Novartis AG (NVS) 2024 Q3 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q3 2024 Results Release Conference Call and Live Webcast. (Operator Instructions)The conference is being recorded. (Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.

早上好，下午好，歡迎來到諾華 2024 年第三季業績發布電話會議和網路直播。 （操作員指令）會議正在錄音。 （操作員說明）電話會議的錄音（包括問答環節）將在通話結束後不久在我們的網站上提供。

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

接下來，我想將會議交給投資人關係主管 Sloan Simpson 女士。請繼續，女士。

Thank you so much. Good morning and good afternoon, everyone. Thank you for joining our Q3 2024 earnings call. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors.

太感謝了。大家早安，下午好。感謝您參加我們的 2024 年第三季財報電話會議。今天提供的資訊包含前瞻性陳述，涉及已知和未知的風險、不確定性和其他因素。

These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K that respectively were filed with and furnished to the US Securities and Exchange Commission.

這些可能導致實際結果與此類陳述明示或暗示的任何未來結果、績效或成就有重大差異。有關其中一些因素的說明，請參閱該公司分別向美國證券交易委員會提交和提供的 20-F 表格和 6-K 表格中的最新季度業績。

And with that, I will hand across to Vas.

接下來，我將把工作交給瓦斯。

Thank you, Sloan, and thanks, everyone, for joining today's webcast. So we'll dive right in. I have Harry Kirsch on the line with me as well as always.

謝謝斯隆，也謝謝大家參加今天的網路廣播。那麼我們就直接開始吧。哈里·基爾希（Harry Kirsch）一如既往地和我一起在線。

So moving to slide 4. You saw this morning that Novartis delivered strong operational performance in Q3, really continuing now what's been two years of very strong operating performance for the company. Sales grew 10%.

現在轉到幻燈片 4。銷售額成長 10%。

Core operating income was up 20% in constant currencies. In the quarter, our core margin went all the way up now to 40.1%. And we also had important innovation highlights, which we'll talk about a bit more over the course of the call. Kisqali's FDA approval and [CHMP] positive opinion in hormone receptor positive HER2-negative Stage II and III early breast cancer, our Fabhalta accelerated approval in IgA nephropathy.

以固定匯率計算，核心營業收入成長了 20%。本季度，我們的核心利潤率一路上升至 40.1%。我們還有重要的創新亮點，我們將在電話會議中詳細討論。 Kisqali 獲得 FDA 批准和 [CHMP] 對激素受體陽性 HER2 陰性 II 期和 III 期早期乳腺癌的積極意見，我們的 Fabhalta 加速了 IgA 腎病的批准。

So (inaudible) had its filing accepted for the PSMAfore population in metastatic castrate-resistant prostate cancer. And then we expect the Scemblix approval in the coming weeks. We received FDA priority review for first-line CML. And lastly and importantly, we had our third guidance raise for the year, raising both our top and bottom line guidance, and Harry will go through that in more detail.

因此（聽不清楚）其針對轉移性去勢抵抗性前列腺癌的 PSMAfore 族群的申請已被接受。我們預計 Scemblix 將在未來幾週內獲得批准。我們獲得了 FDA 對一線 CML 的優先審查。最後也是重要的是，我們今年第三次提高指導意見，提高了我們的頂線和底線指導意見，哈利將更詳細地介紹這一點。

So moving to slide 5. Q3 growth again reflected strong performance across our key growth drivers. You see 34% constant currency growth, which we expect to continue and help drive our 5% guide out to 2028. And also enable us to continue that strong margin expansion that you've seen. And let's go through each one of these brands in more detail.

因此，轉向幻燈片 5。您將看到34% 的持續貨幣成長，我們預計這種成長將持續下去，並有助於將我們的5% 指導方針推向2028 年。率擴張。讓我們更詳細地了解這些品牌中的每一個。

So moving to slide 6. Entresto sales continue to climb as they have now for multiple years, increasing 26% in Q3. It's the tenth year now of continued momentum on this brand, which I think really shows our ability to create large and lasting cardiovascular medicines. 25% TRx growth, 20% NBRx growth, 500,000 TRxs per month, ex-US, we're growing 26%. So we're confident in the growth up to the LOE. We have strong guideline positions in the US and EU.

現在轉到投影片 6。現在已經是這個品牌持續發展勢頭的第十個年頭了，我認為這確實表明了我們創造大型且持久的心血管藥物的能力。 TRx 成長 25%，NBRx 成長 20%，每月 50 萬 TRx，除美國外，我們成長了 26%。因此，我們對達到 LOE 的成長充滿信心。我們在美國和歐盟擁有強而有力的指導地位。

We continue to see very strong performance in hypertension in China, in Japan. We don't expect an LOE in Japan until 2031 at the earliest, and we continue to see protection for our business in China. For forecasting purposes, we maintain our guidance of the LOE for Entresto in the United States for mid-2025. And in the EU, regulatory data protection would expire in November of 2026.

我們繼續看到中國和日本在高血壓方面的表現非常強勁。我們預計最早要到 2031 年才會在日本獲得 LOE，並且我們在中國的業務將繼續受到保護。出於預測目的，我們維持對美國 Entresto 2025 年中期 LOE 的指導。在歐盟，監管資料保護將於 2026 年 11 月到期。

So moving to slide 7. Cosentyx grew 28%, and this was primarily driven by the strong performance we've had in our new launches in HS and in the IV formulation. You can see 28% growth overall, but driven by very strong performance in the United States of 38% outside the US, 16% in constant currencies. We remain the number one IL-17 in the US dynamic market, and we're the leading originator biologic now in the EU and in China.

轉到幻燈片 7。您可以看到整體成長 28%，但受到美國市場非常強勁的表現推動，美國以外地區成長 38%，以固定匯率計算為 16%。我們仍然是美國充滿活力的市場上排名第一的 IL-17，我們現在是歐盟和中國領先的生物製劑原廠藥。

In HS, we've achieved dynamic market leadership with over 60% NBRx share. In Germany, we're 50%, and we increasingly secured reimbursement in our key markets. So we see the opportunity to continue to grow dynamically in HS. We think we have an outstanding data profile even versus the incoming competitors. And we also see an opportunity for a market that's going to continue to expand, a market that's probably $3 billion plus today but has the potential to be a $5 billion-plus market over time or even larger depending on how patients continue to see their physicians.

在 HS 領域，我們以超過 60% 的 NBRx 份額實現了充滿活力的市場領導地位。在德國，我們的比例是 50%，我們在主要市場上獲得了越來越多的報銷。因此，我們看到了 HS 繼續動態成長的機會。我們認為，即使與即將到來的競爭對手相比，我們也擁有出色的數據概況。我們也看到了一個將繼續擴大的市場的機會，這個市場目前的規模可能超過30 億美元，但隨著時間的推移，市場有可能達到50 億美元以上，甚至更大，這取決於患者繼續看醫生的方式。

On -- in the IV, we have accelerated adoption in the US with over 1,250 accounts now ordering. That's a 52% growth. I think we'll continue to see more sales delivery in IV now that we have the permanent [J code]. But that, of course, will take time and we look forward to delivering that.

在 IV 中，我們加快了在美國的採用速度，現在已有超過 1,250 個帳戶訂購。增長了 52%。我認為既然我們有了永久的 [J 代碼]，我們將繼續在 IV 中看到更多的銷售交付。但這當然需要時間，我們期待實現這一目標。

We have two important LCM opportunities that will read out in 2025 in (inaudible) as well as in giant cell arteritis, both sizable indications that could give us even further opportunity to well exceed Cosentyx's $7 billion peak sales forecast.

我們有兩個重要的LCM 機會，將於2025 年在（聽不清楚）和鉅細胞動脈炎中讀出，這兩個重要的跡象可能會給我們帶來進一步的機會，遠遠超過Cosentyx 的70億美元高峰銷售預測。

Now moving to slide 8. (inaudible) continued to see strong demand globally, and it's a unique profile that this medicine provides for patients and physicians. So 28% growth. But when you strip out the onetime R&D adjustment that we had from a European market last year, our sales growth was 56% in constant currencies. We now have over 100,000 patients treated worldwide either naive or first switch. The US, our growth -- TRx volume growth was 38% versus prior year, gaining 3.7% share. Ex US, we had strong underlying growth, excluding the onetime R&D adjustment from last year.

現在轉到幻燈片 8。所以成長了28%。但如果剔除去年我們在歐洲市場進行的一次性研發調整，以固定匯率計算，我們的銷售額成長了 56%。目前，我們在全球範圍內有超過 100,000 名患者接受了初治或初次轉換治療。在美國，我們的成長——TRx 銷量比去年增長了 38%，份額增加了 3.7%。除美國外，不包括去年的一次性研發調整，我們的潛在成長強勁。

We also presented some important new data at [ECTRIMS] in the [ALETHIOS] trial, 90% of first-line Cosentyx patients had no disability progression in independent of relapse activity up to 6 years. And we had an additional study that demonstrated known new active lesions 12 months after switching from an anti-CD20 IV therapy. So we remain confident in the continued momentum on this brand. We're annualizing now well above $3 billion and have the opportunity, I think, to well exceed our $4 billion peak sales guidance to date.

我們也在 [ECTRIMS] 的 [ALETHIOS] 試驗中提供了一些重要的新數據，90% 的第一線 Cosentyx 患者在長達 6 年的時間裡沒有出現獨立於復發活動的殘疾進展。我們進行了另一項研究，證明從抗 CD20 IV 療法轉用 12 個月後已知有新的活動性病變。因此，我們對這個品牌的持續發展勢頭充滿信心。我們現在的年化收入遠高於 30 億美元，我認為，我們有機會遠遠超過迄今為止 40 億美元的高峰銷售指引。

To our knowledge, there are no Cosentyx biosimilars currently in clinical development, which should give us a long runway looking forward for this medicine.

據我們所知，目前尚無 Cosentyx 生物相似藥處於臨床開發階段，這應該讓我們對這種藥物有很長的期望。

Now moving to slide 9. Kisqali continued to cement its leadership in metastatic breast cancer and launched importantly in early breast cancer, as I mentioned. But perhaps most importantly, we achieved a category 1 [NCCN] guideline recommendation for the full Kisqali population. Overall growth in the quarter was 43%. US is up 50%. It's really gaining widespread adoption, our NBRx share at 48%. We're now second in TRx share overall. We have over 7,000 patients -- physicians are actively prescribing Kisqali and I think reflecting our strong guideline position.

現在轉到幻燈片 9。但也許最重要的是，我們為整個 Kisqali 人群實現了 1 類 [NCCN] 指南建議。該季度整體成長率為 43%。美國上漲了50%。它確實得到了廣泛的採用，我們的 NBRx 份額為 48%。我們現在在 TRx 總體份額中排名第二。我們有超過 7,000 名患者——醫生正在積極開出 Kisqali 處方，我認為這反映了我們強有力的指導立場。

Outside of the US, 36% constant currency growth as the preferred [CDK4/6] inhibitor in the class. We're leading -- have a leading share of 43% in those international markets and were the fastest-growing CDK4/6 in Europe.

在美國以外，作為同類中的首選 [CDK4/6] 抑制劑，匯率恆定增長 36%。我們處於領先地位——在這些國際市場上擁有 43% 的領先份額，並且是歐洲成長最快的 CDK4/6。

Now as I mentioned, the FDA approved Kisqali with a broad label fully in line with the population. CHMP has issued a positive opinion, and we're looking forward to a European Commission approval to allow us to launch in Europe. The Kisqali, if you go back to slide 9, the Category 1 guideline recommendation for the full study population, I believe, gives us the opportunity now to really fully realize the potential of this medicine, including a node-negative patients.

正如我所提到的，FDA 批准了 Kisqali 的廣泛標籤，完全符合人群。 CHMP 已發表積極意見，我們期待歐盟委員會批准我們在歐洲推出。 Kisqali，如果你回到幻燈片 9，我相信針對整個研究人群的 1 類指南建議讓我們現在有機會真正充分認識到這種藥物的潛力，包括淋巴結陰性患者。

In the early feedback we're getting from the market is very strong, the early scripts we're seeing, so a very strong trend, and we look forward to now building upon that as we get broad access for this medicine. We would expect access in the early breast cancer setting in the range of 90%, which is what we have for Kisqali in the metastatic setting.

在我們從市場獲得的早期反饋中，我們看到的早期腳本非常強勁，因此這是一個非常強勁的趨勢，我們期待在此基礎上繼續發展，因為我們可以廣泛使用這種藥物。我們預期早期乳癌的使用率在 90% 範圍內，這正是我們在轉移性乳癌中 Kisqali 的使用率。

Now moving to slide 10. As a reminder, Kisqali showed really strong deepening benefit and the update that we showed at [ESMO] When you look at the graph on the left, across the intention-to-treat population as well as Stage II and Stage III patients as well as a node-negative disease and a really strong 4-year IDFS absolute benefit that's consistent, consistent also across secondary endpoints. We have a trend of improved OS, which we expect to continue to deepen over time. No new safety signals were identified. So overall, we think we now have really the perfect positioning that we would want for Kisqali to succeed in the long run.

現在轉到投影片10。階段III 期患者以及淋巴結陰性疾病和真正強大的 4 年 IDFS 絕對獲益，這種益處在次要終點上也是一致的。我們有改進作業系統的趨勢，我們預計這種趨勢將隨著時間的推移而繼續深化。沒有發現新的安全訊號。總的來說，我們認為我們現在確實擁有完美的定位，從長遠來看，我們希望基斯卡利能夠取得成功。

As a reminder, the early breast cancer indication doubles the number of patients that are eligible for Kisqali versus the metastatic indication, and we estimate it is a 3x larger population than is currently labeled for the competitor product in the class in early breast cancer.

提醒一下，早期乳癌適應症使適合 Kisqali 的患者數量比轉移適應症的患者數量增加了一倍，我們估計其人數比目前早期乳癌類別中競爭對手產品的人數多了 3 倍。

Now moving to slide 11. Pluvicto continued what we would characterize a steady performance in the post-tax. Our focus at the moment is really laying the foundation for the PSMA 4 launch in 2025, which would triple the number of patients eligible for Pluvicto. We saw 50% growth in the quarter. When you adjust for the onetime price adjustment in Europe, our sales growth grew 36%. Just to provide more context that was true volume growth that we had in earlier quarters, as is always the case in certain European markets, our prices get adjusted over time. So that was the reason for the uplift we saw in Europe.

現在轉到投影片 11。我們目前的重點實際上是為 2025 年 PSMA 4 的推出奠定基礎，這將使符合 Pluvicto 資格的患者數量增加兩倍。我們看到本季成長了 50%。如果考慮到歐洲的一次性價格調整，我們的銷售額成長了 36%。只是為了提供更多背景信息，即我們前幾個季度的真實銷量增長，就像某些歐洲市場的情況一樣，我們的價格會隨著時間的推移進行調整。這就是我們在歐洲看到的經濟成長的原因。

Overall, we would expect Q4 to be broadly in line with Q3, excluding the [RD] adjustment. And I think for us now, it's really about preparing the market for Pluvicto [PSM4] opportunity. Our US field force has now expanded. We've launched a DTC to drive HCP and patient awareness. We now have 530 treatment sites in the US, which we feel like cover the key geographic areas. We will continue to expand that over time quite significantly. But we feel comfortable that we have capacity now to fully support the Pluvicto-PSMA4 launch, and we'll expand deeper into the community setting step by step.

總體而言，我們預計第四季將與第三季大致一致，不包括 [RD] 調整。我認為現在對我們來說，這實際上是為 Pluvicto [PSM4] 機會做好市場準備。我們的美國野戰部隊現已擴大。我們推出了 DTC 來提高 HCP 和患者的認識。我們現在在美國擁有 530 個治療點，我們認為這些治療點涵蓋了主要地理區域。隨著時間的推移，我們將繼續大幅擴展這一範圍。但我們感到放心的是，我們現在有能力全力支持 Pluvicto-PSMA4 的發布，我們將逐步深入社區環境。

Our ex-US launch is progressing well with good pricing and reimbursement discussions. And so we feel very good about where we are to prepare for that launch next year.

我們在美國以外的推出進展順利，定價和報銷討論良好。因此，我們對明年的發布準備感到非常滿意。

In terms of new indications and geographies, the PSMA 4 filing was accepted by FDA. We're preparing for a launch in the first part -- first half of 2025. In China, both the [post-taxane] and in Japan, the pre and post taxing submissions have happened. We're in the midst of building up manufacturing facilities in both of those markets as we expect them to be sizable opportunities. the PSMA Edition and PSMA DC studies are progressing according to plan.

在新適應症和地理方面，PSMA 4備案已被FDA接受。我們正在準備第一部分——2025 年上半年的發布。我們正在這兩個市場建立製造設施，因為我們預計它們將帶來巨大的機會。 PSMA 版本和 PSMA DC 研究正在按計劃進行。

And we have also begun construction of two additional facilities in the US to support our expanding RLC portfolio, which now includes multiple additional programs that have entered the clinic, including assets such as a B7-H3 actinium RLT as well as HER2 RLT and a [folate] RLT, all of which now either have first patient (inaudible) or will soon have first patient first visit, giving us a broad portfolio that we need to now prepare for.

我們也開始在美國建造另外兩個設施，以支持我們不斷擴大的 RLC 產品組合，其中包括已進入臨床的多個其他項目，包括 B7-H3 錒 RLT 以及 HER2 RLT 和 [葉酸] RLT，所有這些現在要嘛有第一位患者（聽不清楚），要嘛很快就會有第一位患者首次就診，為我們提供了現在需要準備的廣泛投資組合。

Moving to slide 12. Leqvio continued its strong growth trend with accelerating adoption outside of the US And we're very pleased by both the solid US performance but that acceleration that we're seeing in our international markets. We have continued growth that's outpacing the overall advanced lipid lowering market. 4,600 facilities have ordered Leqvio, which is a substantial increase versus prior year. We see demand increasing across all channels. And I'd say our targeting strategy in the US to really focus on patients and physicians that are treated in the post-event setting where there's a high propensity to add an additional lipid-lowering therapy has worked really well.

轉到幻燈片 12。我們的持續成長超過了整個先進降脂市場。 4,600 家工廠訂購了 Leqvio，與去年相比大幅增加。我們看到所有管道的需求都在增加。我想說的是，我們在美國的目標策略是真正關注在事件後接受治療的患者和醫生，這些患者和醫生很可能會增加額外的降血脂治療，效果非常好。

Now outside of the US, we're reimbursed in 39 countries commercially available in 73. And as I said, we're seeing steady and strong uptake, particularly in markets such as Japan, where we recently launched, and our launch is well exceeding our expectations.

現在，在美國以外，我們在39 個國家/地區進行了報銷，並在73 個國家/地區上市。在日本推出了這款產品，而且我們的推出遠遠超過了我們的期望。

Now adding to the overall Leqvio body of evidence, we did read out the trial, which demonstrated superiority as [Leqvio] in both placebo and [ezetimibe] versus placebo and ezetimibe and LDL-C reduction. And we are looking over time to think about how we can further expand Leqvio into the monotherapy or frontline indication, depending on the geography.

現在，添加到Leqvio 的整體證據中，我們確實宣讀了該試驗，該試驗證明了[Leqvio] 在安慰劑和[依折麥布] 方面均優於安慰劑和依折麥布以及降低LDL-C方面的優越性。我們正在考慮如何根據地理位置進一步將 Leqvio 擴展到單一療法或第一線適應症。

So moving to slide 13. Scemblix grew 72% in quarter 3. As you know, it has really become a preferred option for a third line. It's the market leader in NBRx and TRx across geographies with 26% TRx share growth. It's driven by 18% quarter-over-quarter demand. Outside of the US, we see a very strong sales trajectory for the product with total market -- with a growing total market share and growing prescriber base. And that's critical for us to continue to build that strong base in third line because as we approach the first-line launch, those physicians get more and more comfortable with the overall profile of Scemblix.

因此，轉到幻燈片 13。它是各個地區 NBRx 和 TRx 的市場領導者，TRx 份額增加了 26%。這是由環比 18% 的需求所推動的。在美國以外，我們看到該產品的整個市場銷售軌跡非常強勁——總市場份額不斷增長，處方者基礎不斷擴大。這對於我們繼續在第三線建立強大的基礎至關重要，因為隨著我們接近一線上市，這些醫生對 Scemblix 的整體概況越來越滿意。

So as I mentioned, we have FDA priority review. We do expect the approval in the coming weeks. We're fully prepared for launch. We're also fully prepared to obtain rapid market access to really ensure a rapid launch in the US and eventually around the world. And outside of the US, China and Japan submissions have now been completed, and we're also on track for a European submission in 2025.

正如我所提到的，我們有 FDA 優先審查。我們預計將在未來幾週內獲得批准。我們已為發布做好充分準備。我們也做好了充分準備，以獲得快速的市場准入，以真正確保在美國乃至全世界的快速推出。在美國以外，中國和日本的提交現已完成，我們也預計在 2025 年在歐洲提交。

Now moving to slide 14. [Colpalta], it's early days, but we are pleased by the performance in GNH ultrarare disease, not a lot of cycling of these patients. So it will take time to build this brand. But as the only monotherapy -- oral monotherapy to provide extravascular and intravascular hemolysis control, we're seeing strong launch performance overall. We see a high compliance and continuation rate on the medicine. We have over 70% coverage to label. We have NBRx now of over 30%. And outside of the US as well, we're seeing solid early signs of success with good patient activation with over 1,000 HCPs now reached in the first 3 months post launch.

現在轉到幻燈片 14。所以建立這個品牌需要時間。但作為唯一提供血管外和血管內溶血控制的單一療法——口服單一療法，我們看到整體表現強勁。我們看到該藥物的依從性和持續率很高。我們的標籤覆蓋率超過 70%。我們現在的 NBRx 已經超過 30%。在美國以外，我們也看到了成功的堅實早期跡象，患者積極參與，在推出後的前 3 個月內已有超過 1,000 名 HCP 參與。

We're seeing utilization across naive and switch basins. And we also have recent launches in Japan, U.K., and we were granted early access as well in France. So taken together, early days, but step by step, this is an important building block as we build (inaudible) across multiple indications to be over a $3 billion-plus medicine over time.

我們看到了幼稚盆地和開關盆地的使用率。我們最近也在日本、英國推出了產品，並且在法國也獲得了搶先體驗權。因此，早期但一步一步地綜合起來，這是一個重要的組成部分，隨著時間的推移，我們將跨越多種適應症（聽不清楚）打造價值超過 30 億美元的藥品。

Moving to slide 15. In addition, they received the accelerated approval in the US as the first and only complement inhibitor in IgA nephropathy. That was based on the positive interim results of the applause Phase III study. The study is continuing to the confirmatory endpoint of [eGFR] at 24 months. We expect the completion date in 2025.

轉到幻燈片 15。這是基於掌聲第三階段研究的正向中期結果。研究正在繼續進行，直至 24 個月時確定 [eGFR] 終點。我們預計竣工日期為 2025 年。

We see very positive HCP feedback on the efficacy and safety and understanding of the role of the complement pathway in this disease. We also see important early signs from a utilization standpoint. Over 1,000 [ACPs] are now REMS certified, and we're leveraging our portfolio to ensure that we have broad and quick access for this medicine.

我們看到 HCP 對補體途徑在該疾病中的功效和安全性的反饋以及對補體途徑作用的理解非常積極。從利用率的角度來看，我們也看到了重要的早期跡象。超過 1,000 個 [ACP] 現已獲得 REMS 認證，我們正在利用我們的產品組合來確保我們能夠廣泛、快速地獲得這種藥物。

Perhaps most importantly, we're seeing patients with a positioning of this medicine for patients with persistent [proteinuria] and glomerular inflammation as really getting traction in the marketplace. And that's enabling us to maintain the price of (inaudible) consistent with the PNH indication which will also be important for the subsequent indications that we have for [Populsa], including C3G.

也許最重要的是，我們看到這種藥物針對持續性[蛋白尿]和腎小球發炎患者的定位確實在市場上受到關注。這使我們能夠保持（聽不清楚）與 PNH 指示一致的價格，這對於我們為 [Populsa] 提供的後續指示（包括 C3G）也很重要。

And if we go to the next slide, slide 16, we released results over the weekend of the 12-month APR C3G data at ASN. On the left-hand side, you see the sustained proteinuria reduction over 12 months and that, that was replicated in the placebo arm after switch to (inaudible). So that was very positive and something the regulators had asked us for.

如果我們轉到下一張投影片，即投影片 16，我們在 ASN.1 上週末發布了 12 個月 APR C3G 數據的結果。在左側，您可以看到蛋白尿在 12 個月內持續減少，並且在切換至安慰劑組後，這一情況在安慰劑組中得到了複製（聽不清楚）。所以這是非常正面的，也是監管機構要求我們做的事情。

But importantly as well, we're seeing stabilization of the eGFR slope versus the historic slope decline, and that's been maintained now for 12 months. So we're seeing the important outcome measure as well, very positive data.

但同樣重要的是，我們看到 eGFR 斜率相對於歷史斜率下降趨於穩定，而這種情況已經維持了 12 個月。因此，我們也看到了重要的結果指標，非常正面的數據。

So we have ongoing health authority reviews in the EU and other countries. And we expect to make the submission now in the US before the end of the year.

因此，我們正在歐盟和其他國家進行衛生當局審查。我們預計將在今年年底前在美國提交申請。

So moving to slide 17. Overall, we had good progress on our innovation milestones. We did suffer a few setbacks. With [XXB], we will terminate this program we saw a safety signal in heart failure. And overall, the hypertension, blood pressure reduction we saw on top of standard of care was not sufficient to meet the TPP we think we need to achieve for this medicine. So we'll be stepping back and focusing on our [siRNAs] for hypertension as well as other assets we have in our cardiovascular portfolio.

現在轉到投影片 17。我們確實遭受了一些挫折。透過[XXB]，我們將終止該計劃，我們在心臟衰竭中看到了安全訊號。總體而言，我們在標準護理之外看到的高血壓和血壓降低不足以滿足我們認為該藥物需要實現的 TPP。因此，我們將退後一步，專注於治療高血壓的 [siRNA] 以及我們在心血管產品組合中擁有的其他資產。

So with that, let me hand it over to Harry.

那麼，讓我把它交給哈利。

Yes. Thank you, Vas. Good morning, and good afternoon, everyone. I will now talk you through our financials for the third quarter and the first 9 months, which were very strong. As always, my comments refer to continuing operations and growth rates in constant currencies, unless otherwise noted.

是的。謝謝你，瓦斯。大家早安，下午好。現在我將向您介紹我們第三季和前 9 個月的財務狀況，這些財務狀況非常強勁。像往常一樣，除非另有說明，我的評論指的是以固定貨幣計算的持續營運和成長率。

On slide 19, it's a pleasure to present results like those that we have on slide 19. I think you hopefully agree with that. Quarter 3, net sales grew 10%. Core operating income was up 20%. Our core margin, as Vas already mentioned, 40.1%, which reflects a 340 basis point improvement versus prior year. Core EPS was $2.06, also up 20%, and free cash flow was basically $6 billion, the highest we have ever achieved in any one quarter. For 9 months, net sales grew 11% and core operating income was also up 20%, when the core margin increased to 39.4% in the first 9 months, demonstrating continued good or very good progress towards achieving our midterm margin guidance of 40% plus by 2027. Core EPS was $5.83, up 21%. And the free cash flow in the first 9 months grew 15% to [$12.6 billion].

在投影片 19 上，我們很高興展示與投影片 19 上的結果類似的結果。第三季淨銷售額成長 10%。核心營業收入成長20%。正如 Vas 已經提到的，我們的核心利潤率為 40.1%，比去年提高了 340 個基點。核心每股收益為 2.06 美元，也成長了 20%，自由現金流基本上為 60 億美元，是我們在任何一個季度取得的最高水準。 9 個月內，淨銷售額成長了11%，核心營業收入也成長了20%，前9 個月核心利潤率增至39.4%，這顯示我們在實現40% 以上的中期利潤率指引方面持續取得良好或非常良好的進展到 2027 年。前 9 個月的自由現金流成長了 15%，達到 [126 億美元]。

Now on to the next slide, please. Our continued strong business momentum, together with operating efficiencies despite the many launches we are fully funding and of course, the R&D pipeline, allowed us to once again raise our full year guidance on both top and bottom line, which you will see on slide 20. We now expect sales to grow low double digits from high single to low double digits previously, and we expect core operating income to grow the high teens from mid- to high teens previously.

現在請轉到下一張投影片。儘管我們為許多產品的推出提供了全額資金，當然還有研發管道，但我們持續強勁的業務勢頭以及營運效率，使我們能夠再次提高全年營收和利潤指引，您將在幻燈片20 中看到我們現在預計銷售額將從先前的高個位數成長到低兩位數，我們預計核心營業收入將從先前的中雙位數成長到高雙位數。

Embedded in our guidance is the key assumption that there will be no (inaudible), (inaudible) and generic entries in 2024. And we also expanded a bit so that you can start with the modeling for next year, and we make an assumption that these generic entries in US will happen in the middle of 2025 for forecasting purposes. And to complete our full year guidance is always the other two components from(inaudible) down to (inaudible) EPS. Please note that we expect core net financial expenses to be around [$0.7 billion] for the full year. And our core tax rate continues to be around 16.2%.

我們的指南中包含一個關鍵假設，即2024 年將不會有（聽不清楚）、（聽不清楚）和通用條目。如下假設：出於預測目的，美國的這些通用條目將在 2025 年中期發生。完成我們的全年指導始終是從（聽不清楚）到（聽不清楚）每股收益的其他兩個組成部分。請注意，我們預計全年核心淨財務支出約為[7 億美元]。我們的核心稅率仍在16.2%左右。

Moving to slide 21. We remain committed to our shareholder-friendly capital allocation strategy to invest in the business whilst also returning attractive shareholder returns. In the first 9 months, we executed multiple bolt-on M&A and (inaudible) deals, particularly to strengthen our RLT platform, our regional pipeline and AI capabilities. In addition to having invested, of course, in our internal R&D engine.

轉到投影片 21。在前 9 個月中，我們執行了多項補充併購和（聽不清楚）交易，特別是為了加強我們的 RLT 平台、區域管道和人工智慧能力。當然，除了投資我們的內部研發引擎之外。

In terms of returning capital to shareholders, we paid our growing annual dividend of (inaudible) per share in Swiss franc this time, $7.6 billion in March of this year. And we also continued our [$15 billion] share buyback which has approximately [$8 billion] left to be executed by the end of 2025.

在向股東返還資本方面，我們這次以瑞士法郎支付了不斷增長的每股（聽不清楚）年度股息，今年 3 月為 76 億美元。我們也繼續進行 [150 億美元] 股票回購，到 2025 年底，還有大約 [80 億美元] 待執行。

Now on to my final slide already, where we have outlined details regarding the expected currency impacts. In quarter 3, FX had a mild negative 1 percentage point impact on net sales, a negative 3% points on core operating income, of course, driven by (inaudible) dollar strengthening, but also, of course, on the bottom line due to our Swiss franc cost base.

現在已經到了我的最後一張投影片，我們概述了有關預期貨幣影響的詳細資訊。在第三季度，外匯對淨銷售額產生了輕微的負1 個百分點的影響，對核心營業收入產生了3 個百分點的負影響，這當然是受到（聽不清）美元走強的推動，但當然，也由於我們的瑞士法郎成本基礎。

If late October rates were to prevail for the remainder of 2024, we would expect full year currency impact to be again around 1% negative on net sales and negative 3 to 4 percentage points on core operating income. As we already start to look forward into 2025 begin to inform your modeling assumptions, we expect a negative (inaudible) point impact on net sales and negative 2 percentage points on core operating income. Again, if currencies stay for next year where they are right now.

如果 2024 年剩餘時間內繼續採用 10 月底的利率，我們預期全年匯率影響將再次對淨銷售額產生約 1% 的負面影響，對核心營業收入產生負面影響 3 至 4 個百分點。由於我們已經開始展望 2025 年並開始告知您的建模假設，因此我們預計淨銷售額將受到負面（聽不清楚）1 個百分點的影響，核心營業收入將受到負面 2 個百分點的影響。同樣，如果明年貨幣保持在現在的水平的話。

Of course, as we all know, currencies move every minute. And so we will give (inaudible) to predict this from outside of the company each month. In the middle of the month, we will give you an update, which is posted on the website. So you always have that element of the forecast as well. And so thank you for your interest, of course, and back to you, Vas.

當然，眾所周知，貨幣每分鐘都在波動。因此，我們每個月都會從公司外部進行（聽不清楚）預測。本月中旬，我們將向您提供更新信息，並將其發佈在網站上。所以你總是有預測的這個元素。當然，感謝您的關注，也感謝您，Vas。

Great. Thank you, Harry. So moving to slide 24. In summary, we see continued strong business momentum in the quarter and I think the numbers speak for themselves, the 10% and the 20% growth. We raised our full year 2024 guidance for the third time just showing the underlying momentum we're seeing across our growth drivers and new launches. We continue to deliver on our pipeline building off of 10 Phase III readouts in positive Phase III readouts with indication expansions of Kisqali (inaudible) in the submission of (inaudible), and we're well on track to achieve our midterm guidance of 5% sales growth, [23 to 28] and 40% plus operating income margin by 2027.

偉大的。謝謝你，哈利。現在轉到投影片 24。我們第三次上調 2024 年全年指引，這只是顯示了我們在成長動力和新產品推出方面看到的潛在動力。我們繼續在10 個第三階段讀數的基礎上交付我們的管道，在第三階段讀數中進行積極的讀數，並在提交（聽不清）中對Kisqali（聽不清）進行適應症擴展，並且我們預計將實現5% 的中期指引到 2027 年，銷售成長 [23 至 28]，營業利潤率將增加 40%。

So moving to my last slide, we also wanted to just (inaudible) for all of you. We will have Meet Novartis Management on November 20 and 21 in London. It will be a great opportunity for our investors to meet our leadership teams across the company with a focus on our TA leaders in R&D. We'll also be able to provide an update on our '23 to '28 midterm guidance as well as a '24 to '29 sales guidance as well. And then lastly, we'll also provide an update on the peak sales outlook for many of our brands, which continue to have really strong momentum.

因此，轉到我的最後一張投影片，我們也想（聽不清楚）為大家服務。我們將於 11 月 20 日至 21 日在倫敦與諾華管理層會面。對於我們的投資者來說，這將是一個與整個公司的領導團隊會面的絕佳機會，重點是研發領域的技術援助領導者。我們還將能夠提供 '23 至 '28 中期指導以及 '24 至 '29 銷售指導的更新。最後，我們還將提供我們許多品牌的峰值銷售前景的最新訊息，這些品牌仍然保持著強勁的勢頭。

So with that, operator, we can open the line for questions.

這樣，接線員，我們就可以打開提問線路了。

(Operator Instructions)

（操作員說明）

Richard Vosser from JPMorgan.

摩根大通的理查‧沃瑟。

It's a question on the impact of coverage gap reform on the business in '25. I'm particularly thinking about the impact on Cosentyx and Entresto. If you could give us any color on how that's panning out, that would be great.

這是關於覆蓋差距改革對 25 年業務的影響的問題。我特別考慮對 Cosentyx 和 Entresto 的影響。如果您能給我們任何有關進展的信息，那就太好了。

Yes. Thanks, Richard. And I also want to add, we should have one question. I thank you for adhering to that already, Richard, but one question per person, and then we'll cycle through the list as many times as we can.

是的。謝謝，理查。我還想補充一點，我們應該要有個問題。我感謝你已經遵守了這一點，理查德，但每人一個問題，然後我們將盡可能多次地循環瀏覽該列表。

So in terms of the coverage GAAP reform, there's going to be pushes and pulls, which we'll have to understand better over the course of 2025. On the positive side, we'll see how demand generation increased with the 20% out-of-pocket cap, especially depending on how many patients sign up for the smoothing, you could see that those impacts happening relatively early in the year, but that's something we'll have to see how it ultimately plays out on the positive side.

因此，就GAAP 改革的覆蓋範圍而言，將會出現推動和拉動，我們必須在2025 年更好地理解這一點。增加。

In terms of headwinds, certainly, our cost sharing within the system will go up, and that's something we'll have to manage. But on the flip side, our patient support programs also should be adjusted down given the number of patients who would qualify. I would not no longer qualify given adjustments given the IRA being in place. So net-net, we see this as neutral to slightly negative, but that's already factored into the guidance that we've given for the long run. So that's already in the 5% up to ['28]. So a material impact on how we look at the business. And I think we're going to learn more over the course of the year.

當然，就不利因素而言，我們在系統內分攤的成本將會上升，這是我們必須管理的。但另一方面，考慮到符合資格的患者數量，我們的患者支持計畫也應該下調。鑑於 IRA 已經到位，我將不再有資格進行調整。因此，我們認為這是中性到輕微負面的，但這已經考慮到我們給出的長期指導中。所以這已經是 ['28] 之前的 5%。因此，這對我們如何看待業務產生了重大影響。我認為我們將在這一年中學到更多。

Emily Field from Barclays.

巴克萊銀行的艾米麗·菲爾德。

Emily Field Barclays Bank

艾米莉·菲爾德巴克萊銀行

I was just wondering when you'd expect some of these new promotional efforts to have an impact on political patient growth in the US in the vision population? Or should we more expect sales to really start to grow again once [PSMA4as] launched, I believe, early in the year, you said that, that launch would be an inflection in sales. So any color you can provide would be helpful.

我只是想知道您何時預期這些新的促銷活動會對美國視力族群中政治耐心的成長產生影響？或者，我們是否應該更期望一旦 [PSMA4as] 推出，銷售額就會真正開始再次成長，我相信，在今年年初，您說過，該推出將是銷售額的一個轉折。因此，您可以提供的任何顏色都會有所幫助。

Yes. Thanks, Emily. So we know in terms of the time lines for those investments, we started the DTC in September. We got the full field force out really in the August, September time frame. So it usually takes 6 months before you see any impact for those expansions and investments. So I think for us right now, we want to maintain the vision population. We always guided to vision to be about a $2 billion peak sales globally. So in the US, we're already annualizing in that kind of [1.2 to 1.4] range. We expect as we bring China, Japan and other markets on board, we can reach that $2 billion over time.

是的。謝謝，艾米麗。因此，我們知道這些投資的時間表，我們在 9 月啟動了 DTC。我們在八月、九月的時間範圍內真正調動了全部現場人員。因此，通常需要 6 個月的時間才能看到這些擴張和投資的影響。所以我認為現在對我們來說，我們希望維持有視力的人群。我們始終將全球銷售額高峰設定為約 20 億美元。因此，在美國，我們已經在 [1.2 至 1.4] 的範圍內進行年化。我們預計，隨著中國、日本和其他市場的加入，我們的目標將隨著時間的推移達到 20 億美元。

But the real inflection for this medicine is the tripling of the patient population with [GSMA 4] and then a further large addition of additional patients with the HSPC PSMA addition studies. So we've got to make sure that we have adequate capacity, which we feel pretty good about in terms of of bed capacity. A lot of our work now is getting the referral systems in place to ensure that community oncology understands how they can refer, when to refer to be able to get Pluvicto and get those patients also then back to community oncology. Also making sure that large academic centers are prepared for what we expect will be a surge of patients on the approval of (inaudible)

但該藥物的真正變化是 [GSMA 4] 患者人數增加了兩倍，然後透過 HSPC PSMA 附加研究進一步增加了更多患者。所以我們必須確保我們有足夠的容量，我們對床位容量感到非常滿意。我們現在的大量工作是建立轉診系統，以確保社區腫瘤科了解如何轉診、何時轉診，以便能夠獲得 Pluvicto 並讓這些患者返回社區腫瘤科。也要確保大型學術中心為我們預期的患者激增做好準備（聽不清楚）

so all of that work is very much in focus, but I wouldn't expect a significant inflection point before we get PSMA 4 fully launched.

因此，所有這些工作都非常受關注，但我預計在 PSMA 4 全面啟動之前不會出現重大轉折點。

Florent Cespedes from Bernstein.

伯恩斯坦的弗洛倫特·塞斯佩德斯。

A quick one on 2025, I know it's early days and you won't provide any guidance. But could you remind us which are the main tailwinds and headwinds for next year? And how you see this challenging year given the generics expected to be launched mid-2025?

快速介紹一下 2025 年，我知道現在還為時過早，您不會提供任何指導。但您能否提醒我們明年的主要有利因素和不利因素是什麼？鑑於預計將於 2025 年中期推出仿製藥，您如何看待這項充滿挑戰的一年？

Yes. Thanks, Florent. Obviously, we don't provide guidance until January. But I can say we're confident we'll grow top and bottom line, and we'll provide more color on that, obviously, in January.

是的。謝謝，弗洛倫特。顯然，我們要到一月份才會提供指導。但我可以說，我們有信心實現營收和利潤的成長，顯然，我們將在一月份提供更多的資訊。

When you think about the tailwinds that we have, it's clearly the new indications and launches. I mean you've already seen Cosentyx is continuing to have strong performance in HS and IV. We, of course, have (inaudible) the Kisqali early breast cancer with a broad label and a broad NCCN Guideline, we're in the early days of the (inaudible) launch with the (inaudible), both in PNH and IgAN, we expect to accelerate over the course of next year. Importantly, the Scemblix first-line launch in CML will continue to allow us to expand that drug hopefully substantially. And then, of course, Kesimpta, you've seen is already on just a steady, strong pace and Kisqali and metastatic breast cancer also in a really strong pace. And then Entresto, outside of the US, also with continued strong performance.

當你想到我們所擁有的有利因素時，你會發現這顯然是新的適應症和新產品的推出。我的意思是您已經看到 Cosentyx 在 HS 和 IV 中繼續表現強勁。當然，我們有（聽不清楚）Kisqali 早期乳癌，具有廣泛的標籤和廣泛的 NCCN 指南，我們正處於（聽不清楚）在 PNH 和 IgAN 中推出（聽不清楚）的早期階段，我們預計明年將加速。重要的是，Scemblix 一線治療 CML 的上市將繼續讓我們有望大幅擴展該藥物。當然，您已經看到 Kesimpta 已經在穩步、強勁地發展，Kisqali 和轉移性乳癌也以非常強勁的速度發展。然後，Entresto 在美國以外的地區也表現持續強勁。

I think the biggest headwinds we're going to have, as we noted, is the LOEs that we currently forecast for forecasting purposes for mid of next year on to (inaudible) and Entresto. Of course, it depends on how those ultimately all the various litigations go and whether our products are appropriately -- are approved, et cetera, but that's our current forecasting guidance on those medicines.

正如我們所指出的，我認為我們將面臨的最大阻力是我們目前預測的明年中期（聽不清楚）和 Entresto 的 LOE。當然，這取決於最終所有各種訴訟的進展以及我們的產品是否適當地獲得批准等等，但這是我們目前對這些藥物的預測指導。

But beyond that, we see continued opportunities for strong margin performance, strong free cash flow performance. we feel very good with where the business is. So I think we can navigate that. And as we said all along, we factor those patents in (inaudible) those LOEs into that 5% plus guidance up to '28. So it's well captured in our long-term guidance, and we'll navigate it and continue to grow the company strongly.

但除此之外，我們也看到了強勁的利潤率表現和強勁的自由現金流表現的持續機會。我們對業務所在地感到非常滿意。所以我認為我們可以解決這個問題。正如我們一直以來所說的，我們將那些（聽不清楚）LOE 中的專利納入 5% 以上的指引（截至 28 年）。因此，我們的長期指導充分體現了這一點，我們將駕馭它並繼續強勁地發展公司。

Simon Baker from Redburn Atlantic.

來自雷德伯恩大西洋公司的西蒙貝克。

One on Cosentyx and HS, if I may. You've seen a very, very fast adoption in HS, which is testament to the superiority. Cosentyx over previous treatment options. But there were quite a few behind Cosentyx coming into HS. So I just wondered if you could update us on your thoughts on the competitive dynamics there? How long do you expect that preeminence of Cosentyx to persist, bearing in mind what is coming behind over the next 12 to 18 months?

如果可以的話，一篇關於 Cosentyx 和 HS 的文章。您已經看到 HS 的採用速度非常非常快，這證明了其優越性。 Cosentyx 優於先前的治療方案。但在 Cosentyx 進入 HS 市場之後，還有相當多的公司落後。所以我想知道您是否可以向我們介紹一下您對那裡競爭動態的最新想法？考慮到未來 12 至 18 個月的情況，您預計 Cosentyx 的卓越地位會持續多久？

Yes. I mean, look, we -- Simon, thanks for the question. We continue to expect Cosentyx to be over $1 billion plus in HS. And the reasons we have that conviction, as you noted as well, there's a tremendous support for Cosentyx amongst dermatologists. We're very comfortable using this medicine given the long period of time that it's been on the market and successfully used.

是的。我的意思是，聽著，我們──西蒙，謝謝你的提問。我們仍然預計 Cosentyx 的 HS 銷售額將超過 10 億美元。正如您所指出的，我們之所以有這樣的信念，是因為皮膚科醫生對 Cosentyx 給予了巨大的支持。鑑於這種藥物已經上市並成功使用了很長一段時間，我們對它的使用感到非常滿意。

But the other thing is I think there's confusion in the market in terms of the comparison of Cosentyx to the IL-17 [AF] in psoriasis versus what at least we see in HS. Importantly, in HS, when you look at the HIS CR 50, you have pretty comparable results -- cross-trial comparisons are always, of course, challenging different patient population. So you have to be taken with appropriate caution. But very similar.

但另一件事是，我認為市場上對於 Cosentyx 與 IL-17 [AF] 治療銀屑病與至少我們在 HS 中看到的比較存在混淆。重要的是，在 HS 中，當您查看 HIS CR 50 時，您會得到相當可比的結果——當然，跨試驗比較總是對不同的患者群體提出挑戰。因此，您必須謹慎行事。但非常相似。

And then when you look at [flares] in our study, we had 60% of patients free of (inaudible). And in pain, we showed a meaningful reduction of 50% for these patients in pain. I would encourage the investor base to look at that data versus the competitor entry. And I think that would enable us to have really a strong clinical positioning on top of the strong account positioning and long history that we have.

然後，當您查看我們研究中的[耀斑]時，我們有 60% 的患者沒有（聽不清楚）。在疼痛方面，我們發現這些患者的疼痛明顯減少了 50%。我鼓勵投資者將這些數據與競爭對手的數據進行比較。我認為這將使我們能夠在強大的客戶定位和悠久的歷史基礎上擁有真正強大的臨床定位。

So then really, the focus is in a growing market with additional patients who hopefully will come in. Can we continue to maintain a strong share position, given that data, given our access position which is why we think because HS will be a very substantial opportunity for the medicine. But I think that distinction between psoriasis and HS data is absolutely crucial for everyone to understand.

因此，實際上，重點是一個不斷成長的市場，有更多的患者希望能夠進入。將是一個非常重要的市場的原因。但我認為銀屑病和 HS 數據之間的區別對於每個人的理解絕對至關重要。

Graham Parry, Bank of America.

格雷厄姆·帕里，美國銀行。

Question on Pluvicto. So the flat fourth quarter guide implies no growth ex US as well as in the US So I understand US centers are pretty fully penetrated in the vision population, but why no growth ex U.S?

關於普魯維克託的問題。因此，第四季指南持平意味著美國以外地區和美國國內都沒有成長。

And on PSMA 4. I just wondered why you didn't use a priority (inaudible) or attempt to accelerate the review there in any way?

關於 PSMA 4。

Yes. Thanks, Graham. So on Pluvicto, so I think ex US right now, we do continue to see growth generation, but of course, with the pricing dynamics as we continue to work to secure the final pricing, we don't expect that to translate yet into revenues. And then I think China and Japan will be absolutely critical to really get the ex US going.

是的。謝謝，格雷厄姆。因此，在 Pluvicto 上，我認為目前除美國外，我們確實繼續看到成長，但當然，隨著我們繼續努力確保最終定價，我們預計這不會轉化為收入。然後我認為中國和日本對於真正推動前美國的發展絕對至關重要。

In Europe, we're primarily focused in Germany and France, and we have ongoing negotiations in those markets regarding the pricing situation. So I think that's why we want to be realistic and say, in addition to that dynamic, we also have the holiday period in the US We know from prior years that for Pluvicto, Thanksgiving and the Christmas holidays, is not a time that patients want to initiate therapy because post dose, they can't be around family or on children. At least that's the current guideline. Whether biologically sensible or not is irrelevant. That's the current guidance. So that leads to a few weeks that we lose in quarter 4 always.

在歐洲，我們主要關注德國和法國，我們正在這些市場就定價情況進行談判。所以我認為這就是為什麼我們要現實一點，除了這種動態之外，我們在美國也有假期。 我們從前幾年知道，對於 Pluvicto、感恩節和聖誕節假期，不是患者想要的時間開始治療，因為服藥後，他們不能在家人或孩子身邊。至少這是當前的指導方針。生物學上是否合理並不重要。這就是當前的指導。因此，這導致我們在第四季總是會輸掉幾週的時間。

So taking all of that together, we think it's reasonably and prudent to provide guidance that will be in line net of the adjustment.

因此，綜合考慮所有因素，我們認為提供扣除調整後的指導是合理且謹慎的。

Now in terms of [PluvictoPSMA4], we chose not to use a priority review voucher purely because we had discussions with the FDA. The FDA view was, given that we'll provide the 100% OS during the review period, they wanted flexibility for the timing to review that data. Now hopefully, given that data continues to trend positive, assuming that hold and that we have a very compelling package, we hope that we can get an approval on a faster time line than the typical PDUFA time line. But in consultation with the FDA, that was their request, hence, we didn't use the voucher.

現在就[PluvictoPSMA4]而言，我們選擇不使用優先審查憑證純粹是因為我們與 FDA 進行了討論。 FDA 的觀點是，鑑於我們將在審查期間提供 100% 的 OS，他們希望審查該數據的時間表具有靈活性。現在希望，鑑於數據繼續呈積極趨勢，假設這一情況成立並且我們有一個非常引人注目的一攬子計劃，我們希望能夠比典型的 PDUFA 時間表更快地獲得批准。但在與 FDA 協商後，這是他們的要求，因此，我們沒有使用代金券。

Matthew Weston, UBS.

馬修‧韋斯頓，瑞銀集團。

My question is about payer dynamics in 2025 as well. Vas, I'm just aware that you have a very strong position in immunology and commercial PBMs have lost a significant amount of rebates from [HUMIRA] over the course of this year. I wonder whether we should expect a particularly strong and dynamic rebate environment at the beginning of 2025, and we should be prepared for that as we look at the forecast into next year. If I can cheekily sneak a second. It's just can you remind us factually when do you anticipate Kisqali ex US patent expiry?

我的問題也與 2025 年的付款人動態有關。 Vas，我只是知道你們在免疫學領域擁有非常強大的地位，而商業 PBM 在今年已經失去了 [HUMIRA] 的大量回扣。我想知道我們是否應該在 2025 年初期待一個特別強勁且充滿活力的回扣環境，並且在我們展望明年的預測時應該為此做好準備。如果我可以厚顏無恥地偷偷溜一秒鐘。您能否實際提醒我們，您預計 Kisqali 的美國專利何時到期？

Thank you, Matthew. So first, on Cosentyx and the overall immunology dynamic. We've completed largely our payer negotiations, and we're really pleased with the broad access we've been able maintain for Cosentyx. And I would say, while we do see increased rebates, it's modest and not substantial. So we've been able to keep that as a single-digit increase overall across the portfolio. So we shouldn't expect -- well, of course, that is a headwind. We do expect overall the opportunities in HS and IV alongside the opportunities that we have in with additional launches as well as the overall momentum we have globally, that globally, Cosentyx should continue to grow in the double-digit range. And so that's our current expectations for Cosentyx.

謝謝你，馬修。首先，關於 Cosentyx 和整體免疫學動態。我們已經基本完成了付款人談判，我們對能夠為 Cosentyx 維持廣泛的訪問感到非常滿意。我想說，雖然我們確實看到回扣增​​加，但幅度不大，而且金額不大。因此，我們能夠在整個投資組合中保持個位數的成長。所以我們不應該期望──當然，這是一個逆風。我們確實預計 HS 和 IV 領域的總體機會以及我們在額外推出中所獲得的機會以及我們在全球範圍內的整體勢頭，即在全球範圍內，Cosentyx 應繼續以兩位數的速度增長。這就是我們目前對 Cosentyx 的期望。

Now in terms of Kisqali LOE, it is August 2032 is our current estimate in Europe.

現在，就 Kisqali LOE 而言，我們目前對歐洲的估計是 2032 年 8 月。

James Quigley from Goldman Sachs.

高盛的詹姆斯·奎格利。

Got a quick one on (inaudible). So Vas, you've seen some strong uptake in the US for the food allergy indication, does Novartis plan to use the data from the (inaudible) trial to potentially from the indication in the Novartis territories? And what would you think about the potential opportunity here? Obviously, there's a (inaudible) in [ligelizumab] in this indication as well. So does that be a potential clear one for you and [Zola] in ex US markets.

快速打開（聽不清楚）。 Vas，您已經看到食物過敏適應症在美國的使用率很高，諾華是否計劃將（聽不清楚）試驗的數據用於諾華地區的適應症？您如何看待這裡的潛在機會？顯然，該適應症中也有[ligelizumab]（聽不清楚）。那麼，這對您和 [Zola] 在美國以外的市場來說是一個潛在的明確的機會嗎？

Yes. So James, I have to come back to you. I don't actually know off the top of my head on what our plans are on [XOLAIR] for ex US food allergy. Obviously, in the US, we have our existing contractual obligations with [Roche Genentech]

是的。所以詹姆斯，我必須回到你身邊。我實際上根本不知道我們對 [XOLAIR] 針對前美國食物過敏有何計劃。顯然，在美國，我們與[羅氏基因泰克]有現有的合約義務

In general, my first instinct to say is if food allergy ex US is challenging given the overall payer dynamics, particularly in Europe. But let us come back to you because I don't want to make that a definitive statement without knowing for sure. We do continue to develop [remibrutinib] as an oral option in food allergy, and we're going to see how that data pans out because we think the option of giving patients the twice-a-day oral therapy for food allergy could be quite attractive. So that development program is continuing on track.

總的來說，我的第一直覺是，考慮到整體支付動態，特別是在歐洲，美國以外的食物過敏是否具有挑戰性。但讓我們回到你身上，因為我不想在不確定的情況下做出明確的聲明。我們確實繼續開發[瑞布替尼]作為食物過敏的口服選擇，我們將看看這些數據的結果如何，因為我們認為為患者提供每天兩次的口服治療食物過敏的選擇可能是相當有效的吸引人的。因此，該開發計劃正在繼續按計劃進行。

Peter Welford from Jefferies.

來自傑富瑞 (Jefferies) 的彼得·韋爾福德 (Peter Welford)。

My question is on the broader cardiovascular portfolio now at Novartis, particularly focusing on the pipeline. I mean, obviously, we're aware of (inaudible) which I wonder if you can confirm we're still expecting the Phase III readout there next year. But obviously, following the news on [XXB], when you now look at the late-stage cardiovascular portfolio outside of nephrology, I guess how do you now think about the need perhaps in Novartis to bolster that, or are you comfortable given the long life that we see still with Leqvio ahead despite the loss of interest or in the US, so you will basically just build the cardiovascular pipeline largely internally through the early stage Phase I preclinical programs that you have?

我的問題是關於諾華目前更廣泛的心血管產品組合，特別是關注管道。我的意思是，顯然，我們知道（聽不清楚）這一點，我想知道您是否可以確認我們仍然期待明年的第三階段讀數。但顯然，根據 [XXB] 的新聞，當您現在查看腎臟病學之外的後期心血管產品組合時，我想您現在如何看待諾華可能需要支持這一點，或者考慮到長期儘管失去了興趣，我們還是在美國看到了Leqvio 的未來，所以你們基本上只是透過你們擁有的早期階段一期臨床前計畫在內部建立心血管管道？

Yes. Thanks, Peter. So obviously disappointing with [XXP]. But overall, we feel confident given where we see Leqvio's continued expansion and the adjustments we've anyway made to the field force, we think we're rightsized for Leqvio. (inaudible) on track, it's event driven. So we'll have to continue to track the events, but we currently guide to a 2025 readout. And then behind that, right now, we're really focused on accelerating our [SiRNA] portfolio.

是的。謝謝，彼得。顯然對[XXP]感到失望。但總的來說，鑑於我們看到 Leqvio 的持續擴張以及我們對現場人員所做的調整，我們充滿信心，我們認為我們的規模適合 Leqvio。 （聽不清楚）步入正軌，它是事件驅動的。因此，我們必須繼續追蹤事件，但我們目前指導的是 2025 年的讀數。在那之後，我們現在真正專注於加速我們的 [SiRNA] 產品組合。

Those [siRNAs] could either be as mono indications or in combination with Leqvio, so we're exploring a range. And we have, now a couple in Phase II, or one, it's even a bit later than that. So we'll be providing updates on those over time. But certainly, [siRNAs] in hypertension [sRNAs] against [HMG COA], which could be then used in combination or independent of Leqvio as well as other earlier Phase I siRNAs are all advancing. So we continue to want to build out a broad (inaudible) portfolio and then also look as appropriate for combinations with Leqvio.

這些 [siRNA] 可以作為單一適應症，也可以與 Leqvio 組合使用，因此我們正在探索一系列範圍。我們現在有兩個處於第二階段，或一個，甚至比那晚一點。因此，我們將隨著時間的推移提供相關更新。但可以肯定的是，高血壓中的[siRNA]針對[HMG COA]的[sRNA]，然後可以與Leqvio聯合使用或獨立使用，以及其他早期I期siRNA都在進步。因此，我們仍然希望建立一個廣泛的（聽不清楚）產品組合，然後尋找與 Leqvio 的適當組合。

The other element -- 2 elements of our story, I think, on cardiovascular. One is a portfolio of agents in arrhythmia, high risk, very high risk, but we're relatively on our own in (inaudible). And so we have a few agents now in Phase I or proof-of-concept studies. So we'll certainly see how those ultimately play out. And then we have, obviously, as all companies do a broad preclinical portfolio, but including preclinical efforts on novel targets in obesity as well as in other areas of cardiovascular risk reduction, particularly around nephrology. So we'll see how those advance as well.

另一個元素——我認為我們故事的兩個元素是關於心血管的。一種是治療心律不整、高風險、非常高風險的藥物組合，但我們在這方面相對靠自己（聽不清楚）。因此，我們現在有一些藥物處於第一階段或概念驗證研究中。所以我們肯定會看到這些最終結果如何。顯然，正如所有公司一樣，我們也有廣泛的臨床前產品組合，但包括針對肥胖以及降低心血管風險的其他領域（特別是腎臟病學）新目標的臨床前努力。所以我們也會看看這些進展如何。

So obviously, we'll always look externally, but there's no urgency to plug any gaps at this point.

顯然，我們總是會向外部看，但目前並不急於填補任何空白。

Etzer Darout from BMO Capital Markets.

來自 BMO 資本市場的 Etzer Darout。

I had a question on [pelacarsen] readout next year for Lp(a). And apologies if you've commented on this in the past. Just curious, there's literature on the impact of (inaudible) on GLP-1 levels, but curious as to the reverse. And I guess, given the increasing use of GLP-1s broadly, just curious of GLP-1 use matters in the study? And if so, how you're accounting for its use in the trial?

我對明年 Lp(a) 的 [pelacarsen] 讀數有疑問。如果您過去對此發表過評論，我們深表歉意。只是好奇，有文獻介紹（聽不清楚）對 GLP-1 水準的影響，但對相反的情況感到好奇。我想，鑑於 GLP-1 的使用越來越廣泛，只是對 GLP-1 在研究中的使用問題感到好奇嗎？如果是這樣，您如何解釋它在試驗中的使用？

Yes, absolutely. So I think GLP-1s are noted have, I think, modest reductions of Lp(a). I mean the focus of this study is on patients that are much higher on the range of Lp(a). So the top quartile and the top decile, which we believe you need to have pretty substantial knockdown 70% to 90% of the (inaudible) levels. 90% plus ideally that would then enable you to have the hopeful -- hope for at least the genetically validated efficacy benefit.

是的，絕對是。因此，我認為 GLP-1 可以適度降低 Lp(a)。我的意思是，這項研究的重點是 Lp(a) 範圍高得多的患者。因此，最高四分之一和最高十分之一，我們認為您需要將（聽不清楚）水平的 70% 到 90% 相當大地擊倒。理想情況下 90% 以上，這將使您充滿希望——至少希望獲得基因驗證的功效益處。

So we don't believe GLP-1s alone or [PCSK9s] alone, PCSK9s also knocked on Lp(a), are going to be sufficient for this patient population that is at a very high risk of cardiovascular events due to their (inaudible) levels.

因此，我們不相信單獨的GLP-1 或單獨的[PCSK9s]，PCSK9s 也敲低了Lp(a)，對於這個由於其（聽不清楚）而處於心血管事件風險非常高的患者群體來說是足夠的。

In terms of (inaudible), I don't know offhand how many patients were on a GLP-1 at baseline. But with all of these trials, we always have, of course, patients who are on standard of care for their various comorbidities. And then, of course, we would do subgroup analyses based on the various patient populations. Those would not be powered, of course, and be post (inaudible), as always, we generate those 4 slots to demonstrate how different patient groups responded to the medicine. So that's what I would expect would happen in this case.

就（聽不清楚）而言，我不知道有多少患者在基線時服用 GLP-1。但在所有這些試驗中，當然，我們總是有因各種合併症而接受標準護理的患者。然後，當然，我們會根據不同的患者群體進行亞組分析。當然，這些不會被供電，並且會像往常一樣被發布（聽不清楚），我們產生這 4 個插槽來展示不同患者群體對藥物的反應。這就是我所期望的在這種情況下會發生的情況。

Kerry Holford from Berenberg.

來自貝倫貝格的凱瑞·霍爾福德。

Just going back to the theme of M&A. Given your strong balance sheet and a growing patent expiry burden, just interested to hear you talk about your appetite for more M&A in the future here. I won if you can comment specifically on your degree of interest in (inaudible) it? Just any bad with regard to your early-stage internal pipeline. But interest in potentially bolstering that externally.

回到併購的主題。鑑於您強大的資產負債表和日益增加的專利到期負擔，我只是有興趣聽您談論您未來對更多併購的興趣。如果您能具體評論一下您對（聽不清楚）它的興趣程度，我就贏了？對於您的早期內部管道來說，只是任何不好的事情。但有興趣可能從外部加強這一點。

And tied to this, I think somewhat disappointing that we should see an impairment (inaudible) onto the (inaudible) closure. So my question then is, how can investors gain confidence in your future M&A choices? Any commentary you would have there.

與此相關的是，我認為有些令人失望的是，我們應該看到（聽不清楚）關閉受到損害（聽不清楚）。那麼我的問題是，投資人如何對您未來的併購選擇充滿信心？您在那裡會有任何評論。

Yes. Thanks, Kerry. So on overall, we have, of course, adequate firepower. And as Harry mentioned, we have a balanced approach to capital allocation, invest in the business, growing dividend in Swiss Francs, ongoing share buyback with adequate capacity to continue share buybacks as deemed appropriate. And then we've been very active in the deal front, really in the sub-$1 billion asset space.

是的。謝謝，凱瑞。所以總的來說，我們當然有足夠的火力。正如哈利所提到的，我們對資本配置採取平衡的方法，投資於業務，增加瑞士法郎的股息，持續進行股票回購，並有足夠的能力在適當的情況下繼續進行股票回購。然後我們在交易方面非常活躍，實際上是在 10 億美元以下的資產領域。

I mean most of these don't hit the radar, but we've built out, I think, a pretty -- and I'll line this in a bit more detail and meet the management. But a really broad range of assets across our key therapeutic areas as well as key technology areas to fill either mechanism of action gaps or technology gaps which we think are critical for us to succeed in those 4 core TAs or in our 3 key technology platforms.

我的意思是，其中大多數都沒有引起人們的注意，但我認為我們已經建立了一個漂亮的——我將更詳細地說明這一點並與管理層會面。但我們的關鍵治療領域和關鍵技術領域擁有非常廣泛的資產，可以填補作用機制差距或技術差距，我們認為這對於我們在這 4 個核心技術援助或 3 個關鍵技術平台上取得成功至關重要。

A great example being the various deals we've done in RLT, including Mariana oncology to build out a strong actinium profile or even the deal we announced, I think, yesterday with [Montrose Therapeutics], which gives us a strong opportunity within the world of molecular glues for immunology.

一個很好的例子是我們在RLT 中完成的各種交易，包括Mariana 腫瘤學以建立強大的錒概況，甚至我認為，我們昨天宣布與[Montrose Therapeutics] 的交易，這為我們在世界範圍內提供了強大的機會用於免疫學的分子膠。

I think regarding your specific combination -- question on obesity, no change. We think GLP-1 GIP, et cetera, are well served by the current incumbents, and we expect the flood of companies from China and elsewhere to attempt to enter these spaces. And so we don't see an opportunity to really build a differentiated profile, especially given what will likely be a very intense payer rebate environment in the US as well as genericization of first-line GLP, or older GLP-1 agents over the coming years. So we don't think that's a game to play in as a fast follower -- late follower rather focus on novel assets.

我認為關於你的具體組合——關於肥胖的問題，沒有改變。我們認為 GLP-1 GIP 等在現有企業中得到了很好的服務，我們預計來自中國和其他地方的大量公司將嘗試進入這些領域。因此，我們看不到真正建立差異化形象的機會，特別是考慮到美國可能會出現非常激烈的付款人回扣環境，以及未來一線 GLP 或較舊的 GLP-1 藥物的通用化年。因此，我們認為這不適合快速追隨者玩的遊戲——後期追隨者更應該關注新穎的資產。

And I think overall, when we look at our -- I mean, our M&A track record, we've done it very carefully, and we systematically look at it. We see our overall success rate in line with the overall sector. There are companies that are worse than us. There are a few that are a little bit better than us. But of course, if you look at the GSK oncology acquisitions, if you look at (inaudible), if you look at building out a strong RLT portfolio, I expect that with [AveXis] ultimately showing the positive impact of our intrathecal readout later this year or early next year in the 2- to 18-year-old patients. Well, that will also be a strong payback.

我認為總的來說，當我們審視我們的併購記錄時，我們非常仔細，並且系統地進行了審視。我們認為我們的整體成功率與整個產業一致。有些公司比我們更糟。有幾個比我們好一點的。但當然，如果你看看GSK 腫瘤學收購，如果你看看（聽不清楚），如果你考慮建立一個強大的RLT 產品組合，我預計[AveXis] 最終會在今年晚些時候顯示出我們鞘內讀數的正面影響今年或明年初在 2 至 18 歲的患者中進行。嗯，這也將是一個強而有力的回報。

So obviously, whenever you do clinical stage deals like we did with collaborative, you will have updated clinical data. I think that's normal in this business. I would expect sophisticated investors not to read too much into one-offs, but rather look at the overall portfolio of how a company does, it executes M&A.

顯然，每當您像我們合作一樣進行臨床階段交易時，您都會獲得更新的臨床數據。我認為這在這個行業很正常。我希望精明的投資人不要過度解讀一次性事件，而是專注於一家公司如何運作、如何執行併購的整體投資組合。

Seamus Fernandez from Guggenheim Securities.

古根漢證券公司的謝莫斯·費爾南德斯。

So really just one question to follow up on business development in areas of interest. The dynamics in immunology are obviously keying up accelerating across bispecifics, long-acting assets and overall asset development. I wanted to just ask, I guess, a bit of a blended question, not to, but what the effort with [Generate] is really seeking to execute? And if there is an awareness or when we might have the targets potentially disclosed in that collaboration? And how you're thinking about immunology writ large from a BD perspective simply because we know that Generate is also doing quite a bit there along those lines?

因此，這其實只是一個跟進感興趣領域業務發展的問題。免疫學領域的動態顯然正在加速雙特異性藥物、長效資產和整體資產開發。我想只是想問一個有點複雜的問題，而不是問，但是 [Generate] 的努力真正尋求執行什麼？如果有意識或我們什麼時候可能會在該合作中披露潛在的目標？您如何從 BD 的角度來思考免疫學，僅僅因為我們知道 Generate 在這些方面也做了很多工作？

Yes. Thanks, Seamus. So I'll divide my commentary into first AI and then separately into specific immunology.

是的。謝謝，西莫。因此，我將首先將我的評論分為人工智慧，然後單獨討論特定免疫學。

So with Novartis, our primary collaboration is with isomorphic Labs, where we partner with the noble Prize winning team there to really work on novel targets. The to generate hits and leads that we can take them further into development. So that's a collaboration that's ongoing for small molecules and potentially could expand over time into other areas of drug development.

因此，對於諾華，我們的主要合作是與 isomorphic Labs 合作，在那裡我們與那裡的傑出獲獎團隊合作，真正致力於新目標的研究。產生點擊率和潛在客戶，我們可以將它們進一步發展。因此，這是一項針對小分子正在進行的合作，並且隨著時間的推移可能會擴展到藥物開發的其他領域。

And then with Generate, we focus on biologics. We have not disclosed the targets that we're working on, but generally speaking, it would be difficult to drug targets or we want novel biologics with novel formats, as you mentioned, bispecifics, trispecifics, et cetera. So that's the focus of the GeneraBio collaboration.

然後透過Generate，我們專注於生物製劑。我們還沒有透露我們正在研究的目標，但一般來說，很難對目標進行藥物治療，或者我們想要具有新格式的新型生物製劑，正如您所提到的，雙特異性、三特異性等。這就是 GeneraBio 合作的重點。

And then we're going to learn and see how it goes as we continue to use AI to hopefully speed up our research and early development process. We could expand into additional targets with both of those collaborations over time. But I think it's early days, and I think we need to see the results of those efforts -- the first efforts and then, of course, progress step by step.

然後，我們將繼續使用人工智慧來了解並了解其進展情況，希望能夠加快我們的研究和早期開發過程。隨著時間的推移，我們可以透過這兩項合作擴展到更多目標。但我認為現在還為時過早，我認為我們需要看到這些努力的結果——首先的努力，然後當然是一步一步的進展。

I think more broadly, in immunology, in-house on top of [remibrutinib] and (inaudible), both of which will have readouts over the course of 2025, 2026, which will allow us to, I think, build two more very substantial medicines to continue to build off of the success of Cosentyx. We have a number of bispecifics and trispecific programs that are in Phase I, Phase II. And then, of course, we have (inaudible) now in either (inaudible) Phase I or Phase II development for immune (inaudible). That's our rapid CAR T therapy I think now enrolling in 6 or 7 indications, continuing to look to expand across immunology as well as in neuroscience indications.

我認為更廣泛的是，在免疫學方面，在[remibrutinib] 和（聽不清楚）之上，兩者都將在2025 年、2026 年期間進行讀數，我認為這將使我們能夠建立兩個更實質的研究藥物繼續以 Cosentyx 的成功為基礎。我們有許多雙特異性和三特異性項目處於第一階段、第二階段。然後，當然，我們現在（聽不清楚）處於（聽不清楚）免疫（聽不清楚）的第一階段或第二階段開發。我認為這就是我們的快速 CAR T 療法，現在正在招募 6 或 7 個適應症，並繼續尋求擴展到免疫學和神經科學適應症。

And so I think our BD and M&A efforts are either to bolster the areas I just mentioned bispecifics or cell therapies, or to look at novel targets like (inaudible) that we recently have done. Those are the things I think we're broadly looking at. But I would say we do believe you need to move now into more specialty immunology, more targeted immunology going into the mass market with a number of biosimilars coming out at the end of the decade. And high rebate pressure, you need to really find places where you can have a differentiated offering in the United States, particularly given that payer dynamic.

因此，我認為我們的業務發展和併購工作要么是為了支持我剛才提到的雙特異性藥物或細胞療法領域，要么是為了尋找新的目標，例如我們最近所做的（聽不清楚）。我認為這些是我們正在廣泛關注的事情。但我想說的是，我們確實相信您現在需要進入更專業的免疫學領域，更有針對性的免疫學進入大眾市場，並在本世紀末推出許多生物相似藥。由於回扣壓力很大，您需要真正找到可以在美國提供差異化產品的地方，特別是考慮到付款人的動態。

Rajesh Kumar from HSBC.

來自匯豐銀行的拉傑什·庫馬爾。

On capital allocation, can you help us understand how you think between your choice of doing deals versus buying back shares? And then what share price of multiples would doing a deal would become the only good use of capital? Then -- your share price has been quite strong if we leave today aside, but if we look at the earnings momentum, et cetera, at what point would you stop share buybacks and deploy more capital towards steelmaking?

在資本配置方面，您能否幫助我們了解您在選擇進行交易和回購股票之間有何想法？那麼，以多少倍的股價進行交易將成為資本的唯一良好利用？那麼，如果我們把今天放在一邊，你們的股價已經相當強勁，但如果我們看看盈利勢頭等，你們會在什麼時候停止股票回購並將更多資金投入鋼鐵生產？

Yes. Thanks, Rajesh. I'll give that to Harry. Harry?

是的。謝謝，拉傑什。我會把它交給哈利。哈利？

Yes. Thank you, Vas. Thank you, Rajesh. I think it's, of course, a question that has just never had an absolute answer, right? Obviously, we believe that our share price has much more potential. If I just look at our 5-year growth rate outlook (inaudible) even consensus is not there yet at the [5%], slowly creeping up every few months. No, I think consensus just made it makes it to [4%]. Of course, we keep that dynamically.

是的。謝謝你，瓦斯。謝謝你，拉傑什。當然，我認為這是一個從來沒有絕對答案的問題，對嗎？顯然，我們相信我們的股價具有更大的潛力。如果我只看一下我們的 5 年成長率前景（聽不清楚），甚至還沒有達成 [5%] 的共識，每隔幾個月就會緩慢上升。不，我認為共識剛剛達成[4%]。當然，我們會動態地保持這一點。

In terms of balance sheet and cash flow, if you we call it firepower, so nicely, right? But anyway, we have such a nice capacity that we have the situation. We can do all M&A bolt-on deals that we come up with. And by the way, it's not so easy to cut up with good ones, right, given the premiums one has to pay and the high conviction we have to have to have a great deal for our shareholders, also in terms of returns.

就資產負債表和現金流而言，如果我們稱之為火力，那就太好了，對吧？但無論如何，我們有這麼好的能力，所以我們有這樣的情況。我們可以完成我們提出的所有併購附加交易。順便說一句，考慮到必須支付的溢價以及我們必須為股東提供豐厚回報的堅定信念，要與好的公司割裂並不是那麼容易，在回報方面也是如此。

And -- but we can do both. We can do bolt-on M&A, right? Our net debt is even below one time EBITDA at the moment with $16 billion, right, EBITDA is higher, $18 million, $19 billion, [accruing] And so we have that luxury situation. On the one hand, we keep doing, I would say, continuous good share buyback at an attractive level.

而且——但我們可以兩者兼得。我們可以進行補強併購，對吧？目前我們的淨債務甚至低於 EBITDA 的一倍，為 160 億美元，對吧，EBITDA 更高，1800 萬美元，190 億美元，[應計]所以我們有這種奢侈的情況。一方面，我想說，我們繼續以有吸引力的水平持續進行良好的股票回購。

As you may know, Switzerland has an interesting situation. I think it's unique in the world that we can only do over time, right, roughly $10 billion a year max. And on the other hand, do all the bolt-on M&A to continue to further strengthen our (inaudible) pipeline. And again, obviously, we believe that our share price has significant upside potential. And that's why we continue to do both for the foreseeable future. Thank you.

如您所知，瑞士的情況很有趣。我認為這在世界上是獨一無二的，我們只能隨著時間的推移才能做到，對吧，每年最多大約 100 億美元。另一方面，進行所有補充性併購，以繼續進一步加強我們的（聽不清楚）管道。顯然，我們再次相信我們的股價具有巨大的上漲潛力。這就是為什麼我們在可預見的未來繼續這樣做。謝謝。

Steve Scala from Cowen.

來自考恩的史蒂夫·斯卡拉。

No generics of Entresto and [Promacta] were already assumed in the 2024 guidance. So (inaudible) is the only update what amount of the guidance raise is attributable to no generics of [Tasigna] And it sounds like the extension to 2025 for all three is due to litigation for [Tasigna] and Promacta in addition to Entresto and not slower generic progress and/or settlement, is that correct?

2024 年指引中尚未假定 Entresto 和 [Promacta] 為仿製藥。因此（聽不清楚）是唯一的更新，指導籌集的金額可歸因於[Tasigna] 的非仿製藥，聽起來這三者的延期到2025 年是由於[Tasigna] 和Promacta 以及Entresto 的訴訟，而不是由於訴訟較慢的一般進度和/或結算，是正確的嗎？

Yes, Steve, I can take the second part, and I'll give it to Harry on the contribution of Tasigna to the overperformance on -- overall, I mean, we're not going to comment on specific legal cases. But I think it's a combination of our litigation our settlements and our kind of competitive intelligence as to where various players are in their approvals that gives us the our current forecasting estimate of middle of next year, but that's not a definitive date. It's really going to depend on a number of factors.

是的，史蒂夫，我可以接受第二部分，我將把塔西尼亞對超額表現的貢獻交給哈利——總的來說，我的意思是，我們不會對具體的法律案件發表評論。但我認為，我們的訴訟、和解以及我們對不同參與者的批准情況的競爭情報相結合，為我們提供了目前對明年中期的預測，但這不是一個確定的日期。這實際上取決於很多因素。

As you know, we have 3 litigations ongoing with respect to Entresto, with respect to the approval with FDA, the combination patent, where we're appealing the decision in the first instance hearings on the [cocrystal] patents. So that's all unfolding. And then Promacta and Tasigna is not something we've disclosed, but we continue to estimate a mid-2025, and we'll see how the actual market develops.

如您所知，我們正在進行 3 項關於 Entresto 的訴訟，涉及 FDA 批准的組合專利，我們正在對 [共晶體] 專利一審聽證會上的決定提出上訴。這一切都在展開。然後 Promacta 和 Tasigna 不是我們所揭露的，但我們繼續估計 2025 年中期，我們將看看實際市場如何發展。

Harry, in terms of the Tasigna contribution?

哈利，就塔西納的貢獻而言？

Yes. Thank you. Yes, Steve, still have some contribution. I mean also on the Q2 call, I mentioned that if there is no generic entry, likely we will be at the higher end of our guidance. And that's what has happened now, right? So we don't expect any generic (inaudible) still. We have a bit of (inaudible). There is a small entry in the US, but it's only in one account, 10% of business. So has very little in terms of impact model this year for (inaudible)

是的。謝謝。是的，史蒂夫，還是有一些貢獻的。我的意思是，在第二季的電話會議上，我提到，如果沒有通用條目，我們可能會處於指導的較高端。這就是現在發生的事情，對嗎？所以我們仍然不期望有任何通用的（聽不清楚）。我們有一點（聽不清楚）。美國有一個小條目，但只在一個帳戶中，佔業務的10%。因此，今年的影響模型很少（聽不清楚）

But -- so there is a contribution of (inaudible) to it. We also have some close to net favorability in quarter 3, prior I guided to high single digits. Now we came in at 10%. So there was a contribution that was basically offsetting prior year favorability at one timers.

但是——所以對此有（聽不清楚）的貢獻。在我指導為高個位數之前，我們在第三季也有一些接近淨的好感度。現在我們的比例是 10%。因此，有一項貢獻基本上一次性抵消了去年的好感度。

But overall, if you look at our business, our model at the moment is like we have a 14%, 14% volume growth. Then we have 2 points of generic impact and 1 point of negative pricing, adding up to the 11% year-to-date net sales growth, right? And that's the model we go into operationally into Q4 as well into next year. And then what is expected to happen with the generic component goes a bit up and then a bit of pricing, not too much, but also partly or fully offset by some volume impact the US

但總的來說，如果你看看我們的業務，我們目前的模型是我們的銷量成長了 14%、14%。那麼我們有 2 個點的一般影響和 1 個點的負定價，加起來今年迄今為止的淨銷售額增長了 11%，對吧？這就是我們在第四季以及明年投入營運的模型。然後，通用組件的預期會上漲一點，然後價格會上漲一點，不是太多，但也部分或完全被美國的一些銷售影響所抵消

So overall, some slight contribution to getting to the high end, but overall, what we just see at the moment is a fantastic continued very good business momentum. And the only dynamic next year is really when are these generic impacts happening. But the underlying growth of the portfolio is really excellent. And that's why we are also very confident in our 5% plus CAGR for '23 to '28.

總體而言，這對達到高端市場做出了一些微小的貢獻，但總體而言，我們目前看到的是持續良好的業務動能。明年唯一的動態是這些一般影響何時發生。但投資組合的潛在成長確實非常出色。這就是為什麼我們對 23 年至 28 年 5% 以上的複合年增長率也非常有信心。

Great. Thank you, Harry. I think we have a few more questions. So operator will continue down the line.

偉大的。謝謝你，哈利。我想我們還有幾個問題。所以運營商將繼續下去。

Emmanuel Papadakis from Deutsche Bank.

德意志銀行的伊曼紐·帕帕達基斯。

I'm trying my luck and squeezing 1.5. The half is a follow- on collaborative, just to understand what has changed versus a Harry noted your high conviction at the time of completing that transaction.

我正在試試我的運氣並擠壓1.5。一半是後續合作，只是為了了解與哈利在完成交易時的高度信念相比發生了什麼變化。

And the one is on Kisqali, if I may, next year. It looks like it's going to be a particularly important to offset some of the potential headwinds you may face. Could you just talk about the realism of consensus or conservatism of consensus expectations of [$4 billion] -- is it realistic to expect you to add another $1 billion of sales? And are you expecting a gradual increase in pace of prescription adoption or some inflection both [NCCN], et cetera?

如果可以的話，明年將在基斯卡利進行。看起來抵消您可能面臨的一些潛在阻力將變得尤為重要。您能否談談共識預期的現實性或共識預期的保守性（40 億美元）——期望您再增加 10 億美元的銷售額是否現實？您是否預期處方採用的速度會逐漸加快，或 [NCCN] 等會有所變化？

Yes. Thanks, Emmanuel. On collaborative, it's nothing new. I think the data was presented in ESMO in other settings. This is a medicine that had a safety imbalance that (inaudible) has to get fully resolved prior to being able to use the data for any kind of filing.

是的。謝謝，伊曼紐。說到協作，這並不是什麼新鮮事。我認為 ESMO 中的數據是在其他設定中呈現的。這是一種存在安全性不平衡的藥物，必須先完全解決該問題（聽不清楚），然後才能將資料用於任何類型的備案。

We need to follow these patients longer to see how the two arms perform. There is an indication that OS is going in a positive direction. However, early, we need to think see this unfold, I think, for a longer period of time. And also determine what additional trials will be required given that safety signal to have a positive benefit risk. So that's what we're monitoring and we'll continue to monitor these things, I think, happened in clinical development that safety signals emerge and then you have to deal with them. So that's, I think, normal course of business in our industry.

我們需要更長時間地追蹤這些患者，看看這兩隻手臂的表現如何。有跡象表明操作系統正在朝著積極的方向發展。然而，我認為，在早期，我們需要考慮在更長的時間內看到這種情況的展開。考慮到安全訊號具有積極的效益風險，還需要確定需要進行哪些額外的試驗。這就是我們正在監測的，我認為，我們將繼續監測臨床開發中發生的這些事情，出現安全訊號，然後你必須處理它們。我認為這是我們行業的正常業務流程。

With respect to Kisqali, I don't think we're prepared here to give additional peak sales guidance, but we will update our peak sales guidance for Kisqali, given I meet the management. I think it's pretty clear you can all annualize right now the metastatic indication and where that's heading. So that already, I think, is really strong momentum in that area. And then now that we have the broad label, including those negative patients as well as the NCCN guidelines and no negative patients as well as a positive overall label at CHMP. I think we clearly are very optimistic for the overall size of this medicine, and we'll provide that update at Meet the Management.

關於 Kisqali，我認為我們不准備在這裡提供額外的高峰銷售指導，但考慮到我會見管理層，我們將更新 Kisqali 的峰值銷售指導。我認為很明顯，你們現在都可以對轉移跡象及其發展方向進行年度化。因此，我認為該領域的勢頭確實強勁。現在我們有了廣泛的標籤，包括陰性患者和 NCCN 指南，以及無陰性患者和 CHMP 的陽性總體標籤。我認為我們顯然對這種藥物的整體規模非常樂觀，我們將在與管理層會面時提供最新資訊。

I think one more -- three more. Next question, operator.

我想還有一個──還有三個。下一個問題，操作員。

Your next question comes from Richard Vosser from JPMorgan.

您的下一個問題來自摩根大通的理查德·沃瑟。

Just one on Kesimpta. Just a competitor is rolling out their subcutaneous formulation. Just thoughts on how that's impacting you see any impact at the moment?

凱辛普塔 (Kesimpta) 上只有一處。只有一個競爭對手正在推出他們的皮下製劑。只是想一下這對您有何影響，目前您認為有什麼影響嗎？

Yes. Thanks, Richard. So we haven't seen, in our experience, impacts today. We see a steady overall share slightly increased NBRx share. Our focus right now is to capture more of the growth of the B-cell class as it's been our real focus as the B-cell (inaudible) continues to grow 60% plus to hopefully, a greater and greater proportion of first line for switch for MS patients.

是的。謝謝，理查。因此，根據我們的經驗，我們今天還沒有看到影響。我們看到整體份額穩定，NBRx 份額略有增加。我們現在的重點是捕捉 B 細胞類別的更多增長，因為這是我們真正關注的焦點，因為 B 細胞（聽不清楚）繼續增長 60% 以上，希望一線轉換的比例越來越大對於多發性硬化症患者。

Most of the impact that we hear about is primarily to the competitor product within the within the IV class of these medicines. I think given the fact that there is a required for a health care professional that you need the various pretreatments and post-dose monitoring and then you have a pump involved with the subcu administration. It's not viewed as comparable to the experience of having Kesimpta, which takes seconds or minutes to inject and is relatively straight forward at-home administration for patients. So we haven't seen that impact to date.

我們聽到的大部分影響主要是針對這些藥物 IV 類的競爭對手產品。我認為，考慮到醫療保健專業人員需要進行各種預處理和劑量後監測，然後您需要一個參與 subcu 管理的幫浦。它被認為無法與 Kesimpta 的體驗相媲美，後者需要幾秒鐘或幾分鐘的注射時間，對於患者來說在家給藥相對簡單。所以到目前為止我們還沒有看到這種影響。

That said, we have to be really diligent and our teams are fully prepared to continue to argue for the value proposition.

也就是說，我們必須非常勤奮，我們的團隊已做好充分準備，繼續捍衛價值主張。

I think outside of the US, we really don't see the impact. I think there, we feel really confident that confident that given the structure of those ex US markets, there is a preference for when you can get patients out of the medical home using Kesimpta. So I think that's a continued -- allowed us to continue to have strong momentum outside the United States as well.

我認為在美國之外，我們確實沒有看到影響。我認為，我們非常有信心，考慮到美國以外市場的結構，人們優先考慮何時可以使用 Kesimpta 將患者帶出醫療之家。因此，我認為這是一個持續的過程，使我們能夠在美國以外的地區繼續保持強勁的勢頭。

Graham Parry, Bank of America.

格雷厄姆·帕里，美國銀行。

A follow-up is just on the Kisqali (inaudible) challenge from MSN just on time lines of ruling from the [Delaware] Court on that. And if MSN was actually successful in validating the patents, just your expected time lines for resolution of an appeal. And just correct me if I'm wrong, but are you sort of past the stage of settlement here? Or that would still be -- could that still be an option?

後續行動是 MSN 對 Kisqali（聽不清楚）的質疑，以及 [特拉華] 法院對此做出裁決的時間表。如果 MSN 實際上成功驗證了專利，那麼只是您預計的上訴解決時間期限。如果我錯了請糾正我，但是你已經過了解決階段了嗎？或者仍然是——這仍然是一個選擇嗎？

Yes. So no updates. (inaudible) could come at any point. So we'll continue to monitor that. We are prepared to immediately follow the necessary injunctions and appeals and that process can take, as you know, some period of time. In addition, the -- I think the -- of course, the approval has to also happen. So there's a number of things here as well. And we think we have some important elements as well to highlight with respect to that. And so I think there's -- I think we're in a good place, but we'll have to see how that really happens.

是的。所以沒有更新。 （聽不清楚）可能隨時發生。所以我們將繼續關注這一情況。我們準備立即遵循必要的禁令和上訴，正如您所知，這一過程可能需要一段時間。此外，我認為當然也必須獲得批准。所以這裡也有很多事情。我們認為在這方面我們還有一些重要的要素需要強調。所以我認為——我認為我們處於一個很好的位置，但我們必須看看這到底是如何發生的。

Difficult to say, I mean, I think without knowing exactly how the courts would time the various appeal hearings, we would say '26 and beyond. But I think we'd have to see the timing of the ruling and the appeals and the hearings to provide more granularity on that.

很難說，我的意思是，我認為在不確切知道法院如何安排各種上訴聽證會的時間的情況下，我們會說「26 及以後」。但我認為我們必須看看裁決、上訴和聽證會的時間安排，以便提供更詳細的資訊。

We will now take our final question for today. And the final question comes from the line of Matthew Weston from UBS.

我們現在將回答今天的最後一個問題。最後一個問題來自瑞銀集團的馬修‧韋斯頓。

It's a question about politics and [siRNA]. So clearly, siRNA is a mode of action is very important to Novartis. I believe you're very active in the legislation to try and get an amendment to IRA to extend the life from 9 years to 13 years in terms of government pricing action. Can you give us any update as to where that legislation is, please?

這是一個關於政治和[siRNA]的問題。很明顯，siRNA是對諾華非常重要的作用方式。我相信你們在立法中非常積極，試圖對 IRA 進行修正案，將政府定價行動的期限從 9 年延長到 13 年。您能給我們提供有關該立法的最新情況嗎？

Yes, absolutely, Matthew. So I'll take the opportunity given that nice broad question, and thank you, Matthew, for your third question today to provide, I think, a broader perspective as well.

是的，絕對是，馬修。因此，我將藉此機會提出這個很好的廣泛問題，並感謝馬修今天提出的第三個問題，我認為這也提供了更廣泛的視角。

So first, on the IRA, which, of course, is a top priority for the industry. The broader desire to, and I think important for public health and of course, pipelines in oncology, neuroscience, cardiovascular disease indication expansion to get the [9 to 13] small molecule versus large molecule aberration corrected. And there is legislation table that currently in Congress to try to get that broad correction to happen. I believe now there's bipartisan support in the house for that broad correction.

首先是 IRA，這當然是該行業的首要任務。我認為更廣泛的願望對公共衛生很重要，當然還有腫瘤學、神經科學、心血管疾病適應症擴展的管道，以糾正[9至13]小分子與大分子的畸變。國會目前有一個立法表格，試圖實現廣泛的修正。我相信現在眾議院兩黨都支持這項廣泛的修正。

Alongside that, there's a number of limited fixes that are being proposed by various factors. One of those is the [mini Act], which targets correcting for genetically targeted therapies such as siRNAs, ASOs, et cetera, and trying to get their definition more in line with what was done in [21st Century Cures]. That also has bipartisan support in the Senate and the House and a relatively low pay for. So that's also out there as well. I actually have minimal pay for, I should say.

除此之外，由於各種因素，也提出了許多有限的修復方案。其中之一是[迷你法案]，其目標是糾正基因標靶療法，例如siRNA、ASO等，並試圖使它們的定義與[21世紀治癒]中所做的更加一致。這也得到了參議院和眾議院兩黨的支持，而且薪資相對較低。所以這也存在。我應該說，我實際上的薪水是最低的。

So I think now it's much more of moving through the election period, moving through, obviously, the establishment of a new session and then trying to get those bills, whichever a combination of the various bills that are out there, there's also efforts to correct the rare disease, multiple indication for single indication situation, biosimilar definition, et cetera. And finding the right context to get those bills put in place as well as trying to get the broad mix overall for IRA. So I think all of those efforts are ongoing.

因此，我認為現在更多的是通過選舉期，顯然，透過建立新的會議，然後努力獲得這些法案，無論是現有的各種法案的組合，還是努力糾正罕見疾病、單一適應症的多種適應症情況、生物相似藥的定義等等。並找到合適的背景來落實這些法案，並努力為 IRA 提供廣泛的整體組合。所以我認為所有這些努力都正在進行中。

And a completely separate track are the various litigations that are ongoing to repeal the IRA. We have one other companies have them. The industry overall has one. So we'll see how that also plays out. I think it will be in the two- to three-year period, we get more understanding of all of those various pieces.

另一個完全獨立的軌道是正在進行的廢除 IRA 的各種訴訟。我們還有另外一家公司擁有它們。整個行業有一個。所以我們將看看結果如何。我認為在兩到三年內，我們會對所有這些不同的作品有更多的了解。

We continue to, of course, push for PBM reform in as broad way as we can and then also to get hopefully, a more sensible 340B environment, which is, I think, a significant issue for the overall industry, starting with transparency of who are the patients and what are the centers getting this money and how is it used for.

當然，我們將繼續盡可能廣泛地推動 PBM 改革，並希望獲得一個更明智的 340B 環境，我認為這對整個行業來說是一個重大問題，首先是誰的透明度患者是誰？以及如何使用。

Those are, I think, the three big priorities for us as a company and overall for the industry from a legislative standpoint as we move to a new Congress and a new President.

我認為，當我們迎來新的國會和新的總統時，從立法的角度來看，這些是我們作為一家公司和整個行業的三大優先事項。

So thank you all very, very much. I really appreciate all the great questions and interest. I hope we'll see all of you at Meet the Management in London. And in the meantime, wishing you all a very nice autumn. Take care.

非常非常感謝大家。我真的很感謝所有的好問題和興趣。我希望我們能在倫敦管理層見面會上見到大家。同時，祝大家有個美好的秋天。小心。

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。現在您可以斷開連接