Sanofi SA (SNY) 2025 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 2025 conference call for investors and analysts. As usual, you can find slides on sanofi.com.

大家好。這是來自賽諾菲IR團隊的Thomas Kudsk Larsen。歡迎參加2025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。

Please turn to slide number 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 risk 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 Universal Registration Document for a description of these risk factors.

請翻到第3張投影片。這裡包含一些常見的前瞻性陳述。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，這些陳述存在重大風險和不確定性，可能導致實際結果與預期結果有重大差異。我們建議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 表格和我們的法國通用註冊文件，以了解這些風險因素的描述。

As usual, we'll 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 or full year 2025 unless stated otherwise.

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進行評論。除非另有說明，所用數字均以百萬歐元為單位，且為 2025 年第四季或全年數據。

Please turn to slide number 4. First, we have a presentation which is a little longer due to full-year results. Then, we will take your questions. We aim at keeping it all to one hour, perhaps a little bit more, including questions. We appreciate other companies are also reporting today.

請翻到第4張投影片。首先，由於涉及全年業績，我們的報告會稍長。接下來，我們將回答您的問題。我們的目標是將整個過程控制在一個小時內，也許會稍微長一點，包括提問環節。我們知道今天也有其他公司發布財報。

For the Q&A, we have Olivier, Brian, and Thomas to cover our global businesses; as well as Roy, our General Counsel, and Brendan, Head of Manufacturing and Supply. For the Q&A, you can participate in two ways: either raise your hand in Zoom or submit your question using the Q&A feature.

在問答環節，我們邀請了 Olivier、Brian 和 Thomas 來介紹我們的全球業務；此外還有我們的總法律顧問 Roy 和製造與供應主管 Brendan。在問答環節，您可以透過兩種方式參與：在 Zoom 中舉手提問，或使用問答功能提交您的問題。

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

綜上所述，我現在將交接給保羅。

Well, thank you and hello, everyone.

謝謝大家，大家好。

In 2025, we continued to develop into an R&D-driven, AI-powered biopharma company. Our strategic progress was supported by the completion of the Opella transaction, allowing us to reinvest proceeds into business development and M&A opportunities while completing our EUR5 billion share buyback program. We've had a strong performance with 9.9% sales growth, and new launches reached EUR5.7 billion in sales. We're pleased to have achieved another blockbuster milestone last year with Altuviiio.

2025年，我們將持續發展成為一家研發驅動、人工智慧賦能的生物製藥公司。Opella 交易的完成為我們的策略發展提供了支持，使我們能夠將所得款項再投資於業務發展和併購機會，同時完成 50 億歐元的股票回購計畫。我們取得了強勁的業績，銷售額成長了 9.9%，新產品上市銷售額達到 57 億歐元。我們很高興去年憑藉 Altuviiio 取得了另一個里程碑式的成就。

We successfully launched two new medicines -- Qfitlia for haemophilia and Wayrilz for ITP -- and one vaccine, Nuvaxovid, to protect against COVID-19. We also achieved several positive Phase 3 results, including most of the amlitelimab program in AD and the Sarclisa subcutaneous formulation. Our innovation engine continues to make progress, replenishing Phase 1, including three promising gene therapies, our entry into ophthalmology.

我們成功推出了兩種新藥——用於治療血友病的 Qfitlia 和用於治療 ITP 的 Wayrilz——以及一種疫苗 Nuvaxovid，用於預防 COVID-19。我們也取得了一些正面的 3 期臨床試驗結果，包括大部分針對 AD 的 amlitelimab 計畫和 Sarclisa 皮下製劑。我們的創新引擎持續取得進展，補充了第一階段的研發投入，包括三種有前景的基因療法，以及我們進軍眼科領域的計畫。

Looking at Q4 performance on slide 6, we delivered very strong results with EUR11.3 billion in sales and 13.3% growth, supported, of course, by our key drivers.

從第 6 頁投影片中的第四季業績來看，我們取得了非常強勁的業績，銷售額達到 113 億歐元，成長 13.3%，當然，這得益於我們的關鍵驅動因素。

Turning to our launches on slide 7, I'm pleased to report that our newly launched medicines and vaccines grew 34% in 2025. Beyfortus continued to deliver with EUR1.8 billion in full-year sales, demonstrating the critical need for RSV protection. Altuviiio achieved blockbuster status, reaching EUR1.2 billion in full-year sales. Patient adoption continues to increase, with patients switching from both factor and non-factor medicines. Of note, Ayvakit reached $725 million in annual pro forma sales, slightly ahead of Blueprint's expectations from early 2025. Our newly launched medicines and vaccines demonstrate our commitment to innovation and the strength of our commercial organization.

翻到第 7 張投影片，看看我們的產品發布情況，我很高興地報告，2025 年我們新推出的藥品和疫苗數量增加了 34%。Beyfortus 全年銷售額達 18 億歐元，並持續保持強勁勢頭，證明了呼吸道合胞病毒 (RSV) 防護的迫切需求。Altuvivio 取得了巨大的成功，全年銷售額達到 12 億歐元。患者接受藥物治療的人數持續增加，患者既有從因子藥物治療的患者，也有從非因子藥物治療的患者。值得注意的是，Ayvakit 的年度預估銷售額達到了 7.25 億美元，略高於 Blueprint 對 2025 年初的預期。我們新推出的藥品和疫苗體現了我們對創新的承諾以及我們商業組織的實力。

Moving to slide 8, Dupixent reached EUR4.2 billion in the quarter and EUR15.7 billion in annual sales. Continued growth across anchor indications and expansion into COPD, CSU, and BP drove a more than 30% increase in patients over the past year. This underscores Dupixent's standing as the number-one prescribed biologic across dermatologists, pulmonologists, allergists, and ear, nose and throat specialists. The US regulatory acceptance for the allergic fungal rhinosinusitis indication in November brings us closer to a potential ninth indication, further expanding Dupixent's reach.

翻到第 8 張投影片，Dupixent 本季銷售額達到 42 億歐元，年銷售額達 157 億歐元。過去一年，主要適應症的持續增長以及向 COPD、CSU 和 BP 的擴展，推動了患者數量增長超過 30%。這凸顯了 Dupixent 作為皮膚科醫生、肺科醫生、過敏科醫生以及耳鼻喉科醫生處方量排名第一的生物製劑的地位。11 月，美國監管機構批准 Dupixent 用於治療過敏性真菌性鼻竇炎，這使我們距離潛在的第九個適應症更近了一步，進一步擴大了 Dupixent 的適用範圍。

Turning to vaccines, we maintain our leadership in influenza and RSV despite a challenging environment. Full-year sales reached EUR7.9 billion. In influenza, we gained US market share with the Fluzone High-Dose and Flublok, while Europe saw continued penetration. Beyfortus delivered a strong performance, growing 9.5% to EUR1.8 billion, ahead of our anticipated modest growth and driven by geographic expansion across Europe and the rest of the world. With real-world evidence confirming 87% to 98% effectiveness, Beyfortus has protected more than 11 million babies in more than 45 countries, thus preventing an estimated 200,000 hospitalizations to date.

在疫苗領域，儘管面臨挑戰，我們仍然在流感和呼吸道合胞病毒疫苗方面保持領先地位。全年銷售額達79億歐元。在流感領域，我們憑藉 Fluzone 高劑量疫苗和 Flublok 疫苗獲得了美國市場份額，而歐洲市場也持續滲透。Beyfortus 業績表現強勁，成長 9.5% 至 18 億歐元，高於我們預期的溫和成長，這主要得益於其在歐洲和世界其他地區的地域擴張。真實世界的證據證實，Beyfortus 的有效率達到 87% 至 98%，已在 45 多個國家保護了超過 1,100 萬名嬰兒，迄今估計已避免了 20 萬例住院。

We continue to strengthen our vaccines portfolio with strategic acquisitions that enhance our ability to protect older adults from serious diseases. In December, we completed the acquisition of Vicebio, adding a bivalent RSV-plus-human-metapneumovirus vaccine candidate to our pipeline. This program complements our existing RSV franchise and leverages the innovative Molecular Clamp technology for vaccine antigen design.

我們透過策略性收購不斷加強疫苗產品組合，從而增強我們保護老年人免受嚴重疾病侵害的能力。12 月，我們完成了對 Vicebio 的收購，將一種二價 RSV 加人偏肺病毒疫苗候選產品添加到我們的研發管線中。該計畫是我們現有 RSV 產品線的補充，並利用創新的分子鉗技術進行疫苗抗原設計。

We also announced our proposed acquisition of Dynavax Technologies Corporation, which we expect to close in the first quarter this year. This acquisition adds HEPLISAV-B to our portfolio, the leading adult hepatitis B vaccine in the US with a differentiated and convenient two-dose schedule. It also brings a shingles vaccine candidate currently in Phase 1/2 studies, further expanding our pipeline in vaccines for older adults. These strategic additions reinforce our commitment to innovation in vaccines.

我們也宣布了擬收購 Dynavax Technologies Corporation 的計劃，預計將於今年第一季完成。此次收購將 HEPLISAV-B 添加到我們的產品組合中，HEPLISAV-B 是美國領先的成人乙肝疫苗，採用差異化且方便的兩劑接種方案。它還帶來了一種目前處於 1/2 期研究階段的帶狀皰疹疫苗候選產品，進一步擴展了我們針對老年人的疫苗產品線。這些策略性措施強化了我們對疫苗創新的承諾。

Before moving to financials, I'm pleased to highlight Sanofi's key role in developing Publicly Available Specification 2090, or PAS 2090, the first industry-wide global standard for measuring and reducing environmental impact of medicines and vaccines across their life cycle, recently published, by the way, in the British Standards Institution. We co-developed this harmonized framework with industry to enable eco-design for footprint reduction, accurate environmental reporting, while addressing growing stakeholder demands for transparency. PAS 2090 marks an important moment for sustainable healthcare, showcasing how collaboration across the healthcare system can drive meaningful progress. True patient care means protecting not just individual health, but also planet health. This standard helps us to do both.

在談到財務狀況之前，我很高興地強調賽諾菲在製定公共可用規範 2090 (PAS 2090) 方面發揮的關鍵作用。 PAS 2090 是第一個用於衡量和減少藥物和疫苗在其整個生命週期內對環境影響的行業全球標準，順便一提，該標準最近已在英國標準協會發布。我們與業界共同製定了這個協調框架，以實現生態設計、減少碳足跡、準確的環境報告，同時滿足利害關係人日益增長的透明度要求。PAS 2090 標誌著永續醫療保健發展的一個重要時刻，它展示了醫療保健系統內部的協作如何推動有意義的進步。真正的病患關懷不僅意味著保護個人健康，也意味著保護地球健康。這項標準有助於我們做到這兩點。

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

謝謝。現在我將把發言權交給我們的財務長弗朗索瓦，讓他詳細介紹一下財務狀況。

Thank you, Paul, and hello to everyone.

謝謝你，保羅，大家好。

Next slide, please. I'm pleased to report that we achieved our strongest quarterly sales growth in Q4 2025. Net sales grew by 13.3% to EUR11.3 billion. Dupixent delivered double-digit growth with continued penetration across all indications. Dupixent also benefited from a favorable basis of comparison due to gross to net price adjustments in the previous year. Business EPS growth was strong at 26.7%, reflecting our disciplined execution on operational leverage.

請看下一張投影片。我很高興地報告，我們在 2025 年第四季實現了最強勁的季度銷售成長。淨銷售額成長13.3%，達到113億歐元。Dupixent實現了兩位數的成長，並在所有適應症領域持續滲透。由於上一年毛價與淨價進行了調整，Dupixent 也受益於有利的比較基礎。業務每股收益成長強勁，達到 26.7%，反映了我們在營運槓桿方面的嚴格執行。

Slide 14, please. Over the past three years, volume growth has accelerated and reached 34% on a compounded basis. Growth was driven by our successful launches and by Dupixent expansion across multiple indications, which continues to drive significant volume uptake eight years after the launch. Our ability to expand market reach while growing our margins demonstrate the strengths of our innovation and our strong commercial execution. To meet growing patient demand and deliver on our MFN commitment, we will continue investing in manufacturing capacity with a strategic focus on the US.

請看第14張投影片。過去三年，銷量成長加速，複合成長率達 34%。成長得益於我們成功的產品上市以及 Dupixent 在多種適應症中的擴展，而 Dupixent 在上市八年後仍持續推動著顯著的銷售成長。我們在擴大市場覆蓋範圍的同時提高利潤率的能力，體現了我們的創新實力和強大的商業執行力。為了滿足不斷增長的患者需求並履行我們對最不適合醫療用途的承諾，我們將繼續投資生產能力，並將策略重點放在美國。

Next slide, please. Our full-year 2025 results showcase the power of our business model, delivering strong growth with increased profitability. Sales reached EUR43.6 billion, representing 9.9% growth at constant exchange rates at the upper end of our guidance. This represents a higher underlying growth level than in 2024, given that we excluded hyperinflation impacts from our sales growth at the beginning of 2025. Business gross margin expanded by 1.8 percentage points to 77.5%, driven by favorable product mix and operational efficiencies.

請看下一張投影片。我們 2025 年全年業績展現了我們商業模式的強大實力，實現了強勁成長和獲利能力提升。銷售額達到 436 億歐元，以固定匯率計算成長 9.9%，處於我們預期的上限。鑑於我們在 2025 年初的銷售成長中排除了惡性通貨膨脹的影響，這意味著其潛在成長水準高於 2024 年。受有利的產品組合和營運效率的推動，業務毛利率成長了 1.8 個百分點，達到 77.5%。

Operating expenses increased by 7.9% as we increased R&D investments and supported our new product launches through sales and marketing investments. OpEx has decreased as a percentage of sales to 39.9%, thanks to our efficiency programs. Business operating income increased by 11.9%, with BOI margin reaching 27.8%. Business EPS excluding share buyback grew by 12.2%, in line with our guidance, and including share buyback, our business EPS grew by 15%. This demonstrates our ability to grow EPS faster than sales while investing in future growth.

由於我們增加了研發投入，並透過銷售和行銷投入支援新產品上市，營運費用成長了 7.9%。由於我們推行了提高效率的計劃，營運成本佔銷售額的比例已降至 39.9%。營業收入成長11.9%，營業利益率達27.8%。不計股票回購，公司每股收益成長 12.2%，符合我們的預期；計入股票回購，公司每股收益成長 15%。這證明了我們有能力在投資未來成長的同時，實現每股盈餘 (EPS) 增速超過銷售額增速。

Moving to slide 16, our free cash flow has returned to strong levels in 2025 at EUR8.1 billion, representing 18.5% of sales. We aim to sustainably reach free cash flow of at least 20% of net sales in the medium term. This strong cash flow generation illustrates the quality of our earnings and the effectiveness of our working capital management. A key contributor to this performance was our inventory optimization, as we reduced inventory by nearly 30 days. We are targeting a similar inventory reduction in 2026, which will help us to progress toward our 20% free cash flow targets. This disciplined approach provides us with significant financial flexibility to execute our capital allocation strategy.

翻到第 16 張投影片，我們的自由現金流在 2025 年已恢復到強勁水平，達到 81 億歐元，佔銷售額的 18.5%。我們的目標是在中期內可持續地實現自由現金流至少佔淨銷售額的 20%。強勁的現金流產生體現了我們獲利的品質和營運資本管理的有效性。實現這一業績的關鍵因素之一是我們的庫存優化，我們將庫存減少了近 30 天。我們計劃在 2026 年實現類似的庫存削減目標，這將有助於我們朝著 20% 的自由現金流目標邁進。這種嚴謹的方法為我們提供了極大的財務靈活性，以執行我們的資本配置策略。

Next slide, please. We ended 2025 with a strong capital structure, as highlighted by our low net debt, which increased slightly to EUR11 billion. We maintained a conservative 0.8 times net debt to EBITDA ratio. This conservative leverage provides flexibility for future external growth opportunities, even while maintaining our AA rating. We successfully deployed the EUR10.4 billion received from the Opella divestment into value-creating business development and many opportunities, such as Blueprint, Vicebio, Dren Bio DR-0201, Vigil, and some others as well. These divestments and acquisitions allowed us to accelerate our transformation as a biopharma company.

請看下一張投影片。截至 2025 年底，我們的資本結構穩健，淨負債較低，僅略微增加至 110 億歐元。我們維持了保守的淨債務與 EBITDA 比率，為 0.8 倍。這種保守的槓桿作用為未來的外部成長機會提供了靈活性，同時也能維持我們的AA評級。我們成功地將從 Opella 剝離中獲得的 104 億歐元投入到創造價值的業務發展和許多機會中，例如 Blueprint、Vicebio、Dren Bio DR-0201、Vigil 等。這些資產剝離和收購使我們能夠加速轉型為生物製藥公司。

Moving to the next slide, in 2025, we executed our capital allocation strategy across all four priorities. We significantly increased our organic growth investments in R&D, commercial capabilities, CapEx, and digital transformation. These investments fuel both current and future growth.

接下來是下一張投影片，2025 年，我們針對所有四個優先事項執行了資本配置策略。我們大幅增加了在研發、商業能力、資本支出和數位轉型方面的有機成長投資。這些投資將促進當前和未來的成長。

As I just mentioned, we deployed the Opella proceeds into strategic acquisitions. We proposed to increase our dividend for the 31st consecutive year to EUR4.12, up by 5% from the previous year. Finally, we completed our EUR5 billion share buyback program. We will pursue our capital allocation policy in 2026. Regarding share buybacks, we will execute a EUR1 billion share buyback program in 2026. The consistency of this approach demonstrates our commitment to sustainable value creation and shareholder returns while investing in long-term growth opportunities.

正如我剛才提到的，我們將 Opella 的收益用於策略性收購。我們提議連續第 31 年提高股息，每股股息為 4.12 歐元，比前一年增長 5%。最後，我們完成了50億歐元的股票回購計畫。我們將於2026年繼續執行我們的資本配置政策。關於股票回購，我們將在 2026 年執行一項 10 億歐元的股票回購計畫。這一做法的一致性表明，我們致力於在投資長期成長機會的同時，創造可持續的價值和股東回報。

Slide 19, please. Looking ahead to 2026, we expect to deliver a year of profitable growth close to what we achieved in 2025. For the full year 2026, we guide for high-single-digit growth in sales and for profitable growth, meaning business EPS growing slightly faster than sales. Be aware that this guidance is for the full year 2026 and does not necessarily apply individually to each and every single quarter in 2026.

請看第19張投影片。展望 2026 年，我們預期獲利成長將接近 2025 年的水準。對於 2026 年全年，我們預計銷售額將實現高個位數成長，並實現獲利成長，這意味著企業每股收益成長速度將略高於銷售額成長速度。請注意，此指導意見針對的是 2026 年全年，並不一定適用於 2026 年的每個季度。

Sales dynamics include further portfolio optimizations through divestments that will reduce sales by about EUR200 million in 2026. We expect vaccines sales to slightly decline in 2026. Our gross margin expansion is expected to continue with minimal tariff impact following the agreement reached with the US administration last December.

銷售動態包括透過剝離資產進一步優化投資組合，這將使 2026 年的銷售額減少約 2 億歐元。我們預計2026年疫苗銷售額將略有下降。繼去年12月與美國政府達成協議後，預計我們的毛利率將持續成長，關稅影響將降至最低。

Underlying R&D will increase moderately. In addition to this organic growth of R&D expenses, we have added a placeholder for potential future acquisitions, particularly for Phase 1 and Phase 2 assets. Sales and marketing expenses will increase to support growth and launches while we continue to target stable G&A expenses.

基礎研發投入將溫和成長。除了研發費用的自然成長外，我們還預留了未來潛在收購的資金，特別是針對第一階段和第二階段的資產。為支援成長和產品發布，銷售和行銷費用將會增加，同時我們將繼續努力保持一般及行政費用的穩定。

Our operating income is expected to include around EUR500 million of capital gains from disposal. As a reminder, the profit sharing line in our P&L is increasing faster than sales growth by more than 10 percentage points. We now expect a decrease of around EUR400 million in R&D reimbursement coming from Regeneron this year. This decrease will be more than offset by Amvuttra royalties, which are estimated at approximately EUR1 billion based on the latest consensus. This results in a positive impact of around EUR500 million to BY.

我們的營業收入預計將包括約 5 億歐元的處分資本利得。再次提醒大家，我們損益表中的利潤分成部分比銷售成長速度快 10 個百分點以上。我們現在預計今年來自 Regeneron 的研發報銷將減少約 4 億歐元。根據最新的共識估計，Amvuttra 的特許權使用費約為 10 億歐元，這將足以抵消這一減少。這將為 BY 帶來約 5 億歐元的正面影響。

Our financial outlook includes an increase of our financial expenses this year, driven by increased net debt from both 2025 and 2026 BD and M&A activities. Finally, we expect a stable effective tax rate.

我們的財務展望包括今年財務支出的增加，這是由於 2025 年和 2026 年的業務拓展和併購活動導致淨債務增加。最後，我們預期有效稅率將維持穩定。

I now hand over to Houman to provide an update on the progress of our innovative pipeline.

現在我將把發言權交給侯曼，讓他介紹我們創新產品線的進展。

Thank you, François.

謝謝你，弗朗索瓦。

2025 has been a year of significant delivery across our pipeline. I'll walk you through the highlights. On pipeline delivery, we achieved 12 Phase 3 readouts and 15 Phase 2 readouts and then added 10 new molecules to Phase 1, including three gene therapies, emphasizing our greater focus on research, supported by business development, to replenish our early stage pipeline.

2025年是我們產品線交付量顯著成長的一年。我將帶你了解重點內容。在產品線交付方面，我們實現了 12 個 3 期臨床試驗結果和 15 個 2 期臨床試驗結果，然後又將 10 個新分子加入 1 期臨床試驗，其中包括 3 個基因療法，這凸顯了我們更加註重研發，並以業務發展為支撐，以補充我們早期產品線的決心。

On the regulatory front, we obtained 20 regulatory approvals and 22 acceptances, including nine priority reviews in addition to other designations, underscoring the progress we've made. Most importantly, we provided patients with three new medicines and vaccines: Qfitlia, the first RNAi antithrombin medicine in hemophilia, approved in the US and China; Wayrilz, the first BTK inhibitor in ITP, approved in the US and the EU; and our recombinant COVID-19 vaccine with full approval in the US and the EU. All these highlights represent meaningful progress in delivering transformative medicines and vaccines to patients worldwide.

在監管方面，我們獲得了 20 項監管批准和 22 項接受，其中包括 9 項優先審查以及其他指定，這凸顯了我們所取得的進展。最重要的是，我們為患者提供了三種新藥和疫苗：Qfitlia，首個用於治療血友病的 RNAi 抗凝血酶藥物，已在美國和中國獲批；Wayrilz，首個用於治療 ITP 的 BTK 抑製劑，已在美國和歐盟獲批；以及我們在美國和歐盟獲得全面批准的重組 COVID-19 疫苗。所有這些亮點都代表著在向全球患者提供變革性藥物和疫苗方面取得了實質進展。

Please turn to the next slide. Turning to the Q4 highlights, where we received approvals including Dupixent for CSU in the EU, Teizeild for stage 2 T1D in the EU, Wayrilz for ITP in the EU, Cerezyme for Gaucher Disease type 3 in the US. We strengthened our position in China with four approvals, something that I will return to again today. We received regulatory submission acceptance for Dupixent in AFRS in the US, Teizeild stage 2 T1D for children in the US, and SP0087, a rabies vaccine, in the EU.

請翻到下一張投影片。接下來是第四季度的亮點，我們獲得了多項批准，包括用於治療慢性自發性蕁麻疹的 Dupixent 在歐盟的批准、用於治療 2 期 1 型糖尿病的 Teizeild 在歐盟的批准、用於治療特發性血小板減少性紫癜的 Wayrilz 在歐盟的批准以及用於治療 3 型戈謝病的 Cerezyme 在美國的批准。我們獲得了四項批准，鞏固了我們在中國的地位，今天我將再次談到這一點。我們在美國獲得了治療 AFRS 的 Dupixent 的監管申請受理，在美國獲得了治療兒童 2 期 T1D 的 Teizeild 的監管申請受理，並在歐盟獲得了狂犬病疫苗 SP0087 的監管申請受理。

On Phase 3 readouts, amlitelimab delivered more positive results in atopic dermatitis and Dupixent met its primary endpoint in AFRS. Tolebrutinib did not meet its primary endpoint in the PERSIS study for PPMS. As a result, we will not pursue its regulatory submission. Ending with pivotal Phase 3 starts, we initiated the second major study for COPD, two duvakitug studies, each in Crohn's disease and ulcerative colitis, and one Wayrilz in IgG4-related disease.

在第 3 期臨床試驗結果中，amlitelimab 在異位性皮膚炎方面取得了更積極的結果，而 Dupixent 在 AFRS 中達到了主要終點。在 PERSIS 研究中，托布替尼未能達到其治療 PPMS 的主要終點。因此，我們將不再繼續推進其監管申報。在關鍵的 3 期臨床試驗啟動後，我們啟動了針對 COPD 的第二項主要研究、針對克羅恩病和潰瘍性結腸炎的兩項 duvakitug 研究，以及針對 IgG4 相關疾病的一項 Wayrilz 研究。

Next slide, please. I'll start with amlitelimab, whose recent data provides increasing confidence in progressive, long-term sustained benefit and patient convenience. Data across COAST 1, COAST 2, and SHORE Phase 3 studies and the ATLANTIS open-label Phase 2 study demonstrated progressively increasing efficacy over time, with no evidence of plateau for week 24 to 52. This validates the potential for both monthly and quarterly dosing from the start, offering significant patient convenience as either monotherapy or combined with topical corticosteroids, an important background therapy used in the real world. Amlitelimab was well tolerated with an acceptable safety profile.

請看下一張投影片。我先來談談 amlitelimab，它最近的數據越來越讓人相信它能帶來持續的長期療效和病人便利。COAST 1、COAST 2 和 SHORE 3 期研究以及 ATLANTIS 開放標籤 2 期研究的數據表明，隨著時間的推移，療效逐漸增強，在第 24 週至第 52 週期間沒有出現平台期。這證實了從一開始就可以按月或按季度給藥的潛力，無論是作為單一療法還是與局部皮質類固醇聯合使用，都能為患者帶來極大的便利，而局部皮質類固醇是現實世界中常用的重要背景療法。Amlitelimab耐受性良好，安全性可接受。

Much of our amlitelimab OCEANA global atopic dermatitis program has now been delivered, including Phase 2 and Phase 3 studies evaluating its efficacy and safety when administered in monotherapy and in combination. Remaining studies -- AQUA, in patients with background TCS and TCI with inadequate response to biologics or JAK inhibitors; and ESTUARY, the randomized maintenance study -- we expect both readouts in the second half of 2026, completing our comprehensive package for regulatory submission.

我們針對異位性皮膚炎的 amlitelimab OCEANA 全球計畫的大部分工作已經完成，包括評估其作為單藥療法和聯合療法時的療效和安全性的 2 期和 3 期研究。剩餘的研究——AQUA（針對背景 TCS 和 TCI 對生物製劑或 JAK 抑制劑反應不足的患者）和 ESTUARY（隨機維持治療研究）——我們預計這兩項研究的結果都將在 2026 年下半年公佈，從而完成我們提交監管部門的綜合資料包。

Next slide, please. China remains a strategic priority with significant progress made by our regional team. We obtained approvals for global medicines: Cablivi, our anti- von Willebrand factor antibody for acquired TTP; and Qfitlia. For China-only medicines, we received approvals for Myqorzo for obstructive hypertrophic cardiomyopathy and for Redemplo in patients with familial chylomicronaemia syndrome. These approvals demonstrate our commitment to bringing innovative medicines and treatments to Chinese patients and to leverage Chinese innovation in doing so.

請看下一張投影片。中國仍然是我們的戰略重點，我們的區域團隊已取得了顯著進展。我們獲得了全球藥物的批准：Cablivi，一種用於治療獲得性 TTP 的抗血管性血友病因子抗體；以及 Qfitlia。對於僅在中國銷售的藥物，我們獲得了用於治療梗阻性肥厚型心肌病變的 Myqorzo 和用於治療家族性乳糜微粒血症的 Redemplo 的批准。這些批准表明我們致力於為中國患者帶來創新藥物和療法，並在此過程中充分利用中國的創新能力。

Next slide, please. Now, let me share an update on our key mid- and late-stage pipeline projects. Our immunology pipeline has been strengthened by having delivered most of amlitelimab's Phase 3 programs in AD and duvakitug having advanced to Phase 3 for CD and UC. Lunsekimig will provide data on asthma this half and has potential for life cycle opportunities. Brivekimig is now moving to Phase 2b.

請看下一張投影片。現在，讓我來分享一下我們重點的中後期研發專案的最新進展。我們的免疫學研發管線得到了加強，amlitelimab 在 AD 領域的大部分 3 期項目已經完成，而 duvakitug 在 CD 和 UC 領域也已進入 3 期。Lunsekimig 將在本半年提供氣喘數據，並具有生命週期機會的潛力。Brivekimig 現在進入 2b 階段。

In neurology, tolebrutinib is still under review for the EU for SPMS, frexalimab in Phase 3 for RMS and SPMS, and riliprubart for Phase 3 for CIDP. In rare disease and oncology, Wayrilz is making progress, with its life cycle plans beyond ITP; venglustat in Phase 3 for GD3 data coming very soon; and Sarclisa expanding with a subcutaneous formulation. Our vaccines portfolio includes multiple programs across pneumococcal disease, yellow fever, meningitis, RSV, and pandemic preparedness.

在神經病學領域，托布替尼（tolebrutinib）仍在歐盟接受審查，用於治療繼發性多發性硬化症（SPMS）；弗雷沙利單抗（frexalimab）處於治療復發緩解型多發性硬化症（RMS）和繼發性多發性硬化症（SPMS）的 3 期臨床試驗階段；利髓性神經炎（rilipcx）在罕見疾病和腫瘤領域，Wayrilz 正在取得進展，其生命週期計劃已超越 ITP；venglustat 已進入 GD3 的 3 期臨床試驗，數據即將公佈；Sarclisa 也正在拓展皮下製劑。我們的疫苗組合涵蓋肺炎鏈球菌疾病、黃熱病、腦膜炎、呼吸道合胞病毒和疫情防範等多個項目。

Next slide, please. On my last slide, I'll cover the '26 and '27 news flow updates since December's year-end late-stage pipeline review. This year, we expect the remaining Phase 3 data for amlitelimab in AD and Phase 2 for lunsekimig in asthma, rare disease, the venglustat Phase 3 readouts, if positive regulatory submissions will follow. We anticipate multiple regulatory submissions based on data we already received last and this year, as well as regulatory decisions for medicines and vaccines under review. Next year, we will get the Phase 2b data for brivekimig in HS, followed by Phase 3 studies of frexalimab in RMS and riliprubart in CIDP.

請看下一張投影片。在最後一張投影片中，我將介紹自 12 月底後期管道審查以來 2026 年和 2027 年的新聞動態更新。今年，我們預計，如果監管部門提交積極申請，將會有amlitelimab治療AD的剩餘3期數據、lunsekimig治療氣喘和罕見疾病的2期數據以及venglustat 3期結果公佈。我們預計會根據去年和今年已經收到的數據提交多份監管申請，以及正在審查中的藥品和疫苗的監管決定。明年，我們將獲得 brivekimig 治療 HS 的 2b 期數據，隨後是 frexalimab 治療 RMS 和 riliprubart 治療 CIDP 的 3 期研究。

My sincere thanks to all Sanofi R&D colleagues who share my commitment to advancing our pipeline from research to regulatory approval. This represents a rich, diversified news flow that we believe will continue to drive value creations for patients, society, and of course, for Sanofi.

我衷心感謝所有賽諾菲研發部門的同事，他們和我一樣致力於推動我們的產品線從研發到監管審批的進程。這代表著豐富多元的新聞流，我們相信這將繼續為病人、社會以及賽諾菲創造價值。

So we'll now open the call to questions. (Event Instructions) Now, we'll take the first question. Please go ahead.

現在我們開始接受提問。（活動說明）現在，我們來回答第一個問題。請繼續。

Zain Ebrahim, JPMorgan.

Zain Ebrahim，摩根大通。

Hi there. Zain Ebrahim, JPMorgan. Thanks for taking my questions. My first question is on Dupixent rollouts in CSU and COPD, which sound like they've been particularly strong. But can you elaborate on how those rollouts are progressing and remind us of the biologic penetration in each of these indications and how Dupixent is faring against competition from Rhapsido in CSU and Nucala in COPD? That's my first question.

你好呀。Zain Ebrahim，摩根大通。謝謝您回答我的問題。我的第一個問題是關於 Dupixent 在 CSU 和 COPD 領域的推廣情況，聽起來這兩個領域的推廣情況特別好。您能否詳細說明這些推廣進展情況，並提醒我們每種適應症的生物滲透率，以及 Dupixent 在 CSU 領域與 Rhapsido 的競爭以及在 COPD 領域與 Nucala 的競爭情況如何？這是我的第一個問題。

And my second question is a vaccines question. Just in terms of within your overall vaccines guidance, what you're assuming for Beyfortus in '26 in terms of growth and how that looks for the US versus ex-US. Thank you.

我的第二個問題是關於疫苗的。就您整體疫苗指導而言，您對 Beyfortus 在 2026 年的成長有何假設？以及美國市場與美國以外市場的情況如何？謝謝。

Okay. Thanks, Zain. Brian, Dupixent?

好的。謝謝你，Zain。Brian，Dupixent？

Thank you, Zain, so much for the question. So I'll go a bit broader and then I'll focus in on a couple of those indications. So as you look at our performance in 2025, really strong performance, 25% growth year over year, and we culminated that with a really strong Q4, and I'll talk about that here in a minute, 32%. Now, this was driven not just based on those two indications that you highlighted, but the foundation of our indications grew as well because it's a volume-driven growth story that we saw in 2025.

Zain，非常感謝你的提問。所以我先從更廣的角度來談，然後再專注在其中幾個指標上。所以，展望我們 2025 年的業績，表現非常強勁，同比增長 25%，而第四季度更是取得了非常強勁的成績，我稍後會詳細談談，增長了 32%。現在，這不僅僅是基於你強調的那兩個跡象，而且我們的跡象基礎也在不斷擴大，因為我們在 2025 年看到了一個由銷售驅動的成長故事。

Now, of course, those were on our base indications, but at the launch of COPD, the launch of CSU, and the launch of BP were new sources of growth that were not in our base in 2024, which allowed us to accelerate growth, culminating actually in that Q4 that I talked about there just a bit. And I'll highlight COPD and CSU in just a minute, but that 32% growth that we saw at the end of the year is really a reflection of those not being in our base, but being strongly in Q4 performance that we saw. Now, as we go forward into 2026, we expect that growth to normalize, as we talked about, as we've seen before, and we're well on track to deliver our longer-term guidance by 2030 of greater than 22 -- around EUR22 billion sales.

當然，這些都是我們的基本適應症，但 COPD、CSU 和 BP 的推出是新的增長來源，這些增長來源在我們 2024 年的基本適應症中並不存在，這使我們能夠加速增長，最終在第四季度達到了頂峰，我剛才稍微提到了一下。我稍後會重點介紹 COPD 和 CSU，但我們在年底看到的 32% 的增長實際上反映出這些疾病不在我們的基數範圍內，而是在我們看到的第四季度業績中表現強勁。現在，展望 2026 年，我們預計成長將如我們之前所討論和看到的那樣趨於正常化，並且我們預計在 2030 年實現超過 220 億歐元的長期銷售目標。

Now, specifically on COPD and CSU, I've spoken about COPD quite a lot. It was an inflection point for this year, as you can see from the performance, which was, again, being the first biologic, really the first innovative therapy in more than 10 years in the COPD space. And we've seen a really good response from the physicians. Now, remember, we were already in the pulmonologist offices with asthma and having the leading asthma therapy beforehand. So it was really nice compliment.

現在，具體來說，關於慢性阻塞性肺病 (COPD) 和慢性蕁麻疹 (CSU)，我已經談了很多關於 COPD 的內容。從業績可以看出，這是今年的一個轉捩點，因為這是 COPD 領域 10 多年來第一個真正的創新療法，也是第一個生物製劑。我們看到了醫生們非常好的回饋。請記住，我們之前已經因為氣喘去肺科醫生那裡就診，並且接受了最先進的氣喘治療。所以這真是個很棒的讚美。

CSU is a very similar story. We've seen a really rapid uptake in the CSU launch. But again, remember, we were also already the leader in the dermatologist offices and the allergist offices with multiple indications, now eight indications in the US. So we've seen that those have contributed really nicely to our growth.

科羅拉多州立大學的情況也非常相似。我們看到 CSU 的推出獲得了非常迅速的認可。但請記住，我們之前在皮膚科診所和過敏科診所也已經是領先者，擁有多種適應症，現在在美國有八種適應症。所以我們看到，這些都對我們的成長做出了非常好的貢獻。

Final point I'll make on CSU, because you asked a question about the competitors, Rhapsido. We don't really zoom in on one. We think competitors across all the immunology indications are really good because the biopenetration rates are extremely low. AD is only 18% still to date, and it's more than eight years into our launch. CSU, we believe, is in the low-teens. So again, this is a place where you're going to continue to see the market growth as well, which is great when we have new competitors coming.

關於 CSU，我最後要說一點，因為你問了關於競爭對手的問題，Rhapsido。我們並沒有真正放大觀察其中一個。我們認為，所有免疫學適應症領域的競爭對手都非常優秀，因為它們的生物滲透率極低。截至目前，廣告支出僅佔 18%，而我們的產品發布已經超過八年了。我們認為，CSU 的排名在十幾名左右。所以，這裡也將繼續保持市場成長，這在有新競爭對手加入的情況下是件好事。

Okay. Thomas?

好的。托馬斯？

Thank you, Zain, for the question. So as it comes to Beyfortus specifically, first of all, let me say that we are happy about the 2025 performance, with an increase of a bit more than 9% year on year. When you recall very well, but on the Q2 earnings call, we had mentioned modest growth expectation for 2025. So happy about the performance. As you've noticed, it's a performance that's coming from broadening the reach to more and more countries, and Beyfortus is now available in more than 45 countries.

謝謝你的提問，Zain。就 Beyfortus 而言，首先，我想說我們對 2025 年的業績感到滿意，年成長略高於 9%。如果你記憶猶新的話，我們在第二季財報電話會議上曾提到，我們對 2025 年的成長預期較為溫和。對演出非常滿意。正如你所看到的，這種表現源於其覆蓋範圍不斷擴大到越來越多的國家，Beyfortus 目前已在超過 45 個國家/地區提供服務。

So as it comes to 2026 outlook, it's a bit early to be very specific on the performance of the product. However, I can say a few words about the dynamics. I think what's very important to have in mind is that there is a little bit of a different dynamic between US and non-US, I think that's included in your questions.

因此，展望 2026 年，現在就具體說明產品的性能還為時過早。不過，我可以簡單談談其中的動態。我認為非常重要的一點是，美國和非美國之間存在著一些不同的動態，我認為你的問題中已經包含了這一點。

On the US front, you have seen the recent changes on the pediatric immunization schedule, still very recent. As you have seen from a recommendation perspective, nothing has changed for Beyfortus in terms of recommendation or coverage. Now, will it create and to what extent confusion for parents and HCPs? Too early to say. We'll need to see that in the coming years -- in the coming months, and we'll be able to tell you a bit more at Q2 earnings call more about Beyfortus in the US.

在美國方面，你們已經看到了兒童免疫接種計劃的最新變化，這些變化仍然很新。從建議的角度來看，Beyfortus 在推薦或覆蓋範圍方面沒有任何變化。那麼，這會為家長和醫護人員帶來多大的困惑呢？現在下結論還為時過早。我們需要在未來幾年——未來幾個月——觀察情況，我們將在第二季財報電話會議上告訴大家更多關於Beyfortus在美國的情況。

As of outside of the US, we will expand the geographic coverage as we've done over the past two years. And the last point I will refer to on Beyfortus, for those that have not seen, there has been a very nice (inaudible) publication at the end of December 2025. This is the first real-world evidence, head-to-head comparison between the use of either maternal immunization or passive immunization with Beyfortus. And you've seen that on every single endpoint, Beyfortus is doing better than the competitor.

在美國以外，我們將像過去兩年一樣擴大地理覆蓋範圍。關於 Beyfortus，我最後要提一點，對於那些還沒看過的人來說，2025 年 12 月底有一份非常好的（聽不清楚的）出版品。這是第一個真實世界的證據，直接比較了使用母體免疫或被動免疫（使用 Beyfortus）的效果。你已經看到，在每個終端機上，Beyfortus 的表現都優於競爭對手。

Thank you very much.

非常感謝。

Thank you for that, Thomas. Next question, please.

謝謝你，托馬斯。下一個問題。

Ben Jackson, Jefferies.

本·傑克遜，傑富瑞集團。

Brilliant. Thank you for the question. Just two for me, please. I guess previously, you've spoken about a range or numbers of peak sales estimates around amlitelimab. And perhaps now that we've had some additional data, has your view in any of this changed at all?

傑出的。謝謝你的提問。請給我兩個。我猜您之前曾談到過關於 amlitelimab 的銷售高峰預測範圍或數量。現在我們有了更多數據，你對此事的看法是否有改變？

And Houman, perhaps if you could flesh that out, and you've had a little bit of time to talk to KOLs now and figure out how they're feeling, what is the feedback that you're getting on the additional results? Not just kind of the positive parts on it too, but if I can push you, what are the pinch points? What are the bits that they've still got a little bit of uncertainty or questions over as well, and how can you address those? So just rounding that up would be brilliant. Thank you.

侯曼，或許你可以詳細說明一下，你現在已經有一些時間與 KOL 交流，了解他們的感受，你從其他結果中得到了哪些回饋？不只是它的優點，如果可以的話，我想問它的缺點是什麼？他們還有哪些方面存在一些不確定或疑問？你如何解決這些問題？所以，把數字四捨五入一下就太好了。謝謝。

Thanks, Ben. Brian, do you want to give a sort of broad view?

謝謝你，本。布萊恩，你想從宏觀角度談談你的看法嗎？

Yeah, and thank you so much for the question, Ben.

是的，非常感謝你的提問，本。

I think if you think about the broad view of this -- and again, remember that we were always bullish on this from an AD perspective, and I think Houman will probably talk about that -- as you think about this marketplace, it's still really developing. We talked about the biopenetration; I mentioned, 18%. It'll more than double. I'm confident that it'll more than double.

我認為，如果你從更廣闊的角度來看待這個問題——再次強調，從廣告投放的角度來看，我們一直看好這一點，而且我認為侯曼可能會談到這一點——當你思考這個市場時，你會發現它仍在不斷發展。我們討論了生物滲透性；我提到，18%。將會翻一番以上。我相信它會翻倍以上。

If you look at what psoriasis has done, this is a marketplace that's going to continue to grow. And if you look at it today, as new mechanisms come into the marketplace, like we've seen, it actually accelerates the growth of the marketplace, much like psoriasis, so on and so forth. So having a new mechanism like this with a variety of areas in which to differentiate it, I believe, I mean, we remain extremely confident about the opportunity in that big marketplace.

從銀屑病的發展來看，這是一個將會持續成長的市場。如果你看看今天的情況，隨著新的機制進入市場，就像我們所看到的，它實際上加速了市場的成長，就像銀屑病等等一樣。因此，有了這樣一種可以在多個方面進行差異化的新機制，我相信，我的意思是，我們對在這個巨大的市場中的機會仍然充滿信心。

Houman, do you want to --

侯曼，你想…--

Yeah. Just to top and tell what Brian has said, I couldn't support more the importance of a novel mechanism in this space, which goes beyond straightforward anti-cytokine blockade. Of course, that's an excellent mechanism in disease. But the addition of a T cell modulator with -- the promise, and I underline the word, of long-term immune normalization is obviously very attractive in the conversation.

是的。我完全同意布萊恩所說的，我非常支持在這個領域引入一種新的機制的重要性，這種機制超越了簡單的抗細胞因子阻斷。當然，這是一種極佳的疾病機制。但是，添加 T 細胞調節劑——它有望（我強調這個詞）實現長期免疫正常化——顯然在討論中非常有吸引力。

You are right to call out the importance of being more data-driven. And of course, we've consistently shown the difference between this molecule that has a Q4 and Q12 dosing optionality, which means down to after loading dose four injections a year, which not only provides optionality for patients, but also site of injection, et cetera, which will matter, I'd also like to -- both of those are really important.

你強調數據驅動的重要性，這點非常正確。當然，我們已經持續證明了這種分子與 Q4 和 Q12 給藥方案之間的區別，這意味著在負荷劑量後，每年只需注射四次，這不僅為患者提供了選擇，而且注射部位等也很重要，我也想說——這兩點都非常重要。

But I'd like to not only underline the importance of the mechanism and the optionality, but that this molecule remains aligned with our initial benefit-risk assessment, which is ever so important in this space, which is hugely biologically underpenetrated. And Brian, at the very beginning of the call, outlined the importance of having options for these patients in terms of therapeutics.

但我不僅想強調該機制和選擇性的重要性，而且想強調該分子仍然符合我們最初的收益-風險評估，這在這個生物滲透性極低的領域中非常重要。在通話一開始，布萊恩就強調了為這些患者提供多種治療方案的重要性。

So finally, you asked discussions with prescribers. We did many hundreds of interviews over the last couple of years, including at the recent meeting in Paris. And I can genuinely say that there's enthusiasm about a novel mechanism for action in this space. Thank you very much for the question.

最後，你詢問了與處方醫生的討論情況。在過去的幾年裡，我們進行了數百次採訪，包括最近在巴黎舉行的會議。我可以毫不誇張地說，大家對這領域的新作用機制充滿熱情。非常感謝您的提問。

Thank you. Next question.

謝謝。下一個問題。

Seamus Fernandez, Guggenheim.

西莫斯·費爾南德斯，古根漢美術館。

Thanks so much. So just a couple of questions. First one is on the kind of Kaposi sarcoma case that we saw. Can you provide a little bit more detail on that as it relates to amlitelimab? And is this on mechanism in your view, or is it more a reflection of the sort of specific patient profile in that particular case? And just wanted to confirm that there were no and have been no additional cases seen in the overall program for amlitelimab.

非常感謝。那麼，就問幾個問題吧。首先是關於我們所見到的卡波西氏肉瘤病例。您能否就阿米利單抗的相關情況提供更多細節？您認為這是一種機制，還是更反映了該特定病例中特定患者的特徵？我只是想確認一下，在整個 amlitelimab 計畫中，沒有出現過，也從來沒有出現過其他病例。

The second question is on lunsekimig. I think you made a comment at a conference earlier this year specifically that there's a contribution of -- that you believe there's a contribution of TSLP in some early atopic dermatitis data as it relates to lunsekimig. I was just hoping you could clarify and confirm that comment and your views and hope that lunsekimig in that formulation -- in that disease state could potentially have a role. Thanks.

第二個問題是關於lunsekimig的。我認為你在今年早些時候的一次會議上特別提到，你認為 TSLP 在一些早期異位性皮膚炎數據中與 lunsekimig 有關。我只是希望您能澄清並確認您的評論和觀點，並希望 lunsekimig 在這種疾病狀態下可能發揮一定作用。謝謝。

Okay. Houman?

好的。人類？

Yeah, thank you. Multiple parts of that question.

是啊，謝謝。這個問題包含多個部分。

Number one, let me do the second one first, just to very quickly take that off the table. Yes, there is existing data -- not with our molecule, but other people's molecules -- that TSLP may indeed have a therapeutic benefit in the treatment of atopic dermatitis. Obviously, IL-13 is well established in this space. The combination of TSLP and IL-13 indeed may have an additive or indeed synergistic effect. We are testing that clinical hypothesis will be very data-driven. So we look forward to seeing the results of lunsekimig, not only in asthma and its related adjacencies, but also in atopic dermatitis.

首先，讓我先解決第二個問題，快速排除這個問題。是的，已有數據（不是我們研發的分子，而是其他人研發的分子）表明，TSLP 可能確實對治療異位性皮膚炎有治療作用。顯然，IL-13 在這一領域已得到充分證實。TSLP 和 IL-13 的組合確實可能具有疊加效應，甚至是協同效應。我們正在檢驗臨床假設是否高度依賴數據。因此，我們期待看到 lunsekimig 的療效，不僅在氣喘及其相關疾病方面，而且在異位性皮膚炎方面。

And then as you outlined in the amli question on Kaposi sarcoma, the answer to your question is that all immunomodulators come with a theoretical risk of infectious complications or increased infectious risk. Kaposi sarcoma unequivocally is caused by a herpesvirus, HHV-8, a standard herpesvirus. And it's not surprising that a herpesvirus would be associated with an immunomodulator, as they are with all other immunomodulators. There is some genetic evidence to suggest perhaps that with amlitelimab, there may be a differential sensitivity to some or other of the herpesviruses.

正如你在關於卡波西氏肉瘤的amli問題中概述的那樣，你的問題的答案是，所有免疫調節劑都存在理論上的感染併發症風險或增加感染風險。卡波西氏肉瘤毫無疑問是由皰疹病毒 HHV-8（一種常見的皰疹病毒）引起的。皰疹病毒與免疫調節劑相關並不奇怪，因為它們與其他所有免疫調節劑都有關聯。有一些遺傳證據表明，使用氨利利單抗治療時，患者可能對某些皰疹病毒有不同的敏感性。

So as you say, potentially our mechanism, the very first IB that we put out before we ever started the Phase 3s, this was anticipated and was not regarded as a significant issue of concern. The benefit-risk profile with this molecule is in line with everything we've said. And as is our activity, we will continue to produce not just with Kaposi sarcoma, but all the broader safety and benefits of this molecule as we continue to publish the data sequentially until the end of the OCEANA studies.

正如你所說，我們可能採取的機制，也就是我們在開始 3 期臨床試驗之前發布的第一個 IB，是預料之中的，並且沒有被視為一個值得關注的重大問題。該分子的獲益風險比與我們先前所說的完全一致。正如我們一貫的做法，我們將繼續研究該分子在治療卡波西氏肉瘤方面的療效，並隨著 OCEANA 研究的進行，陸續公佈相關數據，以進一步闡明該分子的安全性和益處。

Thank you. Next question, please.

謝謝。下一個問題。

David Risinger, Leerink.

David Risinger，Leerink。

Yes, thanks very much. So congrats on the fourth-quarter performance. I just have a couple questions. First, Houman, in terms of the amlitelimab press release that you issued recently, when do you expect to disclose full results from those studies?

是的，非常感謝。恭喜你們第四季的出色表現。我只有幾個問題。首先，侯曼，關於您最近發布的關於amlitelimab的新聞稿，您預計何時公佈這些研究的完整結果？

And François, business EPS is expected to grow faster or slightly faster than sales this year, despite losing R&D reimbursement from Regeneron during the third quarter. Could you just talk about the offsets to that and, looking forward to 2027, how you're thinking about prospects for growth and earnings as well? Thank you.

弗朗索瓦表示，儘管第三季失去了 Regeneron 的研發報銷，但預計今年的業務每股收益成長速度將超過或略高於銷售額成長速度。您能否談談這方面的抵銷因素，以及展望 2027 年，您如何看待成長和獲利前景？謝謝。

Thanks, David. Houman?

謝謝你，大衛。人類？

Yeah, quick answer to your question. I think we committed to presenting the COAST 1 data at AAD, which I think is at the end of March in Denver this year, subject to the conference organizers' clement nature. We may be able to put COAST 2 and SHORE in there. That's still subject to discussion. So we hope to be able to present most of the data to you by the end of March.

好的，簡單回答你的問題。我認為我們已經承諾將 COAST 1 數據提交給 AAD，我認為 AAD 將於今年 3 月底在丹佛舉行，但這取決於會議組織者的寬容態度。我們或許可以把 COAST 2 和 SHORE 也放進去。這仍有待討論。因此，我們希望能在三月底之前向您展示大部分數據。

Okay, thank you. François?

好的，謝謝。弗朗索瓦？

Yes. David, as far as 2026 is concerned, to start with, indeed you mentioned it, we will have a decrease of the R&D reimbursement by Regeneron of EUR400 million this year. It was initially thought it would be EUR300 million, but since Dupixent is growing fast, even faster than we thought, we will accelerate this determination of the reimbursement earlier.

是的。David，就 2026 年而言，首先，正如你所提到的，今年 Regeneron 的研發報銷將減少 4 億歐元。最初預計報銷金額為 3 億歐元，但由於 Dupixent 的成長速度很快，甚至比我們預想的還要快，我們將加快確定報銷金額的進程。

So we have a negative impact of EUR400 million this year, but it will be more than offset by the Amvuttra royalties, which are going to increase even further than we thought. So we had almost EUR0.5 billion of Amvuttra royalties in '25. It will be probably around EUR1 billion in '26. So we'll have a net between the two items in terms of impact on the BOI of about positive EUR100 million this year in '26.

因此，我們今年將受到 4 億歐元的負面影響，但 Amvuttra 的特許權使用費將遠遠抵消這一影響，而且這些特許權使用費的增長幅度甚至會超過我們的預期。因此，我們在 2025 年獲得了近 5 億歐元的 Amvuttra 特許權使用費。到 2026 年，可能約為 10 億歐元。因此，這兩個因素對愛爾蘭銀行的影響淨額將在 2026 年達到約 1 億歐元。

In '27, we had initially thought that we would have the full impact of the termination of the R&D reimbursement by Regeneron. We expected initially that it would be a decrease of BOI of about EUR800 million in '27. It will be a bit less probably with what we see today around EUR700 million as a consequence of what I said earlier.

2027 年，我們最初認為 Regeneron 終止研發報銷將對我們產生全面影響。我們最初預計 2027 年 BOI 將減少約 8 億歐元。正如我之前所說，今天我們看到的7億歐元左右的可能性會略低一些。

On Amvuttra, it should be probably around -- it's still early to say, but a further increase of EUR300 million. So the net between the two will be probably a negative in '27 at BOI level of minus EUR400 million, which is a bit better than what we had said last time.

Amvuttra 方面，金額應該在 3 億歐元左右——現在下結論還為時過早，但可能會進一步增加 3 億歐元。因此，到 2027 年，兩者之間的淨額可能會為負值（以愛爾蘭銀行的計算），為 -4 億歐元，這比我們上次所說的要好一些。

Okay, thank you. Next question, please.

好的，謝謝。下一個問題。

Simon Baker, Redburn.

西蒙貝克，雷德本。

Thank you for taking my questions. Two if I may, please. Firstly, one for Houman, you've had a bit of a rationalization of your Phase 2 portfolio. I just wonder if you could talk us through any overarching principles that guided those decisions and future development plans.

謝謝您回答我的問題。如果可以的話，請給我兩個。首先，給侯曼一個建議，你的第二階段投資組合已經做了一些合理化調整。我想請您詳細介紹一下指導這些決策和未來發展計畫的整體原則。

And then secondly, moving on to Dupixent, the main patent goes in March '31. But as far as we can tell, you've got about 40 patents, which expire between late '31 and February 2045. So I just wonder if you could give us your thoughts on life after March '31 in terms of the potential LOE for Dupixent. Thanks so much.

其次，關於 Dupixent，其主要專利於 1931 年 3 月到期。但據我們所知，您擁有約 40 項專利，這些專利的到期時間介於 2031 年末至 2045 年 2 月之間。所以我想知道，您能否談談您對 2031 年 3 月之後 Dupixent 可能終止服務期限的看法。非常感謝。

Okay. Houman, we'll go to you and then, of course, quickly to Roy for his moment.

好的。侯曼，我們會先去訪問你，然後當然，也會很快去採訪羅伊，讓他有機會發言。

Thank you for the question. When I started 2.5 years ago, it was very clear that we'd have a dynamic allocation strategy. We are good stewards of capital and we need to ensure that every dollar is well spent. So the overarching strategy, which François and I hold hands on, is that we will, on a regular basis, now on at least quarterly basis, guided by AI, establishment of value, will dynamically reallocate resources.

謝謝你的提問。兩年半前我剛加入公司時，我們就非常清楚，我們將採取動態分配策略。我們是資金的良好管理者，我們需要確保每一分錢都花在刀刃上。因此，我和弗朗索瓦共同製定的整體策略是，我們將定期（現在至少每季一次）在人工智慧的指導下，透過建立價值，動態地重新分配資源。

And what that means is there'll be some programs that stop. But of course, it also means that we will double down on some programs and we'll do the right things, even if they're hard. So the overarching principle is very simply in relation of capital allocation to value.

這意味著有些項目將會停止。當然，這也意味著我們將加倍投入一些項目，我們將做正確的事情，即使這些事情很困難。因此，其整體原則非常簡單，就是資本配置與價值之間的關係。

Thank you. Roy?

謝謝。羅伊？

So Simon, thanks for the question. We do expect Dupixent to be protected by its patents beyond March '31 in the US. That's the reality. As you can imagine, lots of innovation, lots of indications and counting. These are being recognized by multiple, and thank you for going through them, granted and to be granted patents ranging from [39.5].

西蒙，謝謝你的提問。我們預計 Dupixent 在美國的專利保護期將持續到 2031 年 3 月後。這就是現實。正如你所想，有很多創新，很多跡象和統計數據。這些已獲得多項專利的認可，感謝您的閱讀，這些專利涵蓋範圍廣泛，包括已授予和即將授予的專利。[39.5]

We believe we have a very strong patent portfolio, which we intend to vigorously defend. You'll understand it's too early to speculate on specific dates or by similar entry. If and when patent fights commence, we'll be able to give you more details of what is being challenged and where, but we feel we're in a good place with multiple patents.

我們相信我們擁有非常強大的專利組合，我們將全力捍衛這些專利。你應該明白，現在就推測具體日期或類似情況還為時過早。如果專利糾紛爆發，我們將能夠向您提供更多關於被質疑的內容和地點等詳細信息，但我們擁有多項專利，感覺我們處於有利地位。

Okay. Thanks, Roy. Okay, next question, please.

好的。謝謝你，羅伊。好的，請問下一個問題。

Luisa Hector, Berenberg.

路易莎·赫克托，貝倫貝格。

Hi there. Thank you. I wanted to ask on vaccines, please. Because if we look at 2025, you deployed about EUR3 billion on business development, M&A. So I wondered if you're putting that together with your R&D, is that a significant step-up in capital allocation to vaccines? And how should we think about the opportunity cost versus building your drug pipeline?

你好呀。謝謝。我想問一下關於疫苗的問題。因為如果我們展望 2025 年，你們將在業務發展和併購方面投入約 30 億歐元。所以我想知道，如果您將這些投入與您的研發結合起來，這是否會大幅增加對疫苗的資金投入？我們該如何權衡建構藥物研發管線的機會成本？

And then perhaps a little more color on Dynavax, looks like a neat deal. So how did you value it? Is this a US opportunity mainly? Is it catch up and then you move to an annual cohort eventually? And should we think about shingles as a booster opportunity in the over 70s? Thank you.

然後或許可以再詳細介紹Dynavax，看起來很划算。那你是如何評估它的價值的？這主要是一個美國的機會嗎？是先進行補習，然後最後改為每年一次的集中授課嗎？我們是否應該將帶狀皰疹視為70歲以上族群的免疫增強機會？謝謝。

Thank you, Luisa. Thomas, two good questions for you.

謝謝你，路易莎。湯瑪斯，我有兩個好問題想問你。

So I will start in the reverse order with the age on mind. So on Dynavax, let me first start by saying that the transaction is not closed yet. So as you know very well, we're still processing. But going back to your question, I can talk a little bit about the rationale.

所以我會倒序開始，先從年齡說起。所以關於 Dynavax，首先我要說明的是，這筆交易尚未完成。正如您所知，我們仍在處理中。但回到你的問題，我可以稍微談談其中的理由。

A few elements I'd like to highlight on this. First of all, it goes very well with what we discussed before, with the fact that we are fairly present on a significant part of the pediatric immunization schedule. But as we discussed in the past, we see, in terms of demographics, simply an increase on the older adult group and decrease over the past few years on the pediatric. And that's why our strategy is more and more focused towards the older adult group in terms of pipeline development.

我想重點強調以下幾點。首先，這與我們之前討論的內容非常吻合，因為我們在兒科免疫接種計劃的大部分環節中都佔有相當大的比例。但正如我們過去討論過的，從人口統計數據來看，過去幾年老年人群體數量有所增加，而兒童群體數量有所減少。因此，我們在人才培養方面越來越注重老年人群。

And the Dynavax proposed acquisition very well fits that profile. We're (inaudible) mostly focused on the US, so that's really the cornerstone for this product. We have a very differentiated product, with a two doses regimen versus three doses for any other competitor. And you've seen the progress on the top of market share. And we believe by adding our commercial muscle there, we can further improve the performance in this segment.

而Dynavax提出的收購方案非常符合這項特色。我們主要（聽不清楚）關注美國市場，所以這才是這款產品的真正基石。我們的產品具有很強的差異化優勢，只需兩劑即可完成治療，而其他競爭對手的產品則需要三劑。您已經看到了市場佔有率的進展。我們相信，透過投入我們的商業力量，我們可以進一步提高該領域的表現。

In parallel, you have mentioned shingles, very interesting Phase 1/2 data there from the Dynavax shingles candidate. We believe there's a great possibility in terms of marketplace if there is a candidate that comes with a significant similar efficacy than the current incumbent in that place. However, with a much better tolerability, we believe that the Dynavax technology will enable that profile.

同時，您提到了帶狀皰疹，Dynavax 帶狀皰疹候選藥物的 1/2 期數據非常有趣。我們認為，如果出現一位候選人，其效果與該領域的現任者非常相似，那麼在市場上就有很大的機會。然而，我們相信，Dynavax 技術具有更好的耐受性，能夠實現這一目標。

Going back to the first part of your question on capital allocation, so if you look at it from the way you framed it, indeed, there has been an increase in 2025. But I'd like to maybe take a step back and explain to you how we look at it. We don't look at capital allocation or acquisition per tier. The way we look at it is what is the strategic fit of every single possibility in terms of acquisition or licensing it, does it fit our portfolio, does it fit our capabilities, does it fit our long-term perspective on the business.

回到你關於資本配置問題的第一部分，如果你從你提出的角度來看，確實，到 2025 年資本配置有所增加。但我或許想退一步，向你們解釋我們是如何看待這個問題的。我們不考慮按層級劃分的資本配置或收購情況。我們看待這個問題的方式是，從收購或授權的角度來看，每一種可能性在策略上是否契合，它是否符合我們的產品組合，是否符合我們的能力，是否符合我們對業務的長期願景。

We have a very strong long-term perspective on the vaccination business, where the fundamentals are very strong. We believe that the acquisitions we have made, both early and later stage in 2025, do reflect and do fit well that perspective. So we're not looking at it per tier, we're really looking at it. What's the strategic fit? Are we the best owners? Can we deliver significant added value? And if that's the case, at the right price, then we go for it.

我們對疫苗業務有著非常堅定的長期展望，而這項業務的基本面非常強勁。我們相信，我們在 2025 年早期和後期階段進行的收購，確實反映了這一觀點，並且與這一觀點非常契合。所以我們不是以層級來看這個問題，而是真正去看待它。戰略契合度如何？我們是最好的業主嗎？我們能否創造顯著的附加價值？如果價格合適，我們就買。

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

謝謝你，托馬斯。好的，請問下一個問題。

Pete Verdult, BNP.

Pete Verdult，BNP。

Yeah, thanks. Pete Verdult. I'll be impeding apologies if some of these questions have been asked, but we've had a rather long-winded investor call to finish off. So just two questions.

嗯，謝謝。皮特·維杜爾特。如果有些問題之前有人問過，我先在此致歉，因為我們剛結束了一場相當冗長的投資人電話會議。所以，我只有兩個問題。

Thomas, sorry to come to stay on vaccines, can we spend some time on the outlook in light of some of the recent developments that you've already touched upon, particularly in the US, and the context in terms of the EUR10 billion target you set for 2030? So just looking for a little bit of a ballpark reminder, what percentage of your business today is exposed to these US pediatric vaccination schedule changes? I know we're not expecting any imminent impact, but just to remind us what the ballpark exposure is, could you flesh out a bit more some of the US and ex-US Beyfortus dynamics?

Thomas，很抱歉又要談到疫苗問題了，鑑於您剛才提到的一些最新進展，特別是美國的進展，以及您設定的 2030 年 100 億歐元目標的背景，我們能否花些時間討論一下前景？所以，我只是想大概了解一下，目前貴公司有多少百分比的業務會受到美國兒童疫苗接種計劃變化的影響？我知道我們預計不會立即產生任何影響，但為了提醒我們大致的風險敞口，您能否再詳細說明美國和前美國貝福特圖斯的一些動態？

And then when it comes to flu, what's your sort of -- on a net basis, how are you thinking about the outlook? On one hand, you've got mRNA threats receding, but you've got investor concerns around risks from competitor preventative assets rising. So net-net, how are you thinking about flu? So that's the first question.

那麼說到流感，你整體上如何看待前景？一方面，mRNA威脅正在減弱，但另一方面，投資者對競爭對手預防性資產帶來的風險的擔憂正在上升。總的來說，你對流感有什麼看法？這是第一個問題。

And then much more succinctly, Paul or François, just on capital allocation, given the part of disappointments, is it fair to assume business development activity is set to accelerate significantly going forward? I realize you're not going to talk about specific assets, but just your intention to do BD, is that set to step change? Thank you.

那麼，保羅或弗朗索瓦，更簡潔地說，就資本配置而言，考慮到令人失望的部分，是否可以合理地假設業務發展活動將在未來大幅加速？我知道你不會談論具體的資產，但你打算進行業務拓展，這是否會帶來改變？謝謝。

Okay, thank you. Thomas and François?

好的，謝謝。托馬斯和弗朗索瓦？

Yeah. So welcome first, Pete. And indeed, there was a bit of a similar question at the front stage, so I'll be pretty fast.

是的。首先歡迎皮特。確實，前面也有人問過類似的問題，所以我長話短說。

So on the outlook about vaccines, and I think, to be clear and explicit, you're referring to the recent US childhood immunization recommendation changes in the US. Maybe a few words about this, and then we'll turn the page. So those recommendations, to be clear, have been pivotal in making sure that we can prevent life-threatening disease in US citizens for many, many decades.

所以關於疫苗的前景，我認為，明確地說，你指的是美國最近對兒童免疫接種建議的改變。或許可以簡單說幾句，然後我們就翻到下一頁。因此，需要明確的是，這些建議在確保我們能夠預防美國公民患有危及生命的疾病方面發揮了關鍵作用，這種情況已經持續了數十年。

The recent and sudden shift that has been in early January to a three-tiered childhood vaccination framework will generate confusion for both parents and providers. We don't know that. We don't know yet if there will be a concrete impact in terms of VCR. That's way too early to look at that.

1 月初突然將兒童疫苗接種框架改為三級制，將給家長和醫護人員帶來困惑。我們並不知道。我們目前還不清楚這會對錄影機產生什麼具體影響。現在考慮這個問題還為時過早。

A couple of points, though, in terms of dynamics I'd like to highlight. First of all, you've seen that every single medical society, and by far the very, very vast majority of HCPs, have decided to stick to the previous immunization schedule, first point. Second point, you have not missed the fact that all vaccines remain covered by insurance or by Medicaid or by Medicare, depending on the different products.

不過，就動態方面而言，我想強調幾點。首先，您已經看到，每一個醫學協會，以及絕大多數的醫護人員，都決定堅持先前的免疫接種計劃，這是第一點。第二點，您沒有忽略這樣一個事實：所有疫苗仍然由保險、醫療補助或醫療保險支付，這取決於不同的疫苗產品。

So it's not a question of coverage, but Pete, you're right, there could be some confusion in terms of US pediatric vaccination schedule. The way we look at it is, what can we do? And we are focused on our energy and our actions. We engage proactively with HCPs, with medical societies in every single country, US and non-US. We explain the benefits of our product, how they are differentiated from others, and we focus on what we can do. So that's really for the situation in the US.

所以這不是覆蓋範圍的問題，但皮特，你說得對，美國兒科疫苗接種計劃方面可能會有些混亂。我們看待這個問題的方式是，我們能做些什麼？我們專注於我們的精力和行動。我們積極主動地與醫療保健專業人員以及美國和非美國各國的醫學協會進行溝通。我們會解釋我們產品的優勢，它與其他產品的區別，並重點介紹我們能做什麼。所以，這主要指的是美國的情況。

You've mentioned a couple of things on Beyfortus, US, ex-US, we mentioned that in the call before. But as I was mentioning, happy about the '25 performance, 9.5% increase. '26, too early to say. We expect to give more guidance on this as we move forward in the year, probably at the Q2 earnings call. We then look at US, ex-US.

您提到了一些關於Beyfortus、美國、前美國的事情，我們之前在電話會議中也提到過。但正如我剛才提到的，我對2025年的表現很滿意，成長了9.5%。至於2026年，現在下結論還為時過早。我們預計會在今年晚些時候，可能在第二季財報電話會議上，就此給予更多指引。然後我們來看美國和前美國地區。

Your second point was on flu and how we look at the marketplace moving forward. You've seen that Q4 flu performance was significant. Maybe it's the opportunity for me to mention a couple of things. It's the second season in a row, two years in a row, two winters, where there has been a massive increase in terms of influenza hospitalization across the North Hemisphere, on this side of the Atlantic or on the other side, which is a very important reminder of the fact that these cases can be prevented pretty simply with a vaccination, including with differentiated flu vaccination.

您的第二點是關於流感以及我們如何看待未來的市場狀況。你已經看到第四季流感疫苗的投放效果非常顯著。或許我可以藉此機會提幾件事。這是連續第二個冬季，北半球（包括大西洋兩岸）流感住院人數大幅增加的季節，這再次提醒我們，這些病例可以透過接種疫苗（包括差異化流感疫苗）來輕鬆預防。

Happy about our 2025 performance, which ends up showing that our market share will increase, especially thanks to our differentiated flu products: Fluzone High-Dose, which has shown great data again this year clinically; as well as Flubloks you can take, very important differentiators moving forward. Obviously, this comes in a very specific situation, i.e., a decrease in terms of VCR in the US and a slight increase of influenza VCR in Europe, but you understand, from a value perspective, these are very different markets.

我們對自己 2025 年的表現感到滿意，最終結果顯示我們的市場份額將會成長，這尤其要歸功於我們差異化的流感產品：Fluzone High-Dose，該產品今年的臨床數據再次表現出色；以及可以服用的 Flubloks，這些都是未來非常重要的差異化優勢。顯然，這種情況發生在非常特殊的情況下，即美國VCR（疫苗接種率）下降，而歐洲流感VCR略有上升，但你應該明白，從價值的角度來看，這些是非常不同的市場。

Moving forward, we'll probably give some more guidance on flu at the Q2 earnings call. mRNA on flu is not a concern for us for 2026. It will not be present. It's not a concern for us in 2027, neither, simply because, as we discussed before, people are looking for the right profile in terms of efficacy and tolerability profile. So we think we are well positioned. We have the right products, more to come after the pre-booking season, so probably around the Q2 earnings call.

展望未來，我們可能會在第二季財報電話會議上提供更多關於流感的指導。 2026年，mRNA流感疫苗並非我們關注的重點。它不會出現。2027 年，這也不是我們擔心的問題，因為正如我們之前討論過的，人們都在尋找療效和耐受性方面都合適的產品。所以我們認為我們處於有利地位。我們有合適的產品，預售季結束後還會推出更多產品，大概會在第二季財報電話會議前後推出。

Thank you, Thomas. François?

謝謝你，托馬斯。弗朗索瓦？

Yes, Peter. On the capital allocation question, first and foremost, I presented it earlier. We have a strong balance sheet that gives us flexibility. That being said, we will remain very disciplined. So we will use our capital essentially around three criteria in terms of external growth, BD and M&A, strategic, essentially around our four existing main therapeutic area, plus potentially some white spaces. We want to make sure that we bring scientific differentiation and with best-in-class, first-in-class assets and differentiated assets, and we want to secure financial return as well.

是的，彼得。關於資本配置問題，首先，我之前已經提出過。我們擁有穩健的資產負債表，這使我們具備了靈活性。即便如此，我們仍將保持高度自律。因此，我們將主要圍繞三個標準使用我們的資本，即外部成長、業務拓展和併購、策略，主要圍繞我們現有的四個主要治療領域，以及一些潛在的空白領域。我們希望確保我們能夠帶來科學上的差異化，擁有業內最佳、一流的資產和差異化資產，同時我們也希望獲得財務回報。

We are certainly not chasing growth for the short and medium term. You saw our growth profile last year. You see our growth profile for 2026, which is at the upper end of the industry, so not chasing growth. But we are rather focusing on the longer term to complement our pipeline. So we have a certain number of assets in our pipeline.

我們當然不會追求短期和中期成長。您去年已經看過我們的成長概況。您可以查看我們 2026 年的成長概況，該概況處於行業高端水平，因此我們並非在追求成長。但我們更注重長期發展，以完善我們的產品線。所以我們目前有一定數量的項目正在籌備中。

We know as well that we have, we discussed it a few minutes ago, to manage the LOE of Dupixent at the earliest in 2031. We just discussed it. So as a consequence of that, we will try to focus essentially on Phase 1, Phase 2 assets, which is our priority. We could as well, as we did last year, by the way, complement it with commercialized assets, which will probably to a certain extent mitigate the BOI/EPS impact.

我們也知道，我們幾分鐘前討論過，最早也要到 2031 年才能控制 Dupixent 的 LOE。我們剛才討論過這個問題。因此，我們將主要集中精力於第一階段和第二階段的資產，這是我們的首要任務。順便說一句，我們也可以像去年一樣，用商業化資產來補充它，這可能會在一定程度上減輕 BOI/EPS 的影響。

Anyway, we will remain very disciplined. And I would not say we have time, because time flies and we have a feeling of urgency. But once again, we will be super focused and super disciplined.

總之，我們會保持高度自律。我不會說我們還有時間，因為時間飛逝，我們感到時間緊迫。但是，我們將再次保持高度專注和高度自律。

Thank you. Next question, please.

謝謝。下一個問題。

Steve Scala, TD Cowen.

史蒂夫·斯卡拉，TD Cowen。

Thank you so much. Two questions, please. First, I'm curious why Sanofi has not been as forthcoming as Regeneron on Dupixent life cycle extension programs. I'm referring specifically to what Regeneron shared earlier this month. My understanding is that you have similar rights as you do now. So are you simply not as confident in those programs? So that's the first question.

太感謝了。請問兩個問題。首先，我很好奇為什麼賽諾菲在Dupixent生命週期延長專案方面沒有像Regeneron那樣坦誠。我指的是Regeneron公司本月稍早分享的資訊。我的理解是，你享有的權利與現在基本相同。所以你對這些程序沒有那麼大的信心嗎？這是第一個問題。

Second question is, in the past -- in past quarters, Sanofi has noted on the Dupixent slide that Dupixent was number one in new to brand RX and number one in total brand share in the US. Curious why that was left off this quarter. Is that due to competition specifically from Ebglyss? Thank you.

第二個問題是，在過去的幾個季度裡，賽諾菲在Dupixent的幻燈片中指出，Dupixent在美國新藥處方藥和品牌總份額方面均排名第一。很好奇為什麼這季沒有收錄。這是由於來自 Ebglyss 的競爭造成的嗎？謝謝。

Okay. Brian, two questions for you.

好的。布萊恩，我有兩個問題想問你。

I'll start with the second one. Steve, thanks. That's a really nice setup. Sorry, we missed that on the slide. We are number one. We remain number one in every single indication across each of our specialists. So apologies. I think we are now adding more things about new indications and whatnot. We probably left that off there. But no, and I don't foresee that changing anytime soon.

我先從第二個開始。史蒂夫，謝謝。這套設備真不錯。抱歉，投影片漏掉了這一點。我們是第一。我們所有專家在所有指標上都保持第一名。所以，我深表歉意。我認為我們現在正在添加更多關於新適應症等方面的內容。我們可能漏掉了那部分。不，而且我預計這種情況短期內不會改變。

Now, as it relates to LCM and forthcomingness from a Regeneron standpoint, I'll build on what Roy said. First, it starts with our IP. First, you have to think about that. How are we going to continue to defend that long into the future? And so Roy gave a statement there. So we've got quite some time.

現在，就 LCM 和 Regeneron 的坦率程度而言，我將補充 Roy 所說的內容。首先，要從我們的IP位址開始。首先，你得好好想想這個問題。我們如何在未來很長一段時間內繼續捍衛這個目標？於是羅伊在那裡發表了聲明。所以我們還有相當長的時間。

But we've been building along with the alliance and LCM strategy, as you would imagine, and we will reveal it in due course. Most likely the first half of this year, you'll get an update on where we stand as far as what we're doing with Dupixent specifically. Might be formulation related, so on and so forth, but you'll get a bit of an update there as well.

但正如你所料，我們一直在與聯盟和 LCM 策略同步發展，我們將在適當的時候公佈。今年上半年，我們很可能會向大家報告我們在 Dupixent 計畫的具體進展。可能與配方有關等等，但你也會得到一些更新資訊。

Additionally, we're working on the next-generation IL-4Ra with Regeneron. Regeneron talked about this a little bit at JPMorgan, but we continue to work on and collaborate on programs that we have across the alliance. And again, that could be really meaningful as a follow-on Dupixent and so on and so forth. But beyond that, given our success across the alliance for quite some time now, we're always open to and interested in considering future collaborations with Regeneron, as we said, at JPMorgan. So I feel like we're in a really good spot right now. More to come in the very near future.

此外，我們正在與 Regeneron 合作開發下一代 IL-4Ra。Regeneron 在摩根大通會議上稍微談到了這一點，但我們會繼續在整個聯盟範圍內開展合作項目。而且，這可能對後續的 Dupixent 等藥物產生非常大的影響。但除此之外，鑑於我們與聯盟在相當長的一段時間內取得的成功，正如我們在摩根大通所說，我們始終對與 Regeneron 的未來合作持開放態度並感興趣。所以我覺得我們現在處境非常好。更多內容將在不久的將來發布。

Thank you, Brian. Next question.

謝謝你，布萊恩。下一個問題。

Sachin Jain, BofA.

Sachin Jain，美國銀行。

Hi there. Just two questions. Firstly, big picture, I guess, for Paul, there's a sentence in the press release that talks about midterm profitable growth of five years. And at a recent conference, you talked about potentially delivering, I guess, implied versus teens EPS. So just a big picture from your side, what was the intent on that signaling, giving consensus as large of their X pipeline? So just thoughts as to inserting that commentary within the debate for investors.

你好呀。就兩個問題。首先，從大局來看，我想，對保羅來說，新聞稿中有一句話提到了五年的中期獲利成長。在最近的一次會議上，您談到了可能會實現，我猜是隱含的每股盈餘（EPS），而不是十幾美元的每股盈餘。那麼，從你們的角度來看，發出該訊號的目的是什麼？是為了讓盡可能多的人認同他們的 X 管道嗎？所以，我只是想就如何將這段評論融入與投資者的討論中提出一些想法。

And then secondly, one from Houman, do we get any further TL1A Phase 2 data through the course of '26 that further profiles the asset as we start looking at that Phase 3 data, I guess, into '28? Thank you.

其次，侯曼先生，我們能否在 2026 年獲得更多關於 TL1A 第二階段的數據，以便在我們開始研究第三階段數據（我猜是到 2028 年）時進一步了解該資產的情況？謝謝。

And Sachin, maybe François comment first on profitable growth.

薩欽，或許弗朗索瓦會先就獲利成長發表意見。

Yes, profitable growth. I think that included that comment in the press release, because we had a lot of questions. We just wanted to make sure that the market understand that we do expect to deliver an attractive level of growth to start with for the next six, potentially eight years, who knows, and that this will be coming with profitable growth as well.

是的，獲利成長。我認為新聞稿中已經包含了那條評論，因為我們有很多問題。我們只是想確保市場明白，我們預計在未來六年，甚至可能八年內（誰知道呢），我們將實現一個有吸引力的增長水平，而且這種增長也將是盈利性的。

Because there was a question a couple of quarters ago about our capacity to deliver profitable growth each and every single year -- I confirmed it a little bit earlier today -- there was a question more specifically about '27, given the end of the R&D reimbursement with Regeneron, but it's not a defensive move, just a confirmation of the way that we see the outlook for the medium term.

因為幾個季度前有人質疑我們能否每年都實現盈利增長——我今天早些時候也稍微確認了一下——鑑於與 Regeneron 的研發報銷終止，有人更具體地質疑 2027 年的情況，但這並不是一個防禦性舉措，只是確認了我們對中期前景的看法。

Thank you. And your second question, the answer is simply yes, we will have maintenance data, the TL1A at some point this half.

謝謝。至於你的第二個問題，答案很簡單，是的，我們將在本半年的某個時候提供 TL1A 的維護資料。

Thank you. Next question.

謝謝。下一個問題。

James Gordon, Barclays.

詹姆斯·戈登，巴克萊銀行。

Hello. James Gordon from Barclays. Thanks for taking the questions. One question was on business development. I know you've had some questions on this already, but a follow-up to those, please. I've seen some attributive comments this morning about the company having a EUR14 billion to EUR15 billion BD firepower amount for this year.

你好。巴克萊銀行的詹姆斯‧戈登。謝謝您回答問題。其中一個問題是關於業務拓展的。我知道之前已經有人問過你一些相關問題，但請你再做個後續說明。今天早上我看到一些評論說，該公司今年的BD資金規模為140億至150億歐元。

And assuming that is right -- that was the comment -- what is the thinking there? Is it that you do -- you could really fire that immunology to get more assets, a good compliment or follow-on from Dupi, or with immunology looking a bit crowded and you've got a lot going on in immunology anyway, or already a bit more competition coming as well. Could you focus beyond Dupi and say, right, we're going to broaden out other areas of the business? So could it be like EUR15 billion on one big deal? And if so, is it more likely to be trying to do even more immunology or could you diversify?

假設這是正確的——這就是評論的內容——那麼他們的想法是什麼？是不是因為你真的想——你可以大力發展免疫學，以獲得更多資產，獲得 Dupi 的良好補充或後續支持，或者免疫學領域看起來有點擁擠，而你無論如何在免疫學領域都有很多事情要做，或者已經有一些競爭即將到來。您能否跳出 Dupi 的局限，說：“好的，我們要拓展業務的其他領域？”所以，會不會是一筆價值 150 億歐元的大交易呢？如果是這樣的話，更有可能是繼續深入研究免疫學，還是會進行多元化發展？

And the second one I was just going to say as well, so it was efdoralprin alfa, if I call it, for AAT. I didn't see an update in the regulatory plans. Have you not spoken to the FDA? Or if not, when will you and do you think you can file on the data you've got? Thanks.

第二個我正要說，那就是用於治療 AAT 的 efdoralprin alfa（如果我這麼稱呼它的話）。我沒有看到監管計劃方面的更新。你沒有聯絡過美國食品藥物管理局（FDA）嗎？或者，如果不是，什麼時候可以提交？你認為你能根據你掌握的數據提交嗎？謝謝。

Why don't we go to François then Houman.

我們為什麼不先去找弗朗索瓦，然後再去找侯曼呢？

No, I will let just -- I will answer on the EUR15 billion, which is, I would say the upper limit of what we can do to maintain our (inaudible) So it has nothing to do with where we can invest by TA and so forth. As I said, I mean, we are interested predominantly in strengthening -- our position is not enough for existing TAs plus potentially white spaces. We could always contemplate going further than that. But the EUR15 billion was the technical limitation to preserve of (inaudible).

不，我只會——我會回答關於150億歐元的問題，我認為這是我們維持（聽不清楚）所能做的上限。所以這與我們透過技術評估等方式投資哪裡無關。正如我所說，我的意思是，我們主要感興趣的是加強——我們目前的地位不足以填補現有的助教和潛在的空缺。我們當然可以考慮更進一步。但150億歐元是維持現狀的技術限制。（聽不清楚）

Thank you. Houman?

謝謝。人類？

Yeah, I'll follow. Brian, thank you for this setup. We had excellent data as we announced late last year. We'll imminently, certainly this half of the year, go to the FDA to have broader conversations on the trajectory of that molecule, as we'd previously suggested. Thanks for the question.

好的，我會關注。布萊恩，謝謝你提供的這些設備。正如我們去年底宣布的那樣，我們掌握了非常好的數據。我們將很快，肯定在今年下半年，前往 FDA 就該分子的發展軌跡進行更廣泛的討論，正如我們之前建議的那樣。謝謝你的提問。

Okay. I think this is the final question, or at least next question.

好的。我認為這是最後一個問題，或至少是下一個問題。

James Quigley, Goldman Sachs.

James Quigley，高盛集團。

Perfect. Thank you for my questions. I've got two, please. Hopefully they haven't already been asked, but I'll give it a go anyway. So firstly, following on from Steve's question on the Regeneron portfolio, the IL-13 assets were not in the alliance. So was that a Sanofi decision? So is it that you think lunsekimig is more attractive option for IL-13? Can you give us any color yet as to why you're excited about the IL-13 and TSLP combination for lunsekimig?

完美的。謝謝你提出的問題。我要兩份。希望他們還沒被問過這個問題，但我還是想問。首先，接續 Steve 關於 Regeneron 產品組合的問題，IL-13 資產不在該聯盟內。所以這是賽諾菲的決定嗎？所以你認為 lunsekimig 是 IL-13 更具吸引力的選擇嗎？您能否透露一下您為何對 IL-13 和 TSLP 組合用於治療 lunsekimig 感到興奮？

And then secondly, on the haemophilia portfolio, Altuviiio continues to show strong growth. What are your expectations here into gaining additional share into 2026? Are you willing to give a peak sales forecast here now that you've hit blockbuster status? And also for Qfitlia, the launch is progressing steadily. You've got China approval now. So what's the feedback been in terms of where Qfitlia is being used? Are there any lingering thrombosis concerns with the product that may be holding it back? Thank you.

其次，在血友病產品組合方面，Altuviio 持續保持強勁成長動能。您對 2026 年獲得更多市佔率有何預期？既然你們已經取得了票房佳績，能否在此給出銷售高峰期的預測？此外，Qfitlia 的發布也在穩步進行中。你現在已經獲得中國的批准了。那麼，Qfitlia 的應用領域有哪些回饋呢？該產品是否存在任何潛在的血栓形成隱患，阻礙了其市場推廣？謝謝。

Okay. Thank you so much. Okay, Brian, over to you.

好的。太感謝了。好了，布萊恩，該你了。

Yeah. James, thanks so much for the question. I briefly addressed it just before. So it's not a decision necessarily on the IL-13. I think we talked about this a little bit at JPMorgan not so long ago.

是的。詹姆斯，非常感謝你的提問。我剛才已經簡要地提過了。所以這不一定是對IL-13的決定。我想不久前我們在摩根大通也稍微討論過這個問題。

But as I said before, we are not in the alliance currently, but we're always open to having conversations with Regeneron about potentially including it in the alliance. As I also said, we had a long acting IL-4Ra that actually is in the alliance that we're actually working on right now as a follow on asset to dupilumab. So again, long withstanding, great partnership with Regeneron. So we'll always have conversations with them about what we might do next together.

但正如我之前所說，我們目前還沒有加入聯盟，但我們始終願意與 Regeneron 就將其納入聯盟的可能性進行對話。正如我之前所說，我們有一種長效 IL-4Ra，它實際上是我們目前正在合作開發的，作為 dupilumab 的後續資產。所以，再次證明我們與 Regeneron 之間有著長期且良好的合作關係。所以我們會一直和他們討論接下來我們可以一起做些什麼。

As it relates to Qfitlia, you want me to tackle the Qfitlia one next. Qfitlia is -- again, it's still early days as far as the launch goes. We said from the very beginning, this is really very cool therapy in the sense that it is very targeted, kind of precision medicine, if you will, comes with a diagnostic as it relates to antithrombin levels. And again, what we said is we'll have a little slower ramp. I think it'll be a lot stickier on the back end from a patient standpoint as physicians get really -- they can dial it up and dial it down as a patient presents and as it's really more personalized by each patient.

至於 Qfitlia，您希望我接下來處理 Qfitlia 的問題。Qfitlia 目前仍處於發布初期階段。我們從一開始就說過，這是一種非常酷的療法，因為它非常有針對性，可以說是精準醫療，它還附帶了與抗凝血酶水平相關的診斷。我們再次強調，我們會採取更緩慢的加速策略。我認為從患者的角度來看，後期治療會更加複雜，因為醫生可以根據患者的病情調整治療方案，使治療更加個人化。

So far, we've heard really good feedback from the marketplace. No concerns as far as safety goes so far. But again, it's early days and promising. We'll keep you up to date in future calls.

目前為止，我們收到了來自市場的非常好的回饋。就目前而言，安全方面沒有任何問題。但話說回來，現在還處於早期階段，前景可期。我們會在以後的電話中向您通報最新情況。

Okay. Thanks, Brian. And then I think there may be one more.

好的。謝謝你，布萊恩。然後我覺得可能還有一個。

Graham Parry, Citi.

格雷厄姆·帕里，花旗銀行。

Great. Thanks for squeezing me in, and apologies if it has been answered. I think it has. I just want to check on itepekimab. You're saying about looking at additional data for the path forward. So can you give us timelines on what it is you're looking on the data and the clarity and timelines on path forward for that molecule?

偉大的。感謝您抽出時間接待我，如果這個問題之前已經有人問過，我深感抱歉。我認為有。我只是想了解伊替皮單抗的情況。你是說要查看更多數據，以建立前進方向。那麼，您能否提供您正在研究的數據的具體時間安排，以及該分子未來研究方向的清晰度和時間表？

And then tolebrutinib in the US, we just correct to assume no path forward in the US. If you could just comment on rest-of-world regulators' attitudes to the ability to monitor compared to the US, that'd be very useful. Thank you.

至於托布替尼在美國的情況，我們只能假設它在美國沒有發展前景。如果您能就世界其他地區監管機構對監管能力的態度與美國監管機構的態度進行比較，發表一些看法，那就太好了。謝謝。

Graham, at Citi, and those that will know know I had made that point. Thank you for the question. The first question -- let me do it in reverse. Tolebrutinib's approach is pretty straightforward. We're waiting for regulatory comments from rest of world, as you say, from EU. And we'll see where we take it from that.

花旗銀行的葛拉漢以及那些了解內情的人都知道我曾經表達過這一點。謝謝你的提問。第一個問題──讓我反過來問。Tolebrutinib 的作用機轉相當直接。正如您所說，我們正在等待世界其他地區，特別是歐盟的監管意見。接下來我們再看看情況如何發展。

And then on itepekimab, as I've consistently said, the next steps for itepekimab will be determined by interactions with the FDA predominantly to establish exactly the requirements for a replication study for Phase 3 going forward as soon as we know we will commit to sharing it more broadly in partnership with our successful alliance partners, Regeneron.

至於itepekimab，正如我一直所說，itepekimab的下一步發展將主要取決於與FDA的互動，以確定未來3期複製研究的具體要求。一旦我們確定了這些要求，我們將與我們成功的聯盟夥伴Regeneron合作，更廣泛地分享這些資訊。

Okay. Thank you, Houman. Thank you, Graham. Well, thanks for this last question.

好的。謝謝你，侯曼。謝謝你，格雷厄姆。謝謝你提出的最後一個問題。

In 2025, we achieved a strong year of profitable growth, sales increased by 9.9% with constant exchange rates, while business EPS improved significantly faster by 15%. We launched three new medicines and vaccines: Qfitlia, Wayrilz, and Nuvaxovid. All this was made possible by the dedicated effort of all Sanofi colleagues worldwide.

2025 年，我們實現了強勁的獲利成長，銷售額以固定匯率計算成長了 9.9%，而業務每股盈餘成長速度更快，達到了 15%。我們推出了三種新藥和疫苗：Qfitlia、Wayrilz 和 Nuvaxovid。這一切都離不開賽諾菲全球全體同事的辛勞。

In 2026, we expect sales to grow by a high-single-digit percentage and business EPS to grow slightly faster than sales. We anticipate profitable growth to continue over at least five years. Based on our pipeline, combined with external growth opportunities, our ambition is to pursue earnings growth into the next decade.

預計到 2026 年，銷售額將以接近兩位數的百分比成長，而企業每股盈餘 (EPS) 的成長速度將略高於銷售額的成長速度。我們預計獲利成長將至少持續五年。基於我們的產品線，加上外部成長機會，我們的目標是在未來十年內實現獲利成長。

With this, I would like to thank you for the interest in Sanofi and will now close the call. Thank you.

在此，我感謝各位對賽諾菲的關注，電話會議到此結束。謝謝。