Sanofi SA (SNY) 2024 Q3 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 Q3 2024 conference call for investor 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 statement.

    大家好,我是賽諾菲 IR 團隊的 Thomas Kudsk Larsen。歡迎參加 2024 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。請翻到第 3 張投影片。這裡我們有通常的前瞻性聲明。

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

    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,可能導致實際結果有重大差異。我們鼓勵您閱讀我們幻燈片簡報中的免責聲明。此外,我們建議您參閱美國證券交易委員會 (USA SEC) 備案的 20-F 表格,以了解這些風險因素的描述。

  • As usual, we'll be making comments on our performance using constant exchange rates and other non-IFRS measures. Numbers used are in million euro and for Q3, 2024 unless stated otherwise. Please turn to slide number 4.

    像往常一樣,我們將使用恆定匯率和其他非國際財務報告準則衡量標準對我們的業績進行評論。除非另有說明,所使用的數字以百萬歐元為單位,適用於 2024 年第三季。請翻到第 4 張投影片。

  • First, we have a presentation, then we'll take your questions. As last time we kept the presentation on the shorter side to allow for more questions and we end up keeping the call to about one hour.

    首先,我們進行演示,然後回答您的問題。與上次一樣,我們將演示時間縮短,以便提出更多問題,最終將通話時間控制在一個小時左右。

  • For Q&A, we have Brian, Olivier, Thomas, and Julie to cover the global business and Roy, our General Counsel. For the Q&A you have two options in zoom. Raise your hand or submit your question using the Q&A function.

    對於問答環節,我們有 Brian、Olivier、Thomas 和 Julie 負責全球業務,Roy 是我們的總法律顧問。對於問答,您有兩種縮放選項。舉手或使用問答功能提交問題。

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

    有了這個,我現在就把你交給保羅。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Thomas. Nicely done. Thank you, and hello, everyone on the call. We reaffirm strong sales performance this year. The total of Q3 sales of EUR13.4 billion, a 16% increase in CER an estimated 11% excluding the impact of phasing.

    謝謝你,托馬斯。幹得好。謝謝大家,大家好。我們重申今年強勁的銷售業績。第三季銷售額總額為 134 億歐元,以固定匯率計算成長 16%,排除分階段影響預期成長 11%。

  • This robust double-digit growth illustrates the underlying strength of our portfolio. Dupixent continue to be driven by global volume growth across all indications and geographies, now reaching close to EUR3.5 billion in the quarter.

    這種強勁的兩位數成長說明了我們投資組合的潛在實力。Dupixent 繼續受到所有適應症和地區的全球銷售成長的推動,本季目前已接近 35 億歐元。

  • Our vaccines business grew 26%, this increase benefited from an element of phasing in flu and bake order sales. However, the global rollout of Bayport has provided a strong contribution as well. Our pharma launches have been performing very well with a 67% increase in sales. This is a result of strong performance across all eight medicines that we have recently launched and a clear illustration of the value those medicines bring to healthcare systems and patients.

    我們的疫苗業務成長了 26%,這一成長得益於分階段流感和烘焙訂單銷售。然而,Bayport 的全球推出也做出了巨大貢獻。我們的藥品上市表現非常出色,銷售額成長了 67%。這是我們最近推出的所有八種藥物表現強勁的結果,也清楚地說明了這些藥物為醫療保健系統和患者帶來的價值。

  • Opella's 8% growth was predominantly driven by the strategic acquisition of Kunal in the US, which has bolstered our presence in the consumer healthcare market.

    Opella 8% 的成長主要得益於對美國 Kunal 的策略性收購,這增強了我們在消費者醫療保健市場的地位。

  • That is why with confidence that we have once again raised our business EPS guidance for 2024 on Monday. This reflects our continued momentum and our commitment to delivering value to our stakeholders.

    這就是為什麼我們週一再次滿懷信心地提高了 2024 年的業務每股收益指引。這反映了我們持續的動力以及我們為利害關係人提供價值的承諾。

  • On slide 6, Dupixent delivered another quarter of strong growth. It also reached a major milestone of improving the lives of more than 1 million patients currently on treatment around the world across approved indications, age groups and geographies.

    在投影片 6 上,Dupixent 又實現了一個季度的強勁成長。它還達到了一個重要的里程碑,改善了世界各地目前正在接受治療的超過 100 萬名患者的生活,這些患者跨越已批准的適應症、年齡組和地理。

  • Dupixent continues to hold the number one new-to-brand prescription market share across all its approved indications in the US. Outside the US, Dupixent is now approaching blockbuster status in a single quarter. This remarkable performance reinforces our confidence and our sales ambition of around EUR13 billion for the full year 2024.

    Dupixent 在美國所有批准的適應症中繼續保持第一的新品牌處方藥市場份額。在美國以外的地區,Dupixent 現在在一個季度內就達到了重磅炸彈的地位。這項卓越的業績增強了我們的信心以及 2024 年全年約 130 億歐元的銷售目標。

  • The recent consecutive approvals of the COPD indication in the US and China on the heels of the EU approval four months ago speaks volumes of our ability to move decisively execute and meet the need for more treatment options. The expansion of Dupixent COPD will give hundreds of thousands of additional patients who are living with this devastating disease, the chance to potentially improve breathing and a life with fewer exacerbations.

    在歐盟四個月前批准慢阻肺適應症後,美國和中國最近連續批准了慢阻肺適應症,這充分說明了我們果斷行動和滿足更多治療選擇需求的能力。Dupixent COPD 的擴展將為數十萬患有這種毀滅性疾病的患者提供潛在改善呼吸的機會,並減少病情惡化的生活。

  • Additional positive Phase 3 readouts in Bullous pemphigoid and chronic spontaneous urticaria will also if approved, create additional near term growth opportunities.

    如果獲得批准,大皰性類天皰瘡和慢性自發性蕁麻疹的其他第 3 期陽性結果也將創造更多的近期成長機會。

  • Turning to slide 7, we will continue to execute on the three commercial levels that will propel Dupixent's volume demand and its growth longer term. First, the steady increase in the penetration of advanced therapies within the biologic eligible patient population. New market entrants of other biologics are expected to help drive market growth through improved awareness and adoption.

    轉向幻燈片 7,我們將繼續在三個商業級別上執行,這將推動 Dupixent 的銷售需求及其長期成長。首先,先進療法在符合生物學條件的患者群體中的滲透率穩步提高。其他生物製品的新市場進入者預計將透過提高認知度和採用率來幫助推動市場成長。

  • Second, the geographic expansion with around 30 potential country launches across existing indications by 2026. Third, the expansion into new indications with high unmet need for large biologic eligible patient populations like COPD and CSU.

    其次,到 2026 年,將針對現有適應症啟動約 30 個潛在國家的地理擴張。第三,拓展新的適應症,這些適應症對大量符合生物標準的患者群體(例如慢性阻塞性肺病(COPD)和慢性阻塞性肺病(CSU))的需求未得到滿足。

  • Specifically in the US market, we continue to strengthen patient access to support new indication expansion, including COPD and other new indications and expand access across both commercial and government channels. We remain excited by the opportunities ahead of us and in the strong growth outlook for Dupixent for which we continue to target a low double-digit sales increase at CAGR between 2023 and 2030 at constant exchange rate.

    特別是在美國市場,我們繼續加強患者准入,以支持新適應症的擴展,包括慢性阻塞性肺病和其他新適應症,並擴大商業和政府管道的准入。我們對眼前的機會和 Dupixent 的強勁成長前景仍然感到興奮,我們繼續將 2023 年至 2030 年按固定匯率計算的複合年增長率實現兩位數的低兩位數銷售額增長目標。

  • Now on slide 8, our strong growth in the quarter was accelerated by the outstanding performance of our newly launched medicines. With almost EUR3 billion in the first nine months, our launches have become significant contributors to Sanofi's accelerated topline growth profile. [Before] this leads the way with sales of EUR645 million in Q3, showing an exceptional market uptake in its second season and underscoring the critical role it plays in all infant protection.

    現在在投影片 8 上,我們新推出的藥品的出色表現加速了我們本季的強勁成長。我們的產品在前 9 個月就銷售額近 30 億歐元,已成為賽諾菲營收加速成長的重要貢獻者。 [之前]該產品在第三季度以 6.45 億歐元的銷售額領先,顯示出第二季度的出色市場吸收率,並強調了它在所有嬰兒保護中發揮的關鍵作用。

  • With sales of EUR172 million, ALTUVIIIO further established its position as the new high efficacy standard of care in hemophilia treatment demonstrated by patient switches from other factor and non-factor medicines. Other innovative medicines like Nexviazyme, Rezurock, Sarclisa continue to perform well. And are contributing to a total of EUR1.4 billion in sales for this quarter alone.

    ALTUVIIIO 的銷售額達到 1.72 億歐元,進一步確立了其作為血友病治療新高效護理標準的地位,這一點透過患者從其他因素和非因素藥物的轉變得到了證明。其他創新藥物如 Nexviazyme、Rezurock、Sarclisa 繼續表現良好。光是本季就貢獻了 14 億歐元的銷售額。

  • These results show the power of our launch engine and how with the right focus and sharp execution, we are increasingly delivering transformative treatments to patients around the world.

    這些結果展示了我們啟動引擎的力量,以及我們如何透過正確的重點和敏銳的執行力,越來越多地為世界各地的患者提供變革性的治療。

  • Moving to slide 9, our leading respiratory vaccines bay fortis and Fluzone High-Dose have established new standards of efficacy. Beginning with Beyfortus on the left side, we continue to build an outstanding body of evidence to further strengthen our position as market leader in all infant protection.

    轉到幻燈片 9,我們領先的呼吸道疫苗 bay fortis 和 Fluzone High-Dose 建立了新的功效標準。從左側的 Beyfortus 開始,我們繼續建立出色的證據體系,以進一步鞏固我們作為所有嬰兒保護市場領導者的地位。

  • A recent study demonstrates that Beyfortus continues to protect infants against RSV hospitalization over a full six month duration without waning efficacy. Furthermore, in the US, real world evidence showed an 87% efficacy and reduction of hospitalization rates. This reinforces the real world effectiveness that Beyfortus has consistently shown with more than an 80% hospitalization reduction in over 75,000 infants.

    最近的一項研究表明,Beyfortus 在整整六個月的時間內持續保護嬰兒免受 RSV 住院治療,且療效不減弱。此外,在美國,現實世界的證據顯示有效率達 87%,住院率降低。這強化了 Beyfortus 在現實世界中一貫表現出的有效性,使超過 75,000 名嬰兒的住院率減少了 80% 以上。

  • Importantly, we've been able to secure supply to extend protection against RSV to millions of infants in about 20 countries where Beyfortus is currently launched. To summarize, we're on our way to making Beyfortus our next blockbuster thanks to its unique ability to provide all infant protection.

    重要的是,我們已經能夠確保供應,將 RSV 保護範圍擴大到目前推出 Beyfortus 的約 20 個國家的數百萬個嬰兒。總而言之,我們正在努力使 Beyfortus 成為我們的下一個重磅產品,因為它具有提供所有嬰兒保護的獨特能力。

  • Transitioning to influenza, we are glad to see that regulators have increased their focus on the quality of studies supporting the efficacy of flu vaccines by requiring large scale randomized controlled trials against standard dose.

    轉向流感,我們很高興看到監管機構透過要求針對標準劑量進行大規模隨機對照試驗,更加關注支持流感疫苗功效的研究品質。

  • As a reminder, this is what we've done for Fluzone High-Dose. The only vaccine that has demonstrated statistically superiority to standard dose with a 24% superior efficacy in a randomized controlled trial with 32,000 participants. In contrast, the adjuvanted and mRNA flu vaccines of other companies still must pass that high bar with their ongoing studies.

    提醒一下,這就是我們為高劑量 Fluzone 所做的事情。這是唯一一種在統計上優於標準劑量的疫苗,在一項有 32,000 名參與者參加的隨機對照試驗中,療效高出 24%。相較之下,其他公司的佐劑和 mRNA 流感疫苗仍然必須透過他們正在進行的研究來通過這個高標準。

  • On my last slide, let me conclude with how we advance our ESG commitments in and beyond the workplace. As a responsible employer across the world, we're committed to ensuring a living wage for all our employees. This is why we've adopted the recognized standard of the fair wage network, which guarantees wages above local benchmarks.

    在最後一張投影片中,我將總結我們如何在工作場所內外推進我們的 ESG 承諾。作為全球負責任的雇主,我們致力於確保所有員工的生活工資。這就是為什麼我們採用公認的公平工資網路標準,保證薪資高於當地基準。

  • And going beyond our workforce, our commitment extends to our key supply chain partners by taking direct responsibility for our employees and partners, we are improving employee wellbeing and strengthening local economies. As always, when it comes to our commitment to society and our industry leadership, we hope that others will follow and help set new standards.

    除了我們的員工隊伍之外,我們的承諾還延伸到我們的主要供應鏈合作夥伴,透過對我們的員工和合作夥伴直接負責,我們正在改善員工福祉並加強當地經濟。一如既往,當談到我們對社會的承諾和行業領導地位時,我們希望其他人能夠遵循並幫助制定新標準。

  • With that, I now hand over to Francois, our CFO.

    現在,我將工作交給我們的財務長弗朗索瓦 (Francois)。

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • Thank you, Paul. Good morning and good afternoon to all. Before I start, let me clarify that financials for these quarters include Opella operations. Now let me discuss our strong sales momentum. Our topline growth was strong at 15.7% in Q3 at constant exchange rates with sales reaching EUR13.4 billion.

    謝謝你,保羅。大家早安,下午好。在開始之前,讓我澄清一下,這些季度的財務數據包括 Opella 業務。現在讓我談談我們強勁的銷售動能。以固定匯率計算,我們第三季的營收成長強勁,達到 15.7%,銷售額達到 134 億歐元。

  • This performance was partially supported by the early shipments in the flu season and Beyfortus strong momentum. Excluding this phasing benefit, we still achieved an underlying double-digit growth estimated to be around 11% similar to what we achieved in Q2.

    這一業績在一定程度上得益於流感季節的早期發貨和 Beyfortus 的強勁勢頭。排除這一階段性效益,我們仍然實現了潛在的兩位數成長,估計約為 11%,與第二季的情況類似。

  • Our solid growth in Q3 was broad based across businesses and geographies. The strategic decisions we have made across our business units are delivering attractive results and give us confidence to continue delivering strong performance in the coming quarters.

    我們在第三季的穩健成長在各個業務和地區都有廣泛的基礎。我們在各個業務部門做出的策略決策正在帶來有吸引力的結果,並使我們有信心在未來幾季繼續實現強勁的業績。

  • Now, moving to the Group P&L. Gross margin improved by a full percentage point in the quarter driven by a positive mix effect, partly offset by currency impacts on the Aubagio loss of exclusivity. Higher R&D expenses are aligned with a committed increase for 2024 reflecting our continued investment in innovation. SG&A grew substantially less than sounds underscoring our focus on operational efficiency.

    現在,轉向集團損益表。在積極的混合效應的推動下,本季毛利率提高了整整一個百分點,但 Aubagio 失去獨家經營權的貨幣影響部分抵消了這一影響。更高的研發費用與 2024 年承諾的成長保持一致,反映出我們對創新的持續投資。SG&A 的成長遠低於聽起來,突顯了我們對營運效率的關注。

  • Business operating income saw a significant increase of 19.9% in the quarter, primarily driven by higher gross profit and operating leverage. Our business EPS increased by 17.6% in Q3. Previewing our business outlook for Q4, we expect continued solid year-on-year growth, although at a lower level than in Q3. Do remember that there is one less invoicincg than in the US in Q4 versus Q3.

    本季業務營運收入大幅成長 19.9%,主要是由於毛利和營運槓桿較高。第三季我們的業務 EPS 成長了 17.6%。展望第四季的業務前景,我們預計將繼續保持穩健的同比成長,儘管水準低於第三季。請記住,與第三季相比,第四季的發票數量比美國少。

  • Beyfortus Q4 sales are projected to be in line with the Q3 level, supported by the approved additional industrial capacity. We expect Beyfortus sales to reach around EUR1.5 billion in 2024, a remarkable performance in its first full year of marketing. For Q4, please remember that we had around EUR400 million of one-off COVID revenues in Q4 2023 as well as the associated margin.

    在核准的新增工業產能的支持下,Beyfortus 第四季的銷售額預計將與第三季的水準保持一致。我們預計 Beyfortus 的銷售額將在 2024 年達到 15 億歐元左右,這在其第一個全年行銷中表現出色。對於第四季度,請記住,我們在 2023 年第四季度的一次性新冠疫情收入以及相關利潤約為 4 億歐元。

  • We confirm our full year guidance to increase R&D costs by around EUR700 million this year. And we will also marginally increase our investment in sales and marketing to support sales growth with a specific focus on digital investments. For the full year 2024, we expect flu sales to decline by a low-single digit percentage due to a soft vaccination rate while we continue to gain market share. The total vaccines franchise is now expected to grow by a high single-digit percentage.

    我們確認今年全年研發成本增加約 7 億歐元。我們也將小幅增加對銷售和行銷的投資,以支持銷售成長,特別關注數位投資。2024 年全年,由於疫苗接種率疲軟,我們預計流感銷售額將出現低個位數百分比下降,同時我們將繼續獲得市場份額。目前預計疫苗特許經營總額將以高個位數百分比成長。

  • Our insulin franchise, more specifically, Lantus is very resilient and cells are stabilizing. We expect divestments to reduce sales by about EUR300 million in 2024. And we anticipate capital gains from divestments to be around EUR400 million in biopharma only.

    我們的胰島素專營權,更具體地說,來得時非常有彈性,細胞也很穩定。我們預計 2024 年撤資將使銷售額減少約 3 億歐元。我們預計僅在生物製藥領域的資產剝離帶來的資本收益約為 4 億歐元。

  • Gross margin is expected to decline slightly in Q4 and for the full year due to one-offs last year such as COVID revenues and Aubagio sales. As disclosed earlier this week, we upgraded our guidance with 2024 business EPS expected now to grow by at least a low-single-digit percentage at constant exchange rates from previously around flat. This reflects a strong business performance over the last two quarters and this reflects our confidence in our view.

    由於去年的一次性收入(例如新冠肺炎收入和 Aubagio 銷售),預計第四季度和全年的毛利率將略有下降。正如本週稍早披露的那樣,我們上調了預期,預計 2024 年企業每股收益按固定匯率計算將至少實現低個位數百分比增長,而此前則持平。這反映了過去兩季強勁的業務表現,也反映了我們對自己觀點的信心。

  • Turning now to Opella. This transaction marks an important strategic step for Sanofi to become a pure-play and science-focused biopharma leader. On Monday, we announced that we entered exclusive negotiation with CD&R to sell a controlling stake of Opella.

    現在轉向奧佩拉。這項交易標誌著賽諾菲成為專注於科學的生物製藥領導者的重要策略一步。週一,我們宣布與 CD&R 進行排他性談判,出售 Opella 的控股權。

  • Sanofi will keep a significant stake in the company to support Opella in their independence journey and to retain part of their future value creation. We eventually selected the private option namely partnering with a world-class PE firm as it creates the highest value for our shareholders.

    賽諾菲將保留該公司的大量股份,以支持 Opella 的獨立之旅,並保留其未來價值創造的一部分。我們最終選擇了私人選擇,即與世界一流的私募股權公司合作,因為它為我們的股東創造了最高的價值。

  • The valuation at EUR16 billion EV is very attractive. The 14 times 2024 estimated EBITDA is equivalent to the trading multiples of industry peers. We expect the transaction to close in the second quarter of 2025 at the earliest. The expected proceeds from these sales will be redeployed in accordance with our capital allocation policy, ensuring we continue to invest in gross assets and deliver value to our shareholders.

    160 億歐元 EV 的估值非常有吸引力。2024年預計EBITDA的14倍相當於業界同業的交易倍數。我們預計該交易最早將於 2025 年第二季完成。這些銷售的預期收益將根據我們的資本配置政策進行重新部署,確保我們繼續投資總資產並為股東創造價值。

  • Regarding share repurchases, we are fully aware of shareholders' expectations and we will provide more specific details as we get closer to the receipt of the cash proceeds. On the other hand, we always look at external growth opportunities to complement our attractive pipeline.

    關於股票回購,我們充分了解股東的期望,隨著接近收到現金收益,我們將提供更具體的細節。另一方面,我們始終尋找外部成長機會來補充我們有吸引力的產品線。

  • We are more thinking of bolt-on acquisitions and we are not working on any large acquisitions as evidenced by our willingness to maintain our current strong credit rating, basically AA and A1 or almost AA. We will also consider how to inform investors and analysts in the future about the business performance of Opella as this will be a significant investment on our balance sheet.

    我們更考慮補強收購,我們並沒有進行任何大型收購,這一點從我們願意維持目前強勁的信用評級(基本上是 AA 和 A1 或幾乎 AA)就可以看出。我們也將考慮如何在未來向投資者和分析師通報 Opella 的業務表現,因為這將是我們資產負債表上的重大投資。

  • That concludes my presentation. I now hand over to Houman for further positive news on the pipeline.

    我的演講到此結束。我現在請侯曼了解更多有關管道的積極消息。

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

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

  • Thanks, Francois. We've achieved several milestones this quarter showing our continuous strong pace of delivery. Dupixent is now approved for COPD in more than 30 countries including the US and China where COPD is a huge unmet medical need due to widespread smoking in the local population.

    謝謝,弗朗索瓦。本季我們實現了多個里程碑,顯示了我們持續強勁的交付速度。Dupixent 現已在包括美國和中國在內的 30 多個國家獲批用於治療慢性阻塞性肺病,由於當地人口普遍吸煙,慢性阻塞性肺病是一個巨大的未滿足的醫療需求。

  • Another great milestone is the approval of Sarclisa in the US, adult patients with newly diagnosed multiple myeloma ineligible for transplantation. It's the first anti-CD38 with this data in this setting.

    另一個偉大的里程碑是 Sarclisa 在美國獲得批准,新診斷的多發性骨髓瘤成年患者不適合移植。這是在此環境下第一個具有此數據的抗 CD38。

  • Finally, we've shared several positive Phase 3 readouts, including tolebrutinib, one of our BTK inhibitors, which is notable for its effect on disability improvement in MS. Business development, including strategic investments in external innovation is a well-integrated part of the Sanofi efforts to continually access promising scientific developments into replenish our pipeline.

    最後,我們分享了幾個積極的 3 期數據,包括我們的 BTK 抑制劑之一托布替尼 (tolebrutinib),它對改善多發性硬化症的殘疾具有顯著的效果。業務發展,包括對外部創新的策略性投資,是賽諾菲不斷利用有前景的科學發展來補充我們的產品線的努力的一個很好的組成部分。

  • We invested in MeiraGTx with high interest in their technology within immunology and neurology. We've invested in Ventyx, focused on autoimmune and inflammatory disorders with an NLRP3 inhibitor in Phase 2.

    我們投資了 MeiraGTx,對他們在免疫學和神經學領域的技術非常感興趣。我們投資了 Ventyx,該公司專注於使用 NLRP3 抑制劑治療自體免疫和發炎性疾病,目前處於第二階段。

  • Another biotech company that piqued our interest focused on immunology was an AnaptysBio with its potential best-in-class Phase 2b PD-1 agonist tested in RA and UC and in Vicore with their potential best in class Phase 2b angiotensin 2 type 2 receptor agonist in IPF.

    另一家引起我們對免疫學興趣的生物技術公司是AnaptysBio,其潛在的同類最佳2b 期PD-1 激動劑在RA 和UC 中進行了測試,而Vicore 則在RA 和UC 中測試了其潛在的同類最佳2b 期血管張力素2 2 型受體激動劑。

  • Lastly, we completed a licensing agreement with RadioMedix, and Orano Med for AlphaMedix, a best-in-class radio ligand based on alpha emitting isotopes for rare cancers. We will keep you updated as we continue to access external optionality for our pipeline and complement the work we're doing internally in research.

    最後,我們與 RadioMedix 和 Orano Med 簽署了 AlphaMedix 的許可協議,AlphaMedix 是一種基於 α 發射同位素的罕見癌症的一流放射性配體。當我們繼續為我們的管道獲取外部選項並補充我們內部研究工作時,我們將隨時向您通報最新情況。

  • On the next slide, last month at the ECTRIMS conference, we presented to its Phase 3 data in RMS and nrSPMS. We didn't meet the primary endpoint in the relapsing multiple square study. However, pooled analysis of six month data to CDW, this key secondary endpoint showed a considerable delay in time to onset, which supported the impressive results in non-relapsing secondary progressive SPMS.

    在上個月的 ECTRIMS 會議上的下一張投影片中,我們展示了 RMS 和 nrSPMS 中的第 3 階段數據。我們沒有達到復發多重平方研究的主要終點。然而,對 CDW(這一關鍵次要終點)六個月數據的匯總分析顯示,發病時間有相當大的延遲,這支持了非複發性繼發進展性 SPMS 的令人印象深刻的結果。

  • In SPMS, tolebrutinib delayed the to onset of six month CDP by 31% with further analysis secondary endpoint showing that a number of participants who experienced confirmed disability improvement increased by nearly twofold, significant effect of the lowering of the annualized rate of new or enlarging T2 lesions compared to placebo.

    在SPMS 中,托布替尼將6 個月CDP 的發作延遲了31%,進一步分析次要終點顯示,經歷了確認的殘疾改善的參與者數量增加了近兩倍,新的或擴大的T2 年化率降低的顯著效果與安慰劑相比的病灶。

  • Liver enzyme animations are common to the BTKi class. In our studies, most cases resolved with that [sequeli]. They all occurred in the first 90 days. Accordingly, we focused our intense liver monitoring in that [period]. I'm confident in tolebrutinib for SPMS, patients which could offer a first option where no effective treatment helping improve disability has yet been approved.

    肝酵素動畫在 BTKi 類中很常見。在我們的研究中,大多數案例都是這樣解決的[續集]。它們都發生在前 90 天內。因此,我們將重點放在肝臟監測[時期]。我對托布替尼治療 SPMS 充滿信心,對於尚未批准有助於改善殘疾的有效治療方法的患者來說,托布替尼可以提供第一選擇。

  • Turning to amlitelimab, our OX40 ligand inhibitor molecule, we recently presented new Phase 2b atopic dermatitis data from the 68 week STREAM-AD study at the EADV conference. The study had three parts, the first one of the primary endpoint percentage change in EASI was made at 16 weeks, followed by a second part for 28 weeks where most patients saw a durability of clinical response after withdrawal at 24 weeks. And the safety follow up at 16 weeks.

    談到 amlitelimab(我們的 OX40 配體抑制劑分子),我們最近在 EADV 會議上展示了來自 68 週 STREAM-AD 研究的新 2b 期異位性皮膚炎數據。研究分為三個部分,第一個部分的EASI 主要終點百分比變化是在16 週時進行的,第二部分是在28 週時進行的,其中大多數患者在24 週停藥後看到了臨床反應的持久性。並在16週時進行安全性追蹤。

  • Throughout the 68 weeks, amlitelimab demonstrated a pleasing safety profile with most patients reporting TEAEs, which were very mild or moderate in severity and none led to discontinuation of the treatment emphasizing the differentiated safety profile complementing its confirmed efficacy.

    在整個68 週的時間裡,amlitelimab 表現出了令人滿意的安全性,大多數患者報告了TEAE,其嚴重程度非常輕微或中度,並且沒有導致治療停止,強調差異化的安全性與其已證實的療效相輔相成。

  • Durability was demonstrated with a sustained percentage of [AESI] change after amlitelimab cessation. Potential dosing and development up to 12 weeks with the potential for disease modification and therapy free remission not seen with any current medicine is envisioned.

    停用 amlitelimab 後,[AESI] 變化的持續百分比證明了耐久性。預計潛在的劑量和開發長達 12 週,具有任何現有藥物都未曾見過的疾病改善和無治療緩解的潛力。

  • All Phase 3 studies in the OCEANA program are ongoing readouts are planned in 2026. The objective of the next slide is to present our work in immunology to the community where we present the breadth of our immunology portfolio where we persist with innovation to serve patients' needs. We're increasingly focused across all stages and grades of diseases and patients we serve which are being addressed by approved in development medicines.

    OCEANA 計劃中的所有 3 期研究正在進行中,計劃於 2026 年進行讀數。下一張投影片的目標是向社區展示我們在免疫學方面的工作,展示我們免疫學產品組合的廣度,我們堅持創新以滿足患者的需求。我們越來越關注我們所服務的所有階段和級別的疾病和患者,這些問題正在透過批准的開發藥物來解決。

  • Each of these diseases has distinct characteristics leading to the informed use of our medicines and specific progression stages of disorders. Increasing options can only be beneficial to patients in areas where there is still significant unmet need.

    這些疾病中的每一種都有獨特的特徵,導致我們的藥物的明智使用和疾病的特定進展階段。增加選擇只會對那些仍存在大量未滿足需求的地區的患者有利。

  • I'd like to conclude with my signature slide displaying our 18 month news flow, which continues to evolve and highlights the exciting progress supporting our increased R&D productivity that keeps on delivering. We plan six Phase 3 readouts, 11 submissions and 10 regulatory positions in multiple countries. And we look forward to keeping you updated on progress.

    最後,我想用我的簽名幻燈片來展示我們 18 個月的新聞流,這些新聞流不斷發展,並強調了支持我們不斷提高的研發生產力的令人興奮的進展。我們計劃在多個國家進行 6 項第 3 階段的讀數、11 項提交和 10 個監管職位。我們期待向您通報最新進展。

  • We are humble in the face of disease and regrettably not everything will work. But I am optimistic about this unique pipeline in our core focused therapeutic areas and the service of patients. Before handing back to Paul, I would like to extend a warm welcome to our new Head of Research, Micheal Quigley. I'm eagerly anticipating our future collaboration and confident that his expertise will contribute to our continued efforts to enhance our R&D productivity and the quality of our pipeline over time.

    面對疾病,我們保持謙虛,遺憾的是並非一切都會奏效。但我對我們核心重點治療領域和患者服務中的這一獨特管道感到樂觀。在交回 Paul 之前,我要熱烈歡迎我們新任研究主管 Micheal Quigley。我熱切期待我們未來的合作,並相信他的專業知識將有助於我們不斷努力提高我們的研發生產力和產品線的品質。

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

    有了這個,我將問題交還給保羅。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Well, thank you, Houman. We'll now have the call to your questions. (Event Instructions)

    嗯,謝謝你,侯曼。我們現在將接聽您的問題。(活動須知)

  • Operator

    Operator

  • Richard Vosser, J.P. Morgan.

    理查沃瑟,摩根大通。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Hopefully you can hear me. It's Richard Vosser from J.P. Morgan. Two questions, please. First question on Beyfortus. How are you thinking about the commercial potential beyond this season following the ACIP meeting discussing the Merck Clesrovimab, I can never say data this year. Just to continue with that.

    希望你能聽到我的聲音。我是摩根大通的理查沃瑟。請教兩個問題。關於 Beyfortus 的第一個問題。在 ACIP 會議討論 Merck Clesrovimab 之後,您如何看待本季之後的商業潛力,我永遠無法說出今年的數據。只是為了繼續這樣做。

  • And the second question is just on the Opella deal. How should we think about the high single-digit billion proceeds? How much of that would be realized by debt pass-through from a pass down to Opella.

    第二個問題是關於奧佩拉交易的。我們該如何看待數十億美元的高額收益?其中有多少是透過將債務轉嫁給奧佩拉來實現的。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Richard, Beyfortus is very easy to say. Thomas?

    謝謝理查德,Beyfortus 說起來很容易。托馬斯?

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • I can't say the other one. Thanks for the question, Richard. Very good point indeed. A few first point to start with. First of all, there's still a lot to go in terms of monoclonal antibody penetration.

    其他的我就說不出來了謝謝你的提問,理查德。確實很好。首先先講幾點。首先,單株抗體的滲透率還有很長的路要走。

  • So we really welcome that there is more players to come because it will increase the size of the playfield basically. What is very important is that monoclonal antibodies have shown they are the only pathway to be able to really protect all infants. And if we are two, we will be more than one to actually sing that song and make sure that more and more babies get productive moving forward.

    所以我們非常歡迎有更多的玩家加入,因為這基本上會增加比賽場地的大小。非常重要的是,單株抗體已表明它們是能夠真正保護所有嬰兒的唯一方法。如果我們是兩個人,我們將不僅僅是一個人來真正唱這首歌,並確保越來越多的嬰兒能夠繼續前進。

  • Now, in terms of the ACIP presentation, as you were pointing out too, they were showing still some important difference between the two products it's still early data for competitors. We've seen just some data, not all of it. We are very confident in the data that we have demonstrated in both our Phase 3 and our rewarded evidence data. Be it in actual efficacy or in its pristine safety or the duration of protection.

    現在,就 ACIP 演示而言,正如您也指出的那樣,他們展示了兩種產品之間仍然存在一些重要差異,這對於競爭對手來說仍然是早期數據。我們只看到了一些數據,而不是全部。我們對第三階段所展示的數據和獎勵證據數據非常有信心。無論是實際功效還是原始安全性或保護持續時間。

  • So, looking forward and I'm sure we'll have many opportunities. We'll be able to show the differences between the two products.

    所以,展望未來,我相信我們會有很多機會。我們將能夠展示這兩種產品之間的差異。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Francois, Opella deal and proceed.

    弗朗索瓦和奧佩拉達成協議並繼續進行。

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • So on the Opella deal, indeed I confirm that we expect to receive at the earliest in Q4 2025 a high single digit number in billions of euros, once again, not earlier than Q2. Just one small comment on the amounts, it's equivalent to the disposal of slightly more than 50% stake in the company. We will get the benefit of the debt push down because obviously the company will very highly leverage minus we need to pay taxes and there are some transaction costs as well.

    因此,關於 Opella 交易,我確實確認,我們預計最早將在 2025 年第四季收到數十億歐元的高個位數數字,而且不會早於第二季。僅就金額而言,就相當於處置了該公司略高於50%的股權。我們將從債務壓低中受益,因為顯然該公司的槓桿率非常高,減去我們需要納稅,而且還有一些交易成本。

  • The cash proceeds, so we don't expect to get them at the earliest in Q2. So it's a little bit early to talk about that. Obviously, we use will be fully in line with our capital allocation policy, which is essentially around investing in our business, which is already what we do.

    現金收益,因此我們預計最早不會在第二季獲得現金。所以現在談論這個還為時過早。顯然,我們的使用將完全符合我們的資本配置政策,這基本上是圍繞投資我們的業務,這已經是我們所做的。

  • On the M&A side, we keep looking at opportunities in the market. We are talking essentially on bolt-on acquisitions. We are not talking of large acquisitions as evidenced by the fact that we gave some assurance on our intention to retain a double rate.

    在併購方面,我們不斷尋找市場機會。我們主要討論的是補強收購。我們並不是談論大型收購,這一點可以從我們對保留雙倍利率的意圖做出一些保證這一事實得到證明。

  • We will maintain our dividend policy to increase our dividend in absolute value in euros as we have always done -- already done over the last 30 years. And we will obviously look at anti-dilutive share buybacks. We heard loud and clear, our shareholder expectation regarding share repurchases. So which is something that we have discussed in the past? So we heard very, very clearly the appetite of our shareholders for that part of our capital allocation.

    我們將維持股息政策,以增加歐元絕對值股息,正如我們過去 30 年來一直在做的那樣。我們顯然會考慮反稀釋性股票回購。我們清楚聽到股東對股票回購的期望。那我們過去討論過哪些內容呢?因此,我們非常非常清楚地聽到股東對這部分資本配置的興趣。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you. Next question, please.

    謝謝。請下一個問題。

  • Operator

    Operator

  • Emily Field, Barclays.

    艾米麗·菲爾德,巴克萊銀行。

  • Emily Field - Analyst

    Emily Field - Analyst

  • Hi, Emily Field from Barclays. Thanks for taking my question. I'll ask two. First one on Dupixent. I was just wondering, I know it's very early days for the launch in COPD. If you could give us any sort of early metrics about how you're seeing that launch and this new indication and just how you're thinking about the softness of the launch curve now that you're out there in the field.

    你好,巴克萊銀行的艾米麗·菲爾德。感謝您提出我的問題。我就問兩個Dupixent 上的第一個。我只是想知道,我知道在慢性阻塞性肺病領域推出還為時過早。如果您能給我們任何早期指標,說明您如何看待該發布和這個新的跡象,以及您現在如何看待發布曲線的柔軟度,因為您已經在現場了。

  • And then that was a very helpful answer on use of proceeds for Opella, but I just wanted to see if I could get perhaps a little bit more color just because one of the questions that we've been getting frequently this week is with regards to just how much of the dilution from the sale of Opella could be offset with a share purchase. So I was just wondering if perhaps you could provide any more specific comments on that point, that would be very helpful. Thank you.

    這是關於 Opella 收益使用的一個非常有用的答案,但我只是想看看我是否可以獲得更多的色彩,因為我們本週經常收到的問題之一是關於出售Opella 所帶來的稀釋有多少可以透過股票購買來抵消。所以我只是想知道您是否可以就這一點提供更具體的評論,這將非常有幫助。謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Emily. Brian, Dupi, early thoughts on COPD launch.

    謝謝你,艾米麗。Brian、Dupi,關於 COPD 推出的早期想法。

  • Brian Foard - Head of the Specialty Medicine Entity, Member of the Executive Committee

    Brian Foard - Head of the Specialty Medicine Entity, Member of the Executive Committee

  • Yeah, Emily, thank you so much for the question. Obviously, we share your excitement for COPD. As has the marketplace as we've seen it now. It's very early days. So we're just under a month of being out there in the United States. But as we had articulated before, this is a disease state, third leading cause of death worldwide, no new meaningful innovation in the past 10 years.

    是的,艾米麗,非常感謝你的提問。顯然,我們和您一樣對慢性阻塞性肺病感到興奮。正如我們現在所看到的市場。現在還為時過早。所以我們在美國的日子還不到一個月。但正如我們之前所闡明的,這是一種疾病狀態,也是全球第三大死因,過去 10 年沒有新的有意義的創新。

  • So you can imagine that the marketplace is very excited, it's too early to comment on trends. What I can tell you is that the feedback has been extremely positive in the marketplace. And this really sets us up very nicely, I think as we've talked about before, this is just the beginning of our COPD journey.

    所以你可以想像市場非常興奮,現在評論趨勢還為時過早。我可以告訴你的是,市場的回饋非常正面。這確實讓我們做好了準備,我認為正如我們之前討論過的,這只是我們慢性阻塞性肺病之旅的開始。

  • So we have another pipeline asset as well that's coming directly behind this. And I think the early feedback gives us even more confidence in that and the guidance that we previously provided that the two of those will likely be somewhere in the range of $5 billion at peak.

    因此,我們還有另一個管道資產直接位於此之後。我認為早期的回饋讓我們對此更有信心,我們先前提供的指導也表明這兩項資金的高峰可能在 50 億美元左右。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Yeah, Francois.

    好的。是的,弗朗索瓦。

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • Emily, on the use of proceed on the dilution, let me clarify something first because I saw some analysis saying that the dilution linked to the separation of Opella was 11%. It is linked to the year 2023. Actually, for 2024 it will be closer to 9% given that our biopharma business has grown quite a lot in the meantime. I'm not going to provide you more color on the dilution -- on the anti-dilution activities that we could do and especially share buyback.

    Emily,關於稀釋的繼續使用,讓我先澄清一些事情,因為我看到一些分析說與 Opella 分離相關的稀釋度是 11%。它與 2023 年相關。事實上,考慮到我們的生物製藥業務在此期間增長了很多,到 2024 年,這一比例將接近 9%。我不會向您提供有關稀釋的更多資訊 - 關於我們可以採取的反稀釋活動,特別是股票回購。

  • And the portion of it that will mitigate the dilution. What I can tell you, though, is that don't be too worried about the dilution in 2024 because our business EPS in 2025 will increase over 2024 in absolute value regardless of I mean, even before any anti-dilution activities that we could go for. So our business EPS will increase. I must just say in at constant exchange rate will increase in 2025 over 2024 and it will increase over '24 even with or without a pillar. So the dilution will be anywhere even before anti-dilution activities will be absorbed.

    以及將減輕稀釋的部分。不過,我可以告訴你的是,不要太擔心2024 年的稀釋,因為我們2025 年的業務每股收益的絕對值將比2024 年增加,無論我的意思是什麼,甚至在我們可以採取任何反稀釋活動之前為了。所以我們的業務每股盈餘將會增加。我必須說,以固定匯率計算,2025 年的匯率將比 2024 年成長,而且無論有沒有支柱,24 年都會成長。因此,甚至在反稀釋活動被吸收之前,稀釋就會發生在任何地方。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you next question, please.

    謝謝你,請下一個問題。

  • Operator

    Operator

  • Graham Parry, BofA.

    格雷厄姆·帕里,美國銀行。

  • Graham Parry - Analyst

    Graham Parry - Analyst

  • Great. Thanks for taking my questions. So, firstly, on Beyfortus just wondered of the EUR1.5 billion guidance that you're pointing to for the year now, just which countries are assumed in that? And roughly what sort of penetration do you target in key markets such as US, France, Germany and are there any more markets to come still that that are not mentioned in the press release today?

    偉大的。感謝您回答我的問題。因此,首先,Beyfortus 只是想知道您現在指出的今年 15 億歐元的指導,其中假設了哪些國家?您在美國、法國、德國等主要市場的目標滲透率大致是多少?

  • And then secondly, on buybacks and just could you remind us of your current buyback authority that you have from the board and how much of that is left to execute an independence of Opella or any cash receipts there? Is there anything that stops Sanofi from executing a buyback today or before Q2 next year, for example? Thank you.

    其次,關於回購,您能否提醒我們,您目前從董事會獲得的回購權,以及還剩下多少權力來執行 Opella 的獨立性或那裡的任何現金收入?例如,是否有任何因素阻止賽諾菲今天或明年第二季之前執行回購?謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay, thank you. I mean, Graham, thank you. Yeah, Beyfortus, Thomas?

    好的,謝謝。我的意思是,格雷厄姆,謝謝你。是啊,貝弗特斯,托馬斯?

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • Graham. So as we indicated, we launched in 2024 and close to 20 countries which includes, of course, North America, Western Europe market, of course, last year whether we launched in Spain or in France, but we expanded to various markets including and we talked about it in the past before, that includes Portugal, that includes Germany, that includes Italy, that includes Belgium and a few others.

    格雷厄姆.因此,正如我們所指出的,我們在 2024 年推出了近 20 個國家/地區,當然包括北美、西歐市場,當然,去年無論我們在西班牙還是法國推出,但我們擴展到了各個市場,包括我們以前講過,包括葡萄牙,包括德國,包括義大利,包括比利時和其他一些國家。

  • And we had a couple of South America countries that was disclosed in the in previous earnings. So most of the current launch has been done in those markets. So really focusing on North America and Western Europe and there are more markets in which we will launch next year.

    我們在先前的收益中披露了幾個南美國家的情況。因此,目前的大部分發布都是在這些市場完成的。因此,我們真正關注的是北美和西歐,明年我們將在更多市場推出。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Thomas. And then the other part about the buyback. Just as you would imagine, particularly having entered into this period with Opella. We have an ongoing and active conversation with the board on buybacks as you would expect. And when we're ready to communicate our capital allocation decisions, we will, of course, share that with you immediately. Okay. Next question.

    謝謝你,托馬斯。然後是關於回購的另一部分。正如你所想像的那樣,尤其是與奧佩拉一起進入這個時期。正如您所期望的那樣,我們與董事會就回購問題進行了持續、積極的對話。當我們準備好傳達我們的資本配置決策時,我們當然會立即與您分享。好的。下一個問題。

  • Operator

    Operator

  • Seamus Fernandez, Guggenheim.

    謝默斯·費爾南德斯,古根漢。

  • Seamus Fernandez - Analyst

    Seamus Fernandez - Analyst

  • Thanks for the question. So just a couple. First on your strategy with amlitelimab. Just wanted to get a better sense of the importance of asthma in that data set. And then also how you're deciding to move forward with your OX40 TNF given the data that are coming roughly around a similar time frame for that by specific antibody.

    謝謝你的提問。所以只是一對。首先是關於 amlitelimab 的策略。只是想更了解該資料集中氣喘的重要性。然後,考慮到特定抗體在大致相似的時間範圍內得出的數據,您將如何決定繼續使用 OX40 TNF。

  • And then incremental to some of the questions that have been asked. Just wanted to get a better sense of your commitment to the strong growth recovery that you've talked about in the past, I think now the consensus expectation is for anywhere from 15% to 18% growth year over year. And it seems like there's a potential acceleration in the overall biopharma business that could be coming with the removal of Opella from the base business.

    然後逐步回答一些已提出的問題。只是想更了解您對過去談到的強勁成長復甦的承諾,我認為現在的共識預期是年增 15% 至 18%。隨著 Opella 從基礎業務中剔除,整個生物製藥業務似乎可能會加速。

  • So just wanted to get a better sense of how we're thinking about the year-over-year growth expectation and opportunity there. Thanks so much.

    因此,我只是想更了解我們如何看待同比成長預期和機會。非常感謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay, Seamus. Well, why don't we start with Houman on amlitelimab and asthma and for the ligand TNF, and then Francois to comment on the strong recovery for next year and the numbers which I'm unfamiliar with that you mentioned.

    好的,西莫。好吧,我們為什麼不先由 Houman 談談 amlitelimab 和哮喘以及配體 TNF,然後由 Francois 來評論明年的強勁復甦以及您提到的我不熟悉的數字。

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

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

  • Seamus, thank you for the question. We're more confident than ever about the importance of the OX40, OX40 ligand pathway in disease as you've seen from our data and atopic dermatitis, we feel that we are best in class by virtue of targeting the ligand, which gives us a biological distinction, both from a durability and efficacy perspective, but also from a safety perspective to mitigate, for example, chills and other impact.

    西莫,謝謝你的提問。我們比以往任何時候都更相信OX40、OX40 配體途徑在疾病中的重要性,正如您從我們的數據和異位性皮膚炎中看到的那樣,我們認為我們憑藉靶向配體而成為同類中最好的,這為我們提供了生物學上的區別,既從耐久性和功效的角度來看,又從安全的角度來看,以減輕例如寒顫等影響。

  • Specifically with respect to asthma, OX40 ligand is an apical node in many inflammatory processes. We have a great target credentialing across multiple indications and we have been deeply committed to patients with asthma already with Dupixent and a number of other agents.

    特別是對於氣喘,OX40 配體是許多發炎過程中的頂端節點。我們在多種適應症方面擁有出色的目標認證,我們一直致力於使用 Dupixent 和許多其他藥物來治療氣喘患者。

  • We are committed to the asthma franchise and we hope that amlitelimab will in due course next year, provide the data to support forward motion in that position. A short comment on your bispecifics. Thank you for bringing that into focus. Of course, they're internally developed molecules. We're confident now about our internal research and discovery activity. We're humble in the face of disease. We're not complacent, but we're excited to be generating a suite of internal molecules.

    我們致力於哮喘領域的業務,我們希望 amlitelimab 能夠在明年的適當時候提供數據來支持這一職位的前進。對你的雙特異性的簡短評論。感謝您讓我們關注這一點。當然,它們是內部開發的分子。我們現在對我們的內部研究和發現活動充滿信心。面對疾病,我們保持謙虛。我們並不自滿,但我們很高興能夠生成一套內部分子。

  • This one is of course, the second one. You know about the lunsekimig again showing you are with asthma. We look forward to the results of the double punch of blocking TNF and OX40. And a disease that we know is from a credentialing perspective, influenced by TNF and OX40. Both of those results will come in the first half of next year and we look forward to discussing.

    這當然是第二個。您知道 lunsekimig 再次顯示您患有氣喘。我們期待阻斷TNF和OX40雙拳的結果。我們所知道的一種疾病是從認證的角度來看,受 TNF 和 OX40 的影響。這兩項結果都將於明年上半年公佈,我們期待進行討論。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Houman. And yeah, I mean, we have, AD is obviously a huge opportunity for amlitelimab. But asthma based on the interval if we can get there would be a really great play. Francois?

    謝謝你,侯曼。是的,我的意思是,AD 顯然對 amlitelimab 來說是一個巨大的機會。但如果我們能做到基於氣喘的間隔,那將是一場非常精彩的比賽。弗朗索瓦?

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • First and foremost, what is important to understand is exactly what you said, which is with Sanofi as a pure biopharma company, we have a better gross profile and margin profile without Opella. We confirm as well the fact that we expect a strong rebound in business EPS in 2025.

    首先也是最重要的,重要的是要理解你所說的,賽諾菲作為一家純粹的生物製藥公司,如果沒有歐佩拉,我們的毛利率和利潤率會更好。我們也確認了一個事實,我們預計 2025 年企業每股收益將強勁反彈。

  • The figure you mentioned is significantly above the consensus, which is around 12% to 13% for the time being. Don't forget, one thing is that we have accelerated already in 2024 our business EPS, we revised our guidance supports twice. At the end of Q2 and just now and at the end of Q3, so we have -- we are bringing forward to a certain extent the rebound. That being said, we do confirm still a strong rebound for 2025 but over a higher base in 2024 given that we have accelerated the rebound already starting in 2024.

    你提到的數字明顯高於市場共識,目前約12%至13%。不要忘記,一件事是我們已經在 2024 年加速了我們的業務每股收益,我們兩次修改了我們的指導支援。在第二季末、剛才和第三季末,我們在某種程度上提前了反彈。話雖如此,我們確實確認 2025 年仍將出現強勁反彈,但考慮到我們從 2024 年開始就已經加速了反彈,因此 2024 年的基礎會更高。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you. Next question.

    好的。謝謝。下一個問題。

  • Operator

    Operator

  • Joe Walton, UBS.

    喬沃爾頓,瑞銀集團。

  • Jo Walton - Analyst

    Jo Walton - Analyst

  • Thank you. Just to clarify to confirm that when you present your full year '24 numbers, they will be on the new basis. So we won't be at least on the headline basis, seeing the sales of Opella and all the earnings through, that will all be just a single disconntinued line item that won't be in your business EPS.

    謝謝。只是為了澄清並確認,當您提供 24 年全年數據時,它們將基於新的基礎。因此,我們至少不會在標題的基礎上看到 Opella 的銷售額和所有收益,這只是一個停產的訂單項,不會出現在您的業務每股收益中。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Jo.

    喬.

  • Jo Walton - Analyst

    Jo Walton - Analyst

  • Excellent. And the other clarification, if you could give us any help on the tax rate that might be expected in FY25 just given the comments about potential higher tax in France, if you could just give us a sense of what that might do. But my main question is, please, any help you can give us on negotiations for IRA for next year in the US.

    出色的。另一項澄清是,鑑於有關法國可能提高稅收的評論,您能否就 25 財年預期的稅率向我們提供任何幫助,如果您能讓我們了解這可能會產生什麼作用。但我的主要問題是,請您為我們明年在美國進行 IRA 談判提供任何幫助。

  • Other companies have said that the loss of rebates, particularly in immunology because of the loss of the Humira rebates has made PBMs particularly hard in their negotiations for 2025 for rebates. And of course, we note that Dupixent gets the first sort of proper competitor with EBGLYSS from a major player that can also give heavy rebates for next year. So I wonder if you could talk a little bit about that, please.

    其他公司表示,回扣的損失,特別是由於修美樂(Humira)回扣的損失而導致的免疫學回扣的損失,使得 PBM 在 2025 年的回扣談判中尤其困難。當然,我們注意到 Dupixent 從主要參與者那裡獲得了 EBGLYSS 的第一個適當的競爭對手,該參與者還可以在明年提供巨額回扣。所以我想知道你是否可以談談這個問題。

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • Jo. So just to be clear because we sort of talked as well while you were talking no Opella in the full year results. So that I confirmed already. And maybe Francois speaking, I can give you a little bit more color on the tax rate. As you probably saw with the new scope without Opella, our underlying tax rate will go down from 21% with the scope to about 20% with the new scope.

    喬.需要澄清的是,當您談論全年業績中沒有奧佩拉時,我們也進行了交談。所以我已經確認了。也許弗朗索瓦說,我可以給你更多關於稅率的資訊。正如您可能在沒有 Opella 的新瞄準鏡中看到的那樣,我們的基本稅率將從使用該瞄準鏡的 21% 降至使用新瞄準鏡的 20% 左右。

  • I want to mention as well that with the new tax laws in France, we do expect an increase of our taxes in France. You may have seen that some of our peers in the CAC 40 have already disclosed significant amounts of taxi increases. We will be probably at the lower end of some of the figures that have been mentioned by some of our peers in France.

    我還想提一下,隨著法國新稅法的實施,我們確實預期法國的稅收會增加。您可能已經看到,CAC 40 中的一些同行已經揭露了計程車的大幅成長。我們可能處於法國一些同行提到的一些數字的較低端。

  • And I want to reassure you as well that we do expect that probably in 2025 with what we know today, it's still early, that underlying tax rate should remain relatively similar globally in spite of what's happening in France, similar to what we expect in 2025 around 20%, given that we have ways to mitigate it outside of France.

    我還想向您保證,我們確實預計到 2025 年,就我們今天所知,現在還為時過早,儘管法國發生了什麼,但全球基礎稅率應該保持相對相似,與我們 2025 年的預期類似大約20%,因為我們有辦法在法國以外的地區減輕影響。

  • And we have some other countries that are reducing their tax rates and so forth. And with the mix of our geographies and activities we should be able to maintain in 2025 with what we know today the tax rate around 20% next year.

    我們還有其他一些國家正在降低稅率等等。考慮到我們的地理位置和活動的組合,我們應該能夠在 2025 年將明年的稅率維持在我們今天所知的 20% 左右。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Francois. And maybe Brian, do you want to respond to that question.

    謝謝你,弗朗索瓦。也許布萊恩,你想回答這個問題嗎?

  • Brian Foard - Head of the Specialty Medicine Entity, Member of the Executive Committee

    Brian Foard - Head of the Specialty Medicine Entity, Member of the Executive Committee

  • Yeah, I'm happy to tackle it overall. So first and foremost, Jo, I think is from an environment standpoint, the Inflation Reduction Act, there's a couple of things in there. And as we've said before, our position is it's not really good for innovation just in general, the Inflation Reduction Act that said there are some pieces in there that we do agree with which -- one of which is actually quite good for patients is the no more than $2,000 out of pocket.

    是的,我很高興能夠從整體上解決這個問題。首先,喬,我認為從環境的角度來看,《降低通貨膨脹法案》中有幾項。正如我們之前所說,我們的立場是,總體而言,這對創新並不真正有利,《減少通貨膨脹法案》說,其中的一些內容我們確實同意——其中之一實際上對患者非常有利是自掏腰包不超過2,000 美元。

  • And the ability to spread that across the months could potentially allow these patients to have access to medicines that they haven't had before in the past. And we think that's a good thing. So that's a positive side of things. From an IRA standpoint, our portfolio actually lends us very well to this, because we have an innovative portfolio, we have an innovative pipeline coming and that's what we see is the US marketplace really values innovation. And so we don't really see any meaningful impact on our there in for any reason for that matter, especially in relation to how the pricing provisions that are in place.

    如果能夠將這種情況分散到幾個月內,這些患者就有可能獲得他們過去從未獲得過的藥物。我們認為這是一件好事。所以這是事情積極的一面。從 IRA 的角度來看,我們的投資組合實際上非常適合我們,因為我們擁有創新的投資組合,我們有一個即將到來的創新管道,這就是我們所看到的美國市場真正重視創新。因此,我們實際上並沒有看到任何有意義的影響,特別是在定價條款的製定方面。

  • Now, it relates to overall negotiation with payers. Again, I'll remind you specifically now on Dupixent because that was where the question was coming from, probably we find ourselves in an excellent position. First and foremost, we have great underlying demand growth, that's where our growth is coming from.

    現在,它涉及與付款人的整體談判。再次,我現在會在 Dupixent 上特別提醒您,因為這就是問題的來源,也許我們發現自己處於一個絕佳的位置。首先也是最重要的是,我們有龐大的潛在需求成長,這就是我們成長的來源。

  • And we find ourselves in a good position because we've been executing a very clear strategy with the payers for quite some time to ensure as we expand indications that we're able to gain access whether it's new channels and we find ourselves in a good position and this is all taken into our guidance as we've provided to you for $13 billion this year as a target or around $13 billion and a double-digit CAGR growth from '23 through 2030.

    我們發現自己處於有利的位置,因為相當長一段時間以來,我們一直在與付款人執行非常明確的策略,以確保隨著我們擴大跡象,我們能夠獲得訪問權限,無論是新渠道,並且我們發現自己處於良好的境地。增長率。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Brian. Next question.

    謝謝你,布萊恩。下一個問題。

  • Operator

    Operator

  • Peter Welford, Jefferies.

    彼得‧韋爾福德,傑弗里斯。

  • Peter Welford - Analyst

    Peter Welford - Analyst

  • One, first of all, coming back to the 2025. I wonder if you could provide perhaps a little bit more help for us on a few items that would help perhaps narrow the range a bit for consensus. Firstly, is there any potential stranded costs that we should think about from the Opella in 2025 that will then become freed in perhaps in 2026.

    一,首先回到2025年。我想知道您是否可以在一些項目上為我們提供更多幫助,這可能有助於縮小範圍以達成共識。首先,我們應該考慮 2025 年 Opella 是否存在任何潛在的滯留成本,這些成本可能會在 2026 年釋放。

  • And also, just you made the comment on the sales and marketing that you've brought forward some of the investments to support the launches, how should we think about that perhaps going into 2025? And then the second question is on Phase 3 trials for new vaccines and I guess the question here is, first of all, with the Novavax and the deal you've done for the combination flu, would your intention be to run an efficacy study as you talked about for that.

    而且,剛剛您對銷售和行銷發表了評論,表示您已經提出了一些投資來支持發布,我們應該如何考慮可能進入 2025 年的情況?第二個問題是關於新疫苗的第三階段試驗,我想這裡的問題是,首先,對於 Novavax 以及您為混合流感所做的交易,您是否打算進行一項功效研究你談到了這一點。

  • And similarly, there's an FDA VRBPAC meeting, I think, the meeting has been called on the December 12 to discuss pediatric RSV. Curious if you've been asked to participate in that because as far as I'm aware, you're the only Phase 3 pediatric RSV vaccine currently that is in the clinic. Thank you.

    同樣,FDA VRBPAC 會議將於 12 月 12 日召開,討論兒科 RSV。我很好奇您是否被邀請參加,因為據我所知,您是目前臨床上唯一的 3 期兒科 RSV 疫苗。謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Peter, thank you very much. So François stranded cost, and if they need to do about the Opella.

    彼得,非常感謝你。因此,弗朗索瓦陷入了困境,他們是否需要對歐佩拉採取行動。

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • Yeah stranded cost, there will be some, but there is nothing material in new stranded cost by definition. We will have to limit them over time. So I would not be specifically worried about that. We can absorb them even including in 2025. In sales and marketing, as you can see, we invest a little bit more than we originally planned, but given that we have a very strong momentum on the top line, I'm comfortable with it. I think it makes sense anyway and we are -- so I think that there will be probably a bit of it in 2025 as well, but nothing major.

    是的,擱淺成本,會有一些,但根據定義,新擱淺成本中沒有任何實質內容。隨著時間的推移,我們將不得不限制它們。所以我不會特別擔心這一點。甚至包括2025年我們也可以吸收它們。正如您所看到的,在銷售和行銷方面,我們的投資比最初計劃的要多一些,但鑑於我們在營收方面擁有非常強勁的勢頭,我對此感到滿意。我認為無論如何這是有道理的——所以我認為 2025 年可能也會有一些,但不會有什麼重大的。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you. Thomas, Novavax and PED RSV meeting.

    謝謝。Thomas、Novavax 和 PED RSV 會議。

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • So thanks for the question. So the PED RSV meeting that was called for -- you probably have seen the invitation. It's a very generic one. So we've not been particularly invited, but we will show up at the gate, and we'll be there. And as you mentioned, with our RSV polio vaccines, which is currently in Phase 3, going very strongly with the environment. I think we are very well-positioned for that vaccine, depending, of course, on the Phase 3 outcome.

    謝謝你的提問。因此,您可能已經看到了所要求的 PED RSV 會議。這是一個非常通用的。所以我們沒有被特別邀請,但我們會出現在門口,我們會在那裡。正如您所提到的,我們的 RSV 小兒麻痺疫苗目前處於第三階段,與環境的關係非常密切。我認為我們已經為該疫苗做好了充分準備,當然這取決於第三階段的結果。

  • Second point you were mentioning Novavax, our strategy is absolutely the same as the first day one. We are moving forward to start the Phase 1/2 this year where we want to showcase that we can do outflow with Novavax COVID-19 together in a combination vaccine that does not compromise neither on safety, nor on efficacy. And our intention is once we have results, if positive, we will immediately move next year towards Phase 3, assuming Phase 1/2 positive data.

    第二點,你提到 Novavax,我們的策略與第一天的策略完全相同。我們正著手於今年開始 1/2 階段,我們希望展示我們可以與 Novavax COVID-19 一起在一種既不影響安全性也不影響功效的組合疫苗中進行流出。我們的目的是,一旦取得結果(如果是積極的),假設第 1/2 階段的數據積極,我們將在明年立即進入第 3 階段。

  • Operator

    Operator

  • Luisa Hector, Berenberg.

    路易莎·赫克托,貝倫貝格。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • The first one for Thomas, just to continue on the flu franchise. How soon do you expect a COVID flu with an ACIP recommendation to be on the market? And then second question is for Paul, five years, well done. So you've made enormous progress transforming the Sanofi business, but looking forward, R&D is the outstanding challenge.

    湯瑪斯的第一個,只是為了延續流感專營權。您預計帶有 ACIP 建議的新冠流感多久會上市?第二個問題是問保羅的,五年了,幹得好。因此,您在賽諾菲業務轉型方面取得了巨大進展,但展望未來,研發將是突出的挑戰。

  • So what or when do you see as the most critical inflection points for determining progress in the R&D transformation and how is the organization positioned to really maximize on pipeline successes, but as Houman mentioned, the inevitable failures that come with the territory. So essentially, is the pipeline big enough? And is the spend both internal and external sufficient? Thank you.

    那麼,您認為決定研發轉型進展的最關鍵的轉折點是什麼或什麼時候,以及組織如何定位才能真正最大限度地實現管道成功,但正如霍曼所提到的,該領域不可避免的失敗。那麼本質上,管道夠大嗎?內部和外部的支出是否足夠?謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. I made your report apparently. Okay. So flu COVID, ACIP.

    好的。我顯然已經向你報告了。好的。所以流感新冠肺炎,ACIP。

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • Yes. Thanks for the question, Luisa. A bit early to say. Again, what I think is very important to think is combination vaccines have a place moving forward, and we believe in it, provided and assuming that those combination vaccines do not have any conformity on safety or efficacy. I started by that because as you know very well, it's our intention to move vaccine forward.

    是的。謝謝你的提問,路易莎。說的有點早。再說一遍,我認為非常重要的是,組合疫苗有一個前進的地方,我們相信它,前提是並假設這些組合疫苗在安全性或有效性方面沒有任何一致性。我之所以這樣開始,是因為正如你們所知,我們的目的是推動疫苗的發展。

  • Now you also know that there are some competitors that are moving forward on this. Interestingly, Moderna has recognized that they need to provide efficacy data asked by the regulator on the flu component. You've seen that they are engaging on a very large phase rescale to show if there is or not superiority, clinically demonstrated with clinical outcome against standard dose flu.

    現在您也知道有一些競爭對手正在這方面取得進展。有趣的是,Moderna 認識到他們需要提供監管機構要求的流感成分的功效數據。您已經看到他們正在進行非常大的階段重新調整,以顯示是否存在優越性,並透過針對標準劑量流感的臨床結果進行臨床證明。

  • And I think it's going to be very important because you need to demonstrate clinical statistically meaningful superior efficacy versus standard dose to have a chance to be in the ACIP recommendation for 65 and above in the US. So let's put things first in order. First, we need to see what is the efficacy bar they can pass with their product.

    我認為這將非常重要,因為您需要證明與標準劑量相比具有臨床統計學意義的卓越療效,才有機會在美國獲得 65 歲及以上的 ACIP 推薦。所以我們先把事情安排好。首先,我們需要看看他們的產品可以通過什麼功效標準。

  • Second, they will need to go indeed through registration and through ACIP recommendation. In any case, I don't see them as any competitor being there in 2025. We will be there and our vaccines are leading in the marketplace and have shown a strong ability to have efficacy and very good tolerability. We will be there in 2026 or later on. We still need to see the data, which is still not coming.

    其次,他們需要確實透過註冊和 ACIP 推薦。無論如何,我不認為他們是 2025 年的競爭對手。我們將在那裡,我們的疫苗在市場上處於領先地位,並顯示出強大的功效和非常好的耐受性。我們將在 2026 年或更晚的時間到達那裡。我們仍然需要查看數據,但數據還沒到來。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Tom. For me, it's an interesting question. I mean, we studied a lot, particularly in the early part of the strategy (technical difficulty), how long it takes to do an R&D turnaround, and it was sort of five to seven years was the average if you look at some of the success stories. You know me a little bit now, and I'd like to have been faster. It wasn't to be.

    謝謝你,湯姆。對我來說,這是一個有趣的問題。我的意思是,我們研究了很多,特別是在策略的早期部分(技術難度),研發週轉需要多長時間,如果你看看一些研究,平均需要五到七年。你現在對我有一點了解了,我希望能更快。事實並非如此。

  • And so we're literally -- we see ourselves at the beginning now of that journey more proof points, more chances for success rather than failure. But we -- and we built the pipeline that well, particularly in areas that we really know like immunology, neurology vaccines, rare. And I think there's quite a bit to come. I think the reason we changed the guidance last year is because we knew '24 and '25 are going to be important years for really seeing how far we have come.

    因此,我們確實認為自己正處於這段旅程的開始階段,有更多的證據,更多成功而不是失敗的機會。但我們——而且我們很好地建立了管道,特別是在我們真正了解的領域,如免疫學、神經學疫苗等,很少見。我認為還有很多事情要做。我認為我們去年改變指導方針的原因是因為我們知道「24」和「25」將是真正看到我們已經走了多遠的重要年份。

  • Now of course, internally, we can be optimistic, but we're never far from people saying, you're as good as your next successful failures. So we've got our heads down. We're doing hard work. I think our internal governances under Houman's leadership are much more demanding, so that we try not to stub our toe on that journey.

    當然,現在,在內部,我們可以保持樂觀,但我們永遠不會遠離人們說,你和你下一次成功的失敗一樣好。所以我們低頭。我們正在努力工作。我認為,在侯曼的領導下,我們的內部治理要求更高,因此我們盡量不要在這過程中絆倒。

  • We've got more chance of really following the pathway and seeing if it gets done. Of course, there's some really exciting assets in the pipeline, but they're still early some of the TNF, for example. So if we can get these things advanced, I think it really does change the nature of the company. And I've sort of learned over time in the field that it's about getting more successes and failures, and it's such a balance.

    我們有更多的機會真正沿著這條路走下去,看看它是否能完成。當然,還有一些非常令人興奮的資產正在醞釀中,但它們仍然處於早期階段,例如 TNF。因此,如果我們能夠推進這些事情,我認為這確實會改變公司的本質。隨著時間的推移,我在這個領域了解到,這就是獲得更多的成功和失敗,這是一種平衡。

  • It's been a journey for me personally as a leader, but also I think for the organization as it's pivoted towards R&D. So too early to say, I guess, are we -- do we think we're there? I think we're not, but I do think we have more shots on goal that are better governed, that have better profiles and that we've improved our POS. And if we can turn that into readouts, then I think we'll be extremely well-positioned for the company and versus our peers. Okay, next question?

    身為領導者,這對我個人來說是一段旅程,但我認為對以研發為中心的組織來說也是一段旅程。所以我想現在說我們是否認為我們已經做到了還為時過早?我認為我們沒有,但我確實認為我們有更多的射門,這些射門得到了更好的管理,有更好的配置文件,並且我們已經改進了我們的 POS。如果我們能夠將其轉化為讀數,那麼我認為我們將在公司和同行中處於非常有利的位置。好吧,下一個問題?

  • Operator

    Operator

  • Thibault Boutherin, Morgan Stanley.

    蒂博·布瑟林,摩根士丹利。

  • Thibault Boutherin - Analyst

    Thibault Boutherin - Analyst

  • Just a couple of questions on radioligands. You in-licensed projects for GETNet. There is already a GETNet indication. So just wonder if you could comment on the positioning versus the standard of care and what you think you can achieve here?

    關於放射性配體的幾個問題。您為 GETNet 引入了許可項目。已經有 GETNet 指示。所以想知道您是否可以對定位與護理標準進行評論,以及您認為您可以在這裡實現什麼?

  • And second question still related to radioligands if you could comment more broadly on your ambitions here. You also invested in a joint venture with Orano Med. So if you could comment on is this kind of a one-off because you saw something specific here? Or is it a way for Sanofi maybe be more present in the oncology space in a targeted way? And also, if you could comment on anything regarding the supply chain for this, how it stand between you and your partner and your ambition on the space. Thank you.

    如果您可以在這裡更廣泛地評論您的抱負,第二個問題仍然與放射性配體有關。您也與歐安諾醫療投資了一家合資企業。那麼,您是否可以評論這是一次性的,因為您在這裡看到了一些具體的東西?還是賽諾菲有針對性地更多地涉足腫瘤領域的一種方式?另外,如果您可以評論有關供應鏈的任何內容,您和您的合作夥伴之間的關係以及您在該領域的雄心壯志。謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you, Houman, radioligand, is it a one-off? What trues to it? And what about supply chain? And maybe Brendan has a view on that, I don't know.

    好的。謝謝你,Houman,放射性配體,它是一次性的嗎?它的真實情況是什麼?那麼供應鏈呢?我不知道,也許布倫丹對此有看法。

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

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

  • Yeah. Thanks, Paul. I'll start and hand over to my great colleague, Brendan. So simple question, simple answer, the radioligand space has been validated by others with different modalities of treatment. We are extremely excited about developing innovative treatments for patients with large unmet medical needs. lead-212 is a particularly interesting modality as an alpha emitter that has both direct effects on tumors, but also in line with our adjacencies in immunoscience is a way of activating the immune response in tumors.

    是的。謝謝,保羅。我將開始並將工作移交給我偉大的同事布倫丹。如此簡單的問題,簡單的答案,放射性配體空間已被其他人以不同的治療方式驗證。我們對為大量未滿足醫療需求的患者開發創新療法感到非常興奮。 Lead-212 是一種特別有趣的方式,作為一種 α 發射體,它既對腫瘤有直接影響,又符合我們在免疫科學領域的相關知識,是一種激活腫瘤免疫反應的方法。

  • So it has a double punch again, a thing that is beginning to come through in our strategy in Sanofi. So we're excited by the modality, the lead-212. Investing in promising innovative drugs is at the core of our strategy. And I have to say we are increasingly focused on under-delivering and overperforming.

    因此,它再次具有雙重打擊,這在我們賽諾菲的策略中已經開始體現。因此,我們對領先 212 模式感到興奮。投資有前景的創新藥物是我們策略的核心。我不得不說,我們越來越關注交付不足和表現出色的問題。

  • And in this case, the way this is manifest is in GETNet, the lead-212 molecule that we've started looking at has really very promising data in this rare form of cancer that again fits onto our rare disease franchise. So the beauty of this opportunity is it knits together many of the areas in which we are -- we have the right to play and offer superior clinical benefits as well as limiting damage to adjacencies to these GETNets and other tumors. With respect to supply chain, Brendan, I wonder whether you can help.

    在這種情況下,這一點在 GETNet 中得到了體現,我們開始研究的先導 212 分子在這種罕見的癌症中擁有非常有希望的數據,這再次適合我們的罕見疾病系列。因此,這個機會的美妙之處在於它將我們所處的許多領域結合在一起——我們有權參與並提供卓越的臨床效益,並限制對這些 GETNet 和其他腫瘤鄰近區域的損害。關於供應鏈,Brendan,我想知道你是否可以提供幫助。

  • Brendan O' Callaghan - Executive Vice President - Global Manufacturing and Supply, Member of the Executive Committee

    Brendan O' Callaghan - Executive Vice President - Global Manufacturing and Supply, Member of the Executive Committee

  • Sure. So yeah, getting treatment to patients in a timely, efficient manner, obviously is paramount. And in that regard, we're working with Orano Med, who are true experts in this space, and we're quite confident in our ability to meet the supply requirements.

    當然。所以,及時、有效地為患者提供治療顯然是至關重要的。在這方面,我們正在與 Orano Med 合作,他們是這個領域的真正專家,我們對滿足供應要求的能力非常有信心。

  • We have ample quantities of the base isotoptorium-232 available, which we've covered multiple, multiple years and the process from which we then extract the isotope interest, which is lead-212 does not -- it's a very robust chemical process does not rely on nuclear reactors or practical accelerators or any complex technology like that.

    我們有大量可用的基礎 isotoptorium-232,我們已經研究了很多年,然後我們從中提取感興趣的同位素的過程,而鉛 212 則沒有——這是一個非常強大的化學過程,沒有依賴核反應器或實用加速器或任何類似的複雜技術。

  • So we're quite confident in their ability to secure seemless supply chain. We're building specialist alpha therapy labs close to the points of treatment, close to major distribution hubs, which will allow us to secure the availability of product within the timelines that are required for treatment. So in summary, we're very, very confident in Orano Med and the provisions they're putting in place.

    因此,我們對他們確保無縫供應鏈的能力充滿信心。我們正在靠近治療點和主要分銷中心的地方建立專業的阿爾法治療實驗室,這將使我們能夠確保在治療所需的時間內提供產品。總而言之,我們對歐安諾醫療及其製定的規定非常非常有信心。

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

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

  • Just one other comment, Brendan. One of the things we're incredibly proud of is the ability to leverage talent and technology in France, which is a unique differentiator we have and the ability to work with a French leader in nuclear technology is something that is uniquely available to us at Sanofi. We're very proud to be working with this partner.

    只是另一則評論,布倫丹。我們非常自豪的一件事是能夠利用法國的人才和技術,這是我們獨特的優勢,而與法國核子技術領導者合作的能力是我們賽諾菲獨有的。我們非常自豪能夠與這個合作夥伴合作。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Yeah, I think the last one because it was asked, but about supply, I think it's sort of notice, isn't it, that it's one of the more difficult things to do because they're all advances, frankly. So hopefully, we can take advantage of that with the technical capability too.

    是的,我認為最後一個是因為有人問過,但關於供應,我認為這是一種通知,不是嗎,這是更難做的事情之一,因為坦率地說,它們都是進步。所以希望我們也可以利用技術能力來利用這一點。

  • Operator

    Operator

  • Simon Baker, Redburn.

    西蒙貝克,雷德伯恩。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Two if I may, please. Firstly, on Beyfortus. Could you just remind us where we currently or where you currently are with capacity and how that will evolve in '25 and '26. And then the second question, going back to Opella, I wanted to ask about the influence that BPI France will have, specifically, any influence they have beyond the one board seat.

    如果可以的話,請給我兩個。首先,關於貝福特斯。您能否提醒我們目前或您目前的產能情況以及 25 和 26 年將如何發展。然後第二個問題,回到 Opella,我想問 BPI France 將產生的影響力,特別是他們除了一個董事會席位之外的影響力。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you, Simon. Beyfortus capacity.

    好的。謝謝你,西蒙。貝弗特斯容量。

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • Great. There has been a lot of work that has been done by our manufacturing partners and all stakeholders involved. As you know very well, we've added two filling lines up and running, and we're going full speed. So with the 20 markets we've just launched in 2024, we don't see any capacity limitation and we'll grow that supply for next year and the year after to make sure that there will be, again, no supply constraints anticipated at all in '25, '26.

    偉大的。我們的製造合作夥伴和所有相關利益相關者已經做了很多工作。如您所知,我們已經增加了兩條填充線並正在運行,並且我們正在全速運轉。因此,對於我們在 2024 年剛推出的 20 個市場,我們沒有看到任何產能限制,我們將增加明年和後年的供應,以確保預計不會出現供應限制。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you. François?

    好的。謝謝。弗朗索瓦?

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • On the BPI side, the fact that BPI is joining us show the attractiveness of the business case as far as Opella is concerned. Typically, I mean, when you have 1% to 2% shareholding in the company, I mean the governance attached to it is relatively limited. So this is a classical -- this is what happens in that class. It's in line with market prices for a stake of around 1% to 2%.

    在 BPI 方面,BPI 加入我們的事實表明了商業案例對 Opella 的吸引力。通常,我的意思是,當你擁有公司 1% 到 2% 的股權時,我的意思是與之相關的治理相對有限。所以這是一個經典——這就是那堂課上發生的事情。約1%至2%的股權與市場價格一致。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉,TD·考恩。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Does Sanofi have any efficacy data for Beyfortus, which supports protection through six months and what percent of RSV cases fall between five and six months. This would appear to be one advantage that Merck may indeed have. And then second, is Sanofi on track to initiate Phase 3 trials for its 21 valent pneumococcal vaccine this year? And is it still commercially viable given the competitor's 31 valent data?

    賽諾菲是否有 Beyfortus 的任何療效數據,該數據支持六個月的保護以及 RSV 病例在五到六個月之間的百分比。這似乎是默克確實擁有的優勢之一。其次,賽諾菲今年是否有望啟動 21 價肺炎鏈球菌疫苗的 3 期試驗?考慮到競爭對手的 31 價數據,它在商業上是否仍然可行?

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Steve. Excellent questions. Thomas, on durability?

    謝謝你,史蒂夫。很好的問題。托馬斯,關於耐用性?

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • It's a great question. First of all, do we have data over six months? Absolutely, and we made the reference in a slide that is today into this presentation. We've just made this data published and they are available. And as you will see, what's very nice with this data is that there is no winning efficacy after six months.

    這是一個很好的問題。首先,我們有超過六個月的數據嗎?當然,我們在今天的簡報中的幻燈片中引用了這一點。我們剛剛發布了這些數據並且可以使用。正如您將看到的,該數據的優點是六個月後沒有獲勝功效。

  • We still see 83% efficacy against hospitalization after six full months and we are very confident. But we have kept running for another data point after that, the efficacy will still go very well. So I actually believe that duration of protection is significantly in favor of Beyfortus compared to Iscalimab, which I would recommend to look at a couple of points.

    六個月後,我們仍然看到 83% 的住院療效,我們對此非常有信心。但之後我們一直在跑另一個數據點,效果還是會很好。因此,我實際上認為,與 Iscalimab 相比,Beyfortus 的保護持續時間明顯有利於 Iscalimab,我建議您考慮以下幾點。

  • I would suggest that people look at the available data that are into the half-life of both products where you see a significant difference. One is above 40 days. The other one is about 70 days, so a significant difference between both products.

    我建議人們查看兩種產品半衰期的可用數據,您會發現顯著差異。1個是40天以上。另一種約為70天,因此兩種產品之間存在顯著差異。

  • And I remind everyone that for the coming ACIP discussions, our competitor, we need to show the Kaplan-Meier's curves of their Phase 3 efficacy data that we show what is the number of new cases and the associate protections in the month of fourth month, fifth month, and six months which will be very different, we believe, than what we have observed with Beyfortus because we believe most of the cases in our competitors' Phase 3 we're in the very early phases. So I do believe that duration is going to be a very important point to look at in the coming periods.

    我提醒大家,對於即將到來的 ACIP 討論,我們的競爭對手,我們需要展示他們的第三階段療效數據的 Kaplan-Meier 曲線,我們顯示第四個月的新病例數和相關保護,我們相信,第五個月和六個月將與我們在Beyfortus 觀察到的情況非常不同,因為我們相信競爭對手第三階段的大多數案例都處於非常早期的階段。因此,我確實相信,持續時間將成為未來一段時間需要關注的一個非常重要的點。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you and pneumococcal.

    謝謝你和肺炎球菌。

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • And on PCV21, thank you very much because it's a very important product for our pediatric portfolio. We are fully on track to start Phase 3 in 2024. I confirm that and the next part of your question was, is it a variable product? Absolutely. And you fully understand that our goal is not just to do a PCV21 stop, and that's it. Our goal is to have the first ever pediatric pneumococcal vaccines product with more than 20 variants available on the marketplace. And from that first base, that would already be the first milestone, then we will be further with additional cell types. So we will -- once you're in that race, you always want to remain competitive.

    對於 PCV21,非常感謝,因為它是我們兒科產品組合中非常重要的產品。我們完全預計在 2024 年啟動第三階段。我確認這一點,您問題的下一部分是,它是可變產品嗎?絕對地。你們完全明白,我們的目標不僅僅是停止 PCV21,僅此而已。我們的目標是在市場上推出首款擁有 20 多種變體的兒科肺炎球菌疫苗產品。從第一個基礎開始,這已經是第一個里程碑,然後我們將進一步研究其他細胞類型。所以我們會——一旦你參加了比賽,你總是想保持競爭力。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you. Very clear. Next question?

    謝謝。非常清楚。下一個問題?

  • Operator

    Operator

  • David Risinger, Leerink.

    大衛瑞辛格,李林克。

  • David Risinger - Analyst

    David Risinger - Analyst

  • So congrats on the financial results. I have two questions. First, regarding Amgen's OX40 Phase 3 efficacy, since it was lower than expected, did the weak efficacy results impact your expectations for forthcoming amlitelimab efficacy? And then sorry about the noise. Second, Sanofi has several I&I pipeline readouts over the next year. Could you please provide a framework on how the company plans to disclose the slew of results that are coming, including four Phase 2 data readouts, which will be important proof of concepts?

    因此,恭喜財務業績。我有兩個問題。首先,關於安進公司的OX40 3期療效,由於其低於預期,較弱的療效結果是否影響了您對即將推出的amlitelimab療效的預期?然後對噪音感到抱歉。其次,賽諾菲在明年有幾項 I&I 管線數據。您能否提供一個框架,說明該公司計劃如何披露即將到來的一系列結果,包括四個第二階段數據讀數,這將是重要的概念證明?

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you, David. So comments coming on OX40 ligand and the sort of the results from Amgen.

    好的。謝謝你,大衛。關於 OX40 配體的評論以及安進的結果。

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • Yeah. So thank you so much for the question. We remain very excited about the OX40 pathway in general. We were very detailed in our credential in this target before we went into the space and all the publicly available data to support an even stronger perspective on the importance of the OX40 pathway. However, the differentiation of the OX40 receptor versus the ligand may be manifest in the data that's come from Amgen.

    是的。非常感謝你提出這個問題。總的來說,我們對 OX40 通路仍然非常興奮。在進入該領域之前,我們非常詳細地介紹了該目標的憑證以及所有公開數據,以支持對 OX40 途徑重要性的更強有力的看法。然而,OX40 受體與配體的差異可能在來自安進的數據中很明顯。

  • What I'm confident in being able to say is that targeting the ligand with its impact on not diluting T-cells, but retaining them may well and is likely to translate in greater durability and higher efficacy. But also, it's now very clear that the side effect profile of the ligand is much better than the receptor. But to give you a very simple and clear summary, we think the presence of another molecule, the tide raises your boat.

    我有信心能夠說的是,靶向配體及其對不稀釋 T 細胞的影響,但保留它們很可能會轉化為更大的耐久性和更高的功效。而且,現在非常清楚的是,配體的副作用比受體好得多。但為了給你一個非常簡單和清晰的總結,我們認為另一種分子的存在,潮水會抬高你的船。

  • It's great to have other players in atopic dermatitis space because it allows a much greater education of the population and a greater biopeneration. However I think targeting the ligand has now been shown to be a better, more effective intervention. And extremely quickly to your second question, you are right, we are blessed to have a number of very significant readouts coming out in the next year.

    異位性皮膚炎領域有其他參與者真是太好了,因為它可以讓人們接受更多的教育並實現更大的生物開放。然而,我認為靶向配體現在已被證明是更好、更有效的干預措施。非常快速地回答你的第二個問題,你是對的,我們很幸運能夠在明年發布一些非常重要的讀數。

  • We will focus on presenting and disclosing our results in the appropriate form, most of which will be in the scientific congresses. We are, however, deeply conscious of our compliance responsibilities and our responsibilities to the street. And if they are material, of course, we will hasten to convey them to the street as quickly as possible.

    我們將專注於以適當的形式展示和揭露我們的成果,其中大部分將在科學大會上進行。然而,我們深刻意識到我們的合規責任和對街道的責任。如果它們是物質的,我們當然會盡快將它們運送到街上。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you. Next question?

    好的。謝謝。下一個問題?

  • Operator

    Operator

  • Richard Parkes, BNP Exane.

    理查德‧帕克斯 (Richard Parkes),法國巴黎銀行 Exane。

  • Richard Parkes - Analyst

    Richard Parkes - Analyst

  • Hi. Thanks very much for taking my questions. Just coming back to Beyfortus and expectations into 2025, I wondered if we could just push you a little bit more on that. If in the worst case competition does materialize just wondering whether you would be willing to commit to still being able to grow the franchise even with or without competition, maybe through international launches?

    你好。非常感謝您回答我的問題。回到 Beyfortus 以及對 2025 年的期望,我想知道我們是否可以在這方面進一步推動您一點。如果在最壞的情況下競爭確實發生,只是想知道您是否願意承諾即使有或沒有競爭仍然能夠發展特許經營權,也許透過國際發布?

  • And then related to that, I think, at the Vaccine Day a couple of years ago, you put a slide implying RSV infant market forecast of [2.4 billion] by 2030.I'm sure your thinking has evolved since then. So could you just update us on your current thinking over the total commercial potential? Thank you.

    與此相關的是,我認為,在幾年前的疫苗日上,您放了一張幻燈片,暗示到2030 年RSV 嬰兒市場預測將達到[24 億]。已經發生了變化。那麼您能否向我們介紹一下您目前對整體商業潛力的想法?謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you for that, Richard. So Beyfortus market, how's it going to develop?

    好的。謝謝你,理查。那麼Beyfortus市場,會如何發展呢?

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • No significant change on our RSV overall market anticipation for 2030. You also noticed though that on top of the RSV newborn, there will be the RSV infant RF. The so-called RSV total vaccines coming down the road for kids to be protected at age one and above. So that will, of course, be a very interesting part for us.

    我們對 2030 年 RSV 整體市場預期沒有重大變化。您也注意到,在 RSV 新生兒之上,也會有 RSV 嬰兒 RF。所謂的 RSV 全面疫苗即將上市,為一歲及以上兒童提供保護。當然,這對我們來說是非常有趣的部分。

  • But back to the initial part of your question, on the 2025 outlook and what's the outlook with or without competitor, let me be very clear because I might have missed it in the first time. But with or without competitors, 2025 will be a year of growth for Beyfortus.

    但回到你問題的最初部分,關於 2025 年的前景,以及有或沒有競爭對手的前景如何,讓我說得非常清楚,因為我可能一開始就錯過了。但無論有沒有競爭對手,2025 年都將是 Beyfortus 成長的一年。

  • Again, there is a significant number of newborns that do require RSV protections. We believe that it's not reasonable, and it's totally unfair from an ethical perspective to make sure that there is a RSV protection for some baby and not for some others.

    同樣,有大量新生兒確實需要 RSV 保護。我們認為,確保某些嬰兒受到 RSV 保護而不是其他嬰兒受到 RSV 保護是不合理的,從道德角度來看也是完全不公平的。

  • That's why we're 100% on all infant protection. All infant protection can only be provided by monoclonal antibodies and not maternal immunization. That's why it's very good to have further voices pushing on all infant protection. The playing field will increase with or without the competitor and therefore with or without the competitor Beyfortus will move in 2025.

    這就是為什麼我們 100% 提供所有嬰兒保護。所有嬰兒保護只能透過單株抗體提供,而不能透過母體免疫提供。這就是為什麼有更多的聲音推動所有嬰兒保護是非常好的。無論有沒有競爭對手,競爭環境都會擴大,因此無論有沒有競爭對手,Beyfortus 都將在 2025 年發生變化。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, and thanks, Richard for going back and looking at that deck. It was a good deck with other nuggets in there about how things would develop. We should probably take another look at that too. Okay, next question, please.

    謝謝你,也謝謝理查德,謝謝你回頭看那套牌。這是一個很好的套牌,裡面有其他關於事情將如何發展的金塊。我們或許也應該重新檢視一下這一點。好的,請下一個問題。

  • Operator

    Operator

  • Rajesh Kumar, HSBC.

    拉傑什·庫馬爾,匯豐銀行。

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • Another one on Beyfortus versus Clesrovimab. When one of the points which Merck are making is the stocking up is much easier if the dose is body weight not dependent on the body weight. So how do you help the providers with stocking up of inventory for different body weight infants and how can you ensure that doesn't become a significant disadvantage for you?

    另一篇關於 Beyfortus 與 Clesrovimab 的對比。默克公司提出的觀點之一是,如果劑量是根據體重而不取決於體重,那麼備貨就會容易得多。那麼,您如何幫助供應商為不同體重的嬰兒儲備庫存,以及如何確保這不會成為您的重大劣勢?

  • Obviously, efficacy and all the data points you've made are well-noted. So -- but this aspect of practical ordering might be helpful to understand. And just a clarification on Opella, can you just run through in terms of the cash proceeds you've guided to that's after tax or before tax? Thank you.

    顯然,功效和您所做的所有數據點都得到了充分關注。所以——但是實際排序的這個方面可能有助於理解。請澄清一下奧佩拉,您能否簡單介紹一下您所指導的稅後或稅前現金收益?謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thanks, Rajesh. Beyfortus stocking.

    好的。謝謝,拉傑什。Beyfortus 長襪。

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • Yeah. So the matter on those, I'm coming back to that in a second, Rajesh. But as you started to add in your question, indeed, it's two monoclonal antibodies, both targeting RSV, but there are significant differences. I think in the coming ACIP meeting will be very interesting to highlight those. First and foremost, Beyfortus has demonstrated RSV protection in the real world and has been studied in more than 75,000 infants. That's a very significant number of kids, showing a very high bar of efficacy.

    是的。關於這些問題,我稍後會回到這個主題,拉傑什。但正如您開始在問題中添加的那樣,確實,這是兩種單株抗體,都針對 RSV,但有顯著差異。我認為在即將舉行的 ACIP 會議上強調這些將會非常有趣。首先也是最重要的是,Beyfortus 已在現實世界中展示了 RSV 保護作用,並已在超過 75,000 名嬰兒身上進行了研究。這是一個非常多的孩子,顯示出非常高的功效標準。

  • Second of all, when you look specifically at the efficacy for the primary endpoint against RSV, medically attended LRT disease with the usual caveat, of course, that when you have when you're comparing across trials, you've seen that Beyfortus has shown a higher efficacy estimated point around 75% versus Clesrovimab at 60%.

    其次,當您專門研究主要終點針對 RSV、就醫 LRT 疾病的療效時,當然,通常需要注意的是,當您比較不同試驗時,您會發現 Beyfortus 已顯示出與Clesrovimab 的60% 相比,療效估計值更高,約75%。

  • I do believe it's important because while we absolutely want to make sure that we prevent hospitalization, one of the most severe outcomes, we also want to make sure and I'm sure parents want to make sure that they can increase their chance of not missing one, two or three days of work in order to have to bring their newborn at multiple doctor visits.

    我確實相信這很重要,因為雖然我們絕對希望確保防止住院,這是最嚴重的後果之一,但我們也想確保並且我確信父母希望確保他們可以增加不缺席的機會為了帶著新生兒多次去看醫生,他們需要工作一、兩天或三天。

  • So I think that we had with Beyfortus a product that has shown high efficacy against both severe and less severe outcomes. And finally, the safety profile is a very important point. This is the newborn population, but the most fragile part of the population, and we've shown a pristine safety profile year on year and a very high duration with 180 days.

    所以我認為我們的 Beyfortus 產品對嚴重和不太嚴重的結果都顯示出高效能。最後,安全性是非常重要的一點。這是新生兒群體,但卻是群體中最脆弱的部分,我們逐年展現原始的安全狀況,持續時間非常長,達到 180 天。

  • Now back to your question, does that mean that the dosage on Clesrovimab is a significant differentiator? Actually, we don't think this is an issue at all. First of all, because we've thought a lot about this. Adding two doses or two dosages, should I say, is important because the right dose is fitting the right channel.

    現在回到您的問題,這是否意味著 Clesrovimab 的劑量是一個顯著的差異因素?事實上,我們認為這根本不是一個問題。首先,因為我們對此考慮了很多。我應該說,添加兩個劑量或兩個劑量很重要,因為正確的劑量適合正確的通道。

  • The smallest babies typically at newborn time are weighing less than 5 kilograms, they should receive a 50 milligram dose. These babies usually do get doses in the hospital channel or within a maternity setting. On the other hand, babies that are weighing more than 5 kilograms should receive a 100 milligram dose, which are normally older babies, but getting within the pediatrician clinic setups. So each channel has a very well corresponding specific dosage that goes very well.

    最小的嬰兒在新生兒時通常體重不到 5 公斤,他們應該接受 50 毫克的劑量。這些嬰兒通常會在醫院渠道或產科環境中接受疫苗接種。另一方面,體重超過 5 公斤的嬰兒應接受 100 毫克的劑量,這些嬰兒通常是較大的嬰兒,但屬於兒科醫生診所的範圍。所以每個渠道都有一個非常對應的特定劑量,效果非常好。

  • And finally, on the dosage point, I think it's going to be very interesting for doctors to see that our findings in clinical studies is that 50 milligram doses for our product for new born is exactly the right choice as it delivers the best efficacy with the smallest possible dose for newborn babies. I think we have good arguments on those point too.

    最後,在劑量方面,我認為醫生會非常感興趣,因為我們在臨床研究中的發現表明,我們的產品用於新生兒的 50 毫克劑量正是正確的選擇,因為它可以提供最佳功效新生兒盡可能最小的劑量。我認為我們在這一點上也有很好的論點。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you very much. François?

    非常感謝。弗朗索瓦?

  • Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

    Francois-Xavier Roger - Chief Financial Officer, Member of the Executive Committee

  • Yeah. On the tax -- on the amount of cash that we will receive at the earliest in Q2 2025 for Opella, we confirm it's a high-single-digit number in billions of euros net of tax, net of any other cost, such as transaction costs as well. So this is really a net tax possibly that we will get at the earliest in Q2.

    是的。關於稅收——我們最早將在 2025 年第二季度收到 Opella 的現金金額,我們確認這是一個高個位數的數字,扣除稅金、扣除交易等任何其他成本後,達到數十億歐元。也是如此。因此,這實際上是我們最早可能在第二季度獲得的淨稅。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you. I think we have two questions left. I think Eric or Florent. So over to the next question.

    謝謝。我想我們還有兩個問題。我認為埃里克或弗洛倫特。那麼進入下一個問題。

  • Operator

    Operator

  • Eric Le Berrigaud, Stifel.

    埃里克·勒貝里戈,斯蒂菲爾。

  • Eric Le Berrigaud - Analyst

    Eric Le Berrigaud - Analyst

  • First, in recent interactions with investors, it looks like there's a topic that comes through more often around Dupixent LOE extension. I'm unclear whether it comes from you, from your partner or from any other source, but maybe you can update us on where you stand about extending LOE of Dupixent?

    首先,在最近與投資者的互動中,似乎有一個更頻繁地圍繞著 Dupixent LOE 擴展的話題出現。我不清楚它是來自您、您的合作夥伴還是任何其他來源,但也許您可以向我們介紹您對於擴展 Dupixent LOE 的立場?

  • And the second question, maybe I missed it, but I don't see any update into your pipeline agenda about the anti-TL1A. Do you expect this to come from Teva or what can you -- when can we expect some Phase 2 update on that specific assets? Thank you.

    第二個問題,也許我錯過了,但我沒有看到你們關於抗 TL1A 的管道議程有任何更新。您是否期望梯瓦公司(Teva)提供此資訊?謝謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you. Roy, over to you on Dupi loss of exclusivity.

    好的。謝謝。羅伊,關於杜皮失去排他性的問題就交給你了。

  • Roy Papatheodorou - Executive Vice President, General Counsel, Member of the Executive Committee

    Roy Papatheodorou - Executive Vice President, General Counsel, Member of the Executive Committee

  • Sure. The Dupixent compound partner expires in the US in March 2031. This is the patent term extended expiration date. In Europe, it's March 2033, which is the SPC extended expiration date with pediatric exclusivity, which is in the process of being granted across EU member states.

    當然。Dupixent 化合物合作夥伴在美國將於 2031 年 3 月到期。這是專利期限延長的到期日。在歐洲,現在是 2033 年 3 月,這是 SPC 延長兒科特許經營權有效期的日期,歐盟成員國正在批准該特許經營權。

  • We are referring to these compound patent expiration dates as the LOE dates. On top of that, in both the US and Europe, there's further patent and patent applications covering inventions related to Dupixent which have expiration dates ranging from [33 to 44]. It is too early to speculate on later LOE dates for Dupixent at this stage.

    我們將這些化合物專利到期日稱為 LOE 日期。除此之外,在美國和歐洲,還有更多涉及 Dupixent 相關發明的專利和專利申請,其有效期限為[33至44]。現階段推測 Dupixent 的後續 LOE 日期還為時過早。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you, Roy. And our strategies are internal because, of course, lots of people are interested in which way we decide to go. Okay and then Houman on anti-TL1A.

    好的。謝謝你,羅伊。我們的策略是內在的,因為當然,很多人對我們決定走哪條路感興趣。好的,然後 Houman 就抗 TL1A 進行治療。

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

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

  • Briefly, thanks for the question. As you've seen in the deck Duvakitug as it's now known and anti-TL1A reads out in H2 2024, you should expect a comment from our partner Teva and ourselves later this year or early next year and we'll be very excited to share that with you when we see the data.

    簡而言之,謝謝你的提問。正如您在Duvakitug 套牌中所看到的那樣,它現在已為人所知,並且抗TL1A 將於2024 年下半年讀出,您應該期待我們的合作夥伴Teva 和我們自己在今年晚些時候或明年初發表評論,我們將非常高興與您分享當我們看到數據時,與您一起。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Thank you. And I think it may be the last question from Florent.

    好的。謝謝。我認為這可能是弗洛朗的最後一個問題。

  • Operator

    Operator

  • Florent Cespedes, Bernstein.

    佛羅倫特·塞斯佩德斯、伯恩斯坦。

  • Florent Cespedes - Analyst

    Florent Cespedes - Analyst

  • Good afternoon. Florent Cespedes from Bernstein. Two quick questions, please. First, for Houman on hidradenitis suppurativa. In fact, next year, first half, you will have three Phase 2 trials readout on this -- for this indication with three different mechanism of action.

    午安.伯恩斯坦的弗洛倫特·塞斯佩德斯。請簡單問兩個問題。首先,對侯曼來說,化膿性汗腺炎。事實上,明年上半年,您將看到關於此的三個二期試驗的讀數——針對該適應症有三種不同的作用機制。

  • I was just wondering if you could give us a little bit more color on your strategy on this population as you have already products on the market are quite successful. So some thoughts on this would be great and notably also in terms of potential of this market? And my second question is for Thomas. It's a follow-up on Beyfortus.

    我只是想知道您是否可以給我們更多關於您針對這一人群的策略的信息,因為您在市場上的產品已經相當成功。那麼對此的一些想法會很棒,特別是在這個市場的潛力方面?我的第二個問題是問湯瑪斯的。這是 Beyfortus 的後續作品。

  • I was just wondering if we could have a little bit more color about manufacturing capacities for 2025. Is there a third manufacturing line that will be ready next year? And when you mentioned, Thomas, that there will be growth in 2025, I was just wondering if you could give us a little bit more color on this [if you can quantify this]. Many thanks.

    我只是想知道我們是否可以對 2025 年的製造能力有更多的了解。明年是否有第三條生產線準備就緒?托馬斯,當您提到 2025 年將會出現增長時,我只是想知道您能否給我們更多關於這一點的信息[如果你能量化這一點]。非常感謝。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Florent. HS, Houman, and Brian if you have any comment that certainly you can start with.

    謝謝你,弗洛倫特。HS、Houman 和 Brian,如果您有任何意見,當然可以開始。

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

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

  • Yeah. Florent, thanks for the question. Thank you for focusing the lens on HS, which is a highly unmet medical need, highly heterogeneous condition with multiple stages of that. The early stage being inflammatory and later on having multiple fistulas disease with requiring surgical debridement.

    是的。弗洛倫特,謝謝你的提問。感謝您將鏡頭聚焦在 HS 上,這是一種高度未滿足的醫療需求,具有高度異質性且具有多個階段。早期是炎症,後來出現多發性瘻管疾病,需手術清創。

  • It's a complicated disorder with substantial stratification. And as you know, I was involved with the first-generation molecules in HS. HS really does exemplify our strategy very clearly. Firstly, we are committed to franchises rather than individual molecules.

    這是一種複雜的疾病,具有顯著的分層。如你所知,我參與了 HS 中第一代分子的研究。HS 確實非常清楚地體現了我們的策略。首先,我們致力於特許經營而不是單一分子。

  • We want to serve our patients and the physicians in all stages and grades of disease. In this case, we used a well-credentialed target of OX40 ligand in this situation as part of our signal seeking lifecycle management strategy with amlitelimab.

    我們希望為疾病各個階段和級別的患者和醫生提供服務。在這種情況下,我們在這種情況下使用了經過充分認證的 OX40 配體靶標,作為我們使用 amlitelimab 進行訊號尋求生命週期管理策略的一部分。

  • We have always said that we want to go and buy a better by understanding the targets more clearly and leveraging our internal technologies here, combining TNF, highly validated and OX40 ligand which is preclinically credential, putting those together using our own Ablynx technology, it is a nanobody technology gives us an opportunity to serve patients with a BioBetter as well as the anti-TNF, which is already on the market and amlitelimab. And then moving one step forward, we've always expressed a view that as well as antibodies, we'd like to provide optionality for patients with small molecule.

    我們一直說,我們希望透過更清楚地了解目標並利用我們的內部技術來購買更好的藥物,將TNF、經過高度驗證的和具有臨床前資格的OX40 配體結合起來,使用我們自己的Ablynx 技術將它們組合在一起,這是奈米抗體技術使我們有機會為患者提供 BioBetter 以及已經上市的抗 TNF 藥物和 amlitelimab。然後向前邁出一步,我們一直表達一種觀點,即除了抗體之外,我們還希望為患者提供小分子的選擇。

  • That's why IRAK4 Degrader which we work very closely with our partner gives us further optionality in the space and we look forward to seeing what the data in the space shows. So when we think about HS, we think about franchises, we think about stratification, and we think about optionality to ensure that we serve the whole strata of every finishing.

    這就是為什麼我們與合作夥伴密切合作的 IRAK4 Degrader 為我們提供了該領域的更多選擇,我們期待看到該領域的數據所顯示的內容。因此,當我們考慮 HS 時,我們會想到特許經營權,我們會考慮分層,我們會考慮可選性,以確保我們為每個完成的整個階層提供服務。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Okay. Great. Thank you very much. I think on Beyfortus.

    好的。偉大的。非常感謝。我想到了貝弗特斯。

  • Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

    Thomas Triomphe - Executive Vice President - Vaccines, Member of the Executive Committee

  • On Beyfortus capacity, Florent, as you know very well, we are shooting and we've communicated this to triple capacity in 2024 and we've done that. So you were talking about third line. Let me be very clear. We have already started to release and distribute Beyfortus from the third line as we speak already.

    關於 Beyfortus 的容量,Florent,正如您所知道的那樣,我們正在努力,我們已經傳達了這一點,將在 2024 年將容量增加到三倍,我們已經做到了。所以你說的是第三線。讓我說得很清楚。正如我們所說,我們已經開始從第三行開始發布和分發 Beyfortus。

  • So this is already installed and that's why I'm very confident that there is no supply challenges that I can foresee in terms of constraints for '25 and beyond. In addition, I think you are going back to the growth in 2025, a bit too early to give you some sort of color on this.

    所以這已經安裝好了,這就是為什麼我非常有信心,我可以預見到 25 年及以後的限制不會出現供應挑戰。此外,我認為您將在 2025 年恢復成長,現在對此提供一些資訊還為時過早。

  • As you know very well, when it comes to immunization schedule, first, there needs to be recommendation set up by the new countries in which we're going to launch and then we'll be able to see more clearly the overall landscape we have for 2025. Where I do see growth coming down the road is North America increase, I would say, penetration of antibodies, but also an increase of Beyfortus in Europe and in the international zones with more countries we're going to launch into.

    大家都知道,在免疫接種計劃方面,首先需要我們要推出的新國家提出建議,然後我們才能更清楚地看到我們的整體情況。我確實看到北美的成長是抗體滲透率的成長,而 Beyfortus 在歐洲和國際地區的成長,我們將在更多國家推出。

  • Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

    Paul Hudson - Chief Executive Officer, Executive Director, Member of the Executive Committee

  • Thank you, Thomas. Well, thanks for that, the last question. Our strong business momentum continued in the third quarter with an estimated underlying 11% growth at CER. We continued to execute on our launches. We kept advancing our pipeline of new medicines and we recently upgraded our 2024 EPS guidance. I'm pleased with our progress in becoming a pure play and science-focused biopharma company committed to serving patients and accelerating growth. And thanks to all of you for your interest in Sanofi.

    謝謝你,托馬斯。嗯,謝謝你,最後一個問題。我們第三季持續保持強勁的業務勢頭,以固定匯率計算,預計基本成長 11%。我們繼續執行我們的發布。我們不斷推進新藥研發,最近也升級了 2024 年 EPS 指引。我對我們在成為一家專注於科學、致力於服務患者和加速成長的生物製藥公司方面取得的進展感到高興。感謝大家對賽諾菲的關注。