Novartis AG (NVS) 2022 Q2 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q2 2022 Results Release Conference Call and Live Webcast. (Operator Instructions) The conference is being recorded. (Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.

早上好，下午好，歡迎來到諾華 2022 年第二季度業績電話會議和網絡直播。 （操作員說明）正在錄製會議。 （操作員說明）電話會議的錄音，包括問答環節，將在電話會議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.

至此，我想向投資者關係全球主管 Samir Shah 先生匯報。請繼續，先生。

Thank you very much, and thank you to all of you who have joined us today on this beautiful summer's day for Novartis' quarter 2 results.

非常感謝你們，感謝今天在這個美麗的夏日加入我們的所有人，共同見證諾華公司第二季度的業績。

Before we start, I'll just read you the Safe Harbor statement. 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 recently quarterly results on Form 6-K that, respectively, were filed with and furnished to the U.S. Securities and Exchange Commission.

在我們開始之前，我將向您宣讀安全港聲明。今天提供的信息包含涉及已知和未知風險、不確定性和其他因素的前瞻性陳述。這些可能導致實際結果與此類陳述所表達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，請參閱公司的 20-F 表格及其最近的 6-K 表格季度業績，這些業績分別提交給美國證券交易委員會並提供給美國證券交易委員會。

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

有了這個，我將交給 Vas。謝謝你。

Thank you, Samir, and thanks, everyone, for joining today's conference call. We're pleased to go over the results. I have with me today, Harry Kirsch, our CFO; and Karen Hale, our Chief Legal Officer.

謝謝你，薩米爾，謝謝大家參加今天的電話會議。我們很高興檢查結果。今天和我在一起的是我們的首席財務官 Harry Kirsch；和我們的首席法律官 Karen Hale。

Moving to Slide 4. As you saw in the release earlier today, we delivered a solid quarter 2 across each of our key value drivers, 5% growth across the entire company as well as in Innovative Medicines and Sandoz, continuing our productivity agenda with solid core operating income growth across the business as well as continued margin expansion in constant currencies as well as an upgrade to our expected savings from our transformation program to now $1.5 billion.

轉到幻燈片 4。正如您在今天早些時候的發布中所看到的，我們在每個關鍵價值驅動因素中都實現了穩健的第二季度，整個公司以及創新藥物和山德士的增長 5%，繼續我們的生產力議程以穩健整個業務的核心營業收入增長，以固定匯率計算的利潤率持續增長，以及我們從轉型計劃中節省的預期資金上調至現在的 15 億美元。

Some innovation milestones. Notably, we continue to garner approval for Scemblix, our new medicine for CML, including a positive CHMP opinion.

一些創新里程碑。值得注意的是，我們繼續獲得對 CML 新藥 Scemblix 的批准，包括積極的 CHMP 意見。

And then lastly, 3 milestones within our ESG efforts. First, the $250 million R&D commitment as part of the Kigali Declaration for neglected tropical diseases. We've increased our commitment to clinical trial diversity over the next 10 years through our Beacon of Hope project. And we also had an upgrade from MSCI to now a AA rating, top quartile within the industry. And we continue to work to further improve our overall ESG profile.

最後是我們 ESG 工作中的 3 個里程碑。首先，作為被忽視熱帶病基加利宣言一部分的 2.5 億美元研發承諾。通過我們的 Beacon of Hope 項目，我們在未來 10 年增加了對臨床試驗多樣性的承諾。我們還從 MSCI 升級到現在的 AA 評級，在行業內排名前四分之一。我們將繼續努力進一步改善我們的整體 ESG 形象。

Moving to the next slide. When you look at Innovative Medicines sales, we grew consistently across the U.S. and in our ex U.S. markets, primarily driven by our key growth drivers. We had 6% sales in the U.S., 5% sales ex U.S. And you now see on the right-hand side of the chart, 59% of our sales come from our key growth drivers, and those key growth drivers are now growing at 21%.

轉到下一張幻燈片。當您查看創新藥物的銷售時，我們在美國和美國以外的市場持續增長，這主要是由我們的主要增長驅動因素推動的。我們在美國的銷售額為 6%，在美國以外的銷售額為 5%。您現在在圖表的右側看到，我們 59% 的銷售額來自我們的關鍵增長驅動力，而這些關鍵增長驅動力現在增長為 21 %。

And moving to the next slide and zooming in a little closer on the quarter. You saw pretty consistent performance across our key medicines, and we'll go through this in a bit more detail. Two things -- 2 products I wanted to particularly call out. Kesimpta had a very strong quarter, I think, demonstrating its overall profile as a multiple sclerosis therapy of choice. And Kisqali as well is now gaining momentum in breast cancer -- in metastatic breast cancer patients, and we'll talk a little bit more about that throughout the call.

並移至下一張幻燈片並在該季度放大一點。您在我們的主要藥物中看到了相當一致的表現，我們將更詳細地介紹這一點。兩件事——我特別想提到的兩種產品。我認為 Kesimpta 有一個非常強勁的季度，展示了其作為多發性硬化症治療選擇的整體形象。 Kisqali 現在也在乳腺癌領域獲得了發展勢頭——在轉移性乳腺癌患者中，我們將在整個電話會議中更多地討論這一點。

Now moving to the next slide. We've really focused attention as a company on 6 key growth drivers, we believe, which will enable us to deliver the growth profile we've outlined both in the next 5 years and also beyond. Notably, Cosentyx and Entresto continued their outstanding performance towards their respective peak sales goal. We'll talk more about Zolgensma, which continues its global expansion. Kisqali and Kesimpta, I've already mentioned. And Leqvio, we are building a strong base with which we believe will enable this medicine to reach a significant sales potential over time. Taken together, these 6 brands now constitutes 32% of Innovative Medicine sales, and they're growing at 31%, I think giving confidence in the growth outlook that we've outlined.

現在轉到下一張幻燈片。作為一家公司，我們確實將注意力集中在 6 個關鍵增長驅動因素上，我們相信，這將使我們能夠在未來 5 年及以後實現我們所概述的增長概況。值得注意的是，Cosentyx 和 Entresto 繼續在各自的銷售高峰目標上表現出色。我們將更多地談論 Zolgensma，它繼續其全球擴張。我已經提到過 Kisqali 和 Kesimpta。而 Leqvio，我們正在建立一個強大的基礎，我們相信這將使該藥物隨著時間的推移達到顯著的銷售潛力。總的來說，這 6 個品牌現在佔創新藥物銷售額的 32%，並且以 31% 的速度增長，我認為這讓我們對我們概述的增長前景充滿信心。

Now moving to Slide 8 and going through each of these key brands, starting with Cosentyx. Cosentyx delivered sales 12% sales growth on the quarter. When you look at the outlook for Cosentyx, we continue to guide to a double-digit growth, driven by steady volume growth in the key geographies, U.S., Europe and China.

現在轉到幻燈片 8，並從 Cosentyx 開始瀏覽這些關鍵品牌中的每一個。 Cosentyx 在本季度實現了 12% 的銷售額增長。當您查看 Cosentyx 的前景時，在美國、歐洲和中國等主要地區的穩定銷量增長的推動下，我們將繼續實現兩位數的增長。

We're very confident in the overall clinical profile now that we've treated over 700,000 patients across 5 of the indications indicated for Cosentyx. And we continue to get important guideline recommendations, including the GRAPPA psoriatic arthritis guidelines, which highlight Cosentyx's unique benefit versus alternative therapies, including the IL-12/23s; and its ability to tackle axial manifestations of this disease.

既然我們已經在 Cosentyx 的 5 個適應症中治療了超過 700,000 名患者，我們對整體臨床概況非常有信心。我們繼續獲得重要的指南建議，包括 GRAPPA 銀屑病關節炎指南，其中強調了 Cosentyx 與包括 IL-12/23s 在內的替代療法相比的獨特優勢；及其解決這種疾病的軸向表現的能力。

Overall, we're confident in the $7 billion-plus peak sales potential. This will be driven by global expansion of the product as well as life-cycle management, where we had some good progress in the quarter, including approvals in pediatrics in Europe. We've submitted hidradenitis suppurativa in the EU, and we expect to submit in the U.S. in the second half. We have positive data on an IV study looking at Cosentyx use in axial spondyloarthritis. And lastly, we do anticipate an IV submission in the U.S. as well in psoriatic arthritis. Four proof points of our ongoing efforts on life-cycle management for Cosentyx.

總體而言，我們對超過 70 億美元的峰值銷售潛力充滿信心。這將受到產品全球擴張和生命週期管理的推動，我們在本季度取得了一些良好進展，包括歐洲兒科的批准。我們已經在歐盟提交了化膿性汗腺炎，我們預計下半年在美國提交。我們有一項關於 Cosentyx 在軸向脊柱關節炎中使用的 IV 研究的積極數據。最後，我們確實預計在美國以及銀屑病關節炎中提交靜脈注射。我們在 Cosentyx 生命週期管理方面的持續努力的四個證明點。

Then moving to the next slide, Slide 9. When you look at Entresto, Entresto is continuing its really dynamic growth globally. And in the U.S., you can see we delivered 33% growth with Entresto. Our weekly NBRx continues its strong progression with continued strong growth. We've now treated over 7 million patients globally and over 1 million patients in the U.S., growing in hospitals, cardiology and primary care. So really strong growth across geographies.

然後轉到下一張幻燈片，幻燈片 9。當您查看 Entresto 時，Entresto 在全球範圍內繼續其真正的動態增長。在美國，您可以看到我們使用 Entresto 實現了 33% 的增長。我們的每週 NBRx 繼續強勁增長，持續強勁增長。我們現在已經在全球治療了超過 700 萬患者，在美國治療了超過 100 萬患者，在醫院、心髒病學和初級保健領域不斷增長。跨地區的增長非常強勁。

And we're confident in the future growth and delivering the $5 billion-plus peak sales potential for this brand. There's only 1/3 of the addressable population that's been treated. And we see a strong profile consistently regardless of the setting the medicine is used in. And lastly, with the approval of Entresto in hypertension in Japan and China, where there's a high unmet need, it gives another opportunity for future growth.

我們對未來的增長充滿信心，並為該品牌帶來超過 50 億美元的峰值銷售潛力。只有 1/3 的可尋址人群得到了治療。無論在何種環境下使用該藥物，我們都始終看到強勁的形象。最後，隨著 Entresto 在日本和中國的高血壓治療中獲得批准，在這些地區有很高的未滿足需求，它為未來的增長提供了另一個機會。

Now moving to Slide 10 with Zolgensma. Zolgensma is continuing to demonstrate the power of a onetime gene therapy to treat really -- in a dramatic way, treat a terrible disease like SMA. 26% growth driven by global expansion, 2,300 patients now treated. We had recent reimbursement decisions, positive reimbursement decisions in Australia, Switzerland and Greece. And we recently received approval for our North Carolina new manufacturing facility, which further expands the capacity of our gene therapy network and really brings online the state of the art facility, continuing our leadership in the gene -- AAV gene therapy space.

現在與 Zolgensma 一起移至幻燈片 10。 Zolgensma 正在繼續展示一次性基因療法治療真正的力量——以一種戲劇性的方式，治療像 SMA 這樣的可怕疾病。全球擴張推動了 26% 的增長，目前有 2,300 名患者接受治療。我們最近做出了報銷決定，在澳大利亞、瑞士和希臘做出了積極的報銷決定。我們最近獲得了北卡羅來納州新製造設施的批准，這進一步擴大了我們基因治療網絡的能力，真正使最先進的設施上線，繼續我們在基因——AAV 基因治療領域的領導地位。

Now future growth drivers for Zolgensma are going to be that continued global expansion, 43 countries to date and growing. We also want to enable stronger newborn screening programs outside of the United States. 97% of newborns are screened in the U.S., but only 30% in Europe and those numbers are similar or lower in many other geographies. As we can get more newborns screened, then we believe Zolgensma is the treatment of choice for these babies, allows for normalization of their overall development.

現在，Zolgensma 未來的增長動力將是持續的全球擴張，迄今為止已在 43 個國家/地區不斷增長。我們還希望在美國以外的地區實施更強大的新生兒篩查計劃。 97% 的新生兒在美國接受篩查，但在歐洲只有 30%，而且在許多其他地區，這些數字相似或更低。由於我們可以對更多新生兒進行篩查，因此我們相信 Zolgensma 是這些嬰兒的首選治療方法，可以使他們的整體發育正常化。

And we saw that in a Nature publication that recently summarized the data from one of our earlier studies, with 14 out of 15 patients walking alone and 11 of them in the normal development window when treated early with Zolgensma. I also want to note that both our STEER studies and STRENGTH studies are progressing well. And we continue to outlook a submission in intrathecal for Zolgensma for 2- to 18-year olds in 2025.

我們在最近總結了我們一項早期研究的數據的 Nature 出版物中看到了這一點，在早期接受 Zolgensma 治療時，15 名患者中有 14 名獨自行走，其中 11 名處於正常發育窗口。我還想指出，我們的 STEER 研究和 STRENGTH 研究進展順利。我們繼續展望 2025 年為 2 至 18 歲的 Zolgensma 進行鞘內註射。

Then moving to the next slide with Kisqali. We continue to deliver double-digit growth, you see 43% growth. And we see this as a brand that, given its recent data releases, is really coming into a strong profile and a strong growth profile. We're seeing increased traction based on the clinical data. I'll talk more about that a little bit later in the presentation.

然後與 Kisqali 一起轉到下一張幻燈片。我們繼續實現兩位數的增長，您會看到 43% 的增長。我們認為這是一個品牌，鑑於其最近發布的數據，它確實具有強大的知名度和強勁的增長勢頭。根據臨床數據，我們看到了越來越大的吸引力。稍後我將在演示文稿中詳細討論這一點。

And we saw that, at ASCO, once again, we were able to highlight some of the data sets, particularly around OS in the first-line setting, which demonstrates the strong profile of Kisqali. The NATALEE adjuvant study, primary analysis is expected in 2023 and continues to progress on track. And I'll talk more about that in the pipeline section.

我們看到，在 ASCO 上，我們再次強調了一些數據集，尤其是在一線環境中圍繞 OS 的數據集，這證明了 Kisqali 的強大形象。 NATALEE 輔助研究、初步分析預計在 2023 年進行，並將繼續按計劃進行。我將在管道部分詳細討論這一點。

Now moving to Kesimpta on the next slide, Slide 12. The launch is continuing to -- and really continuing on a strong trajectory. We see an acceleration of the brand in the U.S., and we continue to work towards providing the medicine globally in our key markets. We have U.S. demand of 18% growth quarter-over-quarter. We have 3,200 adopters, physician adopters, since launch. You can see the NBRx up now 42%. It's really dynamic growth for this medicine.

現在移動到下一張幻燈片上的 Kesimpta，幻燈片 12。發布正在繼續 - 並且確實繼續沿著強勁的軌跡進行。我們看到該品牌在美國的加速發展，我們將繼續努力在我們的主要市場向全球提供藥物。我們的美國需求環比增長 18%。自推出以來，我們有 3,200 名採用者，即醫生採用者。您現在可以看到 NBRx 上漲了 42%。對於這種藥物來說，這是真正的動態增長。

And we're working to continue to strengthen the profile and differentiation. We have new extension data which demonstrated 8 out of 10 patients treated continuously with Kesimpta had no evidence of disease activity. From an operational standpoint, we continue to work to drive fast initiation. Patients are now getting on therapy within 6 days, 80% of patients are achieving that goal. And 77% of patients remain on therapy at 12 months, which I think, again, demonstrates the medicine's impact as well as its ease of use for patients. So very excited about the outlook for Kesimpta.

我們正在努力繼續加強形象和差異化。我們有新的擴展數據表明，連續接受 Kesimpta 治療的 10 名患者中有 8 名沒有疾病活動的證據。從運營的角度來看，我們將繼續努力推動快速啟動。患者現在可以在 6 天內接受治療，80% 的患者正在實現這一目標。 77% 的患者在 12 個月時仍在接受治療，我認為這再次證明了該藥物的影響以及它對患者的易用性。對 Kesimpta 的前景感到非常興奮。

Now moving to the next slide, on Slide 13. With Leqvio, we're laying the foundation, as we've outlined, in 2022, for the ramp we expect over the coming years. And we continue to expect the remainder of 2022 for a steady ramp-up of Leqvio. But I think there's important proof points that we're beginning to lay that groundwork successfully.

現在轉到下一張幻燈片，即幻燈片 13。通過 Leqvio，我們正在為 2022 年我們預計未來幾年的斜坡奠定基礎，正如我們所概述的那樣。我們繼續預計 2022 年剩餘時間 Leqvio 將穩步增長。但我認為有重要的證據表明我們已經開始成功地奠定基礎。

First, with respect to access. And as a reminder, Leqvio is under the medical benefit. We have 65% of patients now covered with -- aligned to our label or near our label, and that's within 6 months of launch. This is higher than relevant competitor brands, both from PCSK monoclonal antibodies and/or other recently launched anti-cholesterol therapeutics, and those brands have been in the market for many years. So I think that it demonstrates we've been able to drive fast access. And the J code now is in place as of July 1. So I think from an access perspective, we're progressing well, progressing on or ahead of our plan, and I think that sets us up well for the future.

首先，關於訪問。提醒一下，Leqvio 享受醫療福利。我們現在覆蓋了 65% 的患者——與我們的標籤一致或接近我們的標籤，這是在推出後的 6 個月內。這高於相關競爭品牌，無論是來自 PCSK 單克隆抗體和/或其他最近推出的抗膽固醇治療藥物，而且這些品牌已經上市多年。所以我認為這表明我們已經能夠推動快速訪問。 J 代碼現在已於 7 月 1 日到位。所以我認為從訪問的角度來看，我們進展順利，正在或超過我們的計劃，我認為這為我們的未來奠定了良好的基礎。

Secondly on affordability, we can now confirm the 2/3 of the patients have 0 co-pay for Leqvio, including Medicare Part D patients with supplemental insurance. This, again, we believe, will enable a strong uptake and strong adherence to this medicine so patients can get the benefit that they need from lower cholesterol.

其次，在可負擔性方面，我們現在可以確認 2/3 的患者對 Leqvio 的共付額為 0，包括有補充保險的 Medicare Part D 患者。我們再次相信，這將使該藥物的吸收和依從性強，因此患者可以從降低膽固醇中獲得所需的益處。

And lastly, we're making progress working through logistics and administration for this medicine in cardiologist offices as well as in relevant hospitals and medical centers. We've increased the number of unique locations ordering Leqvio to over 700. We're expanding the depth now with 55% of our customers already having placed repeat orders. And we're seeing growing usage now, with 2,100 HCPs and now 3,900 patients in the service center.

最後，我們正在心髒病專家辦公室以及相關醫院和醫療中心通過後勤和管理該藥物的工作取得進展。我們已將訂購 Leqvio 的獨特地點的數量增加到 700 多個。我們現在正在擴大深度，55% 的客戶已經重複訂購。我們現在看到使用量不斷增長，服務中心有 2,100 名 HCP，現在有 3,900 名患者。

So all of this taken together, I think, points to a strong future for the brand. And we'll continue to work through the second half of this year to build out this base to enable long-term growth.

因此，我認為，所有這一切都指向了該品牌的強勁未來。我們將在今年下半年繼續努力建立這個基礎以實現長期增長。

Then moving to the next slide, Slide 14, with Pluvicto. And moving to our 2 recently launched medicines in oncology, Pluvicto and Scemblix. The Pluvicto launch is really progressing in a strong manner, and it's either at or above our own expectations. We've seen our manufacturing issues remediated and we've cleared our backlog. Commercial and clinical supply resumed in June. We have a permanent A code that was granted in July and that will be effective in October. Over 50% of insured lives now are covered. We have over 100 RLT sites now operational, 40 sites have completed orders. So a strong trajectory from the start, and we're hoping to maintain that over the coming months.

然後移動到下一張幻燈片，幻燈片 14，使用 Pluvicto。並轉向我們最近推出的兩種腫瘤藥物，Pluvicto 和 Scemblix。 Pluvicto 的發布確實取得了強勁的進展，它達到或超過了我們自己的預期。我們已經看到我們的製造問題得到了補救，我們已經清除了我們的積壓。商業和臨床供應於 6 月恢復。我們有一個永久的 A 代碼，該代碼於 7 月授予，並將於 10 月生效。現在，超過 50% 的被保險人都得到了保障。我們現在有 100 多個 RLT 站點正在運營，40 個站點已完成訂單。所以從一開始就是一個強勁的軌跡，我們希望在接下來的幾個月裡保持這種軌跡。

We're preparing for further expansion with this medicine given the clinical profile we've seen to date. Both the Phase III studies are on track, both in the pre-taxane setting and the hormone-sensitive setting, with a readout for the pre-taxane study still slated for the -- before the end of this year.

鑑於我們迄今為止看到的臨床概況，我們正準備進一步擴展該藥物。兩項 III 期研究都在進行中，包括紫杉烷前環境和激素敏感環境，紫杉烷前研究的讀數仍定於今年年底之前。

The manufacturing scale-up is ongoing. We have a new facility in Indianapolis that we plan to bring online in the second half of next year, and we have capacity and our expansions ongoing in our Italy and New Jersey sites. And we're making significant investments to ensure logistics can support access, as the patient population that can be reached by radioligand therapies continue to expand across Pluvicto, Lutathera and our pipeline.

製造規模擴大正在進行中。我們在印第安納波利斯有一個新工廠，計劃在明年下半年上線，我們在意大利和新澤西的工廠擁有產能和正在進行擴張。我們正在進行大量投資，以確保物流能夠支持訪問，因為放射配體療法可以覆蓋的患者群體繼續在 Pluvicto、Lutathera 和我們的管道中擴大。

So moving to the next slide, Slide 15. Scemblix as well is off to a very strong U.S. launch. And then we achieved the, as I noted earlier, important regulatory milestones in the EU, $31 million of sales, primarily driven in that third-line setting. 44% share in the third line, which I think is a good marker given how recently we launched the medicine. And 16% NBRx share regardless of CML line of treatment.

所以轉到下一張幻燈片，幻燈片 15。Scemblix 也即將在美國推出非常強勁的產品。然後，正如我之前提到的，我們在歐盟實現了重要的監管里程碑，銷售額為 3100 萬美元，主要是在三線環境中推動的。第三行的份額為 44%，考慮到我們最近推出的藥物，我認為這是一個很好的標誌。無論 CML 治療線如何，16% 的 NBRx 份額。

In terms of future growth for Scemblix, it's going to be driven by the first-line study which is enrolling ahead of plan. Just as a reminder, it's versus investigator choice of TKI. And the CHMP positive opinion in the ex U.S. markets, where we continue to work to get a global rollout of the medicine.

就 Scemblix 的未來增長而言，它將由提前註冊的一線研究推動。提醒一下，TKI 與調查員的選擇不同。以及 CHMP 在美國以外市場的積極意見，我們將繼續努力在全球推廣該藥物。

So moving to the next slide and turning to Sandoz. As you saw, Sandoz had a really solid quarter in quarter 2. And we raised the full year guidance for Sandoz, and Harry will talk a little bit more about that. When you look at the drivers for Sandoz's sales performance, it's primarily in Europe, where we are a leader, the leading generics company, with 4% growth driven by both launches as well as recovery of the health care systems.

所以轉到下一張幻燈片並轉向 Sandoz。如您所見，Sandoz 在第二季度的表現非常穩健。我們提高了 Sandoz 的全年指導，Harry 將對此進行更多討論。當您查看山德士銷售業績的驅動因素時，主要是在歐洲，我們在歐洲處於領先地位，是領先的仿製藥公司，其推出和醫療保健系統的恢復推動了 4% 的增長。

We had double-digit growth in the rest of world markets, Japan and other emerging markets. And we've seen a stabilization in the U.S. business, setting us up with future biosimilars launches and small molecules launches to drive growth in the U.S. over the years to come. You can see our retail sales growth in the quarter was 4%, biopharma was up 11%, so we've raised the guidance as mentioned.

我們在世界其他市場、日本和其他新興市場實現了兩位數的增長。我們已經看到美國業務趨於穩定，為我們在未來幾年推出生物仿製藥和推出小分子藥物奠定了基礎，以推動美國未來幾年的增長。你可以看到我們本季度的零售額增長了 4%，生物製藥增長了 11%，所以我們已經提高了上述指導。

And when you look longer term, we believe this creates a solid base of growth -- for growth 2023 and beyond. And a lot of that will be driven by the biosimilars portfolio. The portfolio of biosimilars and Sandoz targets $80 billion of originator sales. Over 15 assets in the portfolio. And some recent progress, including the acceptance of the adalimumab high-concentration formulation as well as natalizumab in the EU.

從長遠來看，我們相信這會為 2023 年及以後的增長奠定堅實的增長基礎。其中很大一部分將由生物仿製藥產品組合推動。生物仿製藥和山德士的產品組合目標是 800 億美元的原始銷售。投資組合中超過 15 種資產。以及最近的一些進展，包括在歐盟接受阿達木單抗高濃度製劑以及那他珠單抗。

We're also continuing to pursue small molecule opportunities to bolster the small molecule portfolio. Overall, the strategic review for Sandoz is continuing to progress on track, and we expect an update at the latest by the end of this year.

我們還在繼續尋求小分子機會以支持小分子產品組合。總體而言，山德士的戰略審查正在繼續按計劃進行，我們預計最遲在今年年底前會有更新。

So moving to the next slide on Slide 17. Our broad pipeline of novel medicines progressed in quarter 2, but we've also worked to focus our efforts, as you saw in both our earnings release as well as with some of our pipeline decisions, 5 core therapeutic areas while being opportunistic in other therapeutic areas. And we're trying to make consequential decisions to really ensure we're focused and getting scale in those 5 core therapeutic areas.

所以轉到幻燈片 17 的下一張幻燈片。我們廣泛的新型藥物管道在第二季度取得了進展，但我們也努力集中精力，正如您在我們的收益發布和我們的一些管道決策中所看到的那樣， 5 個核心治療領域，同時在其他治療領域投機取巧。我們正在努力做出相應的決定，以真正確保我們專注於這 5 個核心治療領域並擴大規模。

On this slide, a few things to highlight. We had important designations in milestones, Scemblix, I've mentioned. Pelacarsen completed enrollment for the Phase III HORIZON study, so on track on its journey to become the first medicine to treat LTa-driven cardiovascular outcomes.

在這張幻燈片上，有幾件事要強調。我們在里程碑中指定了重要的名稱，Scemblix，我已經提到過。 Pelacarsen 完成了 III 期 HORIZON 研究的註冊，因此走上了成為第一個治療 LTa 驅動的心血管結果的藥物的旅程。

JDQ443, our G12C inhibitor for solid tumors. The Phase III study in second-, third-line non-small cell lung cancer was initiated, and we continue to also progress combination studies for that medicine.

JDQ443，我們的 G12C 實體瘤抑製劑。二線、三線非小細胞肺癌的 III 期研究已經啟動，我們還將繼續推進該藥物的聯合研究。

Cosentyx was filed -- had a filing for hidradenitis suppurativa in Europe, and we continue to work towards the U.S. filing.

Cosentyx 已提交——在歐洲提交了化膿性汗腺炎的申請，我們將繼續努力爭取美國的申請。

And then lastly, we continue to streamline the portfolio. We had a number of projects that we made the decision to either partner or stop. And notably, we're exiting our efforts -- development efforts in COPD and general asthma with the decision to partner 2 assets in that portfolio. And we'll continue to look to streamline the medicine portfolio in our pipeline so that we can focus on the medicines that matter most in our core therapeutic areas.

最後，我們繼續精簡產品組合。我們有許多項目，我們決定要么合作要么停止。值得注意的是，我們正在退出我們的努力——在 COPD 和一般哮喘方面的開發工作，並決定與該投資組合中的 2 項資產合作。我們將繼續尋求精簡我們管道中的藥物組合，以便我們可以專注於我們核心治療領域最重要的藥物。

So moving to Slide 18. I did want to say another word on Kisqali. Given the OS benefit now we've seen across all 3 of the Phase III trials in the metastatic setting we've conducted to date, on the left-hand side, you can see the results that we've generated in the first-line metastatic setting. You can see impressive risk reduction, and importantly, median OS that's been achieved consistently across these 3 studies, the longest median OS ever published. And we've seen that same OS benefit regardless of situation. We also maintain that benefit even after prior CDK4/6 use. So we think this data set is part of the reason we're seeing the real growth acceleration behind Kisqali.

所以轉到第 18 張幻燈片。我確實想對 Kisqali 再說一句話。鑑於我們在迄今為止進行的轉移性環境中的所有 3 項 III 期試驗中都看到了 OS 優勢，在左側，您可以看到我們在一線產生的結果轉移性設置。您可以看到令人印象深刻的風險降低，重要的是，在這 3 項研究中始終如一地實現了中位 OS，這是有史以來最長的中位 OS。無論情況如何，我們都看到了相同的操作系統優勢。即使在之前使用 CDK4/6 之後，我們也能保持這種優勢。所以我們認為這個數據集是我們看到 Kisqali 背後真正的增長加速的部分原因。

Now in the middle frame, you see the reason for this clinically, we believe, is that Kisqali is unique in its ability to hit the CDK4 target. And we hit it 8x harder than we hit CDK6. And that's relevant because we believe CDK4 is the key driver of the benefits you're seeing for this medicine. And you can see our relative performance versus -- in preclinical studies versus our competition.

現在在中間框架中，您會看到臨床上出現這種情況的原因，我們相信，Kisqali 在擊中 CDK4 目標的能力方面是獨一無二的。我們擊中它的難度是擊中 CDK6 的 8 倍。這很重要，因為我們相信 CDK4 是您看到這種藥物益處的關鍵驅動因素。您可以看到我們在臨床前研究與我們的競爭中的相對錶現。

Now when you look at the adjuvant study, it's fully enrolled, as we've already noted. We've already cleared the first futility analysis. The primary analysis is planned at 500 IDFS events, and we expect that by the end of 2023. The 2 interim analyses are to be conducted at 350 and 425 events. We have not yet reached the first of those interim analyses. We expect that in the coming quarters. We do guide for the study to really complete at the end of next year when we reach a full number of events. But we'll of course keep the market updated as we progress through these interim analyses.

現在，當您查看輔助研究時，正如我們已經指出的那樣，它已完全註冊。我們已經清除了第一個無效分析。主要分析計劃在 500 個 IDFS 事件上進行，我們預計到 2023 年底。2 個中期分析將在 350 和 425 個事件上進行。我們還沒有達到這些中期分析中的第一個。我們預計未來幾個季度會出現這種情況。我們會指導這項研究在明年年底完成所有活動時真正完成。但隨著這些中期分析的進展，我們當然會及時更新市場。

Then moving to the next slide on Slide 19. We're on track largely against our key 2022 events. Just 3 things to note. Three submission-enabling readouts coming up in the second half of this year: CANOPY-A; iptacopan in PNH; and as already mentioned, Pluvicto in the pre-taxane setting. So we'll look forward to those study readouts and updating all of you as we get that data in-house.

然後轉到幻燈片 19 的下一張幻燈片。我們在很大程度上正朝著 2022 年的關鍵事件前進。只需注意 3 件事。今年下半年將推出三個可提交的讀數：CANOPY-A； PNH中的iptacopan；如前所述，Pluvicto 在紫杉烷前環境中。因此，當我們在內部獲得這些數據時，我們將期待這些研究讀數並更新你們所有人。

So with that, I will hand it over to Harry.

所以有了這個，我會把它交給哈利。

Yes. Thank you very much, Vas. Good morning and good afternoon, everybody. 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.

是的。非常感謝你，瓦斯。大家早上好，下午好。我現在將向您介紹第二季度和上半年的一些財務狀況。和往常一樣，除非另有說明，否則我的評論指的是固定貨幣的增長率。

So on the next slide, yes, we show our quarter 2 and half 1 financial results summary. As you can see, quarter 2 sales and core operating income both grew 5% in constant currencies with sales benefiting from the continued strong performance of our key growth brands and core operating income growth driven mainly by the higher sales. However, operating income and net income declined significantly in the quarter. This was mainly due to prior year divestment gains from tail-end products and higher impairments and higher restructuring costs this quarter, mainly for the transformation for growth program.

所以在下一張幻燈片上，是的，我們展示了第二季度和第一季度的財務結果摘要。如您所見，按固定匯率計算，第二季度銷售額和核心營業收入均增長 5%，銷售額受益於我們主要增長品牌的持續強勁表現，而核心營業收入增長主要受銷售額增長的推動。然而，該季度的營業收入和淨收入顯著下降。這主要是由於去年尾端產品的剝離收益以及本季度更高的減值和更高的重組成本，主要是為了轉型增長計劃。

Core EPS grew 1%. However, if you exclude the impact of the prior year Roche income, core EPS would have grown 10%. Overall, we delivered solid sales and core operating income growth for the quarter, resulting also in a strong operational half 1 performance, with sales growing 5% and core operating income 7%. Core EPS in half 1 grew 11%, excluding the Roche stake impact.

核心每股收益增長 1%。但是，如果排除上一年羅氏收入的影響，核心每股收益將增長 10%。總體而言，我們在本季度實現了穩健的銷售和核心營業收入增長，也帶來了強勁的半年運營業績，銷售額增長 5%，核心營業收入增長 7%。上半年核心每股收益增長 11%，不包括羅氏股份的影響。

On the next slide, I would like to drill down a bit into the performance by division. So for quarter 2, you can see that Innovative Medicines top line grew 5% and the bottom line 6%, resulting an improvement in the core margin of 15 basis points to 37.2%. Sandoz net sales also grew 5%, although core operating income decreased 4%, mainly due to increased M&S investments and higher other expenses. This was reflected in the core margin, which decreased to 20.4%.

在下一張幻燈片上，我想按部門深入研究一下表現。因此，對於第 2 季度，您可以看到創新藥物的收入增長 5%，利潤增長 6%，導致核心利潤率提高 15 個基點至 37.2%。山德士的淨銷售額也增長了 5%，儘管核心營業收入下降了 4%，這主要是由於 M&S 投資增加和其他費用增加。這反映在核心利潤率上，下降至 20.4%。

Overall for the first half, we saw a strong performance for Innovative Medicines and Sandoz, Innovative Medicines sales growing 5% and core operating income 6% in half 1. Sandoz grew 6% on the top line and 10% on the bottom line in half 1, driven by a very strong quarter 1. And as a reminder, as we discussed in April, Sandoz benefited from a return towards normal business dynamics compared to a lower prior year base. Our half 1 core margin improved by 30 basis points for Innovative Medicines, 70 basis points for Sandoz and 60 basis points for the total group.

總體而言，上半年，我們看到創新藥物和山德士表現強勁，創新藥物銷售額增長 5%，核心營業收入增長 6% 1. 山德士上半年收入增長 6%，利潤增長 10% 1，由非常強勁的季度推動 1. 作為提醒，正如我們在 4 月所討論的，與去年較低的基數相比，山德士受益於恢復正常的業務動態。創新藥物的半 1 核心利潤率提高了 30 個基點，山德士提高了 70 個基點，整個集團提高了 60 個基點。

Turning now to our guidance on Slide 23. So within the divisions, we expect Innovative Medicines sales growing mid-single digit and core operating income growing mid- to high-single digit ahead of sales. The expected IM core margin increase will be driven by expected continued good top line momentum and continuation of our productivity programs, of course, including the new organizational structure giving us some benefits in the second half already.

現在轉向我們對幻燈片 23 的指導。因此，在各個部門中，我們預計創新藥物的銷售額將增長中個位數，核心營業收入將在銷售額之前增長中至高個位數。預期的 IM 核心利潤率增長將受到預期持續良好的收入勢頭和我們生產力計劃的繼續推動，當然，包括新的組織結構已經在下半年給我們帶來了一些好處。

For Sandoz, the performance year-to-date allows us to upgrade sales guidance to grow low single digit, which is a one-notch upgrade. And core operating income guidance is upgraded by 2 notches to now be broadly in line with the prior year.

對於山德士來說，年初至今的業績使我們能夠將銷售指導上調至低個位數增長，這是一個檔次的升級。核心營業收入指引上調了 2 個等級，現在與上一年基本持平。

For the group, we confirm our overall full year guidance. We continue to expect both top and bottom line to grow mid-single digit in 2022. The key assumption for this guidance is that we see a continuing return to normal global health care systems, including prescription dynamics, and that no Gilenya and no Sandostatin LAR generics would enter in the U.S. in 2022.

對於該集團，我們確認了我們的整體全年指導。我們繼續預計 2022 年的收入和利潤都將增長中個位數。本指南的關鍵假設是，我們看到全球醫療保健系統持續恢復正常，包括處方動態，並且沒有 Gilenya 和 Sandostatin LAR仿製藥將於 2022 年進入美國。

As many of you know, in June of this year, the U.S. Appeals Court held the Gilenya U.S. dosing regimen patent in ballot. We plan to petition the Appeals Court for further review to uphold validity of this patent. And as a reminder, there's no generic competition in the U.S. at this point in time. For Gilenya and in quarter 2, U.S. sales were $332 million for Gilenya. It is worth noting that U.S. Gilenya sales have been steadily declining due to competitive pressures and of course our key focus in [multiple sclerosis] being on Kesimpta.

眾所周知，今年 6 月，美國上訴法院對 Gilenya 美國給藥方案的專利進行了投票。我們計劃向上訴法院申請進一步審查以維持該專利的有效性。提醒一下，目前在美國沒有通用競爭。對於 Gilenya 和第二季度，Gilenya 在美國的銷售額為 3.32 億美元。值得注意的是，由於競爭壓力，美國 Gilenya 的銷售額一直在穩步下降，當然我們在 [多發性硬化症] 上的重點是 Kesimpta。

Next slide, please. I would like to provide some further details on the expectations for the second half dynamics on top and bottom line. We expect sales to continue to grow mid-single digits, bringing us to our guidance for the full year.

請下一張幻燈片。我想提供一些進一步的細節，說明對下半年動態的頂線和底線的預期。我們預計銷售額將繼續增長中個位數，使我們達到全年的指導水平。

For half 2 core operating income, we expect to grow slightly slower compared to half 1 at low to mid-single digits. This is mainly due to the higher prior year base for Sandoz in half 2. And as you know, half 1 core operating income growth benefited partly from the very low prior year base at Sandoz. We will of course continue to monitor the impacts of inflation and utility costs, particularly on the Sandoz product portfolio as well as the situation around COVID-related lockdowns in China given that we are seeing improving signs as of June, which we will continue to monitor in half 2.

對於半數 2 的核心營業收入，我們預計與半數 1 相比，其增長將略微放緩，處於中低個位數。這主要是由於山德士上年基數較高的一半 2。如您所知，半年 1 核心營業收入增長部分受益於山德士上年基數非常低。我們當然會繼續監測通貨膨脹和公用事業成本的影響，特別是對山德士產品組合的影響，以及中國與 COVID 相關的封鎖情況，因為截至 6 月我們看到了改善的跡象，我們將繼續監測在一半 2。

On the next slide, I would like to provide an update on our new simplified organization model and the financial impacts of the restructuring. As Vas discussed earlier, we have increased our estimate of SG&A savings to approximately $1.5 billion. We anticipate the savings to be fully embedded by 2024. This year, we also expect some savings, but the overall impact will be minimal as we will be offsetting higher energy cost and inflationary pressures.

在下一張幻燈片中，我想介紹一下我們新的簡化組織模型以及重組的財務影響。正如 Vas 之前所討論的，我們已將 SG&A 節省的估計增加到約 15 億美元。我們預計到 2024 年將完全節省成本。今年，我們也預計會節省一些成本，但總體影響將微乎其微，因為我們將抵消更高的能源成本和通脹壓力。

Part of the $1.5 billion savings, we expect to be reinvested into our pipeline, and a significant part will contribute to achieve our mid- to long-term low 40s Innovative Medicines' core margin guidance. With regards to the onetime restructuring costs, we could narrow this range a bit, and we estimate this now to be onetime to 1.2x of the annual structure savings of $1.5 billion.

在節省的 15 億美元中，我們預計將再投資到我們的管道中，其中很大一部分將有助於實現我們的中長期低 40 年代創新藥物的核心利潤率指導。關於一次性重組成本，我們可以稍微縮小這個範圍，我們現在估計這一次是每年結構節省 15 億美元的 1.2 倍。

On Slide 26, I want to provide an update on expected currency impact if currencies stay at the current levels. Obviously, currency impacts are significant this year given the strengthening U.S. dollar against many currencies. So if currencies stay as they are now, for the full year, we estimate the impact on top line to be negative 6 to 7 percent points; and on the bottom line, negative 7 to 8 percent points.

在幻燈片 26 上，如果貨幣保持在當前水平，我想提供有關預期貨幣影響的最新信息。顯然，鑑於美元兌多種貨幣走強，今年的貨幣影響顯著。因此，如果貨幣保持現狀，全年，我們估計對收入的影響為負 6 至 7 個百分點；最重要的是，負 7 到 8 個百分點。

And given it's volatile, we wanted to give you also a bit of an outlook for 2023. So for the full year in 2023, we would expect sales to be impacted by negative 2% and core operating income, negative 2% to 3% in 2023 versus 2022. As a reminder, we update these currency impacts on our website monthly. And I think, especially in these times, it's quite important to watch that.

鑑於它的波動性，我們還想給您一些 2023 年的展望。因此，對於 2023 年的全年，我們預計銷售額將受到 2% 的負數和核心營業收入的影響，即負 2% 至 3% 2023 年與 2022 年的對比。提醒一下，我們每月都會在我們的網站上更新這些貨幣影響。而且我認為，尤其是在這些時候，觀看這一點非常重要。

Finally, on Page #27. Thank you. Finally, a reminder about our capital allocation priorities where we remain disciplined and shareholder-focused, of course. We aim to balance investing in the business with returning capital to shareholders via our dividend and share buybacks.

最後，在第 27 頁。謝謝你。最後，提醒一下我們的資本分配優先事項，當然，我們仍然保持紀律和以股東為中心。我們的目標是通過股息和股票回購在業務投資與向股東返還資本之間取得平衡。

In the first half, our investment in the organic business was $4.5 billion in R&D and $0.5 billion in CapEx. We also had bolt-on M&A, which was around $0.9 billion, mainly for the Gyroscope acquisition.

上半年，我們對有機業務的研發投資為 45 億美元，資本支出為 5 億美元。我們還進行了追加併購，金額約為 9 億美元，主要用於收購 Gyroscope。

Alongside this, as you can see, in terms of returning capital to shareholders, we paid our annual dividend of $7.5 billion earlier this year and have $9.4 billion still to be executed of our ongoing $15 billion share buyback program, of which, we have completed $5.6 billion by the end of June.

除此之外，正如您所看到的，在向股東返還資本方面，我們今年早些時候支付了 75 億美元的年度股息，我們正在進行的 150 億美元股票回購計劃仍有 94 億美元有待執行，其中，我們已經完成到 6 月底達到 56 億美元。

And with that, I hand it back to Vas.

有了這個，我把它交還給 Vas。

Thank you, Harry. So if we move to the last slide, Slide 29. We continue to progress against our top 2022 priorities as we've outlined. Successful launches, particularly ensuring the foundation is laid for Leqvio, but driving the dynamic performance of Kesimpta, Pluvicto and Scemblix, which as you've seen, are continuing apace.

謝謝你，哈利。因此，如果我們轉到最後一張幻燈片，即第 29 張幻燈片。我們將繼續按照我們概述的 2022 年的首要任務取得進展。成功發布，特別是確保為 Leqvio 奠定基礎，但推動 Kesimpta、Pluvicto 和 Scemblix 的動態性能，正如您所見，它們正在繼續快速發展。

Maintaining the growth momentum across our 6 key in-line growth drivers. Progressing the pipeline, where we have 20-plus assets where we expect significant sales potential with approval potential by 2026 and the pipeline is on track. We're tracking well on our Sandoz review and with a solid quarter from Sandoz in quarter 2. We'll keep you updated as we move towards an update before the end of 2022 at the latest.

在我們的 6 個關鍵在線增長驅動因素中保持增長勢頭。推進管道，我們擁有 20 多項資產，我們預計到 2026 年有巨大的銷售潛力和批准潛力，並且管道正在走上正軌。我們在 Sandoz 的審查中跟踪良好，第二季度 Sandoz 的季度業績穩定。我們將在最遲於 2022 年底之前進行更新時為您提供最新信息。

And we remain disciplined in our business development, looking for important opportunities to build out our pipeline, but remaining disciplined with how we allocate our capital, continuing to deliver our returns. And you've seen that with our productivity initiatives, our increase to $1.5 billion of SG&A savings with our new organizational model. And we continue to reinforce the foundations we believe that, in the long run, will drive Novartis' performance around culture; data science; and as I noted earlier, ESG.

我們在業務發展中保持自律，尋找建立管道的重要機會，但在我們如何分配資本方面保持自律，繼續提供我們的回報。您已經看到，通過我們的生產力計劃，我們通過新的組織模式節省了 15 億美元的 SG&A。我們將繼續鞏固我們認為從長遠來看將推動諾華圍繞文化表現的基礎；數據科學；正如我之前提到的，ESG。

So with that, we look forward to taking your questions. (Operator Instructions) So operator, we can open the line for questions.

因此，我們期待著回答您的問題。 （操作員說明）所以操作員，我們可以打開線路提問。

(Operator Instructions) We will now take our first question from Matthew Weston from Credit Suisse.

（操作員說明）我們現在將回答來自瑞士信貸的 Matthew Weston 的第一個問題。

A question on Kisqali, please, Vas. And you were -- very clearly set out the interim analysis timelines and the final analysis time line. One question that we've received a lot in recent weeks is how you would communicate when you go past an interim. Would you consider that a material event, which you have to press release to the market? Obviously, if it's positive, it would be positive and we'd see a release. But if you simply pass an interim and move forward, would you see that as requiring a press release? Or would we simply learn that at the next quarter, where you would update the timelines?

Vas，請提一個關於 Kisqali 的問題。你是 - 非常清楚地列出了中期分析時間表和最終分析時間表。最近幾週我們收到的一個問題是，當你過了一個過渡期時，你將如何溝通。您是否認為這是一個重要事件，您必須向市場發布新聞稿？顯然，如果它是積極的，那就是積極的，我們會看到發布。但是，如果你只是簡單地通過一個過渡期並繼續前進，你會認為這需要新聞稿嗎？或者我們會在下個季度簡單地了解您將在哪裡更新時間表？

Yes. Thanks, Matthew. So I think as you outlined, clearly, if at any time in the study that we either get a definitive positive result as determined by the DSMB, or a negative result, we would update the market. Otherwise, our plan would be, at the quarterly call, to provide updates on where we stand on the study. We don't believe passing an interim analysis warrants any sort of further update.

是的。謝謝，馬修。因此，我認為正如您所概述的那樣，如果在研究中的任何時候，我們要么得到 DSMB 確定的明確的積極結果，要么得到否定的結果，我們將更新市場。否則，我們的計劃將是在季度電話會議上提供我們在研究中的立場的最新信息。我們認為通過中期分析不需要任何形式的進一步更新。

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

您的下一個問題來自 Wolfe Research 的 Tim Anderson。

Just a high-level question on health care reform. And just talk of reconciliation pushing ahead, it seems like it's finally going to happen, to us at least. Your thoughts on the likelihood of this happening and what it could mean to industry financials and to Novartis specifically over time. And if you have certain products that you think would be impacted the most.

只是一個關於醫療改革的高級問題。只是談論推進和解，似乎它最終會發生，至少對我們來說。您對這種情況發生的可能性的看法，以及隨著時間的推移它對行業財務和諾華的影響。如果您有某些您認為受影響最大的產品。

Yes. Thanks, Tim. I think as everyone is reading in the press, there is renewed momentum behind a reconciliation package, which would consist of a drug pricing reform and supporting ACA subsidies. Of course, our overall view remains that there are good and bad elements to the package.

是的。謝謝，蒂姆。我認為，正如每個人都在媒體上閱讀的那樣，和解方案背後有新的動力，其中包括藥品定價改革和支持 ACA 補貼。當然，我們的總體觀點仍然是包裝有好的和壞的元素。

Clearly, Part D reform is needed. The fact capping out of patient out-of-pockets will be, I think, a positive step, enable patients to refill their prescriptions and also enable, in our -- from our sector, demand to be supported.

顯然，需要進行 D 部分改革。我認為，從患者的自付費用中扣除上限將是一個積極的步驟，使患者能夠重新填寫他們的處方，並在我們的部門中支持需求。

But of course, there are onerous elements as well which we think go too far and don't support long-term innovation, will have detrimental effects to the long-term outlook for the industry, particularly the negotiation elements.

但當然，也有一些繁重的因素，我們認為走得太遠，不支持長期創新，會對行業的長期前景產生不利影響，尤其是談判因素。

Now from Novartis specifically, we view these as not significant impacts in the near to midterm. We've analyzed this quite in a detailed manner. I mean, I think as is well known, we're the #1 company, pharmaceutical company in Europe and a leader in many emerging markets. Our business in the U.S. is one we plan to grow significantly over time. But our relative exposure to the peer set in terms of both government programs and over U.S. -- overall U.S. sales is at the low end of the peer set. So we would expect to have a far lower effect than our -- impact on us relative to our peers. And so I would say, in the near to midterm, not a significant impact overall, net of the positives we get from the Part D reform and of course the impact from inflation caps as well as negotiations. That's how we see it at the moment. But of course, we'll continue to analyze as the final bill text is available.

現在，特別是諾華，我們認為這些在近期和中期不會產生重大影響。我們已經非常詳細地分析了這一點。我的意思是，眾所周知，我們是歐洲排名第一的製藥公司和許多新興市場的領導者。我們在美國的業務是我們計劃隨著時間的推移顯著增長的業務。但就政府項目和美國而言，我們與同行的相對風險敞口——美國的整體銷售額處於同行的低端。因此，相對於我們的同行，我們預計對我們的影響遠低於我們的影響。所以我想說，在近期和中期，總體上不會產生重大影響，扣除我們從 D 部分改革中獲得的積極因素，當然還有通脹上限和談判的影響。這就是我們目前的看法。但是，當然，隨著最終的法案文本可用，我們將繼續分析。

Your next question comes from the line of Richard Vosser from JPMorgan.

您的下一個問題來自摩根大通的 Richard Vosser。

Are you on mute? As there is no response from Richard, I will go to the next...

你靜音了嗎？由於理查德沒有回應，我會去下一個......

Sorry, apologies. Completely my fault. Just on Kisqali, if you can hear me now. Just wanted to go back to the growth potential in the first-line opportunity. And how much of the Ibrance market you think you can take with the OS benefit? Obviously, we can see Verzenio benefiting as well, but just your thoughts there.

對不起，道歉。完全是我的錯。就在 Kisqali，如果你現在能聽到我的話。只是想回到一線機會的增長潛力。您認為您可以利用操作系統優勢在 Ibrance 市場中佔據多少份額？顯然，我們可以看到 Verzenio 也從中受益，但只是您的想法。

Yes. Thanks, Richard. With Kisqali, we're starting to see a positive trend on NBRx in the first half of the year versus the competition in the metastatic setting. And that comes primarily from Ibrance. And I think that's reflective of the data set that we have in OS, as I've outlined. It's important to note as well in many European and ex U.S. markets, we are either #1 or close to #1, depending on the market. And we can, we believe, drive additional momentum in those ex U.S. markets as well. So I think it's positive signs.

是的。謝謝，理查德。有了 Kisqali，我們開始看到今年上半年 NBRx 的積極趨勢與轉移性環境中的競爭相比。這主要來自 Ibrance。正如我所概述的，我認為這反映了我們在操作系統中擁有的數據集。值得注意的是，在許多歐洲和美國以外的市場中，我們要么排名第一，要么接近排名第一，具體取決於市場。我們相信，我們也可以在美國以外的市場推動額外的發展勢頭。所以我認為這是積極的跡象。

We want to see that trend continue for hopefully a couple more quarters, particularly given that now the dynamic market within breast cancer is starting to recover. I would note that it's just recently on our data coming back to where it was pre-COVID, which again is an opportunity for us to gain share as there's an opportunity to get either new patients or switching patients onto Kisqali. So I think it's all positive directions, and we'll see how the trend goes in the coming months.

我們希望看到這種趨勢持續幾個季度，特別是考慮到現在乳腺癌的動態市場開始復蘇。我要指出的是，最近我們的數據才恢復到 COVID 之前的狀態，這再次是我們獲得份額的機會，因為有機會獲得新患者或將患者轉移到 Kisqali。所以我認為這都是積極的方向，我們將看看未來幾個月的趨勢如何。

Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank.

您的下一個問題來自德意志銀行的 Emmanuel Papadakis。

Perhaps I'll take one on Sandoz, please. As you called out, biosimilars clearly the key to returning to reasonable levels of growth in the midterm. You recently filed the biosimilar HUMIRA, Hyrimoz high-dose in Europe. Could you just give us an update on where you are with respect to the U.S. for that opportunity, i.e., both as regard to high-dose filing and potential interchangeability? And how significant an opportunity you think that may be for business, and indeed, whether that would have any influence on your considerations on strategic options.

也許我會在 Sandoz 上拿一個，拜託。正如您所說，生物仿製藥顯然是在中期恢復合理增長水平的關鍵。您最近在歐洲提交了生物仿製藥 HUMIRA、Hyrimoz 高劑量。您能否向我們介紹一下您在美國獲得該機會的最新情況，即在高劑量申請和潛在互換性方面？以及您認為這對企業來說有多麼重要的機會，實際上，這是否會對您對戰略選擇的考慮產生任何影響。

Yes. Thanks, Emmanuel. So we're on track overall to be launching HUMIRA, the adalimumab biosimilar at market formation in the U.S., and it's our intention to have the high-concentration formulation available. I think as soon as we have a file accepted by FDA, would of course put out a release and update the market. So I would say, overall, we're on track with respect to that.

是的。謝謝，伊曼紐爾。因此，我們總體上正在按計劃推出 HUMIRA，這是一種在美國市場形成的阿達木單抗生物仿製藥，我們打算提供高濃度製劑。我認為一旦我們獲得 FDA 接受的文件，當然會發布並更新市場。所以我想說，總的來說，我們在這方面走上了正軌。

I think clearly, the number of entrants when the adalimumab market formation happens will mean that it will be a highly competitive market set. But nonetheless, given the size of the opportunity, it will help meaningfully drive growth for the brand.

我清楚地認為，當阿達木單抗市場形成時進入者的數量將意味著它將是一個競爭激烈的市場集。但儘管如此，鑑於機會的規模，它將有助於推動品牌的有意義的增長。

I would also note that natalizumab, where we are one of the early entrants, is a significant opportunity for Sandoz. And I think natalizumab both in the U.S. and Europe is one we're excited about as an opportunity to drive growth within the next few years. And the other upcoming opportunity for us is denosumab, where again, I think we would be one of the earlier entrants amongst biosimilars players.

我還要指出，那他珠單抗，我們是早期進入者之一，對山德士來說是一個重要的機會。我認為那他珠單抗在美國和歐洲都是我們興奮的一個機會，可以在未來幾年內推動增長。對我們來說，另一個即將到來的機會是狄諾塞麥，我認為我們將再次成為生物仿製藥廠商中較早進入者之一。

But those would be the 3 key upcoming biosimilar launches for Sandoz and particularly in the U.S.

但這將是 Sandoz 即將推出的 3 個關鍵的生物仿製藥，尤其是在美國。

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

您的下一個問題來自美國銀行的 Graham Parry。

I'm just going a little on NATALEE, actually. So I think at the Q1 files, you said you were at 300 events. So I wonder if you could give us an update on how many events you're at in the trial.

實際上，我只是稍微介紹一下 NATALEE。所以我認為在第一季度的文件中，你說你參加了 300 場活動。所以我想知道您是否可以向我們提供有關您在試驗中參加了多少活動的最新信息。

And is that the sort of event rate, as it sits, that you still have a couple of months delay before the DMC reports to you what the outcome of those interims are?

在 DMC 向您報告這些臨時措施的結果之前，您是否還有幾個月的延遲？

And in the event you were to get positive data, to what extent can you put subgroup analysis, et cetera, in the press release? So whether you've hit across all subgroups, high-risk low risk, et cetera. Just what would be in the press release would just be quite interesting to know.

如果您要獲得積極的數據，您可以在多大程度上將亞組分析等放在新聞稿中？因此，無論您是否觸及所有亞組、高風險低風險等等。知道新聞稿中的內容會很有趣。

Yes. Thanks, Graham. On Kisqali, obviously don't want to get into what exactly the number of events are. I would say the event rate that we've seen -- and as we noted previously, we had a slower event rate than we had originally projected and that event rate has continued. So there's no change in the overall event rate.

是的。謝謝，格雷厄姆。在 Kisqali 上，顯然不想了解確切的事件數量。我想說的是我們已經看到的事件發生率——正如我們之前提到的，我們的事件發生率比我們最初預計的要慢，而且事件發生率還在繼續。所以總體事件率沒有變化。

I would also note that you are correct that, from the point of a lock, it does take a few months to get the readout with the DMC. And particularly because we work with one of the large CROs in the U.S. as part of the study. So that's, I think, important to note from a time line standpoint.

我還要注意，您是正確的，從鎖定的角度來看，使用 DMC 獲得讀數確實需要幾個月的時間。特別是因為作為研究的一部分，我們與美國的一家大型 CRO 合作。我認為，從時間線的角度來看，這很重要。

In terms of what's in the release. I mean, I think we typically would only comment on the primary endpoint. And in this case, that's the IDFS across both the medium- and high-risk patient populations. We wouldn't, of course, get into subgroups.

就版本中的內容而言。我的意思是，我認為我們通常只會對主要終點發表評論。在這種情況下，這就是中高風險患者群體的 IDFS。當然，我們不會進入子組。

I would also note that the DMC's primary basis for stopping the study would be IDFS. We would hopefully see in the OS trend, but I think that's an important note as well. I would expect that -- as would be the case normally in such an oncology study, OS takes more time to mature. And of course, we'll have to see how it all unfolds over the coming quarters.

我還要指出，DMC 停止研究的主要依據是 IDFS。我們希望看到操作系統的趨勢，但我認為這也是一個重要的注意事項。我希望——就像在這樣的腫瘤學研究中通常的情況一樣，操作系統需要更多時間才能成熟。當然，我們將不得不看看這一切在接下來的幾個季度中會如何展開。

Your next question comes from the line of Yukie Aizawa from Cowen.

您的下一個問題來自 Cowen 的 Yukie Aizawa。

Can you hear me?

你能聽到我嗎？

Yes.

是的。

This is Steve Scala. On remibrutinib, is there any sign of liver tox similar to Sanofi's tolebrutinib? And is there any reason to believe that liver tox is a class effect?

這是史蒂夫·斯卡拉。在瑞布替尼上，是否有任何類似於賽諾菲的託來替尼的肝毒性跡象？有沒有理由相信肝毒是一種階級效應？

Yes. Thanks, Steve. We've been watching this space very closely. I mean, when you look overall at BTK inhibitors in cancer historically, liver has not been a signal, at least to our knowledge, that's been a significant concern. And also BTK is not differentially expressed within liver. So in our view, this is related to the drug itself, either metabolites or off-target toxicities in the liver.

是的。謝謝，史蒂夫。我們一直在密切關注這個空間。我的意思是，當你從歷史上看 BTK 抑製劑在癌症中的整體情況時，肝臟並不是一個信號，至少據我們所知，這是一個重要的問題。而且 BTK 在肝臟中也沒有差異表達。所以在我們看來，這與藥物本身有關，無論是代謝物還是肝臟中的脫靶毒性。

To date with remibrutinib, we haven't seen any liver signals. We've taken it forward into chronic spontaneous urticaria as its first lead indication, where there are 2 pivotal Phase IIIs ongoing. And then similarly, now are progressing in our MS studies; and also evaluating taking the medicine into other areas of rheumatology, dermatology, et cetera.

迄今為止，使用瑞布替尼，我們還沒有看到任何肝臟信號。我們已將其納入慢性自發性蕁麻疹作為其第一個主要適應症，其中有 2 個關鍵的 III 期正在進行中。然後類似地，現在我們的 MS 研究正在取得進展；並評估將藥物用於風濕病學、皮膚病學等其他領域。

Our hope and expectation is that the profile of remibrutinib continues to be clean relative to the peer set, particularly with respect to liver signals. We believe that, in the MS market, but also in the dermatology market, it's going to be critical to have a medicine that has a safe profile with -- especially with respect to more complex side effects like liver.

我們的希望和期望是，相對於同行而言，瑞布替尼的概況繼續保持清潔，特別是在肝臟信號方面。我們相信，在 MS 市場以及皮膚病學市場中，擁有一種具有安全特性的藥物至關重要——尤其是對於肝臟等更複雜的副作用。

So that's where we stand, and we remain optimistic on that unique profile of remibrutinib based on its chemical design and the lack of any off-target toxicities seen to date.

這就是我們的立場，我們仍然對瑞布替尼的獨特特徵持樂觀態度，因為它的化學設計和迄今為止沒有發現任何脫靶毒性。

Your next question comes from Florent Cespedes from Societe Generale.

您的下一個問題來自法國興業銀行的 Florent Cespedes。

A quick one on Kesimpta. Could you elaborate a bit on how do you see the dynamic on the ex U.S. sales? They are still quite small for the time being but are ramping up nicely. Could you give us what should boost the sales here?

一個關於 Kesimpta 的快速報告。您能否詳細說明您如何看待前美國銷售的動態？它們暫時仍然很小，但正在迅速增長。你能告訴我們什麼可以促進這裡的銷售嗎？

Yes. Thank you, Florent. With respect to Kesimpta, already, we covered the U.S. at length. I mean, we're starting to now move through, as you know, the longer reimbursement processes that were required in Europe, Canada and other global markets. So we would expect to see in the second half, and then moving into next year, more significant sales contributions from our ex U.S. markets.

是的。謝謝你，弗洛倫特。關於 Kesimpta，我們已經詳細介紹了美國。我的意思是，如您所知，我們現在開始經歷歐洲、加拿大和其他全球市場所需的更長報銷流程。因此，我們預計在下半年，然後進入明年，我們的前美國市場的銷售貢獻將更加顯著。

Of course, the big market's in Europe, but I was also recently in Canada, where there's a lot of excitement as well about the medicine. And then to a lesser extent, in Asia, Japan, et cetera, where MS rates are lower, but the market sizes are significant.

當然，大市場在歐洲，但我最近也在加拿大，那裡也有很多關於藥物的興奮。然後在較小程度上，在亞洲、日本等，MS 率較低，但市場規模很大。

I mean, I think it's important to note in those markets, a monthly subcu patient-administered drug is very attractive because out of those markets, they're not the same incentive structures around infused medicines, as well as the ability to deload the hospital system by having at-home administration.

我的意思是，我認為在這些市場中需要注意的是，每月一次由患者服用的 subcu 藥物非常有吸引力，因為在這些市場之外，它們與輸液藥物的激勵結構不同，以及使醫院減負的能力通過在家管理系統。

So we feel optimistic about the opportunity now for Kesimpta as its next wave of growth to really be about a global expansion of the medicine.

因此，我們對 Kesimpta 現在的機會感到樂觀，因為它的下一波增長真正是關於藥物的全球擴張。

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 Emily Field。

I just want to ask a question on the development plans for ligelizumab. I believe kind of the slides just mentioned food allergy. But on clinicaltrials.gov, the [plural provoke] study in CINDU still looks to be recruiting. So just any update on the other indications.

我只是想問一個關於ligelizumab的發展計劃的問題。我相信剛才提到食物過敏的幻燈片。但在clinicaltrials.gov 上，CINDU 的[複數挑釁] 研究看起來仍在招募中。所以只是其他跡象的任何更新。

Yes. With ligelizumab, as you know, we made the decision not to take it forward in NCSU. But we continue the development program in seafood allergy and we'll complete the program as well in CINDU. And we continue to believe the medicine has potential in some of these indications where IgE inhibition has demonstrated the ability to impact asymptomatic disease as well as disease progression.

是的。如您所知，使用 ligelizumab，我們決定不在 NCSU 推進它。但是我們繼續海鮮過敏的開發計劃，我們也將在 CINDU 完成該計劃。我們繼續相信該藥物在 IgE 抑制已證明能夠影響無症狀疾病和疾病進展的某些適應症中具有潛力。

So we still think the medicine has potential, particularly in food allergy, where if we could find the right setting for its use and get a relatively broad label from the regulators, it would have a significant potential. So those development programs continue on track, and we would expect the readouts as we note in our documentation.

所以我們仍然認為這種藥物有潛力，特別是在食物過敏方面，如果我們能找到合適的使用環境，並從監管機構那裡獲得相對廣泛的標籤，它就會有很大的潛力。因此，這些開發計劃繼續走上正軌，我們希望得到我們在文檔中提到的讀數。

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。

A quick 2-part product question, if I may, please. Firstly on Zolgensma. Vas, you talked about the strong ex U.S. growth, but actually, the growth in the U.S. was pretty impressive this quarter. I just wondering if there's anything to add behind that.

如果可以的話，請提供一個由兩部分組成的快速產品問題。首先是關於 Zolgensma。 Vas，您談到了強勁的前美國增長，但實際上，本季度美國的增長令人印象深刻。我只是想知道這背後是否有什麼要補充的。

And secondly on Leqvio. I wonder if you could update us on the ex U.S. performance, particularly the U.K.

其次是 Leqvio。我想知道您能否向我們介紹前美國的表現，尤其是英國的表現。

Yes. With respect to Zolgensma, we were pleased as well to see the performance in the U.S. That's primarily driven by expansion in newborn screening, where -- you'll remember, when we launched the medicine, we were down to 60%, 70%, and now we're moving into the mid- to high 90s.

是的。關於 Zolgensma，我們也很高興看到美國的表現。這主要是由新生兒篩查的擴張推動的，你會記得，當我們推出這種藥物時，我們下降到 60%、70%、現在我們正在進入 90 年代中期至高端。

And as we get that newborn screening rate up, it tends to be the case that patients who are identified in newborn screening ultimately receive Zolgensma. And so I think that will continue as we move up the newborn screening. But then of course we would expect that to be back to a steady state. As with all gene therapies, eventually, you get to the steady state of the ability to identify the diseases at birth in a so-called incident population.

隨著新生兒篩查率的提高，在新生兒篩查中發現的患者最終會接受 Zolgensma。因此，我認為隨著我們提高新生兒篩查水平，這種情況將繼續下去。但當然，我們希望這會恢復到穩定狀態。與所有基因療法一樣，最終，您可以在所謂的事件人群中實現在出生時識別疾病的能力的穩定狀態。

When you look at the specifics on Leqvio ex U.S., I'd say in the U.K. as well, we've been systematically building up towards what we hope will be a trend break. I think the U.K. NHS had to of course deal with COVID for much of the first part of this year.

當您查看美國前 Leqvio 的具體情況時，我會說在英國也是如此，我們一直在系統地建立我們希望成為趨勢突破的目標。我認為英國 NHS 當然必須在今年上半年的大部分時間里處理 COVID。

In the last few months, we've now successfully upgraded and enabled NHS EHRs identify patients who would be able to use Leqvio. We have now I think over 70% of primary health care units with Leqvio available on their formularies. We've launched a large-scale education campaign in the U.K. So I would expect to see as well, hopefully, a trend break in Leqvio the U.K. and in the first part of next year as we continue to build that foundation in the second half, and as the NHS works through the backlog it has from other -- from other diseases because of the COVID pandemic.

在過去的幾個月中，我們現已成功升級並啟用 NHS EHR，以識別能夠使用 Leqvio 的患者。現在，我認為超過 70% 的初級衛生保健單位的處方集上都有 Leqvio。我們已經在英國發起了一場大規模的教育活動。所以我也希望看到 Leqvio 在英國和明年上半年的趨勢突破，因為我們將在下半年繼續建立這一基礎，並且當 NHS 處理由於 COVID 大流行而導致的其他疾病的積壓工作時。

Beyond that, we see a very strong uptake in Germany with Leqvio. On a per population basis, the uptake is very good. We've assigned successfully large-scale agreements with certain Middle East governments to roll out Leqvio at scale in those markets. And then we also continue to work to bring Leqvio forward in the large markets of Japan and also are finalizing the plan for filing in China as well.

除此之外，我們看到 Leqvio 在德國的應用非常強勁。按人口計算，吸收率非常好。我們已經成功地與某些中東政府簽訂了大規模協議，以便在這些市場大規模推出 Leqvio。然後，我們還將繼續努力將 Leqvio 推向日本的大型市場，同時也在敲定在中國的備案計劃。

But I'd say all of that is going -- of course, again, as always, with cardiovascular launches, it takes time. But on this one, I mean, absolutely, our goal is to ramp this medicine faster than we were able to in Entresto. And obviously, with a runway that goes to the late 2030s at the very least, the significant opportunity to make this a really, really significant medicine.

但我想說所有這一切都在進行——當然，再一次，一如既往，隨著心血管的啟動，這需要時間。但在這一點上，我的意思是，絕對地，我們的目標是比我們在 Entresto 中能夠更快地增加這種藥物。顯然，至少要到 2030 年代後期才能有一條跑道，這是使它成為一種非常非常重要的藥物的重要機會。

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。

Focusing on radioligand therapies and the recent manufacturing delays. Can you now confirm that you -- do you outsourced supply for running an inventory building for both Lutathera and Pluvicto?

專注於放射配體療法和最近的製造延遲。您現在能否確認您是否外包供應以運行 Lutathera 和 Pluvicto 的庫存建設？

I wonder if you can also elaborate on your plans for expansion of RLT manufacturing supply going forward and how you work around what you've learned through those recent delays.

我想知道您是否還可以詳細說明您未來擴大 RLT 製造供應的計劃，以及您如何解決您從最近的延誤中學到的東西。

And is there any risk with the recent manufacturing gap to result in a delay to the ongoing Phase III PSMAfore study? Which I think is due by year-end.

最近的製造差距是否存在導致正在進行的 III 期 PSMAfore 研究延遲的風險？我認為應該在年底之前完成。

Yes. Thanks, Kerry. So a couple of points on radioligand therapy manufacturing, which is a challenge, but also I think points to why, if we can get it right, creates a long-term competitive advantage.

是的。謝謝，克里。因此，關於放射配體治療製造的幾點意見，這是一個挑戰，但我認為也指出了為什麼，如果我們能做對，創造長期的競爭優勢。

This is a medicine where you cannot build inventory. We make the medicine, and depending on whether it's Lutathera or Pluvicto, we have between 3 and 5 days to get it to its relevant site. And so because of that, you have to be world-class with respect to the supply chain. And it's not something easy, I think, for anyone to build from scratch.

這是一種無法建立庫存的藥物。我們製造藥物，根據是 Lutathera 還是 Pluvicto，我們有 3 到 5 天的時間將其送到相關網站。因此，您必須在供應鏈方面處於世界一流水平。我認為，對於任何人來說，從頭開始構建都不是一件容易的事。

What we've learned is to increase capacity with redundant lines and different manufacturing sites to enable us to ensure we have a steady supply if we were to have a disruption at any one of our sites. And within those sites, to segregate the lines, so that the one line having an issue doesn't affect any of the other lines. And we've been able to do that now at the relevant sites, particularly in our Italian site and in our U.S. site.

我們學到的是通過冗餘生產線和不同的製造地點來增加產能，以確保我們在任何一個地點出現中斷時都能確保我們有穩定的供應。在這些站點中，隔離線路，以便有問題的線路不會影響任何其他線路。我們現在已經能夠在相關網站上做到這一點，特別是在我們的意大利網站和我們的美國網站。

So with all of that being said, we've cleared the backlog. We are now shipping to order successfully. We're also, with large centers, moving to a model where we provide Pluvicto doses ahead, even if they don't have patients ready yet, so that the supply is there. And of course, that enables them to book additional patients with confidence.

綜上所述，我們已經清除了積壓工作。我們現在正在成功發貨。我們還擁有大型中心，轉向我們提前提供 Pluvicto 劑量的模式，即使他們還沒有準備好患者，所以供應就在那裡。當然，這使他們能夠放心地預訂更多患者。

And then to further expand the supply, we'll be bringing on a third large-scale manufacturing facility in Indianapolis. That will actually have automated lines, moving away from more manual lines, which just further increases capacity. So we would expect, by mid- to second half of next year, to have 3 separate U.S. manufacturing facilities to support the U.S. for both Lutathera and Pluvicto, giving us the redundancy, large-scale capacity and of course the ability then to fulfill what we hope, if the data supports it, a potential multibillion-dollar opportunity for Pluvicto across lines of prostate cancer.

然後為了進一步擴大供應，我們將在印第安納波利斯建立第三個大型製造工廠。這實際上將擁有自動化生產線，遠離更多的人工生產線，這只會進一步增加產能。因此，我們預計，到明年中下半年，將擁有 3 個獨立的美國製造工廠，為 Lutathera 和 Pluvicto 提供支持，為我們提供冗餘、大規模產能，當然還有能力實現如果數據支持，我們希望 Pluvicto 有潛在的數十億美元的機會跨越前列腺癌。

And I'd also take the opportunity to say that the feedback both from the nuclear radiology community as well as the urology community, which is an important customer base for this medicine, has been very positive to date.

我還想藉此機會說，核放射學界以及泌尿學界（該藥物的重要客戶群）的反饋迄今為止都非常積極。

With respect to the Phase III studies, we've been able to fully reopen enrollment. And we currently forecast is no change in time line, either for the pre-taxane study, which is slated to read out before the end of this year or the hormone-sensitive study, which is slated to read out in 2024. So both of those studies now are on track and, if anything, are enrolling slightly ahead of schedule.

關於 III 期研究，我們已經能夠完全重新開放招生。而且我們目前預測，無論是計劃在今年年底前公佈的紫杉烷前研究還是計劃於 2024 年公佈的激素敏感研究，時間線都不會發生變化。所以兩者這些研究現在正在按計劃進行，如果有的話，註冊人數會稍微提前。

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。

Great. Just one quick question on iptacopan. Vas, just wanted to get your thoughts on relative positioning in PNH and aHUS versus the well-established C5 inhibitors. Just wanted to get your sense of the ability to compete in the treatment-naive setting as well as the sort of patients that are struggling as we look at this first data set, and then I think the treatment-naive data set will come in the first half of next year.

偉大的。只是一個關於 iptacopan 的快速問題。 Vas，只是想了解您對 PNH 和 aHUS 與成熟的 C5 抑製劑的相對定位的看法。只是想讓您了解在未經治療的環境中競爭的能力以及在我們查看第一個數據集時正在苦苦掙扎的那種患者，然後我認為未經治療的數據集將出現在明年上半年。

Yes. Thanks, Seamus. We've done a lot of work with the U.S. team here and really to understand the physician expectations and the dynamics. And overall, we believe that hematologists would be highly interested in iptacopan, both in the first-line setting and for patients who are not receiving -- achieving an adequate response to the anti-C5 monoclonals.

是的。謝謝，西莫。我們在這裡與美國團隊做了很多工作，真正了解醫生的期望和動態。總體而言，我們相信血液學家會對 iptacopan 非常感興趣，無論是在一線環境中還是對於未接受治療的患者，都能對抗 C5 單克隆藥物產生足夠的反應。

I think unlike some of the other areas where a [Part D] infused medicine can create a barrier, this is a low-enough volume situation where we believe that patient ease of use to avoid having to come in and out of the hospital, also very safe drug that can be used across lines of therapy, would be highly attractive for physicians.

我認為與 [D 部分] 注入藥物會造成障礙的其他一些領域不同，這是一種足夠低的容量情況，我們認為患者易於使用以避免進出醫院，也可以跨治療線使用的非常安全的藥物，對醫生非常有吸引力。

So you're correct. The first data set will be focused both on add-on therapy as well as switch. And then we'll have a second data set, the PNH APPLY study, which would then be in the frontline setting. And those 2 data sets together will support the overall filing. So we remain optimistic on that PNH. And that, of course, will translate as well into atypical hemolytic-uremic syndrome in that setting.

所以你是對的。第一個數據集將側重於附加治療和轉換。然後我們將有第二個數據集，即 PNH APPLY 研究，然後將其置於一線環境中。這兩個數據集一起將支持整體歸檔。因此，我們對該 PNH 保持樂觀。當然，在這種情況下，這也會轉化為非典型溶血性尿毒症綜合徵。

I'd also note that the opportunity for -- hopefully, everyone on the call is aware for iptacopan is not only in that hematology setting, but we also prepare in the renal setting, where this could be the first medicine approved for C3G, glomerulopathies, as well as an opportunity to treat patients on the severe end of the spectrum with IgA nephropathy. And then we continue to expand across a range of other Factor B-driven diseases. And the unique profile here is it's a twice-a-day oral with a very, very safe safety profile, which I think, for these rare diseases, will hopefully make a lot of sense.

我還要指出，希望通話中的每個人都知道 iptacopan 的機會不僅在血液學環境中，而且我們還在腎臟環境中做準備，這可能是第一個被批准用於 C3G、腎小球病的藥物，以及治療嚴重 IgA 腎病患者的機會。然後我們繼續擴展一系列其他因子 B 驅動的疾病。這裡的獨特之處在於它是每天兩次的口服藥物，具有非常非常安全的安全性，我認為，對於這些罕見的疾病，這將有很大的意義。

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 Andrew Baum。

A question on your BeiGene collaboration, a couple of parts. So first, I'm curious whether you could provide some color on the FDA's guidance for you not to file in monotherapy. I assume that they have Western data, I think they do. So I'm just curious as to why. Is it because they feel the market's well served? Site inspections or some other?

關於您與百濟神州合作的問題，分為幾部分。所以首先，我很好奇你是否可以為 FDA 的指導提供一些顏色，讓你不要申請單一療法。我認為他們有西方數據，我認為他們有。所以我只是好奇為什麼。是因為他們覺得市場很好嗎？實地考察還是其他？

And then second, you have an option on the BeiGene TIGIT. It sounds like Roche is now not going to be presenting the interim data at ESMO. When do you have to exercise that option? And can you give us any guidance on what you will do given the available data?

其次，您可以選擇百濟神州 TIGIT。聽起來羅氏現在不會在 ESMO 上展示臨時數據。您何時必須行使該選擇權？鑑於現有數據，您能給我們任何指導嗎？

Yes. Thanks, Andrew. On the first question on monotherapy, I think the FDA's assessment of our overall data set was that it didn't adequately reflect the U.S. population in terms of the number of patients and the standard of care that was used in that BeiGene-driven first-line study.

是的。謝謝，安德魯。關於單一療法的第一個問題，我認為 FDA 對我們整體數據集的評估是，它沒有充分反映美國人口的患者數量和在百濟神州驅動的首次使用的護理標準——線學習。

So our focus right now is to finish the filing in the second-line small cell lung cancer -- sorry, esophageal cancer. And then we had very good data in the first-line setting as well. As we announced, that's been pushed back as we await the ability for FDA to inspect the facilities in China. And then hopefully, we'd be able to have both first and second line in esophageal, we'd have then hopefully second line in non-small cell lung cancer, and we would expand from there.

所以我們現在的重點是完成二線小細胞肺癌的備案——對不起，食道癌。然後我們在一線設置中也有非常好的數據。正如我們宣布的那樣，由於我們等待 FDA 檢查中國設施的能力，這已被推遲。然後希望我們能夠在食道中同時擁有一線和二線，然後我們希望在非小細胞肺癌中擁有二線，並且我們將從那裡擴展。

I do think that the FDA is making it very clear now that they expect a -- any studies to be filed, that they're global in nature, they have an appropriate amount of U.S. patients, and that the standard of care used reflects standard of care in the U.S.

我確實認為 FDA 現在已經明確表示，他們希望提交任何研究，它們是全球性的，他們有適當數量的美國患者，並且使用的護理標準反映了標準在美國的護理

With respect to the anti-TIGIT, we haven't changed -- no change from our option agreement. The option agreement is driven off of the data from ociperlimab, the BeiGene anti-TIGIT molecule. And so that option would be based on when their data set becomes available. And we'll continue to wait for that, their data to mature, which we would expect, I think, if I'm not mistaken, but we can verify in the second half of the -- first or second half of next year.

關於反 TIGIT，我們沒有改變——我們的期權協議沒有改變。期權協議是基於來自百濟神州抗 TIGIT 分子 ociperlimab 的數據。因此，該選項將基於他們的數據集何時可用。我們將繼續等待，他們的數據成熟，我認為，如果我沒記錯的話，我們會期待，但我們可以在明年上半年或下半年進行驗證。

Now in terms of the Roche data set, I mean, it doesn't change anything for us. We'll continue to wait and watch as the field evolves and then make an appropriate decision. I think it's important that we -- everyone would like to understand where is the appropriate use of this medicine, and in which PD-1 subgroup? All comers? And if there is a place, which place would it actually be? But for us, there's no change to plan at this point in time.

現在就羅氏數據集而言，我的意思是，它對我們沒有任何改變。我們將繼續等待和觀察該領域的發展，然後做出適當的決定。我認為重要的是我們——每個人都想了解這種藥物的適當用途，以及在哪個 PD-1 亞組中？都來了？如果有一個地方，它實際上會是哪個地方？但對我們來說，目前計劃沒有任何變化。

Your next question comes from the line of Laura Sutcliffe from UBS.

您的下一個問題來自瑞銀的 Laura Sutcliffe。

Could you help us understand who the typical U.S. prescriber of Leqvio is? Who's already prescribing to multiple patients? Or who is already a repeat prescriber?

您能否幫助我們了解典型的美國 Leqvio 處方者是誰？誰已經在給多名患者開藥了？或者誰已經是重複處方者？

Yes. Thanks, Laura. I spent -- it's a great question. I've spent 3 days now in the field here in the U.S. meeting clinicians, visiting hospital centers, visiting larger cardiology centers. I'd say right now, where we see the strongest uptake are in group cardiology practices, where they already have the ability to run buy and bill, they make their own decisions on how they want to approach treating for cholesterol, and have, I think, the infrastructure largely set up and also the scale.

是的。謝謝，勞拉。我花了 - 這是一個很好的問題。我現在在美國的現場待了 3 天，會見臨床醫生，參觀醫院中心，參觀更大的心髒病學中心。我現在想說的是，我們看到最強烈的吸收是在團體心髒病學實踐中，他們已經有能力進行購買和計費，他們自己決定他們想要如何治療膽固醇，並且有，我想想看，基礎設施基本上建立起來了，而且規模也很大。

So I'd say group cardiology, mid- to large-sized group cardiology practices, have been really, I think, a key area so far for the medicine. Combined with, I would say, large-volume cardiologists and smaller practices who are leveraging alternative injection centers, where we continue to see solid uptake. And that's a solid base for us to grow from.

所以我想說，團體心髒病學，中大型團體心髒病學實踐，我認為，到目前為止，它確實是醫學的一個關鍵領域。我想說，再加上大量心髒病專家和利用替代注射中心的小型診所，我們繼續看到這些中心的穩固吸收。這是我們成長的堅實基礎。

Now the goal is to move into larger centers where you of course have to work through the pharmacy and the various P&T committees to get everything set up. There now the J code being in place and the overall clinical experience increasing is helping. And then also moving towards smaller cardiology offices, where there is the need to set up buy-and-bill capabilities, which historically, have not been in place for those cardiology offices.

現在的目標是搬到更大的中心，當然你必須通過藥房和各種 P&T 委員會來完成所有工作。現在 J 代碼已經到位，整體臨床經驗的增加正在提供幫助。然後還轉向較小的心髒病科辦公室，在那裡需要建立購買和賬單功能，而這些能力在歷史上還沒有為這些心髒病科辦公室提供。

What I would say, though, is what I consistently hear regardless, and I think our teams here on the ground, is a lot of enthusiasm for a twice-a-year physician-administered medicine that can modify the single most important risk factor in cardiologists' mind for preventing repeat cardiology events, cardiovascular events.

不過，我想說的是，無論如何，我一直聽到的，而且我認為我們的團隊對一年兩次的醫師給藥藥物充滿熱情，這種藥物可以改變一個最重要的風險因素心髒病專家防止重複心髒病事件，心血管事件的想法。

And I think seeing that and hearing that again and again gives us confidence, gives me confidence, that we will work through the logistical hurdles, which seems to be the primary topic, and then get this medicine into wide-scale use.

我認為，一次又一次地看到和聽到這一點給了我們信心，給了我信心，我們將克服後勤障礙，這似乎是主要話題，然後讓這種藥物得到廣泛使用。

I think we often hear back from practices, especially when they put the patient on the medicine, and then at the next visit, they see a significant drop in the LDL levels, that's a very winning proposition after a single dose. And then I think those practices get really excited about getting more patients on therapy.

我認為我們經常聽到實踐的反饋，尤其是當他們給患者服用藥物時，然後在下一次就診時，他們看到 LDL 水平顯著下降，這是單次給藥後非常成功的主張。然後我認為這些做法對讓更多患者接受治療感到非常興奮。

So again, laying all the foundations, but I think all the right steps are being taken to get us to where we need to be.

再說一遍，奠定所有基礎，但我認為正在採取所有正確的步驟來讓我們到達我們需要的地方。

Your next question comes from the line of Keyur Parekh from GS.

您的下一個問題來自 GS 的 Keyur Parekh。

Vas, a big picture kind of capital allocation question for you. If we look at Slide 27, kind of first half, obviously, it's only first half, which shows that you kind of returned somewhere about $13 billion kind of to shareholders versus investing kind of about $6 billion in businesses and your kind of organic and bolt-on transactions.

Vas，對你來說是一個宏觀的資本分配問題。如果我們看一下幻燈片 27，很明顯，這只是上半年，這表明你向股東返還了大約 130 億美元，而不是在企業和你的有機和螺栓上投資了大約 60 億美元-on 交易。

As we look forward to the next kind of 12 to 18 months, do you expect that balance to be somewhat similar to what we have seen in the first half? Do you expect that to be more counterbalanced by greater investments, either from an R&D or an M&A perspective for Novartis?

當我們期待下一個 12 到 18 個月時，您是否認為這種平衡會與我們在上半年看到的有些相似？從諾華的研發或併購的角度來看，您是否希望通過更大的投資來平衡這一點？

And then just kind of more specifically, you were telling us that you'll provide us an update on Sandoz by the end of the year. What is that update expected to be? Are we going to get a decision on what you would do? Is it going to be, if you plan to separate it, we will we get details on structuring of separation, et cetera? So just any color you might be able to provide on what that detail or what the update might involve.

然後更具體地說，您告訴我們您將在今年年底前向我們提供有關 Sandoz 的最新信息。預期的更新是什麼？我們會決定你會做什麼嗎？如果您打算將其分離，我們是否會獲得有關分離結構等的詳細信息？因此，您可以提供任何顏色來說明該細節或更新可能涉及的內容。

Yes. Thanks, Keyur. So I'll let Harry start and then I can add on. Harry?

是的。謝謝，凱爾。所以我會讓哈利開始，然後我可以補充。哈利？

Yes. Thank you, Keyur. So on the capital allocation, of course, the whole thing is a bit skewed by our dividend being an annual dividend, right, at $7.5 billion. So if you want to do it mathematically, you almost have to half that and put it on 2 sides. But it's an annual dividend.

是的。謝謝你，凱爾。因此，當然，在資本分配方面，我們的股息是年度股息，對，75 億美元，整個事情有點扭曲。因此，如果您想以數學方式進行計算，則幾乎必須將其減半並將其放在兩側。但這是年度股息。

Overall, of course, all of these elements, R&D, we expect to continue to grow in line with sales at least. And so there will be continued growth on R&D investments. And we don't expect margin leverage from the R&D line as we go forward, more from the SG&A line where also our transformation for growth program is targeted at and where we have some gap to benchmarks and we can -- we have found some structural opportunities, which is great.

總的來說，當然，所有這些要素，研發，我們預計至少會隨著銷售額的增長而繼續增長。因此，研發投資將持續增長。而且，隨著我們的前進，我們預計研發線不會產生利潤率槓桿，更多來自 SG&A 線，我們的增長計劃轉型也是針對該線的，我們與基準有一些差距，我們可以——我們發現了一些結構性的機會，這很好。

And then in terms of how much it goes to bolt-on M&A, that obviously depends on the opportunities we find. And given our very attractive net debt position and strong cash flows and balance sheet, of course, we have quite significant bolt-on M&A firepower, if you will. And if we don't find the right opportunities, of course, share buybacks will always continue to be part of the mix.

然後就附加併購的金額而言，這顯然取決於我們發現的機會。鑑於我們非常有吸引力的淨債務狀況以及強勁的現金流和資產負債表，當然，如果你願意的話，我們擁有相當強大的併購火力。當然，如果我們找不到合適的機會，股票回購將始終是其中的一部分。

In terms of Sandoz, I think you said it all. We make very good progress in line with our plans on the carve-out financials, on looking at all different options. So would be, of course, happy to give a preliminary decision by end of year. But this is, of course, subject to Board approval and from that -- and the progress overall on our whole planning.

就 Sandoz 而言，我想你已經說了這麼多。在考慮所有不同的選擇時，我們在拆分財務方面的計劃取得了非常好的進展。當然，很高興在年底前做出初步決定。但這當然需要得到董事會的批准，以及我們整個計劃的整體進展情況。

But end of year should be quite -- giving you some good hints to what direction it goes, given that we take appropriate time for all the homework we are doing on the carve-out financial, separation cost, tax situations and all of that. So it would be -- think end of year later, we should be in a good position to inform you about the next steps here. Vas?

但是年底應該是相當的 - 給你一些很好的暗示它的發展方向，因為我們需要適當的時間來完成我們正在做的關於剝離財務、分離成本、稅收情況和所有這些方面的所有作業。所以它會 - 想想年底之後，我們應該可以很好地通知你這裡的下一步。瓦斯？

No, that's perfect. I think harry said it all. Thanks, Harry.

不，那是完美的。我想哈利說的都說了。謝謝，哈利。

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

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

Some of the work we've done suggests that people costs are around 40% to 50% of the total cost of the industry. And so my question is how we should think about the timing on the -- of the inflationary impact on salaries? Is it fair to assume that on the whole 2022 salaries and, therefore your guidance, has factored in only last year's inflation? And that really, we have to wait until next year's salary rounds before we start to see this year's inflation baked into your cost base on the salary side?

我們所做的一些工作表明，人員成本約佔行業總成本的 40% 到 50%。所以我的問題是我們應該如何考慮通貨膨脹對工資影響的時機？假設整個 2022 年的工資以及您的指導僅考慮了去年的通貨膨脹，這是否公平？真的，我們必須等到明年的薪水輪次才能開始看到今年的通貨膨脹已經影響到你在薪水方面的成本基礎？

Thank you, Naresh. Harry, do you want to take that?

謝謝你，納雷什。哈利，你想拿那個嗎？

Yes. You're absolutely right. I mean, the current inflationary effects, mainly on energy, utilities, freight costs and so on, those cost categories as we speak. On wages and salaries, not much yet, if anything. So that needs to be closely monitored. And I would expect this to come more in annual cycles.

是的。你是絕對正確的。我的意思是，當前的通脹效應，主要是對能源、公用事業、貨運成本等，我們所說的這些成本類別。關於工資和薪水，如果有的話，還不算多。所以需要密切關注。我希望這會在年度週期中出現更多。

If there is something short term, it's probably depending on certain countries. Of course, we always monitor the markets to be very competitive. And we have, of course, quite a big, if you will, workforce in Switzerland where inflation and wage increases are below, I would say, developed market average. So from that standpoint, our home base gives us also here a bit of a competitive advantage.

如果有短期的東西，它可能取決於某些國家。當然，我們始終監控市場，使其具有很強的競爭力。當然，如果你願意的話，我們在瑞士擁有相當大的勞動力，那裡的通貨膨脹和工資增長低於，我想說，發達市場的平均水平。所以從這個角度來看，我們的大本營也給了我們一些競爭優勢。

But we have to watch it, right? As you say, the wage and salaries are a large portion of the P&L of any pharma company, given its innovation-driven and people-intensive business. And we have to watch that and we'll monitor this, of course. I would say we believe it is manageable for us, but we have to monitor how the situation develops.

但我們必須觀察它，對吧？正如您所說，鑑於其創新驅動和人員密集型業務，工資和薪水是任何製藥公司損益的很大一部分。我們必須注意這一點，當然，我們會監控這一點。我想說我們相信這對我們來說是可控的，但我們必須監控情況的發展。

Your next question comes from the line of Sarita Kapila from Morgan Stanley.

您的下一個問題來自摩根士丹利的 Sarita Kapila。

Please, could you discuss where you stand on the development of the diabetes and obesity franchise? So you have the MBL949 in Phase II. I don't believe the mechanism has been disclosed, but it appears to be dosed every 2 weeks. And you also have an existing cardiovascular and metabolic commercial platform. And there are a number of assets focused on diabesity in Phase I/II, which remain unpartnered. So it looks like from today's update, respiratory is less of a focus. But it's not necessarily clear where you stand on diabesity and adding assets around Entresto, Leqvio and TQJ.

拜託，你能談談你對糖尿病和肥胖症專營權發展的立場嗎？所以你有第二階段的MBL949。我不相信該機制已被披露，但似乎每 2 週給藥一次。而且您還擁有一個現有的心血管和代謝商業平台。在 I/II 階段有許多專注於糖尿病的資產，這些資產仍然沒有合作。因此，從今天的更新看來，呼吸不再是重點。但不一定清楚你對糖尿病和在 Entresto、Leqvio 和 TQJ 周圍增加資產的立場。

Yes. Thanks for the question, and noted the Morgan Stanley report as well on obesity. Yes, I mean, I think we of course are observing the significant unmet need for better obesity medicines. And because we do have a dedicated cardiovascular research unit in-house led by Shaun Coughlin, really, I think a global leader in the thinking on developing world-class cardiometabolic drugs, we do have assets in our portfolio.

是的。感謝您的提問，並註意到摩根士丹利的肥胖報告。是的，我的意思是，我認為我們當然正在觀察對更好的肥胖藥物的巨大未滿足需求。而且因為我們確實有一個由 Shaun Coughlin 領導的內部心血管研究部門，我認為真的是在開發世界級心臟代謝藥物方面的全球領導者，我們的投資組合中確實有資產。

We have not disclosed MBL, but we are awaiting our Phase II data on weight loss with MBL. And if that's positive, that would be an exciting opportunity to hopefully address, with a unique mechanism of action, obesity on a large scale. And I think based on that readout, we would determine if we advance other earlier-stage opportunities and combination partners we would have for MBL as well as potential external opportunities.

我們尚未披露 MBL，但我們正在等待我們關於 MBL 減肥的 II 期數據。如果這是積極的，那將是一個令人興奮的機會，有望通過獨特的作用機制大規模解決肥胖問題。我認為，根據該讀數，我們將確定是否推進其他早期階段的機會和我們將為 MBL 擁有的聯合合作夥伴以及潛在的外部機會。

So I think more to come. Certainly observing the need for better obesity drugs and hopefully alternative mechanisms to those already out there. It's something we're looking at, and we'll keep the market up to date as we learn more.

所以我想更多。當然觀察對更好的肥胖藥物的需求，並希望替代已經存在的藥物機制。這是我們正在研究的東西，隨著我們了解更多信息，我們將及時更新市場。

Your next question comes from Peter Welford from Jefferies.

您的下一個問題來自 Jefferies 的 Peter Welford。

A question on Cosentyx, please. You've talked a little bit about the aims for this year. Wondering if you could just talk a little bit about next year.

請教一個關於 Cosentyx 的問題。你已經談到了今年的目標。想知道你是否可以談談明年的事情。

And in particular, you've also talked a lot about HUMIRA biosimilars in your plan there in the U.S. Can you just talk a little bit about how you see coverage negotiations for Cosentyx next year?

特別是，您在美國的計劃中也談到了很多關於 HUMIRA 生物仿製藥的內容。您能否談談您如何看待明年 Cosentyx 的覆蓋範圍談判？

And perhaps you could just talk about the impact of HS, which I guess is unlikely to be approved for the negotiating cycle this time around. But IV, on the other hand, also available, and how you think that fits into the potential patient access dynamics for Cosentyx going into next year.

也許你可以談談 HS 的影響，我想這一次不太可能被批准進入談判週期。但另一方面，IV 也可用，您認為這與 Cosentyx 進入明年的潛在患者訪問動態相適應。

Yes. Thanks, Peter. I mean, I think right now, our assessment is that with the introduction of adalimumab biosimilars, that it's a manageable situation. I mean, we already have significant gross to nets on Cosentyx in some accounts. In other accounts, we have very strong overall positioning and as a first-line therapy.

是的。謝謝，彼得。我的意思是，我認為現在，我們的評估是，隨著阿達木單抗生物仿製藥的引入，這是一個可控的情況。我的意思是，在某些賬戶中，我們已經在 Cosentyx 上獲得了可觀的總淨額。在其他方面，我們有非常強大的整體定位和一線治療。

And of course, we'll have to see as the upcoming year unfolds and also how some of the upcoming legislation that potentially might be passed by Congress will impact the gross to net environment, given that there would be, if the law passed as currently designed, less ability to offset increased rebates with price increases, I think there is a possibility we see a rethink on rebating at least on the industry side on how the whole structure of the market works. It's all to be determined and to be seen.

當然，我們將不得不看到，隨著即將到來的一年的展開，以及國會可能通過的一些即將通過的立法將如何影響總淨環境，如果法律按照目前的方式通過的話，將會有設計，通過價格上漲來抵消增加的回扣的能力較低，我認為我們有可能看到至少在行業方面對整個市場結構如何運作的回扣進行重新思考。這一切都有待確定和觀察。

I mean, I think for us strategically on Cosentyx in the U.S., the goal is, within rheumatology and dermatology to grow with the market and you see healthy market growth in both of those categories. And as you point out, expand both in terms of indications. We would hope to get hidradenitis approved over the course of next year, which then means, in 2024, it would be an additional labeled indication for us and a unique labeled indication for Cosentyx.

我的意思是，我認為對於我們在美國 Cosentyx 的戰略性研究，目標是在風濕病學和皮膚病學中隨著市場的發展而增長，並且您會看到這兩個類別的市場都在健康增長。正如您所指出的，在適應症方面進行擴展。我們希望在明年獲得汗腺炎批准，這意味著到 2024 年，這將是我們的一個額外的標記適應症，也是 Cosentyx 的一個獨特的標記適應症。

But also to expand into -- with IV into other payment settings and to have IV approved, hopefully, across both axial SpA as well as psoriatic arthritis would enable providers to also provide Cosentyx in those reimbursement settings. And hopefully, that also helps us manage the overall payer environment.

但也可以擴展到 - 將 IV 擴展到其他支付設置，並希望在軸向 SpA 和銀屑病關節炎中獲得 IV 批准，這將使供應商也能夠在這些報銷設置中提供 Cosentyx。希望這也有助於我們管理整個付款人環境。

It's probably the best answer I can give at this point in time. But I think as we learn more in the second half of the year, as we enter towards the January negotiations in Q4, we'll keep you posted.

這可能是我目前能給出的最佳答案。但我認為，隨著我們在下半年了解更多，隨著我們在第四季度進入 1 月份的談判，我們會及時通知您。

Your next question is from the line of Matthew Weston from Credit Suisse.

您的下一個問題來自瑞士信貸的 Matthew Weston。

Just a couple of follow-on housekeeping items, please. Harry, the quarter, we saw a significantly lower finance charges and also significantly lower corporate costs than consensus was anticipating. I note there was a hyperinflationary write-back in the finance charge. Can you give us any help with what we should anticipate for both those lines for the full year?

請提供一些後續的家政服務。哈里，本季度，我們看到財務費用顯著降低，企業成本也顯著低於共識預期。我注意到財務費用中存在惡性通貨膨脹。您能否就我們對這兩條線全年的預期提供任何幫助？

And then if I can cheat and ask another question. Vas, you obviously deemphasized COPD within development. Does that mean that we can anticipate that you may consider divesting your legacy respiratory assets? Or that's something where you're going to maintain an existing commercial franchise?

然後如果我可以作弊並問另一個問題。 Vas，您顯然在開發過程中不再強調 COPD。這是否意味著我們可以預期您可能會考慮剝離您遺留的呼吸資產？或者這就是你要維持現有商業特許經營權的地方？

Harry?

哈利？

Yes. Matthew, welcome to the second round. So on the corporate cost, we guided so far to $600 million to $650 million this year. Our new guidance now would be a notch down, $550 million to $600 million.

是的。馬修，歡迎來到第二輪。因此，在公司成本方面，我們今年迄今指導為 6 億至 6.5 億美元。我們現在的新指引將下調一個檔次，從 5.5 億美元降至 6 億美元。

Now the biggest piece of that is actually currency because, as you can imagine, given our headquarters in Switzerland, most of our corporate costs are in Swiss francs. And the Swiss francs also weakened versus the dollar. So the corporate dollars, if you will, will be a little bit less and will be a bit lower.

現在其中最大的部分實際上是貨幣，因為您可以想像，鑑於我們在瑞士的總部，我們的大部分公司成本都以瑞士法郎計。瑞士法郎兌美元也走軟。所以，如果你願意的話，公司的資金會少一點，而且會低一點。

If you take in constant currencies, it's probably hard for you to model on corporate costs, right? This year's quarter 2 costs were only $5 million lower than last year's quarter 2 cost. And of course, we do also work on corporate cost efficiencies. So I think that answers the corporate part.

如果您採用固定貨幣，您可能很難對公司成本進行建模，對吧？今年第二季度的成本僅比去年第二季度的成本低 500 萬美元。當然，我們也致力於提高企業成本效率。所以我認為這回答了公司部分。

In terms of the core cost on net financial results, we of course do have some income, right? We have some hedging gains, which is the other side of the currency impact. So that should also be a little bit lower. But of course, both of this is the corporate costs a part of our core operating income guidance in constant currencies. And then a bit of gains on the net financial results also versus prior year, but not so significant.

就淨財務業績的核心成本而言，我們當然有一些收入，對吧？我們有一些對沖收益，這是貨幣影響的另一面。所以這也應該低一點。但當然，這兩者都是我們以固定貨幣計算的核心營業收入指引的一部分。然後，與上一年相比，淨財務業績也有所增長，但並不那麼顯著。

Thanks, Harry. And then, Matthew, on the respiratory side of things, I think as you rightfully point out, we do have a business inhaled respiratory LABA/LAMA/ICS outside of the U.S., primarily in Europe and to some extent in emerging markets. And as well as we have the Xolair business outside [the United States] and severe asthma as well as a co-promote in the U.S. All those businesses remain intact. And of course, we will continue to drive them. We always do evaluate what is the right mix in the markets.

謝謝，哈利。然後，馬修，在呼吸方面，我認為正如你正確指出的那樣，我們在美國以外確實有一家吸入呼吸系統 LABA/LAMA/ICS 的企業，主要是在歐洲，在一定程度上在新興市場。除了我們在 [美國] 以外的 Xolair 業務和嚴重哮喘以及在美國的共同推廣外，所有這些業務都保持不變。當然，我們將繼續推動他們。我們總是評估市場中的正確組合。

And I think with our recent -- now with the transformation announcement, where we moved to a single Innovative Medicines unit in every country that we operate in, we are going through an exercise to ask what is the right portfolio -- not necessarily specific to respiratory. But what is the right portfolio of medicines for us to really focus our resources on? And where can we optimize or deprioritize so that we drive the most growth out of the business and really have the most impact that we can from the portfolio? So as we get to better clarity on those decisions and if anything changes, we'll of course let you know.

我認為，隨著我們最近——現在隨著轉型公告，我們在我們經營的每個國家轉移到一個創新藥物部門，我們正在通過一個練習來詢問什麼是正確的投資組合——不一定特定於呼吸系統。但是，我們真正將資源集中在哪些藥物組合上才是正確的呢？我們可以在哪些方面進行優化或取消優先級，以便我們從業務中獲得最大的增長，並真正從投資組合中產生最大的影響？因此，當我們更清楚地了解這些決定時，如果有任何變化，我們當然會通知您。

Vas, I don't know if my mic is on. I don't know whether a follow-up is appropriate. But could we see those spun out with Sandoz, given that they'd fit with that kind of long life cycle ex U.S. footprint that Sandoz has?

Vas，我不知道我的麥克風是否打開。不知道後續是否合適。但是，考慮到它們符合 Sandoz 在美國以外的那種長生命週期的足跡，我們能否看到那些與 Sandoz 分離的產品？

So I'm getting in trouble with all of my IR colleagues for taking your follow-on, Matthew, but I will answer it since we've known each other for so long. Right now, our intention is not to move any of our Innovative Medicines business with any consideration with Sandoz. We'll keep Sandoz as a pure-play small molecule generics and biosimilars business.

所以我和我所有的 IR 同事都因為你的後續行動而遇到了麻煩，馬修，但我會回答這個問題，因為我們已經認識了這麼久。目前，我們的意圖是不考慮與山德士一起移動我們的任何創新藥物業務。我們將把 Sandoz 保留為一家純粹的小分子仿製藥和生物仿製藥企業。

Sorry, Samir.

對不起，薩米爾。

Your next question comes from the line of Wimal Kapadia from Bernstein.

您的下一個問題來自 Bernstein 的 Wimal Kapadia。

So just firstly, with Kisqali, you previously suggested that adjuvant is a $6 billion opportunity. But I'm just curious how we should think about it. Because when you look at the epidemiology, it would suggest a much larger opportunity in intermediate patient pool. So I'm just curious, what assumptions you're making in terms of which -- actually receive the drug in this population? Because really, if you see a decent penetration, the market potential should be significantly larger.

所以首先，對於 Kisqali，您之前曾建議佐劑是一個 60 億美元的機會。但我只是好奇我們應該如何看待它。因為當您查看流行病學時，這表明在中間患者池中存在更大的機會。所以我很好奇，你在做出什麼樣的假設——實際上在這個人群中接受了藥物？因為真的，如果你看到一個不錯的滲透率，市場潛力應該會大得多。

And then just to be cheeky because we've done one round. Just on Sabatolimab. Given the delay in filing due to needing Phase III OS data and the high hopes that physicians seem to have for VENCLEXTA in MDS from the VERONA trial, I'm just curious how you're thinking about the potential for the product in MDS at this point. Does it now become somewhat of a lower priority? Or do you still believe that greater than $1 billion opportunity you discussed previously in MDS is still feasible?

然後只是為了厚臉皮，因為我們已經完成了一輪。就在 Sabatolimab 上。鑑於由於需要 III 期 OS 數據而導致提交延遲，以及醫生似乎對 VERONA 試驗中 MDS 中的 VENCLEXTA 寄予厚望，我只是好奇您如何看待該產品在 MDS 中的潛力觀點。它現在是否變得有些低優先級？還是您仍然相信您之前在 MDS 中討論的超過 10 億美元的機會仍然可行？

Yes. Thanks, Wimal. On Kisqali in the adjuvant setting, we do believe that with the possibility of adding intermediate risk on top of high risk, that is a significant expansion in the patient population, probably 3 to 4x what we see in the high-risk patient population.

是的。謝謝，維馬爾。在輔助設置中的 Kisqali 上，我們確實相信，在高風險之上增加中度風險的可能性，這是患者群體的顯著擴張，可能是我們在高風險患者群體中看到的 3 到 4 倍。

We previously guided to, I think, $6 billion based on what we saw in kind of consensus outlooks in various market projections. But I mean, I would agree that if we are successful in demonstrating a meaningful benefit across that entire intermediate risk range, there could be a larger opportunity for the medicine. And we're certainly doing that work now as we move towards the final readout of the study.

我認為，根據我們在各種市場預測中看到的共識前景，我們之前將其引導至 60 億美元。但我的意思是，我同意，如果我們成功地在整個中間風險範圍內證明了有意義的益處，那麼藥物可能會有更大的機會。我們現在肯定正在做這項工作，因為我們正朝著研究的最終讀數邁進。

So I agree. It is a significant opportunity and could be a fundamental inflection point for the company if Kisqali is successful, and most importantly, for all of those women with breast cancer who need better therapeutics so that their cancers don't recur. But I think it's a good push, and we'll try to come back with better numbers.

所以我同意。如果 Kisqali 成功，這對公司來說是一個重要的機會，並且可能是一個基本的轉折點，最重要的是，對於所有需要更好的治療方法以免癌症復發的乳腺癌女性來說。但我認為這是一個很好的推動，我們會嘗試以更好的數字回來。

On Sabatolimab, I think the data that we have suggests that we need to wait for the OS data in Phase III. The opportunity for this medicine is both across AML and MDS. We do note that there is a rapidly changing treatment landscape in MDS. Nonetheless, we think that, if the medicine has a unique mechanism of action with targeting TIM-3 and could be used in combination with other agents, and if the safety profile would reasonably hold up, we do think it has that $1 billion potential in each of the indications.

關於 Sabatolimab，我認為我們擁有的數據表明我們需要等待第三階段的操作系統數據。這種藥物的機會在於 AML 和 MDS。我們確實注意到，MDS 的治療環境正在迅速變化。儘管如此，我們認為，如果該藥物具有針對 TIM-3 的獨特作用機制並且可以與其他藥物聯合使用，並且如果安全性能夠合理維持，我們確實認為它具有 10 億美元的潛力每個適應症。

But I wouldn't know. We need to wait for now for the full Phase III studies. And it wouldn't be prudent to put too much more on to it until we see that data readout.

但我不會知道。我們現在需要等待完整的 III 期研究。在我們看到數據讀數之前，在上面放太多東西是不明智的。

Next question, operator. And we'll try to do as many as we can in the last 5 minutes.

下一個問題，接線員。我們會在最後 5 分鐘內盡可能多地做。

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 Richard Parkes。

It's a follow-up on Leqvio in the U.S. Feedback we've received recently from U.S. physicians is that they're still seeing difficulties accessing injection centers and that reimbursement is still challenging. So I just wondered whether that's just an issue of experience and lack of infrastructure or whether there are the barriers that payers are putting into place in order to manage utilization, such as requirements for specific injection centers or anything you haven't expected.

這是對美國 Leqvio 的後續行動。我們最近從美國醫生那裡收到的反饋是，他們仍然看到進入註射中心有困難，而且報銷仍然具有挑戰性。所以我只是想知道這是否只是經驗和缺乏基礎設施的問題，或者是否存在付款人為了管理利用率而設置的障礙，例如對特定注射中心的要求或任何你沒有預料到的東西。

And then can I just ask a clarification? Because I think I heard you say that the final NATALEE readout was the end of next year, but I might have missed that. So if I could just clarify that time line.

然後我可以問一個澄清嗎？因為我想我聽到你說最終的 NATALEE 讀數是明年年底，但我可能錯過了。所以，如果我能澄清一下時間線。

Yes, absolutely. So first on NATALEE, it would be in the second half of next year, which I think is what we guided to previously. Not end. I didn't mean to give a new time line. Time line is exactly as we've said previously, so no change in time line.

是的，一點沒錯。所以首先在 NATALEE，它會在明年下半年，我認為這是我們之前指導的。沒有結束。我並不是要給出一個新的時間線。時間線和我們之前說的完全一樣，所以時間線沒有變化。

On Leqvio. I think there is an element of experience and also understanding the Part D and the payer dynamic. There is 30% to 40% of patients who are in Medicare Part D fee-for-service that don't have any relevant blocks and can access the medicines. There is a set of patients where there is a prior authorization, and then there's a set of patients that do have a step edit.

在 Leqvio 上。我認為有一個經驗元素，也了解 D 部分和付款人動態。在 Medicare D 部分按服務收費的患者中，有 30% 到 40% 沒有任何相關限制並且可以獲得藥物。有一組患者有事先授權，然後有一組患者確實有一個步驟編輯。

And I think physicians are just getting experience seeing how different patients actually have to move through the system. I think as they get smarter about that and understand those dynamics, as offices get better and as we get better at supporting offices, we should be able to overcome those. And as I noted, we have a very high percentage of patients covered now to the full Leqvio label.

而且我認為醫生剛剛獲得經驗，了解不同的患者實際上必須如何通過該系統。我認為，隨著他們對此變得更聰明並了解這些動態，隨著辦公室變得更好以及我們在支持辦公室方面變得更好，我們應該能夠克服這些問題。正如我所指出的，我們現在有非常高比例的患者獲得了完整的 Leqvio 標籤。

To my knowledge, there's no restrictions on which alternative injection centers or other administration centers that can be used that would really be impacting that perception. I think it's just, if you happen to put a certain -- a patient on certain insurance as the first patient through the system, you do have to work through the reimbursement hurdles and get that all set up in the office. Normal things for a U.S. health care launch in cardiovascular. Things that we're well adept at managing, having successfully launched Entresto. And things we're working very hard to resolve as quickly as possible.

據我所知，對於可以使用哪些替代注射中心或其他管理中心沒有任何限制，這會真正影響這種看法。我認為這只是，如果您碰巧將某個特定的患者作為第一個通過該系統的患者投保，您確實必須克服報銷障礙並在辦公室進行所有設置。美國在心血管領域推出的醫療保健服務很正常。我們非常擅長管理的事情，成功推出了 Entresto。我們正在努力盡快解決問題。

Your next question comes from the line of Richard Vosser from JPMorgan.

您的下一個問題來自摩根大通的 Richard Vosser。

Just one on the LOEs that we should expect in '23. I think Promacta is slated, but there are some formulation and use patents that might actually push that out.

只有一個關於我們應該在 23 年期待的 LOE。我認為 Promacta 是計劃中的，但有一些配方和使用專利實際上可能會推出。

And maybe similarly, just anything else like Lucentis that we should be thinking about?

也許類似地，像 Lucentis 這樣我們應該考慮的其他東西？

Yes. Thanks, Richard. Yes, on Promacta, we're continuing to work to really support all -- the full range of patents we have on the medicine. And I think in appropriate time, if we're successful, we'll provide an update on Promacta. But it's something we're very focused on.

是的。謝謝，理查德。是的，在 Promacta 上，我們將繼續努力真正支持所有人——我們在藥物方面擁有的全部專利。我認為在適當的時候，如果我們成功了，我們將提供關於 Promacta 的更新。但這是我們非常關注的事情。

And then on Lucentis, we do expect the biosimilar -- a few biosimilar entries in Europe. I think it's important to note that, with the broad scale availability of Avastin for now many, many years, that we believe the biosimilars market has in effect already happened in Europe. So we would expect a moderate decline on the launch of the biosimilars, but maybe not what you would see with other biologics when biosimilar entry occurs. So that's how we're forecasting Lucentis now for the coming years.

然後在 Lucentis 上，我們確實期待生物仿製藥——歐洲的一些生物仿製藥。我認為重要的是要注意，隨著阿瓦斯汀的廣泛供應，我們相信生物仿製藥市場實際上已經在歐洲發生。因此，我們預計生物仿製藥的推出會適度下降，但可能不是您在生物仿製藥進入時看到的其他生物製劑。這就是我們現在對未來幾年 Lucentis 的預測方式。

And one last question, operator?

最後一個問題，接線員？

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

您的最後一個問題來自美國銀行的 Graham Parry。

So just one on Gilenya. So obviously, you've had the overturning the decision from the appeal court, and you said you're going to petition. So just help us understand time frame for the petition. Does that prevent a launch happening in the intervening time frame? So your level of confidence that we won't see a launch this year? Or is the guidance just a guidance assumption, but that could change depending on what happens with the court?

所以只有一個關於Gilenya的。所以很明顯，你已經推翻了上訴法院的決定，你說你要請願。因此，請幫助我們了解請願書的時間範圍。這是否會阻止在中間時間範圍內發生髮射？所以你對我們今年不會看到發射的信心程度？還是指導只是一個指導假設，但這可能會根據法院發生的情況而改變？

And then just one last one. Kisqali growth was just well above prescription growth, although, obviously, we are seeing resurgence there. Is that reflective of real volume growth? Or could it be just a sort of prescription retail versus other channels that we're seeing, and actually, the reported growth is much more in line with the real volume growth?

然後只是最後一個。 Kisqali 的增長遠高於處方增長，儘管顯然我們看到了那裡的複蘇。這是否反映了實際的銷量增長？或者它可能只是一種處方零售而不是我們看到的其他渠道，實際上，報告的增長更符合實際銷量增長？

Yes. On Gilenya, right now, no generics can enter the market. We are petitioning the court. And we would expect to get a response from the court in the coming months. If granted, then it would be another set of months before the hearing. And then the hearing will take another set of months. As a reminder, we guided to generics entering in 2024. So really, what we look at here is, between now and that time line, when exactly the entry might happen.

是的。在 Gilenya，目前沒有仿製藥可以進入市場。我們正在向法院請願。我們希望在未來幾個月內得到法院的回應。如果獲得批准，那麼聽證會前將再過幾個月。然後聽證會將需要另外幾個月的時間。提醒一下，我們指導仿製藥在 2024 年進入。所以說真的，我們在這裡看到的是，從現在到那個時間線，什麼時候可能會發生進入。

So we'll know more, I think, as the court gives us feedback once we -- we have yet to be -- we are in the process of submitting the petition. The petition would then need to be reviewed. We either be rejected at that point or the petition would be granted and then we would then move forward from there. So that's kind of the scenarios right now on Gilenya. But to remind again, the [long] update was anyway in '24. So from a midterm growth standpoint, this is not having a significant bearing.

所以我們會知道更多，我認為，一旦我們——我們還沒有——我們正在提交請願書，法院就會給我們反饋。然後需要審查該請願書。我們要么在那時被拒絕，要么申請將被批准，然後我們將從那裡繼續前進。所以這就是Gilenya現在的情景。但再次提醒一下，[long] 更新無論如何都是在 24 年。因此，從中期增長的角度來看，這並沒有重大影響。

Also in Europe, where we were granted the patent by the European patent office, we expect that patent to be issued later this year, and we'll continue to defend Gilenya across Europe. So a lot of things, puts and takes, I think, on Gilenya at the moment.

同樣在歐洲，我們獲得了歐洲專利局授予的專利，我們預計該專利將在今年晚些時候發布，我們將繼續在整個歐洲捍衛 Gilenya。所以很多事情，我認為，目前在吉倫亞身上。

And I think on your question on Kisqali, I don't know the answer, so we'll just have to follow-up with you. But we'll get back to you on that to make sure you're clear on the volume/price dynamics. But I would say that what we see in our numbers is a strong growth in underlying demand for Kisqali that we'd like to sustain.

我想關於你關於 Kisqali 的問題，我不知道答案，所以我們只需要跟進你。但我們會就此與您聯繫，以確保您清楚了解數量/價格動態。但我想說的是，我們從數據中看到的是我們希望維持的對 Kisqali 潛在需求的強勁增長。

So thanks, everyone, for joining the call. Apologies we didn't get to every single question. But I really appreciate everyone taking the time, and we'll look forward to catching up soon. Bye-bye.

非常感謝大家加入電話會議。抱歉，我們沒有回答每一個問題。但我真的很感謝大家抽出時間，我們期待很快趕上。再見。

Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.

謝謝你。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。