Novartis AG (NVS) 2023 Q2 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q2 2023 Results Release Conference Call and Live Webcast. (Operator Instructions) And 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 2023 年第二季度業績發布電話會議和網絡直播。 （操作員指示）會議正在錄製中。 （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 Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir.

接下來，我想將會議交給投資者關係全球主管 Samir Shah 先生。請繼續，先生。

Thank you very much, Sharon. And good morning and good afternoon, everybody. I want to begin by thanking you for participating in our webcast and investor call again. Before we actually start, I'm going to read the safe harbor statement.

非常感謝你，莎倫。大家早上好，下午好。首先，我要感謝您再次參與我們的網絡廣播和投資者電話會議。在我們真正開始之前，我將閱讀安全港聲明。

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. 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 U.S. Securities and Exchange Commission.

今天提供的信息包含前瞻性陳述，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、業績或成就存在重大差異。有關其中一些因素的描述，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。

Just a couple of housekeeping points. As per usual, we'll have one question per analyst when we go to the Q&A session, and you'll have time to go back again and ask a second question. And the other point is that we aim to finish today at quarter past the hour. So it's 9:15 East Coast Time and 15:15 European Time.

只是幾個內務管理要點。像往常一樣，當我們參加問答環節時，我們會向每位分析師提出一個問題，您將有時間再次返回並提出第二個問題。另一點是我們的目標是在今天一刻鐘結束。現在是東海岸時間 9:15 和歐洲時間 15:15。

And with that, I'll hand across to Vas.

接下來，我將把工作交給瓦斯。

Great. Thank you, Samir, and thanks, everyone, for joining today's call. With me today, I also have Harry Kirsch, our CFO. So let's move straight to Slide 4. And as you saw in our release earlier today, Novartis delivered strong sales growth, excellent margin expansion, and we were able to raise our full year guidance.

偉大的。謝謝薩米爾，也謝謝大家參加今天的電話會議。今天和我在一起的還有我們的首席財務官 Harry Kirsch。因此，讓我們直接進入幻燈片 4。正如您在今天早些時候發布的新聞稿中看到的那樣，諾華實現了強勁的銷售增長和出色的利潤率擴張，並且我們能夠提高全年指導。

Getting into the numbers, our group sales grew at 9% and core op inc at 17%. IM sales were up 9% and core op inc up 20%, allowing us to drive our IM margin to 39%. And Sandoz sales were up 8% and core op inc up 6%. Harry will go through the guidance in more detail, but as you saw, we raised our full year guidance for both sales and core operating income.

從數字來看，我們的集團銷售額增長了 9%，核心業務增長了 17%。 IM 銷售額增長了 9%，核心業務增長了 20%，這使我們能夠將 IM 利潤率提高到 39%。 Sandoz 銷售額增長 8%，core op inc 增長 6%。哈利將更詳細地介紹該指導意見，但正如您所看到的，我們提高了銷售和核心營業收入的全年指導意見。

We had a number of innovation milestones as well as other strategic milestones over the course of the quarter. And when we go through those over the course of my slides. In addition, you saw that there was a ruling from the District Court regarding one of our patents for Entresto, our combination patent, where, in the process of appealing that patent and feel our arguments are strong to ultimately prevail on appeal, though that process will take 12 to 18 months. We would note there are currently no generics that are currently approved for Entresto. And also of note, in our assessment of recent history, there hasn't been an at-risk launch on a product of Entresto size in at least 15 years.

在本季度中，我們實現了許多創新里程碑以及其他戰略里程碑。當我們在幻燈片中瀏覽這些內容時。此外，您還看到地方法院就我們的一項 Entresto 專利（我們的組合專利）做出了一項裁決，在對該專利提出上訴的過程中，我們認為我們的論點很有說服力，最終在上訴中獲勝，儘管該過程需要12至18個月。我們注意到，目前沒有任何仿製藥被批准用於 Entresto。另外值得注意的是，根據我們對近期歷史的評估，至少 15 年來沒有推出過 Entresto 規模的產品。

So we'll continue to fully defend our IP citizens petitions and other elements of our strategy to enable Entresto to have as long an exclusivity period as we believe it deserves.

因此，我們將繼續全力捍衛我們的知識產權公民請願書和我們戰略的其他要素，以使 Entresto 能夠擁有我們認為應有的較長獨占期。

Now moving to the next slide. Our Q2 growth was driven by strong performance across our key growth drivers. You can see each of our key brands, Entresto, Kesimpta, Pluvicto, Kisqali, Scemblix, Leqvio, all delivered excellent performance in the quarter. And I think this reflects a combination of our new strategy or refresh strategy of focus in 5 key therapeutic areas, as well as our streamlined organization from our transformation last year. That's delivering outstanding growth in market from a top line standpoint, but also delivering strong performance on the bottom line as well. We're going to take each one of those brands in turn in the subsequent slides.

現在轉到下一張幻燈片。我們第二季度的增長是由主要增長動力的強勁表現推動的。您可以看到我們的每個主要品牌，Entresto、Kesimpta、Pluvicto、Kisqali、Scemblix、Leqvio 在本季度都表現出色。我認為這反映了我們在 5 個關鍵治療領域的新戰略或重點更新戰略的結合，以及我們去年轉型後精簡的組織。從收入的角度來看，這不僅帶來了市場的顯著增長，而且還帶來了強勁的利潤表現。我們將在接下來的幻燈片中依次介紹這些品牌中的每一個。

Now moving to Slide 6. Entresto delivered strong double-digit growth in all geographies. The brand grew 37% on the quarter, and you can see robust growth, both ex-U.S. and U.S. On the U.S. side, our weekly TRx prescriptions continue to grow robustly, 38%. Sales growth, 17% NBRx growth. So really outstanding performance on the U.S. side. Ex-U.S., we had 36% constant currency growth, and that's driven by HFrEF, but as well our performance on hypertension in China and Japan.

現在轉到幻燈片 6。Entresto 在所有地區都實現了強勁的兩位數增長。該品牌本季度增長了 37%，您可以看到強勁的增長（美國除外）。在美國方面，我們的每週 TRx 處方繼續強勁增長，增長了 38%。銷售額增長，NBRx 增長 17%。美國方面的表現非常出色。除美國外，我們的貨幣持續增長率為 36%，這是由 HFrEF 推動的，同時也是我們在中國和日本在高血壓方面的表現。

We remain confident in the outlook for Entresto's continued growth, both driven by guidelines, its HFrEF indication, but as well as continued use in the HFpEF indication. And importantly, our pediatric approval in the EU confirms that we have regulatory data protection through November of 2026.

我們對 Entresto 的持續增長前景仍然充滿信心，這既受到指導方針、其 HFrEF 適應症的推動，也受到 HFpEF 適應症的持續使用的推動。重要的是，我們在歐盟獲得的兒科批准證實我們在 2026 年 11 月之前擁有監管數據保護。

Now moving to Slide 7. In Cosentyx, our sales stabilized in Cosentyx in the second quarter, with sales up 1%. When you dive in a little bit deeper into Cosentyx performance, you saw U.S. sales down 12% in constant currency. And this was a situation where volume growth was offset by revenue deductions as we outlooked in Q1. There's also the matter of the base impact we had in the previous year from the revenue deduction true-ups we took in the second half of the year, which weren't accounted in the first half of 2022, leading to a higher base last year.

現在轉到幻燈片 7。在 Cosentyx 中，我們在第二季度的 Cosentyx 銷售額穩定，銷售額增長了 1%。當您更深入地了解 Cosentyx 的表現時，您會發現按固定匯率計算，美國銷售額下降了 12%。正如我們對第一季度的展望，這種情況是銷量增長被收入扣除所抵消。還有一個問題是，我們去年下半年的收入扣除真實數據對基數產生了影響，而 2022 年上半年並未計入這些影響，導致去年的基數較高。

Ex-U.S. sales were up 18% across -- with growth across all of our core indications. And importantly, in China, we're seeing outperformance versus the market with double-digit growth, as the China health care systems continue to stabilize. Now when you outlook to the second half, we expect important pipeline milestones with hidradenitis already approved in the EU. In the U.S., we expect to get approvals of both HS and R-IV formulation, which would allow us to penetrate the Part B segment with respect to Cosentyx, with rheumatologists who continue to use IV formulations of these medicines.

前美國我們所有核心指標的銷售額均增長了 18%。重要的是，隨著中國醫療保健系統的持續穩定，我們在中國看到了兩位數增長，優於市場。現在，當您展望下半年時，我們預計歐盟已經批准了汗腺炎的重要管道里程碑。在美國，我們期望獲得 HS 和 R-IV 製劑的批准，這將使我們能夠滲透到 Cosentyx 的 B 部分細分市場，風濕病學家繼續使用這些藥物的 IV 製劑。

And the 300-milligram auto-injector was also -- we also received approval for -- from an LCM standpoint, 3 important programs continue to progress on track: giant cell arteritis; PMR; and rotator cuff tendinopathy. We did terminate our lupus nephritis program based on a lack of compelling efficacy.

從 LCM 的角度來看，300 毫克自動注射器 - 我們也獲得了批准 - 3 個重要項目繼續按計劃取得進展：鉅細胞動脈炎； PMR；和肩袖肌腱病。由於缺乏令人信服的療效，我們確實終止了狼瘡腎炎項目。

Now moving to the next slide. Kisqali continued strong momentum globally. And I think this is a testament to its excellent differentiated profile. You had 66% growth across the globe driven both by the U.S. and ex-U.S. markets. Our NBRx share now in the U.S. has climbed to 34% on the 3-month rolling, and we continue to see strong month-to-month growth on our NBRx share. And this is, of course, driven by data you all know well, the consistent efficacy we showed in the metastatic setting across MONALEESA-2, 7 and 3, which show that the medicine has consistent benefit regardless of patient status or combination therapy.

現在轉到下一張幻燈片。 Kisqali 在全球範圍內繼續保持強勁勢頭。我認為這證明了其卓越的差異化形象。在美國和美國以外地區的推動下，您在全球範圍內實現了 66% 的增長。市場。目前，我們的 NBRx 在美國的份額在 3 個月的滾動中已攀升至 34%，並且我們繼續看到我們的 NBRx 份額逐月強勁增長。當然，這是由眾所周知的數據驅動的，我們在 MONALEESA-2、7 和 3 的轉移性環境中顯示出一致的療效，這表明無論患者狀況或聯合治療如何，該藥物都具有一致的益處。

The medicine is included in the NCCN guidelines is the only category 1 treatment for first-line metastatic breast cancer with an aromatase inhibitor.

該藥物被納入 NCCN 指南，是唯一使用芳香酶抑製劑治療轉移性乳腺癌的 1 類藥物。

Now moving to the next slide. Our NATALEE results, which we unveiled at ASCO earlier this summer, build on that differentiated profile, allowing us to demonstrate the potential benefits of Kisqali in a broad population of Stage II and Stage III early breast cancer patients. As a reminder, we had very consistent results across iDFS, RFS, distant disease-free survival and OS. And those consistent results is what give us confidence that we'll be able to achieve a broad label in the early breast cancer setting.

現在轉到下一張幻燈片。今年夏天早些時候，我們在 ASCO 上公佈了 NATALEE 結果，該結果建立在這種差異化特徵的基礎上，使我們能夠證明 Kisqali 對廣大 II 期和 III 期早期乳腺癌患者的潛在益處。提醒一下，我們在 iDFS、RFS、遠處無病生存率和 OS 方面獲得了非常一致的結果。這些一致的結果讓我們有信心能夠在早期乳腺癌領域獲得廣泛的標籤。

Importantly, as well, we saw a positive OS trend already at this early interim analysis. Now in terms of safety, there were no new safety signals to 400-milligram dose was well tolerated with limited need for dose reductions. AE-related discontinuations were mostly protocol mandated due to lab findings. The most frequent AEs were neutropenia and were liver related. And we had low rates of grade 3 symptomatic AEs, particularly with respect to GI-related symptoms.

同樣重要的是，我們在早期中期分析中已經看到了積極的操作系統趨勢。現在就安全性而言，沒有新的安全信號表明 400 毫克劑量的耐受性良好，減少劑量的需要有限。與 AE 相關的停藥大多是根據實驗室發現的方案強制執行的。最常見的 AE 是中性粒細胞減少症，且與肝臟相關。我們的 3 級症狀性 AE 發生率較低，尤其是胃腸道相關症狀。

Now moving to Slide 10. The next steps for Kisqali will be continued momentum in the metastatic breast cancer setting, where you see strong performance across our key geographies. And we want to continue to drive that momentum as we believe Kisqali is becoming the standard of care in the metastatic space. NATALEE update and analysis for iDFS and OS is expected in the second half of 2023.

現在轉到幻燈片 10。Kisqali 的下一步將是在轉移性乳腺癌領域繼續保持勢頭，您會看到我們在關鍵地區的強勁表現。我們希望繼續推動這一勢頭，因為我們相信 Kisqali 正在成為轉移領域的護理標準。 NATALEE 預計將於 2023 年下半年對 iDFS 和操作系統進行更新和分析。

We expect filings in the EU in Q3, and U.S. in Q4 at the FDA, we like a greater information fraction on the OS analysis to allow us to get to the filing in Q4 of this year. And we're pursuing a broad label reflecting the intention to treat population studied in NATALEE. So collectively, we believe that NATALEE has enabled Kisqali to have the potential to more than double the number of patients who could benefit from a treatment with a CDK4/6 in the early breast cancer setting.

我們預計第三季度將在歐盟提交申請，第四季度將在美國向 FDA 提交申請，我們希望獲得更多有關操作系統分析的信息，以便我們能夠在今年第四季度提交申請。我們正在尋求一個廣泛的標籤，反映治療 NATALEE 研究人群的意圖。因此，總的來說，我們相信 NATALEE 使 Kisqali 有可能使早期乳腺癌患者受益於 CDK4/6 治療的患者數量增加一倍以上。

Now moving to Slide 11. Kesimpta also had an outstanding quarter and continues its strong trajectory, doubling sales versus prior year. Sales were up 105% U.S. NBRx, you can see here, trending very well on a rolling 4 weeks. The TRx in the U.S. was up 80% and NBRx was up 43%. Our B-cell NBRx share is currently 54% of the market, and that, I think, will be a key driver going forward as the B-cell therapies continue to gain a larger and larger share of the MS market.

現在轉到幻燈片 11。Kesimpta 也有一個出色的季度，並繼續其強勁的發展軌跡，銷售額比去年翻了一番。您可以在此處看到，美國 NBRx 的銷售額增長了 105%，連續 4 週的趨勢非常好。美國的 TRx 上漲了 80%，NBRx 上漲了 43%。我們的 B 細胞 NBRx 目前佔市場的 54%，我認為，隨著 B 細胞療法繼續在 MS 市場中獲得越來越大的份額，這將成為未來的關鍵驅動力。

In Europe as well, now we're seeing strong launch momentum with 24,000 patients treated. And we're confident in the continued growth of this brand, as I mentioned, both with the expansion of B-cell therapies, but also with the compelling profile versus older therapies as well as some competing overall in the B-cell class.

在歐洲，我們也看到了強勁的啟動勢頭，已治療了 24,000 名患者。正如我所提到的，我們對這個品牌的持續增長充滿信心，不僅是因為 B 細胞療法的擴展，而且是因為與舊療法相比引人注目的形像以及 B 細胞類別中的一些整體競爭。

Now moving to Slide 12. Pluvicto continued its strong performance. And importantly, we are at a situation where supply is no longer constraining our ability to grow this brand. In quarter 2, we saw Q2 sales of $240 million. Millburn and -- was approved for the U.S. and Zaragoza was approved for the EU as sites for commercial supply of Pluvicto. And we are ramping up now additional lines in Millburn rapidly. This has allowed us to start adding new patients as well as adding new centers where we have goal to add over 100 new centers over the coming months to enable continued treatment for patients with prostate cancer with Pluvicto. And we have progressed as well our ex-U.S. reimbursement discussions.

現在轉到幻燈片 12。Pluvicto 繼續保持強勁的表現。重要的是，我們所處的情況是，供應不再限制我們發展該品牌的能力。在第二季度，我們看到第二季度的銷售額為 2.4 億美元。米爾本 (Millburn) 和 - 被批准在美國使用，薩拉戈薩 (Zaragoza) 被批准在歐盟作為 Pluvicto 的商業供應地點。我們現在正在迅速增加米爾本的額外生產線。這使我們能夠開始增加新患者並增加新中心，我們的目標是在未來幾個月內增加 100 多個新中心，以便能夠繼續使用 Pluvicto 治療前列腺癌患者。我們的前美國也取得了進步。報銷討論。

Upcoming milestones for Pluvicto will include the PSMAfore pre-taxane data presentation, and we expect a filing in the second half. In addition, the PSMA addition study is progressing on track as well. And we also expect submission and approval of our new Indianapolis site to further increase supply of Pluvicto. So we would expect a continued strong performance in this brand, and we continue to outlook at Pluvicto to exceed $1 billion in sales this year.

Pluvicto 即將到來的里程碑將包括 PSMAfore 紫杉烷前數據演示，我們預計將在下半年提交文件。此外，PSMA添加研究也正在按計劃進行。我們還預計印第安納波利斯新工廠的提交和批准將進一步增加 Pluvicto 的供應。因此，我們預計該品牌將繼續保持強勁表現，並且我們繼續預計 Pluvicto 今年的銷售額將超過 10 億美元。

And moving to Leqvio. The launch continues to progress steadily as we've outlooked, and we continue to gain broader and broader utilization and adapt amongst cardiovascular providers in the United States. Sales reach $78 million globally. We now have 2,600 facilities that have ordered Leqvio, which is a solid increase versus quarter 1. We are expanding buy-and-bill as the primary mode of acquisition of Leqvio consistently now over time.

並搬到萊克維奧。正如我們所預期的那樣，該產品的推出將繼續穩步推進，並且我們將繼續在美國心血管服務提供商中獲得越來越廣泛的利用和適應。全球銷售額達到 7800 萬美元。現在，我們有 2,600 家工廠訂購了 Leqvio，這與第一季度相比有了大幅增長。隨著時間的推移，我們正在不斷擴大購買和賬單作為收購 Leqvio 的主要模式。

And one of our key areas of focus is to drive greater depth amongst early adopters of Leqvio. In general, we find that once physicians reach a certain comfort level with the medicine along with their office staff, then we can reach a significant number or proportion of patients in a given office or clinic, ultimately receiving Leqvio to lower elevated cholesterol.

我們重點關注的領域之一是進一步深入了解 Leqvio 的早期採用者。一般來說，我們發現，一旦醫生及其辦公室工作人員對藥物達到一定的舒適度，那麼我們就可以接觸到特定辦公室或診所中相當數量或比例的患者，最終接受 Leqvio 來降低升高的膽固醇。

We've demonstrated already, as you are aware, consistent safety profile for this medicine. But importantly, in the last few weeks, we've also achieved a label expansion in the U.S., which expands Leqvio to patients with primary hyperlipidemia and that, in effect, allows us to move into the primary prevention setting. Less restrictive language for use for statin therapy, meaning that patients do not have to be on a maximally tolerated statin to initiate Leqvio, as well as the removal of several adverse reactions from the safety section. So this will give us an additional catalyst to help us continue to drive broader Leqvio adoption in the U.S. and around the world.

如您所知，我們已經證明了該藥物的一致安全性。但重要的是，在過去幾周里，我們還在美國實現了標籤擴展，將 Leqvio 擴展到原發性高脂血症患者，這實際上使我們能夠進入一級預防環境。他汀類藥物治療使用的限制性語言較少，這意味著患者不必服用最大耐受的他汀類藥物即可啟動 Leqvio，並且從安全部分刪除了一些不良反應。因此，這將為我們提供額外的催化劑，幫助我們繼續推動 Leqvio 在美國和世界各地的更廣泛採用。

Now looking at Scemblix sales. Scemblix sales were strong in the quarter. This brand continues to outperform our internal expectations. Sales reached $106 million in the quarter. This is driven by our new patient share in the third-line setting, where we've reached now 35%, and we've had a 16% increase of monthly prescribers on the brand, as well as the global rollout of the medicine in Germany and Japan.

現在看看 Scemblix 的銷售情況。 Scemblix 本季度銷售強勁。該品牌的表現繼續超出我們的內部預期。該季度銷售額達到 1.06 億美元。這是由我們在三線環境中的新患者份額推動的，目前我們已達到 35%，該品牌的每月處方者增加了 16%，以及該藥物在全球的推廣德國和日本。

I think one of the compelling things of this therapy are excellent efficacy, but also an outstanding safety profile, which clinicians and patients appreciate. And we continue to work to advance Scemblix data set to enable it to be used in earlier lines. The ASC4FIRST first-line registrational study has completed enrollment, and we expect readout and filing in the early part of next year. And we also continue to do additional studies to further profile sublet in the second-line setting as well as in combinations with second-generation TKIs.

我認為這種療法最引人注目的地方之一是卓越的療效，而且具有出色的安全性，受到臨床醫生和患者的讚賞。我們將繼續努力改進 Scemblix 數據集，使其能夠在早期生產線中使用。 ASC4FIRST 一線註冊研究已完成入組，我們預計將於明年初讀出並歸檔。我們還繼續進行更多研究，以進一步分析二線環境中的轉租以及與第二代 TKI 的組合。

Then moving to Slide 15 and turning to our pipeline. A couple of notes here. Our key 2023 readouts are on track. That includes the Kisqali data, which I've already mentioned; the Pluvicto updated analysis, which I've also mentioned; as well as iptacopan, where you're aware, we've filed in both -- PNH both in the U.S. and the EU. We used of priority review voucher as well in the U.S. We also are on track to read out the APPLAUSE-IgAN Phase III study in quarter 4 as well as the APPEAR-C3G data readout as well in Q4 of 2023.

然後轉到幻燈片 15 並轉向我們的管道。這裡有一些註釋。我們的 2023 年關鍵數據已步入正軌。這包括我已經提到過的 Kisqali 數據；我也提到過 Pluvicto 更新的分析；以及 iptacopan，您知道，我們已在美國和歐盟的 PNH 中提交了申請。我們在美國也使用了優先審評憑證。我們也有望在第 4 季度讀出 APPLAUSE-IgAN III 期研究，並在 2023 年第 4 季度讀出 APPEAR-C3G 數據。

Now turning to the next slide. When you look ahead now to the potential readout that we have -- expected readouts we have in the 2024, 2025 time frame, these also are on track. Remibrutinib will have its primary analysis in CSU, chronic spontaneous urticaria, in the second half of this year, with the final 52-week readout required for regulatory submission in the U.S. in 2024. I've already covered Scemblix and Pluvicto.

現在轉到下一張幻燈片。當你現在展望我們所擁有的潛在數據時——我們在 2024 年、2025 年時間範圍內的預期數據，這些數據也都步入正軌。瑞米布替尼將於今年下半年對 CSU（慢性自發性蕁麻疹）進行初步分析，並於 2024 年向美國監管機構提交最終的 52 週讀數。我已經介紹了 Scemblix 和 Pluvicto。

Our OAV-101 gene therapy for SMA in older patients with an intrathecal administration is on track now for a readout in 2024. And pelacarsen, ianalumab and additional indications for iptacopan also all are on track, which really gives us a broad array of new medicines to enable us to drive growth in the second half of this decade and into the 2030s.

我們針對老年患者的 SMA 鞘內給藥 OAV-101 基因療法現已步入正軌，預計將於 2024 年公佈結果。pelacarsen、ianalumab 和 iptacopan 的其他適應症也都在按計劃進行，這確實為我們提供了一系列廣泛的新藥使我們能夠在本十年後半葉乃至 2030 年代推動增長。

Moving to the next slide and just to provide an update on some of our external BD&L related efforts. We've done a number of recent deals to bolster our pipeline as well as strengthen our technology platform. We have a proposed acquisition of Chinook Therapeutics, which is currently awaiting regulatory approvals. This would bring into the portfolio 2 late-stage assets for the treatment of renal diseases atrasentan and Zigakibart, which is an anti-APRIL antibody. Both have shown strong proteinuria reduction in Phase II and could provide near-term launches for -- in our portfolio.

轉到下一張幻燈片，只是提供我們一些外部 BD&L 相關工作的最新信息。我們最近完成了許多交易，以加強我們的管道並加強我們的技術平台。我們擬收購 Chinook Therapeutics，目前正在等待監管部門批准。這將為投資組合帶來 2 個用於治療腎臟疾病的後期資產 atrasentan 和 Zigakibart（一種抗 APRIL 抗體）。兩者在第二階段都顯示出顯著的蛋白尿減少作用，並且可以在我們的投資組合中提供近期的推出。

We also announced earlier this week the acquisition of DTX, which is an siRNA company, that has an asset that we expect to soon enter human clinical trials for Charcot-Marie-Tooth syndrome, but also as a platform importantly, which enables the siRNAs to be directed using a lipid technology to the central nervous system, which hopefully could open up new opportunities to treat a range of diseases with siRNAs.

我們本週早些時候還宣布收購 DTX，這是一家 siRNA 公司，我們預計該公司的資產將很快進入夏科-瑪麗-圖斯綜合徵的人體臨床試驗，而且重要的是作為一個平台，它使 siRNA 能夠使用脂質技術直接作用於中樞神經系統，這有望為用 siRNA 治療一系列疾病開闢新的機會。

We also made important acquisitions of the gene therapy from Avrobio on for cystinosis, a really debilitating disease without great therapies currently, as well as a mid-stage radioligand therapy targeting FAP from Clovis Oncology.

我們還從 Avrobio 收購了針對胱氨酸病的基因療法（這是一種目前尚無有效療法的真正使人衰弱的疾病），以及從 Clovis Oncology 收購的針對 FAP 的中期放射性配體療法。

We also continue to focus our portfolio. Consistent with our overall company strategy, we announced the proposed divestment of our front of the eye assets to Bausch & Lomb, for an upfront of $1.75 billion as well as a total consideration depending on sales milestones of $2.5 billion. We also recently terminated our option agreement for ociperlimab with BeiGene.

我們還繼續關注我們的投資組合。根據我們的整體公司戰略，我們宣布擬將我們的眼科資產剝離給博士倫，預付款為 17.5 億美元，總代價取決於 25 億美元的銷售里程碑。我們最近還終止了與百濟神州的 ociperlimab 期權協議。

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

那麼，讓我把它交給哈利。哈利？

Yes. Thank you very much, Vas. Good morning, and good afternoon, everyone. I'm now going to walk you through some of the financials for the second quarter and the first half. And as always, my comments refer to growth rates in constant currencies, unless otherwise noted. As you will see from the numbers, it has been a very strong first half of the year.

是的。非常感謝你，瓦斯。大家早上好，下午好。現在我將向您介紹第二季度和上半年的一些財務數據。與往常一樣，除非另有說明，我的評論指的是按固定匯率計算的增長率。正如您從數字中看到的那樣，今年上半年的表現非常強勁。

On Slide 19, we detailed the strength of top and bottom line performance during quarter 2 and half 1. It's really a pleasure to present results like these, which are strong across the board. Overall, we have continued the robust top and bottom line growth that we saw at the beginning of the year.

在幻燈片 19 上，我們詳細介紹了第 2 季度和第 1 季度半的頂線和底線表現的強度。很高興呈現這樣的結果，這些結果在各方面都很強勁。總體而言，我們延續了年初的強勁收入和利潤增長。

In quarter 2, sales grew 9%, with broad-based performance across our key therapeutic areas and focused geographies. Core operating income increased by 17% driven mainly by higher sales. Core EPS grew 25% to $1.83, faster and core operating income also supported by our $15 billion share buyback program, which we just finished in June.

第二季度，銷售額增長 9%，在我們的關鍵治療領域和重點地區取得了廣泛的業績。核心營業收入增長 17%，主要是由於銷售額增加。核心每股收益增長 25%，達到 1.83 美元，增長速度更快，核心營業收入也得到了我們 6 月份剛剛完成的 150 億美元股票回購計劃的支持。

Turning to the first half, sales grew 8%; core operating income, 16%; with strong core EPS growth also of 25% to $3.54. Free cash flow grew 23% to $6 billion. In summary, a very strong first half of the year as our efforts to focus and streamline the business continue to pay off.

上半年，銷售額增長8%；核心營業收入，16%；核心每股收益也強勁增長 25%，達到 3.54 美元。自由現金流增長 23%，達到 60 億美元。總而言之，今年上半年表現非常強勁，因為我們專注於和簡化業務的努力不斷得到回報。

On the next slide, Slide 20. I want to go into a bit more detail about the performance of Innovative Medicines and Sandoz. For quarter 2, Innovative Medicines sales grew 9%, which drove an increase in Innovative Medicines core operating income of 20%. Core margin improved 340 basis points versus prior year for the quarter, reaching 39% in quarter 2 for Innovative Medicines.

在下一張幻燈片（幻燈片 20）中，我想更詳細地介紹 Innovative Medicines 和 Sandoz 的業績。第二季度，創新藥物銷售額增長 9%，帶動創新藥物核心營業收入增長 20%。本季度創新藥物核心利潤率較上年同期提高 340 個基點，在第二季度達到 39%。

Sandoz net sales grew 8% for the quarter, mainly driven by Europe and the biosimilar business. Core operating income was up 6%, with a core margin at 18% for the quarter. As we move towards the anticipation of the spin-off of Sandoz, we have also provided figures for Novartis excluding Sandoz in the bottom row here. And you see the Novartis excluding Sandoz grew 9% top line and 19% on the bottom line for the quarter. Of course, these numbers are very close to Innovative Medicines' numbers, and there was also a 300 basis points growth in the core margin, which reached 37.7%, meaning we are well on track for 40% midterm margin target.

山德士本季度淨銷售額增長 8%，主要受到歐洲和生物仿製藥業務的推動。本季度核心營業收入增長 6%，核心利潤率為 18%。當我們預期山德士分拆時，我們還在底行提供了諾華（不包括山德士）的數據。你會看到諾華（不包括山德士）該季度的營收增長了 9%，淨利潤增長了 19%。當然，這些數字與創新藥物的數字非常接近，而且核心利潤率也增長了300個基點，達到37.7%，這意味著我們正在順利實現40%的中期利潤率目標。

Next slide, please. I would like to remind everyone about our capital allocation priorities. As a company, we have, of course, substantial cash generation, which we aim to distribute across both our priorities of investing in the business, and returning capital to our shareholders.

請下一張幻燈片。我想提醒大家我們的資本配置優先事項。作為一家公司，我們當然擁有大量現金生成，我們的目標是將其分配給我們的業務投資和向股東返還資本的優先事項。

In terms of investing in the business, we have one of the largest R&D budget in the industry and have spent $43 billion on R&D from 2018 to '22. Over the same period, we spent about $30 billion on bolt-on M&A opportunities.

在業務投資方面，我們擁有業內最大的研發預算之一，從 2018 年到 22 年，我們在研發上花費了 430 億美元。同一時期，我們花費了大約 300 億美元用於補充併購機會。

In terms of returning capital to shareholders, we have a strong and growing annual dividend in Swiss francs per share and have undertaken regular share buybacks at, I would say, a reasonable level. Please note that the annual dividend will not be rebased post the Sandoz spin, and Sandoz will also pay its own dividend, essentially providing a further uplift of dividends for our investors.

在向股東返還資本方面，我們每年派發的瑞士法郎股息強勁且不斷增長，並且定期進行股票回購，我想說，這是一個合理的水平。請注意，山德士分拆後，年度股息不會重新調整，山德士也將支付自己的股息，實質上是為我們的投資者提供進一步提高的股息。

With respect to share buybacks, we have today announced the continuation of our previously completed share buyback program in June with a new up to $15 billion share buyback, which we expect to complete approximately by the end of 2025. Obviously, given our strong cash flows and expected top and bottom line continued growth, we continue to have the flexibility to do both share buybacks and bolt-on M&A and BD&L deals.

關於股票回購，我們今天宣布繼續之前在 6 月份完成的股票回購計劃，新的股票回購規模高達 150 億美元，我們預計將在 2025 年底左右完成。顯然，考慮到我們強勁的現金流以及預期收入和利潤持續增長，我們繼續靈活地進行股票回購以及補充併購和 BD&L 交易。

Now to Slide 22, please. The continued strong performance so far and confident in our future growth allows us once again to raise both top and bottom line guidance for the full year of 2023. So for Innovative Medicines and Novartis, excluding Sandoz, we now expect sales to grow high single digit and core operating income to grow low double digit to mid-teens. For Novartis including Sandoz, which is a group guidance and assuming that Sandoz would remain within the group for entire 2023, we now expect sales to grow high single digit and core operating income to grow low double digit.

現在請播放幻燈片 22。迄今為止持續強勁的業績以及對未來增長的信心使我們再次提高了 2023 年全年的收入和利潤指引。因此，對於創新藥物和諾華（不包括山德士），我們現在預計銷售額將實現高個位數增長核心營業收入將增長兩位數至中位數。對於諾華（包括山德士）來說，這是一個集團指導，假設山德士將在整個 2023 年留在集團內，我們現在預計銷售額將實現高個位數增長，核心營業收入將增長低兩位數。

Our key assumptions are that no U.S. Entresto generic launches happen at risk in 2023, and also that no Sandostatin LAR generics enter in U.S. in '23.

我們的主要假設是，到 2023 年，美國不會出現 Entresto 仿製藥上市的風險，並且 23 年不會出現善寧 LAR 仿製藥進入美國的情況。

On the next slide, turning to Sandoz. Sandoz guidance is maintained for 2023. This guidance is obviously very conservative given the first half delivery, but it's also ahead of the spin-off and there are clearly upside potential to that guidance. On the next slide, please, on the assumption that Sandoz becomes an independent company, it will do so clearly from a position of strength.

在下一張幻燈片上，轉向山德士。山德士維持 2023 年的指導方針。考慮到上半年的交付情況，這一指導方針顯然非常保守，但它也提前於分拆，並且該指導方針顯然有上行潛力。請在下一張幻燈片中假設山德士成為一家獨立公司，它將明確地從實力地位出發。

First and foremost, we have built a strong leadership team around Richard with decades of generic industry experience. Second, the company has a strong pipeline with small molecule generics and biosimilars. Clearly, the sales execution has improved significantly, and Novartis has increased investments to ensure Sandoz has strong future biosimilar capabilities, including a state-of-the-art new biologics manufacturing site.

首先也是最重要的是，我們圍繞理查德建立了一支強大的領導團隊，擁有數十年的通用行業經驗。其次，該公司擁有強大的小分子仿製藥和生物仿製藥產品線。顯然，銷售執行力顯著改善，諾華增加了投資，以確保山德士擁有強大的未來生物仿製藥能力，包括最先進的新生物製劑生產基地。

These strengths will allow Sandoz to execute on its 6 strategic levers that you see on the right side. I won't go into all the details here. But you have seen Richard and his team having outlined in detail for you all of these priorities during the most recent Capital Market Days and IR roadshows.

這些優勢將使 Sandoz 能夠執行您在右側看到的 6 個戰略槓桿。我不會在這裡詳細討論所有細節。但您已經看到理查德和他的團隊在最近的資本市場日和投資者關係路演期間為您詳細概述了所有這些優先事項。

On the next page, I just want to turn to the numbers for Sandoz on the next slide. And you can see that the business has performed well with respect to sales growth for the last few quarters. Looking specifically at quarter 2 performance, sales were strong, driven by Europe biosimilars and U.S. has stabilized quarter-on-quarter. As expected, standup costs mean that the growth rate for core operating income are lower than for the top line.

在下一頁上，我只想轉到下一張幻燈片上山德士的數字。您可以看到，該業務在過去幾個季度的銷售增長方面表現良好。具體來看第二季度的業績，在歐洲生物仿製藥的推動下，銷售強勁，而美國則環比穩定。正如預期的那樣，站立成本意味著核心營業收入的增長率低於營收增長率。

Importantly, for the midterm, we expect solid mid-single-digit sales growth and core EBITDA margins to be in the mid-20s. And as a reminder, the first dividend will already be paid in 2024 for the full year 2023 performance.

重要的是，就中期而言，我們預計銷售額將實現穩定的中個位數增長，核心 EBITDA 利潤率將達到 20 多歲。需要提醒的是，第一筆股息將於 2024 年支付，以實現 2023 年全年業績。

Now turning to my final slide. The planned spinoff is well on track. Many of you have attended the Sandoz Capital Market Day and shareholder roadshows. If you have not been able to participate, there will be further opportunities to do so after the Extraordinary General Meeting. The EGM will take place on September 15, and you will receive the necessary materials, which include a shareholder brochure and listing prospectus well in advance. If you and the majority of the shareholders approve the spin-off, we will also be doing post EGM road shows in the second half of September, just in time before the expected spin-off in early Q4.

現在轉向我的最後一張幻燈片。計劃中的分拆正在順利進行。你們中的許多人都參加了山德士資本市場日和股東路演。如果您未能參加，在特別股東大會後還有進一步的機會參加。臨時股東大會將於 9 月 15 日舉行，您將提前收到必要的材料，其中包括股東手冊和上市招股說明書。如果您和大多數股東批准分拆，我們還將在 9 月下半月進行臨時股東大會後路演，正好趕在第四季度初預期分拆之前。

And with that, I'll hand it back to Vas.

有了這個，我會把它還給瓦斯。

Thank you, Harry. So moving to Slide 28. So you can see in the quarter that we demonstrated strong business momentum as we are really now well on our way to becoming a truly focused Innovative Medicines company. Very strong half 1 sales growth, robust margin expansion and that broad-based performance was across TAs and geographies.

謝謝你，哈利。現在轉到幻燈片 28。所以您可以看到，我們在本季度表現出了強勁的業務勢頭，因為我們現在確實正在成為一家真正專注於創新藥物的公司。半年銷售額增長非常強勁，利潤率強勁增長，並且跨TA和地區都有廣泛的業績。

We remain very confident in our near and midterm growth profile, including our pipeline, Kisqali, Pluvicto, iptacopan, as well as the continued performance of our other launch brands such as Kesimpta and Leqvio. We're raising our 2023 full year guidance. We are initiating, based on our confidence in our outlook and in our company, a $15 billion share buyback. We're on track for the Sandoz spin-off in early Q4 2023.

我們對我們的近期和中期增長狀況仍然非常有信心，包括我們的管道、Kisqali、Pluvicto、iptacopan，以及我們其他推出品牌（如 Kesimpta 和 Leqvio）的持續表現。我們正在上調 2023 年全年指引。基於我們對前景和公司的信心，我們正在啟動 150 億美元的股票回購。我們有望在 2023 年第四季度初分拆 Sandoz。

So with that, we can open the line for questions. One question per analyst, please. Sharon?

這樣，我們就可以打開提問熱線了。請每位分析師提一個問題。莎倫？

(Operator Instructions) And the question comes from the line of Richard Vosser from JPMorgan.

（操作員指令）這個問題來自摩根大通的理查德·沃瑟（Richard Vosser）。

A question on Entresto, please. Could you talk about your discussions with the FDA around the citizen's petition around the form of the product and whether any of the generics meet these requirements? And when we could expect an update around those discussions with the FDA?

請教一個關於 Entresto 的問題。您能否談談您與 FDA 圍繞公民請願書圍繞產品形式以及是否有仿製藥滿足這些要求進行的討論？我們什麼時候可以期待與 FDA 的討論的最新進展？

Yes. Thanks, Richard. So with citizens petition, we of course filed them and then there isn't a formal process. So we're really now awaiting FDA's decision, and there is no time line necessarily for FDA's decisions around citizens petitions. There are 2 relevant in petitions. One is the nature of any potential generic in our view is that the generic must be an exact match to Entresto, which was an important consideration in the number of generics that might be able to be ultimately approved by the agency.

是的。謝謝，理查德。因此，對於公民請願，我們當然會提交，然後就沒有正式的程序了。因此，我們現在實際上正在等待 FDA 的決定，而 FDA 對於公民請願書的決定並沒有一定的時間表。請願書中有 2 條相關內容。一是我們認為任何潛在仿製藥的性質都是仿製藥必須與 Entresto 完全匹配，這是最終能夠獲得 FDA 批准的仿製藥數量的一個重要考慮因素。

And the second is with respect to labeling and how the label needs to reflect our dosing titration as well as our overall indication statement for the medicine. So we'll await that. Typically, the agency will rule on citizens petitions prior to taking an action on any of the generics. And as we noted earlier that, as of right now, there are no approved or pending approvals of generics to our knowledge. Thank you, Richard.

第二個是關於標籤以及標籤需要如何反映我們的劑量滴定以及我們對藥物的總體適應症聲明。所以我們會等待。通常，該機構會在對任何仿製藥採取行動之前對公民請願做出裁決。正如我們之前指出的，據我們所知，截至目前，尚無已批准或待批准的仿製藥。謝謝你，理查德。

Your next question comes from the line of Jo Walton, Credit Suisse.

你的下一個問題來自瑞士信貸銀行的喬·沃爾頓。

Hello, can you hear me?

你好，你能聽到我說話嗎？

Yes. Go ahead, Jo.

是的。繼續吧，喬。

I wonder if you could just tell us a little bit more about Leqvio. You were very confident that there would be an inflection in the second half of the year. You do have a broader label.

我想知道您能否告訴我們更多有關 Leqvio 的信息。您非常有信心下半年會出現拐點。你確實有一個更廣泛的標籤。

Could you just tell us a little bit more about, say, formulary positioning, levels of reordering, how many doctors have really moved across from having tried it once to saying this is awesome and kept going, and a little bit more perhaps about the European rollout?

您能否告訴我們更多一些關於處方定位、重新排序的水平、有多少醫生真正從嘗試過一次轉變為說這太棒了並繼續下去，以及可能更多關於歐洲的情況。推出？

Yes. Thanks, Jo. With Leqvio, what we see right now is a continued expansion in the number of facilities that are ordering and the number of physicians that are ordering. On the positive side, what we see is once a physician gets beyond a certain number of patients on the medicine, roughly 4 or 5, then they really expand their practice, and they're able -- actually can drive quite a bit of depth. But then we have a group of physicians who are still at the 1 to 2 dose -- 1 to 2 patient level.

是的。謝謝，喬。通過 Leqvio，我們現在看到的是訂購的設施數量和訂購的醫生數量持續增加。從積極的一面來看，我們看到的是，一旦醫生使用藥物的患者數量超過一定數量（大約 4 或 5），那麼他們就會真正擴大他們的實踐，而且他們能夠——實際上可以推動相當多的深度。但我們有一群醫生仍然處於 1 到 2 劑量——1 到 2 名患者的水平。

And a big part of our efforts right now are to drive greater depth amongst those prescribers. Because we find once there's enough scale in a practice of understanding how to operate in Part B, that then, of course, physicians find a value proposition very compelling. In terms of coverage, we have very good coverage. We're well beyond what the PCSK9 monoclonals achieved. We're at over 75% coverage at label. And so we feel very good about the coverage. So this is really more about just going step-by-step, practice by practice and getting them comfortable with the buy-and-bill process with Part B and all of the details therein.

我們現在的很大一部分努力是在這些處方者中進行更深入的研究。因為我們發現，一旦實踐規模足夠大，了解如何在 B 部分中進行操作，那麼醫生當然會發現價值主張非常引人注目。在覆蓋範圍方面，我們的覆蓋範圍非常好。我們遠遠超出了 PCSK9 單克隆抗體所取得的成就。我們的標籤覆蓋率超過 75%。所以我們對報導感覺非常好。因此，這實際上更多的是一步一步地、一次又一次地練習，讓他們熟悉 B 部分的購買和賬單流程以及其中的所有細節。

I think we'll continue on a steady trajectory through the second half of the year. Difficult to predict when exactly an inflection will occur, but we know well from our past cardiovascular launches, whether it was Diovan or Lori or Entresto, that these things take time. But once we reach a certain level of scale, then the launch really takes off, and that's what we continue to expect for Leqvio.

我認為下半年我們將繼續保持穩定的發展軌跡。很難準確預測何時會發生變化，但我們從過去的心血管產品發布中清楚地知道，無論是 Diovan、Lori 還是 Entresto，這些事情都需要時間。但一旦我們達到一定的規模，發布就會真正起飛，這就是我們對 Leqvio 的持續期望。

Overseas, we see good performance in the European markets where we primarily launched in the private market. So very good. And now in the U.K., we are starting to see an uptick as the U.K. has rolled out some additional programs for physicians to create incentives to get their patients to goal for cholesterol. So I think that's really helping the rollout in the U.K. And then looking forward, we continue to work towards approvals in China and Japan, which should further help Leqvio's growth trajectory in the medium to long term. Thanks for the question, Jo. Next question, operator.

在海外，我們看到歐洲市場表現良好，我們主要在私人市場推出。非常好。現在在英國，我們開始看到這種情況有所上升，因為英國為醫生推出了一些額外的計劃，以激勵患者達到膽固醇目標。所以我認為這確實有助於在英國的推廣。展望未來，我們將繼續努力爭取在中國和日本獲得批准，這應該會進一步有助於 Leqvio 的中長期增長軌跡。謝謝你的提問，喬。下一個問題，操作員。

Your next question comes from the line of Emmanuel Papadakis from DB.

您的下一個問題來自 DB 的 Emmanuel Papadakis。

Maybe I can take one on Pluvicto. So just a few thoughts ahead of the PSMAfore details, which you obviously headline PFS for quite some time ago in December, but you've yet to present. So ahead of seeing the details, any thoughts on whether that will directionally look similar to vision, thoughts about how OS trends may also match and mirror that data set?

也許我可以在 Pluvicto 上拍一張。因此，在 PSMAfore 詳細信息之前，我想先談談一些想法，很明顯，您在 12 月的相當長一段時間前就將其列為 PFS 的標題，但您尚未提供。因此，在看到細節之前，是否有關於這是否會在方向上看起來與視覺相似的想法，關於操作系統趨勢如何匹配和反映該數據集的想法？

And then just a word, if we could on the supply situation, the cadence of sales for H2 and beyond. you reiterated the over $1 billion number, but how could PSMAfore reflect that addressable opportunity next year? And if it's not pushing my luck, we've got a competitor readout splash also due by the end of the year. I just love to hear your latest thoughts in terms of differentiation, mechanistic or logistics.

然後簡單說一下，我們是否可以了解下半年及以後的供應情況、銷售節奏。您重申了超過 10 億美元的數字，但 PSMAfore 如何反映明年的可利用機會？如果這不影響我的運氣的話，我們也會在今年年底前公佈競爭對手的信息。我只是想听聽您在差異化、機械或物流方面的最新想法。

Yes. Thanks, Emmanuel. So on Pluvicto, we continue to see very strong demand for this medicine. And we're really now getting back out to actively promoting and generating demand as we've gotten our supply situation stabilized and beginning to expand. So on the Vision population, we continue to see very robust growth, and we would expect, as I outlined, over $1 billion of sales. Now how much larger that gets is really just a dependent on how fast we can bring facilities online and work through the logistics of getting these centers scaled and up and running.

是的。謝謝，伊曼紐爾。因此，在 Pluvicto 上，我們繼續看到對該藥物的非常強勁的需求。隨著供應形勢穩定並開始擴大，我們現在確實正在重新積極促進和創造需求。因此，在 Vision 群體中，我們繼續看到非常強勁的增長，正如我所概述的，我們預計銷售額將超過 10 億美元。現在，這個規模能擴大多少，實際上取決於我們能夠以多快的速度將設施上線，並完成這些中心的擴展、啟動和運行的後勤工作。

Now in terms of PSMAfore, we outlined that we had a clinically meaningful, statistically significant readout in our PFS. We're now awaiting the maturation of OS. I think as everyone knows, the FDA is now requiring companies to have not just no detriment on OS on these readouts, but mature enough data set as well in terms of the information fraction available. That's why it's taken us a bit more time to get to that. But that will then enable us to provide the full data set later this year, both for rPFS and OS. And what I can say is we found the rPFS data to be clinically meaningful and we think important for clinical practice.

現在就 PSMAfore 而言，我們概述了我們的 PFS 中具有臨床意義、統計顯著性的讀數。我們現在正在等待操作系統的成熟。我想眾所周知，FDA 現在要求公司不僅不能對這些讀數的操作系統造成損害，而且還要在可用信息部分方面擁有足夠成熟的數據集。這就是為什麼我們花了更多的時間才做到這一點。但這將使我們能夠在今年晚些時候提供完整的數據集，包括 rPFS 和 OS。我能說的是，我們發現 rPFS 數據具有臨床意義，我們認為對臨床實踐很重要。

So what will that mean for demand, depending on how you -- when you speak to physicians, at least the physicians I've spoken with personally as well as her through others, a potential tripling. I mean, on the order of that level of the potential demand for the product in a given center. It's too early to say exactly the trajectory of that and it really depends on the timing of us getting the approval, which would enable them the reimbursement. But it would be a substantial, we believe, expansion of the potential for Pluvicto in the marketplace, which puts, I think, really the importance of getting our Indianapolis site fully approved and up and running later this year. That would enable us between Millburn, our site in Italy of Ria and Indianapolis to fully meet the demand.

那麼，這對需求意味著什麼，取決於你如何——當你與醫生交談時，至少是我親自交談過的醫生以及通過其他人與她交談過的醫生，可能會增加三倍。我的意思是，按照給定中心的產品潛在需求水平。現在確切地說出其軌跡還為時過早，這實際上取決於我們獲得批准的時間，這將使他們能夠獲得報銷。但我們相信，這將極大地擴展 Pluvicto 在市場上的潛力，我認為，這使得我們的印第安納波利斯工廠在今年晚些時候獲得全面批准並啟動和運行非常重要。這將使我們能夠在意大利里亞工廠米爾本和印第安納波利斯之間充分滿足需求。

In terms of the competitor, our understanding of that competitor readout is similar to PSMAfore. And I think really, this is a market that you need outstanding supply chain logistics, commercial scale, and the ability to consistently deliver for customers, not only in the U.S. and around the world. And really, we believe our key differentiators will be experienced with Pluvicto as well as the supply chain that we've built that enables confidence in the supply. I would note as well, we're continuing to pursue Pluvicto as well in other markets, so Japan, eventually, other markets in Asia as well as continued expansion in Europe.

就競爭對手而言，我們對該競爭對手讀數的理解與 PSMAfore 類似。我認為，這個市場確實需要出色的供應鏈物流、商業規模以及持續為客戶提供服務的能力，不僅在美國，而且在世界各地。事實上，我們相信我們的關鍵差異化優勢將體現在 Pluvicto 以及我們建立的供應鏈上，讓人們對供應充滿信心。我還要指出的是，我們將繼續在其他市場上開發 Pluvicto，最終在日本、亞洲其他市場以及歐洲繼續擴張。

So it's very exciting. It's an exciting medicine. I would take a moment as well to say we also invest on our broader pipeline within RLT, not only do we look at expansion of Pluvicto into the pre-metastatic setting as well as biochemical recurrence delayed castration, but as well, we have Lutathera programs looking at other types of cancers. We're advancing our FAP program, which we recently acquired, as I mentioned, from Clovis in a range of different tumors. And we have our bond basin program, which we're looking at a number of mid-stage studies as well. So a lot of things happening in the RLT space, and we continue to believe, given the infrastructure we're building and the potential to have compelling efficacy and a very good safety profile so far, with a limited number of administrations, is very compelling to both patients, providers and hospital systems.

所以這非常令人興奮。這是一種令人興奮的藥物。我還要花點時間說一下，我們還在 RLT 內投資了更廣泛的產品線，我們不僅著眼於將 Pluvicto 擴展到轉移前環境以及生化復發延遲去勢，而且我們還有 Lutathera 項目看看其他類型的癌症。我們正在推進我們的 FAP 項目，正如我提到的，我們最近從 Clovis 那裡獲得了該項目，用於治療一系列不同的腫瘤。我們有債券盆地計劃，我們也在研究一些中期研究。因此，RLT 領域發生了很多事情，我們仍然相信，考慮到我們正在建設的基礎設施以及迄今為止在有限數量的管理下具有令人信服的功效和非常好的安全性的潛力，這是非常引人注目的患者、醫療服務提供者和醫院系統。

Your next question comes from the line of Emily Field from Barclays.

您的下一個問題來自巴克萊銀行的艾米麗·菲爾德。

I just wanted to ask a question about MBL-949. I know it was updated this quarter that, that was discontinued for efficacy. But just how you're thinking about the commitment to sort of the broader cardiometabolic space inclusive of obesity? Given that you have a pretty substantial cardiovascular infrastructure from the commercial side, is that an area for potentially focused business development?

我只是想問一個關於MBL-949的問題。我知道本季度已更新，該功能已因功效而停止。但您如何看待對包括肥胖在內的更廣泛的心臟代謝空間的承諾？鑑於您在商業方面擁有相當龐大的心血管基礎設施，這是一個潛在的重點業務發展領域嗎？

Yes. Thanks, Emily. So the MBL ultimately did not have a compelling overall profile, so we're stopping that program. We do have earlier-stage efforts looking at novel mechanisms in the preclinical space in obesity and metabolism, but these are very early and I think still far away from the ultimately reaching the commercial marketplace. Our focus is cardiorenal. I mean we continue to have, of course, on top of our efforts with Entresto and Leqvio, we have pelacarsen. We have our xxb program, which is a novel mechanism looking at hypertension and heart failure. A range of programs in the clinic now in antiarrhythmic agents, as well as we're advancing a broad portfolio of siRNAs to follow up on Leqvio to address cardiovascular risk reduction. We hope with less frequent therapy and hitting multiple different drug targets at the same time.

是的。謝謝，艾米麗。因此，MBL 最終沒有具有令人信服的整體形象，因此我們將停止該計劃。我們確實在早期階段努力研究肥胖和新陳代謝的臨床前空間中的新機制，但這些還處於早期階段，我認為距離最終進入商業市場還很遠。我們的重點是心腎。當然，我的意思是，除了 Entresto 和 Leqvio 的努力之外，我們還繼續擁有 pelacarsen。我們有 xxb 計劃，這是一種針對高血壓和心力衰竭的新機制。目前臨床上有一系列抗心律失常藥物項目，並且我們正在推進廣泛的 siRNA 產品組合，以跟進 Leqvio，以解決心血管風險降低問題。我們希望減少治療頻率並同時達到多個不同的藥物靶點。

On the renal side, as I mentioned, building on iptacopan, we have the proposed acquisition of Chinook as well as our continued efforts to treat a broad range of renal diseases, where we think there's a lot of unmet need and the opportunity to bring meaningful medicines forward. So that's where we will be focusing on in the years ahead.

在腎臟方面，正如我提到的，在 iptacopan 的基礎上，我們提議收購 Chinook 以及我們繼續努力治療廣泛的腎臟疾病，我們認為在這些疾病中有很多未滿足的需求，並且有機會帶來有意義的成果藥物前進。這就是我們未來幾年將重點關注的領域。

Your next question comes from the line of Graham Parry, Bank of America.

您的下一個問題來自美國銀行格雷厄姆·帕里。

It's on interest to patent litigation again. So we understand the 938 Delaware MDL litigation that was subject to a trial in October last year is now being settled ahead of ruling. So if you could just confirm that's correct, which filers you settled with and whether the filers that were in the 659 ruling 2 weeks ago for MSN, McLeods and Hetero a part of that settlement?

專利訴訟再次引起關注。據我們了解，去年 10 月審理的 938 Delaware MDL 訴訟現已在裁決前得到解決。那麼，如果您能確認這是正確的，那麼您與哪些申報者達成了和解，以及兩週前 MSN、McLeods 和 Hetero 的 659 裁決中的申報者是否屬於該和解協議的一部分？

And then how is the 938 and 134 crystalline patents being asserted against those filers that were successful in the 659 ruling that we saw a couple of weeks ago? So overall, I guess, the broader question is, is there still a scenario where generic Entresto doesn't launch until November 2027 or later? Or do you now see that as off the cards and the latest that you could protect this being mid-2025?

那麼，我們幾週前看到的 659 裁決中成功的申請者是如何主張 938 和 134 晶體專利的呢？因此，總的來說，我想，更廣泛的問題是，是否仍然存在仿製藥 Entresto 直到 2027 年 11 月或更晚才上市的情況？或者您現在認為這是不可能的，最晚可以在 2025 年中期實現這一目標？

Yes. Thanks, Graham. So the overall Entresto situation is complex in that each one of the generic filers had different scenarios in terms of the patents that they -- we believe they've infringed and we've asserted against them. They have different approaches, which may or may not enable them to ultimately get approved depending on how FDA rules on citizens petitions. So I'm not going to get into all of the details. I can confirm that we did -- as you did note, we did settle the 938 patent with crystalline and the relevant other generics. And so that matter is closed off from our perspective.

是的。謝謝，格雷厄姆。因此，Entresto 的整體情況很複雜，因為每個仿製藥申請者在他們的專利方面都有不同的情況——我們認為他們侵犯了他們，並且我們對他們提出了指控。他們有不同的方法，這可能會也可能不會使他們最終獲得批准，具體取決於 FDA 如何對公民請願書進行裁決。所以我不會詳細介紹所有細節。我可以確認我們確實做到了——正如您所指出的，我們確實與晶體和相關的其他仿製藥解決了 938 專利問題。因此，從我們的角度來看，這件事是封閉的。

But in terms of the rest right now, our focus is on appealing the district court ruling, where we feel that we have strong grounds to ultimately prevail on appeal to continue to assert our remaining patents through the various litigations that we have ongoing, to await the citizens petition ruling. Our forecasting guidance remains unchanged at a mid-2025 forecasting guidance. We, of course, will do everything we can to extend our overall support longer -- overall exclusivity longer for Entresto.

但就目前而言，我們的重點是對地方法院的裁決提出上訴，我們認為我們有充分的理由最終在上訴中獲勝，通過我們正在進行的各種訴訟繼續主張我們剩餘的專利，等待公民請願裁決。我們的預測指引維持 2025 年中期的預測指引不變。當然，我們將盡一切努力延長我們的整體支持時間——延長 Entresto 的整體獨家經營權。

And as I mentioned as well, there's no generics currently approved. And in terms of the history here, nobody has filled that launched at risk on a brand of this size in the last 15 years. So all of that gives us confidence on the outlook on the brand. Thanks, Graham.

正如我也提到的，目前沒有仿製藥獲得批准。就歷史而言，在過去 15 年裡，沒有人敢於冒險推出如此規模的品牌。所有這些都讓我們對該品牌的前景充滿信心。謝謝，格雷厄姆。

Your next question comes from the line of Michael Leuchten, UBS.

您的下一個問題來自瑞銀集團的 Michael Leuchten。

It's Mike from UBS. Obligatory question for Harry, please. The guidance implies a less of a margin gearing from the top line in the second half. What OpEx lines would be heavier as we're heading into the second half that wouldn't allow you to gear the top line as much as we saw in the first half?

我是瑞銀集團的邁克。請向哈利提問。該指引意味著下半年的利潤率將減少。當我們進入下半年時，哪些運營支出線會更重，而不允許您像上半年那樣調整收入？

Yes, Michael, thank you for the question. So overall, maybe if we talk about Novartis ex Sandoz, right, there will be a little bit more inflation coming through on the COGS line as inventory, of course, gets used like through 6 months, if you will. Not dramatic, but a little bit there. The other one is we started to get our transformation for growth savings in quarter 4 last year.

是的，邁克爾，謝謝你的提問。因此，總的來說，也許如果我們談論諾華（Novartis）前山德士（Sandoz），對吧，隨著庫存的使用，銷貨成本線將會出現更多的通脹，當然，如果你願意的話，庫存會在 6 個月內被使用。不戲劇性，但有一點。另一個是我們從去年第四季度開始進行增長節約轉型。

So there's a bit harder comp. And of course, one is a bit conservative, maybe also so maybe there's a bit more upside coming. So overall, I do see that the sales continues to have this very good momentum. And then maybe a little bit less bottom line leverage, but still a very nice bottom line leverage, right? We have 340 basis points improvement. I think one cannot assume that it happens every quarter and every year. So those are the things.

所以比較難一些。當然，人們有點保守，也許還有更多的上行空間。總的來說，我確實看到銷售繼續保持良好的勢頭。然後也許底線槓桿會少一點，但仍然是一個非常好的底線槓桿，對吧？我們有 340 個基點的改進。我認為人們不能假設這種情況每個季度和每年都會發生。這些就是事情。

And then of course, on the group guidance, that has to do with Sandoz in the second half, expecting also a little bit higher COGS line, lower gross margin due to inflation as well as some stand-up costs. That is then on the Sandoz P&L a bit more, obviously. Will it be as much as guided? Let's -- we have to see that. Spin situation is a bit more volatile than normal ongoing business. But overall, I would say, especially for Novartis ex Sandoz, continued fantastic top and bottom line performance expected, with maybe a little bit less margin leverage than we have seen in the first 2 quarters.

當然，根據集團指導，這與下半年山德士有關，預計銷貨成本線也會略高，由於通貨膨脹以及一些固定成本，毛利率會降低。顯然，這在山德士損益表上的影響更大一些。會像引導一樣嗎？讓我們——我們必須看到這一點。旋轉情況比正常的持續業務波動更大一些。但總體而言，我想說，尤其是諾華（Novartis）前山德士公司（Novartis ex Sandoz），繼續保持預期的出色頂線和底線表現，利潤率槓桿率可能比我們在前兩個季度看到的要低一些。

Thanks, Michael. Thanks, Harry.

謝謝，邁克爾。謝謝，哈利。

Your next question comes from the line of Tim Anderson from Wolfe Research.

您的下一個問題來自沃爾夫研究中心的蒂姆·安德森。

Could I just go back to Entresto? So if generics do, in fact, launch early and at risk, how does Novartis adapt to that reality? I'm guessing you may not have significant additional cost to pull out of the organization for example, because you're still promoting other drugs in the category. So maybe you could talk about your cost levers in that worst-case scenario and then also what it would mean towards M&A strategy?

我可以回到 Entresto 嗎？那麼，如果仿製藥確實提前推出並面臨風險，那麼諾華將如何適應這一現實呢？例如，我猜您可能不會因為退出該組織而產生大量額外成本，因為您仍在推廣該類別中的其他藥物。那麼也許您可以談談在最壞情況下的成本槓桿，以及這對併購策略意味著什麼？

Yes. Thanks, Tim. As we stated, we continue to not expect generics to launch at risk given the risk of trouble damages in such a brand of this size as well as the strength of we believe our case on appeal. That said, we feel confident that in the midterm, we'll continue to hit our 4% sales and 40% margin guidance for the company ex Sandoz, as Harry outlined. And that wouldn't require us to take any additional cost out because we had already assumed Entresto would go in mid-2025 as our forecasting assumption.

是的。謝謝，蒂姆。正如我們所說，考慮到這種規模的品牌存在麻煩損害的風險，以及我們對上訴案件的信心，我們仍然預計仿製藥不會面臨上市風險。也就是說，我們有信心在中期，我們將繼續達到前山德士公司 4% 的銷售額和 40% 的利潤指導，正如 Harry 所概述的那樣。這不需要我們扣除任何額外成本，因為我們已經假設 Entresto 將於 2025 年中期上市作為我們的預測假設。

So our 5-year CAGR outlook and 40% margin outlook already assumed that Entresto will be moving out. So all of our current transformation programs, procurement programs, et cetera, as they continue to mature, would enable us to still achieve those mid-term goals. Harry, anything you want to add?

因此，我們的 5 年復合年增長率展望和 40% 的利潤率展望已經假設 Entresto 將退出。因此，我們當前所有的轉型計劃、採購計劃等，隨著它們的不斷成熟，將使我們仍然能夠實現這些中期目標。哈利，你還有什麼要補充的嗎？

I think, Tim, you're right, the majority of the marketing and sales is, of course, also on the other growth drivers. And these other growth drivers have significant potential. We talked about a few of them. right? So I do not see that there would be a significant adjustment on the cost base because of a bit earlier Entresto LOE. On the other hand, in this scenario, we are fully on defending our IP, and that's the focus here. And then, of course, driving full portfolio, including Entresto and the other great growth drivers as we go forward, and not have a distraction to the organization after having done quite a significant restructuring already. And by the way, we are ahead of our restructuring cost savings. So all of that is growing also very well, which you also see reflected in the bottom line numbers.

我認為，蒂姆，你是對的，大部分營銷和銷售當然也依賴於其他增長動力。這些其他增長動力也具有巨大的潛力。我們討論了其中的一些。正確的？因此，我認為不會因為 Entresto LOE 提前一點而對成本基礎進行重大調整。另一方面，在這種情況下，我們全力捍衛我們的知識產權，這就是這裡的重點。然後，當然，在我們前進的過程中，推動整個投資組合，包括 Entresto 和其他偉大的增長動力，並且在已經完成相當大的重組之後不會分散組織的注意力。順便說一句，我們在節省重組成本方面領先一步。因此，所有這些都增長得非常好，您也可以在底線數字中看到這一點。

Thanks, Harry. Thanks, Tim.

謝謝，哈利。謝謝，蒂姆。

Your next question comes from the line of Mark Purcell from Morgan Stanley.

您的下一個問題來自摩根士丹利的馬克·珀塞爾。

It's on Pluvicto. I wanted if you can help us understand the importance of showing a strong trend on overall survival in the PSMAfore trial, given sort of rulings and precedents the FDA has taken a bit of a tougher stance when it comes to showing an OS benefit in prostate cancer specifically?

這是在普魯維克托上。我希望您能幫助我們了解在 PSMAfore 試驗中顯示總體生存率強勁趨勢的重要性，鑑於某種裁決和先例，FDA 在顯示前列腺癌 OS 獲益方面採取了更強硬的立場具體來說？

The reason for the question is we've been asked about the relevance of the PFS benefit in patients progressing on an androgen receptor pathway inhibitor being rerandomized on alternative API, as opposed to being moved on to a taxane in the control arm. And therefore, you'd expect a high crossover rate from the control arm to predictor in this study. So recognizing, clearly, they've shown -- already shown a strong PFS benefit with the trial powered for a 44% benefit, but how important is it to show the strong OS benefit to gain approval from the regulatory authorities?

提出這個問題的原因是我們被問到，對於使用雄激素受體途徑抑製劑進行治療的患者，重新隨機使用替代 API，而不是轉移到對照組中的紫杉烷，其 PFS 益處的相關性。因此，您預計本研究中從控制臂到預測變量的交叉率較高。因此，他們清楚地認識到，已經顯示出強大的 PFS 優勢，試驗支持了 44% 的優勢，但展示強大的 OS 優勢以獲得監管機構的批准有多重要？

Yes. Very good question, Mark. So right now, our trial is designed in such a way, and our agreements with FDA is that we would need to show no detriment to OS and a compelling rPFS benefit. As you likely rightly note, there will be significant crossover in the study because these patients have few alternatives at that point in time, and so crossing over to Pluvicto after the results that we announced earlier, of course will happen.

是的。很好的問題，馬克。所以現在，我們的試驗就是這樣設計的，我們與 FDA 的協議是，我們需要證明不會損害 OS 和令人信服的 rPFS 益處。正如您可能正確地註意到的那樣，研究中將會出現顯著的交叉，因為這些患者當時幾乎沒有其他選擇，因此在我們之前宣布的結果之後當然會發生交叉到 Pluvicto。

So our current expectation is to show no detriment to OS. On an upside case, we would show a positive OS already now. And then over time, of course, the OS will mature. But with FDA, we have an agreement and understanding that there will be crossover that we'll need to account for in the study analysis.

因此，我們當前的期望是不損害操作系統。從好的方面來看，我們現在已經展示了一個積極的操作系統。當然，隨著時間的推移，操作系統將會成熟。但我們與 FDA 達成了一致和諒解，即我們需要在研究分析中考慮到交叉問題。

Your next question comes from the line of Kerry Holford from Berenberg.

您的下一個問題來自 Berenberg 的 Kerry Holford。

It's on Kesimpta. So clearly, an impressive growth this quarter. But can you talk to your expectations for this product as we head into next year and beyond? In light of the new subcutaneous competition, it looks like need to be coming, I'm referring here to the recent positive data the Roche's sub formulation of Ocrevus. So what is the risk here that you lose share to Ocrevus as a less frequently dosed subcut well-established option when asset reaches the market?

這是在凱辛普塔。很明顯，本季度的增長令人印象深刻。但是，當我們進入明年及以後時，您能談談您對該產品的期望嗎？鑑於新的皮下競爭，看起來有必要出現，我在這裡指的是羅氏 Ocrevus 子配方最近的積極數據。那麼，當資產進入市場時，作為一種不太頻繁劑量的細分成熟選項，您會失去 Ocrevus 的份額，那麼這裡的風險是什麼？

Yes. Thanks, Kerry. I think first, we'll have to see the full data set. Because I think as you know, one of the challenges with IV administered of CD20s, whether given in a long infusion or a subcu pump short infusion is do you need to steroid pretreat and what is the level of reactogenicity and injection site reactions that you're going to see with the medicine. Overall, our expectation is that the players who are currently compete -- are going to compete with one another for the market for other physicians who prefer to provide IV-administered medicines or subcu pump administered medicines in the Part B setting.

是的。謝謝，凱瑞。我認為首先，我們必須查看完整的數據集。因為我認為正如您所知，靜脈注射 CD20 的挑戰之一，無論是長時間輸注還是亞泵短輸注，您是否需要類固醇預處理，以及您的反應原性和注射部位反應的水平是多少。打算用藥看看。總體而言，我們的期望是，目前競爭的參與者將相互競爭市場，以吸引其他更喜歡在 B 部分環境中提供靜脈注射藥物或皮下泵注射藥物的醫生。

And that where Kesimpta continues to do extremely well is amongst physicians who prefer to treat their patients with at-home administered monthly medicines, and Kesimpta's outstanding efficacy and safety profile. So we're prepared if, ultimately, there is a move by our competitors to try to move into the at-home subcu administration space. But we feel confident in the Kesimpta profile. You have to remember this is a medicine that takes a minute to give yourself -- a patient to give themselves a month, so 12 minutes a year. You don't have to have any preadministration, you don't have to deal with pumps and other technologies, which I think in this patient population is greatly, greatly valued. So we think the overall proposition is clear. We have to be aware of the competition, but we feel confident in the outlook for Kesimpta.

Kesimpta 繼續表現出色的地方在於，醫生更喜歡每月在家服用藥物來治療患者，而且 Kesimpta 具有出色的功效和安全性。因此，如果我們的競爭對手最終試圖進入家庭 subcu 管理領域，我們已經做好了準備。但我們對 Kesimpta 的概況充滿信心。你必須記住，這是一種需要一分鐘才能給自己服用的藥物——病人需要一個月的時間給自己服用，所以一年需要 12 分鐘。你不需要進行任何預先給藥，你不需要處理泵和其他技術，我認為這在這個患者群體中是非常非常有價值的。所以我們認為總體主張是明確的。我們必須意識到競爭，但我們對 Kesimpta 的前景充滿信心。

Your next question comes from the line of Steve Scala from Cowen.

您的下一個問題來自 Cowen 的 Steve Scala。

Also on Entresto, but regarding the new $15 billion share repurchase. Based on what Novartis is saying, it sounds as though Novartis has every intention of fully completing the new $15 billion share repurchase by year-end 2025. Even if, for instance, a generic Entresto were to launch tomorrow, which I guess is within the realm of possibility. Is that correct? Or is the share repurchase telling us that Novartis believes the probability of a generic Entresto launch between now and year-end 2025 is essentially 0?

同樣是關於 Entresto，但涉及新的 150 億美元股票回購。根據諾華的說法，諾華似乎有意在 2025 年底之前完全完成新的 150 億美元股票回購。例如，即使明天將推出仿製藥 Entresto，我猜這也在可能性的境界。那是對的嗎？或者，股票回購是否告訴我們，諾華認為從現在到 2025 年底，推出仿製藥 Entresto 的可能性基本上為零？

So Steve, on your first question, it is correct. Our $15 billion share buyback is independent of various business scenarios including Entresto, but other business scenarios. It's based on a long-term view that we have adequate capital to pursue our internal investments as well as our external M&A and BD&L. We're confident in the outlook for the company. It's our growth outlook and, ultimately, where we believe our share price will appreciate, and believe it's prudent to buy back our shares over this period of time and returning capital to shareholders and. Also as we fundamentally believe we're undervalued versus our potential.

所以史蒂夫，關於你的第一個問題，這是正確的。我們150億美元的股票回購獨立於包括Entresto在內的各種業務場景，但也獨立於其他業務場景。這是基於我們有足夠的資本來進行內部投資以及外部併購和 BD&L 的長期觀點。我們對公司的前景充滿信心。這是我們的增長前景，最終我們相信我們的股價將會升值，並相信在這段時間內回購我們的股票並向股東返還資本是謹慎的做法。此外，我們從根本上認為，相對於我們的潛力，我們的價值被低估了。

So those are the reasons for the share buyback. And we are also confident that, while we can't exclude, as I've mentioned many times on the call today, a generic will launch at risk, we believe we have a compelling case with respect to appealing the district court ruling, a compelling case across a range of other patents that go out to 2027 or in the case of our dosing titration patent to 2036, as well as the various citizens petitions we have with the FDA. So we maintain as well our guidance for our expectation from a forecasting standpoint that there wouldn't be an Entresto generics in the U.S. before mid-2025.

這就是股票回購的原因。我們也有信心，雖然我們不能排除，正如我今天在電話會議上多次提到的那樣，仿製藥將面臨風險，但我們相信，我們有一個令人信服的案件，可以對地區法院的裁決提出上訴，令人信服的案例涉及到 2027 年到期的一系列其他專利，或者我們到 2036 年的劑量滴定專利，以及我們向 FDA 提出的各種公民請願書。因此，從預測的角度來看，我們也維持對 2025 年中期之前美國不會出現 Entresto 仿製藥的預期指引。

Your next question comes from the line of Seamus Fernandez from Guggenheim Securities.

您的下一個問題來自古根海姆證券公司的 Seamus Fernandez。

So my question is a quick one. Just on the BTK, can you potentially update us on if FDA has made any request of your preliminary data or of your ongoing clinical trials just with regard to potential risk of liver injury? You know the agency is reviewing the overall class more broadly, and this has been a stated differentiating factor. Just didn't know how long the FDA is requiring or potentially requesting Novartis study the product to kind of disabuse that potential risk.

所以我的問題是一個很快的問題。就 BTK 而言，FDA 是否已就潛在肝損傷風險的初步數據或正在進行的臨床試驗提出任何要求，您能否向我們介紹最新情況？您知道該機構正在更廣泛地審查整個班級，這是一個明確的差異化因素。只是不知道 FDA 要求或可能要求諾華公司研究該產品多長時間，以消除潛在風險。

Yes. Thanks, Seamus. So consistent with what I think they've asked other sponsors, we do have enhanced liver monitoring in our multiple sclerosis programs and (inaudible). I have to double-check, but I think also in our CSU programs. Today, we have not seen any liver signals to have been in placed on any kind of clinical hold. We continue to believe that this is not "class specific to the BTK target, but specific to the design of individual molecules in the space." And if you look at -- as we've noted, I think, in the past and you've seen, our chemical structure is quite different than the chemical structure of the other BTK inhibitors being pursued either in neuroscience or in other indications, which is why we think it has the unique profile that it does from a safety standpoint.

是的。謝謝，西莫。因此，與我認為他們向其他贊助商提出的要求一致，我們確實在多發性硬化症項目中加強了肝臟監測（聽不清）。我必須仔細檢查，但我認為在我們的科羅拉多州立大學項目中也是如此。今天，我們還沒有看到任何肝臟信號被置於任何形式的臨床擱置。我們仍然相信，這不是“特定於 BTK 目標的類，而是特定於該空間中單個分子的設計”。如果你看一下——正如我們過去所注意到的，你也已經看到了，我們的化學結構與神經科學或其他適應症中正在研究的其他 BTK 抑製劑的化學結構有很大不同，這就是為什麼我們認為從安全角度來看它具有獨特的外形。

So we're looking forward to the initial efficacy readouts in CSU in the second half of this year, which hopefully will enable us to file in CSU and get a first label in immunology for remibrutinib, and then following that up with multiple sclerosis as well as other immunology indications over time.

因此，我們期待今年下半年 CSU 的初步療效讀數，這希望將使我們能夠在 CSU 提交申請並獲得瑞米布替尼免疫學的第一個標籤，然後跟進多發性硬化症隨著時間的推移，其他免疫學指標也會出現變化。

Your next question comes from the line of Naresh Chouhan from Intrinsic Health.

您的下一個問題來自 Intrinsic Health 的 Naresh Chouhan。

Just one on Hyrimoz, please. Just trying to get a feel for how we should think about the sales trajectory over the next kind of 18 months given the importance for Sandoz. Should we -- given it's -- we've the 6 months of this year, should we expect a fast launch this year? Or will you need to negotiate the formulary position for 2024 before we get a better feel for where this can go?

請只提供一份關於 Hyrimoz 的內容。考慮到山德士的重要性，我們只是想了解一下我們應該如何考慮未來 18 個月的銷售軌跡。鑑於今年還有 6 個月的時間，我們是否應該期待今年的快速發布？或者，在我們更好地了解未來發展方向之前，您是否需要協商 2024 年的規定立場？

Yes. Thanks, Naresh. The right now I think it's early days on the Hyrimoz launch. There have been multiple competitors entering Sandoz is also entering. I would expect a slow ramp for this medicine as we continue to get strong positions with payers as well as get the infrastructure up and running to launch. But over time, we do believe this will be a meaningful growth contributor to Sandoz U.S. and, ultimately, global growth in overall biosimilars business outlook. Let me hand it over to Harry in case he has anything to add.

是的。謝謝，納雷什。我認為現在 Hyrimoz 的發布還處於早期階段。已有多家競爭對手進入，山德士也正在進入。我預計這種藥物的銷量會緩慢增長，因為我們繼續在付款人中保持強勢地位，並建立基礎設施並運行以推出。但隨著時間的推移，我們確實相信這將為山德士美國的增長做出有意義的貢獻，並最終促進全球生物仿製藥整體業務前景的增長。讓我把它交給哈利，以防他有什麼要補充的。

Thank you. No, overall, too early, Naresh, to talk about now peak sales and other things, right? The launch is just starting. And as Vas said, we get on plan formulary positions. And Keren Haruvi and the U.S. team are, of course, have prepared and now pulling through that launch. And over time, the Sandoz team is expecting that it becomes a good growth contributor.

謝謝。不，總的來說，納雷什，談論現在的銷售高峰和其​​他事情還為時過早，對吧？發射才剛剛開始。正如瓦斯所說，我們按照計劃制定職位。當然，Keren Haruvi 和美國團隊已經做好了準備，現在正在完成這一發布。隨著時間的推移，山德士團隊預計它會成為良好的增長貢獻者。

Very good. Thanks, Harry.

非常好。謝謝，哈利。

Your next question comes from the line of Peter Welford from Jefferies.

您的下一個問題來自 Jefferies 的 Peter Welford。

It's just in general on returning back to capital allocation. Just we think about the $15 billion buyback. I mean last time you did a buyback of that magnitude was obviously following the Roche disposal. Now you're doing another one again based on the underlying cash flows. But I wonder if you could just talk about whether we should read into this anything about further needs or further desire to slim down the portfolio like you did with ophthalmology, and whether or not there's any divestments that's sort of related to that? And how far you are on sort of the process of that sort of prudent focus on the core therapeutic areas?

這只是總體上回歸資本配置。我們想想 150 億美元的回購。我的意思是，上次你進行如此大規模的回購顯然是在羅氏處置之後。現在，您根據基礎現金流再次進行另一項操作。但我想知道您是否可以談談我們是否應該像您在眼科領域那樣了解進一步的需求或進一步縮小投資組合的願望，以及是否有任何與此相關的撤資？您對核心治療領域的謹慎關注進展到了什麼程度？

Yes. Thanks, Peter. I'll cover the focus, and I'll let Harry take on capital allocation. So we've done a lot, as you know. I mean if you go back 5, 6 years, between the exit of the consumer health business, Alcon, Roche take, now the proposal on Sandoz, alongside that streaming down to -- streamlining down to 5 therapeutic areas, exiting areas like liver as well as diabetes and now front of the eye, really, I think we're in the right place in terms of the therapeutic areas we're in.

是的。謝謝，彼得。我將討論焦點，並讓哈利負責資本配置。正如你所知，我們做了很多事情。我的意思是，如果你回到 5、6 年前，在消費者健康業務退出之間，愛爾康、羅氏採取，現在山德士的提案，以及精簡到 5 個治療領域，退出肝臟等領域以及糖尿病，現在就在眼前，真的，我認為就我們所在的治療領域而言，我們處於正確的位置。

There may be one-offs that we still need to do in terms of streamlining, but nothing major that we would foresee at this point in time. And really, our goal is, post the Sandoz spin, is to focus on driving the pipeline, driving the strong operational performance you're seeing and hopefully exceeding the 4% sales growth, and driving to that 40% company margin as a new Novartis ex Sandoz by 2027. From a capital allocation standpoint, Harry?

在精簡方面，我們可能仍然需要做一些一次性的事情，但目前我們預計不會發生重大事情。實際上，我們的目標是，在山德士分拆後，專注於推動管道發展，推動您所看到的強勁運營業績，並希望超過 4% 的銷售增長，並作為新的諾華公司推動 40% 的公司利潤率到 2027 年，公司將不再屬於 Sandoz。從資本配置的角度來看，Harry？

Yes. Peter, overall, of course, we do our mid- and long-term liquidity planning, right? So you could say this is simply a continuation of a very responsible capital allocation application. On the other hand, you can be also, in a very pragmatic way, from the Roche stake, we have about $6 billion left. There will be a certain debt push down to Sandoz, and that pays already for the majority of the $15 billion. On top of that, of course, we have and expect continued very good cash flows.

是的。 Peter，總的來說，我們當然會做中長期流動性規劃，對吧？所以你可以說這只是一個非常負責任的資本分配申請的延續。另一方面，你也可以以一種非常務實的方式，從羅氏的股份中，我們還剩下大約60億美元。山德士將承擔一定的債務，這已經支付了 150 億美元中的大部分。當然，最重要的是，我們擁有並預計持續良好的現金流。

And of course, in that planning, we always have still flexibility for executing our bolt-on M&A and BD&L strategy over the years. So all of that is simply a normal continuation of our capital allocation strategy, built on a very strong balance sheet. As you may know, our net debt is just $15 billion. So it's below 1x EBITDA. It's a very strong balance sheet there. We have strong cash flows. And from that standpoint, I think it's just a logic way to continue share buyback at the same time, of course, a growing dividend in Swiss franc per share for the Novartis ex Sandoz. Not rebasing after Sandoz spin, and then Sandoz will pay another dividend on top of that.

當然，在該規劃中，多年來我們始終具有執行補充併購和 BD&L 戰略的靈活性。因此，所有這一切只是我們建立在非常強大的資產負債表基礎上的資本配置策略的正常延續。如您所知，我們的淨債務僅為 150 億美元。所以它低於 1 倍 EBITDA。那裡的資產負債表非常強勁。我們擁有強勁的現金流。從這個角度來看，我認為這只是繼續股票回購的一種邏輯方式，當然，諾華（Novartis ex Sandoz）的每股瑞士法郎股息不斷增長。山德士分拆後不重新調整基數，然後山德士將在此基礎上支付另一筆股息。

So I would say it's a logic extension of our capital allocation that provides us a lot of still flexibility on M&A and BD&L. But we focus on bolt-on as always.

因此，我想說，這是我們資本配置的邏輯延伸，為我們在併購和 BD&L 方面提供了很大的靈活性。但我們一如既往地專注於螺栓固定。

Thanks, Harry. Thanks, Peter.

謝謝，哈利。謝謝，彼得。

Your next question comes from the line of Andrew Baum from Citi.

您的下一個問題來自花旗銀行的安德魯·鮑姆 (Andrew Baum)。

Question for Vas on how you protect Leqvio from IRA-related price negotiation in the Medicare patients. Now I'm assuming, given the duration of exposure around, the magnitude of MACE reduction is going to massively exceed that for Repatha and Praluent, and you're probably going to get a significant fatal MI benefit as well. If those assumptions are correct, how protective you think it will be when the clock strikes after 9 years and you have price negotiation?

向 Vas 詢問如何保護 Leqvio 免受 Medicare 患者與 IRA 相關價格談判的影響。現在我假設，考慮到暴露時間，MACE 減少的幅度將大大超過 Repatha 和 Praluent，並且您可能也會獲得顯著的致命 MI 益處。如果這些假設是正確的，那麼當 9 年後時鐘敲響並且你們進行價格談判時，您認為它會有多大的保護作用？

I'm asking partly because you just opened the Victorian 1P trial, which is another large and expensive trial. So that's the first part. And the second part is just for Victorian 1P, what percentage of that trial population in the real world, do you think, is outside the Medicare patient population, and therefore immune from the impact of price negotiation?

我問這個問題的部分原因是您剛剛啟動了維多利亞 1P 試驗，這是另一個大型且昂貴的試驗。這是第一部分。第二部分僅針對維多利亞時代的 1P，您認為現實世界中的試驗人群中有多少比例不屬於 Medicare 患者群體，因此不受價格談判的影響？

Yes. Thanks, Andrew. All very good questions. So our overall strategy with Leqvio and I say this with 2 important caveats. We don't know yet exactly how, as you know, CMS is going to be looking at data sets and how they're going to ultimately transact the price negotiations. We'll understand more, I think, over the coming years. And then second, we continue to advocate for moving the 9% to 13% as an industry and as a company. And also more specifically until that big move happens, also advocating that siRNAs and related therapeutics were never intended to be part of the 9-year portion of this ruling. And there is bipartisan legislation that's been tabled at least in the Senate trying to correct that -- those issues.

是的。謝謝，安德魯。都是非常好的問題。因此，我們與 Leqvio 的總體策略和我說的有兩個重要的警告。如您所知，我們還不確切知道 CMS 將如何查看數據集以及他們將如何最終進行價格談判。我想，未來幾年我們會了解更多。其次，我們繼續倡導將 9% 作為一個行業和一家公司轉移到 13%。更具體地說，在這一重大舉措發生之前，我們還主張 siRNA 和相關療法從未打算成為該裁決的 9 年部分的一部分。至少在參議院已經提出了兩黨立法，試圖糾正這些問題。

So 2 elements of our story. One, as you rightly point out, is data. We believe that V2P, given the longer follow-up that we'll have versus the PCSK9 monoclonal antibodies, so we can hopefully show a very compelling cardiovascular risk reduction. Theoretically, that risk reduction could be in the 25% to 30% when you look at the model outcomes, which we think would be very compelling and hopefully deserving of a price premium if and when the negotiations then happen.

我們故事的兩個要素。正如您正確指出的那樣，其中之一是數據。我們相信 V2P 與 PCSK9 單克隆抗體相比，有更長的隨訪時間，因此我們有望顯示出非常引人注目的心血管風險降低效果。從理論上講，當你查看模型結果時，風險可能會降低 25% 到 30%，我們認為這將非常引人注目，並且如果談判進行的話，希望值得溢價。

V1P would give us another data leg. Now it's important to note, we don't need V1P anymore from labeling standpoint because we've already received the label from FDA without any limitations on -- in the label referring to the lack of outcomes data. So we actually have a very optimized label. Nonetheless, we think generating that data will be compelling. I don't have the exact figures, but I would say a vast majority of those patients would be -- primary prevention patients would be below 65 years of age. And so that also is another leg.

V1P 將為我們提供另一條數據。現在需要注意的是，從標籤的角度來看，我們不再需要 V1P，因為我們已經從 FDA 收到了標籤，沒有任何限制——標籤中提到缺乏結果數據。所以我們實際上有一個非常優化的標籤。儘管如此，我們認為生成這些數據將會很有吸引力。我沒有確切的數字，但我想說，這些患者中的絕大多數——一級預防患者的年齡都在 65 歲以下。這也是另一條腿。

Second, we are advancing combination programs of combination siRNAs. So 2 -- 1 is a common -- working towards combinations with HMG-CoA reductase but also looking at are there ways to extend as well the intervals at which Leqvio would ultimately have to be given. So all strategies, we're looking at as well to protect Leqvio in the long run in this situation. So I think a lot will be seen in the coming years, but clearly something that's high in our minds to make sure we can protect this medicine. As a reminder, its patents go up to -- between 2036 and 2038, so we would have a long runway if we can navigate IRA.

其次，我們正在推進組合siRNA的組合項目。因此，2 - 1 是一種常見的方法，致力於與 HMG-CoA 還原酶組合，但同時也在研究是否有方法可以延長最終必須給予 Leqvio 的時間間隔。因此，我們正在考慮所有策略，以在這種情況下長期保護 Leqvio。因此，我認為未來幾年將會發生很多事情，但顯然我們會高度重視以確保我們能夠保護這種藥物。提醒一下，它的專利有效期為 2036 年至 2038 年，因此，如果我們能夠駕馭 IRA，我們將擁有很長的跑道。

Your next question comes from the line of Simon Baker from Redburn.

您的下一個問題來自 Redburn 的 Simon Baker。

Coincidentally, it's also on -- again to Jo's question and also touching on Andrew's. Given the strong progress you're making on the number of facilities, the number on board for buy-and-bill, I just wonder if you could give us a bit more detail on (inaudible) facilities and with prescribers. What's driving in that physician inertia from getting people from putting a few people on to 4, 5 plus? Is it related to the profile of the product? Are people waiting for more data? Is it buy-and-bill? Is it Part B? If you could just give us a little bit more color on what's stopping that move. Was it simply there is a lag time between people coming on board and becoming multiple prescribers?

巧合的是，它也在播放——再次針對喬的問題，也涉及安德魯的問題。鑑於您在設施數量、購買和開票數量方面取得的巨大進展，我只是想知道您是否可以向我們提供有關（聽不清）設施和處方醫生的更多詳細信息。是什麼推動了醫生的慣性讓人們不再讓少數人使用 4、5 種以上的藥物？與產品的簡介有關嗎？人們是否在等待更多數據？是買單還是買單？是B部分嗎？如果您能給我們更多關於阻止這一舉動的原因的信息。僅僅是從加入到成為多個處方者之間存在一個滯後時間嗎？

Yes. Thanks, Simon. I think the biggest topic is just helping physician offices, inclusive of the physician understand how to navigate the Part B buy-and-bill system. I mean we still have a surprising number of physicians who ultimately file for reimbursement for Leqvio on the first 2 doses under the pharmacy benefit. And under the pharmacy benefit, they will either get rejected or go through a lot of hassle, and then that ultimately frustrates them.

是的。謝謝，西蒙。我認為最大的主題是幫助醫生辦公室（包括醫生）了解如何使用 B 部分購買和計費系統。我的意思是，我們仍然有數量驚人的醫生最終根據藥品福利申請了前 2 劑 Leqvio 的報銷。在藥品福利下，他們要么被拒絕，要么經歷很多麻煩，最終讓他們感到沮喪。

So we're really focused now on educating physicians as best we can and physician offices that you need to set up a separate pathway, buy-and-bill is a different approach. And once they actually get that experience of both having the patient get on the medicine, ultimately, there is no co-pay for many of these patients depending on the insurance that they're in. There's net cost recovery for the physician. So many benefits. And then when they get through that journey, then they expand very quickly from 2 patients to 8 patients to 10 patients to 12 patients.

因此，我們現在真正專注於盡我們所能對醫生進行教育，醫生辦公室需要建立一個單獨的途徑，購買和計費是一種不同的方法。一旦他們真正獲得了讓患者接受藥物治療的體驗，最終，許多患者就不需要支付自付費用，具體​​取決於他們所參加的保險。醫生可以收回淨成本。這麼多好處。然後，當他們完成這個旅程後，他們會很快從 2 名患者擴大到 8 名患者，再到 10 名患者，再到 12 名患者。

We're losing physicians because of that initial step of misunderstanding pharmacy versus medical, how to actually procure under buy-and-bill. I would say, frankly, we underestimated that challenge, but that doesn't change our conviction when we see how -- when physician offices do convert, how large and big they grow. It gives us the conviction that if we can get through that hurdle of getting enough offices to fully understand that there is a big runway for this project -- product coming out of that. And so that's the work we still need to work through over the coming months.

我們正在失去醫生，因為我們對藥房與醫療的誤解，以及如何在購買和計費下實際採購的第一步。坦率地說，我想說，我們低估了這一挑戰，但是當我們看到醫生辦公室確實發生轉變時，他們的規模越來越大，這並沒有改變我們的信念。它讓我們相信，如果我們能夠克服獲得足夠辦公室的障礙，就能充分了解這個項目有一個很大的跑道——產品就是由此產生的。這就是我們在未來幾個月仍需要完成的工作。

Your next question comes from the line of Eric Le Berrigaud from Stifel.

您的下一個問題來自 Stifel 的 Eric Le Berrigaud。

Actually, the question is how to reconcile the second in a row raise in the full year guidance, the midterm guidance, because after the second raise in 2023, you will end up '23 by growing probably 8% to 9%, i.e., double the expected range of growth for the 4 to 5 coming years. So how should we think about this? There are basically 2 scenarios. One, growth is very much front-end loaded and the end part of the period will show slow growth or you're just very conservative. You're surprised yourself by the strength in the business this year, and you might surprise also by the strength in the business for the next 4 to 5 years.

實際上，問題是如何協調全年指導（即中期指導）中的連續第二次加薪，因為在 2023 年第二次加薪之後，您最終將增長 8% 至 9%，即翻倍。未來4至5年的預期增長范圍。那麼我們應該如何思考這個問題呢？基本上有兩種情況。第一，增長在很大程度上是前端加載的，而該時期的結束部分將顯示出緩慢的增長，或者你只是非常保守。您對今年業務的強勁表現感到驚訝，也可能對未來 4 到 5 年業務的強勁表現感到驚訝。

Yes. Thanks for the question. I think it's a very valid point. I mean overall, right now, we want to see, obviously, the continued trajectory on these brands. Clearly, if Pluvicto, Kisqali in early breast cancer; iptacopan, Leqvio, inflection; Scemblix and particularly if Scemblix first-line comes, certainly, we have the opportunity to outperform that 4% sales growth given the outlook that we have. I mean, right now, we maintain that outlook based on what we see today. But I think certainly, our aspiration is to do better. And I think it really comes down to the outlook on those handful of brands. And if they continue to perform the way they have, there's certainly an opportunity for us to do better than what we've expected last year. Harry, anything to add on your side?

是的。謝謝你的提問。我認為這是一個非常正確的觀點。我的意思是，總的來說，現在我們顯然希望看到這些品牌的持續發展軌跡。顯然，如果Pluvicto、Kisqali處於早期乳腺癌； iptacopan、Leqvio、變形； Scemblix，特別是如果 Scemblix 一線產品上市，考慮到我們的前景，我們當然有機會超越 4% 的銷售增長。我的意思是，現在我們根據今天所看到的情況維持這種前景。但我認為，我們的願望當然是做得更好。我認為這實際上取決於這少數品牌的前景。如果他們繼續保持現有的表現，我們肯定有機會做得比去年的預期更好。哈利，你有什麼要補充的嗎？

I think, of course, the 5-year CAGR, right, is harder to lift than a 1 year. But -- obviously. On the other hand, of course, from our financial planning standpoint, the interest contributions to the current growth would not be very much at the end of the 5 years because of our mid-'25 forecast assumption, right, the outlook was to '27. So it's a technical detail that the Entresto contribution at the end of it would be lower. And that's why we also outlined at the time when we gave the 4% CAGR, if we are able to hold on to Entresto in the U.S. longer, that this 4% CAGR would get to a 5% CAGR. So we are in that range at the moment. And as Vas says, if Pluvicto, Kisqali, Kesimpta, Scemblix and continue to outperform like this, we certainly see the potential for overperformance.

當然，我認為 5 年復合年增長率比 1 年復合增長率更難提升。但是——顯然。另一方面，當然，從我們財務規劃的角度來看，由於我們 25 年中期的預測假設，5 年後利息對當前增長的貢獻不會很大，對吧，前景是 ' 27.所以這是一個技術細節，最後 Entresto 的貢獻會更低。這就是為什麼我們在給出 4% 複合年增長率時還概述了，如果我們能夠在美國持有 Entresto 更長時間，那麼 4% 的複合年增長率將達到 5% 的複合年增長率。所以我們目前處於這個範圍內。正如 Vas 所說，如果 Pluvicto、Kisqali、Kesimpta、Scemblix 繼續像這樣表現出色，我們當然會看到表現優異的潛力。

Your next question comes from the line of Rajesh Kumar from HSBC.

您的下一個問題來自匯豐銀行的 Rajesh Kumar。

If I may, looking -- just looking at the acquisitions you've done, you've announced today or you announced in the quarter. Could you run us through how you're thinking on what type of or what stage of assets you would acquire have changed, as we have an uncertainty around IRA and also a lot of your peers are also looking to acquire? So that part of capital allocation, if you could provide us with a bit more color, that would really help.

如果可以的話，我想看看你們已經完成的收購、你們今天宣布的收購或你們在本季度宣布的收購。您能否向我們介紹一下您對您將收購的資產類型或階段發生變化的看法，因為我們對 IRA 存在不確定性，而且您的許多同行也在尋求收購？因此，如果您能為我們提供更多關於資本配置的部分的信息，那將非常有幫助。

Yes, absolutely. I mean generally, you see us moving to mid-stage and earlier. And as we've always guided, the bolt-on range or smaller deals with Chinook, as you saw, it was in that $3 billion range, so I think very much in line with what we've guided. We are carefully looking at assets in terms of potential IRA impact and ensuring that we think we have opportunities to either manage the IRA impact or avoid the IRA impact, certainly with conditions like Charcot-Marie-Tooth, cystinosis. These are areas where you wouldn't be impacted by IRA as best as we currently see those patient populations.

是的，一點沒錯。我的意思是，一般來說，你會看到我們進入中期或更早階段。正如我們一直指導的那樣，與 Chinook 的補充範圍或更小的交易，如您所見，在 30 億美元的範圍內，所以我認為非常符合我們的指導。我們正在仔細研究資產的潛在 IRA 影響，並確保我們認為我們有機會管理 IRA 影響或避免 IRA 影響，尤其是在腓骨肌萎縮症、胱氨酸病等情況下。這些領域不會像我們目前看到的患者群體那樣受到 IRA 的影響最大。

Certainly, on Chinook in terms of those renal assets, again, we believe that given the patient profile, overall largely manageable with respect to IRA. So that's certainly on our minds. But I think the biggest thing for us is we want assets that are in our core therapeutic areas or in our core platform technologies that have adequate risk reward, where they're derisked from the basic science, but still there's an upside that we believe we can deliver based on our capabilities. And we don't want to overpay for very large deals where assets are fully valued and it's difficult for us to find upside Novartis is contributing, and therefore, difficult to create value for our shareholders.

當然，就 Chinook 的腎臟資產而言，我們再次相信，考慮到患者的情況，總體而言 IRA 基本上是可控的。所以這肯定是我們的想法。但我認為對我們來說最重要的是我們希望我們的核心治療領域或核心平台技術中的資產具有足夠的風險回報，這些資產不受基礎科學的影響，但我們相信仍然有一個好處可以根據我們的能力交付。我們不想為資產得到充分估值的大型交易支付過高的費用，而且我們很難發現諾華正在貢獻的好處，因此很難為我們的股東創造價值。

Your next question comes from the line of Richard Parkes from BNP Paribas.

您的下一個問題來自法國巴黎銀行的理查德帕克斯。

Just one last. Just been a lot of discussion obviously about the Entresto LOE, but there's also possible a couple of smaller products that could face generics over the next few years, I'm thinking Promacta and Tasigna. So just wondered if you could update for us your latest thinking on expected first generic launches to those 2 drugs in various territories.

只剩下最後一個了顯然，關於 Entresto LOE 的討論已經有很多，但未來幾年也可能有一些較小的產品可能面臨仿製藥，我想到的是 Promacta 和 Tasigna。因此，我想知道您是否可以為我們更新您對這兩種藥物在不同地區預計首次仿製藥上市的最新想法。

Yes. I mean both with Promacta and Tasigna, there's no change to the previous expectations. We obviously are continuing to prosecute with respect to Promacta, our various patents, and seeing if there's a way we can have longer exclusivity on a Promacta. But other than that in each of the geographies, there's no change from our prior guidance on Promacta or Tasigna. Next question, operator, and this will be our last question.

是的。我的意思是 Promacta 和 Tasigna 都沒有改變之前的期望。顯然，我們正在繼續起訴 Promacta、我們的各種專利，並看看是否有辦法讓我們對 Promacta 擁有更長時間的獨占權。但除此之外，每個地區的情況與我們之前對 Promacta 或 Tasigna 的指導沒有變化。下一個問題，操作員，這將是我們的最後一個問題。

Your last question comes from the line of Graham Parry, Bank of America.

你的最後一個問題來自美國銀行格雷厄姆·帕里（Graham Parry）。

Great. We just get a follow-up in. So it's on data timing. So PSMAfore, do you think you can make ESMO with that data, let's say, 4Q, that's just into 4Q or are you thinking something later? And then on NATALEE, you talked about some additional updates later in the year. Presumably, San Antonio Breast Cancer Symposium would be a good forum for that. And given that the hazard ratio on overall survival was there approaching boardlines statistical significance, and when you look at the event rate in that trial now, is there an opportunity to see a statistically significant OS benefit this year if we sort of -- if you continue to predict event rates in line with what you've seen to date in the trial?

偉大的。我們剛剛得到了跟進。所以這是關於數據計時的。所以 PSMAfore，你認為你可以用這些數據製作 ESMO，比如說 4Q，這只是進入 4Q 或者你以後會考慮什麼？然後在 NATALEE 上，您談到了今年晚些時候的一些額外更新。據推測，聖安東尼奧乳腺癌研討會將是一個很好的論壇。考慮到總體生存率的風險比接近統計顯著性，當您現在查看該試驗中的事件發生率時，如果我們某種程度的話，今年是否有機會看到統計上顯著的 OS 獲益 - 如果您繼續根據您迄今為止在試驗中看到的情況來預測事件發生率？

Yes. Thanks Jo (sic) [Graham]. I think on both of those conferences, those would be our aspirations. Of course, we have to get the data and ultimately get accepted to the various congresses, but that's certainly in line with our current aspirations. With respect to the OS benefit, it is certainly possible given that we were at 0.76. I think it really will, of course, depend on the event rate and ultimately, what we see. But I think there's at least the possibility that we get to a statistically significant OS benefit. And then when we look at the competitor OS benefit, we hope that we can demonstrate something that's compelling on that front to build on our broad benefit that we already saw in the iDFS in Stage II and Stage III patients.

是的。謝謝喬（原文如此）[格雷厄姆]。我認為在這兩次會議上，這些都是我們的願望。當然，我們必須獲得數據並最終被各個大會接受，但這肯定符合我們當前的願望。考慮到操作系統的優勢，鑑於我們的值為 0.76，這當然是可能的。當然，我認為這確實取決於事件發生率以及最終我們所看到的情況。但我認為我們至少有可能獲得統計上顯著的操作系統優勢。然後，當我們考慮競爭對手的操作系統優勢時，我們希望能夠展示一些在這方面引人注目的東西，以我們已經在 II 期和 III 期患者的 iDFS 中看到的廣泛優勢為基礎。

So thank you all very much for joining the call. I really appreciate it. We continue to plan on delivering strong performance for the second half of the year, executing on the Sandoz spin, getting the share buyback moving and updating you with, hopefully, exciting clinical trial data over the course of the second half.

非常感謝大家加入此次電話會議。對此，我真的非常感激。我們繼續計劃在下半年提供強勁的業績，執行山德士的重組，推動股票回購，並希望在下半年向您提供令人興奮的臨床試驗數據。

I really appreciate your interest in the company, and we'll keep you updated as we continue to progress on our journey. Thank you again.

我非常感謝您對公司的興趣，隨著我們繼續前進，我們將隨時向您通報最新情況。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。您現在可以斷開連接。