Novavax Inc (NVAX) 2023 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Second Quarter 2023 Financial Results and Operational Highlights Conference Call.

女士們、先生們，感謝大家的耐心等待，並歡迎參加 Novavax 2023 年第二季度財務業績和運營亮點電話會議。

(Operator Instructions)

（操作員說明）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Erika Schultz, you may begin.

請注意，今天的會議正在錄製中。我現在想把會議交給今天的發言人埃里卡·舒爾茨（Erika Schultz），您可以開始了。

Good morning, and thank you all for joining us today to discuss our second quarter 2023 operational highlights and financial results. 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. Please turn to Slide 2.

早上好，感謝大家今天加入我們討論我們 2023 年第二季度的運營亮點和財務業績。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頻檔案。請翻到幻燈片 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, full year 2023 financial guidance, 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 of its vaccine candidates, the global market opportunities for our vaccine candidates, our manufacturing capacity and the future availability of our vaccine candidates and key upcoming milestones.

在我們開始準備好的發言之前，我需要提醒您，本演示文稿包含前瞻性陳述，包括與Novavax 的未來、其關鍵戰略重點、運營計劃、目標和前景、2023 年全年財務指導、其未來有關的信息財務或業務績效、條件或戰略、其合作夥伴預期未來監管備案和行動的時間和結果；以及候選疫苗的持續開發、候選疫苗的全球市場機會、我們的生產能力和候選疫苗的未來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 can cause actual results to differ materially from those projected in such statements. Additional information regarding these factors appears under the heading Cautionary Notes 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 and available at www.sec.gov and on our website at novavax.com as well as subsequent filings with the SEC.

本演示文稿中包含的每項前瞻性陳述都存在風險和不確定性，可能導致實際結果與此類陳述中的預測存在重大差異。有關這些因素的更多信息出現在我們今天上午發布的幻燈片中有關前瞻性陳述的注意事項標題下以及我們向證券交易委員會提交的最新10-K 表格和隨後的10-Q 表格中的“風險因素”標題下。委員會可在 www.sec.gov 和我們的網站 novavax.com 以及隨後向 SEC 提交的文件中獲取。

The forward-looking statements in this presentation speak as of the original date of this presentation, and we undertake no obligation to update or revise any of these statements. Please turn to Slide 3. This presentation also includes references to a non-GAAP financial measure, which is forward-looking information for R&D and SG&A expenses, as adjusted, to exclude onetime restructuring costs as described on this slide.

本演示文稿中的前瞻性陳述截至本演示文稿的原始日期，我們不承擔更新或修改任何這些陳述的義務。請參閱幻燈片 3。本演示文稿還引用了非 GAAP 財務指標，該指標是經過調整的研發和銷售及管理費用的前瞻性信息，以排除本幻燈片中所述的一次性重組成本。

Please turn to Slide 4. Joining me today is John Jacobs, our President and CEO, who will provide an update on our progress during the quarter for the 3 key priorities. Additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on our commercial activities and Dr. Filip Dubovsky, President of Research and Development, will discuss our COVID clinical development and pipeline.

請參閱幻燈片 4。今天與我一起的是我們的總裁兼首席執行官約翰·雅各布斯 (John Jacobs)，他將介紹我們在本季度 3 個關鍵優先事項方面取得的最新進展。此外，首席商務官兼首席商務官 John Trizzino 將提供我們商業活動的最新信息，研發總裁 Filip Dubovsky 博士將討論我們的 COVID 臨床開發和管道。

Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. Rick Crowley, Chief Operations Officer, will be also available for the Q&A section at the end of today's call. I would now like to hand over the call to John Jacobs. Please turn to Slide 5.

最後，首席財務官兼財務主管 Jim Kelly 將概述我們的財務業績。首席運營官 Rick Crowley 也將出席今天電話會議結束時的問答部分。我現在想將電話轉交給約翰·雅各布斯。請翻到幻燈片 5。

Thank you, Erika, and thank you, everyone, for joining us today to discuss our second quarter 2023 financial results and operational highlights. Since our last earnings call, the entire organization has continued to focus on our 3 priorities for the year: first, delivering an updated product for the upcoming fall season.

謝謝 Erika，也謝謝大家今天加入我們討論我們 2023 年第二季度的財務業績和運營亮點。自上次財報電話會議以來，整個組織繼續關註今年的 3 個優先事項：首先，為即將到來的秋季提供更新的產品。

Second, reducing our rate of spend, managing our cash flow and evolving our scale and structure. And third, driving additional value from our technology platform and portfolio via the advancement of our pipeline and business development activities.

其次，降低支出率，管理現金流並發展我們的規模和結構。第三，通過改進我們的產品線和業務開發活動，從我們的技術平台和產品組合中推動附加價值。

I'm pleased to share with you today the significant progress we've made on all 3 of these priorities for Novavax. Let's start with our first priority, delivering an updated product for the upcoming 2023 fall vaccination season. Thanks to our comprehensive strain change strategy and commercial readiness efforts, we are well positioned to achieve this objective and reiterate our plan to deliver our updated vaccine on time for the fall season. Importantly, we believe we have a competitive product profile and have produced an ample supply to meet anticipated demand this season.

今天，我很高興與您分享我們在 Novavax 的所有 3 個優先事項上取得的重大進展。讓我們從首要任務開始，為即將到來的 2023 年秋季疫苗接種季節提供更新的產品。得益於我們全面的毒株變化策略和商業準備工作，我們完全有能力實現這一目標，並重申我們在秋季按時提供更新疫苗的計劃。重要的是，我們相信我們擁有具有競爭力的產品概況，並生產了充足的供應來滿足本季的預期需求。

We have initiated our filing for authorization in the U.S. and are preparing to file our submissions in the coming weeks in other key markets. For the U.S., our commercial team is fully deployed and focused on ensuring our vaccine is widely available and accessible. Outside of the U.S. our sales continue to be driven by existing APAs with committed orders intended for delivery in the fourth quarter of this year.

我們已開始在美國提交授權申請，並準備在未來幾週內在其他主要市場提交申請。對於美國，我們的商業團隊已全面部署，並專注於確保我們的疫苗廣泛可用和可及。在美國以外，我們的銷售繼續受到現有預約定價安排的推動，承諾訂單預計將於今年第四季度交付。

We are confident in our readiness to deliver an updated, differentiated and competitive vaccine for this fall season. In most of our key target markets, including the U.S., our vaccine, if authorized, would be the only non-mRNA protein-based option available, and we're excited about the potential to offer our vaccine as an important alternative to consumers around the world.

我們有信心為今年秋季提供更新的、差異化的、有競爭力的疫苗。在我們包括美國在內的大多數關鍵目標市場，我們的疫苗如果獲得授權，將是唯一可用的非 mRNA 蛋白選擇，我們對將我們的疫苗作為全球消費者的重要替代品的潛力感到興奮。世界。

John Trizzino will share more about our commercial readiness later in the call. So let's move on to Priority #2, which is to reduce our rate of spend, manage our cash flow and evolve our scale and structure. We continue to make significant progress towards strengthening our financial position during the second quarter with the intent of building a solid financial foundation for long-term value creation.

約翰·特里齊諾 (John Trizzino) 稍後將在電話會議中分享更多有關我們商業準備情況的信息。因此，讓我們繼續討論第二個優先事項，即降低支出率、管理現金流並發展我們的規模和結構。我們在第二季度繼續在加強財務狀況方面取得重大進展，旨在為長期價值創造奠定堅實的財務基礎。

Commercial execution is an important contributor to our financial health. And for the second quarter, we recorded total revenue of $424 million, which brings us to over $500 million in revenue for the first half of the year.

商業執行是我們財務健康的重要貢獻者。第二季度，我們的總收入為 4.24 億美元，這使我們上半年的收入超過 5 億美元。

During the quarter, we also successfully executed and amended APA with Canada, a long-term valued customer. This agreement established a foundation for ongoing supply of our COVID vaccine and negotiated up to $350 million in cash payments to Novavax for 2023, further strengthening our cash position as we head into the fall season.

本季度，我們還成功與長期尊貴客戶加拿大簽署並修訂了APA。該協議為我們持續供應新冠疫苗奠定了基礎，並協商在 2023 年向 Novavax 支付高達 3.5 億美元的現金，在進入秋季時進一步加強我們的現金狀況。

The enhanced partnership with SK Bioscience that we announced earlier today includes an $85 million equity investment in Novavax at a 59% premium to the stock's 90-day volume-weighted average price. This mutually beneficial arrangement evolves our relationship with SK from a contract manufacturing organization to a strategic business partnership Extending SK Biosciences commercialization rights in certain markets, providing Novavax with a milestone payment and future royalties for product sales in key APAC markets, and it significantly improves our financial position by eliminating a $195 million outstanding liability from our balance sheet in 2023.

我們今天早些時候宣布與 SK Bioscience 加強合作，其中包括對 Novavax 進行 8500 萬美元的股權投資，投資價格較該股 90 天成交量加權平均價溢價 59%。這種互惠互利的安排將我們與SK 的關係從合同製造組織發展為戰略業務合作夥伴關係，擴大了SK Biosciences 在某些市場的商業化權利，為Novavax 提供了里程碑式的付款和未來在亞太地區主要市場的產品銷售特許權使用費，並顯著改善了我們的業務2023 年從我們的資產負債表中消除 1.95 億美元的未償負債，從而改善財務狀況。

We are also on track with the global restructuring and cost reduction plans announced last quarter. And as of today, have reduced current liabilities in 2023 by over $1 billion, ending the second quarter with over $900 million in cash and receivables.

我們也正在按計劃實施上季度宣布的全球重組和成本削減計劃。截至今天，2023 年的流動負債減少了超過 10 億美元，第二季度末現金和應收賬款超過 9 億美元。

You will hear more today about our cost management, liability management, cash flow and full year 2023 outlook from Jim Kelly later in the call. Finally, let's discuss Priority #3, which is to leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond Nuvaxovid alone.

今天，您將在稍後的電話會議中聽到 Jim Kelly 詳細介紹我們的成本管理、負債管理、現金流和 2023 年全年展望。最後，讓我們討論一下優先事項#3，即利用我們的技術平台、我們的能力和我們的資產組合來推動 Nuvaxovid 之外的額外價值。

Starting with our pipeline. As COVID evolves into a seasonal public health challenge, along with other respiratory viruses, we are keenly aware of the emerging need for combination vaccines.

從我們的管道開始。隨著新冠肺炎與其他呼吸道病毒一起演變成季節性公共衛生挑戰，我們敏銳地意識到對聯合疫苗的新興需求。

Therefore, as a first step, Novavax has made it a strategic priority to develop our combination vaccine for COVID and influenza. Based on what we see as a robust emerging need and market opportunity, our improving balance sheet and recent progress on our corporate priorities, we've decided to make strategic stage gate investments in 2023 and '24 to independently prepare this new product candidate for late-stage development, and importantly, can do so in line with our stated financial targets.

因此，作為第一步，Novavax 將開發新冠肺炎和流感聯合疫苗作為戰略重點。基於我們所看到的強勁的新興需求和市場機會、不斷改善的資產負債表以及公司優先事項的最新進展，我們決定在2023 年和24 年進行戰略階段門投資，以獨立為這一新產品候選者後期做好準備-階段開發，重要的是，可以根據我們既定的財務目標來實現。

In parallel, we will continue to evaluate the potential to partner this program, and look forward to sharing updates with you as the program progresses. Moving on to Matrix-M collaborations. Our Matrix-M adjuvant is one of the keys to our unique technology platform and continues to offer potential value for both Novavax and our business partners.

與此同時，我們將繼續評估與該計劃合作的潛力，並期待隨著計劃的進展與您分享最新信息。繼續 Matrix-M 合作。我們的 Matrix-M 佐劑是我們獨特技術平台的關鍵之一，並繼續為 Novavax 和我們的業務合作夥伴提供潛在價值。

The R21/Matrix-M adjuvanted malaria vaccine developed by Oxford University and manufactured by Serum Institute of India has received authorizations in multiple countries this year and has the potential to be an important tool in the fight against malaria around the globe.

由牛津大學研發、印度血清研究所生產的R21/Matrix-M佐劑瘧疾疫苗今年已在多個國家獲得授權，有潛力成為全球抗擊瘧疾的重要工具。

As part of this arrangement, Novavax expects to supply and receive payment for Matrix-M in support of launch readiness and will be eligible to receive royalties on future product sales. We also recently announced a new collaboration with the Bill and Melinda Gates Medical Research Institute for use of our Matrix-M adjuvant in preclinical vaccine research.

作為該安排的一部分，Novavax 預計將提供 Matrix-M 並接受付款，以支持發布準備工作，並將有資格獲得未來產品銷售的特許權使用費。我們最近還宣布與比爾和梅琳達·蓋茨醫學研究所開展新的合作，在臨床前疫苗研究中使用我們的 Matrix-M 佐劑。

We have also expanded our discussions to explore the use of our Matrix-M adjuvant in clinical development programs, and we look forward to our continued partnership and important work towards our shared goal of improving global public health.

我們還擴大了討論範圍，探索 Matrix-M 佐劑在臨床開發項目中的使用，我們期待繼續合作，並為實現改善全球公共衛生的共同目標而開展重要工作。

As I have said since I joined Novavax as CEO in late January of this year, we intend to share our successes and opportunities as well as our challenges and risks with you in a transparent manner. So let me be clear. While we are all excited about the progress we've achieved year-to-date on our key priorities, I want to be clear that there is still significant execution risk for our business ahead of us. as we seek regulatory authorizations for our first updated version of Nuvaxovid and prepared to compete in the U.S. market as it converts to a commercial model for the first time.

正如我自今年 1 月下旬加入 Novavax 擔任首席執行官以來所說，我們打算以透明的方式與您分享我們的成功和機遇以及挑戰和風險。讓我說清楚。雖然我們都對今年迄今為止在關鍵優先事項上取得的進展感到興奮，但我想明確的是，我們的業務仍然面臨著巨大的執行風險。我們正在為 Nuvaxovid 的第一個更新版本尋求監管授權，並準備在其首次轉換為商業模式時在美國市場競爭。

Our success as a company will depend in a large part on our continued ability to deliver on these priorities and on the emerging opportunity for COVID vaccination around the globe as the pandemic enters an endemic phase. As we continue to prepare for what should be an exciting opportunity this fall season, I am personally encouraged by the commitment and energy of our management team and all of our employees and sincerely grateful for the support of our loyal investors.

作為一家公司，我們的成功將在很大程度上取決於我們持續履行這些優先事項的能力，以及隨著疫情進入流行階段，全球範圍內新冠疫苗接種的新機會。當我們繼續為今年秋季這個令人興奮的機會做準備時，我個人對我們的管理團隊和所有員工的承諾和精力感到鼓舞，並衷心感謝我們忠實投資者的支持。

You have our continued commitment to give you our best effort and our focus on the key priorities we have outlined. Now I would like to hand it over to additional members of the team to discuss our results from the quarter and in more detail, beginning with John Trizzino to discuss our commercial updates. John?

我們將繼續承諾為您提供最大的努力，並將重點放在我們概述的關鍵優先事項上。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，首先由 John Trizzino 討論我們的商業更新。約翰？

Thanks, John. Please turn to Slide 6. Novavax's COVID vaccine is authorized for use in over 40 countries around the globe. Leading into the '23, '24 fall vaccination season, many of these countries are still purchasing COVID vaccines under advanced purchase agreements, APAs, while in the U.S. moves to traditional vaccine purchasing and commercial operations.

謝謝，約翰。請參閱幻燈片 6。Novavax 的 COVID 疫苗已獲授權在全球 40 多個國家/地區使用。進入“23”、“24”秋季疫苗接種季節，其中許多國家仍在根據提前採購協議（APA）購買新冠疫苗，而美國則轉向傳統的疫苗採購和商業運營。

Today, I will be discussing specific activities and readiness for each region. Please turn to Slide 7. The U.S., as planned, is exiting the pandemic phase and entering a more traditional seasonal vaccine market with many similarities to seasonal annual influenza vaccine distribution.

今天，我將討論每個地區的具體活動和準備情況。請參閱幻燈片 7。美國正在按計劃退出大流行階段，進入更傳統的季節性疫苗市場，與季節性年度流感疫苗分配有許多相似之處。

We have been preparing for commercialization in the U.S. throughout the pandemic phase, and we are ready organization-wide for availability of product as soon as September, of course, dependent on our FDA, strain-specific authorization and ACIP recommendations for use.

在整個大流行階段，我們一直在為在美國的商業化做準備，並且我們已做好準備，最快將於9 月份在整個組織範圍內提供產品，當然，這取決於我們的FDA、特定菌株的授權和ACIP 的使用建議。

As you would expect, there has been significant collaboration across many U.S. agencies and within HHS to ensure that this transition is executed smoothly and there is vaccine available for anyone interested in receiving a COVID vaccine.

正如您所期望的那樣，美國許多機構和 HHS 內部進行了重大合作，以確保這一過渡順利執行，並且為任何有興趣接種新冠疫苗的人提供疫苗。

Critical updates and prioritization of public health objectives over the past few months have provided greater clarity for the upcoming vaccination season and focused our preparation. Let me highlight some of the most important and significant items. Based on the evaluation and recommendation from VRBPAC, the FDA selected the XBB1.5 as the monovalent strain for the '23, '24-COVID season.

過去幾個月公共衛生目標的重要更新和優先順序為即將到來的疫苗接種季節提供了更加明確的信息，並集中了我們的準備工作。讓我強調一些最重要和最重要的項目。根據 VRBPAC 的評估和建議，FDA 選擇 XBB1.5 作為 '23、'24-COVID 季節的單價菌株。

Novavax has been manufacturing this new variance train at commercial scale based on the final strain recommendations in June. Our updated XBB1.5 COVID vaccine is on track to be in our U.S. facility in September and immediately available for distribution and use upon authorization.

Novavax 一直在根據 6 月份的最終菌株建議以商業規模製造這種新的變異序列。我們更新的 XBB1.5 COVID 疫苗預計將於 9 月份進入我們的美國工廠，並在獲得授權後立即可供分發和使用。

Two, HHS Secretary Becerra, outlined 4 priorities for the transition to traditional commercial access of COVID vaccines. Novavax is working to support these priorities by producing sufficient supply of vaccine, ensuring low income and underserved populations have ready access to the vaccine whereby we will be participating in the Bridge Access Program with leading retailers to provide free vaccine to those without insurance coverage, providing a competitively priced vaccine that removes pricing as a barrier to access and working with the U.S. government to share distribution and vaccination data for our XBB-COVID vaccine.

第二，美國衛生與公眾服務部部長貝塞拉概述了新冠疫苗向傳統商業獲取過渡的 4 個優先事項。 Novavax 正在努力通過生產充足的疫苗供應來支持這些優先事項，確保低收入和服務不足的人群能夠隨時獲得疫苗，我們將與領先的零售商一起參與 Bridge Access 計劃，為沒有保險的人提供免費疫苗，一種價格具有競爭力的疫苗，消除了價格作為獲取的障礙，並與美國政府合作分享我們的XBB-COVID 疫苗的分發和疫苗接種數據。

Three, the CDC plays a critical role on multiple fronts for the success of this first season. And I am pleased to report that Novavax has contracts and negotiated pricing in place with the CDC and other entities, including that for the vaccine for children's program funding that has made vaccine available for low-income children since 1994.

第三，疾病預防控制中心在多個方面為第一季的成功發揮了關鍵作用。我很高興地報告，Novavax 與 CDC 和其他實體簽訂了合同並協商定價，其中包括兒童疫苗計劃資金，該計劃自 1994 年以來一直為低收入兒童提供疫苗。

Four, Novavax believes based on its own analysis and consensus across multiple sources that the U.S. market demand for COVID vaccine this fall will range from 80 million to 100 million doses. Of course, market demand and the number of doses needed across all channels and populations in the U.S. can only be estimated, and we will only know for sure as the respiratory disease season unfolds.

第四，Novavax 認為，根據其自身的分析和多個來源的共識，今年秋季美國市場對新冠疫苗的需求將在 8000 萬至 1 億劑之間。當然，市場需求以及美國所有渠道和人群所需的劑量數量只能進行估計，而且只有隨著呼吸道疾病季節的到來，我們才能確定。

What we do know with more certainty is that COVID vaccine strains continue to circulate and there is great value in a safe and effective vaccine to help prevent and to reduce the most severe complications of COVID disease and that Novavax is on track to be ready this fall with the ample COVID vaccine supply in support of U.S. public health needs.

我們更確定地知道，新冠病毒疫苗株仍在繼續傳播，安全有效的疫苗對於幫助預防和減少新冠病毒最嚴重的並發症具有巨大價值，Novavax 有望在今年秋天做好準備充足的新冠疫苗供應可滿足美國公共衛生需求。

With these imperatives in mind, we have put forth tremendous effort to ensure that we are organization-wide ready for the '23, '24 COVID season. Please turn to Slide 8 and allow me to detail specific activity. A core focus for us is manufacturing readiness. We have been manufacturing our updated XBB-COVID vaccine at commercial scale, which will enable us to supply tens of millions of doses of our vaccine in line with our planned demand for the fall season.

考慮到這些當務之急，我們付出了巨大的努力，以確保我們在整個組織範圍內為“23”、“24”新冠疫情季節做好準備。請翻到幻燈片 8，讓我詳細介紹具體活動。我們的核心關注點是製造準備。我們一直在以商業規模生產更新的 XBB-COVID 疫苗，這將使我們能夠根據秋季的計劃需求供應數千萬劑疫苗。

We expect to have doses in our U.S. warehouse in advance of FDA's authorization and ACIP's policy recommendations to ensure that we can quickly ship initial stocking orders to customers in September. We are also keenly focused on our commercial readiness, central to our fall initiatives has been the execution of our targeted commercial contracting strategy.

我們希望在獲得 FDA 授權和 ACIP 政策建議之前將劑量存放在我們的美國倉庫中，以確保我們能夠在 9 月份快速向客戶發貨最初的庫存訂單。我們還非常關注我們的商業準備情況，我們秋季計劃的核心是執行我們有針對性的商業承包戰略。

We continue to believe that the COVID vaccine market dynamics and the channels of distribution will be comparable to the annual seasonal influenza vaccine market. This market intelligence drives our strategy to make our vaccine available to the commercial, government and public health affiliated network of vaccine program stakeholders that are responsible for administering the majority of vaccinations.

我們仍然相信，新冠疫苗市場動態和分銷渠道將與每年的季節性流感疫苗市場相當。這種市場情報推動了我們的戰略，使我們的疫苗能夠提供給負責管理大部分疫苗接種的疫苗計劃利益相關者的商業、政府和公共衛生附屬網絡。

This target group consistently offers and administers greater than 150 million flu vaccinations across the country every fall and winter respiratory virus season. Execution of this strategy means we will make our COVID vaccine available via 3 key health care provider channels and buying groups.

每個秋冬呼吸道病毒季節，該目標群體都會在全國范圍內持續提供和管理超過 1.5 億劑流感疫苗。執行這一戰略意味著我們將通過 3 個主要醫療保健提供者渠道和購買團體提供我們的新冠疫苗。

This would include, but may not be limited to the following: retail pharmacy across all national, regional and independent pharmacies, integrated delivery networks and physician buying groups and public health access via the CDC, VFC, Department of Defense, and Indian Health Services.

這包括但可能不限於以下內容：所有國家、地區和獨立藥店的零售藥房、綜合配送網絡和醫生購買團體以及通過 CDC、VFC、國防部和印度衛生服務部門獲得的公共衛生服務。

This strategy is also dependent on and requires the utilization of a network of well-known and highly experienced vaccine distribution partners to deliver our product to the various points of service across the country.

這一戰略還依賴於並需要利用知名且經驗豐富的疫苗分銷合作夥伴網絡，將我們的產品運送到全國各地的各個服務點。

To that end, once authorized any vaccinating health care provider or vaccinating organization interested in acquiring our vaccine will have a familiar selection of participating distributors that should provide for easy access to our vaccine.

為此，一旦獲得授權，任何有興趣獲得我們疫苗的疫苗接種醫療保健提供者或疫苗接種組織都將擁有熟悉的參與分銷商選擇，這些分銷商應該可以輕鬆獲得我們的疫苗。

Having spent time in my career in the vaccine distribution space, I truly understand and value what our distribution partners bring to Novavax, our customers, and to the consumers who will receive our vaccine.

我在疫苗分銷領域度過了職業生涯，我真正理解並重視我們的分銷合作夥伴為 Novavax、我們的客戶以及將接受我們疫苗的消費者帶來的東西。

To date, we have established critical relationships with key provider and retail buying groups, and executed distribution contracts that ensure national widespread availability to HCPs and ensure consumer choice in their COVID vaccine selection.

迄今為止，我們已與主要提供商和零售購買團體建立了重要關係，並簽署了分銷合同，以確保全國范圍內向 HCP 廣泛提供疫苗，並確保消費者在選擇新冠疫苗時有選擇權。

Our recent progress includes the following: Distributors contracts signed or in process that covers 100% of 3 priority health care provider channels. Pharmacy contracts signed or in progress, representing approximately 80% of vaccines administered in pharmacies. CDC and other government services such as VA, DoD and Indian Health Service contracts are signed and coordination is in process for dose availability per the respective agreements.

我們最近取得的進展包括： 已簽署或正在處理的分銷商合同涵蓋 100% 的 3 個優先醫療保健提供商渠道。已簽署或正在進行的藥房合同，約佔藥房管理疫苗的 80%。疾病預防控制中心和其他政府服務機構（例如退伍軍人管理局、國防部和印度衛生服務局）已簽署合同，並正在根據各自協議就劑量可用性進行協調。

GPO and PPG contracts, physician buying group contracts signed or in final stages will provide access to office-based providers associated with the top integrated delivery networks and major medical groups that drive 90% of the vaccinations within these organizations.

GPO 和 PPG 合同、已簽署或處於最後階段的醫生採購團體合同將提供與頂級綜合交付網絡和主要醫療集團相關的辦公室提供者的訪問權限，這些機構推動了這些組織內 90% 的疫苗接種。

These relationships will ensure we have availability and broad access to key providers and pharmacies to support patient choice of their COVID vaccine. We feel confident that our overall strategy will create convenient nationwide access to our vaccine for any consumer seeking it as well as any health care provider who would like to acquire our vaccine for their COVID vaccination program this fall.

這些關係將確保我們能夠廣泛接觸主要提供者和藥房，以支持患者選擇新冠疫苗。我們相信，我們的總體戰略將為任何尋求疫苗的消費者以及任何希望在今年秋天為他們的新冠疫苗接種計劃購買我們的疫苗的醫療保健提供者在全國范圍內提供方便的獲取我們疫苗的機會。

And finally, we have implemented a commercial pricing strategy that will reflect the overall value that our vaccine delivers, allowing us to achieve broad access to competitively position our vaccine. We continue to see a significant market opportunity in the U.S. based upon our commercial readiness efforts.

最後，我們實施了商業定價策略，該策略將反映我們疫苗所提供的整體價值，使我們能夠獲得廣泛的機會，從而使我們的疫苗具有競爭優勢。基於我們的商業準備工作，我們繼續看到美國存在重大市場機會。

We remain confident in our ability to capture meaningful market share during the upcoming fall season and beyond. Please turn to Slide 9. Ex U.S., we expect total revenue of approximately $700 million from APA orders for 2023 based on committed dose delivery schedules, subject to updated variant manufacturing and regulatory approvals, and I'd like to share some details about how this breaks down.

我們對在即將到來的秋季及以後佔領有意義的市場份額的能力仍然充滿信心。請參閱幻燈片9。在美國以外，我們預計2023 年APA 訂單的總收入約為7 億美元，基於承諾的劑量交付時間表，並取決於更新的變體製造和監管批准，我想分享一些有關如何實現這一目標的詳細信息崩潰了。

In the EU, we will be completing our COVID vaccine shipments against the original APAs before the end of this year when we expect to deliver the remaining 17 million committed doses. The relationships established during the pandemic remains strong across the EU and our commercial organization deployed against key EU markets, including Germany, Spain, France, Italy and Switzerland.

在歐盟，我們將在今年年底前根據最初的 APA 完成新冠疫苗的發貨，預計屆時將交付剩餘的 1700 萬劑承諾疫苗。疫情期間在整個歐盟建立的關係依然牢固，我們的商業組織針對德國、西班牙、法國、意大利和瑞士等主要歐盟市場部署。

We look forward to 2024 and the shift to traditional commercial vaccine distribution, both in the private and tender markets. We expect to continue to grow share in these key markets based upon the expressed need for the non-mRNA option and Nuvaxovid's position as a safe and effective protein-based vaccine approved for use in the EU.

我們期待 2024 年，無論是在私人市場還是招標市場上，都將轉向傳統的商業疫苗分配。基於對非 mRNA 選項的明確需求以及 Nuvaxovid 作為獲准在歐盟使用的安全有效的蛋白質疫苗的地位，我們預計將繼續增加在這些關鍵市場的份額。

In Canada, we amended our APA, which provided for payment of forfeited doses in 2023, reinforced our commitment to establish in-country manufacturing in '24 and '25 and also extended dose purchasing commitments into '24 and '25.

在加拿大，我們修訂了 APA，規定在 2023 年支付被沒收的劑量，加強了我們在 24 年和 25 年建立國內生產的承諾，並將劑量採購承諾延長到 24 年和 25 年。

We are excited to have strengthened our partnership with Canada and establish a foundation for continued vaccine supply. Finally, in Asia Pacific, we have similarly created strong relationships with our country partners in this region. We continue to supply against existing APAs to Australia, New Zealand, Singapore, Taiwan and Israel.

我們很高興加強與加拿大的合作夥伴關係，並為持續供應疫苗奠定基礎。最後，在亞太地區，我們同樣與該地區的國家合作夥伴建立了牢固的關係。我們繼續根據現有預約定價安排向澳大利亞、新西蘭、新加坡、台灣和以色列供貨。

While some APAs continue into '23 and '24, we are beginning to execute against traditional vaccine tender purchasing policy. Interest in vaccine Choice remains high with specific focus on the need for a non-mRNA choice of a protein-based vaccine. Regarding ongoing label expansion and policy recommendations, across all of our priority markets, we are engaged with regulatory authorities and policymaking bodies to expand our label and advance policy recommendations that will enable broad market access.

雖然一些預約定價安排持續到 23 年和 24 年，但我們開始執行傳統的疫苗招標採購政策。人們對疫苗選擇的興趣仍然很高，特別關注對基於蛋白質的疫苗的非 mRNA 選擇的需求。關於正在進行的標籤擴展和政策建議，在我們所有的優先市場中，我們正在與監管機構和政策制定機構合作，以擴展我們的標籤並提出政策建議，從而實現廣泛的市場准入。

We are generating data from our Phase IIb/3 global clinical trial to support expansions to our label in younger children 6 years of age to 11, which Filip will discuss in more detail shortly. And we are making important progress towards ensuring access to our product through supportive policies. As an example, Germany's policy body, the Robert Koch Institute, recently expanded their recommendation for vaccines this fall to include all licensed and variant adaptive vaccines regardless of technology platform. This increasing policy support further drives our confidence that our updated XBB-COVID vaccine will be accessible this fall.

我們正在從 IIb/3 期全球臨床試驗中生成數據，以支持將我們的標籤擴展到 6 歲至 11 歲的幼兒中，Filip 將很快對此進行更詳細的討論。我們在通過支持性政策確保人們獲得我們的產品方面正在取得重要進展。例如，德國政策機構羅伯特·科赫研究所最近擴大了今年秋季疫苗的推薦範圍，將所有獲得許可的疫苗和變體適應性疫苗納入其中，無論技術平台如何。這種不斷增加的政策支持進一步增強了我們的信心，即我們更新的 XBB-COVID 疫苗將於今年秋天上市。

We are also pursuing full approvals in key markets, which will establish the foundation for future regulatory approvals of our updated vaccine. Last month, we received our first full marketing authorization in the EU as a primary series for ages 12 and older and as a booster dose in adults. We are also preparing to file for full approval in other key markets.

我們還在關鍵市場尋求全面批准，這將為我們更新的疫苗未來獲得監管部門批准奠定基礎。上個月，我們在歐盟獲得了第一個全面的營銷授權，作為 12 歲及以上兒童的主要係列和成人的加強劑量。我們還準備在其他主要市場申請全面批准。

In the U.S., we have initiated the rolling submission of our BLA filing and we intend to submit the remainder of our data over the coming months. While full approval via the BLA process will be an important milestone for us early next year we will be able to sell and market our updated XBB COVID vaccine for the upcoming 2023 full vaccination season under emergency use authorization.

在美國，我們已開始滾動提交 BLA 備案，並打算在未來幾個月內提交其餘數據。雖然明年初獲得 BLA 流程的全面批准將是我們的一個重要里程碑，但我們將能夠在緊急使用授權下為即將到來的 2023 年全面疫苗接種季銷售和營銷我們更新的 XBB COVID 疫苗。

Regarding competitive product profiling and positioning, in the majority of countries where we have APAs and in the U.S., our vaccine, if authorized, would be the only non-mRNA-XBB protein-based COVID vaccine option, allowing our vaccine to serve as an important alternative to consumers and health care professionals.

關於競爭性產品分析和定位，在我們擁有 APA 的大多數國家和美國，我們的疫苗如果獲得授權，將是唯一基於非 mRNA-XBB 蛋白的新冠疫苗選擇，使我們的疫苗能夠作為消費者和醫療保健專業人員的重要替代方案。

As we prepare to deliver our updated vaccine for the fall, we remain confident in the competitive product profile of our vaccine. With that said, I'd like to hand it over to Filip to discuss updates for our clinical development and pipeline.

當我們準備在秋季提供更新的疫苗時，我們對疫苗的競爭產品概況仍然充滿信心。話雖如此，我想將其交給 Filip 來討論我們的臨床開發和管道的更新。

Thanks, John. Please turn to Slide 10 and 11. Today, I have to cover 3 topics. First, I'll update you on our strain change study, which is our #1 priority. Then I want to share some new pediatric data before I touch base on plans for our clinical pipeline. Please move to Slide 12.

謝謝，約翰。請翻到幻燈片 10 和 11。今天，我要講 3 個主題。首先，我將向您介紹我們的菌株變化研究的最新情況，這是我們的第一要務。然後，在討論我們的臨床管道計劃之前，我想分享一些新的兒科數據。請移至幻燈片 12。

Study 311 Part 2 is a key study upon which our XBB strain change regulatory filing is based. This study compared a prototype vaccine to BA.5 in a bivalent vaccine with prototype plus BA.5 in 750 adults. The study design was agreed upon with regulatory agencies to support the upcoming strain change filing for XBB 1.5.

研究 311 第 2 部分是一項關鍵研究，我們的 XBB 菌株變更監管備案正是基於該研究。這項研究在 750 名成人中比較了原型疫苗和二價疫苗中的 BA.5，其中原型疫苗加 BA.5。該研究設計已與監管機構達成一致，以支持即將推出的 XBB 1.5 菌株變更備案。

Here are important findings from the study. We achieved all 3 co-primary endpoints. The bivalent vaccine induced a superior neutralizing response against BA.5 compared to the prototype strain vaccine. It also generated a non-inferior BA.5 seroconversion response to noninferior neutralizing response to prototype.

以下是該研究的重要發現。我們實現了所有 3 個共同主要終點。與原型株疫苗相比，二價疫苗誘導了針對 BA.5 的優異中和反應。它還產生了對原型的非劣中和反應的非劣 BA.5 血清轉換反應。

As an aside, the monovalent BA.5 vaccine was more immunogenic than the bivalent, a finding that recapitulated the preclinical data we discussed in the June VRBPAC. And finally, all formulations had similar reactogenicity profiles. Findings from both the BA.1 and BA.5 parts of the 311 study provide reassurance that our manufacturing is consistent and the various strains perform comparably.

順便說一句，單價 BA.5 疫苗比二價疫苗更具免疫原性，這一發現概括了我們在 6 月 VRBPAC 中討論的臨床前數據。最後，所有製劑都具有相似的反應原性特徵。 311 研究的 BA.1 和 BA.5 部分的結果保證了我們的生產是一致的，並且各種菌株的性能相當。

These data have been submitted to the FDA to support regulatory approval for our updated XBB COVID vaccine. In addition to abating our vaccine for the fall season, we continue to work on expanding our label to include the pediatric population. Please go to Slide 13.

這些數據已提交給 FDA，以支持監管機構批准我們更新的 XBB COVID 疫苗。除了在秋季減少疫苗接種外，我們還繼續努力擴大我們的標籤範圍，將兒科人群包括在內。請轉到幻燈片 13。

Study 503 is our global pediatric HD escalation study being conducted in children 6 months of age to 11 years of age. Enrollment is complete in the 6- to 11-year-old cohort and the 2- to 5-year-olds but is ongoing in young children. The data on this slide is preliminary top line data for the 6- to 11-year-old cohort. On the right-hand side, we display validated neutralizing responses after 2 doses. As the group, the children achieved a titer of 5,380, which represents a geometric fold rise of over 21-fold.

研究 503 是我們針對 6 個月至 11 歲兒童進行的全球兒科 HD 升級研究。 6 至 11 歲隊列和 2 至 5 歲兒童的註冊工作已完成，但幼兒的註冊工作仍在繼續。這張幻燈片上的數據是 6 至 11 歲群體的初步頂線數據。在右側，我們顯示了兩次劑量後經過驗證的中和反應。作為該組，孩子們的滴度達到了 5,380，這代表著幾何倍數增長了超過 21 倍。

To put this value in context, this is fivefold higher than seen in our adult Phase III study conducted in U.S., Mexico, which was associated with high levels of protection. The protocol-defined primary effectiveness endpoint was to demonstrate the immune responses in children was not inferior to the immune responses and young adults in the U.S. Mexico Phase III study.

從背景來看，這個值比我們在美國和墨西哥進行的成人 III 期研究高出五倍，該研究與高水平的保護有關。方案定義的主要有效性終點是證明兒童的免疫反應並不遜色於美國墨西哥 III 期研究中的免疫反應和年輕人。

The children's immune responses was not inferior for both the geometric mean titer as well as seroconversion rate. Overall, we saw a reassuring safety profile through 20 days post dose 2. The unsolicited adverse events and medically attended adverse events were balanced between vaccine and placebo and represented common childhood illnesses. There were no related SAEs, no related to severe events, no adverse events of special interest, no myocarditis and no pericarditis.

兒童的免疫反應在幾何平均滴度和血清轉化率方面均不遜色。總體而言，我們在第2 次給藥後20 天看到了令人放心的安全性。疫苗和安慰劑之間未經請求的不良事件和醫療處理的不良事件是平衡的，代表了常見的兒童疾病。沒有相關的SAE，沒有與嚴重事件相關，沒有特別關注的不良事件，沒有心肌炎和心包炎。

We also evaluate clinical efficacy. However, over the short observation window, we only observed 2 cases and they are both in the placebo group. Please move to Slide 14 to look at reaction events. Here we have displayed record genicity events after dose 1 on the top of the slide and dose 2 on the bottom of the slide. Local symptoms are on the left-hand side, in blue, and systemic symptoms are in green on the right.

我們還評估臨床療效。然而，在很短的觀察期內，我們只觀察到了 2 例病例，而且他們都屬於安慰劑組。請移至幻燈片 14 查看反應事件。在這裡，我們在載玻片頂部顯示了劑量 1 後的記錄原性事件，在載玻片底部顯示了劑量 2 後的記錄原性事件。局部症狀在左側，呈藍色，全身症狀在右側呈綠色。

For each term, most children reported no symptoms. And when they did have symptoms, the vast majority were reported as mild or moderate. There was no significant increase of symptoms between dose 1 and dose 2. We think our vaccine may play a special role in the pediatric population. The vaccine appears to be very well tolerated while inducing robust and charging responses. This profile, in addition to our classic common protein technology may be reassuring when parents and providers choose vaccines for children.

每個學期，大多數兒童都沒有報告任何症狀。當他們確實出現症狀時，絕大多數人報告為輕度或中度。第 1 劑和第 2 劑之間的症狀沒有顯著增加。我們認為我們的疫苗可能在兒科人群中發揮特殊作用。該疫苗似乎具有很好的耐受性，同時能引起強烈的反應。當父母和提供者為兒童選擇疫苗時，除了我們經典的常見蛋白質技術之外，這種概況可能會令人放心。

We expect to submit these preliminary results to the EUA in the fourth quarter. And while the length of regulatory review is not known, we believe that approval of EUA amendment could occur in early 2024 Okay. Let's move to the next slide, Slide 15, and review our plans for the clinical pipeline in support of our third corporate pillar.

我們預計將在第四季度向 EUA 提交這些初步結果。雖然監管審查的持續時間尚不清楚，但我們相信 EUA 修正案可能會在 2024 年初獲得批准。讓我們轉到下一張幻燈片（幻燈片 15），回顧一下我們支持第三個企業支柱的臨床管道計劃。

Last quarter, I shared some top line data from our clinical programs, and we are still awaiting final humoral and cellular immune readouts to finalize formulation decisions. But as John mentioned, we made some stage-gated investments to keep development on track.

上個季度，我分享了我們臨床項目的一些重要數據，我們仍在等待最終的體液和細胞免疫讀數以最終確定配方決策。但正如約翰提到的，我們進行了一些階段性投資，以保持發展步入正軌。

For COVID influenza combination vaccine candidate, we showed immune responses from the combination were comparable to license influenza vaccines as well as our authorized color vaccine. This is a priority pipeline asset for us. because there's consumer and medical provider preference for a combination of vaccines.

對於候選新冠肺炎流感組合疫苗，我們表明該組合的免疫反應與許可的流感疫苗以及我們授權的彩色疫苗相當。這是我們的優先管道資產。因為消費者和醫療提供者更喜歡聯合疫苗。

We will be investing in developing a co-formulate vaccine in preparation of the Phase II study planned for next year. The purpose of the Phase IIb study will be to establish a robust safety database for the co-formulated product and confirm the previous immunogenicity. We believe the stage gated investment will provide all the data needed for regulatory interactions prior to our Phase III decision and increase the asset's overall value.

我們將投資開發一種複合疫苗，為明年計劃的二期研究做準備。 IIb期研究的目的是為聯合配方產品建立強大的安全性數據庫並確認之前的免疫原性。我們相信，階段性門控投資將在我們做出第三階段決策之前提供監管互動所需的所有數據，並提高資產的整體價值。

We continue to evaluate ways to accelerate this program and secure sufficient funding for a large and complex pivotal Phase III study, for example, through strategic partnerships. For stand-alone influenza vaccine candidate, we showed you our vaccine-induced wild-type HAI responses that were overall better than 2 market-leading license vaccines.

我們將繼續評估加速該計劃的方法，並為大型複雜的關鍵三期研究確保足夠的資金，例如通過戰略合作夥伴關係。對於獨立的候選流感疫苗，我們向您展示了我們的疫苗誘導的野生型 HAI 反應，總體優於 2 種市場領先的許可疫苗。

While the combination COVID-influenzea vaccine will be our primary focus, the clinical development plan does maintain an option to take the stand-alone flu products through advanced development. We also recognize that our influenza vaccine platform may be attractive from a pandemic preparedness perspective because the currently available avian influenza vaccines are poorly immunogenic.

雖然新冠肺炎聯合流感疫苗將是我們的主要關注點，但臨床開發計劃確實保留了通過高級開發來採用獨立流感產品的選擇。我們還認識到，從大流行防範的角度來看，我們的流感疫苗平台可能具有吸引力，因為目前可用的禽流感疫苗免疫原性較差。

Preclinical evaluation is ongoing for 3 different highly pathogenic A/H5N1 2.3.4.4B strains. Now that optimal target product profile will allow for a single-dose pandemic vaccine, which has been elusive with other vaccine technologies. And finally, for our high-dose COVID vaccine candidate, we shared our immuno responses were improved with higher antigen doses without increasing reactogenicity and we plan on starting a high-dose coped vaccine study in older adults in the fourth quarter. Now these 3 vaccine candidates exemplify the inherent flexibility and potency of our adjuvanted recombinant protein nanoparticle technology.

正在對 3 種不同的高致病性 A/H5N1 2.3.4.4B 毒株進行臨床前評估。現在，最佳目標產品概況將允許單劑量大流行疫苗的出現，而這在其他疫苗技術中是難以實現的。最後，對於我們的高劑量候選新冠疫苗，我們分享了我們的免疫反應在不增加反應原性的情況下通過更高的抗原劑量得到改善，我們計劃在第四季度開始針對老年人的高劑量應對疫苗研究。現在，這 3 種候選疫苗體現了我們的佐劑重組蛋白納米顆粒技術固有的靈活性和效力。

We can induce very broad immune responses and long-lived cellular responses. You've seen that we use -- can use high antigen doses without compromising tolerability. This is critical as we think about high antigen dose applications for difficult to immunize populations such as older adults and allows us to modulate antigen dosage levels in combination of vaccines to overcome hemologic interference.

我們可以誘導非常廣泛的免疫反應和長期的細胞反應。您已經看到我們可以使用高劑量的抗原而不影響耐受性。這一點至關重要，因為我們考慮對老年人等難以免疫的人群進行高抗原劑量應用，並允許我們結合疫苗調節抗原劑量水平以克服血液學乾擾。

These features are important and potentially differentiate our products. The vision is to leverage these attributes and establish a leadership position in the seasonal respiratory viral vaccine space. We think the space will be dominated by combination vaccines and target a number of pathogens that are specifically troublesome for older adults, including influenza, COVID, RSV and HMPV. Okay. Let me hand it off to Jim to discuss our financial results.

這些功能很重要，並且可能使我們的產品脫穎而出。我們的願景是利用這些屬性並在季節性呼吸道病毒疫苗領域建立領導地位。我們認為該領域將由聯合疫苗主導，並針對一些對老年人特別麻煩的病原體，包括流感、新冠病毒、呼吸道合胞病毒和HMPV。好的。讓我把它交給吉姆來討論我們的財務業績。

Thank you, Filip. This morning, we announced our financial results for the second quarter of 2023. Details of our results can be found in our press release issued today and our 10-Q filing. In addition, we also announced this morning the execution of agreements with SK Bioscience that enhance our strategic business partnership and include an $85 million equity investment in Novavax at a 59% premium to the 90-day volume weighted average price.

謝謝你，菲利普。今天早上，我們公佈了 2023 年第二季度的財務業績。有關業績的詳細信息，請參閱我們今天發布的新聞稿和 10-Q 備案文件。此外，我們今天上午還宣布與 SK Bioscience 簽署協議，加強我們的戰略業務合作夥伴關係，其中包括以 90 天交易量加權平均價格溢價 59% 的價格對 Novavax 進行 8500 萬美元的股權投資。

I'll begin by providing an overview of our second quarter 2023 results. Then I'll provide more details regarding our quarterly results, liability management and progress on our global restructuring and cost reduction plan. Finally, I'll share an update on our financial guidance for the full year 2023. Please turn to Slide 17.

首先，我將概述 2023 年第二季度的業績。然後我將提供有關我們的季度業績、負債管理以及全球重組和成本削減計劃進展的更多詳細信息。最後，我將分享 2023 年全年財務指引的最新信息。請參閱幻燈片 17。

For the second quarter of 2023, we recorded $424 million in total revenue, reflecting a $239 million and 128% increase as compared to the second quarter of 2022. Combined R&D and SG&A expenses for the second quarter of 2023 were $313 million.

2023 年第二季度，我們的總收入為 4.24 億美元，較 2022 年第二季度增加 2.39 億美元，增長 128%。2023 年第二季度的研發和銷售、一般行政費用合計為 3.13 億美元。

This reflects an $85 million or 21% decrease compared to the second quarter of 2022 and $46 million or 13% decrease compared to the first quarter of 2023. This improvement represents the continued progress of our ongoing cost reduction plan and demonstrates our commitment towards an improved financial profile to drive long-term value.

這反映出與2022 年第二季度相比減少了8500 萬美元，即21%，與2023 年第一季度相比減少了4600 萬美元，即13%。這一改進代表了我們正在進行的成本削減計劃的持續進展，並表明我們致力於改進財務狀況以驅動長期價值。

Additionally, in the first half of 2023, we reduced our outstanding liabilities by $864 million, including a $323 million reduction in the second quarter of 2023. The with the SK Bioscience announcement today and settlement of related manufacturing agreements, the reduction to current liabilities now exceeds $1 billion for the year.

此外，2023 年上半年，我們的未償負債減少了 8.64 億美元，其中 2023 年第二季度減少了 3.23 億美元。隨著 SK Bioscience 今天的公告以及相關製造協議的結算，流動負債現已減少全年超過10億美元。

And finally, we ended the second quarter with $518 million in cash and an accounts receivable balance of $395 million for a combined total of over $900 million as we head into the fall vaccination season. Please turn to Slide 18.

最後，隨著秋季疫苗接種季節的到來，我們第二季度末的現金為 5.18 億美元，應收賬款餘額為 3.95 億美元，總計超過 9 億美元。請翻到幻燈片 18。

Beginning with revenue. Our second quarter 2023 performance benefited from improvements to both product sales of Nuvaxovid and grant revenue as we recorded total revenue of $424 million compared to $186 million in the second quarter of 2022.

從收入開始。我們 2023 年第二季度的業績得益於 Nuvaxovid 產品銷售和贈款收入的改善，總收入為 4.24 億美元，而 2022 年第二季度為 1.86 億美元。

Of note, this materially reflects the final sales of our Wuhan vaccine for the season. Our cost of sales for the second quarter of 2023 were $56 million compared to $271 million in the second quarter of 2022. This includes $2 million related to excess obsolete or expired inventory and losses on firm purchase commitments as compared to $255 million in the same period in 2022.

值得注意的是，這實質上反映了我們本季度武漢疫苗的最終銷量。我們 2023 年第二季度的銷售成本為 5600 萬美元，而 2022 年第二季度為 2.71 億美元。其中包括與過量過時或過期庫存以及確定採購承諾損失相關的 200 萬美元，而同期為 2.55 億美元2022年。

Research and development expenses for the second quarter of 2023 were $219 million compared to $290 million for the second quarter of 2022. The decrease was primarily due to a reduction in clinical and manufacturing spend.

2023 年第二季度的研發費用為 2.19 億美元，而 2022 年第二季度的研發費用為 2.9 億美元。這一下降主要是由於臨床和製造支出的減少。

Selling, general and administrative expenses for the second quarter of 2023 were $94 million compared to $108 million in the second quarter of 2022. The decrease was primarily due to a reduction in spend by corporate support functions as outlined in the global restructuring and cost reduction plan announced in May.

2023 年第二季度的銷售、一般和管理費用為 9400 萬美元，而 2022 年第二季度為 1.08 億美元。減少的主要原因是全球重組和成本削減計劃中概述的企業支持職能支出減少五月份宣布。

Second quarter of 2023, total operating expenses included $15 million in onetime restructuring costs related to workforce reduction, fixed asset write-offs and the consolidation of certain facilities, of which $12 million was recorded in SG&A.

2023 年第二季度，總運營費用包括 1500 萬美元的一次性重組成本，涉及裁員、固定資產沖銷和某些設施的整合，其中 1200 萬美元記錄在 SG&A 中。

These charges reflect substantially all of the restructuring costs we expect to record under our restructuring plan. For the second quarter of 2023, we recorded net income of $58 million compared to a net loss of $510 million in the second quarter of 2022. Please turn to Slide 19. Today, we announced new agreements with SK Bioscience and reflect the evolution of our relationship from a contract manufacturer arrangement to a strategic business partnership including an equity investment by SK Bioscience in Novavax.

這些費用基本上反映了我們預計根據重組計劃記錄的所有重組成本。 2023 年第二季度，我們的淨利潤為5800 萬美元，而2022 年第二季度的淨虧損為5.1 億美元。請參閱幻燈片19。今天，我們宣布與SK Bioscience 達成新協議，反映了我們的發展歷程關係從合同製造商安排到戰略業務合作夥伴關係，包括 SK Bioscience 對 Novavax 的股權投資。

First, the upgraded agreements extend SK Biosciences commercial rights in South Korea, Thailand and Vietnam, and provides for a $4 million milestone to Novavax and return for the extension of these rights in addition to existing economic terms, which include royalties on future product sales in those markets.

首先，升級後的協議擴展了SK Biosciences 在韓國、泰國和越南的商業權利，並為Novavax 提供了400 萬美元的里程碑，並在現有經濟條款（包括未來產品銷售的特許權使用費）之外，還為擴展這些權利提供了回報。那些市場。

Second, SK Bioscience is making an $85 million equity investment in Novavax' common stock at $13 a share reflecting a 59% premium to the volume weighted average price over the 90 days prior to August 8, 2023.

其次，SK Bioscience 將以每股 13 美元的價格對 Novavax 普通股進行 8500 萬美元的股權投資，較 2023 年 8 月 8 日之前 90 天的成交量加權平均價格溢價 59%。

Third, the agreement settled $195 million in outstanding Novavax contract manufacturing liabilities for $154 million. In total, under these agreements, Novavax will issue 6.5 million common shares and pay net cash of $65 million to SK Bioscience to settle $195 million current liability as of June 30, 2023.

第三，該協議以 1.54 億美元的價格解決了 1.95 億美元的 Novavax 未償合同製造負債。總的來說，根據這些協議，Novavax 將發行 650 萬股普通股，並向 SK Bioscience 支付 6500 萬美元的淨現金，以截至 2023 年 6 月 30 日結清 1.95 億美元的流動負債。

Please turn to Slide 20. We've made significant progress to reduce our outstanding current liabilities, including the reduction of $323 million during the second quarter and $864 million in total for the first half of 2023.

請參閱幻燈片 20。我們在減少未償流動負債方面取得了重大進展，包括第二季度減少了 3.23 億美元，2023 年上半年總共減少了 8.64 億美元。

And as we just discussed, the SK Bioscience agreement announced today reduces our current liabilities by $195 million for a total reduction of over $1 billion year-to-date in 2023. Please turn to Slide 21.

正如我們剛才所討論的，今天宣布的 SK Bioscience 協議將我們的流動負債減少 1.95 億美元，到 2023 年迄今為止總共減少超過 10 億美元。請參閱幻燈片 21。

In May, we announced our global restructuring and cost reduction plan Today, we remain on track to significantly reduce Novavax's expenses while retaining capabilities needed to drive results and build future value. For the full year 2023, we reiterate our target to reduce our annual combined R&D and SG&A expenses to between $1.3 billion and $1.4 billion, reflecting a 20% to 25% reduction as compared to 2022.

五月份，我們宣布了全球重組和成本削減計劃。今天，我們仍將大幅減少 Novavax 的開支，同時保留推動業績和創造未來價值所需的能力。對於 2023 年全年，我們重申我們的目標是將年度研發和銷售、一般行政費用合計減少至 13 億至 14 億美元，與 2022 年相比減少 20% 至 25%。

For the full year 2024, we also reiterate our target of R&D and SG&A expenses of below $1 billion, reflecting a 40% to 50% decrease when compared to 2022. Importantly, we've been able to further reduce our anticipated cost structure to allow us to now include onetime restructuring costs, and strategic stage gate investments to advance our Kick Flu program towards late-stage development in 2023 and 2024, while maintaining our R&D and SG&A expense guidance. In summary, we are on target with our plans to reduce our R&D and SG&A scale and cost structure by 40% to 50% in 2024.

對於 2024 年全年，我們還重申研發和銷售及管理費用低於 10 億美元的目標，與 2022 年相比減少 40% 至 50%。重要的是，我們已經能夠進一步降低預期成本結構，以允許我們現在包括一次性重組成本和戰略階段投資，以推動我們的Kick Flu 計劃在2023 年和2024 年進入後期開發，同時維持我們的研發和SG&A 費用指導。總而言之，我們的目標是到 2024 年將研發和銷售、一般行政費用規模和成本結構減少 40% 至 50%。

We have aggressively reduced our current liabilities by over $1 billion in 2023 and approached the fall vaccination season with over $900 million in cash and receivables, all supporting our intent of building a solid financial foundation for long-term value creation. Please turn to Slide 22.

到2023 年，我們已大幅減少了超過10 億美元的流動負債，並在秋季疫苗接種季節到來之際，擁有超過9 億美元的現金和應收賬款，所有這些都支持我們為長期價值創造奠定堅實的財務基礎的意圖。請翻到幻燈片 22。

Before discussing our full year 2023 financial guidance, I am pleased to share that since April, we've secured up to approximately $600 million in cash to improve our cash runway. The up to $450 million in cash payments negotiated this year under our Canada APA represent an important source of nondilutive funding for the company. In addition, we've raised $153 million of equity capital through an $85 million investment by SK Bioscience and $68 million in equity raised through our ATM program at an average combined price representing a significant premium to our 90-day volume weighted average price. I'd like to spend a moment on the accounting associated with the up to $450 million in nondilutive cash payments in 2023 related to for fitted doses.

在討論 2023 年全年財務指引之前，我很高興地告訴大家，自 4 月份以來，我們已獲得約 6 億美元的現金來改善我們的現金跑道。今年根據加拿大 APA 談判達成的高達 4.5 億美元的現金支付是該公司非稀釋資金的重要來源。此外，我們還通過 SK Bioscience 的 8500 萬美元投資籌集了 1.53 億美元的股本，並通過我們的 ATM 計劃籌集了 6800 萬美元的股本，平均合併價格明顯高於我們 90 天交易量加權平均價格。我想花點時間談談 2023 年與裝配劑量相關的高達 4.5 億美元的非稀釋性現金支付的會計處理。

These amounts will be initially recorded as deferred revenue, along with existing related upfront payments for these forfeited doses. These combined amounts will later be recognized ratably as product sales between 2023 and 2025 as the remaining performance obligations are met under the amended Canada APA.

這些金額最初將記錄為遞延收入，以及這些被沒收劑量的現有相關預付款。由於剩餘履約義務已根據修訂後的加拿大 APA 得到履行，這些合併金額隨後將按比例確認為 2023 年至 2025 年之間的產品銷售額。

We do not expect this to be a material contributor to 2023 product sales. Regarding payment timing, we received the initial $100 million cash payment related to the April 2023 EPA amendment in the second quarter of 2023. The up to $350 million in cash payments associated with the June 2023 APA amendment are to be paid in 2 equal installments of $175 million.

我們預計這不會對 2023 年產品銷售產生實質性貢獻。關於付款時間，我們在2023 年第二季度收到了與2023 年4 月EPA 修正案相關的首筆1 億美元現金付款。與2023 年6 月APA 修正案相關的高達3.5 億美元的現金付款將分兩期等額支付。 1.75 億美元。

The first $175 million payment was received in July 2023, and a second $175 million payment is contingent and payable upon delivery of vaccine in the second half of 2023. Of note, for our full year 2023 revenue guidance $100 million of the up to $350 million cash payments associated with the June APA amendment was included in the prior full year 2023 product sales and total revenue guidance.

第一筆1.75 億美元的付款已於2023 年7 月收到，第二筆1.75 億美元的付款是或有的，應在2023 年下半年交付疫苗時支付。值得注意的是，對於我們2023 年全年的收入指導，高達3.5 億美元中的1 億美元是有條件的。與 6 月 APA 修正案相關的現金支付已包含在 2023 年全年產品銷售和總收入指導中。

For this reason, we are removing this $100 million cash payment from our full year 2023 revenue guidance. With that said, let's turn to our full year 2023 financial guidance. We expect to achieve full year 2023 total revenue of between $1.3 billion and $1.5 billion, including product sales of between $960 million and $1.140 billion and grant revenue of between $340 million and $360 million.

因此，我們將從 2023 年全年收入指導中刪除這 1 億美元的現金支付。話雖如此，讓我們來看看 2023 年全年財務指引。我們預計 2023 年全年總收入將在 13 億美元至 15 億美元之間，其中產品銷售額在 9.6 億美元至 11.4 億美元之間，贈款收入在 3.4 億美元至 3.6 億美元之間。

Our full year 2023 product sales guidance includes U.S. market product sales of between $260 million and $440 million and approximately $700 million in APA product sales based on 2023 committed dose delivery schedules each subject to updated variant manufacturing and regulatory approvals as well as successful pull-through in the U.S. market.

我們的2023 年全年產品銷售指南包括2.6 億至4.4 億美元的美國市場產品銷售額，以及基於2023 年承諾劑量交付計劃的約7 億美元的APA 產品銷售額，每個計劃均需經過更新的變體製造和監管批准以及成功的拉通在美國市場。

In the first half of 2023, we recorded $505 million in total revenue, which is in line with the expected phasing of total revenue guidance provided in May. As a result, we expect total revenue of approximately $800 million to $1 billion in the second half of 2023.

2023 年上半年，我們的總收入為 5.05 億美元，這與 5 月份提供的總收入指導的預期階段一致。因此，我們預計 2023 年下半年的總收入約為 8 億至 10 億美元。

In addition, we expect that our updated XBB COVID vaccine product sales will materially occur in the fourth quarter. This is based on the recent U.S. FDA announcement for plans to approve updated covet vaccines in late September, plus the expected timing for other regulatory approvals and deliveries of our updated XBB-code-vaccine outside the U.S.

此外，我們預計更新後的 XBB COVID 疫苗產品銷售將在第四季度實質性發生。這是基於美國 FDA 最近宣布的計劃在 9 月底批准更新的疫苗，以及其他監管部門批准和在美國境外交付更新的 XBB 代碼疫苗的預期時間。

For expenses, as I mentioned earlier, we are reiterating our targets to reduce our combined R&D and SG&A expenses for the full year 2023 and 2024. Of note, our combined R&D and SG&A expenses for the second quarter of 2023 were $313 million. The midpoint of our full year 2023 R&D and SG&A guidance range implies an approximately $340 million quarterly run rate for the second half of 2023.

對於費用，正如我之前提到的，我們重申了減少 2023 年和 2024 年全年研發和 SG&A 費用的目標。值得注意的是，2023 年第二季度我們的研發和 SG&A 費用合計為 3.13 億美元。我們 2023 年全年研發和 SG&A 指導範圍的中點意味著 2023 年下半年的季度運行費用約為 3.4 億美元。

In the coming quarters, we expect to see a seasonal increase in our sales and marketing investments as our commercial team executes during the fall 2023 vaccination season. If successful in achieving the full year 2023 guidance outlined today, we believe this will support the funding of our operations for the next 12 months.

在接下來的幾個季度中，隨著我們的商業團隊在 2023 年秋季疫苗接種季節期間執行任務，我們預計我們的銷售和營銷投資將出現季節性增長。如果成功實現今天概述的 2023 年全年指導，我們相信這將為我們未來 12 個月的運營提供資金支持。

In our 10-Q filing, you will see that we have provided an update on our going concern disclosure, which we first provided in our 10-K filing in February. Specifically that this forecast continues to be subject to significant uncertainty related to revenue for the next 12 months, funding from the U.S. government and pending arbitration.

在我們的 10-Q 文件中，您會看到我們提供了有關持續經營披露的更新，我們在 2 月份的 10-K 文件中首次提供了這一信息。具體來說，這一預測繼續受到與未來 12 個月收入、美國政府資助和懸而未決的仲裁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. With that, I'd like to turn the call back over to John for some closing remarks.

當我們尋求改善 Novavax 的財務業績、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信息。說到這裡，我想將電話轉回給約翰，讓他做一些結束語。

Thank you, Jim. Please turn to Slide 23. I'd like to close today's call by reiterating the important progress we've made on all 3 priorities for 2023. The updates we shared today reflect meaningful progress against our priorities, which are intended to place Novavax on a path to success both this year and beyond.

謝謝你，吉姆。請參閱幻燈片23。我想通過重申我們在2023 年所有3 個優先事項上取得的重要進展來結束今天的電話會議。我們今天分享的更新反映了我們優先事項方面取得的有意義的進展，這些優先事項旨在使Novavax 處於一個今年及以後的成功之路。

During the past quarter and through midyear, we have under Priority 1, continue to prepare for the fall season and have now manufactured our XBB vaccine at commercial scale with ample supply, initiated our regulatory filing with FDA and have our commercial team fully deployed with the majority of U.S. commercial contracts completed or in progress to ensure broad access to our vaccine this fall.

在過去的季度和年中，我們的首要任務是繼續為秋季做好準備，現在已經以商業規模生產我們的 XBB 疫苗，供應充足，向 FDA 啟動了監管備案，並讓我們的商業團隊全面部署大多數美國商業合同已完成或正在進行中，以確保今年秋天廣泛獲得我們的疫苗。

Priority 2, so we've significantly reduced our current liabilities by over $1 billion and in parallel have built a cash and receivables balance of over $900 million as we head into the fall vaccination season. We are also on track with our cost reduction initiatives. And in addition, we're able to absorb our onetime related restructuring charges within those stated targets.

優先事項 2，因此，隨著秋季疫苗接種季節的到來，我們已將流動負債大幅減少了超過 10 億美元，同時現金和應收賬款餘額已超過 9 億美元。我們的成本削減計劃也正步入正軌。此外，我們能夠在這些既定目標內吸收一次性相關重組費用。

Under Priority 3, we will be advancing our pipeline of future assets with a priority focus on our new combination vaccine program and secondarily, our stand-alone flu program, as Filip outlined earlier in the call.

正如菲利普早些時候在電話會議中概述的那樣，在優先事項 3 下，我們將推進我們的未來資產管道，優先關注我們的新組合疫苗計劃，其次是我們的獨立流感計劃。

Regarding business development, we signed a new agreement with SK Bioscience that includes an $85 million investment in Novavax at a premium and removes the $195 million current liability from our balance sheet. In addition, new approvals were achieved for the R21 malaria vaccine and we anticipate upcoming sales of Matrix-M to support that launch as well as potential royalties from future sales.

在業務發展方面，我們與 SK Bioscience 簽署了一項新協議，其中包括對 Novavax 進行 8500 萬美元的溢價投資，並從我們的資產負債表中刪除 1.95 億美元的流動負債。此外，R21 瘧疾疫苗獲得了新的批准，我們預計 Matrix-M 即將上市，以支持該疫苗的上市以及未來銷售的潛在特許權使用費。

And we were proud to announce that we signed an agreement with the Bill & Melinda Gates Medical Research Institute to advance several vaccine development programs using our Matrix-M technology and look forward to furthering that partnership. When I first joined you all in February for the fourth quarter earnings call, I pledge to you our commitment to be transparent about our opportunities as well as our challenges and to provide a balanced perspective on our progress.

我們很自豪地宣布，我們與比爾及梅琳達·蓋茨醫學研究所簽署了一項協議，利用我們的 Matrix-M 技術推進多個疫苗開發項目，並期待進一步深化這種合作關係。當我在二月份第一次參加第四季度財報電話會議時，我向你們保證，我們承諾對我們的機遇和挑戰保持透明，並對我們的進展提供平衡的視角。

With this commitment in mind, I hope you can see from today's announcement that we have made significant progress on our key priorities so far this year and have overcome several of the barriers to success we have highlighted since my arrival. And importantly, that these successes have helped to put the company in a better position now to achieve our objectives for the year as we approach the fall season.

牢記這一承諾，我希望大家能夠從今天的公告中看到，今年迄今為止我們在關鍵優先事項上取得了重大進展，並且克服了自我上任以來我們強調的一些成功障礙。重要的是，這些成功幫助公司現在處於更好的位置，以在秋季臨近時實現我們今年的目標。

That being said, we cannot yet claim a successful year. as there is still much work to be done with significant execution risk ahead of us. Much of our success this year will be dependent on how and when regulatory authorities react to our filings, how the fall season unfolds, including demand for COVID vaccine in general.

話雖如此，我們還不能說這是成功的一年。因為我們還有很多工作要做，執行風險也很大。我們今年的成功很大程度上取決於監管機構如何以及何時對我們的備案做出反應，秋季如何展開，包括對新冠疫苗的總體需求。

And we will need to continue to execute successfully against all of our objectives. I want you to know that I am confident in our management team and in our organization's desire and focus to advance our objectives. It is with humility that I give you our full commitment to continue these efforts with the goal of delivering our vaccine this season to consumers around the world and doing our best to deliver a successful performance for our company and our shareholders and all key stakeholders in 2023. With that, we will now take your questions.

我們需要繼續成功地實現我們的所有目標。我想讓您知道，我對我們的管理團隊以及我們組織推進目標的願望和重點充滿信心。我懷著謙遜的態度向您承諾，我們將繼續努力，目標是在本季度向世界各地的消費者提供我們的疫苗，並儘最大努力在2023 年為我們的公司、股東和所有主要利益相關者帶來成功的業績. 現在我們將回答您的問題。

(Operator Instructions)

（操作員說明）

First question will come from Roger Song with Jefferies.

第一個問題將由 Jefferies 的 Roger Song 提出。

Great. Congrats for all the progress. So a couple of questions from us. Maybe first, to focus on the U.S. market. So for the XBB filing you already started, so just curious what's left to be submitted? Is that possible you will -- they will -- FDA will need to see XBB clinical data versus the BA 5 data you already have on hand?

偉大的。祝賀所有的進步。我們有幾個問題。也許首先，專注於美國市場。那麼對於您已經開始的 XBB 備案，所以只是好奇還需要提交什麼？您是否可能 - 他們會 - FDA 需要查看 XBB 臨床數據與您手頭已有的 BA 5 數據？

Any risk of supplying to be able to meet all the requirements by late September? Maybe that's one part of the U.S. question. And the other part is the -- what are the key drivers for you to be able to gain meaningful market share in the U.S. for this for specifically, maybe talk about the pricing strategy. And in your 10-Q, we see those presentation is 5 versus 1 dose, any impact from there?

9月下旬之前供應能夠滿足所有要求有風險嗎？也許這就是美國問題的一部分。另一部分是——您能夠在美國獲得有意義的市場份額的關鍵驅動因素是什麼。具體而言，也許可以談談定價策略。在您的 10-Q 中，我們看到這些演示是 5 劑與 1 劑，有什麼影響嗎？

Roger. Filip, would you take Roger's first question, please, on the FDA submission?

羅傑. Filip，您能回答 Roger 關於 FDA 提交的第一個問題嗎？

Sure. So we are submitted the preclinical packages, and we're going to complete that file this month. we previously discussed with the FDA the need for what kind of clinical data we need, and that's why we connected the study we did. The XBB BA 5 data is adequate and not only for the U.S. but globally for approval for XBB 1.5. And our plan is to have the product available in time for the FDA CDC release at the end of September.

當然。因此，我們提交了臨床前包，我們將在本月完成該文件。我們之前與 FDA 討論過我們需要什麼樣的臨床數據，這就是我們將我們所做的研究聯繫起來的原因。 XBB BA 5 數據不僅適用於美國，而且適用於全球批准 XBB 1.5。我們的計劃是在 9 月底 FDA CDC 發佈時及時提供該產品。

Thank you, Filip. And John Trizzino, would you like to take the U.S. commercial?

謝謝你，菲利普。約翰·特里齊諾（John Trizzino），你願意拍攝美國廣告嗎？

Yes. Sure, John. Thank you Roger, thanks. Key drivers have been somewhat outlined in the script, but to review a big piece of this an access strategy, being able to make sure that all markets have -- all market segments have availability to the vaccine.

是的。當然，約翰。謝謝羅傑，謝謝。腳本中已經對關鍵驅動因素進行了一定程度的概述，但要回顧其中的一個重要部分是准入策略，能夠確保所有市場——所有細分市場都可以獲得疫苗。

We've talked about distribution, pharmacy, national, regional, the health care provider offices, public health. These are our key participants in our strategy to make sure that we have the non-mRNA vaccine or protein-based vaccine available and accessible across that entire spectrum.

我們討論了分銷、藥房、國家、地區、醫療保健提供者辦公室、公共衛生。他們是我們戰略的關鍵參與者，以確保我們擁有可用於整個譜系的非 mRNA 疫苗或基於蛋白質的疫苗。

Pricing strategy, we're in line with what's been publicly stated, about $130 of WACC. All of that gets incorporated into a reimbursement strategy that makes us in a competitive lead advantage situation here to be sure that all of that vaccine is being purchased through the normal channels. And as we think about what those normal channels are, it's the normal annual seasonal flu vaccine, means of getting to the health care provider and to the consumer.

定價策略，我們與公開聲明的一致，WACC 約為 130 美元。所有這些都被納入報銷策略中，使我們處於競爭領先優勢的地位，以確保所有疫苗都是通過正常渠道購買的。當我們思考這些正常渠道是什麼時，這是正常的年度季節性流感疫苗，是到達醫療保健提供者和消費者手中的方式。

I think it's critical to understand here that we had very limited access of our vaccine during the last season to government contract purchasing and a late approval of our vaccine. We are now well positioned with inventory to be in warehouses starting in September. The distribution network in place and a strong desire for the consumer market and the health care provider market to be trying the protein-based vaccine.

我認為重要的是要了解，上個季節我們的疫苗獲得政府合同採購的機會非常有限，而且我們的疫苗批准較晚。我們現在已做好準備，庫存將於 9 月份開始存放在倉庫中。分銷網絡的到位以及消費者市場和醫療保健提供者市場嘗試基於蛋白質的疫苗的強烈願望。

Great. Maybe next question is regarding the financials. So very glad to see your financial position improved significantly. And also, Jim, you mentioned on the call, if all the operational plan is successful, you can remove your going concern. That's key for investors, I believe. And maybe just elaborate on that point a little bit when and under what condition you will potentially remove the going concern in the next 12 months?

偉大的。也許下一個問題是關於財務狀況的。非常高興看到您的財務狀況顯著改善。而且，吉姆，你在電話中提到，如果所有運營計劃都成功，你就可以取消你的持續經營。我相信這對投資者來說至關重要。也許只是詳細說明一下這一點，您將在未來 12 個月內何時以及在何種條件下消除持續經營？

Yes. Jim Kelly, you can take that question.

是的。吉姆·凱利，你可以回答這個問題。

Certainly. And you're exactly right that this is an area of high interest for investors, our financial health. We really think we've made significant progress. As you heard us mention, we have of $900 million as of 30 June in both cash and receivables.

當然。你說得很對，這是投資者高度關注的一個領域，即我們的財務健康狀況。我們確實認為我們已經取得了重大進展。正如您所聽到的，截至 6 月 30 日，我們擁有 9 億美元的現金和應收賬款。

And we just announced a really important improvement in our strategic partnership with SK that certainly eliminates further liabilities. When it comes to the going concern, you are correct that it is further disclosed in our 10-Q.

我們剛剛宣布了與 SK 戰略合作夥伴關係的一項非常重要的改進，這無疑消除了進一步的責任。當談到持續經營時，您在我們的 10-Q 中進一步披露了這一點，這是正確的。

And we look forward to providing more updates especially in light of our performance this fall in the updated vaccine commercial marketplace. And I think that's about what we can say right now. I think the -- we're optimistic with our operating plan. We continue to execute well.

我們期待提供更多更新，特別是考慮到我們今年秋天在更新的疫苗商業市場中的表現。我認為這就是我們現在可以說的。我認為——我們對我們的運營計劃持樂觀態度。我們繼續執行得很好。

And then if we do so, that would be in line with our expectations that with the appropriate execution, we endeavor to remove that going concern. So more on that in the future.

如果我們這樣做，這將符合我們的期望，即通過適當的執行，我們將努力消除這種持續經營。未來會有更多相關內容。

Our next question will come from Eric Joseph with JPMorgan.

我們的下一個問題將來自摩根大通的埃里克約瑟夫。

Could you clarify whether the updated XBB vaccine would be available as a single-dose or multi-dose format for the U.S. fall campaign? And I'm also curious to know whether any of the -- whether a single dose format is required by any of the national or regional PBMs? And then I have a follow-up.

您能否澄清更新的 XBB 疫苗是否會以單劑量或多劑量形式用於美國秋季疫苗接種活動？我也很想知道任何國家或地區 PBM 是否需要單劑量形式？然後我有一個後續行動。

Thank you, Eric. John T, do you want to take that one?

謝謝你，埃里克。約翰·T，你想拿那個嗎？

Yes. Yes. Thank you. Yes, we will be providing 5-dose file presentation, which is a reduction from our previous endos. We have been talking about unit dose vials on assessment of what market conditions are looking like.

是的。是的。謝謝。是的，我們將提供 5 劑文件演示，這比我們之前的內鏡有所減少。我們一直在討論單位劑量小瓶的市場狀況評估。

There's -- to be sure that we had sufficient supply and then sufficient timing parameters. The decision was made to go with 5-dose vial. There is no specific prevention from having a multi-dose vial. And the reality is we still have refrigerator stability while others are still being shipped frozen product. ease of administration of the 5-dose vial and certainly making sure that there are no barriers to the use of the 5-dose vial and that's being communicated and coordinated with all of our customers, distributors, pharmacies, health care providers, et cetera. You had a follow-up question?

確保我們有足夠的供應和足夠的時間參數。決定使用 5 劑小瓶。對於服用多劑量小瓶並沒有具體的預防措施。現實情況是，我們的冰箱仍然穩定，而其他人仍在運輸冷凍產品。 5 劑小瓶的給藥方便，當然要確保 5 劑小瓶的使用沒有障礙，並且正在與我們所有的客戶、分銷商、藥房、醫療保健提供者等進行溝通和協調。您還有後續問題嗎？

Yes, it did. That's very helpful. Maybe just picking up on your comments about pricing and you made a note about WACC, but your comments being competitively priced, I guess, what should we be thinking about in terms of discounts or really net price? Is there a range that we should be modeling in the U.S?

是的，它確實。這非常有幫助。也許只是注意到你對定價的評論，並且你對 WACC 做了註釋，但你的評論是有競爭力的定價，我想，我們應該在折扣或真正的淨價方面考慮什麼？我們應該在美國建模的範圍嗎？

Yes. So we're not going to disclose the specific contract pricing terms. But as you can imagine, it's part of the overall access strategy, and contracting strategy across all of these channels that we are making sure that the reimbursement calculations are being taken into consideration for what they are purchasing for, what the health care providers are being reimbursed for, and knowing that, that's an important calculation for that strategy.

是的。因此我們不會透露具體的合同定價條款。但正如你可以想像的那樣，這是整體准入策略的一部分，也是所有這些渠道的承包策略的一部分，我們確保報銷計算考慮到他們購買的目的、醫療保健提供者的情況報銷，並且知道這一點，這是該策略的重要計算。

So contracting across all channels in particular, I've mentioned pharmacy, I've mentioned office space physicians, but office phase positions are in categories of integrated delivery networks, or in physician buying groups. And so therefore, that contracting strategy significantly affects their decision-making.

因此，特別是跨所有渠道簽訂合同，我提到了藥房，我提到了辦公空間醫生，但辦公室階段位置屬於綜合交付網絡或醫生購買團體的類別。因此，承包策略會極大地影響他們的決策。

Final one, if I could. Just speaking a last one here. With respect to the remainder of deliveries under APA in the EU, are you effectively done with distributing the Wuhan strain at this point? Or should there be some through still in the second half of that format?

最後一張，如果可以的話。這裡只講最後一點。關於根據 APA 在歐盟進行的剩餘交付，目前你們是否已經有效地完成了武漢病毒株的分發工作？或者該格式的後半部分應該有一些完整的內容嗎？

I guess if that's not the case to get, what's the timing that you expect to sort of be ready with the XBB strain delivery in that region?

我想如果情況並非如此，您預計在該地區交付 XBB 菌株的準備時間是什麼時候？

Go ahead, John.

繼續吧，約翰。

Yes. So Eric, all of our shipments in the fall will be the variance strain XBD. The different regions have different rollout of the APA. So APAs in EU are finishing up before the end of this year, and we're going to be shipping all that product then Canada, Australia, New Zealand Taiwan, Singapore or all have additional APA shipments to be coming.

是的。所以埃里克，我們秋季的所有發貨都將是方差應變 XBD。不同地區的 APA 部署有所不同。因此，歐盟的 APA 將於今年年底前完成，我們將運送所有這些產品，然後加拿大、澳大利亞、新西蘭、台灣、新加坡或所有其他 APA 即將發貨。

But we're -- in all cases, whether we still have an extension of APAs, there will be ongoing and already in place execution of commercialization strategies, either in the private market or the tender markets. In the script, I made reference to several key markets in the EU that are going to be focused -- our attention will be focused on those markets as we go into the season.

但在所有情況下，無論我們是否仍然延長預約定價安排，商業化戰略都將持續且已經到位，無論是在私人市場還是招標市場。在劇本中，我提到了歐盟的幾個主要市場，這些市場將是我們關注的重點——隨著季節的到來，我們的注意力將集中在這些市場上。

So we understand what those situations are. We also understand, especially in Europe about the Pfizer about the Pfizer settlement in Europe against their contract. However, that still leaves more than sufficient market share available for us to acquire. And again, all those conversations and negotiations are already in process for the future.

所以我們了解這些情況是什麼。我們也了解，特別是在歐洲關于輝瑞公司關于輝瑞公司在歐洲根據其合同達成和解的情況。然而，這仍然為我們留下了足夠多的市場份額可供獲取。再說一遍，所有這些對話和談判都已經在為未來進行。

Our next question will come from Brendan Smith with TD Cowen.

我們的下一個問題將由 TD Cowen 的 Brendan Smith 提出。

So a couple of quick ones from a kind of building on, I think, the last couple of questions. I guess, really, to your point about the APAs, I wanted to also ask if you're still planning to or maybe currently negotiating with any of these governments to try to monetize any of the remaining APAs? Or are you expecting at this point to really just go ahead and fill them fill the rest as is?

我想，我想從最後幾個問題的基礎上提出一些快速的問題。我想，實際上，就您關於預約定價安排的觀點而言，我還想問您是否仍然計劃或可能正在與這些政府中的任何一個進行談判，以嘗試將剩餘的預約定價安排貨幣化？或者您是否期望此時真的繼續並按原樣填充其餘部分？

And then I guess one last question on the remaining supplies of the Wuhan vaccine, if we should maybe expect any, I don't know, potential write-offs or disposal of the existing doses or really what your plan is for any outstanding supplies there as we kind of move into the fall with the XBB booster?

然後我想最後一個問題是關於武漢疫苗的剩餘供應，我不知道我們是否應該預期現有劑量的潛在註銷或處置，或者您對那裡任何未完成供應的計劃是什麼？當我們帶著XBB 助推器進入秋季時？

John, do you want to take the first question on APAs?

約翰，您想回答有關預約定價安排的第一個問題嗎？

Yes. Let me -- actually, I think Eric may have asked the same question, too, and let me just come back to clarify. So for the remainder of shipments to be made for the balance of this year will all be under the variant stream vaccine.

是的。讓我——實際上，我認為埃里克可能也問了同樣的問題，讓我回來澄清一下。因此，今年餘下的剩餘發貨量將全部採用變異流疫苗。

XBB will be what the strain included in the vaccine will be. No additional Wuhan shipments will be made we, for this period of time, have complied with the VRBPAC recommendations of the variant strength to be included. That we will continue to do throughout all of the various regions that we're engaged.

XBB 將是疫苗中包含的菌株。在此期間，我們不會再向武漢發貨，我們已遵守 VRBPAC 對所包含型號強度的建議。我們將在我們參與的所有各個地區繼續這樣做。

The APAs is -- are a little bit different country by country. So no APAs to contend with in the U.S. It's a wholly commercial market. Canada, for example, will continue under the amended APA will continue for '24 and '25 under APA, and we continue to talk with them long term about what their coded vaccine needs are.

各個國家的 APA 略有不同。因此，美國無需應對預約定價安排。這是一個完全商業化的市場。例如，加拿大將繼續遵守修訂後的 APA，並將繼續遵守 APA 的“24 和 25”，我們將繼續與他們長期討論他們的編碼疫苗需求是什麼。

Europe ends with this year, but conversations on a country-by-country basis for what might either be their tender market or private market. And then similarly, with Australia and New Zealand, those APAs have been amended to continue for another 2 years. In every case, the relationships established during the pandemic continue to be strong on a country-by-country basis.

歐洲將於今年結束，但各國正在就招標市場或私人市場進行對話。同樣，澳大利亞和新西蘭的 APA 也經過修改，有效期再延長 2 年。無論如何，疫情期間建立的各國關係仍然牢固。

They've been very cooperative and flexible with us. In all cases, we've retained the full contract value of the APA. So we will either continue to ship updated variant vaccine or manage that through future purchase commitments to be satisfying against those obligations.

他們與我們非常合作且靈活。在所有情況下，我們都保留了 APA 的全部合同價值。因此，我們將要么繼續運送更新的變異疫苗，要么通過未來的購買承諾來履行這些義務。

And then Jim Kelly, the second question on any potential write-offs from Wuhan?

然後是吉姆·凱利，第二個問題是關於武漢可能的註銷嗎？

Yes, exactly. And we don't anticipate any write-offs associated with Wuhan. And I think you noted in our COGS this quarter, I think it's about $2 million in [expiry] and obsolescence.

對，就是這樣。我們預計不會有任何與武漢相關的沖銷。我想您在本季度的 COGS 中註意到，[到期]和過時的成本約為 200 萬美元。

So we've cleared our balance sheet of those items, and we're fully focused on delivering the updated vaccine this fall. I'll just reiterate what John just said about getting all the Wuhan vaccine to our customers. We are fortunate. Our customers requested to have Wuhan delivered by Q2, and we delivered on that. And that was a part of what people are happy to see in our top line this quarter.

因此，我們已經清理了資產負債表中的這些項目，並且我們將完全專注於在今年秋天提供更新的疫苗。我只是重申約翰剛才所說的關於向我們的客戶提供所有武漢疫苗的說法。我們很幸運。我們的客戶要求在第二季度之前將武漢交付，我們就交付了。這是人們很高興在本季度的營收中看到的一部分。

And when you think about our guidance that we've given just in terms of phasing of revenue, we had said, hey, about 1/3 or $500 million we expected before the fall season. Well, we did just that. And so the remaining $800 million to $1 billion is this back half of the year, and we look forward to executing with our updated vaccine.

當你想到我們僅就收入階段性給出的指導時，我們曾說過，嘿，大約是我們在秋季之前預期的 1/3 或 5 億美元。嗯，我們就是這麼做的。因此，剩下的 8 億至 10 億美元是今年下半年的資金，我們期待著使用我們更新的疫苗來執行。

Our next question will come from Mayank Mamtani with B. Riley.

我們的下一個問題將由 Mayank Mamtani 和 B. Riley 提出。

Great to see solid execution against your plan. I appreciate your transparency. Just quickly kind of following up on the prior question around the current liabilities management. We noticed the Gavi update mostly sort of being focused on 2024 in your 10-Q.

很高興看到您的計劃得到切實執行。我很欣賞你的透明度。只是快速跟進之前有關流動負債管理的問題。我們注意到 Gavi 的更新主要集中在 10-Q 中的 2024 年。

I'm just curious, anything additional on that topic, we should hear beyond the color you provided in Canada and with the SK Bio, anything else that could happen on the current liabilities bucket we should be looking out in the near term? And then I have a couple of (inaudible)

我只是很好奇，關於這個話題的任何其他內容，除了您在加拿大和 SK Bio 提供的顏色之外，我們還應該聽到我們在短期內應該關注的當前負債桶上可能發生的任何其他情況？然後我有幾個（聽不清）

Jim. Do you want to comment?

吉姆.你想評論嗎？

We'll certainly. And by the way, thank you for asking this question about current liabilities because it is so important to our financial health as we move forward. When you think about the $864 million that we've eliminated year-to-date and current liabilities and then the incremental $195 million associated with a really important set of agreements with SK Bio. My goodness, what a difference these last months have made as we further strengthen our financial position as a company. We still do have in our, I'll call it, other liabilities, the approximately $700 million associated with Gavi.

我們一定會的。順便說一句，感謝您提出有關流動負債的問題，因為隨著我們的前進，它對我們的財務健康非常重要。想想我們今年迄今已消除的 8.64 億美元和流動負債，以及與 SK Bio 達成的一系列非常重要的協議相關的增量 1.95 億美元。天哪，過去幾個月我們進一步加強了公司的財務狀況，發生了多麼大的變化。我們仍然有（我稱之為其他負債）與 Gavi 相關的大約 7 億美元。

You have heard us say before that we stand by our position that in our dispute that we think the claims are unwarranted. And while we can't -- as policies speak to legal matters, we did share a disclosure that the arbitration hearing has been scheduled for next July 2024.

您之前曾聽我們說過，我們堅持我們的立場，在我們的爭議中，我們認為這些主張是沒有根據的。雖然我們不能——因為政策涉及法律事務，但我們確實披露了仲裁聽證會定於明年 2024 年 7 月舉行的信息。

And so that's all we can share at this time. But certainly, going back to great progress on improving the financial strength of this company and looking forward to giving more and more updates on that front in future calls.

這就是我們目前可以分享的全部內容。但當然，我們還是要回顧一下在提高該公司財務實力方面取得的巨大進展，並期待在未來的電話會議中提供越來越多的這方面的最新信息。

Very helpful. And then maybe to fill in, Filip, quickly on the flu-COVID work ongoing. We saw a major antibody effort, unfortunately failed recently and we've had relatively mixed (inaudible) results from the mRNA, at least for a particular strain subtype.

很有幫助。菲利普，然後也許要快速補充一下正在進行的流感-新冠病毒工作。我們看到了一項主要的抗體工作，不幸的是最近失敗了，並且我們從 mRNA 得到了相對複雜（聽不清）的結果，至少對於特定的菌株亞型來說是這樣。

Could you just talk about, Filip, what you're sort of learning in -- and as you think about late execution for your candidate and obviously, there are distinct advantages that you have with your combination how you might be looking to design that Phase III study?

菲利普，你能談談你正在學習什麼嗎？當你考慮候選人的後期執行時，顯然，你的組合有明顯的優勢，你可能希望設計該階段三、學習？

Yes. So first, I want to remind you that the data that we presented previously was a relatively small data set, right? We compared 11 different formulations. So those had to be bedside mixes.

是的。首先，我想提醒大家，我們之前提供的數據是一個相對較小的數據集，對吧？我們比較了 11 種不同的配方。所以這些必須是床頭混音。

So the whole idea is for this next study, we're going to be testing a co-formulated vaccine which would be the final co-formulated product we're looking at. To develop the safety database, we could actually go into a large Phase III study. We think we're going to have a superior product.

因此，下一項研究的整個想法是，我們將測試一種聯合配方疫苗，這將是我們正在研究的最終聯合配方產品。為了開發安全性數據庫，我們實際上可以進行大型第三階段研究。我們認為我們將擁有更優質的產品。

That's the target product profile, and we aim to prove that with a clinical efficacy Phase III study to follow. Now that being said, the -- our stage gated approach is really to release resources to develop the co-formulation and looking forward in the future, hopefully, to get that Phase IIb study taken care of next year. to increase the value of the asset and really to have assured us that as we go in a Phase III study, we'll have a superior product.

這就是目標產品概況，我們的目標是通過後續的臨床療效 III 期研究來證明這一點。話雖這麼說，我們的階段控制方法實際上是釋放資源來開發複合製劑，並展望未來，希望明年能夠完成 IIb 期研究。增加資產的價值，並真正向我們保證，當我們進行第三階段研究時，我們將擁有更優質的產品。

Okay. Understood. And maybe just one final one for John, if I may. The range -- the U.S. product sales guidance range is fairly broad I was just curious, in terms of timing versus market share versus some of the considerations around price and volume levels, how should we characterize some of that based on your customer later discussion.

好的。明白了。如果可以的話，也許這只是約翰的最後一篇。範圍——美國產品銷售指導範圍相當廣泛，我只是很好奇，就時間安排、市場份額以及圍繞價格和銷量水平的一些考慮因素而言，我們應該如何根據客戶稍後的討論來描述其中的一些特徵。

You obviously haven't done already with GPOs and -- are you able to sort of break down those different variables in terms of how we may excel against that range, which is really broad?

顯然，您還沒有處理過 GPO，並且 - 您是否能夠根據我們如何在這個非常廣泛的範圍內表現出色來分解這些不同的變量？

Yes, John T., do you want to comment?

是的，John T.，您想發表評論嗎？

Yes. Mike, look, I think you're seeing a pretty significant range of estimates on total U.S. market demand probably for good reason in that there's a lot of variability in what's going to be driving market sizing for the fall season.

是的。邁克，聽著，我認為您看到的對美國市場總需求的估計範圍相當大，這可能是有充分理由的，因為推動秋季市場規模的因素存在很大的變化。

You had a lot of vaccine fatigue in the last fall season and a lot of good reason for that. People were into the second or third booster, they were getting told to be vacated get in the fall campaign. It was falling off the headlines. The U.S. government was declaring victory over the pandemic. I think we're in a different situation in this fall campaign.

去年秋季，您對疫苗感到很疲勞，這是有很多充分理由的。人們進入了第二個或第三個助推器，他們被告知要騰出空間參加秋季競選活動。它已經從頭條新聞中消失了。美國政府宣布戰勝疫情。我認為我們在今年秋季競選中的情況有所不同。

We have a new strain of the virus circulating in order to be protected from that new strain or to reduce serious illness from that strain. You need to have this updated vaccine in place. in part, what's going to drive that is information and communication to the consumer and health care providers about the need assistance from the CDC and their communications campaign advising the public as to what to expect.

我們有一種新的病毒株正在傳播，以便免受該新病毒株的侵害或減少該病毒株造成的嚴重疾病。您需要接種這種更新的疫苗。在某種程度上，推動這一趨勢的因素是向消費者和醫療保健提供者提供關於疾病預防控制中心需要援助的信息和溝通，以及他們向公眾提供建議的溝通活動。

And then, of course, it's participation at the pharmacy level, right, plays a significant role going forward in supporting a vaccination, the office-based practitioner engagement with public health, the VFC programs, 317 funds.

當然，藥房層面的參與在支持疫苗接種、辦公室從業人員參與公共衛生、VFC 計劃、317 基金方面發揮著重要作用。

Remember, there's also the Bridge Access Program that's been talked a lot about with Secretary Becerra to make sure we've got coverage for underinsured, no insured, underserved populations. And so I think we're going to watch this play out over the next few weeks and months to decide where that is. As far as our market share is concerned, remember, we had very little participation in the U.S. market last year, unfortunately. And so -- but we have kind of moderate expectations about what we should be able to do. But I think that there is a demonstrated need for mRNA COVID vaccination. They understand the value of a protein-based vaccine. We are the only protein-based vaccine in the U.S. market, and we're going to be talking about choice and choice being important to this market. So we expect to see some market share gains in this fall campaign for sure.

請記住，還有與貝塞拉部長多次討論的橋樑通道計劃，以確保我們為保險不足、沒有保險、服務不足的人群提供保險。因此，我認為我們將在接下來的幾周和幾個月內觀察這一情況的發展，以決定具體情況。就我們的市場份額而言，請記住，不幸的是，去年我們很少參與美國市場。所以——但我們對我們應該做的事情抱有適度的期望。但我認為 mRNA 新冠疫苗接種的需求已得到證實。他們了解基於蛋白質的疫苗的價值。我們是美國市場上唯一基於蛋白質的疫苗，我們將討論選擇和選擇對這個市場的重要性。因此，我們預計在今年秋季的活動中肯定會看到一些市場份額的增長。

Our next question will come from Alec Stranahan with Bank of America.

我們的下一個問題將來自美國銀行的亞歷克·斯特拉納漢 (Alec Stranahan)。

Just a couple from us. First, maybe just a finer point on the expectations around the BLA approval. Is your expectation that going into the fall vaccination cycle that you'll have an ELA in hand?

只有我們幾個人。首先，也許只是對 BLA 批准的期望進行更詳細的闡述。您是否期望在進入秋季疫苗接種週期時您手中會持有 ELA？

And if not, are any of the contract deliveries that you expect contingent on a BLA, ACIP recommendation or MMWR recommendations? And then I've got a follow-up.

如果沒有，您期望的合同交付是否取決於 BLA、ACIP 建議或 MMWR 建議？然後我有一個後續行動。

Go ahead, John T. on that question.

約翰·T，請繼續回答這個問題。

Yes. That's actually a really good question that we want to make sure everybody clearly understand. So we are already in the process of submitting for the BLA. We expect that to be final submission within the coming weeks and months and then a BLA approval in the first quarter of next year.

是的。這實際上是一個非常好的問題，我們希望確保每個人都清楚地理解。因此，我們已經開始提交 BLA。我們預計將在未來幾周和幾個月內完成最終提交，然後在明年第一季度獲得 BLA 批准。

That process does not have a negative or positive effect for the full campaign, right? Constant coordination and communication with FDA. We expect full operating flexibility under the emergency use authorization. That conversation, as I said, has been taking place with the regulators and with the FDA. And so no restrictions across any of our distributors, pharmacies, health care providers because we will have that EUA authorization available to this product from the FDA.

該過程不會對整個活動產生負面或正面影響，對嗎？與FDA持續協調和溝通。我們期望在緊急使用授權下實現充分的運營靈活性。正如我所說，這種對話一直在與監管機構和 FDA 進行。因此，我們的任何經銷商、藥房、醫療保健提供者都沒有受到限制，因為我們將獲得 FDA 對該產品的 EUA 授權。

Okay. Great. And maybe one quick follow-up maybe for Filip. Just in terms of the data that goes into the BLA, what the FDA would want to see for full approval. Is this simply comparability versus the Nuvaxovid on immunogenicity? Or do you need to also demonstrate protection from infection? And if it's the latter, would you be updating the market once this data is available?

好的。偉大的。也許對菲利普來說是一個快速的後續行動。就 BLA 中的數據而言，FDA 希望獲得全面批准。這只是與 Nuvaxovid 在免疫原性方面的可比性嗎？或者您還需要證明可以防止感染嗎？如果是後者，一旦獲得這些數據，您會更新市場嗎？

Yes. So let me be kind of (inaudible) to the BLA itself, is based on the prototype vaccine 2373, the original strain. So that's as John said, is we have a rolling submission and that's going in now. The approval for EUA for the XBB is also going in.

是的。讓我（聽不清）對 BLA 本身說一下，它是基於原型疫苗 2373，即原始毒株。正如約翰所說，我們有一個滾動提交，現在正在進行。 XBB 的 EUA 批准也正在進行中。

As I've said, we've completed a complete clinical role. And the data I showed you today is the key clinical data for authorization of the XBB variant. There's no other data in that file other than the data you saw today. And that's going to be concluded this month with expectation for us to be building product by the end of September for the CDC FDA.

正如我所說，我們已經完成了完整的臨床角色。而我今天給大家展示的數據，就是XBB變種授權的關鍵臨床數據。除了您今天看到的數據之外，該文件中沒有其他數據。這將於本月完成，預計我們將在 9 月底之前為 CDC FDA 生產產品。

Now there's a subsequent supplemental BLA next year, which will wrap all this up into a single file going forward. So at some point next year, we're going to be out of the EUA game and in a straight BLA game with this and all subsequent variants.

現在明年會有一個補充 BLA，它將把所有這些內容打包到一個文件中。因此，在明年的某個時候，我們將退出 EUA 遊戲，並直接進行 BLA 遊戲，並包含此版本和所有後續變體。

(Operator Instructions) Our next question will come from Vernon Bernardino with H.C. Wainwright.

（操作員說明）我們的下一個問題將由 Vernon Bernardino 和 H.C. 提出。溫賴特。

Congrats on the restructuring and positive results on the liabilities. I just wanted to confirm a few things. Just wanted to confirm that the WACC you quoted was $130 and whether that was for a single dose booster type shut? Or is that for the full vaccination regimen? And I have a follow-up.

祝賀重組和負債取得積極成果。我只是想確認一些事情。只是想確認您引用的 WACC 為 130 美元，這是否適用於單劑量加強型？或者這是完整的疫苗接種方案？我有一個後續行動。

So Vernon, that's $130 -- WACC is $130 per dose regardless of presentation. And so therefore, the calculation is based upon WACC reimbursement follows in line with that calculation.

所以 Vernon，這是 130 美元——無論表現如何，WACC 都是每劑 130 美元。因此，計算基於 WACC 報銷，並與該計算一致。

And then, of course, the supporting contracts out to specific health care providers is all part of how that process works.

當然，向特定醫療保健提供者提供支持合同也是該流程運作的一部分。

And how does that work with -- I know some would consider that kind of a premium price. How would that end receptivity with a combination COVID and efovaccine as far as reset to such a vaccine beam somewhat how we desired and then, therefore, also something that's deserving of premium pricing?

這如何運作——我知道有些人會認為這種溢價。就我們所希望的那樣重新設置這種疫苗束而言，這將如何結束對新冠病毒和 efovaccine 組合的接受性，因此也是值得高價的東西？

Yes. I don't know that I would call it premium pricing. You're in the prevention or reduction of illness of a significant severe disease. So the justification for that is based upon pharmacoeconomic modeling that takes a look at the benefit received from the vaccine against the economic burden associated with hospitalization, illnesses out of school, out of work, et cetera, et cetera.

是的。我不知道我會稱之為溢價。您正在預防或減少重大嚴重疾病的發生。因此，這樣做的理由是基於藥物經濟學模型，該模型著眼於從疫苗中獲得的益處與住院、因病失學、失業等相關的經濟負擔。

I think we have a calculation that is reviewed. We're confident that there is a robust cost benefit analysis that supports that way consistent with the other manufacturers. I won't yet comment on where we're going to be pricing strategy for a combo vaccine. But if you do have something based upon the data that we saw from the Phase II, that immunogenicity is robust and better than the leading vaccine in the market and that you also are combining that with a COVID vaccine that has a robust efficacy profile against a severe disease burden that you would expect to see pricing consistent with the economic benefit.

我認為我們已經對計算進行了審查。我們相信有強大的成本效益分析支持這種與其他製造商一致的方式。我還不會評論我們將如何制定組合疫苗的定價策略。但是，如果您確實根據我們從第二階段中看到的數據獲得了一些信息，那麼免疫原性是強大的，並且比市場上領先的疫苗更好，並且您還將其與具有強大功效的新冠疫苗結合起來。嚴重的疾病負擔，您希望看到定價與經濟效益一致。

This will conclude our question-and-answer session. I'd like to turn the conference back over to John for any closing remarks.

我們的問答環節到此結束。我想將會議轉回給約翰做總結髮言。

Just want to say thank you for joining us today, everyone. We appreciate it, and we look forward to sharing further updates with you in the future. Have a great day, everybody.

只是想說謝謝大家今天加入我們。我們對此表示感謝，並期待將來與您分享更多更新。祝大家有美好的一天。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。