Novartis AG (NVS) 2026 Q2 法說會逐字稿

Good afternoon, and welcome to the Novartis Q2 2026 results release conference cll and live webcast. (Operator Instructions)

下午好，歡迎參加諾華（Novartis）2026 年第二季（Q2）業績發布電話會議與線上直播。（接線員指示）

A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. With that, I would like to hand over to Mr. Nigel Trotman, Head Business Planning and Analysis and Digital Finance. Please go ahead, sir.

本次電話會議（含問答環節）的錄音，將於會議結束後不久在我們的網站上提供。接下來，我想把時間交給商業規劃與分析暨數位財務負責人 Nigel Trotman 先生。先生，請開始。

Thank you, Sharon. Good morning and good afternoon, and welcome, everyone, to our Q2 2026 conference call. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K that respectively were filed with and furnished to the US. Securities and Exchange Commission.

謝謝你，Sharon。各位早安、午安，歡迎大家參加我們 2026 年第二季電話會議。今天所呈現的資訊包含前瞻性陳述，涉及已知與未知的風險、不確定性及其他因素。這些因素可能導致實際結果與此等陳述所明示或暗示的任何未來結果、表現或成就存在重大差異。關於其中部分因素的說明，請參閱公司 Form 20-F，以及最近一期以 Form 6-K 向美國提交與提供的季度業績資料。美國證券交易委員會（Securities and Exchange Commission）。

Before we get started, and as a reminder, please kindly limit yourselves to one question at a time, and we'll cycle through the queue as needed. And with that, I'll hand over to Vas.

在開始之前，也提醒各位，請每次僅提一個問題，我們將視需要依序輪流回答隊列中的提問。接下來，我把時間交給 Vas。

Thank you, Nigel, and thanks, everyone, for joining today's conference call. Moving to slide 4. As you saw in the results we released earlier today, Novartis delivered strong performance across our priority brands and launches, while advancing the pipeline, allowing us to return to growth in the second quarter. The business grew 1% in constant currencies in USD, and we had flat core operating income at $5.9 billion. Mukul will go through the numbers in more detail later on in the call, but we're reaffirming our full year guidance for 2026.

謝謝你，Nigel，也感謝各位參加今天的電話會議。請看投影片第 4 頁。如同各位稍早看到我們今天發布的業績，諾華在重點品牌與新上市產品上展現強勁表現，同時推進研發管線，使我們在第二季重回成長軌道。以美元計、按固定匯率（constant currencies）計算，業務成長 1%，核心營業利益持平於 59 億美元。Mukul 稍後會在會議中更詳細說明數字，但我們重申 2026 年全年財測指引。

We also had some important pipeline highlights, which I'll talk about more during the course of the conference call, including updated Kisqali OS data, the Del-brax, biomarker data in FSHD as well as some other regulatory milestones we were able to deliver over the course of the quarter.

我們在研發管線方面也有一些重要亮點，我會在本次電話會議過程中進一步說明，包括更新的 Kisqali 總存活期（OS）數據、Del-brax、FSHD 的生物標記（biomarker）數據，以及本季我們達成的其他一些法規里程碑。

Now moving to slide 5. Our growth drivers continued a strong trajectory in quarter two. They were up 26% in constant currencies. Some of the highlights include strong performance from Kisqali, Kesimpta, Scemblix, solid performance from Pluvicto and strong performance as well from Leqvio. So all taken together, these growth drivers are performing strongly. We believe that gives us momentum going into the second quarter -- second half of the year as we now move beyond the (inaudible) patent and set us up well to deliver on our midterm growth guidance.

接著看投影片第 5 頁。我們的成長動能產品在第二季持續維持強勁走勢。按固定匯率計算成長 26%。亮點包括 Kisqali、Kesimpta、Scemblix 的強勁表現，Pluvicto 的穩健表現，以及 Leqvio 同樣強勁的表現。綜合而言，這些成長動能產品表現非常強勁。我們相信，這讓我們在進入下半年時具備動能——隨著我們如今走出（聽不清）專利影響，也為達成中期成長指引奠定良好基礎。

Now moving to slide 6. Kisqali was up 43% in constant currencies on the quarter. We outpaced the CDK4/6 market. We had strong performance in the US and outside the US.

接著看投影片第 6 頁。Kisqali 本季按固定匯率計算成長 43%。我們的成長速度超越 CDK4/6 市場。我們在美國及美國以外市場皆有強勁表現。

In the US, we were up 39%, reaching over $1 billion in sales for the first time. We continued our metastatic express cancer leadership, with an increasing share in first line. And we also sustained our early breast cancer NBRx leadership with 58% of new patients now from our exclusive N0 and N1 nodal population. We also continue to grow our total prescriber base, up 16%, and we see future growth continuing to be driven by these exclusive Kisqali early breast cancer segment.

在美國，我們成長 39%，銷售額首次突破 10 億美元。我們持續維持轉移性乳癌領導地位，且在一線治療的市占率持續提升。同時，我們也維持早期乳癌（eBC）的 NBRx 領先地位，目前 58% 的新病患來自我們獨有的 N0 與 N1 淋巴結族群。我們也持續擴大整體開立處方醫師基礎，成長 16%；我們看到未來成長仍將由這些 Kisqali 獨有的早期乳癌細分市場所驅動。

Outside of the US, we were up 49% with continued metastatic leadership. Our growth was accelerating in our eBC launches. We're now approved in 76 countries and reimbursed in 42. And as you can see in the chart, in case study in Germany, we reached 79% eBC NBRx share. We're having similar performance in other key markets. Overall, we're pleased with the trajectory for Kisqali and remain confident in our $10 billion sales goal.

在美國以外市場，我們成長 49%，並持續保持轉移性領導地位。我們在早期乳癌（eBC）上市推進中的成長正在加速。目前我們已在 76 個國家獲准，並在 42 個國家取得給付。如圖所示，以德國的案例來看，我們在 eBC 的 NBRx 市占率達到 79%。我們在其他關鍵市場也看到類似表現。整體而言，我們對 Kisqali 的發展軌跡感到滿意，並仍對 100 億美元銷售目標充滿信心。

Now moving to slide 7. We're announcing today also updated 6-year follow-up data demonstrating that Kisqali showed clinically meaningful OS in that broadest at-risk eBC population. That data will be presented at an upcoming congress. This is the 6th-year prespecified landmark data for iDFS as well as for OS. The iDFS benefit continues over time and continues to strengthen the case for use in the broadest at-risk eBC population.

接著看投影片第 7 頁。我們今天也宣布更新的 6 年追蹤數據，顯示 Kisqali 在最廣泛、具風險的早期乳癌（eBC）族群中展現具臨床意義的總存活期（OS）效益。該數據將於即將舉行的醫學會議上發表。這是針對無侵襲性疾病存活（iDFS）以及 OS 的第 6 年預先指定（prespecified）里程碑數據。iDFS 的效益隨時間持續，並進一步強化其在最廣泛、具風險的 eBC 族群中使用的理由。

Safety remained consistent with known profile of Kisqali. We believe this data underscores the value of dual emission with Kisqali and endocrine therapies across all subgroups. So we'll look forward to providing the full details of this data, as I mentioned, in our upcoming medical congress.

安全性與 Kisqali 已知的特性一致。我們認為，這些數據凸顯 Kisqali 與內分泌治療在所有亞組中的雙重作用價值。因此，如我所提，我們期待在即將到來的醫學會議上提供這些數據的完整細節。

Then moving to slide 8. Kesimpta had another strong quarter, up 32%, continuing to increase its share across our key markets. In the US, we were up 32% in quarter two, increasing our TRx share in both B cell and MS markets. Importantly, we're going our NBRx share ahead of our competitors in the first line and first switch segments, which are our targets segments for this medicine.

接著看投影片第 8 頁。Kesimpta 再度交出強勁的一季，成長 32%，並持續在我們的主要市場提升市占率。在美國，第二季成長 32%，在 B 細胞與多發性硬化症（MS）市場的 TRx 市占率皆提升。重要的是，我們在一線與首次換藥（first switch）族群的 NBRx 市占率領先競品，這些正是本藥物的目標族群。

Outside of the US, also very good performance. We're seeing strong growth in Europe as well as sustain NBRx growth in our top international markets. We see a continued opportunity in these international markets, given that 2/3 of patients remain treated with older therapies, not on B cell therapies. This is a clear opportunity for expansion over time.

在美國以外市場同樣表現非常好。我們看到歐洲強勁成長，並在主要國際市場維持 NBRx 成長。我們認為這些國際市場仍有持續機會，因為仍有 2/3 的病患使用較舊療法，尚未使用 B 細胞療法。這是隨時間推進可明確擴張的機會。

We also continue to progress our next-generation evidence and continued life cycle management for Kesimpta. Our ongoing Phase III with a once every 2-month dose Kesimpta per maintenance dosing is on track for a 2027 readout.

我們也持續推進 Kesimpta 的次世代證據建立與生命週期管理。我們正在進行的第三期試驗，評估每 2 個月一次給藥的 Kesimpta 維持治療方案，進度如期，預計於 2027 年讀出結果。

So moving to slide 9. Pluvicto grew 43%, and this is driven primarily by our PSMA population in the pre-taxane in mCRPC. We also see now acceleration outside of the US In the US, our pre-taxane is now driving over 70% of new patients. We continue to focus on use after the first ARPi. This is our largest segment. And we believe we now will have the opportunity to drive further growth given that the NCCN guidelines have been updated to remove routine use of a second ARPi in this setting.

接著看投影片第 9 頁。Pluvicto 成長 43%，主要由 mCRPC 中 pre-taxane 的 PSMA 族群所驅動。我們也看到美國以外市場正在加速；在美國，pre-taxane 目前已帶動超過 70% 的新病患。我們持續聚焦於第一個 ARPi 之後的使用。這是我們最大的細分市場。我們相信，隨著 NCCN 指引已更新、在此情境下移除常規使用第二個 ARPi 的建議，我們將有機會推動進一步成長。

We continue to expand our sites, over 880 sites now providing Pluvicto. And a lot of our focus now is getting additional depth in those sites, especially as we prepare now for the mHSPC launch.

我們持續擴增治療據點，目前已有超過 880 個據點提供 Pluvicto。我們目前的重點之一，是在這些據點中提升更深度的滲透，特別是在我們為 mHSPC 上市做準備之際。

Outside of the US, strong growth, 83% growth in new patients, with accelerating adoption in Europe and launch momentum in Japan and China. The number of sites now that are providing RLT outside of the US to over 650. This sets us up well as well for our future RLT pipeline, where we're excited to continue to progress beyond Pluvicto, Lutathera, hopefully in additional cancer types in the coming years.

在美國以外地區，新病患成長強勁，新病患數成長83%，歐洲採用加速，且在日本與中國的上市動能良好。目前在美國以外提供RLT的據點數已超過650個。這也讓我們能更好地布局未來的RLT產品線；我們很期待在Pluvicto、Lutathera之外，於未來幾年在更多癌症類型上持續推進。

The next wave of growth for Pluvicto will be the approval -- expected approval in quarter three in mHSPC. This will increase the eligible patient pool by 75%, give us a strong foundation for further growth. 2/3 of the patients in the PSMA addition population are with healthcare providers that currently use Pluvicto today. So we think we have -- or with established referral patterns, so we think we have a strong base for rapid adoption.

Pluvicto的下一波成長將來自於在mHSPC的核准——預期於第三季獲得核准。這將使符合資格的病患池增加75%，為進一步成長奠定堅實基礎。PSMA新增適應症族群中有2/3的病患，其醫療照護提供者目前就已在使用Pluvicto。因此我們認為我們已具備——或說已有既定的轉介模式——所以我們認為我們有很強的基礎可快速被採用。

And then we continue to progress the pipeline. We presented posting results for our actinium PSMA in mCRPC. This medicine is now being studied in the post-Pluvicto setting, in the post-chemo setting and then as well in the first-line mCRPC setting in combination with ARPi. So an opportunity here to life cycle manage Pluvicto for the longer term.

接著我們持續推進產品線。我們公布了在mCRPC中使用錒-PSMA的結果。此藥物目前正在Pluvicto治療後、化療後，以及作為第一線mCRPC並與ARPi合併治療的情境中進行研究。因此，這裡提供了一個機會，讓我們能以更長期的角度對Pluvicto進行生命週期管理。

So moving to slide 10. Leqvio had a strong quarter, growing 59%, driven by strong demand we saw across the globe. In the US, we were up 55% in quarter two. We outpaced the advanced lipid-lowering market. This was driven by monthly TRx growth of 49%, demonstrating Leqvio, the differentiated profile, strong persistency. The demand is being driven with increasing depth in the prior health systems that we're targeting.

接著看第10張投影片。Leqvio本季表現強勁，成長59%，主要由我們在全球看到的強勁需求所帶動。在美國，第二季成長55%。我們的表現超越了進階降脂市場。這主要由每月TRx成長49%所驅動，展現Leqvio差異化的產品特性與強勁的持續用藥率。需求的成長來自於我們鎖定的既有醫療體系中，滲透深度持續增加。

The most important segment for us remains the Medicare Part B segment, where we see 23.3% share, that's up 3.6% year-to-date. And we see an opportunity for continued advantage. I think even with orals launching, our opportunity remains for driving strong growth in the segment that wants infrequently administered physician-administered medicines for light lipid lowering in the United States, and we see us as attractive and growing segment that supports our peak sales potential in the US and beyond.

對我們而言最重要的區隔仍是Medicare Part B區隔，我們在此看到23.3%的市占率，年初至今上升3.6個百分點。我們也看到持續擴大優勢的機會。我認為即使口服藥物上市，我們在美國仍有機會在偏好低頻給藥、由醫師施打的降脂藥物之區隔中推動強勁成長；我們認為這是一個具吸引力且正在成長的區隔，可支撐我們在美國及其他地區的峰值銷售潛力。

Outside of the US, NRDL inclusion is a lock in significant demand. You saw that in quarter one. It continues in quarter two. Our market share has doubled now versus the NRDL -- we currently -- we were previously seen. We also see sustained growth in Europe and Japan. So overall, pleased with our performance.

在美國以外地區，納入NRDL帶來顯著需求的確立。你們在第一季已看到。第二季仍在延續。我們的市占率相較於納入NRDL之前已翻倍——目前——相較於我們先前的表現。我們也看到歐洲與日本的持續成長。整體而言，我們對表現感到滿意。

We keep generating additional data Leqvio, 3 world studies demonstrated that inclisiran Leqvio improves adherence and persistence compared to other advanced lipid lowering therapy. And then we also have the V-CHALLENGE head-to-head study of inclisiran versus bempedoic acid, which we will present in ESC. And lastly, we're on track as well for our 2 outcome studies to read out in 2027 for Leqvio.

我們持續產出Leqvio的更多數據；三項真實世界研究顯示，inclisiran（Leqvio）相較於其他進階降脂治療，可提升用藥依從性與持續性。此外，我們也有V-CHALLENGE頭對頭研究，比較inclisiran與bempedoic acid，我們將在ESC上發表。最後，我們也按計畫推進Leqvio的兩項結局研究，預計於2027年讀出結果。

Moving to slide 11. Scemblix had a very strong quarter, 89% constant currency growth driven by both US and ex-U.S. performance. In the US, we had 93% growth in the quarter. This is driven by sustained leadership across all lines. But importantly, we now expect to reach a first-line NBRx leadership share in the second half of the year. You can see steady improvements in that NBRx share -- first-line NBRx share.

接著看第11張投影片。Scemblix本季表現非常強勁，按固定匯率計成長89%，由美國與美國以外市場的表現共同帶動。在美國，本季成長93%。這主要由各治療線的持續領先地位所驅動。更重要的是，我們現在預期在今年下半年可在第一線NBRx市占率上達到領先。你們可以看到該NBRx市占率——第一線NBRx市占率——穩步改善。

Outside of the US, we're primarily still driven by the third line and beyond performance, with 75% NBRx share across our key markets. But importantly, for future growth, we're seeing early line adoption now starting to pick up. We are now approved in 65 countries outside of the US.

在美國以外地區，我們目前仍主要由第三線及以上的表現所帶動，在我們的主要市場中NBRx市占率達75%。但更重要的是，為了未來成長，我們看到早期治療線的採用現在開始加速。我們目前已在美國以外的65個國家獲得核准。

In Japan, we've already reached first-line NBRx leadership, as you can see in the lower chart. In Germany, our early NBRx first-line share is already up to 15%. So we're very excited for the trajectory of Scemblix and to continue to be a growth driver long into the future.

在日本，如下方圖表所示，我們已在第一線NBRx達到領先。在德國，我們的第一線早期NBRx市占率已提升至15%。因此我們對Scemblix的發展軌跡感到非常振奮，並期待其在未來很長一段時間持續成為成長動能。

Now with Cosentyx, we had a solid quarter, 10% constant currency growth, in part driven by some one-timers with still strong underlying growth. When you look at in the US, we were up 16%. You can see that in HS, we are steady in our NBRx share, in the high 40s, and we expect that to continue. We see steady demand growth in HS and IV. Underlying growth in the US is around mid-single digits, as we've guided to in the past.

至於Cosentyx，本季表現穩健，按固定匯率計成長10%，部分受一些一次性因素帶動，但基本面成長仍然強勁。在美國，我們成長16%。你們可以看到在HS領域，我們的NBRx市占率維持穩定，約在40%後段，我們預期將持續如此。我們看到HS與IV的需求穩步成長。美國的基本面成長約為中個位數百分比，與我們過去的指引一致。

And outside of the US, continued solid growth in Europe. We do see additional challenges in China with more competition, but we're able to manage that to maintain the overall global performance of the brand.

而在美國以外地區，歐洲持續穩健成長。我們確實在中國因競爭加劇而面臨更多挑戰，但我們能加以管理，以維持該品牌整體的全球表現。

And then we're excited by the Phase III REPLENISH-PMR, (inaudible), which we recently published and presented at EULAR. It showed very strong data with sustained remission at 52 weeks. That was twice as high in patients treated with Cosentyx versus placebo. So we're anticipating FDA approval for that indication in the second half and remain on track for the $8 billion peak sales guidance that we've previously provided.

此外，我們也對第三期REPLENISH-PMR（聽不清）感到振奮；我們近期已發表並在EULAR上報告。結果顯示數據非常強勁，在52週時仍可維持緩解。接受Cosentyx治療的病患，其緩解率是安慰劑的兩倍。因此我們預期該適應症將於下半年獲得FDA核准，並仍維持先前提供的80億美元峰值銷售指引進度。

Now moving to slide 13. Rhapsido continues its strong launch trajectory with Phase III CIndU data now available to support our broader potential in urticaria. First, targeting -- starting with the CSU launch, we see continued solid US uptake, over 4,000 prescribers, over 10,000 patients treated, 60% of those patients are treated in the first-line setting. We see steady expansion in our patient access.

接著看第13張投影片。Rhapsido持續展現強勁的上市軌跡，目前已有第三期CIndU數據可用，以支持我們在蕁麻疹領域更廣泛的潛力。首先，從CSU上市切入，我們看到美國持續穩健的採用：超過4,000位開立處方醫師、超過10,000名病患接受治療，其中60%的病患在第一線治療情境中使用。我們看到病患可近性持續擴大。

We have 2 of the 3 major PBMs now covering remibrutinib, Rhapsido with (inaudible). And in second half, we expect steady expansion in that access with an effective bridge and sample program in place. We don't expect an inflection per se. We think this will be steady expansion. We want to ensure that we're disciplined in how we approach getting reimbursement the multiple indications we hope to secure for remibrutinib over time.

目前三大PBM中已有兩家開始給付remibrutinib（Rhapsido），並搭配（聽不清）。在下半年，我們預期在有效的銜接用藥與試用樣品計畫到位下，可近性將持續擴大。我們不預期會出現所謂的明顯拐點。我們認為這將是穩步擴張。我們希望確保在爭取remibrutinib未來可望取得的多項適應症之給付時，採取審慎且有紀律的做法。

Outside of the US, we see good traction in China, launches and are going across Europe and the Middle East. And we'll see further expansion in the second half post the EMEA, Japan and Swiss approvals.

在美國以外地區，我們在中國看到良好進展，並且在歐洲與中東各地持續推進上市。在獲得EMEA、日本與瑞士核准後，下半年將進一步擴張。

Now importantly, in chronic inducible urticaria, we presented our REMIND data supporting remibrutinib has the potential as the first targeted therapy for chronic inducible urticaria. We had early and broad efficacy with onset as early as we do in the 2 additional largest subtypes, consistent 12-week responses versus placebo. So we're on track for the FDA approval in SD, which is the most common CIndU subtype, 2/3 of CIndU patients. And then we'll have global funds across all 3 subtypes later this year.

現在重要的是，在慢性誘發性蕁麻疹方面，我們提出了 REMIND 數據，支持 remibrutinib 有潛力成為慢性誘發性蕁麻疹的首個標靶治療。我們觀察到早期且廣泛的療效，起效時間最早可如同另外兩個最大亞型一樣迅速，且在 12 週時相較安慰劑呈現一致的反應。因此，我們正按計畫推進在 SD（最常見的 CIndU 亞型，約占 CIndU 病患的 2/3）取得 FDA 核准。接著，我們將在今年稍晚於全球範圍內涵蓋全部 3 個亞型。

Just as a reminder, we expect -- we estimate in the US, there's about 100,000 CIndU patients that are uncontrolled with antihistamines with no other treatment options. So this is a significant expansion in the population that can be helped by Rhapsido.

提醒一下，我們預期——我們估計在美國約有 100,000 名 CIndU 病患使用抗組織胺仍無法控制，且沒有其他治療選項。因此，這將顯著擴大可由 Rhapsido 受益的人群。

Now turning to slide 14. We also presented some updated data on Ianalumab, showing the favorable ESSDAI benefit of the medicine and longer-term follow-up, and we remain on track for a US launch in Sjögren’s disease in the second half. So you can see on the left-hand side of this chart, in our pooled NEPTUNUS data, you can see the consistent benefits in ESSDAI, a statistically significant versus the placebo arm across both studies when both demonstrating the benefits we seek with the medicine.

接著看第 14 張投影片。我們也公布了 Ianalumab 的一些更新數據，顯示該藥物在 ESSDAI 上具有有利的獲益以及更長期的追蹤結果；我們仍按計畫在下半年於美國推出用於乾燥症（Sjögren’s disease）。如圖表左側所示，在我們彙總的 NEPTUNUS 數據中，可看到 ESSDAI 的一致性獲益；在兩項研究中相較安慰劑組皆達到統計上顯著，並且兩項研究都展現了我們希望該藥物帶來的效益。

And then as well, we presented 108-week long-term extension data, which showed that we can maintain the benefits of Ianalumab over time. And then also was supported by clinically meaningful improvements for the placebo crossover group when crossing over on to the active arm. Also throughout all of these long-term follow-ups, we see a favorable safety profile, no increase in adverse events. So this supports Ianalumab's multi-blockbuster potential. We're on track for the ITP first-line readout in the second half of 2026. The SLE and (inaudible) nephritis Phase III readouts in 2027 and the systemic sclerosis Phase II readout as well in 2027.

此外，我們也公布了 108 週的長期延伸試驗數據，顯示 Ianalumab 的獲益可隨時間維持。同時，安慰劑交叉至有效治療組的受試者在交叉後也出現具臨床意義的改善，進一步支持上述結果。在所有這些長期追蹤中，我們看到良好的安全性概況，不良事件並未增加。因此，這支持 Ianalumab 具備多重「超級暢銷藥」潛力。我們仍按計畫於 2026 年下半年取得 ITP 一線治療的讀出結果。SLE 與（聽不清）腎炎的第三期讀出預計在 2027 年，系統性硬化症的第二期讀出也同樣在 2027 年。

So turning to slide 15. I wanted to provide an update on 2 of the acquired programs (inaudible). First with Del-zota. We achieved our first FDA submission for the therapeutic use of an antibody also conjugate that FDA submission is for accelerated approval in the DMD44, using dystrophin as a surrogate biomarker. We previously received FDA breakthrough therapy designation for this.

接著看第 15 張投影片。我想就兩個併購取得的專案提供最新進展（聽不清）。首先是 Del-zota。我們已完成首個 FDA 申請，針對一項抗體（亦為）偶聯物的治療用途；該申請為 DMD44 的加速核准，使用肌營養不良蛋白（dystrophin）作為替代生物標記。我們先前已獲得 FDA 突破性療法認定。

The submission package is based on the outstanding data that we had in the EXPLORER44 study as well as long-term follow-up. And we expect the first launch here in the first half of 2027 with the ongoing Phase III studies ongoing. We have multiple follow-on programs now targeting additional exons that we'll be bringing forward as well. So we're quite excited to leverage this technology to take on DMD across multiple subtypes.

本次申請資料包是基於我們在 EXPLORER44 研究中取得的卓越數據以及長期追蹤結果。我們預期將於 2027 年上半年首次上市，同時第三期研究仍在進行中。目前我們也有多個後續專案，鎖定其他外顯子，並將一併推進。因此，我們非常期待運用這項技術，在多個亞型上挑戰 DMD。

And then with respect to the Del-brax data, we read out in the quarter as well that the Phase I/II study at the target dose that we are taking into Phase III studies met its primary and key secondary biomarker endpoints. So as a reminder, this is a study that looked at KHDC1L, (inaudible) in the plasma. KHDC1L is a protein that the downstream and believe to be regulated, the (inaudible) being the gene that's impacted in FSHD. And so having these plasma biomarkers indicates that we have strong target engagement and muscle damage reduction as indicated by the statistically significant, creating reductions that we saw.

至於 Del-brax 的數據，我們也在本季讀出：在我們將帶入第三期研究的目標劑量下，第一/二期研究達成其主要與關鍵次要生物標記終點。提醒一下，該研究檢測了血漿中的 KHDC1L（聽不清）。KHDC1L 是一種蛋白質，我們認為其下游受到調控；而（聽不清）是 FSHD 中受影響的基因。因此，這些血漿生物標記顯示我們具有強勁的靶點結合（target engagement），並且如我們所見到的具統計顯著的（聽不清）下降所示，肌肉損傷有所減少。

Our base case remains a submission in 2028. But based on the data that we've seen in the biomarkers and ongoing work we're currently conducting to strong -- hopefully correlate biomarkers to [DUCs 4] as well as clinical improvements in these patients, we plan to engage FDA and other regulatory authorities in the coming months. And then we'll ultimately provide an update if those regulatory authorities support our ability to file this medicine based on this data.

我們的基本情境仍是於 2028 年提交申請。但基於我們在生物標記上看到的數據，以及目前正在進行的工作——希望能將生物標記與 [DUCs 4] 以及這些病患的臨床改善建立更強的相關性——我們計畫在未來幾個月與 FDA 及其他監管機關進行溝通。之後，若監管機關支持我們可基於這些數據提交該藥物申請，我們將提供最新進展。

Now moving to slide 16. So we're on track for a busy second half. We already had 4 readouts in the first half. In the second half, we expect with pelacarsen, remibrutinib and del-desiran readouts in the coming months and then before the end of the year, readouts for Ianalumab, Rhapsido and HS as well as additional readouts for Phase II programs, QCZ484 as well as VHB937 in ALS. So exciting, I think, second half coming up, solid first half out of the year and looking forward to continued progress in the months ahead.

接著看第 16 張投影片。我們正按計畫迎來忙碌的下半年。上半年我們已經有 4 項讀出。下半年，我們預期在未來幾個月將有 pelacarsen、remibrutinib 與 del-desiran 的讀出；並在年底前取得 Ianalumab、Rhapsido 與 HS 的讀出，另外也包括第二期專案 QCZ484 以及 VHB937（ALS）的額外讀出。因此，我認為下半年令人振奮：上半年表現穩健，也期待未來幾個月持續取得進展。

So with that, I'll hand it over to Mukul.

接下來，我把時間交給 Mukul。

Thank you very much, Vas, and good morning, good afternoon, everyone, on the call. I will now share more details on the financials for the second quarter. And as a reminder, my comments as always refer to growth rates in constant currencies unless otherwise noted.

非常感謝你，Vas，各位與會者早安、午安。我現在將分享第二季財務的更多細節。並提醒一下，除非另有說明，我的評論一如往常皆以固定匯率（constant currencies）下的成長率為準。

Turning to slide 18. So in the second quarter, net sales grew 1% to $14.4 billion, while core operating income was flat at $5.9 billion. This is our sales growth drivers and engineered productivity offset the impact of the significant generic erosion that we saw in the first half of this year. The strong performance of Priority Brands supported a return to net sales growth in quarter two faster than we initially expected.

請看第 18 張投影片。第二季淨銷售額成長 1% 至 144 億美元，而核心營業利益持平於 59 億美元。這反映了我們的銷售成長動能與工程化生產力（engineered productivity）抵銷了今年上半年所見的顯著學名藥侵蝕影響。Priority Brands 的強勁表現，支持我們在第二季比原先預期更快回到淨銷售成長。

The second quarter core operating income margin was 41.2 percentage of net sales. This was a decline of 70 basis points versus previous year, mainly due to the incremental ability cost with a lower gross margin being offset by productivity gains. It's worth noting that Q2 is generally a stronger margin quarter when we look at the phasing across the whole year.

第二季核心營業利益率為淨銷售額的 41.2%。較去年下降 70 個基點，主要因為新增的能力成本（capacity cost）與較低的毛利率所致，但部分被生產力提升所抵銷。值得注意的是，若觀察全年各季的分布，第二季通常是毛利率較強的一季。

Free cash flow for the second quarter was at $5.6 billion, which is in line with expectations. Worth to note that Q2 results were also positively impacted by some onetime feeding items, which will reverse in the second half. Together, these items positively impacted net sales by approximately 1 percentage point and core operating income, by about 5 percentage points.

第二季自由現金流為 56 億美元，符合預期。值得注意的是，第二季結果也受到一些一次性（onetime）項目的正面影響，這些影響將在下半年回轉。合計而言，這些項目使淨銷售額約增加 1 個百分點，並使核心營業利益約增加 5 個百分點。

And then for the first half of the year, net sales declined 2%. Core operating income declined 7%, and the core operating margin declined 2.3 percentage points to 39.4%. Free cash flow for the first half of the year stood at $8.9 billion.

而在上半年，淨銷售額下滑 2%。核心營業利益下滑 7%，核心營業利益率下降 2.3 個百分點至 39.4%。上半年自由現金流為 89 億美元。

Turning to slide 19. We remain committed to our shareholder-friendly capital allocation strategy that has served us well as a company, balancing disciplined growth investments in the business with meaningful capital distribution. In Q2, we continue to execute multiple bolt-on M&A and BD transactions, including the completion of the Pikavation and Excellergy acquisitions. At the same time, continue to invest in our internal R&D pipeline.

接著看第 19 頁投影片。我們仍然致力於以股東為導向的資本配置策略；這項策略一直以來都讓公司受益，並在對業務進行有紀律的成長投資與具意義的資本回饋之間取得平衡。在第二季，我們持續執行多項補強型併購（bolt-on M&A）與業務開發（BD）交易，包括完成對 Pikavation 與 Excellergy 的收購。同時，也持續投資於我們內部的研發（R&D）產品線。

Our capital distribution during the first -- on capital distribution during the first half of this year, we paid out $9.1 billion in dividend and repurchased $2.1 billion of shares under the (inaudible) up to $10 billion share buyback program. There is still $5.6 billion to be executed in this program, and we target to complete the program by end of 2027, as previously indicated.

關於今年上半年——關於今年上半年的資本回饋，我們支付了 91 億美元股利，並在（聽不清）最高 100 億美元的庫藏股回購計畫下回購了 21 億美元股票。該計畫仍有 56 億美元尚待執行，我們目標如先前所述於 2027 年底前完成。

Slide 20, please. With this, we are reaffirming our full year 2026 guidance. We continue to expect net sales to grow low single digits and core operating income to decline low single digit for the full year. For the full year 2026, we also continue to expect core net financial result to be around $1.7 billion and core tax rate to be around 16.5%, both in line with our guidance from beginning of the year.

請看第 20 頁投影片。基於此，我們重申 2026 全年財測指引。我們仍預期全年淨銷售額將以低個位數成長，而核心營業利益將以低個位數下滑。對於 2026 全年，我們也仍預期核心淨財務結果約為 17 億美元、核心稅率約為 16.5%，兩者皆與年初提供的指引一致。

Moving to slide 21. As I shared previously, H1 net sales declined 2% and with a strong momentum of growth drivers delivering performance at the upper end of sales guidance from the start of the year. Turning to H2. We continue to expect net sales to grow mid-single digit as we move beyond the impact of US (inaudible).

接著看第 21 頁投影片。如我先前分享，上半年淨銷售額下滑 2%，而成長驅動因素的強勁動能帶動表現落在年初銷售指引的上緣。轉到下半年。隨著我們逐步走出美國（聽不清）影響，我們仍預期淨銷售額將以中個位數成長。

However, it's worth pointing out that there will be a notable difference in the sales growth rates between the two quarters, Q3 and Q4. This is because we still have about $800 million of US Entresto in the sales in previous year quarter three base. We expect H2 core operating income to grow mid- to high single-digit with continued investment in our growth drivers as well as our R&D pipeline.

不過值得指出的是，第三季與第四季兩個季度的銷售成長率將出現明顯差異。原因在於，去年第三季的基期銷售中仍包含約 8 億美元的美國 Entresto。我們預期下半年核心營業利益將以中到高個位數成長，並持續投資於成長驅動因素以及我們的研發產品線。

Slide 22. Finally, if exchange rates remain at mid-July levels, we expect a positive 1 percentage point impact on full year net sales and a positive 1 percentage point impact on core operating income. As a reminder, we published updated FX estimates monthly on our website.

第 22 頁投影片。最後，若匯率維持在 7 月中旬水準，我們預期將對全年淨銷售額帶來正向 1 個百分點的影響，並對核心營業利益帶來正向 1 個百分點的影響。提醒一下，我們每月都會在官網公布更新後的外匯（FX）估計。

That concludes my remarks, and I will hand it back to Vas.

我的發言到此結束，接下來交回給 Vas。

Terrific. Thanks, Mukul. So in closing, we delivered our first half performance at the upper end of guidance with Q2 returning to sales growth. We remain on track to deliver our full year guidance. We're progressing our indications for Rhapsido, Ianalumab, both potential multi-lockbuster assets. And we're focused on our second half pivotal readouts that remain on track. That would allow us to raise our mid- to long-term growth outlook.

太好了。謝謝你，Mukul。總結來說，我們上半年表現落在指引上緣，且第二季重回銷售成長。我們仍按計畫達成全年指引。我們正推進 Rhapsido、Ianalumab 的適應症開發，兩者皆為潛在的多重重磅（multi-blockbuster）資產。同時，我們聚焦於下半年關鍵性（pivotal）讀出，進度仍如期。這將使我們得以上調中長期成長展望。

And with that, we'll open it up to questions.

接下來我們開放提問。

(Operator Instructions) Peter Verdult, BNP Paribas.

（接線員指示）BNP Paribas 的 Peter Verdult。

Peter Verdult, BNP Paribas. I realize there's not much incremental you can say the upcoming Phase III readouts, I heard your comments on Del-brax. So with that in mind, can we focus on the accelerated approval potential for branaplam in Huntington's? I know Phase III planning underway, but do you have any visibility or ballpark timelines you can give us for when FDA might make a decision on whether you can file early on the Phase II data generated thus far?

BNP Paribas 的 Peter Verdult。我知道對於即將公布的第三期（Phase III）讀出，你們能補充的增量資訊不多；我也聽到你們對 Del-brax 的評論。因此在此背景下，我們能否聚焦於 branaplam 在亨丁頓氏症（Huntington's）加速核准的可能性？我知道第三期規劃正在進行，但你們是否能提供一些能見度或大致時程，說明 FDA 何時可能就你們是否能基於目前產出的第二期（Phase II）數據提前申請做出決定？

So we're planning in the process of engaging with the FDA on that Phase II data. I think at this point, our base case remains that we would need to do the Phase III study as designed. So no change on that expectation. I don't have a specific timeline. I would expect it to happen in the second half to provide more clarity.

我們正規劃並正在與 FDA 就該第二期數據進行互動。我認為就目前而言，我們的基本情境仍是需要依照設計完成第三期研究。因此這個預期沒有改變。我沒有具體時間表。我預期會在下半年發生，以提供更清楚的方向。

And I would also note that we continue to follow these Phase II patients for a longer duration as well, which could provide us additional data. We do note the FDA's recent decisions or recent guidances from some of other therapies that are available for -- that could be available for Huntington's disease, which certainly, I think, shows the FDA's openness if the data ultimately is compelling. So we certainly want to have that engagement, but I wouldn't change our base case at this point that a Phase III study would be required.

我也要補充，我們也持續對這些第二期病患進行更長時間的追蹤，這可能為我們提供額外數據。我們也注意到 FDA 近期的決策或針對其他可能用於亨丁頓氏症治療的療法所發布的最新指引；我認為這確實顯示 FDA 的開放態度——前提是最終數據具有說服力。因此我們當然希望進行這樣的互動，但就目前而言，我不會改變我們的基本情境：仍需要第三期研究。

Sachin Jain, Bank of America.

美國銀行（Bank of America）的 Sachin Jain。

So I am going to ask a question on pipe given there's a lot of focus, and it's a kind of catch-all question. So given the change from your communication in and out Ianalumab showrooms on clinically meaningful, just wondering whether you've decided internally how you define clinically meaningful for the 3 reads investors most focused on, so MSDM1. Maybe I just give you a catch, it fair to think that any static benefit is clinically meaningful in your eyes for different reasons for which asset and any changes in level of confidence on each?

我想就產品線（pipeline）問一個問題，因為大家非常關注，這也算是一個涵蓋面較廣的問題。鑑於你們在對外溝通中，對 Ianalumab 的「具臨床意義」（clinically meaningful）表述前後有所變化，我想知道你們內部是否已決定，對投資人最關注的 3 個讀出（MS、DM1、以及……）你們如何定義「具臨床意義」。或許我換個方式問：是否可以理解為，只要有任何靜態（static）改善，在你們看來就屬於具臨床意義——但原因會因資產不同而異？以及對各項目信心程度是否有任何變化？

So no change from previous comments. We don't know anything else that I can provide on any of the 3. I think in terms of how we will read them out, I mean, I think we always focus on the primary endpoint and statistical significance and reaching the goal and the primary endpoint in the study.

與先前評論相比沒有改變。關於這 3 項，我沒有其他可以提供的資訊。至於我們將如何解讀並對外公布，我想我們一向聚焦於主要終點（primary endpoint）、統計顯著性，以及是否達成研究目標與主要終點。

I think certainly -- so that -- I mean, that will guide how we communicate and then as appropriate additional secondary endpoints as well, if appropriate to comment on them. I mean, I think for pelacarsen, as we've guided in the past, we continue to -- we powered the study for the kind of 13% to 15% CVRR benefit. And certainly are hopeful to see that level or higher. And if we can see higher, obviously, we'd prefer that, but I think that's how we think about it.

我認為這——也就是說——將引導我們如何溝通；並在適當情況下，也會視需要評論其他次要終點（secondary endpoints）。以 pelacarsen 而言，如同我們過去所指引的，我們仍將研究設計的統計檢定力（power）設定在約 13% 到 15% 的 CVRR 受益幅度。我們當然希望能看到該水準或更高。若能看到更高，顯然我們會更樂見，但我們的思考方式大致如此。

In MS, we'll certainly be looking at not only the ARR reduction, but also the impact on disability. And clearly, in DM1, in addition to VHA, also want to see some of the secondary endpoints and how they perform as well. But I think the reality is we have to be thoughtful because we want to be able to preserve the ability to present this data at high-profile congresses in the future. So we'll navigate that best we can, making sure investors have clarity on what we believe the path forward is, but still preserving that ability to present the data as well.

在多發性硬化症（MS）方面，我們不僅會看 ARR 的下降，也會看對失能（disability）的影響。而在 DM1 方面，除了 VHA 之外，我們也希望看到一些次要終點的表現。但現實是我們必須審慎，因為我們希望保留未來在高知名度學術會議上發表這些數據的能力。因此我們會盡可能妥善拿捏：一方面確保投資人清楚我們認為的後續路徑，另一方面也保留發表數據的空間。

Can I just take one follow-on on that? So you commented in the answer to the powering of these. I don't think you've ever given us any color on how REIMS or DM1 are powered.

我可以就此再追問一題嗎？你在回答中提到這些研究的統計檢定力設定。我想你們從未就 REIMS 或 DM1 的檢定力設定提供任何細節。

Yes, I don't think we have for either of those. I mean, I think for MS, you all know well how studies that are head-to-head against have been powered in the past. So I think you have that as background. So I don't think there's more that I could provide there. And I think on DM1, primary endpoint is VHA and then we have the various secondary endpoints that we've been discussing with the agency, but I don't think we could provide any further clarity on that one at the moment.

是的，我認為這兩者我們都沒有。我的意思是，我想就 MS 而言，你們都很清楚，過去在與對照藥物進行頭對頭研究時，樣本量/統計效力是如何設定的。所以我想你們可以把這點作為背景。因此我認為我在這方面沒有更多可以補充的。至於 DM1，我們的主要終點是 VHA，然後我們還有一些一直在與主管機關討論的各項次要終點，但我認為目前我們無法就此提供更進一步的明確說明。

Florent Cespedes, ODDO BHF.

Florent Cespedes，ODDO BHF。

Florent Cespedes from ODDO BHF. A quick one for Mukul. Maybe, Mukul, could you give us a little bit more color about the one-off events which impacted the Q2 top line and operating profit margin? Some color on that point would be great.

我是來自 ODDO BHF 的 Florent Cespedes。有個簡短問題想問 Mukul。Mukul，你是否可以再多提供一些細節，說明哪些一次性事件影響了第二季的營收（top line）與營業利益率？如果能就這點補充一些說明會很有幫助。

So the onetime phasing that I mentioned, so we have a 1 percentage point impact on top line. This is primarily inventory-related changes that we saw across the whole world. This would simply move from Q2 to Q3 from an inventory perspective. And then on the cost side, on the R&D phasing side, we have a couple of clinical trial-related costs that have essentially were planned for Q2 and now will move to Q3.

我提到的一次性時點（phasing）因素，對營收有 1 個百分點的影響。這主要是我們在全球各地看到的與庫存相關的變動。就庫存角度而言，這基本上只是從第二季移轉到第三季。另外在成本端、在研發費用時點方面，我們有幾項與臨床試驗相關的成本原本規劃在第二季發生，現在將移到第三季。

If you put both of them together, then on the top line, it's an impact of 1%. And on the bottom line, the cumulative impact of the top line over delivery added or compounded by the cost phasing leads to a 5% impact on the core operating income.

把兩者合併來看，對營收端的影響是 1%。而在獲利端，營收未達（over delivery 的反向）所造成的累積影響，再加上成本時點遞延的疊加效應，導致核心營業利益（core operating income）受到 5% 的影響。

Colin White, UBS.

Colin White，瑞銀（UBS）。

Just to go back to remibrutinib in MS. Please, could you recap specifically what gives you confidence that remibrutinib can improve upon annualized relapse rate of about 0.1 Aubagio has achieved in recent RMS studies?

回到 remibrutinib 在 MS 的問題。請問你能否具體回顧一下，是什麼讓你們有信心 remibrutinib 能夠優於 Aubagio 在近期 RMS 研究中達到的約 0.1 的年化復發率（annualized relapse rate）？

Well, I mean, I think for us, as you know, we don't have Phase II data. So we're basing this based on other BTK inhibitors performance in similar studies. We continue to monitor blinded rates for safety and relapse rates. And I think taken together, that gives us confidence that the study is performing as expected in terms of the differences between the active and the control arm, but not more we can say at this point until we ultimately read out the trial.

嗯，我的意思是，對我們而言，如你所知，我們沒有第二期（Phase II）數據。所以我們是根據其他 BTK 抑制劑在類似研究中的表現來推論。我們也持續監測盲態（blinded）的安全性事件率與復發率。我認為綜合這些因素，讓我們有信心該研究在主動治療組與對照組之間的差異方面，表現符合預期；但在最終讀出試驗結果之前，我們目前無法再多說。

I think for us, clearly, with remibrutinib, in addition to looking at annualized relapse rate and MRI performance, how it performs in disability progression will be important to understand is REMI, something that would be used in a setting post the B-cell antibodies or could it be used in a setting in line or ahead of the B-cell antibodies. And this will all be data driven. And obviously, once we see that data, we'll be able to provide better guidance on that use. But that's probably about as much as we can provide at this point.

對我們來說，顯然就 remibrutinib 而言，除了觀察年化復發率與 MRI 表現之外，它在失能進展（disability progression）方面的表現也將很重要，因為這有助於理解 REMI 是會用在 B 細胞抗體之後的治療情境，還是可以與 B 細胞抗體同線甚至更前線使用。這一切都將由數據來驅動。而且很明顯，一旦我們看到那些數據，就能就其使用情境提供更好的指引。但目前我們大概只能提供到這個程度。

Richard Vosser, JPMorgan.

Richard Vosser，摩根大通（JPMorgan）。

Just another question on pelacarsen. We've seen some other cardiovascular trials recently suffer from high levels of drop-ins of existing therapies. So wondering how you've controlled for that in the HORIZON trial. Just thinking about it in relation to, I suppose, PCSK9s, but also for GLP-1s and SGLT2s given the 25% of patients that are diabetics. So how should we think about that level of use and potentially the impact on any benefits of pelacarsen?

再問一個關於 pelacarsen 的問題。我們最近看到一些其他心血管試驗因既有療法的「加入使用」（drop-ins）比例偏高而受到影響。所以想請問你們在 HORIZON 試驗中如何控制這件事。我想特別是與 PCSK9 抑制劑相關，但也包括 GLP-1 與 SGLT2，因為有 25% 的患者是糖尿病患者。因此我們應該如何看待這些藥物的使用程度，以及其可能對 pelacarsen 任何效益造成的影響？

I mean, it is important to note we study pelacarsen on top of optimized background lipid-lowering therapy. I mean, our current estimate is that the number of patients who were on incretin-based therapies in the study is less than 10%. I mean, we estimate it to be around 6%. So we don't believe that that -- if there was any effect from those medicines in the setting that we wouldn't expect that to impact the results here. So when we look at it, overall, it's as we -- more or less as we planned in terms of background therapy. And so we don't think that will be a major swing factor, at least based on what we can see so far.

我的意思是，重要的是要注意，我們是在最佳化的背景降脂治療（optimized background lipid-lowering therapy）之上研究 pelacarsen。我們目前估計，在研究中使用腸泌素（incretin）相關療法的患者比例低於 10%。我們估計大約是 6%。因此我們不認為——即便那些藥物在此情境下有任何影響——我們也不預期會對本研究結果造成影響。所以整體來看，背景治療的狀況大致符合我們的規劃。因此至少就目前我們所看到的，我們不認為這會是主要的結果擺動因素（major swing factor）。

Go ahead, Richard.

請繼續，Richard。

No, it was just on PCSK9, just one quick follow-up. Was that controlled as well? I know it was 11% at the start, but does that creep up during the trial? Anything you can say?

沒有了，只是關於 PCSK9 的一個快速追問。這部分也有控制嗎？我知道起始時是 11%，但在試驗期間會不會逐步上升？你能說些什麼嗎？

I think with respect to PCSK9, I believe they've also been in line with what we saw earlier in the study, but we could follow up with the details. I know the GLP-1 data for sure, but I don't recall that the PCSK9s are a source of concern either.

我想就 PCSK9 而言，我相信其使用情況也與我們在研究早期看到的水準一致，但我們可以再補充細節。我對 GLP-1 的數據很確定，但我不記得 PCSK9 會是令人擔憂的來源。

Michael Leuchten, Jefferies.

Michael Leuchten，Jefferies。

Question for Mukul, please. The guidance for mid- to high single-digit CER EBIT growth in the second half seems to imply more cost control, especially taking into consideration the Avidity R&D phasing that you just mentioned. Can you talk about the P&L dynamics? Like where are you containing costs? And is that something that we need to take into consideration as we think about '27? Or is that sort of tucking in expenses that will not recur?

想請教 Mukul。你們對下半年以固定匯率（CER）計算的 EBIT 中到高個位數成長指引，似乎意味著會有更多成本控管，特別是考量你剛提到的 Avidity 研發費用時點遞延。你能談談損益表（P&L）的動態嗎？例如你們在哪些地方控制成本？以及當我們思考 2027 年時，是否需要把這點納入考量？還是這只是把某些費用往內收、屬於不會重複發生的項目？

I think from a P&L dynamics perspective, two things I'd say is H1 to H2, we always have from a profitability perspective, from a spend perspective, H2 being a higher spend half. For example, Q2, our profitability finished with 41.2% operating margin. And we know that Q2 is typically the most profitable quarter, so to say. So that part of the dynamic will remain going into this year as well.

我想從損益表動態的角度，有兩點要說：從上半年到下半年，我們一向在獲利與支出上呈現下半年支出較高的型態。例如第二季，我們的獲利表現以 41.2% 的營業利益率作結。而我們也知道第二季通常可以說是最賺錢的一季。因此這部分的動態在今年接下來也會維持。

In terms of where we are working from a productivity perspective, things have been pretty consistent from beginning of the year. Beginning of the year, we said we'll continue our productivity measures when it comes to our manufacturing operations. Operations has done very well. Gross margin would be pressured as the portfolio shift, but productivity should probably -- should help us keep gross margins more or less to where second half last year was on gross margin.

至於我們在生產力（productivity）方面的工作，自年初以來一直相當一致。年初我們就說過，在製造營運方面會持續推動生產力措施。營運團隊做得非常好。雖然產品組合轉移會對毛利率造成壓力，但生產力提升應該——應該能幫助我們把毛利率大致維持在去年下半年的水準。

On R&D, we will continue to invest what the pipeline needs. And this would mean incremental investments this year on the back of Avidity, but also a couple of other assets that we took on, including Tourmaline, Regulus and Anthos last year.

在研發方面，我們會持續投入管線所需要的資源。這意味著今年會因 Avidity 而增加投資，同時也包括我們去年承接的其他幾項資產，例如 Tourmaline、Regulus 與 Anthos。

And then SG&A as a percentage of sales is a place where we believe we, as a company, can do more productive efforts, specifically focused on third-party spend, which is upwards of $10 billion for the company, and that is what we continue to do. As we look at Q2, we actually see while gross margin -- quarter-on-quarter gross margin has been a negative, but SG&A as a percentage of sales has actually been a positive negating that gross margin impact. And that, I would assume, I would think is -- from a prognosis perspective, that is something that we will continue towards the second half of the year.

接著，銷售與管理費用（SG&A）占銷售額的比例，是我們認為公司可以做出更具生產力努力的領域，特別聚焦於第三方支出；對公司而言這部分支出超過100億美元，而這正是我們持續在做的事。當我們看第二季（Q2）時，實際上我們看到雖然毛利率——季對季毛利率是負向的，但SG&A占銷售額的比例其實是正向的，抵銷了毛利率的影響。而我會假設、我認為——從前景的角度來看，這是我們在今年下半年會持續推進的方向。

James Quigley, Goldman Sachs.

James Quigley，高盛。

I've got one on deals and M&A. I think Vas, your quote on Bloomberg as you'd consider larger deals again. So this is a bit of a transition in sort of commentary over the years. A few years back, it was no big deals, then it was focused on bolt-ons, then we had Avidity, which is later stage and a bit larger. So what's changed either internally at Novartis or externally that's driven openness to larger deals? And what could a bigger deal look like in terms of strategic fit given your therapeutic areas and technology set?

我有一題關於交易與併購（M&A）。我想，Vas，你在彭博上的引述提到你們會再次考慮較大型的交易。所以這在多年來的評論上算是一個轉變。幾年前是不要大型交易，接著是聚焦小型補強型收購（bolt-ons），然後我們有了Avidity，屬於較後期、規模也稍大一些。那麼，究竟是諾華內部或外部有什麼改變，促使你們對較大型交易更開放？以及，考量你們的治療領域與技術布局，一筆更大的交易在策略契合度上可能會長什麼樣子？

I don't know what exactly Bloomberg growth, but I can say there's no change in our M&A strategy. We've been, I think, disciplined and consistent that we focus on steady deals in the kind of sub-$2 billion range, which with the upfronts in that range, often lower and then selectively do larger deals in the range of things like Avidity when there is a compelling asset that fits with our -- either our platform strategy or our TA strategy or both and Avidity fit both. So no change at all in our M&A strategy.

我不確定彭博到底怎麼寫的，但我可以說，我們的併購策略沒有改變。我想我們一直很自律且一致地聚焦於穩定的交易，通常在20億美元以下的區間；在這個區間的預付款（upfront）往往更低；然後在有具吸引力、且符合我們——不論是平台策略或治療領域（TA）策略或兩者——的資產時，才會選擇性地做像Avidity這樣較大型的交易，而Avidity兩者都符合。所以我們的併購策略完全沒有改變。

We don't need to do anything larger than that. We have full confidence in our internal portfolio and pipeline and R&D engine. And yet we know we need to constantly supplement that engine with additional external innovation. So you can expect just a continuation of what you've seen over the recent years.

我們不需要做比那更大的事。我們對內部產品組合、研發管線以及研發引擎充滿信心。但我們也知道，需要持續以額外的外部創新來補充這個引擎。所以你可以預期，我們會延續你近年來看到的做法。

Simon Baker, Roth & Co.

Simon Baker，Roth & Co.。

One on the pipeline, if I may, please. I wonder if you could just update us on your thoughts on the confidence and potential for abelacimab. And also, I see that it's still showing us a 2027 readout milestone in the slide deck. Clinical trials is now showing a late December '27 primary completion. So is that still a '27 event? Or is there potential for slippage into 2028?

如果可以的話，我想問一題關於研發管線。想請你更新一下你們對abelacimab的信心與潛力的看法。另外，我看到簡報投影片仍顯示2027年的讀出里程碑。但臨床試驗登錄現在顯示主要完成時間是2027年12月下旬。所以這仍然會是2027年的事件嗎？還是有可能延後到2028年？

So we remain excited about abelacimab. As a reminder, this is a monthly monoclonal antibody that has shown outstanding, I think, overall pharmacokinetics and pharmacodynamics on well, very well-behaved antibody on Factor XI.

我們仍然對abelacimab感到振奮。提醒一下，這是一款每月給藥的單株抗體，我認為它在整體藥物動力學與藥效學方面表現非常出色，是一個在第XI因子（Factor XI）上表現非常「乖」、特性很好的抗體。

We've seen with competitor data that Factor XI appears to deliver on the promise of a very strong anticoagulation without increased bleeding risk, which is what the genetics would indicate for us. And so we have the study ongoing in patients who are ineligible for NOACs. And that study -- we have upsized that study given the event rates that we saw, so you can also see that on clinicaltrials.gov. But we're on track for a readout before the end of the year.

從競品數據我們看到，第XI因子似乎能兌現一個承諾：提供非常強的抗凝效果，同時不增加出血風險——這也正是遺傳學所提示的。因此我們正在對不適用NOACs的患者進行研究。而該研究——基於我們看到的事件發生率，我們已擴大了研究規模；你也可以在clinicaltrials.gov上看到。但我們仍按計畫在年底前取得讀出結果。

That is a readout at 75% of events, just to be clear. And then the study would continue if it's not successful at that point or that doesn't meet the stopping criteria at that point to finish the number of events in 2028. And then we evaluate now or in the process of beginning additional studies in secondary stroke prevention as well as assessing other indications as well. So excited about that opportunity. I think it could be a significant asset if the trials ultimately read out positive.

澄清一下，那是以75%的事件數為基礎的讀出。然後如果在那個時間點不成功，或未達到停止標準，研究將會繼續進行，以在2028年完成所需的事件數。此外，我們也正在評估、或正開始規劃在次級中風預防方面的額外研究，同時也在評估其他適應症。所以我們對這個機會感到興奮。我認為如果試驗最終讀出為正面，它可能會是一項重要資產。

Thibault Boutherin, Morgan Stanley.

Thibault Boutherin，摩根士丹利。

Just a question on (inaudible) that you have launched the drug and we start to see the sales coming in. Do you have any more visibility on what you expect to be the shape of the bolus of sales from this therapy over the next few years? If you have any indication on when you expect the sales to peak? Is it next year? Is it '28?

我想問一題關於（聽不清）你們已經上市這個藥物，且我們開始看到銷售進來。你們是否對未來幾年這項療法銷售「脈衝」的形狀有更多能見度？你們是否有任何指引，何時預期銷售會達到峰值？是明年嗎？還是2028年？

And then on the magnitude, I think in the past, Novartis was talking about multibillion dollar for this asset. So just if you could comment on your confidence on the peak sales here.

另外在規模方面，我記得過去諾華談到這項資產可能是數十億美元級別。所以想請你評論一下你們對這裡峰值銷售的信心。

So no change. I'd say we -- as you know, I just got the European Commission approval. I think in general, with gene therapy, as we learned with Zolgensma, it does take some time to get the reimbursement. But once we get the reimbursement, we see a relatively rapid ramp on the product. So we -- I would say, over the 3-year period is where we would expect to see the ramp on as we get additional countries online. It's also worth noting for -- as with Zolgensma, we expect ex-US to be larger than the US, the same dynamics we saw that with Zolgensma.

所以沒有改變。我會說——如你所知，我們剛獲得歐盟委員會核准。一般而言，基因療法如同我們從Zolgensma學到的，取得給付（reimbursement）需要一些時間。但一旦取得給付，我們會看到產品相對快速的放量成長。因此我會說，在3年的期間內，隨著我們讓更多國家上線，我們預期會看到放量爬坡。另外也值得注意——如同Zolgensma，我們預期美國以外市場會大於美國；這也是我們在Zolgensma上看到的相同動態。

So all on track, but it is important to note this first year will be mostly focused on securing reimbursement. From a peak sales potential, also no change with Zolgensma, we expect the continued steady state in this blockbuster $1 billion-plus territory. and we expect Abema to have a kind of $2 billion range so that the overall package of these 2 medicines have a $3 billion potential.

所以一切都在軌道上，但需要強調的是，第一年將主要聚焦於取得給付。就峰值銷售潛力而言，也沒有改變：如同Zolgensma，我們預期其在「重磅藥」10億美元以上的區間維持穩定態；而我們預期Abema大約在20億美元左右，因此這兩項藥物的整體組合具有約30億美元的潛力。

Steve Scala, TD Cowen.

Steve Scala，TD Cowen。

Vas, you called out Kesimpta in non-US markets as a growth opportunity, but Kesimpta had leadership in 9 of 10 markets in Q4 and Q1 and 8 of 10 markets in Q2 and one difference appears to have been China. So I'm curious what happened with Kesimpta in China in Q2?

Vas，你提到Kesimpta在美國以外市場是成長機會，但Kesimpta在Q4與Q1於10個市場中的9個市場居於領先，而在Q2則是10個市場中的8個市場領先，其中一個差異似乎是中國。所以我很好奇，Kesimpta在中國Q2發生了什麼事？

So no change in China that we're aware of. We did drop off in Italy actually from 9 out of 10 to 8 out of 10. I'd say, in general, Kesimpta does very well in Asia. It's a market leader in Japan, but it is worth noting that multiple sclerosis levels in Asia are significantly lower than what we see in other parts of the world. So the overall sales potential is lower.

就我們所知，中國沒有任何改變。我們其實是在義大利從10個市場中的9個領先，掉到10個市場中的8個。我會說，整體而言，Kesimpta在亞洲表現非常好。它在日本是市場領導者，但值得注意的是，亞洲的多發性硬化症（MS）盛行程度顯著低於我們在世界其他地區看到的水平。因此整體銷售潛力較低。

So -- but I would say, overall, we continue to see significant opportunity outside of the US just simply because the market has not -- the cell therapies have just not adequately penetrated the market outside of the US. So for all B-cell therapies, there's just an opportunity to get more patients on the best possible medicine. And I don't have the details on the Italy shift, but I imagine it's just market share dynamics in a country that we have, of course, other competitors.

所以——但我會說，整體而言，我們仍看到美國以外有顯著機會，原因很單純：細胞療法在美國以外市場的滲透仍不充分。因此對所有B細胞療法而言，都有機會讓更多患者使用到最好的藥物。至於義大利市占變化的細節我沒有掌握，但我想這只是市場份額在一個我們當然也有其他競爭對手的國家中的動態變化。

Seamus Fernandez, Guggenheim Securities.

Seamus Fernandez，Guggenheim Securities。

So I guess the question on our side is just given the substantial valuation increases that we've seen across biotech in the last year, how should we be thinking about the business development opportunities as you see going forward? You talked about the BD focus really being no change, but certainly one change in that mix has been valuation. So just trying to get a better sense of how you're thinking about that and the kind of risk that Novartis needs to take going forward?

所以我想我們這邊的問題是，鑑於過去一年我們在生技領域看到的顯著估值上升，展望未來，您認為我們應該如何看待商務開發（BD）的機會？您提到BD的重點其實沒有改變，但這個組合中確實有一個變化就是估值。所以想更清楚了解您如何思考這點，以及諾華未來需要承擔的風險類型？

And then just a quick question that I wanted to ask on the pelacarsen side of things. It's a composite endpoint. And my recollection was we saw a muted benefit or maybe not muted, but a teens benefit with SGLT2s, but an outsized benefit in the heart failure population on cardiovascular death. how might that kind of an outcome play out? Or do you see that as a potential outcome for pelacarsen as the data reads out in the second half of this year?

另外我想就pelacarsen再快速問一題。這是一個複合終點。我記得我們在SGLT2上看到的效益較為溫和——或許不算溫和，但大概是十幾個百分點的效益——不過在心衰竭族群的心血管死亡上卻看到超出預期的效益。這樣的結果可能會如何呈現？或者您是否認為，當pelacarsen在今年下半年讀出數據時，也可能出現類似的結果？

So I think on valuation, I mean, look, when I reflect over 9 years, I would say that the price of assets that don't have minimal clinical data has gone up quite dramatically. You see now ourselves and our peers doing upfronts that are over $1 billion for assets that have limited or no clinical data, which is, I think, if you took at the long arc of the sector, a significant shift, which I think just means you have to have higher levels of conviction in the science and differentiated, something that you believe is unique and differentiated.

我想就估值而言，我的意思是，回顧這9年，我會說缺乏最低限度臨床數據的資產，其價格已經相當大幅上升。你現在看到我們自己以及同業，對於臨床數據有限或甚至沒有臨床數據的資產，預付款（upfront）就能做到超過10億美元；如果從產業長期趨勢來看，這是一個很顯著的轉變。我認為這代表你必須對科學本身有更高程度的信念，並且要有差異化——也就是你相信它是獨特且具差異化的。

In our case, the 3 deals we did this year with Pikavation, we believe that there is an opportunity to address more of the mutant -- to a pan-mutant kind of approach in PI3 kinase-driven breast cancer with Excellergy to tackle with hopefully a much higher efficacy than historical IgE therapies given the ability to target IgE in a fundamentally different way in the case of Mirix, a novel payload that hopefully has the NMTI payload has a cleaner profile than the topozeimerus payloads. But I think you have to have some sort of differentiated conviction just given that the price levels are climbing.

以我們的情況來說，今年我們與Pikavation做的3筆交易，我們相信在PI3激酶驅動的乳癌上，有機會從更多突變型——走向泛突變（pan-mutant）的策略；與Excellergy的合作，則希望藉由以根本不同的方式鎖定IgE，來處理問題並帶來（相較於過往IgE療法）更高的療效；至於Mirix，則是一種新型payload，我們希望其NMTI payload相較於topozeimerus類payload具有更乾淨的特性。但我認為在價格水準持續攀升的情況下，你必須具備某種差異化的信念。

That said, you have to be able to access external innovation to grow companies of our size. So we have to just keep looking for that right balance of breakthrough science and then finding the right balance from a valuation standpoint.

話雖如此，對於我們這種規模的公司而言，必須能取得外部創新才能成長。因此我們必須持續尋找突破性科學與估值面之間的適當平衡。

Your point on pelacarsen is well taken. I mean, there is an element here of the MACE endpoint versus CV death. Lp(a) is associated with high rates of sudden cardiac death, particularly in younger patients. Very difficult, of course, for us to say without having lock the database and see the data to know exactly. But there is at least the potential for CV death to be an important component, at least theoretically, given the profile of Lp(a), it's something we'll have to look carefully at and how that drives versus other elements of the endpoint.

你對pelacarsen的觀點很到位。我的意思是，這裡確實存在MACE終點相對於心血管死亡（CV death）的因素。Lp(a)與較高的猝死率相關，尤其是在較年輕的病人。當然，在我們尚未鎖定資料庫並看到數據之前，很難確切判斷。但至少在理論上，考量Lp(a)的特性，心血管死亡有可能成為重要組成之一；這是我們必須仔細檢視的，並評估它相對於終點其他要素的驅動程度。

Kerry Holford, Berenberg.

Kerry Holford，Berenberg。

Question from me on Kisqali, just on the IP, the extension that you've been granted related to pediatric exclusivity. Can you confirm now that that conduct matter expiry is May 2032? And in the context of your earlier settlements with generic players, is that when we should now be assuming generic market entry?

我想問Kisqali的問題，主要是關於智慧財產權（IP），也就是你們因兒科獨占（pediatric exclusivity）而獲准的延長。你能否確認現在該物質專利（composition of matter）的到期日是2032年5月？並且在你們先前與學名藥廠達成和解的背景下，我們是否應該假設學名藥將在那個時間點進入市場？

So our guidance is second half 2031, so Q3 2031 guidance for LOE for Kisqali with the pediatric exclusivity, and that's inclusive of the settlements that we have with generic manufacturers. And just as a quick note as well, we double checked in China for Kesimpta, we have 70% market share and are market leader as well.

我們的指引是2031年下半年，也就是針對Kisqali在兒科獨占下的專利到期（LOE）指引為2031年第三季；這也已包含我們與學名藥製造商達成的和解內容。另外補充一點，我們也再次確認了中國的Kesimpta，我們有70%的市占率，同時也是市場領導者。

Emmanuel Papadakis, Deutsche Bank.

Emmanuel Papadakis，德意志銀行。

Maybe I'll take one on Ianalumab and Sjogren's. Given we must be relatively late in the regulatory review process, could you perhaps just give us an update on how that's proceeding? Is everything on track? And are you expecting a panel?

我可能先問一題關於Ianalumab與乾燥症（Sjogren's）。鑑於監管審查流程應該已相對接近尾聲，您能否更新一下目前進展如何？一切都在軌道上嗎？以及你們是否預期會有專家諮詢委員會（panel）？

And then on commercial readiness, some sense of expectations for magnitude of initial access, breadth and willingness to prescribe, et cetera. Could you just give us a sense in those parameters? Should we be looking at something like classic immunology launch like Cosentyx -- or are there other things -- other analogs which perhaps bear in mind?

另外關於商業化準備（commercial readiness），能否談談對於初期給付准入規模、覆蓋廣度、以及醫師開立意願等的預期？能否就這些參數給我們一些概念？我們應該把它視為像Cosentyx那樣典型的免疫學上市節奏——還是有其他需要參考的類比案例？

Thanks, Emmanuel. So again, as far as we know, no advisory committee planned for Ianalumab. We've had the mid-cycle review meetings. And so we're continuing to provide FDA all the information they're requesting. So all on track from that point for Q3 approval.

謝謝你，Emmanuel。就我們所知，Ianalumab目前沒有規劃召開諮詢委員會。我們已經完成期中審查（mid-cycle review）會議。因此我們持續向FDA提供他們所要求的所有資訊。所以就這一點而言，一切都在軌道上，目標仍是第三季核准。

I think from a market uptake standpoint, our current expectation is given that there's no approved therapy in Sjogren's, we should get relatively broad access with all the caveats that this does take time to get the environment opened up. And then we think that physicians, given that the drug has a clean safety profile, will err on the side of trialing the drug in patients and ultimately seeing how patients respond.

我想從市場導入（market uptake）的角度來看，我們目前的預期是：由於乾燥症尚無已核准療法，我們應能取得相對廣泛的准入；當然也要附帶所有但書，因為要讓整個環境打開仍需要時間。此外我們認為，鑑於該藥物具有乾淨的安全性特徵，醫師會傾向先在病人身上試用，並最終觀察病人的反應。

I mean, this is a very heterogeneous patient population. Even the STI endpoint is covering a broad range of domains. And we do see in our own data sets, there are patients who are super responders and patients who respond less well. And so we're, I think, going to see in the marketplace for patients who respond, they'll stay on medicine and other patients will cycle off.

我的意思是，這是一個非常異質的病人族群。即便STI終點也涵蓋了相當廣泛的領域。而在我們自己的資料集中也看到，有些病人是超級反應者（super responders），也有些病人的反應較不理想。因此我想在市場上會看到：對於有反應的病人，他們會持續用藥；而其他病人則會停止並更換治療。

But I think the key thing here is we have a clean safety profile, which lowers the, I think, bar for physicians to at least give patients the option given the nature of disease. These are young -- often young female patients in working age who obviously want better control of their symptoms of their disease. So we're optimistic on that front as well.

但我認為關鍵在於我們有乾淨的安全性特徵，這降低了醫師至少讓病人有機會嘗試的門檻，考量到疾病本身的特性。這些病人多半是年輕——往往是工作年齡的年輕女性——她們顯然希望能更好地控制疾病症狀。所以在這方面我們也同樣樂觀。

We continue to guide that stand-alone in Sjogren's, we should reach a multimillionpdollar potential. And then as I mentioned in my opening comments, Ianalumab has a number of other indications that we're also pursuing, both in hematology and in immunology.

我們仍維持指引：Ianalumab若以乾燥症單一適應症（stand-alone）來看，應可達到數十億美元的潛力。另外如我在開場提到的，Ianalumab還有多個其他適應症正在推進，涵蓋血液學與免疫學兩個領域。

Graham Parry, Citigroup.

Graham Parry，花旗集團。

So on pelacarsen, a quick follow-up, actually, just you clarified the 13% to 15% is what the trial is minimally powered to detect. I think you said it was just what it was powered for, but I think the design paper says it's 20% on all comers. And would you view that 13% to 15% as a clinically meaningful result? So that was a follow-up. And then on REMS, could you just comment on your confidence in achieving disability progression, perhaps talk to the brain penetration of the molecule and action of the microglia compared to remibrutinib, which actually didn't show that with statistical significance in its Phase III.

關於pelacarsen，我想快速追問一下：你剛剛澄清13%到15%是試驗在最低限度上有把握偵測到的效果大小。我記得你說那就是它的統計把握度所對應的數值，但我想設計論文寫的是在所有受試者（all comers）上為20%。那你會把13%到15%視為具有臨床意義的結果嗎？這是追問。另外關於REMS，你能否評論一下你們對於達成失能進展（disability progression）終點的信心？也許談談分子進入腦部的能力，以及相較於remibrutinib對小膠質細胞（microglia）的作用；因為remibrutinib在其第三期試驗中並未以統計顯著性顯示出那一點。

So you are correct. 13 to 15 would mean a win. It's powered for 20% for the patients who are 70 milligrams in DL and above or 25% for the 90-milligram DL and above. And so I think we would say in the mid-teens is clinically meaningful given that these patients have no other option and that this is an independent risk factor. And so yes, we'll ultimately see what the data shows.

所以你說得沒錯。13 到 15 代表會是一次勝利。對於 LDL 為 70 毫克/分升及以上的患者，研究設計有 20% 的檢出力；對於 LDL 為 90 毫克/分升及以上的患者，則有 25% 的檢出力。因此我認為，在十幾%的中段（mid-teens）在臨床上是有意義的，因為這些患者沒有其他選擇，而且這是一個獨立的風險因子。所以是的，我們最終會看數據顯示什麼。

And then with respect to REMI and MS, I think we have -- everything indicates to us that the trial is being conducted and the data that we're seeing that from an ARR standpoint that we're on track versus what we would have expected in the data set. As you know, with disability progression, we have no way to know. And I think it's very difficult for me to handicap that.

接著關於 REMI 和 MS，我認為我們——所有跡象都顯示試驗正在按計畫進行，而且從我們看到的數據來看，就 ARR 的角度而言，我們的進度符合我們在該數據集下原本的預期。如你所知，至於失能進展，我們沒有辦法知道。而且我認為要我去預判這件事是非常困難的。

We saw the data with remibrutinib, we do believe that our molecule is more potent on the target and more selective. And so we're hopeful that that leads to the improvements in disability progression that would bring us in line with the antibody-based B cell therapies. But there's no way for us to assess that in any sort of objective way at this point until the study reads out.

我們看過 remibrutinib 的數據，我們確實相信我們的分子在靶點上更具效力、也更具選擇性。因此我們希望這能帶來失能進展方面的改善，使我們能與以抗體為基礎的 B 細胞療法看齊。但在研究讀出結果之前，我們目前沒有任何客觀方式可以評估這一點。

Rajesh Kumar, HSBC.

Rajesh Kumar，匯豐（HSBC）。

One question for Mukul. Thanks for clarifying what sort of cost cuts is going forward. Just -- if we are thinking through the P&L on margins, the gross margin level we have now sort of captured most of the interest or negative impact. Should we sort of expect this to be the level from which you can build based on when you get growth from younger products in the portfolio, while you get the profit growth through SG&A management and R&D phasing, obviously, growth in the second half. So just in terms of gross margin trough point, should we be thinking about now or later in the year?

有一個問題想問 Mukul。謝謝你釐清未來會進行哪些成本削減。只是——如果我們從損益表角度思考利潤率，我們目前的毛利率水準似乎已經反映了大部分的利息或負面影響。那我們是否可以預期，這會是你們未來可以在此基礎上往上建立的水準——隨著產品組合中較年輕產品帶來成長，同時透過 SG&A 管理與研發費用時點安排來帶動獲利成長，當然還有下半年成長。所以就毛利率的谷底而言，我們應該認為是現在，還是今年稍晚？

Thanks for the question, Rajesh. So I think gross margin, we already said we had this discussion beginning of the year, and I think it's -- the point on the gross margin where we are now is a good point to take from modeling for the future. And what we already said is end of last year, Q3, Q4 of last year, if you take an average of that that should be the gross margin point that we take.

謝謝你的問題，Rajesh。我認為毛利率方面，我們年初已經討論過；而我認為我們目前的毛利率水準，是未來建模時一個不錯的參考點。我們之前也說過，如果你取去年年底、也就是去年 Q3、Q4 的平均值，那應該就是我們要採用的毛利率基準點。

But worth saying is that gross margin would never be flat. It depends on the profit mix that we have from a quarter-on-quarter perspective. And as we move the portfolio forward, there are pushes and pulls that we have in our portfolio. We've got a great drug if comes to life like remibrutinib, a small molecule. We don't have any royalties versus some of our other portfolio where the gross margins would be more stretched. But I think from a modeling perspective, I would take the year-to-date gross margin as a good indicator of what to expect for year to go.

但也值得一提的是，毛利率不會是持平不變的。它取決於我們每季之間的獲利組合。隨著我們推進產品組合，組合內會有一些拉扯因素。如果像 remibrutinib 這樣的藥物成功上市，那是一個小分子藥。相較於我們產品組合中的其他一些產品，我們不需要支付權利金，因此毛利率壓力會比較小；而其他產品的毛利率可能會被拉得更緊。但從建模角度，我會把年初至今的毛利率視為今年剩餘期間的良好指標。

Florent Cespedes, ODDO BHF.

Florent Cespedes，ODDO BHF。

A question on the cardio business. Assuming positive results on pelacarsen later this year and positive Leqvio outcome trials next year, will you have to use either new sales force? Or will you use an existing sales force that will be the one on Leqvio be Leqvio? Some color also on the budget going forward, will you have to invest massively on marketing to promote the new exciting clinical results?

關於心血管業務的一個問題。假設今年稍晚 pelacarsen 結果為正面、以及明年 Leqvio 的結果性試驗（outcome trials）為正面，你們是否需要使用新的銷售團隊？還是會使用既有的銷售團隊——也就是目前負責 Leqvio 的團隊來推 Leqvio？另外也想請你們談談未來的預算：你們是否需要在行銷上大幅投資，以推動這些令人振奮的新臨床結果？

I think at the moment, we would expect that with for pelacarsen that we will be able to leverage the existing global Leqvio field force that we have. Of course, usual adjustments that we might need to make. And I think the overall, any investments that would be required for the pelacarsen launch, particularly around disease awareness to get additional patients tested for Lp(a) levels, we would be able to -- is all factored into the guidance that we've been giving on margin progression.

我認為就目前而言，我們預期 pelacarsen 將能夠運用我們現有的 Leqvio 全球外勤銷售團隊。當然，可能需要做一些常規的調整。而我認為 pelacarsen 上市所需的任何投資——特別是疾病認知（disease awareness）方面，以促使更多患者接受 Lp(a) 濃度檢測——我們都能夠……而且這些都已納入我們對利潤率改善所提供的指引之中。

I think as we've noted in the past, it will take time to drive up these biomarker testing rates. But we're hopeful that with a drug that has an attractive efficacy that will motivate physicians to test and ultimately patients to get on therapy.

我想如同我們過去提到的，提高這些生物標記檢測率需要時間。但我們希望，若有一款療效具吸引力的藥物，將能促使醫師進行檢測，並最終讓患者接受治療。

I think for elsewhere in the cardiovascular portfolio, obviously, with abelacimab as well as the Phase III program we'll be running with our anti-IL-6 recently acquired medicine as well. Those might require additional field force investments. And we'll, of course, provide any guidance on that once we get those Phase III results and have a better read on those -- because those obviously go to different physician segments, both for anticoagulation and in the case of the anti-IL-6 pibecatug would be for physicians who are treating in the more acute coronary setting.

至於心血管產品組合的其他部分，顯然包括 abelacimab，以及我們近期收購的抗 IL-6 藥物也將進行的第 III 期計畫。這些可能需要額外的外勤銷售團隊投資。當我們取得那些第 III 期結果、並對其有更清楚的判讀後，當然也會就此提供相關指引——因為這些產品面向的醫師族群不同：一方面是抗凝治療領域；而抗 IL-6 的 pibecatug 則是針對在較急性冠狀動脈情境中治療的醫師。

Colin White, UBS.

Colin White，瑞銀（UBS）。

Colin White from UBS. Just on the stocking in the quarter, I understand the 1% of sales beat was from stocking. Cosete explained some of this, but not all of it. So are you able to provide any color on what other drugs may have experienced stocking?

我是瑞銀的 Colin White。關於本季的鋪貨（stocking），我理解銷售額超預期的 1% 來自鋪貨。Cosete 解釋了其中一部分，但不是全部。所以你們能否提供一些說明：還有哪些其他藥品可能也出現了鋪貨？

Colin, this was no particular brand I would call out on stocking. I think this was across the board. It was not just in one single geography, but multiple geographies. And I would not attribute this to a specific drug destocking.

Colin，這次鋪貨沒有任何特定品牌是我會特別點名的。我認為這是全面性的。不只發生在單一地理區域，而是多個地區。而且我不會把這歸因於某一特定藥品的去庫存（destocking）。

And maybe just to provide a little bit of color as well. I mean, this was related to the implementation of our new SAP system, where it's often the case when we roll that out in multiple geographies, we do have to shift ship stocking levels for the cutover to the new SAP system. So that's the driver and the reason why it's not associated with one brand per se.

另外也許再補充一點說明。這與我們新 SAP 系統的導入有關；通常當我們在多個地區推行時，為了切換到新 SAP 系統，我們確實需要調整出貨與庫存水位。所以這就是驅動因素，也就是為什麼它並非與某一個品牌特別相關。

Michael Leuchten, Jefferies.

Michael Leuchten，Jefferies。

Vas, interested in your Scemblix comment about the second half aiming for NBRx leadership in the US. Is that just natural progression of the dynamics that we're seeing? Or is there a pivot point that would inflect that further?

Vas，我對你提到 Scemblix 在下半年目標是在美國取得 NBRx 領先地位的評論很感興趣。這只是我們目前看到的動態自然推進的結果嗎？還是有某個轉折點會讓它進一步加速？

I think, yes, it's just the momentum we're seeing. I also think that now we've gotten very strong access position for the brand. And so I think that stronger access position as it flows through. I mean, one of the things with CML is because it is a rare disease, and there's a limited number of newly diagnosed patients in a given year, it just takes time. And so any of the smaller fluctuations that you see quarter-on-quarter is driven by very few patients.

我認為，是的，這就是我們看到的動能。我也認為我們現在已經為這個品牌取得非常強的給付/准入（access）地位。因此，隨著更強的准入地位逐步反映出來。我的意思是，CML 的其中一個特點是它屬於罕見疾病，而每年新診斷患者數量有限，所以需要時間。因此你看到的任何季度間較小的波動，都是由非常少數的患者所驅動。

But all indications we're seeing is that given the very strong safety profile that physicians are seeing with the drug and obviously, the known efficacy profile, there's just a lot of momentum now. So that gives us confidence that we'll get to that market leadership position in the US.

但我們目前看到的所有跡象都顯示，鑑於醫師在該藥物上看到非常強勁的安全性概況，且顯然其已知的療效概況也很明確，現在確實有很大的動能。因此，這讓我們有信心能在美國達到市場領導地位。

And I mean, I'll flag again, I mentioned in my opening comments that we're really just at the beginning now of moving from third line to first line ex US. And I think one of the things that's been a positive trend as well, there are multiple generic medicines available in that first-line setting. There seems to be a strong demand from physicians, but also payers are accepting the fact that Scemblix has demonstrated that it is a superior medicine in that frontline setting and more openness to give us the reimbursement we would expect for such a medicine.

而且我再強調一次，我在開場評論中提到，我們在美國以外的市場，現在其實才剛開始從三線治療往一線治療推進。我認為另一個正向趨勢是，在一線治療情境中有多種學名藥可用。醫師端似乎有強勁需求，同時付款方也正在接受這個事實：Scemblix 已證明在一線治療情境中是更優越的藥物，因此也更願意提供我們對此類藥物所預期的給付水準。

James Quigley, Goldman Sachs.

James Quigley，高盛。

So I think earlier this year, Lutathera generics were cleared to launch by the courts in Delaware. So I think a small impact overall on the sales perspective. But how should we think about potential launches for future generic RLTs? We don't have an experience here, obviously, when thinking about generic impacts for RLTs and Novartis clearly has a number of competitive advantages, but how are you thinking the markets could react? Or how could this play out if and when we see generic RLTs launching?

所以我想今年稍早，Lutathera 的學名藥已由德拉瓦州法院裁定可獲准上市。因此我認為從銷售角度看，整體影響不大。但我們應該如何看待未來其他學名藥 RLT 的潛在上市？我們顯然沒有這方面的經驗，尤其是在思考 RLT 的學名藥衝擊時；而諾華顯然具備多項競爭優勢，但你們如何看待市場可能的反應？或者當我們看到學名藥 RLT 上市（若/何時發生）時，可能會如何演變？

So we -- as far as we know, neither of the 2 companies has received an FDA approval. One is a 505(b)(2) and one is a generic. We continue to believe there needs to be a high threshold used by regulators to ensure that the same dose of radiation is being delivered to the tumor versus the originator brand that we have. Now that being said, we do believe that given our extensive network of supply and our ability to deliver on time in full to physicians across the globe, but also across the United States, we impact from a generic launch even with a lower price being brought into the market.

就我們所知，這兩家公司都尚未取得 FDA 核准。其中一個是 505(b)(2)，另一個是學名藥。我們仍然相信，監管機關需要採用很高的門檻，以確保其向腫瘤所遞送的放射線劑量與我們的原廠品牌一致。話雖如此，我們確實相信，憑藉我們廣泛的供應網絡，以及我們在全球、也包括在美國能夠準時且足量交付給醫師的能力，即使有較低價格的學名藥進入市場，我們也能降低其上市所帶來的影響。

We think that RLT will behave very differently than either small molecule and potentially biosimilars just for biologics, just given the logistical complexity and as well as the expectation that physicians have that the medicine is delivered on time each time given the nature of the logistics for the office. So we feel confident on that. From that said, we're not -- we continue to work to keep bringing better medicines, not only with the case of PSMA and prostate cancer, but we also have follow-on efforts as well for GRPR and really trying to improve the treatment for neuroendocrine tumors as well, follow-ons for lutathera. So stay tuned on that front as well.

我們認為，RLT 的市場表現會與小分子藥物、以及可能的生物相似藥（針對生物製劑）非常不同，主要是因為其物流複雜性，以及醫師對於藥品必須每次都準時送達的期待，這與診所端的物流特性有關。因此我們對此很有信心。此外，我們也會持續努力推出更好的藥物，不僅是在 PSMA 與前列腺癌方面，我們也有後續的研發工作，包括 GRPR，以及真正想改善神經內分泌腫瘤的治療，同時也有 Lutathera 的後續產品。所以這方面也請持續關注。

Urban Fritsche, ZKB.

Urban Fritsche，ZKB。

A question on Leqvio in China. Maybe if you could share some details on how the momentum is developing and what would be needed to really have upside to your current guidance of, I guess, it's $1 billion in China alone.

關於 Leqvio 在中國的一個問題。也許你可以分享一些動能發展的細節，以及要如何才能真正超越你們目前的指引——我猜是光中國就有 10 億美元。

So with Leqvio, we initially saw a very strong uptake in launch in the private self-based segment, which I think really indicates there's a high demand for the medicine in the secondary prevention, but importantly as well in the primary prevention setting as well from a self-based standpoint. And then what -- I think what we've seen is very strong performance now in -- once we had the NRDL listing, we see that both in the hospital segment and in the traditional segments as well, a very strong performance.

就 Leqvio 而言，我們在上市初期於自費的私立市場區隔看到非常強勁的採用，我認為這清楚顯示該藥物在次級預防上有很高需求；同樣重要的是，從自費角度看，在初級預防情境也有需求。接著我們看到的是——我認為目前在納入 NRDL 之後，我們在醫院端以及傳統通路端都看到非常強勁的表現。

So I think seeing that continued steady growth should get us to it being our largest medicine potentially that we've ever delivered in China. Entresto gives us a very strong benchmark in China, but we think Leqvio has the potential as well. And I think really, it depends now on the dynamics on the growth as we try to continue to expand into additional hospitals into additional regions.

因此，我認為只要持續看到穩健成長，就能讓它成為我們在中國可能有史以來交付的最大產品。Entresto 在中國為我們提供了非常強的標竿，但我們認為 Leqvio 也具備這樣的潛力。而我認為接下來主要取決於成長動能的變化，因為我們會持續擴展到更多醫院、更多地區。

I would say as well, we look now to also bring additional siRNAs into the China market rapidly. We think there's an opportunity in cardiovascular hypertension and CVR risk reduction for our follow-on siRNAs in China, where there seems to be a high demand for infrequently administered therapies with very clean safety profiles. And I think that gives us a bigger opportunity in China in the longer term for that cardiovascular siRNA portfolio.

我也想說，我們現在也希望能快速把更多 siRNA 帶入中國市場。我們認為在心血管、高血壓以及 CVR 風險降低方面，我們的後續 siRNA 在中國有機會，因為市場似乎對於低頻給藥、且安全性概況非常乾淨的療法有很高需求。我認為這也讓我們在更長期的中國市場，對於這個心血管 siRNA 產品組合有更大的機會。

Steve Scala, TD Cowen.

Steve Scala，TD Cowen。

Were there any surprises in the label or the pricing of the oral PCSK9 inhibitor recently approved that alter Novartis' view of the commercial potential for Leqvio? And Vas is a very skilled and experienced drug developer, any thoughts on how limiting the fasting ultimately will be?

最近獲批的口服 PCSK9 抑制劑，其標籤或定價是否有任何意外，進而改變諾華對 Leqvio 商業潛力的看法？另外 Vas 是非常有能力且經驗豐富的藥物開發者，對於最終「禁食」要求會有多大限制性，你有什麼看法？

So I think no surprises other than the reference to the PCSK9 outcomes trials. So I think we're trying to understand that given that usually we don't get to refer to somebody else's outcome studies. And I think with respect to the -- other than that, nothing that changes our view.

我認為沒有任何意外，除了提到 PCSK9 的結局試驗。因此我們正在理解這一點，因為通常我們不會被允許引用別人的結局研究。除此之外，沒有任何會改變我們看法的事情。

I mean, look, our belief is that there's a significant segment of the market -- and this is a huge market and the number of patients who are not at goal for lipid lowering to reach their lipid targets is significant in the United States. We're talking about here a 70 million patient segment overall and a significant portion of these patients who are not at goal. And so I think the opportunity for the PCSK9 is -- for these advanced lipid-lowering therapies is significant.

我的意思是，我們相信市場中有一個相當大的區隔——而這是一個非常龐大的市場——在美國，未達到降脂目標、無法達成其血脂控制目標的患者數量相當可觀。我們談的是整體約 7,000 萬名患者的族群，其中相當一部分未達標。因此我認為 PCSK9——也就是這些進階降脂療法——的機會相當大。

And we see that there's ongoing demand for patients who want infrequently administered therapies and physicians who want to provide the therapy as well in the physician-administered setting. So I think the fact that we are not participating in the gross to net battle that will ensue between the monoclonal antibodies and the orals actually are in a segment that's insulated from that, I think, gives us a strong position in the longer run for our goal of a $4 billion to $5 billion plus product.

我們也看到，對於希望低頻給藥的患者，以及希望在由醫師施打的情境中提供治療的醫師而言，需求仍在持續。因此我認為，我們沒有參與單株抗體與口服藥之間即將展開的「毛利到淨額（gross-to-net）」價格戰，反而處在一個能夠隔離於該競爭之外的區隔；我認為這讓我們在長期上，朝向 40 億到 50 億美元以上產品目標時，具備強勢地位。

Now with respect to the food effect, I think it remains to be seen. I mean, I think clearly, an 8-hour fast plus the 30 -- I think it's a 30-minute or so post fast in this particular drug. But I think we'll have to see because, obviously, patients can find ways to manage that. And I would say there are other competitors coming that as far as we understand, may not have the food effect. So given that, I think we just have to focus on our segment and focus on the patients that we can reach in that Part B buy-and-bill setting in the US.

至於食物影響，我認為仍有待觀察。我的意思是，很明顯，這個藥物需要 8 小時禁食，再加上 30——我想大約 30 分鐘左右的餐後等待期。但我想我們還得再看，因為患者顯然可以找到方式來管理這件事。我也想說，據我們了解，還有其他競品正在開發中，可能不會有食物影響。因此，基於這些因素，我們只需要專注在我們的區隔，並專注於我們在美國 Part B「先買後付（buy-and-bill）」給付模式下能觸及的患者。

I do want to pitch again outside of the US, particularly in Asia, we see very strong uptake for siRNAs. And we think that in some -- it's a very country-by-country situation as to what kind of profile people are looking for in the medicines. And at least in Asia and Middle East, we see high demand for siRNAs that gives us a lot of confidence.

我也想再次強調，在美國以外，特別是在亞洲，我們看到 siRNA 的採用非常強勁。而且我們認為，在某些方面，各國對藥物所期待的特性是逐國不同的情況。至少在亞洲與中東，我們看到對 siRNA 的高需求，這讓我們非常有信心。

Sachin Jain, Bank of America.

Sachin Jain，美國銀行。

I just had one on FSHD. In your introductory comments, you referenced ongoing analysis looking at correlating CDOs to outcomes and that you would use that for the conversation with the regulator. So I guess two linked questions. One, will you comment on that data when you have it? And b, what conversations have you had with the regulator around using that analysis to try and accelerate the biomarker-driven file?

我只有一個關於 FSHD 的問題。在您的開場評論中，您提到正在進行的分析，旨在檢視 CDO 與臨床結果之間的相關性，並且您會用這些結果來與監管機關溝通。所以我想有兩個相互連結的問題。第一，當您拿到資料後，會對外評論/分享嗎？第二，您與監管機關就使用該分析、以嘗試加速以生物標記驅動的申報，已經進行了哪些對話？

So we have the previous interactions that Avidity had with the -- with FDA on what would be required in this Phase Ib, Phase II study to enable filing. So we're very clear on what the FDA is looking for. And I mean, if you think about it, the way the FDA thinks about this is we know that DUX4 is impacted in this disease. How is circulating KHDLC correlating with DUX, how is that relating to creatine kinase, and how is all of this relating ultimately to function and muscle function as best as we can determine in the patient set that we have. So we have that data. We're analyzing the biopsy data that we have as well from the patients in the trial and then putting that all together to take it to the FDA.

我們已經掌握 Avidity 先前與 FDA 就本次第 Ib 期/第 II 期研究需要達成哪些要求、才能支持申報所進行的互動內容。因此，我們非常清楚 FDA 在尋找什麼。而且如果你仔細想，FDA 看待這件事的方式是：我們知道 DUX4 在這個疾病中受到影響。循環中的 KHDLC 與 DUX 的相關性如何？這又如何與肌酸激酶（creatine kinase）相關？而這一切最終又如何與功能、以及肌肉功能相關——在我們現有的受試者族群中，我們會盡可能去判斷。所以我們有這些資料。我們也正在分析試驗患者的活檢資料，然後把所有資料整合起來，帶去與 FDA 討論。

What I can say is the data that we've seen thus far gives us we believe we have reason to have the discussion with the FDA and to make the case. We can't guarantee that we will win the case, but I think we have what we think is worthy of a case that should be made to the FDA for an accelerated filing. And once we have that meeting, we'll provide further guidance.

我能說的是，截至目前我們看到的資料讓我們相信，我們有理由與 FDA 進行討論並提出論點。我們無法保證一定能說服對方，但我認為我們確實有一個值得向 FDA 提出的案例，以支持加速申報。一旦我們完成那場會議，我們會提供進一步的指引。

Peter Verdult, BNP Paribas.

Peter Verdult，法國巴黎銀行（BNP Paribas）。

A quick one to end for Mukul. Just on -- the IQVIA trends look great. I heard your comments earlier about don't expect an inflection. But can you help us at all giving us a ballpark split between what is bridged versus paid prescriptions right now? Just any ballpark numbers would be helpful.

最後一個簡短問題給 Mukul。關於 IQVIA 的趨勢看起來非常好。我也聽到您先前提到不要期待出現拐點。但您能否協助我們，大致提供一下目前「橋接」處方與「付費」處方的比例拆分？任何大概的數字都會有幫助。

Mukul or is it you asking me or -- so I think -- well, I can take that, Peter, with addressing Mukul. But on Rhapsido, yes, we're not providing any detailed guidance on the bridging program. What I would say is it's in line with what we've historically seen in terms of getting patients over to paid scripts, I think now for Rhapsido, it's really just a story of step-by-step continuing to drive up the access environment.

Mukul——你是在問我嗎，還是——我想——好，我可以回答這個問題，Peter，同時也回應 Mukul。但就 Rhapsido 而言，是的，我們不會就橋接計畫提供任何細部指引。我想說的是，這與我們過去看到的情況一致，也就是把病人轉換到付費處方的進展；我認為對 Rhapsido 來說，現在其實就是一步一步持續改善可近性環境的故事。

I mean, we see strong demand, very strong demand in the dermatology segment. We're working on building stronger demand as well in the allergy segment. In general, once physicians start using the medicine and they get the feedback from the patients that they're seeing disease improvement within hours and certainly within a week, that gives a very compelling case to continued use. But we're trying to stay really disciplined on the gross to nets here.

我的意思是，我們看到強勁的需求，在皮膚科領域的需求非常強。我們也在努力於過敏領域建立更強的需求。一般而言，一旦醫師開始使用這個藥物，並從病人那裡得到回饋——他們在數小時內、且肯定在一週內就能看到疾病改善——這就形成了非常有說服力的理由來持續使用。但我們也在總收入到淨收入（gross-to-net）方面保持高度紀律。

We just believe that if we play the long run out here, remibrutinib has the potential to be used in a broad range of indications, as you all well know. And any points we give now, we won't be able to get back in the future. And so we're just being very thoughtful. And so I think the access will improve sequentially over the course of this year, but that will ultimately set us up, I think, for a strong 2027 and then a strong longer-term outlook for remibrutinib in the future.

我們只是相信，若以長期來看，remibrutinib 有潛力用於廣泛的適應症範圍，這點各位都很清楚。而我們現在給出去的任何讓步，未來都不可能再拿回來。因此我們會非常審慎。所以我認為，今年在可近性方面會逐季改善，而這最終將讓我們——我想——在 2027 年有強勁表現，並為 remibrutinib 未來更長期的展望奠定良好基礎。

I will now hand the call back to you, Vas.

我現在把電話交回給你，Vas。

Absolutely. And I just wanted to come back to Richard Vosser's question. We can confirm that the use was just modestly increased versus the 11% from the baseline population. So not a significant factor we expect in the studies. But thanks for that question, Richard.

當然。我也想回到 Richard Vosser 的問題。我們可以確認，相較於基線族群的 11%，使用率只是小幅增加。因此我們預期這不會在研究中成為顯著因素。不過仍謝謝你的提問，Richard。

So thanks, everyone, for joining today's conference call. So we look forward to keeping you up to speed as we have the readouts over the coming months and of course, catching up with you in various settings in the meantime, and we look forward to a strong second half and wish you all a great summer break as well. Thank you.

那麼，感謝各位參加今天的電話會議。未來幾個月隨著我們陸續取得讀出結果，我們也期待持續向各位更新進度；同時在此期間也會在不同場合與各位交流。我們期待下半年表現強勁，也祝各位有個愉快的暑假休息時光。謝謝。

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

謝謝。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。