Novavax Inc (NVAX) 2024 Q2 法說會逐字稿

Good morning, and welcome to Novavax second-quarter 2024 financial results and operational highlights conference call.

早安，歡迎參加 Novavax 2024 年第二季財務表現與營運亮點電話會議。

(Operator Instructions).

（操作員說明）。

Please note, this event is being recorded.

請注意，此事件正在被記錄。

I would now like to turn the call over to your speaker today, Erika Schultz, Senior Director, Investor Relations.

我現在想將電話轉給今天的演講者、投資者關係高級總監 Erika Schultz。

Please go ahead.

請繼續。

Good morning, and thank you, all, for joining us today to discuss our second-quarter 2024 operational highlights and financial results.

早安，感謝大家今天加入我們討論我們 2024 年第二季的營運亮點和財務表現。

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.

目前，我們的網站 novavax.com 上發布了宣布我們結果的新聞稿，並且今天晚些時候將在我們的網站上提供本次電話會議的音訊檔案。

Please turn to slide 2.

請翻到投影片 2。

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; statements related to potential royalties and milestones; operating plans, objectives, and prospects; full-year 2024 financial guidance; the amount and impact of Novavax's cost reduction plans; its future financial or business performance conditions or strategies; its partnerships; anticipated timing and outcome of future regulatory filings and actions; and the ongoing development, marketing opportunities, manufacturing capacity, and future availability of our vaccine candidates; and key upcoming milestones.

在我們開始準備好的評論之前，我需要提醒您，本簡報包含前瞻性陳述，包括與 Novavax 未來相關的資訊；其關鍵策略重點；與潛在特許權使用費和里程碑相關的聲明；營運計劃、目標和前景； 2024 年全年財務指引； Novavax 成本削減計劃的金額和影響；其未來的財務或業務績效狀況或策略；其合作夥伴關係；未來監理備案和行動的預期時間和結果；以及我們候選疫苗的持續開發、行銷機會、生產能力和未來可用性；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.

本簡報中包含的每項前瞻性陳述均面臨風險和不確定性，可能導致實際結果與此類陳述中的預測有重大差異。

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, available at www.sec.gov and on our website at novavax.com. 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.

有關這些因素的更多資​​訊出現在我們今天早上發布的幻燈片中的“有關前瞻性陳述的注意事項”標題下，以及在我們提交的最新表格10-K 和隨後的表格10-Q 中的“風險因素」標題下。與美國證券交易委員會聯繫，請造訪 www.sec.gov 和我們的網站 novavax.com。本簡報中的前瞻性聲明僅代表截至本簡報原始日期的情況，我們不承擔更新或修改任何這些陳述的義務。

Please turn to slide 3.

請翻到幻燈片 3。

This presentation also includes references to a non-GAAP financial measure, which is forward-looking information for R&D and SG&A expense, as adjusted, for expense reimbursement from Sanofi under the Sanofi agreement.

本簡報也引用了非公認會計準則財務指標，該指標是賽諾菲根據賽諾菲協議報銷的研發和銷售、一般管理費用（經調整）的前瞻性資訊。

Please turn to slide 4.

請翻到幻燈片 4。

Joining me today is John Jacobs, our President and CEO, who will provide an update on our progress during the quarter and highlight our four key value drivers.

今天加入我的是我們的總裁兼執行長約翰·雅各布斯 (John Jacobs)，他將介紹我們在本季度取得的最新進展，並強調我們的四個關鍵價值驅動因素。

Additionally, John Trizzino, our President and Chief Operating Officer, will provide an update on our operating activities.

此外，我們的總裁兼營運長約翰·特里齊諾 (John Trizzino) 將提供我們營運活動的最新資訊。

And Dr. Bob Walker, Chief Medical Officer and Interim Head of Research and Development, will discuss our clinical development and pipeline.

首席醫療官兼臨時研發主管 Bob Walker 博士將討論我們的臨床開發和產品線。

Finally, Jim Kelly, our Chief Financial Officer and Treasurer, will provide an overview of our financial results and implications of the Sanofi partnership.

最後，我們的財務長兼財務主管吉姆凱利 (Jim Kelly) 將概述我們的財務表現以及與賽諾菲合作的影響。

I would now like to hand over the call to John Jacobs.

我現在想將電話轉交給約翰·雅各布斯。

Thank you, Erika, and thank you, everyone, for joining us.

謝謝你，艾莉卡，也謝謝大家加入我們。

I'm pleased to be with you today, along with the members of our executive team, to highlight our recent achievements, progress on our annual priorities, and the shaping of a new vision for Novavax.

我很高興今天能夠與大家一起，與我們的執行團隊成員一起，重點介紹我們最近取得的成就、年度優先事項的進展以及 Novavax 新願景的塑造。

When we spoke with you last quarter, we were taking the first steps on this exciting journey with the announcement of our global partnership with Sanofi.

當我們在上個季度與您交談時，我們宣布與賽諾菲建立全球合作夥伴關係，從而邁出了這一激動人心的旅程的第一步。

Our collaboration with Sanofi has allowed us to monetize the value of our COVID-19 vaccine and proven technology platform, and frees up resources to develop multiple opportunities in the vaccine space.

我們與賽諾菲的合作使我們能夠將 COVID-19 疫苗和成熟技術平台的價值貨幣化，並釋放資源來開發疫苗領域的多種機會。

Since then, we have worked hard to execute on our objectives and are beginning to position the company back toward its roots as an innovation-driven organization, while remaining a close commercial partner to Sanofi for our COVID-19 vaccine.

從那時起，我們一直努力實現我們的目標，並開始將公司定位為創新驅動型組織，同時仍然是賽諾菲在 COVID-19 疫苗方面的密切商業合作夥伴。

We are beginning to evolve from a company that is independently manufacturing, distributing, and commercializing vaccines on a global scale to a much more efficient and focused R&D model.

我們開始從一家在全球獨立生產、分銷和商業化疫苗的公司發展為更有效率和專注的研發模式。

This means that we intend to drive future value from additional business development activities and organic R&D via our proven and validated technology platform, with plans to unveil a new and expanded clinical pipeline by the end of this year and to seek to execute our plans within a much leaner operating model in 2025 and beyond.

這意味著我們打算透過我們經過驗證和驗證的技術平台，從額外的業務開發活動和有機研發中推動未來價值，併計劃在今年年底前推出新的和擴展的臨床管道，並尋求在一段時間內執行我們的計劃。

The potential value drivers of our business are outlined on slide 5 and include: value driver one, the Sanofi partnership; value driver two, late-stage pipeline; value driver three, leveraging our proven technology platform to drive additional partnerships and deals; and value driver four, new early-stage pipeline.

投影片 5 概述了我們業務的潛在價值驅動因素，其中包括： 價值驅動因素一：與賽諾菲的合作關係；價值驅動二、後期管道；價值驅動因素三，利用我們成熟的技術平台推動更多的合作夥伴關係和交易；價值驅動因素四，新的早期管道。

It is our intention that these potential value drivers will be supported by an appropriately scaled infrastructure, with significantly reduced [expenses] versus our 2024 baseline.

我們的目的是，這些潛在的價值驅動因素將得到適當規模的基礎設施的支持，與我們的 2024 年基線相比，[費用]顯著減少。

Jim Kelly will provide more detail and clarity on our expense projections later on in the call.

吉姆凱利稍後將在電話會議中提供有關我們的費用預測的更多細節和清晰度。

So let's take a moment to expand on each of these potential value drivers that are intended to be the foundation of our new growth strategy for Novavax.

因此，讓我們花點時間來詳細闡述這些潛在價值驅動因素，這些因素旨在成為 Novavax 新成長策略的基礎。

Value driver one, the Sanofi partnership.

價值驅動因素之一是賽諾菲合作關係。

The Sanofi partnership has four potential areas of value: first, immediate upfront payment and equity investment of approximately $570 million; next, mid-term milestones related to our partnered COVID-19 vaccine of approximately $350 million and Sanofi's independent flu COVID-19 combination program were another $350 million; third, anticipated royalty streams from both of these programs; and fourth, long-term royalties and/or milestones from any other vaccines developed by Sanofi, utilizing our COVID-19 vaccine and/or our Matrix-M adjuvant.

賽諾菲的合作關係有四個潛在的價值領域：第一，立即預付款和約5.7億美元的股權投資；接下來，與我們合作的 COVID-19 疫苗相關的中期里程碑約為 3.5 億美元，以及賽諾菲獨立的流感 COVID-19 組合項目另外 3.5 億美元；第三，這兩個項目的預期版稅流；第四，賽諾菲利用我們的 COVID-19 疫苗和/或 Matrix-M 佐劑開發的任何其他疫苗的長期特許權使用費和/或里程碑。

That means, for example, any additional combination vaccine commercialized using our COVID vaccine is eligible for royalties.

這意味著，例如，使用我們的新冠疫苗商業化的任何其他組合疫苗都有資格獲得特許權使用費。

Also, any new vaccine developed using our Matrix-M adjuvant is eligible for both milestones and royalties.

此外，使用我們的 Matrix-M 佐劑開發的任何新疫苗都有資格獲得里程碑和特許權使用費。

That being said, the partnership structure offers potential opportunities for decades to come.

話雖如此，這種夥伴關係結構為未來幾十年提供了潛在的機會。

And because Sanofi is a global leader in vaccine development and commercialization with a substantial presence and proven track record in seasonal respiratory vaccines in the US and around the world, we have the utmost confidence in their ability to perform when they begin commercializing our COVID-19 vaccine next year and potentially launch multiple additional vaccines using our technology in the future.

由於賽諾菲是疫苗開發和商業化領域的全球領導者，在美國和世界各地的季節性呼吸道疫苗領域擁有大量業務並擁有良好的業績記錄，因此我們對他們開始將我們的COVID-19 商業化時的表現能力充滿信心明年將推出疫苗，並可能在未來使用我們的技術推出多種其他疫苗。

We look forward to providing further updates on our partnership at the appropriate time.

我們期待在適當的時候提供有關我們合作夥伴關係的進一步更新。

Value driver two, Novavax late-stage pipeline.

價值驅動因素二，Novavax 後期管道。

As we have stated on prior calls, we are on track to independently initiate our own late-stage Phase 3 trial in fourth quarter of this year to evaluate our standalone influenza and COVID-19 influenza combination vaccines.

正如我們在先前的電話會議中所說，我們預計在今年第四季度獨立啟動我們自己的後期 3 期試驗，以評估我們的獨立流感疫苗和 COVID-19 流感組合疫苗。

Top-line data from this trial is expected by the middle of 2025.

該試驗的主要數據預計將於 2025 年中期獲得。

These assets have already demonstrated promising Phase 2 data.

這些資產已經展示了有希望的第二階段數據。

We intend to partner or monetize these assets, assuming successful Phase 3 results, rather than commercialize them ourselves, which should allow us to avoid significant infrastructure expense and execution risk.

假設第三階段取得成功，我們打算與這些資產合作或貨幣化，而不是自己將它們商業化，這應該使我們能夠避免大量的基礎設施費用和執行風險。

Moving on to value driver three, leveraging our proven technology platform to drive additional partnerships and deals.

轉向價值驅動因素三，利用我們成熟的技術平台來推動更多的合作夥伴關係和交易。

Beyond the two late-stage assets, our proven technology platform has the potential to offer other companies significant value.

除了這兩項後期資產之外，我們經過驗證的技術平台還有潛力為其他公司提供巨大的價值。

And our ambition is to be a partner of choice to help others enhance or even expand some of the established in-line vaccine franchises of larger players.

我們的目標是成為首選合作夥伴，幫助其他人增強甚至擴大大型企業的一些已建立的線上疫苗特許經營權。

For example, we believe that Matrix-M can help enhance many existing vaccines in the portfolios of other companies by boosting immunogenicity and lowering COGS without adding to the side effects burden.

例如，我們相信 Matrix-M 可以透過提高免疫原性和降低 COGS 來幫助增強其他公司產品組合中的許多現有疫苗，而不會增加副作用負擔。

Later in this call, Bob Walker will share some new data with you as an example of capability.

稍後在本次電話會議中，鮑勃沃克 (Bob Walker) 將與您分享一些新數據作為功能範例。

These Matrix-M attributes may also enable companies with clinical stage vaccine portfolios to make those vaccines more competitive as they strive for the best product profile, and even allow for the creation of new vaccines that might not have otherwise been possible.

這些 Matrix-M 屬性也可能使擁有臨床階段疫苗組合的公司在努力獲得最佳產品概況時使這些疫苗更具競爭力，甚至允許創造出原本不可能的新疫苗。

We continue to explore the potential of our technology and believe that we have only just begun to tap into the value of our platform to our company and portfolio and to that of other vaccine companies.

我們繼續探索我們技術的潛力，並相信我們才剛開始利用我們的平台對我們公司和投資組合以及其他疫苗公司的價值。

And finally, value driver four, new early-stage pipeline.

最後，價值驅動因素四，新的早期管道。

Our final and fourth potential value driver is the development of our own early-stage organic pipeline.

我們的最後一個也是第四個潛在價值驅動因素是我們自己的早期有機管道的發展。

Rather than focus our efforts on seasonal commercial execution of a single vaccine asset, we will instead invest our time, energy, and capital on the development of an expanded pipeline that uses our recombinant nanoparticle technology platform to develop new assets focused on infectious disease and respiratory, as well as potentially vaccines in other disease or areas and categories.

我們不會將精力集中在單一疫苗資產的季節性商業執行上，而是將時間、精力和資本投入到擴展管道的開發上，該管道使用我們的重組奈米顆粒技術平台來開發專注於傳染病和呼吸道疾病的新資產，以及其他疾病或領域和類別的潛在疫苗。

We will be looking to develop assets that we believe can make a significant difference for global public health and at the same time, present a significant commercial opportunity.

我們將尋求開發我們認為可以對全球公共衛生產生重大影響的資產，同時提供重要的商業機會。

We reserve the right to develop, launch, and commercialize any of these assets ourselves, should the emerging data and business case support it.

如果新出現的資料和業務案例支援的話，我們保留自行開發、啟動和商業化任何這些資產的權利。

For the remainder of 2024 and in line with our key value drivers, we will continue to execute on our four priorities, which you should be seeing on slide 6.

在 2024 年剩餘時間內，根據我們的關鍵價值驅動因素，我們將繼續執行我們的四個優先事項，您應該在投影片 6 中看到這些優先事項。

And these priorities are: priority one, the successful execution of our new partnership with Sanofi; priority two, driving incremental value from our technology platform via the initiation of our Phase 3 trial for CIC and flu, the development and unveiling of our new refreshed pipeline, and pursuing new business development opportunities; priority three, continue to reduce our R&D and SG&A costs in line with our prior stated targets and prepare for additional significant reductions to scale and cost as we enter 2025 and beyond; and finally, priority four, delivering our updated COVID-19 vaccine for the '24, '25 fall vaccination season.

這些優先事項是：第一，成功執行我們與賽諾菲的新合作關係；第二優先事項，透過啟動針對 CIC 和流感的第三階段試驗、開發和推出我們新的更新產品線以及尋求新的業務發展機會，推動我們的技術平台增值；優先事項三，根據我們先前設定的目標，繼續降低我們的研發和銷售、一般管理成本，並為進入 2025 年及以後進一步大幅削減規模和成本做好準備；最後，第四項優先事項是為「24」、「25」秋季疫苗接種季節提供更新的 COVID-19 疫苗。

As we enter the second half of this year, we look forward to sharing more details on our updated plans as we continue to forge a new path forward.

進入今年下半年，我們期待分享更多有關更新計劃的細節，繼續開闢新的前進道路。

Now I would like to hand it over to the team to discuss our results from the quarter in more detail, beginning with John Trizzino for our operating updates.

現在，我想將其交給團隊，更詳細地討論我們本季的業績，首先是約翰·特里齊諾 (John Trizzino) 的最新營運情況。

John?

約翰？

Thank you, John.

謝謝你，約翰。

Q2 was another quarter of progress for the business as we continue to lay the groundwork for a successful Nuvaxovid co-commercialization effort with Sanofi beginning in 2025.

第二季是業務取得的另一個季度進展，我們繼續為 2025 年開始與賽諾菲成功開展 Nuvaxovid 聯合商業化工作奠定基礎。

And with the '24, '25 season start less than one month away, we have continued to lay the groundwork for success by updating and filing for authorization of our updated COVID-19 vaccine formulation.

距離「24」、「25」季節開始還有不到一個月的時間，我們透過更新和申請更新的 COVID-19 疫苗配方的授權，繼續為成功奠定基礎。

Please turn to slide 8.

請翻到幻燈片 8。

In the US, as John mentioned, we are concentrating our commercial efforts for the remainder of the year on our largest market, the US.

在美國，正如約翰所提到的，我們將在今年剩餘時間內將商業工作集中在我們最大的市場——美國。

This should enable us to drive continued cost savings starting this season and continuing into 2025 and beyond, as we wind down our independent commercial presence in markets around the world, in anticipation of Sanofi taking the lead on commercialization of our COVID-19 vaccine starting in 2025.

隨著我們逐步減少在世界各地市場的獨立商業存在，預計賽諾菲將在2025 年起率先實現我們的COVID-19 疫苗的商業化，這將使我們能夠從本季度開始持續節省成本，並持續到2025 年及以後。

Turn to slide 9.

轉到投影片 9。

For the first time, we expect our product to be available in a pre-filled syringe in the US.

我們首次預計我們的產品將以預充式註射器的形式在美國上市。

The product will be arriving in the US this month and will be held in our warehouse, as we await authorization before we can begin distribution.

該產品將於本月抵達美國，並存放在我們的倉庫中，我們需要等待授權才能開始分銷。

Turn next to slide 10.

轉到投影片 10 旁邊。

We have adopted a highly targeted commercial approach and will focus on the retail pharmacy channel, where over 90% of administrations occurred last season.

我們採取了高度針對性的商業方法，並將重點放在零售藥房管道，上一季超過 90% 的給藥發生在該管道。

We have secured contracts with CVS Pharmacy, Rite Aid, Walgreens, Costco, as well as regional grocers and independent pharmacies and, thus, are tracking towards a significantly increased availability compared to last year.

我們已與 CVS Pharmacy、Rite Aid、Walgreens、Costco 以及地區雜貨商和獨立藥房簽訂了合同，因此，與去年相比，我們的供應量將顯著增加。

We have already initiated pre-season marketing efforts to build upon last year's campaign to drive increased awareness of Nuvaxovid.

我們已經啟動了季前行銷工作，以去年的活動為基礎，提高 Nuvaxovid 的知名度。

Please turn to slide 11.

請翻到投影片 11。

In Europe, given our upcoming transition of primary commercial responsibilities to Sanofi, we plan to conduct a lean, limited, and targeted commercial launch in the region, while still maintaining the necessary operations to ensure Sanofi is well positioned in Europe to execute beginning in 2025.

在歐洲，鑑於我們即將將主要商業責任移交給賽諾菲，我們計劃在該地區進行精益、有限和有針對性的商業啟動，同時仍保持必要的運營，以確保賽諾菲在歐洲處於有利位置，從2025 年開始執行。

This means we are focused on delivery of our updated vaccine in select European markets, including Germany, Italy, and Poland.

這意味著我們專注於在德國、義大利和波蘭等特定歐洲市場提供更新的疫苗。

We are already actively engaged in planning and partnership execution activities in the US and Europe, with the goal of creating a springboard for long-term value creation via enhanced Sanofi commercial sales of Nuvaxovid, while at the same time, streamlining our own commercial execution for the upcoming season.

我們已經在美國和歐洲積極參與規劃和合作執行活動，目標是透過增強賽諾菲 Nuvaxovid 的商業銷售，為長期價值創造創造一個跳板，同時簡化我們自己的商業執行即將到來的賽季。

The APA contracts we have been managing since the pandemic played an important role over the past few years in helping to manage vaccine distribution and access for millions of potential consumers around the world.

自大流行以來，我們一直管理的 APA 合約在過去幾年中在幫助管理全球數百萬潛在消費者的疫苗分發和獲取方面發揮了重要作用。

As the pandemic has moved to annual seasonal vaccination and vaccination rates around the world for COVID have dropped, we are working with our government customers to renegotiate, adjust, or where appropriate, exit these agreements, while preserving as much of their value as possible.

隨著大流行已轉向每年季節性疫苗接種，並且世界各地的新冠疫苗接種率有所下降，我們正在與政府客戶合作，重新談判、調整或在適當的情況下退出這些協議，同時盡可能保留其價值。

To recap, we remain intently focused on and are well on track for a more successful US vaccination season than we experienced last year.

總而言之，我們仍然全神貫注於美國疫苗接種季，並有望取得比去年更成功的疫苗接種季。

With anticipated FDA authorization of our '24, '25 formulation ahead of the fall campaign, manufacturing underway of our competitive pre-filled syringe presentation, continued traction in driving retail availability, and increased product awareness, we have all the components necessary for a better performance this '24, '25 US vaccination season launch, which we are confident will serve as a foundation for continued Nuvaxovid uptake in '25 and beyond under Sanofi.

預計FDA 將在秋季活動之前批准我們的'24、'25 配方，我們有競爭力的預填充注射器演示的生產正在進行中，推動零售可用性的持續增長以及產品意識的提高，我們擁有更好的所所需的所有組件我們相信，這將成為賽諾菲在 25 年及以後繼續採用 Nuvaxovid 的基礎。

Now, I want to turn the call over to Bob to discuss our research and development updates.

現在，我想將電話轉給鮑勃，討論我們的研發最新情況。

Please turn to slide 13.

請翻到投影片 13。

Thank you, John.

謝謝你，約翰。

I'm going to present key updates and highlights from our research and development activities from the last quarter, which support the four key value drivers John outlined earlier.

我將介紹上季度我們的研發活動的主要更新和亮點，這些活動支持約翰先前概述的四個關鍵價值驅動因素。

I'll discuss the '24, '25 COVID-19 strain change, our CIC and influenza programs, our efforts to expand potential opportunities for Matrix-M, and our internal preclinical pipeline.

我將討論 '24、'25 COVID-19 株變化、我們的 CIC 和流感計劃、我們為擴大 Matrix-M 潛在機會所做的努力，以及我們的內部臨床前管道。

Please turn to slide 14.

請翻到投影片 14。

With regard to our COVID-19 vaccine and the '24, '25 strain change, we were pleased that the CDC renewed their recommendation for universal vaccination for everyone six months and older for the upcoming season with the updated vaccine, and did not differentiate between among manufacturers or vaccine strains.

關於我們的COVID-19 疫苗和'24、'25 株變化，我們很高興CDC 更新了他們的建議，即在即將到來的季節使用更新的疫苗為所有六個月及以上的人普遍接種疫苗，並且沒有區分製造商或疫苗株之間。

Our update vaccine, which uses the JN.1 strain, often characterized as the trunk of the tree from which the currently circulating variants emerged, is well positioned to compete with the mRNA vaccines this fall, in light of the guidance issued by the leading regulatory and policy bodies.

我們的更新疫苗使用 JN.1 株，該株通常被描述為當前流行的變種出現的樹幹，根據主要監管機構發布的指導意見，該疫苗處於有利地位，可以在今年秋天與 mRNA 疫苗競爭和政策機構。

We submitted our regulatory packages for the strain change to both FDA and EMA in June.

我們在 6 月向 FDA 和 EMA 提交了菌株變更的監管方案。

And we continue to work with the regulators to facilitate a smooth review and approval in the effort to have our vaccine available early in the vaccination season.

我們將繼續與監管機構合作，促進順利的審查和批准，並努力在疫苗接種季節的早期提供我們的疫苗。

And as you've already heard from John, our updated vaccine is on track to be in warehouses this month and is expected to be ready for distribution upon authorization.

正如您從約翰那裡聽說的那樣，我們更新的疫苗將於本月入庫，預計在獲得授權後即可分發。

Please turn to slide 15.

請翻到投影片 15。

We continue to monitor the performance of our JN.1 vaccine against new variants in non-clinical studies.

我們將繼續在非臨床研究中監測 JN.1 疫苗針對新變種的表現。

Our data indicate that our vaccine targeting JN.1 should provide acceptable coverage for the currently circulating variants.

我們的數據表明，我們針對 JN.1 的疫苗應該能夠為目前流行的變種提供可接受的覆蓋範圍。

This slide shows neutralizing antibody responses with JN.1 vaccine in rhesus macaques.

這張幻燈片顯示了恒河猴中 JN.1 疫苗的中和抗體反應。

You can see that the antibody titers are robust across the spectrum of variants.

您可以看到，抗體滴度在所有變體範圍內都很穩定。

And this includes the KP.3 and KP.3.1.1 variants that are now widely circulating.

其中包括目前廣泛流傳的 KP.3 和 KP.3.1.1 變種。

Using these data, when we look at antigenic distance among these variants shown in the table to the right, we see that in all cases, the antigenic distances are below 2.0 antigenic units, indicating that the variants are all antigenically similar to JN.1.

使用這些數據，當我們查看右表中顯示的這些變體之間的抗原距離時，我們發現在所有情況下，抗原距離都低於2.0 抗原單位，表明這些變體在抗原上都與JN.1相似。

And that has been the consistent observation since we've started this monitoring, which we intend to continue to do for each newly prevalent variant throughout the season.

自從我們開始監測以來，這一直是我們觀察到的情況，我們打算在整個季節繼續對每個新流行的變體進行監測。

So as you can see, our data indicate that our vaccine targeting JN.1 should provide acceptable coverage for the currently circulating variants.

正如您所看到的，我們的數據表明我們針對 JN.1 的疫苗應該為目前流行的變種提供可接受的覆蓋範圍。

Please move to slide 16.

請移至投影片 16。

As John outlined, our second value driver is our late-stage pipeline, which has the potential to deliver vaccine candidates.

正如約翰所概述的那樣，我們的第二個價值驅動因素是我們的後期管道，它有潛力提供候選疫苗。

Our Phase 3 immunogenicity trial for our standalone influenza and CIC vaccines remains on track to start in the fourth quarter of this year, with top-line data expected by the middle of 2025.

我們的獨立流感和 CIC 疫苗的 3 期免疫原性試驗仍有望於今年第四季開始，預計將於 2025 年中期獲得頂線數據。

We have alignment with FDA on the use of a single Phase 3 immunogenicity study for both CIC and influenza programs and are still in dialogue with them on the feasibility of the accelerated approval pathway for both products.

我們與 FDA 就 CIC 和流感計畫使用單一 3 期免疫原性研究達成一致，並且仍在與他們就這兩種產品加速審批途徑的可行性進行對話。

We look forward to bringing you additional updates as we continue to advance these programs.

隨著我們繼續推進這些計劃，我們期待為您帶來更多更新。

Potential timeline and pathway to registration will be dependent upon full alignment with FDA and the results of the trial.

潛在的時間表和註冊途徑將取決於與 FDA 的全面協調和試驗結果。

As a reminder, data from our Phase 2 study demonstrated that our CIC vaccine induced anti-influenza neutralizing antibody levels in the top three plots, HAI antibody levels in the bottom three plots, and anti-spike neutralizing antibodies, bottom left, that were generally comparable, if not higher, than levels achieved after either of the comparator vaccines.

提醒一下，我們的第2 階段研究數據表明，我們的CIC 疫苗在頂部三個圖中誘導了抗流感中和抗體水平，在底部三個圖中誘導了HAI 抗體水平，以及左下角的抗尖峰中和抗體水平，這些抗體水平通常為與使用任何一種對照疫苗後所達到的水平相比，即使不更高，也是相當的。

We believe these results give us more confidence in the program and in the feasibility of an accelerated approval pathway for either or both vaccines, depending on final data readout.

我們相信，這些結果使我們對該計劃以及加速批准其中一種或兩種疫苗的可行性更有信心，具體取決於最終的數據讀數。

In preparing to move into Phase 3, we have received FDA concurrence on the conduct of a single Phase 3 immunogenicity study for both CIC and standalone influenza vaccines.

在準備進入第 3 階段時，我們已獲得 FDA 同意對 CIC 和獨立流感疫苗進行單一第 3 期免疫原性研究。

The trial will be conducted in older adults in the southern hemisphere in Australia and New Zealand during the off season.

該試驗將在淡季期間在南半球澳大利亞和紐西蘭的老年人中進行。

The FDA recommendations we have received during the pre-IND process are being incorporated into the trial.

我們在預 IND 流程中收到的 FDA 建議正在納入試驗中。

And we expect that with an anticipated fourth-quarter start, we should have top-line data by the middle of 2025 to enable internal decision making and potential partnering.

我們預計，隨著第四季度的開始，我們應該在 2025 年中期獲得頂線數據，以便進行內部決策和潛在的合作。

Please turn to slide 18.

請翻到幻燈片 18。

Now, I'd like to turn our attention to our proven tech platform, our third value driver, and to recent preclinical work aimed at expanding the utility of Matrix-M, our saponin-based adjuvant.

現在，我想將我們的注意力轉向我們經過驗證的技術平台，我們的第三個價值驅動因素，以及最近旨在擴大 Matrix-M（我們的皂苷佐劑）效用的臨床前工作。

Because we know that Matrix-M is a potent adjuvant for our nanoparticle viral vaccines, we decided to investigate whether Matrix could boost immune responses in other vaccines, such as in inactivated influenza split virus vaccine already licensed.

因為我們知道 Matrix-M 是我們的奈米顆粒病毒疫苗的有效佐劑，所以我們決定研究 Matrix 是否可以增強其他疫苗的免疫反應，例如已經獲得許可的滅活流感裂解病毒疫苗。

The results I'll show you indicate that Matrix-M increases the magnitude and breadth of antibody responses when given with a licensed egg-based influenza vaccine, with the potential to produce a more potent, more highly protective vaccine.

我將向您展示的結果表明，當與獲得許可的雞蛋流感疫苗一起使用時，Matrix-M 會增加抗體反應的幅度和廣度，並有可能生產出更有效、更保護的疫苗。

In the figure on the left, our IgG HAI responses in mice vaccinated with a licensed inactivated quadrivalent influenza vaccine in the left four bars and in mice vaccinated with the same vaccine plus Matrix in the right four bars.

在左圖中，左側四條柱顯示接種許可的滅活四價流感疫苗的小鼠的 IgG HAI 反應，右側四條柱顯示接種相同疫苗加 Matrix 的小鼠的 IgG HAI 反應。

Responses to all four influenza strains are boosted in the vaccine-plus-Matrix group.

在疫苗加 Matrix 組中，對所有四種流感病毒株的反應均增強。

In the figure to the right, competition binning experiments against a panel of monoclonal antibodies demonstrate that Matrix-induced antibodies directed to conserved epitopes in the HAI, resulting in broader cross-reactive responses.

在右圖中，針對一組單株抗體的競爭分箱實驗表明，基質誘導的抗體針對 HAI 中的保守表位，產生更廣泛的交叉反應。

These data demonstrate one of the most important attributes of Matrix, its ability to increase the magnitude and breadth of antibody responses, with the potential to produce a more potent, more highly protective vaccine.

這些數據證明了 Matrix 最重要的屬性之一，即它能夠增加抗體反應的程度和廣度，並有可能生產出更有效、更保護的疫苗。

Please turn to slide 19.

請翻至投影片 19。

But what about the potential for Matrix-M to enhance the activity of non-protein and nonviral vaccines?

但是 Matrix-M 增強非蛋白質和非病毒疫苗活性的潛力如何呢？

Bacterial capsular polysaccharides are known to be poorly immunogenic vaccine antigens, especially in infants and young children.

已知細菌莢膜多醣是免疫原性較差的疫苗抗原，特別是嬰兒和幼兒。

And we wanted to explore whether the benefits of Matrix could be extended to bacterial vaccines.

我們想探索 Matrix 的優勢是否可以擴展到細菌疫苗。

In this experiment, mice were vaccinated with a pneumococcal vaccine, either with or without Matrix added.

在該實驗中，小鼠接種了肺炎球菌疫苗，添加或不添加基質。

And anti-pneumococcal IgG antibody titers were increased over eightfold in mice that received vaccine plus Matrix.

在接受疫苗加 Matrix 的小鼠中，抗肺炎球菌 IgG 抗體滴度增加了八倍以上。

A similar adjuvant effect was observed when looking at functional antibodies that mediate subtype specific killing or OPK, a known correlate.

當觀察到介導亞型特異性殺傷或 OPK（已知的相關性）的功能性抗體時，觀察到類似的佐劑效應。

OPK responses were increased 2.6-fold to 7.5-fold in mice that received vaccine with Matrix for the four subtypes shown on the right.

在接受 Matrix 疫苗接種的小鼠中，OPK 反應增加了 2.6 倍至 7.5 倍，針對右側所示的四種亞型。

And notably, the subtype with especially low immunogenicity, subtype 23F at the bottom right, showed the greatest increase 7.5-fold with the addition of Matrix.

值得注意的是，免疫原性特別低的亞型，即右下角的23F亞型，在添加Matrix後表現出最大的增加7.5倍。

These preliminary data I've shown you suggest that Matrix could play an important role in augmenting certain currently available vaccines, such as influenza and pneumococcal vaccines, by increasing the quality and duration of immunity, reducing the amount of antigen needed per dose, and lowering manufacturing costs.

我向您展示的這些初步數據表明，Matrix 可以透過提高免疫品質和持續時間、減少每劑所需抗原量以及降低免疫水平，在增強某些現有疫苗（例如流感疫苗和肺炎球菌疫苗）方面發揮重要作用。

Our data also suggests that the repertoire of antigens that could be combined with Matrix for clinical benefit could perhaps be expanded to include bacterial polysaccharides, which we regard as an exciting area for more research.

我們的數據還表明，可以與 Matrix 結合以獲得臨床益處的抗原庫可能會擴展到包括細菌多醣，我們認為這是一個令人興奮的更多研究領域。

We believe that these Matrix attributes could be attractive to partners with established vaccine franchises.

我們相信，這些矩陣屬性可能會對擁有成熟疫苗特許經營權的合作夥伴有吸引力。

Please turn to slide 20.

請翻到投影片 20。

Finally, I want to discuss our new early-stage pipeline, which is our fourth value driver.

最後，我想討論我們新的早期管道，這是我們的第四個價值驅動因素。

As you heard, we are in the middle of a strategic assessment of our technology platform to determine how to best expand and refresh a new full product pipeline for Novavax.

正如您所聽到的，我們正在對我們的技術平台進行策略評估，以確定如何最好地擴展和更新 Novavax 的全新完整產品線。

And we are excited about the new initiatives that may spring from that review.

我們對這次審查可能產生的新舉措感到興奮。

As we work to complete this analysis, in parallel, we have continued to advance our RSV and avian influenza H5N1 preclinical vaccine candidates and continue to prepare both to move into the clinic.

在我們努力完成這項分析的同時，我們繼續推進我們的 RSV 和 H5N1 禽流感臨床前候選疫苗，並繼續為進入臨床做好準備。

At our last earnings call, we shared the animal model results on this slide.

在我們上次的財報電話會議上，我們在這張投影片上分享了動物模型的結果。

On the left are data showing that our RSV nanoparticle vaccine with Matrix was more immunogenic for both A and B sub-groups than a comparator RSV vaccine with AS01E adjuvant.

左邊的數據顯示，我們的含有 Matrix 的 RSV 奈米顆粒疫苗比含有 AS01E 佐劑的對照 RSV 疫苗對 A 和 B 亞群都更具免疫原性。

We believe our RSV candidate, though still early in development, has the potential to be first in class for both safety because of Matrix-M and effectiveness.

我們相信，我們的 RSV 候選產品雖然仍處於開發早期，但由於 Matrix-M，其安全性和有效性有可能成為同類第一。

The data on the right are for our H5N1 vaccine, showing that a single boost by injection was highly immunogenic in non-human primates previously primed with the seasonal influenza vaccine.

右側的數據針對我們的 H5N1 疫苗，顯示單次注射加強對於先前接種季節性流感疫苗的非人靈長類動物具有高度免疫原性。

And even a single intranasal boost, in red, showed responses above the commonly accepted threshold for protection of 1:40.

即使是單次鼻內加強（紅色），也顯示高於普遍接受的保護閾值 1:40 的反應。

An effective one-dose regimen for a pandemic influenza vaccine would provide a paradigm shift in public health and pandemic preparedness by providing more rapid protection and the potential to save many more lives than the current stockpiled two-dose regimens.

大流行性流感疫苗的有效一劑方案將比目前儲存的兩劑方案提供更快速的保護，並有可能挽救更多生命，從而為公共衛生和大流行防範帶來範式轉變。

We plan to start IND-enabling studies for both vaccines as soon as next month to support the start of Phase 1 clinical trials.

我們計劃最快下個月開始這兩種疫苗的 IND 研究，以支持一期臨床試驗的啟動。

And you will hear more from us later this year about additional areas of development for our technology.

今年晚些時候，您將聽到我們更多關於我們技術的其他開發領域的資訊。

Now to discuss our financials for the quarter, I want to hand the call to Jim.

現在要討論我們本季的財務狀況，我想把電話交給吉姆。

Thank you, Bob.

謝謝你，鮑伯。

Please turn to slide 22.

請翻到投影片 22。

We're focused on improving the financial health and performance of Novavax to enable long-term value creation.

我們專注於改善 Novavax 的財務狀況和業績，以實現長期價值創造。

Today, we outlined more detailed plans to deliver on this vision.

今天，我們概述了實現這一願景的更詳細計劃。

To begin, I'll share a few of the key themes from the second quarter of 2024 and look towards full-year 2024 and beyond.

首先，我將分享 2024 年第二季的一些關鍵主題，並對 2024 年全年及以後進行展望。

For the second quarter of 2024, Novavax recorded total revenue of $415 million, consisting primarily of $391 million from the GAAP revenue recognition for the $500 million upfront payment from Sanofi, received fully in the second quarter.

2024 年第二季度，Novavax 的總收入為 4.15 億美元，其中 3.91 億美元來自賽諾菲 5 億美元預付款的 GAAP 收入確認，該款項已在第二季度全額收到。

The remaining $119 million from the upfront milestone payment will be allocated over the transition services period through 2026.

預付款中剩餘的 1.19 億美元將在截至 2026 年的過渡服務期間分配。

We estimate full-year revenue recognition for this upfront payment to be approximately $400 million for 2024 and the remaining $100 million evenly split across 2025 and 2026.

我們預計這筆預付款的全年收入確認將在 2024 年約為 4 億美元，其餘 1 億美元將在 2025 年和 2026 年平均分配。

We have incorporated this GAAP revenue recognition into our full-year 2024 guidance.

我們已將此 GAAP 收入確認納入我們的 2024 年全年指引中。

As we continue to transform Novavax into a more lean and agile organization, we've reduced our second-quarter 2024 combined R&D and SG&A by 34% compared to prior year.

隨著我們繼續將 Novavax 轉型為更精簡和敏捷的組織，我們將 2024 年第二季的研發和銷售管理費用總額比去年同期減少了 34%。

When excluding Sanofi transaction costs for the period, we saw a decrease of 43%.

如果剔除賽諾菲當期交易成本，我們發現下降了 43%。

As we look forward to the full-year 2024, we are reiterating our targeted guidance for combined R&D and SG&A expenses of between $700 million and $750 million as we continue to resize our organization.

展望 2024 年全年，我們重申，隨著我們繼續調整組織規模，研發和銷售及管理費用合計在 7 億至 7.5 億美元之間的目標指引。

Novavax is prepared to initiate an additional cost reduction program to further reduce combined R&D and SG&A expenses, a portion of which we expect to be reimbursed by Sanofi under the agreement.

Novavax 準備啟動一項額外的成本削減計劃，以進一步減少研發和銷售、一般行政費用的綜合費用，我們預計賽諾菲將根據協議償還其中一部分費用。

For 2025, and net of reimbursement, we're targeting non-GAAP combined R&D and SG&A of below $450 million.

到 2025 年，扣除報銷費用後，我們的目標是非 GAAP 研發和銷售、一般管理費用合計低於 4.5 億美元。

We ended the second quarter of 2024 with cash and accounts receivable of approximately $1.1 billion.

截至 2024 年第二季末，我們的現金和應收帳款約為 11 億美元。

We believe the Sanofi agreement provides for a multibillion-dollar cash flow over time.

我們相信，隨著時間的推移，賽諾菲協議將提供數十億美元的現金流。

During the second quarter of 2024, we received approximately $570 million in cash payments that further improved our financial position.

2024 年第二季度，我們收到約 5.7 億美元的現金付款，進一步改善了我們的財務狀況。

Importantly, we are prioritizing the completion of our APAs, enabling a reduction to Novavax's commercial operating activities and complexity as a means to further reduce our costs.

重要的是，我們正在優先完成預約定價安排，從而減少 Novavax 的商業營運活動和複雜性，從而進一步降低我們的成本。

Please turn to slide 23 for a more detailed review of our second-quarter 2024 results.

請參閱投影片 23，更詳細了解我們 2024 年第二季的業績。

For the second quarter of 2024, we recorded total revenue of $415 million, compared to $424 million in the same period in 2023.

2024 年第二季度，我們的總營收為 4.15 億美元，而 2023 年同期為 4.24 億美元。

Our product sales of $20 million in the second quarter of 2024 were primarily related to the expiration of certain APA purchase rights.

2024 年第二季我們的產品銷售額為 2,000 萬美元，主要與某些 APA 購買權到期有關。

Our cost of sales for the second quarter of 2024 were $46 million as compared to $56 million for the same period in 2023.

我們 2024 年第二季的銷售成本為 4,600 萬美元，而 2023 年同期為 5,600 萬美元。

These periods include $24 million and $31 million, respectively, related to excess, obsolete, and expired inventory; losses on firm purchase commitments; and unutilized manufacturing capacity.

這些期間分別包括與過剩、過時和過期庫存相關的 2,400 萬美元和 3,100 萬美元；確定購買承諾的損失；以及未利用的製造能力。

As previously noted, for the second quarter of 2024, Novavax's combined R&D and SG&A of $208 million reflects a 34% reduction from the same period in 2023.

如前所述，2024 年第二季度，Novavax 的研發和銷售及管理費用總計為 2.08 億美元，較 2023 年同期減少 34%。

Excluding the $31 million in Sanofi transaction cost, our second-quarter 2024 combined R&D and SG&A was approximately flat to the first quarter of 2024.

不包括賽諾菲 3,100 萬美元的交易成本，我們 2024 年第二季的研發和銷售、一般管理費用合計與 2024 年第一季大致持平。

Please turn to slide 24.

請翻到投影片 24。

The Sanofi agreement provides for a multibillion-dollar potential across upfront equity investments, milestones, and royalties.

賽諾菲協議在前期股權投資、里程碑和特許權使用費方面提供了數十億美元的潛力。

The anticipated present value of the royalties on Sanofi's Nuvaxovid, flu COVID combination products, and new vaccines with Matrix-M are expected to be the largest individual component of value from this transaction.

賽諾菲 Nuvaxovid、流感新冠組合產品以及 Matrix-M 新疫苗的特許權使用費的預期現值預計將成為本次交易中最大的單獨價值組成部分。

Of note, this agreement reflects just one of the four pillars of value for Novavax.

值得注意的是，該協議僅反映了 Novavax 的四大價值支柱之一。

And given its many layers, it's worth another review to be better appreciated.

鑑於其層次眾多，值得再次審查以得到更好的欣賞。

Please turn to slide 25.

請翻到投影片 25。

The COVID-19 and Sanofi COVID flu combination related terms include the potential for up to approximately $1.3 billion in one-time milestone cash payments and equity investment.

COVID-19 和賽諾菲 COVID 流感組合相關條款包括高達約 13 億美元的一次性里程碑現金支付和股權投資的潛力。

During the second quarter of 2024, the initial cash payment included $500 million upfront and approximately $70 million equity investment in Novavax stock.

2024 年第二季度，初始現金支付包括 5 億美元的預付款和約 7,000 萬美元的 Novavax 股票股權投資。

Near-term Nuvaxovid COVID-19 milestones of $350 million and COVID flu combination milestones of $350 million should provide important cash flow to the company.

近期 Nuvaxovid COVID-19 里程碑為 3.5 億美元，COVID 流感組合里程碑為 3.5 億美元，應該會為公司提供重要的現金流。

We expect to complete database lock in the fourth quarter of 2024, which would enable earning the first $50 million milestone.

我們預計在 2024 年第四季完成資料庫鎖定，這將實現第一個 5000 萬美元的里程碑。

Revenue recognition for this milestone will be allocated over the transition services period through 2026.

此里程碑的收入確認將在截至 2026 年的過渡服務期內分配。

All other milestones under the agreement will be recognized in the period when earned.

協議項下的所有其他里程碑將在獲得時確認。

The $175 million BLA milestone is anticipated to align to our BLA PDUFA date and approval, which is presently targeted for April 2025.

1.75 億美元的 BLA 里程碑預計將與我們的 BLA PDUFA 日期和批准保持一致，目前目標是 2025 年 4 月。

The $225 million authorization transfer milestones are expected to follow, as we enable Sanofi to commercialize Nuvaxovid in the US and Europe for the 2025, 2026 vaccination season.

隨著我們幫助賽諾菲在 2025 年和 2026 年疫苗接種季在美國和歐洲將 Nuvaxovid 商業化，預計將實現 2.25 億美元的授權轉移里程碑。

The $75 million technology transfer milestone is expected to follow completion of our transition services obligations that we currently estimate to occur in late 2026.

7,500 萬美元的技術轉移里程碑預計將在我們目前估計 2026 年底完成的過渡服務義務完成後實現。

For the Sanofi flu COVID program, there are two milestones totaling $350 million related to the development and first commercial sale.

對於賽諾菲流感新冠項目，有兩個與開發和首次商業銷售相關的里程碑，總價值達 3.5 億美元。

Sanofi recently noted on their earnings call that they expect to start clinical trial manufacturing activities in 2024.

賽諾菲最近在財報電話會議上指出，他們預計將於 2024 年開始臨床試驗生產活動。

We are working to support Sanofi in these efforts and await more visibility into the potential timelines.

我們正在努力支持賽諾菲的這些努力，並等待對潛在時間表的更多了解。

In addition, Novavax is eligible to receive tiered royalties on net sales from COVID-19 mono and COVID combination products.

此外，Novavax 有資格從 COVID-19 單藥和 COVID 組合產品的淨銷售額中獲得分級特許權使用費。

This enables Novavax meaningful participation in future economics from the current and future products under this agreement.

這使得 Novavax 能夠透過本協議下的當前和未來產品有意義地參與未來經濟。

New vaccines developed with Matrix-M by Sanofi create a broad opportunity to advance this technology and provide Novavax with multiple revenue generation opportunities.

賽諾菲使用 Matrix-M 開發的新疫苗為推進這項技術創造了廣闊的機會，並為 Novavax 提供了多種創收機會。

We are eligible to receive up to $210 million in milestones plus ongoing royalties for two decades from the time of launch for each new vaccine developed utilizing Novavax's Matrix-M adjuvant.

對於使用 Novavax 的 Matrix-M 佐劑開發的每種新疫苗，我們有資格獲得高達 2.1 億美元的里程碑費用以及自上市之日起二十年的持續特許權使用費。

For example, if Sanofi developed five products with our Matrix-M, each with $1 billion in sales, this represents hundreds of millions in royalties per year, plus over $1 billion in one-time milestones.

例如，如果賽諾菲用我們的Matrix-M 開發了五種產品，每種產品的銷售額為10 億美元，這意味著每年數億的特許權使用費，加上超過10 億美元的一次性里程碑。

Novavax will support Sanofi as it prepares to advance all programs associated with this agreement.

Novavax 將支持賽諾菲準備推進與該協議相關的所有項目。

And Novavax will be eligible for cost reimbursement across the host of spend categories.

Novavax 將有資格獲得多種支出類別的費用報銷。

Please turn to slide 26.

請翻至投影片 26。

We're committed to creating a more lean and agile organization to align with the company's market opportunities.

我們致力於創造一個更精簡和敏捷的組織，以適應公司的市場機會。

To advance that goal, for 2024, we are reiterating our targeted combined R&D and SG&A expense guidance of $700 million to $750 million.

為了推進這一目標，我們重申 2024 年研發和銷售、一般行政費用合併目標為 7 億至 7.5 億美元。

We are currently at the high end of the range when accounting for the Sanofi transaction cost.

考慮到賽諾菲的交易成本，我們目前處於該範圍的高端。

And we will continue to push defined savings in our cost structure as the year progresses.

隨著時間的推移，我們將繼續在成本結構中推動明確的節約。

Novavax is prepared to initiate an additional cost reduction program to reduce combined R&D plus SG&A expenses, a portion of which we expect to be reimbursed by Sanofi under the agreement during 2025 and 2026.

Novavax 準備啟動一項額外的成本削減計劃，以減少研發加上銷售及管理費用的綜合費用，我們預計賽諾菲將在 2025 年和 2026 年期間根據協議償還其中一部分費用。

For 2025 and net of expected reimbursement, we expect our non-GAAP combined R&D and SG&A to be below $450 million.

到 2025 年，扣除預期報銷後，我們預計我們的非 GAAP 研發和銷售、一般管理費用總計將低於 4.5 億美元。

By 2026, we expect to drive down combined R&D and G&A expenses to below $350 million.

到 2026 年，我們預計將研發和一般行政費用合計降低至 3.5 億美元以下。

In addition, as we assume a secondary role in commercial markets, this enables the reduction of commercial and supply chain costs.

此外，由於我們在商業市場中扮演次要角色，這可以降低商業和供應鏈成本。

We are actively exploring the sale of our Czech Republic manufacturing facility, which could both provide cash proceeds and reduction to our ongoing operating cost.

我們正在積極探索出售我們的捷克共和國製造工廠，這既可以提供現金收益，又可以降低我們的持續營運成本。

Please turn to slide 27.

請翻至投影片 27。

Now turning to financial guidance that we have updated to incorporate the GAAP revenue recognition for the $500 million Sanofi upfront payment and outlook for APA and commercial sales.

現在轉向我們更新的財務指引，其中納入了賽諾菲 5 億美元預付款的 GAAP 收入確認以及 APA 和商業銷售的前景。

Of note, we received the full upfront payment of $500 million and approximately $70 million equity investment from Sanofi during the second quarter of 2024.

值得注意的是，我們在 2024 年第二季收到了賽諾菲 5 億美元的全額預付款和約 7,000 萬美元的股權投資。

For the full-year 2024 and on a GAAP basis, we expect to achieve total revenue of between $700 million and $800 million.

2024 年全年，以 GAAP 計算，我們預計總收入將達到 7 億至 8 億美元。

This includes $400 million of revenue recognition from the $500 million Sanofi agreement upfront payment and $25 million in royalty and other revenue from partner-related activities, which is recorded as licensing, royalty, and other revenue.

其中包括來自賽諾菲5 億美元協議預付款的4 億美元收入確認，以及來自合作夥伴相關活動的2500 萬美元特許權使用費和其他收入，這些收入記錄為許可、特許權使用費和其他收入。

We are updating our full-year 2024 product sales guidance and expect to achieve between $275 million and $375 million.

我們正在更新 2024 年全年產品銷售指引，預計將實現 2.75 億至 3.75 億美元的收入。

This includes $100 million for APAs already delivered through midyear and commercial product market sales of $175 million to $275 million in the second half of 2024.

其中包括已在年中交付的 1 億美元 APA，以及 2024 年下半年商業產品市場銷售額 1.75 億至 2.75 億美元。

Importantly, our expectations for the US market performance remain unchanged.

重要的是，我們對美國市場表現的預期保持不變。

And we expect the majority of remaining product sales to occur in the fourth quarter of 2024.

我們預計剩餘產品的大部分銷售將發生在 2024 年第四季。

The $150 million reduction to the midpoint of our full-year 2024 product sales guidance reflects $100 million from the New Zealand APA.

我們的 2024 年全年產品銷售指導中位數減少了 1.5 億美元，反映出紐西蘭 APA 提供的 1 億美元。

We are in ongoing discussions with New Zealand in response to their desire to cancel this agreement and $50 million from EU commercial sales, as we target a smaller set of prioritized countries for the 2024, 2025 vaccination season.

我們正在與紐西蘭進行持續討論，以回應他們取消協議以及從歐盟商業銷售中撥款 5000 萬美元的願望，因為我們在 2024 年和 2025 年疫苗接種季的目標是一小部分優先國家。

For the remaining APA agreements, our intent is to amicably negotiate or deliver doses or, when appropriate, exit agreements, with the goal of these activities to be cash flow neutral or favorable on a go-forward basis.

對於其餘的 APA 協議，我們的目的是友好協商或提供劑量，或在適當的情況下達成退出協議，這些活動的目標是在未來的基礎上實現現金流中性或有利。

To be conservative, we're removing APA sales from our forward-looking revenue expectations until further clarity is available on each.

保守地說，我們將 APA 銷售從前瞻性收入預期中刪除，直到每一項都進一步明確。

We'll instead emphasize realization of cost savings that come from exiting commercial markets.

相反，我們將強調透過退出商業市場來實現成本節約。

Our current operating plan, including the multiyear combined R&D and SG&A expense targets, highlights a path to maintaining our goal of at least one to two years of cash on hand, prior to receipt of cash flows from the Sanofi agreement in the form of milestones and royalties.

我們目前的營運計劃，包括多年綜合研發和銷售、一般行政費用目標，強調了在收到賽諾菲協議中里程碑形式的現金流之前，維持我們至少一到兩年手頭現金目標的途徑。

We look forward to sharing additional updates as we seek to improve Novavax's financial performance, cost structure, and strength to deliver shareholder value.

當我們尋求改善 Novavax 的財務表現、成本結構和提供股東價值的實力時，我們期待分享更多最新資訊。

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

說到這裡，我想將電話轉回給約翰，讓他做一些結束語。

Thank you, Jim.

謝謝你，吉姆。

Before we take your questions, I'd like to thank you all for joining us today and for your ongoing support as we work to build a new vision and future growth platform for Novavax.

在回答大家的問題之前，我要感謝大家今天加入我們，並感謝你們在我們努力為 Novavax 建立新願景和未來成長平台時給予的持續支持。

As you have heard, we're working hard to position the company for future growth, with a focus on our new value drivers including: driver one, the Sanofi partnership, which provides for a multibillion-dollar potential across upfronts, equity investment milestones, and royalties over time; value driver two, our late-stage pipeline; value driver three, leveraging our proven tech platform to drive additional partnerships and deals; and finally, value driver four, our new early-stage pipeline.

正如您所聽說的，我們正在努力為公司未來的成長做好定位，重點關注我們新的價值驅動因素，包括：驅動因素之一，賽諾菲合作夥伴關係，它提供了數十億美元的預付款潛力，股權投資里程碑，以及一段時間內的特許權使用費；價值驅動因素二，我們的後期管道；價值驅動因素三，利用我們成熟的技術平台推動更多的合作夥伴關係和交易；最後，價值驅動因素四，我們新的早期管道。

I'd now like to turn the call over to our operator for questions and answers.

我現在想將電話轉給我們的接線生詢問問題和解答。

Thank you.

謝謝。

(Operator Instructions) Roger Song, Jefferies.

（操作員說明） Roger Song，Jefferies。

Great.

偉大的。

Congrats for all the progress, and thank you for taking our questions.

恭喜所有的進展，並感謝您回答我們的問題。

Thank you, Roger.

謝謝你，羅傑。

Yeah, thank you, John.

是的，謝謝你，約翰。

So the first one is regarding the updated 2024 guidance.

第一個是關於更新的 2024 年指南。

Understanding nothing really changed for the US expectation mostly driven by the EU and New Zealand, just curious about the -- can you give us some of the updates regarding the US contracting, given this timing of the season?

了解美國的預期並沒有真正改變，主要是由歐盟和紐西蘭推動的，只是好奇——考慮到本賽季的這個時間點，您能給我們一些有關美國合約的最新情況嗎？

How confident you are you will be able to deliver this guidance in the US particularly?

您對能夠特別在美國提供這項指導有多大信心？

Thank you.

謝謝。

Good question, Roger.

好問題，羅傑。

John T., you want to take that one?

約翰·T.，你想拿那個嗎？

Yeah, sure.

是的，當然。

Operator, can you hear us okay?

接線員，你聽得到我們說話嗎？

Is that better, Roger?

這樣更好嗎，羅傑？

Yes, sir.

是的，先生。

Your line is open.

您的線路已開通。

Okay.

好的。

So, we had a bit of a technical difficulty there for a moment.

所以，我們暫時遇到了一些技術困難。

So maybe let's maybe back up in to address Roger's question.

那麼也許讓我們回過頭來回答羅傑的問題。

So as far as retail pharmacy contracting, execution so far has gone extraordinarily well.

就零售藥房承包而言，迄今為止執行情況非常順利。

As you can see from the slide that we presented, all of the top retail pharmacies are under contract, as well as many of the buying groups for the smaller grocers and independents.

正如您從我們展示的幻燈片中看到的那樣，所有頂級零售藥局以及小型雜貨店和獨立個體的許多購買團體都簽訂了合約。

We've made great progress over last year, with things like online schedulers and access and stocking orders that will be in each of those.

去年我們取得了巨大進步，其中包括線上調度程序以及訪問和庫存訂單等內容。

So much better progress from last year.

比去年進步了很多。

I think that will provide an opportunity for those interested in getting the vaccine to come into the pharmacy.

我認為這將為有興趣購買疫苗的人提供一個進入藥房的機會。

Some of our communication programs at the consumer level and then also at the pharmacist level will open that door to availability to the product.

我們在消費者層面以及藥劑師層面上的一些溝通計畫將為產品的可用性打開大門。

So I think all that's gone in a very positive direction.

所以我認為一切都在朝著非常正面的方向發展。

Excellent.

出色的。

Thank you.

謝謝。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Got questions.

有問題。

Congrats on many components of your portfolio showing progress today.

恭喜您的投資組合的許多組成部分今天都取得了進展。

About your CIC Phase 3 study, maybe if you could learn some protocol differences that you have integrated in your program, having the advantage of going third here.

關於您的 CIC 第 3 階段研究，也許您可以了解一些已整合到您的專案中的協議差異，從而具有在這裡排名第三的優勢。

So if you could maybe highlight that.

所以如果你能強調這一點的話。

And then, why do both the flu vaccine and the combination vaccine the same study versus maybe trying to do separately is the other question.

然後，為什麼流感疫苗和聯合疫苗都進行相同的研究，而不是嘗試分開進行，這是另一個問題。

Because there are control arm differences, and you obviously have pretty strong compelling data on strain lead from the previous NanoFlu candidate.

因為存在控制臂差異，而且您顯然對先前 NanoFlu 候選藥物的菌株先導有相當強的令人信服的數據。

So if you could maybe help clarify your strategy here, that would be helpful.

因此，如果您可以在這裡幫助闡明您的策略，那將會有所幫助。

And then I have a follow-up.

然後我有一個後續行動。

Mayank, thank you for your questions.

瑪雅克，謝謝你的提問。

Bob, two questions from Mayank.

鮑勃，Mayank 提出兩個問題。

The first is, have we made any changes to the protocol based on what we've learned, the fact that we're going third here?

第一個問題是，我們是否根據我們所了解到的情況對協議進行了任何更改，即我們將在這裡排名第三？

And then secondly, his question about one program versus two, if you want to handle that one.

其次，他關於一個程序與兩個程序的問題，如果你想處理那個程序的話。

Thank you.

謝謝。

Sure.

當然。

Thanks for that.

謝謝你。

As I mentioned earlier, we do have alignment with FDA on conducting a single Phase 3 protocol to support both products.

正如我之前提到的，我們確實與 FDA 一致同意實施單一的第 3 階段協議來支援這兩種產品。

And we remain in dialogue with them on some of the details.

我們仍在與他們就一些細節進行對話。

So I don't think we're prepared to actually discuss the specifics of the protocol design at this time.

所以我認為我們現在還沒有準備好實際討論協議設計的細節。

But let's say, to answer your second question, we will leverage certain efficiencies by incorporating both products into the same study, by using shared comparator control groups.

但是，為了回答你的第二個問題，我們將透過使用共享的比較對照組將兩種產品納入同一研究中，從而提高一定的效率。

And we also do know that the previous experience that you allude to, with the influenza vaccine, can also be leveraged to support the safety database for the new product.

我們也確實知道，您提到的先前流感疫苗的經驗也可以用來支援新產品的安全資料庫。

Okay, got it.

好的，明白了。

And then just on the long-term OpEx guidance that you put out there, given that there are some interesting parts of your earlier-stage pipeline that you'd look to also advance -- and you talked to some of that -- could you just give us a little bit of a mix of R&D, SG&A?

然後，就您提出的長期營運支出指導而言，考慮到您的早期階段管道中有一些有趣的部分，您也希望推進這些部分，並且您談到了其中的一些部分，您可以嗎？一些研發、SG&A 的組合嗎？

And also, when should we start to see some of these candidates get into the clinic from either you or even your partner, Sanofi?

另外，我們什麼時候應該開始看到您甚至您的伴侶賽諾菲（Sanofi）的這些候選人中的一些進入診所？

And thanks again for taking our questions.

再次感謝您提出我們的問題。

Good question, Mayank.

好問題，瑪雅克。

Jim Kelly will address the financial question.

吉姆凱利將解決財務問題。

Exactly.

確切地。

Mayank, you're right on spot in terms of capturing the dynamic of our cost structure change, while we strategically enable really the unlocking of significant value from our early-stage pipeline.

Mayank，您在捕捉我們成本結構變化的動態方面是正確的，而我們從策略上真正實現了從我們的早期管道中釋放重大價值。

We expect the vast majority and the majority of our cost structure, as we approach that 2026 below $350 million to be invested back in this value-creating early-stage pipeline as we continue to drive to a lean and agile organization.

我們預計，到 2026 年，我們的成本結構的絕大部分將低於 3.5 億美元，並在我們繼續推動精益和敏捷的組織建設的過程中，重新投入到這一創造價值的早期階段管道中。

And then, Mike, I believe the second part of your question was, when do we expect to see some new assets emerge in our pipeline and what timing might that be regarding hitting the clinic.

然後，麥克，我相信你問題的第二部分是，我們預計什麼時候會看到一些新資產出現在我們的管道中，以及什麼時候會進入診所。

I think we're excited to unveil what that new pipeline is by the end of the year.

我認為我們很高興能在今年年底前公佈新的管道。

As you know, we're also deep into a search for our new president of research and development.

如您所知，我們也正在深入尋找新的研發總裁。

We've had a lot of interest in Novavax, especially post the Sanofi deal, with further validation of our Matrix-M and proven technology platform, the fact that around the world people are recognizing what this technology is capable of.

我們對 Novavax 非常感興趣，特別是在與賽諾菲交易之後，隨著我們的 Matrix-M 和經過驗證的技術平台的進一步驗證，世界各地的人們正在認識到這項技術的能力。

And I hope everyone was able to hear some of the examples that Bob Walker shared, where we've added Matrix-M to other products that are established and in market right now, that are significant franchises for other companies.

我希望每個人都能聽到 Bob Walker 分享的一些範例，其中我們已將 Matrix-M 添加到目前已成熟並上市的其他產品中，這些產品對其他公司來說是重要的特許經營權。

We've shown an ability to potentially improve those products and even reduce their cost of production.

我們已經展示了改進這些產品甚至降低生產成本的能力。

These are significant.

這些都很重要。

And we believe our technology, we've only just begun to tap into that potential.

我們相信我們的技術才剛開始挖掘這種潛力。

So we're very excited to unveil what our exploration of that technology right now might be telling us on what else we can do beyond a seasonal vaccine, beyond even respiratory potentially.

因此，我們非常高興地公佈我們目前對該技術的探索可能會告訴我們，除了季節性疫苗，甚至呼吸系統疫苗之外，我們還能做些什麼。

We know that's where our wheelhouse is right now, but this technology has capabilities well beyond what we've explored with it so far.

我們知道這就是我們現在的駕駛室，但這項技術的功能遠遠超出了我們迄今為止所探索的範圍。

So as we get to that unveiling, we will be sharing also, Mayank, some timelines on that.

因此，當我們揭幕時，我們還將分享 Mayank 的一些時間表。

And we look forward to doing that in the future when we have more context.

我們期待在未來當我們有更多背景時這樣做。

Importantly, we're deep into the analysis and exploration of what else we could do with the tech and post Sanofi and post the last 18 months of lifting our going concern, putting the Gavi situation behind us, reducing our current liabilities significantly, improving our balance sheet, improving our cash position.

重要的是，我們正在深入分析和探索我們還可以利用這項技術做些什麼，在賽諾菲之後，我們在過去18 個月裡解除了我們的持續經營，將全球疫苗免疫聯盟(Gavi) 的情況拋諸腦後，顯著減少了我們的流動負債，改善了我們的財務狀況。

We've now put Novavax in the position to focus more on what we do best, which is research and development, from this amazing technology platform.

現在，我們讓 Novavax 更專注於我們最擅長的領域，即透過這個令人驚嘆的技術平台進行研發。

So we're excited to share that with you in the future.

因此，我們很高興將來與您分享這一點。

We're working diligently on transitioning the company away from focusing all of our energy on one product every season to now being able to focus on multiple shots on goal for potential future growth, which we laid out as our four drivers.

我們正在努力使公司從每個季節都將所有精力集中在一種產品上，轉變為現在能夠專注於實現未來潛在成長的多種目標，我們將其列為我們的四個驅動力。

We're in that transition now, and it's a period that we ask for a little bit of patience, as we wrap up our last season and we change the direction of the company toward this.

我們現在正處於這個過渡時期，在這個時期我們需要一點耐心，因為我們即將結束上一季，並改變公司的方向。

We're excited about what the future holds, and we're excited to unveil that pipeline in the coming quarters.

我們對未來感到興奮，並且很高興在未來幾季推出該管道。

That's helpful.

這很有幫助。

Look forward to learning more details on that.

期待了解更多相關細節。

Thank you.

謝謝。

(Operator Instructions) Alec Stranahan, Bank of America.

（操作員指示）Alec Stranahan，美國銀行。

Hey, guys.

嘿，夥計們。

Thanks for taking our questions.

感謝您回答我們的問題。

Just a couple from me.

只是我的一對。

One follow-up just on the CIC program.

一項關於 CIC 計劃的後續行動。

Is your expectation that there could be an approved CIC therapy in the US given you've shifted your Phase 3 enrollment to Australia and New Zealand?

鑑於您已將 3 期註冊轉移到澳洲和紐西蘭，您是否期望在美國獲得批准的 CIC 療法？

And then just curious, since the PDUFA for the BLA will be after handing the reins over to Sanofi, whether they had any input into the filing or if any of the terms under the collaboration are contingent upon receiving BLA.

然後只是好奇，由於 BLA 的 PDUFA 將在將控制權移交給賽諾菲之後，他們是否對備案有任何意見，或者合作下的任何條款是否取決於收到 BLA。

Thanks.

謝謝。

Alec, great to hear from you.

亞歷克，很高興收到你的來信。

Thank you for your questions.

謝謝您的提問。

I think the first question -- we just want to make sure we understand your question correctly.

我認為第一個問題——我們只是想確保我們正確理解你的問題。

If I heard you clearly, you were asking, is there the chance for a US approval since the recruitment is occurring in Australia?

如果我聽清楚的話，你是在問，既然招募是在澳洲進行的，是否有機會獲得美國的批准？

So I'll hand that over to Dr. Bob Walker.

所以我會把它交給鮑勃沃克博士。

Go ahead, Bob.

繼續吧，鮑伯。

Right.

正確的。

So the study is -- our plan is to conduct the study in the southern hemisphere, Australia, New Zealand, as mentioned.

所以這項研究是——我們的計劃是在南半球、澳洲、紐西蘭進行這項研究，如上所述。

The study would be done under US IND.

該研究將根據美國 IND 進行。

So those data would apply to a US application.

因此，這些數據將適用於美國的申請。

And I believe, Alec, your second question related to the timing of BLA and the related milestone with Sanofi and the timing of handoff of commercialization.

我相信，Alec，你的第二個問題涉及 BLA 的時間表、與賽諾菲的相關里程碑以及商業化移交的時間表。

Just to clarify, if you might clarify that, are you seeking to understand timing of the potential receipt of that milestone payment that would be associated with that?

只是為了澄清一下，如果您可以澄清這一點，您是否正在尋求了解與此相關的里程碑付款的潛在收到時間？

Yeah.

是的。

I guess, I was asking more in terms of input from Sanofi on the BLA and whether there's anything contingent milestones or otherwise on that BLA.

我想，我更多地詢問了賽諾菲對 BLA 的意見，以及該 BLA 是否有任何或有的里程碑或其他內容。

Thank you.

謝謝。

Obviously, we're working very closely with our partner, Sanofi, and very excited about that partnership and what it could mean in the future.

顯然，我們正在與我們的合作夥伴賽諾菲密切合作，並對這種夥伴關係及其未來的意義感到非常興奮。

But we have already filed that BLA, and that's already under review by FDA.

但我們已經提交了 BLA，並且已經在接受 FDA 的審查。

Yeah.

是的。

Just to add to that a little bit, there's ongoing and constant interaction with Sanofi on all of these necessary steps, the BLA importantly, one for the sake of the milestone.

補充一點，我們與賽諾菲就所有這些必要步驟進行持續不斷的互動，重要的是 BLA，這是為了實現這一里程碑而進行的互動。

But also as we move forward and look at each and every next season, the preparation for the season having the BLA in place is an important next step for us.

但隨著我們向前邁進並展望每個下賽季，為本賽季準備 BLA 是我們下一步重要的一步。

And so, yeah, there's a significant coordination between our organizations to make sure that we have the value of their inputs and that we are moving forward as quickly as we can.

所以，是的，我們的組織之間存在著重要的協調，以確保我們擁有他們的投入的價值，並確保我們盡快向前推進。

Makes sense.

有道理。

Thanks for the color.

謝謝你的顏色。

Eric Joseph, JPMorgan.

艾瑞克‧約瑟夫，摩根大通。

Hi, good morning, and thanks for taking the questions.

你好，早上好，感謝您提出問題。

First on commercial, just with your US sales guidance here, can you just talk about sort of what that anticipates in terms of dose volume you expect to go into market with, and how we should think about sort of gross margins for your COVID vaccine moving to a PFS format?

首先是商業方面，就您的美國銷售指導而言，您能否談談您預計進入市場的劑量量，以及我們應該如何考慮您的新冠疫苗的毛利率轉換為 PFS 格式？

And then, secondly, for the Phase 3 study starting later this year, maybe just sort of by way of backing into the design of that trial, can you talk a little bit about sort of what activity profile or -- yeah, comparative activity profile you'd like to be in market with or hope to be in market with a standalone flu vaccine?

其次，對於今年稍後開始的第三階段研究，也許只是為了支持該試驗的設計，你能談談什麼是活動概況，或者——是的，比較活動概況您希望或希望將獨立的流感疫苗推向市場嗎？

Thanks.

謝謝。

Eric, I will hand the first question over to John Trizzino.

艾瑞克，我將把第一個問題交給約翰·特里齊諾。

I don't believe, John, we're disclosing specifics of dose volumes et cetera for competitive reasons.

約翰，我不相信我們會出於競爭原因而透露劑量體積等細節。

But you may want to take an attempt at Eric's first question.

但您可能想嘗試回答埃里克的第一個問題。

Yeah.

是的。

No, I think what's important to talk about here is our readiness for the season.

不，我認為這裡要討論的重要的是我們對本賽季的準備。

The guidance is one thing, but our ability to accomplish what we think is aligned with that guidance has multiple factors: focus on the [Pharmacy One] which we've talked about, which is significantly important; also, what pricing strategy is.

指導是一回事，但我們完成我們認為與該指導一致的任務的能力有多個因素：關注我們已經討論過的[藥房一]，這非常重要；另外，定價策略是什麼。

And we're not going to get into disclosing what our kind of discounting strategy is on this call.

我們不會在這次電話會議上透露我們的折扣策略是什麼。

But all pulled together to make us well positioned -- availability of product near the end of the month and certainly at the start of the season, making sure that the contracts are in place, that we're well positioned from a discounting strategy to support access into the product, and then availability throughout the whole season.

但所有這些齊心協力，使我們處於有利的地位——產品在月底和季節開始時供貨，確保合約到位，我們從折扣策略到支持都處於有利地位訪問產品，然後在整個季節提供可用性。

So I think that's kind of the most important takeaway.

所以我認為這是最重要的收穫。

Thank you, John.

謝謝你，約翰。

And then Eric, your second question, if we understood you correctly, you were asking about, I believe, what type of profile we're seeking or hoping to have out of our clinical program that could make our product competitive against others.

然後，埃里克，你的第二個問題，如果我們理解正確的話，你是在問，我相信，我們正在尋求或希望從我們的臨床計劃中獲得什麼類型的資料，這可以使我們的產品與其他產品競爭。

Bob, did you want to address that?

鮑勃，你想解決這個問題嗎？

I'll say that, for the purposes of the Phase 3 trial, the statistical test will be that the combination product performs in a non-inferior way immunologically to each of the individual components; so to CIC to the influenza component and CIC to the COVID component.

我要說的是，為了第三階段試驗的目的，統計測試將是組合產品在免疫學上的表現不劣於每個單獨的成分；因此，CIC 對應於流感成分，CIC 對應於 COVID 成分。

So that would be the immunologic test.

這就是免疫學測試。

And the value of the product, I think, is the fact that it's a combination.

我認為產品的價值在於它是一個組合。

The design enables a hierarchical statistical analysis that can also evaluate superiority.

此設計支援分層統計分析，也可以評估優越性。

So that's built into the design.

所以這已融入設計中。

And so we'll be able to make conclusions on both of those points.

因此我們將能夠就這兩點得出結論。

Thank you, Bob.

謝謝你，鮑伯。

That was helpful.

這很有幫助。

On the design of the study and potential data points, we could assess afterwards.

關於研究的設計和潛在的數據點，我們可以事後再評估。

John T., any commentary on target product profile?

John T.，對目標產品概況有什麼評論嗎？

Yeah.

是的。

Commercial viability here is critically important, right?

這裡的商業可行性至關重要，對嗎？

As we look at the viability of our CIC program, primary focus of the trial, we also took the opportunity to look at standalone flu, right?

當我們研究 CIC 計劃的可行性（試驗的主要焦點）時，我們也藉此機會研究了獨立的流感，對吧？

So standalone flu continues to be an important product and public health vaccine profile.

因此，獨立流感仍然是重要的產品和公共衛生疫苗。

But we also believe we've got a very strong candidate that could demonstrate improved efficacy in the market.

但我們也相信我們有一個非常強大的候選人，可以在市場上展現更高的功效。

We also want to establish a seasonal influenza vaccine as a foundation for possible pandemic in the future.

我們也希望建立季節性流感疫苗，作為未來可能發生的疫情的基礎。

H5N1 continues to be important, and it's being observed around the globe.

H5N1 仍然很重要，全球各地都在觀察它。

So having the opportunity to have data coming out of our standalone flu vaccine, knowing what some of those other dynamics are, and knowing the profile of our flu vaccine and the significant improvements over existing flu vaccines, I think, position us well for future value creation.

因此，我認為，有機會獲得我們獨立流感疫苗的數據，了解其他一些動態，並了解我們流感疫苗的概況以及對現有流感疫苗的重大改進，這將使我們為未來價值做好準備創建。

Thank you, Bob and John.

謝謝你們，鮑伯和約翰。

And Eric, one last comment there is that, certainly, we believe that our technology can afford the development of vaccines with a very good tolerability profile.

艾瑞克，最後一個評論是，當然，我們相信我們的技術能夠開發出具有非常好的耐受性的疫苗。

And as the market moves toward combination, which our research indicates it should, with multiple seasonal diseases out there that people are trying to protect themselves against, that having a product where you can combine multiple antigens in with a very nice tolerability profile potentially versus competitors, is very important in the marketplace for consumers, as they make a decision on which combination vaccine they may want.

隨著市場走向組合，我們的研究表明，隨著人們試圖保護自己免受多種季節性疾病的影響，擁有一種可以將多種抗原組合在一起的產品，與競爭對手相比，具有非常好的耐受性。

So again, when we get the data, we'll assess the data, we'll steer the strategy, and tell us how competitive it is.

因此，當我們獲得數據時，我們將評估數據，我們將指導策略，並告訴我們它的競爭力如何。

But we have confidence in our tech platform that it has a good chance to really produce a nice profile that will be competitive.

但我們對我們的技術平台充滿信心，它有很好的機會真正產生具有競爭力的良好形象。

Thank you.

謝謝。

Thank you.

謝謝。

We don't have any further questions at this time.

目前我們沒有任何進一步的問題。

I'm sorry, we have -- yeah, no further questions at this time.

抱歉，我們現在沒有其他問題了。

This concludes our Q&A session as of the moment.

我們的問答環節到此結束。

Over to your speaker, John Jacobs, for any closing remarks.

請發言者約翰·雅各布斯發表結束語。

Please go ahead, sir.

請繼續，先生。

Thank you, operator.

謝謝你，接線生。

Appreciate it.

欣賞它。

And thank you, everyone, who joined us today.

感謝今天加入我們的所有人。

We appreciate your support.

我們感謝您的支持。

We appreciate your patience as we work through the future strategy for Novavax and start to deliver opportunities for long-term growth in four different categories that we highlighted today.

感謝您的耐心等待，我們正在製定 Novavax 的未來策略，並開始為我們今天強調的四個不同類別提供長期成長的機會。

We're excited about what the future holds as we continue to reduce our cost basis, move toward a more lean operating structure, and prepare for the next chapter in the company's history.

我們對未來感到興奮，因為我們將繼續降低成本基礎，轉向更精實的營運結構，並為公司歷史的下一個篇章做好準備。

Thank you so much for joining us, everyone.

非常感謝大家加入我們。

Thank you.

謝謝。

This concludes our conference for today.

我們今天的會議到此結束。

Thank you for your attendance.

感謝您的出席。

You may now disconnect.

您現在可以斷開連線。