Novavax Inc (NVAX) 2023 Q1 法說會逐字稿

Good morning, and welcome to Novavax' First Quarter 2023 Financial Results and Operational Highlights Conference Call. (Operator Instructions) Please note this event is being recorded.

早上好，歡迎來到 Novavax 2023 年第一季度財務業績和運營亮點電話會議。 （操作員說明）請注意正在記錄此事件。

I would now like to turn the conference over to Erika Schultz, Senior Director, Investor Relations. Please go ahead.

我現在想將會議轉交給投資者關係高級總監 Erika Schultz。請繼續。

Good morning, and thank you all for joining us today to discuss our first quarter 2023 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.

早上好，感謝大家今天加入我們，討論我們 2023 年第一季度的運營亮點和財務業績。宣布我們結果的新聞稿目前可在我們的網站 novavax.com 上獲取，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。

Please turn to Slide 2. Before we begin with prepared remarks, I need to remind you that this presentation includes forward-looking statements, including information related to the future of Novavax, its key strategic priorities, operating plans, objectives and prospects, its future financial or business performance conditions or strategies, including projections on revenue and reductions in expenses and its global restructuring and cost reduction initiatives.

請轉到幻燈片 2。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 的未來相關的信息、其關鍵戰略優先事項、運營計劃、目標和前景、其未來財務或業務績效狀況或戰略，包括對收入和支出減少的預測及其全球重組和成本削減計劃。

Key commercial goals, including transitioning to a traditional commercial model, future product demand trends, the ongoing development of our vaccine candidates, including advancing multiple variant strain, strain flection, 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 variants, the global market opportunities for our vaccine candidates, our manufacturing capacity and the future availability of our vaccine candidates and key upcoming milestones.

關鍵商業目標，包括向傳統商業模式的過渡、未來產品需求趨勢、我們候選疫苗的持續開發，包括推進多變異菌株、菌株變化、試驗和結果的預期時間、未來監管的範圍、時間和結果備案和行動。我們候選疫苗的功效、安全性和預期用途，包括針對 COVID 變體、我們候選疫苗的全球市場機會、我們的製造能力和我們候選疫苗的未來可用性以及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 morning and under the heading Risk Factors in our most recent Form 10-K and subsequent Form 10-Qs filed with the Securities and Exchange Commission and available at www.sec.gov and on our website at www.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，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標題“關於前瞻性陳述的注意事項”下。在我們今天早上發布的幻燈片中，我們最近向美國證券交易委員會提交的 10-K 表格和隨後的 10-Q 表格中的風險因素標題下，可在 www.sec.gov 和我們的網站 www.sec.gov 上獲取。 novavax.com 以及隨後向美國證券交易委員會提交的文件。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. This presentation also includes references to non-GAAP financial measure, which is forward-looking information for R&D and SG&A expense as adjusted to exclude onetime restructuring costs as described on this slide.

請轉到幻燈片 3。本演示文稿還包括對非 GAAP 財務指標的引用，這是針對研發和 SG&A 費用的前瞻性信息，經調整以排除本幻燈片中所述的一次性重組成本。

Please turn to Slide 4. Joining me today is John Jacobs, our President and CEO, who will provide an update on our progress during the quarter for our 3 key priorities. Additionally, Dr. Filip Dubovsky, President of Research and Development, will discuss our COVID variant strain development and pipeline; and John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on our commercial activities. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. Rick Crowley, Chief Operations Officer, will also be available for the Q&A section at the end of today's call.

請轉到幻燈片 4。今天和我一起的是我們的總裁兼首席執行官 John Jacobs，他將介紹本季度我們在 3 個關鍵優先事項方面的最新進展。此外，研發總裁 Filip Dubovsky 博士將討論我們的 COVID 變異株開發和管道；首席商務官兼首席商務官 John Trizzino 將介紹我們商業活動的最新情況。最後，首席財務官兼財務主管 Jim Kelly 將概述我們的財務業績。首席運營官里克克勞利 (Rick Crowley) 也將在今天的電話會議結束時出席問答環節。

I would now like to hand the call over to John Jacobs. Please turn to Slide 5.

我現在想把電話轉給 John Jacobs。請轉到幻燈片 5。

Thank you, Erika, and thank you, everyone, for joining us today to discuss our first quarter 2023 financial results and operational highlights. We have an especially eventful call today because in addition to our first quarter results, we will also be discussing significant measures we have taken to reduce our costs and restructure our organization, and we look forward to sharing some encouraging top line Phase II results for our combination flu COVID program.

謝謝 Erika，也謝謝大家今天加入我們，討論我們 2023 年第一季度的財務業績和運營亮點。我們今天有一個特別重要的電話會議，因為除了我們第一季度的業績外，我們還將討論我們為降低成本和重組我們的組織而採取的重要措施，我們期待為我們的第二階段分享一些令人鼓舞的頂線結果聯合流感 COVID 計劃。

The last time we worked together was in February for the Q4 earnings call, when I was only a few weeks on the job as the new CEO of Novavax. At that time, I shared with you why I was excited to join the company, my early observations and what our near-term top priorities are based on those early observations: first, delivering a competitive product for the upcoming fall season; second, reducing our rate of spend, managing our cash flow and evolving our scale and structure; and finally, driving additional value from our technology platform and portfolio.

我們最後一次合作是在 2 月份的第四季度財報電話會議上，當時我擔任 Novavax 新任首席執行官僅幾週時間。當時，我與大家分享了為什麼我很高興加入公司，我的早期觀察以及基於這些早期觀察的我們近期的首要任務是什麼：首先，為即將到來的秋季提供有競爭力的產品；其次，降低我們的支出率，管理我們的現金流並發展我們的規模和結構；最後，從我們的技術平台和產品組合中推動附加價值。

Now as I join you for the second time with a full quarter of listening and learning behind me, I must say that this recent experience has further strengthened my resolve and confirmed for me the strong potential that our company has to make a positive difference in global public health. As we continue to execute on our priorities, if successful, I believe we will place Novavax in a stronger position for future growth and value creation. I'm encouraged by the progress we've made to date. And while we know there are still significant challenges ahead of us before we can claim success, the leadership team and I will remain completely focused.

現在，當我第二次加入你們時，我已經聽了整整四分之一的時間，我必須說，最近的經歷進一步堅定了我的決心，並向我證實了我們公司必須在全球範圍內產生積極影響的強大潛力。公共衛生。隨著我們繼續執行我們的優先事項，如果成功，我相信我們將使 Novavax 在未來的增長和價值創造中處於更有利的地位。我對我們迄今為止取得的進展感到鼓舞。雖然我們知道在我們宣布成功之前仍然面臨著重大挑戰，但領導團隊和我將保持全神貫注。

During the quarter, we have taken decisive actions and made progress on each of our 3 priorities, which I would like to outline for you next. Let's talk about our first priority, delivering a competitive product for the upcoming 2023 fall vaccination season. This includes aligning our COVID vaccine with regulatory and public health guidance on strain selection and making our product available in the right quantities and in the smaller unit competitive product presentation.

在本季度，我們採取了果斷行動，並在我們的 3 個優先事項中的每一個方面都取得了進展，我想在接下來為您概述。讓我們談談我們的首要任務，為即將到來的 2023 年秋季疫苗接種季節提供有競爭力的產品。這包括使我們的 COVID 疫苗與菌株選擇方面的監管和公共衛生指南保持一致，並使我們的產品以正確的數量和較小的單位競爭產品展示形式提供。

Throughout the quarter, we have made significant progress on this priority. A critical component of which has been the collaborative relationship with the FDA and other global regulatory authorities as we prepare for the fall campaign. As part of that effort, and as we noted in the Q4 earnings call, we've been advancing multiple variant strain vaccine candidates in order to optimize our readiness for final strain selection for the upcoming fall season by the U.S. VRBPAC on June 15. Following the FDA's decision, we will then focus all necessary resources on advancing the required variant strain vaccine with the intent of having our product on the market for the fall vaccination campaign.

在整個季度中，我們在這一優先事項上取得了重大進展。在我們為秋季活動做準備時，其中一個重要組成部分是與 FDA 和其他全球監管機構的合作關係。作為這項工作的一部分，正如我們在第四季度財報電話會議中指出的那樣，我們一直在推進多種變異毒株候選疫苗，以優化我們為 6 月 15 日美國 VRBPAC 即將到來的秋季選擇最終毒株所做的準備。根據 FDA 的決定，我們將集中所有必要的資源來推進所需的變異株疫苗，目的是將我們的產品投放市場以進行秋季疫苗接種活動。

For the U.S., which will be the first market to evolve to a commercial purchasing model, John Trizzino, our Chief Commercial Officer, will talk about how we are preparing to make our vaccine available across the major distribution channels for the upcoming fall season. This includes significant progress in our U.S. commercial team build-out and our ongoing discussions and negotiations with customers ahead of the season.

對於美國，這將是第一個發展為商業採購模式的市場，我們的首席商務官 John Trizzino 將談論我們如何準備在即將到來的秋季通過主要分銷渠道提供我們的疫苗。這包括我們在美國商業團隊建設方面取得的重大進展，以及我們在賽季前與客戶進行的持續討論和談判。

Outside of the U.S., we are pleased to report that we have secured approximately $800 million in potential APA orders for 2023. We are encouraged by our progress in this area, and excited about the potential we have to positively impact global health of their updated vaccine this year. Assuming we execute successfully on our plans for the U.S. and ex U.S., we expect total revenue in the range of $1.4 billion to $1.6 billion for the year, inclusive of product sales and grants.

在美國以外，我們很高興地報告說，我們已經獲得了大約 8 億美元的 2023 年潛在 APA 訂單。我們對我們在這一領域取得的進展感到鼓舞，並對我們有可能對他們更新的疫苗的全球健康產生積極影響感到興奮今年。假設我們成功執行了美國和美國以外的計劃，我們預計今年的總收入將在 14 億美元至 16 億美元之間，包括產品銷售和贈款。

Let's now move on to priority #2, which is to reduce our rate of spend, manage our cash flow and evolve our scale and structure. Today, we announced that we are implementing a global restructuring and cost reduction initiative, which will significantly reduce our expenses while retaining the capabilities we need to help drive results and build value in the future.

現在讓我們繼續優先事項#2，即降低我們的支出率，管理我們的現金流並發展我們的規模和結構。今天，我們宣布我們正在實施一項全球重組和成本削減計劃，這將顯著減少我們的開支，同時保留我們在未來幫助推動成果和創造價值所需的能力。

When fully implemented, we expect these actions will reduce our combined annual R&D and SG&A expenses for 2024 by approximately 40% to 50% when compared to 2022. Included in the plan is an approximate 25% reduction of our global workforce as well as a consolidation of our global facilities and infrastructure. While reducing our workforce was certainly a difficult decision. This was necessary as part of a comprehensive effort to better align our infrastructure and scale to the current global opportunity for our vaccine and ultimately to enhance our ability to help protect global health.

全面實施後，我們預計這些行動將使我們 2024 年的年度研發和 SG&A 費用與 2022 年相比減少約 40% 至 50%。該計劃包括將我們的全球勞動力減少約 25% 以及合併我們的全球設施和基礎設施。雖然裁員當然是一個艱難的決定。作為全面努力的一部分，這是必要的，以便更好地調整我們的基礎設施和規模，以適應我們疫苗當前的全球機會，並最終增強我們幫助保護全球健康的能力。

In addition to significantly reducing our scope, scale and expense base in R&D and SG&A, we are aggressively addressing our significant onetime current liabilities. To this end, we are pleased to report that since our last interaction, we've made significant progress in reducing these liabilities. You will hear more today about our cost management, our restructuring and cash flow from Jim Kelly, our CFO, later in the call.

除了大幅縮減我們在研發和 SG&A 方面的範圍、規模和費用基礎外，我們還在積極解決我們重大的一次性流動負債問題。為此，我們很高興地報告，自上次互動以來，我們在減少這些負債方面取得了重大進展。您今天將從我們的首席財務官 Jim Kelly 那裡聽到更多關於我們的成本管理、重組和現金流的信息。

And finally, let's discuss priority 3, which is to leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond Nuvaxovid alone. We continue to explore opportunities and strategies to unlock additional value from our pipeline and our technology platform, including our Matrix-M adjuvant.

最後，讓我們討論優先事項 3，即利用我們的技術平台、我們的能力和我們的資產組合來推動 Nuvaxovid 之外的附加價值。我們繼續探索機會和戰略，以從我們的管道和技術平台（包括我們的 Matrix-M 佐劑）中釋放更多價值。

Regarding our pipeline, we are pleased today to announce positive results from our Phase II COVID influenza combination and stand-alone influenza vaccine dose-confirming trial. Dr. Filip Dubovsky will update you on these data later in the call. Depending on the outcome of the full data set, which we expect to receive over the coming months, we will evaluate our options to advance this program through strategic collaborations and/or other financing alternatives. These positive results further validate our technology platform and are another example of the potential of our science to contribute to global public health.

關於我們的管道，我們今天很高興地宣布我們的 II 期 COVID 流感組合和獨立流感疫苗劑量確認試驗的積極結果。 Filip Dubovsky 博士將在稍後的電話會議中向您更新這些數據。根據我們預計在未來幾個月收到的完整數據集的結果，我們將評估我們的選擇，以通過戰略合作和/或其他融資方案推進該計劃。這些積極的結果進一步驗證了我們的技術平台，並且是我們的科學為全球公共衛生做出貢獻的潛力的另一個例子。

Additionally, regarding our Matrix-M adjuvant, we continue to evaluate opportunities and advanced partnerships to leverage this unique asset. This includes our ongoing partnership with the Serum Institute of India for their malaria vaccine R21 that is formulated with our Matrix-M adjuvant. This vaccine has now been authorized in Ghana and Nigeria. The approval of this novel malaria vaccine with our Matrix-M adjuvant is another example of how we are working to extract additional value from our technology platform and our assets.

此外，關於我們的 Matrix-M 佐劑，我們繼續評估機會和高級合作夥伴關係以利用這一獨特資產。這包括我們與印度血清研究所持續合作開發使用我們的 Matrix-M 佐劑配製的瘧疾疫苗 R21。這種疫苗現已在加納和尼日利亞獲得批准。這種帶有我們的 Matrix-M 佐劑的新型瘧疾疫苗獲得批准是我們如何努力從我們的技術平台和資產中獲取額外價值的另一個例子。

Regarding business and corporate development, we've been enhancing our internal focus and efforts on business and corporate development opportunities with the intention of positioning Novavax to build additional value and opportunity through our proven technology platform and our pipeline of early and mid-stage vaccine candidates. This includes the potential for out-licensing, collaborations, partnerships, joint ventures, co-promotion and other types of opportunities over time.

在業務和企業發展方面，我們一直在加強我們對業務和企業發展機會的內部關注和努力，目的是通過我們成熟的技術平台和我們的早期和中期候選疫苗管道，將 Novavax 定位為創造額外的價值和機會.隨著時間的推移，這包括對外許可、合作、夥伴關係、合資企業、共同推廣和其他類型機會的潛力。

As I mentioned in my opening comments, my experience at Novavax the past several months has helped to reinforce my belief in the potential of our company, and I am encouraged by our recent progress. I also believe that our core business is robust, and that our strategy is the right one to help us achieve our objectives.

正如我在開場白中提到的，過去幾個月我在 Novavax 的經歷幫助我更加相信我們公司的潛力，我對我們最近的進展感到鼓舞。我也相信我們的核心業務是穩健的，我們的戰略是幫助我們實現目標的正確戰略。

Let me summarize those objectives, one more time for you as I close my opening comments. First, we intend to make our business even stronger through the successful development and launch of a competitive product for the fall vaccination season. At the same time, we are working towards building a solid financial foundation to help support long-term growth and value creation. And finally, we are working to leverage our proven technology platform, pipeline of early and mid-stage assets and fully integrated global capabilities to drive additional value over the long term via clinical business and corporate development activities.

讓我總結一下這些目標，在我結束我的開場評論時再給你們一次。首先，我們打算通過在秋季疫苗接種季節成功開發和推出具有競爭力的產品，使我們的業務更加強大。與此同時，我們正在努力建立堅實的財務基礎，以幫助支持長期增長和價值創造。最後，我們正在努力利用我們成熟的技術平台、早期和中期資產管道以及完全整合的全球能力，通過臨床業務和企業發展活動在長期內推動附加價值。

As I noted during our Q4 call, we intend to routinely share with you both our potential opportunities as well as the challenges we face and to provide balance and perspective on our business. With that in mind, let me be clear, 2023 will continue to be a challenging year for Novavax. Yes, we have made progress during the quarter but we still face several challenges and have significant work to do before we can fully achieve our objectives for the year.

正如我在第四季度電話會議中指出的那樣，我們打算定期與您分享我們的潛在機遇和我們面臨的挑戰，並提供有關我們業務的平衡和觀點。考慮到這一點，讓我明確一點，2023 年對 Novavax 來說將繼續是充滿挑戰的一年。是的，我們在本季度取得了進展，但我們仍然面臨一些挑戰，並且在我們能夠完全實現今年的目標之前還有大量工作要做。

In the coming months, our commitment is that we will continue to focus on our 3 priorities and put forward our best efforts in all that we do. And we will do so with gratitude for the ongoing support of our key stakeholders.

在接下來的幾個月裡，我們承諾將繼續專注於我們的 3 個優先事項，並在我們所做的一切中盡最大努力。我們將感謝主要利益相關者的持續支持。

Now I'd like to hand it over to additional members of the team to discuss our results from the quarter and in more detail, beginning with Filip Dubovsky to discuss updates for our pipeline and COVID variant strategy. Filip?

現在我想把它交給團隊的其他成員來討論我們本季度的結果，並更詳細地討論我們的結果，從 Filip Dubovsky 開始討論我們的管道和 COVID 變體策略的更新。菲利普？

Thanks, John. Please turn to Slide 6. Our research and development program remains focused on our COVID vaccine. While we have multiple ongoing studies to generate additional data needed to expand our label, today, I will update you on our variant strategy in preparation for the '23 fall vaccination season which, as John discussed, is our #1 priority.

謝謝，約翰。請轉到幻燈片 6。我們的研發計劃仍然專注於我們的 COVID 疫苗。雖然我們正在進行多項研究以生成擴展我們的標籤所需的額外數據，但今天，我將向您介紹我們的變體策略，為 23 年秋季疫苗接種季節做準備，正如 John 所討論的那樣，這是我們的第一要務。

We also continue to advance our stand-alone influenza and COVID influenza combination vaccine candidates, and I'll show you some preliminary top line data from our Phase II study. Development of our other pipeline assets, including RSV, remains paused, allowing us to focus our resources on the programs that are critical to our near-term success.

我們還將繼續推進我們的獨立流感和 COVID 流感聯合候選疫苗，我將向您展示我們 II 期研究的一些初步頂線數據。我們其他管道資產（包括 RSV）的開發仍處於暫停狀態，這使我們能夠將資源集中在對我們近期成功至關重要的項目上。

Okay, let's turn to Slide 7 and discuss our variant strategy. On our last earnings call, we described our approach to developing and evaluating vaccines for different variants. We have executed that strategy and continue to refine variant strain development based on evolving epidemiologic data and ongoing dialogue with the global regulators. Despite in this table are the recent variants we have progressed into our variant development platform. Whenever a new variant emerges, we manufacture the variants spike protein, conduct preclinical studies to understand the variant's ability to cross neutralize or escape immune responses from other strains.

好的，讓我們轉到幻燈片 7 並討論我們的變體策略。在我們上次的財報電話會議上，我們描述了我們開發和評估不同變體疫苗的方法。我們已經執行了該策略，並根據不斷發展的流行病學數據和與全球監管機構的持續對話，繼續改進變異菌株的開發。儘管在這個表中是我們已經發展到我們的變體開發平台的最新變體。每當出現新變體時，我們都會製造變體刺突蛋白，進行臨床前研究以了解變體交叉中和或逃避其他菌株免疫反應的能力。

The variants that continue to be of concern are advanced into production of GMP master virus seed and then into large-scale manufacturer, if warranted. This manufactured vaccine can be used for clinical studies or for commercial release. Based on regulatory input, our currently candidate is XBB.1.5, which we have progressed into manufacturing of multiple 6,000 liter batches. XBB.1.6 is also of interest. And although there's only a single immunoacid difference, the receptor buying domain from XBB.1.5, we're making a master virus seed to be prepared for the vaccine composition announcement. Based on our close interaction with the Global Public Health agencies, we remain optimistic that this strategy has the potential to minimize the time between strain selection and delivering our vaccine this fall.

如果有必要，繼續關注的變體將進入 GMP 主病毒種子的生產，然後進入大規模製造商。這種製造的疫苗可用於臨床研究或商業發布。根據監管機構的意見，我們目前的候選藥物是 XBB.1.5，我們已經開始生產 6,000 升多個批次。 XBB.1.6 也很有趣。雖然只有一個免疫酸差異，即來自 XBB.1.5 的受體購買域，但我們正在製作一個主病毒種子，為疫苗成分公告做準備。基於我們與全球公共衛生機構的密切互動，我們仍然樂觀地認為，這一戰略有可能最大限度地縮短菌株選擇和今年秋天交付疫苗之間的時間。

Please move to Slide 8, so I can remind you of our ongoing strain change study. In the first quarter, Part 2 of Study 311 depicted on the right-hand side of the slide to evaluate our prototype strain vaccine and BA.5 variant vaccine in a bivalent containing prototype plus BA.5. Enrollment is complete and we expect top line results midyear. This study is one of the prerequisites for seeking regulatory approval for the new composition for the '23, '24 vaccine. We previously conducted a companion study with BA.1 variant and bivalent and therefore, anticipate similarly successful results in the current study.

請轉到幻燈片 8，這樣我可以提醒您我們正在進行的應變變化研究。在第一季度，幻燈片右側描述了 Study 311 的第 2 部分，以評估我們的原型毒株疫苗和 BA.5 變體疫苗在含有原型加 BA.5 的二價疫苗中的作用。註冊已完成，我們預計年中將取得頂級成績。這項研究是為 '23、'24 疫苗的新成分尋求監管批准的先決條件之一。我們之前對 BA.1 變體和二價進行了一項伴隨研究，因此預計在當前研究中會取得類似的成功結果。

Okay, let's turn to Slide 9 and 10 to discuss our stand-alone influenza and COVID influenza combination vaccines. Before I share preliminary data from the Phase II trial, I want to remind you that we previously reported on our successful Phase III study with quadrivalent influenza as well as a Phase I/II combination study, which demonstrated that influenza COVID vaccine is feasible with our technology. In fact, we believe our technology is particularly well suited for combination vaccines because large amounts of antigens can be incorporated without impacting tolerability. This is a feature that not all vaccine platforms share.

好的，讓我們轉到幻燈片 9 和 10 來討論我們的獨立流感疫苗和 COVID 流感聯合疫苗。在我分享 II 期試驗的初步數據之前，我想提醒大家，我們之前曾報導過我們成功的四價流感 III 期研究以及 I/II 期聯合研究，這表明流感 COVID 疫苗是可行的技術。事實上，我們相信我們的技術特別適合聯合疫苗，因為可以在不影響耐受性的情況下摻入大量抗原。這是並非所有疫苗平台都具有的功能。

So let's turn to Slide 11 and review the Phase II study design. This is a Phase II dose confirming study and is not a provisional registrational trial. In fact, the primary endpoint is evaluating safety although there are multiple secondary and exploratory immunogenicity endpoints. These endpoints were designed to inform which formulations could be advanced into late-stage development for the combination vaccine by evaluating different antigen and adjuvant dose ranges. No hypothesis testing was prespecified.

因此，讓我們轉到幻燈片 11 並回顧 II 期研究設計。這是一項 II 期劑量確認研究，不是臨時註冊試驗。事實上，主要終點是評估安全性，儘管有多個次要和探索性免疫原性終點。這些終點旨在通過評估不同的抗原和佐劑劑量範圍，告知哪些製劑可以進入聯合疫苗的後期開發階段。沒有預先指定假設檢驗。

As you can see, this is a complicated design of experiment study with 20 different treatment groups. Once all the data is available, it will be entered into a 3-dimensional computational model to identify the optimal dose levels. We also took the opportunity to explore high-dose COVID vaccine formulations, which I'll share with you later.

如您所見，這是一個複雜的實驗研究設計，有 20 個不同的治療組。一旦所有數據可用，就會將其輸入 3 維計算模型以確定最佳劑量水平。我們也藉此機會探索了高劑量 COVID 疫苗的配方，稍後我將與大家分享。

We enrolled 1,575 adults 50 to 80 years of age. 95% had previously received 3 or 4 doses of COVID vaccine with the last dose a median of 28 weeks prior to being enrolled. The data that is available today is safety through day 21 and anti-SIgG and neutralization responses as well as wild-type HAI for the 4 strains included in the vaccine. Additional immunogenetic data will be available over the next 2 to 3 months, including cellular immuno responses, influenza, microneutralization responses, immuno responses to strains and HAI against egg-adapted strains.

我們招募了 1,575 名 50 至 80 歲的成年人。 95% 的人之前接種過 3 劑或 4 劑 COVID 疫苗，最後一劑接種時間中位數為登記前 28 週。今天可用的數據是疫苗中包含的 4 種毒株在第 21 天的安全性和抗 SIgG 和中和反應以及野生型 HAI。在接下來的 2 到 3 個月內將提供更多的免疫遺傳學數據，包括細胞免疫反應、流感、微量中和反應、對菌株的免疫反應和針對雞蛋適應菌株的 HAI。

Please advance to Slide 12 to look at high-level safety. Overall, the stand-alone influenza and combination vaccines had a resharing preliminary safety profile and the reactogenicity was clinically indistinguishable from the licensed influenza comparators. As we expected from the small data set, there were no adverse events of special interest, no potential immune-mediated medical conditions and no treatment-related SAEs. Unsolicited adverse events occurred in less than 25% of any group and were consistent with diagnoses in older adult populations.

請轉到幻燈片 12 查看高級安全性。總體而言，獨立的流感疫苗和聯合疫苗具有重新共享的初步安全性，並且反應原性在臨床上與獲得許可的流感比較劑無法區分。正如我們從小數據集中預期的那樣，沒有特別關注的不良事件，沒有潛在的免疫介導的醫療狀況，也沒有與治療相關的嚴重不良事件。未經請求的不良事件在任何組中的發生率均低於 25%，並且與老年人群的診斷一致。

The local and systemic symptoms were mostly mild and moderate, and it recurred rates comparable to the license influenza competitors. We did not observe a consistent pattern of increased reactogenicity as the adjuvant and antigen loads were increased. This seems to be a hallmark of our technology and is an appealing feature when developing combination vaccines.

局部和全身症狀大多為輕度和中度，復發率與流感競爭對手相當。隨著佐劑和抗原負荷的增加，我們沒有觀察到反應原性增加的一致模式。這似乎是我們技術的標誌，並且在開發聯合疫苗時是一個吸引人的特徵。

Let's go to Slide 13, which describes the key competitors for our stand-alone flu vaccine. For the stand-alone quadrivalent influenza vaccine, we evaluated 3 different hemagglutinin dosage levels formulated with 75 micrograms of Matrix-M adjuvant. These were compared to 2 licensed premium price vaccines. Some preliminary data is presented on Slide 14. Presented here are the wild-type HAI results of our vaccine with 30, 45 and 60 micrograms of each strain compared to Fluzone high-dose and adjuvanted FLUAD. The 60-microgram dose is our selected dose level and was used in the previous Phase III study.

讓我們轉到幻燈片 13，它描述了我們的獨立流感疫苗的主要競爭對手。對於獨立的四價流感疫苗，我們評估了用 75 微克 Matrix-M 佐劑配製的 3 種不同的血凝素劑量水平。這些與 2 種許可的溢價疫苗進行了比較。一些初步數據顯示在幻燈片 14 上。這裡顯示的是我們疫苗的野生型 HAI 結果，與 Fluzone 高劑量和佐劑 FLUAD 相比，每種菌株分別為 30、45 和 60 微克。 60 微克劑量是我們選擇的劑量水平，並用於之前的 III 期研究。

Although the noninferiority endpoints was not prespecified or specifically powered for this, an ad hoc analysis indicated immuno responses were noninferior for all 4 strains for both competitor vaccines. For H1N1, the HAI for our vaccine was 44% greater than both Fluzone High-Dose and FLUAD. For H3N2, which has been a problem for all vaccines in recent years, we were 89% and 55% (sic) [56%] better. B/Victoria, we were noninferior to Fluzone high dose and 31% greater for FLUAD and for B/Yamagata, we were not inferior to Fluzone High Dose and 32% greater than FLUAD. We've seen lower HAIs for B/Yamagata in previous studies and expect this difference to resolve when we eventually receive the microneutralization data. Also B/Yamagata is not circulating over the past couple of years and may not be relevant. While we still need to analyze other immune responses, this data supports our belief that our technology may play a role in developing a better influenza vaccine.

儘管非劣效性終點沒有預先指定或為此專門提供動力，但一項特別分析表明，兩種競爭疫苗的所有 4 種毒株的免疫反應都是非劣效性的。對於 H1N1，我們疫苗的 HAI 比 Fluzone High-Dose 和 FLUAD 高 44%。對於近年來所有疫苗都存在的問題 H3N2，我們分別提高了 89% 和 55% (sic) [56%]。 B/Victoria，我們不劣於 Fluzone 高劑量，FLUAD 高 31%；對於 B/Yamagata，我們不劣於 Fluzone 高劑量，比 FLUAD 高 32%。在之前的研究中，我們已經看到 B/Yamagata 的 HAI 較低，並期望當我們最終收到微量中和數據時，這種差異會得到解決。此外，B/Yamagata 在過去幾年沒有流通，可能不相關。雖然我們仍然需要分析其他免疫反應，但這些數據支持我們的信念，即我們的技術可能在開發更好的流感疫苗方面發揮作用。

Okay. Let's go to Slide 15 and talk about combination vaccines. We evaluated 3 different COVID dosage levels, 3 different hemagglutinin dosage levels and 2 different Matrix-M levels for a total of 11 independent formulations. The anti-S and COVID neutralization responses were compared to our authorized COVID vaccine and influenza HAI were compared to Fluzone high-dose and adjuvanted FLUAD. I won't show you all our data for all 11 formulations, instead, I'll show you data for a couple of formulations that performed well. Until we receive and analyze the rest of the immune data, we won't be able to make a final determination of the formulation we intend to advance.

好的。讓我們轉到幻燈片 15 並討論聯合疫苗。我們評估了 3 種不同的 COVID 劑量水平、3 種不同的血凝素劑量水平和 2 種不同的 Matrix-M 水平，共計 11 種獨立製劑。將抗 S 和 COVID 中和反應與我們授權的 COVID 疫苗進行比較，並將流感 HAI 與 Fluzone 高劑量和佐劑 FLUAD 進行比較。我不會向您展示所有 11 種配方的所有數據，而是向您展示一些表現良好的配方的數據。在我們收到並分析其餘的免疫數據之前，我們將無法對我們打算推進的配方做出最終決定。

Let's turn to Slide 16. On the left-hand side of the slide, our 2 combination vaccines in black and teal compared to our authorized cover vaccine depicted here in a solid red bar. The combination vaccine achieved both IgG and neutralizing levels comparable to NVX 2373. In fact, the new titles were about threefold higher than seen in our successful Phase III study in unprimed adults, giving us additional confidence of its potential performance.

讓我們轉到幻燈片 16。在幻燈片的左側，我們的 2 種黑色和藍綠色組合疫苗與此處以實心紅色條顯示的我們授權的覆蓋疫苗相比。該組合疫苗達到了與 NVX 2373 相當的 IgG 和中和水平。事實上，新標題比我們在未接種疫苗的成人中成功進行的 III 期研究中所見的結果高出約三倍，這使我們對其潛在性能更有信心。

On the right-hand side of the slide, the 2 combination formulations are compared to Fluzone high dose in a solid orange bar and FLUAD in a solid purple bar. For A strains, the combination levels were greater than that for Fluzone high dose and FLUAD and for the B strains, the responses were similar. Although for B/Yamagata high dose Fluzone did have a higher point estimate. Clearly, these results would have been more favorable and the comparator that we use for the standard dose license influenza vaccine. Overall, based on the preliminary data, we believe we have identified at least 2 combination vaccine formulations that could be advanced into late-stage development.

在幻燈片的右側，將 2 種組合配方與實心橙色條中的 Fluzone 高劑量和實心紫色條中的 FLUAD 進行了比較。對於 A 菌株，組合水平高於 Fluzone 高劑量和 FLUAD，而對於 B 菌株，反應相似。儘管對於 B/Yamagata 高劑量 Fluzone 確實有更高的點估計。顯然，這些結果會更有利，並且我們使用標準劑量許可證流感疫苗的比較。總體而言，根據初步數據，我們認為我們已經確定了至少 2 種可以進入後期開發的聯合疫苗製劑。

Okay, let's go to Slide 17 and look at some high-dose COVID data. Shown here is a dose ranging from 5 micrograms to 35 micrograms of spike antigen in 50 micrograms of Matrix-M adjuvant. In these well-primed individuals, we hypothesized a larger antigen dose will lead to a better immune response. But this was not true in COVID naive individuals where 5 micrograms and 25 performed comparably. We will be looking not just for increase in magnitude but also durability and breadth of immune response. The highest dose COVID vaccine achieved a statistically significant increase of approximately 30% for anti-SIgG and neutralization compared to Novavax's prototype COVID-19 vaccine. We're planning to conduct a Phase II study in the third quarter of this year to explore the use of high-dose Nuvaxovid as an annual vaccine for older adults. The study will be done with XBB.1.5 vaccine.

好的，讓我們轉到幻燈片 17 並查看一些高劑量 COVID 數據。這裡顯示的是在 50 微克 Matrix-M 佐劑中加入 5 微克至 35 微克刺突抗原的劑量。在這些準備充分的個體中，我們假設更大的抗原劑量會導致更好的免疫反應。但這在 5 微克和 25 微克表現相當的 COVID 天真的個體中並非如此。我們不僅要尋找幅度的增加，還要尋找免疫反應的持久性和廣度。與 Novavax 的原型 COVID-19疫苗相比，最高劑量的 COVID 疫苗在抗 SIgG 和中和方面實現了約 30% 的統計顯著增加。我們計劃在今年第三季度進行一項 II 期研究，以探索使用高劑量 Nuvaxovid 作為老年人的年度疫苗。該研究將使用 XBB.1.5 疫苗進行。

Please turn to Slide 18, and I'll sum this up. So for our stand-alone flu vaccine, we observed a safety and reactogenicity profile that was comparable to the 2 license influenza vaccines, but the immune responses were favorable compared to these market leaders. If we have selected a standard dose comparator, the differences would have been even greater. The additional immune endpoint will further define the value of this vaccine, but in my opinion, the data we've shared today significantly increases probably of technical success for future clinical development.

請轉到幻燈片 18，我將對此進行總結。因此，對於我們的獨立流感疫苗，我們觀察到的安全性和反應原性與 2 個許可的流感疫苗相當，但與這些市場領導者相比，免疫反應是有利的。如果我們選擇標準劑量比較器，差異會更大。額外的免疫終點將進一步定義這種疫苗的價值，但在我看來，我們今天分享的數據顯著增加了未來臨床開發技術成功的可能性。

For our COVID influenza combination, the reactogenicity was once again comparable to license influenza vaccines. And based on the anti-COVID and influenza HAI responses, we believe we've identified at least 2 formulations that could be advanced into late-stage development. Essentially, the combination vaccine appears to be immulogically on par with authorized and licensed competitors. We await further data to make a final selection.

對於我們的 COVID 流感組合，反應原性再次與許可流感疫苗相當。基於抗 COVID 和流感 HAI 反應，我們相信我們已經確定了至少兩種可以進入後期開發的製劑。從本質上講，組合疫苗似乎在免疫學上與獲得授權和許可的競爭產品不相上下。我們等待進一步的數據來做出最終選擇。

And for our high-dose COVID vaccine candidate, we believe the preliminary safety and tolerability profile looks promising, and there's some indication of higher immune responses with higher dosage levels. We're planning a Phase II study with XBB.1.5 in third quarter as the next stage of development with special attention paid to the breadth, durability of immune responses. We also know that our vaccine induces mucosal immune responses in non-human primates, so we plan on measuring those as we select our final high-dose formulation for animal vaccination.

對於我們的高劑量 COVID 候選疫苗，我們認為初步的安全性和耐受性情況看起來很有希望，並且有跡象表明更高的劑量水平會產生更高的免疫反應。我們計劃在第三季度對 XBB.1.5 進行 II 期研究，作為下一階段的開發，特別關注免疫反應的廣度和持久性。我們還知道我們的疫苗會在非人類靈長類動物中誘導粘膜免疫反應，因此我們計劃在選擇用於動物疫苗接種的最終高劑量製劑時測量這些反應。

With that, I'll hand it over to John Trizzino to provide an update on our commercial activities.

有了這個，我將把它交給 John Trizzino 來提供我們商業活動的最新情況。

Thanks, Filip. Please turn to Slide 19 and then Slide 20. As key markets transition to more traditional commercial models, we are gaining more visibility into the expected size of the long-term COVID vaccine market. We remain confident in an ongoing need for annual seasonal vaccination, with likely demand in the U.S. in 2023 of approximately 100 million doses. We believe it is reasonable to think this is approximately $7 billion U.S. market with a total global demand greater than $15 billion.

謝謝，菲利普。請轉到幻燈片 19，然後轉到幻燈片 20。隨著主要市場向更傳統的商業模式過渡，我們對長期 COVID 疫苗市場的預期規模有了更多了解。我們仍然對每年季節性疫苗接種的持續需求充滿信心，2023 年美國可能需要大約 1 億劑疫苗。我們認為有理由認為這是一個價值約 70 億美元的美國市場，全球總需求超過 150 億美元。

Please turn to Slide 21. I'd like to discuss our recent progress and commercial readiness efforts to prepare for the 2023 fall vaccination season in the U.S. and rest of world. Beginning with the U.S., we delivered doses during the first quarter under our modified agreement with the U.S. government for up to 1.5 million doses, which importantly maintains access to our protein-based option in advance of the fall season. This included initial delivery of our product in a 5 dose trial presentation in March 2023.

請轉到幻燈片 21。我想討論我們最近的進展和商業準備工作，為美國和世界其他地區的 2023 年秋季疫苗接種季做準備。從美國開始，我們根據與美國政府修改後的協議在第一季度交付了多達 150 萬劑的劑量，這很重要，這在秋季之前保持了我們基於蛋白質的選擇。這包括在 2023 年 3 月的 5 劑量試驗演示中首次交付我們的產品。

In parallel, we are preparing for the transition to a commercial market in the U.S., utilizing the existing flu vaccine logistics and go-to-market infrastructure. Today, we have a fully deployed commercial team across the U.S. Canada, EU and U.K. that have established relationships with key commercial stakeholders and vaccine providers across all distribution channels who are actively working towards ensuring our vaccine is available to consumers at key points of service for the fall season.

與此同時，我們正在準備過渡到美國的商業市場，利用現有的流感疫苗物流和上市基礎設施。今天，我們在美國、加拿大、歐盟和英國擁有一支全面部署的商業團隊，他們與所有分銷渠道的主要商業利益相關者和疫苗供應商建立了關係，他們積極致力於確保我們的疫苗在關鍵服務點提供給消費者秋天的季節。

This includes ongoing discussions with all major retail pharmacies nationwide, educating health care providers and pharmacists about our COVID vaccine across the country, engagement with distributors, physician-buying groups, doctors' offices and integrated delivery networks, coordinating with the U.S. government to provide vaccines through various national public health programs, and we are finalizing our participation in the CDC, VFC and VA programs this season.

這包括與全國所有主要零售藥店的持續討論，在全國范圍內就我們的 COVID 疫苗對醫療保健提供者和藥劑師進行教育，與分銷商、醫生購買團體、醫生辦公室和綜合交付網絡進行接觸，與美國政府協調提供疫苗通過各種國家公共衛生計劃，我們正在完成本賽季對 CDC、VFC 和 VA 計劃的參與。

We are closely monitoring the COVID vaccine market to inform our pricing strategy. We expect our strategy will allow us to be competitively positioned in the U.S. market and will provide support from public and private payers consistent with established vaccine payer infrastructure. We are also preparing our BLA submission and expect to file with the FDA in the second half of 2023. While this is an important milestone, we will be able to sell our vaccine in the fall season under emergency use authorization.

我們正在密切監控 COVID 疫苗市場，以告知我們的定價策略。我們預計我們的戰略將使我們能夠在美國市場上處於競爭地位，並將提供與已建立的疫苗支付基礎設施一致的公共和私人支付者的支持。我們還在準備 BLA 提交，預計將在 2023 年下半年向 FDA 提交文件。雖然這是一個重要的里程碑，但我們將能夠在獲得緊急使用授權的情況下在秋季銷售我們的疫苗。

Now I will review key global commercial activities for 2023 fall vaccination season and beyond. We are enabling reliable access to Nuvaxovid by leveraging our commercial footprint and priority markets to drive demand and we plan to continue to deliver doses against our outstanding APAs and have secured approximately $800 million in APA orders for 2023 based upon committed delivery schedules subject to updated variant manufacturing and regulatory approvals. We expect to deliver the remainder of our APAs in '24 and '25.

現在，我將回顧 2023 年秋季疫苗接種季節及以後的主要全球商業活動。我們通過利用我們的商業足跡和優先市場來推動需求，從而實現對 Nuvaxovid 的可靠訪問，我們計劃繼續根據我們未完成的 APA 提供劑量，並根據承諾的交付時間表獲得 2023 年約 8 億美元的 APA 訂單，具體取決於更新的變體製造和監管批准。我們希望在 24 和 25 年交付剩餘的 APA。

In EU, we previously did not anticipate new sales during the first quarter due to the emerging seasonality of COVID vaccines. However, we accelerated our planned shipments and delivered doses committed under our existing APA during the first quarter to ensure our customers maintain supply in market. We expect to deliver the remaining 20 million doses of committed doses under our APA in the EU in 2023.

在歐盟，由於 COVID 疫苗的季節性出現，我們之前預計第一季度不會有新的銷售。但是，我們在第一季度加快了根據現有 APA 承諾的計劃發貨和交付劑量，以確保我們的客戶維持市場供應。我們預計將在 2023 年根據我們的 APA 在歐盟交付剩餘的 2000 萬劑承諾劑量。

In both Europe and APAC, Asia Pacific, we continue to service these customers through our existing APAs. At the same time, our commercial teams are engaged with key decision-makers at both the regional and local levels to prepare for the transition to tender and private markets in '24 and '25. We are confident in our product benefits and policy support to capture market share as an important protein-based option.

在歐洲和亞太地區，我們繼續通過現有的 APA 為這些客戶提供服務。與此同時，我們的商業團隊與區域和地方層面的關鍵決策者接洽，為 24 世紀和 25 世紀向招標和私人市場的過渡做準備。我們對我們的產品優勢和政策支持充滿信心，可以作為一種重要的基於蛋白質的選擇來佔領市場份額。

Importantly, across all our priority markets, we are engaged with policymaking bodies to advance policy recommendations for Nuvaxovid, which will be critical to enabling broad market access and capturing market share during the upcoming fall season.

重要的是，在我們所有的優先市場中，我們與決策機構合作，為 Nuvaxovid 提出政策建議，這對於在即將到來的秋季期間實現廣泛的市場准入和占領市場份額至關重要。

Finally, as John discussed earlier, our top organizational priority remains delivering a competitive product for the upcoming 2023 fall vaccination season. We are transitioning to a smaller dose presentation, which will be important to further differentiate our vaccine in market. This includes in the U.S., where our product will be available in single-dose trials. Both variant strain update and single-dose presentation are key product attributes that we believe will contribute to a strong market acceptance for our adjuvanted protein-based vaccine.

最後，正如 John 之前討論的那樣，我們的首要組織優先事項仍然是為即將到來的 2023 年秋季疫苗接種季節提供有競爭力的產品。我們正在過渡到更小的劑量呈現，這對於進一步區分我們的疫苗在市場上非常重要。這包括在美國，我們的產品將在美國進行單劑量試驗。變異菌株更新和單劑量展示都是關鍵的產品屬性，我們相信這將有助於我們的佐劑蛋白疫苗獲得強大的市場接受度。

Market research tells us that there is a demand for a non-mRNA COVID vaccine. When we asked health care providers in the U.S. for their preference, they indicated an approximately 31% preference share for our vaccine. This tells us that there is significant market share available to us as we are working towards an unrestricted policy recommendation for the fall season.

市場研究告訴我們，存在對非 mRNA COVID 疫苗的需求。當我們詢問美國的醫療保健提供者他們的偏好時，他們表示對我們疫苗的偏好份額約為 31%。這告訴我們，在我們努力為秋季制定不受限制的政策建議時，我們可以獲得很大的市場份額。

And as Filip outlined today, we advanced our variant stream development ahead of regulatory guidance on strain selection for the fall season. In the coming months, we will remain an ongoing dialogue with our customers and commercial stakeholders as we seek to ensure our vaccine is aligned with market needs and competitively positioned in the portfolio of COVID vaccines.

正如 Filip 今天概述的那樣，我們在秋季菌株選擇的監管指南之前推進了我們的變異流開發。在接下來的幾個月裡，我們將繼續與我們的客戶和商業利益相關者進行對話，以確保我們的疫苗符合市場需求並在 COVID 疫苗組合中處於競爭地位。

With that, I'll hand it over to Jim Kelly to discuss our financial results.

有了這個，我會把它交給吉姆凱利來討論我們的財務結果。

Thank you, John. Please turn to Slide 22. This morning, we announced our financial results for the first quarter of 2023. Details of our results can be found in our press release issued today and our 10-Q filing. I'll begin by providing an overview of our first quarter 2023 results and progress to date on our liability management. Then I'll provide more details regarding the global restructuring and cost-reduction initiative announced today. Finally, I will share financial guidance for the full year 2023.

謝謝你，約翰。請轉到幻燈片 22。今天上午，我們公佈了 2023 年第一季度的財務業績。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。首先，我將概述我們 2023 年第一季度的業績以及迄今為止在負債管理方面取得的進展。然後我將提供有關今天宣布的全球重組和成本削減計劃的更多細節。最後，我將分享 2023 年全年的財務指導。

Please turn to Slide 23. For the first quarter of 2023, we recorded combined R&D and SG&A expenses of $360 million. This reflects a $120 million or a 25% decrease compared to the first quarter of 2022 and a $60 million or 14% increase compared to the fourth quarter of 2022. This improvement represents the initial impact of our cost-reduction initiative, putting us on a path towards a significantly lower-cost structure as we transition Novavax' size and scope to align with the COVID opportunity.

請轉到幻燈片 23。2023 年第一季度，我們記錄的研發和 SG&A 合併支出為 3.6 億美元。這反映出與 2022 年第一季度相比減少了 1.2 億美元或 25%，與 2022 年第四季度相比增加了 6000 萬美元或 14%。這一改進代表了我們降低成本計劃的初步影響，使我們處於隨著我們將 Novavax 的規模和範圍轉變為與 COVID 機會保持一致，我們將朝著成本顯著降低的結構邁進。

We recorded $81 million in total revenue for the first quarter of 2023, which is consistent with an emerging seasonal demand pattern for COVID vaccines. Importantly, we reduced our outstanding current liabilities by $541 million, including funding the maturity of the $325 million convertible debt. And finally, we ended the quarter with $637 million in cash compared to $1.3 billion at the end of 2022.

我們在 2023 年第一季度的總收入為 8100 萬美元，這與新出現的 COVID 疫苗季節性需求模式一致。重要的是，我們將未償流動負債減少了 5.41 億美元，包括為到期的 3.25 億美元可轉換債券提供資金。最後，我們在本季度結束時擁有 6.37 億美元現金，而 2022 年底為 13 億美元。

Please turn to Slide 24. Beginning with revenue, we recorded $81 million in total revenue for the first quarter of 2023 compared to $704 million in the first quarter of 2022. Of note, you will see we recorded a net $7 million reversal of product sales in the first quarter of 2023. This relates to a $65 million credit that resulted from a single lot sold to the Australian government that upon a preplanned 6 months stability testing was found to have fallen below the defined specifications and therefore, was removed from the market. This credit will be applied against the future sale of doses to this customer.

請轉到幻燈片 24。從收入開始，我們在 2023 年第一季度的總收入為 8100 萬美元，而 2022 年第一季度為 7.04 億美元。請注意，您會看到我們記錄了 700 萬美元的產品銷售額淨逆轉2023 年第一季度。這涉及 6500 萬美元的信貸，該信貸來自向澳大利亞政府出售的一批貨物，在預先計劃的 6 個月穩定性測試中發現其低於定義的規格，因此被從市場上移除.此信用額度將用於抵消未來向該客戶銷售的劑量。

Our cost of sales for the first quarter of 2023 were $34 million compared to $15 million in the first quarter of 2022. This includes $20 million related to excess, obsolete or expired inventory and losses on firm purchase commitments. Research and development expenses for the first quarter of 2023 were $247 million compared to $383 million for the first quarter of 2022. The decrease was primarily due to a reduction in clinical and manufacturing spend.

我們 2023 年第一季度的銷售成本為 3400 萬美元，而 2022 年第一季度為 1500 萬美元。這包括與過剩、過時或過期庫存相關的 2000 萬美元，以及堅定採購承諾的損失。 2023 年第一季度的研發費用為 2.47 億美元，而 2022 年第一季度為 3.83 億美元。減少的主要原因是臨床和製造支出的減少。

Selling, general and administrative expenses for the first quarter of 2023 were $113 million compared to $96 million in the first quarter of 2022. The increase is related to expansion of our commercial sales operations in Europe and commercial investment in preparation for the full 2023 vaccination campaign, partially offset by certain cost containment measures to reduce our operating spend. For the first quarter of 2023, we recorded a net loss of $294 million compared to net income of $203 million in the first quarter of 2022, again reflecting the emerging seasonality of our business.

2023 年第一季度的銷售、一般和行政費用為 1.13 億美元，而 2022 年第一季度為 9600 萬美元。這一增長與我們在歐洲的商業銷售業務擴張以及為準備 2023 年全面疫苗接種活動而進行的商業投資有關，部分被某些成本控制措施所抵消，以減少我們的運營支出。 2023 年第一季度，我們錄得淨虧損 2.94 億美元，而 2022 年第一季度的淨收入為 2.03 億美元，這再次反映了我們業務的新季節性。

Please turn to Slide 25. In addition to making great strides to reduce the rate of spend during the first quarter of 2023, we also made significant progress to reduce our outstanding current liabilities from $2.5 billion to $1.9 billion. The $541 million decrease, including funding of the maturity of the $325 million convertible debt in January of 2023 and a $190 million reduction to payables. During April 2023, we addressed additional liabilities totaling $140 million.

請轉到幻燈片 25。除了在 2023 年第一季度大幅降低支出率外，我們還在將未償流動負債從 25 億美元減少到 19 億美元方面取得了重大進展。減少 5.41 億美元，包括為 2023 年 1 月到期的 3.25 億美元可轉換債券提供資金，以及應付賬款減少 1.9 億美元。 2023 年 4 月，我們解決了總計 1.4 億美元的額外負債。

Supportive of funding this April activity is a $100 million payment to Novavax secured for the second quarter of 2023 related to a renegotiated EPA that I will describe in more detail shortly. As of March 31, 2023, the $858 million of their current liabilities balance includes approximately $700 million related to the ongoing GAVI arbitration and $113 million related to a 2023 U.K. APA payment. Eliminating the more significant near-term liabilities is a key component of our objectives this year and combined with our significant cost-reduction initiative is intended to strengthen and stabilize our cash flow position as we seek to position Novavax for future growth.

為今年 4 月的活動提供資金支持的是在 2023 年第二季度向 Novavax 支付 1 億美元，這與重新談判的 EPA 有關，我將在稍後詳細介紹。截至 2023 年 3 月 31 日，其流動負債餘額的 8.58 億美元包括與正在進行的 GAVI 仲裁相關的約 7 億美元和與 2023 年英國 APA 付款相關的 1.13 億美元。消除更重要的近期負債是我們今年目標的一個關鍵組成部分，結合我們重大的成本削減計劃，旨在加強和穩定我們的現金流狀況，因為我們尋求為 Novavax 的未來增長定位。

Please turn to Slide 26. Today, we announced that we are implementing a global restructuring and cost-reduction initiative, which will significantly reduce our expenses while retaining the capabilities we need to drive results and build future value. When fully implemented, we expect these actions will reduce our combined R&D and SG&A expenses for 2024 to below $1 billion, reflecting an approximately 40% to 50% decrease when compared to 2022.

請轉到幻燈片 26。今天，我們宣布我們正在實施一項全球重組和成本削減計劃，這將顯著減少我們的開支，同時保留我們推動成果和創造未來價值所需的能力。全面實施後，我們預計這些行動將使我們 2024 年的研發和 SG&A 綜合支出減少至 10 億美元以下，與 2022 年相比減少約 40% 至 50%。

For 2023, we expect to realize about half of that amount or 20% to 25% reduction as compared to 2022 due to timing, local laws and regulations and other factors. For the full year 2023, we expect combined R&D and SG&A expenses to be between $1.3 billion and $1.4 billion as adjusted to exclude onetime restructuring costs. This global restructuring cost-reduction initiative is targeted to result in a more focused investment in our COVID program, a reduction in our pipeline spending, the continued rationalization of our manufacturing network and approximately 25% reduction to our global workforce, of which 80% of those impacted are full-time employees, as well as a consolidation of facilities and infrastructure. We believe these decisive actions were necessary as we establish a path forward towards long-term financial health and align Novavax to the opportunity ahead.

對於 2023 年，由於時間、當地法律法規和其他因素，我們預計與 2022 年相比將實現該金額的一半左右或減少 20% 至 25%。對於 2023 年全年，我們預計經調整以排除一次性重組成本後，研發和 SG&A 的合併支出將在 13 億美元至 14 億美元之間。這一全球重組成本削減計劃旨在使我們的 COVID 計劃更加集中投資，減少我們的管道支出，繼續使我們的製造網絡合理化，並減少我們全球勞動力的大約 25%，其中 80%受影響的是全職員工，以及設施和基礎設施的整合。我們認為，這些果斷行動是必要的，因為我們建立了通往長期財務健康的道路，並使 Novavax 與未來的機遇保持一致。

Please turn to Slide 27. For the full year 2023, we expect to achieve total revenue of between $1.4 billion and $1.6 billion from a combination of grant revenue and product sales in Nuvaxovid. Our projected product sales includes approximately $800 million in APA orders secured for 2023 based on committed delivery schedules and currently uncontracted U.S. market sales. Each subject to updated variant manufacturing and regulatory approvals.

請轉到幻燈片 27。對於 2023 年全年，我們預計 Nuvaxovid 的贈款收入和產品銷售的總收入將在 14 億美元至 16 億美元之間。我們預計的產品銷售額包括約 8 億美元的 APA 訂單，這些訂單是根據承諾的交貨時間表和目前未簽訂合同的美國市場銷售額在 2023 年獲得的。每個都要經過更新的變體製造和監管批准。

For expenses, we expect to lower our combined R&D and SG&A expenses for the full year 2023 to between $1.3 billion and $1.4 billion as adjusted to exclude onetime restructuring costs, which at midpoint is approximately $375 million lower than 2022. This expects guidance reflects our COVID stand-alone business cost structure and excludes potential costs associated with a Phase III flu kick program. We plan to evaluate our positive Phase II flu kick results announced today to frame our options to advance and finance this program via strategic collaborations and/or available finance alternatives.

對於支出，我們預計將 2023 年全年的研發和 SG&A 合併支出降低至 13 億美元至 14 億美元，經調整以排除一次性重組成本，中點比 2022 年低約 3.75 億美元。這預計指導反映了我們的 COVID獨立的業務成本結構，不包括與 III 期流感踢球計劃相關的潛在成本。我們計劃評估我們今天宣布的積極的 II 期流感踢球結果，以製定我們的選擇方案，以通過戰略合作和/或可用的融資方案推進和資助該計劃。

Our ongoing 2023 cash management and resulting cash flow are important to help enable the delivery of our vaccine for the fall 2023 season. In the combined second and third quarters of 2023, we expect to receive cash inflows of over $500 million from product sales of our prototype Wuhan vaccine, government grants and $100 million payment secured for the second quarter 2023 related to a renegotiated APA. This $100 million payment is excluded from full year 2023 sales guidance and we plan to continue to negotiate for additional 2023 payments from our committed APA book of business as we explore a full range of non-dilutive and dilutive funding alternatives to advance our business. If successful in achieving the full year 2023 guidance outlined today, we believe this will support the funding of our operations for the next 12 months.

我們正在進行的 2023 年現金管理和由此產生的現金流對於幫助我們在 2023 年秋季交付疫苗非常重要。在 2023 年第二季度和第三季度，我們預計將從武漢疫苗原型產品銷售、政府補助和與重新談判的 APA 相關的 2023 年第二季度獲得的 1 億美元付款中獲得超過 5 億美元的現金流入。這筆 1 億美元的付款不包括在 2023 年全年的銷售指導中，我們計劃繼續談判從我們承諾的 APA 業務簿中獲得額外的 2023 年付款，因為我們探索了全方位的非稀釋性和稀釋性資金替代方案來推進我們的業務。如果成功實現今天概述的 2023 年全年指導，我們相信這將支持我們未來 12 個月的運營資金。

In our 10-Q filing, you will see that we have provided an update on our going concern disclosure, which we first provided in our 10-K filing in February. Specifically that this forecast continues to be subject to significant uncertainty related to revenue for the next 12 months, funding from the U.S. government and pending arbitration.

在我們的 10-Q 文件中，您會看到我們提供了持續經營披露的最新信息，這是我們在 2 月份的 10-K 文件中首次提供的。具體而言，該預測將繼續受到與未來 12 個月的收入、美國政府的資助和未決仲裁相關的重大不確定性的影響。

With that said, I'd like to turn the call back to John for some closing remarks.

話雖如此，我想把電話轉回給約翰，讓他做一些結束語。

Thank you, Jim. Please turn to Slide 28. I'd like to underscore that as I've learned more about our organization and our people in recent months that I've seen a passion across our company to advance our mission and deliver innovative vaccines to improve global public health. As the team demonstrated today, we've taken decisive actions on the priorities we outlined in our February call, including our intent to advance our updated vaccine for the fall campaign, strategically manage our investments and dramatically reduce our spend and work to drive additional value from our pipeline and technology platforms. We continue to operate with this focus on fiscal responsibility in parallel with making the investments needed to achieve our 3 key priorities.

謝謝你，吉姆。請轉到幻燈片 28。我想強調的是，隨著最近幾個月我對我們的組織和我們的員工有了更多了解，我看到我們公司上下都對推進我們的使命和提供創新疫苗以改善全球公眾的熱情健康。正如該團隊今天所展示的那樣，我們已經就我們在 2 月份的電話會議中概述的優先事項採取了果斷行動，包括我們打算為秋季活動推進更新的疫苗、戰略性地管理我們的投資並大幅減少我們的支出和努力推動附加價值來自我們的管道和技術平台。我們繼續將重點放在財政責任上，同時進行必要的投資以實現我們的 3 個關鍵優先事項。

The reductions to our workforce that we announced today were difficult decision, but we felt they were a necessary one to put the company on a better pathway towards financial strength and sustainability. Let me say that we deeply appreciate the contributions made by those employees who have been adversely impacted today, and we will appropriately support them as they make the transition to new opportunities.

我們今天宣布的裁員是一個艱難的決定，但我們認為這是使公司走上更好的財務實力和可持續發展道路的必要決定。我要說的是，我們非常感謝那些今天受到不利影響的員工所做的貢獻，我們將在他們過渡到新的機遇時給予適當的支持。

The positive Phase II data we announced today further reinforces our belief in the value of our recombinant protein nanoparticle plus Matrix-M adjuvanted technology platform at Novavax. Our prior positive Phase III results for both our COVID and flu vaccines, plus this new Phase II data provide additional confidence for us to move towards Phase III for one or more of these products potentially in the future. It is our intention to leverage this technology to build a robust portfolio of vaccines to further support our mission of positively impacting global health.

我們今天宣布的積極的 II 期數據進一步強化了我們對 Novavax 重組蛋白納米顆粒加 Matrix-M 佐劑技術平台價值的信念。我們先前的 COVID 和流感疫苗的 III 期陽性結果，加上這一新的 II 期數據，為我們在未來可能向這些產品中的一種或多種進入 III 期提供了額外的信心。我們打算利用這項技術建立強大的疫苗組合，以進一步支持我們積極影響全球健康的使命。

As we continue to execute on our strategy and key priorities, we're confident that we're taking the right steps with the goal of positioning Novavax for success and delivering positive results for our stakeholders in '23 and over the long term.

隨著我們繼續執行我們的戰略和關鍵優先事項，我們相信我們正在採取正確的步驟，目標是將 Novavax 定位為成功，並在 23 世紀和長期內為我們的利益相關者帶來積極的結果。

And with that, we will now take your questions.

有了這個，我們現在將回答您的問題。

(Operator Instructions) Our first question comes from Roger Song with Jefferies.

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

A couple from me. First one is regarding this -- the revenue guidance since you provide this revenue guidance in ex-U.S. $800 million APA. I just wonder get some additional comments related to how confident you are about this APA given the recent EU they have some proposed deal with your competitor?

我的一對。第一個是關於這個——收入指導，因為你在美國以外提供了這個收入指導。 8 億美元的 APA。鑑於最近歐盟與您的競爭對手提出了一些交易建議，我只是想知道您對此 APA 的信心如何？

And in terms of the breakdown within the $800 million, can you provide additional color around the timing, geography, maybe last portion -- last part of the question is the -- related to the remaining APA. Last quarter, you said you have $2.1 billion in total since you are doing some renegotiation, just curious what's left for your APA to be delivered in 2024 and 2025?

就 8 億美元的細分而言，您能否提供有關時間、地理位置的其他顏色，也許是最後一部分——問題的最後一部分——與剩餘的 APA 相關。上個季度，你說你有 21 億美元，因為你正在進行一些重新談判，只是好奇你的 APA 還剩下什麼要在 2024 年和 2025 年交付？

Thank you, Roger. Appreciate the question. John Trizzino, would you like to take that one?

謝謝你，羅傑。感謝這個問題。 John Trizzino，你想要那個嗎？

Sure. Roger, there's a couple of components to your question. Let me try to parse them out. First of all, the $2.1 billion is still a true kind of adherence to the original value of all those contracts, and we expect that and to date, still have confidence in that value. Now that's going to be -- some of that is going to fall into '24 and '25, the $800 million for '23 are locked in orders, committed orders allocated to be shipped during various quarters of the balance of this year. So confident in the $800 million.

當然。羅傑，你的問題有幾個組成部分。讓我試著把它們解析出來。首先，21 億美元仍然是對所有這些合同原始價值的真正遵守，我們預計並且迄今為止，仍然對該價值充滿信心。現在這將是——其中一些將落入 24 和 25 年，23 年的 8 億美元被鎖定在訂單中，承諾的訂單分配到今年餘下的各個季度發貨。對8億美元充滿信心。

That settlement that's happening in Europe with Pfizer, I think there are still some details to be determined there, but that will not affect revenue generation during the APA period. There are possible implications to that in the future when we go to tender and private market selling, but have already had multiple conversations with the European Commission, Director General and his staff about the need for a protein-based vaccine in a vaccine portfolio. So critical, there's an awareness and a need to make sure that our vaccine is available. The contracts and APAs support the $2.1 billion and the $800 million is locked in delivery schedules for 2023.

與輝瑞公司在歐洲達成的和解協議，我認為那裡仍有一些細節需要確定，但這不會影響 APA 期間的創收。當我們在未來進行招標和私人市場銷售時，這可能會產生影響，但已經與歐盟委員會、總幹事及其工作人員就疫苗組合中對基於蛋白質的疫苗的需求進行了多次對話。如此重要，人們意識到並需要確保我們的疫苗可用。合同和 APA 支持 21 億美元，而 8 億美元鎖定在 2023 年的交付時間表中。

And Roger, you had a question about the allocation of that $2.1 billion relative to 2023 versus future periods. So the items we discussed today were the $800 million secured APAs for delivery. And I also mentioned a $100 million payment which came from a renegotiated APA that has been secured for the second quarter. So that gets you to $900 million total of the $2.1 billion. That leaves an additional $1.2 billion outstanding. And as I mentioned in our remarks, that these are available for delivery. They're, of course, committed and we are going to actively seek to renegotiate some of these APAs as a mechanism for nondilutive financing and certainly more on that in future calls as we move forward.

羅傑，你有一個關於 21 億美元相對於 2023 年與未來時期的分配問題。因此，我們今天討論的項目是 8 億美元的有擔保 APA 交付。我還提到了一筆 1 億美元的付款，該付款來自第二季度已確定的重新談判的 APA。這樣一來，您就可以獲得 21 億美元中的 9 億美元。這還剩下 12 億美元未償還。正如我在評論中提到的那樣，這些都可以交付。當然，他們是承諾的，我們將積極尋求重新談判其中一些 APA 作為非稀釋性融資的機制，並且在我們前進的過程中肯定會在未來的電話中更多地討論這一點。

Excellent. That's very helpful. And then so moving on to the U.S. market, understanding you're doing the inventory view for the strain change and you will have the midyear data to potentially support a strain change, just curious what additional data you needed once the VRBPAC meeting June 15, decided which strain change to select what additional data you need to be able to deliver in the U.S. market for the fall? And related to that is for the U.S. market, it seems that's also part of the revenue guidance outside of the $800 million, how much you are building for the U.S. market or it's kind of upside and you have a range of the revenue guidance is maybe towards the upside of the revenue guidance.

出色的。這很有幫助。然後轉向美國市場，了解您正在為應變變化做庫存視圖，並且您將擁有年中數據可能支持應變變化，只是好奇在 6 月 15 日 VRBPAC 會議後您需要哪些額外數據，決定了哪種壓力變化來選擇您需要在秋季在美國市場提供哪些額外數據？與此相關的是美國市場，似乎這也是 8 億美元之外的收入指導的一部分，你正在為美國市場建設多少或者它有點上行，你有一系列的收入指導可能是朝著收入指導的上行方向發展。

Filip, would you like to take the first part of Roger's question.

菲利普，你願意回答羅傑問題的第一部分嗎？

Sure. I'll at least take the first part or the first part of Roger's question, and that's really the main thing we're waiting for is the strain composition selection, right? The study that we're conducting will read out, as you mentioned, and we've done this before and we're successful with that study. So we don't see why it should be any different. The additional details that need to be part of that file are, in fact, manufacturing details and it includes stability of the strain that elected, et cetera. And that's all part of the regulatory time line that we've developed, and we've discussed multiple times with the global regulatory agencies. So they understand the kinds of barriers we have to put in the vaccine in the market, and we're pretty confident about that right now.

當然。我至少會回答 Roger 問題的第一部分或第一部分，我們真正等待的主要是菌株成分選擇，對嗎？正如您提到的，我們正在進行的研究將被宣讀出來，我們之前已經這樣做過，並且我們在該研究中取得了成功。所以我們不明白為什麼它應該有任何不同。實際上，需要成為該文件一部分的其他詳細信息是製造詳細信息，它包括所選菌株的穩定性等。這就是我們制定的監管時間表的全部內容，我們已經與全球監管機構進行了多次討論。所以他們了解我們必須在疫苗市場上設置的各種障礙，我們現在對此非常有信心。

Thank you, Filip. And Jim, maybe you could take the second part of Roger's question.

謝謝你，菲利普。吉姆，也許你可以回答羅傑問題的第二部分。

Certainly. And thanks for asking because gives me the opportunity to walk you through in a little more detail our revenue guidance. So we've guided to total revenue of $1.4 billion to $1.6 billion, of course, midpoint at $1.5 billion. And that guidance is inclusive of both our product sales and grants, and I'll begin with grants. Grants at the midpoint is $350 million range of $340 million to $360 million. As folks know, we've been operating with the U.S. government under Operation Warp Speed to fund much of our clinical activity, and that continues through this year and is the basis for grants revenue.

當然。感謝您的提問，因為讓我有機會向您詳細介紹我們的收入指南。因此，我們指導的總收入為 14 億美元至 16 億美元，當然，中點為 15 億美元。該指導包括我們的產品銷售和贈款，我將從贈款開始。中點撥款為 3.5 億美元，範圍為 3.4 億美元至 3.6 億美元。正如人們所知，我們一直在與美國政府合作開展“曲速行動”，為我們的大部分臨床活動提供資金，這將持續到今年，並且是撥款收入的基礎。

For product sales, our guidance is $1.06 billion to $1.24 billion, and that's inclusive of both the $800 million we spoke of just a moment ago, which is for secured APA delivery. And if you subtract that, it results in U.S. at $260 million to $440 million or $350 million at the midpoint. So hopefully, that's helpful.

對於產品銷售額，我們的指導價為 10.6 億美元至 12.4 億美元，其中包括我們剛才談到的用於安全 APA 交付的 8 億美元。如果你減去它，它會導緻美國在中點為 2.6 億至 4.4 億美元或 3.5 億美元。希望這會有所幫助。

Thank you, Jim.

謝謝你，吉姆。

No, that's helpful. Okay. I understand basically the balance of the $800 million outside of your product sales, that's the U.S. market. Got you. Okay. Great. Bear me for the last one question. So related to your -- the COVID flu combination therapy, data looks pretty robust. But noticing, I think, John, you mentioned you are moving towards the partnership, maybe some strategic collaboration for -- to move forward this program.

不，那很有幫助。好的。我基本上了解您產品銷售之外的 8 億美元餘額，即美國市場。明白了好的。偉大的。容我回答最後一個問題。與您的 COVID 流感聯合療法相關，數據看起來非常可靠。但是請注意，我認為，約翰，你提到你正在建立夥伴關係，也許是一些戰略合作 - 以推進這個計劃。

Just maybe elaborate on your plan there. What will be the next immediate next step for the combo and some other kind of stand-alone vaccine a little bit different from what you already have, do you need a Phase IIb efficacy study before you move into the Phase III? Just a little bit more detail, that would be appreciated.

也許在那裡詳細說明你的計劃。聯合疫苗和其他一些與現有疫苗略有不同的獨立疫苗的下一步是什麼，在進入 III 期之前是否需要進行 IIb 期療效研究？再詳細一點，將不勝感激。

Thank you for your question, Roger. Let me answer it this way, and I can let Filip address the Phase IIb question, et cetera. As we noted in our call and in our prepared comments, our focus this year is on our 3 priorities, our top priority at Novavax is launching our updated Nuvaxovid in line with regulatory authority requirements for this fall season and a competitive product profile and on time for our customers as the fall season emerges. That's our #1 goal. In parallel with that is reducing our cost and resizing the company and addressing our near term and current liabilities aggressively. I think we've demonstrated some decisive actions that the leadership team and I have taken with the support of our Board in that direction very clearly now in the first quarter.

謝謝你的問題，羅傑。讓我這樣回答，我可以讓 Filip 解決 IIb 階段的問題，等等。正如我們在電話會議和準備好的評論中指出的那樣，我們今年的重點是我們的 3 個優先事項，我們在 Novavax 的首要任務是推出我們更新的 Nuvaxovid，以符合今年秋季的監管機構要求，並按時推出具有競爭力的產品概況隨著秋季的到來，為我們的客戶提供。這是我們的第一目標。與此同時，我們正在降低成本，調整公司規模，積極解決我們的短期和流動負債問題。我認為我們已經在第一季度非常清楚地展示了領導團隊和我在董事會的支持下朝這個方向採取的一些果斷行動。

We're excited and encouraged about the data. This is a Phase II top line results. And if we continue to execute on our plan successfully this year, we should be able to position Novavax in a stronger place from a financial perspective. So we can have options next year on how to bring forward these unique and interesting assets that are in development right now. And we'll continue to learn from the data in the coming months and have discussions with regulatory authorities and how to best bring these forward.

我們對這些數據感到興奮和鼓舞。這是第二階段的頂線結果。如果我們今年繼續成功執行我們的計劃，我們應該能夠從財務角度將 Novavax 置於更強大的位置。因此，明年我們可以選擇如何推出目前正在開發的這些獨特而有趣的資產。我們將在未來幾個月繼續從數據中學習，並與監管機構討論如何最好地推進這些工作。

Filip, would you like to add additional commentary on Roger's question around what type of study may be next for these assets?

菲利普，你想對羅傑關於這些資產接下來可能進行哪種類型的研究的問題添加額外的評論嗎？

Yes. I mean a lot of that really depends on regulatory guidance. We would clearly not go into pivotal study without very firm regulatory guidance. And that may well depend on what we see in the rest of the data. Additionally, if we do move forward with a strategic partner, that ultimate design and time line will be determined in collaboration with such a partner. Now what we are planning on doing right now is doing a Phase II study with our high-dose COVID product. And that's going to be done with the XBB 1.5. format. I mentioned that earlier. And the idea there is going to be to really explore the optimal formulation, including the antigen as well as adjuvant dose levels to optimize immune response.

是的。我的意思是，其中很多確實取決於監管指導。如果沒有非常嚴格的監管指導，我們顯然不會進行關鍵研究。這很可能取決於我們在其餘數據中看到的內容。此外，如果我們確實與戰略合作夥伴一起推進，最終設計和時間表將與這樣的合作夥伴合作確定。現在我們計劃做的是用我們的高劑量 COVID 產品進行 II 期研究。這將通過 XBB 1.5 來完成。格式。我之前提到過。並且這個想法將是真正探索最佳配方，包括抗原以及佐劑劑量水平以優化免疫反應。

You followed us for a long time. So you know that we did our initial dose ranging in naive at the very beginning of the pandemic, and we saw there was no difference when you changed the antigen dose level. But we're in a different place now where people are heavily primed, and we are seeing evidence that as we increase the dose level in these primed individuals, we do get a better immune response. So we're looking to develop a high-dose formulation to be for annual vaccination, primarily in the elderly market, similar to what has been done in influenza.

你跟著我們很久了。所以你知道我們在大流行開始時天真地做了我們的初始劑量範圍，當你改變抗原劑量水平時我們看到沒有差異。但我們現在處在一個不同的地方，那裡的人們已經高度準備好了，而且我們看到的證據表明，當我們增加這些準備好的個體的劑量水平時，我們確實會得到更好的免疫反應。因此，我們正在尋求開發一種高劑量配方，用於每年一次的疫苗接種，主要針對老年人市場，類似於流感疫苗的做法。

Your next question comes from Eric Joseph with JPMorgan.

你的下一個問題來自摩根大通的埃里克約瑟夫。

So I just wanted to come back on launch preparedness for the fall season and just -- and kind of get a sense of where your confidence comes from being able to launch ahead of a BLA approval? And I guess it's currently planned proceeding under EUA. Can you talk about whether there are any amendments or expansions of the existing EUA that are necessary to facilitate a commercial launch in the U.S.?

所以我只是想回到秋季的發布準備工作，並且只是 - 並且有點了解您能夠在 BLA 批准之前啟動的信心來自哪裡？我猜它目前計劃在 EUA 下進行。您能否談談現有 EUA 是否有任何必要的修改或擴展，以促進在美國的商業發布？

John Trizzino, would you like to take that question from Eric, please?

John Trizzino，你願意接受 Eric 的問題嗎？

Yes. So we have been in constant coordination with the FDA on where we are today under emergency use authorization as well as submission of the BLA and the timing of the BLA submission and where that leaves us under emergency use authorization. So we have emergency use authorization for the product that is today approved and labeled by the FDA and around the globe. We will need an additional emergency use authorization similar to all of the other manufacturers for the new strain and the new format, which is yet to be decided.

是的。因此，我們一直在與 FDA 就我們今天在緊急使用授權下的位置以及 BLA 的提交和 BLA 提交的時間以及我們在緊急使用授權下的位置進行持續協調。因此，我們擁有該產品的緊急使用授權，該產品如今已獲得 FDA 和全球範圍內的批准和標記。對於新菌株和新格式，我們將需要與所有其他製造商類似的額外緊急使用授權，但尚未確定。

Based upon those conversations with the FDA, it is our expectation, and specifically based upon conversations we've had with them, that we will be operating under an emergency use authorization without restriction. So I think that really says all that we need to know at this point. And that means that all of the activities that I talked about during our planned remarks, with access to pharmacies, access to all health care providers, access to distributors will be unrestricted.

根據與 FDA 的對話，我們的期望是，特別是根據我們與他們的對話，我們將在不受限制的緊急使用授權下運營。所以我認為這確實說明了我們目前需要知道的所有內容。這意味著我在計劃的發言中談到的所有活動，包括進入藥店、進入所有醫療保健提供者、進入分銷商都將不受限制。

Okay. And maybe just a follow-up on the manufacturing side. Can you just talk about sort of the manufacturing lead time after appropriate strain selection, it sounds like in June, I guess what -- ultimately, what those quantities do you think could be supplied or market-ready at launch? And also a little more detail on sort of where supply is being sourced from whether it's from serum or other facilities?

好的。也許只是製造方面的後續行動。你能談談在適當的應變選擇之後的製造提前期嗎，聽起來像是在 6 月，我猜是什麼——最終，你認為在發佈時可以供應或準備好這些數量是多少？還有更多關於供應來源的詳細信息，無論是來自血清還是其他設施？

Thank you, Eric. Right now, we're not disclosing specific quantities of our production plan in the public domain, but that's a very good question. And we've -- as we said on our prior call, we've changed the way we're working with FDA and the way we're working internally with our project teams to do everything we can to appropriately minimize the time it takes to be ready for the fall season, and that includes quite a nice shift in the dynamic with FDA. We've seen an excellent partnership from both FDA and global regulatory authorities who have expressed to us that they value a protein-based option in the marketplace for consumers around the globe.

謝謝你，埃里克。現在，我們不會在公共領域披露我們生產計劃的具體數量，但這是一個很好的問題。我們已經——正如我們在之前的電話會議上所說，我們已經改變了與 FDA 合作的方式，以及我們與項目團隊在內部合作的方式，盡一切努力適當地減少所需時間為秋季做好準備，這包括與 FDA 動態的相當大的轉變。我們已經看到 FDA 和全球監管機構建立了良好的合作夥伴關係，他們向我們表示，他們重視市場上面向全球消費者的基於蛋白質的選擇。

And we've made significant progress, as we said before, in bringing multiple strains forward and that's key because we're able to get the data, assess the data on which strains are becoming predominant and bring several streams forward. And Filip discussed that during his prepared remarks earlier, and we have some slides on that. So we feel that we're currently on track to be ready despite potentially taking protein-based vaccines a little bit longer from the very beginning of go to get finished. We've been taking steps right now already to prime that pump and to be ready to bring the vaccine forward.

正如我們之前所說，我們在推進多種菌株方面取得了重大進展，這很關鍵，因為我們能夠獲取數據，評估哪些菌株變得占主導地位的數據，並推動幾個方面的進展。菲利普在他之前準備好的發言中討論了這一點，我們有一些幻燈片。因此，我們認為我們目前正在準備就緒，儘管從一開始就可能需要更長的時間才能完成基於蛋白質的疫苗。我們現在已經在採取措施啟動泵，並準備好推出疫苗。

John Trizzino, would you like to add any color or comment to that? And Rick Crowley as well, who leads our manufacturing is here as well.

John Trizzino，您想對此添加任何顏色或評論嗎？領導我們製造的 Rick Crowley 也在這裡。

I think, John, that pretty well captures it. Of course, Eric, you can imagine that as we're anticipating revenue generation and product availability, we're thinking through exactly all of those time lines. And it's manufacturing time lines, fill finish, getting product to the right distribution centers making sure that the regulatory approvals are in place. So end to end, those time lines have been examined and scrutinized to make sure that we have product available at the start of the fall season.

我認為，約翰，這很好地抓住了它。當然，埃里克，你可以想像，當我們期待創收和產品可用性時，我們正在考慮所有這些時間線。它是製造時間線、填充完成、將產品運送到正確的配送中心以確保監管批准到位。因此，端到端，這些時間線已經過檢查和審查，以確保我們在秋季開始時有可用的產品。

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。

Appreciate the level of detail this morning. Including the progress on balance sheet and OpEx resizing, are you able to provide any granularity on how fiscal year '23 reductions will be split between R&D and SG&A? And in terms of workforce restructuring also 2023 versus 2024, any level of granularity there would be helpful. And then I have a couple of follow-ups.

感謝今天早上的詳細程度。包括資產負債表和 OpEx 規模調整的進展，您是否能夠提供關於如何在 R&D 和 SG&A 之間分配 23 財年削減的任何細節？就 2023 年與 2024 年的勞動力重組而言，任何粒度級別都會有所幫助。然後我有幾個後續行動。

Thank you, Mayank. Jim Kelly, would you like to take Mayank's question?

謝謝你，瑪雅克。 Jim Kelly，你願意回答 Mayank 的問題嗎？

Certainly. Mayank, as we announced this morning, I mean, we have a significant global restructuring and cost-saving initiatives that touches each corner of our organization, both functionally and geographically. That means that we will, among other things, focus on our core priority of delivering our vaccine this fall, so you're watching a sharpening of our investment on our COVID program.

當然。 Mayank，正如我們今天早上宣布的那樣，我的意思是，我們有一項重要的全球重組和成本節約計劃，涉及我們組織的每個角落，無論是在職能上還是在地理上。這意味著，除其他事項外，我們將在今年秋天專注於提供疫苗這一核心優先事項，因此您會看到我們對 COVID 計劃的投資有所增加。

The cost structure that we're describing today is the COVID stand-alone cost structure. I described in more detail that it did not include at this time, advancement of pipeline, including based on some of the great flu kick results we saw today. So when we look back to these reductions, again, it's a sharpening of our focus on the COVID business. It is a pausing of our pipeline. It includes a continued rationalization of our manufacturing network as we size it for the endemic opportunity. It also includes a 25% reduction in our total workforce, inclusive approximately of 80% of those impacted our full-time employees and then also a consolidation of facilities and infrastructure.

我們今天描述的成本結構是 COVID 獨立成本結構。我更詳細地描述了它目前不包括管道的改進，包括基於我們今天看到的一些很好的流感踢結果。因此，當我們再次回顧這些削減時，我們更加關注 COVID 業務。這是我們管道的暫停。它包括我們的製造網絡的持續合理化，因為我們會根據普遍存在的機會調整它。它還包括我們的員工總數減少 25%，其中包括約 80% 的受影響的全職員工，然後還整合了設施和基礎設施。

When you look at where this from '22 to '24 will hit in different aspects of R&D plus SG&A, it is primarily going to be in the R&D realm. And this is because as we continue to make investments in our commercial footprint to ensure success in the marketplace, in our priority markets of the U.S., Europe and select APAC, what we're seeking to do is further reduce our G&A and infrastructure to enable that investment. So watch us seek to hold steady as best possible SG&A. And then when you look at the reductions from '22 to '24, a significant amount will be reflective of those steps I just described. So hopefully, that's helpful.

當您查看從'22 到'24 將在研發和 SG&A 的不同方面產生影響時，它主要是在研發領域。這是因為隨著我們繼續對我們的商業足跡進行投資以確保在市場上取得成功，在我們的美國、歐洲和部分亞太地區的優先市場，我們正在尋求做的是進一步減少我們的 G&A 和基礎設施，以實現那個投資。因此，請注意我們尋求盡可能保持穩定的 SG&A。然後，當您查看從 22 年到 24 年的減少時，很大一部分將反映我剛才描述的那些步驟。希望這會有所幫助。

Yes, very helpful. On that topic, if you could comment also on the liabilities reduction program? Obviously, great updates on the par and U.K. government payment, but there are a number of other things in the works like GAVI, if you could provide any update on that, that would be helpful.

是的，很有幫助。關於這個話題，您能否也對負債削減計劃發表評論？顯然，在 par 和英國政府支付方面有很大的更新，但是還有很多其他的事情正在進行中，比如 GAVI，如果你能提供任何關於這方面的更新，那將會很有幫助。

Yes. Jim, do you want to just cover the liabilities question first?

是的。吉姆，你想先解決負債問題嗎？

Certainly. Beginning with the liabilities, we made significant progress this quarter, reducing our current liabilities by over $541 million. And you will see that one of the key components of that was funding the maturity of our convertible notes for $325 million, but also, you saw a significant reduction in our payables, approximately $190 million. So that's a part of a really important step for us to address, in some cases, onetime liabilities as we better put this company on a strong financial footing. So hopefully, that covers at least through 3/31, your question, but we also make sure we make folks aware of that. We addressed another $140 million in liabilities in April, including resolution of the par arbitration for $27 million. And then also, we did make that payment to the U.K. per our APA of $113 million and that related to the terms of the agreement that had previously been discussed.

當然。從負債開始，我們在本季度取得了重大進展，將我們的流動負債減少了超過 5.41 億美元。你會看到其中的一個關鍵組成部分是以 3.25 億美元為我們的可轉換票據的到期提供資金，而且你還看到我們的應付賬款大幅減少，約為 1.9 億美元。因此，這是我們解決（在某些情況下）一次性負債的一個非常重要的步驟的一部分，因為我們可以更好地使這家公司處於強大的財務基礎上。所以希望這至少涵蓋到 3/31，你的問題，但我們也確保我們讓人們意識到這一點。我們在 4 月份又處理了 1.4 億美元的債務，包括 2700 萬美元的平價仲裁決議。然後，我們確實根據我們的 1.13 億美元 APA 向英國支付了這筆款項，這與之前討論過的協議條款有關。

Now one of the things that is helpful here is I announced that we had secured a $100 million payment under a renegotiated APA. So that's incredibly helpful to help fund those liabilities. And I also described in our remarks that during Q2 and Q3, we expect inflows of cash flow of over $500 million. So it is the combination of liability management progress to date, our expectations around future cash flow into Q2 and Q3 that we find important to put us on the right footing towards being prepared for the fall vaccination season.

現在有幫助的一件事是我宣布我們已經根據重新談判的 APA 獲得了 1 億美元的付款。因此，這對於為這些負債提供資金非常有幫助。我還在我們的評論中描述，在第二季度和第三季度，我們預計現金流量將超過 5 億美元。因此，結合迄今為止的負債管理進展、我們對未來第二季度和第三季度現金流的預期，我們發現重要的是讓我們為秋季疫苗接種季節做好準備。

And then, Mayank, you did ask about GAVI. So look, there's obviously not much I can say related to the legal matters that the company is addressing. But what I can do is confirm that we're currently in the arbitration process with GAVI regarding this matter and to restate Novavax's position that we do not believe we owe the money that's in question. And obviously, we cannot predict the outcome of any arbitration. But what I can say is we'd like to put the matter behind us as soon as possible and that, frankly, were frustrated by the situation. And that's because we believe we share the same mission as GAVI to help improve global public health and to provide high-quality vaccines to people in low-income countries. And we're frustrated that the current matter is not yet resolved and has the potential of impeding our ability to fulfill this mission to the best of our capabilities.

然後，Mayank，你確實問到了 GAVI。所以看，關於公司正在處理的法律問題，我顯然不能說太多。但我能做的是確認我們目前正在與 GAVI 就此事進行仲裁，並重申 Novavax 的立場，即我們不認為我們欠有問題的錢。顯然，我們無法預測任何仲裁的結果。但我能說的是，我們希望盡快把這件事拋在腦後，坦率地說，我們對這種情況感到沮喪。這是因為我們相信我們與 GAVI 有著相同的使命，即幫助改善全球公共衛生並為低收入國家的人們提供高質量的疫苗。我們感到沮喪的是，目前的問題尚未解決，並且有可能阻礙我們盡最大努力完成這一使命的能力。

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

我們的問答環節到此結束。我想將會議轉回給 John Jacobs 作閉幕詞。

Just like to thank everyone for joining us today. We appreciate your time and your confidence in us. Thank you very much. Appreciate it.

就像感謝大家今天加入我們一樣。我們感謝您的時間和您對我們的信任。非常感謝。欣賞它。

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。