Novavax Inc (NVAX) 2021 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Third Quarter 2021 Financial Results and Operational Highlights Conference Call.

女士們，先生們，感謝您的支持，並歡迎參加 Novavax 2021 年第三季度財務業績和運營亮點電話會議。

(Operator Instructions) Please be advised that today's conference is being recorded.

（操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, Silvia Taylor.

我現在想把會議交給你今天的演講者西爾維婭·泰勒。

You may begin.

你可以開始了。

Thanks very much.

非常感謝。

Good afternoon, everyone, and thank you all for joining us today for our call to discuss our third quarter 2021 operational highlights and financial results.

大家下午好，感謝大家今天加入我們的電話，討論我們 2021 年第三季度的運營亮點和財務業績。

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.

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。

Joining me today is Stan Erck, President and CEO, who will discuss regulatory updates; additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer, will discuss our manufacturing and supply updates and the market opportunity for our COVID-19 vaccine; and Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical developments.

今天加入我的是總裁兼首席執行官 Stan Erck，他將討論監管更新；此外，首席商務官兼首席商務官 John Trizzino 將討論我們的製造和供應更新以及我們 COVID-19 疫苗的市場機會；首席醫療官 Filip Dubovsky 博士將討論我們的臨床發展。

Jim Kelly, Chief Financial Officer and Treasurer, will also join today's call to overview our financial results for the third quarter.

首席財務官兼財務主管吉姆·凱利（Jim Kelly）也將參加今天的電話會議，概述我們第三季度的財務業績。

Additionally, Dr. Greg Glenn, President of R&D, will be available for the Q&A section at the end of today's call.

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 expectations and beliefs.

在開始準備發言之前，我需要提醒您，我們將在本次電話會議期間根據我們當前的期望和信念做出前瞻性陳述。

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.

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、未來監管文件和行動的時間安排以及其他預期里程碑的預期，都是前瞻性陳述。

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.

Novavax 告誡說，這些前瞻性陳述受到眾多假設風險和不確定性的影響，這些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。

We encourage you to consult the risk factors discussed in our SEC filings for additional detail.

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'd now like to hand the call over to Stan.

我現在想把電話交給斯坦。

For those of you following the accompanying slides, please turn to Slide 3. Stan?

對於那些跟隨隨附幻燈片的人，請轉到幻燈片 3。斯坦？

Thank you, Silvia, and thanks to everyone for joining us today.

謝謝你，Silvia，也感謝大家今天加入我們。

I'm excited to be here today following an incredibly exciting week for Novavax.

在為 Novavax 度過了令人難以置信的激動人心的一周之後，我很高興今天來到這裡。

This past week, we reached a critical milestone.

過去一周，我們達到了一個關鍵的里程碑。

We received our first authorization for our COVID-19 vaccine in India -- Indonesia, sorry.

我們在印度 - 印度尼西亞獲得了 COVID-19 疫苗的首次授權，抱歉。

This milestone marks Novavax' first-ever approval of our protein-based COVID-19 vaccine.

這一里程碑標誌著 Novavax 首次批准我們基於蛋白質的 COVID-19 疫苗。

This approval is based upon demonstrated strong efficacy and a favorable safety profile and represents a significant point in our transformation into a global commercial vaccine company.

該批准基於已證明的強大功效和良好的安全性，代表了我們向全球商業疫苗公司轉型的重要一步。

In addition to receiving our first authorization for 2373, we executed on our regulatory strategy in other global markets, with 9 submissions now filed with regulatory agencies around the world.

除了獲得我們對 2373 的首次授權外，我們還在其他全球市場執行了我們的監管戰略，現已向全球監管機構提交了 9 份申請。

I would like to acknowledge the tremendous efforts made by the entire Novavax team, express my gratitude for our partners and clinical trial sites for their continued support of our mission and importantly, thank each of our clinical trial participants for their vital contributions made during an unprecedented global pandemic.

我要感謝整個 Novavax 團隊所做的巨大努力，感謝我們的合作夥伴和臨床試驗站點對我們使命的持續支持，更重要的是，感謝我們的每一位臨床試驗參與者在前所未有的過程中做出的重要貢獻全球大流行。

Only through these collaborative efforts were we able to achieve the significant progress.

只有通過這些協作努力，我們才能取得重大進展。

On today's call, I will discuss these regulatory developments in more detail as well as our key upcoming milestones.

在今天的電話會議上，我將更詳細地討論這些監管發展以及我們即將到來的關鍵里程碑。

Other members of our team will discuss manufacturing and supply updates, updates on clinical developments and financial results for the quarter.

我們團隊的其他成員將討論本季度的製造和供應更新、臨床開發更新和財務業績。

With that, I'd like to begin today's call by discussing the tremendous progress we've made to date on the regulatory front.

有了這個，我想通過討論我們迄今為止在監管方面取得的巨大進展來開始今天的電話會議。

Please turn to Slide 4. We now have our first regulatory authorization in hand with the granting of Emergency Use Authorization for 2373 by Indonesia.

請轉到幻燈片 4。隨著印度尼西亞授予 2373 的緊急使用授權，我們現在有了我們的第一個監管授權。

Our COVID-19 vaccine will be manufactured and marketed by Serum Institute of India under the brand name of COVOVAX.

我們的 COVID-19 疫苗將由印度血清研究所以 COVOVAX 品牌生產和銷售。

The first authorization of our COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which is the fourth most populous nation on earth and continues to work to procure sufficient vaccine for its population.

我們 COVID-19 疫苗的首次授權體現了我們對全球公平獲取的承諾，並將滿足印度尼西亞的迫切需求，印度尼西亞是地球上人口第四多的國家，並將繼續努力為其人口採購足夠的疫苗。

We expect that initial shipments into Indonesia by Serum will begin imminently.

我們預計 Serum 將很快開始向印度尼西亞發貨。

Over the past week alone, we completed submissions to 6 regulatory agencies in the following markets: these include the U.K.'s MHRA, Australia's Therapeutic Goods Administration, Health Canada, New Zealand's Medsafe and the European Medicines Agency, or EMA, where we completed the submission of all documents required for regulatory review.

僅在過去一周，我們就完成了向以下市場的 6 個監管機構提交的申請：其中包括英國的 MHRA、澳大利亞的治療用品管理局、加拿大衛生部、新西蘭的 Medsafe 和歐洲藥品管理局（EMA），我們在那裡完成了提交監管審查所需的所有文件。

Additionally, today, we completed Novavax' rolling submission to the WHO for Emergency Use Listing of 2373.

此外，今天，我們完成了 Novavax 向世界衛生組織緊急使用清單 2373 的滾動提交。

Our regulatory packages have been harmonized across our filings, which initially leverage our manufacturing partnership with Serum Institute.

我們的監管包已經在我們的文件中進行了協調，這些文件最初利用了我們與 Serum Institute 的製造合作夥伴關係。

In the near future, we will supplement our submissions with information from additional facilities across our global supply chain and are confident that our clinical manufacturing data form a strong package for review by regulatory agencies.

在不久的將來，我們將用來自我們全球供應鏈中其他設施的信息來補充我們提交的信息，並相信我們的臨床製造數據會形成一個強有力的包，供監管機構審查。

All these regulatory packages are in addition to those we've previously announced for filings in India, in the Philippines and of course, Indonesia, where we are already approved.

所有這些監管方案都是我們之前宣布的在印度、菲律賓，當然還有我們已經獲得批准的印度尼西亞提交的文件的補充。

These filings and in particular, the WHO EUL listing, will enable our effort to provide doses for global equitable access.

這些文件，特別是 WHO EUL 清單，將使我們能夠努力為全球公平獲取提供劑量。

We remain diligent in our efforts to complete filings in additional geographies shortly.

我們將繼續努力盡快完成在其他地區的申請。

In the U.S., we expect to submit our complete regulatory package to the FDA before the end of this year.

在美國，我們希望在今年年底之前向 FDA 提交完整的監管包。

So we've made tremendous progress on the regulatory front.

因此，我們在監管方面取得了巨大進展。

We have harmonized all of our regulatory filing packages and submitted them to multiple agencies around the world, all to advance our shared goal of making our vaccine available as quickly and safely as possible to those in need.

我們已經統一了我們所有的監管文件包，並將它們提交給世界各地的多個機構，所有這些都是為了推進我們的共同目標，即盡可能快速、安全地為有需要的人提供我們的疫苗。

While we cannot predict how long regulatory agencies will take to approve these packages, we are prepared to work closely and diligently with all the regulatory authorities to facilitate approval.

雖然我們無法預測監管機構批准這些方案需要多長時間，但我們準備與所有監管機構密切合作，以促進批准。

I'd now like to turn it over to John, for updates across our global supply chain, 2373's anticipated role in the COVID-19 landscape and an overview of our supply commitments for 2373.

我現在想把它交給約翰，以了解我們全球供應鏈的最新情況、2373 在 COVID-19 領域的預期作用以及我們對 2373 的供應承諾的概述。

Thank you, Stan.

謝謝你，斯坦。

Moving to Slide 5. Today, we have a global infrastructure in place to support the manufacturing of 2373 with a supply chain of partners and Novavax-owned facilities spanning the world.

轉到幻燈片 5。今天，我們擁有一個全球基礎設施來支持 2373 的製造，其合作夥伴供應鍊和 Novavax 擁有的設施遍布全球。

This expansive global supply chain includes our partnership with Serum Institute, the world's largest vaccine manufacturer by volume; a state-of-the-art wholly owned manufacturing site in the Czech Republic, also known as Novavax CZ; and in Sweden, Novavax AB; manufacturing at established vaccine makers, including SK Bioscience in South Korea and Takeda in Japan; and additional manufacturing partners around the world that include Biofabri in Spain, FujiFilm in the U.S. and U.K., Mabion in Poland and the National Research Council's Biologics Manufacturing Center in Canada.

這條廣闊的全球供應鏈包括我們與全球產量最大的疫苗製造商 Serum Institute 的合作夥伴關係；捷克共和國最先進的全資製造基地，也稱為 Novavax CZ；在瑞典，Novavax AB；在老牌疫苗製造商生產，包括韓國的 SK Bioscience 和日本的武田；以及世界各地的其他製造合作夥伴，包括西班牙的 Biofabri、美國和英國的 FujiFilm、波蘭的 Mabion 和加拿大國家研究委員會的生物製品製造中心。

Over the third quarter, we executed a number of agreements to expand our supply chain and ready our global network for commercialization, and these include collaborating with our partner, Takeda, to support their anticipated annual manufacturing capacity of 250 million doses of 2373, expanding our partnership with Serum Institute to manufacture 2373 and entering into an agreement with Mabion for the large-scale production of 2373 through the year 2026.

在第三季度，我們執行了多項協議以擴展我們的供應鏈並為我們的全球網絡商業化做好準備，其中包括與我們的合作夥伴武田合作，以支持他們預計的 2.5 億劑 2373 的年製造能力，擴大我們的與 Serum Institute 合作生產 2373，並與 Mabion 達成協議，在 2026 年之前大規模生產 2373。

We have made significant progress in mobilizing our supply chain over recent months.

最近幾個月，我們在調動供應鏈方面取得了重大進展。

We are routinely producing high-quality product at commercial scale at multiple sites around the world.

我們經常在世界各地的多個地點以商業規模生產高質量的產品。

As of the end of the third quarter, we achieved our goal of a manufacturing capacity of 100 million doses per month.

截至第三季度末，我們實現了每月生產1億劑的目標。

Looking to the months ahead, we expect to achieve a manufacturing capacity of 150 million doses per month by the end of the fourth quarter, with the expectation that we will have a manufacturing capacity in excess of 2 billion annual doses in 2022, inclusive of capacity from our partner, Serum Institute.

展望未來幾個月，我們預計到第四季度末將實現每月1.5億劑的製造能力，預計到2022年我們將擁有超過20億劑的製造能力，包括產能來自我們的合作夥伴血清研究所。

This significant ramp-up in manufacturing will allow us to not only deliver on our current supply agreements but also support additional demand for our vaccine in 2022 and beyond.

製造業的這一顯著增長將使我們不僅能夠履行我們目前的供應協議，而且還能支持 2022 年及以後對我們疫苗的額外需求。

Now moving to Slide 6. In addition to dramatically increasing the number of available doses to immunize the world, we expect our vaccine will help address major obstacles during this pandemic and beyond, including global distribution challenges and vaccine hesitancy.

現在轉到幻燈片 6。除了大幅增加用於免疫世界的可用劑量之外，我們預計我們的疫苗將有助於解決這場大流行期間及以後的主要障礙，包括全球分銷挑戰和疫苗猶豫。

Storage at standard refrigeration temperatures allows our vaccine to use the existing vaccine supply chain and will increase access to hard-to-reach areas to improve vaccination rates across the globe.

在標準冷藏溫度下儲存使我們的疫苗能夠使用現有的疫苗供應鏈，並將增加對難以到達地區的訪問，以提高全球的疫苗接種率。

Recombinant protein vaccines are well understood and already in wide-spread use, having been used for decades.

重組蛋白疫苗廣為人知，並且已經廣泛使用，已經使用了幾十年。

And additionally, we have a robust clinical data package demonstrating our vaccine's favorable safety profile and strong immunogenicity and efficacy against multiple strains of the coronavirus, all of which drives confidence in Novavax' vaccine's ability to help protect against the disease.

此外，我們擁有強大的臨床數據包，證明我們的疫苗具有良好的安全性以及對多種冠狀病毒株的強大免疫原性和功效，所有這些都增強了人們對 Novavax 疫苗幫助預防該疾病的能力的信心。

Now turning to Slide 7. As you can see on this slide, we have several supply and licensing agreements in place to ensure the widespread distribution of our vaccine, maintaining the mindset that access to vaccines should have no borders.

現在轉到幻燈片 7。正如您在這張幻燈片上看到的，我們制定了幾項供應和許可協議，以確保我們的疫苗的廣泛分發，保持獲得疫苗應該沒有國界的心態。

Our vaccine network will support our supply commitments globally, including up to over 400 million doses of 2373 through bilateral supply agreements, including doses to the European Commission through our APA executed during the third quarter and our joint commitment with Serum Institute of 1.1 billion doses for the COVAX facility.

我們的疫苗網絡將支持我們在全球的供應承諾，包括通過雙邊供應協議提供多達 4 億劑 2373，包括通過我們在第三季度執行的 APA 向歐盟委員會提供的劑量，以及我們與血清研究所共同承諾的 11 億劑COVAX 設施。

In addition to supplying 2373 for primary vaccination, we expect the need for boosters will continue in the coming years, and we believe 2373 will play a very important role in this ongoing need.

除了提供 2373 用於初級疫苗接種外，我們預計未來幾年對加強劑的需求將繼續存在，我們相信 2373 將在這一持續需求中發揮非常重要的作用。

Over the coming months, we will be able to support supply to additional markets in need of boosters across high-, middle- and low-income countries.

在接下來的幾個月裡，我們將能夠支持向高收入、中等收入和低收入國家需要助推器的其他市場供應。

I'd now like to turn it over to Filip Dubovsky to discuss clinical developments across our pipeline during the third quarter.

我現在想把它交給 Filip Dubovsky 在第三季度討論我們管道的臨床發展。

Thanks, John.

謝謝，約翰。

Please turn to Slide 8. What's displayed here is the high-level 2373 clinical development plan.

請翻到幻燈片 8。這裡展示的是高水平的 2373 臨床開發計劃。

The safety, immunogenicity and efficacy of our vaccine is derived from these studies.

我們疫苗的安全性、免疫原性和有效性源自這些研究。

And all these studies are part of our common clinical regulatory package that's included in our harmonized regulatory filings.

所有這些研究都是我們共同的臨床監管包的一部分，包含在我們的統一監管文件中。

This data has been provided to regulatory agencies on an ongoing basis and this is currently being reviewed.

該數據已持續提供給監管機構，目前正在審查中。

Let's skip ahead to Slide 9. This slide highlights our 2 pivotal Phase III studies.

讓我們跳到幻燈片 9。這張幻燈片重點介紹了我們的 2 個關鍵的 III 期研究。

The bulk of our safety and efficacy data is derived from these studies.

我們的大部分安全性和有效性數據來自這些研究。

One remarkable feature of our vaccine is the consistent efficacy we've seen.

我們疫苗的一個顯著特點是我們已經看到了一致的功效。

The primary vaccine efficacy estimates are within 1 percentage point of each other, and that's despite the fact these studies were conducted at different times in different populations during a time when different variants emerged.

主要疫苗功效估計值彼此相差 1 個百分點以內，儘管事實上這些研究是在不同變體出現的不同時期在不同人群中進行的。

You can see a very high point estimate of efficacy, 96% to 100%, against match strains.

您可以看到針對匹配菌株的功效估計值非常高，從 96% 到 100%。

These are strains whose sequences are most similar to that included in the vaccine.

這些菌株的序列與疫苗中的序列最相似。

Additionally, the vaccine works well against variance, not only against alpha, but as we have detailed earlier in our U.S. Phase III study, against all variants that circulated at that time.

此外，該疫苗可以很好地對抗變異，不僅對抗 alpha，而且正如我們之前在美國 III 期研究中詳述的那樣，對抗當時流通的所有變體。

Importantly, we have complete protection against severe disease, hospitalization and deaths in all of our efficacy studies, and that includes, again, severe disease caused by variants.

重要的是，在我們所有的功效研究中，我們對嚴重疾病、住院和死亡都有完全的保護，這也包括由變異引起的嚴重疾病。

In the larger U.S. study, our vaccine efficacy was 100% against severe disease.

在更大規模的美國研究中，我們的疫苗對嚴重疾病的療效為 100%。

And in the smaller U.K. and South African studies, although we couldn't calculate an efficacy because of the low number of cases, all the severe cases were in placebo group.

在較小的英國和南非研究中，雖然由於病例數少，我們無法計算療效，但所有嚴重病例都在安慰劑組。

Finally, our efficacy in high-risk populations, such as the elderly and people with comorbid conditions, is almost identical to that of their overall population.

最後，我們在高危人群（例如老年人和有合併症的人）中的療效幾乎與他們的總體人群相同。

So now let's skip forward to Slide 10, talk about our progress in pediatrics.

所以現在讓我們跳到幻燈片 10，談談我們在兒科方面的進展。

We expanded our U.S. Phase III study to include over 2,200 12- to 17-year-olds.

我們擴大了我們的美國 III 期研究，包括 2,200 多名 12 至 17 歲的兒童。

All the primary vaccination series have been delivered.

所有初級疫苗接種系列均已交付。

And in fact, all the children have been crossed over and safety and efficacy data collection is ongoing.

事實上，所有的孩子都已經過關，安全性和有效性數據的收集正在進行中。

We expect to have a regulatory package available for global submission in the first quarter.

我們預計第一季度將有一個可用於全球提交的監管包。

The subsequent pediatric clinical development plan has been agreed to by the FDA, MHRA and EMA and the studies will be initiated after this adolescent study reads out.

隨後的兒科臨床開發計劃已獲得 FDA、MHRA 和 EMA 的同意，研究將在這項青少年研究宣讀後啟動。

Okay, let's move on to Slide 11 and talk about boosting.

好的，讓我們繼續討論幻燈片 11 並討論提升。

In our Phase II study in the U.S. and Australia, we boosted select cohorts at 6 months and at 12 months and the 12-month doses are just finishing up now.

在我們在美國和澳大利亞進行的 II 期研究中，我們在 6 個月和 12 個月時增加了選定的隊列，而 12 個月的劑量現在剛剛結束。

We've previously disclosed that a single dose at 6 month can increase wild-type neutralization as well as IgG antibody levels more than fourfold from their peak after receiving 2 doses.

我們之前曾披露，在接受 2 劑後，6 個月時的單劑可將野生型中和以及 IgG 抗體水平從峰值增加四倍以上。

However, more importantly, using a stringent human ACE2 inhibition assay, this measures functional antibodies, we demonstrated that our vaccine can boost responses to alpha, beta and delta 6.6 to 10.8 fold over their peak.

然而，更重要的是，使用嚴格的人類 ACE2 抑制試驗來測量功能性抗體，我們證明我們的疫苗可以將對 alpha、beta 和 delta 的反應提高 6.6 至 10.8 倍，超過其峰值。

We believe this is a strength of our vaccine, likely linked to our adjuvant system.

我們相信這是我們疫苗的優勢，可能與我們的佐劑系統有關。

We saw excellent protection in the Phase III studies against variants.

我們在 III 期研究中看到了針對變體的出色保護。

And recently, Professor Snape from Oxford presented data that demonstrated that 2373 has a specific strength in inducing cross-variant neutralizing responses.

最近，來自牛津大學的 Snape 教授提供的數據表明，2373 在誘導交叉變異中和反應方面具有特定的優勢。

In our South Africa Phase II study, we boosted all participants who initially received 2 doses of vaccine with a third dose at 6 months, and that safety data is maturing.

在我們的南非 II 期研究中，我們對所有最初接受 2 劑疫苗的參與者在 6 個月時接種了第三劑疫苗，並且安全性數據正在成熟。

The emergency data from the U.S., Australia, along with the safety data from our South Africa study will serve as the basis of our regulatory filings supporting our boosting indication.

來自美國、澳大利亞的緊急數據以及來自我們南非研究的安全數據將作為我們的監管文件的基礎，以支持我們的增強適應症。

Finally, let's move to Slide 12, and I want to update you on the progress of our Australia NanoFlu, our 2373 combination study.

最後，讓我們轉到幻燈片 12，我想向您介紹我們的澳大利亞 NanoFlu（我們的 2373 組合研究）的最新進展。

As you may know, we recently published an NanoFlu Phase III study this quarter in Lancet ID and the study met its primary endpoints, and we've been given a regulatory pathway for licensure by the FDA.

如您所知，我們最近在本季度在 Lancet ID 上發表了 NanoFlu III 期研究，該研究達到了其主要終點，並且我們已獲得 FDA 許可的監管途徑。

The current study, the combination study, was designed to define the dosage levels in vaccination schedule for our quadrivalent flu HA antigen combined with our COVID antigen.

目前的研究，即聯合研究，旨在確定我們的四價流感 HA 抗原與我們的 COVID 抗原相結合的疫苗接種計劃中的劑量水平。

Enrollment is complete.

註冊完成。

All the first doses have been delivered and the second doses are being currently administered.

所有第一劑已交付，第二劑目前正在給藥。

We believe that much like flu, COVID will continue to circulate.

我們相信，就像流感一樣，COVID 將繼續傳播。

Our flu and COVID vaccine share immunologic attributes that make the vaccine attractive in providing protection against drifted flu strains as well as COVID variants.

我們的流感和 COVID 疫苗具有共同的免疫特性，這使得疫苗在提供針對漂移的流感病毒株和 COVID 變體的保護方面具有吸引力。

This data will be available in the first half of 2022.

該數據將於 2022 年上半年提供。

I'd like to now turn it over to Jim to provide an overview of our financial results for the third quarter.

我現在想把它交給吉姆來概述我們第三季度的財務業績。

Jim?

吉姆?

Thank you, Filip.

謝謝你，菲利普。

I'd like to start by saying how happy I am to join the Novavax team at such an important moment and look forward to contributing to our rapid transition to becoming a global commercial company.

首先，我很高興能在如此重要的時刻加入 Novavax 團隊，並期待為我們快速過渡到成為一家全球商業公司做出貢獻。

This afternoon, we announced our financial results for the third quarter of 2021, and I'll provide you with a summary of the key highlights beginning on Slide 13.

今天下午，我們公佈了 2021 年第三季度的財務業績，我將為您提供從幻燈片 13 開始的主要亮點摘要。

Today, we reported total revenue for the third quarter of 2021 of $179 million and ended the period with $1.9 billion in cash.

今天，我們報告了 2021 年第三季度的總收入為 1.79 億美元，並以 19 億美元的現金結束了這一時期。

This means we are well capitalized as we advance towards the commercial launch of 2373.

這意味著我們在推進 2373 的商業發佈時資本充足。

Turning to our financial results on Slide 14, we compare our third quarter 2021 results through the third quarter of 2020.

轉向幻燈片 14 上的財務業績，我們比較了 2021 年第三季度到 2020 年第三季度的業績。

During the third quarter of 2021, we recorded a net loss of $322 million or $4.31 per share.

在 2021 年第三季度，我們錄得淨虧損 3.22 億美元或每股 4.31 美元。

This compares to a loss of $197 million or $3.21 per share in the prior year.

相比之下，去年虧損 1.97 億美元或每股 3.21 美元。

Our third quarter 2021 revenue of $179 million and 14% growth compares to $157 million in the prior year.

我們 2021 年第三季度的收入為 1.79 億美元，與去年的 1.57 億美元相比增長 14%。

Our total revenue consists of government contract revenue, grant revenue and royalty revenue.

我們的總收入包括政府合同收入、贈款收入和特許權使用費收入。

Government contract revenue of $98 million reflects our funding from the U.S. government under Operation Warp Speed, which increased by $55 million in the period as we saw an increase in our 2373 funded activities.

9800 萬美元的政府合同收入反映了我們在“曲速行動”下從美國政府獲得的資金，隨著我們看到 2373 項資助活動的增加，這一期間增加了 5500 萬美元。

Grant revenue of $41 million comes primarily from our CEPI funding agreement and fell by $73 million as that agreement is more oriented towards start-up activities, which are now coming to a close.

4100 萬美元的贈款收入主要來自我們的 CEPI 資助協議，但由於該協議更側重於現在即將結束的啟動活動，因此減少了 7300 萬美元。

Finally, royalty revenue of $40 million reflects the Novavax share of sales of our license partners.

最後，4000 萬美元的特許權使用費收入反映了 Novavax 在我們的許可合作夥伴的銷售額中所佔的份額。

In this case, SK Biosciences made sales of 2373 antigen component to the Korean government during the period.

在這種情況下，SK Biosciences在此期間向韓國政府出售了2373抗原成分。

Total expenses for the third quarter of 2021 were $486 million and are primarily weighted towards our R&D activities in support of 2373, both in total for the quarter, are the primary cause of the year-over-year growth.

2021 年第三季度的總支出為 4.86 億美元，主要用於我們支持 2373 的研發活動，這兩項在本季度總計是同比增長的主要原因。

Following an expected regulatory approval of our vaccine, certain types of expenses that have previously been expensed as R&D will be capitalized to inventory and expensed as cost of goods sold when product is delivered.

在我們的疫苗獲得監管部門的預期批准後，以前作為研發費用的某些類型的費用將資本化為庫存，並在產品交付時作為銷售商品的成本費用。

As noted earlier, we ended the third quarter with $1.9 billion in cash and cash equivalents as compared to just over $800 million at year-end 2020.

如前所述，我們在第三季度結束時擁有 19 億美元的現金和現金等價物，而 2020 年底時剛剛超過 8 億美元。

The primary sources of our increase in cash year-to-date are the $1.2 billion in payments received under advance purchase agreements and over $560 million from the sale of common stock in the first quarter.

今年迄今為止，我們現金增加的主要來源是根據預購協議收到的 12 億美元付款和第一季度出售普通股的超過 5.6 億美元。

I would now like to turn the call back to Stan to discuss our strategic priorities for the months to come.

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。

Thank you, Jim, and welcome on board.

謝謝你，吉姆，歡迎加入。

Please turn to Slide 15.

請轉到幻燈片 15。

It was a tremendous quarter for us at Novavax.

對我們 Novavax 來說，這是一個巨大的季度。

Behind the scenes, our over 1,300 employees worked tirelessly to prepare for the delivery of 2373 globally.

在幕後，我們的 1,300 多名員工孜孜不倦地為全球交付 2373 台做準備。

Over the coming months, obtaining regulatory authorization for our COVID-19 vaccine remains our top priority.

在接下來的幾個月裡，獲得 COVID-19 疫苗的監管授權仍然是我們的首要任務。

This involves continued collaboration and discussion with regulatory agencies with whom we've already completed submissions.

這涉及與我們已經完成提交的監管機構繼續合作和討論。

In other geographies, we will finalize our packages for filing.

在其他地區，我們將最終確定要歸檔的包裹。

We also expect to submit our complete regulatory package to the FDA by the end of 2021.

我們還希望在 2021 年底之前向 FDA 提交我們完整的監管包。

Our first authorization by a regulatory agency is expected to be followed by others over the coming weeks.

我們的第一個監管機構的授權預計將在未來幾週內得到其他人的認可。

We are turning swiftly to the work at hand to get product ready to ship on a global basis.

我們正在迅速轉向手頭的工作，以使產品準備好在全球範圍內發貨。

Timing and the location will, of course, depend on the timing of various regulatory approvals.

當然，時間和地點將取決於各種監管批准的時間。

We expect to be able to ship doses to Indonesia and hopefully others before the end of the year.

我們希望能夠在今年年底之前將劑量運送到印度尼西亞，並希望能運送到其他國家。

That will scale up quickly in the first quarter as we match our APA and COVAX orders with these regulatory approvals.

隨著我們將 APA 和 COVAX 訂單與這些監管批准相匹配，這將在第一季度迅速擴大。

We will initiate our shipments from Serum as the first authorized production center and supplement our regulatory filings with data from our other sites, importantly, including our Czech facility and our partner, SK Biosciences in Korea.

我們將作為第一個授權生產中心從 Serum 開始發貨，並用我們其他站點的數據補充我們的監管文件，重要的是，包括我們的捷克工廠和我們的合作夥伴韓國 SK Biosciences。

Our goal is to reach a cadence of production that will allow Novavax and our partners to have a manufacturing capacity of over 2 billion doses in 2022.

我們的目標是達到生產節奏，使 Novavax 和我們的合作夥伴在 2022 年擁有超過 20 億劑的製造能力。

And as we've indicated before, we will fulfill our commitments to higher-income countries from our APAs signed over the last year, and we expect to supply low- and middle-income countries in partnership with Serum to meet our commitments to COVAX.

正如我們之前所指出的，我們將履行我們在去年簽署的 APA 中對高收入國家的承諾，我們希望與 Serum 合作向低收入和中等收入國家供應，以履行我們對 COVAX 的承諾。

We believe that our vaccine is ideally suited to address the needs of these countries.

我們相信我們的疫苗非常適合滿足這些國家的需求。

In the coming months, we will continue to evaluate 2373 use beyond the 2-dose primary vaccination regimen through our ongoing boosting study and expect to collect data that further supports 2373's vast potential to serve as a booster.

在接下來的幾個月裡，我們將繼續通過我們正在進行的加強研究評估 2373 在 2 劑次主要疫苗接種方案之外的使用，並期望收集進一步支持 2373 作為加強劑的巨大潛力的數據。

Though our favorable reactogenity -- through our favorable reactogenicity and safety profile, consistently high levels of efficacy and well-understood technology, we are confident that 2373 will be an important tool in combating COVID-19 in the years to come.

儘管我們有利的反應原性——通過我們有利的反應原性和安全性、始終如一的高功效和廣為人知的技術，我們相信 2373 將成為未來幾年對抗 COVID-19 的重要工具。

In parallel, we will develop other areas of our robust pipeline.

與此同時，我們將開發我們強大管道的其他領域。

As discussed earlier by Filip, we believe our COVID NanoFlu combination vaccine will be a key component of our pipeline, and we look forward to advancing this candidate through clinical development.

正如 Filip 之前所討論的，我們相信我們的 COVID NanoFlu 聯合疫苗將成為我們管道的關鍵組成部分，我們期待通過臨床開發推進這一候選疫苗。

We also remain optimistic about areas for future development within our pipeline, including for RSV.

我們也對我們管道中的未來發展領域保持樂觀，包括 RSV。

Moving into the end of 2021, our mission will continue to drive us forward.

進入 2021 年底，我們的使命將繼續推動我們前進。

We never rest in our quest to protect the health of people everywhere.

我們從未停止追求保護世界各地人們的健康。

With that, I will now turn it over to the operator for Q&A.

有了這個，我現在將它交給運營商進行問答。

(Operator Instructions) Our first question comes from Kelechi Chikere of Jefferies.

（操作員說明）我們的第一個問題來自 Jefferies 的 Kelechi Chikere。

Again, congrats on all the progress here.

再次祝賀這裡取得的所有進展。

Just a couple of questions on my end.

我這邊只有幾個問題。

First, with the filings that you had over the last couple of weeks, a new development was that you're leveraging SII's manufacturing.

首先，根據您過去幾週提交的文件，一個新的發展是您正在利用 SII 的製造。

Can you help us understand the reasoning and rationale behind that?

你能幫助我們理解這背後的推理和理由嗎？

And I guess, more importantly, what are the gating steps and how quickly will you be able to supplement those applications and potential approvals with manufacturing data from your own sites?

而且我想，更重要的是，門控步驟是什麼？您能夠以多快的速度使用您自己站點的製造數據來補充這些應用程序和潛在的批准？

And I have one follow-up question there.

我有一個後續問題。

Yes.

是的。

This is Stan.

這是斯坦。

Thanks for the question.

謝謝你的問題。

The reason for our reliance upon Serum as a partner for this is they have -- we've been working with them for over almost 2 years in a variety of areas.

我們之所以依賴 Serum 作為合作夥伴，是因為他們已經在各個領域與他們合作了將近 2 年。

And so we know them really well.

所以我們非常了解他們。

And they have added capacity specifically for Novavax production over the past year that's staggering well over -- we're targeting 2 billion capacity.

在過去的一年中，他們專門為 Novavax 的生產增加了產能——我們的目標是 20 億產能。

Just at Serum, they'll have that next year.

就在血清，他們明年就會有。

And so they have fill/finish capacity that's virtually unlimited.

因此，它們的填充/完成能力幾乎是無限的。

We can make many hundreds of millions of doses per month in their facility.

我們可以在他們的設施中每月生產數億劑。

So all of that came together over the past several months and really helped us to get to the point where we could file with 9 different regulatory filings in the past couple of weeks.

所以在過去的幾個月裡，所有這些都匯集在一起，真正幫助我們達到了在過去幾週內可以提交 9 份不同監管文件的地步。

I mean this has been stupendous progress, and Serum has been there with us.

我的意思是這是驚人的進步，Serum 一直與我們同在。

So the follow-on to your question is what about the rest of our plants.

因此，您的問題的後續問題是我們其他工廠的情況。

We have data.

我們有數據。

We're collecting data that we will submit once we get regulatory approval in various territories, and we will supplement those filings with data from Korea, from Czech Republic, from Spain, et cetera, so we can get them all involved.

我們正在收集數據，一旦我們在各個地區獲得監管批准，我們將提交這些數據，我們將用來自韓國、捷克共和國、西班牙等國的數據來補充這些文件，這樣我們就可以讓他們都參與進來。

And so our global capacity network is really potent.

因此，我們的全球產能網絡非常強大。

Got it.

知道了。

That's really helpful.

這真的很有幫助。

And I guess you alluded to this in your answer.

我猜你在回答中提到了這一點。

Can you provide any color on how much vaccine or how much of the current capacity is actually coming from Serum Institute of India versus your own sites?

您能否就印度血清研究所與您自己的網站相比，提供多少疫苗或當前產能的任何顏色？

Actually, we don't split that out by manufacturing facility.

實際上，我們並沒有按製造工廠劃分。

But -- sorry.

但是——對不起。

The next question is from Vernon Bernardino of H.C. Wainwright.

下一個問題來自 H.C. 的 Vernon Bernardino。溫賴特。

Thank you for the update.

謝謝你的更新。

This is (inaudible).

這是（聽不清）。

I'm calling on behalf of Vernon.

我代表弗農打電話。

We just had a question on -- I guess, we wanted to get more color on the time line of how long would it take for the WHO and EUL review.

我們剛剛提出了一個問題——我想，我們希望在時間線上獲得更多色彩，即 WHO 和 EUL 審查需要多長時間。

And I just also wanted to -- just to confirm that the SII will actually manufacture the vaccine and that's it for me.

我也只是想——只是為了確認 SII 將實際生產疫苗，這就是我的想法。

Well, I think I answered the second part of the question that SII will be the initial manufacturer.

好吧，我想我回答了 SII 將成為初始製造商的問題的第二部分。

They've already made many tens of millions of doses that are waiting to be shippable.

他們已經製造了數以千萬計的劑量等待發貨。

They're sitting.

他們坐著。

We've -- my team has physically gone over there and touched them.

我們已經 - 我的團隊已經親自到過那裡並感動了他們。

And so it's -- they're there.

所以它是 - 他們在那裡。

The -- I forgot what was the first part of the question?

- 我忘記了問題的第一部分是什麼？

Just to -- we just wanted some more color on how long would it take for the WHO and the EUL review.

只是——我們只是想對WHO 和EUL 審查需要多長時間有更多的了解。

We can't -- we're not allowed to forecast how long it's going to take the regulatory -- the various regulatory agencies to opine on this.

我們不能 - 我們不允許預測監管需要多長時間 - 各種監管機構對此發表意見。

If -- my opinion is it's going to be soon.

如果——我的看法是很快就會發生。

So I think because we get -- we can judge their interest and their speed by how many questions they ask, and they've been in active, very active discussions with us.

所以我認為因為我們得到 - 我們可以通過他們提出的問題數量來判斷他們的興趣和速度，並且他們一直在與我們進行積極、非常積極的討論。

So I think we're going to follow with a number of regulatory -- positive regulatory actions following this Indonesia, I think soon.

所以我認為我們將在印度尼西亞之後採取一些監管 - 積極的監管行動，我認為很快。

The next question comes from Mayank Mamtani of B. Riley Securities.

下一個問題來自 B. Riley Securities 的 Mayank Mamtani。

Obviously, congrats on a ton of recent progress.

顯然，祝賀最近取得的大量進展。

So maybe just staying with the Serum question.

所以也許只是停留在血清問題上。

Are you able to comment on the economic arrangement you may have for the developed market specifically if Serum is the manufacturer?

如果 Serum 是製造商，您能否評論一下您對發達市場的經濟安排？

And also, are you able to comment on COGS if things -- if vaccines doses are coming from Serum versus the Novavax facility?

此外，您能否對 COGS 發表評論——如果疫苗劑量來自 Serum 與 Novavax 設施？

And then I have a follow-up.

然後我有一個跟進。

Yes.

是的。

So one of the reasons we partnered with them a year ago is because we recognized their capabilities for making large quantities of vaccine, They, in fact, in -- their model is to make vast amounts of vaccine at very low cost, and they've tied that to their target markets, which is all of the low- and middle-income countries of the world.

因此，我們一年前與他們合作的原因之一是因為我們認識到他們生產大量疫苗的能力，事實上，他們的模式是以非常低的成本生產大量疫苗，而且他們我們將其與他們的目標市場聯繫起來，即世界上所有的低收入和中等收入國家。

So that's been their target.

所以這就是他們的目標。

Our deal with them is that we agreed to license to them so that they can make product.

我們與他們的交易是我們同意向他們授予許可，以便他們可以生產產品。

They have an exclusive license in India to make and sell product.

他們在印度擁有製造和銷售產品的獨家許可。

And in the low- and middle-income countries of the world, we have -- we share profits on that.

在世界的低收入和中等收入國家，我們有 - 我們分享利潤。

And they'll make the product and distribute it, and we'll share products -- profits, and we have not disclosed what the ratio of that is.

他們將製造產品並分銷它，我們將分享產品——利潤，我們沒有透露比例是多少。

And we've also signed an agreement with them, if we want for them to make product for high-income markets.

如果我們想讓他們為高收入市場生產產品，我們還與他們簽署了一項協議。

And so we have a CDMO agreement with them.

因此，我們與他們簽訂了 CDMO 協議。

And so they would supply us finished product, whether -- in 1 of 2 ways, either from antigen, the spike protein that they make at Serum or from spike protein that we make in our various sites around the world.

所以他們會為我們提供成品，無論是 - 以兩種方式中的一種方式，要么來自抗原，他們在血清中製造的刺突蛋白，要么來自我們在世界各地製造的刺突蛋白。

And so we'll have the choice of working -- of having Serum fillet and produce it for us, produce the entire product for us or just take our manufacturing network and make our own product all the way through fill/finish and distribute it in high-income countries.

因此，我們可以選擇工作——擁有血清魚片並為我們生產，為我們生產整個產品，或者只是利用我們的製造網絡，通過填充/完成製造我們自己的產品並將其分發到高收入國家。

So it's complicated, but it's a very effective way to reach our strategy of going from 0 to 2 billion overnight.

所以它很複雜，但它是實現我們一夜之間從 0 到 20 億的戰略的非常有效的方法。

That's helpful color.

這是有用的顏色。

And then on the other side of the planet, on the U.S. FDA filing, as we think about the specific requirements you're working through, can you maybe detail, is it about the product itself that it has to come from facilities, maybe non-Serum facilities?

然後在地球的另一端，在美國 FDA 文件中，當我們考慮您正在解決的具體要求時，您能否詳細說明一下，產品本身是否必須來自設施，也許不是-血清設施？

Or is it just the release assays that have been agreed upon that the FDA has a different criteria, be it a percentage of material that sort of meets a particular potency or safety level?

或者僅僅是 FDA 已經同意的釋放分析有不同的標準，無論是符合特定效力或安全水平的材料的百分比嗎？

Just can you help us understand how much of what you have today could be also applicable to the U.S. FDA filing?

您能否幫助我們了解您今天擁有的有多少也適用於美國 FDA 備案？

Yes.

是的。

No, we made a concerted effort to harmonize all of our filings.

不，我們齊心協力協調我們所有的文件。

So we're going to file the same thing in the U.S. as we filed elsewhere.

因此，我們將在美國提交與在其他地方提交相同的文件。

And we are in the process of dealing with the FDA.

我們正在與 FDA 打交道。

We've had communication with them this week.

本週我們與他們進行了溝通。

We're going to set up a meeting sometime in the foreseeable future.

我們將在可預見的將來某個時候召開一次會議。

We don't know what date yet.

我們還不知道什麼日期。

We don't have a date yet, but sometime in the very near -- and from that, we can give more clarity on the dates that we expect to file the complete package and as for the EUA.

我們還沒有確定日期，但在不久之後的某個時間——從那時起，我們可以更清楚地說明我們希望提交完整包的日期以及 EUA 的日期。

So that will be coming later this month.

所以這將在本月晚些時候到來。

Great.

偉大的。

And my final question was on the pediatric study data time line.

我的最後一個問題是關於兒科研究數據的時間線。

I think you commented on the regulatory package in 1Q, but just can you clarify since that crossover finished a while ago, can someone comment on the data time line?

我想您對 1Q 的監管方案發表了評論，但您能否澄清一下，因為該交叉剛剛完成，有人可以評論數據時間線嗎？

Yes.

是的。

The analysis is ongoing, and it's made slightly more complicated by our current regulatory filings globally.

分析正在進行中，我們目前在全球範圍內提交的監管文件使分析變得更加複雜。

So we need to balance that work out.

所以我們需要平衡這項工作。

But we are confident that we'll be able to give the data pulled together and submitted it as a variation of our initial file in the first quarter.

但我們相信，我們將能夠將數據匯總在一起，並將其作為我們第一季度初始文件的變體提交。

The next question comes from Charles Duncan of Cantor Fitzgerald.

下一個問題來自 Cantor Fitzgerald 的 Charles Duncan。

Congratulations, Stan and team, for all the recent progress, very good to see.

恭喜 Stan 和團隊，最近取得了所有進展，非常高興。

I had a question regarding the EUA filings that I'm sure you won't be able to answer in great detail.

我有一個關於 EUA 申請的問題，我相信你無法詳細回答。

But beyond being able to talk about when you might see approvals, I'm wondering if you can characterize next steps and whether or not there would be some kind of interim information that can be press released besides an actual approval as Indonesia kind of came out from out of the blue.

但除了能夠談論您何時可能會看到批准之外，我想知道您是否可以描述下一步的步驟，以及隨著印度尼西亞的出現，除了實際批准之外，是否會有某種臨時信息可以發布出乎意料。

Yes.

是的。

I'm trying to interpret your question a little bit.

我試圖稍微解釋一下你的問題。

I -- we are expecting multiple authorizations this year.

我——我們預計今年會獲得多項授權。

And for each of these, we are trying to allocate product, both that we have in inventory in the U.S. and Europe and South Korea and in inventory that's being built up at Serum.

對於其中的每一個，我們都在嘗試分配產品，包括我們在美國、歐洲和韓國的庫存以及在 Serum 建立的庫存。

And that allocation process will be complicated because until we know what the -- not only what the -- when we get the authorization, but the timing of all of these different orders.

這個分配過程會很複雜，因為直到我們知道什麼——不僅是什麼——當我們獲得授權時，還有所有這些不同訂單的時間安排。

And from Gavi, we need to know where they want product when and over the coming quarters and the same thing from our APAs.

從 Gavi 那裡，我們需要知道他們在未來幾個季度何時以及在哪裡需要產品，以及我們的 APA 提供的相同信息。

And so we'll be building them -- we are building inventory, and we'll be -- over the coming weeks, we'll be figuring out how to allocate those to label them for different geographies.

因此，我們將建立它們——我們正在建立庫存，我們將——在接下來的幾週內，我們將弄清楚如何分配這些以將它們標記為不同的地區。

Does that answer your question?

這是否回答你的問題？

I'm not sure I did.

我不確定我做到了。

Yes.

是的。

I apologize, Stan.

我道歉，斯坦。

I think I wasn't clear.

我想我不清楚。

What I was asking is if you would anticipate any part of the regulatory process to be visible to the public for any one of these Emergency Use Authorizations over the course of the next some period of time before an actual grant of an authorization.

我要問的是，在實際授予授權之前，您是否預計在接下來的一段時間內，任何一項緊急使用授權的監管流程的任何部分都對公眾可見。

I don't think we're going to have much visibility before the actual grant of an authorization.

我認為在實際授予授權之前我們不會有太多的知名度。

We have -- the process is they do the review.

我們有——流程是他們進行審查。

They've had the ability to review the clinical safety data for some time now because those have been submitted to the regulatory agencies.

他們有能力審查臨床安全數據已有一段時間了，因為這些數據已提交給監管機構。

So the remaining analysis should be focusing on the CMC section.

所以剩下的分析應該集中在CMC部分。

And we can only know -- and of course, it's not announceable.

我們只能知道——當然，它是不可公佈的。

We could only know how interested they are by the number of questions we get and the responses we get back and whether they think they've got all the answers to their questions.

我們只能通過我們收到的問題數量和我們得到的回復以及他們是否認為他們已經獲得了所有問題的答案來了解他們的興趣。

And so there's not going to be any information going forward about the EUA until it happens.

因此，在 EUA 發生之前，不會有任何關於 EUA 的信息。

But all I'm suggesting to you is I'm optimistically forecasting that they're going to be working on this quickly.

但我向你建議的只是我樂觀地預測他們將很快著手解決這個問題。

And so we're looking at this, from week to week we're going to see results of that.

所以我們正在研究這個，每週都會看到結果。

Okay.

好的。

Very good.

很好。

That's helpful.

這很有幫助。

If I could turn to Filip or Greg regarding a couple of clinical questions.

如果我可以就幾個臨床問題向菲利普或格雷格求助。

First of all, I'm wondering if you have ever seen any cases of myocarditis that you think go beyond that which is seen with the virus with an infection generally.

首先，我想知道您是否見過任何您認為超出一般感染病毒的心肌炎病例。

And if you could provide some kind of theoretical basis for not seeing any cases or foreseeing cases and perhaps even in contrast with other technologies.

如果你能提供某種理論基礎，讓你看不到任何案例或預見到案例，甚至可能與其他技術形成對比。

So we don't really comment on specific safety signals we've seen or not seen in any of our studies.

因此，我們不會真正評論我們在任何研究中看到或未看到的特定安全信號。

What we can -- what we all know is that myocarditis is often caused by viral infections, and those occur sporadically throughout the planet.

我們能做的——我們都知道心肌炎通常是由病毒感染引起的，而且這些病毒感染在全球範圍內偶爾發生。

So they do crop up in any database you look at.

因此，它們確實會出現在您查看的任何數據庫中。

Our data is reviewed by not only our external safety committee as well as by the NIHD SMB, and they haven't identified any safety signals for us yet.

我們的數據不僅由我們的外部安全委員會以及 NIHD SMB 審查，他們還沒有為我們確定任何安全信號。

Okay.

好的。

Very good.

很好。

Last question regarding homologous versus heterologous boost.

關於同源與異源增強的最後一個問題。

Wondering if you could provide a little bit of perspective on homologous boost, seems like should work given the data that you've shown so far in 6 months.

想知道您是否可以提供一些關於同源提升的觀點，鑑於您在 6 個月內迄今為止顯示的數據，似乎應該可行。

But do you sense that maybe heterologous boost may be a paradigm that you want to evaluate in the future?

但是您是否感覺到異源增強可能是您將來想要評估的一種範式？

And is there at least a theoretical basis for thinking that 2373 could be useful on top of, say, past RNA primary boost.

並且至少有一個理論基礎可以認為 2373 在過去的 RNA 初級增強之上可能有用。

Yes.

是的。

So we've outlined the details of our homologous boosting just today, and we think there's a path forward, and we see an obvious way to get a label indication for that.

所以我們今天已經概述了我們同源增強的細節，我們認為有一條前進的道路，我們看到了一種明顯的方式來獲得標籤指示。

We also see huge value in boosting on top of other people's vaccines.

我們還看到了在其他人的疫苗之上推廣的巨大價值。

We have a safety profile that I think will justify doing that and a posology, which makes it convenient to move the vaccine around the world and use in that regard.

我們有一個我認為可以證明這樣做的安全性和一個劑量學，這使得在世界各地移動疫苗並在這方面使用變得很方便。

How well it performs, we'll really be data-driven.

它的表現如何，我們將真正成為數據驅動的。

Now we plan to do some studies in the near future to help define that, including studies we're designing to provide enough data to give us a label indication.

現在我們計劃在不久的將來做一些研究來幫助定義它，包括我們正在設計的研究，以提供足夠的數據來給我們一個標籤指示。

There will be some data coming out from the U.K. studies, as everyone on this call knows, that may shed some light into it.

正如本次電話會議上的每個人都知道的那樣，英國的研究將會得出一些數據，這可能會有所啟發。

But those studies aren't designed in such a way to be able to provide label claims, and that's really our goal.

但這些研究的設計方式並不是能夠提供標籤聲明，而這確實是我們的目標。

So as far as the theoretical side of things, there isn't a ton known about what it looks like to boost on top of other platforms.

因此，就事物的理論方面而言，對於它在其他平台之上的提升是什麼樣子的，並沒有太多的了解。

There's more known about it looks like to boost on top of viral platforms versus mRNA.

有更多人知道它看起來像是在病毒平台上而不是 mRNA 上增強。

So I think we'll have to wait for the data to come out.

所以我認為我們將不得不等待數據出來。

What I do feel confident about is that if you were to stack up any homologous or heterologous redose regime compared to what we've shown in the Phase II study from U.S. and Australia, I'm pretty confident we would come out on top or in parity with that.

我確實有信心的是，與我們在美國和澳大利亞的 II 期研究中顯示的相比，如果你要堆疊任何同源或異源的再劑量方案，我很有信心我們會脫穎而出或在與之相稱。

And I have to say that there's something pretty unique about what we're seeing about our ability to induce cross-variant neutralizing antibodies, and that may be part of the story.

我不得不說，我們所看到的關於我們誘導交叉變異中和抗體的能力有一些非常獨特的東西，這可能是故事的一部分。

So people shouldn't just think about magnitude of immune response, but quality of immune response as well.

所以人們不應該只考慮免疫反應的大小，還要考慮免疫反應的質量。

Okay.

好的。

Very good.

很好。

That's helpful.

這很有幫助。

Again, congrats on all the recent progress.

再次祝賀最近取得的所有進展。

The next question is from Eric Joseph of JPMorgan.

下一個問題來自摩根大通的 Eric Joseph。

I just wanted to circle back on plans to supplement the current filings with CMC packages from your own supply chain.

我只是想回顧一下用你自己的供應鏈中的 CMC 包來補充當前文件的計劃。

Could this happen before or is it more likely to happen after the anticipated decisions, authorization decisions for regions filed over the past week.?

這會發生在預期的決定、過去一周提交的地區授權決定之前，還是更有可能發生在之後。？

And as a follow-up to that, with -- if it's primarily Serum that's making COVOVAX effectively over the near term, how should we be thinking about dose allocation between your commitments with COVAX, the COVAX facility and higher-income countries?

作為後續行動，如果主要是血清在短期內有效地生產 COVOVAX，我們應該如何考慮您對 COVAX、COVAX 設施和高收入國家的承諾之間的劑量分配？

I guess is there a prioritization of doses to COVAX first?

我想COVAX的劑量是否有優先順序？

And then I have a follow-up.

然後我有一個跟進。

Yes.

是的。

Good.

好的。

This is Stan.

這是斯坦。

Thanks for the question -- for the questions.

感謝您的提問——提問。

The supplementary filings will be filed as soon as we can.

補充文件將盡快提交。

I think that we've -- if you can imagine that our team has filed 9 applications, regulatory submissions and we've got a few more countries to go, that's going to consume them.

我認為我們已經 - 如果你可以想像我們的團隊已經提交了 9 份申請和監管文件，而且我們還有更多國家要去，那將會消耗它們。

But we'll get the supplements in either around the time that they're approval or just after.

但是我們會在他們批准時或之後獲得補充。

And I think that we're talking weeks here.

我認為我們在這裡討論了幾週。

I don't think we're talking months, so I don't think there's going to be much difference.

我不認為我們在談論幾個月，所以我認為不會有太大的不同。

Going back to your allocation, how it's going to work with Serum.

回到你的分配，它如何與 Serum 一起工作。

Serum is going to make the bulk of the production over the next few months.

Serum 將在接下來的幾個月裡生產大部分產品。

We are going to allocate -- we're going to focus on COVAX and make sure that they get their allocation.

我們將分配 - 我們將專注於 COVAX 並確保他們獲得分配。

It won't be 100% of our product out of there, but it will be a large portion for the first few months, and then it will shift over to our APAs in large quantities, I think, in the second and third quarter.

它不會是我們產品的 100%，但在最初的幾個月裡會佔很大一部分，然後我認為在第二和第三季度它將大量轉移到我們的 APA。

So the first -- the next -- this quarter and next quarter, we're going to have a lot of -- our mission is to get a lot of product out to low- and middle-income countries as soon as we can get WHO EUL and Gavi, and that will take a little time.

所以第一個 - 下一個 - 本季度和下一季度，我們將有很多 - 我們的任務是盡快將大量產品提供給低收入和中等收入國家WHO EUL 和 Gavi，這需要一點時間。

And so during -- so there'll be some time when we can ship to other countries as well.

所以在此期間 - 所以會有一段時間我們也可以運送到其他國家。

So it's a mix right now.

所以現在是混合的。

And as these regulatory submissions get authorization, we'll see how product flows.

隨著這些監管提交獲得授權，我們將看到產品如何流動。

But the scale up of the product at Serum is -- and our places is fairly dramatic.

但是 Serum 產品的擴大規模是——而且我們的地方是相當引人注目的。

And it's not going to really make a difference what plant it comes from.

它來自什麼植物並不會真正改變它。

Okay.

好的。

Okay.

好的。

And just with the decision here to use Serum's CMC package here.

只是決定在這裡使用 Serum 的 CMC 包。

I guess is there precedent with the Serum-made vaccine that gives you confidence in dosing approval...

我想血清製造的疫苗是否有先例讓您對劑量批准充滿信心......

Yes, that's correct.

對，那是正確的。

In higher-income countries like Europe, et cetera?

在歐洲等高收入國家？

Sure.

當然。

AZ, they've made over 1 billion doses of AZ's vaccine, and they've got an approval globally for that.

AZ，他們已經生產了超過 10 億劑 AZ 的疫苗，並且他們已經獲得了全球的批准。

So there's lots of precedent.

所以有很多先例。

And by the way, they also got inspected by the U.K. and specifically for Novavax production at their plants and got a GMP certificate that allows them.

順便說一句，他們還接受了英國的檢查，特別是他們工廠的 Novavax 生產，並獲得了允許他們生產的 GMP 證書。

And so their plants are probably some of the most modern plants in the world, and they're highly regarded by the regulatory agencies who've seen them.

因此，他們的工廠可能是世界上最現代化的工廠之一，並且受到看過它們的監管機構的高度評價。

Okay.

好的。

AZ also had their own supply chain where you could have comparability there.

AZ 也有自己的供應鏈，您可以在那裡進行比較。

I guess is there any clinical data with -- the clinical data using Serum-made product that I guess is included in the overall mission package?

我想是否有任何臨床數據——我猜是使用血清製成的產品的臨床數據包含在整個任務包中？

Yes, they did -- Filip can describe the trial.

是的，他們做到了——菲利普可以描述這次審判。

They conducted a Phase II, Phase III study comparing a material that they manufacture with material that we manufactured, and that's part of the regulatory dossier.

他們進行了一項 II 期和 III 期研究，將他們製造的材料與我們製造的材料進行比較，這是監管檔案的一部分。

And this will conclude our question-and-answer session.

這將結束我們的問答環節。

I'd like to turn the conference back over to Stan for any closing remarks.

我想把會議轉回給 Stan 做任何閉幕詞。

Yes.

是的。

I'm reflecting on this conversation, and we'll go off script for a minute, but we've really accomplished something as a company in the 12 years that I've been here that is just changing the entire company.

我正在反思這次談話，我們會暫時離開劇本，但作為一家公司，在我在這裡的 12 年裡，我們確實取得了一些成就，這正在改變整個公司。

The energy that's coming out of the company after all of these regulatory filings and getting the first -- your first product approval is a big deal, and the company is pumped and we're on our way to really be in a changed company over the coming 12 months.

在所有這些監管文件提交並獲得第一個之後，公司產生的能量 - 你的第一個產品批准是一件大事，公司被抽水了，我們正在努力真正成為一家改變的公司未來 12 個月。

So I want to thank you to everyone for joining today's call.

所以我要感謝大家參加今天的電話會議。

We're excited by our progress made to date and believe we are positioned for success in the months to come, and we look forward to reporting on the exciting milestones.

我們對迄今為止取得的進展感到興奮，並相信我們將在未來幾個月取得成功，我們期待著報告令人興奮的里程碑。

And this says in the coming months, I'm going to be reporting on exciting milestones in the coming weeks and months ahead of us as we move closer to delivering our vaccine globally.

這意味著在接下來的幾個月裡，隨著我們越來越接近在全球範圍內提供我們的疫苗，我將在接下來的幾周和幾個月內報告令人興奮的里程碑。

So with that, thank you very much.

因此，非常感謝。

Thank you.

謝謝你。

The conference has now concluded.

會議現已結束。

Thank you all for attending today's presentation.

感謝大家出席今天的演講。

You may now disconnect your lines.

您現在可以斷開線路。

Have a great day.

祝你有美好的一天。