Sanofi SA (SNY) 2025 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Thomas Kudsk Larsen - Head of Investor Relations

    Thomas Kudsk Larsen - Head of Investor Relations

  • Hello, everyone. This is Thomas Kudsk Larsen from the Sanofi IR team. Welcome to the Q2 2025 conference call for investors and analysts. As usual, you can find the slides on sanofi.com. 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 risks and uncertainties that may cause actual results to differ materially.

    大家好。這是賽諾菲 IR 團隊的 Thomas Kudsk Larsen。歡迎參加 2025 年第二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。請翻到第 3 張投影片。這裡,我們有通常的前瞻性陳述。我們想提醒您,本次電話會議中提供的資訊包含前瞻性陳述,這些陳述受重大風險和不確定性的影響,可能導致實際結果大不相同。

  • 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. As usual, we'll be making comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used by millions of euros and for Q2 2025, unless stated otherwise.

    我們鼓勵您閱讀投影片簡報中的免責聲明。此外,我們建議您參閱我們向美國證券交易委員會提交的 20-F 表格和法國通用註冊文件,以了解這些風險因素的描述。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衡量指標來評論我們的業績。除非另有說明,否則所用數字以百萬歐元為單位,代表 2025 年第二季。

  • Please turn to slide number 4. First, we have a presentation, then we'll take your questions. We have kept the presentation as showed -- as in the past, as other companies report today, and we aim at keeping the call to maximum one hour, all included. For Q&A, we have Brian Olivier, Thomas, to cover our global businesses as well as Roy, our General Counsel and Brendan, Head of Manufacturing and Supply. For the Q&A, you have two options in zoom, raise your hand or submit your question using the Q&A function. With this, I'll hand you over to Paul.

    請翻到第 4 張投影片。首先,我們有一個演示,然後我們會回答您的問題。我們保持了簡報的原樣——就像過去一樣,就像其他公司今天報告的那樣,我們的目標是將通話時間保持在最長一小時,包括所有內容。在問答環節,我們邀請了 Brian Olivier、Thomas(負責我們的全球業務)以及我們的總法律顧問 Roy 和製造與供應主管 Brendan。對於問答,您有兩個選擇:舉手或使用問答功能提交問題。說完,我就把你交給保羅。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Well, thank you, and hello, everyone on the call. We've delivered another strong quarter with double-digit sales growth. Our strategic focus on innovation continues to drive our top line performance with significant contributions from our new launches, vaccines and Dupixent.

    好的,謝謝大家,大家好。我們又一個季度表現強勁,銷售額達到兩位數成長。我們對創新的策略重點持續推動我們的營收表現,新產品、疫苗和 Dupixent 為我們做出了重大貢獻。

  • The performance of our growth drivers made us more confident in our full year business outlook. With that, we've refined our 2025 sales guidance to high single-digit percentage sales growth at constant exchange rates.

    成長動力的表現使我們對全年業務前景更有信心。因此,我們已將 2025 年的銷售預期調整為以固定匯率計算的高個位數百分比銷售成長。

  • Let me highlight the performance of our new launches on slide 6. In Q2, our launch has generated close to EUR1 billion in sales, continuing the momentum we saw in Q1. Altuviiio extended its strong performance, increasing market share through patient switches. The presence of Beyfortus in Southern Hemisphere countries was further expanded in Q2. Keep in mind, these are smaller markets compared to our key launch countries in the Northern Hemisphere.

    讓我在第 6 張投影片上重點介紹我們新產品的表現。在第二季度,我們的產品發布創造了近 10 億歐元的銷售額,延續了第一季的勢頭。Altuiiio 延續了強勁的業績表現,透過患者切換增加了市場份額。Beyfortus 在南半球國家的影響力在第二季進一步擴大。請記住,與我們在北半球的主要發布國家相比,這些市場規模較小。

  • Qfitlia following the FDA approval at the end of Q1 has recorded initial sales uptake has been as expected, and we're pleased to be able to offer an additional treatment option to health care professionals and patients living with hemophilia A or B.

    Qfitlia 在第一季末獲得 FDA 批准後,初始銷售成長符合預期,我們很高興能夠為醫療保健專業人員和患有 A 型或 B 型血友病的患者提供額外的治療選擇。

  • Together, these nine launches now represent 10% of our total sales demonstrating our successful execution in bringing innovative medicines and vaccines to patients. Dupixent sales reached EUR3.8 billion, up 21% in Q2, driven by the continued strong demand and improved indications across geographies. Momentum has been driven by the market growth across all indications where biopenetration remains low as well as by recent launches, including COPD.

    目前,這九種新產品的銷售額占我們總銷售額的 10%,證明了我們在為患者提供創新藥物和疫苗方面取得了成功。受持續強勁的需求和各地區適應症改善的推動,Dupixent 銷售額在第二季達到 38 億歐元,成長 21%。這一發展勢頭是由生物滲透率仍然較低的所有適應症的市場增長以及近期推出的藥物(包括 COPD)所推動的。

  • In the US, sales reached EUR2.8 billion, up 22.7% as Dupixent continues to lead in both new-to-brand prescriptions and total prescriptions across all established indications. The CSU launch is off to a promising start, supported by positive feedback from physicians and patients and broader payer coverage in the first two months.

    在美國,銷售額達到 28 億歐元,成長 22.7%,因為 Dupixent 繼續在所有既定適應症的新品牌處方和總處方中保持領先地位。CSU 的推出取得了良好的開端,得到了醫生和患者的積極反饋以及頭兩個月更廣泛的付款人覆蓋的支持。

  • Outside the US, sales again exceeded the EUR1 billion mark, driven by volume growth in key markets. Eight years after its initial launch in atopic dermatitis, Dupixent continues to demonstrate strong and sustained growth with (inaudible) being its eighth indication approved in the US.

    在美國以外,受主要市場銷售成長的推動,銷售額再次突破 10 億歐元大關。Dupixent 首次用於治療異位性皮膚炎,八年後,該藥物繼續表現出強勁而持續的成長勢頭,(聽不清楚)是其在美國獲準的第八個適應症。

  • Our ongoing efforts in deepening biologic penetration and expanding indications support our ambition of reaching sales of approximately EUR22 billion in 2030, in line with previous communications at Q4. Our vaccine business delivered solid growth in Q2 with sales increasing by 10.3%, driven by the Beyfortus expansion that I just mentioned and benefiting from the effect of a late 2024, 2025, few season in the Northern Hemisphere.

    我們不斷努力深化生物製劑滲透和擴大適應症,以支持我們在 2030 年實現約 220 億歐元銷售額的目標,這與第四季度的先前溝通一致。我們的疫苗業務在第二季度實現了穩健增長,銷售額增長了 10.3%,這得益於我剛才提到的 Beyfortus 擴張,並受益於 2024 年末、2025 年北半球幾個季節的影響。

  • As a reminder, the larger portion of our vaccine business is in the second half of the year due to the seasonality of flu and RSV in key markets in the Northern Hemisphere. Francois will provide our indication for 2025 before a flu vaccine sales in just a minute.

    提醒一下,由於北半球主要市場的流感和呼吸道合胞病毒的季節性,我們的疫苗業務大部分是在下半年。弗朗索瓦將在一分鐘內為我們提供 2025 年流感疫苗銷售前的指示。

  • Our vaccine franchise was further strengthened this quarter by several important R&D and regulatory milestones. A key example is the extended duration of protection for up to six months in the EU label of Beyfortus.

    本季度,我們的疫苗特許經營權因幾項重要的研發和監管里程碑而進一步加強。一個關鍵的例子是 Beyfortus 的歐盟標籤的保護期延長至六個月。

  • And we continue to invest in the future of backseats, most recently entered an agreement to acquire Vicebio. Vicebio would represent a strong strategic fit with our ambition to develop vaccines that can protect together multiple respiratory pathogens. It would also add an innovative technology for combination vaccines, specifically designed for vulnerable groups start the old adults and those at increased risk of severe RSV and HMPV infections.

    我們將繼續投資後座的未來,最近達成了收購 Vicebio 的協議。Vicebio 與我們開發能夠同時保護多種呼吸道病原體的疫苗的雄心壯誌有著很強的戰略契合度。它還將增加一種聯合疫苗的創新技術,專門針對老年人以及嚴重 RSV 和 HMPV 感染風險較高的弱勢群體而設計。

  • Moving to slide 9. The completion of the Blueprint Medicines acquisition just two weeks ago marked a major milestone in our strategic capital redeployment. Blueprint significantly strengthens our position in rare immunology diseases particularly with Ayvakit in systemic mastocytosis, along with a promising pipeline.

    移至幻燈片 9。兩週前完成的 Blueprint Medicines 收購標誌著我們策略資本重新部署的一個重要里程碑。Blueprint 顯著加強了我們在罕見免疫疾病領域的地位,特別是針對系統性肥大細胞增多症的 Ayvakit,以及前景看好的產品線。

  • We are very encouraged by the strong performance of Ayvakit, reaching USD175 million in sales in Q2. While this performance is not included in the Sanofi Q2 financials, it underscores both the high unmet need and Ayvakit's potential as the first approved medicine in advanced and indolent systemic mastocytosis.

    Ayvakit 的強勁表​​現令我們深受鼓舞,第二季的銷售額達到 1.75 億美元。雖然這一業績並未計入賽諾菲第二季度的財務數據,但它凸顯了巨大的未滿足需求以及 Ayvakit 作為首個獲批的治療晚期和惰性系統性肥大細胞增多症的藥物的潛力。

  • The addition of Blueprint brings an established presence among allergists, dermatologists and immunologists, enhancing our ability to advance our own pipeline in immunology. With the acquisition now completed, I would like to formally welcome the talented teams of Blueprint to Sanofi. Together, we look forward to the potential of Ayvakit as one of Sanofi's next blockbusters.

    Blueprint 的加入使我們在過敏症專家、皮膚科醫生和免疫學家中建立了穩固的地位,增強了我們推進自體免疫學研發管道的能力。隨著收購的完成,我謹正式歡迎 Blueprint 的優秀團隊加入賽諾菲。我們共同期待 Ayvakit 成為賽諾菲下一個重磅產品之一的潛力。

  • Here, I'd like to highlight our progress in sustainability leadership. We are proud that time has a game ranked Sanofi as the world's tenth most sustainable company across all industries and number 1 in pharma and biotech.

    在這裡,我想強調一下我們在永續發展領導力方面取得的進展。我們很自豪,《時代》雜誌將賽諾菲評為全球各行業最具永續發展能力的第十大公司,並在製藥和生技領域排名第一。

  • A good example is the eco-design approach we're taking to reduce the environmental footprint of our medicines and vaccines. By 2025, all new medicines and vaccines will incorporate eco design principles, extending to our 20 top sellers by 2030.

    一個很好的例子是我們採取生態設計方法來減少藥物和疫苗對環境的影響。到 2025 年,所有新藥和疫苗都將融入生態設計原則,到 2030 年,這項原則將擴展到我們的 20 種暢銷產品。

  • We're already seeing impressive results with Dupixent to [jail] and Hexaxim through optimized manufacturing, packaging and production. Thank you. I'll now hand over to Francois, our CFO, for more details on the financials.

    透過優化製造、包裝和生產,我們已經看到了 Dupixent 和 Hexaxim 取得的令人印象深刻的成果。謝謝。現在我將把時間交給我們的財務長弗朗索瓦 (Francois),以了解有關財務的更多詳細資訊。

  • François Roger - Executive Vice President, Chief Financial Officer

    François Roger - Executive Vice President, Chief Financial Officer

  • Thank you, Paul, and hello to everyone. As highlighted earlier, net sales increased by 10.1% at constant exchange rate in Q2. This growth was primarily driven by immunology by our pharma launches and by Beyfortus.

    謝謝你,保羅,大家好。如前所述,第二季淨銷售額按固定匯率計算成長了 10.1%。這一增長主要得益於我們推出的免疫學藥物和 Beyfortus 的推動。

  • Gross margin improved by 1.5 percentage points, largely led by an improved product mix and efficiencies. R&D expenses increased by 17.7% due to the lower base of comparison last year with the onetime reimbursement from Sobi.

    毛利率提高了 1.5 個百分點,主要得益於產品組合的改善和效率的提高。由於去年同期基數較低,且有Sobi一次性報銷,研發費用增加了17.7%。

  • Underlying R&D expenses, excluding this reimbursement increased by around 7%. We expect a moderate increase of R&D expenses in H2. Business EPS was EUR1.59, up 8.3%, reflecting our strong sales performance and improved gross margin.

    不包括此項報銷費用在內的基礎研發費用增加了約 7%。我們預計下半年研發費用將適度增加。業務每股收益為 1.59 歐元,成長 8.3%,反映了我們強勁的銷售業績和提高的毛利率。

  • Let me make a few comments beyond Q2 and discuss H1. SG&A is increasing in H1 at around half of the rate of our sales growth and 70% of the increase in SG&A goes to sales and marketing investments to support growth that we have and future launches that are coming. Business EPS in the first six months of the year is up 12%, which is fully supporting our expected strong EPS rebound for the full year 2025.

    讓我對 Q2 以外的一些評論進行一些討論,並討論 H1。上半年銷售、一般及行政費用 (SG&A) 的成長速度約為銷售額成長速度的一半,而銷售、一般及行政費用 (SG&A) 成長的 70% 用於銷售和行銷投資,以支持我們現有的成長和即將到來的未來產品推出。今年前六個月的業務每股收益成長了 12%,這完全支持了我們預期的 2025 年全年每股收益強勁反彈。

  • Moving to the next slide. In Q2, we continue to execute our capital allocation priorities after having received in April around EUR11 billion from the sale of a controlling stake in Opella. We have been actively redeploying this capital. Indeed, we have announced the acquisition of Dren Bio DR-0201, Vigil Neuroscience Blueprint and last week, Vicebio.

    移至下一張投影片。在第二季度,我們繼續執行資本配置優先事項,此前我們於 4 月透過出售歐佩拉控股權獲得了約 110 億歐元的資金。我們一直在積極地重新部署這筆資本。事實上,我們已經宣布收購 Dren Bio DR-0201、Vigil Neuroscience Blueprint 以及上週的 Vicebio。

  • These acquisitions are perfectly aligned with our strategy and meet our three main expectations. First, strategic fit within our core therapeutic areas Second, scientific relevance offering differentiated medicines and vaccines, and third, financial attractiveness.

    這些收購與我們的策略完全一致,並滿足了我們的三大主要期望。首先,與我們的核心治療領域具有策略契合度;其次,提供差異化藥物和疫苗的科學相關性;第三,財務吸引力。

  • Three of our four announced acquisitions reflect our interest in early-stage assets. While Blueprint is at the higher end of our targeted range, we are confident in its strategic value playing both in rare diseases and immunology areas, and we are confident as well in its future financial returns.

    我們宣布的四項收購中有三項反映了我們對早期資產的興趣。雖然 Blueprint 處於我們目標範圍的高端,但我們對其在罕見疾病和免疫學領域的策略價值充滿信心,並且對其未來的財務回報也充滿信心。

  • As previously indicated, early stage opportunities remain our primary interest. However, we always retain the flexibility to slightly expand beyond our preestablished interest when compelling opportunities arise with attractive business cases.

    如前所述,早期機會仍然是我們的主要興趣。然而,當出現具有吸引力的商業機會時,我們始終保持靈活性,可以稍微擴大我們預先設定的興趣範圍。

  • Looking ahead, we retained further capacity for business development on M&A while remaining committed to our AA credit rating. In parallel, we are executing our EUR5 billion share buyback program in 2025 with over 80% already completed as of today. We remain firmly committed to completing the full program by the end of this year.

    展望未來,我們保留了進一步發展併購業務的能力,同時仍致力於保持 AA 信用評級。同時,我們正在執行 2025 年 50 億歐元的股票回購計劃,截至今天已完成 80% 以上。我們堅定地致力於在今年年底前完成整個計劃。

  • Moving to the next slide, I would like to highlight two key components of our ongoing financial performance, namely the Regeneron development balance on the Amvuttra royalties. First, it is important to note that the profit sharing payments to Regeneron are increasing in direct correlation with Dupixent profit growth. These payments are partially offset by the development balance compensation we received from Regeneron.

    進入下一張投影片,我想強調我們持續財務表現的兩個關鍵組成部分,即 Regeneron 開發餘額和 Amvuttra 特許權使用費。首先,值得注意的是,支付給 Regeneron 的利潤分享與 Dupixent 利潤的成長直接相關。這些付款部分被我們從 Regeneron 收到的開發餘額補償所抵銷。

  • As a reminder, Sanofi has historically funded a larger share of Dupixent development costs compared to our partner. Under the agreement, Regeneron reimburses up to 50% of this cumulative cost by deducting them from our profit sharing payments.

    提醒一下,與我們的合作夥伴相比,賽諾菲歷來為 Dupixent 開發成本提供更大份額的資助。根據協議,Regeneron 將以從我們的利潤分享款項中扣除的方式償還高達 50% 的累積成本。

  • Based on current projections, we anticipate this development balance to be fully reimbursed by the end of 2026. This reimbursement arrangement is expected to result in a negative year-on-year BOI impact for Sanofi of approximately EUR300 million in 2026, followed by a more substantial negative BOI impact of approximately EUR800 million in 2027. From 2027 onwards, R&D costs incurred will be shared within the same year.

    根據目前的預測,我們預計到 2026 年底這項發展餘額將全部償還。預計此項報銷安排將對賽諾菲造成 2026 年同比約 3 億歐元的負面影響,並於 2027 年對 BOI 造成更大的負面影響,約 8 億歐元。自2027年起,產生的研發費用將在同一年內分攤。

  • Second, new royalty streams are emerging as an increasingly important margin driver. For example, Amvuttra was recently approved for a new indication in both the US and EU with royalty rights up to 30% of sales.

    其次,新的特許權使用費收入正成為越來越重要的利潤驅動因素。例如,Amvuttra 最近在美國和歐盟獲得了新適應症的批准,專利權最高可達銷售額的 30%。

  • As illustrated on the right-hand side of the slide, the expected royalty revenue of this medicine based on external consensus will have a significant contribution to our financial outlook, probably until the end of the decade.

    如幻燈片右側所示,根據外部共識,該藥物的預期特許權使用費收入將對我們的財務前景產生重大貢獻,可能持續到本世紀末。

  • Let me now give you a little bit more color on some key considerations for the balance of the year. Beyfortus had a strong momentum in 2024 with high vaccine coverage rates in many markets. We anticipate modest growth for 2025 with Q4 sales likely to be roughly similar to Q3.

    現在,讓我向大家詳細介紹今年餘下時間的一些關鍵考慮。2024 年,Beyfortus 發展勢頭強勁,許多市場的疫苗覆蓋率都很高。我們預計 2025 年將出現溫和成長,第四季的銷售額可能與第三季大致相同。

  • For flu, while we anticipate gaining market share, total sales are expected to decrease by a mid-teens percentage versus last year due to competitive forces in particular in the US and in Germany. We anticipate a sales split of about 75% in Q3 and 25% in Q4.

    對於流感,雖然我們預期市場佔有率會增加,但由於美國和德國的競爭力,預計總銷售額將比去年下降百分之十五左右。我們預計第三季的銷售額分成約為 75%,第四季的銷售額分成約為 25%。

  • For the full year 2025, operating expenses may increase slightly due to the previously announced acquisitions. ForEx impact is now estimated to be around minus 4% on sales and around minus 6% on EPS. Other items are similar to what we shared with you last quarter. For the full year 2025, we are now expecting sales growth at a high single-digit percentage at the upper range of our previous guidance.

    2025 年全年,由於先前宣布的收購,營運費用可能會略有增加。目前估計,外匯對銷售額的影響約為-4%,對每股盈餘的影響約為-6%。其他項目與我們在上個季度與您分享的內容類似。對於 2025 年全年,我們目前預計銷售額成長率將達到先前預測的上限,達到高個位數百分比。

  • This refinement of our sales guidance is not linked to Blueprint, which is consolidated by the way, from mid-July 2025, but it is linked to the underlying performance of our business. We confirm our EPS guidance of a low double-digit percentage growth at constant exchange rates. This is also an implied upgrade of our EPS guidance, as we now absorb a few hundreds of millions of additional cost from the newly acquired businesses largely in R&D.

    這次銷售指引的細化與藍圖無關(順便說一下,藍圖將於 2025 年 7 月中旬合併),但與我們業務的基本表現相關。我們確認每股盈餘預期將以固定匯率達到低兩位數百分比成長。這也是我們每股收益指引的隱性升級,因為我們現在從新收購的業務中吸收了數億美元的額外成本,主要用於研發。

  • Finally, we are navigating through a dynamic world with a lot of uncertainties from potential US tariffs and new exports. However, all -- as all the details are still limited and not fully settled yet, we will update you along the way. I now hand over to Houman, who will provide an update on the progress of our innovative pipeline.

    最後,我們正在一個充滿活力的世界中前進,潛在的美國關稅和新出口帶來了許多不確定性。然而,由於所有細節仍然有限且尚未完全確定,我們將隨時向您更新最新情況。現在我把麥克風交給 Houman,他將介紹我們創新管道的最新進展。

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Thank you, Francois. Since our last update, we received US approval for Dupixent in (inaudible) six weeks. And last week, the EU approval of Sarclisa in newly diagnosed transplant-eligible patients. Furthermore, Dupixent were submitted for review in Japan for BP and Cerezyme in the US for Gaucher disease type 3 with an FDA decision expected in January next year.

    謝謝你,弗朗索瓦。自上次更新以來,我們在六週內獲得了美國對 Dupixent 的批准(聽不清楚)。上週,歐盟批准 Sarclisa 用於治療新診斷的適合移植的患者。此外,Dupixent 已在日本提交用於治療 BP 的審批,Cerezyme 已在美國提交用於治療 3 型戈謝病的審批,FDA 預計將於明年 1 月做出決定。

  • Despite especmab's mix Phase III results, our pipeline continues to advance with new AB vaccine showing consistent Phase III efficacy. We secured seven new regulatory designations, including orphan and fast track and had seven medicines featured in prestigious journals, which emphasizes our determination to accelerate our commitment in improving R&D.

    儘管 especmab 的混合 III 期結果不佳,但我們的管道仍在繼續推進,新的 AB 疫苗顯示出一致的 III 期療效。我們獲得了七項新的監管資格,包括孤兒藥和快速通道藥,並有七種藥物在著名期刊上發表,這強調了我們加快改善研發承諾的決心。

  • Last quarter, as Francois said, we acquired DR-201 from Dren Bio, now entering Phase I in immunology. We since made two acquisitions: Blueprint with Ayvakit and two new potential options in mid-stage clinical development, the potential next-generation molecule (inaudible) to masterclass and BLU 808 in inflammatory indications.

    正如 Francois 所說,上個季度我們從 Dren Bio 獲得了 DR-201,目前已進入免疫學第一階段。此後,我們進行了兩次收購:收購了 Ayvakit 的 Blueprint 以及兩個處於中期臨床開發階段的新潛在選擇,即大師班的潛在下一代分子(聽不清)和用於炎症適應症的 BLU 808。

  • And lastly, Vigil with VG-3927, which has the potential to magnify and restore the neuroprotective function of microglia in Alzheimer's disease. We remain committed to expanding our pipeline with more opportunities, both internally and externally.

    最後,Vigil 與 VG-3927 聯合使用,有可能增強和恢復小膠質細胞在阿茲海默症中的神經保護功能。我們將繼續致力於擴大我們的管道,提供更多的內部和外部機會。

  • We're excited about new monoclonal antibody from multiple myeloma, which was recently designated an orphan drug, showcasing our ongoing innovation from our own research in France. Externally, we continue to augment partnerships and collaborations, working hand in hand with the leaders in the field to bring cutting-edge treatment to.

    我們對多發性骨髓瘤的新型單株抗體感到非常興奮,這種抗體最近被指定為孤兒藥,展示了我們在法國自主研究方面的持續創新。在外部,我們持續加強夥伴關係和協作,與該領域的領導者攜手合作,帶來尖端治療。

  • Next slide. We're committed to addressing the large unmet medical need for different COP mutations with Dupixent, with itepekimab and lastly, with (inaudible). At ATS, we presented call data from [borealis] and notice Phase III studies, showing significant reductions in exacerbations, FEV1 improvement and quality of life, confirming our legacy in COPD with Dupixent.

    下一張投影片。我們致力於透過 Dupixent、itepekimab 以及最後的(聽不清楚)。在 ATS 上,我們展示了來自 [borealis] 的通話數據並注意到 III 期研究的結果,結果顯示急性發作次數顯著減少、FEV1 改善和生活品質提高,證實了我們利用 Dupixent 在 COPD 領域取得的成就。

  • For itepekimab targeting former smokers, we're progressing with the data analysis AERIFY-1 and AERIFY-2 Phase III studies, including insights from other molecules targeting the same pathway. And once more advanced, we will discuss with regulatory authorities and provide an update on net steps. The data will be presented at the forthcoming medical.

    對於針對戒菸者的 itepekimab,我們正在推進 AERIFY-1 和 AERIFY-2 III 期研究的數據分析,包括針對同一途徑的其他分子的見解。一旦取得進一步進展,我們將與監管機構進行討論並提供網路步驟的最新資訊。該數據將在即將舉行的體檢中公佈。

  • Lastly, we announced our intention to evaluate (inaudible), our IL-13TSLP pentavalent antibody in a Phase II/III COPD study this season. Based on its benefits seen in existing clinical levy and two known and proven mechanisms of action, we have faith of its dual targeting nanobody technology with strong efficacy and proof of concept due to deeper access into lower respiratory tract or airways. Phase Ib data showed a 40.9% PPV reduction in phenolevels in asthma with patients at day 29. The medicine remains our main interest in respiratory conditions, thanks to its effect on biomarkers incentives.

    最後,我們宣布了我們打算在本賽季的 II/III 期 COPD 研究中評估(聽不清楚)我們的 IL-13TSLP 五價抗體。基於現有臨床應用中觀察到的益處以及兩種已知且已證實的作用機制,我們相信其雙靶向奈米抗體技術具有強大的功效,並且由於能夠更深入地進入下呼吸道或呼吸道而具有概念驗證。Ib 期數據顯示,第 29 天氣喘患者的苯酚水平 PPV 降低了 40.9%。由於該藥物對生物標記激勵的影響,它仍然是我們在呼吸系統疾病方面的主要興趣。

  • Next (inaudible) is emerged as a safe and highly effective platform for rare diseases. The regulatory decision is expected soon for ITP with a target action date for the FDA decision on August 29, 2025. It's received its first global approval recently in the UAE. Moreover, we are pleased by the recent designation received a fast track for IgG4 disease and orphan drug for WAHA and sickle cell disease, all in the US, an orphan designation for IgG4 in the EU.

    接下來(聽不清楚)將成為一個安全且高效的罕見疾病治療平台。FDA 預計很快就會對 ITP 做出監管決定,其目標行動日期為 2025 年 8 月 29 日。它最近在阿聯酋獲得了首次全球批准。此外,我們很高興看到,該藥物最近在美國獲得了 IgG4 疾病的快速通道資格以及 WAHA 和鐮狀細胞疾病的孤兒藥資格,並在歐盟獲得了 IgG4 孤兒藥資格。

  • To complement our presence in rare diseases, at ASCO, we presented the subcutaneous sales data from three studies evaluating the convertibility of Sarclisa administered either by both on-body injector or manual infusions compared to IV results for the study across different lines and regimens, which demonstrated noninferiority with most of the patients preferring the on-body injector. Regulatory submissions are underway with acceptances expected soon.

    為了補充我們在罕見疾病領域的影響力,我們在 ASCO 上展示了三項研究的皮下銷售數據,這些研究評估了 Sarclisa 透過體內注射器或手動輸注給藥的可轉換性,並與不同線和方案的研究靜脈注射結果進行了比較,結果表明非劣效性,大多數患者更喜歡體內注射器。監管提交正在進行中,預計很快就會獲得接受。

  • Finally, at doralprenalpha, our recombinant human AAT 1 fusion protein and a Phase III priority study (inaudible) deficiency aiming for normal function -- normal functional AAT levels with greater convenience. Data is expected H2 2025.

    最後,在 doralprenalpha 中,我們的重組人類 AAT 1 融合蛋白和 III 期優先研究(聽不清楚)缺陷旨在實現正常功能——更方便地達到正常的功能性 AAT 水平。預計數據將於 2025 年下半年公佈。

  • Sanofi is deeply committed to rare diseases. We've established a global franchise with a strong presence in enzyme replacement therapies and hematology, as demonstrated by Altuvio and lastly, fitusiran. Based on the solid foundation, we're expanding our expertise in our pipeline to address the unmet medical need in patients with rare diseases worldwide.

    賽諾菲致力於罕見疾病研究。我們已經建立了全球特許經營權,在酵素替代療法和血液學領域佔有重要地位,Altuvio 和 fitusiran 就是明證。基於堅實的基礎,我們正在擴展我們的專業知識,以滿足全球罕見疾病患者未滿足的醫療需求。

  • Our global reach, combined with our specialized knowledge positions us uniquely to make a significant impact in the lives of those affected by rare disease. Really proud our C1S complement inhibitor for CIDP, which shows promising progress in an area with remaining unmet medical need despite the availability of existing therapies.

    我們的全球影響力加上我們的專業知識,使我們能夠對罕見疾病患者的生活產生重大影響。我們為用於治療 CIDP 的 C1S 補體抑制劑感到非常自豪,儘管現有療法可用,但在仍有未滿足的醫療需求的領域,該抑制劑顯示出良好的進展。

  • At PNS conferences that took place during the second quarter in Edinburgh, Scotland, we presented new long-term extension data from our Phase II study. Carte demonstrated that most patients improved but remain stable and really improve at 24 weeks.

    在第二季度於蘇格蘭愛丁堡舉行的 PNS 會議上,我們展示了第二階段研究的新的長期擴展數據。Carte 證明大多數患者的病情有所改善但仍保持穩定,並在 24 週時真正改善。

  • Results from the Part B confirmed finding across all CIDP patient subgroups, including those who are on standard of care, refractory or naive where patients remain relapse-free and sustain their response at week 76.

    B 部分的結果證實了所有 CIDP 患者亞群的發現,包括接受標準治療、難治性或初治患者,這些患者在第 76 週仍無復發並維持其反應。

  • Patients showed 35% reduction in NFL levels and the stronger certain reduction in complement activity competitive base, really prove out of the potential safe, effective subcutaneous option for CIDP and now also the antibody-mediated rejection with orphan drug designations in Japan for CIDP in the US for AMR.

    患者的 NFL 水平降低了 35%,補體活性競爭基礎的某些降低更為明顯,這確實證明了對 CIDP 來說皮下治療是潛在的安全有效的選擇,並且現在在日本還具有針對 CIDP 的孤兒藥稱號,在美國具有針對 AMR 的稱號。

  • Our Phase III programs include two studies mobilized, it's for patients who have experienced failure or inadequate response to standard of care therapy, which are mostly IVIG or steroids depending on the country and vitalize is the first head-to-head study for patients who are on IVIG and remain partial responders. Currently, both studies expect data from H2 2026.

    我們的 III 期計畫包括兩項動員研究,一項是針對對標準治療療法失敗或反應不足的患者,這些療法大多為 IVIG 或類固醇,具體取決於國家/地區,而 vitalize 是針對使用 IVIG 且仍有部分反應的患者進行的首次頭對頭研究。目前,兩項研究均預計獲得 2026 年下半年的數據。

  • I would like to conclude my usual flow slide for the next 18 months, which includes a new view of 2026 split into two halves. Key upcoming studies include the Phase II (inaudible) in ATD [doctomy] and with Orano and two significant Phase III readouts with tolebrutinib in PPMS and the first data for amuletilumab in AD this year.

    我想總結一下未來 18 個月的常規流程幻燈片,其中包括分為兩部分的 2026 年新觀點。即將進行的關鍵研究包括 ATD [doctomy] 和 Orano 進行的 II 期(聽不清楚)研究,以及今年在 PPMS 中使用 tolebrutinib 進行的兩項重要 III 期讀數,以及在 AD 中使用 amuletilumab 的首批數據。

  • Next year, we expect the remaining Phase III data for ablutilumab in AD, potentially followed by submission. The Q4 dosing in the Phase III study seeking to replicate positive data from the STREAM AD Phase II study with an additional Q12 arm to assess the potential of longer dosing. The dosing is also used in the extension study. Our objective is to explore a more convenient treatment approach in AD with a view as four injections a year, potentially in the maintenance setting.

    明年,我們預計獲得 ablutilumab 在 AD 治療中的剩餘 III 期數據,隨後可能會提交申請。第三階段研究中的 Q4 劑量旨在複製 STREAM AD 第二階段研究中的積極數據,並增加 Q12 組來評估更長時間給藥的可能性。此劑量也用於擴展研究。我們的目標是探索一種更方便的 AD 治療方法,即每年註射四次,並可能在維持治療中。

  • As a reminder, recent results in asthma provided support to longer dosing interval potentially possible with OX40 ligand modulation on top of the AAV Phase II data that suggested sustained efficacy after ending treatment. While not all of our efforts will succeed as there's the nature of drug development, we're confident our skilled teams and advanced digital technologies will drive progress in our core therapeutic areas. I thank our R&D team and colleagues for their achievements and continue to [chasing the miracle] science to improve the lives of patients.

    提醒一下,最近的氣喘研究結果支持透過 OX40 配體調節延長給藥間隔,而 AAV II 期數據顯示在結束治療後仍具有持續療效。雖然由於藥物開發的性質,我們的努力並非都會成功,但我們相信,我們熟練的團隊和先進的數位技術將推動我們核心治療領域的進步。感謝我們的研發團隊和同事們所取得的成就,並將繼續[追逐奇蹟]科學,改善病患的生活。

  • With this, I will hand back to [operator].

    有了這個,我將交還給[操作員]。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Luisa Hector, Berenberg.

    路易莎·赫克托(Luisa Hector),貝倫貝格(Berenberg)。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • Hi, there, thank you for the call. So I wanted to touch on the R&D transformation because we see enormous amounts of progress at Sanofi across the whole organization, but the share price is still lagging. And I think it's awaiting pipeline progress. So on the R&D transformation, I wanted to check your level of confidence given some of your recent successes, but also some more mixed data sets, which are still in-house.

    您好,謝謝您的來電。所以我想談談研發轉型,因為我們看到賽諾菲整個組織取得了巨大進步,但股價仍然落後。我認為它正在等待管道進展。因此,在研發轉型方面,我想根據您最近的一些成功以及一些仍在內部的混合數據集來檢查您的信心水平。

  • And if we go back to your December '23, R&D Day where you laid out some objectives, you were targeting a 50% increase in Phase III trials for this year 2025. You highlighted the new launch cohort with risk-adjusted sales over EUR10 billion in 2030 and your 12 blockbuster assets, of which three of those could be over EUR5 billion. So I wonder if you could just comment on those specifically. Are you on track for the Phase III trials? Are you more confident in your EUR10 billion by 2030? And if so, has the mix changed now that you have more data in-house? Thank you.

    如果我們回顧您在 2023 年 12 月研發日上提出的一些目標,您的目標是到 2025 年將 III 期試驗數量增加 50%。您重點介紹了 2030 年新推出的產品群,其風險調整後的銷售額將超過 100 億歐元,以及 12 項重磅資產,其中三項的銷售額可能超過 50 億歐元。所以我想知道您是否可以對此進行具體評論。你們的第三階段試驗進展順利嗎?您對2030年實現100億歐元目標更有信心嗎?如果是這樣,那麼現在您擁有更多的內部數據,情況是否改變了?謝謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you, Luisa, a very comprehensive. Houman, do you want to get started?

    謝謝你,路易莎,非常全面。霍曼,你想開始嗎?

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Yes. Luisa, thank you for the question. And I'll try to remain succinct. Sanofi has become an R&D-driven company. We are committed to innovation and reserve of patients. And I'm excited by the transformation that takes place. But we have to acknowledge that an R&D transformation is something that doesn't happen overnight. Many in the industry would believe it takes five years to seven years. And I'd like to believe that we're a significant way through that. The proof will be in the pudding, and we remain humble in the face of disease.

    是的。路易莎,謝謝你的提問。我會盡量保持簡潔。賽諾菲已成為一家以研發為驅動力的公司。我們致力於創新和患者的儲備。我對正在發生的轉變感到非常興奮。但我們必須承認,研發轉型不是一朝一夕就能實現的。許多業內人士認為這需要五到七年的時間。我相信我們已經取得了顯著進展。只有實踐才能證明一切,面對疾病我們依然保持謙卑。

  • My -- to answer your question specifically and very directly, of the three big ones that you described that we talked about on the seventh of December 2023, amlatilimab was one of the three as well as (inaudible) we remain committed to all the molecules in our portfolio. Amlitelimab will read out in the relatively near future with its first Phase III. We look forward to pressure testing our predictions. I'll stop there and hand over to Paul.

    我的——具體而直接地回答您的問題,在您描述的我們在 2023 年 12 月 7 日討論的三大藥物中,amlatilimab 是其中之一,而且(聽不清)我們仍然致力於我們產品組合中的所有分子。Amlitelimab 將在不久的將來完成其第一階段的 III 期臨床試驗。我們期待對我們的預測進行壓力測試。我就此打住,把麥克風交給保羅。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Yeah. I mean, I think it's fair to say, we had plenty of time to reflect on the ups and downs of this year. And while not everything has gone our way. The data sets have allowed us to do some good thinking around how to go forward or not as the case may be.

    是的。我的意思是,我認為可以公平地說,我們有充足的時間來反思今年的起起落落。儘管事情並非都如我們所願。這些數據集使我們能夠根據具體情況對如何繼續前進或不繼續前進進行一些很好的思考。

  • I think Houman used the word humble, and I would add to that because I think this transformation has been moving at such a pace that we have spent the recent months, literally going back and kicking the tires to make sure that we have dotted every eye crossed every T on the studies to make sure that we will continue to push science, of course, as expected others.

    我認為 Houman 使用了「謙遜」這個詞,我想補充一下,因為我認為這種轉變進展如此之快,以至於我們花了最近幾個月的時間,逐一檢查,以確保我們在研究中的每一個細節都做到位,以確保我們將繼續推動科學發展,當然,正如其他人所期望的那樣。

  • What we would like to avoid is stubbing our own [time]. So we have some work to do. I think we remain on balance, optimistic about the nature of the big 12 and what that could mean for us. Of course, not everything will work. I'm very pleased with how the transformation has progressed. But I think you're right, by the way, that is for some major remains out that the progress is one thing, but it's revealing itself in successful Phase [IIIs].

    我們要避免的是存根自己的[時間]。所以我們還有一些工作要做。我認為,我們總體上對 12 強的性質以及這對我們意味著什麼持樂觀態度。當然,並不是所有的事情都會成功。我對轉型的進展感到非常滿意。但我認為你是對的,順便說一句,對於一些主要問題來說,進步是一回事,但它在成功的階段中顯現出來[三]。

  • And I think I said this, I think maybe it was you that asked me a question for reflection on a previous call. I'd like to think these things could have been done faster, but I've learned a few things about being patient. So we have to do good work, be diligent, be accurate and factual and then we just have to turn the cards over, and we recognize that we're better just to keep out of drive, get the results, share them and confidence will be built from there.

    我想我說過,我想也許是你在之前的電話中向我提出了一個問題以供反思。我希望這些事情可以做得更快,但我已經學會了一些關於耐心的事情。因此,我們必須做好工作,勤奮,準確,實事求是,然後我們只需要翻開牌,我們認識到我們最好保持動力,獲得結果,分享結果,信心就會從那裡建立起來。

  • Operator

    Operator

  • Richard Vosser, JPMorgan.

    摩根大通的理查‧沃瑟。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Thanks for taking my question. First question, just on development of spend that a little bit higher in the first half on both SG&A and OpEx, obviously, ahead of new launches on SG&A. Just how should we think about the development of that, probably also thinking about '26 as well.

    感謝您回答我的問題。第一個問題,僅就支出發展而言,上半年銷售、一般及行政費用 (SG&A) 和營運支出 (OpEx) 均略有增加,顯然,這高於銷售、一般及行政費用 (SG&A) 的新支出。我們該如何看待它的發展,也可能要考慮 26 年。

  • You potentially have some interesting launches maybe at the at least latter end of that year and in '27. So should we think SG&A goes up from here, R&D as well have we reached a level or with the trials that you're starting, should we expect that and blueprint to go up as well? And how should we think about the margin in '26. Is that sort of at a similar level of '25?

    你可能會至少在那年年底和 27 年推出一些有趣的產品。那麼,我們是否應該認為銷售、一般及行政費用從現在開始上漲,研發費用也已經達到一定水平,或者隨著您開始的試驗,我們是否應該預期藍圖也會上漲?我們該如何看待 26 年的利潤率?這和 25 年的水準類似嗎?

  • And then just a quick bit on Dupixent, a little bit weak in China, maybe, and we've seen that with some products in who have NDRL listing in China and some pressure in that market. Just thoughts about China, Dupixent then the rest of the portfolio and how we should think about the growth there going forward? Thanks very much.

    然後簡單談談 Dupixent,它可能在中國市場表現有點弱,而且我們已經看到一些在中國已列入國家醫保目錄的產品面臨一些市場壓力。只是考慮一下中國、Dupixent 以及投資組合的其他部分,以及我們應該如何看待未來那裡的成長?非常感謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thanks, Richard. I think -- and it's a couple of questions we've had throughout the day all morning. SG&A, R&D spend, of course, a little bit higher in the quarter. Francois, where do you think -- how can you guide?

    謝謝,理查。我認為——這是我們今天早上討論過的幾個問題。當然,本季的銷售、一般及行政開支和研發開支略高一些。弗朗索瓦,您認為-您如何引導?

  • François Roger - Executive Vice President, Chief Financial Officer

    François Roger - Executive Vice President, Chief Financial Officer

  • Richard, it's a good question, Francis speaking. On R&D, obviously, I mean, we reported an increase of 17% in the quarter. But if you put aside the exceptional item that exceptional revenue that we had from Sobi last year, it's 7% underlying.

    理查德,這是個好問題,我是法蘭西斯。在研發方面,顯然,我的意思是,我們報告本季成長了 17%。但如果你把去年我們從 Sobi 獲得的特殊收入這一特殊項目放在一邊,它的潛在收益是 7%。

  • As I said earlier, we expect to be probably around flat, maybe slightly up in R&D in the later part of the year. So we will be for the full year where we said we would be, which is slightly off of the full year. There might be a little bit of additional cost as well coming from Blueprint, but I mean, again, the guidance that we gave at the beginning of the year, we will be there.

    正如我之前所說,我們預計今年下半年研發支出可能會持平,甚至略有上升。因此,我們的全年業績將與我們所說的一致,但略有偏差。藍圖可能還會帶來一些額外成本,但我的意思是,我們會按照年初給的指導去做。

  • So there is a little bit of a phasing issue between H1 and H2 have no concern whatsoever. On SG&A, you can see some increase as well. Just to give you a perspective, I mentioned it earlier, we have a rate of increase of SG&A, which is half of our increase in sales, which means that we are benefiting from growth leverage. Do expect that to continue in the future.

    因此,H1 和 H2 之間存在一點點階段問題,但完全不用擔心。在銷售、一般及行政費用方面,你也會看到一些成長。只是為了給你一個視角,我之前提到過,我們的銷售、一般及行政費用的成長率是我們銷售額成長的一半,這意味著我們正受益於成長槓桿。確實希望這種情況在未來能夠持續下去。

  • And if you look at it, 70% of the increase that we experienced in the first half went to an investment in sales and marketing to get growth, which we have to prepare for future launches. So I think it's very healthy because we are in an investment position. Do expect that to continue as well. To give you a little bit more color, I don't want to go into guidance for '26 because it's too early and it's not the right time to do that.

    如果你看一下,你會發現我們上半年成長的 70% 用於對銷售和行銷的投資以實現成長,我們必須為未來的推出做好準備。所以我認為這非常健康,因為我們處於投資地位。確實希望這種情況能夠持續下去。為了給您更多信息,我不想討論 26 年的指導,因為現在還為時過早,現在不是這樣做的正確時機。

  • But just to give you a direction of travel, we do expect in the next couple of years to enjoy an attractive growth profile until 2031 at least. We will have a tight control on cost, which means basically G&A more or less flat.

    但只是為了給您一個旅行的方向,我們確實預計在未來幾年內至少到 2031 年將享受有吸引力的成長概況。我們將嚴格控製成本,這意味著一般及行政開支基本持平。

  • Sales and marketing up, but probably certainly at a lower level than sales. R&D will be certainly slightly up, although they want to be very careful. It will depend on readouts and it may be impacted a little bit as well by some acquisitions in BD and M&A.

    銷售和行銷有所上升,但可能肯定低於銷售額。儘管他們希望非常謹慎,但研發投入肯定會略有增加。這將取決於讀數,也可能受到 BD 和 M&A 中的一些收購的影響。

  • So we don't have necessarily the full visibility of what where we can go year-by-year at this point in time. But anyway, given that we will get some growth leverage, do you expect OI to increase year after year in absolute value in the next coming years? Once again, largely as a consequence of an attractive growth profile in sales with a benefit -- with tight control on cost and growth leverage. We'll get that in '25 and we'll get it in the coming years as well.

    因此,我們目前還不一定能完全預見到我們每年能夠取得什麼進展。但無論如何,考慮到我們將獲得一些成長槓桿,您是否預計未來幾年 OI 的絕對值會逐年增加?再一次,這主要是由於銷售成長前景誘人且具有優勢——嚴格控製成本和成長槓桿。我們將在2025年實現這一目標,並且在未來幾年內也將實現這一目標。

  • That will give us space to absorb some specific items, such as the Houman and I mentioned earlier, in the next couple of years, like the Regeneron end of R&D reimbursement. That one we will be able to absorb in BOI. So do expect to see BOI increasing year after year. And I'm very confident about it.

    這將使我們有空間在未來幾年內吸收一些特定項目,例如 Houman 和我之前提到的,例如 Regeneron 終止研發報銷。我們將能夠吸收BOI的人才。因此,預計 BOI 將逐年成長。我對此非常有信心。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you, Francis. I think well said attractive growth profile, tight management on OpEx, R&D broadly flat, depending on successes or the opposite in R&D for this year and will be on we'll see. And we overlaid that with the -- being one of the companies with the lowest genericization profiles over the next five, six, seven, eight years. So it's important that we advance the medicines that drive the growth and then fund the launches.

    謝謝你,法蘭西斯。我認為,有吸引力的成長前景、嚴格的營運支出管理、研發基本持平,取決於今年研發的成功或失敗,我們拭目以待。我們將此與未來五、六、七、八年內通用化程度最低的公司之一進行比較。因此,重要的是我們要推進推動成長的藥物,然後為產品發布提供資金。

  • But I think we've come a long way as the team reshaping the business, but we have to be extremely prudent with how we deploy those investments because we want increasingly profitable growth, it's just obvious. Brian, Dupixent China.

    但我認為,隨著團隊重塑業務,我們已經取得了長足的進步,但我們必須非常謹慎地部署這些投資,因為我們希望實現越來越高的利潤成長,這是顯而易見的。Brian,Dupixent 中國。

  • Brian Foard - Executive Vice President, Head of Specialty Care

    Brian Foard - Executive Vice President, Head of Specialty Care

  • Well, thank you, Richard, so much for the question. And I'll come to China in just a second. As you probably know Dupixent is a pretty diversified product now around the world, a bunch of different indications. We're in eight as Carl alluded to already in the United States. And so while China is a very important marketplace, it is one of many where we're actually seeing continued underlying volume growth.

    好吧,理查德,非常感謝你提出這個問題。我馬上就來中國。您可能知道,Dupixent 目前在世界各地是一種相當多樣化的產品,具有多種不同的適應症。正如卡爾所提到的,我們在美國已經排到了第八位。因此,雖然中國是一個非常重要的市場,但它只是我們看到的持續潛在成長的眾多市場之一。

  • And so I'd first start there. Actually, in China, we've seen more than 30% volume growth in China. So really positive in China right now. Of course, as you mentioned, we will have pricing pressures from time to time in market as is normally the case and as we planned for. And we will grow through the Real actually eventually. But as we get more access to more indications in China, this is going to be a really important marketplace for us moving forward, but one of many.

    所以我首先從那裡開始。事實上,在中國,我們已經看到銷量成長超過30%。所以目前中國的情況確實很正面。當然,正如您所說,市場上時不時會存在定價壓力,這是正常情況,也是我們計劃好的。我們最終將透過現實而成長。但隨著我們在中國獲得更多適應症,這將成為我們未來發展的一個真正重要的市場,但只是眾多市場之一。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay. Next question please.

    好的。請問下一個問題。

  • Operator

    Operator

  • Matthew Weston, UBS.

    瑞銀的馬修·韋斯頓。

  • Matthew Weston - Analyst

    Matthew Weston - Analyst

  • Thank you. Two questions for me, please. One is on amlitelimab. and Houman, if I'm a leading AD prescriber, I'd love to know what you think I want to see from amlitelimab? Do I want more efficacy than up? Do I want more efficacy than Dupi subgroups? Or is it really about looking for the same efficacy as Dupi with that better duration of treatment?

    謝謝。請問我兩個問題。一個是關於 amlitelimab 的。 Houman,如果我是 AD 的主要處方者,我很想知道您認為我希望從 amlitelimab 中看到什麼?我想要比上升更高的功效嗎?我是否想要比 Dupi 亞組更有效?或者真的是為了尋求與 Dupi 相同的療效,但治療時間更長?

  • And then just one finance question. The additional comment on tariffs. I think the comment was that there was a lot that was unknown. Have you assumed thing in guidance for 2025? Or have you assumed the basic level that's being discussed in the current EU, US trade deal? Or just you moved so much inventory, it doesn't matter this year? Thank you.

    然後只有一個財務問題。關於關稅的補充評論。我認為評論說有很多事情是未知的。您是否在 2025 年的指導中考慮過一些事情?或者您已經假設了當前歐盟和美國貿易協議中正在討論的基本水平?或者只是你轉移了那麼多庫存,今年沒關係?謝謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Let's start there, Francois.

    我們從那裡開始吧,弗朗索瓦。

  • François Roger - Executive Vice President, Chief Financial Officer

    François Roger - Executive Vice President, Chief Financial Officer

  • Yes, Matthew, anyway, it's difficult to comment on what we don't know. But we have run different scenarios, obviously. And we have -- based on what is widely reported in the media, we have looked at the impact that it could have in 2025, given that we're already fairly well advanced in the year. And we confirm -- we did not factor it in our guidance, but it will have a limited impact on 2025 because we already have inventory in place in the US. So I don't think that it will -- in fact, with what we know today and what we read in the media, we don't think that it will impact our guidance in any way for commitments.

    是的,馬修,無論如何,對於我們不知道的事情很難發表評論。但顯然,我們已經運行了不同的場景。根據媒體的廣泛報道,我們已經研究了它在 2025 年可能產生的影響,因為這一年我們已經取得了相當大的進展。我們確認——我們沒有將其納入我們的指導範圍,但它對 2025 年的影響有限,因為我們在美國已經有足夠的庫存。所以我不認為會這樣——事實上,根據我們今天所了解的情況和我們在媒體上讀到的內容,我們認為它不會以任何方式影響我們對承諾的指導。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you. Houman, what are you expecting to see?

    謝謝。Houman,你期望看到什麼?

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • So thanks for the question. Taking that back. I think it's important to think about the atopic dermatitis landscape. And it remains a matter of some concern to me that only 15% or 16% of patients with atopic dermatitis, which who are biologically biologic eligible or currently receiving therapies, both from our own molecules and those of other pharmaceutical companies.

    感謝您的提問。收回剛才的話。我認為考慮異位性皮膚炎的情況很重要。令我感到擔憂的是,只有 15% 或 16% 的異位性皮膚炎患者符合生物製劑治療條件或目前正在接受治療,這些治療既包括我們自己的分子治療,也包括其他製藥公司的分子治療。

  • We welcome new molecules in the space. And I think a leading KOL in the atopic dermatitis space and beyond, will welcome more options for their patients. Speaking specifically about amlitelimab, the value that we see in this space is that there are a variety of patients that are highly heterogenous and need a variety of solutions, including the fact that agents -- patients who are refractory to current agents demonstrate upregulation of OX40 ligand in skin boxes.

    我們歡迎這個領域的新分子。我認為,異位性皮膚炎領域及其他領域的領先 KOL 將為他們的患者提供更多選擇。具體來說,就 amlitelimab 而言,我們在這個領域看到的價值在於,有各種各樣的患者,他們具有高度的異質性,需要各種各樣的解決方案,包括這樣的事實——對目前的藥物有抵抗力的患者在皮膚盒中表現出 OX40 配體的上調。

  • What does that lead us to believe, all in all, the distillate of that is that I think that a new agent that comes in, consistent with our stream AV work that we've previously published that provides both a longer interval of treatment, coupled with magnitude of treatment consistent with the standard of care would be significantly and hugely favored in the marketplace.

    總而言之,我認為,如果出現一種新的藥物,與我們之前發表的流 AV 工作一致,既能提供更長的治療間隔,又能提供與護理標準一致的治療強度,那麼這種藥物將在市場上受到極大的青睞。

  • One other final comment, newer agents that have significantly lower efficacy than the standard of care have already garnered substantial interest. So a molecule that is comparable to the standard account will be with a longer interval very substantially of value.

    最後還有一點要說的是,療效明顯低於標準治療的新藥已經引起了人們的極大興趣。因此,與標準帳戶相當的分子將具有更長的價值間隔。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Yeah. I think -- thanks, Houman. I think if you look at Stream AD design, we had another arm to explore longer intervals that we'd love to see what that could that -- we'll see the data will tell us. Okay. Next question.

    是的。我想——謝謝,Houman。我認為,如果您看一下 Stream AD 設計,我們還有另一個分支來探索更長的間隔,我們很樂意看到它能帶來什麼——我們將看到數據會告訴我們什麼。好的。下一個問題。

  • Operator

    Operator

  • Next question from Florent Cespedes from Bernstein. Okay. Let's take the next question in between. Next question from in [Xue Chen] from Barclays.

    下一個問題來自伯恩斯坦的弗洛朗·塞斯佩德斯 (Florent Cespedes)。好的。讓我們來討論一下中間的下一個問題。下一個問題來自巴克萊銀行的[Xue Chen]。

  • Xue Chen - Analyst

    Xue Chen - Analyst

  • Hi, can you hear me?

    嗨,你聽得到我說話嗎?

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Yeah.

    是的。

  • Xue Chen - Analyst

    Xue Chen - Analyst

  • H, thank you for taking my question. So I have a question on flue. You guided a meeting line primarily due to price pressure. Could you please provide more color on how Sanofi plans to mitigate this aggressive pricing dynamic across multiple markets? And how are you thinking about the longer-term pricing dynamics in flu? And also on top of that, how do you find so far IFP Junior leadership impact on the fuel business in the US.

    H,感謝您回答我的問題。所以我有一個關於煙道的問題。您引導的會議路線主要由於價格壓力。您能否詳細介紹一下賽諾菲計劃如何在多個市場緩解這種激進的定價動態?您如何看待流感的長期定價動態?除此之外,您認為到目前為止 IFP Junior 領導階層對美國燃料業務有何影響?

  • And maybe on top of that, just you guided high single digit for the top line, given the slow headwinds that you have already flat. I think it actually shows a resilient business on the top line at least. So can you please walk us through your confidence to reach that top end? And like what -- which franchise will be doing the heavy lifting in the second quarter? Any color would be appreciated. Thank you.

    或許除此之外,考慮到你們已經平穩的緩慢逆風,你們僅指導了高個位數的營收成長。我認為這至少表明業務收入具有韌性。那麼,您能否向我們介紹一下您達到這一頂峰的信心?那麼──哪一支球隊將在第二季承擔重任?任何顏色都會受到歡迎。謝謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thomas?

    托馬斯?

  • Thomas Triomphe - Executive Vice President, Vaccines

    Thomas Triomphe - Executive Vice President, Vaccines

  • Thanks for your question, Xue. On the second part of your first question, so I don't have any specific comment on the new administration view on flu. But I can give you a bit more color on how we are seeing the full flu year in 2025. As we've mentioned and you were making addition to it, we foresee in 2025 decrease of our sales in the mid-teens percentage range, with a Q3 to Q4 speed of 75%, 25% split.

    謝謝你的提問,薛。關於你的第一個問題的第二部分,我對新政府對流感的看法沒有任何具體評論。但我可以向您詳細介紹一下 2025 年整個流感年的情況。正如我們所提到的以及您所補充的,我們預計 2025 年我們的銷售額將下降百分之十幾,第三季到第四季的降幅分別為 75% 和 25%。

  • You completely understood that it's linked to competitive pricing pressure with -- let me give you some color around it. First of all, there is a one-off impact in Germany. So it's a one-off effect of 2025 only and will not duplicate it moving forward, which is the fact that within the flu recommendation for elder in Germany, there is the addition of an adjuvanted competitor, which automatically reset the price at approximately half what the price was in the previous year. So there's a one-off there in 2025.

    您完全理解這與競爭性定價壓力有關——讓我告訴您。首先,對德國的影響是一次性的。因此,這只是 2025 年的一次性影響,並且不會在未來重複出現,事實上,在德國針對老年人的流感建議中,增加了一種佐劑競爭對手,這會自動將價格重置為前一年價格的一半左右。所以 2025 年會有一次性事件發生。

  • The second part of that overall decrease for the year is linked to competitive pricing pressure, mostly in the US and a little bit in the international zones. I think there are a couple of points that are important here to highlight. First of all, we are a significant leader in the market. And let's be very clear, we expect our market share in the to be a solid market share performance in 2025 despite this declining market in value.

    今年整體下降的第二部分與競爭性定價壓力有關,主要在美國,也有少量在國際地區。我認為這裡有幾點需要強調。首先,我們是市場上的重要領導者。讓我們明確一點,儘管市場價值正在下降,但我們預計到 2025 年我們的市佔率仍將保持穩固的表現。

  • Again, maintaining our fuller ship position, which obviously comes from the fact that we have a very strong differentiated portfolio with (inaudible) Flublok. As for the long term, well, I think that's quite in line with what we had in due, and that's why we've made the deal with Novavax and (inaudible) because the way we foresee the market to evolve is, first of all, to keep evolving towards more differential vaccines like the ones we have, but provide strong efficacy and good safety profile.

    再次,保持我們更完整的船舶位置,這顯然源於我們擁有(聽不清楚)Flublok 非常強大的差異化產品組合。至於長期來看,嗯,我認為這與我們應有的水平相當一致,這就是我們與 Novavax 達成交易的原因,(聽不清楚)因為我們預見市場發展的方式是,首先,繼續朝著像我們現有的疫苗一樣更具差異化的疫苗方向發展,但要提供強大的功效和良好的安全性。

  • And top of that, moving forward to combination, where again, you will be able to meet the quality in terms of efficacy of the differentiator vaccines, but of course, also the tolerability profile. And I think that with our fluke covid 19 portfolio in development, we have a good chance to get there.

    最重要的是,透過聯合用藥,您將能夠再次滿足差異化疫苗功效方面的品質要求,當然,也能滿足耐受性方面的品質要求。我認為,隨著我們僥倖逃脫的新冠肺炎 (covid 19) 投資組合的開發,我們很有機會實現這一目標。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you, Francois.

    謝謝你,弗朗索瓦。

  • François Roger - Executive Vice President, Chief Financial Officer

    François Roger - Executive Vice President, Chief Financial Officer

  • And Surely, on the question about lending in terms of sales growth for the full year, Indeed, we confirm our confidence for the high single-digit level for the full year. First and foremost, we did 9.9% in H1. It does help for the full year.

    當然,關於全年銷售成長貸款的問題,我們確實對全年高個位數成長水準充滿信心。首先,我們上半年的業績達到了 9.9%。它確實對全年有幫助。

  • Second, we will continue to have a strong growth with Dupixent. Don't forget that we were at 21% of value growth in Q2. It's amazing. By the way, it's even in the mid-20s by volume eight years after the launch, really impressive. It's not only Dupixent, we are not Dupixent dependent launches, they contributed 10% of sales, but they also contributed in Q2, almost 1/4 of our growth and is gaining traction quarter after quarter.

    其次,我們將繼續與 Dupixent 保持強勁成長。不要忘記,我們第二季度的價值成長了 21%。太神奇了。順便說一句,推出八年後,其銷量仍達到 25 左右,這確實令人印象深刻。不僅僅是 Dupixent,我們並不是依賴 Dupixent 推出產品,它們貢獻了 10% 的銷售額,而且它們在第二季度也貢獻了我們幾乎 1/4 的成長,並且每個季度都在獲得發展動力。

  • And we have a resilient Gen Med business or established product are very resilient as well. So we do confirm our high single-digit guidance for the full year. Let's be careful with Q3. We have flagged it already since the beginning of the year. We had very high counts last year in Q3.

    而且我們擁有具有彈性的 Gen Med 業務或成熟產品,它們也具有很強的彈性。因此,我們確實確認了全年高個位數的預期。讓我們小心對待 Q3。我們從今年年初就已經對此進行了標記。去年第三季我們的計數非常高。

  • So do expect to see a little bit of a slowdown in Q3 in terms of growth versus what we have experienced in H1, but once again, full confidence with high single digit. By the way, I take the opportunity to say it it's high single digit with and without a Blueprint. So it's not coming from Blueprint, high single digit is coming from the best business.

    因此,與上半年相比,我們確實預計第三季的成長會略有放緩,但我們對高個位數的成長充滿信心。順便說一句,我藉此機會說一下,無論有沒有藍圖,它都是高個位數。所以它不是來自藍圖,高個位數來自最好的業務。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you. Next question.

    謝謝。下一個問題。

  • Operator

    Operator

  • Florent Cespedes, Bernstein.

    弗洛朗·塞斯佩德斯、伯恩斯坦。

  • Florent Cespedes - Analyst

    Florent Cespedes - Analyst

  • Yes. Good afternoon. Thank you for taking my question. Two, please. First, on Dupixent, could you maybe give a little bit more color on the ramp-up in COPD as now we have the product available in certain countries and six more to come. Could you share with us if -- where you see the best adoption in this disease? That's my first question.

    是的。午安.感謝您回答我的問題。請給我兩份。首先,關於 Dupixent,您能否詳細介紹一下其在 COPD 治療方面的進展?目前,該產品已在某些國家上市,即將在另外 6 個國家上市。您能否與我們分享一下—您認為這種疾病的最佳治療方法在哪裡?這是我的第一個問題。

  • Second question for Paul on -- with the recent Blueprint acquisition, and late-stage products. Is it fair to assume that in the future, you will look for earlier phase assets and the transaction at more on what you used to call bolt-on around EUR2 billion to EUR5 billion. Any color on that would be great. Thank you.

    第二個問題是問保羅——關於最近的 Blueprint 收購和後期產品。是否可以公平地假設,在未來,您將尋找早期階段的資產,並且交易額將更多地集中在您過去所說的約 20 億歐元至 50 億歐元的附加資產上。任何顏色都可以。謝謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you. Brian?

    謝謝。布賴恩?

  • Brian Foard - Executive Vice President, Head of Specialty Care

    Brian Foard - Executive Vice President, Head of Specialty Care

  • Yes. So thank you so much for your question. And first and foremost, the double-digit growth that we've seen, just as Francois just said, really comes from across indications, across geographies. Our base business -- actually, our base indications of atopic dermatitis, asthma, nasal pulp, some of the first indications, we continue to see strong growth there. But it is really exciting to see also growth coming from new indications, such as COPD, CSU and even recently, BP.

    是的。非常感謝您的提問。首先,正如弗朗索瓦剛才所說,我們所看到的兩位數成長確實來自不同適應症、不同地理。我們的基礎業務——實際上,我們的基礎適應症是異位性皮膚炎、氣喘、鼻塞,其中一些首批適應症,我們繼續看到強勁成長。但看到 COPD、CSU 甚至最近的 BP 等新適應症也帶來成長,確實令人興奮。

  • Now specifically as it relates to COPD, about nine months into the launch, we continue to see excitement from customers. And again, as a reminder, these are customers, these are really largely pulmonologists that have had a great deal of experience with Dupixent in asthma previously. So the best way to look at this is if you really look at the pulmonologists community and you look at how their prescriptions have changed, our volume has really grown strongly in the [poems] offices. Thanks to the launch of COPD in combination, of course, with asthma.

    現在具體到與 COPD 相關的內容,推出大約九個月後,我們繼續看到客戶的興奮。再次提醒一下,這些都是顧客,實際上大部分都是肺部疾病專家,他們之前在使用 Dupixent 治療氣喘方面有著豐富的經驗。因此,看待這個問題的最好方式是,如果你真正關注肺病專家群體,並關注他們的處方是如何變化的,我們[詩歌]辦公室的業務量確實大幅增長。當然,這要歸功於 COPD 與氣喘的合併治療。

  • And of course, that is, again, really positively and will continue to develop over time. So really, really positive start to the launch of COPD, and we're seeing this pretty consistently across the markets, as you mentioned, 13 and 6 more to go before the end of the year for launching in COPD.

    當然,這再次表明情況確實十分積極,並且會隨著時間的推移而繼續發展。因此,COPD 的推出確實取得了積極的開端,而且正如您所說,我們在各個市場上都看到了相當一致的情況,今年年底前,COPD 的推出將有 13 個新藥和 6 個新藥。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you, Brian. On the second part that we've guided for quite a while on the 2% to 5% range. We had said for maybe the last year or two, we'd step outside for the right opportunity, but first single digit. The blueprint opportunity was right in the sweet spot for us on this immunology, rare access.

    謝謝你,布萊恩。對於第二部分,我們已經在 2% 到 5% 的範圍內進行了相當多的指導。我們曾經說過,也許在過去的一兩年裡,我們會走出去尋找合適的機會,但首先是一位數。對我們來說,藍圖機會在免疫學這一罕見領域正處於最佳時機。

  • And we felt like we were quite uniquely positioned to be able to build on the great work the Blueprint team had done and to really move quickly based on our experience, one of the world's leading rare disease companies.

    我們覺得我們處於非常獨特的地位,能夠在 Blueprint 團隊所做的出色工作的基礎上繼續前進,並根據我們的經驗迅速採取行動,我們是世界領先的罕見疾病公司之一。

  • And I think -- don't forget that it's literally just in the launch phase. And of course, with lanestinib behind that and perhaps even more of a more out of the -- more of a complicated but intriguing step is an away further back, it could be a game changer. Of course, these things could disappear quitely end to the note. But we feel like it really matched what we were trying to do.

    我認為——別忘了它實際上還處於啟動階段。當然,有了 Lanestinib 的支持,甚至可能更加出乎意料——更複雜但有趣的一步是進一步的發展,它可能會改變遊戲規則。當然,這些東西也可能會在紙條結束時消失。但我們覺得它確實符合我們想要做的事情。

  • As for deals going forward, we sort of reiterate you might say you just did Blueprint, but we get back into the 2% to 5% range, not because of the financial piece, but because we continue to look early, early, early, and they tend to be in that range.

    至於未來的交易,我們重申一下,您可能會說您剛剛完成了藍圖,但我們又回到了 2% 到 5% 的範圍內,這並不是因為財務部分,而是因為我們繼續儘早、儘早、儘早地尋找,而且它們往往處於這個範圍內。

  • And we want to maintain our AA rating or at least we have flexibility there to do that. Francois said that our growth profile for the next five years-plus, is in the top group of the industry. So it's really -- the emphasis remains early, early, early, but in the areas that we are strong in where the marginal cost to deploy new asset would be modest.

    我們希望保持我們的 AA 評級,或者至少我們可以靈活地做到這一點。弗朗索瓦表示,我們未來五年以上的成長前景將處於行業領先地位。所以,重點仍然是儘早,儘早,但在我們實力雄厚的領域,部署新資產的邊際成本會適中。

  • We just want to keep adding to that because as we get into the early 30s, as you know, depending that's when we need to be and launch swing some of these assets, so it's better to go early. So I think we're trying to be disciplined. We spend a lot of time on this. and we're very particular about what we think meets our bar. And I think we're happy with how we sit. Okay. Next question.

    我們只是想繼續增加這一點,因為當我們進入 30 年代初期時,正如你所知,這取決於我們需要在什麼時候推出其中一些資產,所以最好儘早行動。所以我認為我們正在努力保持紀律。我們在此上花費了大量的時間,並且對於符合我們標準的內容非常講究。我認為我們對自己的坐姿很滿意。好的。下一個問題。

  • Operator

    Operator

  • Sachin Jain, BofA.

    美國銀行的 Sachin Jain。

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Hi there. Thanks for taking my questions. A couple of product ones and then one clarification for me. So on amlitelimab, the answer prior question you flagged the importance of less frequent dosing. We haven't seen, I don't think the Q1 we asphadata. So just any color you can give on the strength of that data and read to AD. I just wanted to be clear that you put the Q2 quick data in the AD press release as I think it's a secondary end point. That's the first question.

    你好呀。感謝您回答我的問題。有幾個產品,然後為我澄清一下。因此,關於 amlitelimab,您在回答先前的問題時就強調了減少給藥頻率的重要性。我們還沒看到,我不認為 Q1 是我們的 asphadata。所以,您可以根據這些數據的強度給出任何解釋,並將其解釋給《美國商業周刊》。我只是想明確說明,您把第二季的快速數據放在了《美國商業周刊》的新聞稿中,因為我認為這是一個次要的終點。這是第一個問題。

  • Second question on [how to breach] in SPMS. As you approach approval, just what should our expectation for [rimsby] how that might impact launch -- and then just a quick clarification on a prior question on the BOI for '26, '27. So in no doubt, should we see margin growth as well as absolute growth. I heard the answer as a comment on absolute BOI and I think the question was on the margin. Thank you.

    第二個問題是關於 SPMS 中的 [如何突破]。當您接近獲得批准時,我們對 [rimsby] 的期望是什麼?這將如何影響發布?然後,我們快速澄清一下先前關於 26 年、27 年 BOI 的問題。因此毫無疑問,我們應該看到利潤率成長和絕對成長。我聽到的答案是對絕對 BOI 的評論,我認為這個問題處於邊緣。謝謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay. Thank you. Let's give us to Houman.

    好的。謝謝。讓我們把我們交給 Houman。

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Thank you for the question. Firstly, on [Ambly], when I was referring to longer interval earlier, I just for clarification for everyone on the call, we talked about which is a differentiated interval currently. And of (inaudible) and of course, an ongoing theme through our AD trial, starting with STREAM AD, which was a Q4W dosing and then into case 1 and case 2, et cetera. So point one is that when I was asked about what a [KLL], I would expect by then to Q4W dosing for an abundance of clarification.

    謝謝你的提問。首先,關於 [Ambly],當我之前提到更長的間隔時,我只是為了向電話會議中的每個人澄清一下,我們討論了當前哪個是差異化間隔。當然,(聽不清楚)也是我們 AD 試驗的持續主題,從 STREAM AD 開始,它是 Q4W 劑量,然後是案例 1 和案例 2,等等。所以第一點是,當我被問到什麼是 [KLL] 時,我期望到那時 Q4W 劑量能夠得到充分的澄清。

  • The second comment was your comment to Q12W and there are three data points that I would direct you to. Number one, is the cessation study of 3D, the off drug study component, as it was described. As you know, over 60% of patients had a maintenance on their response at 24 weeks, which is what the inspiration was to have both induction and maintenance Q2W dosing.

    第二條評論是您對 Q12W 的評論,我想向您指出三個數據點。第一,如所描述的,是 3D 的戒毒研究,即停藥研究部分。如您所知,超過 60% 的患者在 24 週時維持了治療反應,這就是誘導和維持 Q2W 給藥的靈感所在。

  • As you'll know from the core studies, nine studies in the [oceanos] program. We will see the rent threat of QW go through at least four of those studies, which include case 1 case 2 short and running into [history]. And the final part of that Emily question was, thank you for noting on the asthma study that the Q12W dosing in asthma was promising, and that adds to our understanding the OX40 ligand modulation of T cells in disease, does have the potential to have a longer interval traction.

    正如您從核心研究中所了解到的,[oceanos] 計劃中有九項研究。我們將看到 QW 的租金威脅經歷了至少四項研究,其中包括案例 1、案例 2、短期和運行[歷史]。Emily 問題的最後一部分是,感謝您在氣喘研究中指出 Q12W 劑量在氣喘治療中很有前景,這增加了我們對 OX40 配體調節疾病中 T 細胞的理解,確實有可能產生更長的間隔牽引力。

  • On SPMS and tolebrutinib, the only comment I'll make, and thank you for noting the importance of the REM. The only comment I'd make is it's a subject of active regulatory discussion and our practice is not to disclose any specific comments around it, especially this delicate stage of discussions with the regulator. So we found the collaborative interaction with the regulator extremely gratifying, and that's important.

    關於 SPMS 和托布替尼,這是我唯一要發表的評論,感謝您注意到 REM 的重要性。我唯一想說的是,這是一個正在積極監管討論的話題,我們的做法是不透露任何有關它的具體評論,尤其是在與監管機構討論的這個微妙階段。因此,我們發現與監管機構的合作互動非常令人滿意,這很重要。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you, Francois.

    謝謝你,弗朗索瓦。

  • François Roger - Executive Vice President, Chief Financial Officer

    François Roger - Executive Vice President, Chief Financial Officer

  • Yes, Sachin, on the increase of BI, you're absolutely right that what I said we will see our BOI increasing in absolute value in '26, '27 and in the following years as well. And you're right, I said in absolute value. that I'm very confident. That being said, I don't want to commit at this stage as a percentage of sales.

    是的,Sachin,關於 BI 的成長,你完全正確,我說過我們將看到我們的 BOI 在 26 年、27 年以及接下來的幾年裡絕對值會增加。你說得對,我說的是絕對值。我非常有信心。話雖如此,我並不想在這個階段以銷售額的百分比來承諾。

  • Don't forget this is what I mentioned in my presentation earlier, we had to absorb EUR1.1 billion of BOI that will not disappear, but that will go to a certain extent because of the end of the regenerant reimbursement of R&D.

    別忘了這就是我之前在演講中提到的,我們必須吸收 11 億歐元的 BOI,這筆錢不會消失,但由於研發再生補償的結束,這筆錢會在一定程度上減少。

  • So that's quite a significant amount. Even if we grow at a high rate and we will continue growing. I don't want to comment at this that we are working on it in order to try to make it valid as well as a percentage of sales, but I don't want to commit at this stage. Okay. Thank you.

    所以這是一個相當大的數字。即使我們以高速成長,我們也將繼續成長。我不想對此發表評論,我們正在努力使其有效並成為一定比例的銷售額,但我不想在此階段做出承諾。好的。謝謝。

  • Next question.

    下一個問題。

  • Operator

    Operator

  • Seamus Fernandez, Guggenheim.

    謝默斯·費爾南德斯,古根漢美術館。

  • Seamus Fernandez - Analyst

    Seamus Fernandez - Analyst

  • Great. Thanks so much for the questions. So just wanted to check in on patent estates and the patent portfolio. In terms of how you're thinking about the opportunity there? And then maybe just as an extension to that, life cycle management opportunities that you see on a go-forward basis with your partner, Regeneron.

    偉大的。非常感謝您的提問。所以只是想檢查一下專利資產和專利組合。您如何看待那裡的機會?然後,也許只是對此的延伸,您與合作夥伴 Regeneron 一起看到了生命週期管理機會。

  • And then just a quick second question. Houman, it seems like you're commenting on the orthogonal combination potential that might exist with are you really referring more to the potential to combine amlitelimab with other assets? Or are you talking about the prospect of whether it be Nanobody or other OX40 ligand combinations, in particular, in HS, at least, we know OX40 and the TNF will be presented, I believe, at ADB. Just trying to get a sense of your thoughts around how broadly the mechanism could be applied in various disease states. Thanks.

    然後是第二個簡短的問題。Houman,看起來您正在評論可能存在的正交組合潛力,您實際上是否更多地指的是將 amlitelimab 與其他資產相結合的潛力?或者您是在談論奈米抗體或其他 OX40 配體組合的前景,特別是在 HS 中,至少我們知道 OX40 和 TNF 將在 ADB 上展示。只是想了解一下您對該機制在各種疾病狀態下應用範圍有多廣泛的想法。謝謝。

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • I guess the question was about Dupixent. But in general, also for Dupixent. I remind you that the compound pattern expires in the year in March 31 in Europe, it expires in March '33 with all the exclusivities extensions attached to them. As Ben said, we've got 8 indications. We've been spending a huge amount of money on development.

    我猜問題是關於 Dupixent 的。但總的來說,Dupixent 也是如此。我提醒您,在歐洲,複合模式將於當年 3 月 31 日到期,其附帶的所有排他性延期也將於 33 年 3 月到期。正如本所說,我們有 8 個跡象。我們在開發上投入了大量的資金。

  • You can rest assure that we have ensured that we protected all innovations that the company prepared around the Dupixent. And we have a number of patterns going well beyond the composition of matter patent into the 40s and it's too early to speculate as and when we'll keep you updated on the relevant developments.

    您可以放心,我們已確保保護公司圍繞 Dupixent 所準備的所有創新。我們有許多模式遠遠超出了物質組成專利的範圍,進入了 40 年代,現在推測何時以及何時向您通報相關發展還為時過早。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you. Houman Ashrafian. If you can, LCM with our partner in general.

    謝謝。侯曼·阿什拉菲安。如果可以的話,LCM 與我們的合作夥伴大致相同。

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • The LTM in discussion with Regeneron active ongoing discussions with in the alliance, we work closely with them. We are excited by the ongoing relationship, which is active across the existing molecules like Dupi and itepekimab, but also potential new opportunities that we're seeing.

    LTM 正在與 Regeneron 進行積極的討論,並在聯盟內與他們密切合作。我們對正在進行的合作關係感到興奮,這種合作關係不僅活躍於 Dupi 和 itepekimab 等現有分子,也看到了潛在的新機會。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you, on Emily -- Combos.

    謝謝你,艾蜜莉——Combos。

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Well, firstly, let me just say on our dashboard at the moment, [Ambly mono] is very much in the headlines win screen and every other part of the front of the car. Our focus is 100% on executing on delivering those studies over the next year or so at large Oceana program.

    嗯,首先,我只想說,目前在我們的儀表板上,[Ambly mono] 在螢幕和汽車前部的其他每個部分中都佔據著頭條新聞。我們的重點是在未來一年左右在大型 Oceana 計畫中全面進行這些研究。

  • And in terms of -- so that is absolutely offer because in terms of combination therapies, OX40 ligand is an important biological node, licensing, Biology and far beyond the opportunity to do combination therapies as we've already demonstrated with a positive result in even (inaudible) in HS as you say, which is badly presented is going to open a whole new [vista].

    就聯合療法而言,OX40 配體是一個重要的生物節點,許可、生物學和遠遠超出聯合療法的機會,正如我們已經證明的那樣,即使在 HS 中也取得了積極成果,正如您所說,這種糟糕的呈現將開啟一個全新的[遠景]。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay. Thank you. Next question.

    好的。謝謝。下一個問題。

  • Operator

    Operator

  • Simon Baker, Redburn.

    西蒙貝克,雷德伯恩。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Thank you for taking my question. Two quick ones, if I may, please. Firstly, could you just give us an update on the current trends and your outlook of the Bay Fortis in the US. And then moving to Blueprint and BLU 808, the literature has been peppered with reports on Kit inhibition and inflammatory disease for second of 20 years. So I just wonder if you could give us your thoughts, Houman, the -- on why you see KIT inhibition in that setting as an interesting area and specifically what appeals to you about the Blueprint asset? Thanks so much.

    感謝您回答我的問題。如果可以的話,請簡單問兩個問題。首先,您能否向我們介紹一下當前的趨勢以及您對美國 Bay Fortis 的展望。然後轉向 Blueprint 和 BLU 808,20 年來,文獻中充斥著有關 Kit 抑制和發炎疾病的報告。所以我只是想知道您是否可以告訴我們您的想法,Houman,為什麼您認為該設置中的 KIT 抑制是一個有趣的領域,以及藍圖資產對您有何吸引力?非常感謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thomas, Beyfortus?

    托馬斯、貝福圖斯?

  • Thomas Triomphe - Executive Vice President, Vaccines

    Thomas Triomphe - Executive Vice President, Vaccines

  • So Beyfortus, as discussed before, we see some growth for Beyfortus overall in 2025. This will come from market expansion as Beyfortus is going to more and more geographies. You know very well, but there is further competition entering into the field. I just want to take the opportunity while the new product is also more antibody, both market entities are very different, extremely very different half-life, before as a flag of 71 days.

    因此,正如先前所討論的,Beyfortus 預計在 2025 年將實現整體成長。隨著 Beyfortus 進入越來越多的地區,這將透過市場擴張實現。您很清楚,但是進入該領域的競爭還在加劇。我只是想趁著這個機會,新產品也多抗體,兩個市場實體差異很大,半衰期極為不同,之前作為flag的有71天。

  • The other product as [life] 42 days and very, very different world experience with votes being studies -- with outstanding results. Due to that, we expect that overall US this year will keep increasing this year and next year, take three years to five years [probably] intervention for vaccination commentaries to reach their peak. So overall, [RAV] for the prevention will increase, and Beyfortus will remain the dominant player, thanks to its that asset.

    另一項產品是《生命》42 天,以及非常非常不同的世界體驗,透過投票進行研究——並取得了出色的成果。因此,我們預計今年美國整體疫苗接種率將繼續上升,明年可能需要三到五年的時間才能達到高峰。因此總體而言,預防方面的 [RAV] 將會增加,而 Beyfortus 憑藉這一優勢仍將佔據主導地位。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Briefly, Houman on (inaudible)

    簡而言之,Houman(聽不清楚)

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Yes, Simon, I guess you can never take the chemist out of you when you speak. We're Firstly, let's start by saying we are honored and privileged to have the Blueprint team join us. They really are the experts in biology and our industry is characterized by experts being able to achieve outstanding results. speaking very briefly about Marcell biology as you know, based on your background specifically, targeting wild-type KT has been sort of (inaudible) the industry for decades.

    是的,西蒙,我想當你說話的時候,你永遠無法擺脫化學家的氣質。首先,我們很榮幸能夠邀請 Blueprint 團隊加入我們。他們確實是生物學專家,而我們行業的特點是專家能夠取得傑出的成果。非常簡要地談談 Marcell 生物學,正如您所知,具體根據您的背景,針對野生型 KT 已經成為(聽不清楚)該行業幾十年來的主要研究方向。

  • You know very well from the time of [William Osler], Marcell and their rolling inflammation diseases, place diseases, such (inaudible) as far beyond have been important if we can target wild-type you get with an adequate therapeutic index, then it will open up a whole number of [examines].

    您很清楚,從 [William Osler] 時代開始,Marcell 和他們的滾動發炎疾病、位置疾病,這些(聽不清楚)遠遠超出了重要的範圍,如果我們能夠針對野生型,並具有足夠的治療指數,那麼它將開闢大量的[檢查]。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Yeah. I think I think ultimately, it's a nice shot to have in the pipeline. It's been around a long time if we get it right. It could be great. And if it doesn't, then it's early enough for us to make a tough call, but we're optimistic. Let's see Okay, this question. Okay. Next question.

    是的。我認為,從根本上來說,這是一個不錯的嘗試。如果我們做對了,它已經存在很久了。這可能會很棒。如果沒有,那麼我們現在做出艱難的決定還為時過早,但我們仍然保持樂觀。我們來看看這個問題。好的。下一個問題。

  • Operator

    Operator

  • Sarita Kapila, Morgan Stanley.

    薩里塔·卡皮拉,摩根士丹利。

  • Sarita Kapila - Analyst

    Sarita Kapila - Analyst

  • Thanks for taking my question. Sorry to come back to margins, but maybe should we think about 26 margins being flat as a floor -- and you provided more color on refunding income and our future royalties, but should we expect divestment income. I believe it's EUR500 million this year to continue into ['26] and 2027?

    感謝您回答我的問題。很抱歉再次回到利潤率問題,但也許我們應該將 26 個利潤率視為一個底線 - 並且您提供了有關退款收入和我們未來特許權使用費的更多細節,但我們是否應該預期撤資收入。我相信今年的收入將達到 5 億歐元,並持續到 ['26] 和 2027 年?

  • And then just a quick one on Blueprint and Ayvakit competition from Cogen's (inaudible). Maybe you could have some words on the molecule given the [livotox]. I'm sure you diligenced the landscape, but do you believe Blueprint adequately factored competition in the EUR2 billion peak sales guide? Thank you.

    然後簡單介紹一下 Blueprint 和 Ayvakit 的競爭,Cogen 的(聽不清楚)。也許你可以對分子做一些描述,因為[利沃托克斯]。我相信您已經仔細研究了形勢,但您是否相信藍圖在 20 億歐元高峰銷售指南中充分考慮了競爭因素?謝謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you. Francois?

    謝謝。弗朗索瓦?

  • François Roger - Executive Vice President, Chief Financial Officer

    François Roger - Executive Vice President, Chief Financial Officer

  • It's on the '26, I don't want to guide for '26. It's too early to do that. And so we'll do that in due time. But once again, I confirm the fact that we are working towards an increase in BOI next year that will start with the benefit of growth leverage and the strong growth on the top line again.

    這是在 26 日,我不想為 26 日做指導。現在這麼做還為時過早。因此我們會在適當的時候這樣做。但我再次確認,我們正在努力實現明年 BOI 的成長,這將從成長槓桿的好處和營業額的強勁成長開始。

  • I do confirm what you said, which is we do expect to get probably EUR0.5 billion not potentially more, by the way, from disposal in terms of capital gains from the disposal at we regularly had about EUR0.5 billion, might be a little bit more in the future, but at least that amount.

    我確實確認了你所說的,我們確實希望從處置中獲得大約 5 億歐元,順便說一下,從處置中獲得的資本收益可能不會更多,我們通常有大約 5 億歐元,將來可能會多一點,但至少是這個數額。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay. I (inaudible) to Brian competitiveness of Ayvakit.

    好的。我(聽不清楚)向 Brian 介紹了 Ayvakit 的競爭力。

  • Brian Foard - Executive Vice President, Head of Specialty Care

    Brian Foard - Executive Vice President, Head of Specialty Care

  • Yeah, I think it's a fantastic question. And I'll start kind of the same way we talk about a lot of the disease states across immunology, which is, first and foremost, this is a very underpenetrated marketplace. They've just launched into the space. And if you look at the growth for Avid is because they are finding new patients, getting new patients on therapy, keeping new patients on therapy. So as we've said before, new competition into any space like that is actually good for the space from a noise level standpoint, finding these patients.

    是的,我認為這是一個非常好的問題。我將以我們討論免疫學領域的許多疾病狀態的相同方式開始,首先,這是一個滲透率很低的市場。他們剛剛進入太空。如果你看一下 Avid 的成長,那是因為他們正在尋找新患者、讓新患者接受治療、讓新患者繼續接受治療。因此,正如我們之前所說的那樣,從噪音水平的角度來看,任何領域的新競爭實際上對找到這些患者都有好處。

  • It's a really symptomatic disease state that presents itself in a lot of really important specialists that we call on a regular basis today, and we'll continue to call on in the future. That said, I think that they have done a very nice job of factoring future competition into the mix, not only for market growth but also for leadership share. So we feel very confident with Ayvakit and its profile, especially in recent light of the readout that we just saw from [bazoo].

    這是一種非常有症狀的疾病狀態,出現在我們今天定期拜訪的許多非常重要的專家身上,我們將來還會繼續拜訪他們。話雖如此,我認為他們在考慮未來競爭方面做得非常好,不僅是為了市場成長,也是為了領導地位的份額。因此,我們對 Ayvakit 及其產品形象非常有信心,尤其是考慮到我們剛剛看到的[鼻孔]。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Alright. Thank you. Next question.

    好吧。謝謝。下一個問題。

  • Operator

    Operator

  • Peter Verdult, BNP.

    英國國家黨的彼得·維爾杜爾特(Peter Verdult)。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Thanks. Just a couple for Paul. Number one, interest in gaming and enthusiasm around IL-17 becoming part of your pipeline portfolio in line with the growing opportunity in NS (inaudible) and data this week, we're showing very promising efficacy in atopic dermatitis.

    謝謝。僅對保羅而言。首先,對遊戲的興趣和對 IL-17 的熱情成為您的管道組合的一部分,這與 NS 不斷增長的機會(聽不清楚)和本週的數據一致,我們顯示出對異位性皮膚炎非常有希望的療效。

  • And then second, of course, sorry about the obligatory question on US pricing or full and the potential for Europe to step up and share the load just (inaudible). Third, if I could squeeze one in for Houman. Just when should we expect to hear about next steps and plans on your go-forward strategy I want to pick a member whether it will get terminated? Is that something that we should expect to hear about this year? Or are you still doing work?

    其次,當然,很抱歉我問了一個關於美國定價或全價的問題,以及歐洲是否有可能加緊分擔負擔(聽不清楚)。第三,如果我能為 Houman 擠出一個時間的話。我們什麼時候才能聽到關於您前進策略的下一步行動和計劃?我想挑選一名成員,他是否會被終止?我們今年應該會聽到這樣的消息嗎?還是你還在工作嗎?

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay, Peter, thanks very much. I'm not sure what the question was on IL17. Was it -- is it -- I can't meet that. So you have to tell me what was the question? It was in AD? Okay. I'm not sorry. Let's go to another question -- another part of the question. Houman, maybe it's a pet and then I'll answer pricing. And then we'll come back to that question.

    好的,彼得,非常感謝。我不確定 IL17 上的問題是什麼。是嗎?是嗎?我無法滿足這個要求。那你必須告訴我問題是什麼?是在西元嗎?好的。我並不感到抱歉。讓我們討論另一個問題——問題的另一部分。Houman,也許它是一隻寵物,然後我會回答定價。然後我們再回到這個問題。

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Okay. Itepekimab, we were obviously hoping for better results than our mixed result. We're working closely across the alliance with Regeneron, working through the basis for the difference in 5102. And once we figure that out, we have to recognize that two felt we will go back to the regulator for next step.

    好的。Itepekimab,我們顯然希望獲得比混合結果更好的結果。我們正在與 Regeneron 緊密合作,努力解決 5102 差異的基礎。一旦我們弄清楚了這一點,我們就必須認識到,我們將回到監管機構採取下一步行動。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay. So then Peter, maybe it was just us here, but you really broke up on the first part. I think the question was about IL-17 for sure, the UCB, I think, had some early data. I think that's what we've coupled together here. Look, we believe the assets we have in AD will be the difference.

    好的。那麼彼得,也許只有我們這裡才有這種感覺,但你們在第一部分確實分手了。我認為問題肯定與 IL-17 有關,我認為 UCB 有一些早期數據。我認為這就是我們在這裡結合在一起的東西。瞧,我們相信我們在 AD 中擁有的資產將會帶來不同。

  • There's no surprises there. We'll get close one, see how that looks, decide how competitive it is. I think in immunology, there's always an opportunity to show an impact whether you can really make a difference. We will see I'm very familiar with IL-17, but I think our emphasis has been on breakthrough technologies and opportunities and intervals to try and really improve the patient outcome.

    沒有什麼令人驚訝的。我們會接近它,看看它看起來如何,然後判斷它的競爭力。我認為在免疫學領域,總有機會展示你是否真的能有所作為。我們會看到我對 IL-17 非常熟悉,但我認為我們的重點一直放在突破性技術、機會和間隔上,以嘗試真正改善患者的治療結果。

  • US pricing, I think you said at the second part of it, the relationship between Europe and the US But just very quickly, we don't know the final voting from the White House on how we love between the 232 investigation, MFN and tariffs.

    美國定價,我想你在第二部分提到了歐洲和美國之間的關係,但很快,我們不知道白宮對232調查、最惠國待遇和關稅的最終投票結果。

  • And tariffs once they are established, and we know them important step. Then we'll know what the relationship is like the other two components and know whether it's a 15% tariff with a caveat or 15-plus or 15 less. We don't know. And nobody knows. But we prepared for delivering the guidance this year.

    一旦確定了關稅,我們就知道這是重要的一步。然後我們就會知道它與其他兩個組成部分的關係,並知道它是帶有警告的 15% 關稅,還是 15% 以上或 15% 以下。我們不知道。沒人知道。但我們已做好了今年提供指導的準備。

  • That's a minimum. So don't feel we're casual about it because we're absolutely not. I've been on record as many CEOs now about innovation access in Europe. And there's part of me as a parent and as a member of society would still concern that more than 50% of medicines approved in Europe are not available to patients in Europe.

    這是最低限度。所以不要覺得我們對此很隨意,因為我們絕對不是。我和許多執行長一樣,都曾公開談論過歐洲的創新管道。作為家長和社會成員,我仍然擔心歐洲批准的 50% 以上的藥物無法提供給歐洲患者。

  • I think the value of a medicine should be paid for. And I think there's a lot of people who could contribute to economies in GDP of medicines were made available to them. I'm as interested in budgets for health care, giving access to innovation for more patients as they are in the pricing conversation. We will see when net when we have the facts, we will share them. But we're a health care company would like to see more patients can access Excuse me a patient can access to more innovation. Next question.

    我認為藥品的價值是應該支付的。我認為,透過向人們提供藥品,許多人都可以為 GDP 經濟做出貢獻。我對醫療保健預算很感興趣,希望讓更多的病人能夠享受創新,就像他們對定價的討論一樣。當我們掌握事實時,我們就會與大家分享。但我們是一家醫療保健公司,希望看到更多的患者能獲得更多創新。下一個問題。

  • Operator

    Operator

  • David Risinger, Leerink. David?

    David Risinger,Leerink。戴維?

  • David Risinger - Analyst

    David Risinger - Analyst

  • Yes. So I just have one question, please, please. Could you discuss your expectations for tolebrutinib in PPMS. Houman, if you could just comment on efficacy expectations and also what you're anticipating from the liver toxicity data in that trial. Thanks very much.

    是的。所以我只有一個問題,請問一下。您能否討論一下您對托布替尼在 PPMS 中的期望。Houman,您能否評論一下療效預期以及您對該試驗中肝毒性數據的預期。非常感謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Thank you. Houman?

    謝謝。豪曼?

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Yes. So thanks for the question, succinctly, there's a significant biological overlap between DMS and PPMS. There was a major paper around genetics, it's a progressive disease, a couple of years ago from Australia. Our view is there is at least some biological reason to believe that small ring inflammation and brain compartment inflammation are important in both diseases, and there may be some read through. We look forward to seeing those results later in the year. And with respect to toxicity profile of the liver, we expect it to be commensurate with what we see in SPMS.

    是的。感謝您的提問,簡而言之,DMS 和 PPMS 之間存在顯著的生物學重疊。幾年前,澳洲發表了一篇關於遺傳學的重要論文,稱這是一種進行性疾病。我們的觀點是,至少有一些生物學原因讓我們相信小環發炎和腦區發炎在兩種疾病中都很重要,並且可能有一些解讀。我們期待在今年稍後看到這些結果。就肝臟毒性特徵而言,我們預計它與我們在 SPMS 中看到的一致。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay. I think maybe we have time for one more.

    好的。我想我們也許還有時間再做一次。

  • Operator

    Operator

  • Ben Jackson, Jefferies.

    本·傑克遜,傑富瑞。

  • Benjamin Jackson - Analyst

    Benjamin Jackson - Analyst

  • Great. Thanks for the questions. Just one final one for me then on a [Lirilumab]. we think about the efficacy that we've been talking about in several questions here, what is it specifically that you've seen physicians and patients are looking for in terms of which end point.

    偉大的。感謝您的提問。那麼,關於 [Lirilumab],我最後再問一個問題。讓我們思考一下我們在這裡的幾個問題中討論過的療效,您看到醫生和患者在哪個終點方面具體尋求什麼。

  • We've obviously had a lot of noise recently about perhaps how each benefit is helping to drive penetration to the market. And clearly, within your Phase III designs, you have built in some itch endpoints into that. So I guess, which of the endpoints we should be paying most attention to? And then secondly, is there any reason to believe that the OX40 mechanism could perhaps have a beneficial effect on itch. Thank you.

    顯然,我們最近聽到了很多關於每項福利如何幫助推動市場滲透的討論。顯然,在您的第三階段設計中,您已經將一些關鍵終點融入其中。所以我猜,我們應該最關注哪一個端點?其次,是否有理由相信 OX40 機制可能對搔癢產生有益作用。謝謝。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Houman?

    豪曼?

  • Houman Ashrafian - Executive Vice President, Head of Research and Development

    Houman Ashrafian - Executive Vice President, Head of Research and Development

  • Yes. So again, briefly, I think that -- your second question first, the OX40 ligand biology, had already worked out, specifically the ligand is likely through its effect on T cells and neuroinflammatory access have an effect solely on the atopic tenements and possibly etch there's a literature on that.

    是的。所以,再次簡要地說,我認為——首先你的第二個問題,OX40 配體生物學已經得到解決,具體來說,該配體很可能通過其對 T 細胞和神經炎症通路的影響,僅對特應性特徵產生影響,並且可能有這方面的文獻。

  • Happy to us off-line. And with respect to the endpoints, I think the key here, both regulatory and from a community perspective [IJ01] and [EAZ75] at obviously, the things that the entry ticket in a disorder which has significant low biopenrate I think that those would be the entry ticket for what we do.

    很高興我們下線了。關於終點,我認為這裡的關鍵,無論是從監管角度還是從社區角度來看 [IJ01] 和 [EAZ75],顯然,對於生物開放率明顯較低的疾病,入門券就是我們要做的。

  • Paul Hudson - Chief Executive Officer

    Paul Hudson - Chief Executive Officer

  • Okay, Ben. Thanks. The last question. We delivered strong performance in Q2 with 10.1% sales growth refined our 2025 sales guidance. At the same time, we confirm our guidance strong business EPS rebound. Our pipe Bank continued to make progress despite the mixed results for itepekimab in COPD, and we eagerly anticipate several important Phase III data readouts in the second half of the year, including amlitelimab tolebrutinib. Augmenting our own pipeline because the acquisition of Blueprint Rare Diseases, we'll remain focused on strategically redeploying capital towards pipeline and growth as we continue to advance our strategy.

    好的,本。謝謝。最後一個問題。我們在第二季表現強勁,銷售額成長 10.1%,完善了 2025 年的銷售預期。同時,我們確認我們的指導是強勁的業務每股收益反彈。儘管 itepekimab 在 COPD 治療中的結果好壞參半,但我們的管道庫仍在繼續取得進展,我們熱切期待下半年幾個重要的 III 期數據讀數,包括 amlitelimab tolebrutinib。由於收購了 Blueprint Rare Diseases,我們擴大了自己的產品線,我們將繼續專注於策略性地重新部署資本用於產品線和成長,並繼續推動我們的策略。

  • With this I wish everyone a good summer. We'll close the call.

    我祝福大家有個愉快的夏天。我們將結束通話。