Novavax Inc (NVAX) 2025 Q2 法說會逐字稿

內容摘要

  1. 摘要
    • Q2 2025 營收為 2.39 億美元,較去年同期 4.15 億美元下滑,主要包含來自 Sanofi 的 1.75 億美元里程碑金;本季淨利 1.07 億美元,每股盈餘 0.62 美元。
    • 上修 2025 年全年營收指引至 10~10.5 億美元,反映 Matrix M 需求提升與合作夥伴里程碑金增加,並更新 R&D/SG&A 費用預估至 4.95~5.45 億美元(含 FDA 要求的 post-marketing study)。
    • 市場反應未於逐字稿中揭露。
  2. 成長動能 & 風險
    • 成長動能:
      • 與 Sanofi 的合作深化,BLA 獲批帶來 1.75 億美元里程碑金,未來還有美歐授權與技術轉移相關里程碑金與權利金收入。
      • Takeda 日本市場合作條件優化,Nuvaxavir 預計秋季呼吸道季節前上市,進一步擴大市場滲透。
      • R21 Matrix M 瘧疾疫苗於 12 個非洲國家推廣,2025 年已售出 1,400 萬劑,遠超去年全年 600 萬劑,顯示需求強勁。
      • Matrix M 載體平台持續獲得外部藥廠關注,已簽署 3 份 MTA,並展開新適應症(如腫瘤)合作討論,有望帶來未來權利金收入。
      • 新一代流感與 COVID-19 組合疫苗(KIC)及單獨流感疫苗臨床數據正面,T 細胞免疫反應優於 Fluzone High Dose,具差異化潛力。
    • 風險:
      • 營收高度依賴合作夥伴(Sanofi、Takeda、Serum Institute)推進與市場表現,若合作進度或銷售不如預期,將影響獲利時程。
      • FDA 要求的 post-marketing study 帶來額外成本,雖大部分由 Sanofi 負擔,但仍需執行並確保數據正面。
      • 流感與 COVID 疫苗市場競爭激烈,未來產品上市與市佔率仍具不確定性。
  3. 核心 KPI / 事業群
    • Q2 營收:2.39 億美元,較去年同期 4.15 億美元下滑,主因為里程碑金認列時點差異
    • R21 Matrix M 瘧疾疫苗:2025 年已售出 1,400 萬劑,遠超 2024 年全年 600 萬劑
    • Q2 產品銷售:1,100 萬美元(含 1,300 萬美元供應銷售,-200 萬美元 Nuvaxavid 產品銷售因美國市場結束及退貨準備)
    • Q2 授權/權利金及其他收入:2.29 億美元(Sanofi 1.99 億、Takeda 2,700 萬)
    • Q2 R&D + SG&A 費用:1.23 億美元,年減 41%;SG&A 年減 57%
  4. 財務預測
    • 2025 年營收預估上修至 10~10.5 億美元(不含 Sanofi 供應銷售、權利金、組合疫苗及 Matrix M 相關里程碑金)
    • 2025 年 R&D + SG&A 費用預估 4.95~5.45 億美元(含 post-marketing study)
    • 2026/2027 年 R&D + SG&A 費用(扣除合作夥伴補助後)分別為 3.5 億/2.5 億美元
  5. 法人 Q&A
    • Q: 2025/2026 COVID 疫苗供應進度與申請狀況?今年秋季能否如期供貨?
      A: 已取得 BLA 核准,今秋將供應 JM1 疫苗,並同步申請延長保存期限以提升競爭力。
    • Q: KIC 與流感疫苗合作進展、潛在合作夥伴興趣與時程?
      A: 正與多家潛在合作夥伴洽談,Sanofi 對組合疫苗前景持正面看法,具體合作時程未能透露。*管理層未具體回答
    • Q: Matrix M MTA(材料轉讓協議)如何轉化為財務交易?BARDA 對新平台的態度?
      A: MTA 讓潛在夥伴自行驗證技術,若有需求將進一步洽談授權或合作;BARDA 對多平台持開放態度,正持續爭取政府資助。
    • Q: 是否考慮併購或引進外部臨床階段產品?
      A: 目前聚焦於現有合作與自有管線開發,優先推動內部創新與平台價值釋放,暫無併購計畫。
    • Q: FDA post-marketing study(PMC)設計、規模與時程?
      A: 預計 2025 年底啟動,總成本 7,000~9,000 萬美元,Sanofi 承擔約 70%,將針對特定年齡族群與明確終點進行。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good morning, and welcome to Novavax second-quarter 2025 financial results and operational highlights conference call. (Operator Instructions) Please note this event is being recorded.

    早安,歡迎參加 Novavax 2025 年第二季財務業績與營運亮點電話會議。(操作員指示)請注意,此事件正在被記錄。

  • I would now like to turn the conference over to Luis Sanay, Vice President, Investor Relations. Please go ahead.

    現在,我想將會議交給投資人關係副總裁 Luis Sanay。請繼續。

  • Louis Sinead - Vice President, Investor Relations

    Louis Sinead - Vice President, Investor Relations

  • Good morning, and thank you all for joining us today to discuss our second 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,感謝大家今天加入我們,討論我們 2025 年第二季的財務表現和營運亮點。宣布我們研究結果的新聞稿可在我們的網站 novavax.com 上查閱,本次電話會議的音訊存檔將於今天稍後在我們的網站上提供。

  • Please turn to slide 2. Before we begin with prepared remarks, I need to remind you that this presentation includes forward-looking statements, including, 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, its expectations regarding manufacturing capacity, timing, production and delivery for its COVID-19 vaccine, the development of Novavax's clinical and pre-clinical product candidates, the timing and results of our clinical trials, including the Nuvaxovid post-marketing commitment study, full year 2025 financial guidance and revenue framework and Novavax's future financial or business performance.

    請翻到投影片 2。在我們開始準備好的演講之前,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、其策略重點、其合作夥伴關係以及對潛在特許權使用費、里程碑和成本補償的期望、對其 COVID-19 疫苗的製造能力、時間、生產和交付的期望、Novavax 臨床開發結果的時間、生產和臨床開發結果(Novavax 臨床開發結果和臨床開發年全年財務指導和收入框架以及 Novavax 未來的財務或業務績效有關的陳述。

  • Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause our 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我們的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的“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 10-K 表和後續 10-Q 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-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.

    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。本簡報也包括對非公認會計準則財務指標的引用,即調整後總收入、調整後的授權、特許權使用費和其他收入、合併研發和銷售、一般及行政費用減去合作夥伴報銷和非公認會計準則獲利能力。

  • 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 Jim Kelly, Chief Financial Officer and Treasurer, will review our financial results and 2025 financial guidance and revenue framework. Silvia Taylor, Chief Corporate Affairs and Advocacy Officer, will be available for the Q&A portion of the call.

    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;財務長兼財務主管 Jim Kelly 將審查我們的財務表現和 2025 年財務指導和收入架構。首席公司事務及宣傳長 Silvia Taylor 將出席此電話會議的問答環節。

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

    我現在想把電話交給約翰。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Thank you, Luis. I'm excited to be here today with members of our executive team to share our second quarter results and the meaningful progress that we've made. Q2 was a strong quarter as we continue to execute on our strategy to expand access to our proven technology platform by advancing R&D innovation and organically growing our portfolio, strengthening existing partnerships while working actively to forge new collaborations.

    謝謝你,路易斯。我很高興今天能與我們的執行團隊成員在這裡分享我們的第二季業績和我們取得的有意義的進展。第二季度表現強勁,我們繼續執行我們的策略,透過推進研發創新和有機成長我們的產品組合,加強現有的合作夥伴關係,同時積極建立新的合作夥伴關係,以擴大對我們成熟技術平台的訪問。

  • This focused approach is designed to unlock multiple paths to value creation and supports our outlook for potential non-GAAP profitability as early as 2027. During Q2, we remained focused on our three strategic priorities for the year. And now I'd like to take a few moments to highlight our progress on each of them during the quarter.

    這種專注的方法旨在開闢創造價值的多種途徑,並支持我們最早在 2027 年實現潛在非 GAAP 盈利的前景。在第二季度,我們仍然專注於今年的三大戰略重點。現在我想花點時間來介紹一下我們本季在每個方面取得的進展。

  • Our first strategic priority is optimizing our partnership with Sanofi. During the quarter, we received BLA approval for Nuvaxovid in the US, which triggered a $175 million milestone payment to Novavax to be received in the third quarter. We also completed the transition of commercial activities to Sanofi in the US. This means that for the '25, '26 season, Sanofi is now poised to assume the lead commercialization role for Nuvaxovid in select global markets.

    我們的首要策略重點是優化與賽諾菲的合作關係。本季度,我們在美國獲得了 Nuvaxovid 的 BLA 批准,這觸發了向 Novavax 支付 1.75 億美元的里程碑付款,該付款將於第三季度收到。我們也完成了向美國賽諾菲的商業活動轉移。這意味著,在 25、26 賽季,賽諾菲已準備好在全球特定市場中擔任 Nuvaxovid 的主導商業化角色。

  • The Sanofi partnership represents a significant value creation opportunity for Novavax via the multifaceted nature of the agreement, including milestones and royalties associated with the commercialization of our COVID vaccine. As noted, we earned the $175 million milestone for the BLA.

    與賽諾菲的合作為 Novavax 帶來了重大的價值創造機會,該協議具有多面性,包括與我們的 COVID 疫苗商業化相關的里程碑和特許權使用費。如上所述,我們為 BLA 贏得了 1.75 億美元的里程碑。

  • And in addition, we are on track for milestone payments associated with the transfer of the US and EU marketing authorizations and the technology transfer related to Nuvaxovid manufacturing, which are anticipated later this year and in late 2026, respectively.

    此外,我們正在按計劃支付與美國和歐盟行銷授權轉移以及與 Nuvaxovid 製造相關的技術轉移相關的里程碑付款,預計將分別於今年稍後和 2026 年底支付。

  • Beyond the economics related to Nuvaxovid, Novavax is eligible to receive milestones and royalties associated with the development of new combination vaccines that include our COVID vaccine. As a reminder, Sanofi is developing two combination vaccine candidates, which include our COVID vaccine and their market-leading flu vaccines, both of which received fast track designation from the FDA last year.

    除了與 Nuvaxovid 相關的經濟利益外,Novavax 還有資格獲得與包括我們的 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。提醒一下,賽諾菲正在開發兩種聯合候選疫苗,其中包括我們的 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。

  • We're encouraged by Sanofi's recent comments on the potential of COVID flu combo vaccines. And Sanofi has access to develop vaccines with our proven and unique Matrix-M adjuvant for which Novavax is eligible to earn milestones and royalties. Together, we are excited that this partnership has the potential to increase access to our technology and drive long-term value.

    賽諾菲最近對 COVID 流感組合疫苗潛力的評論令我們感到鼓舞。賽諾菲可以使用我們經過驗證的獨特 Matrix-M 佐劑開發疫苗,而 Novavax 有資格獲得里程碑和特許權使用費。我們非常高興,此次合作有潛力擴大我們技術的使用範圍,並推動長期價值。

  • Our second strategic priority is to enhance our existing partnerships and leverage our technology platform and pipeline to drive additional partnerships. Novavax's cutting-edge tech platform, consisting of our protein-based nanoparticles and our one-of-a-kind Matrix-M adjuvant has the potential to drive the development of both new and improved vaccines that are efficacious and tolerable.

    我們的第二個策略重點是加強現有的合作夥伴關係,並利用我們的技術平台和管道來推動更多的合作關係。Novavax 的尖端技術平台由我們以蛋白質為基礎的奈米顆粒和獨一無二的 Matrix-M 佐劑組成,有可能推動有效且耐受的新型和改良疫苗的開發。

  • This value creating technology platform has been validated through current marketed products, Nuvaxovid and the R21 Matrix-M malaria vaccine, our growing clinical dataset and our current partnerships.

    該價值創造技術平台已透過目前銷售的產品 Nuvaxovid 和 R21 Matrix-M 瘧疾疫苗、我們不斷增長的臨床數據集和我們目前的合作夥伴關係得到驗證。

  • Let's talk about those current partnerships. This quarter, we optimized our partnership with Takeda for the Japanese market through an updated collaboration and exclusive license agreement, which significantly improved the financial terms for Novavax and improved the partnership's operating model.

    讓我們來談談當前的合作關係。本季度,我們透過更新的合作和獨家授權協議優化了與武田在日本市場的合作夥伴關係,這顯著改善了 Novavax 的財務條款並改善了合​​作夥伴關係的營運模式。

  • With its advanced infrastructure and strong regulatory environment, Japan is the third largest global health care market, and we believe our continued partnership will help to meet the needs of the COVID market in Japan. Takeda filed for approval of Nuvaxovid in June and is on track to have approval and doses in market in time for the fall respiratory season.

    日本憑藉其先進的基礎設施和強大的監管環境,成為全球第三大醫療保健市場,我們相信,我們持續的合作將有助於滿足日本 COVID 市場的需求。武田於 6 月提交了 Nuvaxovid 的批准申請,預計將在秋季呼吸道疾病高發季節之前獲得批准並上市。

  • Additionally, through our partnership with Serum Institute of India and Oxford University, the R21 Matrix-M malaria vaccine has made meaningful progress in addressing the urgent and unmet needs of malaria endemic regions, since its first administration in Ivory Coast in June of 2024.

    此外,透過與印度血清研究所和牛津大學的合作,R21 Matrix-M 瘧疾疫苗自 2024 年 6 月在科特迪瓦首次使用以來,在解決瘧疾流行地區的緊急和未滿足的需求方面取得了有意義的進展。

  • The R21 Matrix-M vaccine is helping to expand access to life-saving prevention in communities with limited health care infrastructure with rollouts in 12 African countries as of April 2025. In fact, over 20 million doses have been sold to-date since launch in mid '24. Malaria historically has killed over 600,000 people annually, with the vast majority of deaths occurring in children under five in sub-Saharan Africa.

    截至 2025 年 4 月,R21 Matrix-M 疫苗已在 12 個非洲國家推出,協助擴大醫療基礎設施有限的社區獲得救命預防的機會。事實上,自 2024 年中期推出以來,已售出超過 2,000 萬劑。歷史上,瘧疾每年導致超過 60 萬人死亡,其中絕大多數死亡發生在撒哈拉以南非洲的五歲以下兒童。

  • R21 Matrix-M has the first low-cost, high-efficacy malaria vaccine produced at scale represents not only a clinical global public health tool, but also a strategic opportunity in a market where demand significantly exceeds current supply. We are pleased that our active and successful commercial collaborations with Sanofi and Takeda and our public health partnership with Serum and Oxford have positioned us as a partner of choice in the vaccine space.

    R21 Matrix-M 是第一個大規模生產的低成本、高效瘧疾疫苗,不僅代表著一種臨床全球公共衛生工具,也是需求遠遠超過目前供應的市場中的策略機會。我們很高興與賽諾菲和武田開展了積極且成功的商業合作,並與 Serum 和 Oxford 建立了公共衛生夥伴關係,這使我們成為疫苗領域的首選合作夥伴。

  • With this strong momentum, we're actively pursuing new partnerships that could help to further accelerate the positive global health impact of our technology and unlock additional value for both shareholders and the communities we serve.

    憑藉這一強勁勢頭,我們正在積極尋求新的合作夥伴關係,以幫助進一步加速我們的技術對全球健康的積極影響,並為股東和我們服務的社區釋放更多價值。

  • We believe that our technology platform can play an important role in driving innovation in the global vaccine market that is expected to grow to over $75 billion by 2030. This quarter, we continued to advance strategic opportunities for our Matrix-M adjuvant.

    我們相信,我們的技術平台可以在推動全球疫苗市場的創新方面發揮重要作用,預計到 2030 年該市場的規模將增長到 750 億美元以上。本季度,我們持續推進 Matrix-M 佐劑的策略性機會。

  • Our unique Matrix-M adjuvant is well positioned to drive innovation via our own organic portfolio and partnering with potential to generate meaningful future royalty streams for Novavax for years to come.

    我們獨特的 Matrix-M 佐劑具有良好的優勢,可以透過我們自己的有機產品組合推動創新,並與潛在合作夥伴合作,在未來幾年為 Novavax 創造有意義的未來特許權使用費流。

  • To-date, we've signed material transfer agreements with three pharmaceutical companies to explore the utility of Matrix-M across novel indications, including its potential application in oncology. These arrangements have led to discussions about potential business partnerships to develop new vaccines and improve existing vaccines.

    迄今為止,我們已經與三家製藥公司簽署了材料轉移協議,以探索 Matrix-M 在新型適應症中的效用,包括其在腫瘤學中的潛在應用。這些安排引發了有關開發新疫苗和改進現有疫苗的潛在商業夥伴關係的討論。

  • In parallel, we continue to explore the potential for government grants to support the development of our pandemic influenza vaccine candidate, reinforcing our commitment to platform diversification and long-term value creation.

    同時,我們繼續探索獲得政府補助的可能性,以支持我們大流行性流感疫苗候選物的開發,加強我們對平台多樣化和長期價值創造的承諾。

  • In June, we reported positive data from an initial Phase 3 cohort showing our COVID-19 Influenza-Combination, or CIC, and standalone flu vaccine candidates elicited strong immune responses, similar to licensed comparators in Nuvaxovid and Fluzone high-dose with over 98% of adverse events rated mild or moderate.

    6 月,我們報告了初始 3 期隊列的積極數據,顯示我們的 COVID-19 流感組合(CIC)和獨立流感候選疫苗引發了強烈的免疫反應,類似於 Nuvaxovid 和 Fluzone 高劑量的許可對照藥,超過 98% 的不良事件被評為輕度或中度。

  • These results are important and helpful as we continue to engage in discussions with potential partners for these late-stage assets. Ruxandra will share additional insights and new data from this program in a few moments.

    當我們繼續與潛在合作夥伴討論這些後期資產時,這些結果非常重要且有幫助。稍後,Ruxandra 將分享該計劃的更多見解和新數據。

  • And finally, our third strategic priority is to advance our technology platform and early-stage pipeline. We're advancing a focused pipeline of vaccine candidates targeting unmet needs in infectious disease, and we are exploring the utility of Matrix-M in oncology. Using a capital-efficient model grounded in strong science and sharply focused on future commercial potential, we're also applying AI-driven insights to accelerate candidate development.

    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產品線。我們正在推進針對傳染病未滿足需求的候選疫苗重點研發線,並且正在探索 Matrix-M 在腫瘤學中的實用性。我們使用以強大科學為基礎、高度關注未來商業潛力的資本高效模型,同時應用人工智慧驅動的洞察力來加速候選人的發展。

  • At the same time, we're sharpening our strategy to enhance the attractiveness of our technology, particularly Matrix-M to potential partners. This includes exploring new formulations and additional ideas to unlock its full value.

    同時,我們正在完善策略,以增強我們的技術(尤其是 Matrix-M)對潛在合作夥伴的吸引力。這包括探索新的配方和額外的想法以釋放其全部價值。

  • As we have noted before, our primary focus is to out-license and or partner vaccine assets we are developing in our pipeline. But if we discover a significant opportunity via those R&D efforts, we may decide to bring that asset forward on our own, if the value proposition indicates it is best to keep that asset with Novavax.

    正如我們之前所指出的,我們的主要重點是對外授權和/或合作我們正在開發的疫苗資產。但是,如果我們透過這些研發工作發現了一個重大機遇,我們可能會決定自行推進該資產,如果價值主張表明最好將該資產保留在 Novavax。

  • As you can see, this quarter, we continued to progress our growth strategy across all of its core elements, delivering on our existing partnerships, furthering discussions with potential future partners and advancing our pipeline.

    如您所見,本季度,我們繼續推動所有核心要素的成長策略,鞏固現有合作夥伴關係,進一步與未來潛在合作夥伴進行討論,並推進我們的產品線。

  • Later in the call, Jim will highlight the progress we've made in driving greater operational efficiency as we transition to a more lean and agile business model. Taken together, the progress we're making is well aligned with our corporate growth strategy and continues to strengthen our foundation, fueling the potential for long-term value creation and positioning us to deliver meaningful impact on a global scale, potentially improving the lives of billions.

    在電話會議的後期,吉姆將重點介紹我們在向更精實、更敏捷的業務模式轉型過程中在提高營運效率方面所取得的進展。總的來說,我們所取得的進展與我們的企業成長策略高度一致,並將繼續加強我們的基礎,激發長期價值創造的潛力,並使我們能夠在全球範圍內產生有意義的影響,從而有可能改善數十億人的生活。

  • I'd now like to turn the call to Ruxandra to discuss our R&D updates. Ruxandra?

    現在我想把電話轉給 Ruxandra,討論我們的研發更新。魯克珊德拉?

  • Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

    Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

  • Thank you, John. Please turn to slide 7. Since the last earnings update, we progressed our programs, and I'm excited to share several important developments, starting with new insights from our CIC and standalone flu program, followed by promising new data from our H5N1 program. We've also made strong progress across our pre-clinical pipeline, including our RSV combination, C. difficile and VZV programs.

    謝謝你,約翰。請翻到幻燈片 7。自上次收益更新以來,我們推進了我們的計劃,我很高興與大家分享幾個重要的進展,首先是來自我們的 CIC 和獨立流感計劃的新見解,然後是來自我們的 H5N1 計劃的有希望的新數據。我們也在臨床前研發管線中取得了長足進展,包括呼吸道合胞病毒 (RSV) 組合、艱難梭菌 (C. difficile) 和水痘帶狀皰疹病毒 (VZV) 計畫。

  • Please turn to slide 8. I'll start with our late-stage CIC and standalone flu program. In June, we announced results of the initial cohort of our CIC and standalone flu trial, where both vaccine candidates induced robust neutralizing antibody responses that were similar to licensed comparators.

    請翻到第 8 張投影片。我將從我們的後期 CIC 和獨立流感計劃開始。6 月,我們公佈了 CIC 和獨立流感試驗的初始隊列結果,其中兩種候選疫苗均誘導了強大的中和抗體反應,與獲得許可的比較劑相似。

  • In vaccine development for diseases like influenza and COVID, we look for differentiated attributes such as breadth of protection against drifted strains and the durability of response, a vaccine that can provide protection for a longer period of time could have a significant impact.

    在針對流感和 COVID 等疾病的疫苗開發中,我們尋找差異化屬性,例如對漂移株的保護廣度和反應的持久性,能夠提供更長時間保護的疫苗可能會產生重大影響。

  • During the quarter, we generated new data, including additional analysis of T-cell responses, which showed that in both the standalone flu and CIC arms, increases from baseline in influenza-specific polyfunctional expressing CD4 positive T-cells were numerically higher than in the comparator Fluzone high-dose arm.

    在本季度,我們產生了新的數據,包括對 T 細胞反應的額外分析,結果表明,在獨立的流感和 CIC 組中,流感特異性多功能表達 CD4 陽性 T 細胞相對於基線的增加在數值上高於對照 Fluzone 高劑量組。

  • This is notable as T-cells recognize conserve influenza epitopes, which are associated with broader and longer-lasting immune responses. T-cells also play a key role in viral clearance and contribute to durability of protection. In addition, T-cells COVID-specific responses were similar between CIC and Nuvaxovid arms.

    值得注意的是,T 細胞識別保守的流感表位,而這些表位與更廣泛、更持久的免疫反應有關。T 細胞在病毒清除過程中也發揮關鍵作用,並有助於持久保護。此外,CIC 和 Nuvaxovid 組之間的 T 細胞 COVID 特異性反應相似。

  • While this immunogenicity and safety trial was not a pivotal trial, the data can inform a future registrational Phase 3 program. We intend to partner both candidates to conduct registrational trials. And as John already mentioned, partnering discussions are underway.

    雖然這次免疫原性和安全性試驗並不是一項關鍵試驗,但其數據可以為未來的註冊 3 期計畫提供參考。我們打算與兩位候選人合作進行註冊試驗。正如約翰已經提到的,合作討論正在進行中。

  • Please turn to slide 9. In July, we published new pre-clinical data in Nature Communications, demonstrating that our H5N1 avian influenza vaccine candidate built on our recombinant protein-based platform and Matrix-M adjuvant generated robust immune responses after a single or two-dose intranasal or intramuscular administration in prime non-human primates.

    請翻到第 9 張投影片。7 月,我們在《自然通訊》上發表了新的臨床前數據,證明我們基於重組蛋白平台和 Matrix-M 佐劑的 H5N1 禽流感候選疫苗在原代非人類靈長類動物中通過單劑量或兩劑量鼻腔內或肌肉注射後產生了強大的免疫反應。

  • This indicates that we may be able to offer flexible options for consumers. For example, intranasal administration could lower viral loads and potentially result in decreased transmission. In addition, unlike vaccines, which might require two or more doses for full protection, the possibility to administer a single vaccine dose is important in the context of a pandemic. These findings reinforce once again the strength of our technology platform and highlight the potential of our pandemic influenza program.

    這表明我們可能能夠為消費者提供靈活的選擇。例如,鼻內給藥可以降低病毒量並可能減少傳播。此外,與可能需要兩劑或更多劑才能完全保護的疫苗不同,在大流行的背景下,接種單劑疫苗的可能性非常重要。這些發現再次增強了我們的技術平台的實力,並凸顯了我們的大流行性流感計畫的潛力。

  • Please turn to slide 10. On the pre-clinical side, our RSV combination C. difficile and VZV zoster programs have continued their rapid journey towards development of compelling, differentiated and commercially attractive next-generation vaccines.

    請翻到第 10 張投影片。在臨床前方面,我們的呼吸道合胞病毒 (RSV) 艱難梭菌和水痘-帶狀皰疹病毒 (VZV) 組合疫苗計畫繼續快速推進,致力於開發引人注目、差異化且具有商業吸引力的下一代疫苗。

  • These assessments are executed in carefully thought out in silico, in-vitro and animal models that will address dosing regimens and criteria for our predefined target product profiles. Our goal is to rapidly position the programs for the clinic.

    這些評估是在經過深思熟慮的電腦模擬、體外和動物模型中執行的,這些模型將解決我們預先定義的目標產品概況的給藥方案和標準。我們的目標是快速定位診所的專案。

  • For the C. difficile program, we are initiating and prioritizing animal models to delineate key biology questions on humoral and mucosal immunity and focusing on translational questions. We have incorporated new proteins into our antigens in addition to the main toxins to enhance differentiation, efficacy and cross-variant protection.

    對於艱難梭菌項目,我們正在啟動並優先考慮動物模型來描述體液和黏膜免疫的關鍵生物學問題,並專注於轉化問題。除了主要毒素外,我們還在抗原中加入了新的蛋白質,以增強分化、功效和交叉變異保護。

  • One of the main challenges for C. difficile is that vaccines are not cross-protecting against various bacterial ribotypes. Protection against C. difficile and its complication remains a large unmet medical need with no C. diff vaccine available today.

    艱難梭菌面臨的主要挑戰之一是疫苗不能對各種細菌核醣體型產生交叉保護作用。由於目前尚無艱難梭菌疫苗,預防艱難梭菌及其併發症仍是一個巨大的未滿足的醫療需求。

  • For the RSV combination, we are incorporating important lessons learned from our first-generation RSV clinical program and our CIC program into a second-generation antigen design. Our technology platform facilitates combination vaccines development, and this matters as consumers have indicated a preference for combination vaccines.

    對於 RSV 組合,我們將從第一代 RSV 臨床計劃和 CIC 計劃中獲得的重要經驗教訓融入第二代抗原設計中。我們的技術平台促進了聯合疫苗的開發,這一點很重要,因為消費者已經表示出對聯合疫苗的偏好。

  • For shingles prevention, we continue to generate key differentiation data in pre-clinical models with the goal of showing similar efficacy with existing vaccines while demonstrating lower reactogenicity. This comes from the observation that at-risk adults are declining shingles protection or don't complete their vaccination series due to fear of adverse effects.

    對於帶狀皰疹預防,我們繼續在臨床前模型中產生關鍵的分化數據,目的是顯示與現有疫苗相似的功效,同時證明較低的反應原性。這是根據觀察得出的結論:高風險成年人由於害怕不良反應,正在拒絕帶狀皰疹防護或不完成疫苗接種。

  • Finally, early data shows initial promise in use of Matrix beyond conventional vaccines, opening new avenues of research in highly compelling disease use cases. For example, this quarter, we generated preliminary positive data using Matrix-M with an oncology vaccine candidate with potential future applications across several tumor types.

    最後,早期數據顯示,Matrix 在傳統疫苗以外的應用具有初步前景,為極具吸引力的疾病使用案例的研究開闢了新的途徑。例如,本季度,我們使用 Matrix-M 與腫瘤疫苗候選物產生了初步的正面數據,該疫苗未來可能應用於多種腫瘤類型。

  • As a means to advance our pre-clinical programs, we also continue to innovate with our technology. We have strategically added to our translational medicine and adjuvant teams to ensure we have the right technological capabilities to continue to build out our next generation of R&D using our existing pre-clinical programs as a test bed.

    作為推進臨床前計畫的一種手段,我們也不斷創新我們的技術。我們策略性地擴充了我們的轉化醫學和輔助團隊,以確保我們擁有合適的技術能力,以現有的臨床前專案為試驗平台,繼續建立我們的下一代研發。

  • There will be more to share in the coming months, but two main highlights are: number one, use of generative AI methods to inform antigen construct design, tethered with expanded high throughput cloning and second, the use of AI/ML approaches to rapidly and cost effectively create and test antibodies, including assessing antigen epitope integrity of neoantigens. This data gives us unprecedented insights into the behavior of antigen and adjuvant drug substance, which helps prepare for clinical positioning.

    未來幾個月將會有更多內容分享,但主要有兩個亮點:第一,使用生成式人工智慧方法來指導抗原構建體設計,並與擴展的高通量克隆相結合;第二,使用人工智慧/機器學習方法快速且經濟高效地創建和測試抗體,包括評估新抗原的抗原表位完整性。這些數據讓我們對抗原和輔助藥物的行為有了前所未有的了解,有助於為臨床定位做好準備。

  • Looking ahead, we are excited to host our Investor Day in the coming quarters where I will go into greater detail on the programs I've discussed today. As we advance our early-stage pipeline, we intend to take a strategic and fiscally disciplined approach, prioritizing programs that address significant unmet medical needs and offer compelling commercial potential.

    展望未來,我們很高興在接下來的幾季舉辦投資者日,屆時我將更詳細地介紹我今天討論的計劃。隨著我們早期研發管線的推進,我們打算採取策略性和財政嚴謹的方法,優先考慮那些能夠滿足重大未滿足醫療需求並提供巨大商業潛力的專案。

  • I'll now turn the call to Jim.

    我現在將電話轉給吉姆。

  • James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

    James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

  • Thank you, Ruxandra. Please turn to slide 11. This morning, we announced our financial results for the second 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.

    謝謝你,魯克桑德拉。請翻到第 11 張投影片。今天上午,我們公佈了2025年第二季的財務表現。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-Q 表中找到。

  • Please turn to slide 12. I'll begin with key highlights from our second quarter 2025 financial results. Novavax reported total revenue of $239 million as compared to $415 million in the second quarter of 2024. Total revenue included $175 million milestone earned from Sanofi related to the May 2025 FDA approval of our Nuvaxovid BLA in the US. We expect cash receipt of the $175 million milestone in the third quarter of 2025.

    請翻到第 12 張投影片。我將從我們 2025 年第二季財務業績的重點開始。Novavax 報告總收入為 2.39 億美元,而 2024 年第二季為 4.15 億美元。總收入包括賽諾菲為我們在美國的 Nuvaxovid BLA 於 2025 年 5 月獲得 FDA 批准而獲得的 1.75 億美元里程碑收入。我們預計在 2025 年第三季將收到 1.75 億美元的里程碑現金。

  • During the second quarter of 2025, we continue to transform Novavax into a more lean and agile organization. Evidence this quarter includes the 41% reduction in our combined R&D and SG&A costs compared to the same period last year.

    2025 年第二季度,我們將繼續推動 Novavax 轉型為一個更精簡、敏捷的組織。本季的證據包括,與去年同期相比,我們的研發和銷售、一般及行政費用總額減少了 41%。

  • And of note, we reduced SG&A by 57% as we transferred lead commercial activities to Sanofi and reduced infrastructure. Looking forward, we are updating our full year 2025 revenue framework and financial guidance to reflect the impact of the recently announced FDA post-marketing commitment study.

    值得注意的是,由於我們將主要商業活動轉移到賽諾菲並減少基礎設施,我們將銷售、一般及行政費用減少了 57%。展望未來,我們正在更新 2025 年全年收入框架和財務指導,以反映最近宣布的 FDA 上市後承諾研究的影響。

  • Importantly, we do not anticipate the cost of the study to have an impact on our 2025 and 2026 operating profit profile as Sanofi reimbursement is expected to cover the incremental study costs added to our plan. We ended the second quarter with over $850 million in cash and receivables, including the $175 million milestone payment from Sanofi.

    重要的是,我們預計研究成本不會對我們 2025 年和 2026 年的營業利潤狀況產生影響,因為賽諾菲的報銷預計可以涵蓋我們計劃中增加的增量研究成本。截至第二季末,我們擁有超過 8.5 億美元的現金和應收帳款,其中包括賽諾菲支付的 1.75 億美元里程碑付款。

  • In addition, we anticipate earning an additional [$50 million] in milestones from Sanofi in the fourth quarter of 2025 upon the transfer of marketing authorization for the US and Europe. Our goal is to drive financial performance by reaching and growing non-GAAP profitability and maintaining at least 1.5 years to 2 years of cash on hand at all times. Depending on the near-term performance of our partners, we see the potential to achieve this profitability mark as early as 2027.

    此外,我們預計在 2025 年第四季轉移美國和歐洲的營銷授權後,將從賽諾菲獲得額外的 [5000 萬美元] 里程碑收入。我們的目標是透過達到和提高非公認會計準則獲利能力並始終保持至少 1.5 年至 2 年的現金儲備來推動財務績效。根據我們合作夥伴的近期表現,我們認為最早在 2027 年就有可能實現這項獲利目標。

  • Please turn to slide 13 for a detailed review of our second quarter revenue results and disclosures. For the second quarter of 2025, we recorded total revenue of $239 million compared to $415 million in the same period in 2024. Product sales for the second quarter of 2025 of $11 million consisted of $13 million from supply sales and negative $2 million of Nuvaxovid product sales from the closeout of our US market activities and related return reserves.

    請翻到第 13 張投影片來詳細了解我們第二季的收入結果和揭露情況。2025 年第二季度,我們的總營收為 2.39 億美元,而 2024 年同期為 4.15 億美元。2025 年第二季的產品銷售額為 1,100 萬美元,其中包括供應銷售額 1,300 萬美元,以及來自我們美國市場活動結束和相關退貨儲備的 Nuvaxovid 產品銷售額負 200 萬美元。

  • Our second quarter supply sales were primarily from adjuvant sales to our license partners. We are encouraged by the increased demand for Matrix-M as this enables the company to better reach manufacturing economies of scale and aids the improvement of our margins.

    我們第二季的供應銷售主要來自向我們的授權合作夥伴的佐劑銷售。Matrix-M 需求的成長令我們感到鼓舞,因為這使公司能夠更好地實現製造規模經濟並有助於提高我們的利潤率。

  • Of note, year-to-date sales of the R21 Matrix and malaria vaccine of 14 million doses already exceeds the 6 million doses sold for the full year 2024 and highlights the steady progress being made by our partner, the Serum Institute with the launch. We recorded $229 million of licensing, royalties and other revenue in the second quarter, consisting of $199 million and $27 million related to our Sanofi and Takeda agreements, respectively.

    值得注意的是,今年迄今為止,R21 Matrix 和瘧疾疫苗的銷量已達 1,400 萬劑,超過了 2024 年全年 600 萬劑的銷量,這凸顯了我們的合作夥伴血清研究所在疫苗推出方面取得的穩步進展。我們在第二季度記錄了 2.29 億美元的許可、特許權使用費和其他收入,其中與賽諾菲和武田協議相關的收入分別為 1.99 億美元和 2,700 萬美元。

  • Please turn to slide 14 for a detailed view of our second quarter financial results, where I'll focus on our operating expense results and trends. Second quarter 2025 combined R&D and SG&A expenses were $123 million and reflect a 41% and $85 million reduction from the same period in 2024.

    請翻到第 14 張投影片來詳細了解我們的第二季財務業績,我將重點介紹我們的營運費用結果和趨勢。2025 年第二季研發銷售、一般及行政費用合計為 1.23 億美元,較 2024 年同期減少 41% 及 8,500 萬美元。

  • Importantly, our SG&A expenses were 57% lower than the same period last year and are driven by the transition of the lead global commercial activities to Sanofi plus strong execution of our broader cost reduction plan.

    重要的是,我們的銷售、一般及行政費用比去年同期降低了 57%,這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。

  • Research and development expenses of $79 million in the second quarter of 2025 were primarily driven by our investment in the CIC-flu study and support of Sanofi for the upcoming COVID-19 vaccine season. A smaller portion of this spend is presently directed towards our early-stage pre-clinical programs. And finally, we reported net income of $107 million or $0.62 per diluted share for the second quarter of 2025.

    2025 年第二季的研發費用為 7,900 萬美元,主要來自我們對 CIC-flu 研究的投資以及對賽諾菲對即將到來的 COVID-19 疫苗季節的支持。目前,這筆支出的一小部分用於我們早期的臨床前計畫。最後,我們報告 2025 年第二季的淨收入為 1.07 億美元,即每股 0.62 美元。

  • Please turn to slide 15. In May 2025, Nuvaxovid received US market authorization and with that approval came an FDA request to complete a post-marketing commitment study or PMC. Today, we are sharing the specifics around the execution of this study and its impact on Novavax's revenue framework and financial guidance.

    請翻到第 15 張投影片。2025 年 5 月,Nuvaxovid 獲得美國市場授權,FDA 隨即要求其完成上市後承諾研究或 PMC。今天,我們將分享這項研究的執行細節及其對 Novavax 收入框架和財務指導的影響。

  • Importantly, we are sharing that this update is not anticipated to have an impact on our 2025 and 2026 operating profit profile as Sanofi reimbursement is expected to cover the incremental study costs added to our plans. The PMC study is anticipated to occur during 2025 and 2026 with a total cost of between $70 million and $90 million.

    重要的是,我們要分享的是,此次更新預計不會對我們 2025 年和 2026 年的營業利潤狀況產生影響,因為賽諾菲的報銷預計將涵蓋我們計劃中增加的增量研究成本。PMC 研究預計將於 2025 年至 2026 年期間進行,總成本在 7,000 萬美元至 9,000 萬美元之間。

  • Novavax will conduct this study on behalf of Sanofi, and Novavax will be reimbursed 70% of total cost or approximately $55 million midpoint of that range. In the table below, we outlined both the specific updates we are making to our revenue framework and financial guidance and introduce a new metric where we show our combined R&D and SG&A expenses less partner reimbursements.

    Novavax 將代表賽諾菲進行這項研究,並將獲得總費用的 70% 或該範圍中點約 5500 萬美元的補償。在下表中,我們概述了對收入框架和財務指導所做的具體更新,並引入了一個新指標,其中顯示了我們的綜合研發費用和銷售、一般及行政費用減去合作夥伴報銷金額。

  • This new non-GAAP metric reinforces that we are on track with our previously communicated expense targets through 2027 when adjusting for partner reimbursements.

    這項新的非公認會計準則指標進一步證明,在調整合作夥伴報銷金額後,我們將能夠實現先前公佈的到 2027 年的支出目標。

  • Please turn to slide 16. We are committed to streamlining our operations to enable value creation. Our updated full year 2025 financial guidance for combined R&D and SG&A expenses is now $495 million to $545 million to include the addition of the PMC study.

    請翻到第 16 張投影片。我們致力於簡化營運以創造價值。我們更新後的 2025 年全年研發和銷售、一般及行政費用合併財務指引現為 4.95 億美元至 5.45 億美元(包括增加的 PMC 研究)。

  • We are also sharing our multiyear targets highlighting our expectations 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. The resulting lean and agile operating model is focused on targeted investments in R&D to drive value creation.

    我們也分享了我們的多年目標,強調了我們對 2026 年和 2027 年研發和銷售、一般及行政費用總額的預期,扣除合作夥伴報銷後分別為 3.5 億美元和 2.5 億美元。我們相信,提供總支出和合作夥伴報銷淨額的觀點可以讓投資者更了解我們的核心營運成本結構。由此產生的精實和敏捷營運模式專注於針對性地投資研發以推動價值創造。

  • Please turn to slide 17. 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 $1 billion and $1.050 billion. Our 2025 revenue framework excludes Sanofi supply sales, royalties, influenza COVID combination and Matrix-M related milestones.

    請翻到第 17 張投影片。現在轉向我們的 2025 年收入架構。今天,我們提高了先前的收入框架,目前預計調整後的總收入將達到 10 億美元至 10.5 億美元之間。我們的 2025 年收入架構不包括賽諾菲供應銷售額、特許權使用費、流感 COVID 組合和 Matrix-M 相關里程碑。

  • This means there may be revenue in 2025 that is additive to our expectations for adjusted total revenue for the year. At midpoint, the $25 million increase to our 2025 adjusted total revenue is driven by a $5 million increase to adjusted supply sales related to increased demand for Matrix-M from Serum for the R21 Matrix-M malaria vaccine, and a $20 million increase to adjusted licensing royalties and other revenue that has three components and includes a $20 million increase to Sanofi cost reimbursement related to the PMC study, a $10 million increase to other partner revenue from Takeda based on milestones and royalties under that agreement and a $10 million decrease to amortization related to the Sanofi upfront payment and pediatric milestone that we now expect to recognize in 2026.

    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。中點計算,2025 年調整後總收入增加 2,500 萬美元,是由於 Serum 公司對 R21 Matrix-M 瘧疾疫苗的 Matrix-M 需求增加,導致調整後供應銷售額增加 500 萬美元,以及調整後許可使用費和其他收入增加 2000 萬美元,該收入包含三個部分,包括與諾菲諾菲萬美元、基於該協議下的里程碑和特許權使用費,來自武田的其他合作夥伴收入增加 1000 萬美元,以及與賽諾菲預付款和兒科里程碑相關的攤銷減少 1000 萬美元,我們現在預計將在 2026 年確認這些里程碑。

  • Our year-to-date 2025 sales of $906 million leaves $119 million to be recognized in the second half of 2025 at the midpoint of our revenue framework for adjusted total revenue. We expect the majority of this remaining amount to occur in the fourth quarter. We look forward to sharing additional updates as we improve Novavax's financial performance, cost structure and strength to deliver shareholder value.

    我們 2025 年年初至今的銷售額為 9.06 億美元,預計在 2025 年下半年確認的調整後總收入框架中位數為 1.19 億美元。我們預計剩餘金額的大部分將在第四季度到位。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。

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

    說完這些,我想把電話轉回給約翰,讓他做一些結束語。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Thank you, Jim. In summary, we intend to drive long-term value creation through our corporate growth strategy and continue to focus on our three strategic priorities.

    謝謝你,吉姆。總而言之,我們打算透過企業成長策略推動長期價值創造,並持續專注於我們的三大策略重點。

  • First, executing on our Sanofi partnership and in doing so, successfully demonstrating we are a partner of choice. Second, enhancing existing partnerships and leveraging our technology platform and pipeline to forge additional collaborations. And third, advancing our technology platform and early-stage pipeline.

    首先,我們與賽諾菲建立合作關係,並在此過程中成功證明我們是首選合作夥伴。第二,加強現有的合作關係,並利用我們的技術平台和管道建立更多的合作。第三,推動我們的技術平台和早期研發管線。

  • Thank you all for joining us today and a sincere thank you to our employees for their unwavering dedication to advancing our mission. I'm proud of what we've accomplished, and I'm energized by the opportunities ahead as we execute on our strategy to drive meaningful value.

    感謝大家今天的到來,並真誠感謝我們的員工為推進我們的使命所做的不懈奉獻。我為我們所取得的成就感到自豪,並且在我們執行推動有意義價值的策略的過程中,我對未來的機會感到充滿活力。

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

    現在我想將電話轉給我們的接線生進行問答。操作員?

  • Operator

    Operator

  • (Operator Instructions) Roger Song, Jefferies.

    (操作員指示)Roger Song,Jefferies。

  • Roger Song - Equity Analyst

    Roger Song - Equity Analyst

  • Great. Congrats for all the progress, and thanks for the update and taking our questions. Two from us. One is in terms of the 2025, 2026 COVID season supply, given you will continue to use [JN.1], would you still file for approval for this season for your vaccine? And then when the supply will be ready for the season?

    偉大的。恭喜您取得的所有進展,並感謝您的更新和回答我們的問題。我們有兩個。一是就 2025 年、2026 年 COVID 季節的供應而言,鑑於您將繼續使用 [JN.1],您還會為本季的疫苗申請批准嗎?那麼什麼時候才能為這個季節準備好供應呢?

  • And then also second question related to the CIC and flu partnership discussion. Any additional comments regarding the interest level, the progress? And then how should we think about the timeline you will be able to sign a partner to move forward into the pivotal? Thank you.

    第二個問題與 CIC 和流感夥伴關係討論有關。關於興趣程度和進展還有其他評論嗎?那麼,我們應該如何考慮與合作夥伴簽約並邁向關鍵階段的時間表呢?謝謝。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Jim, do you want to take Roger's first question?

    吉姆,你想回答羅傑的第一個問題嗎?

  • James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

    James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

  • Certainly. Good morning, Roger. With respect to the regulatory filings for readiness for our COVID vaccine for the fall season, you're right that we had a BLA approval for JN.1, which is our intent to deliver that vaccine JN.1 this fall. We also, however, in parallel, are working to improve the shelf-life profile of our vaccine for this fall to a more competitive profile, the expectation being six months, at least.

    當然。早安,羅傑。關於我們秋季 COVID 疫苗準備的監管備案文件,您說得對,我們已經獲得了 JN.1 的 BLA 批准,我們打算在今年秋天推出該疫苗 JN.1。然而,同時,我們也在努力改善今年秋季疫苗的保質期,使其更具競爭力,預計至少六個月。

  • And therefore, the regulatory filings we're doing right now for readiness for the fall are really focused on that improvement in shelf-life profile and stability. And then I believe your next question related to the combination vaccine potential partnering. Can you just restate one more time?

    因此,我們目前為秋季做好準備而進行的監管備案實際上側重於保質期和穩定性的改善。然後我相信您的下一個問題與聯合疫苗潛在合作有關。你能再說一次嗎?

  • Roger Song - Equity Analyst

    Roger Song - Equity Analyst

  • Yeah, sure. So just any comments around the interest level, the progress of the discussion? And then what's the timeline we should looking at or expecting for the partnership to move forward?

    是的,當然。那麼,您對興趣程度和討論進度有何評論?那麼,我們應該關注或期待合作關係向前發展的時間表是怎樣的呢?

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Good question, Roger. Obviously, due to the nature of those types of conversations, we can't give detail or comment on that. But what we did allude to is that we are in conversation with multiple potential partners. And as things develop and we can share, we will. I will say that there's been strong commentary we've been pleased with from our partner, Sanofi.

    問得好,羅傑。顯然,由於此類對話的性質,我們無法提供詳細資訊或對此發表評論。但我們確實提到,我們正在與多個潛在合作夥伴進行對話。隨著事態的發展,我們可以分享,我們就會這麼做。我想說的是,我們的合作夥伴賽諾菲給了我們正面的評價,我們對此感到非常高興。

  • So if you take a look at their statements in their recent earnings discussions, they speak very positively about the potential of combination assets in COVID flu moving forward in the future. Both of the assets they're developing with our Nuvaxovid received fast track designation from FDA, and we're very excited about the potential of that future. Rux, did you want to add anything else on Roger's question regarding CIC-flu combination?

    因此,如果你看一下他們在最近的收益討論中的聲明,你會發現他們對未來 COVID 流感中組合資產的潛力持非常樂觀的態度。他們與我們的 Nuvaxovid 共同開發的兩項資產都獲得了 FDA 的快速通道認證,我們對其未來的潛力感到非常興奮。Rux,關於 Roger 提出的 CIC-flu 組合的問題,你還有什麼要補充的嗎?

  • Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

    Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

  • So the only thing that I would like to add is, as you might remember, this was the first cohort from the trial where we were assessing the immunogenicity and obviously adding to the safety database. The data that we have generated was to actually strengthen the body of data that we already had, and it was not a registrational trial. The registrational trial would be undertaken by that potential partner when that partnership would occur.

    因此,我唯一想補充的是,您可能還記得,這是試驗中的第一批患者,我們正在評估其免疫原性,顯然要將其添加到安全資料庫中。我們產生的數據實際上是為了加強我們已經擁有的資料主體,而且這不是註冊試驗。當合作關係建立時,潛在合作夥伴將進行註冊試驗。

  • Operator

    Operator

  • Mayank Mamtani, B. Riley Securities.

    Mayank Mamtani,B. Riley 證券。

  • Mayank Mamtani - Analyst

    Mayank Mamtani - Analyst

  • Good morning, team. Thanks for taking our questions, and congrats on the progress. So maybe just following up on the prior comment about the new data that was presented regarding the CD4 T-cell superiority versus Fluzone high-dose, including for both CIC and NIV and H1N1 and H3N2.

    早安,各位團隊。感謝您回答我們的問題,並祝賀您的進展。因此,也許只是跟進關於 CD4 T 細胞優勢與 Fluzone 高劑量相比的新數據的評論,包括 CIC 和 NIV 以及 H1N1 和 H3N2。

  • Just curious, Rux, would you expect a relatively comparable data set being generated in the Sanofi study? And also wonder how important is the B strain specific immunogenicity in context of understanding the profile of standalone flu and CIC when you also obviously talk about what additional strategics are looking for? And then I have a quick follow-up.

    只是好奇,Rux,您是否期望在賽諾菲研究中產生一個相對可比的數據集?並且還想知道,當您顯然談論正在尋找哪些其他策略時,B 株特異性免疫原性在了解獨立流感和 CIC 的特徵方面有多重要?然後我有一個快速的跟進。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Rux, do you want to comment on Mayank's question?

    Rux,你想評論 Mayank 的問題嗎?

  • Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

    Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

  • Yes. So we cannot comment on Sanofi progress. Obviously, we are not purview to their data, and we can actually just relate our data from our experiments from this first cohort, as I was mentioning. It was very encouraging to see that the CD4 positive T-cells, polyfunctional were actually comparing very favorable, both in the case of tNIV and the CIC with a comparator, which is Fluzone high dose.

    是的。因此我們無法評論賽諾菲的進展。顯然,我們無權查看他們的數據,實際上,正如我所提到的,我們只能將我們第一批實驗的數據連結起來。令人鼓舞的是,多功能 CD4 陽性 T 細胞實際上與對照物(高劑量 Fluzone)相比非常有利,無論是在 tNIV 還是 CIC 的情況下。

  • As far as the specific strains, again, that is a little bit speculative because every year, as we know very well, in the case of influenza, you have different strains that are circulating. And the data that we have today is indicative of the direction of travel. How each and every one of these strains is going to behave in a particular season is actually to be seen and assessed.

    至於具體的病毒株,這還是有點推測,因為眾所周知,每年流感都會有不同的病毒株傳播。我們今天掌握的數據指明了旅行的方向。這些菌株在特定季節的具體表現如何,實際上仍有待觀察和評估。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • But we're encouraged by the data, Mayank. We're encouraged by the data, and we will keep driving forward with it.

    但數據讓我們感到鼓舞,Mayank。這些數據令我們感到鼓舞,我們將繼續努力向前邁進。

  • Mayank Mamtani - Analyst

    Mayank Mamtani - Analyst

  • Great. And my follow-up was around the three MTAs that you talked about. It seems this is growing over time. Could you just touch on how process goes to specific deliverables that lead to a financial transaction?

    偉大的。我的後續問題圍繞著您談到的三個 MTA。似乎隨著時間的推移,這種情況正在不斷增長。您能否簡單介紹流程如何實現具體的可交付成果並最終促成金融交易?

  • And do you have an understanding of what the new evolved BARDA framework is as they consider newer platforms to diversify for things like pandemic preparedness? Thanks again for taking my question.

    當他們考慮使用更新的平台來實現諸如大流行病防範等方面的多樣化時,您是否了解 BARDA 新演變的框架是什麼?再次感謝您回答我的問題。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Mayank, I want to make sure I fully understand your question. So I think it was two questions in one or two parts to your question. If I understand you correctly, the first part, you're asking about the process from MTAs migrating into a financial transaction. Is that the first part of your question?

    Mayank,我想確保我完全理解你的問題。所以我認為你的問題可以分成兩個部分。如果我理解正確的話,第一部分,您詢問的是 MTA 遷移到金融交易的過程。這是您問題的第一部分嗎?

  • Mayank Mamtani - Analyst

    Mayank Mamtani - Analyst

  • Yeah. So that's more industry-specific. And then I guess the second part to the BARDA question is that the BARDA framework is evolving also as it looks at different platforms beyond mRNAs. So I was just curious how maybe that progress, if any, is ongoing.

    是的。所以這更具行業針對性。然後我想 BARDA 問題的第二部分是,BARDA 框架也在不斷發展,因為它正在研究 mRNA 以外的不同平台。所以我只是好奇,如果有的話,這種進展是如何進行的。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • All right, Mayank. So to take the first question, obviously, that's limit to what I'm able to share here with you today and with everyone today due to the nature and sensitivity of conversations around business partnership deals, but MTAs are good because it allows potential partners to explore our technology in their own laboratory and see what it's capable of.

    好的,Mayank。因此,回答第一個問題,顯然,由於商業合作協議對話的性質和敏感性,我今天能夠與大家分享的內容有限,但 MTA 是件好事,因為它允許潛在的合作夥伴在自己的實驗室中探索我們的技術,看看它能做什麼。

  • And if it could solve needs that they have, then those said potential partners might want to discuss with us a potential deal for that or a license deal, et cetera. So that's why we're happy to get those MTAs signed because we believe in our technology.

    如果它能夠解決他們的需求,那麼那些潛在的合作夥伴可能想與我們討論潛在的交易或授權交易等等。所以我們很高興簽署這些 MTA,因為我們相信我們的技術。

  • We've done experiments internally in our own lab with multiple vaccines that either exist today and/or could exist. And we know what we believe we know what Matrix-M is capable of, and we're sharing some of that data under CDA with potential partners.

    我們在自己的實驗室內對多種現有和/或可能存在的疫苗進行了內部實驗。我們知道我們相信我們知道 Matrix-M 的功能,我們正在根據 CDA 與潛在合作夥伴分享部分數據。

  • And then, if they're doing experiments on their own and proving that out for themselves, that's further evidence that there may be something here for them to explore more deeply and perhaps in a financial arrangement.

    然後,如果他們自己做實驗並親自證明這一點,那就進一步證明他們可能可以更深入地探索一些東西,也許可以進行財務安排。

  • There's not much more we can say on this until these deals materialize, and then we'll be glad to share. So I think there was another comment about BARDA. So let me just pass that over to Silvia Taylor, and then we may have Ruxandra add to that as well. Go ahead, Silvia.

    在這些交易達成之前,我們對此不能透露太多,到時候我們會很高興地分享。所以我認為還有另一條關於 BARDA 的評論。因此,讓我把這個問題交給 Silvia Taylor,然後我們也可以讓 Ruxandra 來補充。繼續吧,西爾維亞。

  • Silvia Taylor - Executive Vice President, Chief Corporate Affairs and Advocacy Officer

    Silvia Taylor - Executive Vice President, Chief Corporate Affairs and Advocacy Officer

  • Hey, Mayank. Thanks so much for the question. Certainly, there is a lot right now that is evolving in the policy landscape. And I think as it relates to BARDA, look, we're excited about the asset that we have. We are excited about the data that Ruxandra talked about for our pandemic influenza asset. We continue to work with BARDA on potential funding.

    嘿,Mayank。非常感謝您的提問。當然,目前政策領域正在發生許多變化。我認為,就 BARDA 而言,我們對所擁有的資產感到非常興奮。我們對 Ruxandra 談到的有關我們的大流行性流感資產的數據感到非常興奮。我們將繼續與 BARDA 合作尋找潛在資金。

  • Really, we can't comment too much about what they're looking at in terms of other technology platforms. But we always talk about the importance of having our technology option available, and that's something that I can say is resonating. So as those conversations continue and we have anything to report, we'll definitely keep you posted.

    事實上,我們無法對他們正在關注的其他技術平台發表太多評論。但我們總是談論擁有可用的技術選擇的重要性,我可以說這是引起共鳴的。因此,隨著這些對話的繼續,並且我們有任何消息要報告,我們一定會及時通知您。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Yeah. There were news today about contracts getting canceled, Silvia, right? So maybe that's related to your question, Mike, but we believe there's still interest both from the Europeans and the US authorities in exploring potential with Novavax and our technology for pandemic preparedness. Rux, did you want to add a thought to that before we move on?

    是的。今天有關於合約被取消的消息,西爾維婭,對嗎?麥克,這可能與您的問題有關,但我們相信歐洲和美國當局仍然有興趣探索 Novavax 和我們的技術在流行病防範方面的潛力。魯克斯,在我們繼續之前,你想補充一點想法嗎?

  • Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

    Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

  • Thank you, John. The only thing that I wanted to add is as we have seen in the past in every single one of the applications, both for infectious diseases, generally speaking, and for the emerging and pandemic threats, there are a multitude of platforms that can be used to develop safe and efficacious vaccines.

    謝謝你,約翰。我唯一想補充的是,正如我們過去在每個申請中所看到的,無論是針對一般的傳染病,還是針對新出現的大流行威脅,都有大量平台可用於開發安全有效的疫苗。

  • We happen to have one of them, which is a protein-based platform with a Matrix-M adjuvant and our work that has been just recently published, as I've mentioned, in Nature Communications has shown that that is a viable alternative, at least for the moment in nonhuman primates.

    我們恰好有其中一種,它是一個基於蛋白質的平台,帶有 Matrix-M 佐劑,正如我所提到的,我們的研究最近發表在《自然通訊》上,表明這是一種可行的替代方案,至少目前在非人類靈長類動物中是如此。

  • Obviously, the work has to be continued in order to give data that is relevant for protection of the general public. But there are many platforms out there and the fact that we are moving to a platform or another is just a matter of choice and of science.

    顯然,為了提供與保護公眾相關的數據,這項工作必須持續下去。但是,市面上有很多平台,我們轉向某個平台只是選擇和科學的問題。

  • Operator

    Operator

  • Chris LoBianco, TD Securities.

    道明證券的 Chris LoBianco。

  • Chris LoBianco - Analyst

    Chris LoBianco - Analyst

  • Thanks for taking our questions. First, what is your level of confidence in positive efficacy data from the post-marketing Phase IV trial? And is there an interim analysis? And second, bigger picture question, is the company evaluating or open to acquiring or in-licensing clinical stage candidates?

    感謝您回答我們的問題。首先,您對上市後 IV 期試驗的積極療效數據的信心程度如何?有中期分析嗎?第二,更大的問題是,該公司是否正在評估或願意收購或授權臨床階段的候選人?

  • The company has a great platform, but it also has a highly experienced team and strong cash outlook, which could be a value-add for accelerating the development of external clinical stage candidates. Thank you.

    該公司不僅擁有出色的平台,還擁有經驗豐富的團隊和強勁的現金前景,這對於加速外部臨床階段候選藥物的開發具有增值作用。謝謝。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Could you repeat the first part of your question, please, Chris?

    克里斯,你能重複問題的第一部分嗎?

  • Chris LoBianco - Analyst

    Chris LoBianco - Analyst

  • Are you open to acquiring or in-licensing clinical stage candidates?

    您是否願意收購或授權臨床階段的候選人?

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Yeah. Right now, we're focused on external partnering and internal development of our own candidates via our pipeline. So that's the company's focus right now and then generating, first of all, optimizing our existing partnerships with, first and foremost, Sanofi, but also Takeda and with Serum and other organizations that we're proud to partner with and then investing in our technology platform where in the coming quarters, we intend to share some initial data that's emerging from those exciting assets that we're working on in very early stage.

    是的。目前,我們專注於透過我們的管道進行外部合作和內部候選人培養。這就是公司目前的重點,首先是優化我們與賽諾菲、武田、Serum 和其他我們很榮幸能與之合作的組織的現有合作夥伴關係,然後投資我們的技術平台,在未來幾個季度,我們打算分享一些我們正在早期階段研究的令人興奮的資產的初始數據。

  • And we're also exploring beyond infectious disease and seasonal respiratory viral vaccines, we're exploring the potential of Matrix-M in oncology. So we look forward to sharing some of that data in the coming quarters with you. Jim, did you want to add a little color to that?

    除了傳染病和季節性呼吸道病毒疫苗之外,我們還在探索 Matrix-M 在腫瘤學領域的潛力。因此,我們期待在未來幾季與您分享一些數據。吉姆,你想添加一點顏色嗎?

  • James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

    James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

  • Certainly. Thank you, John. So Chris, one of the things that we are emphasizing about how we unlock value from our technology platform is that the more people we can get this differentiated technology into their hands, driving more innovation, more vaccines, we believe that does the best for global health and for value creation.

    當然。謝謝你,約翰。因此,克里斯,關於如何從我們的技術平台釋放價值,我們強調的一點是,我們越能讓更多的人獲得這種差異化技術,就越能推動更多的創新、更多的疫苗,我們相信這對全球健康和價值創造最有利。

  • And for that reason, that is why we are so focused on ensuring folks understand what Matrix-M can do to either develop new vaccines or perhaps even improve upon existing. You saw earlier in our remarks, hey, we see an industry that last year, vaccines was over $57 billion.

    正因如此,我們才如此專注於確保人們了解 Matrix-M 可以如何開發新疫苗,甚至如何改進現有疫苗。您之前在我們評論中看到,我們看到去年疫苗產業的產值超過 570 億美元。

  • That McKinsey study notes it's going to grow over $75 billion and even beyond. We have a platform that has utility across multiple modalities. And we believe we've got the ability to really be a driver of growth in this industry, and that's where we're focused.

    麥肯錫的研究指出,這一數字將成長至 750 億美元甚至更多。我們有一個跨多種模式的實用平台。我們相信我們有能力真正成為這個產業成長的推動力,這也是我們關注的重點。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Yeah. Jim, well said. And Chris, that's a great question. Another way to look at our technology platform is it has utility, as Jim said, across multiple other vaccine platforms, could potentially have utility as a therapeutic, could potentially have utility beyond respiratory and infectious disease.

    是的。吉姆,說得好。克里斯,這是一個很好的問題。看待我們的技術平台的另一種方式是,它具有實用性,正如吉姆所說,跨多個其他疫苗平台,可能具有治療用途,可能具有超越呼吸道和傳染病的用途。

  • So the way we see our Matrix-M platform is that we haven't really yet begun to tap even the full potential at all of this platform. And we see it potentially being involved in multiple vaccines across multiple partners and coming out of Novavax for years to come.

    因此,我們認為 Matrix-M 平台尚未真正開始挖掘該平台的全部潛力。我們認為它有潛力在未來幾年內參與多個合作夥伴的多種疫苗研發,並由 Novavax 推出。

  • Operator

    Operator

  • Alec Stranahan, Bank of America.

    亞歷克·斯特拉納漢,美國銀行。

  • Alec Stranahan - Analyst

    Alec Stranahan - Analyst

  • Hey, guys. Thanks for the questions. Two from us. First, on the PMC, I appreciate the color Jim provided on the cost reimbursement. I guess what information can you share on the design, the size, the timing of the requested PMC? And second, how does the shifting wins at the FDA with RFK pulling mRNA vacs funding maybe provide a tailwind for you guys with potential partners? Thanks.

    嘿,大家好。感謝您的提問。我們有兩個。首先,關於 PMC,我很欣賞 Jim 在成本報銷方面提供的支援。我想您可以分享有關所要求的 PMC 的設計、尺寸和時間的哪些資訊?其次,隨著羅伯特甘迺迪 (RFK) 撤回 mRNA 疫苗資助,FDA 的勝利是否會為你們與潛在合作夥伴帶來順風?謝謝。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Rux, did you want to provide just a brief bit of color on the size, scope, scale of the PMC?

    Rux,能否簡單介紹一下 PMC 的規模、範圍和規模?

  • Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

    Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

  • Yeah. Thank you, John. So as you know, and as we have previously discussed, this is a post-marketing commitment. So basically, a study that occurs after the marketing authorization that could provide additional insights in a specific age population and looking at very clear endpoints.

    是的。謝謝你,約翰。如您所知,正如我們之前討論過的,這是一項上市後承諾。因此,基本上,在上市許可之後進行的研究可以為特定年齡人口提供額外的見解,並觀察非常明確的終點。

  • We do work towards starting the study as fast as possible and generating that data per the agreement with the regulatory agency. So we hope to start the study as soon as at the end of this year and obviously, generate the data in the next quarters thereafter.

    我們確實致力於盡快開始研究並根據與監管機構的協議產生數據。因此,我們希望最早在今年年底開始這項研究,並在接下來的幾季產生數據。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • And Alec, you can see the estimated cost of $70 million to $90 million. So that probably tells you a lot about the scope and scale and whatever type of burden that may be. The post-marketing commitments are not uncommon, and this is something we can handle, and I think Jim put it in a good perspective. Jim, anything to add on that?

    亞歷克,你可以看到預計成本為 7000 萬至 9000 萬美元。因此,這可能可以告訴你很多有關範圍和規模以及可能產生的負擔類型的信息。上市後承諾並不罕見,這是我們可以處理的事情,我認為吉姆對此提出了很好的看法。吉姆,還有什麼要補充的嗎?

  • James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

    James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

  • Just that we'll continue to support Sanofi and all of our partners to advance their interest. As you're seeing in this case, Sanofi is picking up the vast majority of expenses as we keep the momentum, right, in Nuvaxovid advancing in the marketplace.

    我們將繼續支持賽諾菲和我們所有的合作夥伴推進他們的利益。正如您在本案例中看到的,賽諾菲承擔了絕大多數費用,因為我們保持了 Nuvaxovid 在市場上不斷前進的勢頭。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • And Alec, your second question was about a tailwind, right? I found that very interesting when you see the news today about some grant funding being pulled from mRNAs by the current administration. What we are encouraged by actually is what we've seen is the continued investment in vaccines by peer companies and by large companies.

    亞歷克,你的第二個問題是關於順風的,對嗎?當您今天看到有關現任政府從 mRNA 中撤出一些撥款的新聞時,我發現這非常有趣。實際上,令我們感到鼓舞的是,我們看到同行公司和大公司繼續對疫苗進行投資。

  • You've seen a recent acquisition of a vaccine platform by Sanofi, partner that we have here at Novavax. You've seen investment being made with our partner Sanofi in their combination vaccines, both of which were fast tracked.

    您已經看到我們 Novavax 的合作夥伴賽諾菲最近收購了一個疫苗平台。您已經看到我們與合作夥伴賽諾菲對其聯合疫苗的投資,這兩種疫苗都得到了快速發展。

  • You see other companies investing in vaccine platform and technologies. You see a company like Pfizer in their earnings call mentioned vaccines as a top three priority of investment go forward for the company, right?

    您會看到其他公司正在投資疫苗平台和技術。您會看到像輝瑞這樣的公司在其收益電話會議上提到疫苗是該公司未來投資的三大重點之一,對嗎?

  • So companies that have been in vaccines for a long time who understand the value of vaccines for public health and for their bottom line are continuing to make those investments. So we see that from ourselves excited about the future. Our peers seem steady and excited about the future. And Silvia, you may want to comment on any potential tailwind based on the news today.

    因此,那些長期從事疫苗生產並了解疫苗對公共衛生和獲利價值的公司正在繼續進行這些投資。因此,我們從自身上看到了對未來的興奮。我們的同行似乎對未來很穩定並且充滿熱情。西爾維亞,您可能想根據今天的新聞對任何潛在的順風進行評論。

  • Silvia Taylor - Executive Vice President, Chief Corporate Affairs and Advocacy Officer

    Silvia Taylor - Executive Vice President, Chief Corporate Affairs and Advocacy Officer

  • Yeah. John, I mean, totally agree with what you said. I think when you're talking about vaccines, you're talking about different platforms. And I think certainly, there have been a lot of questions as we saw about the news that John mentioned yesterday in terms of BARDA pulling funding for mRNA.

    是的。約翰,我的意思是,完全同意你所說的。我認為當你談論疫苗時,你談論的是不同的平台。我認為,正如我們看到的約翰昨天提到的有關 BARDA 停止為 mRNA 提供資金的新聞一樣,肯定存在很多疑問。

  • We think that there's potential impact for us and of course, for our partner, Sanofi, in a couple of areas. I mean, one, I think, is development of pandemic influenza candidates. We've already talked about the fact that we have an asset. We're working with BARDA to explore the potential for funding. And there is the potential opportunity for us, particularly since other platforms may be taken out of consideration in that.

    我們認為這可能會對我們以及我們的合作夥伴賽諾菲在幾個領域產生影響。我的意思是,我認為其中之一就是開發大流行性流感候選藥物。我們已經討論過我們擁有資產的事實。我們正在與 BARDA 合作探索融資的可能性。這對我們來說是一個潛在的機會,特別是因為其他平台可能被排除在考慮範圍之外。

  • And then, I think, the other thing is seasonal execution and what it could mean for the market going forward. Certainly, I think right now, there is a lot of support for an alternative technology platform for protein-based technology platform. And we're excited to partner with Sanofi as they take the lead commercialization role and execute in this environment.

    然後,我認為另一件事是季節性執行及其對未來市場的意義。當然,我認為現在,人們對基於蛋白質的技術平台的替代技術平台有很多支援。我們很高興與賽諾菲合作,讓他們承擔主導商業化的角色並在這種環境中執行。

  • Operator

    Operator

  • Tom Shrader, BTIG.

    BTIG 的湯姆·施拉德 (Tom Shrader)。

  • Thomas Shrader - Equity Analyst

    Thomas Shrader - Equity Analyst

  • Good morning. Thanks for all the detail. The profitability comment for 2027, does that assume worldwide COVID vaccine use is about flat? And then a remedial one for Ruxandra. All your talk about more robust flu responses, the multiyear flu vaccines make sense ever or does the strain essentially always drift too much to make a vaccine that lasted two years valuable? Thank you.

    早安.感謝您提供的所有詳細資訊。對 2027 年獲利能力的評論是否假設全球 COVID 疫苗使用量基本持平?然後對 Ruxandra 進行補救。您一直在談論更強有力的流感應對措施,多年期流感疫苗是否有意義,或者病毒株是否總是發生過度漂移,以至於無法使有效期為兩年的疫苗變得有價值?謝謝。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Jim, do you want to take the first question?

    吉姆,你想回答第一個問題嗎?

  • James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

    James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

  • All right. Certainly. I appreciate the question. We have, as an objective of this company to drive value, the goal of reaching not just profitability, but sustainable and growing non-GAAP profitability. In addition, and in the interim, we're focused on making sure we have the financial strength with at least 1.5 years to 2 years or more of cash on hand.

    好的。當然。我很感謝你提出這個問題。作為這家公司推動價值的目標,我們的目標不僅是實現盈利,而且是實現可持續和不斷增長的非公認會計準則盈利。此外,在此期間,我們將致力於確保我們擁有足夠的財務實力,手頭上至少有 1.5 年到 2 年或更長的現金。

  • What you're seeing is we are setting up the company to unlock value. And then, with respect to the comments around as early as 2027, and of course, this is dependent on the performance of our partners, we see multiple paths to profitability. And I'll just give you a couple of examples that I emphasized a little bit earlier this year.

    您所看到的是,我們正在建立公司以釋放價值。然後,關於早在 2027 年左右的評論,當然,這取決於我們合作夥伴的表現,我們看到了多種盈利途徑。我只想給你們舉幾個我今年早些時候強調過的例子。

  • Our non-GAAP profitability profile, and I'm going to start with the breakeven and our expense profile target for 2027. We've told you R&D and SG&A of $250 million. And just to simplify math, imagine the cash OpEx there is about [$225 million -- $200 million to $225 million]. The ability to get to breakeven, therefore, would be in the case of a COVID vaccine. So think about our royalty rate on Sanofi, that's approximately 20% at around the midpoint.

    我們的非 GAAP 獲利狀況,我將從 2027 年的損益兩平和費用狀況目標開始。我們已告訴您研發銷售、一般及行政費用為 2.5 億美元。為了簡化計算,想像一下現金營運支出約為[2.25 億美元 -- 2 億美元到 2.25 億美元]。因此,實現收支平衡的能力取決於 COVID 疫苗。因此,想想我們對賽諾菲的專利費率,大約是中間值 20%。

  • We've given you a range, high-teens to low-20s. That would mean to be breakeven, Sanofi would be selling [1 billion] or more of the COVID vaccine, in a market that is [8 billion to 9 billion], you get a sense of the market share required, right, somewhere in the teens.

    我們為您提供了一個範圍,從十幾歲到二十多歲。這意味著要實現收支平衡,賽諾菲將銷售 [10 億] 或更多的新冠疫苗,在 [80 億到 90 億] 的市場中,你就能感覺到所需的市場份額,在十幾歲左右。

  • Then, another alternative, advancing the flu and CIC combination by Sanofi. The approval launch milestone itself is $225 million and would meet the objective on its own of getting us to breakeven just there with royalties and, of course, growing revenues on the back end of that launch. And that's me yet to even address other new collaborations that we're working towards that could, in turn, drive additional cash flow for the company.

    然後,另一個選擇是賽諾菲推進流感和 CIC 組合。批准啟動里程碑本身的價值為 2.25 億美元,這本身就足以讓我們透過特許權使用費來實現收支平衡,當然,在產品發布後還能增加收入。我什至還沒有談到我們正在努力實現的其他新合作,這些合作反過來可以為公司帶來額外的現金流。

  • And so, it is really the combination of the transformation into a lean and agile cost structure that creates, I'll call it, this far lower bar towards profitability and then the maturing and evolution of our partnering plan to drive cash flow to the company to not just breakeven, but grow a sustainable cash flow as a company over time to create value.

    因此,這實際上是向精益和敏捷成本結構的轉變,我稱之為,創造更低的盈利門檻,然後我們的合作計劃不斷成熟和發展,以推動公司現金流不僅實現收支平衡,而且隨著時間的推移,公司現金流可持續增長,從而創造價值。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Thank you, Jim. And Ruxandra, did you want to take the second question from Tom about flu vaccine, a multiyear flu vaccine? Thank you.

    謝謝你,吉姆。魯克桑德拉,你想回答湯姆關於流感疫苗(多年期流感疫苗)的第二個問題嗎?謝謝。

  • Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

    Ruxandra Draghia-Akli - Executive Vice President, Head of Research & Development

  • Well, as it's implied from your question, the influenza vaccines are typically subtype specific, yes, and that is changing every year, where there has been a tremendous effort in the field in the 35 years for the more universal vaccines. For the moment, those efforts have not been brought to fruition, I would say.

    嗯,正如您的問題所暗示的那樣,流感疫苗通常是針對亞型的,是的,而且每年都在變化,35 年來,人們在該領域付出了巨大的努力,以研製出更通用的疫苗。我想說,目前這些努力尚未有成果。

  • The data that we are generating is actually showing that our vaccine can offer a little bit broader immune protection. So slightly hetero subtypes might be in the scope of that protection and also, the T-cell data that we have generated, it's showing that we can probably confer a little bit of more durability of protection.

    我們產生的數據實際上表明我們的疫苗可以提供更廣泛的免疫保護。因此,略微異質的亞型可能處於這種保護範圍內,而且,我們產生的 T 細胞數據顯示,我們可能可以提供更持久的保護。

  • But we need to look at the durability of protection or that heterosubtypic protection in the context, the current vaccines might protect for a season, a season, it means a few months, what if we can actually protect for 6 months or for 12 months, it would already be an advancement versus the current state of science that we will be able to confer protection for two years or three years or for longer or have the universal flu vaccines, I actually think that the jury is out there. There have been so many efforts in that field, and unfortunately, they all have failed for the moment.

    但是,我們需要從保護的持久性或異亞型保護的角度來考慮,目前的疫苗可能只能保護一個季節,也就是幾個月,如果我們實際上能夠保護 6 個月或 12 個月,那麼與目前的科學水平相比,這已經是一個進步了,我們將能夠提供兩年、三年或更長時間的保護,或者擁有通用流感疫苗,實際上我認為陪審團已經在那裡了。人們在該領域已經做出了很多努力,但不幸的是,目前都失敗了。

  • Operator

    Operator

  • Geoff Meacham, Citi.

    花旗銀行的 Geoff Meacham。

  • Geoff Meacham - Analyst

    Geoff Meacham - Analyst

  • Hey, good morning, guys. This is Jarvi on for Jeff. Thanks for taking the question. As part of RKJ's comments yesterday about the BARDA situation and the framework, definitely, the comments on mRNA could be perceived as a tailwind for you guys.

    嘿,大家早安。這是賈維 (Jarvi) 為傑夫 (Jeff) 主持的。感謝您回答這個問題。作為 RKJ 昨天對 BARDA 情況和框架的評論的一部分,毫無疑問,對 mRNA 的評論可以被視為對你們的順風。

  • But among his comments, he also noted the desire for a universal vaccine rather than antigenic specific vaccines. Based on that, how do you think that might impact discussions going forward for interest for your flu and CIC vaccine for partners?

    但在他的評論中,他也指出人們渴望一種通用疫苗,而不是針對特定抗原的疫苗。基於此,您認為這會對未來有關您的合作夥伴的流感和 CIC 疫苗的興趣討論產生什麼影響?

  • And then a second question for us is you guys have noted interest in going in oncology and additional plans beyond respiratory vaccines. Given the importance of that beyond respiratory revenues, how do you think you guys might be able to fund those programs de novo on the current expectations of cash generation from the Sanofi collaboration? Thanks.

    然後我們要問的第二個問題是,你們注意到人們對腫瘤學以及呼吸道疫苗以外的其他計劃感興趣。考慮到除了呼吸系統收入之外的重要性,您認為您如何能夠根據目前對賽諾菲合作產生的現金流預期來為這些項目提供資金?謝謝。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Just want to make sure we unpack that clearly and do your question -- on your double question here. So the first part of that question, I believe, had to do with the universal vaccine and any impact on discussions or partnering. I think Ruxandra did an excellent job addressing that through a different question just a moment ago.

    只是想確保我們清楚地解釋這一點並回答你的問題——關於你這裡的雙重問題。因此,我認為,這個問題的第一部分與通用疫苗及其對討論或合作的影響有關。我認為 Ruxandra 剛才透過另一個問題很好地解決了這個問題。

  • So we don't currently see that as an impediment. That's something that has been tried for over 35 years, and there hasn't been a lot of success at all scientifically in that direction. And we're excited about any partnering discussions or any current partnerships we currently have with our technology platform.

    所以我們目前並不認為這是一個障礙。這項嘗試已經進行了 35 多年,但從科學角度來看並未取得太大的成功。我們對我們的技術平台目前進行的任何合作討論或任何現有合作關係感到非常興奮。

  • And then the second part of your question, if you could just condense that and restate so we can get it correctly.

    然後,對於您問題的第二部分,如果您可以將其濃縮並重述,以便我們可以正確理解。

  • Geoff Meacham - Analyst

    Geoff Meacham - Analyst

  • Sure, of course. Yes, just the interest in going in oncology, if you could give us more details on that and plans for what other areas you guys may have interest in going into, and then also your confidence in being able to run those programs based on current projections of revenue generation from the Sanofi collaboration.

    當然可以。是的,只是對進入腫瘤學領域感興趣,如果您可以向我們提供更多關於該領域的詳細信息和您可能感興趣的其他領域的計劃,以及您對能夠根據目前對賽諾菲合作產生的收入的預測來運行這些項目的信心。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Right, very good question. Appreciate that. We're excited about the potential outcomes of our explorations in oncology. We'll be looking forward to in the coming quarters, sharing some initial data coming out of those explorations, and we're very excited about the potential there for our technology. Let me let Jim handle your question about the financial runway to support our portfolio programs. Jim?

    對,非常好的問題。非常感謝。我們對腫瘤學探索的潛在成果感到非常興奮。我們期待在接下來的幾個季度中分享這些探索產生的一些初步數據,我們對我們的技術的潛力感到非常興奮。讓我讓吉姆來處理您關於支持我們的投資組合計劃的財務跑道的問題。吉姆?

  • James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

    James Kelly - Chief Financial Officer, Executive Vice President, Treasurer

  • Well, certainly, and maybe reinforcing and this is the reason why I really like this question, it reinforces the thoughtful approach we're using to our business model of finding outside this company experts who can utilize our technology to drive new areas of vaccine innovation where we don't have to do it ourselves.

    嗯,當然,也許還有強化作用,這也是我非常喜歡這個問題的原因,它強化了我們在商業模式中採用的深思熟慮的方法,即在公司外部尋找可以利用我們的技術推動疫苗創新新領域的專家,而我們不必自己動手。

  • And so, in the case of oncology, we've recognized the importance of the right adjuvant playing a role, right, in oncology. And we don't intend to be an oncology company. We don't. However, we'll generate the right type of data to encourage you know how vast that marketplace is, to encourage those players to collaborate with us, have access to our technology to advance what Matrix could be.

    因此,就腫瘤學而言,我們已經認識到正確的佐劑在腫瘤學中發揮作用的重要性。我們也不打算成為腫瘤學公司。我們沒有。然而,我們會產生正確類型的數據,以鼓勵您了解這個市場有多廣闊,並鼓勵那些參與者與我們合作,使用我們的技術來推動 Matrix 的發展。

  • And the return on that could be exceptional. And so, I think what you heard today from Rux, just some preliminary information that we're learning leads us to believe we're on the right path, and we're looking forward to partnering with others.

    而其回報可能是非常豐厚的。所以,我認為您今天從 Rux 那裡聽到的只是我們正在了解的一些初步信息,這讓我們相信我們走在正確的道路上,我們期待與其他人合作。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Yeah. And today, Jim outlined once again very clearly, our lean financial platform that we're building and the continued cost reduction efforts of this organization that we've been under for the last few years and continue to execute upon while keeping our capabilities and focusing our investments in the right areas that are supportive of our strategy.

    是的。今天,吉姆再次非常清楚地概述了我們正在建立的精益財務平台,以及過去幾年來我們一直在努力降低組織的成本,並將繼續執行這些努力,同時保持我們的能力並將我們的投資集中在支持我們策略的正確領域。

  • And that's inclusive of the investments in our portfolio that we've already shared, four different programs plus exploration in oncology plus H5N1 discussions, et cetera, all of that is inclusive and as part of that lean financial platform that Jim outlined clearly here. And we've always said, if we do find a gem coming out of our portfolio, it will be clear that it is one, and at that time, we may choose to bring that forward.

    這包括我們已經分享的投資組合中的投資,四個不同的項目加上腫瘤學探索加上 H5N1 討論等等,所有這些都是包容性的,並且是 Jim 在這裡明確概述的精益財務平台的一部分。我們總是說,如果我們確實從我們的投資組合中發現了一顆寶石,那麼很明顯它是一顆寶石,到那時,我們可能會選擇提前。

  • But right now, it's all contemplated as part of the current financials Jim shared.

    但現在,這一切都被視為吉姆分享的當前財務狀況的一部分。

  • Operator

    Operator

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

    我們的問答環節到此結束。我想將會議交還給約翰·雅各布斯 (John Jacobs) 來做結束語。

  • John Jacobs - President, Chief Executive Officer, Director

    John Jacobs - President, Chief Executive Officer, Director

  • Thank you very much, everyone. We appreciate you joining the call today and look forward to seeing you in the near term. Have a great day.

    非常感謝大家。我們感謝您今天參加電話會議,並期待不久的將來與您見面。祝你有美好的一天。

  • Operator

    Operator

  • This conference has now concluded. Thank you for attending today's presentation. You may not disconnect.

    此次會議現已結束。感謝您參加今天的演講。您不能斷開連線。