Novavax Inc (NVAX) 2025 Q1 法說會逐字稿

Good morning and welcome to Novavax's first quarter 2025 financial results and operational highlights conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the start key followed by 0. After today's presentation, there will be an opportunity to ask questions. That's a question, you may press star, followed by the number 1 on your touchstone form. To withdraw your question, please press star, followed by number 2. Please note, this event is being recorded. I would now like to turn the conference over to Luis Sanay, Vice President, investor relations. Please go ahead.

早安，歡迎參加 Novavax 2025 年第一季財務業績及營運亮點電話會議。所有參與者將處於只聽模式。如果您需要協助，請按開始鍵然後按 0 向會議專家發出信號。今天的演講結束後，將有機會提問。這是一個疑問句，您可以在您的標準表格上按星號，然後按數字 1。若要撤回您的問題，請按星號，然後按數字 2。請注意，此事件正在被記錄。現在，我想將會議交給投資人關係副總裁 Luis Sanay。請繼續。

Good morning and thank you all for joining us today to discuss our first quarter of 2025 financial results and operational highlights. A press release announcing our results is currently available on our website at Novavax.com, and an audio archive for this conference call will be available on our website later today. Please turn to slide 2.

早安，感謝大家今天加入我們，討論我們 2025 年第一季的財務表現和營運亮點。目前，我們的網站 Novavax.com 上已發布一份宣布我們研究結果的新聞稿，今天晚些時候，我們的網站上也將提供本次電話會議的音訊存檔。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 but not limited to statements related to Novavax's corporate strategy and operating plans, its strategic priorities, its partnerships, and expectations with respect to potential royalties, milestones, and cost reimbursements, FDA approval of the company's COVID-19 vaccine BLA, and alignment on the post marketing commitment. Its expectations regarding manufacturing capacity, timing, production, and delivery for its COVID-19 vaccine, the development of Novavax's clinical and preclinical product candidates, full year 2025 financial guidance and revenue framework, and Novavax's future financial business performance.

在我們開始準備好的發言之前，我需要提醒您，本簡報包含前瞻性陳述，包括但不限於與 Novavax 的公司策略和營運計劃、策略重點、合作夥伴關係以及對潛在特許權使用費、里程碑和成本報銷、FDA 對該公司 COVID-19 疫苗 BLA 的批准以及對上市後承諾的一致性的期望有關的陳述。其對 COVID-19 疫苗的生產能力、時間、生產和交付的預期、Novavax 臨床和臨床前候選產品的開發、2025 年全年財務指導和收入框架以及 Novavax 未來財務業務表現的預期。

Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding these factors appears under the heading cautionary note regarding forward-looking statements in the presentation we issued this morning and under the heading Risk factors in our most recent Form 10K and subsequent Form 10Qs filed with the Securities and Exchange Commission available at SEC.gov and on our website at Novavax.com.

本簡報中包含的每個前瞻性陳述都受風險和不確定性的影響，這些風險和不確定性可能導致實際結果與此類陳述中預測的結果有重大差異。有關這些因素的更多信息，請參閱我們今天上午發布的演示文稿中有關前瞻性陳述的警示說明標題下，以及我們向美國證券交易委員會提交的最新 10K 表和後續 10Q 表中的風險因素標題下，這些表格可在 SEC.gov 和我們的網站 Novavax.com 上查閱。

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. Please turn to slide 3. This presentation also includes references to non-gap financial measures which are total adjusted revenue and adjusted licensing, royalties, and other revenue, and non-gap profitability.

本簡報中的前瞻性聲明僅代表本簡報原始日期的觀點，我們不承擔更新或修改任何這些陳述的義務。請翻到幻燈片 3。本簡報還包括對非差距財務指標的引用，即總調整收入和調整後的授權、特許權使用費和其他收入以及非差距獲利能力。

Please turn to slide 4. Joining me today is John Jacobs, our President and CEO, who will provide an update on our progress during the quarter and highlight our growth strategy. Dr. Ruxandra Draghia, head of R&D, will discuss our R&D updates, and finally, Jim Kelly, Chief Financial Officer and treasurer, will provide an overview of our financial results and 2025 financial guidance and revenue framework. John Trezino, Chief Operating Officer, will be available for the Q&A portion of the coal. I would now like to hand over the call to John Jacobs.

請翻到幻燈片 4。今天與我一起出席的是我們的總裁兼執行長約翰·雅各布斯 (John Jacobs)，他將介紹我們本季的進展並強調我們的成長策略。研發主管 Ruxandra Draghia 博士將討論我們的研發更新，最後，財務長兼財務主管 Jim Kelly 將概述我們的財務表現和 2025 年財務指導和收入架構。營運長 John Trezino 將出席煤炭問答環節。現在我想把電話交給約翰·雅各布斯。

Thank you, Luis. I'm pleased to be here with you today along with members of our executive team to discuss our financial results and highlight the progress we have made in Q1. This earnings call marks approximately the one-year anniversary of our new corporate growth strategy, which was formed after signing our agreement with Sanofi. Over the course of the past year, we have moved away from our prior focus, which was allocating the majority of our time, energy, and resources on commercializing our COVID-19 vaccine. To a strategy focused on optimizing our existing partnerships and expanding access to our proven technology platform via R&D innovation, organic portfolio expansion, and forging new partnerships and collaborations with other companies.

謝謝你，路易斯。我很高興今天能與我們的執行團隊成員一起在這裡討論我們的財務表現並強調我們在第一季度取得的進展。本次財報電話會議標誌著我們與賽諾菲簽署協議後形成的新的企業成長策略的實施一周年。在過去的一年裡，我們不再像以前那樣將大部分時間、精力和資源投入 COVID-19 疫苗的商業化。該策略的重點是優化我們現有的合作夥伴關係，並透過研發創新、有機產品組合擴展以及與其他公司建立新的合作夥伴關係和合作關係來擴大我們成熟技術平台的訪問。

We believe this strategy enables maximum value creation from our cutting-edge technology. In parallel, we are creating a significantly leaner infrastructure with continued cost reduction initiatives underway as we drive towards potential non-gap profitability as early as 2027 via our new strategy, we intend to create multiple opportunities for value growth. Important catalysts this year include the potential approval of the BLA for our COVID vaccine and other milestones related to the Sanofi agreement, pre-clinical data from our early-stage pipeline programs in the second half of this year, and the potential for additional partnerships and collaborations.

我們相信這項策略能夠讓我們的尖端技術創造最大價值。同時，我們正在創建一個更精簡的基礎設施，並持續實施成本削減計劃，透過我們的新策略，我們力爭最早在 2027 年實現潛在的無差距盈利，我們打算創造多種價值增長機會。今年的重要催化劑包括我們的 COVID 疫苗 BLA 可能獲得批准以及與賽諾菲協議相關的其他里程碑、今年下半年我們早期管道項目的臨床前數據以及建立更多夥伴關係和合作關係的可能性。

As an example, we are excited about the progression of our partnership with Takeda as it significantly improves the financial terms for Novavax in Japan, the 3rd largest healthcare market in the world. This strengthened partnership with Takeda, a globally respected multinational pharmaceutical company, further validates the value of our cutting-edge technology platform and our efforts to become a partner of choice.

例如，我們對與武田的合作進展感到非常興奮，因為它顯著改善了 Novavax 在全球第三大醫療保健市場日本的財務狀況。與全球知名跨國製藥公司武田加強合作，進一步驗證了我們尖端技術平台的價值以及我們成為首選合作夥伴的努力。

Forging new collaborations and partnerships based on our differentiated tech platform and deep expertise in vaccine development is a top priority for us this year. And we look forward to sharing partnership updates with you as we continue to execute upon this key strategic pillar for Novavax.

基於我們差異化的技術平台和疫苗開發方面的深厚專業知識，建立新的合作夥伴關係是我們的今年的首要任務。我們期待與您分享合作關係的最新進展，並將繼續執行 Novavax 的這一關鍵策略支柱。

To guide our work for the remainder of 2025, we remain focused on three strategic priorities. Our first priority is optimizing our partnership with Sanofi. Our partnership with Sanofi is a prime example of how we intend to work with others as we look to become a partner of choice and create long-term value for our stakeholders. As we have said before, this partnership has many important and potentially value creating elements to it, including milestones and royalties associated with the marketing of our COVID vaccine related to the BLA approval, MAH transfers, tech transfer, and ongoing royalties. Number 2, milestones and royalties associated with the development of new combination vaccines that include our COVID vaccine.

為了指導我們 2025 年剩餘時間的工作，我們將繼續專注於三個策略重點。我們的首要任務是優化與賽諾菲的合作關係。我們與賽諾菲的合作是我們希望與其他公司合作的典型例子，我們希望成為首選合作夥伴並為我們的利害關係人創造長期價值。正如我們之前所說，這種合作關係具有許多重要且可能創造價值的元素，包括與 BLA 批准相關的 COVID 疫苗行銷的里程碑和特許權使用費、MAH 轉讓、技術轉移和持續的特許權使用費。第二，與包括我們的 COVID 疫苗在內的新型組合疫苗開發相關的里程碑和特許權使用費。

For example, Sanofi is developing two combination vaccines that include our COVID vaccine and their market leading flu vaccines, both of which earned fast track designation from the FDA last year. And finally, milestones and royalties associated with any other new products developed using our matrix-M adjuvant. Regarding our COVID vaccine, we are working constructively with the FDA with the intent of bringing the BLA process to a positive conclusion as soon as possible. FDA feedback on RBLA suggests a pathway to approval upon alignment on study parameters for the post marketing commitment requested.

例如，賽諾菲正在開發兩種聯合疫苗，包括我們的 COVID 疫苗和其市場領先的流感疫苗，這兩種疫苗去年都獲得了 FDA 的快速通道資格。最後，使用我們的 matrix-M 佐劑開發的任何其他新產品的里程碑和特許權使用費。關於我們的 COVID 疫苗，我們正在與 FDA 進行建設性合作，旨在盡快使 BLA 流程取得積極成果。FDA 對 RBLA 的回饋建議，在研究參數與所要求的上市後承諾一致的情況下，可以採取一種途徑來獲得批准。

We believe it's important that a non-mRNA protein-based COVID-19 vaccine option is available as a choice for US consumers. Our second strategic priority is to leverage our proven tech platform and pipeline to drive additional partnerships. Our team has been actively working on developing new partnership opportunities beyond Sanofi and the Material Transfer Agreement, or MTA with the top tier pharma company that we announced last fall to explore our matrix-M adjuvant with bacterial pathogens. In fact, over the past few months we have signed new agreements, including an expanded scope of the MTA I just mentioned to now include viral pathogens.

我們認為，為美國消費者提供非 mRNA 蛋白的 COVID-19 疫苗選擇非常重要。我們的第二個策略重點是利用我們成熟的技術平台和管道來推動更多的合作關係。我們的團隊一直在積極致力於開發新的合作機會，除了賽諾菲和材料轉讓協議（MTA）之外，我們還與去年秋天宣布的頂級製藥公司合作，探索針對細菌病原體的基質-M 佐劑。事實上，在過去的幾個月裡，我們簽署了新的協議，包括我剛才提到的擴大 MTA 的範圍，現在包括病毒病原體。

We signed another new MTA for Matrix-M with a different top-tier pharma company entered a pre-clinical collaboration with a new partner to explore the application and utility of Matrix-M with their cancer vaccine candidate and as noted earlier, strengthened our existing agreement with Takata for the COVID market in Japan, including significantly improved financial terms for Novavax. These new agreements represent important steps in our continuing quest to add new partnerships throughout licensing efforts and further highlight the growing interest in our tech platform.

我們與另一家頂級製藥公司簽署了另一份新的 Matrix-M MTA，與一家新合作夥伴開展了臨床前合作，探索 Matrix-M 在其癌症候選疫苗中的應用和效用，並且如前所述，加強了我們與高田在日本 COVID 市場的現有協議，包括顯著改善 Novavax 的財務條款。這些新協議代表了我們在授權工作中不斷尋求增加新合作夥伴關係的重要一步，並進一步凸顯了人們對我們的技術平台日益增長的興趣。

We intend to optimize these new agreements with the goal of expanding the scope and value creation opportunity for each of them over time. And we don't intend to stop here. We are actively seeking additional partnerships and collaborations with the goal of creating multiple growth opportunities in the short, mid and long term for Novavax. As we stated before, this ongoing effort includes seeking a potential partner to develop and commercialize our latest COVID influenza combination vaccine and standalone flu vaccine.

我們打算優化這些新協議，目標是隨著時間的推移擴大每個協議的範圍和價值創造機會。但我們並不打算就此止步。我們正在積極尋求更多的合作關係，目標是為 Novavax 在短期、中期和長期創造多種成長機會。正如我們之前所說，這項持續的努力包括尋找潛在的合作夥伴來開發和商業化我們最新的 COVID 流感聯合疫苗和獨立流感疫苗。

And finally, our third strategic priority is to advance our tech platform and early-stage pipeline. We are actively advancing our early-stage pipeline programs using a capital efficient approach. Our R&D investment strategy should allow us to make disciplined investments in programs aligned to the highest potential value opportunities both within infectious disease and beyond. Our intent is to partner these assets at early proof of concept stages. However, for the right asset where data and commercial landscape indicate a unique high value opportunity. We would consider bringing that asset forward ourselves and we'll make that determination on a case-by-case basis as these assets mature.

最後，我們的第三個策略重點是推動我們的技術平台和早期階段的研發管線。我們正在採用資本高效的方式積極推進我們的早期管道計劃。我們的研發投資策略應該使我們能夠對與傳染病領域及其他領域中最高潛在價值機會相符的項目進行有紀律的投資。我們的目的是在概念驗證的早期階段將這些資產結合起來。然而，對於正確的資產，數據和商業前景表明存在獨特的高價值機會。我們會考慮自己將該資產提前，並且會根據這些資產的成熟情況逐案做出決定。

A bit later in the call, Roxandra will talk about how we're using translational research and computational medicine to inform these investment decisions. We anticipate sharing some initial data on our new pipeline assets and new data on Matrix-M and our technology platform in the second half of the year during an investor day.

在稍後的電話會議中，Roxandra 將談論我們如何利用轉化研究和計算醫學來指導這些投資決策。我們預計將在今年下半年的投資者日期間分享有關我們的新管道資產的一些初步數據以及有關 Matrix-M 和我們的技術平台的新數據。

In summary, over the past few months we have made significant progress with our new growth strategy, including the addition of new agreements with other companies. The expansion and strengthening of existing agreements with two major pharma companies. The initiation of 4 new early-stage pipeline programs and the continued advancement of our partnership with Sanofi. We remain confident that over the long run our technology has the opportunity to positively impact on the lives of billions of people around the world. That our strategy has the potential to drive significant value creation and that our team Has the knowledge, poise and skill to help carry us forward to an exciting and positive future for Novavax. I would now like to turn the call to Roxandra to discuss our research and development updates. Roxandra.

總而言之，在過去的幾個月裡，我們的新成長策略取得了重大進展，包括與其他公司達成了新的協議。擴大並加強與兩家大型製藥公司的現有協議。啟動4個新的早期研發管線項目，並持續推動與賽諾菲的合作。我們堅信，從長遠來看，我們的技術有機會對全球數十億人的生活產生積極影響。我們的策略有潛力推動重大價值創造，我們的團隊擁有知識、沉著和技能，可以幫助我們為 Novavax 創造一個令人興奮和積極的未來。現在我想把電話轉給 Roxandra，討論一下我們的研究和開發更新。羅克珊德拉。

Thank you, John. Please turn to slide 6. It has been 6 months since joining Novavax's innovative R&D team, and this time left me even more excited about the potential of our technology platform and the opportunity we have to strengthen and build on the depth and breadth of our partnerships. As John mentioned before, an important part of our corporate growth strategy is value creation, through the advancement of our early-stage pipeline and high-quality R&D.

謝謝你，約翰。請翻到幻燈片 6。加入 Novavax 創新研發團隊已經 6 個月了，這段時間我對我們的技術平台的潛力以及我們加強和拓展合作夥伴關係的深度和廣度的機會更加興奮。正如約翰之前提到的，我們企業成長策略的一個重要部分是透過推動早期產品線和高品質的研發來創造價值。

Value comes in different shapes and sizes. It starts in the lab, advancing programs and learnings in a continuous cycle of generating scientific data, which in turn informs next projects and experiments with the goal of developing new vaccines and positively impacting public health. We have already accomplished a lot in a short time frame, and I'm encouraged and inspired by the depth, expertise and skills of our team.

價值有不同的形狀和大小。它始於實驗室，在不斷生成科學數據的循環中推進項目和學習，進而為下一個項目和實驗提供信息，目標是開發新疫苗並對公共健康產生積極影響。我們在短時間內已經取得了許多成就，我們團隊的深度、專業知識和技能讓我感到鼓舞和啟發。

Since the start of the year, we initiated and advanced 4 early-stage programs after a rigorous prioritization process H5N1, RSV combinations, shingles, and CDVCL using information from translational models and leveraging, artificial intelligence and machine learning. Furthermore, we continued our research into our COVID-19 vaccine and progressed our latest programs in kick and flu.

自今年年初以來，我們利用轉化模型的資訊以及人工智慧和機器學習，經過嚴格的優先排序過程，啟動並推進了 4 個早期項目，即 H5N1、RSV 組合、帶狀皰疹和 CDVCL。此外，我們繼續進行 COVID-19 疫苗的研究，並推進了針對流感的最新計畫。

Please turn to slide 7. We also continue to explore Matrix-M and its potential impact across a variety of vaccine platforms and pathogens, including new formulation of Matrix-M, generating data that demonstrate the utility of our adjuvants, ensuring that with potential BD partners. Another example of us leading the way with science. In April, I presented at the World Vaccine Congress on the potential of Novavax's platform technology and matrix-M adjuvant showcasing attributes related to efficacy and tolerability. Data collected and analyzed from multiple clinical trials show that vaccines aggravated with matrix M. Have a milder reactogenicity profile compared to mRNA vaccines.

請翻到幻燈片 7。我們也將繼續探索 Matrix-M 及其對各種疫苗平台和病原體的潛在影響，包括 Matrix-M 的新配方，產生證明我們佐劑效用的數據，確保與潛在的 BD 合作夥伴合作。我們以科學引領潮流的另一個例子。四月份，我在世界疫苗大會上介紹了 Novavax 平台技術和 matrix-M 佐劑的潛力，展示了與功效和耐受性相關的屬性。從多個臨床試驗收集和分析的數據表明，與 mRNA 疫苗相比，基質 M 加重的疫苗具有更溫和的反應原性。

Please turn to slide 8. Furthermore, we presented the results of the SHIELD study at the Congress of the European Society of Clinical Microbiology and Infectious Disease Conference. This real-world study demonstrated that our protein-based technology platform outperformed one of the mRNA COVID vaccines across all parameters measured in terms of fewer and less. Severe reactogenicity symptoms with approximately 39 fewer symptoms on average and reduce the impact of the symptoms on quality of life such as daily work and family responsibilities. We believe that real world information showing that a better tolerability and a milder reactogenicity profile will lead people to prefer our protein-based technology over other vaccine platforms when given the choice.

請翻到第 8 張投影片。此外，我們在歐洲臨床微生物學和傳染病學會大會上展示了SHIELD研究的結果。這項真實世界的研究表明，我們的基於蛋白質的技術平台在所有以更少和更少為衡量標準的參數上都優於一種 mRNA COVID 疫苗。嚴重的反應原性症狀平均減少約39種症狀，並減少症狀對日常工作和家庭責任等生活品質的影響。我們相信，現實世界的資訊表明，更好的耐受性和更溫和的反應原性將使人們在有選擇時更喜歡我們的基於蛋白質的技術，而不是其他疫苗平台。

In early studies we are seeking to explore how neuroma matrix-M formulations, different regimens, and dosing schedules and other enhancements to Matrix M and its components could lead to improved vaccines, personalized approaches, and advancement in therapeutic areas beyond infectious diseases. As an example, we are currently developing research partnerships and collaboration in immune oncology, a field that is rapidly progressing and one where we envision exciting potential opportunities for our technology. By taking targeted risks, we expect to identify specific areas where matrix-M. Either as currently formulated or as a next generation formulation, has the potential to improve rates and duration of anti-tumor responses.

在早期研究中，我們試圖探索神經瘤基質-M 配方、不同方案和給藥時間表以及基質 M 及其成分的其他增強功能如何能夠改進疫苗、個人化治療方法以及在傳染病以外的治療領域取得進步。例如，我們目前正在發展免疫腫瘤學領域的研究夥伴關係和合作，這是一個快速發展的領域，我們預見到我們的技術將在這個領域擁有令人興奮的潛在機會。透過承擔有針對性的風險，我們希望確定矩陣-M 的具體領域。無論是目前的配方還是下一代配方，都有可能提高抗腫瘤反應的速度和持續時間。

Please turn to slide 9. We have previously reported that we developed a protein nanoparticle, a matrix M vaccine against highly pathogenic avian H5N1 virus that is currently undergoing pre-clinical evaluation. Non-human primate studies have shown our candidate vaccine can produce protective levels of immunity after a single dose in primed animals, a situation like that of the human population which received the flu vaccine or had influenza in the past. A little mirroring challenge model showed complete protection in a similar vaccination regimen. Like other vaccines which might require 2 or more doses for full protection, the possibility to administer a single vaccine dose for protection is important in the context of a pandemic, both in the United States and globally.

請翻到第 9 張投影片。我們之前曾報導過，我們開發了一種蛋白質奈米顆粒，一種針對高致病性禽流感病毒H5N1的基質M疫苗，目前正在進行臨床前評估。非人類靈長類動物研究表明，我們的候選疫苗在接種過一次疫苗的動物身上就能產生保護性免疫水平，這種情況類似於接種過流感疫苗或過去患過流感的人類群體。小型鏡像挑戰模型表明，在類似的疫苗接種方案中可以獲得完全的保護。與其他可能需要 2 劑或更多劑才能獲得完全保護的疫苗一樣，在美國和全球大流行的背景下，僅接種一劑疫苗即可獲得保護的可能性非常重要。

Furthermore, additional exploratory data in the context of our COVID vaccine have shown that our technology platform can induce mucosal antibodies. Muucosal protection is important not only for the person receiving the vaccine, but for instance for reducing virus transmission. Elements of our vaccine platform, its design, scale up, and manufacturing processes should make a pandemic flu vaccine from Novavax amenable to rapid deployment as an alternative to mRNA vaccines. We stand ready to join the United States in global health security efforts related to H5N1 and are currently pursuing funding and partnership opportunities for this program.

此外，我們在 COVID 疫苗方面的額外探索性數據表明，我們的技術平台可以誘導黏膜抗體。黏膜保護不僅對接種疫苗的人很重要，而且對於減少病毒傳播也很重要。我們的疫苗平台的要素、設計、擴大規模和製造流程應該使得 Novavax 的大流行性流感疫苗能夠作為 mRNA 疫苗的替代品快速部署。我們隨時準備加入美國在應對 H5N1 病毒的全球衛生安全努力中，目前正在為該計畫尋求資金和合作機會。

Our new programs across our discovery portfolio are using artificial intelligence and machine learning enabled, structure driven optimization, rapid antibody testing for epitope assessment, and novel in vitro and in vivo models for rapid preclinical testing. Our early-stage pipeline includes the development of an RSV combination vaccine candidate that builds on the company's extensive history in this area.

我們發現的產品組合中的新項目正在使用人工智慧和機器學習、結構驅動優化、用於表位評估的快速抗體測試以及用於快速臨床前測試的新型體外和體內模型。我們的早期研發管線包括開發呼吸道合胞病毒 (RSV) 組合候選疫苗，該疫苗以該公司在該領域的豐富歷史為基礎。

Lessons learned regarding superior protein antigen design together with the new computational capabilities mentioned before should allow us to enhance structural stability and immunogenicity and combine multiple different respiratory virus antigens with matrix-M into this program. Potentially created a competitive, meaningful, and differentiated offering in this key area. For shingles prevention, we believe our technology has the potential to improve on the current standard of care by enabling a more tolerable, less reactogenic, equally efficacious vaccine.

關於優質蛋白質抗原設計的經驗教訓以及前面提到的新的計算能力應該使我們能夠增強結構穩定性和免疫原性，並將多種不同的呼吸道病毒抗原與基質-M結合到這個程序中。有可能在這一關鍵領域創造出具有競爭力、意義重大且差異化的產品。對於帶狀皰疹的預防，我們相信我們的技術有潛力透過生產出耐受性更強、反應原性更低、同樣有效的疫苗來改善目前的護理標準。

Many at risk adults are declining shingles protections or don't complete their vaccination series because of the fear of side effects. By providing a more attractive option regarding tolerability, which we believe our technology has the potential to do, we intend to change this dynamic and address a persistent public health need. We believe our technology may lead to better vaccine candidates for the prevention of difficile, morbidity, and mortality. There is no approved vaccine for CD, yet the medical need is large, with Cd-related illness, including recurrent infection. Our technology has the potential to facilitate the development of a multivalent aggravated vaccine with enhanced activity that could provide a differentiated impact in an underserved patient population.

許多高風險成年人由於害怕副作用而拒絕接種帶狀皰疹疫苗或沒有完成疫苗接種。透過提供更具吸引力的耐受性選擇（我們相信我們的技術有潛力做到這一點），我們打算改變這種狀況並滿足持續的公共衛生需求。我們相信，我們的技術可能帶來更好的疫苗候選物，以預防艱難梭菌感染、發病率和死亡率。目前尚無核准的CD疫苗，但CD相關疾病（包括復發性感染）的醫療需求很大。我們的技術有可能促進具有增強活性的多價加重疫苗的開發，從而為服務不足的患者群體提供差異化的影響。

We expect to share some initial data and early learnings on our early-stage organic pipeline during the second half of the year. Turning to our late stage and standalone flu programs, in December 2024, we started an initial cohort of a phase 3 immunogenicity and safety trial for our kit and standalone influenza vaccine candidates in older adults. This trial completed enrollment of approximately 2000 participants, and we are on track to report topline data midyear. While not a pivotal study, this data will be essential to inform the design of a subsequent pivotal trial in older adults for both programs.

我們預計將在今年下半年分享一些有關我們早期有機管道的初步數據和早期經驗。談到我們的後期和獨立流感項目，2024 年 12 月，我們開始在老年人中對我們的試劑盒和獨立流感疫苗候選物進行 3 期免疫原性和安全性試驗的初始隊列。此次試驗已招募約 2000 名參與者，我們預計在年中報告頂線數據。雖然這不是一項關鍵研究，但這些數據對於這兩個計畫後續針對老年人的關鍵試驗的設計至關重要。

In addition, after further consultation with the US FDA, we determined that seeking an accelerated approval pathway for either of these assets would not be feasible. We intend to partner both vaccine programs and have the potential partner advance and fund all future clinical development, regulatory filing, and commercialization activities. In summary, now with an intense focus on science and readiness for partnering, we intend to advance and optimize our programs and generate initial proof of concept in pre-clinical evaluations. I'm very much looking forward to sharing with you some of our first data readouts in the second half of this year. I'll turn the call over to Jim to discuss our financial results.

此外，在與美國 FDA 進一步協商後，我們認為為這兩項資產尋求加速審批途徑都是不可行的。我們打算與這兩個疫苗計畫合作，並讓潛在的合作夥伴推進和資助所有未來的臨床開發、監管備案和商業化活動。總之，現在我們高度重視科學和合作準備，我們打算推進和優化我們的項目，並在臨床前評估中產生初步的概念證明。我非常期待在今年下半年與大家分享我們一些第一批的數據讀數。我將把電話轉給吉姆來討論我們的財務結果。

Well, thank you, Roxandra. Please turn to slide 10. This morning, we announced our financial results for the first quarter of 2025. Details of our results can be found in our press release issued today and in our Form 10 filed with the SEC. Before reviewing our financial results, I would like to begin by noting that today we are reiterating our financial guidance for full year 2025 combining R&D and SG&A expenses and raising our 2025 revenue framework. Last quarter we outlined Novavax's path to significant value creation and potential non-gap profitability, and we are focused on the execution of this plan. More on these points later in my remarks.

好吧，謝謝你，Roxandra。請翻到第 10 張投影片。今天上午，我們公佈了2025年第一季的財務表現。我們的結果詳情可以在我們今天發布的新聞稿和向美國證券交易委員會提交的 10 號表格中找到。在回顧我們的財務表現之前，我想先指出，今天我們重申了 2025 年全年的財務指導，結合了研發和銷售、一般及行政費用，並提高了 2025 年的收入框架。上個季度，我們概述了 Novavax 實現重大價值創造和潛在無差距盈利的途徑，我們專注於執行該計劃。我稍後會在評論中進一步闡述這些觀點。

Please turn to slide 11. I'll begin with key highlights from our first quarter of 2025 financial results. Novavax's reported total revenue of USD667 million as compared to USD94 million in the first quarter of 2024. The USD622 million of product sales in the current quarter includes USD603 million recognized in connection with the termination of the Canada and New Zealand APA agreements. Both of these agreements are now fully closed, and the revenue recognized relates to cash received in prior years. In addition, we recorded USD45 million from licensing, royalties, and other revenue.

請翻到第 11 張投影片。我先介紹我們 2025 年第一季財務表現的重點。Novavax 報告的總收入為 6.67 億美元，而 2024 年第一季為 9,400 萬美元。本季 6.22 億美元的產品銷售額包括因終止加拿大和紐西蘭 APA 協議而確認的 6.03 億美元。這兩項協議目前都已完全結束，確認的收入與前幾年收到的現金有關。此外，我們還從許可、特許權使用費和其他收入中獲得了 4,500 萬美元。

During the first quarter of 2025, we continued to transform Novavax into a more lean and agile organization. We strengthened our balance sheet, reducing our current liabilities by over 60% compared to year-end 2024, and improved our cost structure by reducing combined R&D and SG&A costs by 24% compared to the same period last year. For 2025, we are reiterating our full year financial guidance for combined R&D and SDNA expenses of between USD475 million and USD525 million. At the midpoint, this reflects a 30% reduction when compared to 2024. On the note, we continue to work with FDA on the parameters of the requested post marketing commitment study related to our BLA. For now, we believe it should be assumed that our multi-year guidance includes the potential impact Novovax of this post-marketing commitment.

2025 年第一季度，我們繼續將 Novavax 轉變為一個更精簡和敏捷的組織。我們加強了資產負債表，與 2024 年底相比，我們的流動負債減少了 60% 以上，並且透過與去年同期相比減少 24% 的研發和銷售、一般及行政費用總額來改善我們的成本結構。對於 2025 年，我們重申全年財務指導，即研發和 SDNA 綜合支出在 4.75 億美元至 5.25 億美元之間。從中點來看，與 2024 年相比減少了 30%。值得注意的是，我們將繼續與 FDA 合作，制定與我們的 BLA 相關的上市後承諾研究的參數。目前，我們認為應該假設我們的多年指導包括 Novovax 此次上市後承諾的潛在影響。

If needed, our guidance and operating plan may be updated based upon the outcome of that discussion. In parallel, we are working closely with our partner Sanofi to determine the potential approach to funding. We ended the first quarter with just under USD800 million in cash and receivables during 2025. We anticipate earning an additional USD225 million in milestones from Sanofi, assuming the approval in the US and Europe, and a USD20 million upfront payment in the second quarter from Takata related to our amended license agreement. These anticipated cash flows from our licensed partners highlight Novavax's potential to create significant shareholder value by monetizing our cutting-edge technology.

如果需要，我們的指導和營運計劃可能會根據討論的結果進行更新。同時，我們正在與合作夥伴賽諾菲密切合作，以確定潛在的融資方式。截至 2025 年第一季度，我們的現金和應收帳款總額略低於 8 億美元。假設在美國和歐洲獲得批准，我們預計將從賽諾菲獲得額外的 2.25 億美元里程碑收入，並且在第二季度從高田獲得與我們修改後的許可協議相關的 2000 萬美元預付款。來自我們授權合作夥伴的這些預期現金流凸顯了 Novavax 透過將我們的尖端技術貨幣化來創造巨大股東價值的潛力。

Based on our current operating plan, including milestone payments, royalties, and the multi-year expense targets, we have highlighted a path towards our goal of non-gap profitability as early as 2027 and maintaining at least 1.5 to 2 years of cash on hand at all times.

根據我們目前的營運計劃，包括里程碑付款、特許權使用費和多年支出目標，我們已經確定了一條實現無差距盈利目標的途徑，即最早在 2027 年實現無差距盈利，並始終保持至少 1.5 至 2 年的現金儲備。

Please turn to slide 12 for a detailed view of our first quarter revenue results and disclosures. You will see that beginning this quarter we are highlighting two categories under product sales. Novaxavid reflects product sales where Novavax is the commercial market lead and records revenue related to the sales and distribution of our COVID-19 vaccine. This is where we historically recorded our APA and commercial market sales. New beginning in 2025 is a category called supply sales that includes sales of finished products, Matri-M and Image event, and other supplies to our license partners. Under supply sales, we act as a contract manufacturer to our licensed partners to support their development and sales of vaccines to customers around the world, leveraging our proven technology. In prior years we recorded the supply sales under licensing, royalties, and other as they were less material at that time.

請翻到第 12 張投影片來詳細了解我們第一季的收入結果和揭露情況。您將看到，從本季開始，我們將重點放在產品銷售下的兩個類別。Novaxavid 反映產品銷售額，其中 Novavax 是商業市場的領先者，並記錄與我們的 COVID-19 疫苗的銷售和分銷相關的收入。這是我們歷史上記錄 APA 和商業市場銷售額的地方。2025 年的新起點是一個名為供應銷售的類別，其中包括成品、Matri-M 和 Image 活動的銷售，以及向我們的許可合作夥伴銷售的其他供應品。在供應銷售方面，我們作為授權合作夥伴的合約製造商，利用我們成熟的技術支援他們開發疫苗並向世界各地的客戶銷售疫苗。在前幾年，我們記錄了許可、特許權使用費和其他費用下的供應銷售額，因為當時這些費用不太重要。

For the first quarter of 2025, we recorded total revenue of USD667 million compared to USD94 million in the same period in 2024. Product sales for the first quarter of 2025 were USD622 million driven by USD603 million of revenue related to the closeout of the Canada and New Zealand APAs. In each case, this resolution allows Novavax to retain cash previously received under these agreements and resolves any outstanding obligation via payments of USD28 million and USD0.04 million to Canada and New Zealand respectively in the first quarter. The remaining USD5 million from Navaxavid product sales in the first quarter relates to sales in the US and Germany.

2025 年第一季度，我們的總營收為 6.67 億美元，而 2024 年同期為 9,400 萬美元。2025 年第一季的產品銷售額為 6.22 億美元，其中與加拿大和紐西蘭 APA 結算相關的收入為 6.03 億美元。在每種情況下，該解決方案都允許 Novavax 保留根據這些協議先前收到的現金，並透過在第一季分別向加拿大和紐西蘭支付 2,800 萬美元和 4 萬美元來解決任何未償債務。第一季 Navaxavid 產品銷售額的剩餘 500 萬美元來自美國和德國的銷售。

Our supply sales of USD14 million in the first quarter of 2025 were primarily related to Matrix and adjuvant sales to our license partners.

2025 年第一季度，我們的供應銷售額為 1,400 萬美元，主要與向我們的許可合作夥伴銷售基質和佐劑有關。

We recorded USD45 million of licensing, royalties, and other revenue in the first quarter consisting of USD40 million related to our Sanofi agreement and USD5 million from royalties from our other licensed partners. The Sanofi revenue consists of USD29 million from the amortization of our upfront payment and database lock milestones plus USD11 million from R&D reimbursements in the period as we support Sanofi in their efforts.

我們在第一季記錄了 4500 萬美元的許可、特許權使用費和其他收入，其中 4000 萬美元與我們的賽諾菲協議有關，500 萬美元來自我們其他許可合作夥伴的特許權使用費。賽諾菲的收入包括來自我們預付款和資料庫鎖定里程碑的攤銷的 2900 萬美元，加上我們支持賽諾菲努力期間研發報銷的 1100 萬美元。

Please turn to slide 13 for a detailed view of our first quarter financial results where I'll focus on our operating expense results and trends. First quarter of 2025 combined R&D and SD&A expenses were USD137 million and reflect the 24% reduction from the same period in 2024. Importantly, our SD&A expense of USD48 million is 45% lower than the same period last year and is driven by the decrease and close out of our global sales and marketing capabilities plus strong execution on our broader cost reduction plan.

請翻到第 13 張投影片來詳細了解我們的第一季財務業績，我將重點介紹我們的營運費用結果和趨勢。2025 年第一季研發和 SD&A 費用合計為 1.37 億美元，較 2024 年同期減少 24%。重要的是，我們的 SD&A 費用為 4800 萬美元，比去年同期下降了 45％，這是由於我們全球銷售和行銷能力的下降和關閉，以及我們更廣泛的成本削減計劃的強力執行。

Research and development expenses of USD89 million in the first quarter of 2025 were primarily driven by our investments in the phase 3 flu study and support of Sanofi for the upcoming COVID-19 vaccine season. A smaller portion of this is presently directed towards our early-stage preclinical programs. We intend to focus our attention on partnering our kick and flu vaccine candidates, and this study reflects the material completion of our intended investments in this program. And finally, we reported net income of USD519 million or USD2.93 per diluted share for the first quarter of 2025.

2025 年第一季的研發費用為 8,900 萬美元，主要來自我們對 3 期流感研究的投資以及對賽諾菲即將到來的 COVID-19 疫苗季節的支持。其中一小部分目前用於我們的早期臨床前計畫。我們打算將注意力集中在與我們的疫苗和流感候選疫苗的合作上，這項研究反映了我們對該計劃的預期投資的實質完成。最後，我們報告 2025 年第一季的淨收入為 5.19 億美元，即每股攤薄收益 2.93 美元。

Please turn to slide 14. Our first quarter 2025 results highlight the significant progress we have made this year to improve our balance sheet by reducing current liabilities by USD732 million. Since 2022, we have reduced Nova A's current liabilities by USD2.1 billion and over 80%. During the first quarter, our change in cash of approximately USD250 million included the elimination of many short-term liabilities, and we expect our go forward its expenditures to be lower, specifically. We anticipate our expenditure rate, which reflects our net spend prior to new cash flows from royalties and milestones, to be in the USD140 to USD160 million range per quarter and declining over time. We believe this progress places Novavax in a stronger financial position as we execute on our growth strategy.

請翻到第 14 張投影片。我們的 2025 年第一季業績凸顯了我們今年透過減少 7.32 億美元的流動負債來改善資產負債表所取得的重大進展。自2022年以來，我們已將Nova A的流動負債減少了21億美元，降幅超過80%。在第一季度，我們的現金變化約為 2.5 億美元，其中包括消除許多短期負債，我們預計未來的支出將會更低。我們預計支出率（反映特許權使用費和里程碑產生的新現金流之前的淨支出）將在每季 1.4 億美元至 1.6 億美元之間，並且會隨著時間的推移而下降。我們相信，這項進展將使 Novavax 在執行成長策略的過程中擁有更強大的財務狀況。

Please turn to slide 15.

請翻到第 15 張投影片。

We are committed to streamlining our operating expenses to enable value creation for 2025. We are reiterating our full year combined R&D and SD&A expense guidance of between USD475 and USD525 million. We intend to invest approximately 70% of this combined spend into R&D to drive shareholder value as we allocate our resources towards what we believe are the highest return activities. During 2025 we expect our operating expenses to be highest in the first half of the year as we conclude our kick & flu study and the decline through the second half of the year.

我們致力於精簡營運費用，以實現 2025 年的價值創造。我們重申全年研發和 SD&A 費用預計在 4.75 億美元至 5.25 億美元之間。我們打算將這筆總支出的約 70% 投入研發中，以推動股東價值，因為我們將資源分配給了我們認為回報最高的活動。我們預計，2025 年上半年我們的營運費用將達到最高，因為我們完成了疫情衝擊和流感的研究，而下半年的營運費用將下降。

Looking forward, we expect to achieve combined R&D and SG&A expenses of approximately USD250 million in 2027 and believe we are well on our way to achieving this goal. As mentioned earlier, we continue to work with FDA on the parameters of the requested post marketing commitment study. For now, it should be assumed that our multi-year guidance includes the potential impact to Novavax of this post-marketing commitment. Reducing our cost structure is an important piece of our drive towards non-gap profitability as early as 2027. We define non-gap profitability as GAAP operating profitless non-cash items such as stock base comp and depreciation. Keys to the timing on our path to profitability are the successful development, regulatory approval, and commercialization of products by our partner Sanofi under our agreement.

展望未來，我們預計 2027 年研發和銷售、一般及行政費用合計將達到約 2.5 億美元，並相信我們正在順利實現這一目標。如前所述，我們將繼續與 FDA 合作，制定所要求的上市後承諾研究的參數。目前，應該假設我們的多年指導包括這項上市後承諾對 Novavax 的潛在影響。降低成本結構是我們力求在 2027 年實現無差距獲利的重要措施。我們將非差距獲利能力定義為 GAAP 經營無利潤的非現金項目，例如股票基礎補償和折舊。我們獲利的關鍵時機是我們的合作夥伴賽諾菲根據我們的協議成功開發、獲得監管部門批准和產品商業化。

Please turn to slide 16. Now turning to our 2025 revenue framework, today we are raising our prior revenue framework and now expect to achieve adjusted total revenue of between USD975 million and USD1.025 billion. Our 2025 revenue framework excludes Sanofi's supply sales, royalties, and influenza COVID-19 combination, and Matrix-M related milestones. This means there may be revenue in 2025 that is additive to our expectations for adjusted total revenue for the year.

請翻到第 16 張投影片。現在談到我們的 2025 年收入框架，今天我們提高了先前的收入框架，現在預計調整後的總收入將達到 9.75 億美元至 10.25 億美元之間。我們的 2025 年收入框架不包括賽諾菲的供應銷售、特許權使用費和流感 COVID-19 組合以及 Matrix-M 相關里程碑。這意味著 2025 年的收入可能會增加我們對當年調整後總收入的預期。

At midpoint, the USD675 million increase to our 2025 adjusted total revenue is driven by first the addition of USD610 million of Navexited product sales that includes our first quarter results and a small number of sales in the second quarter of 2025. Second, a USD15 million increase to adjusted supply sales related to increased demand for Matrix M, from serum for the R21 malaria vaccine, and from Takeda for COVID-19.

從中點來看，我們 2025 年調整後總營收增加 6.75 億美元，首先是由於 Navexited 產品銷售額增加了 6.1 億美元，其中包括我們第一季的業績和 2025 年第二季的少量銷售額。其次，調整後的供應銷售額增加了 1500 萬美元，原因是對 Matrix M（來自 R21 瘧疾疫苗血清）和武田 COVID-19 的需求增加。

And third, a USD50 million increase to adjusted licensing, royalties, and others that has two components a USD30 million increase to other partner revenue driven by a USD20 million upfront payment from Takata in the 2nd quarter and anticipated milestones and royalties from our licensed partners and also. A USD20 million increase to amortization related to the Sanofi upfront payment and pediatric milestone. This reflects a timing update that shifts amount into 2025 that were previously anticipated to be recorded in 2026. We look forward to sharing additional updates as we improve Novavax's financial performance, cost structure, and strength to deliver shareholder value. With that, I'd like to turn the call back over to John for some closing remarks.

第三，調整後的許可、特許權使用費和其他費用增加了 5000 萬美元，其中包括兩個部分：其他合作夥伴收入增加了 3000 萬美元，這得益於高田在第二季度支付的 2000 萬美元預付款以及我們許可合作夥伴預期的里程碑和特許權使用費。與賽諾菲預付款和兒科里程碑相關的攤銷增加 2000 萬美元。這反映了時間更新，即將先前預計在 2026 年記錄的金額轉移到 2025 年。我們期待在改善 Novavax 的財務表現、成本結構和實力以實現股東價值的過程中分享更多更新資訊。說完這些，我想把電話轉回給約翰，讓他做一些結束語。

Thank you, Jim. In summary, we intend to drive value creation through our corporate growth strategy, and in 2025 we'll continue to focus on our three strategic priorities. Priority one, executing on our Sanofi partnership and in doing so successfully demonstrating we're our partner of choice. Priority 2 leveraging our technology platform and pipeline to forge additional partnerships. And priority 3 advancing our tech platform and early-stage pipeline to help foster additional partnering and growth opportunities.

謝謝你，吉姆。總而言之，我們打算透過企業成長策略來推動價值創造，2025 年我們將繼續專注於三大策略重點。首要任務是執行與賽諾菲的合作關係，並成功證明我們是我們選擇的合作夥伴。第二大優先事項是利用我們的技術平台和管道建立更多合作夥伴關係。第三大優先事項是推動我們的技術平台和早期階段的通路建設，以幫助培育更多的合作和成長機會。

Thank you all for joining us today and thank you to all of our employees for their continued efforts in advancing our business. I'm proud of our accomplishments to date and excited about the opportunity to drive future value from our strategy in 2025 and beyond. I'd now like to turn to turn the call over to our operator for Q&A operator.

感謝大家今天的到來，也感謝我們所有員工為推動我們的業務所做的持續努力。我為我們迄今為止所取得的成就感到自豪，並對 2025 年及以後透過我們的策略推動未來價值的機會感到興奮。現在我想將電話轉給我們的接線生進行問答。

Thank you. We will now begin the question and answer session. To ask a question, you may press bar, followed by the number 1 on your Touchstone phone. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star, followed by the number 2. At this time, we will pause momentarily to assemble our roster. Your first question comes from the line of Rogers song of Jeffrey's. Your line is not open.

謝謝。我們現在開始問答環節。要提問，您可以按下 Touchstone 手機上的 bar，然後按數字 1。如果您使用的是揚聲器電話，請在按任何按鍵之前拿起聽筒。若要撤回您的問題，請按星號，然後按數字 2。此時，我們將暫時暫停以整理我們的名冊。您的第一個問題來自傑弗裡·羅傑斯歌曲中的一句歌詞。您的線路未開通。

Great, good morning. Thanks for the update and taking our question. A couple of questions from us. The first one is regarding the post marketing commitment if you requested. Can you just comment on the nature of the study, in terms of the efficacy versus safety requirement? And then also we just know in two weeks, we pack going to host the meeting to select the seat string for the 2025, 2026 season. How do you think this post marketing commitment is going to impact the 2025 and 206 season? And I have a follow up question regarding the kick. Thank you.

太好了，早安。感謝您的更新並回答我們的問題。我們有幾個問題。如果您要求的話，第一個是關於上市後承諾。您能否從功效與安全性要求的角度來評論一下這項研究的性質？而且我們也知道，兩週後，我們將召開會議，選擇 2025、2026 年賽季的座位。您認為此次行銷承諾將如何影響 2025 年和 206 年賽季？我還有一個關於踢球的後續問題。謝謝。

Hi Roger. Good to hear from you and thanks for the questions. We haven't commented publicly on the nature of the post marketing commitment at this time, but we're, as we've said a few times, and we'll continue to say today right now we continue to work with the FDA diligently and urgently to try to bring this forward as soon as possible to a positive conclusion, and we do see a pathway forward to approval based on the formal comments and questions we've received from FDA, so. We'll keep you posted as that develops and right now we're not seeing a direct impact on any discussions VPAC may be having on the season related directly or indirectly to any requests we may have had in our BLA.

你好，羅傑。很高興收到您的來信，感謝您的提問。目前，我們尚未公開評論上市後承諾的性質，但正如我們多次說過的，並且我們今天還會繼續說，我們現在將繼續與 FDA 勤勉而緊急地合作，試圖盡快使此事取得積極的結論，並且根據我們從 FDA 收到的正式評論和問題，我們確實看到了獲得批准的途徑。我們會隨時向您通報事態發展，目前，我們尚未發現 VPAC 就本賽季進行的任何討論受到直接影響，這些討論與我們在 BLA 中提出的任何請求直接或間接相關。

Got it. That's fair. And then regarding the mid-year data readout for your program kick and the flu, what is the target profile you're looking for and then, to attract the partnership, for the further development and the commercialization. Thank you.

知道了。這很公平。然後，關於您的計劃爆發和流感的年中數據讀數，您正在尋找的目標概況是什麼，然後吸引合作夥伴，進行進一步開發和商業化。謝謝。

All right, I'll hand that question over to Roxandra Roger, and if we heard you right, you were asking about the nature of that data or what we're expecting or hoping to see in that cohort, Roxandra, of our phase 3 program.

好的，我將這個問題交給 Roxandra Roger，如果我們沒聽錯的話，您問的是這些數據的性質，或者我們期望或希望在我們第三階段計劃的隊列中看到什麼，Roxandra。

Thank you, John. So, as I have mentioned in my intervention, we have enrolled a first cohort of approximately 2000 individuals in this and flu study. We are looking for immunogenicity and safety data that could complement what we. We have from our previous studies that would help design a phase 3 trial. So, this is not an efficacy trial. Let me be very clear. It is to generate additional immunogenicity and safety data.

謝謝你，約翰。因此，正如我在幹預中提到的那樣，我們已經招募了第一批約 2000 名個體參與這項流感研究。我們正在尋找可以補充我們的免疫原性和安全性數據。我們從先前的研究中獲得了有助於設計第三階段試驗的資訊。所以，這不是一項功效試驗。讓我說得更清楚一點。這是為了產生額外的免疫原性和安全性數據。

Yeah, it's not a pivotal trial, Roger. You're right, it's a learning data set to help further inform what may be required for a full licensure with a partner, and as we've said before, it's our intention to partner both our late stage kick and flu assets out, and that would be our intent.

是的，這不是一個關鍵的審判，羅傑。你說得對，這是一個學習數據集，有助於進一步了解與合作夥伴獲得完整許可可能需要什麼，正如我們之前所說，我們打算將我們的後期踢和流感資產合作出去，這就是我們的目的。

Got it, yeah.

明白了，是的。

Thank you. Your next question comes from the line of Maya Montani from B B Riley Securities. Your line is now open.

謝謝。您的下一個問題來自 B B Riley Securities 的 Maya Montani。您的線路現已開通。

Yes, good morning team. Thanks for taking our questions and congrats on the progress, yeah, thanks, Sean. So I was wondering, in context of this, Utah Shield study that was published, I was just curious how much is this quality of life activities of daily living kind of factored in regulatory science, as FDA as well as global regulators think of adjuvanted protein-based vaccines versus MRNA, and I was also curious. This talk on contemporary placebo controlled study required like how does that inform your thinking of what a registration enabling phase 3 trial would look like for your wholly owned, kick and flu vaccine and I have a quick follow up.

是的，大家早安。感謝您回答我們的問題，並祝賀取得的進展，是的，謝謝，肖恩。因此，我想知道，在已發表的猶他盾研究的背景下，我只是好奇這種日常生活活動品質在多大程度上被納入監管科學，因為 FDA 以及全球監管機構認為佐劑蛋白疫苗與 MRNA 相比，我也很好奇。這次關於當代安慰劑對照研究的演講要求您思考如何為您的全資擁有的、針對流感疫苗的 3 期臨床試驗註冊，我有一個快速的跟進。

Mike, I'll hand that your first question over to Roxandra if we heard you correctly, if we understand your question right, you're asking about the impact that data from our shield study. That type of data may have on the opinions of regulators around the world. Did we hear you correctly?

麥克，如果我們聽得正確的話，如果我們理解你的問題正確的話，我會把你的第一個問題交給羅克珊德拉，你問的是我們的屏蔽研究數據的影響。這類數據可能會影響世界各地監管機構的意見。我們聽清楚了嗎？

That is correct. And how you're thinking of the bigger pivotal study for the kick and flow in.

沒錯。以及您如何看待踢球和流入的更大關鍵研究。

Context. Okay, so, why don't you take the first question, please.

情境.好的，那請你回答第一個問題。

Yeah, thank you, John. So let's be clear, the Utah study is an observational study. Yeah, so basically based on a questionnaire asking about the quality of life of individuals, this is not part of a typical regulatory submission. It is to inform probably much more the consumers rather than the regulators. We cannot speculate how the regulators are going to look at that particular data. They are actually looking at the safety and efficacy of each of the vaccines on their own merit, yeah, but after the introduction of any vaccine, actually, not only a COVID vaccine or a flu vaccine in the population, but there are also a lot of these real-world evidence studies that are looking at different characteristics. So that UA study is in that particular category.

是的，謝謝你，約翰。所以讓我們明確一點，猶他州的研究是一項觀察性研究。是的，所以基本上是基於詢問個人生活品質的問卷，這不是典型的監管提交的一部分。它可能更多是為了告知消費者而不是監管者。我們無法推測監管機構將如何看待這些特定數據。是的，他們實際上正在根據每種疫苗的優點來研究其安全性和有效性，但實際上，在引入任何疫苗後，不僅是針對人群的 COVID 疫苗或流感疫苗，而且還有大量針對不同特徵的真實世界證據研究。因此 UA 研究屬於該特定類別。

Thank you, Roxandra. And then Mike, your next question had to do with, were you asking about phase 3 for our potential late stage asset like our combination vaccine?

謝謝你，Roxandra。然後麥克，你的下一個問題是，你是在問我們的潛在後期資產（例如聯合疫苗）的第三階段嗎？

That's right.

這是正確的。

And whether or not it would be placebo controlled.

以及是否採用安慰劑對照。

Yeah, just you're thinking around what the vaccine efficacy study would look like after, you've generated this immunity data.

是的，你只是在思考在產生這些免疫數據之後，疫苗功效研究會是什麼樣子。

We, well, we're going to be again, as we said, Novavax does not intend to take on ourselves further clinical investment in those late-stage programs. We intend to do that with a partner. So we're currently seeking a partner, and if and when we get a partner, we'll be designing the study with them, and at that time then we will be disclosing how that study is designed. When it comes to placebo controlled, our existing efficacy data for Nuvaxivid was based upon an initial placebo controlled trial with approximately 30,000 patients. So we've done that before with our products, but any new trial would be designed with a partner. That's our intent.

好吧，正如我們所說，我們將再次強調，Novavax 不打算對這些後期項目進行進一步的臨床投資。我們打算與合作夥伴一起實現這一目標。因此，我們目前正在尋找合作夥伴，如果我們找到合作夥伴，我們將與他們一起設計這項研究，屆時我們將揭露研究的設計方式。當涉及安慰劑對照時，我們現有的 Nuvaxivid 療效數據是基於對約 30,000 名患者進行的初步安慰劑對照試驗。我們之前已經對我們的產品做過這樣的試驗，但任何新的試驗都會與合作夥伴一起設計。這就是我們的意圖。

Yeah, I, and I asked that also since your partner is conducting a phase 12 experiment with an active comparative, Santa Fe has with some data expected in the second half, and maybe my follow up question was on the, your earlier stage pipeline. If you could comment, Sandra back to you on the order of IND filings or human clinical trial starts for these early stage programs you've identified and, Jim can comment on whether you know some of these early discussions you're having for the partner, not the partner, but, programs under the MTA that are being reviewed if any of that is included in your financial guidance framework, thanks for taking our questions.

是的，我問過這個問題，因為您的合作夥伴正在進行第 12 階段的實驗，並有一個活躍的比較，聖達菲預計在下半年會有一些數據，也許我的後續問題是關於您早期階段的管道。如果您可以發表評論，桑德拉，請回复您關於您所確定的這些早期項目的 IND 申請或人體臨床試驗開始的順序，吉姆可以評論一下，您是否知道您正在為合作夥伴進行的一些早期討論，不是合作夥伴，而是正在審查的 MTA 下的項目，如果其中任何一項包含在您的財務指導框架中，感謝您回答我們的問題。

Rox, why don't you take M's question on the early-stage programs.

Rox，為什麼不回答 M 關於早期專案​​的問題呢？

So, the definition of an early-stage program is that it is early. Yeah, we are actually very diligently working on generating very rigorous per clinical data on each of the programs that I have mentioned. And we will be happy to share with you and with the external stakeholders data in the second half of the year. So I cannot comment on each and every one of the programs of exactly where we are. It's pretty clinical, so by nature it is evolving practically every day. Sometimes we have results twice a day, so. Stay tuned for the second half of the year.

因此，早期專案的定義就是早期。是的，我們實際上正在非常努力地為上述每個項目產生非常嚴格的臨床數據。我們將很高興與您和外部利害關係人分享下半年的數據。因此我無法評論每一個項目的具體進展。它非常具有臨床意義，因此本質上它幾乎每天都在發展。有時我們一天會得到兩次結果，所以。敬請期待下半年的走勢。

And then I think Mike, you were trying to ask about timing for any IDs that might come out of our early stage program, but we haven't specified that at this time. But I think you use a normal assumptions on that when you're coming out of the clinic, and I think more that'll be more clear also in the second half of the year as we as we share some initial results on these programs. Go ahead, Jim, on question two.

然後我想 Mike，你想詢問我們早期階段計劃中可能出現的任何 ID 的時間，但我們目前還沒有具體說明。但我認為，當你走出診所時，你會對此使用正常的假設，而且我認為，當我們在今年下半年分享這些項目的一些初步結果時，這一點也會更加清晰。吉姆，繼續回答第二個問題。

And Mike, I think the final piece is you are asking whether or not any yet to be entered into agreements are factored or included in our revenue framework, and the answer is no. Our revenue framework is based upon our existing agreements, so stay tuned. We're clearly working on that front.

麥克，我認為最後一個問題是，你問的是尚未達成的協議是否被考慮或包含在我們的收入框架中，答案是否定的。我們的收入框架是基於我們現有的協議，敬請關注。我們顯然正在為此努力。

Thanks for taking the questions and look forward to those updates.

感謝您回答這些問題，並期待您的更新。

Thank you. Your next question comes from the line of Alex Brunehan of Bank of America. Your line is not open.

謝謝。您的下一個問題來自美國銀行的 Alex Brunehan。您的線路未開通。

Hey guys, thanks for taking our questions. Just 22 for me, maybe just starting on the APA revenues that got recognized this quarter. I guess how much of this is maybe cash today versus cash in the future, or is it basically all of it just revenue recognition of prior cash that's been received and then that's going to follow up?

嘿夥計們，感謝你們回答我們的問題。對我來說只有 22 個，也許只是從本季確認的 APA 收入開始。我猜這其中有多少是今天的現金，有多少是未來的現金，或者基本上所有這些都只是對之前收到的現金的收入確認，然後再進行跟進？

Jim, you want to take that one? Yes.

吉姆，你想拿那個嗎？是的。

Certainly, and certainly a good question. The EPA revenue recognition, the USD603 million from Canada and New Zealand, is non-cash. We had received that cash under those agreements in prior years. Of course it was on our balance sheet. And then through the termination and close out of those agreements, what that meant is that we get to keep that cash under the close out of those agreements.

當然，這確實是一個好問題。EPA 收入確認為來自加拿大和紐西蘭的 6.03 億美元，為非現金收入。我們在前幾年已經根據這些協議收到了現金。當然它在我們的資產負債表上。然後透過終止和結束這些協議，這意味著我們可以在這些協議結束後保留這些現金。

Okay, that makes sense. And then maybe just one question, around the kick readout, the middle of this year. Any bars for safety with the kick that you see as being, maybe key for partnership interest in the program, and is this maybe, more important to view this versus each standalone component on its own or versus, the other kick vaccines that that are in development. Thank you.

好的，這很有道理。然後也許只有一個問題，圍繞今年年中的踢球讀數。您認為，對於 Kick 疫苗的安全性而言，任何限制都可能是合作夥伴對該計劃產生興趣的關鍵，與單獨看待每個獨立組件或與正在開發的其​​他 Kick 疫苗相比，這是否更為重要？謝謝。

Go ahead, Roxandra.

繼續吧，Roxandra。

So, as I have mentioned, we have presented the data coming from a multitude of clinical trials that we have undertook with our vaccine platform and with the Matrix-M adjuvant at the World Vaccine conference, and by and large, the safety, the tolerability, the reactogenicity profile of our vaccines are favorable, yeah. So, in this particular 2000 individual cohort, aside from the immunogenicity data, we will also supplement our safety data. So, for the moment I think that this is not something that is different from what we have seen in the past, but of course data will speak and again we will have in the second half of this year additional data to share with you.

因此，正如我所提到的，我們在世界疫苗會議上展示了使用我們的疫苗平台和 Matrix-M 佐劑進行的大量臨床試驗的數據，總的來說，我們的疫苗的安全性、耐受性和反應原性特徵是良好的。因此，在這個特定的 2000 個個體隊列中，除了免疫原性數據之外，我們還將補充安全性數據。因此，目前我認為這與我們過去所看到的情況沒有什麼不同，但當然數據會說明一切，而且我們將在今年下半年再次提供更多數據與大家分享。

Oh, thank you.

噢，謝謝。

Thank you. Your next question comes from the line of Tom Schrader of PTIG. Your line is now open.

謝謝。您的下一個問題來自 PTIG 的 Tom Schrader。您的線路現已開通。

Good morning. Thanks for the detailed call. A very related question for the last one is the is the target profile of the combined vaccine is designed to make the reactogenicity about the same as stand-alone flu or is that inherently unrealistic because the COVID antigen is just react, reactogenic. Then I have a follow up.

早安.感謝您的詳細來電。與最後一個問題非常相關的一個問題是，聯合疫苗的目標概況是否旨在使反應原性與獨立流感疫苗大致相同，或者這本質上是不現實的，因為 COVID 抗原只是反應，是反應原性的。然後我會跟進。

I wouldn't say we proactively designed a study based on reactogenicity. We designed it to demonstrate. An immune response to both of the pathogens that are being targeted with that vaccine, as you're well aware, and then we'll see how the reactorgenicity profile looks. We would expect it to be reasonable based on what we know about our tech. And again this we need to be crystal clear, make sure everyone, what I want everyone to understand is this is a 2000 patient cohort. This is not a pivotal trial. This is not a full phase 3 program. This is not designed for registration. This is not designed to definitively prove anything long term about our vaccine. What it is designed to do as a small cohort is to add additional data into our data set to help us think about how to then design with a partner, which is our intent. A study that would be targeted to registration.

我不會說我們主動設計了一項基於反應原性的研究。我們設計它是為了演示。如您所知，針對該疫苗所針對的兩種病原體的免疫反應，然後我們將看到反應原性概況。根據我們對技術的了解，我們希望它是合理的。再次強調，我們需要非常清楚地確保每個人，我希望每個人都明白，這是一個 2000 名患者組成的群體。這不是一場關鍵的審判。這不是一個完整的第三階段計劃。這不是為註冊而設計的。這並不是為了明確證明我們的疫苗的長期效果。它作為一個小群體的設計目的是將額外的數據添加到我們的數據集中，以幫助我們思考如何與合作夥伴一起設計，這是我們的意圖。一項以註冊為目標的研究。

So that's the goal, Roxandra, anything you'd add to that?

這就是目標，Roxandra，您還有什麼要補充的嗎？

No, you said it all, John. Perfect, thank you.

不，你已經說完了，約翰。非常好，謝謝。

Thank you.

謝謝。

And if I can ask a follow up about the filing for your updated vaccine that's in front of the FDA now, how much human data is in there from the updated vaccine? Is it none or is there a cohort for immunogenicity? What has the FDA seen in terms of data of this exact vaccine in people? Thanks.

如果我可以問一下關於你們現在提交給 FDA 的更新疫苗申請的後續問題，那麼更新疫苗中包含多少人體數據？免疫原性是否不存在或是否存在？FDA 對這種疫苗在人體的應用數據有何看法？謝謝。

Sorry, Tom, we just want to make sure we fully understand your question. Could you just clarify, just take a shot at clarifying that, and then Roxandra will try to answer you.

抱歉，湯姆，我們只是想確保我們完全理解你的問題。您能否澄清一下，嘗試澄清一下，然後 Roxandra 會嘗試回答您。

So, you have a filing in front of the FDA to update your vaccine, right? And the question is there any human data in that filing? To with the updated vaccine, so they would have some sense that some numbers of people have seen the vaccine and I probably to monitor immunogenicity or is there no human data for the actual updated vaccine?

那麼，您需要向 FDA 提交文件來更新您的疫苗，對嗎？問題是該文件中是否包含任何人類資料？對於更新後的疫苗，他們會不會感覺到有不少人已經接種過這種疫苗，而我可能需要監測其免疫原性，或者實際更新後的疫苗是否沒有人體數據？

I see. Go ahead, John T. Yeah.

我懂了。繼續，約翰 T。是的。

Hi. I think thanks for the clarification. I think it's important to understand what the BLA submission is and what's being reviewed. It's taking the existing product that's in market today under the emergency use authorization and getting a BLA approval for that vaccine, right? Remember, the basis for that BLA is on the clinical data to date. There's no new clinical data. It's from our phase 3 efficacy trial. And any other updated information that was relative to that to that filing. We then, after the approval of the BLA and some of the conversations we're having with FDA today would result and then a readiness for the 25, 26 marketplaces, which would include strain changes. But first step again, just to be clear, is the BLA for the existing product with no new clinical data relative to the JN1 strain.

你好。我想感謝您的澄清。我認為了解 BLA 提交是什麼以及正在審查什麼非常重要。它是根據緊急使用授權採用目前市場上的現有產品並獲得該疫苗的 BLA 批准，對嗎？請記住，該 BLA 的基礎是迄今為止的臨床數據。沒有新的臨床數據。這是我們第三階段功效試驗的結果。以及與該文件相關的任何其他更新資訊。然後，在 BLA 獲得批准並且我們今天與 FDA 進行的一些對話之後，我們將為 25、26 個市場做好準備，其中包括菌株變化。但需要再次明確的是，第一步是針對現有產品的 BLA，該產品沒有與 JN1 菌株相關的新臨床數據。

So, assuming, thank you, John, assuming we get the BLA approval and when we have it we'll have it until then we don't have it. But assuming we get that, then you'd make subsequent filings to your point, for an updated version of the vaccine to target whatever variant we'd be targeting. And then there's meetings upcoming to advise the government on that. VPAC was announced for later this month, etc. Where they'd make recommendations on that strain selection and then companies will be making submissions to update their vaccines. Hopefully we've understood your question clearly, and that was helpful.

所以，假設，謝謝你，約翰，假設我們獲得了 BLA 批准，當我們獲得批准時，我們就會擁有它，但在此之前我們還沒有它。但假設我們得到了這一點，那麼您將對您的觀點進行後續提交，以獲得更新版本的疫苗來針對我們針對的任何變體。隨後將召開會議，就此事向政府提供建議。VPAC 將於本月稍後宣布。屆時他們將針對菌株選擇提出建議，然後各公司將提交意見以更新其疫苗。希望我們已經清楚地理解了您的問題，並且這對您有所幫助。

Thank you very much again, if you have a question, please press star followed by the number one on your Touchstone phone. Your next question comes from the line of Eric Joseph. Your line is now open.

再次感謝您，如果您有任何問題，請在 Touchstone 手機上按星號，然後按數字 1。您的下一個問題來自 Eric Joseph。您的線路現已開通。

Hi, good morning. Thanks for taking the questions. As a condition of approval for the COVID-19 vaccine, is the discussion with FDA solely focused on the shape of the post marketing commitment? I just want to be confident that we can rule out additional clinical work being a condition for initial BLA approval. And then secondly, to what extent does the milestone, the approval milestone from Sanofi, A consider a post marketing commitment. I guess what I mean to ask there is whether that milestone may be impacted at all if an additional clinical trial is required as a condition of BOA approval. Thank you.

嗨，早安。感謝您回答這些問題。作為 COVID-19 疫苗的批准條件，與 FDA 的討論是否僅僅集中在上市後承諾的形式上？我只是想確信我們可以排除額外的臨床工作作為初步 BLA 批准的條件。其次，賽諾菲的里程碑、批准里程碑在多大程度上考慮了上市後的承諾。我想問的是，如果 BOA 批准要求進行額外的臨床試驗，那麼這個里程碑是否會受到影響。謝謝。

Jim. Why don't you take the milestone question first? Yeah.

吉姆。為什麼不先回答里程碑問題呢？是的。

Certainly, Eric, the milestone based upon BLA approval is not impacted by post marketing commitment. Still eligible to receive upon a BLA approved, even with a post marketing commitment, USD175 million milestone.

當然，艾瑞克，基於 BLA 批准的里程碑不會受到上市後承諾的影響。即使有上市後承諾，在 BLA 獲得批准後，仍然有資格獲得 1.75 億美元的里程碑。

Thank you, Jim. And then Eric, your other question, we just want to make sure we understand clearly. So are you asking, have we been asked to generate a new clinical study that would be required prior to a potential BLA approval and afterwards? Is that your question? We just want to make sure we're clear.

謝謝你，吉姆。然後艾瑞克，關於你的另一個問題，我們只是想確保我們理解清楚。那麼你是想問，我們是否被要求在潛在的 BLA 批准之前和之後開展一項新的臨床研究？這是你的問題嗎？我們只是想確保我們清楚。

It sounds like additional clinical trial work is possibly being requested as a condition of approval Is that being asked for before approval, or is it being asked as a as a condition?

聽起來好像需要進行額外的臨床試驗工作作為批准條件，這是在批准之前要求的，還是作為條件要求的？

All I can do is say what we've commented on publicly. Thank you for the question, and if folks have that on their mind, we hope to make it as clear as we can at this moment in time. Based on what we've received to date formally from FDA, they're asking for a post marketing commitment. And by definition, it's our understanding that a post-marketing commitment comes after approval and you've begun to market that product. So that's what we can share so far. That's what we've said so far. If anything changes, we'll let everybody know.

我所能做的就是公開發表我們所評論的內容。感謝您的提問，如果大家有這個問題，我們希望現在就盡可能地解釋清楚。根據我們迄今為止從 FDA 收到的正式訊息，他們要求提供上市後承諾。根據定義，我們的理解是，上市後承諾是在產品獲得批准並開始行銷該產品之後做出的。這就是我們目前能夠分享的內容。這就是我們目前所說的內容。如果有任何變化，我們會讓所有人知道。

Great, thanks for taking the question.

太好了，謝謝你回答這個問題。

Thank you. Your next question comes from the line of Chris Lubianco from Ed Securities. Your lines open.

謝謝。您的下一個問題來自 Ed Securities 的 Chris Lubianco。你的線路開通了。

So thank you for taking our question this morning. First, to the best of your knowledge, is the post-marketing clinical trial requirement specific to Novo that's BOI filing? Or do you expect FDA will ask all COVID-19 vaccines, including the mRNA vaccines, to generate efficacy data for booster doses in a broad population with pre-existing immunity. And then I had one follow up question. Thank you.

非常感謝您今天上午回答我們的問題。首先，據您所知，上市後臨床試驗要求是否專門針對 Novo 並向 BOI 提交？或者您是否預期 FDA 會要求所有 COVID-19 疫苗（包括 mRNA 疫苗）在具有預先免疫力的廣泛人群中產生加強劑量的有效性數據。然後我有一個後續問題。謝謝。

Thank you, Chris, for your question. Good to hear. Good to hear from you, and I'd like to ask the question back to you because if we'd love to find out, but in all seriousness, we really can't speculate on FDA's thoughts regarding other companies' filings. We know that we have our conversations ongoing with FDA, and that's all we can comment on at this time, Chris.

謝謝克里斯的提問。很高興聽到這個消息。很高興收到您的來信，我想再次向您提出這個問題，因為我們很想知道答案，但嚴肅地說，我們真的無法推測 FDA 對其他公司申請的想法。我們知道我們正在與 FDA 進行對話，目前我們只能對此發表評論，克里斯。

Great. And then just my follow up question is has your confidence in receiving FDA approval of the BLA in 2025 increased, decreased, or remained the same since the since the Q4 call in February 2025? And is it reasonable to expect an FDA decision near term, i.e., an H12025? Thank you.

偉大的。然後我的後續問題是，自 2025 年 2 月第四季電話會議以來，您對 2025 年獲得 FDA 批准 BLA 的信心是增加了、減少了還是保持不變？並預期 FDA 最近做出決定（例如 H12025）是否合理？謝謝。

Yeah, Chris, I'm not going to comment on a score on where our confidence is, but what I can do is share with you what we've already said publicly, which is that we're working right now with FDA, and we see a pathway, potential pathway forward for approval based on alignment on our post marketing commitment. And as we learn more, we'll let you know.

是的，克里斯，我不會對我們的信心水平發表評論，但我可以做的是與您分享我們已經公開說過的內容，那就是我們目前正在與 FDA 合作，並且我們看到了一條途徑，基於我們對上市後承諾的一致性，潛在的獲得批准的途徑。一旦我們了解更多信息，我們會告知您。

Operator.

操作員。

Folks, it seems like that was our last question, and we seem to be having technical difficulty. So, I would like to thank everyone for joining us today and note that we'll be ending the call at this time. Thank you again for your time and questions. Have a great day everyone.

各位，這似乎是我們最後一個問題，而且我們似乎遇到了技術困難。因此，我要感謝大家今天的參加，並請注意，我們將在此時結束通話。再次感謝您的時間和提問。祝大家有個愉快的一天。