Novavax Inc (NVAX) 2024 Q1 法說會逐字稿

Goo morning, and welcome to Novavax first-quarter 2024 financial results Operational Highlights Conference Call.

早安，歡迎參加 Novavax 2024 年第一季財務業績營運亮點電話會議。

(Operator Instructions) Please note, this event is being recorded.

（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.

我現在想將會議交給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 first quarter 2024 financial results and operational highlights.

早安，感謝大家今天加入我們討論我們 2024 年第一季的財務業績和營運亮點。

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.

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。

It's key strategic priorities, statement related to potential royalties and milestones, operating plans, objectives and prospects full-year 2024 financial guidance.

它是關鍵策略優先事項、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 2024 年全年財務指導前景。

The amount and impact of Novavax's cost reduction plans, it's future financial or business performance conditions or strategies, it's partnerships anticipated training and outcome of future regulatory filings and actions.

Novavax 成本削減計劃的金額和影響、未來的財務或業務績效條件或策略、合作夥伴預期的培訓以及未來監管備案和行動的結果。

And the ongoing development, marketing opportunities, manufacturing capacity and future availability of our vaccine candidates and key upcoming milestones.

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 was issued this morning and under the heading Risk Factors in our most recent Form 10-K and subsequent Form 10-Q filed with the Securities and Exchange Commission available at www.sec.gov.

有關這些因素的更多資​​訊出現在今天上午發布的關於幻燈片中前瞻性陳述的警告標題下以及我們向證券交易委員會提交的最新10-K 表格和隨後的10-Q 表格中的“風險因素”標題下。

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 uptake -- update or revise any of these statements.

在我們的網站 novavax.com 上。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，我們不承擔採納、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。

Joining me today is John Jacobs, our President and CEO, who will discuss our agreement with Sanofi announced this morning.

今天加入我的是我們的總裁兼執行長約翰·雅各布斯 (John Jacobs)，他將討論我們今天早上宣布的與賽諾菲的協議。

Additionally, John Trizzino, our President and Chief Operating Officer, will provide an update on our commercial activities; and Dr. Filip Dubovsky President of Research and Development, will discuss our clinical development pipeline.

此外，我們的總裁兼營運長 John Trizzino 將提供我們商業活動的最新資訊；和研發總裁 Filip Dubovsky 博士將討論我們的臨床開發管道。

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

最後，財務長兼財務主管 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。

Please turn to slide 4.

請翻到幻燈片 4。

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

謝謝艾莉卡，也謝謝大家今天加入我們。

Today, we enter a new and exciting chapter in the history of Novavax.

今天，我們進入了 Novavax 歷史上令人興奮的新篇章。

This morning, we announced that we have signed a global co-development and co-commercialization agreement with Sanofi.

今天早上，我們宣布與賽諾菲簽署了全球共同開發和共同商業化協議。

This agreement is both material and strategically important for Novavax.

該協議對 Novavax 來說既具有物質意義，又具有戰略意義。

It is a further validation of our technology platform and provide significant opportunity to drive value creation and benefit global public health.

這是對我們技術平台的進一步驗證，並為推動價值創造和造福全球公共衛生提供了重要機會。

The agreement represents a multibillion-dollar opportunity over time for Novavax via this agreement, we generate significant near-term cash flow, a strengthened balance sheet as well as the opportunity to strategically pivot to a new lean operating model, focusing more on our strengths in research and development and pipeline expansion to accelerate our growth and generate long-term value for our shareholders.

隨著時間的推移，該協議為Novavax 帶來了數十億美元的機會，透過該協議，我們產生了大量的短期現金流、強化的資產負債表以及策略性轉向新的精益營運模式的機會，更專注於我們的優勢研發和管道擴張，以加速我們的成長並為股東創造長期價值。

First, the upfront and near-term milestones associated with this agreement are anticipated to equate to approximately $1.3 billion in cash of which approximately half is expected within 10 days of signing.

首先，與該協議相關的前期和近期里程碑預計將相當於約 13 億美元現金，其中約一半預計在簽署後 10 天內完成。

These cash payments provide us with a significant capital infusion to help us manage our business.

這些現金支付為我們提供了大量資本注入，幫助我們管理業務。

And this in turn also enables us to remove the going concern status for Novavax.

這反過來也使我們能夠取消 Novavax 的持續經營狀態。

Second, beginning in 2025, it allows us to leverage one of the largest proven global leaders in the vaccine business to commercialize Nuvaxovid in the US, UK and Europe initially and worldwide over time.

其次，從2025 年開始，它使我們能夠利用疫苗業務領域最大的全球領先領導者之一，首先在美國、英國和歐洲實現Nuvaxovid 的商業化，並隨著時間的推移在全球範圍內實現商業化。

Affording hundreds of millions of dollars in potential cost synergies, enabling us to drive toward a new more lean operating model with total costs anticipated to be well below our prior stated cost reduction targets.

提供數億美元的潛在成本協同效應，使我們能夠推動新的更精益的營運模式，預計總成本將遠低於我們先前規定的成本削減目標。

And we expect our royalties and milestones from Sanofi's efforts with Nuvaxvoid to exceed the value of what our own efforts might have yielded if we had kept our product ourselves exclusively.

我們預計賽諾菲與 Nuvaxvoid 合作所獲得的特許權使用費和里程碑將超過如果我們自己獨家保留我們的產品的話我們自己的努力可能產生的價值。

By licensing Sanofi to use our Nuvaxvoid to develop their own combination flu and COVID products and to use Matrix-M as a component of other vaccines across their portfolio, we expect to realize substantial additional royalties and milestones value potentially in the billions of dollars, driven by Sanofi's product development and commercialization efforts over the years and decades to come.

透過授權賽諾菲使用我們的Nuvaxvoid 開發他們自己的流感和新冠肺炎組合產品，並使用Matrix-M 作為其產品組合中其他疫苗的組成部分，我們預計將實現大量額外的特許權使用費和里程碑價值，可能達到數十億美元，得益於賽諾菲多年來和未來幾十年的產品開發和商業化努力。

The royalties and milestones associated with potential new vaccines, Sanofi being developed using Matrix-M as well as those royalties and milestones anticipated from sales of our COVID-19 vaccine and the development of Sanofi's combination flu COVID and other potential combination vaccines should help us to sustain cash flow as we invest in our own R&D in an efficient and thoughtful manner for years to come.

與賽諾菲正在使用Matrix-M 開發的潛在新疫苗相關的特許權使用費和里程碑，以及我們的COVID-19 疫苗銷售和賽諾菲聯合流感COVID 和其他潛在聯合疫苗的開發預期的特許權使用費和里程碑，應該有助於我們在未來幾年中，我們以高效、周到的方式投資於自己的研發，從而維持現金流。

In fact, we have done all of this while retaining the ability to broaden and accelerate development of our own wholly owned pipeline.

事實上，我們在完成所有這一切的同時，保留了擴大和加速開發我們自己的全資管道的能力。

This includes the modification of our planned 2024 pivotal trial for our combination flu and COVID vaccine to now also include the potential to yield pivotal results -- for pivotal results for our standalone flu vaccine, and we now anticipate readouts for both the combination and our standalone flu vaccine in mid 2025.

這包括修改我們計劃的 2024 年流感和新冠疫苗聯合疫苗關鍵試驗，現在還包括產生關鍵結果的潛力——我們的獨立流感疫苗的關鍵結果，我們現在預計聯合疫苗和獨立疫苗的讀數2025 年中期流感疫苗。

In addition to our late-stage CIC and flu stand-alone programs, we will now be able to assess and contemplate the addition of some new early-stage programs to our pipeline and do so within the cost structure have a new lean operating model.

除了我們的後期 CIC 和流感獨立項目外，我們現在還能夠評估和考慮在我們的管道中添加一些新的早期項目，並在成本結構內實現新的精益運營模式。

For both our late-stage CIC and standalone flu programs and any early-stage programs we may choose to add to our pipeline in the coming quarters, we will be pragmatic, shareholder-focused and market aware about how to bring these assets forward.

對於我們的後期 CIC 和獨立流感項目以及我們可能選擇在未來幾個季度添加到我們的管道中的任何早期項目，我們將採取務實、以股東為中心和市場意識的方式來推進這些資產。

For example, through partnering out-licensing, co-development, co-commercialization or commercializing on our own, and we would consider commercializing on our own only for the right asset and with the benefit of our learnings from the COVID experience.

例如，透過合作對外許可、共同開發、共同商業化或自行商業化，我們會考慮僅針對合適的資產並利用我們從新冠疫情經驗中學到的知識自行商業化。

The key here is that we intend to have multiple organic opportunities from our own pipelines with optionality on how we decide to optimize value from them.

這裡的關鍵是，我們打算從我們自己的管道中獲得多種有機機會，並可以選擇如何決定如何優化它們的價值。

We look forward to providing additional details and updates on our new pipeline and future growth strategy for Novavax in the coming months as we operationalize with Sanofi.

我們期待在未來幾個月與賽諾菲合作營運時提供有關 Novavax 新產品線和未來成長策略的更多詳細資訊和更新資訊。

And finally, this transaction further validates both Novavax's product development capability and the extraordinary value of our Matrix-M adjuvant technology, potentially enhancing our future licensing and business development opportunities across our tech platform.

最後，此交易進一步驗證了 Novavax 的產品開發能力和 Matrix-M 佐劑技術的非凡價值，有可能增強我們整個技術平台未來的授權和業務發展機會。

In fact, we intend as part of our go-forward strategy to seek additional business development opportunities with our organic pipeline, new pipeline assets we intend to add in our Matrix-M and nanoparticle technology platforms.

事實上，作為我們前進策略的一部分，我們打算透過我們的有機管道、我們打算在 Matrix-M 和奈米顆粒技術平台中添加的新管道資產來尋求更多的業務發展機會。

So in summary, this transaction capitalizes our current business seeks to increase our future anticipated value from Nuvaxovid, while enabling us to significantly reduce our operating costs and complexity creates a future stream of royalties and milestones from multiple potential new products to be developed by Sanofi broadens and accelerates our own development pipeline and enhances our future deal, making capabilities, leveraging Matrix-M our late and early stage pipeline and our product development capabilities.

總而言之，這項交易利用了我們目前的業務，旨在提高我們從Nuvaxovid 獲得的未來預期價值，同時使我們能夠大幅降低營運成本和複雜性，從賽諾菲將開發的多種潛在新產品中創造未來的特許權使用費和里程碑。

Jim Kelly will now walk you through the financial terms.

吉姆凱利現在將向您介紹財務條款。

Jim?

吉姆？

Thank you, John

謝謝你，約翰

.

。

Please turn to slide number 5.

請翻到第 5 張投影片。

This new agreement with Sanofi provides for a multibillion dollar potential across upfront equity investment milestone and royalties.

與賽諾菲的這項新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 Novaxovid and CIC sales are expected to be the largest individual component of value in this transaction.

賽諾菲 Novaxovid 和 CIC 銷售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。

The COVID-19-related terms include the potential for up to approximately $1.3 billion in cash payments and equity investments, plus Novavax is eligible to receive two royalties on related product sales.

與 COVID-19 相關的條款包括高達約 13 億美元的現金支付和股權投資的潛力，此外 Novavax 有資格獲得相關產品銷售的兩筆特許權使用費。

In addition we're eligible to receive up to $200 million in milestones, plus ongoing royalties for each new vaccine developed utilizing Novavax's Matrix-M adjuvant.

此外，我們還有資格獲得高達 2 億美元的里程碑，以及使用 Novavax 的 Matrix-M 佐劑開發的每種新疫苗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.

例如，如果賽諾菲使用我們的 Matrix-M 開發了五種產品，每種產品的銷售額為 10 億美元。

This would represent hundreds of millions in royalties per year, plus up to a $1 billion in one-time milestone.

這意味著每年數億的特許權使用費，加上高達 10 億美元的一次性里程碑。

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

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

Near-term Novavaxovid COVID-19 milestones of $350 million in CIC milestones of another $350 million should provide important future cash flow to the Company.

近期 Novavaxovid COVID-19 里程碑為 3.5 億美元，CIC 里程碑為另外 3.5 億美元，應為公司提供重要的未來現金流。

In addition, the Novavax is eligible to receive tiered royalties on net sales in each of the COVID-19 related product categories that enable Novavax's meaningful participation in future economics from the current and future products under this agreement.

此外，Novavax 有資格獲得每個與 COVID-19 相關的產品類別的淨銷售額的分級特許權使用費，這使得 Novavax 能夠根據本協議從當前和未來的產品中有意義地參與未來經濟。

Please turn to slide number 6.

請翻到第 6 張投影片。

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

賽諾菲與 Matrix-M 共同開發的新疫苗為推動這項技術創造了廣闊的機會，可以為 Novavax 提供多種創收來源。

Novavax support Sanofi financial prepares to advance all programs associated with this agreement.

Novavax 支持賽諾菲財務準備推進與本協議相關的所有計劃。

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

Novavax 將有資格獲得多種支出類別的費用報銷。

John will now walk you through the first quarter commentary.

約翰現在將引導您完成第一季的評論。

John?

約翰？

Thank you, Jim.

謝謝你，吉姆。

Please turn to Slide 7.

請翻到幻燈片 7。

It took a lot of hard work over the past 15 months to get here and then determined focus on the strategic priorities we identified when I first joined the company to better position Novavax to execute significant business development opportunities like this partnership with Sanofi.

在過去的15 個月裡，我們付出了大量的努力才到達這裡，然後決定將重點放在我們第一次加入公司時確定的戰略優先事項上，以更好地定位Novavax 來執行重要的業務發展機會，例如與賽諾菲的合作。

In fact, since early 2023, the management team and I have been making significant progress on our three priorities.

事實上，自 2023 年初以來，我和管理團隊一直在我們的三個優先事項上取得重大進展。

Priorities one, delivering an updated product for the full vaccination season, priority two, reducing our rate of spend, managing our cash flow and evolving our scale and structure.

優先事項一是為整個疫苗接種季節提供更新的產品，優先事項二是降低支出率、管理現金流並發展我們的規模和結構。

And finally, priority three, leveraging our technology platform, our capabilities and our assets to drive additional value beyond Novavax alone.

最後，第三個優先事項，利用我們的技術平台、我們的能力和我們的資產來推動 Novavax 以外的額外價值。

Importantly, we had to make significant progress on the first two priorities in order to optimize the potential of our third priority.

重要的是，我們必須在前兩個優先事項上取得重大進展，才能充分發揮第三個優先事項的潛力。

And over the last 15 months by strengthening our balance sheet, reducing significant onetime legacy liabilities, including Gavi and proving that we could streamline our strain selection process and update our vaccine to align with regulatory requirements, we put Novavax in a position to be able to execute meaningful business development agreements.

在過去 15 個月中，透過加強我們的資產負債表、減少包括 Gavi 在內的重大一次性遺留負債，並證明我們可以簡化菌株選擇流程並更新我們的疫苗以符合監管要求，我們使 Novavax 能夠執行有意義的業務發展協議。

Sanofi agreement is strategically important for our company as it enables a pivot to a new growth strategy, a new lean operating model and a new chapter in the history of Novavax.

賽諾菲協議對我們公司具有重要的策略意義，因為它使我們能夠轉向新的成長策略、新的精實營運模式以及 Novavax 歷史的新篇章。

With that in mind, we have made appropriate adjustments to our priorities for the remainder of 2024.

考慮到這一點，我們對 2024 年剩餘時間的優先事項進行了適當調整。

For the remainder of this year, we will be focusing on the following.

今年剩下的時間裡，我們將重點放在以下工作。

Number one, prioritizing the successful transition of our new partnership with Sanofi.

第一，優先考慮我們與賽諾菲新合作關係的成功過渡。

Number two, continuing to expand and diversify organic opportunities and create additional value from our technology platform.

第二，繼續擴大有機機會並使之多樣化，並透過我們的技術平台創造額外價值。

Three, preparing to initiate an additional cost reduction program to reduce 2025 R&D plus SG&A expenses, net of Sanofi cost reimbursement to below $500 million.

第三，準備啟動額外的成本削減計劃，將 2025 年研發加上銷售、一般管理費用（扣除賽諾菲成本報銷）減少至 5 億美元以下。

And number four, delivering an updated product for the '24, '25 fall vaccination season.

第四，為「24」、「25」秋季疫苗接種季節提供更新產品。

As our strategy vision and new expanded pipeline for the company evolve.

隨著我們的策略願景和公司新擴展的管道的發展。

We intend to share more with you about the new path forward for Novavax.

我們打算與您分享更多有關 Novavax 前進道路的資訊。

We will spend the next several months analyzing and crystallizing our future pipeline and our strategic focus with the goal of sharing our updated plans for Novavax in more detail towards the end of this year.

我們將在接下來的幾個月中分析並明確我們未來的產品線和戰略重點，目標是在今年年底更詳細地分享我們對 Novavax 的更新計劃。

And now I would like to hand it off to discuss our results from the quarter in more detail, beginning with John Trizzino for our commercial updates.

現在我想更詳細地討論我們本季的業績，首先是約翰·特里齊諾 (John Trizzino) 的商業更新。

John?

約翰？

Thank you, John.

謝謝你，約翰。

Please turn to Slide 8.

請翻到幻燈片 8。

We are very excited about the potential of the Sanofi agreement for our business.

我們對賽諾菲協議對我們業務的潛力感到非常興奮。

And as John mentioned, our first priority is operationalizing the agreement to enable Sanofi to commence co-commercialization activities starting January 1, of next year.

正如約翰所提到的，我們的首要任務是實施該協議，使賽諾菲能夠從明年 1 月 1 日開始啟動聯合商業化活動。

This collaboration agreement with Sanofi is a validation of the significant investment made in a Novavax technology platform to date and of the dedicated and passionate effort of the many people that have contributed along the way.

與賽諾菲的這項合作協議是對迄今為止對 Novavax 技術平台的重大投資以及在此過程中做出貢獻的許多人的專注和熱情努力的驗證。

While we are steadfast in our belief that our COVID vaccine is the best one approved for use, it has been challenging to transition from being an innovator focused on developing vaccines for infectious diseases to being a commercial business focused on operational execution.

雖然我們堅信我們的新冠疫苗是獲批使用的最佳疫苗，但從專注於開發傳染病疫苗的創新者轉型為專注於營運執行的商業企業一直具有挑戰性。

Now partnered with Sanofi.

現與賽諾菲合作。

We see very clearly the opportunity to leverage their brand and global infrastructure for the benefit of public health revenue generation and increased return to our investors.

我們非常清楚地看到了利用他們的品牌和全球基礎設施來創造公共衛生收入並增加投資者回報的機會。

The burden of disease for COVID remains clear and well documented.

新冠病毒的疾病負擔仍然清晰且有據可查。

Vaccination continues to be recommended as the best defense for the prevention of severe disease hospitalization and death.

疫苗接種仍被建議作為預防嚴重疾病住院和死亡的最佳防禦措施。

Advisory committees like the CDC ACIP and other health policy bodies around the globe continue to recognize this need.

CDC ACIP 等諮詢委員會和全球其他衛生政策機構繼續認識到這項需求。

The COVID virus for now continues to circulate throughout the year, but with concentrated disease burden during the typical winter respiratory disease season from a late fall to early spring.

目前，新冠病毒全年持續傳播，但疾病負擔集中在秋末至早春的典型冬季呼吸道疾病季節。

The ongoing need for both COVID and influenza annual seasonal vaccination leads to the public health benefit for a single combination vaccine, a single visit and vaccination creates a convenience that we believe will translate into improved vaccination rates, especially in older adults who are most at risk.

對新冠病毒和流感每年季節性疫苗接種的持續需求導致了單一組合疫苗的公共衛生益處，單次就診和疫苗接種創造了便利，我們相信這將轉化為疫苗接種率的提高，特別是對於風險最大的老年人。

Sanofi as well recognized -- Sanofi is the well-recognized leader in influenza vaccines, and this collaboration agreement creates the opportunity for a COVID influenza combination vaccine with their existing license products.

賽諾菲也是公認的流感疫苗領域公認的領導者，這項合作協議為利用其現有許可產品開發新冠流感聯合疫苗創造了機會。

In parallel with preparing for Sanofi's 25 commercialization activities for the upcoming '24, '25 season.

同時為賽諾菲即將到來的 '24、'25 季節的 25 項商業化活動做準備。

We intend to support our key markets of the US, Europe and UK, but to do so in an increasingly streamlined, targeted and cost-efficient manner during our last season, commercializing on our own.

我們打算支持美國、歐洲和英國的主要市場，但在上一季我們會以越來越精簡、有針對性和成本效益的方式實現這一目標，並自行商業化。

Recently, both WHO and EMA recommended the use of a monovalent JN.1 lineage COVID-19 vaccine.

最近，世界衛生組織和 EMA 均建議使用單價 JN.1 譜系 COVID-19 疫苗。

Novavax plans to be ready to deliver our JN.1 protein-based vaccine globally this fall.

Novavax 計劃於今年秋季在全球提供我們的 JN.1 蛋白質疫苗。

And we have been developing and manufacturing this vaccine candidate as we anticipate the VRBPAC meeting for US strain selection on June 5.

我們一直在開發和生產這種候選疫苗，因為我們預計 6 月 5 日將舉行 VRBPAC 美國病毒株選擇會議。

Please turn to Slide 9.

請翻到投影片 9。

In the US, we intend to build upon our efforts from the '23 season by offering our vaccine in a more competitive single-dose prefilled syringe presentation and we intend to have product at distribution centers in the US no later than mid-August and ready for the season start in early September, pending FDA release.

在美國，我們打算在 23 年季節的努力基礎上，以更具競爭力的單劑量預裝注射器形式提供我們的疫苗，我們打算不遲於 8 月中旬在美國的配送中心提供產品並做好準備該季節將於9 月初開始，等待FDA 發布。

We expect that the CDC and competitors will do preseason disease awareness campaigns to drive vaccination rates and we will focus our efforts on building upon our increased health care provider awareness of Novavax, which we achieved last season, and we intend to focus our marketing efforts and investment on the retail and 60 plus age group, where we foresee the highest potential for conversion to Novavax's vaccine given their historically higher vaccination rates.

我們預計疾病預防控制中心和競爭對手將開展季前疾病意識活動，以提高疫苗接種率，我們將集中精力，提高醫療保健提供者對Novavax 的認識，這是我們上個賽季取得的成果，我們打算集中行銷工作和對零售和 60 歲以上年齡層的投資，考慮到歷史上較高的疫苗接種率，我們預計這些人群轉用 Novavax 疫苗的潛力最大。

In retail, we are having encouraging discussions which increased our optimism that we will have improved retail access for the season.

在零售方面，我們正在進行令人鼓舞的討論，這增強了我們對本季零售通路改善的樂觀態度。

As John mentioned, we have completed the submission of our BLA.

正如 John 所提到的，我們已經完成了 BLA 的提交。

While we are pleased with this progress, we have decided in consultation with the FDA to seek emergency use authorization for our updated vaccine, targeting JN.1 in order to be available by early September at the start of the season in a prefilled syringe.

雖然我們對這一進展感到高興，但我們已決定與 FDA 協商，為我們的更新疫苗尋求緊急使用授權，針對 JN.1，以便在 9 月初季節開始時以預裝注射器形式提供。

This pathway has been mapped out together with the FDA to enable an expedited review time frame and a more straightforward review process.

該途徑已與 FDA 共同製定，以實現加快審查時間表和更直接的審查流程。

This effort will occur in parallel with the BLA review process with the goal of having the potential for full BLA approval sometime this year.

這項工作將與 BLA 審查流程同時進行，目標是有可能在今年某個時候獲得 BLA 的全面批准。

So the BLA is indeed important.

所以BLA確實很重要。

We intend to achieve BLA approval, the most important factors for a successful campaign or a timely launch at the beginning of the season, broad availability in retail, high levels of awareness, which we already have from last year and a competitive product presentation and a prefilled syringe, we believe we can more effectively achieve these parameters this year by choosing the EUA option and parallel to the BLA pathway.

我們打算獲得BLA 批准，這是成功開展活動或在季節開始時及時推出的最重要因素、廣泛的零售可用性、高水平的認知度（我們從去年就已經擁有這些）以及具有競爭力的產品展示和預充式註射器，我們相信，透過選擇 EUA 選項並與 BLA 途徑平行，今年我們可以更有效地實現這些參數。

Please turn to Slide 10.

請翻到投影片 10。

With our pandemic era APA complete in Europe, we are entering a commercial and tender market for the first time in the region and are prioritizing our goal of timely delivery of an updated COVID-19 vaccine in several key European countries.

隨著我們在歐洲完成大流行時代 APA，我們將首次進入該地區的商業和招標市場，並優先考慮在幾個主要歐洲國家及時交付更新的 COVID-19 疫苗的目標。

In our major APA markets in Australia, New Zealand and Canada, we are seeing a more formal non-pandemic consumer demand pattern, and we are seeking to optimize the value of these contracts while doing what is in the best interest of public health for these customers.

在澳洲、紐西蘭和加拿大的主要 APA 市場，我們看到了更正式的非大流行消費者需求模式，我們正在尋求優化這些合約的價值，同時為這些合約做最符合公眾健康利益的事情。

We are in discussions regarding potential adjustments to dose volumes, pricing per dose and timing of delivery schedules that should better reflect market demand.

我們正在討論對劑量量、每劑定價和交付時間表的潛在調整，以更好地反映市場需求。

And where we can, we are seeking cash prepayment in exchange for moving to future delivery of doses.

在可能的情況下，我們正在尋求現金預付款，以換取未來劑量的交付。

Due to significant reductions in demand since the pandemic awaiting regulatory approvals and ongoing contract renegotiations, we are lowering total revenue guidance for 2024.

由於自大流行以來等待監管部門批准和正在進行的合約重新談判的需求大幅減少，我們降低了 2024 年的總收入指導。

Jim will discuss guidance on revenue and expenses in more detail shortly, though we have remaining value on our APAs and intend to optimize the value where we can over the next two to three years.

吉姆將很快更詳細地討論有關收入和支出的指導，儘管我們的預約定價安排仍有剩餘價值，並打算在未來兩到三年內盡可能優化該價值。

We are moving from a pandemic based APA period and toward a fully normalized vaccine market.

我們正在從基於大流行的 APA 時期轉向完全正常化的疫苗市場。

We look forward to working with our new partner to optimize our commercial opportunity.

我們期待與新合作夥伴合作，優化我們的商業機會。

Now to discuss our combination in influenza vaccines and other key R&D updates.

現在討論我們在流感疫苗和其他關鍵研發更新方面的組合。

I want to hand the call to Filip.

我想把電話轉給菲利普。

Thanks, John.

謝謝，約翰。

Please turn to Slide 12.

請翻到投影片 12。

Today I want to cover several topics.

今天我想談幾個話題。

First, I want to share data on our JN.1 candidate before I touch base on our revised CIC and influence of phase 3 plans.

首先，我想先分享我們的 JN.1 候選人的數據，然後再討論我們修訂後的 CIC 和第三階段計劃的影響。

Again, I want to show some preclinical data, on our optimized RSV vaccine candidate that we're evaluating for future development Finally, I want to introduce you to two innovative expansions of our technology because of vaccination and the development of a novel nanoparticle format, which we are exploring is an avian H5N1 pandemic vaccine.

再次，我想展示一些關於我們優化的RSV 候選疫苗的臨床前數據，我們正在評估這些候選疫苗的未來發展。形式的開發，我們正在探索的是一種禽流感 H5N1 大流行疫苗。

As John mentioned, these innovations are examples of work we've been doing over the past year to generate additional value from our technology platform.

正如約翰所提到的，這些創新是我們在過去一年中為從我們的技術平台創造額外價值所做的工作的例子。

Please turn to Slide 13 and 14.

請翻至投影片 13 和 14。

The World Health Organization and EMA have recommended the JN.1 lineage vaccines for the '24, '25 season.

世界衛生組織和 EMA 推薦在 '24、'25 季節使用 JN.1 譜系疫苗。

This is a variant we've previously advance in the commercial development.

這是我們之前在商業開發中推進的變體。

Here, I'm showing neutralizing responses in nonhuman primates that were vaccinated with XBB.1.5 vaccine and boosted with a single dose of JN.1. On the left hand, side, you can see the responses to JN.1 variants were low prior to boosting.

在這裡，我展示了接種 XBB.1.5 疫苗並用單劑量 JN.1 加強的非人靈長類動物的中和反應。在左側，您可以看到在增強之前對 JN.1 變體的反應較低。

On the right hand side, the responses to JN.1 and JN.1 drip variance are robust following a boost.

在右側，對 JN.1 和 JN.1 滴水方差的反應在提升後非常強勁。

These data provide us confidence our vaccine has utility against the currently circulating strains such as KP2 as well as potentially future proofing our vaccine against other variants that evolved from JN.1. The strain selection will be confirmed by VRBPAC on June 5,and we plan on submitting our strain change filing shortly after that.

這些數據讓我們相信我們的疫苗可以對抗當前流行的菌株（例如 KP2），並有可能在未來證明我們的疫苗可以對抗從 JN.1 進化而來的其他變種。 VRBPAC 將於 6 月 5 日確認菌株選擇，我們計劃在不久後提交菌株變更備案。

Okay.

好的。

Let's go to slide 15 and 16.

讓我們看投影片 15 和 16。

We've modified our plans for the upcoming Phase 3 study to include the evaluation of a stand-alone seasonal influenza vaccine.

我們修改了即將進行的第三階段研究的計劃，包括對獨立季節性流感疫苗的評估。

In addition to our COVID influence a combination vaccine in adults greater than six years of age.

除了我們的新冠病毒聯合疫苗外，還對六歲以上的成年人產生影響。

As depicted on the right hand side of the slide, this is planned to be a immunologic non-inferiority superiority study with our vaccine compared to age recommended licensed comparators.

如幻燈片右側所示，計劃將我們的疫苗與年齡推薦的許可比較藥物進行免疫學非劣效性研究。

Although we have previously received supportive regulatory guidance for the standalone influenza program, we will reconfirm the acceptability of this design for the flu influenza portion of the study.

儘管我們之前已經收到了針對獨立流感計畫的支持性監管指導，但我們將再次確認研究的流感部分設計的可接受性。

The study still on track for the second half of this year and out of this for decision-making will be available in mid '25.

該研究仍在今年下半年進行，用於決策的研究將於 25 年中期推出。

Okay.

好的。

Let's move to Slide 17 and 18.

讓我們轉到投影片 17 和 18。

We have optimized our RSVPreF, a nanoparticle vaccine antigen with a specific goal of maximizing the breadth of neutralizing responses.

我們優化了 RSVPreF，這是一種奈米顆粒疫苗抗原，其具體目標是最大化中和反應的廣度。

Here, I'm showing the immune responses in mice vaccinated with our RSV antigen with Matrix compared to the license GSK vaccine with the AS01E adjuvant, we use competitive bidding against a panel of monoclonal antibodies known to bind neutralizing epitopes, including site 0, II, IV, V and P27

在這裡，我展示了接種我們的RSV 抗原和Matrix 的小鼠與使用AS01E 佐劑的GSK 許可疫苗相比的免疫反應，我們對一組已知結合中和表位的單克隆抗體進行競爭性投標，包括位點0、II 、IV、V 和 P27

On the left hand side, our bidding results on our antigen.

在左側，我們的投標結果是我們的抗原。

On the right hand side are bidding results on the GSK antigen.

右側是GSK抗原的競標結果。

In both cases, a favorable breadth of response is demonstrated for our vaccine.

在這兩種情況下，我們的疫苗都表現出良好的反應範圍。

It's interesting to note, on the right hand panel, the P27 neutralizing sequences is not present on the GSK antigen.

有趣的是，在右側圖中，GSK 抗原上不存在 P27 中和序列。

Okay.

好的。

Let's go to Slide 19 and look at RSV neutralizing responses.

讓我們轉到幻燈片 19，看看 RSV 中和反應。

Here, I'm showing new responses for our RSVA on the left and RSVB on the right.

在這裡，我在左側顯示了 RSVA 的新回复，在右側顯示了 RSVB 的新回复。

We have driven six fold increase for RSVA compared to the license GSK vaccine, which references the difference of tighter from 3,700 to over 23,000.

與獲得許可的葛蘭素史克疫苗相比，我們已將 RSVA 增加了六倍，這指的是從 3,700 到 23,000 多個更嚴格的差異。

And for RSVB, a tire difference from 440 to over 1,500.

對於 RSVB，輪胎差異從 440 到超過 1,500。

This antigen can be used as a stand-alone vaccine or as part of a broader combination vaccine program.

該抗原可用作獨立疫苗或作為更廣泛的聯合疫苗計劃的一部分。

Based on our previous clinical experience with a related construct, we are evaluating whether additional preclinical or toxicology studies are required, partnering discussions for this antigen or ongoing.

根據我們先前對相關構建體的臨床經驗，我們正在評估是否需要額外的臨床前或毒理學研究，並就該抗原進行合作討論或正在進行。

Okay, please shift to slide 20 and 21 to look at our early progress in expanding our core technology into mucosal vaccinations.

好的，請轉到幻燈片 20 和 21，看看我們將核心技術擴展到黏膜疫苗的早期進展。

We've developed an intranasal formulation that includes our PS80 nanoparticle antigen with our Matrix-M adjuvant.

我們開發了一種鼻內製劑，其中包括 PS80 奈米顆粒抗原和 Matrix-M 佐劑。

In this experiment, we explore this technology with our COVID antigen, we've primed these mice with bivalent vaccine containing prototype in BA 5 and boosted them with intramuscular or intranasal XBB.1.5 vaccine formulations.

在本實驗中，我們用我們的COVID 抗原探索了這項技術，我們用含有BA 5 原型的二價疫苗對這些小鼠進行了免疫，並用肌內或鼻內XBB.1.5 疫苗製劑對它們進行了加強。

On the far left side, you can see the initial priming sequence induces no XBB.1.5 specific Mucosal IgA antibody.

在最左側，您可以看到初始引發序列不會誘導 XBB.1.5 特異性黏膜 IgA 抗體。

In the middle, after intramuscular boosting, eligible mucosal IgA was detected.

中間，肌肉內加強後，檢測到合格的黏膜IgA。

However, when the mice were boosted with intranasal vaccine, there was a very large IgA signal.

然而，當小鼠接受鼻內疫苗加強免疫時，出現了非常大的 IgA 訊號。

This is important because mucosal IgA is the first line of defense against respiratory viruses and has implications for prevention of infection and potentially impacting transmission.

這很重要，因為黏膜 IgA 是抵抗呼吸道病毒的第一道防線，對於預防感染和潛在影響傳播具有重要意義。

Let's move to Slide 22 for additional characterization of immune response.

讓我們轉到投影片 22，以了解免疫反應的更多特徵。

Here we're displaying XBB.1.5 new responses in the blood on the left and mucosal neutralizing responses on the right.

在這裡，我們在左側顯示血液中的 XBB.1.5 新反應，在右側顯示黏膜中和反應。

On the left-hand side, unsurprisingly, there was little evidence of serum XBB.1.5 neutralizing response after priming with bivalent BA5 vaccine.

不出所料，左側在用二價 BA5 疫苗免疫後幾乎沒有證據表明血清 XBB.1.5 中和反應。

However, XBB.1.5 responses were increased 27-fold with intramuscular boosting, and surprisingly, intranasal vaccination boosted these central responses over 10[fold].

然而，透過肌肉加強接種，XBB.1.5 反應增加了 27 倍，令人驚訝的是，鼻內疫苗接種將這些中樞反應增強了 10 倍以上。

When we looked at mucosal on the right-hand panel, once again, there was no response after priming, but a profound response was seen after intranasal boosting supporting the hypothesis, this approach may have utility and blocking infections.

當我們再次觀察右側面板上的黏膜時，啟動後沒有任何反應，但在鼻內加強後觀察到了深刻的反應，支持了這一假設，這種方法可能有用並阻止感染。

We believe the small rise in mucosal neutralizing responses following intramuscular boosting represents antibody transited from blood compartment.

我們認為肌內加強後黏膜中和反應的小幅上升代表抗體從血液隔間轉移。

These results are being prepared for publication, and we are evaluating this approach with different antigens in different preclinical models.

這些結果正在準備發表，我們正在不同的臨床前模型中使用不同的抗原來評估這種方法。

If these findings are validated in the clinic, this opens the door for a needle-free vaccination, and the potential to block infection and potentially transmission, specifically for respiratory and gastrointestinal infections whose point of entry is through the mucosa.

如果這些發現在臨床上得到驗證，這將為無針疫苗接種打開大門，並有可能阻止感染和潛在的傳播，特別是針對通過黏膜進入的呼吸道和胃腸道感染。

Okay, please turn to Slide 23 and 24 to look at the development of Matrix as a core for a new class of nanoparticles.

好的，請前往投影片 23 和 24，以了解作為新型奈米顆粒核心的 Matrix 的開發。

We've identified transmembrane domains in service in molecular anchors and can link antigens directly into the Matrix adjuvant.

我們已經確定了分子錨中使用的跨膜結構域，並且可以將抗原直接連接到基質佐劑中。

On the left-hand, image shows a model and an electronic photomicrograph of a classic PS80 nanoparticle.

左側影像顯示了經典 PS80 奈米粒子的模型和電子顯微照片。

You can see the antigens decorating the polysorbate core.

您可以看到裝飾聚山梨酯核心的抗原。

On the right-hand side, we have the novel matrix antiparticle where the antigens shown in blue are anchored directly into the vertices of the matrix structure.

在右側，我們有新型基質反粒子，其中藍色顯示的抗原直接錨定到基質結構的頂點。

This model is confirmed by the EM image on the right.

右側的 EM 圖像證實了該模型。

This new format is larger than the PS80 nanoparticle, and we hypothesize to facilitate antigen recognition and phagocytosis.

這種新形式比 PS80 奈米顆粒更大，我們假設可以促進抗原辨識和吞噬作用。

This also increases antigen density with up to 40 to 60 copies per nanoparticle, which may increase activation of antigen processing cells.

這也增加了抗原密度，每個奈米顆粒多達 40 至 60 個拷貝，這可能會增加抗原處理細胞的活化。

And finally, linking to antigen at an adjuvant assures co-delivery into a single endosome in antigen processing cells and may increase T cell responses.

最後，在佐劑上連接抗原可確保共同遞送至抗原處理細胞中的單一核內體中，並可能增加 T 細胞反應。

And this format is amenable to intramuscular and intranasal administration.

這種形式適合肌肉和鼻內給藥。

Okay.

好的。

Let's go to slide 25 and with how this performs in nonhuman primates.

讓我們看幻燈片 25，看看它在非人靈長類動物中的表現。

In this experiment, we used a highly pathogenic avian H5N1 2344b antigen, specifically American wigeon as a model antigen.

在本實驗中，我們使用高致病性禽類 H5N1 2344b 抗原，特別是美洲威根作為模型抗原。

This is the influenza clade, the devastating wild in domestic birds globally and is spread into our mammalian food chain.

這就是流感分支，是全球家禽中具有毀滅性的野生病毒，並已傳播到我們的哺乳動物食物鏈。

Here we're prime resets with our quadrivalent seasonal vaccine to more closely mimic the immulogic background in humans.

在這裡，我們用四價季節性疫苗進行了主要重置，以更接近地模仿人類的免疫背景。

We then boosted them with a single dose of H5N1 matrix nanoparticle vaccine intramuscularly or intranasally in measured neutralizing responses.

然後，我們透過肌肉或鼻內注射單劑量的 H5N1 基質奈米顆粒疫苗來加強它們，以測量中和反應。

On the left-hand side, a single 60-microgram intramuscular dose boost H5N1 neutral responses to a very high level in all animals.

在左側，單次 60 微克肌肉注射劑量可將所有動物的 H5N1 中性反應提高到非常高的水平。

And on the right, you can see a single intranasal dose results in a 100% seroconversion with a geometric mean titer of 263.

在右側，您可以看到單次鼻內劑量導致 100% 血清轉化，幾何平均滴度為 263。

I have a marked level of 1 to 40, which has been used in the literature as a level relevant for protection.

我的標記等級為 1 到 40，該等級已在文獻中用作與保護相關的等級。

Single-dose pandemic influenza vaccination has been elusive.

單劑大流行流感疫苗一直難以實現。

So certainly, these results caught our attention.

當然，這些結果引起了我們的注意。

If these results are validated in the clinic, it could lead to a game-changing approach because a single-dose vaccination in a pandemic setting would be much easier to deploy and could have a huge public health impact.

如果這些結果在臨床上得到驗證，可能會帶來一種改變遊戲規則的方法，因為在大流行環境下進行單劑量疫苗接種將更容易部署，並且可能對公共衛生產生巨大影響。

We're in discussion with government agencies on the best way to advance these candidates into the clinic, so we can evaluate them and this approach can be validated.

我們正在與政府機構討論將這些候選人推進臨床的最佳方式，以便我們可以評估他們並驗證這種方法。

Okay.

好的。

I covered a lot of territory today.

今天我涵蓋了很多領域。

As a summary, we're in commercial production of JN.1 vaccine, which has shown good results in preclinical evaluation and our goal is to have this product available at the beginning of the vaccination season.

總而言之，我們正在商業化生產 JN.1 疫苗，該疫苗在臨床前評估中顯示出良好的結果，我們的目標是在疫苗接種季節開始時提供該產品。

We've expanded our Phase 3 study to include stand-alone influenza, in addition to our combination vaccine and the study is on track to begin in the second half of this year, consistent with its original timeline.

除了我們的組合疫苗之外，我們還擴大了我們的第三階段研究範圍，將單獨的流感納入其中，並且該研究預計將在今年下半年開始，與最初的時間表一致。

We've optimized our RSV construct and we're evaluating additional work needs to be done before we decide on advancing the candidate into future development.

我們已經優化了 RSV 構造，並且正在評估在決定將候選方案推進未來開發之前需要完成的額外工作。

Finally, we developed two different derivatives of our core technology, the ability to vaccinate intranasally, with adjuvanted PS80 nanoparticles which in preclinical models induce mucosal immune response, while boosting serum-neutralizing responses.

最後，我們開發了兩種不同的核心技術衍生物，即鼻內接種疫苗的能力，帶有佐劑的 PS80 奈米顆粒，在臨床前模型中誘導黏膜免疫反應，同時增強血清中和反應。

And finally, we've identified molecular anchors, which can attach Amgen directly on to Matrix, and in nonhuman primates, prior to the seasonal vaccine, this has resulted in unprecedented immune response with a single dose for H5 pandemic vaccine.

最後，我們已經確定了分子錨，它可以將安進直接連接到 Matrix 上，並且在非人靈長類動物中，在季節性疫苗之前，這導致單劑 H5 大流行疫苗產生前所未有的免疫反應。

Okay, let me hand it over to Jim.

好吧，我把它交給吉姆。

But right, hey, thank you, Filip.

但是，嘿，謝謝你，菲利普。

Please turn to slides 26 and 27, we're focused on improving the financial health and performance of Novavax to enable long-term value creation.

請參閱投影片 26 和 27，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 announced the strategically important Sanofi agreement and have removed our going concern disclosure that evidence this progress.

今天，我們宣布了具有重要戰略意義的賽諾菲協議，並刪除了證明這一進展的持續經營披露資訊。

I will now share a few of the key themes for the first-quarter of 2024 and a look towards full year 2024 and beyond.

我現在將分享 2024 年第一季的一些關鍵主題以及對 2024 年全年及以後的展望。

For the first-quarter of 2024 Novavax recorded total revenue of $94 million and significantly improved our balance sheet profile by reducing current liabilities by $831 million.

2024 年第一季度，Novavax 的總收入為 9,400 萬美元，流動負債減少了 8.31 億美元，顯著改善了我們的資產負債表狀況。

The Gavi and Fujifilm settlements continue our efforts to address legacy contractual matters.

全球疫苗和免疫聯盟與富士膠片的和解將繼續我們努力解決遺留合約問題。

As we continue to transform Novavax into a more lean and agile organization.

隨著我們繼續將 Novavax 轉變為更精簡和敏捷的組織。

We reduced our Q1 2024 R&D and SG&A by 50% compared to prior year.

與去年相比，我們將 2024 年第一季的研發和銷售管理費用減少了 50%。

As we look to 2024, we are updating our targeted guidance for R&D and SG&A expenses of between $700 million and $750 million.

展望 2024 年，我們正在更新 7 億至 7.5 億美元之間的研發和 SG&A 支出的目標指引。

As we continue to resize our organization.

隨著我們繼續調整我們的組織規模。

For 2025, Novavax is prepared to initiate an additional cost reduction program to reduce R&D plus SG&A expenses to below $500 million, a portion of which we expect to be reimbursed by Sanofi under today's announced agreement, we ended the first quarter of 2024 with cash and accounts receivable of $517 million and have over $600 million in potential dose deliveries under APAs over the next three years.

對於2025 年，Novavax 準備啟動一項額外的成本削減計劃，將研發加上SG&A 費用減少至5 億美元以下，我們預計根據今天宣布的協議，賽諾菲將償還其中一部分，我們在2024 年第一季度結束時以現金和應收帳款為 5.17 億美元，未來三年根據 APA 的潛在劑量交付量將超過 6 億美元。

With the Sanofi agreement announced today, we have approximately $570 million in cash payments for the second quarter of 2024, that further improve our financial position.

隨著今天宣布的賽諾菲協議，我們將在 2024 年第二季獲得約 5.7 億美元的現金付款，這將進一步改善我們的財務狀況。

Please turn to slide 28.

請翻至投影片 28。

Turning to a more detailed view of our first-quarter 2024 financial results, where I'll provide commentary with specific focus on revenue, COGS and combined R&D and SG&A.

轉向我們 2024 年第一季財務業績的更詳細視圖，我將提供評論，特別關注收入、銷貨成本以及綜合研發和銷售管理費用。

For the first quarter of 2024, we recorded total revenue of $94 million compared to $81 million in the same period of 2023.

2024 年第一季度，我們的總營收為 9,400 萬美元，而 2023 年同期為 8,100 萬美元。

Our product sales of $82 million in the first-quarter of 2024 were primarily related to the EP. deliveries to Europe and reflect the successful completion of the European APA. agreement.

2024 年第一季我們的產品銷售額為 8,200 萬美元，主要與 EP 有關。向歐洲交付並反映出歐洲 APA 的成功完成。協定.

Royalties and other of $12 million for the first-quarter of 2024 include license fees and Matrix-M and reimbursement under our agreements with Takeda and SK Biosciences.

2024 年第一季的特許權使用費及其他 1,200 萬美元包括許可費和 Matrix-M 以及我們與武田和 SK Biosciences 協議下的報銷。

Our cost of sales for the first-quarter of 2024 were $59 million as compared to $34 million in the same period of 2023.

我們 2024 年第一季的銷售成本為 5,900 萬美元，而 2023 年同期為 3,400 萬美元。

These periods include $15 million and $25 million, respectively, related to excess obsolete or expired inventory losses on firm purchase commitments and unutilized manufacturing capacity.

這些期間分別包括 1500 萬美元和 2500 萬美元，與確定採購承諾和未利用的製造能力造成的過多過時或過期庫存損失有關。

As previously noted, for the first-quarter of 2024, Novavax's R&D plus SG&A of $175 million reflects a 50% and $180 million reduction from the same period in 2023.

如前所述，2024 年第一季，Novavax 的研發加上 SG&A 為 1.75 億美元，較 2023 年同期減少 50%，減少 1.8 億美元。

Please turn to Slide 29.

請翻到投影片 29。

We're committed to creating a more lean and agile organization to align the company with our market opportunities to advance that goal.

我們致力於創建一個更精簡和敏捷的組織，使公司與我們的市場機會保持一致，從而推進這一目標。

Over the past year, we've reduced our workforce by over 30% compared to the first-quarter of 2023.

在過去的一年裡，與 2023 年第一季相比，我們的員工人數減少了 30% 以上。

For 2024, we're updating our targeted combined R&D and SG&A expense guidance to $700 million to $750 million for our prior stated target of $700 million to $800 million as we continue to push for to find savings in our cost structure,

2024 年，隨著我們繼續努力在成本結構中尋求節約，我們將我們的目標研發和銷售及一般行政費用合併目標指引更新為7 億至7.5 億美元，而先前設定的目標為7 億至8億美元，

Novavax is prepared to initiate an additional cost reduction program to reduce 2025 R&D and SG&A expenses to below $500 million, as noted, a portion of which is expected to be reimbursed by Sanofi under the agreement.

如前所述，Novavax 準備啟動一項額外的成本削減計劃，將 2025 年的研發和銷售及管理費用減少至 5 億美元以下，其中一部分預計將由賽諾菲根據協議償還。

In addition, we're prioritizing improvements to long-term supply chain efficiency, including exploring the sale of our Czech Republic manufacturing facility.

此外，我們正在優先考慮提高長期供應鏈效率，包括探索出售我們的捷克共和國製造工廠。

Please turn to Slide 30.

請翻到幻燈片 30。

I'd like to discuss progress on our balance sheet and liability management.

我想討論一下我們的資產負債表和負債管理的進展。

Since December 31, 2022, we have reduced the company's current liabilities by $1.7 billion, including an additional $831 million reduction in the first-quarter of 2024, primarily driven by the Gavi and Fuji settlements.

自 2022 年 12 月 31 日以來，我們已將公司的流動負債減少了 17 億美元，其中 2024 年第一季又減少了 8.31 億美元，這主要是由於全球疫苗免疫聯盟和富士和解協議的推動。

Please turn to slide 31.

請翻至投影片 31。

Now turning to financial guidance.

現在轉向財務指導。

With an emphasis on our combined revenue and initial Sanofi payments that total $970 million to $1,170 million.

重點是我們的合併收入和賽諾菲初始付款總額為 9.7 億至 11.7 億美元。

This reflects a material improvement to our sources of cash flow for 2024, beginning with the $570 million of initial payments under the Sanofi agreement.

這反映出我們 2024 年現金流來源的實質改善，首先是根據賽諾菲協議支付 5.7 億美元的首期付款。

They'll be received in the second quarter of 2024, and reflect just the beginning have a potential multibillion economics across upfront equity investments, milestones and royalties under this agreement.

它們將於 2024 年第二季度收到，這只是本協議項下的前期股權投資、里程碑和特許權使用費方面潛在的數十億美元經濟效益的開始。

For 2024, we are updating our total revenue and now expect to achieve total revenue of $400 million to $600 million.

對於 2024 年，我們正在更新總收入，目前預計總收入將達到 4 億至 6 億美元。

Our projected total revenue includes $150 million to $250 million of APA sales based on expected dose delivery schedules and non-APA revenue of $250 million to $350 million, for a combination of our commercial market product sales plus royalties and other revenues from our partner related activities.

我們的預期總收入包括基於預期劑量輸送計劃的1.5 億至2.5 億美元APA 銷售，以及2.5 億至3.5 億美元的非APA 收入，包括我們的商業市場產品銷售加上特許權使用費和來自合作夥伴相關活動的其他收入。

The $400 million reduction to our full-year 2020.

2020 年全年減少 4 億美元。

For expected product sales guidance reflects the following $100 million from the Canada EPA as we await the Canadian order for 2024.

預計產品銷售指引反映了加拿大 EPA 提供的 1 億美元資金，我們正在等待加拿大 2024 年的訂單。

It's our intent to add this back when we have clarity on this order.

我們打算在明確此訂單後將其添加回來。

$250 million related to Australia, New Zealand and Israel, APA's as we work with those country on revised those delivery schedules for later periods and where possible are seeking potential repayment -- prepayments in 2024.

2.5 億美元與澳洲、紐西蘭和以色列有關，我們與這些國家合作修改了以後的交付時間表，並在可能的情況下尋求潛在的還款——2024 年的預付款。

Importantly, these updates reflect our goal of working in partnership with these key customers to adjust dose delivery schedules and volumes to better meet current demand while optimizing the remaining contract value through their completion.

重要的是，這些更新反映了我們與這些關鍵客戶合作的目標，調整劑量交付時間表和數量，以更好地滿足當前需求，同時透過完成來優化剩餘合約價值。

And finally, $50 million from EU commercial sales as we reduce commercial investments in select markets for the 2024, '25 vaccination season post Sanofi agreement.

最後，由於我們在賽諾菲達成協議後減少了 2024 年 25 疫苗接種季節對特定市場的商業投資，因此來自歐盟商業銷售的 5000 萬美元。

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, and thank you, everyone, for joining us today.

謝謝吉姆，也謝謝大家今天加入我們。

Before we take your questions, I would like to reiterate our key priorities for the remainder of this year.

在回答大家的問題之前，我想重申我們今年剩餘時間的主要優先事項。

Priority one, prioritizing the successful transition of our new partnership with Sanofi; priority two, continuing to expand and diversify our organic opportunities and create additional value via our technology platform; priority three, preparing to initiate an additional cost reduction program to reduce 2025 R&D plus SG&A expenses, net of Sanofi cost reimbursement to below $500 million and priority four delivering our updated product for the 24 25 fall vaccination season.

第一要務，優先考慮我們與賽諾菲新合作關係的成功過渡；第二優先事項，繼續擴大我們的有機機會並使其多樣化，並透過我們的技術平台創造額外價值；優先事項三，準備啟動額外的成本削減計劃，以將2025 年研發加上銷售管理費用（SG＆A 費用）（扣除賽諾菲成本報銷）降低至5 億美元以下，優先事項四為24-25 秋季疫苗接種季節提供我們的更新產品。

I would now like to turn the call over to our operator for Q&A.

我現在想將電話轉給我們的接線生進行問答。

Operator?

操作員？

Roger Song, Jefferies.

羅傑·宋，杰弗里斯。

Thank you for taking our question and congrats for the Sanofi deal.

感謝您接受我們的提問，並祝賀賽諾菲達成交易。

Thank you, Roger.

謝謝你，羅傑。

Hi, John.

你好，約翰。

A couple of questions from us.

我們有幾個問題。

Maybe start from the Sanofi deal.

或許可以從賽諾菲交易開始。

Can you give us a little bit clarity around the reimbursement for the co-development, commercial and regulatory costs, particularly helpful you already give us the guidance for 2024 and 2025.

您能否向我們介紹共同開發、商業和監管成本的報銷情況，這對您已經為我們提供的 2024 年和 2025 年指導特別有幫助。

And how should we think about the cost moving forward after 2025?

我們該如何考慮 2025 年後的成本變化？

Thank you.

謝謝。

Yes, Roger, good question.

是的，羅傑，好問題。

Roger, I'll have Jim Kelly address that, but we believe the deal affords us hundreds of millions of dollars in potential cost synergy.

羅傑，我會讓吉姆凱利解決這個問題，但我們相信這筆交易將為我們帶來數億美元的潛在成本協同效應。

But Jim, why don't you take the question?

但是吉姆，你為什麼不回答這個問題呢？

Yes, certainly.

是的，當然了。

And thank you, Roger.

謝謝你，羅傑。

The categories of cost reimbursement under this agreement include R&D activities that Novavax may do under the joint budget, to support the COVID-19 program from 2025Excellent.

本協議項下的費用報銷類別包括 Novavax 可能在聯合預算下進行的研發活動，以支持 2025 年起的 COVID-19 計畫。

That's very, very helpful.

這非常非常有幫助。

Thank you for color.

謝謝你的顏色。

And then in terms of the milestone payment, I see you laid out the milestone payments for the COVID side.

然後就里程碑付款而言，我看到您列出了新冠肺炎方面的里程碑付款。

Just curious about the COVID flu combination side, how much near-term milestone we should look at all those are back-ended milestone?

只是對新冠流感組合方面感到好奇，我們應該在多大程度上關注所有這些後端里程碑？

forward.

向前。

And that includes, for example, the pediatric studies that are ongoing and select medical affair activities.

例如，這包括正在進行的兒科研究和精選的醫療事務活動。

An additional category of reimbursement will include activities related to the technology transfer, this is going to be exceptionally important as we support Sanofi as they ramp up their commercial capabilities.

另一類報銷將包括與技術轉移相關的活動，這將非常重要，因為我們支持賽諾菲提高其商業能力。

In addition to that, we are entering into supply agreements for both COVID-19 supply in the coming years, plus for specifically Matrix-M adjuvant.

除此之外，我們還將在未來幾年內就 COVID-19 供應以及專門的 Matrix-M 佐劑簽訂供應協議。

And so we're eligible for reimbursement across all those.

因此，我們有資格獲得所有這些費用的報銷。

As I look specifically, and I'll put the supply to the side and I look to potential reimbursement in 2025 with respect to R&D activities and tech transfer, we believe that reimbursement amount could be up to $100 million and so think $75 million to $100 million.

正如我具體觀察的那樣，我將把供應放在一邊，並期待 2025 年研發活動和技術轉移方面的潛在報銷，我們認為報銷金額可能高達 1 億美元，因此認為報銷金額為 7500 萬美元至 100 美元百萬。

And then as I described, driving our R&D plus SG&A to below $500 million.

然後，正如我所描述的，我們的研發加上 SG&A 降至 5 億美元以下。

We then subtract that reimbursement.

然後我們減去該報銷金額。

And now we're talking about, hey, we're targeting $400 million or so on a go-forward basis.

現在我們正在談論，嘿，我們的目標是 4 億美元左右的前進基礎。

You're watching the continued evolution of our cost structure.

您正在關注我們成本結構的持續演變。

You know, we're nimble.

你知道，我們很靈活。

We know we act with urgency.

我們知道我們採取緊急行動。

This is our path.

這是我們的道路。

Excellent.

出色的。

That's very, very helpful.

這非常非常有幫助。

Thank you for color.

謝謝你的顏色。

And then in terms of the milestone payment, I see you laid out the milestone payments for the COVID side.

然後就里程碑付款而言，我看到您列出了新冠肺炎方面的里程碑付款。

Just curious about the COVID flu combination side, how much near-term milestone we should look at all those are back-ended milestone?

只是對新冠流感組合方面感到好奇，我們應該在多大程度上關注所有這些後端里程碑？

Go ahead, Jim.

繼續吧，吉姆。

Yes, listen, we're exceptionally excited by the potential for Sanofi to advance the combination of our COVID vaccine, along with their market-leading flu vaccine.

是的，聽著，我們對賽諾菲推進我們的新冠疫苗與其市場領先的流感疫苗組合的潛力感到非常興奮。

And those milestones on the $350 million are in fact, across both product development and approval milestones.

事實上，3.5 億美元的里程碑既涉及產品開發又涉及審批里程碑。

So non-sales base, but rather related to the near-term development and approval of those programs.

因此，這與銷售基礎無關，而是與這些計劃的近期開發和批准有關。

We're not offering additional detail at this time, but it is certainly a priority of the agreement.

我們目前不提供更多細節，但這肯定是協議的優先事項。

And Roger, it's John, just to build upon Jim's response to your good question, I want to make sure that everyone understands that this deal is not a $1.2 million or $1.3 billion deal.

羅傑，我是約翰，在吉姆對你的好問題的回答的基礎上，我想確保每個人都明白這筆交易不是 120 萬美元或 13 億美元的交易。

This is a multi-billion dollar deal.

這是一項價值數十億美元的交易。

The 1.3 billion represents the initial upfront, the $70 million equity investment in the company and the near term milestones associated with our activities related to Novaxovid and Sanofi developing their own combo vaccine.

這 13 億美元代表了該公司的初始預付款、7000 萬美元的股權投資，以及與 Novaxovid 和賽諾菲開發自己的組合疫苗相關活動相關的近期里程碑。

But importantly, the majority of what we see as the future value of this deal according to our estimates, come from the anticipated royalties that will be ongoing from Sanofi's ability to sell.

但重要的是，根據我們的估計，我們認為這筆交易的未來價值大部分來自賽諾菲銷售能力所帶來的預期特許權使用費。

Our COVID vaccine and their own combination or combination vaccines, plural, using our Nuvaxovid and through the deal, they have the opportunity to develop their own flu COVID combination, but also other combination products, including additional antigens, each of which we get royalties for.

我們的COVID 疫苗和他們自己的組合或組合疫苗，複數，使用我們的Nuvaxovid，透過交易，他們有機會開發自己的流感COVID 組合，還有其他組合產品，包括額外的抗原，我們對每種產品都獲得特許權使用費。

And in addition, there's another component beyond that, which is their access to our Matrix-M and adjuvant platform, which allows them to develop multiple products using Matrix-M.

此外，除此之外還有另一個組件，即他們可以存取我們的 Matrix-M 和佐劑平台，這使他們能夠使用 Matrix-M 開發多種產品。

Each of the products they may develop using our adjuvant technology platform has up to $200 million of potential one-time milestones as well as ongoing royalties, a flat royalty rate for years to come.

他們使用我們的輔助科技平台開發的每種產品都具有高達 2 億美元的潛在一次性里程碑以及持續的特許權使用費，即未來幾年的固定特許權使用費率。

When you look at the entirety of the agreement between the upfront payments and the near-term milestones, which are the $1.3 billion that we noted, including the equity investment.

當你查看預付款和近期里程碑之間的整個協議時，我們注意到，其中包括股權投資，即 13 億美元。

And then you consider the immensity of the potential royalties when we partner with the power of a company like Sanofi that's a world leader in vaccine development and commercialization with a leading flu franchise, plus what they could do with our Matrix-M over time.

然後，您會考慮當我們與像賽諾菲這樣的公司合作時，潛在的特許權使用費是巨大的，賽諾菲是疫苗開發和商業化領域的世界領先者，擁有領先的流感特許經營權，以及隨著時間的推移，他們可以用我們的Matrix-M 做什麼。

We truly believe this is a multibillion-dollar opportunity.

我們堅信這是一個價值數十億美元的機會。

So I want to make sure people don't misunderstand the potential of this partnership and what it might do for the future of Novavax and for global public health.

因此，我想確保人們不會誤解這種夥伴關係的潛力以及它可能對 Novavax 的未來和全球公共衛生產生的影響。

Excellent, that's very helpful.

太棒了，這非常有幫助。

I understand the milestone payment for the COVID combination is contingent upon the development approval, not the sales milestone payment.

我了解新冠肺炎組合的里程碑付款取決於開發批准，而不是銷售里程碑付款。

Got it.

知道了。

Okay.

好的。

And then maybe just lastly for the existing APA understanding you are reducing the APA to $600 million.

也許最後，對於現有的 APA 理解，您將 APA 減少到 6 億美元。

I just want to confirm that's already post negotiation with different parties of your partners, compared to the last time, maybe around $1 billion?

我只是想確認一下，這已經是與你們合作夥伴各方談判後的事情了，與上次相比，可能是10億美元左右？

And then the second part of the question is for the outstanding APA given the partnership with Sanofi, who's going to book the sales or Novavax will only get the royalty from the APA?

那麼問題的第二部分是，考慮到與賽諾菲的合作關係，對於尚未支付的 APA，誰將預訂銷售，或者 Novavax 將只從 APA 中獲得特許權使用費？

Thank you.

謝謝。

All right.

好的。

So looking to John Trizzino, maybe talk a little bit about the status of our APAs, but I'll just reiterate, bridging what the pieces to the change in our revenue guidance are.

因此，約翰·特里齊諾 (John Trizzino) 可能會談談我們的預約定價安排的狀況，但我只是重申一下，將各個部分與我們收入指導的變化聯繫起來。

Emphasizing that specifically the $350 million related to APAs, we're continuing active dialog with these APAs have been great partners.

強調特別是與預約定價安排相關的 3.5 億美元，我們正在繼續與這些預約定價安排進行積極對話，這些預約定價安排都是很好的合作夥伴。

The pieces there were, we took $100 million related to Canada and we've placed it to the side while we await that order.

我們拿走了與加拿大有關的 1 億美元，並在等待訂單時將其放在一邊。

It just seemed prudent at this time to not have it in our guidance.

此時不將其納入我們的指導中似乎是謹慎的做法。

While we await their order for the upcoming season, our intent is, of course, to add it back once we have clarity.

當我們等待他們下一季的訂單時，我們的目的當然是一旦我們明確了就將其添加回來。

And then when it comes to the $250 million across Australia, New Zealand and Israel, $200 million which is specific to Australia.

然後，當談到澳大利亞、紐西蘭和以色列的 2.5 億美元時，其中 2 億美元是專門針對澳洲的。

There are ongoing regulatory matters related to Australia.

與澳洲相關的監管事項正在進行中。

I'll let John hit that and perhaps characterize some of the dialog.

我會讓約翰點擊這個按鈕，也許還會描述一些對話的特徵。

Yes.

是的。

And Roger, just to build upon Jim's answer, I think you asked about the $600 million total go forward.

羅傑，在吉姆回答的基礎上，我認為您詢問了 6 億美元的總金額。

And I think Jim notes in his commentary that that did not include deferred revenue from Canadian prepayments in the past.

我認為吉姆在他的評論中指出，這不包括過去加拿大預付款的遞延收入。

So you might have been looking at that and thinking it could have been higher, but we excluded deferred revenue, which is an accounting matter and you looked at the $600 million , I believe you asked about -- and we can have Jim further clarify if needed, Roger.

所以你可能一直在考慮這一點，並認為它可能會更高，但我們排除了遞延收入，這是一個會計問題，你看了6 億美元，我相信你問過——我們可以讓吉姆進一步澄清，如果需要，羅傑。

You also asked about what happens if I heard you correctly, as the APAs wind down when it relates to Sanofi.

您還問如果我沒聽錯的話會發生什麼，因為與賽諾菲有關的預約定價安排逐漸結束。

And right now in our commentary, you heard us say that Sanofi will take commercialization on in 2025 for the US, Europe, UK and then over time, the rest of the globe.

現在，在我們的評論中，您聽到我們說賽諾菲將於 2025 年在美國、歐洲、英國商業化，然後隨著時間的推移，在全球其他地區實現商業化。

So we're maintaining responsibility to manage these APAs through their fruition in 2026, and we take that responsibility seriously and intend to bring forward the majority of value in the remaining APAs, albeit it may be spread out over time to better meet global market demand.

因此，我們仍然有責任管理這些預約定價安排，直到它們在2026 年取得成果，我們認真對待這一責任，並打算實現剩餘預約定價安排的大部分價值，儘管它可能會隨著時間的推移而分散，以更好地滿足全球市場需求。

But our future is not about the APA business.

但我們的未來與 APA 業務無關。

So as those APAs wind down, it's the final chapter in the legacy of the pandemic, we moved to a bright and exciting future for Novavax.

因此，隨著這些 APA 的結束，這是流感大流行遺產的最後一章，我們為 Novavax 邁出了光明而令人興奮的未來。

And when I first got here, Roger, the APA value in our business was 100% of our business opportunity.

羅傑，當我第一次來到這裡時，我們業務中的 APA 價值就是我們 100% 的商業機會。

It was the business model.

這是商業模式。

It was over $2 billion.

金額超過 20 億美元。

We've pulled down roughly two-thirds of that value.

我們已經降低了該值的大約三分之二。

In the last 15 months, we have roughly a third left, we intend to optimize that between now and the end of 2026, and we're looking forward to a bright future.

在過去 15 個月中，我們大約還剩下三分之一，我們打算從現在到 2026 年底對其進行優化，我們期待著光明的未來。

So as those APAs wind down, it's our intention to have those markets offered to Sanofi so they can begin commercializing our Nuvaxovid vaccine and the other products they may develop in those markets as APAs wrap up.

因此，隨著這些 APA 的結束，我們打算將這些市場提供給賽諾菲，以便他們可以在 APA 結束時開始將我們的 Nuvaxovid 疫苗以及他們可能在這些市場開發的其他產品商業化。

I hope that answers your question.

我希望這能回答你的問題。

Yes, it does.

是的，它確實。

Thank you.

謝謝。

That is it from us.

這就是我們的。

Thank you.

謝謝。

Congrats again.

再次恭喜。

Eric Joseph from JPMorgan.

摩根大通的艾瑞克‧約瑟夫。

Thanks. good morning and from me, my congrats on the deal.

謝謝。早上好，我對這筆交易表示祝賀。

What I'm hoping to do is just get a better -- a bit of a better understanding of the strategic positioning of your COVID-Flu program versus Sanofi's COVID-Flu ambitions, right?

我希望做的只是更了解你們的新冠肺炎項目的戰略定位與賽諾菲的新冠流感目標，對嗎？

Would you be targeting different market segments?

您會瞄準不同的市場區隔嗎？

And I'm also curious on whether you see opportunities for your own flu stand-alone, and maybe as a follow-up to that, can you talk about sort of what work Sanofi has done on the feasibility of a Nuvaxovid Fluzone Quad combination or Fluzone HD combo?

我也很好奇您是否看到了自己的流感獨立藥物的機會，也許作為後續行動，您能談談賽諾菲在 Nuvaxovid Fluzone Quad 組合的可行性方面所做的工作嗎？

Thanks.

謝謝。

Eric, for competitive reasons, we're not going to get into details on specific strategies around our pipeline assets.

艾瑞克，出於競爭原因，我們不會詳細介紹圍繞我們的管道資產的具體策略。

But what I can say to address your question is we're very excited that we've been able to double our shots on goal in our late-stage program, by adjusting our original CIC clinical trial, as Filip described today to include a stand-alone flu vaccine.

但我能回答你的問題的是，我們非常興奮，通過調整我們最初的 CIC 臨床試驗，我們能夠在後期計劃中將射門次數加倍，正如 Filip 今天所描述的，包括一個支架-單獨的流感疫苗。

And Filip shared some exciting data on H5N1 flu, and has previously shared positive immunogenicity and other data results from our prior flu work.

Filip 分享了一些有關 H5N1 流感的令人興奮的數據，之前也分享了我們之前流感工作的陽性免疫原性和其他數據結果。

So we're very excited that we have two potentially registration-worthy vaccine assets, this time next year, should we succeed with that clinical program.

因此，我們非常高興我們擁有兩種可能值得註冊的疫苗資產，明年這個時候，如果我們的臨床計劃成功的話。

And as I said before, our strategy is to consider optionality on how we would monetize those and bring them forward should we have success.

正如我之前所說，我們的策略是考慮如何將這些貨幣化，並在我們取得成功時將其推進。

And that could include additional partnering and business development, out-licensing to other organizations who would like to see those vaccines, creating additional deals of this nature that we have with Sanofi or deciding to go it alone.

這可能包括額外的合作和業務發展、向希望看到這些疫苗的其他組織授予許可、與賽諾菲達成此類性質的額外交易或決定單獨行動。

What we'll do is allow the data to feed that strategy, Eric, to make sure we see how those cards overturn by mid next year, and that will guide further strategic thinking on the assets.

艾瑞克，我們要做的就是讓數據為該策略提供支持，以確保我們在明年中期之前看到這些卡牌將如何顛覆，這將指導對資產的進一步策略思考。

What we're excited about is the value of our technology platform, and that the Sanofi deal has further validated the immense value that Matrix-M and our nanoparticle technology have to offer, and we intend to keep optimizing that.

我們感到興奮的是我們的技術平台的價值，賽諾菲的交易進一步驗證了 Matrix-M 和我們的奈米顆粒技術所能提供的巨大價值，我們打算繼續優化它。

And in addition, what you see is we're expanding our portfolio with some early stage work, exploring RSV, et cetera.

此外，您會看到我們正在透過一些早期工作來擴展我們的產品組合，探索 RSV 等。

So hopefully, that addresses your question.

希望這能解決您的問題。

I'd rather not comment on what Sanofi may be thinking, or why they came to the conclusion that this is such an exciting platform to partner with, but we're not surprised because we know the value our technology can offer.

我不想評論賽諾菲可能在想什麼，或者為什麼他們得出這樣的結論：這是一個令人興奮的合作平台，但我們並不感到驚訝，因為我們知道我們的技術可以提供的價值。

And I'll leave it there for now.

我暫時把它留在那裡。

Thank you.

謝謝。

Great, thanks for the color.

太好了，謝謝你的顏色。

Alec Stranahan from Bank of America.

美國銀行的亞歷克‧斯特拉納漢 (Alec Stranahan)。

Hey guys, congrats on the deal.

嘿夥計們，恭喜這筆交易。

This is John for Alex.

這是亞歷克斯的約翰。

Probably just some clarification questions for us.

可能只是向我們提出一些澄清問題。

I think the first one, for the $350 million in milestones for activities related to Nuvaxovid.

我認為第一個是 Nuvaxovid 相關活動的 3.5 億美元里程碑。

What are the potential milestones in the upcoming like a year or two that we could see for your company to receive?

在接下來的一兩年內，我們可以看到貴公司獲得哪些潛在的里程碑？

That's the first question.

這是第一個問題。

And secondly, for marketing and branding, in terms of future commercialization of Sanofi branded products.

其次，對於行銷和品牌，就賽諾菲品牌產品的未來商業化而言。

So like how would that work?

那麼這會如何運作呢？

Could you maybe shed some light on the branding message in the future?

能否透露一下未來的品牌訊息？

Thanks.

謝謝。

John T, do you want to take that question?

約翰·T，你想回答這個問題嗎？

Yeah.

是的。

I'll take the second one first, right, which is talking about what the opportunity is in the marketplace.

我先講第二個，對吧，它談論的是市場上的機會是什麼。

So as John said, we can't comment on exactly what the marketing and sales strategies are.

正如約翰所說，我們無法準確評論行銷和銷售策略。

But I think it's good to understand what the marketplace looks like today, and how the combination of our COVID vaccine with their flu vaccine could have profound opportunities in the market, as we said, both from a public health standpoint, and revenue generation.

但我認為了解當今市場的情況，以及我們的新冠疫苗與流感疫苗的結合如何在市場上帶來深遠的機遇，正如我們所說，無論是從公共衛生的角度還是創收的角度，都是有好處的。

Understanding that Sanofi is the market leader in flu vaccinations in the US around the globe.

了解賽諾菲是美國全球流感疫苗市場的領導者。

There's a clear need for a combination vaccine.

顯然需要一種聯合疫苗。

Any market assessment for combo vaccine would include what we would refer to as the cannibalization of the flu market, the leveraging of the flu market for the benefit of uptake of COVID vaccination in that combination format.

對組合疫苗的任何市場評估都將包括我們所說的流感市場的蠶食，即利用流感市場來促進以該組合形式接種新冠疫苗。

So there's a significant opportunity here with the market leader to identify what that opportunity is, and to expand vaccination rates for both COVID and flu by virtue of the combo, the vaccine.

因此，市場領導者面臨著一個重大機會，可以確定這個機會是什麼，並透過疫苗組合來擴大新冠肺炎和流感的疫苗接種率。

As we're building towards that, obviously, their position in the marketplace from a co-commercialization standpoint would be critical in helping us leverage the Sanofi brand, leverage their infrastructure, leverage their deep reach into the vaccine market and their confidence in the strength and safety and efficacy of that product, I think, says volumes about what the potential is.

在我們朝著這個目標邁進的過程中，顯然，從共同商業化的角度來看，他們在市場中的地位對於幫助我們利用賽諾菲品牌、利用他們的基礎設施、利用他們對疫苗市場的深入影響力以及他們對實力的信心至關重要。

And we see much more market -- significant market share and vaccination rate increase as a result of this relationship.

由於這種關係，我們看到了更多的市場——顯著的市場份額和疫苗接種率的增加。

And then I'm happy to take the first question regarding the breakdown and timing of the $350 million in future milestones.

然後我很高興回答第一個問題，有關未來里程碑中 3.5 億美元的細目和時間表。

So on slide number 5, we mapped it out. the expectation is that these are all near-term activities over the next 12 to 24 months.

因此，我們在第 5 張投影片上將其繪製出來。預計這些都是未來 12 至 24 個月的近期活動。

Certainly, the COVID-19 manufacturing tech transfer may take a little bit longer as we look at these, but the other ones are certainly near-term.

當然，當我們考慮這些問題時，COVID-19 製造技術轉移可能需要更長的時間，但其他技術肯定是近期的。

We're not, at this time, providing more timing on that beyond that, they're all important strategic activities that are priorities.

除此之外，我們目前不會提供更多時間安排，它們都是優先考慮的重要策略活動。

And Eric, as I said earlier, the majority of value we anticipate from this deal goes well beyond the initial $1.2 billion or $1.3 billion, to ongoing royalties of anticipated sales that Sanofi will have for our Nuvaxovid and their own combinations product.

艾瑞克，正如我之前所說，我們預計這筆交易的大部分價值將遠遠超出最初的12 億美元或13 億美元，包括賽諾菲對我們的Nuvaxovid 及其自己的組合產品的預期銷售的持續特許權使用費。

And then in addition to that, anything they may develop with Matrix-M, each individual new Matrix-M product eligible for up to $200 million in additional onetime milestones and ongoing flat royalties.

除此之外，他們可能使用 Matrix-M 開發的任何東西，每個新的 Matrix-M 產品都有資格獲得高達 2 億美元的額外一次性里程碑和持續的固定特許權使用費。

So I think it's very important to understand the different pieces of value in this deal, and why we believe it has the potential to be a multibillion dollar deal for Novavax.

因此，我認為了解這筆交易的不同價值以及為什麼我們相信它有可能成為 Novavax 數十億美元的交易非常重要。

Thank you.

謝謝。

Mayank Mamtani, B. Riley.

Mayank Mamtani，B.Riley。

Good morning team.

早上好，團隊。

Congrats on this landmark deal.

祝賀這項具有里程碑意義的交易。

And thank you for taking our question.

感謝您提出我們的問題。

Thank you, Mayank.

謝謝你，瑪雅克。

Good morning.

早安.

Yes, good morning.

是的，早安。

So glad to hear the BLA is being -- is already submitted.

很高興聽到 BLA 正在提交 - 已經提交。

Is there a PDUFA date granted yet?

PDUFA 日期已經確定了嗎？

That's my quick follow-up to the prior question.

這是我對前一個問題的快速跟進。

And then with everything in place now, the BLA plan and the FDA EUA, some pharmacy contracting, preferred settings looks like on plan.

現在一切都已就位，BLA 計劃和 FDA EUA、一些藥房承包、首選設置看起來都在計劃中。

I was just curious in your non-APA revenue guidance, which I assume is royalty revenue focused.

我只是對你們的非​​ APA 收入指南感到好奇，我認為該指南以特許權使用費收入為重點。

Could you comment on what that market share assumption might be, in that $250 million to $350 million that you have in a footnote?

您能否評論一下腳註中 2.5 億至 3.5 億美元的市佔率假設？

And then I have a couple of follow-ups.

然後我有一些後續行動。

Yes, John, why don't you take the BLA question first.

是的，約翰，為什麼不先回答 BLA 問題呢？

Yes.

是的。

Yes.

是的。

Mayank, there's a couple of pieces to the question there.

Mayank，這個問題有幾個部分。

So first of all, as you all know, we have been intending and have accomplished in fact, the submission of the BLA to FDA.

首先，正如大家所知，我們一直在打算並向 FDA 提交 BLA，事實上已經完成了。

But there was a couple of steps involved with that.

但這涉及幾個步驟。

So it was the initial approval of the BLA for the XBB strain that was under emergency use authorization last year.

因此，BLA 最初批准了去年獲得緊急使用授權的 XBB 菌株。

We were then going to be adding the prefilled syringe and the strain change into that BLA submission, and having that all tied up in a nice bow in front of the season, right?

然後我們將在 BLA 提交中添加預裝注射器和應變變化，並在賽季開始前將所有這些都綁在一個漂亮的蝴蝶結中，對吧？

While that strategy was communicated to the FDA, and it was very thoughtful about the ability for that to get us to the market on time.

雖然該策略已傳達給 FDA，但 FDA 對我們能否按時上市的能力進行了深思熟慮。

Reassessing that we in collaboration and conversations with FDA, we felt like if we focused on the strain change and we focused on the prefilled syringe, authorization that the EUA pathway would be the best way to do that, instead of the more formal BLA path.

重新評估我們與 FDA 的合作和對話，我們覺得如果我們專注於菌株變化並專注於預充式註射器，授權 EUA 途徑將是實現這一目標的最佳方式，而不是更正式的 BLA 途徑。

So as I said in the remarks, we're going to be pursuing in a parallel path.

正如我在演講中所說，我們將走一條平行的道路。

This parallel pathway ensures our timeliness to the marketplace.

這種並行途徑確保了我們進入市場的及時性。

And I think that's most critical.

我認為這是最關鍵的。

The product is authorized for use.

該產品已獲得使用授權。

There are no restrictions in how we communicate the benefits of this vaccine.

我們如何傳達這種疫苗的好處沒有任何限制。

We're going to have inventory in our 3PL distribution center in mid-August.

我們的 3PL 配送中心將於 8 月中旬有庫存。

As soon as authorization is granted, we're going to be in the market, and I think that's the most critical component of that strategy.

一旦獲得授權，我們就會進入市場，我認為這是該策略中最關鍵的組成部分。

And Mayank, as we said in our comments, and I'll hand it back to John on your market share question, and maybe, John, you could take that as the potential we see in the US marketplace, assuming we are indeed staying on track, which we are now, with our prefilled syringe in a time we launch the season.

Mayank，正如我們在評論中所說，我將把你的市場份額問題轉交給約翰，也許，約翰，你可以將其視為我們在美國市場看到的潛力，假設我們確實繼續留在美國市場賽道，我們現在正在使用我們的預裝注射器，在我們開始賽季的時候。

Because we -- Mayank, we're excited about the opportunity to perform significantly better than we did last season in the US market.

因為我們——Mayank，我們很​​高興有機會在美國市場上取得比上賽季更好的表現。

But let's address the PDUFA date question.

但讓我們解決 PDUFA 日期問題。

We will get a PDUFA date from FDA once they formally accept our file.

一旦 FDA 正式接受我們的文件，我們就會從 FDA 獲得 PDUFA 日期。

We have completed that file and are waiting for that formal acceptance.

我們已經完成了該文件，正在等待正式接受。

'

'

John, go ahead on the market share question.

約翰，繼續討論市場佔有率問題。

Yes.

是的。

So the -- yes, the PDUFA date question is part of yet another element of why the timing for EUA and BLA was critical balancing act here.

因此，是的，PDUFA 日期問題是 EUA 和 BLA 的時間安排在這裡至關重要的另一個因素的一部分。

While the FDA could act more quickly if they so desired, the PDUFA date is not the ultimate -- they don't have to fill to the PDUFA date, but it just streamline the activities in a significant way.

雖然 FDA 如果願意的話可以更快地採取行動，但 PDUFA 日期並不是最終的——他們不必填寫 PDUFA 日期，但它只是以一種重要的方式簡化了活動。

As far as market share is concerned, again, the critical elements; the new strain, prefilled syringe, on time to the market, awareness of Novavax access, some awareness and access to critical elements.

就市場佔有率而言，關鍵要素仍然是：新菌株、預充式註射器、按時上市、對 Novavax 的了解、對關鍵要素的一些認識和獲取。

We think that there's a significant opportunity in the US market, and we're going to see a dramatic shift from where we were last year.

我們認為美國市場存在重大機遇，我們將看到與去年相比發生的巨大轉變。

As you recall, in the '23 season, we relate to the market by almost a full four to five weeks, and almost 50% of the COVID market had been administered by that time.

正如您所記得的那樣，在 23 年季節，我們與市場相關了幾乎整整四到五週，到那時，幾乎 50% 的新冠病毒市場已經得到管理。

And we were also in a five-dose presentation.

我們也進行了五劑演示。

So a dramatic shift in positioning for us.

所以我們的定位發生了巨大的轉變。

And so I think there will be well established and set up for the '24 season.

所以我認為 24 賽季將會有很好的建立和準備。

Very helpful.

很有幫助。

Makes sense.

說得通。

Thank you.

謝謝。

And then on the Phase 3 CIC trial design, obviously, awesome to see the stand-alone flu added.

然後在第三階段 CIC 試驗設計中，顯然，看到添加獨立流感真是太棒了。

I was just curious since you already have control data from a Phase 3 study with NanoFlu, and I don't know if this candidate is the same as NanoFlu, but could you just talk about what the key immunogenicity objectives are being agreed upon with the FDA on the different strains and how noninferiority or superiority will have to be relative to the three arms that you're using?

我只是很好奇，因為您已經有了 NanoFlu 3 期研究的對照數據，我不知道該候選藥物是否與 NanoFlu 相同，但您能否談談與 NanoFlu 達成協議的關鍵免疫原性目標是什麼？不同菌株的評價以及相對於您正在使用的三個武器的非劣效性或優效性如何？

Yeah, Filip, why don't you take that one?

是啊，菲利普，你為什麼不拿那個？

Yeah.

是的。

So you're right.

所以你是對的。

We've tried this ground before.

我們之前已經嘗試過這個領域。

And the real difference in this is twofold.

真正的區別是雙重的。

One of them is a specific age population we're targeting.

其中之一是我們針對的特定年齡層。

Because we think that's where the medical use the greatest and is also the most lucrative market in the US at least.

因為我們認為這是醫療用途最大的地方，也是至少在美國最有利可圖的市場。

And the second one is the competitors.

第二個是競爭對手。

So the competitors we're choosing are going to position us to have commercial success going into the future.

因此，我們選擇的競爭對手將使我們在未來取得商業成功。

And I'm not going to give any more details about the specific criteria used to establish superiority or non-inferiority but certainly the non-inferiority criteria that's also well to ground, which many other sponsors have used in the past.

我不會提供有關用於確定優越性或非劣效性的具體標準的更多詳細信息，但肯定也有充分依據的非劣效性標準，許多其他申辦者過去曾使用過這些標準。

Understood.

明白了。

And lastly, I don't know if it's too early to comment, but investors care about profitability because you guys do have a real business.

最後，我不知道現在發表評論是否為時過早，但投資者關心盈利能力，因為你們確實擁有真正的業務。

So if you could talk about your expectations for breakeven given OpEx ramp down, should it continue into next year.

因此，如果您能談談在營運支出下降的情況下您對損益平衡的預期嗎？

But then obviously, you're looking to build a broad respiratory pipeline infrastructure long-term.

但顯然，您希望長期建立廣泛的呼吸管道基礎設施。

How should we think about that?

我們該如何思考這個問題？

Thank you, Mayank.

謝謝你，瑪雅克。

Go ahead, Jim.

繼續吧，吉姆。

And then we'll need to move on to the next set of questions.

然後我們需要繼續討論下一組問題。

Go ahead, Jim.

繼續吧，吉姆。

All right.

好的。

Guiding principle one.

指導原則一。

We're building an enterprise towards cash flow positive and value creation.

我們正在建立一家實現正現金流和創造價值的企業。

One of the things you heard John mention earlier is, we believe that the economics and cash flow under this agreement with Sanofi across this portfolio is, in fact, superior to the cash flow we might have been able to drive to ourselves.

您之前聽到約翰提到的一件事是，我們相信，根據與賽諾菲簽署的協議，該投資組合的經濟效益和現金流實際上優於我們自己可能獲得的現金流。

You are hearing that we are creating and driving to an important value creation platform to increase shareholder value.

您聽說我們正在創建並推動一個重要的價值創造平台，以增加股東價值。

And so we will continue to give you updates on how our business model evolves to deliver against that guiding principle.

因此，我們將繼續向您提供有關我們的業務模式如何演變以實現此指導原則的最新資訊。

Brendan Smith, TD Covance.

布倫丹史密斯，TD 科文斯。

Good morning, Brendan.

早上好，布倫丹。

Hi, good morning.

早安.

Thanks for taking the questions.

感謝您提出問題。

Huge, huge congrats.

非常非常祝賀。

It's really great to see.

真的很高興看到。

Brendan, thank you very much.

布倫丹，非常感謝你。

Appreciate it.

欣賞它。

Maybe just a quick one from us first.

也許我們先簡單介紹一下。

Apologies if I missed this, but we've been hearing a little bit from some of the COVID competitors that FDA might actually be considering authorization the updated boosters even earlier this year, possibly for August.

如果我錯過了這一點，我深表歉意，但我們從一些新冠競爭對手那裡聽說，FDA 實際上可能正在考慮在今年早些時候（可能是 8 月）授權更新的加強劑。

I wanted to see if that's been part of your conversation, do you think that would impact any of your timing or launch capabilities.

我想看看這是否是你們談話的一部分，你們認為這會影響您們的時間安排或發射能力嗎？

And then honestly, just stepping back maybe to the broader opportunity now.

老實說，現在也許只是退一步討論更廣泛的機會。

I wanted to get your thoughts on strategy and what you're thinking -- how you're thinking about each of these other non-COVID non-flu areas for you, namely like what strong you were and how you're thinking about where to go first maybe what makes sense for Novavax alone versus part of the collaboration.

我想了解您對策略的想法以及您的想法 - 您如何看待其他非新冠非流感領域，即您的實力如何以及您如何考慮哪些領域首先，也許對於Novavax 來說，與部分合作相比，這更有意義。

Thanks very much.

非常感謝。

Brendan, excellent questions.

布倫丹，問得很好。

I'll take the second question and then hand it over to John Trizzino and Filip to address your question about strain timing and launch timing for the season.

我將回答第二個問題，然後將其交給約翰·特里齊諾（John Trizzino）和菲利普（Filip）來解決您有關本賽季的應變時間和啟動時間的問題。

So when it comes to strategy, we're going to continue to crystallize our future pipeline and organic growth strategy from our own tech platform in the coming months and look forward to sharing more detail with you.

因此，在策略方面，我們將在未來幾個月內繼續透過我們自己的技術平台具體化我們未來的產品線和自然成長策略，並期待與您分享更多細節。

What we were so excited about sharing with you today was the new science that Filip and his team have been working on new data and approaches to leverage our technology in different ways for months and months now, and we unveiled some of that today to share with the investor community.

我們今天很高興與您分享的是新科學，菲利普和他的團隊幾個月來一直在研究新數據和方法，以不同的方式利用我們的技術，今天我們公佈了其中的一些內容，與大家分享投資者群。

We're still working through the best way to optimize some of those assets, and we're also considering additional early-stage assets that we can work with in our pipeline, and we intend to do so all within the new lean operating model that Jim Kelly started to outline before in his prepared comments and the questions he answered.

我們仍在努力尋找最佳方式來優化其中一些資產，我們還在考慮可以在管道中使用的其他早期資產，並且我們打算在新的精益運營模式中做到這一點，吉姆·凱利開始在他準備好的評論和他回答的問題中概述先前的內容。

So more to come on that.

所以還有更多的事情要做。

We look forward to sharing more details with you as our thoughts crystallize further, and we're ready to share them.

隨著我們的想法進一步明確，我們期待與您分享更多細節，並且我們已準備好分享它們。

So why don't I hand it over to John Trizzino and Filip to answer your first question.

那我為什麼不把它交給 John Trizzino 和 Filip 來回答你的第一個問題呢？

Right.

正確的。

So you know that the EMA have already designated a strain, and we aren't expecting the strain to be designated from the FDA until early June.

所以你知道 EMA 已經指定了一個菌株，我們預計 FDA 直到 6 月初才會指定該菌株。

And we've been in discussions with all those agencies for on a continuous basis.

我們一直在與所有這些機構進行持續的討論。

Right now, what we stated is that we're going to be submitting our supplemental filing immediately after VRBPAC.

目前，我們表示我們將在 VRBPAC 之後立即提交補充文件。

And I think that John has mentioned before, we anticipate having product available in mid-August.

我認為約翰之前提到過，我們預計產品將在八月中旬上市。

Now none of that matters as much as when the season is -- doesn't get to start by the FDA and by the CDC.

現在，這些都沒有什麼比季節何時開始更重要了——食品藥物管理局和疾病預防控制中心都沒有開始。

So that's really what we're targeting.

這確實是我們的目標。

We feel like we're in a good position to be able to achieve really whatever time frames the season starts.

我們覺得我們處於有利位置，無論賽季開始的時間如何，我們都能夠實現目標。

And John?

約翰呢？

Yeah.

是的。

I think the variability in there is they're reviewing three files simultaneously, so the FDA has a bit of work to do.

我認為其中的可變性是他們同時審查三個文件，因此 FDA 有一些工作要做。

I think they've already signaled that they're going to have a formal campaign kick-off, post the Labor Day holiday in the US and there's going to be a readiness in front of that.

我認為他們已經發出信號，表示將在美國勞動節假期後正式啟動競選活動，並在此之前做好準備。

As we said, we're going to have product availability in the warehouse.

正如我們所說，我們將在倉庫中提供產品。

It might even be queued up at the distributors or even an staging, awaiting that campaign to kick off.

它甚至可能在經銷商排隊，甚至在舞台上等待活動開始。

But I think the timing is -- it makes a lot of sense, right?

但我認為這個時機很有意義，對吧？

We're coming out of the summer vacation period.

我們即將度過暑假。

We're coming back to school, back to work, the CDC's campaign, the other competitors' campaigns will begin kicking in that September 1 -- 1st week in September time frame.

我們要回到學校，回到工作崗位，疾病預防控制中心的活動，其他競爭對手的活動將在 9 月 1 日——9 月時間框架的第一周開始啟動。

And so we're synchronized around that.

所以我們對此保持同步。

Yes.

是的。

And finally, Brendan, and we'll take final questions next.

最後，布倫丹，我們接下來將回答最後一個問題。

But finally, to build on John's point earlier, that's another reason for the dual pathway for regulatory authorizations this year, the BLA and the EUA John mentioned because it gives us a chance to have -- to be more nimble and more quick through the EUA pathway with our prefilled syringe and the updated strains.

但最後，以約翰先前的觀點為基礎，這是今年監管授權雙重途徑的另一個原因，約翰提到了 BLA 和 EUA，因為它讓我們有機會更靈活、更快速地通過 EUA我們的預裝注射器和更新的菌株的途徑。

We believe we'll be ready and we're excited about the opportunity in the US this Fall.

我們相信我們會做好準備，我們對今年秋天在美國的機會感到興奮。

One last comment when you asked about portfolio, I just want to make sure everyone is clear, that we have a wholly owned independent portfolio and that our combination influenza COVID vaccine is completely ours and completely independent from the vaccine that Sanofi will develop in their pipeline, using our Nuvaxovid.

最後一點，當您詢問產品組合時，我只是想確保每個人都清楚，我們擁有全資獨立的產品組合，並且我們的聯合流感新冠疫苗完全是我們自己的，並且完全獨立於賽諾菲將在其管道中開發的疫苗，使用我們的 Nuvaxovid。

Just want to make sure that, that's clear to everybody.

只是想確保每個人都清楚這一點。

Thank you.

謝謝。

And we'll take a final questions, Erika, from the final analyst.

艾莉卡，我們將從最終分析師那裡提出最後一個問題。

Vernon Bernardino, H.C. Wainwright.

伯納迪諾，H.C.溫賴特。

Hi, everyone.

大家好。

And congratulations from me also.

我也表示祝賀。

And thanks for taking my question.

感謝您提出我的問題。

I think one thing that needs to be mentioned is, I think you've found a great partner because you both are advancing protein-based vaccines.

我認為需要提及的一件事是，我認為你們找到了一個很好的合作夥伴，因為你們都在推動蛋白質為基礎的疫苗。

I think that's nothing to be recognized.

我認為這沒什麼好承認的。

Question I have, just like other analysts and what we tend to do is a three-part question, but maybe it's just only two now.

我的問題是，就像其他分析師一樣，我們傾向於做一個由三個部分組成的問題，但現在可能只有兩個部分。

Regarding the combination vaccine, is there any consideration as far as Sanofi side that you'll need to have a BLA approved flu vaccine or COVID vaccine for them to actually progress the work on a combination vaccine, that includes their quadrivalent flu vaccine.

關於聯合疫苗，賽諾菲是否考慮過需要 BLA 批准的流感疫苗或 COVID 疫苗，以便他們可以真正推進聯合疫苗（包括四價流感疫苗）的工作。

And then as a follow-up to that, I was just wondering, obviously, the vaccine does not have Matrix-M.

然後作為後續行動，我只是想知道，顯然，疫苗沒有 Matrix-M。

I was wondering if you could remind us the comparison of the quadrivalent versus yours Fluvax for example.

我想知道你能否提醒我們四價藥物與你們的 Fluvax 的比較。

And with their potential to add Matrix-M to their quadrivalent, what expectancy enhancement do you think they could actually achieve?

由於他們有潛力將 Matrix-M 添加到四價中，您認為他們實際上可以實現多少預期增強？

Thank you.

謝謝。

Yeah.

是的。

Vernon, I'll hand the question over to Filip.

佛農，我會把問題交給菲利普。

Excellent questions.

很好的問題。

We're not going to comment on Sanofi's particular technology platform.

我們不會評論賽諾菲的特定技術平台。

But Filip, do you want to address the questions about the BLA?

但是 Filip，你想回答有關 BLA 的問題嗎？

Yeah.

是的。

Their regulatory path will really involve a standalone BLA.

他們的監管路徑實際上將涉及獨立的 BLA。

So in that regard, it doesn't really rely on our regulatory process with Nuvaxovid alone.

因此，在這方面，它並不真正依賴我們對 Nuvaxovid 的監管流程。

So they're going to put together a package, which has to show that their combination of their flu vaccine plus Nuvaxovid is safe and efficacious.

因此，他們將製作一個包裝，必須證明他們的流感疫苗和 Nuvaxovid 的組合是安全有效的。

And the approach they take, is it going to be really up for them to define and to get approval with the regulators.

他們採取的方法是否真的要由他們來定義並獲得監管機構的批准。

Perfect.

完美的。

And you won't be able to comment on what you think the addition of metric to Sanofi's flu quadrivalent could be?

您將無法評論您認為在賽諾菲的流感四價中添加公制可能是什麼？

No, we're not going to comment on that today, Vernon.

不，我們今天不會對此發表評論，弗農。

Okay.

好的。

That is all the questions and congratulations.

這就是所有的問題和祝賀。

Thank you.

謝謝。

Thank you, Vernon and one comment to thank you for asking.

謝謝你，弗農，並發表一條評論來感謝你的詢問。

And importantly, again, we don't want anyone to walk away without total clarity that this deal has tremendous value, multibillion-dollar potential deal for Novavax.

再次重要的是，我們不希望任何人在沒有完全明確這筆交易對 Novavax 而言具有巨大價值、潛在價值數十億美元的情況下就走開。

Including the upfront payments of the $1.3 billion and then well beyond that anticipated royalties of significant value, we think even greater value than those upfront payments.

包括 13 億美元的預付款以及遠遠超出預期的巨大價值的特許權使用費，我們認為比這些預付款的價值更大。

And then on top of that, to your point, Vernon, what they could do with Matrix-M, and we think there's immense potential with Sanofi as a powerhouse in vaccine development and commercialization, and we're very excited about some of the concepts and ideas they may be contemplating about what to do with Matrix-M.

最重要的是，Vernon，就你的觀點而言，他們可以用Matrix-M 做什麼，我們認為賽諾菲作為疫苗開發和商業化的強大力量具有巨大的潛力，我們對其中的一些概念感到非常興奮以及他們可能正在考慮如何使用 Matrix-M 的想法。

And with each new Matrix-M product they would choose to bring forward should they do so.

如果他們這樣做的話，他們會選擇推出每個新的 Matrix-M 產品。

We have the potential for up to $200 million in onetime milestones, and ongoing flat royalty for years to come.

我們有可能在一次性里程碑中獲得高達 2 億美元的收入，並在未來幾年內持續維持固定特許權使用費。

So those pieces of value are absolutely critical, and that's what makes this deal well beyond the upfront milestones and payments that everyone has been talking about a multibillion-dollar deal we feel for Novavax.

因此，這些價值絕對至關重要，這就是使這筆交易遠遠超出了我們對 Novavax 的數十億美元交易的預付款里程碑和付款的原因。

Thank you so much everyone for your questions.

非常感謝大家的提問。

Erika, I'll turn it back to you and then the operator to close.

艾莉卡，我會將其轉回給您，然後接線員關閉。

This concludes our question-and-answer session.

我們的問答環節到此結束。

I would like to turn the conference back over to John Jacobs for any closing comments.

我想將會議轉回約翰·雅各布斯（John Jacobs）以徵求結束意見。

No.

不。

Thank you, everyone.

謝謝大家。

Thank you for joining us today.

感謝您今天加入我們。

We appreciate your time.

我們感謝您的寶貴時間。

We'll keep working with humility, diligence and all of our efforts to return value to our loyal shareholders.

我們將繼續謙虛、勤奮，竭盡全力為忠誠的股東回報價值。

And I want to thank all of our employees at Novavax for their time, energy and effort to get us to this next stage in the beginning of a new chapter for the future of our company.

我要感謝 Novavax 的所有員工付出的時間、精力和努力，讓我們進入下一階段，開啟公司未來的新篇章。

Thank you, everyone for joining us today.

謝謝大家今天加入我們。

The conference has now concluded.

會議現已結束。

Thank you for attending today's presentation.

感謝您參加今天的演講。

You may now disconnect.

您現在可以斷開連線。

Thank you.

謝謝。