Novavax Inc (NVAX) 2022 Q3 法說會逐字稿

Good afternoon, and welcome to the Novavax Third Quarter 2022 Financial Results and Operational Highlights. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Silvia Taylor, Executive Vice President, Chief Communications Officer. Please go ahead.

下午好，歡迎收看 Novavax 2022 年第三季度財務業績和運營亮點。 （操作員說明）請注意，正在記錄此事件。我現在想將會議轉交給執行副總裁兼首席傳播官 Silvia Taylor。請繼續。

Good afternoon, and thank you all for joining us today to discuss our third quarter 2022 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later today.

下午好，感謝大家今天加入我們，討論我們 2022 年第三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 上獲取，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。

Before we begin with prepared remarks, I need to remind you that this presentation includes forward-looking statements, including information relating to the future of Novavax, its key strategic priorities, plans and prospects for 2022 and financial guidance, including total revenue; the ongoing development of our vaccine candidates, including anticipated timing of trials and results; the scope, timing and outcome of future regulatory filings and actions; the efficacy, safety and intended utilization of our vaccine candidates, including against COVID-19 variants; the global market opportunities for our vaccine candidates; our manufacturing capacity; and the future availability of our vaccine candidates and key upcoming milestones.

在我們開始準備好的評論之前，我需要提醒您，本演示文稿包含前瞻性陳述，包括與 Novavax 的未來、其關鍵戰略重點、2022 年計劃和前景以及財務指導（包括總收入）相關的信息；我們候選疫苗的持續開發，包括預期的試驗時間和結果；未來監管文件和行動的範圍、時間安排和結果；我們候選疫苗的功效、安全性和預期用途，包括針對 COVID-19 變體的疫苗；我們候選疫苗的全球市場機會；我們的製造能力；以及我們候選疫苗的未來可用性和即將到來的關鍵里程碑。

Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding these factors appears under the heading Cautionary Note regarding forward-looking statements in the slide deck we issued this afternoon and under the heading Risk Factors in our most recent Form 10-K and our third quarter Form 10-Q filed with the Securities and Exchange Commission and available at sec.gov and on our website at novavax.com as well as subsequent filings with the SEC.

本演示文稿中包含的每項前瞻性陳述都存在風險和不確定性，這些風險和不確定性可能導致實際結果與此類陳述中預測的結果存在重大差異。有關這些因素的更多信息出現在我們今天下午發布的幻燈片中關於前瞻性陳述的警告性說明標題下，以及我們最近向證券交易所提交的 10-K 表格和第三季度 10-Q 表格中的風險因素標題下和交易委員會，可在 sec.gov 和我們的網站 novavax.com 以及隨後向美國證券交易委員會提交的文件中獲取。

The forward-looking statements in this presentation speak only as of the original date of this presentation, and we undertake no obligation to update or revise any of these statements. During this call, in order to provide greater transparency regarding our operating performance, we refer to certain non-GAAP financial measures that involve adjustments to GAAP results. Any non-GAAP financial measures presented should not be considered to be an alternative to financial measures required by GAAP, should not be considered measures of liquidity and are unlikely to be comparable to non-GAAP financial measures provided by other companies.

本演示文稿中的前瞻性陳述僅在本演示文稿的原始日期發表，我們不承擔更新或修改任何這些陳述的義務。在本次電話會議中，為了提高我們經營業績的透明度，我們參考了某些涉及對 GAAP 結果進行調整的非 GAAP 財務指標。所提供的任何非 GAAP 財務措施不應被視為 GAAP 要求的財務措施的替代方案，不應被視為流動性措施，並且不太可能與其他公司提供的非 GAAP 財務措施相比較。

Any non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measure within the Investors section of our website at novavax.com. Now please turn to Slide 4. Joining me today is Stan Erck, President and CEO, who will provide an update on our recent progress in our upcoming strategic priorities. Additionally, Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical development across our pipeline; and John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on our commercial progress and our outlook for 2023.

本次電話會議中引用的任何非 GAAP 財務指標都與我們網站 novavax.com 投資者部分中最直接可比的 GAAP 財務指標相一致。現在請轉到幻燈片 4。今天和我一起的是總裁兼首席執行官 Stan Erck，他將介紹我們在即將到來的戰略重點方面的最新進展。此外，首席醫療官 Filip Dubovsky 博士將討論我們整個產品線的臨床開發；首席商務官兼首席商務官 John Trizzino 將提供有關我們商業進展和 2023 年展望的最新信息。

Finally, Jim Kelly, our Chief Financial Officer and Treasurer, will provide an update of our financial results. Dr. Greg Glenn, President of Research and Development, will also be available for the Q&A section at the end of today's call. I'd now like to hand the call over to Stan. Please turn to Slide 5.

最後，我們的首席財務官兼財務主管 Jim Kelly 將提供我們最新的財務業績。研發總裁 Greg Glenn 博士也將出席今天電話會議結束時的問答環節。我現在想把電話轉給 Stan。請轉到幻燈片 5。

Thanks, Silvia. Good afternoon, and thanks for joining our third quarter earnings call. In addition to the financial report that Jim Kelly will give, Filip will provide our update on important clinical data that we are accumulating which continue to highlight the advantages offered by our adjuvanted protein-based vaccine. And following that, John will discuss our commercialization efforts.

謝謝，西爾維亞。下午好，感謝您加入我們的第三季度財報電話會議。除了吉姆·凱利 (Jim Kelly) 將提供的財務報告外，菲利普 (Filip) 還將提供我們正在積累的重要臨床數據的最新信息，這些數據將繼續強調我們的佐劑蛋白疫苗所提供的優勢。之後，約翰將討論我們的商業化工作。

First, let me start with the financials. Jim will provide you more details, but the highlights include revenue for the quarter was $735 million. This met our target for the quarter and bring us to $1.6 billion in revenue for the first 9 months of the year. During the last quarter, we continued to gather data that supports the differentiation of our vaccine. We believe these differences are important and are a predictable consequence of our vaccine technology.

首先，讓我從財務開始。 Jim 將為您提供更多詳細信息，但亮點包括本季度的收入為 7.35 億美元。這達到了我們本季度的目標，並使我們今年前 9 個月的收入達到 16 億美元。在上個季度，我們繼續收集支持我們疫苗差異化的數據。我們認為這些差異很重要，並且是我們疫苗技術的可預測結果。

When our nanoparticle antigen is formulated with Matrix-M, it generates a very broad and long-lived immune response, which we believe has advantages in the face of the continued emergence of new variants. We believe that these differences will allow us to deploy a vaccine that may not require serial updating and may not require Novavax's vaccine has been granted regulatory authorizations globally.

當我們的納米顆粒抗原與 Matrix-M 一起配製時，它會產生非常廣泛和持久的免疫反應，我們相信它在面對不斷出現的新變種時具有優勢。我們相信，這些差異將使我們能夠部署一種可能不需要連續更新並且可能不需要 Novavax 的疫苗在全球範圍內獲得監管授權的疫苗。

In the third quarter, we received Emergency Use Authorization from the United States, representing the last major market in which we have obtained authorization for use. Throughout the year, we have been developing data with our many clinical trials across the globe that support the advantages of our vaccine. And together, we believe these advantages will be the basis for the continued long-term expansion of our products in markets throughout the world.

第三季度，我們獲得了美國的緊急使用授權，這是我們獲得使用授權的最後一個主要市場。全年，我們一直在通過我們在全球範圍內的許多臨床試驗來開發數據，以支持我們疫苗的優勢。我們相信，這些優勢將共同成為我們產品在全球市場持續長期擴張的基礎。

We now have data supporting Nuvaxovid's durable immune response that achieves levels associated with protection in our Phase III trials. With the ever-mutating COVID virus, we want a vaccine that can stimulate an antibody response across any variant that arises. And while we can't predict the future, we can show that our vaccine has a breadth of response that covers all of the variants that we've measured to date, including alpha, beta, delta and BA.1 through 5.

我們現在有數據支持 Nuvaxovid 的持久免疫反應，在我們的 III 期試驗中達到與保護相關的水平。對於不斷變異的 COVID 病毒，我們需要一種疫苗來刺激對出現的任何變體的抗體反應。雖然我們無法預測未來，但我們可以證明我們的疫苗具有廣泛的反應範圍，涵蓋我們迄今為止測量的所有變體，包括 alpha、beta、delta 和 BA.1 到 5。

This is important for obvious reasons. But it should be pointed out that we don't have any data which suggests that it's a good decision to switch to a BA.5 vaccine given that our current vaccine stimulates levels a BA.5 antibody that should be protective. Our data also shows -- show that we have an 82% prevention of infection over an extended period and plus our data continues to provide confidence in the use of our vaccine and its safety, its favorable safety and tolerability profile.

出於顯而易見的原因，這很重要。但應該指出的是，我們沒有任何數據表明改用 BA.5 疫苗是一個明智的決定，因為我們目前的疫苗會刺激 BA.5 抗體水平，而該水平應該具有保護作用。我們的數據還顯示——表明我們在較長時間內可以預防 82% 的感染，而且我們的數據繼續為我們疫苗的使用及其安全性、良好的安全性和耐受性提供信心。

Our mission must be to remind and educate the regulatory and policy bodies that as a protein-based adjuvanted vaccine, our vaccine is different from what's on the market. As long as we continue to demonstrate that our current vaccine stimulates a relevant immune response against circulating barriers, we believe our current vaccine will be a good choice for ongoing vaccination campaigns.

我們的使命必須是提醒和教育監管和政策機構，作為一種基於蛋白質的佐劑疫苗，我們的疫苗與市場上的疫苗不同。只要我們繼續證明我們目前的疫苗可以刺激針對循環障礙的相關免疫反應，我們相信我們目前的疫苗將是正在進行的疫苗接種活動的不錯選擇。

And importantly, it has the added advantage that when you continue to boost with the same vaccine, you continue to see maturation of these responses with the expectation that you'll see more effective and longer-lasting responses. When we see data that suggests the need to update our vaccine with a new strain, we will. We will do so with either a monovalent or bivalent vaccine based on data that we then have and relevant policy recommendations at the time.

重要的是，它還有一個額外的優勢，即當您繼續使用相同的疫苗進行加強時，您會繼續看到這些反應的成熟，並期望您會看到更有效和更持久的反應。當我們看到數據表明需要用新毒株更新我們的疫苗時，我們就會這樣做。我們將根據當時掌握的數據和相關政策建議，使用單價或雙價疫苗。

There may be some public health agencies that prefer either a strain change or bivalent vaccine and our plan is to develop in parallel, a variant containing monovalent and bivalent vaccine. Switching topics. We have mentioned in the past that we have been collaborating with the Serum Institute and Oxford University on a new malaria vaccine that includes our Matrix-M adjuvant. I'm very pleased that Adrian Hill of Oxford University presented a very high-level summary of Phase III efficacy data at a late-breaking session of the Tropical Disease and Malaria Conference in Seattle last week.

可能有一些公共衛生機構更喜歡變株疫苗或二價疫苗，我們的計劃是同時開發一種包含單價和二價疫苗的變體。切換話題。我們過去曾提到，我們一直在與血清研究所和牛津大學合作開發一種新的瘧疾疫苗，其中包括我們的 Matrix-M 佐劑。我很高興牛津大學的 Adrian Hill 上週在西雅圖舉行的熱帶病和瘧疾會議的最新會議上對 III 期療效數據進行了非常高水平的總結。

More detailed safety and efficacy data will be available when approved for publication later this year. Going forward, we believe that we're in a very good position. We have a global manufacturing capacity to support our planned sales of Nuvaxovid. This capacity will also support our pipeline vaccine candidates for flu, for combination flu COVID and for malaria. And we now have a global marketing and regulatory presence to support our goals for 2023 and beyond.

更詳細的安全性和有效性數據將在今年晚些時候獲得批准發布。展望未來，我們相信我們處於非常有利的位置。我們擁有全球製造能力來支持我們計劃的 Nuvaxovid 銷售。這種能力還將支持我們針對流感、聯合流感 COVID 和瘧疾的管道候選疫苗。我們現在擁有全球營銷和監管機構，以支持我們 2023 年及以後的目標。

I'll now turn the call -- the presentation over to our Chief Medical Officer, Filip Dubovsky, who will be followed by John Trizzino, our Chief Commercial Officer and our Chief Financial Officer, Jim Kelly. We will end with a session of Q&A.

我現在將電話轉給我們的首席醫療官 Filip Dubovsky，然後是我們的首席商務官 John Trizzino 和我們的首席財務官 Jim Kelly。我們將以問答環節結束。

Thanks, Stan. Since the last call, we have developed a significant amount of new clinical data. Today, I'm going to review data from Study 307, which is our lot-to-lot consistency study that includes heterologous boosting on top of 2 and 3 doses of mRNA. Then, I'll describe preliminary findings from study 311, our strain change study that evaluated boosted responses to a prototype vaccine, Omicron BA.1 vaccine and bivalent vaccine when given on top of 3 doses of mRNA vaccine.

謝謝，斯坦。自上次通話以來，我們已經開發了大量新的臨床數據。今天，我將回顧 Study 307 的數據，這是我們的批次間一致性研究，包括在 2 劑和 3 劑 mRNA 之上進行異源加強。然後，我將描述研究 311 的初步發現，我們的菌株變化研究評估了在 3 劑 mRNA 疫苗之上給予原型疫苗、Omicron BA.1 疫苗和二價疫苗的增強反應。

But first, I want to review some findings we have recently disclosed. Please advance to Slide 7. From our U.K. study, we recently published that our vaccine had 82% efficacy for preventing all infections over 6 months observation period. This was despite the majority of cases being caused by the alpha variant. Protection from infection is important because if you don't get infected, you can't transmit virus, you can't get sequelae for COVID, and you can't get long COVID and you can't be the source of new variants.

但首先，我想回顧一下我們最近披露的一些調查結果。請轉到幻燈片 7。根據我們在英國的研究，我們最近公佈了我們的疫苗在 6 個月的觀察期內預防所有感染的效率為 82%。儘管大多數病例是由 alpha 變體引起的。防止感染很重要，因為如果你沒有被感染，你就不會傳播病毒，你就不會得到 COVID 的後遺症，你就不會得到長期的 COVID，你就不會成為新變種的來源。

In our adult U.S. Mexico Phase III study, we achieved a formal regulatory endpoint supporting boosting in the U.S. population, and we demonstrated a durable immune response as well as a broad immune response that includes cross-reactive antibody levels directed against drifted Omicron variants that were consistent with levels associated with protection in our Phase III studies.

在我們的成人美國墨西哥 III 期研究中，我們實現了支持美國人口增加的正式監管終點，我們展示了持久的免疫反應以及廣泛的免疫反應，包括針對漂移的 Omicron 變體的交叉反應抗體水平與我們 III 期研究中與保護相關的水平一致。

In our adolescents Phase III study, we made the regulatory endpoint for boosting in 12- to 17-year-olds and show the hemologic responses to Omicron variants were comparable to those associated with protection.

在我們的青少年 III 期研究中，我們制定了 12 至 17 歲青少年加強免疫的監管終點，並顯示對 Omicron 變體的血液學反應與與保護相關的反應相當。

Okay. Let's go to Slide 8 and talk about Study 307, which is our lot-to-lot consistency study. For this study, I'll discuss data supporting the achievement of our lot-to-lot endpoint and the magnitude and breadth of the heterologous boosting response.

好的。讓我們轉到幻燈片 8 並討論研究 307，這是我們的批次間一致性研究。對於這項研究，我將討論支持我們實現批次間終點的數據以及異源增強反應的幅度和廣度。

This is still preliminary data, and additional immunologic assessment is ongoing. So let's move to Slide 9, please. Study 307 enrolled 911 adults in the U.S. who had no history of recent COVID infection and who had received 2 or 3 doses of an approved COVID vaccine, with the last dose being at least 6 months prior to enrollment. As you can see on this slide, most of our subjects received 2 or 3 doses of either Moderna or Pfizer.

這仍然是初步數據，正在進行額外的免疫學評估。請轉到幻燈片 9。 Study 307 在美國招募了 911 名成年人，他們沒有近期 COVID 感染史，並且接受過 2 劑或 3 劑經批准的 COVID 疫苗，最後一劑在入組前至少 6 個月。正如您在這張幻燈片上看到的，我們的大多數受試者都接受了 2 或 3 劑 Moderna 或輝瑞疫苗。

A few received 1 or 2 doses of J&J and a very small number had received 2 doses of Novavax. After enrollment, all subjects were boosted with 1 of 3 different lots of Novavax vaccine and the serum was collected at day 28 for immunologic assessment.

一些人接受了 1 劑或 2 劑強生，極少數人接受了 2 劑 Novavax。登記後，所有受試者都用 3 種不同批次的 Novavax 疫苗中的一種進行加強，並在第 28 天收集血清用於免疫學評估。

Let's move to Slide 10. Demographics show the 3 lot groups were well balanced. The racial makeup was broadly representative of the general U.S. population and the median interval prior to the Novavax boost was approximately 9 months.

讓我們轉到幻燈片 10。人口統計數據顯示 3 個批次組非常平衡。種族構成廣泛代表了美國總人口，Novavax 加強前的中位間隔時間約為 9 個月。

Let's go to Slide 11 and look at the primary endpoint. As you can see here, the primary endpoint of non-inferior immunogenicity was achieved, as measured by anti-S IgG titers at day 28. This was the regulatory endpoint confirming consistency of our manufacturing process. You can please note the extremely tight confidence intervals here. But let's look at the immune responses following heterologous and homologous boosting on Slide 12, please. Because most of the subjects in this trial received the Novavax vaccine as a heterologous booster, we had the opportunity to evaluate the magnitude and breadth of immunogenicity in different subsets.

讓我們轉到幻燈片 11 並查看主要終點。正如您在此處看到的，在第 28 天通過抗 S IgG 滴度測量，實現了非劣效免疫原性的主要終點。這是確認我們製造過程一致性的監管終點。您可以在此處注意極其嚴格的置信區間。但是請讓我們看看幻燈片 12 上異源和同源增強後的免疫反應。由於該試驗中的大多數受試者都接受了 Novavax 疫苗作為異源加強劑，因此我們有機會評估不同亞群的免疫原性的程度和廣度。

Shown on the far left are IgG responses in a small group of 7 subjects who received 2 doses of Novavax's priming series followed by a single Novavax boost. We're also showing responses for those who received 2 prior does of Moderna, 2 prior doses of Pfizer and 1 dose of J&J. A super imposed a closer protection threshold derived by the U.S. government based on our U.S. Phase III trial and the actual Phase III levels we obtained in our 2 Phase III studies.

最左邊顯示的是一組 7 名受試者的 IgG 反應，這些受試者接受了 2 劑 Novavax 的啟動系列，然後接受了單次 Novavax 加強。我們還顯示了之前接受過 2 劑 Moderna、2 劑 Pfizer 和 1 劑 J&J 的患者的反應。美國政府根據我們的美國 III 期試驗和我們在 2 項 III 期研究中獲得的實際 III 期水平得出了更嚴格的保護閾值。

The post-booster levels we saw in this trial matched or exceeded the levels achieved in the Phase III efficacy study. Consistent with what we've seen previously, we observed the highest antibody titers for the homologous Novavax boosting subset.

我們在該試驗中看到的加強後水平與 III 期療效研究中達到或超過了水平。與我們之前看到的一致，我們觀察到同源 Novavax 加強亞群的最高抗體滴度。

Okay, let's go to Slide 13 and look at heterologous boosting on top of 3 doses of mRNA. This is a similar set-up to the previous slide, but for the group's received 3 prior doses of Moderna or Pfizer or 2 prior doses of J&J. So a full primary course plus 1 prior boost.

好的，讓我們轉到幻燈片 13 並查看在 3 劑 mRNA 之上的異源加強。這是與上一張幻燈片類似的設置，但該組之前接受了 3 劑 Moderna 或輝瑞，或者之前接受了 2 劑強生。因此，完整的初級課程加上 1 個先前的提升。

In each of these subsets, the antibody levels exceeded the Phase III levels. And for the mRNA recipients levels were approximately 20% to 30% higher than we saw in the previous slide with priming was just 2 doses of mRNA. The group with 2 doses of J&J had broad conference intervals because of the small sample size.

在這些子集中的每一個中，抗體水平都超過了 III 期水平。對於 mRNA 受體，水平比我們在上一張幻燈片中看到的高大約 20% 到 30%，而啟動僅為 2 劑 mRNA。由於樣本量小，服用 2 劑 J&J 的組的會議間隔時間很長。

Now let's look at Slide 14 to look at the breadth of immune response. Here, we evaluated IgG responses to prototype and to Omicron subvariants BA.1 and 5. we are displaying the 2 doses of Novavax boosted once with Novavax as a solid bar on the far left-hand side of each triplet. And that's compared to 3 doses of Moderna or 3 doses of Pfizer boosted once with Novavax.

現在讓我們看一下幻燈片 14，了解免疫反應的廣度。在這裡，我們評估了 IgG 對原型和 Omicron 亞變體 BA.1 和 5 的反應。我們展示了 2 劑 Novavax 增強一次，Novavax 作為每個三聯體最左側的實心條。這與使用 Novavax 增強一次的 3 劑 Moderna 或 3 劑輝瑞相比。

In all cases, IgG titers achieved levels predicted to be course or protection was approximately 88% to 95%. As before, the highest antibody titers against both prototype and variants were in homologous Novavax-boosted subjects.

在所有情況下，IgG 滴度達到預測的病程或保護水平約為 88% 至 95%。和以前一樣，針對原型和變體的最高抗體滴度出現在同源的 Novavax 增強受試者中。

In summary, we believe the 307 findings are important both because they confirm consistency of manufacturing, which is critical for vaccine life insured in the U.S. and because they showed robust immune responses to prototype and variants after homologous and heterologous boosting with post-boosting antibody levels approximating those levels associated with protection in our Phase III studies.

總而言之，我們認為 307 的發現很重要，因為它們證實了製造的一致性，這對美國投保的疫苗壽命至關重要，而且因為它們在同源和異源增強後顯示出對原型和變體的強大免疫反應以及增強後抗體水平接近我們 III 期研究中與保護相關的水平。

So let's move to Slide 15 and talk about the next study. Now I'll review the top line data from study 311. The study was designed as a strain-change study and evaluated the performance of our prototype vaccine and Omicron BA.1 vaccine and a bivalent format vaccine when given after 2 and 3 doses of mRNA. So let's go to Slide 16, the design. The study was conducted in Australia in adults 18 to 64 years of age. The participants received 2 or 3 doses of mRNA and were boosted with either our prototype vaccine, the BA.1 vaccine or the bivalent vaccine.

那麼讓我們轉到幻燈片 15 並討論下一項研究。現在我將回顧研究 311 的主要數據。該研究被設計為菌株變化研究，並評估了我們的原型疫苗和 Omicron BA.1 疫苗以及在接種 2 劑和 3 劑疫苗後給予的雙價形式疫苗的性能。 mRNA。那麼讓我們轉到幻燈片 16，設計。該研究在澳大利亞 18 至 64 歲的成年人中進行。參與者接受了 2 或 3 劑 mRNA，並使用我們的原型疫苗、BA.1 疫苗或二價疫苗進行加強。

Today, I will only talk about participants who received 3 prior doses of mRNA and who are boosted at least 90 days after their last dose. So let's look at demographics on Slide 17. The study groups are well balanced with facial group's representative of the overall Australian population, the participants received their boost, the median of 180 days after their last mRNA dose.

今天，我將只討論之前接受過 3 劑 mRNA 並且在最後一劑後至少 90 天加強免疫的參與者。那麼讓我們看看幻燈片 17 上的人口統計數據。研究組與代表澳大利亞總人口的面部組非常平衡，參與者得到了他們的提升，即最後一次 mRNA 給藥後 180 天的中位數。

You can see that Australia did a better job of controlling infection as a relatively large proportion of this group did not have evidence of prior COVID infection.

你可以看到澳大利亞在控制感染方面做得更好，因為這個群體中有相當大一部分人沒有之前感染 COVID 的證據。

So let's look at the endpoints on Slide 18. The primary endpoint for the strain-change portion was prespecified to be in a 3-dose group and participants who had no prior COVID infections. We compared the day 14 neutralizing responses against BA.1 in the 3 treatment groups.

因此，讓我們看一下幻燈片 18 上的終點。應變變化部分的主要終點被預先指定為 3 劑組和之前沒有感染過 COVID 的參與者。我們比較了 3 個治療組中針對 BA.1 的第 14 天中和反應。

In the first column, we compare BA.1 neutralization responses after being boosted with BA.1 vaccine to the BA.1 responses after being boosted with prototype. This was a strain-change endpoint. And because the BA.1 vaccine responses against BA.1 were higher than those induced by the prototype vaccine, the study achieved a statistical endpoint, allowing for a strain-change, if eventually needed.

在第一列中，我們將使用 BA.1 疫苗加強後的 BA.1 中和反應與使用原型加強後的 BA.1 反應進行比較。這是一個應變變化終點。由於 BA.1 疫苗對 BA.1 的反應高於原型疫苗誘導的反應，因此該研究達到了統計終點，允許在最終需要時進行菌株變化。

Let's get a click. The second column compares a bivalent vaccine to prototype. The responses were similar with the conference intervals overlapping one. And the final column compares the bivalent vaccine to the BA.1 vaccine and the responses were lower for the bivalent vaccine. Let's have a click. So as far as the BA.1 responses go, the data does not support a measurable benefit for the bivalent vaccine.

讓我們點擊一下。第二列將二價疫苗與原型進行比較。響應與會議間隔重疊一個相似。最後一欄比較了二價疫苗和 BA.1 疫苗，二價疫苗的反應較低。讓我們點擊一下。因此，就 BA.1 反應而言，數據不支持二價疫苗具有可衡量的益處。

Okay. Let's look at some comparative data on Slide 19. Here, we're looking at IgG responses against BA.1 and all the participants who received 3 prior doses of mRNA vaccine. This group most closely resembles the general population. Here, the responses were similar between all 3 vaccines. Although when boosted with our prototype, it was numerically higher by about 15%.

好的。讓我們看一下幻燈片 19 上的一些比較數據。在這裡，我們正在查看針對 BA.1 的 IgG 反應以及所有先前接受過 3 劑 mRNA 疫苗的參與者。這個群體與一般人群最相似。在這裡，所有 3 種疫苗的反應相似。雖然當使用我們的原型進行提升時，它在數值上高出約 15%。

Please advance to Slide 20. Here, we're looking at IgG responses against prototype strain. Once again, the responses were statistically comparable with up to a 20% numerical benefit for boosting with the prototype vaccine. Of course, neither prototype nor BA.1 are in circulation currently.

請轉到幻燈片 20。在這裡，我們正在研究針對原型菌株的 IgG 反應。再一次，這些反應在統計學上具有可比性，使用原型疫苗加強免疫可獲得高達 20% 的數值收益。當然，目前原型和 BA.1 都沒有流通。

So let's look at 4 different strains, Slide 21, please. Displayed here is a neutralization response against BA.5 measured in functional pseudoneutralization assay. BA.5 is an omicron subvariant that was not in any other vaccines, but it's related to the BA.1, so we won't expect a superior response with BA.1 vaccine. However, there was no benefit observed for either BA.1 vaccine nor the bivalent vaccine compared to the prototype vaccine.

那麼讓我們看一下 4 種不同的菌株，幻燈片 21，請。這裡顯示的是在功能假中和測定中測量的針對 BA.5 的中和反應。 BA.5 是一種 omicron 亞變體，不存在於任何其他疫苗中，但它與 BA.1 相關，因此我們預計 BA.1 疫苗不會產生更好的反應。然而，與原型疫苗相比，BA.1 疫苗和二價疫苗均未觀察到任何益處。

In fact, the prototype vaccine get numerically higher responses. This indicates that boosting with our current vaccine is a viable approach and be considered as a future-proof strategy for emerging variants.

事實上，原型疫苗得到的反應在數值上更高。這表明使用我們當前的疫苗進行加強是一種可行的方法，並被視為針對新興變體的一種面向未來的策略。

Okay, let's look at some echogenicity on Slide 22. When given as a second boost dose for all 3 formulations, they were similarly well tolerated with patterns consistent to what we've seen previously. Here are the most common local reactions are paid in tenderness, the vast majority being none, mild or moderate in severity.

好的，讓我們看看幻燈片 22 上的一些迴聲。當作為所有 3 種製劑的第二次加強劑量給藥時，它們同樣具有良好的耐受性，其模式與我們之前看到的一致。以下是最常見的局部反應，表現為壓痛，絕大多數沒有，嚴重程度為輕度或中度。

Let's go to Slide 23 and look at solicited systemic symptoms and the pattern is also very similar to what we've seen previously with very low rates of Grade 3 events and a negligible fever signal.

讓我們轉到幻燈片 23 並查看徵求的全身症狀，其模式也與我們之前看到的非常相似，即 3 級事件發生率非常低且發燒信號可忽略不計。

Okay. Let's sum this up on Slide 24. So to sum up, we believe our data supports the continued and future use of NVX-2373 as a booster. From our U.S. Mexico Phase III study using our prototype vaccine, we have described a durable immune response and hemologic data indicating that the levels achieved against drifted Omicron variants were consistent with levels associated with protection in our Phase III studies.

好的。讓我們在幻燈片 24 上總結一下。總而言之，我們相信我們的數據支持繼續和未來使用 NVX-2373 作為助推器。從我們使用我們的原型疫苗的美國墨西哥 III 期研究中，我們描述了持久的免疫反應和血液學數據，表明針對漂移的 Omicron 變體達到的水平與我們 III 期研究中保護相關的水平一致。

Today, I showed you data that when we -- are used as a heterologous booster after 2 or 3 doses of authorized vaccine, we achieve broad immune responses against drifted Omicron variants. And the magnitude of these responses are considered to be protective when applying the NIH U.S. government calls of protection thresholds. Finally, our study with Omicron BA.1 vaccine and bivalent vaccine indicated no measurable benefit over our prototype vaccine.

今天，我向您展示了數據，當我們——在 2 或 3 劑授權疫苗後被用作異源助推器時，我們實現了針對漂移的 Omicron 變體的廣泛免疫反應。在應用 NIH 美國政府保護閾值呼籲時，這些反應的強度被認為具有保護作用。最後，我們對 Omicron BA.1 疫苗和二價疫苗的研究表明與我們的原型疫苗相比沒有可衡量的好處。

So when we think about what will be causing illness over the next few months, it will not BA.5, where there's some variant that is yet to emerge. The vaccine that induces high levels of cross-variant responses might be appealing as a way to future-proof ongoing boosting effort. Importantly, the vaccine is currently stocked and can be deployed immediately.

因此，當我們考慮未來幾個月會導致疾病的原因時，它不會是 BA.5，那裡還有一些尚未出現的變體。誘導高水平交叉變異反應的疫苗作為一種面向未來的持續推進努力的方式可能很有吸引力。重要的是，該疫苗目前有庫存，可以立即部署。

Finally, because this is our original vaccine, we have confidence in the preexisting long-lived safety database. This may be a feature that's attractive to individuals who are hesitant to be boosted. Okay. Let me turn it over to John Trizzino.

最後，因為這是我們的原始疫苗，我們對先前存在的長期安全數據庫充滿信心。這可能是一個對那些猶豫要不要提升的人有吸引力的特徵。好的。讓我把它交給 John Trizzino。

Thank you, Filip. Our doses delivered to date also include over 19 million doses by our strategic partners, Serum Institute of India, SK Bioscience and Takeda licensed territories. We remain in ongoing discussions with our customers around the world, including the EU, U.S., Canada, U.K., Australia and others, to ensure optimal supply of doses through the remainder of the year and into 2023.

謝謝你，菲利普。我們迄今為止交付的劑量還包括我們的戰略合作夥伴、印度血清研究所、SK Bioscience 和武田許可區域提供的超過 1900 萬劑。我們將繼續與世界各地的客戶進行討論，包括歐盟、美國、加拿大、英國、澳大利亞和其他國家，以確保在今年剩餘時間和 2023 年之前提供最佳劑量供應。

Notably, in the U.K., we delivered an initial 1 million doses in the third quarter. We are in active discussions with the U.K. Health Services Agency around supply and continue to provide data to JCVI to support policy recommendations for boosting in adolescents and expect to receive MHRA approval for adult booster imminently.

值得注意的是，在英國，我們在第三季度交付了最初的 100 萬劑。我們正在與英國衛生服務局就供應進行積極討論，並繼續向 JCVI 提供數據以支持針對青少年加強注射的政策建議，並預計很快會獲得 MHRA 對成人加強注射劑的批准。

In the EU, we are expanding our presence and strengthening our partnerships for now and well into the future. To support this, we are in the process of finalizing a revised delivery schedule for the remaining 23 million doses committed under our APA. In the U.S., we remain in ongoing discussions around additional supply of our COVID vaccine now available for boosting of adults 18 and over.

在歐盟，我們正在擴大我們的存在並加強我們現在和未來的伙伴關係。為支持這一點，我們正在為根據 APA 承諾的剩餘 2300 萬劑疫苗完成修訂後的交付時間表。在美國，我們仍在繼續討論是否可以為 18 歲及以上的成年人提供額外的 COVID 疫苗供應。

Please turn to Slide 27. We continue to closely monitor the market landscape, and we believe the current global vaccination trends and the upcoming winter respiratory season present an ongoing near-term opportunity to drive uptake of our vaccine. In the U.S., according to recent CDC data, around 39% of adolescents have yet to complete their primary vaccination series.

請轉到幻燈片 27。我們繼續密切關注市場格局，我們相信當前的全球疫苗接種趨勢和即將到來的冬季呼吸季節為推動我們疫苗的普及提供了一個持續的近期機會。在美國，根據疾病預防控制中心最近的數據，大約 39% 的青少年尚未完成他們的初級疫苗接種系列。

Additionally, around 47% of vaccinated adults have yet to receive a first booster dose. Additionally, in the U.K., Germany, France, Italy and Spain, around 48% of adolescents have yet to complete their primary vaccination series and around 20% of vaccinated adults, aged 18 to 59, have yet to receive a booster.

此外，大約 47% 的已接種疫苗的成年人尚未接受第一劑加強劑。此外，在英國、德國、法國、意大利和西班牙，大約 48% 的青少年尚未完成他們的初級疫苗接種系列，大約 20% 的 18 至 59 歲的已接種疫苗的成年人尚未接受加強劑。

With authorization now received for primary vaccination in adolescents in the U.S., EU and U.K. and for a booster dose in adults in the U.S. and EU, our recent label expansion aligns with this market need. Outside of the U.S. and Europe, we see similar dynamics that present additional near-term opportunity to expand the portfolio of vaccine options and appeal to those not yet vaccinated or not yet boosted.

現在已獲得美國、歐盟和英國青少年初級疫苗接種以及美國和歐盟成人加強劑量的授權，我們最近的標籤擴展符合這一市場需求。在美國和歐洲之外，我們看到了類似的動態，這些動態提供了額外的近期機會來擴大疫苗選擇組合併吸引那些尚未接種疫苗或尚未加強疫苗接種的人。

In fact, we have already begun to see encouraging evidence of health care providers and consumers utilizing our vaccine as a booster dose. Based upon available data through October, around 60% of Nuvaxovid doses administered globally have been used as a booster.

事實上，我們已經開始看到令人鼓舞的證據，表明醫療保健提供者和消費者使用我們的疫苗作為加強劑。根據截至 10 月份的可用數據，全球大約 60% 的 Nuvaxovid 劑量被用作加強劑。

Please turn to Slide 28. Our key focus to capture the near-term and long-term market opportunity is to expand our label to include adolescent boosting based upon the compelling data Filip discussed today and in the U.S. to also include additional booster doses in adults.

請轉到幻燈片 28。我們抓住近期和長期市場機會的主要重點是擴大我們的標籤，根據 Filip 今天和美國討論的令人信服的數據包括青少年加強劑量，以包括成人的額外加強劑量.

Alongside this, we will also focus, as always, on gaining supportive policy recommendations. These efforts will build upon our label expansion to date, which includes authorizations for primary vaccination in adults over 40 -- in over 40 countries, authorizations for primary vaccination in adults in the U.S., EU and 11 additional countries, authorizations for boosting in adults in the U.S., EU and 6 additional countries.

除此之外，我們還將一如既往地關注獲得支持性政策建議。這些努力將建立在我們迄今為止的標籤擴展的基礎上，其中包括授權在 40 多個國家對 40 歲以上的成年人進行初級疫苗接種，授權在美國、歐盟和其他 11 個國家對成年人進行初級疫苗接種，授權在成人中加強疫苗接種美國、歐盟和另外 6 個國家。

Please turn to Slide 29. Looking to the long-term COVID-19 market opportunity, we expect to see a transition to a commercial market in the U.S. and other key regions in 2023. With clear evidence that the virus is not going away, we expect an ongoing need for annual seasonal vaccination, resulting in a recurrent COVID-19 booster market. And we believe this opportunity will be larger than the annual influenza market due to COVID-19's greater burden of disease and higher infectivity rate.

請轉到幻燈片 29。展望 COVID-19 的長期市場機遇，我們預計 2023 年美國和其他關鍵地區將向商業市場過渡。有明確證據表明該病毒不會消失，我們預計將持續需要每年進行季節性疫苗接種，從而導致 COVID-19 助推器市場反復出現。我們相信，由於 COVID-19 的疾病負擔更大和傳染率更高，這一機會將大於年度流感市場。

In the U.S., we believe an annual booster market in 2023 and beyond can include around 225 million individuals, which is significantly larger than the annual U.S. flu market in recent years of 170 million to 190 million individuals. In the U.K. and the other key markets in the EU, we believe this could be around 250 million individuals. This potential recurring opportunity includes individuals that have already received their first booster dose as well as individuals that have been fully vaccinated and are eligible to receive a booster.

在美國，我們認為 2023 年及以後的年度助推器市場可包括約 2.25 億人，這大大高於美國近年來每年 1.7 億至 1.9 億人的流感市場。在英國和歐盟的其他主要市場，我們認為這可能約為 2.5 億人。這種潛在的重複機會包括已經接受了第一劑加強劑的個人以及已經完全接種疫苗並有資格接受加強劑的個人。

Importantly, beyond these geographies, we believe that a similar sizable and recurring booster opportunity will also take shape in other key markets, including Asia Pacific.

重要的是，除了這些地區之外，我們相信類似的規模龐大且反復出現的助推器機會也將在其他主要市場形成，包括亞太地區。

Please turn to Slide 30. As we look toward this long-term market, we believe our competitive product profile will differentiate our vaccine among health care providers and drive adoption among consumers.

請轉到幻燈片 30。當我們展望這個長期市場時，我們相信我們具有競爭力的產品組合將使我們的疫苗在醫療保健提供者中脫穎而出，並推動消費者採用。

As Filip discussed today, we continue to build on our existing body of clinical evidence with additional data to demonstrate our vaccines key benefits such as its high efficacy, strong durability of immune responses, protection against infection, favorable safety and reactogenicity profile and importantly, its breadth of immune responses against a broad range of variance.

正如 Filip 今天所討論的那樣，我們將繼續以現有的臨床證據為基礎，提供更多數據來證明我們疫苗的主要優勢，例如其高效、免疫反應的持久性、防止感染、良好的安全性和反應原性，重要的是，它的針對廣泛差異的免疫反應的廣度。

We believe these key benefits, coupled with our vaccines well-established technology platform and favorable transportation and storage profile, create a competitive product offering. Based upon our data generated to date, including initial results announced today for our Omicron variant vaccine program, our commercial strategy is to continue deployment of our prototype vaccine.

我們相信，這些主要優勢，加上我們完善的疫苗技術平台和有利的運輸和儲存條件，將創造出具有競爭力的產品。根據我們迄今為止生成的數據，包括今天公佈的 Omicron 變體疫苗計劃的初步結果，我們的商業戰略是繼續部署我們的原型疫苗。

With that being said, as Filip mentioned, we will continue to generate additional data and be prepared to supply a variant-specific vaccine, if supported by data or requested by our customers.

話雖如此，正如 Filip 提到的那樣，如果數據支持或我們的客戶要求，我們將繼續生成更多數據並準備提供特定變體的疫苗。

Regarding commercial strategy, please turn to Slide 31. With strong foundational elements in place, we are executing our robust commercial strategy. I'd like to highlight a few of our key commercial priorities that we believe will drive success in 2023 and beyond.

關於商業戰略，請轉到幻燈片 31。憑藉強大的基礎要素，我們正在執行穩健的商業戰略。我想強調一些我們認為將在 2023 年及以後取得成功的關鍵商業優先事項。

First, we are expanding our commercial footprint in priority markets. We have established our EU regional office in Switzerland, expanding our commercial structure in the Americas, including U.S., Canada and Mexico, and building our commercial presence in Asia Pacific. In parallel, we will continue to partner with local policymaking bodies to advance supportive policy recommendations. This will be critical to ensuring the widespread access and capturing a significant share of the anticipated recurring market outlined today.

首先，我們正在擴大我們在優先市場的商業足跡。我們在瑞士設立了歐盟區域辦事處，擴大了我們在美洲（包括美國、加拿大和墨西哥）的商業結構，並在亞太地區建立了商業影響力。與此同時，我們將繼續與地方決策機構合作，推進支持性政策建議。這對於確保廣泛訪問和占據今天概述的預期經常性市場的重要份額至關重要。

We are also building brand awareness among health care professionals and consumers through a comprehensive marketing strategy to communicate our vaccine's strong data and key benefits. In an effort to position Novavax as a key player in a commercial market, we are also developing our commercial network and building relationships with key stakeholders such as pharmacies and purchasing groups.

我們還通過全面的營銷策略在醫療保健專業人士和消費者中建立品牌知名度，以傳達我們疫苗的強大數據和主要優勢。為了將 Novavax 定位為商業市場的主要參與者，我們還在開發我們的商業網絡，並與藥店和採購團體等主要利益相關者建立關係。

We will be transitioning to single-dose vials and expect to make available prefilled syringes in 2023 in order to enable easier administration and lower waste of doses, serving as a competitive advantage for our product. We believe ongoing execution of this global commercial strategy, coupled with our vaccines competitive product profile, will support our long-term success and solidify our role in the recurring COVID-19 market. I will now hand it over to Jim to discuss our financial results for the third quarter.

我們將過渡到單劑量小瓶，並預計在 2023 年提供預裝注射器，以便更容易給藥和減少劑量浪費，從而成為我們產品的競爭優勢。我們相信，這一全球商業戰略的持續執行，加上我們疫苗產品的競爭力，將支持我們的長期成功，並鞏固我們在反復出現的 COVID-19市場中的作用。我現在將它交給吉姆來討論我們第三季度的財務業績。

All right. Thank you, John. This afternoon, we announced our financial results for the third quarter of 2022. Details of our results can be found in our press release issued today and our 10-Q filing. I will begin by providing an overview of our third quarter 2022 total revenue performance, net income and cash position. Then I will discuss our quarterly results in additional detail as well as provide commentary on our refined full year 2022 revenue guidance.

好的。謝謝你，約翰。今天下午，我們公佈了 2022 年第三季度的財務業績。我們的業績詳情可以在今天發布的新聞稿和我們的 10-Q 文件中找到。我將首先概述我們 2022 年第三季度的總收入表現、淨收入和現金狀況。然後，我將更詳細地討論我們的季度業績，並對我們完善的 2022 年全年收入指引發表評論。

In the third quarter of 2022, we recorded $735 million in total revenue compared to $179 million in the prior year. Total revenue for the third quarter included $626 million in product sales based on 35 million doses sold by Novavax. Grant revenue of $106 million in the third quarter of 2022 includes revenue on the delivery of 3 million doses to the U.S. government and compares to $135 million in the prior year.

2022 年第三季度，我們的總收入為 7.35 億美元，而去年同期為 1.79 億美元。第三季度的總收入包括基於 Novavax 銷售的 3500 萬劑產品的 6.26 億美元產品銷售額。 2022 年第三季度的撥款收入為 1.06 億美元，其中包括向美國政府交付 300 萬劑疫苗的收入，而去年同期為 1.35 億美元。

Additionally, we recorded royalty and other revenue in the third quarter of 2022 of $2 million. Our cost of sales for the third quarter of 2022 were $435 million. I'll discuss this in a bit more detail on the next slide. R&D expense for the third quarter of 2022 were $304 million compared to $408 million for the comparable period in 2021. The decrease was primarily the result of a $98 million benefit from settlement of the manufacturing agreement.

此外，我們在 2022 年第三季度錄得 200 萬美元的特許權使用費和其他收入。我們 2022 年第三季度的銷售成本為 4.35 億美元。我將在下一張幻燈片中更詳細地討論這個問題。 2022 年第三季度的研發費用為 3.04 億美元，而 2021 年同期為 4.08 億美元。減少的主要原因是製造協議的結算帶來了 9800 萬美元的收益。

Additionally, we recorded selling, general and administrative expenses of $123 million in the third quarter of 2022 compared to $78 million in the third quarter of 2021. The increase in the period was primarily the result of activities in support of the commercialization of Nuvaxovid.

此外，我們記錄了 2022 年第三季度的銷售、一般和管理費用為 1.23 億美元，而 2021 年第三季度為 7800 萬美元。該期間的增加主要是支持 Nuvaxovid 商業化的活動的結果。

For the third quarter of 2022, we recorded a net loss of $169 million compared to a net loss of $322 million in the third quarter of 2021. And finally, we continue to maintain a full tax valuation allowance and we ended the third quarter of 2022 with $1.3 billion in cash.

2022 年第三季度，我們錄得 1.69 億美元的淨虧損，而 2021 年第三季度為 3.22 億美元的淨虧損。最後，我們繼續保持全額稅收估值津貼，我們在 2022 年第三季度結束了現金13億美元。

Please turn to Slide 35. Cost of sales for the third quarter of 2022 were $435 million. This amount includes $249 million related to excess obsolete or expired inventory and losses on firm purchase commitments. The recognition of these costs was driven by our efforts to align our supply and third-party future purchase commitments with anticipated demand for Nuvaxovid.

請轉到幻燈片 35。2022 年第三季度的銷售成本為 4.35 億美元。這一數額包括與過時或過期庫存過剩以及堅定採購承諾損失相關的 2.49 億美元。這些成本的確認是由於我們努力使我們的供應和第三方未來購買承諾與 Nuvaxovid 的預期需求保持一致。

If inventory sold for the third quarter was valued at expected standard cost, adjusted cost of sales for the period would have been approximately $444 million, an increase of $9 million as compared to cost of sales recognized. Nuvaxovid gross margins on sales to high-income countries are expected to be between 70% and 85% of product sales.

如果第三季度售出的存貨按預期標準成本估值，則該期間調整後的銷售成本約為 4.44 億美元，與已確認的銷售成本相比增加 900 萬美元。 Nuvaxovid 向高收入國家銷售的毛利率預計在產品銷售額的 70% 至 85% 之間。

As noted earlier, we are refining our full year 2022 total revenue guidance to approximately $2 billion, the low end of the previous guidance range of $2 billion to $2.3 billion. As a reminder, total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grant revenue, royalties and other revenue. We look forward to sharing additional updates as we progress in the upcoming quarters. With that, I'd like to turn it over to Stan to discuss our upcoming strategic priorities.

如前所述，我們正在將 2022 年全年總收入指引細化至約 20 億美元，這是之前 20 億至 23 億美元的指引範圍的低端。提醒一下，總收入反映了所有來源，包括 Novavax 的 Nuvaxovid 產品銷售、贈款收入、特許權使用費和其他收入。隨著我們在未來幾個季度取得進展，我們期待分享更多更新。有了這個，我想把它交給 Stan 來討論我們即將到來的戰略重點。

Thanks, Jim. So you turn the slide, please. With the strong third quarter reported today, we are pleased with the momentum we're generating across our business. Moving into the end of the year, we are focused on executing against our key strategic priorities, and these include delivering doses globally to achieve our revenue guidance, ongoing expansions to our label and supportive policy recommendations for Nuvaxovid and initiating our Phase II trial for our COVID-19 influenza combination vaccine and stand-alone influenza vaccine by the end of this year, which will enable a Phase III efficacy trial expected to start in 2023.

謝謝，吉姆。請轉動幻燈片。隨著今天公佈的強勁的第三季度，我們對我們在整個業務中產生的勢頭感到滿意。進入年底，我們將專注於執行我們的關鍵戰略優先事項，其中包括在全球範圍內提供劑量以實現我們的收入指導、持續擴大我們的標籤和對 Nuvaxovid 的支持性政策建議，以及啟動我們的 II 期試驗COVID-19 流感聯合疫苗和獨立流感疫苗將在今年年底前完成，這將使預計將於 2023 年開始的 III 期療效試驗成為可能。

So as we prepare for the upcoming winter COVID season as well as 2023 and beyond, we believe we are well positioned to be a leading provider of COVID-19 vaccines. And as you've heard today, through our data generated to date, we are confident in our prototype vaccines competitive profile, including its durability of immune responses, its ability to address a broad range of variants, its protection against infection and storage and handling benefits. We believe these differentiated factors, along with our ongoing label expansion. Global manufacturing and supply network will allow us to capture a meaningful share of the recurring COVID-19 market.

因此，在我們為即將到來的冬季 COVID 季節以及 2023 年及以後做準備時，我們相信我們有能力成為 COVID-19 疫苗的領先供應商。正如您今天所聽到的那樣，通過我們迄今為止生成的數據，我們對我們的原型疫苗的競爭優勢充滿信心，包括其免疫反應的持久性、應對廣泛變異的能力、對感染的保護以及儲存和處理好處。我們相信這些差異化因素，以及我們正在進行的標籤擴張。全球製造和供應網絡將使我們能夠在反復出現的 COVID-19 市場中佔據重要份額。

So thanks for your attention, and I'll now turn it over to the operator for Q&A.

所以感謝大家的關注，我現在將其轉交給接線員進行問答。

(Operator Instructions) And our first question today will come from Roger Samuel with Jefferies.

（操作員說明）我們今天的第一個問題將來自 Jefferies 的 Roger Samuel。

And congrats for the quarter. A couple from us. The first one is the variant-specific vaccine. So given the data you presented today, seems the bivalent have less immunogenicity against the monovalent. So just curious what is the plan for the variant-specific vaccine moving forward monovalent versus bivalent? And what kind of variant you plan to do moving forward, given so we are having new variants almost every once in a while? I'll have a couple of follow-ups.

並祝賀本季度。我們的一對。第一個是變體特異性疫苗。因此，鑑於您今天提供的數據，似乎二價藥物對單價藥物的免疫原性較低。所以很好奇變體特異性疫苗在單價和二價之間的發展計劃是什麼？考慮到我們幾乎每隔一段時間就會有新的變體，您打算向前推進什麼樣的變體？我將進行一些跟進。

This is Filip. I mean, Stan and John both mentioned that we do plan to develop a variant vaccine as well as a bivalent to service market as needed. But your observation is right. I mean, what we saw is that our responses against BA.5 were very good. And the transmission or the amount of infections caused by BA.5 is plummeting. So it's less of a relevant strain for us to pursue.

這是菲利普。我的意思是，Stan 和 John 都提到我們確實計劃根據需要開髮變體疫苗以及服務市場的二價疫苗。但你的觀察是對的。我的意思是，我們看到的是我們對 BA.5 的回應非常好。由 BA.5 引起的傳播或感染量正在直線下降。因此，我們追求的相關壓力較小。

So we're actually shifting plans a little bit, and we're pushing forward with the BQ.1.1 variant. And we're going to develop that up and take that into the clinic and also formally that is a bivalent product. Whether -- time will tell whether that's required or whether the customers want such a vaccine. But the time lines will allow us to bring that really to the market in a time when the Southern Hemisphere should be surging in the second quarter of next year.

所以我們實際上正在稍微改變計劃，我們正在推進 BQ.1.1 變體。我們將對其進行開發並將其帶入臨床，並且正式將其作為二價產品。是否——時間會告訴我們是否需要這種疫苗，或者客戶是否需要這種疫苗。但時間線將使我們能夠在明年第二季度南半球應該激增的時候真正將其推向市場。

Great. Okay. All right. So the next question relates to the financials. Just curious what is the -- I know you're reaffirming the guidance for second half to the entire year for $2 billion. Just curious, in 4Q so far, what have you been seeing? And what's the preorder looking like? And how did that compare to the 3Q you just reported?

偉大的。好的。好的。所以下一個問題與財務有關。只是好奇是什麼——我知道你重申了下半年到全年 20 億美元的指導。只是好奇，到目前為止，在第四季度，你看到了什麼？預購是什麼樣子的？與您剛剛報告的第三季度相比如何？

Yes, John Trizzino. We're confident with our order book at this point through the end of the year. And I think that we're being conservatively cautious about what deliveries we think we'll be able to make toward the end of the year as we get into the holiday season and product being shipped out and received during that period of time. So I think the guidance is still strong and just adjusting and refining a bit down to the low end of the range.

是的，約翰·特里齊諾。我們對今年年底的訂單充滿信心。而且我認為，隨著我們進入假日季節以及在這段時間內發貨和接收的產品，我們對我們認為我們能夠在年底交付的貨物持謹慎態度。所以我認為指導仍然很強，只是稍微調整和完善到範圍的低端。

Awesome. Okay. Maybe just last one from us. Just looking ahead for 2023 and 2024, if I calculate this value, probably have around like 150-plus APA -- 150-plus doses for APA. So just curious how should we think about the rest of the APA and when they will start to fulfill in the coming years.

驚人的。好的。也許只是我們的最後一個。展望 2023 年和 2024 年，如果我計算這個值，可能會有大約 150 多劑 APA——150 多劑 APA。所以很好奇我們應該如何考慮 APA 的其餘部分以及它們將在未來幾年開始履行的時間。

Yes. It's really difficult to predict what 2023 is going to look like and by way, hesitate to even whisper at guidance at the moment. I think with the transition to more of a commercial market, looking at variant strains or bivalent strains as a possibility and then thinking about what those markets will look like in policy recommendations.

是的。真的很難預測 2023 年會是什麼樣子，順便說一句，目前甚至不敢在指導下低聲說。我認為隨著向更多商業市場的過渡，將變異菌株或二價菌株視為一種可能性，然後考慮這些市場在政策建議中的樣子。

As I think -- you've even heard from some of the other manufacturers, it's a little bit challenging to assess at the moment. I think what will happen as we come through the next couple of months, look at what our book of business looks like and it still remains strong, I think we'll have a determination about whether it's existing APAs or incremental business coming into 2023.

正如我所想——你甚至從其他一些製造商那裡聽說過，目前評估有點困難。我認為在接下來的幾個月裡會發生什麼，看看我們的業務簿是什麼樣的，它仍然很強勁，我認為我們將確定是現有的 APA 還是進入 2023 年的增量業務。

I think we -- the messages that I make should be reinforced, which is that the virus is not going away. We still have variant strains emerging. It looks like we're going to have a Southern Hemisphere boosting season as well as Northern Hemisphere in the fall again. And I think this overall market size is going to be larger than the existing flu market.

我認為我們——我發出的信息應該得到加強，那就是病毒不會消失。我們仍然有變異菌株出現。看起來我們將在秋季再次迎來南半球和北半球的提振季。我認為這個整體市場規模將大於現有的流感市場。

So while we are -- we would rather not be thinking about the downside of the virus, we have to be prepared, and that's what the purpose of the vaccine is. And I think more will come in the next few months.

因此，儘管我們——我們寧願不考慮病毒的負面影響，但我們必須做好準備，這就是疫苗的目的。我認為未來幾個月會有更多。

And our next question will come from Georgi Yordanov with Cowen and Company.

我們的下一個問題將來自 Cowen and Company 的 Georgi Yordanov。

Congratulations on the progress. So a few on our end. The first one, I guess, for Filip, I'm not sure if I missed that, but one of the most crucial pieces of data that we thought was missing from this morning's release was the full increase in neutralization titers for the 3 different products that you looked at. This has been basically kind of like the main factor that regulators and the scientific community has been looking at.

祝賀你的進步。所以我們這邊有幾個。第一個，我想，對於 Filip，我不確定我是否錯過了，但我們認為今天早上發布的數據中缺少的最重要的數據之一是 3 種不同產品的中和滴度的全面增加你看過的。這基本上有點像監管機構和科學界一直在關注的主要因素。

So we thought that, that would be interesting to have. And then we have a couple of follow-ups. I guess the question is, can you provide that on the call? Or if not, when can we expect to see it?

所以我們認為，擁有它會很有趣。然後我們有幾個後續行動。我想問題是，你能在電話中提供嗎？或者如果沒有，我們什麼時候可以看到它？

Yes. We haven't prepared that data for disclosure today, and I'm not sure we have specific plans of when we would disclose that. I mean the full increase certainly is interesting. That shows the ability of a product to boost. But in my mind, what's actually more relevant is the absolute titers achieved after you boost because that's going to translate directly into protection. Especially if you think about the breadth that we demonstrated today, I have a lot of confidence that what we have in hand now is relevant to the currently circulating strains.

是的。我們今天還沒有準備好要披露的數據，我不確定我們有什麼時候披露這些數據的具體計劃。我的意思是全面增加肯定很有趣。這顯示了產品提升的能力。但在我看來，實際上更相關的是在你加強後達到的絕對效價，因為這將直接轉化為保護。特別是如果您考慮我們今天展示的廣度，我非常有信心我們現在所掌握的與當前流行的毒株相關。

Our point that Greg, my boss loves to make is, we're not claiming this as universal vaccine. We're ever vigilant and we test each of the new variants that come up to assure ourselves to immune sponsors that we're inducing are really relevant for that. So I think you're going to have to hold on until we come up with -- until we announce a plan of how to announce additional data on the study.

我的老闆格雷格喜歡表達的觀點是，我們並沒有聲稱這是萬能疫苗。我們一直保持警惕，我們測試了每一個出現的新變體，以確保我們誘導的免疫贊助商與此真正相關。所以我認為你必須堅持到我們想出 - 直到我們宣佈如何公佈有關研究的額外數據的計劃。

Got it. I guess like the only the power issues that basically a lot of our consultants see the correlates of antibody protection is quite problematic in the community and just because we haven't had enough data. So that's why it will be important to see that data from you specifically to full increase.

知道了。我想我們的很多顧問基本上都認為與抗體保護相關的唯一電源問題在社區中存在很大問題，只是因為我們沒有足夠的數據。因此，這就是為什麼特別要看到您的數據全面增加很重要的原因。

Let me just comment on that because I think you know form publication, and that wasn't developed by us. That was developed by the MS in USG and in that publication, they found that the better core protection for our specific vaccine was actually IgG. And it's a different from what they found for other vaccines where they thought that neutralizing antibody was a better protection. But I showed you data today on pseudoneuts for BA.5 and those were really comparable among the treatment groups. And that gives us the confidence to believe that our prototype vaccine we have in hand now is relevant to what's circulating.

讓我對此發表評論，因為我認為您知道表格發布，而這不是我們開發的。這是由 USG 的 MS 開發的，在該出版物中，他們發現對我們的特定疫苗更好的核心保護實際上是 IgG。這與他們在其他疫苗中發現的不同，他們認為中和抗體是更好的保護。但我今天向您展示了 BA.5 偽中子的數據，這些數據在治療組之間確實具有可比性。這讓我們有信心相信我們現在手頭的原型疫苗與正在流行的疫苗有關。

Got it. And then maybe specifically on the FDA label. Maybe can you walk us through the steps of how do you think you can kind of like remove that restriction is only being used as a first booster? I guess you've presented some of the lost consistency data that supports that. So if you can just help us understand the time lines to when could we expect that to happen?

知道了。然後可能專門在 FDA 標籤上。也許你能告訴我們你認為你可以如何取消限制只被用作第一個助推器的步驟嗎？我想您已經提供了一些支持這一點的丟失的一致性數據。所以，如果你能幫助我們了解我們預計什麼時候會發生的時間表？

Yes, that's right. I mean this is what we were asked to develop and we had been developing is where it looks like when we use our booster not only is the first boost, but it's a second boost. And that's the data I showed you both from study 307 and 311, and that data is being really prepared now for our submission to the FDA.

是的，這是正確的。我的意思是這就是我們被要求開發的東西，我們一直在開發的是當我們使用我們的助推器時看起來不僅是第一次助推器，而且是第二次助推器。這就是我向你們展示的來自研究 307 和 311 的數據，這些數據現在正在真正準備好提交給 FDA。

This is kind of a unique position we are in the U.S. As you know, globally, we don't have a label restrictions on the first versus second or third or subsequent boosts, be that as it may. The data is being pulled together and is being prepared for submission. I want to perhaps remind you that some of the studies that the FDA does not like to consider like our 101 study did, in fact, have multiple boosts up to 4 doses, and that has been considered by other regulatory agencies.

這是我們在美國的獨特地位。如您所知，在全球範圍內，我們對第一次與第二次或第三次或隨後的提升沒有標籤限制，儘管如此。正在收集數據並準備提交。也許我想提醒您，FDA 不喜歡考慮的一些研究，例如我們的 101 研究，實際上有多次加強，最多 4 劑，其他監管機構也考慮過這一點。

Got it. And then finally, a question just on the commercial side. As we kind of start to think about the potential commercial market transition in 2023, maybe, John, can you talk about like when this contracting usually started? Have you had any initial conversations? Some of your competitors have mentioned that they are in conversations with the EU and other markets and specifically for the U.S., sorry to be too U.S.-centric, but our understanding is in order to be covered by a commercial insurer, you would have to get full approval by the FDA.

知道了。最後，一個關於商業方面的問題。當我們開始考慮 2023 年潛在的商業市場轉型時，也許，約翰，你能談談這種合同通常是什麼時候開始的嗎？你有過任何初步的談話嗎？您的一些競爭對手提到他們正在與歐盟和其他市場進行對話，特別是針對美國，很抱歉過於以美國為中心，但我們的理解是為了獲得商業保險公司的承保，您必須獲得FDA 的完全批准。

Can you update us on do you believe you can get there in time for those contract negotiations? And where do you stand with the full BLA submission?

你能告訴我們你相信你能及時到達那裡進行那些合同談判嗎？您如何看待完整的 BLA 提交？

Yes, Georgi, those are great questions. Thank you. So listen, each one of those contract negotiations is kind of different around the globe. Right now, we're still under EU commission discussions, and it could be that through '23. That's the basis for the existing APAs and any reordering that would come. Similarly in other countries like Australia and Canada, we'll have some unique contract and we likely expect that those countries will stay under the existing kind of APA structure with the opportunity for incremental purchases as well.

是的，Georgi，這些都是很好的問題。謝謝你。所以聽著，這些合同談判中的每一個在全球範圍內都是不同的。現在，我們仍在歐盟委員會的討論中，可能會持續到 23 年。這是現有 APA 和任何重新排序的基礎。同樣，在澳大利亞和加拿大等其他國家/地區，我們將擁有一些獨特的合同，我們可能希望這些國家/地區將保持在現有的 APA 結構下，並有機會進行增量採購。

So we're in constant communication around the globe where we're already engaged and talking to those procurement authorities about what that's going to look like. In the U.S., in particular, we will not have any restrictions with the private payers or the government payers with the EUA in place. Those are conversations that we've already had and are confident in our positioning while we're under the EUA.

因此，我們在全球範圍內不斷溝通，我們已經參與其中，並與那些採購當局討論這將是什麼樣子。特別是在美國，有了 EUA，我們不會對私人付款人或政府付款人有任何限制。這些是我們在 EUA 下已經進行過的對話，並且對我們的定位充滿信心。

So the EUA will have some very minor implications to us who ultimately will be filing for the BLA during the course of next year. But not having the BLA fully approved, will not restrict us in the fall booster campaign.

因此，EUA 對我們最終將在明年期間申請 BLA 的影響非常小。但是沒有 BLA 的完全批准，不會限制我們在秋季助推器活動中。

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

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

So maybe just following up on that last throw-off questions. So John, in context of doses that are remaining as part of, for example, the U.S. APA. Is there an absolute minimum that you have to satisfy before you kind of work towards the private commercial payer kind of setting? Is there something that has to happen as part of the APA before you could play out the other vaccines in the private market? And then I have a couple of follow-ups.

所以也許只是跟進最後一個拋出的問題。所以約翰，在作為美國 APA 的一部分仍然存在的劑量的背景下。在您為私人商業付款人類型的設置工作之前，您是否必須滿足絕對最低要求？在您可以在私人市場上使用其他疫苗之前，作為 APA 的一部分必鬚髮生什麼事情嗎？然後我有幾個後續行動。

I don't think I quite caught all that, Mike. But are you referring to the ex-U.S. APAs or the EUA in the U.S.?

我不認為我完全明白了，邁克。但你指的是前美國嗎？美國的 APA 或 EUA？

Excuse me, I was referring to the U.S. APA. The current 110 million doses contract that you have, is there some sort of a minimum you have to satisfy before we can sort of think of a private market in 2023 and beyond?

對不起，我指的是美國 APA。您目前擁有的 1.1 億劑合同，在我們考慮 2023 年及以後的私人市場之前，您是否必須滿足某種最低要求？

Yes. No. I mean, while that contract is still in place, I think likely we're going to see a movement to traditional procurement. And again, it's really hard to say when. But if we're keying off of what happened this year, you would think that there would be a full vaccination campaign. We'll learn probably early in the year about what that process is going to look like, what strains are being expected, what vaccine format the U.S. government is going to want.

是的。不，我的意思是，雖然該合同仍然存在，但我認為我們可能會看到傳統採購的轉變。再一次，真的很難說什麼時候。但如果我們不談今年發生的事情，你會認為會有一場全面的疫苗接種運動。我們可能會在今年年初了解該過程將是什麼樣子，預計會有哪些毒株，美國政府想要什麼樣的疫苗形式。

So I think that's why the comments I made earlier are let's kind of stay tuned through the balance of the year and into Q1 as we see how that unfolds, whether the U.S. government will fund the purchase of additional vaccine or they will rely on the public-private market to take that over during the course of 2023. So I think it's stay tuned. But I think likely, you're going to see procurement taking place in the commercial market in '23.

所以我認為這就是為什麼我之前發表的評論讓我們在今年餘下時間和第一季度保持關注，因為我們會看到它是如何展開的，美國政府是否會資助購買額外的疫苗，或者他們將依賴公眾-私人市場將在 2023 年期間接管它。所以我認為它會繼續關注。但我認為您很可能會在 23 年看到商業市場上的採購。

Okay. And then on the fourth quarter, delivery estimates that you have, it looks like you only need, I think, an incremental 15 million doses to get to that $2 billion refined guidance. Can you confirm that what countries you could get that from? Is that basically EU, U.K. and Australia and New Zealand? Is that essentially the countries and customers that just -- can you just clarify that?

好的。然後在第四季度，你所擁有的交付估計，我認為你似乎只需要增加 1500 萬劑就可以達到 20 億美元的精確指導。您能否確認您可以從哪些國家/地區獲得這些信息？基本上是歐盟、英國、澳大利亞和新西蘭嗎？這本質上是那些國家和客戶——你能澄清一下嗎？

Well, I think the guidance is kind of clarifying that. I don't think we're going to give specific doses by country. But it will likely be across all of our APAs in varying dose amounts, but we're not going to disclose what those specifics are country by country.

好吧，我認為指南在某種程度上澄清了這一點。我認為我們不會按國家/地區提供特定劑量。但它可能會以不同的劑量出現在我們所有的 APA 中，但我們不會按國家/地區披露這些細節。

Understood. And then on the R&D expenses, just quickly, it looks like it did come down quarter-over-quarter, but it was a result of a manufacturing agreement. Can you speak to what leverage you may have going forward? As you think about fourth quarter, but also next year and recognizing that you're being very strategic about investing behind trials and scaling up for the variant-specific vaccine?

明白了。然後在研發費用方面，很快，它看起來確實比上一季度有所下降，但這是製造協議的結果。你能談談你未來可能有什麼影響力嗎？當你考慮第四季度，還有明年，並認識到你在投資試驗和擴大特定變體疫苗方面非常具有戰略意義？

Certainly. When you look at our R&D expenses this quarter, you're correct, that was about an $90 million benefit. So of course, that would taking you up to about $400 million. We do expect some continued decrease in R&D as we bring more of our manufacturing capabilities online, capitalize on the inventory, including our CZ plant. So you'll see some trending down there over time.

當然。當您查看我們本季度的研發費用時，您是對的，這大約是 9000 萬美元的收益。所以當然，這會讓你花費大約 4 億美元。我們確實預計，隨著我們將更多製造能力上線、利用庫存（包括我們的 CZ 工廠），研發會繼續減少。所以隨著時間的推移，你會看到一些趨勢。

I would say that in this period as well, we had a bit of an offset of some ins and outs of the benefit from capitalizing our CZ plant. And then we also had some, I'm going to call it, R&D-related manufacturing activities that we wrote off that I wouldn't expect in future periods. So you'd be correct to see a trending down R&D in some future periods.

我想說的是，在這段時間裡，我們也抵消了 CZ 工廠資本化帶來的一些好處。然後我們還有一些，我將稱之為，我們註銷的與研發相關的製造活動，我預計在未來期間不會發生。因此，您認為未來某些時期的研發呈下降趨勢是正確的。

Our next question will come from Eric Joseph with JPMorgan.

我們的下一個問題將來自摩根大通的埃里克約瑟夫。

This is Hannah on for Eric. Just a few from us. So first, I was just wondering if you could talk about the impact of COGS that can occur from migrating Nuvaxovid to a single administration sense format? And relatedly, what would you need to do in terms of additional supplemental approvals to getting that strains product out? And then also just on the front, just wondering how your thoughts have evolved as it relates to reentering the RSV and given the success of the perfusion competitor?

這是埃里克的漢娜。就我們幾個。所以首先，我只是想知道您是否可以談談將 Nuvaxovid 遷移到單一管理感知格式可能產生的 COGS 的影響？與此相關的是，在獲得該菌株產品的額外補充批准方面，您需要做什麼？然後也在前面，只是想知道你的想法是如何演變的，因為它與重新進入 RSV 和灌注競爭者的成功有關？

You're really hard to hear in the first part of that question. Would you mind just kind of repeating, please?

在這個問題的第一部分，你真的很難聽到。請你介意重複一遍好嗎？

So first part of the question, impact-related COGS from the strains product. And then also what would it take in terms of submitting approval for getting that out -- getting that product out?

所以問題的第一部分是菌株產品中與影響相關的 COGS。然後還需要什麼才能提交批准以將其推出 - 將該產品推出？

Yes. So we would expect for those prefilled syringe impact that we would see that happening later in the second half of the year, specifically in those markets in the Northern Hemisphere. So I think we would expect to see some reduction in vial size, total amount of doses in vial in Southern Hemisphere, but certainly moving toward prefilled syringe or unit dose vials in the second half of the year.

是的。因此，我們預計對於那些預裝注射器的影響，我們會在今年下半年晚些時候看到這種情況發生，特別是在北半球的那些市場。因此，我認為我們預計南半球的藥瓶尺寸、藥瓶總量會有所減少，但肯定會在今年下半年轉向預裝注射器或單位劑量藥瓶。

And then your thoughts on entering RSVs given the success of perfusion competitors?

鑑於灌注競爭對手的成功，您對進入 RSV 的想法是什麼？

RSV. Yes, well, I think, look, it's something that a particularly key interest to us. As we've mentioned before, that technology platform for our recombinant protein nanoparticle as well as adjuvant is robust and beneficial as we're seeing it in our COVID-19 vaccine. We've learned significant lessons over the course of the last couple of years about how to leverage that technology platform.

呼吸道合胞病毒。是的，我認為，看，這是我們特別感興趣的事情。正如我們之前提到的，我們的重組蛋白納米顆粒和佐劑的技術平台是強大且有益的，正如我們在 COVID-19 疫苗中看到的那樣。在過去幾年中，我們在如何利用該技術平台方面吸取了重要教訓。

And while there's good data from competition in RSV, I think we have an opportunity to have even better data given our technology platform in the context of multiple doses and the use of our adjuvant. So stay tuned for more details relative to RSV in our pipeline.

雖然 RSV 競爭中有很好的數據，但我認為我們有機會在多劑量和使用我們的佐劑的背景下，根據我們的技術平台獲得更好的數據。因此，請繼續關注我們管道中與 RSV 相關的更多詳細信息。

And our next question will come from Alec Stranahan with Bank of America.

我們的下一個問題將來自美國銀行的 Alec Stranahan。

Just a couple from us. First on BA.5, could you help withdraw a line between the pseudovirus GMT response that you showed with the prototype Nuvaxovid for BA.5 to what you saw in PREVENT-19? Just wondering if GMT is declining on an absolute basis and how this may correlate with protection.

我們只有一對夫婦。首先在 BA.5 上，你能幫忙在你用原型 Nuvaxovid 為 BA.5 展示的假病毒 GMT 響應與你在 PREVENT-19 中看到的響應之間劃一條線嗎？只是想知道格林威治標準時間是否在絕對基礎上下降，以及這與保護有何關聯。

And similarly, I believe there was also a BA.5 specific vaccine and bivalent in the Phase III study that you presented today. So any guidance on when you'd update the market on that data would be helpful. And secondly, maybe one for Jim. Looking at your debt commitments to CEPI and the convertible note as well as potential for repayments to the U.K. and Gavi, which cumulatively is not a significant amount of cash potentially on the line. Could you just speak to your view on the liquidity heading into next year? I know you're roughly at $1.3 billion now.

同樣，我相信在您今天介紹的 III 期研究中還有一種 BA.5 特異性疫苗和二價疫苗。因此，任何關於何時根據該數據更新市場的指導都會有所幫助。其次，也許是給吉姆的。查看您對 CEPI 和可轉換票據的債務承諾，以及對英國和 Gavi 的還款潛力，這些可能累積起來並不是一筆可觀的現金。您能否談談您對明年流動性的看法？我知道你現在大約有 13 億美元。

All right, Alex. Listen, thanks for your question. We ended the quarter with $1.3 billion. We are looking forward to February of next year is the time when, of course, our convert, the $325 million, comes due, we feel like we have ample cash flow to either retire that convert for cash or we'll monitor market conditions, consider what we might do there.

好吧，亞歷克斯。聽著，謝謝你的問題。我們以 13 億美元結束了本季度。我們期待著明年 2 月是我們轉換的 3.25 億美元到期的時候，我們覺得我們有足夠的現金流來退休，轉換為現金，或者我們將監控市場狀況，考慮我們可能在那裡做什麼。

When it comes to Gavi, because you mentioned that one, and I think that's an important one for clarification. We received 700 million from Gavi COVAX related initially for an upfront for our commitment, 350 million doses. And then, of course, the other 350 million upon approval by the World Health Organization. We do not believe Gavi has any right to a return of that capital. So for that reason, we would put that off to the side.

談到全球疫苗免疫聯盟，因為你提到了那個，我認為這是一個需要澄清的重要問題。我們最初從 Gavi COVAX 相關機構收到了 7 億美元，作為我們承諾的 3.5 億劑預付款。然後，當然還有世界衛生組織批准的另外 3.5 億。我們認為 Gavi 無權要求返還該資本。因此，出於這個原因，我們會把它放在一邊。

And then with respect to some of the other puts and takes of, call it, potential returns of capitals, we'll continue to provide updates on our cash flow as we guide into next year, but we go into this with great confidence. And our commercial launch in Nuvaxovid and what that means for operating cash flow.

然後關於其他一些投資和投資，稱之為潛在的資本回報，我們將繼續提供我們明年的現金流更新，但我們對此充滿信心。我們在 Nuvaxovid 的商業發布以及這對運營現金流意味著什麼。

And maybe just a bit of commentary about the pseudo-neuts, I mean the data I presented you today is preliminary data. That's being confirmed in a validated assay and we'll have those results soon. And they'll be more able to compare between the BA.5 versus the other subvariants in the prototype. And there's a vial assay. And there is a lot of variability in the results that you can get from that. But still, we are quite pleased to see the lows we got. It was within the levels that are thought to be protected at least by the NIH protection analysis.

也許只是關於偽中子的一些評論，我的意思是我今天向您展示的數據是初步數據。這在經過驗證的檢測中得到了證實，我們很快就會得到這些結果。他們將更能夠比較 BA.5 與原型中的其他子變體。還有一個小瓶化驗。您可以從中獲得的結果有很多可變性。但是，我們仍然很高興看到我們遇到的低谷。它處於被認為至少受 NIH 保護分析保護的水平之內。

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

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

Congrats on a fantastic revenue quarter. Just perhaps a question for John. You had mentioned one thing that still remains underappreciated, in my opinion, is the advantages that you have for Nuvaxovid as far as storage and distribution. Now thinking down the road, that advantage probably is going to continue to be there. What are you seeing as far as competitors and their storage capabilities and what they're changing and what the market may be thinking as far as down the road in the storage of the mRNA vaccines?

祝賀一個出色的收入季度。也許只是約翰的問題。在我看來，您提到的一件事仍未得到充分重視，那就是您對 Nuvaxovid 在存儲和分銷方面的優勢。現在想想，這種優勢可能會繼續存在。就競爭對手及其存儲能力而言，您看到了什麼？他們正在發生什麼變化？就 mRNA 疫苗的存儲而言，市場可能會怎麼想？

And after that, how do you think their capabilities as far as manufacturing, which they had initially been interested in ramping up in these territories that are lower income might be something that's -- helps them up with their commercial viability of mRNA vaccines is changing. Any insight you could provide would be helpful.

在那之後，你如何看待他們在製造方面的能力，他們最初有興趣在這些收入較低的地區擴大生產能力，這可能會幫助他們提高 mRNA 疫苗的商業可行性正在發生變化。您可以提供的任何見解都會有所幫助。

Yes. Vernon, good question. As I briefly mentioned in the presentation, we indeed still have a significant advantage in the refrigerator stability of our product. And then, of course, we would be moving to a smaller dose presentation and ultimately the prefilled syringes, which is yet a significant advancement. It's unclear where the competition is going and will remain to see what they're doing.

是的。弗農，問得好。正如我在演示中簡要提到的，我們在產品的冰箱穩定性方面確實仍然具有顯著優勢。然後，當然，我們將轉向更小的劑量呈現，並最終轉向預裝注射器，這仍然是一個重大進步。目前尚不清楚比賽的進展情況，並將繼續觀察他們在做什麼。

But at least for the moment, we know that they're still shipping frozen multi-dose vials that requires storage up and vial still before it's used, falling and then a fairly short durability, I'm sorry, stability of product after it's filled. So we'll continue to see that advantage. We think for some period into the future.

但至少就目前而言，我們知道他們仍在運輸冷凍多劑量小瓶，這些小瓶需要儲存起來，小瓶在使用前仍然會掉落，然後耐用性相當短，對不起，產品灌裝後的穩定性.所以我們將繼續看到這種優勢。我們考慮未來的某個時期。

And certainly, into -- for our other partners into low and upper middle-income markets where freezer capabilities are limited is an advantage for us as well. So thanks for pointing that out and we'll have to keep an eye on what happens with whatever they are able or unable to do with mRNA vaccines.

當然，對於我們的其他合作夥伴來說，進入冷凍能力有限的中低收入市場對我們來說也是一個優勢。因此，感謝您指出這一點，我們將不得不密切關注他們能夠或不能對 mRNA 疫苗做什麼。

And as far as the market dynamic is concerned, are you seeing any difference or changes in the end user as far as their thinking of, and storage and perhaps future needs for mRNA vaccines versus yours?

就市場動態而言，您是否看到最終用戶在 mRNA 疫苗的想法、存儲以及未來需求方面與您的有什麼不同或變化？

Yes, I think that's -- our interest in getting to the commercial markets, I think you'll see the health care providers then having some more optionality to access an easier-to-use presentation. And so that's certainly one aspect that we're going to be pursuing in the U.S. and EU markets.

是的，我認為這是——我們對進入商業市場的興趣，我認為你會看到醫療保健提供者有更多的選擇權來訪問更易於使用的演示文稿。因此，這肯定是我們將在美國和歐盟市場追求的一個方面。

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

這將結束我們的問答環節。我想將會議轉回給 Stan 聽取任何閉幕詞。

Thank you, operator. I appreciate the time everybody has spent taking this call. It's been a very big and important quarter for us. We've made a lot of advantages on every front. And I look forward to showing you more of the same in the coming quarters. Thank you.

謝謝你，運營商。我感謝大家花時間接聽這個電話。對我們來說，這是一個非常重要的季度。我們在各個方面都取得了很多優勢。我期待在接下來的幾個季度向您展示更多相同的內容。謝謝你。

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

會議現已結束。感謝您參加今天的演講。此時您可以斷開線路。