莫德納 (MRNA) 2023 Q3 法說會逐字稿

Good morning. My name is Kevin, and welcome to the Moderna's Third Quarter 2023 Earnings Call.

早安.我叫 Kevin，歡迎參加 Moderna 2023 年第三季財報電話會議。

(Operator Instructions)

（操作員說明）

Please be advised today's call is being recorded. At this time, I'd like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed.

請注意，今天的通話正在錄音。現在，我想將電話轉給 Moderna 投資者關係主管 Lavina Talukdar。請繼續。

Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's Third Quarter 2023 financial results and business updates. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website. On today's call are Stephane Bancel, our Chief Executive Officer; Stephen Hoge, our President; Arpa Garay, our Chief Commercial Officer; and Jamey Mock, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see Slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I'll turn it over to Stephane.

謝謝你，凱文。大家早安，感謝您參加今天的電話會議，討論 Moderna 2023 年第三季的財務業績和業務更新。您可以造訪我們網站的投資者部分，查看今天早上發布的新聞稿以及我們將審查的幻燈片。參加今天電話會議的是我們的執行長 Stephane Bancel；史蒂芬‧霍格，我們的總裁； Arpa Garay，我們的首席商務長；以及我們的財務長 Jamey Mock。在我們開始之前，請注意，本次電話會議將包括根據1995 年《私人證券訴訟改革法案》的安全港條款做出的前瞻性陳述。請參閱隨附簡報的幻燈片2 以及我們向SEC 提交的文件，了解以下重要風險因素：可能導致我們的實際表現和結果與這些前瞻性陳述中明示或暗示的表現和結果有重大差異。有了這個，我會把它交給史蒂芬。

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with quick review of our business for first quarter. Arpa will then give you an update on our commercial progress and plans. Jamey will present our financial results and will explain in detail the onetime charges we announced this morning in our press release. Stephen will then review our clinical programs. And I will share our key priorities for 2024 and 2025 to return Moderna to sales growth and profitability. We delivered $1.8 billion in Spikevax sales of COVID vaccine in the first quarter. Based on trends we are seeing in the U.S. COVID market in recent weeks. We expect our sales for 2023 to be at least $6 billion.

謝謝你，拉維娜。大家早安或下午好。感謝您今天加入我們。我將首先快速回顧我們第一季的業務。然後，Arpa 將向您通報我們的商業進展和計劃的最新情況。傑米將介紹我們的財務業績，並將詳細解釋我們今天早上在新聞稿中宣布的一次性費用。然後史蒂芬將審查我們的臨床計劃。我將分享我們 2024 年和 2025 年的主要優先事項，以使 Moderna 恢復銷售成長和獲利能力。第一季度，我們的新冠疫苗 Spikevax 銷售額達到 18 億美元。根據我們最近幾週在美國新冠病毒市場看到的趨勢。我們預計 2023 年的銷售額將至少 60 億美元。

We have been preparing for the 2023 for COVID launched throughout the year because the U.S. market was pivoting from a pandemic government purchase market to a commercial market. I am very pleased to report that according to IQVIA market data, we have a market share in the U.S. for 45% season to date compared to 36% for 2022. And data will show you, we even achieved a 51% market share last week in the U.S.

我們全年都在為2023年推出的新冠病毒做準備，因為美國市場正在從疫情的政府採購市場轉向商業市場。我很高興地向您報告，根據IQVIA 市場數據，我們本季迄今在美國的市佔率為45%，而2022 年為36%。數據將向您顯示，我們上週甚至達到了51% 的市場份額在美國。

This commercial performance in the U.S. market shows that Moderna can compete commercially with large established players. That will prove important as we launched RSV 2024, a combo of flu/COVID 2025. On the cost side of the company, we informed you at R&D Day that it was important for us to refile our manufacturing footprint as the world has moved from a pandemic to an endemic setting. I am pleased that our manufacturing and finance team were able to move fast and recycle manufacturing so that we can go back to 75% to 80% gross margin levels. This residing resulted in a charge of $1.6 billion, which Jamey will explain in detail in his section. Now let me turn it over to Arpa to walk you through our progress in the U.S. market.

在美國市場的商業表現表明，Moderna 可以與大型老牌企業進行商業競爭。當我們推出 RSV 2024（流感/COVID 2025 的組合）時，這一點將被證明很重要。在公司的成本方面，我們在研發日通知您，隨著世界已經從大流行到流行環境。我很高興我們的製造和財務團隊能夠快速行動並回收製造，以便我們能夠回到 75% 至 80% 的毛利率水平。這次居住導致了 16 億美元的費用，Jamey 將在他的部分中詳細解釋這一點。現在讓我把它交給 Arpa，向您介紹我們在美國市場的進展。

Thank you, Stephane, and good morning or good afternoon to everyone. Today, I will provide an update on our third quarter performance, our U.S. commercial launch progress and our preparation for our RSV launch next year. Our total sales in the third quarter came in at $1.8 billion, which includes approximately $800 million in international sales and $900 million in U.S. sales. Total sales for the first 3 quarters of the year were $3.9 billion. Turning now to our expectations for the fourth quarter and full year 2023 outlook.

謝謝你，史蒂芬，祝大家早安或下午好。今天，我將提供有關我們第三季業績、美國商業發布進展以及明年 RSV 發布準備工作的最新資訊。我們第三季的總銷售額為 18 億美元，其中包括約 8 億美元的國際銷售額和 9 億美元的美國銷售額。今年前 3 季的總銷售額為 39 億美元。現在談談我們對第四季和 2023 年全年展望的預期。

In our international business, we expect an additional $1.1 billion in sales. These sales are based on government contracts and once vaccine doses are shipped and accepted by the customer, they are not returnable. More than half of these sales have already shipped in the fourth quarter. In the U.S., we expect at least $1 billion in sales in the fourth quarter, which would bring U.S. sales to approximately $2 billion for the second half of 2023. This assumes approximately 50 million doses administered in the U.S., which would be similar to the fall season of 2022. With the $3.9 billion in sales recorded as of the end of the third quarter, expected fourth quarter sales of $1.1 billion internationally and at least $1 billion in the U.S., our updated sales outlook for 2023 is at least $6 billion.

在我們的國際業務中，我們預計銷售額將增加 11 億美元。這些銷售基於政府合同，疫苗劑量一旦發貨並被客戶接受，就不可退回。其中一半以上的銷售額已在第四季出貨。在美國，我們預計第四季度的銷售額至少為 10 億美元，這將使美國在 2023 年下半年的銷售額達到約 20 億美元。這假設在美國註射了大約 5000 萬劑疫苗，這與2022年秋季。截至第三季末銷售額為39 億美元，預計第四季國際銷售額為11 億美元，美國銷售額至少為10 億美元，因此我們更新的2023 年銷售額展望為至少60 億美元。

Now turning to the U.S. launch. The data shown here are from IQVIA. As a reminder, IQVIA data only captures the retail channel in the U.S., which includes retail pharmacies and long-term care. I'm first going to share what our weekly market share trends look like and then discuss our cumulative shares since launch and how it compares to last year. On the fifth week post launch for the week ending October 20, what you can see on the slide here is that Moderna's market share is 51%. As we look over the season to date, Moderna's cumulative market share for this season is now 45%, which is higher than the 36% market share we had in 2022. As Stephane mentioned, this progress demonstrates our ability to compete effectively in the commercial endemic market.

現在轉向美國的發布。此處顯示的數據來自 IQVIA。需要提醒的是，IQVIA 數據僅涵蓋美國的零售通路，其中包括零售藥局和長期照護。我首先將分享我們的每週市場份額趨勢，然後討論自推出以來我們的累積份額以及與去年相比如何。在發布後的第五週（截至 10 月 20 日的一周），您可以在幻燈片上看到 Moderna 的市佔率為 51%。回顧本賽季至今，Moderna 本賽季的累積市佔率現已達到 45%，高於 2022 年 36% 的市佔率。正如 Stephane 所提到的，這一進展表明我們有能力在商業領域進行有效競爭。地方性市場。

Turning now to Slide 8, which shows cumulative vaccinations in the U.S. retail pharmacy channel. This year, COVID vaccines were launched 2 weeks later than in 2022. As a result, we analyze the data on a launch adjusted basis, as shown in the graph on the slide. To do this, we look at the data based on the number of weeks post launch, rather than simply on a calendar basis. This helps us compare vaccines uptake in 2023 versus 2022.

現在轉向幻燈片 8，它顯示了美國零售藥房管道的累積疫苗接種情況。今年，新冠疫苗的上市時間比 2022 年晚了 2 週。因此，我們在上市調整後的基礎上分析數據，如投影片上的圖表所示。為此，我們根據發布後的周數而不是簡單地根據日曆查看數據。這有助於我們比較 2023 年和 2022 年的疫苗接種情況。

On the graph, the blue line represents cumulative vaccinations post launch in '22, and the red line represents cumulative vaccinations post launch this year. And on a launch adjusted basis, the total market is tracking ahead of last year's vaccination levels both on a weekly basis, but also on a cumulative basis. As a reminder, the retail channel is typically the largest segment, so these trends in the first 5 weeks are encouraging given the later launch and slightly shorter season in 2023.

圖中，藍線代表22年上市後的累積疫苗接種次數，紅線代表今年上市後的累積疫苗接種次數。在發布調整後，整個市場的每周和累積疫苗接種水準都領先於去年的疫苗接種水準。需要提醒的是，零售通路通常是最大的細分市場，因此考慮到 2023 年推出較晚且季節稍短，前 5 週的趨勢令人鼓舞。

Let's now turn to look at the channel mix in the market on Slide 9. In 2023, we expect retail and non-retail mix to evolve as the season progresses. The non-retail segment includes independent networks, health systems, U.S. government entities, clinics and other providers. Last year, this nonretail segment met up approximately 16 million doses in the season or 33% of the total market. The gray line on the graph chart CDC reported vaccinations, which capture both retail and non-retail channels in 2022. The blue line is vaccination that retail pharmacies as reported by IQVIA in 2022. The difference between these 2 lines represents the non-retail segment.

現在讓我們來看看幻燈片 9 上市場的通路組合。到 2023 年，我們預計零售和非零售組合將隨著季節的進展而演變。非零售部分包括獨立網路、衛生系統、美國政府實體、診所和其他提供者。去年，這一非零售市場銷售了約 1,600 萬劑疫苗，佔市場總量的 33%。圖表中的灰線是CDC 報告的疫苗接種情況，涵蓋2022 年零售和非零售通路的疫苗接種情況。藍線是IQVIA 報告的2022 年零售藥房的疫苗接種情況。這兩條線之間的差異代表非零售領域。

Looking at the data on the graph, you can see that the retail channel captures the majority of vaccinations early in the season. This can be seen in the narrow spread between the CDC and IQVIA data represented by the gray and blue lines, respectively. Now if you look at the seventh week of launch in 2022, the current week that we are in, in '23, you can see that the slope of the non-retail channel is increasing. We know that distributors this year have recently increased shipments to the non-retail channel, and as such, we expect non-retail as a percentage of market to grow between now and year-end. Importantly, we expect our market share to be consistent across channels and higher in 2023 than in 2022.

查看圖表上的數據，您可以看到零售通路在季節初期捕獲了大部分疫苗接種。這可以從分別以灰線和藍線表示的 CDC 和 IQVIA 數據之間的狹窄差距中看出。現在，如果您查看 2022 年發布的第七週，即我們所處的本週，23 年，您可以看到非零售通路的斜率正在增加。我們知道，今年經銷商最近增加了非零售通路的出貨量，因此，我們預計從現在到年底，非零售通路佔市場的比例將會成長。重要的是，我們預計各個通路的市佔率將保持一致，並且 2023 年的市佔率將高於 2022 年。

We are committed to focus on public health efforts to increase vaccination rates. In the United States, we are taking a multipronged approach to educate all stakeholders and increase the urgency to get vaccinated. Across the medical community, pharmacies and clinics and advocacy groups, we are providing patient education resources to help our partners encourage their patients to get their COVID vaccine this fall.

我們致力於專注於公共衛生工作以提高疫苗接種率。在美國，我們正在採取多管齊下的方法來教育所有利益相關者並提高接種疫苗的緊迫性。在整個醫學界、藥房、診所和倡導團體中，我們正在提供患者教育資源，以幫助我們的合作夥伴鼓勵他們的患者在今年秋天接種新冠疫苗。

Earlier this week, we also launched our branded direct-to-consumer campaign both on TV as well as across digital channels. For the remainder of the year, we will be amplifying education on the need for vaccination prior to gathering particularly with at-risk populations such as families and traveling during the holiday season. We are also launching a focused education effort for consumers who are infected with COVID this summer, on the importance of getting vaccinated in November and December.

本週早些時候，我們也在電視和數位管道上推出了直接面向消費者的品牌活動。在今年剩下的時間裡，我們將在與高風險族群（例如家庭和假期旅行）聚集之前加強疫苗接種必要性的教育。我們也針對今年夏天感染新冠病毒的消費者進行了一項重點教育活動，宣傳 11 月和 12 月接種疫苗的重要性。

To summarize our COVID outlook, we expect at least $6 billion of sales this year, based on the U.S. vaccination trends that signal a market of at least 50 million doses. Moderna's share, both in retail and non-retail, is expected to be consistent across channels and higher than in 2022. Vaccine administration from the retail channel are tracking ahead of last year on a launch adjusted basis, signaling strong early consumer demand.

總結我們的新冠疫情前景，根據美國疫苗接種趨勢（顯示市場至少有 5,000 萬劑疫苗），我們預計今年的銷售額至少為 60 億美元。 Moderna 在零售和非零售領域的份額預計將在各個管道保持一致，並高於 2022 年。零售通路的疫苗管理在發布調整的基礎上領先於去年，這表明早期消費者需求強勁。

Last year, only about 55% of COVID vaccinations were given by the end of October, with an additional 23 million vaccinations given in November and December. We expect the non-retail channel to increase as a percentage of the market, which will provide additional sites of vaccination for consumers to allow for a strong November and December. This year, given the later launch of vaccines, the non-retail channels are just now beginning their vaccination campaigns. To continue the momentum from our launch and supplement our customers' efforts, we will be amplifying our marketing campaigns in November and December. Let me now turn to the upcoming RSV launch in 2024. We believe we have a best-in-class product profile that can make a difference both to patients but also to our customers.

去年，到 10 月底，只有約 55% 的新冠疫苗接種完成，11 月和 12 月又接種了 2,300 萬例疫苗。我們預計非零售通路在市場中所佔的比例將會增加，這將為消費者提供更多的疫苗接種地點，從而使 11 月和 12 月的銷售強勁。今年，由於疫苗上市較晚，非零售通路的疫苗接種活動才剛開始。為了延續我們的推出動能並補充客戶的努力，我們將在 11 月和 12 月加強我們的行銷活動。現在讓我談談即將在 2024 年推出的 RSV。我們相信我們擁有一流的產品概況，可以為患者和我們的客戶帶來改變。

Our clinical profile shows strong vaccine efficacy. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of GBS in our Phase III trial. An important differentiator for our customers is that we will be the only company with ready-to-use prefilled syringes, which are preferred by pharmacists and by clinicians. We continue to expect a 2024 launch of our RSV vaccine in the U.S. and are also preparing for launches in several international markets. We're encouraged by the recent RSV launches in the market this year, beating expectations due to robust consumer awareness and demand.

我們的臨床概況顯示疫苗具有很強的功效。我們擁有完善的安全性和耐受性概況，利用了已在超過 10 億種新冠疫苗中採用的相同 mRNA 技術。此外，我們在 III 期試驗中尚未發現任何 GBS 病例。對於我們的客戶來說，一個重要的區別在於，我們將是唯一一家提供即用型預充式註射器的公司，這種注射器是藥劑師和臨床醫生的首選。我們繼續預期 RSV 疫苗將於 2024 年在美國上市，並準備在多個國際市場上市。今年市場上最近推出的 RSV 令我們感到鼓舞，由於消費者意識和需求強勁，超出了預期。

And we believe that we are well positioned for our launch in 2024. Our strong clinical profile and ready-to-use prefilled syringes are key competitive differentiators. My team and I are particularly excited about our ready-to-use prefilled syringes, given the robust demand for our COVID prefilled syringes this fall.

我們相信，我們已經做好了在 2024 年推出產品的準備。我們強大的臨床特徵和即用型預充式註射器是關鍵的競爭優勢。鑑於今年秋季對我們的新冠預灌封注射器的強勁需求，我和我的團隊對我們的即用型預灌封注射器感到特別興奮。

The majority of RSV vaccines in the U.S. will be given in the pharmacy setting. And given the ongoing pharmacy labor shortages, our ready-to-use presentation will save time and also reduce administration errors. We will be the only company with a one-step administration compared to competitive products, which require multiple preparation steps by pharmacists and clinicians. We are very excited for the launch of our RSV vaccine given the strong product profile. And the commercial team is well positioned to bring our RSV vaccine, our second respiratory vaccine to market. I will now turn it over to Jamey to provide an update on our financials.

美國的大多數 RSV 疫苗將在藥房提供。鑑於藥房勞動力持續短缺，我們的即用型簡報將節省時間並減少管理錯誤。與競爭產品相比，我們將是唯一一家採用一步式給藥的公司，競爭產品需要藥劑師和臨床醫生進行多個準備步驟。鑑於我們強大的產品概況，我們對 RSV 疫苗的推出感到非常興奮。商業團隊已做好準備將我們的第二種呼吸道疫苗 RSV 疫苗推向市場。我現在將其交給 Jamey，以提供我們財務狀況的最新資訊。

Thanks, Arpa, and hello, everyone. Today, I will review our financial performance for the third quarter and provide an updated framework for our full year 2023 financial outlook. Additionally, given we know it's top of mind for investors, we wanted to provide our early thoughts on 2024 and how we're approaching the next couple of years.

謝謝阿帕，大家好。今天，我將回顧我們第三季的財務業績，並為 2023 年全年財務展望提供更新的框架。此外，鑑於我們知道這是投資者最關心的問題，我們希望提供我們對 2024 年的早期想法以及我們如何應對未來幾年的情況。

Starting on Slide 15. Total net product sales for the quarter were $1.8 billion, down 44% year-over-year driven by lower sales volume and partially offset by a higher average selling price. Product sales were almost evenly distributed between the U.S. market and the rest of the world. We initiated product shipments to customers in mid-September for the fall booster season, following the authorization of our updated COVID-19 vaccine. Cost of sales for the third quarter of 2023 was $2.2 billion compared to $1.1 billion in the prior year. I will provide a detailed commentary on the following slides. Research and development expenses were $1.2 billion, which increased by 41% versus the prior year. This increase was driven by our expanded and maturing development pipeline with 6 products now in Phase III studies or pending approval.

從投影片 15 開始。本季產品淨銷售總額為 18 億美元，年減 44%，原因是銷量下降，但平均售價上漲部分抵銷了這一影響。產品銷售幾乎均勻分佈在美國市場和世界其他地區。在我們更新的 COVID-19 疫苗獲得授權後，我們於 9 月中旬開始向秋季加強季節的客戶發貨。 2023 年第三季的銷售成本為 22 億美元，而前一年為 11 億美元。我將在接下來的幻燈片中提供詳細的評論。研發費用為12億美元，較上年增加41%。這一增長是由我們擴大和成熟的開發管道推動的，其中 6 個產品目前處於 III 期研究或等待批准。

Selling, general and administrative expenses were $442 million, reflecting an increase of 59% year-over-year. The growth in spending was primarily driven by the build-out of our commercial activities and in particular, our launch in the U.S. commercial market. The income tax provision in Q3 was $1.7 billion, as we reported a valuation allowance against deferred tax assets of $1.7 billion.

銷售、一般及管理費用為 4.42 億美元，較去年同期成長 59%。支出的成長主要是由我們商業活動的擴展，特別是我們在美國商業市場的推出所推動的。第三季的所得稅準備金為 17 億美元，我們報告的遞延稅資產估值備抵為 17 億美元。

Under GAAP accounting rules, we are required to take a reserve, also referred to as the valuation allowance for deferred tax assets when the current year and cumulative income projection for the next 3 years is in a loss position. These losses indicate our deferred tax assets may not be fully realized. It's important to note future income from products not yet approved by regulators are excluded from these income projections, which restricts us to just our COVID vaccine, and it does not include expected future launches. In combination with our updated endemic COVID forecast, we determined it was appropriate to record a valuation allowance for our deferred tax assets. This valuation allowance does not impact cash flows nor future returns, nor the company's ability to utilize deferred tax assets in future periods.

根據GAAP會計規則，當本年度和未來3年的累計收入預測處於虧損狀態時，我們需要提取準備金，也稱為遞延所得稅資產的估值備抵。這些損失表明我們的遞延所得稅資產可能無法完全實現。值得注意的是，尚未獲得監管機構批准的產品的未來收入被排除在這些收入預測之外，這限制了我們僅生產新冠疫苗，並且不包括預期的未來發布。結合我們最新的流行病預測，我們確定為我們的遞延稅資產記錄估價備抵是適當的。此估價備抵不會影響現金流量或未來回報，也不影響公司在未來期間利用遞延稅資產的能力。

Net loss for the period was $3.6 billion compared to net income of $1 billion last year. Diluted loss per share was $9.53 compared to diluted earnings per share of $2.53 in 2022. Finally, we ended the third quarter with $12.8 billion in cash and investments, the decline versus prior quarter was driven by our operating loss and sales to be collected in Q4.

這段期間的淨虧損為 36 億美元，而去年的淨收入為 10 億美元。稀釋後每股虧損為9.53 美元，而2022 年稀釋後每股收益為2.53 美元。最後，我們在第三季結束時擁有128 億美元的現金和投資，與上一季相比下降的原因是我們的營運虧損和第四季將收取的銷售額。

Now let me come back to cost of sales on Slide 16. We now expect full year cost of sales of $5 billion driven by $1.5 billion of unit-driven expenses, which also includes royalties and $3.5 billion of inventory write-downs and charges related to CMO purchase commitments, cancellation fees and wind-down costs. As Stephane previously highlighted, in our pursuit to optimize the cost structure of our COVID-19 franchise, we undertook a strategic initiative in the third quarter to restructure our manufacturing footprint, which was built for the pandemic. As part of this initiative, we reduced our capacity and commitments with several third-party vendors. We reevaluated our raw material inventory levels and cut back on our purchase commitments for raw materials not anticipated to be consumed before expiration.

現在讓我回到投影片16 上的銷售成本。我們現在預計全年銷售成本為50 億美元，其中包括15 億美元的單位驅動費用，其中還包括特許權使用費和35 億美元的庫存減記以及與相關費用相關的費用。CMO 購買承諾、取消費用和逐步減少費用。正如 Stephane 之前所強調的那樣，為了優化 COVID-19 特許經營的成本結構，我們在第三季度採取了一項戰略舉措，以重組我們為應對疫情而建立的製造足跡。作為該計劃的一部分，我們減少了與多家第三方供應商的產能和承諾。我們重新評估了原材料庫存水平，並減少了對預計到期前不會消耗的原材料的採購承諾。

As a result, we are reporting charges of $1.6 billion, $1.4 billion of which are in Q3 and an expected $0.2 billion in Q4. The $1.4 million charge in Q3 consists of inventory write-downs of $0.9 billion and CMO wind-down costs and cancellation fees of $0.5 billion. The Q4 charge is related to CMO wind-up costs. Despite the immediate financial impact, we are confident that this strategic move will improve the efficiency of our manufacturing operations and establish a strong foundation for improved margins going forward. As part of the $1.6 billion in total restructuring charges I just mentioned, only the CMO related costs and cancellation fees are cash restructuring costs. We project this approximately $0.7 billion charge will have a payback in less than 2 years and a net cash benefit of approximately $1 billion through 2029. As I mentioned, our full year forecast for cost of sales in 2023 is now $5 billion before resizing charges of $1.6 billion.

因此，我們報告的費用為 16 億美元，其中 14 億美元發生在第三季度，預計 2 億美元將在第四季度發生。第三季的 140 萬美元費用包括 9 億美元的庫存減記以及 5 億美元的 CMO 逐步減少成本和取消費用。第四季的費用與 CMO 清盤成本有關。儘管會產生直接的財務影響，但我們相信這項策略舉措將提高我們製造業務的效率，並為未來提高利潤率奠定堅實的基礎。我剛才提到的16億美元重組費用總額中，只有CMO相關費用和取消費用是現金重組費用。我們預計這筆約7 億美元的費用將在不到2 年內收回成本，到2029 年淨現金收益將達到約10 億美元。正如我所提到的，在調整費用規模之前，我們對2023 年全年銷售成本的預測目前為50 億美元。16 億美元。

Our cost of sales for the full year is expected to be at the low end of our previous guidance of $3.5 billion to $4 billion. So now coming back to my commentary on Q3. In addition to unit-driven manufacturing costs and the cost in this initiative, we also incurred approximately $0.4 billion of inventory charges for excess and obsolete material, demand-related write-downs of our latest Spikevax product and unutilized manufacturing capacity charges.

我們全年的銷售成本預計將處於我們先前指導的 35 億至 40 億美元的低端。現在回到我對第三季的評論。除了單位驅動的製造成本和該計劃的成本之外，我們還因過剩和過時的材料而產生了約4 億美元的庫存費用、最新Spikevax 產品的與需求相關的減記以及未​​利用的製造產能費用。

Moving to Slide 17. In summary, we made substantial progress to resize our COVID cost structure and accelerated our path towards our longer-term target of 20% to 25% of sales. We expect our cost of sales to not only be at a lower level, but also to be more predictable in the future. In recent quarters, our cost of sales were highly impacted by write-offs and charges as we just addressed today and in previous calls, year-to-date write-offs and charges for inventory CMO and supplier-related commitments are 74% of sales.

轉到投影片 17。總而言之，我們在調整新冠疫情成本結構方面取得了實質進展，並加快了實現佔銷售額 20% 至 25% 的長期目標的步伐。我們預計未來的銷售成本不僅會處於較低水平，而且會更可預測。在最近幾個季度，我們的銷售成本受到沖銷和費用的嚴重影響，正如我們今天剛剛提到的，在之前的電話會議中，年初至今的庫存CMO 和供應商相關承諾的沖銷和費用佔銷售額的74% 。

Starting in 2024, we expect those to be less than 10% of sales on an annualized basis. Our capacity is now better positioned to scale with volume. At $4 billion sales level, we expect cost of sales of approximately 35%, reducing to approximately 30% and $6 billion of sales and 20% to 25% at even higher sales levels. In other words, with our resized manufacturing footprint, we now expect to achieve significant volume leverage moving forward.

從 2024 年開始，我們預計這些比例將低於年化銷售額的 10%。我們的產能現在可以更好地隨著數量的增長而擴展。在40 億美元的銷售額水準上，我們預期銷售成本約為35%，在銷售額達到60 億美元時，將減少至約30%，在更高的銷售水準下，將減少至20% 至25 %。換句話說，隨著我們調整製造規模，我們現在預計將實現顯著的銷售槓桿。

Let's now move to Slide 18. While we intend to continue to focus on GAAP results, we wanted to give you a view of our financial results in Q3 with and without the resizing and tax valuation allowance charges. While our total GAAP net loss in the third quarter was $3.6 billion, our loss excluding these charges would have been $0.5 billion.

現在讓我們轉到投影片 18。雖然我們打算繼續關注 GAAP 業績，但我們希望讓您了解我們在第三季度的財務業績，包括和不包括調整規模和稅收估價津貼費用。雖然我們第三季的 GAAP 淨虧損總額為 36 億美元，但如果不計這些費用，我們的虧損將為 5 億美元。

Now let's turn to our updated 2023 financial framework on Slide 19. As Arthur mentioned earlier, we now expect product sales for 2023 of at least $6 billion for the full year, which is comprised of $3.9 billion of sales through the third quarter, an additional $1.1 billion of international sales in Q4 and at least $1 billion of Q4 sales from the U.S. As explained earlier, we now expect cost of sales for the full year of approximately $5 billion which includes resizing charges of $1.6 billion.

現在讓我們轉向幻燈片19 上更新的2023 年財務框架。正如Arthur 之前提到的，我們現在預計2023 年全年產品銷售額至少為60 億美元，其中包括截至第三季度的39 億美元銷售額，以及額外的銷售額。第四季國際銷售額為11 億美元，第四季美國銷售額至少為10 億美元。如前所述，我們現在預計全年銷售成本約為50 億美元，其中包括16 億美元的規模調整費用。

For R&D and SG&A, we now expect full year expenses to be approximately $6.3 billion, with approximately $4.8 billion in research and development. Our R&D spend is slightly higher than the $4.5 billion previously forecasted, which is mainly driven by business development activities as well as additional investments in our late-stage clinical trials. Our forecast for SG&A expenses remain consistent at approximately $1.5 billion. We now expect a full year tax expense of approximately $0.8 billion to $1 billion driven by the $1.7 billion increase in the deferred tax allowance I referenced earlier. And finally, we now expect capital expenditures of approximately $0.9 billion, down from our previous guidance of $1 billion.

對於研發和 SG&A，我們現在預計全年費用約為 63 億美元，其中研發費用約為 48 億美元。我們的研發支出略高於先前預測的 45 億美元，這主要是由業務開發活動以及後期臨床試驗的額外投資所推動的。我們對 SG&A 費用的預測保持一致，約 15 億美元。我們現在預計，由於我之前提到的遞延稅項津貼增加了 17 億美元，全年稅收支出約為 8 億至 10 億美元。最後，我們現在預計資本支出約為 9 億美元，低於我們之前 10 億美元的指引。

Before I get into the specifics on 2024 and 2025, I wanted to share with you our principles on how we are operating the company today on our plans over the next 3 years. We are laser focused on making our COVID franchise profitable in 2024 and beyond. We look at our Spikevax product profitability, excluding research and development costs for our future pipeline, and we believe our recent resizing efforts will ensure that our COVID franchise is a continuous and increasing source of income and cash generation. At the same time, we also recognized a significant and unique opportunity for organic sales growth ahead of us with our late-stage pipeline. We will be disciplined in our investment approach and adjust R&D and SG&A based upon the sales performance of our product lines, which in 2024 is still mostly COVID, but we expect it to also include RSV.

在詳細介紹 2024 年和 2025 年之前，我想與您分享我們今天如何經營公司以及未來 3 年計畫的原則。我們專注於讓我們的新冠肺炎特許經營業務在 2024 年及以後實現盈利。我們著眼於 Spikevax 產品的獲利能力，不包括我們未來管道的研發成本，我們相信我們最近的規模調整工作將確保我們的新冠特許經營權成為持續且不斷增長的收入和現金產生來源。同時，我們也認識到我們的後期產品線面臨著有機銷售成長的重要而獨特的機會。我們將嚴格控制我們的投資方式，並根據我們產品線的銷售業績調整研發和銷售、一般管理費用（SG&A），到2024年，我們的產品線仍然主要是新冠病毒，但我們預計也包括RSV。

We expect this investment in our late-stage pipeline will result in a loss over the next 2 years, but help us to just break even starting in 2026. We believe our current balance sheet is more than sufficient to fund our plans without the need to raise equity. We are also not planning to repurchase shares in the intermediate term. Stepping back, we believe this is an unparalleled opportunity to impact the lives of patients while creating shareholder value at the same time.

我們預計對後期管道的這項投資將在未來 2 年內導致虧損，但有助於我們在 2026 年開始實現收支平衡。我們相信，我們目前的資產負債表足以為我們的計劃提供資金，而無需籌集股本。我們也不打算在中期回購股票。退一步來說，我們相信這是一個無與倫比的機會，可以影響患者的生活，同時創造股東價值。

Moving to Slide 21. Let's start with our view on sales over the next couple of years. We are expecting sales to hit a low point in 2024 at approximately $4 billion. The biggest change year-over-year is related to our signed APAs. We currently have $1 billion of COVID-related APAs for delivery in 2024. Recall that our first half sales in 2023 of $2.1 billion were mostly deferrals from our 2022 existing contracts. So we expect minimal sales in the first half of 2024.

轉向幻燈片 21。讓我們從我們對未來幾年銷售的看法開始。我們預計銷售額將在 2024 年降至約 40 億美元的低點。年比最大的變化與我們簽署的預約定價安排有關。目前，我們有 10 億美元的新冠肺炎相關預約定價安排將於 2024 年交付。回想一下，我們 2023 年上半年銷售額 21 億美元大部分是 2022 年現有合約的延期付款。因此，我們預計 2024 年上半年的銷售量將微乎其微。

For the U.S., we expect 2024 to be at least $2 billion and believe it will grow over time. Lastly, we expect approximately $1 billion from RSV and other international COVID sales. And finally, in 2025, we expect to return to growth. Let me finish by giving you a more fulsome view on 2024 and our thinking on 2025.

對於美國，我們預計 2024 年將至少達到 20 億美元，並相信這一數字會隨著時間的推移而增長。最後，我們預計 RSV 和其他國際新冠肺炎銷售額約為 10 億美元。最後，我們預計到 2025 年將恢復成長。最後，我將向您提供對 2024 年更全面的看法以及我們對 2025 年的思考。

Starting with 2024. As I just explained, we expect sales to be approximately $4 billion. Cost of sales are expected to be approximately 35% of sales, R&D expenses of approximately $4.5 billion in 2024 would be down 6%. In 2024, the majority of our R&D expenses are for registration trials, which are now mostly committed. I will speak to our view on 2025 R&D expenses in a moment. SG&A expenses of approximately $1.3 billion in 2024 would be down 13%. We expect taxes to be negligible in 2024 and capital expenditures to be similar to 2023 at $0.9 billion.

從 2024 年開始。正如我剛才所解釋的，我們預計銷售額約為 40 億美元。預計到 2024 年，銷售成本將佔銷售額的 35% 左右，研發費用將下降 6%，約 45 億美元。 2024年，我們的研發費用大部分用於註冊試驗，目前大部分已投入使用。我稍後會談談我們對2025年研發費用的看法。 2024 年，SG&A 費用約為 13 億美元，將下降 13%。我們預期 2024 年的稅收可以忽略不計，資本支出與 2023 年類似，為 9 億美元。

In summary, for 2024, Spikevax will generate nearly $1 billion of income. When we combine that with our estimated investments in R&D and capital expenditures, our cash balance is projected to be approximately $9 billion at the end of 2024.

總而言之，到 2024 年，Spikevax 將產生近 10 億美元的收入。如果將其與我們在研發和資本支出方面的估計投資相結合，到 2024 年底，我們的現金餘額預計約為 90 億美元。

Now for our preliminary thoughts on 2025. As mentioned earlier, sales will return to growth. Cost of sales will improve with the increased sales growth. R&D will be flat to down, and we have much greater flexibility for reduction, given that only approximately half of our current R&D spending levels for registration of trials are committed for 2025.

現在我們對 2025 年的初步想法。如前所述，銷售額將恢復成長。銷售成本將隨著銷售成長的增加而改善。研發支出將持平甚至下降，而且考慮到我們目前用於試驗註冊的研發支出水準只有大約一半會在 2025 年承諾，因此我們有更大的削減彈性。

SG&A will be flat to down, taxes will continue to be negligible, and capital expenditures will be materially lower after the completion of our facilities in the U.K., Canada and Australia in the first half of 2025. In summary, our COVID operating income will grow and our investments will remain flat or lower leading us to an estimated ending cash balance of approximately $6 billion to $7 billion in 2025. Finally, during this period, we expect to launch 5 new products to help us break even in 2026. So with that, I'll now turn the call over to Stephen.

2025 年上半年我們在英國、加拿大和澳洲的設施竣工後，SG&A 將持平甚至下降，稅收將繼續微不足道，資本支出將大幅降低。總而言之，我們的新冠疫情營業收入將增長我們的投資將保持不變或較低，預計2025 年期末現金餘額約為60 億至70 億美元。最後，在此期間，我們預計將推出5 款新產品，以幫助我們在2026 年實現收支平衡。 ，我現在將電話轉給史蒂芬。

Good morning or good afternoon. Today, I will do a quick review of our clinical programs. Many of the details from these programs were shared at our R&D Day in September. I will also review the Phase III trial designs for our combination flu and COVID vaccine, mRNA-1083 and the Phase III trial design for our INT in non-small cell lung cancer. During R&D Day, we shared the significant progress we've made through the year in advancing our late-stage pipeline, creating the opportunity to have up to 15 product launches in the next 5 years through 2025 and subject to regulatory review and approvals, we anticipate launches for our RSV vaccine, our flu vaccine, a next-generation COVID vaccine and our combination flu and COVID vaccine.

早安或下午好。今天，我將快速回顧我們的臨床計畫。這些計劃的許多細節已在九月的研發日上分享。我也會回顧我們的流感和新冠聯合疫苗 mRNA-1083 的 III 期試驗設計以及我們的 INT 用於非小細胞肺癌的 III 期試驗設計。在研發日期間，我們分享了我們這一年在推進後期研發管線方面取得的重大進展，創造了在截至2025 年的未來5 年內推出多達15 個產品的機會，並且需要獲得監管部門的審查和批准，我們預計將推出我們的 RSV 疫苗、流感疫苗、下一代新冠疫苗以及流感和新冠疫苗聯合疫苗。

Looking beyond 2025, we have a diverse pipeline of other vaccines, cancer therapies and rare metabolic disease medicines. We're very excited by the potential benefits, these medicines offer across a diverse range of therapeutic areas. Slide 25 is an overview of our respiratory vaccines pipeline. Our leading pipeline includes commercial and Phase III programs against COVID, RSV and flu as well as earlier-stage next-generation programs in COVID and flu and multiple illuminations. We recently shared positive top line Phase I/II data from our combination flu and COVID vaccine, mRNA-1083. And on the heels of this success, we've started and are rapidly enrolling a Phase III study for mRNA-1083 in adults 50 and older.

展望 2025 年以後，我們擁有多種其他疫苗、癌症療法和罕見代謝疾病藥物的產品線。我們對這些藥物在各個治療領域提供的潛在益處感到非常興奮。投影片 25 概述了我們的呼吸道疫苗產品線。我們領先的產品線包括針對新冠肺炎、呼吸道合胞病毒和流感的商業和第三階段項目，以及針對新冠肺炎和流感的早期階段下一代項目以及多種照明。我們最近分享了流感和新冠肺炎合併疫苗 mRNA-1083 的 I/II 期陽性數據。繼這項成功之後，我們已經開始並正在迅速進行 50 歲及以上成年人的 mRNA-1083 III 期研究。

Slide 26 shows the Phase III design for mRNA-1083. The Phase III study is a randomized, stratified, observer-blind, active control study, evaluating the immunogenicity and safety of 1083 compared to co-administered flu and COVID vaccines. The study will enroll 8,000 participants overall, with 2 cohorts of 4,000 participants stratified by age 65 years and older and 50 to 64 years of age.

幻燈片 26 顯示了 mRNA-1083 的 III 期設計。 III 期研究是一項隨機、分層、觀察者盲法、主動對照研究，評估 1083 與同時接種流感和新冠疫苗相比的免疫原性和安全性。研究總共將招募 8,000 名參與者，其中 2 個隊列，每組 4,000 名參與者，依年齡分為 65 歲及以上和 50 至 64 歲。

Both cohorts will receive mRNA-1083 or in a control arm, an age recommended licensed quadrivalent flu vaccine plus our approved COVID vaccine. Study participants will be followed for 6 months.

兩個隊列都將接受 mRNA-1083 或對照組，即年齡建議的許可四價流感疫苗加上我們批准的新冠疫苗。研究參與者將被追蹤 6 個月。

Now next on Slide 27 is an overview of our latent and other vaccines pipeline. As previously announced, our Phase III in vaccine efficacy and safety of our CMV vaccine in women of child-bearing age is now fully enrolled, including the adolescent cohort. The study is accruing cases, and we look forward to vaccine efficacy data when it becomes available. Earlier-stage clinical programs against EBV, HIV, VZV, HSV and against Nororovirus and Lyme disease continue to progress.

接下來的投影片 27 概述了我們的潛在疫苗和其他疫苗管道。如同先前所宣布的，我們的 CMV 疫苗在育齡婦女中的疫苗功效和安全性 III 期現已全部入組，包括青少年群體。該研究正在增加病例，我們期待獲得疫苗功效數據。針對 EBV、HIV、VZV、HSV 以及針對諾羅病毒和萊姆病的早期臨床計畫繼續取得進展。

Slide 28 is an overview of our therapeutics pipeline. We're proud of the progress across cancer, rare diseases and other areas. Many of the details of these programs were highlighted at our recent R&D Day, and I refer you to that presentation on our website. Notable since R&D Day is the continued rapid enrollment of the INT Phase III adjuvant melanoma study, which has seen a great deal of interest from investigators and patients since presentation of the Phase II data at ASCO earlier this year.

幻燈片 28 概述了我們的治療方案。我們為癌症、罕見疾病和其他領域的進展感到自豪。這些計劃的許多細節在我們最近的研發日上得到了強調，我建議您參閱我們網站上的簡報。自研發日以來值得注意的是 INT III 期輔助黑色素瘤研究的持續快速入組，自今年早些時候在 ASCO 上公佈 II 期數據以來，研究人員和患者對此表現出了極大的興趣。

As previously announced, before the end of the year, we will conduct another analysis of the Phase II study with longer follow-up time at approximately 3 years, and we are looking forward to sharing that data. INT is also moving forward in other types of cancer with the initiation of a second Phase III study in adjuvant non-small cell lung cancer. The Phase III design for adjuvant non-small cell lung cancer is shown on slide 29. It is a randomized placebo blind -- double-blind, placebo and active comparator controlled study of a combination of INT plus KEYTRUDA versus placebo plus KEYTRUDA in patients with non-small cell lung cancer.

正如先前宣布的，今年年底前，我們將對 II 期研究進行另一次分析，追蹤時間較長，約 3 年，我們期待分享該數據。 INT 也在其他類型的癌症領域取得進展，啟動了第二項針對輔助非小細胞肺癌的 III 期研究。非小細胞肺癌輔助治療的III 期設計如幻燈片29 所示。這是一項隨機安慰劑盲－雙盲、安慰劑和活性對照對照研究，針對以下患者進行INT 加KEYTRUDA 與安慰劑加KEYTRUDA的組合：非小細胞肺癌。

The study will enroll approximately 900 patients with Stage II to IIIB tumors who were resected and previously treated with adjuvant chemotherapy. Each patient will receive up to 9 doses of INT administered intramuscularly every 3 weeks with KEYTRUDA administered every 6 weeks in the active arm or 9 doses of a placebo injection administered every 3 weeks and KEYTRUDA at every 6 weeks in the comparator arm. The primary endpoint of the study is disease-free survival. Key secondary endpoints include overall survival, distant metastasis-free survival and patient-reported outcomes. This study marks an important milestone in our collaboration with our partner, Merck, and our shared commitment to rapidly bring INT to patients.

該研究將招募約 900 名 II 期至 IIIB 期腫瘤患者，這些患者已被切除並先前接受過輔助化療。每位患者將接受最多 9 劑 INT，每 3 週肌肉注射一次，主動組每 6 週注射一次 KEYTRUDA，或每 3 週注射 9 劑安慰劑，對照組每 6 週注射一次 KEYTRUDA。研究的主要終點是無疾病存活期。關鍵的次要終點包括總存活期、無遠端轉移存活期和患者報告的結果。這項研究標誌著我們與合作夥伴默克合作的一個重要里程碑，也是我們共同致力於將 INT 快速帶給患者的承諾。

With that, I'll turn it over to Stephane.

有了這個，我會把它交給史蒂芬。

Our focus is to return Moderna's sales growth and profitability. To achieve that, we have 3 priorities, priority number one, commercial execution. Our market share in the U.S. demonstrates we can compete. We are focused on launching RSV in 2024. We believe we have best-in-class profile for RSV vaccine, high-efficacy, good safety profile and the easiest to use in pharmacies or doctor's office. As you know, pharmacy chains are in challenges given the workload, especially in the fall seasons. The 2 of vaccines on the market today are very complicated to prepare before injection; one is nine steps and one is four steps. Now we launched pre-fille syringe and, as Arpa said, we're very excited about that. And from the discussion that has with the leadership of pharmacies, I believe that this will be an important differentiation.

我們的重點是回報 Moderna 的銷售成長和獲利能力。為了實現這一目標，我們有 3 個優先事項，第一要務是商業執行。我們在美國的市佔率顯示我們有競爭力。我們的重點是在 2024 年推出 RSV。我們相信我們擁有一流的 RSV 疫苗、高效、安全性好，並且最容易在藥房或醫生辦公室使用。如您所知，鑑於工作量，連鎖藥局面臨挑戰，尤其是在秋季。目前市面上的兩種疫苗在註射前的準備工作非常複雜；一層是九步，一層是四步。現在我們推出了預填充注射器，正如 Arpa 所說，我們對此感到非常興奮。從與藥房領導層的討論來看，我相信這將是一個重要的區別。

Our commitment to combo vaccine should work in 2025. And as you know, flu is a higher volume market than COVID. In the U.S., for example, flu is around 3x the number of doses compared to the COVID market. We these new product launches in '24, '25 and the combination of COVID sales in the endemic setting, we believe Moderna will be in sales growth again in 2025.

我們對組合疫苗的承諾應該會在 2025 年發揮作用。如您所知，流感是一個比新冠病毒更大的市場容量。例如，在美國，流感的疫苗接種量是新冠病毒市場的約 3 倍。我們在 24 年和 25 年推出了這些新產品，再加上流行病環境下的新冠病毒銷售情況，我們相信 Moderna 將在 2025 年再次實現銷售成長。

Priority number two, disciplined investments. We'll be disciplined in our investments and cycle them based on our sales performance. As you saw, we have taken bold actions, we signed our manufacturing footprint in the third quarter. The team is not done, and there are many continuous improvement projects to drive a reduction in cost of manufacturing. We also look at our R&D costs and we consider partnering some programs, if needed, to allow us to be responsible and disciplined about our costs.

第二要務是嚴格的投資。我們將嚴格控制投資，並根據銷售績效進行投資循環。正如您所看到的，我們採取了大膽的行動，我們在第三季簽署了我們的製造足跡。團隊尚未完成，還有許多持續改善項目來推動製造成本的降低。我們也會考慮我們的研發成本，如果需要，我們會考慮與一些專案合作，以使我們能夠對我們的成本負責並遵守紀律。

For SG&A, as Jamey mentioned, we are currently going through our 2024 budget and our goal is to have a lower spending SG&A 2024 than we had in 2023. We still plan to keep SG&A flat in 2025 versus 2024. We are launching respiratory products in 2024 and 2025 and we anticipate the same teams we sell them. We also expect productivity gains as we improve our commercial operations.

對於SG&A，正如Jamey 所提到的，我們目前正在審議2024 年的預算，我們的目標是2024 年的SG&A 支出低於2023 年。我們仍計劃在2025 年保持SG&A 與2024 年持平。我們將在2024 年推出呼吸產品2024 年和 2025 年，我們預期我們出售的球隊是相同的。我們也預計，隨著我們改善商業運營，生產力也會提高。

As Jamey mentioned, we expect to break even in 2026. Priority number three. Executing on our late-stage pipeline to drive sales growth. As you all know, we have an exciting late-stage pipeline with 6 Phase III assets. For respiratory programs, RSV, flu, NextGen Covid, mRNA-1283 and COVID plus flu combo that Stephen just spoke about. One Latent program CMV, which is fully enrolled in its Phase III and accruing cases. One Oncology program INT in melanoma and as Stephen mentioned, in lung cancer.

正如 Jamey 所提到的，我們預計在 2026 年實現收支平衡。第三個優先事項。執行我們的後期管道以推動銷售成長。眾所周知，我們擁有令人興奮的後期研發管線，其中包括 6 個三期資產。對於呼吸系統項目，RSV、流感、NextGen Covid、mRNA-1283 和 Stephen 剛才談到的 COVID 加流感組合。 One Latent 計畫 CMV 已完全進入 III 期並正在累積病例。一項針對黑色素瘤的腫瘤學計畫 INT，正如史蒂芬所提到的，針對肺癌。

We look forward to having and sharing 3 year of INT data from a melanoma study before the end of this year. If the data are strong, we believe it will be the basis for regulatory discussions for potential activated approval. We have been investing in building a factory in Marlborough, Massachusetts to enable the commercial launch for INT. Thanks to the mRNA platform with this, we have an exciting pipeline with up to 15 launches in the next 5 years. We are the largest late-stage pipeline of mRNA company in the world, and we'll continue to focus to deliver the greatest possible impact to people for mRNA medicine. I've never been more excited about the potential we have to deliver for patients. The actions we are taking help us to execute on that vision. With this operator, we'll be happy to take questions now.

我們期待在今年年底前獲得並分享黑色素瘤研究的 3 年 INT 數據。如果數據強勁，我們相信這將成為潛在激活批准的監管討論的基礎。我們一直在馬薩諸塞州馬爾伯勒投資建造一家工廠，以實現 INT 的商業推出。由於 mRNA 平台，我們擁有了令人興奮的產品線，在未來 5 年內將推出多達 15 個產品。我們是世界上最大的 mRNA 公司後期研發管線，我們將繼續致力於為 mRNA 藥物為人們帶來最大的影響。我對我們為患者提供的潛力感到前所未有的興奮。我們正在採取的行動有助於我們實現這個願景。有了這位接線員，我們現在很樂意回答問題。

(Operator Instructions)

（操作員說明）

Our first question comes from Huidong Wang with Barclays.

我們的第一個問題來自巴克萊銀行的王惠東。

I have 2 questions regarding the commercial questions. First, you did mention in 2026, you're looking to have a breakeven. And when we take a quick look based on your 2024 and 2025 outlook, it seems the total cost could be in the $8 billion to $9 billion that range. Could you give us a sense what could be the additional sales if we're using 2024 guidance as a base point? And the second very quickly regarding the manufacturing resizing. After resizing, what is the full capacity regarding doses? And what percentage of the manufacturing will be internal in 2024 and 2025?

我有兩個關於商業問題的問題。首先，您確實提到，您希望在 2026 年達到收支平衡。當我們根據 2024 年和 2025 年的展望快速瀏覽時，總成本似乎可能在 80 億至 90 億美元的範圍內。您能否告訴我們，如果我們使用 2024 年指引作為基點，額外銷售額可能是多少？第二個非常快速地涉及製造規模調整。調整大小後，劑量方面的全部容量是多少？ 2024 年和 2025 年，內部製造的比例是多少？

Maybe I'll take the first one for a further question. So in terms of 2026, thanks for the question. Let's talk about how we're thinking about it. So we mentioned $4 billion in 2024, approximately $4 billion. And this is all about our late-stage pipeline coming to fruition. So in 2024, we'll launch RSV, it's mostly kind of in the second half year sales, and then we'll have a full year of 2025, so that will provide growth. We will also come to market with flu in 2025.

也許我會用第一個來提出進一步的問題。就 2026 年而言，謝謝您的提問。讓我們談談我們是如何考慮的。所以我們提到2024年40億美元，大約40億美元。這一切都是為了我們的後期管道取得成果。因此，在 2024 年，我們將推出 RSV，這主要是在下半年銷售，然後我們將在 2025 年全年實現成長，這將帶來成長。我們也將在 2025 年將流感產品推向市場。

We'll also come to market with the combination of flu and COVID in 2025. Again, it depends on timing. But by 2026, we should have a full portfolio. We're not going to say what the exact sales numbers are, but you mentioned $8 to $9 billion in costs, not exactly sure where you get there unless you're assuming a certain sales line on that. But let me go back to what we tried to lay out here. If you assume, for instance, $6 billion of sales, we should have 30% of costs or $8 billion of sales, we should have 25% of cost. And then we've said historically at our R&D Day that we need $25 billion overall to make this investment, which should average $5 billion a year.

我們也將在 2025 年將流感和新冠疫情結合的產品推向市場。同樣，這取決於時機。但到 2026 年，我們應該會有完整的產品組合。我們不會透露確切的銷售數字是多少，但您提到了 8 至 90 億美元的成本，除非您假設有一定的銷售線，否則不確定您會達到什麼水平。但讓我回到我們試圖在這裡闡述的內容。例如，如果假設銷售額為 60 億美元，我們應該承擔 30% 的成本；或假設銷售額為 80 億美元，我們應該承擔 25% 的成本。然後我們在研發日上曾說過，我們總共需要 250 億美元來進行這項投資，平均每年應為 50 億美元。

So hopefully, we're giving you enough pieces without officially guiding any kind of numbers in 2026. But here's what's also important is if those sales, don't come to fruition we are telling you that we will adjust our expenditures in our investment. So that's -- we hope that we are -- they will, we are confident in our pipeline, but should it not happen, then we were prepared to adjust our investment. I missed the second part of the question. Can you maybe repeat the second part of your question, I apologize, I missed it.

因此，希望我們能夠在 2026 年為您提供足夠的產品，而無需正式指導任何類型的數字。但同樣重要的是，如果這些銷售沒有實現，我們會告訴您我們將調整我們的投資支出。所以，我們希望他們會的，我們對我們的管道充滿信心，但如果這種情況沒有發生，那麼我們準備好調整我們的投資。我錯過了問題的第二部分。您能否重複一下問題的第二部分，抱歉，我錯過了。

Basically after manufacturing resizing, what is the full capacity regarding doses? And then what percentage will be internal?

基本上在製造調整尺寸後，劑量方面的全部容量是多少？那麼內部的百分比是多少呢？

So -- as we try to lay out here and are showing you this capacity is built for volume leverage. So we at least put $10 billion of sales on that page, and it will require no additional capacity. We will complete of course, over the next 1.5 years, the U.K. facility, the Canada facility and Australia facility. But for the respiratory framework, we need no more, at least $10 million. I won't project beyond that, but that should answer that question. INT is little bit different, and we are building that and getting that ready for commercial purposes, but we're built for volume leverage moving forward.

因此，正如我們試圖在這裡展示並向您展示的那樣，這種容量是為數量槓桿而建造的。因此，我們至少在該頁面上投入了 100 億美元的銷售額，並且不需要額外的容量。當然，我們將在未來 1.5 年內完成英國工廠、加拿大工廠和澳洲工廠。但對於呼吸系統，我們不需要更多，至少需要 1000 萬美元。我不會超出這個範圍，但這應該可以回答這個問題。 INT 有點不同，我們正在建立它並為商業目的做好準備，但我們是為未來的銷售槓桿而建造的。

Our next question comes from Salveen Richter with Goldman Sachs.

我們的下一個問題來自高盛的 Salveen Richter。

Two for me here. One is you provided guidance of about $4 billion between COVID and RSV. On the forward here for 2024. Could you just speak to the contribution from each and how you're thinking about flu monotherapy and the second question is that your financial framework for 2025 includes the ability to flex R&D and SG&A. And are there any parameters you can share on the range of this flexibility and how you would prioritize R&D programs in development?

這裡給我兩個。其中之一是您為新冠肺炎和呼吸道合胞病毒之間提供了約 40 億美元的指導。關於 2024 年的展望。您能否談談每個人的貢獻以及您對流感單一療法的看法，第二個問題是您 2025 年的財務框架包括靈活研發和銷售管理費用的能力。關於這種靈活性的範圍，以及您將如何優先考慮開發中的研發項目，您是否可以分享任何參數？

So on the $4 billion, we're not going to break out the $1 billion that we attributed to RSV and COVID. All we can say is we've talked about our PDUFA date and that we filed and see a certain amount of countries across the globe. I will also say, as I mentioned in her prepared remarks that we are super confident in the product profile. We are encouraged by the market and how it's already started from an uptake perspective, and we think we will compete very well.

因此，在 40 億美元中，我們不會突破 RSV 和新冠病毒造成的 10 億美元。我們所能說的就是我們已經討論了 PDUFA 日期，並且我們提交並查看了全球一定數量的國家。我還要說，正如我在她準備好的演講中提到的那樣，我們對產品概況非常有信心。我們對市場以及它已經從吸收的角度開始感到鼓舞，我們認為我們將具有良好的競爭能力。

(technical difficulty)

（技術難度）

and beyond. As it pertains to the flexing on our spending for 2025, obviously, I don't know, 80% of our expenses or investments are in R&D, so $4.5 billion for R&D and $1.3 billion for SG&A. So that, as I mentioned, 50% of the current spending levels is not committed. So we have time to make decisions and watch the market to be able to say what amount of registrational trials and what amount of R&D are we going to spend in 2025. So hopefully, that gives you a sense for how much is still the ability to flex. We also have other levers that we can pull, et cetera. SG&A, we also have some flexibility, probably not to the same magnitude, but there's still some amount of flexibility to bring that down from a variable expense perspective.

超越。由於涉及我們 2025 年支出的彈性，顯然，我不知道，我們 80% 的支出或投資都用於研發，因此研發費用為 45 億美元，SG&A 費用為 13 億美元。因此，正如我所提到的，目前支出水準的 50% 尚未承諾。因此，我們有時間做出決定並觀察市場，以便能夠確定 2025 年我們將花費多少註冊試驗和研發費用。因此，希望這能讓您了解仍有多少能力柔性。我們還有其他可以拉動的槓桿，等等。 SG&A，我們也有一定的靈活性，可能沒有達到同樣的程度，但從可變費用的角度來看，仍然有一定的靈活性來降低這種靈活性。

And Savi, this is Stephane, maybe just to add to Jamey's point on the R&D, as I mentioned in my remarks, if we have to, we would be open, of course, to partnerships some of those programs, which is an important way we reflect the early number based on where the sales are as Jamey mentioned, which is if sales offering to our plan that we're going to be okay. If the sales are below, we will be very open to partnering us. We've done that in the past, the team knows how to do it, but we will be disciplined about our investments in the business based on where the sales line is.

薩維，這是史蒂芬，也許只是為了補充傑米關於研發的觀點，正如我在發言中提到的，如果我們必須這樣做，我們當然會與其中一些項目建立夥伴關係，這是一種重要的方式我們根據 Jamey 提到的銷售情況來反映早期的數字，也就是說，如果銷售符合我們的計劃，我們就會沒問題。如果銷售額低於以下，我們將非常願意與我們合作。我們過去就這樣做過，團隊知道如何做，但我們將根據銷售線的位置來嚴格控制我們對業務的投資。

Our next question comes from Eliana Merle with UBS.

我們的下一個問題來自瑞銀集團的 Eliana Merle。

This is Sarah on for Eliana. First, I guess, can you talk about in 2024, again, on that $1 billion RSV international sales number. Are you expecting any contribution from flu in '24 and maybe how you're thinking about it into '25. And then on CMV, can you talk about where you are in cases and how they're tracking versus R&D Day, where I think you said 1/4 of them were currently tracked, that would be great.

這是埃利安娜的莎拉。首先，我想您能否再次談談 2024 年 RSV 國際銷售額 10 億美元的情況。您是否預期 24 年流感會帶來任何影響？也許您對 25 年有何看法？然後在 CMV 上，您能否談談您的情況以及與 R&D Day 相比，它們的跟踪情況如何，我認為您說目前正在跟踪其中的 1/4，那就太好了。

So thanks, Sarah. I'll take the first part and then hand it over to Stephen on CMV. So there is no flu contribution in our 2024 sales outlook of approximately $4 billion. So in that $1 billion or that is solely RSV and other COVID international sales. We do, as I mentioned into answering Salveen's question. We do expect to launch flu in our combination products sometime in 2025, and we'll see what we've projected at that time.

謝謝，莎拉。我將完成第一部分，然後將其交給 CMV 上的 Stephen。因此，我們 2024 年約 40 億美元的銷售前景中沒有流感的貢獻。因此，這 10 億美元中僅包含 RSV 和其他新冠肺炎國際銷售額。正如我在回答 Salveen 的問題時提到的那樣，我們確實這麼做了。我們確實預計在 2025 年的某個時候在我們的組合產品中推出流感產品，屆時我們將看到我們的預測。

And on the CMV question, thanks for that. So yes, we did update that we're about a quarter away through the case accrual back in R&D Day. I think the next -- we continue to recruit case at a steady pace. I do think the next update will provide is likely our vaccine's day in the spring.

關於 CMV 問題，謝謝。所以，是的，我們確實更新了，在研發日，我們的病例累積進度大約剩下四分之一。我認為接下來——我們將繼續以穩定的速度招募案例。我確實認為下一次更新很可能是春季的疫苗接種日。

Our next question comes from Terence Flynn with Morgan Stanley.

我們的下一個問題來自摩根士丹利的特倫斯·弗林。

I know GSK has provided an estimate in terms of size of the RSV market about GBP 5 billion and Pfizer has given some metrics as well. Given what we're seeing now with these early launches, can you provide us with your assessment of total market size here? And then given some of your comments on competing with larger companies as you're doing in COVID now, where ultimately do you see your market share shaking out in the RSV space.

我知道葛蘭素史克 (GSK) 提供了 RSV 市場規模約 50 億英鎊的估計，輝瑞 (Pfizer) 也給出了一些指標。鑑於我們現在所看到的這些早期發布的情況，您能否向我們提供您對此處總市場規模的評估？然後考慮到您對與大公司競爭的一些評論，就像您現在在新冠疫情中所做的那樣，您最終會看到您在 RSV 領域的市場份額發生變化。

Thank you for the question. In terms of the total RSV market, as I mentioned earlier, we're excited by the uptake and the consumer awareness of the market overall. And our projections are similar to what both GSK and Pfizer have already guided. In terms of our market share with RSV, we have not yet provided or are ready to provide any forward-looking projections on share. But we are very excited about our strong product profile both in terms of efficacy, safety. And as I mentioned, are ready-to-use prefilled syringes. So we will be leveraging the learnings and the success from our COVID commercial launch this year and applying them to RSV next year.

感謝你的提問。就整個 RSV 市場而言，正如我之前提到的，我們對整個市場的吸收和消費者意識感到興奮。我們的預測與葛蘭素史克和輝瑞已經指導的類似。就我們與 RSV 的市場佔有率而言，我們尚未提供或準備提供任何前瞻性的份額預測。但我們對我們在功效和安全性方面強大的產品形象感到非常興奮。正如我所提到的，是即用型預充式註射器。因此，我們將利用今年 COVID 商業發布的經驗教訓和成功經驗，並將其應用於明年的 RSV。

Yes, Just to add to Arpa, Terence, it's Stephane. The point that Arpa and I made about the market share of COVID is what I think is very important. I think some people believe that because we are a new company in commercial, we're not able to compete and I think the market share data that Arpa shared show that is able to compete, and we will continue to improve things that we are doing because we're not only improving the start of our culture, as you know but the share already moving from 36% last year to 45% cumulative so far in the season.

是的，補充一下阿帕，特倫斯，我是史蒂芬。我認為 Arpa 和我對新冠病毒市場份額的觀點非常重要。我認為有些人認為，因為我們是商業領域的新公司，所以我們無法競爭，我認為 Arpa 分享的市場份額數據表明我們有能力競爭，我們將繼續改進我們正在做的事情因為正如你所知，我們不僅改善了我們文化的開端，而且該份額已從去年的36% 上升到本賽季迄今的累積45%。

I think it's already a demonstration of what the team is able to achieve. And the season is not over, so I see that 51% so let's see what this was finished when the season is over. But basically, the defection we have, as I mentioned, have been speaking to pharmacies leadership, and they are all I think a very big workload issue, as you know, we have been tracking some pharmacy chains in the U.S. as we speak. And you think about the season, there to report the normal business of pharmaceutical preparations and then the flu and then the COVID and then RSV and as I mentioned, those 2 of our products, if you just download the label of those products from FDA website, then you look at how many steps they have. It's a very complicated and we talk to pharmacy leadership. They don't know how they're going to deal with that type of workload. And so coming with pre-filled syringe is a tremendous differentiator and we have very good efficacy with a very good safety profile. We really believe that we have the best-in-class product in the market and that means if you don't commit it is going to translate into a very good effect.

我認為這已經證明了團隊能夠取得的成就。賽季還沒結束，所以我看到了 51%，所以讓我們看看賽季結束後完成了什麼。但基本上，正如我所提到的，我們的叛逃一直在與藥房領導層交談，我認為它們都是一個非常大的工作量問題，正如你所知，我們一直在追蹤美國的一些藥房連鎖店。你想想這個季節，報告藥物製劑的正常業務，然後是流感，然後是新冠病毒，然後是呼吸道合胞病毒，正如我提到的，我們的這兩種產品，如果你只是從FDA 網站下載這些產品的標籤，然後你看看他們有多少步驟。這是一個非常複雜的問題，我們與藥房領導層進行了交談。他們不知道將如何處理這種類型的工作量。因此，使用預填充注射器是一個巨大的差異化因素，我們具有非常好的功效和非常好的安全性。我們確實相信我們擁有市場上一流的產品，這意味著如果您不承諾，它將會轉化為非常好的效果。

Our next question comes from Jessica Fye with JPMorgan.

我們的下一個問題來自摩根大通的傑西卡·菲伊。

Just a couple coming back around to one that I think some others were trying to get at, but maybe a little differently. What we think about breakeven in 2026, what are you contemplating in that sales number embedded in your assumption? Does it reflect just respiratory vaccines? Or are you considering INT could be on the market then? And then second, I know you said the percentage of non-retail jobs would grow as the season progresses from where it has been so far this season. Do you believe that the proportion of COVID shots running through the retail channel has shifted at all bigger picture in 2023 relative to 2022? Or should we think of that proportion as remaining similar year-over-year?

只有一對夫婦回到了我認為其他人試圖達到的目標，但也許有點不同。我們對 2026 年損益兩平有何看法？您對假設中的銷售數字有何看法？它僅反映呼吸道疫苗嗎？還是您正在考慮 INT 會上市？其次，我知道你說過，隨著季節的進展，非零售工作的比例將會從本季迄今的水平增長。您是否認為 2023 年透過零售通路投放的新冠疫苗比例相對 2022 年發生了根本性變化？或者我們是否應該認為該比例與去年同期保持相似？

Again, without getting in too much detail on 2026 in terms of how we think about it. I mean the best way to keep going back to that late-stage pipeline that we've been talking to you about RSV, flu, our combination, our next-gen COVID product as well, will all be very much there for the year of 2026 and we are confident in all those product profiles and how we will compete. As I mentioned, at 6%, our cost of sales at $6 billion, sorry, our cost of sales would be 30% at $8 billion, our cost of sales will be 25%. And of course, we'll try to improve on that. And that will give us the envelope for how much we can continue to invest. In the future products, which we said we'll launch 15 by 2028. That will be all of our latent portfolio that will be our INT portfolio. That will be our rare disease portfolio. So I think that's as much as we can say right now. I just want everybody to know that we are very committed to breaking even in a year, and we have a lot of flexibility, both from a growth standpoint and a disciplined investment standpoint.

再次強調，我們對於 2026 年的看法並沒有提供太多細節。我的意思是，繼續回到我們一直在與你們討論的有關RSV、流感、我們的組合以及我們的下一代新冠產品的後期管道的最佳方式，都將在今年實現。2026 年，我們對所有這些產品概況以及我們的競爭方式充滿信心。正如我所提到的，在 6% 的情況下，我們的銷售成本為 60 億美元，抱歉，我們的銷售成本將為 30%，在 80 億美元的情況下，我們的銷售成本將為 25%。當然，我們會盡力改進這一點。這將為我們提供繼續投資的限度。在未來的產品中，我們表示將在 2028 年之前推出 15 個產品。這將是我們所有的潛在產品組合，也就是我們的 INT 產品組合。這將是我們的罕見疾病投資組合。所以我想我們現在能說的就這麼多了。我只是想讓每個人都知道，我們非常致力於在一年內實現收支平衡，而且無論是從成長的角度還是從嚴格的投資角度來看，我們都有很大的靈活性。

And I can take the second question on the percentage of non-retail. So as expected, in 2023, the retailers has been the majority of the market with more than 90% of the volume during the first few weeks. However, we're now beginning to see a shift towards more non-retail channels, as I had mentioned. We are seeing increased shipments to IDNs, to clinics, to pediatricians as of the recent weeks. And as I think about full year 2023, I believe the retail mix will be stronger than in 2022 and could land at about 70% to 80% of total vaccinations whereas in 2022, we saw that the retail channel was only about 2/3 of the mix.

我可以回答關於非零售百分比的第二個問題。因此，正如預期的那樣，到 2023 年，零售商將佔據市場的大部分，在最初幾週內佔據了 90% 以上的銷售量。然而，正如我所提到的，我們現在開始看到更多的非零售通路的轉變。截至最近幾週，我們發現發送至國際化域名 (IDN)、診所和兒科醫生的出貨量有所增加。當我考慮2023 年全年時，我相信零售組合將比2022 年更強，並可能佔疫苗接種總數的70% 至80% 左右，而在2022 年，我們看到零售通路僅佔疫苗接種總量的2/3 左右。混合。

Our next question comes from Luca Issi with RBC Capital.

我們的下一個問題來自 RBC Capital 的 Luca Issi。

Maybe circling back on the P&L. I appreciate all the effort on resizing manufacturing and the focus on gross margin. But how should we think about OpEx plus CapEx as COVID numbers continue to come down. We've seen BioNTech and Pfizer materially realigning OpEx plus CapEx to their top line. I believe BioNTech lowered by $600 million this year and Pfizer by $1 billion this year and $2.5 billion next year. However, your OpEx plus CapEx has not materially changed this year and you anticipate that the next year is going to be generally flat to down. So can you just maybe comment on why you think that's the right strategic decision for the organization?

也許回到損益表上。我感謝在調整製造規模和關注毛利率方面所做的所有努力。但隨著新冠疫情數字持續下降，我們應該如何考慮營運支出和資本支出。我們已經看到 BioNTech 和輝瑞對營運支出和資本支出進行了實質調整，以達到其營收目標。我相信 BioNTech 今年減少了 6 億美元，輝瑞今年減少了 10 億美元，明年減少了 25 億美元。然而，您的營運支出加上資本支出今年沒有發生重大變化，您預計明年將整體持平甚至下降。那麼您能否評論一下為什麼您認為這對組織來說是正確的策略決策？

And then maybe second question on RSV, obviously, impressive initial launch by GSK and Pfizer and the differentiation of your product, but what's the latest thinking on whether the vaccine is needed every year or less frequently than that. Is there a scenario with Pfizer and GSK penetrated market pretty aggressively this year and then you face an uphill battle next year as it turns down that you need a vaccine maybe every other year and not every year? Any thoughts there, much appreciated.

然後可能是關於RSV 的第二個問題，顯然，葛蘭素史克和輝瑞的首次推出令人印象深刻，以及您的產品的差異化，但是關於是否每年都需要疫苗或比這更少的頻率，最新的想法是什麼。是否會出現這樣的情況：輝瑞和葛蘭素史克今年相當積極地滲透市場，然後明年你將面臨一場艱苦的戰鬥，因為你可能每隔一年而不是每年都需要疫苗？有任何想法，非常感謝。

Maybe I'll take the first -- the second part of that question and then hand it over to Jamey for first. So on RSV and the need for it, obviously, we're continuing to follow the public health situation in terms of the rate of occurrence RC epidemic this year. At this point, I think we don't have data yet on whether or not it will ultimately be an annual or something less than annual, say, every 2- or 3-year vaccination regime. I think like everybody else, we'll be looking to our data, the other manufacturers' data as well as the public health, the epidemiologic data to guide that decision.

也許我會回答這個問題的第一部分——第二部分，然後首先將其交給傑米。因此，關於 RSV 及其需求，顯然，我們將繼續關註今年 RC 流行發生率的公共衛生狀況。目前，我認為我們還沒有關於最終是每年一次還是少於每年一次的數據，例如每兩年或三年一次的疫苗接種制度。我認為像其他人一樣，我們將參考我們的數據、其他製造商的數據以及公共衛生、流行病學數據來指導這項決定。

There are plenty of vaccines for which there is an approach flu as an example, where there's a seasonal vaccination approach, both because of the benefit offered by the vaccine, but also because of the convenience of just making sure that every season, every year, people are reminded to get that vaccine. So the ultimate decision on whether this is going to be recommended is not ours to manufacture, all of public health officials based on a number of factors, which will include the EPI and the data we'll provide but other factors as well and we'll work to make sure they have the data they need to make that decision.

有很多疫苗，以流感為例，有季節性疫苗接種方法，這既是因為疫苗提供的好處，也是因為確保每個季節、每年都接種疫苗很方便。提醒人們接種疫苗。因此，是否建議這樣做的最終決定不是由我們做出的，所有公共衛生官員都根據許多因素做出決定，其中包括 EPI 和我們將提供的數據，但也包括其他因素，我們將努力確保他們擁有做出決定所需的數據。

And I'll take the first part. Thanks, Luca, for the question. I think the short answer is the opportunity set ahead of us, and we are acting. So you referenced some of our competitors, I just want to break that down. We are super encouraged by the opportunity for additional growth and our ability to impact patients. And we have this 15 products that we think will launch by 2028 or by 2025. And we think that's the right thing to do. We have to grow out of our -- we have to grow this company and to be able to afford the investments to be able to capture the unparalleled opportunity for this. And I think we are acting.

我將講第一部分。謝謝盧卡提出的問題。我認為簡短的答案是我們面前有機會，而我們正在採取行動。所以你提到了我們的一些競爭對手，我只想對此進行分解。我們對額外成長的機會和影響患者的能力感到非常鼓舞。我們認為這 15 種產品將在 2028 年或 2025 年推出。我們認為這是正確的做法。我們必須發展我們的公司，我們必須發展這家公司，並且能夠負擔得起投資，以便能夠抓住無與倫比的機會。我認為我們正在行動。

I believe we are acting. I think I mentioned everything that we're doing from a cost of sales perspective. And so I think that is very much in line and sized appropriately to have volume leverage when it comes because it will come. And we are saying in 2024, we can adjust both R&D and SG&A down to a good level, down 6% R&D, down 13% also on SG&A. We are largely committed to our registrational trials for 2024. So as I mentioned, we don't have as much flexibility in that particular year. But by 2025, we have even more flexibility. So we're prepared to take action should we need to, but we're very optimistic about the pipeline that's coming. And hopefully, this is coming through growth and we'll still be able to afford much of this investment.

我相信我們正在行動。我想我從銷售成本的角度提到了我們正在做的一切。因此，我認為這非常符合且規模適當，以便在它到來時具有成交量槓桿，因為它會到來。我們說，到 2024 年，我們可以將研發和 SG&A 都調整到一個好的水平，研發下降 6%，SG&A 也下降 13%。我們主要致力於 2024 年的註冊試驗。因此，正如我所提到的，我們在那一年沒有那麼多的靈活性。但到 2025 年，我們將擁有更大的彈性。因此，我們準備在需要時採取行動，但我們對即將到來的管道非常樂觀。希望這是透過成長實現的，我們仍然能夠負擔大部分投資。

Yes. I'm Stephane, just maybe adding to Jamey, who said it super well. As you know, we have a platform company. And the profitability of technical success of those programs, we feel very good about. If you just look at with COVID and Phase III RSV -- sorry, and Phase III for RSV and Phase III for flu, we have 3 out of 3 positive Phase III. This is not your industry average. So we think we can create value, increase return on capital for shareholders by investing that capital through high-quality projects that are in late search pipeline. As I said, we have the largest late-stage pipeline of any company with 6 programs right now. And as soon as the (inaudible) which is very, very soon, there's going to be 7 programs. We believe the best way to create results for our shareholders is to invest that capital to drive sales growth and profitability.

是的。我是史蒂芬，也許只是補充一下傑米，他說得非常好。如您所知，我們有一家平台公司。這些專案的技術成功所帶來的獲利能力，我們感覺非常好。如果你只看一下新冠病毒和第三階段RSV——抱歉，以及RSV第三階段和流感第三階段，我們有三分之三的第三階段陽性。這不是您的行業平均值。因此，我們認為，透過將資本投資於處於後期搜尋管道的高品質項目，我們可以創造價值，提高股東的資本回報率。正如我所說，我們目前擁有 6 個項目，是所有公司中規模最大的後期研發管線。一旦（聽不清楚）很快就會有 7 個節目。我們相信，為股東創造成果的最佳方式是將資金投入以推動銷售成長和獲利能力。

Our next question comes from Michael Yee with Jefferies.

我們的下一個問題來自 Jefferies 的 Michael Yee。

This is Dina on for Mike. I just wanted to get a sense of your assumptions for Q4 COVID jabs and what are you seeing in Q4 right now? How much of that is actually jabs and actual injections versus channel fill? And just a follow-up on that. Now that you've seen sort of half of the 2023 fall season play out, what are your assumptions for 2024 and 2025 for COVID. Are you essentially assuming that the same people who got vaccinated this year will continue to get COVID vaccine every year.

這是迪娜為麥克代言的。我只是想了解一下您對第四季度新冠疫苗接種的假設以及您現在在第四季度看到了什麼？其中有多少實際上是刺戳和實際注射與通道填充？這只是後續行動。現在您已經看到 2023 年秋天已經過了一半，您對 2024 年和 2025 年的新冠疫情有何假設？您基本上是否假設今年接種疫苗的人每年都會繼續接種新冠疫苗？

In terms of the fourth quarter '23 jabs, what we saw in 2022 is there is a significant portion, about 45% of the total COVID vaccination happening in November and December. This year, we're expecting a similar split, likely larger given that we launched 2 weeks later into the season in 2023 than we did last year. And what we are hearing from our different non-retail customers as well as our retail pharmacy partners, they're planning vaccination campaigns and marketing efforts to really capture on the November and December month. So in total, we do anticipate getting to at least 50 million doses this year. And we do believe that November and December will be a strong month for us. In terms of 2024, our assumption is everyone who has gotten their booster in 2023, will at least get their booster also in 2024 and beyond. Now given the higher burden of disease with COVID, as consumers become more understanding of the annual recommendations, and as the convenience of getting both flu and COVID becomes more normalized, we do believe over time, we'll start to see some increase in the overall COVID market.

就 23 年第四季的疫苗接種而言，我們在 2022 年看到，有很大一部分（約 45%）發生在 11 月和 12 月。今年，我們預計也會出現類似的情況，考慮到我們在 2023 年賽季比去年晚兩週推出，因此可能會出現更大的情況。我們從不同的非零售客戶以及零售藥局合作夥伴那裡了解到，他們正在計劃疫苗接種活動和行銷工作，以便在 11 月和 12 月真正發揮作用。因此，我們預計今年總共將獲得至少 5,000 萬劑疫苗。我們確實相信 11 月和 12 月對我們來說將是一個強勁的月份。就 2024 年而言，我們的假設是每個在 2023 年獲得加強劑的人至少也會在 2024 年及以後獲得加強劑。現在，考慮到新冠病毒造成的疾病負擔更高，隨著消費者對年度建議的了解越來越多，並且感染流感和新冠病毒的便利性變得更加正常化，我們確實相信，隨著時間的推移，我們將開始看到購買流感疫苗的人數增加。整體新冠病毒市場。

Our next question comes from Hartaj Singh with Oppenheimer.

我們的下一個問題來自哈塔吉·辛格和奧本海默。

I just got a question on the combination programs. And just to give a little bit of frame the question, in other therapeutic areas, aside from vaccines for infectious diseases, for example, oncology, monotherapy treatments generally tend to be a minority of treatments, 10%, 15%, 20%. Currently, monotherapy vaccines dominate the market in COVID-19 flu. So when you get the combination vaccines going, do you imagine -- does your market research tend to suggest that you would again, probably a combination approach might dominate that versus a monotherapy approach, singular vaccines going forward? And then secondly, will the cost of goods sold be any different for the combination versus the monotherapy products.

我剛剛有一個關於組合程序的問題。為了稍微說明這個問題，在其他治療領域，除了傳染病疫苗之外，例如腫瘤學，單一療法通常只佔少數，分別為 10%、15%、20%。目前，單一療法疫苗在 COVID-19 流感市場上佔據主導地位。因此，當您開始使用組合疫苗時，您是否會想像 - 您的市場研究是否傾向於表明您會再次（與單一療法相比，組合方法可能會主導單一疫苗）？其次，組合產品與單一療法產品的銷售成本是否會有所不同。

Thank you for the question. So we do anticipate that our combination vaccine will take a substantial share of the monotherapy vaccines that are available. We have seen in the pediatric vaccine market that upon availability of combinations, you see very strong uptake in conversion from mono to combinations, and we expect a similar trend in the adult market. From our market research, we have heard consistently from consumers that they prefer one shot over multiple shots. From a customer perspective, we are hearing as Stephane had mentioned, just with workload issues, 1 shot saves a lot of time and also helps them to get more patients protected. And from a broader health care system and government and payer perspective, we are hearing an increased need to help get greater uptake and compliance in adult vaccinations. And our health care authorities believe that combinations can help actually boost the vaccination rates. So we are very excited about our combination products in the future and think this could really be an inflection point for respiratory vaccines.

感謝你的提問。因此，我們確實預期我們的聯合疫苗將佔據現有單一療法疫苗的很大一部分。我們在兒科疫苗市場上看到，在提供組合疫苗後，您會看到從單一疫苗到組合疫苗的轉換非常強烈，我們預計成人市場也會出現類似的趨勢。根據我們的市場調查，我們不斷聽到消費者表示，他們更喜歡一次拍攝而不是多次拍攝。從客戶的角度來看，正如 Stephane 所提到的，僅僅考慮工作量問題，1 次注射可以節省大量時間，也有助於他們保護更多患者。從更廣泛的醫療保健系統以及政府和付款人的角度來看，我們聽到越來越需要幫助提高成人疫苗接種的接受度和合規性。我們的衛生保健當局相信，聯合用藥實際上有助於提高疫苗接種率。因此，我們對未來的組合產品感到非常興奮，並認為這確實可能成為呼吸道疫苗的轉折點。

Yes, this is Stephane just to add to past comments. During COVID, we have been discussing a lot with health care ministers and the topic of vaccination combination has come a lot. And as you think, especially outside the U.S., where you have a lot of (inaudible) system where you have one payer, the government taking care of people from birth to death basically. We are very, very interested in combinations because they know that participants of the country got the vaccine, the production has got several viruses, which prevent hospitalization.

是的，我是 Stephane，只是為了補充過去的評論。疫情期間，我們和衛生部長討論了很多，疫苗組合的話題也來了很多。正如你所想，特別是在美國之外，那裡有很多（聽不清楚）系統，只有一個付款人，政府基本上照顧人們從出生到死亡。我們對組合非常非常感興趣，因為他們知道該國的參與者接種了疫苗，生產過程中含有多種病毒，可以防止住院。

As you know, we've done a partnership with some countries like the U.K., Canada, and Australia and through those negotiations, the concept of combination was critical in the decision making because they see the population getting older. They were ready actually with a number of hospitalizations will just go up over time and the ability to prevent that when you see shortages of healthcare worker, and as you project those shortages in the future is a key determination of the decision. So I think we integrated healthcare system, the drive to go to combo will move even faster, but actually in commercial markets like the U.S. market.

如您所知，我們已經與英國、加拿大和澳洲等一些國家建立了合作夥伴關係，透過這些談判，聯合的概念在決策中至關重要，因為他們看到人口正在老化。他們實際上已經做好了準備，隨著時間的推移，住院人數只會增加，當你看到醫護人員短缺時，有能力防止這種情況發生，並且當你預測未來這些短缺時，這是決定的關鍵決策。因此，我認為我們整合了醫療保健系統，走向組合的動力將會更快，但實際上是在美國市場等商業市場。

Yes. And as, maybe I'll take the cost of sales question. Thank you for it. So this provides a substantial margin expansion opportunity. So if you think about our cost of sales, the smallest portion is our drug substance. So it's our actual mRNA and that's a very small portion of our overall cost of sales. Everything from drug product in terms of the cost to finish the product and the presentation type, whether it's PFS or a vial or whatever, that now gets cut in half. So when we sell to, it's a very limited amount of cost increase versus a single presentation. So it does provide a significant margin expansion opportunity.

是的。也許我會回答銷售成本問題。謝謝你。因此，這提供了巨大的利潤擴張機會。因此，如果您考慮我們的銷售成本，最小的部分是我們的原料藥。所以這是我們實際的 mRNA，只占我們總銷售成本的一小部分。從藥品到完成產品的成本和展示類型，無論是 PFS 還是小瓶還是其他什麼，現在都減少了一半。因此，當我們銷售時，與單一演示相比，成本增加量非常有限。因此，它確實提供了重要的利潤擴張機會。

Our next question comes from Boran Wang with Guggenheim Securities.

我們的下一個問題來自古根漢證券公司的王柏蘭。

Appreciate you guys sharing early thoughts on '24 and beyond. For '24 specifically, can you talk about some of the contribution from COVID and RSV in terms of split. It sounds like you plan to get the ground running there in RSV. International, how are you thinking about the longer-term contribution from COVID as competitor premiums expire and with flu, with the comments on marking '25 wondering if you had any recent conversations with the regulators there in terms of potential approval?

感謝你們分享關於 '24 及以後的早期想法。具體來說，對於 24 世紀，您能談談 COVID 和 RSV 在分割方面的一些貢獻嗎？聽起來您計劃在 RSV 中開始運行。在國際上，您如何看待隨著競爭對手保費到期和流感帶來的新冠疫情的長期貢獻，以及標記“25”的評論，想知道您最近是否與那裡的監管機構就潛在批准進行了任何對話？

About international sales? Thank you for the question. In terms of our expectations in 2024, we have put about $1 billion across international COVID and RSV. We do anticipate a strong launch in the second half of the year with RSV. And on the international side for COVID, we are continuing to pursue multiple options across a number of countries. In Japan, we will be in a fully commercial market is our expectation where we will be competing for the Japanese business. In the EU, we continue to work with countries on agreements to secure our COVID-19 vaccine. As publicly disclosed, the EU has renegotiated their contract with Pfizer earlier this year. So the EU demand has been substantially satisfied in many markets, but we are hearing from individual member states that they are looking for a second supplier for vaccines. And we are in those discussions right now, both at a country level, but also at a European commission level to see if a joint procurement agreement can be established in 2024.

關於國際銷售？感謝你的提問。就 2024 年的預期而言，我們已投入約 10 億美元用於應對國際新冠肺炎和呼吸道合胞病毒。我們確實預計 RSV 將在今年下半年強勢推出。在國際方面，針對新冠疫情，我們正在繼續在多個國家尋求多種選擇。在日本，我們期望我們將處於一個完全商業化的市場，我們將在其中競爭日本業務。在歐盟，我們繼續與各國​​合作達成協議，以確保我們的 COVID-19 疫苗的安全。據公開披露，歐盟已於今年稍早與輝瑞重新談判了合約。因此，歐盟的需求在許多市場已得到基本滿足，但我們從個別成員國得知，他們正在尋找第二家疫苗供應商。我們現在正在國家層級和歐盟委員會層級進行這些討論，看看是否可以在 2024 年達成聯合採購協議。

And thank you for the flu question. So as you referenced, we had really strong data out of our P303 Phase III study for flu that we released at R&D Day. We're excited about that. We are engaging right now with multiple regulators about the pathway to licensure. I don't have an update about all those conversations because they're happening as we speak. But we will, once we have clarity across all markets, on the pathway licensure to provide an update.

謝謝你提出流感問題。正如您所提到的，我們在研發日發布的 P303 III 期流感研究中獲得了非常強大的數據。我們對此感到興奮。我們目前正在與多個監管機構就獲得許可的途徑進行接觸。我沒有所有這些對話的最新消息，因為它們正在我們說話的時候發生。但一旦我們明確了所有市場的情況，我們將在許可途徑上提供最新資訊。

Thank you. Ladies and gentlemen, this does conclude the Q&A portion of today's conference. Ending the call itself. You may now disconnect, and have a wonderful day.

謝謝。女士們、先生們，今天會議的問答部分到此結束。自行結束通話。您現在可以斷開連接，並度過美好的一天。