Sanofi SA (SNY) 2024 Q4 法說會逐字稿

Hello, everyone. This is Thomas Kudsk Larsen from the Sanofi IR Team. Welcome to the Q4 and full year 2024 conference call for investors and analysts. As usual, you can find the slides on sanofi.com. Please turn to slide 3.

大家好。這是賽諾菲 IR 團隊的 Thomas Kudsk Larsen。歡迎參加 2024 年第四季及全年投資者和分析師電話會議。像往常一樣，您可以在 sanofi.com 上找到幻燈片。請翻到幻燈片 3。

Here, we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements, which are subject to substantial risks and uncertainties that may cause actual results to differ materially. We encourage you to read the disclaimer in our slide presentation. In addition, we refer you to our Form 20-F on file with the US SEC and our French registration document for a description of these risk factors.

這裡，我們有通常的前瞻性陳述。我們想提醒您，本次電話會議中提供的資訊包含前瞻性陳述，這些陳述受重大風險和不確定性的影響，可能導致實際結果大不相同。我們鼓勵您閱讀投影片簡報中的免責聲明。此外，請參閱我們向美國證券交易委員會提交的 20-F 表和法國註冊文件，以了解這些風險因素的描述。

Financials reported are under the new reporting scope that excludes Opella, Consumer Health. As usual, we will be making comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are in millions of euros and for Q4 2024, unless stated otherwise.

報告的財務數據屬於新的報告範圍，不包括 Opella 和消費者健康業務。像往常一樣，我們將使用固定匯率和其他非國際財務報告準則指標對我們的業績做出評論。除非另有說明，所用數字以百萬歐元為單位，且針對 2024 年第四季。

Please turn to slide 4. First, we have a presentation, then we will take your questions. Because this is full year results, we have a few more slides. We still have time for lots of questions as we added 15 minutes to the call time on top of the usual 1 hour. With Q&A, we have Brian, Olivier, Thomas, to cover our global businesses as well as Roy, our General Counsel; and Brendan, Head of Manufacturing and Supply.

請翻到幻燈片 4。首先，我們有一個演示，然後我們會回答您的問題。因為這是全年業績，所以我們還有幾張投影片。我們仍然有時間回答很多問題，因為我們在通常的 1 小時通話時間上增加了 15 分鐘。在問答環節，我們邀請了 Brian、Olivier、Thomas 來負責我們的全球業務，以及我們的總法律顧問 Roy；以及製造和供應主管布倫丹（Brendan）。

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With this, I'll hand you over to Paul.

說完這些，我就把你交給保羅。

Well, thank you, Thomas. Hello, everyone, on the call. We've made significant progress in 2024 towards becoming a focused, science-driven biopharma company. Our strategic progress was emphasized by the decision to sell a controlling stake in Opella and further prioritize R&D. On the business, we achieved double digit sales growth with strong contribution from launches.

好吧，謝謝你，托馬斯。大家好，我是電話裡的。我們在 2024 年取得了重大進展，致力於成為一家專注、科學驅動的生物製藥公司。出售 Opella 控股權並進一步優先考慮研發的決定突顯了我們的策略進步。在業務方面，我們實現了兩位數的銷售成長，其中主要得益於新產品的強勁貢獻。

This included Beyfortus that achieved blockbuster status in its first full year of sales. In R&D, we're pleased with the positive Phase 3 results of fitusiran, rilzabrutinib and tolebrutinib. They provide the foundation for potential launches this year, underpinning our sustainable growth. We are thrilled by the Phase 2 of duvacatode that is ready to move to Phase 3, pending regulatory feedback. Pooman will share more pipeline details later.

其中包括 Beyfortus，其在第一年完整銷售就取得了轟動的地位。在研發方面，我們對 fitusiran、rilzabrutinib 和 tolebrutinib 第三階段的正面結果感到滿意。它們為今年可能推出的產品奠定了基礎，支撐了我們的永續發展。我們對 duvacatode 的第 2 階段感到非常興奮，該階段已準備好進入第 3 階段，等待監管部門的回饋。Pooman 稍後將分享更多管道細節。

Looking at Q4 on slide 6, we reported double digit sales growth for a third consecutive quarter, supported by our key drivers, vaccines, Dupixent and pharma launches. Taking a closer look at the launches on slide 7. In Q4, Bay Florida sales were as high as those in the first nine months of the year combined.

查看投影片 6 上的第四季度，我們報告連續第三個季度實現兩位數的銷售成長，這得益於我們的關鍵驅動因素、疫苗、Dupixent 和藥品發布的推動。仔細看看第 7 張投影片上的發表會。第四季度，佛羅裡達灣的銷售額與今年前九個月的銷售額總和一樣高。

We now have expanded RSV protection to more than 6 million babies around the world. In hemophilia, an increasing number of patients switched to ALTUVIIIO from both factor and non-factor therapies. We're seeing strong patient benefits, and sales reached almost EUR0.250 billion in Q4. We are confident in our expectations that Ultivio will become a blockbuster this year.

現在，我們已將 RSV 保護範圍擴大到全球 600 多萬名嬰兒。在血友病方面，越來越多的患者從因子療法和非因子療法轉向 ALTUVIIIO。我們看到了病患的巨大利益，第四季的銷售額達到了近2.5億歐元。我們對 Ultivio 今年將成為一部賣座作品充滿信心。

Moving to slide 8. Dupixent exceeded the target of EUR13 billion in sales, driven by the demand for more than 1,000,000 patients globally. In Q4, Dupixent grew by 16% from strong prescription trends in all geographies.

移至幻燈片 8。受全球超過 1,000,000 名患者的需求推動，Dupixent 的銷售額超過了 130 億歐元的目標。第四季度，由於所有地區處方趨勢強勁，Dupixent 成長了 16%。

In the US, Dupixent continued its leadership in new-to-brand prescriptions across all indications, in line with the first nine months of the year. US Sales growth in the quarter reflected fewer business days compared to prior quarters and the normal year end gross to net adjustments.

在美國，Dupixent 繼續在所有適應症的新品牌處方中保持領先地位，與今年前九個月的表現一致。本季美國銷售額的成長反映了與前幾個季度相比工作日的減少和正常的年末毛利與淨利的調整。

In countries outside the US, Dupixent delivered more than EUR3.5 billion on a full year basis. In COPD, we are in the early stages of the launch, and we're seeing positive feedback from patients and prescribers. Expect the inflection point to be this year and COPD to become an important growth driver due to the large unmet medical need.

在美國以外的國家，Dupixent 全年獲利超過 35 億歐元。在 COPD 領域，我們正處於發布的早期階段，並且看到了來自患者和處方人員的正面回饋。預計今年將出現轉折點，並且由於大量未滿足的醫療需求，COPD 將成為重要的成長動力。

As we expand the benefits of Dupixent to more patients, we're pleased with the continued work on new indications, including, EoE for children in the EU, CSU outside Japan and BP globally. New uses, increased penetration in approved indications and further geographic expansion are all important future drivers for Dupixent.

隨著我們讓更多患者受益於 Dupixent，我們對新適應症的持續研究感到高興，其中包括歐盟兒童的 EoE、日本以外的 CSU 和全球的 BP。新的用途、在已批准適應症中的滲透率的提高以及進一步的地理擴張都是 Dupixent 未來發展的重要驅動力。

Moving to slide 9. 2024 marked a sales record for our vaccines business, crossing the EUR8 billion milestone, up by 13.5%. This performance was driven by Beyfortus, offering a marked reduction in hospitalization across more than 20 countries with all infant programs. We are the only RSV mAb with real world data showing greater than 80% effectiveness in more than 100,000 babies.

轉到第 9 張投影片。這一成績得益於 Beyfortus 的推動，其所有嬰兒計畫為 20 多個國家的嬰兒住院人數提供了顯著減少。我們是唯一擁有真實世界數據顯示對超過 10 萬名嬰兒有效率超過 80% 的 RSV mAb。

Our flu franchise was resilient, keeping its status as the world leader. 2024 sales exceeded initial expectations, driven by our differentiated flu zone high dose and flu block. In Q4, we also made significant progress with our vaccines pipeline with the start of six new vaccine studies, including the Phase 3 study for a pneumo vaccine, PCV21 in children. Our R&D efforts in vaccines continue to be recognized by health authorities with the FDA granting fast-track designation to our three new Phase 1/2 programs.

我們的流感藥物系列具有很強的韌性，並保持了世界領先地位。由於我們差異化的流感區域高劑量和流感阻斷，2024 年的銷售額超過了最初的預期。第四季度，我們的疫苗研發管線也取得了重大進展，啟動了六項新的疫苗研究，其中包括兒童肺炎疫苗 PCV21 的 3 期研究。我們在疫苗方面的研發努力繼續得到衛生當局的認可，FDA 為我們三個新的 1/2 期項目授予了快速通道資格。

I'm pleased to share with you Sanofi's remarkable achievement in the 2024 Access to Medicine Index. We have improved our ranking and moving from 8th to 3rd place, underscoring our commitment to global health. Important factors for this result are governance of access, R&D and product delivery.

我很高興與大家分享賽諾菲在2024年藥物可及指數中取得的顯著成就。我們的排名有所上升，從第 8 位上升至第 3 位，這凸顯了我們對全球健康的承諾。造成此結果的重要因素是准入、研發和產品交付的治理。

The Sanofi Global Health Unit plays an important role by delivering crucial medicines from the Impact Brand portfolio to 30 low- and middle-income countries. Ending on such a positive note, I would like to take this opportunity to thank all Sanofians for their continued commitment to improve the lives of millions of patients. Thank you.

賽諾菲全球健康部門透過向 30 個中低收入國家提供 Impact Brand 產品組合中的關鍵藥物發揮重要作用。最後，我想藉此機會感謝所有賽諾菲人持續致力於改善數百萬患者的生活。謝謝。

I'll now hand over to Francois, our CFO, for more details on the financials.

現在我將把電話交給我們的財務長弗朗索瓦 (Francois)，提供有關財務狀況的更多詳細資訊。

Thank you, Paul, and hello to everyone. Before I begin, just a reminder that our Q4 and full year results reflect our new reporting scope, excluding Opelar. In the quarter, net sales increased by 10.3% at constant exchange rates to EUR10.6 billion, marking our third consecutive quarter of double-digit growth. As mentioned earlier by Paul, growth was driven by new product launches as well as Dupixent. Gross margin was 74.3%, down slightly from the previous year, primarily due to the absence of COVID revenues in 2024.

謝謝你，保羅，大家好。在我開始之前，我想提醒一下，我們的第四季度和全年業績反映了我們新的報告範圍，不包括 Opelar。本季度，淨銷售額以固定匯率計算成長 10.3% 至 106 億歐元，這是我們連續第三個季度實現兩位數成長。正如保羅之前提到的，成長是由新產品的發布以及 Dupixent 推動的。毛利率為 74.3%，較前一年略有下降，主要原因是 2024 年沒有 COVID 收入。

Excluding this COVID impact, our gross margin increased by 0.8%. The increase in operating expenses was driven by R&D, reflecting a high activity level in the quarter and brought us in line with our commitments for the full year. Business EPS was EUR1.31 mainly reflecting a lower gross margin and the increase in R&D and a higher tax rate following the OECD Pillar 2 implementation.

除掉 COVID 的影響，我們的毛利率增加了 0.8%。營業費用的增加主要由研發推動，反映了本季的高活動水平，並使我們達到了全年的承諾。業務每股收益為 1.31 歐元，主要反映了毛利率下降、研發支出增加以及經合組織第二支柱實施後稅率提高。

Now turning to our full year results. Net sales increased by 11.3% at constant exchange rates to EUR41.1 billion driven by our new product launches, including Beyfortus that became a blockbuster, as well as Dupixent that exceeded our ambition of EUR13 billion in sales.

現在來談談我們的全年業績。以固定匯率計算，淨銷售額成長了 11.3%，達到 411 億歐元，這得益於我們推出的新產品，包括成為轟動一時的 Beyfortus 以及超出我們 130 億歐元銷售目標的 Dupixent。

Gross profit grew by 10.3% at constant exchange rate to EUR31.1 billion with a gross margin of 75.7%. Our gross margin declined slightly due to the absence of any COVID revenue in 2024 and the remaining impact of the Obaggio LOE. R&D expenses increased by 14.6% at constant exchange rates to EUR7.4 billion fully in line with our ambition to step up investments in our pipeline in 2024. SG&A expenses increased by 4.5%, providing an attractive gross leverage benefit. Business EPS increased by 4.1% at constant exchange rates to EUR7.12 exceeding our full year guidance.

以固定匯率計算，毛利成長 10.3% 至 311 億歐元，毛利率為 75.7%。由於 2024 年沒有任何 COVID 收入以及 Obaggio LOE 的剩餘影響，我們的毛利率略有下降。以固定匯率計算，研發費用成長了 14.6%，達到 74 億歐元，這完全符合我們在 2024 年加大對產品線投資的宏偉目標。銷售、一般及行政開支增加了 4.5%，提供了相當吸引人的總槓桿效益。以固定匯率計算，業務每股收益成長 4.1% 至 7.12 歐元，超過了我們的全年預期。

We landed our 2024 business EPS more than 6 percentage points above our initial guidance at the beginning of the year. These results reflect our ability to drive strong growth while investing for the future and while carefully managing our cost base at the same time.

我們 2024 年的每股盈餘比年初的初步預期高出 6 個百分點以上。這些結果反映了我們在投資未來和謹慎管理成本基礎的同時推動強勁成長的能力。

Looking ahead to 2025, we would like to provide an overview of anticipated key business dynamics, which may be helpful for modeling purposes. As a reminder, at the beginning of the year, we expect to see the usual impact from the annual reset of insurance deductibles, which leads to higher utilization of our co-pay assistance program for specialty medicines in the US Market.

展望 2025 年，我們想概述預期的關鍵業務動態，這可能有助於建模目的。提醒一下，在年初，我們預計將看到年度保險免賠額重置的通常影響，這將導致我們在美國市場針對專科藥物的共同支付援助計劃的利用率更高。

We anticipate only modest headwinds from the introduction of changes to Medicare Part D under the IRA. We continue to simplify our portfolio of other medicines, and we expect around EUR250 million of sales reduction from disposals. We expect Beyfortus to grow further with additional penetration on geographic expansion. Our gross margin is expected to increase in 2025.

我們預計，IRA 項下 Medicare Part D 的變更只會帶來輕微的阻力。我們繼續簡化其他藥品的組合，預計處置將造成約2.5億歐元的銷售減少。我們預計，隨著地理擴張的進一步滲透，Beyfortus 將實現進一步成長。我們的毛利率預計在 2025 年將會增加。

R&D expenses will be slightly up, and there was a one off Sobe item last year. SG&A will also slightly increase in preparation for upcoming launches, and we expect capital gains from portfolio simplifications to be again around EUR500 million. Our effective tax rate should remain broadly stable compared to 2024.

研發費用會略有增加，去年有一次性的Sobe項目。為了準備即將推出的產品，銷售、一般及行政開支也將略有增加，我們預計投資組合簡化帶來的資本利得將再次達到 5 億歐元左右。與 2024 年相比，我們的有效稅率應保持大致穩定。

For our 2025 guidance, we have decided to expand our disclosure by providing sales growth in addition to EPS growth. For 2025, we project sales to grow at the mid- to high single digit percentage at constant exchange rates. This guidance now excludes any impact from hyperinflation, which accounted for about 1.8 percentage point of sales growth in 2024.

對於我們的 2025 年指引，我們決定擴大揭露範圍，除了每股收益成長外，還提供銷售額成長。預計到 2025 年，以固定匯率計算，銷售額將以中高個位數百分比成長。該指引目前已排除惡性通貨膨脹的影響，惡性通貨膨脹約佔 2024 年銷售成長的 1.8 個百分點。

We estimate a positive foreign exchange impact on sales of approximately plus 2% to 3% in 2025. Business EPS growth is expected to grow at a low double-digit percentage at constant exchange rates before foreign exchange and before share buyback impacts. We estimate a positive business EPS impact from currency of approximately plus 2% to 3% as well. Shifting to our free cash flow in 2024, which was mainly impacted by 3 one offs: first, the impact of price cuts of Lantus in the US.

我們預計，2025 年外匯將對銷售額產生約 2% 至 3% 的正面影響。在考慮外匯和股票回購影響之前，以固定匯率計算，預計企業每股盈餘將以低兩位數百分比成長。我們預期貨幣政策將對企業每股盈餘產生約 2% 至 3% 的正面影響。轉向我們 2024 年的自由現金流，主要受到三個一次性因素的影響：首先，美國 Lantus 降價的影響。

In H1 for EUR1.1 billion second, the entire elimination of all factoring of receivables for EUR1.4 billion and third, an unfavorable exchange rate impact of EUR0.8 billion all of it resulting in a closing free cash flow of EUR6 billion. We expect our free cash flow ratio to be back to our historical levels steadily over 2025 and 2026. The slight increase of our net debt at the end of 2024 reflects our strategic investments, including the acquisition of INBREAKS as well as our value proposition to shareholders in the form of a growing dividend.

上半年的自由現金流為 11 億歐元；其次，完全消除了 14 億歐元的所有應收帳款保理；第三，不利的匯率影響為 8 億歐元，所有這些導致期末自由現金流為 60 億歐元。我們預計我們的自由現金流比率將在 2025 年和 2026 年穩步回到歷史水準。2024 年底我們的淨債務略有增加，反映了我們的策略投資，包括對 INBREAKS 的收購，以及以不斷增長的股息形式向股東提供的價值主張。

Our net debt to EBITDA ratio, which is actually pretty close to our net debt to BOI ratio, was at 0.7 times at the end of 2024. This showcases a low gearing ratio and an optimal balance between strategic capital allocation and financial flexibility. In 2025, Sanofi will receive a cash consideration in the high single digit in billions of Euros from the Opela transaction at the earliest in Q2 while retaining a significant stake in the company above 48%.

我們的淨負債與 EBITDA 比率實際上非常接近我們的淨負債與 BOI 比率，截至 2024 年底為 0.7 倍。這表明負債率較低，戰略資本配置與財務靈活性之間達到了最佳平衡。2025年，賽諾菲最快將於第二季從歐佩拉交易中獲得數十億歐元的現金對價，同時仍持有該公司48%以上的股份。

Let me conclude by confirming our existing capital allocation policy. Our primary focus is to invest in our business to drive growth, demonstrated by our increased investment in R&D last year as well as ongoing investments in manufacturing, in AI, in digitalization as well as in sales and marketing.

最後，我想確認一下我們現有的資本配置政策。我們的主要重點是投資我們的業務以推動成長，這體現在我們去年對研發的投資增加以及對製造、人工智慧、數位化以及銷售和行銷的持續投資。

We will continue to explore external growth opportunities to strengthen our four existing therapeutic areas and potentially cover white spaces. In all our external investments, we maintain strict discipline and focus on value creation for our shareholders. Our preference remains for investments in the range of EUR2 billion to EUR5 billion each. We are committed to maintaining our AA credit rating in the short to medium term.

我們將繼續探索外部成長機會，以加強我們現有的四個治療領域並可能涵蓋空白領域。在我們所有的外部投資中，我們都保持嚴格的紀律並專注於為股東創造價值。我們仍然傾向於投資20億歐元至50億歐元。我們致力於在短期至中期內維持我們的 AA 信用評級。

In line with our commitments to shareholders, Sanofi intends to execute a share buyback program of EUR5 billion in 2025. These repurchases will be conducted preferably through block trades and in the open market. Shares acquired will be canceled and will have an accretive effect to Sanofi's earning per share, mitigating part of the Opela dilution. This commitment underscores our confidence in Sanofi's future and our commitment to delivering long term shareholder value.

根據對股東的承諾，賽諾菲計劃在 2025 年實施 50 億歐元的股票回購計畫。這些回購將最好透過大宗交易和公開市場進行。所收購的股份將被取消，並將對賽諾菲的每股收益產生增值效應，從而減輕部分歐佩拉的稀釋。這項承諾彰顯了我們對賽諾菲未來的信心以及我們對實現長期股東價值的承諾。

Our proposed dividend of EUR3.92 per share for 2024 marks the 30th consecutive year of dividend increase, further reflecting the emphasis we put on shareholder reward and the dependability of our dividend policy. With the proposed dividend and the share buyback combined, we will reward shareholders with almost EUR10 billion in 2025. This would be a record year in terms of shareholder return for Sanofi.

我們計劃在 2024 年派發每股 3.92 歐元的股息，這是股息連續第 30 年增加，進一步反映了我們對股東回報的重視以及股息政策的可靠性。加上擬議的股息和股票回購，我們將在 2025 年為股東帶來近 100 億歐元的回報。就股東回報而言，這將是賽諾菲創紀錄的一年。

I now hand over to Uman to provide an update on the progress of our innovation pipeline.

現在我把時間交給烏曼，讓他報告我們創新管道的進展。

Thank you, Francois. 2024 accelerated the transition into a company with increased focus on science with our pipeline starting to deliver meaningful benefits for patients and healthcare systems and growth opportunities for our company. We presented convincing clinical trial results, recent medical meetings, including tolebrutinib in SBMS, rilzabrutinib in ITP and fitusiran in hemophilia.

謝謝你，弗朗索瓦。 2024年，我們加速轉型為一家更重視科學的公司，我們的產品線開始為病患和醫療保健系統帶來有意義的利益，並為公司帶來成長機會。我們在最近的醫學會議上展示了令人信服的臨床試驗結果，包括SBMS 中的托萊替尼、ITP 中的利扎替尼和血友病中的 fitusiran。

The molecules from our pipeline that we are incidentally preparing for launch this year. As we look holistically at R&D productivity, scientific publications in high impact journals underpin our commitment to developing science and bringing new medicines and treatments to patients.

我們正準備在今年推出來自我們管道的分子。當我們全面審視研發生產力時，高影響力期刊上的科學出版物鞏固了我們致力於發展科學以及為患者帶來新藥物和新療法的承諾。

We have an increasing trend of high impact publications, and we now plan to closely track this leading indicator of improved productivity over time. Our pipeline has continued to deliver positive results including eight positive Phase 3 readouts in 2024.

我們的高影響力出版物呈現不斷增加的趨勢，現在我們計劃密切追蹤這個隨著時間推移提高生產力的領先指標。我們的研發管線持續取得正面成果，包括 2024 年第 3 階段的 8 個正面讀數。

We've initiated 18 mid to late-stage studies with seven Phase 3s and six new molecular entities moving into the clinic. This increased level of activity is the main driver of R&D spend that Francois covered earlier. On the regulatory side, we've made substantial progress with 21 acceptances of our regulatory submissions, including for the three new molecules for this year.

我們已經啟動 18 項中後期研究，其中 7 項處於 3 期研究，6 項新分子實體進入臨床。活動水準的提高是 Francois 先前提到的研發支出的主要驅動力。在監管方面，我們取得了實質進展，已有 21 份監管申請獲得接受，其中包括今年的三種新分子。

Some of these are benefiting from priority review. We received 14 approvals supporting the ongoing new launch. Please turn to the next slide. We are pleased with the significant progress made for SARCLISA in 2024, including approvals of the IMROL study in the US.

其中一些正受益於優先審查。我們已獲得 14 項批准，以支援正在進行的新產品發布。請翻到下一張投影片。我們對 SARCLISA 在 2024 年取得的重大進展感到高興，包括美國批准 IMROL 研究。

And EU last week. During the ASH meeting, data were presented in the frontline treatment option in multiple myeloma, both for patients eligible and ineligible for autologous stem cell transplant. On the left, we have the PFS curve from the HD7 study where SARCLISA added to a standard frontline combination demonstrated a 43% improvement in PFS based on a hazard ratio of 0.7. We're very pleased that SARCLISA continues to shine in terms of patient benefits by offering a new standard of care. On the right, we reference the iRACLEA Phase 3 study of subcutaneous SARCLISA meeting both co-primaries, non-inferiority endpoints in addition to confirming a safety profile.

還有上週的歐盟。在 ASH 會議期間，針對適合和不適合自體幹細胞移植的患者，展示了多發性骨髓瘤一線治療方案的數據。左側是 HD7 研究中的 PFS 曲線，其中 SARCLISA 添加到標準一線組合中，基於 0.7 的風險比，顯示 PFS 提高了 43%。我們非常高興 SARCLISA 透過提供新的​​護理標準在患者利益方面繼續大放異彩。在右側，我們參考了 iRACLEA 第 3 階段皮下 SARCLISA 研究，該研究除了確認安全性之外，還滿足共同主要終點、非劣效終點。

Additional data from ongoing studies in combination with different standards of care and across multiple lines of treatment will support a broad application for subcutaneous administration which we think will bring new benefits to patients in healthcare systems. The first regulatory submission is expected in the first half of 2025.

正在進行的研究結合不同的護理標準和多種治療方法獲得的額外數據將支持皮下給藥的廣泛應用，我們認為這將為醫療保健系統中的患者帶來新的好處。預計第一次監管提交將在 2025 年上半年進行。

On slide 21, our commitment to rare diseases remains steadfast. Rilzabrutinib is one of the new additions to this portfolio with potential in ITP and far beyond. At ASH, we shared the Phase 3 data in ITP with rilzabrutinib being its primary endpoint of a durable response in 23% of patients compared to 0% on placebo at week 25.

在第 21 張投影片上，我們對罕見疾病的承諾依然堅定不移。Rilzabrutinib 是該產品組合的新產品之一，在 ITP 及其他領域具有巨大潛力。在 ASH 上，我們分享了 ITP 的 3 期數據，其中利扎布替尼是其主要終點，即在第 25 週，23% 的患者出現持久反應，而使用安慰劑的患者比例為 0%。

In addition, a platelet response defined as a platelet count achieving at least 50 by 10 to 9 liter or a platelet count between 30 by 10 to 9 per liter and 50 by 10 to 9 per liter that double from baseline was achieved in 65% of our patients after only 15 days of treatment.

此外，僅經過 15 天的治療，65% 的患者就達到了血小板反應，其定義為血小板計數達到至少 50 x 10-9 公升，或血小板計數在每公升 30 x 10-9 至 50 x 10-9 之間，比基線增加一倍。

As rilzabrutinib pleiotropically addresses the underlying immunological mechanisms of the disease instead of just boosting platelets per se, as some existing medicines do, it confers an improvement in the quality of life of clinical symptoms and fatigue even in non durable response. We anticipate global approvals this year and launch as regulatory reviews are ongoing in EU, China and in the US. With the PDUFA date of 29th August.

由於利扎布替尼多效性地解決了疾病的潛在免疫機制，而不是像一些現有藥物那樣僅增加血小板本身，因此即使在非持久反應中它也可以改善臨床症狀和疲勞的生活品質。我們預計今年將獲得全球批准，並在歐盟、中國和美國的監管審查正在進行時推出。PDUFA 日期為 8 月 29 日。

In addition, we now have meaningful benefit in wAIHA IgG4-related disease from our Phase 2 programs with IgG4 being shared for the first time today. We're evaluating the move into Phase 3 with at least one of these two indications. As we remain committed to rare disease, we believe rilzabrutinib can bring significant patient benefit as we unleash the potential of pleiotropic immune modulation.

此外，我們現在從第 2 階段計劃中獲得了對 wAIHA IgG4 相關疾病有意義的益處，並且今天首次共享 IgG4。我們正在根據上述兩個跡像中的至少一個來評估是否進入第三階段。由於我們始終致力於罕見疾病研究，我們相信，隨著我們釋放多效免疫調節的潛力，rilzabrutinib 可以為患者帶來顯著的益處。

On slide 22, our partner Teva recently announced positive Duvakitug Phase 2b results in IBD. IBD remains an important unmet medical need in immunology where we are underrepresented today. DIVATICU represents a meaningful opportunity for Sanofi to begin to bring new science and benefit to IBD patients, continuing immunology and far beyond. We saw statistically significant and clinically meaningful benefits in ulcerative colitis and Crohn's disease with all endpoints met and faring pleasingly competitively within the TL1a class. It is the first and only TL1a to demonstrate benefit in Crohn's disease.

在幻燈片 22 上，我們的合作夥伴 Teva 最近宣布了 Duvakitug 第 2b 期 IBD 的正面結果。IBD 仍然是免疫學領域一個尚未滿足的重要醫療需求，而我們目前對此的關注還不夠。DIVATICU 為賽諾菲提供了一個有意義的機會，使其能夠開始為 IBD 患者帶來新的科學和益處，延續免疫學研究並拓展其應用範圍。我們看到了潰瘍性結腸炎和克羅恩病方面具有統計學和臨床意義的益處，所有終點均已滿足，並且在 TL1a 類中表現出令人滿意的競爭力。它是第一個也是唯一一個被證明對克隆氏症有益的 TL1a。

Patients achieved strong placebo adjusted responses across both indications as high as 27.4% clinical remission in UC and 34.8% endoscopic response in Crohn's disease, both at the high dose level tested. Combined with a favorable safety and tolerability profile, these positive results offer an opportunity to advance the program into Phase 3 development and potentially offer an improved outlook for patients with moderate to severe inflammatory bowel disease relatively soon.

在所測試的高劑量水平下，患者在兩種適應症中均獲得了強烈的安慰劑調整反應，潰瘍性結腸炎的臨床緩解率高達 27.4%，克隆氏症的內視鏡反應率高達 34.8%。結合良好的安全性和耐受性，這些積極結果為該計畫推進到第 3 階段開發提供了機會，並可能相對較快地為中度至重度發炎性腸道疾病患者提供改善的前景。

Additionally, data will be presented at the ECHO meeting later this month. I'd like to conclude with my usual news flow slide now with 2026 news flow for the first time. We plan 12 Phase 3 readouts, 15 regulatory submissions and 13 regulatory decisions in multiple jurisdictions increasingly capturing the improving value of our clients. Importantly, we also see the intensity of the news flow increase over the coming two years, building on our earlier comment about our focus on improving R&D productivity. The cadence and the volume of the R&D drumbeat continue to quicken.

此外，數據將於本月稍後在 ECHO 會議上公佈。我想用我通常的新聞流幻燈片來結束這次演講，這是我第一次用 2026 年的新聞流來結束演講。我們計劃在多個司法管轄區進行 12 次第 3 階段讀數、15 次監管提交和 13 項監管決策，以持續提高客戶的價值。重要的是，我們也看到未來兩年新聞流的強度將會增加，這基於我們先前關於重點提高研發產量率的評論。研發鼓點的節奏和音量不斷加快。

We look forward to updating you on our progress. As I regularly say, we remain humble in the face of disease and regrettably not everything will work. However, I'm optimistic that the impact of talented science focused teams coupled our increasing exposure to breathtaking digital technologies will drive this unique pipeline in our core focus therapy areas in the service of patients. I would like to thank all of my brilliant R&D team members and colleagues across the company for the positive progress made this year. We are indeed chasing the miracles of science to improve people's lives.

我們期待向您通報我們的進展。正如我常說的那樣，面對疾病我們仍需保持謙卑，遺憾的是並非所有疾病都能奏效。然而，我樂觀地認為，專注於科學的才華橫溢的團隊的影響，加上我們對令人驚嘆的數位技術的日益接觸，將推動我們在核心重點治療領域的獨特管道，為患者服務。我要感謝所有優秀的研發團隊成員和公司上下的同事，感謝他們今年的正面進展。我們確實在追求科學奇蹟以改善人們的生活。

With this, I hand back to Paul for Q&A.

說完這些，我將問題交還給保羅。

Well, thank you, Houman. Thank you, Francois. We'll now call to your questions. As a reminder, we'd ask you to limit your questions to one or two each. I said this every time everybody hears that part.

好吧，謝謝你，Houman。謝謝你，弗朗索瓦。我們現在就來回答您的問題。提醒一下，我們要求您將每個問題限制為一到兩個。每次大家聽到這部分時我都會這麼說。

You'll be notified when your line is open to ask your question at that time. Please make sure you unmute your microphone or option to submit a question by clicking the Q&A icon at the bottom of the screen. Your question will be read by our panelists. Now we'll take the first question, please.

當您的線路開放以便您提出問題時，您將收到通知。請確保您取消麥克風靜音，或點擊螢幕底部的問答圖示選擇提交問題。我們的小組成員將會閱讀您的問題。現在我們來回答第一個問題。

Luisa Hector, Berenberg.

路易莎·赫克托（Luisa Hector），貝倫貝格。

Hi there. Thanks for taking my question. On the buyback, perhaps you could just comment on the rationale for the size, the EUR5 billion and how soon you might start the buyback? And then any color on plans for the rest of your proceeds? So essentially, just latest thoughts on M&A targets by development stage, therapy area, size, et cetera.

你好呀。感謝您回答我的問題。關於回購，您是否可以評論一下回購規模（50 億歐元）的理由，以及您將在多久後開始回購？那麼，您對剩餘收益有何規劃呢？因此，本質上，只是按發展階段、治療領域、規模等對併購目標的最新想法。

Perhaps then I could move to vaccines. I would like to ask some questions, maybe on the pneumococcal vaccine. So the Phase 3 entry, very exciting. Perhaps a bit more color on what you're looking to show in Phase 3 and how you see the competitive landscape because there are others coming forward with vaccines perhaps with higher valency, 24, 31. So how you see a 21 valent vaccine fitting in? Thank you.

或許到那時我就可以開始接種疫苗了。我想問一些問題，也許是關於肺炎鏈球菌疫苗的。因此進入第三階段，非常令人興奮。也許您可以更詳細地介紹您希望在第 3 階段展示的內容以及您如何看待競爭格局，因為其他公司正在研發疫苗，也許效力更高，24、31。那麼您認為 21 價疫苗適合嗎？謝謝。

Thank you, Luisa. I counted eight questions. So okay. So buyback, sizing, timing, proceeds, over to you, Francois.

謝謝你，路易莎。我數了一下，一共有八個問題。好吧。因此，回購、規模、時機、收益都交給你了，弗朗索瓦。

Yes. Good morning, Louisa. See, the rationale for the EUR5 billion actually, we wanted to mitigate part of the dilution of Opelas. So I think that we are addressing that with the EUR5 billion. What we did as well was to listen to you as analysts and to listen as shareholders as well. And we found that EUR5 billion was actually the amount that on which there was a consensus as well on your side.

是的。早安，路易莎。其實，50 億歐元的理由是，我們想減輕 Opelas 的部分稀釋。所以我認為我們將以 50 億歐元來解決這個問題。我們也所做的就是聽取你們身為分析師的意見，也聽取你們身為股東的意見。我們發現，50 億歐元其實是你們一致同意的金額。

The starting point, we expect to start the share buyback in the middle of next week actually or relatively quickly. The rest of the proceeds, it's part of our capital allocation. You saw that first and foremost, we want to invest in our business, which is what we did in R&D last year, which is what we do as well on a permanent basis in AI, in manufacturing.

起點是，我們預計下周中旬實際上或相對較快地開始股票回購。其餘收益是我們資本配置的一部分。您看到，首先，我們希望投資我們的業務，這就是我們去年在研發方面所做的，也是我們在人工智慧和製造業領域長期所做的。

There will be more coming in, in sales and marketing ahead of quite a few launches coming in. Obviously, we are looking as well very seriously at external growth opportunities, BD and M and A, without any pressure because we have a strong growth outlook ahead of us, because we have a strong pipeline as well.

在推出大量新產品之前，還會有更多銷售和行銷方面的投入。顯然，我們也在非常認真地考慮外部成長機會，BD 和 M 和 A，沒有任何壓力，因為我們擁有強勁的成長前景，因為我們也有強大的管道。

I mean, Houman just covered it a few minutes ago. That being said, we have a strong balance sheet. As you could see, we have a limited amount of debt as at the end of 2024, so which gives us a certain number of opportunities. But we don't feel any pressure to go crazy on M&A and BD. So we will remain very disciplined while having the opportunity to complement whatever we have in our pipeline.

我的意思是，Houman 幾分鐘前剛剛報道這個事情。話雖如此，我們的資產負債表仍然強勁。正如您所看到的，截至 2024 年底，我們的債務有限，這為我們提供了一定的機會。但我們並沒有感受到在併購和 BD 上瘋狂的壓力。因此，我們將保持高度自律，同時有機會補充我們現有的任何產品。

So the main focus will be essentially on our four therapeutic areas, which you know, plus potentially some white splices, once again, without feeling any pressure and always focused on creating value for our shareholders.

因此，主要重點將放在我們的四個治療領域，再加上可能的一些白色拼接，再一次，我們不會感受到任何壓力，並且始終專注於為我們的股東創造價值。

Thank you. Thomas, PCV21 competitive landscape?

謝謝。湯瑪斯，PCV21的競爭格局？

Thank you, Luisa. Indeed, Sanofi was very pleased to announce the start of the Phase 3 program for our PCV21 panel product. The study is progressing as per plan. And in total, we are expecting to include more than 7,000 infants into the overall Phase 3 program. More broadly and in line with the question, as you know very well, first of all, it's exactly at the heart of what we're doing today at Sanofi vaccines.

謝謝你，路易莎。事實上，賽諾菲非常高興地宣布我們的 PCV21 面板產品的第三階段計劃已啟動。該研究正在按計劃進行。總的來說，我們預計整個第三階段計劃將納入超過 7,000 名嬰兒。更廣泛地說，與這個問題相符的是，正如您所知，首先，這正是我們今天在賽諾菲疫苗領域所做工作的核心。

It's reaching either the pediatric for this Phase 3 program or the elderly segments, both segments where we are very well positioned. So it fits perfectly with our portfolio. It will be nicely complementary. It's a big space today, but pediatric is about 70% of the normal business altogether. And basically, as per the competitiveness of the program, I think I have a couple of things to highlight.

該藥物要麼覆蓋第三階段計畫的兒科患者，要麼覆蓋老年患者，在這兩個領域我們都佔據著非常有利的地位。所以它與我們的投資組合非常契合。這將是很好的補充。如今，兒科醫療市場空間很大，但兒科醫療約佔正常業務總量的 70%。基本上，就該專案的競爭力而言，我認為有幾件事需要強調。

First of all, PCV21 program is going to be the first pediatric vaccines against pneumococcal disease that we enter into a national immunization schedule, The first one with more than 20 valences. So I think that we position well as a starting point. As you've noticed also from our December announcement, we've announced a refocusing of the alliance with our partner SK, which means that it's a starting point. It's not an ending point. We'll start with PCV21.

首先，PCV21計畫將成為我們納入國家免疫計畫的首個兒童肺炎鏈球菌疫苗，也是第一個價數超過20種的疫苗。因此我認為我們的定位是一個很好的起點。正如您從我們 12 月的公告中註意到的那樣，我們已宣布重新調整與合作夥伴 SK 的聯盟，這意味著這是一個起點。這不是一個終點。我們將從 PCV21 開始。

And of course, our objective is to be competitive all over the marketplace. Therefore, we'll keep going forward with more and more balances. So we appreciate, obviously, that other companies are working on other candidates in this space, but we do believe that we are very well positioned to start a significant entry into that place, and we remain competitive in the future.

當然，我們的目標是在整個市場上保持競爭力。因此，我們將繼續努力，實現更多的平衡。因此，我們顯然很欣賞其他公司正在研究該領域的其他候選產品，但我們確實相信，我們完全有能力開始進入該領域，並且我們在未來仍將保持競爭力。

Great. That's it. The first is you said 21, or 21 valences and a couple of years ahead in the pediatric market, which is the biggest segment of all in that market. Okay, next question?

偉大的。就是這樣。首先，您說的是 21，或 21 種價態，以及在兒科市場領先幾年，而兒科市場是該市場中最大的細分市場。好的，下一個問題？

Graham Parry, BofA.

美國銀行的 Graham Parry。

Thanks for taking my questions. So firstly, on Dupixent and just the gross to net adjustment in the Q4. Can you just clarify that was just a one-off adjustment catch up for channel mix rebate levels through the whole year of 2025? And just the extent to which that drove the EUR150 million miss, is that just the majority of that compared to, say, invoicing days? And then just any comments you've got on how that could progress into 2025?

感謝您回答我的問題。首先，關於 Dupixent 以及第四季的毛利與淨利調整。您能否澄清一下，這只是對 2025 年全年通路組合折扣水準的一次性調整？那麼這在多大程度上導致了 1.5 億歐元的損失，與發票天數相比，這是否只是其中的大部分？那麼，您對這一進程到 2025 年將如何發展有什麼評論嗎？

And then secondly, on Beyfortus, just given clesrovimab potential for approval this year, possible inclusion in the season, do you are you what are you assuming in your guidance for the year on Beyfortus? Is it expected to grow? And then finally on tolebrutinib, if you could just update us on the indication that you're expecting for tolebrutinib in non-relapsing SPMS. Is it classically defined non relapsing SPMS you're discussing? Or is there any potential here to get a broader label for progression independent of relapse activity? Thank you.

其次，關於 Beyfortus，鑑於 clesrovimab 有可能在今年獲得批准，並可能納入本季度，您對 Beyfortus 年度指導有何假設？預計會成長嗎？最後關於托布替尼，您能否向我們更新您預期托布替尼在非復發性 SPMS 中的應用情況。您正在討論的是經典定義的非復發性 SPMS 嗎？或者是否有可能獲得一個與復發活動無關的更廣泛的進展標籤？謝謝。

Thank you. Graham, Brian, DP growth to net and outlook to '25.

謝謝。格雷厄姆 (Graham)、布萊恩 (Brian)、DP 淨值成長和 25 年展望。

Yeah. Thanks so much, Graham, for the question. And I'll first start off by reiterating what Paul said in his opening remarks. We couldn't be more pleased with Dupixent's full year performance delivering greater than EUR13 billion. As you guys know, we provided the target of EUR13 billion for the year, 23% growth this previous year. And again, it's underlying demand driven is what's happening here. So we have strong TRx growth across indications and across geographies. And that's the same actually for Q4.

是的。非常感謝 Graham 提出這個問題。首先，我想重申保羅在開場白中所說的話。Dupixent 全年業績超過 130 億歐元，我們對此感到非常滿意。大家知道，我們今年的目標是 130 億歐元，比去年成長 23%。再次強調，這裡發生的事情是由潛在的需求所驅動的。因此，我們的 TRx 在各個適應症和地理區域都實現了強勁成長。事實上，第四季的情況也是一樣的。

Q4 was really strong performance with double digit growth in terms of sales and TRxs. And it's just exactly as you said, I think you said it in your question, it was really due to the Q4 net sales reflect some one-off items in the US, so there's some true ups there.

第四季表現非常強勁，銷售額和 TRxs 均實現了兩位數的成長。正如您所說，我想您在問題中也提到了這一點，這實際上是由於第四季度的淨銷售額反映了美國的一些一次性項目，因此確實存在一些上升。

And of course, there is a little bit of the fewer business days. There's a little bit of each of the two mixes. But overall, again, really this doesn't affect volume. We're in a really strong position as far as volume goes. And now having 2024 behind us, it even further reinforces our commitment to our longer-term guidance that we provided. So feel like we're in a very good shape exiting '24 and entering '25.

當然，工作日也會稍微少一點。兩種混合物各有一點。但總體而言，這確實不會影響音量。就銷量而言，我們處於非常有利的地位。如今 2024 年已經過去，這進一步加強了我們對所提供的長期指導的承諾。因此感覺我們在退出24年和進入25年時的狀態非常好。

And you see the script trends as we started the year, so very encouraging already. Beyfortus guidance, Tom, on competitive set?

如您所見，今年年初的劇本趨勢已經非常令人鼓舞。湯姆，Beyfortus 指導有關競爭嗎？

Yeah. So thanks for the question, Graeme. First of all, maybe before we switch on to 2025, a couple of those on 2024, very happy about the first year of Beyfortus, first full year of sales. We reached close to EUR1.7 billion unprecedented pediatric immunization launch in the history of pediatric immunization. So I think that's a proof point of our capabilities.

是的。謝謝你的提問，格雷姆。首先，也許在我們進入 2025 年之前，其中有幾個是關於 2024 年的，我們對 Beyfortus 的第一年、第一個完整銷售年感到非常高興。我們達成了近17億歐元的兒科免疫接種計劃，這是兒科免疫接種歷史上前所未有的。所以我認為這是我們能力的證明。

Now it's also a proof point of the capability of the product because you've seen that not only, we are happy about the sales but most importantly we are very happy about the impact we have seen on hospitalization in the newborn population.

現在這也是該產品能力的證明點，因為您已經看到，我們不僅對銷售感到滿意，而且最重要的是，我們對它對新生兒住院率的影響感到非常高興。

Now moving forward from 2024 to 2025, we see further growth in 2025. That's very clear when you look at the penetration on the number of countries we can go to. There's more penetration in some markets and there's a couple of more markets notably in Europe or Asia where we could grow in the coming year in 2025 and after in 2026. So obviously, we also recognize that there are more competition coming down the road.

現在從 2024 年展望到 2025 年，我們看到 2025 年將進一步成長。當你看到我們可以去的國家數量的滲透率時，這一點就非常明顯了。在某些市場，我們的滲透率更高，尤其是歐洲或亞洲等幾個市場，我們可以在 2025 年和 2026 年成長。顯然，我們也意識到未來的競爭將會更加激烈。

You've pointed another molecule antibody that could come in 2025. We expect this other molecule antibody to come in 2025 in the US. As we discussed before, I think first impact would be the fact that we will talk more about the importance of RSV prevention. So it will raise the importance of the awareness of RSV disease.

您指出了另一種可能在 2025 年出現的分子抗體。我們預計這種分子抗體將於 2025 年在美國上市。正如我們之前討論過的，我認為第一個影響是我們將更多地談論 RSV 預防的重要性。因此這將提高人們對 RSV 疾病的認識的重要性。

That's the first thing. And then of course, while there will be more competition down the road, we believe that we have a competitive profile with nirsevimab. We have an extensive amount of reward dividends. You've seen many countries showing 80% or 90% reduction in hospitalization. And you've seen the very pristine safety on a large scale that is provided with the Beyfortus moving forward.

這是第一件事。當然，雖然未來會有更多的競爭，但我們相信我們與 nirsevimab 具有競爭力。我們有大量的獎勵紅利。你已經看到許多國家的住院率減少了 80％ 或 90％。而且您已經看到了 Beyfortus 向前發展所提供的大規模極其純粹的安全性。

So I think that from the very broad evidence, from the competitive profile, but we have also with a significant half-life compared to the other molecular antibody, we are well positioned to grow in 2025.

因此，我認為，從非常廣泛的證據和競爭狀況來看，而且與其他分子抗體相比，我們的半衰期也更長，我們完全有能力在 2025 年成長。

Thank you, Thomas. Houman, tolebrutinib and potential label?

謝謝你，托馬斯。Houman、tolebrutinib 和潛在標籤？

Yeah. So thanks for the question, Graham. Tolebrutinib has been submitted in line with our previous guidance last year we're excited about the data for tolebrutinib as you suggested secondly progressive MS and we are equally excited about the readout later in this year for PPMS. This is a demonstration of Sanofi's commitment unwavering commitment to patients that ask.

是的。謝謝你的提問，格雷厄姆。托布替尼已根據我們去年的指導意見提交，我們對托布替尼的數據感到非常興奮，因為您建議使用第二種進展型 MS，我們對今年稍後 PPMS 的讀數也同樣感到興奮。這體現了賽諾菲對患者堅定不移的承諾。

Okay. Next question.

好的。下一個問題。

Seamus Fernandez, Guggenheim.

古根漢的謝默斯·費爾南德斯。

Hello, thanks very much. I'll just go simple and try to abide by the one question request. So actually, the question is for Paul and Houman, sort of simultaneously, if you each wouldn't mind offering up the catalyst that you're most excited about in 2025 in particular.

你好，非常感謝。我會簡單地嘗試並遵守一個問題的要求。所以實際上，這個問題是同時問給 Paul 和 Houman 的，如果你們不介意的話，請提出你們對 2025 年最為興奮的催化劑。

I think most investors anticipate the results of itepekimab most eagerly but love to just kind of hear your thoughts on maybe your top 3. And if perhaps they might differ slightly, it would be fun to hear that as well. Thanks so much.

我認為大多數投資者都熱切地期待 itepekimab 的結果，但也希望聽聽您對前 3 名的看法。如果它們可能略有不同，那麼聽到這些也會很有趣。非常感謝。

All right. So the old, which is your favorite child. For me, it's the one that called me most recently, given things for -- maybe Houman, you start now.

好的。那麼老，哪一個就是你最愛的孩子。對我來說，這是最近打電話給我的人，給了我一些東西——也許 Houman，你現在就開始吧。

Yeah. So I'll be very quick, top 3. I think we're excited about the launch of GP in COPD, which my beloved colleague Brian has already talked about. I think bringing itepekimab alongside that for patients with who are former smokers will be very exciting and reinforcing our position in pulmonary inflammation and immunology. I think it's an exciting time for amelotilumab as we continue the quickening drumbeat, particularly in disorders like asthma and in hyperadnitis suppressiva.

是的。所以我會很快排名前三。我認為我們對 GP 在 COPD 領域的推出感到非常興奮，我親愛的同事 Brian 已經談到了這一點。我認為將 itepekimab 與該藥物一起用於曾經吸煙的患者將非常令人興奮，並能加強我們在肺部發炎和免疫學方面的地位。我認為對於 amelotilumab 來說這是一個令人興奮的時刻，因為我們將繼續加快步伐，特別是在氣喘和腎上腺功能亢進等疾病領域。

And finally, I'm very excited about the ongoing activity around our and completely internally generated bispecific activity in Lunsekimig. So those are my three, but it would be remiss of me not to comment on our three launches that are coming up.

最後，我對我們在 Lunsekimig 中正在進行的以及完全內部產生的雙特異性活性的活動感到非常興奮。這就是我要說的三件事，但如果我不對即將推出的三項發表會發表評論，那就太失禮了。

I'm excited about all of our Phase 2 programs. Just to give it I think the quality of what we're putting in means that we're more confident what comes out, of course, the normal risks around that. Probably a bit of overlapping with Houman, I mean, the itepekimab COPD, is game changer and former smokers. So I think that is going to be really interesting. And I could pick from three or four other things.

我對我們所有的第二階段計劃都感到很興奮。我認為，我們投入的品質意味著我們對結果更有信心，當然，這也伴隨著正常的風險。可能與 Houman 有點重疊，我的意思是，itepekimab COPD 可以改變遊戲規則並治療前吸煙者。所以我認為這將會非常有趣。我還可以從另外三到四種東西中挑選。

But on the later stage, I think it's primary progressive with tolebrutinib. I think they're all a big deal, and I think we can go a bit deeper into Phase 2s. But it's exciting year for us. No LOEs, mid high single digit growth, strong rebrand in EPS and pipeline catalysts. I mean, that's where we want to go, top line, pipeline.

但在後期，我認為使用托魯替尼治療會導致原發性進展性病變。我認為它們都是一件大事，而且我認為我們可以更深入地探討第二階段。但對我們來說這是令人興奮的一年。無 LOE、中高個位數成長、EPS 和管道催化劑強勁重塑。我的意思是，這就是我們想要去的地方，頂線，管道。

Next question.

下一個問題。

Peter Welford, Jefferies.

傑富瑞 (Jefferies) 的彼得‧韋爾福德 (Peter Welford)。

Hi. Thanks for taking my questions. I hope you hear me. So I'll ask these two. Firstly, just on Beyfortus, can you just comment there on two things both in terms of you said growth for 2025. Can we expect US growth within your assumption for 2025? And what's regarding the is the actual doses that you shipped at the moment in the US, or indeed other markets, have they been used? Or are there still doses at the moment that are outstanding that are presumably likely to be used during the first part of the year as the season continues?

你好。感謝您回答我的問題。我希望你能聽到我的聲音。所以我要問這兩個人。首先，就 Beyfortus 而言，您能否就您所說的 2025 年成長方面的兩件事發表評論。我們能預期 2025 年美國的經濟成長率會達到您的假設嗎？那麼，您目前在美國或其他市場運送的實際劑量是否已經被使用過？或者目前仍有未用完的劑量，隨著季節的延續，這些劑量很可能會在上半年使用？

And then secondly, I just wonder if you can comment on the potential for Luncekimig there. I think our catalyst has been pushed into 2026. Is that does that reflect any changes to the data you're awaiting or any change to the Phase 2? Or is that purely just a timing from the point of view of recruiting and getting sufficient data on board for the decision in ASPR Phase 3? Thank you.

其次，我想知道您是否可以評論一下 Luncekimig 在那裡的潛力。我認為我們的催化劑已經推遲到 2026 年。這是否反映了您正在等待的數據的任何變化或第二階段的任何變化？或者這只是從招募和獲取足夠的數據以便為 ASPR 第 3 階段的決策做出決定的角度來看的一個時機？謝謝。

All right. Peter, thank you. Thomas, on Beyfortus, US growth and doses shipped?

好的。彼得，謝謝你。湯瑪斯，關於 Beyfortus，美國的成長和劑量是否已出貨？

Yeah. We don't -- thanks for the question first, Peter. We don't provide exact number of doses shipped by provider or to each country. But I can still give a bit more color on 2025 versus what I've done in 2024. So I think what's at the heart of your question for 2024 is how did we deliver the growth on 2024?

是的。我們不知道——首先感謝你提出這個問題，彼得。我們不提供由供應商或運往各國的確切劑量。但與我在 2024 年所做的事情相比，我仍然可以對 2025 年做出更多的描述。所以我認為你對 2024 年的問題的核心是我們如何在 2024 年成長？

And what does that mean for how should you think about 2025? So first of all, we had a significant increase in supply in 2024. All the teams have been remarkably working on both sides of the partners to deliver that. That has enabled us to deliver in Q4 2024 enough doses to cover for the 2024 needs and the Q1 2025 needs because as you know very well, RSV is not flu. And therefore, you have babies being born in January and February and some more catch up.

這對於您應該如何看待 2025 年意味著什麼？首先，2024 年我們的供應量大幅增加。所有團隊都與合作夥伴共同努力實現這一目標。這使我們能夠在 2024 年第四季度提供足夠的劑量，以滿足 2024 年的需求和 2025 年第一季的需求，因為正如你們所知，RSV 不是流感。因此，一月和二月會有嬰兒出生，還有一些嬰兒會追上來。

So there will be RSV mutation in January, February March, and we've shipped doses in Q4 2024 for that to happen. So this is what accounted for. I still believe that when it comes to penetration, there is an opportunity to increase in the US in the coming years.

因此，1 月、2 月和 3 月將出現 RSV 變異，為此我們已經在 2024 年第四季運送了劑量。這就是為什麼。我仍然相信，就滲透率而言，未來幾年美國還有機會提高。

Of course, as always, when it comes to VCR, it's year by year progressively. There's a lot going on in the US, as you know very well. So we'll know more in the coming few weeks. But when you look at the profile of the product, we believe that there is a good space for the product moving forward.

當然，一如既往，說到VCR，還是逐年進步的。正如你們所了解的，美國發生了很多事情。因此我們將在接下來的幾週內了解更多。但當你查看產品概況時，我們相信該產品還有良好的發展空間。

Thank you, Thomas. Houman, in Lunsekimig.

謝謝你，托馬斯。Houman，在 Lunsekimig。

Yes. So as I said, thanks for asking the question. We're very proud of Linsekhemig combining the potency of TSLP and IL-13, best in class, first in class, unprecedented molecule or the best pheno data that's out there. Your specific question was about the implication of the move into '27 of that. I just want to I want to take a step back.

是的。正如我所說，感謝您提出這個問題。我們為 Linsekhemig 將 TSLP 和 IL-13 的功效結合起來而感到非常自豪，這是同類產品中最好的、同類產品中第一個、前所未有的分子或最好的表型數據。您的具體問題是關於進入 27 年意味著什麼。我只是想退一步。

I think the Sanofi has adopted a new discipline. This is part of our freedom now. We're an organization that is robust in our use of data and what all we've done, as you can see, by outlining and dimensionalizing our pipeline timing, what we've tried to do is align that beautifully with clinicaltrials.org. That's all we're doing. There is no implication for Linsekumig.

我認為賽諾菲已經採用了一種新的紀律。這是我們現在自由的一部分。我們是一家在資料使用方面非常強大的組織，正如您所看到的，我們所做的一切，透過概述和維度化我們的管道時間安排，我們試圖做的是使其與 clinicaltrials.org 完美地結合。這就是我們所做的一切。這對於 Linsekumig 來說沒有任何影響。

In fact, our commitment both to moderate to severe asthma as well as high risk asthma underlines the importance of this potential molecule to both increase the efficacy ceiling and possibly drive durability. So simple answer to your question, we remain super confident.

事實上，我們對中度至重度氣喘以及高風險氣喘的承諾凸顯了這種潛在分子對提高療效上限和可能提高耐用性的重要性。所以對你的問題的回答很簡單，我們還是非常有信心。

Thank you. It is really actually quite an exciting product given in particular on high-risk asthma. I mean really, I've been in asthma 35 years, and I think this is a real incredible opportunity. Okay, next question.

謝謝。這確實是一種非常令人興奮的產品，特別適用於治療高風險氣喘。我是說真的，我已經患氣喘 35 年了，我認為這真的是一個難得的機會。好的，下一個問題。

Jo Walton, UBS.

瑞銀的喬沃爾頓。

Thank you. Can you hear me?

謝謝。你聽得到我嗎？

Yeah.

是的。

Excellent. Mike, I have two questions, please. Firstly, can I push you a little bit more on vaccines? Perhaps you can give us some idea of what you think the penetration today in relevant infants is in the US and what that would be compared to some other, you know, sort of early pediatric vaccines, just to give us a sense of what the upside for the market there is?

出色的。麥克，我有兩個問題。首先，我可以再向您推廣一些有關疫苗的事情嗎？也許您可以告訴我們一些關於目前美國相關嬰兒的滲透率的情況，以及與其他早期兒科疫苗相比的情況，只是為了讓我們了解那裡的市場優勢是什麼？

And also within vaccines, can you tell us, a bit more about the proportion of your sales that go to, let's say, adolescents, with mandates, because I think people are fearful that whilst everyone is going to be allowed the choice to have a vaccine going forwards, perhaps some of the mandates that really pushed people to vaccination may weaken, anything to do with individual choice, and you do tend to see lower vaccination rates.

另外，在疫苗方面，您能否告訴我們更多關於疫苗銷售額中流向強制要求的青少年的比例，因為我認為人們擔心，雖然從現在起每個人都可以選擇接種疫苗，但一些真正推動人們接種疫苗的強制要求可能會減弱，這與個人選擇有關，而且您確實會看到疫苗接種率下降。

So, I'd like you to discuss that a little bit in more detail, if you could. And could you also just please tell us a little bit more about healthcare reform in the US, your assumption of how much more you're going to have to pay for the Part D for those patients who are in catastrophic cover? And whether you see any offsets in terms of increased volume from lower patient co pays, more adherence, for example, for things like Dupixent in the elderly.

因此，如果可以的話，我希望您能更詳細地討論一下這個問題。您能否也向我們詳細介紹美國醫療改革的情況，您認為對於參加災難保險的患者，需要為 D 部分支付多少費用？以及您是否看到因患者共付額降低或依從性提高（例如，老年人使用 Dupixent 等藥物）而帶來的用量增加等抵消作用。

Okay. Thank you. Francois may go to you on the last part of the assumptions. Some very specific questions, Thomas. I'm not sure that you can answer them specifically, but you can certainly share what you think.

好的。謝謝。弗朗索瓦可能會就假設的最後一部分向你提問。一些非常具體的問題，托馬斯。我不確定你能否具體回答這些問題，但當然可以分享你的想法。

Yeah. And if I cannot answer them specifically, this call. That's why we're having quarterly calls. It might be some other quarters on the road. What I mean by that sorry, Hi, Joe. And back to your first question on the penetration in the US.

是的。如果我無法具體回答，請致電。這就是我們召開季度電話會議的原因。也可能是路上的其他地方。我的意思是抱歉，嗨，喬。回到您關於美國滲透率的第一個問題。

It will be today in January a bit premature because I said before, you have the full data a few weeks after injection. And we know very well that RSV and Musicians are going to go see in January, February March. So it's a bit early to say.

現在應該是一月份，這有點為時過早，因為我之前說過，注射後幾週你就會獲得完整的數據。我們很清楚，RSV 和音樂家將在一月、二月、三月前往演出。所以現在說還太早。

I would expect the significant percentage of the US. Birth cohort has been protected against RSV this year, but which means more than the majority, more than half, if you wish. But it's way too early to be a bit more precise. Wait for a couple of one or two earning calls, and we'll do a bit more.

我預計美國的比例會很大。今年出生的人群已經接受了對呼吸道合胞病毒的預防，但這意味著，如果你願意的話，超過大多數，超過一半。但現在下結論還為時過早。等待一到兩次獲利電話會議，我們還會做更多的事情。

It will give you more idea of further room to play. But there is as for any immunization coming into the market, it takes two or three years to pick in terms of VCR. So I think that's what we should expect for the product, especially the whole category.

它將為您提供更多關於進一步發揮的空間的想法。但對於任何進入市場的免疫疫苗，從 VCR 的角度來看，都需要兩到三年的時間才能成熟。所以我認為我們應該對該產品，特別是整個產品類別抱持這樣的期望。

Now on your second question, which is very different on percentage of adolescents with corresponding to mandated or potentially mandated immunizations in the US, I understand where the question is coming from.

現在回到您的第二個問題，與美國強製或潛在強制免疫接種相對應的青少年比例有很大不同，我明白這個問題的出處。

A bit early there, I would say that if you want to have an idea, the immunizations you're talking about are some boosters in adolescents and some meningococcal shots in adolescents, so mening and boosters. However, if you're looking at the heart of your question, I personally do not believe that mandatory or not monetary situations will make a big difference into the taxation coverage rates. So we are not specifically worried for that.

現在說這個還為時過早，我想說，如果你想有個概念，你談論的免疫接種是青少年的一些加強針和青少年的一些腦膜炎球菌疫苗，所以是腦膜炎和加強針。然而，如果你從問題的核心來看，我個人並不認為強制性或非強制性貨幣條件會對稅收覆蓋率產生很大影響。所以我們並不特別擔心這一點。

Of course, it's something we are monitoring as a field. But when you look at the clear benefits risk of our products moving forward between disease and not disease, those onetime immunizations are very clear in terms of safety and benefits.

當然，這是我們正在監測的一個領域。但是，當您看到我們的產品在疾病和非疾病之間產生的明顯益處和風險時，那些一次性免疫接種在安全性和益處方面是非常明顯的。

So again, there are some decisions that will happen in the coming few months or quarters, maybe. Let's see. Let's not have too many hypotheses. But whether or not monetary situation are removed, I do not foresee today a major impact on ourselves.

所以，有些決定可能在未來幾個月或幾季內做出。讓我們來看看。我們不要有太多的假設。但無論貨幣狀況是否消除，我預計今天不會對我們造成重大影響。

Thank you. Maybe Francois will let you --

謝謝。也許弗朗索瓦會讓你--

On the Medicare Part D, as I said, we expect a modest impact. It has been fully built in our 2025 guidance and budget, obviously. You talked about the volume elasticity. There is very difficult to assess, but we don't expect a significant positive volume elasticity out of it. But maybe I'll let Brian complement what I said.

正如我所說，對於醫療保險 D 部分，我們預計其影響不大。顯然，它已經在我們的 2025 年指導和預算中完全建成。您談到了體積彈性。雖然很難評估，但我們預計不會有顯著的正體積彈性。但也許我會讓布萊恩補充我所說的話。

Yeah. I think as Francois said, we're a little bit less exposed versus some of the other organizations as well based upon the nature of our portfolio. Again, more innovative medicines and vaccines. So you tend to have a little bit less exposure there. As well, you see a lot of our business even for Dupixent, we've said 70% of our business really primarily comes from commercial versus again in the government channels.

是的。我認為，正如弗朗索瓦所說，基於我們投資組合的性質，與其他一些組織相比，我們的風險敞口較小。再次，更多創新藥物和疫苗。因此，你在那裡的曝光率可能會較低一些。同樣，您會看到，即使是 Dupixent，我們的許多業務也主要來自商業管道，而不是政府管道。

But nevertheless, I think, Joe, you hit the nail on the head a little bit. What we haven't seen yet is, will we actually have a little bit of volume improvement based upon the 2,000 annual out of pocket cap for patients which could lead to improved compliance for patients as well. So that's really to be determined, but that could be a potential slight offset if you will, but we feel like we're in a very good position as we enter into 2025.

但儘管如此，我認為，喬，你的意見有點一針見血。我們還沒有看到的是，我們是否真的會在患者每年 2,000 美元的自付上限基礎上稍微提高一些數量，從而也可以提高患者的依從性。所以這確實還有待確定，但如果你願意的話，這可能是一個潛在的輕微抵消，但我們覺得，在進入 2025 年時，我們處於非常有利的位置。

Okay. Thank you. Next question.

好的。謝謝。下一個問題。

Richard Vosser, JP Morgan.

摩根大通的理查沃瑟。

Hi, thanks for taking my questions. Two, please. One on amlitelimab Just as we think about the asthma data that's coming up and the 12-week dosing, could you just talk through your level of confidence that you'll see no detrimental reduction in efficacy there through the data?

你好，謝謝你回答我的問題。請給我兩份。一個是關於 amlitelimab 的，正如我們考慮即將出現的哮喘數據和 12 週的劑量一樣，您能否談談您對透過數據看到療效不會出現有害降低的信心程度？

And then secondly, question on itepekimab. Obviously, Dupixent in COPD has a broader label. The launch is going exceptionally well from the script trends. But what implications does that have for the residual opportunity for itepekimab in COPD? Thanks very much.

其次，關於 itepekimab 的問題。顯然，Dupixent 在 COPD 的應用範圍更加廣泛。從劇本趨勢來看，這次發表會進展異常順利。但這對於伊替尼在 COPD 治療中的剩餘機會有何影響？非常感謝。

Okay. Houman?

好的。霍曼？

Yeah. Thanks, Richard. Two quick answers and thank you for both questions. So just categorically, I obviously I haven't seen the data, just to be clear, but I don't expect based on the pharmacodynamics of amlitelimab in atopic dermatitis, a condition which is both clinically overlapping and pathophysiology overlapping, I don't expect any drop off at week 12.

是的。謝謝，理查。兩個簡短的回答，感謝您提出這兩個問題。因此，從類別上講，我顯然沒有看到數據，只是為了清楚起見，但基於 amlitelimab 在異位性皮膚炎中的藥效學，我不認為這種疾病在臨床上和病理生理學上都有重疊，我預計第 12 週不會出現任何下降。

In fact, what we saw with amlite is progressive increase throughout the duration of atopic dermatitis over 52 weeks, so I'm actually, comfortable that the pharmacodynamic half-life of amlite will continue to grow throughout the course of asthma. We remain studiously awaiting the outcome of the amlitelimab asthma result which should be this half of the year.

事實上，我們看到 amlite 的療效在 52 週的異位性皮膚炎病程中逐漸增加，因此我實際上確信，amlite 的藥效學半衰期將在整個氣喘病程中持續增長。我們仍在認真等待 amlitelimab 氣喘研究的結果，預計在今年半年公佈。

And then specifically talk about itepekimab. Just to challenge a little bit of the underlying premise of the question, while we were appropriately rewarded with a broad label for dupilumab with Type 2 inflammation in chronic bronchitis, I think that it's the population of former smokers is a very substantial one, and one that we led to science with both genetically and in terms of characterization of the patients while IL-33 secretion is substantially increased in bronchial alveolar lavage.

然後具體說一下itepekimab。只是想對這個問題的基本前提提出一點質疑，雖然我們適當地獲得了度普利尤單抗用於治療慢性支氣管炎 2 型炎症的廣泛標籤，但我認為，以前吸煙者的群體是一個非常龐大的群體，我們在基因和患者特徵方面都對其進行了科學研究，而 IL-33 的分泌在支氣管肺泡灌洗中顯著增加。

So actually, if anything, the opportunity is very substantial in the form of smokers that have significant morbidity and mortality, so you said, with COPD, and we remain steadfast in our view that in a success scenario, which we'll know fairly soon, the combination of products will reach a peak sales of more than $5 billion a year.

因此，實際上，如果有的話，那麼吸煙者的機會是非常巨大的，因為他們患有慢性阻塞性肺病，發病率和死亡率很高，我們仍然堅定地認為，在成功的情況下，我們很快就會知道，這些產品的組合將達到每年超過 50 億美元的峰值銷售額。

Brian, any further thoughts?

布萊恩，還有其他想法嗎？

Yeah, I'd like to compliment that with, again, like other therapeutic areas or disease states that we've gone in with our immunology portfolio, again, we are the first mover into the marketplace. So the biopenetration rate today is, again, just what we're doing with Dupixent and COPD, number one.

是的，我想再次稱讚一下，就像我們透過免疫學產品組合涉足的其他治療領域或疾病狀態一樣，我們是進入市場的先驅。因此，今天的生物滲透率再次成為我們對 Dupixent 和 COPD 所做的第一點。

And so as we go in there with both of these agents, we're going to be able to continue to grow patients, I think, on those therapies. But just nicely, as you said, this is going to open up the population and across the two. We've shown you that 2 by 2 before in the past, itepekimab plus Dupixent will open up the opportunity to reach more than 80% of the COPD population.

因此，當我們同時使用這兩種藥物時，我認為我們將能夠繼續增加使用這些療法的患者。但正如您所說，這將使兩國民眾之間的溝通更加順暢。我們之前已經向您展示過，itepekimab 加 Dupixent 將有機會覆蓋超過 80% 的 COPD 人群。

Again, around 2 million patients if you think about it across the G7, if you will. So they're both uniquely -- sit in unique places. They overlap ever so slightly, I think in the above 300 eos level in the Type 2 COPD patient population. But I think the complement of the two really shows that we're going after this disease state from all angles because there will be different patient populations that will benefit from both drugs.

再說一遍，如果你考慮整個 G7 國家，大約有 200 萬名患者。因此，它們都是獨一無二的——位於獨特的位置。我認為，它們略有重疊，在 2 型 COPD 患者群體中重疊程度在 300 eos 以上。但我認為兩者的互補確實表明我們正在從各個角度追蹤這種疾病狀態，因為不同的患者群體都會從這兩種藥物中受益。

Brian, just a quick addition before you go back to Paul, which is, I just want to remind everybody that itepekimab works in the high zenafil and the low zenafil population equally in terms of relative risk reduction and we do have a life cycle management strategy for itepekimab with CRS with MP. Our Dupixent story is now being rolled out in conjunction with our extremely valued partners, Regeneron.

布萊恩，在您回到保羅的話題之前，我只想快速補充一點，那就是，我只想提醒大家，就相對風險降低而言，伊替吉單抗對高西那非和低西那非人群的作用是相同的，並且我們確實有一個針對 CRS 和 MP 的伊替吉單抗的生命週期管理策略。我們的 Dupixent 故事現在正在與我們極其重要的合作夥伴 Regeneron 聯合推出。

Thank you, Richard, allowing Houman an opportunity to hijack the call. Next question.

謝謝你，理查德，給了霍曼一個劫持電話的機會。下一個問題。

Florent Cespedes, Bernstein.

弗洛朗·塞斯佩德斯、伯恩斯坦。

Good afternoon. Florent Cespedes from Bernstein. Two questions, please, on the pipeline. First on R&D budget. With a long list of Phase 2 products, so how will you manage the R&D budget going forwards? Good problem to have, but any color would be great.

午安.伯恩斯坦的 Florent Cespedes。請問關於管道有兩個問題。首先是研發預算。由於第二階段的產品清單很長，那麼您將如何管理未來的研發預算？這是一個好問題，但任何顏色都可以。

And my second question is for Thomas. We see more and more vaccines projects on the pipeline and on the new slot tables. I like the Phase 3 and the RSV for toddlers. Could you maybe elaborate a bit even though for 2026, but how you see these projects nicely, good addition to your existing RSV franchise? Thank you.

我的第二個問題是問湯瑪斯的。我們看到越來越多的疫苗項目正在籌備中，並出現在新的審批表中。我喜歡 Phase 3 和適合幼兒的 RSV。儘管對於 2026 年而言，您能否詳細說明一下，但您如何看待這些項目對您現有的 RSV 特許經營權的良好補充？謝謝。

Thank you, Florent. Managing the R&D budget, Francois?

謝謝你，弗洛朗。管理研發預算，弗朗索瓦？

Yes, Florent. Good afternoon. So for 2025, we expect a moderate increase in terms of R&D spend and investment. But don't forget that this comes over EUR900 million plus increase in 2024 over '23. And don't forget either that, obviously, as it is a case every year, we have projects being completed and new projects coming in -- new clinical trial coming in and out.

是的，弗洛朗。午安.因此，我們預計 2025 年研發支出和投資將適度增加。但不要忘記，到 2024 年，這一數字將比 2023 年增加 9 億歐元以上。而且也不要忘記，顯然，每年都是如此，我們有專案完成，也有新專案加入，有新的臨床試驗加入和退出。

So we are comfortable with the amount that we have for '25 with a slight increase over 2024. Once again, EUR900 million plus increase. For 2026, we have not provided any indication for the time being. We are working on it.

因此，我們對 2025 年的金額感到滿意，並且比 2024 年略有增加。再次增加9億歐元以上。對於2026年，我們暫時還沒有提供任何跡象。我們正在努力。

Thank you. All right, good. Thomas?

謝謝。好的，很好。托馬斯？

Thanks for the question, Florent. Indeed, I like the way you frame the question, Florent. We're really looking forward to beat an aggressive franchise. So the first proof was the Beyfortus that we just talked about at the beginning of the call. And as highlighted before, we want to make sure that we complement that with an RSV toddler approach for second season and thereafter as well as with an elderly approach moving forward with respiratory combinations.

謝謝你的提問，弗洛朗。確實，我喜歡你提出問題的方式，弗洛朗。我們非常期待擊敗一支咄咄逼人的球隊。因此第一個證明就是我們在通話開始時談到的 Beyfortus。正如之前所強調的那樣，我們希望確保在第二季及以後採用針對 RSV 幼兒的治療方法，並在老年人中採用呼吸道組合療法。

For the RSV toddler candidate you're talking about, indeed, when Phase 3, 2026 readout will be an important one. Why am I particularly excited about this one? Because it really complements very well what we're doing on Beyfortus. First season, you get your newborn protected with Beyfortus.

對於您談論的 RSV 幼兒候選人來說，確實，第 3 階段的 2026 年讀數將是一個重要訊息。我為什麼對這個特別興奮？因為它確實很好地補充了我們在 Beyfortus 上所做的事情。第一季，您可以使用 Beyfortus 保護您的新生兒。

Second season, you want to make sure that you're able to provide what we call complete protection, i.e., targeting by an intranasal product to go to the mucosal immunity and to prevent not only lower respiratory disease, but also upper respiratory disease, which is why we're going for the intranasal approach.

第二季，你要確保能夠提供我們所謂的全面保護，即透過鼻內產品達到黏膜免疫，不僅可以預防下呼吸道疾病，還可以預防上呼吸道疾病，這就是我們採用鼻內方法的原因。

We think it makes a lot of sense. There's a significant burden of disease still in kids one year, two years and three years of age. And we believe that we have a step forward that of any competitor in this area. That's why we're so excited about it.

我們認為這非常有意義。一歲、兩歲和三歲的兒童的疾病負擔仍然很重。我們相信，我們比該領域的任何競爭對手都領先一步。這就是我們對此感到如此興奮的原因。

Thank you, Thomas. Okay. Next question, please.

謝謝你，托馬斯。好的。請回答下一個問題。

David Risinger, Leerink.

David Risinger，Leerink。

Yes. Thanks very much, and congrats on all the strong business momentum. So my two questions are, first, what amount of nuvaxovid sales are factored into 2025 sales guidance? And second, should we expect top line press releases on Phase 2 trial results? Or will we need to wait for you to provide updates on them in conjunction with quarterly results calls? Thank you.

是的。非常感謝，並祝賀所有業務勢頭強勁。所以我有兩個問題：首先，nuvaxovid 的銷售額中有多少被計入了 2025 年的銷售指導中？其次，我們是否應該期待第二階段試驗結果的頂級新聞稿？或者我們需要等待您在季度業績電話會議中提供最新資訊嗎？謝謝。

Okay. Thank you. Nuvaxovid, Thomas.

好的。謝謝。努瓦克索維德，托馬斯。

So maybe thanks for the question, David. As you know very well, we've announced last year the collaboration with Novavax to make sure that we are really looking forward at building what we believe could be a competitive -- not only competitive, but a winning ticket for flu and COVID-19 combination. We always highlighted a couple of things that I like to stress again here today.

所以也許感謝你提出這個問題，大衛。眾所周知，我們去年宣布了與 Novavax 的合作，以確保我們真正期待建立一種我們認為不僅具有競爭力，而且是流感和 COVID-19 組合的致勝法寶。我們總是強調一些事情，今天我想在這裡再次強調。

First of all, the big objective of this alliance is really to get to the right commission vaccines, flu and COVID. And we believe this market to be well served needs to ensure that there is the right level of safety, efficacy and making sure that we have thermal stability.

首先，該聯盟的最大目標實際上是獲得正確的流感和新冠疫苗。我們相信，要好好服務這個市場，就需要確保適當的安全性和有效性，並確保具有熱穩定性。

And of course, when you have two winning leaders in Fluzone High-Dose and Flublok, that's why we're very happy that we have received the fast-track designation for both Phase 1/2 trials then with nuvaxovid. Of course, in 2025 and in 2026, months forward, we're going to start commercializing nuvaxovid first and foremost in the US. This in 2025, the first reason is to learn about the COVID-19 market. It will be our first time in the US.

當然，當 Fluzone High-Dose 和 Flublok 這兩個領先的藥物問世時，我們很高興獲得了 nuvaxovid 和 nuvaxovid 兩項 1/2 期試驗的快速通道資格。當然，幾個月後，在 2025 年和 2026 年，我們將首先在美國開始將 nuvaxovid 商業化。2025年，第一個原因是為了了解COVID-19市場。這是我們第一次去美國。

So we need to understand, first of all, how is the market behaving there on COVID-19. And if our hypothesis or the fact that there is room for actually a better tolerable COVID-19 vaccine is indeed confirmed into the marketplace. You know very well that there is a PDUFA date in the US for this product in April.

因此，我們首先需要了解市場在 COVID-19 疫情下的表現如何。如果我們的假設或事實確實存在一種耐受性更好的 COVID-19 疫苗，並且該假設確實在市場上得到證實。您很清楚，該產品在美國的 PDUFA 日期是四月。

So let's make sure that we first move forward to the PDUFA date with the level we have. And of course, we have not disclosed any sales targets specifically for COVID-19 in 2025 and 2026. But as you know very well, this has been already included with the guidance that has been shared with Francois. Again, it's going to be progressive learning, building on the market and then really launching, at scale our combination.

因此，讓我們確保首先按照我們現有的水平推進到 PDUFA 日期。當然，我們還沒有透露 2025 年和 2026 年專門針對 COVID-19 的銷售目標。但正如您所知，這已經包含在與 Francois 分享的指導中。再次強調，這將是漸進式的學習，在市場上建立，然後真正大規模地推出我們的組合。

Yeah. Thanks, Tom. And I think you said it about safety. I mean, it'd be interesting to have a non-mRNA COVID opportunity. And if that has a lower burden, we don't know. But from a safety perspective -- and that leads to being a stronger choice, we'll find out.

是的。謝謝，湯姆。我認為您說的是有關安全的問題。我的意思是，擁有非 mRNA COVID 機會將會很有趣。但這是否會降低負擔，我們不知道。但從安全角度來看——這是否是一個更強有力的選擇，我們將會發現。

It could be what changes the COVID-nineteen BCR rate, which has been collapsing recently.

這可能是改變 COVID-19 BCR 率的原因，該率最近一直在下降。

I think so. I think we all remember what it was like to get the safety challenges on route. But anyway, okay. Houman, over to you. Are you going to do press releases for Phase 2?

我認為是這樣。我想我們都記得在途中遇到的安全挑戰是什麼樣的。但無論如何，好吧。霍曼，交給你了。您會為第二階段發布新聞稿嗎？

Well, let me start with a very simple comment that we are very conscious of our materiality requirements. We will remain great stewards of that. That's the very first point beyond anything else. Now speaking specifically about clinical trials, we're also conscious of the embargo requirements of major meetings, and we need to be very thoughtful about that.

好吧，讓我先從一個非常簡單的評論開始，我們非常清楚我們的實質要求。我們將繼續做好這件事。這是最重要的一點。現在具體談到臨床試驗，我們也意識到重大會議的禁運要求，我們需要對此非常謹慎。

So we will absolutely not commit to publishing top line Phase 2 data as they come, except where their material or as part of a broader story. Please watch the broad story development around R&D and pipeline at Sanofi as we go. We are now becoming a science company.

因此，我們絕對不會承諾立即發布第二階段的頂線數據，除非它們是素材或作為更廣泛故事的一部分。請關注賽諾菲在研發和產品線方面的廣泛進展。我們現在正在成為一家科學公司。

Thank you. Well said. Okay, next question.

謝謝。說得好。好的，下一個問題。

Peter Verdult, BNP Exane.

法國巴黎銀行 Exane 的 Peter Verdult。

Hello, sir. How are you? Okay, it's Peter Verdult here from BNP Paribas Exane. Two questions. Houman, just on TL1A, really interesting asset in light of your data in UC and particularly at Crohn's and also given the market seems to describe all the value of this class to competing assets.

你好先生。你好嗎？好的，我是法國巴黎銀行 Exane 部門的 Peter Verdult。兩個問題。Houman，僅就 TL1A 而言，根據您在 UC 和特別是克羅恩病方面的數據，這確實是一項有趣的資產，而且市場似乎描述了此類資產對競爭資產的所有價值。

So recent KOL checks point to biomarker led strategies being keenly sought. So I'm just seeking confirmation from you and your partner, Teva, that a biomarker will be deployed in your Phase III program, timings on the Phase 3 start and whether you're considering going beyond IBD in your clinical development program?

因此，最近的 KOL 檢查表明，生物標記主導的策略受到熱切追捧。因此，我只是想向您和您的合作夥伴 Teva 尋求確認，在您的 III 期計劃中是否會部署生物標誌物、III 期開始的時間以及您是否考慮在臨床開發計劃中超越 IBD？

And then a very quick one for Francois on Dupixent, just simply on profitability dynamics in light of the COPD launch accelerating volumes and the manufacturing changes that you're putting through? The simple question, Francois, I'm not asking for numbers, but just will 2025 be a significant sort of gross margin driver as it relates to Dupixent? Or do we need to be a little bit more conservative and wait until 2026? Thank you.

然後請 Francois 快速回答一下 Dupixent 的問題，簡單談談在 COPD 上市加速以及你們正在進行的生產變革背景下的盈利動態？一個簡單的問題，弗朗索瓦，我不是在問數字，而是 2025 年是否會成為與 Dupixent 相關的重要的毛利率驅動因素？或者我們需要更保守一點，等到 2026 年？謝謝。

Thank you. The biomarkers question, Houman.

謝謝。關於生物標誌物的問題，Houman。

Hi, Peter and congratulations. I should start by saying. The TL1A story, yeah, we did a great deal around the TL1A, and we were quiet until the science began to speak for itself. Based on preliminary data, we're very excited about how competitive our molecule is. I don't share necessarily your KOL calls feedback that standard of care will require biomarker-based stratification as an obligatory option.

你好，彼得，恭喜你。我首先要說的是。是的，TL1A 的故事，我們圍繞 TL1A 做了很多工作，但我們一直保持沉默，直到科學開始為自己說話。根據初步數據，我們對我們的分子的競爭力感到非常興奮。我不一定同意您的 KOL 電話回饋，即標準護理將需要基於生物標誌物的分層作為強制性選擇。

But of course, we are active in thinking about how we design our Phase 3 trials to deliver the maximum value for patients. And in terms of life cycle management options, we are working diligently with our partner Teva to establish the best path forward with life cycle management options. More on this space in February, ECHO meeting.

但當然，我們正在積極思考如何設計我們的第三階段試驗，以便為患者帶來最大的價值。在生命週期管理選項方面，我們正在與合作夥伴 Teva 密切合作，以確定生命週期管理選項的最佳前進路徑。有關該領域的更多信息，請參閱二月份的 ECHO 會議。

And with that, I'll hand over to Francois and Brian for the next level of question.

接下來，我將把下一階段的問題交給 Francois 和 Brian。

Peter, on the question of gross margin, let me give you a little bit of insight. First of all, if you look at it four or five years ago, we were 4 to 5 percentage points lower than our peers in terms of gross margin. We have gone a long way because if you look at it in 2024, we were basically at par with our peers, which gives a good illustration of the way we manage our portfolio and we manage some efficiency program as well.

彼得，關於毛利率的問題，讓我給你一些見解。首先，如果回顧四、五年前，我們的毛利率比同業低4到5個百分點。我們已經走了很長一段路，因為如果你以 2024 年來看，我們基本上與同行持平，這很好地說明了我們管理投資組合的方式以及我們管理一些效率計劃的方式。

In 2025, we expect to see some further progress in our gross margin, which is partly coming from Dupixent, but not only. By the way, our growth even in 2024, and this is the case in 2025 and in the coming years, I would say we are not Dupixent dependent just to increase our gross margin. So it's a combination of factors, but there is a fair contribution from Dupixent, but it's not only Dupixent. And I must say, the other new product launches have a fair contribution to it as well.

到 2025 年，我們預計毛利率將進一步提高，這部分得益於 Dupixent，但不僅限於此。順便說一句，即使在 2024 年，我們的成長仍然會持續，2025 年及未來幾年也是如此，我想說，我們不會依賴 Dupixent 來提高毛利率。所以這是多種因素共同作用的結果，Dupixent 也做出了相當大的貢獻，但不僅僅是 Dupixent。而且我必須說，其他新產品的發布也對此做出了相當大的貢獻。

Thank you. Anything to add? No. Okay, good. And Peter will allow a little bit more time in the next call given the length of your new title.

謝謝。還有什麼要補充嗎？不。好的，很好。考慮到您新頭銜的長度，Peter 將在下次通話中給您多一點時間。

Steve Scala, TD Cowen.

TD Cowen 的 Steve Scala。

Thank you so much. Also on TL1A, has the best-in-class profile held up when the data is cut by biologic naive and biologic experienced patients? So that's the first question. And secondly, are you highly confident FDA will not ask for additional data such as the PPMS data for approval of tolebrutinib. And is the every week monitoring for three months likely to be what's in the label? Thank you.

太感謝了。同樣在 TL1A 上，當數據由生物學初治患者和生物學經驗豐富的患者剪切時，最佳同類概況是否能夠維持？這是第一個問題。其次，您是否非常有信心 FDA 不會要求提供諸如 PPMS 數據之類的額外數據來批准托布替尼？那麼，連續三個月每週進行監測是否與標籤上所寫的一致？謝謝。

Okay. I think we're straight to you, Houman.

好的。我想我們可以直接聯絡你，霍曼。

Yeah. Well, I don't want to undermine the discussion at ECHO later this month in terms of biologically naive and biological experience. Suffice it to say that we warmly invite you to the ECHO meeting to come and see the breadth of our data. I think you'll be pleasantly surprised. And then very specifically with PBMS and SBMS, as you know, we're working closely with the FDA who encouraged us to submit SBMS now. As you know, the results of the PPMS result comes out later in the year. You can infer exactly what the dataset requirement will be for SBMS in that regard.

是的。好吧，我不想破壞本月晚些時候在 ECHO 上關於生物學幼稚和生物學經驗的討論。我們熱烈邀請您參加 ECHO 會議，以了解我們數據的廣度。我想你會感到驚喜。然後非常具體地關於 PBMS 和 SBMS，如您所知，我們正在與 FDA 密切合作，他們鼓勵我們現在提交 SBMS。如您所知，PPMS 的結果將在今年稍後公佈。您可以準確推斷 SBMS 對資料集的要求是什麼。

Of course, any decision is subject to regulatory final active review. And then with respect to the label and monitoring, I think you'll see that the FDA will adhere pretty closely to the Phase 3 clinical trial protocol that's been the standard in this kind of space in terms of intensiveness and regularity of the monitoring, and we anticipate that that will play out in the label. We should be upfront and straightforward in saying that Sanofi will support any decision by the regulator to provide the most thoughtful and safe path for patients to take this disease modifying drug.

當然，任何決定都要接受監管部門的最終主動審查。然後關於標籤和監測，我認為你會看到 FDA 將非常嚴格地遵守第 3 階段臨床試驗方案，該方案在監測的強度和規律性方面一直是該領域的標準，我們預計這將在標籤中發揮作用。我們應該坦白說，賽諾菲將支持監管機構的任何決定，為患者提供最周到、最安全的途徑服用這種改善疾病的藥物。

Thank you, Houman. Next question, please.

謝謝你，Houman。請回答下一個問題。

Emmanuel Papadakis, Deutsche Bank.

德意志銀行的 Emmanuel Papadakis。

Thanks for taking the question. Yeah, Emmanuel Papadakis, Deutsche Bank. So maybe a question for Francois on the outlook for the operating margin. Just talk a little bit about potential for margin leverage. I know it's presumably we should see revenue growth beyond well beyond 2025.

感謝您回答這個問題。是的，德意志銀行的 Emmanuel Papadakis。所以也許我想問弗朗索瓦關於營業利益率前景的問題。稍微談論一下保證金槓桿的潛力。我知道我們大概應該可以看到 2025 年以後的營收成長。

We obviously have some financial considerations to take into account, the Regeneron co development lines, royalty lines perhaps. Just your thoughts on whether steady modest margin improvement in the midterm is a reasonable assumption?

顯然，我們需要考慮一些財務問題，例如再生元 (Regeneron) 的共同開發線和特許權使用費線。您認為中期利潤率穩定適度提高是否是合理的假設？

And then maybe a question for Herman on one of the handful of Phase 2 -- interesting Phase 2 data points are due this year. But balinatunfib, the oral TNF. The Phase 1 data last year showed moderate efficacy. You've emphasized the potential as a combination opportunity with biologics. In that setting, we do this right to say it relatively soon. What are you hoping to see in that? And is the plan to take it forward now as a biologics combination Phase 3? Thank you.

然後也許可以問赫爾曼一個關於第二階段的幾個有趣的數據點——第二階段的數據點將於今年公佈。但是 balinatunfib，口服 TNF。去年第一階段的數據顯示出中等療效。您強調了與生物製劑結合的潛力。在這種環境下，我們很快就說出了正確的說法。您希望看到什麼？現在是否計劃將其作為生物製劑組合的第三階段進行推進？謝謝。

Okay, Francois.

好的，弗朗索瓦。

Thanks, Emmanuel. For the medium term, I don't want to give a guidance, but directionally, I can help you a bit. Obviously, we expect a strong level of growth in the coming years, solid level of growth, let's say. Gross margin should continue to increase as well over the next coming years, as I said earlier. R&D, still early to say because, I mean, it depends on what the readout will be in the coming months.

謝謝，伊曼紐。就中期而言，我不想給予指導，但在方向上，我可以幫你一點忙。顯然，我們預計未來幾年將實現強勁成長，可以說是穩健的成長。正如我之前所說，未來幾年毛利率也應該會繼續增加。研發，現在說還為時過早，因為這取決於未來幾個月的讀數。

Directionally, G&A, you can expect that there will be flat to declining growth for the G&A part, but the sales and marketing part could increase a little bit because we have a fairly heavy program coming in. You were mentioning one important item, which is the profit sharing with Regeneron and the end of the reimbursement for R&D there, which is coming at the end of '26, beginning of '27. So this will put a little bit of pressure probably on in '27 on BOI. That being said, not in absolute value.

從方向上看，你可以預期，一般及行政管理部分的成長將持平或下降，但銷售和行銷部分可能會略有增加，因為我們有一個相當繁重的專案即將啟動。您提到了一項重要事項，即與 Regeneron 的利潤分享以及終止其研發報銷，這項事項將於 26 年底、27 年初完成。所以這可能會在 27 年對 BOI 造成一點壓力。話雖如此，但不是絕對值。

I can tell you anyway, our BOI will increase in absolute value each and every single year, but there is a possibility that it could be a little bit under pressure as a percentage of sales in '27 from what we can see today. It's still early. Let's not forget that we have other items that are coming in like the AMVUTTRA royalties, which is going to grow significantly in the future as well. So I think that's -- directionally that's what I can tell you without once again, I'm not providing a guidance for the medium term in terms of BOI.

無論如何，我可以告訴你，我們的 BOI 的絕對值每年都會增加，但從我們今天看到的情況來看，27 年其銷售額的百分比可能會有點壓力。現在還早。我們不要忘記，我們還有其他項目即將到來，例如 AMVUTTRA 特許權使用費，這在未來也將大幅成長。所以我認為—從方向上來說，這就是我可以告訴你的，但我不會再為 BOI 的中期發展提供指導。

Thank you. And I think you mentioned -- what you mentioned, the AMVUTTRA. I think that is an important point to consider. Houman, oral TNFR1?

謝謝。我覺得您有提到過——AMVUTTRA。我認為這是需要考慮的重要一點。Houman，口服 TNFR1？

Yeah. Thanks for the question. So firstly, we had pleasing results last year. The data are on track as we always committed to releasing that in the first half of this year and that's exciting. Just to dimensionalize that for you.

是的。謝謝你的提問。首先，我們去年取得了令人滿意的成績。數據一切順利，正如我們一直承諾在今年上半年發布的那樣，這令人興奮。只是為了讓您將其具體化。

Yes, of course, there's a logic for it to be used in combination treatment strategies, particularly in the modern era where we have seen the combination cytokine blockade can both increase the efficacy ceiling or surpass the efficacy ceiling and also provide durability, but I just want to be clear that as well as combination therapies, remember Sanofi is now becoming the premier immunology powerhouse, and we have network effects internally where we can combine our molecules to generate greater value for patients.

是的，當然，將其用於聯合治療策略是有邏輯的，特別是在現代，我們已經看到聯合細胞因子阻斷既可以提高療效上限，也可以超越療效上限，同時還能提供持久性，但我只想明確的是，除了聯合療法之外，請記住賽諾菲現在正在成為首屈一指的免疫學強國，我們內部具有網絡效應，我們可以結合我們的分子。

So just to be clear, in plaque psoriasis, not only is there optionality for combination therapy, but depending on the results, we'll certainly consider using it as monotherapy as a pre biologic small molecule TNFR1 signaling inhibitor. I should remind everybody however that rheumatoid arthritis will read out later in the year and that's an even more classically TNF mediated disorder. We're excited to see that in monotherapy and combination therapy and there are further indications supporting our broad lifecycle management strategy in immunology.

因此需要明確的是，在斑塊狀乾癬中，不僅可以選擇聯合治療，而且根據結果，我們肯定會考慮將其用作生物前小分子 TNFR1 訊號抑制劑的單一療法。然而我應該提醒大家，類風濕性關節炎將在今年稍後公佈，這是一種更典型的 TNF 介導的疾病。我們很高興地看到，在單一療法和聯合療法中，有進一步的跡象支持我們在免疫學領域的廣泛生命週期管理策略。

Yeah. I think, Houman let me just add on to the RA data will be important given the TNF driver. I think the question was also what are you hoping to see if safety is right, the combination opportunity is significant. And then we'll see on mono as well. But we look forward to that.

是的。我認為，Houman 讓我補充一點，RA 數據對於 TNF 驅動程式來說很重要。我認為問題還在於您希望看到什麼，如果安全性正確，那麼組合機會就很重要。然後我們還將看到單聲道。但我們對此充滿期待。

Okay, next question, please.

好的，請問下一個問題。

[Shirley Chen] Barclays. Okay, we'll come back to you --

[Shirley Chen] 巴克萊銀行。好的，我們會再聯絡你--

Can you hear me? Thank you. Hi, Shirley Chen here on behalf of Emily Field. Just moving back to Beyfortus, if I can. So when we're ordering and contracting for Beyfortus for the next RSV season happen, So just trying to understand a bit more about how much of first mover advantage we still have here for the next season? And how do you consider the pricing of Beyfortus year over year?

你聽得到我嗎？謝謝。大家好，我是 Emily Field 的 Shirley Chen。如果可以的話，我就回到 Beyfortus。因此，當我們為下一個 RSV 賽季訂購和簽約 Beyfortus 時，只是想更多地了解我們在下個賽季還有多少先發優勢？您如何看待 Beyfortus 逐年定價的變動？

So in 2024, we saw a slight price increase by 5% according to the American Academy of Pediatrics. So would you keep this trend or would you consider the price slightly differently for the next season due to the potential competition? Another question on broader vaccine business. So obviously, there's a lot of attention on nominee to adjustments. So are you concerned about like vaccine hesitancy as impacting your broader vaccine business, given how widely publicized this is, even this there are no changes in policy?

因此，根據美國兒科學會的數據，到 2024 年，我們看到價格小幅上漲了 5%。那麼，您會保持這種趨勢嗎？ 或者，由於潛在的競爭，您會對下一季的價格做出略微不同的考慮嗎？另一個問題是關於更廣泛的疫苗業務。顯然，提名人的調整受到了廣泛關注。那麼，考慮到疫苗猶豫不決問題已被廣泛宣傳，即使政策沒有變化，您是否擔心疫苗猶豫會影響您更廣泛的疫苗業務？

Great. Thomas?

偉大的。托馬斯？

Two great questions. Thank you very much, Shirley. First of all, on Beyfortus, maybe a couple of points on your questions on the ordering patterns and price. First of all, from an ordering pattern perspective, I think it's very important to be clear that RSV is not flu, so the product is not changing every year. It's not a seasonal product because of that.

兩個很好的問題。非常感謝，雪莉。首先，關於 Beyfortus，我想針對您的訂購模式和價格問題問幾點。首先，從訂購模式的角度來看，我認為非常有必要明確RSV不是流感，因此產品不會每年都會改變。因此，它不是季節性產品。

Even though immunization are much more focused on some part of the year, it's the same product all year long. So you don't have the same pre book effect that you have, for example, in Influenza. I think that's an important differentiator to have in mind. Having said that, more specifically for 2025, I think the zest in your question was about the fact that is there a first mover advantage? I would say yes, just because of the product profile.

儘管免疫接種主要集中在一年中的某個時間段，但全年使用的都是同一種產品。因此，您不會獲得與《流感》等書籍相同的預訂效果。我認為這是需要牢記的一個重要的區別因素。話雖如此，更具體地說對於 2025 年，我認為您問題中的重點在於是否存在先發優勢？我認為是的，只是因為產品簡介。

Again, if you look at our product profile, we have an unprecedented body of reward evidence showing massive reduction of hospitalization for newborns in countries that have used Beyfortus. And by the way, not the same drop in hospitalization in countries that have decided to go other ways than with Beyfortus. So I think that's an important factor to look at.

再一次，如果你看看我們的產品概況，我們有前所未有的大量獎勵證據，顯示在使用 Beyfortus 的國家，新生兒住院率大幅降低。順便說一句，在那些決定採用 Beyfortus 以外的其他方式的國家，住院率並沒有出現同樣的下降。所以我認為這是一個需要考慮的重要因素。

Now there will be maybe specifically for 2025 a little bit of a first mover advantage just because if you look at the US market, physicians, practitioners have used Beyfortus this year, are comfortable with it, have really appreciated not only the safety profile. And now that we have full supply, we are able to deliver whenever they want it in 2025. So we are really moving forward with this. On the price point of B42 in 2025, we are seeing the situation as no erosion of price point in 2025. We will hold there.

現在可能特別是針對 2025 年會有一點先發優勢，因為如果你看看美國市場，醫生、從業者今年已經使用了 Beyfortus，對它很滿意，不僅真正欣賞它的安全性。現在我們已經擁有充足的供應，能夠在 2025 年隨時交付。所以我們確實在推進這項進程。關於 2025 年 B42 的價格點，我們看到的情況是 2025 年價格點不會被侵蝕。我們將在那裡堅持下去。

On the second part second question, sorry, that you had on vaccine hesitancy, I don't think we are in the position to make a lot of conjecture about the future. But a couple of points I think that are important and valid to your questions. First of all, is vaccine hesitancy a concern? Yes, vaccine hesitancy is a concern for any vaccines head on this planet, but also on the fact that actually when there is vaccine hesitancy, there is less protection and there is more disease.

關於第二部分第二個問題，抱歉，您關於疫苗猶豫的問題，我認為我們沒有資格對未來做出太多的猜測。但我認為有幾點對於您的問題很重要且有效。首先，人們對疫苗猶豫不決是否令人擔憂？是的，疫苗猶豫是地球上任何疫苗負責人擔心的問題，但事實上，當人們對疫苗猶豫不決時，保護就會減少，疾病就會增加。

Interestingly, and that's what I want to close this point on, it's interesting to see that after three or four years of soft flu vaccination coverage rate, you see a comeback of influenza in the UK, in France, a little bit in Japan and many other markets, where actually there is an increase in the severity and the number of hospitalization due to influenza this winter. I think it's a good wake up call. And if vaccine goes too much the wrong way, we will see more and more disease. So we need more vaccines. We are welcoming two delegates about those; about the safety and the benefit they provide. And we feel confident about the future due to the quality of our products.

有趣的是，這也是我在結束本文時想說的，有趣的是，在軟流感疫苗接種覆蓋率下降三四年後，你會看到英國、法國、日本和許多其他市場的流感再次捲土重來，實際上今年冬天流感的嚴重程度和住院人數都有所增加。我認為這是一個很好的警鐘。如果疫苗接種過多而導致錯誤，我們將會看到越來越多的疾病。所以我們需要更多的疫苗。我們歡迎兩位代表討論這些問題；關於它們提供的安全性和好處。由於我們產品的品質，我們對未來充滿信心。

Thank you. Next question?

謝謝。下一個問題？

Eric Le Berrigaud, Stifel.

艾瑞克·勒貝里戈（Eric Le Berrigaud），Stifel。

Yes. Good afternoon. Thank you. Two questions. First on SARCLISA. Any chance to get a better understanding of what your ambition is with the drug? It's a two-player market where the other guy is having 95% market share. So if you are successful in closing the gap could be an exceptional opportunity for you. But it was first about data and now you have the data.

是的。午安.謝謝。兩個問題。首先是SARCLISA。有沒有機會更了解你對這種藥物的期望？這是一個雙頭市場，另一方佔有 95% 的市場份額。因此，如果您成功縮小差距，這對您來說可能是一個絕佳的機會。但這首先與數據有關，現在您有了數據。

It was then about formulation, you will soon have formulation. So probably the remaining question is the willingness to invest and support on the commercial side, a relaunch or a stronger launch based on those data. So where are you? What's the market intelligence is telling you? Is it too late?

然後就是配方，你很快就會有配方。因此，可能剩下的問題就是在商業方面進行投資和支持的意願、基於這些數據的重新啟動或更強勁的推出。那你在哪裡？市場情報告訴您什麼？是不是太晚了？

Is it becoming too much your market or you're not having too much time given patent Blackstone Royalties, anything to help us understand whether it can be a blockbuster for sure, but a multi-blockbuster, maybe. And the second question, a very short one, given the current dynamics with ALTUVIIIO, is that one your next blockbuster and no later than this year? Thank you.

它是否變得太過面向您的市場，或者您沒有太多時間考慮黑石專利使用費，任何可以幫助我們了解它是否能夠成為一部轟動性作品，但也許可以成為一部多重轟動性作品。第二個問題很短，考慮到 ALTUVIIIO 目前的動態，這是您的下一部重磅電影嗎？謝謝。

Well, I'll take the second part. It will be a blockbuster this year, ALTUVIIIO. Brian, SARCLISA ambition.

好吧，我選擇第二部分。ALTUVIIIO，今年會是一部轟動一時的電影。Brian，SARCLISA 的野心。

Yeah. And thank you so much for the question. I think you framed it really nicely. If you look at that CD38 marketplace, again, this is a marketplace where they've the physicians like the CD38 target for multiple myeloma, we estimate that that marketplace could be somewhere in the range of EUR16 billion by the 2030 timeframe.

是的。非常感謝您提出這個問題。我認為你把它構圖得非常好。如果你看 CD38 市場，你會發現在這個市場上，醫生喜歡用 CD38 治療多發性骨髓瘤，我們估計到 2030 年，這個市場的規模可能會達到 160 億歐元左右。

Well now, as Houman said, we've had a real strong drumbeat of new information coming out, of course, really favorable data, I think putting us in the first line therapy, but also the recent data that we've had for the on-body device. And I think that's not to be underestimated.

嗯，現在，正如霍曼所說的，我們收到了大量新資訊的報道，當然，這些是真正有利的數據，我認為這將使我們進入一線治療領域，而且最近我們還獲得了有關人體設備的數據。我認為這一點不容小覷。

The subcu formulation offers a significant advantage in terms of patient and nurse experience. Utilizing an on-body delivery device, we believe this could ease the use and reduce some of the treatment burden along with the strong efficacy and safety that we provided. So we absolutely do not think it's too late. We absolutely believe we have all of the elements we need now to compete in the marketplace. We are investing behind this asset as we've said before and we believe it's going to be a multi blockbuster.

皮下注射配方在病人和護理人員體驗方面具有顯著優勢。我們相信，利用一種體內輸送裝置，可以簡化使用，減少一些治療負擔，同時提供強大的功效和安全性。所以我們絕對不認為已經太晚了。我們絕對相信我們現在擁有在市場上競爭所需的所有要素。正如我們之前所說，我們正在投資這項資產，我們相信它將成為一部轟動一時的作品。

Yeah, maybe I'll just add to just ALTUVIIIO blockbuster this year. So pleased to have a potential blockbuster next year. I think Brian -- with the on-body device opportunity for nurse to manage multiple patients simultaneously is still from an oncology office perspective, still a major advantage because we do have great data. We do have an incredible medicine, and these things matter in a head-to-head race.

是的，也許今年我只會加入 ALTUVIIIO 大片。很高興明年能有一部賣座大片。我認為，布萊恩——從腫瘤科辦公室的角度來看，利用隨身設備讓護理師同時管理多名患者仍然是一個主要優勢，因為我們確實擁有大量數據。我們確實擁有令人難以置信的藥物，這些在正面競爭中至關重要。

Okay. Last question, I think.

好的。我想，這是最後一個問題。

Ricardo Benevides, Santander.

里卡多·貝內維德斯，桑坦德銀行。

Hello, everyone. Thank you for taking my question. Wanted to ask you regarding your outlook on tariffs. The Trump administration has openly stated that it has been considering placing tariffs on both APIs and pharmaceuticals. Right now, we know that the tariff outlook is still a bit uncertain.

大家好。感謝您回答我的問題。想問一下您對關稅的看法。川普政府已公開表示，一直在考慮對原料藥和藥品徵收關稅。目前，我們知道關稅前景仍然有點不確定。

But could you give us some light on how your top line or operating income could be affected if either 2.5% universal tariffs are implemented or more aggressive 25% tariffs to China are applied? And in more qualitative terms, how could you protect yourself against these measures? Post potentially increased production activity in the US? Try to ration for any potential medicine shortages? Thank you.

但是，您能否告訴我們，如果實施 2.5% 的普遍關稅或對中國徵收 25% 的更激進的關稅，您的營收或營業收入將受到何種影響？從更定性的角度來說，你如何保護自己免受這些措施的影響？美國的生產活動可能會增加嗎？嘗試定量供應以應對任何潛在的藥品短缺？謝謝。

Ricardo, Francois speaking. Just a couple of comments. First of all, it's difficult for us to comment on something that is not real today. So very, very difficult to comment. Just be aware of the fact that we have a significant industrial base in the US, which about 25% of what we market is coming from the US. So we are a little bit under indexed versus our commercial presence there. But once again, very difficult to comment on something that is still planned for discussion.

里卡多，我是法蘭索瓦。僅幾點評論。首先，我們很難對今天尚不存在的事情發表評論。因此很難發表評論。值得注意的是，我們在美國擁有重要的工業基礎，我們銷售的產品約 25% 來自美國。因此，與我們在那裡的商業存在相比，我們的指數有點低。但是再次，對於仍在計劃討論的事情發表評論非常困難。

That's it. Okay. Thank you very much, Francois. Thank you to everybody for the comments. We've got a busy year, I think, ahead of us. We made significant progress in 2024. We upgraded our EPS guidance twice and exceeded it. We continue to advance to becoming a focused science driven biopharma company. And as we entered 2025, we provided new guidance today, including mid- to high single digit sales growth expectation and a strong rebound in earnings as well as a solid outlook for our pipeline. So thank you for your interest in Sanofi.

就是這樣。好的。非常感謝，弗朗索瓦。感謝大家的評論。我想，我們將會迎來忙碌的一年。我們在 2024 年取得了重大進展。我們兩次上調了每股收益預期，並且超出了這一預期。我們將繼續努力成為一家專注於科學驅動的生物製藥公司。當我們進入 2025 年時，我們今天提供了新的指引，包括中高個位數的銷售成長預期、強勁的獲利反彈以及我們產品線的穩健前景。感謝您對賽諾菲的關注。

And with this, we'll now close the floor. Thank you.

現在，我們的討論就到此結束。謝謝。