莫德納 (MRNA) 2021 Q2 法說會逐字稿

Good morning, and welcome to Moderna's Second Quarter Earnings Call.

早上好，歡迎參加 Moderna 第二季度財報電話會議。

(Operator Instructions) Please be advised that the call is being recorded.

（操作員說明）請注意，通話正在錄音。

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

現在，我想將電話轉給 Moderna 投資者關係主管 Lavina Talukdar。

Please proceed.

請繼續。

Thank you, operator.

謝謝你，接線員。

Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's Second Quarter 2021 Financial Results and Business Update.

大家早上好，感謝您參加今天的電話會議，討論 Moderna 2021 年第二季度財務業績和業務更新。

You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website.

您可以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; David Meline, our Chief Financial Officer; Stephen Hoge, our President; Paul Burton, our Chief Medical Officer; Corinne Le Goff, our Chief Commercial Officer; and Jackie Miller, our Senior Vice President, Therapeutic Head of Infectious Diseases.

我們的首席執行官 Stéphane Bancel 出席了今天的電話會議； David Meline，我們的首席財務官；斯蒂芬·霍格，我們的總裁； Paul Burton，我們的首席醫療官； Corinne Le Goff，我們的首席商務官；以及我們的高級副總裁兼傳染病治療主管 Jackie Miller。

Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of Private Litigations Reform Act of 1995.

在我們開始之前，請注意，本次電話會議將包括根據 1995 年私人訴訟改革法案的安全港條款做出的前瞻性陳述。

Please see Slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our performance and results to differ materially from those expressed or implied in these forward-looking statements.

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，了解可能導致我們的業績和結果與這些前瞻性聲明中明示或暗示的結果存在重大差異的重要風險因素。

On Slide 3, please see the important indication and information for our COVID-19 vaccine, which has been authorized for emergency use in the United States and in many countries around the world.

在幻燈片 3 上，請查看我們的 COVID-19 疫苗的重要適應症和信息，該疫苗已被授權在美國和世界許多國家緊急使用。

I will now turn the call over to Stéphane.

我現在將把電話轉給 Stéphane。

Thank you, Lavina.

謝謝你，拉維娜。

Good morning or good afternoon, everyone.

大家早上好或者下午好。

Welcome to our Q2 2021 conference call.

歡迎參加我們的 2021 年第二季度電話會議。

Today, I will start by a quick business review of our quarter before Corinne walks you through the commercial update.

今天，我將首先對本季度的業務進行快速回顧，然後 Corinne 將向您介紹商業更新。

David will present the key financials.

大衛將介紹主要財務數據。

Stephen and Jackie will provide the clinical update highlighting new human data about the final analysis for COVID-19 vaccine Phase III COVE study and human data for COVID-19 booster candidate Phase II.

Stephen 和 Jackie 將提供臨床更新，重點介紹有關 COVID-19 疫苗 III 期 COVE 研究最終分析的新人體數據以及 COVID-19 加強候選疫苗 II 期的人體數據。

I will then come back to close to share some thoughts about where we are heading.

然後我將返回來分享一些關於我們前進方向的想法。

Let me start with Moderna COVID-19 or Spikevax.

讓我從 Moderna COVID-19 或 Spikevax 開始。

We are pleased to announce today that our final analysis vaccine efficacy of the Phase III COVE study is holding very nicely at 93%.

我們今天很高興地宣布，我們對 III 期 COVE 研究的最終分析疫苗功效保持在 93%。

We are starting to get authorizations for adolescent indication 12 to 17 years of age, receiving authorization in Japan this week and the positive recommendation from the European Medicines Agency in July.

我們開始獲得針對 12 至 17 歲青少年適應症的授權，本週在日本獲得授權，並於 7 月份獲得歐洲藥品管理局的積極推薦。

An important step towards our vision of an annual respiratory combination booster is the start of a Phase I/II for mRNA-1010, which is a quadrivalent seasonal flu vaccine.

mRNA-1010（一種四價季節性流感疫苗）的 I/II 期啟動是實現我們年度呼吸道聯合加強疫苗願景的重要一步。

Our teams are already preparing the Phase II/III for this program.

我們的團隊已經在為該計劃的第二/第三階段做準備。

We were delighted to get Fast Track Designation from the U.S. FDA for our RSV vaccine candidate, mRNA-1345, in adults over 60 years of age.

我們很高興獲得美國 FDA 對我們的 RSV 候選疫苗 mRNA-1345 針對 60 歲以上成人的快速通道指定。

There is no approved RSV vaccine.

目前還沒有批准的 RSV 疫苗。

The burden for RSV infection is very high.

RSV 感染的負擔非常高。

In adults over 65 years of age, according to the CDC, 177,000 of hospitalizations and around 14,000 deaths occur annually in the U.S. due to RSV.

據 CDC 統計，在美國，每年有 177,000 例 65 歲以上成年人因 RSV 住院治療，約 14,000 例死亡。

Our teams are also preparing a Phase II/III for this program.

我們的團隊還正在為該計劃準備第二/第三階段。

Our Zika vaccine has now moved to Phase II.

我們的寨卡疫苗現已進入第二階段。

mRNA-3927 for propionic acidemia, or PA, a rare genetic disease, has also started dosing patients in our Phase I/II.

用於治療丙酸血症（PA）（一種罕見的遺傳性疾病）的 mRNA-3927 也已開始在我們的 I/II 期患者中給藥。

And we are pleased to announce recently that we started dosing healthy volunteers in our first autoimmune disease program, mRNA-6231, coding for IL-2.

我們很高興地宣布，最近我們開始在第一個自身免疫性疾病項目 mRNA-6231（編碼 IL-2）中對健康志願者進行給藥。

So Moderna is now in the clinic in 5 large therapeutic areas: infectious diseases, cancer, cardiology, autoimmune disease and rare genetics diseases.

所以Moderna現在在5大治療領域進入臨床：傳染病、癌症、心髒病、自身免疫性疾病和罕見遺傳病。

We have a strong pipeline momentum, and the research teams are working hard to bring the next wave of development candidates to the clinic.

我們擁有強大的研發勢頭，研究團隊正在努力將下一波開發候選藥物引入臨床。

Moving to Slide 6. We have also a strong commercial momentum.

轉向幻燈片 6。我們也有強勁的商業勢頭。

Let me start by giving you an update about Advanced Purchase Agreements, or APA, for our COVID-19 vaccine, Spikevax.

首先，我向您介紹有關我們的 COVID-19 疫苗 Spikevax 的提前購買協議 (APA) 的最新信息。

For fiscal year 2021, we have now signed APAs for $20 billion versus $19.2 billion announced in our Q1 call.

對於 2021 財年，我們現已簽署了 200 億美元的預約定價安排，而第一季度電話會議中宣布的金額為 192 億美元。

We are now capacity constrained for 2021, and we are not taking any more orders for 2021 delivery.

目前，我們 2021 年的產能有限，並且不再接受 2021 年交付的訂單。

For fiscal year 2022, we have already signed APAs for $12 billion.

2022 財年，我們已經簽署了 120 億美元的預約定價安排。

We have also signed an additional $8 billion in options.

我們還額外簽署了 80 億美元的期權。

We are having numerous discussions ongoing as we speak with countries around the world to enter into new APAs for 2022.

當我們與世界各國就 2022 年新的預約定價安排進行談判時，我們正在進行大量討論。

We'll continue to give you updates on a regular basis.

我們將繼續定期為您提供更新信息。

What is very interesting to see is that forward-thinking countries, like Israel and Switzerland, have already signed APAs for 2023 to ensure supply for the endemic market.

非常有趣的是，以色列和瑞士等具有前瞻性的國家已經簽署了 2023 年的 APA，以確保流行市場的供應。

On the financial front, we delivered $4.4 billion of revenue and $2.8 billion of net income.

在財務方面，我們實現了 44 億美元的收入和 28 億美元的淨利潤。

The cash generation in the quarter was strong at around $4 billion, bringing our cash balance to over $12 billion at the end of June.

本季度現金生成強勁，約為 40 億美元，使我們的現金餘額在 6 月底超過 120 億美元。

We're also announcing today our first share buyback plan.

我們今天還宣布了我們的第一個股票回購計劃。

Our Board of Directors has authorized a share repurchase for up to $1 billion.

我們的董事會已授權回購最多 10 億美元的股票。

David and I will give you more color in a few minutes.

大衛和我將在幾分鐘內為您提供更多信息。

For 2021, we continue to forecast supply between 800 million and 1 billion doses.

2021 年，我們繼續預測供應量在 8 億至 10 億劑之間。

For 2022, we forecast supply between 2 billion to 3 billion doses, depending on the final dose approved by the regulators for our booster: at 50 micrograms up to 3 billion doses, at 100 micrograms up to 2 billion.

到 2022 年，我們預計供應量為 20 億至 30 億劑，具體取決於監管機構批准的加強劑最終劑量：50 微克至 30 億劑，100 微克至 20 億劑。

As we continue focusing on scaling the company, I am delighted to have 3 new executive committee members who joined recently.

隨著我們繼續專注於擴大公司規模，我很高興最近有 3 名新的執行委員會成員加入。

By start date at the company: Shannon Klinger as our Chief Legal Officer and Corporate Secretary.

截至公司任職日期：Shannon Klinger 擔任我們的首席法務官兼公司秘書。

She joined us from Novartis, where she was the Chief Legal Officer.

她在加入我們之前曾在諾華擔任首席法務官。

Mr. Paul Burton, our Chief Medical Officer, he joined us from Janssen Pharmaceuticals, a Johnson & Johnson company, where he was Chief Global Medical Affair Officer.

Paul Burton 先生是我們的首席醫療官，加入我們之前曾在強生公司旗下楊森製藥公司擔任首席全球醫療事務官。

And most recently, Kate Cronin has our newly created role of Chief Brand Officer.

最近，凱特·克羅寧 (Kate Cronin) 擔任我們新設立的首席品牌官一職。

Kate was, until recently, the CEO of Ogilvy Health.

凱特直到最近才擔任奧美健康公司的首席執行官。

I look forward to working closely with Shannon, Paul and Kate as we scale Moderna to the next level.

我期待著與 Shannon、Paul 和 Kate 密切合作，將 Moderna 提升到新的水平。

On Slide 9, you will find our usual summary slide.

在幻燈片 9 上，您會找到我們常用的摘要幻燈片。

A few important things to note.

需要注意的一些重要事項。

We are now preparing Phase II/III for quadrivalent seasonal flu and our RSV program.

我們現在正在為四價季節性流感和 RSV 計劃準備第二/第三階段。

Our team continues to grow as we increase manufacturing capacity for COVID-19 vaccine as we move programs from early-stage clinical study to late-stage clinical studies, and as we increase investment in research for the next wave of development candidates.

隨著我們將項目從早期臨床研究轉向後期臨床研究，以及增加對下一波開發候選藥物的研究投資，我們提高了 COVID-19 疫苗的生產能力，我們的團隊不斷壯大。

Let me now turn to Corinne to give you a commercial update.

現在讓我請 Corinne 為您提供商業更新。

Corinne?

科琳娜？

Thank you, Stéphane, and good morning or good afternoon, everyone.

謝謝你，Stéphane，大家早上好或下午好。

I am happy to share the productive quarter the commercial organization has had in the second quarter that continues into today, as we ramp up our efforts to supply the Moderna COVID-19 vaccine, or Spikevax, to countries around the world.

我很高興與大家分享該商業組織在第二季度持續到今天的富有成效的季度，因為我們加大了向世界各國供應 Moderna COVID-19 疫苗（或 Spikevax）的努力。

Let me start by recapping the Advanced Purchase Agreements that we have signed for delivery in 2021 on Slide 11.

讓我首先回顧一下我們在幻燈片 11 上簽署的將於 2021 年交付的預購協議。

Since the last quarterly call, I am very happy to highlight that we have signed APAs with COVAX for 34 million doses this year; an additional 110 million doses to the USG, bringing the total of doses for the United States to about 400 million doses; and 10 million doses to Australia for delivery in 2021.

自上次季度電話會議以來，我非常高興地強調，今年我們已與 COVAX 簽署了 3400 萬劑 APA；向美國政府額外提供 1.1 億劑疫苗，使美國的疫苗總量達到約 4 億劑；並於 2021 年向澳大利亞運送 1000 萬劑疫苗。

In total, we anticipate up to $20 billion in sales from these agreements as we deliver against them throughout the remainder of the year.

總的來說，我們預計這些協議的銷售額將在今年剩餘時間內達到 200 億美元。

We are proud to distribute our vaccine directly or through our network of partners across all continents and, most importantly, to ensure access to our vaccines to all countries regardless of their income level, notably through the COVAX facility structure.

我們很自豪能夠直接或通過我們遍布各大洲的合作夥伴網絡分發我們的疫苗，最重要的是，確保所有國家無論其收入水平如何都能獲得我們的疫苗，特別是通過 COVAX 設施結構。

I also want to mention that we are doing our utmost to -- in supporting the U.S. government to execute the donations of Moderna doses of vaccines.

我還想提一下，我們正在盡最大努力支持美國政府捐贈 Moderna 劑量的疫苗。

Slide 12 list outs signed APAs for deliveries in 2022 and even in 2023.

幻燈片 12 列出了 2022 年甚至 2023 年交付的已簽署 APA。

The construct of the APAs signed for '22 and '23 include both confirmed orders as well as options to be triggered at a future date.

'22 和 '23 簽署的 APA 的結構包括已確認的訂單以及在未來日期觸發的選項。

To date, we have already contracted for 22 product sales of $12 billion and an additional $8 billion in options.

迄今為止，我們已經簽訂了 22 種產品銷售合同，價值 120 億美元，另外還有 80 億美元的期權。

Some of these APAs are for primary series vaccines, and others are for potential boosters.

其中一些 APA 用於初級系列疫苗，另一些則用於潛在的加強疫苗。

In light of the possibility of needing booster vaccines to increase immune responses against waning immunity and the emergence of variants of concern, Moderna has already started our COVID booster strategy that Stephen will speak to shortly.

鑑於可能需要加強疫苗來增強免疫反應，以應對免疫力下降和令人擔憂的變種的出現，Moderna 已經啟動了我們的新冠加強疫苗戰略，斯蒂芬很快將談到這一戰略。

In the meantime, the commercial team is currently engaged in multiple conversations that are gaining urgency as we watch the Delta variant surge among unvaccinated populations.

與此同時，商業團隊目前正在進行多項對話，隨著我們看到 Delta 變種在未接種疫苗的人群中激增，這些對話變得越來越緊迫。

We are notably actively talking to many countries in South America, in Asia and in the Middle East.

值得注意的是，我們正在與南美洲、亞洲和中東的許多國家積極對話。

All these countries are keenly interested in securing both primary series vaccines or booster vaccines for their citizens next year.

所有這些國家都非常有興趣明年為其公民獲得初級系列疫苗或加強疫苗。

In the United States, as you know, Moderna has initiated the rolling submission process for BLA approval and expects to complete its submission in August.

如您所知，在美國，Moderna 已啟動 BLA 批准的滾動提交流程，預計將於 8 月完成提交。

This approval will represent an important milestone in achieving herd immunity as it might help combat vaccine hesitancy.

這一批准將成為實現群體免疫的一個重要里程碑，因為它可能有助於消除疫苗猶豫不決的情況。

It will also allow the commercial organization to start preparing for the private U.S. market.

它還將使商業組織開始為美國私人市場做準備。

Turning to Slide 13, which reviews the sales breakout for the second quarter '21.

轉向幻燈片 13，其中回顧了 21 年第二季度的銷售突破。

Total product sales in the quarter were $4.2 billion, representing 199 million doses delivered in the quarter.

該季度的產品總銷售額為 42 億美元，相當於該季度交付的劑量為 1.99 億劑。

Sales in the U.S. were $2.1 billion, representing 126 million doses delivered to the U.S. government.

美國的銷售額為 21 億美元，相當於向美國政府交付了 1.26 億劑疫苗。

And sales to the rest of the world -- to the countries that are listed on this slide, were also $2.1 billion, representing 73 million doses delivered in the quarter.

向世界其他地區（本幻燈片中列出的國家/地區）的銷售額也達到 21 億美元，相當於本季度交付的 7300 萬劑疫苗。

And with that, let me hand it over to David to take you through the financial details.

接下來，讓我把它交給大衛，讓他帶你了解財務細節。

Okay.

好的。

Thank you, Corinne.

謝謝你，科琳娜。

We're providing today the analysis of actual 2021 second quarter results, along with an updated view of key drivers of financial performance going forward.

我們今天提供 2021 年第二季度實際業績分析，以及未來財務業績關鍵驅動因素的最新觀點。

As in previous quarters, we are presenting our results primarily on a U.S. GAAP basis.

與前幾個季度一樣，我們主要根據美國公認會計原則（U.S. GAAP）公佈業績。

In some cases, we also provide additional detail to provide greater clarity on underlying trends.

在某些情況下，我們還會提供更多詳細信息，以便更清楚地了解潛在趨勢。

Turn now please to Slide 15.

現在請翻到幻燈片 15。

The transformation of Moderna from an R&D-focused biotech to a commercial company is very apparent when reviewing our financial results.

當回顧我們的財務業績時，Moderna 從一家專注於研發的生物技術公司向商業公司的轉變是非常明顯的。

The comparison of the second quarter of 2021 to prior year is not as meaningful due to our dynamic growth, which is why we'll primarily focus on the quarter-over-quarter comparison relative to Q1 on this slide.

由於我們的動態增長，2021 年第二季度與上一年的比較沒有那麼有意義，這就是為什麼我們在這張幻燈片上主要關注相對於第一季度的季度環比比較。

Total revenue was $4.4 billion in the second quarter of 2021 compared to $1.9 billion in Q1.

2021 年第二季度的總收入為 44 億美元，而第一季度的總收入為 19 億美元。

The increase of total revenue is primarily resulting from the sale of the company's COVID-19 vaccine.

總收入的增加主要來自該公司COVID-19疫苗的銷售。

Product sales in Q2 were $4.2 billion compared to $1.7 billion in the first quarter, an increase of 142%.

第二季度產品銷售額為 42 億美元，較第一季度的 17 億美元增長 142%。

Cost of sales were $750 million or 18% of the company's product sales in the second quarter compared to $193 million in the first quarter.

第二季度銷售成本為 7.5 億美元，占公司產品銷售額的 18%，而第一季度為 1.93 億美元。

Research and development expenses were $421 million in Q2 2021 compared to $401 million in Q1 and $152 million in the same period in 2020.

2021 年第二季度的研發費用為 4.21 億美元，而第一季度為 4.01 億美元，2020 年同期為 1.52 億美元。

The higher spend versus prior quarter and prior year was driven by increased COVID-19 vaccine clinical development activities, including our announced efforts around booster, variant-specific and multivalent vaccine candidates.

與上一季度和上一年相比，支出增加的原因是 COVID-19 疫苗臨床開發活動的增加，包括我們宣布的圍繞加強疫苗、變體特異性疫苗和多價候選疫苗的努力。

Selling, general and administrative expenses were $121 million for Q2 compared to $77 million for the prior quarter.

第二季度的銷售、一般和管理費用為 1.21 億美元，而上一季度的銷售、一般和管理費用為 7700 萬美元。

The growth in spending was driven by commercialization of our COVID-19 vaccine globally with the biggest increases being in personnel and outside services.

支出的增長是由我們的 COVID-19 疫苗在全球的商業化推動的，其中增幅最大的是人員和外部服務。

Provision for income taxes was $283 million in Q2 after $39 million in Q1 and an insignificant amount in the prior year.

第二季度所得稅撥備額為 2.83 億美元，第一季度為 3,900 萬美元，而上一年的數額微不足道。

Our effective tax rate for Q2 was 9%.

我們第二季度的有效稅率為 9%。

Let me remind you of the following.

讓我提醒您以下幾點。

The significant investments to develop the mRNA platform over the last decade resulted in a net operating loss carryforward with a balance of $2.3 billion at the end of 2020.

過去十年來開發 mRNA 平台的大量投資導致淨運營虧損結轉，截至 2020 年底餘額為 23 億美元。

As of December 31, we maintained a full valuation allowance against our deferred tax assets related to these loss carryforwards.

截至 12 月 31 日，我們對與這些損失結轉相關的遞延稅資產保留了全額估值備抵。

As discussed in our last call, we started to release the valuation allowance this year.

正如我們在上次電話會議中所討論的，我們今年開始釋放估值補貼。

The majority of the allowance will flow through the P&L over the course of this year through our effective tax rate, pro rated based on the cadence of our expected pretax quarterly earnings.

大部分津貼將在今年通過我們的有效稅率流入損益表，並根據我們預期稅前季度收益的節奏按比例計算。

Over the course of 2021, the resulting nonrecurring benefit due to the release of the valuation allowance is about 5 percentage points on our effective tax rate.

2021 年期間，由於釋放估價備抵而產生的非經常性收益約為我們的有效稅率的 5 個百分點。

Our Q2 effective tax rate was lower than the U.S. statutory rate, primarily due to the benefit related to the release of the valuation allowance, the foreign-derived intangible income deduction as well as a discrete item for excess tax deductions related to stock-based compensation.

我們第二季度的有效稅率低於美國法定稅率，主要是由於釋放估價津貼、外國無形收入扣除以及與股票薪酬相關的超額稅收扣除的離散項目相關的收益。

We recorded net income of $2.8 billion in Q2 after $1.2 billion in Q1, an increase of 128%.

我們的淨利潤繼第一季度 12 億美元之後，第二季度達到 28 億美元，增長 128%。

Diluted earnings per share for Q2 were $6.46.

第二季度稀釋後每股收益為 6.46 美元。

Turning now to year-to-date financial results compared to prior year on Slide 16.

現在來看幻燈片 16 上與上一年相比的今年迄今為止的財務業績。

Total revenue was $6.3 billion for the 6 months ended June 30 compared to $75 million for the same period in 2020.

截至 6 月 30 日的 6 個月總收入為 63 億美元，而 2020 年同期總收入為 7500 萬美元。

The significant growth was driven by the sales of 302 million doses of the company's COVID-19 vaccine.

這一顯著增長是由該公司的 3.02 億劑 COVID-19 疫苗銷量推動的。

Cost of sales was $943 million or 16% of the company's product sales for the 6 months ended June 30, including third-party royalties of $232 million.

截至 6 月 30 日的 6 個月，銷售成本為 9.43 億美元，占公司產品銷售額的 16%，其中包括 2.32 億美元的第三方特許權使用費。

Reported cost of sales was reduced by 3 percentage points due to the consumption of previously expensed inventory of approximately $200 million.

由於消耗了約 2 億美元的先前費用化庫存，報告的銷售成本降低了 3 個百分點。

Research and development expenses were $822 million for the 6 months ended June 30 compared to $267 million for the same period in 2020.

截至 6 月 30 日的 6 個月，研發費用為 8.22 億美元，而 2020 年同期為 2.67 億美元。

The growth in spending in '21 was largely driven by increased mRNA-1273 clinical development and headcount.

21 年支出的增長主要是由 mRNA-1273 臨床開發和人員數量的增加推動的。

Selling, general and administrative expenses were $198 million for the 6 months ended June 30, compared to $61 million for the same period in 2020.

截至 6 月 30 日的 6 個月，銷售、一般和管理費用為 1.98 億美元，而 2020 年同期為 6100 萬美元。

The growth in spending in 2021 was mainly attributable to the company's COVID-19 vaccine commercialization activities.

2021年支出的增長主要歸因於該公司的COVID-19疫苗商業化活動。

For the 6 months ended June 30, we recorded provision for income taxes of $322 million compared to an insignificant amount for the period in 2020.

截至 6 月 30 日的 6 個月，我們記錄的所得稅撥備為 3.22 億美元，與 2020 年同期相比微不足道。

Our effective tax rate for the 6 months ended June 30 was 7%.

截至 6 月 30 日的 6 個月，我們的有效稅率為 7%。

It was lower than the U.S. statutory rate, primarily due to the nonrecurring benefit related to the release of the valuation allowance, the ongoing benefit of the foreign-derived intangible income deduction as well as a discrete item for excess tax deductions related to stock-based compensation.

它低於美國法定稅率，主要是由於與釋放估價津貼相關的非經常性收益、外國衍生無形收入扣除的持續收益以及與股票相關的超額稅收扣除的離散項目賠償。

Net income was $4 billion for the 6 months ended June 30 compared to a net loss of $241 million for the same period in 2020.

截至 6 月 30 日的 6 個月淨利潤為 40 億美元，而 2020 年同期淨虧損為 2.41 億美元。

Diluted earnings per share were $9.30 for the 6 months ended June 30, 2021.

截至 2021 年 6 月 30 日止 6 個月的稀釋每股收益為 9.30 美元。

Turning to cash and selected cash flow information on Slide 17.

轉向幻燈片 17 上的現金和選定的現金流量信息。

We ended Q2 with cash and investments of $12.2 billion compared to $8.2 billion at the end of Q1.

第二季度末，我們的現金和投資為 122 億美元，而第一季度末為 82 億美元。

The increase is driven by our commercial sales and additional customer deposits received in the second quarter for future purchases of our COVID-19 vaccine.

這一增長是由我們的商業銷售和第二季度收到的額外客戶押金推動的，這些押金用於未來購買我們的 COVID-19 疫苗。

Net cash provided by operating activities was $4.1 billion in Q2 after $3 billion in Q1, totaling then $7 billion year-to-date.

經營活動提供的淨現金在第一季度為 30 億美元後，第二季度為 41 億美元，今年迄今總計 70 億美元。

This compares to net cash used in operating activities of $130 million in the prior year.

相比之下，上一年經營活動使用的淨現金為 1.3 億美元。

Cash used for purchase of property and equipment was $65 million for the 6 months ended June 30 compared to $25 million for the same period in 2020.

截至 6 月 30 日的 6 個月，用於購買財產和設備的現金為 6500 萬美元，而 2020 年同期為 2500 萬美元。

Similar to last quarter, before providing an updated financial framework for the remainder of 2021, let me point out a few areas that are important to keep in mind when modeling expected '21 financial performance, starting with cost of sales on Slide 18.

與上季度類似，在提供 2021 年剩餘時間的更新財務框架之前，讓我指出在對 21 年預期財務業績進行建模時需要牢記的幾個重要領域，從幻燈片 18 上的銷售成本開始。

Cost of sales includes the cost of goods manufactured, third-party royalties as well as logistics and warehousing costs.

銷售成本包括製造商品的成本、第三方特許權使用費以及物流和倉儲成本。

As you may recall, we began capitalizing our COVID-19 vaccine inventory cost in December 2020 following Emergency Use Authorization.

您可能還記得，在獲得緊急使用授權後，我們於 2020 年 12 月開始將 COVID-19 疫苗庫存成本資本化。

Prior to the authorization, inventory costs were recorded as research and development expenses in the period incurred.

授權前，存貨成本計入發生當期的研究開發費用。

In Q1, a zero-cost inventory balance of $184 million was sold and benefited our cost of sales.

第一季度，零成本庫存餘額售出 1.84 億美元，這有利於我們的銷售成本。

If inventory sold during the first quarter was valued at actual cost, our cost of sales would have been $377 million or 22% of product sales.

如果第一季度銷售的庫存按實際成本計價，我們的銷售成本將為 3.77 億美元，佔產品銷售額的 22%。

In Q2, cost of sales of $750 million or 18% of product sales were no longer materially impacted by the zero-cost inventory, hence, the relevant comparison is the adjusted ratio in Q1.

第二季度，7.5 億美元的銷售成本（佔產品銷售額的 18%）不再受到零成本庫存的重大影響，因此，相關比較是第一季度調整後的比率。

The reduction of cost of sales as a percent of product sales when comparing to the adjusted cost of sales in Q1 is primarily driven by a customer mix-driven increase in our average selling price during the second quarter.

與第一季度調整後的銷售成本相比，銷售成本佔產品銷售額的百分比下降，主要是由於第二季度客戶組合驅動的平均銷售價格上漲。

Now turning to our cash and investment position on Slide 19.

現在轉向幻燈片 19 上的現金和投資狀況。

The cash and investment balance reported as of June 30 was $12.2 billion, up from $8.2 billion as of March 31.

截至 6 月 30 日報告的現金和投資餘額為 122 億美元，高於截至 3 月 31 日的 82 億美元。

The increase is driven by our commercial activities, including net increase in customer deposits for future product supply of COVID-19 vaccine.

這一增長是由我們的商業活動推動的，包括用於未來供應 COVID-19 疫苗的客戶存款淨增加。

The net cash balance of customer deposits increased from $5.6 billion at the end of Q1 to $6.8 billion as of June 30.

截至6月30日，客戶存款現金淨額從一季度末的56億美元增至68億美元。

Turning to Slide 20.

轉向幻燈片 20。

I wanted to share our capital allocation priorities.

我想分享我們的資本配置優先事項。

We seek to optimize our capital deployment and maximize long-term shareholder returns.

我們尋求優化資本配置並最大化股東的長期回報。

Our top investment priority will continue to be reinvesting in the base business across multiple areas.

我們的首要投資重點將繼續是對多個領域的基礎業務進行再投資。

For R&D, we have more than tripled spending in the first half of 2021 relative to the prior year, and we will continue to significantly increase spending in this area to advance and accelerate our pipeline.

在研發方面，我們 2021 年上半年的支出比上一年增加了兩倍多，我們將繼續大幅增加該領域的支出，以推進和加速我們的研發進程。

For manufacturing, we previously disclosed our 2021 capital expenditure plans, which will allow us to increase our production capacity.

對於製造業，我們之前披露了 2021 年的資本支出計劃，這將使我們能夠提高產能。

Additionally, we are investing heavily in digital, automation and AI as well as scaling up our global commercial operations, which will allow us to maximize the impact of our mRNA platform.

此外，我們正在數字化、自動化和人工智能方面大力投資，並擴大我們的全球商業運營，這將使我們能夠最大限度地發揮 mRNA 平台的影響。

Our second investment priority is to seek attractive external investment and collaboration opportunities to further expand the reach of Moderna's technology and capabilities.

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 的技術和能力的範圍。

We are considering attractive, strategic opportunities that enable and complement our platform and take a disciplined approach in evaluating potential outside investments.

我們正在考慮有吸引力的戰略機會，以支持和補充我們的平台，並在評估潛在的外部投資時採取嚴格的方法。

After evaluating internal and external investment opportunities, we then assess additional uses of cash.

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。

As part of today's press release, we announced that the Board has authorized a $1 billion share repurchase program.

作為今天新聞稿的一部分，我們宣布董事會已批准一項價值 10 億美元的股票回購計劃。

This program is authorized for a 2-year period.

該計劃的授權期限為 2 年。

Based on the strength of our financial results for the first half of the year and our confidence in our business outlook, we believe it is an appropriate time to initiate this program.

基於我們上半年的強勁財務業績以及我們對業務前景的信心，我們認為現在是啟動該計劃的合適時機。

Turning now to the 2021 updated financial framework on Slide 21.

現在轉向幻燈片 21 上的 2021 年更新財務框架。

Signed Advanced Purchase Agreements for expected delivery in 2021 reflect the current full year total of approximately $20 billion in anticipated product sales, including the $5.9 billion of product sales already generated in the first half of this year.

已簽署的預計 2021 年交付的預購協議反映出當前全年預計產品銷售額總額約為 200 億美元，其中包括今年上半年已產生的 59 億美元產品銷售額。

For the full year, we continue to expect a minimum supply of 800 million doses at the 100 microgram dose level.

我們繼續預計全年 100 微克劑量水平的最低供應量為 8 億劑。

Our manufacturing team and our partners continue working to supply up to 1 billion doses for 2021.

我們的生產團隊和合作夥伴將繼續努力，在 2021 年供應多達 10 億劑疫苗。

We have signed Advanced Purchase Agreements for expected delivery in 2022 for total product sales of approximately $12 billion and options for an additional $8 billion.

我們已簽署預購協議，預計將於 2022 年交付，產品總銷售額約為 120 億美元，並有額外 80 億美元的選擇權。

Numerous additional negotiations are still ongoing for 2022 APAs.

2022 年預約定價安排的大量額外談判仍在進行中。

We have also started to sign APAs for 2023.

我們還開始簽署 2023 年預約定價安排。

As we previously announced, we continue to make investments to increase our supply of vaccine, including by working with contract manufacturing organizations.

正如我們之前宣布的，我們將繼續進行投資以增加疫苗供應，包括與合同製造組織合作。

We currently anticipate that our supply could be as high as 3 billion doses for 2022 if our sales are primarily at a 50 microgram dose level.

目前，如果我們的銷售主要集中在 50 微克劑量水平，我們目前預計 2022 年我們的供應量可能高達 30 億劑。

If sales are primarily at the 100 microgram dose level, we anticipate that supply will be approximately up to 2 billion doses.

如果銷售主要集中在 100 微克劑量水平，我們預計供應量將約為 20 億劑。

The ultimate approach on dosage levels for 2022 and where we might end up in that range is subject to ongoing internal review as well as discussions with regulators and customers and will also be impacted by the mix of primary and booster series.

2022 年劑量水平的最終方法以及我們最終可能達到的劑量範圍取決於持續的內部審查以及與監管機構和客戶的討論，並且還將受到初級和加強系列組合的影響。

Our total cost of sales includes the cost of goods manufactured, third-party royalties as well as logistics and warehousing costs.

我們的總銷售成本包括製造商品的成本、第三方特許權使用費以及物流和倉儲成本。

For 2021, we now expect the average cost total of sales as a percent of product sales to be between 18% to 20% compared to our previous outlook of approximately 20% of product sales.

對於 2021 年，我們目前預計平均銷售成本總額佔產品銷售額的百分比將在 18% 至 20% 之間，而我們之前的預期約為產品銷售額的 20%。

This reflects the successful ramp-up of this global manufacturing network.

這反映了該全球製造網絡的成功發展。

With regard to planned R&D and SG&A expenses, Q2 expenses of approximately $542 million reflect a quarter-over-quarter increase of 13%, in line with the outlook we gave in Q1.

就計劃研發和銷售、一般行政費用而言，第二季度開支約為 5.42 億美元，環比增長 13%，與我們第一季度的預期一致。

We continue to plan for an increase on a quarter-over-quarter basis for the remainder of this year and expect this growth rate to accelerate as the business rapidly expands.

我們繼續計劃在今年剩餘時間內實現環比增長，並預計隨著業務的快速擴張，這一增長率將會加快。

Based on further increased visibility of the utilization of our accumulated net operating loss carryforward, expected global sales mix and the mentioned discrete benefits in the first half of this year, we now expect our all-in 2021 tax rate to be approximately 10%.

基於我們對今年上半年累計淨營業虧損結轉利用率、預期全球銷售組合以及上述離散效益的進一步了解，我們現在預計 2021 年的總體稅率約為 10%。

This compares to our previous forecast in the low-teen range.

與我們之前的預測相比，該預測處於低青少年範圍內。

This forecast is based on current U.S. tax policy and does not include any future potential discrete benefits related to stock-based compensation.

該預測基於美國當前的稅收政策，不包括與股票薪酬相關的任何未來潛在的離散福利。

Finally, regarding capital investments, we maintained our forecast for a range of $450 million to $550 million, including the planned capacity expansion investments as announced on April 29 of this year.

最後，關於資本投資，我們維持 4.5 億至 5.5 億美元的預測不變，包括今年 4 月 29 日宣布的計劃產能擴張投資。

This concludes my remarks, and I turn the call over to Jackie Miller.

我的發言到此結束，我將電話轉給傑基·米勒。

Yes.

是的。

Good morning, good afternoon, everyone.

大家早上好，下午好。

My name is Jacqueline Miller, and I lead the therapeutic area for infectious diseases.

我叫杰奎琳·米勒，負責傳染病治療領域的工作。

And it's my pleasure today to give you an update to the ongoing accumulation of data in our Phase III clinical study and also to talk about some of the publications of real-world evidence that have occurred outside of Moderna with the use of our COVID-19 vaccine.

今天我很高興向您介紹我們 III 期臨床研究中不斷積累的數據的最新情況，並談論在 Moderna 之外使用我們的 COVID-19 發表的一些真實世界證據疫苗。

So on Slide 24, a you'll see the top line updates to our COVE efficacy trial.

因此，在幻燈片 24 上，您將看到我們的 COVE 功效試驗的主要更新。

And these are efficacy data that have now been followed through 4 to 6 months after subjects received their second vaccination of either mRNA-1273 or placebo.

這些是在受試者接受第二次 mRNA-1273 或安慰劑疫苗接種後 4 至 6 個月內追踪的療效數據。

Recall that at the time of our EUA submission, our primary efficacy analysis demonstrated efficacy to COVID-19 of 94.1%.

回想一下，在我們提交 EUA 時，我們的主要療效分析表明對 COVID-19 的療效為 94.1%。

Now 4 to 6 months after second dose, we see a maintenance of that efficacy of 93.2% with a lower limit of the 95% confidence interval of 91%.

現在，在第二次給藥後 4 至 6 個月，我們發現該療效維持在 93.2%，95% 置信區間的下限為 91%。

We continue to maintain efficacy against severe COVID-19 disease with updated vaccine efficacy of 98.2% and currently have 100% of efficacy against death caused by COVID-19.

我們繼續保持對嚴重 COVID-19 疾病的功效，更新後的疫苗功效為 98.2%，目前對 COVID-19 引起的死亡有 100% 的功效。

So unfortunately, there were 3 deaths in the placebo group and up till now, none in the mRNA-1273 group.

不幸的是，安慰劑組有 3 人死亡，而到目前為止，mRNA-1273 組沒有一人死亡。

We continue to see consistency in our subgroup analyses, including analyses by gender, by race and by preexisting medical condition.

我們繼續看到亞組分析的一致性，包括按性別、種族和既往醫療狀況進行的分析。

Our safety profile continues to be consistent with the Phase III data over the longer period of safety follow-up and also continues to be consistent across population subgroups.

在較長時期的安全隨訪中，我們的安全性狀況繼續與 III 期數據一致，並且在不同人群亞組中也繼續保持一致。

Next slide, please, on Slide 25.

請下一張幻燈片，幻燈片 25。

You'll see the efficacy data broken out by time interval.

您將看到按時間間隔細分的功效數據。

And so what you see at the top of the table is the overall efficacy we just discussed.

因此，您在表格頂部看到的是我們剛剛討論的整體功效。

According to the primary end point, we start measuring vaccine efficacy at 14 days after dose 2. And again, that's 93.1%.

根據主要終點，我們在第 2 劑接種後 14 天開始測量疫苗功效。同樣，這是 93.1%。

If you look between 14 days post dose 2 to less than 2 months after dose 2, we observed vaccine efficacy of 91.8% and 94% if you look 2 months after dose 2 to less than 4 months after dose 2. And finally, greater than 4 months after dose 2, we observed 92.4% efficacy.

如果您在第2 劑接種後14 天到第2 劑接種後不到2 個月期間觀察，我們觀察到疫苗功效為91.8%；如果您在第2 劑接種後2 個月到第2 劑接種後不到4 個月觀察，我們觀察到疫苗功效為94%。最後，大於第 2 劑給藥後 4 個月，我們觀察到有效率 92.4%。

And the conclusion we take from these data is that our efficacy has remained consistently high and durable throughout the period of follow-up.

我們從這些數據中得出的結論是，我們的療效在整個隨訪期間始終保持高且持久。

And we intend to continue to follow these data now that the trial is in its open-label phase.

既然試驗處於開放標籤階段，我們打算繼續跟踪這些數據。

The reports will be different moving forward, given that subjects in the placebo group have recently been vaccinated, but we think it's important that we continue to see -- to follow as subjects remain further out from their initial vaccination.

鑑於安慰劑組中的受試者最近已經接種了疫苗，未來的報告將會有所不同，但我們認為重要的是，我們繼續觀察 - 跟踪受試者距離初次接種疫苗的時間還很遠。

So if you go to Slide 26, you'll see that these data have been consistent also in studies outside of the Moderna clinical trial.

因此，如果您查看幻燈片 26，您會發現這些數據在 Moderna 臨床試驗之外的研究中也是一致的。

So we begin to see real-world effectiveness data that demonstrate that Moderna maintains effectiveness consistent with what was seen in the COVE study.

因此，我們開始看到現實世界的有效性數據，表明 Moderna 保持與 COVE 研究中所見一致的有效性。

There are reports from Canada, from the United Kingdom and from Qatar.

有來自加拿大、英國和卡塔爾的報導。

And importantly, these trials confirm that there is vaccine effectiveness, not only against the Wuhan strain, but also against emerging variants of concern, including the Alpha, Beta, Gamma and Delta variants, and this is even after partial vaccination or vaccination with a single dose.

重要的是，這些試驗證實，疫苗不僅對武漢毒株有效，而且對新出現的令人擔憂的變種也有效，包括阿爾法、貝塔、伽瑪和德爾塔變種，甚至在部分疫苗接種或單一疫苗接種後也是如此。劑量。

So if you move to Slide 27, I'm now going to hand over the presentation to Stephen Hoge, who will review our COVID-19 booster strategy and clinical data as well as a review of our pipeline.

因此，如果您轉到幻燈片 27，我現在將把演示文稿交給 Stephen Hoge，他將審查我們的 COVID-19 加強策略和臨床數據以及我們的管道審查。

Stephen?

斯蒂芬？

Thank you, Jackie.

謝謝你，傑基。

So moving on to Slide 28.

現在轉到幻燈片 28。

I want to start with an update of our perspective on COVID-19 and how it's impacting our strategy for boosters.

我想首先介紹一下我們對 COVID-19 的最新看法以及它如何影響我們的加強戰略。

So first, our emerging perspective.

首先，我們的新興觀點。

We believe today that the increased force of infection that's resulting from the Delta variant, fatigue with non-pharmaceutical interventions and the seasonal effects of moving indoors will eventually lead to an increase in breakthrough infections in vaccinated individuals.

今天，我們相信，由 Delta 變種導致的感染力增強、非藥物干預措施帶來的疲勞以及搬入室內的季節性影響最終將導致接種疫苗的個體中突破性感染的增加。

In fact, there have been reports of that already.

事實上，已經有相關報導。

While we see durable Phase III efficacy through 6 months, which Jackie just described, we do expect that neutralizing titers will continue to wane and, eventually, that will impact vaccine efficacy.

雖然我們看到了持續 6 個月的 III 期療效（正如 Jackie 剛才所描述的），但我們確實預計中和滴度將繼續減弱，最終將影響疫苗功效。

So given this intersection between a rising force of infection and waning immunity, we believe a dose 3 of a booster will likely be necessary to keep us as safe as possible through the winter season in the Northern Hemisphere.

因此，考慮到感染力上升和免疫力下降之間的交叉點，我們認為可能需要注射 3 劑加強劑，才能確保我們在北半球的冬季盡可能安全。

So how has that informed our booster strategy?

那麼這對我們的助推器策略有什麼影響呢？

Well, our primary approach since early this year has been to advance a portfolio of booster candidates against all of the potential emerging variants of concern.

嗯，自今年年初以來，我們的主要方法是針對所有潛在的新興變體推出一系列增強候選藥物。

And so we have a large number of ongoing clinical studies, and I'll provide some update on some today.

因此，我們有大量正在進行的臨床研究，今天我將提供一些最新進展。

Those boosters are being evaluated often at 2 different dose levels: 50 micrograms and 100 micrograms.

這些加強劑通常以 2 種不同的劑量水平進行評估：50 微克和 100 微克。

And they fall broadly into 3 categories.

它們大致分為三類。

First is our prototype vaccine, mRNA-1273, for which Jackie just described the primary efficacy data out of our Phase III study.

首先是我們的原型疫苗 mRNA-1273，Jackie 剛剛描述了我們 III 期研究的主要功效數據。

Second, we are looking at variant-specific booster candidates, Beta and now a new Delta variant-specific candidate.

其次，我們正在研究特定於變體的助推器候選者、Beta 以及現在的新的 Delta 變體特定候選者。

And third, we are looking at a multivalent platform, combining different variants into a single vaccine, first, our mRNA-211 (sic) [mRNA-1273.211] program and now a new mRNA-213 (sic) [mRNA-1273.213] program, which includes the Delta antigen.

第三，我們正在尋找一個多價平台，將不同的變體組合成單一疫苗，首先是我們的mRNA-211（原文如此）[mRNA-1273.211] 計劃，現在是新的mRNA-213（原文如此） [mRNA-1273.213] 計劃，其中包括 Delta 抗原。

The goal of the multivalent platform is to continue to try and stay ahead of where the virus is going by combining different antigens against emerging variants of concern.

多價平台的目標是通過結合不同的抗原來對抗新出現的令人關注的變體，繼續嘗試並保持領先於病毒的發展方向。

So I'd like to provide a brief update today on the 3 pre-existing programs: MRNA-1273; our variant-specific booster candidate against the Beta strain, 351; and our first multivalent vaccine, 211.

因此，今天我想對 3 個現有項目進行簡要更新：MRNA-1273；我們針對 Beta 菌株的變體特異性加強候選疫苗，351；以及我們的第一種多價疫苗 211。

Moving to Slide 29.

轉到幻燈片 29。

I have the comparison of those 3 candidates from our phase 201 study.

我對我們 201 期研究中的這 3 名候選人進行了比較。

So quickly, starting on the left-hand side, looking in the validated clinical assays -- these are the same assays that are conducted by our collaborators at NIH that were used for our Phase III study and earlier clinical work.

很快，從左側開始，查看經過驗證的臨床測定——這些測定與我們在 NIH 的合作者進行的測定相同，用於我們的 III 期研究和早期臨床工作。

We can look at the wild-type virus neutralization of the 3 different booster approaches.

我們可以看看 3 種不同的加強方法對野生型病毒的中和作用。

Arrayed left to right, you see our prototype, 1273; our Beta-specific variant of concern, 1273.351; and the multivalent combination of 1273 and Beta, which is MRNA-1273.211.

從左到右排列，您可以看到我們的原型，1273；我們關注的 Beta 特定變體，1273.351； 1273和Beta的多價組合，即mRNA-1273.211。

As a reminder, all 3 of these were dosed at 50 micrograms.

提醒一下，所有 3 種藥物的劑量均為 50 微克。

And what I'm showing you on the left-hand side is the pseudovirus neutralization titers in the validated assays.

我在左側向您展示的是經過驗證的檢測中的假病毒中和滴度。

At day 1, immediately prior to boosting; day 29; and in some cases, day 15.

第 1 天，加強前；第 29 天；在某些情況下，是第 15 天。

Now all of the participants in the study have previously received the Moderna vaccine, 2 doses, just as Jackie had described.

現在，正如 Jackie 所描述的那樣，該研究的所有參與者之前都已接種過 2 劑 Moderna 疫苗。

And at approximately 6 to 8 months after they had participated in one of our clinical studies, we offered them a chance for this booster.

在他們參加我們的一項臨床研究大約 6 到 8 個月後，我們為他們提供了一次加強注射的機會。

So you can see at the baseline day 1, 6 to 8 months after primary series, neutralizing titers are somewhat lower in all 3 cases.

因此，您可以看到，在初級系列後 6 至 8 個月的基線第 1 天，所有 3 個病例的中和滴度均稍低。

With a booster dose of vaccine, all 3 boosters, we were able to substantially increase the neutralization against the wild-type virus, as you can see, for 1273, 16.7-fold; approximately 11-fold at both day 15 and day 29 for the Beta variant of concern; and 38- to 46-fold with the 211 multivalent platform.

使用加強劑量的疫苗（所有 3 個加強劑量），我們能夠大幅提高針對野生型病毒的中和效果，如您所見，達到 1273 倍，即 16.7 倍；對於所關注的 Beta 變體，第 15 天和第 29 天均約為 11 倍； 211 多價平台是 38 至 46 倍。

So that's against the ancestral virus on the left.

所以這是針對左邊的祖先病毒。

How do we do against the variants of concern?

我們如何應對所關注的變體？

Well, at the time when we initiated the study, we were particularly concerned about the B1351 variant, that now it's named Beta variant; and the P1 Gamma variant.

那麼我們開始研究的時候,我們特別關心B1351這個變體,現在叫Beta變體,和 P1 Gamma 變體。

And what we did is we set up assays to evaluate the performance of the booster vaccines 2 weeks after booster in all of those, and again, compared it against the ancestral virus, D614G that we've used elsewhere.

我們所做的是建立測定法來評估加強疫苗 2 週後所有這些疫苗的性能，並再次將其與我們在其他地方使用的祖先病毒 D614G 進行比較。

What you can see in all 3 cases is when you compare the boosting that's happening and compare that to the level of titers, neutralizing titers that was seen in each of those groups of people, against their 2 month -- 1 month post their second dose, you can see strong boosting against all the variants of concern by all 3 booster strategies.

在所有3 種情況下，您可以看到，當您比較正在發生的增強效果並將其與滴度水平進行比較時，每組人群中觀察到的中和滴度與第二次注射後2 個月至1 個月的滴度水平進行比較，您可以看到所有 3 個助推器策略對所有關注的變體都有強大的助推作用。

In fact, it's very encouraging to see that 1273, our prototype vaccine, was able to increase titers against the 351 strain and the P1 Gamma strain.

事實上，令人非常鼓舞的是我們的原型疫苗 1273 能夠提高針對 351 毒株和 P1 Gamma 毒株的效價。

Now as you look to the left, you'll see the level of boosting might be slightly higher with our multivalent platform, which is directionally higher titers, particularly against the 351 and P1 stream.

現在，當您向左看時，您會發現我們的多價平台的增強水平可能會稍高，該平台的滴度定向更高，特別是針對 351 和 P1 流。

But overall, the boosting remains strong across all 3 variants of -- all 3 approaches.

但總體而言，所有 3 種方法的所有 3 種變體的提升仍然強勁。

And as a result of this data, we've made the determination that against these variants of concern, we believe the prototype vaccine, mRNA-1273, is more than sufficient as a booster and that there's no obvious advantage to working with the Beta-including variant boosters at this time.

根據這些數據，我們已經確定，針對這些令人擔憂的變體，我們相信原型疫苗 mRNA-1273 作為加強劑綽綽有餘，並且與 Beta 疫苗合作沒有明顯的優勢此時包括變體助推器。

It's also worth noting that the epidemiology has moved away from the Beta variant of concern towards the Delta variant of concern that we've spoken about extensively.

還值得注意的是，流行病學已經從關注的 Beta 變體轉向我們廣泛討論過的 Delta 變體。

So how did we do then in that 1273 against the Delta variant of concern?

那麼我們在 1273 中對抗 Delta 變種的表現如何呢？

Moving to Slide 30.

轉到幻燈片 30。

I'm presenting data here, which has been submitted for -- in a manuscript.

我在這裡展示的數據是在手稿中提交的。

It's actually in press as we speak.

正如我們所說，它實際上正在新聞中。

Looking at the performance of 1273 over 6 months after primary series against the variants of concern.

看看 1273 在初選系列賽結束後 6 個月內與所關注變體的表現。

The third dose booster of 50 microgram of 1273, pseudovirus neutralization titers here in our research assays is shown.

在我們的研究測定中，顯示了 50 微克 1273 假病毒中和滴度的第三劑量加強劑。

And just to orient you quickly to the slide, we're looking against wild-type, Beta, Gamma and Delta variants of concern.

為了讓您快速了解幻燈片，我們正在研究令人關注的野生型、Beta、Gamma 和 Delta 變體。

The data on the first 3 columns deals with the month 1, post-dose 2. So immediately following the primary vaccination series for which we have the really strong efficacy data that Jackie just described.

前 3 列的數據涉及第 1 個月、第 2 次給藥後。因此，在初級疫苗接種系列之後，我們立即獲得了 Jackie 剛才描述的非常強的功效數據。

And as you can see, we see high titers against the wild-type strain, 1,200 in this assay in this group, and substantially lower titers against the Beta and Gamma variants of concern, as has previously been reported.

正如您所看到的，我們看到針對野生型菌株的滴度較高，在該組的檢測中為1,200，而針對所關注的Beta 和Gamma 變體的滴度則明顯較低，正如之前報導的那樣。

Following those subjects forward to months 6 to 8 after their second dose, what you can see is waning, both for the wild-type virus, although it remains detectable levels of titers, but also for the variants of concern, particularly Beta, Gamma and Delta.

隨著這些受試者在第二次接種後第6 至8 個月，您可以看到，野生型病毒的滴度正在減弱，儘管其滴度仍然可檢測到，而且對於令人關注的變種，特別是Beta、Gamma 和三角洲。

In fact, as you can appreciate in those middle 4 bars, Beta, Gamma and Delta neutralizing titers had fallen below the detectable -- the level of detection of the assay for a decent number of participants in all 4 -- all 3 cases.

事實上，正如您在中間 4 個條中可以看到的那樣，Beta、Gamma 和 Delta 中和滴度已降至可檢測水平以下，即所有 4 個案例中相當數量的參與者的檢測水平。

Now the great news is that a 50 microgram dose of mRNA-1273 was able to boost against all 4 of those viral strains.

現在好消息是，50 微克劑量的 mRNA-1273 能夠增強對抗所有 4 種病毒株的效果。

And 14 days post dose 3, we show the titers on the far right, again, all 4 bars.

第 3 次給藥後 14 天，我們再次在最右側顯示滴度，全部 4 個條形圖。

We saw 23-fold boosting against the wild-type strain to levels that are significantly above the level we've seen just after second dose, 1 month post dose 2; saw 32-fold boosting against Beta; 43-fold boosting against Gamma; and 42-fold boosting against Delta.

我們看到針對野生型菌株的 23 倍增強，其水平顯著高於我們在第二次劑量後（即第 2 次劑量後 1 個月）所看到的水平；與 Beta 相比，提升了 32 倍； 43 倍增強對抗 Gamma；與達美航空相比提升了 42 倍。

Again, all reaching levels that are significantly higher than previously seen.

同樣，所有達到的水平都明顯高於之前看到的水平。

And that is very encouraging, and we think confirms our selection of the prototype booster as likely to be protective against the circulating variants of concern, particularly Delta presently.

這是非常令人鼓舞的，我們認為證實了我們對原型助推器的選擇可能能夠防止流行的令人擔憂的變種，特別是目前的達美航空。

So advancing that mRNA-1273 program at 50 microgram booster into Phase II is something we did in parallel.

因此，我們同時將 50 微克增強劑的 mRNA-1273 項目推進到 II 期。

And on Slide 31, I'm happy to provide an update on the Phase II results from that larger study of the prototype booster.

在幻燈片 31 上，我很高興提供對原型助推器進行更大規模研究的第二階段結果的最新信息。

So earlier this year, our Phase II study of mRNA-1273 was amended to offer a third dose of 1273 at 50 micrograms to all interested participants 6 months out from their second dose of the vaccine.

因此，今年早些時候，我們對 mRNA-1273 的 II 期研究進行了修改，在第二劑疫苗接種 6 個月後，向所有感興趣的參與者提供第三劑 1273，劑量為 50 微克。

A total of 344 participants elected to receive that dose.

共有 344 名參與者選擇接受該劑量。

And the top line results are reported here, and we have a manuscript in preparation that we'll be submitting shortly.

這里報告了最重要的結果，我們正在準備一份手稿，我們將很快提交。

The results are generally consistent with what I've already shared from the Choi, et al data.

結果與我已經分享的 Choi 等人的數據基本一致。

And that means that was that neutralizing antibody titers had waned significantly prior to boosting at 6 months.

這意味著中和抗體滴度在 6 個月加強之前已顯著下降。

No surprise.

沒有驚喜。

A third dose, 50 micrograms, of mRNA-1273 boosted neutralizing titers to levels that are above the Phase III benchmark.

第三劑 50 微克 mRNA-1273 將中和滴度提高至高於 III 期基準的水平。

And again, this now being done in our clinically validated assays with our colleagues at NIH.

再說一遍，我們現在正在與 NIH 的同事一起通過臨床驗證的檢測來完成這項工作。

After a third dose, similar levels of neutralizing titers were achieved across age groups.

第三次給藥後，各年齡組的中和效價水平相似。

And importantly, a subgroup analysis of older adults over the age of 65 showed they were both able to boost significantly and achieve levels that are comparable to younger adults, which is really encouraging.

重要的是，對 65 歲以上老年人的亞組分析表明，他們都能夠顯著提高並達到與年輕人相當的水平，這確實令人鼓舞。

And the safety profile following the dose 3 50 micrograms was similar to that observed previously for dose 2 of mRNA-1273.

3-50 微克劑量後的安全性與之前觀察到的 mRNA-1273 劑量 2 的安全性相似。

In total, we think this is really encouraging data on the potential for a 50 microgram booster of mRNA-1273.

總的來說，我們認為這對於 50 微克 mRNA-1273 增強劑的潛力來說確實是令人鼓舞的數據。

So moving to Slide 32, where does that leave us on our COVID booster strategy or a delayed third dose approximately 6 to 12 months after vaccination?

那麼轉到幻燈片 32，這對我們的新冠疫苗加強策略或疫苗接種後約 6 至 12 個月延遲第三劑疫苗有何影響？

Well, we believe a booster dose is likely to be necessary this fall, particularly in the face of the Delta variant.

好吧，我們相信今年秋天可能需要加強劑量，特別是面對 Delta 變體。

Our clinical data right now, we think, supports a 50 microgram mRNA-1273 booster, and we see no obvious advantage for Beta-containing variant candidates, driven both by the data I presented today and the evolving epidemiology.

我們認為，我們目前的臨床數據支持 50 微克 mRNA-1273 增強劑，並且由於我今天提供的數據和不斷發展的流行病學，我們認為含有 Beta 的變異候選者沒有明顯的優勢。

But we're going to wait for 100 microgram data in the coming weeks to confirm the dose selection of 50 micrograms as the booster before filing.

但我們將在未來幾週內等待 100 微克數據，以確認在提交之前選擇 50 微克作為加強劑的劑量。

So moving off from the COVID booster, I'd like to provide a little bit of an update on the other parts of our pipeline.

因此，在結束新冠肺炎助推器之後，我想提供一些有關我們管道其他部分的最新信息。

So moving to Slide 33.

現在轉到幻燈片 33。

We were excited to update today that mRNA-1010, our first seasonal influenza vaccine candidate has entered the clinic, and that 1010 is moving quickly towards -- in its ongoing Phase I/II study.

我們今天很高興地宣布，我們的第一個季節性流感候選疫苗 mRNA-1010 已進入臨床，並且 1010 正在快速邁向正在進行的 I/II 期研究。

I'll remind you that mRNA-1010 is a quadrivalent seasonal flu vaccine that's targeting the WHO recommended strains.

我要提醒您的是，mRNA-1010 是一種四價季節性流感疫苗，針對的是 WHO 推薦的毒株。

And our vision is to eventually combine mRNA-1010 as a seasonal flu vaccine in a pan-respiratory vaccine booster for adult and elderly populations that combine flu, a COVID-19 booster and potentially our respiratory syncytial virus vaccine.

我們的願景是最終將 mRNA-1010 作為季節性流感疫苗與成人和老年人群的泛呼吸道疫苗加強疫苗結合起來，將流感、COVID-19 加強疫苗和我們的呼吸道合胞病毒疫苗結合起來。

Looking on Slide 34.

查看幻燈片 34。

Across our infectious disease portfolio, beyond 1010, we have a number of other important updates.

在我們的傳染病產品組合中，除了 1010 之外，我們還有許多其他重要更新。

In our RSV vaccine, our positive interim Phase I data was announced at Vaccine Day earlier this year.

在我們的 RSV 疫苗中，我們在今年早些時候的疫苗日宣布了積極的第一階段中期數據。

And Phase I dosing in pediatric and adult vaccine is ongoing.

兒童和成人疫苗的第一階段給藥正在進行中。

We recently were pleased to announce that we received FDA Fast Track Designation for adults over the age of 60 in this -- for this vaccine, highlighting the significant unmet need that we believe is there in this disease.

我們最近很高興地宣布，我們獲得了 FDA 針對 60 歲以上成年人的快速通道指定——這種疫苗，突顯了我們認為這種疾病存在的重大未滿足需求。

Our hMPV/PIV3 vaccine, another multivalent respiratory vaccine, is in a Phase Ib trial that's currently enrolling in toddlers, and the first cohort has been completely enrolled.

我們的 hMPV/PIV3 疫苗是另一種多價呼吸道疫苗，正在進行 Ib 期試驗，目前正在幼兒中進行招募，第一批隊列已全部招募完畢。

Our CMV vaccine against a significant unmet need is on track to start its pivotal Phase III trial this year with roughly 8,000 participants.

我們針對未滿足的重大需求的 CMV 疫苗有望於今年開始關鍵的 III 期試驗，約有 8,000 名參與者。

And lastly, our Zika vaccine Phase II trial is ongoing.

最後，我們的寨卡疫苗二期試驗正在進行中。

We're currently enrolling patients in the United States and Puerto Rico.

我們目前正在美國和波多黎各招募患者。

Moving to Slide 35.

轉到幻燈片 35。

We beyond our expanding infectious disease vaccine portfolio, we are advancing in mRNA therapeutics and now have 7 programs in ongoing clinical trials.

除了不斷擴大的傳染病疫苗產品組合之外，我們還在 mRNA 療法方面取得進展，目前有 7 個項目正在進行臨床試驗。

In oncology, our cancer vaccines programs with Merck include the personalized cancer vaccine in KRAS.

在腫瘤學方面，我們與默克公司的癌症疫苗項目包括 KRAS 中的個性化癌症疫苗。

And we have 2 intratumoral programs in ongoing Phase I studies: one, a triplet program ourselves; and an IL-12 program in combination with AstraZeneca.

我們有 2 個正在進行的 I 期研究中的瘤內項目：一個是我們自己的三聯體項目；另一個是我們自己的三聯體項目。以及與阿斯利康聯合的 IL-12 項目。

In our cardiovascular therapeutic area, we have 2 programs: the VEGF program ongoing with AstraZeneca in Phase II; and a preclinical Relaxin program.

在我們的心血管治療領域，我們有2個項目：與阿斯利康正在進行的二期VEGF項目；和臨床前鬆弛素計劃。

In autoimmune, we are excited to announce that we have started dosing our first patient in an IL-2 Phase I study, and that continues.

在自身免疫方面，我們很高興地宣布，我們已開始在 IL-2 I 期研究中對第一位患者進行給藥，並且該研究仍在繼續。

And the PD-L1 program remains in preclinical development.

PD-L1項目仍處於臨床前開發階段。

And lastly, in rare diseases, we have been dosing for this year in our propionic acidemia program in Phase I; and MMA, GSD1a and PKU programs are in preclinical, and we look forward to starting these in the clinic.

最後，在罕見疾病方面，我們今年在第一階段的丙酸血症項目中一直在給藥； MMA、GSD1a 和 PKU 項目正處於臨床前階段，我們期待著在臨床上啟動這些項目。

Briefly on Page 36.

簡要介紹第 36 頁。

You can see our expanding pipeline of clinical programs and the continued advancement across all of our therapeutic areas, but most notably of our prophylactic vaccines modality in infectious diseases.

您可以看到我們不斷擴大的臨床項目渠道以及我們所有治療領域的持續進步，但最引人注目的是我們在傳染病方面的預防性疫苗模式。

With that, I'd like to turn the call back to Stéphane Bancel for closing remarks.

說到這裡，我想將電話轉回給 Stéphane Bancel，讓其致閉幕詞。

Thank you, Corinne, David, Jackie and Stephen.

謝謝科琳、大衛、傑基和斯蒂芬。

Before taking your questions, let me share a few thoughts.

在回答大家的問題之前，讓我先分享一些想法。

On this slide, we articulate how we have been thinking for many years now about using our mRNA platform to maximize our impact on patients.

在這張幻燈片上，我們闡明了多年來我們如何思考如何使用我們的 mRNA 平台來最大限度地提高對患者的影響。

On the left, we now have 2 core modalities.

在左邊，我們現在有兩種核心模式。

For vaccines in blue, we have achieved authorized products; and for systemic secreted and cell surface therapeutics in pink, we have achieved human proof-of-concept with our chikungunya antibodies, demonstrating we could get therapeutic level of antibodies, and we could repeat those successfully.

藍色疫苗我們已經取得授權產品；對於粉紅色的系統分泌和細胞表面治療，我們已經用我們的基孔肯雅抗體實現了人體概念驗證，證明我們可以獲得治療水平的抗體，並且我們可以成功地重複這些。

In the middle, we have 4 exploratory modalities, which were in the clinic with 6 programs to understand if we achieve human proof-of-concept: 4 medicines in immuno-oncology; 1 in cardiology; 1 in rare genetic disease.

中間，我們有 4 種探索模式，在臨床中有 6 個項目來了解我們是否實現了人類概念驗證：4 種免疫腫瘤學藥物； 1 心髒病學； 1 罕見遺傳病。

More are coming in the coming quarters.

未來幾個季度還將推出更多產品。

On the right, you see 2 modalities which are not yet in the clinic, but for which we believe we have achieved the important derisking in nonhuman primates: delivery of mRNA to the lung and delivery of mRNA into hematopoietic stem progenitor cells.

在右側，您可以看到兩種尚未進入臨床的方式，但我們相信我們已經在非人類靈長類動物中實現了重要的去風險化：將mRNA 遞送至肺部和將mRNA 遞送至造血幹祖細胞。

Next slide, core modalities.

下一張幻燈片，核心模式。

In vaccine, we're focusing on bringing to market what we believe could be a game-changing respiratory vaccine.

在疫苗方面，我們致力於將我們認為可能改變遊戲規則的呼吸道疫苗推向市場。

That medicine would combine, over time, COVID-19 boosters plus seasonal flu boosters plus RSV booster in one single annual shot.

隨著時間的推移，這種藥物將在每年一次的注射中將 COVID-19 加強劑、季節性流感加強劑和 RSV 加強劑結合起來。

We have a great vaccine against COVID-19.

我們有一種很好的針對 COVID-19 的疫苗。

Our RSV clinical data have shown a high level of neutralizing antibodies, which has led the FDA to grant us Fast Track Designation.

我們的 RSV 臨床數據顯示出高水平的中和抗體，這促使 FDA 授予我們快速通道資格。

And our quadrivalent flu vaccine is in the clinic now.

我們的四價流感疫苗現已投入臨床。

The flu market is $5 billion to $6 billion per year despite flu vaccine efficacy being notoriously suboptimal, around 60% in a good year and down to around 30% in a bad year.

流感市場每年價值 50 億至 60 億美元，儘管眾所周知，流感疫苗的功效並不理想，好年份約為 60%，壞年份則降至 30% 左右。

We believe we can do better with our mRNA platform given what we have demonstrated with COVID-19.

鑑於我們在 COVID-19 中所展示的成果，我們相信我們的 mRNA 平台可以做得更好。

The Moderna flu vaccine candidate could launch as early as 2023.

Moderna 候選流感疫苗最早可能於 2023 年推出。

CMV is now close to entering Phase III.

CMV 目前已接近進入 III 期。

And we continue to believe the market opportunity could be $2 billion to $5 billion per year.

我們仍然相信每年的市場機會可能達到 20 億至 50 億美元。

EBV should enter the clinic soon.

EBV應該很快就會進入臨床。

There is no vaccine against CMV infection or EBV infection.

沒有針對 CMV 感染或 EBV 感染的疫苗。

So we are working towards moving the company from COVID-19 prime vaccination sales in 2021 to COVID-19 booster in 2021 and 2022 and beyond, and then adding flu as early as 2023, and then adding RSV and launching CMV and then EBV.

因此，我們正在努力將公司從2021 年的COVID-19 主要疫苗銷售轉向2021 年和2022 年及以後的COVID-19 加強疫苗銷售，然後最早在2023 年添加流感疫苗，然後添加RSV 並推出CMV，然後是EBV。

I am excited about this vaccine pipeline and how these vaccines could prevent death, hospitalization and disease in billions of people over the years.

我對這個疫苗系列以及這些疫苗如何多年來預防數十億人死亡、住院和疾病感到興奮。

Stephen and the research team are not resting.

斯蒂芬和研究團隊並沒有休息。

They are working in our labs on more vaccine candidates, and we cannot wait to share with you these new vaccine candidates in the future as we take them into clinical studies.

他們正在我們的實驗室研究更多候選疫苗，我們迫不及待地與您分享這些新的候選疫苗，因為我們將來會將它們納入臨床研究。

This is where the power of mRNA as an information molecule and the industrialization of Moderna and the digitalization of Moderna and our cash position will enable our teams to bring important vaccine to protect people at a scale and at a pace not seen before in pharmaceutical industry.

這就是 mRNA 作為信息分子的力量、Moderna 的工業化和 Moderna 的數字化以及我們的現金狀況將使我們的團隊能夠以製藥行業前所未見的規模和速度帶來重要的疫苗來保護人們。

In autoimmune disease, we aim to continue to scale that therapeutic area.

在自身免疫性疾病方面，我們的目標是繼續擴大該治療領域。

Next slide, exploratory modalities, 6 clinical programs in 4 exploratory modalities.

下一張幻燈片，探索模式，4 種探索模式的 6 個臨床項目。

If we get positive clinical signal, we'll scale these modalities quickly as well.

如果我們獲得積極的臨床信號，我們也會快速擴展這些模式。

That's where the beauty of a platform comes into play.

這就是平台之美髮揮作用的地方。

Next slide, modalities in research.

下一張幻燈片，研究模式。

Very typical of our long-term mindset and our desire to maximize our impact on patients, we continue to invest in science to explore new modalities, like the one in the lung and more recently presented at our Science Day in hematopoietic stem cells.

我們繼續投資科學來探索新的模式，例如肺部的模式以及最近在我們的科學日上介紹的造血幹細胞模式，這是我們長期思維方式和最大限度地提高對患者影響的願望的典型體現。

In our lung program, we are both working on using mRNA to express a human protein in a cell.

在我們的肺部項目中，我們都致力於使用 mRNA 在細胞中表達人類蛋白質。

That was our first Vertex partnership.

這是我們第一次與福泰 (Vertex) 合作。

But we are excited about our exploration of doing gene editing using mRNA to express a gene editing enzyme.

但我們對使用 mRNA 表達基因編輯酶進行基因編輯的探索感到興奮。

That is our second Vertex partnership.

這是我們第二次與福泰 (Vertex) 合作。

Next slide.

下一張幻燈片。

I believe that the uniqueness of Moderna is that we're expanding our impact on patients in 2 dimensions.

我相信 Moderna 的獨特之處在於我們正在二維地擴大對患者的影響。

We are expanding in 2 dimensions at the same time because we have built an industrialized mRNA.

我們同時在二維擴張，因為我們已經建立了工業化的mRNA。

Because mRNA is an information molecule, once we make a medicine work in a modality, like the COVID-19 vaccine, then we use the same 4 building blocks of life to make another vaccine.

因為 mRNA 是一種信息分子，一旦我們使一種藥物以某種方式發揮作用，例如 COVID-19 疫苗，那麼我們就可以使用相同的 4 個生命組成部分來製造另一種疫苗。

So we scale within a modality really fast along the first dimension of the Y axis.

因此，我們沿著 Y 軸的第一個維度在模態內快速縮放。

And the second dimension is to keep expanding new applications of mRNA into new cell types on the X-axis.

第二個維度是在X軸上不斷將mRNA的新應用擴展到新的細胞類型中。

And we are doing both at the same time with different dedicated teams, all powered by our science, or digital and our manufacturing infrastructure.

我們正在與不同的專門團隊同時進行這兩項工作，所有這些都由我們的科學或數字和製造基礎設施提供支持。

David shared earlier our framework for capital allocation now that we are generating significant amount of cash each quarter.

大衛早些時候分享了我們的資本配置框架，因為我們每個季度都會產生大量現金。

Our #1 priority as a company has always been and will continue to be to invest in the business.

作為一家公司，我們的第一要務始終是並將繼續是對業務進行投資。

We continue to believe that we're in the early days of a new class of medicines, mRNA.

我們仍然相信，我們正處於新型藥物 mRNA 的早期發展階段。

And these small molecules more than 100 years ago, a large molecule 50 years ago are any indication, the next 10 to 20 to 40 years are going to see a very large number of important medicines.

這些100多年前的小分子、50多年前的大分子都表明，未來10到20到40年將會出現非常大量的重要藥物。

And because mRNA is an information molecule, it would happen really fast.

因為 mRNA 是一種信息分子，所以它會發生得非常快。

We aim to continue to build the world's leading mRNA company.

我們的目標是繼續打造全球領先的mRNA公司。

So we're talking about investments in acceleration of programs already in the clinic; investments in new development candidates moving from the labs to the clinic; investments in our platform to continue to improve the science and to include new modalities; investment in manufacturing; investment in commercial presence, including our digital and commercial presence; investment in digital so we can scale our company faster and better than traditional biotech or pharma companies.

所以我們談論的是加速臨床項目的投資；對從實驗室到臨床的新開發候選藥物的投資；對我們平台的投資，以繼續改進科學並納入新模式；製造業投資；對商業存在的投資，包括我們的數字和商業存在；對數字化的投資，使我們能夠比傳統的生物技術或製藥公司更快更好地擴大公司規模。

Our second priority is to expand our horizons by complementing our platform with external technologies or products.

我們的第二個優先事項是通過外部技術或產品補充我們的平台來擴大我們的視野。

This means we are interested in nucleic acid technologies, gene therapy, gene editing, mRNA.

這意味著我們對核酸技術、基因治療、基因編輯、mRNA 感興趣。

On the mRNA front, if we find new delivery technologies that could expand our current capabilities, we will look at them carefully.

在 mRNA 方面，如果我們發現新的遞送技術可以擴展我們當前的能力，我們將仔細研究它們。

We would be interested in technology licenses and/or in development candidate licenses and/or, if it makes sense, M&A.

我們會對技術許可和/或開發候選許可和/或併購（如果有意義的話）感興趣。

You can count us to be disciplined.

你可以認為我們是有紀律的。

We know what it takes to go from early research to filing with regulatory agencies.

我們知道從早期研究到向監管機構備案需要什麼。

And for having done it, we know the risk associated with new technologies, and everything that works in a mouse would not necessarily work in a human.

在完成這項工作後，我們知道新技術存在風險，並且在小鼠身上有效的所有方法不一定在人類身上也有效。

From a strategic standpoint, we are not interested in small molecule or large molecule development candidates, even if they could complement our commercial portfolio.

從戰略角度來看，我們對小分子或大分子開發候選藥物不感興趣，即使它們可以補充我們的商業產品組合。

We love information molecules too much to be interested in acquiring analog molecules, small molecule, large recombinant molecules or cell therapy.

我們太喜歡信息分子，以至於對獲取模擬分子、小分子、大重組分子或細胞療法不感興趣。

This share buyback is our first one.

這次股票回購是我們的第一次。

We are very optimistic about the future of Moderna, and we are just getting started.

我們對 Moderna 的未來非常樂觀，而我們才剛剛開始。

Our Board of Directors will continue to regularly review what is the right thing to do to return capital to shareholders in light of our cash generation, balanced against investments in our business and external investment opportunities.

我們的董事會將繼續定期審查如何根據我們的現金生成情況，與我們的業務投資和外部投資機會相平衡，向股東返還資本。

Let me talk now a minute about corporate responsibilities.

現在讓我談談企業責任。

It is very important for us to make Moderna a model of corporate responsibility and to build a sustainable business.

讓 Moderna 成為企業責任的典範並建立可持續發展的業務對我們來說非常重要。

Like everything we do, we don't just want to do things well.

就像我們所做的一切一樣，我們不只是想把事情做好。

We want to do things in the best possible way.

我們希望以盡可能最好的方式做事。

We were pleased to announce recently the establishment of our charitable foundation with an upfront endowment of $50 million with a significant focus on underserved populations.

我們很高興地宣布最近成立了慈善基金會，預捐款 5000 萬美元，重點關注服務不足的人群。

We are humbled to have been awarded the #1 spot on Fast Company 2021 for best place to work for innovators, which complements our last 6 consecutive years of recognition by Science as a top employer.

我們很榮幸在《Fast Company 2021》創新者最佳工作場所評選中榮獲第一名，這也是對我們過去連續 6 年被 Science 評為頂級雇主的補充。

Both awards reflect the importance we place on our employees and the culture of the company.

這兩個獎項都體現了我們對員工和公司文化的重視。

Recently, Axios/Harris released its 2021 corporate reputation survey, and the Moderna brand ranked third among 100 of the most visible U.S. companies, our first mention on the list and a highest ranking for any biopharmaceutical company for corporate reputation.

近日，Axios/Harris 發布了 2021 年企業聲譽調查，Moderna 品牌在 100 家最受關注的美國公司中排名第三，這是我們首次上榜，也是所有生物製藥公司企業聲譽排名最高的。

We have recently worked relentlessly with the U.S. government to facilitate donations of the Moderna COVID-19 vaccine to many low-income countries.

我們最近與美國政府不懈合作，促進向許多低收入國家捐贈 Moderna COVID-19 疫苗。

And we are committed to minimizing our energy footprint.

我們致力於最大限度地減少能源足跡。

As I look through the next decade, the same North Star is guiding us since we started.

當我展望下一個十年時，自我們開始以來，同一顆北極星一直在指引著我們。

We believe we have a responsibility to maximize our impact to protect healthy people and help patients.

我們相信，我們有責任最大限度地發揮我們的影響力，保護健康人群並幫助患者。

Our commitment is stronger than ever.

我們的承諾比以往任何時候都更加堅定。

This is just the beginning.

這僅僅是個開始。

We look forward to welcoming you at our annual R&D Day on September 9, whereas in previous years, we will do a detailed review of our development pipeline.

我們期待在 9 月 9 日舉行的年度研發日歡迎您的到來，而往年，我們將對我們的開發渠道進行詳細審查。

The team and I will happy now to take your questions.

我和我的團隊現在很樂意回答您的問題。

Operator?

操作員？

(Operator Instructions) Your first question comes from the line of Salveen Richter from Goldman Sachs.

（操作員說明）您的第一個問題來自高盛的 Salveen Richter。

Could you walk us through the dynamics for 2022 and beyond in terms of APAs for Spikevax, essentially demand in the context of supply of the 2 billion to 3 billion doses for 2022?

您能否向我們介紹一下 2022 年及以後 Spikevax 的 APA 動態，本質上是 2022 年 20 億至 30 億劑供應背景下的需求？

And then how we should think about the years beyond 2022 and pricing?

那麼我們應該如何考慮 2022 年之後的年份和定價？

And then secondly, with regard to external BD, how are you thinking about integrating areas like gene editing and gene therapy with your platform?

其次，關於外部 BD，您如何考慮將基因編輯和基因治療等領域與您的平台整合？

Maybe I'll start on the answer on '22, '23.

也許我會從 22、23 年開始回答。

So as we said, right now, we're -- we've announced that we're increasing our capacity.

正如我們所說，現在我們已經宣布我們正在增加產能。

We see very strong demand continuing in the context of the pandemic well into 2022.

我們認為，在疫情大流行的背景下，需求將持續非常強勁，直至 2022 年。

And hence, we've given you the range of 2 billion to 3 billion doses depending very much on whether our customers are still purchasing for primary series or if they're looking at boosters and then depending on the eventual dosage for boosters.

因此，我們為您提供了20 億至30 億劑的範圍，這在很大程度上取決於我們的客戶是否仍在購買初級系列產品，或者他們是否正在考慮加強劑，然後取決於加強劑的最終劑量。

So I think it's really going to evolve as to exactly what that looks like in terms of dosage.

所以我認為劑量方面確實會發生變化。

Going beyond '22, as we said, we are starting to see now the forward-planning countries that are looking beyond the very near term.

正如我們所說，22 世紀之後，我們現在開始看到一些前瞻性規劃國家的目光超越了近期。

We're starting to then have contract discussions and in fact, have agreed some contracts into '23.

然後我們開始進行合同討論，事實上，我們已經就 23 年的一些合同達成了一致。

But I think it's early to really know as to how this is going to evolve in terms of the transition from pandemic to the endemic phase.

但我認為現在真正了解從大流行階段到地方病階段的過渡將如何演變還為時過早。

In terms of pricing, I think it's helpful to start with where we are in 2021 to have a context for understanding pricing going forward.

在定價方面，我認為從 2021 年的情況入手，了解未來定價的背景是有幫助的。

So really 3 buckets of pricing in 2021.

所以 2021 年的定價確實有 3 個階段。

We have the U.S. government, where the first 100 million doses was priced at a little over $15.

我們有美國政府，前 1 億劑的價格略高於 15 美元。

The subsequent 400 million doses were contracted at $16.50.

隨後的 4 億劑疫苗合同價格為 16.50 美元。

And that pricing was considering a couple of things.

該定價考慮了幾件事。

One is the BARDA funding we received to underwrite our Phase III trial, and also the size of the contract, the 500 million dose contract, which is very large.

一是我們收到的 BARDA 資金用於承保我們的 III 期試驗，還有合同的規模，即 5 億劑合同，這是非常大的。

The second category is the higher-income ex U.S. countries where, as we've said in the past, we start with a price range of $32 to $37 a dose.

第二類是美國以外的高收入國家，正如我們過去所說，我們的起始價格範圍為每劑 32 至 37 美元。

And there are some cases where we offer discounts based on volume, for high volume.

在某些情況下，我們會根據數量提供折扣，對於大批量的情況。

And then the third category is low and middle-income countries, which have received the lowest-tiered pricing, including those sales to COVAX, which are considerably lower than the price to the U.S. government.

第三類是低收入和中等收入國家，這些國家的定價最低，包括向 COVAX 的銷售，其價格大大低於向美國政府的價格。

So if we start with that framework for '21, what we can say is that the contracts that we've signed now for 2022, the pricing constructs are very consistent with that framework that we've had in 2021.

因此，如果我們從 21 年的框架開始，我們可以說我們現在簽署的 2022 年合同、定價結構與我們 2021 年的框架非常一致。

And so we see a continuation in the context again of the pandemic with the pricing framework.

因此，我們看到在大流行的背景下定價框架再次延續。

If you look at the average price that you calculate in your model, of course, that's going to depend on the mix across these categories.

當然，如果您查看模型中計算的平均價格，這將取決於這些類別的組合。

And of course, we're expecting to see significant sales to the middle and low-income countries and that increasing in '22.

當然，我們預計中低收入國家的銷售額將大幅增加，並且在 22 年還會有所增加。

So it shouldn't be surprising if the average, you see some declines.

因此，如果平均數出現一些下降，也就不足為奇了。

And then finally, I would just comment that as we move into a post-pandemic period, then we would expect, as we've said in the past, to -- market forces to impact our price negotiations.

最後，我只想評論說，當我們進入大流行後時期時，正如我們過去所說，我們預計市場力量會影響我們的價格談判。

So hopefully, that answers your questions.

希望這能回答您的問題。

And Salveen, I'll maybe just pipe in at the end with your first question on gene editing, which is -- how do we see it intersecting?

Salveen，我可能會在最後插話你關於基因編輯的第一個問題，即——我們如何看待它的交叉？

Look, I think we have been, as you all know, the innovator in mRNA and lipid nanoparticle delivery in therapeutics for a while.

聽著，我認為，正如你們所知，一段時間以來我們一直是治療學中 mRNA 和脂質納米顆粒遞送的創新者。

And we've watched the space quite interestingly or quite significantly in terms of ways that we could help with delivering gene editing cargoes across a range of different tissues where our lipid nanoparticles systems have been shown to go even in humans.

我們非常有趣或非常重要地觀察了這個領域，我們可以幫助在一系列不同的組織中傳遞基因編輯貨物，在這些組織中，我們的脂質納米顆粒系統已被證明甚至可以在人類身上發揮作用。

And we think it's the right time for us to start to expand in that direction.

我們認為現在是我們開始朝這個方向擴張的最佳時機。

If there's a general convergence, I think, out there in the gene editing space, it's that messenger RNA and lipid nanoparticles are perhaps the way to go.

我認為，如果基因編輯領域存在普遍的趨同，那麼信使 RNA 和脂質納米顆粒可能是可行的選擇。

And that's something we strongly agree with having spent the last decade working in the technology.

這是我們在過去十年致力於該技術的過程中強烈同意的一點。

So you'll be looking for us to bring new kind of payloads, new capabilities, new enzymes into our existing technological capabilities, which we think are best-in-class.

因此，您會希望我們將新型有效負載、新功能、新酶帶入我們現有的技術能力中，我們認為這些技術能力是一流的。

And your next question comes from the line of Matthew Harrison from Morgan Stanley.

你的下一個問題來自摩根士丹利的馬修哈里森。

Great.

偉大的。

A couple of related questions on boosters, if I may.

如果可以的話，有幾個關於助推器的相關問題。

I guess first question is, maybe you could just put in context some of the information we're hearing from the FDA or the CDC, especially ACIP on their position on boosters.

我想第一個問題是，也許你可以把我們從 FDA 或 CDC 聽到的一些信息放在上下文中，特別是 ACIP 關於他們對加強劑的立場。

And how you would expect that to evolve over the coming months?

您預計未來幾個月情況會如何發展？

Second, could you comment on the potential for a multivalent booster?

其次，您能否評論一下多價增強劑的潛力？

And how you might be thinking about that in the context of the data you presented today, especially just on using a third dose of the existing shot?

結合您今天提供的數據，尤其是使用現有疫苗的第三劑，您可能會如何考慮這一點？

And then third, could you maybe just comment on your views of long-term virus evolution?

第三，您能否評論一下您對病毒長期進化的看法？

Obviously, typically, viruses tend to evolve towards more infectious, but lower virulence.

顯然，病毒通常傾向於進化為更具傳染性但毒力較低。

And so I'm wondering what your thoughts are on the long-term booster market, obviously, versus the sort of near-term booster market when infections may still be quite high?

因此，我想知道您對長期加強市場的看法，顯然，與感染率可能仍然很高的短期加強市場有何不同？

Sure.

當然。

Thank you, Matthew.

謝謝你，馬修。

So let me try and take the first question first.

讓我先嘗試回答第一個問題。

So I think we are going to always defer to what's happening with the public health officials in terms of when they think the appropriate time to recommend a booster vaccine is necessary.

因此，我認為我們將始終尊重公共衛生官員的情況，以了解他們何時認為有必要推薦加強疫苗。

Where we see the data ourselves -- I can't speak to the challenges they face.

當我們自己看到數據時——我無法談論他們面臨的挑戰。

But what we see is the potential for waning immunity.

但我們看到的是免疫力有可能減弱。

In fact, if you look at -- back at our Vaccines Day, we had Professor Davenport come in and present work that he's done at University of New South Wales in Australia showing what he predicted back in March would be the picture for waning immunity from the vaccines.

事實上，如果你回顧一下我們的疫苗日，我們請達文波特教授介紹了他在澳大利亞新南威爾士大學所做的工作，展示了他在三月份預測的免疫力減弱的情況。疫苗。

It was recently published in Nature Medicine.

它最近發表在《自然醫學》雜誌上。

I had a chance to open and it's looking remarkably prescient because the predictions he was making about the relative strength of the different vaccines suggested that small differences in efficacy would start to emerge to be larger differences in efficacy at about 200, 250 days as neutralizing antibody titers waned.

我有機會打開它，它看起來非常有先見之明，因為他對不同疫苗的相對強度所做的預測表明，效力的微小差異將開始在大約200、250 天作為中和抗體時開始出現更大的效力差異滴度下降。

And that may be what we're starting to see.

這可能就是我們開始看到的。

And if you play that forward, if you assume he's been right about those predictions, then that picture continues and continues through a year with continued declining neutralizing antibody titers over that time.

如果你扮演前鋒，如果你認為他的這些預測是正確的，那麼這種情況就會持續下去，並持續一年，在此期間中和抗體滴度持續下降。

And eventually, we therefore believe, a real increase in breakthrough infections and disease even with vaccinated participants, even with mRNA-1273.

因此，我們相信，最終，即使是接種疫苗的參與者，即使是使用 mRNA-1273，突破性感染和疾病也會真正增加。

So we continue to want to be vigilant because that trend and those predictions, we think, will come to the fore.

因此，我們繼續保持警惕，因為我們認為這種趨勢和這些預測將會脫穎而出。

And I think the Delta variant has taught us to also be incredibly humble in the face of the virus' ability to fight back and increase its transmission.

我認為德爾塔變種教會我們在面對病毒的反擊和增加其傳播的能力時要保持極其謙虛的態度。

I mean I think most of us would have thought SARS-CoV-2 was a pretty good infector earlier this year.

我的意思是，我想今年早些時候我們大多數人都會認為 SARS-CoV-2 是一種很好的感染者。

Delta has shown us that it can make huge steps forward.

達美航空向我們展示了它可以向前邁出巨大的一步。

And so for all those reasons, we think that it's appropriate to be cautious.

因此，出於所有這些原因，我們認為保持謹慎是適當的。

Our approach is not to -- is to defer to public health on when boosters are going to be necessary, but to bring forward the best option as we see them based on the science that we see and the evolving epidemiology.

我們的方法不是——而是在何時需要加強疫苗的問題上遵循公共衛生的要求，而是根據我們所看到的科學和不斷發展的流行病學，提出我們認為最好的選擇。

And that's where, I think, our conclusion today is given Beta, Gamma and particularly Delta, given the real-world efficacy that we're seeing out there against Delta right after vaccination with 1273 and the neutralizing titers that we can see, that I presented today, against Delta with the 1273 prototype dose, that we feel pretty confident that, that's actually the right way to approach this round of the fight with the SARS-CoV-2 virus.

我認為，這就是我們今天的結論是 Beta、Gamma，特別是 Delta，因為我們在接種 1273 疫苗後立即看到了針對 Delta 的實際功效，以及我們可以看到的中和滴度，我認為今天推出的針對Delta 的1273 原型劑量，我們非常有信心，這實際上是與SARS-CoV-2 病毒進行這一輪鬥爭的正確方法。

Now if I jump to the second and third questions you asked, this is not the last round of the fight with SARS-CoV-2.

現在，如果我跳到你問的第二和第三個問題，這不是與 SARS-CoV-2 的最後一輪戰鬥。

We expect it to have at least a couple more rounds and maybe annually, we're just going to continue to fight this virus back.

我們預計它至少還會有幾輪，也許每年一次，我們將繼續對抗這種病毒。

And that's where we think multivalent boosters continue to be an important part of the scientific strategy.

這就是我們認為多價增強劑仍然是科學策略的重要組成部分的地方。

As you look forward to, say, early 2022, Delta is what we're fighting right now.

正如你所期待的，比如說 2022 年初，達美航空就是我們現在正在對抗的對象。

But what are we going to be fighting in 2022?

但2022年我們要打什麼仗呢？

What new variant of concern?

值得關注的新變體是什麼？

There will be one.

會有一個。

And I look at the evolving picture with Delta and the overall variants of concern, and there's a couple of specific things that jump out at me.

我觀察了達美航空不斷發展的情況以及所關注的總體情況，有一些具體的事情引起了我的注意。

There are now I think 5 point mutations in the various variants of concerns, 3 of them present in Beta and Gamma.

現在我認為不同的關注點有 5 個點突變，其中 3 個存在於 Beta 和 Gamma 中。

We've talked about them, the 417, 484 and 501 mutations.

我們已經討論過 417、484 和 501 突變。

And now there's 2 mutations in the receptor binding domain in the Delta strain at 452 and 478.

現在 Delta 菌株的受體結合域有 2 個突變，分別為 452 和 478。

And those 5 look like the ways in which the virus has tried to step away from our neutralizing immunity with our vaccine immune innovation.

這五種看起來像是病毒試圖通過疫苗免疫創新來擺脫我們的中和免疫力的方式。

If you think about how this might play forward, it seems logical to us that those 3 mutations present in the Beta, Gamma line and those 2 mutations present in the Delta might find some way to combine in new and potentially scary ways.

如果你考慮一下這將如何發展，對我們來說，Beta、Gamma 系中存在的3 個突變和Delta 中存在的2 個突變可能會找到某種方式以新的、潛在的可怕方式結合起來，這似乎是合乎邏輯的。

And if that came with the increased transmissibility, force of infection that Delta can achieve, that might be a significant threat.

如果達美航空能夠提高傳播力和感染力，那可能會構成重大威脅。

And so we view our multivalent platform as the best place for us to try and anticipate that threat.

因此，我們認為我們的多價平台是我們嘗試和預測這種威脅的最佳場所。

And logically, for us right now, that would be looking at a Beta, Gamma or a Beta variant of concern combined with a Delta variant of concern and evaluating that going forward.

從邏輯上講，現在對我們來說，將著眼於關注的 Beta、Gamma 或 Beta 變體與 Delta 變體相結合，並評估未來的情況。

And that's the 213 program that we're going to be looking at.

這就是我們要關注的 213 計劃。

But we don't think that's for this cycle.

但我們認為這不適用於本週期。

We do really believe that 1273, a booster dose, will hold up against Delta right now.

我們確實相信 1273（加強劑量）現在能夠對抗達美航空。

The long-term virus evolution question is a great one.

病毒的長期進化問題是一個重大問題。

And I would say we just got to be humble.

我想說我們必須保持謙虛。

We've not faced a variant, a virus quite like this.

我們還沒有遇到過像這樣的變種、病毒。

And again, I don't think any of us would have predicted the step change in transmissibility that was seen with Delta over the last 5, 6 months.

再說一次，我認為我們中的任何人都不會預測到達美航空在過去 5、6 個月中所看到的傳播能力的階躍變化。

And so I wouldn't rule out that the virus doesn't have that kind of surprises in its future.

因此，我不排除該病毒未來不會出現這種意外。

But if you take a very, very long view, 5, 10 years' view, I would say that we continue to think the model for what SARS-CoV-2 will look like in terms of an endemic market is probably predicted by other respiratory infections, the endemic coronaviruses, like OC43, which every year have rates of reinfection in adult populations and young kids, every year results in hospitalizations and some deaths, including in this country.

但如果你從非常非常長遠的角度來看，5 年、10 年的觀點，我想說的是，我們仍然認為 SARS-CoV-2 在地方性市場方面的模型可能是由其他呼吸道疾病預測的。地方性冠狀病毒，如OC43，每年都會在成年人和幼兒中出現再次感染率，每年都會導致住院和一些死亡，包括在這個國家。

And we, therefore, believe there will be a long-term endemic market.

因此，我們相信將會有一個長期的流行市場。

The virulence of those viruses, as you pointed to, is lower, and that's good news.

正如你所指出的，這些病毒的毒力較低，這是個好消息。

Hopefully, it's not as big of a threat as we're seeing right now.

希望它不會像我們現在看到的那麼大。

But we need to be cautious and humble because SARS-CoV-2 keeps surprising us.

但我們需要謹慎和謙虛，因為 SARS-CoV-2 不斷給我們帶來驚喜。

And maybe that virulence will be something more substantial than we see in the endemic coronavirus.

也許這種毒力會比我們在地方性冠狀病毒中看到的更嚴重。

So we're hopeful that it will wane, that virulence will decline, but we really do believe the virus is here to stay for the long term.

因此，我們希望它會減弱，毒力會下降，但我們確實相信該病毒會長期存在。

And therefore, there's going to be a need to regularly boost, particularly high-risk older populations, against SARS-CoV-2 into the future.

因此，未來需要定期加強對 SARS-CoV-2 的抵抗，特別是對高危老年人群。

Hopefully, those answer your questions.

希望這些能回答您的問題。

And your next question comes from the line of Ted Tenthoff from Piper Sandler.

你的下一個問題來自 Piper Sandler 的 Ted Tenthoff。

Great.

偉大的。

I guess my first question has to do with capacity and really trying to understand a little bit more fully what goes into continuing to grow capacity, especially overseas.

我想我的第一個問題與產能有關，並真正嘗試更全面地了解持續增長產能的原因，尤其是在海外。

And I guess the second question would be with respect to the orphan disease pipeline, which is -- I think you guys know, it's one of my favorites just in terms of application for mRNA.

我想第二個問題是關於孤兒疾病管道，我想你們知道，就 mRNA 的應用而言，這是我最喜歡的管道之一。

How can we be moving faster there?

我們怎樣才能在那裡更快地前進？

Again, appreciating that you guys have a pandemic you're trying to address.

再次感謝你們正在努力應對一場流行病。

But it seems to me like everything is set to go there.

但在我看來，一切都已準備就緒。

And just curious what we can be doing to maybe accelerate some of those important programs.

只是好奇我們可以做些什麼來加速其中一些重要的項目。

Thank you, maybe I'll go...

謝謝你，也許我會去...

I'll take -- go ahead.

我會——繼續。

So I'll take the capacity and then Stephen will talk about rare disease.

所以我將接受會議，然後斯蒂芬將談論罕見疾病。

So as you recall, Ted, we've announced -- I think it was in February that based on the market feedback of the countries, given the high efficacy of our vaccine, so there was a lot of demand.

特德，你還記得嗎，我們已經宣布了——我想是在二月份，根據各國的市場反饋，考慮到我們的疫苗功效很高，所以有很多需求。

And so if you recall, we decided to make very significant manufacturing capacity increase, 50% addition in the U.S. It's all at our U.S. site, the drug substance in Norwood and then the doubling of the OUS capacity at Lonza and ROVI.

因此，如果您還記得的話，我們決定大幅增加生產能力，在美國增加 50%。這一切都在我們的美國工廠，諾伍德的原料藥，然後將 Lonza 和 ROVI 的 OUS 產能增加一倍。

Our goal is to, as I said in my remarks, depending on the booster dose which until we have final say by the regulator and until we see the 100 microgram data for 1273 third dose, as Stephen described, we won't know for sure.

正如我在發言中所說，我們的目標是，取決於加強劑量，直到監管機構做出最終決定，直到我們看到 1273 第三劑的 100 微克數據（正如斯蒂芬所描述的），我們才能確定。

But if you model both the prime series APAs that have already been ordered, which will be, of course, at 100 microgram, if you model what we anticipate in the mix between prime series and booster vaccines for Spikevax, if the booster dose was 50 micrograms, we could have up to 3 billion dose of supply.

但是，如果您對已訂購的 Prime 系列 APA 進行建模（當然，劑量為 100 微克），如果您對 Spikevax Prime 系列和加強疫苗之間的混合模型進行建模，如果加強劑量為 50微克，我們可以供應多達30 億劑量。

And if the booster dose were 100 microgram, that could take us up to 2 billion of supply.

如果加強劑量為 100 微克，我們可能需要 20 億的供應量。

So it's a bit hard to think about it.

所以想起來有點困難。

What we're trying to do is to not have the challenge we're having this year, which is a happy problem.

我們要做的就是不要再遇到今年面臨的挑戰，這是一個令人高興的問題。

As I said in my remarks, we are still tracking for 800 million to 1 billion dose this year.

正如我在發言中所說，今年我們仍在追踪 8 億至 10 億劑量。

But I've also said that we are not taking any more orders for 2021 because we are totally maxed out.

但我也說過，2021 年我們不會再接受任何訂單，因為我們已經完全用完了。

And of course, we would want to be in a position where we can answer to any countries wanting more vaccines.

當然，我們希望能夠滿足任何需要更多疫苗的國家的需求。

And so by doing those investments, we really are hoping that next year, we can make sure that we can fulfill all the demand we're going to get from the market.

因此，通過進行這些投資，我們確實希望明年能夠確保能夠滿足市場上的所有需求。

And as Corinne mentioned, while we have already signed $12 billion of APAs for next year and -- with those countries and additional $8 billion on top of the $12 billion of options that those countries have, there are still a lot of discussions ongoing.

正如Corinne 提到的，雖然我們已經與這些國家簽署了明年120 億美元的APA，並且在這些國家擁有的120 億美元選項之外還簽署了額外的80 億美元，但仍有大量討論正在進行中。

And so what we want to do is to maximize the penetration of Spikevax around the world.

因此，我們想要做的就是最大限度地提高 Spikevax 在全球的滲透率。

And I believe that the new data this morning showing that the efficacy -- the final efficacy of the COVE study is holding very nicely.

我相信今天早上的新數據表明 COVE 研究的最終效果非常好。

I think will just be yet another argument for countries to want to vaccinate as many people as they can in that country with 1273.

我認為這只是各國希望為該國盡可能多的人接種 1273 例疫苗的另一個理由。

Stephen, do you want to talk about orphan disease?

斯蒂芬，你想談談孤兒病嗎？

Sure.

當然。

Yes.

是的。

I mean -- so I said, I think you know we've had a long-standing commitment to these populations, and that's as strong today as ever.

我的意思是——所以我說，我想你知道我們對這些人群有著長期的承諾，而且這種承諾在今天和以往一樣堅定。

And we hear and want to do everything we can to accelerate these medicines for them.

我們聽說並希望盡我們所能來加速為他們提供這些藥物。

It's important to say that it's fast to the finish is the goal, not the fast at the start.

重要的是要說，快到結束才是目標，而不是一開始就快。

And while we're pleased with the start of the propionic acidemia program and, hopefully shortly, MMA and others in the clinic, our goal is obviously to rapidly move through those Phase I studies, to find the right dose and hopefully then rapidly move into pivotal studies.

雖然我們對丙酸血症計劃的啟動感到高興，希望很快就能對MMA 和臨床中的其他項目感到滿意，但我們的目標顯然是快速完成這些I 期研究，找到正確的劑量，並希望隨後迅速進入關鍵研究。

And as you know, that can happen very quickly and so -- particularly in rare diseases, particularly with some early positive clinical data.

如您所知，這種情況可能發生得非常快，尤其是在罕見疾病中，特別是在一些早期積極的臨床數據的情況下。

And so that's what we're trying to do right now, is anticipate that positive data, expand and build out our team in that therapeutic area and begin the more foundational preparations for closing very quickly if we can get some encouraging positive clinical signs.

因此，這就是我們現在正在努力做的，就是預測積極的數據，擴大和建立我們在該治療領域的團隊，並開始更基礎的準備工作，以便在我們能夠獲得一些令人鼓舞的積極臨床症狀時很快結束。

But we're working every day to try and get the -- to accelerate the time that those are incurring early data and -- as well as, as I said, prepare for that future.

但我們每天都在努力嘗試加快獲得早期數據的時間，並且正如我所說，為未來做好準備。

And your next question comes from the line of Michael Yee from Jefferies.

您的下一個問題來自 Jefferies 的 Michael Yee。

Two questions.

兩個問題。

One on boosting.

一是關於提升。

Do you guys have a good sense of what you think the regulatory view or hurdle is to support boosting?

你們是否清楚自己認為支持提振的監管觀點或障礙是什麼？

You show that great data on Slide 30, showing the waning of the antibodies.

您在幻燈片 30 上展示了出色的數據，顯示了抗體的減弱。

And I think we all see that could be a problem, and how the third dose gets you way up.

我想我們都看到這可能是一個問題，以及第三劑如何讓你進步。

But what do you think that specific data is, or put another way, the titer level for correlative protection would be to support boosting for the fall or the winter?

但您認為具體數據是什麼，或者換句話說，相關保護的滴度水平將支持秋季或冬季的加強？

That's question one.

這是問題一。

And then question 2, a little bit similar.

然後是問題2，有點類似。

On flu, with that data coming up later this year, is it your view that significantly higher levels of antibodies will lead to significantly higher efficacy?

關於流感，隨著今年晚些時候的數據公佈，您是否認為抗體水平顯著提高會帶來顯著更高的療效？

And that would suggest a larger study that will also be supportive of a launch, I think you said in 2023.

我想你說過，這意味著需要進行更大規模的研究，這也將支持 2023 年的發布。

Sure.

當然。

So I'll try and take the first question, which was -- so and you point to well, we do not currently have a correlative protection in the world, unfortunately, for any of the vaccines.

因此，我將嘗試回答第一個問題，即您指出的，不幸的是，我們目前在世界上沒有針對任何疫苗的相關保護。

And so it's very hard to say objectively what titer, what level is the sort of the minimum level, which is why in our minds -- and subject to the regulators to developing their own perspective.

因此，很難客觀地說什麼滴度、什麼水平是最低水平，這就是我們認為的原因——並且需要監管機構制定自己的觀點。

But in our mind, the right way to benchmark this has been, let's look at that really consistent, high, durable efficacy in Phase III, let's look at the neutralizing titers that support that.

但在我們看來，衡量這一點的正確方法是，讓我們看看第三階段中真正一致、高、持久的功效，讓我們看看支持這一點的中和滴度。

And let's do better.

讓我們做得更好。

Let's get above those titers.

讓我們超越這些滴度。

Because if we can exceed those titers in where we were just after the primary vaccination series, then it should stand to reason that we should be able to provide durable protection at or above the levels that we saw before.

因為如果我們能夠超過初級疫苗接種系列之後的滴度，那麼我們應該能夠提供等於或高於我們之前看到的水平的持久保護。

Now of course, the virus is evolving, and that's where you see Delta, and we have to be humble about that.

當然，現在病毒正在進化，這就是達美航空的所在，我們必須對此保持謙虛。

But the good news is -- it looks like in the real-world data that the vaccine, 1273, is holding up against Delta even with partial vaccination, as Jackie mentioned in her slides and with some of those references.

但好消息是 - 正如傑基在她的幻燈片和其中一些參考文獻中提到的那樣，從現實世界的數據來看，即使進行了部分疫苗接種，疫苗 1273 也能抵抗 Delta。

And so we do think that getting at or above those levels should hold up quite comfortably.

因此，我們確實認為達到或超過這些水平應該相當容易。

How much above those levels?

比這些水平高出多少？

Is it 1.0?

是1.0嗎？

Is it 2.0?

是2.0嗎？

Is it some other number?

是其他數字嗎？

I think that's ultimately going to be a sense that we want to have between ourselves of the data that we have; the benefits of the different dose levels, 50 microgram, 100 microgram; and again, the data we've already seen in terms of Phase III; and then a dialogue with regulators about how they see that benefit risk.

我認為這最終將是我們希望我們之間對我們所擁有的數據有一種感覺；不同劑量水平（50微克、100微克）的好處；再說一遍，我們已經看到了第三階段的數據；然後與監管機構對話，了解他們如何看待收益風險。

But as it stands today, we think the 50 microgram data that we presented really looks encouraging and likely meet that standard.

但就目前情況而言，我們認為我們提供的 50 微克數據看起來確實令人鼓舞，並且很可能符合該標準。

But we want to hold off.

但我們想推遲。

We'll look at the 100 microgram data in just a few weeks here and decide, nope, that's the right call.

我們將在幾週內查看 100 微克的數據，並決定，不，這是正確的決定。

We've got to the levels we need to.

我們已經達到了我們需要的水平。

And we think we can reset immunity in a vaccinated person with a third dose at or above the levels that have been driving this durable protection to date.

我們認為，通過第三劑疫苗，我們可以重置接種疫苗的人的免疫力，使其免疫力達到或高於迄今為止推動這種持久保護的水平。

I'm sorry, I missed the second question.

抱歉，我錯過了第二個問題。

Could you just repeat it?

你能重複一遍嗎？

Yes.

是的。

Similar, I guess, in flu that when you have data later this year, I suspect you believe the titer levels will be extremely high.

類似地，我想，在流感中，當你今年晚些時候獲得數據時，我懷疑你相信滴度水平會非常高。

I think there's some better understanding, based on regulatory guidance documents, that for flu, there's some acceptable levels.

我認為，根據監管指導文件，人們可以更好地理解流感有一些可接受的水平。

And you could certainly compare it to approved products, that high levels there would be supportive of a larger study and a faster path to market.

您當然可以將其與已批准的產品進行比較，那裡的高水平將支持更大規模的研究和更快的上市途徑。

That's right.

這是正確的。

Yes, thank you for reminding me.

是的，謝謝你提醒我。

So we -- obviously, we haven't provided guidance on when we expect the -- to be able to get through those subsequent studies and, ultimately, what that regulatory path is.

因此，我們 - 顯然，我們還沒有提供有關我們預計何時能夠完成這些後續研究以及最終監管路徑是什麼的指導。

Because we have to engage in that discussion with the FDA and global regulators, and those are ongoing.

因為我們必須與 FDA 和全球監管機構進行討論，而且這些討論正在進行中。

And so it's really subject to them agreeing.

所以這確實需要他們同意。

But I would agree with your characterization.

但我同意你的描述。

It's certainly our hope and view that because it's a well-understood market, with things like the HAI titers, that even a new platform like messenger RNA might be able to leverage some of that thinking in terms of immunogenicity and safety as we think about moving forward to approval.

我們當然希望和認為，因為這是一個眾所周知的市場，具有HAI 滴度之類的東西，所以即使是像信使RNA 這樣的新平台也可能能夠在我們考慮移動時利用免疫原性和安全性方面的一些想法。等待批准。

We'll ultimately have to show efficacy and real-world efficacy as well, because that's what's going to be of interest for payers.

我們最終還必須展示功效和現實世界的功效，因為這才是付款人感興趣的。

But again, the regulatory path is going to be subject to discussions with regulators that are ongoing.

但同樣，監管路徑將取決於與監管機構正在進行的討論。

So I can't provide more guidance at this time.

所以目前我無法提供更多指導。

And your next question comes from the line of Gena Wang from Barclays.

你的下一個問題來自巴克萊銀行的 Gena Wang。

I have 3 quick questions.

我有 3 個簡單的問題。

The first one is if boost should turn out to be 50 microgram, should we still expect similar price range among the 3 buckets during pandemic phase?

第一個是，如果增幅應該是 50 微克，我們是否還應該期望在大流行期間這 3 個類別之間有類似的價格範圍？

And then number two is, could you walk through the clinical trial development path for a single-shot vaccine against COVID, flu and RSV?

第二個問題是，您能否介紹一下針對新冠肺炎、流感和呼吸道合胞病毒的單劑疫苗的臨床試驗開發路徑？

And the third question is regarding the external investment opportunities.

第三個問題是關於外部投資機會。

You mentioned that expanding to 2 new modalities, lung and hematopoietic stem cells with gene editing with lipid nanoparticle delivery currently focusing in the liver.

您提到通過脂質納米顆粒遞送進行基因編輯擴展到兩種新模式，即肺和造血幹細胞，目前主要集中在肝臟。

Does that mean you are willing to expand to the liver diseases?

這是否意味著您願意擴展到肝臟疾病領域？

So let me take the first question, Gena, on the boost.

Gena，讓我來回答第一個問題，關於提升。

The price is not linked to the mass.

價格與質量無關。

So we anticipate the price of boosting to be set up and not related to dose.

因此，我們預計加強價格將被設定，並且與劑量無關。

I'll let Stephen talk about the second question, is that okay?

我讓斯蒂芬談談第二個問題，可以嗎？

So I'm happy to take that question, Stéphane.

所以我很高興回答這個問題，Stéphane。

This is Jackie.

這是傑基。

And it's around the clinical development plan for a booster combination vaccine.

它圍繞加強組合疫苗的臨床開發計劃。

And the good news is there have been multiple combination vaccine developments in the past, maybe not for this kind of a groundbreaking indication.

好消息是，過去已經開發出多種組合疫苗，但可能不是針對這種突破性的適應症。

But typically, what we do is license the initial components first.

但通常情況下，我們所做的是首先許可初始組件。

And you know that we are working on our BLA for COVID.

您知道，我們正在製定新冠病毒 BLA。

We're preparing Phase II/III for flu and for RSV.

我們正在準備針對流感和呼吸道合胞病毒的第二/第三階段。

And then we would look to license the combination vaccine through immunobridging.

然後我們將尋求通過免疫橋接來獲得組合疫苗的許可。

Thank you, Jackie.

謝謝你，傑基。

And I would...

我會...

And then in gene editing...

然後在基因編輯方面......

Go ahead, Stephen.

繼續吧，斯蒂芬。

I was going to take gene editing, unless you want to, Stéphane.

我本來打算進行基因編輯，除非你願意，Stéphane。

One comment, too, on Jackie's point.

對傑基的觀點也有一個評論。

We already do have combination vaccines, like the hMPV/PIV3 vaccines.

我們已經有了聯合疫苗，例如 hMPV/PIV3 疫苗。

So we're -- we, hopefully, we do have some experience there technically.

所以我們——希望我們在技術上確實有一些經驗。

On the gene editing question, we do have, as you know, programs that target the liver.

關於基因編輯問題，如您所知，我們確實有針對肝臟的程序。

But as we've presented at previous Science Days and even today, we have a platform technology that also, we think, allows us to get in broadly into the immune system and particularly hematopoietic stem cells.

但正如我們在之前的科學日乃至今天所展示的那樣，我們認為，我們擁有一種平台技術，它還可以讓我們廣泛進入免疫系統，特別是造血幹細胞。

And so what you'll -- where we imagine our strong suit to be is in delivering nucleic acid technologies to those areas.

因此，我們認為我們的強項是向這些領域提供核酸技術。

And of course, as we look to expanding in gene editing, you'll see us look to those technologies that we've got the most experience with first and then bringing a range of different payloads to -- into our capabilities.

當然，當我們尋求擴展基因編輯領域時，您會看到我們首先關注那些我們擁有最多經驗的技術，然後將一系列不同的有效負載納入我們的能力中。

Next question please, operator?

接線員，請問下一個問題？

Operator?

操作員？

Lavina, it seems that we have lost the operator.

拉維娜，我們好像失去了接線員。

I hope...

我希望...

Yes.

是的。

Cory from JPMorgan, if you are online, can you please unmute yourself and ask your question?

摩根大通的 Cory，如果您在線，可以請您取消靜音並提問嗎？

Okay.

好的。

Apologies, everyone.

抱歉，大家。

We seem to have lost the operator, and it is 25 minutes past the hour.

我們似乎失去了接線員，現在已經是整點 25 分鐘了。

So I will hand it over back to Stéphane Bancel to make closing remarks.

因此，我將把它交還給 Stéphane Bancel 做總結髮言。

Thanks, Lavina.

謝謝，拉維娜。

Sorry, everybody, if you're still hearing us, for the technical problem.

抱歉，大家，如果您仍然聽到我們的技術問題。

We will work with the provider to figure what happened.

我們將與提供商合作弄清楚發生了什麼。

If you have any follow-up questions, please don't hesitate to contact Lavina, who will make sure to reply to you quickly.

如果您有任何後續問題，請隨時聯繫 Lavina，她一定會盡快回复您。

Thank you for coming in today, and we look forward to talking to you at the latest for our R&D Day on September 9. Thank you, and have a great day.

感謝您今天光臨，我們期待最遲在 9 月 9 日的研發日與您交談。謝謝您，祝您有美好的一天。

Bye.

再見。