使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning and good afternoon, and welcome to the Novartis Q3 2025 results release conference call And live webcast. (Operator Instructions) The conference is being recorded. (Operator Instructions)
早安,下午好,歡迎參加諾華2025年第三季業績發布電話會議和網路直播。(操作員指示)會議正在錄音。(操作說明)
A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. With that, I would like to hand over to Ms. Sloan Simpson, Head of Investor Relations.
會議結束後不久,我們將在網站上提供本次電話會議的錄音,包括問答環節的錄音。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。
Please go ahead, madam
請繼續,女士
Sloan Simpson - Head of Investor Relations
Sloan Simpson - Head of Investor Relations
Thank you, Sharon. Good morning and good afternoon, everyone, and welcome to our Q3 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.
謝謝你,莎倫。各位早安/下午好,歡迎參加我們2025年第三季財報電話會議。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。請參閱公司向美國提交的 20-F 表格。
Securities and Exchange Commission for a description of some of these factors. The discussion today is not the solicitation of a proxy nor any -- nor an offer of any kind with respect to the securities of Avidity Biosciences or SpinCo.
有關其中一些因素的描述,請參閱美國證券交易委員會的說明。今天的討論並非徵集代理權,也不是就 Avidity Biosciences 或 SpinCo 的證券提出任何形式的要約。
The parties intend to file 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.
雙方打算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 want to reiterate to our analysts, please limit yourselves to one question at a time, and we'll cycle through the queue as needed.
在正式開始之前,我想再次提醒各位分析師,請你們一次只提一個問題,我們會根據需要輪流提問。
And with that, I will hand over to Vas.
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
Great. Thank you, Sloan, and thanks, everybody, for joining today's conference call. If you turn to slide 5, Novartis delivered solid sales and core operating income growth. And I think importantly for us, important pipeline milestones through quarter three. Sales were up 7%.
偉大的。謝謝斯隆,也謝謝各位參加今天的電話會議。如果您翻到第 5 張投影片,諾華公司實現了穩健的銷售額和核心營業收入成長。我認為對我們來說更重要的是,第三季將迎來重要的專案里程碑。銷售額成長了7%。
Core operating income was up 7% with our core margin at 39.3%. And in the quarter, we were able to deliver some important approvals, including Rhapsido, our FDA approval in CSU for our BTK inhibitor. As well as important Phase III results, which we'll go through in a bit more detail, Ianalumab, Pluvicto, Kisqali's five-year data as well as positive opinions for Scemblix and then also positive data that came out relatively recently on Cosentyx in PMR and Fabhalta in IgAN.
核心營業收入成長7%,核心利潤率為39.3%。本季度,我們取得了一些重要的審批結果,包括 Rhapsido,這是我們在科羅拉多州立大學獲得的 FDA 批准的 BTK 抑制劑。除了重要的 III 期臨床試驗結果(我們將在後面詳細介紹)之外,還有 Ianalumab、Pluvicto、Kisqali 的五年數據,以及 Scemblix 的積極評價,還有最近公佈的 Cosentyx(用於治療 PMR)和 Fabhalta(用於治療 IgAN)的積極數據。
Now moving to slide 6. Our priority brands drove robust growth in the quarter. So I think really, while we, of course, are contending with our LOEs that particularly Entresto, but also Tasigna and Promacta, what I hope we can get the focus to be on is on our strong underlying growth of our key growth drivers.
現在進入第6張投影片。我們的重點品牌在本季實現了強勁成長。所以我覺得,雖然我們當然要處理 LOE 的問題,特別是 Entresto,還有 Tasigna 和 Promacta,但我希望我們能夠把重點放在我們關鍵成長驅動因素的強勁潛在成長上。
Here, you can see growing 35%, really excellent performance from Kisqali, Kesimpta, Pluvicto, Scemblix, solid performance from Leqvio and Fabhalta. So I think we're on a solid track to drive growth through the coming years.
在這裡,你可以看到成長了 35%,Kisqali、Kesimpta、Pluvicto、Scemblix 的表現非常出色,Leqvio 和 Fabhalta 的表現也很穩健。所以我認為我們正走在穩步發展的道路上,未來幾年將持續成長。
Now moving to slide 7. Now taking each brand in turn, Kisqali grew 68% in quarter three, outpacing the market and our CDK4/6 competition.
現在轉到第7張投影片。現在逐一分析各個品牌,Kisqali 在第三季成長了 68%,超過了市場和我們的 CDK4/6 競爭對手。
If I could draw your attention to the center panel, our total to brand NBRx now, as you can see, is in a market-leading position, particularly driven by the early breast cancer launch. Our US growth was up 91% in quarter three. We are the metastatic breast cancer leader in NBRx and TRx. And in early breast cancer, our share is 63%, and we're leading both in the overlapping populations with our competitor and the exclusive population.
如果您能注意一下中間的面板,正如您所看到的,我們目前對品牌 NBRx 的總投入處於市場領先地位,這主要得益於早期乳癌產品的上市。第三季度,我們在美國的成長率為 91%。我們在轉移性乳癌的 NBRx 和 TRx 領域處於領先地位。在早期乳癌領域,我們的市佔率為 63%,無論是在與競爭對手重疊的人群中,還是在專屬人群中,我們都處於領先地位。
In particular, I see -- I'd say we see significant growth potential in that exclusive population where we estimate more than 60% of patients are currently not on a CDK4/6 inhibitor. Outside of the US, we saw 37% growth in constant currency. We are the NBC leader in NBRx and TRx share across our key markets.
尤其是,我認為——可以說,我們看到了這部分特殊人群的巨大成長潛力,據估計,目前超過 60% 的患者沒有接受 CDK4/6 抑制劑治療。美國以外地區的經濟成長率為 37%(以固定匯率計算)。我們在主要市場的 NBRx 和 TRx 份額方面均處於 NBC 領先地位。
Our early breast cancer indication now is approved in 56 countries. And so we'll start to see the effect of the early breast cancer launch in the next few quarters ex US
我們的早期乳癌適應症目前已在56個國家獲得批准。因此,我們將在未來幾季(除美國以外)開始看到早期乳癌防治產品上市的效果。
Now I think it's a good indicator of what we see as possible outside the United States. Our Germany NBRx share is already at 77%. And I think that helps demonstrate the kind of power that we have to drive Kisqali's utilization and enable women to prevent breast cancer recurrence across the globe.
現在我認為這很好地表明了我們認為美國以外地區可能出現的情況。我們在德國 NBRx 的份額已經達到 77%。我認為這有助於展現我們擁有的力量,可以推動 Kisqali 的使用,並使世界各地的女性能夠預防乳癌復發。
I'll close by just reminding you, we have a Category 1 NCCN guideline support as the only preferred CDK4/6 inhibitor with the highest score in early breast cancer and metastatic breast cancer.
最後我還要提醒大家,我們的產品獲得了 NCCN 指南 1 類支持,是唯一在早期乳癌和轉移性乳癌治療中評分最高的首選 CDK4/6 抑制劑。
Now moving to slide 8. Just wanted to say a word about Kisqali's five-year data, which we showed at ESMO. There was a 28.4% reduction in the risk of recurrence in the broadest population of early breast cancer patients that have been studied.
現在進入第8張投影片。我只想簡單提一下我們在 ESMO 上展示的 Kisqali 五年數據。在所研究的最廣泛的早期乳癌患者群體中,復發風險降低了 28.4%。
You can see here the data is very consistent across tumor Stage 2 or Stage 3 in node-negative patients and node-positive patients. I'd also note that our OS data, while still maturing, has reached a hazard ratio of 0.8, and we see a narrowing confidence interval, as you can see here in the third bullet, just a little bit above 1 on the upper bound of the confidence interval. So a clear trend favoring Kisqali.
從這裡可以看出,在淋巴結陰性患者和淋巴結陽性患者中,腫瘤分期為第 2 期或第 3 期的數據非常一致。我還要指出,我們的作業系統資料雖然仍在完善中,但風險比已達到 0.8,而且我們看到置信區間正在縮小,正如您在第三點中看到的那樣,置信區間的上限略高於 1。所以,基斯卡利明顯佔優。
The safety is consistent. We also had some notable important trends in the data continue to demonstrate a reduction in distant recurrence to distant metastases, which is excellent to see. So we'll continue to follow these patients and continue to provide updates on this data as it matures.
安全性始終如一。我們也發現一些值得注意的重要趨勢,數據顯示遠端復發和遠端轉移的發生率持續下降,這令人欣喜。因此,我們將繼續追蹤這些患者,並隨著數據的成熟繼續提供最新資訊。
Now moving to slide 9. Kesimpta grew 44% in quarter three, and this was primarily demand-driven growth, particularly in the United States. US, we had 45% growth in Q3, robust TRx growth outpacing both the MS and B-cell markets. We have broad first-line access now almost 80% of the patients receiving Kesimpta are first line or first switch. Outside of the US, we had 43% growth, and we're the leader in NBRx share in 8 out of the 10 major markets that we participate in.
現在轉到第9張投影片。Kesimpta 第三季成長了 44%,這主要是由需求驅動的成長,尤其是在美國。在美國,我們第三季實現了 45% 的成長,強勁的 TRx 成長超過了 MS 和 B 細胞市場。我們現在擁有廣泛的第一線用藥管道,在接受 Kesimpta 治療的患者中,近 80% 是一線用藥或首次轉換用藥。在美國以外,我們的成長率為 43%,在我們參與的 10 個主要市場中,有 8 個市場的 NBRx 份額位居領先地位。
And we see a significant opportunity now looking ahead for Kesimpta outside of the US, where approximately 70% of disease-modifying treated patients are not currently being treated with a B-cell therapy.
展望未來,我們看到 Kesimpta 在美國以外地區擁有巨大的發展機遇,因為目前約有 70% 的疾病改善治療患者尚未接受 B 細胞療法治療。
So as we continue to get that B-cell class up with Kesimpta having leading share in many markets, we see the opportunity to drive dynamic growth ex US We did present some additional data at ECTRIMS that show the benefit of Kesimpta. I think I'd highlight that 90% of naive patients receiving Kesimpta showed no evidence of disease activity at seven years, really demonstrating the durability of the response to this medicine.
因此,隨著我們不斷提高 B 細胞水平,Kesimpta 在許多市場佔據領先地位,我們看到了在美國以外地區推動動態成長的機會。我們在 ECTRIMS 上展示了一些額外的數據,顯示了 Kesimpta 的優勢。我想強調的是,接受 Kesimpta 治療的初治患者中有 90% 在七年後沒有出現疾病活動跡象,這真正證明了這種藥物療效的持久性。
Now moving to slide 10. Pluvicto grew 45% in constant currencies in quarter three. That's really momentum driven off of the pre-taxane castrate-resistant prostate cancer approval, which we recently achieved. The US growth is driven -- so the Q3 sales in the US were up 53%, driven by new patient starts increasing to 60% versus prior year.
現在轉到第10張投影片。Pluvicto 第三季以固定匯率計算成長了 45%。這其實是得益於我們最近獲得的去勢抵抗性前列腺癌藥物(紫杉烷類藥物)的批准。美國市場的成長是由新患者數量增加所驅動的——因此,第三季度美國銷售額增長了 53%,這主要得益於新患者數量較上年同期增長了 60%。
60% of our new patients in the pre-taxane setting are -- with market share already surpassing chemotherapy. So really driven now by the pre-taxane launch. The key enablers to sustain our growth now in the US is really to drive community adoption. We have 60% of our TRx in the community.
在接受紫杉烷類藥物治療之前,我們新患者中有 60% 是——市場份額已經超過了化療。所以現在真正的驅動力是上市前的抗癌藥物。目前,我們在美國保持成長的關鍵在於推動社區的採納。我們60%的交易量來自社區。
We have 9 out of 10 patients within 30 miles of a treating site, so over 730 sites. We believe that we need to get to around 900 sites to also support the HSPC indication. So we're well on our way. Our rollout of the pre-filled syringe is really positive, around 70% of sites using the pre-filled syringe already. And outside of the US, the rollout continues.
我們有十分之九的患者居住在距離治療地點 30 英里以內的地方,因此治療地點超過 730 個。我們認為,我們需要達到大約 900 個站點才能支持 HSPC 適應症。所以我們已經走在正確的道路上了。我們推廣預充式註射器的效果非常好,大約 70% 的站點已經在使用預充式註射器。在美國以外,推廣工作仍在繼續。
We see good growth in the post-taxane setting in Europe, Canada, and Brazil. And we also received a Japan approval and expect the China approval in quarter four. So all on track for Pluvicto to reach its peak sales potential.
我們看到歐洲、加拿大和巴西的後紫杉烷類藥物市場呈現良好成長動能。我們也獲得了日本的批准,預計將在第四季度獲得中國的批准。因此,Pluvicto 正按計劃朝著銷售巔峰邁進。
Now moving to slide 11. We presented last week the PSMAddition data, where we demonstrated that Pluvicto plus standard of care reduced the risk of progression or death for standard of care alone by 28%.
現在轉到第11張投影片。我們上週公佈了 PSMAddition 數據,其中我們證明,與單獨接受標準治療相比,Pluvicto 加標準治療可降低疾病進展或死亡風險 28%。
The primary endpoint was met, clinically meaningful 28% reduction in these patients with a compelling p-value, a clear positive trend in OS with a hazard ratio of 0.84, and that's even with crossover.
主要終點已達到,這些患者的臨床意義顯著降低了 28%,p 值令人信服,總生存期 (OS) 呈現明顯的積極趨勢,風險比為 0.84,即使存在交叉治療也是如此。
So I think that really demonstrates we're having the attended effect the time to progression to castrate-resistant prostate cancer was delayed, which demonstrates we are achieving disease control. And overall, the Pluvicto tolerability profile was consistent with the Phase III trials in PSMAfore and VISION. So we would see global regulatory submissions in quarter four of this year.
所以我認為這確實表明我們正在取得預期的效果,即進展為去勢抵抗性前列腺癌的時間被延緩了,這表明我們正在實現疾病控制。整體而言,Pluvicto 的耐受性與 PSMAfore 和 VISION 的 III 期試驗結果一致。因此,我們將在今年第四季看到全球監管的申報文件。
So moving to slide 12. Leqvio was up 54% in the quarter, on track for over $1 billion in sales in the year. In the US, we're up 45%, outpacing the advanced lipid-lowering market. We had solid TRx gains of 44% versus prior year. And our key focus is particularly in Part B accounts and accounts that have a high interest, of course, in using the buy-and-bill Leqvio model to drive more depth in those accounts, particularly as we've now evolved our field model to better support those accounts. Outside of the US, we see a continued strong performance, 63% growth.
接下來是第12張投影片。Leqvio 本季成長 54%,預計全年銷售額超過 10 億美元。在美國,我們的銷售額成長了 45%,超過了先進降血脂藥物市場的成長速度。與前一年相比,我們的交易量 (TRx) 實現了 44% 的穩健成長。當然,我們的重點尤其在於 B 部分帳戶和對使用 Leqvio 的「買入和結算」模式有濃厚興趣的帳戶,以便更深入地了解這些帳戶,尤其是在我們現在已經改進了現場模式以更好地支援這些帳戶的情況下。除美國以外,我們看到業績持續強勁成長,成長 63%。
driven by a number of markets, particularly China out of pocket, but we also see strong uptake in Japan, strong uptake in the Middle East and the Gulf countries. So all of that taken together, I think, really portends well for Leqvio in the medium to long term. We did achieve some important regulatory and clinical trial highlights. Our US monotherapy label expansion, removing the statin prerequisite in the primary prevention population was added to the label.
受多個市場(尤其是中國)的推動,我們也看到日本、中東和海灣國家的強勁需求。綜上所述,我認為,這對 Leqvio 的中長期發展來說確實是一個好兆頭。我們在監管和臨床試驗方面取得了一些重要的進展。我們擴大了美國單藥治療標籤範圍,取消了一級預防人群中服用他汀類藥物的先決條件,並將此內容添加到標籤中。
The V-DIFFERENCE data was presented at ESC, which showed Leqvio helps patients get to goal faster. I'd also note that our pediatric submissions are on track, which, of course, supports our longer-term LOE profile.
V-DIFFERENCE 數據已在 ESC 上公佈,數據顯示 Leqvio 可幫助患者更快地達到治療目標。我還要指出,我們的兒科申請進展順利,這當然也支持了我們長期的LOE(成果展示)概況。
Now moving to slide 13. Scemblix grew 95% in constant currencies in quarter three. It's on track to be the most prescribed TKI by NBRx in the US focusing on the middle panel, you can see that our all line of therapy, NBRx has now reached 39% and is steadily climbing built off of that first-line approval. In first line specifically, we've reached 22% share. So we're now approaching NBRx leadership in first line.
現在轉到第13張投影片。Scemblix 第三季以固定匯率計算成長了 95%。它有望成為美國 NBRx 公司處方量最大的 TKI,重點關注中端患者群體,你可以看到,我們全線療法 NBRx 的處方量現在已經達到 39%,並且隨著一線療法獲批,其處方量還在穩步攀升。具體來說,在第一行,我們已經達到了 22% 的市佔率。所以我們現在正朝著 NBRx 的一線領導層邁進。
We already are the NBRx leader in second line and third line plus with 52% and 53% share, respectively. Outside of the US, our focus currently is on the third line plus setting, where we have 68% share.
我們在二線和三線及以上藥品市場中已分別佔據 52% 和 53% 的市場份額,是 NBRx 的領導者。在美國以外,我們目前的重點是三線及以上市場,我們在該市場佔有 68% 的份額。
But we do have the early line now approved in 26 countries, including China and Japan and a positive CHMP recommendation from October. So we would expect now to start to see our ability to reach patients in the first-line setting picking up outside of the United States. As an indicator of that, you can see here our strong launch momentum in Japan, first-line share already up to 18%, second line at 25%. So we continue to be very optimistic about the outlook for Assembly.
但目前我們的早期療法已在包括中國和日本在內的 26 個國家獲得批准,並且 10 月獲得了 CHMP 的積極推薦。因此,我們預計現在我們將開始看到我們在美國以外的地區接觸第一線患者的能力有所提高。從這裡可以看出,我們在日本的強勁上市勢頭,一線市佔率已達 18%,二線市佔率達 25%。因此,我們對 Assembly 的前景仍然非常樂觀。
Then moving to slide 14. Now Cosentyx had a mixed quarter. Our growth was impacted by a onetime effect in quarter three, which I'll go through in a moment. But most importantly, we remain on track for mid-single-digit growth in full year 2025 and are confident in the peak sales potential of the brand. So you can see that in constant currencies, our growth was down 1%.
然後轉到第 14 張投影片。Cosentyx本季業績喜憂參半。第三季我們的成長受到一次性事件的影響,我稍後會詳細說明。但最重要的是,我們仍有望在 2025 年全年實現個位數中段的成長,並且對該品牌的銷售高峰潛力充滿信心。因此,以固定匯率計算,我們的成長率下降了 1%。
In US dollars, we're more or less flat. Now when you remove the onetime RD adjustment of $74 million, our global sales growth was around 4% in constant currencies. In the US, when we adjust for that onetime RD, our growth goes from plus 1% to plus 9%. Cosentyx continues to be the number one prescribed IL-17 across indications.
以美元計,我們基本上持平。如果扣除一次性研發調整 7,400 萬美元,以固定匯率計算,我們的全球銷售額成長率約為 4%。在美國,當我們調整掉那一次研發投入後,我們的成長率從 +1% 變成 +9%。Cosentyx 仍然是各種適應症中處方量最高的 IL-17 藥物。
In HS, now we see a stabilization of the performance, 52% share in naive and 50% overall. So when the competitor came in, we did see a dip in that share, but that's now stabilized. And we are better able now to manage patients alongside physicians to achieve step-up dosing rather than switching off of Cosentyx. And I think that will be important. And so we can really turn our focus to market expansion in HS with the stable share that we've been able to achieve.
在高中,現在我們看到績效趨於穩定,樸素型學生佔 52%,總體佔 50%。所以當競爭對手進入市場時,我們確實看到市佔率有所下降,但現在已經穩定下來了。我們現在能夠更好地與醫生一起管理患者,實現劑量遞增,而不是停止服用可善挺。我認為這很重要。因此,憑藉我們已經取得的穩定市場份額,我們可以真正將注意力轉向HS市場的擴張。
Outside of the US, we were down 3% in constant currencies, but this again was driven by a onetime price effect in the prior year. Importantly, we saw 4% volume growth, and we're the leading originator biologic in Europe and China.
除了美國以外,以固定匯率計算,我們下降 3%,但這同樣是由前一年的一次性價格效應造成的。重要的是,我們的銷量成長了 4%,而且我們是歐洲和中國領先的生物製劑原廠藥生產商。
So overall, I think the key message is we're confident in the $8 billion peak sales potential. We expect continued market growth in our core indications and rollout of the recent launches in HS and IV. But I think also importantly, we did achieve a positive Phase III readout in polymyalgia rheumatica.
所以總的來說,我認為關鍵訊息是我們對80億美元的銷售高峰潛力充滿信心。我們預期核心適應症的市場將持續成長,最近在HS和IV領域推出的產品也將陸續上市。但我認為同樣重要的是,我們在風濕性多肌痛的 III 期臨床試驗中取得了積極的結果。
It's the second most common inflammatory disease in adults over 50, an estimated 800,000 patients in the US and 1 million patients in Europe to have the condition. So this is a market that's on par with the HS market when you think about the size of the segment.
它是 50 歲以上成年人中第二常見的發炎性疾病,據估計,美國有 80 萬名患者,歐洲有 100 萬名患者患有此病。所以,從細分市場的規模來看,這個市場與高中生市場不相上下。
We have global regulatory submissions planned in the first half of 2026, and we'll be working to accelerate them as well and really hope to drive rapid uptake in PMR. We believe the data is compelling.
我們計劃在 2026 年上半年提交全球監管申請,我們也將努力加快這些申請的進度,並真誠地希望推動 PMR 的快速普及。我們認為這些數據很有說服力。
We demonstrated, as you saw in the press release, a positive clinically meaningful primary endpoint, and we also hit all of the secondary endpoints. So we're looking forward to presenting that data and taking this launch forward.
正如您在新聞稿中看到的那樣,我們證明了具有臨床意義的主要終點是積極的,而且我們也達到了所有次要終點。因此,我們期待著展示這些數據,並推動此次發表會。
Now moving to slide 15. Our renal portfolio continues to gain traction in the US We had a positive Fabhalta eGFR data, really the first oral therapy to generate such compelling eGFR data.
現在轉到第15張投影片。我們的腎臟產品組合在美國持續獲得市場認可。 Fabhalta 的 eGFR 數據表現積極,它是第一個產生如此令人信服的 eGFR 數據的口服療法。
So looking forward to presenting that. We see steady growth in the US Our IgAN portfolio grew 98% versus market growth of 23%. Our NBRx share is now 18% climbing steadily. We see strong uptake as the first approved therapy in C3G.
非常期待向大家展示這個成果。我們在美國市場實現了穩步成長。我們的 IgAN 產品組合成長了 98%,而市場成長率為 23%。我們的 NBRx 市佔率目前穩定攀升至 18%。我們看到,作為首個獲批的 C3G 療法,該療法受到了廣泛歡迎。
Outside of the US, we're beginning to get the key approvals, particularly in China, where there's a large market for IgAN therapies. And turning to the Phase III APPLAUSE-IgAN study, we saw a statistically significant clinically meaningful improvement in eGFR slope versus placebo. It's the longest renal function data for IgAN to date. So we're excited to present that data at a future meeting. And this data should support a full approval -- traditional approval with FDA.
在美國以外,我們開始獲得關鍵的批准,尤其是在中國,對 IgAN 療法有著龐大的市場。再來看 III 期 APPLAUSE-IgAN 研究,我們發現與安慰劑相比,eGFR 斜率有統計學意義和臨床意義的改善。這是迄今IgAN患者腎功能數據最長的紀錄。所以我們很高興能在未來的會議上展示這些數據。這些數據應該能夠支持獲得全面批准——即獲得FDA的傳統批准。
Now moving to slide 16. Rhapsido was approved by FDA as the only oral targeted BTK inhibitor for CSU. I think many of you know the medicine well. It's something we're quite excited about. It's indicated for the treatment in adult patients who remain symptomatic despite antihistamine treatment.
現在轉到第16張投影片。Rhapsido 是 FDA 批准的唯一用於治療慢性自發性蕁麻疹的口服標靶 BTK 抑制劑。我想你們很多人都很了解這種藥。我們對此感到非常興奮。適用於治療儘管接受抗組織胺治療但仍有症狀的成年患者。
And we estimate that patient population to be around 400,000 patients uncontrolled out of 1.5 million treated patients. We achieved a clean safety profile with this medicine, no box warning, no contraindications, no requirements for routine lab or liver monitoring. oral administration, 25 milligrams twice daily with or without food. So a really good profile for these patients. I would want to highlight as well.
我們估計,在接受治療的 150 萬患者中,約有 40 萬名患者病情未受控制。此藥安全性良好,無黑框警告,無禁忌症,無需常規實驗室或肝功能監測。口服,每次25毫克,每日兩次,餐前或餐後服用均可。所以這些患者的資料非常好。我也想重點強調一下。
We're very excited to have a medicine with rapid onset in a highly symptomatic condition. These patients have to deal with itch, loss of sleep, discomfort. And so if you can have a medicine that has a really rapid efficacy benefit that's really, I think, something that could drive rapid uptake.
我們非常高興能研發出一種起效迅速、症狀嚴重的藥物。這些患者需要忍受搔癢、失眠和不適。因此,如果有一種藥物能夠迅速發揮療效,我認為這真的可以推動其快速普及。
Our initial patient -- physician feedback is excellent, and we're already seeing a steady increase in start forms. Our goal will be to improve the access environment for the drug as fast as possible, and then we would start -- expect to see rapid uptake over the course of next year.
我們收到的初步患者-醫生回饋非常好,而且我們已經看到註冊申請表數量穩定增加。我們的目標是盡快改善該藥物的獲取環境,然後我們就可以開始——預計在明年將看到快速的普及。
And then lastly, in both EU and China, we've completed our submissions and our Japan submission is slated for also later this year. And moving to the next slide. Ianalumab, we announced our positive Phase III studies earlier in the quarter. Yesterday, we released our top line data. The full data set will be presented soon, I think, tomorrow.
最後,我們在歐盟和中國的申請都已完成,日本的申請也計劃在今年稍後提交。接下來是下一張投影片。我們在本季度早些時候宣布了 Ianalumab 的積極 III 期研究結果。昨天,我們發布了主要數據。完整的數據集應該很快就會公佈,我想應該就在明天。
And then our Analyst Day to discuss this data as well as the Rhapsido data as well as other immunology data, including our CAR therapy platform for immunology. Immune reset platform will be on Thursday. So I hope you'll be able to join that, and we'll give you a lot more detail on the secondary endpoints, on post half endpoints, on biopsy data, et cetera.
然後,我們將舉行分析師日,討論這些數據以及 Rhapsido 數據和其他免疫學數據,包括我們的 CAR 免疫學治療平台。免疫重置平台將於週四開放。所以我希望您能參與其中,我們將向您提供更多關於次要終點、中期終點、活檢數據等的詳細資訊。
But here, just on the top line, the Phase III endpoint was met in both studies, statistically significant improvement in ESSDAI. I do want to highlight here, there's a lot of focus, a lot of report on the aggregate ESSDAI from a patient standpoint and a physician standpoint, what matters is where the individual patients are and how much we're able to improve their relative disease.
但就最主要的結果而言,兩項研究均達到了 III 期終點,ESSDAI 有統計學意義上的顯著改善。我想在這裡強調一點,雖然從患者和醫生的角度來看,有很多關於 ESSDAI 綜合評分的關注和報道,但重要的是個別患者的病情以及我們能夠在多大程度上改善他們的相關疾病。
And also what is the starting point for the ESSDAI score. So the fact that we've achieved two positive Phase III trials, I think, will really enable us to roll this out to patients. And then as patients see the symptom benefit given their profile, they'll hopefully be able to get the benefit and stay on the medicine. We have consistent numerical endpoints, improvements in the secondary endpoint, a favorable safety profile. And as I mentioned, the data will be provided shortly.
另外,ESSDAI評分的起始點是什麼?因此,我認為,我們已經取得了兩項積極的 III 期試驗結果,這將真正使我們能夠將這項技術推廣到患者身上。然後,當患者根據自身情況看到症狀改善後,他們有望獲得療效並堅持服用該藥物。我們取得了一致的數值終點,次要終點有所改善,安全性良好。正如我之前提到的,數據很快就會提供。
So regulatory submissions are on track for the first half of '26.
因此,監理申報工作預計將在 2026 年上半年按計畫完成。
And moving to slide 18. Overall, I think a strong innovation year for the company. You can see all the various milestones that we've reached. Also, we've been, I think, the leading player in the sector in terms of deals bringing in medicines at all stages from preclinical to Phase I to late-stage assets, also continuing to bolster our technology platform. So we'll look forward to giving you a full innovation update and technology update at Meet the Management in November.
接下來是第18張投影片。整體而言,我認為對公司而言,這是充滿創新活力的一年。您可以看到我們所取得的所有里程碑。此外,我認為,我們在藥物交易方面一直是該領域的領先者,我們引進了從臨床前到 I 期再到後期階段的各個階段的藥物,同時也在不斷加強我們的技術平台。因此,我們期待在 11 月的管理層見面會上向您全面介紹創新和技術的最新進展。
So with that, let me hand it over to Harry.
那麼,接下來就交給哈利吧。
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Thank you very much, Vas. Good morning, good afternoon, everybody. As usual, I will take you through the financial results now for the third quarter, the first nine months and the full year guidance. And as always, unless otherwise noted, all growth rates are presented in constant currencies. So if we go to our slide 20, you see a summary of the financial performance.
非常感謝你,Vas。各位早安,各位下午好。照例,接下來我將為大家介紹第三季、前九個月的財務表現以及全年業績展望。與以往一樣,除非另有說明,所有成長率均以不變貨幣表示。所以,如果我們翻到第 20 張投影片,您會看到財務表現的摘要。
In the third quarter, net sales grew 7% versus prior year. Core operating income was also up 7%. In the US, we had some negative gross to net true-ups first time since the year. Prior, we had mostly positive. But they were mainly related to Medicare Part D redesign, which was new for the industry this year based on invoices for prior periods, mainly quarter two.
第三季淨銷售額年增7%。核心營業收入也成長了7%。在美國,我們出現了今年以來首次淨利與毛利潤之間的負值調整。此前,我們大多持正面態度。但它們主要與 Medicare Part D 的重新設計有關,這是今年業界的新舉措,主要依據是前期(主要是第二季)的帳單。
And excluding these true-ups, the underlying growth would have been 9% on the top line and 11% on the bottom line as the priority brands and launches continue to offset the increasing generic erosions, mainly for Entresto, Tasigna, and Promacta in the US Our core margin was 39.3% in Q3 and core EPS came in at $2.25, reflecting a 10% increase and free cash flow totaled $6.2 billion.
剔除這些調整後的數據,由於重點品牌和新產品上市繼續抵消仿製藥不斷蠶食市場份額的影響(主要針對美國市場的Entresto、Tasigna和Promacta),公司營收和利潤的實際增長率分別為9%和11%。第三季度,我們的核心利潤率為39.3%,核心每股盈餘為2.25美元,較去年同期成長10%,自由現金流總額為62億美元。
For the first nine months, obviously, as we had less generic erosion, net sales grew 11%, core operating income 18% and the core margin expanded 250 basis points to reach 41.2% and with core EPS at $6.94, up 21%. Free cash flow reached after nine months already $16 billion, growing 26% in US dollars versus prior year.
顯然,在前九個月,由於仿製藥侵蝕較少,淨銷售額增長了 11%,核心營業收入增長了 18%,核心利潤率增長了 250 個基點,達到 41.2%,核心每股收益為 6.94 美元,增長了 21%。九個月後自由現金流達 160 億美元,以美元計價比上年增長 26%。
Moving to next slide. Speaking of free cash flow, up 26% billion, as I mentioned, already close to actually prior year full year $16 billion after nine months. So it really shows continued strong conversion from profits to cash flow.
進入下一張投影片。說到自由現金流,正如我之前提到的,增長了 26 億美元,九個月後已經接近去年全年 160 億美元的水平。這確實表明利潤向現金流的轉換率持續強勁。
And of course, cash flow remains a strategic priority as it increased further our ability to convert strong core operating income growth and robust free cash flow and gives us the capacity to reinvest in our business organically, pursue value-creating bolt-ons like the proposed acquisition of Avidity and return attractive shareholder -- attractive capital levels to our shareholders through growing dividends and share repurchases. Speaking of capital allocation, let's go to the next page, right?
當然,現金流仍然是我們的策略重點,因為它進一步提高了我們實現強勁核心經營收入成長和穩健自由現金流的能力,並使我們能夠對業務進行有機再投資,追求創造價值的附加業務,例如擬議收購 Avidity,並透過不斷增長的股息和股票回購,為股東帶來可觀的資本回報。說到資本配置,我們翻到下一頁吧?
It's really unchanged. And again, based on very strong free cash flow, we really can optimize both a significant investment in the business to drive top and pipeline and returning capital to our shareholders at attractive levels. In the first nine months, aside from Avidity, we have executed multiple bolt-on M&As, smaller in size, but still very important and -- which strengthened our key platforms and pipeline for our four therapeutic areas.
確實沒有任何變化。再次強調,基於非常強勁的自由現金流,我們完全可以優化對業務的重大投資,以推動營收成長和專案儲備,並以具有吸引力的水平向股東返還資本。在前九個月裡,除了 Avidity 之外,我們還完成了多筆規模較小但仍然非常重要的附加併購,這些併購加強了我們在四個治療領域的關鍵平台和產品線。
And of course, we also continue to invest in our internal R&D engine. On the capital return side, we successfully completed our up to $15 billion share buyback program early July and have launched a new up to $10 billion buyback program targeted for completion by the end of 2027.
當然,我們也會繼續加大對內部研發的投入。在資本回報方面,我們在 7 月初成功完成了高達 150 億美元的股票回購計劃,並啟動了一項新的高達 100 億美元的回購計劃,目標是在 2027 年底前完成。
We also have distributed $7.8 billion in dividends during the first half of this year as part of our annual dividend.
今年上半年,我們還派發了78億美元的股息,作為年度股息的一部分。
Turning to the next slide. We reaffirm our full year guidance. We expect high single-digit growth in net sales and low teens growth in core operating income, even after accounting for negative gross to net true-ups in the third quarter. And to complete our outlook, we now anticipate the core net financial expenses is slightly higher at $1.1 billion before we had $1.0 billion, a bit higher hedging costs.
翻到下一張投影片。我們重申全年業績預期。我們預計淨銷售額將實現高個位數成長,核心營業收入將實現兩位數低成長,即使考慮到第三季毛利淨利的負調整。最後,為了完善我們的展望,我們現在預計核心淨財務支出略有上升,為 11 億美元,而我們先前的預期為 10 億美元,對沖成本略有上升。
But overall, nothing dramatic. And the core tax rate continues to be in this range of 16% to 16.5% so far in the first 3 quarters at 16.2%. Now let's move to the next slide. So usually, we don't provide so much level of quarterly guidance, right? Quarters are a bit more volatile than the full year usually.
但總的來說,沒什麼大事發生。前三個季度,核心稅率一直維持在 16% 至 16.5% 的範圍內,目前為 16.2%。現在我們來看下一張投影片。所以通常情況下,我們不會提供如此詳細的季度業績指引,對吧?通常來說,季度波動性比全年波動性更大。
But given that we have US generics entry in the middle of the year for three of our brands, of course, the biggest being Entresto, but also Promacta and Tasigna were, of course, blockbusters, it results in very different quarterly dynamic this and next year. And so as a reminder, in quarter four of last year, we benefited from significant positive gross to net adjustments, which added back then about 3 points of growth.
但考慮到我們旗下三個品牌(當然,其中最大的是 Entresto,而 Promacta 和 Tasigna 當然也是重磅炸彈級產品)的仿製藥將於年中進入美國市場,這將導致今年和明年的季度動態截然不同。因此,提醒大家一下,去年第四季度,我們受益於毛利淨利的大幅正向調整,當時這帶來了約 3 個百分點的成長。
So it makes for a very high prior year base. Adjusting for these one-timers, we expect quarter four underlying growth to be low single digit on the top line and mid-single digit on the bottom line, reflecting the increasing generic erosion from a full year impact of Entresto US
因此,上一年度的基數非常高。在剔除這些一次性因素後,我們預期第四季營收成長將為個位數低段,淨利成長將為個位數中段,這反映出Entresto US全年影響導致仿製藥市場份額不斷下降。
generics but better, obviously, than what we expect to report, including the prior year gross to net adjustments.
雖然是仿製藥,但顯然比我們預期報告的情況要好,包括上一年毛利淨額調整。
We provide full year guidance for 2026, of course, next quarter with the full year results, but you can imagine it will be a year of two halves. The first half of 2026 will be depressed due to the impact of generics with still a high prior year base, but we expect to emerge much stronger in the second half, but much more on that as we go -- as we report our full year results early February.
當然,我們會在下個季度公佈全年業績時提供 2026 年全年業績指引,但您可以想像,這將是分為兩個階段的一年。由於仿製藥的影響,加上去年同期基數較高,2026 年上半年業績將較為低迷,但我們預計下半年業績將大幅回升,更多詳情將在 2 月初公佈全年業績時公佈。
Now let's move to our currency estimate impact of currencies should -- currencies remain where they are basically late October. Then we expect a full year in '25 impact of 0% to 1% on net sales and minus 2% points on core operating. You see also the quarter.
現在讓我們來看看貨幣對匯率的影響估計值——匯率在10月下旬基本上保持不變。那麼我們預計 2025 年全年淨銷售額將受到 0% 至 1% 的影響,核心營運將受到 -2% 的影響。你還能看到那枚硬幣。
And we roll this forward to '26. So in '26, we would expect with these exchange rates, a slight positive 1% point on net sales and basically no material impact on core operating income. And as you know, we publish this on a monthly basis as it is quite difficult to forecast this from the outside in, and we hope you find it helpful. And then lastly, I hope you were able to join our presentation on the proposed acquisition of Avidity yesterday. If not, I would encourage you to listen to the replay.
我們將時間推移到 2026 年。因此,在 2026 年,我們預期以這些匯率,淨銷售額將略微成長 1 個百分點,而對核心營業收入基本上不會產生實質影響。如您所知,我們每月發布一次這份報告,因為從外部預測這種情況相當困難,我們希望它對您有所幫助。最後,我希望您昨天能夠參加我們關於擬議收購 Avidity 的演示。如果還沒聽過,我建議您聽重播。
And -- adding Avidity, as we mentioned yesterday, raises our '24 to '29 sales average growth rate from 5% to 6%. But of course, even more importantly, further supports our mid-single-digit growth over the long term with main impacts, of course, in the 2030s and beyond. And it brings, of course, these near-term product launches two with multibillion blockbuster potential with LOEs in the 2040s and no IRA impact.
而且——正如我們昨天提到的,加上 Avidity,我們的 2024 年至 2029 年平均銷售成長率從 5% 提高到 6%。當然,更重要的是,這將進一步支持我們長期維持個位數中段的成長,其主要影響當然將在 2030 年代及以後顯現。當然,這也帶來了近期推出的兩款產品,這兩款產品具有數十億美元的重磅潛力,預計在 2040 年代實現長期盈利,且不會對 IRA 產生影響。
Now we also mentioned yesterday that we do expect some short-term core margin dilution given Phase III trials are basically now starting to run or up and running shortly in the range of 1% to 2% points for the next 3 years. But we are confident that we return to the 40% margin, which we already achieved this year also will return them back to that in 2029.
我們昨天也提到過,鑑於 III 期試驗基本上已經開始或即將開始,我們預計未來 3 年內核心利潤率將出現 1% 到 2% 的短期稀釋。但我們有信心,我們今年已經恢復到 40% 的利潤率,到 2029 年也將恢復到這個水平。
And please make sure that you also model this 1 points to 2 points core margin dilution as you finalize your 2026 models for us. This deal, of course, overall is expected to deliver very strong sales and profit contributions post -- starting in '29 and then even more and therefore, driving significant shareholder value with a small price to pay over the next three years on the margin dilution as part of the investment. That's all I had for now and handing back to Vas.
另外,請在最終確定 2026 年模型時,請務必將這 1 到 2 個百分點的核心利潤率稀釋也納入模型。當然,總體而言,預計這項交易將在 2029 年開始帶來非常強勁的銷售和利潤貢獻,並且還會更多,因此,將為股東創造巨大的價值,而作為投資的一部分,未來三年利潤率稀釋的代價很小。這就是我現在所擁有的一切,並將其交還給 Vas。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Great. Thank you, Harry. So moving to slide 28. In summary, solid sales and core operating income growth in the quarter despite generic headwinds. So I think we're navigating that well with strong underlying performance of our priority brands, which is reflecting the strong execution, a strong pipeline progress.
偉大的。謝謝你,哈利。接下來是第28張投影片。總而言之,儘管面臨仿製藥帶來的不利影響,本季銷售額和核心營業收入仍實現了穩健成長。所以我認為,憑藉重點品牌強勁的基礎表現,我們很好地應對了這個問題,這反映了我們強大的執行力和強勁的研發進展。
We delivered strong pipeline progress in the quarter. And we also reaffirm our 2025 guidance and remain highly confident in our mid- to long-term growth, which is further bolstered by our proposed acquisition of Avidity, not just through the end of the decade, but into the next decade and beyond.
本季我們在專案儲備方面取得了顯著進展。我們也重申了 2025 年的業績指引,並對我們的中長期成長充滿信心。我們擬議收購 Avidity 將進一步鞏固這一成長,不僅在本十年末,而且在未來十年及以後都將如此。
I want to just quickly remind you as well, we have our immunology pipeline update on October 30, and our Meet Novartis Management on November 19 and 20, in person in London. So thank you again, and we'll open the line for questions.
我也想快速提醒您,我們將於 10 月 30 日發布免疫學管道更新,並於 11 月 19 日和 20 日在倫敦與諾華管理層見面。再次感謝您,我們將開放式熱線回答您的問題。
Operator
Operator
(Operator Instructions)
(操作說明)
Matthew Weston, UBS.
瑞銀集團的馬修‧韋斯頓。
Matthew Weston - Equity Analyst
Matthew Weston - Equity Analyst
Thank you. I hope you can hear me. It's a question about policy, Vas. And we've seen now two companies do deals with the White House around Medicaid and tariffs. And I wondered from your perspective, how much you felt we could see the industry do a cookie cutter of those deals or whether there are meaningfully greater challenges for some companies and when we should expect something from Novartis? And if Harry, I can steal, I guess, an extension of the same question.
謝謝。我希望你能聽到我的聲音。瓦斯,這是一個政策問題。現在我們已經看到兩家公司與白宮就醫療補助和關稅問題達成了協議。我想知道,從你的角度來看,你認為我們會看到整個產業進行千篇一律的交易嗎?或者說,有些公司面臨更大的挑戰?我們該何時才能期待諾華有動作?如果哈利願意,我想我可以藉用同一個問題的延伸部分。
Can you walk us through CapEx over the next five years given the investments that you've announced in the US and how we should think about modeling that as part of cash flow?
鑑於您已宣佈在美國進行的投資,您能否為我們詳細介紹未來五年的資本支出情況,以及我們應該如何將其納入現金流模型?
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Thank you, Matthew. So I think from an industry-wide perspective, I think the pharma industry's view is that the proposed negotiations or proposed actions are not going to address the underlying issues here, which, of course, we believe are PBMs, 340B and importantly, perhaps most importantly, G7 countries and related countries outside the United States properly rewarding innovation and properly assessing the appropriate price for innovation.
謝謝你,馬修。因此,我認為從整個行業的角度來看,製藥業的觀點是,擬議的談判或擬議的行動不會解決這裡的根本問題,當然,我們認為這些問題是藥品福利管理機構 (PBM)、340B 計劃,以及非常重要的,也許最重要的是,七國集團 (G7) 國家和美國以外的相關國家未能適當獎勵創新並適當評估創新的價格。
That said, I think, as you point out, there are I think now three companies that have reached agreements with the administration. I'd say Novartis has -- I can't speak to what other companies are doing. We've been in conversations with the administration since the beginning of the year as we've had the various turns in these discussions.
也就是說,我認為,正如你所指出的,目前已有三家公司與政府達成了協議。我認為諾華公司已經採取了措施——至於其他公司採取了什麼措施,我就不清楚了。自年初以來,我們一直與校方對話,這些討論也經歷了各種轉折。
And I'd say we're meeting with the administration weekly to look at what are the best solutions we can come up with. It is important to note that the President was very clear on the four parameters, and I think those are the four parameters that are in discussion. And we'll have to see in the coming weeks and towards the end of the year if we can come to a proposed approach that makes sense for all involved. And in terms of CapEx, Harry?
我想說,我們每週都會與政府部門開會,探討我們能提出的最佳解決方案。值得注意的是,總統對這四個參數的陳述非常明確,我認為目前討論的也是這四個參數。接下來幾週以及到年底,我們將看看能否提出一個對各方都有利的方案。那麼,就資本支出而言,哈里呢?
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Matthew, I think as we mentioned when we also introduced the $23 billion over the five years commitment, we made it clear that the majority is actually not CapEx. Majority is R&D OpEx, where we have the choice to invest in the US or anywhere else in the world. And we choose, of course, to have a strong commitment also for R&D in the US And then there's a portion, yes, it's CapEx, but it's actually part of our overall worldwide financing plan also for -- and we choose basically incremental to invest in US to build up there our manufacturing base to supply the US from the US instead of further expanding, for example, European sites. So from that standpoint, overall, I don't expect a significant or meaningful CapEx increase.
馬修,我想正如我們在介紹五年內投入 230 億美元的承諾時所提到的那樣,我們已經明確表示,其中大部分實際上並不是資本支出。大部分是研發營運支出,我們可以選擇在美國或世界其他地方進行投資。當然,我們也選擇大力投入美國的研發。其中一部分是資本支出,但實際上也是我們全球整體融資計畫的一部分——我們基本上選擇逐步投資美國,在那裡建立我們的製造基地,從美國向美國供貨,而不是進一步擴張,例如歐洲的工廠。因此從這個角度來看,整體而言,我不預期資本支出會有顯著或實質的成長。
We are always in this range of 2.5% to 3% of sales, actually quite a low end of the industry given our very focused and efficient manufacturing setup.
我們的銷售額始終保持在 2.5% 到 3% 的範圍內,考慮到我們非常專注和高效的生產設置,這實際上在業內屬於相當低的水平。
And it's always -- there can be annual fluctuations, but nothing meaningful. Also, we have further opportunities in cash flow and inventory. They are usually on the high side. We keep that as a bit of a buffer in certain times. So overall, in short, I would not expect a significant CapEx increase.
而且總是如此——可能會有年度波動,但不會有實質的波動。此外,我們在現金流和庫存方面還有其他機會。它們的價格通常都比較高。我們有時會留一些緩衝資金。簡而言之,總的來說,我預計資本支出不會大幅增加。
And I would expect free cash flow to grow roughly in line with core operating income growth.
我預計自由現金流的成長將與核心營業收入的成長大致持平。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Thank you, Matthew.
謝謝你,馬修。
Operator
Operator
Peter Verdult , BNP Paribas.
Peter Verdult,法國巴黎銀行。
Peter Verdult - Analyst
Peter Verdult - Analyst
Pete Verdult, BNP. Only one, so I'll keep it topical for Vas. Just on the market reaction to that ACR abstract, I think you've alluded to it being disappointment and you perhaps sharing a different view. So just pushing you on -- do you think the market depreciation of the data set will improve once we see the full details tomorrow? And just could you remind us, I'm sorry to get technical, of the 12 domains that make up the ESSDAI index, which ones are seen as the most important to patients and physicians? Thank you.
Pete Verdult,BNP。只有一個,所以我會把它當作 Vas 的局部用藥。僅就市場對 ACR 摘要的反應而言,我認為你已經暗示過人們感到失望,而你可能持有不同的觀點。所以,我再追問一下——你認為明天看到全部細節後,市場對該數據集的貶值情況會有所改善嗎?恕我直言,您能否提醒我們一下,在構成 ESSDAI 指數的 12 個領域中,哪些領域被病人和醫生認為是最重要的?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. I mean, I think for us, the most important thing is that we make a compelling proposition to patients and physicians. And then if we deliver a strong launch, then I think, obviously, the markets will do what the markets will do but presumably will follow. I think -- we will present detailed data on Thursday, and I think that will help at least understand where our conviction comes from.
是的。謝謝,彼得。我的意思是,我認為對我們來說,最重要的是我們要向病人和醫生提出一個有說服力的方案。如果我們能夠成功推出一款強勁的產品,那麼我認為,很顯然,市場會按照市場規律行事,但大概也會跟著市場反應。我認為——我們將在周四公佈詳細數據,我認為這至少有助於理解我們的信念從何而來。
I think very important for us is the individual patient benefit. I think practicing physicians and patients don't measure an ESSDAI. They're actually looking for symptomatic benefits in things like fatigue, in salivary flow, in activities of daily living. And I think looking at that -- the global assessment of physicians and how they see patients benefiting is going to be really important for this launch. It's a highly variable disease.
我認為對我們來說,最重要的是病人的個別利益。我認為執業醫生和患者都不會測量 ESSDAI。他們實際上是在尋找諸如疲勞、唾液分泌、日常生活活動等方面的症狀改善。我認為,觀察醫生們的全球評估以及他們如何看待患者受益情況,對於此次產品上市來說至關重要。這是一種病情變化很大的疾病。
So a lot of this will depend on finding those groups of patients that have a significant benefit. And I think important for these patients as well is to feel like they don't need the same level of steroids that they typically are using, which can be hugely disruptive for their lives. Sleep is another topic as well.
因此,很大程度上取決於能否找到那些能從中獲益匪淺的患者群。我認為對這些患者來說,同樣重要的是讓他們感覺自己不需要像往常那樣使用相同劑量的類固醇,因為這可能會嚴重擾亂他們的生活。睡眠也是另一個值得探討的議題。
So we'll present that information. But I think we feel confident that there is a high willingness even from the physicians that we're talking to now in Chicago, a high interest and a high willingness to make this option available for patients.
所以我們會介紹這些資訊。但我認為我們有信心,即使是我們現在在芝加哥接觸的醫生,也表現出很高的意願,他們非常有興趣和非常願意為患者提供這種選擇。
And assuming we can make patients materially feel better versus the current standard of care, which is frankly just high-dose steroids, we expect to be able to drive significant growth from this medicine.
假設我們能夠讓患者在實際治療中感覺比目前的標準療法(坦白說,就是大劑量類固醇)好得多,我們預計這種藥物將帶來顯著的增長。
Operator
Operator
Stephen Scala, TD Cowen.
Stephen Scala,TD Cowen。
Steve Scala - Analyst
Steve Scala - Analyst
Thank you so much. It seems like there may be a subtle change in the messaging on Cosentyx in HS. While Novartis grew overall market share quarter-over-quarter on slide 12 of the Q2 deck, Novartis noted continued HS market growth. And in the Q3 slide deck, that was not stated explicitly. It's clear Novartis has been playing defense on share. But with that now stabilized, is the point that you need to grow the market and it's not growing at the pace that you expected?
太感謝了。看來高階英雄聯盟中 Cosentyx 的訊息傳遞方式可能會發生一些細微的變化。在第二季業績報告的第 12 頁中,諾華公司指出,儘管其整體市佔率較上季成長,但 HS 市場仍持續成長。而在第三季的簡報中,並沒有明確說明這一點。很明顯,諾華在市場佔有率方面一直處於守勢。但現在市場已經穩定下來,關鍵在於你需要擴大市場規模,但市場成長速度卻沒有達到你的預期嗎?
So is that the contour of the market? This would seem to be a factor in whether Novartis grows earnings in 2026. And when Harry was talking about 2026, he didn't say that specifically.
這就是市場的輪廓嗎?這似乎是諾華公司在 2026 年能否獲利成長的因素。而哈里在談到2026年時,並沒有明確提到這一點。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah. Thanks, Steve. So what I can say is that we feel confident that our share has stabilized after the competitor entry. I think we have not seen the market growth that we had originally hoped for that we -- there's clearly a lot of patients who can benefit from biologic therapy with HS. We continue to see this as a $3 billion to $5 billion-plus market, but it's clearly going to take longer for that market to develop.
是的。謝謝,史蒂夫。因此,我可以肯定地說,我們有信心在競爭對手進入市場後,我們的市佔率已經趨於穩定。我認為我們並沒有看到我們最初希望的市場成長——顯然有很多HS患者可以從生物療法中受益。我們仍然認為這是一個規模在 30 億美元到 50 億美元以上的市場,但顯然這個市場的發展還需要更長的時間。
And so I think we probably did not do the careful analysis that you did on our slides, and I'll look to our IR team to do that more carefully in the future. But I think your point is absolutely on that we need to see -- we need to grow this market, and that's what really both companies should really be focused on and get more patients on these therapies. Now with respect to earnings, we don't comment on 2026. We're focused on clearing out 2025. And so once we get there in January, we can provide you our outlook.
所以我覺得我們可能沒有像您一樣對我們的投影片進行仔細分析,我會要求我們的投資人關係團隊在未來更仔細地進行這方面的分析。但我認為你的觀點完全正確,那就是我們需要看到——我們需要發展這個市場,這才是兩家公司真正應該關注的重點,讓更多的病人接受這些療法。至於獲利方面,我們不會對 2026 年的情況發表評論。我們的目標是清空 2025 年的行程。所以,等到一月的時候,我們就可以向你們提供我們的展望了。
I would say that I think I would focus much more on the dynamic growth you saw in the quarter on Kisqali, Pluvicto, Scemblix, Kesimpta, all of which, to my eyes, were ahead of consensus. And I think that's where I think the focus should be now looking ahead for the company. Next question, operator?
我認為,我應該更加關注本季 Kisqali、Pluvicto、Scemblix 和 Kesimpta 的強勁成長,在我看來,這些公司都超出了市場預期。我認為,展望公司未來,這才是我們該關注的重點。接線員,下一個問題是什麼?
Operator
Operator
Shirley Chen, Barclays.
雪莉·陳,巴克萊銀行。
Shirley Chen - Equity Analyst
Shirley Chen - Equity Analyst
Hi, thank you so much for taking my question. Can I ask about Pluvicto. So congrats on a great quarter. Could you please help frame where you are in the launch curve for pre-taxane new label? And how do you expect the inflection in 4Q and also next year? Can you remind us of your peak sales ambition of this drug?
您好,非常感謝您回答我的問題。請問關於Pluvicto有什麼資訊嗎?恭喜你們本季表現出色。請問您能否幫忙描述一下,在新標籤的上市曲線中,您目前處於前紫杉烷類藥物的哪個階段?您預計第四季以及明年的拐點會如何?您能提醒我們一下您對這種藥物的最高銷售目標是什麼嗎?
And when do you expect Pluvicto to reach at the full potential within the PSMAfore population and also potentially PSMAddition population? And also in addition, you -- I think you previously mentioned a few challenges for commercialization, such as reimbursement, education of staffing and referral networks. And how do you find where you are tackling these challenges? Thank you.
您預計 Pluvicto 何時才能在 PSMAfore 群體中以及潛在的 PSMAddition 群體中發揮其全部潛力?此外,我認為您之前提到過商業化方面的一些挑戰,例如報銷、員工培訓和轉診網絡。那麼,你該如何找到應對這些挑戰的切入點呢?謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah. Thanks, Shirley. So for Pluvicto overall, I think we're on the steep part of the curve right now. We see -- as you saw, very strong growth in quarter three. We would expect very solid growth in quarter four.
是的。謝謝你,雪莉。所以就 Pluvicto 整體而言,我認為我們現在正處於曲線陡峭的階段。正如你所看到的,第三季度實現了非常強勁的成長。我們預計第四季將實現非常穩健的成長。
It's important to note in quarter four, we always have a slowdown in the Thanksgiving and Christmas holidays. So in effect, lose two to three weeks because of those holidays, simply because patients don't want to have a nuclear medicine, radioactive medicine that prevents them from being around children or family members, so for a period of time.
值得注意的是,第四季度由於感恩節和聖誕節假期,業務總是會放緩。因此,實際上,由於這些假期,患者會損失兩到三週的時間,只是因為患者不想接受核醫治療,這種放射性藥物會讓他們暫時無法與孩子或家人接觸。
So important to note that. But that said, we do expect continued strong performance in quarter four. And then going into next year, we would expect solid growth, but I think as always with these launches, good growth, but maybe not the same levels of growth you're seeing in quarter three and quarter four, kind of an S-shaped curve. And then our plan would be to bring on the HSPC indication, which will then propel us, we believe, to the $5 billion peak sales that we've guided to.
所以這一點非常重要。但即便如此,我們仍預期第四季業績將持續保持強勁勢頭。展望明年,我們預計會有穩健成長,但我認為,與以往的新品發布一樣,成長良好,但可能不會達到第三季和第四季那樣的成長水平,呈現出一種 S 形曲線。然後,我們的計劃是推出 HSPC 適應症,我們相信這將推動我們實現先前預測的 50 億美元銷售高峰。
So we fully are confident on that. We see high levels of now receptivity. And that, I think, brings me to your point on the structural challenges, which I think we've successfully tackled now with the PSMA and VISION launch, we struggled to get into the community in a way that was scaled. Now through years of effort by our US commercial team, we've successfully, as I noted, have over 700 prescribing clinics across the country.
所以我們對此完全有信心。我們看到現在的接受度很高。我認為,這引出了你關於結構性挑戰的觀點,我認為我們現在已經透過 PSMA 和 VISION 的推出成功解決了這個問題,我們之前一直難以大規模地進入社群。正如我之前提到的,經過我們美國商業團隊多年的努力,我們已經成功地在全國範圍內擁有了 700 多家處方診所。
9 out of 10 patients are very close to a center that can provide Pluvicto. We're adding centers just to be on the safe side. We've done careful mapping to know the referral pathways. Physicians are much more comfortable now using the PFS, a pre-filled syringe and dealing with some of the other logistics associated with radioligand therapy. So we're in a very good spot in that sense.
10 名患者中有 9 名居住在能夠提供 Pluvicto 的中心附近。我們增設中心只是為了以防萬一。我們已經進行了仔細的梳理,以了解轉診途徑。現在醫生們在使用預充式註射器 (PFS) 以及處理與放射性配體治療相關的其他一些後勤問題時,都感覺輕鬆多了。所以從這個意義上講,我們處境非常有利。
And that's what gives us confidence that the pre-taxane launch can propel us into the $3 billion-plus range and then the HSPC launch will propel us into the $5 billion-plus range and will be where we expect. We continue in the as well in the oligometastatic setting as well to go earlier. We also have a number of Phase IV studies, including in the mCRPC setting in combination with ARPIs to give physicians even more options.
正是這一點讓我們有信心,在推出稅前產品後,我們的銷售額將超過 30 億美元,而 HSPC 的推出將使我們的銷售額超過 50 億美元,達到我們預期的目標。在寡轉移性疾病的治療中,我們也繼續努力,爭取更早進行治療。我們還有多項 IV 期研究,包括在 mCRPC 治療中與 ARPI 聯合應用,為醫生提供更多選擇。
So we're doing all of the work as well to fully build out the data package to maximize this medicine. I think while I'm on Pluvicto, I think all of that builds the base for our radioligand therapy platform more broadly.
因此,我們也在努力完善資料包,以最大限度地發揮這種藥物的療效。我認為,在我使用 Pluvicto 期間,所有這些都為我們的放射性配體治療平台奠定了更廣泛的基礎。
We have that full range of 10 -- around 10 different indication medicines that are advancing in the clinic. And now as we bring those forward, we have that infrastructure built in the US and now increasingly Japan, China, and other markets to make those other launches successful. So I think all on the right track. It was a very important element for us to strategically solve.
我們有大約 10 種不同適應症的藥物正在進行臨床試驗。現在,隨著我們推進這些項目,我們在美國建立了基礎設施,現在在日本、中國和其他市場也越來越多地建立了基礎設施,以確保這些項目的成功發布。所以我覺得一切都在朝著正確的方向發展。這是我們需要從策略上解決的一個非常重要的問題。
And in my view, we have solved the challenge of rolling out radioligand therapy in the United States. Next question, operator?
在我看來,我們已經解決了在美國推廣放射性配體療法的難題。接線員,下一個問題是什麼?
Operator
Operator
Florent Cespedes, Bernstein.
弗洛朗·塞斯佩德斯,伯恩斯坦。
Florent Cespedes - Equity Analyst
Florent Cespedes - Equity Analyst
Good afternoon. Thank you very much for taking my question. A question on Rhapsido. Could you maybe share with us how you see the ramp-up of the product as you have a clean safety profile, convenient administration? And do you have any feedback from the Street even though it's still early days? And any thoughts for the situation in Europe, the adoption knowing that the product will be compared with much cheaper drugs? Thank you.
午安.非常感謝您回答我的問題。關於狂想曲的問題。鑑於該產品具有良好的安全性和便捷的使用方法,您能否與我們分享您如何看待該產品的市場推廣?雖然現在還處於早期階段,但你從華爾街得到任何回饋嗎?對於歐洲的情況,您有什麼看法?考慮到該產品將與價格低得多的藥物進行比較,歐洲市場對該產品採用率有何看法?謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah. Thank you, Florent. So we're in the early stages of the launch. Right now, our focus is on sampling through patient start form, getting through patient start forms and negotiating with payers to ensure broad access in the early part of next year. I think once we get to the early part of next year, we get that base up through sampling in this initial phase, we would then start to expect a more rapid uptake through Q2 forward next year, where I think there will be the opportunity then to really drive uptake.
是的。謝謝你,弗洛倫特。所以我們目前還處於發布初期階段。目前,我們的重點是透過患者啟動表格進行抽樣,透過患者啟動表格,並與支付方談判,以確保明年年初能夠廣泛獲得治療。我認為,一旦到了明年年初,透過初始階段的抽樣調查建立起基礎,我們就可以開始期待明年第二季及以後會有更快的普及速度,屆時我認為將有機會真正推動普及。
We would expect initial uptake to be in patients who are not responding to biologic. But then our goal very much is to be positioned pre-biologic. That's really where the opportunity is for this medicine, and that's what we're going to be our long-term focus in the US and really around the world. I think in Europe, you raised an important point.
我們預計最初的接受者將是那些對生物製劑沒有反應的患者。但我們的目標很大程度上是佔據生物製劑之前的市場地位。這才是這種藥物的真正機會所在,也是我們未來在美國乃至全世界的長期發展重點。我認為在歐洲,你提出了一個重要的觀點。
I mean, a lot of this will come down to our payer negotiation. And I think in light of the current situation in the US, it will be absolutely our goal to hold the line and ensure that Rhapsido is appropriately reimbursed for the innovation it's bringing and not have it be compared to old generic drugs, but really compared to what it is a pureless oral twice-a-day option for patients that really need a rapid onset of action.
我的意思是,很多事情最終都將取決於我們與付款方的談判。我認為,鑑於美國目前的形勢,我們的目標絕對是堅守底線,確保 Rhapsido 因其創新而獲得適當的報銷,而不是與舊的仿製藥進行比較,而是真正將其與一種純粹的、每天兩次的口服藥物進行比較,這種藥物適用於真正需要快速起效的患者。
And we're hopeful that European payers will realize that and then appropriately reward it, and then we'll be willing to be patient to achieve that. But then I think once we get access, all of our indications, there's a lot of enthusiasm in both the allergists and the derm community for a safe oral option, and we should see rapid uptake there as well. So I think overall, very excited about the medicine.
我們希望歐洲的支付方能夠意識到這一點,並給予適當的獎勵,而我們也願意耐心等待這一目標的實現。但我認為,一旦我們獲得所有適應症,過敏科醫生和皮膚科醫生都對安全的口服藥物表現出極大的熱情,我們應該也會看到這種藥物迅速被接受。所以總的來說,我對這種藥感到非常興奮。
As you know, we're progressing as well in CINDU. We would expect that readout next year. We're progressing in food allergy. We're progressing in HS. So we have a number of opportunities now ahead of us as well for this medicine.
如您所知,我們在CINDU專案上也取得了進展。我們預計明年會公佈相關數據。我們在食物過敏領域取得了進展。我們在高中階段取得了進步。所以,這種藥物現在也為我們帶來了許多機會。
Next question.
下一個問題。
Operator
Operator
James Quigley, Goldman Sachs.
James Quigley,高盛集團。
James Quigley - Analyst
James Quigley - Analyst
Hello, thank you for taking my question. I've got a follow-up on Ianalumab, please. So one question we've had is that, obviously, the slide suggests in NEPTUNUS-1 that statistical significance was only achieved in the last two blocks of data. Was that just because of when the tests were run? Or is that sort of what you're expecting as well in terms of when you're planning the study? And a second quick one on Ianalumab as well, hopefully not to pre-empt tomorrow or Thursday.
您好,感謝您回答我的問題。我還有一個關於Ianalumab的後續問題,請問如何解決?所以我們遇到的一個問題是,很明顯,幻燈片顯示,在 NEPTUNUS-1 中,只有在最後兩組數據中才達到了統計顯著性。那隻是因為測試進行的時間嗎?或者,當您在規劃這項研究時,也是這麼預期的嗎?還有一則關於 Ianalumab 的簡短訊息,希望不會影響到明天或週四的討論。
But you talk about the sort of secondary endpoints and fatigue and salivary flow being more important, but the secondary endpoints were not statistically significant. So again, was this a case of hierarchical testing or anything else? How can you show that when you -- when the drug hopefully gets approved and you talk to physicians about the data? Thank you.
但你提到次要終點、疲勞和唾液流量等指標更為重要,但這些次要終點指標在統計學上並不顯著。所以,這究竟是分層測試還是其他情況?當藥物有望獲得批准,並且你與醫生討論數據時,你如何證明這一點?謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah, absolutely. I mean, I think the endpoint here is at 52 weeks. And so I think we were trying to indicate all of the time points to reach nominal significance. But given that endpoint, the goal here is 52 weeks, and both studies achieved the prespecified primary endpoint at 52 weeks in the independent analysis and in the pooled analysis. So no issues there.
是的,絕對是如此。我的意思是,我認為終點是 52 週。所以我覺得我們當時是想指出所有達到名目顯著的時間點。但鑑於該終點,這裡的目標是 52 週,兩項研究在獨立分析和匯總分析中均達到了預先設定的主要終點(52 週)。所以這方面沒有問題。
And so we feel from a regulatory standpoint, we've -- 48 weeks, excuse me, 48 weeks the standard. So I think you can see here on slide 17, 48 weeks was hit in both trials. And then -- separate from that, there is hierarchical testing here as often is the case. And so if one of the secondaries are hit, even if they hit from a nominal standpoint and lower the hierarchy, it's no longer valid from a pure statistical hierarchy standpoint. It could be nominally statistically significant but wouldn't reach the threshold from a regulatory standpoint.
因此,從監管的角度來看,我們認為——48 週,抱歉,48 週是標準。所以我想你可以從第 17 張投影片看到,兩次試驗都達到了 48 週。此外,這裡還有分層測試,這種情況很常見。因此,如果其中一個次要目標被擊中,即使從名義上看,它降低了層級,但從純粹的統計層級角度來看,它就不再有效了。雖然從統計學角度來看可能具有顯著性,但從監管角度來看,它達不到閾值。
That said, I mean, I think as I've tried to articulate, there's the regulatory standpoint here. And in a disease that's never had an approved drug, there's really what our patients and physicians looking for. And we've really tried to understand once we hopefully can get the regulatory approval, then what do we need to educate physicians and patients on.
也就是說,我的意思是,正如我試圖闡述的那樣,這裡存在著監管方面的問題。對於一種從未有過核准藥物的疾病來說,這正是我們的病人和醫生真正想要的。我們一直在努力了解,一旦我們被期望獲得監管部門的批准,我們需要對醫生和患者進行哪些方面的教育。
So you'll hear more about that on Thursday, but our team has done a range of analyses to look at secondary outcomes, look at post-hoc outcomes, look at also biopsies and really try to demonstrate that you're seeing the benefits that patients want. I myself have spent time talking to patients with Sjögren's.
所以,週四你們會聽到更多相關信息,但我們的團隊已經進行了一系列分析,以研究次要結果、事後結果、活檢結果,並真正努力證明你看到了患者想要的益處。我自己也曾花時間與患有乾燥症的患者交談。
And I think what really matters to them is quality of life metrics and very specific quality of life metrics that varies patient to patient. So I don't think that for them that the ESSDAI score is going to make the difference. It's going to be whether or not their symptoms are getting better and they can live their daily life day in and day out better. Next question.
我認為對他們來說真正重要的是生活品質指標,以及因人而異的具體生活品質指標。所以我認為對他們來說,ESSDAI 分數不會起到決定性作用。關鍵在於他們的症狀是否有所好轉,以及他們能否更好地過上日常生活。下一個問題。
Operator
Operator
(Operator Instructions)
(操作說明)
Richard Vosser, JP Morgan.
Richard Vosser,摩根大通。
Richard Vosser - Analyst
Richard Vosser - Analyst
Hi, thanks for taking my question. One on Kesimpta, please. Just whether you're seeing any impact in the US from the OCREVUS subcutaneous launch. It doesn't seem like it but just wondering what you're seeing here. And linked to that, there's some discussion from you about your new formulation.
你好,謝謝你回答我的問題。請給我一輛凱西姆普塔街的。只是想知道 OCREVUS 皮下注射劑在美國上市後是否產生了任何影響。雖然看起來不像,但我只是好奇你在這裡看到了什麼。與此相關的是,您也討論了您的新配方。
Just wondering on details of treatment interval, whether this could be a new BLA and how this could protect from potential biosimilars down the line. Thanks very much.
我只是想了解治療間隔的細節,這是否可能是一項新的生物製品許可申請(BLA),以及這如何能防止未來出現潛在的生物相似藥。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. So on OCREVUS subcu, we don't see an impact to date, as you can see on our overall performance. We're holding share in a growing market. I think -- the overall market growth for multiple sclerosis drugs has been solid.
是的。謝謝你,理查。因此,就 OCREVUS 子包膜而言,到目前為止我們還沒有看到任何影響,正如您在我們的整體表現中所看到的那樣。我們在不斷成長的市場中佔有了一席之地。我認為-多發性硬化症藥物的整體市場成長一直很穩健。
Within that, the B-cell class continues to steadily increase with a bigger opportunity outside of the US, but still we see the opportunity. I think 25% of patients in the US, give or take, are still not on B-cell therapies that could be. And so we're really benefiting from the market growth.
其中,B 細胞類別持續穩定成長,在美國以外地區擁有更大的發展機遇,但我們仍然看到了機會。我認為美國大約有 25% 的患者還沒有接受 B 細胞療法,而他們本來可以接受這種療法。因此,我們確實從市場成長中受益匪淺。
We are doing a lot of work now to get better at targeting physicians that we think would be more amenable to a patient self-administered administration rather than the various other options available. But I think overall, this is a growing market where the medicine is holding its share, performing really well.
我們現在正在做很多工作,以便更好地鎖定我們認為更願意接受患者自行給藥而不是其他各種給藥方式的醫生。但我認為總體而言,這是一個不斷成長的市場,這種藥物佔據了一定的份額,表現非常出色。
It's all volume-driven growth. From a life cycle management standpoint, we are advancing our Q2-month formulation. And so we'll keep you updated as we progress, but that's something that's a trial that's currently on rolling.
完全是銷量驅動型成長。從生命週期管理的角度來看,我們正在推進第二季度的配方制定。因此,我們會隨時向您報告進展情況,但這目前仍是一項正在進行中的試驗。
And then we're exploring other options, no details I can get into at this point to get into longer intervals as well potentially with novel technologies. And I think as those progress and if there is the opportunity to get those launched before biosimilar entry, that's something that we're highly, highly focused on, absolutely.
然後,我們正在探索其他方案,目前還不能透露細節,例如採用新技術來延長間隔時間。我認為,隨著這些藥物的研發進展,如果有機會在生物相似藥上市之前推出這些藥物,那絕對是我們高度重視的事情。
But I think it's premature to comment on that at this point.
但我認為現在對此發表評論還為時過早。
Next question, operator?
接線員,下一個問題是什麼?
Operator
Operator
Thibault Boutherin, Morgan Stanley.
Thibault Boutherin,摩根士丹利。
Thibault Boutherin - Analyst
Thibault Boutherin - Analyst
Yeah, thank you. Just a question on abelacimab, the injectable Factor XI acquired with Anthos. I think we're getting the first Phase III data in AFib next year. This is for patients at high risk of bleeding and for whom oral anticoagulants is not adequate. Can you just sort of frame the opportunity in terms of size? And are you looking to potentially go into a broader patient population with this asset?
是的,謝謝。關於阿貝拉西單抗(abelacimab,一種注射用因子XI抑制劑,由Anthos公司收購)我有個問題。我認為我們明年就能獲得心房顫動治療的首批 III 期臨床試驗數據。這適用於出血風險高且口服抗凝血劑不足以治療的患者。你能從規模的角度來描述這個機會嗎?您是否考慮將這項技術應用於更廣泛的患者群體?
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah. Thanks, Thibault. So this is the -- as you know, the antibody that we acquired back from Anthos is originally a Novartis-originated antibody. So we know it quite well. As you know, the study next year will be in patients who are ineligible for DOACs, NOACs.
是的。謝謝你,蒂博。所以,如您所知,我們從 Anthos 公司獲得的抗體最初是諾華公司研發的抗體。所以我們對它非常了解。如您所知,明年的研究對象將是不適合使用 DOAC 和 NOAC 的患者。
And so the opportunity here is for these patients, which is a reasonable sizable patient population to provide them a significant option with monthly dosing. I think the opportunity here will really -- the size of the opportunity, we believe is multibillion, but the scale of that multibillion-dollar opportunity will really depend on how the oral Phase III program from one of our competitors performs.
因此,對於這些患者(這是一個相當龐大的患者群體)來說,這是一個機會,可以為他們提供一個每月給藥的重要選擇。我認為這裡的機會確實——我們認為機會的規模是數十億美元,但這個數十億美元機會的規模實際上將取決於我們競爭對手之一的口服 III 期項目的表現。
I mean, clearly, if that oral medicine, which is an all comers in a very large study, if that is unsuccessful, then we would have a very significant potential with our medicine. I think with an oral and an antibody, we'll be much more than focused on these more refractory patients and the opportunity won't be quite as large. But I think in either case, it will be a multibillion-dollar asset we can bring into our cardiovascular portfolio.
我的意思是,很顯然,如果這種口服藥物(一項非常大規模的研究中的所有受試者都參與了這項研究)不成功,那麼我們的藥物將具有非常大的潛在優勢。我認為,有了口服藥物和抗體,我們將更專注於這些難治性患者,機會就不會那麼大了。但我認為無論如何,這都將是我們能夠納入心血管投資組合的價值數十億美元的資產。
And we're -- yes, we're quite excited about it. Next question, operator?
是的,我們對此感到非常興奮。接線員,下一個問題是什麼?
Operator
Operator
Michael Leuchten, Jefferies.
Michael Leuchten,傑富瑞集團。
Michael Leuchten - Analyst
Michael Leuchten - Analyst
Thank you very much. If I could please go back to Cosentyx. Could you tell us, please, what your pricing assumptions, the net pricing assumptions are for the US into the fourth quarter? Do you expect any drag? And just trying to understand the increase in step-up dosing comment on your slides around HS, the 25% utilization.
非常感謝。如果可以的話,我真想回到Cosentyx。請問貴公司對美國市場第四季的定價假設,即淨定價假設是什麼?你預計會有阻力嗎?我只是想了解您在幻燈片中關於 HS 的評論中提到的階梯式劑量增加的情況,以及 25% 的利用率。
Could you put that into context? What was that maybe at the half of the year? And how has that developed? Thank you.
能解釋一下這句話的背景嗎?那大概是年中的時候吧?那麼,它又是如何發展的呢?謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah. Thanks, Michael. So on Cosentyx pricing, we don't expect any shifts going into quarter four. And I'd say, overall, we expect stable gross to nets as well going into next year. I mean it's relatively mature brand, but also with multiple new indications and a solid payer position.
是的。謝謝你,麥可。因此,關於 Cosentyx 的定價,我們預計第四季度不會有任何變化。而且我認為,整體而言,我們預計明年毛利潤與淨利比率也將保持穩定。我的意思是,這是一個相對成熟的品牌,但同時也擁有多個新的適應症和穩固的支付方地位。
So I think we should be stable on that front. We are also monitoring the impact of the Part D redesign, but most of the impacts we've seen on Part D redesign have actually been on Entresto earlier in the year, and then I think that will fade away now as generics enter.
所以我認為我們在這方面應該會比較穩定。我們也在關注D部分重新設計的影響,但我們目前看到的D部分重新設計的影響主要集中在今年早些時候的Entresto上,我認為隨著仿製藥的進入,這種影響將會逐漸消失。
On HS, this really referred to the fact that early on with the competitor launch, what we were seeing is with patients who were on the monthly dosing, if they weren't seeing the effect that they are, physicians weren't seeing the effect that they hoped for, the effect was wearing off, they were switching rather than up dosing Cosentyx every two weeks.
在 HS 上,這實際上是指,在競爭對手產品上市初期,我們看到的是,那些每月服用一次藥物的患者,如果他們沒有看到預期的效果,醫生也沒有看到他們希望的效果,效果正在減弱,他們就會換藥,而不是每兩週增加一次 Cosentyx 的劑量。
And so now we see about 25% of patients on Cosentyx moving up to that every other week dosing. And that's something we'd like to get even higher over time because I think that really demonstrates patients are persisting on Cosentyx, and that's going to be important for us to retain our greater than 50% NBRx share and then the correlating TRx share as well.
因此,現在我們看到大約 25% 的 Cosentyx 患者開始改為每兩週給藥一次。我們希望隨著時間的推移,這個數字能夠更高,因為我認為這真正表明患者正在堅持使用 Cosentyx,這對我們保持 50% 以上的 NBRx 份額以及相應的 TRx 份額都非常重要。
So that's very much in focus for us. And then I'd come back again that we also just need to work on growing the market. I think if this ends up being two competitors just trading the same group of patients, that would be disservice to this patient community. I think we have to get better now at reaching patients who have either fallen out of the system or for whatever reason are being identified as biologic appropriate patients and get them on therapy. Next question, operator?
所以這是我們非常關注的重點。然後我又會回到正題,說我們還需要努力拓展市場。我認為,如果最終變成兩個競爭對手爭奪同一批患者,對患者群體來說就是一種傷害。我認為我們現在必須更好地聯繫到那些已經脫離醫療體系的患者,或者由於各種原因被認定為適合接受生物學治療的患者,並讓他們接受治療。接線員,下一個問題是什麼?
Operator
Operator
Simon Baker, Rothschild & Company, Redburn.
西蒙貝克,羅斯柴爾德公司,雷德伯恩。
Simon Baker - Analyst
Simon Baker - Analyst
I hope you can hear me okay. So this is Qize Ding speaking on behalf of Simon Baker. So I have one quick question. So one quick question on the rebate adjustment. Is there anything you can call out other than the Cosentyx? And also, did any drug benefit from the rebate adjustment in the Q3? Thank you.
希望你能聽清楚我說話。我是丁啟澤,代表西蒙貝克發言。我還有一個問題。那麼,關於退款調整,我還有一個問題。除了Cosentyx之外,還有什麼值得一提的嗎?另外,第三季是否有任何藥物受益於回扣調整?謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah. Thank you for the question. I'll hand that to Harry.
是的。謝謝你的提問。我把這個交給哈利。
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Yeah. Thank you for the question. So overall, of course, when you see the amount that is prior period is roughly $180 million. You see that this has about this 1.5 almost rounding the 7% to 9%, if you will, effect on the quarter. And Cosentyx is a big piece of it.
是的。謝謝你的提問。所以總的來說,當然,你會看到前期金額大約是 1.8 億美元。您可以看到,這對本季產生約 1.5 倍的影響,將 7% 提高到 9%。而Cosentyx是其中的重要組成部分。
Another big piece of it is Entresto actually where patients got quicker into the catastrophic as part of the Medicare Part D redesign. And of course, that part really should go away as Entresto kind of goes away. And there has been some smaller elements, including like really going back into '24 with some inflation penalty part. But the two biggest ones are Cosentyx and Entresto.
另一個重要方面是 Entresto,實際上,作為 Medicare Part D 改革的一部分,患者更快地陷入了災難性境地。當然,隨著 Entresto 逐漸消失,那部分也應該隨之消失。還有一些較小的因素,例如,實際上要回到 2024 年,並加入一些通膨懲罰條款。但其中最大的兩個品牌是 Cosentyx 和 Entresto。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Thank you, Harry.
謝謝你,哈利。
So Sharon, next question.
莎倫,下一個問題。
Operator
Operator
(Operator Instructions)
(操作說明)
Rajesh Kumar, HSBC.
Rajesh Kumar,匯豐銀行。
Rajesh Kumar - Analyst
Rajesh Kumar - Analyst
Hi, good afternoon. Just trying to understand the margin cadence over 2026. I know you're not giving a '26 guidance at the moment. But very helpfully, you said it will be a year of two halves. So given what you know about Part D now and how generics are coming and what sort of operational gearing you're getting on your Kesimpta, Pluvicto, and other, drugs which are growing. If you were not cutting the costs, would the cadence be a lot more steeper?
嗨,下午好。只是想了解2026年之前的利潤率走勢。我知道你目前沒有給 2026 年的指導。但你很有幫助地指出,今年將分成兩個階段。所以,鑑於你現在對D部分(處方藥)的了解,以及仿製藥的發展趨勢,還有你在Kesimpta、Pluvicto和其他正在增長的藥物方面所獲得的運營支持。如果不削減成本,生產節奏會不會更陡峭?
And what have your actions done to offset that impact? So what is the mix impact versus self-help? If you could help us quantify as well as the seasonality of Part D cadence? Because this year, you have done a prior period adjustment that might not be the next year because you have some accrual history now. So you will base your quarterly accruals on the evidence you have.
你們採取了哪些行動來抵銷這種影響?那麼,混合式介入與自助介入相比有何影響?如果您能幫助我們量化D部分節奏的季節性變化,那就太好了?因為今年您進行了前期調整,而明年可能就不會進行調整了,因為您現在有一些應計歷史數據。因此,您將根據所掌握的證據來確定季度應計項目。
So it would really help us model out first half, second half for '26.
這樣就能真正幫助我們模擬 2026 年上半年和下半年的情況。
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Yeah. Thank you, Rajesh. A very thoughtful question, of course. And so in our business with our mix, we usually do not have Medicare kind of related different gross to net levels quarter-by-quarter other than when we have a gross to net true-up, right? So when channel mix changes, when a product goes quickly into the catastrophic and those -- if there are -- I mean, there are always some deviations, right?
是的。謝謝你,拉傑什。這當然是一個非常值得深思的問題。因此,在我們的業務組合中,除了進行毛利淨額調整之外,我們通常不會像醫療保險那樣,每個季度都有不同的毛利淨額水準。所以當通路組合發生變化,當一個產品迅速走向災難性失敗時——如果真的發生了——我的意思是,總是會有一些偏差,對吧?
We have over 20 billion RDs in US But when these are significant or meaningful, then we let you know, right, how much it is, like in quarter four of last year, it was 3 points of growth, which is now impacting as a high base. quarter one was 2 points to the positive and quarter three is now 2 points to the negative. So we show you that stuff. But that's basically true-ups.
美國有超過200億的研發人員。但當這些成長顯著或有意義時,我們會告知您具體數字,例如去年第四季成長了3個百分點,但由於基數較高,現在的影響已經顯現。第一季成長了2個百分點,而第三季則下降了2個百分點。所以我們會把這些內容展示給你。但這基本上只是調整而已。
The underlying is not changing quarterly dynamics for us. So for next year, you will have a very high base Q1 right, with the 2 points of growth that we got from the -- and you will have a relatively low base in Q3 from the 2 negative points this year. And other than that, it's all about launch uptake and generic erosion of the three main products. Maybe long-winded, but I hope it was addressing your question.
對我們來說,基本面並沒有發生變化,季度動態也未改變。所以明年第一季的基數會非常高,因為我們從…中獲得了 2 個百分點的成長——而第三季的基數會相對較低,因為今年出現了 2 個百分點的負成長。除此之外,一切都取決於三大主要產品的上市推廣和仿製藥的侵蝕情況。可能有點囉嗦,但我希望我的回答能解答你的問題。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
And we'll do our best, I think, at the full year earnings as well to provide more guidance on how best to think about the full year 2026.
我認為,我們也會盡力做好全年獲利預測,以便為如何最好地考慮 2026 年全年提供更多指導。
Next question, Sharon.
下一個問題,莎倫。
Rajesh Kumar - Analyst
Rajesh Kumar - Analyst
Thank you.
謝謝。
Operator
Operator
Matthew Weston, UBS.
瑞銀集團的馬修‧韋斯頓。
Matthew Weston - Equity Analyst
Matthew Weston - Equity Analyst
Thank you. It's just a quick follow-up actually to one of the prior questions. Harry, Kesimpta looks like a very strong quarter in Q3 that looks somewhat off trend. And I'm just making sure that as we go into Q4, we aren't going to learn that it was lumpy one way versus the other. Can you just confirm that was underlying operational growth?
謝謝。實際上,這只是對之前某個問題的快速補充。Harry,Kesimpta 第三季看起來非常強勁,但似乎有點偏離趨勢。我只是想確保進入第四季度時,我們不會發現業績表現得過於不穩定。能否確認一下這確實是營運層面的成長?
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Absolutely. Harry?
絕對地。哈利?
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Yeah, it was mainly underlying operational growth, a little bit of inventory, but not much.
是的,主要是基本面的營運成長,庫存也有一點增加,但不多。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Just a strong global volume, I think, in both US and ex US for this matter. Next question.
我認為,就此事而言,無論是在美國還是在美國以外,全球交易量都十分強勁。下一個問題。
Matthew Weston - Equity Analyst
Matthew Weston - Equity Analyst
Perfect, thank you.
太好了,謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Next, question.
接下來,提問。
Operator
Operator
Simon Baker, Rothschild & Company, Redburn.
西蒙貝克,羅斯柴爾德公司,雷德伯恩。
Simon Baker - Analyst
Simon Baker - Analyst
Just one quick question on the Ianalumab in Sjogrenâs disease. So we observed the placebo response in the Sjogrenâs trial tend to be plateau at week 48. So why did it reverse in the first trial of those two Phase III trials, please? The Phase III trial is called NEPTUNUS 1. Thank you.
關於 Ianalumab 在乾燥症的應用,我有一個簡短的問題。因此,我們觀察到,在乾燥症的試驗中,安慰劑效應往往在第 48 週達到平台期。那麼,為什麼在兩項三期臨床試驗中的第一次試驗中結果發生了逆轉呢?第三階段試驗名為 NEPTUNUS 1。謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah. I think the question is regarding the placebo response. I mean I think -- look, I think these were both adequately controlled, well-designed studies, global studies. This is just a highly variable disease. And so you're going to see some variability in how the placebo responds.
是的。我認為這個問題是關於安慰劑效應的。我的意思是,我認為——你看,我認為這兩項研究都是控制得當、設計良好的全球性研究。這是一種病情變化很大的疾病。因此,你會看到安慰劑的反應有些差異。
When we look at background therapy as well, it's very comparable across the studies and so also versus normal standard of care. You do see as well that the month data looks much better than the Q3-month data, but you do see as well the dose response that we would expect.
當我們檢視背景治療時,會發現各項研究的結果都非常相似,與常規標準治療相比也是如此。您還可以看到,本月的數據比第三季的數據好得多,但您也可以看到我們預期的劑量反應。
So I think that's all positive. And so we'll have our experts on the line on Thursday. So if you want to get into more detail, and they'll also be able to go through some of the background on the study design and baseline characteristics.
所以我覺得這都是好事。因此,我們的專家將於週四在線解答問題。所以,如果您想了解更多細節,他們也可以介紹一些關於研究設計和基線特徵的背景資訊。
But I think, obviously, I can't comment more until the full data is presented.
但顯然,在全部數據公佈之前,我無法發表更多評論。
Next question, Sharon?
下一個問題,莎倫?
Operator
Operator
Stephen Scala, TD Cowen.
Stephen Scala,TD Cowen。
Steve Scala - Analyst
Steve Scala - Analyst
Well, thank you for the follow-up. Novartis raised the long-term revenue guidance yesterday, half of which was attributed to the existing business. Of the half attributed to the existing business, how much is due to currently marketed products? And how much is due to higher sites for the pipeline agents? Thank you.
謝謝你的後續跟進。諾華公司昨天上調了長期營收預期,其中一半歸功於現有業務。在歸因於現有業務的一半中,有多少是由於目前已上市的產品造成的?管道代理商的站點位置越高,這其中有多少是由於站點位置較高所造成的?謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah, Steve, I think we can provide better midterm guidance on that and meet the management. But most of that is in-line brands. Obviously, you see the strong performance of Kisqali, Kesimpta, Pluvicto, Scemblix, I think solid performance on Leqvio. And there is probably some in there of what we expect will be a strong launch for remibrutinib, so Rhapsido and the label expansion for Pluvicto. Yes, I think that's roughly the breakdown more or less.
是的,史蒂夫,我認為我們可以就此提供更好的中期指導,並與管理層會面。但其中大部分是常規品牌。顯然,Kisqali、Kesimpta、Pluvicto、Scemblix 的表現都很出色,我認為 Leqvio 的表現也很穩健。其中可能包含一些我們預期的瑞布替尼的強勁上市計劃,以及瑞普西多和普魯維託的標籤擴展。是的,我想大致情況就是這樣。
I think any other pipeline assets we would expect to have limited ramp in this period, just given how long it takes to ramp up these launches when you think out to '29. And we will provide guidance as well out to 2030, as I said yesterday, and meet the management as well as update our peak sales guidance on our various brands where appropriate.
我認為,考慮到 2029 年這些項目的啟動需要很長時間,我們預計其他任何管道資產在此期間的產能提升都將受到限制。正如我昨天所說,我們還將提供 2030 年的指導,並與管理層會面,並在適當的時候更新我們各個品牌的銷售高峰預期。
Next question, Sharon?
下一個問題,莎倫?
Operator
Operator
James Quigley, Goldman Sachs.
James Quigley,高盛集團。
James Quigley - Analyst
James Quigley - Analyst
Thank you. Just a quick one for me. I mean you may have already answered it, Harry, but again, it's coming back to the Cosentyx, the rebate adjustment. Which prior periods does that relate to? Is that a Q1, Q2 this year? Or is that a 2024 thing?
謝謝。我只需要簡單回答一下。我的意思是,哈里,你可能已經回答過了,但再說一遍,這又回到了 Cosentyx 的退款調整問題上。這指的是哪些前期?那是今年的第一季還是第二季?還是說那是2024年的事?
I'm just trying to think in terms of modeling for next year as we look at Cosentyx. Is there a slight headwind from where there was a higher price that you realized in Q1 and Q2 that then reversed out in Q3? And also what does that mean sort of going forward into 2026? Again, I appreciate there is going to be other dynamics with PMR and HS, but just wanted to clarify that from a modeling perspective. Thank you.
我正在思考明年Cosentyx的建模策略。第一季和第二季價格較高,但第三季價格回落,這是否造成了一些不利影響?那麼,展望2026年,這又意味著什麼呢?我再次強調,PMR 和 HS 之間還會存在其他動態關係,但我只是想從建模的角度澄清一下。謝謝。
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Thank you, James. It's mainly quarter two this year, most of it. And -- but the quarter three underlying, that's why we gave you the quarter three underlying is what the underlying is already taking into account if such channel mix would continue to prevail. So from that standpoint, it gives you a good basis for future modeling.
謝謝你,詹姆斯。主要是今年第二季的情況。但是——這就是我們向您提供的第三季基礎數據的原因,第三季基礎數據是指,如果這種通路組合繼續盛行,基礎數據已經考慮在內。因此從這個角度來看,它為未來的建模奠定了良好的基礎。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
I think, Harry, if I'm correct, if you net out the prior period upside versus this that really the year-to-date is relatively clean.
我認為,哈利,如果我是對的,如果你扣除前期上漲的部分,那麼今年迄今為止的業績確實相對乾淨。
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Across the whole portfolio.
涵蓋整個投資組合。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Across the whole company, the year-to-date is close to red.
從整個公司來看,今年迄今的業績接近虧損。
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
quarter one, we had 2% upside. Now we have almost 2% downside, right? It's a bit different brand by brand. But that's why we've given you on the brand that has most of it and is -- Entresto is deteriorating, of course, but this one, of course, is a brand that will stay long with us. That's why we gave you the underlying, which gives you the real underlying at the moment for quarter three.
第一季度,我們有 2% 的上漲空間。現在我們有近2%的下跌空間,對吧?不同品牌的情況略有不同。但正因如此,我們才向您推薦了擁有最多市場份額的品牌——當然,Entresto 正在走下坡路,但這個品牌當然會長期陪伴我們。這就是為什麼我們向你提供了基礎數據,讓你了解第三季目前的真實基礎狀況。
James Quigley - Analyst
James Quigley - Analyst
Got it, thank you.
明白了,謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Next question.
下一個問題。
Operator
Operator
Sachin Jain, Bank of America.
Sachin Jain,美國銀行。
Sachin Jain - Analyst
Sachin Jain - Analyst
Hi, thanks for my questions. So firstly, just a clarification on margins for Harry. So 3Q margins were a little bit below Street. I guess, partly on gross margin, which is sort of first impact from generics. I wonder if you could just talk about gross margin, EBIT margin as we think about a full year of Entresto impact in '26. My simple question is, can you maintain margins stable next year through the full year of generics before we model the underlying Avidity dilution?
您好,感謝您提出的問題。首先,我想向哈利澄清一下關於頁邊距的問題。所以第三季利潤率略低於華爾街預期。我想,部分原因是毛利率,這算是仿製藥帶來的首要影響。我想知道,在我們考慮 Entresto 在 2026 年全年的影響時,您能否談談毛利率和息稅前利潤率?我的問題很簡單,在模擬 Avidity 潛在稀釋之前,您能否在明年仿製藥全面上市期間保持利潤率穩定?
And then given, I might just take an additional one on pipeline for Vas. You flagged good uptake in IgAN. You have the Phase III for the APRIL, BAFF next year. So I wonder if you could just talk to your excitement on that and differentiation and what's the competitive landscape? Thank you.
然後,考慮到這一點,我可能會再接一個關於 Vas 管道的專案。您指出IgAN的吸收情況良好。你們有明年四月的BAFF第三階段比賽。所以我想知道您能否談談您對這一點的興奮之情、產品差異化以及競爭格局?謝謝。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Great. Harry?
偉大的。哈利?
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
Harry Kirsch - Chief Financial Officer, Member of the Executive Committee
So on the margins, of course, when you have a product like a small molecule, high-priced products like the 3 going off patent, especially Entresto being so big, there's a slight negative mix effect. Now Kisqali is also a super high-margin product, right, and growing significantly.
所以,當然,從邊緣來看,當像 3 這樣的小分子高價產品專利到期時,尤其是像 Entresto 這樣規模龐大的產品,會產生輕微的負面混合效應。現在 Kisqali 也是一款利潤率極高的產品,對吧,而且成長勢頭強勁。
So that's partly offsetting. But we have also a significant productivity efforts, especially in our manufacturing and supply chain. So as I mentioned before, there will be, as we go forward, some pressures on the gross margin.
所以這在一定程度上抵消了影響。但我們也大力提高生產力,尤其是在製造業和供應鏈方面。正如我之前提到的,隨著業務的推進,毛利率將面臨一些壓力。
On the other hand, we do also expect that our SG&A becomes even more efficient as we go forward, offsetting that. Now for the next couple of years, this year, we will be around 40%. And quarter four is usually a bit lower. Historically, we have been in the first nine months at 41%. So Q4 bring that in the range of around 40%.
另一方面,我們也預期隨著業務發展,我們的銷售、管理及行政費用將變得更加高效,從而抵銷這種影響。接下來幾年,包括今年,我們的佔比將維持在 40% 左右。第四季通常會略低一些。從歷史數據來看,前九個月的平均值為 41%。因此,第四季將這一比例提高到 40% 左右。
And then for the next two, three years, we said because of the Avidity proposed acquisition, 1 to 2 margin points down from the 40% and returning to 40% in 2029. So with that, basically -- but it's driven by development investments. And overall, to close that long answer on a short question, basically, the gross margin headwinds, I do expect to be offset by SG&A productivity.
然後,在接下來的兩三年裡,由於 Avidity 的擬議收購,我們預計利潤率將從 40% 下降 1 到 2 個百分點,並在 2029 年恢復到 40%。所以基本上就是這樣——但這主要是由發展投資所驅動的。總的來說,為了用簡短的回答結束這個冗長的回答,基本上,我預期毛利率的不利因素會被銷售、管理及行政費用的增加所抵銷。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
And then Sachin, was your second question around the anti-APRIL antibody, I didn't catch it.
然後 Sachin,你的第二個問題是關於抗 APRIL 抗體的,我沒有聽懂。
Sachin Jain - Analyst
Sachin Jain - Analyst
Yeah. Sorry, in the introduction, you talked about the strength of the existing IgAN launches, but I wonder if you could touch on the APRIL BAFF with data next year and how that wraps out your portfolio.
是的。抱歉,在引言中,您談到了現有 IgAN 上市產品的優勢,但我想知道您能否談談明年四月的 BAFF 上市數據,以及它如何完善您的產品組合。
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Yeah, absolutely. So first to note, ours is an anti-APRIL antibody. Our competitors are anti-APRIL, BAFF. And so I think one question, of course, will be to see the profile of those two drugs and does BAFF add anything and also differences in safety profile. But I would say, overall, we expect to see proteinuria in the range, we hope of what the others have seen.
是的,絕對是如此。首先要說明的是,我們研發的是一種抗 APRIL 抗體。我們的競爭對手反對 APRIL 和 BAFF。所以我認為,當然,一個問題是要看看這兩種藥物的特性,BAFF 是否能增加什麼作用,以及安全性方面的差異。但總的來說,我們預期蛋白尿的發生率會與其他患者所見的發生率相符。
And certainly, our Phase II data -- final Phase II data indicated we have very strong proteinuria reductions. We will be third to market in all likelihood. And so for us, it's really going to come down to a portfolio opportunity that we bring to patients, physicians, payers, firstly physicians' offices and payers because we'll have the opportunity to have an endothelin antagonist with Vanrafia.
當然,我們的 II 期數據——最終的 II 期數據表明,我們的蛋白尿減少非常顯著。我們很可能是第三個進入市場的。因此,對我們來說,這實際上將歸結為我們能夠為患者、醫生、支付方,首先是醫生辦公室和支付方帶來的產品組合機會,因為我們將有機會擁有Vanrafia這種內皮素拮抗劑。
We have the Factor B inhibitor with iptacopan and then with Fabhalta, and then we have the anti-APRIL antibody and bringing that entire solution set to the clinic and then also the opportunity for us to run combination studies. So we're already now evaluating what would be the right combination studies to run, generate that combination data so that nephrologists know what would be the right combination agents to optimize care for these patients.
我們有因子 B 抑制劑 iptacopan 和 Fabhalta,還有抗 APRIL 抗體,我們將把這套完整的解決方案帶到臨床,我們還有機會進行聯合研究。因此,我們現在已經在評估應該進行哪些合適的聯合研究,產生這些聯合數據,以便腎臟科醫生知道哪些聯合用藥可以優化這些患者的治療。
So these are all the opportunities I think we're looking at. But it's going to be important for us to think through those given that at least in the anti-APRIL space, we'll likely be third to market. Next question, Sharon. I think it's the last question, if I'm not mistaken.
所以,我認為我們正在考慮的就是這些機會。但對我們來說,仔細考慮這些問題非常重要,因為至少在反 APRIL 領域,我們很可能是第三個進入市場的。下一個問題,莎倫。如果我沒記錯的話,這應該是最後一個問題。
Operator
Operator
Stephen Scala, TD Cowen.
Stephen Scala,TD Cowen。
Steve Scala - Analyst
Steve Scala - Analyst
Oh, thank you so much. Given the proof of concept established by the CANTOS trial eight years ago, what new evidence compelled Novartis to go down the same pathway and acquire Tourmaline at this time?
哦,非常感謝。鑑於 CANTOS 試驗已在八年前證明其可行性,是什麼新證據促使諾華公司在此時走上同樣的道路並收購 Tourmaline 公司?
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Vasant Narasimhan - Chief Executive Officer, Member of the Executive Committee
Thank you, Good question, Steve. So I think we clearly understand that IL-1 beta and hitting the inflammasome has a powerful effect on cardiovascular risk reduction. But in that trial, where we did an all-comers study of patients who had a prior event without, I think, focusing down, you saw the challenge of having a significant CVRR. Now IL-6 has the opportunity to be a little bit further downstream of IL-1 beta.
謝謝你,史蒂夫,問得好。所以我認為我們已經清楚地認識到,IL-1β 和發炎小體對降低心血管風險具有強大的作用。但在那項試驗中,我們對所有曾發生過事件的患者進行了研究,我認為,沒有進行針對性研究,我們看到了獲得顯著 CVRR 的挑戰。現在 IL-6 有機會在 IL-1β 下游更進一步。
And the idea here is to get within the first few months to max six months to a year after an event when -- if patients are at that point in time with an elevated hsCRP, the knocking down that CRP can lead to a significant -- we believe the opportunity exists to lead to a significant impact on cardiovascular risk.
我們的想法是,在事件發生後的最初幾個月到最多六個月到一年內,如果患者的 hsCRP 水平升高,降低 CRP 水平可以帶來顯著的——我們相信,這有機會對心血管風險產生顯著影響。
So I think it's really -- we've learned from the CANTOS study. We understand a lot more about the biology based on that. And we think by targeting now prospectively patients right after an event who are at elevated CRP levels as a marker of elevated inflammation, we can then have a much more compelling cardiovascular risk reduction than the kind of 14%, 15% that we saw in the CANTOS study.
所以我覺得我們確實從 CANTOS 研究中學到了很多。基於此,我們對生物學有了更深入的了解。我們認為,透過現在就針對事件發生後 CRP 水平升高(作為發炎升高的標誌)的患者進行前瞻性研究,我們可以獲得比 CANTOS 研究中看到的 14%、15% 更令人信服的心血管風險降低。
Now we do have a competitor ahead of us, but a lot of our focus is designing, we think with our expertise, a study that can really maximize the opportunity for the IL -- the Tourmaline asset, the anti-IL-6. All right.
現在我們確實有一個競爭對手,但我們的許多精力都放在設計一項研究上,我們認為憑藉我們的專業知識,這項研究可以真正最大限度地發揮 IL(電氣石資產,抗 IL-6)的機會。好的。
Well, thank you all very much for attending two calls in two days, but we have another call coming day after tomorrow. So we hope you will attend that as well to learn more about our immunology portfolio. We will talk about Rhapsido. We'll talk about our Ianalumab data and importantly, also talk about our immune reset portfolio, which I think is quite exciting.
非常感謝大家兩天內參加兩次電話會議,但後天我們還有一次電話會議。所以我們希望您也能參加,以便更多地了解我們的免疫學產品組合。我們將討論狂想曲。我們將討論我們的 Ianalumab 數據,更重要的是,我們還會討論我們的免疫重置產品組合,我認為這非常令人興奮。
So thank you again for your interest in the company, and we look forward to catching up soon.
再次感謝您對本公司的關注,我們期待盡快與您見面。
Operator
Operator
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。