Novartis AG (NVS) 2025 Q2 法說會逐字稿

Good morning and good afternoon,, and welcome to the Novartis Q2 2025 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，歡迎參加諾華 2025 年第二季業績發布電話會議和現場網路直播。（操作員指令）。會議正在錄製中。（操作員指令）。電話會議結束後不久，我們的網站上將會提供電話會議的錄音，包括問答環節。

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

接下來，我想將發言權交給投資人關係主管史隆辛普森女士。女士，請繼續。

Thank you, Sharon. Good morning and good afternoon, everyone, and welcome to our Q2 2025 earnings call.

謝謝你，莎倫。大家早安，下午好，歡迎參加我們的 2025 年第二季財報電話會議。

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 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.

今天提供的資訊包含前瞻性陳述，涉及已知和未知的風險、不確定性和其他因素。這些可能導致實際結果與此類聲明表達或暗示的任何未來結果、績效或成就有重大差異。有關這些因素的描述，請參閱分別向美國證券交易委員會提交的 20-F 表和 6-K 表上的最新季度結果。

Before we get started, I just want to reiterate what Sharon said, please limit yourselves to 1 question at a time, and we'll cycle through the queue as many times as we need to. And with that, I'll hand across to Vas.

在我們開始之前，我只想重申 Sharon 所說的話，請限制自己每次只問一個問題，我們會根據需要循環提問多次。說完這些，我就把麥克風交給 Vas。

Great. Thanks, Sloan, and thanks, everybody, for joining today's conference call. If we move to slide 4, as you saw earlier today, Novartis delivered another strong quarter. We had double-digit sales growth, core margin expansion, and this supported an upgrade to our full year 2025 bottom line guidance. Sales were up 11% in constant currency.

偉大的。謝謝斯隆，也謝謝大家參加今天的電話會議。如果我們翻到幻燈片 4，正如您今天早些時候看到的，諾華又取得了強勁的季度業績。我們的銷售額實現了兩位數成長，核心利潤率擴大，這支持了我們上調 2025 年全年獲利預期。以固定匯率計算，銷售額成長了 11%。

Core operating income was up 21% in constant currency.

以固定匯率計算，核心營業收入成長了 21%。

And we also had important innovation highlights in the quarter, many of which I'll cover in the subsequent slides. Two, I wanted to highlight here, OAV-101 IT, we had submissions in the US and Europe. And we also had important milestones reached on Votoplam in Huntington's disease as well as a few others, which I'll cover.

本季我們還有一些重要的創新亮點，我將在後續投影片中介紹其中的許多內容。第二，我想在這裡強調一下，OAV-101 IT，我們在美國和歐洲都有提交。我們在 Votoplam 治療亨廷頓舞蹈症以及其他一些疾病方面也取得了重要的里程碑，我將對此進行介紹。

Our core operating income guidance was upgraded and Harry will cover that in a bit more detail.

我們的核心營業收入指引已上調，Harry 將對此進行更詳細的介紹。

So moving to slide 5. Our priority brands continued to drive robust growth, demonstrating the replacement power in our portfolio. Brands -- these brands were up 30% in constant currencies. Excluding Entresto, the portfolio is up 33%. I think some of the highlights for us included Kisqali, Kesimpta, Scemblix, Leqvio also with a strong quarter, Pluvicto as well as

現在轉到投影片 5。我們的優先品牌持續保持強勁成長，彰顯了我們產品組合的替代能力。品牌—以固定匯率計算，這些品牌的價值上漲了 30%。不包括 Entresto，該投資組合上漲了 33%。我認為我們關注的一些亮點包括 Kisqali、Kesimpta、Scemblix、Leqvio（季度表現強勁）、Pluvicto 以及

So moving to slide 6. Kisqali grew 64% in the quarter, and we achieved TRx leadership in metastatic breast cancer and very importantly, built strong momentum in the early stages now of our early breast cancer launch. You can see robust growth globally, but very strong growth in the US with that EBC launch. In terms of total brand NBRx, you can see here in the middle panel, we are now the market leader across all of the stages of the disease.

現在轉到投影片 6。Kisqali 本季成長了 64%，我們在轉移性乳癌領域取得了 TRx 的領先地位，而且非常重要的是，在我們早期乳癌產品的推出初期就建立了強勁勢頭。您可以看到全球範圍內的強勁成長，但隨著 EBC 的推出，美國的成長非常強勁。就整個品牌 NBRx 而言，您可以在中間面板看到，我們現在是該疾病所有階段的市場領導者。

And going by geography, in the US, we were up 100% in quarter 2. We have metastatic breast cancer leadership in both NBRx and TRx now, which I think is really encouraging. On the early breast cancer side of things, our NBRx share now has reached 61% with leadership in both the overlapping as well as the exclusive populations to Kisqali.

從地理來看，在美國，我們第二季的銷售額成長了 100%。目前，我們在 NBRx 和 TRx 轉移性乳癌治療領域均處於領先地位，我認為這確實令人鼓舞。在早期乳癌方面，我們的 NBRx 份額現已達到 61%，在與 Kisqali 重疊的人群和專屬人群中均處於領先地位。

Outside of the United States, we were up 25%. We've achieved metastatic breast cancer leadership in NBRx and TRx. The early breast cancer indication is now approved in Europe, China and 18 other countries. And our first launch markets, I think, have shown us some really positive signals. They're following the US

在美國以外，我們的成長了 25%。我們在 NBRx 和 TRx 治療轉移性乳癌方面取得了領先地位。目前，該藥物用於治療早期乳癌已獲得歐洲、中國和其他 18 個國家的批准。我認為，我們首次推出的市場已經向我們展示了一些非常正面的訊號。他們正在追隨美國

trajectory.

彈道。

Our Germany early breast cancer NBRx share is at 71%, and that also has supported strong performance in our metastatic breast cancer share as well in Germany.

我們在德國早期乳癌 NBRx 的份額為 71%，這也支持了我們在德國轉移性乳癌份額的強勁表現。

Now as you know, we have strong guidelines support Category 1 preferred NCCN guidelines, the only CDK4/6 with the highest ESMO scores. So I think altogether, this really puts together a nice story for Kisqali to continue to be one of the key growth drivers for Novartis through the next decade.

現在如您所知，我們擁有強有力的指導方針支援第 1 類首選 NCCN 指南，即唯一具有最高 ESMO 評分的 CDK4/6。所以我認為總的來說，這確實為 Kisqali 在未來十年繼續成為諾華的關鍵成長動力之一奠定了良好的基礎。

Now moving to the next slide. Kesimpta grew 33% in the quarter, and this was fueled by the continued strong demand growth we see for a self-administered B-cell therapy for MS -- in the US, we were up 28%. We had TRx growth with 23%. We're seeing access improvements translating to fewer bridge and more direct to paid starts, which I think is really encouraging.

現在轉到下一張投影片。Kesimpta 本季成長了 33%，這得益於我們看到的針對 MS 的自我管理 B 細胞療法的持續強勁需求成長——在美國，我們的成長了 28%。我們的 TRx 成長了 23%。我們看到訪問改進轉化為更少的橋樑和更多的直接付費開始，我認為這真的令人鼓舞。

Our opportunity still remains the 50% of patients that are still on low-efficacy therapies. Really, in the US, our goal is to expand the use of B cell therapies and then within the B-cell class continue to gain additional NBRx and TRx share.

我們的機會仍然是那些仍在接受低療效治療的 50% 的患者。實際上，在美國，我們的目標是擴大 B 細胞療法的使用，然後在 B 細胞類中繼續獲得額外的 NBRx 和 TRx 份額。

Now outside of the US, strong growth as well, we're leading in NBRx share in 8 out of 10 of our major markets. Many of these markets prefer self-administered B-cell therapies. But here as well, we see a significant opportunity for further growth. We estimate that 70% of patients in Europe on disease-modifying treatments are not treated with B-cell therapies. So this clearly shows there's an opportunity to really expand the use of B-cell therapies and particularly Kesimpta.

現在，在美國以外，我們也實現了強勁成長，在 10 個主要市場中的 8 個，我們的 NBRx 份額處於領先地位。許多市場更傾向於自我管理的 B 細胞療法。但在這裡，我們也看到了進一步成長的巨大機會。我們估計，歐洲接受疾病改良治療的患者中有 70% 並未接受 B 細胞療法治療。因此，這清楚地表明有機會真正擴大 B 細胞療法（尤其是 Kesimpta）的使用。

So moving to slide 8. The 1 important milestone for us in the quarter was Pluvicto returned to really, I think, robust growth, which I think bodes well for Pluvicto as well as our more broadly our RLT franchise. It was up 30% on the quarter. It's driven by the pre-taxane indication approval in the US That launch is off to a strong start.

請移至投影片 8。本季對我們來說最重要的里程碑是 Pluvicto 恢復了真正強勁的成長，我認為這對 Pluvicto 以及我們更廣泛的 RLT 特許經營來說都是好兆頭。本季成長了 30%。這是受到美國紫杉烷類藥物適應症批准的推動，該產品的上市開局強勁。

We saw significant quarter-on-quarter growth, 40% in new patient starts.

我們看到了顯著的季度環比增長，新患者數量增長了 40%。

Sales were up 25%. We had a record high number of patient starts in June, and that was expected given that we have about a 4- to 7-week treatment lifetime from approval and patients being introduced to the therapy and then actually coming on to the therapy based on all the testing required.

銷售額成長了25%。6 月我們開始治療的患者數量創下了歷史新高，這是意料之中的，因為從獲得批准、患者開始接受治療，到根據所有必要的測試真正開始接受治療，我們的治療週期大約為 4 到 7 週。

Now the success factors for us in the US, both in the near term and long term are increasingly getting put in place. We're seeing strong uptake in the community setting, a 60% NBRx quarter-on-quarter growth in the community, 58% TRx in quarter 2. We estimate that 9 out of 10 patients are now within 30 miles of a treatment site with over 670 sites active.

現在，我們在美國取得短期和長期成功的因素正在日益顯現。我們看到社區環境中出現了強勁的成長勢頭，社區中的 NBRx 環比增長了 60%，TRx 在第二季度增長了 58%。我們估計，目前每 10 名患者中就有 9 名位於距離治療點 30 英里以內，共有超過 670 個活躍的治療點。

And we see -- we've seen 40% growth in the number of sites over the last year. We believe we have the right footprint now maybe with some limited additions and really now we're focusing on driving additional depth in these sites, particularly within the urology setting where we see strong uptake as well as, I think, targeted expansion in certain regions.

我們看到—去年站點數量增加了 40%。我們相信，現在我們擁有正確的足跡，也許只需進行一些有限的補充，而現在我們真正關注的是推動這些站點的進一步深入，特別是在泌尿科領域，我們看到了強勁的增長勢頭，而且我認為，在某些地區也有針對性的擴張。

We also saw over 50% of PSMAfore patients were with HCPs who had previously used Pluvicto in the VISION setting. I think shows as well that as we gain experience with VISION with PSMAfore that will surely support the PSMAddition launch and then future RLPs in the future years.

我們也發現超過 50% 的 PSMAfore 患者的 HCP 之前曾在 VISION 環境中使用過 Pluvicto。我認為這也表明，隨著我們在 PSMAfore 上獲得 VISION 經驗，這必將支持 PSMAddition 的推出以及未來幾年的 RLP。

And then lastly, our ex-US growth continues in the VISION setting. Our growth was driven by Europe, where we're expanding the level of reimbursement in our key markets.

最後，我們的美國以外地區的成長在 VISION 設定中持續。我們的成長主要受到歐洲的推動，我們正在歐洲主要市場擴大報銷水準。

So another word on Pluvicto on slide 9. We had, earlier in the quarter, the positive Phase III PSMAddition study, which we believe will pave the way now for further expansion in metastatic hormone-sensitive prostate cancer. In the study from a top line standpoint, our primary endpoint was met statistically significant and clinically meaningful benefit in radiographic PFS.

因此第 9 張投影片上還有另一句關於 Pluvicto 的說法。本季度早些時候，我們進行了積極的 III 期 PSMAddition 研究，我們相信這將為轉移性荷爾蒙敏感性前列腺癌的進一步擴展鋪平道路。從頂線角度來看，在這項研究中，我們的主要終點是在放射學 PFS 方面達到了統計學上顯著且有臨床意義的益處。

We saw a strong positive trend in overall survival, and that will continue to mature over time. And that data will be presented at an upcoming Medical Congress. Now for context, we estimate that the incidence of HSPC is very much comparable to CRPC, though there is additional competition in the HSPC space.

我們看到整體存活率呈現強勁的正面趨勢，隨著時間的推移，這種趨勢將持續成熟。該數據將在即將召開的醫學大會上公佈。現在就背景而言，我們估計 HSPC 的發生率與 CRPC 非常相似，儘管 HSPC 領域存在額外的競爭。

And as I mentioned in the previous slide, what will be absolutely critical is our breadth now that we've achieved in community oncology and urology, which will support both PSMAfore and PSMAddition.

正如我在上一張投影片中提到的，絕對關鍵的是我們現在在社區腫瘤學和泌尿學領域所取得的成就，這將支持 PSMAfore 和 PSMAddition。

So based on the FDA feedback that we've received, our submission is planned in the second half. We would plan to provide FDA the final rPFS analysis during the review as well as an updated OS at that time point. But I think we feel like we're on a very solid track to get an approval now in 2026 for Pluvicto in this setting.

因此，根據我們收到的 FDA 回饋，我們計劃在下半年提交。我們計劃在審查期間向 FDA 提供最終的 rPFS 分析以及當時更新的 OS。但我認為，在這種情況下，我們感覺我們現在處於非常穩固的軌道上，預計在 2026 年獲得 Pluvicto 的批准。

Moving to slide 10. Leqvio grew 61% in the quarter, and we're on track now to exceed $1 billion in sales. In the US, our growth was 47%, and we outpaced the lipid-lowering market. our monthly TRx was at 56% versus a market of 35%. We're seeing more and more depth in our key priority health systems.

移至投影片 10。Leqvio 本季成長了 61%，我們的銷售額預計將超過 10 億美元。在美國，我們的成長率為 47%，並且超過了降脂市場。我們的月度 TRx 為 56%，而市場為 35%。我們看到，我們的重點優先衛生系統正在變得越來越深入。

These health systems we've been working on for many years to really expand the use of Leqvio as a way to manage cholesterol in their patient base.

多年來，我們一直致力於這些醫療系統，以真正擴大 Leqvio 的使用範圍，將其作為管理患者膽固醇的一種方法。

And we also are seeing a strong performance in the post-event patient population. We have new data from the inception study, and we've also seen some updated guidelines which support us in after acute coronary syndromes. And we see this patient population and this group of physicians really interested in optimizing lipid lowering and particularly the use of Leqvio.

我們也看到事件發生後患者群體表現強勁。我們從初始研究中獲得了新的數據，我們還看到了一些支持我們治療急性冠狀動脈綜合徵的更新指南。我們發現這個患者群體和這群醫生確實對優化降脂，特別是使用 Leqvio 很感興趣。

Now interestingly, you can see here as well that we've had very strong performance outside of the US, 74% growth in constant currencies. It's driven broadly across the markets where we are approved, but particularly in China, where we see the continued out-of-pocket market expansion.

有趣的是，您還可以看到，我們在美國以外的表現非常強勁，以固定匯率計算成長了 74%。它在我們獲得批准的市場中得到廣泛推動，尤其是在中國，我們看到自付費用市場持續擴張。

So our goal will be to continue to build the evidence base. Our pediatric submission is underway. Our global V-MONO trial is to be presented at EAS, and we continue to look to expand Leqvio's use in the monotherapy frontline setting.

因此我們的目標是繼續建立證據基礎。我們的兒科提交正在進行中。我們的全球 V-MONO 試驗將在 EAS 上展示，我們將繼續尋求擴大 Leqvio 在單一療法一線環境中的使用。

And then we also will present the V-INCEPTION data as well at -- was recently presented as well as the recent Medical Congress.

然後，我們也將在最近舉行的醫學大會上展示 V-INCEPTION 數據。

So moving to slide 11. Now turning to Scemblix, where we are now in the first phase of our launch in the frontline setting. We saw 79% constant currency growth. We're on track to see the $1 billion in sales as well in Scemblix this year. We see the really strong momentum in early lines, which we'll go through, and continue to have global leadership in the third line setting.

現在轉到投影片 11。現在轉向 Scemblix，我們目前正處於前線設定發布的第一階段。我們看到了79%的固定貨幣成長率。我們預計在今年實現 Scemblix 10 億美元的銷售額。我們看到早期產品線的強勁勢頭，我們將繼續在第三線領域保持全球領先地位。

When you look at the middle panel here, you can see that from an NBRx share standpoint, across all lines of therapy, now Scemblix is the most widely used TKI in CML, which I think is really a testament to the strength of the data and the profile of this medicine.

當您查看此處的中間面板時，您可以看到，從 NBRx 份額的角度來看，在所有治療方法中，Scemblix 現在都是 CML 中使用最廣泛的 TKI，我認為這確實證明了數據的強度和這種藥物的特性。

And then on the first-line setting, at the bottom half of the panel, you can see we've already reached 15% NBRx share, and we're working hard to drive that up now rapidly over the coming quarters. Overall, we've achieved NBRx leadership, as I mentioned, across all lines of therapy outside of the -- in the US, outside of the US, third line leadership and increasing early line approvals.

然後在第一行設定中，在面板的下半部分，您可以看到我們已經達到了 15% 的 NBRx 份額，並且我們正在努力在未來幾個季度內迅速提高這一份額。總體而言，正如我所提到的，我們在美國以外的所有治療領域、美國以外的第三線領導地位以及不斷增加的早期線批准方面都取得了 NBRx 領導地位。

We have 48% total share in our key markets now ex-US And we see early line indications now coming online. We're approved in 20 countries, including China and Japan. We also continue to expand the evidence base so that hematologists know they have the data to cover all relevant CML patients. Recent data for either have been presented or will be presented and I think build out the overall portfolio of data for this medicine.

目前，我們在美國以外主要市場佔有 48% 的份額，我們看到早期生產線跡象正在顯現。我們已獲得中國和日本等 20 個國家的批准。我們也將繼續擴大證據基礎，讓血液學家知道他們擁有涵蓋所有相關 CML 患者的數據。已經呈現或將要呈現的最新數據，我認為可以建構出這種藥物的整體數據組合。

Now moving to slide 12. Now Cosentyx growth moderated to 6% in quarter 2, though we continue to expect mid-single-digit growth for the full year. When you look at it from a US perspective, we saw solid demand for our launches in the US, both HS and IV. HS continued to grow with 70% of the business from naive patients.

現在轉到投影片 12。目前，Cosentyx 的成長率在第二季放緩至 6%，但我們仍預計全年將實現中等個位數的成長。從美國的角度來看，我們發現美國對我們推出的 HS 和 IV 的產品有強勁的需求。HS 業務持續成長，其中 70% 的業務來自初治病患。

And we continue to have leading NBRx share with 52% share in naive first patient and 48% overall. In the IV setting, we've seen continued steady growth as well with 17% volume growth quarter-on-quarter.

我們繼續保持 NBRx 的領先地位，在初治首例患者中的份額為 52%，總體份額為 48%。在 IV 設定中，我們也看到了持續的穩定成長，季增了 17%。

What we are seeing as well as we remain competitive in our core indications, psoriasis and AS and PSA. In the US, we're the number one IL-17 prescribed across indications, and that's supported by a long history of strong access. And outside of the US, we're the leading originator biologic in both Europe and China.

我們看到，我們在核心適應症牛皮癬、僵直性脊椎炎和前列腺特異性抗原 (PSA) 方面仍然保持競爭力。在美國，我們是各類適應症中處方量最大的 IL-17 藥物，這得益於我們長期以來強大的市場覆蓋能力。除美國外，我們也是歐洲和中國領先的生物製劑原創企業。

Now that said, we are facing some geographic specific short-term headwinds. In the US, we did see higher RDs in 340B and as part of the Medicare Part D redesign in the first half of the year. We do have a new competitor entry in HS, which is impacting us, particularly for switches off of Cosentyx.

話雖如此，我們正面臨一些特定地理區域的短期阻力。在美國，我們確實看到 340B 中的 RD 有所提高，並且作為上半年 Medicare Part D 重新設計的一部分。HS 領域確實出現了新的競爭對手，這對我們產生了影響，特別是對於 Cosentyx 的關閉。

And it is worth noting that we did have strong launch performance in the prior year as well as a positive RD effect as well. And all of that is contributing to the slowdown we see right now in the US growth.

值得注意的是，我們在前一年確實取得了強勁的發布業績以及積極的研發效果。所有這些都導致了我們目前看到的美國經濟成長放緩。

Outside of the US, we see pricing impacts from the new indications. So as we bring the HS indication online, as is normal, we do have a price reset in certain markets, and then we grow off of that new price. And we've also seen a market-wide slowdown in China. Now all of that said, we fully expect to be able to maintain mid-single-digit plus growth over the coming years and remain fully confident in our $8 billion-plus peak sales guidance for Cosentyx in 2029.

在美國以外，我們看到了新適應症對定價的影響。因此，當我們將 HS 指示上線時，正如正常情況一樣，我們確實會在某些市場重置價格，然後我們會根據新價格進行成長。我們也看到中國整個市場都在放緩。綜上所述，我們完全有信心在未來幾年內能夠維持中等個位數以上的成長，並對 2029 年 Cosentyx 的 80 億美元以上的高峰銷售預期充滿信心。

Now moving to slide 13. Now turning to Entresto. We continue to see solid growth for this medicine, which I think has just been consistent now for many, many, many years. did want to provide an update on the US situation.

現在轉到投影片 13。現在轉向 Entresto。我們繼續看到這種藥物的穩健增長，我認為這種增長已經持續了很多年了。確實想提供有關美國情況的最新消息。

We fully met our expectation of a US mid-2025 LOE from a financial planning assumption standpoint. Our IP and regulatory litigation is continuing against a single generic company who we have not settled with yet and who is currently enjoined from any launch.

從財務規劃假設的角度來看，我們完全實現了對美國 2025 年中期 LOE 的預期。我們仍在針對一家仿製藥公司進行智慧財產權和監管訴訟，我們尚未與該公司達成和解，該公司目前被禁止推出任何產品。

And so that is in place any later launch prior to the final outcome of these litigations would be at risk because we continue to prosecute our various cases that are ongoing. And so we'll continue to monitor the situation. If we have any material updates, I will certainly provide them, and we'll certainly see now how the courts rule in our various cases over the coming weeks and coming months.

因此，在這些訴訟的最終結果出來之前，任何後續的啟動都將面臨風險，因為我們將繼續審理正在進行的各種案件。因此我們將繼續關注局勢。如果我們有任何重大更新，我一定會提供，而且我們當然會在未來幾週和幾個月內看到法院對我們的各種案件作出何種裁決。

And then outside of the US, we have continued strong guideline position, and we have balanced geographic sales. So it's important to note that in this brand, half of our sales are coming from Europe, China and Japan. And then in Europe, we're protected through November 2026 and continue to look at ways to extend IP beyond that. And in Japan out to 2030, also looking for additional protection there as well.

在美國以外，我們繼續保持強大的指導地位，並實現地理銷售的平衡。因此值得注意的是，這個品牌的銷售額有一半來自歐洲、中國和日本。然後在歐洲，我們的保護期將持續到 2026 年 11 月，我們將繼續尋找方法將 IP 保護期延長至更久。到 2030 年，日本也將尋求額外的保護。

So Entresto will continue to be outside of the US, an important contributor to Novartis growth through the end of the decade.

因此，Entresto 將繼續在美國以外銷售，並將成為諾華公司未來十年成長的重要貢獻者。

Now moving to slide 14. Now turning to our renal portfolio now where we have 3 medicines either launched or in the pipeline. We're excited to see the progress we have on our ongoing launches as well as some new long-term data on zigakibart, our anti-APRIL antibodies.

現在轉到投影片 14。現在轉向我們的腎臟產品組合，其中我們有 3 種藥物已經上市或正在研發中。我們很高興看到我們正在進行的發布會所取得的進展以及有關 zigakibart（我們的抗 APRIL 抗體）的一些新的長期數據。

First, with Fabhalta, we saw steady growth in the US, high persistency and compliance with this oral therapy. We see a good recognition that this is a medicine that's aligned for patients with persistent proteinuria and glomerular inflammation.

首先，我們看到 Fabhalta 在美國實現了穩定成長，這種口服療法具有很高的持久性和依從性。我們看到了良好的認可，這是一種針對持續性蛋白尿和腎小球發炎患者的藥物。

And then C3G as well as seeing positive early launch signals, reflecting a high unmet need, and now we're approved in over 30 countries, including in Japan.

然後，C3G 也看到了積極的早期發布訊號，反映出大量未滿足的需求，現在我們已在包括日本在內的 30 多個國家獲得批准。

Now Vanrafia, our endothelium receptor antagonist. Important to note here, we're seeing very strong HCP feedback, positive feedback, given that we have no REMS, and we are seen as a seamless oral add-on to the current supportive care -- standard of care.

現在是 Vanrafia，我們的內皮受體拮抗劑。值得注意的是，鑑於我們沒有 REMS，我們看到了非常強烈的 HCP 回饋，正面的回饋，並且我們被視為當前支持性護理（護理標準）的無縫口服附加物。

We're also seeing that we're exceeding our early targets for patient enrollment, and we've had solid early access wins in the first few months now since launching. And then lastly, with zikakibart, we announced 100-week data from our ongoing Phase II trial with 40 patients, which represents the longest duration of treatment for any anti-APRIL antibody to date.

我們還發現，我們已經超越了早期的患者招募目標，並且自推出以來的頭幾個月裡，我們已經取得了穩固的早期訪問勝利。最後，我們公佈了 zikakibart 的 100 週 II 期試驗數據，該試驗正在進行，共有 40 名患者參與，這是迄今為止抗 APRIL 抗體治療持續時間最長的一次。

In this trial, we showed clinically meaningful proteinuria reduction of 60% sustained eGFR stabilization and no AEs leading to treatment discontinuation. So the BEYOND Phase III study is on track and nearly completed recruitment now, and we have a readout expected in the first half of 2026, which would give us our third medicine potentially for patients with IgAN and related conditions.

在本次試驗中，我們顯示出具有臨床意義的蛋白尿減少 60% 持續 eGFR 穩定，並且沒有導致停止治療的不良反應。因此，BEYOND 第三階段研究正在按計劃進行，目前招募工作已接近完成，我們預計將在 2026 年上半年獲得結果，這將為我們提供第三種可能用於治療 IgAN 及相關疾病患者的藥物。

Moving to slide 15. We're also announcing today that remibrutinib demonstrated a clinically meaningful and significant benefit in our Phase II study in patients with food allergy. Here, the primary endpoint was met with patients tolerating a greater than 600-milligram peanut protein challenge at week 4.

移至投影片 15。我們今天也宣布，瑞布替尼在我們針對食物過敏患者的 II 期研究中表現出了具有臨床意義的顯著益處。在這裡，主要終點是患者在第 4 週耐受超過 600 毫克的花生蛋白質挑戰。

We also saw safety results, which were consistent with the overall safety profile of remibrutinib. And just to take a step back, we see food allergy as a significant opportunity and one in need for effective oral options. Food allergy represents -- has a global prevalence of 3% to 8%. It is over a $10 billion global market today.

我們也看到了安全性結果，這與瑞布替尼的整體安全性一致。退一步來說，我們認為食物過敏是一個重大機會，需要有效的口服治療方法。食物過敏的全球盛行率為 3% 至 8%。如今，全球市場規模已超過 100 億美元。

Allergen avoidance is seen as burdensome and unreliable. And generally speaking, I would say, current treatment options are limited. So to have remibrutinib that's potentially the first oral allergen agnostic treatment with a rapid onset of action could be really attractive for patients and physicians.

避免過敏原被認為是繁重且不可靠的。總的來說，我認為目前的治療選擇是有限的。因此，瑞布替尼可能是第一種能夠快速起效的口服過敏原無關治療藥物，對患者和醫生來說可能非常有吸引力。

So on the right-hand side, you can see the design of the study, we'll present the full results at an upcoming Medical Congress. And our Phase III planning is well underway to advance this therapy as quickly as possible and build on remibrutinib in CSU, Phase III now ongoing Phase III, as you know, in multiple sclerosis and myasthenia gravis and now food allergy as well. So really an opportunity here to build out this medicine in a significant way.

因此，在右側，您可以看到研究的設計，我們將在即將舉行的醫學會議上展示完整的結果。我們的 III 期計畫正在順利進行中，以盡快推進這種療法，並在 CSU 中以瑞布替尼為基礎，目前正處於 III 期臨床試驗階段，正如您所知，該試驗針對的是多發性硬化症和重症肌無力，現在也針對食物過敏。因此這確實是一個以重要方式開發這種藥物的機會。

So moving to slide 16. In the quarter, we also did present our interim Phase I/II data on YTB, our rapid CART for immune reset in a range of immunological diseases. But here in this study in severe refractory SLE. So you can see on the left-hand side, the composite endpoint of the SLEDAI-2K total score. You can see that we had a very strong result that was persistent and consistent out to 1 year.

請移至第 16 張投影片。在本季度，我們也公佈了 YTB 的 I/II 期中期數據，YTB 是我們用於治療一系列免疫疾病的免疫重置的快速 CART。但本研究針對的是嚴重難治性 SLE。因此您可以在左側看到 SLEDAI-2K 總分的綜合終點。您可以看到，我們取得了非常強勁的成果，而這項成果在一年內一直保持持續且一致。

That improvement in overall disease activity, I think, is very compelling. And the safety overall was in line with what we see overall with our card experience.

我認為，整體疾病活動的改善非常引人注目。整體安全性與我們的刷卡體驗一致。

It's important to know we're quite rigorous in monitoring these patients and logging how we use IVIg and IL-6. And I think in our estimation, this is very consistent with what we see in our experience with managing CAR-T patients.

重要的是要知道我們對這些患者的監測以及記錄我們如何使用 IVIg 和 IL-6 非常嚴格。我認為，根據我們的估計，這與我們在管理 CAR-T 患者方面的經驗非常一致。

And then I think very compelling, you can see on the right-hand side, that screening these patients had multiple systemic manifestations of the disease. And you can see when you get out to the a 12-month time point, you can see again that we have resolved most deficiency broad resolutions other than in proteinuria, which is likely due given how severe these patients are and how refractory they are to ongoing kidney damage that can't be recovered. So remarkable results. And because of the strength of these results, we feel confident now in our broad program, which you see on the next slide, slide 17, where we're advancing YTB in a range of autoimmune diseases.

然後我認為非常引人注目的是，您可以在右側看到，篩選出的這些患者有該疾病的多種全身表現。您可以看到，當您到達 12 個月的時間點時，您可以再次看到，除了蛋白尿之外，我們已經解決了大多數缺陷廣泛的解決方案，這可能是因為這些患者的病情非常嚴重，並且他們對無法恢復的持續腎臟損害具有抵抗力。成果非常顯著。由於這些結果的強勁表現，我們現在對我們的廣泛計劃充滿信心，您可以在下一張投影片（第 17 張）中看到，我們正在推進 YTB 在一系列自體免疫疾病中的應用。

You can see here 7-plus ongoing programs. So you can see both a Phase I/II and the Phase II in lupus and lupus nephritis, that's a pivotal study aligned with FDA systemic sclerosis, also pivotal study; myositis, also a pivotal study; as well as AAV, also a pivotal study.

您可以在這裡看到 7 多個正在進行的專案。因此，您可以看到狼瘡和狼瘡性腎炎的 I/II 期和 II 期研究，這是一項與 FDA 系統性硬化症一致的關鍵研究，也是一項關鍵研究；肌炎，也是一項關鍵研究；以及 AAV，也是一項關鍵研究。

And then we also have early stage programs to look at refractory RA and Sjogren's disease as a basket study as well as programs in relapsing MS, progressive MS and myasthenia gravis. So our hope is to use this YTB as our first foray and strong foray into immune reset using a cell therapy.

然後，我們還有早期項目，將難治性 RA 和乾燥症作為一攬子研究，以及復發性 MS、進行性 MS 和重症肌無力的項目。因此，我們希望利用這次 YTB 作為我們利用細胞療法進行免疫重置的首次嘗試和強有力的嘗試。

And then behind this, we have a number of programs that look at bispecific antibodies and other approaches to achieve immune reset. It's a very exciting data, and we look forward to keeping you updated.

在此背後，我們開展了一系列項目，研究雙特異性抗體和其他方法來實現免疫重置。這是非常令人興奮的數據，我們期待向您提供最新更新資訊。

So moving to slide 18. So overall, our key innovation milestones are broadly on track. We're on track for the quarter 3 readout of ianilumab in Sjogren's disease that we don't have either studies, data in-house as of yet. And we continue to progress our other programs on track as well.

請移至第 18 張投影片。整體而言，我們的關鍵創新里程碑基本上進展順利。我們正按計畫進行 Ianilumab 在乾燥症治療的第三季讀數，但目前我們還沒有內部研究數據。我們的其他項目也將繼續穩步推進。

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

因此，讓我把它交給哈利。

Yes. Thank you, Vas. Good morning, good afternoon, everybody. I'll now talk you through our financials for the second quarter and the first half, which reflects continued strong performance of our growth drivers and overall portfolio. As always, my comments refer to growth rates in constant currencies, unless otherwise noted.

是的。謝謝你，瓦斯。大家早安，下午好。現在我將向大家介紹我們第二季和上半年的財務狀況，這反映了我們的成長動力和整體投資組合持續強勁的表現。像往常一樣，我的評論指的是以固定貨幣計算的成長率，除非另有說明。

So starting on slide 20. Net sales grew plus 11% in quarter 2 per year, and core operating income grew 21%. Our core margin was 42.2%, reflecting a 340 basis point improvement, and core EPS was $2.42, up 24%. And cash flow was even $6.3 billion, up 37% in US dollars.

從第 20 張投影片開始。第二季淨銷售額年增 11%，核心營業收入成長 21%。我們的核心利潤率為 42.2%，提高了 340 個基點，核心每股收益為 2.42 美元，成長 24%。現金流更是達到了63億美元，以美元計算成長了37%。

And then for the first half, also reflecting a very strong growth momentum with sales up plus 13% and core operating income up 24%. Core margin increased even a bit more given quarter 1, 370 basis points, reaching 42.1%. And core EPS, as you can see, $4.69, up 27%. And free cash flow, almost $10 billion.

上半年也反映出非常強勁的成長勢頭，銷售額成長 13%，核心營業收入成長 24%。第一季核心利潤率成長更大，為 370 個基點，達到 42.1%。如您所見，核心每股收益為 4.69 美元，上漲 27%。自由現金流接近 100 億美元。

Speaking of free cash flow, I think on the next slide, it's a simple slide, but I would say not less quite impressive. At 46% increase in free cash flow in the first half. And as you know, cash flow always remains a key priority for us, as our ability to convert strong operating income growth into excellent free cash flow provides, of course, plenty of capacity to reinvest, pursue bolt-on acquisitions and return capital to our shareholders through growing dividends in Swiss francs as well as share buybacks.

說到自由現金流，我想下一張投影片很簡單，但我想說它同樣令人印象深刻。上半年自由現金流成長46%。如您所知，現金流始終是我們的首要任務，因為我們能夠將強勁的營業收入成長轉化為出色的自由現金流，這當然為我們提供了充足的再投資能力、進行附加收購的能力以及通過增加瑞士法郎的股息和股票回購向股東返還資本的能力。

This brings me to the next slide, where I'm pleased to announce that we are initiating a new up to $10 billion share buyback program targeted for completion by the end of 2027. This follows the completion of our previous $15 billion share buyback program earlier this month and as part of our ongoing commitment to a balanced capital allocation. Importantly, this new buyback does not limit in any way our ability to pursue value-creating bolt-on deals and remains a key area of focus for us to continue to strengthen our pipeline and our 4 core therapeutic areas.

這讓我進入下一張投影片，我很高興地宣布，我們將啟動一項新的高達 100 億美元的股票回購計劃，目標是在 2027 年底前完成。這是繼本月初我們完成 150 億美元股票回購計畫之後的另一個舉措，也是我們持續致力於平衡資本配置的一部分。重要的是，這次新的回購不會以任何方式限制我們尋求創造價值的附加交易的能力，並且仍然是我們繼續加強我們的產品線和四個核心治療領域的重點領域。

A good example from the second quarter is the acquisition of Regulus Therapeutics, which adds an asset targeting the most common genetic cause of kidney failure worldwide in our renal pipeline. Alongside bolt-on deals, we, of course, continue to invest in our internal R&D engine. And beyond buybacks, our commitment to a strong and growing dividend in Swiss francs remain strong with a payout of CHF 7.8 billion in the first half of our annual dividend to our shareholders.

第二季度的一個很好的例子是收購 Regulus Therapeutics，這為我們的腎臟產品線增加了全球最常見的腎衰竭遺傳原因的資產。除了附加交易之外，我們當然還會繼續投資我們的內部研發引擎。除了回購之外，我們還致力於以瑞士法郎支付強勁且不斷增長的股息，上半年我們向股東派發了 78 億瑞士法郎的年度股息。

Moving now to slide 23 for the full year guidance. We continue to expect high single-digit sales growth. However, strong business momentum and good progress on ongoing productivity programs has led us to raise our bottom line guidance. We now anticipate core operating income to grow in the low teens, up from the previous low double-digit outlook.

現在轉到第 23 張投影片查看全年指示。我們繼續預期銷售額將保持高個位數成長。然而，強勁的業務勢頭和正在進行的生產力計劃的良好進展使我們提高了底線指引。我們現在預期核心營業收入將成長百分之十幾，高於先前預測的兩位數低值。

Some people asked us what is low-teens was low double-digit? Low double-digit, we see in the range of 10%, 11%, 12% and the low-teens in the 13%, 14% range. Embedded in our guidance is the assumption that Entresto US generic entry occurs mid of 2024 -- mid of 2025. However, I want to emphasize this is only for financial forecasting purposes.

有人問我們什麼是低十幾位，什麼是低兩位數？低兩位數的成長在 10%、11%、12% 的範圍內，而低十位數的成長在 13%、14% 的範圍內。我們的指導包含這樣的假設：Entresto 仿製藥將在 2024 年中期至 2025 年中期進入美國市場。然而，我想強調這只是為了財務預測目的。

Of course, we will continue to appropriately enforce our valid IP and regulatory rights that hopefully lengthen that assumption. As a reminder, US Entresto sales were $1.2 billion in quarter 2. So each month of sales is worth $400 million for us.

當然，我們將繼續適當執行我們有效的智慧財產權和監管權利，希望能延長這一假設。提醒一下，美國 Entresto 第二季的銷售額為 12 億美元。因此，我們每個月的銷售額價值 4 億美元。

To complete our full year guidance, please note that we continue to expect core net financial expenses to be around $1 billion, and our core tax rate to be around 16% to 16.5%.

為了完成我們的全年指導，請注意，我們繼續預計核心淨財務支出約為 10 億美元，核心稅率約為 16% 至 16.5%。

Now let's move to the next slide. So I want to talk you through out the phasing we expect for the remainder of the year. Usually, as you know, we don't give such detailed quarterly guidance, but in the potential transformation year with Promacta and Tasigna US generics and depending on Entresto dynamics, I hope this is helpful to describe our forecast scenario could unfold over the next couple of quarters, should Entresto generics in the US enter later in July or August.

現在讓我們來看下一張投影片。因此，我想向大家介紹一下我們預計今年剩餘時間將採取的分階段措施。通常，如您所知，我們不會提供如此詳細的季度指導，但在 Promacta 和 Tasigna 美國仿製藥的潛在轉型年，並且取決於 Entresto 的動態，我希望這有助於描述我們的預測情景，如果 Entresto 仿製藥在 7 月下旬或 8 月在美國上市，則可能在接下來的幾個季度內展開。

Clearly, if we are successful in the ongoing IP and regulatory litigation, this forecast scenario looks different without Entresto US generics. So with this forecast assumption for the second half, we anticipate mid-single-digit sales and bottom line growth to arrive at the guidance we have given for the full year after a very strong first half.

顯然，如果我們在正在進行的智慧財產權和監管訴訟中取得成功，那麼在沒有 Entresto 美國仿製藥的情況下，這種預測情景看起來會有所不同。因此，根據下半年的預測假設，我們預計在上半年表現非常強勁之後，銷售額和底線成長率將達到中等個位數，達到我們對全年的預期。

However, the dynamics in Q3 and Q4 would be quite different. We continue to expect strong growth in quarter 3 based on continued momentum in our priority brands. And of course, if there would be a generic entry, there would be initially in Q3, a bit less of an impact, even though we would expect then multiple entries on Entresto.

然而，第三季和第四季的動態將會大不相同。基於我們優先品牌的持續成長勢頭，我們繼續預計第三季將實現強勁成長。當然，如果有通用藥物進入市場，那麼在第三季度最初的影響會小一些，儘管我們預計屆時 Entresto 將會有多個進入市場的產品。

In quarter 4, however, we anticipate a step-down in growth on both top and bottom line this would reflect the full quarter impact of potential US -- ez US generics based on our financial forecasting assumption as well as a quite large prior year gross to net adjustment.

然而，在第四季度，我們預計營收和利潤的成長都會下降，這將反映出潛在的美國仿製藥對整個季度的影響——基於我們的財務預測假設以及相當大的上年毛利與淨額的調整。

You may recall when we reported quarter 4 last year, we reported 16%, but actually underlying, excluding out-of-period gross to net adjustment, was 13%. So quite a bit on top line. And then, of course, the bottom line of that is like 2.5x in terms of growth rates, right?

您可能還記得，我們去年報告第四季時報告的利潤率為 16%，但實際上，不包括期外總淨調整後的利潤率為 13%。所以頂線上有相當多的內容。當然，就成長率而言，底線是 2.5 倍，對嗎？

And therefore, if you would exclude this prior year onetime and we would have a quarter 4 and mid-single-digit sales growth in the mid- to high single-digit core operating income growth. I hope that was not too complicated. In case it was, we have, of course, the call to answer questions or our IR colleagues will take you through it later in the week.

因此，如果您一次排除去年同期的數據，我們將實現第四季度中等個位數的銷售額成長和中等至高個位數的核心營業收入成長。我希望這不會太複雜。如果是的話，我們當然會打電話來回答問題，或者我們的 IR 同事會在本週晚些時候帶您了解情況。

Now let's move to the final slide, where we outlined the expected currency impact for 2025. If mid-July rates were to prevail for the remainder of 2025, we would expect the full year currency impact to be a positive 1 percentage point on net sales and a negative 1 percentage points on core operating income. And as a reminder, we always publish these estimates on a monthly basis, assuming the exchange rates always move would hold for the rest of the year, and it's on our website, which we hope to -- that you find that helpful.

現在讓我們來看看最後一張投影片，其中我們概述了 2025 年預期的貨幣影響。如果 2025 年剩餘時間內 7 月中旬的利率保持不變，我們預期全年貨幣影響將對淨銷售額產生正 1 個百分點的影響，對核心營業收入產生負 1 個百分點的影響。提醒一下，我們總是每月發布這些估計值，假設匯率在今年剩餘時間內始終保持不變，並將其發佈在我們的網站上，我們希望 - 您覺得這有幫助。

And with that, back to Vas.

好了，回到 Vas。

Great. Thank you, Harry. So if you move to slide 27. So in summary, Novartis delivered a strong quarter 2, double-digit sales growth, core margin expansion, continuing now, I think, our tenth quarter in a row of being able to raise our guidance.

偉大的。謝謝你，哈利。因此，請移至第 27 張投影片。總而言之，諾華公司在第二季度表現強勁，銷售額實現兩位數成長，核心利潤率擴大，我認為，這是我們連續第十個季度上調業績預期。

Key launches are accelerating with consistent strong execution. You saw that particularly with Kisqali, Scemblix and Pluvicto, but broadly across the portfolio. We also continue to advance our pipeline with exciting readouts, including the Pluvicto-HSPC readout as well as now the food allergy and the YTB readouts. And we've upgraded our full year 2025 bottom line guidance.

隨著持續強勁的執行，重點產品的發布正在加速進行。這一點尤其體現在 Kisqali、Scemblix 和 Pluvicto 上，但在整個投資組合中都普遍存在。我們還將繼續透過令人興奮的讀數來推進我們的管道，包括 Pluvicto-HSPC 讀數以及現在的食物過敏和 YTB 讀數。我們也上調了 2025 年全年獲利預期。

But importantly, with our current outlook, we remain highly confident in our mid- to long-term growth outlook, and this gives us the confidence as well to take on another $10 billion share buyback.

但重要的是，根據我們目前的前景，我們對中長期成長前景仍然充滿信心，這也使我們有信心再進行 100 億美元的股票回購。

Now moving to slide 28. I did want to say a word about the announcement we made earlier today. As part of an orderly transition, which we're always committed to, first, I want to thank Harry for his unwavering commitment and over -- with over 22 years at Novartis.

現在翻到第 28 張投影片。我確實想就我們今天早些時候宣布的事情說幾句話。作為我們始終致力於的有序過渡的一部分，首先，我要感謝哈里在諾華 22 年多來的堅定承諾。

At the end of this year, Harry will have completed 13 years as CFO. And I think truly one of the great leaders in the history of our company, being able to reshape Novartis into the pure-play medicines company we are today, so very grateful and very indebted to Harry for all of his amazing contributions. He will retire and step down from the ECN effective March 15, 2026.

到今年年底，Harry 擔任財務長將滿 13 年。我認為他確實是我們公司歷史上最偉大的領導者之一，能夠將諾華重塑為如今的純粹醫藥公司，因此非常感謝 Harry 所做的所有傑出貢獻。他將於 2026 年 3 月 15 日起退休並辭去 ECN 職務。

And a warm welcome to Mukul Mehta, who will join us as our new CFO. I enjoyed the ECN effective March 16, 2026. Mukul joined Novartis in 2003. He has done all of the key financial roles across the company. And after a rigorous selection process was clearly the best leader, we believe, to lead Novartis into this next chapter.

熱烈歡迎穆庫爾梅塔 (Mukul Mehta) 加入我們，擔任新任財務長。我很享受 2026 年 3 月 16 日生效的 ECN。穆庫爾於 2003 年加入諾華。他曾擔任過公司所有關鍵的財務職位。經過嚴格的選拔程序，我們相信，他無疑是帶領諾華邁入新篇章的最佳領導者。

So a big warm welcome as well to Mukul. So with that, I think we can open the line to questions.

我也熱烈歡迎 Mukul。因此，我想我們可以開始提問了。

(Operator Instructions)

（操作員指示）

Sachin Jain from Bank of America

美國銀行的 Sachin Jain

Hi there. Thanks for taking my questions. First one, just on Sjogren's actually, if I may. Vas, thanks for confirming may you could just update on your level of confidence into the Phase II data 3Q? And can you just clarify whether you need both studies to be positive for a filing process?

你好呀。感謝您回答我的問題。首先，如果可以的話，我實際上只討論乾燥症。Vas，感謝您的確認，能否更新一下您對第二階段第三季數據的信心程度？您能否澄清一下，是否需要兩項研究都對申請流程產生正面影響？

Thank you

謝謝

Yes. Thanks, Sachin. So on Sjogren's, look, I think this is an incredibly exciting opportunity, but I think we should acknowledge that there's been no drug that's ever been demonstrating a benefit on -- to just to be a significant benefit on the SIs. So I think we go in with a very strong Phase II data, we believe very much in the mechanism, but also acknowledging this is a tough indication, and so it definitely has risk going into the Phase III.

是的。謝謝，薩欽。因此，就乾燥症而言，我認為這是一個非常令人興奮的機會，但我認為我們應該承認，還沒有任何藥物被證明對乾燥症有益——僅僅是對乾燥症有顯著的益處。因此，我認為我們進入第二階段時擁有非常強勁的數據，我們非常相信該機制，但也承認這是一個艱難的跡象，因此進入第三階段肯定存在風險。

Now in terms of whether or not both studies, I think that really depends on the data. We've had very robust discussions with FDA both on the primary endpoint and secondary endpoints where we have full agreement. So I think based on the data on the two studies, we'll -- and of course, given the one study has third dose level or dosing that's every three months versus every month, I think we'll have the opportunity to look at different statistical approaches and then find the best path forward.

現在就這兩項研究是否有效而言，我認為這確實取決於數據。我們與 FDA 就主要終點和次要終點進行了非常深入的討論，並達成了完全一致的意見。因此，我認為，基於這兩項研究的數據，我們——當然，考慮到一項研究有第三種劑量水平或劑量，即每三個月而不是每個月一次，我認為我們將有機會研究不同的統計方法，然後找到最佳的前進道路。

So we're looking forward to getting to the database locks and then ultimately, the readout. And then given that these studies are very close together, we would plan on informing the markets based on the results of both studies at the same time.

因此，我們期待獲得資料庫鎖，然後最終獲得讀數。鑑於這些研究非常接近，我們計劃同時根據兩項研究的結果向市場通報。

Shirley Chen from Barclays,

巴克萊銀行的 Shirley Chen，

Hi, thank you for taking my question. So one on Cosentyx. So you called out a slowdown in Cosentyx uptake in China due to broader-based health care spending tightening. So can you please share more about how significant this impact is relative to your assumptions?

你好，謝謝你回答我的問題。因此，Cosentyx 是一個不錯的選擇。因此，您指出，由於整體醫療支出緊縮，Cosentyx 在中國的吸收量有所放緩。那麼，您能否進一步說明一下，相對於您的假設，這種影響有多大？

And whether it is affecting broader portfolio? And how are you adapting your China strategy to maintain growth in the face of increasing constrained government pricing? And also something interesting that you mentioned on like growth from out-of-pocket in China. Do you think it will be the case for your other products for the commercialization in China?

它是否會影響更廣泛的投資組合？在政府定價受到越來越多的限制的情況下，您如何調整中國策略以保持成長？您也提到了一些有趣的事情，例如中國自付費用的成長。您認為您的其他產品在中國的商業化也會如此嗎？

Thank you so much.

太感謝了。

Yes. Thank you, Shirley. So for China broadly, we have seen, over the first 6 months of this year, a notable slowdown. Our China business last year was growing over 20%, and we saw very robust overall market growth as well. This year, we have seen a broad, at least on to the data we're seeing, sector-wide slowdown in ph

是的。謝謝你，雪莉。因此，就中國整體而言，我們看到今年前六個月的經濟明顯放緩。去年我們在中國的業務成長了20%以上，也看到了非常強勁的整體市場成長。今年，我們看到了廣泛的，至少從我們看到的數據來看，整個行業的 PH 成長放緩

And then now off of this base, we'll continue to, as I noted, to see our business grow in that high single digit to low teens-plus range.

然後，現在以此為基礎，正如我所指出的，我們將繼續看到我們的業務在高個位數到低十位數以上的範圍內成長。

Now in terms of -- and this is fully factored into our midterm guidance, long-term guidance, so no shifts in guidance because of this with respect to China. Now in terms of Leqvio out of pocket, it hasn't been, I think, a pleasant surprise to see how stro armaceutical spending.

就這一點而言——這已完全計入我們的中期指導和長期指導中，因此與中國相關的指導不會因此而改變。就Leqvio的自付費用而言，我認為看到其在醫藥方面的支出如此強勁，並不令人驚訝。

. And we see our growth coming down as well. Now we continue to expect to see China grow for Novartis in the high single digit to low-teens range. So still very robust growth. But we do see this though as, I think, a reset in the market because a number of the policies that have been put in place to limit prescription spending, I think, will continue on for the years to come.

。而且我們發現我們的成長率也在下降。現在，我們繼續預期諾華在中國的業績將維持高個位數至低十位數的成長。因此成長仍然非常強勁。但我認為，我們確實將此視為市場重置，因為我認為，為限制處方藥支出而實施的許多政策將在未來幾年繼續實施。

So we continue to see China as a double-digit growth market for Novartis but maybe not at the 20%-plus range where we've been historically. So this is impacting the portfolio broadly, primarily medicines that are part of the NRDL listing.

因此，我們繼續認為中國是諾華的兩位數成長市場，但可能不會達到我們歷史上的 20% 以上的水平。因此，這對藥品組合產生了廣泛影響，主要是國家醫保目錄內的藥品。

As you noted, not medicines that are private market and particularly medicines that are higher volume medicines. We saw the impact primarily Cosentyx, Entresto, drugs like Lucentis, these are the medicines where we saw the largest impact through the first 6 months of the year. We expect this to stabilize in the second half. ng that uptake has been. And I think it does give us confidence that in the future when we launch a medicines of a similar profile we can go out of pocket and then make a decision whether it makes sense to move into the NRDL listing at a lower price versus continuing in the out of pocket.

正如您所說，這不是私人市場的藥品，尤其是銷售量較大的藥品。我們主要看到 Cosentyx、Entresto 和 Lucentis 等藥物受到影響，這些是我們在今年前 6 個月看到的影響最大的藥物。我們預計這一情況將在下半年穩定下來。我認為這確實給了我們信心，將來當我們推出類似藥品時，我們可以自掏腰包，然後決定以較低的價格進入國家醫保目錄還是繼續自掏腰包。

I think that's an ongoing debate for us right now as to when we'll move Leqvio into the NRDL listing. But I think seeing that out-of-pocket market materialize in China, I think, is also positive overall for the sector.

我認為我們現在正在爭論何時將 Leqvio 納入國家醫療保健目錄。但我認為，看到自付費用市場在中國實現，對於該行業來說總體上也是有利的。

Peter Verdult from BNP Paribas

法國巴黎銀行的 Peter Verdult

Yes. Peter Verdult, BNP Paribas. Vas, I'm probably the millionth person to ask you, I'm sure you're tied having to respond, but the sector is under a cloud, investor apathy is high, concerns more on pricing than tariffs. But is there anything you can share with us in terms of latest you've heard from CMS, HHS, your people on the hill, about what the administration is thinking about in terms of framework implementation or when we might hear what they plan to do going forward on drug pricing in the US?

是的。法國巴黎銀行的 Peter Verdult。Vas，我可能是第 100 萬個問你的人，我相信你一定不得不回答，但該行業正處於陰雲之下，投資者的冷漠程度很高，人們更關心的是定價而不是關稅。但是，您能否與我們分享您從 CMS、HHS 和國會山人士那裡聽到的最新消息，關於政府在框架實施方面的想法，或者我們何時可以聽到他們計劃如何推進美國藥品定價？

Thank you

謝謝

Yes. Thanks, Peter, and not at all, happy to have these -- have that discussion because it keeps evolving on an ongoing basis. I would say, broadly speaking, that the conversations with the administration from the Novartis standpoint have been productive, very open dialogue, trying to find solutions. And the goal is very much to see how can we have the markets outside of the US in the OECD, pay more for innovative medicines, which we fully support to really reward innovation and pay help support the R&D efforts of the industry as well as give patients in the US

是的。謝謝，彼得，我非常高興進行這些討論，因為它正在不斷發展。我想說，總體而言，從諾華的角度來看，與管理層的對話是富有成效的，非常開放的對話，試圖找到解決方案。我們的目標是看看如何讓美國以外的市場進入經合組織，為創新藥物支付更多費用，我們全力支持創新，真正獎勵創新，並支付費用，幫助支持該行業的研發工作，並為美國患者提供

options for lower-priced medicines, in our view, primarily through going more direct and cutting out much of the 50% to 60% that goes to PBMs, 340B, all of the other elements in the system.

我們認為，低價藥品的選擇主要是透過更直接的方式，並削減流向 PBM、340B 和系統中所有其他元素的 50% 到 60% 的費用。

And so that's where we're trying to find the solution space. We're moving forward with proposals. HHS is also evaluating our proposals, and we're looking at the different options. So I think it will still be some time before we get to full resolution. But I'd say there's a strong desire within the administration to maintain US

這就是我們試圖尋找解決方案空間的地方。我們正在推進提案。衛生與公眾服務部也在評估我們的提案，我們正在研究不同的選擇。所以我認為我們還需要一段時間才能完全解決問題。但我想說，政府內部有強烈的願望來維持美國

leadership in biopharmaceutical innovation and not seed that leadership to China or any other market.

生物製藥創新領域的領導地位，而不是將這種領導地位轉移到中國或任何其他市場。

So I think that's very much high in their minds to ensure they get the balance right. And I think that's what we're continuing to work towards. I think we also have to do a better job educating more broadly about the fact that in the US, while there is a disparity in innovative medicine spend, overall, given that 94% of volume in the US is estimated to be generic medicines and the US has the lowest generic prices amongst the major OECD countries in the world that actually the US

所以我認為他們非常重視確保正確的平衡。我認為這就是我們繼續努力的目標。我認為，我們還必須更好地開展更廣泛的教育，讓大家了解這樣一個事實：在美國，雖然在創新藥物支出方面存在差距，但總體而言，考慮到美國 94% 的藥物是仿製藥，而且美國是世界上主要 OECD 國家中仿製藥價格最低的國家，實際上美國

total drug bill, when it's appropriately volume adjusted, is actually lower than many other countries overseas, most of the countries in OECD.

經過適當數量調整後，藥品總費用實際上低於許多其他海外國家，包括大多數經合組織國家。

So we just have to keep educating about these dynamics that the US system works extremely well. It rewards innovation during the patent period, but then it's extremely effective at genericizing medicines as well. And I think that's something we need to do a better job of in educating policymakers. So yes, thank you very much for the question.

因此，我們必須不斷宣傳這些動態，以證明美國體系運作得非常好。它獎勵專利期內的創新，但它在藥品仿製藥方面也非常有效。我認為我們需要在教育政策制定者方面做得更好。是的，非常感謝您的提問。

Simon Baker from Rothschild and Company Redburn.

羅斯柴爾德雷德伯恩公司的西蒙貝克。

Thanks for taking my question. One on Cosentyx, please. I'm just wondering if you could flesh out a few elements from the slide. Firstly, can you give us any more color on the price/volume dynamic so far this year? And also, why -- if you could elaborate a bit more on the -- your comments on the competitive environment and why you see that as a temporary factor rather than an ongoing headwind? Thanks so much.

感謝您回答我的問題。請給我一份關於 Cosentyx 的資料。我只是想知道您是否可以充實幻燈片中的幾個元素。首先，您能否向我們詳細介紹今年迄今的價格/銷售動態？此外，為什麼——如果您可以更詳細地闡述——您對競爭環境的評論，以及為什麼您認為這是一個暫時的因素，而不是持續的逆風？非常感謝。

Yeah. So I'll give the price, volume dynamics to Harry. Harry?

是的。因此，我會將價格和成交量動態告知 Harry。哈利？

Yes. Overall, of course, in Cosentyx, we do have an impact as we laid out due to the Medicare Part D redesign. So rebates go up as we contribute in the catastrophic phase, whereas the prior design where we didn't do that. The two brands where you see is mainly in our portfolio is Cosentyx and Kisqali. Obviously, Kisqali launched completely kind of over overweight that.

是的。總體而言，正如我們所指出的，Cosentyx 確實受到了 Medicare Part D 重新設計的影響。因此，當我們在災難階段做出貢獻時，回扣就會增加，而在先前的設計中我們並沒有這樣做。您在我們的產品組合中主要看到的兩個品牌是 Cosentyx 和 Kisqali。顯然，Kisqali 的推出完全有點過度了。

But Cosentyx, that it has some impact also. Of course, there's also then the effect that last year, the HS launch really got momentum as of Q2, so the comparable base is quite high.

但 Cosentyx 也有一定的影響。當然，還有一個影響是，去年 HS 的推出從第二季開始才真正獲得了動力，因此可比基數相當高。

Thanks, Harry. And then in terms of the competitive entry, I think, Simon, the way we see it is often -- and we've experienced this many times over the last decade with Cosentyx. As when a new competitor enters, there is an initial impact and then the market settles down a new dynamic.

謝謝，哈利。然後就競爭進入而言，西蒙，我認為我們經常看到這種情況——而且在過去十年中，我們在 Cosentyx 上經歷過很多次這種情況。當新的競爭對手進入時，會產生最初的影響，然後市場就會穩定下來，形成新的動態。

I mean when you look at Cosentyx is very strong frontline access across all of the relevant indications, including HS. The opportunity we see is that while initially now during the launch of the competitor that patients who were not achieving full control on Cosentyx monthly, let's say, after 9 months or 1 year, were switching off to the competitor product.

我的意思是，當您看到 Cosentyx 在所有相關適應症（包括 HS）中都具有非常強大的一線治療能力。我們看到的機會是，雖然最初在競爭對手推出期間，那些每月無法完全控制 Cosentyx 的患者，比如說，在 9 個月或 1 年後，就會轉而使用競爭對手的產品。

I mean we see the opportunity to educate more to -- there's the option to move to a bimonthly increase, in effect, increased dosing of Cosentyx to achieve disease control. I think as we do that, we'll be able to moderate some of the switches off of Cosentyx.

我的意思是，我們看到了進行更多教育的機會——可以選擇每兩個月增加一次 Cosentyx 的劑量，實際上增加劑量以控制疾病。我認為，當我們這樣做時，我們將能夠緩和 Cosentyx 的一些關閉。

And then second, we continue to see the opportunity where we have very strong performance in that first switch off of the anti-TNFs. And there as well, I think we're going to continue to work to do better. And that will become, I think, a solid source of growth for Cosentyx and HS.

其次，我們繼續看到機會，在首次關閉抗 TNF 時，我們表現非常強勁。我認為我們將繼續努力做得更好。我認為這將成為 Cosentyx 和 HS 的堅實成長來源。

Taken together, we continue to see HS as a $3 billion-plus market in Cosentyx as a brand that can deliver $1 billion of sales in HS, which gives us confidence overall in our $8 billion guidance -- peak sales guidance.

綜合起來，我們繼續認為 HS 是一個價值 30 多億美元的市場，而 Cosentyx 作為一個品牌，可以在 HS 中實現 10 億美元的銷售額，這讓我們對 80 億美元的指導（峰值銷售指導）充滿信心。

Great. Thanks so much.

偉大的。非常感謝。

Next question?

下一個問題？

Richard Vosser from JPMorgan

摩根大通的 Richard Vosser

Hi, thanks for taking my question. Just one more on Cosentyx. Just as we look out with that, I think, mid-single-digit growth that you implied to '29. How should we think about direct negotiation towards the end of that period? Do you think Cosentyx will get hit by that in terms of the IRA or should we not be expecting that?

你好，謝謝你回答我的問題。關於 Cosentyx 還有一個。正如我們所期待的，我認為，到 29 年，我們將會實現中等個位數的成長。在這段時期即將結束時，我們該如何看待直接談判？您認為 Cosentyx 會受到 IRA 的打擊嗎？或者我們不應該期待這一點？

Thank you very much.

非常感謝。

Yes. Thanks, Richard. We factored IRA into all of our guidance. So that would be the first point. I think Cosentyx overall, we estimate to be -- about 30% of our sales are exposed to Medicare pricing.

是的。謝謝，理查。我們將 IRA 納入了我們所有的指導之中。這就是第一點。我認為，總體而言，我們估計 Cosentyx 的銷售額中約有 30% 受到醫療保險定價的影響。

So certainly, there will be an impact. But overall, we think it can be managed appropriately, and that is factored in as well into the guidance we have.

所以一定會有影響。但總體而言，我們認為可以對其進行適當的管理，並且這也已考慮到我們的指導中。

I think overall, so with IRA, I think it was a net positive that the Orphan Cures Act was enacted as part of the recent reconciliation package which enables medicines to have multiple rare diseases as part of -- without having to give up the medicines exclusion from the IRA negotiation price setting. So I think that's a positive overall as well for the sector. But all factored in and at 30%, we think manageable.

我認為總體而言，對於 IRA 來說，我認為《孤兒藥法案》作為最近的和解方案的一部分頒布，具有積極的意義，該方案允許藥品治療多種罕見疾病 - 而不必放棄將藥品排除在 IRA 談判價格製定之外。所以我認為這對該行業來說總體上也是一件好事。但考慮到所有因素，我們認為 30% 是可以控制的。

Excellent, thanks.

非常好，謝謝。

Next question.

下一個問題。

Michael Leuchten from Jefferies

來自 Jefferies 的 Michael Leuchten

Oh, thank you very much, put on. Hold please. It looks like the.

噢，非常感謝，戴上。請稍等。看上去就像。

Apologies, Michael, we cannot really hear you. Your audio is really bad.

抱歉，邁克爾，我們聽不到您的聲音。你的音頻品質真的很差。

Okay. I shall try again. A question on It looks like the IgAN as well to C3G performance is quite well. You've got coming, but the way you frame the product and the opportunity still seems a little bit conservative, so I was just wondering what are you looking for to maybe become a bit more optimistic about the performance of the overall franchise?

好的。我會再試一次。一個問題看起來 IgAN 和 C3G 的表現都相當好。您已經開始了，但是您建立產品和機會的方式似乎仍然有點保守，所以我只是想知道您在尋找什麼，以便對整個特許經營的表現更加樂觀一些？

Yes. I think overall with Fabhalta, we believe each 1 of these indications can stack up to be $1 billion, $1 billion and get us over to our peak sales guidance for this medicine overall. So I think there's clearly the opportunity in IgAN, where we've positioned the medicine with the higher pricing that we've set, just to get physicians more and more comfortable with using it in that later-line setting. . C3G as well, good opportunity.

是的。我認為總體而言，我們相信 Fabhalta 的每一種適應症都可以累積到 10 億美元，並使我們達到該藥物整體的最高銷售預期。因此，我認為 IgAN 領域顯然存在機會，我們將藥物定位於更高的價格，只是為了讓醫生越來越願意在後期環境中使用它。. C3G 也一樣，好機會。

PNH, we're seeing continued uptake as well. So I think we're very optimistic overall so the intention was not show a lot of optimism. More I think that this will be a steady climb. I don't think we're going to see a rapid inflection that's going to take time as we build out IgAN, as we build out in C3G. In PNH, as we work through the various vaccination requirements, I mean every one of these things will have to be worked through and then step by step as we add more and more indications, we think we'll get to that significant peak sales that we've guided to.

PNH，我們也看到了持續的成長。所以我認為我們總體上非常樂觀，所以我們的意圖並不是表現出太多的樂觀。我更加相信這將是一次穩步的攀登。我認為，隨著我們建造 IgAN 和 C3G，我們不會看到需要時間的快速轉變。在 PNH 中，當我們處理各種疫苗接種要求時，我的意思是每一件事都必須解決，然後隨著我們逐步增加越來越多的適應症，我們認為我們將達到我們預期的顯著銷售高峰。

Emmanuel Papadakis from Deutsche Bank

德意志銀行的伊曼紐·帕帕達基斯

Perhaps I'll take a question on remibrutinib, if I may. Intriguing to hear about the positive Phase II in food in allergy. Perhaps you could just give us an indication of how that compares to the OLED agent setting and perhaps your willingness to go head-to-head in Phase III to round out the profile? And then maybe just a reminder on your expectations, the speed of commercial CSU launch assuming approval later this year, that also would be helpful?

如果可以的話，我或許會回答一個關於瑞布替尼的問題。聽到食物過敏第二階段的正面進展很有趣。也許您可以向我們說明一下這與 OLED 代理設定相比如何，以及您是否願意在第三階段進行正面交鋒以完善概況？然後也許只是提醒一下您的期望，假設今年稍後獲得批准，商業 CSU 的推出速度也會有所幫助嗎？

Thank you.

謝謝。

Yes. Thanks, Emmanuel. On food allergy, obviously, we'll present the data at an upcoming Medical Congress. But we see the results as very compelling relative to Xolair, particularly for an oral option in this setting. Xolair is an effective -- has been effective and successful in food allergy, but I think having an oral therapy, very strong safety, clean safety profile, and when we looked at the comparable cross-trial comparisons, we saw, I think, a pretty compelling overall profile.

是的。謝謝，伊曼紐。關於食物過敏，顯然，我們將在即將召開的醫學會議上公佈數據。但我們認為與 Xolair 相比，其結果非常引人注目，尤其是對於這種情況下口服的選擇。Xolair 是一種有效的藥物，在食物過敏方面一直有效且成功，但我認為它是一種口服療法，安全性非常高，安全性清晰，當我們查看可比較的交叉試驗比較時，我們看到了相當引人注目的整體概況。

So we feel pretty good about that. I think the opportunity will clearly depend on how broad an indication we can ultimately get. And then over time as well moving into the adolescent more pediatric range with remibrutinib. But yes, I think, overall, favorably positioned.

所以我們對此感覺很好。我認為機會顯然取決於我們最終能獲得多廣泛的指示。隨著時間的推移，瑞布替尼也逐漸進入青少年和兒科治療範圍。但我認為，總體而言，我們處於有利地位。

In terms of head-to-head studies, all under evaluation. I mean we got these results just a few weeks ago. So I think we're currently evaluating what is the optimal Phase III, but also Phase IIIb any additional studies we'll need to do to ensure remibrutinib is appropriately positioned versus biologics.

就頭對頭研究而言，一切都在評估之中。我的意思是我們幾週前才得到這些結果。因此我認為我們目前正在評估最佳的 III 期，以及 IIIb 期我們需要做的任何額外研究，以確保 remibrutinib 與生物製劑相比具有適當的定位。

Now in terms of CSU, we're quite excited. We think there's a significant opportunity here. When you look at remibrutinibs profile having a drug that is able to work after 2 weeks and then have this consistent ability over 52 weeks to manage the symptoms of urticaria I think is very compelling. And so we expect both in the US and ex US, is there to be a strong patient and physician demand.

現在就 CSU 而言，我們非常興奮。我們認為這裡有一個重大機會。當您查看瑞布替尼的概況時，您會發現該藥物能夠在 2 週後起效，並且在 52 週內具有持續控制蕁麻疹症狀的能力，我認為這非常引人注目。因此，我們預計，無論是在美國還是美國以外，患者和醫生的需求都會很強勁。

So we'll see how the first months go, but I think it could be hopefully an attractive uptake in the early months. I'd also note, I mean, we're doing a head-to-head versus dupilumab to really show that in the early period where patients want resolution that we can demonstrate a stronger profile than a biologic. That will also, I think, it would be important data that we'll get out there as well.

因此，我們將觀察頭幾個月的情況，但我認為希望在最初幾個月內會出現有吸引力的成長。我還要指出的是，我們正在與 dupilumab 進行正面交鋒的對比研究，以真正表明在患者希望得到解決的早期階段，我們可以展示出比生物製劑更強的效果。我認為，這也將是我們將獲得的重要數據。

So we're investing heavily to make remibrutinib as significant as possible, CSU, food allergy, we have the HS study ongoing, we have the 2 MS studies ongoing. So we'll try to maximize this medicine over the coming years.

因此，我們正在大力投資，使 remibrutinib 盡可能發揮重要作用，CSU、食物過敏、HS 研究正在進行中，我們也正在進行 2 項 MS 研究。因此，我們將在未來幾年內盡力發揮這種藥物的功效。

Thank you.

謝謝。

Next question.

下一個問題。

Harry Sephton from UBS

瑞銀集團的 Harry Sephton

Just wanted to follow up on MSN. So how does the industry go about getting ex US countries to pay significantly more? And presumably, this wouldn't be on current products, but only new product launches. So in this case, with the consequences of this be fewer and new product launches in markets that don't accept your price?

只是想跟進 MSN。那麼，該產業如何讓美國以外的國家支付更多費用呢？據推測，這不會針對現有產品，而只會針對新產品的發布。那麼在這種情況下，其後果是，在不接受您的價格的市場上推出的新產品會減少嗎？

Thank you.

謝謝。

Yes, I think it's all good questions, and I don't think there's a single easy answer. What I would say is in the medium to long term, there's a few things that the industry is strongly advocating for, particularly with respect to trade negotiations. I think with the trade negotiations, we feel strongly that when you look at the percent of spend on innovative medicines relative to GDP, you see that the US is significantly higher than most of these OECD markets.

是的，我認為這都是很好的問題，而且我認為沒有一個簡單的答案。我想說的是，從中長期來看，業界強烈倡導一些事情，特別是在貿易談判方面。我認為，透過貿易談判，我們強烈感覺到，當你查看創新藥物支出佔 GDP 的百分比時，你會發現美國的比例明顯高於大多數經合組織市場。

So one, can we get a commitment from these key markets to increase their funding for innovative medicines as part of their overall government budget? And if we can get that into trade negotiations, that would at least set the bench that the actual pool of money available up.

那麼，我們能否獲得這些主要市場的承諾，將增加對創新藥物的資助作為其整體政府預算的一部分？如果我們能夠將其納入貿易談判中，那麼至少可以為實際可用的資金池奠定基礎。

Then I think separate from that, there's a few specific policy changes that we continue to advocate for as part of the trade negotiation, but also independent of the trade negotiations. One is to end the practice of clawbacks for above sector growth or above benchmark growth, many European countries.

然後我認為除此之外，我們將繼續倡導一些具體的政策變化，作為貿易談判的一部分，但也獨立於貿易談判。一是終止許多歐洲國家對高於產業成長或高於基準成長的追回做法。

When the sector grows faster than an artificially set growth cap, the growth has to get reimbursed back, the practice that when you have new indications, which you've invested for that benefit more patients, that you face a price cut rather than at least price maintenance, much less a price increase because you've demonstrated more patients can benefit. So that I think there's clear policy solutions as well.

當該行業的成長速度超過人為設定的成長上限時，成長速度必須得到補償，這種做法是，當你有新的適應症時，你為使更多患者受益而投資，你面臨的是降價，而不是至少維持價格，更不用說漲價了，因為你已經證明更多的患者可以受益。所以我認為也有明確的政策解決方案。

Now I think, clearly, if -- depending on how the MFN policy, if it does get rolled out or how it gets rolled out, there will be situations where we would have to leave medicines, to us, but also other company -- every other company in the sector in the private market and not go into government reimbursement. I would say that's likely where you'll see a shift in thinking.

現在我認為，很明顯，如果——取決於最惠國政策如何實施，或者如何實施，就會出現這樣的情況：我們不僅要把藥品留給我們自己，還要留給其他公司——私人市場上該行業的所有其他公司，而不去獲得政府報銷。我想說，你很可能會看到思維的轉變。

If there are markets that require you to go into the public market, then of course, you'd have to consider not launching in those markets. But I think all of this is TBD, and it all depends on the details of how the policies are created and set.

如果有些市場要求你進入公開市場，那你當然必須考慮不進入這些市場。但我認為這一切都還有待確定，一切都取決於政策的製定和設定細節。

James Quigley from Goldman Sachs

高盛的詹姆斯奎格利

Great, thank you for answering my questions. Firstly, congrats Harry on the retirement and all the best for the future. I've got a question on Pavecto. So obviously, you've highlighted some encouraging metrics following the PSMA 4 launch. How are you thinking about using earlier lines, I know you have PSMA addition? Patients tend to be typically a bit younger here and a few KOLs you've spoken to have suggested that they may think twice about radioligand therapy due to potential impacts on continence and sexual function.

太好了，謝謝你回答我的問題。首先，恭喜哈利退休並祝他未來一切順利。我有一個關於 Pavecto 的問題。顯然，您強調了 PSMA 4 發布後的一些令人鼓舞的指標。您如何考慮使用早期的線路，我知道您有 PSMA 附加功能？這裡的患者通常比較年輕，您採訪過的一些關鍵意見領袖表示，他們可能會三思而後行放射性配體療法，因為這可能會對禁慾和性功能產生影響。

Is this consistent with what you may be hearing or could this be more of a minority view? And are there any differences in sort of geographic launch you're expecting in the earlier lines, so maybe less worries in the US versus ex US? And related to that, how does the -- how could the Actinium PSMA fit into which we should just move into Phase II, how could that fit into the market as you positioned towards early lines as well?

這與您所聽到的一致嗎？或者這只是少數人的觀點？您預期早期產品線在地理發布方面是否存在差異，因此與美國以外地區相比，美國市場的擔憂可能會更少一些？與此相關的是，Actinium PSMA 如何適應我們應該進入第二階段的情況，它如何適應市場，因為您也定位在早期產品線？

Thank you.

謝謝。

Yes. Thanks, James. When -- so we haven't heard that feedback. Pluvicto safety profile is quite compelling. I think with respect to the sexual function and chemical castration, I mean that really is a consequence of some of the other hormonal therapies that these patients are on.

是的。謝謝，詹姆斯。什麼時候——所以我們還沒聽到回饋。Pluvicto 的安全性相當引人注目。我認為就性功能和化學閹割而言，這實際上是這些患者正在接受的其他一些荷爾蒙療法的結果。

So I think the question could become, could we get to a point where we get early enough where you don't have that impact on patients.

所以我認為問題可能是，我們能否儘早達到不會對病人產生影響的程度。

But Pluvicto itelf primary topics are generally speaking, salivary glands and bone marrow and so some of the hematologic side effects. And so I think we feel pretty confident overall. In fact, what we usually hear is that people are struck by how well tolerated Pluvicto is in various patient populations.

但Pluvicto本身的主要主題一般來說是唾液腺和骨髓等一些血液學副作用。所以我認為我們總體上非常有信心。事實上，我們通常聽到的是，人們對 Pluvicto 在不同患者群體中的耐受性感到震驚。

And I do think, as we move earlier lines, there is more competition. So there will be, I think, different ways that Pluvicto might end up being used. But we expected with the compelling RPFS data and as the OS data hopefully matures in the right direction, we have a very compelling case for a significant use in HSPC, where it's used on top of standard of care.

我確實認為，隨著我們推進早期路線，競爭將會更加激烈。因此，我認為 Pluvicto 最終可能會有不同的用途。但是我們預計，憑藉令人信服的 RPFS 數據，並且隨著 OS 數據朝著正確的方向成熟，我們將有一個非常令人信服的案例證明它在 HSPC 中具有重要用途，在標準護理之上使用。

And then, of course, in the pre-chemo and post-chemo settings in CRPC. So I think overall, I think we feel pretty confident that Pluvicto will continue on the peak sales guidance that we've laid out. Now ex US, I think the topic in ex US is a little bit different.

當然，還有 CRPC 的化療前和化療後設定。因此我認為總體而言，我們非常有信心 Pluvicto 將繼續保持我們所製定的銷售高峰預期。現在除了美國，我認為美國以外的話題有點不同。

You quite asked ex US Ex US really comes down to the comparator choice. We've designed these studies very much with the US in mind depending on the geography or country in question, there is sometimes a request for different comparators and then we have to decide is it worth doing those additional studies or not.

您確實問過美國以外的問題，而美國以外的問題實際上取決於比較器的選擇。我們在設計這些研究時，很大程度上考慮了美國的情況，這取決於所涉及的地理位置或國家，有時會要求使用不同的比較器，然後我們必須決定是否值得進行這些額外的研究。

Certainly, in the vision population, we've already launched in multiple European markets and preparing to launch in Asia. We think with the PSMAddition trial design, we have a very compelling case to have that launched. Probably the one where there's a little bit more geographic variability is the PSMAfore study.

當然，在願景人群中，我們已經在多個歐洲市場推出了產品，並準備在亞洲推出。我們認為，有了 PSMAddition 試驗設計，我們就有非常有說服力的理由推出試驗。可能存在更多地理差異的研究是 PSMAfore 研究。

Now in terms of the actinium, the current plan is to move that in the post Pluvicto setting, so for patients who are progressing on Pluvicto then switch from a lutetium to an alpha-emitter actinium to see if we can obtain control or achieve control of the cancer.

現在就錒而言，目前的計劃是在 Pluvicto 治療後進行轉移，因此對於在 Pluvicto 治療中病情進展的患者，將從鎔轉換為 α 發射體錒，看看我們是否可以獲得控製或實現對癌症的控制。

And then there is the question as well, if safety profile is compelling, would we go even earlier with the actinium-based PSMA? I mean I think that is still an open question as to -- with lutetium, given the long history we have now both with Lutathera and Pluvicto, that we have a very compelling safety profile and safety understanding.

那麼還有一個問題，如果安全性令人信服，我們是否會更早採用基於錒的 PSMA？我的意思是，我認為這仍然是一個懸而未決的問題——對於镥，鑑於我們與 Lutathera 和 Pluvicto 的悠久歷史，我們擁有非常令人信服的安全性概況和安全理解。

I think with actinium, still lots to learn, figuring out what is the dose interval, what is the appropriate dose in different patient populations? It is, as an alpha emitter can be stronger on certain tissues. So those are all things we're working through.

我認為對於錒，仍有許多東西需要學習，弄清楚劑量間隔是多少，不同患者群體的適當劑量是多少？是的，因為 α 射線發射體對某些組織的作用更強。這些都是我們正在努力解決的事情。

But we have multiple PSMA actiniums in-house, and we're working through what's the right approach. But the Phase III you see right now is in post-Pluvicto patients in the CRPC and I could see if we move it earlier in subsequent trials.

但我們內部擁有多個 PSMA 錒系元素，我們正在研究正確的方法。但是您現在看到的 III 期試驗是在 Pluvicto 治療後的 CRPC 患者中進行的，我可以看看我們是否可以在後續試驗中提前。

Next question operator.

下一個問題操作員。

Kerry Holford from Berenberg.

來自貝倫貝格的 Kerry Holford。

Oh thank you for taking my question. On capital allocation, the new share buyback program, $10 billion, it's clearly smaller than the size of your previous program and to be spent over a similar time frame. So just interested to understand why you're more conservative here? Going forward, does this signal a growing appetite perhaps for development over that time frame or any other expected demands that would change on your future cash flow?

哦，謝謝你回答我的問題。在資本配置方面，新的股票回購計劃為 100 億美元，這顯然比您之前的計劃規模要小，而且將在類似的時間範圍內使用。所以只是想了解為什麼你在這裡更保守？展望未來，這是否預示著在這段時間內對開發的需求會不斷增長，或者任何其他預期的需求會改變您未來的現金流？

Thank you.

謝謝。

Thanks, Carry. Harry.

謝謝，Carry。哈利。

Yes. Thank you, Kerry. So first of all, we are absolutely convinced of our five-year plan, 5% sales CAGR, right? And with that, continued core operating income and free cash flow growth. So clearly, strong cash flow last year, $16 billion; this year, $10 million in the first half, so continued very good cash flow growth.

是的。謝謝你，克里。首先，我們對我們的五年計劃，5%的銷售額複合年增長率，絕對有信心，對嗎？同時，核心營業收入和自由現金流持續成長。顯然，去年的現金流強勁，達到 160 億美元；今年上半年現金流達到 1,000 萬美元，因此現金流持續保持良好的成長動能。

Now $10 billion, smaller than $15 billion. Recall, the last two $15 billion programs, we basically also started after we sold our at a very high price and got like $21 billion, $22 billion for it with a $14 billion profit at the time. And that, of course, was then also an element of that.

現在是100億美元，少於150億美元。回想一下，最後兩個 150 億美元的項目基本上也是在我們以非常高的價格出售後開始的，當時我們獲得了 210 億美元、220 億美元的收益，利潤為 140 億美元。當然，這也是其中的一個因素。

So I would say we're always kind of returning back to the prior $10 billion share buyback rhythm we had. And also, we want to have a balance here. We continue to look, of course, after bolt-ons it's not for lack of trying any risk averseness, we would like to find more bolt-on M&A opportunities to continue to further strengthen our pipelines. But we strongly feel that a $10 billion over 2.5 years is a nice balance versus also BD&L and M&A. And from that standpoint, I feel it's a good element of continued balanced capital allocation.

所以我想說，我們總是會回到之前 100 億美元股票回購的節奏。而且，我們希望在這裡取得平衡。當然，在進行附加投資之後，我們會繼續尋找，這並不是因為缺乏規避風險的嘗試，我們希望找到更多的附加併購機會，以繼續進一步加強我們的管道。但我們強烈感覺到，在 2.5 年內投資 100 億美元與 BD&L 和 M&A 相比是一個良好的平衡。從這個角度來看，我認為這是持續平衡資本配置的一個好因素。

Thanks, Harry.

謝謝，哈利。

Thibault Boutherin from Morgan Stanley.

摩根士丹利的 Thibault Boutherin。

Thank you. Just a question on YTB and the immune reset opportunity. So clearly strong early results. I noted that you are calling the Phase II reading out from '27 as pivotal. So if you could replicate similar results in that study, are you confident you can file from '27?

謝謝。這只是關於 YTB 和免疫重置機會的一個問題。因此早期結果顯然強勁。我注意到您稱 27 年的第二階段讀數至關重要。因此，如果您可以複製該研究中的類似結果，您是否有信心從 '27 年開始提交申請？

And then if you could just sort of frame a bit the opportunity should we think about this as for highly refractory patients. So more like a niche market? And would you have to wait for next generation, I think you mentioned bispecific or could we already see a big opportunity with the first generation CAR-T?

然後，如果您可以稍微概括一下機會，我們是否應該將其視為針對高度難治性患者。所以更像是利基市場？您是否必須等待下一代，我想您提到了雙特異性，或者我們是否已經看到第一代 CAR-T 的巨大機會？

Yes. Great questions. So right now, our assumption is in the 4 pivotal studies that with highly positive data in 2027, we could file, yes, we could file based on that data. We would still have to do randomized Phase III studies likely as well as follow-ups. But our expectation is that we could replicate this level of results we would be able to file off of that data.

是的。很好的問題。因此現在，我們的假設是，在 4 項關鍵研究中，如果 2027 年獲得非常積極的數據，我們就可以提交申請，是的，我們可以根據該數據提交申請。我們可能仍需要進行隨機 III 期研究以及後續研究。但我們的期望是，我們可以複製我們能夠從該資料中歸檔的這種層級的結果。

So it does create the potential the data dependent and data-driven for launches in the 2028 time period. In terms of the market size, we're continuing to -- starting now to really do more detailed work to figure out what proportion of patients would be willing to undergo the procedures needed for card primarily the bone marrow ablation to create space for the engraftment of the CAR cells.

因此，它確實為 2028 年期間的發射創造了數據依賴和數據驅動的潛力。就市場規模而言，我們現在開始繼續做更詳細的工作，以弄清楚有多少比例的患者願意接受CAR-T所需的治療程序，主要是骨髓消融，為CAR-T細胞的植入創造空間。

So I think it's early days. Our hope is that this very much is a multibillion-dollar opportunity. And across these indications, we create a multibillion-dollar brand. And then clearly, if we're able to manage the side effect profile and make it more accessible to a broader group of those refractory patients could be even larger than that.

所以我認為現在還為時過早。我們希望這是一個價值數十億美元的機會。透過這些跡象，我們創造了一個價值數十億美元的品牌。顯然，如果我們能夠控制副作用，並讓更多難治性患者能夠接受這種療法，那麼療效可能會更好。

That's certainly the aspiration and why we go so broadly. And I think it's important to note, these are a group of patients that are no longer able to have any additional options or few additional options that generally have relatively severe outcomes. And you're seeing almost a disease if not completely reset turned back decades by this kind of therapy.

這當然是我們的願望，也是我們如此廣泛地開展工作的原因。我認為值得注意的是，這群患者已經沒有任何額外的選擇，或幾乎沒有額外的選擇，通常會導致相對嚴重的後果。而且你會看到，透過這種療法，疾病即使不能完全治愈，病情也會倒退幾十年。

So it's really a remarkable result. So we'll get a better understanding of the demand, but I would say it's a multibillion-dollar opportunity with the potential to be more based on how we see the Phase III results -- Phase II results play out.

所以這確實是一個了不起的結果。因此，我們將更好地了解需求，但我想說這是一個價值數十億美元的機會，其潛力更取決於我們如何看待第三階段和第二階段的結果。

Michael Nedelcovych from TD Cowen.

TD Cowen 的 Michael Nedelcovych。

Hi, thanks for taking my question. I have a question on the cardiovascular pipeline. At the Meet Management event late last year, Novartis expressed the ambition to have multiple arhythmia assets in the clinic by 2025. And I'm just curious if you could give us an update on that effort?

你好，謝謝你回答我的問題。我對心血管管道有疑問。在去年年底的 Meet Management 活動上，諾華表達了到 2025 年在臨床中擁有多種心律不整資產的野心。我只是好奇您能否向我們介紹這項工作的最新進展？

Yes. Great question. So we are progressing now. We are -- hopefully, we'll soon have the okay on an IND to move now into the clinic on a novel agent for control of Afib with -- so that would then enable us, hopefully, for a first patient first visit this year. And then we would hopefully have one or two additional agents may not make it this or maybe early next year, but the goal very much is to have a portfolio of agents targeting AFib and then potentially as well ventricular arrhythmias.

是的。好問題。所以我們現在正在取得進展。我們希望，我們很快就能獲得 IND 的批准，現在就可以將一種用於控制心房顫動的新型藥物帶入臨床，這樣我們就有希望在今年實現第一位患者的首次就診。然後，我們希望有一兩種額外的藥物，也許今年或明年年初無法實現，但我們的主要目標是擁有一系列針對 AFib 以及潛在的室性心律不整的藥物。

We've also signed a few licensing agreements for preclinical stage assets, which are also now advancing and so we're looking at that to accelerate those as well.

我們也簽署了一些臨床前階段資產的授權協議，這些協議目前也正在推進，因此我們也希望加速這些協議的進展。

So we see this as an area where we have unique expertise, probably one of the few companies still going after addressing cardiac arrhythmias. And obviously, if successful, market sizes here are quite large and the opportunity to use a medicine versus using the device-based cardio version is quite compelling for patients.

因此，我們認為這是我們擁有獨特專業知識的領域，可能是少數仍在致力於解決心律不整問題的公司之一。顯然，如果成功的話，這裡的市場規模相當大，而且使用藥物而不是使用基於設備的心臟版本的機會對患者來說是相當有吸引力的。

Florent Cespedes from Bernstein

伯恩斯坦公司的弗洛朗·塞斯佩德斯

A quick one on Entresto, please. Could you maybe remind us what is the next step for the US if the generic does not reach the market? When do you expect the appeal for decision? And could you remind us when is the next patent expiry and also your view on IRA?

請快速介紹一下 Entresto。您能否提醒我們，如果仿製藥不能進入市場，美國下一步該怎麼做？您預計何時會做出上訴決定？您能否提醒我們下一個專利何時到期以及您對 IRA 的看法？

Yes, Florent. So there's is many -- there's three cases ongoing. So we have the current amorphous complex case where we have a temporary preliminary injunction. We're fully briefing the court and we very much are of view that, that should be -- that preliminary injunction should be upheld. And then we would have an appeals case where we would continue to defend the amorphous complex patent.

是的，弗洛朗。因此有很多——目前有三起案件正在審理中。因此，我們目前面臨一個無定形的複雜案件，其中我們有一個臨時初步禁令。我們正在向法庭全面匯報，我們非常贊同應該維持初步禁令。然後我們會提起上訴，繼續捍衛無定形複合專利。

We have ongoing litigation on the FDA's label carve-out and whether that label carve-out is appropriate. And so that appeal is ongoing as well. We have the topic as well, where we continue to look at our options on the And this is all with respect to 1 generic filer given that all of the other generic filers have settled with us. And so that's where we stand very difficult for me to comment on time lines.

我們正在就 FDA 的標籤豁免以及該標籤豁免是否合適進行訴訟。因此，這項呼籲仍在持續進行。我們也有這個主題，我們繼續研究我們的選擇，這一切都與 1 個通用文件提交者有關，因為所有其他通用文件提交者都已與我們達成和解。所以，我們現在的處境讓我很難對時間表發表評論。

I think at this point, we will see and if there's a material update, we will update you accordingly. I think on the IRA topic, we continue to expect Entresto to face the as planned, IRA in 2026. -- we can say that the IRA pricing is in line with our current net pricing overall.

我認為現在我們會看到，如果有重大更新，我們會相應地更新。我認為在 IRA 主題上，我們繼續預期 Entresto 將按計劃在 2026 年面臨 IRA。 ——我們可以說 IRA 定價與我們目前的淨定價大致一致。

So from a pricing standpoint, if we were able to maintain Entresto into 2026, given all the legal proceedings, our net pricing would continue to be in the range of where we are this year. So the upside that Harry outlined would continue for every month that Entresto those on the market, independent of the IRA, broadly speaking, with some nuances, of course.

因此，從定價的角度來看，如果我們能夠將 Entresto 維持到 2026 年，考慮到所有的法律訴訟，我們的淨定價將繼續保持在今年的水平範圍內。因此，哈利概述的上升趨勢將持續每個月，即 Entresto 在市場上的持續成長，與 IRA 無關，廣義上講，當然也有一些細微差別。

Harry, anything you'd want to add?

哈利，你還有什麼要補充的嗎？

No, it was, perfectly correct. Thank you very much.

不，完全正確。非常感謝。

Perfect. Thank you. Thank you very much.

完美的。謝謝。非常感謝。

Seamus Fernandez from Guggenheim

古根漢美術館的謝默斯‧費爾南德斯

So I noticed the update on HHS as it relates to the ianalumab opportunity. Can you just help us understand how you're thinking about the overall B-cell opportunity here in other conditions, particularly as it relates to Sjogren's disease as we advance their? But also, do you feel that there is a unique opportunity from your learnings in that program for B-cell targeted therapies in HS specifically? Thanks so much.

因此，我注意到了 HHS 上與 ianalumab 機會相關的更新。您能否幫助我們了解您如何看待其他情況下的整體 B 細胞機會，特別是與乾燥症相關的機會？但是，您是否覺得從該計畫中獲得的知識對於 HS 的 B 細胞標靶治療具有獨特的機會？非常感謝。

Yes. Thanks, Seamus. So while we continue to pursue remibrutinib in HS and ianilimab, we didn't see the compelling results we had expected. The reason we had thought that there could be an opportunity as we do see upregulation in patients -- in HS lesions. So we thought there could be an opportunity there.

是的。謝謝，西莫斯。因此，雖然我們繼續在 HS 和 ianilimab 中研究 remibrutinib，但我們並沒有看到預期的令人信服的結果。我們之所以認為可能存在機會，是因為我們確實看到患者——HS 病變中的上調。所以我們認為那裡可能存在機會。

But it's important to note that we did not have Phase II data or proof of concept data per se that really supported that. It was more a hypothesis. And so it doesn't really shift our conviction on Sjogren's disease on lupus nephritis on SLE or on the multiple ITP indications and autoimmune hemolytic anemia indications that we have ongoing.

但值得注意的是，我們並沒有第二階段的數據或概念驗證數據本身來真正支持這一點。這更像是一個假設。因此，它並沒有真正改變我們對乾燥症、狼瘡性腎炎、系統性紅斑狼瘡或我們正在進行的多種 ITP 適應症和自體免疫性溶血性貧血適應症的信念。

So we continue to see those as all B-cell-driven diseases and where we think that tissue-resident B cells, which is particularly where ianalumab targeting anti-BAF monoclonal antibody would be effective.

因此，我們繼續將這些視為所有由 B 細胞驅動的疾病，我們認為組織駐留 B 細胞，特別是針對抗 BAF 單株抗體的 ianalumab 會有效。

Now to your question more broadly, certainly, we're learning a lot between remibrutinib as an oral BTK anti-BAF with ianilumab, our program on immune reset with YTB, our emerging programs on bispecifics on truly trying to get to the next generation of B-cell management and B-cell control.

現在更廣泛地回答您的問題，當然，我們正在學習很多東西，包括雷米布替尼作為口服 BTK 抗 BAF 與伊尼魯單抗、我們與 YTB 的免疫重置計劃、我們新興的雙特異性計劃，真正嘗試進入下一代 B 細胞管理和 B 細胞控制。

Clearly, anti-CD20s have set the foundation here. But the opportunity here is, as we get smarter about all of the B-cell lineages and understanding which lineages we want to affect in different diseases, we have the opportunity, obviously, to have better and better disease control.

顯然，抗 CD20 在此奠定了基礎。但這裡的機會是，隨著我們對所有 B 細胞譜系的了解越來越深入，並了解我們想要在不同疾病中影響哪些譜系，我們顯然有機會更好地控制疾病。

So we definitely do learn a lot. We run many of these programs as basket studies to try to get as much information and data as possible. As I said, I think we'll learn a lot in the coming years between ianalumab, the remubrutinib program and the YTB program, and that hopefully will then inform the next generation of medicines once we get those medicines through pivotal studies.

所以我們確實學到了很多。我們將許多此類項目作為籃子研究來運行，以嘗試獲取盡可能多的信息和數據。正如我所說，我認為我們將在未來幾年從 ianalumab、remubrutinib 計畫和 YTB 計畫之間學到很多東西，並希望一旦我們透過關鍵研究獲得這些藥物，這些知識將為下一代藥物提供資訊。

Rajesh Kumar from HSBC

匯豐銀行的 Rajesh Kumar

Hi there, thanks for taking my question. Just in terms of capital allocation, I appreciate that you're doing a share buyback at the moment. How much during the same period would you allocate for M&A? And just thinking through the current valuations, clearly, there would be assets which are complementary to your portfolio, which might be available at more attractive valuation right now. So can you run us through the rationale of prioritizing a share buyback increase over capital allocation towards M&A at this junction?

您好，感謝您回答我的問題。就資本配置而言，我很欣賞您目前正在進行股票回購。在同一時期，您會分配多少資金用於併購？只要考慮當前的估值，顯然就會存在一些與您的投資組合互補的資產，這些資產現在的估值可能會更具吸引力。那麼，您能否向我們解釋一下，在這個關鍵時刻，優先增加股票回購而不是進行併購資本配置的理由？

Thanks for the question, Rajesh. Harry?

謝謝你的提問，Rajesh。哈利？

Yes. Thank you, Rajesh. We are not prioritizing share buybacks over a bolt-on M&A. We are constantly -- and our team is -- we have an excellent BD&L and M&A team that has done over 30 deals over the last 2 years. We're also happy to look at the bigger bolt-ons.

是的。謝謝你，拉傑什。我們不會優先考慮股票回購而不是附加併購。我們始終如一——我們的團隊也是如此——我們擁有一支優秀的 BD&L 和 M&A 團隊，在過去 2 年中完成了 30 多筆交易。我們也很高興看到更大的螺栓。

If they're available to have great assets. So look, we have $16-plus billion free cash flow growing clearly as we go forward.

如果他們有能力擁有大量資產。所以，看，隨著我們前進，我們有超過 160 億美元的自由現金流，而且還在明顯成長。

And with the dividend level we have, we have only onetime net debt over our balance sheet has a significant flexibility and if you call it, so firepower. So if we find an attractive asset at an attractive price that is creating a likely very good return for our shareholders, we will try to get that asset. So it's not for lack of trying. So we are not prioritizing share buybacks over bolt-on M&A at all. It is about how much can we find in terms of excellent assets that would support our --

在我們現有的股利水準下，我們的資產負債表上只有一次性淨債務，具有很大的靈活性，如果你稱之為火力。因此，如果我們發現一項具有吸引力且價格誘人的資產，而該資產很可能為我們的股東帶來非常好的回報，我們就會嘗試獲得該資產。所以這並不是因為缺乏嘗試。因此，我們根本不會優先考慮股票回購而不是附加併購。關鍵在於我們能找到多少優質資產來支持我們的--

Thanks Harry

謝謝哈利

(Operator Instructions)

（操作員指示）

Simon Baker of Sheldon company.

謝爾頓公司的西蒙貝克。

Thanks for taking my second question. I just wanted to return to a comment you made about pricing outside the US and moves to stop clawback. There seems to be quite a lot of activity from your peers with respect to that in the UK at the moment, either directly or indirectly to reform I just wonder if you could give us an update on what you've been participating in and learning about potential changes in the U.K.? Thanks so much.

感謝您回答我的第二個問題。我只是想回到您關於美國以外定價和停止追回措施的評論。目前，您的同行似乎在英國採取了相當多的與此相關的行動，無論是直接還是間接地進行改革。我只是想知道您是否可以向我們介紹一下您所參與的活動以及您所了解的英國可能發生的變化？非常感謝。

Yes. Thanks, Simon. There's been, I think, active engagement. And we, I think, appreciate the UK government now actively looking at VPAG, which is the system they have in their -- in the UK to cap the pharmaceutical market growth and then basically ask the industry to rebate back or refund back certain levels of growth -- beyond certain levels of growth.

是的。謝謝，西蒙。我認為，我們已經積極參與了。我認為，我們讚賞英國政府現在積極研究 VPAG，這是英國的一套制度，用於限制醫藥市場的增長，然後要求該行業在超過一定增長水平時返還或退還一定數量的增長款。

And I think there have been productive engagements and discussions. I think we're still trying to work through an agreement that we think actually achieved the UK's goal of building a vibrant biopharmaceutical sector, which is the stated goal of the government at the moment, as you know, it's a very challenging environment with NICE and the overall reimbursement environment in the UK where actually, the reimbursement levels are almost at the level of middle income countries and uptake is quite slow.

我認為雙方的接觸和討論都很有成效。我認為我們仍在努力達成協議，我們認為該協議實際上實現了英國建立充滿活力的生物製藥行業的目標，這是政府目前的既定目標，如你所知，NICE 和英國的整體報銷環境非常具有挑戰性，實際上，報銷水平幾乎處於中等收入國家的水平，而且吸收速度相當緩慢。

So our goal very much as an industry is to get to a much better place. I think that's also the government's goal and the question is can we find common ground in these discussions? And so that's an ongoing process that, but yes, I think many of us are involved in or trying to shape.

因此，作為一個產業，我們最大的目標就是走向更好的境界。我認為這也是政府的目標，問題是我們能否在這些討論中找到共同點？這是一個持續的過程，但我認為我們很多人都參與其中或試圖塑造它。

Great, thank you.

太好了，謝謝。

Harry Sephton from UBS

瑞銀集團的 Harry Sephton

Brilliant, thank you very much for taking my second question. Just one on Pluvicto, please. So we saw an acceleration in growth in the second quarter over the first quarter. But presumably, PSMAfore didn't really pick up meaningfully until the end of the quarter. So just want to get your thoughts on the expectation for further acceleration in the third quarter. And then maybe just also on the average doses for Pluvicto.

太棒了，非常感謝您回答我的第二個問題。請只寫一篇關於 Pluvicto 的文章。因此，我們看到第二季的成長速度比第一季有所加快。但據推測，PSMAfore 直到本季末才真正明顯回升。所以只是想了解一下您對第三季進一步加速的預期的看法。然後也許還只是關於 Pluvicto 的平均劑量。

I think to date, we've seen that being about 4. Do you expect any difference in the earlier setting?

我認為到目前為止，我們看到的數字大約是 4。您認為早期的設定會有什麼不同嗎？

Yes, absolutely. So Harry, I think you're right that we saw the primary impact of PSMAfore, I'd say, in the last 4 to 6 weeks of Q2 when patients post the approval had gone through the necessary pretreatment procedures to be able to ultimately get the treatment. So I think we'll hopefully see a continued acceleration now over the second half of the year. So we -- I think we'd see steady growth, steady acceleration. I don't expect to see necessarily a "hockey stick," but I think it will be steady acceleration over the second half of the year, particularly as we get deeper into the community and get more and more of those community centers to move from a few patients then to hopefully, multiple patients and then hopefully, teams of patients on therapy in their clinics.

是的，絕對是。所以 Harry，我認為你是對的，我們看到了 PSMA 的主要影響，我想說，是在第二季度的最後 4 到 6 週，當時獲得批准的患者已經完成了必要的預處理程序，才能最終得到治療。因此我認為，我們希望看到今年下半年繼續加速發展。所以，我認為我們會看到穩定的成長和穩定的加速。我並不期望看到「曲棍球棒」式的成長，但我認為今年下半年將會穩步加速，特別是隨著我們深入社區，越來越多的社區中心從幾個病人發展到多個病人，然後希望發展成在診所接受治療的病人團隊。

And in terms of the average dosing level, you're correct that in the VISION setting, we were historically in the kind of 3.7 to 3.9 range, somewhere or something like that versus the 6 doses that are estimated. It's very early days, but we do see a positive trend up on the number of doses per patient, but I think we're going to have to have a couple more quarters.

就平均劑量水平而言，您說得對，在 VISION 設定中，我們的歷史劑量處於 3.7 到 3.9 的範圍內，或類似的範圍，而估計的劑量為 6 個。現在還處於早期階段，但我們確實看到每位患者的劑量呈現正向上升趨勢，但我認為我們還需要幾個季度的時間。

But we would expect that in earlier settings where patients tend to live longer, they tend to be healthier, it may not progress as quickly we hopefully will get closer and closer to the stated labeled dosing of 6 doses and that's certainly the aspiration.

但我們預計，在早期環境中，患者往往壽命更長，他們往往更健康，病情可能不會進展得那麼快，我們希望能夠越來越接近標籤上標明的 6 劑劑量，這當然是我們的願望。

And then hopefully, in HSPC, we can certainly get there given the health of those patients. I think one of the other notable things as well is that in terms of the efficacy that we're seeing, clearly going earlier, you also see a more robust effect likely because you see a better, more consistent PSMA expression and perhaps fewer cells that have mutated away from PSMA expression. And so you see that I think the robust efficacy we're seeing in PSMAfore and then the top line data on the PSMAddition.

然後希望，在 HSPC 中，考慮到這些患者的健康狀況，我們一定能夠實現這一目標。我認為另一個值得注意的事情是，就我們所看到的療效而言，顯然越早看到效果就越明顯，這可能是因為看到了更好、更一致的 PSMA 表達，而且可能還有更少的細胞因 PSMA 表達突變而消失。因此，您會看到，我認為我們在 PSMAfore 中看到了強大的功效，然後是 PSMAddition 的頂級數據。

Brilliant thank you.

非常感謝。

Kerry Holford from Berenberg

來自貝倫貝格的 Kerry Holford

My second question, a follow-up, please, on something you mentioned earlier about in the context of US politics. You mentioned a desire to look at options to go direct to patients. And I wonder if you can just be more explicit on what you're referring to?

我的第二個問題是，請就您之前提到的有關美國政治背景的問題進行後續跟進。您提到希望研究直接面向患者的選擇。我想知道您是否可以更明確地說明您所指的是什麼？

Could this be something similar to that sort of DTC strategy that we see in place in Nova and Lilly in the obesity market? And if that's what you're thinking, which of your drugs would you see as best suited to that channel?

這是否與我們在肥胖市場看到的 Nova 和 Lilly 所採用的 DTC 策略類似？如果您是這麼想的，您認為哪種藥物最適合該管道？

Yes. Thanks, Kerry. I think the -- yes, that's correct. I think the idea would be, are there ways we could give patients access to our medicines at the -- what is in effect the net price in a way that does not disrupt the overall complexities of the US pricing system.

是的。謝謝，克里。我認為——是的，正確。我認為，我們是否有辦法讓病人以淨價獲得我們的藥品，同時又不破壞美國定價體系的整體複雜性。

So it's definitely something you have to be thoughtful about.

所以這絕對是一件你必須深思熟慮的事情。

But certainly, depending on our products, depending on the product line, you have gross to nets anywhere from 50% to 70%. And so giving those discounts direct to the patient as opposed to through the various intermediaries would be a very attractive option.

但當然，根據我們的產品和產品線，毛利率與淨利率比在 50% 到 70% 之間。因此，直接向患者提供折扣而不是透過各種中介機構將是一個非常有吸引力的選擇。

But we're in the early days of evaluating. As you know, it's very product-specific. And we also have to evaluate the knock-on effects on best price and some of the impacts on other parts of the system. So we're evaluating it. And clearly, I think overall in the sector, there's certainly I think an evaluation as well to see if there's any approaches that we could work with HHS to come up with.

但我們仍處於評估的早期階段。如您所知，它是針對特定產品的。我們還必須評估對最佳價格的連鎖反應以及對系統其他部分的一些影響。所以我們正在評估它。顯然，我認為在整個領域，當然也需要進行評估，看看我們是否可以與 HHS 合作提出任何方法。

But that's certainly the idea we're moving towards. That's correct.

但這確實是我們正在努力實現的想法。沒錯。

Jane from Bank of America.

來自美國銀行的簡。

Another one on our US if I may So within the answer to the prior 2 questions, nothing that you described as the Novartis solution involves a price cut, as I understand it was the US portfolio. So just confirming that's correct. comfortable -- the reason the question obviously is the public commentary of the administration has been very around the industry coming to the table with a price solution.

如果可以的話，我想再問一個關於我們美國的問題，所以在回答前兩個問題時，您所描述的諾華解決方案並不涉及降價，因為據我了解，這是美國的產品組合。所以只是確認這是正確的。舒服——問題的原因顯然是政府的公開評論一直圍繞著業界提出價格解決方案。

So I just wanted to confirm that was correct? And then the second one was you said it could take time. Obviously, it's an unknown, but what's your best guess as to when this could get resolved? Is it in '25 or could this bleed into '26?

所以我只是想確認這是正確的嗎？然後第二個問題是你說這可能需要時間。顯然，這是一個未知數，但您猜測什麼時候可以解決這個問題？這是在 25 年發生還是會延續到 26 年？

Thank you.

謝謝。

Yes. So I think on the solutions, I mean, I think again and because of the between list price and net price, I think our goal for patients, which would perhaps be a "cut" to what the patient is paying. But we're very focused on out-of-pocket costs and improving the realized price for patients and figuring out how to reduce that.

是的。所以我認為解決方案是，我再想想，由於標價和淨價之間的差異，我認為我們對患者的目標可能是「削減」患者支付的費用。但我們非常關注自付費用以及改善患者的實際價格並找出降低成本的方法。

Because as you know, moving list prices around in the US system may not mean anything for -- likely won't mean anything for patients. So I think -- and that's I think a lot of the discussions we're having in a very productive way with HHS, how can we reduce the burden for patients out of pocket. And that's where all of our activity has been overall.

因為如你所知，在美國體系中調整標價可能對病人沒有任何意義。所以我認為——我認為我們正在與衛生與公共服務部進行許多富有成效的討論，討論如何減輕患者的自付負擔。這就是我們所有活動的整體情況。

Now I think in terms of resolution, it's very, very difficult to say. I really have no idea. I mean, I think there's multiple efforts ongoing, using different approaches that I think HHS is thinking through and we're trying to support as best we can, but impossible to say when exactly because clearly, doing any of these things requires significant shifts in rule-making in some of the knock-on effects across the system, not at all straightforward to do overnight.

現在我認為就分辨率而言，這很難說。我真的不知道。我的意思是，我認為我們正在進行多項努力，採用不同的方法，我認為衛生與公眾服務部正在考慮這些方法，我們也在盡力提供支持，但無法確切說明具體時間，因為很明顯，做任何這些事情都需要在規則制定方面做出重大轉變，從而對整個系統產生連鎖反應，而這並不是一夜之間就能完成的。

So it would require policy changes at HHS would likely have to make as well. And until the plan is clarified, I think even that process can't get started. So I think it's going to take time. We might have the beginnings of what we would want to do in the coming quarters, but then actually implementing it and then rolling it out, will take, certainly, I believe, will take time.

因此，衛生與公眾服務部也可能必須做出政策改變。我認為，在計劃明確之前，這一進程甚至無法啟動。所以我認為這需要時間。我們可能已經開始計劃在未來幾季內要做的事情，但實際上實施並推廣它需要時間，我相信這肯定需要時間。

Very good. Well, thanks, everybody, for joining today's call and look forward to updating you then in quarter 3 or when we run into each other at various other conferences, meetings, et cetera. Thank you, again.

非常好。好吧，謝謝大家參加今天的電話會議，並期待在第三季或我們在其他各種會議等見面時向大家通報最新情況。再次感謝您。

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

謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。