Novavax 召開電話會議,討論 2023 年的財務表現和營運亮點,包括實現 10 億美元的收入。他們概述了流感-新冠聯合疫苗計劃和 2024 年的優先事項,例如提供更新的產品和啟動第三階段試驗。該公司對未來的成長潛力持樂觀態度,目標是成為全球領先的疫苗創新者。
他們討論了減少開支、提高市場份額以及尋求監管機構批准其疫苗。 Novavax 專注於創建精乾而敏捷的組織、改善財務狀況並推進其組合疫苗專案。他們有信心加快第三階段研究的批准,並正在努力爭取其產品獲得監管部門的批准。
使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning, and welcome to Novavax Fourth Quarter 2023 financial results and operational highlights conference call.
早安,歡迎參加 Novavax 2023 年第四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,正在記錄此事件。
I would now like to turn the conference over to Erica Schultz, Director, Investor Relations.
我現在想將會議交給投資者關係總監 Erica Schultz。
Please go ahead.
請繼續。
Erika Schultz - IR
Erika Schultz - IR
Good morning, and thank you all for joining us today to discuss our fourth quarter and full year 2023 operational highlights and financial results.
早安,感謝大家今天加入我們討論我們第四季度和 2023 年全年的營運亮點和財務業績。
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, I need to remind you that this presentation includes forward-looking statements, including information relating to the future of Novavax, its key strategic priorities, operating plans, objectives and prospects.
在我們開始準備好的發言之前,我需要提醒您,本簡報包含前瞻性陳述,包括與 Novavax 的未來、其關鍵策略重點、營運計劃、目標和前景相關的資訊。
Full year 2024 financial guidance the amount and impact of Novavax's cost reduction plans, its future financial or business performance conditions or strategies, its partnerships, anticipated timing and outcome of future regulatory filings and actions and the ongoing development, marketing opportunities, manufacturing capacity and future availability of our vaccine candidates and key upcoming milestones.
2024 年全年財務指導Novavax 成本削減計劃的金額和影響、其未來的財務或業務績效狀況或戰略、其合作夥伴關係、未來監管備案和行動的預期時間和結果以及正在進行的開發、營銷機會、製造能力和未來我們的候選疫苗的可用性以及即將到來的關鍵里程碑。
Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.
本簡報中包含的每項前瞻性陳述均面臨風險和不確定性,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 slide deck 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 www.SEC.gov and on our website, www.novavax.com. 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.
有關這些因素的更多信息,請參見我們今天上午發布的幻燈片中的“有關前瞻性陳述的注意事項”標題下以及我們向美國證券交易委員會提交的最新10 K 表格和隨後的10 Q 表格中的「風險因素」標題下的資訊。請造訪 www.SEC.gov 和我們的網站 www.novavax.com。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。
Joining me today is John Jacobs, our President and CEO, who will provide a review of our progress this past year, focusing on our three key priorities looking towards the future.
今天加入我的是我們的總裁兼執行長約翰·雅各布斯 (John Jacobs),他將回顧我們過去一年的進展,並專注於我們展望未來的三個關鍵優先事項。
Additionally, John Trizzino, our President and Chief Operating Officer, will provide an update on our commercial activities, and Dr. Filip Dubovsky, President of Research and Development, will discuss our clinical development and pipeline.
此外,我們的總裁兼營運長 John Trizzino 將提供我們商業活動的最新訊息,研發總裁 Filip Dubovsky 博士將討論我們的臨床開發和管道。
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。
Please turn to slide 4.
請翻到幻燈片 4。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, Erica, and thank you, everyone, for joining us.
謝謝你,艾麗卡,也謝謝大家加入我們。
I'm pleased to be with you today, along with the members of our executive team to reflect on our fourth quarter and full year 2023 financial results and operating highlights and to discuss our priorities for 2024 and 2023, we made significant progress in our priorities, strengthening our foundation and helping to position us for success in 24 and beyond throughout the year, we kept you updated on the progress we were making against our three priorities, which were number one, deliver an updated product for the fall vaccination season.
我很高興今天與大家一起,與我們的執行團隊成員一起回顧我們第四季度和2023 年全年的財務業績和經營亮點,並討論我們2024 年和2023 年的優先事項,我們在優先事項方面取得了重大進展,鞏固我們的基礎並幫助我們在24 小時及以後的一年中取得成功,我們隨時向您通報我們在三個優先事項方面取得的進展,這三個優先事項是第一,為秋季疫苗接種季節提供更新的產品。
Number two reduce our rate of spend, manage our cash flow and evolve our scale and structure.
第二,降低我們的支出率,管理我們的現金流並發展我們的規模和結構。
And finally, number three, leverage our technology platform, our capabilities and our assets to drive additional value beyond NeuVax alone.
最後,第三點,利用我們的技術平台、我們的能力和我們的資產來推動 NeuVax 以外的額外價值。
So let's take a look back at 2023 and what we were able to accomplish in these three key areas of focus for Novavax under priority one deliver our updated vaccine for the fall season.
因此,讓我們回顧一下 2023 年,以及我們在 Novavax 的這三個關鍵重點領域所取得的成就,第一要務是為秋季提供更新的疫苗。
All of us at Novavax are very proud that this fall we delivered on this priority.
Novavax 的所有人都為今年秋天實現了這一優先事項感到非常自豪。
And in the face of the COVID market that was smaller than we and many others had projected.
面對新冠疫情帶來的市場,這個市場比我們和許多其他人預期的要小。
We were able to achieve $1 billion of revenue for the full year 23, including fourth quarter total revenue of $291 million.
我們 23 年全年實現了 10 億美元的收入,其中第四季總收入為 2.91 億美元。
Despite this success, we also had some misses and we're disappointed in our US market performance last season.
儘管取得瞭如此成功,但我們也有一些失誤,我們對上賽季美國市場的表現感到失望。
Last season was a transitional season and the first fully commercial one for us in the US market, and we intend to make improvements in key areas for 2024.
上個賽季是一個過渡賽季,也是我們在美國市場的第一個完全商業化的賽季,我們打算在 2024 年在關鍵領域進行改進。
Later on in our presentation, John Trizzino will discuss this topic in more detail, priority number two, reduce our rate of spend, manage our cash flow and evolve our scale and structure. 2023 was a pivotal year for the COVID market and for Novavax, as it was the 1st year post pandemic and represented the first chapter in our new journey as a company post pandemic, a key priority for Novavax in 2023 was to scale the organization appropriately and reduce our spend to better align with the evolving market opportunity.
稍後在我們的演講中,約翰·特里齊諾 (John Trizzino) 將更詳細地討論這個主題,第二要務是降低我們的支出率,管理我們的現金流並發展我們的規模和結構。 2023 年對新冠病毒市場和Novavax 來說是關鍵的一年,因為這是大流行後的第一年,代表了我們作為一家公司在大流行後的新旅程的第一章,Novavax 2023 年的首要任務是適當擴大組織規模,減少我們的支出,以更好地適應不斷變化的市場機會。
To that end, we took decisive action to reduce our expenses and our scale, we entered 2023 with approximately $2.5 billion in current liabilities and over the course of the year, reduce that figure by over $800 million.
為此,我們採取果斷行動來減少開支和規模,進入 2023 年時,我們的流動負債約為 25 億美元,並在這一年中將該數字減少了 8 億多美元。
And with the resolution of the Dhabi arbitration, this number should be reduced further by another $500 million.
隨著札比仲裁案的解決,這個數字應該會再減少5億美元。
In addition, we reduced our total operating expenses by over $1.1 billion in 2023, almost $150 million ahead of our stated targets.
此外,到 2023 年,我們的總營運支出減少了超過 11 億美元,比我們既定目標提前了近 1.5 億美元。
And finally, under priority three, leveraging our technology platform, our capabilities and our assets to drive additional value beyond NeuVax that alone, during 2023, we were able to outline a faster path forward for our flu COVID combination vaccine program with a potential launch as soon as 2026.
最後,在優先事項三下,利用我們的技術平台、我們的能力和資產來推動NeuVax 以外的額外價值,在2023 年期間,我們能夠為我們的流感新冠聯合疫苗計劃勾勒出更快的前進道路,並有可能推出最快到 2026 年。
We are still on track to initiate a Phase three study this fall.
我們仍有望在今年秋天啟動第三階段研究。
And last week, the FDA confirmed the data requirements to achieve accelerated approval Dr. Filip, do Matthew will provide details later on the call on this matter.
上週,FDA 確認了實現加速批准的數據要求。Filip 博士、Matthew 博士將在稍後的電話會議上就此事提供詳細資訊。
So looking ahead to 2024 and beyond, I'd like to say with 2023 now behind us.
因此,展望 2024 年及以後,我想說 2023 年已經過去了。
We intend to build upon our successes, learned from our disappointments and drive towards a successful 2024 in the second chapter of our new journey post pandemic over the next two seasons.
我們打算在成功的基礎上再接再厲,從失望中汲取教訓,並在未來兩個賽季的疫情後新征程的第二章中推動 2024 年取得成功。
Our focus will be on share growth in the COVID market, further streamlining our business model and preparing the market for a successful launch of our combination vaccine which we anticipate in 2026 when achieved the launch of our combination vaccine will mark our third and potentially most exciting chapter yet post pandemic, allowing us to expand beyond one for one product company when combined with the potential for both organic and inorganic product expansion.
我們的重點將是在新冠病毒市場中的份額增長,進一步簡化我們的業務模式,並為我們的組合疫苗的成功推出做好市場準備,我們預計在2026 年實現這一目標,屆時我們的組合疫苗的推出將標誌著我們的第三個,也可能是最令人興奮的大流行後的又一章,結合有機和無機產品擴張的潛力,使我們能夠超越一對一產品公司的擴張。
This further supports our vision of becoming a leading global vaccine innovator.
這進一步支持了我們成為全球領先的疫苗創新者的願景。
Filip will give an update on our combination program shortly through the course of this presentation.
菲利普將在本次演示過程中很快介紹我們的組合計劃的最新情況。
Before handing it over to the rest of the management team, I wanted to outline our three main priorities for 2024.
在將其交給管理團隊其他成員之前,我想先概述我們 2024 年的三個主要優先事項。
So please turn to Slide 5.
所以請翻到幻燈片 5。
Our first priority is to deliver an updated product for the 24 25 full vaccination season with a more competitive presentation, broader retail availability and early avail or availability in the market with the goal of capturing increased share.
我們的首要任務是為 24 25 整個疫苗接種季節提供更新的產品,提供更具競爭力的展示、更廣泛的零售可用性以及市場上的早期可用性或可用性,以獲取更多份額。
Our second priority is to independently launch the Phase three trial of our COVID flu combination vaccine product and showcase more of what our scientific platform is capable of through the generation and sharing of new clinical data.
我們的第二個優先事項是獨立啟動我們的新冠流感聯合疫苗產品的三期試驗,並透過產生和共享新的臨床數據來更多地展示我們的科學平台的能力。
Finally, our third priority is to continue the evolution of Novavax with our eyes firmly on the future opportunity, further reducing our operating expenses and enhancing our processes and while maintaining our capabilities so we can deliver on our intended business objectives.
最後,我們的第三個優先事項是繼續 Novavax 的發展,堅定地專注於未來的機會,進一步減少我們的營運費用並增強我們的流程,同時保持我們的能力,以便我們能夠實現我們的預期業務目標。
We are excited about the prospects ahead of us as we enter the second chapter of our post-pandemic journey.
當我們進入大流行後旅程的第二章時,我們對未來的前景感到興奮。
Our base plans should we succeed in executing them in 24 and 25 promise to place Novavax in a stronger leader position, ready to launch our new combination vaccine and accelerate the Company towards profitability and significant growth potential.
如果我們在 24 和 25 天內成功執行我們的基本計劃,我們將承諾使 Novavax 處於更強大的領導地位,準備推出我們的新組合疫苗,並加速公司實現盈利和巨大的成長潛力。
Now I would like to hand it over to additional members of the team to discuss our results from the quarter in more detail, beginning with John Trizzino for our commercial updates.
現在,我想將其交給團隊的其他成員,以更詳細地討論我們本季度的業績,首先是約翰·特里齊諾 (John Trizzino) 的商業更新。
John.
約翰。
John Trizzino - President, COO
John Trizzino - President, COO
Thank you, John.
謝謝你,約翰。
Please turn to Slide 6.
請翻到幻燈片 6。
As John explained, 2023 was a year of significant change for our business, and we have learned many lessons that are allowing us to better position ourselves for a stronger 24 25 COVID vaccination season.
正如約翰所解釋的,2023 年是我們業務發生重大變化的一年,我們吸取了許多經驗教訓,使我們能夠更好地為 24 25 新冠疫苗接種季做好準備。
I'd like to focus today's update on how we plan to translate these lessons into action with a goal to grow share in each of our key regions as well as the changes we've made to our commercial strategy.
我想在今天的更新中重點介紹我們計劃如何將這些經驗教訓轉化為行動,以增加我們在每個關鍵地區的份額以及我們對商業策略所做的改變。
Please turn to Slide 7.
請翻到幻燈片 7。
First, I'd like to provide some high-level context on 2023 and the opportunities in 2024.
首先,我想提供一些有關 2023 年和 2024 年機會的概要背景。
Full year 2023 product sales were $531 million, which includes $251 million in the fourth quarter.
2023 年全年產品銷售額為 5.31 億美元,其中第四季為 2.51 億美元。
Over 90% of that came from APAC sales from Europe, Australia and New Zealand with the remainder of our product sales in the US, Canada, Singapore, Korea and Taiwan markets.
其中超過 90% 來自歐洲、澳洲和紐西蘭的亞太地區銷售,其餘產品則銷售在美國、加拿大、新加坡、韓國和台灣市場。
Importantly, we entered 2024 with over $1 billion outstanding and expected APA contract value with deliveries planned for 2024 through 2026 for 2024 our XBB. remaining product sales include Q Q1, APA deliveries for Europe and then for the southern hemisphere and APA sales to Australia and New Zealand upon regulatory approval.
重要的是,進入 2024 年,我們的未完成和預期 APA 合約價值超過 10 億美元,計劃在 2024 年至 2026 年交付我們的 XBB。其餘產品銷售包括第一季、歐洲和南半球的 APA 交付以及經監管部門批准後向澳洲和紐西蘭的 APA 銷售。
We also see incremental opportunity for the private credit market this year in the UK as well as the potential for CDC. to recommend an additional spring time dose for individuals 65, and over on which ACIP. is meeting to discuss today.
我們也看到今年英國私人信貸市場的增量機會以及 CDC 的潛力。建議 65 歲及以上的人在春季額外注射 ACIP 劑量。今天開會討論。
Please turn to Slide 8.
請翻到幻燈片 8。
As John mentioned earlier, we learned a lot in 2023, which was our 1st year competing in a dynamic post pandemic US commercial market, we successfully secured regulatory authorization and approval for our updated vaccine in key markets around the world and made significant deliveries under our APA agreements in the US.
正如約翰之前提到的,我們在2023 年學到了很多東西,這是我們在大流行後充滿活力的美國商業市場競爭的第一年,我們成功地在全球主要市場獲得了監管機構授權和批准我們的更新疫苗,並在我們的指導下進行了大量交付。美國的 APA 協議。
Several factors related to our five dose product presentation and timing to market entry impacted our ability to gain market share.
與我們的五劑產品展示和進入市場時機相關的幾個因素影響了我們獲得市場份額的能力。
However, factors outside of our control, namely the disappointing COVID market size at just over 30 million doses and the fact that the retail channel accounted for over 95% of vaccinations also led to U.S. performance below our expectations.
然而,我們無法控制的因素,即令人失望的新冠病毒市場規模僅超過 3,000 萬劑,以及零售通路佔疫苗接種量的 95% 以上,也導緻美國的表現低於我們的預期。
We continue to believe that the US market holds opportunity for Novavax in the US.
我們仍然相信美國市場為 Novavax 在美國帶來機會。
We achieved some important milestones that should provide an opportunity for a much better performance in 2024.
我們實現了一些重要的里程碑,這些里程碑應該為 2024 年取得更好的業績提供機會。
We built significant levels of awareness for the first time in the US market over 80% aided awareness and have seen pockets of rapid uptake, whereas some retail outlets, we saw up to 10% share when we were carried on an even playing field.
我們首次在美國市場建立了超過 80% 的顯著認知度,並看到了一些快速普及,而在一些零售店,當我們處於公平的競爭環境中時,我們看到了高達 10% 的份額。
Regarding pharmacy processes and availability for 2024.
關於 2024 年的藥房流程和可用性。
We are focused on being in market in early September, which we anticipate as the start of the vaccination season.
我們的重點是在九月初上市,預計這將是疫苗接種季節的開始。
We also intend to offer our vaccination in a prefilled syringe.
我們也打算透過預充填注射器提供疫苗接種。
And if approved, under full BLA licensure, we know that in the first post-pandemic season, COVID vaccinations overwhelmingly took place in pharmacies.
如果獲得批准,在 BLA 的完全許可下,我們知道在大流行後的第一個季節,絕大多數新冠疫苗接種都是在藥房進行的。
So we have recalibrated and streamlined our customer engagement teams to focus on this channel.
因此,我們重新調整和精簡了我們的客戶參與團隊,以專注於這個管道。
Today, we are already leveraging the relationships built this past season and our currently at the negotiating table with the top major retailers who drove 90% of the pharmacy business last season, potentially setting the stage for expanded access to our updated vaccine in the top national and regional retail chains.
今天,我們已經在利用上個季度建立的關係,以及目前與頂級主要零售商的談判桌,這些零售商推動了上個季度90% 的藥品業務,這可能為擴大在全國頂級零售商中獲得我們的更新疫苗奠定基礎。和區域零售連鎖店。
Additionally, we believe that if we achieve early September delivery, a prefilled syringe and BLA approval, we can secure a meaningfully improved market share.
此外,我們相信,如果我們在 9 月初實現交付、預充式註射器並獲得 BLA 批准,我們就能確保市場份額得到顯著提高。
We especially see opportunity in the 65 plus segment, which had the highest rates of vaccination rates of 42% last season.
我們尤其看到了 65 歲以上族群的機會,上一季該族群的疫苗接種率最高,達 42%。
And this is where we plan to concentrate our promotional spend in an effort to convert that market to Novavax vaccine shots in arms.
這就是我們計劃集中促銷支出的地方,努力將該市場轉變為注射 Novavax 疫苗。
We are also closely watching the ACIP meeting today, which will potentially result in a recommendation for spring vaccination for high-risk groups, including those over 65 and increased opportunity to benefit from our updated vaccine.
我們也正在密切關註今天的 ACIP 會議,該會議可能會提出針對高風險族群(包括 65 歲以上)春季接種疫苗的建議,並增加從我們更新的疫苗中受益的機會。
Finally, we are also making important progress on our objective of on-time delivery.
最後,我們在按時交貨的目標方面也取得了重要進展。
We are working closely with the FDA on a rolling submission of our BLA.
我們正在與 FDA 密切合作,滾動提交 BLA。
Please turn to Slide 9.
請翻到投影片 9。
Now let's talk about markets outside the US starting with Europe, which converge to a commercial market this year for the first time, our APA in the European Commission ended in 2023, and we are now entering, for the first time a commercial market opportunity and which despite strong competitive pressure from MRNA.'s APA's, we see revenue potential for our new vaccine vaccine in Italy, Spain and France, as well as in the UK.
現在讓我們談談美國以外的市場,從歐洲開始,今年首次向商業市場融合,我們在歐盟委員會的 APA 於 2023 年結束,我們現在正在首次進入商業市場機會,儘管來自MRNA. 的APA 的強大競爭壓力,我們仍看到我們的新疫苗在義大利、西班牙和法國以及英國的收入潛力。
In these markets, our focus will be on delivering a single dose presentation with timely availability in the UK, we are planning for the launch of a private market featuring new accident.
在這些市場中,我們的重點將是在英國及時提供單劑量演示,我們正在計劃推出一個以新事故為特色的私人市場。
The health security agency recently updated its green book to include our vaccine and discussions are underway with leading retailers and occupational health providers.
衛生安全機構最近更新了其綠皮書,將我們的疫苗納入其中,並且正在與領先的零售商和職業健康提供者進行討論。
We are already seeing interest in potential orders for our new vaccine.
我們已經看到了對我們新疫苗的潛在訂單的興趣。
The vaccine Finally, Asia Pacific remains an opportunity for us for the next two seasons through the expected deliveries under existing APAs.
最後,透過現有 APA 下的預期交付,亞太地區仍然是我們未來兩個季節的機會。
Overall, our commercial efforts in Asia-Pacific remain focused on Australia and our largest APA global market, as well as New Zealand, Singapore and Taiwan.
總體而言,我們在亞太地區的商業努力仍然集中在澳洲和我們最大的 APA 全球市場,以及紐西蘭、新加坡和台灣。
We expect approval of our updated vaccine in Australia and New Zealand soon.
我們預計我們的更新疫苗很快就會在澳洲和紐西蘭獲得批准。
Finally, in Canada, we continue to execute on our APIR. efforts are focused on securing nasty recommendation on par with MRI days and driving awareness of our differentiated vaccine with health care providers and consumers.
最後,在加拿大,我們繼續執行 APIR。我們的努力重點是確保與 MRI 天數相當的不良推薦,並提高醫療保健提供者和消費者對我們差異化疫苗的認識。
Now please turn to Slide 10.
現在請翻到投影片 10。
As John noted, we have made significant changes to our organization to how we work towards scope and scale and how we are working tirelessly to coordinate the many critical activities needed to be ready for a successful fall season across all key areas from CMC.
正如約翰所指出的那樣,我們對我們的組織進行了重大改變,改變了我們如何努力實現範圍和規模,以及我們如何不懈努力協調為 CMC 所有關鍵領域成功秋季做好準備所需的許多關鍵活動。
Through regulatory to our commercial efforts, we are coordinating our workflows and streamlining our processes and remain singularly focused on operational execution for the upcoming 24 25 season in all of our key markets, we continue to believe and our data indicates that there is significant demand for Novavax's protein-based vaccine and that new vaccines will play a meaningful role across the U.S., Europe and the rest of the world as we focus on the future.
透過對我們的商業工作進行監管,我們正在協調我們的工作流程並簡化我們的流程,並繼續專注於我們所有主要市場即將到來的 24 25 季節的運營執行,我們仍然相信並且我們的數據表明,對Novavax 的蛋白質疫苗和新疫苗將在我們著眼於未來的過程中在美國、歐洲和世界其他地區發揮有意義的作用。
We expect continued transformation in our business with commercial product sales continuing to grow and to contribute to Novavax's total revenue mix over the next two seasons.
我們預計我們的業務將持續轉型,商業產品銷售將持續成長,並為 Novavax 未來兩季的總收入組合做出貢獻。
As the pandemic era APA sales agreements mature and reach their conclusion between now and 2026.
隨著大流行時代 APA 銷售協議的成熟並從現在到 2026 年達成。
We believe that the market is migrating towards seasonal combination, respiratory vaccines, especially for flu and COVID.
我們認為,市場正在轉向季節性組合呼吸道疫苗,尤其是流感和新冠疫苗。
Our market research shows that over half of the flu market is anticipated to convert to combination products and that 25% to 30% of health care providers and consumers prefer a protein-based option.
我們的市場研究表明,預計超過一半的流感市場將轉向組合產品,25% 至 30% 的醫療保健提供者和消費者更喜歡基於蛋白質的選擇。
And to date, we believe we are ahead of other non mRNA competition in combo product development.
迄今為止,我們相信我們在組合產品開發方面領先其他非 mRNA 競爭對手。
We think we are well positioned to capture our fair share of that market opportunity by bringing together our technology platform matrix, imagine proven COVID vaccine and an outstanding flu vaccine candidate with positive Phase three data to discuss this and other key R&D updates I would like to hand it over to Filip.
我們認為,透過將我們的技術平台矩陣、經過驗證的新冠疫苗和具有積極第三階段數據的傑出流感候選疫苗結合在一起,我們有能力抓住我們公平的市場機會,以討論這一點和其他關鍵的研發更新。把它交給菲利普。
Filip Dubovsky - President, Research & Development
Filip Dubovsky - President, Research & Development
Thanks, John.
謝謝,約翰。
Please turn to slide 11 and 12.
請翻至投影片 11 和 12。
I want to cover two R&D priorities for 2024.
我想談談 2024 年的兩個研發重點。
The first priority is the delivery of updated variant vaccines.
當務之急是提供更新的變異疫苗。
I illustrate clinical and real-world evidence about the performance of our XBB. containing vaccine.
我闡述了有關 XBB 表現的臨床和現實證據。含有疫苗。
Before I update you on our approach for 24 25 seasons.
在我向您介紹我們 24 至 25 個賽季的最新情況之前。
Our second priority is launching the next phase of our COVID influenza combination program.
我們的第二個優先事項是啟動下一階段的新冠流感聯合計劃。
Like John said, the program is on track, and we have received FDA guidance of how to achieve accelerated approval.
正如約翰所說,該計劃正在步入正軌,我們已經收到 FDA 關於如何實現加速批准的指導。
Before I move into my slides, I want to reflect on the data we have accumulated over this past year and they continue to support the promise of our nanoparticle and management technology.
在開始幻燈片之前,我想回顧一下我們在過去一年中累積的數據,它們繼續支持我們對奈米顆粒和管理技術的承諾。
We continue to see broad, long-lived immune responses in our clinical studies while maintaining a favorable reactogenicity profile.
我們在臨床研究中繼續看到廣泛、持久的免疫反應,同時保持良好的反應原性。
And this has proven to be true for our initial COVID vaccine, our XCB. one five vaccine, the R2 and on malaria vaccine as well as our experimental COVID influence of combination vaccine.
事實證明,這對我們最初的新冠疫苗 XCB 來說是正確的。一五疫苗、R2和瘧疾疫苗以及我們實驗性的新冠疫苗聯合疫苗的影響。
And we've also started to accumulate real-world effectiveness data that shows the immune responses seen in our studies translate to disease prevention in the real world fail.
我們也開始累積現實世界的有效性數據,這些數據表明我們研究中看到的免疫反應轉化為現實世界中的疾病預防失敗。
Let's move to slide 13 and review where we are with straight chain.
讓我們轉到幻燈片 13 並回顧直鏈的情況。
Starting with a summary of last year's update.
首先對去年的更新進行總結。
Last summer, the strain was updated to actually be one five, and we ran a clinical study to reconfirm our strain change approach and evaluate the vaccine's performance.
去年夏天,病毒株實際上更新為一五,我們進行了一項臨床研究,以重新確認我們的病毒株改變方法並評估疫苗的性能。
Vaccine achieved its co-primary endpoint of inducing robust actually be one five neutralization.
疫苗實現了其誘導強效的共同主要終點實際上是五分之一的中和。
And so conversion responses from the left hand side of the slide are neutralization responses in adults who PROVE-IT previously received three or more mRNA vaccines.
因此,幻燈片左側的轉換反應是先前接受過三種或更多 mRNA 疫苗的 PROVE-IT 成年人的中和反應。
As you know, we've won five responses, increased sevenfold with a single boosting dose.
如您所知,我們已經贏得了五次回應,單次加強劑量使反應增加了七倍。
Also displayed are the neutralization responses to J. one, which is currently the most common circulating variants.
也顯示了對 J. 1 的中和反應,J. 1 是目前最常見的流行變種。
As you can see, we had a 5.6% response to this forward drift variant once again, demonstrating this vaccine technology can induce broadly neutralizing responses.
正如您所看到的,我們再次對這種前向漂移變體產生了 5.6% 的反應,這表明這種疫苗技術可以誘導廣泛的中和反應。
Now on the right hand side of the slide, our local and systemic data-driven see symptoms.
現在,在幻燈片的右側,我們的本地和系統數據驅動看到了症狀。
Despite the study subjects having received a minimum of three prior doses of mRNA vaccine.
儘管研究對象之前至少接受過三劑 mRNA 疫苗。
Our tolerability profile was very favorable, and this has been reported multiple times in academic publications.
我們的耐受性非常良好,學術出版物已多次報告這一點。
Okay.
好的。
Let's go to slide 14, which depicts how these immune responses translate into clinical effectiveness.
讓我們來看看投影片 14,它描述了這些免疫反應如何轉化為臨床效果。
On February first, the CDC published early season COVID vaccine effectiveness estimates.
2 月 1 日,疾病預防控制中心 (CDC) 發布了早期新冠疫苗有效性估計。
They concluded that the overall adjusted vaccine effectiveness of the three vaccine brands combined was 54%, and that included protection against Gen one, which was estimated to account for about 39% of the symptomatic cases.
他們得出的結論是,三個疫苗品牌的整體調整後疫苗有效性為 54%,其中包括對第一代疫苗的保護,估計約佔有症狀病例的 39%。
Effectiveness was not calculated by vaccine manufacturer or platform for the vaccine.
疫苗製造商或疫苗平台並未計算有效性。
Specific case counts were included in publication and are depicted on the right hand side of this slide.
具體病例數已包含在出版物中,並在本投影片的右側進行了描述。
This appears favorable for Novavax.
這似乎對 Novavax 有利。
So just some factors are not available.
所以只有一些因素不可用。
So individual vaccine effectiveness cannot be calculated.
因此無法計算個體疫苗的有效性。
Although this part of the study captures a small number of Novavax cases, we count those accrued relative rate reduction for our vaccine, which was 75% imbalance in the case counts.
儘管這部分研究僅捕獲了一小部分 Novavax 病例,但我們計算了我們的疫苗累積的相對率下降情況,病例數中有 75% 的不平衡。
And the relative rate reduction gives us confidence our vaccine is providing protection state.
相對率的降低讓我們相信我們的疫苗正在提供保護狀態。
Let's go slide 15.
讓我們看投影片 15。
For this year's variant.
對於今年的變體。
Gen-1 is causing the vast majority of diseases globally, including in the US is depicted on the left hand side in purple dots is a recombinant protein vaccine company, we make many of the variance and cross system against each other.
Gen-1 正在導致全球絕大多數疾病,包括在美國,如左側紫點所示,是一家重組蛋白疫苗公司,我們製造了許多差異和交叉系統,相互對抗。
On the right hand side of the slide is antigenic photography depicting the imaging distance between XPB. one five and J. one, which is over four antigenic units and represents over 16 fold reduction immune responses, despite the fact that showed you data that HBV vaccine induces good immune responses and those translate into real or protection from the CDC publication.
幻燈片右側是抗原攝影,描繪了 XPB 之間的成像距離。 1 5 和 J. 1,超過 4 個抗原單位,代表免疫反應減少超過 16 倍,儘管事實上有數據表明 HBV 疫苗誘導良好的免疫反應,並且這些數據轉化為真實的或來自 CDC 出版物的保護。
We believe it is appropriate to update the vaccine to protect from future drift variance.
我們認為更新疫苗以防止未來的漂移變化是適當的。
Berry will narrow the antigenic distance and should future proof the vaccine effectiveness when subsequent mutations occur.
貝瑞將縮小抗原距離,並在未來發生後續突變時證明疫苗的有效性。
Therefore, we would advance Gen one into commercial manufacture while continuing to evaluate upcoming variants.
因此,我們將把第一代推進到商業製造,同時繼續評估即將推出的變體。
Okay.
好的。
Let's go to Slide 16 for a brief update of our COVID influences combination program.
讓我們轉到投影片 16,了解我們的新冠疫情影響組合計畫的簡要更新。
We've been interacting with the FDA on the design of our Phase three program and the accelerated regulatory approval pathway.
我們一直在與 FDA 就第三階段計劃的設計和加速監管審批途徑進行互動。
We have agreement on the study design, study endpoints, travel comparators and size of licensure enabling safety database.
我們就研究設計、研究終點、旅行比較器和安全資料庫許可規模達成協議。
We're still on track to initiate the Phase three study in the fall.
我們仍有望在秋季啟動第三階段研究。
Patients supportive data from our Phase two study, which is shown on the right hand side of this slide, we have confidence in achieving the agreed-upon endpoints study is designed to compare the immune responses into age groups 50 to 65 and greater than 65 to licensed agent recommended influenza vaccines as well as our own COVID vaccine.
來自我們第二階段研究的患者支持數據(如本幻燈片右側所示),我們有信心實現商定的終點。研究旨在比較 50 至 65 歲年齡組和 65 歲以上年齡組的免疫反應。授權代理商推薦流感疫苗以及我們自己的新冠疫苗。
The granting of accelerated approval will occur after the data is reviewed by FDA and meaningful therapeutic benefit is demonstrated.
FDA 審查數據並證明有意義的治療益處後,將給予加速批准。
We're also planning a lot-to-lot consistency study in the fourth quarter of the year, which will enable a regulatory filing in 2025 and potential launch in the 2026 season.
我們還計劃在今年第四季進行批次間一致性研究,這將使我們能夠在 2025 年進行監管備案,並可能在 2026 年季節推出。
Okay.
好的。
Let me hand over to Jim for a financial update.
讓我向吉姆報告最新的財務狀況。
Jim Kelly - EVP, CFO, and Treasurer
Jim Kelly - EVP, CFO, and Treasurer
Thank you, Filip.
謝謝你,菲利普。
Please turn to Slide 17.
請翻到投影片 17。
This morning, we announced our financial results for the fourth quarter and full year 2023.
今天早上,我們公佈了 2023 年第四季和全年的財務表現。
Details of our results can be found in our press release issued today and in our 10 K filing.
有關我們結果的詳細信息,請參閱今天發布的新聞稿和 10 K 備案文件。
Please turn to Slide 18.
請翻到幻燈片 18。
We are focused on improving the financial health and performance of Novavax to enable long-term value creation towards that goal.
我們專注於改善 Novavax 的財務狀況和業績,以實現長期價值創造以實現這一目標。
I'll share a few of the key themes for 2023 and a look towards 2024 and beyond.
我將分享 2023 年的一些關鍵主題以及對 2024 年及以後的展望。
For the full year 2023, Novavax recorded total revenue of $1 billion and significantly improved our balance sheet profile by reducing current liabilities by $825 million.
2023 年全年,Novavax 的總收入為 10 億美元,並透過減少 8.25 億美元的流動負債,顯著改善了我們的資產負債表狀況。
In addition, the Gavi settlement announced last week removes the risk of arbitration with Gavi and will further reduce short-term liabilities by over $500 million.
此外,上周宣布的Gavi和解協議消除了與Gavi進行仲裁的風險,並將進一步減少超過5億美元的短期負債。
As we continue to transform Novavax into a more lean and agile organization, we reduced 2023 total operating expenses by $1.1 billion or 41% and exceeded our savings targets for R&D plus SG&A by $150 million.
隨著我們繼續將 Novavax 轉型為更精簡和敏捷的組織,我們將 2023 年總營運支出減少了 11 億美元(即 41%),並超出了研發加 SG&A 的節省目標 1.5 億美元。
As we look to 2024, we are targeting R&D and SG&A expenses of between $700 million and $800 million dollars, with the intent to drive them below $750 million midpoint if possible as we continue to resize our organization.
展望 2024 年,我們的目標是研發和銷售及管理費用在 7 億至 8 億美元之間,並希望在我們繼續調整組織規模的同時,盡可能將其降至 7.5 億美元的中點以下。
We ended 2023 with cash and cash receivable of $881 million.
截至 2023 年,我們的現金和應收現金為 8.81 億美元。
In addition, as we enter 2024, we have over $1 billion in PA contract value outstanding with expected deliveries over the next three years.
此外,隨著我們進入 2024 年,我們還有超過 10 億美元的未完成 PA 合同,預計在未來三年內交付。
We believe this positions us well as we focus our investments to establish new commercial COVID markets and advance our kit program.
我們相信,這使我們處於有利地位,因為我們將投資集中於建立新的商業新冠市場並推進我們的試劑盒計劃。
Please turn to Slide 19.
請翻到投影片 19。
Turning to a more detailed view of our 2023 financial results.
更詳細地了解我們 2023 年的財務表現。
I will provide commentary on our fourth quarter 2023 financial results with specific focus on revenue and COGS.
我將對我們 2023 年第四季的財務表現發表評論,特別關注收入和銷貨成本。
For the fourth quarter of 2023, we recorded total revenue of $291 million compared to $357 million in the same period in 2022.
2023 年第四季度,我們的總營收為 2.91 億美元,而 2022 年同期為 3.57 億美元。
Our product sales of $251 million in the fourth quarter of 2023 were primarily related to API deliveries to Europe and Canada plus commercial market product sales in the US, South Korea and Taiwan.
2023 年第四季度,我們的產品銷售額為 2.51 億美元,主要與向歐洲和加拿大交付的 API 以及美國、韓國和台灣的商業市場產品銷售有關。
Grants of $38 million for the fourth quarter of 2023 reflect the realization of the full value of the $1.8 billion U.S. government funding agreements.
2023 年第四季的 3,800 萬美元補助反映了 18 億美元美國政府資助協議的全部價值的實現。
For the full year 2023, our total revenue of $984 million was consistent with our guidance.
2023 年全年,我們的總收入為 9.84 億美元,與我們的指導一致。
In the US market ,product sales for the 2324 vaccination season are now expected to come in below $25 million, which is less than our prior target.
在美國市場,2324疫苗接種季的產品銷售額目前預計將低於2,500萬美元,低於我們先前的目標。
That said, we are closely monitoring the potential for the CDC to recommend a spring COVID-19 booster, and we'll assess how that could impact demand and potential sales in the first half of 2024.
也就是說,我們正在密切關注 CDC 推薦春季 COVID-19 加強劑的可能性,並將評估這將如何影響 2024 年上半年的需求和潛在銷售。
Our cost of sales for the fourth quarter of 2023 were $155 million as compared to $182 million in the same period in 2022.
2023 年第四季的銷售成本為 1.55 億美元,而 2022 年同期為 1.82 億美元。
These periods include $30 million and $99 million, respectively, related to excess obsolete or expired inventory and losses on firm purchase commitments under third party supply agreements.
這些期間分別包括 3000 萬美元和 9900 萬美元,與過多的過時或過期庫存以及第三方供應協議下的確定採購承諾的損失有關。
Please turn to Slide 20.
請翻到投影片 20。
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。
Over the past year, we've reduced our workforce by over 30% compared to the first quarter of 2023.
在過去的一年裡,與 2023 年第一季相比,我們的員工人數減少了 30% 以上。
We have also reduced our full year 2023 R&D and SG&A by over $500 million compared to the full year 2022.
與 2022 年全年相比,我們也減少了 2023 年全年研發和銷售、一般管理費用超過 5 億美元。
This result was approximately $150 million better than our original target.
這一結果比我們最初的目標高出約 1.5 億美元。
And we did so while maintaining core business capabilities and progressing our combination vaccine programs.
我們在這樣做的同時保持了核心業務能力並推進了我們的組合疫苗項目。
For 2024, we are targeting combined R&D and SG&A expenses of $700 million to $800 million.
2024 年,我們的目標是研發和銷售及管理費用合計為 7 億至 8 億美元。
In addition, we are prioritizing improvements to our long-term supply chain efficiency including exploring the sale of our Czech Republic manufacturing facility.
此外,我們正在優先考慮提高我們的長期供應鏈效率,包括探索出售我們的捷克共和國製造工廠。
Please turn to Slide 21.
請翻到投影片 21。
I'd like to discuss progress on our balance sheet and liability management.
我想討論一下我們的資產負債表和負債管理的進展。
During 2023 we reduced the Company's current liabilities by $825 million.
2023 年,我們將公司的流動負債減少了 8.25 億美元。
With the with the recently announced Gavi settlement, we will further reduce current liabilities by over $500 million in 2024.
隨著最近宣布的 Gavi 和解協議,我們將在 2024 年進一步減少超過 5 億美元的流動負債。
Of note, the Gabby settlement provides for an equitable resolution of our differences and spreads any remaining liabilities over five years, allowing us to better manage cash flows and make appropriate investments to grow our business when assessed on a present value and cost of capital basis, we estimate that the cost of the settlement to be in the range of $300 million to $400 million.
值得注意的是,加比和解協議為我們的分歧提供了公平的解決方案,並將任何剩餘負債分攤到五年內,使我們能夠更好地管理現金流,並在根據現值和資本成本進行評估時進行適當的投資以發展我們的業務,我們估計和解費用在3億至4億美元之間。
Please turn to Slide 22.
請翻到投影片 22。
Now turning to financial guidance with an emphasis on our total revenue for the full year 2024, we expect to achieve total revenue of between $800 million and $1 billion.
現在轉向財務指導,重點關注 2024 年全年的總收入,我們預計總收入將達到 8 億至 10 億美元。
Our projected total revenue includes $500 million to $600 million of APA sales based on expected dose delivery schedules and non APA related revenue of $300 million to $400 million from a combination of commercial market product sales, plus royalties and other revenue from our partner related activities.
我們預期的總收入包括基於預期劑量輸送計劃的5 億至6 億美元APA 銷售收入,以及來自商業市場產品銷售的3 億至4 億美元非APA 相關收入,加上特許權使用費和來自我們合作夥伴相關活動的其他收入。
We have previously guided to first quarter 2024 expected total revenues of approximately $300 million.
我們先前預期 2024 年第一季的總營收約為 3 億美元。
Based upon a delay to our Australia XPB regulatory review, we now expect APA sales for both Australia and New Zealand originally anticipated for the first quarter of 2024 to now occur later in 2024.
由於澳洲 XPB 監管審查的延遲,我們現在預計澳洲和紐西蘭的 APA 銷售原本預計在 2024 年第一季進行,現在將在 2024 年稍後進行。
Upon their respective authorizations.
經各自授權。
As a result, our first quarter 2024total revenue is now expected to be approximately $100 million.
因此,我們 2024 年第一季的總營收預計約為 1 億美元。
If successful in achieving the guidance outlined today, we believe this will support the funding of our operations for the next 12 months.
如果成功實現今天概述的指導,我們相信這將為我們未來 12 個月的營運提供資金支持。
In our 10 K filing, you will see that we have provided an update on our going concern disclosure specifically that this forecast continues to be subject to significant uncertainty related to revenue for the next 12 months.
在我們的 10 K 文件中,您會看到我們提供了持續經營披露的最新信息,特別是該預測繼續受到與未來 12 個月收入相關的重大不確定性的影響。
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。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, Jin.
謝謝你,金。
Please turn to Slide 23.
請翻到投影片 23。
I am proud of the progress we made in 2023 and the opportunities we have identified that should help us to build a stronger business with our key priorities of executing on the 24 25 COVID season, advancing our combination vaccine and creating a more financially stable organization.
我對我們在2023 年取得的進展以及我們發現的機會感到自豪,這些機會將幫助我們建立更強大的業務,並在24 25 新冠病毒季節執行我們的關鍵優先事項,推進我們的聯合疫苗並創建一個財務更加穩定的組織。
We are operating a business in a complex and challenging marketplace, which is undergoing significant change, but which also offers immense opportunity to positively impact global public health and drive significant value creation in the future.
我們在一個複雜且充滿挑戰的市場中開展業務,該市場正在經歷重大變化,但也提供了巨大的機會,可以積極影響全球公共衛生並推動未來創造重大價值。
I would like to thank all of our employees and their continued work in advancing our business together, we remain committed to generating successful performance and value creation for all of our stakeholders.
我要感謝我們所有的員工以及他們為共同推進我們的業務所做的持續努力,我們仍然致力於為所有利害關係人創造成功的績效和價值。
And with that, we will now take your questions.
現在我們將回答你們的問題。
Operator
Operator
Roger Song, Jefferies.
羅傑·宋,杰弗里斯。
Roger Song - Analyst
Roger Song - Analyst
Great, and good morning, everyone, and thanks for the update and taking our questions.
太好了,大家早安,感謝您更新並回答我們的問題。
Maybe start with a few clarification for the guidance ask.
也許首先對指導要求做一些澄清。
First is the 1Q $100 million.
首先是第一季的 1 億美元。
So given this is not coming from Australia and New Zealand.
鑑於這不是來自澳大利亞和紐西蘭。
So can you specify what where what are the countries for those APA?
那麼您能否具體說明這些 APA 的國家有哪些呢?
And then for the rest of the for the entire 2024, $500 million to $600 million APA.
然後,對於整個 2024 年的其餘部分,APA 為 5 億至 6 億美元。
It's coming out of the entire one in MATA. outstanding or a place in the.
它是從 MATA 的整個作品中出來的。傑出還是佔有一席之地的。
My question is, do you expect to see new ATA beyond this $1 billion in the coming years.
我的問題是,您是否期望在未來幾年看到新的 ATA 超過 10 億美元?
If so, where will be those country coming from?
如果是這樣,那些國家將來自哪裡?
The last question relates to the revenue guidance.
最後一個問題涉及收入指導。
Is the $300 million to $400 million APA 2024 for guidance on how much is coming from the U.S. If you can give us some color around that.
2024 年 3 億至 4 億美元的 APA 是否可以指導有多少資金來自美國?如果您能為我們提供一些相關資訊。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, Roger.
謝謝你,羅傑。
Three questions in there.
裡面三個問題。
Jim, do you want to take Roger's first question on the source of $100 million in Q1?
Jim,您想回答 Roger 關於第一季 1 億美元來源的第一個問題嗎?
Jim Kelly - EVP, CFO, and Treasurer
Jim Kelly - EVP, CFO, and Treasurer
Certainly on a Good morning, Roger.
當然是早安,羅傑。
So when we look at our Q1 guidance for 2024 that we just shared of 100 and virtually all of that has in fact, already been shipped.
因此,當我們查看 2024 年第一季的指導時,我們剛剛分享了 100 個,實際上所有這些都已經發貨。
It was on it is APAs to Europe that were delivered in January.
這是一月份向歐洲交付的預約定價安排。
So that is the vast majority of the guidance.
這就是絕大多數指導。
As you referenced, our prior guidance for the first quarter of approximately $300 million did include expected sales to Australia and New Zealand.
正如您所提到的,我們之前對第一季約 3 億美元的指引確實包括對澳洲和紐西蘭的預期銷售額。
Now as we have shared with you all today on that review of our XBB. dossier is still ongoing and so it is our expectation that upon on authorization that we will make those deliveries, but later this year.
現在,我們今天與大家分享了對 XBB 的評論。檔案仍在進行中,因此我們預計,在獲得授權後,我們將在今年稍後進行交付。
John Jacobs - President and CEO
John Jacobs - President and CEO
Jim, Roger's third question, you may want to address as well.
吉姆,羅傑的第三個問題,你可能也想解決。
Just a breakdown of the non APA revenue and what proportion of that comes from the US if we heard you correctly relative?
只是非 APA 收入的細分,如果我們沒聽錯的話,其中來自美國的比例是多少?
Jim Kelly - EVP, CFO, and Treasurer
Jim Kelly - EVP, CFO, and Treasurer
Exactly, I'm So Roger, on the component of our revenue guidance, and I'll just restate it here.
確切地說,我是羅傑,關於我們收入指導的部分,我將在這裡重申。
The $800 million to $1 billion, midpoin $ 900 million is split between APA sales and not a PA revenue.
8 億至 10 億美元(中間值 9 億美元)由 APA 銷售額和非 PA 收入分配。
You correctly noted $500 million to $600 million, midpoint $550 million for APA.
您正確地指出 APA 為 5 億至 6 億美元,中間值為 5.5 億美元。
Non APA is $300 million to $400 million.
非 APA 為 3 億至 4 億美元。
And within that, we have two primary buckets.
其中,我們有兩個主要的桶子。
One is related to royalty and other revenue.
一是與特許權使用費和其他收入有關。
As you might remember, we have begun to receive some reimbursement related to our 21, and that income or economics would come in the form of both reimbursement of the matrix we manufacture and support of launch and ongoing sales.
您可能還記得,我們已經開始收到與 21 相關的一些報銷,收入或經濟效益將以我們製造的矩陣報銷以及支持發布和持續銷售的形式出現。
And then finally, also a royalty that we could be eligible for upon those commercial sales.
最後,我們還有資格在這些商業銷售中獲得特許權使用費。
That's a single digit royalty so that's a component of it.
這是個位數的版稅,因此它是其中的一部分。
And I would say, frankly, a small component of it in the remaining commercial portion, this is virtually all U.S. Europe, UK, and we have not provided specific breakouts across those.
坦白說,我想說的是,剩餘商業部分的一小部分,這實際上是美國、歐洲、英國的全部,我們還沒有提供這些方面的具體突破。
These are exceptionally important markets for us.
這些對我們來說是異常重要的市場。
How you heard John Trizzino speak a little bit earlier about how we are prioritizing our focus in these markets to establish them this year and in the case of Europe, an important transition year from APA to commercial markets.
您是如何聽到 John Trizzino 早些時候談到我們如何優先關注這些市場的,以在今年建立這些市場,就歐洲而言,這是從 APA 到商業市場的重要過渡年。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, Jim.
謝謝你,吉姆。
And then finally, Roger, the third portion of your question, John Trizzino, perhaps you can answer I believe Roger was asking would we expect after this billion that we noted and remaining a P value to have future APAs in the out years beyond 2026?
最後,羅傑,你問題的第三部分,約翰·特里齊諾(John Trizzino),也許你可以回答我相信羅傑問的是,在我們注意到的這十億美元之後,我們是否會期望在2026 年之後的未來幾年中保持P 值,以擁有未來的APA?
John Trizzino - President, COO
John Trizzino - President, COO
Yes.
是的。
Thanks, John.
謝謝,約翰。
So on APA.s, generally speaking were a function of the pandemic period of time in which we had advanced purchase agreements.
因此,就 APA 而言,一般來說,這是我們提前達成採購協議的疫情時期的函數。
In place as we transition to the commercial market, you're going to see a mix of a normal commercial market as in the US.
當我們過渡到商業市場時,您將看到與美國一樣的正常商業市場的混合。
So payer driven purchases to retailers in Europe it's again, a mix between tenders and private market that we're already seeing in the UK, for example, we're going into private market retail and occupational health.
因此,付款人推動歐洲零售商的購買,這又是我們在英國已經看到的招標和私人市場的混合,例如,我們正在進入私人市場零售和職業健康。
And so there's a mix there of what those purchases will be, the traditional APAs, why themselves down between now and 2026, and then we'll go to then the normal commercial markets.
因此,這些採購將是什麼、傳統的預約定價安排、為什麼從現在到 2026 年它們會下降,然後我們將進入正常的商業市場。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, John.
謝謝你,約翰。
Thank you, Roger.
謝謝你,羅傑。
Roger Song - Analyst
Roger Song - Analyst
Thank you.
謝謝。
Operator
Operator
Eric Joseph, JP Morgan.
艾瑞克‧約瑟夫,摩根大通。
Eric Joseph - Analyst
Eric Joseph - Analyst
Hi, good morning.
早安.
Thanks for taking the questions.
感謝您提出問題。
And all of the Good Morning America.
還有所有的《早安美國》。
As it relates to as it relates to forward guidance, you can hear me okay.
因為它涉及前瞻性指導,所以你可以聽到我的聲音。
John Jacobs - President and CEO
John Jacobs - President and CEO
Okay, we can.
好吧,我們可以。
Good morning.
早安.
Eric Joseph - Analyst
Eric Joseph - Analyst
Morning.
早晨。
So just a clarification question when it comes to U.S. sales this past quarter, there's a $82 million product sales return accrual item that we noticed.
因此,就上個季度的美國銷售額而言,我們注意到有一個 8,200 萬美元的產品銷售退貨應計項目,需要澄清一下。
Can you just help reconcile that with recorded product sales for the full year of around $29 million in the US is the difference there just you know, that has seen growth in net sales and then is there any concentration of those returns by contracted among the your contracted pharmacies?
您能否幫忙調和一下,美國全年記錄的產品銷售額約為 2900 萬美元,您知道,淨銷售額有所增長,那麼這些回報是否集中在您的合約中?簽約藥局?
And then perhaps just one on the development side as it relates to kick in and your expectation of accelerated approval path there.
然後也許只是開發方面的一個,因為它涉及啟動以及您對加速批准路徑的期望。
Can you just sort of clarify what gives you confidence and being able to pursue a sort of a it sounds like in the end approval on the basis of the immunogenicity, just given that there isn't yet an approved reference kit offering in the market?
您能否澄清一下,是什麼給了您信心,並能夠在免疫原性的基礎上尋求某種聽起來像是最終的批准,只是考慮到市場上還沒有批准的參考試劑盒?
Thank you.
謝謝。
John Jacobs - President and CEO
John Jacobs - President and CEO
Right, Jim Kelly, I wanted to take the first part of that question.
是的,吉姆凱利,我想回答這個問題的第一部分。
And then we'll hand it over to Filip to address the question on kiy.
然後我們將把它交給 Filip 來解決 kiy 上的問題。
Jim Kelly - EVP, CFO, and Treasurer
Jim Kelly - EVP, CFO, and Treasurer
Hey, certainly Good morning or so in our feedback today on the US market, what I shared with folks is that for the 2023, 24 season in the US, we're expecting total revenues for the U.S. market to be below $25 million.
嘿,當然早上好,在我們今天對美國市場的反饋中,我與大家分享的是,對於 2023 年 24 季的美國市場,我們預計美國市場的總收入將低於 2500 萬美元。
And we did not break out the specific number for the fourth quarter, but given that that guidance we just gave, you are the vast majority is some is in the fourth quarter as you are looking at what folks will find our 10 K, which is a gross-to-net net roll.
我們沒有透露第四季度的具體數字,但考慮到我們剛剛給出的指導,絕大多數人是在第四季度,因為你正在考慮人們會發現我們的 10 K,即總轉淨額。
What you have identified is that we have a reserve for returns that are embedded within our financials, that numbers are just over $90 million.
您已發現,我們的財務數據中包含了回報儲備金,該數字剛剛超過 9,000 萬美元。
What that means is that we have sales into the channel and those are to our direct purchasers.
這意味著我們的銷售是透過管道進行的,而這些銷售是針對我們的直接購買者的。
They in turn sell to retail establishments.
他們又將產品賣給零售機構。
And then we make an estimate based on on the shots in arms that we have through IQVIA for what may be eligible and we estimate would be eligible for return upon the end of the season.
然後,我們根據透過 IQVIA 獲得的武器注射情況進行估計,了解可能符合條件的人員,並估計在賽季結束時有資格返回。
It is simply an issue and that at this time we will monitor it closely as the year goes on.
這只是一個問題,目前我們將隨著時間的推移密切關注它。
But our net revenue in the case of the United States for the fourth quarter is a function of that return estimate that you're seeing a whole forward financials is net of that amount.
但就美國而言,我們第四季的淨收入是回報估計的函數,您會看到整個遠期財務資料已扣除該金額。
Eric Joseph - Analyst
Eric Joseph - Analyst
Okay, great.
好的,太好了。
That's very helpful.
這非常有幫助。
John Jacobs - President and CEO
John Jacobs - President and CEO
Filip, do you want to take Eric's second question on -- Eric did you have a follow up?
菲利普,你想回答艾瑞克的第二個問題嗎-艾瑞克你有後續行動嗎?
Eric Joseph - Analyst
Eric Joseph - Analyst
No. no. that's fine.
不,不。沒關係。
The follow-up question on the on the development side.
關於開發方面的後續問題。
Filip Dubovsky - President, Research & Development
Filip Dubovsky - President, Research & Development
Yes, we have a couple of lines of evidence to give us confidence.
是的,我們有一些證據可以給我們信心。
I mean, the as you know, we had a prior Phase three study that was actually granted the accelerated approval pathway by the FDA.
我的意思是,正如你所知,我們之前進行了一項三期研究,實際上已獲得 FDA 的加速批准途徑。
So we know what endpoints and how we need to achieve that.
所以我們知道什麼是終點以及如何實現這一點。
And certainly the immune responses that matured in size today would be adequate to achieve the same ones we used in our prior Phase three study.
當然,今天成熟的免疫反應足以實現我們在先前的第三階段研究中使用的相同免疫反應。
We also know the competitors are talking about timelines, which would indicate they're pursuing accelerated approval pathway.
我們也知道競爭對手正在談論時間表,這表明他們正在尋求加速批准途徑。
But I think most importantly, the FDA told us, and so they reviewed our plans in our study.
但我認為最重要的是,FDA 告訴我們,因此他們在我們的研究中審查了我們的計劃。
And what they told us was that if we achieve the agreed-upon endpoints and we are able to demonstrate meaningful therapeutic benefit, then there's a pathway forward to accelerate approval.
他們告訴我們的是,如果我們實現了商定的終點並且能夠證明有意義的治療益處,那麼就有一條加速批准的途徑。
Now they also said they would have to wait to see the data before you took the final determination by the or the strength of the immune responses we're seeing compared to the comparators as well as our experience gives us confidence that we have a pathway forward.
現在他們還表示,在根據我們所看到的免疫反應與比較者相比的強度做出最終決定之前,他們必須等待查看數據,而我們的經驗讓我們相信我們有一條前進的道路。
John Jacobs - President and CEO
John Jacobs - President and CEO
Yes, thank you, Jim and Filip.
是的,謝謝你們,吉姆和菲利普。
Thanks, Eric.
謝謝,埃里克。
Filip Dubovsky - President, Research & Development
Filip Dubovsky - President, Research & Development
Eric, did you have a follow up?
艾瑞克,你有後續行動嗎?
Eric Joseph - Analyst
Eric Joseph - Analyst
One more follow-up, if I could on On and on full year full-year 24 guidance on the non APA portion of that, what to what extent is that guidance sort of conditioned or dependent on additional regulatory approvals or recommendations in the U.S., U.K. and Europe?
還有一個後續問題,如果我可以在全年 24 日關於非 APA 部分的指導,該指導在多大程度上取決於或依賴美國的額外監管批准或建議,英國和歐洲?
John Jacobs - President and CEO
John Jacobs - President and CEO
Yes, Jim, do you want to take that one again?
是的,吉姆,你想再接受一次嗎?
John Trizzino can add color if needed, go ahead.
如果需要,約翰·特里齊諾可以添加顏色,繼續吧。
Jim Kelly - EVP, CFO, and Treasurer
Jim Kelly - EVP, CFO, and Treasurer
Certainly showed the non APA revenue guidance of $300 million to $400 million is virtually all except for that small portion related to our 21 concentrated on the full vaccination season.
當然,除了與我們 21 集中在整個疫苗接種季節相關的一小部分之外,3 億至 4 億美元的非 APA 收入指引實際上是全部。
And so the regulatory authorization.
等等監理授權。
So we'd be supportive of recognizing that that outcome are all linked to our updated variant speed to market and regulatory authorizations to support that commercial market performance.
因此,我們支持認識到這一結果都與我們更新的變體上市速度以及支持商業市場表現的監管授權有關。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, Jim.
謝謝你,吉姆。
Thanks, Eric.
謝謝,埃里克。
Operator
Operator
Brendan Smith, Peter Cohen.
布倫丹·史密斯,彼得·科恩。
Brendan Smith - Analyst
Brendan Smith - Analyst
I'd say I think very much for taking the questions.
我想說我非常願意接受這些問題。
I had a quick one from us.
我從我們那裡得到了一份快速的。
Actually, apologies if I missed it in your comments, but I think you mentioned that you saw up to about 10% share in the US in retail outlets where you are carried on an even playing field.
事實上,如果我在您的評論中錯過了這一點,我深表歉意,但我想您提到您在美國的零售店中看到了大約10% 的份額,在那裡您處於公平的競爭環境中。
Just wondering if you could maybe expand on that a little bit, really kind of what that looks like if there's something about those areas where you could expand even further this year and into next year, maybe what your plans for that would look like?
只是想知道您是否可以對此進行一些擴展,如果您可以在今年和明年進一步擴展這些領域,那麼您的計劃會是什麼樣子?
And then just maybe quickly what kind of the important steps between now and a potential approval would look like if you are to prioritize the prefilled syringe on any meaningful differences you'd expect to that process versus last year?
然後,如果您要根據您預期該流程與去年相比的任何有意義的差異來優先考慮預充式註射器,那麼從現在到潛在批准之間可能會出現什麼樣的重要步驟?
John Jacobs - President and CEO
John Jacobs - President and CEO
John Trizzino do you want to take Brendan's question and maybe discuss what's different in our intentions for 24 versus 23?
John Trizzino 你想回答 Brendan 的問題嗎?或許可以討論一下我們對於 24 小時和 23 小時的意圖有何不同?
John Trizzino - President, COO
John Trizzino - President, COO
Yes, sure.
是的,當然。
So yes, so that was a great example on the 10%.
是的,這對 10% 的人來說是一個很好的例子。
And we also had in the instance where we had a 5.4% to 5% share in similar circumstances.
在類似情況下,我們也有 5.4% 到 5% 的份額。
We as we said, we came to the market a little bit late.
正如我們所說,我們進入市場有點晚了。
So vaccinations we're underway and five dose vial created some challenges.
因此,我們正在進行疫苗接種,五劑小瓶帶來了一些挑戰。
And so as we look forward to this, the benefit of having a well informed of pharmacy population and pharmacists in educated is going to help in that regard on a timely availability of products on prefilled syringe is going to make it much more convenient for use and so as we've mentioned, three critical elements here for success in 24 is early September, on-time availability of product in front of the vaccination season, a BLA, which is in process right now through rolling submission and prefilled syringe, making it easy and convenient use for our performance is we believe that these will make dramatic difference in what we see as our performance in 24.
因此,當我們期待這一點時,充分了解藥房人員和受過教育的藥劑師的好處將有助於在這方面及時提供預充式註射器上的產品,這將使其使用起來更加方便,因此,正如我們所提到的,24 日成功的三個關鍵要素是9 月初、在疫苗接種季節之前準時提供產品、BLA,目前正在通過滾動提交和預裝注射器進行處理,使其成為可能簡單方便地使用我們的表現是我們相信這些將使我們在24 小時中看到的表現產生巨大的變化。
John Jacobs - President and CEO
John Jacobs - President and CEO
And John, just to just a little bit of additional commentary, well said, but I think that 10% per annum that you mentioned and a key retailer.
約翰,只是補充一點評論,說得好,但我認為你提到的每年 10% 是一家重要的零售商。
When we say even playing field, we were still several weeks behind the competition in a five dose vial, and we were able to achieve that in just a few weeks being on the market.
當我們說公平競爭時,我們在五劑量小瓶中仍然落後競爭對手幾週,而我們在上市幾週內就實現了這一目標。
So we're confident that should we should we execute on the plans we intend to execute upon, which include a pretty both syringe and on-time launch in the marketplace being on an even playing field when it comes to the pharmacy schedule that consumers can go in and schedule their shots, which wasn't the case in 2023 in our 1st year in the US market, and we were encouraged by the early dialogue we had starting this past fall with retailers.
因此,我們有信心,我們是否應該執行我們打算執行的計劃,其中包括注射器和按時在市場上推出,在消費者可以使用的藥房時間表方面處於公平的競爭環境中進去安排他們的拍攝時間,而2023 年我們進入美國市場的第一年,情況並非如此,我們對去年秋天開始與零售商進行的早期對話感到鼓舞。
And I think it was a surprise to everyone that the COVID market in the United States was over, like John said in our in our earlier commentary, 95% plus retail, nothing really coming out of the IDNs or the physician offices.
我認為每個人都感到驚訝的是,美國的新冠病毒市場已經結束,就像約翰在我們之前的評論中所說的那樣,95% 以上是零售的,沒有任何真正來自 IDN 或醫生辦公室的結果。
So we've recalibrated reorganized our internal team and our focus on retail started those conversations in the fall.
因此,我們重新調整了內部團隊,我們對零售的關注在秋季開始了這些對話。
We're very encouraged by where those are headed right now.
我們對這些目前的發展方向感到非常鼓舞。
And that makes us more optimistic for it to be much better positioned for success in 24.
這讓我們更加樂觀地認為它能夠在 24 小時內取得更好的成功。
Thank you.
謝謝。
Operator
Operator
Mayank Mamtani, B. Riley Securities.
Mayank Mamtani,B. Riley 證券。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
And revising our thanks for taking the question and appreciate the level of V-Go, including on The Gallery settlement.
並再次感謝您提出問題並欣賞 V-Go 的水平,包括畫廊解決方案。
So maybe just on the current liabilities section by section could be could you just break out beyond Gavi of what what sort of components remain and how they contribute to the influence on a going concern language and maybe just the cash outlays you expect in 2024 specifically new UK, if you could just break that down, that would be great.
因此,也許您可以逐一討論流動負債,超越全球疫苗和免疫聯盟,了解剩下哪些組成部分以及它們如何對持續經營語言產生影響,也許只是您預計 2024 年特別是新的現金支出英國,如果你能把它分解,那就太好了。
And then I have a follow-up.
然後我有一個後續行動。
John Jacobs - President and CEO
John Jacobs - President and CEO
Yes.
是的。
And Jim Kelly will take that, Mike.
吉姆·凱利會接受的,麥克。
And I think for we're very proud that in the past year, we've made a lot of good progress on removing a significant portion of the one-time current liabilities that were legacy of the pandemic and many of the take-or-pay contracts or other matters.
我認為,我們感到非常自豪的是,在過去的一年裡,我們在消除很大一部分一次性流動負債方面取得了很大進展,這些負債是大流行和許多「接受或接受」遺留下來的。支付合約或其他事項。
I'll let Jim Kelley give you more detail on current liability breakdown, Jim?
我會讓吉姆凱利向您提供有關當前負債細目的更多詳細信息,吉姆?
Jim Kelly - EVP, CFO, and Treasurer
Jim Kelly - EVP, CFO, and Treasurer
All right.
好的。
Hey, good morning, Mike.
嘿,早上好,麥克。
And if I'm going to reference Slide 21 from our presentation for listeners.
如果我要引用我們為聽眾示範的投影片 21。
And so as John noted, we were able to knock down current liabilities by $825 million during 2023.
因此,正如 John 指出的那樣,我們能夠在 2023 年期間減少 8.25 億美元的流動負債。
And as we look at the impact of the Gavi settlement, we will be in a position to reduce those liabilities by over $500 million.
當我們考慮 Gavi 和解協議的影響時,我們將能夠將這些負債減少 5 億多美元。
Our balance sheet nets really by spreading the remaining any remaining liability over five years.
我們的資產負債表實際上是透過將剩餘的負債分攤到五年內來實現淨額的。
So we are actually exceptionally pleased on what that means in terms of predictability of cash flow and in marrying that up with our core operating plan.
因此,我們實際上對現金流的可預測性以及將其與我們的核心營運計劃相結合的意義感到非常高興。
And then with respect to liabilities at 12/31/2023, I'll reference a couple couple of spots.
然後,關於 2023 年 12 月 31 日的負債,我將引用幾個地方。
I'll start with the other current liabilities category of $861 million.
我將從其他流動負債類別 8.61 億美元開始。
So within that, it's approximately $700 million related to Gabi.
因此,其中大約有 7 億美元與加比有關。
And so as I just noted, over $500 million of that will move to our long term long term liabilities as we continue to move forward.
正如我剛才指出的,隨著我們繼續前進,其中超過 5 億美元將轉入我們的長期負債。
And then the remaining components of that were there's $112 million related to the U.K. And we've got some other small refund liabilities related to other EPA related matters.
其中剩下的部分是與英國相關的 1.12 億美元,我們還有一些與其他 EPA 相關事宜相關的其他小額退款負債。
Small items and then finally, it's there's a facility operating lease in there as well.
小物品,最後,那裡還有設施經營租賃。
So those are the components of the $861 million.
這些就是 8.61 億美元的組成部分。
With respect to AP and accrued.
關於AP和累計。
When you look at the $527 million.
當你看看 5.27 億美元。
We continue to have our Fuji matter outstanding.
我們的富士問題仍然突出。
I think folks have heard the update.
我想人們已經聽到更新了。
You'll see we are on a track towards a arbitration hearing in May.
您將會看到我們正朝著五月份的仲裁聽證會邁進。
We, of course, on I feel strongly about the merits of our case in a way that with that outcome.
當然,我對我們案件的優點有強烈的感受,因此結果也是如此。
And in addition to that, as we look at the remaining components of a P&L accrued.
除此之外,當我們查看應計損益的其餘組成部分時。
They are part and parcel of primarily of just the standard business operations of the Company.
它們主要是公司標準業務運作的重要組成部分。
And this is one of the things that we're exceptionally proud of as the year has progressed.
隨著這一年的進展,這是我們感到特別自豪的事情之一。
We have increasingly strong, I'll call it cleared the deck of many of these legacy pandemic era manufacturing take-or-pays, and we're moving much more to a traditional streamlined balance sheet of operating entity.
我們已經越來越強大,我稱之為清除了許多傳統的大流行時代製造照付不議的做法,並且我們正在更多地轉向傳統的簡化營運實體的資產負債表。
And so hopefully, that helps with with the balance sheet.
希望這有助於改善資產負債表。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
It's super helpful.
這非常有幫助。
And then just on monetization of noncore assets, any update on the Czech manufacturing plant would be helpful.
然後,就非核心資產的貨幣化而言,捷克製造工廠的任何更新都會有所幫助。
And then just one more follow-up in that regard.
然後在這方面還有一個後續行動。
John Jacobs - President and CEO
John Jacobs - President and CEO
Jim, you want to take the Czech plant question?
吉姆,你想回答捷克工廠的問題嗎?
Jim Kelly - EVP, CFO, and Treasurer
Jim Kelly - EVP, CFO, and Treasurer
Yes, we'll certainly and I'm Mike, as we continue to drive towards a more lean and agile organization.
是的,我們肯定會這樣做,我是麥克,因為我們將繼續朝著更精簡和敏捷的組織邁進。
Supply chain is of exceptional importance to us without without question and Wally on certainly a difficult decision right to explore this sale.
毫無疑問,供應鏈對我們來說非常重要,而沃利對探索這次出售無疑是一個艱難的決定。
We recognize that it is an area of opportunity for streamlining and improving efficiencies in our supply chain.
我們認識到這是一個精簡和提高供應鏈效率的機會領域。
We do anticipate leveraging this Czech plant here.
我們確實期望在這裡利用這家捷克工廠。
It is a part of our network for delivery of doses into Europe and other, I'll call it Europe, Reliant markets that rely on their regulatory authorization.
它是我們向歐洲和其他依賴監管授權的依賴市場(我稱之為歐洲)輸送劑量的網路的一部分。
And so we're exceptionally thankful to that team and everything they're doing to drive product sales this fall on.
因此,我們非常感謝團隊以及他們為推動今年秋季產品銷售所做的一切。
We are at the beginnings of via working with our broker to get indications of interest.
我們正開始與我們的經紀人合作以獲得興趣跡象。
It's a great plant, and I have every expectation that we will we will certainly have a robust interest, and we'll keep you posted on them.
這是一個很棒的工廠,我堅信我們一定會對此產生濃厚的興趣,並且我們會隨時向您通報有關情況。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
A great.
一個了不起的。
And just a last question about the combo program on integrating what you've have learned from the COVID and flu monotherapy Phase three trials, just what should we look for in the ACIB. public meeting for respiratory vaccines that I'll help sort of build on the recent FDA interactions that you've had.
最後一個問題是關於整合從新冠肺炎和流感單一療法第三階段試驗中學到的知識的組合計劃,我們應該在 ACIB 中尋找什麼。呼吸道疫苗公開會議,我將協助您以最近與 FDA 的互動為基礎。
If you could lay that out, that would be helpful.
如果你能把它列出來,那將會很有幫助。
Thanks again for taking my questions.
再次感謝您回答我的問題。
Filip Dubovsky - President, Research & Development
Filip Dubovsky - President, Research & Development
Yes, I think that's become tricky question.
是的,我認為這已經成為一個棘手的問題。
I mean, we don't have any combination COVID influenza vaccines that have received ACIP approval to date, and we're also expected to come up before ACIPR. for couple of years at the earliest.
我的意思是,到目前為止,我們還沒有任何已獲得 ACIP 批准的新冠流感組合疫苗,而且我們預計也會在 ACIPR 之前提出。最快也要幾年。
So I think we'll have to wait and see.
所以我認為我們必須拭目以待。
We know there's a lot of interest from the public health authorities, both in the U.S. and globally to reduce number of jobs to get people protected.
我們知道,美國和全球公共衛生當局都非常有興趣減少工作數量以保護人們。
And they see it as a way to increase COVID vaccination because people are in large, getting their flu vaccines so I think go, we will see when it happens.
他們認為這是增加新冠疫苗接種的一種方式,因為人們都在接種流感疫苗,所以我想,我們會看看什麼時候會發生。
But I think that, as you know, us and other people in the world are pursuing this because we think it's the right way to go forward.
但我認為,正如你所知,我們和世界上其他人正在追求這一目標,因為我們認為這是前進的正確道路。
Operator
Operator
Alec Stranahan, Bank of America.
亞歷克·斯特拉納漢,美國銀行。
Alec Stranahan - Analyst
Alec Stranahan - Analyst
Hey, guys, good morning.
嘿,夥計們,早安。
Thanks for taking my questions.
感謝您回答我的問題。
Just two quick ones from me and maybe just to put a finer point on the BLA I guess based on the latest FDA guidance?
我只是簡單說兩句,也許只是為了根據最新的 FDA 指南對 BLA 進行更詳細的說明?
And is there a go for or the assumption that a formal BLA will be required to commercialize your COVID vaccine next fall in the US and maybe if you could walk us through what's going on now in remaining hurdles to get both the single dose presentation and and the BLA over the finish line that be correct.
是否有可能或假設明年秋天在美國將您的新冠疫苗商業化需要正式的 BLA,也許您可以引導我們了解目前在剩餘障礙中所發生的事情,以獲得單劑演示和和越過終點線的BLA 是正確的。
Thanks.
謝謝。
John Jacobs - President and CEO
John Jacobs - President and CEO
John Trizzino, do you want to take Alex's question?
John Trizzino,你想回答 Alex 的問題嗎?
John Trizzino - President, COO
John Trizzino - President, COO
Yes.
是的。
Yes.
是的。
So on the BLA pathway is, I mean, is what we're pursuing at the moment.
我的意思是,BLA 途徑是我們目前正在追求的目標。
But as you stated there is unavailability for EUA if that's needed, given timing.
但正如您所說,如果需要的話,考慮到時間,EUA 是不可用的。
The most significant piece of the strategy here is to be on time for market.
該策略中最重要的部分是準時上市。
So whether that be under EUA or BLA will allow us to be present in front of the vaccination season, allow us to bring our prefilled syringe to the market for the convenience of the health care providers.
因此,無論是 EUA 還是 BLA 都將允許我們在疫苗接種季節之前出現,允許我們將預充式註射器推向市場,以方便醫療保健提供者。
And so I think those elements are the most significant piece.
所以我認為這些元素是最重要的部分。
We do have a lot of work that's being conducted between our regulatory teams and our CMC teams with with Sabre to ensure that there's a sharing of information under this rolling submission.
我們的監管團隊和 CMC 團隊與 Sabre 之間確實開展了大量工作,以確保在滾動提交的情況下共享資訊。
The intent of the rolling submission is to get them as much information as early as possible to streamline their review process.
滾動提交的目的是讓他們儘早獲得盡可能多的信息,以簡化他們的審核流程。
And I can't comment upon kind of regulatory timing, but we're making significant headway in making that possible for for the for the fall season.
我無法評論監管時機,但我們正在取得重大進展,使秋季成為可能。
So on look, we're confident in the data that we're providing.
所以看起來,我們對我們提供的數據充滿信心。
We're confident in that process, and we're confident in the data that we have so far to deliver against those three objectives.
我們對這個過程充滿信心,並對迄今為止為實現這三個目標所提供的數據充滿信心。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, John.
謝謝你,約翰。
Operator
Operator
Thank you.
謝謝。
There are no further questions at this time.
目前沒有其他問題。
I will now to turn the call over to Mr. John Jacobs.
我現在將把電話轉給約翰·雅各布斯先生。
You please proceed.
請您繼續。
John Jacobs - President and CEO
John Jacobs - President and CEO
Thank you, everyone, for joining us today.
謝謝大家今天加入我們。
We wish you a great close to your week.
我們祝福您這一週過得愉快。
Operator
Operator
Thank you.
謝謝。
That does conclude your conference for today.
今天的會議到此結束。
Thank you all for participating.
感謝大家的參與。
You may all disconnect.
你們都可以斷開連線。