Novavax Inc (NVAX) 2025 Q3 法說會逐字稿

Good morning, and welcome to Novavax's Third Quarter 2025 Financial Results and Operational Highlights Conference Call. (Operator Instructions) Please note this event is being recorded, and I would now like to turn the conference over to Luis Sanay, Vice President-Investor Relations. Please go ahead, sir.

早安，歡迎參加 Novavax 2025 年第三季財務業績與營運亮點電話會議。（操作員指示）請注意，本次活動正在錄製，現在我將把會議交給投資者關係副總裁路易斯·薩奈。請繼續，先生。

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

早安，感謝各位今天蒞臨現場，與我們共同探討我們2025年第三季的財務表現與營運亮點。我們已在網站 novavax.com 上發布了公佈研究結果的新聞稿，本次電話會議的音訊存檔將於今天稍後在網站上提供。

Please turn to Slide 2. Before we begin with prepared remarks, I need to remind you that this presentation includes forward-looking statements, including, 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, cost reimbursements; its expectations regarding manufacturing capacity, timing, production, and delivery for its COVID-19 vaccine.

請翻到第二張幻燈片。在正式發言之前，我需要提醒各位，本次演講包含前瞻性陳述，包括但不限於與 Novavax 公司戰略和運營計劃、戰略重點、合作夥伴關係以及對潛在特許權使用費、里程碑、成本補償的預期、以及對新冠疫苗的生產能力、時間安排、產量和交付的預期相關的陳述。

The development of Novavax's clinical and preclinical product candidates; the timing and results of our clinical trials, the timing of regulatory filings and actions, its APA agreements and related negotiations; full year 2025 financial guidance and revenue framework; full year 2026 revenue framework preview; and Novavax's future financial or business performance, including long-term growth, savings, and profitability targets.

Novavax 的臨床和臨床前候選產品的開發；臨床試驗的時間和結果、監管申報和行動的時間、APA 協議和相關談判；2025 年全年財務指導和收入框架；2026 年全年收入框架預覽；以及 Novavax 未來的財務或業務表現，包括長期增長、節約和盈利目標。

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 10-K and subsequent Form 10-Qs filed with the Securities and Exchange Commission, available at sec.gov and on our website at novavax.com.

本簡報中包含的每一項前瞻性陳述都存在風險和不確定性，可能導致實際結果與此類陳述中預測的結果有重大差異。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“關於前瞻性聲明的警示性說明”標題下的內容，以及我們最近向美國證券交易委員會提交的 10-K 表格和後續 10-Q 表格中“風險因素”標題下的內容，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.

本簡報中的前瞻性聲明僅代表截至本簡報發布之日的信息，我們不承擔更新或修改任何此類陳述的義務。

Please turn to Slide 3. This presentation also includes references to non-GAAP financial measures, which are total adjusted revenue, adjusted licensing, royalties, and other revenue, combined R&D and SG&A expenses, less partner reimbursements, and non-GAAP profitability.

請翻到幻燈片3。本次演示還包括對非公認會計準則財務指標的參考，這些指標包括調整後的總收入、調整後的許可費、特許權使用費和其他收入、研發和銷售、一般及行政費用合併（減去合作夥伴補償）以及非公認會計準則盈利能力。

Please turn to Slide 4. Joining me today is John Jacobs, our President and CEO, who will highlight our growth strategy and provide an update on our progress during the quarter; Dr. Ruxandra Draghia, Head of R&D, will discuss our R&D updates; and Jim Kelly, Chief Financial Officer and Treasurer, will review our financial results and 2025 financial guidance and revenue framework.

請翻到第4頁投影片。今天與我一同出席的有：總裁兼首席執行官約翰·雅各布斯，他將重點介紹我們的增長戰略，並匯報本季度的進展情況；研發主管魯克桑德拉·德拉吉亞博士將討論我們的研發進展；首席財務官兼財務主管吉姆·凱利將回顧我們的財務業績以及2025年的財務指導和收入框架。

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

現在我想把電話交給約翰。

Thank you, Luis. I'm excited to be here today with members of our executive team to share our third quarter results. During Q3, we progressed our corporate strategy of driving growth and value by continuing to strengthen existing partnerships and build new collaborations while advancing R&D innovation and our early-stage pipeline.

謝謝你，路易斯。今天我很高興能和我們的高階主管團隊成員一起在這裡分享我們第三季的業績。第三季度，我們透過持續加強現有合作夥伴關係和建立新的合作關係，同時推動研發創新和早期產品線，推動了推動成長和價值的企業策略。

Please turn to Slide 5. We've been on a steady path to transform Novavax since I joined the organization in 2023. With our new corporate strategy as our guide, we have an exciting opportunity to drive value for our shareholders and the communities we serve for decades to come. Let me take you through how we intend to get there and the progress we've already made.

請翻到第5張投影片。自從我 2023 年加入 Novavax 以來，我們一直在穩步推進 Novavax 的轉型。以我們新的企業策略為指導，我們擁有一個令人興奮的機會，在未來幾十年為我們的股東和我們所服務的社區創造價值。讓我帶您了解我們打算如何實現目標以及我們已經取得的進展。

When I joined the organization in 2023, we were a fully-integrated commercial organization, primarily focused on sales of our COVID-19 vaccine. Our imperative at that time was to stabilize the company financially.

2023年我加入該組織時，我們是一個完全一體化的商業組織，主要專注於銷售我們的新冠疫苗。當時我們的當務之急是穩定公司的財務狀況。

And to that end, we removed more than $1 billion of current liabilities by year-end 2024 compared to 2022. During that same period, we also reduced almost $1 billion in operating expenses. In addition, in 2024, we announced a significant and multifaceted partnership with Sanofi, which has now allowed us to accelerate the next phase of the company's planned evolution.

為此，到 2024 年底，我們比 2022 年減少了超過 10 億美元的流動負債。同期，我們也削減了近10億美元的營運費用。此外，2024 年，我們宣布與賽諾菲建立重要的、多方面的合作夥伴關係，這使我們能夠加速公司計畫發展的下一階段。

This year, we relaunched Novavax as a company, focused on partnerships and R&D innovation. Our new strategy is centered on amplifying the impact of our technology platform through collaborations with other biopharmaceutical companies and a new diversified pipeline. And this represents a strategic and thoughtful departure away from a single focus on the resource-intense commercialization of one product, our COVID vaccine.

今年，我們重新推出了 Novavax 公司，專注於合作夥伴關係和研發創新。我們的新策略以透過與其他生物製藥公司合作以及開發新的多元化產品線來擴大我們技術平台的影響力為中心。這代表著一種策略性和深思熟慮的轉變，即不再僅僅專注於資源密集型產品（即我們的新冠疫苗）的商業化。

To date, we have made significant progress on this strategy. For example, over the past eight quarters, we've achieved approximately $1.1 billion in nondilutive cash flow to the company, including $800 million from our partnerships in the form of upfront payments and milestones earned to date.

迄今為止，我們在該戰略方面取得了顯著進展。例如，在過去的八個季度中，我們為該公司實現了約 11 億美元的非稀釋性現金流，其中包括來自合作夥伴關係的 8 億美元，以預付款和迄今為止獲得的里程碑付款的形式。

We also just recently expanded our Sanofi partnership to include use of our Matrix-M adjuvant in their pandemic flu vaccine candidate, for which Sanofi received a U.S. BARDA grant. We renegotiated our agreement with Takeda, which enhanced our revenue opportunity from their activities with Nuvaxovid in Japan, one of the world's largest health care markets.

我們最近也擴大了與賽諾菲的合作關係，將我們的 Matrix-M 佐劑應用於他們的流感大流行疫苗候選產品中，為此賽諾菲獲得了美國生物醫學高級研究與發展局 (BARDA) 的撥款。我們與武田製藥重新談判了協議，這提高了我們從武田製藥在日本（全球最大的醫療保健市場之一）的 Nuvaxovid 業務中獲得的收入機會。

On the R&D front, via a lean strategic investment approach, in Q1 of this year, we launched a new early-stage portfolio, including programs targeting C. diff, shingles, RSV combination, and pandemic flu, and initiated an exploration of our Matrix-M technology platform to assess its applicability in oncology.

在研發方面，透過精實的策略性投資方法，今年第一季度，我們推出了一個新的早期項目組合，其中包括針對艱難梭菌、帶狀皰疹、呼吸道合胞病毒組合和流行性流感的項目，並開始探索我們的 Matrix-M 技術平台，以評估其在腫瘤學中的適用性。

And finally, on our financial profile, we continue to improve the financial strength of the company while maintaining our capabilities. For example, most recently, we brought in $60 million in near-term cash and anticipated long-term savings of approximately $230 million by consolidating our Maryland campus footprint.

最後，就我們的財務狀況而言，我們在維持自身能力的同時，也不斷提升公司的財務實力。例如，最近我們透過整合馬裡蘭州校區，獲得了 6,000 萬美元的短期現金收入，並預計長期可節省約 2.3 億美元。

With this steady progress since 2023 to transform our company, we are now in a new phase of opportunity for Novavax. As we look ahead, the work we are doing now is intended to position the company well for a period of long-term growth and profitability. The intent is for this growth to be driven by a growing and diversified revenue base that stems from multiple partnerships, milestones, royalty streams, and our emerging R&D portfolio.

自 2023 年以來，我們穩步推進公司轉型，現在 Novavax 迎來了一個新的發展機會階段。展望未來，我們現在所做的工作旨在使公司為長期成長和獲利做好充分準備。我們的目標是透過不斷增長和多元化的收入基礎來推動這一增長，而這一收入基礎源於多項合作關係、里程碑、特許權使用費收入以及我們正在開發的研發項目組合。

Assuming continued execution of our plan and by our partners, both existing and new, we are executing toward a future for Novavax in which we have the potential to achieve non-GAAP profitability as early as 2028.

假設我們的計劃以及現有和新的合作夥伴繼續執行，我們將朝著 Novavax 的未來邁進，並有可能最早在 2028 年實現非 GAAP 盈利。

During this time of transition, before we reach our intended goal of profitability, we expect our revenue mix to change as we rely on milestone payments in the midterm to bridge to an increased emphasis on licensing and royalty revenue, which we expect to grow over time, both in magnitude and in the number and diversity of our royalty streams.

在實現盈利目標的過渡時期，我們預計收入結構將發生變化，因為我們將在中期依靠里程碑付款來過渡到更加重視許可和特許權使用費收入，我們預計這些收入將隨著時間的推移而增長，無論是在規模上還是在特許權使用費來源的數量和多樣性上。

With this as our focus, our 2025 priorities to advance our strategy and grow shareholder value are threefold: number one, optimizing our partnership with Sanofi; number two, enhancing existing partnerships and leveraging our technology platform and pipeline to forge additional partnerships; and number three, advancing our technology platform and early-stage pipeline.

以此為重點，我們2025年推進策略和提升股東價值的優先事項有三點：第一，優化與賽諾菲的合作關係；第二，加強現有合作關係，並利用我們的技術平台和產品線建立更多合作關係；第三，推進我們的技術平台和早期產品線。

Across all three of these priorities, we have made significant progress in the third quarter. In our partnership with Sanofi, we have achieved all milestones expected for 2025, securing a total of $225 million for the year from the BLA approval for Nuvaxovid and including $50 million from the successful transfer of our marketing authorizations in both the U.S. and the EU.

在上述三個優先事項中，我們在第三季都取得了顯著進展。在與賽諾菲的合作中，我們實現了 2025 年預期的所有里程碑，從 Nuvaxovid 的 BLA 批准中獲得了 2.25 億美元的年度收入，其中包括從我們在美國和歐盟成功轉讓市場授權中獲得的 5000 萬美元收入。

We also completed the transfer to Sanofi of lead commercial responsibility for the U.S., allowing us to fully discontinue our own sales and marketing efforts this year for Nuvaxovid. On their recent earnings call, Sanofi stated that 2025 marks an important transition year for Nuvaxovid with their full commercial launch in the U.S. and select other global markets expected for the '26-'27 season.

我們也完成了將美國主要商業責任移交給賽諾菲的工作，這使得我們今年可以完全停止我們自己對Nuvaxovid的銷售和行銷工作。在最近的財報電話會議上，賽諾菲表示，2025 年是 Nuvaxovid 的一個重要過渡年，預計將在 2026-2027 年在美國和其他一些全球市場全面商業化上市。

Beyond Nuvaxovid, Novavax is also eligible to receive milestones and royalties associated with the development of new combination vaccines that include Nuvaxovid. Recently, Sanofi indicated preliminary positive Phase I/II safety and immunogenicity data for both of their combination products featuring Nuvaxovid and their approved flu vaccines and are planning to engage with regulators on next steps.

除了 Nuvaxovid 之外，Novavax 還有資格獲得與包含 Nuvaxovid 的新組合疫苗的開發相關的里程碑付款和特許權使用費。最近，賽諾菲公佈了其兩款含有 Nuvaxovid 和已獲批准的流感疫苗的組合產品的初步 I/II 期安全性和免疫原性數據，併計劃與監管機構就下一步措施進行磋商。

And finally, the agreement with Sanofi enables them to develop new vaccines using our Matrix-M adjuvant. Though we cannot speak for our partners regarding any specifics on their plans and activities here, we can say that they are exploring the potential of Matrix-M across several early-stage pipeline programs, and we look forward to any potential opportunities emerging over time from these efforts.

最後，與賽諾菲的協議使他們能夠使用我們的 Matrix-M 佐劑開發新的疫苗。雖然我們不能代表我們的合作夥伴就其計劃和活動的具體細節發表意見，但我們可以說，他們正在探索 Matrix-M 在多個早期研發項目中的潛力，我們期待隨著時間的推移，這些努力能夠帶來任何潛在的機會。

In addition to our partnerships with Sanofi and Takeda, our partnership with Serum and Oxford University on the R21/Matrix-M malaria vaccine continues to make an impact on global public health. Through September of this year, approximately 25 million doses of R21/Matrix-M vaccine have been distributed to about 24 countries in Africa, with the most recent launch in Zambia announced a couple of weeks ago.

除了與賽諾菲和武田的合作之外，我們與印度血清研究所和牛津大學在 R21/Matrix-M 瘧疾疫苗方面的合作也持續對全球公共衛生產生影響。截至今年 9 月，約有 2,500 萬劑 R21/Matrix-M 疫苗已分發至非洲約 24 個國家，最近一次在尚比亞啟動是在幾週前。

This is a much-needed option for a region where malaria continues to be one of the continent's most persistent public health threats with economic and social impacts, historically killing over 600,000 people annually, and disproportionately impacting children under five in sub-Saharan Africa. We are very proud that our technology is a critical component of this important solution for global public health.

對於瘧疾仍然是非洲大陸最頑固的公共衛生威脅之一，造成經濟和社會影響的地區來說，這是一個非常必要的選擇。歷史上，瘧疾每年導致超過 60 萬人死亡，對撒哈拉以南非洲五歲以下兒童的影響尤其嚴重。我們非常自豪，我們的技術是這項關乎全球公共衛生的重要解決方案的關鍵組成部分。

Our strong performance as a partner helps to set the stage for future potential collaborations to generate additional meaningful royalty streams for Novavax for years to come. In the global vaccine market that is expected to grow over the next 10 years, we believe that Novavax is well positioned to capitalize on this growth by continuing to leverage our technology and expertise to tackle some of the world's most significant health challenges. Finally, during the quarter, our R&D team continued to make progress in advancing our early-stage pipeline. So, at this point, I'd like to turn the call over to Ruxandra to share more.

我們作為合作夥伴的出色表現，有助於為未來潛在的合作奠定基礎，從而在未來幾年為 Novavax 創造更多有意義的版稅收入。預計未來 10 年全球疫苗市場將持續成長，我們相信 Novavax 將繼續利用我們的技術和專業知識來應對世界上一些最重大的健康挑戰，以充分利用這一成長機會。最後，在本季度，我們的研發團隊在推動早期產品線方面持續取得進展。那麼，接下來我想把電話交給魯克桑德拉，讓她分享更多。

Thank you, John. Please turn to Slide 7. I'm excited to share more about our progress in R&D. I'm just returning from several of the quarter's key medical meetings during which I've had the opportunity to discuss and reflect on the current trends in vaccination.

謝謝你，約翰。請翻到第7頁投影片。我很高興與大家分享我們在研發方面所取得的進展。我剛參加完本季幾個重要的醫學會議回來，期間我有機會討論和思考疫苗接種的當前趨勢。

As you know, infectious diseases know no borders and the need for vaccination is no different. While the need for vaccination globally remains constant, we know that regional differences in actual vaccination rates as well as vaccine confidence can fluctuate greatly.

如你所知，傳染病不分國界，接種疫苗的必要性也不例外。雖然全球對疫苗的需求保持不變，但我們知道，實際疫苗接種率以及對疫苗的信心在不同地區之間可能會出現很大波動。

This is a phenomenon known since the introduction of the first vaccine, the smallpox vaccine. Vaccine confidence is a leading indicator of vaccination rates and varies worldwide, influenced by political, historical, cultural, and socioeconomic factors, with highs and lows, sometimes varying as much as 50% to 60% in the same region or country year-to-year.

這種現象自第一種疫苗──天花疫苗問世以來就已為人所知。疫苗信心是疫苗接種率的領先指標，在全球範圍內因政治、歷史、文化和社會經濟因素而異，有高峰也有低谷，有時在同一地區或國家，每年的波動幅度可達 50% 至 60%。

This is something we have seen in the flu and other vaccine markets over the years and to some degree, more recently in the United States with RSV, shingles, measles, COVID-19, and other vaccines, so it is reasonable to expect that vaccination rates could improve in the future.

多年來，我們在流感和其他疫苗市場都看到了這種情況，而且在某種程度上，最近在美國的呼吸道合胞病毒、帶狀皰疹、麻疹、新冠肺炎和其他疫苗市場也出現了這種情況，因此有理由預期未來的疫苗接種率會有所提高。

Additionally, many recent reports, such as those from McKinsey and others, have estimated that the global vaccine market could steadily grow at an average annual rate of 6% to 8% to reach a size of over $75 billion by 2030.

此外，麥肯錫等機構近期發布的許多報告估計，到 2030 年，全球疫苗市場可能會以平均每年 6% 至 8% 的速度穩步增長，達到 750 億美元以上。

Coming back to recent medical meetings, I had the opportunity to speak more about our technology and its incredible potential. I am energized by the reception received from colleagues, researchers, and industry participants at this meeting. Like us, they see the potential of our technology in both new and existing vaccines and are excited to watch our early-stage programs evolve.

回到最近的醫學會議，我有機會更多地談論我們的技術及其巨大的潛力。我對同事、研究人員和產業參與者在本次會議上給予的正面回應感到振奮。和我們一樣，他們看到了我們技術在新型疫苗和現有疫苗方面的潛力，並很高興看到我們的早期計畫不斷發展。

One of the key topics we have been presenting on has been the continued assessment of the tolerability profile of Matrix-M-containing vaccines, a key differentiator of our vaccine platform. For example, active comparator studies of Nuvaxovid versus mRNA COVID vaccines revealed lower frequencies and intensities of local and solicited adverse effects and lower impact of reactogenicity on quality-of-life measures among our vaccines recipients.

我們一直在介紹的一個關鍵主題是持續評估含 Matrix-M 疫苗的耐受性特徵，這是我們疫苗平台的關鍵區別因素。例如，Nuvaxovid 與 mRNA COVID 疫苗的主動對比研究表明，Nuvaxovid 疫苗的局部不良反應和主動報告不良反應的發生頻率和強度較低，疫苗接種者的反應原性對生活品質指標的影響也較小。

These findings are consistent with systematic review and meta-analysis which are expected to be published in the near future and are important because we expect that, that improved tolerability associated with comparable, if not better efficacy and durability, is likely to lead to higher rates of vaccine uptake.

這些發現與系統性回顧和統合分析的結果一致，預計這些評估和薈萃分析將在不久的將來發表，而且這些發現非常重要，因為我們預期，耐受性提高，同時療效和持久性達到相當甚至更高水平，可能會提高疫苗的接種率。

Please turn to Slide 8. During the quarter, we have been making continued progress on our four current early preclinical vaccine candidates: C. diff, shingles, RSV combination, and pandemic influenza. We are continuing to refine these candidates, investing smartly and using AI and machine learning to rapidly and cost effectively inform design, create new antigen, and then test to help prepare the assets for clinical work as programs progress.

請翻到第8頁幻燈片。本季度，我們在四個目前的早期臨床前疫苗候選藥物方面取得了持續進展：艱難梭菌疫苗、帶狀皰疹疫苗、呼吸道合胞病毒聯合疫苗和流感大流行疫苗。我們正在不斷改進這些候選藥物，進行明智的投資，並利用人工智慧和機器學習來快速、經濟高效地指導設計、創建新抗原，然後進行測試，以幫助為臨床工作做好準備，隨著計畫的推進，這些藥物將投入臨床應用。

I will provide a brief update of each program. Our C. diff vaccine candidate targets a major pathogen responsible for antibiotic-associated diarrhea, frequently observed in hospital settings. The incidence and severity of C. diff infections are rising across the world with no approved vaccine.

我將簡要介紹每個專案的最新進展。我們的艱難梭菌疫苗候選物針對的是一種導致抗生素相關性腹瀉的主要病原體，這種腹瀉在醫院環境中經常出現。艱難梭菌感染的發生率和嚴重程度在全球範圍內不斷上升，目前尚無核准疫苗。

For our work on the shingles program, we are advancing two different activated protein antigens with Matrix-M. Early preclinical results suggest both induced immunogenicity and, as anticipated, potentially a better reactogenicity profile.

在帶狀皰疹計畫中，我們正在利用 Matrix-M 進行兩種不同的活化蛋白質抗原的研究。早期臨床前結果表明，該產品既能誘導免疫原性，而且正如預期的那樣，可能具有更好的反應原性。

Finally, we believe that our RSV combination program has the potential to meet the desire of both the public and health care providers for combination vaccines that can address multiple respiratory viruses at once. For all three programs, we have exciting preclinical data that is beginning to emerge and further indicate the potential of our technology platform to make a difference in these critical areas of unmet need. We look forward to sharing more with you in the coming quarters as our initial datasets from these early programs begin to crystallize.

最後，我們相信我們的 RSV 聯合疫苗計劃有可能滿足公眾和醫療保健提供者對能夠同時對抗多種呼吸道病毒的聯合疫苗的需求。對於這三個項目，我們都有令人興奮的臨床前數據開始湧現，這些數據進一步表明我們的技術平台有潛力在這些尚未滿足的關鍵需求領域中發揮作用。隨著這些早期專案的初始資料集逐漸清晰，我們期待在接下來的幾季與您分享更多資訊。

Our Matrix-M adjuvant in pandemic influenza vaccine candidate shows promise in potentially being able to deliver a single-dose vaccine option that can be given either intramuscularly or intranasally to protect against pandemic influenza infection in individuals who had a previous exposure to seasonal influenza or received a seasonal influenza vaccine.

我們的 Matrix-M 佐劑在大流行性流感疫苗候選產品中顯示出希望，有可能提供一種單劑量疫苗選擇，可透過肌肉注射或鼻內注射，以保護以前接觸過季節性流感或接種過季節性流感疫苗的個體免受大流行性流感感染。

This benefit may be critically important in the context of a future public health emergency given options for administration and fewer doses needed for protection. We are actively seeking funding from government programs to test our vaccine candidates in clinical trials.

考慮到給藥方式的選擇以及達到防護所需的劑量較少，這種益處在未來的公共衛生緊急情況下可能至關重要。我們正在積極尋求政府計畫的資金支持，以開展疫苗候選產品的臨床試驗。

Matrix-M has been proven to provide positive clinical benefits in infectious diseases, and we are excited about our early progress with the new pipeline of programs in both viral and bacterial applications. As noted earlier, a key component of our corporate strategy is to leverage our technology platform and to diversify both within and beyond infectious diseases.

Matrix-M 已被證明在傳染病治療中具有積極的臨床療效，我們對在病毒和細菌應用方面的新項目管線的早期進展感到非常興奮。如前所述，我們公司策略的關鍵組成部分是利用我們的技術平台，並在傳染病領域內外多元化發展。

For example, since January, we have begun early work to explore the potential utility of our adjuvant, including new formulations, in oncology. Our early clinical work is aligned with our corporate strategy and is supportive of ongoing discussions with both existing and potential partners.

例如，自 1 月以來，我們已經開始早期研究，探索我們的佐劑（​​包括新配方）在腫瘤學中的潛在用途。我們早期的臨床工作與我們的企業策略一致，並支持與現有和潛在合作夥伴的持續討論。

We continue to progress these relationships with the goal of developing new partnerships, and in doing so, new vaccines or improving existing vaccines, that could have a positive impact on global health for decades to come. I look forward to continuing to update you on each of these exciting programs as more data becomes available. I'll turn the call to Jim now.

我們將繼續推動這些關係，目標是發展新的夥伴關係，並在此過程中研發出新的疫苗或改進現有疫苗，從而在未來幾十年內對全球健康產生積極影響。隨著更多數據的公佈，我期待繼續向大家報告這些令人興奮的項目的最新進展。我現在把電話轉給吉姆。

All right. Thank you, Rux. Please turn to Slide 9. This morning, we announced our financial results for the third quarter of 2025. Details of our results can be found in our press release issued today and in our Form 10-Q filed with the SEC.

好的。謝謝你，魯克斯。請翻到第9頁投影片。今天上午，我們公佈了2025年第三季的財務表現。有關我們業績的詳細信息，請參閱我們今天發布的新聞稿以及我們向美國證券交易委員會提交的 10-Q 表格。

Please turn to Slide 10. I'll begin with key highlights from our third quarter 2025 financial results. We reported total revenue of $70 million, and importantly, Sanofi has now taken on the lead commercial role for Nuvaxovid in the U.S. and select ex-U.S. markets.

請翻到第10頁投影片。我將首先介紹我們 2025 年第三季財務業績的幾個關鍵亮點。我們報告的總收入為 7000 萬美元，更重要的是，賽諾菲現在已在美國和部分美國以外市場承擔了 Nuvaxovid 的主要商業角色。

Sanofi recorded $23 million in Nuvaxovid sales in the third quarter of 2025 and reiterated that 2025 is a transition year as they establish their commercial capabilities in the U.S. Novavax has recorded $4 million in royalties related to these sales in the quarter.

賽諾菲在 2025 年第三季錄得 Nuvaxovid 銷售額 2,300 萬美元，並重申 2025 年是過渡年，因為他們正在美國建立商業能力。 Novavax 在該季度錄得與這些銷售相關的 400 萬美元特許權使用費。

During the third quarter of 2025, we continued to transform Novavax into a more lean and agile organization. For example, this quarter saw an 18% reduction in our combined R&D and SG&A costs compared to the same period last year.

2025 年第三季度，我們繼續將 Novavax 轉型為一個更精簡和靈活的組織。例如，本季我們的研發和銷售、管理及行政費用合計比去年同期減少了 18%。

And of note, we reduced SG&A by 55% as we reduced commercial and general infrastructure spending. In October, we announced a set of transactions that enable Novavax to further consolidate our Maryland sites and is expected to result in $60 million in cash proceeds by the first quarter of 2026 and approximately $230 million in cost avoidance over the next 11 years.

值得注意的是，由於我們減少了商業和一般基礎設施支出，銷售、管理及行政費用減少了 55%。10 月，我們宣布了一系列交易，使 Novavax 能夠進一步整合我們在馬裡蘭州的工廠，預計到 2026 年第一季將獲得 6000 萬美元的現金收益，並在未來 11 年內避免約 2.3 億美元的成本。

Investors will see $126 million in noncash charges in the current quarter related to this Maryland site consolidation and the convertible debt financing transactions, emphasizing that these are noncash in nature and each transaction serves to materially improve our financial strength as we execute on our growth strategy.

投資者將在本季度看到與馬裡蘭州站點整合和可轉換債券融資交易相關的 1.26 億美元非現金支出，這強調了這些支出本質上是非現金的，並且每筆交易都有助於在執行增長戰略的過程中實質性地提高我們的財務實力。

Novavax ended the third quarter with $812 million in cash and accounts receivable. This is prior to factoring in an additional $110 million earned for MAH transfers and Maryland site transactions announced in the fourth quarter. Year-to-date, Sanofi milestones earned of $225 million is consistent with our 2025 revenue framework and includes the $50 million earned related to the U.S. and EU MAH transfers.

Novavax第三季末現金及應收帳款餘額為8.12億美元。這還不包括第四季度宣布的 MAH 轉讓和馬裡蘭州場地交易所獲得的額外 1.1 億美元收入。今年迄今為止，賽諾菲已實現的里程碑收入為 2.25 億美元，與我們的 2025 年收入框架一致，其中包括與美國和歐盟 MAH 轉讓相關的 5,000 萬美元收入。

Please turn to Slide 11 for a detailed review of our third quarter revenue results. For the third quarter of 2025, we recorded total revenue of $70 million compared to $85 million in the same period of 2024. Product sales for the third quarter of 2025 of $13 million comes from COVID vaccine and Matrix-M supply sales to our license partners and reflects a change to our business model as we now primarily support our license partners who market products that leverage our technology platform.

請翻到第 11 頁，詳細了解我們第三季的營收表現。2025 年第三季度，我們的總收入為 7,000 萬美元，而 2024 年同期為 8,500 萬美元。2025 年第三季產品銷售額為 1,300 萬美元，主要來自 COVID 疫苗和 Matrix-M 供應品的銷售，銷售對象為我們的授權合作夥伴。這反映了我們業務模式的轉變，因為我們現在主要支援我們的授權合作夥伴，他們銷售的產品利用了我們的技術平台。

Licensing royalties and other revenue of $57 million in the third quarter of 2025 was primarily from our Sanofi agreement and includes $46 million of R&D reimbursement and $4 million of royalties from the sales of Nuvaxovid.

2025 年第三季的授權費和其他收入為 5,700 萬美元，主要來自我們與賽諾菲的協議，其中包括 4,600 萬美元的研發補償金和 400 萬美元的 Nuvaxovid 銷售特許權使用費。

Please turn to Slide 12 for a detailed view of our third quarter financial results where I'll focus on our operating expense results and trends. Third quarter 2025 combined R&D and SG&A expenses were $130 million and reflected an 18% reduction from the same period in 2024.

請翻到第 12 頁，詳細查看我們第三季的財務業績，我將重點介紹我們的營運費用結果和趨勢。2025 年第三季研發與銷售、管理及行政費用合計為 1.3 億美元，比 2024 年同期減少了 18%。

While our R&D spend of $98 million exceeds the prior year, $46 million, or almost half, is subject to reimbursement by Sanofi. Importantly, our SG&A expenses were 55% lower than the same period last year and are driven by the transition of lead global commercial activities to Sanofi plus strong execution on our broader cost reduction plan.

雖然我們9,800萬美元的研發支出超過了去年，但其中4,600萬美元（幾乎是一半）需要賽諾菲報銷。值得注意的是，我們的銷售、一般及行政費用比去年同期下降了 55%，這主要得益於全球主要商業活動向賽諾菲的轉移，以及我們更廣泛的成本削減計劃的有力執行。

During the third quarter of 2025, we incurred noncash charges totaling $126 million, inclusive of a $97 million asset impairment related to our Maryland site consolidation and $29 million related to loss on debt extinguishment for the convertible debt refinancing.

2025 年第三季度，我們產生了總計 1.26 億美元的非現金支出，其中包括與馬裡蘭州工廠整合相關的 9,700 萬美元資產減值，以及與可轉換債券再融資的債務清償損失相關的 2,900 萬美元。

The convertible debt refinancing in August extended the maturity of the majority of the 2027 notes to 2031 with improved terms. This transaction supports Novavax's financial strength during a key transition period for the company. And finally, we reported a net loss of $202 million, or $1.25 per diluted share, for the third quarter of 2025.

8 月的可轉換債券再融資將大部分 2027 年到期的債券的到期日延長至 2031 年，並改善了條款。此交易有助於 Novavax 在公司關鍵轉型期保持財務實力。最後，我們公佈了 2025 年第三季淨虧損 2.02 億美元，即每股攤薄虧損 1.25 美元。

Please turn to Slide 13. We're committed to streamlining our operating expenses to enable value creation. We are reaffirming our full year 2025 financial guidance for combined R&D and SG&A expenses of $520 million at the midpoint and narrowing the range to $505 million to $535 million.

請翻到第13頁投影片。我們致力於精簡營運費用，以實現價值創造。我們重申 2025 年全年研發和銷售、管理及行政費用的財務預期，中位數為 5.2 億美元，並將範圍縮小至 5.05 億美元至 5.35 億美元。

On a non-GAAP basis and net of partner reimbursement, we now expect full year 2025 R&D and SG&A to be approximately $450 million at midpoint. This reflects an approximately $15 million improvement versus the prior estimate of approximately $465 million.

依非GAAP準則並扣除合作夥伴補償後，我們現在預計2025年全年研發及銷售、管理及行政費用中位數約為4.5億美元。這比先前估計的約 4.65 億美元減少了約 1500 萬美元。

We are also reaffirming our multiyear targets for 2026 and 2027 combined R&D and SG&A expenses, net of partner reimbursements, of $350 million and $250 million, respectively. We believe that providing both the gross spend and net of partner reimbursement views provides investors with a better understanding of our core operating cost structure.

我們也重申了2026年和2027年研發和銷售、管理及行政費用（扣除合作夥伴報銷）的多年目標，分別為3.5億美元和2.5億美元。我們認為，同時提供總支出和扣除合作夥伴報銷後的淨支出情況，能夠讓投資者更了解我們的核心營運成本結構。

We are awaiting our license partners to complete their 2026 planning processes to better understand if there are any new updates to our R&D support. We do not expect potential updates to impact our core spend targets net of reimbursement outlined today.

我們正在等待授權合作夥伴完成 2026 年規劃流程，以便更了解我們的研發支援是否有任何新的更新。我們預計潛在的更新不會影響我們今天概述的扣除報銷後的核心支出目標。

Please turn to Slide 14 for a recap of sources of 2024 and 2025 cash flow earned through November 2025. During 2024 and 2025, we significantly improved Novavax's financial strength by securing $1.4 billion in new cash for the company while in parallel reducing our cost structure and liabilities.

請翻到第 14 頁，查看截至 2025 年 11 月的 2024 年和 2025 年現金流來源的回顧。在 2024 年和 2025 年，我們透過為公司籌集 14 億美元的新現金，同時降低成本結構和負債，顯著提高了 Novavax 的財務實力。

$1.1 billion or 78% of this cash came from nondilutive sources, including partner upfronts and milestones plus sale of assets. Important to note, we have not raised equity capital from our ATM facility since the second quarter of 2024 as we prioritize nondilutive funding sources and cost reductions.

其中 11 億美元（佔 78%）現金來自非稀釋性來源，包括合作夥伴預付款和里程碑付款以及資產出售。值得注意的是，自 2024 年第二季以來，我們沒有透過 ATM 融資管道籌集股權資本，因為我們優先考慮非稀釋性融資來源和成本削減。

Please turn to Slide 15. Now turning to our 2025 revenue framework. Today, we are raising our prior revenue framework by $25 million at the midpoint and now expect to achieve adjusted total revenue of between $1.040 billion to $1.060 billion.

請翻到第15頁投影片。現在來看我們2025年的收入框架。今天，我們將先前的收入框架中點提高了 2500 萬美元，現在預計調整後的總收入將在 10.4 億美元至 10.6 億美元之間。

Our 2025 revenue framework excludes Sanofi supply sales, royalties, 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.

我們的 2025 年收入框架不包括賽諾菲的供應銷售額、特許權使用費、流感 COVID-19 組合和 Matrix-M 相關里程碑。這意味著 2025 年可能會出現一些收入，這些收入會增加我們對該年度調整後總收入的預期。

At midpoint, the $25 million increase to our 2025 adjusted total revenue is driven by a $7.5 million increase to adjusted supply sales related to increased demand for Matrix-M from Serum for the R21/Matrix-M malaria vaccine, a $12.5 million increase to Sanofi cost reimbursement related to ongoing R&D activities, and a $5 million increase to other partner revenue related to Serum and Takeda royalties.

截至年中，我們 2025 年調整後總收入增加 2500 萬美元，主要得益於以下因素：由於 Serum 公司對 R21/Matrix-M 瘧疾疫苗的 Matrix-M 需求增加，調整後供應銷售額增加 750 萬美元；由於正在進行的研發活動，賽諾菲公司成本成本增加 1250 萬美元； 500 萬美元。

Please turn to Slide 16 for a preview of our 2026 revenue framework. For 2026, we are following an approach similar to the 2025 revenue framework, in that our non-GAAP adjusted total revenue excludes Sanofi royalties, CIC milestones, COVID-19 supply sales, and Novavax COVID-19 APA sales.

請翻到第 16 頁，預覽我們的 2026 年收入架構。對於 2026 年，我們採用與 2025 年收入框架類似的方法，即我們的非 GAAP 調整總收入不包括賽諾菲特許權使用費、CIC 里程碑付款、COVID-19 供應銷售額和 Novavax COVID-19 APA 銷售額。

This means there may be revenues in 2026 that are additive to our expectations for adjusted licensing, royalty, and other revenue. That said, we believe that the '26-'27 season Nuvaxovid royalties will grow significantly as compared to 2025 as next year reflects the first full year where Sanofi will have the opportunity to prepare for its marketing and contracting efforts and build upon the learnings from the current transition year in the U.S. and markets outside the U.S.

這意味著 2026 年可能會出現一些額外收入，這些收入將超出我們對調整後授權費、特許權使用費和其他收入的預期。也就是說，我們相信，與 2025 年相比，2026-2027 年度 Nuvaxovid 的特許權使用費將大幅增長，因為明年是賽諾菲有機會為其市場營銷和合約工作做好準備的第一個完整年度，並在美國和美國以外的市場，根據當前過渡年的經驗教訓進行改進。

This preliminary preview is intended to help investors better track the Novavax transition period revenues under our Sanofi agreement. Investors should not anticipate a similar update at this time next year as these activities are expected to be materially completed by the end of 2026.

這份初步預覽旨在幫助投資者更好地追蹤根據我們與賽諾菲的協議，Novavax 過渡期的收入。投資者不應期望明年此時會有類似的更新，因為這些活動預計將在 2026 年底前基本完成。

For 2026, we expect to achieve adjusted total revenue of between $185 million and $205 million. This includes: a $75 million milestone from the completion of manufacturing technology transfer expected to be earned in the fourth quarter of 2026; $30 million to $40 million in R&D reimbursement as we complete our R&D support and technology transfer activities for Sanofi; $30 million to $40 million of adjusted supply sales to our license partners, which primarily reflect sales of Matrix-M; and finally, $50 million of noncash amortization related to the previously received upfront and R&D milestone payments from Sanofi. In the case of both R&D reimbursement and adjusted supply sales, these preliminary ranges are subject to the completion of our license partners' plans for 2026.

預計到 2026 年，調整後的總收入將在 1.85 億美元至 2.05 億美元之間。這包括：預計在 2026 年第四季完成製造技術轉移後獲得的 7,500 萬美元里程碑付款；在我們完成對賽諾菲的研發支援和技術轉移活動後獲得的 3,000 萬至 4,000 萬美元研發報銷款；向我們的許可合作夥伴支付的 3,000 萬至 4000 萬美元銷售額，主要調整了 Matrix-M 供應的銷售額；以及最後，與先前從賽諾菲收到的預付款和研發里程碑付款相關的 5000 萬美元非現金攤銷。無論是研發報銷或調整後的供應銷售，這些初步範圍都取決於我們的授權合作夥伴 2026 年計畫的完成情況。

When comparing our non-GAAP adjusted total revenue for 2026 to 2025, please note that 2025 includes $610 million in noncash product sales related to the settlement of APA agreements. While currently excluded from our 2026 adjusted total revenue, there is the potential for a $125 million milestone linked to the initiation of a Phase III CIC program and its addition is pending feedback from Sanofi regarding clinical plans for their CIC programs.

在比較我們 2026 年和 2025 年的非 GAAP 調整後總收入時，請注意，2025 年包括與 APA 協議結算相關的 6.1 億美元的非現金產品銷售額。雖然目前尚未計入我們 2026 年調整後的總收入，但與啟動 III 期 CIC 項目相關的里程碑收入可能達到 1.25 億美元，而是否將其納入計算，取決於賽諾菲對其 CIC 項目臨床計劃的反饋。

We are encouraged by the recent Sanofi announcement of preliminary positive results from both of their CIC Phase I/II programs and their intent to engage with regulatory authorities to advance development.

我們對賽諾菲近期宣布其兩項 CIC I/II 期項目取得的初步積極結果以及其與監管機構合作推進研發的意願感到鼓舞。

As Novavax drives towards our goal of non-GAAP profitability, we expect this could occur as early as 2028. Key to the timing of our path to non-GAAP P&L profitability are the successful development and regulatory approval of the Sanofi CIC program and successful commercial execution by Sanofi on both the COVID and CIC programs.

隨著 Novavax 朝著非 GAAP 盈利的目標邁進，我們預計最快可能在 2028 年實現這一目標。我們實現非GAAP損益獲利的關鍵在於賽諾菲CIC專案的成功開發和監管批准，以及賽諾菲在COVID和CIC專案上的成功商業化執行。

This could be further supported by our expectation that we will add additional cash flow from new business development agreements. We look forward to sharing additional updates as we improve Novavax's financial performance, cost structure, and strength to deliver shareholder value.

我們預期新的業務發展協議將帶來額外的現金流，這可以進一步佐證上述觀點。我們期待在諾瓦瓦克斯財務表現、成本結構和為股東創造價值的能力不斷提升的過程中，與大家分享更多最新進展。

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

接下來，我想把電話交還給約翰，請他做些總結發言。

Thank you, Jim.

謝謝你，吉姆。

In summary, we're proud of the continued progress being made on our corporate strategy with a consistent track record of execution to date. We are seeing continued success across our strategic priorities for the year, including optimizing our partnership with Sanofi, enhancing other existing partnerships, and working to forge new potential collaborations.

總而言之，我們對公司策略的持續進展以及迄今為止始終如一的執行記錄感到自豪。我們今年的各項策略重點都持續成功，包括優化與賽諾菲的合作關係、加強其他現有合作關係、努力建立新的潛在合作關係。

We've been advancing our early-stage pipeline and working to expand the utility of our technology platform. This is all underpinned by a continued focus on further improving our financial foundation while ensuring we have the right capabilities to successfully execute our strategy into the future.

我們一直在推動早期研發管線，並努力擴大我們技術平台的用途。這一切都建立在我們持續專注於進一步改善財務基礎，同時確保我們擁有在未來成功執行策略所需的能力之上。

We remain committed to our growth strategy and believe that it puts us on the best path to deliver long-term sustainable value for our shareholders. Our progress to date has set us on the right path heading into the year-end and into 2026, and we remain excited about the future of Novavax.

我們將繼續致力於我們的成長策略，並相信這將使我們走上為股東創造長期永續價值的最佳道路。我們迄今為止的進展使我們走上了正確的道路，邁向年底和 2026 年，我們對 Novavax 的未來仍然充滿信心。

Thank you to our shareholders for their support. And as always, we appreciate all of the hard work and dedication of our employees without whom the success would not be possible.

感謝各位股東的支持。一如既往，我們感謝所有員工的辛勤工作和奉獻精神，沒有他們，我們不可能取得成功。

I'd now like to turn the call over to our operator for Q&A. Operator?

現在我將把電話轉交給我們的接線生進行問答環節。操作員？

(Operator Instructions) Roger Song, Jefferies.

（操作說明）羅傑‧宋，傑富瑞。

This is Nabeel on for Roger. Maybe two from us. How do you see the 2025 COVID season as compared to last year? Are you getting any feedback from pharmacies on stocking and consumer preference for the product? And then could you provide some more color on that BARDA grant? And does it reflect any attitude from the FDA?

這裡是納比爾替羅傑報道。也許我們能拿出兩個。您認為2025年的新冠疫情與去年相比會如何？你們有沒有收到藥局關於該產品進貨狀況和消費者偏好的回饋？那麼，您能否再詳細介紹BARDA的撥款情況？這是否反映了美國食品藥物管理局（FDA）的某種態度？

Thank you for your questions. Jim, did you want to take that?

謝謝你的提問。吉姆，你想拿那個嗎？

Certainly. Why don't I begin -- and thanks for the question about the COVID season. And by the way, a lot of credit to Jefferies. You put out an exceptional COVID [ tracker ] every week. And so what I'll do is, for all your customers, I'm going to reference it. I know it's a lot of IQVIA data, but you do exceptional work.

當然。那我就先開始了——謝謝你問到關於新冠疫​​情的問題。順便說一句，傑富瑞功不可沒。你們每週都會發布一份非常出色的新冠疫情追蹤報告。因此，我會向你們所有的客戶推薦它。我知道這是大量的 IQVIA 數據，但你的工作非常出色。

And then on the BARDA piece, which I think is referencing the new pandemic flu BARDA grant to Sanofi, I'm going to speak -- have Rux speak to that and some of the latest on the pandemic flu front. All right. So beginning with the COVID season, as folks know, especially in the U.S., we had a policy update this year, certainly more restrictive in the below-65 age groups.

然後是關於 BARDA 的部分，我認為這是指 BARDA 向賽諾菲提供的新的流感大流行資助，我將發言——讓 Rux 談談這部分以及流感大流行方面的最新進展。好的。因此，正如大家所知，尤其是在美國，從新冠疫情開始，我們今年更新了政策，對 65 歲以下年齡層的限制更加嚴格。

When we look at the year-over-year, and I think folks know we started one week late, so if you adjust for that, the season in terms of Rxs are down about 20% compared to last year. That's fairly consistent, at least, I'll say, with our internal analytics and expectation for how ours and actually others in this market, how their labels have been altered.

當我們從同比數據來看，我想大家都知道我們今年晚了一周才開始，所以如果考慮到這一點，本季的處方藥銷量比去年下降了約 20%。至少可以說，這與我們內部的分析和預期相當一致，即我們以及市場上其他公司的標籤是如何改變的。

So, when you think about the label for COVID then in the U.S., it's beginning to become far more aligned to Europe and global markets. So, when we think about the COVID market this year and its go-forward expectations, there's just a bit of a resetting occurring in the U.S. and then our expectation is you build from there with a sound footing.

所以，當你思考美國對 COVID-19 的標籤時，你會發現它正變得越來越接近歐洲和全球市場。所以，當我們思考今年的 COVID 市場及其未來預期時，美國正在經歷一次調整，我們預計你們將以此為基礎，並在此基礎上繼續發展。

So that's some of the feedback on the COVID market. And we're really looking forward to Sanofi and what they're going to be able to do with Nuvaxovid, especially starting next year when they get their full year. But with that said and talking about Sanofi, perhaps, Rux, some feedback on the new BARDA announcement.

以上是關於新冠疫​​情下市場的一些回饋。我們非常期待賽諾菲以及他們能用 Nuvaxovid 做些什麼，特別是從明年開始，當他們獲得完整的一年時。但話說回來，說到賽諾菲，Rux，或許可以就BARDA的新公告提供一些回饋意見。

Yes. Thank you, Jim, and thank you for the question, Roger. So, we are talking here about a BARDA grant that has been awarded to our partners to Sanofi for early-stage work with their vaccine candidate for pandemic influenza, but including our Matrix-M adjuvant.

是的。謝謝你，吉姆；也謝謝你的提問，羅傑。所以，我們在這裡討論的是 BARDA 授予我們合作夥伴賽諾菲的一項撥款，用於其大流行性流感候選疫苗的早期研究，其中也包括我們的 Matrix-M 佐劑。

The companies have announced previously that we've amended our collaboration agreement to include Novavax's Matrix-M adjuvant in this Sanofi's pandemic influenza vaccine candidate. So, this candidate is going to go through Phase II. And as you are, we are very keen in seeing the results and obviously eventually contributing to pandemic influenza preparedness in the United States and elsewhere in the world.

先前，兩家公司已宣布，我們已修改合作協議，將 Novavax 的 Matrix-M 佐劑納入賽諾菲的這款流感大流行疫苗候選產品中。所以，這位候選人將進入第二階段。和你們一樣，我們也非常渴望看到成果，並最終為美國和世界其他地區的流感大流行防範工作做出貢獻。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley Securities。

Yes, good morning. Thanks for taking my questions. Appreciate the detailed R&D updates today. On the Sanofi collaboration, it seems like that's progressing well, including the preliminary positive CIC data they talked about.

是的，早安。謝謝您回答我的問題。感謝今天提供的詳細研發進度報告。與賽諾菲的合作似乎進展順利，包括他們提到的初步積極的 CIC 數據。

Could you talk to your awareness and next steps there? And I also ask since you may have some of your own guidance regarding your CIC program, and it seems from Moderna's earnings this morning, they're still awaiting the FDA feedback on their Phase III CIC package? And also was curious where you stand with your wholly-owned stand-alone flu program? And then I have a quick follow-up.

您能否談談您對此的認識以及下一步計劃？另外，鑑於您可能對您的 CIC 專案有一些指導意見，而且從 Moderna 今天早上的財報來看，他們似乎仍在等待 FDA 對其 III 期 CIC 方案的反饋，我也想問一下？另外，我還想了解貴公司完全自主運作的獨立流感疫苗接種計畫目前進展如何？然後我還有一個簡短的後續問題。

Mayank, thank you for your question. We were very excited to hear Sanofi's announcement in their recent earnings call that they had positive data on both of their combination programs, including their world-leading flu vaccines and our Nuvaxovid.

Mayank，謝謝你的提問。我們非常高興地聽到賽諾菲在最近的財報電話會議上宣布，他們的兩個聯合疫苗項目都取得了積極的數據，其中包括他們世界領先的流感疫苗和我們的Nuvaxovid。

And as our investors, I hope, are well aware, Novavax is eligible for significant future potential royalties and milestones as they initiate a Phase III program, should they do that, and then start to sell that product and market it or [product].

正如我們的投資者所清楚的那樣，如果Novavax啟動三期臨床試驗項目，並開始銷售和推廣該產品，他們將有資格獲得可觀的未來潛在特許權使用費和里程碑付款。[產品]。

Both of those products were fast-tracked by FDA about a year ago. So we're very excited. We can't comment on where they are, but what they did say, we can reference you and our investors to their public commentary that they're approaching the regulator for next steps on that. So we look forward to hearing updates and to them advancing that program, hopefully, to Phase III and beyond.

這兩款產品大約在一年前都獲得了美國食品藥物管理局（FDA）的快速批准資格。所以我們非常興奮。我們無法評論他們的具體位置，但關於他們所說的話，我們可以向您和我們的投資者推薦他們的公開評論，其中提到他們正在與監管機構接洽，以了解下一步措施。因此，我們期待聽到最新消息，並希望他們能推進該項目，希望能夠進入第三階段及以後。

Regarding our own program, what we've said consistently about that, Mayank, is that we intend to outlicense our CIC, our combination COVID flu program that's Phase III ready as well as our flu program, both of those assets and that we continue to seek partners for that and have dialog about that.

關於我們自己的項目，Mayank，我們一直以來的說法是，我們打算將我們的 CIC（新冠病毒流感聯合療法，已進入 III 期臨床試驗）以及我們的流感療法這兩項資產對外授權，並且我們將繼續為此尋找合作夥伴並進行對話。

Not much we can say about that. If we get a partner and do a deal and we sign it, we'll be able to announce it. But that is the intention. And look, we have good data on both of those assets and programs. We think our technology, and believe and have seen it's proven over time, can make a big difference on global public health, and we'll be excited to hopefully see those assets in the hands of another organization someday in the future. That's our intention. We'll keep you posted.

對此我們無可奉告。如果我們找到合作夥伴並達成協議，而且我們簽署了協議，我們就可以宣布此事了。但這正是我們的意圖。而且，我們掌握了關於這兩項資產和項目的可靠數據。我們認為我們的技術，並且相信並已經看到它隨著時間的推移得到了證明，能夠對全球公共衛生產生重大影響，我們期待在未來的某一天，這些資產能夠落入其他組織手中。這就是我們的意圖。我們會隨時向您報告最新情況。

Got it, thank you for that. And then on the rollout of some of the preclinical data that, Rux, you talked about on C. diff, shingles, RSV. Was just curious if these experiments were done, keeping in mind head-to-head comparisons with current available vaccines could be interesting.

明白了，謝謝。然後，Rux，你談到了一些關於艱難梭菌、帶狀皰疹、呼吸道合胞病毒的臨床前數據。我只是好奇是否已經進行了這些實驗，考慮到與現有疫苗進行直接比較可能會很有趣。

And was also curious, we've seen some mixed updates, for example, the Pfizer C. diff vaccine not playing out in terms of events after initial immunogenicity data was strong a couple of years ago. Was curious if you could talk to how we can think of the three programs as investors obviously want to start ascribing value there. And then lastly, just quickly for Jim. On the non-GAAP profitability goal now targeted for 2028, can you just clarify if anything has changed to what you had communicated previously? Thanks for taking questions.

我還注意到，我們看到了一些喜憂參半的更新，例如，輝瑞艱難梭菌疫苗在幾年前的初步免疫原性數據很強之後，在相關事件方面卻沒有取得預期效果。我很好奇您能否談談我們應該如何看待這三個項目，因為投資者顯然希望開始對它們進行估值。最後，簡單說一句給吉姆。關於目前設定的 2028 年非 GAAP 獲利目標，您能否澄清一下，與您先前溝通的內容相比，是否有任何變化？謝謝回答問題。

Thank you, Mike. Rux, do you want to take that first question from Mike on our pipeline?

謝謝你，麥克。Rux，你想回答Mike關於我們管道的第一個問題嗎？

Yes. Thank you, John. So, in our experimentation -- in all our experiments, we are always introducing a negative control and a positive control. For the positive control, we are typically using either approved vaccines, which will serve as, if you want, the guidepost for our experiments, if such vaccines already are approved and on the market, or in the case of, as you were pointing out, C. diff, where an approved vaccine is not yet on the market, we are actually using positive control constructs that are very similar with what competitors have used in their clinical trials. So, every good scientist has to include these negative and positive controls in the experiment. If not, one would not really have the right type of information. So, that's from my side to respond to the first part of your question

是的。謝謝你，約翰。因此，在我們的實驗中—在我們所有的實驗中，我們總是會引入陰性對照和陽性對照。對於陽性對照，我們通常使用已獲批准的疫苗，如果您願意，它們可以作為我們實驗的指導方針（如果此類疫苗已經獲得批准並上市），或者，正如您所指出的艱難梭菌感染，由於尚未有獲批准的疫苗上市，我們實際上使用的是與競爭對手在其臨床試驗中使用的非常相似的陽性對照構建體。因此，每一位優秀的科學家都必須在實驗中加入這些陰性對照和陽性對照。否則，人們就無法真正獲得正確的資訊。以上就是我對你問題第一部分的回答。

Thank you, Ruxandra. And Mayank, thank you for pointing out our three programs, and we're making progress in the lab, early-stage, preclinical, and we're looking forward to in the coming quarters, unveiling some of the learnings.

謝謝你，魯克桑德拉。Mayank，感謝您指出我們的三個項目，我們在實驗室、早期階段和臨床前階段都取得了進展，我們期待在接下來的幾個季度中公佈一些研究成果。

We have some exciting information we're learning internally here where the teams continue to progress that quarter-on-quarter, and we're excited about what we're seeing so far. Beyond the three programs you mentioned, we also have our own pandemic flu initiative.

我們內部了解到一些令人興奮的消息，各個團隊每個季度都在不斷進步，我們對目前為止看到的情況感到非常興奮。除了您提到的三個項目之外，我們還有自己的流感大流行應對計劃。

And our team has been working with both the European and U.S. governmental authorities to seek funding for our own pandemic flu. That's above and beyond what Sanofi may do with our Matrix-M and their flu product. We're also looking at intranasal application potentially for that asset. And so we'll keep you posted as that progresses.

我們的團隊一直在與歐洲和美國政府當局合作，為我們自己的流感大流行尋求資金。這遠遠超出了賽諾菲可能利用我們的 Matrix-M 和他們的流感產品所做的事情。我們也正在考慮將該藥物用於鼻內給藥途徑。我們會隨時向您報告進度。

And in addition, very importantly, we're working on Matrix-M itself to expand its utility, expand the IP around Matrix-M, and its applicability we're exploring in things beyond infectious disease. So we branch beyond just viral antigens to also explore in bacterial, which you mentioned today, and thank you for that. In addition, we're looking to go beyond infectious disease and see what Matrix-M can do.

此外，非常重要的一點是，我們正在對 Matrix-M 本身進行研究，以擴展其用途，擴展 Matrix-M 的智慧財產權，並且我們正在探索其在傳染病以外的應用。因此，我們的研究範圍不僅限於病毒抗原，還擴展到細菌抗原，正如您今天所提到的，謝謝您。此外，我們也希望超越傳染病領域，看看 Matrix-M 能做到什麼。

And so Ruxandra and her team are deep into the early exploration of some of those other avenues. And again, we're excited about the potential and excited to unveil in the coming quarters what we're learning there good. Jim, did you want to take the profitability question from Mayank?

因此，魯克桑德拉和她的團隊正在深入探索其他一些途徑。再次強調，我們對這方面的潛力感到興奮，並期待在接下來的幾季中公佈我們在這方面取得的進展。吉姆，你想從馬揚克接過獲利能力問題嗎？

Yes, certainly. Mayank, I think you and the investors have heard from us consistently that driving this company to non-GAAP profitability and beyond, throwing off cash as a company, delivering shareholder value, is a critical priority for the company, the timing of which, our goals to how we get there, you're watching us control what we can control, which is driving down our costs, seeking nondilutive funding along the way, making sure we have that strong balance sheet. But we also recognize we're, in many ways, reliant on our partners, Sanofi, in particular now, but heck, we're moving to bring more partners online as well.

當然可以。Mayank，我認為你和投資者一直都聽到我們說，推動公司實現非GAAP盈利甚至更高，為公司創造現金流，為股東創造價值，是公司的關鍵優先事項。至於實現這一目標的時機和方法，你正在看著我們控制我們能夠控制的因素，那就是降低成本，在此過程中尋求非稀釋性融資，並確保我們擁有強勁的資產負債表。但我們也意​​識到，在很多方面，我們依賴我們的合作夥伴，特別是現在的賽諾菲，但是，我們正在努力讓更多的合作夥伴上線。

New information since last we spoke, great news on CIC, two positive Phase I/II studies. But what we also learned, hey, Sanofi is going to be working with the regulators to get those programs advanced. This new information leads us to view the more likely time frame to potentially initiate a Phase III or get to market with CIC to have shifted out probably at least 6, 12 months just based on the timing of this update.

自上次我們談話以來，又有了新的消息，CIC方面傳來好消息，兩項I/II期研究結果均為正面。但我們也了解到，賽諾菲將與監管機構合作，推動這些計畫。根據此次更新的時間，這項新資訊使我們認為，啟動 III 期臨床試驗或將 CIC 產品推向市場的更可能時間框架可能至少推遲 6 到 12 個月。

Therefore, we updated the timing for the as-early-as estimate from 2027 to 2028. All said, though, when you look at all the pieces to what can drive us to profitability, we're seeing positive trends across the board. You heard our feedback on how we view the market.

因此，我們將最早實現時間的估計從 2027 年更新為 2028 年。不過總的來說，當我們審視所有可能推動我們獲利的因素時，我們看到各個方面都呈現出正面的趨勢。您已經聽到了我們對市場看法的回饋。

You heard from Rux and John how we view our technology, the advancement, and therefore our abilities to partner, including not just early-stage pipeline, but also our late-stage assets. And then you're hearing what I think is exceptional news, like I said, from Sanofi on their preparations for next year and beyond with COVID. So, we are certainly going to continue to endeavor and drive to this non-GAAP profitability and beyond. Just providing the latest update on that today.

您已經從 Rux 和 John 那裡聽到了我們對自身技術、發展以及合作能力的看法，這不僅包括早期研發管線，還包括後期資產。然後，正如我所說，你還會聽到賽諾菲關於他們為應對明年及以後的 COVID 疫情所做的準備工作，我認為這是非常了不起的消息。因此，我們一定會繼續努力，爭取實現非GAAP獲利，甚至超越這個目標。今天只是提供一下最新的進展。

Yes, Jim, and it's our intent to take a conservative position on that as we communicate with investors, toggle to what we know is in front of us as we learn related to the Sanofi deal itself. Just that one vehicle can lead to that with our base business that we already have, not including anything new we may do. So, right now, that's what we see in front of us based on that latest update, and we'll work really hard to do even better than that.

是的，吉姆，我們打算在與投資者溝通時採取保守立場，隨著我們對賽諾菲交易本身了解的深入，再根據我們目前掌握的情況調整策略。光是這輛車就能為我們現有的基礎業務帶來這樣的結果，還不包括我們可能開展的任何新業務。所以，根據最新的進展，這就是我們目前所看到的，我們會努力做得更好。

Super helpful. Appreciate the [transparency]. Thank you.

非常有用。感謝[透明度]。謝謝。

Eric Schmidt, Cantor.

埃里克·施密特，坎托爾。

Thanks, It's Eric filling in for Pete today. First, John and team, just congrats on the complete makeover of your company. You guys were way out ahead of the curve here and far larger companies in the space could certainly learn from your lead.

謝謝，今天由艾瑞克代替皮特值班。首先，約翰和他的團隊，祝賀你們公司完成了徹底的改造。你們在這方面遠遠領先於行業平均水平，該領域規模更大的公司肯定可以向你們學習。

Thank you, Eric.

謝謝你，埃里克。

It's been fun to watch. Question on Matrix-M and some of the MTAs you got exploring use of this with potential partners. What's the cadence of time lines and milestones, deliverables that a partner would need to go through in order to convert some of these evaluations to more formal arrangements. What time scale are you thinking about?

觀看比賽很有趣。關於 Matrix-M 的問題，以及您在與潛在合作夥伴探索其使用時獲得的一些 MTA。為了將其中一些評估轉化為更正式的安排，合作夥伴需要經歷怎樣的時間節點、里程碑和交付成果？你考慮的時間範圍是多久？

It's an excellent question, Eric. I'd love to be able to put a clock on that for you, but I cannot hear today. Obviously, there's more we know than we'd be able to say theoretically in any of those types of situations, right? The good news is that we have, to your point, multiple MTAs signed with organizations, a couple of large top 10 pharmaceutical global organizations that have an interest in this technology in this space, as well as a smaller company outside of infectious disease, even. So very, very interesting.

埃里克，你問得好。我很想幫你報個時間，但我今天聽不見。顯然，在任何這類情況下，我們所知道的比我們理論上能夠說的要多得多，對吧？好消息是，正如您所說，我們已經與多家機構簽署了材料轉移協議 (MTA)，其中包括幾家對這項技術在該領域感興趣的全球十大製藥公司，甚至還有一家規模較小的傳染病領域以外的公司。真是太有趣了。

That work is ongoing. Those companies, in general, I think the way to frame it in that type of arrangement, when you're working with a technology like we have, and this isn't Novavax specific, but I'll give you a framework to think about, company would take that type of technology, put it into the lab, do some experiments, they've done some thought experiment before that, obviously had communications with our team, business development team.

這項工作仍在進行中。總的來說，我認為在這種安排下，當你使用像我們這樣的技術時，應該這樣來建立關係。這並非特別指 Novavax，但我可以給你一個思考的框架：公司會採用這種技術，將其放入實驗室，進行一些實驗，他們之前也做過一些思想實驗，顯然也與我們的團隊、業務發展團隊進行過溝通。

We have data we share. We do experiments in our lab. They get interested. They duplicate those and do their own experiments in their lab. But these are not years. These are experiments that are shorter than that. They're in animal models in the lab. And if that's confirmatory, that would be the potential type of early pivot point in that journey where they might consider an arrangement with us. That's the type of framework to think about.

我們有可以共享的數據。我們在實驗室裡做實驗。他們產生了興趣。他們複製這些實驗結果，並在自己的實驗室進行自己的實驗。但這並非數年時間。這些實驗的時間比這還要短。它們存在於實驗室的動物模型中。如果這是確鑿的消息，那將是他們發展歷程中的潛在早期轉折點，他們可能會考慮與我們達成合作協議。這就是我們應該思考的框架類型。

So I won't put a clock to it, but I will say it's not years and years and years down the road. They'll know whether or not they'd like to do something with it as they get results out of their lab on early experiments. And then obviously, it takes a certain period of time, if we were to get to that point, to then negotiate deals. But our team has shown we're able to negotiate deals, whether it's selling real estate and downsizing certain areas that no longer support the new strategy, and thank you for recognizing how we've reshaped the company, or do something like a Sanofi arrangement and even these MTAs.

所以我不會給出確切的時間，但我可以說，這不會是很多很多年以後的事。隨著實驗室早期實驗結果的出爐，他們就會知道自己是否想用它做些什麼。然後很顯然，如果我們要走到那一步，就需要一段時間來談判達成協議。但我們的團隊已經證明我們有能力進行談判，無論是出售房地產，還是縮減不再支持新戰略的某些區域，感謝你們認可我們是如何重塑公司的，或者像與賽諾菲達成協議，甚至是這些MTA協議。

So, lots ahead is our intention. We're really excited about the potential, and there's a lot of interest in our technology outside of Novavax. So, we'll continue to work to mine that and hope in the near-term to have some updates for you that are exciting.

所以，我們未來還有很多目標要實現。我們對其潛力感到非常興奮，而且在 Novavax 之外，我們的技術也引起了許多人的興趣。所以，我們將繼續努力挖掘這些資源，並希望在不久的將來能為大家帶來一些令人興奮的更新。

Maybe another question on Nuvaxovid. Realizing that this is a transition year and that maybe traditional benchmarks like market share and sales don't really apply, are there things that would make this a successful transition year in terms of distribution channels and maybe softer metrics that you're looking for your partner to achieve? Thank you.

或許還可以問一個關於Nuvaxovid的問題。考慮到今年是過渡年，傳統的市場份額和銷售額等指標可能並不適用，那麼在分銷管道和一些更軟性的指標方面，有哪些因素能使今年成為成功的過渡年，而您希望您的合作夥伴能夠實現這些指標呢？謝謝。

Yes. I think a lot of that already happened, Eric, and I think Jim Kelly will comment as well here. But certainly, the transition from an EUA to a BLA to a full U.S. license was a critical first step, and that's a first for Novavax. So we handed the baton off on the EUA and picked it up for Sanofi on a BLA. And that happened mid-calendar year, and after initial retail negotiations begin. So you're halfway into the cycle.

是的。艾瑞克，我認為很多事情已經發生了，吉姆凱利也會對此發表評論。但可以肯定的是，從緊急使用授權 (EUA) 過渡到生物製品許可申請 (BLA) 再到獲得美國全面許可，這是一個至關重要的第一步，這對 Novavax 來說也是第一次。因此，我們交出了 EUA 的接力棒，並代表賽諾菲接過了 BLA 的接力棒。這件事發生在年中，也就是最初的零售談判開始之後。所以你已經完成了周期的一半。

But that was very important, though, that, that BLA was approved. Also prefilled syringe, also competitive shelf life approved at the same time as mRNAs by the regulatory authorities. It's an even playing field now. For the first time since I came here to Novavax, it's now an even playing field. And it had not been, as you know, through the pandemic and those things. But we've got it there, and it's in the hands of a world leader in vaccines on an even playing field. So we're very excited. Jim, anything to add to that?

但那非常重要的一點是，BLA 獲得了批准。此外，預充式註射器和具競爭力的保質期也與 mRNA 同時獲得監管機構的批准。現在雙方處於公平競爭的環境。自從我來到諾瓦瓦克斯以來，這是第一次出現公平競爭的情況。如你所知，疫情和其他一些事情發生後，情況並沒有改善。但我們已經掌握了它，而且它掌握在疫苗領域的全球領導者手中，雙方處於公平競爭的環境中。所以我們非常興奮。吉姆，你還有什麼要補充的嗎？

Well, John, really two things I'd add. So, while this year set the table with an even playing field, then what do you do with it? Well, we're seeing a couple of things. One is you got a full 12-month cycle time to get the contracting right.

約翰，我還有兩點要補充。所以，雖然今年為大家創造了公平的競爭環境，那接下來該怎麼做呢？嗯，我們看到了一些情況。一是你有整整 12 個月的周期時間來做好合約簽訂。

And what we know is Sanofi is an infinitely better contractor than we ever were with that full vaccine portfolio. So really looking forward to that piece of it. And then we also know, given the transition here, Sanofi is doing some piloting right across the country on different marketing techniques in submarkets. Excellent. That means their marketing capability toolkit is going to be optimized as they go into next year. And that's what we meant when we said, hey listen, we're really excited to have Sanofi as our commercial partner, and we're really happy at what the table has been set to enable them to do moving forward.

我們知道，就疫苗產品組合而言，賽諾菲比我們以往任何時候都更勝一籌。非常期待那一部分。此外，鑑於目前的情況，我們也知道賽諾菲正在全國各地針對不同細分市場開展不同行銷技術的試點計畫。出色的。這意味著他們的行銷能力工具包將在明年得到優化。這就是我們之前所說的，嘿，聽著，我們非常高興能與賽諾菲合作，成為我們的商業夥伴，我們也對目前為他們未來發展所做的一切感到非常滿意。

Appreciate the thoughts, guys. Thank you.

感謝各位的建議。謝謝。

Chris Lobianco, TD Securities.

Chris Lobianco，TD Securities。

Thank you for taking my questions. Congrats on all the progress this quarter. So, we've seen the competitors' Phase II shingles vaccine data, which showed comparable immunogenicity and better tolerability than Shingrix.

謝謝您回答我的問題。恭喜本季取得的所有進展。所以，我們已經看到了競爭對手的 II 期帶狀皰疹疫苗數據，數據顯示其免疫原性與 Shingrix 相當，但耐受性更好。

Can you remind us what Novavax thinks the clinical bar for success for a novel shingles vaccine is? And how might your vaccine platform be differentiated from some of the competitive data we've seen in Phase II?

您能否提醒我們一下，Novavax公司認為新型帶狀皰疹疫苗的臨床成功標準是什麼？那麼，你們的疫苗平台與我們在二期臨床試驗中看到的一些競爭對手的數據有何不同？

Ruxandra, were you able to hear the question from Chris?

魯克桑德拉，你聽到克里斯的問題了嗎？

I think that -- Chris, thank you for the question. I think that you have asked if we have looked at other competitors' data when it comes to the efficacy and tolerability of their shingles candidates. Is that so?

我認為——克里斯，謝謝你的提問。我想您是想問我們是否研究過其他競爭對手的帶狀皰疹候選藥物的療效和耐受性數據。是這樣嗎？

Yes, that's correct. And just how Novavax's platform might be differentiated.

是的，沒錯。Novavax 的平台究竟有何不同之處？

So, again, coming to the response that I gave at the previous question, we do actually have positive comparators and multiple comparators in all our preclinical testing using, obviously, for nonapproved vaccines. It is really based on the scientific endeavor and on the published data.

所以，再次回到我之前對問題的回答，我們所有的臨床前試驗中確實都有陽性對照和多個對照，顯然，這些試驗是針對未經批准的疫苗進行的。它確實是基於科學研究和已發表的數據。

This being said, in all the experiments, we are including groups that are treated either with shingles, yes, or with the type of vaccines that could mimic whatever is happening in other people's hands. So, we are very confident that the data that we are generating is actually very informative, and it's potentially going to compare well in human clinical trials. Obviously, we need to get there with our experiments, and we are actually looking forward to sharing with you more data when that is becoming available.

也就是說，在所有實驗中，我們都納入了接受帶狀皰疹治療的組別，或是接受能夠模擬其他人手上發生的情況的疫苗治療的組別。因此，我們非常有信心，我們產生的數據實際上非常有參考價值，並且有可能在人體臨床試驗中取得良好的效果。顯然，我們需要透過實驗才能達到目標，我們非常期待在獲得更多數據後與您分享。

Yes. It's a really good question, Chris, because -- and Rux, let me build upon what you just shared, and thank you for that, Rux. It's a good question. Obviously, the shingles vaccine, we've seen data that up to potentially 40% or so in certain markets of consumers may not get their booster shot on the current shingles vaccine because they're concerned about side effects. So, obviously, Chris, the bar on efficacy with the current marketed shingles vaccine is very high. That's an excellent vaccine when it comes to efficacy, and we're glad it's there to protect all of us as consumers.

是的。克里斯，你問的這個問題非常好，因為──還有魯克斯，讓我補充你剛才分享的內容，謝謝你，魯克斯。這是個好問題。顯然，關於帶狀皰疹疫苗，我們已經看到數據顯示，在某些市場，可能有多達 40% 左右的消費者不會接種目前的帶狀皰疹疫苗加強針，因為他們擔心副作用。所以很明顯，克里斯，目前市售帶狀皰疹疫苗的有效性要求非常高。就有效性而言，這是一款非常優秀的疫苗，我們很高興它能保護我們所有消費者。

The baggage on the side effects piece is an area for opportunity there for competitors to come in and improve. So, we're glad to see other companies are investing there. It's one of the top five or six areas of vaccine investment, actually, according to McKinsey and other sources because of this opportunity that's there.

副作用方面的不足之處，為競爭對手提供了一個可以改進的機會領域。所以，我們很高興看到其他公司也在那裡投資。事實上，根據麥肯錫和其他消息來源的說法，由於存在這樣的機會，疫苗投資領域排名前五或前六名。

Let me just say this, there's no guarantee, as you well know, in biotech -- this includes Novavax, right -- that anything coming out of your laboratories will go all the way to success. We're excited about early results we're seeing, but it's early. It's preclinical. Like Rux said, we have to go through all of the different studies and tests to get there, so do competitors.

我只想說，正如您所知，在生物技術領域——包括 Novavax 在內——並不能保證您實驗室研發的任何東西最終都會成功。我們對目前看到的初步結果感到興奮，但現在下結論還為時過早。這是臨床前研究階段。正如魯克斯所說，我們必須經歷各種不同的研究和測試才能達到目標，競爭對手也是如此。

So, it's good to see other programs advancing. How many of those may go all the way through full Phase III and meet that high efficacy bar that's out there or come close enough to it and deliver on the tolerability in the end in a final product, that's a difficult bar to achieve.

所以，很高興看到其他項目也在取得進展。其中有多少藥物能夠順利完成整個 III 期臨床試驗，達到目前所設定的高效標準，或足夠接近高效標準，並在最終產品中實現良好的耐受性，這是一個很難達到的標準。

We'll be glad -- we'll bet on our technology every time because we believe in Matrix-M and what we're doing, and we believe that we've got a strong shot to have a competitive product. Again, we're not promising on anything, future deals, things coming out of the clinic. There's risk in biotech. You have to execute. It's our intention to do so. We've got a great technology platform we're confident in, and we're excited to bring it forward.

我們很樂意——我們每次都會押注我們的技術，因為我們相信 Matrix-M 和我們正在做的事情，我們相信我們有很大的機會推出一款有競爭力的產品。再次聲明，我們不對任何事情做出承諾，包括未來的交易和診所即將推出的產品。生物技術領域存在風險。你必須執行。我們打算這樣做。我們擁有一個強大的技術平台，我們對此充滿信心，並很高興能將其推向市場。

Great, thank you.

太好了，謝謝。

Alec Stranahan, Bank of America.

亞歷克·斯特拉納漢，美國銀行。

Hey guys, thanks for taking my questions. Congrats on the continued progress in the quarter. First, good to see the second $25 million milestone come in a few days ago. So, we've got that for 4Q. Looking to next year, appreciate the preliminary guidance for '26.

各位好，感謝你們回答我的問題。恭喜本季取得持續進展。首先，很高興看到幾天前第二個 2500 萬美元的里程碑達成。所以，這就是我們第四季的情況。展望明年，感謝 2026 年的初步指導。

Could you maybe walk us through the $75 million milestone estimate? I guess, what does this entail? And assuming this is fairly high conviction given the preliminary guidance, any other high conviction items that you maybe single out beyond the Sanofi milestones next year? And then I've got a follow-up.

您能否為我們解釋一下7500萬美元里程碑的估算情況？我想，這具體包含哪些內容呢？假設根據初步指引，這一結論相當有把握，那麼除了賽諾菲明年的里程碑之外，您認為還有其他哪些事項需要重點關注？然後我還有一個後續問題。

All right, Alec, thank you for your question. And you're certainly right. We're very pleased with the progress we've made to date across both pipeline advancement and also supporting our partners. In particular, as we look at the milestones for next year, the $75 million milestone that we've included in the 2026 adjusted revenue framework relates to completion of manufacturing tech transfer with Sanofi.

好的，亞歷克，謝謝你的提問。你說的完全正確。我們對迄今為止在管道推進和支援合作夥伴方面取得的進展感到非常滿意。特別是，當我們展望明年的里程碑時，我們在 2026 年調整後的收入框架中納入的 7,500 萬美元里程碑與完成與賽諾菲的製造技術轉移有關。

So, specifically, what that means is we knew when we signed our CLA with Sanofi that we'd be supporting them with commercial manufacturing while they learned what it would take to be self-sufficient to manufacture on their own.

所以具體來說，這意味著我們在與賽諾菲簽署CLA協議時就知道，我們將為他們提供商業生產的支持，同時幫助他們學習如何自給自足地進行生產。

And we believe we're right on track to be able to complete that manufacturing tech transfer by the fourth quarter next year. So, what that's going to mean for our financial statements is not just the milestone hits, but that 2026 will be the completion of when we act as a bit of a middleman on getting supply for Sanofi for them to market.

我們相信，我們完全有能力在明年第四季完成這項製造技術轉移。所以，這對我們的財務報表來說，不僅意味著里程碑的達成，還意味著 2026 年我們將完成為賽諾菲提供產品供應，使其進入市場的過渡期。

And as you know, Serum Institute is who we've been working with for multiple years to do so. So that's the transition period, that's the milestone, and the conviction to complete it really just comes from the methodical work we've been doing to date with a great partner.

如您所知，我們多年來一直與印度血清研究所合作進行這項工作。所以，這就是過渡期，這就是里程碑，而完成它的信念，實際上來自於我們迄今為止與一位優秀的合作夥伴所做的有條不紊的工作。

And then maybe just a quick follow-up, Jim, on the supply sales piece. Is it right to assume this is essentially just reimbursement for the COGS on Nuvaxovid production as you manage through the transition of manufacturing? And I guess, is it for the most part, on-time production? Or do you still maybe manufacture some number of doses at risk? Thank you.

吉姆，關於物資銷售那部分，或許可以再快速跟進。是否可以這樣假設，這本質上只是在生產過渡期間對 Nuvaxovid 生產成本的補償？我想，大部分情況下，生產都能準時完成嗎？或者你們仍然冒險生產一定數量的疫苗？謝謝。

All right. Excellent. So, our supply sales, so that's a new component this year to our product sales, has two primary pieces. One is COVID vaccine that we provide for Sanofi for them to sell. So, that's part one. And next year, that's anticipated to be the final year we do that because we would have completed the tech transfer I described.

好的。出色的。所以，我們的供應銷售（這是我們今年產品銷售的一個新組成部分）主要包括兩個部分。其中之一是我們提供給賽諾菲公司銷售的新冠疫苗。好了，第一部分就到這裡。預計明年將是我們進行這項活動的最後一年，因為我們將完成我所描述的技術轉移。

Under our agreement with Sanofi, the intent is to have just a little bit of margin on top of our cost there. So, think of it more as a just over breakeven proposition. Then when you look at the other component of supply sales, well, it's Matrix-M, and it's Matrix-M to all of our partners.And that's going to be a more durable stream of revenue, but with the same concept.

根據我們與賽諾菲的協議，我們的目的是在成本之上只保留一點利潤。所以，不妨把它看作是一個略高於損益平衡點的項目。然後，當你審視供應銷售的另一個組成部分時，你會發現，它是 Matrix-M，我們所有的合作夥伴都使用 Matrix-M 產品。這將是一個更穩定的收入來源，但理念相同。

The intent that -- and listen, we're really just trying to support our partners. There's a small margin there. And what you're witnessing with that part, and this is the Matrix supply sales in particular, is that as our partner unit volumes grow, and the example I'll give you here that is really going great in volume is R21 malaria vaccine.

我們的意圖是——而且聽著，我們真的只是想支持我們的伴侶。優勢很小。而你現在看到的，特別是矩陣供應銷售方面的情況是，隨著我們合作夥伴的單位銷售增長，我在這裡舉個例子，銷量確實非常可觀的是 R21 瘧疾疫苗。

And you heard that since launch last year, approximately 25 million doses. Well, what that's doing is that's driving us to a critical mass, economies of scale for our Matrix manufacturing. And so what it does is it allows us to be efficient, to be right there for our partners.

你也聽說了，自去年推出以來，大約已經接種了 2500 萬劑。這樣做會促使我們達到臨界規模，實現 Matrix 製造的規模經濟。因此，它使我們能夠提高效率，隨時為我們的合作夥伴提供支援。

You also asked a question about just in time. So, the way this works, the cycle time, and I'll speak just to the COVID right now, is that manufacturing effort really begins in the first quarter, when you're working through the different variants, you do PPQs and you do a lot of that DS production early in the season. The more or closer to just in time is the DP fills. And you do this so you can maximize shelf life. And those really begin to occur over the summer leading into the season. So that's the cycle time. That's how production works.

您還問了一個關於準時生產的問題。所以，它的運作方式，週期時間，我現在只談談新冠疫情，是製造工作實際上從第一季開始，那時你要處理不同的變體，你要做PPQ，你要在季初做很多DS生產。DP填充越及時越好。這樣做是為了最大限度地延長保質期。這些情況通常會在夏季賽季開始前逐漸出現。這就是周期時間。生產就是這樣進行的。

Great, thank you.

太好了，謝謝。

Tom Shrader, BTIG.

湯姆·施拉德，BTIG。

Good morning. Thanks for the details. Quick one on the Sanofi pandemic effort. Is there any guidance on the size the government stockpile would be? And would that be meaningful to you? Is there one royalty for Sanofi? Or because this is a different type arrangement, is that a very different royalty back to you? And then I have a COVID follow-up.

早安.謝謝你提供的詳細資訊。簡單介紹一下賽諾菲在疫情​​期間的努力。政府儲備規模方面是否有任何指導意見？那對你來說有意義嗎？賽諾菲有統一的專利使用費嗎？或者，因為這是不同的合作方式，所以你獲得的版稅也完全不同？然後我還要做一次新冠後續檢查。

Yes. Very good question, Tom. No, we don't have guidance on what the government may be targeting from a stockpiling perspective. I know there's some historical precedent there that you and our investor base could reference if needed.

是的。湯姆，問得好。不，我們沒有關於政府從儲備角度來看可能針對哪些目標的指導。我知道這方面有一些歷史先例，如果需要的話，您和我們的投資者可以參考這些先例。

But what we can say is it wasn't part of the original agreement on our partnership with Sanofi to include our Matrix-M in the pandemic flu because we were working on our own as well. We did agree -- we worked with Sanofi to expand our agreement to now include the ability for them to use our Matrix-M with their flu vaccine.

但我們可以肯定的是，將我們的 Matrix-M 納入流感大流行治療方案並不在我們與賽諾菲最初的合作協議之內，因為我們當時也在進行自己的研究。我們達成了一致——我們與賽諾菲合作，擴大了我們的協議範圍，現在包括允許他們將我們的 Matrix-M 與他們的流感疫苗一起使用。

And look, frankly, it's good for business, and even more importantly, it's good for global public health to have options there if that were to hit. So, we think it's our responsibility, and it's also a very good strengthening of our partnership and could provide a very lucrative opportunity should something like that hit.

坦白說，這對企業有好處，更重要的是，如果這種情況發生，有許多選擇對全球公共衛生也有好處。所以，我們認為這是我們的責任，也是加強我們合作關係的一個很好的方式，如果發生類似的事情，還能帶來非常有利可圖的機會。

Now that being said, what we've left open and what we said on the last earnings call is should Sanofi move forward and bring that forward and reach a certain point with it, there's a point where we would then negotiate the terms in good faith with them around how the economics would work around that.

話雖如此，我們之前在上次財報電話會議上說過，如果賽諾菲繼續推進該項目並達到一定階段，那麼我們將與他們本著誠意就相關經濟條款進行談判。

So, let's hope for global public health's sake that, that opportunity is not there for these vaccine companies, including us. If it does come, we intend to stand ready, hopefully, with -- through partnering our own assets, should we achieve a partnership there with our own flu, and secondarily through Sanofi, of course. So we'll keep you posted.

所以，為了全球公共衛生，讓我們祈禱，包括我們在內的這些疫苗公司不會有這樣的機會。如果真的發生了，我們打算做好準備，希望能夠透過與我們自己的流感疫苗合作，利用我們自己的資產，其次當然是透過賽諾菲。我們會隨時向您報告最新情況。

And then a raging piece of the COVID world is the duration of protection of the mRNA vaccines. People are bashing this number all over the place. And you could be a lot better. And the question is, is that -- do you see that as a place you might do more clinical work to show your duration is really better? There are hints of it. But is that something you think you might do? And conversely, do you think it's something that might be thrust upon you? I know it's forward-looking, but thank you.

而新冠疫情領域一個備受關注的問題是mRNA疫苗的保護期。到處都有人抨擊這個數字。你還可以做得更好。問題是，你是否認為在那裡你可以進行更多臨床工作，以證明你的持續時間確實更好？有一些跡象表明確實如此。但你覺得你會做這件事嗎？反過來，你認為這是有可能強加在你身上的事情嗎？我知道這是前瞻性的，但還是要謝謝你。

No, very good question. We'll hand that over to Ruxandra. Rux?

不，問得好。我們會把這件事交給魯克桑德拉。魯克斯？

Yes. That's a very good question. So, there are some ongoing real-world evidence studies that are undertaken. Obviously, these are studies that last a little bit longer than just one season that are looking exactly at that, at the durability of protection.

是的。這是一個很好的問題。因此，目前正在進行一些現實世界的證據研究。顯然，這些研究的持續時間比一個賽季要長一些，它們正是著眼於防護的持久性。

And as the data is coming in, us and partners, we are sure that, that type of data is going to be published. As that entails large populational studies, they are typically undertaken by third parties, academic investigators, research institutes, your Centers for Disease Control because they do impact large swathes of the population. So, to make a long story short, that type of studies are ongoing, and we hope to see the results soon.

隨著數據的不斷湧入，我們和合作夥伴確信，這類數據將會被公佈。由於這涉及大規模的人口研究，因此通常由第三方、學術研究人員、研究機構、疾病管制中心等進行，因為它們確實會影響到很大一部分人口。簡而言之，這類研究正在進行中，我們希望很快能看到結果。

Geoff Meacham, Citi.

傑夫‧米查姆，花旗銀行。

This is Mary Kate Davis on for Geoff this morning. Thanks for taking the questions. We'd love to talk through a little bit more of the strategy behind your early-stage pipeline and the impact here. And thank you for giving great detail so far this morning. It's super helpful.

這裡是瑪麗凱特戴維斯，今天早上為您報道傑夫。謝謝您回答問題。我們很樂意更深入地探討您早期研發管線背後的策略及其對這裡的影響。非常感謝您今天上午提供的如此詳盡的資訊。非常有用。

You walked us through the progress towards IND and would love to dial in on the opportunities for early data updates and what they could look like. And then as a follow-up, just given the public health burden of these diseases, how are you looking at the opportunity of these chosen targets? And would you consider partnerships in this space as you move these programs forward? Thank you.

您向我們詳細介紹了 IND 的進展情況，我們很想深入了解早期數據更新的機會以及它們可能的形式。那麼，作為後續問題，考慮到這些疾病對公共衛生造成的負擔，您如何看待這些選定目標的機會？在推進這些專案的過程中，您是否會考慮與該領域的合作夥伴建立聯繫？謝謝。

Thank you for the questions, and I'll let Rux dive in here in just a moment. We took a lot of time as a leadership team. As you know, we're in transition with our company, and we're in really chapter 2 of that transition, having moved away from a fully-integrated commercial organization to an organization that has a great technology platform, is looking to out-license that, to partner that, and to generate additional opportunities to do that via our pipeline R&D innovation.

謝謝大家的提問，我馬上就請Rux來回答這個問題。作為領導團隊，我們花了很多時間。如您所知，我們公司正處於轉型期，我們實際上已經進入轉型的第二階段，從一家完全一體化的商業組織轉型為一家擁有強大技術平台的組織，並尋求對外授權、建立合作夥伴關係，並透過我們的研發創新管道創造更多機會來實現這一目標。

That's very important. We see it -- we see our technology platform and our efforts through Ruxandra and her team in R&D as an engine that could generate additional and future ongoing opportunities to further partner our tech, to further expand it into new areas even beyond infectious disease.

這非常重要。我們看到了這一點——我們看到我們的技術平台以及 Ruxandra 和她的研發團隊所做的努力，可以成為一個引擎，為進一步合作開發我們的技術，並將其擴展到傳染病以外的新領域，從而創造更多未來持續的機會。

So, you make a good point by saying, would you consider partnering those assets out of your pipeline. It's actually our intention to do so. And what we have said in the past is that we retain the right, the ability to decide for ourselves, and we'll do that through continued economic stability, strengthening our P&L, strengthening our cash runway, and our financial framework for the company, which will be ongoing through this transition.

所以，你提出的問題很有道理，那就是，你會考慮將你產品線中的這些資產與合作夥伴合作嗎？事實上，這正是我們的計劃。我們過去曾說過，我們保留著自主決策的權利和能力，我們將透過持續的經濟穩定、增強損益表、增強現金儲備以及完善公司財務框架來實現這一目標，而這些都將在過渡期間持續進行。

We continue to do so to be able to have the choice if we do get a home run coming out of the pipeline, and we want to keep that ourselves, we'll consider that. But our model now is based on partnering with other pharmaceutical companies, keeping a lean and focused infrastructure, leveraging our technology and our assets to generate those revenues and those partnerships, and then the engine in R&D and innovation to create even new future opportunities, part 1.

我們繼續這樣做是為了能夠做出選擇：如果我們真的從人才儲備中獲得了一個非常好的結果，而我們又想把這個結果保留下來，我們會考慮的。但我們現在的模式是與其它製藥公司合作，保持精簡和專注的基礎設施，利用我們的技術和資產來創造這些收入和合作關係，然後透過研發和創新來創造更多新的未來機會，第一部分。

Part 2, you asked about our strategy behind the pipeline. Obviously, we looked at where the most significant unmet need lies around the globe, where our technology, we believe, could have the best chance to help address those unmet needs and generate with good odds, in our opinion, competitive assets coming out of those efforts.

第二部分，您問了我們管道背後的策略。顯然，我們考察了全球範圍內最迫切的未滿足需求所在，我們認為，我們的技術最有機會幫助解決這些未滿足的需求，並且我們認為，很有可能從這些努力中產生具有競爭力的資產。

Obviously, like any biotech company, there's never a guarantee that anything or everything you do out of your pipeline will succeed. But you deal with probabilities of success. So we put a lot of time into placing the bets where we feel we have the best chance to win, the best odds to see one or more or multiple assets coming out in the future that could succeed.

顯然，和任何生技公司一樣，你研發的任何產品或所有產品都無法保證一定會成功。但你面對的是成功的機率。因此，我們投入大量時間進行投注，認為我們最有機會獲勝，賠率最高，能夠看到未來一個或多個資產取得成功。

We stage-gate those things. This is typical for an organized, efficient, and professional biotech company to have stage-gate markers where you have go/no-go decisions based on outcomes each step of the way. Our entire philosophy on this is lean, intelligent investment to keep derisking one step at a time, and each step as we continue to succeed, we continue to approach the target product profile that we believe will be competitive, constantly assessing the competitive landscape to see if that needs to change. We got some questions from Chris and others on that today, very good questions. We're thinking about that as a team. We're paying close attention.

我們對這些東西進行階段性把關。對於一家組織有序、高效專業的生物技術公司來說，設立階段性里程碑是很常見的，這樣就可以根據每個階段的結果做出是否繼續的決定。我們在這方面的理念是精益、明智的投資，一步一步地降低風險，隨著我們不斷取得成功，我們不斷接近我們認為具有競爭力的目標產品概況，並不斷評估競爭格局，看看是否需要做出改變。今天我們收到了克里斯和其他人的一些提問，都是非常好的問題。我們團隊正在考慮這個問題。我們正在密切關注。

We're very careful with any dollar we put down on that bet. And we'll be willing to walk away at any time from an asset that's not delivering. We don't have pet projects here. We're running a business. And we also want to have, secondarily to that but very important to our employees and to us, our mission, to impact global public health in a positive way. Hopefully, that addresses your question.

我們對投入那筆賭注中的每一美元都非常謹慎。如果某項資產無法帶來收益，我們隨時都願意放棄它。我們這裡沒有個人項目。我們在經營一家企業。其次，雖然這對我們的員工和我們來說非常重要，但我們也希望實現我們的使命，以積極的方式影響全球公共衛生。希望這能解答你的疑問。

Xun Lee, H.C. Wainwright.

李迅，H.C. Wainwright。

Hi guys, thanks for taking the questions. I just have a higher level one on the longer-term projections that you guys had. Looking at the 2027 expense numbers, we see that the expenses are expected to come down by almost 50% compared to this year's levels. So, I was wondering if you can provide some color on which areas you feel that you can cut the most from? And what -- maybe what other areas you feel deserves additional investments. Thanks.

大家好，感謝你們回答問題。我只是對你們的長期預測有一個更高層次的理解。從 2027 年的支出數據來看，預計支出將比今年的水準下降近 50%。所以，我想問您能否具體說明一下，您認為哪些方面的支出可以削減最多？那麼—您認為還有哪些領域值得追加投資？謝謝。

Xun, appreciate the question. The primary step-downs in changes to our cost structure as we look at 2026 and 2027 are the following. 2026, what you're seeing is that many of the transition activities that we're doing with Sanofi, actually virtually all of them, are completed in 2026.

荀，感謝你的提問。展望2026年及2027年，我們成本結構調整的主要步驟如下。 2026年，您可以看到，我們與賽諾菲開展的許多過渡活動，實際上幾乎所有活動，都將在2026年完成。

So, you're seeing that as we support Sanofi's both commercialization through the form of manufacturing support, strain change, and continue to support their clinical efforts, completion of certain R&D and clinical study activities, those are hitting our financials, and our team is working on them through 2026.

因此，您可以看到，隨著我們透過生產支援、菌株變更等形式支持賽諾菲的商業化，並繼續支持他們的臨床工作、完成某些研發和臨床研究活動，這些都對我們的財務狀況產生了影響，我們的團隊正在努力解決這些問題，直到 2026 年。

But they're becoming smaller year-over-year, '25 versus '26. As we move into 2027, and these are virtually complete, you're seeing the next step-down in activity. And so, it's that $250 million net, which is our target, because you never know, maybe one of our partners might come back and say, do you mind doing some incremental work for us? We'd say, certainly, just cover our cost. So it's that net number, which is our core spend target. It is that number that we're driving towards, and we think we have excellent line of sight to get there.

但與 2025 年相比，它們的規模正在逐年縮小，2026 年的規模就更小了。隨著我們進入 2027 年，這些項目基本上完成，你會看到活動量開始下降。所以，我們的目標淨收入是 2.5 億美元，因為你永遠不知道，也許我們的某個合作夥伴會回來問，你們是否介意為我們做一些額外的工作？當然，我們只會收回成本。所以，這個淨額就是我們的核心支出目標。我們正朝著這個目標努力，我們認為我們有很好的前景來實現這個目標。

Okay, good. Thanks a lot.

好的。多謝。

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

今天的問答環節到此結束。我謹將會議交還給約翰·雅各布斯，請他作總結發言。

Thank you, everyone, for joining us today. We appreciate it. Look forward to speaking with you next time.

謝謝各位今天蒞臨。我們很感激。期待下次與您交談。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議已經結束。感謝各位參加今天的報告會。您現在可以斷開連線了。