Novavax Inc (NVAX) 2023 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Third Quarter 2023 Financial Results and Operational Highlights Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

女士們、先生們，感謝大家的耐心等待，並歡迎參加 Novavax 2023 年第三季財務業績和營運亮點電話會議。 （操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, Erika Schultz. You may begin.

現在我想將會議交給今天的發言人 Erika Schultz。你可以開始了。

Good morning and thank you all for joining us today to discuss our third 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.

早安，感謝大家今天加入我們討論我們 2023 年第三季的營運亮點和財務業績。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訊檔案。

Please turn to Slide 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 and first quarter 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.

請看投影片2。在我們開始準備好的評論之前，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、營運計畫、目標和前景、全年相關的資訊2023 年和2024 年第一季的財務指引、Novavax 成本削減計畫的金額和影響、未來的財務或業務績效狀況或策略、合作夥伴關係、未來監管備案和行動的預期時間和結果，以及持續的開發行銷機會、製造我們候選疫苗的產能和未來可用性，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 could cause actual results to differ materially from those projected in such statements. Additional information regarding these factors appears under the heading Cautionary Note Regarding Forward-looking Statements, in the 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. The forward-looking statements in this presentation speak only as of the original date of this presentation, and we undertake no obligation to update or revise any of these statements.

本簡報中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有重大差異。有關這些因素的更多資​​訊出現在我們今天早上發布的幻燈片中的「有關前瞻性陳述的警示說明」標題下，以及我們向證券和證券交易委員會提交的最新表格10-K 和隨後的表格10 -Q 中的「風險因素」標題下。交易委員會，可在 www.sec.gov 和我們的網站 novavax.com 以及隨後向 SEC 提交的文件中取得。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. Joining me today is John Jacobs, our President and CEO, who will provide an update on our progress during the quarter for our 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 clinical development and pipeline. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results.

請參閱幻燈片 3。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)，他將提供本季度我們 3 個關鍵優先事項的最新進展。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資訊。研發總裁 Filip Dubovsky 博士將討論我們的臨床開發和產品線。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. Please turn to Slide 4.

我現在想將電話轉交給約翰·雅各布斯。請翻到幻燈片 4。

Thank you, Erika, and thank you, everyone, for joining us today. I'm pleased to be here today along with the members of our executive team to discuss our third quarter 2023 financial results and operating highlights, and the important progress we've made across our 3 priorities.

謝謝艾莉卡，也謝謝大家今天加入我們。我很高興今天與我們的執行團隊成員一起討論我們的 2023 年第三季財務業績和營運亮點，以及我們在 3 個優先事項方面取得的重要進展。

Let's begin with our first priority, delivering an updated product for the current fall vaccination season. Beginning with our launch in the U.S. and subsequent approval in the EU, we've demonstrated our ability to update our COVID-19 vaccine with seasonal strain changes, and we are focused on commercial execution to gain market share and to deliver on our APA commitments.

讓我們從首要任務開始，為當前的秋季疫苗接種季節提供更新的產品。從我們在美國推出並隨後在歐盟獲得批准開始，我們已經證明了我們有能力透過季節性病毒株變化來更新我們的COVID-19 疫苗，並且我們專注於商業執行，以贏得市場份額並兌現我們的APA 承諾。

In the U.S., we started the season approximately 3 weeks ago with the shipment of doses to major retail pharmacies. We achieved our prelaunch goal of securing broad access to our vaccine, the only protein-based non-mRNA option in the country. Having launched several weeks after the competitor vaccines, we have limited preliminary data, and although early, we are seeing indicators of increased awareness and growing interest in our vaccine.

在美國，我們大約三週前開始了銷售季，並向主要零售藥局運送了劑量。我們實現了啟動前的目標，確保我們的疫苗得到廣泛使用，這是該國唯一基於蛋白質的非 mRNA 疫苗。在競爭對手的疫苗推出幾週後，我們的初步數據有限，儘管還處於早期階段，但我們看到了人們對我們的疫苗的認識和興趣不斷增強的跡象。

In Europe, Nuvaxovid was approved in October. We are also awaiting authorization in Canada, U.K., Australia and New Zealand. In these markets, we have advanced purchase agreements under which we expect to deliver all of the contracted doses for the '23-'24 season. Given the U.S. launch of our vaccine in mid-October, we believe it's too early to assess the true market uptake at this point in time.

Nuvaxovid 於 10 月在歐洲獲得批准。我們還在等待加拿大、英國、澳洲和紐西蘭的授權。在這些市場中，我們已提前簽訂採購協議，預計將在 23-24 季交付所有合約劑量。鑑於我們的疫苗已於 10 月中旬在美國上市，我們認為現在評估真實的市場吸收還為時過早。

Market wide, we have seen lower-than-expected COVID-19 vaccine demand. Given the uncertainty in the U.S. market and approval in Europe several weeks behind our competitors, we expect to deliver revenue at the low end of our prior guidance for the season with some of the revenue expected to shift into the first quarter of 2024. Importantly, we did not originally expect any revenue to occur in Q1 of 2024. Jim Kelly will provide more context on this later in the call.

就整個市場而言，我們看到 COVID-19 疫苗需求低於預期。鑑於美國市場的不確定性以及歐洲的批准晚於競爭對手幾週，我們預計本季的收入將處於我們先前指導的低端，部分收入預計將轉移到 2024 年第一季。重要的是，我們最初預計2024 年第一季不會有任何收入。吉姆凱利(Jim Kelly) 將在稍後的電話會議中提供更多相關背景資訊。

Our management team is leaning into and focusing on our opportunity to create a robust and sustainable business platform for years to come, which includes an optimized and differentiated product presentation in 2024 and 2025, as well as additional restructuring to create a more efficient business model, which will facilitate the late-stage development of and a smooth transition to the anticipated launch of our combination COVID-19-Influenza vaccine in 2026. We believe that a combination COVID-19-Influenza vaccine represents a significant opportunity in this market, which is why we are concentrating our portfolio investments to bring forward our unique protein-based combination vaccine, which is likely to be a preferred option for many consumers and health care providers.

我們的管理團隊正在關注並專注於我們在未來幾年創建強大且可持續的業務平台的機會，其中包括在2024 年和2025 年進行優化和差異化的產品展示，以及進行額外的重組以創建更高效的業務模式，這將有助於我們預計於2026 年推出的COVID-19-流感聯合疫苗的後期開發和平穩過渡。我們相信，COVID-19-流感聯合疫苗代表了這個市場的重大機會，為什麼我們集中投資組合來推出我們獨特的基於蛋白質的組合疫苗，這可能是許多消費者和醫療保健提供者的首選。

Now 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. In the quarter, we continued to make significant progress on our commitment to improve our financial position while maintaining the capabilities to support long-term value creation.

現在讓我們繼續討論第二個優先事項，即降低我們的支出率，管理我們的現金流，並發展我們的規模和結構。本季度，我們在改善財務狀況的承諾上繼續取得重大進展，同時保持支持長期價值創造的能力。

Year-to-date results include a $950 million reduction to operating expenses versus 2022, and in addition, an approximate $1 billion reduction to current liabilities from our December '22 baseline. We are on track to exceed our previously announced global restructuring and cost reduction plan for 2023 by over $100 million for combined R&D and SG&A expenses, while at the same time, having successfully achieved our objective of updating our vaccine and launching this season, demonstrating that we can significantly reduce cost while maintaining our core capabilities.

年初至今的表現包括與 2022 年相比營運費用減少了 9.5 億美元，此外，與我們 22 年 12 月的基準相比，流動負債減少了約 10 億美元。我們預計將超額完成先前宣布的 2023 年全球重組和成本削減計劃，研發和銷售、一般管理費用合計將超過 1 億美元，同時成功實現了更新疫苗並在本季推出的目標，這表明：我們可以在保持核心能力的同時顯著降低成本。

While this reduction was an important step, there are more efficiencies we can achieve. And we are prepared to further reshape and size the scope of our operations beyond previously announced 2024 targets to align with the emerging COVID market opportunity, while advancing our COVID-flu combination vaccine program. Therefore, we are prepared to initiate additional cost reductions to decrease 2024 expenses by over $300 million, above and beyond the previously stated targets for 2024. Jim Kelly will speak further about our 2023 guidance and plan to drive significant improvements to our cost structure later in the call.

雖然這項減少是重要的一步，但我們還可以提高效率。我們準備在先前宣布的 2024 年目標之外，進一步重塑和擴大我們的業務範圍，以適應新興的新冠病毒市場機遇，同時推進我們的新冠病毒流感聯合疫苗計劃。因此，我們準備啟動額外的成本削減，以將2024 年的開支減少超過3 億美元，超出之前規定的2024 年目標。吉姆·凱利(Jim Kelly) 將進一步談論我們的2023 年指導，併計劃在稍後推動我們的成本結構的重大改進。的電話。

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. Our recombinant protein-based nanoparticle technology platform and Matrix-M adjuvant have the potential to produce a variety of differentiated vaccines. Our priority here is to focus our R&D investment and resources on bringing forward our protein-based COVID-Influenza combination vaccine product.

最後，讓我們討論優先事項#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 以外的附加價值。我們的基於重組蛋白的奈米顆粒技術平台和Matrix-M佐劑具有生產多種差異化疫苗的潛力。我們的首要任務是集中研發投資和資源，推出以蛋白質為基礎的新冠肺炎聯合疫苗產品。

As Filip will discuss later in the call, contingent upon FDA concurrence on an accelerated approval pathway, we are now planning to move directly into Phase III in 2024 and to fund this program independently. Initiating a Phase III program in '24 would enable a potential launch in the United States in 2026.

正如 Filip 稍後將在電話會議中討論的那樣，根據 FDA 對加速審批途徑的同意，我們現在計劃於 2024 年直接進入 III 期，並獨立資助該專案。 2024 年啟動第三階段計畫將有可能在 2026 年在美國推出。

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 to discuss our commercial updates. John?

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？

Thank you, John. Please turn to Slide 6. As John outlined, in the U.S., we are approximately 3 weeks into our season launch. We are pleased that we have secured broad access to our vaccine through contracts with the majority of major retailers, including Costco, CVS, Giant, Publix, Rite Aid and Stop & Shop, as well as top integrated delivery networks and major medical groups across the country. To date, the retail channel is the largest segment of the market with approximately 90% of COVID-19 vaccinations thus far, and availability of product was prioritized by distributors in the retail setting.

謝謝你，約翰。請參閱幻燈片 6。正如 John 所概述的那樣，在美國，我們的賽季推出已經大約 3 週了。我們很高興透過與大多數主要零售商（包括 Costco、CVS、Giant、Publix、Rite Aid 和 Stop & Shop）以及全球頂級綜合配送網絡和主要醫療集團簽訂合同，確保我們的疫苗得到廣泛使用。國家。迄今為止，零售通路是市場最大的部分，迄今為止約 90% 的 COVID-19 疫苗接種都是透過零售通路進行的，並且零售環境中的分銷商優先考慮產品的供應。

Looking at the flu market, we see that the retail to non-retail channel split is currently approximately 65-35, which mirrors prior years. Therefore, we can reasonably expect that non-retail channel for COVID-19, which includes health care provider offices, could grow through the end of the year.

縱觀流感市場，我們發現零售通路與非零售通路的比例目前約為 65-35，這與前幾年的情況相同。因此，我們可以合理地預期，包括醫療保健提供者辦公室在內的 COVID-19 非零售通路可能會在今年年底成長。

Please turn to Slide 7. In the U.S., we have seen a slower season start than 2022 for COVID. At this point, last season, just over half of COVID vaccines had been administered. So we expect that a significant market opportunity could remain with the potential to extend the season into the first quarter. However, we believe that multiple factors are leading to slower-than-anticipated vaccine uptake this fall, including distribution challenges in the U.S. market as it is converted from government purchase to commercial. The availability of multiple vaccines, COVID, flu, RSV and updated pneumococcal for the first time in the same season. Trailing vaccine fatigue from the pandemic amongst others.

請參閱投影片 7。在美國，我們發現新冠肺炎季節的開始速度比 2022 年慢。上個賽季此時，已經接種了略多於一半的新冠疫苗。因此，我們預計，重要的市場機會仍然存在，並有可能將產季延長至第一季。然而，我們認為多種因素導致今年秋季疫苗的使用速度慢於預期，其中包括美國市場從政府購買轉向商業購買時面臨的分銷挑戰。首次在同一季節提供多種疫苗、新冠肺炎、流感、呼吸道合胞病毒和更新的肺炎鏈球菌疫苗。流感大流行等導致疫苗疲倦。

Based upon the data available to date and without a significant trend break, it is our estimate that the U.S. market could be as low as 30 million doses or as high as 50 million doses should we see a trend break pickup from other channels or an elongated vaccination season that goes into the first quarter. We are expecting lower-than-anticipated sales in the U.S. market due to these and other factors. Jim will provide more information during his section.

根據迄今為止可獲得的數據，在沒有重大趨勢突破的情況下，我們估計，如果我們看到其他管道出現趨勢突破或長期增長，美國市場的劑量可能低至3000 萬劑，或高達5000 萬劑.疫苗接種季節進入第一季。由於這些因素和其他因素，我們預期美國市場的銷售額將低於預期。吉姆將在他的部分提供更多資訊。

Importantly, we do not believe that the 2023 market will be representative of the future opportunity, including combination-vaccine options in the future; and C, the COVID market providing a growing and sustainable revenue opportunity for Novavax for years to come.

重要的是，我們不認為 2023 年市場將代表未來的機會，包括未來的組合疫苗選擇； C，新冠肺炎市場為 Novavax 在未來幾年提供了不斷成長且可持續的收入機會。

Please turn to Slide 8. We are encouraged that our vaccine is now available in the U.S. alongside mRNA options, offering consumers and health care providers a choice this season. While we are currently seeing low single-digit market share, which is consistent with analogs for third to market products in their early stages of their launch, we believe that it is too early to assess our full 2023 potential.

請參閱幻燈片 8。我們感到鼓舞的是，我們的疫苗現已在美國與 mRNA 選項一起上市，為消費者和醫療保健提供者在本季節提供了選擇。雖然我們目前看到的市佔率較低，為個位數，這與第三個市場產品在推出初期的類似情況一致，但我們認為，現在評估我們 2023 年的全部潛力還為時過早。

We are seeing some early indicators that where we are positioned on a level-playing field and fully stocked and available, we can effectively compete. For example, based on recent feedback in a select national retailer, we have achieved up to 10% market share in our first few weeks of launch. We anticipate market share improvement over the course of this season based upon both consumer and HCP demand for our vaccine as the only protein-based non-mRNA COVID-19 vaccine option. Its refrigerator-stable product profile and ease of use and market research showing that around 25% to 30% of consumers and health care professionals prefer a protein-based option.

我們看到一些早期跡象表明，如果我們處於公平競爭的環境中，並且庫存充足且可用，我們就可以有效地競爭。例如，根據一家選定的全國性零售商最近的回饋，我們在推出後的最初幾週內就獲得了高達 10% 的市場份額。根據消費者和 HCP 對我們疫苗作為唯一基於蛋白質的非 mRNA COVID-19 疫苗選擇的需求，我們預計本季的市場份額將有所改善。其冰箱穩定的產品簡介和易用性以及市場研究表明，約 25% 至 30% 的消費者和醫療保健專業人士更喜歡基於蛋白質的選擇。

Please turn to Slide 9. Given the high proportion of vaccinations we are seeing in the retail channel, we are currently focused on driving market share in this channel, working with pharmacies to promote the availability of our vaccine both in their online scheduling systems and in store, and we'll continue to work to stimulate new demand in the non-retail channels. We are also focusing on executing highly targeted direct-to-consumer education and public relations efforts to drive the Novavax brand name and awareness and drive consumers to locations with availability of Novavax's vaccine.

請參閱投影片9。鑑於我們在零售通路看到的疫苗接種比例很高，我們目前的重點是提高該通路的市場份額，與藥局合作，在其線上調度系統和零售通路中推廣我們疫苗的供應。店，我們將繼續努力刺激非零售通路的新需求。我們也專注於執行高度針對性的直接面向消費者的教育和公共關係工作，以提高 Novavax 的品牌知名度和知名度，並吸引消費者前往可以購買 Novavax 疫苗的地點。

Just 3 weeks into our in-season promotional efforts, we have seen substantial lifts in awareness of Novavax. The HCP-aided awareness increasing from 46% to 72%. And we are seeing that within retail, in over half our retail outlets that offer the Novavax vaccine, it is offered as 1 of only 2 COVID-19 vaccines available.

季節性促銷活動剛開始 3 週，我們就看到 Novavax 的知名度大幅提升。 HCP 幫助下的意識從 46% 提高到 72%。我們發現，在零售領域，超過一半提供 Novavax 疫苗的零售店將其作為僅有的 2 種 COVID-19 疫苗中的一種。

Please turn to Slide 10. Outside of the U.S., our 2023 product sales continue to be driven by our existing APAs. In the EU, we received approval and expect to deliver all of the remaining committed doses. In other key markets, including in the U.K., Canada, Switzerland, Australia, New Zealand, Singapore, Taiwan and WHO regions, we are awaiting regulatory authorization. Based on committed dose delivery schedules and subject to those regulatory approvals, we expect to deliver all APA doses for the '23, '24 season.

請參閱投影片 10。在美國以外的地區，我們 2023 年的產品銷售將繼續由現有的 APA 推動。在歐盟，我們獲得了批准，並預計將交付所有剩餘的承諾劑量。在其他主要市場，包括英國、加拿大、瑞士、澳洲、紐西蘭、新加坡、台灣和世界衛生組織地區，我們正在等待監管機構授權。根據承諾的劑量交付時間表並根據這些監管部門的批准，我們預計將在 23、24 季節交付所有 APA 劑量。

Please turn to Slide 11. I want to reiterate, we believe that this season is a transitional one both for the size of the market opportunity and our market share potential and that long term, both the COVID-19 market and our ability to penetrate to penetrate the market, represent a significant ongoing opportunity for our company.

請轉到幻燈片11。我想重申，我們相信，無論是對於市場機會的規模還是我們的市場份額潛力而言，本季度都是一個過渡時期，從長遠來看，無論是對於COVID-19 市場還是我們滲透到市場的能力而言，本季都是一個過渡時期。滲透市場，對我們公司來說是一個重大的持續機會。

Early feedback from our launch has reinforced our belief that there is a demand for a differentiated vaccine option and that Novavax will play a meaningful role with potential product sales for Nuvaxovid alone between the U.S. and rest of world projected to be greater than $1 billion opportunity annually. This should provide a foundation for us to advance our pipeline, leading with our combination Influenza-COVID vaccine, which when combined with our stand-alone COVID-19 vaccine has the potential to be a multibillion-dollar respiratory vaccine franchise in the future.

我們推出的早期反饋增強了我們的信念，即存在對差異化疫苗選擇的需求，並且Novavax 將發揮有意義的作用，僅Nuvaxovid 在美國和世界其他地區之間的潛在產品銷售額預計每年將超過10億美元。這應該為我們推進我們的管道奠定基礎，以我們的流感-COVID 聯合疫苗為主導，該疫苗與我們獨立的COVID-19 疫苗結合使用時，有可能在未來成為價值數十億美元的呼吸道疫苗系列。

And with that, I would now like to hand it over to Filip to discuss updates for R&D.

至此，我現在想將其交給 Filip 討論研發的更新。

Thanks, John. Please turn to Slide 12. Today, I will cover a couple of topics. The progress in our COVID-Influenza combination program and how we're expanding the use of Matrix-M adjuvant. These topics exemplify different approaches to capitalizing on our core technology.

謝謝，約翰。請參閱投影片 12。今天，我將討論幾個主題。我們的 COVID-流感聯合計劃的進展以及我們如何擴大 Matrix-M 佐劑的使用。這些主題舉例說明了利用我們的核心技術的不同方法。

I came to Novavax after seeing the original nanoparticle plus Matrix-M publications for influenza and understood the promise of the technology. This has been validated by the development, licensure and commercialization of our COVID vaccine, the exact same technology is used in our combination vaccine.

在看到用於流感的原始奈米顆粒加 Matrix-M 出版物並了解該技術的前景後，我來到了 Novavax。我們的新冠疫苗的開發、授權和商業化已經驗證了這一點，我們的聯合疫苗也使用了完全相同的技術。

Please turn to Slide 13 for an update on the COVID-Influenza combination vaccine. As we previously discussed, the combination vaccine program is a priority because it has the potential to be a preferred product by consumers and health care providers. Previously, we evaluated 11 discrete formulations, and we've now selected the formulation to advance into the next study.

請參閱投影片 13，以了解新冠肺炎-流感合併疫苗的最新資訊。正如我們之前討論的，聯合疫苗計劃是一個優先事項，因為它有可能成為消費者和醫療保健提供者的首選產品。先前，我們評估了 11 種離散配方，現在我們選擇了進入下一項研究的配方。

I'm displaying neutralization responses on this slide. Neutralization responses are important because we believe they most closely predict clinical efficacy. On the left side of the slide are COVID-neutralization responses and the right influenza-neutralization responses for the 3 strains that will be included in future Influenza vaccines. Our selected formulation compares well to Nuvaxovid as well as Fluzone High-Dose and FLUAD.

我在這張投影片上顯示中和反應。中和反應很重要，因為我們相信它們最能預測臨床療效。幻燈片左側是未來流感疫苗中將包含的 3 種病毒株的新冠病毒中和反應和右側流感中和反應。我們選擇的配方與 Nuvaxovid 以及 Fluzone High-Dose 和 FLUAD 相當。

Separately, we compared the geometric mean ratios of the HAI responses to these formulations. They achieved noninferiority margins previously used in the Phase III studies, paving the road toward late-stage development. I also want to remind you, we observed a favorable reactogenicity profile with our combination vaccine that was clinically indistinguishable from the licensed Influenza vaccine comparators. This appears to be a hallmark of our technology, we can increase the antigen load while maintaining acceptable tolerability.

我們分別比較了 HAI 響應與這些配方的幾何平均比率。他們實現了先前在第三階段研究中使用的非劣效性界限，為後期開發鋪平了道路。我還想提醒您，我們觀察到我們的組合疫苗具有良好的反應原性，這在臨床上與許可的流感疫苗比較劑沒有區別。這似乎是我們技術的一個標誌，我們可以增加抗原負載，同時保持可接受的耐受性。

Overall, this points to a favorable product profile demonstrating both a convenience factor of a 2 in 1 vaccine, coupled with the reactogenicity profile comparable to licensed Influenza vaccines. Formulation development is ongoing, and we are still on track to initiate the next study in 2024. Pending final regulatory concurrence, we've designed the study to evaluate endpoint for an accelerated approval pathway while simultaneously building a co-formulate safety database. Therefore, we've updated the next year's study designation to a Phase III study.

總體而言，這顯示了良好的產品概況，展示了二合一疫苗的便利因素，以及與許可的流感疫苗相當的反應原性概況。製劑開發正在進行中，我們仍有望在 2024 年啟動下一項研究。在等待最終監管同意之前，我們設計了這項研究來評估加速審批途徑的終點，同時建立共同製定的安全資料庫。因此，我們已將明年的研究名稱更新為 III 期研究。

Please turn to Slide 14 to talk about Matrix-M. But first, let me remind you about the adjuvant's performance characteristics. Matrix-M induces high levels of broadly neutralizing antibody, a long-lived polyfunctional CD4 cellular response, and is antigen sparing, which may be appealing for companies that have difficult to manufacture antigens. As a component of our COVID vaccine, it is a large and well-characterized safety database.

請翻到投影片 14 來談談 Matrix-M。但首先，讓我提醒您有關佐劑的性能特徵。 Matrix-M 誘導高水平的廣泛中和抗體，這是一種長壽命的多功能 CD4 細胞反應，並且是抗原節約型，這對於難以製造抗原的公司來說可能很有吸引力。作為我們的新冠疫苗的組成部分，它是一個大型且特徵明確的安全資料庫。

And as we've previously discussed, even large quantities of antigen, it maintains a reactogenicity profile consistent with licensed vaccines.

正如我們之前討論的，即使是大量抗原，它也能保持與許可疫苗一致的反應原性。

We pursued multiple approaches to increase the adjuvant's value. It's included in veterinary vaccines commercialized by MSD Animal Health and Intervacc in Europe with additional vaccines in development. It's included in the R21 malaria vaccine that has recently received WHO SAGE recommendations for use. As we have previously announced, it's in preclinical evaluation by the Bill & Melinda Gates Medical Research Institute for targets of public health importance. And in addition to its use in our own pipeline products, it is being evaluated as a component in 12 clinical stage candidates by biotech, academic and government partners.

我們採取了多種方法來提高佐劑的價值。它被納入 MSD Animal Health 和 Intervacc 在歐洲商業化的獸用疫苗中，其他疫苗正在開發中。它包含在 R21 瘧疾疫苗中，該疫苗最近收到了 WHO SAGE 的使用建議。正如我們先前宣布的，比爾及梅琳達蓋茲醫學研究所正在對它進行臨床前評估，以評估具有公共衛生重要性的目標。除了在我們自己的管道產品中使用之外，生物技術、學術界和政府合作夥伴還正在將其作為 12 個臨床階段候選藥物的組成部分進行評估。

And finally, it's being evaluated in animal models by a biopharma partner to improve currently authorized vaccines against herpes and respiratory viruses. As these projects mature, it will expand the Matrix performance data set, and if these projects are successful, unlock additional value. These external Matrix-M collaborations represent opportunities for long-term future of Novavax and do not distract us from our top focus on the development of the combination COVID-Influenza vaccine.

最後，生物製藥合作夥伴正在動物模型中進行評估，以改善目前授權的皰疹和呼吸道病毒的疫苗。隨著這些專案的成熟，它將擴大 Matrix 效能資料集，如果這些專案成功，將釋放額外的價值。這些外部 Matrix-M 合作代表了 Novavax 長期未來的機遇，並且不會分散我們對新冠肺炎聯合疫苗開發的首要關注。

Please turn to Slide 15, and I'll lay out our planned timelines for the combination-vaccine program. For the COVID-Influenza combination vaccine program, we've selected our dose and are developing our formulation and finalizing our manufacturing strategy. Pending regulatory concurrence, we are anticipating initiating the accelerated approval Phase III study in the second half of 2024. This implies a regulatory filing in 2025, which could allow for us to participate in the fall 2026 season, if development goes smoothly.

請參閱投影片 15，我將列出我們組合疫苗計畫的計畫時間表。對於新冠肺炎-流感聯合疫苗項目，我們已經選擇了劑量，正在開發配方並最終確定我們的生產策略。在等待監管部門同意之前，我們預計將在 2024 年下半年啟動加速批准的 III 期研究。這意味著將在 2025 年向監管機構提交申請，如果開發進展順利，我們可以參與 2026 年秋季的研究。

Okay. Let me hand it over to Jim to discuss our financial results.

好的。讓我把它交給吉姆來討論我們的財務表現。

Thank you, Filip. Please turn to Slide 17. Before discussing our third quarter financial performance, I would like to first share updates on 3 important financial themes to drive shareholder value.

謝謝你，菲利普。請參閱投影片 17。在討論我們第三季的財務表現之前，我想先分享 3 個重要財務主題的最新動態，以推動股東價值。

Today, we are sharing our updated financial guidance that includes our expectation to achieve total revenue for the COVID 2023, '24 season of $1.3 billion, reflecting the lower end of our prior guidance range of $1.3 billion to $1.5 billion, which was for the full year 2023. For updated total revenue guidance, we have combined the full year 2023 and the first quarter of 2024 total revenue to reflect the full delivery timing and revenue recognition of sales associated with the 2023-2024 vaccination season.

今天，我們分享了最新的財務指引，其中包括我們預計2023 年24 季的總收入將達到13 億美元，反映了我們之前13 億至15 億美元指引範圍的下限，該區間涵蓋了整個季度的收入。2023 年。對於更新的總收入指引，我們合併了 2023 年全年和 2024 年第一季的總收入，以反映與 2023-2024 年疫苗接種季相關的完整交付時間和銷售收入確認。

Consistent with 2023, we originally expected no product sales revenue in the first quarter of 2024. However, due to the delayed start to and expectation for a longer season in the U.S., we expect some portion of revenue recognition will extend into the first quarter of 2024. In addition, outside of the U.S., some portion of the committed APA dose deliveries may extend into the first quarter of 2024.

與 2023 年一致，我們最初預計 2024 年第一季不會有產品銷售收入。然而，由於美國開工時間推遲以及預期更長，我們預計部分收入確認將延續到 2024 年第一季。2024 年。此外，在美國境外，部分APA 劑量交付可能會延續到2024 年第一季。

Therefore, our guidance now includes our expectation for approximately $1 billion for the full year 2023 total revenues, and approximately $300 million of sales in the first quarter of 2024. This updated total revenue guidance of $1.3 billion reflects a lower U.S. sales estimate based on current market expectations, offset by $150 million in favorability in our APAs plus grants and royalties.

因此，我們的指導現在包括我們對2023 年全年總收入約10 億美元的預期，以及2024 年第一季約3 億美元的銷售額。這項更新後的總收入指引為13 億美元，反映了基於當前美國銷售預測的較低水平。我們的 APA 中 1.5 億美元的優惠加上贈款和特許權使用費抵消了市場預期。

As noted earlier, our management team is leaning into and focusing on our opportunity to create a robust and sustainable business platform for years to come. While we're pleased to be over $100 million ahead in our previously announced cost reduction efforts for R&D and SG&A for the full year 2023. We are prepared to initiate additional cost reductions to decrease expenses by over $300 million in 2024 beyond our existing targets.

如前所述，我們的管理團隊正在關注並專注於我們在未來幾年創建強大且可持續的業務平台的機會。雖然我們很高興在先前宣布的2023 年全年研發和銷售管理費用削減工作中提前超過1 億美元，但我們準備啟動額外的成本削減，以在2024 年將開支減少超過3 億美元，超出我們現有的目標。

Regarding cash and APAs, we have over $960 million across cash, accounts receivable as of the third quarter 2023, plus expected cash from the contingent Canadian payment. In addition, we will have $750 million in APA contract value post the 2023, '24 season deliveries. As we move forward, our U.S. market opportunity along with this combination of APA sales, aggressively reducing costs and managing our cash key financial levers to drive towards profitability and long-term shareholder value.

關於現金和預約定價安排，截至 2023 年第三季度，我們擁有超過 9.6 億美元的現金、應收帳款，加上加拿大或有付款的預期現金。此外，在 2023 年 24 季交付後，我們將獲得價值 7.5 億美元的 APA 合約。隨著我們的前進，我們的美國市場機會以及 APA 銷售的結合，積極降低成本並管理我們的現金關鍵財務槓桿，以推動盈利和長期股東價值。

Please turn to Slide 18. Turning now to our third quarter 2023 highlights. For the third quarter of 2023, we recorded $187 million in total revenue. The $165 million in grant revenue recognized during the quarter puts Novavax on track to realize the full value of the $1.8 billion funding under our U.S. government agreement. The decrease in total revenue quarter-over-quarter compared to the prior year was consistent with our expectations for a later start for the 2023, '24 COVID vaccination season.

請轉到幻燈片 18。現在轉到我們的 2023 年第三季亮點。 2023 年第三季度，我們的總營收為 1.87 億美元。本季確認的 1.65 億美元補助收入使 Novavax 預計將實現我們與美國政府協議下 18 億美元資金的全部價值。與前一年相比，總收入環比下降與我們對 2023 年 24 世紀新冠疫苗接種季較晚開始的預期一致。

Combined R&D and SG&A expenses for the third quarter of 2023 were $213 million. This reflects a $214 million or 50% decrease compared to the third quarter of 2022 and includes a $58 million benefit associated with a manufacturing settlement. Year-to-date results highlight a $950 million or 47% reduction in total expenses and an additional approximate $1 billion reduction to current liabilities.

2023 年第三季的研發與銷售、一般行政費用合計為 2.13 億美元。這反映出與 2022 年第三季相比減少了 2.14 億美元，即 50%，其中包括與製造和解相關的 5,800 萬美元收益。年初至今的業績突顯，總支出減少了 9.5 億美元，即 47%，流動負債還減少了約 10 億美元。

Please turn to Slide 19. A few comments regarding the more detailed review of our third quarter 2023 results. Our operating expenses in the current period include the $79 million favorable impact associated with the previously announced SK Bioscience settlement of certain manufacturing liabilities that is recorded to both cost of goods sold and R&D expense.

請參閱投影片 19。關於對 2023 年第三季業績進行更詳細審查的一些評論。我們本期的營運支出包括與先前宣布的 SK Bioscience 解決某些製造負債相關的 7,900 萬美元有利影響，該影響計入銷售成本和研發費用。

Our cost of sales for the third quarter of 2023 were $99 million compared to $435 million in the third quarter of 2022. Third quarter 2023 cost of sales included $82 million related to excess, obsolete or expired inventory and losses on firm purchase commitments as compared to $249 million in the same period in 2022. For the third quarter of 2023, we recorded a net loss of $131 million as compared to a net loss of $169 million in the third quarter of 2022.

我們2023 年第三季的銷售成本為9,900 萬美元，而2022 年第三季為4.35 億美元。2023 年第三季的銷售成本包括與過剩、過時或過期庫存以及確定採購承諾損失相關的8,200 萬美元。2022 年同期淨虧損為 2.49 億美元。2023 年第三季度，我們錄得淨虧損 1.31 億美元，而 2022 年第三季度淨虧損為 1.69 億美元。

Please turn to Slide 20. As noted, we are prepared to initiate additional cost reductions to decrease expenses by over $300 million and further reshape the size and scope of business operations to align with the COVID market opportunity. We plan to do so by reducing 2024 R&D and SG&A expenses by over $200 million compared to prior targets to reflect $750 million or lower spend in 2024. In addition, we intend to reduce supply network costs by over $100 million as we continue to rationalize our manufacturing footprint.

請參閱投影片 20。如前所述，我們準備啟動額外的成本削減措施，以減少超過 3 億美元的開支，並進一步重塑業務營運的規模和範圍，以適應新冠疫情的市場機會。為此，我們計劃將2024 年的研發和銷售及管理費用比之前的目標減少2 億多美元，以反映2024 年7.5 億美元或更少的支出。此外，隨著我們繼續合理化我們的業務，我們打算將供應網路成本減少1 億多美元。製造足跡。

Please turn to Slide 21. Now turning to financial guidance. We're providing some additional details related to our full year 2023 financial guidance and total revenue guidance for the first quarter of 2024. Our total updated revenue guidance for the combined full year 2023 and first quarter 2024 of $1.3 billion reflects $850 million for product sales and $450 million related to grants and royalties.

請轉向投影片 21。現在轉向財務指導。我們將提供與2023 年全年財務指引和2024 年第一季總收入指引相關的一些其他詳細資訊。我們對2023 年全年和2024 年第一季合併更新的總收入指引為13 億美元，反映出產品銷售額為8.5 億美元4.5 億美元與補助金和特許權使用費有關。

Product sales includes over $700 million from committed APA dose deliveries, secured new orders and U.S. market sales of between $50 million and $150 million. The first quarter 2024 total revenue guidance of $300 million reflects the balancing amount to achieve our expected combined full year 2023 and first quarter 2024 product sales and total revenue of $1.3 billion. Of note, we previously expected no product sales in the first quarter of 2024.

產品銷售額包括超過 7 億美元的 APA 劑量交付、新訂單以及 5,000 萬至 1.5 億美元的美國市場銷售額。 2024 年第一季總營收指引為 3 億美元，反映了我們預期的 2023 年全年和 2024 年第一季產品銷售額和總收入 13 億美元的平衡額。值得注意的是，我們先前預期 2024 年第一季不會有產品銷售。

For R&D and SG&A expenses in 2023, we're on track to exceed our previously announced global restructuring cost reduction plan by over $100 million. We now expect full year 2023 R&D and SG&A expense to be approximately $1.2 billion at the midpoint and positions us well as we prepare to further improve our cost structure in 2024.

對於 2023 年的研發和銷售管理費用，我們預計將超出先前宣布的全球重組成本削減計畫超過 1 億美元。我們現在預計 2023 年全年研發和銷售、一般行政費用中位數約為 12 億美元，這使我們能夠做好準備在 2024 年進一步改善我們的成本結構。

If successful in achieving the guidance outlined today, we believe this will support the funding of our operations for the next 12 months. 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 and pending arbitration. We look forward to sharing additional updates as we seek to improve Novavax's financial performance, cost structure and strength to deliver shareholder value.

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。在我們的10-Q 備案中，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 備案中首次提供了這一信息，特別是該預測繼續受到與收入相關的重大不確定性的影響。未來 12 個月並等待仲裁。當我們尋求改善 Novavax 的財務表現、成本結構和提供股東價值的實力時，我們期待分享更多最新資訊。

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

說到這裡，我想將電話轉回給約翰，讓他做一些結束語。

Thank you, Jim. Please turn to Slide 22. I am proud of the significant progress we've made against our 3 priorities year-to-date in 2023, including the launch of our updated vaccine in the United States, being $100 million ahead of our cost reduction targets, paying down over $1 billion in current liabilities and enabling a potential Phase III initiation of our combination-vaccine program in the coming year.

謝謝你，吉姆。請參閱投影片 22。我對 2023 年迄今為止的 3 個優先事項取得的重大進展感到自豪，其中包括在美國推出更新的疫苗，比我們的成本削減目標提前了 1 億美元，償還超過10 億美元的流動負債，並有可能在明年啟動我們的組合疫苗計劃的第三階段。

We are excited about our ongoing U.S. commercial launch and the opportunities ahead as we begin to see the long-term shape of the business to come. This includes the potential for a sustainable COVID-19 business to generate annual seasonal revenue, a combination COVID-flu program to capture significant future market opportunity, and our Matrix-M adjuvant to further strengthen and diversify our revenue generation opportunities for the company in the future.

我們對正在進行的美國商業啟動以及未來的機會感到興奮，因為我們開始看到未來業務的長期形式。這包括可持續的COVID-19 業務產生年度季節性收入的潛力、捕捉未來重大市場機會的聯合COVID-流感計劃，以及我們的Matrix-M 佐劑，以進一步加強和多樣化我們在該領域為公司創造收入的機會。未來。

As I said earlier in the call, we are leaning into and focusing on our opportunity to create a robust and sustainable business platform for years to come, which includes an optimized and differentiated product presentation in 2024 and '25, as well as additional restructuring to create a more efficient business model, which will facilitate the late-stage development of and a smooth transition to the anticipated launch of our combination COVID-19-Influenza vaccine in 2026.

正如我早些時候在電話會議中所說，我們正在抓住並專注於在未來幾年創建一個強大且可持續的業務平台的機會，其中包括在2024 年和25 年進行優化和差異化的產品展示，以及對創建更有效率的商業模式，這將促進後期開發並順利過渡到預計於 2026 年推出的 COVID-19-流感聯合疫苗。

I remain confident in and grateful for our employees' dedication to advancing our objectives. We are also appreciative of the ongoing support of our loyal investors as we strive to deliver on our objectives with the intent of driving long-term shareholder value.

我對我們的員工為推進我們的目標所做的奉獻充滿信心和感激。我們也感謝忠實投資者的持續支持，因為我們努力實現我們的目標，以推動長期股東價值。

And with that, we will now take your questions.

現在我們將回答你們的問題。

(Operator Instructions) Our first question comes from Roger Song from Jefferies.

（操作員說明）我們的第一個問題來自 Jefferies 的 Roger Song。

Great. Thanks for the comprehensive update. So a couple of questions from us. Maybe start from the U.S. market. Understanding you're updating the guidance to $50 million to $150 million sales for this season. Just want you to give us a little bit kind of color how confident you are about that guidance given -- based on the third-party database seems you're still way behind that number so far. And just curious about your thinking around the season, how Novavax will capture further market share in the -- towards the end of the season.

偉大的。感謝您的全面更新。我們有幾個問題。或許可以從美國市場開始。了解您正在將本季銷售額指導值更新為 5000 萬至 1.5 億美元。只是想讓你給我們一點顏色，你對所給予的指導有多大信心——根據第三方資料庫，到目前為止，你似乎仍然遠遠落後於這個數字。只是好奇您對本賽季的想法，Novavax 將如何在本賽季結束時佔據進一步的市場份額。

And also, more importantly, how do you think about the next season and the future to come in terms of the potential market share for Novavax protein-based vaccine for COVID.

而且，更重要的是，您如何看待 Novavax 蛋白質疫苗的下一季和未來的潛在市場份額。

Roger, thank you for your question. Appreciate you joining the call. Roger, obviously, it's very early in the season right now. We're just a few weeks in with a few weeks of data before us. We've seen some very strong sparks that I'll ask John Trizzino to elucidate here for you on the call, of early interest in the vaccine. And it's still one of the biggest unknowns is how large the market will really be right? And that's something that no one's really sure about. And so, I'll ask John to comment on a few of those things. But that remains the largest uncertainty is market size in the U.S. as we go through there. John?

羅傑，謝謝你的提問。感謝您加入通話。羅傑，顯然，現在還處於賽季初期。幾週後，我們就收到了幾週的數據。我們已經看到了一些非常強烈的火花，我將請約翰·特里齊諾 (John Trizzino) 在電話會議上為您闡明這些火花，這些火花是人們對疫苗的早期興趣。最大的未知數之一仍然是市場到底有多大？這是沒有人真正確定的事情。因此，我將請約翰對其中一些事情發表評論。但最大的不確定性仍是美國的市場規模。約翰？

Thanks, John. Roger, look, I think we're learning a lot every day about this current '23, '24 season with some number of factors that we talked about during this presentation about delayed season start, the dynamics associated with multiple vaccines being in the market, the distribution challenges that have been there. And then I think we're also dealing with total market size and some growing fatigue here. So -- but related to us, I think that there's an opportunity for the balance of November and December as we look at ongoing pharmacy vaccinations.

謝謝，約翰。羅傑，聽著，我認為我們每天都在了解當前的 23、24 賽季，其中包括我們在本次演講中討論的一些因素，包括延遲賽季開始、與市場上多種疫苗相關的動態，一直存在的分銷挑戰。然後我認為我們也面臨著市場總規模和一些日益增長的疲勞。因此，但與我們相關的是，我認為當我們關注正在進行的藥房疫苗接種時，11 月和 12 月的剩餘時間是有機會的。

I think we also are going to see some significant growth in change in the non-retail sector based upon how low that, that is right now. I wouldn't expect that there would be consumer behavior, significant change of not going to the doctor's office. So I think we'll see that. And then we'll see it being a little bit elongated into Q1.

我認為，基於目前的水平，我們也將看到非零售業發生一些顯著的變化。我沒想到消費者行為會出現不去醫生辦公室的重大變化。所以我想我們會看到這一點。然後我們會看到它被稍微拉長到第一季。

As far as some of the early metrics that we're seeing, look, I think overall, we said we were seeing low single digits in some of the national -- and one in particular, national retailer, we're seeing 10% market share. This is where we're on a level-playing field. There's product in the pharmacy, and we're having good recommendation coming from the pharmacy. So we remain optimistic about the balance of the season. Obviously, that is all a controlled enthusiasm, if you will, understanding that we're kind of third to market. And we're also dealing with kind of consumer behavior where I'll just get the same vaccine that I had before. And we're beginning to see some of that shift taking place in the marketplace. So stay tuned.

就我們看到的一些早期指標而言，我認為總體而言，我們說我們看到一些全國性的低個位數——特別是全國性零售商，我們看到了 10% 的市場分享。這就是我們處於公平競爭的環境。藥局裡有產品，我們從藥局得到了很好的推薦。因此我們對本賽季的平衡保持樂觀。顯然，如果你願意的話，這都是一種受控的熱情，因為我們是市場的第三者。我們也正在處理某種消費者行為，也就是我只會接種與以前接種過的疫苗相同的疫苗。我們開始看到市場正在發生一些轉變。所以請繼續關注。

And then, Roger, the other part of your question was, confidence about next year. And I think right now, it's too early to tell. As we said, we got 3 weeks of data in our hands here. But we've seen that spark, like John mentioned, major retailer up to a 10% share. And next year, we anticipate having a better presentation, unit dose vial, BLA, a full label including pediatric data, et cetera. So right now, we're much better than we were in years before when it comes to or being on an even playing field with mRNA. But next year, we're taking the learnings from this year. It's a transition year in the U.S. and really leaning in to position ourselves very well for market penetration in 2024.

然後，羅傑，你問題的另一部分是，對明年的信心。我認為現在下結論還為時過早。正如我們所說，我們手中掌握了 3 週的數據。但我們已經看到了這種火花，就像約翰提到的那樣，主要零售商的份額高達 10%。明年，我們預計會有更好的展示、單位劑量小瓶、BLA、包括兒科數據等的完整標籤。所以現在，在 mRNA 方面或處於公平的競爭環境中，我們比幾年前要好得多。但明年，我們將吸取今年的經驗教訓。今年是美國的轉型年，我們確實有能力為 2024 年的市場滲透做好準備。

Great. And then so in terms of the ex-U.S. APA, can you let us know how likely this current $700 million in total, I think around $400 million for the remaining of the year into 1Q will be further renegotiated or are those APA already set for the delivery upon the approval? And also you already got -- just recently got approval is that start to deliver based on the order?

偉大的。就美國以外的地區而言也是如此。 APA，您能否告訴我們目前總額為 7 億美元（我認為今年第一季剩餘時間約為 4 億美元）的可能性有多大，將進一步重新談判，或者這些 APA 是否已經在批准後交付？而且您最近剛獲得批准，是否可以根據訂單開始交付？

Jim Kelly, do you want to handle that?

吉姆凱利，你想處理嗎？

Certainly. So with our APAs included in our guidance for the fourth quarter and first quarter, these are secured APAs, they're tied to committed delivery schedules. Of course, in the case of Europe, we have that approval, it's about getting the doses into market. And for important markets like Australia, New Zealand, we're in the process of completing those regulatory filings to enable us to deliver those doses. Importantly, they're Southern Hemisphere. So when those doses arrive, they're going to have the type of shelf life to be meaningful to them as they enter their season.

當然。因此，我們的預約定價安排包含在我們第四季度和第一季的指導中，這些都是安全的預約定價安排，它們與承諾的交付時間表掛鉤。當然，就歐洲而言，我們已經獲得批准，這是為了將劑量推向市場。對於澳洲、紐西蘭等重要市場，我們正在完成這些監管文件，以便我們能夠提供這些劑量。重要的是，它們位於南半球。因此，當這些劑量到達時，它們將具有對進入季節時有意義的保質期。

Now all of these APAs, they do come with stipulations that we have to deliver on time per the agreement. And if not, they can attempt to renegotiate. We currently have the expectation that we'll get them there on time per the agreement.

現在，所有這些預約定價安排都附帶了我們必須按照協議按時交付的規定。如果沒有，他們可以嘗試重新談判。目前，我們期望能夠按照協議按時將他們送達。

Maybe just one last one from me. Is the -- it's good you can directly move into the COVID-flu combination trial -- Phase III trial, next year. Given the additional operational expense cut for 2024, how do you think that will impact the Phase III plan? And will you be able to sufficiently fund that trial without a partner?

也許只是我的最後一張。明年可以直接進入新冠流感聯合試驗第三期試驗，這很好。鑑於 2024 年額外削減營運費用，您認為這將如何影響第三階段計畫？如果沒有合作夥伴，您是否能夠為該試驗提供足夠的資金？

Good question, Roger. Go ahead, Jim.

好問題，羅傑。繼續吧，吉姆。

Great question. And -- I'll first reference back what is, I think, a pretty exciting update from Filip today about a very lean approach in path -- an potentially accelerated path to get our combination product to the market as early as 2026 with a single pivotal study. I mean this is an important game changer. I think many folks heard something very similar from Moderna recently. And we think it enables us a path to market in a highly capital, I'll call it, efficient manner.

很好的問題。而且 - 我將首先回顧 Filip 今天關於一種非常精益的方法的非常令人興奮的更新 - 一條可能加速的路徑，使我們的組合產品最早在 2026 年進入市場關鍵研究。我的意思是這是一個重要的遊戲規則改變者。我想很多人最近都從 Moderna 聽到了非常類似的事情。我們認為它使我們能夠以高資本（我稱之為高效率）的方式進入市場。

Okay. So with respect to the update we provided today, where we are going to drive our R&D and SG&A to below $750 million next year. That is inclusive of beginning this study next fall. And so we have contemplated that, that we are both focused on creating not just a competitive COVID product, but also accelerating our combination product, while establishing a lean and focused organization to do so.

好的。因此，就我們今天提供的更新而言，我們明年將把研發和銷售、一般管理費用 (SG&A) 推至 7.5 億美元以下。這包括明年秋天開始這項研究。因此，我們考慮到，我們不僅專注於創造有競爭力的新冠產品，而且還要加速我們的組合產品，同時建立一個精幹且專注的組織來實現這一目標。

And if you wouldn't mind, I'll talk a little bit about the cash runway that enables that. I described to you 3 really important components. And I'm going to describe these components before factoring in the U.S. market opportunity, which I think John did a really nice job highlighting. We can see a path through the end of 2025 to over $2 billion in cash through 3 critical pieces I described as of today, over $960 million in cash and expected cash on -- combining cash on hand, accounts receivable, plus that $175 million expected contingent payment from Canada.

如果您不介意的話，我將談談實現這一目標的現金跑道。我向您描述了 3 個非常重要的組成部分。在考慮美國市場機會之前，我將先描述這些組成部分，我認為約翰在強調這一點方面做得非常好。我們可以看到，到2025 年底，透過我今天描述的3 個關鍵部分，現金將超過20 億美元，現金和預期現金將超過9.6 億美元——手頭現金、應收帳款，加上預計的1.75億美元來自加拿大的或有付款。

Add to that, the $600 million at midpoint of current season '23, '24 sales in the fourth quarter and first quarter of next year. And then we described over $750 million outstanding APA contract value for '24 and '25. Now you net out some of the upfronts and you've got clear visibility of over 200 -- or excuse me, $2 billion in cash. Then as you seek to execute against that, lean and focused organization, reducing our cost structure to ensure we are prepared with financial strength for both next fall and to accelerate and invest in that combination program. So hopefully, that's helpful.

除此之外，本季 23、24 年第四季和明年第一季的銷售額為 6 億美元。然後我們描述了 24 年和 25 年未完成的 APA 合約價值超過 7.5 億美元。現在你扣除一些預付款，你就可以清楚地看到超過 200 美元——或者對不起，20 億美元的現金。然後，當您尋求執行精益和專注的組織時，降低我們的成本結構，以確保我們為明年秋天做好財務實力準備，並加速和投資該組合計劃。希望這會有所幫助。

And Jim and Roger, also that doesn't include what Jim just laid out, that over $2 billion runway over the next 24 months does not contemplate anything else from U.S., from Europe, from other markets like South Korea, which just placed a new order with us for our R21 vaccine, which just received 2 authorization or from things like UNICEF in low-income countries, all additional opportunities for the company to generate revenue in the coming years and even in the coming quarters potentially. So what Jim laid out is just what's primarily secured revenues, already contemplated through APAs.

吉姆和羅傑，這也不包括吉姆剛剛提出的，未來 24 個月內超過 20 億美元的跑道不會考慮來自美國、歐洲、韓國等其他市場的任何其他東西，韓國剛剛放置了一個新的向我們訂購R21 疫苗，該疫苗剛剛獲得2 項授權，或從低收入國家的聯合國兒童基金會等機構訂購，所有這些都為該公司在未來幾年甚至未來幾個季度創造收入提供了額外的機會。因此，吉姆提出的主要是透過預約定價安排已經考慮到的收入保障。

One other point is on the $600 million Jim talked about between Q4 and Q1. The vast majority of that is secured revenue through APAs, which we intend to deliver the full doses for and the minority of that is the first-year launch in the United States. So just to give you the opportunity we have before us from a revenue standpoint, a cash standpoint to carry us independently forward to our CIC program launch and then the upside potential beyond for all of those other [pieces].

另一點是吉姆在第四季和第一季之間談到的 6 億美元。其中絕大多數是透過 APA 獲得的收入，我們打算為其提供全部劑量，其中少數是在美國第一年推出的。因此，從收入的角度和現金的角度來看，我們只是為了給您提供機會，讓我們能夠獨立推進 CIC 計劃的啟動，以及所有其他[部分]的上行潛力。

Our next question comes from Eric Joseph of JPMorgan.

我們的下一個問題來自摩根大通的埃里克約瑟夫。

In the U.S., looking across the pharmacies that you contracted with to carry the updated vaccine, can you just -- well, how should we be thinking about their aggregate market share as it relates to seasonal vaccines, perhaps prior COVID seasons, flu seasons. Really getting at the question of how much a ceiling, Walgreens not being a part of the mix, not being a carrier, represents for your product uptake? And I guess, should we see perhaps Walgreens revisiting that decision over the season?

在美國，看看與您簽約攜帶更新疫苗的藥房，我們應該如何考慮它們的整體市場份額，因為它與季節性疫苗有關，也許是之前的新冠肺炎季節、流感季節。真正要解決的問題是，沃爾格林不是混合產品的一部分，也不是承運商，這代表了您的產品吸收率有多少上限？我想，我們是否應該看到沃爾格林在整個賽季中重新考慮這項決定？

All right, Eric, I'll ask John T to comment. First, John, maybe on channel share and then the dynamic with Walgreens.

好吧，埃里克，我會請約翰·T ​​發表評論。首先，約翰，也許是關於頻道共享，然後是與沃爾格林的動態。

So I think you're talking about what is historical channel mix and then what is it looking like so far this year. So I made reference to some of that in the presentation where for flu, what we're seeing this year is about 65% in retail and 35% in non-retail that's approximately accurate for the last 5, 6-plus years or so. And typically, for a seasonal vaccine -- for COVID last year, similar statistics and there was about 60%, 70% in retail and the balance in non-retail. We're just not seeing that at the moment. We're seeing sub, let's call it, a few hundred thousand doses in the non-retail channel based upon the IQVIA data that we're seeing so far. So we expect to see that change a bit in market mix.

所以我認為你正在談論什麼是歷史頻道組合以及今年到目前為止的情況。因此，我在演示中提到了其中的一些內容，對於流感，我們今年看到零售業佔 65%，非零售業佔 35%，這在過去 5、6 年左右的時間裡大致是準確的。通常情況下，對於季節性疫苗——去年的新冠肺炎，類似的統計數據大約有 60%、70% 是零售的，其餘的是非零售的。我們只是目前還沒有看到這一點。根據我們迄今為止所看到的 IQVIA 數據，我們在非零售通路中看到了數十萬劑次劑量。因此，我們預期市場結構會發生一些變化。

Consumer behaviors and actions don't change dramatically in that sort of period of time. But we're monitoring that to see if that's true. But so far, it's heavy, heavy retail sector and not yet seeing that shift. What we're also seeing is a season that's elongating typically for flu, you'd see 50% of the volume before the end of October. Again, we're not seeing that for COVID, and we saw that for COVID last year. So there's a push for multiple reasons. I think there's a heavy burden on pharmacy vaccinations that is affecting all that. And so we're monitoring it closely. As we said earlier on in the presentation, we're only 3 weeks into data that we're seeing. And so more to come over the next few weeks as we monitor that mix in the market.

在這段時間內，消費者的行為和行動不會有巨大變化。但我們正在監控這種情況，看看這是否屬實。但到目前為止，零售業的規模非常龐大，但尚未看到這種轉變。我們也看到流感季節通常會延長，在 10 月底之前您會看到流感數量的 50%。再說一次，我們沒有看到新冠病毒的情況，去年我們看到了新冠病毒的情況。因此，有多種原因推動。我認為藥房疫苗接種的沉重負擔正在影響這一切。所以我們正在密切監視它。正如我們之前在演示中所說，我們僅在三週內就看到了數據。因此，在接下來的幾週內，當我們監測市場的這種組合時，還會有更多的事情發生。

And Eric, I believe the other part of your question was specific to Walgreens for John. And so we're in over 14,000 retail outlets in the United States right now with broad distribution and also working with the IDNs to make sure if physician network or other channels want the vaccine. It's readily accessible to them, including our participation in the U.S. government Bridge Program. But John, you may want to just put into context the Walgreens piece. That was Eric's specific question there, I believe.

艾瑞克，我相信你問題的另一部分是專門針對約翰的沃爾格林的。因此，我們目前在美國 14,000 多個零售店進行廣泛分銷，並與 IDN 合作，以確保醫生網路或其他管道是否需要疫苗。他們很容易獲得這些信息，包括我們參與美國政府的橋樑計劃。但是約翰，你可能只想將沃爾格林的文章放在上下文中。我相信這是埃里克的具體問題。

Yes, so (technical difficulty). Hello, operator?

是的，所以（技術難度）。你好，接線生？

We can hear you.

我們能聽到你的聲音。

And it's important to understand that we're seeing that through that retail locations for all of the retailers, a great relationship with CVS. I think they're seeing a lot of vaccines coming through their locations. We're talking about programs to evolve that communication into the pharmacy to make sure that there's awareness looking at all -- any and all other opportunities to create awareness for the consumer as well as awareness for the health care provider and mentioning that earlier that, that awareness and acknowledgment is up over the last couple of months, and we expect to see that trend continue.

重要的是要了解，我們透過所有零售商的零售地點看到與 CVS 建立了良好的關係。我認為他們看到很多疫苗從他們的所在地運來。我們正在討論將這種溝通發展到藥房的計劃，以確保人們有意識——任何和所有其他機會來提高消費者的意識以及醫療保健提供者的意識，並且之前提到過，在過去的幾個月裡，這種意識和認可度有所提高，我們預期這種趨勢將會持續下去。

Eric, I'll just add -- thank you, John. I'll just build one point on top of what John so clearly stated there, which is that based on CVS alone, you have roughly 75% of all Americans are within 5 miles of 1 of their retail outlets. So the vast majority of Americans are very close if they want our vaccine, they can get our vaccine. That was the goal. Would we like to have Walgreens? Absolutely. We continue to work with them. They're a good partner and will be for the long run. But despite that, we're close to most Americans. And if they want our vaccine, they have access to it, that's the important thing.

艾瑞克，我要補充一點──謝謝你，約翰。我將在約翰明確指出的基礎上提出一點，即僅根據 CVS，大約 75% 的美國人都在其零售店 1 的 5 英里範圍內。因此，絕大多數美國人非常接近，如果他們想要我們的疫苗，他們就能得到我們的疫苗。這就是目標。我們想要沃爾格林嗎？絕對地。我們繼續與他們合作。他們是很好的合作夥伴，而且會是長期的合作夥伴。但儘管如此，我們與大多數美國人還是很接近的。如果他們想要我們的疫苗，他們就可以獲得它，這才是重要的事情。

Maybe just I can ask one follow-up for Jim, just thinking about sort of how the OpEx efficiencies perhaps should be recognized over the course of 2024? And maybe it's too early for this, but just been thinking about sort of the longer-term outlook, how -- whether we should anticipate sort of resumption of -- or build of OpEx in '25, particularly as you think about obviously self-funding the CIC Phase III trial.

也許我可以問 Jim 一個後續問題，只是想一下在 2024 年期間應該如何認識營運支出效率？也許現在對此還為時過早，但只是在考慮某種長期前景，我們是否應該預期在 25 年恢復或建立營運支出，特別是當你考慮明顯的自我時資助 CIC III 期試驗。

I'm going to begin this with what I'll call a profile of profitability that we're driving to. When we think about a long-term, sustainable, profitable organization, we're looking to what I'll call at least 50% commercial contribution margins. And what I mean by that is sales minus COGS, minus SG&A, all right? And then, of course, you reinvest in R&D under that. And in doing so, you really got to get your gross margins in sort of sales minus COGS in that 70% to 80% range. So start with that as, hey, what's your blueprint to drive this company to be an efficient and capital or a cash producing entity? That's the vision.

我將從我們所追求的獲利能力概況開始。當我們考慮一個長期、可持續、盈利的組織時，我們期待的是我所說的至少 50% 的商業邊際貢獻。我的意思是銷售額減去銷貨成本，減去銷售及管理費用，好嗎？然後，當然，你會在研發上再投資。在這樣做的過程中，你確實必須得到 70% 到 80% 範圍內的銷售額減去銷貨成本的毛利率。因此，首先，嘿，您推動這家公司成為高效資本或現金生產實體的藍圖是什麼？這就是願景。

And then as we look at the evolution of that through '24 and '25, while we are describing an urgency to evaluate and act and drive to this cost structure, we're not today announcing, for example, a specific restructuring. We're previewing it for you. but you witnessed us earlier this year act with speed. And so you should expect that we will do so that we can recognize as much of those savings as early as possible to fully drive towards that $750 million or less in R&D and SG&A for 2024, while continuing to accelerate the CIC program and driving to a filing in 2025 that in turn could enable a launch as early as 2026. So those are the, I'll call it, the blueprint, the guiding principles for where we're headed.

然後，當我們審視「24」和「25」期間的演變時，雖然我們描述了評估、採取行動並推動這種成本結構的緊迫性，但我們今天並沒有宣布例如具體的重組。我們正在為您預覽。但今年早些時候您親眼目睹了我們的快速行動。因此，您應該期望我們這樣做，以便我們能夠儘早認識到盡可能多的節省，以充分推動 2024 年研發和銷售及管理費用達到 7.5 億美元或更少，同時繼續加快 CIC 計劃並推動實現2025 年提交申請，最早可以在2026 年啟動。所以這些就是我們前進方向的藍圖和指導原則。

Our next question comes from Brendan Smith from TD Cowen.

我們的下一個問題來自 TD Cowen 的 Brendan Smith。

Just a couple of quick ones from us. First, I wanted to clarify something, I think I might have heard for the ex-U.S. approvals, are you still in the process of completing some of these filings? Or are they all done and you're just waiting on actual approval? And can you maybe provide any additional color you have on the potential timing or cadence for the remaining ex-U.S. approvals kind of just based on your conversations there? It's kind of really related to Roger's earlier question, trying to understand just the possibility that any of those might get pushed a little past Q1, just kind of based on the cadence.

我們僅提供一些快速的資訊。首先，我想澄清一些事情，我想我可能聽說過前美國的情況。批准，您仍在完成其中一些文件嗎？或者它們都已經完成了，您只是在等待實際批准？您能否提供有關剩餘美國以外地區的潛在時間或節奏的任何其他資訊？批准只是基於你們在那裡的對話？這與羅傑之前的問題確實相關，試圖理解其中任何一個可能會被推到第一季之後的可能性，只是基於節奏。

And then related to that, can you kind of tell us how you're thinking about that $300 million in Q1? Have any of the Q4 APAs renegotiated at all? Or have you actually confirmed delivery in Q1 with some of these territories? Or is this kind of just a best guess based on the current trajectory of how things are going? And then I have a follow-up.

與此相關，您能否告訴我們您如何看待第一季的 3 億美元？第四季 APA 是否已重新談判？或者您實際上已經確認在第一季向其中一些地區發貨嗎？或者這只是基於當前事情發展軌蹟的最佳猜測？然後我有一個後續行動。

John Trizzino, why don't you take that first question, then we'll hear the follow-up.

約翰·特里齊諾（John Trizzino），你為什麼不回答第一個問題，然後我們會聽到後續問題。

So ex-U.S. approvals, we are still waiting on several, we have U.S. and EMA at this point. We're waiting on U.K., Canada, Australia and New Zealand, Singapore, Taiwan, and also have expectation for WHO regions to be received within the next few weeks. And certainly, that will allow us to make those deliveries, many of them before, the end of the year and the possibility that some of that timing might roll over into Q1 as we've provided some guidance for -- in that [cut].

所以前美國批准，我們仍在等待幾個批准，目前我們已經獲得了美國和 EMA 的批准。我們正在等待英國、加拿大、澳洲和紐西蘭、新加坡、台灣，並期望在未來幾週內收到世衛組織地區的訊息。當然，這將使我們能夠進行交付，其中許多是在今年年底之前完成的，並且其中一些時間可能會延續到第一季度，因為我們已經提供了一些指導 - 在[剪切]中。

I'll leave the explanation of the $300 million in Q1 to Jim.

我將第一季 3 億美元的解釋留給吉姆。

Yes, go ahead, Jim.

是的，繼續吧，吉姆。

Yes, certainly. As John mentioned, we've got secured orders for delivery. If you look at the midpoint of our guidance, you are going to see that we've got APAs within that guidance that are approximately $500 million, so call it sort of $475 million to $525 million, spread across the fourth quarter and the first quarter. And with that said, the way things are moving with our supply chain, we've got inventory ready to go. It's really about lining up those deliveries. And with some of them, like the European deliveries, there could be some -- it could end up hitting in the fourth quarter, in total, but we just don't want to overpromise...

是的，當然了。正如約翰所提到的，我們已經收到了交付訂單。如果您查看我們指導的中點，您會發現我們在該指導中的預約定價安排約為 5 億美元，因此可以稱之為 4.75 億至 5.25 億美元，分佈在第四季度和第一季。話雖如此，按照我們供應鏈的發展方式，我們已經準備好了庫存。這實際上是為了排列這些交付。其中一些，例如歐洲的交付，可能會有一些——總共可能會在第四季度達到預期，但我們只是不想過度承諾...

The bottom line is we don't expect any of this to drift beyond Q1, right? Jim, anything to add to that?

最重要的是，我們預計這一切都不會超出第一季度，對吧？吉姆，還有什麼要補充的嗎？

No, that's it.

不，就是這樣。

And then just on the cost cuts, can you maybe expand a bit on maybe where some of the new R&D cuts will be coming from, how they're distributed across 2024? And maybe whether these are being accounted for elsewhere in your filings. Just kind of trying to get a little bit of a sense beyond the plan really what they'll look like and potentially if there's been any tangible changes in like accounting methods over the past few or upcoming quarters?

然後就成本削減而言，您能否詳細說明一些新的研發削減將來自何處以及它們在 2024 年如何分配？也許這些是否已在您的文件中的其他地方解釋。只是想稍微了解一下計劃之外的實際情況，以及過去幾個季度或未來幾個季度會計方法是否可能發生任何切實的變化？

So we shared with you that we're going to be reducing our R&D and SG&A by over $200 million and also reducing our supply chain-related expenses by over $100 million for a total of over $300 million in savings. Where did these come from? I should first say, this is not a function, I would say, of forward-looking accounting. It is not. This is about real savings, real cash, real improvement to our cost structure. Where these come from? It's a focused evaluation that begins with the markets we serve and the return on that investment as we pursue the COVID opportunity and prepare for the combination opportunities. So start with focused investment, then you assess your people, your sites, facilities, capabilities, capital investments to support that. You then evaluate third-party vendors and what it takes to have them along assisting us on that journey and you resize and reshape all of it.

因此，我們與您分享，我們將減少 2 億多美元的研發和銷售管理費用，並將供應鏈相關費用減少 1 億多美元，總共節省 3 億多美元。這些是從哪裡來的？我首先要說的是，我想說，這不是前瞻性會計的功能。它不是。這是關於真正的節省、真正的現金、真正改善我們的成本結構。這些從哪裡來？這是一項重點評估，從我們服務的市場以及我們在尋求新冠機會並為合併機會做準備時的投資回報開始。因此，從集中投資開始，然後評估您的人員、場地、設施、能力和資本投資來支持這一目標。然後，您評估第三方供應商以及如何讓他們在這過程中協助我們，並調整和重塑所有這些。

So I'll give you specific examples of thinking along supply chain. One, we got to better manage the alignment of supply with demand. We got to avoid these write-offs, this E&O. This has to do with how much we do at risk as we further sharpen our focus on the demand signal, we've got to knock that out. Then you look at your internal operations and based on that, you got to be leaner. I'm talking about facilities, reduced idle capacity and any overhead support. And then we got to continue to negotiate aggressively third-party agreements relating to our supply network. So that's how you come after your supply side.

因此，我將為您提供沿著供應鏈思考的具體範例。第一，我們必須更好地管理供應與需求的一致性。我們必須避免這些沖銷、E&O。這與我們在進一步加強對需求訊號的關注時所面臨的風險程度有關，我們必須消除這種風險。然後你看看你的內部運營，並在此基礎上，你必須變得更加精簡。我說的是設施、減少的閒置產能和任何間接費用支援。然後我們必須繼續積極談判與我們的供應網絡相關的第三方協議。這就是你追求供應方的方式。

On the R&D side, you heard from Filip, a lean focused approach with CIC. That's how you do it. You get to market faster with CIC and a more efficient investment profile. And then everything I said about commercial market and infrastructure and overhead, we're going to drive for higher efficiencies to support this leaner-focused company.

在研發方面，您聽到了 Filip 的說法，他與 CIC 合作採用了精實專注的方法。你就是這樣做的。透過 CIC 和更有效率的投資組合，您可以更快進入市場。然後，我所說的有關商業市場、基礎設施和管理費用的一切，我們將努力提高效率，以支持這家專注於精簡的公司。

And Jim, just to build upon that, thank you for that clarity. The company was originally scaled and built for a much larger opportunity in a global pandemic. And we demonstrated earlier this year with decisive action as a leadership team, management team and Board that we can make the right decisions to scale down that business. And in fact, we're proud of the fact that this year, we're over $100 million ahead on the 2023 cost reduction targets that we announced earlier in the year, and we did so without damaging our capabilities to operate, that's really key.

吉姆，在此基礎上，感謝您的澄清。該公司最初的規模和建立是為了在全球大流行中獲得更大的機會。今年早些時候，我們作為領導團隊、管理團隊和董事會採取了果斷行動，證明我們可以做出正確的決定來縮小業務規模。事實上，我們感到自豪的是，今年我們比今年稍早宣布的 2023 年成本削減目標提前了 1 億多美元，而且我們這樣做並沒有損害我們的營運能力，這非常關鍵。

And now as a new team here, a management team, since I joined in the beginning of the year, we've had a line of sight on strain selection to shots-in-arms cycle this year and an assessment of how the COVID market is unveiling itself post pandemic. And with that line of sight and the knowledge of the capabilities we need to continue to operate efficiently and bring forward our program, we're confident we can make the real cuts, as Jim said, not by accounting function, but by reducing scope and scale and taking expense out of the system to make this company leaner and more focused and more competitive and able to independently bring forward that CIC program to a filing status.

現在，作為這裡的一個新團隊，一個管理團隊，自從我今年年初加入以來，我們已經對今年的菌株選擇和射擊週期有了一定的了解，並對新冠病毒市場的情況進行了評估正在大流行後揭開面紗。有了這樣的視野和對我們繼續有效運作並推進我們的計劃所需的能力的了解，我們有信心我們能夠實現真正的削減，正如吉姆所說，不是通​​過會計職能，而是通過縮小範圍和擴大規模並減少系統費用，使該公司更精簡、更專注、更具競爭力，並能夠獨立地將CIC 計劃提交至備案狀態。

Jim, anything to add to that?

吉姆，還有什麼要補充的嗎？

It's that focused -- the way we're operating day-in and day-out, we're laser focused on driving towards everything you just said, John.

正是這種專注——我們日復一日的運作方式，我們全神貫注地致力於實現你剛才所說的一切，約翰。

(Operator Instructions) And our next question comes from Mayank Mamtani of B. Riley Securities.

（操作員指示）我們的下一個問題來自 B. Riley Securities 的 Mayank Mamtani。

So maybe just a follow-up to a prior comment on cost of goods expectations for 4Q, 1Q. Any early insight on sort of the returns expected? Retail, nonretail segments. I know you're trying to manage this as real time as possible. And I also noticed your grant revenue was particularly high today, and there were some write-offs, I guess. Could you just clarify, what's sort of going on in that line item?

因此，也許只是先前對第四季、第一季商品成本預期評論的後續。對預期回報有什麼早期見解嗎？零售、非零售領域。我知道您正在嘗試盡可能即時地管理它。我還注意到你們今天的贈款收入特別高，我猜還有一些沖銷。您能否澄清一下該行項目中發生了什麼事？

There's 3 particular pieces you hit there. One is, hey, what are we learning about returns? A second one has to do with grant revenue and what are we seeing there. And forgive me, Mayank, what's the third one?

您擊中了 3 個特定的棋子。一是，嘿，我們對回報了解了什麼？第二個問題與贈款收入以及我們在那裡看到的情況有關。請原諒我，Mayank，第三個是什麼？

Yes, the cost of sales line item today that you just reported for 3Q, yes.

是的，您剛剛報告的第三季的今天銷售訂單項目的成本，是的。

Yes, you got it. So beginning with returns, hey, our return window really opened the first of November. So too early to tell. What we're pleased with is, hey, we had really good, I'll call it, specialty distribution uptick and also sell-through to ensure we've got our vaccine across the country available. But too early to give feedback on returns, we're going to be monitoring that one very closely, of course.

是的，你明白了。所以從退貨開始，嘿，我們的退貨窗口確實在 11 月 1 日開放。所以現在說還太早。我們感到滿意的是，嘿，我們確實做得很好，我稱之為專業分銷上升和銷售，以確保我們在全國範圍內獲得疫苗。但現在就回報提供回饋還為時過早，當然，我們將非常密切地監控這種情況。

On grant revenue, you are seeing across both grants and royalties that we're upticking our guidance by $100 million. Why? Filip has done an exceptional job working with our partners in the U.S. government to do -- enable us to take full advantage of that $1.8 billion (inaudible) revenue. And in addition to that, there were multiple milestones tied to our success in being prepared for the U.S. market, we met them. and that's why you're seeing improvements there.

在贈款收入方面，您會發現我們將贈款和特許權使用費的指導價值上調了 1 億美元。為什麼？ Filip 與我們在美國政府的合作夥伴一起做了出色的工作，使我們能夠充分利用這 18 億美元（聽不清楚）的收入。除此之外，我們在為美國市場做好準備方面取得了成功，也實現了多個里程碑，我們滿足了這些里程碑。這就是為什麼你會看到那裡的改進。

In addition, about $12 million this quarter, Matrix R21 revenue related to the malaria R21 vaccine as our partner, Serum is preparing to launch as early as next year. So really important advancement there.

此外，Matrix R21本季約1,200萬美元的收入與我們的合作夥伴Serum的瘧疾R21疫苗相關，Serum正準備最早於明年推出。所以這方面的進步非常重要。

Okay. Let's talk a little bit about the COGS line. what you're noting is that we had COGS in a quarter where we had no revenue, we had COGS of $99 million. All right. Let's talk about what's happened in there. There's a benefit from the SK Bio settlement of $22 million. I think you know that. So that would take it up to about $121 million. What is in that? You've got $85 million or $82 million in excess capacity. We noted that, add to that some scrap and overhead. What I mentioned to you is, hey, we got to be better. We can't have that happen. We got to be more focused on that front. And then finally, some unabsorbed overhead, about $20 million. Again, this is a part of being lean and focused. These are the types of things we're seeking to drive down. Hopefully, that helps you.

好的。我們來談談 COGS 線。您注意到的是，在沒有收入的季度中，我們的銷貨成本為 9,900 萬美元。好的。我們來談談裡面發生的事吧。 SK Bio 和解協議帶來 2,200 萬美元的收益。我想你知道這一點。因此，這將使其達到約 1.21 億美元。那裡面是什麼？你有 8500 萬美元或 8200 萬美元的過剩產能。我們注意到，再加上一些廢料和管理費用。我向你提到的是，嘿，我們必須做得更好。我們不能讓這種事發生。我們必須更加關注這方面。最後還有一些未吸收的管理費用，約 2000 萬美元。再說一遍，這是精益和專注的一部分。這些都是我們想要減少的事情。希望這對您有幫助。

Yes. Super helpful, very comprehensive. And then maybe just picking on that regulatory milestones that I think was noted also in your Q, including for under 18-year-old, maybe for higher dose that you're looking at for the elderly. Could you just, Filip, update on what all -- is going on there for the updated 2023, '24 vaccine.

是的。超級有幫助，非常全面。然後也許只是選擇我認為在您的問題中也提到的監管里程碑，包括針對 18 歲以下的兒童，也許您正在為老年人尋找更高的劑量。 Filip，您能否更新一下 2023 年 24 年更新疫苗的進展。

And then also a similar road map for the CIC program, what sort of dose optimization work remains? And also, if you anticipate any ex-U.S. regulatory guidance to also come along with all the discussions we're having with the FDA.

然後還有類似的 CIC 計畫路線圖，還需要哪些劑量優化工作？而且，如果您預計任何前美國監管指南也將與我們與 FDA 進行的所有討論一起出現。

Mayank, why don't we ask Filip to address some of your questions on the clinical programs and the related regulatory milestones there. Filip?

Mayank，我們為什麼不請 Filip 回答您有關臨床項目和相關監管里程碑的一些問題。菲利普？

You managed to squeeze a lot into that one run-on sentence, Mayank. So we laid out the regulatory timings for CIC in the U.S. We think that's going to be the most important market for us, right? It's a product that we see demand from consumers as well as from health care providers, and that's our focus. The timelines we laid out was a potential regulatory filing in 2025, with a potential accelerated approval or in the market in '26.

Mayank，你成功地將很多內容塞進了這一個連續的句子。因此，我們為 CIC 在美國制定了監管時間表。我們認為這將是我們最重要的市場，對吧？我們看到消費者和醫療保健提供者對這種產品有需求，這就是我們的重點。我們制定的時間表可能是在 2025 年提交監管文件，可能會加速批准或在 26 年上市。

Now as far as the high dose product. That's a program that was supported by U.S. government. We've finished enrolling that study or we will today. So the timelines of that aren't going to be available until the following year. Pediatric data, we previously said that we would be filing the -- or we would have data available in the first quarter of next year. And we think that older age group will be relevant for the following season.

現在就高劑量產品而言。這是一個得到美國政府支持的計劃。我們已經完成了該研究的註冊，或者今天就會完成。因此，時間表要到明年才能公佈。兒科數據，我們之前說過我們將提交 - 或者我們將在明年第一季提供數據。我們認為年齡較大的群體將與下個賽季相關。

I think we have time for one or 2 more questions here.

我想我們還有時間再問一兩個問題。

And our next question comes from Alec Stranahan of Bank of America.

我們的下一個問題來自美國銀行的亞歷克·斯特拉納漢。

A couple from us as well. The first is on the multi-dose format. Given the demand kinetic you've seen to date, do you see a risk of some doses in a vial not being used? And what happens to those doses? Are they shipped back to you guys? And how does that feed into the price or reimbursement to pharmacies? And then I've got a follow-up.

我們還有一對夫婦。第一個是多劑量形式。鑑於您迄今為止所看到的需求動態，您是否認為小瓶中的某些劑量有未被使用的風險？這些劑量會發生什麼事？都運回來給你們了嗎？這如何影響藥房的價格或報銷？然後我有一個後續行動。

I will have John Trizzino address that one on returns.

我會讓約翰·特里齊諾（John Trizzino）在退貨時發表講話。

Alex (sic) [Alec] look, we're in a 5-dose vial. And I think, of course, I would anticipate it for our future, we be in some kind of unit dose presentation and that's what the marketplace wants and we're moving in that direction.

Alex（原文如此）[Alec] 看，我們裝的是 5 個劑量的小瓶子。我認為，當然，我會預期我們的未來，我們會進行某種單位劑量的演示，這就是市場想要的，我們正在朝這個方向前進。

As far as the use of those vials, we've again made sure that there's flexibility to the health care provider in the use of that vial. So if not all 5 doses are used, there's an opportunity to return partial vials and we're tracking that through a third-party provider of that returns process.

就這些小瓶的使用而言，我們再次確保醫療保健提供者在使用該小瓶時具有靈活性。因此，如果未使用全部 5 劑劑量，則有機會退回部分小瓶，我們正在透過退貨流程的第三方提供者進行追蹤。

So it's been made -- clearly communicated that our intent is to provide access, getting product on the shelf and available that then is utilization of whatever is available in that period of time. And that there is a returns provision in place that allows for that with no cost and economic disadvantage to the health care provider. And then we monitor that on our end.

因此，我們已經清楚地傳達了這樣的訊息：我們的目的是提供存取權限，讓產品上架並可用，然後利用該時間段內可用的任何東西。並且有一項退貨條款，可以在不增加醫療保健提供者成本和經濟損失的情況下實現這一點。然後我們監控這一點。

And then a quick comment on rev rec. I mean pharma products, highly common to have a return provision. So this is far from uncharted territory. We'll have the regular gross and net entry, and we'll make an estimate. We've got visibility on our return rate as we seek to close the books for the fourth quarter based on both actual returns come in and then visibility through the channel. So this will be an important part of our revenue recognition go forward.

然後對revrec進行快速評論。我指的是醫藥產品，通常有退貨條款。所以這遠非未知領域。我們將定期獲得總收入和淨收入，並進行估算。當我們尋求根據實際回報以及透過管道的可見性結清第四季度的帳簿時，我們已經了解了我們的回報率。因此，這將是我們未來收入確認的重要組成部分。

And Alec, you said you had another question.

亞歷克，你說你還有另一個問題。

Yes, just a quick one. I noticed some new language in the queue around the -- withholding the installment payment to Fujifilm. Is this due to a breach of contract or something else? Are there other vendors that you may seek to withhold payments to for similar reasons? And just high level, how you see the arbitration playing out?

是的，只是快一點。我注意到隊列中出現了一些新的語言——扣留向富士膠片的分期付款。這是由於違反合約還是其他原因？是否有其他供應商可能因類似原因而尋求扣留付款？高層，您如何看待仲裁的結果？

Jim Kelly, do you want to take that one?

吉姆凱利，你想買那個嗎？

Absolutely. Alec, you're exactly right. We have disclosed that -- with respect to the remaining 2 payments that were targeted for the third and fourth quarter, that $68 million total that we are currently in a dispute or difference of opinion with Fuji at this time, it's a legal matter. So I can't speak too much about it. You might remember that those payments were each subject to commercially reasonable effort to mitigate our exposure. And I think that's all I can say at this time.

絕對地。亞歷克，你說得完全正確。我們已經透露，對於第三季和第四季剩餘的兩筆付款，即我們目前與富士存在爭議或意見分歧的總計 6,800 萬美元，這是一個法律問題。所以我不能對此說太多。您可能還記得，這些付款都經過商業上合理的努力，以減輕我們的風險。我想這就是我現在能說的。

And time for one more question.

是時候再問一個問題了。

And our last question comes from Vernon Bernardino, a private investor (sic) [from H.C. Wainwright].

我們的最後一個問題來自私人投資者 Vernon Bernardino（原文如此）[來自 H.C.溫賴特]。

I am from H.C. Wainwright. Can you comment on what regulatory concurrence is being discussed for a final clinical study design for the combination vaccine? And I'll just throw the follow-up now. For the '24, '25 season, can you give us your thoughts on what dynamics you expect regarding authorization of your uptake in vaccine, and it's roll out for that season?

我來自 H.C.溫賴特。您能否評論一下聯合疫苗的最終臨床研究設計正在討論哪些監管共識？我現在就進行後續跟進。對於「24」、「25」季節，您能否告訴我們您對疫苗接種授權以及該季節推出疫苗的預期動態有何看法？

Filip, do you want to take the first part of Vernon's question?

菲利普，你想回答佛農問題的第一部分嗎？

Sure. So the major focus with us is going to be with the FDA, and this is really going to be part of a pre-IND discussion with them. Since we're filing an IND in the U.S. to support the U.S. study. That's an interaction that we have planned for the first quarter. We are going into that with a lot of data to bring to them, and that's why the timing is in the first quarter of '24.

當然。因此，我們的主要關注點將是 FDA，這實際上將成為與他們進行 IND 前討論的一部分。由於我們正在美國提交 IND 來支持美國的研究。這是我們計劃在第一季進行的互動。我們正在研究這個問題，並向他們提供大量數據，這就是為什麼時間安排在 24 年第一季。

So let me follow up on that next question, Vernon, on plans for '24, '25. We're intending to have an updated profile for the vaccine that's being offered. We're looking at a unit dose presentation available on a more timely basis than we were able to this year, so earlier in the season availability. And then, of course, it's our reasonable expectation that we would be under BLA for the '24, '25 season as well. So I think those are significant factors that are driving an improved uptake in market share and presentation to the marketplace.

弗農，讓我繼續回答下一個問題，關於 24 年和 25 年的計劃。我們打算更新所提供疫苗的資料。我們正在考慮比今年更及時地提供單位劑量演示，因此在季節中更早提供。當然，我們合理地期望我們在 24、25 賽季也會受到 BLA 的約束。因此，我認為這些是推動提高市場佔有率和市場展示的重要因素。

And operator, I believe we're at time, at this point.

接線員，我相信我們現在就在這個時間點上。

And 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。我想將會議轉回約翰做總結發言。

I want to thank everyone for their time and energy and for your questions and wish you a great close to your week. Appreciate you all. Thank you.

我要感謝大家付出的時間和精力以及提出的問題，並祝福你們有個愉快的一週。感謝你們大家。謝謝。

The meeting has now concluded. Thank you for joining and have a pleasant day.

會議現已結束。感謝您的加入並祝您有個愉快的一天。