Novavax 召開電話會議,討論 2024 年第三季財務表現與營運亮點。他們概述了一項新的企業成長策略,重點關注業務發展和研發,包括與賽諾菲的合作夥伴關係。該公司對其新冠疫苗計劃的進展感到滿意,並將商業領導權移交給賽諾菲。
Novavax 宣布本季總營收為 8,500 萬美元,專注於提高財務實力和業績。他們也正在探索傳染病領域的機會,並有可能擴展到治療領域。此次電話會議包括有關研發計劃、財務業績和未來計劃的最新信息,其中包括 2025 年的投資者日。
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
Unidentified_1
Unidentified_1
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。
All participants will be in listen-only mode.
所有參與者將處於僅聽模式。
Should you need assistance?
您需要協助嗎?
Please signal a conference specialist by pressing the star key followed by zero.
請按星號鍵,然後按零,向會議專家發出訊號。
After today's presentation, there will be an opportunity to ask questions to ask the questions.
今天的演講結束後,將有機會提問。
You may, you may press star followed by the one on your touchtone phone to withdraw your question.
您可以按星號,然後按按鍵式電話上的星號來撤回您的問題。
Please press star followed by the two.
請按星號,然後按兩個。
Please note this event is being recorded.
請注意此事件正在被記錄。
I would now like to turn the conference over to Louis de Vice President, investor relations.
現在我想將會議交給負責投資人關係的副總裁 Louis de 主持。
Please go ahead.
請繼續。
Unidentified_2
Unidentified_2
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 dotcom and an audio archive of this conference call will be available on our website later today.
目前,我們的網站 Novavax dotcom 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.
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 公司策略和營運計畫相關的陳述。
Its value drivers and near term priorities.
其價值驅動因素和近期優先事項。
Its partnerships and expectations with respect to potential royalties, milestones and cost reimbursements.
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。
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.
其對 COVID 19 疫苗的製造能力、時間安排、生產和交付、Novavax 臨床和臨床前候選產品開發 2024 年全年財務指導以及 Novavax 未來財務或業務績效的期望。
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.
有關這些因素的更多資訊出現在我們今天早上發布的簡報中有關前瞻性陳述的警告標題和風險因素標題下。
In our most recent form, 10-K and subsequent form, 10 QS filed with the Securities and Exchange Commission available at sec.gov and our website at novavax dotcom.
在我們向美國證券交易委員會提交的最新表格 10-K 和後續表格中,可在 sec.gov 和我們的網站 novavax dotcom 上取得 10 QS。
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 nongaap financial measure which is forward-looking information for combined R&D and SGNA 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研發和 SGNA 合併費用的前瞻性資訊。
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 Reino, 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 Reino 將提供有關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。
Unidentified_3
Unidentified_3
Thank you, Lewis and thank you everyone for joining us.
謝謝劉易斯,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.
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。
All while reshaping the company into a leaner and more agile organization.
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,轉而轉向創造額外價值的活動,我們今天將詳細討論這一點。
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.
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。
And our next steps on each, the four value drivers are value driver, one, the Sanofi partnership, value driver.
我們接下來的步驟是,四個價值驅動因素是價值驅動因素,一是賽諾菲合作關係,價值驅動因素。
Two, our late stage pipeline kick and flu value driver.
第二,我們的後期管道啟動和流感價值驅動因素。
Three, leveraging our proven technology platform to drive additional partnerships and deals and value driver.
第三,利用我們成熟的科技平台來推動更多的合作關係、交易和價值驅動力。
Four are emerging early stage pipeline.
其中四個正在新興的早期管道中。
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之上,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 as we discussed last quarter, the partnership with Sanofi is a license and collaboration agreement that combines Novavax's proprietary protein and nanoparticle technologies.
首先,我們來談談價值驅動因素之一,即我們上季度討論的賽諾菲合作夥伴關係,與賽諾菲的合作夥伴關係是一項許可和合作協議,結合了Novavax 專有的蛋白質和奈米顆粒技術。
Matrix adjuvant and our R&D expertise with Sanofi's world class leadership in launching and commercializing innovative vaccines.
基質佐劑和我們的研發專業知識以及賽諾菲在創新疫苗推出和商業化方面的世界級領導地位。
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.
賽諾菲將從 2025 年開始主導我們的 COVID 19 疫苗的聯合商業化,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.
我們還有可能透過賽諾菲開發的其他疫苗與我們現有的 COVID 19 產品結合或使用我們的 Matrix M 佐劑產生多種額外的收入來源,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 Novovax.
作為提醒,我們在第二季度收到了 5 億美元的首期現金付款以及 Novovax 約 7000 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 zone combination COVID flu vaccine.
我們還有資格獲得與我們的 COVID 19 疫苗和賽諾菲區域組合 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.
以及未來的里程碑付款和特許權使用費。
We anticipate from these programs.
我們對這些計劃的預期。
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.
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中獲得額外的特許權使用費和/或里程碑。
As you can see, Sanofis 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.
正如您所看到的,賽諾菲斯在疫苗開發和商業化方面擁有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,可以在未來幾年推動巨大價值。
Both for our shareholders and the people who would have broadened access to our vaccine technology and the protection it can provide.
對於我們的股東和那些希望擴大我們的疫苗技術及其所能提供的保護的人來說都是如此。
Our second value.
我們的第二個價值。
Driver is Novavax's late stage pipeline.
Driver是Novavax的後期管道。
Our late stage pipeline is comprised of our COVID 19 influenza combination and standalone influenza vaccine candidates.
我們的後期產品線包括 COVID 19 流感組合疫苗和獨立的候選流感疫苗。
We believe that combination vaccines such as our KIC 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 KIC 候選藥物這樣的聯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 standalone 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劃是基於一個在後期試驗中已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.
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蛋白佐劑的流感疫苗。
And one which can serve as the foundation to advance an innovative and differentiated pandemic influenza program, as well as we previously communicated.
正如我們之前所傳達的那樣,它可以作為推進創新和差異化大流行性流感計畫的基礎。
Our intention is to partner these assets.
我們的目的是與這些資產合作。
Dr Bob Walker will provide updates on this program shortly and now moving on to value driver three, which is to leverage our proven technology platform to drive additional partnerships and deals 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.
Bob Walker 博士將很快提供有關該計劃的最新信息,現在將討論第三個價值驅動因素,即利用我們經過驗證的技術平台來推動更多合作夥伴關係和交易,我們經過驗證的技術平台由我們的基質M 佐劑和我們的基於奈米顆粒蛋白質的技術組成,我們相信這為我們提供了與一系列疫苗領域的多種潛在合作夥伴一起獲得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 last quarter.
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(正如我們在已上市的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的現有疫苗,或使他們能夠使用我們的佐劑開發新疫苗上個季度。
We shared data from existing vaccines combined with Matrix M to demonstrate how our adjuvant can be leveraged to potentially improve them.
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 adjuvent could provide to the existing vaccine portfolios of other companies.
我們展示的用我們的基質 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。
And we continue to explore other ways to leverage its potential and finally value driver for our emerging early stage pipeline.
我們將繼續探索其他方法來利用其潛力並最終為我們新興的早期管道提供價值驅動力。
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看到最未滿足的醫療需求和我們的技術最大潛力的其他領域。
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.
這將包括科學性、基本原理以及相信我們的技術能夠在特定治療領域、市場機會和未滿足的醫療需求水平方面脫穎而出並獲勝的理由等考慮因素。
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.
新興的競爭管道、資產對其他公司的吸引力以及合作的能力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.
重要的是,我們打算以資本有效的方式執行這項策略。
One that maintains our flexibility and preserves the potential for maximum value creation.
一種保持我們的靈活性並保留創造最大價值的潛力的方法。
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 for the remainder of this year.
總而言之,我們的企業成長策略將我們的所有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,並在今年剩餘時間裡以更加精簡和高效的組織來實現這一目標。
And in line with our key value drivers, we're focused on executing our four priorities which you will see on slide, six priority one, the successful execution of our partnership with Sanofi priority two, driving incremental value from our technology platform with the advancement of our kick and flu programs, the ongoing development of an emerging early stage pipeline and pursuing new business development opportunities.
根據我們的關鍵價值驅動因素,我們專注於執行您將在幻燈片中看到的四個優先事項,其中六個優先事項一,成功執行我們與賽諾菲的合作夥伴關係,第二,隨著進步推動我們技術平台的增量價值我們的踢球和流感項目、新興早期管道的持續開發以及尋求新的業務發展機會。
Priority three further reduction of our R&D and SG and a costs in line with our guidance along with implementing additional reductions to scale as we enter 2025 and beyond and priority for delivery of our updated COVID 19 vaccine for the 2,425 vaccination season.
優先事項三是進一步減少我們的研發和SG以及符合我們指導的成本,同時在進入2025年及以後實施額外的規模削減,並優先為2,425個疫苗接種季節提供更新的COVID 19疫苗。
Before I hand the call over to additional members of our team.
在我將電話轉交給我們團隊的其他成員之前。
I want to take a moment to welcome Dr Raex Sandra drag our new head of R&D who started just yesterday.
我想花一點時間歡迎 Raex Sandra 博士,我們昨天剛上任的新任研發主管。
Rexana 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.
Rexana 為 Novavax 帶來了 20 多年來廣泛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 Alexandra in the coming weeks as she settles into her new role.
在接下來的幾週內,隨著亞歷珊卓適應新角色,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 Trezzo 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 John Trezzo,以了解我們的營運最新情況。
John.
約翰.
Unidentified_4
Unidentified_4
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 2,425 season.
我們對 2,425 季節第一階段的新冠疫苗計劃的進展感到高興。
And with this progress, we are already seeing that season to date.
隨著這一進展,我們已經看到了那個賽季的進展。
Novavax's vaccine administrations in the US already outperform those done in the entire 2,324 season with our current weekly market share averaging about 3%.
Novavax 在美國的疫苗管理已經優於整個 2,324 季的疫苗管理,我們目前每週的市佔率平均約為 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 New Vaccinid in the 2,526 season, please turn to slide 8.
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 2,526 季節接管新疫苗商業化的主導地位時取得成功,請轉向幻燈片 8。
Our primary commercial efforts remain dedicated to the largest market opportunity.
我們的主要商業努力仍然致力於最大的市場機會。
The US, we initiated our 2,425 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 compared to last season.
在美國,我們在實現我們的目標後不久就啟動了 2,425 個 COVID 19 商業季節,即與競爭對手的時間一致,在 8 月底獲得疫苗授權,以便與上個季節相比能夠及時開始季節。
This was a significant improvement in timing for Novovax.
這對 Novovax 來說是一個重大的改進。
At the same time, the current COVID 19 vaccine season initiated three weeks earlier in the US as compared to last season.
同時,美國目前的 COVID 19 疫苗季節比上一季提前了三週。
And we believe that if current trends continue, the total market size could be approximately 40 to 50 million shots in arms this season.
我們相信,如果目前的趨勢持續下去,本季的總市場規模可能約為 4,000 至 5,000 萬支槍。
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 no vaccinated available in over 30,000 locations including CVS Pharmacy Rite aid, Walgreens, Meyer, 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,更廣泛的獲取和改進的合同,將30,000 多個地點中沒有疫苗接種的地點數量增加了一倍,其中包括CVS Pharmacy Rite援助、沃爾格林、邁耶以及數百家其他雜貨店和數千家獨立藥局。
Higher visibility of novovax 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.
novovax 在大多數主要零售商的疫苗調度程序中的知名度更高,並採取有針對性的商業方法,執行行銷和銷售活動,針對特定的機會市場,而不是去年更廣泛的全國性方法。
Please turn to slide 9 in situations with more favorable market access contracts.
請參閱投影片 9 以了解有更優惠的市場進入合約的情況。
Novavax is demonstrating the ability to compete with the MRNA vaccines in one regional supplier of vaccinations.
Novavax 正在展示與一家區域疫苗供應商的 mRNA 疫苗競爭的能力。
Novavax has achieved approximately 70% market share as reported by that retailer.
根據該零售商報告,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 Novax claims are in our primary target audience of 65 plus.
迄今為止,我們發現 53% 的 Novax 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 Aci's recent recommendation for this age cohort to revaccinate this season.
值得注意的是,這些受眾群體與 Aci 最近針對該年齡層在本季重新接種疫苗的建議是一致的。
After their initial updated seasonal dose.
在最初更新季節性劑量後。
At the same time, we experienced some challenges that have prevented us from achieving our initial market share goals.
同時,我們也遇到了一些挑戰,阻礙我們實現最初的市佔率目標。
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 dating for our prefilled syringe, which we intend to work with the FDA to improve for future seasons.
即Mrna 疫苗的最低採購承諾合約、我們疫苗的有限初始零售庫存、有限的商業基礎設施(僅為我們之前規模的30%)以及我們的預充注射器的三個月產品日期,我們打算與FDA 合作改善這些基礎設施未來的季節。
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,但我們不認為我們目前的市場份額能夠代表我們的 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.
事實上,有超過 30,000 個零售店庫存我們的疫苗。
We have seen an increase in the level of restocking quantities demonstrating growing demand 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, we continue to work closely with our partner to enable a seamless transition of lead commercial activities.
我們看到補貨數量的增加表明,隨著本季剩餘時間的推進,需求不斷增長,我們相信這些努力將繼續加強機會,並為賽諾菲為下一季做好準備奠定堅實的基礎,我們將繼續與我們的合作夥伴密切合作,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 Novex 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 Novex COVID 19 疫苗不斷增長的需求,將導致該產品在即將到來的季節取得成功。
Please turn to slide 10 outside of the US.
美國境外請參閱投影片 10。
We were pleased to receive marketing authorization for our updated vaccine from the European Commission last month, 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 2,526 season in other regions.
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,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,讓他們接管領先的商業季節其他地區的營運量為 2,526 季。
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.
正如我們過去所指出的,我們將繼續優先完成 APAS,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 Santa Fe with its large commercial reach and greater resources will drive additional market share in 2025.
總之,我們認為對 COVID 19 疫苗的需求仍然持續,並相信聖達菲憑藉其巨大的商業影響力和更多的資源將在 2025 年推動更多的市場份額。
And beyond.
甚至更遠。
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。
Unidentified_5
Unidentified_5
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.
今天,我將詳細闡述我們的研發計劃的重要更新,這些更新支持四個關鍵價值驅動因素。
John Jacobs outlined earlier.
約翰·雅各布斯之前曾概述過。
I'll start with our updated 2024 25 COVID 19 vaccine followed by our late stage program in KIC and influenza.
我將從我們更新的 2024 年 25 COVID 19 疫苗開始,然後是 KIC 和流感的後期計劃。
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.
然後我將討論擴大矩陣 M 的潛在機會,並以我們內部臨床前管道和未來研發策略的最新情況作為總結。
Please turn to slide 13 with regard to our 2024 25 COVID 19 vaccine targeting the JN one strain.
請參閱投影片 13,以了解我們針對 JN 一株的 2024 25 COVID 19 疫苗。
We continue to monitor the performance of our vaccine against newly circulating variants in nonclinical 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 311 and XCC.
這些數據繼續證明了對每種新菌株(包括 KP 311 和 XCC)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 one vaccine in Rhesus.
這張幻燈片顯示了在恒河猴中接受我們的 JN one 疫苗前後的中和抗體反應。
M.
M。
You can see that the antibody titers are robust against all of the variants tested including the KP 311 and XEC variants that are now widely circulating.
您可以看到,抗體滴度針對所有測試的變體(包括目前廣泛傳播的 KP 311 和 XEC 變體)均表現強勁。
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 kick 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 流感組合或踢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 KIC and standalone 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 KIC 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 two 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 詳細審查了我們第二階段研究的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 three immunogenicity trial as soon as possible.
我們打算盡快開始招募我們的第三期免疫原性試驗。
Please turn to slide 16 data from our now completed phase two kick study support noninferior immunogenicity of both our KIC and influenza vaccines.
請參閱幻燈片 16,我們現已完成的第二階段踢研究數據支持我們的 KIC 和流感疫苗的非劣性免疫原性。
During the phase three pre ID process, the FDA and Novovax aligned on a single phase three trial for both candidates with an updated trial design as shown in the graphic on the right.
在第三階段預 ID 過程中,FDA 和 Novovax 為兩名候選人進行了一項第三階段試驗,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 noninferiority for KIC will be made to the Nova Novavax's COVID 19 vaccine and to an age recommended commercial influenza vaccine immunologic comparisons to establish noninferiority for Novavax's seasonal influenza vaccine will also be made to the same commercial flu vaccine.
參與者將被隨機分配到四個疫苗組之一,並將與Nova Novax 的COVID 19 疫苗進行免疫學比較,以確定KIC 的非劣效性,還將與建議年齡的商業流感疫苗進行免疫學比較,以確定Novavax 的季節性流感疫苗的非劣效性相同的商業流感疫苗。
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 on prior earnings calls we presented data supporting each of the matrix M attributes listed on this slide.
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矩陣M 的屬性,我們認為,在之前的財報電話會議上,我們提供了支持以下各項的數據,這些屬性可能會對已建立或開發疫苗特許經營權的合作夥伴產生重大興趣該投影片上列出的矩陣 M 屬性。
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.
我們相信這些屬性為基質 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。
And we previously shared those data while maintaining excellent tolerability.
我們之前共享了這些數據,同時保持了出色的耐受性。
And we believe matrix M has the potential to be antigen sparing and reduce cost of production such as for pneumococcal polysaccharide vaccines.
我們相信基質 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。
And we previously shared those data as well.
我們之前也共享過這些數據。
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.
我們也相信,Matrix M 可能有助於針對某些免疫原性較差的病原體開發新疫苗,這些病原體尚未被視為良好的候選疫苗。
To date.
迄今為止。
During the third quarter, Novovax entered into a material transfer agreement with a leading pharmaceutical company to evaluate Matrix M in a bacterial vaccine program.
第三季度,Novoax 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 and proven adjuvant activity and impressive safety profile which includes its role as a component of two authorized vaccines.
我們打算繼續尋找類似的機會,以進一步利用基質和經過驗證的佐劑活性以及令人印象深刻的安全性,其中包括其作為兩種授權疫苗的組成部分的作用。
Our COVID 19 vaccine for ages 12 and over and R 21 for malaria prevention recommended for infants as young as five months of age.
我們的適用於 12 歲及以上兒童的 COVID 19 疫苗和用於預防瘧疾的 R 21 疫苗建議 5 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.
最後,我想提供有關我們新興的早期管道的最新資訊。
Our fourth value driver 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 Rex Sandra drag our strategy to drive value through innovation and R&D that leverages our validated technology platform is based on expansion beyond our existing core expertise in COVID 19 influenza and KIC vaccines, our R&D strategy will be executed within the framework and key guiding principles.
我們的第四個價值驅動因素約翰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一個主要關注點,我們很高興能夠在新任研發主管雷克斯·桑德拉博士的領導下繼續進行這項評估,推動我們的策略推動透過利用我們經過驗證的技術平台的創新和研發創造價值,其基礎是超越我們在COVID 19 流感和KIC 疫苗方面現有核心專業知識的擴展,我們的研發策略將在框架和關鍵指導原則內執行。
John noted earlier.
約翰早些時候指出。
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 I&D enabling activities.
兩者都基於我們的蛋白質奈米粒子和矩陣 M 技術平台,我們希望透過 I&D 支援活動來推進兩者。
In the near term, we will focus on exploring RSV containing combinations that would give this acting candidate the highest probability of success given the number of RSV standalone vaccines.
短期內,我們將重點探索含有 RSV 的組合,考慮到 RSV 獨立疫苗的數量,這將使該代理候選疫苗獲得最高的成功機率。
Now available characterization of our RSV candidate is ongoing in preparation for an I&D enabling toxicology study that is planned to start next year for the 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 outside of RSV combinations and pandemic influenza.
目前,我們正在對我們的RSV 候選藥物進行可用表徵,為I&D 毒理學研究做準備,該研究計劃於明年開始,針對大流行性流感候選藥物的毒理學研究目前正在進行中,我們正在與相關政府機構積極討論資助機會,以支持除 RSV 組合和大流行性流感之外,該有前途的候選藥物的早期和後期臨床開發和生產。
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 different differentiating attributes for potential advancement to I&D.
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不同的差異化屬性,以實現 I&D 的潛在進步。
We will prioritize areas where we believe we can make a meaningful impact while leveraging our existing expertise areas that are currently under consideration for more rigorous scientific and business case analysis range from reactivated infections that are known to be vaccine preventable, such as veracel exore, where our technology has produced a candidate VVV vaccine that we believe may be better tolerated and comparably effective to the currently approved vaccine.
我們將優先考慮我們認為可以產生有意義影響的領域,同時利用我們現有的專業知識領域,這些領域目前正在考慮進行更嚴格的科學和商業案例分析,範圍包括已知可透過疫苗預防的重新激活的感染,例如veracel exore,其中我們的技術已經生產出一種候選 VVV 疫苗,我們相信該疫苗可能比目前批准的疫苗具有更好的耐受性和相當的有效性。
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.
市場規模很大,需要很大的領域,例如艱難梭菌等抗生素相關感染,這些領域的科學挑戰是巨大的,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.
我們打算評估傳染病方面的這些機會和其他機會。
And we intend to prioritize our efforts over the next few months to make decisions on which preclinical programs we want to advance.
我們打算在接下來的幾個月中優先考慮我們要推進哪些臨床前項目的決定。
Finally, the third step in our portfolio development process, 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.
最後,我們的產品組合開發過程的第三步,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當前的方法。
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.
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。
And beyond 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.
除此之外,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產生概念驗證的數據。
Before establishing a formal development program, we plan to apply a low cost approach with rapid in vitro assessments and nonclinical models to identify a small number of specific diseases.
在建立正式的開發計劃之前,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。
For further focused assessment, key considerations include balancing available resources and necessary spend by leveraging existing screening technologies and collaborations.
為了進一步進行有針對性的評估,關鍵考慮因素包括透過利用現有的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。
Unidentified_6
Unidentified_6
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, please turn to side 20.
我們結果的詳細資訊可以在我們的新聞稿和 10-Q 文件中找到,請參閱第 20 面。
We remain focused on improving the financial strength and performance of NOVEX to drive shareholder value.
我們仍然專注於提高 NOVEX 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 for the third quarter of 2024 novax 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.
首先,我將介紹第三季的關鍵主題,並對2024 年剩餘時間及以後的情況進行展望。並反映了最初的庫存訂單,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 Novax into a more lean and agile organization, we reduced our Q3 2024 R&D and SG and A expenses by 26% compared to prior year for full year 2024.
隨著我們繼續將 Novax 轉型為更精簡和敏捷的組織,我們在 2024 年第三季的研發以及 SG 和 A 費用與前一年相比,2024 年全年減少了 26%。
We are reiterating the guidance range for R&D and SGNA expenses of between 707 150 million at midpoint.
我們重申研發和 SGNA 支出的指引範圍為 7,071.5 億美元的中位數。
This reflects a decrease of approximately 40% in 500 million as compared to full year 2023 NOVAX is prepared to initiate an additional cost reduction program to reduce combined R&D and SG expenses in 2025 and 2026 to better align our go forward cost structure with our value creation strategy.
這反映出與2023 年全年相比,減少了約40%(5 億美元)。地調整我們的未來成本結構與我們的價值創造策略。
We maintained a strong cash position and ended the third quarter of 2024 with over a 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 AP S to enable a smooth transition of commercial leadership to Sanofi.
最後,我們仍然專注於優先完成 AP S,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.
請參閱投影片 21,以了解我們第三季的更詳細資訊。
2024 financial results for the third quarter of 2024 we recorded total revenue of 85 million compared to 187 million for the same period in 2023 of note product sales for the third quarter of 2024 were 38 million compared to 2 million in the same period for 2023.
2024 年財務業績2024 年第三季我們的總營收為8,500 萬美元,而2023 年同期為1.87 億美元;2024 年第三季的票據產品銷售額為3,800 萬美元,而2023 年同期為200 萬美元。
As a result of higher us market sales in the current quarter, our cost of sales for the third quarter of 2024 were 61 million as compared to 99 million for the same period in 2023.
由於本季美國市場銷售額增加,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 Novax is combined R&D and SDNA expenses of 158 million reflects a 26% reduction from the same period.
2024 年第三季度,Novax 的研發和 SDNA 支出合計為 1.58 億美元,較同期減少 26%。
In 2023 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.
到 2023 年,本季金額中約有 3,000 萬人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 to advance that goal.
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,以推進這一目標。
We expect to reduce our R&D plus D&A to approximately 350 million in 2026 an approximately 1.4 billion, an 80% decrease when compared to full year 2022 for 2025 and net of expected reimbursement.
我們預計到 2026 年,我們的研發加上 D&A 費用將減少至約 3.5 億美元,約 14 億美元,與 2022 年全年相比,2025 年減少 80%(扣除預期報銷)。
We expect our non-GAAP combined R&D and DNA to be approximately 450 million to achieve this Novax is prepared to initiate an additional cost reduction program to better align our go forward cost structure with our value creation strategy as we transition lead commercial activities to Sanofi, this will enable the reduction of commercial and supply chain costs.
我們預計,為了實現這一目標,我們的非GAAP 研發和DNA 合計約為4.5 億美元,Novax 準備啟動一項額外的成本削減計劃,以便在我們將主導商業活動轉移給賽諾菲時,更好地調整我們的未來成本結構與我們的價值創造策略,這將有助於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 cost.
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 at midpoint of 675 million.
我們正在將總收入指引從先前的 7 億至 8 億(中間值 6.75 億)修改為 6.5 億至 7 億之間。
This is a 75 million decrease to our total revenue guidance based on a revised full year 2024 product sales guidance, we now expect product sales of between 175 million and 225 million at midpoint of 200 million.
根據修訂後的 2024 年全年產品銷售指導,這比我們的總收入指引減少了 7,500 萬份,我們現在預計產品銷售額在 1.75 億份至 2.25 億份之間,中間值為 2 億份。
This revised guidance includes 100 million from EP delivered in the first half of 2024 and 100 million commercial market.
此次修訂後的指導意見包括 2024 年上半年交付的 1 億個 EP 和 1 億個商業市場。
Product sales from the US market and ex US markets in the second half of 2024.
2024年下半年美國市場及美國以外市場的產品銷售情形。
The decrease of 125 million at midpoint compared to prior guidance is driven primarily by our COVID 19 trends in the US market.
與先前的指導相比,中位數減少了 1.25 億,這主要是由於我們美國市場的 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.
我們也正在修訂和提高 2024 年全年授權使用費和其他收入指導,目前預計達到 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,這是由賽諾菲協議下的預付款和成本報銷的收入確認共同推動的。
A few comments on our expectations for 2025 and beyond for the remaining AP a agreements.
關於我們對 2025 年及以後剩餘 AP a 協議的預期的一些評論。
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 to be conservative.
我們的目的是友好地談判或提供劑量,或在適當的時候達成退出協議,以使這些活動的目標是現金流中性或在未來保守的基礎上有利。
We have removed AP a sales from our forward-looking revenue expectations until further clarity is available for each.
我們已將 AP 銷售從我們的前瞻性收入預期中刪除,直到每一項都進一步明確。
Our current operating plan including the multi year expense targets.
我們目前的營運計劃包括多年費用目標。
Highlight a path to our goal of maintaining at least 1 to 2 years of cash on hand prior to receipt of cash flows from the Sanofi Agreement in the form of milestones and royalties.
強調實現我們目標的路徑,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 1 至 2 年的手頭現金。
Please turn to slide 24 as we enter 2025 the future cash flows to the company under the Sanofi Agreement become of greater importance.
請參閱投影片 24,隨著我們進入 2025 年,賽諾菲協議下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 for the 350 million and to vaccinate COVID 19 milestones.
我們預計,根據該協議,近期將有多達 7 億人接種新冠肺炎 (COVID-19) 和流感新冠肺炎聯合疫苗里程碑事件,並為 3.5 億人接種新冠肺炎 (COVID-19) 里程碑疫苗。
We expect to complete database lock of a related pediatric clinical trial in the fourth quarter of 2024 which would enable earning the 1st 50 million milestone revenue recognition for this milestone will be allocated over the transition services period through 2026.
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,這將使該里程碑獲得第一個 5000 萬美元的里程碑收入確認,該收入將在截至 2026 年的過渡服務期間分配。
All other milestones under the agreement will be recognized in full in the period when earned the 175 million B milestone is anticipated to align with our B Padua action date and approval which is presently targeted for April 2025.
該協議項下的所有其他里程碑將在獲得 1.75 億 B 里程碑的期間獲得全額認可,預計與我們的 B 帕多瓦行動日期和批准一致,目前目標是 2025 年 4 月。
The 2 25 million authorization transfer milestones are expected to follow as we enable Sanofi to commercialize Nox in the US and Europe for the 2025 26 vaccination season.
隨著我們幫助賽諾菲在 2025 年 26 疫苗接種季節在美國和歐洲將 Nox 商業化,預計將實現 2.25 億次授權轉讓里程碑。
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 for the Sanofi flu COVID 19 program.
預計在我們完成賽諾菲流感 COVID 19 計畫的過渡服務義務後,實現 7,500 萬項技術轉移的里程碑,目前我們預計該義務將在 2026 年底實現。
There are two milestones totaling 350 million related to the development and first commercial US commercial sale.
與開發和首次在美國商業銷售相關的兩個里程碑總計 3.5 億美元。
Sanofi recently noted on their Q3 earnings call that they expect to start their phase 12 study this year and if that data are positive, they would move towards phase three in 2025.
賽諾菲最近在第三季財報電話會議上指出,他們預計今年將開始第 12 階段研究,如果數據積極,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, standalone 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 Novax.
這使得 Novax 成為可能。
Novavax's meaningful participation in future economics from the current and future products.
Novavax 從目前和未來的產品中有意義地參與未來經濟。
Under this agreement, Novax will support SINOS prepares to advance all programs associated with this agreement and Novax will be eligible for cost reimbursement across a host of spend categories.
根據該協議,Novax 將支援 SINOS 準備好推進與該協議相關的所有計劃,並且 Novax 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.
我們預計這筆補償將在 2025 年和 2026 年期間進行。
As we supply product conduct R&D and technical transfer activities for products supplied to Sanofi, we will book both cost of goods sold and reimbursement revenue.
當我們為賽諾菲供應的產品進行產品研發和技術轉移活動時,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.
就這樣。
I'd like to turn the call back over to John for some closing remarks.
我想將電話轉回給約翰,讓他做一些結束語。
Unidentified_3
Unidentified_3
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。
Unidentified_1
Unidentified_1
We will now begin the question and answer session to ask a question.
我們現在開始問答環節來提問。
You may press star then one on your touchtone phone.
您可以按按鍵式電話上的星號,然後按一個。
If you are using a speakerphone, please pick up your handset before pressing the keys to withdraw your question.
如果您使用免持電話,請在按按鍵撤回問題之前拿起聽筒。
Please press star.
請按星號。
Then two at this time, we will pause momentarily to assemble the roster.
那麼此時兩點,我們將暫停一下以集合名單。
The first question comes from Roger Song with Jefferies LLC.
第一個問題來自 Jefferies LLC 的 Roger Song。
Please go ahead.
請繼續。
Unidentified_7
Unidentified_7
Thank you.
謝謝。
Thanks for the update and then congrats on the speedy removal of the clinical hold on your kick and the flu program.
感謝您的更新,然後祝賀您迅速取消了對您的踢球和流感計劃的臨床限制。
So a couple of questions from us maybe first on the clinical hold removal.
因此,我們首先可能會問一些關於臨床保留解除的問題。
Understanding you want to start a phase three 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 star?
您能給我們一些關於恆星出現時間的澄清嗎?
You know what will be the gating factor for you to start the phase three?
您知道開始第三階段的限制因素是什麼嗎?
And then given this severe sae occurrence, how much additional safety requirement now is in place or required by the FDA?
那麼考慮到這種嚴重的 SAE 事件,FDA 現在製定或要求了多少額外的安全要求?
Any potential post marketing requirement suggested or recommended by the FDA?
FDA 建議或推薦的任何潛在的上市後要求?
I have a couple follow up.
我有幾個跟進。
Thank you.
謝謝。
Unidentified_3
Unidentified_3
Thank you, Roger.
謝謝你,羅傑。
We'll let Bob Walker address your questions starting with timing, Bob.
鮑勃,我們將讓鮑勃沃克從時間開始解決您的問題。
Unidentified_5
Unidentified_5
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, you know, the weekend and yesterday to assess and I would say that we're working on study logistics right now.
所以我們週末和昨天都進行了評估,我想說我們現在正在研究後勤工作。
Our intent, of course, as you've heard 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 expected in the coming weeks, we will be able to provide more clarity on the specifically when we plan to start the trial, the 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.
我們目前不准備向您提供具體的開始日期,但預計在未來幾週內,我們將能夠更清楚地說明我們計劃開始試驗的具體時間,讓我提醒您,安全性我們確定向FDA 報告的導致臨床暫停的事件與研究疫苗無關。
And based on the FDA'S reaction, it appears that they concur with our assessment, it certainly substantiates our assessment.
根據 FDA 的反應,他們似乎同意我們的評估,這當然證實了我們的評估。
So in terms of additional safety precautions that need to be introduced, they're, they're really the standard safety oversight and monitoring that essentially was already in the trial or with 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點時根據來回的情況進行了輕微的調整事件。
So what I'm trying to say is we don't expect an impact from any of those kind of operational changes to the protocol other than the standard types of impacts that are, you know, that everyone encounters when they make administrative changes to a protocol.
So what I'm trying to say is we don't expect an impact from any of those kind of operational changes to the protocol other than the standard types of impacts that are, you know, that everyone encounters when they make administrative changes to a協定.
Unidentified_3
Unidentified_3
And Roger, this is John.
羅傑,這是約翰。
Thank you for your congratulations on that hold being lifted.
感謝您對解除保留表示祝賀。
We're very excited about them and we were to just build upon Bob's answer.
我們對他們感到非常興奮,我們只是以鮑伯的答案為基礎。
We were ready to go on track to go Bob right in Q4 with our study.
我們已準備好在第四季度透過我們的研究步入正軌,追隨鮑伯的腳步。
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,這是明確和預期的,我們只需要重新設定並繼續。
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。
Unidentified_7
Unidentified_7
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.
所以也許吧。
Unidentified_3
Unidentified_3
Shift to Roger.
轉移到羅傑。
Let me just clarify.
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.
但在完成計劃之前,我們不想給出具體日期。
That's what we were saying.
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.
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。
Unidentified_7
Unidentified_7
Got it.
知道了。
Okay.
好的。
Your turn.
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 QA data since you got, you know, at least from the for a third party, the script capturing you have one around 1 60,000 scripts in the retail channel.
因此,我們都追蹤 QA 數據,因為您知道,至少從第三方獲得的腳本捕獲了零售通路中約 1 60,000 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。
Unidentified_3
Unidentified_3
Go ahead John, you want to take that one?
來吧,約翰,你想拿那個嗎?
Unidentified_4
Unidentified_4
Yeah, so just a little bit of clarification on 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 IQV 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 IQV 數據是一個比去年早一點開始的季節。
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 we're seeing a AAA leveling off of shots in arms into the marketplace through retail pharmacies.
我們看到 AAA 級藥物透過零售藥局進入市場。
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。
You know, 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 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 2,425 season just to be clear about how some other numbers have been reported by other other companies.
你知道,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,以確定是否這對於整個賽季的剩餘時間、整個2,425 賽季來說都是如此,只是為了清楚其他公司如何報告其他一些數字。
This would take us through through the first quarter.
這將帶領我們度過第一季。
So far, you know, we're holding at about approximately 3% market share.
到目前為止,我們佔有約 3% 的市場份額。
We're significantly greater even season to date than we did in all of last season, some 3 to 4 times, the total number of what we did already in in market expect that to continue.
到目前為止,我們本賽季的表現比上賽季整個賽季的表現都要好得多,大約是我們在市場上已經做的事情的 3 到 4 倍,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 you know where we, you know, the ACU data is hovering somewhere around total 800,000 doses or so shots in arms at this point.
但你知道,我們,你知道,ACU 數據目前徘徊在大約 80 萬劑左右的位置。
And I think that that's, that's significant.
我認為這很重要。
Unidentified_1
Unidentified_1
Got it.
知道了。
Unidentified_4
Unidentified_4
Thank you.
謝謝。
Unidentified_1
Unidentified_1
And the next question comes from Mayank Montani from B Riley Securities.
下一個問題來自 B Riley 證券公司的 Mayank Montani。
Please go ahead.
請繼續。
Unidentified_8
Unidentified_8
Good morning team.
早上好,團隊。
Thanks for taking our questions and, and, and welcome aboard Roana.
感謝您提出我們的問題,歡迎登上 Roana。
So may maybe just some following up on the prior question.
所以也許只是對之前的問題進行一些跟進。
You know, just thinking forward-looking in terms of having the vaccine now as part of Sanofis product portfolio and, and distribution channel next year, are you able to comment on, you know what you know, trends around net price.
您知道,只要前瞻性地考慮將疫苗現在作為賽諾菲斯產品組合的一部分以及明年的分銷管道,您是否能夠評論圍繞淨價的趨勢,您知道您所知道的。
I know market share might be too early to comment on, but just split by channel and, and some of the pricing dynamic 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,並且一些定價動態可能看起來像。
And then I.
然後我。
Unidentified_3
Unidentified_3
Have a follow up, go ahead John T.
繼續跟進,John T.
Unidentified_4
Unidentified_4
This is really important so far about what is happening this year versus what is happening, you know, next year with Santa, right?
到目前為止,這一點對於今年發生的事情和明年聖誕老人發生的事情非常重要,對吧?
Of course, this partnership is, 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, there's a high level of cooperation and collaboration across all markets and and, and so therefore, what we expect to see happening as they fully embrace the relationship.
我們還沒有看到這種關係的好處,我們正在開始所有的過渡活動,所有市場之間都有高水準的合作與協作,因此,當他們完全接受時,我們期望看到發生的事情的關係。
You know, next year is the depth and strength of their marketing capabilities.
要知道,明年是他們行銷能力的深度和強度的一年。
Globally us Europe across, across the globe.
全球範圍內,我們歐洲各地,全球各地。
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 2,526 season.
因此,當我們進入 2,526 賽季時,我們看到了重大進展。
Unidentified_8
Unidentified_8
I understood and then on the structure quickly, how how are you thinking steady state in this 2026 27 time frame?
我很快就理解了結構,您如何看待 2026 年 27 日這個時間框架內的穩定狀態?
Knowing, you know, you may not have a commercial infrastructure there and then may not look to perhaps even do a large scale phase three program beyond obviously, the phase three K program you're executing.
你知道,你可能在那裡沒有商業基礎設施,然後可能不會考慮除了你正在執行的第三階段 K 計劃之外進行大規模的第三階段計劃。
Unidentified_4
Unidentified_4
So I think to make sure I understand your question correctly as a commercial infrastructure to support any other future development activities.
所以我想確保我正確理解你的問題作為商業基礎設施來支援任何其他未來的開發活動。
If that's, if that's the question, I think what we're primarily looking at is partnering some of these latest stage assets, right?
如果是這樣,如果這是問題,我認為我們主要考慮的是與一些最新的階段資產合作,對嗎?
And, and not having the significant cost infrastructure to support a commercial organization, you know, going forward and we would see the benefit of partnering out these assets, you know, going forward, which is exactly what we did with Sanofi and what we potentially do with our own, you know, KIC program going forward.
而且,由於沒有大量的成本基礎設施來支持商業組織,你知道,未來我們會看到與這些資產合作的好處,你知道,未來,這正是我們與賽諾菲所做的以及我們潛在的繼續我們自己的KIC 計劃。
Unidentified_6
Unidentified_6
In my view, if you kind of look back at the some of the prepared remarks I provided earlier.
在我看來,如果你回顧我之前提供的一些準備好的評論。
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 called it field based medical affairs activities.
我指出的你將會看到的一件事是,本季度我們有大約 3000 萬美元與商業相關的支出,並將其稱為基於現場的醫療事務活動。
So at annual rise to about 120 million that we don't expect and anticipate spending in future years.
因此,如果每年增加到約 1.2 億,我們預計並預計未來幾年的支出不會增加。
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 SDNA in line with the guidance, we've been providing.
這就是為什麼我們對我們能夠按照我們一直提供的指導繼續降低研發和 SDNA 運行率的能力充滿信心的部分原因。
Unidentified_8
Unidentified_8
Understood and and lastly on your next IND filing coming from Bob and Roxana, I, I know you talked about a number of pipeline initiatives, just maybe if you narrow down on what could be the next IND filing for, you know, one of your prioritized programs and, and in the same context, if you are able to talk to also sign of prioritization of any next candidate beyond the the accident would also be helpful.
理解,最後關於 Bob 和 Roxana 提交的下一個 IND 申請,我知道您談到了一些管道計劃,也許如果您縮小下一個 IND 申請的範圍,您知道,您的一個優先計劃,並且在相同的情況下,如果您能夠與事故之外的任何下一個候選人的優先順序進行交談,也會有所幫助。
Thanks again for taking my question.
再次感謝您提出我的問題。
Unidentified_3
Unidentified_3
Bob.
鮑伯.
Do you want to take the question on thoughts around our next in and how we're approaching that process?
您想回答有關我們下一步的想法以及我們如何處理流程的問題嗎?
Unidentified_5
Unidentified_5
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 I&D and in or soon to begin I&D enabling activities.
正如我在未來的研發策略中提到的,我們現在確實有兩位候選人正在轉向 I&D 並正在或即將開始 I&D 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, but those are the two that I think I would regard as being next in line.
因此,我認為在時間方面給你們更具體的資訊還為時過早,但我認為我認為下一個是這兩個。
And then, you know, the other, the other areas that we talked about will be able to, you know, give you more clarity in the months ahead.
然後,你知道,我們討論的其他領域將能夠在未來幾個月讓你更加清晰。
But yeah.
但是是的。
Okay.
好的。
I think, I think that answers your question.
我想,我想這回答了你的問題。
Let me know.
讓我知道。
Unidentified_3
Unidentified_3
Thank you, Bob and Mike, you asked a second question about Sanofi, obviously in their most recent earnings call, they noted they're preparing to initiate a phase 12 KIC study this year.
謝謝鮑伯和麥克,你們問了關於賽諾菲的第二個問題,顯然是在他們最近的財報電話會議上,他們指出他們準備今年啟動第 12 階段 KIC 研究。
And with a positive readout, if they get that positive readout, they would move towards a phase three.
有了積極的讀數,如果他們得到積極的讀數,他們將進入第三階段。
Sometime in 2025 you can go check their commentary to clarify that for your notes and then we can't comment on any other things that Sanofi may be working on right now.
2025 年的某個時候,您可以去查看他們的評論,以澄清您的筆記,然後我們無法對賽諾菲目前可能正在研究的任何其他事情發表評論。
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.
但我認為,請大家回顧我們簽訂的合約和協議,其中有多種機會與賽諾菲就我們的 Matrix M 佐劑進行合作。
And they can also make that they're choosing multiple combinations with COVID vaccine.
他們還可以選擇多種新冠疫苗組合。
Should they choose to do so?
他們應該選擇這樣做嗎?
Each new asset they would, they would develop with matrix M has towards 200 million in potential onetime milestone payments and ongoing royalties for years to come.
他們使用矩陣 M 開發的每項新資產都可能有 2 億美元的潛在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.
因此,隨著時間的推移,該合約肯定有很多開發多種資產的機會。
Should they choose to take that pathway?
他們應該選擇走這條路嗎?
You'll have to look to them for further commentary on the plans.
您必須向他們尋求有關該計劃的進一步評論。
Unidentified_8
Unidentified_8
Noted.
著名的。
Thank thanks for that.
謝謝你。
Helpful color and congrats on the.
有用的顏色,恭喜。
Unidentified_3
Unidentified_3
Progress.
進步。
Thank you, Mike.
謝謝你,麥克。
Unidentified_1
Unidentified_1
And the next question comes from Alex Stranahan with Bank of America.
下一個問題來自美國銀行的 Alex Stranahan。
Go ahead.
前進。
Unidentified_9
Unidentified_9
Hi guys, Matthew.
大家好,馬修。
I'm for Alec here.
我是為了亞歷克。
Thanks for taking our questions and congrats on the choir.
感謝您提出我們的問題,並對合唱團表示祝賀。
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 new activ 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?
好奇您是否可以提供一些有關今年新活動的淨價的信息,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會出現類似情況?
Unidentified_4
Unidentified_4
Sorry, if you could just restate the question real quick.
抱歉,如果您能快速重述問題的話。
Sorry.
對不起。
Unidentified_9
Unidentified_9
Yeah, just looking for some color on the net price for new back this year.
是的,只是在今年新背部的淨價上尋找一些顏色。
And how much of that was outside of retail and whether you expect those dynamics to continue in the upcoming years?
其中有多少是在零售業之外的?
Unidentified_6
Unidentified_6
Yeah, go ahead.
是的,繼續吧。
Excellent.
出色的。
Hey, I'm happy to address the net price question while we have not given a specific net price.
嘿,我很高興回答淨價問題,但我們沒有給出具體的淨價。
Some of the feedback that I've shared more generally about this marketplace has been the following.
我更廣泛地分享的有關該市場的一些反饋如下。
You know, all three COVID vaccines on a on a gross basis are approximately the same around 140 per dose.
您知道,所有三種新冠疫苗的總量大致相同,每劑約 140 粒。
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.
可以合理地假設扣除後的淨價將佔總價的 50% 至 75%,這將使您的價格達到 70 至 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 and then with respect to the retail versus nonretail, let John comment on market dynamics last year and what we're seeing this year as well.
但我認為這確實會給您帶來一種普遍的看法,然後關於零售與非零售,讓約翰評論一下去年的市場動態以及我們今年所看到的情況。
Unidentified_4
Unidentified_4
Yeah, and let me just follow up just a point of clarification on a previous question, right?
是的,讓我對先前的問題進行澄清,對吧?
So while we're we're looking at I QIA data and there are multiple sources of shots and arms data and also there's the what's revenue generating out to the distributor versus what actual shots and arms are?
因此,當我們查看 I QIA 數據時,鏡頭和武器數據有多個來源,而且分銷商所產生的收入與實際鏡頭和武器是什麼?
The clarification?
澄清?
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.
我說的是 800,000 劑,實際數字接近 500,000 劑,僅從 IQVIA 數據中得出一周的滯後。
So a lot of data points here, 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.
這裡有很多數據點,我認為更新後的指導考慮了所有趨勢,以及我們迄今為止在市場上看到的情況,但只是為了清楚和具體地說明 Iqvia 數據迄今為止報告的內容。
Operator.
操作員。
Next.
下一個。
Unidentified_1
Unidentified_1
Question, the next question comes from Eric Joseph from JP Morgan.
問題,下一個問題來自摩根大通的埃里克約瑟夫。
Please go ahead.
請繼續。
Unidentified_10
Unidentified_10
You on the phase three kick trial.
您正在進行第三階段的踢球試驗。
Your prior guidance was for an expected re in the mid 25 time frame.
您之前的指導是預計在 25 小時內進行重新調整。
Is that still your expectation or should we be carrying more conservative, you know, timeline assumption perhaps in the second half.
這仍然是您的期望嗎?
And just kind of having gone through this clinical hold experience.
就好像經歷過這種臨床保留經驗。
I I wonder to what extent your phase three IND might be exposed to any additional longer term follow up from the phase two trial.
我想知道您的第三階段 IND 在多大程度上可能會受到第二階段試驗的任何額外長期追蹤。
Have you sort of reviewed any, you know, potential at risk patients to sort of, you know, rule out the potential for similar, you know SAE type of events.
您是否對任何潛在風險患者進行了審查,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 standalone flu portion of the phase three study, I just want to confirm whether that would be intended for and the design is intended to support registration of this blue standalone.
最後,當它涉及第三階段研究的獨立流感部分時,我只想確認這是否是為了支持這個藍色獨立的註冊,並且設計是否旨在支持註冊。
And if so, whether you have superior immunity in mind there via the within the trial design or if it's more around a noninferior signal.
如果是這樣,您是否透過試驗設計考慮到了優越的免疫力,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。
Unidentified_3
Unidentified_3
Thank you for your questions, Eric, I think you had three questions into the question there.
謝謝你的提問,艾瑞克,我認為你在這個問題中提出了三個問題。
So let's but very good points.
所以讓我們來談談非常好的觀點。
So number one on timing, we did address that a little earlier.
因此,關於時間的第一點,我們確實早些時候解決了這個問題。
Let me just reframe that.
讓我重新定義一下。
So everyone's clear that we were on track in Q4 as we stated before to initiate our trial and then the clinical hold occurred.
因此,每個人都清楚,正如我們之前所說,我們在第四季度步入正軌,啟動了試驗,然後發生了臨床擱置。
We're happy that that was lifted in a short order and now we're gearing up to reinitiate that trial.
我們很高興這一問題在短時間內得到了解除,現在我們正準備重新啟動該試驗。
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,我們剛剛在周五收盤時收到 FDA 的回饋,所以週末和昨天就進行了處理。
So we're not going to commit to a precise timing to restart that trial or to start that trial.
因此,我們不會承諾重新啟動該試驗或開始該試驗的精確時間。
Now, I should say, 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, but we don't see a significant delay.
現在,我應該說,但在短期內,再過幾週左右,我們將能夠更清楚地說明試驗開始時間,但我們沒有看到明顯的延遲。
We think we can get it started relatively in the near term.
我們認為我們可以在短期內啟動它。
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, Bob.
謝謝你提出這個問題,鮑伯。
Did you want to take the other two questions that Eric had?
你想回答艾瑞克提出的另外兩個問題嗎?
Thank you.
謝謝。
Unidentified_5
Unidentified_5
Sure.
當然。
So the follow up on the trial is the standard length of safety monitoring for adjuvanted vaccines.
所以試驗的後續是佐劑疫苗安全性監測的標準時長。
And I think I'll just leave it there.
我想我會把它留在那裡。
And in terms of the design for the phase three and the flu standalone product similar to KIC, the, the intent of the study is to demonstrate noninferior immunogenicity.
就第三階段的設計和類似 KIC 的流感獨立產品而言,研究的目的是證明非劣效的免疫原性。
So that's true for the KIC product and that's equally true for our flu standalone.
對於 KIC 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更多的非劣效性數據。
So, you know, the statistical analysis has the ability to demonstrate superiority, but the study is designed and powered for noninferiority.
所以,你知道,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。
Unidentified_3
Unidentified_3
And I think Eric was also asking Eric if we heard your question correctly.
我認為埃里克也在問埃里克我們是否正確地聽到了你的問題。
Is that designed for registration that trial, Bob?
鮑勃,這個試驗是為了註冊而設計的嗎?
Could it provide a registrational opportunity?
它可以提供註冊機會嗎?
Unidentified_5
Unidentified_5
Yeah.
是的。
Yeah, absolutely.
是的,絕對是。
This study is designed as a phase three, a immunogenicity trial to support licensure of the products with the understanding that a follow on clinical efficacy trial would need to be demonstrated postapproval.
這項研究被設計為第三階段,一項免疫原性試驗,以支持產品的許可,但需要在批准後證明後續的臨床療效試驗。
Unidentified_3
Unidentified_3
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.
再次強調,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,鮑伯。
Correct.
正確的。
That's.
就是這樣。
Unidentified_5
Unidentified_5
Right.
正確的。
Excellent.
出色的。
Well, thank you very.
嗯,非常感謝。
Unidentified_10
Unidentified_10
Much for taking the questions.
非常適合回答問題。
Unidentified_1
Unidentified_1
The next question comes from Brendan Smith from TD Cowan.
下一個問題來自 TD Cowan 的 Brendan Smith。
Please go ahead.
請繼續。
Unidentified_11
Unidentified_11
Hi, this is Jack for Brandon.
嗨,我是布蘭登的傑克。
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?
Unidentified_3
Unidentified_3
Jim Kelly, you want to take the analyst.
吉姆凱利,你想帶分析師。
Unidentified_6
Unidentified_6
Day?
天?
Yes, certainly.
是的,當然。
And thanks for the question.
謝謝你的提問。
And you know, 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.
你知道,隨著我們進入 novavax 的後商業版本,我們真的很期待公佈越來越多的想法,不僅僅是研發,還有所有四個支柱。
You know, 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 at the end of February.
你知道,我們對這將如何展開的預期是,從現在到我們第四季的收益(將於二月底),你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 at some point in 2025.
然後我們認為,我們最有能力在 2025 年的某個時間點之後做一些類似投資者的事情。
So that's our, that's our thinking, you know, expect to hear more of our thinking unfold as the coming months go by.
這就是我們的想法,你知道,希望在接下來的幾個月裡聽到我們更多的想法。
We're really excited to have Roxana here and everything she's going to bring to our very thoughtful and disciplined approach.
我們非常高興 Roxana 來到這裡,以及她將為我們深思熟慮和紀律嚴明的方法帶來的一切。
To advancing our investments in our technology.
推進我們對科技的投資。
Unidentified_1
Unidentified_1
Great.
偉大的。
Thank you.
謝謝。
Once again, if you have a question, press star followed by the one and the next question comes from Vernon Bernardino from HC Wainwright.
再一次,如果您有問題,請按星號,然後是一個問題,下一個問題來自 HC Wainwright 的 Vernon Bernardino。
Go ahead.
前進。
Unidentified_12
Unidentified_12
Hi, thanks for taking my question.
您好,感謝您提出我的問題。
I actually have two questions.
我其實有兩個問題。
Excuse me.
打擾一下。
The first question I had is there's some evidence that the flu vaccine this year was not as good as in prior years.
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 cake vaccine formulation for the flu vaccine component is handling that.
只是想知道流感疫苗成分的蛋糕疫苗配方是如何處理這個問題的。
And then 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。
Unidentified_3
Unidentified_3
Bob.
鮑伯.
You want to take Vernon's first question.
你想回答佛農的第一個問題。
Unidentified_5
Unidentified_5
So the strains that we're using in the, that we are planning to use in the phase three trial are the US or northern hemisphere strains for the last season for the season that we're currently in.
因此,我們計劃在第三階段試驗中使用的菌株是我們當前所處季節的最後一個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,該試驗並非設計為臨床療效試驗,而是比較免疫原性研究,對嗎?
So the readout is going to be whether or not the immune responses induced by the flu component in their vaccine are not inferior to the imagic of the comparator flu vaccine and in good efficacy years or less good efficacy years of the image EIC is, is a kind of a standalone readout that's that's going to be driving the analysis of this study.
因此,讀數將是其疫苗中流感成分誘導的免疫反應是否不遜色於對照流感疫苗的效果,並且在圖像的良好療效年份或較差療效年份中,EIC 是,是一種獨立的讀數將推動這項研究的分析。
So I don't, it's very helpful.
所以我不這樣做,這非常有幫助。
Unidentified_6
Unidentified_6
Thank you.
謝謝。
Unidentified_5
Unidentified_5
Yeah.
是的。
Okay.
好的。
Unidentified_6
Unidentified_6
Ben and happy to answer the question about gross margins in 2025 and forward.
Ben 很高興回答有關 2025 年及以後毛利率的問題。
You know, this year is our last commercial year.
要知道,今年是我們最後一個商業年。
Certainly in us markets Europe.
當然是在美國市場和歐洲。
We had noted that while there's some trailing A PS, we're excluding them from our future guidance at this time.
我們注意到,雖然有一些尾隨的 A PS,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, you know, what will be our cost of goods sold for 2,526 and beyond, it is going to reflect providing supply to Sanofi for 2025 and 2026.
因此,我的評論重點是,您知道,我們以 2,526 美元及以上的價格銷售的商品成本是多少,它將反映 2025 年和 2026 年向賽諾菲提供的供應。
That's on a cost plus basis.
這是在成本加成的基礎上。
And so you can see that, you know, the traditional commercial company relevance of gross margin is not going to be the same from 25 for that's going to be a more cost.
所以你可以看到,傳統商業公司的毛利率相關性與 25 相比將有所不同,因為這將帶來更多成本。
Plus.
加。
Unidentified_1
Unidentified_1
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。
One moment please while we reconnect.
請稍等一下,我們重新連接。
Ladies and gentlemen, the conference will resume momentarily.
女士們、先生們,會議馬上恢復。
Please hold on.
請稍等。
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。
Unidentified_3
Unidentified_3
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.
看起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。
Unidentified_1
Unidentified_1
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。