Novavax Inc (NVAX) 2024 Q3 法說會逐字稿

Good morning, and welcome to Novavax's third quarter 2024 financial results and operational highlights conference call.

早安，歡迎參加 Novavax 2024 年第三季財務業績和營運亮點電話會議。

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

（操作員說明）請注意此事件正在被記錄。

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

現在我想將會議交給投資者關係副總裁路易斯·薩奈 (Luis Sanay)。

Please go ahead.

請繼續。

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

早安，感謝大家今天加入我們討論我們 2024 年第三季的營運亮點和財務表現。

A press release announcing our results is currently available on our website at novavax.com and an audio archive of this conference call will be available on our website later today.

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

Please turn to slide 2.

請翻到投影片 2。

Before we begin with prepared remarks.

在我們開始之前準備好的評論。

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 value drivers and near term 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 preclinical product candidates full year 2024 financial guidance and Novavax's future financial or business performance.

我需要提醒您的是，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、其價值驅動因素和近期優先事項、其合作夥伴關係以及對潛在特許權使用費、里程碑和成本報銷的期望相關的陳述、對其COVID 19 疫苗的製造能力、時間安排、生產和交付的預期、Novavax 臨床和臨床前候選產品的開發、2024 年全年財務指導以及Novavax 未來的財務或業務績效。

Each forward-looking statement contained in this presentation is subject to certain risks and uncertainties that could cause actual results to differ materially from those projected in such statements.

本簡報中包含的每項前瞻性陳述均受到某些​​風險和不確定性的影響，這些風險和不確定性可能導致實際結果與此類陳述中的預測有重大差異。

Additional information regarding these factors appears under the heading, cautionary note regarding forward-looking statements in the presentation we issued this morning and under the heading risk factors in our most recent Form 10-K and subsequent Form 10-Q filed with the Securities and Exchange Commission available at sec.gov and our website at novavax.com.

有關這些因素的更多資​​訊出現在我們今天早上發布的演示文稿中有關前瞻性陳述的警告標題下，以及我們向證券交易委員會提交的最新10-K 表格和隨後的10-Q 表格中的風險因素標題下。

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原始日期的情況，我們不承擔更新或修改任何這些陳述的義務。

Please turn to slide 3.

請翻到幻燈片 3。

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

本簡報也引用了非公認會計準則財務指標，該指標是針對賽諾菲根據賽諾菲協議報銷的費用進行調整後的合併研發和銷售及一般管理費用的前瞻性資訊。

Please turn to slide 4.

請翻到幻燈片 4。

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

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

Additionally, John Trizzino, our President and Chief Operating Officer will provide an update on our current commercial season and Dr. Bob Walker, Chief Medical Officer will discuss our clinical development and R&D strategy.

此外，我們的總裁兼營運長 John Trizzino 將提供我們當前商業季節的最新信息，首席醫療官 Bob Walker 博士將討論我們的臨床開發和研發策略。

Finally, Jim Kelly, Chief Financial Officer and treasurer will provide an overview of our financial results.

最後，財務長兼財務主管 Jim Kelly 將概述我們的財務表現。

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

我現在想將電話轉交給約翰·雅各布斯。

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

謝謝你，路易斯，也謝謝大家加入我們。

Please turn to slide 5.

請翻到投影片 5。

I'm pleased to be with you here today, along with members of our executive team to discuss Novavax's progress during the third quarter as well as how we have advanced the new corporate growth strategy that we outlined during our second quarter call in August.

我很高興今天能與大家一起，與我們的執行團隊成員一起討論 Novavax 在第三季度的進展，以及我們如何推進我們在 8 月份第二季度電話會議中概述的新企業增長戰略。

This strategy is focused on driving future value from additional business development activities and organic research and development using our proven technology, all while reshaping the company into a leaner and more agile organization.

該策略的重點是利用我們成熟的技術從額外的業務開發活動和有機研發中驅動未來價值，同時將公司重塑為更精簡、更敏捷的組織。

This strategy has already resulted in the Sanofi partnership we announced this year, which has enabled us to transition away from Novavax's prior business model of devoting all our resources and time to commercializing one product, our COVID-19 vaccine, and to move instead toward additional value-generating activities, which we will talk about more today.

這項策略已經促成了我們今年宣布的賽諾菲合作夥伴關係，這使我們能夠擺脫Novavax 之前將所有資源和時間投入到一種產品（即我們的COVID-19 疫苗）商業化的業務模式，轉而轉向更多的產品創造價值的活動，我們今天將詳細討論。

First, I want to take a moment to recap the four key drivers of value for this strategy and then share with you both the progress we have already made and our next steps on each.

首先，我想花點時間回顧一下該策略的四個關鍵價值驅動因素，然後與大家分享我們已經取得的進展以及我們在每個方面的後續步驟。

The four value drivers are value driver one, the Sanofi partnership, value driver two, our late-stage pipeline, CIC and flu, value driver three, leveraging our proven technology platform to drive additional partnerships and deals and value driver four, our emerging early stage pipeline.

四個價值驅動因素是價值驅動因素一、賽諾菲合作夥伴關係、價值驅動因素二、我們的後期管道、CIC 和流感、價值驅動因素三、利用我們成熟的技術平台推動更多合作夥伴關係和交易以及價值驅動因素四、我們新興的早期產品階段管道。

We intend to deliver on these value drivers using a more lean corporate infrastructure built on the core capabilities needed to execute this new approach and disciplined expense management, on which we have already made significant progress and we will elaborate on later in the call.

我們打算使用更精益的企業基礎設施來實現這些價值驅動因素，該基礎設施建立在執行這種新方法和嚴格的費用管理所需的核心能力的基礎上，我們已經在這方面取得了重大進展，我們將在稍後的電話會議中詳細說明。

So first, let's talk about value driver one, the Sanofi partnership.

首先，我們來談談價值驅動因素之一，即與賽諾菲的合作關係。

As we discussed last quarter, the partnership with Sanofi is a license and collaboration agreement that combines Novavax's proprietary protein and nanoparticle technologies, matrix adjuvant and our R&D expertise with Sanofi's world-class leadership in launching and commercializing innovative vaccines.

正如我們上季度討論的那樣，與賽諾菲的合作是一項許可和合作協議，它將Novavax 的專有蛋白質和奈米顆粒技術、基質佐劑以及我們的研發專業知識與賽諾菲在推出和商業化創新疫苗的世界級領導地位結合。

Sanofi will take the lead co-commercialization role for our COVID-19 vaccine starting in 2025, enabling us to monetize our existing COVID-19 vaccine program through double digit royalties from Sanofi sales into the future.

從2025 年開始，賽諾菲將在我們的COVID-19 疫苗聯合商業化中發揮主導作用，使我們能夠透過賽諾菲未來銷售額的兩位數特許權使用費，將現有的COVID-19疫苗項目貨幣化。

We also have the potential for multiple additional revenue streams generated from other vaccines developed by Sanofi, either in combination with our existing COVID-19 product or using our Matrix-M adjuvant as they look to leverage the power of our proven technology.

我們還有可能從賽諾菲開發的其他疫苗中獲得多種額外收入來源，無論是與我們現有的COVID-19 產品結合使用，還是使用我們的Matrix-M 佐劑，因為他們希望利用我們成熟技術的力量。

As a reminder, in the second quarter, we received an initial cash payment of $500 million upfront and an approximately $70 million equity investment in Novavax.

提醒一下，在第二季度，我們收到了 5 億美元的預付款和 Novavax 約 7,000 萬美元的股權投資。

We are also eligible to receive up to $700 million in additional milestone payments related to our COVID-19 vaccine and Sanofi's own combination COVID flu vaccine.

我們還有資格獲得與我們的 COVID-19 疫苗和賽諾菲自己的聯合 COVID 流感疫苗相關的高達 7 億美元的額外里程碑付款。

Along with future milestone payments and royalties we anticipate from these programs, we also have the potential for additional royalties and or milestones from other vaccines developed either in combination with our existing COVID-19 product or using our Matrix-M technology.

除了我們預計從這些計劃中獲得的未來里程碑付款和特許權使用費外，我們還有可能從與我們現有的COVID-19 產品結合或使用我們的Matrix-M 技術開發的其他疫苗獲得額外的特許權使用費和/或里程碑。

As you can see, Sanofi's strong global presence and proven track record in developing and commercializing vaccines, combined with Novavax's R&D expertise, has created the potential for this partnership to drive significant value for years to come, both for our shareholders and the people who would have broadened access to our vaccine technology and the protection it can provide.

正如您所看到的，賽諾菲在疫苗開發和商業化方面強大的全球影響力和良好的業績記錄，再加上Novavax 的研發專業知識，為這一合作夥伴關係創造了潛力，可以在未來幾年為我們的股東和利害關係人創造巨大價值。

Our second value driver is Novavax's late stage pipeline.

我們的第二個價值驅動因素是 Novavax 的後期管道。

Our late stage pipeline is comprised of our COVID-19 influenza combination and stand-alone influenza vaccine candidates.

我們的後期產品線由我們的 COVID-19 流感組合疫苗和獨立的流感候選疫苗組成。

We believe that combination vaccines such as our CIC candidate represent a significant market opportunity, and we're excited about the prospect of advancing these assets.

我們相信，像我們的 CIC 候選疫苗這樣的組合疫苗代表著一個重要的市場機會，我們對推進這些資產的前景感到興奮。

In addition, our stand-alone influenza vaccine program is based on a platform that has demonstrated enhanced immunogenicity in late-stage trials.

此外，我們的獨立流感疫苗計畫是基於一個已在後期試驗中證明免疫原性增強的平台。

And we believe that if successful, this could be the first and only recombinant based protein adjuvanted flu vaccine in the market and one which can serve as the foundation to advance an innovative and differentiated pandemic influenza program as well.

我們相信，如果成功，這可能是市場上第一個也是唯一一個基於重組的蛋白質佐劑流感疫苗，並且也可以作為推進創新和差異化大流行性流感計劃的基礎。

As we've previously communicated, our intention is to partner these assets.

正如我們之前所傳達的，我們的目的是與這些資產合作。

Dr. Bob Walker will provide updates on this program shortly.

鮑勃沃克博士將很快提供有關該計劃的最新資訊。

And now moving on to value driver three, which is to leverage our proven technology platform to drive additional partnerships and deals.

現在轉向第三個價值驅動因素，即利用我們成熟的技術平台來推動更多的合作夥伴關係和交易。

Our proven tech platform consists of both our Matrix-M adjuvant and our nanoparticle protein based technology, which we believe provide us the potential for multiple business development opportunities with a diverse set of potential partners across a range of vaccines.

我們經過驗證的技術平台由 Matrix-M 佐劑和基於奈米顆粒蛋白的技術組成，我們相信這為我們提供了與一系列疫苗領域的各種潛在合作夥伴一起實現多種業務發展機會的潛力。

We believe Matrix-M holds incredible promise, not just to develop our own vaccines as we've already seen with our marketed COVID-19 product, but importantly, to also potentially improve other companies existing vaccines and or enable them to develop new vaccines using our adjuvant.

我們相信Matrix-M 擁有令人難以置信的前景，不僅可以開發我們自己的疫苗，就像我們在已上市的COVID-19 產品中看到的那樣，而且重要的是，它還可以潛在地改進其他公司現有的疫苗，或使他們能夠使用我們的佐劑。

Last quarter, we shared data from existing vaccines combined with Matrix-M to demonstrate how our adjuvant can be leveraged to potentially improve them.

上個季度，我們分享了現有疫苗與 Matrix-M 結合的數據，以展示如何利用我們的佐劑來潛在地改善它們。

The data we showed of inactivated influenza and bacterial polysaccharide vaccines adjuvanted with our Matrix-M are just two examples of the significant value we believe our adjuvant could provide to the existing vaccine portfolios of other companies, and we continue to explore other ways to leverage its potential.

我們展示的用我們的Matrix-M 佐劑的滅活流感疫苗和細菌多醣疫苗的數據只是我們相信我們的佐劑可以為其他公司現有疫苗組合提供重要價值的兩個例子，我們將繼續探索其他方法來利用其佐劑。

And finally, value driver four, our emerging early-stage pipeline.

最後，價值驅動因素四，我們新興的早期管道。

Our fourth value driver focuses on generating additional value from our tech platform through the development of a new diversified pipeline.

我們的第四個價值驅動因素著重於透過開發新的多元化管道從我們的技術平台中產生額外價值。

Employing a disciplined approach, we intend to develop an early-stage pipeline based on our proven technology platform, starting from our core of infectious disease and potentially going beyond that core into other areas where we see the most unmet medical need and the greatest potential for our technology.

我們打算採用嚴格的方法，基於我們經過驗證的技術平台開發一個早期管道，從我們的傳染病核心開始，並可能超越該核心進入我們認為最未滿足的醫療需求和最大潛力的其他領域。技術。

Importantly, we intend to expand our pipeline strategically using a rigorous set of guiding principles aimed to focus our time and investments on the highest value programs.

重要的是，我們打算使用一套嚴格的指導原則來策略性地擴大我們的管道，旨在將我們的時間和投資集中在最高價值的項目上。

This will include considerations such as scientific rationale and reasons to believe our technology can be differentiated and win in a specific therapeutic area, market opportunity and the level of unmet medical need, emerging competitive pipelines, attractiveness of the asset to other companies and ability to partner and several other factors to help us make high-quality choices with our investments in R&D.

這將包括諸如科學原理和相信我們的技術能夠在特定治療領域脫穎而出並獲勝的理由、市場機會和未滿足的醫療需求的水平、新興的競爭渠道、資產對其他公司的吸引力以及合作能力等考慮因素以及其他幾個因素可以幫助我們在研發投資方面做出高品質的選擇。

Importantly, we intend to execute this strategy in a capital efficient manner, one that maintains our flexibility and preserves the potential for maximum value creation.

重要的是，我們打算以資本有效的方式執行這項策略，從而保持我們的靈活性並保留最大價值創造的潛力。

Dr. Bob Walker will expand further on both how we intend to apply these guiding principles and our next steps during his portion of today's call.

鮑勃沃克博士將在今天的電話會議中進一步闡述我們打算如何應用這些指導原則以及我們的後續步驟。

So in summary, our corporate growth strategy channels all of our resources into driving value from our proven technology platform via partnering in R&D and to doing so in a much more lean and efficient organization.

總而言之，我們的企業成長策略將我們所有的資源引導到透過研發合作從我們成熟的技術平台中驅動價值，並在一個更精簡和高效的組織中實現這一目標。

For the remainder of this year and in line with our key value drivers, we're focused on executing our four priorities, which you will see on slide 6.

在今年剩餘的時間裡，根據我們的關鍵價值驅動因素，我們將專注於執行我們的四個優先事項，您將在幻燈片 6 中看到。

Priority one, the successful execution of our partnership with Sanofi.

第一要務是成功執行我們與賽諾菲的合作關係。

Priority two, driving incremental value from our technology platform with the advancement of our CIC and flu programs, the ongoing development of an emerging early-stage pipeline and pursuing new business development opportunities.

第二個優先事項是，透過 CIC 和流感專案的進步、新興早期管道的持續開發以及尋求新的業務發展機會，推動我們的技術平台產生增量價值。

Priority three, further reduction of our R&D and SG&A costs in line with our guidance, along with implementing additional reductions to scale as we enter 2025 and beyond.

第三個優先事項是，根據我們的指導進一步降低研發和銷售管理費用，並在進入 2025 年及以後進一步削減規模。

And priority four, delivery of our updated COVID-19 vaccine for the '24, '25 vaccination season.

第四個優先事項是為「24」、「25」疫苗接種季提供更新的 COVID-19 疫苗。

Before I hand the call over to additional members of our team, I want to take a moment to welcome Dr. Ruxandra Draghia, our new Head of R&D, who started just yesterday.

在將電話轉交給我們團隊的其他成員之前，我想花一點時間歡迎 Ruxandra Draghia 博士，他是我們昨天剛上任的新任研發主管。

Ruxandra brings more than 20 years of extensive clinical corporate and global public health expertise to Novavax, and we believe she will be instrumental as we evaluate our future pipeline and opportunities for our tech platform.

Ruxandra 為 Novavax 帶來了 20 多年豐富的臨床企業和全球公共衛生專業知識，我們相信她將在我們評估我們未來的產品線和技術平台的機會時發揮重要作用。

You will hear more from Ruxandra in the coming weeks as she settles into her new role.

在接下來的幾週內，隨著 Ruxandra 適應新角色，您將聽到更多關於她的消息。

Now to discuss our third quarter in more detail, I'd like to turn the call to John Trizzino for our operating updates.

現在，為了更詳細地討論我們的第三季度，我想致電約翰·特里齊諾 (John Trizzino)，以了解我們的營運最新情況。

John?

約翰？

Thank you, John.

謝謝你，約翰。

Please turn to slide 7.

請翻到幻燈片 7。

We are pleased with the progress in our COVID vaccine program through the first part of the '24, '25 season.

我們對 24、25 賽季第一階段的新冠疫苗計畫的進展感到高興。

And with this progress, we are already seeing that season to date, Novavax's vaccine administrations in the US already outperform those done in the entire '23, '24 season with our current weekly market share averaging about 3%.

隨著這一進展，我們已經看到該季節迄今為止，Novavax 在美國的疫苗管理已經超過了整個 23、24 季節的表現，我們目前的每週市佔率平均約為 3%。

Let me take a moment to highlight our progress last quarter, all of which we believe will position Sanofi for success when they take over lead commercialization of Nuvaxovid in the '25, '26 season.

讓我花點時間強調我們上季度的進展，我們相信所有這些都將使賽諾菲在 25、26 賽季接管 Nuvaxovid 的商業化主導業務時取得成功。

Please turn to slide 8.

請翻到幻燈片 8。

Our primary commercial efforts remain dedicated to the largest market opportunity, the US.

我們的主要商業努力仍然致力於最大的市場機會，即美國。

We initiated our '24, '25 COVID-19 commercial season in mid-September, shortly after achieving our goal to get our vaccine authorized at the end of August, in line with the timing of the competitors in order to facilitate a timely season start.

在實現我們的疫苗在 8 月底獲得授權的目標後不久，我們於 9 月中旬啟動了「24」、「25」COVID-19 商業季節，與競爭對手的時間安排一致，以促進季節的及時開始。

Compared to last season, this was a significant improvement in timing for Novavax.

與上賽季相比，Novavax 在時機上有了顯著的進步。

At the same time, the current COVID-19 vaccine season initiated three weeks earlier in the US as compared to last season, and we believe that if current trends continue, the total market size could be approximately 40 million to 50 million shots in arms this season.

同時，與上一季相比，目前的 COVID-19 疫苗季在美國提前了三週，我們相信，如果目前的趨勢持續下去，今年的總市場規模可能約為 4,000 萬至 5,000 萬劑。 。

Specific progress for this season also included our product presentation, offering our vaccine in a prefilled syringe compared to last year's five dose vial presentation, broader access and improved contracting, doubling the number of locations with Novavax that would be available in over 30,000 locations, including CVS Pharmacy, Rite Aid, Walgreens, Meijer and hundreds of other grocers and thousands of independent pharmacies.

本季度的具體進展還包括我們的產品展示，與去年的五劑小瓶展示相比，以預裝注射器提供我們的疫苗，更廣泛的訪問和改進的合同，將Novavax 的銷售地點數量增加了一倍，將在30,000 多個地點提供，包括CVS Pharmacy、Rite Aid、Walgreens、Meijer 以及數百家其他雜貨店和數千家獨立藥局。

Higher visibility of Novavax on vaccine schedulers in most major retailers and a targeted commercial approach, executing marketing and selling activities targeted to select opportunity markets rather than last year's broader national approach.

Novavax 在大多數主要零售商的疫苗調度程序中的知名度更高，並採用有針對性的商業方法，針對特定機會市場執行行銷和銷售活動，而不是去年更廣泛的全國性方法。

Please turn to slide 9.

請翻到投影片 9。

In situations with more favorable market access contracts, Novavax is demonstrating the ability to compete with the mRNA vaccines.

在市場准入合約更優惠的情況下，Novavax 正在展示與 mRNA 疫苗競爭的能力。

In one regional supplier of vaccinations, Novavax has achieved approximately 70% market share as reported by that retailer.

根據該零售商報告，在一家疫苗接種區域供應商中，Novavax 已獲得約 70% 的市場份額。

In addition, we executed on a targeted marketing strategy geared towards select age cohorts.

此外，我們也針對特定年齡層執行了有針對性的行銷策略。

And to date, we are seeing that 53% of the Novavax claims are in our primary target audience of 65 plus.

迄今為止，我們發現 53% 的 Novavax 聲明針對的是 65 歲以上的主要目標受眾。

It is important to note that this audience aligns to ACIP's recent recommendation for this age cohort to revaccinate this season after their initial updated seasonal dose.

值得注意的是，這些受眾符合 ACIP 最近針對該年齡層的建議，即在初次更新季節性劑量後在本季重新接種疫苗。

At the same time, we experienced some challenges that have prevented us from achieving our initial market share goals, namely minimum purchase commitment contracts for mRNA vaccines, limited initial retail stocking of our vaccine, a limited commercial infrastructure of just 30% of our previous size and three month product expiry dating for our prefilled syringe, which we intend to work with the FDA to improve for future seasons.

同時，我們遇到了一些阻礙我們實現最初市場份額目標的挑戰，即 mRNA 疫苗的最低採購承諾合約、疫苗的初始零售庫存有限、商業基礎設施有限，規模僅為我們之前的 30%我們的預充式註射器的產品有效期為三個月，我們打算與FDA 合作，在未來的季節中進行改進。

We are managing through these challenges, and we do not believe our current market share is representative of the overall demand and potential of our COVID-19 vaccine.

我們正在應對這些挑戰，但我們認為我們目前的市場份額並不能代表我們的 COVID-19 疫苗的整體需求和潛力。

In fact, of the greater than 30,000 retail outlets stocking our vaccine, we have seen an increase in the level of restocking quantities, demonstrating growing demand.

事實上，在超過 30,000 家庫存我們疫苗的零售店中，我們看到補貨數量增加，這表明需求不斷增長。

As we advance through the remainder of the season, we believe these efforts will continue to strengthen the opportunity and establish a solid foundation for Sanofi in preparation for next season.

隨著本賽季剩餘時間的推進，我們相信這些努力將繼續加強機會，並為賽諾菲為下個賽季做準備奠定堅實的基礎。

We continue to work closely with our partner to enable a seamless transition of lead commercial activities.

我們繼續與合作夥伴密切合作，以實現主要商業活動的無縫過渡。

We believe that Sanofi's significant scale and strong presence, coupled with the increasing consumer demand we have seen for Novavax's COVID-19 vaccine will result in successful upcoming seasons for the product.

我們相信，賽諾菲的巨大規模和強大影響力，加上我們看到的消費者對 Novavax 的 COVID-19 疫苗不斷增長的需求，將導致該產品在接下來的幾個季度取得成功。

Please turn to slide 10.

請翻到投影片 10。

Outside of the US, we were pleased to receive marketing authorization for our updated vaccine from the European Commission last month.

在美國以外，我們很高興上個月從歐盟委員會獲得了我們更新疫苗的營銷授權。

We remain focused on conducting a lean, limited and targeted commercial season in Europe and Asia, while we continue to work with Sanofi to position them to take over lead commercial operations for the '25, '26 season.

我們仍然專注於在歐洲和亞洲進行精益、有限和有針對性的商業季節，同時我們繼續與賽諾菲合作，讓他們接管 25、26 季節的主要商業運營。

In other regions, as we've noted in the past, we are continuing to prioritize the completion of our APAs with the intent to transition key markets to Sanofi.

在其他地區，正如我們過去所指出的，我們將繼續優先完成預約定價安排，旨在將關鍵市場轉移給賽諾菲。

In summary, we believe there remains a continued demand for COVID-19 vaccines and believe that Sanofi with its large commercial reach and greater resources will drive additional market share in 2025 and beyond.

總之，我們認為對 COVID-19 疫苗的需求仍然持續，並相信賽諾菲憑藉其巨大的商業影響力和更多的資源將在 2025 年及以後推動更多的市場份額。

With that, I'd like to hand the call to Bob to discuss our research and development updates.

至此，我想將電話轉給鮑勃，討論我們的研發最新情況。

Thank you, John.

謝謝你，約翰。

Please turn to slide 11 and 12.

請翻至投影片 11 和 12。

Today, I will elaborate on important updates in our research and development program that support each of the four key value drivers John Jacobs outlined earlier.

今天，我將詳細闡述我們的研發計劃的重要更新，這些更新支持約翰·雅各布斯先前概述的四個關鍵價值驅動因素。

I'll start with our updated 2024, '25 COVID-19 vaccine, followed by our late stage program in CIC and influenza, then I'll discuss expanding potential opportunities for Matrix-M and conclude with an update on our internal preclinical pipeline and our R&D strategy going forward.

我將從我們更新的 2024 年 '25 COVID-19 疫苗開始，然後是我們在 CIC 和流感方面的後期計劃，然後我將討論擴大 Matrix-M 的潛在機會，並以我們內部臨床前管道的更新和我們未來的研發策略。

Please turn to slide 13.

請翻到投影片 13。

With regard to our 2024, '25 COVID-19 vaccine targeting the JN.1 strain.

關於我們針對 JN.1 株的 2024 年 '25 COVID-19 疫苗。

We continue to monitor the performance of our vaccine against newly circulating variants in non-clinical models.

我們繼續在非臨床模型中監測我們的疫苗針對新流行變種的表現。

And these data continue to demonstrate broad cross neutralizing antibody responses to each new strain, including both KP.3.1.1 and XEC.

這些數據繼續證明了對每種新菌株（包括 KP.3.1.1 和 XEC）的廣泛交叉中和抗體反應。

Please turn to slide 14.

請翻到投影片 14。

This slide shows neutralizing antibody responses pre and post receipt of our JN.1 vaccine in rhesus macaques.

這張幻燈片顯示了恒河猴在接種 JN.1 疫苗前後的中和抗體反應。

You can see that the antibody tighters are robust against all of the variants tested, including the KP.3.1.1 and XEC variants that are now widely circulating.

您可以看到，抗體緊縮劑對所有測試的變體都具有很強的穩健性，包括現在廣泛傳播的 KP.3.1.1 和 XEC 變體。

So these data for the newer variants indicate that our vaccine should provide acceptable coverage against the variants that are currently circulating.

因此，這些新變種的數據表明，我們的疫苗應該能夠針對目前正在傳播的變種提供可接受的覆蓋範圍。

Please turn to slide 15.

請翻到投影片 15。

I'll now move on to our late-stage pipeline comprised of our COVID-19 influenza combination or CIC vaccine program and our seasonal influenza vaccine program, which is the second value driver that John discussed.

我現在將繼續討論我們的後期管道，包括我們的 COVID-19 流感組合或 CIC 疫苗計劃和我們的季節性流感疫苗計劃，這是約翰討論的第二個價值驅動因素。

We issued a press release yesterday stating that the clinical hold on our IND for our CIC and stand-alone influenza vaccine candidates has been removed by the US FDA.

我們昨天發布了一份新聞稿，指出美國 FDA 已取消對我們的 CIC 和獨立流感疫苗候選藥物 IND 的臨床擱置。

The safety event recently reported by a participant in our Phase 2 study was reviewed in detail by the FDA, along with our responses to their comments and they determined that we had satisfactorily addressed all clinical hold issues.

FDA 詳細審查了我們的 2 期研究參與者最近報告的安全事件以及我們對其評論的回應，他們確定我們已經令人滿意地解決了所有臨床擱置問題。

The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine.

向 FDA 提供的資訊支持了我們的評估，即嚴重不良事件與我們的疫苗無關。

We intend to begin enrolling our Phase 3 immunogenicity trial as soon as possible.

我們打算盡快開始註冊我們的 3 期免疫原性試驗。

Please turn to slide 16.

請翻到投影片 16。

Data from our now completed Phase 2 CIC study support non-inferior immunogenicity of both our CIC and influenza vaccines.

我們現已完成的第 2 期 CIC 研究的數據支持我們的 CIC 和流感疫苗的非劣免疫原性。

During the Phase 3 pre-IND process, the FDA and Novavax aligned on a single Phase 3 trial for both candidates with an updated trial design as shown in the graphic on the right.

在 IND 前的第 3 階段過程中，FDA 和 Novavax 就兩個候選藥物進行了一項第 3 階段試驗，並更新了試驗設計，如右圖所示。

Participants will be randomized to one of four vaccine arms and immunologic comparisons to establish non-inferiority for CIC will be made to the Novavax COVID-19 vaccine and to an age-recommended commercial influenza vaccine.

參與者將被隨機分配到四種疫苗組中的一種，並對 Novavax COVID-19 疫苗和年齡推薦的商業流感疫苗進行免疫學比較，以確定 CIC 的非劣效性。

Immunologic comparisons to establish non-inferiority for Novavax seasonal influenza vaccine will also be made to the same commercial flu vaccine.

也將與同一種商業流感疫苗進行免疫學比較，以確定 Novavax 季節性流感疫苗的非劣效性。

The trial will enroll adults aged 65 years and older and is currently planned to be conducted in Australia and New Zealand during their current spring and upcoming summer.

該試驗將招募 65 歲及以上的成年人，目前計劃在澳洲和紐西蘭當前的春季和即將到來的夏季進行。

Please turn to slide 17.

請翻至投影片 17。

Now I'd like to turn to our proven technology platform, our third value driver, and to the attributes of Matrix-M that we believe could be of significant interest to partners with established or developing vaccine franchises.

現在我想談談我們經過驗證的技術平台，我們的第三個價值驅動因素，以及Matrix-M 的屬性，我們相信這些屬性可能會讓擁有已建立或正在開發的疫苗特許經營權的合作夥伴產生重大興趣。

On prior earnings calls, we presented data supporting each of the Matrix-M attributes listed on this slide.

在先前的財報電話會議上，我們提供了支援本投影片中列出的每個 Matrix-M 屬性的資料。

We believe these attributes provide the potential for Matrix-M to improve the activity of existing vaccines as in the case of inactivated egg based influenza vaccines, and we previously shared those data while maintaining excellent tolerability.

我們相信這些特性為 Matrix-M 提供了提高現有疫苗活性的潛力，就像滅活雞蛋流感疫苗一樣，我們之前分享了這些數據，同時保持了良好的耐受性。

And we believe Matrix-M has the potential to be antigen sparing and reduce cost of production, such as for pneumococcal polysaccharide vaccines, and we've previously shared those data as well.

我們相信 Matrix-M 有潛力節省抗原並降低生產成本，例如肺炎鏈球菌多醣體疫苗，我們之前也分享過這些數據。

We also believe that Matrix-M may enable new vaccines to be developed for certain poorly immunogenic pathogens that have not been regarded as good vaccine candidates to date.

我們也相信，Matrix-M 可能有助於為某些迄今尚未被視為良好候選疫苗的免疫原性較差的病原體開發新疫苗。

During the third quarter, Novavax entered into a material transfer agreement with a leading pharmaceutical company to evaluate Matrix-M in a bacterial vaccine program.

第三季度，Novavax 與一家領先的製藥公司簽訂了材料轉讓協議，以評估細菌疫苗計畫中的 Matrix-M。

We intend to continue to seek out similar opportunities to further leverage Matrix-M's proven adjuvant activity and impressive safety profile, which includes its role as a component of two authorized vaccines, our COVID-19 vaccine for ages 12 and over and R21 for malaria prevention recommended for infants as young as five months of age.

我們打算繼續尋找類似的機會，以進一步利用Matrix-M 經過驗證的佐劑活性和令人印象深刻的安全性，其中包括其作為兩種授權疫苗（適用於12 歲及以上兒童的COVID-19 疫苗和用於預防瘧疾的R21）的組成部分的作用建議五個月大的嬰兒使用。

Please turn to slide 18.

請翻到幻燈片 18。

Finally, I would like to provide updates on our emerging early-stage pipeline, our fourth value driver.

最後，我想提供有關我們新興的早期管道的最新信息，這是我們的第四個價值驅動因素。

John talked about the ongoing strategic assessment of our technology platform, which is a major focus for our R&D organization and we are excited to continue this assessment under the leadership of our new Head of R&D, Dr. Ruxandra Draghia.

John 談到了對我們技術平台正在進行的策略評估，這是我們研發組織的主要關注點，我們很高興能在新任研發主管 Ruxandra Draghia 博士的領導下繼續進行這項評估。

Our strategy to drive value through innovation in R&D that leverages our validated technology platform is based on expansion beyond our existing core expertise in COVID-19, influenza and CIC vaccines.

我們透過利用我們經過驗證的技術平台的研發創新來推動價值的策略是基於超越我們在 COVID-19、流感和 CIC 疫苗方面現有核心專業知識的擴展。

Our R&D strategy will be executed within the framework and key guiding principles John noted earlier.

我們的研發策略將在約翰之前提到的框架和關鍵指導原則內執行。

First, we intend to move forward with RSV combinations and pandemic flu, which are disease areas that leverage our existing experience and internal expertise in infectious disease.

首先，我們打算推進 RSV 組合和大流行性流感，這些疾病領域利用了我們在傳染病方面的現有經驗和內部專業知識。

Both are based on our protein nanoparticle and Matrix-M technology platform, and we hope to advance both through IND enabling activities in the near term.

兩者都基於我們的蛋白質奈米顆粒和 Matrix-M 技術平台，我們希望在短期內透過 IND 支援活動來推進兩者。

We will focus on exploring RSV containing combinations that would give this vaccine candidate the highest probability of success given the number of RSV stand-alone vaccines now available.

鑑於目前可用的 RSV 獨立疫苗數量，我們將重點探索包含 RSV 的組合，這將使該候選疫苗獲得最高的成功機率。

Characterization of our RSV candidate is ongoing in preparation for an IND enabling toxicology study that is planned to start next year.

我們正在對 RSV 候選藥物進行表徵，為計劃於明年開始的 IND 毒理學研究做準備。

For the pandemic flu candidate, toxicology studies are now underway and we are actively discussing funding opportunities with the relevant government agencies to support early and late-stage clinical development and the manufacturing of this promising candidate.

對於大流行性流感候選藥物，毒理學研究正在進行中，我們正在與相關政府機構積極討論資助機會，以支持這種有前途的候選藥物的早期和後期臨床開發和生產。

Outside of RSV combinations and pandemic influenza, our next step is to identify other infectious diseases that are or could become vaccine preventable, meet other predefined criteria and for which our technology could possess differentiating attributes for potential advancement to IND.

除了RSV 組合和大流行性流感之外，我們的下一步是確定其他可以或可能透過疫苗預防的傳染病，滿足其他預先定義的標準，並且我們的技術可以擁有差異化的屬性，從而有可能推進IND。

We will prioritize areas where we believe we can make a meaningful impact while leveraging our existing expertise.

我們將優先考慮我們認為可以在利用現有專業知識的同時產生有意義影響的領域。

Areas that are currently under consideration for more rigorous scientific and business case analyses range from reactivated infections that are known to be vaccine preventable such as Varicella zoster, where our technology has produced a candidate VZV vaccine that we believe may be better tolerated and comparably effective to the currently approved vaccine and with a large market size to areas of great need such as antibiotic associated infections such as C difficile, where the scientific challenges are significant and where we believe our technology could have a meaningful impact.

目前正在考慮進行更嚴格的科學和商業案例分析的領域包括已知可透過疫苗預防的再活化感染，例如水痘帶狀皰疹，我們的技術已生產出一種候選VZV 疫苗，我們認為該疫苗可能具有更好的耐受性並且相對有效目前已批准的疫苗，在急需的領域（例如艱難梭菌等抗生素相關感染）具有很大的市場規模，這些領域的科學挑戰非常嚴峻，我們相信我們的技術可以產生有意義的影響。

We intend to evaluate these and other opportunities in infectious disease, and we intend to prioritize our efforts over the next few months to make decisions on which preclinical programs we want to advance.

我們打算評估傳染病領域的這些機會和其他機會，並打算在接下來的幾個月中優先考慮我們的工作，以決定我們想要推進哪些臨床前計畫。

Finally, the third step in our portfolio development process.

最後，我們的投資組合開發過程的第三步。

We potentially may expand more broadly beyond infectious diseases into therapeutic areas where we believe there are real opportunities for our technology to augment and improve on current approaches.

我們可能會更廣泛地擴展到傳染病以外的治療領域，我們相信我們的技術有真正的機會來增強和改進目前的方法。

If so, we would plan to leverage specialized scientific knowledge and robust translational models to evaluate a range of chronic diseases where our technology could lead to the development of preclinical constructs to advance the proof of mechanism and proof of concept studies and beyond.

如果是這樣，我們將計劃利用專業的科學知識和強大的轉化模型來評估一系列慢性疾病，我們的技術可以促進臨床前結構的開發，以推進機制證明和概念驗證研究等。

Here, we are evaluating therapeutic areas, for example, oncology, immune-mediated diseases and diseases of protein aggregation, where initial evaluations of our technology could be used to quickly generate proof of concept, go no go data before establishing a formal development program.

在這裡，我們正在評估治療領域，例如腫瘤學、免疫介導的疾病和蛋白質聚集疾病，我們的技術的初步評估可用於快速生成概念證明，在建立正式的開發計劃之前不提供數據。

We plan to apply a low cost approach with rapid in vitro assessments and non-clinical models to identify a small number of specific diseases for further focused assessment.

我們計劃採用低成本方法，透過快速體外評估和非臨床模型來識別少數特定疾病，以進行進一步有針對性的評估。

Key considerations include balancing available resources and necessary spend by leveraging existing screening technologies and collaborations.

關鍵考慮因素包括透過利用現有篩選技術和合作來平衡可用資源和必要支出。

We will engage in a similar comprehensive and rigorous scientific and business assessment that would be needed to support further advancement.

我們將進行類似的全面、嚴格的科學和商業評估，以支持進一步的進步。

We continue to evaluate opportunities under this framework, and we will provide regular updates as we execute this strategy.

我們將繼續評估該框架下的機會，並在執行該策略時定期提供最新資訊。

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

現在要討論我們本季的財務狀況，我想將電話交給吉姆。

Thank you, Bob.

謝謝你，鮑伯。

Please turn to slide 19.

請翻至投影片 19。

Today, we announced our financial results for the third quarter of 2024.

今天，我們公佈了 2024 年第三季的財務表現。

Details of our results can be found in our press release and in our 10-Q filing.

有關結果的詳細信息，請參閱我們的新聞稿和 10-Q 文件。

Please turn to slide 20.

請翻到投影片 20。

We remain focused on improving the financial strength and performance of Novavax to drive shareholder value.

我們仍然專注於提升 Novavax 的財務實力和業績，以提高股東價值。

I'll start by covering key themes for the third quarter and a look towards the remainder of 2024 and beyond.

我將首先介紹第三季的關鍵主題，並展望 2024 年剩餘時間及以後的情況。

For the third quarter of 2024, Novavax recorded total revenue of $85 million, including $38 million primarily from the US market sales and reflecting initial stocking orders that were in line with our expectations.

2024年第三季度，Novavax 的總收入為 8,500 萬美元，其中 3,800 萬美元主要來自美國市場銷售，反映出最初的庫存訂單符合我們的預期。

Although we are seeing an improvement in market share compared to the 2023 vaccination season, our current market share of approximately 3% is trending below our full season expectations.

儘管與 2023 年疫苗接種季相比，我們看到市佔率有所改善，但我們目前約 3% 的市佔率趨勢低於我們整個疫苗季的預期。

And as a result, we are updating our full year 2024 total revenue guidance.

因此，我們正在更新 2024 年全年總收入指引。

As we continue to transform Novavax into a more lean and agile organization, we reduced our Q3 2024 R&D and SG&A expenses by 26% compared to prior year.

隨著我們繼續將 Novavax 轉型為更精簡和敏捷的組織，我們在 2024 年第三季的研發和銷售、一般行政費用 (SG&A) 與前一年相比減少了 26%。

For full year 2024, we are reiterating the guidance range for R&D and SG&A expenses of between $700 million and $750 million.

對於 2024 年全年，我們重申研發和銷售、一般管理費用指引範圍為 7 億美元至 7.5 億美元。

At midpoint, this reflects a decrease of approximately 40% and $500 million as compared to full year 2023.

從中期來看，與 2023 年全年相比，這一數字減少了約 40%，即 5 億美元。

Novavax is prepared to initiate an additional cost reduction program to reduce combined R&D and SG&A expenses in 2025 and 2026 to better align our go-forward cost structure with our value creation strategy.

Novavax 準備啟動一項額外的成本削減計劃，以減少 2025 年和 2026 年的研發和銷售及管理費用合計，從而更好地使我們的未來成本結構與我們的價值創造策略保持一致。

We maintained a strong cash position and ended the third quarter of 2024 with over $1 billion in cash and accounts receivables.

我們維持強勁的現金狀況，截至 2024 年第三季末，現金和應收帳款超過 10 億美元。

And finally, we remain focused on prioritizing the completion of our APAs to enable a smooth transition of commercial leadership to Sanofi.

最後，我們仍然專注於優先完成預約定價安排，以實現商業領導地位順利過渡到賽諾菲。

Please turn to slide 21 for a more detailed view of our third quarter 2024 financial results.

請參閱投影片 21，以了解我們 2024 年第三季財務表現的更詳細資訊。

For the third quarter of 2024, we recorded total revenue of $85 million compared to $187 million for the same period in 2023.

2024 年第三季度，我們的總營收為 8,500 萬美元，而 2023 年同期為 1.87 億美元。

Of note, product sales for the third quarter of 2024 were $38 million compared to $2 million in the same period for 2023 as a result of higher US market sales in the current quarter.

值得注意的是，由於本季美國市場銷售額增加，2024 年第三季的產品銷售額為 3,800 萬美元，而 2023 年同期為 200 萬美元。

Our cost of sales for the third quarter of 2024 were $61 million as compared to $99 million for the same period in 2023.

我們 2024 年第三季的銷售成本為 6,100 萬美元，而 2023 年同期為 9,900 萬美元。

For the third quarter of 2024, Novavax's combined R&D and SG&A expenses of $158 million reflects a 26% reduction from the same period in 2023.

2024年第三季度，Novavax的研發與銷售、一般行政費用合計為1.58億美元，較2023年同期減少26%。

Approximately $30 million of this current quarter amount is related to commercial and medical affairs related spend that we do not expect to incur after this year.

本季金額約 3000 萬美元與商業和醫療事務相關支出有關，我們預計今年之後不會產生這些支出。

Based on this, we believe we're on track to further reduce our cost structure in 2025 and beyond.

基於此，我們相信我們預計在 2025 年及以後進一步降低成本結構。

Please turn to slide 22.

請翻到投影片 22。

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

我們致力於創造一個更精簡和敏捷的組織，以適應公司的市場機會。

To advance that goal, we expect to reduce our R&D plus SG&A to approximately $350 million in 2026 and approximately $1.4 billion, an 80% decrease when compared to full year 2022.

為了推進這一目標，我們預計在 2026 年將研發加銷售、一般管理費用分別減少至約 3.5 億美元和約 14 億美元，與 2022 年全年相比減少 80%。

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

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

To achieve this, Novavax is prepared to initiate an additional cost reduction program to better align our go-forward cost structure with our value creation strategy.

為了實現這一目標，Novavax 準備啟動一項額外的成本削減計劃，以更好地調整我們的未來成本結構與我們的價值創造策略。

As we transition lead commercial activities to Sanofi, this will enable the reduction of commercial and supply chain costs.

當我們將主要商業活動轉移給賽諾菲時，這將能夠降低商業和供應鏈成本。

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

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

Please turn to slide 23.

請翻至投影片 23。

Now turning to our updated financial guidance for the full year 2024.

現在轉向我們更新的 2024 年全年財務指引。

We are revising our guidance for total revenue to between $650 million and $700 million from our prior guidance of $700 million to $800 million.

我們正在將總收入指引從先前的 7 億美元至 8 億美元修改為 6.5 億美元至 7 億美元。

At midpoint of $675 million, this is a $75 million decrease to our total revenue guidance.

以 6.75 億美元的中位數計算，這比我們的總收入指引減少了 7,500 萬美元。

Based on our revised full year 2024 product sales guidance, we now expect product sales of between $175 million and $225 million.

根據我們修訂後的 2024 年全年產品銷售指引，我們目前預期產品銷售額在 1.75 億美元至 2.25 億美元之間。

At midpoint of $200 million, this revised guidance includes $100 million from APAs delivered in the first half of 2024 and $100 million commercial market product sales from the US market and ex US markets in the second half of 2024.

在 2 億美元的中點上，修訂後的指引包括 2024 年上半年交付的預約定價安排中的 1 億美元，以及 2024 年下半年美國市場和美國以外市場的 1 億美元商業市場產品銷售額。

The decrease of $125 million at midpoint compared to prior guidance is driven primarily by our COVID-19 trends in the US market.

與先前的指引相比，中間值減少了 1.25 億美元，這主要是由於我們在美國市場的 COVID-19 趨勢所致。

We are also revising and increasing our full year 2024 licensing, royalties and other revenue guidance and now expect to achieve $475 million.

我們也正在修訂和增加 2024 年全年授權、特許權使用費和其他收入指導，目前預計將達到 4.75 億美元。

The $50 million increase compared to the prior guidance is driven by a combination of revenue recognition for the upfront payment and cost reimbursement under the Sanofi agreement.

與先前的指導相比，增加了 5000 萬美元，這是由於賽諾菲協議下的預付款和成本報銷的收入確認相結合。

A few comments on our expectations for 2025 and beyond.

關於我們對 2025 年及以後的預期的一些評論。

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

對於其餘的 APA 協議，我們的目的是友好談判或提供劑量，或在適當的情況下退出協議，目標是這些活動在未來的基礎上實現現金流中性或有利。

To be conservative, we have removed APA sales from our forward-looking revenue expectations until further clarity is available for each.

保守地說，我們已將 APA 銷售從前瞻性收入預期中刪除，直到每項收入進一步明確為止。

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

我們目前的營運計劃，包括多年費用目標，強調了實現我們目標的途徑，即在以里程碑和特許權使用費的形式收到賽諾菲協議的現金流之前，維持至少一到兩年的手頭現金。

Please turn to slide 24.

請翻到投影片 24。

As we enter 2025, the future cash flows to the company under the Sanofi agreement become of greater importance.

隨著我們進入 2025 年，根據賽諾菲協議，公司的未來現金流變得更加重要。

We expect up to $700 million in near-term COVID-19 and flu COVID combination milestones under that agreement.

根據該協議，我們預計近期 COVID-19 和流感 COVID 組合里程碑將高達 7 億美元。

For the $350 million in Nuvaxovid COVID-19 milestones, we expect to complete database lock of a related pediatric clinical trial in the fourth quarter of 2024, which would enable earning of the first $50 million milestone.

對於 Nuvaxovid COVID-19 里程碑中的 3.5 億美元，我們預計將在 2024 年第四季度完成相關兒科臨床試驗的資料庫鎖定，這將實現第一個 5000 萬美元里程碑的收入。

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

此里程碑的收入確認將在截至 2026 年的過渡服務期內分配。

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

協議項下的所有其他里程碑將在獲得時全額確認。

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

1.75 億美元的 BLA 里程碑預計將與我們的 BLA PDUFA 行動日期和批准一致，目前目標是 2025 年 4 月。

The $225 million authorization transfer milestones are expected to follow as we enable Sanofi to commercialize Nuvaxovid in the US and Europe for the 2025, '26 vaccination season.

隨著我們幫助賽諾菲在 2025 年 26 疫苗接種季在美國和歐洲將 Nuvaxovid 商業化，預計將實現 2.25 億美元的授權轉讓里程碑。

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

我們目前預計將於 2026 年底完成過渡服務義務，預計將實現 7,500 萬美元的技術轉移里程碑。

For the Sanofi flu COVID-19 program, there are two milestones totaling $350 million related to the development and first US commercial sale.

對於賽諾菲流感 COVID-19 項目，有兩個里程碑，涉及開發和首次美國商業銷售，總價值達 3.5 億美元。

Sanofi recently noted on their Q3 earnings call that they expect to start their Phase 1, 2 study this year.

賽諾菲最近在第三季財報電話會議上指出，他們預計今年開始第一、第二階段研究。

And if that data are positive, they would move towards Phase 3 in 2025.

如果這些數據是正面的，他們將在 2025 年進入第三階段。

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

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

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

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

Novavax will support Sanofi as prepares to advance all programs associated with this agreement and Novavax will be eligible for cost reimbursement across a host of spend categories.

Novavax 將支持賽諾菲準備推進與該協議相關的所有計劃，並且 Novavax 將有資格獲得一系列支出類別的費用報銷。

We expect this reimbursement to occur during 2025 and 2026 as we supply product, conduct R&D and technical transfer activities.

我們預計這筆補償將在 2025 年和 2026 年期間進行，因為我們供應產品、進行研發和技術轉移活動。

For products supplied to Sanofi, we will book both cost of goods sold and reimbursement revenue.

對於供應給賽諾菲的產品，我們將記錄銷售成本和報銷收入。

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

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

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

說到這裡，我想將電話轉回給約翰，讓他做一些結束語。

Thank you, Jim.

謝謝你，吉姆。

Please turn to slide 25.

請翻到投影片 25。

Thank you all for joining us today and thank you to all our employees for their continued efforts in advancing our business.

感謝大家今天加入我們，並感謝我們所有員工為推動我們的業務所做的持續努力。

I am proud of our accomplishments to date and excited about our opportunity to drive value in the future with our new strategy.

我對我們迄今為止所取得的成就感到自豪，並對我們有機會透過新策略在未來推動價值感到興奮。

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

我現在想將電話轉給我們的接線生進行問答。

(Operator Instructions)

（操作員說明）

Roger Song, Jefferies LLC.

羅傑‧宋，傑富瑞有限責任公司。

Thank you.

謝謝。

Thanks for the update and then congrats on the speedy removal of the clinical hold on your CIC and flu program.

感謝您的更新，並祝賀您的 CIC 和流感計劃的臨床暫停迅速解除。

So a couple of questions from us.

我們有幾個問題。

Maybe first on the clinical hold removal.

也許首先是臨床保留的解除。

Understanding you want to start the Phase 3 as soon as possible.

了解您希望盡快開始第三階段。

Can you give us some clarity around the timing of the start?

您能為我們介紹一下開始的時間嗎？

What will be the gating factor for you to start the Phase 3?

您開始第三階段的限制因素是什麼？

And then given this severe SAE occurrence, how much additional safety requirement now is in place or required by the FDA, any potential post-marketing requirement suggested or recommended by the FDA?

那麼考慮到這種嚴重的 SAE 事件，FDA 現在有多少額外的安全要求或要求多少，FDA 建議或建議的任何潛在的上市後要求？

I have a couple of follow-ups.

我有幾個後續行動。

Thank you, Roger.

謝謝你，羅傑。

I'll let Bob Walker address your questions, starting with timing.

我將讓鮑勃沃克（Bob Walker）回答您的問題，首先從時間安排開始。

Bob?

鮑伯？

Great, thanks.

太好了，謝謝。

Well, first of all, let me just say we got the news on Friday.

好吧，首先，我想說的是我們週五收到了這個消息。

So we after market close or close to market close.

所以我們在收盤後或接近收盤時。

So we've had the weekend and yesterday to assess.

所以我們用周末和昨天的時間來評估。

And I would say that we're working on study logistics right now.

我想說，我們現在正在研究後勤工作。

Our intent, of course, as you've heard is to start the trial as soon as possible.

當然，正如您所聽到的，我們的目的是盡快開始試驗。

We're not prepared to give you a specific starting date at this moment, but expect that in the coming weeks, we will be able to provide more clarity on the -- specifically when we plan to start the trial.

目前我們不准備向您提供具體的開始日期，但預計在接下來的幾週內，我們將能夠提供更清晰的信息，特別是我們計劃何時開始試驗。

Let me just remind you that the safety event that was reported to FDA led to the clinical hold was determined by us not to be related to study vaccine.

我只是提醒您，向 FDA 報告的導致臨床暫停的安全事件經我們確定與研究疫苗無關。

And based on the FDA's reaction, it appears that they concur with our assessment.

根據 FDA 的反應，他們似乎同意我們的評估。

It certainly substantiates our assessment.

這無疑證實了我們的評估。

So in terms of additional safety precautions that need to be introduced, they are really the standard safety oversight and monitoring that essentially was already in the trial or with a slight tweaks in response to the back and forth while we were assessing this event.

因此，就需要引入的額外安全預防措施而言，它們實際上是標準的安全監督和監控，基本上已經在試驗中，或者在我們評估這一事件時根據來回的情況進行了輕微的調整。

So what I'm trying to say is we don't expect a significant impact from any of those kind of operational changes to the protocol other than the standard types of impacts that are -- that everyone encounters when they make administrative changes to a protocol.

所以我想說的是，除了每個人對協議進行管理更改時都會遇到的標準類型的影響之外，我們預計對協議的任何此類操作更改都不會產生重大影響。

And Roger, this is John.

羅傑，這是約翰。

Thank you for your congratulations on that holds being lifted.

感謝您對解除保留表示祝賀。

We're very excited about.

我們非常興奮。

And we were -- to just build upon Bob's answer, we were ready to go on track to go, Bob, in Q4 with our study.

我們——以鮑伯的答案為基礎，我們準備好在第四季的研究中步入正軌，鮑伯。

So having this lifted is excellent.

因此，將其解除是非常好的。

There's just a little bit of work we need to do.

我們只需要做一點工作。

But in the near-term, we think we'll be able to start that study.

但在短期內，我們認為我們將能夠開始這項研究。

We're just avoiding giving a specific date yet as we're still digesting the feedback from FDA, which is clear and expected, and we just have to get that reset and going.

我們只是避免給出具體日期，因為我們仍在消化 FDA 的回饋，這是明確且預期的，我們只需要重新設定並繼續進行。

But we think in the near-term, we'll be able to restart that study.

但我們認為在短期內，我們將能夠重新啟動這項研究。

We're very excited about it.

我們對此感到非常興奮。

Thank you.

謝謝。

Great.

偉大的。

Thanks for the clarity.

感謝您的澄清。

Yeah, I understand you just got the news and then thank you for confirming.

是的，我知道您剛剛收到訊息，感謝您的確認。

You're still going to start a trial in.

您仍將開始試用。

So maybe shift to

所以也許轉移到

--

--

No, Roger, let me just clarify.

不，羅傑，讓我澄清一下。

We're not giving a time frame right now on it.

我們現在沒有給出時間表。

We're just digesting the feedback and have to reset the logistics to get it started.

我們正在消化回饋，必須重新調整後勤工作才能開始。

So it may be sooner rather than later.

所以可能宜早不宜遲。

But we don't want to give a specific date yet until we finish our planning that's what we were saying.

但在我們完成計劃之前，我們不想給出具體日期，這就是我們所說的。

So not giving a specific time frame yet, but in the near-term, we should be able to provide clarity and we think we'll be able to start it in the near term so.

因此，目前還沒有給出具體的時間框架，但在短期內，我們應該能夠提供明確的訊息，並且我們認為我們將能夠在短期內啟動它。

Got it.

知道了。

Okay, your turn.

好的，輪到你了。

Thank you and then shifting towards the commercial.

謝謝你，然後轉向商業。

So you got $38 million commercial sales mostly coming from us.

因此，您獲得了 3800 萬美元的商業銷售額，其中大部分來自我們。

Can you give us some additional color around the stocking versus the real short arm?

與真正的短臂相比，你能給我們一些關於襪子周圍的額外顏色嗎？

So we all track a IQVIA data since you got, at least from the for a third party, the script capturing you have one around 160,000 scripts in the retail channel.

因此，我們都追蹤 IQVIA 數據，因為您至少從第三方獲得了腳本，捕獲您在零售通路中擁有約 160,000 個腳本。

So how should we think about the percentage captured by the retail versus non retail?

那我們該如何考慮零售與非零售所佔的百分比呢？

And the last part of the question is, what's your working assumption on the net price per dose?

問題的最後一部分是，您對每劑淨價的工作假設是什麼？

Thank you.

謝謝。

Go ahead John, you want to take that one?

來吧，約翰，你想拿那個嗎？

Yeah, so just a little bit of clarification on some of the stats there.

是的，所以只是對其中的一些統計數據進行一些澄清。

I think what we're seeing so far with the IQVIA data which everybody is monitoring is a season that started a bit earlier than last year.

我認為到目前為止，我們所看到的每個人都在監控的 IQVIA 數據是一個比去年早一點的季節。

And so we're seeing reflected in some of the trend lines.

我們看到一些趨勢線反映出來。

We're seeing a leveling off of shots in arms into the marketplace through retail pharmacies.

我們看到透過零售藥局進入市場的劑量正在趨於平穩。

And I think that's consistent with what you would see as a normal pattern of vaccination.

我認為這與您所看到的正常疫苗接種模式是一致的。

The trend lines that we're seeing are also indicating that there's a slight increase in overall demand in shots in arms this year over last, we'll have to see how the rest of the season progresses to determine whether or not that's going to hold true for the balance of the full season, the full '24, '25 season just to be clear about how some other numbers have been reported by other companies.

我們看到的趨勢線也表明，今年武器射擊的總體需求比去年略有增加，我們必須看看本賽季剩餘時間的進展情況，以確定這種情況是否會持續下去對於整個賽季的其餘部分來說，整個“24”、“25”賽季都是如此，只是為了弄清楚其他公司是如何報告其他一些數字的。

This would take us through the first quarter.

這將帶我們度過第一季。

So far, we're holding at about approximately 3% market share.

到目前為止，我們佔有大約 3% 的市場份額。

We're significantly greater even season to date than we did in all of last season, some 3 times to 4 times, the total number of what we did already in market expect that to continue.

本賽季迄今為止，我們的表現比上賽季整個賽季的表現要好得多，大約是 3 倍到 4 倍，這是我們已經在市場上所做的事情的總數，預計這種情況會繼續下去。

As I mentioned, the script also, we were focusing on the 65 plus market.

正如我在劇本中提到的，我們也專注於 65 歲以上市場。

There's some updated policy that's going to enable some second doses to be administered late in the year and early into next year so that we'll see some benefit there.

有一些更新的政策將允許在今年年底和明年初注射第二劑疫苗，這樣我們就會看到一些好處。

But where we -- the IQVIA data is hovering somewhere around total 800,000 doses or so shots in arms at this point.

但我們的 IQVIA 數據目前徘徊在大約 80 萬劑左右。

And I think that's significant.

我認為這很重要。

Got it.

知道了。

Thank you.

謝謝。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Good morning team.

早上好，團隊。

Thanks for taking our questions and welcome aboard Ruxandra.

感謝您提出我們的問題，歡迎加​​入 Ruxandra。

So maybe just on following up on the prior question.

所以也許只是跟進之前的問題。

Just thinking forward-looking in terms of having the vaccine now as part of Sanofi's product portfolio and distribution channel next year, are you able to comment on what trends around net price?

只是考慮到現在將疫苗作為明年賽諾菲產品組合和分銷渠道的一部分，您能否對淨價的趨勢發表評論？

I know market share might be too early to comment on, but just split by channel and some of the pricing dynamics could look like.

我知道評論市場份額可能還為時過早，但只是按管道劃分，一些定價動態可能會是什麼樣子。

And then I have a follow-up.

然後我有一個後續行動。

Go ahead John T.

繼續吧，約翰·T。

This is really important so far about what is happening this year versus what is happening next year with Sanofi, right.

到目前為止，這對於賽諾菲今年發生的事情和明年發生的事情來說確實很重要，對吧。

Of course, this partnership is strategically very beneficial to us.

當然，這種夥伴關係在策略上對我們非常有利。

We're not seeing the benefit yet of that relationship and we're beginning through all the transition activities.

我們還沒有看到這種關係的好處，我們正在開始進行所有的過渡活動。

There's a high level of cooperation and collaboration across all markets.

所有市場之間都存在著高水準的合作與協作。

And so therefore, what we expect to see happening as they fully embrace the relationship next year is the depth and strength of their marketing capabilities globally, US, Europe across the globe.

因此，當他們明年完全接受這種關係時，我們預計會看到他們在全球、美國、歐洲的行銷能力的深度和實力。

But also remember how deeply penetrated they are in the vaccine space, including influenza, having a COVID vaccine available alongside of their flu vaccines should have a dramatic impact in overall demand.

但也要記住，他們在疫苗領域（包括流感）的滲透程度有多深，將新冠疫苗與流感疫苗一起使用應該會對整體需求產生巨大影響。

So we see significant progress being made as we go into the '25, '26 season.

因此，當我們進入 25、26 賽季時，我們看到正在取得重大進展。

Understood.

明白了。

And then on the spend structure, quickly, how are you thinking steady state in this 2026, '27 time frame, knowing you may not have a commercial infrastructure then and may not look to perhaps even do a large-scale Phase 3 program beyond obviously, this Phase 3 CIC program that you're executing?

然後在支出結構上，很快，您如何看待 2026 年、27 年時間框架內的穩定狀態，知道您當時可能沒有商業基礎設施，並且可能不希望進行大規模的第三階段計劃，顯然超出，您正在執行的第3 階段CIC 計劃？

So I think to make sure I understand your question correctly is a commercial infrastructure to support any other future development activities.

因此，我認為確保我正確理解你的問題是支持任何其他未來開發活動的商業基礎設施。

If that's the question, I think what we're primarily looking at is partnering some of these late-stage assets, right, and not having the significant cost infrastructure to support a commercial organization going forward.

如果這是問題所在，我認為我們主要關注的是與其中一些後期資產進行合作，對吧，並且沒有大量的成本基礎設施來支持商業組織的未來。

And we would see the benefit of partnering out these assets going forward, which is exactly what we did with Sanofi and what we potentially do with our own CIC program going forward.

我們將看到未來與這些資產合作的好處，這正是我們與賽諾菲所做的，以及我們未來可能對我們自己的 CIC 計畫所做的。

And Mayank, if you kind of look back at some of the prepared remarks I provided earlier, one of the things you're going to see, I noted is this quarter, we had approximately $30 million in spend related to commercial and, call it, field based medical affairs activities.

Mayank，如果你回顧我之前提供的一些準備好的評論，你會看到的一件事，我指出的是本季度，我們有大約 3000 萬美元與商業相關的支出，稱之為、實地醫療事務活動。

So it annualized to about $120 million that we don't expect and anticipate spending in future years.

因此，按年計算，我們預計並預計未來幾年的支出約為 1.2 億美元。

And that is part of the reason why we've got significant confidence in our ability to continue to decrease our run rate on R&D and SG&A in line with the guidance we've been providing.

這就是為什麼我們對自己有能力按照我們一直提供的指導繼續降低研發和銷售管理費用運作率充滿信心的部分原因。

Understood.

明白了。

And lastly, on your next IND filing coming from Bob and Ruxandra, I know you talked about a number of pipeline initiatives.

最後，在 Bob 和 Ruxandra 提交的下一份 IND 申請中，我知道您談到了一些管道計劃。

Just maybe if you've narrowed down on what could be the next IND filing for one of your prioritized programs?

如果您已經縮小了優先項目之一的下一個 IND 申請範圍，也許會怎麼樣？

And in the same context, if you are able to talk to also Sanofi's prioritization of any next candidate beyond the Nuvaxovid would also be helpful.

在同樣的背景下，如果您能夠與賽諾菲討論 Nuvaxovid 之外的任何下一個候選藥物的優先順序也會有所幫助。

Thanks again for taking the questions.

再次感謝您提出問題。

Bob, do you want to take the question on thoughts around our next IND and how we're approaching that process?

鮑勃，您想回答有關我們下一個 IND 的想法以及我們如何處理該流程的問題嗎？

Yeah, sure.

是的，當然。

As I mentioned in the R&D strategy going forward, we do have two candidates right now that are moving toward IND and in or soon to begin IND enabling activities.

正如我在未來的研發策略中提到的，我們現在確實有兩個候選人正在邁向 IND 並正在或即將開始 IND 支援活動。

And so that's the RSV combination program as well as the pandemic influenza.

這就是 RSV 組合計劃以及大流行性流感。

So too soon, I think, to give you anything more specific in terms of timing.

我認為現在給大家更具體的時間安排還為時過早。

But those are the two that I think I would regard as being next in line.

但我認為這兩個是我認為的下一個。

And then the other areas that we talked about, we'll be able to give you more clarity in the months ahead.

然後我們討論的其他領域，我們將能夠在未來幾個月為您提供更清晰的資訊。

But yeah, okay, I think that answers your question.

但是，是的，好吧，我想這回答了你的問題。

Let me know.

讓我知道。

Thank you, Bob.

謝謝你，鮑伯。

And Mayank, you asked a second question about Sanofi.

Mayank，你問了關於賽諾菲的第二個問題。

Obviously, in their most recent earnings call, they noted they're preparing to initiate a Phase 1, 2 CIC study this year and with a positive readout.

顯然，在最近的財報電話會議中，他們指出，他們正準備在今年啟動第一、第二階段的 CIC 研究，並取得了積極的結果。

If they get that positive readout, they would move towards a Phase 3 sometime in 2025.

如果他們得到積極的結果，他們將在 2025 年的某個時候進入第三階段。

You can go check their commentary to clarify that for your notes.

你可以去查看他們的評論來澄清你的筆記。

And then we can't comment on any other things that Sanofi may be working on right now.

然後我們無法評論賽諾菲目前可能正在研究的任何其他事情。

But I think just referring everyone back to that contract and the agreement that we have where there are multiple opportunities to partner with Sanofi on our Matrix-M adjuvant and they can also make that their choosing multiple combinations with our COVID vaccine should they choose to do so.

但我認為，只要讓大家回顧一下我們的合約和協議，其中就有多種機會與賽諾菲就我們的Matrix-M 佐劑進行合作，如果他們選擇這樣做，他們也可以選擇與我們的COVID疫苗進行多種組合所以。

Each new asset they would develop with Matrix-M has towards $200 million in potential onetime milestone payments and ongoing royalties for years to come.

他們與 Matrix-M 合作開發的每項新資產都有可能獲得 2 億美元的一次性里程碑付款和未來幾年的持續特許權使用費。

So certainly a lot of opportunity in that contract over time to develop multiple assets should they choose to take that pathway.

因此，如果他們選擇走這條路，隨著時間的推移，該合約肯定有很多機會開發多種資產。

You'll have to look to them for further commentary on their plans.

您必須向他們尋求對其計劃的進一步評論。

Noted.

著名的。

Thanks for that.

謝謝你。

Helpful color and congrats on the progress.

有用的顏色，祝賀取得的進展。

Thank you, Mike.

謝謝你，麥克。

Alec Stranahan, Bank of America.

亞歷克·斯特拉納漢，美國銀行。

Hi guys, Matthew on for Alec here.

大家好，馬修為亞歷克發言。

Thanks for taking the question and congrats on the quarter.

感謝您提出問題並祝賀本季。

Just two quick ones from us.

我們只有兩個快的。

Curious if you can provide some color on the net price for Nuvaxovid this year and how much of that channel was outside of retail and whether you expect that to be similar going forward in the future years?

好奇您能否提供一些有關 Nuvaxovid 今年淨價的信息，以及該渠道有多少是在零售之外的，以及您是否預計未來幾年也會出現類似情況？

Sorry, if you could just restate the question real quick, sorry.

抱歉，如果您能快速重述這個問題，抱歉。

Yeah.

是的。

Just looking for some color on the net price for Nuvaxovid this year and how much of that was outside of retail and whether you expect those dynamics to continue in the upcoming years?

只是想了解一下 Nuvaxovid 今年的淨價，其中有多少是零售以外的，以及您是否預計這些動態在未來幾年會持續下去？

Yeah, go ahead, John.

是的，繼續吧，約翰。

Excellent.

出色的。

Happy to address the net price question.

很高興解決淨價問題。

While we have not given a specific net price, some of the feedback that I've shared more generally about this marketplace has been the following.

雖然我們沒有給出具體的淨價，但我更廣泛地分享的有關該市場的一些反饋如下。

All three COVID vaccines on a gross basis are approximately the same around

所有三種新冠疫苗的總量大致相同

[140 per dose. It is reasonable to assume that the net price after deductions would be in the 50% to 75% of gross that would put you at 70 to 100].

[每劑 140。可以合理地假設扣除後的淨價將佔總價的 50% 到 75%，這將使您的價格達到 70 到 100]。

And then in addition to that, depending on the dynamics of returns at any given time, hey, that number can fluctuate.

除此之外，根據任何給定時間的回報動態，嘿，這個數字可能會波動。

But I think that does give you, hopefully, a sort of generalized view.

但我認為這確實能為你帶來一種普遍的觀點。

And then with respect to the retail versus non-retail, I'll let John comment on market dynamics last year and what we're seeing this year as well.

然後，關於零售與非零售，我將讓約翰評論去年的市場動態以及我們今年所看到的情況。

Yeah.

是的。

And let me just follow up just a point of clarification on a previous question, right?

讓我對之前的問題做個澄清，對嗎？

So while we're looking at IQVIA data, and there are multiple sources of shots and arms data and also there's what's revenue generating out to the distributor versus what actual shots and arms are.

因此，當我們查看 IQVIA 資料時，鏡頭和武器資料有多個來源，而且經銷商所產生的收入與實際鏡頭和武器的資料也有關係。

The clarification, I said 800,000 doses before, the actual number is closer to 500,000 doses with the one week lag simply coming off of the IQVIA data.

澄清一下，我之前說過 80 萬劑，實際數量接近 50 萬劑，只是 IQVIA 數據有一週的延遲。

So a lot of data points here.

這裡有很多數據點。

I think where the updated guidance is considering all of the trends, what we're seeing in the market so far, but just to be crystal clear and specific about what the IQVIA data is reporting so far.

我認為更新後的指導意見考慮了所有趨勢、我們迄今為止在市場上看到的情況，但只是為了清楚、具體地說明 IQVIA 數據迄今為止報告的內容。

Operator next question?

運營商下一個問題？

Eric Joseph, JP Morgan.

艾瑞克‧約瑟夫，摩根大通。

On the Phase 3 CIC trial.

關於第三階段 CIC 試驗。

Your prior guidance was for an expected readout in the mid '25 time frame.

您之前的指導是在 25 年中期的預期讀數。

Is that still your expectation?

這還是你的期望嗎？

Or should we be carrying a more conservative timeline assumption perhaps in the second half?

或者我們應該在下半年採取更保守的時間表假設？

And just kind of having gone through this clinical hold experience, I wonder to what extent your Phase 3 IND might be exposed to any additional longer term follow-up from the Phase 2 trial?

經歷過這種臨床擱置經驗後，我想知道您的 3 期 IND 在多大程度上可能會受到 2 期試驗的任何額外長期追蹤？

Have you reviewed any potential at risk patients to rule out the potential for similar SAE type of events?

您是否對任何潛在的高風險患者進行了檢查，以排除發生類似 SAE 類型事件的可能性？

And then finally, just when it relates to the stand-alone flu portion of the Phase 3 study, I just want to confirm whether that the design is intended to support registration of this flu stand-alone?

最後，當涉及到第三階段研究的獨立流感部分時，我只想確認該設計是否旨在支持該流感獨立的註冊？

And if so, whether you have superior immunogenicity in mind there via the trial design or if it's more around a non-inferior signal?

如果是這樣，您是否透過試驗設計考慮到了優越的免疫原性，或者是否更多地圍繞非劣質信號？

Thanks for taking the questions.

感謝您提出問題。

Thank you for your questions, Eric.

謝謝你的提問，艾瑞克。

I think you had three questions into the questionnaire, but very good points.

我認為您在問卷中提出了三個問題，但都非常好。

So number one, on timing.

所以第一，時間。

We did address that a little earlier.

我們確實早些時候解決了這個問題。

Let me just reframe that so everyone is clear that we were on track in Q4, as we stated before to initiate our trial and then the clinical hold occurred.

讓我重新表述一下，以便每個人都清楚我們在第四季度步入正軌，正如我們之前所說的啟動試驗，然後發生了臨床擱置。

We're happy that, that was lifted in a short order.

我們很高興這一問題在短時間內得到了解除。

And now we're gearing up to reinitiate that trial.

現在我們正準備重新啟動這項試驗。

So we just got the feedback from FDA on Friday, close of business or so, worked on it over the weekend and yesterday.

因此，我們在周五營業時間結束左右才收到 FDA 的反饋，並在周末和昨天進行了處理。

So we're not going to commit to a precise timing to restart that trial or to start that trial now, I should say.

因此，我應該說，我們不會承諾重新啟動該試驗或現在開始該試驗的精確時間。

But give us in the near term, another couple of weeks or so, we'll be able to provide more clarity on trial start timing.

但在短期內，再過幾週左右，我們將能夠更明確地提供試驗開始時間。

But we don't see a significant delay, we think we can get it started relatively in the near term.

但我們沒有看到明顯的延遲，我們認為我們可以在短期內相對啟動它。

But again, we'll clarify once we finish working through FDA feedback.

但再次強調，一旦我們完成 FDA 回饋的工作，我們將澄清。

So thanks for that question.

謝謝你提出這個問題。

Bob, do you want to take the other two questions that Eric had.

鮑勃，你想回答艾瑞克提出的另外兩個問題嗎？

Thank you.

謝謝。

Sure.

當然。

So the follow-up on the trial is the standard length of safety monitoring for adjuvanted vaccines and I think I'll just leave it there.

因此，試驗的後續內容是佐劑疫苗安全監測的標準長度，我想我就會將其留在那裡。

In terms of the design for the Phase 3 and the flu stand-alone product, similar to CIC, the intent of the study is to demonstrate non-inferior immunogenicity.

就3期和流感獨立產品的設計而言，與CIC類似，研究的目的是證明非劣效的免疫原性。

So that's true for the CIC product, and that's equally true for our flu stand-alone.

對於 CIC 產品來說是這樣，對於我們的流感獨立產品也是如此。

The study will be able to obviously generate more than non-inferiority data.

顯然，這項研究將能夠產生比非劣效性數據更多的數據。

So the statistical analysis has the ability to demonstrate superiority, but the study is designed and powered for non-inferiority.

因此，統計分析有能力證明其優越性，但研究的設計和動力是為了非劣效性。

So I hope that's clear.

所以我希望這是清楚的。

I think Eric was also asking, if we heard your question correctly, is that designed for registration in that trial, Bob. could it provide a registrational opportunity?

我認為艾瑞克也在問，如果我們正確地聽到了你的問題，那是為了在該試驗中註冊而設計的，鮑伯。它可以提供註冊機會嗎？

Yeah, absolutely.

是的，絕對是。

This study is designed as a Phase 3a immunogenicity trial to support a licensure of the products with the understanding that a follow-on clinical efficacy trial would need to be demonstrated post approval.

這項研究被設計為 3a 期免疫原性試驗，以支持產品的許可，但需要在批准後證明後續臨床療效試驗。

And again, that whether or not it can be will be determined by the FDA in their overall oversight based on the data and other factors, Bob, correct?

再說一次，是否可以，將由 FDA 根據數據和其他因素進行整體監督來決定，鮑勃，對嗎？

That's right.

這是正確的。

Excellent.

出色的。

Well, thank you very much for taking the questions.

好的，非常感謝您提出問題。

Brendan Smith, TD Cowen.

布倫丹·史密斯，TD·考恩。

Hi, this is Jackie on for Brendan.

大家好，我是布蘭登的傑基。

Maybe just one on your expectations for your analyst event next year.

也許只是您對明年分析師活動的期望。

Will you confirm any new pipeline programs?

您是否會確認任何新的管道計劃？

And are you planning to be in the clinic with any other wholly owned assets besides the flu in the next 18 months?

您是否計劃在未來 18 個月內將流感以外的其他全資資產投入診所？

Jim Kelly, do you want to take the Analyst Day?

吉姆凱利，你想參加分析師日嗎？

Yeah, certainly, and thanks for the question, and as we evolve into the post-commercial version of Novavax, we're really looking forward to unveil more and more of our thinking on not just R&D, but all four pillars.

是的，當然，感謝您提出這個問題，隨著我們進入 Novavax 的後商業版本，我們真的很期待不僅在研發方面，而且在所有四個支柱方面公佈越來越多的想法。

Our anticipation of how this will unfold is you can expect more updates from us between now and our earnings for the fourth quarter, which would be at the end of February.

我們對這將如何展開的預期是，從現在到我們第四季（即二月底）的收益，您可以期待我們提供更多更新。

And then we think we'd be best positioned to do something like an Investor Day after that time and at some point in 2025.

然後我們認為，在那之後以及 2025 年的某個時候，我們最適合舉辦投資者日之類的活動。

So that's our thinking, we expect to hear more of our thinking unfold as the coming months go by.

這就是我們的想法，我們希望在接下來的幾個月裡聽到更多我們的想法。

We're really excited to have Ruxandra here and everything she's going to bring to our very thoughtful and disciplined approach to advancing our investments in our technology.

我們非常高興 Ruxandra 來到這裡，以及她將為我們以深思熟慮和嚴格的方法推進我們的技術投資帶來的一切。

Great.

偉大的。

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

Vernon Bernardino, HC Wainwright.

弗農·伯納迪諾，HC 溫賴特。

Hi, thank for taking my questions, actually, I have two questions.

您好，感謝您回答我的問題，實際上，我有兩個問題。

Excuse me -- the first question I had, there's some evidence that the flu vaccine this year was not as good as in prior years.

對不起，我的第一個問題是，有一些證據顯示今年的流感疫苗不如往年。

Just wondering how the CIC vaccine formulation for the flu vaccine component is handling that?

只是想知道流感疫苗成分的 CIC 疫苗配方是如何處理這個問題的？

The second question I have is, just wondering if you could provide us insight into how the gross margins may change going forward.

我的第二個問題是，只是想知道您是否能為我們提供有關毛利率未來可能如何變化的見解。

Thank you.

謝謝。

Bob, do you want to take Vernon's first question?

鮑勃，你想回答佛農的第一個問題嗎？

So the strains that we are planning to use in the Phase 3a trial are the US or Northern Hemisphere strains for the last season, for the season that we're currently in.

因此，我們計劃在 3a 階段試驗中使用的菌株是上個季節以及我們目前所處季節的美國或北半球菌株。

And again, just to remind you, the trial is not designed as a clinical efficacy trial, but is a comparative immunogenicity study, right.

再次提醒您，該試驗並不是作為臨床療效試驗而設計的，而是一項比較免疫原性研究，對吧。

So the readout is going to be whether or not the immune responses induced by the flu component in our vaccine are not inferior to the immunogenicity of the competitor flu vaccine.

因此，讀數將是我們疫苗中流感成分誘發的免疫反應是否不遜於競爭對手流感疫苗的免疫原性。

And in good efficacy years or less good efficacy years, the immunogenicity is a kind of a stand-alone readout, that's going to be driving the analysis of this study.

在療效良好或療效不佳的年份，免疫原性是一種獨立的讀數，這將推動本研究的分析。

(multiple speakers)

（多個發言者）

Vernon, happy to answer the question about gross margins in 2025 and forward.

Vernon，很高興回答有關 2025 年及以後毛利率的問題。

This year is our last commercial year, certainly in US markets, Europe.

今年是我們最後一個商業年，尤其是在美國市場和歐洲。

We had noted that while there's some trailing APAs, we're excluding them from our future guidance at this time.

我們注意到，雖然有一些後續預約定價安排，但我們目前將它們排除在我們未來的指導之外。

So I'll focus my comments on what will be our cost of goods sold for '25, '26 and beyond.

因此，我的評論重點是 25 年、26 年及以後的銷售成本。

It is going to reflect providing supply to Sanofi for 2025 and 2026, that's on a cost-plus basis.

它將反映 2025 年和 2026 年向賽諾菲提供的供應量，這是基於成本加成的基礎上的。

And so you can see that the traditional commercial company relevance of gross margin is not going to be the same from '25 forward.

因此，您可以看到，從 25 年開始，傳統商業公司的毛利率相關性將不再相同。

That's going to be a more cost plus.

這將是更多的成本加成。

This concludes the question and answer session.

問答環節到此結束。

I would now like to turn the conference back to John Jacobs for any closing remarks.

現在我想請約翰·雅各布斯（John Jacobs）發表閉幕詞。

(Operator Instructions)

（操作員說明）

I will now turn the conference back over to John Jacobs for any closing remarks.

現在我將把會議轉回約翰·雅各布斯發表閉幕詞。

Please go ahead.

請繼續。

Thank you everyone for joining us today.

感謝大家今天加入我們。

Appreciate it.

欣賞它。

Looks like someone pressed the wrong button on the phone call.

看來有人在通話時按錯了按鈕。

So we're formally closing the call here.

我們在此正式結束通話。

Really appreciate you all joining us today.

非常感謝大家今天加入我們。

Thank you very much.

非常感謝。

The conference has now concluded.

會議現已結束。

Thank you for attending today's presentation, you may now disconnect.

感謝您參加今天的演示，您現在可以斷開連接。