莫德納 (MRNA) 2020 Q1 法說會逐字稿

Good morning and welcome to Moderna's first quarter 2020 conference call. (Operator Instructions) Please be advised that the call is being recorded. At this time, I would like to turn the call over to Lavina Talukdar, Head, Investor Relations at Moderna. Please proceed.

早上好，歡迎參加 Moderna 2020 年第一季度電話會議。 （操作員說明）請注意，通話正在錄音。現在，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. Welcome to Moderna's conference call to discuss our first quarter 2020 business updates and financial results. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website.

謝謝你，接線員。大家，早安。歡迎參加 Moderna 的電話會議，討論我們 2020 年第一季度的業務更新和財務業績。您可以訪問我們網站的投資者部分，查看今天早上發布的新聞稿以及我們將審查的幻燈片。

Speaking on today's call are Stéphane Bancel, our CEO; Tal Zaks, our CMO; Stephen Hoge, our President; and Lorence Kim, our CFO.

我們的首席執行官 Stéphane Bancel 在今天的電話會議上發言。 Tal Zaks，我們的首席營銷官；斯蒂芬·霍格，我們的總裁；以及我們的首席財務官洛倫斯·金 (Lorence Kim)。

Before we begin, please note that this conference call will include forward-looking statements. 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，本次電話會議將包含前瞻性陳述。請參閱隨附演示文稿的幻燈片 2 以及我們向 SEC 提交的文件，了解可能導致我們的實際業績和結果與這些前瞻性聲明中明示或暗示的結果存在重大差異的重要風險因素。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。

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

現在，我將把電話轉給 Stéphane。

Thank you, Lavina, and good morning or good afternoon, everyone. Thank you for joining the call. I hope you and your families are in good health.

謝謝拉維娜，大家早上好或下午好。感謝您加入通話。我希望您和您的家人身體健康。

As you know, we believe mRNA has a potential to be a new class of medicines with the opportunity to address many unmet medical needs, with medicines with higher probability of technical success, with greater speed of research and clinical development versus traditional medicines and with better manufacturing capital efficiency and lower cost of goods than injectable recombinants.

如您所知，我們相信mRNA 有潛力成為一類新型藥物，有機會解決許多未滿足的醫療需求，該藥物技術成功的可能性更高，與傳統藥物相比，研究和臨床開發速度更快，並且具有更好的療效。與註射重組體相比，生產資本效率更高，商品成本更低。

Given the amounts of working with new technology, we have been laser-focused on managing risk: technology risk, biology risk, execution risk and financing risk.

考慮到新技術的使用量，我們一直專注於管理風險：技術風險、生物風險、執行風險和融資風險。

As many of you know, 2019 was an important inflection year for Moderna. We reported clinically validating data from key programs into other modalities, prophylactic vaccines and systemic secreted and cell surface therapeutics, data that we believe fundamentally changed the risk profile for each of these 2 modalities that we now call comodalities. As a result, our strategy is to double down in these 2 comodalities with many important new development candidates space.

眾所周知，2019 年對於 Moderna 來說是重要的轉折年。我們報告了從關鍵項目到其他模式、預防性疫苗以及系統分泌和細胞表面治療的臨床驗證數據，我們相信這些數據從根本上改變了這兩種模式（我們現在稱之為共模態）的風險狀況。因此，我們的策略是在這兩種共模態中加倍努力，並提供許多重要的新開發候選空間。

We have already announced 5 new development candidates in these comodalities since January 13 at the JPMorgan Conference: 3 new development candidates in infectious disease: prophylactic vaccines and 2 in the systemic secreted and cell surface therapeutics modality. While we focus on doubling down in comodalities, we are still very interested in understanding the potential of our mRNA technology in our current exploratory modalities: cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics and systemic intracellular therapeutics.

自1 月13 日摩根大通會議以來，我們已經宣布了這些共模態的5 個新開發候選藥物：傳染病領域的3 個新開發候選藥物：預防性疫苗和全身分泌和細胞表面治療模式的2個新開發候選藥物。雖然我們專注於加倍努力，但我們仍然非常有興趣了解我們的 mRNA 技術在當前探索模式中的潛力：癌症疫苗、腫瘤內免疫腫瘤學、局部再生治療和系統細胞內治療。

So when we think about the company, we basically have 2 distinct area of focus. This is a significant point in our strategy. We have comodalities we want to scale and invest and exploratory comodalities that continue to be a big driver to the company's future as we await clinical data to decide the path forward.

因此，當我們考慮公司時，我們基本上有兩個不同的重點領域。這是我們戰略中的一個重要點。當我們等待臨床數據來決定前進的道路時，我們有想要擴展和投資的共模態以及探索性的共模態，它們仍然是公司未來的重要推動力。

So stepping back, I would have to share with you the progress of the company toward a new class of medicines. This is a strategic plan that we shared with you in February 2020. In the early days of the company, our goal was to enter the clinic safely. We spent years investing and developing mRNA science, formulation delivery and manufacturing technologies. The company pivoted out of that growth phase when we entered the clinic with our H10 influenza vaccine in December 2015.

因此，退後一步，我必須與大家分享公司在新型藥物方面的進展。這是我們在2020年2月跟大家分享的一個戰略規劃。公司成立初期，我們的目標是安全進入診所。我們花了數年時間投資和開發 mRNA 科學、配方交付和製造技術。當我們於 2015 年 12 月將 H10 流感疫苗進入臨床時，公司就擺脫了這個增長階段。

In the clinic, our next goal was to learn how well our technology was working or not. We explored our technology across 6 different modalities. We tested 16 different molecules in the clinic in a short 4-year period. In 2019, we generated important data in 2 of these 6 modalities and identified our first 2 comodalities, infectious disease prophylactic vaccines and systemic secreted and cell surface therapeutics.

在診所中，我們的下一個目標是了解我們的技術是否有效。我們通過 6 種不同的方式探索了我們的技術。我們在短短 4 年的時間裡在診所測試了 16 種不同的分子。 2019 年，我們在這 6 種模式中的 2 種中生成了重要數據，並確定了我們的前 2 種共模態：傳染病預防疫苗以及系統分泌和細胞表面治療。

Early in the year, we entered a new phase of company's development. Our goal for this next phase in our history is to file multiple BLAs while continuing our clinical programs in the 4 exploratory modalities and continue to invest aggressively in early research to invent new modalities such as our ongoing collaboration with Vertex.

年初，我們進入了公司發展的新階段。我們下一階段的目標是提交多個 BLA，同時繼續我們的 4 種探索模式的臨床項目，並繼續積極投資於早期研究以發明新的模式，例如我們與 Vertex 的持續合作。

When we first presented this plan in early February this year, we had imagined that the next phase of growth of the company will have taken us 3 to 4 years. Our vaccine against SARS-CoV-2 virus, mRNA-1273, is a major acceleration of our company's development. Today, we are very happy to announce that we received yesterday clearance from the FDA to proceed with the Phase II. It's just 9 days from filing our IND on Monday, April 27, the FDA gave us a green light. We intend to start the clinical trial as soon as safely possible.

今年2月初，當我們第一次提出這個計劃時，我們曾設想公司下一階段的發展需要3到4年的時間。我們針對 SARS-CoV-2 病毒的疫苗 mRNA-1273 是我們公司發展的重大加速器。今天，我們非常高興地宣布，我們昨天收到了 FDA 的許可，可以繼續進行第二階段。距離 4 月 27 日星期一提交 IND 僅僅 9 天，FDA 就給我們開了綠燈。我們打算盡快安全地開始臨床試驗。

We've also announced this morning that we are finalizing the Phase III protocol. And our aim is to start dosing the Phase III in early summer 2020. This means that we have a potential for a BLA approval for mRNA-1273 in 2021. That is an acceleration of several years versus the plan we had just months ago. Moderna should be a commercial company -- sorry, Moderna should be a commercial-stage company in 2021. That is 2 to 3 years ahead of our previous plans, plans we outlined just months ago. This is a unique opportunity. So we are working actively to get the company ready.

今天早上我們還宣布我們正在敲定第三階段協議。我們的目標是在 2020 年初夏開始 III 期臨床試驗。這意味著我們有可能在 2021 年獲得 BLA 批准 mRNA-1273。與我們幾個月前的計劃相比，這已經提前了幾年。 Moderna 應該成為一家商業公司——抱歉，Moderna 應該在 2021 年成為一家商業階段的公司。這比我們之前的計劃（我們幾個月前概述的計劃）提前了 2 到 3 年。這是一個獨特的機會。因此，我們正在積極努力讓公司做好準備。

To deliver on this acceleration of the company's plan, we're expanding our leadership team in areas where their expertise will be instrumental to allow us to successfully file several BLAs and be ready commercially. Today, we are announcing 3 new addition to the leadership roles of Moderna. First, Patrick Bergstedt. Patrick joins Moderna as Senior Vice President, Commercial Vaccines. Patrick will report to me. Patrick joins from Merck & Co. where he most recently was Head of Global Marketing & Commercial Operations for the entire vaccine business at Merck. Patrick will start on June 1. Patrick led global initiatives with a focus on revenue growth and access expansion. The 20-plus year veteran in the biopharma industry, Patrick has held various leadership positions within the infectious disease and global health at Merck in the U.S., in Europe, but also in Asia.

為了加速公司的計劃，我們正在擴大我們的領導團隊，他們的專業知識將有助於我們成功提交多個 BLA 並做好商業準備。今天，我們宣布了 Moderna 的 3 名新領導職位。首先是帕特里克·伯格施泰特。 Patrick 加入 Moderna，擔任商業疫苗業務高級副總裁。帕特里克將向我匯報。 Patrick 在加入默克公司之前，曾擔任默克公司整個疫苗業務的全球營銷和商業運營主管。 Patrick 將於 6 月 1 日開始工作。Patrick 領導全球舉措，重點關注收入增長和准入擴展。 Patrick 在生物製藥行業擁有 20 多年的經驗，曾在美國、歐洲和亞洲的默克公司的傳染病和全球健康領域擔任過各種領導職務。

Second, Jacqueline Miller, Dr. Jacqueline Miller. Jacqueline will be joining Moderna on May 11 from GSK as Senior Vice President, Infectious Disease Development. Jacqueline joins the company from GSK where she held a variety of leadership roles since 2005. Most recently, Jacqueline was the Vice President and Head, Clinical R&D and Epidemiology, where she built and led the clinical and epidemiology research team at the first GSK vaccine research and development center in the U.S.

第二位，杰奎琳·米勒，杰奎琳·米勒博士。 Jacqueline 將於 5 月 11 日從 GSK 加盟 Moderna，擔任傳染病開發高級副總裁。 Jacqueline 在加入公司之前曾於GSK 自2005 年起擔任過多種領導職務。最近，Jacqueline 擔任副總裁兼臨床研發和流行病學負責人，她在GSK 的第一個疫苗研究中建立並領導了臨床和流行病學研究團隊美國的研發中心

And third, Dr. Charbel Haber. Charbel joined Moderna on April 21 as Senior Vice President for Regulatory Affairs. Charbel joined us from Biogen, where he served as Vice President, Global Safety and Regulatory Sciences since 2017. In this role, he built and led the Global Regulatory Strategy Department, the clinical trial application group and the Medical Writing group. Prior to Biogen, Dr. Haber, was Head, Global Regulatory Affairs-Immunology and Neurology at EMD Serono.

第三位是查貝爾·哈伯博士。 Charbel 於 4 月 21 日加入 Moderna，擔任監管事務高級副總裁。 Charbel 在加入我們之前曾在百健(Biogen) 公司工作，自2017 年起擔任全球安全和監管科學副總裁。在此職位上，他建立並領導了全球監管戰略部門、臨床試驗應用小組和醫學寫作小組。在加入 Biogen 之前，Haber 博士曾擔任 EMD Serono 免疫學和神經病學全球監管事務主管。

I am very excited to welcome Patrick, Jacqueline and Charbel and look forward to their contribution at Moderna as we embark on the commercial stage phase of our company. It is a bittersweet moment to announce today the departure from the company of Dr. Lorence Kim, our Chief Financial Officer. Lorence joined the company in 2014 when the company was private. As some of you remember, it was a preclinical stage company with 0 development candidates. Lorence super-chanced on Stephen Hoge and I and decided to leave a great job by Goldman Sachs to join us. The company is now public with 23 development candidates and preparing its first Phase III. Lorence will manage with us for a smooth transition. He will do Moderna second quarter conference call in August with us before leaving the company. I am very thankful for Lorence's contribution over the years and for the constructive discussion he and I had about entering a smooth transition. There is never a good time for leadership transitions, but the company is very well capitalized with around $2.4 billion of capital to invest to create value. And we need to focus on the next phase of readiness for the company to be commercial. We have retained Russell Reynolds for the search for Moderna's next CFO. We will focus on a CFO who has public company and commercial and global operation experience, given this is where Moderna is heading.

我非常高興地歡迎帕特里克、杰奎琳和查貝爾，並期待他們在我們公司進入商業階段時為 Moderna 做出貢獻。今天宣布我們的首席財務官 Lorence Kim 博士離開公司，這是一個苦樂參半的時刻。 Lorence 於 2014 年加入公司，當時該公司還是私營公司。正如你們中的一些人所記得的那樣，這是一家臨床前階段的公司，開發候選者為 0。洛倫斯（Lorence）對斯蒂芬·霍格（Stephen Hoge）和我非常有信心，並決定辭去高盛（Goldman Sachs）的出色工作加入我們。該公司現已公開了 23 個候選開發項目，並正在準備其第一個 III 期項目。洛倫斯將與我們一起努力實現平穩過渡。在離開公司之前，他將於 8 月份與我們一起參加 Moderna 第二季度的電話會議。我非常感謝洛倫斯多年來的貢獻，以及他和我就平穩過渡進行的建設性討論。領導層換屆從來都不是一個好時機，但該公司資本充足，約有 24 億美元的資本可用於投資創造價值。我們需要專注於公司下一階段的商業準備工作。我們保留了 Russell Reynolds 來尋找 Moderna 的下一任首席財務官。鑑於 Moderna 的發展方向，我們將重點關注具有上市公司以及商業和全球運營經驗的首席財務官。

Before I hand over to Tal for clinical updates, I wanted to take a few minutes to frame the opportunity in our vaccine modality. We believe mRNA has the potential to be a new class of vaccines, where each of the 4 drivers of value apply. We are very excited about the potential of our vaccines to drive this value. First, as we discussed, a very large opportunity, the ability to do first-in-class vaccines that do not have products on the market today to protect as many people as we can. Second, a relatively high probability of technical success. As we discussed at our Vaccine Day, Dr. Andrew Lo from MIT has shown that from the start of a Phase II, i.e., post the Phase I, to approval, vaccines have 42% probability of approval. This is the highest probability amongst all categories of medicines in clinical trial. We think this is a very important value driver for this franchise.

在交給塔爾進行臨床更新之前，我想花幾分鐘時間來框架一下我們的疫苗模式中的機會。我們相信 mRNA 有潛力成為一類新型疫苗，四個價值驅動因素均適用。我們對我們的疫苗推動這一價值的潛力感到非常興奮。首先，正如我們所討論的，這是一個非常大的機會，能夠生產目前市場上沒有產品的一流疫苗，以保護盡可能多的人。其次，技術成功的概率比較高。正如我們在疫苗日討論的那樣，麻省理工學院的 Andrew Lo 博士表明，從第二階段開始，即第一階段之後，到獲得批准，疫苗獲得批准的概率為 42%。這是臨床試驗中所有類別藥物中概率最高的。我們認為這是該特許經營權非常重要的價值驅動因素。

Further, we think an important driver is speed, speed in the labs. Even we have a platform. We can study many candidates in parallel in preclinical setting. Most difficult development candidates to take into the clinic, we can do it very quickly, as we have shown recently with SARS-CoV-2 vaccine, going from design of a vaccine on January 13 to injecting the first human on March 16 in as little as 63 days.

此外，我們認為一個重要的驅動因素是速度，實驗室的速度。即使我們有一個平台。我們可以在臨床前環境中並行研究許多候選藥物。最困難的開發候選藥物進入臨床，我們可以非常快地做到這一點，正如我們最近在SARS-CoV-2 疫苗上所展示的那樣，從1 月13 日設計疫苗到3 月16 日第一例人體注射，只需短短的時間為 63 天。

Finally, we believe the capital efficiency of our platform offers significant advantages over traditional vaccines. Because the manufacturing process to make mRNA molecule is a cell-free manufacturing process, it can drive much lower CapEx versus recombinant protein manufacturing. The second dimension is the CapEx leverage across value chain. For example, when we decided to go after SARS-CoV-2, we did not have to buy any new machine. Our team was able to leverage existing CapEx in a matter of days.

最後，我們相信我們平台的資本效率比傳統疫苗具有顯著優勢。由於製造 mRNA 分子的製造過程是無細胞製造過程，因此與重組蛋白製造相比，它可以大大降低資本支出。第二個維度是整個價值鏈的資本支出槓桿。例如，當我們決定追擊 SARS-CoV-2 時，我們不需要購買任何新機器。我們的團隊能夠在幾天內利用現有的資本支出。

With that overview, let me now turn over to Tal. Tal?

有了這個概述，現在讓我向塔爾求助。塔爾？

Thank you, Stéphane, and good morning, everyone. I'll start with a quick reminder on the data generated to date with our vaccines.

謝謝你，斯特凡，大家早上好。首先，我將快速提醒一下我們的疫苗迄今為止生成的數據。

In over 1,500 healthy volunteers and 7 positive Phase I data sets to date, we have observed a safety profile that's consistent with the safety of adjuvanted vaccines. And we've time and again demonstrated the ability to elicit an immune response in the form of neutralizing antibodies.

迄今為止，在超過 1,500 名健康志願者和 7 個陽性 I 期數據集中，我們觀察到了與佐劑疫苗的安全性一致的安全性。我們一次又一次地證明了以中和抗體的形式引發免疫反應的能力。

I'll start with a high-level progress on mRNA-1273, our vaccines against SARS CoV-2, and will give more detail shortly. As you heard from Stéphane earlier, we have the FDA clearance to move into our Phase II study, and we plan to start it shortly. This study will run in parallel with the NIH-run Phase I study, which has completed enrollment of the first 3 dose cohorts. Our CMV Phase II dose confirmation study is fully enrolled, and we still expect data readout to come in the third quarter of this year, despite having had some COVID-19-related disruptions.

我將從 mRNA-1273（我們的針對 SARS CoV-2 的疫苗）的高水平進展開始，並將很快提供更多細節。正如您之前從 Stéphane 那裡聽到的，我們已獲得 FDA 批准進入 II 期研究，並且我們計劃很快開始。這項研究將與 NIH 運行的 I 期研究同時進行，該研究已完成前 3 個劑量組的入組。我們的 CMV II 期劑量確認研究已全部入組，儘管出現了一些與 COVID-19 相關的中斷，但我們仍預計數據讀出將在今年第三季度進行。

At our Vaccines Day on April 14, we announced positive interim analysis of our Phase I study for our Zika vaccine. At the 2 lower doses of 10 microgram and 30 microgram, we achieved seroconversion rates of 94% and 100%, respectively. The 2 higher dose cohorts of 100 microgram and 250 microgram are now fully enrolled. As a reminder, we paused our hMPV/PIV3 Phase Ib study enrollment as a cautionary measure to protect children and their caregivers due to COVID-19 disruptions. Our RSV program with Merck continues.

在 4 月 14 日的疫苗日上，我們宣布了寨卡疫苗 I 期研究的積極中期分析。在 10 微克和 30 微克 2 個較低劑量下，我們分別實現了 94% 和 100% 的血清轉化率。 100 微克和 250 微克的 2 個較高劑量組現已全部入組。謹此提醒，我們暫停了 hMPV/PIV3 Ib 期研究招募，作為一項謹慎措施，以保護因 COVID-19 造成的兒童及其看護者。我們與默克的 RSV 計劃仍在繼續。

So this has been covered in detail, but just to quickly pace everybody on the same place, our SARS-CoV-2 vaccine, mRNA-1273, which was a subject of much work and discussion in the first quarter of this year, demonstrates the kind of speed that we believe the platform can provide, from first selection of a sequence by our scientists and our collaborators at NIAID on January 13 to the production of a clinical batch on February 7, 25 days later. That had been released by February 24, and by March 4, was associated with an open IND that NIAID had filed. The strong collaboration between us and NIAID led to this -- the trial opening within 63 days, and we've spoken about this before.

我們已經詳細介紹了這一點，但只是為了讓大家快速齊心協力，我們的 SARS-CoV-2 疫苗 mRNA-1273 是今年第一季度大量工作和討論的主題，它證明了我們相信該平台可以提供這樣的速度，從我們的科學家和NIAID 的合作者在1 月13 日首次選擇序列，到25 天后的2 月7 日生產臨床批次。該信息已於 2 月 24 日發布，並於 3 月 4 日發布，與 NIAID 提交的公開 IND 相關。我們和 NIAID 之間的密切合作促成了這一結果——試驗在 63 天內開放，我們之前已經談到過這一點。

On April 17, we were awarded a contract from the U.S. government agency, BARDA, to accelerate the development. And on April 27, we announced an IND was submitted to the U.S. FDA for the Phase II study. Last Friday, we announced a collaboration with Lonza to manufacture mRNA-1273 at scale, with the goal of producing up to 1 billion doses a year. And of course, today, we announced the FDA clearance to start the Phase II part.

4月17日，我們獲得了美國政府機構BARDA的合同，以加速開發。 4 月 27 日，我們宣布向美國 FDA 提交 IND 進行 II 期研究。上週五，我們宣布與 Lonza 合作大規模生產 mRNA-1273，目標是每年生產多達 10 億劑。當然，今天我們宣布 FDA 批准啟動第二階段部分。

In parallel, we have been working on the Phase III protocol, and we are finalizing that with an aim to start the study in the summer of 2020. The design of the Phase I study is on Slide 17. The study started as a 45-subject trial with 3 dose cohorts, 25, 100 and 250 microgram, with each participant receiving 2 vaccinations a month apart. Phase III dose cohorts have now been fully enrolled, and the safety and immunogenicity data from them will be shared when available. The NIH is expanding the trial to include 2 additional age cohorts, a 56- to 70-year-old cohort and a 71-and-above age cohort. Each of these age cohorts will include 3 dose levels also at 25, 100 and 250 microgram at the same vaccination schedule.

與此同時，我們一直在製定第三階段方案，我們正在最終確定該方案，目標是在 2020 年夏季開始研究。第一階段研究的設計位於幻燈片 17 上。該研究以 45-受試者試驗分為3 個劑量組，分別為25、100 和250 微克，每個參與者每月接種2 次疫苗。 III 期劑量隊列現已全部入組，其安全性和免疫原性數據將在可用時進行共享。 NIH 正在擴大試驗範圍，納入另外 2 個年齡組，即 56 至 70 歲組和 71 歲及以上年齡組。這些年齡組中的每一個都將在相同的疫苗接種計劃中包括 25、100 和 250 微克的 3 個劑量水平。

In terms of the late phase development for mRNA-1273, as mentioned before, the Phase II study is expected to start shortly. This study will evaluate the safety, reactogenicity and immunogenicity of 2 vaccinations of mRNA-1273 given 1-month apart. Volunteers will receive either placebo, 50 or 250 micrograms at both vaccinations. This study will enroll 600 healthy participants and 2 cohorts of adults, ages 18 to 55 and 55-year-old-and-above. The study is meant to both increase our safety database as well as confirm the immunogenicity seen in the phase that we expect to see in the Phase I. We are finalizing, as I said, the Phase III protocol, and the study is expected to begin this summer.

至於mRNA-1273的後期開發，如前所述，II期研究預計很快就會開始。本研究將評估間隔 1 個月接種 2 次 mRNA-1273 疫苗的安全性、反應原性和免疫原性。志願者在兩次疫苗接種時都將接受 50 微克或 250 微克的安慰劑。這項研究將招募 600 名健康參與者和 2 組成年人，年齡分別為 18 至 55 歲和 55 歲及以上。該研究旨在增加我們的安全性數據庫，並確認我們期望在第一階段中看到的免疫原性。正如我所說，我們正在敲定第三階段方案，研究預計將開始這個夏天。

Last week, Moderna and Lonza announced a strategic collaboration with the goal to enable manufacturing of up to 1 billion doses a year, and this is assuming a dose of 50 micrograms. Technology transfer is expected to begin this June, and we anticipate the first batches of mRNA-1273 to be manufactured at Lonza's U.S. sites in July of this year. I would be remiss not to mention BARDA's role in this. The BARDA award is allowing for us to move as quickly as we are with scale-up, both internally and with Lonza.

上週，Moderna 和 Lonza 宣布了一項戰略合作，目標是每年生產多達 10 億劑疫苗，假設劑量為 50 微克。技術轉讓預計將於今年 6 月開始，我們預計第一批 mRNA-1273 將於今年 7 月在 Lonza 的美國工廠生產。如果我不提及 BARDA 在這方面的作用，那就太失職了。 BARDA 獎項使我們能夠盡快擴大規模，無論是內部還是與 Lonza 合作。

Moving on to CMV. Slide 20 reviews our late-stage development plans for CMV. As previously announced, the Phase II dose confirmation study is fully enrolled, and we remain on track for data readout in the third quarter of 2020. Importantly, greater than 70% of participants have now received their second vaccine dose. A protocol amendment was submitted to expand the time frame for the remaining participants to receive their second dose as well. As a reminder, we plan to select a dose for the Phase III after the first interim analysis, which is the data post the second vaccination. We continue to prepare for the Phase III, which is intended to start in 2021 in the U.S. and Europe. During the first quarter of '20, we also received constructive feedback from the Type C CMC meeting that we've had with the FDA.

繼續 CMV。幻燈片 20 回顧了我們的 CMV 後期開發計劃。正如之前宣布的那樣，II 期劑量確認研究已全部入組，我們仍有望在 2020 年第三季度讀出數據。重要的是，超過 70% 的參與者現已接受第二劑疫苗。提交了一項方案修正案，以延長其餘參與者接受第二劑疫苗的時間範圍。提醒一下，我們計劃在第一次中期分析後選擇第三階段的劑量，這是第二次疫苗接種後的數據。我們繼續為第三階段做準備，該階段計劃於 2021 年在美國和歐洲啟動。在 20 世紀 20 年代第一季度，我們還收到了與 FDA 舉行的 C 型 CMC 會議的建設性反饋。

Moving on to mRNA-1893, our Zika vaccine program. Let me recap on Slide 24 the data that we recently presented at our Vaccines Day, where we reported an interim analysis of the ongoing Phase I trial. This study has demonstrated a fairly benign safety profile, consistent with what we've seen before for other vaccines. And at the 2 lower doses of 10 and 30 micrograms after a 2 dose vaccination regimen, prime and boost, the seroconversion rates were 94% and 100%, respectively. These data are encouraging, and we are preparing to move forward with this program into a Phase II trial.

接下來是 mRNA-1893，我們的寨卡疫苗計劃。讓我在幻燈片 24 上回顧一下我們最近在疫苗日上提供的數據，其中我們報告了正在進行的第一階段試驗的中期分析。這項研究證明了相當良好的安全性，與我們之前在其他疫苗中看到的情況一致。在 2 劑疫苗接種方案（初免和加強）後，在 10 和 30 微克的 2 個較低劑量下，血清轉化率分別為 94% 和 100%。這些數據令人鼓舞，我們正準備將該計劃推進到二期試驗。

The exploratory modalities are a critical part of our strategy, and we continue to make up a significant part of what we do in the clinic. And on Slide 26, you see a -- if you scan the page, you'll see many readouts and catalysts from each of the programs, both from our core modalities as well as the exploratory ones.

探索模式是我們戰略的重要組成部分，並且我們繼續在臨床工作中佔據重要組成部分。在幻燈片 26 上，您會看到 - 如果您掃描頁面，您會看到每個程序的許多讀數和催化劑，包括我們的核心模式和探索性模式。

With that, let me now turn the call over to Lorence.

現在讓我把電話轉給洛倫斯。

Thank you, Tal. Let me first cover an update on the Vertex agreement. In July 2016, we entered into a strategic collaboration and license agreement with Vertex in that discovery and development of potential mRNA medicines for the treatment of cystic fibrosis or CF by enabling cells in the lungs that people see us to potentially produce functional CFTR proteins. In July of 2019, the initial research term was extended by 6 months. And based upon promising preclinical data generated, in March of 2020, we were pleased that Vertex elected to extend this collaboration for a further 18 months.

謝謝你，塔爾。首先讓我介紹一下 Vertex 協議的最新情況。 2016 年 7 月，我們與 Vertex 簽訂了戰略合作和許可協議，通過使人們看到的肺部細胞能夠產生功能性 CFTR 蛋白，發現和開髮用於治療囊性纖維化或 CF 的潛在 mRNA 藥物。 2019年7月，初步研究期限延長6個月。基於 2020 年 3 月生成的有希望的臨床前數據，我們很高興 Vertex 選擇將這種合作再延長 18 個月。

Now let me turn to financial results. In today's press release, we reported our first quarter 2020 financial results. Note that these results are unaudited.

現在讓我談談財務業績。在今天的新聞稿中，我們報告了 2020 年第一季度的財務業績。請注意，這些結果未經審計。

We raised approximately $550 million in net proceeds from the February public equity offering, which resulted in us ending Q1 2020 with cash, cash equivalents and investments of $1.72 billion. This compares to $1.26 billion at the end of 2019. Net cash used in operating activities was $106 million for the first quarter of 2020 compared to $144 million in 2019. And just as a reminder, that latter number includes an in-licensing payment of $22 million, which will not recur. Cash used for purchases of property and equipment was $6 million for the first quarter of 2020 compared to $8 million in 2019.

我們從 2 月份的公開股票發行中籌集了約 5.5 億美元的淨收益，這使得我們在 2020 年第一季度末擁有 17.2 億美元的現金、現金等價物和投資。相比之下，2019 年底為 12.6 億美元。2020 年第一季度經營活動使用的淨現金為 1.06 億美元，而 2019 年為 1.44 億美元。提醒一下，後一個數字包括 22 美元的許可付款萬元，不會再發生。 2020 年第一季度用於購買財產和設備的現金為 600 萬美元，而 2019 年為 800 萬美元。

Revenue for the first quarter of 2020 was $8 million compared to $16 million in 2019. This decrease of $8 million in revenue was mainly due to cumulative catch-up adjustments resulting from changes in our estimated costs for our future performance obligations, coupled with the timing of amortization of deferred revenue due to the satisfaction of our performance obligations.

2020 年第一季度的收入為 800 萬美元，而 2019 年為 1600 萬美元。收入減少 800 萬美元主要是由於我們對未來履約義務的估計成本的變化以及時間安排的變化而導致的累積追趕調整。由於履行我們的履約義務而攤銷的遞延收入。

R&D expenses for the first quarter of 2020 were $115 million compared to $130 million in 2019. The decrease of $15 million in R&D was mainly driven by a decrease in lab supplies and materials and clinical trial and manufacturing costs, partially offset by personnel-related costs. G&A expenses for the first quarter of 2020 were $24 million compared to $27 million in Q1 2019. This decrease of $3 million was primarily attributable to decreases in legal and other consulting and outside services spend. And net loss for Q1 2020 was $124 million compared to $133 million in Q1 2019.

2020 年第一季度的研發費用為1.15 億美元，而2019 年為1.3 億美元。研發費用減少1500 萬美元，主要是由於實驗室用品和材料以及臨床試驗和製造成本的減少，部分被人員相關成本所抵消。 2020 年第一季度的一般管理費用為 2400 萬美元，而 2019 年第一季度為 2700 萬美元。減少 300 萬美元的主要原因是法律和其他諮詢以及外部服務支出的減少。 2020 年第一季度的淨虧損為 1.24 億美元，而 2019 年第一季度的淨虧損為 1.33 億美元。

I'll turn now to what we expect for the remainder of 2020. If you look at our cash flow line items, you can see our cash used in operating activities and purchases of property and equipment by quarter are laid out here. In Q1 of 2020, we used $112 million of cash on these 2 items, which is in line with our expectations. If you go back to Q1 2019, we used $152 million of cash on these 2 items. And remember again, that number included that licensing payment.

現在我將談談我們對 2020 年剩餘時間的預期。如果您查看我們的現金流量項目，您可以看到這裡列出了我們用於經營活動以及按季度購買財產和設備的現金。 2020年第一季度，我們在這兩項上使用了1.12億美元的現金，這符合我們的預期。如果你回到 2019 年第一季度，我們在這兩項上使用了 1.52 億美元的現金。再次記住，這個數字包括許可費用。

Overall, you can see the decline in our quarter-over-quarter cash used for these items through Q4 2019 with a slight uptick in Q1 2020. And so consistent with our initial 2020 guidance, which we issued back in November, we expect our 2020 net cash used in operating activities and purchases of property and equipment to be approximately $500 million. While we have seen parts of our spend slow down as a result of the impact of COVID-19, such as certain clinical trial expenses and laboratory supplies, we are also investing in preparedness for the late-stage development and potential BLA filing for our COVID vaccine. That results in bringing our cash flow guidance back to its original levels.

總體而言，您可以看到，截至2019 年第四季度，我們用於這些項目的現金環比下降，而2020 年第一季度略有上升。因此，與我們11 月發布的2020 年初步指導一致，我們預計2020 年用於經營活動以及購買財產和設備的現金淨額約為5億美元。雖然我們看到部分支出因 COVID-19 的影響而放緩，例如某些臨床試驗費用和實驗室用品，但我們也在投資為後期開發和潛在的 COVID-19 BLA 申請做好準備疫苗。這導致我們的現金流指引回到原來的水平。

We recognize that much of our COVID vaccine spend is covered by the BARDA award. Note that the award is not cash upfront but rather reimbursement as expenses are incurred. We do expect to incur significant expenses this year in relation to that BARDA award, but we expect in general a matching of expenses and reimbursements.

我們認識到，我們的大部分新冠疫苗支出均由 BARDA 獎項支付。請注意，該獎勵不是預付現金，而是在發生費用時進行報銷。我們確實預計今年會因 BARDA 獎項而產生大量費用，但我們預計總體上費用和報銷是匹配的。

Let's go down next on our balance sheet strength and the composition of the $2.4 billion of cash and available funding we have to invest and create value. We ended Q1 2020 with cash, cash equivalents and investments of $1.72 billion. On April 16, 2020, we entered into an agreement with BARDA to accelerate development of our mRNA vaccine candidate against the novel coronavirus for funding of up to $483 million, of which $430 million has been committed.

接下來讓我們看看我們的資產負債表實力以及我們用於投資和創造價值的 24 億美元現金和可用資金的構成。截至 2020 年第一季度，我們的現金、現金等價物和投資為 17.2 億美元。 2020 年 4 月 16 日，我們與 BARDA 達成協議，加速開發針對新型冠狀病毒的 mRNA 候選疫苗，資助金額高達 4.83 億美元，其中 4.3 億美元已承諾。

Additionally, we are fortunate to have established strategic alliances with private- and government-sponsored organizations, including the Bill and Melinda Gates Foundation, DARPA and another BARDA award comprising additional available funding of $180 million. Together, this creates multiple years of cash runway, considering the cash guidance that we shared today, and a strong ability to invest for the long run in many aspects of the business.

此外，我們很幸運地與私人和政府贊助的組​​織建立了戰略聯盟，包括比爾和梅琳達·蓋茨基金會、DARPA 和另一個包含 1.8 億美元額外可用資金的 BARDA 獎項。考慮到我們今天分享的現金指導，以及在業務的許多方面進行長期投資的強大能力，這共同創造了多年的現金跑道。

The next slide shows our pipeline and the programs through the various phases of development with a snapshot here.

下一張幻燈片展示了我們的流程和各個開發階段的程序，並附有快照。

But before I turn it back to Stéphane, let me just reiterate an important point from my announced departure this morning, which is that I expect to seamlessly transition my responsibilities through August. But I'll make a brief remark now. First of all, I'm so grateful to have been invited to be a part of this company, what an opportunity to contribute to Moderna's mission of turning mRNA into a new class of medicines. I joined the company 6 years ago, at a time when this story was nascent and the future was full of unknowns. I'm leaving now as the company has multiple BLAs on the horizon with 23 important new potential medicines in the pipeline and I believe many more to come. We've invested heavily in the platform to establish the scientific foundations of this new class of medicines, and the team is growing with unbelievable new talent.

但在我把問題轉回到 Stéphane 之前，讓我重申一下我今天早上宣布離職時的一個重要觀點，那就是我希望在 8 月份之前無縫地過渡我的職責。但我現在要簡單說一下。首先，我非常感激能夠受邀加入這家公司，這是一個為 Moderna 將 mRNA 轉變為新型藥物的使命做出貢獻的機會。我六年前加入公司，當時這個故事剛剛萌芽，未來充滿未知。我現在要離開，因為公司即將有多個 BLA，其中有 23 種重要的新潛在藥物正在研發中，而且我相信還會有更多藥物出現。我們在該平台上投入了大量資金，以建立此類新型藥物的科學基礎，並且該團隊正在不斷壯大，擁有令人難以置信的新人才。

I'm personally most proud of the financial foundation we've built to enable the company to invest appropriately in the business. It's been energizing and motivating to partner with Stéphane, the Board, its executive team and the passionate Moderna employee base. For me, I'm going to take the next step in my career, which will be to stay close to innovation in biotech, but not as a company executive. I look forward to sharing more about these plans at an appropriate time down the road with many of you on this call.

我個人對我們為使公司能夠適當投資業務而建立的財務基礎感到最自豪。與 Stéphane、董事會、執行團隊和熱情的 Moderna 員工群合作一直充滿活力和動力。對我來說，我將在職業生涯中邁出下一步，即密切關註生物技術的創新，但不是作為公司高管。我期待著在未來的適當時間與本次電話會議中的許多人分享有關這些計劃的更多信息。

And with that, I'll turn it over to Stéphane for closing remarks.

接下來，我將把它交給 Stéphane 做結束語。

Lorence, thanks again for your remarks. But having you as my partner for those 6 years has been quite a incredible ride.

洛倫斯，再次感謝您的發言。但有你作為我的合作夥伴，這六年的經歷真是令人難以置信。

On Slide 34, let me close by giving you a quick update where the company stands today, starting with our pipeline. It's exciting to see that today, we have 2 candidates for which we are preparing for Phase III, our CMV vaccine and our SARS-CoV-2 vaccine. We have now 6 candidates that are either in Phase II or preparing for Phase II. 12 Phase I programs and 11 positive Phase I result. What an acceleration since our IPO in December 2018.

在幻燈片 34 上，讓我從我們的管道開始，向您快速介紹一下公司目前的最新情況。令人興奮的是，今天我們有兩種候選疫苗正在為 III 期做準備：我們的 CMV 疫苗和我們的 SARS-CoV-2 疫苗。我們現在有 6 名候選者，他們要么處於第二階段，要么正在為第二階段做準備。 12 個 I 期項目和 11 個 I 期陽性結果。自 2018 年 12 月 IPO 以來，我們的發展速度多麼快啊。

Our programs are very exciting. We have 7 first-in-class vaccines, where there are no approved vaccines on the market against those viruses. Most of these vaccine candidates have multibillion-dollar annual peak sales opportunity. As we shared at our Vaccine Day presentation, we believe our innovative vaccines are going to be a very large business for Moderna with long-term annuity life opportunities at a high EBIT margin. We also have 5 exciting immuno-oncology programs that are already in the clinic, that are all combined with a commercial checkpoint, 4 rare disease program and 2 autoimmune disease programs.

我們的節目非常令人興奮。我們有 7 種一流疫苗，但市場上還沒有針對這些病毒的批准疫苗。大多數候選疫苗都有數十億美元的年度銷售高峰機會。正如我們在疫苗日演講中分享的那樣，我們相信我們的創新疫苗將成為 Moderna 的一項非常大的業務，並提供長期年金人壽機會和高息稅前利潤。我們還有 5 個令人興奮的免疫腫瘤學項目已經在臨床，它們都與商業檢查點、4 個罕見疾病項目和 2 個自身免疫性疾病項目相結合。

The company has never been stronger and look at an formations. We have now dosed more than 1,900 healthy volunteers and patients in our studies. The team is strong and getting stronger every month. We now have more than 900 employees who care deeply about our mission and are proud and energized by our progress and the meaning of our work.

該公司從未如此強大，看看陣型。目前，我們已對 1,900 多名健康志願者和患者進行了研究。該團隊很強大，並且每個月都在變得更強。我們現在擁有 900 多名員工，他們非常關心我們的使命，並對我們的進步和工作的意義感到自豪和充滿活力。

Last week, with the Lonza agreement, our manufacturing capabilities has changed league. We not only have a fully integrated GMP site in Massachusetts, who many of you know and have visited, but we've added a strategic partnership with Lonza that can enable us to up to 1 billion doses annually for vaccine against SARS-CoV-2, but also other products in our pipeline as we need to. We have great partners with AstraZeneca, Merck and Vertex. I am very proud of the scientific progress that the team of Stephen Hoge and Melisa Moore have done in the work with Vertex over the last few years. And we are very pleased that Vertex decided to expand the relationship with Moderna.

上週，隨著龍沙協議的簽署，我們的製造能力發生了變化。我們不僅在馬薩諸塞州擁有一個你們許多人都認識並參觀過的完全集成的GMP 工廠，而且我們還與Lonza 建立了戰略合作夥伴關係，這使我們能夠每年生產多達10 億劑SARS-CoV-2疫苗，以及我們需要的其他產品。我們與阿斯利康 (AstraZeneca)、默克 (Merck) 和福泰 (Vertex) 都有很好的合作夥伴。我對 Stephen Hoge 和 Melisa Moore 團隊過去幾年與 Vertex 合作取得的科學進步感到非常自豪。我們非常高興 Vertex 決定擴大與 Moderna 的關係。

But we're also very thankful for a partnership we've had over the years with BARDA, DARPA, [CP] and the Gates Foundation. And of course, we are very thankful for the latest partnership with BARDA, $483 million, to enable us to do the right clinical study as fast as we go, of course, focusing on safety first for the SARS-CoV-2 vaccine.

但我們也非常感謝多年來與 BARDA、DARPA、[CP] 和蓋茨基金會的合作夥伴關係。當然，我們非常感謝與 BARDA 的最新合作夥伴關係，價值 4.83 億美元，使我們能夠盡快進行正確的臨床研究，當然，重點是 SARS-CoV-2 疫苗的安全性第一。

And of course, we are well capitalized with up to $2.4 billion to invest in the business and continue to build the leading mRNA company in the world. We are very thankful for our investors for their trust and partnership as we build this unique company.

當然，我們資本充足，高達 24 億美元用於投資該業務，並繼續打造世界領先的 mRNA 公司。我們非常感謝投資者在我們建立這家獨特公司的過程中給予的信任和合作。

We are energized by the opportunity ahead of us to build a new class of medicines. We are currently accelerating our development pipeline and readying the company to potentially file its first BLA for mRNA-1273, which will be, as you can appreciate, a historic moment for the company. We're investing in the processes to get us there, to get the right foundations for potentially many additional BLAs in the future, starting with the Zika vaccine and CMV vaccines behind the SARS-CoV-2 mRNA-1273. We are already scaling up the organization to address the need to supply up to 1 billion doses for potentially first vaccine mRNA-1273. All those efforts, investment and processes will be very enabling for additional vaccines and therapeutics to come.

我們對面前構建新型藥物的機會感到充滿活力。我們目前正在加速我們的開發流程，並為公司可能提交第一份 mRNA-1273 BLA 做好準備，正如您所知，這將是公司的歷史性時刻。我們正在投資實現這一目標的流程，為未來潛在的許多其他 BLA 奠定正確的基礎，首先是 SARS-CoV-2 mRNA-1273 背後的寨卡疫苗和 CMV 疫苗。我們已經在擴大該組織的規模，以滿足為可能的第一種疫苗 mRNA-1273 提供多達 10 億劑疫苗的需求。所有這些努力、投資和流程都將非常有利於更多疫苗和治療方法的出現。

I have never been as excited and optimistic about the future of Moderna in the last 9 years. We are humbled and excited by the opportunity to bring forward a new class of medicines for patients. That has been our North Star since we started the company. I would like to thank the great team of Moderna employees working very hard every day, and literally, many of them 7 days a week now since January to fight the SARS-CoV-2 virus. I would like to thank the many people who participate in our clinical studies, including patients, healthy volunteers, physicians and nurses. I'd like to recognize all our partners that have worked with us to share our vision and helping us to achieve this vision to help patients.

過去 9 年來，我對 Moderna 的未來從未如此興奮和樂觀。我們對有機會為患者推出新型藥物感到謙卑和興奮。自我們成立公司以來，這一直是我們的北極星。我要感謝Moderna 偉大的員工團隊，他們中的許多人自1 月份以來每天都在努力工作，實際上，他們中的許多人自1 月份以來每週7 天都在努力抗擊SARS-CoV-2 病毒。我要感謝參與我們臨床研究的許多人，包括患者、健康志願者、醫生和護士。我要感謝所有與我們合作、分享我們的願景並幫助我們實現這一願景以幫助患者的合作夥伴。

With that, we are now happy to take any questions. Operator?

至此，我們現在很樂意回答任何問題。操作員？

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

（操作員說明）您的第一個問題來自摩根士丹利的馬修哈里森。

Great. I guess, first, you've highlighted the 50-microgram dose on the SARS-CoV-2 vaccine. And I think Dr. Fauci in his interview also talked about good responses in low doses in animals. Can you just talk about your confidence in being able to move forward and elicit the right kind of immune response with the low dose as opposed to the other doses that you're testing? And then secondly, can you just update us on where the field is and figuring out what neutralizing antibody titers are and if you think they'll be available by the time you report initial data from the Phase I study?

偉大的。我想，首先，您強調了 SARS-CoV-2 疫苗的 50 微克劑量。我認為福奇博士在採訪中也談到了動物低劑量的良好反應。您能否談談您對能夠繼續前進並用低劑量（而不是您正在測試的其他劑量）引發正確類型的免疫反應的信心？其次，您能否向我們介紹一下該領域的最新情況，並弄清楚中和抗體滴度是多少，以及您是否認為在報告第一階段研究的初始數據時它們將可用？

So this is Tal. Let me take that question. 2 spot-on things that we're looking at. So first of all, 50 microgram is our current best guess. We -- this is short of data and it's based, as you've seen Tony Fauci's remark, on what we expect the platform could deliver. That being said, the final dose selection will really be a factor of, I think, 3 elements. The first is the overall sense of a dose response of how much more do you get as you go up in dose. Because in the case of a pandemic, we obviously need to balance this with having enough doses available. And so you don't want to unnecessarily overshoot. The second element is an understanding of what that dose could mean as you compare to convalescent serum. And so there's a lot of work being done on assay validation, and I'll get back to that in a minute, to understand what any given level of antibodies mean. And the last element that I think will enable us to connect the dots is understanding the performance of the vaccine in additional animal models of SARS-CoV-2 and then seeing, commensurate with the expected ability to protect those animals, what levels of titers do we get. And obviously, the higher the species the more reliable that data is. But ultimately, what we care about is being able to connect the dots for human disease. So it's a -- long story short, it's a best guess estimate for now and based on the emerging data, and we will continue to refine it as more data comes in.

這就是塔爾。讓我來回答這個問題。我們正在關注的 2 個恰到好處的事情。首先，50 微克是我們目前最好的猜測。我們——這缺乏數據，正如你所看到的托尼·福奇的評論，它是基於我們期望該平台能夠提供的東西。話雖這麼說，我認為最終的劑量選擇實際上取決於三個因素。第一個是劑量反應的整體感覺，即隨著劑量的增加，你會得到多少。因為在大流行的情況下，我們顯然需要在這一點與提供足夠的劑量之間取得平衡。所以你不想不必要地過度調整。第二個要素是了解與恢復期血清相比該劑量可能意味著什麼。因此，在檢測驗證方面正在進行大量工作，我將在一分鐘內回到這一點，以了解任何給定水平的抗體的含義。我認為使我們能夠將這些點聯繫起來的最後一個要素是了解疫苗在其他 SARS-CoV-2 動物模型中的表現，然後根據保護這些動物的預期能力，了解滴度水平是多少我們得到了。顯然，物種越高，數據就越可靠。但最終，我們關心的是能夠將人類疾病的各個點聯繫起來。所以這是一個——長話短說，這是目前基於新出現的數據的最佳猜測估計，隨著更多數據的到來，我們將繼續完善它。

Your question about the right kind of immune response. Look, I think the data we've seen to date, both across the clinical trials, across the experience that we have in the preclinical models, across the board, as I mentioned, in all the other clinical trials, we've routinely reported neutralizing antibodies as the measure of immunological success. And if you think about the kind of scientific-first principles of how an mRNA technology presents an antigen from within the cell and mimics the instruction set that a virus would otherwise give the cell to make an antigen, we get the right kind of immune response, however we want to characterize it, neutralizing antibody in Th1 versus Th2, et cetera. The emerging data that we're seeing preclinically with mRNA-1273 is all consistent with that.

您關於正確的免疫反應的問題。看，我認為我們迄今為止看到的數據，無論是在臨床試驗中，還是在臨床前模型中的經驗中，正如我提到的，在所有其他臨床試驗中，我們都定期報告中和抗體作為免疫成功的衡量標準。如果你考慮一下 mRNA 技術如何從細胞內呈現抗原並模仿病毒賦予細胞製造抗原的指令集的科學第一原則，我們就會得到正確的免疫反應，但是我們想要表徵它，Th1 與Th2 中的中和抗體，等等。我們在 mRNA-1273 臨床前看到的新數據都與此一致。

Your final question, on neutralizing antibodies, yes, those assays are being stood up as we speak. They're being validated. They're being transferred to commercial vendors. And the NIAID is actively looking at in parallel with the simpler types of binding antibodies we expect to be able to report, both kinds of data when we see the data from that Phase I.

你的最後一個問題是關於中和抗體，是的，就在我們說話的時候，這些檢測已經被證實了。它們正在被驗證。它們正在被轉移給商業供應商。當我們看到第一階段的數據時，NIAID 正在積極研究與我們期望能夠報告的更簡單類型的結合抗體並行的數據。

Your next question comes from Cory Kasimov of JPMorgan.

你的下一個問題來自摩根大通的科里·卡西莫夫。

I've got 2 of them for you as well. So I guess, first, can you talk more about what the Phase III COVID vaccine design might look like? And there's, obviously, nothing traditional about this program. So how should we be thinking about kind of like the endpoints interim analysis and amount of follow-up you think you need for either emergency use authorization or full approval? And then my second question for you is regarding COVID -- also regarding COVID-19. There have been some conflicting reports out there on emerging mutations with the virus. I'd be very interested to hear your views on this and what it could potentially mean for the effectiveness of your vaccine.

我也給你準備了 2 個。所以我想，首先，你能更多地談談第三階段的新冠疫苗設計可能是什麼樣子嗎？顯然，這個項目沒有任何傳統之處。那麼，我們應該如何考慮端點臨時分析和您認為緊急使用授權或完全批准所需的後續工作量？我要問你的第二個問題是關於新冠肺炎 (COVID-19) 的。關於該病毒正在出現的突變，存在一些相互矛盾的報導。我很想听聽您對此的看法以及它對您的疫苗有效性可能意味著什麼。

Thanks, Cory. This is Tal. I'll take those questions. So look, the Phase III design, let me make a couple of points. Any pivotal trial in order to demonstrate efficacy as well as safety has to be placebo-controlled and large enough so that the people -- among the people that you will vaccinate, there will by chance occur cases, right? And so it's a case-driven design and you set your statistics based on what you expect to see and how many cases you expect to see in the placebo and then how many fewer cases do you expect the vaccine to demonstrate. Now any such trial to be effective depends on 3 things: how big it is when you start, how good are you at predicting the attack rate in the population that you vaccinated, because if it's case-driven design, then we can vaccinate a whole lot of people. But if they end up for the months to come not being exposed to the risk of an infection, then we won't know whether the vaccine work. And the third element is how good our vaccine is, because the higher the point estimate for the vaccine efficacy, the clear the results are and the sooner you can find them.

謝謝，科里。這是塔爾。我會回答這些問題。所以看，第三階段的設計，讓我說幾點。為了證明有效性和安全性，任何關鍵試驗都必須以安慰劑為對照，並且規模足夠大，以便在您將要接種疫苗的人群中，偶然會出現病例，對嗎？因此，這是一種病例驅動的設計，您可以根據您期望看到的內容以及您期望在安慰劑中看到的病例數以及您期望疫苗顯示的病例數減少多少來設置統計數據。現在，任何此類試驗的有效性取決於三件事：開始時規模有多大，您在預測接種疫苗的人群中的發病率方面有多好，因為如果是病例驅動設計，那麼我們可以為整個人群接種疫苗很多人。但如果他們最終在未來幾個月內沒有暴露於感染的風險，那麼我們將不知道疫苗是否有效。第三個要素是我們的疫苗有多好，因為疫苗功效的點估計越高，結果就越明確，你就能越早找到它們。

Somewhere between those parameters, we are going to have to have a conversation. It's ongoing between us, our collaborators at NIAID, at the NIH, and ultimately, FDA. The length of follow-up here and how soon can we see the data, I think, is a function of all those design elements as well as where you sort of set the bar for cases and what expected benefit is. Now you asked an interesting question on where does EUA come into this, where does approval, and what kind of interim data one could expect. So I think if -- as you get closer to it, my sense is that we're not looking at a binary event in the sense that, one day, we know nothing, and the next day, it's suddenly available for everybody. I think as we learn more about the potential benefit first based on Phase I and II and potentially surrogate data in animal models, and an understanding what those levels could mean from convalesce interim, we will gain more confidence as to the potential benefit of this vaccine.

在這些參數之間的某個地方，我們必須進行對話。我們、NIAID、NIH 以及最終 FDA 的合作者之間正在進行這一工作。我認為，這裡的後續時間長度以及我們多久可以看到數據是所有這些設計元素以及您為案例設置標準和預期收益的函數。現在，您提出了一個有趣的問題，即 EUA 在哪裡介入、在哪裡獲得批准以及可以期待什麼樣的臨時數據。所以我認為，當你越來越接近它時，我的感覺是，我們並不是在考慮一個二元事件，即有一天，我們一無所知，而第二天，每個人都可以突然獲得它。我認為，隨著我們首先根據第一階段和第二階段以及動物模型中的潛在替代數據了解更多潛在益處，並了解這些水平在恢復期期間可能意味著什麼，我們將對這種疫苗的潛在益處更有信心。

We will still not be talking about an approval. We will not have a full safety database. But you start to generate an anticipation of potential benefit. In the context of a ranging pandemic, I think that's important.

我們仍然不會談論批准。我們不會有完整的安全數據庫。但你開始產生對潛在利益的預期。在大流行的背景下，我認為這一點很重要。

The next step of data is then to get a sense that the vaccine is safe when given to a larger group of individuals, both healthy people, people with -- who are older with comorbidities. And we need to go and build that safety database in the appropriate placebo-controlled I mentioned. And the final piece is then to actually demonstrate clinical utility benefit, and that requires to have an endpoint that's meaningful.

數據的下一步是了解疫苗在給更大的人群（包括健康人群和患有合併症的老年人）注射時是安全的。我們需要在我提到的適當的安慰劑對照中建立安全數據庫。最後一部分是實際證明臨床效用益處，這需要有一個有意義的終點。

And I think the 2 endpoints that are relevant for thinking about a pivotal trial are going to be COVID-19 disease. So however you define a disease, the appropriate symptomatology, severity and having a microbiological confirmation.

我認為與考慮關鍵試驗相關的 2 個終點將是 COVID-19 疾病。因此，無論您如何定義疾病，都需要適當的症狀、嚴重程度以及微生物學確認。

And of course, infection per se is also a relevant endpoint because we know that asymptomatic people, even if they themselves are asymptomatic, if you can prevent infection, you will, on a population basis, actually prevent others from getting infected and then being fixed. So there's a benefit to society here of preventing infection even if less so to the individual vaccinee.

當然，感染本身也是一個相關的終點，因為我們知道，無症狀的人，即使他們本身沒有症狀，如果你能預防感染，那麼在人口基礎上，你實際上可以防止其他人被感染，然後被治愈。因此，預防感染對社會是有好處的，即使對個體疫苗接種者的好處較小。

So between the disease endpoint and infection endpoint, I think that's where you're going to see the pivotal trials in the space emerge. I hope that answers your question on the design. As we get closer to it, we lock it down with the NIH and the FDA, we will, of course, be describing it in public.

因此，在疾病終點和感染終點之間，我認為這就是該領域關鍵試驗出現的地方。我希望這能回答您有關設計的問題。當我們越來越接近它時，我們會向 NIH 和 FDA 鎖定它，當然，我們會公開描述它。

Your question regarding the emerging mutations. We're all following that closely. I will make 2 points here.

你關於新出現的突變的問題。我們都在密切關注這一點。我在這裡提出2點。

Number one, so far from what we've seen, none of the mutations that have been described are expected to significantly interfere with binding or neutralizing activities of antibodies generated to the full-length spike protein. And here, I would make the -- I'd remind you that our mRNA-1273 actually encodes for the full-length spike protein.

第一，到目前為止，從我們所看到的情況來看，所描述的突變都不會顯著干擾全長刺突蛋白產生的抗體的結合或中和活性。在這裡，我要提醒您，我們的 mRNA-1273 實際上編碼全長刺突蛋白。

I think the mutation that everybody kind of saw last week had to do with potentially increased submissibility but that mutation doesn't necessarily alter the critical neutralizing binding domains as we understand them. So we're clearly watching this area closely like everybody else to assess the potential impact.

我認為上週每個人都看到的突變與潛在增加的順服性有關，但這種突變並不一定會改變我們所理解的關鍵中和結合域。因此，我們顯然像其他人一樣密切關注這一領域，以評估潛在影響。

The second point, I'd say, sort of with a more longer-term vision. Should such a mutation arise and be relevant for the immunity of the population that's been exposed or the effectiveness of any vaccine, I would contend that, actually, our platform is going to be uniquely suited to address that for 2 reasons.

我想說，第二點具有更長遠的願景。如果出現這種突變，並且與暴露人群的免疫力或任何疫苗的有效性相關，我認為，實際上，我們的平台將特別適合解決這個問題，原因有兩個。

Number one is, as we've demonstrated, you can move very fast based on just understanding the sequence of a new mutation and you immediately generate a vaccine against it. But importantly, as you look to the future, one could envision a world where if we've demonstrated efficacy and benefit against this virus in the appropriate randomized-controlled trials, if there's a slight mutation and you alter the vaccine to kind of chase the virus, the path to approval and expected benefit for the next one should be much quicker. And you can think of the way the world has evolved to deal with flu mutations, whereby as soon as there's a new sequence, that sequence is actually put into production and millions of doses of vaccines are generated. You don't need to replicate the entire Phase I, II, III development path every time there's a minor mutation once you've established the platform.

第一，正如我們已經證明的那樣，您只需了解新突變的序列就可以非常快速地採取行動，並立即生成針對該突變的疫苗。但重要的是，當你展望未來時，人們可以想像這樣一個世界：如果我們在適當的隨機對照試驗中證明了對這種病毒的功效和益處，如果有輕微的突變，並且你改變了疫苗以追趕這種病毒病毒，下一個的批准路徑和預期收益應該要快得多。你可以想像世界是如何進化來應對流感突變的，只要有一個新的序列，該序列就會實際投入生產，並生產出數百萬劑疫苗。一旦你建立了平台，你不需要每次出現微小的變​​化時都複製整個第一、第二、第三階段的開發路徑。

So as I look to the future, I think we're in a very good place from the fundamentals of our platform to envision that sort of response to any rising mutations.

因此，當我展望未來時，我認為從我們平台的基本原理來看，我們處於一個非常好的位置，可以設想對任何上升的突變做出這種反應。

(Operator Instructions) Your next question comes from Ted Tenthoff, Piper.

（操作員說明）您的下一個問題來自 Piper 的 Ted Tenthoff。

Ted, you might be on mute.

特德，你可能處於靜音狀態。

Your next question comes from Salveen Richter of Goldman Sachs.

你的下一個問題來自高盛的 Salveen Richter。

Where you're looking at challenging animal models and then examining the antibody levels in humans?

您在哪裡尋找具有挑戰性的動物模型，然後檢查人類的抗體水平？

And then a second question around with regard to supply and demand constraints, is the Lonza partnership really just kind of where you -- I guess is that -- are you going to expand beyond that to kind of handle demand and supply?

然後是關於供應和需求限制的第二個問題，龍沙合作夥伴關係真的只是你——我想是這樣——你會超越這一點來處理需求和供應嗎？

This is Tal. Let me try and take your first question. I think you got cut off, but if I understood you correctly, you asked whether we're running animal channel challenge models and whether we will be able to connect the dots between those and what we see in human vaccinees.

這是塔爾。讓我嘗試回答你的第一個問題。我想你被打斷了，但如果我理解正確的話，你問我們是否正在運行動物通道挑戰模型，以及我們是否能夠將這些模型與我們在人類疫苗接種者中看到的模型聯繫起來。

And I think the answer is, yes. That work is ongoing. It's been done in close collaboration with Barney Graham's team at the VRC of the NIH. And the assay development work that is ongoing is being deployed, so that we are able to connect the dots between the challenge models, convalescent serum and the serum that we eventually expect to see from people who have been vaccinated.

我認為答案是肯定的。這項工作正在進行中。這是與 NIH VRC 的 Barney Graham 團隊密切合作完成的。正在進行的檢測開發工作正在部署中，以便我們能夠將挑戰模型、恢復期血清和我們最終期望從接種疫苗的人身上看到的血清之間的點聯繫起來。

So I hope that answers that question, Salveen. Let me turn it over to Juan to talk about or Stéphane to talk about the Lonza question.

所以我希望這能回答這個問題，Salveen。讓我把它交給胡安來談談，或者讓史蒂芬來談談龍沙問題。

This is Juan Andres, Chief Clinical Operations and Quality Officer in Moderna. So let me take the second question that you have.

我是 Juan Andres，Moderna 首席臨床運營和質量官。那麼讓我回答你的第二個問題。

Lonza brings an incredible track record in supporting and manufacturing products worldwide. Lonza's capacity, together with the capacity that we have in our site in Massachusetts and the capability, will be a great help for Moderna scaling up and also producing the quantities. We are going to manufacture together with Lonza the formulated bulk, and I expect that we will have more partnership with existing CMOs once we're finished in distribution, and if needed, with new ones. Thank you.

龍沙在全球支持和製造產品方面擁有令人難以置信的記錄。 Lonza 的產能，加上我們在馬薩諸塞州工廠的產能和能力，將為 Moderna 擴大規模和生產數量提供巨大幫助。我們將與 Lonza 一起生產配方散裝產品，我希望一旦我們完成分銷，我們將與現有的 CMO 建立更多的合作夥伴關係，如果需要，我們將與新的 CMO 建立更多的合作關係。謝謝。

Your next question comes from Ted Tenthoff with Piper.

您的下一個問題來自 Ted Tenthoff 和 Piper。

Great. Can you hear me okay?

偉大的。你能聽到我說話嗎？

Yes.

是的。

Great. Sorry about that before. And thank you for all of the hard work. It's been just an incredible run during this last couple of weeks and the company has really risen to the challenges. Lorence, it's been so nice working with you, and I'm wishing you all the best too.

偉大的。之前就很抱歉了。感謝大家的辛勤工作。過去幾週的運行令人難以置信，該公司確實已經迎接了挑戰。洛倫斯，與你合作真是太好了，我也祝你一切順利。

So my question actually has to do with CMV. And I know you guys have talked about sort of the challenges just with getting the final data sets and the final process and all those things. So I wanted to see if there's an update on that and whether or not there's any changes to the expectation for data in the third quarter. And also, how this general progress and investment in the vaccine platform will really help what you're doing in CMV.

所以我的問題實際上與 CMV 有關。我知道你們已經談到了獲取最終數據集和最終流程以及所有這些事情所面臨的挑戰。所以我想看看是否有更新，以及第三季度數據的預期是否有任何變化。此外，疫苗平台的總體進展和投資將如何真正幫助您在 CMV 領域所做的工作。

Thanks, Ted, for the kind words. This is Tal. Let me try and take maybe both of those questions, and Stéphane can add on.

謝謝特德的客氣話。這是塔爾。讓我嘗試回答這兩個問題，Stéphane 可以補充一下。

On CMV, I believe we remain on track, and it's -- you can do the simple math here. If we've already vaccinated over 70% of people with the second dose, and it's that critical post second dose interim analysis, that should confirm our dose for Phase III. If you recall the data from the Phase I, with much smaller numbers of subjects, we had pretty tight error bars and a pretty good understanding of the dose response curve.

在 CMV 上，我相信我們仍然走在正軌上，你可以在這裡做簡單的數學計算。如果我們已經為超過 70% 的人接種了第二劑疫苗，並且這是第二劑疫苗後關鍵的中期分析，那麼應該可以確認我們的 III 期疫苗劑量。如果你回想一下第一階段的數據，受試者數量要少得多，我們有非常嚴格的誤差線，並且對劑量反應曲線有很好的理解。

Now with the much larger study, even if it ran into some sort of difficulty because of COVID-19, we're going to be more than powered to understand the immunogenicity. And the size was really driven not just by the need to understand immunogenicity, but also to validate the safety profile that we see here. So I'm confident that with the numbers of people that we managed to get into the second dose, the amendment of the protocol, as mentioned for the remaining less than 30%, that we will stay on track, as we've discussed before, to have the data and be able to move on. And our plans for Phase III continue and remain fully on track for CMV.

現在，隨著研究規模的擴大，即使由於 COVID-19 而遇到某種困難，我們也將有能力了解免疫原性。其大小實際上不僅是由了解免疫原性的需要決定的，也是為了驗證我們在這裡看到的安全性。因此，我相信，隨著我們設法進入第二劑疫苗的人數，以及針對剩餘不到 30% 的方案的修訂方案，我們將保持在正軌上，正如我們之前討論過的那樣，獲得數據並能夠繼續前進。我們的 CMV 第三階段計劃仍在繼續，並完全步入正軌。

Your question on how it's preparing the platform. I'll give you sort of a brief answer from approach of maybe medical and development, and then I'll let Stéphane talk as it relates to the company becoming sort of moving to its commercial life phase.

您關於如何準備平台的問題。我將從醫療和開發方面給您一個簡短的回答，然後我將讓 Stéphane 談談這與公司進入商業生命階段有關。

The COVID experience is doing really 3 things for us. It is accelerating our understanding of the safety and immunogenicity at a much wider level for the platform, sort of the leading edge of data, if you will. And I expect that the ability to run a large placebo-controlled trial and expand the safety database at a much more rapid manner than we had so far in Phase I will be informative for all of us as to the performance of this platform. And here, I sort of speak as a Chief Medical Officer with a keen eye on the safety profile of our platform. So far, we've seen nothing unexpected and it's all been sort of consistent across the application. But of course, a database of 1,500 subjects will benefit greatly when we go into thousands with COVID.

新冠疫情的經歷確實為我們做了三件事。它正在加速我們在更廣泛的層面上對該平台的安全性和免疫原性的理解，如果你願意的話，可以說是數據的前沿。我預計，運行大型安慰劑對照試驗並以比第一階段迄今為止更快的速度擴展安全數據庫的能力將為我們所有人提供有關該平台性能的信息。在這裡，我以首席醫療官的身份發言，對我們平台的安全狀況有著敏銳的關注。到目前為止，我們還沒有看到任何意外情況，並且整個應用程序中的一切都是一致的。當然，當我們涉及數千名新冠患者時，包含 1,500 名受試者的數據庫將受益匪淺。

The second element has to do with expanding our capabilities, building up a development team that can integrate and build a BLA file, building up our competencies on the regulatory front, the pharmacovigilance front, et cetera. All of that ahead of a large Phase III effort on CMV, I think, is a tremendous benefit for us.

第二個要素與擴展我們的能力、建立一個可以集成和構建 BLA 文件的開發團隊、增強我們在監管方面、藥物警戒方面等方面的能力有關。我認為，在 CMV 第三階段的大規模努力之前，所有這些對我們來說都是巨大的好處。

And I'll sort of -- I'll let Stéphane speak to all the other elements where this is accelerating the progress of our company.

我會讓 Stéphane 談談這加速我們公司進步的所有其他因素。

Thanks, Tal. I would just add a few things. And I think Tal started to allude to it, which is the power of our platform, which really create some very powerful network effects, where -- if you take an example of something new we shared today, which is we had a positive Type C meeting last quarter around CMV for CMNC support manufacturing.

謝謝，塔爾。我只想添加一些內容。我認為 Tal 開始提到這一點，這是我們平台的力量，它確實創造了一些非常強大的網絡效應，如果你舉一個我們今天分享的新東西的例子，那就是我們有一個積極的 Type C上季度圍繞CMV 召開會議，以支持CMNC 製造。

As you can appreciate, this dialogue with the agency around CMV Phase III is going to be very instrumental in helping us on the Phase III for SARS CoV-2 mRNA-1273. Because of the urgency that the agency has, we've had an amazing dialogue with the FDA. The responsiveness, 7 days a week, very engaged, very willing to find every way to shape a deal process without making any shortcut on safety, obviously.

正如您所理解的，與該機構圍繞 CMV III 期的對話將非常有助於幫助我們進行 SARS CoV-2 mRNA-1273 的 III 期研究。由於該機構的緊迫性，我們與 FDA 進行了一次精彩的對話。顯然，每週 7 天的響應能力，非常投入，非常願意尋找各種方法來塑造交易流程，而不會在安全方面走任何捷徑。

So for this BLA process, that we should be able to go through in the next months, both on the clinical side and also on the manufacturing side. This access to the agency, with this ability to ask question, to get clarification quickly will really help us really build that capability within the team, but also all the digital infrastructure in terms of data gathering, which is critical, both on clinical and on CMC. Then you're going to be able to use that very quickly on Zika, on CMV. And I think that's going to be very powerful.

因此，對於這個 BLA 流程，我們應該能夠在接下來的幾個月內完成，無論是在臨床方面還是在製造方面。這種與該機構的聯繫，具有提出問題、快速獲得澄清的能力，將真正幫助我們在團隊內真正建立這種能力，而且也有助於我們在數據收集方面建立所有數字基礎設施，這對於臨床和臨床都至關重要。中央軍事委員會。然後你將能夠非常快速地在寨卡病毒、CMV 上使用它。我認為這將非常強大。

The network effect, I think are sometime underappreciated because most companies, as you know, do not have platforms, whereas here, because mRNA being information molecule, there's really an ability to make Moderna very robust and to take it to the next level. So that's what we do on SARS CoV-2 BLA-wise can be replicated much faster and much stronger on Zika, CMV and all the other programs.

我認為網絡效應有時會被低估，因為正如你所知，大多數公司沒有平台，而在這裡，因為mRNA 是信息分子，所以確實有能力使Moderna 變得非常強大，並將其提升到一個新的水平。這就是我們在 SARS CoV-2 上所做的事情，BLA 可以在 Zika、CMV 和所有其他項目上更快、更強大地複制。

I think it'll be the same things around commercial. With the arrival of Patrick, we are going to build very rapidly in our commercial infrastructure. We'll give you updates on that in the coming months. But as you can appreciate, all that work that's going to happen very quickly on COVID will help us on the other products. But totally as a competitive branding standpoint because, as you appreciate, the Moderna brand has been transformed in the last few months because of the results that the team has been able to accomplish. First of all, the product at center of advancement at the clinical level. So I think the momentum of Moderna is going to be extremely strong and extremely enabled by the SARS CoV-2 verifying process.

我認為商業領域也會有同樣的情況。隨著帕特里克的到來，我們將非常迅速地建設我們的商業基礎設施。我們將在未來幾個月內向您提供相關最新信息。但正如您所理解的，所有針對新冠病毒的工作很快就會發生，這將有助於我們開發其他產品。但完全是從一個有競爭力的品牌角度來看，因為正如你所理解的，由於團隊能夠取得的成果，Moderna 品牌在過去幾個月裡已經發生了轉變。首先，該產品處於臨床水平的進步中心。因此，我認為 Moderna 的勢頭將非常強勁，並且受到 SARS CoV-2 驗證過程的極大推動。

(Operator Instructions) Your next question comes from Yasmeen Rahimi at ROTH Capital Partners.

（操作員說明）您的下一個問題來自 ROTH Capital Partners 的 Yasmeen Rahimi。

Thank you for the continued amazing progress that you're making day over day. Two quick questions for you.

感謝您日復一日不斷取得的驚人進步。有兩個簡單的問題要問你。

The first question is related to how are you defining age cut-off? In the Phase II, you mentioned there will be a cohort of patients who are 55 and above. Is there maybe a range above which you're not going to be going after? And then is there going to be a cohort among the Phase II and as you're thinking about Phase III that are healthy but are at highest risk given that maybe they have obesity or cardiovascular disease? How are we thinking about this patient population that are at the highest risk to incorporate that into the Phase II and Phase III enrollment?

第一個問題與您如何定義年齡截止有關？在第二階段，你提到會有一群55歲及以上的患者。是否存在一個您不會追求的範圍？那麼，在第二階段和第三階段中，是否會有一群人是健康的，但考慮到他們可能患有肥胖或心血管疾病，他們的風險最高？我們如何考慮將這些風險最高的患者群體納入 II 期和 III 期招募？

And then the second question is in regards to manufacturing. If you could help us understand, what is the single largest unknown when it comes to scaling up mRNA therapeutics?

第二個問題是關於製造的。如果您能幫助我們了解，在擴大 mRNA 療法方面最大的未知數是什麼？

This is Tal. Let me start by answering the clinical ones, and then I'll let Juan take the manufacturing question. The -- in our Phase II, there is no upper limits. I think above 55. You've seen the NIH Phase I sort of parse it out a little bit more finely. I think, for us, we're going to take all comers above 55 with no upper age limit.

這是塔爾。讓我首先回答臨床問題，然後讓胡安回答製造問題。在我們的第二階段，沒有上限。我認為高於 55。您已經看到 NIH 第一階段對其進行了更精細的解析。我認為，對我們來說，我們將接納 55 歲以上的所有參與者，沒有年齡上限。

In terms of your question on cohorts at higher risk for disease should they get infected, this relates to both the elderly and people with distinct comorbidities. As we build the safety database, obviously, we need to get there, but get there responsibly. I think the Phase II, the initial sort of expansion into larger numbers is people that do not have a high-risk of disease should they get infected. In the Phase III, we will clearly then open it up, and we will do that in a manner that's responsible and takes the appropriate interim looks to make sure that we expand into that population who needs it the most in a way that's careful. And that's an ongoing discussion, obviously, between us, NIAID and FDA how to best achieve that goal.

就您關於如果被感染的話疾病風險較高的人群的問題而言，這與老年人和患有明顯合併症的人有關。顯然，當我們建立安全數據庫時，我們需要到達那裡，但要負責任地到達那裡。我認為第二階段，最初的擴大規模是那些被感染後患病風險不高的人。在第三階段，我們將明確地開放它，我們將以負責任的方式做到這一點，並採取適當的臨時措施，以確保我們以謹慎的方式擴展到最需要它的人群。顯然，我們、NIAID 和 FDA 之間一直在討論如何最好地實現這一目標。

Let me let Juan take your manufacturing question.

讓我讓胡安回答你的製造問題。

Okay. Thanks. Thanks for the question. Obviously, one of the unknowns we discussed before which is the assumptions associated with dose. And then in terms of the industrialization of the product, obviously, where we're working very hard is in bringing the equipment, bringing the raw materials, bringing the people capabilities together as we scale up.

好的。謝謝。謝謝你的提問。顯然，我們之前討論的未知數之一是與劑量相關的假設。然後就產品的工業化而言，顯然，我們非常努力的地方是隨著我們規模的擴大，帶來設備、原材料、人員能力。

I don't think it is a very single unknown in dose. We have done this before, probably not at the scale at which we are going. Having the partnership with Lonza gives me a tremendous confidence that we are going to be doing this very rapidly. And obviously, speed is of the essence. Bringing these 3 things together is what it's all about, and that's what we are doing.

我不認為這是一個非常單一的劑量未知數。我們以前曾這樣做過，但可能沒有達到我們現在的規模。與 Lonza 的合作給了我極大的信心，我們將非常迅速地做到這一點。顯然，速度至關重要。將這三件事結合在一起就是一切，這就是我們正在做的事情。

Yes. And maybe Yasmeen, just to add something. We are extremely fortunate to have Juan and this leadership team. As you know, he and the team have all come from large organization. They have managed a very large manufacturing complex organization. They have a lot of experience. They know that every extra million dose we can get out of our system will be helping a lot of people.

是的。也許還有亞斯明，只是補充一些東西。我們非常幸運有胡安和這個領導團隊。如您所知，他和團隊都來自大型組織。他們管理著一個非常大的製造綜合組織。他們有很多經驗。他們知道，我們從系統中獲得的每一百萬劑量都將幫助很多人。

So I'm very thankful for the team. They are literally working 7 days a week, pulling all-nighters to shave every day we can so that we can really maximize the [mostly] output of the system, and I'm tremendously thankful for them.

所以我非常感謝團隊。他們實際上每週工作 7 天，每天都通宵達旦地刮鬍子，這樣我們才能真正最大限度地提高系統的[大部分]輸出，我非常感謝他們。

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

您的下一個問題來自美國銀行的傑夫·米查姆 (Geoff Meacham)。

This is Alec on for Jeff. And Lorence, we're sorry to see you go, but I assume you're moving on to bigger and better things.

這是亞歷克替傑夫發言。洛倫斯，我們很遺憾你離開，但我想你會繼續做更大、更好的事情。

So my question is on capital allocation in the near term. You reiterated your 2020 expense guidance. But I was hoping you could give a bit more color on the gives and takes within that vis-a-vis OpEx versus CapEx. And how much manufacturing build-out and commercial readiness activities for COVID-19 are reflected within that?

所以我的問題是關於近期的資本配置。您重申了 2020 年費用指導。但我希望您能夠對運營支出與資本支出的給予和索取提供更多的說明。其中反映了多少針對 COVID-19 的製造業擴建和商業準備活動？

And my second question is on the commercialization front. Do you intend to take the vaccine forward yourselves? Or do you think it will take partnering to deliver that at scale? Or would the U.S. government potentially step in as well? Any color you can give here. And if there's some historical context you could point to, that would be great.

我的第二個問題是關於商業化方面的。您打算自己推進疫苗研發嗎？或者您認為需要合作才能大規模實現這一目標？或者美國政府也可能介入嗎？您可以在這裡提供任何顏色。如果您可以指出一些歷史背景，那就太好了。

Alec, it's Lorence. Let me handle the financial question. With respect to the guidance and the components, so as I mentioned around sort of the pre-COVID business, if you will, I'd mentioned that we're seeing a bit of a slowdown in expenses, OpEx related to lab work and some of the clinical trials, as we've noted. And so those expenses will be coming down relative to what we thought when we originally set out guidance.

亞歷克，我是洛倫斯。讓我來處理財務問題。關於指南和組成部分，正如我提到的關於新冠疫情前的業務，如果你願意的話，我提到我們看到支出、與實驗室工作相關的運營支出和一些支出有所放緩。正如我們所指出的，臨床試驗的結果。因此，這些費用將相對於我們最初制定指導時的想法有所下降。

The offset is investments that we are making to be ready for all that's coming down the road. We've mentioned this -- the rapid acceleration of the COVID vaccine timelines, and there's a lot that we need to do at the company to be ready for potentially being commercial in 2021. And so those offset, we will continue to update you all as we -- as we scope those investments as we move forward.

抵消額是我們為應對即將發生的一切而進行的投資。我們已經提到過這一點——新冠疫苗時間表的迅速加快，我們公司需要做很多事情，為 2021 年的商業化做好準備。因此，我們將繼續向大家通報最新情況當我們在前進的過程中確定這些投資的範圍時。

With respect to CapEx, it is not a huge component here right now of the anticipated budget, mainly because of the leverage we've got in the platform as well as the benefit of having a great partner like Lonza on board. And again, we'll continue to update that guidance should anything change.

就資本支出而言，目前它並不是預期預算的重要組成部分，主要是因為我們在平台中擁有的槓桿作用以及擁有像 Lonza 這樣的優秀合作夥伴的好處。再次強調，如果有任何變化，我們將繼續更新該指南。

And then the last thing I would just reiterate is that there is substantial OpEx expected with respect to the COVID vaccine work being funded by BARDA, the clinical development at scale-up. But that will be paid for by BARDA reimbursed on a very rapid cycle time. And so that's why I mentioned that there would be this matching of expense and reimbursement through the course of the year that would substantially offset.

我要重申的最後一件事是，BARDA 資助的新冠疫苗工作（擴大臨床開發）預計會有大量運營支出。但這將由 BARDA 支付，並以非常快的周期報銷。這就是為什麼我提到，在這一年中，費用和報銷的匹配將大大抵消。

Yes. Thanks, Lorence. And Alec, on commercialization, as you can appreciate, as we've said before, with the case of CMV, we do not anticipate having the capability and investing to sell the products in [our complete] countries.

是的。謝謝，洛倫斯。 Alec，關於商業化，正如您所理解的，正如我們之前所說，就 CMV 而言，我們預計沒有能力和投資在[我們所有的]國家/地區銷售產品。

For SARS CoV-2, I think it's important to think about the product in 2 different time horizon. There is a pandemic phase, in which obviously, we all are. And then we believe, as a company, there's some opportunity for this product in the pandemic phase because we do not believe this virus is going away.

對於 SARS CoV-2，我認為在兩個不同的時間範圍內考慮該產品很重要。現在有一個大流行階段，顯然我們都處於這個階段。然後我們相信，作為一家公司，該產品在大流行階段有一些機會，因為我們不相信這種病毒會消失。

So for the pandemic phase, it's going to be mostly a partnership with governments. So in that case, you don't have to necessarily manage complex sets of potential buyers, because we're going to be, as we discussed, at the global level across the industry, we're going to be supply constrained for some time, which is why, as we've said publicly many times, we are working for everybody with -- working on the vaccine. We are hoping that many vaccines are going to be finished. And because if you think about it, there are actually very few companies that have both the manufacturing scale that is required for the task ahead and are already in the clinic, meaning they can have a short to midterm impact with our vaccine. In my opinion, there are just a couple of companies that have those 2 things.

因此，在大流行階段，主要是與政府合作。因此，在這種情況下，您不必管理複雜的潛在買家，因為正如我們所討論的，我們將在整個行業的全球層面上，我們將在一段時間內受到供應限制，這就是為什麼，正如我們多次公開說過的，我們正在為每個人努力——研究疫苗。我們希望許多疫苗能夠完成。因為如果你仔細想想，實際上很少有公司既具備未來任務所需的生產規模，又已經進入臨床階段，這意味著他們可以對我們的疫苗產生短期到中期的影響。在我看來，只有少數公司具備這兩點。

And so if you think about it in a very supply-constrained world in 2021, it's going to be mostly partnering with governments. So that they will do the allocation in the different geographies. We do not intend, for example, in the U.S. to decide who gets the vaccine. That will not be appropriate. So we intend to continue our partnership with the U.S. government, that we've already done with NIAID. And Dr. Tony Fauci's team for a few years, as you know. And in the clinic more recently, with BARDA, and eventually, I assume the CDC, to be able to supply to the U.S. government the doses, for them to decide the allocation that makes sense for the country.

因此，如果你在 2021 年供應非常有限的世界中思考，你會發現，這將主要是與政府合作。這樣他們就會在不同的地區進行分配。例如，我們不打算在美國決定誰接種疫苗。那是不合適的。因此，我們打算繼續與美國政府建立夥伴關係，就像我們已經與 NIAID 建立的伙伴關係一樣。如您所知，托尼·福奇博士的團隊已經工作了幾年。最近在診所，我認為與 BARDA 以及最終的 CDC 一起，能夠向美國政府提供劑量，讓他們決定對國家有意義的分配。

Your next question comes from Alan Carr of Needham & Company.

您的下一個問題來自 Needham & Company 的艾倫·卡爾 (Alan Carr)。

Congratulations. I got a couple of them, in your increased focus and success with vaccines, are you able to accelerate? What sort of extra emphasis are you putting on these early-stage vaccine programs? Can you give us an update on 1345 and 1189, your RSV and EBV programs that are internal? How are those moving along? I know you don't give high res info and timelines, but to the extent you can.

恭喜。我有幾個，在你們對疫苗的日益關注和成功中，你們能夠加速嗎？您對這些早期疫苗計劃有何額外重視？您能給我們介紹一下你們內部 RSV 和 EBV 計劃 1345 和 1189 的最新情況嗎？那些進展如何？我知道您不會提供高分辨率信息和時間表，但在您可以的範圍內。

Then the other question is around your COVID-19 program. To what extent is it feasible to have even an interim analysis of your the planned Phase III trial in 2020?

另一個問題是關於您的 COVID-19 計劃。對計劃於 2020 年進行的 III 期試驗進行中期分析在多大程度上可行？

So let me start maybe with your first question, on EBV and RSV pediatric. As you know, we do not guide on programs' timelines. So the team is working on advancing those important vaccines as fast as possible. But we have given no timelines, and we will not give timelines. On the retail, as you appreciated over the quarters, to give timelines, when we get closer to kind of late-stage development and especially with the SARS CoV-2, given the pandemic and given the suffering around the world, we think it's important to communicate our best plans. And I hope everybody can appreciate that when we say we aim to start a Phase III early summer, this is the best possible physical plan. Fifty things can derail that. But for the early programs, we are not communicating.

那麼，讓我從您的第一個問題開始，關於 EBV 和 RSV 兒科。如您所知，我們不對計劃的時間表提供指導。因此，該團隊正在努力盡快開發這些重要的疫苗。但我們沒有給出時間表，我們也不會給出時間表。在零售方面，正如您在幾個季度中所讚賞的那樣，給出時間表，當我們接近後期​​開發時，尤其是SARS CoV-2，考慮到大流行和世界各地的苦難，我們認為這很重要傳達我們的最佳計劃。我希望每個人都能理解，當我們說我們的目標是在初夏啟動第三階段時，這是最好的物理計劃。有五十件事可以破壞這一點。但對於早期的項目，我們並沒有進行交流。

Tal, do you want to take the COVID interim data question?

Tal，您想回答有關新冠肺炎中期數據的問題嗎？

Yes. Yes. Yes. It's a good question. I believe we should be able to have a sense of the cases and a potential early look by the end of the year. But again, that is a function of how soon can we start, how big the trial is and how good are we at immunizing people who are then at risk for cases occurring, because, as I mentioned, it will end up being a case-driven design to be able to analyze it. And we'll share the details on the expectations once we lock down the design with our partners and vet it with the agency.

是的。是的。是的。這是一個好問題。我相信我們應該能夠在今年年底之前對這些案例有所了解並進行潛在的早期研究。但同樣，這取決於我們多久可以開始、試驗規模有多大，以及我們對那些面臨病例發生風險的人進行免疫接種的能力如何，因為，正如我提到的，它最終會成為一個病例——驅動設計能夠對其進行分析。一旦我們與合作夥伴確定了設計並與機構進行了審查，我們將分享期望的細節。

So do you expect it to be just a U.S. trial, or would you go global? And I guess another, I guess, follow-up to this is, to what -- I mean as we talk about the possibility of a larger trial with multiple vaccines, are you contemplating that, too? Or is this -- the trial that you're planning for Phase II just a Moderna versus -- a Moderna candidate versus placebo?

那麼您預計這只是在美國進行試驗，還是會走向全球？我想另一個後續行動是——我的意思是，當我們談論對多種疫苗進行更大規模試驗的可能性時，您也在考慮這一點嗎？或者，您計劃進行的第二階段試驗只是 Moderna 與 Moderna 候選藥物與安慰劑的對比？

Yes. So let me take both questions in turn. This first pivotal trial is going to be a partnership with NIAID with the NIH. So it will be, at this stage, either solo or a predominantly U.S. trial. We're in parallel, looking at opportunities to launch parallel pivotal trials in Europe and globally, because I think, ultimately, the more data we have here, the wiser we will be.

是的。那麼讓我依次回答這兩個問題。第一個關鍵試驗將是 NIAID 與 NIH 的合作夥伴關係。因此，現階段將是單獨試驗或主要在美國進行試驗。我們正在同時尋找在歐洲和全球範圍內啟動並行關鍵試驗的機會，因為我認為，最終，我們在這裡擁有的數據越多，我們就會越明智。

I think -- can you please remind me your second question?

我想——你能提醒我你的第二個問題嗎？

Yes, I think you answered it. I was wondering if you were contemplating a trial -- or the government contemplating a trial.

是的，我想你已經回答了。我想知道你是否正在考慮進行審判，或者政府是否正在考慮進行審判。

All right. Right, the multi-arm trial, yes. Yes, yes, yes. So there's been a lot of talk about that, both on the WHO side as well as the NIH. As you can clearly intuit, it's not front and center in my brain for 2 reasons.

好的。是的，多臂試驗，是的。對對對。因此，世界衛生組織和美國國立衛生研究院都對此進行了很多討論。正如你可以清楚地直覺到的那樣，它不是我大腦的前沿和中心，原因有兩個。

First is, we expect to be the first one out there for a pivotal trial, and so we just have to get on and demonstrate our trial -- our vaccine's potential.

首先，我們希望成為第一個進行關鍵試驗的人，因此我們只需要繼續並展示我們的試驗——我們的疫苗的潛力。

But the second one is more fundamental. I think it is important for the field to use more or less the case where it actually makes sense to run many vaccines in a single trial. It's not like we're lacking for volunteers who would line up to be immunized and understand the benefit of a vaccine. And frankly, the epidemic is so unpredictable in where it shows up, and to what degree and how it comes down, that there is no expectation of a consistency of attack rate over time that would make that add any scientific value.

但第二個更為根本。我認為對於該領域來說，或多或少使用在一次試驗中運行多種疫苗實際上有意義的情況很重要。我們並不缺乏願意排隊接受免疫並了解疫苗好處的志願者。坦率地說，這種流行病的出現地點、程度和下降方式都是不可預測的，因此隨著時間的推移，攻擊率的一致性不會增加任何科學價值。

So for my -- this is a personal opinion here. I question the merits of that design from a scientific and a public health need perspective. I think what's critical here is that for every vaccine candidate, as Stéphane alluded to, we're going to need more than one of them. But it matters less whether there's a few percent difference on the apparent estimate of the point efficacy, what matters is you know it works and you're able to scale it up and make it available to those who need it the most.

所以對於我來說——這是個人觀點。我從科學和公共衛生需求的角度質疑該設計的優點。我認為這裡最重要的是，正如斯特凡提到的那樣，對於每一種候選疫苗，我們都需要不止一種。但點功效的明顯估計是否有百分之幾的差異並不重要，重要的是你知道它有效，並且你能夠擴大規模並將其提供給最需要它的人。

Your next question comes from Gobind Singh of BMO.

您的下一個問題來自 BMO 的 Gobind Singh。

This is Gobind on for George. Two on 1273.

這是戈賓德為喬治做的。 1273 兩點。

The first one would be, can you help us understand if there's any profit share agreements in place? Were there any other parties, including the NIH, around the vaccine? And just how do you guys see the commercial landscape evolving with so many other vaccine candidates in development?

第一個是，您能否幫助我們了解是否存在任何利潤分享協議？包括美國國立衛生研究院在內的其他各方是否也參與了疫苗的開發？你們如何看待商業環境隨著如此多其他候選疫苗的開發而演變？

And then just to follow-up maybe with the NIAID's comments about their preclinical results that they saw. I understand they're probably doing their studies separate from you guys. But maybe you can help us understand what kind of preclinical results you've seen and when might this data be presented. That would be really helpful.

然後只是跟進 NIAID 對他們所看到的臨床前結果的評論。我知道他們可能與你們分開學習。但也許您可以幫助我們了解您所看到的臨床前結果類型以及這些數據何時可以提供。這真的很有幫助。

Yes. So it's Stéphane. I'm going to start and then the team might think of issues I drop. So it is pretty -- as Tal said, there's preclinical work being done, both in the labs and at NIAID, both with Dr. Tony Fauci's team, as soon as they just -- body of data that makes sense, and is complete and holistic, we intend to publish that work. So as soon as it's public, you'll be aware.

是的。所以這是斯蒂芬。我要開始，然後團隊可能會考慮我放棄的問題。所以這很漂亮——正如塔爾所說，托尼·福奇博士的團隊在實驗室和 NIAID 都在進行臨床前工作，一旦他們剛剛獲得有意義、完整且完整的數據體。整體而言，我們打算出版這項工作。所以一旦公開，你就會知道。

In term of the profit share, we have not disclosed previously any arrangement. So I will not comment on this one. And what was your other question?

在利潤分成方面，我們此前並未透露過任何安排。所以我不會評論這一點。你的另一個問題是什麼？

The commercial landscape and how other coronavirus vaccines are in development?

商業前景以及其他冠狀病毒疫苗的開發情況如何？

Yes. Thank you. So on the commercial landscape, as I briefly mentioned a few minutes ago, as you know, I mean there are 100-plus last time I checked on Wikipedia, vaccine candidates being worked on around the world. The thing I think that are important is manufacturing scale and where are those projects in research of the clinic.

是的。謝謝。因此，在商業領域，正如我幾分鐘前簡要提到的，如您所知，我的意思是，我上次在維基百科上查看時，世界各地正在研究 100 多種候選疫苗。我認為重要的是生產規模以及臨床研究中的項目在哪裡。

As I said a few minutes ago, I believe that the project at this stage in research with a group that doesn't have the ability to do tens of millions of doses come off ramping up to hundreds of millions per month. He's not going to be able to have a big dent on this pandemic. And so if you use those 2 as a screen, which is what we do, I think we end up with a very few number of players, that have again a chance in the 2021 timeframe to have an impact on this. Obviously, like always, in drug development, not every candidate is going to get to a finish line. And I could also anticipate that once a few vaccines are in late stage or commercially approved, a lot of the early project might just stop investing because we are deploying capital and talent for something that might have no commercial end.

正如我幾分鐘前所說，我相信現階段與一個沒有能力進行數千萬劑劑量的團隊進行研究的項目會逐漸增加到每月數億劑。他無法對這場流行病產生重大影響。因此，如果你使用這 2 個作為屏幕，這就是我們所做的，我認為我們最終會得到很少數量的玩家，他們在 2021 年的時間範圍內再次有機會對此產生影響。顯然，就像往常一樣，在藥物開發中，並不是每個候選人都能到達終點線。我還可以預計，一旦一些疫苗進入後期階段或獲得商業批准，許多早期項目可能會停止投資，因為我們正在為可能沒有商業目的的東西部署資本和人才。

So I think while there is a lot of people on the stop lane, my sense is very few of them get to the finish line, with manufacturing scale that matters. One or 2 million doses a year is not going to be very, very helpful at the global scale.

因此，我認為雖然停車道上有很多人，但我的感覺是很少有人能到達終點線，而製造規模很重要。每年一到兩百萬劑在全球範圍內不會有太大幫助。

Your next question comes from Justin Kim with Oppenheimer.

您的下一個問題來自賈斯汀·金和奧本海默。

This is -- it's actually Hartaj on for Justin. So one thing first, Lorence, thank you so very much. It was a real pleasure working with you. I look forward to seeing you again sometime in the future. And then secondly, just to Moderna for all the work that you're doing. I think people -- a lot of people really don't understand just the compression of the timelines that you and the government are engaging. It's really, really a thing of beauty, knock on wood.

這實際上是哈塔傑替補賈斯汀。首先，洛倫斯，非常感謝你。和你一起工作真的很愉快。我期待著將來某個時候再次見到您。其次，謹向 Moderna 感謝您所做的所有工作。我認為人們——很多人真的不理解你和政府正在參與的時間表的壓縮。這真的非常非常美麗，敲木頭。

So 2 questions. One is manufacturing and a second on regulatory strategy worldwide. So on manufacturing, if you can just talk a little bit about going from clinical to commercial batches. I know you've talked, it's gone about going from millions, tens of millions to now billion with Lonza. Can you just talk broadly about the timing? When can you go from that clinical? I know you've mentioned that Lonza will start manufacturing first batches in July. And how that maps against the BLA that you'll be starting to file?

所以有2個問題。一是製造業，二是全球監管策略。那麼在製造方面，您可以簡單談談從臨床批次到商業批次的情況。我知道您說過，Lonza 的銷售額從數百萬、數千萬到現在的數十億。您能大致談談時間安排嗎？你什麼時候可以離開那個診所？我知道您提到 Lonza 將於 7 月份開始生產第一批產品。這與您將開始提交的 BLA 有何對應關係？

And then secondly, on regulatory strategy. Japan just approved remdesivir. I guess the EU is going through an approval process, a fast approval process for remdesivir. So how are you thinking of the worldwide approval strategy aside from the United States where I assume you'll file the BLA towards the end of the year?

其次，關於監管策略。日本剛剛批准了瑞德西韋。我猜歐盟正在經歷一個批准程序，一個對瑞德西韋的快速批准程序。那麼，除了美國之外，您如何看待全球批准策略？我假設您將在年底提交 BLA？

So Hartaj, let me maybe start quickly on manufacturing. We have not done and have shared precise output per month. What we've said is that given we're ramping up both Norwood, which we said could do up to 100 million doses per year at the 50-microgram dose, and then the Lonza site. As you can appreciate basically every month this year, every month next year, the output per month is going to increase. And so the team is working as hard as they can because they do understand, trust me, that every extra 100,000 vial we get out of the system, we will protect more people. We will slow down the spread of this virus.

Hartaj，讓我快速開始製造。我們還沒有完成並分享了每月的精確產量。我們所說的是，鑑於我們正在擴大諾伍德工廠的規模，我們說諾伍德工廠每年可以生產 1 億劑 50 微克劑量的疫苗，然後是 Lonza 工廠。正如你可以看到的那樣，今年基本上每個月，明年每個月，每個月的產量都會增加。因此，團隊正在盡最大努力工作，因為他們確實明白，相信我，我們從系統中每多出 100,000 瓶，我們就會保護更多的人。我們將減緩這種病毒的傳播。

So it's not a linear process where you start now at 100 million dose per month, of course not. So it's just going to be an acceleration process, which is why this dialogue with the government in term of allocation, and we're going to be hand to mouth for quite some time where as soon as product is made and QC'ed we will go to the government, and then they'll decide how they allocate it. And we'll just kind of be on a regular basis.

因此，這不是一個線性過程，當然不是從現在開始每月服用 1 億劑。因此，這將是一個加速過程，這就是為什麼在分配方面與政府進行對話的原因，並且我們將在相當長的一段時間內親口相傳，一旦產品製造出來並進行質量控制，我們就會去政府，然後他們會決定如何分配。我們會定期進行。

Tal, you want to take the regulatory question maybe?

塔爾，您也許想回答監管問題嗎？

Yes. Thanks, Stéphane, and thanks, Hartaj, for the question. Look, we're in active dialogue now with the regulators beyond the U.S. I think having the partnership with Lonza is a huge enabler to envision the ability to scale up and eventually supply the vaccine on a global footprint to those who need it the most. That will take shape over the coming weeks and months. The expectation I have is that we will do more than 1 trial to demonstrate the benefit.

是的。謝謝 Stéphane，也謝謝 Hartaj 提出的問題。看，我們現在正在與美國以外的監管機構進行積極對話。我認為與龍沙的合作是一個巨大的推動因素，可以設想擴大規模並最終在全球範圍內向最需要的人提供疫苗的能力。這將在未來幾周和幾個月內形成。我的期望是我們將進行不止 1 次試驗來證明其益處。

That being said, at a certain point, we'll obviously have data, both potential benefit and ultimately for benefit. By and large, that data should be applicable for filing in other territories. And so we're actively mapping it out, and our intent is absolutely to eventually be able to make this vaccine available to those who need it the most.

話雖這麼說，在某個時刻，我們顯然會擁有數據，既有潛在的好處，也有最終的好處。總的來說，這些數據應該適用於在其他地區備案。因此，我們正在積極制定計劃，我們的目的絕對是最終能夠為最需要的人提供這種疫苗。

There are no further questions at this time. Presenters, you may continue.

目前沒有其他問題。各位主講人可以繼續。

So thank you so much, everybody, for participating, and we look forward to talking to you, hosting you at the latest on June 2 for the Moderna Science Day. Stephen and his team will host. Thank you very much. Have a good day and stay safe. Bye-bye.

非常感謝大家的參與，我們期待與您交談，最晚在 6 月 2 日的 Moderna 科學日招待您。斯蒂芬和他的團隊將主持。非常感謝。祝你有美好的一天並保持安全。再見。

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。