Novartis AG (NVS) 2025 Q4 法說會逐字稿

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  • Operator

    Operator

  • Good morning and good afternoon and welcome to the Novartis Q4 full-year 2025 results release conference call and live webcast. (Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.

    早安、下午好,歡迎參加諾華2025年第四季全年業績發布電話會議及網路直播。(操作員說明)電話會議的錄音,包括問答環節,將在會議結束後不久發佈在我們的網站上。

  • With that, I would like to hand over to Ms. Sloan Simpson, Head of Investor Relations. Please go ahead, madam.

    接下來,我將把發言權交給投資人關係主管史隆辛普森女士。請便,女士。

  • Sloan Simpson - Global Head of Investor Relations

    Sloan Simpson - Global Head of Investor Relations

  • Thank you, Sarah. Good morning and good afternoon, everyone, and welcome to our Q4 2025 earnings call. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Please refer to the company's Form 20-F on file with the US Securities and Exchange Commission for a description of some of these factors.

    謝謝你,莎拉。各位早安/下午好,歡迎參加我們2025年第四季財報電話會議。今天發布的資訊包含前瞻性陳述,涉及已知和未知的風險、不確定性及其他因素。這些因素可能導致實際結果與此類聲明中明示或暗示的任何未來結果、業績或成就有重大差異。有關其中一些因素的說明,請參閱本公司向美國證券交易委員會提交的 20-F 表格。

  • The discussion today is not a solicitation of a proxy nor an offer of any kind with respect to the securities of Avidity Biosciences or SpinCo. The parties have filed relevant documents with the US SEC, including a proxy statement for the transactions and a registration statement for the spin-off. We urge you to read these materials that contain important information when they become available.

    今天的討論並非徵求代理權,也不是對 Avidity Biosciences 或 SpinCo 的證券的任何形式的要約。雙方已向美國證券交易委員會提交相關文件,包括交易委託書和分拆註冊聲明。我們強烈建議您在這些資料發布後仔細閱讀,其中包含重要資訊。

  • Before we get started, I also want to remind our analysts to please limit yourselves to one question at a time, and we'll cycle through the queue as needed. And with that, I will hand over to Vas.

    在正式開始之前,我還想提醒各位分析師,請每次只提一個問題,我們會根據需要輪流提問。接下來,我將把麥克風交給瓦斯。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Terrific. Thank you, Sloan, and great to be with everyone today. With me in the room are Harry Kirsch, our Chief Financial Officer; and Mukul Mehta, our Chief Financial Officer Designate, who will be taking over for Harry in mid-March.

    了不起。謝謝你,斯隆,今天很高興能和大家在一起。與我同在房間裡的還有我們的財務長哈里·基爾施;以及我們的候任首席財務官穆庫爾·梅塔,他將於三月中旬接替哈里的職位。

  • So let's dive into the results and when we start on slide 5, Novartis delivered high single-digit growth as you saw earlier this morning, and importantly, we achieved our 40% core margin goal two years ahead of plan, and I think that demonstrates the strong operational performance of the company.

    那麼讓我們深入探討一下結果。從第 5 張投影片開始,正如您今天早上看到的,諾華實現了高個位數成長,更重要的是,我們提前兩年實現了 40% 的核心利潤率目標,我認為這證明了公司強勁的營運業績。

  • On the full year, our sales were up 8%, Core OpInc was up 14%. As I mentioned, the 40.1% core margin at $21.9 billion now on Core OpInc, I think, significant growth over the years. On quarter four, sales did decline, impacted by both the gross to nets, which we'll talk about a bit more as well as the, Entresto LOE and Core OpInc is up 1%.

    全年來看,我們的銷售額成長了 8%,Core OpInc 成長了 14%。正如我之前提到的,Core OpInc 目前的核心利潤率為 40.1%,營收為 219 億美元,我認為這是多年來的顯著增長。第四季度,銷售額確實下降了,這不僅受到毛利與淨利比率的影響(我們稍後會詳細討論),也受到 Entresto LOE 和 Core OpInc 成長 1% 的影響。

  • We did have some important pipeline highlights which we'll cover over the course of the call, but I think a few I wanted to highlight up front. First, Remibrutinib, we achieved the submission in the most common type of CIndU that was based on positive Phase 3 results as well as interactions with the FDA, and we'll have the remaining readouts for the two other subtypes of chronic inducible urticaria over the first half of this year. And with Pelabresib, we now have a path forward for both the EU and the US. I'll go through that data and the path forward on a future slide.

    我們有一些重要的專案進度亮點,我們將在電話會議期間詳細介紹,但我想先重點介紹幾個方面。首先是瑞布替尼,我們基於積極的 3 期臨床試驗結果以及與 FDA 的互動,成功提交了針對最常見的 CIndU 類型的申請。今年上半年,我們將公佈其他兩種慢性誘發蕁麻疹亞型的剩餘數據。有了佩拉布雷西布,歐盟和美國現在都有了前進的方向。我將在下一張投影片中詳細介紹這些數據和後續步驟。

  • So overall, we met our upgraded full-year 2025 guidance. We expect to grow in 2026 through the largest patent expert in Novartis history, which I think demonstrates the strong performance we have on our key growth brands as well on our pipeline replacement power.

    總的來說,我們實現了上調後的 2025 年全年業績預期。我們預計在 2026 年透過諾華史上最大的專利專家實現成長,我認為這表明我們在關鍵成長品牌以及產品線更新方面都表現出色。

  • Then moving to slide 6. The growth drivers in the quarter continued their strong trajectory as well as on the full year. Here you see the full-year numbers. You can see KISQALI was up 57% on the full year. KESIMPTA was up 36%. SCEMBLIX up 85%. PLUVICTO on the PSMAfore launch having dynamic growth as well. We'll talk about each of these brands in turn. Overall, 35% growth in this portfolio, and this is the portfolio that will carry us through the end of the decade as well as with many of these brands taking us into the mid-2030s.

    然後切換到第6張投影片。本季成長動力延續了與全年一樣的強勁勢頭。這裡顯示的是全年數據。你可以看到 KISQALI 的股價較全年上漲了 57%。KESIMPTA 上漲了 36%。SCEMBLIX 上漲 85%。PLUVISTO 在 PSMAfore 的推出也實現了動態成長。我們將依序介紹這些品牌。總體而言,該投資組合成長了 35%,而該投資組合將帶領我們度過本十年末期,其中許多品牌也將帶領我們進入 2030 年代中期。

  • And moving to slide 7. On KISQALI, we grew 57% in the quarter to -- on the year to $4.8 billion, outpacing the market for CDK4/6. Now when you look at the chart on the on the lower left, our growth was 44% in Q4. When you remove the US RD adjustments, our global sales grew at 54% and our US sales growth was at 62%.

    接下來是第7張投影片。在 KISQALI 方面,我們本季成長了 57%,全年成長至 48 億美元,超過了 CDK4/6 市場。現在,當你查看左下角的圖表時,你會發現我們第四季的成長率為 44%。如果剔除美國研發調整,我們的全球銷售額成長了 54%,美國銷售額成長了 62%。

  • So in our view versus the consensus, the entire mess really came from these RD -- one-time RD adjustments. We remain fully confident on the $10 billion peak sales outlook for the brand. And what's underpinning that confidence is a very strong volume growth we're seeing across geographies.

    因此,我們認為(與普遍看法相反),整個混亂局面實際上源於這些 RD——一次性 RD 調整。我們對該品牌未來100億美元的銷售高峰前景仍充滿信心。支撐這種信心的,是我們看到各個地區銷售都實現了非常強勁的成長。

  • When you look at the middle panel, US eBC NBRx is now above 60% and holding steady. I think that really demonstrates the strong preference providers have for KISQALI, particularly in settings where we are uniquely positioned. And in Germany, we have over 80% NBRx share in the early breast cancer setting, which I think shows again this early strong performance for the launch in Germany, which we hope to carry over now to other ex US markets.

    從中間面板可以看出,美國 eBC NBRx 目前已超過 60%,並且保持穩定。我認為這充分體現了醫療服務提供者對 KISQALI 的強烈偏好,尤其是在我們具有獨特優勢的領域。在德國,NBRx 在早期乳癌領域擁有超過 80% 的市場份額,我認為這再次表明了該產品在德國上市初期的強勁表現,我們希望將這種表現延續到美國以外的其他市場。

  • So going to the last panel, yeah, I already went through many of the key elements, but I think I wanted to also note that eBC NBRx share is leading in both the overlapping and the exclusive population. Outside of the US, we have important launches in Italy and Spain coming up in 2026.

    所以,到了最後一個面板,是的,我已經講解了很多關鍵要素,但我想指出的是,eBC NBRx 的份額在重疊人群和專屬人群中都處於領先地位。除美國以外,我們計劃於 2026 年在義大利和西班牙推出重要產品。

  • And finally, we continue to bolster the data profile for KISQALI both with the data that we recently presented at San Antonio and ESMO. We'll continue to follow-up these patients over the long run and that should allow us to continue to have mature OS data over time, which we think will continue to bolster the portfolio. So very excited. KISQALI continues to be -- have the outlook to be the largest brand in Novartis's history.

    最後,我們持續加強 KISQALI 的數據概況,包括我們最近在聖安東尼奧和 ESMO 上展示的數據。我們將繼續對這些患者進行長期隨訪,這將使我們能夠隨著時間的推移繼續獲得成熟的 OS 數據,我們認為這將繼續加強產品組合。太激動了!KISQALI 繼續保持領先地位,並有望成為諾華歷史上最大的品牌。

  • Now moving to slide 8. KESIMPTA grew 36% to $4.4 billion on the year. You can see a continued steady performance of this brand driven by the continued expansion of the B-cell class within the MS. In the US, we had 27% growth in quarter four. Importantly, we see increasing adoption in naive patients, which are now 50% of our NBRxs now in first line.

    現在進入第8張投影片。KESIMPTA 的年營收成長了 36%,達到 44 億美元。可以看到,由於 MS 中 B 細胞類別的持續擴張,品牌的表現一直保持穩定。在美國,我們在第四季度實現了 27% 的成長。重要的是,我們看到初治患者的接受度不斷提高,目前初治患者占我們 NBRx 一線治療患者的 50%。

  • Outside of the US we're leading now with NBRx and 9 out of the 10 of the major markets that we track. And the core opportunity we see ex US going forward, is to continue to expand B-cell therapies in the 67% of patients who are not on B-cell therapies and receiving disease modifying therapies in MS.

    在美國以外,我們目前憑藉 NBRx 處於領先地位,在我們追蹤的 10 個主要市場中,有 9 個市場處於領先地位。我們看到,未來在美國以外地區的核心機會是繼續擴大 B 細胞療法在多發性硬化症患者中的應用,這些患者佔總患者人數的 67%,他們目前沒有接受 B 細胞療法,而是接受疾病修飾療法。

  • So we continue to generate additional value for KESIMPTA. We continue to progress also our every two-month formulation for KESIMPTA. So I think we're on a solid track with this brand to fully achieve our peak sales guidance of $6 billion-plus. Then moving to the next slide.

    因此,我們持續為 KESIMPTA 創造更多價值。我們每兩個月都會對 KESIMPTA 進行配方改進,而且這種改進還在繼續。所以我認為,我們這個品牌正朝著實現60億美元以上的銷售高峰目標穩步前進。然後進入下一張投影片。

  • PLUVICTO now really showing dynamic performance with the PSMAfore launch, 42% constant currency growth. We reached $2 billion in sales now overall globally. And that strong performance is driven primarily in the US where we continue to see strong uptake in the pre-taxing setting. Sales grew 75%. We saw a 4x increase in our PSMA share since approval, now reaching 16% in that setting.

    PLUVISTO 在 PSMAfore 推出後表現出了強勁的動態性能,以固定匯率計算增長了 42%。目前我們的全球銷售額已達20億美元。這一強勁表現主要得益於美國市場的強勁需求,我們在稅前市場持續看到強勁的市場接受度。銷售額成長了75%。自獲批以來,我們在 PSMA 市場的市佔率成長了 4 倍,目前已達到 16%。

  • We also see continued growth on across provider settings, including the highest growth in community where we now have over 790 treatment sites. Outside of the US, importantly, we've secured approvals in Japan and China, which also allowed us to continue to drive that ex US strong growth, and we expect that growth to accelerate now with the Japan and China launches upcoming.

    我們也看到各個服務提供機構持續成長,其中社區的成長最為顯著,目前我們已擁有超過 790 個治療點。在美國以外,更重要的是,我們已在日本和中國獲得批准,這也使我們能夠繼續推動美國以外的強勁成長,我們預計隨著日本和中國即將推出產品,這種成長將會加速。

  • Now, the next phase for PLUVICTO as we expect to get to the peak of the PSMAfore population over the course of this year will be the launch in the hormone sensitive setting, which adds about 75% additional patients to the patients we already have from the vision and PSMAfore population. That and sNDA has been submitted to the FDA as well as the NMPA in China and PMDA in Japan. We have the right foundation for that launch to be, we think, a rapid uptake with two-third of eligible hormone sensitive patients already with existing treaters or providers.

    現在,隨著我們預計今年PSMAfore人群達到峰值,PLUVICTO的下一個階段將是向激素敏感人群推出,這將使我們現有的視力障礙和PSMAfore人群患者數量增加約75%。此外,該補充新藥申請 (sNDA) 已提交給美國食品藥物管理局 (FDA)、中國國家藥品監督管理局 (NMPA) 和日本藥品和醫療器材管理局 (PMDA)。我們認為,我們已經為此次推廣奠定了良好的基礎,三分之二符合條件的荷爾蒙敏感患者已經找到了現有的治療者或醫療機構,因此該產品有望迅速普及。

  • So the capacity is well established. I did want to flag as well that we have new manufacturing sites that are coming online in California, in Florida, as well as in Japan, and China. We have over 440 treatment sites now outside of the US as well. So we've really taken this to scale, which positions us well for the PLUVICTO launches, ongoing LUTATHERA business, as well as our future RLT portfolio.

    因此,該能力已得到充分證實。我還想指出,我們在加州、佛羅裡達州、日本和中國都有新的生產基地即將上線。目前我們在美國以外也有超過440個治療中心。因此,我們已經真正將這項業務規模化,這使我們能夠更好地推進 PLUVICTO 的推出、持續的 LUTATHERA 業務以及我們未來的 RLT 產品組合。

  • Then moving to slide 10. LEQVIO reached blockbuster status in the quarter, an important milestone for this brand as we continue that steady trajectory that we often see for cardiovascular launches. 57% growth on the full year, 46% on the quarter. In the US, we continue to outpace the overall advanced lipid lowering market.

    然後切換到第 10 張投影片。LEQVIO在本季取得了重磅上市的成功,這對該品牌而言是一個重要的里程碑,也標誌著心血管藥物上市以來持續穩定成長的趨勢。全年成長57%,季增46%。在美國,我們持續領先整個先進降脂市場。

  • And our real focus is increasing depth in these health systems we prioritize where there's strong capabilities within the buy and build setting, strong interest in getting patients to goal, also focusing more on specialty areas that we've guided in the past. We saw 33% growth in the setting versus the prior year.

    我們真正的重點是深化我們優先考慮的這些醫療系統,這些系統在收購和建設方面擁有強大的能力,對幫助患者實現目標有著濃厚的興趣,同時我們也更加關注我們過去指導過的專業領域。與上一年相比,該領域的成長了 33%。

  • Now, key milestone for us outside of the US will be the NRDL listing which we achieved in China, and is now already now started in the first part of January. As you have heard in previous calls, we had very strong uptake in China in the private setting, and now with the NRLDL listing, the early signals are very strong for rapid uptake in the China market for LEQVIO.

    現在,對於我們在美國以外地區來說,一個重要的里程碑是獲得NRDL認證,我們在中國已經實現了這一目標,並且現在已經在1月上旬開始實施。正如您在之前的電話會議中聽到的那樣,我們在中國私人市場獲得了非常強勁的反響,現在隨著NRDLD上市,LEQVIO在中國市場迅速獲得認可的早期信號非常強烈。

  • So we're quite excited about that and it's a key focus area for us in 2026. We continue to build the evidence base for LEQVIO, important publications in various journals, mostly focused on adherence rates, as well as our ability to drive LDL-C down to goal regardless of which background therapy patients are on.

    所以我們對此感到非常興奮,這也是我們 2026 年的重點領域。我們繼續為 LEQVIO 建立證據基礎,在各種期刊上發表重要文章,主要關注依從率,以及無論患者接受何種背景治療,我們都能將 LDL-C 降至目標水平的能力。

  • Then moving to slide 11. SCEMBLIX had another strong quarter. We've reached again blockbuster status with this brand, and we have NBRx leadership in the US and Japan. 87% growth in Q4. Now if I could focus your attention on the middle panel in the US, we've reached 41% NBRx share now across all lines of therapy, and we plan to continue to grow that.

    然後轉到第 11 張投影片。SCEMBLIX 又迎來了一個強勁的季度。該品牌再次取得了巨大成功,我們在美國和日本的NBRx市場都佔據了領先地位。第四季成長了87%。現在,如果我想讓大家關註一下美國中間群體的情況,我們目前在所有治療領域中已達到 41% 的 NBRx 份額,我們計劃繼續擴大這一份額。

  • But the most important thing for us now is to drive the growth in the first line setting where we're trending ahead of our plan. We're already now in the mid-20% range in the front line setting. We want to drive that up and I think as we get -- as we've now secured broad access, we have the opportunity now to continue to make SCEMBLIX the medicine of choice on the front line for patients with CML.

    但對我們來說,現在最重要的是推動一線市場的成長,我們目前的成長動能已經超過了計畫。目前一線崗位的感染率已經達到 20% 左右。我們希望提高這個數字,而且我認為,隨著我們獲得廣泛應用,我們現在有機會繼續使 SCEMBLIX 成為 CML 患者一線治療的首選藥物。

  • And now outside of the US, we also continue to have our leadership in the third line setting with 72% share across the major markets that we track. The early line indication is now approved in 60 countries, and we've already just launched in Germany. We expect to get other EU markets online in the front line with launches expected in 2027.

    現在,在美國以外,我們在三線醫療領域也繼續保持領先地位,在我們追蹤的主要市場中佔有 72% 的市場份額。目前,該藥物的早期適應症已在 60 個國家獲得批准,並且我們已經在德國上市。我們預計其他歐盟市場將率先上線,預計 2027 年推出。

  • I think one ex US market to note, which I think shows the ability we have to drive assemble outside of the US is in Japan where we already have 45% frontline market share, NBRx share at 74%, second line NBRx share. So really strong outlook, confident in the $4 billion-plus outlook for this medicine.

    我認為值得一提的美國以外市場是日本,這反映了我們在美國以外地區推動組裝的能力。在日本,我們已經擁有 45% 的一線市場份額,NBRx 市佔率為 74%,二線 NBRx 市佔率也為 74%。所以前景非常樂觀,對這種藥物超過 40 億美元的銷售額充滿信心。

  • And moving to slide 12. COSENTYX grew 8% overall in the year getting to $6.7 billion on the steady march up to our $8 billion peak sales guidance. You can see the 11% growth on the quarter. In the US, we had 9% growth. That was driven by higher demand we saw both in hidradenitis and in IV.

    接下來是第12張投影片。COSENTYX 全年整體成長 8%,達到 67 億美元,並穩步邁向我們 80 億美元的銷售高峰預期。你可以看到本季成長了11%。在美國,我們的成長率為9%。這是由於我們在化膿性汗腺炎和靜脈注射方面都看到了更高的需求。

  • Right now, we're the number one prescribed aisle 17 across indications and that's really because of the strong access that we have, frontline access. In HS now we're the NBRx leader in naive patients with 51% share and 47% overall. And the naive market is 2.5 times the switch market. Certainly we've seen our competitor get traction in the switch market, but we're very much focused on that naive market where we have a really strong position.

    目前,我們在 17 號通道的處方量排名第一,涵蓋所有適應症,這完全是因為我們擁有強大的市場准入管道,一線市場准入管道。目前,我們在 HS 領域是 NBRx 的領導者,在初治患者中市佔率為 51%,整體市佔率為 47%。而普通市場的規模是交換器市場的 2.5 倍。當然,我們看到競爭對手在交換器市場取得了進展,但我們非常專注於我們擁有強大優勢的新興市場。

  • And the IV is also steadily advancing. 8% steady growth, 200 new accounts. We expect that to continue over the coming years. Outside of the US, no major changes, continued very strong growth, leading originator biologic in the EU and China. And overall, we would forecast COSENTYX to have, on average, mid-single-digit growth over the coming years as we get to that $8 billion peak sales potential.

    IV 指標也穩定成長,穩定成長 8%,新增 200 個帳戶。我們預計這種情況在未來幾年還會持續。除美國以外,沒有重大變化,繼續保持強勁成長,在歐盟和中國是領先的原廠生物製劑。總體而言,我們預測,隨著 COSENTYX 達到 80 億美元的銷售高峰潛力,未來幾年其平均成長率將達到中等個位數。

  • I did want to also flag that we have completed the submission with the US FDA for polymyalgia rheumatica, and so we're excited about that. That's an additional launch now for COSENTYX, and we've also -- are on track -- we're also on track to file in the EU and Japan in the first half.

    我還想指出,我們已經完成了向美國FDA提交的治療風濕性多肌痛的申請,對此我們感到非常興奮。這是 COSENTYX 的另一個產品發布,而且我們目前也正按計劃在上半年向歐盟和日本提交申請。

  • Then moving to slide 13. Our Renal portfolio has continued its rollout. I think it was steady progress and separate from that, we also have amended our zigakibart Phase 3 protocol, which I wanted to talk about in a bit more detail.

    然後轉到第 13 張投影片。我們的腎臟產品組合已持續推出。我認為這是一個穩定推進的過程,除此之外,我們也修改了 zigakibart 第三階段方案,我想更詳細地談談這個方案。

  • Starting with our Renal portfolio, our IgAN portfolio contributed 50% of the NBRx market growth versus prior year, driven equally by Vanrafia and Fabhalta. So I think we see steady uptake across these two brands. Also in C3G, Fabhalta continued steady adoption across the top accounts, and we hope to see that accelerate now over the course of 2026.

    從我們的腎臟產品組合來看,我們的 IgAN 產品組合貢獻了 NBRx 市場成長的 50%,與前一年相比,這主要得益於 Vanrafia 和 Fabhalta 的共同推動。所以我認為我們會看到這兩個品牌的銷售穩定成長。此外,在 C3G 領域,Fabhalta 在頂級客戶中繼續穩步普及,我們希望在 2026 年看到這一趨勢加速發展。

  • And outside of the US. Fabhalta is now approved in C3G in 45 countries. Vanrafia had its EU submission. So I think across these three brands, we have the opportunity to continue to build out a strong position. We do expect to be able to provide the full data set on the Fabhalta eGFR read out in IgAN soon and also move forward with the filing for a full approval in IgAN for Fabhalta. Now on ziga -- and we also expect, I should also note that Vanrafia full eGFR data set in the first half.

    以及美國以外的地區。Fabhalta 目前已在 45 個國家獲得 C3G 批准。Vanrafia已向歐盟提交了申請。所以我認為,憑藉這三個品牌,我們有機會繼續鞏固和發展強大的市場地位。我們預計很快就能提供 Fabhalta 在 IgAN 中的 eGFR 讀數的完整數據集,並推進 Fabhalta 在 IgAN 中的全面批准申請。現在關於ziga——我們還預計,我還應該指出,Vanrafia完整的eGFR數據集將在上半年發布。

  • On zigakibart, we have made the decision in order to optimize the overall label positioning and the competitive positioning to align our UPCR readout with the interim eGFR readout which we expect in the first half of 2027. And we expect that to support our BLA for a full approval.

    關於 zigakibart,我們決定優化整體標籤定位和競爭定位,使我們的 UPCR 讀數與我們預計在 2027 年上半年發布的 eGFR 中期讀數保持一致。我們預計這將有助於我們獲得生物製品許可申請的全面批准。

  • This was a decision based on an analysis of the Phase 1 and 2 data. We think we have the opportunity to be second to market with both proteinuria and the eGFR benefit. And so that, I think, is going to hopefully position us well to have a fourth Renal agent in our portfolio. We also have combination trials underway because we certainly see the opportunity in having a hemodynamic agent, having a Fabhalta, and having a zigakibart, the opportunity to use combinations to optimize care for these patients.

    這是根據第一階段和第二階段資料的分析所做的決定。我們認為我們有機會在蛋白尿和 eGFR 獲益方面都成為市場第二。因此,我認為這將使我們有希望在我們的產品組合中擁有第四種腎臟藥物。我們目前也在進行聯合試驗,因為我們看到了血液動力學藥物、Fabhalta 和 zigakibart 聯合用藥的機會,從而優化對這些患者的護理。

  • And moving to slide 14. Rhapsido is a US launch, which is obviously something we're very closely tracking, is delivering encouraging results. We are optimistic with already what we're seeing in the early days for this launch. We see strong demand with an encouraging mix of patients, both patients who are opposed to antihistamines, as well as post the biologic failure.

    接下來是第14張投影片。Rhapsido 是美國推出的產品,我們顯然非常密切地關注著它的發展,目前已取得了令人鼓舞的成果。我們對此次產品發布初期所取得的成果感到樂觀。我們看到強勁的需求,患者群體構成令人鼓舞,既包括反對使用抗組織胺的患者,也包括生物製劑治療失敗的患者。

  • We have a strong and positive response from allergists and dermatologists. The sampling and bridge program has over 2000 HCP starts, and I think that -- when we benchmark that versus other highly successful dermatology launches, it's right in line with some of the most successful dermatology launches.

    我們得到了過敏科醫生和皮膚科醫生的強烈積極回饋。樣品和橋樑計劃已啟動超過 2000 個 HCP,我認為——當我們將其與其他非常成功的皮膚科產品上市進行比較時,它與一些最成功的皮膚科產品上市完全一致。

  • We're also seeing early access wins. I think access will be now the gating factor. Every few months, we expect to bring on additional access on board that will allow a steady pickup in sales over the course of the year with more of a steady pickup in the second half of the year. I think really that second half I would encourage everyone to watch as we get that access together.

    我們也看到了早期進入帶來的成功。我認為准入將成為關鍵因素。我們預計每隔幾個月就會增加一些新的管道,這將使銷售額在一年中穩步成長,尤其是在下半年成長更為穩定。我覺得下半場真的值得大家一起觀看,因為我們會一起取得觀看權限。

  • And as a reminder, I think you all know well, clean safety, no box warnings, no contraindication, no required routine lab monitoring, no liver safety issues in the label. Fast relief across a broad population as fast as two weeks. Anecdotally, we hear reports as fast as a day or two days, patients are starting to see benefit. And it's the only oral therapy approved by FDA who remains symptomatic despite antihistamine therapy.

    再次提醒大家,我想大家都很清楚,產品安全可靠,沒有黑框警告,沒有禁忌症,無需常規實驗室監測,標籤上也沒有肝臟安全問題。最快兩週即可為廣大民眾提供快速緩解。據傳聞,最快一兩天內,患者就開始看到療效。而且,對於儘管接受抗組織胺治療但仍有症狀的患者,這是唯一獲得 FDA 批准的口服療法。

  • Now moving to slide 15. Now Rhapsido is one of these brands that we hope over time could become one of the largest brands in Novartis's history. This is an opportunity over multiple indications. I mentioned CSU launched, CIndU now positive data that we have in hand for one type, two more types coming. An HS readout in 2028.

    現在轉到第15張投影片。現在,我們希望Rhapsido能夠隨著時間的推移,成為諾華歷史上最大的品牌之一。這是一個涵蓋多個面向的機會。我提到 CSU 已經啟動,CIndU 現在我們已經掌握了一種類型的積極數據,還有兩種類型即將推出。2028 年 HS 讀數。

  • We have positive food allergy data which we'll be presenting in Q1 of this year, and that's leading us to now initiate a broad Phase 3 program in food allergy. We are on track for the RMS readouts second half of this year, but really mid of this year is the opportunity that we had to read out the two RMS studies, SPMS and myasthenia gravis ongoing. So when you take that together, you clearly have an opportunity with a medicine with a clean safety profile and strong efficacy with an oral -- as an oral option to have a significant long-term sales potential.

    我們獲得了積極的食物過敏數據,我們將在今年第一季公佈這些數據,這促使我們現在啟動一項廣泛的食物過敏第三期臨床試驗計畫。我們正按計畫在今年下半年公佈 RMS 研究結果,但實際上,今年年中是我們有機會公佈兩項 RMS 研究、SPMS 和重症肌無力研究結果的時候。因此,綜合考慮這些因素,很明顯,這種具有良好安全性和強效口服療效的藥物——作為一種口服選擇——具有巨大的長期銷售潛力。

  • Now moving to slide 16. Now Itvisma, which we haven't had as much attention, but it's something we continue to believe has a significant overall sales potential, total potential for this brand across the IV and IT of $3 billion-plus. This is a US approval that brings the one-time gene therapy to children two years and older.

    現在轉到第16張投影片。現在說說 Itvisma,雖然我們沒有給它太多關注,但我們仍然相信它具有巨大的整體銷售潛力,該品牌在 IV 和 IT 市場的總潛力超過 30 億美元。這是美國批准的一項措施,使得兩歲及以上的兒童可以接受一次性基因治療。

  • It's a broad label across patients who are non-sitters, sitters, and walkers. No AAV9 antibody titer limit for this treatment. There's a strong value proposition, single administration, durable efficacy, solid safety profile. So we see a multi-blockbuster opportunity for this brand. 7,500 children, teens, and adults have not been treated yet with Zolgensma IV. We also have an extensive experience in the US and ex US with this medicine.

    這是一個涵蓋範圍很廣的標籤,包括不能坐立的患者、能坐立的患者和能步行的患者。本療法對AAV9抗體滴度沒有限制。它具有強烈的價值主張,只需一次給藥,療效持久,安全性高。因此,我們認為該品牌擁有巨大的市場潛力。目前仍有7,500名兒童、青少年和成人尚未接受Zolgensma IV治療。我們在美國和美國以外地區也擁有豐富的此類藥物使用經驗。

  • Outside of the US, we've already been approved in the UAE one day after the FDA approval. And Europe and Japan submissions are completed. And as a reminder for Zolgensma, actually our sales are larger outside of the US than in the US, so there's certainly a significant opportunity ex US for Itvisma.

    在美國以外,我們在獲得 FDA 批准的第二天就在阿聯酋獲得了批准。歐洲和日本的申報工作已經完成。另外提醒 Zolgensma,實際上我們在美國以外的銷售額比在美國的銷售額更大,所以 Itvisma 在美國以外肯定有很大的機會。

  • And moving to slide 17. As I mentioned in the first slide, for collaborative, we read out in the quarter four the 96-week data from the Phase 3 MANIFEST program, which both on safety and efficacy, has now given us a path forward to, we believe, get this medicine registered, assuming a successful regulatory and clinical trial, Phase 3 trials.

    接下來是第17張投影片。正如我在第一張投影片中提到的,為了合作,我們在第四季度公佈了 MANIFEST 3 期計畫的 96 週數據,這些數據在安全性和有效性方面都為我們指明了前進的方向,我們相信,假設監管和臨床試驗(即 3 期試驗)取得成功,就能獲得該藥物的註冊。

  • In that study, we showed deep and durable responses and a comparable safety profile to ruxolitinib and myelofibrosis. You can see the data here on the left in terms of the spleen response. When you look at the data that we presented, we had a deep and durable spleen volume reduction. For the spleen volume, 35% reduction, landmark 91.5% versus 57.6%. We also saw sustained improvements in symptom scores and anemia.

    在該研究中,我們展示了深度和持久的療效,以及與魯索替尼治療骨髓纖維化相當的安全性。您可以在這裡左側看到脾臟反應方面的數據。從我們所展示的數據可以看出,脾臟體積得到了深度且持久的縮小。脾臟體積減少了 35%,標誌性變化為 91.5% 對 57.6%。我們也觀察到症狀評分和貧血狀況持續改善。

  • We had 2 times as many patients reaching goal with the spleen volume reduction and the TSS50. So we believe this medicine has disease modifying potential. We saw improvements in bone marrow pathology on the anemia. There is importantly now from a mortality standpoint, fewer deaths and progressions observed with pelabresib and ruxolitinib versus ruxolitinib alone. And the overall safety now is proven comparable with ruxolitinib, including comparable leukemic transformation rates, which was one of the topics that was holding this program back.

    透過脾臟體積縮小和 TSS50,達到目標的患者人數是原來的 2 倍。因此,我們認為這種藥物具有改善病情的潛力。我們發現貧血患者的骨髓病理有所改善。從死亡率的角度來看,現在與單獨使用魯索替尼相比,使用佩拉布雷西布和魯索替尼治療的死亡和疾病進展明顯減少。整體安全性現已證明與魯索替尼相當,包括白血病轉換率相當,而白血病轉換率正是阻礙此計畫進展的因素之一。

  • So with this data set, we have now an agreement with the EU to file in 2026 based on this data. And in the US, China, and Japan, we'll be starting a new Phase 3 study focused on patients who have high TSS50 at baseline where we believe we have the data set now to show we can achieve the regulatory milestone to ultimately get approval.

    因此,有了這套數據,我們現在與歐盟達成協議,將根據這些數據在 2026 年提交申報。在美國、中國和日本,我們將啟動一項新的 3 期研究,重點關注基線 TSS50 值較高的患者,我們相信我們現在擁有足夠的數據來證明我們可以達到監管里程碑,最終獲得批准。

  • Now moving to slide 18. I did want to also take a moment to mention our impact on global health. As I think many of you know, Novartis has been in global health for nearly 100 years, working on malaria and other neglected tropical diseases. With our Coartem medicine 25 years ago, we started a real sea change in the treatment of malaria, reaching now well over a billion patients with Coartem.

    現在轉到第18張投影片。我也想藉此機會談談我們對全球健康的影響。我想你們很多人都知道,諾華公司在全球健康領域已經耕耘了近100年,致力於瘧疾和其他被忽視的熱帶疾病的研究。25 年前,我們憑藉 Coartem 藥物,開啟了瘧疾治療領域的真正變革,如今 Coartem 已惠及超過 10 億名患者。

  • And now, with the recent data we presented in November, we have the opportunity to bring the first new malaria medicine, novel medicine such as Coartem in 25 years. This is KLU156 ganaplacide plus lumefantrine. It disrupts the parasite's internal protein system, very positive data here you see.

    現在,憑藉我們在 11 月公佈的最新數據,我們有機會在 25 年來首次推出新的瘧疾藥物,例如 Coartem 這種新型藥物。這是 KLU156 加那普拉西德加盧美芬汀。它破壞了寄生蟲的內部蛋白質系統,你看,這是非常正面的數據。

  • On the adjusted basis, 99.2% cure rate, versus 96.4% versus a five-day course, a three day course opportunity to block transmission. A very solid safety profile, so we're quite excited to bring this forward as part of our mission in global health.

    經過調整後,治癒率為 99.2%,而五天療程的治癒率為 96.4%,三天療程有機會阻止傳播。該產品具有非常可靠的安全性,因此我們非常高興能將其作為我們全球健康使命的一部分推出。

  • So moving to slide 19. Now, taken together, very good year for us from a pipeline standpoint in 2025. You can see we've met the vast majority of our milestones and trial starts. And I think that really shows the strong execution machinery we have now in R&D at the company. Very aligned across research and development and strong execution across our global development organization.

    接下來是第19張投影片。綜上所述,從管道建設的角度來看,2025 年對我們來說是非常好的一年。您可以看到,我們已經實現了絕大多數的里程碑目標和試驗啟動。我認為這充分展現了我們公司研發部​​門目前強大的執行能力。我們全球研發部門在研發方面高度協調一致,執行力強勁。

  • And turning to slide 20. For 2026, we're on track for seven pivotal readouts with the potential to strengthen the midterm outlook that we're guiding to, including the mid-single-digit sales growth we expect in the 2030s. A few particular readouts which I haven't mentioned, which I'll call out.

    翻到第20張投影片。2026 年,我們預計將獲得七項關鍵性數據,這些數據有望加強我們對中期前景的預期,包括我們預計在 2030 年代實現的中位數銷售成長。還有一些我沒有提到的特殊讀數,我在這裡特別指出。

  • On the left side, you can see Pelacarsen for CVRR. We do expect to readout middle of this year. It will be second half. It will be middle of this year, which, if positive, would allow us for a US submission this year. We also are on track for our submissions for Ianalumab in Sjogren's disease. And as well as the Del-zota DMD US submission, which assuming the closure of the Avidity deal will also happen in the first half of this year.

    左側可以看到 CVRR 的 Pelacarsen。我們預計今年年中公佈結果。這將是下半場。將會在今年年中,如果結果積極,我們將能夠在今年向美國提交申請。我們針對乾燥症的 Ianalumab 的申請也正在按計劃進行中。此外,Del-zota DMD 美國公司的申請,假設 Avidity 交易完成,也將在今年上半年進行。

  • Number of pivotal readouts, I mentioned Pelacarsen. There will be the Ianalumab readouts in hematology, which could have significant potential to drive that brand to very large long-term potential. Of course, Remibrutinib, as well as the Del-desiran DM1 Phase 3 readout, again, assuming the closure of the Avidity.

    關鍵讀數的數量,我提到了 Pelacarsen。血液學領域將會公佈 Ianalumab 的試驗結果,這可能極大地推動該品牌實現巨大的長期發展潛力。當然,Remibrutinib 以及 Del-desiran DM1 的 3 期結果,同樣假設 Avidity 的關閉。

  • We also have the additional readout of the [Dux4] interim data readout as well which could support accelerated launch and FSHD. However, that we would characterize as an upside case. And then a number of key study initiations you can see on the right-hand side of the chart. So another exciting pipeline year to continue to bolster our long-term growth profile.

    我們還有 [Dux4] 臨時資料讀取的附加讀取,這可能支援加速啟動和 FSHD。然而,我們會將其描述為一個利好案例。然後,您可以在圖表的右側看到一些關鍵的研究啟動。因此,又一個令人振奮的研發管線年,將繼續鞏固我們的長期成長前景。

  • And moving to slide 21, I will hand it over now to Harry.

    接下來請看第 21 張投影片,現在交給哈利。

  • Harry Kirsch - Chief Financial Officer, Member of the Executive Committee

    Harry Kirsch - Chief Financial Officer, Member of the Executive Committee

  • Yeah. Thank you, Vas. Good morning. Good afternoon, everybody. I now walk you through our financial results for the fourth quarter and the full year of 2025, which, as Vas mentioned, was very strong despite mid-year significant US gene entries. And as always, my comments refer to growth rates in constant currencies unless otherwise noted.

    是的。謝謝你,瓦斯。早安.大家下午好。現在我將帶您了解我們 2025 年第四季和全年的財務業績,正如 Vas 所提到的,儘管年中美國基因檢測數量顯著增加,但業績仍然非常強勁。像往常一樣,除非另有說明,我的評論均指以不變貨幣計價的增長率。

  • So in slide 22, 2025 marked another year of excellent execution. So over the last five years, as you can see here, we delivered an 8% sales average growth rate and a 15% core operating income average growth rate, driven by strong commercial execution, a great late-stage readout, and disciplined productivity programs.

    因此,在第 22 張投影片中,2025 年標誌著又一個執行力極佳的年份。因此,正如您在這裡看到的,在過去的五年裡,我們實現了 8% 的平均銷售成長率和 15% 的平均核心營業收入成長率,這得益於強大的商業執行力、良好的後期試驗結果和嚴格的生產力計劃。

  • This translated on the right side into more than 1,000 basis points of core margin expansion in constant currencies. And as you can see in reported currencies, it allowed us to reach our mid-term core margin target of 40% two years earlier than planned.

    換算過來,這相當於以固定匯率計算的核心利潤率提高了 1000 多個基點。正如您在報告貨幣中看到的那樣,這使我們能夠比計劃提前兩年實現 40% 的中期核心利潤率目標。

  • As you may recall, we initially planned for 2027. Now we have achieved it in 2025. With this result, I hope you agree, but I believe we have really elevated the company to a new level of sales performance, margin profile, and as I'll discuss later, free cash flow generation.

    您可能還記得,我們​​最初的計劃是 2027 年。現在我們已經在2025年實現了這個目標。我希望您能認同這一結果,但我相信我們已經真正將公司的銷售業績、利潤率以及(我稍後會討論的)自由現金流的產生提升到了一個新的水平。

  • On slide 23, just a quick summary, you see that we have delivered our full-year guidance in 2025 after upgrading twice throughout the year. And we guided to high single-digit sales growth and we delivered 8%. For cooperating income, we guided to low-teens and achieved 14%. And this is a strong result in the year, as I mentioned, the US generic entries for Entresto, Promacta, and Tasigna happened and it speaks really for the momentum of our priority brands as Vas already laid out, as well as disciplined cost management.

    在第 23 張投影片上,簡單總結一下,您可以看到,我們在 2025 年實現了全年業績指引,並在年內進行了兩次上調。我們引導實現了接近兩位數的銷售成長,最終達到了 8%。對於合作收入,我們引導至十幾個百分點,並實現了 14%。正如我之前提到的,這是今年取得的強勁成績,Entresto、Promacta 和 Tasigna 的美國仿製藥上市了,這充分體現了 Vas 已經闡述的我們重點品牌的強勁勢頭,以及嚴格的成本管理。

  • Turning to slide 24. So here are a few more details. For the full year, we delivered the described solid top and bottom line growth, record core margin, and record free cash flow, almost $18 billion. The core margin in the year improved by 210 basis points to 40.1%, and core EPS rose 17% to $8.98. Free cash flow grew 8% to $17.6 billion.

    翻到第24張投影片。以下是更多細節。全年來看,我們實現了預期的穩健營收和利潤成長、創紀錄的核心利潤率以及創紀錄的自由現金流,接近 180 億美元。本年度核心利潤率提升210個基點至40.1%,核心每股收益成長17%至8.98美元。自由現金流成長8%至176億美元。

  • Now, for the quarter on the right side here, now as expected, the US generics had an impact, which we see in quarter four and then Mukul will lay it out first half of second -- of next year of 2026. But then again, back to growth. Anyway, sales declined 1%, while it's cooperating income increased by 1%.

    現在,就右側的季度而言,正如預期的那樣,美國仿製藥產生了影響,我們在第四季度看到了這一點,然後 Mukul 將闡述 2026 年上半年的情況。但話說回來,一切又回到了成長上來。總之,銷售額下降了 1%,而其合作收入成長了 1%。

  • And the results were a little bit noisy due to some US RD adjustments, a positive impact in quarter four of 2024, so last year financially, and the negative impact this year in quarter four, 2025, mostly on generic brands. So excluding this adjustment, underlying quarter four sales growth would have been positive 3%. As said, the vast majority of the growth from net adjustments were Entresto and other generic brands like Promacta in the US. Core EPS in the quarter, $2.03 up 2%.

    由於美國研發部門的一些調整,結果有些波動,2024 年第四季(即去年)的財務狀況受到正面影響,而 2025 年第四季(即今年)的財務狀況受到負面影響,主要影響的是仿製藥品牌。因此,若不考慮此調整,第四季實際銷售成長率將為正3%。如前所述,淨調整帶來的成長絕大部分來自美國市場的 Entresto 和其他仿製藥品牌,如 Promacta。本季核心每股收益為 2.03 美元,成長 2%。

  • Now on slide 25, you can see our continued progress on free cash flow generation, which reached all $17.6 billion, all-time-high for the company in 2025. I think it shows you also beside the financial, the power of being a pure play pharma company. As you know, many years back, with even six businesses or even before the Alcon and Sandoz spin, these numbers were usually $10 billion to $12 billion range. And now, this is the earnings power of a focused and very successful pharma business.

    現在在第 25 張投影片中,您可以看到我們在自由現金流產生方面取得的持續進展,到 2025 年,自由現金流達到 176 億美元,創公司歷史新高。我認為這除了財務方面之外,也展現了純粹的製藥公司所擁有的力量。如你所知,多年前,即使只有六家公司,甚至在愛爾康和山德士分拆之前,這些數字通常都在 100 億至 120 億美元之間。這就是一家專注且非常成功的製藥公司如今所擁有的獲利能力。

  • We may, of course, focused on ensuring that the growth and cooperating income translates into high-quality earnings and strong cash flow generation. This robust cash flow allows us to reinvest in the business, pursue bolt-on acquisitions, and continue to return attractive capital to the shareholder through growing dividend and share buybacks.

    當然,我們也可以專注於確保成長和合作收入轉化為高品質的收益和強勁的現金流。強勁的現金流使我們能夠對業務進行再投資,進行補充收購,並透過不斷提高股息和股票回購,繼續為股東帶來可觀的回報。

  • On 2026, page 26, a quick reminder on our unchanged capital allocation strategy. And as you see, we continue to execute our balanced shareholder-friendly capital allocation in 2025. We invested more than $10 billion in R&D, an 8% increase versus per year, announced four acquisitions, 10 licensing deals, strengthening our key platforms, and pipeline across all of our four therapeutic areas.

    2026 年,第 26 頁,簡單提醒我們不變的資本配置策略。正如你所看到的,我們在 2025 年繼續執行平衡的、有利於股東的資本配置。我們在研發方面投入了超過 100 億美元,比每年增長 8%,宣布了四項收購、十項許可協議,加強了我們所有四個治療領域的關鍵平台和產品線。

  • On returning capital to our shareholders, we completed our $15 billion share buyback program in early July, and we launched a new up to $10 billion program, targeted to be completed by the end of 2027. Approximately $7.7 billion of that remains to be executed. In addition, we distributed $7.8 billion in dividends during the first half of 2025.

    在向股東返還資本方面,我們在 7 月初完成了 150 億美元的股票回購計劃,並啟動了一項新的高達 100 億美元的計劃,目標是在 2027 年底前完成。其中約有 77 億美元尚未執行。此外,我們在 2025 年上半年派發了 78 億美元的股利。

  • Now speaking of dividends, turning to slide 27, we are proposing a dividend of CHF3.70 per share, a 6% increase in Swiss francs, and even double-digits in dollars. And it's our 29th consecutive dividend increase in Swiss francs since company creation '96 and including years following the Sandoz and Alcon spins when we did not rebase the dividend at all. This reflects our long-term and long-standing commitment to a growing dividend in Swiss francs per share.

    現在談到股息,請看第 27 張幻燈片,我們建議每股派發 3.70 瑞士法郎的股息,相當於瑞士法郎的 6% 增長,美元甚至達到兩位數的增長。這是自 1996 年公司成立以來,我們連續第 29 年以瑞士法郎提高股息,其中包括 Sandoz 和 Alcon 分拆後的幾年,當時我們根本沒有調整股息基數。這體現了我們對每股瑞士法郎股息不斷增長的長期承諾。

  • That concludes my remarks. Before handing over, I'd like to briefly acknowledge that this will be my final earnings call as CFO of Novartis. It has been a privilege to serve in this role the last 13 years. And to work alongside Vas and so many other great colleagues to help guide the company through a period of significant transformation and performance improvement.

    我的發言到此結束。在交接之前,我想簡要說明一下,這將是我作為諾華財務長的最後一次財報電話會議。過去13年裡,能夠擔任這個職務是我的榮幸。能夠與 Vas 和許多其他優秀的同事一起工作,幫助公司度過一段重大轉型和業績提升的時期,我感到非常榮幸。

  • I'm very pleased to hand over to Mukul, a longtime colleague. In fact, we both started maybe at different stages of our career in 2003 at Novartis and very intensively worked together, especially the last 10 years. So with that, I turn over to Mukul to take you through 2026 guidance.

    我很高興能將工作交給我的老同事穆庫爾。事實上,我們倆可能在職業生涯的不同階段於 2003 年加入諾華公司,並且密切合作,尤其是在過去的 10 年裡。那麼,接下來就交給穆庫爾,讓他為大家帶來2026年的展望。

  • Mukul Mehta - Head of Business Planning and Analysis, Digital Finance and Tax

    Mukul Mehta - Head of Business Planning and Analysis, Digital Finance and Tax

  • A big thank you to you, Harry, for everything. It's been -- it is an honor to step into the role that you're leaving me with. And I look forward to getting to know everybody on the line in the months to come.

    哈里,非常感謝你所做的一切。能夠接替您留下的這個職位,我深感榮幸。我期待在接下來的幾個月裡認識線上的每位成員。

  • If you can go on slide number 29, please. For 2026, we expect sales to grow low single-digit and core operating income to decline low single-digits. And this reflects the 1% to 2% points of core margin dilution related to the Avidity deal that we had previously indicated. Importantly, in 2026, we will be growing top line through a period of highest Gx impact in our company's history.

    如果可以的話,請繼續到第29頁投影片。我們預期 2026 年銷售額將實現個位數低成長,核心營業收入將下降個位數低。這反映了我們之前指出的與 Avidity 交易相關的 1% 到 2% 的核心利潤率稀釋。重要的是,在 2026 年,我們將迎來公司歷史上 Gx 影響最大的時期,並實現營收成長。

  • At the same time, we will make sure that we continue to invest in R&D. We fund our launches appropriately while driving forward with the productivity improvement plans that the company has. As previously noted, we expect to close the Avidity deal in the first half of 2026.

    同時,我們將確保繼續加大對研發的投入。我們為產品發布提供充足的資金,同時推動公司既定的生產力提升計畫。如前所述,我們預計將在 2026 年上半年完成對 Avidity 的收購。

  • Looking ahead, we remain very confident in our 5% to 6% sales CAGR in the '25-'30 period, and we expect to return to 40%-plus core margin in 2029 as laid out in our Capital Markets Day. For 2026, we expect core net financial income expenses to be around $1.7 billion. This is higher than the '25 levels, and this is largely due to the anticipated funding costs related to the Avidity deal, which we have previously indicated is primarily going to be debt funded. We also expect the core tax rate to remain around 16.5%.

    展望未來,我們對 2025-2030 年期間 5% 至 6% 的銷售複合年增長率仍然非常有信心,並且正如我們在資本市場日上所闡述的那樣,我們預計到 2029 年核心利潤率將恢復到 40% 以上。我們預計 2026 年核心淨財務收入支出約為 17 億美元。這高於 2025 年的水平,這主要是由於與 Avidity 交易相關的預期融資成本,我們之前已經指出,這筆交易主要將透過債務融資。我們也預計核心稅率將維持在 16.5% 左右。

  • Moving to slide 30, please. As we have previously indicated as well, 2026 is going to be a year of two halves. We expect -- we continue to expect strong volume growth from our priority brands throughout 2026. But we have to understand that for the first half of the year, we will have a tough prior year base with Entresto, Promacta, and Tasigna generics having entered the US market mid-2025.

    請翻到第30張投影片。正如我們之前所指出的,2026年將是分成兩個階段的一年。我們預計—我們預計到 2026 年,我們的重點品牌將繼續保持強勁的銷售成長。但我們必須明白,今年上半年我們將面臨一個艱難的上一年基數,因為 Entresto、Promacta 和 Tasigna 的仿製藥在 2025 年年中才進入美國市場。

  • With that, we expect the first half of the year sales to decline low single-digit and core operating income to decline low double-digit. Additionally, Q1 will be impacted by the 2% positive gross net impact that we had in the base Q125, which will weigh on the quarter-on-quarter growth rate in Q1.

    因此,我們預期上半年銷售額將出現個位數低幅下降,核心營業收入將出現兩位數低點下降。此外,由於第一季(Q125)基準期內毛淨成長 2%,第一季業績也將受到影響,這將對第一季環比成長率造成壓力。

  • That said, in the second half of the year, we expect a clear improvement with sales growing mid-single-digit and core operating income growing mid- to high-single-digit. This takes us to our full-year guidance of low single-digit on top-line.

    也就是說,我們預計下半年情況將明顯好轉,銷售額將達到中等個位數成長,核心營業收入將達到中等至高個位數成長。這使我們對全年營收成長的預期降至個位數低點。

  • So moving to slide 31, please. If exchange rates remain at their late January levels, we expect a positive 2 to 3 percentage point impact on our full-year sales and a positive 1% point impact on core operating income. And as a reminder, which Harry has conveyed previously, we published updated FX estimates monthly on our website.

    請翻到第31張投影片。如果匯率維持在 1 月下旬的水平,我們預計全年銷售額將受到 2 至 3 個百分點的正面影響,核心營業收入將受到 1 個百分點的正面影響。再次提醒大家(哈利之前也提到過),我們每個月都會在網站上發布更新後的外匯預測。

  • So that concludes my remarks, and I hand it over back to Vas.

    我的發言到此結束,現在把發言權交還給瓦斯。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thank you, Mukul. I want to take a moment as well to acknowledge Harry Kirsch's incredible contributions to Novartis over 23 years. Over my tenure as CEO now, entering my ninth year, Harry's been by my side as we've transformed the company into a pure play, and I think unlocked really outstanding shareholder returns, outstanding financial performance.

    是的。謝謝你,穆庫爾。我還要藉此機會感謝哈里·基爾希在過去 23 年裡為諾華公司做出的卓越貢獻。在我擔任執行長的第九個年頭裡,哈利一直陪伴在我身邊,我們一起將公司轉型為一家純粹的金融公司,我認為這實現了真正傑出的股東回報和傑出的財務表現。

  • But probably less visible is the strength of the finance organization Harry's built, as well as the culture he's created in the company around productivity, financial discipline, and operational excellence. He'll surely be missed, but will continue his legacy in the years to come. And a big welcome to Mukul who I've known for many years. He'll be a great addition to the team, and we'll continue the strong track record of Novartis's finance and delivering strong operational execution.

    但哈里建立的財務組織的實力,以及他在公司中圍繞生產力、財務紀律和卓越運營所創造的文化,可能不太被關注。人們一定會懷念他,但他的精神遺產將在未來的歲月裡繼續傳承下去。熱烈歡迎穆庫爾,我認識他很多年了。他的加入將大大增強團隊實力,我們將繼續保持諾華在財務和營運執行方面的良好記錄。

  • Now moving to the next slide. I do want to take a moment to build on Mukul's comments on our confidence in the guide on our 5% to 6% sales CAGR to 25% to 30%. That includes the impact of Entresto in 2026 as well as the US MFN agreements impact.

    現在進入下一張投影片。我想藉此機會補充 Mukul 對我們 5% 至 6% 的銷售複合年增長率預期達到 25% 至 30% 的信心的評論。這包括 2026 年 Entresto 的影響以及美國最惠國待遇協議的影響。

  • You can see in the chart, we do expect that some generic impact. So a lot of that is front loaded in the early part of the five-year trajectory here, a number of brands where we believe we can drive dynamic growth and in the middle column. And then lastly, a strong set of assets that we parabolized in our pipeline, but this ranges from Ianalumab, our various PLUVICTO and Actinium PSMA, Pelacarsen, as well as the Avidity assets, amongst others that give us the opportunity to not only hopefully deliver the 5% to 6%, but if we're successful on those pipeline assets, we could even drive higher growth in the period.

    從圖表中可以看出,我們預期會有一些普遍性的影響。因此,許多工作都集中在五年發展軌跡的早期階段,我們認為可以推動多個品牌實現動態成長,而這些品牌則位於中間階段。最後,我們還有一系列強大的資產,這些資產在我們的研發管線中得到了充分的利用,其中包括 Ianalumab、我們的各種 PLUVICTO 和 Actinium PSMA、Pelacarsen 以及 Avidity 的資產等等,這些資產不僅讓我們有機會實現 5% 到 6% 的增長目標,而且如果我們在這些研發期間取得更高資產的成長。

  • So moving to slide 34, and in closing, strong performance in 2025. We delivered the guidance that we outlooked and got to our 40% core margin early. Our priority brands continue to outperform, and that's what's going to drive our growth through the second half of '26 and then through the five years to come.

    接下來是第 34 張投影片,最後,我們預測 2025 年將取得強勁的業績。我們實現了預期目標,並提前達到了 40% 的核心利潤率。我們的重點品牌持續表現出色,這將推動我們在 2026 年下半年以及未來五年內成長。

  • We're advancing the pipeline meaningfully in 2026. We advanced it meaningfully in 2025 with seven pivotal readouts this year. And we're confident in that mid- to long-term growth guidance. So with that, we can close this section and move to questions. So operator, we can open the line. Thank you.

    我們將在 2026 年顯著推進該專案。我們透過今年的七項關鍵性數據,在 2025 年取得了實質進展。我們對中長期成長預期充滿信心。那麼,本節就到此結束,接下來進入問答環節。操作員,我們可以開通線路了。謝謝。

  • Operator

    Operator

  • (Operator Instructions) Sachin Jain, Bank of America.

    (操作員指示)Sachin Jain,美國銀行。

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Perhaps I'll just kick off with thanking Harry for his support and insight over the years.

    或許我應該先感謝哈利多年來的支持和真知灼見。

  • The questions, I guess, with Vas on remi. You've talked about avoiding liver monitoring in MS given their Hy's law. And competition recently has been vocal, avoiding monitoring in the label when monitoring's been involved in the studies could be difficult. So why don't you just give us any color on FDA conversations around this topic and where the monitoring in the studies picked up events that required dose changes?

    我想,這些問題是關於Vas服用remi的。您曾談到,鑑於多發性硬化症患者的Hy's定律,應避免對其進行肝臟監測。最近競爭激烈,如果研究中涉及監測,那麼在標籤中避免監測可能會很困難。那麼,您能否透露FDA就此主題進行的討論細節,以及研究中的監測發現了哪些需要調整劑量的事件?

  • And then a quick follow on efficacy. Any color on what you're targeting on relapse rate of progression, given we have no Phase 2 to go off here? Thank you.

    然後快速跟進一下療效。鑑於目前還沒有二期臨床試驗數據可供參考,您能否就復發率和疾病進展率的目標設定一些具體資訊?謝謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, Sachin. So I think first on liver, I think we should first take a step back and note that we already have an approval, an approved label without any liver safety discussion in the label, which it just points to the fact that remibrutinib structurally does not have the off-target toxicity as we believe that the structures of some of the other molecules do. And so that we didn't have any of that in the existing CSU label.

    是的。謝謝你,薩欽。所以,首先關於肝臟方面,我認為我們應該先退一步,注意到我們已經獲得了批准,批准的標籤中沒有任何關於肝臟安全性的討論,這恰恰表明,瑞布替尼的結構上沒有我們認為其他一些分子結構所具有的脫靶毒性。因此,現有的 CSU 標籤中沒有任何此類內容。

  • I think I have an abundance of caution given the findings of the other competitors. FDA asked us for a limited liver monitoring, to our understanding, that's more limited than the liver monitoring than our competitors have had to add to their programs. And our full plan is assuming that we -- and as we've seen today, no liver signals in our study, we fully plan to advocate the FDA that we should stick to the current label and in the absence of any information to really -- any data to really change the current label with respect to that.

    鑑於其他競爭對手的調查結果,我認為我的謹慎態度是多餘的。據我們了解,FDA 要求我們進行有限的肝臟監測,這比我們的競爭對手必須在其專案中增加的肝臟監測範圍要小。我們的整個計劃是假設——正如我們今天所看到的,我們的研究中沒有肝臟信號——我們完全計劃向 F​​DA 遊說,我們應該堅持目前的標籤,並且在沒有任何信息——沒有任何數據可以真正改變目前的標籤的情況下。

  • I'd also note that for, in general, for competitors, when there is a Hy's law case, at least to our understanding, whether it's one, two, three cases that generally leads to REMs programs, leads to monitoring, does lead to warnings and precautions, just given the safety risk that these -- that that creates for patients who have alternative therapies. And in RRMS, there's numerous alternative therapies, so safety is absolutely, absolutely paramount.

    我還想指出,一般來說,對於競爭對手而言,當出現 Hy 定律案例時,至少據我們了解,無論是一個、兩個還是三個案例,通常都會導致 REMs 項目、監測、警告和預防措施,因為這些案例會給接受替代療法的患者帶來安全風險。對於復發緩解型多發性硬化症 (RRMS) 來說,有許多替代療法,因此安全性絕對是最重要的。

  • So I think that's our overall perspective on the safety. We're very confident in overall remi safety, and assuming two positive Phase 3 trials this summer, the potential for this to be a very significant medicine.

    所以我認為這就是我們對安全性的整體看法。我們對雷米的整體安全性非常有信心,假設今年夏天兩項 3 期試驗結果為陽性,那麼它有可能成為一種非常重要的藥物。

  • Now with respect to efficacy, I think it's very fair to point out we don't have Phase 2 data. We went to Phase 3 based on the findings that we saw from competitors. So -- but I think given that we know that we hit the target very well at 25 mg BID and we move up to 100 mg BID in the study, we think we'll definitely have strong target saturation.

    至於療效方面,我認為必須指出,我們還沒有二期臨床試驗數據。我們根據從競爭對手那裡獲得的經驗,進入了第三階段。所以——但我認為,鑑於我們知道 25 毫克 BID 的劑量已經很好地達到了目標,並且我們在研究中將劑量提高到 100 毫克 BID,我們認為肯定會達到很高的目標飽和度。

  • We think the molecule is very well designed. We look at the PK, the PD of the molecule. So that gives us confidence that assuming the class is effective against RMS, we will have a compelling profile from an efficacy standpoint and with the safety profile and with the fact that we're established now in the market having already launched should give us a strong value proposition.

    我們認為該分子設計得非常好。我們研究分子的藥物動力學和藥效學。因此,我們有信心,假設該類藥物對 RMS 有效,那麼從療效角度來看,我們將具有令人信服的療效,而且安全性也很好。此外,我們已經在市場上站穩腳跟,產品已經上市,這將為我們帶來強大的價值主張。

  • Operator

    Operator

  • Simon Baker, Rothschild & Co Redburn.

    西蒙貝克,羅斯柴爾德公司雷德伯恩分公司。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Two, if I may, please. Firstly on -- just continuing on remibrutinib. Going off from Sachin's question, I just wonder if you could give us your updated thoughts on the commercial opportunities here in MS because it feels like that your enthusiasm for remi and MS has increased over time, that a couple of years ago there was talk of almost MS being playing second fiddle to CSU. So just updated perspectives on your thoughts on the commercial opportunity.

    如果可以的話,請給我兩個。首先,繼續服用瑞布替尼。承接 Sachin 的問題,我想請您談談您對 MS 商業機會的最新看法,因為感覺您對 remi 和 MS 的熱情隨著時間的推移而增加,而幾年前還有人說 MS 幾乎要屈居 CSU 之下。所以,我只是想更新您對這個商業機會的看法。

  • And then moving on to Pelacarsen. You've now guided to a 2H '26 readout. Given this is an event-based study, could you just give us any thoughts on potential risks and risk mitigation for this, what appears to be significantly lower event rate? Does this run the risk of creating additional noise in the study? Or is that more than offset by the powering assumptions and the design that you've built in there? Any thoughts on that would be very helpful. Thanks so much.

    然後是佩拉卡森。您現在已引導至 2026 年 2 月的讀數。鑑於這是一項基於事件的研究,您能否就此潛在的風險和風險緩解措施提出一些想法,因為事件發生率似乎明顯較低?這樣做是否會為研究帶來額外的干擾?或者說,這完全可以被你在其中建造的動力假設和設計所抵消?任何想法都將非常有幫助。非常感謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, Simon. So first on the commercial opportunity, I think it's really going to be data-driven. I think our base case assumption is that an oral drug will struggle to have the same level of efficacy as monoclonal antibodies, but in hitting the B-cell pathways in MS. And because of that, that's still B-cell monoclonal antibodies will be the dominant class, but there will be a number -- a large number of patients that would want an oral option who don't want to go through injectable therapy.

    是的。謝謝你,西蒙。首先,就商業機會而言,我認為它將真正以數據為驅動。我認為我們的基本假設是,口服藥物很難達到與單株抗體相同的療效水平,但在多發性硬化症中,口服藥物可以作用於 B 細胞路徑。正因如此,B 細胞單株抗體仍將是主要類別,但會有許多患者希望獲得口服治療,而不想接受注射治療。

  • I mean, as I noted in my slide, still 25% of patients in the US and 65% outside of the US are on DMTs that are not and are not on B-cell -- injectable B-cell therapy. So there's a large market there on its own. And then I think it will depend if the if the efficacy and safety profile, particularly the efficacy profile in the case of remi in our hands, is compelling enough to have a broader market. So I think we'll certainly see based on the data.

    我的意思是,正如我在幻燈片中提到的,美國仍有 25% 的患者,美國以外仍有 65% 的患者正在接受非 B 細胞療法的 DMT,並且沒有接受注射型 B 細胞療法。所以那裡本身就有一個巨大的市場。然後我認為這將取決於療效和安全性,特別是就我們掌握的雷米而言,其療效是否足夠令人信服,從而擁有更廣泛的市場。所以我覺得我們一定會根據數據來判斷。

  • But even if we take it as a given that there is a large B-cell monoclonal class out there, there is a large market opportunity beyond that which we think is important. And that's, of course, the question is, with the brain penetrant properties of our molecule, does that lead to other opportunities either in SPMS or in the control of RMS to provide another dimension? And that will all be data driven as well.

    但即使我們認定目前存在大量的 B 細胞單株抗體,除了我們認為重要的部分之外,還有很大的市場機會。當然,問題在於,我們這種分子具有穿透大腦的特性,這是否會為繼發性進展型多發性硬化症 (SPMS) 或復發緩解型多發性硬化症 (RMS) 的控制帶來其他機會,從而提供新的維度?這一切都將以數據為驅動。

  • So in this case, I'll exceptionally take the second question, but if everyone could limit themselves to one question. Pelacarsen, so we expect a mid-year readout. The study is going to completion in terms of the number of events that we had originally outlined. We had powered up the study, you'll recall, during the process of the Phase 3.

    所以,在這種情況下,我將破例回答第二個問題,但希望大家能只提一個問題。佩拉卡森,因此我們預計年中將公佈相關數據。就我們最初設想的事件數量而言,這項研究即將完成。您可能還記得,我們​​在第三階段過程中啟動了這項研究。

  • So we feel like we're adequately powered to demonstrate both at the 70 milligram per DL cutoff and the 90 milligram per DL cutoff, the CVRR that that we're targeting. And so I don't think there's necessarily any risk associated with going in full. I think what it does indicate is that the event rates are lower than what we had modeled from the published literature, and I think that's just something that is just the reality now that we found.

    因此,我們感覺我們有足夠的能力證明,在每 DL 70 毫克和每 DL 90 毫克的閾值下,我們能夠達到我們所期望的 CVRR。所以我認為全面投入不一定有任何風險。我認為這表明事件發生率低於我們根據已發表的文獻建立的模型,我認為這就是我們現在發現的現實。

  • We suspect it has to do with the fact that we've really optimally managed these patients for all other risk factors, particularly LDL lowering. And I think that, of course, has an impact on event rates as well. So we'll see and look excited to see this data and hopefully creating an entire new class of medicines that can help a whole group of patients that have no other option. And so I think with a positive study, we have the opportunity to give these patients a hopeful solution against sudden cardiac death and some of the other things that can happen for patients with elevated LPLA.

    我們懷疑這與我們對這些患者所有其他風險因素(特別是降低低密度脂蛋白膽固醇)進行了非常有效的管理有關。我認為這當然也會對事件發生率產生影響。所以我們將拭目以待,並對這些數據感到興奮,希望能夠創造出一整類全新的藥物,幫助那些別無選擇的患者群體。因此,我認為,如果研究結果積極,我們就有機會為這些患者提供一個有希望的解決方案,以預防猝死以及LPLA升高患者可能發生的其他一些情況。

  • Operator

    Operator

  • Matthew Weston, UBS.

    瑞銀集團的馬修‧韋斯頓。

  • Matthew Weston - Analyst

    Matthew Weston - Analyst

  • Thank you very much. Can I also add my thanks to Harry for all his support and best of luck for the future, Harry.

    非常感謝。我還要感謝哈利一直以來的支持,並祝福哈利未來一切順利。

  • Vas, KISQALI is building into a fantastic and highly profitable medicine for Novartis. And I guess the only challenge is it has an LOE just after your 2030 time window. What are the options in-house to extend the franchise further in breast cancer? And given the third data that we've seen from a competitor, what other options are there from BD that could potentially -- or is oncology, I should say, a category where BD looks like somewhere you should supplement the Novartis pipeline?

    Vas,KISQALI 正成為諾華公司一款非常棒且利潤豐厚的藥物。我猜唯一的挑戰是它的 LOE 正好在你 2030 年的時間窗口之後。公司內部有哪些方案可以進一步拓展在乳癌領域的業務?鑑於我們從競爭對手那裡看到的第三份數據,BD 還有哪些其他選擇可以潛在地——或者我應該說,腫瘤學是否是 BD 應該補充諾華產品線的一個領域?

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. So I think there's actually two questions in there, but I'll also take both of these, Matthew, because it's you, Matthew. With respect to KISQALI, I think right now, we got to a mid-2031 with the pediatric exclusivity that we would expect for this brand in the US. I think it's longer outside of the US, depending on the market.

    是的。所以我覺得這裡面其實有兩個問題,不過馬修,這兩個問題我都會回答,因為是你,馬修。關於 KISQALI,我認為目前我們已經達到了該品牌在美國的兒科獨家銷售期限,預計到 2031 年中期。我認為在美國以外,時間會更長,具體取決於市場情況。

  • Our core goal at the moment is our CDK2, CDK24, and CDK4 programs, all of which now are in the clinic, and we're advancing as fast as we can to see which of these medicines can provide either additional benefit in the post-KISQALI setting or either in combination and we'll see what we ultimately learn.

    我們目前的核心目標是 CDK2、CDK24 和 CDK4 項目,所有這些項目現在都已進入臨床階段,我們正在盡最大努力推進,看看這些藥物中哪些可以在 KISQALI 試驗後提供額外的益處,或者聯合用藥,我們將看看最終能學到什麼。

  • Of course, we also are advancing our radioligand therapy portfolio. We have two HER2 RLTs now in the clinic. Those will be important to watch, as well as the [neobamicin] RLT as well in breast cancer. So number of shots on goal, and I think those will all be very important for us to continue the life cycle manage KISQALI, as you rightfully point out beyond the mid-2030s. I always think about it as a full-year 2032 effect for this brand.

    當然,我們也在推動放射性配體療法產品組合的開發。我們診所目前有兩例 HER2 RLT 病例。這些都值得關注,還有[新黴素]RLT在乳癌中的應用。所以射門次數,我認為這些對於我們繼續管理 KISQALI 的生命週期非常重要,正如您所正確指出的那樣,直到 2030 年代中期以後。我一直認為這對該品牌來說是2032年全年都會產生的影響。

  • Now, I think on -- with respect to BD and M&A, I think absolutely. I mean, we see amongst our therapeutic areas that, clearly, oncology is one we'll have to focus on, so we'll continue to focus there as we have. I would say we've had just more opportunities and traction in the last years in cardiovascular immunology and neuroscience. You've seen us do a large number of deals in those spaces.

    現在,就業務拓展和併購而言,我認為絕對是這樣。我的意思是,在我們所有的治療領域中,很明顯,腫瘤學是我們必須重點關注的領域,所以我們將繼續像以往一樣專注於此。我認為,近年來我們在心血管免疫學和神經科學領域獲得了更多的機會和進展。您已經看到我們在這些領域達成了大量交易。

  • But we'll continue to see, and of course it's a high priority to continue to build oncology now that we have the scale we're building from SCEMBLIX, PLUVICTO, KISQALI. And so if we find good opportunities, good assets, we'll certainly go after them.

    但我們會繼續觀察,當然,現在我們已經從 SCEMBLIX、PLUVICTO 和 KISQALI 等公司獲得了規模優勢,繼續發展腫瘤業務是我們的首要任務。因此,如果我們發現好的機會、好的資產,我們一定會抓住它們。

  • Operator

    Operator

  • Peter Verdult, BNP Paribas.

    Peter Verdult,法國巴黎銀行。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Yes. Thanks. Peter Verdult, BNP Paribas. Vaz, just on Rhapsido and Ianalumab, given we're now in an MFN world, how should we be thinking about ex US launch plans for what are clearly commercially significant assets? I'm basically just pushing my luck to see how specific you're comfortable being about changing in rest of the world launch strategies for important assets like Rhapsido and Ianalumab. Thank you.

    是的。謝謝。Peter Verdult,法國巴黎銀行。Vaz,就 Rhapsido 和 Ianalumab 而言,鑑於我們現在處於最惠國待遇的世界,我們應該如何考慮這些顯然具有重要商業價值的資產在美國以外的上市計劃?我基本上就是想看看,對於 Rhapsido 和 Ianalumab 等重要資產在世界其他地區的上市策略的改變,你們能接受的具體程度是多少。謝謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yes. So I think this is high in our minds. We're working through our strategies here on Rhapsido. Given that it's already launched, of course, we would be exposed on the first pillar of the MFN approach, which is on the Medicaid rebate. It's more limited, and I think there we can manage. We think we have good options to manage the ability to launch Rhapsido globally. Of course we'll have tighter pricing corridors, but that's something we think we can manage.

    是的。所以我覺得這件事在我們心中佔有很高的位置。我們正在 Rhapsido 上製定策略。鑑於它已經啟動,我們當然會在最惠國待遇方法的第一支柱——醫療補助回扣方面面臨風險。雖然範圍較窄,但我認為我們可以應付。我們認為我們有很好的方案來管理 Rhapsido 在全球範圍內的推廣能力。當然,我們的定價區間會更窄,但我們認為這是我們可以控制的。

  • Ianalumab is more complex. As we get to launches in 2027 in the G7-plus countries, there, of course, it's on the entire market of US net price, not just Medicaid. And so we're working through strategies. Absolutely it's our aspiration to get these medicines launched in all of these markets, given the patients that need them, but we certainly can't adversely affect the US market.

    Ianalumab 則更為複雜。到 2027 年,G7 及其他國家將開始推出該產品,當然,屆時它將面向整個美國淨價市場,而不僅僅是醫療補助計劃。所以我們正在製定策略。當然,考慮到患者的需求,我們非常希望這些藥物能在所有這些市場上市,但我們絕對不能對美國市場造成不利影響。

  • And so we're just going to have to be thoughtful about looking at where are there opportunities to price with appropriately for the value that Ianalumab brings, given the PPP adjustments and some of the other elements of how pricing is looked at, other things we can do to manage this. It's all in the works. I think we'll have a better sense over the course of this year on Ianalumab. But on Rhapsido, we feel confident we have a way forward to get a global launch moving ahead.

    因此,我們必須認真考慮如何根據 PPP 調整和其他一些定價因素,以及我們可以採取的其他措施來管理 Ianalumab 的價值,找到合適的定價機會。一切都在籌備中。我認為今年一段時間後,我們會對 Ianalumab 有更清晰的了解。但對於 Rhapsido,我們有信心找到前進的方向,推動其在全球範圍內的發布。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Well, thank you so much. On Pelacarsen, Novartis has said previously that a delay in the HORIZON trial readout would stem either from overestimating the baseline risk or underestimating the treatment effect. Do you have a sense of what is at work here?

    非常感謝。關於 Pelacarsen,諾華公司先前曾表示,HORIZON 試驗結果的延遲公佈要么是由於高估了基線風險,要么是由於低估了治療效果。你是否意識到這裡面究竟是什麼原因造成的?

  • I would think the baseline risk, if it were overestimated, would question the value of interact or lowering LPA in the first place. And I would think that Novartis should have a better handle on treatment effect based on early studies. So any color of Novartis's view at this point would be helpful. Thank you.

    我認為,如果基線風險被高估,那麼首先就應該質疑交互作用或降低 LPA 的價值。我認為,根據早期研究,諾華應該對治療效果有更清楚的了解。因此,了解諾華公司目前的觀點將很有幫助。謝謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • I wish we knew Steve, Honestly, I can only give you an opinion. I can't actually give you a fact because we're completely blinded and we have no database insight. We believe that we have appropriately estimated the baseline risk. And that's after many rounds of looking at it.

    我希望我們能認識史蒂夫。說實話,我只能給你一些意見。我無法提供確切的事實,因為我們完全被蒙在鼓裡,沒有任何資料庫資訊。我們認為我們已經適當地估計了基線風險。而且這還是在反覆查看之後才做出的決定。

  • So it might be that that baseline risk is more prominent at a higher LPA threshold. I think in my mind, it really comes down to what LPA threshold are we appropriately thinking about the baseline risk and how, and this is, again, I think not in our -- no way to know if this is correct, but my assumption is that at lower LPLA levels there could be more interactions with LDL and other risk factors, and the LPA becomes more dominant as you get to higher LPLA levels. And because the risk goes up almost linearly at a higher LPA, that becomes the dominant risk factor.

    因此,在較高的 LPA 閾值下,這種基線風險可能更為突出。我認為,歸根結底,我們應該如何適當地考慮 LPA 閾值來判斷基準風險,以及如何判斷。再次強調,我認為我們無法確定這是否正確,但我的假設是,在較低的 LPA 水平下,LPA 可能與 LDL 和其他風險因素發生更多相互作用,而隨著 LPA 水平的升高,LPA 的作用會變得更加顯著。由於 LPA 越高,風險幾乎呈線性增長,因此 LPA 成為主要風險因素。

  • And so the studies obviously have some portion of patients at the 70 to 90 to 70 to 100. We've, I think, announced in our papers that, overall, our median is 108. So, that's the kind of our best guess in terms of the risk profile and how we've estimated. Obviously, we would love for this to be that our treatment effect is larger than we expect, and that would be the reason for this, but there's just no way to know that at this time.

    因此,這些研究中顯然有一部分患者的年齡在 70 到 90 歲之間,或 70 到 100 歲之間。我認為,我們在文件中已經宣布,總體而言,我們的中位數是 108。所以,這就是我們對風險狀況的最佳猜測和估計。顯然,我們希望治療效果比預期的要好,而這正是造成這種情況的原因,但目前我們根本無法知道這一點。

  • Operator

    Operator

  • Richard Vosser, JPMorgan.

    理查沃瑟,摩根大通。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Hi. Thanks for taking my question. Just a question on Itvisma. Just how should we think about the ramp of that product in the US and ex US? I could imagine that there are some patients that are potentially waiting for the therapy. So have you seen warehouse patients and how should we think about the launch? Thanks so much.

    你好。謝謝您回答我的問題。關於Itvisma,我有個問題。我們該如何看待該產品在美國及美國以外地區的市場擴張?我可以想像,可能有些患者正在等待這種治療。那麼,你們有看過倉庫病人嗎?我們該如何考慮推出?非常感謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, Richard. In general, for gene therapies, we see often a pretty fast ramp as we get through the prevalent pool of patients. And then it comes down to a more steady state. And I think over the next two to three years, we would expect really Itvisma to penetrate the majority of the relevant patient pool that it has.

    是的。謝謝你,理查。總的來說,對於基因療法而言,隨著現有患者群體的擴大,我們通常會看到療效迅速提升。然後就進入了比較穩定的狀態。我認為在接下來的兩到三年內,我們預計 Itvisma 將真正滲透到其所擁有的絕大多數相關患者群體中。

  • And then come back down as we saw with Zolgensma more to a steady state because of the nature of the one-time therapy. So I think relative to other brands, the ramp will be on the faster side. It won't be in six months, but I think over the first few years, we'll get to peak relatively quickly. And then come down from there.

    然後,就像我們在 Zolgensma 中看到的那樣,由於一次性治療的性質,藥物濃度會逐漸下降到更穩定的狀態。所以我覺得相對於其他品牌來說,這個坡道會比較快。六個月內不會達到頂峰,但我認為在最初幾年內,我們會相對迅速地達到頂峰。然後從那裡下來。

  • And we do have, I think, warehouse patients -- we do have patients that we really understand. We also have strong access, we think, in many markets. And as we build that access forward, I think that will really allow us to maximize the medicine.

    而且我認為,我們確實有一些「倉庫病人」——我們確實有一些我們真正了解的病人。我們認為,我們在許多市場也擁有強大的市場准入優勢。隨著我們不斷推進藥物獲取途徑,我認為這將真正使我們能夠最大限度地發揮藥物的作用。

  • Operator

    Operator

  • Graham Parry, Citi.

    格雷厄姆·帕里,花旗銀行。

  • Graham Parry - Analyst

    Graham Parry - Analyst

  • Great. Thanks for taking my questions. So reiterate the best wishes for Harry, of course. And then, a question on KISQALI and the outlook for the year. So how much of the gross to net impact that was impacting fourth quarter carries through into the next year because of a different channel mix versus how much is one-off? And so to what extent does that give you an easy base for comparison in 2025 into 2026? And then any thoughts you have on the risk that oral surge might pose to encroaching on CDK4/6 combinations in the adjuvant setting? Thank you.

    偉大的。謝謝您回答我的問題。當然,請再次表達對哈里的美好祝愿。然後,有人問了關於 KISQALI 以及今年的展望的問題。那麼,影響第四季毛利淨利差的因素中,有多少是因為通路組合變化而延續到下一年,又有多少是一次性因素呢?那麼,這在多大程度上能為2025年到2026年的比較提供一個簡單的基礎呢?那麼,您認為口服Surge療法可能會對輔助治療中的CDK4/6合併療法構成威脅嗎?謝謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Thanks, Graham, and great to have you back. On KISQALI, I think the higher growth in nets, we believe, is a one-time effect where we saw higher Medicare utilization than we had forecast in 2025. We do expect that the early breast cancer launch continues to accelerate and our mix shifts to younger and younger patients that this will net out back towards where we had historically expected. And I think we should be fine from that point forward.

    謝謝你,格雷厄姆,很高興你回來。關於 KISQALI,我們認為網具使用量的較高成長是一次性的,因為我們在 2025 年看到的 Medicare 使用量高於我們的預測。我們預計早期乳癌的推出將繼續加速,我們的患者群體也將越來越年輕,這最終將使我們回到過去預期的狀態。我認為從那時起我們應該就沒問題了。

  • And Harry wants to add something.

    哈里還想補充一點。

  • Harry Kirsch - Chief Financial Officer, Member of the Executive Committee

    Harry Kirsch - Chief Financial Officer, Member of the Executive Committee

  • Hi, Graham. Thank you very much. And by the way, everybody, for your nice words. So on KISQALI, I mean, one thing to note is that actually in quarter one of '25 with a positive cross to net at Mukul pointed out. So in quarter one, that's a higher base due to one-timers.

    你好,格雷厄姆。非常感謝。順便說一句,謝謝大家的鼓勵。所以關於 KISQALI,我的意思是,需要注意的一點是,實際上在 2025 年第一季度,Mukul 指出,他有一個積極的交叉球入網。所以第一季度,由於一次性交易的存在,基數較高。

  • As Vas mentioned, the quarter four, what we have noted here out of period adjustments. So if you take that out, it's really the true quarter four performance. And then the quarter four of '26, there should be a bit of a lower base because of this negative this year. But overall, the -- basically, these gross to net adjustments are all out of period. So one-timers and the underlying is what you see.

    正如 Vas 所提到的,第四季度,我們在這裡注意到的是期間調整。所以如果去掉那部分,那就是第四季的真實業績。那麼,由於今年的負面影響,2026 年第四季的基數應該會略低一些。但總的來說,這些毛利到淨利的調整基本上都不符合規定。所以,你看到的只是一次性事件和背後的真相。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • And then with respect to the oral surges, we've had a lot of discussion, and we feel confident that when we look at the profile of KISQALI and what we hear from physicians, that physicians want a CDK4/6 inhibitor for patients who can benefit. And they, of course, need to look for an endocrine therapy option.

    至於口服藥物,我們已經進行了很多討論,我們相信,當我們查看 KISQALI 的概況以及我們從醫生那裡聽到的反饋時,醫生們希望為能夠從中受益的患者提供 CDK4/6 抑製劑。當然,他們也需要尋找內分泌治療方案。

  • Certainly, the oral surge now have the opportunity over time to become the standard-of-care endocrine therapy option. We already know that roughly half of patients in the early breast cancer setting in the US are already now on a CDK4/6. And as we continue to penetrate that base of patients, we think that the opportunity will be CDK4/6 plus the choice of historical endocrine therapy or the oral surge, and that's how this market will play out.

    當然,隨著時間的推移,口服藥物現在有機會成為標準的內分泌治療方案。我們已經知道,在美國,大約一半的早期乳癌患者目前正在接受 CDK4/6 治療。隨著我們不斷拓展患者群體,我們認為 CDK4/6 抑制劑加上傳統的內分泌療法或口服衝擊療法的選擇,將是未來的發展機遇,而這正是這個市場的發展方向。

  • At the margin, could there be some physicians who choose an older endocrine therapy plus a CDK4/6 or an oral surge and not a CDK4/6? Certainly that dynamic will happen, but we don't expect that to be the predominant approach in the US or in any of the other core markets. That's what gives us confidence in the $10 billion-plus guidance that that we have and are sticking to.

    從某種程度上來說,會不會有一些醫生選擇較老的內分泌療法加上 CDK4/6 或口服衝擊療法,而不是 CDK4/6 療法?這種趨勢肯定會發生,但我們預計這不會成為美國或其他任何核心市場的主要做法。正是這一點讓我們對我們已有的、並將繼續堅持的超過 100 億美元的營收預期充滿信心。

  • Operator

    Operator

  • Seamus Fernandez, Guggenheim Securities.

    西莫斯·費爾南德斯,古根漢證券。

  • Seamus Fernandez - Equity Analyst

    Seamus Fernandez - Equity Analyst

  • Thanks very much and just would echo, Harry, we'll miss you for sure. Vas, hoping you could maybe give us your thoughts on the overall food allergy opportunity within your overall portfolio? Obviously, Xolair has done extraordinarily well in this space with excellent growth opportunity. Just hoping to get your perspective on that as well as the opportunity that you see potentially within your broader portfolio, not just for the BTK but beyond? Thanks so much.

    非常感謝,我也想再次強調,哈里,我們一定會非常想念你。Vas,能否請您談談您對食物過敏領域在您整體產品組合中的整體發展機會的看法?顯然,Xolair 在這一領域表現出色,擁有極佳的成長機會。只是想了解您對此的看法,以及您認為在您更廣泛的投資組合中可能存在的機會,不僅限於BTK,還包括其他方面?非常感謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, Seamus. We've had a long history looking at food allergy. It goes back to a medicine, some of you will remember called QGE031, which is a high affinity (inaudible) that was supposed to be a follow-on for Xolair. In the end, we weren't able to show a stronger effect than Xolair has ultimately shown in food allergies. So we know the space well.

    是的。謝謝你,西莫斯。我們長期以來一直致力於研究食物過敏問題。這要追溯到一種叫做 QGE031 的藥物,你們有些人可能還記得,它是一種高親和力(聽不清楚)藥物,原本應該是 Xolair 的後續藥物。最終,我們未能證明我們的產品在治療食物過敏方面能比 Xolair 取得更強的效果。所以我們對這區域很熟悉。

  • Once we saw the Phase 2 data for Remibrutinib and food allergy, I think it changed our perspective to really think now, how could we build this out to be a significant market opportunity? So we'll be sharing that data, as I mentioned, in the coming month or two.

    當我們看到瑞布替尼治療食物過敏的第二期臨床試驗數據後,我認為它改變了我們的觀點,讓我們開始認真思考,如何將其發展成為一個重要的市場機會?正如我之前提到的,我們將在未來一兩個月內分享這些數據。

  • And with that data set and now the agreement with FDA on how to advance into Phase 3 studies, we see the option for a safe oral medicine to be able to hopefully be given broadly to patients. And you know that a lot of the patients with the food allergies that are most interested or at risk to be treated are children. And so versus ongoing injections, having an oral high efficacy, safe option, we think would be pretty compelling.

    有了這些數據,再加上與 FDA 就如何推進 3 期研究達成的協議,我們看到了一種安全的口服藥物,預計將能夠廣泛用於患者。你知道,很多對食物過敏最感興趣或最有風險接受治療的患者都是兒童。因此,與持續注射相比,我們認為有一種口服的高效、安全的選擇會非常有吸引力。

  • So I think, overall, we see food allergy as a as a multi-billion dollar opportunity. I certainly -- with the potential to make something major out of this. We're going to, obviously, run through the Phase 3 program. We're excited to share the Phase 2 data as well.

    所以我認為,總的來說,食物過敏是一個價值數十億美元的商機。我當然相信──這有可能成就一番大事。我們顯然要執行第三階段計劃。我們也很高興與大家分享第二階段的數據。

  • And then beyond that, now we are evaluating, are there other opportunities within the pipeline earlier at Novartis? And of course, externally, as always, to see can we further bolster our food allergy portfolio? So I think it's definitely a shift, but something we're getting quite excited about.

    此外,我們現在正在評估,諾華公司早期研發管線中是否還有其他機會?當然,我們也會像往常一樣,從外部考察,看看能否進一步加強我們的食物過敏產品組合?所以我認為這絕對是一種轉變,但我們對此感到非常興奮。

  • Operator

    Operator

  • James Gordon, Barclays.

    詹姆斯·戈登,巴克萊銀行。

  • James Gordon - Equity Analyst

    James Gordon - Equity Analyst

  • Hello. James Gordon from Barclays. Thanks for taking the question. The question was on Pelacarsen and what the wind now looks like. So you talked about a potentially lower event rate, but where is the latest magnitude of efficacy parks? I think the original design was a 20% benefit in the broader population, a 25% benefit in the narrow population with a longer study and maybe some other tweaks.

    你好。巴克萊銀行的詹姆斯‧戈登。感謝您回答這個問題。問題是關於佩拉卡森山以及現在的風況。所以你提到了事件發生率可能較低,但最新的療效公園規模數據在哪裡?我認為最初的設計方案在更廣泛的人群中可帶來 20% 的益處,在更長時間的研究和一些其他調整後,在特定人群中可帶來 25% 的益處。

  • Is that still the minimum? Is there a possibility that you could actually have a benefit for either of those groups that were statistically significant, but didn't quite hit that hard? And if so, would that still be a product with strong commercial prospects?

    那還是最低標準嗎?是否有可能,對於統計學上顯著但效果並不顯著的那兩組人群,實際上會有益處?如果真是如此,那它還算是一款具有強大商業前景的產品嗎?

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, James. So you are correct. It is a 20% -- power for 20% in the 70 margin per DL group and 125% for the 90 mg per DL group. We can win on the study with a relative reduction that's lower than that. And so certainly, there is the opportunity to win with CVRR in the mid-teens.

    是的。謝謝你,詹姆斯。你說得對。對於每 DL 70 毫克組,其功效為 20%;對於每 DL 90 毫克組,其功效為 125%。我們可以透過比這更低的相對降幅在研究中獲勝。因此,CVRR 很有可能在十幾桿的成績中獲勝。

  • I think we'd have to evaluate, I think, for patients who have no other option, and if we were to win at that lower level, what would be the right approach to bring it to market? That's something we'll have to see based on the data, but that's certainly something we'd have to look at.

    我認為我們必須評估一下,對於那些別無選擇的患者,如果我們能在較低層次上取得成功,那麼將其推向市場的正確方法是什麼?這需要根據數據來判斷,但這絕對是我們必須關注的問題。

  • Of course, we hope for -- I mean, a much higher CVRR impact, either at the lower cutoff or the higher cut off, but we're going to have -- ultimately have this to be data driven. There been no other changes though from a protocol standpoint, from a study design standpoint, everything is as it was when we originally started the study with respect to powering, et cetera.

    當然,我們希望——我的意思是,無論在較低的截止值還是較高的截止值下,CVRR 的影響都要大得多,但最終我們將不得不——必須依靠數據來決定。雖然從方案角度來看沒有其他變化,但從研究設計角度來看,一切都和我們最初開始這項研究時一樣,包括樣本量等方面。

  • Operator

    Operator

  • Michael Leuchten, Jefferies.

    Michael Leuchten,傑富瑞集團。

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • Thank you. Question for Harry, please, given it's your last time with us, and thank you, Harry. The SG&A expenses in the fourth quarter were extremely tight. Very good performance there, helped you to gear the margin underlying terms.

    謝謝。請問哈利一個問題,因為這是你最後一次和我們在一起了,謝謝你,哈利。第四季銷售、管理及行政費用控制得非常嚴格。表現非常出色,幫助你調整了保證金的基本條款。

  • As I think about the margin for 2026, obviously you do have the Avidity dilution, but if that SG&A control continues, I struggle to see how you're going to get as much dilution, especially if Avidity doesn't quite close as quickly as maybe it could. So can you just talk about the repeatability of that SG&A performance in the fourth quarter into 2026?

    當我考慮 2026 年的利潤率時,顯然 Avidity 的股權稀釋確實存在,但如果 SG&A 控制繼續下去,我很難看出如何達到同樣的稀釋程度,尤其是在 Avidity 的關閉速度可能不如預期那麼快的情況下。那麼,您能否談談到 2026 年第四季銷售、管理及行政費用 (SG&A) 業績的可重複性?

  • Harry Kirsch - Chief Financial Officer, Member of the Executive Committee

    Harry Kirsch - Chief Financial Officer, Member of the Executive Committee

  • Yeah. Thank you, Michael. Actually, any 2026 question is for Mukul, so I will hand over in a second. But historically, we always had quite an increase in quarter four. So we took this year to say, look, this is inefficient to have such a peak in a quarter where you have one to two weeks of Christmas, and you have also in the US Thanksgiving, and so on. It should be actually a big peak here.

    是的。謝謝你,麥可。實際上,任何關於 2026 年的問題都應該問穆庫爾,所以我馬上把問題交給他。但從歷史數據來看,第四季我們總是會有相當大的成長。所以我們今年就指出,在一個季度內出現這樣一個高峰是不合理的,因為這個季度裡有長達一到兩週的聖誕節假期,還有美國的感恩節假期等等。這裡應該是一個很高的山峰。

  • So we took that in order to even a bit out. And overall, we will continue and Mukul, of course, will drive productivity programs, right? But Avidity, just one thing, I mean, when we -- the day before quarter three earnings, when we took you all through the Avidity deal, we said it would be a 1% to 2% margin point dilution effect, given the unusual high development cost burden in the next two to three years of a late-stage development product with a very expensive medicine from a cox, especially when it is under contract manufacturing.

    所以我們採取了措施來稍微平衡一下。總而言之,我們將繼續推進各項生產力提升計劃,當然,穆庫爾將繼續主導這些計劃,對吧?但是,關於 Avidity,有一點需要說明,我的意思是,在第三季度財報發布前一天,當我們向大家詳細介紹 Avidity 的交易時,我們說過,考慮到未來兩到三年內,後期開發產品(尤其是來自 Cox 的非常昂貴的藥物)的開發成本負擔異常高,這將導致 1% 到 2% 的合約利潤

  • So not everybody has figured this into the consensus. It's okay when people don't follow everything we say, but we have mentioned it to you. And 1 to 2 points, if you take 1.5, that's pretty much what you get when you have a low single-digit increase on sales and a low single-digit decrease in cooperating income. So we feel we have implemented exactly that. Without Avidity, it would have been unchanged margin basically. But Mukul, what do you think?

    所以並非所有人都把這一點納入了共識。別人不完全聽從我們的話也沒關係,但我們已經跟你提過了。如果以 1.5 計算,那麼 1 到 2 分就差不多是銷售額小幅成長和合作收入小幅下降時的結果了。所以我們認為我們已經完全實現了這一點。如果沒有 Avidity,利潤率基本上不會改變。穆庫爾,你怎麼看?

  • Mukul Mehta - Head of Business Planning and Analysis, Digital Finance and Tax

    Mukul Mehta - Head of Business Planning and Analysis, Digital Finance and Tax

  • Yeah. No, Harry said it all. I think it's the short answers -- the short add-ons to the answer that Harry gave was the SG&A cost control productivity plans within the organization is something that we as a company feel very proud of and what has been achieved in the last four or five years. And as we go into our next five-year journey, this will absolutely continue going forward.

    是的。不,哈利都說完了。我認為關鍵在於簡短的回答——哈里給出的答案的補充是,公司內部的銷售、一般及行政成本控制和生產力計劃是我們公司非常引以為豪的,也是過去四五年裡取得的成就。展望未來五年,我們一定會繼續這樣做。

  • There is a certain bit of margin dilution that we had predicted. And if we -- and that's the reason that we gave clarity on H1, H2, because if you look at how once the Gx for this year are going to come off the base, we actually see core operating income starting to grow. And that sets the sets the base or sets the expectations for what to expect of our P&L in the next four years to come.

    正如我們之前預測的那樣,利潤率會出現一定程度的稀釋。如果我們——這也是我們明確 H1、H2 的原因,因為如果你看看今年的 Gx 值一旦脫離基數,我們實際上會看到核心營業收入開始成長。這為未來四年我們的損益表設定了基準或預期。

  • Operator

    Operator

  • Thibault Boutherin, Morgan Stanley.

    Thibault Boutherin,摩根士丹利。

  • Thibault Boutherin - Analyst

    Thibault Boutherin - Analyst

  • Yes. Thank you. Just a question on the Cosentyx and the dynamic in the HS market. It looks like the shares have been stabilizing for some time between Cosentyx and the main competitor in terms of NDRx and total script. So from here, it's fair to assume that both drugs would grow in line with the market. And I think the (technical difficulty) used to say the agent market, we should expect a growth around 15%. So I just want to know if it's the type of growth that that you're still seeing today?

    是的。謝謝。關於Cosentyx以及HS市場的動態,我有個問題。從 NDRx 和總處方量來看,Cosentyx 與其主要競爭對手之間的股價似乎已經穩定了一段時間。因此,可以合理推斷,這兩種藥物的銷售量都會隨著市場成長而成長。我認為(技術難題)過去常說的是代理市場,我們應該預期成長約 15%。所以我想知道,你現在是否仍然看到這種成長模式?

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks for the question, Thibault. So you rightfully point out, we've seen stabilization in the overall NBRx share in the market. As I noted, we're in this 48% to 50% range, and then we see the two other medicines splitting the remainder. We're doing very well in the naive population. And then in the switch segment, we see our competitors performing very well.

    是的。謝謝你的提問,蒂博。正如您所指出的,我們已經看到 NBRx 在市場中的整體份額趨於穩定。正如我所指出的,我們目前處於 48% 到 50% 的範圍內,然後我們看到另外兩種藥物瓜分了剩餘的部分。我們在一般人群中表現非常出色。在交換機領域,我們看到競爭對手錶現非常出色。

  • So I think that's kind of the dynamic. We've seen that dynamic stabilized now, so we would expect that dynamic to continue going forward. So I think both -- all brands will grow based on the market. Now, clearly, the market potential here is quite large. It's just a matter of how effective we are at getting patients to come in to get treatment.

    所以我覺得這就是目前的動態。我們已經看到這種動態趨於穩定,因此我們預計這種動態將在未來繼續下去。所以我認為所有品牌都會根據市場情況而發展。顯然,這裡的市場潛力相當大。關鍵在於我們如何有效地讓患者前來接受治療。

  • So we continue to see this $3 billion to $5 billion market opportunity, but could it be larger if we were able to mobilize with two competitors and potentially more future competitors coming in the market growing faster? Certainly. And we, of course, want to capitalize on that. And that's part of the reason why we study Rhapsido in HS because we see the opportunity here to build this market, hopefully with a high efficacy safe oral to then go make the market even larger. So something we'll continue to work to build and hopefully get more of these patients who are lost to treatment, probably, we're on a TNF ultimately not successful, get those patients back into the medical home and back on therapy.

    因此,我們繼續看到這個價值 30 億至 50 億美元的市場機會,但如果我們能夠與兩家競爭對手以及未來可能更多快速成長的競爭對手一起行動,這個機會是否會更大呢?當然。我們當然希望利用這一點。這也是我們在高中研究 Rhapsido 的部分原因,因為我們看到了建立這個市場的機會,希望能夠開發出高效安全的口服藥物,從而進一步擴大市場。所以我們會繼續努力建設,希望能夠幫助更多那些因治療失敗而失去治療的患者(我們可能最終在 TNF 治療方面沒有取得成功),讓他們回到醫療機構並重新接受治療。

  • Operator

    Operator

  • (Operator Instructions) James Quigley, Goldman Sachs.

    (操作說明)詹姆斯·奎格利,高盛。

  • James Quigley - Analyst

    James Quigley - Analyst

  • Great. Thank you for taking my questions and my thanks and congrats to Harry as well for the next chapters. My question's on the LPA portfolio. So as you showed in the slide, you're starting a new trial, a Phase 2 trial for DII235. Firstly, what are the dosing intervals are you going to be testing for that drug?

    偉大的。感謝您回答我的問題,也請代我向哈利表達感謝和祝賀,祝他接下來的章節一切順利。我的問題是關於LPA投資組合的。正如你在幻燈片中所展示的那樣,你們正在啟動一項新的試驗,即 DII235 的 2 期試驗。首先,你們打算測試該藥物的給藥間隔是多少?

  • And secondly, at the meeting management event, as you were saying that if HORIZON were positive, that could then lead a decision to move some of the longer acting LPLA straight into Phase 3. So are there other assets in the portfolio that you're holding back waiting for HORIZON to move into Phase 3? Is this Phase 2 a function of a push out in HORIZON? Or is it just you want to see more data beforehand before making a final decision here on which assets to take forward?

    其次,在會議管理活動中,正如您所說,如果 HORIZON 試驗結果是正面的,那麼可能會決定將一些作用時間較長的 LPLA 直接推進到第三階段。那麼,您的投資組合中是否還有其他資產,您正等待 HORIZON 進入第三階段後再進行投資?第二階段是否是 HORIZON 計畫擴展的結果?或者,您只是想在最終決定要收購哪些資產之前,先查看更多數據?

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, James. So for DII235, our partner, Argo Biosciences, I think, publicly released that this has had already strong data in the early Phase 2 study and has a potential for an annual dosing interval. And we are prepared to move that study, that program directly into Phase 3 based on the HORIZON data set. So there's no change in our plan.

    是的。謝謝你,詹姆斯。對於 DII235,我們的合作夥伴 Argo Biosciences 已經公開表示,該藥物在早期 2 期研究中已經獲得了強有力的數據,並且有可能實現每年一次的給藥間隔。我們已準備好根據 HORIZON 資料集,將這項研究、該專案直接推進到 3 期。所以我們計劃沒有改變。

  • I don't know, there might be different things happening between our studies and their studies and et cetera. But our strategy very much is based on the HORIZON readout so then based on the data we've seen with DII235 on an annual dosing interval to move that forward then into late stage studies.

    我不知道,我們的研究和他們的研究之間可能存在一些不同之處等等。但我們的策略很大程度上是基於 HORIZON 試驗的結果,然後根據我們從 DII235 獲得的年度給藥間隔數據,推進到後期研究階段。

  • We do have, of course, a range of other programs earlier stage, as well on a range of cardiovascular assets. We've talked about that in the past, HMG-CoA reductase, annual PCSK9, of course, the (inaudible) SIRNA. And then combination programs as well that we're working on both at the six-month interval and at the one-year interval.

    當然,我們還有一系列其他處於早期階段的項目,以及一系列心血管資產項目。我們過去也討論過 HMG-CoA 還原酶、年度 PCSK9,當然還有(聽不清楚)SIRNA。此外,我們也正在研究以六個月為間隔和以一年為間隔的組合方案。

  • And so both because we need the life cycle manage Leqvio, but also be prepared that if Pelacarsen's positive. So the HORIZON positive to be able to be ready to come with what we think will be the preferred market option, we want to be ready for all these eventualities.

    因此,一方面是因為我們需要管理 Leqvio 的生命週期,另一方面也是因為要做好準備,以防 Pelacarsen 檢測結果呈現陽性。因此,HORIZON 的積極之處在於,我們能夠做好準備,提出我們認為最受市場歡迎的選擇,我們希望為所有這些可能的情況做好準備。

  • Operator

    Operator

  • Peter Verdult, BNP Paribas.

    Peter Verdult,法國巴黎銀行。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Yeah. Thanks. Peter Verdult, BNP. Just a follow-up for you, Vas, on the pipeline. Just on this basket of self-therapy programs in autoimmune, I think some of them do read out next year. Just wondering if you've got it in the top of your head in terms of which ones, which indications and perhaps a general temperature check on your behalf in terms of your level of enthusiasm for these programs? Thank you.

    是的。謝謝。Peter Verdult,英國國家黨。Vas,關於管道方面,我還有一個後續問題想跟你確認。就這一系列自體免疫疾病的自我治療方案而言,我認為其中一些方案明年就會推出。我只是想知道你是否已經大致了解了哪些項目、哪些指標,以及你對這些項目的熱情程度?謝謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, Peter. We remain enthusiastic. We have a huge effort internally on YTB as the first instance. Currently in pivotal studies aligned with FDA over four indications, and then with follow-on programs that are now in proof of concept studies in three -- four additional indications as well. And then just additional exploratory work that's ongoing. And then behind that, tri-specific and bi-specific monoclonals also to explore, can there be alternative options for certain patient groups in the immune reset?

    是的。謝謝你,彼得。我們依然充滿熱情。我們內部在 YTB 上投入了大量精力,將其作為首要目標。目前,該藥物正與 FDA 合作進行四項適應症的關鍵性研究,隨後進行的後續計畫目前也正在進行三到四項其他適應症的概念驗證研究。此外,還有一些正在進行中的探索性工作。此外,還可以探索三特異性和雙特異性單株抗體,看看能否為免疫重置中的某些患者群體提供替代方案?

  • I think the first readouts we'll have will be in SLE lupus nephritis. That's building off of the data we presented last year on 23 or 24 patients where we showed, I think, pretty spectacular results for those patients in terms of rewinding the progress of their disease other than the permanent damage that had happened to the kidneys. And so quite exciting data. That's allowed us, I think, to move forward on that study quite quickly.

    我認為我們首先會得到SLE狼瘡性腎炎的診斷結果。這是基於我們去年公佈的關於 23 或 24 名患者的數據,我認為,這些數據表明,除了腎臟遭受的永久性損傷之外,這些患者在逆轉疾病進展方面取得了相當驚人的成果。所以,這些數據相當令人興奮。我認為,這使我們能夠很快地推進這項研究。

  • But we also are advancing all the other programs. And some of them, if we're fortunate, might even be able also to read out next year depending on enrollment patterns and enrollment timelines. So we're advancing these as fast as possible.

    但我們也正在推進其他所有項目。如果運氣好的話,其中一些甚至可能在明年也能預測出來,這取決於招生模式和招生時間表。所以我們正在以最快的速度推進這些工作。

  • Depending on the program, many of them have alignment with FDA that we can file off of a single arm and then continue on to provide data on randomized data sets. Others need the randomized up front, so that all varies based on indication, but I think a lot of the enthusiasm and focus inside the company.

    根據計畫的不同,其中許多項目都與 FDA 有合作關係,我們可以根據單一試驗組的數據提交申請,然後繼續提供隨機數據集的數據。其他人則需要提前進行隨機分組,因此一切都取決於適應症,但我認為公司內部的熱情和專注度很大程度上源於此。

  • Operator

    Operator

  • Michael Leuchten, Jefferies.

    Michael Leuchten,傑富瑞集團。

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • Thank you for the follow-up. Last, just on SCEMBLIX. You helpfully provide the shared data across lines of therapy for the product. It looks like it's plateauing in first line in the US a little bit over the last few quarters. What's stopping the momentum to continue?

    感謝您的後續跟進。最後,就SCEMBLIX而言。您提供了該產品各治療方案之間的共享數據,這很有幫助。過去幾個季度,美國一線市場似乎出現了一些停滯現象。是什麼阻礙了這種勢頭繼續下去?

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • Yeah. Thanks, Michael. So we have looked into that. One thing to note is the data is very noisy because with CML, it's a rare disease, most physicians only see one or two patients. And so the data here always is getting restated.

    是的。謝謝你,麥可。我們已經調查過了。需要注意的是,由於 CML 是一種罕見疾病,大多數醫生只會遇到一到兩名患者,因此數據雜訊很大。因此,這裡的數據總是不斷地被重新表達。

  • Overall, our view, based on our internal assessments as we continue to see steady share growth on the frontline setting, actually I would say our frontline share growth is ahead of our plan and our original planning assumptions. And so we see the opportunity here to really continue to grow. We have really strong broad access.

    總體而言,根據我們的內部評估,隨著我們在一線市場持續看到穩定的份額增長,我們的觀點是,實際上,我認為我們的一線市場份額增長已經超過了我們的計劃和最初的規劃假設。因此,我們看到了繼續發展壯大的機會。我們擁有非常強大的廣泛影響力。

  • One of the biggest things we're trying to overcome is the perception that we don't have strong access to get that access perception to where we want it to be. And then of course as we've outlined in the past, you do have believe back loyalists out there who want to stay with a product that they've used for a long period of time. That will be more of a refractory group, but to get from the mid-20s up to the 40% to 50% share range is absolutely what our ambition is, and we see a path to get there.

    我們正在努力克服的最大問題之一是,人們認為我們沒有足夠的資源來改變這種資源獲取的觀念,使其達到我們想要的水平。當然,正如我們過去所概述的那樣,確實有一些忠實擁躉,他們希望繼續使用自己長期使用的產品。那將是一個比較難搞的群體,但我們的目標絕對是將市場份額從 20% 左右提升到 40% 到 50% 之間,而且我們看到了實現這一目標的途徑。

  • Next question, or I think this might be the last question, operator?

    下一個問題,或者說這可能是最後一個問題了,接線生?

  • Operator

    Operator

  • James Quigley, Goldman Sachs.

    James Quigley,高盛集團。

  • James Quigley - Analyst

    James Quigley - Analyst

  • Hello. Thank you for taking the follow-up. I've got one quick one on zigakibart. The date's been pushed out a little bit in order to have the eGFR data on the label at launch. But as you think about the strategy here with your other assets, whether you have the UPCR data first and then adding the eGFR data, is this a case that the data were quite close together so it was worth having a having a delay? Just trying to understand the rationale here versus the other mechanism. Or is there something around the zigakibart mechanism that could lead to a stronger benefit on eGFR relative to UPCR? Thank you.

    你好。感謝您跟進。我這裡有一個關於zigakibart的簡短問題。為了在產品上市時將 eGFR 數據標註在標籤上,上市日期稍微延後了一些。但是,當您考慮將這種策略與其他資產結合時,如果您先獲得 UPCR 數據,然後再添加 eGFR 數據,那麼這些數據是否非常接近,以至於值得延遲一段時間?我只是想弄清楚這裡採用的機制與其他機制有何不同。或者,zigakibart 機制是否存在某種因素,可以對 eGFR 產生相對於 UPCR 的更大益處?謝謝。

  • Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

    Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee

  • It's a great question, James. I think when we looked at the number of competitors entering in the anti-(inaudible) space, we asked ourselves, given we already have a strong portfolio in the nephrologist's office, what would give us the most compelling data package to cut through all of the various launches that are ongoing? And we felt coming right away with hopefully the second medicine with a full approval, clear proteinuria reduction and eGFR benefit would give us a very compelling proposition.

    詹姆斯,你問得好。我認為,當我們審視進入抗(聽不清楚)領域的競爭對手數量時,我們問自己,鑑於我們已經在腎臟科醫生的診室裡擁有強大的產品組合,什麼才能為我們提供最有說服力的數據包,從而在所有正在進行的各種產品發布中脫穎而出?我們當時覺得,如果能立即推出第二款獲得全面批准、能明顯減少蛋白尿並改善 eGFR 的藥物,將會為我們帶來非常有吸引力的方案。

  • I mean, theoretically, assuming everything goes as we hope, we would have three medicines in IgAN with eGFR outcomes benefit across Fabhalta, Vanrafia, and zigakibart. And that would give us a very compelling proposition. So we thought that was prudent given that the time that passes here is three quarters. It's not the end of the world, and then we would have a much more compelling data set to provide to FDA.

    我的意思是,理論上講,假設一切都如我們所願,那麼在 IgAN 治療中,我們將有三種藥物可以改善 eGFR 結果,分別是 Fabhalta、Vanrafia 和 zigakibart。這將給我們一個非常有吸引力的建議。鑑於這裡的時間流逝速度是四分之三,我們認為這樣做是謹慎的。這並非世界末日,而且那樣我們就能向FDA提供更有說服力的數據集。

  • All right. Well, thank you all very much for joining the conference call. We look forward to keeping you up to speed and we wish you all a great 2026. Thank you.

    好的。非常感謝各位參加電話會議。我們期待繼續向您報告最新情況,並祝福大家2026年一切順利。謝謝。

  • Operator

    Operator

  • Thank you. This concludes today's conference call. Thank you for participating and you may now disconnect.

    謝謝。今天的電話會議到此結束。感謝您的參與,您現在可以斷開連接了。