Novartis AG (NVS) 2024 Q2 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q2 2024 results release conference call and live webcast. (Operator Instructions) And the conference is being recorded. (Operator Instructions)

早上好，下午好，歡迎參加諾華 2024 年第二季業績發布電話會議和網路直播。 （操作員指示）會議正在錄製中。 （操作員說明）

A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.

電話會議的錄音（包括問答環節）將在電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, operator. Good morning and good afternoon, everyone. Thank you for joining our Q2 2024 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.

謝謝你，接線生。大家早安，下午好。感謝您參加我們的 2024 年第二季財報電話會議。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。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。

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 recently were filed with and furnished to the US Securities and Exchange Commission. (Event Instructions)

有關其中一些因素的說明，請參閱該公司最近向美國證券交易委員會提交並提供的 20-F 表格以及 6-K 表格中的最新季度業績。 （活動須知）

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 thank you, everyone, for joining today's conference call. With me on the call as always is our CFO, Harry Kirsch.

謝謝斯隆，也謝謝大家參加今天的電話會議。我們的財務長 Harry Kirsch 一如既往地與我一起參加電話會議。

So starting with SliIde 4. As you saw in quarter two, we continued the strong growth performance at Novartis, which gives us conviction that we are well on track to deliver our 5% plus sales growth out to 2028 and a 40% margin target in 2027. You saw sales in the quarter were up 11% in constant currency, core operating income up 19%. Our core margin reached 39.6%, reflecting our outstanding productivity programs, but also as a consequence of our strong sales growth.

因此，從SliIde 4 開始。 40% 的利潤率目標。我們的核心利潤率達到 39.6%，反映了我們出色的生產力計劃，也是我們強勁的銷售成長的結果。

In addition, we had important innovation highlights in the quarter, which we'll review over the course of the call. But some of the really important ones included Scemblix first-line CML FDA submission, updated Kisqali NATALEE data, which we think really supports the outstanding profile of Kisqali in the adjuvant setting, in the early breast cancer setting, and we're looking forward to presenting that outstanding data at an upcoming medical congress. And continuing to build out our renal portfolio with the atrasentan submission, as well as our broader portfolio of presentations at the recent ERA meetings.

此外，我們在本季有重要的創新亮點，我們將在電話會議期間進行回顧。但一些真正重要的數據包括 Scemblix 一線 CML FDA 提交、更新的 Kisqali NATALEE 數據，我們認為這些數據確實支持了 Kisqali 在輔助治療、早期乳癌治療中的出色表現，我們期待在即將召開的醫學大會上展示這些出色的數據。並繼續透過阿曲生坦提交來建立我們的腎臟產品組合，以及我們在最近的 ERA 會議上更廣泛的演示組合。

Taken together, this allowed us to upgrade our full year 2024 core operating income guidance. Harry will go through that in more detail.

總而言之，這使我們能夠上調 2024 年全年核心營業收入指引。哈利將更詳細地討論這一點。

Now moving to slide 5. Our Q2 growth was broad-based, and we had strong contributions from multiple of our outstanding growth drivers. Importantly, Kesimpta was also a really outstanding start earlier in the year and continued that momentum. Kisqali also continued its strong momentum. Cosentyx with the recent launches, continues to grow in a robust way. We saw steady growth in Pluvicto, strong growth in Leqvio and Scemblix. And taken together a 37% constant currency growth, which we expect to continue.

現在轉到投影片 5。重要的是，Kesimpta 在今年早些時候也取得了非常出色的開局，並延續了這一勢頭。基斯卡利也持續保持強勁勢頭。隨著最近的推出，Cosentyx 繼續強勁成長。我們看到 Pluvicto 的穩定成長，Leqvio 和 Scemblix 的強勁成長。綜合來看，貨幣持續成長 37%，我們預期這種成長將持續下去。

Taking each one of these brands in turn, step by step. Entresto delivered 28% growth in quarter two, and we continue to have high confidence we will exceed our $7 billion peak sales guidance for this medicine. That growth was driven by all our core geographies. You can see here in the middle panel, US weekly TRx reached another record high. That 25% growth was fueled by consistent demand across the various segments that we compete in.

逐步地依序了解這些品牌中的每一個。 Entresto 在第二季度實現了 28% 的成長，我們仍然充滿信心，我們將超過該藥物 70 億美元的高峰銷售指引。這種成長是由我們所有核心地區推動的。您可以在中間面板中看到，美國每週 TRx 創下了另一個歷史新高。 25% 的成長是由我們參與競爭的各個細分市場的持續需求所推動的。

Outside of the US, growth was 30%, with strong contribution from China and Japan, where we continue to see momentum from Entresto in heart failure, but importantly as well, in hypertension. So we remain confident in the continued sustained performance of the medicine.

在美國以外的地區，成長了 30%，其中中國和日本做出了巨大貢獻，我們繼續看到 Entresto 在心臟衰竭方面的勢頭，但同樣重要的是在高血壓方面。因此，我們對該藥的持續表現仍然充滿信心。

For forecasting purposes, we continue to assume an Entresto LOE in mid-2025. However, we continue to enforce our patents and litigate our patents, and will ensure that we maximize this brand for as long as possible in the United States alongside EU RDD in November of 2026.

出於預測目的，我們繼續假設 Entresto LOE 出現在 2025 年中期。然而，我們將繼續執行我們的專利並提起專利訴訟，並將確保我們在 2026 年 11 月與歐盟 RDD 一起在美國盡可能長時間地最大化該品牌。

Then moving to slide 7. Cosentyx grew at 22% in the quarter, and this is fueled by our new launches. And I think importantly, if you take a step back, puts us well on our trajectory to reach $7 billion plus of our peak sales for Cosentyx. When you look at the demand growth by geography, the US grew 34%, driven by volume.

然後轉到幻燈片 7。我認為重要的是，如果退一步，我們將順利實現 Cosentyx 銷售額高峰 70 億美元以上的目標。當您按地域查看需求成長時，您會發現，在數量的推動下，美國成長了 34%。

Ex-US, we were up 10%. And this was partially offset by onetime pricing effects due in Germany, in particular, due to the addition of additional new indication. Normal part of the German process as you get additional indications you do see price adjustments. We see Cosentyx doing very well in its core indications.

除美國外，我們上漲了 10%。這被德國的一次性定價效應所部分抵消，特別是由於增加了額外的新適應症。德國流程的正常部分，當您收到其他指示時，您確實會看到價格調整。我們看到 Cosentyx 在其核心適應症方面表現非常出色。

I think one important dynamic is the strong launch in HS is supporting us in our core indications of psoriasis, PsA, and AS. We're the number one IL-17 in the US dynamic market, the lead originator biologic in Europe and China.

我認為一個重要的動態是 HS 的強勁推出支持我們的銀屑病、銀屑病關節炎和 AS 的核心適應症。我們是美國充滿活力的市場上排名第一的 IL-17，也是歐洲和中國領先的生物製劑原廠藥。

In HS, we're seeing a very strong uptake with market leadership share of over 60% in the NBRx. In Germany, we're over 50%. And I think importantly, with the launch of Cosentyx, we're seeing increased diagnosis and desire to treat amongst physicians and patients, which I think will allow the HS market to grow to larger than its historically been. And of course, a lot of Cosentyx to help these patients achieve their treatment goals.

在 HS 領域，我們看到了非常強勁的成長，NBRx 的市場領先份額超過 60%。在德國，我們超過了 50%。我認為重要的是，隨著 Cosentyx 的推出，我們看到醫生和患者的診斷和治療意願增加，我認為這將使 HS 市場成長到比歷史上更大的規模。當然，還有大量的 Cosentyx 來幫助這些患者實現他們的治療目標。

For Cosentyx IV, we saw solid adoption with over 700 accounts now ordering. And we do expect further demand increases in the second half now that we have a permanent J-code in effect as of July 1.

對於 Cosentyx IV，我們看到了廣泛的採用，目前已有 700 多個帳戶訂購。鑑於自 7 月 1 日起永久生效的 J 代碼，我們預計下半年需求將進一步增加。

So moving to slide 8. Kesimpta also delivered, as I mentioned, a very strong quarter too, 65% growth. This was broad-based in terms of geographic growth profile. Over 100,000 patients have now been treated worldwide, naive or first switch with Kesimpta. In the US, we saw 49% growth. This demand growth was driven by TRx volume of 43% versus prior year. We gained 4% market share overall in the segment. Outside of the US, we have an NBRx leadership in 7 out of 10 major markets.

現在轉到幻燈片 8。就地理成長情況而言，這是基礎廣泛的。目前，全球已有超過 10 萬名患者接受了 Kesimpta 治療，無論是初次使用還是首次轉用 Kesimpta。在美國，我們看到了 49% 的成長。這項需求成長是由 TRx 數量較上年增加 43% 所推動的。我們在該領域的整體市佔率獲得了 4%。在美國以外，我們在十分之七的主要市場中處於 NBRx 領先地位。

So looking forward, we feel confident we will exceed our Kesimpta $4 billion guidance, peak sales guidance. We see a strong trajectory for this brand. Its profile is unique. Self-administered B-cell treatment option, one minute a month dosing, no steroid pretreatment required, an attractive safety profile with respect to injection site reactions. Persistence and adherence we're seeing in the real-world setting is comparable to infused B-cell therapies. We also continue to generate data which support the strong efficacy profile of this medicine.

因此，展望未來，我們有信心超過 Kesimpta 40 億美元的高峰銷售指引。我們看到這個品牌的強勁發展軌跡。它的外形是獨一無二的。自我管理的 B 細胞治療選項，每月一分鐘給藥，無需類固醇預處理，在註射部位反應方面具有有吸引力的安全性。我們在現實世界中看到的持久性和依從性與輸注 B 細胞療法相當。我們也持續產生支持該藥物強大功效的數據。

So moving to slide 9. Kisqali grew 50% in the metastatic setting and with now leading -- continued leading NBRx share in the US and ex-US. As you know, Kisqali has an outstanding data profile in the metastatic breast cancer setting. That's really supporting us consistently now around the world.

因此，轉到幻燈片 9。如您所知，Kisqali 在轉移性乳癌領域擁有出色的數據資料。這確實是我們在世界各地持續不斷的支持。

In the US, we saw a 67% growth, where we gained widespread adoption. We have a leading share now NBRx share of 47%. 7,000 HCPs now prescribing and that provides us a very strong base of physicians, which we can leverage as we move to the early breast cancer launch. Similarly, outside of the US, 35% growth as the preferred CDK4/6 inhibitor. We have a leading share of 38%. We're the fastest-growing CDK4/6 inhibitor in Europe.

在美國，我們看到了 67% 的成長，並獲得了廣泛的採用。目前我們的 NBRx 份額處於領先地位，為 47%。目前有 7,000 名 HCP 正在開處方，這為我們提供了非常強大的醫生基礎，我們可以在進入早期乳癌治療階段時利用這一基礎。同樣，在美國以外，作為首選 CDK4/6 抑制劑的成長率為 35%。我們的市佔率領先，達到 38%。我們是歐洲成長最快的 CDK4/6 抑制劑。

And when you look at early breast cancer setting, we're on track now for a launch in half two. We've completed the manufacturing adjustments in close collaboration with the FDA, which we outlined earlier in the year. We're now anticipating a US approval by the end of quarter three. We remain confident in a broad label based on the consistency of results that we've seen across the NATALEE population.

當你觀察早期乳癌的情況時，我們現在正計劃在兩年後推出。我們已經與 FDA 密切合作完成了生產調整，正如我們在今年早些時候概述的那樣。我們現在預計美國將在第三季末獲得批准。基於我們在 NATALEE 族群中看到的結果的一致性，我們對廣泛的標籤仍然充滿信心。

And as we announced this morning, we have now updated the NATALEE data with a median follow-up of four years. All patients have now completed their three-year course of the medicine. And we see continued clinically meaningful benefit, consistent safety profile. We believe very compelling results that will really support the launch of this medicine.

正如我們今天早上宣布的那樣，我們現在更新了 NATALEE 數據，中位數追蹤時間為四年。所有患者現已完成三年的療程。我們看到了持續的具有臨床意義的益處和一致的安全性。我們相信非常令人信服的結果將真正支持這種藥物的上市。

And so we're really excited to present that data at an upcoming medical meeting and continue to support that Kisqali will hopefully be the preferred medicine for patients with early breast cancer.

因此，我們非常高興在即將召開的醫學會議上展示這些數據，並繼續支持 Kisqali 有望成為早期乳癌患者的首選藥物。

Now moving to slide 10. So Pluvicto has demonstrated very steady growth versus prior year. Now when you take a step back on Pluvicto, we're now in a transition point where our early rapid uptake is now transitioning to a place where we need to generate demand in the next wave of centers, and then eventually have the community oncology, both for the success of Pluvicto but also for the long-term success of RLT.

現在轉到幻燈片 10。現在，當你退一步討論 Pluvicto 時，我們現在正處於一個過渡點，我們早期的快速吸收現在正在過渡到我們需要在下一波中心產生需求的地方，然後最終擁有社區腫瘤學，這不僅是為了Pluvicto的成功，也是為了RLT 的長期成功。

That said, we remain highly confident in the long-term prospects of Pluvicto to be a multibillion-dollar medicine across the various segments that we'll compete in. We do believe that once we're through this period, we will get back to robust growth, particularly driven by the PSMAfore indication and later, the HSPC and all of the metastatic indications. We had growth, as I mentioned, of 44% on the quarter.

也就是說，我們對 Pluvicto 的長期前景仍然充滿信心，它將成為我們將參與競爭的各個領域的價值數十億美元的藥物。強勁成長，特別是受到PSMAfore 適應症以及後來的HSPC 和所有轉移適應症的推動。正如我所提到的，本季我們的成長率為 44%。

Now when you look specifically at the VISION population, we estimate our market share is in the mid-30%, with 50% share in established RLT treatment sites. We see a dynamic where the sites where we're well established we could have market shares above 90%. We have another group of sites where we're working to go from 50% to 90%.

現在，當您專門關注 VISION 人群時，我們估計我們的市場份額在 30% 左右，其中在已建立的 RLT 治療地點佔有 50% 的份額。我們看到了一種動態，我們成熟的網站可以擁有 90% 以上的市場份額。我們正在努力將另一組網站的使用率從 50% 提高到 90%。

And then we have a third -- about a third of sites of the 475 treatment sites that we're operating in, where we need to now get from 10% of share of the VISION population, hopefully up over time now to 50%, 90%. And that will drive the steady growth that we expect over the course of the coming quarters.

然後我們有三分之一——大約是我們正在運作的475 個治療地點中的三分之一，我們現在需要從10% 的VISION 人群中獲得，希望隨著時間的推移，可以增加到50% ， 90%。這將推動我們預計未來幾季的穩定成長。

Now when you look specifically at what we're doing to supercharge Pluvicto and also enable us to build a broad capacity for the system to take on RLT, we're increasing our US promotional efforts, including a field force expansion, which is now completed. We'll be launching a DTC campaign in quarter three.

現在，當您具體了解我們正在做什麼來增強 Pluvicto 的性能並讓我們能夠為系統建立廣泛的能力來應對 RLT 時，我們正在加大美國的推廣力度，包括現已完成的現場人員擴充。我們將在第三季啟動 DTC 活動。

We'll also have the phased launch of the patient-ready dose, which is a very important I think step and that it reduces the time from providing Pluvicto from around an hour to less than 10 minutes. And this will allow sites to hopefully take on more patients, especially sites that have significant capacity to take on more VISION patients.

我們還將分階段推出患者即用劑量，我認為這是非常重要的一步，它將提供 Pluvicto 的時間從大約一個小時縮短到不到 10 分鐘。這將使站點有望接待更多患者，特別是那些有能力接待更多 VISION 患者的站點。

And then lastly, we had German pricing approved, which is why you've seen the uplift in the ex-US market, ex-US sales profile.

最後，我們批准了德國定價，這就是為什麼您看到美國以外市場、美國以外銷售狀況的提升。

So looking ahead, FDA submission for PSMAfore on track in half two. We already have profiled the positive trend in OS in PSMAfore. China submission is planned in the second half, and we did do a groundbreaking now for a RLT manufacturing site in China, alongside plan also for manufacturing sites in Japan. And then PSMAddition and PSMA-DC continue to progress as per plan.

因此，展望未來，FDA 提交 PSMAfore 的申請將在兩年後步入正軌。我們已經在 PSMAfore 中描述了作業系統的正面趨勢。中國計劃於下半年提交，我們現在確實在中國的 RLT 製造基地取得了破土動工，同時也計劃在日本建立製造基地。然後 PSMAddition 和 PSMA-DC 繼續按計劃進行。

So moving to slide 11. Leqvio had strong growth as well, 134% growth. I think we're seeing step by step, more and more acceptance of the option to take twice-a-year medicine to achieve 50% to 60% cholesterol lowering. and that's a trend we're seeing broad-based around the world. We have now 4,200 facilities ordering Leqvio in the US.

轉到幻燈片 11。我認為我們正在逐步看到越來越多的人接受每年服用兩次藥物以實現 50% 至 60% 膽固醇降低的選擇。這是我們在世界各地看到的廣泛趨勢。目前，我們在美國有 4,200 家工廠訂購 Leqvio。

We continue to steadily expand our breadth and depth, continue to generate additional data to support the profile of Leqvio as we move also towards our outcomes trials, two outcomes trials for Leqvio. As well as continue to progress efforts to move Leqvio into the frontline setting for cholesterol management.

我們繼續穩步擴大我們的廣度和深度，繼續產生更多數據來支持 Leqvio 的概況，同時我們也轉向我們的結果試驗，即 Leqvio 的兩項結果試驗。並繼續努力將 Leqvio 推向膽固醇管理的前線。

Outside of the US, our rollout continues with over 35 countries with reimbursement strong. Market growth, 24% versus prior year. And so we feel confident step-by-step Leqvio will also progressing towards its multibillion-dollar goal.

在美國以外，我們繼續在超過 35 個國家進行推廣，報銷力道很大。市場成長，較上年增長 24%。因此，我們有信心 Leqvio 也將逐步實現其數十億美元的目標。

Now moving to slide 12. Scemblix's momentum continued in quarter two. And I think as you're all aware, we have US market leadership in the third line setting. And most importantly, at ASCO, we presented our outstanding first-line data, which I'll go in a little bit further detail about on the next slide.

現在轉到幻燈片 12。我想你們都知道，我們在美國三線市場處於領先地位。最重要的是，在 ASCO 上，我們展示了出色的第一線數據，我將在下一張投影片中進一步詳細介紹這些數據。

Now when you look at the third-line setting, we're the market leader in NBRx and TRx share in the US Outstanding performance as well we're seeing outside of the United States. TRx and monthly prescribers continue to grow across all geographies.

現在，當您查看第三線設定時，我們在美國的 NBRx 和 TRx 份額方面處於市場領先地位，在美國以外的地區也表現出色。 TRx 和每月開處方的人數在所有地區持續增加。

One important note for modeling purposes is that in -- shortly, we'll be launching a 100-milligram SKU for the T315I patients, a patient group that requires 400 milligrams of Scemblix, which is about 10 pills per day, they will now be able to take 4 pills per day. But what that will lead to is about a $15 million sales that will not repeat in quarter two and quarter three.

出於建模目的的一個重要注意事項是，不久後，我們將為 T315I 患者推出 100 毫克 SKU，該患者組需要 400 毫克 Scemblix，即每天約 10 粒藥片，他們現在將每天可以服用4粒。但這將帶來約 1500 萬美元的銷售額，而這種情況在第二季和第三季不會重複。

So for all your modeling, just to take into account that because of that price adjusts, the 100-milligram dose being launched, because we have consistent pricing across SKUs, that adjustment just needs to be factored into your models for Scemblix.

因此，對於您的所有建模，只需考慮到由於價格調整而推出的 100 毫克劑量，因為我們對各個 SKU 的定價保持一致，因此只需將這種調整考慮到您的 Scemblix 模型中。

But more importantly, we're very confident in the first-line opportunity. We have FDA submission under real-time oncology review. We received breakthrough therapy designation. I think all of you saw the truly outstanding data at ASCO that positioned Scemblix the medicine of choice for patients in the frontline setting. And we're looking forward to also completing our ex-US submissions in 2024 and 2025.

但更重要的是，我們對一線機會非常有信心。我們已向 FDA 提交了即時腫瘤學審查報告。我們獲得了突破性治療指定。我想你們所有人都看到了 ASCO 真正出色的數據，這些數據使 Scemblix 成為第一線患者的首選藥物。我們期待在 2024 年和 2025 年完成美國以外地區的提交。

Now moving to the Scemblix ASCO data. As a reminder, this was data that demonstrated superior efficacy and a favorable safety and tolerability profile against standard of care TKIs in first-line CML. Efficacy-wise, superior MMR rates and also deep molecular response, importantly as well against all TKIs and against imatinib with very impressive differences. We had earlier achievement of MMR, greater depth of responses. Also important improvement versus second-gen TKIs in MMR speed and depth.

現在轉向 Scemblix ASCO 數據。提醒一下，這些數據證明了與第一線 CML 護理標準 TKI 相比具有卓越的療效以及良好的安全性和耐受性。就功效而言，卓越的 MMR 率和深入的分子反應，重要的是針對所有 TKI 和伊馬替尼，具有非常令人印象深刻的差異。我們較早實現了 MMR，反應深度也較深。與第二代 TKI 相比，MMR 速度和深度也有重要改進。

And then very importantly, as well for these patients, and I think from a physician standpoint as well, outstanding safety and tolerability. Fewer Grade 3 AEs, fewer dose adjustments or interruptions. Really making Scemblix, I think, from a safety profile, the medicine of choice for these patients.

然後非常重要的是，對於這些患者來說，我認為從醫生的角度來看，也有出色的安全性和耐受性。 3 級 AE 更少，劑量調整或中斷更少。我認為，從安全性角度來看，Scemblix 確實是這些患者的首選藥物。

So we're very excited about bringing this medicine forward. We guided to $3 billion-plus peak sales for Scemblix. As a reminder, Scemblix has protection into the mid-2030s. Also is not -- because as a rare disease medicine will not be part -- expected to be part of the IRA. So a really great profile. Great medicine. Very excited about its future.

因此，我們對推出這種藥物感到非常興奮。我們預計 Scemblix 的銷售額高峰將超過 30 億美元。提醒一下，Scemblix 的保護期可以持續到 2030 年代中期。也不希望成為 IRA 的一部分，因為作為一種罕見疾病藥物，不會成為其一部分。所以這是一個非常棒的個人資料。很棒的藥。對其未來非常興奮。

Now turning to Fabhalta. We had the US PNH launch, which is off to a very encouraging start. We saw really strong growth in quarter two versus quarter one. Ex-US approvals have also been received now in multiple markets.

現在轉向 Fabhalta。我們在美國推出了 PNH，這是一個非常令人鼓舞的開始。與第一季相比，我們看到第二季的成長非常強勁。目前，多個市場也已獲得美國以外的批准。

And when you look at the profile of Fabhalta, we're making steady progress. We have REMS-certified HCPs ahead of competitive benchmarks. We see continued uptake across naive and switch patients. Patients are getting treated across all hemoglobin levels, but also including those patients at 10 to 12 or just slightly below normal I think, showing the interest there is in a twice-a-day oral option. We also see increasing commercial coverage as part of our -- from our bridge program.

當您查看 Fabhalta 的資料時，您會發現我們正在穩步取得進展。我們擁有領先於競爭基準的經 REMS 認證的 HCP。我們看到初治患者和轉換患者的持續接受。患者正在接受所有血紅蛋白水平的治療，但也包括那些血紅蛋白水平為 10 至 12 或略低於正常水平的患者，這表明人們對每天兩次口服選擇的興趣。我們也看到商業覆蓋範圍不斷擴大，這是我們橋樑計劃的一部分。

So all on track with respect to Fabhalta. We would expect in the second half to now see steady growth, but also to take into account that the bolus of patients that we saw in the first half, especially the conversion from bridge, likely won't repeat in the second half. So our growth rate will be steady, and I think it's exciting, but also certainly not at the rates that we saw in the early part of the year.

就 Fabhalta 而言，一切都步入正軌。我們預計下半年會穩定成長，但也要考慮到我們在上半年看到的病患推注，尤其是從橋樑的轉換，下半年可能不會重複。因此，我們的成長率將是穩定的，我認為這令人興奮，但也肯定不會達到我們今年早些時候看到的成長率。

Now moving to slide 15. Turning to our renal portfolio, as you all know, we've been working to build an attractive portfolio to manage IgAN, C3G and related renal diseases. And as part of that effort, we acquired atrasentan.

現在轉到幻燈片 15。作為這項努力的一部分，我們獲得了阿曲生坦。

And in the Phase III ALIGN-IgAN study, we announced at ERA in May, a 36% proteinuria reduction relative to placebo. We're very excited about this medicine as we think it can be a foundational medicine to provide hemodynamic and nephroprotective potential for patients and physicians.

在 III 期 ALIGN-IgAN 研究中，我們在 5 月的 ERA 上宣布，相對於安慰劑，蛋白尿減少了 36%。我們對這種藥物感到非常興奮，因為我們認為它可以成為為患者和醫生提供血流動力學和腎臟保護潛力的基礎藥物。

It's a clinically meaningful proteinuria reduction. We see a very favorable safety profile. We think up to 50% of patients with persistent proteinuria progress to kidney failure. So important that these patients get better options. We've submitted to FDA. And of course, the study continues in a blinded fashion to 2026 when we would read out the eGFR. So looking forward to launching this medicine in 2025.

這是具有臨床意義的蛋白尿減少。我們看到了非常有利的安全狀況。我們認為高達 50% 的持續性蛋白尿患者會進展為腎衰竭。讓這些患者獲得更好的選擇非常重要。我們已經向 FDA 提交了申請。當然，這項研究會以盲目的方式持續到 2026 年，屆時我們將讀出 eGFR。所以期待2025年推出這種藥物。

Alongside that, with iptacopan, we also announced at ERA, the full result Phase III APPEAR-C3G study, which demonstrated 35% proteinuria reduction relative to placebo. You can see the design on the left-hand side of the slide.

除此之外，我們還在 ERA 上宣布了 iptacopan 的 III 期 APPEAR-C3G 研究的完整結果，該研究表明相對於安慰劑，蛋白尿減少了 35%。您可以在投影片左側看到設計。

On the right-hand side, you see that impressive minus 30% versus an increase of 7.6% in the placebo arm. We saw numerical improvements in eGFR, favorable safety profile overall. This would be the first treatment -- potential treatment targeting the complement pathway in C3G. And again, in these patients, 50% of patients develop kidney failure requiring dialysis.

在右側，您可以看到令人印象深刻的負 30%，而安慰劑組則增加了 7.6%。我們看到 eGFR 的數字改善，整體安全性良好。這將是第一種治療方法——針對 C3G 補體途徑的潛在治療方法。同樣，在這些患者中，50% 的患者出現腎衰竭，需要透析。

Now importantly, today, we're also announcing that we have end of study results for this medicine at the 12-month time point that data is consistent with the six-month data, which now allows us to move forward with the filing in the second half of 2024, with an expected launch next year. We'll present that end-of-study data at an upcoming medical meeting. But I think this is an important update for this medicine, allowing us to now have also, hopefully next year, in three separate indications.

現在重要的是，今天我們還宣布，我們在 12 個月的時間點獲得了該藥物的研究結束結果，該數據與 6 個月的數據一致，這使我們能夠繼續推進在2024 年下半年，預計明年推出。我們將在即將召開的醫學會議上展示研究結束數據。但我認為這是這種藥物的一個重要更新，使我們現在（希望明年）也能有三個不同的適應症。

I'd also note, we're also working to develop Fabhalta in atypical hemolytic uremic syndrome. We announced the start of a Phase III program in myasthenia gravis. So we're very excited, another medicine that has LOE protection well into the 2030s.

我還想指出的是，我們也致力於開發用於非典型溶血性尿毒症綜合症的 Fabhalta。我們宣布啟動重症肌無力的第三階段計畫。因此，我們非常興奮，這是另一種在 2030 年代仍具有 LOE 保護的藥物。

And then as well, primarily treating younger patients, not a medicine that's exposed to the Medicare Part D IRA. So another medicine that we have, we think that can really drive our growth well into the 2030s across a broad range of rare diseases.

此外，主要治療年輕患者，而不是接觸 Medicare Part D IRA 的藥物。因此，我們認為我們擁有的另一種藥物可以真正推動我們在 2030 年代在廣泛的罕見疾病方面的成長。

Now moving to the next slide. So in closing, before handing it over to Harry, we expect to continue our innovation momentum in half two. We had 10 positive Phase III readouts in, as you all know, in 2023. Really, this year is about filing and really making sure that we get these medicines ready to launch. But we are excited as well about the next wave of medicines.

現在轉到下一張投影片。因此，最後，在將其交給 Harry 之前，我們希望在第二季度繼續保持我們的創新動力。眾所周知，我們在 2023 年獲得了 10 個積極的 III 期讀數。但我們也對下​​一波藥物浪潮感到興奮。

One thing we did want to note is we have shifted our remibrutinib CSU filing slightly as we do need to make a few CMC adjustments. But as a reminder, remibrutinib showed biologic-like efficacy in the control of CSU, very good safety profile. So we're excited to get that medicine submitted in 2025 and then out to launch. We do, of course, also expect a steady stream of readouts as well in '25, '26, which we'll profile in upcoming meetings.

我們確實想要注意的一件事是，我們稍微改變了瑞米魯替尼 CSU 備案，因為我們確實需要進行一些 CMC 調整。但需要提醒的是，瑞米布替尼在控制 CSU 方面顯示出類似生物製劑的功效，且安全性非常好。因此，我們很高興能在 2025 年提交該藥物，然後上市。當然，我們也期望在 25 年、26 年能獲得穩定的讀數，我們將在即將舉行的會議中對此進行介紹。

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

那麼，讓我把它交給哈利。

Yeah. Thank you, Vas. Good morning, and good afternoon, everybody. I'll now walk you through, as always, through our financials of the second quarter and the first half. And my comments will always refer to growth rates in constant currencies, unless otherwise stated.

是的。謝謝你，瓦斯。大家早安，下午好。現在，我將一如既往地向您介紹我們第二季和上半年的財務狀況。除非另有說明，我的評論將始終指以固定貨幣計算的成長率。

I will also be referring to continuing operations that will be still remainder of this year, given the Sandoz spin in October last year. And as you see and have seen already, we had a very strong first half of the year and continued momentum of our quarter one start into Q2.

鑑於去年 10 月山德士的轉型，我還將提到今年剩餘時間仍將持續營運的業務。正如您所看到的和已經看到的，我們上半年的表現非常強勁，並且從第一季開始到第二季度的勢頭持續強勁。

So on slide 19. Now Q2 sales grew 11%. Core operating income was up 19%. Core EPS was $1.97, growing 21%. Free cash flow was $4.6 billion, very strong, also 40% up in US dollars. For the first half, which you see on the right side, again, the same 11% growth and core operating income up 21% as Q1. It was a bit higher than Q2, but both quarters super strong.

在投影片 19 上。核心營業收入成長 19%。核心每股收益為 1.97 美元，成長 21%。自由現金流為 46 億美元，非常強勁，以美元計算也成長了 40%。上半年，您可以在右側看到，與第一季相同，成長率為 11%，核心營業收入成長 21%。它比第二季度略高，但兩個季度都非常強勁。

And our core margin on the half year, always better look on the longer period, not only one quarter, up to 39% and up 310 basis points, demonstrating clearly our continued progress towards achieving our midterm margin guidance of 40% plus by 2027. Core EPS, $3.77, up 22% and free cash flow almost up to $7 billion, up 11%.

我們半年的核心利潤率，總是更好地看待更長的時期，而不僅僅是一個季度，高達39% 和310 個基點，清楚地表明我們在實現2027 年中期利潤率指導值40% 以上的目標上不斷取得進展。

So clearly, these numbers reflect also the full effect of our pure-play pharma company and our transformation for growth, with a very strong worldwide execution.

顯然，這些數字也反映了我們純製藥公司的全部影響以及我們的成長轉型以及非常強大的全球執行力。

So turning to slide number 20. I think most importantly, to understand that we have our continued strong underlying growth dynamics will really continue. We expect that also for the second half. Usually, we do not provide quarterly guidance, but this time, it may be helpful as you model the remainder of the year.

因此，轉向第 20 號幻燈片。我們預計下半年也是如此。通常，我們不提供季度指導，但這一次，當您對今年剩餘時間進行建模時，它可能會有所幫助。

So with respect to quarterly phasing, I want to remind you that last year, Q3, and those were -- we had a couple of one-time effects which are not super significant, but likely we see in quarter three because of these 2 points of one-time effect, more high single-digit growth, so still very strong.

因此，關於季度分階段，我想提醒您，去年第三季度，我們有一些一次性影響，這些影響並不是非常顯著，但我們可能會在第三季度看到，因為這 2 點一次性效應，更高的個位數成長，所以仍然非常強勁。

But you may remember we had a onetime revenue reduction true-up of Cosentyx in Europe. And then we also had some Sandoz inventory built up ahead of the spin I mentioned this quarter three last year, but some of you may not remember that as you cover so many companies.

但您可能還記得我們在歐洲對 Cosentyx 進行了收入削減調整。然後，在我去年第三季提到的旋轉之前，我們還建立了一些山德士庫存，但你們中的一些人可能不記得了，因為你們涵蓋了這麼多公司。

And these two items add up to 2 percentage points of sales growth. And so we would anticipate this high single-digit growth in Q3. And then, of course, there is a bit of an effect on core operating income, usually 2 to 3 times of the top-line points. But again, underlying is exactly what we have seen roughly so far.

而這兩項加起來，就帶動了銷售成長2個百分點。因此，我們預計第三季將出現高個位數成長。當然，這也會對核心營業收入產生一些影響，通常是營收點的 2 到 3 倍。但同樣，潛在的情況正是我們迄今為止大致看到的。

And then in Q4, it really depends on how the two potential generics come in, Sandostatin and Tasigna. And if they don't come in, I would expect us to be at the high end of the guidance, both for the quarter as well as for the year.

然後在第四季度，這實際上取決於兩種潛在仿製藥的出現，即善寧和塔西尼亞。如果他們不進來，我預計我們本季和全年都將處於指導的高端。

So I hope that helps you a bit with the quality phasing. And again, usually don't do this, but I think this is warranting also as we increase the guidance for the year on the bottom line. At the same time, we had this quarter three base effect last year.

所以我希望這對您在品質階段方面有所幫助。再說一次，通常不會這樣做，但我認為這也是有道理的，因為我們增加了今年的利潤指引。同時，我們去年這個季度也有三基效應。

Now moving on to slide 21 for the full-year guidance. We continue to expect sales growth to be in the high single digit to low double digit. However, the strong momentum we are seeing in the business, together with continued productivity results, gives us the confidence to upgrade our bottom-line guidance. We now expect core operating income to grow in the range of mid to high teens from prior double-digit to mid-teens.

現在轉到投影片 21，了解全年指示。我們繼續預期銷售額成長將在高個位數到低兩位數之間。然而，我們在業務中看到的強勁勢頭，加上持續的生產力成果，使我們有信心升級我們的利潤指引。我們現在預計核心營業收入將從之前的兩位數成長到中雙位數。

Now, as I mentioned before, underpinning our guidance are the assumptions that no Entresto, no Promacta generics would launch in US in 2024. To complete the full-year guidance, please note that we expect the core net financial expenses to be around several hundred million, and our core tax rate to be around 16.2%.

現在，正如我之前提到的，支撐我們指導的是 2024 年不會在美國推出 Entresto 和 Promacta 仿製藥的假設。元，我們的核心稅率約為16.2%。

On slide 22, just a little reminder that we remain committed, of course, to our shareholder-friendly capital allocation strategy to invest in the business, while also returning attractive -- capital to our shareholders in the first half of the year.

在投影片 22 上，只是提醒我們一點，當然，我們仍然致力於對股東友好的資本配置策略來投資業務，同時也在今年上半年向股東返還有吸引力的資本。

In addition to investing in our internal R&D engine, we also bought an external innovation via bolt-on M&A and BD&L deals, particularly to strengthen our pipeline in oncology as well as our RLT platform. In terms of returning capital to shareholders, we paid out $7.6 billion in dividends in the first half. And we also continue our up to $15 billion share buyback, which has approximately $10 billion left to be executed by the end of 2025.

除了投資於我們的內部研發引擎外，我們還透過補充併購和 BD&L 交易購買了外部創新，特別是為了加強我們在腫瘤學領域的管道以及 RLT 平台。在向股東返還資本方面，上半年我們支付了76億美元的股利。我們也持續進行高達 150 億美元的股票回購，到 2025 年底，還有約 100 億美元需要執行。

Now on to my final slide around currencies. As always, currencies fluctuate, and we always outline that. And in Q2, FX had a negative [2% point] impact on both net sales and core operating income on our results. And if mid-July rates would prevail for the remainder of 2024, we would expect the full-year currency impact to be negative 1 to 2 percentage points on net sales and negative 3 percentage points on core operating income.

現在開始我關於貨幣的最後一張幻燈片。像往常一樣，貨幣波動，我們總是概述這一點。在第二季度，外匯對我們業績的淨銷售額和核心營業收入產生了 [2%] 的負面影響。如果 2024 年剩餘時間持續採用 7 月中旬的利率，我們預期全年的匯率影響將導致淨銷售額下降 1 至 2 個百分點，核心營業收入下降 3 個百分點。

And as a reminder, the estimated impact of exchange rates in our results are always provided mid-month on our website.

提醒一下，我們的網站始終會在月中提供匯率對我們結果的估計影響。

Back to Vas.

回到瓦斯。

Great. Thank you, Harry. So before taking your questions, just to briefly summarize.

偉大的。謝謝你，哈利。因此，在回答您的問題之前，我先簡單總結一下。

Continued momentum in quarter two with sales up 11%, core operating margin approaching 40%. We see strong commercial execution, which I think demonstrates our ability to drive our in-market brand medicines, drive our growth brands, drive new launches, system supports our bottom line guidance raise for full year 2024.

第二季持續維持成長勢頭，銷售額成長 11%，核心營業利潤率接近 40%。我們看到了強大的商業執行力，我認為這表明我們有能力推動我們的市場品牌藥品、推動我們的成長品牌、推動新產品的上市，系統支持我們提高 2024 年全年的利潤指引。

Our pipeline continues to advance with the FDA submissions of Scemblix in the first line. Atrasentan in IgAN. Our updated data for Kisqali in early breast cancer. And we're on track to achieve our midterm guidance, 5% constant currency sales growth through 2028 CAGR, 40% core operating margin by 2027. So we think really a great quarter for the company, and we look forward to continuing to drive strong performance through the remainder of this year.

隨著第一線 Scemblix 向 FDA 提交申請，我們的管道繼續推進。 IgAN 中的阿曲生坦。我們更新了 Kisqali 在早期乳癌的數據。我們預計將實現中期指導，到2028 年複合年增長率為5%，核心營業利潤率到2027 年為40%。增長今年剩餘時間的表現。

So with that, we can open the line for questions. And as someone mentioned, please, one question per analyst and then we'll come back through the list again. Thank you.

這樣，我們就可以打開提問專線了。正如有人所提到的，請每位分析師提出一個問題，然後我們將再次瀏覽該清單。謝謝。

(Operator Instructions) Emily Field, Barclays.

（操作員說明）Emily Field，巴克萊銀行。

Thank you so much for taking my question. I just wanted to ask for a bit more context just on the NATALEE delay of the PDUFA in the United States. Can you confirm that this was very specific to the manufacturing issue and that the FDA did not ask for any additional information with regards to any of the subgroups or any additional information from the clinical trials? Thank you.

非常感謝您回答我的問題。我只是想了解更多有關美國 PDUFA 的 NATALEE 延遲的背景資訊。您能否確認這是針對生產問題的，並且 FDA 沒有要求提供有關任何亞組的任何附加資訊或來自臨床試驗的任何附加資訊？謝謝。

Yes. Thanks, Emily. So this was only related to the CMC issue. We've already initiated label discussions with the FDA. We submitted some additional data to support our provision to the CMC package. With that, we had the standard three-month extension because we have submitted that additional data. So that extends the PDUFA out by three months. We believe now we're well on track having finalized the submission of that data for an approval inside of Q3.

是的。謝謝，艾米麗。所以這僅與CMC問題有關。我們已經開始與 FDA 進行標籤討論。我們提交了一些額外的數據來支持我們對 CMC 包的規定。這樣，我們就得到了標準的三個月延期，因為我們已經提交了額外的數據。因此，PDUFA 期限延長了三個月。我們相信，現在我們已順利完成資料提交，以在第三季內獲得批准。

Next question, operator?

下一個問題，接線生？

Florent Cespedes, Bernstein.

佛羅倫特·塞斯佩德斯、伯恩斯坦。

Good afternoon. Thank you very much for taking my question. A quick question on Cosentyx. The new indication in HS, could you give us some color on how you see the HS opportunity going forward? It seems that you are gaining new patients as you have a new treatment, more potent than the existing one. But there will be also new entrants in the coming years, so some color on this HS market opportunity would be great. Thank you.

午安.非常感謝您回答我的問題。關於 Cosentyx 的一個簡單問題。 HS 的新跡象，您能否給我們一些關於您如何看待 HS 未來機會的資訊？當你有了比現有療法更有效的新療法時，你似乎正在獲得新的患者。但未來幾年也會有新的進入者，因此這個 HS 市場機會的一些色彩將是很好的。謝謝。

Yes. Thanks, Florent. As you know, historically, only anti-TNF adalimumab was the only medicine available -- biologic medicine available for these patients. And so I think the market had not grown to its full potential. I mean HS is a relatively prevalent dermatological disease.

是的。謝謝，弗洛倫特。如您所知，從歷史上看，只有抗 TNF 阿達木單抗是唯一可用的藥物，即可供這些患者使用的生物藥物。因此，我認為市場尚未充分發揮其潛力。我的意思是熱射病是一種相對流行的皮膚病。

I think the second most prevalent after psoriasis. So something that -- or a second or third most prevalent after psoriasis. So I think it's something that's really a big unmet need. So I would expect there to be a significant expansion in the market as more entrants come in. And we continue to believe that Cosentyx in HS alone will be a $1 billion medicine. So we're very optimistic on Cosentyx.

我認為是繼牛皮癬之後第二流行的疾病。因此，這是繼牛皮癬之後第二或第三流行的疾病。所以我認為這確實是一個巨大的未滿足的需求。因此，我預計隨著更多進入者的加入，市場將出現顯著擴張。所以我們對 Cosentyx 非常樂觀。

Outlook in HS, even with other entrants coming in, simply because there is so much unmet need, most patients are not on biologics or many of these patients have dropped out of the system and are not receiving care at all. Now that physicians know that there are safe options available, we believe more and more patients were brought in. We see that broad-based globally.

HS 的前景，即使有其他進入者加入，僅僅是因為有太多未滿足的需求，大多數患者沒有服用生物製劑，或者其中許多患者已經退出系統並且根本沒有接受護理。既然醫生知道有安全的選擇，我們相信越來越多的患者被引入。

So as I mentioned as well, we see strong HS uptick for Cosentyx in the US as well as in EU and international markets. So we think it could be an attractive market in the long run. And we also have a pipeline we're developing as future agents to follow on for Cosentyx in HS. Now in Phase II studies, but over as it matures, we're excited about can we actually address HS with even higher efficacy medicines over time.

正如我所提到的，我們看到 Cosentyx 在美國以及歐盟和國際市場的 HS 強勁成長。因此，我們認為從長遠來看，這可能是一個有吸引力的市場。我們還有一個正在開發的管道，作為未來的藥物，以跟進 Cosentyx 在 HS 的發展。現在處於 II 期研究中，但隨著它的成熟，我們很高興隨著時間的推移，我們能否真正用更有效率的藥物來解決 HS。

Emmanuel Papadakis, Deutsche Bank.

伊曼紐爾‧帕帕達基斯，德意志銀行。

Thank you for taking the question. The pipeline question on ianalumab, which you pulled forward the readout in Sjogren's 2025. So just the drivers of that confidence on probability of success. And there's been a number of competitor updates in that space recently, so just perhaps you could refresh us with your thoughts on the magnitude of ESSDAI improvement. You're have been showing indeed whether you still consider that to be the right and definitive endpoint. Thank you.

感謝您提出問題。關於 ianalumab 的管道問題，您將其在 Sjogren 的 2025 年的讀數中提前。最近該領域有許多競爭對手的更新，因此也許您可以向我們介紹一下您對 ESSDAI 改進幅度的想法。您確實已經表明您是否仍然認為這是正確且明確的終點。謝謝。

Yeah. Thanks, Emmanuel. So absolutely, we saw a very fast enrollment, higher faster-than-expected enrollment for ianalumab in Sjogren's. So we have pulled forward that readout. As you know, Sjogren's, again, relatively prevalent rheumatological disease without really any great -- good treatment options. The Phase II data for ianalumab in Sjogren's, so really the first time that you could have a significant improvement in ESSDAI as well as other patient report outcomes.

是的。謝謝，伊曼紐。因此，絕對地，我們看到 Sjogren 的 ianalumab 入組速度非常快，比預期更快。所以我們提早了讀數。如您所知，乾燥病又是一種相對普遍的風濕病，但實際上沒有任何好的治療選擇。 Sjogren 的 ianalumab 的 II 期數據，這確實是您第一次在 ESSDAI 以及其他患者報告結果中獲得顯著改善。

So obviously, we won't quantitate the magnitude of ESSDAI benefit. But if we can repeat what we saw in Phase IIb, we think that would be really a compelling option. Also, a unique mechanism of action, anti-BAFF, allows you to deplete B cells in multiple compartments, which we think will be important for a disease like Sjogren's which impacts multiple different tissues.

顯然，我們不會量化 ESSDAI 收益的大小。但如果我們能夠重複我們在 IIb 階段看到的情況，我們認為這將是一個真正令人信服的選擇。此外，抗 BAFF 的獨特作用機制可讓您消除多個區室中的 B 細胞，我們認為這對於像乾燥症這樣影響多個不同組織的疾病非常重要。

I think what will be important in addition to ESSDAI is patient-reported outcomes. I mean salivary gland function, dry eye, many of these things -- these areas are what patients would like to see improve. And if we can demonstrate, in addition to the composite endpoint, PROs that show important benefits for these patients, we think this could be an exciting opportunity.

我認為除了 ESSDAI 之外，患者報告的結果也很重要。我的意思是唾液腺功能、乾眼症等等——這些都是患者希望看到改善的方面。如果我們能夠證明，除了複合終點之外，PRO 也能為這些患者帶來重要的益處，我們認為這可能是一個令人興奮的機會。

Overall, we think ianalumab is a multibillion-dollar opportunity in combination with Sjogren's. We have multiple other Phase III programs ongoing in three separate -- four separate hematological indications where we expect readouts in 2027. We also take ianalumab to other immunology indications as well. So this is an opportunity for us to really build a significant medicine. And as a reminder as well, this medicine has protection into the mid to late 2030s.

總體而言，我們認為 ianalumab 與 Sjogren 聯合用藥是一個價值數十億美元的機會。我們還有多個其他 III 期計畫正在進行，涉及三個獨立的、四個獨立的血液學適應症，我們預計將於 2027 年公佈結果。因此，這是我們真正開發一種重要藥物的機會。也要提醒大家的是，這種藥物的保護期可以持續到 2030 年代中後期。

Richard Parkes, BNP Paribas.

理查德·帕克斯，法國巴黎銀行。

Hi. Thank you for taking my question. I was going to stick on pipeline events in 2025. On pelacarsen, probably your next sort of multi-blockbuster readout. Could you just remind us what your powering assumptions are in terms of the benefit that you're looking to see in the Lp(a) HORIZON trial? And then can you talk about barriers to uptake of Lp(a) targeting agents?

你好。感謝您回答我的問題。我打算繼續關注 2025 年的管道事件。您能否提醒我們，您希望在 Lp(a) HORIZON 試驗中看到的好處是什麼？然後您能談談 Lp(a) 標靶藥物的吸收障礙嗎？

Obviously, PCSK9 uptake has been disappointing for investors partly attributed to the need for injections and costs. I'm just wondering if those barriers are going to also limit Lp(a) targeting agents or is the lack of available alternatives for patients with elevated LP(a), and I mean those barriers are less significant. So if you could just talk about that, that would be great. Thank you.

顯然，PCSK9 的採用率令投資者感到失望，部分原因是需要注資和成本。我只是想知道這些障礙是否也會限制 Lp(a) 標靶藥物，或者對於 LP(a) 升高的患者缺乏可用的替代品，我的意思是這些障礙不太重要。因此，如果您能談論這一點，那就太好了。謝謝。

Yeah. Thank you, Richard. So first, in terms of the study design, the way we designed the pelacarsen study was to look at two different levels of Lp(a).

是的。謝謝你，理查。首先，就研究設計而言，我們設計 pelacarsen 研究的方式是檢視兩個不同程度的 Lp(a)。

So first, the top quartile, at the top quartile of Lp(a) levels, and then a separate analysis still part of the primary endpoint, which allows us to take a second look at the top decile of patients in terms of their level of Lp(a). And that was based on large-scale epidemiologic studies on how risk evolves from different quartiles and deciles of patients with elevated Lp(a).

因此，首先是 Lp(a) 水平的前四分之一，然後是主要終點的單獨分析，這使我們能夠再次查看患者的 Lp(a) 水平的前十分之一。這是基於大規模流行病學研究，研究了 Lp(a) 升高的患者的不同四分位數和十分位數的風險如何演變。

So our hope is to show us both of those analysis. I mean our goal will be to show greater than 20% CVRR. But of course, we have aspirations to get even higher. And I think if we can show even higher levels, that would certainly create a lot of motivation in physicians to make sure these patients are tested.

所以我們希望向我們展示這兩種分析。我的意思是我們的目標是顯示超過 20% 的 CVRR。但當然，我們還有志向更高的目標。我認為，如果我們能夠顯示出更高的水平，那肯定會給醫生帶來很大的動力，以確保這些患者得到測​​試。

One of the things we've learned, I think, through our various cardiovascular launches is in this day and age to take more of a specialty cardiology mindset in how we think about launching these medicines. So rather than trying to do broad-based Lp(a) testing for patients across large populations, it actually looks very systematically, looking at large-scale datasets and really targeting the group's ethnicities that have the highest risk of elevated Lp(a), and try to promote high levels of testing within those patient populations.

我認為，透過各種心血管產品的推出，我們學到的一件事是，在當今時代，我們在考慮推出這些藥物時應更多地採用專業心臟病學的思維方式。因此，與其嘗試對大量人群的患者進行廣泛的 Lp(a) 測試，不如實際上看起來非常系統化，查看大規模數據集並真正針對 Lp(a) 升高風險最高的群體種族，並嘗試在這些患者群體中促進高水平的檢測。

And alongside that to target specialty groups which have a higher propensity to want to test and treat. So those are, of course, cardiovascular specialty groups. But also, when you think about interventional cardiology, I mean there are certain specialty groups we're learning, that have a higher propensity to look for these biomarkers and then treat in order to avoid the recurrence of events, also given the push towards health care quality around the world.

除此之外，也針對那些更願意接受檢測和治療的專業族群。當然，這些都是心血管專業族群。而且，當你想到介入性心臟病學時，我的意思是，我們正在學習某些專業群體，他們更傾向於尋找這些生物標誌物，然後進行治療，以避免事件再次發生，同時考慮到對健康的推動世界各地的護理品質。

So we're trying to take a very targeted approach in how we think about our Lp(a) launch. In the future as well as cardiovascular launches in general, take a more specialty mindset, which allow us to target to the right patients and the right positions with better resource allocation and hopefully drive more rapid uptake in the future.

因此，我們正在嘗試採取非常有針對性的方法來思考 Lp(a) 的發布。在未來以及心血管產品的整體推出中，採取更專業的思維方式，這使我們能夠以更好的資源分配瞄準正確的患者和正確的職位，並有望在未來推動更快速的採用。

Graham Parry, Bank of America.

格雷厄姆·帕里，美國銀行。

Okay. Thanks for taking my question. Just wanted to come back to NATALEE actually. Can you just clarify, you still think there's no manufacturing site inspection needed for the new process? I think you said in Q1, you didn't expect to see -- assume you'd actually know by now. And just again, do you remain confident that there is no outcome coming and confidence in the broad label. I know there's some discussion in the market about the node-negative patient population and whether that's approvable or not. Thank you.

好的。感謝您提出我的問題。其實只是想回到NATALEE身邊。您能否澄清一下，您仍然認為新工藝不需要進行生產現場檢查？我想你在第一季說過，你沒想到會看到──假設你現在已經知道了。再說一遍，您是否仍然相信不會有結果，並對廣泛的標籤充滿信心。我知道市場上有一些關於淋巴結陰性患者群體以及是否可以批准的討論。謝謝。

Yes. Thanks, Graham. Again, based on the label discussions that we have, we're confident in the broad label and there is no manufacturing inspection. I mean all of the changes we've made are all related to product handling. And so I think -- and some of the suppliers in the system.

是的。謝謝，格雷厄姆。同樣，根據我們對標籤的討論，我們對廣泛的標籤充滿信心，並且沒有製造檢查。我的意思是我們所做的所有改變都與產品處理有關。所以我認為 - 以及系統中的一些供應商。

So there's no inspections. This is just providing stability data, which we're always obligated to do when we make changes. Once we finish provide that stability data and have adequate stability data, the FDA takes their decision. So it's really a topic of finalizing that review of our stability data from an FDA standpoint. But we are confident in the broad label, no other inspections, and we're gearing up for launch in late Q3.

所以沒有檢查。這只是提供穩定性數據，我們在進行更改時始終有義務這樣做。一旦我們完成提供穩定性數據並擁有足夠的穩定性數據，FDA 就會做出決定。因此，這實際上是從 FDA 的角度最終確定我們的穩定性數據審查的主題。但我們對廣泛的標籤充滿信心，沒有其他檢查，我們正準備在第三季末推出。

James Quigley, Goldman Sachs.

詹姆斯‧奎格利，高盛。

Great. Thanks for taking the questions. I've got one on Pluvicto. Could you walk us through some of the competitive dynamics you're seeing in the US? I mean you mentioned some of the centers had 30% share. So what is the consideration there in terms of driving the increase in share in those centers?

偉大的。感謝您提出問題。我在 Pluvicto 上有一張。您能否向我們介紹一下您在美國看到的一些競爭動態？我的意思是你提到一些中心擁有 30% 的份額。那麼推動這些中心份額的成長是出於什麼考量呢？

And then thinking also about the community centers, where are you in terms of the development of the community centers and Pluvicto and the offering there? And when you speak to docs, physicians in those centers, how are they thinking about Pluvicto, which is relatively more complicated than the androgen receptor inhibitors, which are overall simple and seems to be launching quite strongly as well? Thank you.

然後還要考慮社區中心，您在社區中心和 Pluvicto 的發展以及那裡提供的服務方面處於什麼位置？當你與這些中心的醫生、醫生交談時，他們如何看待 Pluvicto，它比雄激素受體抑制劑相對更複雜，雄激素受體抑制劑總體上很簡單，而且似乎也很強勁地推出？謝謝。

Yeah. Thanks, James. When you look at the dynamics on Pluvicto, so we have, let's say, roughly 425 centers. In about a third of those centers we -- which were really well established, in the VISION population, we see 90% market share. So really high levels of share of the VISION patients. We have another group of centers which are still earlier on in their evolution, we see about 50% share. Our goal is to get them to 90%.

是的。謝謝，詹姆斯。當你觀察 Pluvicto 的動態時，我們大約有 425 個中心。在這些中心的大約三分之一中，我們在 VISION 群體中已經非常成熟，佔據了 90% 的市場。 VISION 患者的比例確實很高。我們還有另一組中心，它們的發展還處於早期階段，我們看到大約 50% 的份額。我們的目標是讓他們達到 90%。

The last a third of centers are much more in the community. And here, the dynamics are where we have to just do more work. A lot of it is education. So physicians understand rather than cycling through, in the case of the VISION population, cycling through chemo and perhaps doing extra rounds of chemo better to refer and have the patients receive Pluvicto given the compelling results that we saw in the VISION study.

最後三分之一的中心更多位於社區。在這裡，動態是我們必須做更多工作的地方。其中很大一部分是教育。因此，鑑於我們在VISION 研究中看到的令人信服的結果，醫生理解，就VISION 人群而言，循環化療並可能進行額外幾輪化療更好地轉介並讓患者接受Pluvicto 治療，而不是循環化療。

So in order to motivate that, we're doing a few things, as I mentioned, another field force to get out there to educate community oncology, community urology, and as well as to strengthen that referral base. Second, DTC to make sure patients understand in the community that there is this option, so rather than cycling through chemo. Earlier on, where we know the earlier patients get to Pluvicto, the better the outcome to try to motivate that.

因此，為了激勵這一點，正如我所提到的，我們正在做一些事情，派出另一支現場力量去那裡教育社區腫瘤學、社區泌尿學，並加強轉診基礎。其次，DTC 確保患者在社區中了解有這種選擇，而不是循環化療。早些時候，我們知道患者越早接受 Pluvicto，嘗試激勵的結果就越好。

And I think if we can unlock that segment over the course of the coming months, we can continue to drive Pluvicto in the VISION population to the multibillion -- or roughly $2 billion potential we think there is, and that includes globally. I would say we're seeing very robust uptake in Germany. And over time, we expect robust uptake in other European markets.

我認為，如果我們能夠在未來幾個月內解鎖該細分市場，我們就可以繼續將VISION 人口中的Pluvicto 推向數十億——或者我們認為存在的大約20 億美元的潛力，其中包括全球範圍。我想說的是，我們在德國看到了非常強勁的採用率。隨著時間的推移，我們預計其他歐洲市場也會出現強勁的成長。

Now all of that is important for the current indication, but even more important as we move to PSMAfore, where we have 3 times the patient population. And there, again, it will be really important to, over time, build up confidence in the community to be able -- outside of the medical centers, to provide radioligand therapy, not only for Pluvicto but our whole portfolio of radioligand therapies that we're currently developing.

現在，所有這些對於當前的適應症都很重要，但隨著我們轉向 PSMAfore，我們的患者人數是原來的 3 倍，這一點變得更加重要。再次強調，隨著時間的推移，建立對社區的信心，使其能夠在醫療中心之外提供放射性配體治療，不僅是為 Pluvicto，而且是我們的整個放射配體治療組合，這一點非常重要。目前正在開發中。

So we're confident we're going to get there, step by step, but it will take time. I think things like the patient-ready dose will help. I think also enabling -- we have a whole team that enables centers to be able to deploy radioligand therapy in their clinics, which will allow them to hopefully not have to refer out, but actually provide RLT even within their centers in their own establishments, which also will be, I think, really, really attractive. So it's all on track in our view, to build this into a major opportunity.

因此，我們有信心一步一步實現這一目標，但這需要時間。我認為諸如患者準備劑量之類的事情會有所幫助。我認為我們還有一個完整的團隊，使中心能夠在他們的診所部署放射性配體治療，這將使他們希望不必轉診，但實際上甚至在他們自己的機構內的中心內提供 RLT，我認為這也將非常非常有吸引力。因此，我們認為一切都在按計劃進行，並將其轉變為一個重大機會。

And I would also want to take a moment to reflect that, in RLT, we have a number of things still continuing to develop. We are working on Lutathera in small cell lung cancer, NGB, glioblastoma, both of those are in Phase IIb studies. In addition, we have the clinical stage programs with anti-integrin, anti-Bombesin, and anti-SAP.

我還想花點時間反思一下，在 RLT 中，我們還有許多事情仍在繼續發展中。我們正在研究 Lutathera 在小細胞肺癌、NGB、膠質母細胞瘤中的應用，這兩種腫瘤都處於 IIb 期研究中。此外，我們還有抗整合素、抗Bombesin、抗SAP等臨床階段計畫。

We're advancing now into a clinic, a program we're very excited about, a HER2 RLT, where we hope to be able to demonstrate that RLT can provide a compelling safety profile versus current HER2 ADCs. And as well, now with the recent acquisition of Mariana Oncology moving rapidly to the clinic, additional RLT programs. Some of which is taking on ADC targets that are established. Some of them taking novel targets, which we think could only be used using RLT.

我們現在正在進入一個診所，這是一個我們非常興奮的項目，HER2 RLT，我們希望能夠證明 RLT 可以提供與目前 HER2 ADC 相比令人信服的安全性。此外，隨著最近收購的 Mariana Oncology 迅速進入臨床，更多的 RLT 計畫也隨之而來。其中一些正在實現 ADC 既定目標。其中一些採用新目標，我們認為這些目標只能透過 RLT 來使用。

So that's the level of confidence and investment we have in RLT for the long run, and we look forward now to getting out into the community and over time, establishing this as something that's part of routine cancer care in the US and around the world.

因此，從長遠來看，這就是我們對 RLT 的信心和投資水平，我們現在期待著進入社區，並隨著時間的推移，將其確立為美國和世界各地常規癌症護理的一部分。

Mark Purcell, Morgan Stanley.

馬克‧珀塞爾，摩根士丹利。

Yeah. Thank you very much for taking my question. First of all, the revenue aspiration is for mid-single-digit growth out to 2030, and now on a 2024 basis, about $66 billion. And when we look at consensus, it's about $53 billion at the moment before the results that were very strong today, so about a $13 billion gap.

是的。非常感謝您回答我的問題。首先，收入期望是到 2030 年實現中個位數成長，現在以 2024 年為基礎，約為 660 億美元。當我們查看共識時，在今天的結果非常強勁之前，目前的共識約為 530 億美元，因此差距約為 130 億美元。

So which growth drivers, in your opinion, does consensus underappreciate? And what are the key readouts and progress points that we should look out for, which should close the disconnect between expectations and your aspirations?

那麼，在您看來，哪些成長動力被共識低估了呢？我們應該關注哪些關鍵讀數和進展點，以消除期望與願望之間的脫節？

Yes. Thanks, Mark. So obviously, it's often the case that our aspirations are ahead of consensus. The first thing I'd say is if you look back in 2017, what we said, we delivered (technical difficulty) basis. we were a $35 billion innovation -- innovative medicines company. And this year, we'll approach a $50 billion innovative medicines company. So I think we generally have delivered against what we said we were going to do.

是的。謝謝，馬克。顯然，我們的願望常常領先於共識。我要說的第一件事是，如果你回顧 2017 年，我們所說的，我們交付了（技術難度）基礎。我們是一家價值 350 億美元的創新藥物公司。今年，我們將接觸一家價值 500 億美元的創新藥物公司。所以我認為我們總體上已經兌現了我們所說的要做的事情。

So when you look at the consensus, as you get further out, and as you know, there are fewer and fewer analysts as you get further into the future, there are a few brands that I think are high in our mind. I mean, of course, Kisqali, Pluvicto, Leqvio, iptacopan, all we believe we can drive higher than currently what's out there within the consensus figures. And depending on the brand, there's a different amount of variability.

因此，當你審視共識時，隨著你走得更遠，正如你所知，隨著你走得更遠，分析師的數量越來越少，我認為有一些品牌在我們心目中佔有很高的地位。當然，我的意思是 Kisqali、Pluvicto、Leqvio、iptacopan，我們相信我們可以推動比目前共識數字更高的水平。根據品牌的不同，有不同程度的差異。

Certainly, Scemblix with $3 billion-plus potential. But also, with the fact that historically, imatinib achieved $4.4 billion globally. We still think there's an opportunity for that medicine's full potential to be appreciated, let's say. And then when you look at remibrutinib, you look at VAY, you also have here medicines that are in late-stage development that will be launching relatively soon, that we think have the potential to also close a significant portion of the gap.

當然，Scemblix 具有超過 30 億美元的潛力。而且，從歷史上看，伊馬替尼在全球的銷售額為 44 億美元。可以說，我們仍然認為該藥物的全部潛力有機會充分發揮。然後，當您查看瑞米布替尼時，您會看到 VAY，這裡還有處於後期開發階段的藥物，這些藥物將很快推出，我們認為這些藥物也有可能縮小很大一部分差距。

So that alone, those -- that portfolio of medicines, all of which have a pretty long time line ahead of them, I think can really help us, hopefully over time, close that gap in the early 2030s. But I think then what is really on us now is to show that the next wave of medicines that we have coming that are going to be compelling.

因此，我認為這些藥物組合，所有這些都有相當長的時間線，可以真正幫助我們，希望隨著時間的推移，在 2030 年代初期縮小這一差距。但我認為我們現在真正要做的是表明我們即將推出的下一波藥物將具有吸引力。

So of course, medicines like pelacarsen, which we've already discussed on the call. We have novel hypertension and heart failure agent XXB that we'll be reading out relatively shortly in hypertension and soon in heart failure. As I mentioned, a very broad portfolio of RLT's in cancer. And if any one of those were to hit, that could be a very significant medicine. So we're very uniquely positioned there given the scale of size and our ability to do both Actinium and Lutetium.

當然，還有像 pelacarsen 這樣的藥物，我們已經在電話會議中討論過。我們有新型高血壓和心臟衰竭藥物 XXB，我們將在相對較短的時間內宣讀其治療高血壓的藥物，很快就會宣讀治療心臟衰竭的藥物。正如我所提到的，RLT 在癌症領域的應用非常廣泛。如果其中任何一個起作用，那可能是一種非常重要的藥物。因此，考慮到我們的規模以及我們生產錒和镥的能力，我們在那裡的地位非常獨特。

Taken upon that, we're also not yet in numbers, which is understandable. We continue to have conviction around immune reset. We think between YTD and some of our other programs in immunology, this is a large multibillion-dollar opportunity, which is also difficult for competitors to come into given the scale that we and only a few other competitors have within cell therapy. And then lastly, we have obviously emerging assets within the siRNA space as well, that we're hoping to provide updates on in the coming period.

考慮到這一點，我們還沒有達到數字，這是可以理解的。我們仍然對免疫重置抱持信心。我們認為，從年初至今與我們在免疫學方面的一些其他項目相比，這是一個價值數十億美元的巨大機會，考慮到我們和其他少數競爭對手在細胞治療領域的規模，競爭對手也很難進入。最後，我們在 siRNA 領域也擁有明顯的新興資產，我們希望在未來一段時間內提供更新。

So a combination of existing assets you all have seen, know and we'll provide more and more data and provide, as you see with our performance today, conviction that they have higher peak sales potential. Second is assets that we hope will read out and get approved in the next few years with significant multibillion dollar potential, and then a very broad early-stage pipeline in our core therapeutic areas, in our core technology areas, which I think, again, will prove out over time.

因此，結合你們都已經看到、了解的現有資產，我們將提供越來越多的數據，並讓你們相信它們具有更高的峰值銷售潛力，正如你們今天看到的那樣。其次是我們希望在未來幾年內獲得批准的具有數十億美元潛力的資產，然後是我們的核心治療領域和核心技術領域的非常廣泛的早期管道，我再次認為，隨著時間的推移將會得到證明。

We look forward to the challenge, but we're very confident that we'll be able to deliver against the goals we set out as we've done over the last seven years.

我們期待著挑戰，但我們非常有信心能夠實現我們在過去七年中所設定的目標。

Richard Vosser, JPMorgan.

理查沃瑟，摩根大通。

Hi, thanks for taking my question. Maybe a question on pelabresib. Could you probably give us an update on your thinking and around the filing? What extra data do you need to file with the product? And what sort of conversations are you having with the regulators around that one? Thanks very much.

您好，感謝您提出我的問題。也許是關於 pelabresib 的問題。您能否向我們介紹一下您的想法和申請的最新情況？您需要與產品一起歸檔哪些額外資料？您與監管機構圍繞這一問題進行了哪些對話？非常感謝。

Yes. Thanks, Richard. So we're still in the midst of completing the acquisition under German takeover laws. So I think there's limited things I can say at this point. But what I can say is we are awaiting 48-week follow-up data, which I think will give us a stronger sense of the overall profile of pelabresib.

是的。謝謝，理查。因此，我們仍在根據德國收購法完成收購。所以我認為目前我能說的事情很有限。但我可以說的是，我們正在等待 48 週的追蹤數據，我認為這將使我們對 pelabresib 的整體概況有更強烈的了解。

We've had good discussions with both the EU and the FDA to get that data. We'll have a better understanding of what will be required in each geography, so ultimately, bring the medicine forward for patients with myelofibrosis. So we remain excited about it. But I think we still need to get the data to finalize the exact filing plans that we have in the different geographies.

我們與歐盟和 FDA 進行了良好的討論以獲得這些數據。我們將更了解每個地區的需求，因此最終為骨髓纖維化患者提供藥物。所以我們對此仍然感到興奮。但我認為我們仍然需要獲取數據來最終確定我們在不同地區的確切申請計劃。

Alongside that, the EZH1/2 inhibitor, we also acquired in the deal, is something we're rapidly assessing. Given its profile, potential best-in-class profile to take forward in prostate cancer, potentially in other cancers, so that's something we're -- as we now go through the process of finalizing the acquisition, also to take that EZH1/2. That would, of course, help us to round out our overall portfolio in prostate. We have Pluvicto. We have follow-on actinium agents.

除此之外，我們還在交易中獲得的 EZH1/2 抑制劑是我們正在快速評估的東西。考慮到它的概況，在前列腺癌和其他癌症方面可能具有同類最佳的概況，所以這就是我們現在正在完成的收購過程，同時也將 EZH1/2 納入考慮範圍。當然，這將幫助我們完善前列腺領域的整體投資組合。我們有普盧維克托。我們有後續的錒劑。

We recently did a deal with Arvinas for an AR degrader. And then to add on a novel agent like an EZH1/2 could help us, I think, really ensure that we have leadership or amongst the leaders in prostate cancer for the long run.

我們最近與 Arvinas 就 AR 降級器達成了協議。然後添加像 EZH1/2 這樣的新型藥物可以幫助我們，我認為，真正確保我們在前列腺癌領域長期處於領先地位或處於領先地位。

Peter Welford, Jefferies. Please go ahead.

彼得‧韋爾福德，傑弗里斯。請繼續。

Hi, thanks for taking my question. I want to just return to Pluvicto, if I can, please. Just to understand you talked about some of the barriers in terms of gaining share in some of the sites. But I'm curious, just with regards to the referral pathway and what you're seeing there.

您好，感謝您提出我的問題。如果可以的話，我想回到普盧維克托。只是為了了解您談到了在某些網站上獲得份額方面的一些障礙。但我很好奇，只是關於推薦途徑以及您在那裡看到的內容。

Because I guess if you're starting DTC, it would suggest that you've got a high degree of confidence in some of the patients, particularly in the community, can then get to specialist centers for the VISION indication. I guess maybe you can talk a little bit about your confidence about that referral pathway, of being able to get these patients with say then CDC, perhaps in the wider community into centers able to administer.

因為我想如果您開始 DTC，則表示您對某些患者（尤其是社區患者）有很高的信心，然後可以前往專科中心進行 VISION 適應症。我想也許你可以談談你對轉診途徑的信心，能夠讓這些患者進入疾病預防控制中心，也許在更廣泛的社區進入能夠管理的中心。

And equally then, the phased dose you're talking about with the patient-ready dose. Is that at the moment, do you think, a limitation for the VISION population? Or is that very much geared towards the PSMAfore future use? Just to understand that. And if I can just ask on Germany for Pluvicto.

同樣，您所說的分階段劑量與患者準備劑量。您認為目前這對 VISION 族群來說是一個限制嗎？或者這非常適合 PSMAfore 未來的使用？只是為了理解這一點。如果我可以向德國詢問 Pluvicto。

Just is there a challenge in Europe from still from the sort of pay hospital, if you like, pharmacy created RLPs? Or are you able to overcome that, do you think, with Pluvicto?

在歐洲，是否仍然存在來自付費醫院（如果您願意的話，藥房創建的 RLP）的挑戰？或者您認為 Pluvicto 能夠克服這個問題嗎？

All very good questions, Peter. So on the referral pathways, we do feel like we're making headway into the referral pathways. But I think as you get further into the community, there is a first tendency among oncologists to cycle through chemo and potentially even cycle back to ARPI before going to a drug like Pluvicto, simply because of lack of familiarity.

所有的問題都很好，彼得。因此，在推薦途徑上，我們確實感覺到我們在推薦途徑方面正在取得進展。但我認為，當你進一步深入社區時，腫瘤學家首先傾向於循環化療，甚至可能循環回到 ARPI，然後再使用 Pluvicto 等藥物，只是因為缺乏熟悉性。

As we move away from special centers where we see very high shares of Pluvicto, we now need to educate and get more comfort with making that referrals. We think part of that is physician education, hence, new sales force. But part of it as well is patient activation so that patients and caregivers can ask as cycles of chemo are completed, the next step, hopefully, will then be Pluvicto and then the referrals go out.

當我們遠離 Pluvicto 比例非常高的特殊中心時，我們現在需要進行教育並在進行推薦時更加放心。我們認為其中一部分是醫生教育，因此是新的銷售團隊。但其中一部分也是患者激活，以便患者和照護者可以在化療週期完成後詢問，下一步有望是 Pluvicto，然後轉診。

But I think alongside of that as well is continuing to also expand the capacity of community oncology centers to provide RLT without having to make a referral is I think an important -- really also for the long run for radioligand therapy, it's something important for us to establish. Those things don't happen quickly.

但我認為除此之外，繼續擴大社區腫瘤中心提供RLT 的能力，而無需進行轉診，我認為這一點很重要——實際上，從長遠來看，對於放射配體治療來說，這對我們來說也很重要建立。這些事情不會很快發生。

But I think if you go back in history, looking at things like even when chemo was introduced, but other technologies as well, you can eventually get there step by step. So that's very much what we see at the moment. And that's why we're making these additional investments to get to that next phase of growth for Pluvicto in the US.

但我認為，如果你回顧歷史，看看化療何時被引入，以及其他技術，你最終可以一步步實現這一目標。這就是我們目前所看到的情況。這就是為什麼我們要進行這些額外投資，以使 Pluvicto 在美國實現下一階段的成長。

Now we're on the patient-ready dose, the patient-ready dose, in my mind, has two opportunities for us. So first, within centers that are at very high utilization rates, there is an interest to actually give even more patients Lutathera in first-line neuroendocrine tumors for a medium and high-risk first-line neuroendocrine tumors.

現在我們正在使用患者準備劑量，在我看來，患者準備劑量對我們有兩個機會。因此，首先，在利用率非常高的中心內，有興趣實際上為更多的一線神經內分泌腫瘤患者提供 Lutathera，用於治療中風險和高風險的一線神經內分泌腫瘤。

And then also to give you even more patients to Pluvicto, maybe if they are at 50%, 60%, or at 90%, maybe they could even do more. And so by reducing the time, the chair time, the prep time for a given patient, you expand the capacity of those centers. So it's something we've been working on for some time.

然後還要為 Pluvicto 提供更多患者，也許如果他們達到 50%、60% 或 90%，也許他們甚至可以做得更多。因此，透過減少特定患者的時間、主席時間和準備時間，您可以擴大這些中心的容量。所以這是我們一段時間以來一直在努力的事情。

And then that will become even more important as we get to PSMAfore and we triple the number of patients within those centers. We want to be able to have that capacity for them to be able to treat more and more patients. And of course, chair time is what eventually could become a constraint. So we want to get ahead of that with the patient-ready dose.

然後，當我們達到 PSMAfore 並將這些中心內的患者數量增加兩倍時，這一點將變得更加重要。我們希望能夠讓他們有能力治療越來越多的患者。當然，主席時間最終可能成為一個限制。因此，我們希望透過為患者準備的劑量來搶先一步。

Now lastly, with respect to Germany, we've achieved attractive pricing in Germany. We see very strong uptake in the initial days. And we're seeing shares -- to the extent we can get the data, we're slowly but surely 80%, 90% share versus the so-called home brews or pharmacy developed RLTs. So we feel confident now with reimbursement in place that will now become the real only option for patients in the -- desiring PSMA-RLT therapy in Germany. So we're excited about the German opportunity.

最後，關於德國，我們在德國實現了有吸引力的定價。我們在最初幾天看到了非常強烈的吸收。我們看到了份額——就我們可以獲得的數據而言，與所謂的家庭釀造或藥房開發的 RLT 相比，我們緩慢但肯定地佔有 80%、90% 的份額。因此，我們現在對報銷充滿信心，這將成為德國患者想要 PSMA-RLT 治療的真正唯一選擇。因此，我們對德國的機會感到興奮。

I would say as well, China, I've recently visited RLT centers in Shanghai. There is a lot of interest in China. And you've seen us be very successful in launches, whether it's Cosentyx and Entresto, Leqvio in China. And so the opportunity there is significant (technical difficulty) to file in China in the second half of this year. We've done a groundbreaking for a new manufacturing site in China.

我還要說，中國，我最近參觀了上海的 RLT 中心。人們對中國很有興趣。你們已經看到我們在上市方面非常成功，無論是 Cosentyx 和 Entresto，還是中國的 Leqvio。因此，今年下半年在中國提出申請的機會很大（技術難度）。我們在中國的新生產基地破土動工。

And then lastly, in Japan as well, a lot of interest in RLTs. So I think the Asian market as well will give us a boost for our RLT and Pluvicto in the medium term.

最後，在日本，人們對 RLT 也很感興趣。因此，我認為亞洲市場也將在中期內為我們的 RLT 和 Pluvicto 帶來推動。

Peter Verdult, Citi.

彼得‧韋爾杜，花旗銀行。

It's Peter Verdult from Citi. Can we go big picture, please, on IRA. Just what are the latest you're hearing from your contacts about how the initial price negotiation process is going for the industry? How manageable you feel IRA is for Novartis going forward? And with pelacarsen in mind, whether there have been any developments that give you increased confidence you can get oligonucleotides to be given the same 13-year exclusivity period as biologics?

我是花旗銀行的彼得‧韋爾多 (Peter Verdult)。我們可以對 IRA 進行全面了解嗎？您從聯絡人那裡聽到的有關該行業初始價格談判流程的最新消息是什麼？您認為 IRA 對於諾華的未來有多容易管理？考慮到 pelacarsen，是否有任何進展讓您更有信心讓寡核苷酸獲得與生物製劑相同的 13 年獨佔期？

Yes. Thanks, Peter. So first, we'd say it's not a negotiation, it's government price setting. It's not a situation where a company has the opportunity to, in effect, walk away from the prices that are set by government.

是的。謝謝，彼得。首先，我們會說這不是談判，而是政府定價。事實上，在這種情況下，公司沒有機會放棄政府制定的價格。

I'd also say, while in the short term, this might be manageable on our first set of drugs. In the long run, this policy is really not good for innovation, good for patients in the United States. And the companies are managing, is managing by shifting away from small molecule medicines for (technical difficulty) therapies. And neurological diseases, maybe they can only be treated by small molecules.

我還想說，從短期來看，我們的第一組藥物可能可以解決這個問題。從長遠來看，這個政策確實不利於創新，不利於美國的病患。這些公司正在透過從小分子藥物轉向（技術難度）療法來進行管理。而神經系統疾病，或許只能透過小分子來治療。

So I think it's very important to say the policy is not a good one. It's bad for American patients, it's bad for innovation and sincerely hope that it gets corrected. Now in terms of our midterm guidance, we factored in and our single digit -- or mid-single-digit guide into the 2030s, we factored in IRA.

所以我認為說這個政策不是一個好政策是非常重要的。這對美國患者不利，對創新不利，真誠希望它得到糾正。現在，就我們的中期指導而言，我們考慮了 2030 年代的個位數——或中個位數指導，我們考慮了 IRA。

And so we manage it through a combination of the kinds of medicines we develop, the indication we go after, et cetera, and that's how we're approaching it. Can't comment on the current price setting approach that CMS is taking right now. Those prices will obviously come out in -- for Entresto in September. I think right now, our focus is very much still to shift the policy.

因此，我們透過結合我們開發的藥物種類、我們所追求的適應症等等來管理它，這就是我們處理它的方式。無法對 CMS 目前採取的定價方法發表評論。 Entresto 的這些價格顯然將於 9 月公佈。我認為現在我們的重點仍然是改變政策。

There are a few bills in play. There is a bill that is currently being discussed to, as you rightfully mentioned, correct genetically targeted therapies, a bipartisan support, has passed through multiple committees. So we continue to be hopeful that ASOs, sRNAs and related technologies will move from 9 to 13. Another bill that is being discussed is within the rare disease framework, to move off of a single rare disease to multiple rare disease drugs to have the same benefits if you're in a single rare disease.

有幾項法案正在發揮作用。正如您所正確提到的，目前正在討論一項法案，該法案旨在糾正基因標靶療法，該法案得到了兩黨的支持，並已通過多個委員會。因此，我們仍然對ASO、sRNA 和相關技術將從9 種增加到13 種抱有希望。獲得相同的藥物如果您患有單一罕見疾病，則可以獲得好處。

So if you take a case study like Scemblix, our ability to develop Scemblix beyond CML in another rare cancer is limited because of the IRAs policy. And maybe it would make sense to actually develop it in another cancer type, but difficult to do given the IRA policy.

因此，如果您進行像 Scemblix 這樣的案例研究，那麼由於 IRA 政策，我們在另一種罕見癌症中開發超越 CML 的 Scemblix 的能力受到限制。也許在另一種癌症類型中實際開發它是有意義的，但鑑於 IRA 政策，這很難做到。

So I think that's a second bill out there. And then third, there's the full correction of 9 to 13. So I think when I'm on the Hill, I have good conversations. I think there's a broad recognition that there needs to be something done because this was an unintended consequence of a poorly drafted legislation. But how that actually transpires given that we're in a political cycle, I think we'll have to see in 2021 and beyond.

所以我認為這是第二項法案。第三，從 9 點到 13 點的全面修正。 所以我認為當我在山上時，我可以進行很好的對話。我認為人們普遍認識到需要採取一些措施，因為這是立法起草不當造成的意外後果。但考慮到我們正處於政治週期，這實際上會如何發生，我認為我們必須在 2021 年及以後才能看到。

Kerry Holford, Berenberg.

凱莉·霍爾福德，貝倫貝格。

Hi. Yes, Kerry Holford, Berenberg. Just one quick question for me on remibrutinib. The delay of the filing in CSU into next year, you referenced a few CMC adjustments. So I wonder if you could provide a little more detail on that, what's required and how long the delays obviously?

你好。是的，凱瑞·霍爾福德，貝倫貝格。請教我一個關於瑞米布替尼的簡單問題。 CSU 的申請推遲到明年，您提到了 CMC 的一些調整。所以我想知道您是否可以提供更多細節，需要什麼以及明顯的延遲多長時間？

Yes, absolutely, Kerry. So in the process of finalizing our manufacturing process, we've determined that a single step in the process called nano-milling, for those who are interested needs some adjustments in terms of time and temperature to make sure that the product profile is optimal. So we're making those adjustments.

是的，絕對是，克里。因此，在最終確定我們的製造工藝的過程中，我們確定了稱為奈米銑削的工藝中的一個步驟，對於有興趣的人來說，需要在時間和溫度方面進行一些調整，以確保產品輪廓達到最佳。所以我們正在做出這些調整。

And once we make those adjustments, as was the case with Kisqali, when we made those adjustments, we have to generate stability data. And so the time to generate the stability data then drives the time line for the filing. We're certainly hopeful that we can get that stability package put together ASAP and then get the file in, because we were ready to go in the filing.

一旦我們做出這些調整，就像 Kisqali 的情況一樣，當我們做出這些調整時，我們必須產生穩定性數據。因此，產生穩定性資料的時間決定了歸檔的時間軸。我們當然希望能夠盡快整合穩定性包，然後提交文件，因為我們已經準備好提交文件了。

And unfortunately, (technical difficulty) this at a relatively late stage. So our hope is to file in the earlier part of next year and then get an approval relatively quickly thereafter. We certainly have many PRVs in hand. We have not determined yet which ones we'll use, we certainly have the capacity to use PRVs. So we hope to be able to close the gap then and make remibrutinib available for patients in the US and then eventually around the world.

不幸的是，（技術難度）這處於相對較晚的階段。因此，我們希望在明年早些時候提交申請，然後相對快速地獲得批准。我們手邊當然有很多 PRV。我們尚未確定將使用哪些，但我們當然有能力使用減壓閥。因此，我們希望能夠縮小差距，為美國患者提供瑞米魯替尼，最終為世界各地的患者提供瑞米魯替尼。

Seamus Fernandez, Guggenheim Securities.

謝默斯·費爾南德斯，古根漢證券公司。

Thanks so much for the question. So Vas, the question is really for you strategically, as you look at the growth opportunities in the industry and across the industry, oncology, immunology and now cardiovascular metabolic disease with obesity, are all core therapeutic areas.

非常感謝您的提問。因此，Vas，這個問題實際上是針對您的策略問題，當您審視該行業和整個行業的成長機會時，腫瘤學、免疫學以及現在伴隨肥胖的心血管代謝疾病都是核心治療領域。

One area that Novartis is not currently present in is obesity. You've been in a position to think strategically and act strategically in immuno-oncology, perhaps with disappointment. Just interested to get your thoughts on the opportunity for a late entry into the obesity market, and how Novartis could potentially or would potentially make sense of that strategically, whether with existing assets or only as a completely novel approach or novel mechanism moving forward? Thanks so much.

諾華目前尚未涉足的領域之一是肥胖症。您一直能夠在免疫腫瘤學領域進行策略性思考和策略性行動，但也許會感到失望。只是想了解您對後期進入肥胖市場的機會的看法，以及諾華可能或將如何從戰略上理解這一機會，無論是利用現有資產還是僅作為一種全新的方法或新穎的機制向前發展？非常感謝。

Yes. Thanks, Seamus, for the question, as you can imagine, it's something we put a lot of thought into and have looked at many of the opportunities that are out there. To address obesity, which clearly had the opportunity to have a significant health impact, not only on obesity, but many related conditions that are continuing to see in the data.

是的。謝謝謝莫斯提出這個問題，正如你可以想像的那樣，我們對此進行了很多思考，並研究了許多現有的機會。為了解決肥胖問題，這顯然有機會對健康產生重大影響，不僅對肥胖，而且對數據中持續出現的許多相關疾病也有影響。

Our view is with the current GLP, GIP, GIPR oral and injectable class of medicines, they're going to be very well served by the two leading incumbents who are doing extremely well in the market and are rapidly developing follow-on agents. And so to come in with fast follower on those two medicines even with modestly differentiated profiles will be difficult.

我們的觀點是，對於目前的 GLP、GIP、GIPR 口服和注射類藥物，它們將得到市場上表現非常出色並正在快速開發後續藥物的兩個領先現有藥物的良好服務。因此，即使這兩種藥物的概況略有差異，要獲得快速追隨者也將是困難的。

Because when those medicines come forward at the end of the decade, you will have substantial rebate walls. You will have a substantial portfolio block in place. And so very difficult to enter with just another of -- something that's relatively similar to what's already out there. You can imagine massive amounts of free drug floating around simply because of the size of the rebates that actually be out there towards the end of the decade. So we choose not to participate in that.

因為當這些藥物在本世紀末問世時，您將擁有大量回扣牆。您將擁有一個實質的投資組合區塊。因此，僅憑另一種與已有的相對相似的東西來進入是非常困難的。你可以想像大量免費毒品的流動，只是因為在本世紀末實際存在的回扣規模。所以我們選擇不參與其中。

Insofar, as we might need one of those assets as a combination asset for our own portfolio, but rather our core focus is thinking about next-generation medicines to address obesity or related conditions in cardiovascular health. That includes much more long-acting agents, either through biologics or SIA RNAs, that includes new mechanisms of action, all preclinical, but the ones that we're exploring, either that can provide dosing advantage, tolerability advantages or the ability for muscle sparing.

就目前而言，我們可能需要其中一項資產作為我們自己投資組合的組合資產，但我們的核心重點是考慮下一代藥物來解決肥胖或心血管健康相關疾病。這包括更多的長效藥物，無論是透過生物製劑還是SIA RNA，其中包括新的作用機制，所有這些都處於臨床前階段，但我們正在探索的藥物要么可以提供劑量優勢、耐受性優勢，要么可以提供肌肉保護的能力。

There could be centrally acting mechanisms that are not necessarily targeting directly the pancreas and cognitively the central pathways, but actually directly the central pathways. So those are all things we're working on. But we stick by our conviction to stay disciplined. We had the experience of coming late into PD-1 inhibitors, immuno-oncology, with lots of capital spent.

可能存在中樞作用機制，不一定直接針對胰臟和認知中樞通路，但實際上直接針對中樞通路。這些都是我們正在努力的事情。但我們堅持我們的信念，保持紀律。我們有在 PD-1 抑制劑、免疫腫瘤學領域起步較晚、投入大量資金的經驗。

In the end, probably not well spent. Rather say, where can we bring something really unique forward, gives us a unique position not only from a physician patient standpoint, but in the US, what will matter immensely. And we know this launching many cardiovascular medicines is you need a compelling proposition for payers.

最後可能花得不值。更確切地說，我們可以在哪裡帶來一些真正獨特的東西，不僅從醫生患者的角度來看，而且在美國，這都將給我們一個獨特的地位，這將是非常重要的。我們知道，推出許多心血管藥物需要對付款人提出令人信服的主張。

And coming in late with another one of the orals or injectable GLPs, GIPs, we think is not a prudent approach for us as a company. Rather look for next breakthroughs -- or breakthroughs in other areas and other areas of medicine, where that are underserved. There's enough other areas of medicine that are underserved, and we think there's plenty of opportunity for us to drive dynamic growth in those areas.

我們認為，對於我們公司來說，遲到推出另一種口服或註射 GLP、GIP 並不是一種謹慎的做法。相反，尋找下一個突破——或者在其他領域和其他醫學領域的突破，而這些領域服務不足。還有足夠多的其他醫學領域服務不足，我們認為我們有很多機會推動這些領域的動態成長。

Rajesh Kumar, HSBC.

拉傑什·庫馬爾，匯豐銀行。

Good afternoon. Just on capital allocation. You have maintained a very capital disciplined approach in terms of what sort of valuations you're paying for M&A as well as what sort of returns you're looking at. When you are in competitive situations, can you give us some color if your competitors are behaving in a similar way? And if they are not, what are the tools you have to work around that?

午安.就資本配置而言。對於您為併購支付的估值以及您所尋求的回報類型，您一直保持著非常嚴格的資本紀律方法。當你處於競爭環境時，如果你的競爭對手也有類似的行為，你能給我們一些資訊嗎？如果不是，您可以使用哪些工具來解決這個問題？

Yes. Thanks, Rajesh. So I think, obviously, I don't want to comment on specific competitors, but I'd say there's variability in terms of capital discipline. And I think now seven years in the role, I've learned the value in playing the long game, staying disciplined, not overstretching. In the end, information asymmetry is a huge disadvantage whenever you do external deals.

是的。謝謝，拉傑什。所以我認為，顯然，我不想評論特定的競爭對手，但我想說資本紀律方面存在差異。我認為，在擔任這個職位的七年裡，我學會了長期堅持、保持紀律、而不是過度緊張的價值。最後，無論何時進行外部交易，資訊不對稱都是一個巨大的劣勢。

So you have to be prudent. You've seen us shift to, again, mostly deals, sub-billion. And if anything, a handful of larger bolt-on deals. We try to stay disciplined against our financial measures. And if we are outbid and it's not within our envelope, we just walk away.

所以你必須謹慎。你已經看到我們再次轉向主要是十億以下的交易。如果有什麼不同的話，那就是一些規模更大的補充交易。我們努力遵守我們的財務措施。如果我們的出價超出了我們的負擔範圍，我們就會走開。

And we're okay with that. There will be other opportunities that come. And then rather use our capital to buy back our own shares, as we're doing it in a disciplined way. We are confident in our growth profile. As Harry mentioned, we have still $10 billion in our ongoing buyback program.

我們對此表示同意。還會有其他機會。然後用我們的資本回購我們自己的股票，因為我們正在以一種有紀律的方式這樣做。我們對我們的成長前景充滿信心。正如 Harry 所提到的，我們正在進行的回購計畫中仍有 100 億美元。

With buybacks are part of the capital allocation principles of Novartis, return capital to shareholders through dividends and buyback. And then prudent M&A where we see the opportunity to build one of our TAs or one of our technology platforms.

回購是諾華資本配置原則的一部分，透過股利和回購將資本返還給股東。然後是謹慎的併購，我們看到了建立我們的技術援助之一或技術平台之一的機會。

The reality is more and more that happens earlier, so more and more deals that are earlier on the smaller side, because there is an opportunity for where you have a differentiated view versus your competitors. You may have a different view on the science or different expertise, which allows you then to take prudent bets.

現實情況是，越來越多的交易提前發生，因此越來越多的早期交易規模較小，因為您有機會與競爭對手保持差異化的觀點。您可能對科學有不同的看法或不同的專業知識，這使您可以謹慎行事。

We, of course, always look at all opportunities. And if there's something we think we can really generate significant value and we generate the returns that we would expect from a deal, we'll, of course, go after it. But on bidding wars, we're not -- I think the company that wins like big bidding wars where companies are going to pay well beyond at least what we would say the valuation of the target asset is. Thanks for the question.

當然，我們始終關注所有機會。如果我們認為某件事確實可以產生重大價值，並且可以產生我們期望從交易中獲得的回報，那麼我們當然會追求它。但在競購戰中，我們不是——我認為，像大型競購戰那樣獲勝的公司將支付遠遠超出我們所說的目標資產估值的價格。謝謝你的提問。

Jo Walton, UBS.

喬沃爾頓，瑞銀集團。

My question comes back to Pluvicto, if I could. And just to look at the number of cycles that a patient is actually taking. I know the maximum is six. If you could tell us what you think the level is today. I think it is quite a bit below six. And how we should be thinking about that going forward into new indications? Do you think you are going to be able to expand the number of cycles? Many thanks.

如果可以的話，我的問題又回到了 Pluvicto。只需查看患者實際接受的周期數即可。我知道最多是六個。如果您能告訴我們您認為今天的水平是多少。我認為這個數字比六點低很多。我們該如何考慮新的適應症？您認為自己能夠擴大循環次數嗎？非常感謝。

Yes. I think -- Jo, thanks for the question. So right now, we're at three to four cycles per patient, which is really because -- especially in more of the community setting, we're seeing referrals that are too late, and we would really like to push the referral rate earlier. I think an earlier indication -- and so in effect, sadly, the patient might demise or ultimately progress because of the very late nature of the disease.

是的。我想——喬，謝謝你的提問。所以現在，我們為每個患者提供三到四個週期，這實際上是因為——尤其是在更多的社區環境中，我們看到轉診已經太晚了，我們真的很想更早地提高轉診率。我認為這是一個較早的跡象 - 因此實際上，可悲的是，由於疾病的晚期性質，患者可能會死亡或最終進展。

So I think rather when we get to the earlier line, this will be less of an issue. People will complete their six cycle. We have the situation where patients have been kept on chemo probably too long, they can only tolerate three cycles before ultimately succumbing to their cancer.

所以我認為，當我們到達較早的線路時，這將不再是一個問題。人們將完成他們的六個週期。我們遇到的情況是，患者化療時間可能太長，他們只能忍受三個週期，最後死於癌症。

And so that's something -- another benefit, I think, as we move into the PSMAfore population, in the hormone-sensitive population, in these healthier populations, we would expect the full six cycles, which should also give us a lift.

我認為，這是另一個好處，當我們進入 PSMAfore 人群、激素敏感人群、這些更健康的人群時，我們預計會經歷完整的六個週期，這也應該會給我們帶來提升。

So when you think from a patient volume standpoint on Pluvicto in VISION, we're actually doing pretty well. It's just I think we just need to get those referrals earlier and get the referrals deeper in the community, and that will get us, I think, back on track to that $2 billion goal globally on the VISION population and then well on track as well for the much bigger aspirations we have for the full range of indications.

因此，當您從 VISION 中 Pluvicto 的患者數量角度考慮時，我們實際上做得相當不錯。只是我認為我們只需要更早獲得這些推薦並在社區中更深入地獲得推薦，我認為這將使我們回到全球 VISION 人口 20 億美元目標的正軌，然後也走上正軌為了實現我們對全方位適應症的更大願望。

Tim Anderson, Wolfe Research.

蒂姆·安德森，沃爾夫研究中心。

Hi. If I could come back to IRA. There's no formal gag order preventing drug companies from talking about price negotiations that are ongoing. But CMS still seems to be out there telling all the companies that basically to keep quiet about it, and all the companies are obliging. And I'm trying to figure out why.

你好。如果我能回到愛爾蘭共和軍就好了。沒有正式的禁言令阻止製藥公司談論正在進行的價格談判。但 CMS 似乎仍然在那裡告訴所有公司，基本上要對此保持沉默，並且所有公司都有義務這樣做。我正在嘗試找出原因。

One could read into this that CMS doesn't want companies saying, it's no big deal. We can manage it, because that would take away from a later announcement by them about the big price concessions that they've been able to achieve. So can you kind of share your thoughts on that one aspect of IRA. Thank you.

人們可以理解這一點，CMS 不希望公司說，這沒什麼大不了的。我們可以管理它，因為這將消除他們後來宣布的有關他們已經能夠實現的大幅價格優惠的資訊。那麼您能分享一下您對 IRA 這一方面的想法嗎？謝謝。

Yes. I don't know -- I don't have much insights on that, Tim, unfortunately. But what I can say is that these are ongoing discussions, the price setting -- we continue not to call it a negotiation, the price-setting process is one that have had multiple rounds. And I think often in these situations, there's no benefit for us to particularly go public as we continue to try to finalize the discussions and take it from there.

是的。我不知道——不幸的是，蒂姆，我對此沒有太多見解。但我可以說的是，這些都是正在進行的討論，價格設定——我們仍然不稱其為談判，價格設定過程是一個已經進行了多輪的過程。我認為，在這種情況下，當我們繼續努力完成討論並從那裡開始討論時，特別公開對我們來說沒有任何好處。

I think the reality is in this initial round from my two cents, I don't -- I can't speak for CMS. But in this initial round, you have a set of medicines that are close to -- relatively close to LOE, and because of that, companies that are in generic entries within a certain period of time, and so probably many companies would say this is all manageable because it's relatively short term.

我認為現實是在第一輪中我的兩分錢，我不 - 我不能代表 CMS 發言。但在第一輪中，你有一組接近或相對接近 LOE 的藥物，因此，公司在一定時間內進入仿製藥條目，所以可能很多公司會說這是一切都是可控的，因為它是相對短期的。

When you start getting hundreds of drugs on this list and you have drugs that are earlier in their life cycle in areas where you need more time to actually generate the peak sales and the return, I mean, this compound gets uglier and uglier.

當你開始在這個清單上獲得數百種藥物，並且你的藥物處於生命週期的早期，而你需要更多時間才能真正產生高峰銷售和回報時，我的意思是，這種化合物變得越來越難看。

So I think it's just important for all of us to keep pushing the government to fix the legislation. 13 years, 15 years is manageable. Nine years for a small molecule, depending on the indication or the ability to go into multiple indications or multiple cancer types, is a challenge.

因此，我認為對我們所有人來說，繼續推動政府修改立法非常重要。 13年、15年還可以。對於小分子來說，九年是一個挑戰，取決於適應症或進入多種適應症或多種癌症類型的能力。

And the way the industry will manage it is we'll just shift away for small molecule drugs for the elderly, which means patients with oncology conditions and neuroscience conditions and certain cardiovascular conditions will suffer. And I think that's the message that policymakers need to hear.

該行業的管理方式是，我們將轉向針對老年人的小分子藥物，這意味著患有腫瘤疾病、神經科學疾病以及某些心血管疾病的患者將受到影響。我認為這是政策制定者需要聽到的信息。

Last question, I think, is from a Graham. Graham?

我認為最後一個問題來自格雷厄姆。格雷厄姆？

Your line is now open, Graham.

格雷厄姆，您的熱線現已開通。

Thank you. Great. Just a follow-up on Kesimpta, obviously had a very strong quarter there. I just wondered if you think you might need to really visit your peak guide there. And if so, when. And if you can just help us understand how far penetrated do you think you are into peak opportunity in the US and then rest of world, which now seems to be driving almost as much of the growth as the US?

謝謝。偉大的。只是 Kesimpta 的後續行動，顯然在那裡有一個非常強勁的季度。我只是想知道您是否認為您可能需要真正拜訪那裡的高峰導遊。如果是的話，什麼時候。如果您能幫助我們了解您認為您對美國以及世界其他地區（現在似乎幾乎與美國一樣推動成長）的高峰機會的滲透程度如何？

Good question, Graham. I think area of internal debate as to how big could Kesimpta be. Certainly, just to give you some numbers in the US, we have (technical difficulty) B-cell share of all patients in RRMS. So there's plenty of room to run most of that at the expense of older medicines, the so-called BRACE, as you know well. So plenty of room to create a larger -- basically, the market size for B-cell inhibition and MS could double in the United States as physicians get more and more comfortable with B-cell inhibitors.

好問題，格雷厄姆。我認為內部爭論的焦點是 Kesimpta 能有多大。當然，為了給你一些美國的數據，我們有（技術難度）RRMS 所有患者的 B 細胞比例。因此，有足夠的空間來運行其中的大部分，但以犧牲舊藥物為代價，即所謂的 BRACE，如您所知。因此，隨著醫生對 B 細胞抑制劑越來越滿意，美國 B 細胞抑制和多發性硬化症的市場規模可能會翻倍，因此有足夠的空間來創造更大的市場規模。

Similarly, we see similar dynamics in Europe. Obviously, in Asia, MS is less of a topic. So again, an opportunity for further expansion. So we're certainly looking at the peak sales potential for Kesimpta, I think when we're in a place where we can provide more precise guidance, we certainly will. I think one area, of course, we have to watch is the BTK inhibitors.

同樣，我們在歐洲也看到了類似的動態。顯然，在亞洲，多發性硬化症不再是一個話題。這又是一個進一步擴張的機會。因此，我們肯定會關注 Kesimpta 的峰值銷售潛力，我認為當我們能夠提供更精確的指導時，我們當然會這樣做。當然，我認為我們必須關注的一個領域是 BTK 抑制劑。

But as you know, the data has not been great so far. Remibrutinib is continuing on track in MS. But if anything, we now view the BTK inhibitors as perhaps supportive, but not being able to replace the B-cell monoclonal antibodies, which also gives a tailwind to Kesimpta's long-term potential as well.

但如您所知，迄今為止的數據並不理想。瑞米布替尼在多發性硬化症治療中繼續走上正軌。但如果有的話，我們現在認為 BTK 抑制劑可能具有支持作用，但無法取代 B 細胞單株抗體，這也為 Kesimpta 的長期潛力帶來了推動力。

So I think that's everything for today. So thank you all very, very much for the call. We look forward to providing you another update in Q3 and then also looking forward to seeing you all at Meet The Management in November. So thank you again.

我想這就是今天的全部。非常非常感謝大家的來電。我們期待在第三季為您提供另一次更新，並期待在 11 月的管理層見面會上與大家見面。所以再次感謝你。

Thank you. This concludes today's conference call. Thanks 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。