莫德納 (MRNA) 2023 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to Moderna's Second Quarter 2023 Conference Call. (Operator Instructions) Please be advised today's conference is being recorded.

美好的一天，感謝您的支持。歡迎參加 Moderna 2023 年第二季度電話會議。 （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 your speaker today, Lavina Talukdar, Head of Investor Relations. Please go ahead.

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

Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's Second Quarter 2023 financial results and business updates. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website.

謝謝你，凱文。大家早上好，感謝您參加今天的電話會議，討論 Moderna 2023 年第二季度的財務業績和業務更新。您可以訪問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; Arpa Garay, our Chief Commercial Officer; and Jamey Mock, our Chief Financial Officer.

我們的首席執行官 Stéphane Bancel 出席了今天的電話會議；斯蒂芬·霍格，我們的總裁； Arpa Garay，我們的首席商務官；以及我們的首席財務官 Jamey Mock。

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

在我們開始之前，請注意，本次電話會議將包括根據1995 年《私人證券訴訟改革法案》的安全港條款做出的前瞻性陳述。請參閱隨附演示文稿的幻燈片2 以及我們向SEC 提交的文件，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存在重大差異。

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

這樣，我會將電話轉給 Stéphane。

Thank you, Lavina. Good morning, or good afternoon. Today, I will start with a business review of our second quarter. Stephen will then review our clinical programs before Arpa gives an update on our commercial progress and plans. Jamey will present our financial results, and I will come back to share some final thoughts.

謝謝你，拉維娜。早上好，或者下午好。今天，我將從第二季度的業務回顧開始。然後，在 Arpa 更新我們的商業進展和計劃之前，斯蒂芬將審查我們的臨床項目。傑米將介紹我們的財務業績，我將回來分享一些最終的想法。

In Q2, we reported revenues of approximately $300 million, reflecting the seasonal nature of endemic respiratory vaccines. Given our investments in our 4 infectious disease vaccine programs, which are in Phase III and our oncology program also in Phase III, this off-season quarter sales resulted in a GAAP net loss of $1.4 billion, GAAP diluted loss per share of $3.62. We ended the quarter with a cash and investment balance of $14.6 billion.

第二季度，我們報告收入約為 3 億美元，反映了地方性呼吸道疫苗的季節性。鑑於我們對 4 個傳染病疫苗項目（處於第三階段）和腫瘤學項目（也處於第三階段）的投資，這個淡季季度銷售導致 GAAP 淨虧損 14 億美元，GAAP 攤薄後每股虧損 3.62 美元。本季度結束時，我們的現金和投資餘額為 146 億美元。

We continue to execute on our capital allocation strategy, prioritizing organic growth of our platform with investments in our business. In Q2, we invested $1.1 billion in R&D, continuing investments in late-stage clinical programs and progressing our pipeline. SG&A costs were approximately $300 million. Capital investments were approximately $200 million.

我們繼續執行我們的資本配置策略，優先考慮我們平台的有機增長和對我們業務的投資。第二季度，我們在研發上投資了 11 億美元，繼續投資後期臨床項目並推進我們的產品線。 SG&A 成本約為 3 億美元。資本投資約為2億美元。

Year-to-date, our external investments were all strategic collaborations with the exception of OriCiro in Japan, which was an acquisition. OriCiro was renamed Moderna Enzymatics and is being integrated into Moderna manufacturing process development organization.

今年以來，我們的對外投資除了日本的OriCiro是收購之外，都是戰略合作。 OriCiro 更名為 Moderna Enzymatics，並正在整合到 Moderna 製造工藝開發組織中。

From a capital return perspective, we repurchased 4.4 million shares in Q2 for a total of $628 million.

從資本回報的角度來看，我們在第二季度回購了 440 萬股股票，總計 6.28 億美元。

Now turning to commercial and late-stage clinical updates in the quarter. With the submission of our XBB updated COVID-19 vaccine applications to regulators globally, we are now awaiting approval to start fall of 2023 sales. As you will hear from Arpa shortly, we're updating for COVID-19 sales expectation for 2023 to a range between $6 billion and $8 billion. This range reflects additional contracts in the U.S. commercial market and other countries. This range is wide given the uncertainty on the U.S. vaccination rate.

現在轉向本季度的商業和後期臨床更新。隨著我們向全球監管機構提交 XBB 更新的 COVID-19 疫苗申請，我們現在正在等待批准，以便於 2023 年秋季開始銷售。正如您很快就會從 Arpa 那裡聽到的那樣，我們正在將 2023 年的 COVID-19 銷售預期更新為 60 億至 80 億美元之間。這一範圍反映了美國商業市場和其他國家的額外合同。考慮到美國疫苗接種率的不確定性，這個範圍很寬。

Our commercial team is also preparing for the 2024 launch of RSV, our next respiratory commercial product. Regulatory applications have been submitted in major markets around the world. We've also started to manufacture mRNA-1345 in preparation for the launch. As a reminder, at launch, this product will be in a pre-filled syringe presentation, which combined with a strong efficacy profile, we position very well on product to health care professionals.

我們的商業團隊還在為 2024 年推出我們的下一個呼吸商業產品 RSV 做準備。全球主要市場均已提交監管申請。我們還開始生產 mRNA-1345，為上市做準備。提醒一下，在推出時，該產品將以預裝注射器的形式展示，結合強大的功效特徵，我們對醫療保健專業人員的產品定位非常好。

In oncology, for mRNA-4157, or Individualized Neoantigen Therapy or INT, we are continuing to scale up manufacturing to support clinical development and commercial markets. We are very pleased to report our Phase III study in adjuvant melanoma has begun enrolling patients in July.

在腫瘤學領域，對於 mRNA-4157 或個體化新抗原治療或 INT，我們正在繼續擴大生產規模以支持臨床開發和商業市場。我們非常高興地報告我們的輔助黑色素瘤 III 期研究已於 7 月開始招募患者。

We will plan, on Slide 6, our updated company profile. The breadth of our late-stage pipeline means we could see multiple launches in '24, '25 and '26.

我們將在幻燈片 6 上規劃更新後的公司簡介。我們後期研發管線的廣度意味著我們可以在 24 年、25 年和 26 年看到多次發布。

Turning now to Slide 7. I am proud to share that Moderna has been named as one of the world's most innovative companies in 2023 for pioneering AI-driven innovation by the Boston Consulting Group. As many of you know, AI has been part of the foundation of Moderna's research and development programs for several years. We have built our own AI models for protein and mRNA engineering, data analysis, regulatory interactions and many more other use cases.

現在轉向幻燈片 7。我很自豪地告訴大家，Moderna 因其在人工智能驅動創新方面的先驅地位而被波士頓諮詢集團評為 2023 年全球最具創新力的公司之一。眾所周知，多年來，人工智能一直是 Moderna 研發項目基礎的一部分。我們已經為蛋白質和 mRNA 工程、數據分析、監管相互作用和許多其他用例構建了自己的人工智能模型。

As we continue to be an AI leader in biopharma, one of our key modular mindset is that we digitize everything possible as we recognize that this will be central to the impact we have with AI. As of 2023, AI training is required for all Moderna's team members and will facilitate this training at the corporate level through our AI Academy. We have challenged everyone across all of our business functions at Moderna to incorporate AI into their everyday's workflow.

隨著我們繼續成為生物製藥領域的人工智能領導者，我們的關鍵模塊化思維之一是我們將一切可能的數字化，因為我們認識到這將是我們對人工智能產生影響的核心。自 2023 年起，Moderna 的所有團隊成員都需要接受人工智能培訓，並將通過我們的人工智能學院在企業層面促進這種培訓。我們向 Moderna 所有業務部門的每個人提出了挑戰，要求他們將人工智能融入到他們的日常工作流程中。

I'm happy to share our AI implementation is accelerating throughout Moderna. Our secure large language model is called mChat. As you can see on the graph, our mChat usage has grown rapidly amongst our employees since its introduction on May 18. Around 50% of our employees use it already only 60 days after launch.

我很高興與大家分享，我們的人工智能實施正在整個 Moderna 中加速。我們的安全大語言模型稱為 mChat。正如您在圖表中看到的，自 5 月 18 日推出以來，我們的 mChat 使用率在我們的員工中迅速增長。在推出後僅 60 天，我們就有大約 50% 的員工在使用它。

With that, I will now toss to Stephen for an update on development programs.

現在，我將向斯蒂芬詢問開發計劃的最新情況。

Thank you, Stéphane. Good morning or good afternoon, everyone. Today, I'll review the progress of our key clinical programs in Moderna, and I'll start with our respiratory vaccines.

謝謝你，斯特凡。大家早上好或者下午好。今天，我將回顧我們在 Moderna 的關鍵臨床項目的進展，我將從我們的呼吸道疫苗開始。

On the left-hand side of the slide, we have our commercial and late-stage clinical pipeline program against 3 important respiratory viruses, COVID-19, flu and RSV. I'll share some updates on these programs in a moment. Our next-generation programs have made substantial progress over the first half of this year, including mRNA-1283, which is enrolling participants in a Phase III study and our next-generation influenza vaccines, which are both in Phase II. We currently have 6 combination vaccine programs addressing adult and pediatric populations. Our combination vaccines are designed to address the largest health care burdens caused by respiratory infections while providing multiple advantages such as increasing compliance and reducing administration costs.

在幻燈片的左側，我們有針對 3 種重要呼吸道病毒（COVID-19、流感和 RSV）的商業和後期臨床管道計劃。我稍後將分享這些程序的一些更新。我們的下一代項目在今年上半年取得了實質性進展，包括 mRNA-1283（正在招募 III 期研究參與者）和我們的下一代流感疫苗（均處於 II 期研究）。我們目前有 6 個針對成人和兒童人群的聯合疫苗項目。我們的組合疫苗旨在解決呼吸道感染造成的最大醫療保健負擔，同時提供多種優勢，例如提高依從性和降低管理成本。

Turning to our COVID program. We have submitted our applications for approval and authorization of mRNA-1273.815, our updated monovalent COVID-19 vaccine targeting the XBB.1.5 variant. Recall that the June VRBPAC meeting, the committee recommended an XBB-targeted monovalent vaccine with a preference for the XBB.1.5 strain. This recommendation was adopted by the FDA and is in concordance with the EMA and WHO guidance. In the U.S., the CDC ACIP is expected to publish recommendations and guidelines for the use of updated COVID-19 vaccines following approval and authorization this fall.

轉向我們的新冠肺炎計劃。我們已提交 mRNA-1273.815 的批准和授權申請，這是我們針對 XBB.1.5 變體的更新單價 COVID-19 疫苗。回想一下 6 月的 VRBPAC 會議，委員會推薦了一種針對 XBB 的單價疫苗，並優先考慮 XBB.1.5 毒株。該建議已被 FDA 採納，並且與 EMA 和 WHO 指南一致。在美國，CDC ACIP 預計將在今年秋季獲得批准和授權後發布有關使用更新的 COVID-19 疫苗的建議和指南。

On Slide 11 are the clinical data our team presented during the June VRBPAC meeting. Data from a subset of our Phase II/III study with mRNA-1273.815 demonstrated potent neutralization against XBB.1.5 and other variants of the XBB lineage. We're proud that Moderna was the only company that presented clinical data with an XBB.1.5 candidate in advance of the season, which we believe may help uptake of this important vaccine.

第 11 張幻燈片是我們的團隊在 6 月 VRBPAC 會議期間展示的臨床數據。我們的 mRNA-1273.815 II/III 期研究的一個子集的數據證明了對 XBB.1.5 和 XBB 譜系的其他變體的有效中和作用。我們感到自豪的是，Moderna 是唯一一家在本季之前提供 XBB.1.5 候選疫苗臨床數據的公司，我們相信這可能有助於這種重要疫苗的採用。

Moving to RSV. As Stéphane mentioned earlier, we are pleased to be on track for regulatory approvals in 2024. Earlier this month, we announced a rolling submission to the FDA, and we plan to use a priority voucher to accelerate that review. We also filed additional regulatory applications in Europe, Switzerland, Australia and the U.K. We're incredibly encouraged by the profile of mRNA-1345 and look forward to the expected commercial launch next year.

轉向 RSV。正如 Stéphane 之前提到的，我們很高興能夠在 2024 年獲得監管部門的批准。本月早些時候，我們宣布向 FDA 滾動提交申請，併計劃使用優先券來加速審查。我們還在歐洲、瑞士、澳大利亞和英國提交了更多監管申請。我們對 mRNA-1345 的概況感到非常鼓舞，並期待明年的商業推出。

Next, on the seasonal influenza program. I'm pleased to announce that our P303 study is fully enrolled, and we look forward to sharing an update this quarter. P303 is testing an update to mRNA-1010 that is designed to increase the HAI neutralizing titers against the B antigens. This is a safety and immunogenicity Phase III study that we believe will support accelerated approval of the updated mRNA-1010 candidate.

接下來，關於季節性流感計劃。我很高興地宣布我們的 P303 研究已全部入組，我們期待在本季度分享最新情況。 P303 正在測試 mRNA-1010 的更新，旨在提高針對 B 抗原的 HAI 中和滴度。這是一項安全性和免疫原性的 III 期研究，我們相信它將支持加速批准更新的 mRNA-1010 候選藥物。

Now turning to our latent vaccines on Slide 14. Our Phase III CMV vaccine study in women of child-bearing age is ongoing and I'm pleased to share that the trial has enrolled more than 80% of participants. We look forward to full enrollment of that study soon.

現在轉向幻燈片 14 上的潛在疫苗。我們針對育齡婦女的 III 期 CMV 疫苗研究正在進行中，我很高興地告訴大家，該試驗已招募了超過 80% 的參與者。我們期待該研究盡快全面註冊。

In our early clinical programs, EBV, HIV and VZV vaccine trials are ongoing and our HSV program is in pre-clinical.

在我們的早期臨床項目中，EBV、HIV 和 VZV 疫苗試驗正在進行中，我們的 HSV 項目正處於臨床前階段。

Now let's look at our mRNA therapeutics portfolio on the next slide, and I'll highlight a few programs. We are excited to announce that our Phase III melanoma study with INT is now enrolling. And I'll share the Phase III design in a moment. Our rare disease programs addressing major unmet medical needs in propionic acidemia, methylmalonic acidemia and GSD1a are ongoing, and we will look forward to sharing updates when the data are mature.

現在讓我們看看下一張幻燈片上的 mRNA 治療產品組合，我將重點介紹幾個項目。我們很高興地宣布，我們與 INT 合作的 III 期黑色素瘤研究現已開始入組。稍後我將分享第三階段的設計。我們的罕見病項目正在進行中，旨在解決丙酸血症、甲基丙二酸血症和 GSD1a 等主要未滿足的醫療需求，我們期待在數據成熟時分享最新信息。

Indeed, during the quarter, we presented an update on some of our PA program data at ASGCT. The dose confirmation part of the propionic acidemia study is currently ongoing. And lastly, our collaborators at Vertex are continuing to enroll in dose cystic fibrosis patients in the single ascending dose portion of that Phase I study.

事實上，在本季度，我們在 ASGCT 上展示了一些 PA 項目數據的更新。丙酸血症研究的劑量確認部分目前正在進行中。最後，我們在 Vertex 的合作者正在繼續在 I 期研究的單次劑量遞增部分中招募囊性纖維化患者。

Now on my last slide today, I want to take a moment to share the exciting Phase III trial design for our Individualized Neoantigen Therapy, or INT. This Phase III study is a randomized double-blind placebo-controlled study of the combination of INT plus KEYTRUDA against placebo plus KEYTRUDA in patients with resected melanoma at high risk of recurrence. The study will enroll approximately 1,089 resected melanoma patients, Stage IIB through IV with a 1:1 randomization. Each patient will receive up to 9 doses of INT every 3 weeks and KEYTRUDA every 6 weeks in the active arm or 9 doses of placebo every 3 weeks and KEYTRUDA every 6 weeks in the comparator arm. The primary endpoint is recurrence-free survival and secondary endpoints include Distant Metastasis-Free Survival and Overall Survival.

在今天的最後一張幻燈片上，我想花點時間分享我們的個體化​​新抗原療法 (INT) 令人興奮的 III 期試驗設計。這項 III 期研究是一項隨機雙盲安慰劑對照研究，針對複發風險高的已切除黑色素瘤患者，將 INT 加 KEYTRUDA 聯合療法與安慰劑加 KEYTRUDA 聯合療法進行比較。該研究將招募約 1,089 名切除的黑色素瘤患者，IIB 期至 IV 期，按 1:1 隨機分組。每位患者將在主動組中每 3 週接受最多 9 劑 INT，每 6 週接受 KEYTRUDA；在比較組中，每 3 週接受 9 劑安慰劑，每 6 週接受 KEYTRUDA。主要終點是無復發生存期，次要終點包括無遠處轉移生存期和總生存期。

I'm incredibly impressed with the collaboration between the Moderna and Merck scientific and clinical teams to rapidly stand up and begin enrolling this Phase III study.

Moderna 和默克科學和臨床團隊之間的合作給我留下了深刻的印象，他們迅速站起來並開始招募這項 III 期研究。

And with that, I'll turn it over to Arpa.

有了這個，我就把它交給 Arpa。

Thank you, Stephen, and good day to everyone. I'll start with a review of sales in the quarter and the first half of 2023.

謝謝你，斯蒂芬，祝大家有美好的一天。我首先回顧一下 2023 年季度和上半年的銷售情況。

In the second quarter of 2023, we reported approximately $300 million of COVID vaccine sales, which was in line with our expectations given the seasonal nature of endemic respiratory vaccine businesses. Sales of $2.1 billion for the first half of 2023 met our expectations. As a reminder, the sales in the first half were predominantly from mRNA-1273.222, which is our COVID vaccine targeting the BA.4, BA.5 variant. As you heard earlier from Stephen, regulators and health authorities around the world have selected the XBB.1.5 variant for the fall 2023 season. We have submitted applications to regulators globally for our updated vaccine and we are now awaiting approvals and authorizations. Subject to regulatory approvals, we expect additional sales in the second half of 2023, primarily from mRNA-1273.815.

2023 年第二季度，我們報告了大約 3 億美元的新冠疫苗銷售額，考慮到地方性呼吸道疫苗業務的季節性，這符合我們的預期。 2023 年上半年銷售額 21 億美元，符合我們的預期。提醒一下，上半年的銷售主要來自 mRNA-1273.222，這是我們針對 BA.4、BA.5 變體的新冠疫苗。正如您之前從 Stephen 那裡聽到的，世界各地的監管機構和衛生當局已為 2023 年秋季季節選擇了 XBB.1.5 變體。我們已向全球監管機構提交了更新疫苗的申請，目前正在等待批准和授權。待監管部門批准後，我們​​預計 2023 年下半年會有額外銷售，主要來自 mRNA-1273.815。

Turning now to the 2023 COVID sales outlook. We are updating our COVID sales expectation for 2023 to be in the range of $6 billion to $8 billion with the key variable being vaccination rates from the United States. Our 2023 sales mix consists of $2.1 billion in sales already recorded in the first half of this year, another $2 billion in sales from previously signed advanced purchase agreements for the second half delivery from several countries, including those listed in the middle column on this slide.

現在轉向 2023 年新冠疫情銷售前景。我們正在更新 2023 年新冠肺炎銷售額預期，將在 60 億至 80 億美元之間，其中關鍵變量是美國的疫苗接種率。我們 2023 年的銷售組合包括今年上半年已記錄的 21 億美元銷售額，以及先前簽署的下半年交付預購協議的另外 20 億美元銷售額，這些國家包括本幻燈片中間列中列出的國家。

Recent discussions with customers around the world have resulted in confirmed contracts of $2 billion for delivery in the second half of this year, updated from the originally expected $3 billion. Approximately $1 billion of the original $3 billion are now expected to be deferred to 2024. Also now included in the total expected 2023 COVID sales range of $6 billion to $8 billion is an additional $2 billion to $4 billion in sales expected from signed and anticipated commercial contracts in the U.S. as well as other markets such as Japan and the EU. The U.S. commercial contracts are a sizable portion of additional new sales expected in the second half of this year, so let me provide some color on that market in particular.

最近與世界各地客戶的討論已確認今年下半年交付的價值 20 億美元的合同，較最初預計的 30 億美元有所更新。最初的30 億美元中的約10 億美元現在預計將推遲到2024 年。現在還包括在2023 年新冠疫情預期銷售額60 億至80 億美元範圍內，預計已簽署和預期的商業銷售額將增加20 億至40 億美元。美國以及日本和歐盟等其他市場的合同。美國商業合同佔今年下半年預計新增銷售的相當大一部分，因此讓我特別介紹一下該市場的情況。

As you are aware, the COVID vaccine market in the U.S. has shifted to a commercial market with the transition from the pandemic to the endemic phase. In the U.S., the commercial vaccines market is made up of many different customer segments, including retail pharmacies, wholesalers, group purchasing organizations, integrated delivery networks, health systems, government entities, employers and other providers. Today, I am happy to report that we have signed contracts in each of these customer segments and continue to work on additional contracts. We are ready with ample supply to be shipped upon regulatory approval.

如您所知，隨著從大流行階段過渡到流行階段，美國的新冠疫苗市場已轉向商業市場。在美國，商業疫苗市場由許多不同的客戶群組成，包括零售藥店、批發商、團購組織、綜合交付網絡、衛生系統、政府實體、雇主和其他提供商。今天，我很高興地向大家報告，我們已經在每個客戶群中籤署了合同，並繼續致力於其他合同的工作。我們已準備好充足的供應，待監管部門批准後即可發貨。

Our science contracts give us visibility into the expected U.S. launch in the coming weeks and confidence in the additional sales we expect in the second half of 2023 from new orders.

我們的科學合同使我們能夠了解未來幾週預計在美國的推出情況，並對我們預計 2023 年下半年新訂單帶來的額外銷售充滿信心。

Let me now turn to Slide 21 to help frame the fall of 2023 U.S. COVID market. As I mentioned earlier, a key determinant for the market size in the U.S. will be vaccine uptake or shots and arms during the upcoming September to December time frame. As I've mentioned before, our expected 2023 sales range of $6 billion to $8 billion will be primarily driven by vaccination rates in the U.S. market. Earlier in the year, we provided parameters that informed our U.S. fall volume forecast for 2023, which included the roughly 50 million doses administered in the U.S. in the fall of 2022, 82 million Americans in the high-risk category for those who are over 50 with a comorbidity or those over the age of 65 and an average of 150 million doses of flu vaccines given in the U.S. every year for the last 9 years, which we believe is a reasonable proxy for a seasonal respiratory vaccine especially given the higher burden of disease with COVID.

現在讓我轉向幻燈片 21，以幫助了解 2023 年美國新冠肺炎市場的下跌情況。正如我之前提到的，美國市場規模的一個關鍵決定因素將是即將到來的 9 月至 12 月期間的疫苗接種或註射和武器。正如我之前提到的，我們預計 2023 年的銷售額將達到 60 億至 80 億美元，這主要取決於美國市場的疫苗接種率。今年早些時候，我們提供了美國 2023 年秋季接種量預測的參數，其中包括 2022 年秋季美國接種的約 5000 萬劑疫苗，其中 8200 萬美國人屬於 50 歲以上的高風險人群患有合併症或年齡超過65 歲的人，過去9 年在美國平均每年接種1.5 億劑流感疫苗，我們認為這是季節性呼吸道疫苗的合理替代指標，特別是考慮到流感疫苗的負擔較高患有新冠肺炎的疾病。

These parameters supported a volume forecast of 100 million doses for the U.S. market for fall 2023, but the fact of the matter is, in this first transition year to a commercial endemic market, it is difficult to accurately predict market volumes and predict how many Americans will come in this fall for their shots. As such, we look to Southern Hemisphere countries where the COVID season occurs during their fall/winter months to inform potential vaccination uptake in the U.S. as well. Specifically in Australia, where they are just completing their 2023 COVID season, the vaccination rate was 19% and populations where the booster vaccine was recommended. The Australian data, combined with prior year comparisons indicate U.S. market volumes for fall of 2023 to be in the range of 50 million to 100 million doses and this supports our U.S. sales expectations for the second half of the year.

這些參數支持了 2023 年秋季美國市場銷售量為 1 億劑的預測，但事實是，在向商業流行市場過渡的第一個年中，很難準確預測市場量並預測有多少美國人將在今年秋天進行拍攝。因此，我們關注在秋季/冬季出現新冠肺炎季節的南半球國家，以了解美國潛在的疫苗接種情況。特別是在剛剛結束 2023 年新冠肺炎季節的澳大利亞，疫苗接種率為 19%，並且推薦接種加強疫苗。澳大利亞數據與上年比較表明，2023 年秋季美國市場銷量將在 5000 萬至 1 億劑之間，這支持了我們對今年下半年美國銷售的預期。

Moving to Slide 22. I'm excited to share the fall vaccination campaigns for the updated COVID vaccine launch. Moderna's fall vaccine campaigns are two-pronged and are focused on: first, increasing the market size through disease awareness programs and secondly, on solidifying Moderna's market share with branded promotion. With our disease awareness campaigns, we are aiming to educate on disease burden, clarify the latest recommendations from ACIP and connect COVID-19 with seasonal flu vaccines with the goal to drive consumers to get vaccinated this fall. Branded promotion campaigns will focus on driving brand preference from Moderna's vaccine running direct-to-consumer campaigns across major media channels and conducting promotions with health care providers. The commercial team is highly energized for the launch of the updated COVID vaccine.

轉向幻燈片 22。我很高興與大家分享更新的新冠疫苗推出的秋季疫苗接種活動。 Moderna 的秋季疫苗活動是雙管齊下的，重點是：首先，通過疾病意識計劃擴大市場規模，其次，通過品牌推廣鞏固 Moderna 的市場份額。通過我們的疾病意識活動，我們的目標是就疾病負擔進行教育，澄清 ACIP 的最新建議，並將 COVID-19 與季節性流感疫苗聯繫起來，目標是推動消費者在今年秋天接種疫苗。品牌促銷活動將側重於通過主要媒體渠道開展直接面向消費者的活動，並與醫療保健提供者進行促銷活動，以提高 Moderna 疫苗的品牌偏好。商業團隊對於更新版新冠疫苗的推出充滿熱情。

Moving on to Slide 23. We are continuing to prepare for a potential 2024 launch of our RSV vaccine and are excited about the opportunity in front of us. We believe our vaccine has the best-in-class profile. This includes consistent high efficacy across vulnerable and older populations, as shown in the strong clinical data that we have shared. Additionally, our safety profile is well established. We now have administered more than 1 billion COVID vaccine doses using the same mRNA technology as our RSV vaccine.

繼續看幻燈片 23。我們正在繼續為 2024 年可能推出的 RSV 疫苗做準備，並對擺在我們面前的機會感到興奮。我們相信我們的疫苗具有同類最佳的特性。正如我們分享的強有力的臨床數據所示，這包括對弱勢群體和老年人群的持續高效。此外，我們的安全狀況也很完善。現在，我們已經使用與 RSV 疫苗相同的 mRNA 技術接種了超過 10 億劑新冠疫苗。

In our Phase III study, most solicited adverse events were mild to moderate. An mRNA-1345 in our Phase III RSV trial has not had any reported cases of GBS events as of the April 30 cutoff date. And finally, one important differentiator for us and for our customers at launch will be the presentation of the product, which will be exclusively in ready-to-use pre-filled syringes. This packaging allows health care professionals to conveniently dose consumers with a ready-to-use formulation. We believe this will save time and reduce errors in comparison to the reconstituted drug products on the market.

在我們的 III 期研究中，大多數不良事件都是輕度至中度。截至 4 月 30 日截止日期，我們 III 期 RSV 試驗中的 mRNA-1345 尚未報告任何 GBS 事件病例。最後，對於我們和我們的客戶來說，推出時的一個重要區別在於產品的展示，該產品將專門採用即用型預填充注射器。這種包裝使醫療保健專業人員能夠方便地為消費者提供即用型配方。我們相信，與市場上的重組藥品相比，這將節省時間並減少錯誤。

We continue to invest in pre-launch activities and are prepared for next year's potential launch. Our commercial team is active globally, and our manufacturing organization is well prepared to deliver the vaccine.

我們繼續投資於發布前活動，並為明年的潛在發布做好準備。我們的商業團隊在全球活躍，我們的製造組織已做好交付疫苗的充分準備。

With that, I will turn it over to Jamey.

這樣，我就把它交給傑米了。

Thanks, Arpa, and hello, everyone. This morning, I will cover our second quarter financial performance and provide a framework for our full year financial outlook. Starting on Slide 25.

謝謝阿帕，大家好。今天早上，我將介紹我們第二季度的財務業績，並為我們的全年財務前景提供一個框架。從幻燈片 25 開始。

Total product sales were $293 million, down 94% year-over-year, mainly driven by lower sales volume. We continue to expect 2023 to be a transitional year as we move from a pandemic to an endemic commercial market with significant seasonality. In line with our expectations, sales in the second quarter were relatively low, while we came in at the high end of our communicated range. Cost of sales for the second quarter of 2023 was $731 million.

產品總銷售額為 2.93 億美元，同比下降 94%，主要是由於銷量下降。我們仍然預計 2023 年將是過渡年，因為我們將從大流行轉向具有明顯季節性的地方性商業市場。與我們的預期一致，第二季度的銷售額相對較低，而我們的銷售額處於溝通範圍的高端。 2023 年第二季度的銷售成本為 7.31 億美元。

In addition to unit-driven manufacturing costs, this includes the following charges: $464 million for inventory write-downs related to excess and obsolete COVID-19 product, unutilized manufacturing capacity of $135 million and losses on firm purchase commitments of $75 million. These charges, other than royalties, were primarily driven by a shift in product demand to our latest monovalent XBB.1.5 COVID vaccine candidate and an overall lower market size compared to our expectations at the beginning of the year.

除了單位驅動的製造成本外，這還包括以下費用：與過剩和過時的 COVID-19 產品相關的庫存減記 4.64 億美元、1.35 億美元的未利用製造能力以及 7500 萬美元的確定採購承諾損失。除特許權使用費外，這些費用主要是由於產品需求轉向我們最新的單價 XBB.1.5 COVID 候選疫苗以及與我們年初的預期相比整體市場規模較小所致。

In order to have ample supply at the beginning of the 2023 fall season, we prepared for various outcomes of the strain selection resulting in additional cost to the P&L. The fact that a monovalent was chosen also meant that we were not able to use previously manufactured semi-finished goods.

為了在 2023 年秋季開始時有充足的供應，我們為菌株選擇的各種結果做好了準備，從而導致損益表增加成本。選擇一價的事實也意味著我們無法使用以前製造的半成品。

R&D expenses were $1.1 billion, which increased by 62% versus prior year. The increase in R&D continued to be driven by clinical trial-related expenses, particularly with our Phase III studies for RSV, seasonal flu and CMB. The increase in R&D is also attributable to increases in personnel costs due to increased head count to support our research and late-stage development efforts.

研發費用為 11 億美元，比上年增長 62%。研發的增長繼續受到臨床試驗相關費用的推動，特別是我們針對 RSV、季節性流感和 CMB 的 III 期研究。研發的增加還歸因於人員成本的增加，這是由於支持我們的研究和後期開發工作的人員數量增加所致。

SG&A expenses were $332 million, reflecting an increase of 57% year-over-year. The growth in spending was primarily driven by continued investments in personnel and outside services in support of our digital initiatives, marketed products, related commercialization activities as well as our company expansion.

SG&A 費用為 3.32 億美元，同比增長 57%。支出的增長主要是由於對人員和外部服務的持續投資推動的，以支持我們的數字計劃、營銷產品、相關商業化活動以及我們的公司擴張。

Income tax was a benefit of $369 million for the second quarter, mainly due to a loss from operations. Net loss for the period was $1.4 billion compared to net income of $2.2 billion last year and diluted loss per share was $3.62 compared to diluted earnings per share of $5.24 in 2022.

第二季度所得稅收益為 3.69 億美元，主要是由於運營虧損。該期間淨虧損為 14 億美元，而去年淨利潤為 22 億美元；攤薄每股虧損為 3.62 美元，而 2022 年攤薄每股收益為 5.24 美元。

We ended Q2 with cash and investments of $14.6 billion compared to $16.4 billion at the end of the first quarter. The decrease was driven by our net loss in the period and an approximately $600 million of share buybacks. Cash deposits for future product supply declined during the quarter by approximately $100 million to $1.7 billion by the end of the second quarter, which was in line with our expectations.

截至第二季度末，我們的現金和投資為 146 億美元，而第一季度末為 164 億美元。這一下降是由於我們期內的淨虧損和約 6 億美元的股票回購所致。用於未來產品供應的現金存款在本季度下降了約 1 億美元，到第二季度末降至 17 億美元，這符合我們的預期。

Now turning to Slide 27. I want to give an update on the progress we have made on our capital allocation priorities. Our top investment priority has been and will continue to be reinvesting in the base business. R&D spending in the first half of 2023 increased 80% year-over-year to $2.3 billion, and we remain on track to invest $4.5 billion in R&D for the full year. We are also investing in our digital capabilities, the commercial build-out of the organization as well as expanding our manufacturing footprint. We've accelerated our capital expenditures in 2023 as we expand both our international and U.S. manufacturing footprint.

現在轉向幻燈片 27。我想介紹一下我們在資本配置優先事項方面所取得的進展的最新情況。我們的首要投資重點一直是並將繼續對基礎業務進行再投資。 2023 年上半年的研發支出同比增長 80%，達到 23 億美元，全年研發投資額仍將達到 45 億美元。我們還投資於我們的數字能力、組織的商業建設以及擴大我們的製造足跡。隨著我們擴大國際和美國的製造足跡，我們在 2023 年加快了資本支出。

Our second investment priority is to seek attractive external investments and collaboration opportunities that will enable and complement our platform. We remain disciplined in our approach and are in multiple active discussions.

我們的第二個投資重點是尋求有吸引力的外部投資和合作機會，以支持和補充我們的平台。我們在方法上保持嚴格，並正在進行多次積極的討論。

After evaluating internal and external investment opportunities, we then assess additional uses of cash. In the first half of 2023, we repurchased 8 million shares for approximately $1.2 billion and we had $1.7 billion of share repurchase authorization remaining as of June 30, 2023.

在評估內部和外部投資機會後，我們會評估現金的額外用途。 2023 年上半年，我們以約 12 億美元回購了 800 萬股股票，截至 2023 年 6 月 30 日，我們還剩 17 億美元的股票回購授權。

Now let's turn to our updated 2023 financial framework on Slide 28. We would like to share our thinking beyond the advanced purchase agreements. As Arpa mentioned earlier, we now expect product sales for 2023 in the range of $6 billion to $8 billion comprising of approximately $4 billion from existing APAs and approximately $2 billion to $4 billion from additional sales to the U.S., Japan, EU and other countries. As a result of recent discussions with customers around the world, we now expect approximately $1 billion of the original total $5 billion in APAs to be deferred to 2024.

現在讓我們轉向幻燈片 28 上更新的 2023 年財務框架。我們想分享我們在高級採購協議之外的想法。正如Arpa 之前提到的，我們現在預計2023 年的產品銷售額將在60 億至80 億美元之間，其中約40 億美元來自現有預約定價安排，約20 億至40 億美元來自對美國、日本、歐盟和其他國家的額外銷售。根據最近與世界各地客戶的討論，我們現在預計最初 50 億美元的 APA 總額中的大約 10 億美元將推遲到 2024 年。

Second half sales timing 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 sales split of 30% in Q3 and 70% in Q4.

下半年的銷售時間將取決於全球監管機構批准的時間以及第三季度的可用發貨天數。我們目前預計第三季度的銷售額佔比為 30%，第四季度的銷售額佔比為 70%。

We now expect cost of sales for the full year in the range of $3.5 billion to $4 billion. At this point of the year, our production costs are largely fixed and only a smaller portion is driven by the sales outcome. Therefore, we thought it would be more helpful to provide you an absolute dollar range for your modeling purposes.

我們現在預計全年銷售成本在 35 億美元至 40 億美元之間。每年的這個時候，我們的生產成本基本上是固定的，只有一小部分是由銷售結果驅動的。因此，我們認為為您的建模目的提供絕對的美元範圍會更有幫助。

For R&D and SG&A, we continue to expect full year expenses to be approximately $6 billion, with approximately $4.5 billion in research and development. We now anticipate a full year tax benefit in the range of $0.7 billion to $1 billion, driven by an assumed operating loss, R&D credits, international provisions and nonrecurring items. And finally, we continue to expect capital expenditures of approximately $1 billion.

對於研發和銷售、一般管理費用（SG&A），我們繼續預計全年支出約為 60 億美元，其中研發費用約為 45 億美元。目前，我們預計全年稅收優惠將在 7 億至 10 億美元之間，這主要是由假設的運營虧損、研發信貸、國際撥備和非經常性項目推動的。最後，我們仍然預計資本支出約為 10 億美元。

That concludes my prepared remarks, and I'll turn the call back over to Stéphane.

我準備好的發言就到此結束，我會將電話轉回給斯蒂芬。

Thank you, Jamey, Arpa and Stephen.

謝謝杰米、阿帕和斯蒂芬。

Moderna has a promising commercial outlook, starting with COVID. While there is uncertainty in vaccination rates as we transition from a pandemic to endemic market, our APAs and U.S. commercial contracts underpin our expected 2023 COVID revenue in the range of $6 billion to $8 billion. We believe this first endemic here will provide visibility to recurring revenue stream. I believe we will be selling COVID vaccines for a very long time and we are working to combine COVID and flu into a single vaccine.

從新冠疫情開始，Moderna 的商業前景一片光明。儘管隨著我們從大流行市場過渡到流行市場，疫苗接種率存在不確定性，但我們的 APA 和美國商業合同支撐著我們預計 2023 年新冠疫情收入在 60 億至 80 億美元之間。我們相信，這裡的第一個流行病將為經常性收入流提供可見性。我相信我們將在很長一段時間內銷售新冠病毒疫苗，並且我們正在努力將新冠病毒和流感結合成單一疫苗。

Moving to RSV. RSV vaccine has a strong product profile and a differentiated pre-filled syringe presentation that should work through our advantage in the anticipated 2024 launch. In oncology, we are scaling our IoT manufacturing capacity to be ready for commercialization. The Phase II data are very strong, and we are now in Phase III with melanoma indication.

轉向 RSV。 RSV 疫苗具有強大的產品概況和差異化的預填充注射器外觀，這應該會在預計 2024 年推出時發揮我們的優勢。在腫瘤學領域，我們正在擴大物聯網製造能力，為商業化做好準備。 II 期數據非常強勁，我們現在正處於黑色素瘤適應症的 III 期。

With our partner, Merck, we are working to prioritize indications beyond those already announced, which are melanoma and non-small cell lung cancer.

我們與我們的合作夥伴默克公司一起，正在努力優先考慮已宣布的適應症，即黑色素瘤和非小細胞肺癌。

Stepping back and looking at the broad portfolio, I'm very excited that we are playing with a high-case scenario of Moderna with positive clinical data in infectious disease vaccine, in oncology, and in rare genetic disease of liver. Over the next 3 years, from '24, '25, '26, we anticipate multiple product launches across our vaccine and therapeutics portfolio that will position the company for strong sales growth. This is an incredibly exciting time at Moderna as we enter a new era with diversified revenue stream and a robust pipeline.

退後一步，看看廣泛的產品組合，我很高興我們正在研究 Moderna 的高案例場景，在傳染病疫苗、腫瘤學和罕見的肝臟遺傳病方面擁有積極的臨床數據。在未來 3 年中，從 24 年、25 年到 26 年，我們預計我們的疫苗和治療產品組合將推出多種產品，這將使公司實現強勁的銷售增長。對於 Moderna 來說，這是一個令人難以置信的激動人心的時刻，因為我們進入了一個擁有多元化收入來源和強大管道的新時代。

The platform is working, and the result will be an unprecedented number of mRNA launches in a very short time.

該平台正在發揮作用，其結果將是在很短的時間內推出前所未有的 mRNA 數量。

We look forward to updating you further at our upcoming R&D Day on September 13. That event will be live in New York City and, of course, also available online. On December 7, we'll be hosting our second annual ESG Day. This event will be online. The mission of our company is to deliver the greatest possible impact to people through MRNA medicines. This mission is especially relevant now as we approach the launch of multiple new medicines that should extend human lives and alleviate patient suffering. All of our stakeholders are poised to benefit as Moderna continues to deliver on its potential. It is a privilege for all of us to be part of this company.

我們期待在 9 月 13 日即將到來的研發日向您提供進一步的最新消息。該活動將在紐約市現場直播，當然也可以在線觀看。 12 月 7 日，我們將舉辦第二屆年度 ESG 日。本次活動將以線上形式進行。我們公司的使命是通過 mRNA 藥物為人們帶來最大的影響。現在，隨著我們即將推出多種新藥，以延長人類生命並減輕患者痛苦，這一使命尤其重要。隨著 Moderna 繼續發揮其潛力，我們所有的利益相關者都將受益。成為這家公司的一員是我們所有人的榮幸。

We'll now take questions. Operator?

我們現在開始提問。操作員？

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

（操作員說明）我們的第一個問題來自高盛的 Salveen Richter。

With regard to the expected additional sales for second half deliveries, can you speak to the spectrum of factors in addition to the U.S. vaccination rates that might impact reaching the higher end of that range? And can you discuss confidence that additional contracts wouldn't be pushed to 2024 as the fall season plays out?

關於下半年交付的預期額外銷售，您能否談談除了美國疫苗接種率之外可能影響達到該範圍上限的一系列因素？您能否討論一下，隨著秋季賽季的結束，額外合同不會被推遲到 2024 年？

Thank you for the question. So in terms of the additional sales of $2 billion to $4 billion, as you mentioned, the key factor of landing within that $6 billion to $8 billion is really around how many Americans this fall come in to get their shot. So vaccination rate is the biggest swing factor within that range. We are confident in our market share and the progress that we've been making with commercial contracts thus far in the U.S.

感謝你的提問。因此，正如您所提到的，就 20 億至 40 億美元的額外銷售額而言，實現 60 億至 80 億美元目標的關鍵因素實際上取決於今年秋天有多少美國人前來嘗試。因此，疫苗接種率是該範圍內最大的波動因素。我們對我們的市場份額以及迄今為止在美國商業合同方面取得的進展充滿信心。

Additionally, outside of the U.S., to your question on additional contracts potentially being deferred, we have met with all of the different countries where we have advanced purchase agreements and have already confirmed deliveries for the second half of this year, other than the $1 billion, which was pushed into 2024. So we're confident in staying at that $2 billion range.

此外，在美國之外，對於您關於可能推遲的額外合同的問題，我們已經與所有已達成採購協議的不同國家進行了會面，並已確認今年下半年的交付（10 億美元除外） ，推遲到2024 年。因此，我們有信心保持在20 億美元的範圍內。

Our next question comes from Tyler Van Buren with TD Cowen.

我們的下一個問題來自泰勒·範布倫 (Tyler Van Buren) 和 TD Cowen。

So with the COVID-19 vaccine sales of $6 billion to $8 billion expected for the year, how should we think about what that implies for real demand as we think about the eventual COVID-19 vaccine franchise tail? Is it $2 billion to $4 billion since the $4 billion was already locked in from APAs at the start of the year from prior years? If not, what proportion of the $4 billion of APAs would you consider true annual booster demand? Perhaps, is it the $2 billion expected in the second half? Thoughts there would be helpful.

因此，預計今年 COVID-19 疫苗銷售額將達到 60 億至 80 億美元，當我們考慮最終的 COVID-19 疫苗特許經營尾部時，我們應該如何考慮這對實際需求意味著什麼？是 20 億美元到 40 億美元嗎？因為今年年初預約定價安排中已經鎖定了往年的 40 億美元？如果不是，您認為 40 億美元預約定價安排中真正的年度刺激需求佔多大比例？或許，就是下半年預計的20億美元？那裡的想法會有幫助。

Thank you for the question. So in terms of how we're thinking about 2024, I would look at the first half of 2023, where we have recently reported $2.1 billion of sales. A portion of that volume is volume that we do not anticipate as a recurring sale in the outer years, given most countries are going towards fall vaccination campaigns with annual shot. For the remainder of the $4 billion to $6 billion, we do believe that vaccine demand will remain. And over time, eventually increase as we think about the flu volumes that we believe the COVID vaccination rates will start trending to.

感謝你的提問。因此，就我們如何看待 2024 年而言，我會關注 2023 年上半年，我們最近報告的銷售額為 21 億美元。鑑於大多數國家正在開展每年一次的秋季疫苗接種活動，因此我們預計該銷量的一部分不會在外部年份中經常銷售。對於剩餘的 40 億至 60 億美元，我們確實相信疫苗需求將會持續存在。隨著時間的推移，當我們考慮到我們相信新冠疫苗接種率將開始出現的流感數量時，最終會增加。

So as I mentioned earlier, for example, in the United States, there are about 150 million flu vaccines given every fall. What we've modeled for 2023 is the range of 50 million to 100 million. And we think over time, given the high disease burden and also as we think about future combinations, we will start trending closer to about 150 million.

所以正如我前面提到的，例如在美國，每年秋天大約會接種1.5億劑流感疫苗。我們為 2023 年建模的範圍是 5000 萬到 1 億。我們認為，隨著時間的推移，考慮到高疾病負擔以及我們考慮未來的組合，我們將開始接近 1.5 億左右。

Our next question comes from Gena Wang with Barclays.

我們的下一個問題來自巴克萊銀行的 Gena Wang。

Two very quick questions. Regarding the COVID U.S. commercial contract that signed, were there any definitive initial stocking order? And second, regarding the RSV vaccine, given that Pfizer and the GSK label language and a slow initial launch, any learning you could have for your approval and the launch prep?

兩個非常快的問題。關於簽署的新冠美國商業合同，是否有明確的初始備貨訂單？其次，關於 RSV 疫苗，考慮到輝瑞和葛蘭素史克的標籤語言以及初始推出的緩慢，您在批准和上市準備方面可以學到什麼？

Thank you. So I'll take the first question around U.S. contracts first. In our contracting progress, we do have minimum volume commitments across many of our commercial contracts. But most of our contracts were looking at minimum commitments and depending on vaccination uptake that we will be monitoring closely with our customers, that volume could go up over time.

謝謝。因此，我將首先回答有關美國合同的第一個問題。在我們的合同進展中，我們確實在許多商業合同中做出了最低數量承諾。但我們的大多數合同都考慮了最低承諾，並且根據我們將與客戶密切監控的疫苗接種情況，該數量可能會隨著時間的推移而增加。

In terms of the recent RSV ACIP meeting, we think the ACIP recommendation for a shared clinical decision-making will mean a more gradual uptake for the first two vaccines that have been approved. Though as we believe there is more data from both our clinical program as well as GSK and Pfizer's clinical programs, we do believe there is opportunity to potentially update that recommendation, which would, over time, lead to a broader uptake of the RSV vaccine.

就最近的 RSV ACIP 會議而言，我們認為 ACIP 關於共同臨床決策的建議將意味著更逐步地採用已批准的前兩種疫苗。儘管我們相信我們的臨床計劃以及葛蘭素史克和輝瑞的臨床計劃有更多數據，但我們確實相信有機會更新該建議，隨著時間的推移，這將導致 RSV 疫苗的更廣泛採用。

Our next question comes from Michael Yee with Jefferies.

我們的下一個問題來自 Jefferies 的 Michael Yee。

This is Dina on for Mike. Just a quick question on the flu update. So I saw that you guys are doing a Q3 update for the second immunogenicity study and then going on to have data in Q3 with that, but how about the efficacy study from that second infection or that -- yes, that previous infection study, what are your time lines for that? Have that shifted? Are you going to share that? And also on PCV, are you going to be sharing any additional updates on the regulatory path moving forward? Or are you sharing any other updates on lung, et cetera?

這是迪娜為邁克代言的。關於流感最新情況的一個簡單問題。所以我看到你們正在為第二次免疫原性研究進行第三季度更新，然後繼續在第三季度獲得數據，但是第二次感染的功效研究怎麼樣——是的，之前的感染研究，什麼你的時間表是這樣的嗎？這已經改變了嗎？你會分享嗎？還有關於 PCV，您是否打算分享有關未來監管路徑的任何其他更新？或者您是否分享了有關肺部等方面的任何其他更新？

Thank you, Dina, for the question or questions. So -- so first, on the 1010 flu program, as you referenced, we have 2 ongoing. We have actually 3 ongoing Phase III studies, but 2 that are continuing to accrue data. We'll be providing updates on the efficacy study, the P302 study you referenced. And as you know, in our Vaccines Day, we talked about end of season update. And we'll also be sharing where we are in the pivotal P303 immunogenicity study. And as I said, we'll be doing that this quarter, and we're excited to continue to update on the progress in influenza.

謝謝你，迪娜，提出一個或多個問題。因此，首先，正如您提到的，關於 1010 流感計劃，我們正在進行 2 個計劃。我們實際上有 3 項正在進行的 III 期研究，但其中 2 項正在繼續積累數據。我們將提供功效研究（您提到的 P302 研究）的最新信息。如您所知，在我們的疫苗日，我們討論了賽季末的更新。我們還將分享關鍵的 P303 免疫原性研究的進展情況。正如我所說，我們將在本季度這樣做，我們很高興繼續更新流感方面的進展。

As it relates to INT. Now INT, not PCV, that program, we had a great opportunity to provide an update to you all and everyone at ASCO just a month ago. And we're going to be, of course, at our R&D Day, reprising that and also talking to some of the other progress happening in the INT program. We are obviously working hard to get up and running in our non-small cell lung cancer, but we're really -- pivotal studies, but we're really excited by the start of the first Phase III with melanoma study now, and we'll be providing further updates in a month in New York.

因為它與 INT 有關。現在是 INT，而不是 PCV，該計劃，一個月前我們有一個很好的機會向你們所有人以及 ASCO 的每個人提供最新信息。當然，我們將在研發日重申這一點，並討論 INT 計劃中發生的其他一些進展。顯然，我們正在努力啟動和運行我們的非小細胞肺癌，但我們確實是關鍵研究，但我們對現在第一個黑色素瘤 III 期研究的開始感到非常興奮，我們我們將在一個月內在紐約提供進一步的更新。

(Operator Instructions) Our next question comes from Ellie Merle with UBS.

（操作員說明）我們的下一個問題來自瑞銀集團的埃莉·梅爾 (Ellie Merle)。

This is Sarah on for Ellie. Just a follow-up on Tyler's earlier question. Thinking about COVID volumes going forward, can you give more color on how you're thinking about first half versus second half, particularly any color on your expectation for first half of next year? And then on CMV, any expectation on when you'll complete enrollment? And how we should think about when we could get data and maybe anything you're seeing on a blinded basis on the event rate?

這是莎拉為艾莉配音。只是泰勒之前問題的後續。考慮到未來的新冠疫情數量，您能否對上半年和下半年的看法提供更多信息，特別是您對明年上半年的預期？那麼對於 CMV，您對何時完成註冊有什麼期望嗎？我們應該如何考慮何時可以獲得數據以及您在事件發生率上盲法看到的任何內容？

So I'm happy to take the first question and then we'll hand it over to Stephen on CMV.

所以我很高興回答第一個問題，然後我們將其交給 CMV 的 Stephen。

In terms of how we're thinking about the first half versus second half going forward, in the first half of the year, sales that we expect will come from the Southern Hemisphere where it is their fall and winter season. Additionally, in some countries in the higher-risk populations, there continue to be spring campaigns and boosters, particularly for immuno-compromise, elderly and highest risk patients. So we do anticipate some sales coming in for the high-risk spring boost for the Southern Hemisphere as well as any carryover from late winter of this year into January. The majority of our sales will continue to be expected in the second half of the year though as the majority of our sales will be anticipated from the Northern Hemisphere and the fall vaccine campaign.

就我們如何看待上半年和下半年而言，我們預計上半年的銷售將來自南半球，那裡正值秋冬季節。此外，在一些高危人群的國家，繼續開展春季運動和加強活動，特別是針對免疫功能低下、老年人和高危患者。因此，我們確實預計南半球春季高風險的銷售將會帶來一些銷售，以及從今年冬末到一月的任何結轉。儘管我們的大部分銷售額預計將來自北半球和秋季疫苗接種活動，但預計我們的大部分銷售額將繼續在今年下半年實現。

Great. And a question on CMV enrollment. Yes, we're really excited by the recent acceleration towards completion of enrollment there. We're past 80%. We do hope to complete enrollment shortly. We've made good progress in the first half of this year. And so we haven't specifically set a target on that, but we would hope to enroll it for sure this year.

偉大的。還有一個關於 CMV 註冊的問題。是的，我們對最近加速完成那裡的註冊感到非常興奮。我們已經超過80%了。我們確實希望盡快完成註冊。今年上半年我們取得了良好進展。所以我們還沒有具體設定目標，但我們希望今年能確定註冊。

The -- then we will be accruing cases. And I think that's where it gets very interesting in tracking the CMV Phase III program. We've already started to accrue cases that we talked about in the Vaccines Day. And as we get to full enrollment, we will have more participants who can contribute cases to our first interim analysis of efficacy, which will be an event-driven analysis and so not something we can predict...

那麼我們將會積累案件。我認為這就是跟踪 CMV 第三階段計劃非常有趣的地方。我們已經開始積累我們在疫苗日討論過的病例。當我們達到全面註冊時，我們將有更多的參與者可以為我們的第一次中期療效分析貢獻案例，這將是一個事件驅動的分析，所以不是我們可以預測的......

Our next question comes from Luca Issi with RBC Capital.

我們的下一個問題來自 RBC Capital 的 Luca Issi。

Maybe one, Jamey, if I can circle back on margins. I think your prior guidance implied 60% to 65% gross margin versus your new guidance today implies 47% gross margin at the midpoint. Can you just maybe expand a little bit more on what's driving that change today? And then maybe Stephen on flu, I think Sanofi argued that the lower immunogenicity for the B strain could actually be a class effect. So it'd be difficult for any of the mRNA player to actually have strong immunogenicity for the B strain. Wondering what are your thoughts there?

也許是一個，傑米，如果我能回到邊緣的話。我認為你們之前的指導意味著毛利率為 60% 到 65%，而今天的新指導則意味著毛利率中點為 47%。您能否進一步闡述一下今天推動這一變化的因素？然後也許是斯蒂芬關於流感，我認為賽諾菲認為 B 株較低的免疫原性實際上可能是一種階級效應。因此，任何 mRNA 玩家都很難真正對 B 株具有強免疫原性。想知道你有什麼想法嗎？

Yes. Thanks, Luca. I'll take the first question.

是的。謝謝，盧卡。我來回答第一個問題。

So on margins, yes, you're right. We were planning for 60% to 65%. I'd say it's largely volume driven, $1 billion of APAs pushing out to 2024 as an example. We still have the cause for those fixed into our $3.5 billion to $4 billion in addition to other markets as well. So I think our volume expectation prior to this quarter was a little higher, some due to push out, some just due to overall volume that we anticipate coming through here.

所以在邊緣方面，是的，你是對的。我們原計劃是 60% 到 65%。我認為這主要是數量驅動的，例如，到 2024 年將有 10 億美元的預約定價安排。除了其他市場之外，我們仍然有理由將這些資金固定在 35 億至 40 億美元的市場中。因此，我認為我們在本季度之前的銷量預期略高，有些是由於推出，有些只是因為我們預計這裡的總體銷量。

And I'm aware of the argument that Sanofi made about a class effect. I'm not sure I see it the same way. I think we'll look to the data to answer that question rather than conjecture. We'll look forward to sharing where we are in the P303 Phase III study in the next quarter. And I'll leave it at that.

我知道賽諾菲關於階級效應的論點。我不確定我是否也這麼看。我認為我們會通過數據來回答這個問題，而不是猜測。我們期待在下個季度分享 P303 III 期研究的進展情況。我就這樣吧。

Our next question comes from Edward Tenthoff with Piper Sandler.

我們的下一個問題來自愛德華·滕托夫和派珀·桑德勒。

Great. Can you hear me okay?

偉大的。你能聽到我說話嗎？

Loud and clear.

響亮而清晰。

Great. So thanks for all the detail in the update. And my question is kind of a little bit of a longer-term strategic one. As COVID continues to evolve and then as you ultimately seek approval of 1010 and even RSV. What is the plan for combining these from a regulatory standpoint and then also a commercial standpoint? So how do we get from where we are today with 1 approved, maybe 2 -- 3 approved vaccines next year to 1 combo approved or multiple combo approved vaccines?

偉大的。感謝您提供更新中的所有詳細信息。我的問題有點像長期戰略問題。隨著新冠疫情的不斷發展，您最終會尋求 1010 甚至 RSV 的批准。從監管角度和商業角度來看，將這些結合起來的計劃是什麼？那麼，我們如何才能從今天批准的 1 種、明年可能是 2-3 種批准的疫苗發展到批准 1 種組合疫苗或多種組合批准的疫苗呢？

Thanks for the questions, Ed. So as you know, we've had -- as I said, we have 6 combo vaccines. We've got lots of clinical data out there. And we continue to look at new combinations. And if we're in a situation that we expect to be in, where we have a flu, RSV and COVID approved as well as second-generation COVID moving forward, you can be -- you can rest assure we'll be looking at multiple different combinations of those, trying to bring forward options that provide the greatest public health flexibility. Those studies, once we have the products approved, the monovalent vaccines, those studies are really just immune bridging studies, demonstrating that we can do the combination and achieve non-inferior immunogenicity and safety in those studies. They can be quite quick and they also don't need to be run in the season, as you know.

謝謝你的提問，艾德。如您所知，正如我所說，我們有 6 種組合疫苗。我們有大量的臨床數據。我們繼續尋找新的組合。如果我們處於我們預期的情況，即流感、呼吸道合胞病毒和新冠病毒獲得批准，以及第二代新冠病毒正在向前發展，您可以——您可以放心，我們會考慮這些措施的多種不同組合，試圖提出提供最大公共衛生靈活性的選擇。這些研究，一旦我們的產品獲得批准，單價疫苗，這些研究實際上只是免疫橋接研究，證明我們可以進行組合併在這些研究中實現非劣質的免疫原性和安全性。如您所知，它們可以非常快，而且也不需要在賽季中運行。

And so our goal is going to be, as we've said throughout this year, is to complete the work to move towards approval, filing and eventually, hopefully, approval of the 3 monovalent vaccines and quickly progressing into the pivotal Phase IIIs for at least 1 and multiple combos. Our goal, again, is to be launching those in '25 and beyond. So the obvious reason that they will improve compliance, deliver more value and actually decrease the administration cost of health care.

因此，正如我們今年全年所說的那樣，我們的目標是完成批准、備案並最終有望批准 3 種單價疫苗的工作，並迅速進入關鍵的 III 期臨床試驗。至少 1 個和多個組合。我們的目標是在 25 年及以後推出這些產品。因此，顯而易見的原因是它們將提高合規性，提供更多價值並實際上降低醫療保健的管理成本。

So the path is actually pretty clear from here, particularly given the strength of the RSV data and where we are in COVID, and we hope to be providing an update very shortly on flu that also provides a clear path for '24 in the monovalent launches we've guided. And then I think we'll clarify very quickly that we're starting the Phase IIIs to allow the combo launches very shortly thereafter.

因此，從這裡開始，路徑實際上非常清晰，特別是考慮到RSV 數據的強度以及我們在新冠病毒中所處的位置，我們希望很快提供有關流感的最新信息，這也為24 年的單價發布提供了明確的路徑我們已經指導過。然後我想我們會很快澄清，我們正在啟動第三階段，以便此後不久就可以推出該組合。

That's really helpful, Stephen. And just to clarify 1 point, if I may. When you said the pivotal Phase IIIs, those would be immuno-bridging studies?

這真的很有幫助，斯蒂芬。如果可以的話，我只是想澄清一點。當您提到關鍵的 III 期研究時，這些研究將是免疫橋接研究？

Immunogenicity -- correct. They're immunogenicity and safety studies. So very quick studies, just demonstrating. We do not believe nor is the norm from a regulatory perspective that you have to do subsequent efficacy studies once you've established the efficacy of the monovalent vaccines.

免疫原性——正確。它們是免疫原性和安全性研究。非常快速的研究，只是演示。我們不認為，從監管角度來看，一旦確定了單價疫苗的功效，就必須進行後續的功效研究，這也不是常態。

Our next question comes from Manos Mastorakis with Deutsche Bank.

我們的下一個問題來自德意志銀行的馬諾斯·馬斯托拉基斯。

Basically, I just wanted to ask in terms of the COGS guidance, does that apply regardless of the revenue range? And if not, what is the sensitivity range that you could provide?

基本上，我只是想問一下 COGS 指導，無論收入範圍如何，這都適用嗎？如果沒有，您可以提供的靈敏度範圍是多少？

Yes. Thanks for the question, Manos. Yes, it does apply regardless, as I mentioned in my prepared remarks, most of this cost is fixed at this point. We've already ordered the raw materials. We've already started manufacturing. Most of our -- we have got a lot of supply ready to go as soon as we are able to -- as soon as we get regulatory approval. So that $3.5 billion to $4 billion is not really dependent too much on the sales outcome that will happen either way.

是的。謝謝你的提問，馬諾斯。是的，無論如何，它確實適用，正如我在準備好的發言中提到的，大部分成本此時已固定。我們已經訂購了原材料。我們已經開始生產了。我們的大部分——一旦獲得監管部門的批准，我們就已經準備好了大量的供應。因此，35 億至 40 億美元實際上並不太依賴於無論哪種方式都會發生的銷售結果。

And maybe just to talk to longer term. So I think what we're suffering with this year is just an unpredictable market. So back to the prior question of the 35% to 40% or 60% to 65% gross margin. As it becomes more predictable, we will be able to order the right amount of material, you have the right amount of volume commitments that might not happen in 2024 as we've worked through some of our commitments. But we feel very confident in the overall 75% to 80% gross margin range in the long term.

也許只是為了談論更長遠的事情。所以我認為我們今年遇到的只是一個不可預測的市場。那麼回到之前的問題，即 35% 到 40% 或 60% 到 65% 的毛利率。隨著情況變得更加可預測，我們將能夠訂購適量的材料，您將獲得適量的批量承諾，而這在 2024 年可能不會實現，因為我們已經履行了一些承諾。但從長遠來看，我們對整體 75% 至 80% 的毛利率範圍非常有信心。

Our next question comes from Geoff Meacham with Bank of America.

我們的下一個問題來自美國銀行的傑夫·米查姆。

This is Alec on for Geoff. Can you talk about all the other potential indications you may pursue for the INT vaccine? And how will you decide which indications to pursue first? Will this be based on the facts like rationale or an unmet need? And then secondly, what commercial hurdles do you expect for flu and RSV given the entrenched competition and new entrants respectively?

這是亞歷克（Alec）替傑夫（Geoff）發言。您能否談談您可能尋求的 INT 疫苗的所有其他潛在適應症？您將如何決定首先追求哪些適應症？這是否基於諸如基本原理或未滿足的需求之類的事實？其次，考慮到根深蒂固的競爭和新進入者，您預計流感和 RSV 會面臨哪些商業障礙？

Great. Thank you for the question. So first -- so obviously, we're moving forward to melanoma, as you know. And we're moving forward to non-small cell lung cancer. I think the opportunity there, the unmet need there is obviously very significant. And as we know, that's one of the largest opportunity for immune therapies generally. And so it's an obvious place for us to go next.

偉大的。感謝你的提問。首先，很明顯，正如你所知，我們正在向黑色素瘤邁進。我們正在向非小細胞肺癌邁進。我認為那裡的機會和未滿足的需求顯然非常重要。正如我們所知，這是免疫療法的最大機會之一。因此，這顯然是我們下一步要去的地方。

As we've said before, we have not yet publicly guided with our partner, Merck, on what the other indications will be, but we have said that we are going to follow the path of all the places where PD-1 KEYTRUDA have been successful, but where we think there is still headroom, still opportunity to significantly improve upon what's been achieved with the PD-1 antibodies. And so you can follow through the adjuvant settings as well as perhaps some of the Stage IV settings where there are those benefits and expect us to be moving there in short order. Ourselves in Merck are in the process of finalizing some of those plans and at the appropriate time, obviously, we will guide you on the start of those studies.

正如我們之前所說，我們還沒有與我們的合作夥伴默克公司公開指導其他適應症，但我們已經說過，我們將遵循 PD-1 KEYTRUDA 已經經歷過的所有地方的道路成功，但我們認為仍有空間，仍然有機會顯著改進PD-1 抗體所取得的成就。因此，您可以遵循輔助設置以及可能有這些好處的一些第四階段設置，並期望我們很快就能實現這一目標。默克公司正在最終確定其中一些計劃，顯然，在適當的時候，我們將指導您開始這些研究。

But rest assured, as we've said and as they've said before, there is a quite large program of studies that will be ramping up here in very short order and melanoma and non-small cell lung cancer are really just the first 2.

但請放心，正如我們和他們之前所說的那樣，有一個相當大的研究計劃將在很短的時間內在這裡展開，黑色素瘤和非小細胞肺癌實際上只是前兩個。

And I can take the question on RSV and flu. We are very excited to be launching RSV next year. So while we will be bringing the third product to market, we're very confident in what we believe is a best-in-class profile with our consistently high effectiveness across high-risk groups, thinking about our well-established safety profile in the only mRNA platform for RSV and lastly, as I mentioned earlier, being the only product with a ready-to-use pre-filled syringe. So we're feeling really good about the RSV launch preparations, and we're ready to execute in 2024.

我可以回答有關呼吸道合胞病毒和流感的問題。我們很高興明年推出 RSV。因此，雖然我們將第三種產品推向市場，但我們對我們認為是一流的產品非常有信心，因為我們在高風險群體中始終保持高效，考慮到我們在RSV 的唯一mRNA 平台，最後，正如我之前提到的，它是唯一具有即用型預填充注射器的產品。因此，我們對 RSV 的發布準備工作感到非常滿意，並準備在 2024 年執行。

From a flu perspective, we do think one of the advantages of 1010, which would be our first generation flu vaccine is our speed to market could give us an opportunity for better strain matching in the future. And as we get enhanced profiles for flu, as Stephen mentioned earlier, from a commercial perspective, we see a tremendous amount of interest in our combination vaccines both from patients as well as from health care systems.

從流感的角度來看，我們確實認為 1010（我們的第一代流感疫苗）的優勢之一是我們的上市速度可以為我們在未來提供更好的毒株匹配的機會。正如斯蒂芬之前提到的，隨著我們對流感的認識不斷增強，從商業角度來看，我們看到患者和醫療保健系統對我們的組合疫苗表現出極大的興趣。

So having RSV and flu gives us an incredible opportunity for combinations in the future.

因此，呼吸道合胞病毒和流感為我們未來的組合提供了絕佳的機會。

Our next question comes from Evan Wang with Guggenheim Securities.

我們的下一個問題來自古根海姆證券公司的 Evan Wang。

I just wanted some thoughts on COVID. And as we're thinking ex-U.S., any details you can share in terms of size orders and market positioning in some of your markets like Japan? And what could change in 2024? And in flu, just great to see the P303 study for enrolled. Just want some updated thoughts in terms of confidence on hitting on some of the B strain given some of the competitive updates?

我只是想對新冠病毒有一些想法。當我們考慮美國以外的市場時，您可以分享一些關於日本等市場的訂單規模和市場定位的細節嗎？ 2024 年會發生什麼變化？在流感方面，很高興看到 P303 研究入選。只是想要一些關於在考慮到一些競爭更新後擊中某些 B 菌株的信心方面的更新想法嗎？

So I'll take the first question. From an ex-U.S. perspective, we have signed a minimum commitment with Japan that has been announced. The minimum commitment that we signed with Japan is just to get product into the country as soon as August and so we're ready to execute this fall. If their vaccine uptake expands, we do anticipate additional orders coming in from Japan.

那麼我來回答第一個問題。來自前美國從角度來看，我們已經與日本簽署了已宣布的最低承諾。我們與日本簽署的最低承諾是最快在八月份將產品運入該國，因此我們準備在今年秋天執行。如果他們的疫苗使用量擴大，我們確實預計來自日本的訂單會增加。

For the rest of the world, we have advanced purchase agreements that I have outlined already on in that first column as well as ongoing conversations with several other international markets, including those in the European Union.

對於世界其他地區，我們已經提前簽署了採購協議，我已經在第一專欄中概述了這一點，並且正在與包括歐盟在內的其他幾個國際市場進行對話。

In terms of 2024 changes. What we expect outside the U.S. is we expect more and more markets to actually be transitioning from central government procured to more of an endemic commercial market such as the transition that the U.S. is going through today. So we do anticipate changes. Most of those changes will be around shifting where the procurement is happening as well as changes in pricing and reimbursement going forward.

就2024年的變化而言。我們對美國以外的市場的預期是，越來越多的市場實際上將從中央政府採購轉向更多的地方性商業市場，例如美國今天正在經歷的轉變。所以我們確實預計會有變化。其中大部分變化將圍繞採購地點的變化以及未來定價和報銷的變化。

The flu question. So yes, we're fully enrolled in P303, ahead of schedule on that and we will provide data shortly on the P303 study this quarter as we said.

流感問題。所以，是的，我們提前完全註冊了 P303，正如我們所說，我們將很快在本季度提供 P303 研究的數據。

As far as B strains goes, we already updated earlier this year that actually in the P302 study, we achieved non-inferiority in the B strains. You'll remember in the P301 we just -- we had missed that. And so we were learning as we went. And we actually made a series of changes into the P303 study that we were confident and remain very confident, we'll provide a benefit in the B strains that will improve immunogenicity there.

就 B 菌株而言，我們今年早些時候已經更新，實際上在 P302 研究中，我們在 B 菌株中實現了非劣效性。您會記得在 P301 中我們只是 - 我們錯過了這一點。所以我們邊走邊學習。事實上，我們對 P303 研究進行了一系列改變，我們有信心並且仍然非常有信心，我們將在 B 菌株中提供益處，從而提高那裡的免疫原性。

So I remain quite optimistic that our understanding of science is really strong, we think best-in-class and that where we will be and when we look at that P303 data, ensure is in a very strong position as it relates to B strains and continue to be in a very strong position as it relates to the A strains.

因此，我仍然非常樂觀地認為，我們對科學的理解確實很強，我們認為是一流的，而且當我們查看 P303 數據時，我們會處於非常有利的位置，因為它與 B 菌株相關，並且與A菌株相關，繼續處於非常有利的地位。

And Kevin, we will take our last question.

凱文，我們將回答最後一個問題。

Our last question comes from Simon Baker with Redburn.

我們的最後一個問題來自雷德伯恩的西蒙·貝克。

Just 2 questions from me. One was, how has your view of the RSV opportunity changed in light of compared to 2-year data and the ACIP recommendation. In what regard do you think that you can achieve best-in-class profile? And the second question was just a little bit more about the CMV Phase III enrollment and if you think you'll be able to get full enrollment by this quarter?

我只有兩個問題。一是，與 2 年數據和 ACIP 建議相比，您對 RSV 機會的看法有何變化。您認為您可以在哪些方面取得一流的形象？第二個問題是關於 CMV 第三階段註冊的更多信息，您是否認為能夠在本季度之前獲得全面註冊？

I'll start with the RSV question. In light of the ACIP shared decision-making recommendation as well as some of the data that was shared this year around revaccination, we do anticipate a slower vaccine uptake at the start. In terms of our potential in that market, we do continue to be very confident that we have a best-in-class profile. And as we get additional data from our own vaccine program, we are hopeful that the ACIP recommendation will be broadened and could be -- will enable a faster uptick in outer years.

我將從 RSV 問題開始。根據 ACIP 的共同決策建議以及今年圍繞重新接種疫苗分享的一些數據，我們確實預計一開始疫苗的接種速度會較慢。就我們在​​該市場的潛力而言，我們仍然非常有信心擁有一流的形象。當我們從我們自己的疫苗計劃中獲得更多數據時，我們希望 ACIP 的建議能夠得到擴大，並且可能會在未來幾年實現更快的增長。

And the only thing I'd add to that in terms of the development side is we are obviously looking at multiple different versions of RSV combination vaccines and 1 of the advantages there will obviously be increased convenience and compliance. And that's where if we can create health care system value, I think it will be -- it will continue to evolve the recommendation that people have around that.

在開發方面，我唯一要補充的是，我們顯然正在研究多種不同版本的 RSV 組合疫苗，其中一個優勢顯然是增加便利性和合規性。如果我們能夠創造醫療保健系統的價值，我認為它將繼續發展人們對此的建議。

As it relates to CMV, so we haven't set out a guidance on when we would expect the enrollment to complete. But we are actually confident given the trajectory that we're already past 80% that we will complete enrollment this year, I'm not saying this quarter, but this year. And as I said, what really matters is probably not whether we're at 80% or 99% or 100% enrollment, it's the accrual of cases and events that will drive the first interim analysis from forward. Now obviously, more patients, more participants enrolled will increase the number of and pace of those events over time. And so we are focused very much on that operationally, and we do hope to have that completed this year.

由於它與 CMV 有關，因此我們尚未就預計註冊何時完成提供指導。但考慮到我們已經超過 80% 的軌跡，我們實際上有信心今年將完成招生，我不是說這個季度，而是今年。正如我所說，真正重要的可能不是我們的入學率是 80%、99% 還是 100%，而是病例和事件的累積將推動第一個中期分析的進行。現在顯然，隨著時間的推移，更多的患者、更多的參與者註冊將增加這些活動的數量和節奏。因此，我們非常關注運營方面的問題，我們確實希望今年能夠完成。

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

我想將電話轉回給 Stéphane，讓其作結束語。

Well, thank you very much for your questions. We look forward to seeing many of you in the next days and weeks, but especially seeing you at the R&D Day on September 13 to see many of you in person. Have a great day. Thank you.

嗯，非常感謝您的提問。我們期待在接下來的幾天和幾週內見到你們中的許多人，特別是在 9 月 13 日的研發日見到你們，以便親自見到你們中的許多人。祝你有美好的一天。謝謝。

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。