莫德納 (MRNA) 2020 Q4 法說會逐字稿

Good morning, and welcome to Moderna's Fourth Quarter 2020 Conference Call. (Operator Instructions) Please be advised the call is being recorded.

早上好，歡迎參加 Moderna 2020 年第四季度電話會議。 （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. Please proceed.

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

Thank you, operator. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2020 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website. On today's call are Stéphane Bancel, our CEO; David Meline, our CFO; Stephen Hoge, our President; and Tal Zaks, our Chief Medical Officer.

謝謝你，接線員。大家早上好，感謝您加入我們今天的電話會議，討論 Moderna 的第四季度和 2020 年全年財務業績和業務更新。您可以訪問我們網站的“投資者”部分，訪問今天上午發布的新聞稿以及我們將審查的幻燈片。今天的電話會議是我們的首席執行官 Stéphane Bancel；我們的首席財務官 David Meline；我們的總裁斯蒂芬·霍格；和我們的首席醫療官 Tal Zaks。

Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see Slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments.

在我們開始之前，請注意，本次電話會議將包括根據 1995 年《私人證券訴訟改革法案》的安全港條款做出的前瞻性陳述。請參閱隨附演示文稿的幻燈片 2 和我們提交給 SEC 的重要風險因素可能導致我們的實際業績和結果與這些前瞻性陳述中明示或暗示的內容存在重大差異。我們不承擔因新信息或未來結果或發展而更新或修改本次電話會議中提供的信息的義務。

On Slide 3, please see the important indication and safety information for our COVID-19 vaccine, which has been authorized for emergency use in the United States and many other 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安全信息，該疫苗已獲准在美國和世界上許多其他國家緊急使用。

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

有了這個，我現在將把電話轉給 Stéphane。

Thank you, Lavina. Good morning, or good afternoon, everyone. I hope all of you and your loved ones are in good health. Thank you for taking the time to join our Q4 2020 call.

謝謝你，拉維娜。大家早上好，或者下午好。我希望你們所有人和你們所愛的人都身體健康。感謝您抽出寶貴時間參加我們的 2020 年第四季度電話會議。

For the call, we propose to start first by looking back to fiscal year 2020 and then looking to fiscal year 2021. For fiscal year 2020, I will share a few slides to summarize the key elements of the year, before David shares with you the 2020 financials and also how we think about 2021 financial framework. For fiscal year 2021, I will share our business objectives and why we are so excited for 2021 and the inflection point this year will represent in our history. Stephen will start with an update on our approach to variance of concern and then Tal will provide an update on our clinical pipeline.

對於電話會議，我們建議首先回顧 2020 財年，然後再展望 2021 財年。對於 2020 財年，我將分享幾張幻燈片來總結這一年的關鍵要素，然後大衛與您分享2020 年的財務狀況以及我們如何看待 2021 年的財務框架。對於 2021 財年，我將分享我們的業務目標，以及為什麼我們對 2021 年如此興奮，今年的拐點將代表我們的歷史。 Stephen 將首先更新我們處理關注差異的方法，然後 Tal 將提供我們臨床管道的更新。

2020 was a historic year for Moderna. We started in January as an early-stage development company. By the end of July, we had become a late-stage development company. And by December, we had positive results from our Phase III COVE study of our COVID-19 vaccine showing efficacy around 94%. Our COVID-19 vaccine was authorized by the FDA and Canada Health in mid-December and we shipped [80 million] doses to the U.S. government and the Canadian governments by year-end. We laid the groundwork for a global organization, adding commercial subsidiaries in 8 countries, 8 countries. By year-end, we have signed $11.7 billion of advanced purchase agreement for our vaccine.

2020 年對 Moderna 來說是歷史性的一年。我們從一月份開始作為一家早期開發公司。到7月底，我們已經成為一家後期開發公司。到 12 月，我們對 COVID-19 疫苗的 III 期 COVE 研究取得了積極結果，顯示效力約為 94%。我們的 COVID-19 疫苗於 12 月中旬獲得 FDA 和加拿大衛生部的授權，我們在年底前向美國政府和加拿大政府運送了 [8000 萬劑] 劑。我們為全球組織奠定了基礎，在 8 個國家、8 個國家增加了商業子公司。到年底，我們已經簽署了 117 億美元的疫苗預購協議。

A team of a little over 1,000 members did all that. And we also continue to invest in science to improve further our mRNA platform. And we also advance on 20 programs in development across 5 therapeutic areas. And we did it without a large global pharmaceutical partner.

一個由 1,000 多名成員組成的團隊完成了所有這些工作。我們還繼續投資於科學，以進一步改進我們的 mRNA 平台。我們還在 5 個治療領域推進了 20 個正在開發的項目。我們在沒有大型全球製藥合作夥伴的情況下做到了。

The Moderna team executed swiftly and superbly in carrying out the complicated Phase III study while achieving remarkable diversity. The Moderna team secured the authorization of the COVID-19 vaccine by regulators. The Moderna team built out our manufacturing capacity, scaling up across many manufacturing processes, partnered with Lonza, ROVI and Catalent, and shipped close to 80 million doses by year-end. For context, we had made less than 100,000 doses of medicine in 2019. This was roughly a 200x increase in 12 months. And we're on our way to produce as many as 1 billion doses in 2021 and more in 2022.

Moderna 團隊在執行複雜的 III 期研究時執行迅速而出色，同時實現了顯著的多樣性。 Moderna 團隊獲得了監管機構對 COVID-19 疫苗的授權。 Moderna 團隊擴大了我們的製造能力，擴大了許多製造工藝，與 Lonza、ROVI 和 Catalent 合作，到年底出貨量接近 8000 萬劑。就上下文而言，我們在 2019 年生產了不到 100,000 劑藥物。這在 12 個月內大約增加了 200 倍。我們正在努力在 2021 年生產多達 10 億劑，並在 2022 年生產更多。

In 2019, we had no authorized products. We had negative cash flows from operations every quarter. And we anticipated needing multiple capital raises over at least 5 years until CMV would produce sufficient revenues for Moderna to break even in terms of cash flows and become a self-sustaining company.

2019年，我們沒有授權產品。我們每個季度都有來自運營的負現金流。我們預計至少需要在 5 年內進行多次融資，直到 CMV 為 Moderna 帶來足夠的收入，從而在現金流方面實現收支平衡並成為一家自我維持的公司。

In 2020, we had our first product authorized and our first product revenues in the last 2 weeks of Q4. We had 2 quarters of positive cash flows from operations. We ended the year with a strong balance sheet and with cash generation in 2 quarters.

2020 年，我們在第四季度的最後兩週獲得了第一款產品的授權和第一筆產品收入。我們有兩個季度的運營現金流為正。我們以強勁的資產負債表和兩個季度的現金產生結束了這一年。

Moderna has been changed forever. Moderna has been changed in a profound way. Moderna is now a commercial company with subsidiaries in 8 countries and a direct presence in many more through commercial distributors and partners.

Moderna 已經永遠改變了。 Moderna 發生了深刻的變化。 Moderna 現在是一家商業公司，在 8 個國家/地區設有子公司，並通過商業分銷商和合作夥伴在更多國家/地區直接開展業務。

mRNA is an information molecule. We have a powerful platform, and this is just the beginning. We have a scalable platform due to our investment in IT, robotics and AI over the last 7 years. We have an amazing team, as you witnessed by what the team accomplished in the 12 short months of 2020. And we have a capital to invest and scale.

mRNA是一種信息分子。我們有一個強大的平台，而這僅僅是個開始。由於過去 7 年來我們在 IT、機器人和人工智能方面的投資，我們擁有了一個可擴展的平台。我們擁有一支了不起的團隊，正如您在 2020 年短短 12 個月內所取得的成就所見證的那樣。我們有資本進行投資和擴大規模。

On Slide 6, you have a summary of the countries in which we received emergency use authorization or conditional approvals and all were -- started rolling submission that we did.

在幻燈片 6 上，您可以看到我們收到緊急使用授權或有條件批准的國家/地區的摘要，並且所有這些國家都已開始滾動提交，我們所做的。

On Slide 7, you get a sense for the commercial infrastructure that we built. For context, in May of 2020, Moderna did not have a single employee dedicated to commercial activities. We closed the year with 8 commercial subsidiaries, an incredible commercial team and commercial partners. We now have commercial operations in the U.S.; in Canada; in Europe, in the 5 largest markets, Germany; France; Italy; Spain; and the U.K. We established one in Switzerland, where we have both commercial capabilities to serve the Swiss market as well as manufacturing for geographies outside the U.S. with our partner Lonza and the support teams that we need in finance, HR, digital and legal. We have partnered with Medison in Israel and with Takeda in Japan.

在幻燈片 7 中，您可以了解我們構建的商業基礎設施。就背景而言，在 2020 年 5 月，Moderna 沒有一名員工專門從事商業活動。我們以 8 家商業子公司、令人難以置信的商業團隊和商業合作夥伴結束了這一年。我們現在在美國有商業運營；在加拿大;在歐洲，在 5 個最大的市場，德國；法國;意大利;西班牙;我們在瑞士建立了一家，我們既有商業能力為瑞士市場提供服務，也有與我們的合作夥伴 Lonza 以及我們在財務、人力資源、數字和法律方面所需的支持團隊一起在美國以外的地區進行製造的能力。我們與以色列的 Medison 和日本的武田合作。

If you step back and think about it, this commercial network which we started building and will expand in 2021 is an incredible asset for the entire Moderna pipeline. We now have the infrastructure to commercialize all our products. These markets on the slide are some of the largest markets in the world. So by building the commercial network for the launch of our COVID-19 vaccine and deciding not to partner, we have actually financed and built the commercial network for all of our programs.

如果您退後一步想一想，我們開始建設並將於 2021 年擴展的這個商業網絡對於整個 Moderna 管道來說是一筆不可思議的資產。我們現在擁有將我們所有產品商業化的基礎設施。幻燈片上的這些市場是世界上一些最大的市場。因此，通過為推出我們的 COVID-19 疫苗建立商業網絡並決定不合作，我們實際上已經為我們所有的項目提供了資金並建立了商業網絡。

We have become a fully integrated company, and in 12 months, proved that we're capable of running complex Phase III studies, scaling up manufacturing to commercial level, making hundreds of millions of doses per year and building our own commercial network. As I said, the Moderna team did an amazing job in 2020.

我們已成為一家完全整合的公司，並在 12 個月內證明我們有能力進行複雜的 III 期研究，將生產規模擴大到商業水平，每年生產數億劑，並建立自己的商業網絡。正如我所說，Moderna 團隊在 2020 年做得非常出色。

On Slide 8, you get a glimpse of what Moderna looks like in February 2021. While most people in the world think of Moderna as a COVID-19 vaccine company, this is just the first product that we are launching. We have a platform, and our molecule mRNA is an information molecule. This is just the beginning.

在幻燈片 8 上，您可以看到 Moderna 在 2021 年 2 月的樣子。雖然世界上大多數人都認為 Moderna 是一家 COVID-19 疫苗公司，但這只是我們推出的第一個產品。我們有一個平台，我們的分子mRNA是一個信息分子。這僅僅是開始。

We are going to soon start a Phase III study for vaccine against CMV, cytomegalovirus, the #1 cause of birth defect. There is no approved CMV vaccine on the market. The pharma industry has strived for around 20 years to make a vaccine against CMV. This is a complex virus, a vaccine of 6 mRNAs per dose, over which are 2 from a complex protein called pentamer. We believe that CMV vaccine will present potential annual peak sales between $2 billion and $5 billion.

我們將很快開始一項針對 CMV（鉅細胞病毒）疫苗的 III 期研究，該疫苗是導致出生缺陷的第一大原因。市場上沒有批准的 CMV 疫苗。製藥行業已經努力了大約 20 年來製造針對 CMV 的疫苗。這是一種複雜的病毒，每劑含有 6 個 mRNA 的疫苗，其中 2 個來自稱為五聚體的複雜蛋白質。我們相信 CMV 疫苗的潛在年銷售額峰值將在 20 億美元至 50 億美元之間。

We have 3 programs in Phase II of personal cancer vaccine in melanoma or OX40 ligand in ovarian cancer and injected in patients' hearts, post heart attack, to revascularize their heart with new blood vessels. We have had 12 positive Phase I results.

我們在黑色素瘤的個人癌症疫苗或卵巢癌的 OX40 配體的 II 期項目中有 3 個項目，並在心髒病發作後注射到患者的心臟中，用新血管重建他們的心臟。我們有 12 個積極的第一階段結果。

In addition to our COVID-19 vaccine, we have 8 infectious vaccine candidates, all for first-in-class vaccine like against CMV or what we believe could be a best-in-class vaccine like with influenza. But we also have a remarkable therapeutic pipeline. We have candidate therapeutics in immuno-oncology with 5 medicines in the clinic, 4 in rare disease program, 2 cardio program and 2 autoimmune disease programs.

除了我們的 COVID-19 疫苗外，我們還有 8 種傳染性候選疫苗，全部用於抗 CMV 等一流疫苗或我們認為可能是流感等一流疫苗的疫苗。但我們也有一個非凡的治療管道。我們在免疫腫瘤學方面擁有候選療法，其中有 5 種臨床藥物、4 種罕見疾病計劃、2 種心臟計劃和 2 種自身免疫性疾病計劃。

If you think about it, Moderna is going after the 4 leading cause of death by disease area: infectious disease; cancer; cardiovascular disease; autoimmune disease. The total addressable market is very large. We are not a COVID-19 vaccine company.

如果你仔細想想，Moderna 正在追踪疾病領域的 4 大死因：傳染病；癌症;心血管疾病;自身免疫性疾病。總的潛在市場非常大。我們不是 COVID-19 疫苗公司。

We're investing in science and leveraging our scalable platform to take more candidates from our research lab to clinical development soon. So stay tuned for that. We announced yesterday that we are increasing our base manufacturing plant for the number of COVID-19 doses we will produce in fiscal year 2021 from 600 million to 700 million doses, given the strong start of our U.S. operation and initial ramp of our outside-the-U.S. operation. Our team is still working hard to get us up to 1 billion doses for fiscal year '21.

我們正在對科學進行投資，並利用我們的可擴展平台盡快將更多候選人從我們的研究實驗室帶到臨床開發。所以請繼續關注。我們昨天宣布，鑑於我們在美國業務的強勁開端和我們在美國以外地區的初步增長，我們將在 2021 財年生產的 COVID-19 劑量從 6 億劑增加到 7 億劑。 -我們。手術。我們的團隊仍在努力使我們在 21 財年達到 10 億劑。

Now let me turn to David for Q4 and fiscal year 2021 financial framework. David?

現在讓我談談第四季度和 2021 財年財務框架的大衛。大衛？

Okay. Thank you, Stéphane. Before reviewing the financial section of the slide deck, I want to comment on the approach we've taken sharing this information. This starts with the 3 Cs, these being clear, complete and comprehensible. Today, we are presenting our results primarily on a U.S. GAAP basis. And in individual item level, in some cases, we also provide additional detail to provide greater clarity on underlying trends and to facilitate period-over-period comparisons in line with our 3C goal.

好的。謝謝你，斯蒂芬。在查看幻燈片的財務部分之前，我想評論一下我們共享此信息所採取的方法。這從 3C 開始，它們清晰、完整且易於理解。今天，我們主要根據美國公認會計原則展示我們的結果。在個別項目層面，在某些情況下，我們還提供額外的細節，以更清楚地了解潛在趨勢，並根據我們的 3C 目標促進不同時期的比較。

Reflecting the continued uncertainties related to the course of the evolving pandemic, along with the many challenges and opportunities we face as a newly globalizing commercial company, we also seek to avoid implying an unrealistic level of precision concerning future financial projections in the face of a range of outcomes. With this background, we are providing today the analysis of actual 2020 results, along with a view of key drivers of the financial framework going forward. We will continue to update and refine this information as business evolves.

考慮到與不斷演變的大流行病進程相關的持續不確定性，以及我們作為一家新近全球化的商業公司所面臨的許多挑戰和機遇，我們還力求避免在面對一系列問題時暗示未來財務預測的不切實際水平結果。在此背景下，我們今天提供對 2020 年實際結果的分析，以及對未來財務框架關鍵驅動因素的看法。隨著業務的發展，我們將繼續更新和完善這些信息。

Turning to Slide 10. I want to briefly remind you about some key accounting changes which we presented on this slide in our Q3 call in October. As a result of the successful transition to a commercial company, following the emergency use authorization by the FDA and Health Canada in December 2020, we began to record product sales. We also began to capitalize inventory based on the expectation these costs would be recoverable through commercialization of our COVID-19 vaccine as opposed to expensing costs directly to R&D in the period incurred. And we also began to capitalize purchases of property and equipment and long-term lease assets as opposed to expensing costs in the period incurred through the lack of alternative use.

轉到幻燈片 10。我想簡要提醒您，我們在 10 月份的第三季度電話會議中在這張幻燈片上介紹了一些關鍵的會計變更。由於成功轉型為商業公司，繼 2020 年 12 月獲得 FDA 和加拿大衛生部的緊急使用授權後，我們開始記錄產品銷售。我們還開始將庫存資本化，因為我們預計這些成本可以通過我們的 COVID-19 疫苗的商業化來收回，而不是在發生期間將成本直接用於研發。我們還開始將購買的財產和設備以及長期租賃資產資本化，而不是在因缺乏替代用途而產生的期間費用化。

With this context, let me turn now to Slide #11. Total revenue was $571 million for Q4 2020 compared to $14 million for the same period in 2019. Total revenue was $803 million for the full year 2020 compared to $60 million in the prior year. Following the authorization for emergency use by the FDA and Health Canada in December of our COVID-19 vaccine, we generated our first ever product sales.

在此背景下，讓我現在轉到幻燈片 #11。 2020 年第四季度的總收入為 5.71 億美元，而 2019 年同期為 1400 萬美元。2020 年全年的總收入為 8.03 億美元，而上一年為 6000 萬美元。在 FDA 和加拿大衛生部於 12 月授權緊急使用我們的 COVID-19 疫苗之後，我們實現了有史以來的第一次產品銷售。

For 2020, we recognized $200 million of product sales for our COVID-19 vaccine, all in late December. Additionally, grant and collaboration revenue increased to $371 million in Q4 and $603 million for the full year, primarily due to increases in grant revenue from BARDA to accelerate development of our COVID-19 vaccine.

2020 年，我們在 12 月下旬確認了 2 億美元的 COVID-19 疫苗產品銷售額。此外，第四季度的贈款和合作收入增至 3.71 億美元，全年增至 6.03 億美元，這主要是由於 BARDA 為加速開發 COVID-19 疫苗而提供的贈款收入增加。

Now turning to cost of sales. We began capitalizing our COVID-19 vaccine inventory costs in December, starting after the vaccine was first authorized based upon our expectation that these costs would be recoverable through commercialization of the vaccine. Prior to the authorization of our COVID-19 vaccine, inventory costs were recorded as research and development expenses in the period incurred.

現在轉向銷售成本。我們於 12 月開始資本化 COVID-19 疫苗庫存成本，從疫苗首次獲得授權開始，基於我們的預期，這些成本將通過疫苗的商業化來收回。在我們的 COVID-19 疫苗獲得授權之前，庫存成本在發生期間記錄為研發費用。

We expensed $242 million of prelaunch inventory costs in 2020. Hence, our cost of sales were only $8 million in 2020, comprised primarily of third-party royalties. If inventory sold during 2020 was valued at cost, our cost of sales for 2020 would have been $62 million or 31% of our product sales.

我們在 2020 年支出了 2.42 億美元的發布前庫存成本。因此，我們在 2020 年的銷售成本僅為 800 萬美元，主要包括第三方特許權使用費。如果 2020 年銷售的庫存按成本計價，我們 2020 年的銷售成本將是 6200 萬美元，占我們產品銷售額的 31%。

Research and development expenses were $759 million for Q4 2020 compared to $118 million for the same period in 2019. Research and development expenses were $1.37 billion for the full year 2020 compared to $496 million in the prior year. The increases for both 3- and 12-month periods in 2020 were mainly due to increased COVID-19 vaccine clinical development activities, headcount increases, pre-launch inventory buildup and expenses associated with the equipment and lease facilities that were deemed to have no alternative use at the acquisition of such equipment.

2020 年第四季度的研發費用為 7.59 億美元，而 2019 年同期為 1.18 億美元。2020 年全年的研發費用為 13.7 億美元，而上年為 4.96 億美元。 2020 年 3 個月和 12 個月期間的增長主要是由於 COVID-19 疫苗臨床開發活動增加、員工人數增加、發布前庫存增加以及與被認為別無選擇的設備和租賃設施相關的費用在購買此類設備時使用。

Selling, general and administration expenses were $79 million for Q4 2020 compared to $26 million for the same period in 2019. Expenses were $188 million for the full year 2020 compared to $110 million in the prior year. The increases for both periods were mainly driven by increases in personnel, outside services and start-up costs associated with preparation for commercialization of our COVID-19 vaccine globally. We recorded a net loss of $272 million for Q4 2020 compared to $123 million in the same period in 2019 and $747 million for the full year 2020 compared to $514 million in the prior year.

2020 年第四季度的銷售、一般和管理費用為 7900 萬美元，而 2019 年同期為 2600 萬美元。2020 年全年的費用為 1.88 億美元，而上一年為 1.1 億美元。這兩個時期的增長主要是由於與我們在全球範圍內將 COVID-19 疫苗商業化做準備相關的人員、外部服務和啟動成本的增加。我們在 2020 年第四季度錄得 2.72 億美元的淨虧損，而 2019 年同期為 1.23 億美元，2020 年全年淨虧損為 7.47 億美元，而上一年為 5.14 億美元。

Turning to selected cash flow information on Page 12. We ended Q4 2020 with cash and investments of $5.25 billion compared to $3.97 billion at the end of Q3. The increase is primarily driven by $1.7 billion of customer deposits received in the fourth quarter for supply of our COVID-19 vaccine.

轉到第 12 頁的選定現金流信息。我們在 2020 年第四季度末的現金和投資為 52.5 億美元，而第三季度末為 39.7 億美元。這一增長主要是由於第四季度收到了 17 億美元的客戶存款，用於供應我們的 COVID-19 疫苗。

On the top half of the page, we present information from our 10-K and 10-Q filings. And on the bottom part, we provide the quarterly trend and the cash deposits received related to supply agreements for our COVID-19 vaccine.

在頁面的上半部分，我們展示了來自 10-K 和 10-Q 文件的信息。在底部，我們提供了與 COVID-19 疫苗供應協議相關的季度趨勢和收到的現金存款。

Net cash provided by operating activities was $2.03 billion for the 12 months ended December 2020, compared to net cash used of $459 million for the same period in 2019. The reversal from cash used to cash provided by operating activities is driven by total customer deposits. Cash used for purchases of capitalized property and equipment was $67 million for the full year 2020 compared to $32 million in 2019.

截至 2020 年 12 月的 12 個月，經營活動提供的現金淨額為 20.3 億美元，而 2019 年同期使用的現金淨額為 4.59 億美元。從所用現金轉回經營活動提供的現金是由客戶存款總額推動的。 2020 年全年用於購買資本化財產和設備的現金為 6700 萬美元，而 2019 年為 3200 萬美元。

Before looking forward to 2021, let me summarize a few areas from our 2020 results that are important to keep in mind when modeling 2021 financial performance. Starting with research and development and SG&A expenses shown on the top left quadrant of Slide 13. Prior to the authorization for emergency use by the FDA and Health Canada as a pre-commercial research stage company, Moderna expensed all costs related to the production of inventory as well as costs for property and equipment and lease expenses for current and some future contract manufacturing activities due to lack of alternative use. Adjusting for these items, which in the future would be capitalized and expensed as cost of sales, the underlying R&D and SG&A expense run rate for Q4 2020 was $0.5 billion for the quarter.

在展望 2021 年之前，讓我總結一下我們 2020 年業績中的幾個領域，這些領域在對 2021 年財務業績進行建模時需要牢記。從幻燈片 13 左上象限顯示的研發和 SG&A 費用開始。在 FDA 和加拿大衛生部作為商業前研究階段公司授權緊急使用之前，Moderna 將與庫存生產相關的所有成本費用化以及由於缺乏替代用途而導致的當前和某些未來合同製造活動的財產和設備成本以及租賃費用。對這些項目進行調整，這些項目在未來將作為銷售成本資本化和支出，2020 年第四季度的基礎研發和 SG&A 費用運行率為 5 億美元。

Turning to the upper right quadrant of Slide 13. Cost of sales includes the cost of goods manufactured, logistics and warehousing costs as well as third-party royalty costs. The reported expense in Q4 of $8 million reflects the fact that we expensed all inventory-related costs until authorization of our COVID-19 vaccine. If valued at cost or actual cost of sales, including initial ramp-up costs, would have been $62 million or 31% of product sales. The cash and investment balance reported as of December 31 was $5.25 billion, $2.8 billion of which related to cash deposits from customers for future supply of our COVID-19 vaccine.

轉到幻燈片 13 的右上象限。銷售成本包括製造商品的成本、物流和倉儲成本以及第三方特許權使用費。第四季度報告的 800 萬美元費用反映了這樣一個事實，即在我們的 COVID-19 疫苗獲得授權之前，我們將所有與庫存相關的成本都計入了費用。如果按成本或實際銷售成本（包括初始提升成本）計算，將是 6200 萬美元或產品銷售額的 31%。截至 12 月 31 日報告的現金和投資餘額為 52.5 億美元，其中 28 億美元與客戶的現金存款有關，用於未來供應我們的 COVID-19 疫苗。

Lastly, let me comment on certain tax-related items. The significant investments in our research and development and start-up activities to develop the mRNA platform over the last decade has resulted in a net operating loss carryforward with the balance as of December 31, 2020, of $2.3 billion, up from $1 billion at year-end 2019. As of December 31, we maintain a full valuation allowance against our deferred tax assets related to these loss carryforwards. We will continue to monitor the valuation allowance as we progress through 2021 and expect to utilize our loss carryforwards.

最後，讓我評論一些與稅收有關的項目。在過去十年中，我們對研發和啟動活動的重大投資以開發 mRNA 平台導致淨營業虧損結轉，截至 2020 年 12 月 31 日的餘額為 23 億美元，高於去年的 10 億美元-2019 年底。截至 12 月 31 日，我們針對與這些虧損結轉相關的遞延稅項資產維持全額估值備抵。隨著我們到 2021 年的進展，我們將繼續監控估值準備金，並預計利用我們的虧損結轉。

With this context, let me now move to considerations for 2021, starting with an overview of advanced purchase agreements for our COVID-19 vaccine on Slide 14. We have disclosed advanced purchase agreements to supply our COVID-19 vaccine to 40 countries through the end of 2021, including the U.S. government for 300 million doses with options for an additional 200 million doses; the European for 310 million, with an option for an additional 150 million doses in 2022; plus 10 other countries, including Japan, Canada and South Korea, with announced doses totaling 186 million.

在此背景下，現在讓我談談對 2021 年的考慮，首先是幻燈片 14 上對我們 COVID-19 疫苗的預購協議的概述。我們已經披露了向 40 個國家供應我們的 COVID-19 疫苗的預購協議。 2021 年，包括美國政府提供 3 億劑疫苗，並可選擇額外提供 2 億劑疫苗；歐洲提供 3.1 億劑，可選擇在 2022 年再增加 1.5 億劑；加上包括日本、加拿大和韓國在內的其他 10 個國家，宣布的劑量總計 1.86 億。

We are thankful for the trust of governments around the world have placed in us to deliver a vaccine for their countries. All these agreements contain provisions for deposits and have contributed to our balance of deposits of $2.8 billion at year-end 2020. Negotiations with other countries are also ongoing, including with COVAX.

我們感謝世界各國政府對我們為他們的國家提供疫苗的信任。所有這些協議都包含存款條款，並為我們在 2020 年底的 28 億美元存款餘額做出了貢獻。與其他國家的談判也在進行中，包括與 COVAX 的談判。

Turning now to the 2021 financial framework on Slide 15. Already-signed APA agreements for expected delivery in 2021 reflect a total of $18.4 billion in anticipated product sales. Based on continuous progress to ramp up available supply capacity in our network, we have raised the lower end of our global manufacturing plan for 2021 from 600 million to 700 million doses at the 100-microgram dose level. Manufacturing is still working to supply up to 1 billion doses for 2021. Further, we expect a range of related -- of released doses in Q1 2021 of 100 million to 125 million doses and 200 million to 250 million doses in the second quarter.

現在轉向幻燈片 15 上的 2021 年財務框架。已經簽署的預計在 2021 年交付的 APA 協議反映了預計產品銷售額總計 184 億美元。基於不斷提高我們網絡中可用供應能力的進展，我們已將 2021 年全球製造計劃的下限從 100 微克劑量水平的 6 億劑提高到 7 億劑。製造業仍在努力為 2021 年供應多達 10 億劑。此外，我們預計 2021 年第一季度發布的一系列相關劑量為 1 億至 1.25 億劑，第二季度為 2 億至 2.5 億劑。

Our total cost of sales includes the cost of manufacturing, logistics and warehousing and third-party royalties, as discussed previously. For 2021, we currently model total cost of sales as a percent of product sales to be approximately 20% for the full year, with some variation quarter-by-quarter, largely driven by the average selling price. We also expect Q1 reported cost of sales in percent of product sales to be in line with the full year average, including the benefit from the remaining 0 cost prelaunch inventory in Q1.

如前所述，我們的總銷售成本包括製造、物流和倉儲成本以及第三方特許權使用費。對於 2021 年，我們目前將總銷售成本建模為全年產品銷售額的 20% 左右，每個季度都有一些變化，主要受平均售價的驅動。我們還預計第一季度報告的銷售成本佔產品銷售額的百分比將與全年平均水平一致，包括第一季度剩餘的 0 成本發布前庫存帶來的收益。

Now let me comment on planned R&D and SG&A expenses. The underlying Q4 2020 expense run rate, adjusted for transitional items as discussed on Slide 13, was approximately $0.5 billion. We currently expect our quarterly reported expenses to increase on a continuous basis through 2021 compared to the Q4 2020 adjusted run rate. In Q1, we expect an increase in the low double-digit percentage range relative to the adjusted Q4 2020 expense run rate of $0.5 billion. We will provide additional updates going forward as our global business rapidly expands.

現在讓我評論一下計劃中的研發和 SG&A 費用。根據幻燈片 13 討論的過渡項目調整後的 2020 年第四季度基本費用運行率約為 5 億美元。我們目前預計，與 2020 年第四季度調整後的運行率相比，到 2021 年，我們的季度報告費用將持續增加。與調整後的 2020 年第四季度 5 億美元的費用運行率相比，我們預計第一季度的低兩位數百分比範圍會有所增加。隨著我們全球業務的快速擴張，我們將在未來提供更多更新。

I would also like to comment on how we think about modeling our tax rate. In 2021, Moderna will transition to taxpaying status as we deliver on our COVID-19 vaccine contracts to customers. As a U.S.-based company, we start with the statutory 21% tax rate. This is impacted by global sales mix to the extent that non-U.S. rates are generally lower than in the U.S and by recovery against our prior accumulated losses of over $2 billion. As we start the year, we expect the all-in 2021 tax rate to be in the mid-teen percentage level on an ongoing basis, including in the first quarter. We will update this view as our book of business evolves further.

我還想評論一下我們如何看待我們的稅率建模。 2021 年，隨著我們向客戶交付 COVID-19 疫苗合同，Moderna 將轉變為納稅狀態。作為一家美國公司，我們從 21% 的法定稅率開始。這受到全球銷售組合的影響，非美國費率普遍低於美國，而且我們之前的累計虧損超過 20 億美元。在今年開始之際，我們預計 2021 年的全部稅率將持續保持在青少年百分比水平，包括第一季度。隨著我們業務的進一步發展，我們將更新這一觀點。

Lastly, regarding capital investments. We currently plan capital investment in the amount of $350 million to $400 million for 2021. Roughly half of the investment is to further expand our COVID-19 vaccine supply capability, including supply capacity up to 1.4 billion doses at the 100-microgram level, with the balance of planned capital investments to expand our technical development, clinical manufacturing as well as our other facility footprint.

最後，關於資本投資。我們目前計劃在 2021 年進行 3.5 億至 4 億美元的資本投資。大約一半的投資用於進一步擴大我們的 COVID-19 疫苗供應能力，包括在 100 微克水平上提供高達 14 億劑疫苗的能力，其中計劃資本投資的餘額，以擴大我們的技術開發、臨床製造以及我們的其他設施足跡。

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

我對財務業績的評論到此結束，我將電話轉回給 Stéphane。

Thank you, David. Let me now discuss 2021 on Slide 17. We are still in February, and the Moderna COVID-19 vaccine is now authorized in 37 countries, and our team is continuing to engage regulators in new geographies, like Japan, Taiwan, the Philippines and more. We're also well on our way in the rolling submission process to the WHO, which will be key for low-income countries access via COVAX and UNICEF if we get the partnership done.

謝謝你，大衛。現在讓我在幻燈片 17 上討論 2021 年。我們仍處於 2 月，Moderna COVID-19 疫苗現已在 37 個國家/地區獲得授權，我們的團隊正在繼續與日本、台灣、菲律賓等新地區的監管機構合作.我們也在向世衛組織滾動提交過程中進展順利，如果我們完成夥伴關係，這將是低收入國家通過 COVAX 和聯合國兒童基金會訪問的關鍵。

We are committed to our principles of global access to our new class of medicines, where we recognize that the need for scale up of manufacturing operations have led to supply going to the U.S., Europe and other countries. We are working with COVAX to provide low-cost vaccines to the poorest countries and look forward to supplying our vaccines for COVAX Gavi and becoming a company that will be part of the global health infrastructure for many years to come. UNICEF is the procurement arm of COVAX.

我們致力於在全球範圍內獲得我們的新型藥物的原則，我們認識到擴大製造業務的需求導致供應流向美國、歐洲和其他國家。我們正在與 COVAX 合作，為最貧窮的國家提供低成本疫苗，並期待為 COVAX Gavi 提供我們的疫苗，並成為未來許多年成為全球衛生基礎設施一部分的公司。聯合國兒童基金會是 COVAX 的採購部門。

On Slide 18. As I shared in my 2020 shareholder letter, which we posted publicly on January 4 and which you can access on our blog if you have not read it, I believe that 2021 is going to be the most important inflection year in Moderna's history. You can see the evolution of the company over 2019, 2020 and 2021 on this slide over a few dimensions. But to me, the reason I say that 2021 is the most important inflection year in the company's history, is that we are not the same company. As I've told our employees in a recent town hall, I almost wished I could change the company name to help our team understand the magnitude of the change.

在幻燈片 18 上。正如我在 2020 年股東信中所分享的那樣，我們於 1 月 4 日公開發布了這封信，如果您尚未閱讀，您可以在我們的博客上訪問，我相信 2021 年將是 Moderna 最重要的轉折年歷史。您可以在這張幻燈片上從幾個方面看到公司在 2019 年、2020 年和 2021 年的演變。但對我來說，我之所以說 2021 年是公司歷史上最重要的轉折年，是因為我們不是同一家公司。正如我在最近的一次市政廳告訴我們的員工一樣，我幾乎希望我可以更改公司名稱，以幫助我們的團隊了解更改的幅度。

We used to believe that mRNA vaccine could be authorized and become commercial. We used to have negative cash flows from operations each quarter since our founding in 2010. We used to work to raise additional capital regularly and thought we needed to do that for another 5 plus years until CMV will get the company's cash flow breakeven. But we have been through an incredible pivot. This is not the same company.

我們曾經相信 mRNA 疫苗可以被授權並商業化。自 2010 年成立以來，我們每個季度的運營現金流都為負數。我們過去常常努力籌集額外的資金，並認為我們需要再做 5 年多的時間，直到 CMV 實現公司的現金流盈虧平衡。但我們經歷了一個令人難以置信的轉變。這不是同一家公司。

Now we know that mRNA vaccine can be authorized and become commercial. Now we have positive cash flows from operations for 2 quarters in a row already. So now we are going to double down on our investment in science, in process development, in manufacturing, in IT, in robotics, in AI to scale our company.

現在我們知道mRNA疫苗可以被授權並商業化。現在我們已經連續兩個季度從運營中獲得正現金流。因此，現在我們將加倍在科學、工藝開發、製造、IT、機器人和人工智能方面的投資，以擴大我們的公司規模。

I believe that in business, there's a drastic difference between believing in an outcome and having negative cash flow versus knowing an outcome and having positive cash flow. Our appetite and our ability to invest has been transformed. We are not the same company now that we were in the last 10 years. Our thinking is going to be much more expansive.

我相信在商業中，相信結果並擁有負現金流與知道結果並擁有正現金流之間存在巨大差異。我們的胃口和投資能力已經改變。我們現在與過去 10 年的公司不同。我們的思維將更加廣闊。

On Slide 19. As David shared a moment ago, we have, as of yesterday, already $18.4 billion of signed advanced purchase agreements for fiscal year 2021 deliveries. We still have multiple discussions ongoing about additional APAs for 2021. So these have not been signed yet, so they are not counted in the $18.4 billion. We'll update you each quarter about the signed APAs for fiscal year 2021 as we report sales recognized with the shipment of our COVID-19 vaccine.

在幻燈片 19 上。正如大衛剛才分享的那樣，截至昨天，我們已經簽署了 184 億美元的 2021 財年交付預購協議。我們仍在就 2021 年的其他 APA 進行多次討論。因此這些尚未簽署，因此未計入 184 億美元。我們將在每個季度向您更新已簽署的 2021 財年 APA，因為我們報告了我們的 COVID-19 疫苗發貨確認的銷售額。

We increased our manufacturing base plan for the year to 700 million doses and are working hard to get to 1 billion. We are working with COVAX and its procurement arm, UNICEF, to maximize the availability of our vaccine around the world.

我們將今年的生產基地計劃增加到 7 億劑，並正在努力達到 10 億劑。我們正在與 COVAX 及其採購部門 UNICEF 合作，以最大限度地提高我們在全球範圍內的疫苗供應。

Let me now turn to Slide 20 to talk about 2022 manufacturing capacity. We announced last night after the market closed that several factors have led us to decide to add more manufacturing capacity. First, many governments have been telling us that they now see 2 classes of COVID-19 vaccine based on efficacy, and they would like more of our vaccine given its high efficacy. Second, variants. Government and political leaders around the world are concerned about the emergence of several variants. They have been very clear about it, and some of them have started to request options for 2022.

現在讓我轉到幻燈片 20 來談談 2022 年的製造能力。我們昨晚在市場收盤後宣布，有幾個因素導致我們決定增加更多的製造能力。首先，許多政府一直在告訴我們，他們現在看到了基於功效的 2 類 COVID-19 疫苗，鑑於其高效，他們希望獲得更多我們的疫苗。二、變種。世界各地的政府和政治領導人都在關注幾種變體的出現。他們已經很清楚了，其中一些已經開始要求 2022 年的選項。

With the start of the fall season soon in the southern hemisphere, with a large population of the world and with a large population of immune-compromised patients, like HIV-positive patients, we're hearing daily that governments around the world and the COVID teams worry that boosting people with variants will be an important strategy over the next couple of years to get this virus under control.

隨著南半球秋季即將開始，世界人口眾多，免疫功能低下的患者人數眾多，例如 HIV 陽性患者，我們每天都聽到世界各國政府和 COVID團隊擔心，在未來幾年內，增加攜帶變異的人將是控制這種病毒的重要策略。

So we decided to add manufacturing capacity. We have communicated previously that our capacity for 2022, given the ramp in 2021, will be approximately up to 1.2 billion doses, assuming 100-microgram dose. We have decided and have started to buy additional capital equipment, hire more people and order more raw materials towards 200 million doses per year of capacity for 2022. So if you assume a 100-microgram dose, we will have 1.4 billion dose of capacity for fiscal year '22. In other words, we will build the manufacturing capacity to make up to 140 kilograms, yes, kilograms, of formulated mRNA in 2022.

所以我們決定增加製造能力。我們之前曾溝通過，假設 100 微克劑量，考慮到 2021 年的增長，我們 2022 年的產能將約為 12 億劑。我們已經決定並開始購買額外的資本設備，僱用更多的員工並訂購更多的原材料，以實現 2022 年每年 2 億劑的產能。因此，如果你假設 100 微克的劑量，我們將有 14 億劑的產能'22財政年度。換句話說，我們將在 2022 年建立製造能力，以製造多達 140 公斤，是的，公斤的 mRNA。

Now let's talk about output in number of doses. Two factors determine output: the dose of a boost; and the product mix. Given our COVID-19 vaccine, previously referred as mRNA-1273, is currently authorized for 100-microgram dose. So with using the boost like mRNA-1273.351, the South African variant candidate, needs 50 microgram per dose. On the bottom left of the slide, you see a scenario in which 100% of our output is our COVID-19 vaccine authorized, and we get 1.4 billion doses at 100 microgram. On the bottom in the middle, you see a scenario where we sell 1 billion doses for COVID-19 authorized vaccine and 0.8 billion doses for boost at 50 microgram for a total of 1.8 billion doses. And on the bottom right, you see the marks and -- another scenario on the right.

現在讓我們談談劑量數的輸出。兩個因素決定輸出：加強劑量；和產品組合。鑑於我們的 COVID-19 疫苗（以前稱為 mRNA-1273）目前已獲得 100 微克劑量的授權。因此，使用像 mRNA-1273.351（南非變體候選）這樣的增強劑，每劑需要 50 微克。在幻燈片的左下角，您會看到我們的產出 100% 是我們授權的 COVID-19 疫苗，我們獲得了 14 億劑 100 微克的疫苗。在中間的底部，您會看到我們銷售 10 億劑 COVID-19 授權疫苗和 8 億劑 50 微克的加強疫苗，總共 18 億劑。在右下角，你會看到標記和-- 右邊的另一個場景。

The way to think about output will depend on the dose of the boost and the product mix. We will learn in the next few months in the clinic about the necessary dose to get a high neutralizing antibody titer for our boost. Only, one needs to think about our manufacturing capacity in terms of mass. Given the flexibility of mRNA, we can, in the same room and with the same equipment, make COVID-19 vaccine and/or 1 boost, and/or are 2 boosts, and/or 3 boosts, you get the point. We can run manufacturing campaign based on the market demand with the same manufacturing capacity, just like small molecule drug substance.

考慮產出的方式將取決於提升的劑量和產品組合。在接下來的幾個月裡，我們將在診所了解獲得高中和抗體滴度以進行增強所需的必要劑量。只是，我們需要從質量的角度來考慮我們的製造能力。鑑於 mRNA 的靈活性，我們可以在同一個房間和使用相同的設備，製造 COVID-19 疫苗和/或 1 次加強，和/或 2 次加強，和/或 3 次加強，你明白了。我們可以根據市場需求以相同的製造能力進行製造活動，就像小分子藥物一樣。

So with mRNA, we not only have the advantage of speed, but we also have the advantage of manufacturing flexibility and we have best-in-class efficacy. I believe this will prove crucial from a competitive standpoint for the years ahead, where nobody knows where the demand mix will have to be. It's a new and still unstable virus. Nobody knows if 1 variant is going to be necessary and/or enough to boost or more in the years to come until this virus is fully under control.

因此，對於 mRNA，我們不僅具有速度優勢，而且還具有製造靈活性的優勢，並且具有一流的功效。我相信，從競爭的角度來看，這對於未來幾年至關重要，因為沒有人知道需求組合必須在哪裡。這是一種新的並且仍然不穩定的病毒。在這種病毒完全得到控制之前，沒有人知道在未來幾年中是否有必要和/或足以增強或更多的變體。

So speed to market and flexibility of product mix and scale will be critical. We have all three. Few companies do. And we also, without the partners, we don't have to get aligned with somebody else with different goals, different financial incentives, different corporate decision-making process, different culture. We have moved fast, and we will continue to move fast.

因此，產品組合和規模的上市速度和靈活性將至關重要。我們三個都有。很少有公司這樣做。而且，如果沒有合作夥伴，我們也不必與具有不同目標、不同財務激勵、不同公司決策過程、不同文化的其他人保持一致。我們已經快速行動，我們將繼續快速行動。

On Slide 21. In 2021, we are continuing to scale our commercial network. We plan to open commercial subsidiaries this year in Japan, South Korea and Australia. I look forward to planting the Moderna flag in Tokyo, Seoul and Sydney. We also want to continue to help regional distributors. We are in advanced discussions with partners to cover ASEAN and also Eastern Europe. With this addition in 2021, we will have a strong commercial network across the world in most critical markets by the end of this year.

在幻燈片 21 上。2021 年，我們將繼續擴展我們的商業網絡。我們計劃今年在日本、韓國和澳大利亞開設商業子公司。我期待在東京、首爾和悉尼插上摩德納的旗幟。我們也想繼續幫助區域經銷商。我們正在與合作夥伴進行深入討論，以涵蓋東盟和東歐。隨著 2021 年的加入，到今年年底，我們將在全球最關鍵的市場擁有強大的商業網絡。

On the next slide, we were delighted to announce earlier this year that Corinne Le Goff has joined as Moderna's first Chief Commercial Officer. Corinne's experience in global commercial leadership, until recently at Amgen, but also her critical experience as Country Manager at Roche and her experience with digital marketing will prove invaluable.

在下一張幻燈片中，我們很高興在今年早些時候宣布 Corinne Le Goff 已加入 Moderna 擔任首位首席商務官。 Corinne 直到最近在 Amgen 的全球商業領導經驗，以及她在羅氏 (Roche) 擔任國家經理的重要經驗以及她在數字營銷方面的經驗將被證明是無價的。

I have had the chance to spend a lot of time with Corinne since she joined, and I'm confident she will build a Moderna commercial organization highly leveraged with digital solutions, both externally and internally. We both share the view that there are many ways to run commercial operation in a much more modern way than traditional sales force of large pharmaceutical companies. In commercial, too, Moderna will disrupt and innovate and implement best practices from many industries and build a digital commercial organization. Corinne will have a chance to share some her thoughts and present to you at our Vaccine Day on April 14.

自從 Corinne 加入以來，我有機會和她一起度過了很多時間，我相信她將建立一個 Moderna 商業組織，在外部和內部都高度利用數字解決方案。我們都認為，與大型製藥公司的傳統銷售隊伍相比，有很多方法可以以更現代的方式進行商業運營。在商業方面，Moderna 也將顛覆和創新並實施許多行業的最佳實踐，並建立一個數字商業組織。 Corinne 將有機會在 4 月 14 日的疫苗日分享她的一些想法並向您展示。

This morning, we also announced that Tal, our Chief Medical Officer, will be leaving the company in late September after 6 years of service. Tal joined us when we were a preclinical company and now we have our first authorized product. I am very thankful for Tal for taking a chance on us 6 years ago. It was not obvious at the time, trust me, that we were going to make it. But given his deep scientific understanding and curiosity like Stephen Hoge and I and many others on the team, he saw that this technology could change medicine if we could make it work safely in humans.

今天上午，我們還宣布，我們的首席醫療官 Tal 在服務了 6 年後將於 9 月底離開公司。當我們還是一家臨床前公司時，Tal 加入了我們，現在我們擁有了我們的第一個授權產品。我非常感謝 Tal 在 6 年前給我們一個機會。相信我，當時並不明顯，我們會成功。但考慮到他對科學的深刻理解和好奇心，就像 Stephen Hoge 和我以及團隊中的許多其他人一樣，他看到如果我們能讓這項技術安全地在人類身上發揮作用，這項技術就可以改變醫學。

Tal, thank you so much for everything you have done. It has been a pleasure of building Moderna with you and the team. I look forward to continuing working with you in the coming quarters.

塔爾，非常感謝你所做的一切。很高興與您和團隊一起建立 Moderna。我期待在接下來的幾個季度繼續與您合作。

The company has retained Russell Reynolds to recruit a new Chief Medical Officer with global and commercial experience as the company scale up to launch the COVID-19 vaccine, of course, around the world, also prepares for potential COVID boost and prepares to file several biological license over the next few years.

隨著公司擴大規模以推出 COVID-19 疫苗，該公司已聘請 Russell Reynolds 招募具有全球和商業經驗的新首席醫療官，當然，在全球範圍內，也為潛在的 COVID 推廣做準備，並準備提交幾個生物未來幾年的執照。

With this, now let me turn to Stephen to talk about SARS-CoV-2 variants. Stephen?

有了這個，現在讓我轉向斯蒂芬談談 SARS-CoV-2 變體。斯蒂芬?

Thank you, Stéphane, and good morning, everyone. Today, I want to take you through our current thinking on variance and our strategy to address them. I'll then turn it over to Tal to provide an update on our pipeline.

謝謝你，Stéphane，大家早上好。今天，我想帶你了解我們目前對差異的思考以及我們解決這些問題的策略。然後，我會將其交給 Tal，以提供有關我們管道的更新。

Let me start with a quick overview of our strategy for SARS-CoV-2 variance of concern. Last week, we published a letter in The New England Journal of Medicine with data that confirmed the Moderna COVID-19 vaccine, mRNA-1273, provides neutralizing activity against all variants of concern tested to date. Nonetheless, as recent reports have increased transmission and potential reinfections of the new variants have emerged, out of an abundance of caution, we have announced multiple strategies to try to increase protection against those variants.

讓我先快速概述一下我們對 SARS-CoV-2 關注差異的策略。上週，我們在《新英格蘭醫學雜誌》上發表了一封信，其中的數據證實 Moderna COVID-19 疫苗 mRNA-1273 對迄今為止測試的所有關注變體具有中和活性。儘管如此，隨著最近的報導增加了傳播，並且出現了新變體的潛在再感染，出於謹慎考慮，我們宣布了多種策略來嘗試增加對這些變體的保護。

As has been widely reported, the immune response generated by original strains appears to be relatively weaker against the B.1.351 variant. If or when immunity wanes in the future, this might lead to a gap in protection. We plan to close this potential gap with an update to our vaccine based on the new strains. We anticipate different approaches for 2 distinct populations.

正如廣泛報導的那樣，原始菌株產生的免疫反應似乎對 B.1.351 變體相對較弱。如果將來或當免疫力減弱時，這可能會導致保護方面的空白。我們計劃通過更新基於新毒株的疫苗來彌補這一潛在差距。我們預計針對 2 個不同人群的不同方法。

For those who have been immunized or infected by the original strains, we anticipate boosting with a variant-specific booster vaccine, either alone or in combination with our vaccine against the ancestral strains. For those who are still naive to SARS-CoV-2 because they have not been previously infected or vaccinated, we anticipate updating our vaccine to provide immunity to both the ancestral strains and the new variants of concern.

對於那些已經免疫或被原始毒株感染的人，我們預計單獨使用或與我們針對祖先毒株的疫苗聯合使用變體特異性加強疫苗進行加強免疫。對於那些因為之前沒有被感染或接種過 SARS-CoV-2 而仍然對 SARS-CoV-2 不熟悉的人，我們預計會更新我們的疫苗，以提供對祖先菌株和關注的新變種的免疫力。

Now on Slide 25, you can see the clinical trials that are ongoing or planned for our COVID-19 vaccines. For mRNA-1273, the TeenCOVE Phase II/III study in adolescents ages 12 to 17 years is ongoing and recently completed enrollment. The KidCOVE study, Phase II, in pediatric populations ages 6 months to 11 years, will begin in the near term. And our Phase I/II study in Japan is ongoing, led by our partner, Takeda.

現在在幻燈片 25 上，您可以看到我們的 COVID-19 疫苗正在進行或計劃進行的臨床試驗。對於 mRNA-1273，針對 12 至 17 歲青少年的 TeenCOVE II/III 期研究正在進行中，最近完成了註冊。 KidCOVE 研究 II 期針對 6 個月至 11 歲的兒科人群，將於近期開始。我們在日本的 I/II 期研究正在進行中，由我們的合作夥伴武田 (Takeda) 領導。

For the variant studies, we plan to test a variant-specific booster candidate, mRNA-1273.351 based on the B.1.351 variant, first identified in the Republic of South Africa at the 50-microgram dose level and lower. In addition, we plan to test a multivalent booster candidate, mRNA-1273.211 that combines mRNA-1273 and mRNA-1273.351 in a single vaccine, again at the 50-microgram dose level and lower. And we're also evaluating a third dose of our authorized Moderna COVID-19 vaccine, mRNA-1273, at a 50-microgram dose level, which is already underway.

對於變體研究，我們計劃測試基於 B.1.351 變體的變體特異性增強候選物 mRNA-1273.351，該變體首次在南非共和國以 50 微克及更低的劑量水平發現。此外，我們計劃測試一種多價增強候選物 mRNA-1273.211，它在單一疫苗中結合了 mRNA-1273 和 mRNA-1273.351，同樣在 50 微克或更低的劑量水平。我們還在評估我們授權的 Moderna COVID-19 疫苗 mRNA-1273 的第三劑，劑量為 50 微克，該疫苗已經在進行中。

Finally, we are planning to test the next-generation vaccine, mRNA-1283 that encodes for the receptor binding domain and end terminal domain of the spike protein and is being developed as a potential refrigerator stable mRNA vaccine that could facilitate easier distribution and administration in a wider range of settings, including potentially developing countries.

最後，我們計劃測試下一代疫苗 mRNA-1283，它編碼刺突蛋白的受體結合結構域和末端結構域，並且正在開發為一種潛在的冰箱穩定 mRNA 疫苗，可以促進更容易在更廣泛的環境，包括潛在的發展中國家。

We believe messenger RNA is best positioned to address the potential threat of SARS-CoV-2 variance, given several key characteristics, including high vaccine efficacy, speed and agility to make updates, ease with which we can do combinations and our manufacturing flexibility and scalability. I'm happy to say that we have already manufactured the first GMP batch of our variant booster candidate, mRNA-1273.351, and have shipped clinical trial material to the NIH for clinical testing.

我們認為信使 RNA 最適合解決 SARS-CoV-2 變異的潛在威脅，因為它有幾個關鍵特徵，包括疫苗效力高、更新的速度和敏捷性、我們可以輕鬆地進行組合以及我們的製造靈活性和可擴展性.我很高興地說，我們已經生產了第一批 GMP 批次的變異增強劑候選藥物 mRNA-1273.351，並將臨床試驗材料運送到 NIH 進行臨床測試。

Now I'll hand it over to Tal, who will walk you through the rest of our portfolio across vaccines and therapeutics. Tal?

現在我將把它交給 Tal，他將引導您了解我們在疫苗和治療方面的其他產品組合。塔爾？

Thank you, Stephen. So let me briefly summarize where we are in the rest of our pipeline. With 4 other vaccine programs that are in clinical trials, the CMV vaccine is on track to start the pivotal Phase III this year. The Zika vaccine is preparing for a Phase II trial that is also expected to begin in this year. And our hMPV/PIV3 vaccine is currently enrolling in toddlers. Our RSV vaccine is being studied in 2 separate trials, 1 in children and 1 in adults. The pediatric trial is enrolling quickly, and the first 3 cohorts in the age de-escalation study have now been fully enrolled. We announced last month that we were taking our RSV vaccine into the adult population, and I'm happy to share that the first participant has since then been dosed in that trial.

謝謝你，斯蒂芬。因此，讓我簡要總結一下我們在其餘管道中的位置。隨著其他 4 個疫苗項目正在進行臨床試驗，CMV 疫苗有望在今年啟動關鍵的 III 期。寨卡疫苗正在為預計將於今年開始的 II 期試驗做準備。我們的 hMPV/PIV3 疫苗目前正在招募幼兒。我們的 RSV 疫苗正在 2 項獨立試驗中進行研究，1 項針對兒童，1 項針對成人。兒科試驗正在迅速招募，年齡降級研究的前 3 個隊列現已全部招募。我們上個月宣布，我們正在將 RSV 疫苗用於成年人群，我很高興地分享，自那以後，第一位參與者已經在該試驗中接種了疫苗。

Just last month, we announced 3 new development programs in infectious disease vaccines. Our influenza vaccine program will evaluate 3 candidates comprising multiple antigen combinations against the 4 seasonal viruses recommended by the WHO, eventually moving 1 candidate into a Phase III trial.

就在上個月，我們宣布了 3 個傳染病疫苗的新開發計劃。我們的流感疫苗計劃將評估 3 種候選疫苗，包括針對 WHO 推薦的 4 種季節性病毒的多種抗原組合，最終將 1 種候選疫苗轉入 III 期試驗。

Our HIV vaccine program has 2 approaches. mRNA-1644 is a collaboration with IAVI and the Bill and Melinda Gates foundation. It's a novel approach to an HIV vaccine strategy that's designed to elicit broadly neutralizing HIV-1 antibodies. mRNA-1574 is a collaboration with the NIH, and this includes multiple native-like trimer antigens.

我們的 HIV 疫苗計劃有兩種方法。 mRNA-1644 是與 IAVI 和比爾和梅琳達·蓋茨基金會的合作項目。這是一種新的 HIV 疫苗策略方法，旨在引發廣泛的中和 HIV-1 抗體。 mRNA-1574 是與 NIH 的合作項目，其中包括多種類似天然的三聚體抗原。

And finally, for those unfamiliar with the Nipah virus, this is a zoonotic virus transmitted to humans from animals, that is either transmitted in food or through direct human-to-human transmission. It is included in the WHO R&D blueprint list of epidemic threats needed for urgent R&D action. mRNA-1215 is a collaboration with the NIH to develop a Nipah vaccine.

最後，對於那些不熟悉尼帕病毒的人來說，這是一種人畜共患病毒，由動物傳播給人類，要么通過食物傳播，要么通過直接人傳人的方式傳播。它被列入世衛組織緊急研發行動所需的流行病威脅研發藍圖清單。 mRNA-1215 是與 NIH 合作開發的 Nipah 疫苗。

We also have 7 clinical proof-of-concept trials ongoing in our exploratory modalities. The Phase II program in VEGF, partnered with AstraZeneca, is ongoing. The personalized cancer vaccine Phase II, which is in combination with KEYTRUDA compared to KEYTRUDA alone, that is partnered with Merck continues. And the Phase I of that program in multiple cohorts is ongoing, including the upsized head and neck cohort that is currently recruiting additional patients.

我們還在探索模式中進行了 7 項臨床概念驗證試驗。與阿斯利康合作的 VEGF II 期項目正在進行中。與默克（Merck）公司合作的個性化癌症疫苗 II 期（與 KEYTRUDA 單獨使用相比，與 KEYTRUDA 聯合使用）繼續進行。該計劃的多個隊列的第一階段正在進行中，包括目前正在招募更多患者的大型頭頸部隊列。

The KRAS Phase I that is partnered with Merck continues. And in the intratumoral oncology, we have a Phase II ongoing with OX40 ligand program in ovarian cancer patients. The Phase I dose escalation for the triplet program is ongoing both as monotherapy and in combination with durvalumab. And IL-12 partnered with AstraZeneca continues in a Phase I trial. Finally, within the systemic intracellular therapeutics, the Phase I/II sites for our PA program are being initiated, and we plan to enter the clinic this year.

與默克合作的 KRAS Phase I 繼續進行。在腫瘤內腫瘤學方面，我們正在進行針對卵巢癌患者的 OX40 配體計劃的 II 期研究。三聯療法的 I 期劑量升級正在作為單一療法和與 durvalumab 聯合使用。與阿斯利康合作的 IL-12 繼續進行 I 期試驗。最後，在系統性細胞內治療中，我們的 PA 計劃的 I/II 期站點正在啟動，我們計劃今年進入臨床。

This final slide has our full pipeline. And with that, let me hand it back to Stéphane.

最後一張幻燈片有我們完整的管道。有了這個，讓我把它交還給 Stéphane。

Thank you, Tal. On Slide 32. We have a set of clear priorities for 2021, and everybody at Moderna has had a chance to review them and to discuss them.

謝謝你，塔爾。在幻燈片 32 上。我們為 2021 年制定了一系列明確的優先事項，Moderna 的每個人都有機會對其進行審查和討論。

Priority #1, to maximize the impact of our COVID-19 vaccine. The output in 2021 in terms of number of dose that we can ship to countries, the manufacturing scale-up, preparing for 2022 supply, clinical development of variants and boost, and our full commitment to bring variants of concern to the clinic. Priority #2, accelerate vaccine development and continue to bring more innovation from a research lab to clinical development.

優先事項 #1，最大限度地發揮我們 COVID-19 疫苗的影響。 2021 年的產量，包括我們可以運送到各國的劑量、製造規模擴大、為 2022 年的供應做準備、變體和增強的臨床開發，以及我們將關注的變體帶到臨床的全面承諾。優先事項 #2，加快疫苗開發並繼續將更多創新從研究實驗室帶到臨床開發。

Priority #3, generate proof-of-concept in therapeutics, based on the success of our ability to repeat dose in human of therapeutics technology with chikungunya antibodies. But also with intratumoral, we expect key data in cardiology, oncology, rate genetic disease and the entry in the clinic of our first autoimmune programs. Priority #4, we want to continue the expansion of mRNA technology. Our appetite to invest in science and process development has not weakened, just the opposite. We believe we are still at the beginning of the S-curve of this exciting new disruptive technology.

優先事項 #3，基於我們成功地利用基孔肯雅抗體在人體中重複給藥治療技術的能力，生成治療學的概念驗證。但對於腫瘤內，我們期待心髒病學、腫瘤學、遺傳疾病率以及我們的第一個自身免疫項目進入臨床的關鍵數據。優先事項 #4，我們希望繼續擴展 mRNA 技術。我們對科學和工藝開發的投資慾望並沒有減弱，恰恰相反。我們相信我們仍處於這一令人興奮的新顛覆性技術的 S 曲線的開端。

On Slide 33, as I shared earlier, this is an important inflection year for the company, now that we know that mRNA vaccine can be approved, that we have positive cash flow, we have the ability to invest and to scale like we've never had in our history.

在幻燈片 33 上，正如我之前分享的那樣，這對公司來說是一個重要的轉折年，現在我們知道 mRNA 疫苗可以獲得批准，我們有正現金流，我們有能力像我們一樣進行投資和擴大規模在我們的歷史上從未有過。

If you look at Slide 34, you see some of the key attributes that energized me. mRNA is an information molecule, Moderna has a unique platform. We have a very strong cash position. We have signed very large amount of APAs. We believe Moderna will be cash flow positive this year. We believe Moderna will be profitable in 2021. The team has done a remarkable job, and I'm so proud of this team. We have a fully integrated manufacturing plant in Massachusetts and the network of partners with Lonza, Catalent, ROVI, (inaudible). We have already made 100 million doses of drug substance of the COVID-19 vaccine. We have shipped approximately 60 million doses globally. And as the team reviewed, we have 24 exciting first-in-class or best-in-class development programs that we are pushing towards the clinic -- sorry, for approval.

如果您查看幻燈片 34，您會看到一些讓我充滿活力的關鍵屬性。 mRNA是一種信息分子，Moderna有一個獨特的平台。我們擁有非常強大的現金頭寸。我們已經簽署了大量的預約定價安排。我們相信 Moderna 今年的現金流將是正數。我們相信 Moderna 將在 2021 年實現盈利。該團隊做得非常出色，我為這支團隊感到驕傲。我們在馬薩諸塞州擁有一個完全集成的製造工廠，並與 Lonza、Catalent、ROVI（聽不清）建立了合作夥伴網絡。我們已經生產了 1 億劑 COVID-19 疫苗的原料藥。我們已經在全球運送了大約 6000 萬劑。正如團隊審查的那樣，我們有 24 個令人興奮的一流或一流的開發計劃，我們正在向臨床推進——抱歉，需要批准。

As our historic investors know, since I've joined Moderna as employee #2 in 2011, we have always focused on how do we grow 10x from where we are. We ask this question to ourselves regularly. I have to admit that in 2020, I did not focus on it as intensely as in the previous years. We were focused on moving mRNA-1273 to Phase I, Phase II, Phase III regulatory authorization and on building manufacturing to deliver up to 1 billion doses for 2021.

正如我們歷史悠久的投資者所知，自從我在 2011 年作為 2 號員工加入 Moderna 以來，我們一直專注於如何實現 10 倍的增長。我們經常問自己這個問題。我不得不承認，在 2020 年，我並沒有像往年那樣專注於它。我們專注於將 mRNA-1273 轉移到 I 期、II 期、III 期監管授權，並致力於建立製造以在 2021 年交付多達 10 億劑。

We did not spend much time asking how do we grow 10x? We were focused on how do we get this important vaccine to the finish line and get up to 1 billion dose to help people around the world. In early December, while our team was focused on preparing for FDA VRBPAC meeting on December 17, I was starting to step back and engaged with the Board and some of our executive team members and asked all of them, "Now that we know mRNA vaccine can get approved and that we are generating cash, how do we grow 10x from here?"

我們沒有花太多時間問我們如何增長 10 倍？我們專注於如何讓這種重要的疫苗達到終點，並獲得多達 10 億劑疫苗來幫助世界各地的人們。 12 月初，當我們的團隊專注於為 12 月 17 日的 FDA VRBPAC 會議做準備時，我開始退後一步，與董事會和我們的一些執行團隊成員進行接觸，並問他們所有人，“現在我們知道了 mRNA 疫苗可以獲得批准並且我們正在產生現金，我們如何從這裡增長 10 倍？”

The last 2 months have been really fun to invent that 10x Moderna. The team is highly energized by it and so am I. We have the opportunity to become one of the most impactful biopharmaceutical company over the next 10 to 20 years in the world. The potential to maximize that impact on patients is what motivates us.

過去 2 個月發明 10 倍 Moderna 真的很有趣。團隊為此而充滿活力，我也是。我們有機會在未來 10 到 20 年成為世界上最具影響力的生物製藥公司之一。最大限度地提高對患者的影響的潛力是我們的動力。

The team and I look forward to welcoming you to our regular investor events. We will host our Vaccine Day on April 14. We will host our annual Science Day on May 27. And we will host our annual R&D Day on September 9.

我和團隊期待著歡迎您參加我們的定期投資者活動。我們將在 4 月 14 日舉辦疫苗日。我們將在 5 月 27 日舉辦一年一度的科學日。我們將在 9 月 9 日舉辦一年一度的研發日。

More than ever, we have a unique opportunity to have a very large impact on so many lives. This is humbling to all of us and also highly motivating to always challenge ourselves to build the best version of Moderna that we can. I would like to thank our Moderna team, our partners, our many suppliers around the world, our clinical investigators, our participants in our clinical studies. I would also like to thank our investors for your trust as we embark in this new version of Moderna.

我們比以往任何時候都更有機會對這麼多人的生活產生非常大的影響。這對我們所有人來說都是謙卑的，也非常有動力不斷挑戰自己，盡我們所能打造最好的 Moderna。我要感謝我們的 Moderna 團隊、我們的合作夥伴、我們在世界各地的眾多供應商、我們的臨床研究人員以及我們臨床研究的參與者。我還要感謝我們的投資者在我們著手這個新版本的 Moderna 時的信任。

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

我和團隊現在很樂意回答您的問題。操作員？

(Operator Instructions) Your first question comes from the line of Matthew Harrison with Morgan Stanley.

（操作員說明）您的第一個問題來自摩根士丹利的 Matthew Harrison。

I guess, first question, can you discuss the dosing strategy around boosting. And in particular, I think I understand why you're going to start with 50 micrograms, but what you think about the probability of using a lower dose there.

我想，第一個問題，你能討論一下關於加強的劑量策略嗎？特別是，我想我理解你為什麼要從 50 微克開始，但是你對在那裡使用較低劑量的可能性的看法。

And then just secondly, as far as I understand, I think the number of doses that have been signed via APA are higher than the 700 million that you've talked about in terms of manufacturing supply. Can you just talk about what your thoughts are in being able to deliver those additional doses this year?

其次，據我了解，我認為通過 APA 簽署的劑量數量高於您所說的製造供應方面的 7 億劑。你能談談你對今年能夠提供這些額外劑量的想法嗎？

Go ahead, Stephen.

來吧，斯蒂芬。

I'll take the -- I'll try and take the first one and then hand it over to Tal as well. And then I think David will obviously take the second.

我會拿——我會試著拿第一個，然後把它也交給 Tal。然後我認為大衛顯然會選擇第二個。

The -- so first on 50 microgram, I'd remind you of a couple of things. So in this case, this is a third dose of a booster. And so I think we're quite optimistic that a substantially lower dose is necessary because the immune system has already been primed and boosted once. And this is just maturing and updating that immune response to a new variant.

- 所以首先是 50 微克，我要提醒你幾件事。所以在這種情況下，這是加強劑的第三劑。因此，我認為我們非常樂觀地認為需要大幅降低劑量，因為免疫系統已經啟動和增強了一次。這只是對新變體的免疫反應成熟和更新。

And I'll note that we've shared our Phase II data, which does show that we see at 50 micrograms, even in a primary series, really good neutralizing antibodies. And so I think we're quite optimistic that 50 micrograms or lower will suffice as the third dose booster.

我會注意到，我們已經分享了我們的 II 期數據，這確實表明我們在 50 微克，即使在初級系列中也看到了非常好的中和抗體。因此，我認為我們非常樂觀地認為 50 微克或更低的劑量足以作為第三劑加強劑。

This is Tal. The only thing I'd add is that, that has scientific precedence. There's been data, I believe with a malaria vaccine that was published a while ago that showed that if you come in months later, you can come in with a much lower dose and that is sufficient to provide a boost. So in the context of wanting to maximize the ability to provide a benefit from whatever given capacity, I think that strategy makes sense. On top of which, as Stephen alluded to, it could be that even 50 micrograms as a priming series could suffice. Recall that our dose at 100 supersedes what you see with natural infection in terms of neutralizing antibodies to begin with.

這是塔爾。我唯一要補充的是，它具有科學優先權。有數據，我相信不久前發布的一種瘧疾疫苗表明，如果你在幾個月後進來，你可以用低得多的劑量進來，這足以提供加強。因此，在希望最大化從任何給定能力中提供收益的能力的背景下，我認為該策略是有意義的。最重要的是，正如斯蒂芬所暗示的那樣，甚至 50 微克作為啟動系列就足夠了。回想一下，就中和抗體而言，我們在 100 時的劑量取代了您在自然感染中看到的劑量。

Thanks, Tal, and Stephen. On the second question, Matthew, as you know, we have been cautious about talking about supply for the year, and we have raised the number as we have understood better the learning curve of the process, as we've had the lots made and being able to see the demonstrated output. I think it's important to always appreciate this is a new [technology] we have never made and nobody in the world has made at that scale so fast.

謝謝，塔爾和斯蒂芬。關於第二個問題，馬修，如你所知，我們在談論今年的供應方面一直很謹慎，我們提高了這個數字，因為我們更好地理解了這個過程的學習曲線，因為我們已經做了很多，並且能夠看到演示的輸出。我認為重要的是要始終欣賞這是一項我們從未製造過的新技術，而且世界上沒有人能如此迅速地以如此大規模的速度製造出來。

And so it's important for people to understand, we invested and built the manufacturing capacity, the ability to make 1 billion dose. The piece, having worked myself in manufacturing at commercial scale, and of course, you know Juan Andres, who runs manufacturing -- used to run manufacturing for Novartis worldwide, there are so many unknown at this stage that as we learn more, we are upgrading our numbers. As you know, last year, early in the process, we said we feel comfortable we'll get at least 500 million dose of the 1 billion of infrastructure capacity.

因此，人們了解這一點很重要，我們投資並建立了製造能力，製造 10 億劑的能力。這件作品，我自己在商業規模的製造中工作過，當然，你知道負責製造的胡安安德烈斯（Juan Andres）曾經在全球範圍內為諾華（Novartis）公司負責製造，現階段有很多未知數，隨著我們了解更多，我們正在升級我們的數字。如你所知，去年，在這個過程的早期，我們說我們感到很舒服，我們將獲得 10 億基礎設施容量中的至少 5 億劑。

Then we raised it to 600. With what we have seen out of the U.S. supply chain, the -- as you know, Europe is around 3 months behind the U.S. because of when we started building it. We did not have a Norwood-like site in Europe, as you know. We feel good about what's happening in the U.S. The team are doing really a remarkable job. And so we feel comfortable today to up what we call our base case. We feel very comfortable that we will deliver 700 million doses.

然後我們將其提高到 600。根據我們從美國供應鏈中看到的情況，正如你所知，歐洲比美國落後大約 3 個月，因為我們開始建造它的時間。如您所知，我們在歐洲沒有類似諾伍德的網站。我們對美國正在發生的事情感覺很好。團隊做得非常出色。因此，我們今天對我們所說的基本情況感到滿意。我們感到非常放心，我們將提供 7 億劑疫苗。

The team is working extremely hard to get to 1 billion dose. They know that every extra dose we can get out of Moderna supply chain will be used and will help protect people. So you have our full commitment to do everything we can to get as close as we can to 1 billion. But at this stage, what we're saying is we feel very comfortable we can deliver 700 million, base plan. And we are still working through the upside, and I will not bet against the Moderna team to be able to do better. But at this stage, 700 million is the base.

該團隊正在努力工作以達到 10 億劑。他們知道，我們可以從 Moderna 供應鏈中獲得的每一劑額外劑量都將被使用，並將有助於保護人們。因此，您有我們的全部承諾，將盡我們所能盡可能接近 10 億。但在這個階段，我們說的是我們感覺很舒服，我們可以交付 7 億個基本計劃。而且我們仍在努力克服上升空間，我不會打賭 Moderna 團隊能夠做得更好。但現階段，7億是基數。

Your next question comes from the line of Ted Tenthoff with Piper Sandler.

你的下一個問題來自 Ted Tenthoff 和 Piper Sandler 的台詞。

And just incredible progress over the course of the year. And David, thanks for all the clarity on the quarterly update. I'm wondering, with respect to the $200 million that was booked in the fourth quarter, what is the number of vaccines that is ascribed to that? And then if I may, will we be getting any data from the triplet oncology IO program this year?

在這一年中取得了令人難以置信的進步。還有大衛，感謝您對季度更新的所有清晰說明。我想知道，關於第四季度預定的 2 億美元，其中的疫苗數量是多少？如果可以的話，今年我們會從三聯腫瘤 IO 項目中獲得任何數據嗎？

Yes. So the $200 million of revenue was associated with the deliveries that we made to the government in the fourth quarter in the U.S., which was around $17 million.

是的。因此，2 億美元的收入與我們在第四季度向美國政府交付的貨物有關，大約為 1700 萬美元。

And Ted, this is Tal. As it relates to the triplet, I hope so. Data in oncology is a function of when we see responses. And so once we see them and we confirm them, then, of course, that becomes material information that we share. So it's hard to predict, but I would focus on it.

泰德，這是塔爾。因為它與三胞胎有關，我希望如此。腫瘤學中的數據是我們何時看到反應的函數。因此，一旦我們看到它們並確認它們，那當然就成為我們共享的重要信息。所以很難預測，但我會專注於它。

Brilliant. And Tal, wishing you all the best. Thanks for all the hard work.

傑出的。還有塔爾，祝你一切順利。感謝所有的辛勤工作。

Our next question comes from the line of Salveen Richter with Goldman Sachs.

我們的下一個問題來自高盛的 Salveen Richter。

And Tal, I want to second that. Good luck with the path ahead, and you will be missed here.

Tal，我想支持這一點。祝你前路好運，你會在這裡錯過。

So with regard to variance, which of the 3 approaches for COVID on the 4 do you think will be optimal here? And do you have updated thoughts on the correlate of protection or trial design? And then separately, should we expect your pricing strategy for 2022 to be in line with 2021? You did mention options. So I'm just curious how we should think about that.

那麼關於方差，您認為 4 上的 3 種 COVID 方法中的哪一種在這裡是最佳的？你對保護或試驗設計的相關性有更新的想法嗎？另外，我們是否應該期望您 2022 年的定價策略與 2021 年保持一致？你確實提到了選項。所以我只是好奇我們應該如何思考這個問題。

Thank you, Salveen. I'll try and take the first part of that for those questions. So as far as what's optimal, I think we have to run the clinical experiment to know, and that's why you see us taking the 3 approaches. It is entirely possible, maybe even desirable, that 1273 as a third dose is able to boost immunity above a level that would be necessary to provide long-term protection against the new strains.

謝謝你，薩爾文。我將嘗試將第一部分用於這些問題。所以至於什麼是最佳的，我認為我們必須進行臨床實驗才能知道，這就是為什麼你看到我們採用 3 種方法。完全有可能，甚至可能需要，作為第三劑的 1273 能夠將免疫力提高到對新菌株提供長期保護所必需的水平之上。

But if you look forward and say at some point in the future we're going to be perhaps in a regular boosting environment, what would be the ideal vaccine, it seems logical that a vaccine that provides the broadest immunity, so not just against ancestral strains or a boost against the new strains would perhaps be the best mode. And that's where I think the blended approach, so 1273.211 as we announced today might ultimately be the right long term product. But in the near term, we got to run the clinical experiments to get the answer.

但是，如果您展望未來並說在未來的某個時候，我們可能會處於常規的加強環境中，理想的疫苗是什麼，提供最廣泛免疫的疫苗似乎是合乎邏輯的，因此不僅僅是針對祖先菌株或對新菌株的增強可能是最好的模式。這就是我認為混合方法的地方，所以我們今天宣布的 1273.211 最終可能是正確的長期產品。但在短期內，我們必須進行臨床實驗才能得到答案。

Thanks, Stephen. And on the pricing question, Salveen, at this stage, we have not disclosed any information on pricing. The piece that I can share as just color is, as you know, we have a high efficacy vaccine. Governments understand the ability that we have to move fast on variants. And of course, they care deeply about that ability versus other technologies and other companies. And so in due course, as the 2021 year progress, we'll be sharing more color on the pricing strategy for 2022 when for both of the prime series as well as the variant. It might be the same, it might not be the same. So we'll discuss that in due course. Thank you.

謝謝，斯蒂芬。關於定價問題，Salveen，現階段，我們還沒有透露任何定價信息。我可以分享的只是顏色，如你所知，我們有一種高效疫苗。政府了解我們必須在變體上快速行動的能力。當然，與其他技術和其他公司相比，他們非常關心這種能力。因此，在適當的時候，隨著 2021 年的進展，我們將在 2022 年的定價策略上分享更多關於主要係列和變體的定價策略。可能一樣，也可能不一樣。所以我們會在適當的時候討論這個問題。謝謝你。

And Salveen, this is Tal. Thanks for your kind note. And I wanted to answer your question about the correlate. I think that work continues. It's being primary led by NIH who have access to all our samples as well as the other BARDA funded trials.

還有 Salveen，這是 Tal。謝謝你的好意。我想回答你關於相關性的問題。我認為這項工作仍在繼續。它主要由 NIH 領導，他們可以訪問我們所有的樣本以及其他 BARDA 資助的試驗。

The current assumption is that we should be able to move even without a correlate, and that is consistent with the recent FDA guidance on the development of a variant vaccine. I think if there does emerge a correlative protection, it will make everybody's life easier, especially those coming up in our footsteps in terms of licensing new vaccines. But I think also, for us, the ability to peg the dose level will be substantially made easier with that. So we continue to work towards that goal. We'll see in the coming months whether when one emerges.

目前的假設是，即使沒有相關性，我們也應該能夠行動，這與 FDA 最近關於開髮變異疫苗的指導是一致的。我認為，如果確實出現了相關保護，它將使每個人的生活更輕鬆，尤其是那些在許可新疫苗方面步我們後塵的人。但我也認為，對我們來說，確定劑量水平的能力將變得更加容易。所以我們繼續朝著這個目標努力。我們將在接下來的幾個月中看到是否會出現。

Your next question comes from the line of Michael Yee with Jefferies.

您的下一個問題來自 Michael Yee 與 Jefferies 的對話。

Again, congrats on all the progress. Two questions. One is a variant timing, manufacturing question and one is a competitor question. I guess based on what you described today, can you just kind of walk through the timing of how to develop and what would be needed to get a variant vaccine approved and when you would be able to flip the switch to start making that? That's just question 1 for variant.

再次祝賀所有進展。兩個問題。一個是變體時間、製造問題，一個是競爭對手問題。我想根據您今天的描述，您能否簡單介紹一下如何開發的時間，以及獲得批准變異疫苗所需的條件，以及何時能夠打開開關開始製造？這只是變體的問題1。

And then related to that, maybe for Tal, before we let you go, maybe you could comment about how you think about variant vaccines for mRNA versus adeno, particularly with multiple streams in there? How do you think about comparing and contrasting?

然後與此相關，也許對於 Tal，在我們讓你離開之前，也許你可以評論一下你如何看待 mRNA 與腺苷的變體疫苗，特別是在那裡有多個流？您如何看待比較和對比？

So maybe I'll take the first part of it and then hand over to Tal for the second. I think the -- so first, on how quickly we think this goes. We've already, I think, demonstrated that we can pretty quickly produce a new batch. And if you look back to when we announced that we started manufacturing, it might be even faster than last year.

所以也許我會拿它的第一部分，然後把第二部分交給 Tal。我認為 - 首先，關於我們認為這進展得有多快。我認為，我們已經證明我們可以很快生產出一批新產品。如果您回顧我們宣布開始生產的時間，可能會比去年更快。

We do think the clinical program for testing this is pretty straightforward based on the recent FDA guidance and other public comments. It's likely to be in the hundreds of people and immunogenicity and safety as important endpoints there. But ultimately, that will be subject to discussions with the FDA. And so we think we could get to clinical data here relatively quickly. Then we'll be able to demonstrate the potential for a booster vaccine to close a potential gap in immunity.

根據最近的 FDA 指南和其他公眾評論，我們確實認為用於測試這一點的臨床計劃非常簡單。它可能存在於數百人中，並且免疫原性和安全性是那裡的重要終點。但最終，這將取決於與 FDA 的討論。所以我們認為我們可以相對快速地獲得臨床數據。然後，我們將能夠證明加強疫苗有可能縮小免疫方面的潛在差距。

As far as production, that will depend a lot on the demand picture and possibly that data. But as Stéphane noted, our manufacturing systems, really, we believe we could almost copy and paste the new information into those manufacturing systems and proceed very quickly to be updating our vaccine or produce a booster.

就生產而言，這在很大程度上取決於需求情況以及可能的數據。但正如 Stéphane 指出的那樣，我們的製造系統，真的，我們相信我們幾乎可以將新信息複製並粘貼到這些製造系統中，並非常迅速地更新我們的疫苗或生產助推器。

Tal, do you want to take the second part of that?

塔爾，你想看第二部分嗎？

Yes. That's a softball. Look, the mRNA, the beauty of the mRNA technology is the fact that the immune system doesn't recognize the LMPs per se. It only recognizes the protein that we teach the body to make. And so I believe that our vaccine platform is optimally suited to boost, irrespective of what primary series somebody got, whether it was a protein mRNA or, frankly, an adenovector.

是的。那是壘球。看，mRNA，mRNA技術的美妙之處在於免疫系統本身不能識別LMP。它只識別我們教身體製造的蛋白質。因此，我相信我們的疫苗平台最適合加強免疫，無論人們得到的是什麼主要係列，無論是蛋白質 mRNA 還是坦率地說是腺載體。

I think the challenge with the adenovector is for both the initial boost and certainly any work with variants down the road is going to be that the adenovectors generate significant immunity against the other components of the adenovirus and thus, have the risk of limiting the ability to translate the transgene. And therefore, if you look at the boosting delta, that is how much additional antibody levels do you get from a boost, with adenovectors, you can get a boost, but the magnitude of that boost is invariably less than the magnitude of the boost you get with an mRNA platform. And that is true just in the first boost. I suspect that if you needed to come with a third dose or a fourth dose or variant-specific vaccines, it would be challenging to get the requisite amount of specific immune recognition towards the new transgene.

我認為腺載體的挑戰在於最初的增強，當然任何與變體有關的工作都將是腺載體對腺病毒的其他成分產生顯著的免疫力，因此有限制能力的風險翻譯轉基因。因此，如果您查看增強增量，您可以從增強中獲得多少額外的抗體水平，使用腺載體，您可以獲得增強，但增強的幅度總是小於您的增強幅度獲得一個 mRNA 平台。僅在第一次提升中就是如此。我懷疑，如果您需要接種第三劑或第四劑或變異特異性疫苗，那麼獲得對新轉基因的必要數量的特異性免疫識別將是一項挑戰。

Your next question comes from the line of Gena Wang with Barclays.

您的下一個問題來自巴克萊銀行的 Gena Wang。

Tal, good luck with your next journey. It's a big shoe to fill, and you will certainly be missed here. I have 2 questions regarding the variance and also next-generation COVID vaccine 1283. So for 1283, is it shorter sequence that make freezer storage feasible? And also with the sequence outside of RBM sequence -- RBM multi sequence?

塔爾，祝你下次旅行好運。這是一隻大鞋，你肯定會在這裡錯過。關於變異以及下一代 COVID 疫苗 1283，我有 2 個問題。那麼對於 1283，是否更短的序列可以使冷凍儲存可行？還有RBM序列之外的序列——RBM多序列？

And then the second part of the question is the COVE II variant for the NIH study. I wondering if you can give a little bit more color regarding type of subjects you will enroll, whether it's a vaccine-naive or experienced subjects and also the booster timing.

然後問題的第二部分是 NIH 研究的 COVE II 變體。我想知道您是否可以就您將註冊的受試者類型提供更多顏色，無論是初次接種疫苗還是經驗豐富的受試者，以及助推器時間。

Thank you for the questions, Gena. I'll take the first part of that and then hand it over to Tal to answer the NIH component.

謝謝你的問題，吉娜。我將採取其中的第一部分，然後將其交給 Tal 來回答 NIH 組件。

So in terms of the mRNA-1283, it is correct. It is -- the fact that it is a shorter mRNA does help with the long term stability and does facilitate, we think, moving that into a refrigerated vaccine. It's not the only feature. As you'll know, we've had advantages on our mRNA platform based on our long history of working in it, for instance, that we're functioning right now already, as has been noted, in a normal freezer for up to 6 months and actually already doing 30 days with mRNA-1273 in a refrigerator post stalling. And so it's a benefit that we're already well on that path, even with just 1273.

所以就 mRNA-1283 而言，它是正確的。事實上，它是一個較短的 mRNA 確實有助於長期穩定性，並且我們認為確實有助於將其轉移到冷藏疫苗中。這不是唯一的功能。如您所知，基於我們在 mRNA 平台上的長期工作歷史，我們在我們的 mRNA 平台上具有優勢，例如，我們現在已經在正常工作，如前所述，在普通冰箱中最多可存放 6幾個月，實際上已經用 mRNA-1273 在冰箱中放置了 30 天。因此，即使只有 1273，我們已經在這條道路上做得很好，這是一個好處。

I think the second part of your question was, is it just the RBM, and 1283 covers both the RBD and the end terminal domain. And as has been widely reported, those are particularly important for neutralizing activity in the immune system against SARS-CoV-2 virus.

我認為您問題的第二部分是，它只是 RBM，而 1283 涵蓋了 RBD 和終端域。正如廣泛報導的那樣，這些對於中和免疫系統中針對 SARS-CoV-2 病毒的活性特別重要。

Thanks, Stephen. Gena, thank you for your kind comments. The NIH, I'll defer to my colleagues there to describe their trial in the coming weeks once they launch it. But in essence, the answer is both. They will have arms there that will be testing the new variant vaccine as a boost in those who have been previously immunized on their Phase I trial. And then there will be a component that will test the new vaccine in a primary series.

謝謝，斯蒂芬。 Gena，感謝您的友好評論。 NIH，一旦他們啟動它，我將在未來幾週內向我的同事介紹他們的試驗。但從本質上講，答案是兩者兼而有之。他們將在那裡擁有武器，將測試新的變種疫苗，作為對先前在 I 期試驗中接種過疫苗的人的推動。然後會有一個組件在初級系列中測試新疫苗。

Your next question comes from the line of Cory Kasimov with JPMorgan.

您的下一個問題來自摩根大通的 Cory Kasimov。

And all the best to Tal, although it's good to know we'll have you for a couple more quarters. So 2 questions for me as well. Look, I realize there's not much you can say on pricing beyond 2021. But as we think about your booster strategies that could be less frequent at lower doses as well as the greater supply of vaccines we should have on the market, balanced against the potential waning of the pandemic, are there scenarios where the price per dose could be either materially higher or lower than what we're looking at in 2021?

祝塔爾萬事如意，儘管很高興知道我們還會讓你多住幾個季度。所以我也有兩個問題。聽著，我意識到你對 2021 年以後的定價沒有什麼好說的。但是當我們考慮到你的加強策略可能會在較低劑量下不那麼頻繁，以及我們應該在市場上擁有更多的疫苗供應，與潛力相平衡隨著大流行的消退，是否存在每劑價格可能大大高於或低於我們在 2021 年看到的價格的情況？

And then my second question is from a modeling standpoint. Should we be assuming anything in the model above and beyond what was talked about today that could be owed to the U.S. government for the initial co-development of your COVID vaccine? Or is that what David was referring to with the royalties that are included as part of your cost of sales? And if so, should we just be assuming a generally stable rate going forward? Are those changed at all?

然後我的第二個問題是從建模的角度來看。我們是否應該假設模型中的任何內容超出今天所討論的內容，這些內容可能歸功於美國政府最初共同開發的 COVID 疫苗？或者這就是大衛所說的作為銷售成本一部分的特許權使用費？如果是這樣，我們是否應該假設未來的利率總體穩定？那些都改變了嗎？

So there's a lot to unpack here. Let me start maybe on pricing. So it's quite interesting because, as you know, this is public information, there are some vaccines that have been made available to governments at $3 per dose. And as you know, we walked you through our pricing strategy back, I think, in August, on the Q2 call. The Moderna vaccine is priced much higher.

所以這裡有很多東西要解壓。讓我從定價開始吧。所以這很有趣，因為正如你所知，這是公開信息，有些疫苗已經以每劑 3 美元的價格提供給政府。如您所知，我們在 8 月的第二季度電話會議上向您介紹了我們的定價策略。 Moderna 疫苗的價格要高得多。

And I think it comes down to a few things. And the most important one is efficacy. Governments care about saving lives. Governments care about getting the economies back on their feet. And so what we're hearing from governments, literally almost on a daily basis as we engage with our existing government contacts versus new ones that are calling us, is -- there starts to be very clear differentiations between the different products that are either available already or that are getting very close to authorization.

我認為這歸結為幾件事。而最重要的是功效。政府關心拯救生命。政府關心讓經濟重新站起來。因此，我們從政府那裡聽到的消息，幾乎每天都在與我們現有的政府聯繫人打交道，而不是給我們打電話的新聯繫人，開始出現非常明顯的區別，即可用的不同產品之間的區別已經或者已經非常接近授權了。

And I wish, if I had a crystal ball last year, that we would have built more manufacturing capacity for '21. But I did not anticipate and I don't think anybody did that there will be such difference of efficacy between vaccine, that the mRNA vaccine will be such high performance. As you know, some countries decided to invest first to procure vaccine in adeno or protein technology because they were better understood. And as we know what happened in 2020 in terms of the clinical data, that has played a big role.

我希望，如果我去年有一個水晶球，我們會為 21 年建立更多的製造能力。但我沒有預料到，而且我認為沒有人會在疫苗之間會有如此大的功效差異，以至於 mRNA 疫苗會有如此高的性能。如您所知，一些國家決定首先投資採購腺病毒或蛋白質技術疫苗，因為它們被更好地了解。我們知道 2020 年在臨床數據方面發生了什麼，這發揮了重要作用。

So it's quite interesting that -- also seeing how people are reacting in the countries. If you follow the media, for example, in Europe, where several vaccines have been authorized. As you know, in U.S., we have as of today, I'm hopeful this will change soon with VRBPAC meeting tomorrow, but only to mRNA vaccine authorized in the U.S.

所以這很有趣——還可以看到人們在這些國家/地區的反應。如果您關注媒體，例如在歐洲，有幾種疫苗已獲得授權。如您所知，在美國，從今天開始，我希望這將在明天的 VRBPAC 會議上很快改變，但僅限於在美國授權的 mRNA 疫苗。

But if you look at what's happening in some countries in Europe, also what's happening in different countries around the world, I think governments, because of essence, advisers and clinical advisers and because of really the aim to reduce the pressure on the health care system, in the hospitals.

但是如果你看看歐洲一些國家正在發生的事情，以及世界上不同國家正在發生的事情，我認為政府，因為本質、顧問和臨床顧問，並且因為真正的目的是減少對醫療保健系統的壓力，在醫院。

Also what is quite fascinating, and I'm sure you're all observing it, is that, at least the first time in my career, being 20 years in this business, that in the media every day, you hear about vaccines on TV, in the newspaper, online. And you have the product efficacy that are all over the news every day. This has never happened to my knowledge for any of our products.

還有一點非常令人著迷，我相信你們都在觀察它，至少在我的職業生涯中第一次，在這個行業工作了 20 年，每天在媒體上，你會在電視上聽到關於疫苗的消息，在報紙上，在網上。而且您擁有每天都在新聞中的產品功效。據我所知，我們的任何產品都從未發生過這種情況。

And so you have this very interesting phenomenon that's happening too, that you have the clinicians, the nurses, the pharmacists, but the consumers too, that are believing that those products are not all the same. And this, I think will be a very important differentiation as we move into '22, as we move more to a traditional commercial market, where it's not governments buying directly, but the traditional kind of retail channel. And the impact, I think, of the consumers' desire to ask for a product when he or she walks into a pharmacy or their GP's office will be quite significantly different from what we are used to with other products.

所以你有一個非常有趣的現像也在發生，你有臨床醫生、護士、藥劑師，還有消費者，他們相信這些產品並不完全相同。我認為，隨著我們進入 22 世紀，這將是一個非常重要的差異化，因為我們更多地轉向傳統的商業市場，在那裡不是政府直接購買，而是傳統的零售渠道。而且，我認為，當消費者走進藥房或他們的全科醫生辦公室時，他們想要詢問產品的願望的影響將與我們對其他產品的習慣有很大不同。

Okay. Maybe then I'd comment on the question about cost of sales. So Cory, what I did try to say early on was that we don't have precision in all cases. In the case of cost of sales, I would say there are puts and takes that we're monitoring, but we gave you the 20%, because we feel confident that, that's the right range, right zone that we're in. And yes, as we move through time, there's going to be more information as we ramp up our factory capabilities and answer some of the other questions. But I think you're good for now with that modeling assumption.

好的。也許那時我會評論有關銷售成本的問題。所以科里，我早些時候確實試圖說的是，我們並不是在所有情況下都具有精確性。在銷售成本的情況下，我會說我們正在監控看跌期權，但我們給了你 20%，因為我們有信心，這是我們所處的正確範圍和正確區域。而且是的，隨著時間的推移，隨著我們提高工廠能力並回答其他一些問題，將會有更多信息。但我認為你現在對這個建模假設很好。

Your next question comes from the line of Geoff Meacham with Bank of America.

您的下一個問題來自美國銀行的 Geoff Meacham。

Also I wanted to offer up best wishes to Tal. A question on manufacturing investments, I guess, for Stéphane. So I guess I'll focus on variance with the booster. And clearly, you guys have to fund many assets progressing in the pipeline. But how flexible are your manufacturing investments? I guess the question is, as the cases globally continue to decline, is there a way to scale back some of that capacity should lower volumes become the norm?

我也想向塔爾致以最美好的祝愿。我猜想是給 Stéphane 的一個關於製造業投資的問題。所以我想我會專注於與助推器的差異。顯然，你們必須為許多正在籌備中的資產提供資金。但是您的製造投資有多靈活？我想問題是，隨著全球病例持續下降，如果減少量成為常態，是否有辦法縮減部分產能？

Those are great questions. So in terms of the flexibility, as I described in my remarks, the only raw material that is different from let's say mRNA-1273 to mRNA-1273.351 is only the plasmid. The enzymes are the same, the lipid is the same, with the same equipment in the same rooms with the same people. So the flexibility of this technology is really incredible for people that have worked with recombinant, like I used to do at Lilly. And as you know, I trained as a biochemical engineer, doing neutrophil and E. coli production in bioreactors. It is literally, you come a week after we use disposable reactors, you get new consumable plastic bags and so on as your reactor. And here you go again, you just need to change -- take a different plasmid. Because we use disposable reactors and not stainless steel reactors you don't have to spend a lot of time doing cleaning, validation because we basically dispose of things.

這些都是很好的問題。因此，就靈活性而言，正如我在評論中所描述的，唯一不同於假設 mRNA-1273 和 mRNA-1273.351 的原材料只是質粒。酶是一樣的，脂質是一樣的，同樣的設備，同樣的人，同樣的房間。因此，這項技術的靈活性對於那些使用重組技術的人來說確實令人難以置信，就像我以前在禮來公司所做的那樣。如你所知，我接受過生化工程師培訓，在生物反應器中生產中性粒細胞和大腸桿菌。從字面上看，您在我們使用一次性反應器一周後來，您會得到新的消耗性塑料袋等作為您的反應器。你又來了，你只需要改變——換一個不同的質粒。因為我們使用一次性反應器而不是不銹鋼反應器，所以您不必花費大量時間進行清潔和驗證，因為我們基本上是處理東西。

And so the flexibility is quite incredible. You just need a new plasmid. And so because -- so it's not a very expensive part of the cost of the total cost of the finished product that is filled in a vial, because you have to make the mRNA, you have to formulate it and you have to fill it in a vial, our doing a lot of plasmid at risk for variant is a great optionality for the company with very, very [seldom] payment.

所以靈活性是相當令人難以置信的。你只需要一個新的質粒。所以因為——所以它不是裝在小瓶中的成品總成本中非常昂貴的部分，因為你必須製造 mRNA，你必須配製它，你必須把它填滿一個小瓶，我們做很多有風險的質粒變體對於公司來說是一個很好的選擇，非常非常[很少]付款。

So that's a piece that I think makes this technology very unique on the ability to scale and be able to be flexible to respond to different demand. Is there a world where we potentially might end up with a different combination of mutant boost on the road in different continents? Maybe. I don't know, again, it will be market-driven. But if it is what the market requires, we can accommodate that in a way that is totally atypical to what the industry could do and at the speed, which is, I think will surprise many. Because again, we make these other products in the same reactors.

因此，我認為這一點使這項技術在擴展能力和靈活響應不同需求方面非常獨特。有沒有這樣一個世界，我們最終可能會在不同大陸的道路上獲得不同的突變增強組合？也許。我不知道，這將是市場驅動的。但是，如果這是市場需要的，我們可以以一種與行業完全不同的方式和速度來適應它，我認為這會讓很多人感到驚訝。因為同樣，我們在同一個反應器中生產這些其他產品。

In terms of taking down the manufacturing capacity if we don't need, let's say, in '23 or '24, the same amount of volume because of a mass of boosting, as we say, it's actually interesting because, as you know, we have now good plants where we have quite a lot of capacity. But also, we have some capacity at Lonza, in New Hampshire and also capacity in Switzerland, where they have there several lines of manufacturing. So we have actually quite a lot of flexibility to take capacity down at Lonza, either in the U.S. and/or in Europe at different time points. So that's one point.

在我們不需要的情況下降低製造能力，比如說，在 23 或 24 年，由於大量的提升，相同數量的產量，正如我們所說，這實際上很有趣，因為如你所知，我們現在有很好的工廠，我們有很大的產能。而且，我們在新罕布什爾州的龍沙有一些產能，在瑞士也有產能，他們在那裡有幾條生產線。因此，我們實際上有很大的靈活性來降低 Lonza 的產能，無論是在美國和/或歐洲的不同時間點。所以這是一點。

The other piece we should not forget is the pipeline. And I will just make 2 comments, which I think are very important to understand why actually us building manufacturing to that scale is going to be so enabling to Moderna to keep growing and growing and growing.

我們不應該忘記的另一部分是管道。我將僅發表 2 條評論，我認為這對於理解為什麼我們實際上建立如此規模的製造業將如此有助於 Moderna 保持增長、增長和增長非常重要。

First is the other vaccines. CMV is ready to move into Phase III, as we said this year. We will give you updates on the flu program, but I will remind everybody that there is an approvable endpoint with the regulator for seasonal flu vaccines. And so we anticipate that the development of the flu program will be pretty quick.

首先是其他疫苗。正如我們今年所說，CMV 已準備好進入第三階段。我們將為您提供有關流感計劃的最新信息，但我會提醒大家，監管機構有一個可批准的季節性流感疫苗終點。因此，我們預計流感項目的開發將非常迅速。

And as we discussed on previous calls, one of our kind of optimal target product profile for down the road will be a product that is both seasonal flu, with the current strain of flu, but also a boost for COVID-19 with the relevant strain at that time in the same dose. So we anticipate we should have high efficacy for flu as much as mRNA virus. It's a pretty straightforward virus like the SARS-CoV-2 virus.

正如我們在之前的電話會議中所討論的那樣，我們未來的最佳目標產品配置之一將是一種產品，它既是季節性流感，具有當前的流感毒株，又是具有相關毒株的 COVID-19 的助推器當時以相同的劑量。因此，我們預計我們對流感的療效應該與 mRNA 病毒一樣高。這是一種非常簡單的病毒，例如 SARS-CoV-2 病毒。

And so that is where we are going. We have more vaccines coming to the market. And then there's also our therapeutic pipeline. And the piece, I think, that is actually quite good for us that we started with vaccine, the scale-up, is I go back to mass, which is if you think about some of our products, as you know 1273 requires 100-microgram per human per dose. But if you look at the chikungunya antibody program, that use the IV-formulated mRNA that we use also in the rare disease program, for example, what we showed is very good data at 0.1 milligram per kilo. So in a 70-kilo adult, it is 7 milligram compared to 100 micrograms.

這就是我們要去的地方。我們有更多的疫苗進入市場。然後還有我們的治療管道。我認為，這對我們來說實際上非常好，我們從疫苗開始，擴大規模，是我回到大規模，如果你想想我們的一些產品，你知道 1273 需要 100-每人每劑量微克。但是如果你看一下基孔肯雅抗體項目，它使用了我們也在罕見病項目中使用的 IV 配製的 mRNA，例如，我們展示了非常好的數據，每公斤 0.1 毫克。所以在一個 70 公斤的成年人中，它是 7 毫克，而 100 微克。

So as we move the therapeutic pipeline further into development, but especially to commercial, we're going to need much more mass of mRNA. And so I actually -- I'm spending a lot of time thinking, one, how do we keep adding capacity to manage the entire pipeline as it's progressing. We have the flexibility with Lonza, that's why we did it this way with Juan, so we are ready to take it -- take chunks down if we need to. But if I was a betting man, I would bet with you that we're going to be more adding than taking capacity down because of the probability of technical success. As I've said all along, I believe we will launch the CMV vaccine, given the data we have, the medical need and the biology we're able to do with both the pentamer and GB. And so I'm more spending time wanting to think about how do we do more.

因此，隨著我們將治療管道進一步推進開發，尤其是商業化，我們將需要更多質量的 mRNA。所以我實際上 - 我花了很多時間思考，一個，我們如何在整個管道的進展過程中不斷增加管理整個管道的能力。我們對 Lonza 有靈活性，這就是我們對 Juan 這樣做的原因，所以我們準備好接受它——如果我們需要的話，把它拿下來。但如果我是一個賭徒，我會和你打賭，由於技術成功的可能性，我們將增加而不是減少容量。正如我一直所說的，我相信我們將推出 CMV 疫苗，考慮到我們擁有的數據、醫療需求以及我們能夠對五聚體和 GB 進行的生物學研究。所以我更多地花時間思考我們如何做得更多。

Your next question comes from the line of Hartaj Singh with Oppenheimer & Co.

您的下一個問題來自奧本海默公司的 Hartaj Singh。

Great. And Tal, I wish you the very best in your future endeavors. The question I have is, we're hearing more and more about some constraints in the raw materials that go into making vaccines, plasmids, things as simple as pipettes, et cetera. Can you just give us some color and visibility on where Moderna is with its partners, Lonza and others, in this regard to 2021 and 2022 supply? And then could that be a rate-limiting step as you think about other modalities?

偉大的。塔爾，我祝你在未來的努力中一切順利。我的問題是，我們越來越多地聽到有關製造疫苗、質粒以及移液管等簡單物品的原材料的一些限制。在 2021 年和 2022 年供應方面，您能否給我們一些關於 Moderna 與其合作夥伴 Lonza 和其他公司在哪裡的顏色和可見性？然後，當您考慮其他方式時，這可能是一個限速步驟嗎？

Thanks. So as we've said all along, which is why we gave a range and not one number for expected supply in the year, I think one number is a very dangerous strategy. As we said, those type of consumables are, of course, important. We are in a regulated business, and we cannot start to make a product until we have all the components, all the raw material, the entire train team and so on and so forth. So we have a lot of -- like in an airplane, you have to check a lot of things before you can start the engine. Well, in GMP manufacturing, you have to do the same to ensure the quality and the safety of the product.

謝謝。因此，正如我們一直所說的，這就是為什麼我們給出了一個範圍而不是一個數字來表示今年的預期供應量，我認為一個數字是一種非常危險的策略。正如我們所說，這些類型的消耗品當然很重要。我們是一家受監管的企業，在我們擁有所有組件、所有原材料、整個火車團隊等等之前，我們無法開始製造產品。所以我們有很多——比如在飛機上，你必須在啟動引擎之前檢查很多東西。那麼，在GMP製造中，您必須這樣做以確保產品的質量和安全性。

And so, well, I think the team has done a very good job last year. And as you recall, we started racing against this virus in very early January. And it's in the late January time frame that we started to say, geez, this could turn into a pandemic. And we started to think bigger. And so, one, the team and I spent quite a lot of time as we were starting to think about, okay, how do we go -- if we had to make 1 billion dose in '21, how would we do that? I used to run the supply chain at Lilly globally. And we went right away to start to talk to our suppliers.

所以，嗯，我認為球隊去年做得很好。你還記得，我們在一月初就開始與這種病毒賽跑。正是在 1 月下旬的時間框架內，我們開始說，天哪，這可能會演變成一場大流行。我們開始思考更大的問題。所以，一，團隊和我花了很多時間開始思考，好吧，我們該怎麼做——如果我們必須在 21 年生產 10 億劑，我們會怎麼做？我曾經在禮來（Lilly）負責全球供應鏈。我們立即開始與我們的供應商交談。

And one other thing we had to do, and if you recall, we did an important capital raise in May of last year, which was very important for getting us to where we are today, in some suppliers. Because the increase of mass of product we're ordering from them was so gigantic, a thousand times more, even 2,000 times more than the year before.

還有一件我們必須做的事情，如果你還記得的話，我們在去年 5 月進行了一次重要的融資，這對於讓我們在一些供應商中取得今天的成就非常重要。因為我們從他們那裡訂購的產品質量增長如此之大，比前一年多了一千倍，甚至是兩千倍。

As you can imagine, many of them looked at us a bit funny and were very worried. They were worried that if the drug would fail, they might be in trouble, because they will have to get this type of increase of capacity to sometime, buy new equipment, hire more people, buy their own raw materials to make our raw materials for our product, if that makes sense.

可以想像，他們中的許多人看著我們有點好笑，非常擔心。他們擔心如果藥物失敗，他們可能會遇到麻煩，因為他們將不得不在某個時候獲得這種產能增加，購買新設備，僱用更多人，購買他們自己的原材料來製造我們的原材料。我們的產品，如果這有意義的話。

And so sometimes what we have to do with the team is actually to pay upfront the entire purchase of product so that they will go and take that cash and start to invest to prepare for scale up. So we took a lot of business risk last year that we thought were necessary to ensure we could deliver this year on the output from the manufacturing supply chain.

所以有時我們與團隊要做的實際上是預先支付整個產品的購買費用，這樣他們就會去拿現金並開始投資以準備擴大規模。因此，我們去年承擔了很多業務風險，我們認為這是確保我們今年能夠交付製造供應鏈的產出所必需的。

So I think we're in a good place. Do we have from time to time, one component that give us a sleepless night because it's very tight? It's happening because the ramp-up the industry is doing is unprecedented. But so far, so good, and we are extremely on top of it, including as we do things like increasing capacity that we announced last night to right away, not only buy new machine, but right away, place new orders for raw materials and make sure we keep increasing our safety stock so that we run this more and more as a regular business where you have safety stock on site. So if your supplier has a bump in the road, a pump breaking or something else, that we are able to manage that variability, which is normally manufacturing without impacting our ability to maximize our own output.

所以我認為我們處在一個好地方。我們是否時不時有一個因素讓我們因為非常緊張而徹夜難眠？之所以發生這種情況，是因為該行業的發展速度是前所未有的。但到目前為止，一切都很好，我們非常了解它，包括在我們做昨晚宣布的增加產能之類的事情時，不僅要立即購買新機器，而且要立即下新的原材料訂單和確保我們不斷增加安全庫存，以便我們越來越多地將其作為常規業務運營，您在現場有安全庫存。因此，如果您的供應商遇到問題、泵故障或其他問題，我們能夠管理這種可變性，這通常是在製造過程中，而不會影響我們最大化自身產量的能力。

Our next question comes from the line of Simon Baker with Redburn.

我們的下一個問題來自 Redburn 的 Simon Baker。

Two, if I may, please. Firstly, just going back to cost of goods sold. You've helpfully given us the 20% figure for 2021. But presumably, there will be some degree of variation through quarters. So would it be fair to assume that you will be exiting the year at a figure lower than 20%? And I just wonder if you could give us some color on if that would be meaningfully below 20%.

二，如果可以的話，請。首先，回到所售商品的成本。您為我們提供了 2021 年 20% 的數字，這對我們很有幫助。但據推測，每個季度都會有一定程度的變化。那麼假設您將以低於 20% 的數字退出這一年是否公平？我只是想知道你是否可以給我們一些顏色，如果它會有意義地低於 20%。

And then moving away from COVID to CMV. You've said that the peak sales potential for the CMV vaccine could be around $2 billion to $5 billion per year. It would seem that HPV is a pretty good road map for the potential in that space and set against that, $2 billion to $5 billion looks quite conservative. So I was just wondering if I'm missing something in that analogy or whether that $2 billion to $5 billion is out of an abundance of caution?

然後從 COVID 轉移到 CMV。您曾說過 CMV 疫苗的最高銷售潛力可能在每年 20 億至 50 億美元左右。 HPV 似乎是該領域潛力的一個很好的路線圖，與此相反，20 億至 50 億美元看起來相當保守。所以我只是想知道我是否在這個類比中遺漏了什麼，或者這 20 億到 50 億美元是否出於謹慎考慮？

Yes. Maybe I'll take the first one. On the cost of goods, percent of sales, our advice right now is to assume that's pretty stable through the year, including as we exit the year. So I would recommend you model it consistently. There will be some ups and downs. And the ups and downs are more related to the mix of business and the price levels of the product that necessarily changes in the cost of the produced product. And hence, given that, we get out towards the year-end, we don't have complete visibility on precisely what the book of business and mix will look like of sales, hence, some uncertainty around the precise percentage number. But again, I would advise just treating it as a constant for now. And then as we get better information, we'll give that to you as we move through the year.

是的。也許我會拿第一個。關於商品成本，佔銷售額的百分比，我們現在的建議是假設這一年相當穩定，包括我們退出這一年。因此，我建議您始終如一地對其進行建模。會有一些起起落落。而漲跌更多地與業務組合和產品價格水平有關，而產品價格水平必然會改變生產產品的成本。因此，鑑於我們將在年底前退出，我們無法完全了解業務賬簿和銷售組合的具體情況，因此，準確的百分比數字存在一些不確定性。但同樣，我建議暫時將其視為常數。然後，隨著我們獲得更好的信息，我們將在這一年中將其提供給您。

Thank you, David. So let me take the CMV question. So a few bit of colors on the $2 billion to $5 billion annual peak sale estimate that we talked about now a while ago. We talked about that as a company that never had run a Phase III at the time, that had never launched a product or get a product approved at the time, that had 0 commercial employee at the time. So we did the analysis with an outside commercial consulting company and with our strategy team and the team here that many of us have commercial experience.

謝謝你，大衛。所以讓我來回答 CMV 的問題。因此，對我們剛才談到的 20 億至 50 億美元的年度銷售峰值估計有一些色彩。作為一家當時從未運行過第三階段、從未推出產品或獲得產品批准、當時只有 0 個商業員工的公司，我們談到了這一點。因此，我們與一家外部商業諮詢公司、我們的戰略團隊以及我們中的許多人都有商業經驗的團隊一起進行了分析。

So we tend to be cautious, because as a new company we want to make sure that we build credibility and credibility in life has to be earned. And so I will just make the analogy to manufacturing in the sense, we built 1 billion of capacity, and we are very upfront to the financial community about it last year when we did so. But we said, look, given the unknown on raw material supply, given the unknown on yield, we feel comfortable we should get at least 500 million dose out. And then as we learned more, we moved it to 600. And as we learned more, we moved it yesterday to 700 million.

所以我們傾向於謹慎，因為作為一家新公司，我們希望確保我們在生活中建立信譽和信譽。因此，我將在某種意義上與製造業進行類比，我們建立了 10 億個產能，去年我們這樣做時，我們對金融界非常坦率。但是我們說，看，鑑於原材料供應的未知數，鑑於產量的未知數，我們感到放心，我們應該得到至少 5 億劑。然後隨著我們了解更多，我們將其移至 600。隨著我們了解更多，我們昨天將其移至 7 億。

So do I believe it is possible as we're going to sell more than 5 billion of CMV? Yes, I believe it's possible because it's an incredible unmet medical need. As the world develops, I think the piece one has to be careful about peak sales is peak sales when peak sales slightly up (inaudible) peak sales 25 years after launch because those vaccines are like annuity-like products. There's, of course, inflation. There's, of course, developing countries that are becoming richer and richer. So is there upside to the number? I believe there's upside to the number. But that's our number right now as a company.

那麼我相信我們將銷售超過 50 億的 CMV 是可能的嗎？是的，我相信這是可能的，因為這是一個令人難以置信的未滿足的醫療需求。隨著世界的發展，我認為人們必須小心銷售高峰是在推出 25 年後銷售高峰略微上升（聽不清）的銷售高峰，因為這些疫苗就像類似年金的產品。當然，還有通貨膨脹。當然，也有越來越富裕的發展中國家。那麼這個數字有上升空間嗎？我相信這個數字有好處。但這是我們現在作為一家公司的數字。

Our next question comes from the line of Mani Foroohar with SVB Leerink.

我們的下一個問題來自 SVB Leerink 的 Mani Foroohar。

Tal, looking forward to chatting with you later on today in our fireside chat, and excited to hear at some point what your next adventure is going to be.

Tal，期待今天晚些時候在我們的爐邊聊天中與您聊天，並很高興在某個時候聽到您的下一次冒險將是什麼。

A quick and sort of boring financial question. As we -- as you guys are pretty clearly going to transition to profitability, cash flow positivity on a -- at least in the near term, very durable basis, when would you consider changing your current treatment of your NOL allowances? How would that -- how would you communicate that? How would that flow through how you communicate your financials from a modeling perspective?

一個快速而無聊的財務問題。由於我們——你們很明顯將過渡到盈利能力，現金流積極——至少在短期內，非常持久的基礎上，你什麼時候會考慮改變你目前對 NOL 津貼的處理方式？那將如何——你將如何溝通？從建模的角度來看，這將如何貫穿您如何傳達您的財務狀況？

And then secondarily, and maybe scientifically, more interestingly, how do you interpret the data suggesting that at least for the adenoviral approach from J&J, but also from your own data and the other mRNA vaccine, that titers appear to improve over time and cellular immunity improves over time and the gap in efficacy against the so-called South African variance and the ancestral Wuhan variant seems to close. That would suggest to me, that 1273 should have similar efficacy versus the South African and the Wuhan variance. Am I interpreting it the same way you are? Or am I missing something?

其次，也許在科學上，更有趣的是，您如何解釋數據表明至少對於強生的腺病毒方法，以及您自己的數據和其他 mRNA 疫苗，滴度似乎隨著時間的推移和細胞免疫而改善隨著時間的推移，對所謂的南非變異和祖傳武漢變異的療效差距似乎正在縮小。這對我來說意味著 1273 與南非和武漢的差異應該具有相似的功效。我的解釋和你一樣嗎？還是我錯過了什麼？

Yes. So maybe I'll cover the first one. On the tax rate, as I said, what happens is we're carrying this net operating loss with a full valuation reserve right now against the deferred tax asset that comes with it. So that will, of course, get released as we start [generating] pretax income. And it's likely based on the current book of business that we would consume during the year the entire loss carryforward. So that's point one.

是的。所以也許我會介紹第一個。正如我所說，在稅率方面，我們現在用全額估值儲備來承擔這一淨經營虧損，以抵消隨之而來的遞延稅項資產。因此，當我們開始[產生]稅前收入時，這當然會被釋放。它很可能基於我們將在這一年中消耗的整個虧損結轉的當前業務賬簿。這就是第一點。

Point two is from an accounting perspective, what happens is you basically project the full year tax rate, including the consumption of that deferred tax asset. And then you start accounting quarter-by-quarter based on that average of the full year rate. So it actually, from an accounting perspective, doesn't matter, the timing of the release of the NOL, the deferred tax asset and the valuation reserve. So that's why I tried to be clear with the mid-teen percentage, including in Q1, because from an accounting perspective, it will -- it would be stable unless we have some other changes that caused the full year rate to change as we move forward. Hopefully, that's clear.

第二點是從會計的角度來看，你基本上會預測全年的稅率，包括遞延稅資產的消耗。然後你開始根據全年平均利率逐個季度進行核算。所以實際上，從會計的角度來看，NOL、遞延所得稅資產和估值準備金的發佈時間並不重要。所以這就是為什麼我試圖明確青少年百分比，包括第一季度，因為從會計的角度來看，它將是穩定的，除非我們有一些其他變化導致全年利率隨著我們的移動而變化向前。希望這很清楚。

That's clear. I misstated my question. I actually meant versus severe disease mortality in terms of the similarity and efficacy alone. I thought of a longer-term follow-up.

這很清楚。我錯誤地陳述了我的問題。實際上，僅就相似性和功效而言，我的意思是與嚴重疾病死亡率相比。我想到了一個更長期的後續行動。

Sure. Yes. So thank you for that question. So let me take a stab at it. I think we're -- as you noted, I mean, we had nearly or essentially 100% of efficacy against severe disease, 94% against moderate or any disease. And I think that gives us great optimism about the current 1273 vaccine that's been authorized is protecting and even if the new strains are slightly more virulent, that we'll be in good shape.

當然。是的。所以謝謝你的問題。所以讓我試一試。我認為我們 - 正如你所指出的，我的意思是，我們對嚴重疾病的療效幾乎或基本為 100%，對中度或任何疾病的療效為 94%。我認為這讓我們對目前已獲授權的 1273 疫苗具有保護作用感到非常樂觀，即使新毒株的毒性稍強，我們也會處於良好狀態。

I think the question, though, is at some point, you would expect coronavirus immunity to wane. And that's because in all of the human circulating coronaviruses, that's what happens. The durability here has always been a question. Is it 1 year? Is it 3 years? Is it 5 years? I think as you see new strains emerge, like the potentially concerning strains that we've been talking about, particularly in the Republic of South Africa and Brazil, you have to ask the question, is that -- what does that look like not just now, but what does that look like 6 months from now, 1 year from now, as we start to move into a mode where we're going to see seasonal epidemics of coronaviruses, which we already see for the other coronaviruses, and you would have to assume will happen with SARS-CoV-2.

不過，我認為問題在於，在某些時候，您會期望冠狀病毒的免疫力會減弱。那是因為在所有人類傳播的冠狀病毒中，都會發生這種情況。這裡的耐用性一直是一個問題。是1年嗎？是3年嗎？是5年嗎？我認為當你看到新的菌株出現時，比如我們一直在談論的可能令人擔憂的菌株，特別是在南非共和國和巴西，你必須問一個問題，那就是——這看起來不僅僅是現在，但是從現在起 6 個月、1 年後，隨著我們開始進入一種模式，我們將看到冠狀病毒的季節性流行，我們已經在其他冠狀病毒中看到了這種流行，你會不得不假設 SARS-CoV-2 會發生。

And it's for that -- it's those gaps in immunity that I think we're particularly focused on right now, which is, to what extent do you -- to what extent in the future do at-risk populations emerge with increased risk against these new strains? It's not something you can see in the data in the first 30, 60, 90 days post vaccination in the current clinical trials. But it's something that you -- we did talk a lot about last year, and I think it's going to continue to be something we have to track closely as we look ahead.

正是因為如此——我認為我們現在特別關注的是免疫方面的差距，也就是說，你在多大程度上——在未來，高危人群會在多大程度上出現這些疾病的風險增加新菌株？在當前的臨床試驗中，這不是您在疫苗接種後前 30、60、90 天的數據中看到的。但這是你 - 去年我們確實談論了很多，我認為這將繼續成為我們在展望未來時必須密切跟踪的事情。

That's helpful. I guess that would imply also that it might be useful to look at sero collected from the already vaccinated patients, 180, et cetera, further days out and perhaps perform the same experiment described in the New England Journal of Medicine article. Would you consider disclosing that data? Or do you think it just makes more sense to just move to your novel variant approaches? And just would the clinical data speak for itself?

這很有幫助。我想這也意味著，觀察從已經接種過疫苗的患者（180 人等）身上收集的血清可能會有所幫助，再過幾天，或許可以進行《新英格蘭醫學雜誌》文章中描述的相同實驗。你會考慮披露這些數據嗎？還是您認為只是轉向您的新穎變體方法更有意義？只是臨床數據會說話嗎？

So fair question. I mean, look, I think we will obviously update data on durability of responses across our Phase I, Phase II, Phase III trials as that comes out. And looking forward, it's prudent. And if we can, we will be providing updates as well against the new strains.

這麼公平的問題。我的意思是，看，我認為我們顯然會在第一階段、第二階段、第三階段試驗中更新關於響應持久性的數據。展望未來，這是謹慎的。如果可以的話，我們還將針對新菌株提供更新。

I think what we're saying about the variants and strategies against it is -- I think none of us want to be in a situation where we wait until there are reinfections and increased morbidity and, God forbid, more mortality in a seasonal epidemic, for instance, this winter in the Northern Hemisphere, this coming winter. And then say, okay, now it's time to be boosting people.

我認為我們所說的關於它的變種和策略是——我認為我們都不想處於這樣一種情況，即等待再次感染和發病率增加，並且，上帝保佑，在季節性流行病中死亡率更高，比如這個北半球的冬天，這個即將到來的冬天。然後說，好吧，現在是提升人們的時候了。

And so as we're continuing to face an evolving virus that is changing its stripes and perhaps decreasing the durability of our immunity, we're trying to be very proactive with the 3 strategies we described. And I think we'll continue to follow things like the data that you pointed to, which is how are we doing in terms of immunity and blood of people who've previously been vaccinated or previously infected. We'll obviously closely be following reinfections. And then I think we all have to be following very closely what's happening in the southern hemisphere, because as they move into their winter and a potential seasonal spike in the winter as you normally see in temperate climates, it will help us understand to what extent are we still in a -- we have to stay ahead in the concerning phase of this epidemic or pandemic or is it a place where we start to get more and more confident that the vaccines have the virus under control.

因此，當我們繼續面對一種不斷發展的病毒，這種病毒正在改變它的條紋，並可能降低我們的免疫力的持久性，我們正試圖非常積極地採用我們描述的 3 種策略。而且我認為我們將繼續關注您所指出的數據之類的數據，這就是我們在以前接種過疫苗或以前感染過的人的免疫力和血液方面的表現。我們顯然會密切關注再感染情況。然後我認為我們所有人都必須密切關注南半球正在發生的事情，因為隨著它們進入冬季並且在冬季可能出現季節性高峰，正如你通常在溫帶氣候中看到的那樣，這將有助於我們了解在多大程度上我們是否仍處於 - 我們必須在這一流行病或大流行的相關階段保持領先，還是我們開始越來越相信疫苗可以控制病毒。

At this time, I'll turn the call back over to Stéphane Bancel for closing remarks.

此時，我將把電話轉回給 Stéphane Bancel 以結束髮言。

Well, thank you very much, everybody, for joining us. We look forward to seeing you at our next event on April 14 for Vaccine Day, and I wish everybody to stay safe. Have a great day. Bye.

嗯，非常感謝大家加入我們。我們期待在 4 月 14 日的疫苗日活動中與您相見，並希望大家保持安全。祝你有美好的一天。再見。

Thank you, ladies and gentlemen, that concludes today's conference call. You may now disconnect.

謝謝各位，女士們，先生們，今天的電話會議到此結束。您現在可以斷開連接。