莫德納 (MRNA) 2022 Q2 法說會逐字稿

Good morning. My name is Kevin, and I'll be your operator today. Welcome to Moderna's Second Quarter 2022 Earnings Call. (Operator Instructions) Please be advised that this call is being recorded.

早上好。我的名字是凱文，今天我將成為你的接線員。歡迎來到 Moderna 的 2022 年第二季度財報電話會議。 （操作員說明）請注意，此通話正在錄音中。

At this time, I'd like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed.

此時，我想將電話轉給 Moderna 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 2022 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。大家早上好，感謝您加入我們今天的電話會議，討論 Moderna 2022 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，訪問今天上午發布的新聞稿以及我們將審查的幻燈片。

On today's call are Stephane Bancel, our Chief Executive Officer; David Meline, our Chief Financial Officer; Stephen Hoge, our President; Paul Burton, our Chief Medical Officer; and Arpa Garay, our Chief Commercial Officer.

今天的電話是我們的首席執行官 Stephane Bancel；我們的首席財務官 David Meline；我們的總裁斯蒂芬·霍格；我們的首席醫療官 Paul Burton；和我們的首席商務官 Arpa Garay。

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 和我們提交給 SEC 的重要風險因素可能導致我們的實際業績和結果與這些前瞻性陳述中明示或暗示的內容存在重大差異。

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

有了這個，我會把電話轉給 Stephane。

Thank you, Lavina. Good morning or good afternoon, everyone. Welcome to our Q2 2022 conference call. Today, I will start with a quick business review before Paul walks you through some new real-world evidence data on Spikevax. And then Stephen will review our clinical programs. Arpa will take you through commercial dynamics, and David will present financials. I will then come back to close, share some thoughts about where we're heading.

謝謝你，拉維娜。大家早上好或下午好。歡迎參加我們的 2022 年第二季度電話會議。今天，在 Paul 向您介紹有關 Spikevax 的一些新的真實世界證據數據之前，我將先進行一次快速的業務回顧。然後斯蒂芬將審查我們的臨床項目。 Arpa 將帶您了解商業動態，David 將介紹財務狀況。然後我會回來結束，分享一些關於我們前進方向的想法。

In the quarter, we continued strong financial performance. We reported revenue of $4.7 billion and net income of $2.2 billion. We were pleased with the Q2 sales. The decrease in net income is driven by higher cost of sales in the quarter, mostly driven by our COVAX contract, David will call that in the financials; a strong increase in R&D investments to fund our future, including the 4 Phase III programs; and the higher tax rate than Q2 2021.

在本季度，我們繼續強勁的財務表現。我們報告的收入為 47 億美元，淨收入為 22 億美元。我們對第二季度的銷售額感到滿意。淨收入下降是由於本季度銷售成本上升，主要是由我們的 COVAX 合同推動，大衛將在財務報表中稱其為；大力增加研發投資以資助我們的未來，包括 4 個第三階段計劃；以及比 2021 年第二季度更高的稅率。

Through our share repurchase program, we reduced our share count by 9 million shares in Q2. Since the start of our first share repurchase program in 2021 through yesterday, we have repurchased around 18 million shares. We continue to have signed advanced purchase agreement for expected delivery in 2022 in the amount of approximately $21 billion.

通過我們的股票回購計劃，我們在第二季度將股票數量減少了 900 萬股。自 2021 年首次股票回購計劃啟動到昨天，我們已經回購了大約 1800 萬股股票。我們繼續簽署預購協議，預計在 2022 年交付，金額約為 210 億美元。

Based on our commercial momentum and our balance sheet, today, we also announced that our Board of Directors has approved a new share buyback program for an additional $3 billion.

根據我們的商業勢頭和資產負債表，今天，我們還宣布我們的董事會已批准一項額外 30 億美元的新股票回購計劃。

Let me now review the business and pipeline update since our last review. I am pleased with the important progress the Moderna team has made on advancing the pipeline closer to product launches and increasing the breadth of the pipeline.

現在讓我回顧一下自上次回顧以來的業務和管道更新。我對 Moderna 團隊在推進管道更接近產品發布和增加管道廣度方面取得的重要進展感到高興。

On the commercial side, we recently signed a new agreement with the U.S. government for an initial 66 million doses for bivalent booster vaccine against Omicron. The agreement also includes options to purchase an additional 234 million doses, putting the total sales potentially up 400 million doses. The U.S. government has already exercised option for an additional 4 million doses since the contract was signed and announced. So the current total is actually 70 million doses contracted for the fall of 2022 with the U.S. government.

在商業方面，我們最近與美國政府簽署了一項新協議，針對 Omicron 的二價加強疫苗的初始劑量為 6600 萬劑。該協議還包括購買額外 2.34 億劑的選擇權，使總銷售額可能增加 4 億劑。自合同簽署和宣布以來，美國政府已經行使了額外 400 萬劑疫苗的選擇權。因此，目前的總量實際上是與美國政府在 2022 年秋季簽訂的 7000 萬劑合同。

In addition, both Canada and the U.K. had exercised options for their current agreements for additional deliveries in 2022.

此外，加拿大和英國都已就其當前協議在 2022 年進行額外交付行使了選擇權。

On the regulatory front, I am very happy to have Spikevax authorized for pediatric and adolescent population in the U.S. This (inaudible) efforts with regulatory clinical teams at Moderna and the U.S. FDA allows the protection of the young in the U.S. population as they head back to school.

在監管方面，我很高興 Spikevax 被授權用於美國的兒科和青少年群體。Moderna 和美國 FDA 的監管臨床團隊的這項（聽不清）努力允許在美國人口中的年輕人返回時保護他們去學校。

Health Canada and Australia have also authorized the use of vaccine for children 6 months to 5 years old.

加拿大衛生部和澳大利亞也已授權 6 個月至 5 歲的兒童使用疫苗。

Our research and clinical team continued the momentum in our pipeline. We have 4 programs in Phase III development with COVID bivalent booster, flu, RSV and CMV trials ongoing. Importantly, our Phase I study with mRNA-1020/1030 of 2 vaccines targeting the traditional flu antigen as well as the novel antigen is now fully enrolled. And our combination flu plus COVID vaccine is also fully enrolled for its Phase I/II. We look forward to this readout on safety and immunogenecity for our programs.

我們的研究和臨床團隊延續了我們管道的勢頭。我們有 4 個項目處於 III 期開發階段，正在進行 COVID 二價增強劑、流感、RSV 和 CMV 試驗。重要的是，我們針對傳統流感抗原和新型抗原的 2 種疫苗的 mRNA-1020/1030 的 I 期研究現已完全註冊。我們的流感加 COVID 聯合疫苗也已完全註冊其 I/II 期。我們期待著對我們項目的安全性和免疫原性的解讀。

In properties, we now have an open IND with our checkpoint vaccine in oncology, and we dosed our first patients with our GSDA1 rare disease program.

在屬性方面，我們現在有一個開放的 IND 與我們的腫瘤學檢查點疫苗，我們為我們的第一批患者接種了我們的 GSDA1 罕見病項目。

Finally, we are very pleased to be on track and look forward to sharing data for our proof-of-concept studies this year for 2 operative programs. The Phase I/II for a rare disease program, propionic acidemia or PA and our Phase II data with our personalized cancer vaccine in combination to KEYTRUDA versus KEYTRUDA monotherapy.

最後，我們很高興能夠走上正軌，並期待為我們今年的 2 個運營項目的概念驗證研究共享數據。用於罕見病項目、丙酸血症或 PA 的 I/II 期數據以及我們的個性化癌症疫苗與 KEYTRUDA 與 KEYTRUDA 單一療法相結合的 II 期數據。

Slide 6 is our usual snapshot of Moderna in August 2022, showing the breadth of the pipeline with 46 program development across vaccine but also therapeutics. The company has a strong foundation. We run a 3,400 teams and growing, 11 commercial subsidiary and a strong balance sheet with around $18 billion of cash to fuel our growth.

幻燈片 6 是我們通常在 2022 年 8 月對 Moderna 的快照，顯示了該管道的廣度，包括疫苗和治療藥物的 46 個項目開發。公司基礎雄厚。我們經營著 3,400 個團隊和不斷發展的 11 個商業子公司，以及擁有約 180 億美元現金的強勁資產負債表來推動我們的增長。

I will now hand it over to Paul.

我現在把它交給保羅。

Thank you, Stephane, and good day, everyone. As the COVID-19 pandemic continues and the SARS-CoV-2 virus keeps undergoing significant evolutionary change, the subject top of mind for many people is boosting, when to get boosted and what to get boosted with. In the next few slides, I want to show you how the Moderna mRNA-1273 vaccine is performing clinically in the booster setting and how antibody levels are performing in the real-world setting in individuals primed and boosted with mRNA vaccines.

謝謝你，斯蒂芬，大家好。隨著 COVID-19 大流行的持續和 SARS-CoV-2 病毒不斷發生重大的進化變化，許多人最關心的主題是加強、何時加強以及用什麼加強。在接下來的幾張幻燈片中，我想向您展示 Moderna mRNA-1273 疫苗在加強免疫環境中的臨床表現，以及在接受 mRNA 疫苗初免和加強免疫的個體中，抗體水平在現實世界中的表現如何。

Here in this next slide, you see the rates of COVID-19 infection in over 3 million individuals in a Spanish National Registry. The first point this data make is that boosting is highly effective, reducing the risk of infection. The second point the authors make is that mRNA-1273, the Moderna vaccine, is more effective than BNT162b2 and that the effect size increases over time.

在下一張幻燈片中，您可以看到西班牙國家登記處超過 300 萬人的 COVID-19 感染率。該數據提出的第一點是，加強是非常有效的，可以降低感染的風險。作者提出的第二點是，Moderna 疫苗 mRNA-1273 比 BNT162b2 更有效，並且效應大小會隨著時間的推移而增加。

In the second example, I'm showing you data from the U.S. VA system in over 450,000 individuals boosted with either mRNA-1273 shown here in green or BNT162b2 shown in red. Again, in terms of infection or hospitalization prevention, the authors conclude that mRNA-1273 is more effective than the alternate mRNA vaccine.

在第二個示例中，我向您展示了來自美國 VA 系統的數據，其中超過 450,000 人使用此處綠色顯示的 mRNA-1273 或紅色顯示的 BNT162b2 進行了增強。同樣，在感染或住院預防方面，作者得出結論，mRNA-1273 比替代 mRNA 疫苗更有效。

Finally, here are data from over 3 million individuals in the NHS England database, again, showing a clinically meaningful and statistically significant reduction in COVID-19 infection and hospitalization with mRNA-1273 boosting compared to BNT162b2 during the Omicron period of infection.

最後，這裡是來自 NHS England 數據庫中超過 300 萬個人的數據，再次顯示，在 Omicron 感染期間，與 BNT162b2 相比，mRNA-1273 增強的 COVID-19 感染和住院率顯著降低，具有臨床意義和統計學意義。

I want to turn now to data from an innovative, decentralized, pragmatic, real-world study we have recently conducted within the Moderna community, a collaborative platform with Evidation of over 100,000 participants here in the United States. The study is called disCOVEries, and it enrolled approximately 850 of these people into a real-world assessment of antibody levels, following primary vaccination and boosting with either Moderna-Moderna-Moderna, that's the MMM group, or Pfizer-Pfizer-Pfizer, that's the PPP group. Importantly, the study population has an average age of 44. Approximately 60% of the participants are female, and it's ethnically very diverse. Participants were enrolled into the study, consented and received a home self-administered microneedle blood collection kit from your buyer.

我現在想談談我們最近在 Moderna 社區內進行的一項創新、分散、務實的現實世界研究的數據，這是一個在美國擁有超過 100,000 名參與者的 Evidation 協作平台。這項研究被稱為發現，它招募了大約 850 名這些人進行抗體水平的真實評估，在初次接種疫苗並使用 Moderna-Moderna-Moderna（即 MMM 組）或 Pfizer-Pfizer-Pfizer（即PPP 組。重要的是，研究人群的平均年齡為 44 歲。大約 60% 的參與者是女性，而且種族非常多樣化。參與者被納入研究，同意並從您的買家那裡收到一個家庭自我管理的微針血液採集套件。

As you can see here across an array of SARS-CoV-2 variance of concern, higher and more durable antibody levels shown here on a logarithmic Y-axis scale were observed in those individuals primed and boosted with the Moderna vaccine in red relative to the Pfizer vaccine in blue from 8 weeks through 32 weeks following their first booster. Many of the comparisons were highly statistically significantly different. It's true, even for antibody levels against the Omicron BA.1 variant of concern, where an approximately 12-week duration advantage is seen in Moderna prime and boosted individuals compared to those receiving the Pfizer vaccine.

正如您在此處看到的一系列關注的 SARS-CoV-2 差異，在對數 Y 軸標度上顯示的這些個體中觀察到更高和更持久的抗體水平，相對於紅色的 Moderna 疫苗在第一次加強免疫後的 8 周到 32 週，輝瑞公司的藍色疫苗。許多比較在統計學上有很大差異。這是真的，即使是針對關注的 Omicron BA.1 變體的抗體水平，與接受輝瑞疫苗的人相比，Moderna Prime 和增強個體的持續時間優勢約為 12 週。

So taken together, these data demonstrate the strong performance of the Moderna vaccine in a real-world clinical boosting setting, which could be explained by higher enduring antibody levels against a wide variety of variants of concern.

綜上所述，這些數據證明了 Moderna 疫苗在現實世界的臨床加強環境中的強大性能，這可以通過針對各種關注變體的更高持久抗體水平來解釋。

I will now turn the call over to Dr. Stephen Hoge to provide comments regarding the composition of the 4 COVID-19 booster vaccines as well as other pipeline updates. Stephen?

我現在將把電話轉給 Stephen Hoge 博士，就 4 種 COVID-19 加強疫苗的組成以及其他管道更新提供意見。斯蒂芬?

Thank you, Paul. Good morning or good afternoon, everyone. I will quickly review some of the recent updates around our Omicron-containing COVID booster for the upcoming fall season, and then review the rest of our pipeline before handing it to Arpa.

謝謝你，保羅。大家早上好或下午好。我將在即將到來的秋季快速回顧我們包含 Omicron 的 COVID 助推器的一些最新更新，然後在將其交給 Arpa 之前回顧我們的其餘管道。

We are advancing 2 bivalent candidates for the fall/winter season of 2022 to meet different market demands. MRNA-1273.214 is our Omicron BA.1-containing bivalent vaccine. Clinical data previously presented from our Phase II/III study showed that 214 significantly increased neutralizing titers against BA.4, BA.5 compared to the currently authorized booster. Following regulatory discussions, we have submitted application for authorization for 214 in the EU, Australia, U.K., Canada and Switzerland. We have also started a rolling submission in Japan.

我們正在為 2022 年秋冬推出 2 款二價候選產品，以滿足不同的市場需求。 MRNA-1273.214 是我們的含有 Omicron BA.1 的二價疫苗。先前從我們的 II/III 期研究中提供的臨床數據顯示，與目前授權的加強劑相比，214 種針對 BA.4、BA.5 的中和滴度顯著增加。經過監管討論，我們已在歐盟、澳大利亞、英國、加拿大和瑞士提交了 214 的授權申請。我們還開始在日本滾動提交。

mRNA-1273.222 is our bivalent vaccine candidate that combines an Omicron-containing vaccine based on the BA.4, BA.5 subvariant and our original mRNA-1273. The FDA has asked us to submit for authorization for 222 based on the demonstrated strength of our bivalent platform against variants of concern, including data from our Phase II/III studies with 214 and 211 bivalent boosters. FDA has also advised manufacturers to initiate clinical trials with 222 as these data will serve useful as the pandemic continues to evolve. We expect to start this trial in August.

mRNA-1273.222 是我們的二價候選疫苗，它結合了基於 BA.4、BA.5 亞變體和我們原始 mRNA-1273 的含 Omicron 疫苗。 FDA 已要求我們根據我們的二價平台對關注變體的證明實力提交 222 的授權，包括我們使用 214 和 211 二價增強劑的 II / III 期研究的數據。 FDA 還建議製造商開始對 222 進行臨床試驗，因為隨著大流行的繼續發展，這些數據將很有用。我們預計將在 8 月開始這項試驗。

Now to review our respiratory vaccine pipeline on Slide 16. I just went over our Omicron-containing COVID boosters. We were happy to announce that our flu vaccine, mRNA-1010, launched an immunogenicity study in the Southern Hemisphere in June. And we are also preparing to launch an efficacy study for mRNA-1010 this upcoming fall, which will either serve as a post-approval efficacy study or, if we are not eligible for accelerated approval, will support our application. Our next-generation flu vaccines, which have 8 mRNAs across HA and NA antigens, our mRNA-1020 and 1030, also completed enrollment in their Phase I/II study. Our RSV program is ongoing, including a Phase III in older adults and a Phase I in pediatrics.

現在在幻燈片 16 上回顧我們的呼吸道疫苗管道。我剛剛回顧了我們的含有 Omicron 的 COVID 助推器。我們很高興地宣布，我們的流感疫苗 mRNA-1010 於 6 月在南半球啟動了一項免疫原性研究。我們還準備在即將到來的秋季啟動一項針對 mRNA-1010 的功效研究，這將作為批准後的功效研究，或者，如果我們沒有資格獲得加速批准，將支持我們的申請。我們的下一代流感疫苗（我們的 mRNA-1020 和 1030）含有 8 個跨 HA 和 NA 抗原的 mRNA，也完成了 I/II 期研究的註冊。我們的 RSV 計劃正在進行中，包括針對老年人的 III 期和兒科的 I 期。

Importantly, we also started and completed enrollment for the Phase I/II study of our COVID + flu vaccine this quarter. We look forward to sharing that data when we have it.

重要的是，我們還在本季度開始並完成了 COVID + 流感疫苗 I/II 期研究的註冊。我們期待在擁有這些數據時分享這些數據。

Our combination COVID + flu + RSV vaccine also expects to enter the clinic this year. Our endemic human coronavirus vaccine is in preclinical, along with our pediatric RSV + hMPV combination vaccine. And the pediatric hMPV + PIV3 vaccine Phase Ib is now fully enrolled.

我們的 COVID + 流感 + RSV 組合疫苗也有望在今年進入臨床。我們的地方性人類冠狀病毒疫苗與我們的兒科 RSV + hMPV 聯合疫苗一起處於臨床前階段。兒科 hMPV + PIV3 疫苗 Ib 期現已全面註冊。

Moving on to our latent and public health vaccine portfolio. our CMV vaccine is ongoing in a Phase III. Our EBV vaccine to prevent infectious mononucleosis is in a Phase I study. And our EBV vaccine to prevent long-term sequelae from the virus is in preclinical. We have 2 HIV Phase I trials and a Phase II Zika vaccine trial that are all ongoing. Our phase -- our HSV and VZV vaccines are in preclinical. And finally, we dosed the first participants in our Phase I study of our Nipah vaccine, which is being conducted in partnership with the NIH.

繼續我們的潛伏和公共衛生疫苗組合。我們的 CMV 疫苗正在進行第三階段。我們用於預防傳染性單核細胞增多症的 EBV 疫苗正在進行 I 期研究。我們用於預防病毒長期後遺症的 EBV 疫苗正處於臨床前階段。我們正在進行 2 項 HIV I 期試驗和一項 II 期寨卡疫苗試驗。我們的階段——我們的 HSV 和 VZV 疫苗處於臨床前階段。最後，我們在與 NIH 合作進行的 Nipah 疫苗 I 期研究中為第一批參與者接種了疫苗。

And to close on our therapeutics pipeline on Slide 18. Stephane already mentioned that we expect data from our proof-of-concept studies in our PCV and PA programs later this year. A few other important updates to highlight on this slide. First, we were happy to dose our first patient in our GSD1a trial and open an IND for our checkpoint cancer vaccine. Second, AstraZeneca notified us that after a portfolio review, they are returning the VEGF program and we are currently evaluating the next steps for that asset. Finally, based on a review of early clinical data from our IL-2 program for autoimmune disease and the evolving competitive landscape, we've decided to discontinue further development of our program and we'll remove it from our pipeline.

並在幻燈片 18 上結束我們的治療管道。 Stephane 已經提到，我們希望今年晚些時候在我們的 PCV 和 PA 項目中獲得我們的概念驗證研究的數據。在這張幻燈片上突出顯示的其他一些重要更新。首先，我們很高興在 GSD1a 試驗中為我們的第一位患者接種，並為我們的檢查點癌症疫苗開設了 IND。其次，阿斯利康通知我們，在對投資組合進行審查後，他們將返回 VEGF 項目，我們目前正在評估該資產的後續步驟。最後，基於對自身免疫性疾病 IL-2 項目早期臨床數據的審查和不斷變化的競爭格局，我們決定停止進一步開發我們的項目，並將其從我們的管道中刪除。

With that, I'll hand it over to Arpa.

有了這個，我會把它交給Arpa。

Thank you, Stephen. Good morning and good afternoon to everyone. As the newest member of Moderna's Executive Committee, I'm excited to see the impact that we've had in COVID as well as the commercial opportunities ahead for us in COVID as well as future vaccines and therapeutics in the long run leveraging our mRNA technology.

謝謝你，斯蒂芬。大家早上好，下午好。作為 Moderna 執行委員會的最新成員，我很高興看到我們在 COVID 方面產生的影響以及我們在 COVID 方面的商業機會，以及從長遠來看利用我們的 mRNA 技術的未來疫苗和療法.

Turning now to Slide 20, where you will see the regional sales mix in second quarter and in the first half of 2022. In the quarter, North American sales were $1.6 billion. These sales were driven by 1273 booster deliveries to the United States as we continue to fulfill our first U.S. government order, with the vast majority now delivered through the end of second quarter this year. In the quarter, we also delivered primary series doses for the pediatric group 5 years and younger as the authorization for this group came through in this quarter.

現在轉到幻燈片 20，您將在其中看到第二季度和 2022 年上半年的區域銷售組合。本季度，北美銷售額為 16 億美元。這些銷售是由向美國交付的 1273 台助推器推動的，因為我們繼續履行我們的第一個美國政府訂單，其中絕大多數現在交付到今年第二季度末。在本季度，我們還為 5 歲及以下的兒科組提供了主要係列劑量，因為該組的授權在本季度獲得通過。

Sales to EMEA were $1.5 billion, and sales to Asia Pacific were $1.1 billion. As you can see across the first 2 quarters of the year, North American sales were $2.7 billion, sales to EMEA were $3.9 billion and sales to Asia Pacific region were $3 billion. Of note, for both the 3- and 6-month periods, we saw a geographic diversification of sales across these key regions. This diversification is a reflection of how quickly we built out and executed within our global commercial organization.

對 EMEA 的銷售額為 15 億美元，對亞太地區的銷售額為 11 億美元。正如您在今年前兩個季度看到的那樣，北美銷售額為 27 億美元，歐洲、中東和非洲地區銷售額為 39 億美元，亞太地區銷售額為 30 億美元。值得注意的是，在 3 個月和 6 個月期間，我們看到這些關鍵地區的銷售地域多樣化。這種多元化反映了我們在全球商業組織中建立和執行的速度。

Now turning to Slide 21. We're also happy to see that as we continue to scale globally around the world that Spikevax's market share in the booster market, defined as a third or fourth booster dose, continues to show substantial market share.

現在轉到幻燈片 21。我們也很高興地看到，隨著我們繼續在全球範圍內擴大規模，Spikevax 在助推劑市場的市場份額（定義為第三或第四劑助推劑）繼續顯示出可觀的市場份額。

As Stephane has already mentioned, we see on Slide 22 our new U.S. government contracts for the fall of 2022. Specifically, the agreement initially was for 66 million doses of our bivalent COVID booster to be delivered in 2022. Earlier this week, the U.S. government informed us that they exercised an option for 4 million doses for the pediatric age group. This brings the total contract value to approximately $1.8 billion. Our U.S. government order includes options to purchase an additional 230 million doses, bringing the total to 300 million doses if all options are exercised. As you heard from Stephen earlier, as per FDA guidance, the U.S. fall booster product will be the mRNa-1273.222, which consists of 1273 and the Omicron BA.4/5 subvariant.

正如 Stephane 已經提到的，我們在幻燈片 22 上看到了我們在 2022 年秋季簽訂的新美國政府合同。具體來說，該協議最初是為了在 2022 年交付 6600 萬劑我們的二價 COVID 助推器。本週早些時候，美國政府通知我們，他們為兒科年齡組行使了 400 萬劑的選擇權。這使合同總價值達到約 18 億美元。我們的美國政府訂單包括購買額外 2.3 億劑疫苗的選擇權，如果所有選擇權都得到行使，總數將達到 3 億劑。正如您之前從 Stephen 那裡聽到的那樣，根據 FDA 的指導，美國的秋季助推器產品將是 mRNa-1273.222，它由 1273 和 Omicron BA.4/5 子變體組成。

I'd like to now spend some time on the evolution of the pandemic and the resulting impact on the commercial outlook. Early in the pandemic, we anticipated several factors, including the virus' evolution, population immunity at any given time and seasonal trends, would result in a shift to the endemic setting. And we've shared this illustrative graph before. These same factors have and will continue to influence the commercial outlook.

我現在想花一些時間來談談大流行的演變及其對商業前景的影響。在大流行初期，我們預計有幾個因素，包括病毒的進化、任何特定時間的人群免疫力和季節性趨勢，將導致向地方病環境轉變。我們之前已經分享過這個說明性圖表。這些相同的因素已經並將繼續影響商業前景。

With the emergence and then dominance of multiple variants at different time points, we have been able to develop boosters to address these variants, which includes our bivalent boosters against the Omicron variant. We are currently advancing 2 bivalent booster candidates for the fall of 2022 based on different market needs. The 2 bivalent booster candidates we're advancing are the mRNA-1273.214 and mRNa-1273.222. Both contain 25 micrograms of the currently authorized booster 1273 and 25 micrograms of an Omicron subvariant, either BA.1 or BA.4/5. Deliveries for these boosters will start in September this year and will be more heavily weighted to the fourth quarter as we ramp manufacturing and obtain regulatory authorizations around the world.

隨著多個變體在不同時間點的出現並占主導地位，我們已經能夠開發出解決這些變體的助推器，其中包括我們針對 Omicron 變體的二價助推器。根據不同的市場需求，我們目前正在為 2022 年秋季推出 2 種二價增強劑候選藥物。我們正在推進的 2 個二價增強候選藥物是 mRNA-1273.214 和 mRNA-1273.222。兩者都包含 25 微克當前授權的助推器 1273 和 25 微克 Omicron 子變體 BA.1 或 BA.4/5。這些助推器的交付將於今年 9 月開始，隨著我們在全球範圍內擴大生產並獲得監管授權，將更加重視到第四季度。

And to close, as we look to 2023, we are prepared for a shift to the commercial market in the U.S. for COVID boosters where the market will be more fragmented than it was during the pandemic where the U.S. government was the sole purchaser of vaccines. The commercial organization has already engaged with commercial payers and the channel, both channel distributors as well as key pharmacies, in anticipation of this shift. Internationally, we expect public health authorities to remain key purchasers of vaccines, but we are also identifying markets where there may be a private commercial market as well. All in all, we are well prepped for the transition as we have invested in building our commercial infrastructure, both in the U.S. and globally.

最後，展望 2023 年，我們已準備好轉向美國的 COVID 助推器商業市場，與大流行期間美國政府是疫苗的唯一購買者相比，市場將更加分散。商業組織已經與商業支付者和渠道（包括渠道分銷商和主要藥店）進行了接觸，以期待這種轉變。在國際上，我們預計公共衛生當局仍將是疫苗的主要購買者，但我們也在確定可能存在私人商業市場的市場。總而言之，我們已為轉型做好充分準備，因為我們已投資建設我們在美國和全球的商業基礎設施。

With that, I will turn it over to David.

有了這個，我會把它交給大衛。

Okay. Thank you, Arpa. Today, we're providing the analysis of actual 2022 second quarter results along with a view of key drivers of financial performance going forward. Overall, we continue to progress well, and I'm very pleased with our operational and commercial performance.

好的。謝謝你，阿帕。今天，我們將提供對 2022 年第二季度實際業績的分析，以及對未來財務業績的關鍵驅動因素的看法。總體而言，我們繼續取得良好進展，我對我們的運營和商業表現感到非常滿意。

Turning now to Slide 25, starting with an overview of our financial performance in the second quarter. Total product sales for the second quarter of 2022 of $4.5 billion increased by $334 million or 8% compared to the prior period. The total product sales growth in 2022 was primarily driven by higher average sale price of our COVID-19 vaccine due to changing customer mix. Total revenue was $4.7 billion for the second quarter of 2022, an increase of $395 million compared to Q2 of last year, driven by the increase of sales of our COVID-19 vaccine.

現在轉到幻燈片 25，首先概述我們第二季度的財務業績。 2022 年第二季度的產品總銷售額為 45 億美元，比上一季度增加了 3.34 億美元或 8%。 2022 年產品總銷售增長主要是由於客戶組合的變化導致我們 COVID-19 疫苗的平均銷售價格上漲。受我們 COVID-19 疫苗銷售額增長的推動，2022 年第二季度的總收入為 47 億美元，比去年第二季度增加了 3.95 億美元。

Cost of sales was $1.4 billion or 30% of product sales in the second quarter of 2022 compared to 18% of product sales for the same period in 2021. This includes a charge of $499 million for inventory write-downs related to excess and obsolete COVID-19 products, a loss on firm purchase commitments of $184 million and an expense for unutilized external manufacturing capacity of $131 million. These charges are driven by a substantial reduction of our expected deliveries to COVAX as indicated as a potential variable impacting our advanced purchase agreements in our last call and, to a lesser extent, by deferral of deliveries to other customers, particularly to the European Union in light of the expected upcoming launch of our updated bivalent vaccines.

2022 年第二季度的銷售成本為 14 億美元，佔產品銷售額的 30%，而 2021 年同期為 18%。這包括與過剩和過時的 COVID 相關的庫存減記費用 4.99 億美元-19 種產品，1.84 億美元的確定採購承諾損失和 1.31 億美元的未利用外部製造能力費用。這些費用是由於我們對 COVAX 的預期交付量大幅減少，這表明這是影響我們在上次電話會議中的預購協議的潛在變量，並且在較小程度上是由於推遲交付給其他客戶，特別是歐盟鑑於我們更新的二價疫苗預計即將推出。

Research and development expenses were $710 million for the second quarter of 2022, an increase by $289 million or 69% compared to the year ago period. The increase in R&D spend continues to be driven by clinical trial expenses, particularly with our COVID-19 and RSV programs as well as personnel-related costs for our expanding and maturing development portfolio.

2022年第二季度的研發費用為7.1億美元，同比增加2.89億美元或69%。研發支出的增長繼續受到臨床試驗費用的推動，特別是我們的 COVID-19 和 RSV 計劃以及我們不斷擴大和成熟的開發組合的人員相關成本。

Selling, general and administrative expenses were $211 million for the second quarter of 2022, increased by $90 million or 74% compared to the year ago period. The growth in spending was driven by the commercialization of our COVID-19 vaccine globally with continued investments in personnel and outside services in support of the accelerated company build-out.

2022 年第二季度的銷售、一般和管理費用為 2.11 億美元，與去年同期相比增加了 9,000 萬美元或 74%。支出的增長是由我們的 COVID-19 疫苗在全球的商業化推動的，並持續投資於人員和外部服務，以支持公司加速擴張。

The effective tax rate for the second quarter of 2022 was 11% compared to 9% for the same period in 2021. Let me remind you of the fact that we have a net operating loss carryforward of $2.3 billion at the end of 2020, which resulted in a nonrecurring benefit to the reported tax rate last year.

2022 年第二季度的有效稅率為 11%，而 2021 年同期為 9%。讓我提醒您一個事實，我們在 2020 年底有 23 億美元的淨營業虧損結轉，這導致去年報告的稅率的非經常性收益。

After-tax net income in Q2 2022 decreased by $583 million or 21% to $2.2 billion compared to the same period in 2021. The decrease was primarily due to higher cost of sales and other operating expenses in the current period.

與 2021 年同期相比，2022 年第二季度的稅後淨收入減少 5.83 億美元或 21%，至 22 億美元。減少的主要原因是當期銷售成本和其他運營費用增加。

Diluted EPS in Q2 2022 decreased by $1.22 or 19% to $5.24 a share, which is compared to the same period in 2021.

與 2021 年同期相比，2022 年第二季度攤薄後每股收益下降 1.22 美元或 19%，至每股 5.24 美元。

Turning now to year-to-date financial results compared to the prior year on Slide 26. Total product sales for the first 6 months of 2022 were $10.5 billion, increased by $4.5 billion or 76% compared to the prior year period. The total sales growth in 2022 was mainly attributable to our manufacturing capacity ramp-up and, to a smaller extent, to a favorable customer mix resulting in increased average selling price.

現在轉向幻燈片 26 上與去年相比的年初至今財務業績。2022 年前 6 個月的產品總銷售額為 105 億美元，與去年同期相比增加了 45 億美元或 76%。 2022年的總銷售額增長主要歸因於我們的製造能力提升，並在較小程度上歸因於有利的客戶組合導致平均售價增加。

Total revenue was $10.8 billion for the first 6 months of 2022 compared to $6.3 billion in the same period in 2021. The increase in total revenue was primarily driven by the increase of sales of our COVID-19 vaccine outside of the U.S.

2022 年前 6 個月的總收入為 108 億美元，而 2021 年同期為 63 億美元。總收入的增長主要是由於我們的 COVID-19 疫苗在美國以外的銷售額增加。

Cost of sales was $2.4 billion or 23% of product sales for the first 6 months of 2022. This compares to 16% of product sales in the prior year period on a reported basis or 19% adjusted for prelaunch inventory costs, which were expensed in 2020. The increase in cost of sales as a percent of product sales was mainly due to higher write-downs for excess and obsolete inventory expense and expenses related to future purchase commitments and unutilized external manufacturing capacity and, to a lesser extent, the lack of prelaunch inventory benefit that was realized in the first quarter of 2021.

2022 年前 6 個月的銷售成本為 24 億美元，佔產品銷售額的 23%。相比之下，在報告的基礎上，這一比例為去年同期產品銷售額的 16%，或根據發布前庫存成本調整後的 19%，這些成本在2020. 銷售成本佔產品銷售額的百分比上升主要是由於對過剩和過時的庫存費用以及與未來採購承諾和未利用的外部製造能力相關的費用的減記增加，在較小程度上是由於缺乏2021 年第一季度實現的發布前庫存收益。

Research and development expenses were $1.3 billion for the first 6 months of 2022, an increase of $442 million or 54% compared to the prior year. The increase in R&D spend continues to be driven by clinical trial expenses, personnel-related costs and outside services for expanding and maturing development portfolio including the development of our COVID-19 bivalent boosters.

2022年前6個月的研發費用為13億美元，比上年增加4.42億美元或54%。研發支出的增長繼續受到臨床試驗費用、人員相關成本和外部服務的推動，以擴大和成熟開發組合，包括開發我們的 COVID-19二價助推器。

Selling, general and administrative expenses of $479 million for the first 6 months of 2022 increased by $281 million or 142% compared to the year ago period. The growth in spending was driven by the commercialization of our COVID-19 vaccine globally and support of the accelerated company build-out, including substantial investments in digital. Additionally, in Q1 2022, there was an initial upfront endowment of $50 million for the newly established Moderna Foundation.

與去年同期相比，2022 年前 6 個月的銷售、一般和管理費用為 4.79 億美元，增加了 2.81 億美元或 142%。支出的增長是由我們的 COVID-19 疫苗在全球的商業化和對加速公司建設的支持（包括對數字領域的大量投資）推動的。此外，在 2022 年第一季度，新成立的 Moderna 基金會獲得了 5000 萬美元的初始預付款。

The effective tax rate for the first 6 months was 13% compared to 7% for the same period in 2021. The increase was primarily due to the benefit recorded in 2021 related to the release of the valuation allowance on the majority of our deferred tax assets.

前 6 個月的有效稅率為 13%，而 2021 年同期為 7%。增加的主要原因是 2021 年記錄的與釋放我們大部分遞延所得稅資產的估值備抵有關的收益.

After-tax net income increased by $1.9 billion or 46% to $5.9 billion for the first 6 months of 2022 compared to the same period in 2021. The increase in net income was driven by the growth of our product sales.

與 2021 年同期相比，2022 年前 6 個月的稅後淨收入增加了 19 億美元或 46%，達到 59 億美元。淨收入的增長是由我們的產品銷售增長推動的。

Diluted EPS for the first 6 months of 2022 increased by $4.55 or 49% to $13.85 compared with the same period in 2021.

與 2021 年同期相比，2022 年前 6 個月的稀釋後每股收益增加了 4.55 美元或 49% 至 13.85 美元。

Turning now to cash and cash deposits on Slide 27. We ended Q2 2022 with cash and investments of $18.1 billion compared to $19.3 billion at the end of Q1 of this year. The decrease reflects the share repurchase activities in Q2 of $1.3 billion. The ending balance of cash deposits for future product supply was $4.1 billion compared to $5.3 billion at the end of the previous quarter. The reduction quarter-over-quarter is driven by product deliveries against customer deposits.

現在轉向幻燈片 27 上的現金和現金存款。截至 2022 年第二季度，我們的現金和投資為 181 億美元，而今年第一季度末為 193 億美元。減少反映了第二季度 13 億美元的股票回購活動。用於未來產品供應的現金存款期末餘額為 41 億美元，而上一季度末為 53 億美元。季度環比減少是由產品交付與客戶存款驅動的。

Now turning to Slide 28. Our capital allocation priorities remain unchanged. Our top investment priority has been and will continue to be reinvesting in the base business across multiple areas. As previously stated, R&D spending was $1.3 billion in the first half of 2022, a 54% increase on a year-over-year basis. We remain on track with our full year R&D forecast of $2.5 billion to $3 billion.

現在轉到幻燈片 28。我們的資本配置優先事項保持不變。我們的首要投資重點一直是並將繼續在多個領域對基礎業務進行再投資。如前所述，2022 年上半年的研發支出為 13 億美元，同比增長 54%。我們的全年研發預測仍保持在 25 億至 30 億美元的軌道上。

Our second investment priority is to seek attractive external investment and collaboration opportunities to further expand the reach of Moderna's technology and capabilities. We are considering attractive opportunities that enable and complement our platform and take a disciplined approach in evaluating potential outside investments. We're in multiple active discussions regarding additional external collaboration opportunities.

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，以進一步擴大 Moderna 的技術和能力範圍。我們正在考慮具有吸引力的機會，以支持和補充我們的平台，並採取嚴格的方法評估潛在的外部投資。我們正在就額外的外部合作機會進行多次積極討論。

After evaluating internal and external investment opportunities, we then assess additional uses of cash. In the second quarter of 2022, we repurchased 9 million shares for $1.3 billion. Since inception of our repurchase activities last year up until August 2, we have purchased 18 million shares or approximately 4% of our outstanding diluted shares for $3 billion in total.

在評估內部和外部投資機會後，我們會評估現金的其他用途。 2022 年第二季度，我們以 13 億美元回購了 900 萬股股票。自去年開始回購活動以來，截至 8 月 2 日，我們已購買 1800 萬股或約 4% 的已發行攤薄股份，總計 30 億美元。

As a reminder, we announced a share repurchase program for $3 billion in February of this year and currently have approximately $1 billion of remaining capacity from that authorization. As part of today's press release, we announced that the Board has authorized an additional share buyback program of $3 billion with no expiry.

提醒一下，我們在今年 2 月宣布了一項 30 億美元的股票回購計劃，目前該授權的剩餘產能約為 10 億美元。作為今天新聞稿的一部分，我們宣布董事會已授權一項額外的 30 億美元股票回購計劃，且不會到期。

Now let's turn to our 2022 updated financial framework on Page 29. We continue to have signed advanced purchase agreements for expected delivery in 2022 in the amount of approximately $21 billion. This includes expected sales from the recently announced new agreement with the U.S. government. And an adjustment for doses that remain unallocated by COVAX due to lack of demand, we indicated this was a possibility on our last call.

現在讓我們轉到第 29 頁上更新的 2022 年財務框架。我們繼續簽署預購協議，預計在 2022 年交付，金額約為 210 億美元。這包括最近宣布的與美國政府達成的新協議的預期銷售額。由於缺乏需求，對 COVAX 仍未分配的劑量進行了調整，我們在上次電話會議上表示這是可能的。

Furthermore, this total includes expected negative foreign exchange impacts compared to the contract value at signing, which we estimate to be approximately 1.5% of sales for the full year 2022, assuming current rates remain through year-end. We anticipate that for sales in the second half of 2022, sales will be greater in the fourth quarter than the third quarter driven by the timing of anticipated approval of our updated COVID-19 vaccines and the related manufacturing ramp-up of the new products.

此外，與簽約時的合同價值相比，這一總數包括預期的負面外匯影響，我們估計這約為 2022 年全年銷售額的 1.5%，假設當前利率保持到年底。我們預計，由於我們更新的 COVID-19 疫苗的預期批准時間和新產品的相關生產增加，第四季度的銷售額將高於第三季度的銷售額。

Our total cost of sales includes the cost of goods manufacturer, third-party royalties as well as logistics and warehousing costs. We now expect our full year 2022 reported cost of sales to be in the mid-20% range, driven by the previously mentioned costs related to a reduction of doses to COVAX and deferral of doses to other customers. Cost of sales could increase to the high 20 percentage range in the event of further charges due to product updates.

我們的總銷售成本包括商品製造商成本、第三方特許權使用費以及物流和倉儲成本。我們現在預計我們 2022 年全年報告的銷售成本將在 20% 的中間範圍內，這是由前面提到的與減少 COVAX 劑量和推遲給其他客戶的劑量相關的成本推動的。如果由於產品更新而進一步收費，銷售成本可能會增加到 20% 的高位。

For R&D and SG&A, we continue to expect full year expenses to be approximately $4 billion, driven by our maturing development portfolio and the global scaleup of the company. Based on current tax laws, we now expect our 2022 effective tax rate to be in the low to mid-teen range as a result of the benefits from the foreign-derived intangible income driven by our international business mix as well as stock-based compensation reductions.

對於研發和 SG&A，我們繼續預計全年支出約為 40 億美元，這主要得益於我們成熟的開發組合和公司的全球擴張。根據現行稅法，我們現在預計我們 2022 年的有效稅率將在低至青少年範圍內，這是由於我們的國際業務組合驅動的外國無形收入以及基於股票的薪酬帶來的好處減少。

Finally, regarding capital expenditures, we continue to plan for capital expenditures in the range of $0.6 billion to $0.8 billion as we further build out our manufacturing and general company infrastructure globally.

最後，在資本支出方面，隨著我們進一步在全球範圍內建設製造和一般公司基礎設施，我們將繼續規劃 6 億至 8 億美元的資本支出。

This concludes my remarks concerning the financial performance, and I turn the call back over to Stephane.

我對財務業績的評論到此結束，我將電話轉回給斯蒂芬。

Thank you, David, Arpa, Stephen and Paul, for those updates.

感謝 David、Arpa、Stephen 和 Paul 的更新。

In 2022, we set out to execute on 5 key priorities: First, to execute on delivering vaccine against $21 billion of signed advanced purchase agreement. With half of the year behind us and the signed deals for the fall of 2022 and our strong manufacturing team, we are on target.

2022 年，我們著手執行 5 個關鍵優先事項：首先，根據已簽署的 210 億美元預購協議執行疫苗交付。我們已經過去了半年，2022 年秋季簽署的交易以及我們強大的製造團隊，我們正朝著目標前進。

We have continued the momentum in our late-stage clinical trials with our Phase III trials now in flu, RSV and CMV, and I thank our team for delivering on such aggressive time lines.

我們在流感、RSV 和 CMV 的 III 期試驗中繼續了後期臨床試驗的勢頭，我感謝我們的團隊在如此積極的時間線上交付。

We are on track to share data from proof-of-concept studies from 2 therapeutic applications of our technology with data for our PA and PCV trial in second half. We have continued to make progress with new development candidates in vaccine and therapeutics. Some have already been announced and more will come in the second half of the year.

我們有望在下半年與我們的 PA 和 PCV 試驗的數據共享我們技術的 2 個治療應用的概念驗證研究數據。我們在疫苗和治療的新開發候選藥物方面繼續取得進展。一些已經宣布，更多將在今年下半年推出。

And finally, the recent announcement of our inhaled LNP with our partner Vertex, we've expanded our mRNA platform to target preliminary disease.

最後，我們最近與合作夥伴 Vertex 宣布了我們的吸入 LNP，我們已經擴展了我們的 mRNA 平台以針對初步疾病。

As we grow, we are committed to doing the right things in the right way for patients and our stakeholders. As a company led by a founding team, we are thinking in 5-, 10-, 20-year increments.

隨著我們的成長，我們致力於以正確的方式為患者和我們的利益相關者做正確的事情。作為一家由創始團隊領導的公司，我們以 5 年、10 年、20 年為增量進行思考。

To that end, this year, we'll publish our very first ESG report, which highlights the key pillars of our corporate responsibility framework, medicine for patients, our employees, the environment, our community and, of course, governance. I'm proud of what we are doing initially at this pillar and so proud of the ambitious goals we set for ourselves. I believe that the first steps to achieving those ambitious goal is to set them, to create and foster a purpose-driven culture and governance framework to meet those goals.

為此，今年，我們將發布我們的第一份 ESG 報告，其中強調了我們企業責任框架的關鍵支柱、為患者提供的藥物、我們的員工、環境、我們的社區，當然還有治理。我為我們最初在這個支柱上所做的事情感到自豪，也為我們為自己設定的雄心勃勃的目標感到自豪。我相信，實現這些雄心勃勃的目標的第一步是設定它們，創建和培育以目標為導向的文化和治理框架，以實現這些目標。

As an example, our goal of a net zero carbon emission globally by 2030, we put Moderna among the global leaders in promoting long-term sustainable growth for our planet and our organization. We will share more detail on our ESG journey at our ESG Day on November 10. But first, we look forward to hosting you at our Annual Day of September 8.

例如，我們的目標是到 2030 年在全球實現淨零碳排放，我們將 Moderna 列為促進地球和組織長期可持續增長的全球領導者。我們將在 11 月 10 日的 ESG 日分享更多關於 ESG 旅程的詳細信息。但首先，我們期待在 9 月 8 日的年度日接待您。

Moderna's mission to deliver on the promise of mRNA science to create a new generation of transformative medicine for patients has always been our North Star. Despite the challenges in the financial market with concern on inflation and ensuing increase in interest rates and the cost of capital, Moderna is in a very fortunate position.

Moderna 的使命是兌現 mRNA 科學的承諾，為患者創造新一代的變革性藥物，這一直是我們的北極星。儘管金融市場面臨通貨膨脹以及隨之而來的利率和資本成本上升的挑戰，但 Moderna 處於非常幸運的位置。

We have a unique mRNA platform, enabling the generation at unprecedented speed of innovative medicine. We have a strong team of 3,400 mission-driven employees. We have $18 billion of cash on our balance sheet and with a strong commercial momentum. We have no intention of slowing down our growth. We are putting our head down and doing the work. I have never been as excited about the future of Moderna. Now is not the time to slow down, patients are waiting for innovative medicine.

我們擁有獨特的 mRNA 平台，能夠以前所未有的速度產生創新藥物。我們擁有一支由 3,400 名任務驅動型員工組成的強大團隊。我們的資產負債表上有 180 億美元的現金，而且商業勢頭強勁。我們無意放慢我們的增長速度。我們正在低頭做這項工作。我從未對 Moderna 的未來感到如此興奮。現在不是放慢腳步的時候，患者正在等待創新藥物。

Thank you for listening, and now we'll be happy to take questions. Operator?

感謝您的收聽，現在我們很樂意回答問題。操作員？

(Operator Instructions) Our first question comes from Matthew (inaudible).

（操作員說明）我們的第一個問題來自 Matthew（聽不清）。

Great. Stephane, I was hoping you could just maybe address in a little bit more specificity how you're thinking about opportunities for either acquisitions or collaborations. I think it's a topic that comes up a lot among investors, and I think there's a different scope that a lot of people think about including the things that are quite large versus things which might be more complementary on the technology side to the platform. So if you could just address how you're thinking about that in your priorities, that would be great.

偉大的。 Stephane，我希望你能更具體地談談你是如何考慮收購或合作的機會的。我認為這是一個在投資者中經常出現的話題，而且我認為很多人考慮的範圍不同，包括相當大的事物與可能在技術方面與平台更具互補性的事物。因此，如果您可以在優先事項中解決您的想法，那就太好了。

Sure. Thanks for the question, Matthew. So as you know, we have [rated] now for over a year, our capital allocation strategy, that's in a cash flow positive situation. Priority number one, invest in the business; two, external investment to build the company; and three, share buyback.

當然。謝謝你的問題，馬修。如您所知，我們已經 [評級] 一年多了，我們的資本配置策略處於現金流正的情況。第一要務，投資業務；二、對外投資建設公司；三是股票回購。

As you have seen through what we have done over the last quarters, we have been, I think, totally aligned with this strategy in terms of investment in internal R&D. As David said, a 69% increase in R&D investments Q2 this year versus Q2 last year. As you've seen with the announcement of actually our third share buyback plan today, also being very aggressive there.

正如您所看到的，我們在過去幾個季度所做的工作，我認為，在內部研發投資方面，我們完全符合這一戰略。正如大衛所說，今年第二季度的研發投資比去年第二季度增長了 69%。正如您在我們今天宣布的第三次股票回購計劃中所看到的那樣，在那裡也非常積極。

As you see, we have done a few deals in the last year in our external collaborations. We have not acquired any company at this stage. We see this, to your point, as how do we expand the potential of the company to deliver on its mission to make innovative medicine?

如您所見，去年我們在外部合作中完成了一些交易。我們現階段沒有收購任何公司。在您看來，我們認為，我們如何擴大公司的潛力以實現其製造創新藥物的使命？

And on external front, I think there's always 2 filters that are important for us, is finding interesting assets and finding them at a price that we think we can create value for. As we've said and David confirmed today, our busy teams are extremely busy looking at a lot of things. But as you know, it's a bit the same as investors are looking for companies who invest. We need to look at a lot of things before we decide to go for something.

在外部方面，我認為總有兩個過濾器對我們很重要，即尋找有趣的資產並以我們認為可以創造價值的價格找到它們。正如我們所說和大衛今天證實的那樣，我們忙碌的團隊正忙著處理很多事情。但如你所知，這有點像投資者正在尋找投資的公司。在我們決定做某事之前，我們需要看很多東西。

We won't be shy if we find great assets. There's a lot of assets that are very early. There's lot of assets that don't really fit the company's strategy. We'll keep looking. I think doing a large acquisition for the sake of large acquisition is not our strategy. What we want to do is to be the best nucleic acid company in the world. As we've said, we'll be very happy to go outside mRNA as long as we stay to the nucleic acid space. We'll be happy to do acquisition. If we find good assets, we'd be happy to do partnerships. An acquisition is not a goal in itself. So that's a bit how we think about outside investment, Matthew.

如果我們找到偉大的資產，我們不會害羞。有很多資產非常早期。有很多資產並不真正符合公司的戰略。我們會繼續尋找。我認為為大收購而大收購不是我們的策略。我們要做的是做世界上最好的核酸公司。正如我們所說，只要我們留在核酸空間，我們就會非常樂意走出 mRNA。我們很樂意進行收購。如果我們找到好的資產，我們很樂意建立合作夥伴關係。收購本身並不是一個目標。這就是我們對外部投資的看法，馬修。

Our next question comes from Elizabeth Webster with Goldman Sachs.

我們的下一個問題來自高盛的伊麗莎白韋伯斯特。

This is Elizabeth on for Salveen. Congrats on the quarter. Could you walk us through the path to authorization for 1273.222 and just clarify exactly what the path is here. And then when could we see data from the trials you mentioned that are starting this month?

這是伊麗莎白在薩爾文。祝賀本季度。您能否引導我們完成 1273.222 的授權路徑，並明確說明此處的路徑是什麼。那麼我們什麼時候才能看到你提到的本月開始的試驗的數據？

And then our second question is, if you had to think of levers for potential upside to the $21 billion in APAs, where might those come from? And could additional new orders come online?

然後我們的第二個問題是，如果你必須考慮到 210 億美元的 APA 潛在上行空間的槓桿，這些可能來自哪裡？還會有更多的新訂單上線嗎？

Thank you for the question. I'll take the first one, and I assume to pass to Arpa for the second. So first on the 222, this is a bivalent vaccine that is based on the BA.4, BA.5 variant, this is most -- I think the question is directed mostly to the FDA guidance and the focus, particularly in the United States, on authorization of that vaccine. We continue to work hard to pull together, both preclinical and manufacturing data and all of our underlying bivalent platform data, which includes 2 different Phase II/III studies that I referenced, the mRNA-1273.211 and mRNa-1273.214, both of which demonstrated superiority of the bivalent platform and the performance against Omicron variant of concern.

感謝你的提問。我會拿第一個，我假設第二個傳給 Arpa。所以首先是 222，這是一種基於 BA.4、BA.5 變體的二價疫苗，這是最多的——我認為問題主要針對 FDA 的指導和重點，特別是在美國，根據該疫苗的授權。我們將繼續努力整合臨床前和製造數據以及我們所有基礎的二價平台數據，其中包括我引用的 2 個不同的 II/III 期研究，mRNA-1273.211 和 mRNA-1273.214，這兩個研究都顯示出優越性二價平台的性能和關注的 Omicron 變體的性能。

So the totality of that data, those 2 Phase II/III studies plus preclinical data and manufacturing data will form the submission, which is consistent with the published FDA guidance. FDA has also asked us, as you referenced, to run an additional study really to support future deployment because we do want to understand the performance of the 222 vaccine, if there's further variant evolution, for instance, in December or January. It has unfortunately happened every year in this pandemic. And we want to have samples that allows us to inform that sorts of decisions about deployment of the vaccine.

因此，這些數據的整體，這 2 項 II/III 期研究加上臨床前數據和製造數據將構成提交，這與已發布的 FDA 指南一致。正如您所提到的，FDA 還要求我們進行一項額外的研究，以真正支持未來的部署，因為我們確實想了解 222 疫苗的性能，如果有進一步的變種進化，例如，在 12 月或 1 月。不幸的是，這種流行病每年都會發生。我們希望獲得樣本，使我們能夠為有關疫苗部署的各種決策提供信息。

We expect to enroll that study really in August, but the data wouldn't be available for a few months because you would follow until approximately a month to get the boosted samples, collect them and then test them in the relevant assays. We do not, at this point, expect nor the FDA has suggested that, that data would be required prior to authorization. In fact, we will be authorizing, based on the prior clinical data for 211, 214, the preclinical data and manufacturing data. But we will have that -- those samples in hand.

我們希望真正在 8 月註冊該研究，但數據要幾個月才能獲得，因為您要等到大約一個月才能獲得增強樣本，收集它們，然後在相關分析中對其進行測試。在這一點上，我們不期望 FDA 也沒有建議在授權之前需要這些數據。事實上，我們將根據 211、214 的先前臨床數據，對臨床前數據和製造數據進行授權。但是我們將擁有這些樣本。

Now as to the specific timing of when we would be able to share 222 data other than later in the fall, I don't think we have any other specific items today, except to emphasize again that it's really not required for the authorization based on recent FDA guidance. It really is to support future deployment decisions that are in the later part of winter.

至於具體什麼時候可以共享222數據的具體時間，除了秋季晚些時候，我認為我們今天沒有其他具體的項目，只是再次強調一下，基於授權確實不需要最近的 FDA 指南。它確實是為了支持冬季後期的未來部署決策。

And then I can take that second question on the $21 billion guidance. From an advanced purchase agreement perspective, we do believe the majority of the market demand is captured in this $21 billion. That being said, we continue to work with countries around the world on potential additional orders for our bivalent vaccines as many countries are continuing to assess their public health needs as well as their booster population recommendations and considering potential expansions to those populations. So we're feeling pretty good about the $21 billion, but we do continue to work with countries to see if and when there is additional demand for either the 214 or the 222 bivalent vaccine.

然後我可以回答關於 210 億美元指導的第二個問題。從預先購買協議的角度來看，我們相信大部分市場需求都在這 210 億美元中。話雖如此，我們將繼續與世界各國就我們的二價疫苗的潛在額外訂單進行合作，因為許多國家正在繼續評估其公共衛生需求以及加強人口的建議，並考慮擴大這些人口的潛在規模。因此，我們對 210 億美元感到非常滿意，但我們確實繼續與各國合作，看看是否以及何時對 214 或 222 二價疫苗有額外需求。

Our next question comes from Michael Yee with Jefferies.

我們的下一個問題來自 Jefferies 的 Michael Yee。

A quick question in relates to the comments around getting the BA.4/5 222 authorized. Stephen, you had mentioned the pathway there. But I actually wanted to think a little bit forward. Do you envision that future variants and development vaccines would be able to be authorized quickly via just preclinical data such as like flu? Do you think that, that's where the path is going and that the FDA seems to be going along that route? That's the first question.

一個簡短的問題涉及有關獲得 BA.4/5 222 授權的評論。斯蒂芬，你提到了那裡的路徑。但我實際上想向前思考一點。您是否設想未來的變種和開發疫苗能夠僅通過流感等臨床前數據快速獲得授權？您是否認為，這就是道路的發展方向，而 FDA 似乎正在沿著這條道路前進？這是第一個問題。

And then second question, just ironically you had made comments around monkeypox vaccine. And now WHO has made comments around global health emergency. So I didn't see any update there and wondering if that actually had made any progress.

然後是第二個問題，具有諷刺意味的是，您曾就猴痘疫苗發表過評論。現在，世衛組織已經就全球衛生緊急情況發表了評論。所以我在那裡沒有看到任何更新，我想知道這是否真的取得了任何進展。

Sure. Thank you for the question, Michael. I'll try and take both. So first on the approach, I think you're right. We do believe that the flu model for authorization of strain settlements, strain updates every year will make sense in the future for COVID vaccines and boosters. And in that sense, the authorization of 222, if the FDA -- if that does happen with the FDA and other markets follow, it really becomes the first instance of that.

當然。謝謝你的問題，邁克爾。我會嘗試兩者兼得。所以首先在方法上，我認為你是對的。我們確實相信，用於授權菌株定居、每年進行菌株更新的流感模型將在未來對 COVID 疫苗和增強劑有意義。從這個意義上說，222 的授權，如果 FDA - 如果這確實發生在 FDA 和其他市場之後，它真的成為第一個例子。

We are still going to have to file for a supplemental BLA instantiating that, pulling together from that framework. But we are actively working with regulators, not just in the U.S. but globally to try and establish that pathway. Because at the end of the day, in order for us to take full advantage of the platform and respond every year, it makes sense that we don't conduct clinical studies before authorization in the future.

我們仍然需要申請一個補充的 BLA 來實例化它，從那個框架中拉出來。但我們正在積極與監管機構合作，不僅在美國，而且在全球範圍內嘗試建立這條途徑。因為歸根結底，為了讓我們充分利用平台並每年做出回應，我們將來在授權之前不進行臨床研究是有道理的。

We also think that the flu model and the performance of the platform globally, now in billions of people, really does start to demonstrate the potential for us to mature to more of an endemic approach that doesn't require a clinical study every time.

我們還認為，流感模型和平台在全球範圍內的表現，現在有數十億人，確實開始證明我們有潛力成熟為一種不需要每次都進行臨床研究的地方性方法。

So that is our expectation and hope. We'll obviously engage with regulators over the fall and winter as we complete those filings and try and prepare for 2023 that might look just like that. And again, I think that 222 experience this fall really might just be that first instance of what becomes the new norm.

這就是我們的期待和希望。我們顯然會在秋季和冬季與監管機構接觸，因為我們完成了這些文件並嘗試為可能看起來像這樣的 2023 年做準備。再說一次，我認為今年秋天的 222 次體驗真的可能只是成為新規範的第一個例子。

Now on monkeypox, we did initiate a research program. We are tracking that very closely. And obviously, given the recent public health announcements and increasing concern about availability of vaccine supply, we have been beginning to look at what it would take for us to use our platform to provide a monkeypox vaccine, both intervene in the current epidemic, but also to try and address long-term issues of supply in this public health threat.

現在關於猴痘，我們確實啟動了一項研究計劃。我們正在密切跟踪這一點。顯然，鑑於最近的公共衛生公告和對疫苗供應可用性的日益關注，我們已經開始考慮使用我們的平台提供猴痘疫苗需要什麼，既干預當前的流行病，又試圖解決這一公共衛生威脅中的長期供應問題。

We do not have any updates on those discussions. We will firm them up. Those will include, if appropriate, some regulatory consultations. And once we have clarity on whether we are moving to clinical development and what that path would be, we'll, of course, provide an update on it. But at this stage, it remains a preclinical program, but one that we're tracking very closely given the recent developments.

我們沒有關於這些討論的任何更新。我們將堅定他們。這些將包括，如果合適的話，一些監管諮詢。一旦我們明確我們是否正在轉向臨床開發以及這條道路將是什麼，我們當然會提供更新。但在現階段，它仍然是一個臨床前項目，但鑑於最近的發展，我們正在密切關注這一項目。

Next question comes from Gena Wang on Barclays.

下一個問題來自巴克萊銀行的 Gena Wang。

This is [Sheldon] on for Gena. Congrats on the good quarter. We have two questions. One is on the current APA for 2022. Could you comment on how much -- how many doses for the COVAX contracts are still unallocated and how they were accounted for in the current $21 billion guidance? And could you also remind us on the current APA for 2023? And how should we think about the demand next year?

這是吉娜的[謝爾頓]。祝賀好季度。我們有兩個問題。一個是關於 2022 年當前的 APA。您能否評論一下 COVAX 合同中有多少劑量仍未分配，以及它們在當前 210 億美元的指導中是如何計算的？您能否提醒我們當前的 2023 年 APA？我們應該如何看待明年的需求？

And a quick follow-up, another question on mRNA-1010 flu vaccine, the Phase III immunogenicity trial. How do you think about the expected data time line? Do you need to enroll also in the Northern Hemisphere?

快速跟進，關於 mRNA-1010 流感疫苗的另一個問題，即 III 期免疫原性試驗。您如何看待預期的數據時間線？您是否也需要在北半球註冊？

Maybe I'll take the last question first. And Arpa, do you want to take...

也許我會先回答最後一個問題。還有阿帕，你想帶...

Yes. Sure. We'll take it in order. So just to reiterate, the $21 billion in advanced purchase agreement does not include any additional COVAX doses to be allocated. So that already reflects a lower demand that we're seeing from the COVAX countries. And we anticipate that for the remainder of the year, we'll see very few additional orders and/or demands from these countries.

是的。當然。我們會按順序處理的。因此，重申一下，210 億美元的預購協議不包括任何額外的 COVAX 劑量分配。因此，這已經反映了我們從 COVAX 國家看到的較低需求。我們預計，在今年剩下的時間裡，我們將很少看到來自這些國家的額外訂單和/或需求。

In terms of 2023 orders, we have already signed deals with 5 countries that we've previously announced, the United Kingdom, Canada, Australia, Kuwait and Taiwan. We have also signed options with Canada, Switzerland, Taiwan as well. And we are actively having dialogue with countries around the world for additional orders in 2023. We will be able to provide additional guidance on what these advanced purchase orders look like later this year or early next year.

在 2023 年訂單方面，我們已經與我們之前宣布的 5 個國家簽署了協議，即英國、加拿大、澳大利亞、科威特和台灣。我們還與加拿大、瑞士、台灣簽署了期權協議。我們正在積極與世界各國就 2023 年的額外訂單進行對話。我們將能夠在今年晚些時候或明年初就這些高級採購訂單的樣子提供額外的指導。

Great. And then on the question of the flu Phase III study that's ongoing, so that is a Southern Hemisphere immunogenicity and safety study. As we said, we're moving -- that study is ongoing. We haven't characterized where we are. The -- we do not expect at this point that we would need to rotate that study into the Northern Hemisphere, so we'll be concluding that safety immunogenicity study enrolling in the Southern Hemisphere.

偉大的。然後關於正在進行的流感 III 期研究的問題，這是一項南半球免疫原性和安全性研究。正如我們所說，我們正在移動——這項研究正在進行中。我們還沒有描述我們在哪裡。 - 我們目前不認為我們需要將該研究輪換到北半球，因此我們將得出在南半球註冊的安全免疫原性研究的結論。

We do expect to run a Phase III efficacy study in the Northern Hemisphere in the later part of this year. And so we will be studying Northern Hemisphere comparators this year, but not the current ongoing Phase III, that is the safety immunogenicity study that we believe could support accelerated approval.

我們確實希望在今年下半年在北半球進行一項 III 期療效研究。因此，我們今年將研究北半球比較器，但不是目前正在進行的第三階段，即我們認為可以支持加速批准的安全免疫原性研究。

So just a follow-up, of the Southern Hemisphere immunogenicity data, so likely data will be available later in 2022.

因此，這只是南半球免疫原性數據的後續行動，因此很可能數據將在 2022 年晚些時候提供。

So we haven't specifically guided on when the data will be available. But generally, as you know, those safety immunogenicity studies after they enroll follow non-inferiority or superiority endpoints at day 29, so 1 month after [booster]. And so the data will follow shortly once we've completed enrollment. But ultimately, we will also want to follow up with safety data and consult with regulators about their expectations of what sort of follow-up data they would like to see. And so until we've had all of those consultations, we won't specifically guide on timing.

所以我們沒有具體指導數據何時可用。但一般來說，如您所知，這些安全性免疫原性研究在註冊後遵循非劣效或優勢終點在第 29 天，即 [助推器] 後 1 個月。因此，一旦我們完成註冊，數據很快就會出現。但最終，我們還希望跟進安全數據，並與監管機構協商他們希望看到什麼樣的後續數據的期望。因此，在我們進行所有這些磋商之前，我們不會具體指導時間安排。

Our next question comes from Tyler Van Buren with Cowen.

我們的下一個問題來自 Tyler Van Buren 和 Cowen。

This is Tara on for Tyler. So I was hoping you could provide some comments on the 11% share gain that Pfizer was referring to since January 1 and where that might be coming from. Like is most of it coming from the adeno vaccine given the share that they have lost? And of course, I'd be interested to know where the Spikevax share changes are coming from as well.

這是泰勒的塔拉。所以我希望你能就輝瑞公司自 1 月 1 日以來提到的 11% 的份額增長以及這可能來自何處提供一些評論。考慮到他們失去的份額，大部分來自腺疫苗嗎？當然，我也很想知道 Spikevax 份額變化的來源。

Sure. I can take that question. In terms of the share, the shares that we reported today are looking at the cumulative share for Spikevax across just the third and fourth boosters, which is a difference compared to some of the data that Pfizer has shared and also looked at the major markets, the OECD markets that we play in. So as we think about the majority of where our source of business is coming from, we're seeing substantial market share holds and, in some cases, even some market share gains year-to-date. Again, focusing just on the booster population, which is where the vast majority of our current and future growth is coming from.

當然。我可以接受這個問題。就份額而言，我們今天報告的份額正在查看 Spikevax 在第三和第四個助推器中的累積份額，這與輝瑞分享的一些數據以及主要市場的數據相比有所不同，我們參與的經合組織市場。因此，當我們考慮我們的大部分業務來源時，我們看到大量市場份額保持不變，在某些情況下，甚至一些市場份額今年迄今有所增長。同樣，只關注助推器人群，這是我們當前和未來增長的絕大部分來源。

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

我們的下一個問題來自美國銀行的 Geoffrey Meacham。

On Slide 23, you guys gave sort of an illustrative example of kind of the longer-term opportunity for COVID. I want to just get, as you invest in '23 and beyond, not asking for guidance, but how do you think about what would be the tail of the endemic phase in terms of either volume or patients, et cetera?

在幻燈片 23 上，你們舉了一個說明性的例子來說明 COVID 的長期機會。當您在 23 年及以後進行投資時，我只想得到，而不是尋求指導，但是您如何看待流行階段的尾部在數量或患者等方面會是什麼？

And then a related question in terms of capital allocation, how do you guys think about investing in business? As I know, Stephane, the goal here is to further expand the reach of Moderna's technology in one of your slides. But how do you think about adding capabilities that are outside of that, that may be peripheral, but I wasn't sure how far you're willing to sort of steer a little bit away from the core mRNA.

然後是資本配置方面的一個相關問題，你們如何看待投資商業？據我所知，Stephane，這裡的目標是在您的一張幻燈片中進一步擴展 Moderna 的技術範圍。但是您如何考慮添加超出此範圍的功能，這可能是外圍的，但我不確定您是否願意稍微遠離核心 mRNA。

Okay. So I think maybe, Arpa, you and I will tag team on the first question and then come to Stephane on the M&A one.

好的。所以我想也許，Arpa，你和我會在第一個問題上標記團隊，然後在 M&A 問題上找 Stephane。

So first maybe on the morbidity of the disease in that picture, we do believe that endemic human coronaviruses point a picture here would suggest there's going to be seasonal disease. There will unfortunately be breakthrough infection, some hospitalization, even some death. And that will happen indefinitely, particularly in those that are higher risk. The question, how we define that higher risk is 65 plus, 50 plus or is it 18 plus with high risk factors, or is it broadly, will really depend upon the evolution of the virus. It's hard to anticipate. But we do believe over time, this will become a seasonal market where boosting and elevating neutralizing protection to prevent breakthrough infections will happen annually in a large population, and they will benefit from it, just like they do for flu or they would for endemic human coronaviruses.

因此，首先可能是關於該圖片中疾病的發病率，我們確實認為地方性人類冠狀病毒指向這裡的圖片表明將出現季節性疾病。不幸的是會有突破性感染，一些住院，甚至一些死亡。這將無限期地發生，特別是在那些風險較高的地區。問題是，我們如何定義更高的風險是 65 歲以上、50 歲以上，或者是 18 歲以上的高風險因素，還是廣義上的，這將真正取決於病毒的演變。很難預料。但我們確實相信，隨著時間的推移，這將成為一個季節性市場，每年都會在大量人群中加強和提升中和保護以防止突破性感染，他們將從中受益，就像他們對流感或地方性人類所做的那樣冠狀病毒。

Arpa, I don't know if you want to comment on how that market evolves.

Arpa，我不知道您是否想評論該市場的發展方式。

So the only comment I would add to that is we will continue to work closely with (inaudible) as well as governments around the world to see how their recommendations evolve for their populations in terms of the populations that are being covered and how often they're recommending booster. So we'll continue to work with them and over time see how the demand shapes up.

因此，我要補充的唯一評論是，我們將繼續與（聽不清）以及世界各地的政府密切合作，看看他們的建議如何根據所覆蓋的人口以及他們的頻率如何演變為他們的人口。重新推薦助推器。所以我們將繼續與他們合作，隨著時間的推移，看看需求是如何形成的。

Thanks, guys. And on the capital allocation, as I've shared in the past, we are very interested by playing with information molecules, so nucleic acid. And so we're not only looking at mRNA to express human protein, as you know. We are also looking at mRNA through gene editing. As you know, we've already done some partnership there and we look forward to giving you some updates in the near future.

多謝你們。關於資本配置，正如我過去分享的那樣，我們對玩信息分子非常感興趣，所以核酸。因此，如您所知，我們不僅在研究表達人類蛋白質的 mRNA。我們也在通過基因編輯來研究 mRNA。如您所知，我們已經在那裡建立了一些合作夥伴關係，我們期待在不久的將來為您提供一些更新。

But then also in the gene therapy, we talked about RNA also being potential space of interest. So I think really depending at nucleic acid, I think as we've shared in the past, going to a small molecule or large molecule is not something that we think will build the best version of Moderna, again, taking a 3-, 5-, 10-year view of things. I think there's a lot of things we can do in terms of nucleic acid. And we like the ability to plug and play on to the platform across research, across development, across CMC. So there's really true benefit and synergies versus just getting the product for the sake of getting a product and driving more complexity into the company and getting into technologies that we see have little in common with nucleic acids.

但同樣在基因治療中，我們談到 RNA 也是潛在的關注空間。所以我認為真的取決於核酸，我認為就像我們過去分享的那樣，使用小分子或大分子並不是我們認為會構建最好的 Moderna 版本的東西，再次，採用 3-, 5 -，10年的事情觀。我認為我們可以在核酸方面做很多事情。我們喜歡跨研究、跨開發、跨 CMC 即插即用平台的能力。因此，與僅僅為了獲得產品而獲得產品並為公司帶來更多複雜性並進入我們認為與核酸幾乎沒有共同之處的技術相比，確實有真正的好處和協同作用。

Our last question comes from Ellie Merle with UBS.

我們的最後一個問題來自瑞銀的 Ellie Merle。

Just as you think about the pipeline and capital allocation from here, can you help us think about just with the buybacks as well as further business development, how you're thinking about prioritization.

正如您從這裡考慮管道和資本分配一樣，您能否幫助我們考慮僅通過回購以及進一步的業務發展，您如何考慮優先級。

And then just a second question on monkeypox. Just I know that since you've announced that you have been looking at it preclinically and given the kind of public health emergency and broader vaccine needs, can you comment a bit your plans from here and any further plans for development?

然後是關於猴痘的第二個問題。只是我知道，既然你已經宣布你一直在臨床前研究它，並且考慮到公共衛生緊急情況和更廣泛的疫苗需求，你能從這裡評論一下你的計劃和任何進一步的開發計劃嗎？

So let me start on capital allocation, this is Stephane. As David illustrated on one of our slides that we have been using for a few quarters now, our priority #1 stays in investing in the business. We are really excited about the platform that we have.

所以讓我從資本配置開始，這是斯蒂芬。正如大衛在我們已經使用了幾個季度的一張幻燈片中所說明的那樣，我們的首要任務是投資於業務。我們對我們擁有的平台感到非常興奮。

As you know, in vaccine, given the vaccine modality has been derisked, we are willing to invest pretty aggressively. It's kind of remarkable that we already have 4 vaccines in Phase III right now. And as we shared on the last call, we have shown now 3x the ability to go from starting a clinical study in vaccine to starting a Phase III in around 12 months' time frame, which I think really speak about the platform of CMC capabilities and, of course, how we really build a very strong late-stage development team.

如您所知，在疫苗方面，鑑於疫苗模式已被取消，我們願意進行相當積極的投資。令人驚訝的是，我們現在已經有 4 種疫苗處於 III 期。正如我們在上次電話會議上分享的那樣，我們現在已經展示了在大約 12 個月的時間框架內從開始疫苗臨床研究到開始 III 期臨床研究的能力提高了 3 倍，我認為這真正說明了 CMC 能力的平台和當然，我們如何真正建立一個非常強大的後期開發團隊。

So the thing that's going to be interesting, of course, is the human proof-of-concept that we talked about coming later this year in cancer and in rare disease because if 1 of those 2 or both of those 2 were to work in terms of getting interesting clinical signal, you will most probably see us do what we did with vaccine, which is expand very quickly. As you know, one of the really good things about messenger RNA and how we build the company with a lot of robotics, a lot of digitalization is the ability to scale very quickly.

因此，有趣的是，當然，我們談到的人類概念驗證將在今年晚些時候在癌症和罕見疾病中出現，因為如果這兩個中的一個或這兩個都起作用在獲得有趣的臨床信號時，您很可能會看到我們正在做我們對疫苗所做的事情，疫苗的擴張速度非常快。如您所知，信使 RNA 以及我們如何用大量機器人技術建立公司的真正好處之一是快速擴展的能力。

We already start in new applications like rare disease or cancer before we know if the technology is working. We kind of plan to start P&L with only a few programs. But if, let's say, we have a positive readout in PA, will you see us developing many more programs than what we have now in rare disease very quickly? The answer is yes. And we see something in oncology.

在我們知道這項技術是否有效之前，我們已經開始研究罕見疾病或癌症等新應用。我們計劃只用幾個程序來啟動損益表。但是，假設我們在 PA 中有一個積極的讀數，你會看到我們很快開發出比現在在罕見病方面更多的項目嗎？答案是肯定的。我們在腫瘤學中看到了一些東西。

So investing in the business is priority #1. Priority #2 is really expanding the platform through partnership, licensing, M&A and then the excess cash that we will return to shareholders. And I think the announcement of a third buyback plan today with a new $3 billion authorization by the Board is a confirmation of the ability to return the capital if we cannot find good use in the company. Stephen, do you want to say about the monkeypox?

因此，投資業務是第一要務。優先事項 #2 是通過合作、許可、併購以及我們將返還給股東的多餘現金來真正擴展平台。而且我認為今天宣布董事會新授權的 30 億美元的第三次回購計劃是對如果我們無法在公司中找到良好用途的情況下返還資本的能力的確認。斯蒂芬，你想談談猴痘嗎？

Yes, yes. So look, I think conceptually, we're obviously very aware of the monkeypox concern and obviously very sensitive to recent announcements. And so what we are looking to do is understand if we were to develop that program, how would we move it? The purpose of moving it would be to move very quickly.

是的是的。所以看，我認為從概念上講，我們顯然非常了解猴痘問題，並且顯然對最近的公告非常敏感。因此，我們要做的是了解如果我們要開發該程序，我們將如何移動它？移動它的目的是快速移動。

As Stephane just covered, our platform is pretty well established. And our ability to rapidly scale is -- has been demonstrated. And if we were to go after a monkeypox clinical development program, it would be to very quickly progress towards an approvable set of endpoints in a clinical study. And in that sense, we need to engage with regulators and other consultations to determine what that path would be. It's not primary or principal interest for us to just advance the program and demonstrate in Phase I clinical immunogenicity, we would really be doing it to try and help generate a public health countermeasure.

正如 Stephane 剛剛介紹的那樣，我們的平台非常完善。我們快速擴展的能力已經得到證明。如果我們要進行猴痘臨床開發計劃，那將是在臨床研究中迅速朝著一組可批准的終點邁進。從這個意義上說，我們需要與監管機構和其他磋商進行接觸，以確定這條道路將是什麼。僅僅推進該計劃並在 I 期臨床免疫原性中展示並不是我們的主要或主要利益，我們真的會這樣做以嘗試並幫助制定公共衛生對策。

And so those conversations, we will start and we'll engage with them. We obviously also recognize. There are other even larger public health threats right now. COVID remains a larger public health threat, and many regulators are totally focused on addressing the updated booster work for this fall. And so we're respectful of that. But we will engage in those conversations. And once we have clarity on whether or not we will go forward, given what we think those endpoints will be, we'll obviously provide it. But at this point, it's premature to say more because we have not clarified those endpoints and therefore have not made our own decision about whether we will move the preclinical program into clinical development at this stage.

因此，我們將開始這些對話，並與他們互動。我們顯然也認可。現在還有其他更大的公共衛生威脅。 COVID 仍然是一個更大的公共衛生威脅，許多監管機構完全專注於解決今年秋季更新的助推器工作。所以我們對此表示尊重。但我們將參與這些對話。一旦我們明確我們是否會繼續前進，考慮到我們認為這些端點將是什麼，我們顯然會提供它。但在這一點上，說更多還為時過早，因為我們還沒有澄清這些終點，因此我們還沒有決定是否將在這個階段將臨床前項目轉移到臨床開發中。

Well, thank you so much, everybody, for joining the call today for your questions. We look forward to speaking to many of you and look forward to welcoming you at our R&D Day early September. Have a great day. Thank you.

好吧，非常感謝大家今天加入電話會議以提出您的問題。我們期待與你們中的許多人交談，並期待在 9 月初的研發日歡迎你們。祝你有美好的一天。謝謝你。

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，度過美好的一天。