Sanofi SA (SNY) 2025 Q3 法說會逐字稿

Hello, everyone. This is Thomas Kudsk Larsen from the Sanofi IR team. Welcome to the Q3 2025 conference call for investors and analysts. As usual, you can find the 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年第三季投資者和分析師電話會議。像往常一樣，您可以在 sanofi.com 上找到這些幻燈片。

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 that 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 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 usually in millions of euros, and for Q3 2025, only as we state 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。所用數字通常以百萬歐元為單位，並且僅適用於 2025 年第三季度，除非另有說明。

Please turn to slide number 4. First, we have the presentation, and then we take your questions. (Event Instructions) For 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. (Event Instructions)

請翻到第4張投影片。首先，我們會進行演示，然後回答大家的問題。（活動說明）問答環節，我們將邀請 Olivier、Brian 和 Thomas 來介紹我們的全球業務，還有我們的總法律顧問 Roy 和製造與供應主管 Brendan。（活動須知）

With this, I'll hand you over to Paul on my left-hand side.

接下來，我把你交給左邊的保羅。

Thomas. Thank you, everyone for joining us today. Our growth momentum continued in Q3 with EUR12.4 billion in sales. Up 7% over last year's high base of comparison. Sales growth was primarily driven by our new launches and the performance of DUPIXENT, which reached EUR4 billion in quarterly sales for the first time.

托馬斯。感謝各位今天蒞臨。第三季度，我們的成長動能得以延續，銷售額達到124億歐元。與去年較高的基數相比，成長了7%。銷售成長主要得益於我們的新產品上市和DUPIXENT的優異表現，DUPIXENT的季度銷售額首次達到40億歐元。

After the third-quarter performance, we are confident in the business outlook for the remainder of the year and reiterate our full-year 2025 sales guidance. This positive outlook includes our expectations for the business in the US, our largest market by sales. We continue to work with the administration and policymakers in the US and around the world on policies that improve access to treatments, lower prices for patients, and improve health systems and protect science. Our recent announcement on the expansion of our patient affordability program, offering improved access to all our insulins is a great example of this work, which I'll discuss in a little more detail later in the presentation.

根據第三季的業績，我們對今年剩餘時間的業務前景充滿信心，並重申我們對 2025 年全年的銷售預期。這項積極展望包括我們對美國業務的預期，美國是我們銷售額最大的市場。我們繼續與美國和世界各地的政府和政策制定者合作，制定能夠改善治療機會、降低病患價格、改善健康系統和保護科學的政策。我們最近宣布擴大患者負擔能力計劃，為所有胰島素的獲取提供更便捷的途徑，這便是這項工作的一個很好的例證，我將在稍後的演講中更詳細地討論這一點。

Now, let me highlight the contribution of our new launches, which have been a significant driver of this quarter's strong performance. Our launches delivered EUR1.8 billion this quarter to more than 40% and now represent 15% of our total sales. To put this in perspective, our launches represent almost half of DUPIXENT sales this quarter, demonstrating their significant contribution to our growth.

現在，我想重點介紹我們新產品的推出，它們是本季業績強勁成長的重要驅動力。本季度，我們的新品上市為超過 40% 的市場帶來了 18 億歐元的收入，目前占我們總銷售額的 15%。從這個角度來看，我們本季推出的產品幾乎佔 DUPIXENT 銷售額的一半，這表明它們對我們的成長做出了重大貢獻。

We've strengthened our commercial portfolio with three new additions: Ayvakit, our medicine for both advanced and indolent systemic mastocytosis; the first Sanofi cells of NUVAXOVID, offering an important protein-based non-mRNA alternative for COVID-19 vaccination; and Wayrilz, our new BTK inhibitor designed as a multi-immune modulator. This innovative medicine provides a new option for patients with immune thrombocytopenia that extends beyond their platelet count needs to addressing quality of life burdens.

我們透過新增三款產品加強了我們的商業產品組合：Ayvakit，我們用於治療晚期和惰性系統性肥大細胞增生症的藥物；NUVAXOVID 的首批賽諾菲細胞，為 COVID-19 疫苗提供了一種重要的基於蛋白質的非 mRNA 替代方案；以及 Wayrilz，我們設計的新型 BTK 抑製劑，作為一種多免疫調節劑。這種創新藥物為免疫性血小板減少症患者提供了一種新的選擇，其作用不僅限於滿足血小板計數需求，還能解決生活品質方面的負擔。

We're seeing good attack across our portfolio of new medicines and vaccines. Beyfortus, which achieved blockbuster status last year in its first full year of sales, continues its expansion into new geographies. ALTUVIIIO is on track to reach blockbuster status this year, and Ayvakit to become our next blockbuster in 2026.

我們看到，我們所有新藥和疫苗都獲得了良好的市場迴響。Beyfortus 在去年上市第一年就取得了巨大的成功，並繼續向新的地區擴張。ALTUVIIIO 有望在今年成為票房大片，而 Ayvakit 將在 2026 年成為我們的下一部票房大片。

DUPIXENT has reached a new milestone this quarter, exceeding EUR4 billion in quarterly sales for the first time. More than 8 years after its initial launch in atopic dermatitis, we saw an increase of over 30% in the number of patients during the last 12 months. In the US, we've surpassed the EUR3 billion quarterly sales mark, maintaining leadership in both new and total prescriptions across established indications. Our launches in the recently approved indications: COPD, CSU, and BP are progressing as planned.

DUPIXENT 本季取得了新的里程碑，季銷售額首次突破 40 億歐元。在首次用於治療異位性皮膚炎 8 年多之後，在過去的 12 個月中，我們看到患者數量增加了 30% 以上。在美國，我們的季度銷售額已突破 30 億歐元大關，在已確立的適應症領域，無論是新處方還是總處方量，我們都保持著領先地位。我們在近期獲準的適應症（COPD、CSU 和 BP）的上市工作正按計劃進行。

Outside the US, sales grew 21%, exceeding EUR1 billion in the quarter. We continue our efforts to make DUPIXENT available to more patients helped by the positive CHMP recommendation for CSU in the EU and regulatory submission for CSU in children in the US and EU.

在美國以外，銷售額成長了 21%，本季超過 10 億歐元。我們繼續努力，讓更多患者能夠使用 DUPIXENT，這得益於歐盟 CHMP 對 CSU 的積極推薦，以及美國和歐盟針對兒童 CSU 的監管申請。

Turning to our vaccine business, Q3 sales were EUR3.4 billion. This performance compares to a high base in the previous year and reflects the competitive price pressure as well as the lower flu immunization rate in the US. A new highlight among our respiratory vaccines is the early start of NUVAXOVID, the only non-mRNA COVID-19 vaccine available in the US and from our collaboration with Novavax, while shipments of NUVAXOVID were delivered to -- in the US in September.

再來看我們的疫苗業務，第三季銷售額為 34 億歐元。這一業績與去年的高基數相比有所下降，反映了激烈的價格競爭壓力以及美國流感疫苗接種率的降低。我們呼吸道疫苗的新亮點是 NUVAXOVID 的早期上市，這是美國唯一可用的非 mRNA COVID-19 疫苗，也是我們與 Novavax 合作開發的疫苗。 9 月份，NUVAXOVID 的貨物已運抵美國。

In RSV, Beyfortus continues its impressive expansion of 20% this quarter are now available in 40 countries. As you may have seen in our press release this morning, we decided to discontinue our RSV toller program. While the safety profile was acceptable, the predetermined criteria for efficacy was not met in the planned futility analysis. The PPH and Booster franchise remains an important contributor to our vaccine business, with the performance in Q3, reflecting phasing in the first half of the year.

在 RSV 領域，Beyfortus 繼續保持著令人矚目的成長勢頭，本季成長了 20%，目前已在 40 個國家/地區上市。正如您今天早上在我們的新聞稿中可能看到的，我們決定停止 RSV 檢測計劃。雖然安全性尚可接受，但在計劃的無效性分析中，預定的療效標準​​並未達到。PPH 和 Booster 產品線仍然是我們疫苗業務的重要貢獻者，第三季的業績反映了上半年的分階段實施情況。

Sanofi has a proud legacy in flu vaccines, and we remain committed on bringing innovation to strengthen our leadership in flu and to provide better protection for patients. Our FLUNITY-HD study published in The Lancet last week demonstrated that our high-dose flu vaccine, Efluelda, known as Fluzone High-Dose in North America, provided superior protection versus standardized vaccine on the sometimes devastating consequences of flu.

賽諾菲在流感疫苗領域擁有引以為傲的歷史，我們將繼續致力於創新，以鞏固我們在流感領域的領先地位，並為患者提供更好的保護。我們上週在《柳葉刀》上發表的 FLUNITY-HD 研究表明，我們的高劑量流感疫苗 Efluelda（在北美被稱為 Fluzone High-Dose）在預防流感有時會造成的毀滅性後果方面，比標準疫苗提供了更優的保護。

Data showed an 8.8% reduction in pneumonia or flu hospitalizations and an important 32% reduction in laboratory confirmed flu hospitalizations versus standard dose vaccines. And we're expanding access to this beneficial protection with positive Phase 3 data that support a label update extending the age down to 50 years for the Efluelda/Fluzone High-Dose.

數據顯示，與標準劑量疫苗相比，肺炎或流感住院人數減少了 8.8%，實驗室確診的流感住院人數顯著減少了 32%。我們正在擴大這種有益保護的覆蓋範圍，積極的 3 期臨床試驗數據支持更新標籤，將 Efluelda/Fluzone 高劑量藥物的適用年齡擴大到 50 歲。

Looking ahead, we're advancing our flu pandemic preparedness for two programs while improving vaccination convenience with positive data on flu, COVID combination vaccines. These achievements underscore our commitment to delivering enhanced protection against respiratory viruses to more people worldwide.

展望未來，我們正在推進兩項流感大流行應對計劃，同時利用流感和新冠聯合疫苗的積極數據來提高疫苗接種的便利性。這些成就凸顯了我們致力於為全球更多人提供更強效的呼吸道病毒防護的決心。

In addition to our unwavering commitment, innovation and respiratory viruses, we are also steadfast in our commitment to improve patients' access to healthcare. Our Global Health Unit has reached a remarkable milestone: 1 million patients treated for non-communicable diseases across more than 40 lower middle income countries since 2021, putting us on track to reach 2 million patients by 2030. We trained over 27,000 healthcare workers and reached 4 million people through our partnership programs during the same period.

除了我們對呼吸道病毒的堅定承諾、創新和不懈努力之外，我們還堅定不移地致力於改善患者獲得醫療保健的機會。我們的全球健康部門取得了一項了不起的里程碑：自 2021 年以來，我們在 40 多個中低收入國家治療了 100 萬名非傳染性疾病患者，這使我們能夠在 2030 年達到 200 萬名患者的目標。在同一時期，我們培訓了超過 27,000 名醫護人員，並透過我們的合作計畫惠及了 400 萬人。

And we're not stopping there. In the US, we're expanding our Insulins Valyou Savings Program to ensure every American has access to our insulins at just $35 per month. This initiative builds on Sonafi's long-standing efforts to provide patients access to a reliable and affordable supply of critical medicines.

我們不會就此止步。在美國，我們正在擴大胰島素超值優惠計劃，以確保每個美國人都能以每月僅 35 美元的價格獲得我們的胰島素。這項措施建立在 Sonafi 長期以來致力於為患者提供可靠且價格合理的關鍵藥物供應的努力之上。

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

謝謝。現在我將把麥克風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. In Q3, our net sales grew by 7% at constant exchange rates. This growth was primarily driven by pharma and, more specifically, by immunology and recent launches. Our new launch is demonstrating a strong momentum with 41% sales growth, while DUPIXENT sales grew by 26% this quarter.

謝謝你，保羅，大家好。第三季度，我們的淨銷售額以固定匯率計算成長了7%。這一成長主要由製藥業推動，更具體地說是由免疫學和近期推出的產品推動。我們的新產品上市勢頭強勁，銷售額增長了 41%，而 DUPIXENT 本季的銷售額增長了 26%。

Vaccine sales were down primarily due to flu as expected. This decrease resulted from a combination of competitive price pressure mainly in Germany and lower vaccination rates. At published rates, net group sales increased by 2%, impacted by the negative foreign exchange effects. These solid results highlight our ability to drive growth against headwinds.

正如預期的那樣，疫苗銷量下降主要是由於流感疫情的影響。這一下降是由於德國等地的價格競爭壓力和疫苗接種率下降共同造成的。受匯率負面影響，以公佈匯率計算，集團淨銷售額成長了 2%。這些穩健的業績凸顯了我們克服逆境、推動成長的能力。

Our business gross margin increased by 2.3 percentage points this quarter with a continued improvement in product mix, enhanced by productivity gains. We now capture the full benefit of DUPIXENT improved manufacturing process, as well as the contribution from Ayvakit since the Blueprint closing in mid-July. As we move into 2026, the gross margin profile will return to its fundamental growth as a step-up from DUPIXENT C3 manufacturing transition is now complete.

本季度，隨著產品組合的持續改善以及生產效率的提高，我們的業務毛利率提高了 2.3 個百分點。我們現在充分受益於 DUPIXENT 改進的生產工藝，以及自 7 月中旬藍圖結束以來 Ayvakit 的貢獻。隨著我們進入 2026 年，毛利率將恢復到基本成長水平，因為從 DUPIXENT C3 製造過渡的升級階段已經完成。

Operating expenses grew by 6%, excluding the impact of the Blueprint acquisition, operating expenses grew by low single digit, highlighting our cost discipline. R&D expenses increased by 5%, broadly reflecting the underlying activity level. We continue to invest in sales and marketing to support our launches, and G&A costs were slightly down, in line with our objective to keep them broadly stable going forward. Other operating income and expenses are moving up, primarily due to the increased share of profit paid to Regeneron as DUPIXENT continues its strong growth trajectory.

營運費用成長了 6%，若不計入 Blueprint 收購的影響，營運費用將以較低的個位數成長，這凸顯了我們的成本控制能力。研發費用成長了 5%，大致反映了潛在的業務活動水準。我們繼續投資於銷售和行銷以支持我們的產品上市，一般及行政費用略有下降，這符合我們未來保持其整體穩定的目標。其他營業收入和支出也在增加，這主要是由於 DUPIXENT 繼續保持強勁的成長勢頭，支付給 Regeneron 的利潤份額增加所致。

Business EPS reached EUR2.91, a robust growth of EUR0.19 and 13% compared to Q3 2024. This strong performance reflect our compelling sales growth and increasing gross margin combined with cost discipline.

業務每股收益達 2.91 歐元，較 2024 年第三季強勁成長 0.19 歐元和 13%。這一強勁的業績反映了我們強勁的銷售成長和不斷提高的毛利率，以及嚴格的成本控制。

Looking at our year-to-date progress, we are maintaining strong earnings momentum, with 9% sales growth and business EPS growing faster at 12%. It fully supports our guidance for the full year and demonstrate our ability to deliver profitable growth consistently.

從今年迄今的進展來看，我們保持了強勁的獲利勢頭，銷售額成長了 9%，業務每股收益成長更快，達到 12%。這完全支持我們對全年的業績預期，並證明了我們持續實現獲利成長的能力。

Based on our year-to-date performance, we reiterate our full-year guidance of high single-digit sales growth and low double-digit business EPS growth at constant exchange rates. We have now completed the acquisitions of Dren Bio's DR-0201, Vigil Neuroscience, and Blueprint; and their associated costs are fully factored in our guidance.

根據我們今年迄今的業績，我們重申全年業績預期，即按固定匯率計算，銷售額將實現高個位數增長，業務每股收益將實現低兩位數增長。我們現已完成對 Dren Bio 的 DR-0201、Vigil Neuroscience 和 Blueprint 的收購；相關成本已完全計入我們的業績預期。

While we typically provide full-year guidance at the beginning of each year, we can share a few business trends for next year, which you may find useful for modeling purposes. R&D next year is expected to increase moderately. We will continue investing in sales and marketing to support our product launches, as well as our strong sales momentum.

雖然我們通常會在每年年初提供全年業績指引，但我們可以分享一些明年的業務趨勢，這些趨勢可能會對您進行建模有所幫助。預計明年研發投入將溫和成長。我們將繼續增加對銷售和行銷的投入，以支持我們的產品發布以及我們強勁的銷售勢頭。

At the same time, we will remain disciplined on G&A costs with the objective to keep them broadly stable. We expect to achieve around EUR0.5 billion of capital gains from divestments, similar to what we anticipate for 2025.

同時，我們將繼續嚴格控制一般及行政費用，目標是維持其整體穩定。我們預計透過資產剝離可獲得約 5 億歐元的資本收益，與我們對 2025 年的預期類似。

Regarding AMVUTTRA royalties, based on the latest evaluate pharma sales consensus, the implied royalties are not expected around EUR700 million for next year. You will find a slide with the updated AMVUTTRA royalty considerations reflecting current external consensus in the appendices of this presentation.

關於 AMVUTTRA 的特許權使用費，根據最新的評估製藥銷售共識，預計明年的隱含特許權使用費約為 7 億歐元。您可以在本簡報的附錄中找到一張投影片，其中反映了當前外部共識，更新了 AMVUTTRA 版稅考量。

Another indicator for 2026 is the reduction of approximately EUR300 million reimbursement from Regeneron for the R&D balance. Both item, AMVUTTRA gains and reduced Regeneron R&D reimbursement, will offset each other next year.

2026 年的另一個指標是 Regeneron 公司研發資金餘額的報銷額將減少約 3 億歐元。明年，AMVUTTRA 收益和 Regeneron 研發報銷減少這兩項因素將相互抵銷。

We continue to execute our capital allocation policy, and we remain disciplined and balanced across four priorities: investing in organic growth drivers pursuing, selective bolt-on acquisitions, maintaining our policy of progressive dividends, and executing opportunistic share buybacks. Based on our projected trajectory for 2026 and beyond. We remain confident in our ability to sustain our profitable growth momentum for the next few years.

我們繼續執行資本配置政策，並在以下四個優先事項上保持紀律性和平衡性：投資於內生成長驅動因素、選擇性地進行補充收購、維持漸進式分紅政策以及執行機會性股票回購。基於我們對 2026 年及以後的發展軌跡的預測。我們仍然有信心在未來幾年內保持獲利成長動能。

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. I'm pleased to share our Q3 pipeline achievements with progress in many programs. We received regulatory approvals for Wayrilz in the United States, and ITP and Tzield in China. Further, we received regulatory submission acceptances for DUPIXENT CSUN children in the US and in the EU. The FDA nominated Tzield for the new Commissioner's National Priority Voucher to speed up the review. Wayrilz' ATP were limited in Japan. And SARCLISA's subcutaneous was accepted globally in myeloma.

謝謝你，弗朗索瓦。我很高興與大家分享我們第三季在產品研發方面取得的成果，許多專案都取得了進展。我們在美國獲得了 Wayrilz 的監管批准，在中國獲得了 ITP 和 Tzield 的監管批准。此外，我們已收到美國和歐盟對 DUPIXENT CSUN 兒童的監管申請受理。FDA提名Tzield獲得新任局長國家優先券，以加快審查速度。Wayrilz 的 ATP 在日本受到限制。SARCLISA 的皮下注射劑已在全球範圍內被接受用於治療多發性骨髓瘤。

Our Phase 3 programs have delivered successful readouts, with amlitelimab meeting the primary endpoint in the Phase 3 study in atopic dermatitis dose 1 and Fluzone High-Dose in people 50 years and above. We also commenced dosing first patients in new Phase 3 studies, 1 of the 2 studies for Lunsekimig in COPD, and Wayrilz in sickle cell disease and warm autoimmune hemolytic anemia. Finally, Wayrilz is emerging as a multi-immune modulation platform in rare diseases with an approval in the US and a positive recommendation in the EU for ITP, multiple designations across new indications, further strengthening our rare disease portfolio.

我們的 3 期臨床試驗計畫取得了成功，amlitelimab 在 3 期異位性皮膚炎 1 劑量研究中達到了主要終點，Fluzone 高劑量在 50 歲及以上人群中也達到了主要終點。我們也開始對新的 3 期研究中的第一批患者進行給藥，其中一項研究是 Lunsekimig 用於治療 COPD，另一項研究是 Wayrilz 用於治療鐮狀細胞病和溫型自體免疫性溶血性貧血。最後，Wayrilz 正在成為罕見疾病領域的多重免疫調節平台，已在美國獲得批准，並在歐盟獲得 ITP 的積極推薦，並在多個新適應症中獲得認定，進一步加強了我們的罕見疾病產品組合。

Please turn to the next. Moving to dermatology. Amlitelimab met all primary and secondary key endpoints in the first Phase 3 study in AD. Data demonstrated clinically meaningful improvement in several measures of skin clearance. As an example, looking at the vIGA measure, the efficacy progressively increased and showed no plateau at 24 weeks.

請翻到下一頁。轉行到皮膚科。在首個針對異位性皮膚炎的3期臨床研究中，Amlitelimab達到了所有主要和次要終點。數據顯示，在多項皮膚清除指標上均取得了具有臨床意義的改善。例如，從 vIGA 指標來看，療效逐漸提高，在 24 週時沒有達到平台期。

Further, amlitelimab offers patient-friendly quarterly dosing. There were no new safety concerns identified in this study. OCEANA AD is a comprehensive program, including 5 Phase 3 studies in adults and adolescents, biologic-experienced patients, and across different geographies. We anticipate full data to report out throughout 2026.

此外，amlitelimab 提供方便患者的季度給藥方案。本研究未發現新的安全隱憂。OCEANA AD 是一項綜合性計劃，包括 5 項針對成人和青少年、有生物製劑使用經驗的患者以及不同地區的 3 期研究。我們預計將在 2026 年全年公佈全部數據。

Brivekimig, our TNF alpha and OX40 ligand nanobody achieved its primary objective in a Phase 2a study in HS. We observed clinically meaningful improvements in both primary and secondary endpoints and biologically-naive patients at week 16. Brivekimig was well tolerated. Data were presented at EADV in Paris in September, where I also had the pleasure to meet many of you at our IR roundtable. Our Phase 2b study is now starting its recruitment.

我們的 TNF α 和 OX40 配體奈米抗體 Brivekimig 在 HS 的 2a 期研究中達到了其主要目標。在第 16 週，我們觀察到主要終點和次要終點以及生物學初治患者均有臨床意義的改善。布里夫基米格耐受性良好。9 月在巴黎舉行的 EADV 會議上，我們展示了相關數據，同時我也很高興在我們的投資者關係圓桌會議上見到了你們中的許多人。我們的 2b 期研究現在開始招募受試者。

Please turn to the next slide. Moving to respiratory, amlitelimab has shown intriguing efficacy in its Phase 2 study in asthma, particularly in a difficult-to-treat subgroup, while the primary endpoint of annualized asthma exacerbation rate reduction at week 48 did not reach statistical significance at the highest dose. Notable improvements were observed in key set.

請翻到下一張投影片。在呼吸系統方面，amlitelimab 在氣喘的 2 期研究中顯示出令人感興趣的療效，尤其是在難治性亞組中，但第 48 週年度氣喘急性發作率降低的主要終點在最高劑量下未達到統計學意義。關鍵數據集中觀察到了顯著改進。

The heterogenous inflammation subgroup of patients with high blood (inaudible), greater than 300 cells per microliter and elevated neutrophil at greater than 4,000 cells per microliter showed the greatest benefit treatment was well tolerated with no new safety concerns. We're still analyzing the study data, including biomarkers.

高血紅素（聽不清楚）超過每微升 300 個細胞且嗜中性球超過每微升 4,000 個細胞的異質性發炎亞組患者顯示最大的獲益，治療耐受性良好，沒有新的安全問題。我們仍在分析研究數據，包括生物標記。

Next steps will be subject to prioritizations within our overall respiratory fit. We are pleased by the recent efdoralprin alfa data, which showed superiority to the standard of care in the Phase 2 study to (inaudible) in deficiency emphysema. The recombinant protein has a longer half-life and can provide higher AAT serum levels with less frequent dosing of either once every three or four weekly.

下一步措施將根據我們整體呼吸系統健康狀況的優先順序而定。我們對最近 efdoralprin alfa 的數據感到高興，該數據表明，在 2 期研究中，efdoralprin alfa 在治療肺氣腫方面優於標準療法（聽不清楚）。重組蛋白的半衰期較長，只需每三週或四周給藥一次，即可提供更高的 AAT 血清濃度。

A Phase 2 over-label study is currently ongoing, which will add to the safety data. We will now engage in discussions with legoregulatory agencies to see if we can move ahead based on the data we have, supported by the upcoming safety studies.

目前正在進行一項二期超適應症研究，這將增加安全性數據。接下來，我們將與立法監管機構進行討論，看看能否根據我們掌握的數據，並在即將進行的安全研究的支持下，推進相關工作。

Please turn to the next slide. Lead-212 DOTAMTATE, our radioligand, showed intriguing overall response rates in patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors, otherwise known as [gapnats], a group are difficult-to-treat rare and [neurological] cancers.

請翻到下一張投影片。我們的放射性配體 Lead-212 DOTAMTATE 在生長抑素受體陽性的胃腸胰神經內分泌腫瘤（也稱為 [gapnats]）患者中顯示出令人感興趣的總體反應率，這是一組難以治療的罕見 [神經系統] 癌症。

And peptide receptor radionuclide therapy naive patients, the overall response rate was 57.1%. And in PRRT exposed patients, the overall response was 19.2%. Both measures were based on blinded independent central review. We observed a manageable safety profile that were similar across both counts.

對於未接受過勝肽受體放射性核素治療的患者，整體反應率為 57.1%。在接受 PRRT 治療的患者中，整體反應率為 19.2%。這兩項措施均基於盲法獨立中心審查。我們觀察到，兩種情況下安全性都比較好，且相似。

On immunology, my oral TNF (inaudible) didn't meet the predefined primary endpoint of 20 but showed clinically meaningful efficacy in a Phase 2 study in uncontrolled advanced treatment naive rheumatoid arthritis patients on background methotrexate across endpoints requiring a deeper disease control, including ACR50 and HDR70.

在免疫學方面，我的口服 TNF（聽不清）沒有達到預先設定的主要終點 20，但在一項針對未接受過甲氨蝶呤治療的晚期類風濕關節炎患者的 2 期研究中，在需要更深層疾病控制的終點（包括 ACR50 和 HDR70）方面顯示出具有臨床意義的療效。

The oral -- the oral treatment has the potential to be used as a combination backbone therapy with internal and external oral medicines, but the next step currently being outrated Finally, we are close to initiate 2 replicate Phase 3 studies for [duvaticug] and both Crohn's disease and ostic colitis. This treatment offers patient-friendly subcutaneous dosing with potential competitive safety and efficacy by selective targeting the DC3 receptor sold the positive Phase 2 data that read out last year and were presented an ECHO meeting this year.

口服治療有可能與內服和外用口服藥物合併作為骨幹療法，但下一步目前尚未確定。最後，我們即將啟動 2 項針對 [duvaticug] 治療克隆氏症和結腸炎的重複 3 期研究。該療法透過選擇性靶向 DC3 受體，提供對患者友善的皮下給藥方式，具有潛在的競爭性安全性和有效性。去年公佈的積極 2 期臨床數據在今年的 ECHO 會議上進行了展示。

Next slide, please. As a conclusion, let me share a status of our key mid- and late-stage development projects. Our immunology pipeline includes medicines with the available data, such (inaudible) Phase 3 program in AD with further potential life cycle management, Lunsekimig in Phase 2 and different asthma patient subgroup and potential LCM, such as COPD as well as Brivekimig in HS and others in mid-stage development, some of which I covered earlier, like elemental and data.

請看下一張投影片。最後，讓我向大家介紹一下我們重點的中後期開發專案的進度。我們的免疫學研發管線包括一些已有數據的藥物，例如（聽不清楚）針對 AD 的 3 期臨床試驗項目，具有進一步生命週期管理潛力；針對不同氣喘患者亞群和潛在生命週期管理的 Lunsekimig（如 COPD）；以及針對 HS 的 Brivekimig 和其他處於中期研發階段的藥物，其中一些我之前已經介紹過，例如我之前已經介紹過，例如我之前已經介紹過，例如我之前已經介紹過，例如其他元素和元素。

On itepekimab, I can share that a decision to move forward in COPD will be made subject to regulatory discussions and in collaboration with our valued partner, Regeneron, in rare diseases, Wayrilz has now approved for ITP in the US with potential for multiple new indications [venglustat] currently a Phase 3 for (inaudible) and lastly, efdoralprin alfa successful in Phase 2 for [alantitrypsin] deficiency with encouraging update just the other day.

關於itepekimab，我可以透露，是否推進其在COPD領域的應用將取決於監管方面的討論，並且我們將與我們重要的合作夥伴Regeneron合作，在罕見病領域，Wayrilz已在美國獲批用於治療ITP，並有可能獲得多種新的適應症；[venglustat]目前正在進行針對（聽不清楚）的3期臨床試驗alfa在治療[抗胰蛋白酶]缺乏症的2期臨床試驗中取得成功，並且就在前幾天發布了令人鼓舞的最新消息。

So CISA is well underway to this (inaudible) formulation already approved across different lines in combination regimens in multiple regions and (inaudible) in Getnet with data this week at. In neurology, tolebrutinib is in review for SPMS with a revised PDUFA date of December 28 and the Phase 3 for primary progressive multiple sclerosis with a readout before the end of the year.

因此，CISA 正在順利推進，該配方已在多個地區的不同產品線中獲準用於聯合治療方案，並且本週在 Getnet 也獲得了相關數據。在神經病學領域，托布替尼正在接受繼發性進展型多發性硬化症 (SPMS) 的審查，修訂後的 PDUFA 日期為 12 月 28 日；原發性進展型多發性硬化症的 3 期臨床試驗結果將於年底前公佈。

Frexalimab is in Phase 3 for relapsing remitting motesporasis in SPMS 2. And lastly, really probate in two Phase 3 studies for chronic inflammatory demyelinating polyneuropathy. Finally, in vaccines, we have multiple Phase 3 programs underway, such as Rave, V21 yellow fever vaccine and broad opportunities in flu.

Frexalimab 目前處於治療 SPMS 2 型復發緩解型多發性硬化症的 3 期臨床試驗階段。最後，兩項針對慢性發炎性脫髓鞘性多發性神經病變的 3 期研究正在進行中，結果令人信服。最後，在疫苗方面，我們有多個三期臨床試驗計畫正在進行中，例如 Rave、V21 黃熱病疫苗以及流感疫苗的廣泛應用前景。

Flu COVID combinations and pandemic flu right behind, as Paul covered earlier in his please. On my last slide, I plan to cover my usual news flow, news flows life for the remaining 3 months of the year and all of 2026. The last significant ITS25tare US decisions on polarbrutinib in SPMS and Phase 3 (inaudible) and multiple regulatory decisions. Next year, we expect the remaining Phase 3 readout amlitelimab in AD. In rare diseases, we also expect venglustat first relapse in two indications. In all cases, it's positive, regulatory submissions will follow later in the year.

正如保羅之前在他的文章中提到的，流感和新冠病毒的組合以及隨後的大流行性流感也緊隨其後。在最後一張投影片中，我計劃介紹我通常的新聞流，以及今年剩餘 3 個月和 2026 年全年的新聞流情況。ITS25tare 最近的重大決定是美國對 polarbrutinib 治療 SPMS 和 3 期臨床試驗的決定（聽不清楚）以及多項監管決定。明年，我們預計將公佈 amlitelimab 在 AD 治療中剩餘的 3 期臨床試驗結果。在罕見疾病領域，我們也預期將發表 venglustat 在兩種適應症的首次復發數據。總之，情況都是正面的，監管方面的申請將在今年稍後提交。

In addition, we anticipate multiple regulatory submissions based on data we've already received this year as long as regulatory decisions for medicines and backing under review. Before I close my sincere thank all colleagues in Sanofi R&D, who share my commitment to improve science in Sanofi and help advance our pipeline further. New initiatives in research all the way to regulatory approval. With this, I hand back to Paul.

此外，我們預計，根據我們今年已經收到的數據，只要藥品和擔保的監管決定正在審查中，就會有多個監管申請提交。在結束之前，我衷心感謝賽諾菲研發部門的所有同事，他們和我一樣致力於提升賽諾菲的科學水平，並幫助我們進一步推動產品研發。從研發到監理審批，所有新措施均已落實。說完，我把東西交還給保羅。

Okay. Thank you, Houman. We'll now open the call to questions. (Operator Instructions) The question be read by our panelists. Now, we will take the first question.

好的。謝謝你，侯曼。現在開始接受提問。（操作說明）問題將由我們的專家小組成員宣讀。現在，我們來回答第一個問題。

Please go ahead.

請繼續。

Sachin Jain, BofA.

Sachin Jain，美國銀行。

So first of all, I wonder if you could just update us on the (inaudible) debate and conference resolving any questions the FDA has had with that delayed PDUFA. And the second one, just to make sure there's no confusion in the market given the debate of 2Q, can we assume that your wording of profitable growth for '26 means EBIT and EPS ahead of sales?

首先，我想請您向我們介紹一下（聽不清楚）關於解決 FDA 對延遲的 PDUFA 的任何疑問的辯論和會議的最新進展。第二個問題，為了確保市場不會因為第二季的討論而產生混淆，我們能否假設您所說的 2026 年獲利成長是指 EBIT 和 EPS，而不是銷售？

Okay. Do you want to provide some clarity on the regulatory piece and the SPMS tolebrutinib.

好的。您是否想就監管方面以及 SPMS 托布替尼提供一些澄清？

Yes. Thanks for the question, pretty straightforward. As we reported earlier in the year, the FDA requested an extension. We've submitted data sets with the FDA, continued conversations and look forward to the. PDUFA December 28.

是的。謝謝你的提問，很簡單。正如我們今年早些時候報導的那樣，FDA 請求延期。我們已向FDA提交了數據集，並繼續進行對話，期待著結果。PDUFA 12月28日。

Thank you. Fracois?

謝謝。弗朗索瓦？

This unprofitable growth, I confirm that the idea is to have -- as we go down through the P&L, all items growing faster than at the upper end of the P&L, which means basically gross margin growing faster than sales growth, being faster in gross margin and EPS growing faster than -- we have achieved that each and every single quarter this year. We'll do it in 2025. We expect to get there in 2016, and we are working in the same -- to deliver the same objective for the following years as well.

我確認，這種無利可圖的成長，其理念是——隨著我們深入分析損益表，所有專案的成長速度都比損益表的高端專案更快，這意味著毛利率的成長速度基本上要超過銷售成長速度，毛利率和每股盈餘的成長速度都要更快——我們今年每個季度都實現了這一點。我們將在2025年完成。我們預計在 2016 年實現這一目標，並且我們正在朝著這個目標努力——以期在未來幾年也實現同樣的目標。

That's very clear. Next question.

這一點很清楚。下一個問題。

Luisa Hector, Berenberg.

路易莎·赫克托，貝倫貝格。

Perhaps I could ask the obligatory US policy question. Do you have any updates on your conversations with the US administration. Is there -- is it more complex for you with shared assets like DUPIXENT?

或許我可以問一個例行的美國政策問題。您與美國政府的對話有任何最新進展嗎？對於像 DUPIXENT 這樣的共享資產，您是否會遇到更複雜的情況？

And then should we be concerned about a degree of silence right now or is it simply that there is more of a bottleneck in terms of a long queue to speak with the administration, maybe Trump's busy agenda. Just any color on that sort of ability to communicate a (inaudible) there.

那麼，我們現在是否應該對這種程度的沉默感到擔憂呢？或者這只是因為與政府對話的人太多，排起了長隊，或者是因為川普的日程安排太忙，造成了瓶頸？任何顏色都可以，那種能力可以用來表達（聽不清楚）。

I think our answer is pretty straightforward, which is we've had ongoing dialogue with the US government and indeed multiple governments since before we received the letter. Back at the end of July, I think it was, we focus on making sure that people understand the value we can bring. And those conversations have continued throughout this whole process. So probably coming on bottlenecks or other implications, but I think that's probably as much as we can say at this point.

我認為我們的回答非常直接，那就是，自從我們收到這封信之前，我們就一直在與美國政府以及多個國家的政府對話。我記得是在七月底，我們當時的重點是確保人們了解我們所能帶來的價值。在整個過程中，這些對話一直持續著。所以可能會出現瓶頸或其他影響，但我想目前我們只能說這麼多了。

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

好的。謝謝你，路易莎。下一個問題。

Shirley Chen, Barclays.

雪莉·陳，巴克萊銀行。

So I have a question on (inaudible). So as you guys said, the Q3 orders have been impacted by inventory carryover from last season. Could you please give us a sense of how Q4 ordering trends are tracking so far? And are we still expecting a 3Q, 4Q equal debt?

我有一個關於…的問題（聽不清楚）正如你們所說，第三季的訂單受到了上一季庫存積壓的影響。能否請您介紹一下目前第四季的訂單趨勢？我們是否仍預期第三季和第四季的債務將持平？

And also given the competition that is ongoing, like how do we see the (inaudible) competition is going to impact the 4Q number, given we know that Merck actually entered the market a late-ish in 3Q. And also, we saw very strong growth in ex-US market. And what do you see the opportunity there -- and also what is your overall perspective for (inaudible) in 2026?

此外，考慮到目前正在進行的競爭，例如，鑑於我們知道默克實際上是在第三季後期才進入市場的，那麼我們該如何看待（聽不清楚）競爭將如何影響第四季度的業績呢？此外，我們也看到美國以外市場實現了非常強勁的成長。那麼，您認為那裡有哪些機會呢？您對 2026 年（聽不清楚）的整體看法是什麼？

Okay. So the full questions, Tom are for you.

好的。所以，湯姆，所有的問題都問你了。

Rich question. Thank you very much, Julie. Maybe a couple of points to address these different elements. Thanks for giving an eye to the best performance in -- as you listed a few points of highlights. First of all, overall for before, so that we increased our performance versus last year.

這個問題很有意思。非常感謝你，朱莉。或許可以提出幾點來闡述這些不同的要素。感謝您關注最佳表現——正如您列舉的一些亮點一樣。首先，整體而言，我們比去年提高了業績。

And we have done that notably by extending the penetration to about 40 countries. Now in your question, there were some geographic elements to it. On the US part, yes, absolutely, you're correct on what's going on in the US. And yes, we do confirm the guidance that we had provided last quarter at Q4, we expect it to be roughly in the same order of May, June for (inaudible) overall for global performance.

我們尤其透過將市場滲透範圍擴大到約 40 個國家/地區而實現了這一目標。你的問題包含了一些地理因素。就美國而言，是的，完全正確，你對美國正在發生的事情的判斷是正確的。是的，我們確認了上個季度（第四季）給予的指引，我們預期第四季整體全球業績將與五月、六月大致相同（聽不清楚）。

The second point, I think you wanted to mention a couple of points on the environment and the competition. Without talking about the competition, specifically because we don't do that. Maybe I can say a few words on the fact that actually, if you look at last year 2024, first year of full supply and (inaudible) was a blockbuster. You remember that if you look at the US performance, the total, I would say, coverage rate of all babies in the US was around 55% for Polaris solutions available. Roughly 55% of babies were getting some form of R&D protection.

第二點，我想您是想談談環境和競爭方面的一些問題。我們不談競爭，因為我們不做這種事。也許我可以簡單說幾句，事實上，如果你看看去年 2024 年，也就是全面供應的第一年，那一年（聽不清楚）取得了巨大的成功。您可能還記得，如果您看一下美國的表現，我認為，Polaris 解決方案在美國所有嬰兒中的總覆蓋率約為 55%。大約 55% 的嬰兒獲得了某種形式的研發保護。

We're really focused in 2025, and I think we will be focused in 2026 to increasing that vaccination coverage rate we expect 2025 to land around 70% vaccination covered rate in the US, and that therefore, we welcoming efforts from everywhere to make sure that we increase the importance of (inaudible) what we are seeing in the signals in the US is that by far, forte is the favorite product, the favorite [acception] from US prescribers.

我們非常關注 2025 年，我認為 2026 年我們也會專注於提高疫苗接種覆蓋率。我們預計 2025 年美國的疫苗接種覆蓋率將達到 70% 左右。因此，我們歡迎各方努力，確保我們提高（聽不清楚）的重要性。我們從美國的訊號中看到，到目前為止，Forte 是最受歡迎的產品，是美國處方醫生最喜歡的[接受度]。

Simply due to the fact that it's highly differentiated with an extended life of 71 day it makes it by far the longest acting monocular antibodies for the prevention of RSV. And it has an incredible real-world evidence behind it. So that's very important moving forward.

僅憑其高度差異化的特性，以及長達 71 天的持續時間，就足以使其成為迄今為止預防 RSV 作用時間最長的單株抗體。而且它背後有大量真實世界的證據支持。所以這對未來的發展至關重要。

Okay. Thank you. Next question, please.

好的。謝謝。下一個問題。

Matthew Weston, UBS.

瑞銀集團的馬修‧韋斯頓。

Thank you. Two questions, please. François, I'm going to buck the trend. Most people ask 2026 guidance questions. I'm going to ask a 2027 guidance question. Slide 29 flags the Regeneron R&D reimbursement stepping down.

謝謝。請問兩個問題。弗朗索瓦，我要反其道而行。大多數人都會問到關於2026年的升學指導問題。我要問一個關於2027年指導性問題。第 29 張投影片指出 Regeneron 研發報銷正在逐步減少。

It's something that's been familiar, I think, for many people for a while, but maybe not fully reflected in consensus.

我認為，對許多人來說，這種情況已經熟悉一段時間了，但可能還沒有充分的共識。

The step down is actually much greater in 2017 than in 2016. And your slide implies about EUR0.5 billion EBIT gap in '27. I'm just trying to understand, are there any additional levers within manufacturing gross margin or the business that could help mitigate that or that's something that we've just got to get prepared for even though it's 1.5 years away.

2017 年的降幅實際上比 2016 年大得多。你的幻燈片顯示，2027 年的息稅前利潤缺口約 5 億歐元。我只是想了解一下，在製造業毛利率或業務方面，是否還有其他槓桿可以幫助緩解這種情況，或者即使還有 1.5 年的時間，我們也必須為此做好準備。

And then one for Human, you set out your enthusiasm for amlitelimab. Lilly has just reported the findings from the Phase 3 join extension study for (inaudible), which looked to Q8-week dosing and showed very limited erosion in efficacy. I'd be very interested if you think that limits the differentiation for amlitelimab where you were aiming for your 12 week to be differentiated. Thank you.

然後，在人類方面，你表達了對 amlitelimab 的熱情。禮來公司剛剛公佈了（聽不清楚）的 3 期聯合擴展研究結果，該研究著眼於每 8 週給藥一次的方案，結果顯示療效下降非常有限。如果您認為這會限制 amlitelimab 的差異化，而您原本希望在 12 週時實現差異化，那麼我將非常感興趣。謝謝。

Okay, thank you. François, do you want to catch that? And then maybe Brian and Houman, depending --

好的，謝謝。弗朗索瓦，你想接住那個嗎？然後或許還有布萊恩和侯曼，要看情況。--

Yes. Matthew, I think that this is a good question for 2027, indeed, and which is what I presented in the last call at the end of July, the fact that in 2026, we will have -- we will lose about EUR300 million of R&D reimbursement from Regeneron. And as I said a few minutes ago, it will be entirely offset by the additional royalties that we will receive from AMVUTTRA .

是的。馬修，我認為這確實是 2027 年的一個好問題，也是我在 7 月底的最後一次電話會議上提出的問題，即 2026 年，我們將失去 Regeneron 公司約 3 億歐元的研發報銷。正如我幾分鐘前所說，這筆費用將完全被我們從AMVUTTRA收到的額外版稅所抵銷。。

In 2027, indeed, we will have a much more significant amount of R&D reimbursement in terms of decrease because we will lose EUR800 million from 1 year to the other and this will not be fully offset in 2027 by the additional AMVUTTRA royalties, which will be around EUR300 million, which is in one of my appendices in this presentation as well.

2027 年，我們的研發報銷金額確實會大幅下降，因為我們將比前一年損失 8 億歐元，而 2027 年 AMVUTTRA 的額外特許權使用費（約 3 億歐元）也無法完全彌補這一損失，這部分特許權使用費也列在我本次演講的附錄之一中。

So we'll have a gap in deed of about EUR0.5 billion. Will we be able to cover it with other exceptional items or, let's say, nonrecurring item? The answer is no. That being said, I mean, we will continue growing at a reasonable pace as well. So -- and I said it last time that -- if there was 1 year where we were not sure about increasing our profitability and deliver this profitable growth.

因此，我們將面臨約 5 億歐元的資金缺口。我們能否用其他特殊項目或非經常性項目來彌補這部分支出？答案是否定的。也就是說，我們也會繼續以合理的速度發展。所以——我上次也說過——如果有一年我們不確定能否提高獲利能力並實現獲利成長。

It would be 2027 for that same reason. That being said, and I repeat what I said last quarter, which is we expect our BOI to increase in absolute value in 2017 in spite of this impact.

出於同樣的原因，應該是2027年。也就是說，我重申上個季度我所說的，儘管受到這種影響，我們預計 2017 年我們的 BOI 絕對值仍將成長。

So we will be able, in absolute value to cover the gap, the EUR500 million gap. And most probably, I believe that we may be in a position, still early to say to even increase our profitability in terms of BY in 2017 as well. I say we may be still very early. We have not even completed our 2026 budget. So I want to be careful.

因此，我們絕對有能力彌補這5億歐元的缺口。而且，我認為我們很有可能在 2017 年實現盈利能力的提升，雖然現在說這還為時過早。我認為我們現在可能還處於非常早期的階段。我們甚至還沒完成2026年的預算。所以我想謹慎一點。

But directionally, there is probably a possibility largely as a consequence the growth leverage that we will get from superior growth.

但從方向上看，這很可能主要是由於我們將從超額成長中獲得的成長槓桿效應。

Okay. Thank you. So maybe Brian, first and then Houman.

好的。謝謝。所以或許先是布萊恩，然後是侯曼。

Yes. I think -- great question. Thank you very much. I think as you look at the marketplace, we've always said this is a marketplace that's going to continue to grow. The bio penetration rate is extremely low, just over 14%, so more assets coming into the marketplace will only help the marketplace grow.

是的。我覺得──問得好。非常感謝。我認為，縱觀整個市場，我們一直都認為這是一個會持續成長的市場。生物技術滲透率極低，僅略高於 14%，因此更多資產進入市場只會促進市場成長。

As you can see from our growth today in DUPIXENT a market -- a product that's already in the marketplace, it's benefiting from other therapies coming to the marketplace. That said, one thing that we've said consistently for a very long time, these IL-13s are incomplete therapies, and we've seen them on the market now. Actually, if you look at [lebri], that's been on the market for nearly a year now as single-digit share.

從我們目前在 DUPIXENT 市場的成長可以看出，該產品已經進入市場，並且受益於其他療法進入市場。也就是說，我們一直以來都強調，這些 IL-13 療法是不完全有效的療法，而我們現在已經在市場上看到了它們。實際上，如果你看看 [lebri]，它上市已經近一年了，市佔率一直只有個位數。

So we're seeing while it's helping grow the marketplace. It's really not taking very much share from DUPIXENT. DUPIXENT, we believe still has a very strong profile. And each of these still have these dosing ranges that are either two weeks or at the best, four weeks is what we're seeing right now. So we think that there's a lot of room for a much more durable dose in the marketplace, assuming we finish the regulatory trials and get it to the marketplace for -- excuse me. No?

所以我們看到，它同時也在幫助市場發展。它實際上並沒有從DUPIXENT手中奪走太多市場份額。我們認為，DUPIXENT 仍然具有非常強勁的市場競爭力。而這些藥物的用藥週期仍然為兩週，或最多四周，這是我們目前看到的。所以我們認為，市場上對更持久的劑量有很大的空間，假設我們完成監管試驗並將其推向市場——抱歉。不？

Just, Matthew, to the question as well as the Bioplan comment, which is important. This is a totally novel mechanism an apical node in the immune response with not only durability, but multiple differentiating factors. We remain based on the data, actually, the K1 study, encouraged by the potential for amli.

馬修，我只想回答這個問題，以及 Bioplan 的評論，這很重要。這是一種全新的機制，是免疫反應中的頂端節點，不僅具有持久性，而且具有多種分化因素。我們仍然以數據為依據，實際上是以 K1 研究為依據，並受到 amli 潛力的鼓舞。

Great. Thank you. Next question.

偉大的。謝謝。下一個問題。

Seamus Fernandez, Guggenheim.

西莫斯·費爾南德斯，古根漢美術館。

So just a couple of quick questions. Can you just update us on relaprugard and just kind of timing dynamics around that? It's unclear if that's still on track for second half 2026 readout in CIDP. So I just wanted to clarify that. And then more broadly, -- just hoping to get a better understanding of when we're going to learn more about the programs that have had kind of unfortunate outcomes and where a number of programs are under review, including the oral TNF, including itepekimab.

那麼，就問幾個簡單的問題吧。能否給我們更新一下 relaprugard 的情況以及相關的時事動態？目前尚不清楚CIDP在2026年下半年的進展是否仍按計畫進行。所以我想澄清一下。更廣泛地說，——只是希望更好地了解我們何時才能更多地了解那些結果不太好的項目，以及哪些項目正在接受審查，包括口服 TNF，包括伊替佩基單抗。

It just seems like there's a lot of secondary analysis exploration going on and holding on to assets as part of the pipeline. And I'm just trying to get a better understanding of when we're going to know the advancement or elimination of some of those assets that haven't quite lived up to at least investor expectations.

看起來有很多二次分析探索正在進行，並將資產保留在專案儲備中。我只是想更了解，我們何時才能知道那些尚未達到投資者預期的一些資產的進展或淘汰情況。

Seamus, I'll try and be succinct on this one. On (inaudible), we've updated the timelines at this Q3. And the reality is that the outcome for the 2 Phase 3 studies for CIDP are just breaking over the year. This is purely a patient recruitment phenomenon, and we look forward to seeing the results of these studies. You'll remember the Phase 2 studies were extremely encouraging.

西莫斯，我盡量長話短說。關於（聽不清楚），我們已在本季第三季更新了時間表。而現實情況是，CIDP 的兩項 3 期研究的結果將在今年陸續公佈。這純粹是一個病患招募現象，我們期待看到這些研究的結果。您應該還記得，二期臨床試驗的結果非常令人鼓舞。

And then on your second point about when you'll see the data and when we make decisions, obviously, those datasets will be presented at the relevant scientific congresses, I've already announced today that we will go forward subject to regulatory approval with our partners in itepekimab. So there's no tardiness there. Obviously, we have to take a retention then before we move forward. into replication Phase 3.

至於你提到的第二點，即何時能看到數據以及何時做出決定，顯然，這些數據集將在相關的科學會議上公佈。我今天已經宣布，我們將與itepekimab的合作夥伴一起，在獲得監管部門批准後繼續推進。所以不存在遲到的情況。顯然，在進入複製階段 3 之前，我們必須進行保留測試。

And then for the other studies, I've already alluded to the fact that we will take a portfolio view on asthma with a number of our assets and figure out what we take forward in asthma and on balance 10, we just have access to the results I've outlined the importance of ACR 15 and 70 and the fact they're clinically meaningful. And we'll figure out -- as we've always said, we've been consistent in our view that we'll figure out exactly the role of Ballina in mono and combination therapies, both with our own molecules and partners.

至於其他研究，我已經暗示過，我們將從投資組合的角度看待氣喘，並考慮我們的一些資產，以及我們在氣喘和 Balance 10 方面應該採取什麼措施。我們已經概述了 ACR 15 和 70 的重要性，以及它們具有臨床意義的事實。我們會弄清楚——正如我們一直所說，我們始終堅持認為，我們會弄清楚 Ballina 在單藥療法和聯合療法中的確切作用，無論是與我們自己的分子還是與合作夥伴的分子。

Thank you, Houman. Thank you, Seamus. Great questions. We've finally we've seen it with many of our competitors having hits and misses in immunology over the last months that these extra levels of thinking actually are worth doing and standing good step because you really do pick the right patient population. So taking time, I think, is wise for us.

謝謝你，侯曼。謝謝你，西莫斯。問得好。我們終於看到，在過去的幾個月裡，許多競爭對手在免疫學領域經歷了成敗起伏，這表明這些額外的思考層次實際上是值得的，而且是邁出了正確的一步，因為你確實可以選對患者群體。所以我覺得，花時間對我們來說是明智的。

Next question.

下一個問題。

Simon Baker, Redburn.

西蒙貝克，雷德本。

Two, please. Firstly, on DUPIXENT Fossil, you said that the gross margin benefit from manufacturing improvements is now fully being captured. I'm just wondering if you could give us some idea of the magnitude of the gross margin improvement this quarter, which is down to DUPIXENT manufacturing?

請給我兩個。首先，關於DUPIXENT Fossil，您曾說過，製造流程改進帶來的毛利率收益現在已經完全實現了。我想請您大致介紹一下本季毛利率提升的幅度，這主要歸功於DUPIXENT的生產？

And then a question on indication opportunities. Houman, you mentioned rilzabrutinib in Graves disease. That's potentially not a particularly rare condition. So I just want to get your thoughts on the potential you see there? And also the other 1 in light of Moderna's failure this week is CMV vaccination. I know you've been in this space in the 90s. I just wonder what your level of appetite was for it now.

然後是一個關於適應症機會的問題。Houman，你提到了利札布替尼在格雷夫茲病的應用。這可能並非一種特別罕見的疾病。所以我想聽聽您對那裡的潛力有什麼看法？此外，鑑於 Moderna 本週的失敗，CMV 疫苗也是值得關注的疫苗。我知道你90年代就涉足這個領域了。我只是好奇你現在對它還有什麼興趣。

All right. Thank you, Simon. François?

好的。謝謝你，西蒙。弗朗索瓦？

Yes, Simon, on DUPIXENT, the gross margin contribution from the C3 manufacturing was actually very limited in Q3 itself. I mean this is -- we just took the opportunity to mention that -- we have completed the full implementation of this new technique, which has spread over a couple of years, actually. But it did not have a significant impact in Q3 per se.

是的，Simon，關於DUPIXENT，C3生產在第三季的毛利率貢獻實際上非常有限。我的意思是——我們只是藉此機會提一下——我們已經完成了這項新技術的全面實施，實際上這項技術已經推廣了好幾年。但這本身並沒有對第三季產生重大影響。

I take the opportunity to mention that -- our gross margin increased globally for the company by 2.5 percentage points in Q3 and by 1.8 percentage points -- most of the factors are still contributing to it are still relevant for the future to a certain extent. One of them is volume growth. Our volume grew by 12% since the beginning of the year.

我藉此機會提一下——我們公司第三季度的全球毛利率增長了 2.5 個百分點，第三季度增長了 1.8 個百分點——大多數促成這一增長的因素在一定程度上仍然具有現實意義。其中之一是銷量成長。今年以來，我們的銷量成長了12%。

We expect to continue at a high level. we are obviously benefiting from a positive product mix, including this quarter, vacillate is much more significant than the new manufacturing technique for DUPIXENT. We are also obviously benefiting from the industrial restructuring that we did over the last couple of years, plus there were some one-offs this quarter last year and this year which did create a little bit of positive impact as well.

我們預計將繼續保持高水準。顯然，我們受惠於正面的產品組合，包括本季在內，波動性的影響遠比DUPIXENT的新生產技術更為顯著。顯然，我們也受益於過去幾年進行的產業結構調整，此外，去年和今年本季的一些一次性事件也產生了一些正面影響。

If we look at it underlying because we were at the high range, once again, with 2.5 percentage points of increase in Q3 if we exclude the one-offs and some of the items that will not necessarily replicate each and every single quarter like (inaudible) for example, you can consider that the underlying gross margin increase that we have experienced since the beginning of the year, is around 1 percentage point. This is obviously before any impact if you want to use that for the future. That does not include any potential impact coming from tariffs.

如果我們從根本上看，因為我們再次處於高位，第三季度增長了 2.5 個百分點。如果我們排除一次性因素和一些不一定會在每個季度重複出現的項目，例如（聽不清楚）等，那麼你可以認為，自年初以來我們所經歷的根本毛利率增長約為 1 個百分點。顯然，這是在產生任何影響之前的情況，如果你想將其用於未來的話。這還不包括關稅可能帶來的任何影響。

Francçois, okay. Houman, Graves; and then Thomas, CMB.

弗朗索瓦，好的。Houman，Graves；然後是 Thomas，CMB。

Sorry, thanks for that insightful question. As you'll know, Graves is a well-established autoantibody-related disorder, the classic long-acting thyroid stimulating antibodies, TSR antibodies are important. So number one, it's a economical autoimmune disorder. Number two, we know from investor-initiated studies that B-cell suppression is a successful therapy, particularly for the ophthalmopathy.

抱歉，謝謝你提出這麼有見地的問題。如你所知，格雷夫茲病是一種已確立的自身抗體相關疾病，經典的長效甲狀腺刺激抗體（TSR抗體）非常重要。首先，這是一種經濟上的自體免疫疾病。第二，我們從投資者發起的研究中得知，B 細胞抑制是一種成功的療法，特別是對於眼部疾病而言。

And thirdly, with our unique covalent reversible molecule and rilzabrutinib for those already shown significant promise in multiple disorders, including we IgG4 disease and ITP. I think that Graves is a promising opportunity. We look forward to taking the molecule forward.

第三，我們獨特的共價可逆分子和 rilzabrutinib 已在多種疾病中顯示出顯著的療效，包括 IgG4 疾病和 ITP。我認為格雷夫斯是一個很有前途的機會。我們期待著進一步推進該分子的研究。

You are completely correct that it's not a rare disorder of that source so it's not super rare and therefore, I think it's a potential opportunity, particularly the ophthalmic.

您說的完全正確，這種疾病並非罕見，因此它並不十分罕見，所以我認為這是一個潛在的機會，尤其是在眼科領域。

Short, not much to say. The news is been recent, as you know, very well, Simon. So I would not comment, I need to see the full data set -- the only thing I can refer to is indeed that quite a while ago, a few decades ago, we had worked on this antigen.

簡短，沒什麼好說的。如你所知，西蒙，這則新聞是最近才傳開的。所以我不予置評，我需要查看完整的數據集——我唯一能提及的是，的確在很久以前，幾十年前，我們研究過這種抗原。

It's a difficult target while we had reached some, I would say, interim efficacy our assumption at that time was that it will not be sufficient to reach a protection level, and that's why we have adopted this program quite a while ago. Sadly, overall, because the field of CMV vaccination is importantly, and we would welcome a vaccine against this devastating disease.

這是一個難以實現的目標。雖然我們已經取得了一些，我認為的，臨時的成效，但我們當時的假設是，這不足以達到保護水平，這就是為什麼我們很久以前就採取了這項計劃。令人遺憾的是，總體而言，因為 CMV 疫苗領域非常重要，我們非常歡迎針對這種毀滅性疾病的疫苗。

Okay. Thank you. Next question, please.

好的。謝謝。下一個問題。

Richard Vosser, JPMorgan.

理查沃瑟，摩根大通。

Question on DUPIXENT and just giving us a little bit more on the development around COPD and the -- also the gross to net how that developed in the quarter now we should think about that in 2016, but also how the COPD launch is going? It seems to be developing a little bit better this quarter?

關於DUPIXENT的問題，能否再詳細介紹一下COPD的進展狀況，以及本季毛利到淨利的轉換情況？我們現在應該考慮一下2016年的情況，還有COPD的上市進展如何？本季情況似乎略有改善？

And then second question, just on the Inhibrx data, just your to file, I think you need some of the more long-term safety data that you called out from the open-label extension. Just wondering what, if anything, is being looked at in terms of that safety data from the regulators? Is there anything of interest that they want to see or rule out. Thanks very much.

第二個問題，就 Inhibrx 資料而言，我認為您需要一些您提到的來自開放標籤擴展研究的更長期的安全性資料。我想知道監管機構在安全資料方面究竟在關注哪些方面？他們有什麼特別想看或想排除的東西嗎？非常感謝。

Okay. Brian.

好的。布萊恩。

Yes, Richard. And first and foremost, I think the really strong overall growth that you've seen is really coming from all different sources of growth. If you think about it. First, our foundational indications. We continue to grow biopenetration in things like asthma, atopic dermatitis, EoE, nasal polyps.

是的，理查德。首先，我認為你們看到的強勁整體成長其實是來自各種不同的成長來源。仔細想想。首先，我們的基本指標。我們持續提高生物滲透性，用於治療氣喘、異位性皮膚炎、嗜酸性粒細胞性食道炎、鼻息肉等疾病。

But also, we've moved into -- about a year ago, we launched in COPD, and we've really seen a strong success actually in COPD, 1 of our fastest actually, it's our fastest respiratory indication as far as growth rate goes. So that plus CSU plus BP, you can see now 8 indications deep into the US Our sources of growth are coming from everywhere, and of course, launching around the world. It also has actually created this really strong momentum.

此外，大約一年前，我們進軍了 COPD 領域，並且確實在 COPD 領域取得了巨大的成功，COPD 實際上是我們增長速度最快的呼吸系統適應症之一。所以，加上 CSU 和 BP，現在可以看到 8 個跡象表明美國市場已經進入了深遠領域。我們的成長來源來自四面八方，當然，我們也在世界各地推出產品。它實際上也創造了非常強勁的發展勢頭。

We've seen a 26% growth this quarter and reaching over $4 billion in sales. As it relates to gross to net, obviously, that's captured in there in reference to our sales growth. This is something that we've monitored for a long time. Actually, we see that as we go into additional sources, if you will, there are different payer groups.

本季我們實現了 26% 的成長，銷售額超過 40 億美元。至於毛利潤與淨利潤的關係，顯然，這已經反映在我們的銷售成長中了。這是我們長期以來一直在關注的事情。實際上，當我們進一步了解其他來源時，會發現不同的付款方群體。

We obviously will provide discounts to get into different access for different patient populations. But again, this is something we've known for a long time, and it's captured in our long-term guidance for DUPIXENT.

我們顯然會為不同的患者群體提供不同的折扣，讓他們能夠獲得不同的醫療服務。但話說回來，這是我們早就知道的事情，並且已經體現在我們對 DUPIXENT 的長期指導方針中。

Okay. Houman in (inaudible)

好的。侯曼（聽不清楚）

Excited to have done this acquisition, an example of our disciplined capital allocation policy -- and it's exciting that the preliminary data has improved. So promising comparing both the Q3 and Q4 to some of the standards of care. You're correct that we're interested in the long-term extension study, which is open-label for the safety data, there is no specific. If you remember, this is a fusion protein like an antibody, there's no specific side effects we are looking for, but you'll have noticed in the press release that the safety and tolerability were in line with that, which was expected.

很高興完成了這項收購，這是我們嚴謹的資本配置政策的一個例證——而且初步數據有所改善，這令人振奮。與一些護理標準相比，Q3 和 Q4 的結果都非常令人鼓舞。您說得對，我們對長期擴展研究感興趣，這是一項開放標籤的安全資料研究，沒有具體規定。如果你還記得的話，這是一種類似抗體的融合蛋白，我們沒有特別關注的副作用，但你會在新聞稿中註意到，其安全性和耐受性與預期相符。

Okay, thank you. Next question, please.

好的，謝謝。下一個問題。

Michael Leuchten, Jefferies.

Michael Leuchten，傑富瑞集團。

Two questions for François, please. One, I just wondered if I could prod you a little bit more on the seasonality comment on gross margin. You said the DUPIXENT processes now tucked in and you returned to normal patterns. Just wonder what you meant by that. And then if most of the driver of the gross margin increase in Q3, still a whole. Just wondering why you opted not to offer an increase to guidance for this year.

請問弗朗索瓦兩個問題。第一，我只是想再追問關於毛利率季節性變動的問題。你說 DUPIXENT 的治療過程現在已經結束了，你的治療模式也恢復正常了。我只是想知道你這話是什麼意思。如果第三季毛利率成長的大部分驅動因素仍然是整體。我想知道為什麼您選擇不提高今年的業績指引。

Okay. Thank you. François.

好的。謝謝。弗朗索瓦。

So as I said, the 2.5 percentage points of increase that we had in our gross margin is probably not necessarily a good proxy for 2026. So I do believe that we have some factors that will stay there like our volume growth, like, for example, even the product mix -- these issues are structural, but we won't get another increase next year of 2.5 percentage points in gross margin. So it will be probably closer maybe to what I said, underlying maybe 1 percentage points, benefiting from volume and product mix.

正如我所說，我們毛利率成長了 2.5 個百分點，但這未必能很好地代表 2026 年的情況。所以我相信有些因素會一直存在，例如銷售成長，例如產品組合——這些都是結構性問題，但明年我們的毛利率不會再增加 2.5 個百分點。所以，實際結果可能更接近我之前所說的，可能會有 1 個百分點的提升，受益於銷售量和產品組合的變化。

The other thing in terms of guidance, I'm glad you asked the question. So we do confirm our full-year guidance, which is high single-digit growth -- sales growth today, after 9 months, we are at 8.8% year to date. So do expect some increase from where we are in -- at the end of September business EPS growth is low double digit, even excluding the benefit of share buyback.

至於指導方面，我很高興你提出了這個問題。因此，我們確認全年業績預期，即實現高個位數成長－截至目前，9 個月後的銷售成長率為 8.8%。因此，預計會比我們目前的水平有所提高——截至 9 月底，即使不考慮股票回購帶來的好處，企業每股收益成長率也將達到兩位數的低水平。

We are excluding share buyback at 9.9%. So do expect there as well for the full year that we will go up from where we are as at the end of September. So just to clarify as well, our full year guidance assumes basically that Q4 will be the best quarter in sales, OI and EPS growth this year.

我們不計入9.9%的股票回購費用。所以預計今年全年我們的業績都會比九月底的水準上升。為了進一步澄清，我們的全年業績預期基本上假設第四季度將是今年銷售額、營業利潤和每股收益成長最好的一個季度。

We will do better than we have done in any other quarter. Q3 was anyway a bit softer because of the comps, as we said earlier. There is just one thing, I want to take the opportunity to mention one thing, maybe what the Street does not always estimate is a profit sharing with Regeneron.

我們將比其他任何一個季度都做得更好。正如我們之前所說，由於同期比較因素，第三季整體表現略顯疲軟。我想藉此機會提一件事，也許華爾街並不總是預料到的是與 Regeneron 的利潤分成。

That includes, by the way, both DUPIXENT and Kevzara because there is probably an understanding that it rose in line with sales of DUPIXENT. It doesn't. Let me just give you some further color. For example, if we look at DUPIXENT sales in H1, they grew by 21%, and the Regeneron profit sharing grew by 32%, so 11 percentage points faster -- if I do the same analysis for Q3, DUPIXENT sales grew by 26%, which is remarkable.

順便一提，這其中也包括 DUPIXENT 和 Kevzara，因為人們可能認為它的價格上漲與 DUPIXENT 的銷售額同步。並非如此。我再補充一些細節。例如，如果我們看一下 DUPIXENT 上半年的銷售額，它增長了 21%，而 Regeneron 的利潤分成增長了 32%，比上半年快了 11 個百分點——如果我對第三季度進行同樣的分析，DUPIXENT 的銷售額增長了 26%，這非常了不起。

And Regeneron profit -- the profit sharing with Regeneron grew by 37%. So another 11 points higher than sales. So once again, it is a profit sharing. It's not linked necessarily fully to sales, and there is about 10 to 11 points of growth in terms of difference between the 2 concepts.

而 Regeneron 的利潤——與 Regeneron 的利潤分成成長了 37%。比銷售額高出11個百分點。所以，這又是一種利潤分成模式。它與銷售額不一定完全相關，而且這兩個概念之間的差異大約有 10 到 11 個百分點的增長。

Next question, please.

下一個問題。

Florent Cespedes, Bernstein.

弗洛朗·塞斯佩德斯，伯恩斯坦。

Florent Cespedes from Berstein, two quick questions, please. First, on M&A, with the massive (inaudible) of DUPIXENT and with the mixed use flow on the pipeline, maybe be more aggressive in terms of product acquisitions and maybe kind of a Blueprint-like transactions is something that we should see in the future?

來自伯恩斯坦的弗洛倫特·塞斯佩德斯，請問兩個問題。首先，在併購方面，鑑於 DUPIXENT 的巨大成功（聽不清楚）以及正在研發中的混合用途藥物，或許應該在產品收購方面更加積極主動，未來我們或許應該看到類似 Blueprint 的交易？

And maybe a second quick question for Thomas on vaccines. Can you share with us how do you see the trend that have been flow with the vaccines fatigue that we observed across the world, so some color on this would be great. Thank you.

或許我還可以再快速問湯瑪斯一個關於疫苗的問題。您能否和我們分享您如何看待世界各地出現的疫苗疲勞趨勢？如果能就此提供一些見解就太好了。謝謝。

Maybe I didn't quite catch perfectly the first question, but it was regarding M&A and should we be doing more and more blueprint, I guess, what I think heard. François, do you want to comment?

也許我沒完全聽清楚第一個問題，但它是關於併購的，以及我們是否應該制定越來越多的藍圖，我猜，我聽到的是這樣。弗朗索瓦，你想發表一下意見嗎？

Just a few words, maybe Paul, you can complete it? But it's not really about being aggressive. It's about finding the relevant acquisitions. We have space in our balance sheet. We said that we want to retain our AA rating.

保羅，或許你能幫我補充幾句話？但這其實與咄咄逼人無關。關鍵在於找到合適的收購目標。我們的資產負債表上還有空間。我們說過，我們希望維持AA評級。

In order to get there, we could afford -- once again, this is not necessarily what we want to do, but we could afford investing in BD and M&A currently something like EUR14 million, EUR15 billion and still retain our AA rating.

為了實現這一目標，我們有能力——再次強調，這不一定是我們想做的，但我們有能力在業務拓展和併購方面投資大約 1400 萬歐元到 150 億歐元，並且仍然保持我們的 AA 評級。

And what we are looking for is to meet three criteria, basically strategic fit, which is around our four therapeutic areas and possibly white spaces as well. Second, scientific differentiation and relevance and the first-in-class, best-in-class. And third, the financial return as well without any certainty -- so it's less a matter of amount of aggressiveness. It's more about finding the right targets at the right time at the right path.

我們正在尋找符合三個標準的產品，基本上是策略契合度，主要圍繞著我們的四個治療領域，也可能包括一些空白領域。其次，要具備科學差異化和相關性，做到同類最佳。第三，財務報酬也沒有任何確定性──所以這與其說是激進程度的問題，不如說是風險承受能力的問題。關鍵在於在正確的時間、透過正確的途徑找到正確的目標。

Yeah, yeah, I think that's great. We've been really disciplined. François, when he came in, actually went back and looked at all of our acquisitions and agreements to decide whether we allocated capital to his standard. And that was somewhat relieved to find out that is there. There is a huge amount of discipline.

是啊，是啊，我覺得太好了。我們一直都很自律。弗朗索瓦上任後，實際上回顧了我們所有的收購和協議，以決定我們是否按照他的標準分配了資本。得知確實有這樣的地方，我多少鬆了一口氣。這裡紀律非常嚴格。

There is a huge amount of discipline. And I think you've just heard how advocates done in Q3. So we're really -- we're very good at it, but we have to be a little bit choosy about what we do. I think that's very reasonable.

這裡紀律非常嚴格。我想你們剛才已經聽到了倡議者在第三季的表現。所以我們真的很擅長做這件事，但我們必須對我們所做的事情有所選擇。我認為這非常合理。

Okay, Tom, vaccines.

好的，湯姆，疫苗。

Thanks for the question on flu. A couple of points. First of all, it's earlier. We're still in October. But indeed, as you had in mind with your question, I think it's fair with the first few weeks that we observed a little bit back nation rate on the sub side when it comes to flu vaccination, particularly in the US, so we see a softer this year to date.

感謝您提出關於流感的問題。幾點說明。首先，時間更早。現在還是十月。但正如您在問題中所想的那樣，我認為在流感疫苗接種率方面，尤其是在美國，前幾週出現全國平均水平略有下降是合理的，因此我們看到今年迄今為止的情況較為溫和。

A couple of points though I'd like to highlight when it comes to the 2025 performance that you see in this quarter. First of all, we highlighted it before but I just want to be clear, it's linked to two elements. In Germany, there is a price effect where there is a significant price decrease due to the change of recommendation.

不過，關於本季中提到的 2025 年業績，我想重點介紹幾點。首先，我們之前已經強調過這一點，但我還是想澄清一下，它與兩個因素有關。在德國，由於推薦意見的改變，會出現價格效應，導致價格大幅下降。

And in the US, it's more what you're mentioning i.e., the sorts. But in both cases, in this 2025 environment, we are keeping a very strong market share performance is overall for Sanofi to vaccines, but in particular, even for differentiates and beyond the performance in terms of market share.

而在美國，更接近你所提到的那種情況，也就是各種情況。但無論哪種情況，在 2025 年的環境下，我們都保持著非常強勁的市場份額表現，這對於賽諾菲的疫苗而言總體上是如此，尤其是在差異化產品方面，市場份額表現更是出色。

What I like to highlight also this quarter in terms of flu is the progress we're also making on an R&D perspective. You see that we have a positive Phase 3 in Fluzone High-Dose 50 plus extension. So with the great performance you've seen with the FLUNITY trial and the fantastic 32% improvement compared to standards and flu specialization.

就流感而言，我還想在本季重點介紹我們在研發方面取得的進展。您可以看到，Fluzone 高劑量 50 加擴展的 3 期臨床試驗取得了積極的結果。因此，您在 FLUNITY 試驗中看到了出色的表現，與標準和流感專科相比，改進幅度高達 32%。

If we can extend that to people above 50 years of it, that will be fantastic to be associated with the progress we've made on pandemic flue with, I think, what are best-in-class H5 so protection results and the move and progress we're making on flu, COVID-19 combination. So flu remains important for us. We're moving forward full team commercially and R&D wise.

如果我們能將這種保護措施推廣到 50 歲以上的人群，那將是極好的，因為這與我們在流感大流行方面取得的進展有關，我認為，H5 是同類產品中最好的，因此可以帶來更好的保護效果，並有助於我們應對流感和 COVID-19 的聯合感染。所以流感對我們來說仍然很重要。我們在商業和研發方面都保持著完整的團隊前進。

Okay. Thank you. Next question, please.

好的。謝謝。下一個問題。

David Risinger, Leerink.

David Risinger，Leerink。

Yes, thanks very much. So congratulations on the positive Inhibrx Elevate results this week. Could you provide some more color on how you would characterize for AATD both the normal range and the trough levels? And then regarding net price prospects for US DUPIXENT in 2026, since your contracting is likely largely complete at this time of the year, how would you characterize the expected net change in pricing in versus the net change in pricing in 2025? Thanks very much.

是的，非常感謝。恭喜您本週 Inhibrx Elevate 檢測結果呈陽性。您能否更詳細地說明一下您如何描述 AATD 的正常範圍和谷值水平？關於 2026 年美國 DUPIXENT 的淨價格前景，由於你們的合約在每年的這個時候可能已經基本完成，您會如何描述 2026 年預期淨價格變化與 2025 年淨價格變化的比較？非常感謝。

Okay, thank you. Inhibrx, AATD, Houman.

好的，謝謝。Inhibrx、AATD、Houman。

Yeah, without running into any embargo issues, you'll remember the definition of alpha antitrypsin levels is related to the wrong crystal nomogram I'll speak in broad terms, standard of care by and large, doesn't get into the normal range for alpha antitrypsin levels. Our Q3 and Q4 molecules provide very commendable 190-milligram levels, both for trough and Linde.

是的，如果沒有遇到任何禁令問題，您應該記得α1-抗胰蛋白酶水平的定義與錯誤的晶體列線圖有關。我概括地說，標準治療總體上無法使α1-抗胰蛋白酶水平達到正常範圍。我們的 Q3 和 Q4 分子在谷濃度和林德濃度方面均能提供非常值得稱讚的 190 毫克水平。

Thank you. And, Brian, I think a clever question from David trying to get at the rebates likely for '26 over '25. But I'll let you answer.

謝謝。布萊恩，我認為大衛提出的這個問題很巧妙，他想了解 2026 年與 2025 年相比可能獲得的退款金額。但我還是讓你來回答吧。

Yes, I think that's a great question, David. Thank you so much for asking it. As you know, we don't typically give guidance on the net price year-over-year. But one thing I will say, as you can see, we've been incredibly disciplined over the years.

是的，我覺得你問得好，大衛。非常感謝你的提問。如您所知，我們通常不會提供年比淨價指引。但有一點我必須說，正如你所看到的，這些年來我們一直都非常自律。

We're now years into the launch of this asset, and it's been captured in our long-term guidance, how we believe the net price will develop over time.

該資產推出至今已有數年，我們的長期指導意見中已經反映了我們對淨價隨時間推移發展趨勢的預期。

Sarita Kapila, Morgan Stanley.

薩里塔·卡皮拉，摩根士丹利。

Just on amlitelimab, how should we think about the upcoming readouts? Is there potential for the placebo arm in the COS2 trial to behave more normally or should we think about it as a pure sister trial for COS1? And then just on story, beyond the no plateau in efficacy that we saw in COS1, what's underpinning the confidence that the long efficacy can improve with time.

單就 amlitelimab 而言，我們該如何看待即將公佈的數據結果？COS2 試驗中的安慰劑組是否有可能表現得更正常，或者我們應該將其視為 COS1 的純粹姊妹試驗？然後，就故事而言，除了我們在 COS1 中看到的療效沒有平台期之外，還有什麼支撐著我們對長期療效會隨著時間的推移而提高的信心呢？

Great questions. Okay, Houman.

問得好。好的，侯曼。

Okay. So I'll take them one at a time. Thank you for the question. Firstly, on case 2, it's a precise replicate -- just to say there are some subtle differences in regional recruitment execution, but essentially, it's a replicate study, and we anticipate and hope that we will get a replicate of COS1.

好的。所以我一個一個來。謝謝你的提問。首先，關於案例 2，這是一個精確的重複研究——只是說在區域招募執行方面有一些細微的差異，但本質上，這是一個重複研究，我們預期並希望我們能夠得到 COS1 的重複研究。

As you'll remember, also, you said correctly on ESTUARY, it's a slightly more nuanced study than has perhaps been observed as well as being able to tell us about durability ultimately in a randomized way. It will also give us a sense of dose variation that we will do.

您可能還記得，您在 ESTUARY 上也正確地指出，這是一項比以往觀察到的更為細緻的研究，並且最終能夠以隨機的方式告訴我們有關耐久性的信息。它還能讓我們了解我們將要進行的劑量變化。

You remember, there are multiple day switching arms, so punchline on SG, which we'll get throughout next year is not only going to tell you about durability, but it will tell you about the relationship between dose and duality. And those are going to be critical in terms of our understanding of transitional around.

你還記得嗎，手臂會一天多次更換，所以關於SG的重點（我們將在明年全年了解）不僅會告訴你耐久性，還會告訴你劑量和雙重性之間的關係。這些對於我們理解過渡時期至關重要。

Okay. Thank you very much, Houman. Yes, we'll see. We'll get the data. We'll see how competitive we are. I think from a commercial perspective, we're very enthusiastic, but we'll let the data read down.

好的。非常感謝侯曼。是的，我們拭目以待。我們會獲取數據。讓我們來看看我們的競爭力如何。從商業角度來看，我們非常熱情，但我們會等待數據公佈。

Okay, next question, please.

好的，請問下一個問題。

Steve Scala, TD Cowen.

史蒂夫·斯卡拉，TD Cowen。

Thank you so much, two questions. Yesterday, Roche said they were taking patients back from ALTUVIIIO. What is the nature of the patient that is being taken back? And what does this mean for ALTUVIIIO's long-term growth outlook?

非常感謝，我有兩個問題。昨天，羅氏表示他們將把病人從ALTUVIIIO接回來。被送回醫院的病人是什麼病情？那麼，這對ALTUVIIIO的長期成長前景意味著什麼？

And the second question is, based on the subgroup data presented at ECTRIMS and the language in today's press release, it seems that any tolebrutinib SPMS approval will be in subgroups what subgroups are likely to be in the final label? And what portion of the overall SPMS market will this represent.

第二個問題是，根據 ECTRIMS 上公佈的亞組數據和今天新聞稿中的措辭，任何 tolebrutinib 治療 SPMS 的批准似乎都將分亞組進行，那麼最終標籤中可能會包含哪些亞組？這將佔整個SPMS市場的多少份額？

Well, Houman, might you deal with that last question because we better clarify that as soon as possible.

侯曼，最後一個問題就交給你來解答吧，因為我們最好盡快澄清這個問題。

Yeah, so just to be clear, I'm going to give you two facts. The SPMS population is about 700 and the Population 120,000 at no point have we entertain the notion of doing subgroups. The regulatory discussions are ongoing, and we don't participate in any further insight during the regulatory discussions.

是的，為了說清楚，我要告訴你兩個事實。SPMS 患者人數約為 700 人，而總人口為 120,000 人，我們從未考慮過進行亞組劃分。監管方面的討論仍在進行中，我們不會參與監管討論期間的任何進一步討論。

Brian, ALTUVIIIO.

Brian，ALTUVIIIO。

Thanks, Steve, so much for the question. So a couple of things. ALTUVIIIO another really strong quarter -- it's becoming very clear to us. This is the number-one switched asset. So it's being switched to -- we are the number-one asset that's being switched to in the Hemophilia marketplace in Hemophilia A.

謝謝你，史蒂夫，非常感謝你的提問。有兩件事。ALTUVIIIO 又一個表現強勁的季度——這一點我們已經非常清楚了。這是交易量最大的資產。所以，我們正在轉向——我們是血友病A市場中被轉向的首選資產。

We're still seeing, as we have shared before in the past, about two-thirds of our switches coming from competitors. Of that, still 10% is coming from HEMLIBRA. So I can't really comment on what Roche shared. But what we are still seeing is 10% is coming directly from HEMLIBRA, and we are the number-one asset that is being switched, too.

正如我們之前分享的那樣，我們仍然看到大約三分之二的交換機來自競爭對手。其中，仍有 10% 來自 HEMLIBRA。所以我無法對羅氏分享的內容發表評論。但我們仍然看到 10% 的資金直接來自 HEMLIBRA，而且我們也是被轉換最多的資產。

Now, about a third of our business is still coming from HEMLIBRA but you can see our overall that's starting to stabilize, and our overall Hem-A business is actually growing quite significantly. So again, we're very pleased with the performance and remain committed to delivering our next blockbuster this year with ALTUVIIIO.

現在，我們大約三分之一的業務仍然來自 HEMLIBRA，但你可以看到我們的整體業務開始趨於穩定，而我們的整體 Hem-A 業務實際上正在顯著成長。所以，我們對這次的成績非常滿意，並將繼續致力於在今年推出我們的下一部重磅作品《ALTUVIIIO》。

Great. Thank you. Next question, please.

偉大的。謝謝。下一個問題。

James Quigley, Goldman Sachs.

James Quigley，高盛集團。

Hello -- sorry, thank you for taking our questions. I've got a follow-up question for François on the DUPIXENT, on the antibody pay away. So I think backing out how the BOI margin seems to have been developing for DUPIXENT, so it looks like last year, it was in the region of sort of 62% this year. The third quarter, it looks like it reached 72%. Again, it's been working backwards, maybe there's like a 92%, 93% gross margin.

您好—抱歉，謝謝您回答我們的問題。我還有一個關於 DUPIXENT 抗體支付的後續問題要問 François。所以我覺得，回顧一下DUPIXENT的BOI利潤率的發展情況，去年似乎在62%左右，而今年則有所上升。第三季度，似乎達到了 72%。再次，情況又回到了原點，毛利率可能只有 92%、93%。

So first of all, is that the right ballpark in terms of what we should be thinking about when calculating the pay away. As you mentioned, it seems not necessarily to be fully reflected in consensus. And going from a 72% operating margin going forward, how should we think about operating leverage obviously going from last year to this year?

首先，就我們計算收益時應該考慮的範圍而言，這個範圍是否正確？正如你所提到的，這似乎並不一定能完全體現在共識中。如果營業利益率從 72% 持續下去，我們該如何看待今年與去年相比的營運槓桿效應？

Looks like there was a big step-up. You mentioned the increase in percentage point growth for the payaway relative to DUPIXENT. So where could the margin go? And how should we think about that going forward or maybe more so where could -- at what point could the margin peak?

看起來有了很大的進步。您提到了相對於 DUPIXENT，支付金額成長百分比有所提高。那麼利潤空間還能去哪裡呢？那麼，我們應該如何看待這個問題，或者更確切地說，利潤率可能在什麼時候達到高峰？

And secondly, maybe one for Brian as well, a follow-up on ALTUVIIIO. You mentioned about taking share from other Factor VIII therapies. Where are you now in terms of the Factor VIII market from a market penetration and market share perspective? Where do you think you're going to end up? And if that's below 100%, given the data, why would that be the case?

其次，也許還可以寫一篇關於 ALTUVIIIO 的後續文章給布萊恩。您曾提過要從其他 VIII 因子療法中分一杯羹。從市場滲透率和市佔率的角度來看，您目前在因子VIII市場處於什麼位置？你覺得你最後會走到哪一步？如果低於 100%，根據數據來看，這是為什麼？

Okay. Well, some highly specific questions, James. Thank you. I think, François, I can ask in a broad into that.

好的。詹姆斯，你問了一些非常具體的問題。謝謝。弗朗索瓦，我想我可以就此提出一個比較廣泛的問題。

James, I would like to help you, but we don't disclose the margin by product and so we don't do it for DUPIXENT for any of our products. So unfortunately, I cannot provide you any information on that. Obviously, the margin has been improving for DUPIXENT over time, given that I mean we are benefiting, obviously, from scale efficiencies, as I said earlier. So our margin has continued to increase.

James，我很想幫助你，但是我們不按產品公佈利潤率，所以我們不會公佈DUPIXENT任何產品的利潤率。很遺憾，我無法提供這方面的任何資訊。顯然，隨著時間的推移，DUPIXENT 的利潤率一直在提高，我的意思是，我們顯然受益於規模效益，正如我之前所說。因此，我們的利潤率持續成長。

Okay. And, Brian, maybe similarly, I don't know how specific you want to be on --

好的。布萊恩，或許也類似，我不知道你想具體到什麼程度。--

Get incredibly specific on that. I mean, what you see in the heme A marketplace is that you've got the factor marketplace, which is, again, as we said, where we continue to take the most business from is the factor marketplace. Again, this is a factor therapy that obviously comes with increased efficacy.

務必詳細說明。我的意思是，你在 HEM A 市場中看到的是因子市場，正如我們所說，我們繼續從因子市場獲得最多業務。再次強調，這是一種療效顯著增強的因子療法。

We are taking some from the nonfactors, as I mentioned before, 10% coming from HEMLIBRA, but we don't know -- we haven't shared exactly where that might end at the end of the day. But again, as we said, we're the number-one asset that is being switched to, so the progress continues, and we'll continue to keep you updated as it develops.

正如我之前提到的，我們從非因素中抽取了一些資金，其中 10% 來自 HEMLIBRA，但我們不知道——我們還沒有透露最終結果會如何。但是，正如我們所說，我們是目前最受關注的資產，所以進展仍在繼續，我們會隨時向您報告最新情況。

And then the last question, I think.

我想，還有最後一個問題。

Peter Verdult, BNP.

Peter Verdult，英國國家黨。

Peter from BNP. Given on the last on the call again, (inaudible) Houman with a few quick pipeline questions. Just on itepekimab Houman, is it simply a case of the go-forward strategy that you repeat the ARIF trial? Or will you solely be looking at the former smokers only. And on FDO, data looks great.

來自英國國家黨的彼得。在上次電話會議上，侯曼再次提出了一些關於管道方面的簡短問題。 （聽不清楚）僅就itepekimab而言，Houman，是否只是簡單地重複ARIF試驗的推進策略？還是您只會關注曾經吸煙的人？FDO上的數據看起來很棒。

You need to get a safe data. But just on the regulatory pathway, if I recall a few years ago, FDA was making some noise about wanting to see your respiratory functional endpoints as well as the biomarker analysis.

你需要取得安全的數據。但就監管途徑而言，如果我沒記錯的話，幾年前，FDA曾表示希望看到你的呼吸功能終點以及生物標記分析。

Is there any of that going to be required for -- and then lastly, on Tolly. SPMS opportunity is huge. But how concerned or not should we be about toll getting an onerous labor requiring weekly liver monitoring? How much of an issue would that be in your mind commercially?

這些是否都需要用到──最後，關於托利。SPMS 的發展前景非常廣闊。但是，對於需要每週進行肝臟監測的繁重勞動，我們該有多擔心呢？從商業角度來看，您認為這會造成多大的影響？

Okay. Last but not least, Okay. Houman.

好的。最後，好的。侯曼。

We look forward to seeing you next week, firstly, to start. Second, let's get into it. Also 3, broadly speaking, we anticipate that we will have to do some form of regulatory trial. The details of exactly what we do have been guided by both internal and external data sets. We've looked broadly trying to understand why 1 and 2 differed and the exact construction of those trials will be dependent on discussions with our beloved partner Regeneron, but also at the regulator.

首先，我們期待下週見到你。其次，讓我們開始吧。另外，3，總的來說，我們預計我們將不得不進行某種形式的監管試驗。我們具體採取哪些措施，是依據內部和外部資料集制定的。我們已經廣泛地研究了為什麼 1 和 2 有所不同，這些試驗的具體設計將取決於與我們親愛的合作夥伴 Regeneron 的討論，以及與監管機構的討論。

So look forward to more on that soon. On EFD, as we call it internally Dora, the -- just to be clear, you're right that the first FDA may have different perspectives. You'll remember that. Current standard of care that is to a target of 11 micromolar which is about 50%, the lower limit of normal of the range and then many patients drop below way below that 3 to 5 days.

敬請期待更多相關消息。關於 EFD（我們內部稱之為 Dora），——需要澄清的是，你說得對，第一個 FDA 可能有不同的看法。你會記得的。目前的治療標準是將​​目標值設定為 11 微摩爾，約佔正常範圍的 50%，然後許多患者會在 3 到 5 天內將血糖降至遠低於該值。

The first point I would make is we will disclose the data at the conference, but the Q3 and Q4 W dosing that we have a substantially better than that. So we will have a conversation with the regulator as to a the intrigue related to those levels, but also on other additional endpoints we'll need pursuant to both natural history data and our open-label extension safety data.

首先我要說明的是，我們將在會議上公佈數據，但我們目前掌握的第三季和第四季的W劑量數據要好得多。因此，我們將與監管機構討論與這些水平相關的疑慮，以及根據自然歷史數據和我們的開放標籤擴展安全數據，我們需要的其他附加終點。

And on your third point on to we're late-stage discussions, as I said, the PDUFA is December 28. And while we anticipate that we'll need some sort of ramps with (inaudible), they can do further disclosable comment on the intensity of (inaudible).

關於你的第三點，我們現在已經到了討論的後期階段，正如我所說，PDUFA 將於 12 月 28 日生效。雖然我們預計我們需要一些坡道（聽不清楚），但他們可以就強度發表更多可披露的評論（聽不清楚）

Maybe on that last point, Houman, it's fair to say, is it that within a lot actually between 51 and 52, I think you touched on that. So we will go. So if you like even better informed. And on poly that first 90 days. So what we did in the credential trial program and what we're doing in real life seems to be very practical and responsible.

侯曼，關於最後一點，可以說，實際上在 51 到 52 之間有很多東西，我想你已經提到了這一點。所以我們會去。所以，如果你想了解更多的話。前90天使用聚苯乙烯。因此，我們在資格認證試驗計畫中所做的，以及我們在現實生活中所做的，似乎都非常務實和負責。

And so I think we're confident we have the right approach, of course, it's the regulator that will decide what that looks like.

所以我認為我們有信心採取正確的方法，當然，最終由監管機構決定具體方案。

Well, okay. Thank you, Peter. Thank you all. Our growth momentum continued in Q3 after 3 quarters of sales and earnings progress, we reiterated our 2025 guidance. Our pipeline delivered important milestones in this quarter as outlined earlier, and finally, as we're looking forward to 2026, we are confident in our ability to pursue our current trajectory of profitable growth. With this, I wish everyone a good autumn and we'll now close the call. Thank you.

好吧。謝謝你，彼得。謝謝大家。在經歷了三個季度的銷售和獲利成長後，我們的成長動能在第三季得以延續，我們重申了2025年的業績指引。如同先前所述，我們的產品線在本季取得了重要的里程碑式進展。最後，展望 2026 年，我們有信心繼續維持目前的獲利成長動能。最後，祝大家秋天愉快，我們的通話到此結束。謝謝。