Novavax Inc (NVAX) 2021 Q1 法說會逐字稿

Good day and welcome to the Novavax First Quarter 2021 Financial Results and Operational Highlights Conference Call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加 Novavax 2021 年第一季度財務業績和運營亮點電話會議。 （操作員說明）請注意正在記錄此事件。

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

我現在想將會議轉交給投資者關係和公司事務高級副總裁 Silvia Taylor。請繼續。

Good afternoon, and thank you to everyone who has joined today's call to discuss our first quarter 2021 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com. An audio archive of this conference call will be available on our website later today. The presentation slides we will be using for this call are all on our website in the Events section.

下午好，感謝所有加入今天電話會議的人，討論我們 2021 年第一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。我們將用於此次電話會議的演示幻燈片都在我們網站的“活動”部分。

Joining me today are Stan Erck, President and CEO, who will provide an overview of our progress in the first quarter as well as updates on the regulatory time lines in our manufacturing scale-up. Additionally, Dr. Greg Glenn, President of Research and Development, will provide an update on our global clinical development. John Trizzino, Chief Commercial Officer, Chief Business Officer and Interim Chief Financial Officer, will provide an update on our supply commitments and financial results for the quarter. Additionally, Dr. Filip Dubovsky, Chief Medical Officer, 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，他將概述我們在第一季度的進展，以及我們擴大製造規模的監管時間表的更新。此外，研發總裁 Greg Glenn 博士將提供我們全球臨床開發的最新情況。首席商務官、首席商務官兼臨時首席財務官 John Trizzino 將提供我們本季度供應承諾和財務業績的最新信息。此外，首席醫療官 Filip Dubovsky 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 that could include financial, clinical or commercial projections. Statements relating to future financial or business performance, conditions or strategies and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage and clinical development and anticipated milestones, are forward-looking statements within the mandate of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time.

在我們開始準備評論之前，我需要提醒您，我們將在這次電話會議期間做出前瞻性陳述，其中可能包括財務、臨床或商業預測。與未來財務或業務業績、條件或戰略以及其他財務和業務相關事項有關的陳述，包括對收入、運營費用、現金使用和臨床開發的預期以及預期的里程碑，是私人證券授權範圍內的前瞻性陳述訴訟改革法。 Novavax 告誡說，這些前瞻性陳述受許多假設、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而變化。

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。

Thank you, Silvia, and thank you to everyone for joining us today. In the first quarter, we built on our many achievements of 2020 -- every aspect of our business. I'm proud to say we remain tireless in our efforts, delivering on key clinical milestones, advancing efforts to ready our global supply chain for commercialization and progressing 2373 towards regulatory authorization around the world.

謝謝你，Silvia，也謝謝大家今天加入我們。在第一季度，我們在 2020 年取得的許多成就的基礎上再接再厲——我們業務的各個方面。我很自豪地說，我們將繼續不懈地努力，實現關鍵的臨床里程碑，推動我們的全球供應鍊為商業化做好準備，並推動 2373 在全球範圍內獲得監管授權。

I'd like to begin today's call by first providing a recap of some of our key achievements in the first quarter, including the fall. We announced both interim and final analyses in our South Africa Phase IIb and U.K. Phase III trials. We demonstrated 2373's favorable safety profile, immunogenicity and outstanding efficacy against multiple strains of COVID-19. We continue to advance our PREVENT-19 pivotal Phase III trials in the U.S., including expanding the study into pediatric populations. We initiated multiple crossover and booster arms in order to refine our visitor strategy, which will be key to our future. We leveraged our platform to advance the development of both our variant strains combination vaccines into preclinical studies.

我想首先回顧一下我們在第一季度（包括秋季）的一些關鍵成就，開始今天的電話會議。我們在南非 IIb 期和英國 III 期試驗中宣布了中期和最終分析。我們展示了 2373 對多種 COVID-19 菌株的良好安全性、免疫原性和出色的療效。我們繼續在美國推進我們的 PREVENT-19關鍵 III 期試驗，包括將研究擴展到兒科人群。我們啟動了多個交叉和助推器，以完善我們的訪客策略，這將是我們未來的關鍵。我們利用我們的平台將我們的兩種變異株組合疫苗的開發推進到臨床前研究中。

In our global supply chain, we expanded our global presence with new manufacturing agreements as well as advancing our existing partnerships. We successfully began GMP manufacturing at commercial scale at all of our sites. We secured additional supply agreements including finalizing an APA with Gavi for a commitment of 1.1 billion doses to address global equitable access to our vaccine in partnership with the Serum Institute of India. We'll talk later about this. We progressed our dialogue with regulatory authorities globally, making significant progress towards completing CMC and the remaining clinical requirements.

在我們的全球供應鏈中，我們通過新的製造協議擴大了我們的全球影響力，並推進了我們現有的合作夥伴關係。我們在所有工廠都成功地開始了商業規模的 GMP 生產。我們獲得了額外的供應協議，包括與 Gavi 敲定 APA，承諾與印度血清研究所合作提供 11 億劑疫苗，以解決全球公平獲取我們疫苗的問題。我們稍後會談到這個。我們推進了與全球監管機構的對話，在完成 CMC 和剩餘的臨床要求方面取得了重大進展。

Today, we are pleased to share more details on our recent progress. I will ask other members of our management team and talk about our clinical progress and plans, about the status and expectations that we have for advanced purchase agreements during this pandemic period, stretching over the next couple of years, and about our financial performance in the first quarter. Then I'd like to take back the microphone to cover a couple of important areas.

今天，我們很高興分享我們最近取得的進展的更多細節。我將詢問我們管理團隊的其他成員，並討論我們的臨床進展和計劃，在這個大流行期間我們對提前購買協議的狀態和期望，以及我們在未來幾年的財務表現。第一季度。然後我想收回麥克風來覆蓋幾個重要領域。

Point 1, I'd like to update our guidance on a couple of near-term deliveries that we get daily questions on. And point 2, I'd like to start focusing the attention of our investors on what the mid to longer term outlook looks like for Novavax. It's a picture that is very compelling.

第 1 點，我想更新我們對一些我們每天都會收到問題的近期交付的指導。第 2 點，我想開始將我們的投資者的注意力集中在 Novavax 的中長期前景上。這是一張非常引人注目的照片。

With that, I would now like to hand it over to Greg Glenn to discuss our clinical developments in the first quarter. He'll be followed by John Trizzino and then all rejoined.

有了這個，我現在想把它交給 Greg Glenn 來討論我們在第一季度的臨床發展。 John Trizzino 將跟隨他，然後全部重新加入。

Thanks, Stan. Turning to Slide 4. In the first quarter, we made excellent progress in advancing 2373 through our various clinical trials. As Stan mentioned, we announced both interim data and final analyses for our South Africa Phase IIb and U.K. Phase III trials, rapidly completed our enrollment of our PREVENT-19 Phase III trial and initiated a number of other studies building on the excellent safety and efficacy data generated to date. In the next few slides, I will give an overview of these key clinical developments from the quarter as well as discuss our upcoming clinical milestones.

謝謝，斯坦。轉到幻燈片 4。第一季度，我們通過各種臨床試驗在推進 2373 方面取得了顯著進展。正如 Stan 所提到的，我們公佈了南非 IIb 期和英國 III 期試驗的中期數據和最終分析，迅速完成了我們的 PREVENT-19 III 期試驗的註冊，並在卓越的安全性和有效性的基礎上啟動了許多其他研究迄今為止生成的數據。在接下來的幾張幻燈片中，我將概述本季度的這些關鍵臨床進展，並討論我們即將到來的臨床里程碑。

Beginning with our South Africa Phase IIb trial on Slide 5. In the complete analysis from this trial, which included over 4,400 participants, 2373 achieved its primary endpoint, demonstrated overall efficacy of 48.6% and efficacy of 55.4% amongst HIV negative trial participants. We also confirm II/III efficacies against the B.1.351 variant first identified in South Africa, demonstrating approximately 51% efficacy against mild, moderate or severe disease against this variant in HIV negative participants. Importantly, there were no severe cases in the vaccine group and 5 severe cases, including 2 deaths, in the placebo group. Four out of 5 were due to the variant of concern, B.1.351. Last week, full results from our South Africa Phase IIb study were published in the New England Journal.

從我們在幻燈片 5 上的南非 IIb 期試驗開始。在這項試驗的完整分析中，包括 4,400 多名參與者，2373 人達到了主要終點，在 HIV 陰性試驗參與者中顯示出 48.6% 的總體療效和 55.4% 的療效。我們還證實了針對在南非首次發現的 B.1.351 變體的 II/III 功效，證明在 HIV 陰性參與者中針對這種變異的輕度、中度或重度疾病的功效約為 51%。重要的是，疫苗組沒有重症病例，安慰劑組有5例重症病例，包括2例死亡。 5 個中有 4 個是由於關注的變體 B.1.351。上週，我們南非 IIb 期研究的全部結果發表在《新英格蘭雜誌》上。

Now moving to Slide 6. You can see a summary of results from the final analysis of our U.K. Phase III trial, which included over 15,000 participants. In this trial, 2373 achieved its primary efficacy endpoint, demonstrating overall efficacy of 89.7%. The final analysis also confirmed 2373's high efficacy against multiple variants of COVID-19, demonstrating 96.4% efficacy against the original COVID-19 and 86.3% efficacy against the B.1.1.7 variant, first identified in the U.K.

現在轉到幻燈片 6。您可以看到我們英國 III 期試驗的最終分析結果摘要，其中包括 15,000 多名參與者。在這項試驗中，2373 達到了其主要療效終點，顯示總體療效為 89.7%。最終分析還證實了 2373 對 COVID-19 的多種變體的高療效，證明對原始 COVID-19 的療效為 96.4%，對 B.1.1.7 變體的療效為 86.3%，首次在英國發現。

The final analysis also showed that 14 days after 1 dose, vaccine efficacy was 83.4%. In participants 65 years of age and older, we demonstrated a vaccine efficacy of 89%. And finally, over 40% of the study participants in this trial had medical comorbidities that placed them at high-risk for severe COVID disease. Among this group, 2373 demonstrated a 90.9% efficacy. We view this as particularly important, illustrating 2373's ability to protect a portion of the population at high-risk for COVID-19 disease. Our results from this trial have been submitted for publication in a peer-reviewed journal and posted to net archives.

最終分析還顯示，1劑後14天，疫苗有效率為83.4%。在 65 歲及以上的參與者中，我們證明了 89% 的疫苗效力。最後，在這項試驗中，超過 40% 的研究參與者患有合併症，使他們面臨嚴重的 COVID 疾病的高風險。在這組中，2373 例顯示了 90.9% 的療效。我們認為這一點尤為重要，說明 2373 有能力保護部分處於 COVID-19 疾病高風險人群中的能力。我們的這項試驗結果已提交給同行評審期刊發表，並發佈到網絡檔案中。

In summary, on Slide 7, 2373 has shown excellent efficacy in trials conducted in settings where both the original and variant strains were circulating. Importantly, in both trials, 2373 demonstrated 100% protection against severe disease and it was well tolerated. Adverse events were balanced between the vaccine and placebo group. At this time, we have also initiated crossover arms in both trials, which will help further inform our booster strategy.

總之，在幻燈片 7 上，2373 在原始菌株和變異菌株都在傳播的環境中進行的試驗中顯示出出色的功效。重要的是，在這兩項試驗中，2373 都顯示出 100% 的針對嚴重疾病的保護作用，並且耐受性良好。疫苗組和安慰劑組之間的不良事件是平衡的。目前，我們還在兩個試驗中啟動了交叉臂，這將有助於進一步了解我們的助推器策略。

Now turning to our PREVENT-19 Phase III trial in Slide 8. In the U.S. and Mexico, where we are conducting this trial, we announced that in February, we had completed enrollment for this trial -- this Phase III trial. The notably diverse study population included 30,000 participants from a wide range of demographic backgrounds as well as individuals who are at high-risk of COVID-19 due to factors such as medical comorbidities or age.

現在轉到幻燈片 8 中的 PREVENT-19 III 期試驗。在我們正在進行這項試驗的美國和墨西哥，我們宣佈在 2 月份，我們已經完成了這項試驗的註冊——這項 III 期試驗。顯著多樣化的研究人群包括來自廣泛人口背景的 30,000 名參與者，以及由於醫學合併症或年齡等因素而處於 COVID-19 高風險的個人。

At the end of April, we also implemented a blinding crossover allowing all subjects in our PREVENT-19 trial to receive active vaccine. The successful conduct of the trial will allow unblinding for a final analysis as opposed to an interim analysis, based on the events we've accrued prior to crossover as the trial is well powered to describe efficacy. Stan will discuss the timing of announcements in more detail later in the call. The updated protocol has been posted to our website today.

4 月底，我們還實施了盲法交叉，允許我們 PREVENT-19 試驗中的所有受試者接受活性疫苗。根據我們在交叉之前積累的事件，該試驗的成功進行將允許對最終分析進行揭盲，而不是中期分析，因為該試驗能夠很好地描述療效。 Stan 將在稍後的電話會議中更詳細地討論公告的時間安排。更新後的協議今天已發佈到我們的網站。

Moving to Slide 9. PREVENT-19, which have been enrolling U.S. participates in December of last year, was also conducted in the context of a rapid emergent of variant strains. By the end of April, at the close of the endpoint accrual period, we've seen the rapid rise of B.1.1.7 strain. This variant now accounts for over 60% of the U.S. cases. But as I mentioned, in our U.K. Phase III study, we showed that 2373 was 86% effective against the B.1.1.7 variant and 96% effective against the original strain of COVID-19.

轉到幻燈片 9。去年 12 月已招募美國參與的 PREVENT-19 也是在變異菌株迅速出現的背景下進行的。到 4 月底，在終點應計期結束時，我們已經看到 B.1.1.7 菌株的快速上升。這種變體現在占美國病例的 60% 以上。但正如我所提到的，在我們的英國 III 期研究中，我們表明 2373 對 B.1.1.7 變體的有效率為 86%，對 COVID-19 的原始菌株有效率為 96%。

And now turning to Slide 10. We also initiated a pediatric extension of PREVENT-19 in April. On this slide, you can see the study design, which includes 3,000 adolescent participants, 12 to 17 years old, across 75 trial sites in the U.S. 2/3 of the participants will receive 2373 and 1/3 will receive placebo in order to evaluate the efficacy, safety and immunogenicity of 2373. We see this as an important step towards expanding the reach of our vaccine and making progress towards ending the pandemic. We expect to implement a blinded crossover of 6 months after the initial set of vaccinations.

現在轉到幻燈片 10。我們還在 4 月啟動了 PREVENT-19 的兒科擴展。在這張幻燈片上，您可以看到研究設計，其中包括美國 75 個試驗地點的 3,000 名 12 至 17 歲的青少年參與者。2/3 的參與者將接受 2373，1/3 的參與者將接受安慰劑，以評估2373 的功效、安全性和免疫原性。我們認為這是擴大我們的疫苗覆蓋範圍和在結束大流行方面取得進展的重要一步。我們預計在最初的一組疫苗接種後 6 個月內實施盲交叉。

In parallel with advancing 2373 through our various efficacy trials, we saw significant progress in 2 other areas of our clinical program in the first quarter. Our variant strain, COVID-19 variant vaccine and combination vaccine candidates. I would like to briefly touch on our recent developments of these 2 programs.

在通過我們的各種療效試驗推進 2373 的同時，我們在第一季度看到了我們臨床項目的其他兩個領域的重大進展。我們的變異株、COVID-19 變異疫苗和聯合候選疫苗。我想簡單談談我們最近對這兩個項目的發展。

Last week, we shared preliminary data at the World Vaccine Congress from a preclinical study of our B.1.351 candidate, which you can see on Slide 12. As a part of this work, primates who originally received a 2-dose regimen of 2373 last year were boosted 1 year later with our B.1.351 candidate, containing Matrix-M adjuvant. Data from this study showed within 7 days of receiving the B.1.351 booster, animals exhibited strong functional immune response. Immunity debt, as we showed at the World Vaccine Congress, can block 1.351 spike from binding to ACE2. We'll have more to say on this work in the coming weeks.

上週，我們在世界疫苗大會上分享了我們的 B.1.351 候選疫苗的臨床前研究的初步數據，您可以在幻燈片 12 上看到。作為這項工作的一部分，最初接受 2 劑 2373 方案的靈長類動物最後一年後用我們的 B.1.351 候選藥物加強了一年，其中含有 Matrix-M 佐劑。這項研究的數據顯示，在接受 B.1.351 加強劑的 7 天內，動物表現出強烈的功能性免疫反應。正如我們在世界疫苗大會上展示的那樣，免疫債務可以阻止 1.351 峰值與 ACE2 結合。在接下來的幾週內，我們將就這項工作發表更多意見。

Finally, turning to Slide 13. We also dedicated significant efforts during the quarter to exploring various combination vaccines, including a combined NanoFlu 2373 vaccine candidate, all combined with Matrix-M adjuvant. We recently completed a preclinical study of this combination vaccine to assess its immunogenicity and protective efficacy in animal models, and the data are summarized in the manuscript posted to bio archive.

最後，轉向幻燈片 13。我們還在本季度投入了大量精力來探索各種聯合疫苗，包括聯合 NanoFlu 2373 候選疫苗，均與 Matrix-M 佐劑結合。我們最近完成了這種聯合疫苗的臨床前研究，以評估其在動物模型中的免疫原性和保護效力，數據總結在發佈到生物檔案的手稿中。

Briefly, we found that the combination NanoFlu 2373 vaccine induced strong functional antibodies in ferrets with hemagglutinin inhibition antibodies and ACE2 receptor inhibiting antibodies that were comparable between immunization with both a combination vaccine and respective component vaccines. In these animals, the combination vaccine induced high levels of anti-spike and neutralizing antibodies.

簡而言之，我們發現 NanoFlu 2373 聯合疫苗在雪貂中誘導了強大的功能性抗體，其中血凝素抑制抗體和 ACE2 受體抑制抗體在聯合疫苗和各自成分疫苗的免疫之間具有可比性。在這些動物中，聯合疫苗誘導了高水平的抗尖峰和中和抗體。

When immunized hamsters were challenged with SARS-CoV, the quadrivalent and 2373 combination vaccine showed protection which was not diminished compared to the 2373 alone. No viral replication was detected 4 days after the COVID challenge and the lung showed no changes. These results demonstrate that a novel combination of flu COVID vaccine has the potential for a transformative impact on both diseases. We expect to bring this candidate into clinical trials later this year.

當免疫倉鼠受到 SARS-CoV 攻擊時，四價疫苗和 2373 聯合疫苗顯示出與單獨使用 2373 相比沒有減弱的保護作用。在 COVID 攻擊後 4 天未檢測到病毒複製，肺部未顯示任何變化。這些結果表明，流感 COVID 疫苗的新組合具有對這兩種疾病產生變革性影響的潛力。我們預計將在今年晚些時候將該候選人帶入臨床試驗。

I would also like to highlight on Slide 14, ongoing clinical trials conducted by our partners, reflecting collaboration around the world for development of our COVID vaccine. These include both a Phase I/II trial conducted by Takeda in Japan as well as a Phase II/III clinical trial conducted by the Serum Institute of India to evaluate the safety and immunogenicity of 2373.

我還想在幻燈片 14 上強調我們的合作夥伴正在進行的臨床試驗，反映了世界各地為開發我們的 COVID 疫苗而進行的合作。其中包括武田在日本進行的 I/II 期試驗以及印度血清研究所進行的 II/III 期臨床試驗，以評估 2373 的安全性和免疫原性。

These trials were initiated in the first quarter. Enrollment is complete in the Takeda trial and enrollment is about to begin in the Phase III portion of the Serum trial. We look forward to sharing additional updates as these trials progress and expect these clinical trials led by our partners will play a meaningful role in promoting global access to our vaccine.

這些試驗是在第一季度開始的。武田試驗的登記已完成，血清試驗的第三階段部分即將開始登記。隨著這些試驗的進展，我們期待分享更多的更新，並期望我們的合作夥伴領導的這些臨床試驗將在促進全球獲得我們的疫苗方面發揮有意義的作用。

Next, I would like to discuss the combo study, which was initiated in April. This is a U.K. government-sponsored study being conducted by the University of Oxford that will assess 2 dose priming and boost regimens of COVID vaccines, mixing the AZ, Pfizer, Moderna and Nova vaccines in various combinations, given 8 weeks apart. The study will evaluate the safety and immunogenicity with results expected in the third quarter.

接下來，我想討論一下四月份啟動的組合研究。這是一項由英國政府資助的研究，由牛津大學進行，將評估 COVID 疫苗的 2 劑初免和加強方案，將 AZ、輝瑞、Moderna 和 Nova 疫苗以各種組合混合，相隔 8 週。該研究將評估安全性和免疫原性，預計在第三季度獲得結果。

We also wish to highlight an exciting collaboration regarding an important advance in malaria prevention. The University of Oxford's malaria vaccine candidate R21, which includes our Matrix-M adjuvant, has been advanced through a Phase IIb clinical trial conducted in a study population of 450 children, ages 5 to 17 months. In April this year, we announced a publication of the data from this trial in Preprints with The Lancet, where R21 demonstrated 77% efficacy.

我們還希望強調在瘧疾預防方面取得重要進展的激動人心的合作。牛津大學的瘧疾候選疫苗 R21（包括我們的 Matrix-M 佐劑）已通過在 450 名 5 至 17 個月的兒童研究人群中進行的 IIb 期臨床試驗取得進展。今年 4 月，我們在《柳葉刀》的 Preprints 中公佈了這項試驗的數據，其中 R21 顯示了 77% 的療效。

These landmark results underscore the potential for this vaccine to serve as a tool to help control malaria globally. Clinically -- clinical development of this vaccine candidate continues with a Phase III licensure trial underway in 4 countries in Africa to evaluate the safety and efficacy of R21 in 4,800 participants, ages 5 to 36 months.

這些具有里程碑意義的結果強調了這種疫苗作為幫助控制全球瘧疾的工具的潛力。臨床上——該候選疫苗的臨床開發繼續在非洲 4 個國家進行 III 期許可試驗，以評估 R21 在 5 至 36 個月的 4,800 名參與者中的安全性和有效性。

We look to the commercial potential of this vaccine and we supply Matrix-M adjuvant to the component to Serum Institute of India, who will manufacture the R21 vaccine. In efforts to ensure widespread distribution, Serum Institute has granted rights to use -- has been granted rights to use Matrix-M adjuvant in the vaccine in endemic regions and will pay Novavax royalties on its market sales of the vaccine. Novavax will have rights to sell and distribute the vaccine to travelers in military vaccine markets.

我們期待這種疫苗的商業潛力，並向印度血清研究所提供 Matrix-M 佐劑佐劑，該研究所將生產 R21 疫苗。為了確保廣泛分發，血清研究所已授予使用權——已被授予在流行地區在疫苗中使用 Matrix-M 佐劑的權利，並將為其疫苗的市場銷售支付 Novavax 特許權使用費。 Novavax 將有權向軍用疫苗市場的旅行者銷售和分發疫苗。

With that, I'd like to turn it over to John to discuss our key supply developments for the quarter.

有了這個，我想把它交給約翰來討論我們本季度的主要供應發展。

Thanks, Greg. Turning to Slide 15. You can see a snapshot of our global supply commitments to date as well as our licensing agreements. With this as a backdrop, let me state that in the quarter, we saw that the urgency to make 2373 available globally only intensified amidst the backdrop of the evolving COVID-19 pandemic. Today, there continues to be a vast need for equitable distribution of COVID-19 vaccine.

謝謝，格雷格。轉到幻燈片 15。您可以看到我們迄今為止的全球供應承諾以及我們的許可協議的快照。以此為背景，讓我聲明，在本季度，我們看到在全球範圍內提供 2373 的緊迫性只會在不斷演變的 COVID-19 大流行的背景下加劇。今天，仍然非常需要公平分配 COVID-19 疫苗。

While the U.S. has fully vaccinated 35% of all adults greater than 18 years of age, demand outside the U.S. far outpaces supply. This unmet demand across the globe reinforces the importance of bringing our vaccine to market and has resulted in continued demand for 2373 now and through 2022, which we believe reflects the continued confidence in 2373's ability to combat the pandemic.

雖然美國已為 35% 的 18 歲以上成年人完全接種疫苗，但美國以外的需求遠遠超過供應。全球這種未得到滿足的需求加強了將我們的疫苗推向市場的重要性，並導致現在和 2022 年對 2373 的持續需求，我們認為這反映了對 2373 抗擊大流行的能力的持續信心。

Our commitment to the principles of fair and equitable access to 2373 that includes supplying vaccine to low-, middle- and high-income countries remains at the core of our values. In light of this, we were happy to announce last week the finalization of an advanced purchase agreement with Gavi, expanding upon our memorandum of understanding announced in February. Under the agreement, we have committed cumulative 1.1 billion doses of 2373 through the COVAX facility. We expect to manufacture and distribute 350 million of these doses, utilizing antigen and adjuvant manufactured at facilities directly funded by previous investments from CEPI.

我們對公平和公平獲得 2373 原則的承諾，包括向低收入、中等收入和高收入國家提供疫苗，仍然是我們價值觀的核心。有鑑於此，我們很高興上周宣布與 Gavi 敲定了一項預購協議，擴展了我們在 2 月宣布的諒解備忘錄。根據協議，我們已通過 COVAX 設施累計提供 11 億劑 2373 劑。我們預計將利用由 CEPI 先前投資直接資助的設施生產的抗原和佐劑製造和分發 3.5 億劑這些劑量。

Under a separate agreement with Gavi, Serum Institute will manufacture and distribute Novavax licensed product for the remaining balance of the 1.1 billion doses for low- and middle-income countries participating in the COVAX facility. Together with Serum, we expect to begin delivery of doses in the third quarter of 2021, dependent on the appropriate regulatory authorizations.

根據與 Gavi 的單獨協議，血清研究所將為參與 COVAX 設施的低收入和中等收入國家生產和分發 Novavax 許可產品，用於剩餘的 11 億劑疫苗。與 Serum 一起，我們預計將在 2021 年第三季度開始交付劑量，具體取決於適當的監管授權。

In the first quarter, we also finalized an advanced purchase agreement with the Government of Canada to supply 52 million doses with the option to purchase an additional 24 million doses. We also announced our intention to transfer our technology and partner with the Government of Canada to explore opportunities to manufacture our vaccine at the National Research Council's Biologics Manufacturing Center.

在第一季度，我們還與加拿大政府敲定了一項預購協議，提供 5200 萬劑疫苗，並可選擇額外購買 2400 萬劑疫苗。我們還宣布我們打算轉讓我們的技術並與加拿大政府合作，以探索在國家研究委員會的生物製品製造中心生產我們的疫苗的機會。

As of today, in addition to our advanced purchase agreements with Gavi, our bilateral advanced purchase agreements total approximately 200 million doses committed to countries around the globe. In addition, we continue negotiations with the European Commission on behalf of the 27-member states for a potential supply agreement. We are pleased with our progress to date, and we will share additional details as these discussions reach finalization.

截至今天，除了我們與 Gavi 的預購協議外，我們的雙邊預購協議總計約 2 億劑，承諾向全球各國提供。此外，我們繼續代表 27 個成員國與歐盟委員會就潛在的供應協議進行談判。我們對迄今為止的進展感到滿意，隨著這些討論的最終確定，我們將分享更多細節。

Based on the many inquiries over the past year and those ongoing discussions, we understand that the COVID-19 pandemic and demand for vaccine is here to stay. We will continue to support this demand in the years to come. As such, we are currently negotiating a number of other supply agreements with countries globally that are looking to secure a vaccine for 2022 and beyond. Given the need to complete the primary vaccination in most countries, the demand for 2373 remains extremely high.

根據過去一年的許多詢問和正在進行的討論，我們了解到 COVID-19 大流行和對疫苗的需求將持續存在。我們將在未來幾年繼續支持這一需求。因此，我們目前正在與全球尋求在 2022 年及以後獲得疫苗的國家談判其他一些供應協議。鑑於大多數國家需要完成初級疫苗接種，對 2373 的需求仍然非常高。

With that, I would now like to turn to Slide 16 to review our financial results. Today, we issued our first quarter earnings release, which walks through the details of our financial results for the quarter. We also filed our 10-Q for the first quarter of 2021 today. This includes details on important business and financing events, during and subsequent to the first quarter.

有了這個，我現在想轉向幻燈片 16 來回顧我們的財務業績。今天，我們發布了第一季度收益報告，其中詳細介紹了我們本季度的財務業績。我們今天還提交了 2021 年第一季度的 10-Q。這包括第一季度期間和之後的重要業務和融資事件的詳細信息。

Notably, Novavax revenue in the first quarter of 2021 was $447 million compared to $3 million in the same period in 2020. This significant increase was due to the increase in research and development expenses to $593 million relating to the 2373 activities performed under the U.S. government and CEPI funding agreements. We raised net proceeds of approximately $565 million during the first quarter through utilization of our ATM offerings.

值得注意的是，Novavax 2021 年第一季度的收入為 4.47 億美元，而 2020 年同期為 300 萬美元。這一顯著增長是由於與美國政府開展的 2373 項活動相關的研發費用增加至 5.93 億美元和 CEPI 資助協議。通過利用我們的 ATM 產品，我們在第一季度籌集了大約 5.65 億美元的淨收益。

The quarter ended with a very strong cash position of over $2 billion compared to over $800 million at year-end 2020. This increase in cash was primarily due to $772 million of payments received under advanced purchase agreements and the $565 million of ATM funding just referenced.

本季度末現金狀況非常強勁，超過 20 億美元，而 2020 年底時超過 8 億美元。現金增加的主要原因是根據預先購買協議收到的 7.72 億美元付款以及剛剛提到的 5.65 億美元的 ATM 資金.

With that, I'd like to hand it over to Stan to discuss some of our updated timing and guidance as it relates to our upcoming lifestyles.

有了這個，我想把它交給斯坦來討論我們更新的時間和指導，因為它與我們即將到來的生活方式有關。

Thanks, John. Okay. So let's turn to slide 17. And on this call, we've reviewed a long list of recent successes, including their clinical safety and efficacy data. Now I'd like to talk about the near and midterm focus of the company. And I'd like to start by addressing the questions that we get asked every single day with the goal of updating our guidance for the short term.

謝謝，約翰。好的。讓我們轉到第 17 張幻燈片。在這次電話會議上，我們回顧了一系列近期成功案例，包括其臨床安全性和有效性數據。現在我想談談公司的近期和中期重點。我想首先解決我們每天被問到的問題，目的是更新我們的短期指導。

First question we always get is when can we expect to see the results from the U.S. Phase III efficacy trial? The second is what is the timetable of regulatory filings in the various parts of the world? And the third is what is the trajectory for scaling up our manufacturing on a global basis? Let me take them one at a time.

我們總是遇到的第一個問題是，我們什麼時候可以看到美國 III 期療效試驗的結果？二是全球各地監管備案的時間表是怎樣的？第三是在全球範圍內擴大我們的製造業的軌跡是什麼？讓我一個接一個。

Unblinding U.S. Phase III trial -- let's start with the timing of the U.S. Phase III trial. So please turn to Slide 18. We have previously guided that we expect to unblind the trial in the second quarter of this year. And based on the timing of the unblinding of our South African and U.K. trials, I think that a lot of people have an expectation that we might be able to unblind the trial in April. But instead, we initiated a blinded crossover in this trial in April for which we show the study design on the slide.

揭開美國 III 期試驗的盲區——讓我們從美國 III 期試驗的時間開始。所以請轉到幻燈片 18。我們之前曾指導我們預計在今年第二季度揭盲試驗。根據我們在南非和英國試驗揭盲的時間，我認為很多人都期望我們能夠在 4 月份揭盲。但相反，我們在 4 月份的這項試驗中啟動了盲法交叉，我們在幻燈片上展示了研究設計。

We believe implementing the crossover and thus bypassing an interim unblinding will actually give us a comprehensive data set more quickly. This gives us the ability to collect more cases, increasing the robustness of our data set when measuring efficacy against factors such as severe disease and against variants. We continue to guide that we will announce our Phase III clinical data in the second quarter. We look forward to sharing our results with you in a few weeks.

我們相信實施交叉並因此繞過臨時揭盲實際上將更快地為我們提供全面的數據集。這使我們能夠收集更多病例，在衡量針對嚴重疾病和變異等因素的功效時，提高我們數據集的穩健性。我們繼續指導我們將在第二季度公佈我們的 III 期臨床數據。我們期待在幾週內與您分享我們的結果。

So with respect to regulatory authorizations, moving now to Slide 19. Our timetable for regulatory filings, we know that we're delayed from where we thought we'd be at this point. But now we're giving guidance that nearly all of the major challenges have been overcome and we can clearly see the light at the end of the tunnel. All facilities in our network have already demonstrated the ability to manufacture commercial scale GMP material. The filing timetable depends on completing the final phases of qualification and validation of the assays that are needed to complete the demonstration of process consistency and to subsequently finalize the reports for regulatory filing.

因此，關於監管授權，現在轉到第 19 張幻燈片。我們的監管備案時間表，我們知道我們現在已經推遲了我們認為的時間。但現在我們給出的指導是，幾乎所有主要挑戰都已克服，我們可以清楚地看到隧道盡頭的曙光。我們網絡中的所有設施都已經展示了生產商業規模 GMP 材料的能力。提交時間表取決於完成鑑定和驗證的最後階段，這些階段是完成工藝一致性證明和隨後完成監管備案報告所需的。

It has been a massive effort and has dependent on our global manufacturing partners to help us accumulate a suitable data package. And not surprisingly, it is currently the top priority of the company. It is not likely that we'll finish this work in time to submit by the end of June, so I'm changing our guidance to reflect that we expect to complete our regulatory filings in the third quarter. We are planning multiple filings that will be made with the U.S. FDA, the U.K. MHRA and with the EU EMA as soon as our data packages are complete.

這是一項巨大的努力，並且依賴於我們的全球製造合作夥伴來幫助我們積累合適的數據包。毫不奇怪，這是目前公司的重中之重。我們不太可能在 6 月底前按時完成這項工作，因此我正在更改我們的指導以反映我們預計將在第三季度完成監管備案。我們計劃在我們的數據包完成後立即向美國 FDA、英國 MHRA 和歐盟 EMA 提交多份文件。

In other markets, we will continue our rolling review processes initiated earlier this year, including with Health Canada, Australian Therapeutic Goods Administration and New Zealand MedSafe. Additionally, we anticipate starting rolling submissions to WHO for emergency use listing. A rolling submission process is also underway with the Republic of Korea's Ministry of Food and Drug Safety, which SK Bioscience initiated in collaboration with Novavax in April of this year.

在其他市場，我們將繼續我們今年早些時候啟動的滾動審查流程，包括與加拿大衛生部、澳大利亞治療用品管理局和新西蘭 MedSafe 的合作。此外，我們預計開始向世衛組織滾動提交緊急用途清單。今年 4 月，SK Bioscience 與 Novavax 合作發起了與韓國食品藥品安全部的滾動提交程序。

These regulatory authorities will all complete their reviews of our submissions on their own timetables and we hope to have market authorizations in multiple countries during the third quarter. As of today, we are not able to predict a date with precision, so we won't. It is in everybody's interest to push to make this happen as early in the quarter as possible.

這些監管機構都將在他們自己的時間表上完成對我們提交的審查，我們希望在第三季度在多個國家獲得市場授權。截至今天，我們無法準確預測日期，所以我們不會。推動在本季度儘早實現這一目標符合每個人的利益。

Let me next discuss the current state of our manufacturing and our anticipated capacity as we look to the remainder of the year. Please turn to Slide 20. On our last earnings call, we discussed the significant strides taken in 2020 to build out our global supply chain as seen on our global supply chain map. Some of the key manufacturing developments included reaching an agreement in principle with GSK to support fill and finish manufacturing of up to 60 million doses for use in the U.K., establishing manufacturing capabilities in Canada through our memorandum of understanding with the Canadian government to produce 2373 at the National Research Council's Biologics Manufacturing Center, finalizing exclusive license agreements with both Takeda and SK Bioscience in Japan and South Korea respectively.

接下來讓我討論一下我們的製造現狀和我們對今年剩餘時間的預期產能。請轉到幻燈片 20。在我們上次的財報電話會議上，我們討論了 2020 年在構建全球供應鏈方面取得的重大進展，如我們的全球供應鏈地圖所示。一些關鍵的製造發展包括與葛蘭素史克（GSK）達成原則性協議，以支持在英國使用的多達 6000 萬劑的灌裝和完成製造，通過我們與加拿大政府的諒解備忘錄在加拿大建立製造能力，以生產 2373國家研究委員會的生物製劑製造中心，分別與武田和 SK Bioscience 在日本和韓國敲定獨家許可協議。

Today, our global supply chain now spans over 10 countries with all of our manufacturing sites producing GMP material at scale. I think we've done a remarkable job of standing up manufacturing in these multiple plants across the globe. I'm happy to report that we have got to the point where we've successfully manufactured our drug substance, a recombinant protein nanoparticle, at commercial scale in each of these plants. The drug substance production is the most complicated step in the overall manufacturing processes.

今天，我們的全球供應鏈現已跨越 10 多個國家/地區，我們所有的生產基地都在大規模生產 GMP 材料。我認為我們在全球多個工廠的製造方面做得非常出色。我很高興地報告，我們已經成功地在這些工廠中以商業規模生產了我們的藥物物質，一種重組蛋白納米顆粒。原料藥生產是整個生產過程中最複雜的步驟。

Our guidance has been that we would be at full operating cadence by the end of the third quarter. As has been fairly widely reported, we are having difficulty getting to that point due to a global shortage of a few raw materials, including a shortage of 2,000-liter bags, depth filters, which are used in the purification process and then growth media. As closely as we try to manage these materials, we have been running into shortages that has cost us to delay production runs.

我們的指導是，我們將在第三季度末達到全面的運營節奏。正如廣泛報導的那樣，由於全球範圍內一些原材料短缺，包括用於純化過程和生長培養基的 2,000 升袋、深度過濾器的短缺，我們很難達到這一點。在我們努力管理這些材料的同時，我們一直遇到短缺，導致我們不得不推遲生產運行。

Our expectation is that our suppliers are adding sufficient capacity such that we will be operating at full capacity, but likely not until the fourth quarter. We expect we will be at full capacity throughout 2022 and beyond. The impact on us will be a somewhat slower rollout on product approval, but not dramatically. We are building inventory of our drug substance and the adjuvant as we speak. We have tens of millions of doses made already and will continue to produce approximately 100 million doses per month by the end of the third quarter. These will be ready to go and when we get our regulatory authorizations.

我們的預期是，我們的供應商正在增加足夠的產能，以便我們能夠滿負荷運營，但可能要到第四季度。我們預計我們將在 2022 年及以後滿負荷運轉。對我們的影響將是產品批准的推出速度稍慢，但不會顯著。正如我們所說，我們正在建立我們的原料藥和佐劑的庫存。我們已經生產了數千萬劑，到第三季度末將繼續每月生產約 1 億劑。當我們獲得監管授權時，這些將準備就緒。

So now let's turn to slide 21. Let's look at the next 6 to 12 months. With licensure expected in the third quarter, at least in some parts of the world, we will begin shipping product. With our new agreement with Gavi and the COVAX facility, our doses over the next 6 to 12 months may be prioritized to lower-priced countries. We have taken this position because we think it's the right thing to do and is in line with our original funding from CEPI. I think that it's particularly timely given the discussion around the waivers of IP rights during the pandemic.

所以現在讓我們轉到幻燈片 21。讓我們看看接下來的 6 到 12 個月。預計在第三季度獲得許可，至少在世界某些地區，我們將開始運送產品。隨著我們與 Gavi 和 COVAX 設施的新協議，我們在未來 6 到 12 個月內的劑量可能會優先用於價格較低的國家。我們採取這一立場是因為我們認為這是正確的做法，並且符合我們最初從 CEPI 獲得的資金。我認為考慮到在大流行期間圍繞放棄知識產權的討論特別及時。

I believe that we have taken the lead to show the world the right way to get product distributed on an equitable basis globally. We expect that even with early products sold at low prices, we will be able to match that with revenue from higher income countries to be able to generate sufficient cash flow to expand our business rapidly.

我相信我們已經帶頭向世界展示了在全球公平分配產品的正確方法。我們預計，即使早期產品以低價出售，我們也將能夠與來自高收入國家的收入相匹配，從而能夠產生足夠的現金流來快速擴展我們的業務。

Beginning in early 2022, we will have a rapid increase in our ability to service our high-income country APAs because of the following reasons: reaching manufacturing capacity of over 150 million doses per month starting in the fourth quarter of this year, including from Serum Institute; increased capacity coming from online, from new manufacturing partners and resolution of any outstanding raw material constraints.

從 2022 年初開始，我們為高收入國家的 APA 提供服務的能力將迅速提高，原因如下：從今年第四季度開始，包括 Serum 在內的生產能力達到每月超過 1.5 億劑研究所;來自在線、新的製造合作夥伴的產能增加以及任何未解決的原材料限制的解決。

With respect to the U.S. market, we are well positioned with our technology and timing to supply product for boosting and seasonal revaccination. In the ex-U.S. market, there continues to be variability with many countries continuing to have very low vaccination rates. Therefore, significant unmet demand remains globally that we will be able to support 2022 and beyond. This will continue to include the supply to high-income markets from our facilities, and we expect low and middle-income countries to be supported by Serum.

對於美國市場，我們在技術和時機方面處於有利地位，可以提供用於促進和季節性再接種的產品。在前美國市場上，仍然存在差異，許多國家的疫苗接種率仍然非常低。因此，全球仍有大量未滿足的需求，我們將能夠支持到 2022 年及以後。這將繼續包括我們的設施向高收入市場的供應，我們預計低收入和中等收入國家將得到 Serum 的支持。

Over the next 4 to 6 quarters, we expect all of these factors to contribute to Novavax generating billions of dollars of revenue. We plan to be in the clinic with our variant strain antigen in the fall and data will come soon after that. We can then determine our best path forward for our booster or revaccination strategy. That strategy will be dependent on durability of protection and ongoing variant strain surveillance. We'll sort that out and make the right call at that time.

在接下來的 4 到 6 個季度，我們預計所有這些因素都將為 Novavax 創造數十億美元的收入做出貢獻。我們計劃在秋天帶著我們的變異株抗原進入臨床，之後很快就會有數據。然後，我們可以確定我們的加強或再接種策略的最佳前進路徑。該策略將取決於保護的持久性和持續的變異菌株監測。我們會解決這個問題並在那個時候做出正確的決定。

Longer term, we expect to upgrade our vaccine to be combined with flu, which will require further expansion of our production capability, which is something we think our platform is unique in being able to do. We initiated this program late last year and published data last week showing that in an animal model or combination NanoFlu COVID vaccine was able to elicit strong antibody levels to both flu and the coronavirus. And when the animals were challenged with coronavirus, they are completely protected. This has the potential to be the standard for seasonal respiratory vaccines.

從長遠來看，我們希望升級我們的疫苗以結合流感，這將需要進一步擴大我們的生產能力，我們認為我們的平台能夠做到這一點是獨一無二的。我們去年年底啟動了這個項目，上周公布的數據顯示，在動物模型或 NanoFlu COVID 疫苗組合中，能夠引發針對流感和冠狀病毒的強抗體水平。當這些動物受到冠狀病毒的攻擊時，它們得到了完全的保護。這有可能成為季節性呼吸道疫苗的標準。

With a single vaccination using our same platform, we could have a vaccine that elicits broadly neutralizing antibodies, is efficacious against both coronavirus and flu, is stable, and can be made and formulated at large scale. That would require running trials with the combination COVID flu vaccine. That's been hard for us to start up because we haven't had the benefit of our own production capabilities and our contractors are all focused on COVID. But we will be able to get a combo vaccine into patients' arms by the end of this year. Just to confirm that the formulation has affected us apart, I would guide people to think about the launch of such a combo vaccine out in 2025.

通過使用我們相同的平台進行單次疫苗接種，我們可以獲得一種能引發廣泛中和抗體、對冠狀病毒和流感均有效、穩定且可以大規模生產和配製的疫苗。這將需要對聯合 COVID 流感疫苗進行試驗。這對我們來說很難啟動，因為我們沒有從我們自己的生產能力中受益，而且我們的承包商都專注於 COVID。但我們將能夠在今年年底前將一種組合疫苗送入患者的懷抱。只是為了確認這種配方對我們產生了影響，我會引導人們考慮在 2025 年推出這種組合疫苗。

So even if you see other well tolerated protein adjuvanted vaccines compete with us for the COVID-only market in the next several years, we think that our unique COVID flu combo will come out on top in the long run. In the future, as we generate significant revenue in our production facilities come online, you'll see us use our capital, our people and the labs to produce more vaccine programs that our team has long been hoping to work on. This is just the beginning for Novavax.

因此，即使您看到其他耐受性良好的蛋白質佐劑疫苗在未來幾年內與我們競爭僅 COVID 市場，我們認為從長遠來看，我們獨特的 COVID 流感組合將脫穎而出。將來，隨著我們的生產設施上線產生可觀的收入，您將看到我們利用我們的資金、我們的人員和實驗室來生產我們團隊長期以來一直希望開展的更多疫苗項目。這只是 Novavax 的開始。

In all cases, we will continue to build these vaccines on the platform that has consistently shown competitive advantages, including the development of broadly neutralizing antibodies with the potential to protect against a wider range of variants, both in COVID and in flu, a stability profile that allows for the refrigerated shipment of storage of vaccine, a safety profile that leads to fewer side effects and with our combination vaccine, the potential to protect against multiple infectious diseases with a single vaccination.

在所有情況下，我們將繼續在始終顯示出競爭優勢的平台上構建這些疫苗，包括開發廣泛的中和抗體，以防止 COVID 和流感中更廣泛的變體，穩定性概況這允許冷藏運輸疫苗，這種安全性可以減少副作用，並且使用我們的聯合疫苗，可以通過一次疫苗接種來預防多種傳染病。

Turning finally to Slide 22. With another successful quarter, strengthening every aspect of our business, we are rapidly advancing toward our mission of delivering 2373 globally. With that being said, we recognize the need to seamlessly deliver on our more near-term milestones ahead, including executing in our clinical trials, finalizing preparations to ready our global supply for commercialization, obtaining regulatory authorizations for 2373 and advancing our variant strain in combination vaccines in the clinical development to most effectively address the evolving pandemic.

最後轉到幻燈片 22。隨著又一個成功的季度，加強了我們業務的各個方面，我們正在迅速朝著我們在全球交付 2373 的使命前進。話雖如此，我們認識到需要無縫地實現我們未來更近期的里程碑，包括執行我們的臨床試驗、完成準備工作以準備我們的全球供應以進行商業化、獲得 2373 的監管授權以及推進我們的變異菌株組合臨床開發中的疫苗，以最有效地應對不斷發展的大流行。

Before opening up the call to Q&A, I want to thank our entire Novavax team for their continued dedication and tireless efforts over what was once again a very busy and productive quarter. These efforts, combined with the support of our partners globally, have brought Novavax significantly closer to delivering our COVID-19 vaccine.

在打開問答電話之前，我要感謝我們整個 Novavax 團隊在這個又一次非常繁忙和富有成效的季度中的持續奉獻和不懈努力。這些努力，加上我們全球合作夥伴的支持，使 Novavax 離交付我們的 COVID-19 疫苗更近了一步。

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

我現在將其交給接線員進行問答。

(Operator Instructions) The first question comes from Kelechi Chikere with Jefferies.

（操作員說明）第一個問題來自 Kelechi Chikere 和 Jefferies。

Just a couple on my end. I guess, first, can you give us an idea or additional color on how much vaccine that you have actually stockpiled? And I guess also related to that, how much are you actually producing per month currently?

我這邊只有一對。我想，首先，你能給我們一個關於你實際儲存了多少疫苗的想法或額外的顏色嗎？我想也與此相關，您目前每月實際生產多少？

Yes, it's a good question. This is Stan. And it varies quite dramatically by site, by month as we either have raw material supplies or not. We -- as I mentioned to you that in the third quarter, we had expected to be able to produce roughly 70 million or 80 million doses per month at the Novavax sites, excluding Serum. And I would guess that we're probably in half that right now. We've made 30 million or 40 million doses on the shelf and it's getting larger every week.

是的，這是一個很好的問題。這是斯坦。由於我們是否有原材料供應，不同地點和月份的差異很大。我們 - 正如我向您提到的那樣，在第三季度，我們預計在 Novavax 站點每月能夠生產大約 7000 萬或 8000 萬劑，不包括 Serum。我猜我們現在可能只有一半。我們已經在貨架上生產了 3000 萬或 4000 萬劑，而且每週都在增加。

The next question comes from Charles Duncan with Cantor Fitzgerald.

下一個問題來自查爾斯·鄧肯和康托·菲茨杰拉德。

Team, congrats on a good quarter of progress. Thanks for taking my questions. I have a couple of them. The first is, I'm wondering if you can provide any additional color on the U.K. emergency use authorization? And then secondarily, maybe a perspective on emergency use authorizations versus, say, full authorization. I guess, I'm wondering, do you prefer to stick with an EUA approach for countries outside the U.K. and others that you filed? Or would you pursue a full authorization?

團隊，祝賀取得了良好的季度進展。感謝您提出我的問題。我有幾個。首先是，我想知道你是否可以在英國緊急使用授權上提供任何額外的顏色？其次，也許是關於緊急使用授權與完全授權的觀點。我想，我想知道，您是否更願意為英國以外的國家和您提交的其他國家堅持 EUA 方法？還是您會尋求完全授權？

Okay. Yes. So U.K. -- U.K. has been -- we've worked closely with a lot of these groups. U.K. we've had the most dialogue with and I think the expectation we had -- always had was that we would try to get a filing into the U.K. with the full CMC and clinical package by the end of June. That's now moved into July. I think the MHRA is paying close attention and is likely to be the first approval and authorization, I guess, is the right word. And so it could be others like Korea just at the same time, I think.

好的。是的。所以英國——英國一直——我們與很多這樣的團體密切合作。我們與英國進行了最多的對話，我認為我們一直以來的期望是，我們將嘗試在 6 月底之前向英國提交完整的 CMC 和臨床方案。現在已經移到七月了。我認為 MHRA 正在密切關注，並且很可能是第一個批准和授權，我猜是正確的詞。因此，我認為可能同時是像韓國這樣的其他國家。

And just as far as the EUA versus final approval, we think that emergency use of conditional authorization is on the route to getting full approval. And that's just because the safety data needs to mature to have a complete package to allow for final approval.

就 EUA 與最終批准而言，我們認為緊急使用有條件授權正在獲得完全批准。這只是因為安全數據需要成熟才能擁有完整的軟件包以進行最終批准。

Yes. So everything we're putting in for the EUA is relevant to the BLA.

是的。因此，我們為 EUA 所做的一切都與 BLA 相關。

And then moving on to PREVENT-19. In terms of the crossover, could you just help me think through kind of the strategy there? It seems like the crossover eliminates the control arm. And I'm just really wondering what you're hoping to learn from the crossover? Or is it just a way to increase the number of patients that have been exposed to full -- fully vaccinated?

然後轉到 PREVENT-19。在交叉方面，你能幫我想想那裡的策略嗎？似乎交叉消除了控制臂。我只是想知道你希望從交叉中學到什麼？或者它只是一種增加完全接種疫苗的患者數量的方法？

Yes. So the situation in the PREVENT-19 study was complicated by the fact that a lot of emergency use vaccine was made available in the U.S. and the U.S. public health system was advocating its use. So for us to maintain the integrity of the study, we had to take on a strategy where we would provide vaccine to all the participants. And the most rational way to do that would be through a crossover. This allows us to also look at waning of protection by comparing the people who are initially vaccinated with those that are vaccinated in the crossover design. We're going to get a lot of information from the study, including a larger safety database. But importantly, we are going to have enough cases, as Stan reported, prior to crossover for us to be able to have a final analysis in the second quarter.

是的。因此，PREVENT-19 研究的情況因美國提供了許多緊急使用疫苗而美國公共衛生系統提倡使用這一事實而變得複雜。因此，為了保持研究的完整性，我們必須採取一種策略，為所有參與者提供疫苗。最合理的方法是通過交叉。這使我們還可以通過比較最初接種疫苗的人和在交叉設計中接種疫苗的人來觀察保護的減弱情況。我們將從這項研究中獲得大量信息，包括一個更大的安全數據庫。但重要的是，正如斯坦報告的那樣，在交叉之前，我們將有足夠的案例，以便我們能夠在第二季度進行最終分析。

Okay. Final question regarding perhaps the future strategy of combining COVID vaccine with an influenza vaccine or NanoFlu. I think Stan, you mentioned perhaps being able to market that in 2025. I'm wondering what are the rate-limiting steps to getting there. And we've got several seasons beforehand and it seems like that would be a pretty interesting combination of vaccines. So what needs to be done to get there?

好的。最後一個問題可能是關於未來將 COVID 疫苗與流感疫苗或 NanoFlu 結合的策略。我認為 Stan，您提到可能會在 2025 年將其推向市場。我想知道到達那裡的限速步驟是什麼。而且我們已經提前了幾個賽季，看起來這將是一個非常有趣的疫苗組合。那麼需要做什麼才能到達那裡？

Well, it's generally clinical development, but…

嗯，這通常是臨床開發，但是......

I'll take a crack at it there. There are a couple of issues. One of them is if you've been watching the influenza epidemiology, you will have seen that flu has disappeared this season. And we need to understand how it's going to turn back to its normal cadence before we plan to do any kind of efficacy evaluation, naturally only in our own studies where we think we can get a result. And for that, we need to understand when flu comes back and how it will come back. So that's an important bit of information we need because we need to compare the combination vaccine to the 2 individual components. We'll get the efficacy results for COVID, while we already have them from the U.K. and South Africa. And we'll get confirmation from the final Phase III study in the U.S., but we also need efficacy results from the NanoFlu so we can use it to leverage the combination product.

我會在那裡破解它。有幾個問題。其中之一是，如果你一直在關注流感流行病學，你會發現流感在這個季節已經消失了。在我們計劃進行任何形式的功效評估之前，我們需要了解它將如何恢復到正常節奏，自然只有在我們認為可以得到結果的我們自己的研究中。為此，我們需要了解流感何時復發以及如何復發。這是我們需要的重要信息，因為我們需要將聯合疫苗與兩種單獨的成分進行比較。我們將獲得針對 COVID 的療效結果，而我們已經從英國和南非獲得了這些結果。我們將從美國最後的 III 期研究中得到確認，但我們還需要 NanoFlu 的療效結果，以便我們可以使用它來利用組合產品。

Do you anticipate a trial -- I think you had mentioned of a trial perhaps even starting this next flu season for the Northern Hemisphere or the follow not?

您是否預計會進行試驗——我想您已經提到過試驗甚至可能會在北半球的下一個流感季節開始，還是不跟隨？

Immunogenicity trial.

免疫原性試驗。

So it’s immunogenicity trial starting in the fall.

所以它的免疫原性試驗從秋季開始。

The next question comes from Eric Joseph with JPMorgan.

下一個問題來自摩根大通的 Eric Joseph。

First, on manufacturing, Stan, if I heard correctly, you have 30 million to 40 million doses on the shelf currently. That would seem or sound well below the target of 110 million doses by the end of the quarter to satisfy OWS. So I'm just wondering what the impact might be to remittance or follow through on that award, whether any of that payment is at risk?

首先，在製造方面，Stan，如果我沒聽錯的話，目前貨架上有 3000 萬到 4000 萬劑。這似乎或聽起來遠低於到本季度末滿足 OWS 的 1.1 億劑的目標。所以我只是想知道匯款或兌現該裁決可能會產生什麼影響，是否有任何付款存在風險？

Secondly, on PREVENT-19, it sounds like you had some visibility on a net accrual rate in initiating the crossover trial portion. Can you just say clearly whether or not you've already conducted an interim efficacy analysis or pretty much what prompted the move to initiate the crossover portion of the study at that time?

其次，在 PREVENT-19 上，聽起來您在啟動交叉試驗部分時對淨應計率有一定的了解。您能否清楚地說明您是否已經進行了中期療效分析，或者幾乎是什麼促使當時啟動研究的交叉部分？

And then finally, given some of the challenges in sourcing of raw materials to complete manufacturing, how should we be thinking about the impact to product margins from where things stood at the beginning of the year?

最後，考慮到從原材料採購到完成製造的一些挑戰，我們應該如何考慮從年初的情況來看對產品利潤率的影響？

Yes. Let me take the manufacturing-related ones. I think that U.S., we -- I think our expectation is we'll have the 110 million doses made right around the end of the year, the first/second month of next year. So that will take that. The impact of cost of goods sold is -- it's not a long-term impact at all. I think it's -- if you're not running a plant, the first product you make costs a lot. But if you're making a regular cadence, the cost of goods sold should be where it always is. And so I'm not worried about our cost of goods sold margins.

是的。讓我拿製造相關的那些。我認為美國，我們 - 我認為我們的期望是我們將在今年年底，明年的第一/第二個月左右生產 1.1 億劑疫苗。所以這將採取那個。銷售成本的影響是——根本不是長期影響。我認為是——如果你不經營工廠，你生產的第一個產品成本很高。但是，如果您有規律的節奏，那麼所售商品的成本應該始終保持不變。所以我不擔心我們的商品銷售成本利潤率。

And as far as the crossover, like I mentioned before, the real reason we did it was because EUA vaccine came available. In our other studies, for instance our Phase II studies, about 60% of the people have dropped out to receive EUA vaccine. So that was the real driver for us to maintain the integrity of the study.

至於交叉，就像我之前提到的那樣，我們這樣做的真正原因是因為 EUA 疫苗可用。在我們的其他研究中，例如我們的 II 期研究，大約 60% 的人已經退出接受 EUA 疫苗。所以這是我們保持研究完整性的真正動力。

Okay. I mean, really just a follow-up on Charles' question, it seemed like that might sort of invalidate the placebo arm. Do you -- I guess, what proportion of patients from the study have -- do you expect to cross over? Are you -- how do you maintain confidence that you'll still be able to accrue the dose primarily on the placebo arm?

好的。我的意思是，實際上只是對查爾斯問題的跟進，似乎這可能會使安慰劑組無效。你——我猜，研究中的患者比例有多少——你是否希望跨越？你——你如何保持信心，你仍然能夠主要在安慰劑臂上累積劑量？

The primary efficacy is obviously conducted prior to crossover where there's a placebo comparator. And that's going to be the final analysis. We didn't conduct an interim -- this can be a single analysis. It can be conducted on a data set. All of our alpha is going to be used against that endpoint. So we're going to have a more precise estimate of efficacy. And that data will be available before the end of this quarter.

主要功效顯然是在有安慰劑比較器的交叉之前進行的。這將是最終的分析。我們沒有進行臨時分析——這可以是一個單一的分析。它可以在數據集上進行。我們所有的 alpha 都將用於該端點。因此，我們將對功效進行更精確的估計。該數據將在本季度末之前提供。

The next question comes from Mayank Mamtani with B. Riley FBR.

下一個問題來自 Mayank Mamtani 和 B. Riley FBR。

Appreciate the comprehensive update. My questions are mostly the specific follow-ups to previously-asked questions. So maybe just, Stan, starting from the nonclinical CMC manufacturing components of the submission, are you able to comment on what might be these sort of things that are causing the holdup? Is it just process coordinating between the different sites? Or are there any specific issues around any particular assay? So if you're able to comment on that, that would be great.

欣賞全面更新。我的問題主要是對先前提出的問題的具體跟進。所以也許只是，Stan，從提交的非臨床 CMC 製造組件開始，你能評論一下可能是什麼導致了滯留嗎？它只是在不同站點之間進行過程協調嗎？或者是否存在圍繞任何特定分析的任何具體問題？因此，如果您能夠對此發表評論，那就太好了。

No. I mean, and part of it has to do with manufacturing at different sites and showing comparability between the processes and the actual end product between the different sites. And you have to develop assays that can follow those. And so I think it probably took a little longer than we expected to get a potency assay that was worked across -- told the same story across all the sites. But I'm happy to say we did. We've crossed that bridge. We're -- we made a big breakthrough there and we're now racing towards validating everything and putting it into a package.

不，我的意思是，其中一部分與在不同地點的製造以及顯示不同地點之間的流程和實際最終產品之間的可比性有關。你必須開發可以遵循這些的分析。所以我認為它可能比我們預期的要花更長的時間才能得到一個有效的檢測方法——在所有站點上都講述了同樣的故事。但我很高興地說我們做到了。我們已經過了那座橋。我們 - 我們在那裡取得了重大突破，我們現在正在努力驗證所有內容並將其放入一個包中。

Okay. And then on the protocol amendment, I'm sorry if I shouldn't be calling it an amendment for PREVENT-19 study, could you just verify the final event rate is still -- I think 144 cases, I guess, will be -- was what we had in the initial protocol? And then my more important question is, as you know, the label for some of these EUA approved vaccines will start to look more specific to a booster going into the fall. So are you able to comment what could be gleaned out of PREVENT-19, if anything, around your booster strategy if at all?

好的。然後關於協議修正案，很抱歉，如果我不應該將其稱為 PREVENT-19 研究的修正案，您能否驗證最終事件發生率仍然 - 我想 144 例病例，我猜，將是 - - 是我們在初始協議中的內容嗎？然後我更重要的問題是，如你所知，這些 EUA 批准的疫苗的標籤將開始看起來更具體到秋季的助推器。那麼，您能否評論一下從 PREVENT-19 中可以收集到的內容，如果有的話，圍繞您的助推器策略（如果有的話）？

Okay. Let me take that in 2 bits. First, as far as the number of cases, the previous version of the protocol called for an events-driven analysis. We're not there anymore. And we weren't there because, like I explained, we had to adjust the study to maintenance its integrity. So now it's a time-based analysis. It's going to be done on events that were collected prior to crossover. And that's going to be the total number of events we have in our analysis, and that will address our efficacy in that label.

好的。讓我把它分成2位。首先，就案例數量而言，之前版本的協議要求進行事件驅動分析。我們已經不在了。而且我們不在那裡，因為就像我解釋的那樣，我們必須調整研究以保持其完整性。所以現在是基於時間的分析。它將在交叉之前收集的事件上完成。這將是我們分析中的事件總數，這將解決我們在該標籤中的功效。

As far as the other question about boosting, nothing from PREVENT-19 will speak directly to boosting. The data we have on boosting is coming from our Phase II study where we've just completed a 6-month boost of people who are initially vaccinated, both with 1 and 2 doses. Additionally, it will come from the South Africa study where people who receive 2 doses are getting a single boost dose in that context. So those are the -- that's the main data we're going to have to talk about boosting in addition to all the really compelling preclinical data that Greg shared with you previously.

至於關於提升的另一個問題，PREVENT-19 中的任何內容都不會直接涉及提升。我們掌握的加強數據來自我們的 II 期研究，在該研究中，我們剛剛完成了對最初接種 1 劑和 2 劑疫苗的人進行為期 6 個月的加強。此外，它將來自南非的研究，在該研究中，接受 2 劑的人在這種情況下將獲得單次加強劑量。因此，除了 Greg 之前與您分享的所有真正令人信服的臨床前數據之外，這些就是我們將不得不談論的主要數據。

I guess a natural follow-up to that is, can that be part of your regulatory submission? The U.K. COMCOR data, the South Africa data, those elements, do they make sense to be part of your regulatory package?

我想一個自然的後續行動是，這可以成為您監管提交的一部分嗎？英國的 COMCOR 數據、南非的數據，這些元素，作為您的監管包的一部分是否有意義？

I think in the initial filing, our main intent is to get primary licensure with the vaccine we have in hand. And a booster trial's use is going to be considered as that data matures and is available. It's my thinking we're going to be filing in advance of having that data mature. So it will come on as a variation or as an imminent to that file.

我認為在最初的申請中，我們的主要目的是獲得我們手頭的疫苗的主要許可。隨著數據的成熟和可用，將考慮使用助推器試驗。我認為我們將在數據成熟之前提交文件。因此，它將作為該文件的變體或迫在眉睫。

Okay. Great. And then final question. On the -- so Stan, you gave color on the monthly run rate getting to 150 million in fourth quarter. Any commentary you can -- I know you used to talk about the annual run rate also? And if you're still guiding to that -- getting to that 2 billion doses mark. And I understand that includes contribution from Serum for about 1 billion, which you seem to be picking up some slack near-term for Serum. So any color on when you can get to that 2 billion doses a year run rate, just factoring in Novavax and your partners' capacity?

好的。偉大的。然後是最後一個問題。關於 - 所以斯坦，你對第四季度的月度運行率達到 1.5 億給出了顏色。你可以發表任何評論——我知道你曾經也談到過年運行率？如果您仍在指導這一點 - 達到 20 億劑劑量。我知道這包括來自 Serum 的大約 10 億美元的貢獻，你似乎在短期內為 Serum 收拾一些閒置。因此，僅考慮 Novavax 和您的合作夥伴的能力，您何時可以達到每年 20 億劑的運行速度？

Yes. I think we will be there by the end of this year and expect to be there throughout the entire 2022.

是的。我認為我們將在今年年底前到達那裡，並預計將在整個 2022 年到達那裡。

The next question comes from Vernon Bernardino with H.C. Wainwright.

下一個問題來自 Vernon Bernardino 和 H.C.溫賴特。

Congrats on the tremendous progress. One question I had is, given the U.S. currently appears to be a flush of vaccine doses. Once you have authorization to provide the 110 million doses promised to the U.S. government, do you anticipate the government to distribute those doses in the U.S. or outside the U.S.? Or is this a buy agreement one that allows you to perhaps change it to one with potential stockpiling like a place marker for a future COVID-19 vaccine against an emerging variant?

祝賀取得了巨大的進步。我的一個問題是，鑑於美國目前似乎正在大量接種疫苗。一旦您獲得授權向美國政府提供承諾的 1.1 億劑疫苗，您是否預計政府會在美國或美國境外分發這些劑量？或者這是一份購買協議，允許您將其更改為具有潛在庫存的協議，例如未來 COVID-19 疫苗針對新興變種的位置標記？

Yes. I think all of the above. I don't think we know -- I don't think anybody has determined what the fate of those 110 million doses are. And that's a discussion that we will have.

是的。我認為以上所有。我認為我們不知道——我認為沒有人確定這 1.1 億劑疫苗的命運。這是我們將要進行的討論。

Okay. And then given the promising results with your RSV vaccine, ResVax, although the data are from a small sample, even one looks like promising data in women who got vaccinated while pregnant, do you anticipate conducting a maternal unitization study with 2373?

好的。然後考慮到您的 RSV 疫苗 ResVax 的有希望的結果，雖然數據來自一個小樣本，但即使是在懷孕期間接種疫苗的女性中看起來也有希望的數據，您是否預計與 2373 進行母體聯合研究？

Right now, our main focus is -- in the pregnant population is to really do what some of the other sponsors have done. We're planning a registry at the far end to capture those cases and assure safety. We should have a relatively sizable population of pregnant women in our studies right now and we're following them very carefully to build that safety database out as well.

目前，我們的主要關注點是——在懷孕人群中真正做其他一些贊助商所做的事情。我們計劃在遠端建立一個登記處，以捕獲這些案例並確保安全。我們現在應該在我們的研究中擁有相對可觀的孕婦群體，並且我們正在非常仔細地跟踪他們以建立該安全數據庫。

Okay. And then last question and I'll go back to the queue. As you probably know, Moderna's vaccine had a single-shot vaccine efficacy of 43%. Regarding the conduct of PREVENT study, have you had enough subjects not coming back for the second dose of 2373? I assume you have. I asked because data from the Phase I/II showed that while antibody levels at day 189 has fallen below the ranges observed in combos and sera from recovered COVID-19 patients, the IVG levels from a single 2373 dose of 25 micrograms plus Matrix-M might not have been enough to confer protection. Therefore, if you advance the combination of the flu plus 2373 to single shot -- and I saw in the paper that what was used as a primary regimen -- you could have a very differentiated vaccine available when it's ready for commercialization, especially if you met the threshold of 50% vaccine efficacy against severe diseases with a single shot.

好的。然後是最後一個問題，我會回到隊列中。您可能知道，Moderna 的疫苗單次疫苗效力為 43%。關於 PREVENT 研究的實施，您是否有足夠多的受試者不回來接受第二劑 2373？我假設你有。我之所以問，是因為 I/II 期的數據顯示，雖然第 189 天的抗體水平已低於從 COVID-19 康復患者的組合和血清中觀察到的範圍，但單次 2373 劑 25 微克加 Matrix-M 的 IVG 水平可能不足以提供保護。因此，如果你將流感加 2373 的組合推進到單次注射——我在論文中看到用作主要方案的疫苗——當它準備好商業化時，你可以有一種非常差異化的疫苗，特別是如果你一次注射就達到了針對嚴重疾病的 50% 疫苗效力的門檻。

Yes. I think those are all good observations. I mean, we'll see. We're going to do a trial in fall combination vaccine and that's one reason we'll learn about. But I think you summarized some of the findings quite well.

是的。我認為這些都是很好的觀察。我的意思是，我們會看到的。我們將在秋季聯合疫苗中進行試驗，這是我們將了解的原因之一。但我認為你很好地總結了一些發現。

And so if I may, just I think, lost to the number. You said that the U.K. drops of 60%?

因此，如果我可以，只是我想，輸給了這個數字。你說英國下降了60%？

And that was data from the U.S. Phase II study, although there was a similar proportion in the U.K. Those people didn't drop out of the study, they just saw the commercial-used vaccine. So they're still being followed.

那是來自美國 II 期研究的數據，雖然在英國也有類似的比例。這些人並沒有退出研究，他們只是看到了商業使用的疫苗。所以他們仍然被跟踪。

This concludes our question-and-answer session. I would like to turn the conference back over to Stanley Erck for any closing remarks.

我們的問答環節到此結束。我想把會議轉回給 Stanley Erck 做任何結束語。

Well, thanks, everybody. As we -- every quarter gets more data pointing to a successful vaccine, we're getting close to the end, and -- which is really the beginning for us and that's what we're all racing to do. I think we've eliminated all of the serious hurdles to getting -- risk hurdles to getting to where we need to be to get an improved vaccine. And so we're excited about that and we look forward to shipping our first product. Thank you.

嗯，謝謝大家。隨著我們——每個季度都有更多數據表明疫苗成功，我們正接近尾聲，而且——這對我們來說真的是一個開始，這就是我們都在努力做的事情。我認為我們已經消除了獲得改進疫苗所需的所有嚴重障礙——到達我們需要到達的地方的風險障礙。所以我們對此感到興奮，我們期待著推出我們的第一個產品。謝謝你。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。