Novavax Inc (NVAX) 2021 Q2 法說會逐字稿

Good day, everyone, and welcome to the Novavax Second Quarter 2021 Financial and Operating Results. (Operator Instructions) Please note that this event is being recorded.

大家好，歡迎來到 Novavax 2021 年第二季度財務和經營業績。 （操作員說明）請注意，此事件正在記錄中。

I'd now like to turn the conference over to Silvia Taylor, Senior Vice President, Corporate Affairs and Investor Relations. Please go ahead.

我現在想將會議轉交給公司事務和投資者關係高級副總裁 Silvia Taylor。請繼續。

Thanks, Cole. Good afternoon, everyone, and thank you to all of you who have joined today's call to discuss our second quarter 2021 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later today. We've also posted the slides we are using during today's call under Events in the Investors section of our website.

謝謝，科爾。大家下午好，感謝大家今天參加電話會議，討論我們 2021 年第二季度的運營亮點和財務業績。宣布我們結果的新聞稿目前可在我們的網站 novavax.com 上獲得，本次電話會議的音頻檔案將於今天晚些時候在我們的網站上提供。我們還在我們網站的“投資者”部分的“事件”下發布了我們在今天的電話會議中使用的幻燈片。

Joining me today is Stan Erck, President and CEO, who will provide an overview of our progress in the second quarter, our supply commitments, our regulatory time lines as well as updates on manufacturing; Dr. Filip Dubovsky, Chief Medical Officer, will discuss developments for our COVID-19 program; and John Trizzino, Chief Commercial Officer, Chief Business Officer and Interim Chief Financial Officer, will provide an update on our financial results for the quarter. Additionally, Dr. Greg Glenn, President of R&D, will be available for the Q&A section at the end of today's call.

今天加入我的是總裁兼首席執行官 Stan Erck，他將概述我們在第二季度的進展、我們的供應承諾、我們的監管時間表以及製造更新；首席醫療官 Filip Dubovsky 博士將討論我們 COVID-19 計劃的進展；首席商務官、首席商務官兼臨時首席財務官 John Trizzino 將提供我們本季度財務業績的最新信息。此外，研發總裁 Greg Glenn 博士將在今天電話會議結束時參加問答環節。

Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference, which are based on our current projections and beliefs. For example, statements relating to future financial or business performance, conditions or strategy including expectations regarding revenue, operating expenses, cash usage, clinical development of our vaccine candidates timing of future regulatory filings and actions and other anticipated milestones are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time, and actual results could differ materially from what is described in such statements. We encourage you to consult the risk factors discussed in our SEC filings for additional detail.

在我們開始準備發言之前，我需要提醒您，我們將在本次電話會議期間根據我們目前的預測和信念做出前瞻性陳述。例如，與未來財務或業務業績、條件或戰略相關的陳述，包括對收入、運營費用、現金使用、我們候選疫苗的臨床開發、未來監管備案和行動的時間以及其他預期里程碑的預期，都是前瞻性陳述。 Novavax 告誡說，這些前瞻性陳述受到許多假設、風險和不確定性的影響，這些假設、風險和不確定性會隨著時間的推移而變化，實際結果可能與此類陳述中的描述存在重大差異。我們鼓勵您查閱我們提交給美國證券交易委員會的文件中討論的風險因素以獲取更多詳細信息。

I would now like to hand the call over to Stan. For those of you following the accompanying slides, please turn to Slide 3.

我現在想把電話交給斯坦。對於那些跟隨隨附幻燈片的人，請轉到幻燈片 3。

And thank you, Silvia, and thanks to everyone for joining us today. As we start this presentation today, we can note that through the development of vaccines and treatments to date, significant progress has been made to combat the COVID-19 pandemic. However, we also note that with the continued circulation of variants and with the inequitable access to vaccines that persists in many parts of the world, Novavax' mission to bring NVX-CoV2373, to market as swiftly as possible has never been more important.

謝謝你，Silvia，也感謝大家今天加入我們。在我們今天開始本次演講時，我們可以注意到，通過迄今為止的疫苗和治療方法的開發，在抗擊 COVID-19 大流行方面取得了重大進展。然而，我們也注意到，隨著變種的持續流通以及在世界許多地方持續存在的疫苗獲取不公平現象，Novavax 盡快將 NVX-CoV2373 推向市場的使命從未像現在這樣重要。

At Novavax, this week, we took a major step forward in advancing this mission. We are announcing the filing of multiple regulatory submissions for 2373 with our partner, Serum Institute. These regulatory submissions encompass global markets, including filings with the Drug's Controller General of India as well as with regulatory agencies in Indonesia and the Philippines. We view these submissions as the first of many, bringing us 1 step closer to delivering 2373 to those in need.

本週，在 Novavax，我們在推進這一使命方面向前邁出了一大步。我們宣布向我們的合作夥伴 Serum Institute 提交多份關於 2373 的監管文件。這些監管提交的文件涵蓋全球市場，包括向印度藥物總監以及印度尼西亞和菲律賓監管機構提交的文件。我們將這些提交視為眾多提交中的第一個，使我們離將 2373 交付給有需要的人更近了一步。

In addition to these regulatory developments, I'd like to begin today's call by providing an overview of a few of our major achievements in all areas of our business since the beginning of the second quarter. We announced positive data from our PREVENT-19 pivotal Phase III trial, demonstrating 90% overall efficacy and 100% protection against moderate and severe disease. Filip will talk more about this shortly.

除了這些監管發展之外，我還想通過概述自第二季度開始以來我們在所有業務領域取得的一些主要成就來開始今天的電話會議。我們公佈了我們的 PREVENT-19 關鍵 III 期試驗的積極數據，證明了 90% 的整體療效和 100% 的中度和重度疾病保護。 Filip 稍後將對此進行更多討論。

We took major steps in exploring 2373's boosting capabilities, including positive results announced today from our 6-month booster study in our ongoing U.S. and Australia Phase II trial. In conjunction with our PREVENT-19 trial, these outstanding data make a compelling case for 2373 to become the universal booster of choice.

我們在探索 2373 的助推能力方面採取了重大步驟，包括今天在我們正在進行的美國和澳大利亞 II 期試驗中進行的為期 6 個月的助推器研究宣布的積極結果。結合我們的 PREVENT-19 試驗，這些出色的數據為 2373 成為首選的通用助推器提供了令人信服的理由。

We also continue to explore heterologous boosting alongside other vaccines in the market by participating in 2 partner-led studies: the Com-COV2 study and the CoV-Boost mix-and-match study being conducted in U.K. We furthered the global reach of our vaccine candidate, finalizing advanced purchase agreements with Gavi for 1.1 billion doses and with the European Commission announced yesterday, for up to 200 million doses of 2373.

我們還通過參與 2 項合作夥伴主導的研究，繼續探索與市場上其他疫苗一起使用的異源加強免疫：Com-COV2 研究和正在英國進行的 CoV-Boost 混合匹配研究。我們進一步擴大了疫苗的全球影響力候選人，與 Gavi 敲定了 11 億劑的預購協議，並與歐盟委員會昨天宣布，為多達 2 億劑 2373 劑。

And on the manufacturing front, we continue to work closely with our global partners to progress toward our anticipated manufacturing capacity. We have made significant progress during the quarter to ready our global supply chain for the delivery of 2373 following anticipated regulatory approvals. And today, we reaffirm our guidance to be at a monthly capacity of 100 million doses by the end of the third quarter and 150 million doses by the end of the fourth quarter.

在製造方面，我們繼續與我們的全球合作夥伴密切合作，朝著我們預期的製造能力邁進。在預期的監管批准後，我們在本季度取得了重大進展，為我們的全球供應鏈交付 2373 做好了準備。今天，我們重申我們的指導方針，即到第三季度末每月生產 1 億劑，到第四季度末每月生產 1.5 億劑。

In parallel with these developments, we have our eye on the future, advancing other candidates in our pipeline that we believe are pivotal in our ability to continuously address the world's most urgent global health needs. We are excited to share with you more about these and our many other achievements in the second quarter.

在這些發展的同時，我們著眼於未來，推進我們管道中的其他候選人，我們認為這對我們持續滿足世界上最緊迫的全球衛生需求的能力至關重要。我們很高興與您分享更多關於這些以及我們在第二季度的許多其他成就的信息。

Today, our management team will discuss clinical developments for 2373 and our financial results for the second quarter. And I will discuss updates on our supply commitments globally, progress toward regulatory approvals of 2373 and the status of our manufacturing and global supply chain. I'll also highlight our key areas of focus moving into the remainder of 2021 as well as 2022 and beyond.

今天，我們的管理團隊將討論 2373 的臨床開發和我們第二季度的財務業績。我將討論我們全球供應承諾的最新情況、2373 監管批准的進展以及我們的製造和全球供應鏈的狀態。我還將重點介紹我們在 2021 年剩餘時間以及 2022 年及以後的重點關注領域。

With that, I would now like to hand the call over to Filip to discuss our many clinical developments over the second quarter.

有了這個，我現在想把電話交給菲利普，討論我們在第二季度的許多臨床進展。

Thanks, Stan. We achieved a number of milestones in the second quarter across the clinical program, and I'll highlight a few of these in the overall context of our studies.

謝謝，斯坦。我們在整個臨床項目的第二季度實現了許多里程碑，我將在我們研究的整體背景下強調其中的一些。

So maybe switch to Slide 5, please. So here are the clinical programs that we've conducted over -- been in the development. We started off in the Phase I, Phase II in the U.S. Australia. There we established the dose level, the hemologic profile and the preliminary safety profile of the study, and this is a study that's ongoing, and we've conducted some 6-month boosting, which I'll talk about later.

所以請切換到幻燈片 5。所以這裡是我們已經進行過的臨床項目——正在開發中。我們從美國澳大利亞的第一階段、第二階段開始。在那裡，我們確定了研究的劑量水平、血液學特徵和初步安全性特徵，這是一項正在進行的研究，我們已經進行了大約 6 個月的加強，我稍後會談到。

Moved on to a Phase II study in South Africa, and this is our preliminary efficacy evaluation as well as defining the overall safety profile and exploring the efficacy and safety in a small group of HIV subjects. Moved on to our first big Phase III study in the U.K., and this is a licensure-enabling study that collected licensure-enabling safety as well as efficacy data, included a small influenza co-administration study, and I'll touch base on that data a bit later as well. And finally, we conducted a large Phase III study in the U.S. and this define the safety data and immunogenicity data as well as efficacy there in the U.S. population.

繼續在南非進行 II 期研究，這是我們的初步療效評估，並確定了總體安全性並探索了一小群 HIV 受試者的療效和安全性。繼續我們在英國的第一項大型 III 期研究，這是一項許可授權研究，收集了授權許可的安全性和有效性數據，包括一項小型流感聯合給藥研究，我將在此基礎上進行討論數據也稍晚一些。最後，我們在美國進行了一項大型 III 期研究，確定了美國人群的安全性數據和免疫原性數據以及有效性。

Let's move on to Slide 5, please. We just want to remind you of the design of the PREVENT-19 study in the U.S. and Mexico. And this is a study that included 30,000 adults age greater than 18 years of age, and it was randomized 2 to 1. And as you know, we've gone ahead and crossed these people over in a blinded crossover fashion, and the enrollment in the 2 dose crossover is almost complete.

請讓我們轉到幻燈片 5。我們只想提醒您在美國和墨西哥進行的 PREVENT-19 研究的設計。這是一項研究，包括 30,000 名 18 歲以上的成年人，它被隨機分配為 2 比 1。如你所知，我們已經繼續以一種盲目的交叉方式將這些人交叉，並且註冊2 劑量交叉幾乎完成。

Additionally, we expanded this study to include adolescents, 12 to 18 years of age, and we enrolled 2,248 of these children. The dosing is complete and the file for safety, immunogenicity and efficacy is ongoing. We have a blinded crossover planned, and we should be beginning that next week.

此外，我們將這項研究擴大到包括 12 至 18 歲的青少年，我們招募了 2,248 名這些兒童。給藥已完成，安全性、免疫原性和有效性的文件正在進行中。我們計劃了一個盲目的交叉，我們應該在下週開始。

So let's move on to Slide 6, please. Here, what I've displayed is the Kaplan-Meier curve for the primary efficacy end point. And overall, as you remember, the overall efficacy was 90%, as Stan mentioned. From this graph, you can see a couple of other things. You can see the separation of the vaccine of placebo rates began before day 21, before the second dose was given. Additionally, you can see through day 90, there's no convergence of the rights suggesting durability of protection for our vaccine. And finally, I want to remind you that all the severe cases occurred in the placebo group.

請讓我們繼續討論幻燈片 6。在這裡，我展示的是主要療效終點的 Kaplan-Meier 曲線。正如斯坦所說，總體而言，正如您所記得的那樣，總體功效為 90%。從這張圖中，您可以看到其他一些事情。您可以看到安慰劑率疫苗的分離在第 21 天之前開始，在第二劑給藥之前。此外，您可以通過第 90 天看到，權利沒有趨同，表明我們的疫苗保護的持久性。最後，我想提醒大家，所有的重症病例都發生在安慰劑組。

So let's move on to Slide 7. Slide 7 contains data, which is updated from we chatted last and this is because we got additional sequence data from the disease cases in the study. So the way this slide is designed is that the variance of concern are in red, the variance of interest are yellow in the variants that are neither of concern or interest, those that represent the strains closest to the Wuhan strain, more like matched strains are represented in green.

所以讓我們繼續看幻燈片 7。幻燈片 7 包含數據，這些數據是我們上次聊天時更新的，這是因為我們從研究中的疾病病例中獲得了額外的序列數據。所以這張幻燈片的設計方式是關注的方差是紅色的，關注的方差是黃色的，那些既不關注也不關注的變體，代表最接近武漢菌株的菌株，更像是匹配的菌株以綠色表示。

You can see the overall, we had 14 cases in the vaccine group and 63 cases in the placebo group. And I remind you, this was a 2:1 randomized study. So you can consider the placebo group, half of where we have normally been in the 1:1 randomized study. And that efficacy like we talked about was 90% with a lower bound of 83%.

您可以看到總體而言，我們在疫苗組中有 14 例，在安慰劑組中有 63 例。我提醒你，這是一項 2:1 的隨機研究。所以你可以考慮安慰劑組，我們通常在 1:1 隨機研究中的一半。就像我們談到的那樣，效率是 90%，下限是 83%。

Our key secondary endpoint was against strains that were neither variants of interest or variants of concern. That was most like the Wuhan strain. And there we had 100% efficacy. You can see there are no disease causing strains in green under the vaccine column. Against moderate and severe disease, we had 100% efficacy with a lower bound of 87% and that's irrespective of variants or nonvariants. You can see there were no cases at all in a moderate disease group under the vaccine column. And finally, we had exploratory analysis against variants of concern and interest, which we saw efficacy of 92.6%, with a lower bound of 80%.

我們的關鍵次要終點是針對既不是感興趣的變體也不是關注的變體的菌株。那最像武漢株。在那裡，我們有 100% 的療效。您可以在疫苗欄下看到綠色的沒有引起疾病的菌株。對於中度和重度疾病，我們有 100% 的療效，下限為 87%，這與變異或非變異無關。您可以在疫苗欄下看到中度疾病組根本沒有病例。最後，我們對關注和感興趣的變體進行了探索性分析，我們看到其有效性為 92.6%，下限為 80%。

We had enough cases in this study also to estimate the vaccine efficacy against B.1.1.7, which is the alpha variant first seen in the U.K. And there, we had a point estimate of 93% with a lower bound of 80%. What's remarkable across all of these end points is really the consistency of the efficacy as well as the precision and the high lower bound.

我們在這項研究中有足夠的病例來估計疫苗對 B.1.1.7 的功效，這是在英國首次出現的 alpha 變體。在那裡，我們的點估計為 93%，下限為 80%。所有這些終點的顯著之處在於功效的一致性以及精度和高下限。

So let's turn to Slide 8. Slide 8 outlines the design of the U.K. study. This is a 1:1 randomized study with 15,000 adults greater than 18 years of age. And this also we crossed the subjects over and enrollment of all the crossover vaccinations has been complete.

所以讓我們轉到幻燈片 8。幻燈片 8 概述了英國研究的設計。這是一項針對 15,000 名 18 歲以上成年人的 1:1 隨機研究。這也是我們交叉的主題，所有交叉疫苗的登記已經完成。

So let's move on to Slide 9, which shows a Kaplan-Meier curve of the primary endpoint. As we've talked about previously and it's published now, the primary efficacy was 89% overall. Once again, you can see the separation of the curves beginning right at day 21 or before. And once again, there's no convergence of the curve suggesting durability of protection. There is small red S' that denote severe disease, and they're all in the placebo group. In fact, over all of our programs, we have yet to see a severe case in the vaccinated group.

所以讓我們繼續看幻燈片 9，它顯示了主要終點的 Kaplan-Meier 曲線。正如我們之前討論過的並且現在已經發布的那樣，主要療效總體上是 89%。再次，您可以看到從第 21 天或之前開始的曲線分離。再一次，曲線沒有收斂，表明保護的持久性。有紅色的小S'表示嚴重的疾病，它們都在安慰劑組。事實上，在我們所有的項目中，我們還沒有看到接種組出現嚴重病例。

Let's turn to Slide 10. Part of this study was a influenza substudy where people received a licensed dose of influenza vaccine with the first dose of 2373. What I've highlighted here is the local and systemic reactors and events. Left-hand side is local of both placebo, flu alone, Novavax alone and then a carbonation Novavax and flu. And what you can see is that the efficacy profile is quite favorable. There's a small increase in the amount of mild symptoms, but overall, the vaccine is tolerable. And this is mimicked in the systemic side as well.

讓我們轉到幻燈片 10。這項研究的一部分是流感亞組研究，人們在第一劑 2373 中接受了許可劑量的流感疫苗。我在這裡強調的是局部和全身反應器和事件。左側是安慰劑、單獨的流感、單獨的 Novavax，然後是碳酸化 Novavax 和流感的局部。你可以看到的是，療效概況是相當有利的。輕微症狀的數量略有增加，但總體而言，疫苗是可以耐受的。這在系統方面也得到了模仿。

The influenza HAIs and seroconversion were preserved with coadministration, and I'll detail this data in a subsequent slide. And I'll remind you that the overall efficacy of the study was 89.7%. And when we did a subgroup analysis of those in the flu study, we saw that the efficacy was preserved at 87.5% even though there was a very small subgroup of only 400 individuals.

流感 HAI 和血清轉化通過共同給藥得以保存，我將在隨後的幻燈片中詳細介紹這些數據。我會提醒你，這項研究的總體療效是 89.7%。當我們對流感研究中的人進行亞組分析時，我們發現即使只有 400 人的非常小的亞組，療效仍保持在 87.5%。

So let's go to Slide 11 and look at immuno. So as displayed on Slide 11 is the HAI responses of people who received the license vaccine alone compared to when given with 2373. On the left-hand side, you can see the quadrivalent data, and this is people who were aged 16 to 64 years of age who by standards in the U.K. received quadrivalent cell culture influenza vaccine.

所以讓我們轉到幻燈片 11，看看免疫。因此，如幻燈片 11 所示，單獨接種許可疫苗的人與接種 2373 的人相比的 HAI 反應。在左側，您可以看到四價數據，這是 16 至 64 歲的人符合英國標準的接受四價細胞培養流感疫苗的年齡。

The older subjects received adjuvanted vaccine and they're on the right-hand panel. This was a very small group of older subjects because the public health infrastructure in the U.K. works very well. And we only had 16 subjects who received our vaccine plus influenza, so the confidence intervals are quite wide.

年齡較大的受試者接受了佐劑疫苗，他們在右側面板上。這是一小部分年齡較大的受試者，因為英國的公共衛生基礎設施運作良好。而且我們只有 16 名受試者接受了我們的疫苗和流感，因此置信區間非常寬。

However, on the left-hand side, these were a larger group of individuals, so we can be more precise in our estimates of the immune response to the flu vaccine. And you can see that the HAI responses to flu vaccine were preserved for all 4 strains. In fact, numerically, the HAI responses as well as seroconversion responses were higher in the co-administrated vaccine compared to the vaccine alone.

然而，在左側，這些是更大的個體群體，因此我們可以更準確地估計對流感疫苗的免疫反應。您可以看到所有 4 株病毒對流感疫苗的 HAI 反應都得到了保留。事實上，從數字上看，與單獨的疫苗相比，共同施用的疫苗中的 HAI 反應和血清轉化反應更高。

So let's move on the next slide, Slide 12, please. This is a comparison of the efficacy results from our 2 Phase III studies that were independently conducted and powered. You can see that the efficacy was remarkably consistent 89% in the U.K. study and 90% in the U.S. study, less than a single percentage point difference in the 2 studies indicating that the vaccine response is very robust.

請讓我們繼續下一張幻燈片，第 12 張幻燈片。這是對我們獨立進行和支持的 2 項 III 期研究的療效結果的比較。您可以看到，英國研究中 89% 和美國研究中 90% 的療效非常一致，這兩項研究中的差異不到一個百分點，表明疫苗反應非常強勁。

Against matched strain efficacy, in the U.K., we saw a 96% against the prototype. And in the U.S., Mexico, where we had greater variant spreading, we saw 100% efficacy against those who were not variants of concern or interest. Again, efficacy against variants in the U.K. was 86% against alpha, in the U.S., 93% against alpha, and overall, in the U.S., variance of concern and interest 92%. So this vaccine works quite well against variance impact.

在英國，針對匹配的應變效率，我們看到了 96% 的原型。在美國，墨西哥，我們有更大的變異傳播，我們看到對那些不是關注或感興趣的變異的人有 100% 的療效。同樣，在英國，針對 alpha 的變體功效為 86%，在美國，針對 alpha 的功效為 93%，總體而言，在美國，關注和興趣的方差為 92%。所以這種疫苗在對抗變異影響方面效果很好。

And finally, we have this observation that in the U.S., our efficacy in severe disease was 100%. We didn't have enough cases in the U.K. to estimate efficacy, but all severe cases were in the placebo group. And I would say also in the South Africa, all the severe and hospitalized cases were in the placebo group as well.

最後，我們觀察到，在美國，我們對嚴重疾病的療效是 100%。我們在英國沒有足夠的病例來估計療效，但所有嚴重病例都在安慰劑組。我還要說，在南非，所有重症和住院病例也都在安慰劑組中。

So let's move on to Slide 13, please. Slide 13 is a display of the South Africa Phase IIb design. And the only point I want to make here is that enrollment of all the crossover and boost vaccinations has started. And this design is a little bit different from the other 2 in that the people who received placebo initially got 2 doses of vaccine at 6 months. However, the people who got 2 doses initially got a single boost dose at 6 months. And this will allow us to collect additional boost data, both from a safety and immunogenicity perspective in this population.

請讓我們轉到幻燈片 13。幻燈片 13 展示了南非 IIb 期設計。我想在這裡指出的唯一一點是，所有交叉疫苗和加強疫苗的註冊已經開始。而且這種設計與其他 2 種設計略有不同，因為接受安慰劑的人最初在 6 個月時接種了 2 劑疫苗。然而，接種 2 劑的人最初在 6 個月時接種了單次加強劑。這將使我們能夠從該人群的安全性和免疫原性角度收集額外的增強數據。

So let's move to Slide 14, please. Slide 14 despites the study design of our Phase IIb study that we started in the U.S. and Australia over a year ago. Here, we enrolled 1,208 adults aged 18 to 84, and half of those were adults who are greater than 60 years of age. After the 2-dose primary series, we went back and we boosted some of these select individuals at 6 months of -- to 6 months.

請讓我們轉到幻燈片 14。儘管我們一年多前在美國和澳大利亞開始了 IIb 期研究的研究設計，但幻燈片 14。在這裡，我們招募了 1,208 名 18 至 84 歲的成年人，其中一半是 60 歲以上的成年人。在 2 劑初級系列之後，我們返回並在 6 個月時將其中一些選定的個體提高到 6 個月。

We plan an additional boost at 1 year. And the groups that I've highlighted in red -- perhaps click, please. They are highlighted in red and on the printed slides are the group will be talking about. These are people who received 2 doses initially at day 0 and 21, and half of them were boosted at day 189 with a 5-microgram dose of 2373.

我們計劃在 1 年進行一次額外的提升。我用紅色突出顯示的組-- 請點擊。它們以紅色突出顯示，並且在打印的幻燈片上是小組將要討論的內容。這些人最初在第 0 天和第 21 天接受了 2 劑，其中一半在第 189 天接受了 5 微克劑量 2373 的加強。

Let's go to Slide 15, please. So Slide 15 displays adverse events comparing dose 1 to dose 2 to dose 3. And we've displayed adverse events overall, severe adverse events, medically attended adverse events, SAEs, discontinuations and a potentially immune-mediated medical complications. And you can see there's a lot of consistency between dose 1, 2 and 3, and there is an excess of adverse events in dose 3. And the rates of severe AEs and SAEs are very low indeed. So this data was reviewed by our external safety motoring committee, and they voiced no concerns and suggest that we proceed with vaccination.

請轉到第 15 張幻燈片。因此，幻燈片 15 顯示了比較劑量 1、劑量 2 和劑量 3 的不良事件。我們展示了總體不良事件、嚴重不良事件、醫療上的不良事件、SAE、停藥和潛在的免疫介導的醫療並發症。你可以看到第 1 劑、第 2 劑和第 3 劑之間有很多一致性，第 3 劑中有過多的不良事件。嚴重 AE 和 SAE 的發生率確實非常低。因此，我們的外部安全駕駛委員會審查了這些數據，他們沒有表示任何擔憂，並建議我們繼續進行疫苗接種。

Let's move to Slide 16, please. Slide 16 highlights the local systemic reactions after vaccination. And what you can see is for the local reactions, we had an increase of (inaudible) for dose 2 and then additionally for dose 3, which is completely expected with additional vaccinations. What you can also see is that more than 90% of the reactions were either none, mild or moderate with a very low rate of grade 3 or more events. The median duration was short, less than 2 days median, with the exception of erythema, which was 2.5 days.

請移到第 16 張幻燈片。幻燈片 16 突出顯示了疫苗接種後的局部全身反應。您可以看到局部反應，我們在第 2 劑和第 3 劑中增加了（聽不清），這完全可以預料到額外的疫苗接種。您還可以看到，超過 90% 的反應不是無、輕度或中度，3 級或以上事件的發生率非常低。中位持續時間短，中位小於 2 天，紅斑除外，為 2.5 天。

Let's go to Slide 17, please. Slide 17 is the companion slide, which details the systemic symptoms, and it's very similar to what we saw previously. As expected, the symptoms increased with dosing. And with the exception of fatigue, more than 90% reported either none, mild or moderate symptoms, and the event rate was quite low overall. Once again, the median duration was short, less than 1 day with the exception of muscle pain, which is 2 days.

請轉到第 17 張幻燈片。幻燈片 17 是配套幻燈片，詳細介紹了全身症狀，與我們之前看到的非常相似。正如預期的那樣，症狀隨著給藥而增加。除了疲勞之外，超過 90% 的人報告了無症狀、輕度或中度症狀，並且總體事件發生率相當低。再一次，中位持續時間很短，不到 1 天，肌肉疼痛除外，即 2 天。

Let's move to Slide 18 and look at some immuno data. What I've detailed here is the immune response, the immunokinetics of anti-IgG response conducted with our validated assay, and this is against a prototype. So you can see the peak response after 2 doses on day 35 was 41,000, which decreased over time. When we boosted it, it rose up to over 200,000 units. And this represents a 4.6-fold increase compared to the peak seen after primary vaccination.

讓我們轉到幻燈片 18，看看一些免疫數據。我在這裡詳細介紹的是免疫反應，即使用我們經過驗證的測定法進行的抗 IgG 反應的免疫動力學，這是針對原型的。因此，您可以看到在第 35 天服用 2 劑後的峰值反應為 41,000，隨著時間的推移而下降。當我們提升它時，它上升到超過 200,000 個單位。與初次接種疫苗後的峰值相比，這增加了 4.6 倍。

Go to Slide 19, please. This is the same data, but it's displayed by age. And the point here is that in both younger and the older adults, we had a good impact from boosting. In fact, the impact to older adults was even higher than younger adults to the boost, which is likely because they have slightly lower titers to begin with.

請轉到幻燈片 19。這是相同的數據，但按年齡顯示。這裡的重點是，在年輕人和老年人中，我們都從提升中獲得了很好的影響。事實上，對老年人的影響甚至高於年輕人對提升的影響，這可能是因為他們開始時的滴度略低。

Let's move on to Slide 20, please. So all the data I've shown you up until now from an immunogenicity perspective, was against our validated anti-spike for the prototype strain. We also developed a validated anti-spike assay for the beta variant, so the 1 was first identified in South Africa. And you can see we got a really nice boost with that as well. From a 4,400 a day at the 6-month time period to over almost 170,000 a day 217. So what we have here is some evidence that the vaccine has potential to cross react against variants. know this is true because we have good efficacy against variants.

請讓我們轉到幻燈片 20。因此，到目前為止，從免疫原性的角度來看，我向您展示的所有數據都與我們驗證的原型菌株的抗尖峰相反。我們還為 β 變體開發了一種經過驗證的抗尖峰檢測，因此 1 首次在南非被發現。你可以看到我們也得到了很好的提升。從 6 個月期間的每天 4,400 人增加到每天近 170,000 人 217。所以我們這裡有一些證據表明疫苗有可能對變體產生交叉反應。知道這是真的，因為我們對變體有很好的療效。

Let's go to Slide 11, please. Slide 21 displays wild-type neutralization. Once again, this is against the prototype strain. And you can see very similar patterns to what we saw with the IgG responses at peak day 35, midyear at month 6 and boosted to over 6,000 with an increased fold rise in the older adults.

請轉到幻燈片 11。幻燈片 21 顯示野生型中和。再一次，這與原型菌株背道而馳。您可以看到與我們在第 35 天、第 6 個月的年中峰值時看到的 IgG 反應非常相似的模式，並且隨著老年人的倍數增加而增加至 6,000 以上。

Let's move on to Slide 22. So on this slide, what I've displayed is the peak responses that we observed in the U.K. Phase III study. Next to that, in the middle column is in the immune responses that we observed in the PREVENT-19 study. And finally, on the right-hand side, I have the boost data we just showed. Additionally, I've put in the vaccine efficacy as the top of the Phase III studies. And what you can see is that compared to the 2 Phase III programs, where we showed efficacy, not only against variants, but also against non-variants we had a 4.7 to 4.4 fold rise. This gives us a lot of hope that we're going to increase durability of protection as well as protection overall.

讓我們繼續看幻燈片 22。所以在這張幻燈片上，我展示的是我們在英國 III 期研究中觀察到的峰值反應。接下來，中間一列是我們在 PREVENT-19 研究中觀察到的免疫反應。最後，在右側，我有我們剛剛展示的提升數據。此外，我已將疫苗功效置於 III 期研究的首位。您可以看到，與 2 個 III 期項目相比，我們展示了療效，不僅針對變體，而且針對非變體，我們的療效提高了 4.7 到 4.4 倍。這給了我們很大的希望，即我們將提高保護的持久性以及整體保護。

Let's move on to the next slide. This slide is a companion slide which shows wild-type microneutralization responses. And once again, you can see the peak responses in the U.K. as well as the U.S. Phase III study and that we had a large boost from these with our -- in our Phase II program.

讓我們繼續看下一張幻燈片。此幻燈片是顯示野生型微中和反應的配套幻燈片。再一次，您可以看到英國和美國 III 期研究中的峰值反應，並且我們在我們的 II 期計劃中從這些中獲得了巨大的推動。

I guess a couple things to point out here. One of them is that the fold rise is greater for the microneutralization than for IgG. And this suggests the potential maturation of immune response with greater spread. I'll show you a little bit more data about this in the next couple slides. We were quite curious to understand our immune response to these vaccines -- to this vaccine because we had such good efficacy against the variants.

我想這裡要指出幾件事。其中之一是微量中和的倍數上升大於 IgG。這表明免疫反應的潛在成熟與更大的傳播。在接下來的幾張幻燈片中，我將向您展示更多關於此的數據。我們很想了解我們對這些疫苗的免疫反應——對這種疫苗的免疫反應，因為我們對這些變體有很好的療效。

Let's move to Slide 24. Slide 24 is a pretty complicated slide, so I'm going to take my time going through this data. We developed a functional human ACE2 inhibition assay. So what we did is we developed spike proteins from the prototype strain, delta, beta and alpha. And what we do in this assay is we show that antibodies that are generated by vaccination can block that interaction. So this is a functional assay.

讓我們轉到幻燈片 24。幻燈片 24 是一張非常複雜的幻燈片，所以我將花時間瀏覽這些數據。我們開發了一種功能性人類 ACE2 抑制試驗。所以我們所做的是我們從原型菌株 delta、beta 和 alpha 中開發了刺突蛋白。我們在這個試驗中所做的是我們證明疫苗接種產生的抗體可以阻止這種相互作用。所以這是一個功能分析。

On the left-hand side, you can see the day 35 data. So the day 35 data is the peak response after 2 doses. And in black, you can see the prototype; in blue you can delta; in red, beta; and in green, alpha. And I want to remind you that the efficacy against the prototype was between 96% and 100% and against alpha was between 86% and 94%. And the other variants displayed functional immune responses that lie between those 2. So we have high hope that the efficacy against those variants will be somewhere between that, which we saw for the prototype and that which we saw for alpha.

在左側，您可以看到第 35 天的數據。所以第 35 天的數據是 2 劑後的峰值反應。並且在黑色中，您可以看到原型；在藍色你可以三角洲；紅色，測試版；和綠色，阿爾法。我想提醒你，針對原型的功效在 96% 到 100% 之間，針對 alpha 的功效在 86% 到 94% 之間。其他變體顯示出介於這兩者之間的功能性免疫反應。因此，我們非常希望針對這些變體的功效將介於我們看到的原型和我們看到的 alpha 之間。

On the right-hand side, you can see the responses after boosting, and we had between a sixfold to 10.8-fold increase over what we saw at day 35. Importantly, Delta is getting a lot of attention. You can see that it had a 6.6-fold rise over the peak response after the primary vaccination series.

在右側，您可以看到提升後的反應，與我們在第 35 天看到的相比，我們的反應增加了 6 倍到 10.8 倍。重要的是，Delta 得到了很多關注。您可以看到它比初次接種系列後的峰值反應增加了 6.6 倍。

Another couple of observations on this part of the graph. One of them is that we left no one behind. You can see that 100% of the people were boosted into high levels, especially when you compare the levels we've seen here to those which were shown to be protected on the left-hand side of the graph. Another observation is that we really have very consistent responses across the 3 variants, and this we attribute really to the maturation of the immune response with boosting.

關於這部分圖表的另外幾個觀察結果。其中之一是我們沒有留下任何人。你可以看到 100% 的人被提升到了高水平，特別是當你將我們在這裡看到的水平與圖表左側顯示的受到保護的水平進行比較時。另一個觀察結果是，我們在 3 種變體中確實有非常一致的反應，我們將這真正歸因於免疫反應的成熟與加強。

So let me move on to Slide 25, which is a quick clinical summary. So we have data from 2 independent Phase III studies that have shown high levels of vaccine efficacy: in the U.K., 89.7% overall; in the U.S. over 90%. And both of these studies have shown strong efficacy against variants, against both the B.1.1.7, the alpha variant as well as all variants of concern and interest in the U.S. study.

所以讓我繼續看幻燈片 25，這是一個快速的臨床總結。因此，我們有來自 2 項獨立 III 期研究的數據，這些研究顯示出高水平的疫苗效力：在英國，總體為 89.7%；在美國超過 90%。這兩項研究都顯示出對變體的強大功效，包括 B.1.1.7、alpha 變體以及美國研究中關注和感興趣的所有變體。

Next slide. I've shared with you today about our single-dose boosting at 6 months and this significantly increases immune responses. Both wild-type neutralization as well as anti-spike IgG were boosted between 4.3 to 6.4-fold over the peak primary vaccination response. In our functional hACE-2 immune response, we were able to take this against alpha, beta and delta, not only in our primary vaccination series, but also after we boosted it and these went from a peak of 6.6- to 10.8-fold increase. We think that this data will support the use of our vaccine in a boosting campaign.

下一張幻燈片。我今天與您分享了我們在 6 個月時的單劑量加強，這顯著提高了免疫反應。野生型中和和抗尖峰 IgG 均比初始疫苗接種反應峰值高 4.3 至 6.4 倍。在我們的功能性 hACE-2 免疫反應中，我們能夠針對 alpha、beta 和 delta，不僅在我們的主要疫苗系列中，而且在我們加強它之後，這些從 6.6 倍的峰值增加到 10.8 倍.我們認為這些數據將支持我們的疫苗在助推運動中的使用。

And furthermore, we shared data with you that the co-administration with flu doesn't adversely impact the influenza immune response. So we have high hopes that our boosting could be incorporated into the annual influenza vaccination campaign.

此外，我們與您分享了與流感合用不會對流感免疫反應產生不利影響的數據。因此，我們寄予厚望，希望我們的加強能被納入年度流感疫苗接種活動。

So let me turn this back over to Stan.

所以讓我把這個轉回給斯坦。

Thanks, Filip. Moving to Slide 27, we provide an overview of our supply commitments to date. There remains significant demand for 2373 globally with vaccination rates varying widely from country to country. We continue to see significant opportunity in ex U.S. markets to provide supply for initial vaccinations. In high-income countries, we believe our technology well positions us to become the booster of choice.

謝謝，菲利普。轉到幻燈片 27，我們概述了我們迄今為止的供應承諾。全球對 2373 的需求仍然很大，各國的疫苗接種率差異很大。我們繼續在美國以外的市場看到為初始疫苗提供供應的重要機會。在高收入國家，我們相信我們的技術使我們能夠成為首選的助推器。

Yesterday, we were pleased to announce the finalization of an advanced purchase agreement with the European Commission for the purchase of up to 200 million doses of 2373. We expect to begin delivery of initial doses following anticipated regulatory approval from the European Medicines Agency. And through this agreement, 2373 is expected to be the first protein-based COVID-19 vaccine available in the European Union.

昨天，我們很高興地宣布與歐盟委員會就購買多達 2 億劑 2373 的預購協議敲定。我們預計將在獲得歐洲藥品管理局的監管批准後開始交付初始劑量。通過這項協議，2373 有望成為歐盟第一個基於蛋白質的 COVID-19 疫苗。

Additionally, we finalized our APA with Gavi reaffirming our commitment to fair and equitable access to 2373, the cumulative 1.1 billion doses that we, alongside our partner, Serum Institute Committed to the COVAX Facility will be critical in ensuring widespread initial vaccination, particularly in developing markets.

此外，我們與 Gavi 敲定了 APA，重申了我們對公平和公平獲取 2373 的承諾，我們與合作夥伴血清研究所共同致力於 COVAX 設施的累計 11 億劑疫苗對於確保廣泛的初始疫苗接種至關重要，特別是在發展中國家市場。

So let's turn to our regulatory and manufacturing updates. I'm excited to discuss our progress during the second quarter for 2 key areas: the first is our progress toward de regulatory authorization of 2373 and anticipated time lines for completing our filings; the second is our progress towards achieving our anticipated manufacturing capacity and our expectations for the supply of 2373 globally. I will then discuss our key areas of strategic focus for the remainder of 2021 as well as our expectations moving into 2022 and beyond.

因此，讓我們轉向我們的監管和製造更新。我很高興在第二季度討論我們在兩個關鍵領域取得的進展：首先是我們在解除監管授權 2373 方面取得的進展，以及完成我們備案的預期時間表；第二個是我們在實現我們預期的製造能力和我們對全球 2373 供應的預期方面取得的進展。然後，我將討論我們在 2021 年剩餘時間內的關鍵戰略重點領域，以及我們對 2022 年及以後的預期。

Starting with our efforts to gain regulatory authorization 2373 this week, by submitting its first regulatory filings in multiple countries, Novavax has graduated to a new level.

從我們本週努力獲得監管授權 2373 開始，通過在多個國家提交其第一份監管文件，Novavax 已經升級到一個新的水平。

Please turn to Slide 28. As I mentioned earlier on today's call, we filed regulatory submissions in multiple markets in partnership with Serum Institute. These regulatory submissions for emergency use authorization were filed with the Drugs Controller General of India and regulatory agencies in Indonesia and the Philippines.

請轉到幻燈片 28。正如我在今天的電話會議之前提到的，我們與 Serum Institute 合作在多個市場提交了監管文件。這些緊急使用授權的監管提交已提交給印度藥品總局以及印度尼西亞和菲律賓的監管機構。

We expect to file for emergency use listing to the World Health Organization in August. We expect that the granting of emergency use listing by the WHO will open the door for exports to numerous countries, many of whom are participating in the COVAX Facility. These major milestones reflect the strength of our continued partnership with Serum Institute and mark an important first step toward accelerating global equitable access to 2373. We expect these submissions to be the first of many with additional filings expected in the coming months.

我們預計將於 8 月向世界衛生組織提交緊急使用清單。我們預計，世界衛生組織批准緊急用途清單將為出口到許多國家打開大門，其中許多國家都參與了 COVAX 基金。這些重要里程碑反映了我們與 Serum Institute 持續合作的實力，標誌著朝著加速全球公平獲取 2373 邁出了重要的第一步。我們預計這些提交將是未來幾個月預計會有更多申請中的第一個。

We are also working on submissions that will eventually cover the rest of the world because we're dealing with regulatory agencies that have different requirements and in countries that have different needs, these regulatory filings and the subsequent approval processes will occur over a series of months. Let me cover the ones that we are working on now.

我們還在努力提交最終將覆蓋世界其他地區的申請，因為我們正在與有不同要求的監管機構打交道，並且在有不同需求的國家/地區，這些監管備案和隨後的批准流程將持續數月.讓我介紹一下我們現在正在研究的那些。

In the U.S., we are continuing to work with the FDA in collaboration with our team that we now refer to as the U.S. government to finalize our filing package for authorization under emergency use authorization. The current time line looks to now be in the fourth quarter, hopefully early in the fourth quarter. This time line is based upon a couple of factors. First, the completion of validation of analytical methods. And additionally, we have many complex critical activities as part of our finalization of our authorization submission that are being carried out with multiple third parties. Importantly, I believe all the key components are in place to achieve our filing within the fourth quarter.

在美國，我們將繼續與 FDA 合作，與我們現在稱為美國政府的團隊合作，以最終確定我們在緊急使用授權下獲得授權的文件包。目前的時間線現在看起來是在第四季度，希望在第四季度初。這條時間線基於幾個因素。一是完成分析方法的驗證。此外，作為我們完成授權提交的一部分，我們有許多複雜的關鍵活動，這些活動正在與多個第三方進行。重要的是，我相信所有關鍵組件都已到位，可以在第四季度完成我們的申報。

The good news is that the EUA pathway remains open. Peter Marks, Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration was quoted in a Bloomberg interview this week saying that, "There probably is going to be a point at which we stopped giving emergency use authorizations. But right now, one wouldn't want to rule out continuing to give emergency use authorizations." We still don't have an approved protein-based vaccine, for instance, and there are some people here that might be a very good alternative. So I think that's good news.

好消息是 EUA 途徑仍然開放。本週，美國食品和藥物管理局生物製品評估和研究中心主任彼得·馬克斯在接受彭博社採訪時說：“我們可能會停止給予緊急使用授權。但現在，人們不想排除繼續給予緊急使用授權的可能性。”例如，我們仍然沒有批准的基於蛋白質的疫苗，這裡有些人可能是一個很好的選擇。所以我認為這是個好消息。

So regarding our progress toward completing regulatory filings in other geographies, we continue to advance our program with the MHRA, which is the U.K. regulatory agency, we are targeting to submit to MHRA in the third quarter, but as with all applications, this may change based on discussions planned for later this month to support our planned application in the third quarter. Given that there are many countries who will rely on MHRA authorizations as a basis for their own regulatory approvals, this is another important global filing.

因此，關於我們在其他地區完成監管備案的進展，我們繼續與英國監管機構 MHRA 一起推進我們的計劃，我們的目標是在第三季度提交給 MHRA，但與所有申請一樣，這可能會改變基於計劃在本月晚些時候進行的討論，以支持我們在第三季度計劃的應用程序。鑑於許多國家將依靠 MHRA 授權作為其自身監管批准的基礎，這是另一個重要的全球備案。

In addition to filing with the MHRA, we are preparing to file an additional important markets within weeks of the MHRA filing, including the European Medicines Agency, the Australian Therapeutic Goods Administration, in Health Canada and in New Zealand through MedSafe. As always, gaining regulatory authorization for 2373 remains a top priority as we move into the remainder of 2021, and we continue to work tirelessly with regulatory authorities to complete our filings. We view the completion of multiple filings announced today as a significant first step but only the first step in gaining authorization of 2373 around the world.

除了向 MHRA 提交申請外，我們還準備在 MHRA 提交後的幾週內向其他重要市場提交申請，包括歐洲藥品管理局、澳大利亞治療用品管理局、加拿大衛生部和新西蘭通過 MedSafe。與往常一樣，隨著我們進入 2021 年剩餘時間，獲得 2373 的監管授權仍然是重中之重，我們將繼續與監管機構不懈努力以完成我們的備案。我們認為今天宣布的多項申請的完成是重要的第一步，但只是在全球獲得 2373 授權的第一步。

So moving to Slide 29. Next, I will discuss our anticipated time line towards achieving our manufacturing capacity and progress made during the quarter to prepare our global supply chain for commercialization. Today, we remain on track to achieve manufacturing capacity of 100 million doses per month by the end of the third quarter of '21 and 150 million doses per month by the end of the fourth quarter of '21. Our manufacturing and developments during the second quarter reflected our progress toward reaching our anticipated manufacturing capacity as well as our efforts to proactively build our -- for future expansion.

所以轉到幻燈片 29。接下來，我將討論我們實現製造能力的預期時間線以及本季度取得的進展，為我們的全球供應鏈商業化做好準備。今天，我們仍有望在 21 年第三季度末實現每月 1 億劑的生產能力，到 21 年第四季度末實現每月 1.5 億劑的生產能力。我們在第二季度的製造和發展反映了我們在達到預期製造能力方面取得的進展，以及我們為未來擴張積極建設我們的努力。

Notably, we took additional strides towards producing 2373 in Canada, initiated technology transfer to produce 2373 at the National Research Council's Biologics Manufacturing Center in Canada. We're excited to see such progress at this facility, which completed construction in June '21. We expect to begin large-scale GMP manufacturing once the facility receives regulatory approval from Health Canada. The production of 2373 in Canada will represent the first manufacturing capacities in the country for a COVID-19 vaccine.

值得注意的是，我們在加拿大生產 2373 方面取得了更大的進步，並在加拿大國家研究委員會的生物製品製造中心啟動了技術轉讓以生產 2373。我們很高興看到這個設施在 21 年 6 月完成了建設，取得了這樣的進展。一旦該設施獲得加拿大衛生部的監管批准，我們預計將開始大規模的 GMP 生產。在加拿大生產 2373 將代表該國第一個生產 COVID-19 疫苗的能力。

We expect our global supply chain to support expansion of distribution 2373 beginning in the second half of '21, and we anticipate shipping vaccine upon anticipated regulatory approvals. Initially, our doses may be prioritized to low-income countries where we'll be able to support critical unmet demand for primary vaccinations. We view our partnership with Serum Institute as a key component in delivery supply to low and middle income countries, including Serum Institute's contribution to the COVAX Facility.

我們預計我們的全球供應鏈將支持從 21 年下半年開始擴大分銷 2373，我們預計在預期的監管批准後運送疫苗。最初，我們的劑量可能會優先用於低收入國家，在那裡我們將能夠支持對初級疫苗接種的嚴重未滿足需求。我們將與 Serum Institute 的合作夥伴關係視為向中低收入國家交付供應的關鍵組成部分，包括 Serum Institute 對 COVAX 設施的貢獻。

We remain confident in our ability to deliver upon our bilateral supply agreements, including with the European Commission as well as our commitment to the U.S. government, especially as the need for boosters increase among high-income countries around the world.

我們對履行雙邊供應協議的能力仍然充滿信心，包括與歐盟委員會以及我們對美國政府的承諾，特別是在全球高收入國家對助推器的需求增加的情況下。

With that, I'd now like to hand over the call to John to discuss our financial results for the quarter.

有了這個，我現在想把電話交給約翰，討論我們本季度的財務業績。

Thanks, Stan. Moving to Slide 30. We issued our second quarter earnings press release, which discusses our financial results for the quarter, and we'll be filing our 10-Q for the second quarter 2021 today, which includes details on important business and financing events during the second quarter. With that said, I'd like to provide a high-level overview of some of our key financial results for the quarter.

謝謝，斯坦。轉到幻燈片 30。我們發布了第二季度收益新聞稿，其中討論了我們本季度的財務業績，我們今天將提交 2021 年第二季度的 10-Q，其中包括有關重要業務和融資事件的詳細信息第二季度。話雖如此，我想對我們本季度的一些關鍵財務業績進行高級概述。

Novavax's revenue in the second quarter 2021 was $298 million compared to $36 million in the same period in 2020. This increase was due to increased development activities related to CoV2373 under the U.S. government and CEPI agreements.

Novavax 在 2021 年第二季度的收入為 2.98 億美元，而 2020 年同期為 3600 萬美元。這一增長是由於美國政府和 CEPI 協議下與 CoV2373 相關的開發活動增加。

During the quarter, we filed an ATM offering in June 2021, which allowed us to issue and sell up to $500 million in gross proceeds of common stock. As of June 30, 2021, no shares have been issued under the new ATM. We ended the quarter with a strong cash position of $2.1 billion compared to $806 million at year-end 2020. This increase in cash was primarily due to $1.1 billion in payments received under advanced purchase agreements, the timing of payments to third parties, and the $565 million of ATM funding in Q1.

在本季度，我們於 2021 年 6 月提交了 ATM 發行，這使我們能夠發行和出售高達 5 億美元的普通股總收益。截至 2021 年 6 月 30 日，新 ATM 下未發行任何股票。截至本季度末，我們擁有 21 億美元的強勁現金頭寸，而 2020 年底為 8.06 億美元。現金增加的主要原因是根據預先購買協議收到的 11 億美元付款、向第三方付款的時間以及第一季度的 ATM 資金為 5.65 億美元。

With that, I would now like to turn the call back to Stan to discuss our strategic focus for the months to come.

有了這個，我現在想把電話轉回斯坦，討論我們未來幾個月的戰略重點。

Thanks, John. Turning to Slide 31. I will lastly highlight our key areas of strategic focus for the remainder of '21. These include the following: completing additional regulatory filings and gaining regulatory authorizations of 2373 in multiple markets; readying our global supply chain for commercialization and reaching our anticipated manufacturing capacity of 150 million doses per month; beginning expansive distribution of 2373; and finally, advancing life cycle management of 2373.

謝謝，約翰。轉到幻燈片 31。我將最後強調我們在 21 年剩餘時間內的戰略重點關鍵領域。其中包括：完成額外的監管備案並在多個市場獲得 2373 的監管授權；使我們的全球供應鍊為商業化做好準備，並達到我們預期的每月 1.5 億劑的製造能力；開始廣泛分佈2373；最後，推進2373全生命週期管理。

We believe these near-term priorities are critical in laying the foundation for commercial success in the coming years. As we look towards 2022 and beyond, we believe that the clinical development of 2373 to date positions our vaccine to become the universal boost of choice and the preferred vaccine for annual revaccination.

我們認為，這些近期優先事項對於為未來幾年的商業成功奠定基礎至關重要。當我們展望 2022 年及以後，我們相信 2373 迄今為止的臨床開發使我們的疫苗成為普遍的選擇和年度再接種的首選疫苗。

Our differentiated technology as well as our global chain will enable us to support demand in an anticipated booster market in 2022 and beyond. As we continue to develop other areas of our pipeline, both our variant strain and combination vaccine programs will play a meaningful role in our long-term success, enabling us to effectively address continued evolution of COVID-19 alongside seasonal influenza.

我們的差異化技術以及我們的全球鏈將使我們能夠在 2022 年及以後支持預期的助推器市場的需求。隨著我們繼續開發我們管道的其他領域，我們的變異株和聯合疫苗計劃都將在我們的長期成功中發揮重要作用，使我們能夠有效地應對 COVID-19 與季節性流感的持續演變。

Before opening the call to Q&A, I wanted to take a moment to acknowledge and thank the Novavax clinical trial participants around the world. These individuals made a crucial and life-saving contribution during an unprecedented global pandemic. And now they are the reasons that some countries are starting to reopen. I and my colleagues have heard from many of you about your experiences, and we are grateful for your generosity.

在打開問答電話之前，我想花點時間感謝和感謝世界各地的 Novavax 臨床試驗參與者。這些人在史無前例的全球大流行期間做出了至關重要的挽救生命的貢獻。現在，它們是一些國家開始重新開放的原因。我和我的同事從你們中的許多人那裡聽說過你們的經歷，我們感謝你們的慷慨。

We know that in some situations, clinical trial participants are being challenged with respect to proof of vaccination. We want these folks to know that we are doing everything we can to advocate for them. This includes working with governments to make the case that those who participate in clinical trials should be considered fully vaccinated from a public health perspective and treated in the same manner as someone who has received a deployed vaccine. These are unprecedented questions, and we are supporting the efforts to devise solutions.

我們知道，在某些情況下，臨床試驗參與者在疫苗接種證明方面面臨挑戰。我們希望這些人知道我們正在盡一切努力為他們辯護。這包括與政府合作，證明從公共衛生的角度來看，參與臨床試驗的人應被視為完全接種疫苗，並以與接種疫苗的人相同的方式進行治療。這些都是前所未有的問題，我們正在支持制定解決方案的努力。

While we can't control the decisions that countries and private entities make around vaccine mandates, we will also do our best to keep you informed on our progress. I want to reiterate that we are working day and night to finalize the requirements for the submission process, and I want to personally thank all of the clinical trial participants for their vital contributions to public health during the pandemic. For those who have reached out to us directly, we appreciate you willingness to know about your situation.

雖然我們無法控制國家和私營實體圍繞疫苗授權做出的決定，但我們也會盡最大努力讓您了解我們的進展。我想重申，我們正在夜以繼日地工作以最終確定提交過程的要求，我要親自感謝所有臨床試驗參與者在大流行期間為公共衛生做出的重要貢獻。對於那些直接與我們聯繫的人，我們感謝您願意了解您的情況。

I'd also like to thank our entire Novavax team for their continued dedication an over incredibly busy quarter. These tireless efforts, combined with the support of our partners globally, bring us significantly closer to delivering our COVID-19 vaccine.

我還要感謝我們整個 Novavax 團隊在一個異常繁忙的季度中的持續奉獻。這些不懈的努力，加上我們全球合作夥伴的支持，使我們離交付 COVID-19 疫苗更近了一步。

And I would now like to turn it over to the operator for Q&A.

我現在想把它交給接線員進行問答。

(Operator Instructions) Our first question today will come from Kelechi Chikere with Jefferies.

（操作員說明）我們今天的第一個問題將來自 Kelechi Chikere 和 Jefferies。

Congrats on all the progress you've made over the quarter, and thank you for the comprehensive update. I guess on my first question, what gives you confidence that you'll be able to file in the U.S., EU and U.K.? And I guess how much risk is there associated with addressing some of those last remaining issues that are the gating steps to those filings? Any color there would be extremely helpful.

祝賀您在本季度取得的所有進展，並感謝您的全面更新。我想關於我的第一個問題，是什麼讓您有信心在美國、歐盟和英國提交申請？我猜想解決一些最後剩下的問題，這些問題是這些文件的門控步驟，有多少風險？那裡的任何顏色都會非常有幫助。

Yes. I think the risk reduction is dramatic. I think that it's a matter of now mechanics of getting all the data -- final data assembled and submitted. And it's -- we're talking weeks here. We're not talking months. So I'm not worried about the future submissions.

是的。我認為風險降低是顯著的。我認為現在是獲取所有數據的機制問題——最終數據的組裝和提交。這是 - 我們在這裡談論幾週。我們不是在談論幾個月。所以我不擔心未來的提交。

Got it. So you believe that at least the time lines that you've put forth, you'll be able to reach those. Is that more or less correct?

知道了。所以你相信至少你提出的時間線，你將能夠達到那些。這或多或少是正確的嗎？

I do. This is a very big transformation -- transition of the company we filed. We've now filed with the regulatory agencies in 3 countries, and we've got a complete filing package for those we are finishing the additional requirements in the various countries that I mentioned. We've listed dates that we plan on making with a lot of confidence.

我願意。這是一個非常大的轉變——我們提交的公司的轉變。我們現在已經向 3 個國家/地區的監管機構提交了申請，我們已經為那些我們正在完成我提到的各個國家/地區的額外要求的人提供了完整的申請包。我們已經列出了我們非常有信心計劃制定的日期。

Got it. Got it. Perfect. And I guess my last question, what additional data do you need to generate and -- to file to support your booster strategy campaign? Does it make sense to -- is there even a possibility that you can include some of the data that we're seeing here in the EUA filings to the U.S., EU and U.K.?

知道了。知道了。完美的。我想我的最後一個問題是，您需要生成哪些額外的數據，以及 - 歸檔以支持您的助推器策略活動？這是否有意義——你是否有可能將我們在這裡看到的一些數據包含在向美國、歐盟和英國提交的 EUA 文件中？

Yes. So certainly, we've shared this data with some of those agencies informally. I think initially, we were planning to file with just the overall primary indication of better than (inaudible) of age for the primary vaccination. And this data will follow on for a subsequent variation. Hopefully, this data will be in even prior to beneficial BLA or MAA. I think we've done very good.

是的。當然，我們已經與其中一些機構非正式地共享了這些數據。我認為最初，我們計劃僅提交總體主要跡象，即初次接種疫苗的年齡優於（聽不清）年齡。這些數據將繼續用於後續變化。希望這些數據甚至早於有益的 BLA 或 MAA。我認為我們做得很好。

And our next question will come from Mayank Mamtani with B. Riley FBR.

我們的下一個問題將來自 Mayank Mamtani 和 B. Riley FBR。

Congrats on progress being made here. So if I may just ask a quick follow-up on the U.K. filing that seems to be taking a little longer than maybe that was anticipated. I'm just curious if the Com-COV2 data that is being worked upon also a mix-and-match vaccine data. I'm just curious if you have an update on that. And if that data set is playing any role with what is going on in the U.K.? And if you can comment on the CMC side, the first part of that question would be helpful, too.

祝賀這裡取得的進展。因此，如果我可以要求對英國提交的文件進行快速跟進，這似乎需要比預期更長的時間。我只是好奇正在研究的 Com-COV2 數據是否也是混合搭配的疫苗數據。我只是好奇你是否有更新。如果該數據集對英國正在發生的事情起到任何作用？如果您可以對 CMC 方面發表評論，那麼該問題的第一部分也會有所幫助。

Okay. Well, I'll take the clinical study portion of the question. So there are 2 studies that are being funded by the BTF and are being done by University of Oxford in Southampton. One of them is a heterologous vaccination study that you referenced, Com-COV2. And the other 1 is a boosting study where people receive 2 doses of other response vaccines that are being boosted by our vaccine, and that's the CoV-Boost study. Those data -- those studies are sponsored by ourselves or sponsored by the universities. And we understand the data will be very valuable and published in the September time frame, so look forward to that data as with yourselves.

好的。好吧，我會回答這個問題的臨床研究部分。因此，有 2 項研究由 BTF 資助，並由南安普敦的牛津大學進行。其中之一是您引用的異源疫苗接種研究 Com-COV2。另一項是加強研究，人們接受 2 劑由我們的疫苗加強的其他反應疫苗，這就是 CoV-Boost 研究。那些數據——那些研究是由我們自己贊助或由大學贊助的。我們知道這些數據將非常有價值，並會在 9 月的時間範圍內發布，因此請像你們自己一樣期待這些數據。

We've discussed this data with the U.K. regulators and they suggested it would be helpful, but I thought that our Phase to boost data in conjunction with our South Africa data, would really be desirable to include it in a labeled indication.

我們已經與英國監管機構討論了這些數據，他們認為這會有所幫助，但我認為我們的階段將數據與我們的南非數據結合起來，將其包含在標記的指示中確實是可取的。

Great. And maybe if I could ask a specific question on the boost data here. The headline number of 4x on both IgG spike and also the wild-type utilization, how do you see this compare relative to maybe what we have seen with mRNA? And then the IgG decay here in your kinetic seems quite steep. I'm just curious, Filip, how should we think about that? Is there anything with the platform? Or just we should be expecting this sort of decay at 6 months irrespective of mRNA or a protein-based vaccine?

偉大的。也許我可以在這裡就提升數據提出一個具體問題。 IgG 峰值和野生型利用率的 4 倍標題數字，相對於我們在 mRNA 上看到的情況，您如何看待這個比較？然後你的動力學中的 IgG 衰減似乎非常陡峭。我只是好奇，菲利普，我們應該怎麼想？平台有什麼東西嗎？或者只是我們應該在 6 個月時期待這種衰變，而不管 mRNA 或基於蛋白質的疫苗如何？

I guess a couple of thoughts, and Greg can jump in as well. I'm not sure that measuring the absolute value of either (inaudible) or IgG at 6 months is an indication of efficacy at that time point. I think we've seen that from some of the other sponsors who started before we did and have data in that regard.

我想有幾個想法，格雷格也可以加入。我不確定在 6 個月時測量（聽不清）或 IgG 的絕對值是否表明該時間點的療效。我認為我們已經從其他一些在我們之前開始並擁有這方面數據的讚助商那裡看到了這一點。

We certainly haven't seen any decay in the Kaplan-Meier curves that I showed you, although clearly, that was only for the first 90, 100 days or so. I guess the other thing is that assays matter in different kind of assays measure different things. And finally, I would say it's not only the quantity of the antibody we induce but also the quality. And you saw from the data we showed was a functional H2 inhibition results that our antibody is able to really cross neutralize variants. Probably cross neutralize isn't the right word, to be able to block the functional interaction between Spike in ACE2.

我們當然沒有看到我向您展示的 Kaplan-Meier 曲線有任何衰減，儘管很明顯，這只是前 90 天、100 天左右的時間。我想另一件事是，在不同類型的化驗中，化驗很重要，測量不同的東西。最後，我想說這不僅是我們誘導的抗體的數量，還有質量。您從我們展示的數據中看到，我們的抗體能夠真正交叉中和變體，這是一個功能性 H2 抑制結果。可能交叉中和不是正確的詞，能夠阻止 ACE2 中 Spike 之間的功能交互。

So much like we saw with the influenza study, where we had good cross protection against drifted strains. I think we're seeing the same thing. This is a combination of the absolute titers you achieved and how good your antibody levels are. And I guess the other point is that these titers, if we hit titers of 200,000 like we demonstrated here, that's going to take a very long time for that to decay, and we have a much better chance of spreading in binding and protection because of the boost data and the maturation of immune response. Greg, do you want to say anything?

就像我們在流感研究中看到的那樣，我們對漂移的菌株有很好的交叉保護。我想我們看到的是同一件事。這是您達到的絕對滴度和您的抗體水平有多好的組合。我想另一點是這些滴度，如果我們像我們在這裡展示的那樣達到 200,000 的滴度，那將需要很長時間才能衰減，我們有更好的機會在結合和保護方面傳播，因為增強數據和免疫反應的成熟。格雷格，你想說什麼嗎？

That's good. Thank you.

那挺好的。謝謝你。

Awesome. And my final question on manufacturing, maybe Stan, are you able to comment on sort of what might be your monthly run rate, say, for July or anything on the doses that you may have stockpiled or even like the shelf life because I think folks are concerned that this bureaucracy of getting -- just getting into the market might be impacting what doses you may have already sitting on the shelf and not getting to people who can benefit from that?

驚人的。我最後一個關於製造業的問題，也許是斯坦，你能評論一下你的月度運行率，比如說，七月，或者你可能儲存的劑量，甚至喜歡保質期，因為我認為是否擔心這種官僚作風 - 只是進入市場可能會影響您可能已經坐在貨架上的劑量，而不是讓那些可以從中受益的人？

Yes. I think we're certainly working to make sure that we don't run into a shelf life problem of product being made. We have been successful in extending dating from 6 months to 9 months on a variety of our in-process work. Our expectation is that's not going to be an issue. We expect a fairly rapid licensure, and we expect to be able to use the product we make -- that we're scaling up right now.

是的。我認為我們肯定在努力確保我們不會遇到正在生產的產品的保質期問題。我們已經成功地將各種在製品的日期從 6 個月延長到 9 個月。我們的期望是這不會成為問題。我們希望獲得相當快的許可，並且我們希望能夠使用我們製造的產品——我們現在正在擴大規模。

We're scaling up globally to this rate of 100 million doses by the end of next month. And so you can figure out what that rate is to get to that point and then from 100 million to 150 million. But our -- until the product is filled, we don't have to worry about dating because the drug substance, the antigen itself is frozen. So that's all on the shelf. We've got many tens of millions of doses they're already ready to go. And by the end of August when we expect to begin shipping, being able to ship, we'll have -- globally will have probably over 100 million doses that we're able to ship. So we're work cooking on that issue. I mean it's going well.

到下月底，我們將在全球範圍內擴大到 1 億劑的這一速度。因此，您可以計算出達到該點的速率，然後從 1 億到 1.5 億。但是我們的——在產品被填充之前，我們不必擔心約會，因為原料藥，抗原本身是冷凍的。所以這一切都在架子上。我們已經準備好使用數千萬劑。到 8 月底，當我們預計開始發貨，能夠發貨時，我們將擁有 - 全球可能有超過 1 億劑我們能夠發貨。所以我們正在努力解決這個問題。我的意思是進展順利。

Our next question will come from Charles Duncan with Cantor Fitzgerald.

我們的下一個問題將來自查爾斯·鄧肯和康托·菲茨杰拉德。

I had kind of a broader question to start with, and that is regarding an annual boosting campaign. I guess I'm wondering if you could lay out how you think that would look and what you think the strongest source of competitive advantages that you may have? Is it in distribution? Or is it efficacy or tolerability or an ability for your vaccine to work nicely in the sandbox, if you will, with other vaccines such as influenza?

我有一個更廣泛的問題要開始，那就是關於年度推廣活動。我想我想知道您是否可以列出您認為的外觀以及您認為您可能擁有的最強大的競爭優勢來源？是在分發嗎？還是您的疫苗在沙盒中與其他疫苗（如流感）很好地協同工作的有效性、耐受性或能力？

Well, maybe I could add to that from the medical side. And like Stan said, pretty much all of the above. I think that we'll see as additional data emerges what the exact reaction profile of various vaccines are when they're given either a homologous boosting or heterologous boosting. And I think we'll have an advantage there. I think we've demonstrated that when we boost with our vaccine, we get very broad protection against all the brands we've tested it against. To be clear, I mean broadly immune response against all the variants you've tested against. So I think we're in good shape there as well. I suspect that as we go forward, we're going to have additional data, which is going to speak to the pathology of our vaccine and how long we can use it in the shelf life and so forth.

好吧，也許我可以從醫學方面補充一下。就像 Stan 說的，幾乎所有這些。我認為隨著更多數據的出現，我們將看到各種疫苗在接受同源加強或異源加強時的確切反應概況。而且我認為我們在那裡會有優勢。我認為我們已經證明，當我們用我們的疫苗加強免疫時，我們會得到非常廣泛的保護來對抗我們測試過的所有品牌。需要明確的是，我的意思是針對您測試過的所有變體的廣泛免疫反應。所以我認為我們在那裡的狀態也很好。我懷疑隨著我們的前進，我們將獲得更多數據，這將說明我們疫苗的病理學以及我們可以在保質期內使用多長時間等等。

Yes. I would just add, Charles, that there's a variety of factors here. And I think you heard in the presentation and the data that was presented today, that we're confident in the benefit and value of our boost strategy. But it really remains some additional data to be collected globally on what that policy position -- our global health policy position is going to be on Boost and what the time frame is for that.

是的。我只想補充一點，查爾斯，這裡有很多因素。而且我認為您在演示文稿和今天提供的數據中聽到，我們對我們提升戰略的好處和價值充滿信心。但它確實仍然需要在全球範圍內收集一些關於該政策立場的額外數據——我們的全球衛生政策立場將是關於 Boost 的，以及為此的時間框架。

So we're obviously collecting all the information relative to the data we had -- we're looking at the data from the other manufacturers. And certainly, we're in communication in the U.S. and globally about what that health care policy will be to support a boost strategy. And I think the data is suggesting that we're prepared for whatever that might be.

因此，我們顯然正在收集與我們擁有的數據相關的所有信息——我們正在查看來自其他製造商的數據。當然，我們正在美國和全球範圍內就支持促進戰略的醫療保健政策進行溝通。而且我認為數據表明我們已經為可能發生的一切做好了準備。

Could you imagine a 6-month boost or 12 months or annual boost?

您能想像 6 個月的提升或 12 個月或每年的提升嗎？

Yes. I think we're -- the data that was shown was a 6-month homologous boost data. I think Filip has talked about, we're going to be running a clinical trial in the fall is going to be looking at heterologous boost. And so we see significant value in a 6-month boost strategy as confirmed by the data. But we'll have to wait to see what the likes of ACIP and others will say in regard to that.

是的。我認為我們是 - 顯示的數據是 6 個月的同源提升數據。我認為 Filip 已經談到，我們將在秋季進行一項臨床試驗，以研究異源性增強。因此，正如數據所證實的那樣，我們認為 6 個月的提振策略具有重要價值。但我們將不得不等待，看看 ACIP 和其他人會對此發表什麼看法。

Okay. And then quickly going on to the MHRA meeting that you -- I think you mentioned later this month or next month. What is the specific question that you're looking to get out of MHRA? Or is it a checkup meeting prior to filing an application for -- or finishing the application for approval in the U.K.?

好的。然後快速進入您在本月晚些時候或下個月提到的 MHRA 會議。您希望擺脫 MHRA 的具體問題是什麼？還是在提交申請或完成在英國的批准申請之前的檢查會議？

Yes. This is -- this -- we hope would be the final meeting where we would have the submission after that. We're looking at the final questions that they come up with and leading to a filing in September.

是的。這就是——這——我們希望這將是最後一次會議，在那之後我們將提交提交。我們正在研究他們提出的最終問題，並在 9 月份提交申請。

Last question regarding influenza. I'm quite interested in seeing that move forward. I think it may be interesting to see a combination vaccine. And I guess I'm wondering when you consider the results that you have with the quadrivalent vaccine, what do you think was the driver of the influenza or the response? Was it Matrix-M? And could you speculate on what the response might look like when you combine with 2373 with NanoFlu?

最後一個關於流感的問題。我對看到這種進展非常感興趣。我認為看到聯合疫苗可能會很有趣。我想我想知道，當您考慮使用四價疫苗獲得的結果時，您認為流感的驅動因素或反應是什麼？是Matrix-M嗎？您能推測一下當您將 2373 與 NanoFlu 結合使用時會出現什麼反應？

Yes. This is Greg. I mean I just -- I think we have 2 sets of data now. So 1 is a very efficacious COVID vaccine with Matrix-M. And previously, as you know, we had really good success in older adults with our NanoFlu vaccine.

是的。這是格雷格。我的意思是——我認為我們現在有兩組數據。所以 1 是一種非常有效的帶有 Matrix-M 的 COVID 疫苗。如您所知，以前，我們的 NanoFlu 疫苗在老年人中取得了非常好的成功。

In this trial, this is a licensed vaccine given during the administration. And I think it showed to us that you could give a very good flu response and COVID response simultaneously. So we're looking forward to -- I think we're staying with our expectation as this fall, we'll be starting our combination flu COVID vaccine with Matrix-M. And we know Matrix-M has some really good future that creates a better quality and quantity of immune response.

在這項試驗中，這是在給藥期間給予的許可疫苗。我認為這向我們表明，你可以同時對流感和 COVID 做出很好的反應。因此，我們期待——我認為我們將保持我們的期望，因為今年秋天，我們將開始使用 Matrix-M 聯合流感 COVID 疫苗。我們知道 Matrix-M 有一些非常好的未來，可以創造更好的質量和數量的免疫反應。

I think that COVID has really proven the technology can be very powerful for protection against these respiratory vaccines. And I think flu, there has been the gap improving immune response, improving the efficacy with flu would be our expectation with this combo vaccine. So we're very excited to get that program into the clinic, and I expected that as we've said, I think that sometime this fall, we'll enroll our first subject in the combo trial.

我認為 COVID 確實證明了該技術可以非常有效地預防這些呼吸道疫苗。我認為流感，在提高免疫反應方面存在差距，提高流感的療效將是我們對這種組合疫苗的期望。因此，我們很高興將該計劃納入臨床，我預計正如我們所說，我認為今年秋天的某個時候，我們將在組合試驗中招募我們的第一個受試者。

And our next question will come from Vernon Bernardino with H.C. Wainwright.

我們的下一個問題將來自 Vernon Bernardino 和 H.C.溫賴特。

Congrats on the tremendous progress. I know it's been a long trip and I've been there with you and reading all the way. I know you just announced the submission for EUA, India, Indonesia and the Philippines. But can you give us an idea how long the regulatory process takes in those countries? And do you -- can you provide any insight in how many doses have been already distributed by others and other vaccines in those geographies and perhaps by the time 2373 becomes available in India, Indonesia and the Philippines?

祝賀取得了巨大的進步。我知道這是一次漫長的旅行，我一直和你在一起，一路看書。我知道你們剛剛宣布提交 EUA、印度、印度尼西亞和菲律賓。但是你能告訴我們這些國家的監管過程需要多長時間嗎？您能否提供有關這些地區的其他疫苗和其他疫苗已經分發了多少劑量的任何見解，也許到 2373 在印度、印度尼西亞和菲律賓上市時？

So I can speak to Indonesia. I think that they have had about 70 million doses distributed to date. A lot of those vaccine doses are for the Sinopharm, which is the inactivated vaccine and countries have expressed real interest in trying to have a booster with a vaccine like ours. So we did -- we have been approached by their government or at least our partner, Serum, was approached by Indonesia because of their extremely difficult situation they're having with the delta virus vaccine.

所以我可以和印度尼西亞談談。我認為到目前為止，他們已經分發了大約 7000 萬劑疫苗。其中很多疫苗劑量是用於國藥集團的，這是一種滅活疫苗，各國已經表示真正有興趣嘗試用我們的疫苗進行加強免疫。所以我們做到了——他們的政府已經與我們接洽，或者至少我們的合作夥伴 Serum 與印度尼西亞接洽，因為他們在使用 delta 病毒疫苗時遇到了極其困難的情況。

And I guess when I looked at the data we had today with boosting, it was very encouraging to see how good our immune response was with delta. And we can't predict the timing of these regulatory interactions very easily. We're hoping that something fairly soon could happen. But right now, we just don't have a prediction for the timing of their actions.

而且我想當我查看我們今天的增強數據時，看到我們的免疫反應對 delta 有多好是非常令人鼓舞的。而且我們不能很容易地預測這些監管相互作用的時間。我們希望很快就會發生一些事情。但現在，我們只是無法預測他們行動的時間。

Okay. And as a follow-up to that, I know that you're going to manufacture 350 million doses and SII will manufacture the balance of the 1.1 billion. How much of those doses will be going to 3 countries?

好的。作為後續行動，我知道你們將生產 3.5 億劑，而 SII 將生產剩下的 11 億劑。這些劑量中有多少將流向 3 個國家？

Yes. So we don't -- so COVAX controls -- Gavi controls it, Gavi and UNICEF. So we don't have -- currently, we don't know the order in which they want to provide doses for through the COVAX Facility.

是的。所以我們不-- 所以COVAX 控制-- Gavi 控制它，Gavi 和UNICEF。所以我們沒有 - 目前，我們不知道他們希望通過 COVAX 設施提供劑量的順序。

And our next question will come from Eric Joseph with JPMorgan.

我們的下一個問題將來自摩根大通的 Eric Joseph。

I guess with respect to the equity filings with EMA and MHRA can you -- I'm sorry if I missed it, but can you speak to what extent the submission packages or requirements differ from those already submitted with Serum Institute for India, Indonesia and the Philippines? Or I'm just curious to know whether you're seeing European regulators move the goalpost at all, given that it's kind of taken this long to complete those submissions?

我想關於向 EMA 和 MHRA 提交的股權申請，你能不能——如果我錯過了，我很抱歉，但你能說一下提交包或要求與已經提交給印度、印度尼西亞和血清研究所的文件有多大不同嗎？菲律賓人？或者我只是想知道您是否看到歐洲監管機構完全改變了目標，因為完成這些提交需要這麼長時間？

And then, Stan, you sound fairly confident on the authorization path remaining opening in the U.S. following the approval -- potential approval of the mRNA vaccines. I'm curious to know if there's any other feedback specifically from the agency that gets you comfortable with that windows getting open through the fourth quarter. And whether or not it does, we'll be curious to get a sense of how to think about time lines to a BLA filing with 2373?

然後，斯坦，你聽起來相當有信心在獲得批准後在美國仍然開放的授權路徑——mRNA 疫苗的潛在批准。我很想知道該機構是否有任何其他反饋，讓你對第四季度開放的窗戶感到滿意。無論是否這樣做，我們都會很好奇如何考慮如何考慮向 2373 提交 BLA 文件的時間線？

Yes. So a couple questions there, but my confidence in my statement is generated by news articles. Peter Marks and before that -- before I read that quote, I would have said we can't predict whether the EUA -- it's been a question mark for a bunch, whether the EUAs going to remain open. And when Peter Marks said that it will remain open in particular because we want to get a protein-based COVID vaccine through the system. My confidence went up a lot. And so that's what I base it on.

是的。所以有幾個問題，但我對我的陳述的信心是由新聞文章產生的。 Peter Marks 和在此之前——在我讀到那句話之前，我會說我們無法預測 EUA 是否——對於一群人來說，這是一個問號，EUA 是否會保持開放。當彼得馬克斯說它將保持開放時，特別是因為我們希望通過該系統獲得基於蛋白質的 COVID 疫苗。我的信心上升了很多。這就是我的基礎。

On the regulatory issues. So every -- so we have made products in different plants and use it in different clinical trials. And what is the only difference between what we're filing with everybody else and what we're intending to file with the MHRA and EMA is we're finishing up some comparability work between lots that needs to be done. And those -- I think the actual studies are done, and they did as we put together, and that's what's going to take, getting the data put together and submit it to the MHRA. And so it's -- I have a great deal of confidence that, that package will go into them on the timetable we just talked about.

關於監管問題。所以每一個——所以我們在不同的工廠生產產品，並在不同的臨床試驗中使用它。我們向其他人提交的文件與我們打算向 MHRA 和 EMA 提交的文件之間的唯一區別是，我們正在完成一些需要完成的批次之間的可比性工作。而那些——我認為實際的研究已經完成，他們按照我們匯總的方式進行，這就是將要採取的措施，將數據匯總並提交給 MHRA。所以它 - 我非常有信心，該包將按照我們剛剛談到的時間表進入他們。

How are you planning to update investors, I guess, as it relates to those package submissions?

我猜你打算如何更新投資者，因為它與那些包裹提交有關？

Well, I think when -- obviously, when we get an approval, you'll get a press release. And I think when we file with major agencies like MHRA and EMA will announce that in the press release.

嗯，我想當——顯然，當我們獲得批准時，你會得到一份新聞稿。我認為，當我們向 MHRA 和 EMA 等主要機構提交申請時，會在新聞稿中宣布這一點。

Okay. And maybe just 1 follow-up, if I could. I'm just trying to understand -- better understand some of the language in the most recent filing here. As it relates to your agreement with the U.S. government saying that it would like to see FDA alignment on your analytical methods before conducting additional U.S. manufacturing. And I guess how do I understand that? Is that suggest some kind of optimizational approval before continued U.S. production? And would it have some variants...

好的。如果可以的話，也許只有 1 次跟進。我只是想理解——更好地理解這裡最近提交的文件中的一些語言。因為它與您與美國政府的協議有關，表示希望在進行額外的美國製造之前看到 FDA 與您的分析方法保持一致。我想我怎麼理解？這是否意味著在繼續美國生產之前進行某種優化批准？會不會有一些變種...

That's sort of the source of some of the delay with the FDA as we have this USG, the U.S. government, that is our partner in developing this vaccine, and they are the gate to our submitting to the FDA. So there has to be some negotiation with U.S. government and does the validation activities meet their standards and then we take it to the FDA. And there's always a time lag with the FDA these days. And so -- It's -- but we need -- but they want us to get FDA concurrence that our assay is fully validated, and that's what the time difference is.

這在某種程度上是 FDA 延誤的原因，因為我們有這個 USG，美國政府，這是我們開發這種疫苗的合作夥伴，他們是我們向 FDA 提交的大門。因此，必須與美國政府進行一些談判，驗證活動是否符合他們的標準，然後我們將其提交給 FDA。這些天，FDA 總是有時間滯後。所以 - 這是 - 但我們需要 - 但他們希望我們得到 FDA 的同意，我們的檢測已經完全驗證，這就是時差。

Okay. Would this have any impact on the originally planned delivery of the 100 million doses under the original warp speed agreements now that you are originally expecting delivery in the first half of '22?

好的。既然您最初預計在 22 年上半年交付，這會對最初計劃在原始曲速協議下交付 1 億劑疫苗有什麼影響嗎？

Sure, it does. Because the original timetable calls for starting to deliver those doses in the fourth quarter and through the second quarter of next year. And I think that probably we won't get any doses shipped in the fourth quarter, and it will just push it back to the first and second quarter. We've stockpiled those doses. So it's -- they will come in a rush once we get the FDA approval.

當然，確實如此。因為最初的時間表要求在第四季度和明年第二季度開始提供這些劑量。而且我認為我們可能不會在第四季度發貨，它只會將其推遲到第一季度和第二季度。我們已經儲存了這些劑量。因此，一旦我們獲得 FDA 的批准，他們就會匆忙趕來。

And this will conclude our question-and-answer session. I'd like to turn the conference back over to Stan for any closing remarks.

這將結束我們的問答環節。我想把會議轉回給 Stan 做任何閉幕詞。

Yes. This has been a huge transition quarter for the company. I mean getting regulatory submissions is huge. We're on the verge of product approval. We believe we have additional -- we've demonstrated additional demand for the product and with the EU filing, and we've got great data that shows our vaccine is effective against the various strains. And so we're very optimistic and we look forward to reporting to you next quarter. Thank you.

是的。對於公司來說，這是一個巨大的過渡季度。我的意思是獲得監管提交是巨大的。我們即將獲得產品批准。我們相信我們還有額外的需求——我們已經證明了對該產品的額外需求並提交了歐盟文件，並且我們有大量數據表明我們的疫苗對各種毒株有效。因此，我們非常樂觀，我們期待在下個季度向您報告。謝謝你。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.

會議現已結束。感謝您參加今天的演講。你現在可以在這個時候斷開你的線路。