of an overall market opportunity.

顯然，這個國家的大多數推薦人群仍然是老年人。我不會評論輝瑞在季度電話會議上的競爭定位，只說在零售通路和許多醫生辦公室，絕大多數的重點是保護美國老年人。就整體市場機會而言，隨著年輕人口的增加，孕產婦人口顯然更小。

We do recognize the need to try and provide the broadest potential label and as we previously updated, we are pleased that we've conducted our Phase III study in 18 to 59-year-old high-risk population, and we intend to file that this year with the goal of expanding that label for those who are at high risk for medical and may benefit from an RSV vaccine even if they are younger.

我們確實認識到需要嘗試提供最廣泛的潛在標籤，正如我們之前更新的那樣，我們很高興我們在 18 至 59 歲的高風險人群中進行了 III 期研究，我們打算將其歸檔今年的目標是將這個標籤擴大到那些醫療風險高、即使年齡較小也可能受益於RSV 疫苗的人。

And so I would say we agree that a broad label is valuable, but I think it's important to cover as many people as possible, and that's where we're excited by moving forward with our 18 to 59-year-old filing.

所以我想說，我們同意廣泛的標籤是有價值的，但我認為覆蓋盡可能多的人很重要，這就是我們對推進 18 至 59 歲申請感到興奮的地方。

On the question of INT, we're -- we have not, with our partner, updated yet on where we are in enrollment. Obviously, as we had said at ASCO, and there was quite some coverage of, it's been brisk. We are pleased, very pleased with the pace of enrollment. And we do expect that to conclude quickly, but we have not yet provided any updates and we'll obviously do so at the appropriate time with our partner, Merck.

關於 INT 的問題，我們尚未與我們的合作夥伴一起更新我們的註冊情況。顯然，正如我們在 ASCO 上所說的那樣，並且有相當多的報道，它一直很活躍。我們對招生速度感到非常滿意。我們確實希望此事能盡快結束，但我們尚未提供任何更新，顯然我們會在適當的時候與我們的合作夥伴默克公司一起提供。

As it relates to manufacturing, we actually have made great progress there of establishing our Marlboro facility as well as demonstrating through the clinical trial, our ability to manufacture at high volume, frankly, commercially relevant volumes.

就製造而言，我們實際上在建立萬寶路工廠以及透過臨床試驗證明我們大批量生產的能力方面取得了巨大進展，坦率地說，具有商業相關的產量。

And so we're we feel like we're in a good place in terms of the manufacturing trajectory. It's still a few months of work to go this year to get to where we want to be, but we're starting to feel quite optimistic that the manufacturing will be online as and when we hope.

因此，我們感覺我們在製造軌跡方面處於有利位置。今年我們還需要幾個月的時間才能達到我們想要的目標，但我們開始對製造將在我們希望的時間上線感到非常樂觀。

[Evan Wang], Guggenheim Securities.

[Evan Wang]，古根漢證券。

A few for me. Just first, just given all the comments on the higher competitive environment, how are you thinking longer term about the outlook for RSV and COVID versus some of the assets you made earlier in the year and historically, just given some of the pricing and market share dynamics there.

給我幾個。首先，考慮到對競爭更加激烈的環境的所有評論，考慮到一些定價和市場份額，與您今年早些時候和歷史上製作的一些資產相比，您如何看待 RSV 和 COVID 的長期前景那裡的動態。

Second, with COVID in the EU tender, what's your level of confidence in the EU being a meaningful contributor in -- and what changes between now and then? Does having the combo or potentially having a combo add to competitiveness there?

其次，隨著新冠疫情出現在歐盟招標中，您對歐盟作為有意義的貢獻者的信心程度如何，以及從現在到那時發生了什麼變化？擁有組合或可能擁有組合會增加那裡的競爭力嗎？

And lastly, I saw that you guys purchased a PRV, is that for use on the combo or the standalone flu -- and are you comfortable in getting ahead of a potential June recommendation next year?

最後，我看到你們購買了 PRV，它是用於組合還是獨立流感 - 您是否願意提前於明年 6 月的潛在推薦？

Thanks. This is Stéphane. So on the higher competitive environment on COVID-19. What we believe is on ISV as customers are going to experience the PFS product, and that will have the ability to really have kind of flu season to be able to train and to get the products through the channel that will help a lot. So we anticipate in '25 to a better share than in '24 for the US. So we're going to be launching all the outside US markets in '25, but of course, will not have sales in '24, that's going to be important for growth.

謝謝。這是史蒂芬。因此，在 COVID-19 的競爭環境更加激烈的情況下。我們相信 ISV 的客戶將體驗 PFS 產品，並且將有能力在真正的流感季節進行培訓並透過管道獲取產品，這將有很大幫助。因此，我們預計美國 25 年的份額將高於 24 年。因此，我們將在 25 年推出所有美國以外市場，但當然，不會在 24 年進行銷售，這對成長非常重要。

In COVID, we believe the portfolio in terms of next-gen COVID and flu plus COVID. These are important to drivers to kind of reset the expectation moving forward and the market dynamics.

在新冠病毒方面，我們相信下一代新冠病毒和流感加新冠病毒的投資組合。這些對駕駛者來說很重要，可以重新設定未來的預期和市場動態。

In terms of the EU, the current contract between Pfizer and EU end in 2026. So we think 2025 and 2026 are still going to be low. Some countries have actually used a lot of air vaccines. And so we could see some countries in '25 and more '26 needing COVID vaccine and then wanting to diversify their supply base.

就歐盟而言，輝瑞與歐盟目前的合約將於 2026 年結束。一些國家實際上已經使用了大量的空氣疫苗。因此，我們可能會看到 25 年和 26 年以後的一些國家需要新冠疫苗，然後希望實現供應基礎多元化。

We our vaccine as well given its performance. First, as you mentioned, the combo is something that we have been discussing quite a lot with governments in Europe basically the value of a combo given its strong performance as we've shared to be an important tool for public health in terms of compliance in a world where governments are worried about people getting their flu shots and the COVID shots and the RSV shots, there just a lot of shots and nobody likes needle, so we like to go to the doctors and to the pharmacies.

鑑於其性能，我們也開發了疫苗。首先，正如您所提到的，我們一直在與歐洲各國政府就該組合進行大量討論，鑑於其強勁的性能，我們已經分享了該組合在合規性方面成為公共衛生的重要工具。上，政府擔心人們接種流感疫苗、新冠疫苗和呼吸道合胞病毒疫苗，注射次數很多，但沒有人喜歡打針，所以我們喜歡去看醫生和去藥局。

And so the combo is something that the customers are really valuing. And so that could be another opportunity in countries when this product is available to go back into growing Europe. The key priority for us in Europe now for 2025 is really launching RSV and growing the business around RSV until we see the flu model or a flu plus COVID launch.

因此，組合是客戶真正重視的東西。因此，當該產品可以重返不斷發展的歐洲時，這可能是各國的另一個機會。現在，我們在歐洲 2025 年的首要任務是真正推出 RSV 並圍繞 RSV 發展業務，直到我們看到流感模型或流感加新冠病毒的推出。

Tyler Van Buren, TD Securities.

泰勒·範布倫，道明證券。

This is [Greg] on behalf of Tyler from TD Securities. So I understand your thoughts on the magnitude of the RSV market, (technical difficulty) being small relative to last year during the earnings, so you agree? And what is your latest thinking on the overall size of the RSV market in elderly patients versus the prior, or they built in expectations?

我是道明證券 (TD Securities) 泰勒 (Tyler) 的代表 [Greg]。所以我理解您對 RSV 市場規模的看法，（技術難度）相對於去年財報期間較小，所以您同意嗎？與之前相比，您對老年患者 RSV 市場整體規模的最新看法是什麼，或者他們的預期是什麼？

So you broke up a little bit during your question. I think the -- we caught the tail end of your question, which is what is the size of the RSV market relative to what we thought previously.

所以你們在提問的時候有點分手了。我認為——我們抓住了你問題的尾部，即 RSV 市場相對於我們之前的想法有多大。

Yes. Thank you. So just to reiterate quickly, I believe that GSK discussed RSV market being smaller business relative to last year's earnings call (technical difficulty) what was your latest thinking on the overall size versus the prior $6 billion to $8 billion (technical difficulty)

是的。謝謝。因此，快速重申一下，我相信葛蘭素史克討論了RSV 市場相對於去年的財報電話會議而言規模較小的業務（技術難度），與之前的60 億至80 億美元（技術難度）相比，您對整體規模的最新想法是什麼

Yeah. So let me try to take a stab at it. As Stephen said, in the long term, we believe that as real all evidence data is gathered by public health leaders, that they will most probably be a need for boosting. The current organization is what it is. But as Stephen said, we believe this will potentially evolve over time.

是的。所以讓我嘗試一下。正如史蒂芬所說，從長遠來看，我們相信，由於公共衛生領導人收集了所有真實的證據數據，因此它們很可能需要加強。目前的組織就是這樣。但正如史蒂芬所說，我們相信這可能會隨著時間的推移而發展。

For this year, I think what is interesting is on paper, it seems that it could be a smaller market. The thing that's going be interesting to see how it plays out in terms of market size and number of doses in arms is the guidelines are much more clear than last year. And as you know, sometimes in vaccinations, you get a better reaction from the doctors and pharmacies and consumer with clear guidelines versus not as guidelines with a larger population potential.

今年，我認為有趣的是在紙上，它似乎可能是一個較小的市場。有趣的是，看看它在市場規模和武器劑量方面的表現如何，指導方針比去年更加明確。如你所知，有時在疫苗接種過程中，醫生、藥局和消費者如果有明確的指導方針，會得到更好的反應，而不是有更大人口潛力的指導方針。

So because of those two factors, it's going to be interesting to see how the season plays out.

因此，由於這兩個因素，看看這個賽季的表現將會很有趣。

I would just comment on the current year market size as well. I think we've talked about what we believe the patient population is, which is still sizable. And we believe that the market will still be overall sizable this year and similar to last year, a little bit more.

我也只想評論一下今年的市場規模。我想我們已經討論了我們所認為的患者群體，這個群體仍然相當大。我們認為今年的市場整體規模仍然很大，與去年類似，但會更大一些。

And I think there are other factors at play with those comments. There was a lot of inventory that was -- or a lot of sales that happened in the prior year that customers may be sitting on some of that inventory. So from a revenue perspective, that might be different. But from a vaccination rate perspective, we believe that it will still be similar, if not a little bit bigger this year.

我認為這些評論還有其他因素在起作用。有大量的庫存，或前一年發生的大量銷售，客戶可能持有其中的一些庫存。因此，從收入角度來看，情況可能會有所不同。但從疫苗接種率的角度來看，我們認為今年的疫苗接種率即使不是更高一點，也將與此類似。

Cory Kasimov, Evercore.

科里·卡西莫夫，Evercore。

This is [Adi] on for Cory. Another question on -- has the recent summer coveted caused any concern for fall vaccination as the infected population is usually recommended not to get vaccinated for six months post infection? And is the base case for the US COVID revenue is similar vaccination as last year which I think our CDC tracking was 22.5% overall population, 40% for 65 and above.

這是科里的[阿迪]。另一個問題是——最近令人垂涎的夏季是否引起了對秋季疫苗接種的擔憂，因為通常建議感染人群在感染後六個月內不要接種疫苗？美國新冠疫苗接種收入的基本情況與去年類似，我認為我們的 CDC 追蹤數據是整體人口的 22.5%，其中 65 歲及以上人口占 40%。

Yeah, I'll take it. So first, the question on the summer wave in the epidemiology. We've seen this multiple years in a row now. And so in some ways, there is move in certain geographies towards a little bit of a summer wave.

是的，我會接受的。首先，關於流行病學中的夏季浪潮的問題。我們已經連續多年看到這種情況。因此，在某些方面，某些地區正在走向夏季浪潮。

It just highlights the fact that this virus is incredibly effective at spreading, incredibly effective at creating disease even for folks many years after vaccination and other protection and why we need to protect people for the winter season because the whatever we see in the summer, you see a dramatically higher rate in the November through February time. And so that's really where we're trying to protect people for.

它只是強調了這樣一個事實，即這種病毒的傳播能力非常有效，甚至對於接種疫苗和其他保護措施多年後的人來說，它在製造疾病方面也非常有效，以及為什麼我們需要在冬季保護人們，因為無論我們在夏天看到什麼， 11 月至 2 月期間的比率顯著增加。這就是我們努力保護人們的真正目的。

But in terms of business, summer wave impact, the small summer wave impact the view of the fall wave, it really doesn't change year-over-year that perspective. And that's why we're confident the vaccination coverage rate will still be there. And as Jamey said, we see them the same. We hope to do better, but we see them minimally as similar to last year in the United States.

但就業務而言，夏季浪潮的影響，夏季浪潮的小影響對秋季浪潮的看法，與去年同期相比，這一觀點確實沒有改變。這就是為什麼我們有信心疫苗接種覆蓋率仍然存在。正如傑米所說，我們對他們的看法是一樣的。我們希望做得更好，但我們認為它們與去年美國的情況基本上相似。

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

謝謝。女士們先生們，今天電話會議的問答部分到此結束。我想請 Stéphane Bancel 做結束語。

Well, thank you, everybody, for joining us, and we look forward to speaking to many of you in the coming days and weeks and if not seeing you for R&D day in September 2. Have a great day. Bye.

好的，謝謝大家加入我們，我們期待在接下來的幾天和幾週內與你們中的許多人交談，如果在 9 月 2 日的研發日沒有見到你們的話。再見。

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。