Novavax Inc (NVAX) 2022 Q2 法說會逐字稿

Good morning, and welcome to Novavax Second Quarter 2022 Financial Results and Operational Highlights Conference Call. (Operator Instructions) Please note, this event is being recorded.

早上好，歡迎來到 Novavax 2022 年第二季度財務業績和運營亮點電話會議。 （操作員說明）請注意，此事件正在記錄中。

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

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

Good afternoon, and thank you all for joining us today to discuss our second 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 年第二季度的運營亮點和財務業績。宣布我們結果的新聞稿目前可在我們的網站 novavax.com 上獲得，本次電話會議的音頻檔案將於今天晚些時候在我們的網站上提供。

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 revenue and gross margin; 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; the global market opportunities for our vaccine candidates; the future availability of our vaccine candidates and key upcoming milestones.

在我們開始準備評論之前，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 年計劃和前景相關的信息，以及包括收入和毛利率在內的財務指導；我們候選疫苗的持續開發，包括預期的試驗時間和結果；未來監管備案和行動的範圍、時間安排和結果；我們候選疫苗的功效、安全性和預期用途；我們的候選疫苗的全球市場機會；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 second 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. 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.

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，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。有關這些因素的其他信息出現在我們今天下午發布的幻燈片中有關前瞻性陳述的警告說明標題下，以及我們最近提交給證券的 10-K 表格和第二季度 10-Q 表格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 SEC 提交的文件中獲取。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。

Please turn to Slide 3. During this conference 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. Any non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measure in a table available in the Investors section of our website at novavax.com.

請轉到幻燈片 3。在本次電話會議中，為了提高我們運營業績的透明度，我們參考了某些涉及調整 GAAP 結果的非 GAAP 財務指標。提出的任何非 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 財務措施相媲美。本次電話會議中提及的任何非 GAAP 財務指標均與我們網站 novavax.com 投資者部分的表格中最直接可比的 GAAP 財務指標進行核對。

Please turn to Slide 4. Joining me today is Stan Erck, President and CEO, who will provide an overview of recent achievements and our upcoming strategic priorities; additionally, Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical development updates across our pipeline; and John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on the status of our global COVID-19 vaccine rollout, our recent progress in our label expansion and our global commercial strategy; finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview 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.

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，他將概述最近的成就和我們即將到來的戰略重點；此外，首席醫療官 Filip Dubovsky 博士將討論我們整個管道的臨床開發更新；首席商務官兼首席商務官 John Trizzino 將提供有關我們全球 COVID-19 疫苗推出的最新情況、我們在標籤擴展方面的最新進展以及我們的全球商業戰略；最後，首席財務官兼財務主管 Jim Kelly 將概述我們的財務業績。研發總裁 Greg Glenn 博士也將在今天電話會議結束時參加問答環節。

I'd now like to hand the call over to Stan. Please turn to Slide 5.

我現在想把電話交給斯坦。請轉到幻燈片 5。

Thanks, Silvia, and thanks to everyone for joining us today to discuss Novavax's second quarter results. Once again, we have had a very significant quarter of achievements. We continue to take -- make the transition into a commercial company, and we continue to see more and more evidence that our vaccine platform is second to none. In the next few minutes, I and my team will share with you some of the many achievements and breakthroughs that are transforming the company.

謝謝 Silvia，也感謝大家今天加入我們討論 Novavax 第二季度的業績。再一次，我們取得了非常顯著的四分之一成就。我們繼續向商業公司轉型，我們繼續看到越來越多的證據表明我們的疫苗平台是首屈一指的。在接下來的幾分鐘內，我和我的團隊將與您分享正在改變公司的眾多成就和突破。

While we do that, let me take a moment to address what is probably the most visible aspect of our earnings report. Our revenue for the quarter came in well below anyone's projections. And with respect to all of 2022, we're expecting to fall short of our earlier projections. For the quarter, revenue was $186 million, a significant shortfall from both the first quarter results, and as I said, from our expectations. The shortfall was a result of a couple of issues, one of which is short term, the timing of our shipments to Europe. The other is a broader issue and will take some time to work through, and this is our changes in expectations from 2 major markets, the U.S. and the COVAX Facility.

在我們這樣做的同時，讓我花點時間來談談我們收益報告中可能最明顯的方面。我們本季度的收入遠低於任何人的預期。對於 2022 年全年，我們預計將達不到我們之前的預測。本季度的收入為 1.86 億美元，與第一季度的業績以及我們的預期相比都存在顯著差距。短缺是由幾個問題造成的，其中一個是短期的，即我們向歐洲發貨的時間。另一個是更廣泛的問題，需要一些時間來解決，這是我們對美國和 COVAX 設施這兩個主要市場的預期變化。

Globally, and particularly with respect to COVAX, there was a surge in supply. And when coupled with challenges COVAX had with the distribution into low- and middle-income countries, this limited the need for them to order contracted product from us and other vaccine manufacturers.

在全球範圍內，特別是在 COVAX 方面，供應激增。再加上 COVAX 在向低收入和中等收入國家分銷時遇到的挑戰，這限制了他們從我們和其他疫苗製造商那裡訂購合同產品的需求。

In the case of the U.S., I believe we were late to the market, and U.S. vaccination was driven by what was available and shown to work, mRNA vaccines. In addition, now that we are approved for primary vaccination, we are not yet approved for adolescents and boosting, which are critical indications, and we are making our way through this regulatory process. We are hopeful that we can get through this in days and weeks, but the absence of these indications slows the global rollout of our vaccine.

就美國而言，我相信我們進入市場的時間很晚，而美國的疫苗接種是由現有的並證明有效的 mRNA 疫苗驅動的。此外，既然我們已獲准用於初級疫苗接種，我們尚未獲准用於青少年和加強免疫，這是關鍵的適應症，我們正在通過這一監管程序。我們希望我們能在幾天和幾週內度過難關，但缺乏這些跡象會減緩我們疫苗的全球推廣速度。

Although there have been and will continue to be many ups and downs in these markets, we are now projecting that we will have no new revenues in '22 from the U.S. and from COVAX. Originally, we had planned to have revenue from these 2 markets arising from the sale of 110 million and 350 million doses, respectively.

儘管這些市場已經並將繼續出現許多起伏，但我們現在預計，22 年我們將不會有來自美國和 COVAX 的新收入。最初，我們計劃從這兩個市場分別獲得 1.1 億劑和 3.5 億劑的銷售收入。

In terms of where we go from here, I'm happy to say that just since July 1, we have filled over $400 million in revenue. While we're talking about the second quarter to date, this was such an extraordinary beginning to quarter 3 that I want to tell you what we have done through today.

就我們的發展方向而言，我很高興地說，自 7 月 1 日以來，我們已經完成了超過 4 億美元的收入。雖然我們談論的是迄今為止的第二季度，但這是第三季度的一個非凡的開始，我想告訴你我們今天所做的一切。

From an operational standpoint, we have again had one of the most productive and transformation -- transformative quarters in our history. In the U.S., immunizations are currently underway with our COVID-19 vaccine, which is the first protein-based vaccine offered to Americans. This followed our emergency use authorization and unanimous recommendation from the FDA's Advisory Committee, VRBPAC and the CDC's Advisory Committee on immunization practices.

從運營的角度來看，我們再次經歷了歷史上最俱生產力和變革性的時期之一——變革性的季度。在美國，目前正在使用我們的 COVID-19 疫苗進行免疫接種，這是向美國人提供的第一種基於蛋白質的疫苗。這遵循了我們的緊急使用授權和 FDA 諮詢委員會、VRBPAC 和 CDC 免疫實踐諮詢委員會的一致建議。

Globally, we continued the rollout of our COVID-19 vaccine. We have authorization in 43 countries. And as of today, we have delivered over 73 million doses around the world. We initiated new studies in adolescents in younger children, and we made progress in expanding our label. We have already received authorizations for boosting in adolescents in markets around the world with more to come.

在全球範圍內，我們繼續推出 COVID-19 疫苗。我們在 43 個國家獲得授權。截至今天，我們已在全球範圍內交付了超過 7300 萬劑疫苗。我們在年幼兒童的青少年中開展了新的研究，並在擴大我們的標籤方面取得了進展。我們已經獲得了在全球市場促進青少年發展的授權，未來還會有更多。

And this past quarter, we announced new data for our prototype vaccines, showing that immune responses to our vaccines have proven to give broad protection against barriers, which we think is a unique feature of our recombinant nanoparticle adjuvanted vaccine. We also showed data on our vaccines durability and breadth of response through 12 months. At the same time, we know the market is quickly evolving. And during the quarter, we advanced our Omicron strain vaccine program.

在上個季度，我們公佈了原型疫苗的新數據，表明對我們疫苗的免疫反應已被證明可以提供廣泛的屏障保護，我們認為這是我們的重組納米顆粒佐劑疫苗的獨特特徵。我們還展示了我們的疫苗在 12 個月內的持久性和反應廣度的數據。同時，我們知道市場正在迅速發展。在本季度，我們推進了 Omicron 毒株疫苗計劃。

I will say 9it one more time, this is a transformational year for the company, and we're building on a great vaccine platform. And having said that, we are in a very dynamic environment. We have all the opportunities of having a great product gives us. But as I've already said, we also have a number of uncertainties that we are constantly managing. It's important to note that while some of our delivery schedules have been shifted into 2023, total demand under most APAs remains unchanged.

我再說一次 9it，這對公司來說是轉型的一年，我們正在建立一個偉大的疫苗平台。話雖如此，我們處於一個非常動態的環境中。我們擁有擁有出色產品的所有機會。但正如我已經說過的，我們也有一些我們一直在管理的不確定性。需要注意的是，雖然我們的一些交付時間表已移至 2023 年，但大多數 APA 下的總需求保持不變。

With all this in mind today, we are revising our 2022 full year revenue guidance to $2 billion to $2.3 billion, and we'll talk more about this during our call today. Through our commercial readiness efforts and global label expansion to date, we believe we are laying the foundation for a successful transition to a commercial market in 2023 and are poised to play a significant role in the future COVID-19 landscape.

考慮到今天這一切，我們將 2022 年全年收入指引修訂為 20 億至 23 億美元，我們將在今天的電話會議中更多地討論這個問題。通過我們迄今為止的商業準備工作和全球標籤擴張，我們相信我們正在為 2023 年成功過渡到商業市場奠定基礎，並準備在未來的 COVID-19 格局中發揮重要作用。

With that, I'd now like to hand it over to Filip.

有了這個，我現在想把它交給菲利普。

Thanks, Stan. Please skip Slide 6 and jump to Slide 7. Our clinical development program is collecting data to expand our label for additional indications and populations. Today, I'll discuss clinical updates for 3 key areas: homologous and heterologous boosting, expansion into younger pediatric populations and the development of our Omicron variant vaccine.

謝謝，斯坦。請跳過幻燈片 6 並跳至幻燈片 7。我們的臨床開發計劃正在收集數據以擴展我們的標籤以適應其他適應症和人群。今天，我將討論 3 個關鍵領域的臨床更新：同源和異源加強免疫、擴展到更年輕的兒科人群以及我們的 Omicron 變異疫苗的開發。

Okay. Let's go to Slide 8 and 9, please. This is data recently made available by the U.S. government and NIH scientists, identifying a coat of protection for our vaccine. This coat of core protection was identified in our U.S. Mexico Phase III study, where a majority of the cases were caused by variants. The study concludes that while both pseudoneutralization and IgG can serve as coat of protection, the IgG seems to better predict protective responses. On the bottom of the slide are the antibody levels associated with various levels of protection. This study confirms that IgG is critical to understand the protective efficacy of our vaccines.

好的。請看幻燈片 8 和 9。這是美國政府和 NIH 科學家最近提供的數據，為我們的疫苗確定了一層保護層。我們在美國墨西哥的 III 期研究中發現了這種核心保護層，其中大多數病例是由變異引起的。該研究得出結論，雖然假中和和 IgG 都可以作為保護層，但 IgG 似乎可以更好地預測保護性反應。幻燈片底部是與各種保護級別相關的抗體水平。這項研究證實，IgG 對於了解我們疫苗的保護功效至關重要。

Now let's move to Slide 10, please. What's displayed here is the immune response kinetics from our U.S., Australia study after 2-dose priming series have boosted 6 months and another boost at 12 months. You can see a peak following 2 doses, which decays over 6 months; is booted with a single dose followed by a slower decay over the subsequent 6 months; and finally, a very good boost with the fourth dose.

現在讓我們轉到幻燈片 10。這裡顯示的是我們在美國、澳大利亞研究中的免疫反應動力學，該研究在 2 劑初免系列提高了 6 個月並在 12 個月後再次加強。您可以在 2 次劑量後看到一個峰值，該峰值會在 6 個月內衰減；以單劑量啟動，隨後在隨後的 6 個月內緩慢衰減；最後，第四劑的效果非常好。

Okay. Give me a click. Here, I've highlighted the antibody levels after the 6-month boosts are completely remain over the level associated with protection in our Phase III study. This gives us confidence we maintain protective immune responses over time.

好的。給我一個點擊。在這裡，我強調了 6 個月加強後的抗體水平完全保持在我們 III 期研究中與保護相關的水平之上。這讓我們有信心隨著時間的推移保持保護性免疫反應。

Okay. Let's go Slide 11, please. Explained here is antibody kinetics from our U.S. Mexico Phase III study. You can see a peak after 2 doses, which the case through month 11 with a high boost, with a single dose achieving a 27-fold increase from the pre-boost levels.

好的。請讓我們看幻燈片 11。這裡解釋的是來自我們美國墨西哥 III 期研究的抗體動力學。您可以在 2 次劑量後看到一個峰值，在第 11 個月的情況下，這種情況具有很高的加強，單次劑量比加強前的水平增加了 27 倍。

Okay, give me a click. And here, what we've done is overlay the protective thresholds derived from the U.S. government scientists over our vaccine response. You can see that 7 months, this data predicts approximately 88% efficacy. And importantly, after the boost, high immune responses are achieved that are associated with more than 95% protection.

好的，給我點一下。在這裡，我們所做的是將來自美國政府科學家的保護閾值覆蓋在我們的疫苗反應之上。你可以看到7個月，這個數據預測了大約88%的療效。重要的是，在加強免疫後，可實現高免疫反應，並提供超過 95% 的保護。

Okay, let's go to Slide 12. Here, we've displayed the immune responses of our prototype vaccine -- what our prototype vaccine induces against Omicron-BA.1 subvariant using our validated assay. You see a very similar pattern to what you saw in the previous slide. And importantly, after boosting at 11 months, the antiviral levels are comparable to the prototype responses we saw in the previous slide.

好的，讓我們轉到幻燈片 12。在這裡，我們展示了我們的原型疫苗的免疫反應——我們的原型疫苗使用我們經過驗證的試驗對 Omicron-BA.1 亞變體誘導了什麼。您會看到與在上一張幻燈片中看到的非常相似的模式。重要的是，在 11 個月加強後，抗病毒水平與我們在上一張幻燈片中看到的原型反應相當。

Okay, give me a build. And once again, we've applied the government coat of protection thresholds. You can see that significant protection can be expected after 2 doses, and a 95 protective level is predicted after boosting dose that was delivered at 11 months. I remind you that the model was developed from our data in the Phase III study, in which the majority of cases were caused by various suggesting relevance for this analysis.

好吧，給我一個構建。再一次，我們已經應用了政府的保護門檻。您可以看到在 2 次劑量後可以預期得到顯著的保護，並且在 11 個月時給予加強劑量後預測為 95 的保護水平。我提醒您，該模型是根據我們在 III 期研究中的數據開發的，其中大多數案例是由與該分析的各種暗示相關性引起的。

Okay. Let's go to Slide 13. Here on the left side are the immune responses after 2 doses against prototype BA.1, BA.2 and BA.5. You can see that 100% of participants seroconverted after 2 doses. On the right-hand side, we display their responses after 3 doses. After boosting for all the variants, you can see we've achieved the levels comparable to those seen in the Phase III study that was associated with over 90% protection.

好的。讓我們轉到幻燈片 13。左側是 2 劑後針對原型 BA.1、BA.2 和 BA.5 的免疫反應。您可以看到 2 劑後 100% 的參與者發生了血清轉化。在右側，我們顯示了他們在 3 次給藥後的反應。在對所有變體進行增強後，您可以看到我們已經達到了與 III 期研究中所見的水平相當的水平，該研究與超過 90% 的保護相關。

Okay. Let's go to Slide 14. And here, we see data in a multidimensional presentation of the immune responses from our U.S. Mexico Phase III study called antigenic cartography. This method displays the building of the vaccine-induced antibody to recognize variant spike proteins. The prototype is indicated in dark blue. And the closer to the variants appear to the dark blue circle, the better the immune responses recognize the variants. Each square in the grid represents a twofold difference in antibody levels. Thus, 2 squares represents a fourfold difference.

好的。讓我們轉到幻燈片 14。在這裡，我們看到了來自美國墨西哥 III 期研究（稱為抗原製圖）的免疫反應的多維呈現數據。該方法展示了構建疫苗誘導的抗體以識別變異刺突蛋白。原型以深藍色表示。並且越接近變體出現在深藍色圓圈中，免疫反應就越能識別變體。網格中的每個正方形代表抗體水平的兩倍差異。因此，2 個方格代表四倍的差異。

On the left-hand side, we show antibody binding after 2 doses in the priming series. While there was a 100% seroconversion to all Omicron subvariants after 2 doses, the energy distance between the matched prototype strain and Omicron subvariants range from 7.9 to 11.8-fold different.

在左側，我們顯示了啟動系列中 2 劑後的抗體結合。雖然在 2 次給藥後對所有 Omicron 子變體有 100% 的血清轉化，但匹配的原型菌株和 Omicron 子變體之間的能量距離相差 7.9 到 11.8 倍。

On the right-hand side, after single dose, antigenic distance decreases for all of the Omicron variants, with BA.5 decreasing to just 2.9-fold difference, which could be considered a mass response in the influenza language.

在右側，單次給藥後，所有 Omicron 變體的抗原距離都減小了，BA.5 減少到僅 2.9 倍的差異，這可以被認為是流感語言中的大規模反應。

This analysis leads us to believe that as we immunize with additional doses of our recombinant spike protein vaccine, we minimize annotate distance and begin to observe a more universal like response against variants.

該分析使我們相信，當我們用額外劑量的重組刺突蛋白疫苗進行免疫時，我們將註釋距離最小化並開始觀察到針對變體的更普遍的類似反應。

Okay, let's turn to Slide 15 for a quick summary. Clearly, we do not know what will emerge after BA.5, so forward DRIP will be a key issue to be addressed for all COVID vaccines. But boosting with our technology may be an attractive option as it provides both high levels of antibodies recognizing variants in a durable immune response. Although it's not certain a very specific vaccine will provide significant clinical benefit, we are evaluating a number of constructs in clinical studies, and I'll describe those studies in a couple of slides.

好的，讓我們轉到幻燈片 15 進行快速總結。顯然，我們不知道 BA.5 之後會出現什麼，因此前向 DRIP 將是所有 COVID 疫苗需要解決的關鍵問題。但是，利用我們的技術增強可能是一個有吸引力的選擇，因為它提供了高水平的抗體，可識別持久免疫反應中的變體。雖然不確定一種非常具體的疫苗是否會提供顯著的臨床益處，但我們正在評估臨床研究中的一些結構，我將在幾張幻燈片中描述這些研究。

But first, let's move through Slide 16 to Slide 17 and talk about our pediatric development. This is the ongoing placebo-controlled HD escalation study that's evaluating the safety hemologic effectiveness and clinical efficacy in children 6 months to 11 years of age. We will evaluate our standard 2-dose schedule with a 6-month boost. The study has 3 age bands at 6 to 11, 2 to 5 and 6 months to 23 months, and the vaccine will be evaluated in a stepwise approach.

但首先，讓我們從幻燈片 16 轉到幻燈片 17，然後談談我們的兒科發展。這是正在進行的安慰劑對照 HD 升級研究，旨在評估 6 個月至 11 歲兒童的安全性血液學有效性和臨床療效。我們將評估我們的標準 2 劑計劃，增加 6 個月。該研究有 6 至 11、2 至 5 和 6 至 23 個月的 3 個年齡段，疫苗將分步進行評估。

(inaudible) cohort in 6- to 11-year-olds has already been enrolled. And after the safety is reviewed, vaccination will continue. The study is ongoing in the U.S., and we plan to expand the study to the countries indicated on the slide.

（聽不清）6 至 11 歲的隊列已經被招募。並且在審查了安全性之後，疫苗接種將繼續進行。該研究正在美國進行，我們計劃將研究擴展到幻燈片上所示的國家/地區。

So let's go to Slide 19, my last slide. And this is the ongoing study that will compare the performance of our prototype vaccine to a BA.1 variant vaccine and a BA.5 variant vaccine adults, who have received 2 or more previous doses of mRNA vaccine. Group 1 has been enrolled and will compare our prototype vaccine to a BA.1 vaccine as well as BA.1-plus prototype format. We expect top line results towards the end of the third quarter and to initiate Group 2 in the fourth quarter.

讓我們轉到幻燈片 19，我的最後一張幻燈片。這是正在進行的研究，將我們的原型疫苗的性能與 BA.1 變體疫苗和 BA.5 變體疫苗成人進行比較，他們之前已經接受過 2 劑或更多劑 mRNA 疫苗。第 1 組已註冊並將我們的原型疫苗與 BA.1 疫苗以及 BA.1-plus 原型形式進行比較。我們預計將在第三季度末取得最高業績，並在第四季度啟動第 2 組。

In this study, we will compare the variant-specific immune responses among the trial arms to support a data-driven decision about the utility of variant vaccines as it applies to our adjuvanted recombinant protein technology. If it continues to be deemed desirable, our goal is to have variant vaccines ready for regulatory evaluation in the fourth quarter.

在這項研究中，我們將比較試驗組之間的變異特異性免疫反應，以支持關於變異疫苗效用的數據驅動決策，因為它適用於我們的佐劑重組蛋白技術。如果它繼續被認為是可取的，我們的目標是在第四季度準備好變異疫苗進行監管評估。

Okay. Let me hand it over to John for the commercial perspective.

好的。讓我把它交給 John 從商業角度來看。

Thanks, Filip. Now let's discuss the status of our commercial rollout globally.

謝謝，菲利普。現在讓我們討論一下我們在全球範圍內商業推廣的狀態。

Turning to the rollout, what I'd like to do is go to Slide 21. Since the start of our commercial launch to date, we and our partners have delivered over 73 million doses of Nuvaxovid and Covovax around the world. As Stan mentioned, this includes over 23 million doses delivered since the start of the third quarter, including 3.2 million doses delivered in the United States. We are pleased to report that our vaccine is now available in 47 states across the U.S., and vaccinations are underway.

關於推出，我想做的是轉到幻燈片 21。自我們開始商業發布至今，我們和我們的合作夥伴已經在全球交付了超過 7300 萬劑 Nuvaxovid 和 Covovax。正如斯坦所說，這包括自第三季度開始以來交付的超過 2300 萬劑，其中包括在美國交付的 320 萬劑。我們很高興地報告，我們的疫苗現已在美國 47 個州上市，疫苗接種工作正在進行中。

Our over 73 million doses delivered to date include deliveries by our partners into the licensed territories. Serum Institute of India, SK Bioscience and Takeda have all successfully delivered over 17 million doses to licensed territories since the start of our commercial launch, including in Japan, South Korea, India, Indonesia and Thailand.

迄今為止，我們已交付超過 7300 萬劑疫苗，其中包括我們的合作夥伴向許可地區交付的疫苗。自我們的商業啟動開始以來，印度血清研究所、SK Bioscience 和武田已成功向許可地區交付了超過 1700 萬劑，包括日本、韓國、印度、印度尼西亞和泰國。

Receiving booster and adolescent label expansions globally has taken longer than expected, and expanding our label is our core commercial priority. When coupled with global oversupply, this drove a shift in demand for our vaccine from the second quarter into the second half of the year and into 2023. It is important to note that our total contracted demand remains mostly unchanged, although after ongoing discussions with Gavi, we no longer expect to receive an order from the COVAX facility in 2022.

在全球範圍內接收助推器和青少年標籤擴展所花費的時間比預期的要長，擴展我們的標籤是我們的核心商業優先事項。再加上全球供過於求，這推動了對我們疫苗的需求從第二季度到今年下半年以及到 2023 年的轉變。重要的是要注意，我們的總合同需求基本保持不變，儘管在與 Gavi 的持續討論之後，我們不再期望在 2022 年收到來自 COVAX 工廠的訂單。

In the U.K., we recently amended our supply agreement, which now includes the purchase of a minimum of 1 million doses and up to an additional 15 million doses, contingent upon receiving supportive policy recommendations from the U.K.'s policymaking body, JCVI. The agreement also includes an option to purchase up to an additional 44 million doses through 2024. And for Europe, we expect to deliver the remainder of our total order, which is currently 65 million doses from a previous 70 million doses in the second half of this year and into 2023.

在英國，我們最近修改了我們的供應協議，現在包括購買至少 100 萬劑和最多額外 1500 萬劑，這取決於收到英國決策機構 JCVI 的支持性政策建議。該協議還包括到 2024 年再購買多達 4400 萬劑的選項。對於歐洲，我們預計將交付我們總訂單的剩餘部分，目前是 6500 萬劑，而之前的 7000 萬劑將在下半年交付。今年到2023年。

Next, label expansion. Please turn to Slide 22. For boosting to date, we've received authorizations in Australia for homologous and heterologous boosting authorization in New Zealand and approval in Japan in partnership with Takeda. Additionally, over a dozen policymaking bodies have issued guidance allowing for the use of Nuvaxovid as a homologous and heterologous booster dose in adults, including Australia, Canada, Germany, South Korea and other markets. For boosting, we've also completed additional submissions for authorization for boosting in the EU, Great Britain and Switzerland and will submit in the U.S. by the end of this month.

接下來，標籤擴展。請轉到幻燈片 22。迄今為止，我們已在澳大利亞獲得授權，在新西蘭獲得同源和異源助推授權，並與武田合作在日本獲得批准。此外，十多個政策制定機構已發布指南，允許在包括澳大利亞、加拿大、德國、韓國和其他市場的成人中使用 Nuvaxovid 作為同源和異源加強劑量。對於 boosting，我們還在歐盟、英國和瑞士完成了額外的 boosting 授權申請，並將於本月底在美國提交。

For pediatric and adolescent label expansion, today, we are expanding our label into adolescents ages 12 to 17, and we've already begun clinical development in pediatrics ages 6 months to 11 years of age to support additional expansions to our label in the months to come. For adolescents, we received authorizations to date in the EU, Australia, India and Thailand in partnership with Serum Institute and in Japan in partnership with Takeda. Importantly, following the European Commission's adolescent authorization, at least 2 NITAGs in the EU have issued recommendations permitting use of Nuvaxovid as a third dose and/or as a heterologous booster in adolescents 12 to 17. We've also completed adolescent submissions in the U.S., Great Brain, Canada, Switzerland and New Zealand, Taiwan and the World Health Organization.

對於兒科和青少年標籤擴展，今天，我們正在將我們的標籤擴展到 12 至 17 歲的青少年，我們已經開始在 6 個月至 11 歲的兒科中進行臨床開發，以支持在幾個月內對我們的標籤進行額外擴展來。對於青少年，迄今為止，我們與 Serum Institute 合作在歐盟、澳大利亞、印度和泰國獲得了授權，並與武田合作在日本獲得了授權。重要的是，根據歐盟委員會的青少年授權，歐盟至少有 2 個 NITAG 已發佈建議，允許在 12 至 17 歲的青少年中使用 Nuvaxovid 作為第三劑和/或異源增強劑。我們還在美國完成了青少年提交。 ，大腦，加拿大，瑞士和新西蘭，台灣和世界衛生組織。

As I mentioned, beyond adolescents, we also leveraged data from our recently initiated Phase IIb/III global clinical trial to pursue label expansion in younger children 6 months of age to 11 years -- 6 months to 11 years of age, positioning us to capture significant market share in 2023.

正如我所提到的，除了青少年之外，我們還利用我們最近啟動的 IIb/III 期全球臨床試驗的數據，在 6 個月至 11 歲（6 個月至 11 歲）的幼兒中進行標籤擴展，使我們能夠捕捉到2023 年的重要市場份額。

Now please turn to Slide 23. As we continue to supply our vaccine globally, we remain confident in our competitive product profile, including our vaccine's efficacy, well-tolerated safety profile, durability of protection and ability to address both current and future variant strains. Recognizing our vaccines utility in the ongoing fight against COVID-19, our commercial efforts are also focused on driving uptake of our prototype vaccine. To that end, we've deployed branded and unbranded advertising campaigns in various markets to build awareness and promote broad market access.

現在請轉到幻燈片 23。隨著我們繼續在全球範圍內供應我們的疫苗，我們對我們具有競爭力的產品概況仍然充滿信心，包括我們疫苗的功效、耐受性良好的安全概況、保護的持久性以及應對當前和未來變異株的能力。認識到我們的疫苗在與 COVID-19 的持續鬥爭中的效用，我們的商業努力也集中在推動我們的原型疫苗的採用。為此，我們在各個市場部署了品牌和非品牌廣告活動，以建立知名度並促進廣泛的市場准入。

And finally, we are broadening our global commercial footprint and have established additional offices to execute locally in key markets around the world including our new European regional office in Switzerland and expansion into Asia Pacific currently underway in Australia and Singapore. Looking ahead, we expect to see a transition from the pandemic phase to a more traditional commercial market in 2023 in the U.S. and other key high-income country markets.

最後，我們正在擴大我們的全球商業版圖，並在全球主要市場建立了額外的辦事處，以在當地開展業務，包括我們在瑞士的新歐洲區域辦事處，以及目前正在澳大利亞和新加坡向亞太地區的擴張。展望未來，我們預計 2023 年美國和其他主要高收入國家市場將從大流行階段過渡到更傳統的商業市場。

Now moving on to manufacturing. Regarding manufacturing over the past 2 years, we have rapidly built a global manufacturing and supply infrastructure to produce both antigen and adjuvant. Today, we are collaborating with our core partners, and we are manufacturing at a consistent run rate that enables us to produce sufficient supply to meet global customer demand. Our partner, Serum, successfully passed -- surpassed multiple regulatory inspections in the quarter and is our primary manufacturing partner for most of our global supply.

現在轉向製造。在過去兩年的製造方面，我們迅速建立了全球製造和供應基礎設施，以生產抗原和佐劑。今天，我們正在與我們的核心合作夥伴合作，我們以一致的運行速度進行製造，使我們能夠生產足夠的供應來滿足全球客戶的需求。我們的合作夥伴 Serum 在本季度成功通過了多項監管檢查，是我們大部分全球供應的主要製造合作夥伴。

Our recent progress includes the addition of SK Bioscience to our EU manufacturing network and an expanded agreement with SK Bioscience to support overcrowd manufacturing. SK Bioscience will also manufacture our vaccine in prefilled syringes in addition to Serum Institute in 2023, therefore, providing widespread availability of a preformulated single-dose prefilled syringe while maintaining 2 to 8 C refrigerated stability and an expectation of up to 12 months of dating.

我們最近取得的進展包括將 SK Bioscience 添加到我們的歐盟製造網絡，以及與 SK Bioscience 簽署擴大協議以支持過度擁擠的製造。除了 Serum Institute 之外，SK Bioscience 還將在 2023 年在預裝注射器中生產我們的疫苗，因此，提供預配製單劑量預裝注射器的廣泛可用性，同時保持 2 至 8 C 的冷藏穩定性和長達 12 個月的約會預期。

Additionally, we continue to make progress to bring our Novavax CZ facility in the Czech Republic online. We remain on track to add Novavax CZ as a manufacturing node for our European supply, and we now expect to submit to EMA in the third quarter. The combination of Serum Institute, SK Bio and our CZ facility provides for a robust manufacturing infrastructure for supply of COVID vaccine and others into the foreseeable future. We expect that in 2023, with indications achieved for boosting adolescents, children 6 months of age and older, a bivalent and/or monovalent variant vaccine option and our strong global manufacturing network, we will be poised for success in a commercial market.

此外，我們繼續取得進展，使我們在捷克共和國的 Novavax CZ 設施上線。我們仍有望將 Novavax CZ 添加為我們歐洲供應的製造節點，我們現在預計將在第三季度提交給 EMA。 Serum Institute、SK Bio 和我們的 CZ 設施的結合為在可預見的未來供應 COVID 疫苗和其他疫苗提供了強大的製造基礎設施。我們預計，到 2023 年，隨著增強青少年、6 個月及以上兒童的適應症、二價和/或單價變異疫苗選擇以及我們強大的全球製造網絡，我們將在商業市場上取得成功。

With that, I'd now like to turn it over to Jim to discuss our financial results.

有了這個，我現在想把它交給吉姆來討論我們的財務業績。

Thank you, John. Please turn to Slides 24 and 25. I'll begin by providing an overview of our second quarter 2022 total revenue performance, net income and cash position. Then I'll discuss our quarterly results in additional detail and provide commentary on our revised full year 2022 revenue guidance.

謝謝你，約翰。請轉到幻燈片 24 和 25。我將首先概述我們 2022 年第二季度的總收入表現、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，並就我們修訂後的 2022 年全年收入指引發表評論。

In the second quarter of 2022, we recorded $186 million in total revenue, a net loss of $510 million, and we ended the period with $1.4 billion in cash.

在 2022 年第二季度，我們的總收入為 1.86 億美元，淨虧損 5.1 億美元，我們以 14 億美元的現金結束了這一時期。

Please turn to Slide 26, where I'll provide a comprehensive overview of our second quarter results. For the second quarter of 2022, we recorded total revenue of $186 million compared to $298 million in the second quarter of 2021. Total revenue for the second quarter included $55 million in product sales based on 3 million doses sold by Novavax; $23 million of royalties and other revenue, including the recognition of a $20 million milestone payment from Takeda related to our first commercial sale in Japan; and $108 million in grants revenue from the U.S. government.

請轉到幻燈片 26，我將在其中全面概述我們第二季度的業績。 2022 年第二季度，我們的總收入為 1.86 億美元，而 2021 年第二季度為 2.98 億美元。第二季度的總收入包括基於 Novavax 銷售的 300 萬劑的產品銷售額 5500 萬美元； 2300 萬美元的特許權使用費和其他收入，包括確認武田與我們在日本的首次商業銷售相關的 2000 萬美元里程碑付款；以及來自美國政府的 1.08 億美元贈款收入。

Branch revenue for the second quarter of 2022 was lower as expected, given the decrease in activities under our agreements with the U.S. government and completion of the CEPI-related activities in 2021. We entered 2022 with approximately $800 million of funding remaining under our $1.8 billion in U.S. government agreements and expect to record at least $400 million of this amount during 2022, with the remainder in 2023.

鑑於我們與美國政府的協議項下的活動減少以及 CEPI 相關活動於 2021 年完成，2022 年第二季度的分支機構收入低於預期。進入 2022 年，我們的 18 億美元資金仍有約 8 億美元在美國政府協議中，預計 2022 年將記錄至少 4 億美元，其餘在 2023 年。

Our cost of sales for the second quarter of 2022 was $271 million. I'll discuss this in a bit more detail on the next slide.

我們 2022 年第二季度的銷售成本為 2.71 億美元。我將在下一張幻燈片中更詳細地討論這一點。

R&D expenses for the second quarter of 2022 were $290 million compared to $571 million for the comparable period in 2021. The decrease in the current quarter was primarily the result of lower clinical development activities for our COVID-19 vaccine, the capitalization of manufacturing costs and a net benefit from previously recognized embedded lease costs for manufacturing supply agreements. We expect our full year 2022 R&D expenses to be lower than 2021.

2022 年第二季度的研發費用為 2.9 億美元，而 2021 年可比期間為 5.71 億美元。本季度的減少主要是由於我們 COVID-19 疫苗的臨床開發活動減少、製造成本資本化和先前確認的製造供應協議嵌入租賃成本的淨收益。我們預計我們 2022 年全年的研發費用將低於 2021 年。

Additionally, we recorded selling, general and administrative expenses of $108 million for the second quarter of 2022 compared to $73 million in the second quarter of 2021. The increase quarter-over-quarter was a result of commercial launch costs associated with our COVID-19 vaccine. We expect our full year 2022 SG&A costs to increase compared to 2021 as we continue to enhance our commercial capabilities for our COVID-19 vaccine. For the second quarter of 2022, we recorded a net loss of $510 million compared to a net loss of $352 million in the second quarter of 2021.

此外，我們在 2022 年第二季度記錄了 1.08 億美元的銷售、一般和管理費用，而 2021 年第二季度為 7300 萬美元。環比增長是由於與我們的 COVID-19 相關的商業啟動成本疫苗。隨著我們繼續增強 COVID-19 疫苗的商業能力，我們預計 2022 年全年的 SG&A 成本將比 2021 年增加。 2022 年第二季度，我們錄得 5.1 億美元的淨虧損，而 2021 年第二季度的淨虧損為 3.52 億美元。

And finally, we continue to maintain a full tax valuation allowance, and we ended the second quarter of 2022 with $1.4 billion in cash.

最後，我們繼續保持全額稅收減免，我們在 2022 年第二季度結束時擁有 14 億美元的現金。

Please turn to Slide 27, where I'll discuss our cost of sales in more detail. Cost of sales for the second quarter of 2022 were $271 million, and this includes $255 million related to excess, obsolete or expired inventory and losses on firm purchase commitments under our third-party supply agreements. The recognition of these costs were driven by a substantial reduction of our expected deliveries to COVAX and a deferral of deliveries to other customers.

請轉到幻燈片 27，我將在其中更詳細地討論我們的銷售成本。 2022 年第二季度的銷售成本為 2.71 億美元，其中包括 2.55 億美元與過剩、過時或過期的庫存以及根據我們的第三方供應協議確定的採購承諾相關的損失。這些成本的確認是由於我們對 COVAX 的預期交付量大幅減少以及向其他客戶交付的延遲。

As a reminder, during 2021 and prior to regulatory authorizations for our COVID-19 vaccine, certain manufacturing costs were expensed to research and development that would otherwise have been capitalized inventory. If not for the reduced cost of inventory for the period, full cost of sales for the second quarter would have been approximately $280 million. We expect to utilize the majority of our reduced cost inventory during 2022. Based on our standard costs, our COVID-19 vaccine gross margins on sales to high-income countries are expected to be between 70% and 85% of product sales.

提醒一下，在 2021 年期間以及在我們的 COVID-19 疫苗獲得監管授權之前，某些製造成本被用於研發，否則這些成本將被資本化。如果不是因為該期間庫存成本的降低，第二季度的全部銷售成本將約為 2.8 億美元。我們預計將在 2022 年利用我們降低成本的大部分庫存。根據我們的標準成本，我們向高收入國家銷售的 COVID-19 疫苗毛利率預計將在產品銷售額的 70% 至 85% 之間。

Please turn to Slide 28, where we'll provide an overview of our financial guidance for 2022. As stated earlier, we are revising our full year 2022 total revenue guidance to $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. Our revised guidance takes into account both the demand and market supply dynamics discussed on the call today. We look forward to sharing additional updates as we progress in coming quarters.

請轉到幻燈片 28，我們將在其中概述我們對 2022 年的財務指導。如前所述，我們正在將 2022 年全年總收入指導修改為 20 億美元至 23 億美元。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。我們修訂後的指導考慮了今天電話會議上討論的需求和市場供應動態。隨著我們在未來幾個季度的進展，我們期待分享更多更新。

With that, I'd like to turn it over to Stan to discuss our upcoming strategic priorities.

有了這個，我想把它交給斯坦來討論我們即將到來的戰略重點。

Thank you, Jim. In the coming months, we will remain focused on achieving our key strategic priorities for 2022 that include continuing delivery of our vaccine globally; maximizing our label with the addition of boosting in adolescent populations, this is critical to access global demand; completing development of our Omicron-containing vaccine and pilot in the fourth quarter; and progressing into Phase II for our COVID-19 influenza combination vaccine, all to enable initiation of our Phase III study in 2023.

謝謝你，吉姆。在接下來的幾個月裡，我們將繼續專注於實現 2022 年的關鍵戰略重點，包括繼續在全球範圍內提供我們的疫苗；通過增加青少年人口來最大化我們的標籤，這對於獲得全球需求至關重要；在第四季度完成我們的含 Omicron 疫苗和試點的開發；我們的 COVID-19 流感聯合疫苗進入 II 期，所有這些都是為了能夠在 2023 年啟動我們的 III 期研究。

I believe that, over time, we're going to show that our vaccine will demonstrate longer-lasting protection than other platforms that will show that, used as a booster, our vaccine can protect against a broader range of virus variants. It will be easier to use, and it will be amenable to combinations of respiratory viruses, including influenza. If I'm right, these attributes should translate in the long term to our ability to build a significant share of the recurring COVID market.

我相信，隨著時間的推移，我們將證明我們的疫苗將展示出比其他平台更持久的保護作用，其他平台將表明，作為助推器，我們的疫苗可以抵禦更廣泛的病毒變體。它將更易於使用，並且可以適應包括流感在內的呼吸道病毒的組合。如果我是對的，從長遠來看，這些屬性應該轉化為我們在經常性 COVID 市場中建立重要份額的能力。

Thank you for your attention. I'll now turn it over to the operator for Q&A.

感謝您的關注。我現在將其交給接線員進行問答。

(Operator Instructions) Our first question comes from Georgi Yordanov with Cowen and Co.

（操作員說明）我們的第一個問題來自 Cowen and Co. 的 Georgi Yordanov。

Maybe, first, can you just help us understand exactly how the contract with the EU or -- you had previously said that there were 27 million doses that were scheduled to be delivered in Q1 then 42 million doses for Q2. Does that the current revenue looks like? Basically, you failed to deliver those doses. Like can you just explain like how exactly we should expect the revenue to be flowing and why were only [3 million] doses delivered this quarter? And then I have a couple of follow-ups.

也許，首先，您能否幫助我們準確了解與歐盟簽訂的合同，或者 - 您之前曾說過計劃在第一季度交付 2700 萬劑疫苗，然後在第二季度交付 4200 萬劑疫苗。目前的收入是這樣的嗎？基本上，你沒有提供這些劑量。就像你能解釋一下我們應該如何預計收入將流動以及為什麼本季度只交付了 [300 萬劑] 劑？然後我有幾個跟進。

Yes. So this is Stan. So actually, we delivered the doses in the first quarter and then we delivered the doses in the second quarter. All those doses were actually in our warehouse, our distribution center in Europe. And the problem was -- is we had a -- it took longer to get through all of the internal -- what I mean internal, I mean in-country processes that get the vaccine released and to the customer on time so that we could book it in -- by June 30. And unfortunately, June 30 is a non-movable master, and we missed by a few weeks. And so we had actually all those doses got invoiced in July. As I mentioned, we have, I think, since July 1, over $400 million worth of revenue just in that period alone, that belong in the second quarter, but we missed June 30.

是的。這就是斯坦。所以實際上，我們在第一季度交付了劑量，然後在第二季度交付了劑量。所有這些劑量實際上都在我們的倉庫裡，我們在歐洲的配送中心。問題是——我們是否有一個——通過所有內部——我的意思是內部的，我的意思是在國內的流程，讓疫苗按時發布並交付給客戶，這樣我們就可以在 6 月 30 日之前預訂它。不幸的是，6 月 30 日是一個不可移動的大師，我們錯過了幾個星期。所以我們實際上所有這些劑量都在 7 月份開具了發票。正如我所提到的，我認為，自 7 月 1 日以來，僅在那個時期，我們就有超過 4 億美元的收入屬於第二季度，但我們錯過了 6 月 30 日。

So do we expect some -- I guess, for Q2, the [regional] agreement was for 42 million doses? Do you expect to realize or, I guess, invoice all of those 42 million doses in Q3 with the exception for the Q2 revenue?

那麼我們是否期待一些——我猜，對於第二季度，[區域]協議是針對 4200 萬劑的？除了第二季度的收入外，您是否希望在第三季度實現所有 4200 萬劑疫苗，或者我猜是開具發票？

So I think as John mentioned, all of these -- so these orders, all the customers want to look and see whether they can get a delivery in the second quarter versus they're now moving to third or second or fourth. And we're trying to accommodate all of the customers request by moving doses around. So it's a bit of a moving target. We don't see -- right now, we don't see reducing their orders. What we see is them reduce -- what we see is spreading it out over an extra quarter or 2. And so that's what we look at right now. And so it's hard to say what's really going to happen there because it's hard to say what the surge in the fourth quarter is going to -- will do to those orders and what the use of our vaccine as a booster will do and how quickly that will take our product. So it's -- but we -- so it's moved, but we haven't lost orders yet.

所以我認為正如約翰所提到的，所有這些 - 所以這些訂單，所有客戶都想看看他們是否可以在第二季度收到交貨，而不是他們現在正在移動到第三或第二或第四。我們正試圖通過移動劑量來滿足所有客戶的要求。所以這是一個移動的目標。我們沒有看到——現在，我們沒有看到減少他們的訂單。我們看到的是它們減少了——我們看到的是把它分散到一個額外的四分之一或兩個季度。這就是我們現在所看到的。所以很難說那裡真的會發生什麼，因為很難說第四季度的激增將會對這些訂單產生什麼影響，以及使用我們的疫苗作為助推器會起到什麼作用，以及這種情況的速度有多快將採取我們的產品。所以它 - 但我們 - 所以它被移動了，但我們還沒有失去訂單。

Got it. And then just as a follow-up, I guess, on what you just mentioned, the Q4. Can you talk about -- clearly, most jurisdictions are now expecting an Omicron vaccine in the fall. Can you talk about how do you see that regulatory process? Do you believe that -- you mentioned you don't expect any additional revenue in the U.S. Do you believe that you will be able to actually deliver any Omicron-specific doses this year? And how does the regulatory process then, just given the fact that you're not going to have immunogenicity data in time?

知道了。然後作為後續行動，我想，關於你剛才提到的第四季度。你能談談 - 顯然，大多數司法管轄區現在都期待在秋季推出 Omicron 疫苗。您能談談您如何看待監管過程嗎？您是否相信——您提到您預計美國不會有任何額外收入。您是否相信您今年能夠實際提供任何 Omicron 特定劑量？那麼，鑑於您不會及時獲得免疫原性數據這一事實，監管過程如何？

Yes. Again, this is complicated times. And I think that what we're going to see is we're having, I guess, probably daily discussions about the use of our Wuhan 2373 vaccine, which we have shown today a bit of the data that we've generated, which shows that our vaccine as a booster actually is very effective, similarly neutralizing and protective levels of antibodies against BA.5, BA.4, BA.1. So there's a discussion that we're having as to whether that should be used as a booster, not just in other parts of the world who are also not convinced that maybe having a BA.5 bivalent is the way to go. It's just -- it's not an answered question yet.

是的。同樣，這是一個複雜的時代。而且我認為我們將看到的是，我想，我們可能每天都在討論使用我們的武漢 2373 疫苗，我們今天已經展示了我們生成的一些數據，這表明我們的疫苗作為增強劑實際上非常有效，同樣中和和保護水平的針對 BA.5、BA.4、BA.1 的抗體。因此，我們正在討論是否應該將其用作助推器，而不僅僅是在世界其他地區，他們也不相信也許擁有 BA.5 二價是要走的路。只是——這還不是一個已回答的問題。

And in the U.S., we're having a discussion as to whether we should be shipping -- whether they should be buying our 2373 for boosting in the United States. It's all up in the air. This is August. It's something that one would hope would be solved by now -- resolved by now, but it's not. And so we're in the mix of that discussion. We have good data for 2373. We will have a BA.5 vaccine. But as you pointed out, it will be later in the quarter. And I'm not sure it's needed.

在美國，我們正在討論我們是否應該發貨——他們是否應該購買我們的 2373 以在美國進行提振。一切都懸而未決。這是八月。這是人們希望現在解決的問題——現在解決了，但事實並非如此。所以我們正在討論這個問題。我們有 2373 的良好數據。我們將有 BA.5 疫苗。但正如你所指出的，它將在本季度晚些時候進行。而且我不確定它是否需要。

Got it. So just to confirm, you don't expect that the -- on the Omicron-specific BA.5, you'll be able to deliver that this year.

知道了。因此，只是為了確認一下，您不會期望在 Omicron 特定的 BA.5 上，您將能夠在今年交付它。

No, I didn't say we won't be able to deliver it this year. It just will be later. It's not going to be for October usage.

不，我沒有說我們今年不能交付。只是會晚一點。它不適用於 10 月份的使用。

Next question comes from Roger Song with Jefferies.

下一個問題來自 Jefferies 的 Roger Song。

Great. Maybe just a couple clarification. Can you just provide the granularity for this $2 billion to $2.3 billion updated guidance, specifically how much this U.S. government grant will be included? Because last time, I think where you include $400 million, I see the 1Q and 2Q, each quarter, you delivered -- you recorded $100 million per quarter. Do we still expect another $200 million in the second half?

偉大的。也許只是幾個澄清。您能否提供這個 20 億至 23 億美元的更新指導的粒度，具體來說，這筆美國政府撥款將包括多少？因為上次，我認為你包括 4 億美元，我看到第一季度和第二季度，每個季度，你交付了 - 你每個季度記錄了 1 億美元。我們是否仍然期望下半年再增加 2 億美元？

Also in terms of the product sales, I understand you say you have the EU in Q2 delivery order, maybe the outstanding order of another 5 million doses. But in terms of other countries, what is the breakdown between the product sales versus the other, like loyalty and the government grant?

另外在產品銷售方面，我知道你說你有歐盟的第二季度交貨訂單，也許還有500萬劑的未完成訂單。但就其他國家而言，產品銷售與其他國家之間的細分是什麼，例如忠誠度和政府補助？

Yes. I'll take care of the product sales to the U.S. government in the second half, and that we decided we've sold the government 3.2 million doses that are currently being used. And we decided, without more clarity from the U.S. government, that we're just not going to put in a forecast. And I'm not sure that's my expectation, but that's all we know right now. And so we're being very conservative in that forecast. For the grant related, I think Jim has that number in his mind.

是的。我將在下半年負責向美國政府銷售產品，我們決定向政府出售目前正在使用的 320 萬劑。我們決定，在沒有美國政府更明確的情況下，我們只是不打算進行預測。我不確定這是我的期望，但這就是我們現在所知道的。因此，我們對該預測非常保守。對於與贈款相關的問題，我認為吉姆心中有這個數字。

Yes. So the grant related for the remaining of the year should be just over -- or should be over $200 million. When you look at the midpoint of guidance relative to our sales year-to-date, our year-to-date total revenue of $900 million would leave approximately $1.25 billion at the midpoint. So I just shared that the grant revenue would be over $200 million, and therefore, the remaining billing would go towards EPAs and royalty income.

是的。因此，與今年剩餘時間相關的撥款應該剛剛結束——或者應該超過 2 億美元。當您查看相對於我們年初至今的銷售額的指導中點時，我們年初至今的 9 億美元總收入將在中點留下大約 12.5 億美元。所以我剛剛分享了贈款收入將超過 2 億美元，因此，剩餘的賬單將用於 EPA 和特許權使用費收入。

Got it. Okay. And understanding this demand shift and particularly like for the Omicron-containing vaccine availability, maybe, Stan, if you can share with us the expectation for the 2023 and beyond. Particularly, you mentioned the commercial market in the high-income country, including U.S., EU. And what do you think about the pricing versus the volume or the market share for Novavax against other vaccines?

知道了。好的。如果您能與我們分享對 2023 年及以後的預期，Stan 可能會了解這種需求變化，尤其是對含有 Omicron 的疫苗的可用性。特別是你提到了包括美國、歐盟在內的高收入國家的商業市場。您如何看待 Novavax 相對於其他疫苗的定價與數量或市場份額？

So well, that's a very big question, and I don't think we have a forecast for '23 that we could share. I do think that maybe John can talk about. It will shift into a commercial market at a different price and a lot of different...

好吧，這是一個非常大的問題，我認為我們無法分享 23 年的預測。我確實認為也許約翰可以談談。它將以不同的價格和許多不同的方式進入商業市場……

Yes, I think we're expecting a shift out of the pandemic period into the commercial market in '23, but I think you're going to see that taking place at various times for various countries.

是的，我認為我們預計會在 23 年從大流行時期轉向商業市場，但我認為你會看到不同國家在不同時間發生這種情況。

A couple of things here, and it's all based upon our assessment of where the market is heading, which is a bit of a challenge, as you can imagine. But a couple of fundamental pieces that we're confident about. One is that this virus is not going away. There's going to be a need for at least some annual revaccination. We expect that that's probably going to look like something greater than the existing influenza market. It could be from anywhere from 25% to 50% market size greater than what the current flu market is. We would also reasonably expect that pricing will vary again country by country, but would look a lot like, again, the premium-priced influenza market in the U.S. Proportionately, that will be different in Europe and other countries.

這裡有幾件事，這一切都基於我們對市場走向的評估，正如您可以想像的那樣，這有點挑戰。但是有幾個我們有信心的基本部分。一是這種病毒不會消失。至少需要每年重新接種一次。我們預計這可能看起來比現有的流感市場更大。它的市場規模可能比當前的流感市場大 25% 到 50%。我們還可以合理地預計，各國的定價會再次發生變化，但看起來很像美國的高價流感市場。按比例來說，這在歐洲和其他國家會有所不同。

As we said in the presentation, there are a number of things that have been obstacles for us in '22: booster label, adolescent pediatric label and access into the U.S. market. Therefore, all those obstacles, I think, will be cleared as we head into 2023. And I think as we get through '23 and get the peak non-pandemic, but peak commercial revenue, we should expect to have an expectation in the 20% to 25% market share of that commercial market going forward. Again, all of this is very speculative in nature, but based upon our analysis of the market to date and what we expect the total COVID vaccine marketplace to look like going forward.

正如我們在演示文稿中所說，在 22 年有很多事情一直是我們的障礙：助推器標籤、青少年兒科標籤和進入美國市場。因此，我認為，隨著我們進入 2023 年，所有這些障礙都將被清除。而且我認為，當我們度過 23 年並獲得非大流行病的峰值，但商業收入的峰值時，我們應該期望在 20未來商業市場的 % 到 25% 的市場份額。同樣，所有這一切本質上都是非常投機的，但基於我們對迄今為止市場的分析以及我們預計整個 COVID 疫苗市場未來的樣子。

Great. Maybe just a last one related to the financial guidance. Can we get a sense of the cash flow and the EPS kind of this year maybe beyond? Particularly, I think the moving piece may be related to OpEx. I think you have been saying the OpEx is lower this year versus last year, but to what extent? And also, how should we think about next year and the beyond?

偉大的。也許只是與財務指導有關的最後一個。我們能否對今年的現金流和每股收益有所了解？特別是，我認為移動部分可能與運營支出有關。我想你一直在說今年的 OpEx 比去年低，但到什麼程度呢？而且，我們應該如何考慮明年及以後的事情？

It might be best to leave the 2023 to a future conversation as we fully build out our commercial footprint. With respect to current year, you've got SG&A that came in at $108 million for the quarter. We do expect that to continue to trend up as we build out our capabilities. R&D, we do expect R&D to be materially lower year-over-year than last year. And of course, that's went to the factors I mentioned previously. Everything from capping of supply to inventory to at least for the first half of the year, lower clinical spend. And then finally, some favorability related to lease accounting.

隨著我們充分建立我們的商業足跡，最好將 2023 年留給未來的對話。就本年度而言，本季度的 SG&A 收入為 1.08 億美元。我們確實希望隨著我們能力的增強，這種趨勢會繼續上升。研發，我們確實預計研發將比去年同期大幅下降。當然，這是我之前提到的因素。從供應上限到庫存，至少在今年上半年，降低臨床支出。最後，一些與租賃會計相關的優惠。

And so we think about our cash position at $630 million, which reflected $1.4 billion in cash and a receivable of $200 million. You add to that the feedback we just shared that we have, call it, orders in hand through today's call in the range of $400 million, we feel good about our cash position as we continue to execute in the back half of 2022.

因此，我們認為我們的現金頭寸為 6.3 億美元，這反映了 14 億美元的現金和 2 億美元的應收賬款。您還添加了我們剛剛分享的反饋，即通過今天的電話會議，我們手頭有 4 億美元的訂單，我們對我們的現金狀況感到滿意，因為我們將在 2022 年下半年繼續執行。

Our next question comes from Mayank Mamtani with B. Riley.

我們的下一個問題來自 Mayank Mamtani 和 B. Riley。

Difficult numbers to digest there. So maybe just to follow up on the delivery versus invoicing process. Can you just clarify how does that differ for EU versus ex EU territories like Canada, Australia and U.K.? And if you are able to comment on where does the real-time inventory stand right now? And just going back to Jim's comment on how should we think about this write-down sort of going forward, and if that needs to be modeled into cost of sales going forward. And then I have a couple of follow-ups.

那裡很難消化數字。所以也許只是為了跟進交付與發票流程。您能否澄清一下歐盟與加拿大、澳大利亞和英國等前歐盟領土的區別？如果您能夠評論實時庫存現在在哪裡？回到吉姆關於我們應該如何考慮這種減記的評論，以及是否需要將其建模為未來的銷售成本。然後我有幾個跟進。

Okay. I'm happy to take, of course, the rev rec piece and then glad to speak to the $255 million charge we took this quarter in COGS and what it means prospectively. So with respect to our revenue recognition, it's uniform globally. And in all cases, it is upon transfer of title to our customers, which is uniformly when a customer takes possession of our product at their location. So that's true in Europe and elsewhere.

好的。當然，我很高興接受 rev rec 部分，然後很高興談論我們本季度在 COGS 中收取的 2.55 億美元費用以及這意味著什麼。因此，就我們的收入確認而言，它在全球範圍內是統一的。在所有情況下，都是在將所有權轉讓給我們的客戶時進行的，這通常是客戶在其所在地擁有我們的產品時。所以在歐洲和其他地方都是如此。

With respect to the $255 million charge, this is a function of both the COVAX omission of our expectation to deliver against an inventory build that we had otherwise -- an investment that we had otherwise been making to supply COVAX for quite some time. In addition to that, as we watch the market dynamics play out with respect to global supply and demand, certain raw materials and semi-finished goods were subject to potential expiry. And so what you are seeing in -- for us this quarter is a reflection of that, call it, recalibration. And it's -- I'm not sure you're tracking the earnings for our, call it, COVID peers. It's a very similar story elsewhere as well.

關於 2.55 億美元的費用，這是由於 COVAX 遺漏了我們預期的交付，而我們原本擁有的庫存構建——這是我們在相當長一段時間內一直在為供應 COVAX 而進行的投資。除此之外，隨著我們觀察全球供需的市場動態，某些原材料和半成品可能會到期。所以你所看到的——對我們來說，本季度是對這種情況的反映，稱之為重新校準。它是 - 我不確定你是否正在跟踪我們的收入，稱之為 COVID 同行。這在其他地方也是一個非常相似的故事。

Helpful clarification. And yes, that is the case for the 2 years also. And then on the booster label with EU and also, importantly, with the U.K. JCVI. Could you -- Filip, if you could give some update on how far along we are? And also on the U.K. shipments, what's the expectation to -- for that to commence? I appreciate the update on the revised contract you have.

有幫助的澄清。是的，這兩年也是如此。然後是歐盟的助推器標籤，重要的是，還有英國的 JCVI。您能否——菲利普，如果您能提供一些關於我們進展的最新情況嗎？還有在英國的出貨量上，對開始的期望是什麼？感謝您對修訂後的合同的更新。

And just maybe a higher-level question. As you track market share country-by-country where you do have the booster approval, are there any case studies one could reference to sort of think of vaccinate market share tracking versus the third or fourth booster shot of mRNA vaccine?

也許只是一個更高層次的問題。當您逐個跟踪您確實獲得加強批准的國家/地區的市場份額時，是否有任何案例研究可以參考疫苗市場份額跟踪與 mRNA 疫苗的第三次或第四次加強注射？

Right. So just as far as where we are with the booster indication in Europe and other territories, well, those are in process side. They have all the information. They have the same information. It was evaluated by the regulators in Japan, Australia and New Zealand where we've received favorable approvals. And we're just working through the process. My expectation is that we'll be hearing news from those regulators in the next handful of days to weeks. We don't control that process. Obviously, they do.

正確的。因此，就我們在歐洲和其他地區的助推器指示而言，這些都在進行中。他們擁有所有信息。他們有相同的信息。它由日本、澳大利亞和新西蘭的監管機構進行了評估，我們獲得了良好的批准。我們只是在完成這個過程。我的期望是，我們將在接下來的幾天到幾週內聽到這些監管機構的消息。我們不控制那個過程。顯然，他們確實如此。

What we do know where the data is available, where our vaccine is available alongside other vaccines is that people are making a choice. We are seeing people ask for vaccines in the booster indication, even though we don't have a label indication in certain territories such as in Korea or Australia, let's say. Actually, recently changed but when we look at the historic data before we got the label indication there.

我們所知道的數據在哪裡可用，我們的疫苗在哪裡可以與其他疫苗一起使用，是人們正在做出選擇。我們看到人們在加強指示中要求疫苗，即使我們在某些地區（例如韓國或澳大利亞）沒有標籤指示，比方說。實際上，最近發生了變化，但是當我們在獲得標籤指示之前查看歷史數據時。

So we know people are choosing to go there. The exact amount and how frequently they do that is really a function of the policy recommendations in each territory. So we know where we have relatively good recommendations such as Korea is happening at a very high rate compared to where we have more restricted recommendations, let's say, in Germany.

所以我們知道人們選擇去那裡。他們這樣做的確切數量和頻率實際上取決於每個地區的政策建議。因此，我們知道我們在哪裡有相對較好的推薦，比如韓國，與我們在德國有更多受限推薦的地方相比，發生率非常高。

And my final question on the capital allocation. Given the dynamics you guys talked about for cash burn and revenue recognition cadence, how might you be thinking of the convert that might be coming up in February? Could you provide some comments on that, please?

還有我關於資本分配的最後一個問題。鑑於你們談到的現金消耗和收入確認節奏的動態，您如何看待可能在 2 月份出現的轉換？請您對此發表一些意見好嗎？

Yes, certainly, certainly. So for folks who are familiar with our balance sheet, there's a $325 million convert that matures in February of next year. To date, we have not stated a specific intent to do anything with respect to, for example, refinancing or perhaps just simply paying off. We continue to have confidence in our forward-looking ability to deliver on our sales and generate cash flow. And we'll evaluate our options in the coming months as we think it best serve shareholders and dependent, of course, on capital markets dynamics.

是的，當然，當然。因此，對於熟悉我們資產負債表的人來說，明年 2 月將有 3.25 億美元的轉換到期。迄今為止，我們還沒有明確表示要採取任何行動，例如再融資或只是簡單地還清。我們繼續對我們實現銷售和產生現金流的前瞻性能力充滿信心。我們將在未來幾個月評估我們的選擇，因為我們認為它最能為股東服務，當然也取決於資本市場動態。

Our next question comes from Eric Joseph with JPMorgan.

我們的下一個問題來自摩根大通的 Eric Joseph。

I just wanted to pick up on the COGS expectation in the second half, given the write-downs this quarter. If we're looking at third-party data, there's still seemingly a fair amount of inventory in the EU that's yet to be end distributed. So I guess, can you talk a little bit about shelf expectations for Nuvaxovid? How much of the current inventory could rollover into 2023? Should we anticipate significant -- I guess, some amount of inventory on hand being at risk in the second half?

考慮到本季度的減記，我只想了解下半年的銷貨成本預期。如果我們查看第三方數據，歐盟似乎仍有相當數量的庫存尚未最終分配。所以我想，你能談談 Nuvaxovid 的貨架期望嗎？目前有多少庫存可以轉存到 2023 年？我們是否應該預料到重要的——我猜，手頭的一些庫存在下半年面臨風險？

And then -- just coming back to the U.S. revenue piece. If I heard correctly, you don't anticipate any additional product revenues from the U.S. this year. Nevertheless, I am curious to know whether if additional orders are made, whether they would count against the balance under the BARDA agreement of 110 million doses or whether you might look to move to a more traditional purchasing model sort of outside the existing contracts in earlier time frame for 2023 and beyond.

然後 - 回到美國的收入部分。如果我沒聽錯的話，你預計今年美國不會有任何額外的產品收入。儘管如此，我很想知道是否有額外的訂單，它們是否會計入 BARDA 協議下 1.1 億劑的餘額，或者您是否可能希望在早些時候轉向現有合同之外的更傳統的採購模式2023 年及以後的時間框架。

So Eric, there's a couple of pieces to parse out there. So the revenue and the write-off of products are somewhat related, and so Jim could talk more into that. But any expectation that we would have, inventory that would not be shipped, Jim has already reserved and made an adjustment for that. Any of the product that we expect to ship for the balance of the year will be on top of whatever inventories are sitting there. There are inventories that are our inventory that fall under what Jim's assessment would be. And then there are inventories that have already been invoiced to the customer.

所以埃里克，那裡有幾部分需要解析。所以收入和產品的核銷有些相關，所以吉姆可以更多地談論這一點。但是，如果我們有任何期望，即不會發貨的庫存，Jim 已經預訂並為此進行了調整。我們預計在今年餘下時間出貨的任何產品都將在現有庫存之上。有一些庫存屬於我們的庫存，屬於 Jim 的評估範圍。然後是已經向客戶開具發票的庫存。

Shipments in Q3 and Q4 and shipments that have been pushed off into Q1 and Q2 of next year will remain unaffected by those inventory levels. In fact, we see this expected wave of additional vaccine boosters taking place in the fall. I think that, that will help reduce some of the existing inventories of product that has been shipped. And then we already have -- are planning out what those shipments would be, as I said, for Q3 and Q4 and then what's ever pushed into 2023. So I think that captures that piece. Jim?

第三季度和第四季度的出貨量以及已推遲到明年第一季度和第二季度的出貨量將不受這些庫存水平的影響。事實上，我們看到這一預期的額外疫苗助推器浪潮將在秋季發生。我認為，這將有助於減少一些已發貨產品的現有庫存。然後我們已經 - 正如我所說的那樣，正在計劃第三季度和第四季度的出貨量，然後是 2023 年的出貨量。所以我認為這就是其中的一部分。吉姆?

And then maybe shelf life. Currently, we're at 9 months in most markets.

然後可能是保質期。目前，我們在大多數市場都處於 9 個月。

We would expect, as we get later on to the year, that shelf life would extend into 11 months, but don't have that shelf life extension yet.

我們預計，隨著今年晚些時候，保質期將延長至 11 個月，但還沒有延長保質期。

Exactly. With respect to the charge in the period of $255 million, approximately $150 million of that or $155 million of that related to inventory in various stages. You know you got raw materials, semifinished and finished goods. The share of that, which we felt could be subject to expiry we expensed. And then with respect to the remaining $100 million, this has to do with unavoidable fixed purchase commitments in future periods where we simply feel we no longer need to secure either manufacturing slots or certain raw materials. And so we took a charge for that as well. So those -- that's the breakdown of components.

確切地。關於 2.55 億美元期間的費用，其中約 1.5 億美元或 1.55 億美元與不同階段的存貨有關。你知道你有原材料、半成品和成品。我們認為可能會到期的那部分，我們已經支出了。然後關於剩餘的 1 億美元，這與未來期間不可避免的固定採購承諾有關，我們只是覺得我們不再需要確保製造槽或某些原材料。所以我們也為此負責。所以那些 - 那是組件的分解。

Now in terms of forward-looking, if we felt like there was more, we would have, of course, reserved for it today. And therefore, when we speak about our expected margins on a go-forward basis and specifically the high-income market, I shared that we expect gross margins in the area in the range of 70% to 85% based upon our standard cost. And that certainly continues to be the case.

現在就前瞻性而言，如果我們覺得還有更多，我們當然會在今天保留它。因此，當我們談到我們未來的預期利潤率，特別是高收入市場時，我分享說，根據我們的標準成本，我們預計該地區的毛利率在 70% 到 85% 之間。當然，情況仍然如此。

Our next question comes from Alec Stranahan with Bank of America.

我們的下一個問題來自美國銀行的 Alec Stranahan。

Just two quick ones from us. First, could you talk a bit more about the Phase III design for the combo vaccine? Have you reached an alignment with the FDA on endpoints at this point? And how should we think about a ballpark for enrollment to reach a meaningful effect size given the expected attack rate for both viruses?

我們只有兩個快速的。首先，您能多談談組合疫苗的 III 期設計嗎？在這一點上，您是否與 FDA 在端點上達成一致？考慮到這兩種病毒的預期攻擊率，我們應該如何考慮招生範圍以達到有意義的效果大小？

And secondly, and apologies if this was already asked, but curious whether your current APAs include optionality for strain-specific vaccines, should they become available or whether this would trigger additional contracts.

其次，如果已經問過這個問題，我很抱歉，但很好奇您當前的 APA 是否包括針對特定毒株的疫苗的可選性，它們是否可用，或者這是否會觸發額外的合同。

Well, the first question is for me. So we have not had our pre-Phase III meeting with the agency yet for -- and I'm assuming you're talking about the influenza/COVID combination vaccine. And we're going to do that after we get the results from our next study. Clearly, they are data driven, and they're going to want to see that data before they can give us final opinions on it. Although people have been running Phase III studies against flu for a while, so we have a pretty good idea at least what we'd like to do. But we haven't commented on any specifics on what that is that looks like.

好吧，第一個問題是給我的。所以我們還沒有與該機構舉行第三階段前的會議——我假設你在談論流感/ COVID 聯合疫苗。我們將在獲得下一項研究的結果後這樣做。顯然，他們是數據驅動的，他們會希望在給我們提供最終意見之前查看這些數據。儘管人們已經進行了一段時間的針對流感的 III 期研究，但我們至少對我們想做的事情有了一個很好的想法。但是我們沒有評論任何關於它是什麼樣子的細節。

As far as strain change provisions, there are some of the agreements that will allow for flexibility in strain change. And frankly, that is fine with us, given where we stand in our development activities. That provides for upside opportunity and the ability to ship very and strained product. Now there's not been a whole lot of clarity on a country-by-country basis as to what they want, most specifically and definitively has been the U.S. market seeking at least the bivalent for the mRNA vaccines. But all the conversations we've been having with U.K., Europe, Australia, New Zealand, Canada, et cetera, there have not been absolute decisions made regarding strain change product.

至於應變變化條款，有一些協議將允許應變變化的靈活性。坦率地說，考慮到我們在開發活動中所處的位置，這對我們來說很好。這提供了上行機會和運送非常緊張的產品的能力。現在，每個國家都不清楚他們想要什麼，最具體和明確的是美國市場至少在尋求 mRNA 疫苗的二價。但是，我們與英國、歐洲、澳大利亞、新西蘭、加拿大等進行的所有對話，都沒有就應變變化產品做出絕對的決定。

Next question comes from Mayank Mamtani with B. Riley.

下一個問題來自 Mayank Mamtani 和 B. Riley。

Just really quick, we get asked a lot about the time lines for BA.1-specific vaccine, which you have in the clinic and sort of the CMC scale-up process, how that's kind of progressed. And if you are looking to build any inventory for that versus wanting to work on the BA.5-specific vaccine, could you just sort of comment a little bit on both data and then the CMC-specific activities for that vaccine?

很快，我們被問到很多關於 BA.1 特異性疫苗的時間線，你在診所和 CMC 擴大規模的過程中，這是如何進展的。如果您希望為此建立任何庫存，而不是想要研究 BA.5 特異性疫苗，您能否對這兩個數據以及該疫苗的 CMC 特異性活動稍作評論？

Yes. It's Greg here. So the clinical trial, as Filip noted, has been enrolled, and we're doing the assays. And so we expect, towards the end of quarter 3, to provide the clinical result. We're actively working on BA.5, and our expectation is we can have a stockpile of material. However, we have to, of course, submit the regulatory package sometime in quarter 4. And so after that, we're not sure what the timing will be, how long it will take the FDA to review that.

是的。格雷格在這裡。因此，正如菲利普所指出的，臨床試驗已被註冊，我們正在進行化驗。因此，我們希望在第三季度末提供臨床結果。我們正在積極開發 BA.5，我們的期望是我們可以儲備大量材料。但是，我們當然必須在第 4 季度的某個時候提交監管包。因此，在那之後，我們不確定時間是什麼，FDA 需要多長時間來審查它。

So what just I would like to kind of recapitulate what Filip said, however, both -- and Stan as well, we're increasingly convinced that our current vaccine is suitable for deployment in the context of a boosting study. As you know, we provide very good data showing that our vaccine induces broadly -- antibodies broadly recognized variants, including BA.5 very nicely. And we're -- I think there's a fair amount of discussion currently with many of the customers on exactly what to do. We think there's a lot of merits in deploying our current Wuhan vaccine that is authorized in many countries being used as a booster. And obviously, in our data, it is really strongly inducing this broad recognition of antibodies that broadly recognize new variants when we boost. And we think there's a very strong case for deployment of that vaccine.

因此，我想概括一下 Filip 所說的話，然而，無論是 - 以及 Stan，我們都越來越相信我們目前的疫苗適合在加強研究的背景下部署。如您所知，我們提供了非常好的數據，表明我們的疫苗可廣泛誘導抗體廣泛識別變體，包括非常好的 BA.5。而且我們 - 我認為目前與許多客戶就該做什麼進行了大量討論。我們認為部署我們目前的武漢疫苗有很多優點，該疫苗在許多國家都被授權用作助推器。顯然，在我們的數據中，當我們增強時，它確實強烈地誘導了對廣泛識別新變體的抗體的廣泛識別。我們認為部署這種疫苗的理由非常充分。

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

問答環節到此結束。我想把會議轉回給 Stan Erck 做閉幕詞。

Thank you. Thanks to everyone for joining today's call. I'd probably close by thanking all of those who made possible the significant progress during the second quarter, including all of our employees, selfless contributions of our trial participants, the continued support from our partners around the world, and we look forward to reporting additional milestones in the coming months. So thanks for being on the call.

謝謝你。感謝大家加入今天的電話會議。最後，我可能要感謝所有在第二季度取得重大進展的人，包括我們所有的員工，我們的試驗參與者的無私貢獻，我們在世界各地的合作夥伴的持續支持，我們期待著報告未來幾個月的其他里程碑。所以感謝您接聽電話。

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。