Novartis AG (NVS) 2025 Q1 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q1 2025 results release conference call and live webcast. Please note that you're in the presentation. All participants will be in a listen-only mode and the conference is being recorded. (Operator Instructions)

早上好，下午好，歡迎參加諾華 2025 年第一季業績發布電話會議和網路直播。請注意您正在參加演示。所有參與者將處於只聽模式，會議將被錄音。（操作員指示）

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

電話會議結束後不久，包括問答環節在內的電話會議錄音將在我們的網站上發布。

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, Heidi. Good morning and good afternoon, everyone, and welcome to our Q1 2025 earnings call. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.

謝謝你，海蒂。大家早安，下午好，歡迎參加我們的 2025 年第一季財報電話會議。今天提供的資訊包含前瞻性陳述，涉及已知和未知的風險、不確定性和其他因素。這些可能導致實際結果與此類聲明表達或暗示的任何未來結果、績效或成就有重大差異。

For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K that respectively were filed with and furnished to the US Securities and Exchange Commission.

有關這些因素的描述，請參閱該公司向美國證券交易委員會提交的 20-F 表格和 6-K 表格上的最新季度業績。

Before we get started, I just want to reiterate Heidi's guidance. For our analysts, please limit yourselves to one question at a time, and we'll cycle through the queue as many times as we can.

在我們開始之前，我只想重申海蒂的指導。對於我們的分析師，請限制自己一次只提出一個問題，我們會盡可能循環隊列。

And with that, I will hand over to Vas.

說完這些，我將把權交給 Vas。

Thank you, Sloan, and thanks, everyone, for joining today's conference call.

謝謝斯隆，也謝謝大家參加今天的電話會議。

If we can move forward to slide 4. Novartis delivered double-digit sales growth in the quarter, really strong start to the year. We had robust margin expansion, and that all supported an upgrade to our full-year 2025 guidance, which Harry will go through in more detail.

如果我們可以前進到幻燈片 4。諾華本季的銷售額實現了兩位數成長，為今年的開局增添了強勁動力。我們的利潤率強勁成長，這一切都支持我們在 2025 年提升全年業績預期，Harry 將對此進行更詳細的介紹。

Sales were up 15%; core operating income, up 27%. Our core margin reached 42.1%, up 400 basis points. And we also had important innovation highlights in the quarter, some of which I'll go through in detail in a moment.

銷售額成長了15%；核心營業收入成長27%。我們的核心利潤率達到42.1%，上升了400個基點。本季我們還有一些重要的創新亮點，稍後我將詳細介紹其中的一些。

Pluvicto, Vanrafia, and Fabhalta all achieved approvals in the relevant indications. We have a global submission for remibrutinib in CSU, and our OAV101 IT gene therapy for patients with SMA older than two years of age had a positive readout and we're in process now of filing that globally. So taken together, a very strong start to the year.

Pluvicto、Vanrafia和Fabhalta都獲得了相關適應症的批准。我們已經在 CSU 提交了 remibrutinib 的全球申請，並且我們針對兩歲以上 SMA 患者的 OAV101 IT 基因療法獲得了積極的讀數，我們目前正在全球提交該申請。總的來說，今年的開局非常強勁。

And going into a little bit more detail, starting on slide 5. We had strong growth momentum from all of our priority brands in the quarter. And I think that really demonstrates the replacement power, which gives us confidence in our midterm guide of 5% plus and also our confidence that we have, the levers that we need to continue to grow into the 2030s. You can see strong growth of 32% constant currency, excluding Entresto, the portfolio was up 38%.

從第 5 張投影片開始，我們將進行更詳細的介紹。本季度，我們所有重點品牌均呈現強勁成長動能。我認為這確實證明了替代能力，這讓我們對 5% 以上的中期指導充滿信心，也讓我們相信我們擁有在 2030 年代繼續增長所需的槓桿。您可以看到以固定匯率計算的 32% 的強勁成長，不包括 Entresto，投資組合成長了 38%。

And I wanted to go through on each of these key brands, some of the key highlights. So moving to slide 6. So Kisqali grew 56% in constant currency, and that reflects our positioning globally. It reflects our positioning as the preferred CDK4/6 inhibitor in both metastatic and early breast cancer. You can see that the growth was strong both outside of the United States and in the US.

我想介紹每個主要品牌的一些主要亮點。現在轉到投影片 6。因此，以固定匯率計算，Kisqali 成長了 56%，這反映了我們的全球定位。它反映了我們作為轉移性和早期乳癌首選 CDK4/6 抑制劑的定位。您可以看到，美國境外和美國境內的成長都很強勁。

I'll go through that in a bit more detail in a moment. In the central panel, you can see that our total brand NBRx now is market-leading, trending very strongly, really powered by the early breast cancer launch, which is leading to strong performance both in early breast cancer and metastatic breast cancer.

我稍後會更詳細地講解這一點。在中央面板中，您可以看到我們的整個品牌 NBRx 現在處於市場領先地位，趨勢非常強勁，這主要得益於早期乳癌的推出，這在早期乳癌和轉移性乳癌方面都表現強勁。

Now turning to each region. In the US, we were up 87% in the quarter. We have leading share in metastatic NBRx now at 48%. And that's -- we're also now tied for TRx leadership, really demonstrating now those NBRxes are impacting our TRx growth. In early breast cancer, our NBRx grew 65% and we reached 60% NBRx share. And what's important to note here is 56% of that volume, we estimate is from the population that's exclusive to the Kisqali label.

現在轉向各個地區。在美國，我們本季的銷售額成長了 87%。目前，我們在轉移性 NBRx 領域的份額領先，為 48%。那就是——我們現在也與 TRx 領導地位並駕齊驅，這真正證明了那些 NBRx 正在影響我們的 TRx 成長。在早期乳癌中，我們的 NBRx 增加了 65%，並且達到了 60% 的 NBRx 份額。這裡值得注意的是，我們估計其中 56% 的銷售來自只使用 Kisqali 品牌的人。

Now outside of the US, we're still in the early stages of the early breast cancer launch. We were up 24% in constant currency. We're the metastatic breast cancer leader in 10 of our top countries with 46% share, our NBRx share at 35% TRx share. And our early breast cancer indication has now improved in the EU plus nine other countries.

目前，在美國以外，我們仍處於早期乳癌研究的早期階段。以固定匯率計算，我們的利潤成長了 24%。我們是轉移性乳癌領域的領導者，在排名前 10 的國家中佔有 46% 的份額，我們的 NBRx 份額為 35% TRx 份額。目前，歐盟和其他九個國家的早期乳癌指徵已經得到改善。

And I think you all know, we have strong guidelines support with Category 1 NCCN guideline, and we've also achieved very strong guidelines as well with ESMO. So overall, we're really pleased with the performance of Kisqali as it continues to grow towards our peak sales guidance of $8 billion plus.

我想大家都知道，我們擁有 1 類 NCCN 指南的強大支持，並且我們還獲得了 ESMO 的非常強大的指導方針。總體而言，我們對 Kisqali 的表現感到非常滿意，因為它繼續朝著我們預期的 80 億美元以上的高峰銷售目標成長。

Now moving to slide 7. Kesimpta grew 43% in constant currency. It's outpacing both the B-cell and MS market. Our overall sales were robust, both in the US and ex-US markets. In the US, 41% TRx growth. We're outpacing the B-cell and MS markets, as I mentioned, in the US. Outside of the US, we have leading NBRx share in 8 out of 10 major markets really reflecting the ease of use of the medicine.

現在轉到投影片 7。以固定匯率計算，Kesimpta 成長了 43%。它的發展速度超過了 B 細胞和 MS 市場。我們的整體銷售業績強勁，無論是在美國或美國以外市場。在美國，TRx成長了41%。正如我所提到的，在美國，我們的發展速度超過了 B 細胞和 MS 市場。在美國以外，我們在 10 個主要市場中的 8 個擁有領先的 NBRx 份額，這真正反映了該藥物的易用性。

We continue to generate further long-term data to support the profile of Kesimpta. Seven-year data was presented at AAN, which reinforced the benefit risk profile of the medicine. And as a reminder, we continue to believe the profile of Kesimpta with convenient at-home self-administration makes it the preferred medicine for patients who don't want to have IV administration at a doctor's office.

我們將繼續產生更多長期數據來支持 Kesimpta 的概況。AAN 上展示了七年的數據，強化了該藥物的效益風險狀況。需要提醒的是，我們仍然相信 Kesimpta 方便在家中自行給藥的特性使其成為不想在醫生辦公室進行靜脈注射的患者的首選藥物。

So I think that really positions us well outside the US and in a large segment inside the U.S., where there continues to be robust growth of B-cell therapies, which we plan to participate in.

因此，我認為這確實使我們在美國以外以及美國國內的很大一部分市場中佔據了有利地位，美國的 B 細胞療法繼續保持強勁增長，我們計劃參與其中。

Now moving to slide 8. Pluvicto grew 21% in quarter one. And most importantly for us, we laid the foundation -- continue to lay the foundation for our pre-taxane launch with the PSMAfore population. When you look at some of the dynamics for Pluvicto, first, with the post-taxane setting, we have now leading NBRx share in the first-line vision population setting, so post-taxane at 40%. And this, I think, really demonstrates that we are getting strongly established in this post-taxane population.

現在轉到投影片 8。Pluvicto 第一季成長了 21%。對我們來說最重要的是，我們奠定了基礎——繼續為 PSMAfore 人群推出紫杉烷類藥物奠定基礎。當您查看 Pluvicto 的一些動態時，首先，在紫杉烷後設置中，我們現在在一線視力人群設置中擁有領先的 NBRx 份額，因此紫杉烷後為 40%。我認為這確實表明我們在後紫杉烷人群中已經站穩了腳跟。

Now when you look at some of the momentum we're seeing, we're seeing that we are gaining traction in the community setting with 4,000 TRxes, that's 11% up versus prior year. We also see overall, I'd say, encouraging signs that more and more community practices want to take on radioligand therapy. Outside of the US, we see continuous growth driven primarily by European markets, which are increasingly adopting RLT and also with improved pricing that we're seeing in key markets and now with an expansion in over 20-plus countries.

現在，當您看到我們所看到的一些勢頭時，我們會發現我們在社區環境中獲得了 4,000 個 TRxes 的關注，比去年增長了 11％。總體而言，我想說，我們也看到令人鼓舞的跡象，即越來越多的社區實踐希望採用放射性配體療法。在美國以外，我們看到持續成長主要由歐洲市場推動，這些市場越來越多地採用 RLT，我們在主要市場也看到了定價的提高，目前業務已擴展到 20 多個國家。

And most importantly for this brand, we had the March FDA approval of the PSMAfore population, the pre-taxane population. As a reminder, Pluvicto doubled the median PFS and had a very favorable safety profile versus a daily oral ARPI.

對於這個品牌來說最重要的是，我們在三月獲得了 FDA 對 PSMAfore 人群，即紫杉烷類藥物之前人群的批准。提醒一下，Pluvicto 使中位 PFS 增加了一倍，並且與每日口服 ARPI 相比具有非常良好的安全性。

The final OS analysis for the medicine when unadjusted for crossover was 0.91, but importantly, crossover adjusted was 0.59. And that's been very well received in the community. We already have NCCN guideline support for the use of Pluvicto in this setting. We're also continuing to advance our Pluvicto life cycle management efforts. The PSMA addition readout is on track for the second half of 2025. And as a reminder, the PSMA addition incidence is similar to that we see in the pre-taxane setting.

未經交叉調整的藥物最終 OS 分析為 0.91，但重要的是，交叉調整後為 0.59。這在社區中受到了熱烈歡迎。我們已經有 NCCN 指南支援在這種情況下使用 Pluvicto。我們也持續推動 Pluvicto 生命週期管理工作。PSMA 附加數據預計在 2025 年下半年公佈。需要提醒的是，PSMA 添加發生率與我們在紫杉烷類治療前環境中看到的類似。

So moving to slide 9, just a little bit more on our preparations for the PSMAfore launch in the US. We have a strong foundation in place, 620 sites opened, large population now that we've expanded into a prefilled syringe that's enabling broad adoption is now naturally launched. 50% of PSMAfore patients are treated by HCPs who have already prescribed in the VISION population. And we're also continuing to increase and have increased our promotional spend. We've doubled our field force and are maintaining a very robust direct-to-consumer advertising campaign.

請前往投影片 9，稍微介紹一下我們為在美國推出 PSMAfore 所做的準備。我們擁有堅實的基礎，已開設了 620 個站點，用戶眾多，現在我們已擴展到能夠廣泛採用的預充式註射器，現已自然推出。 50% 的 PSMAfore 患者由已經在 VISION 族群中開立處方的 HCP 進行治療。而且我們還在持續增加並且已經增加了我們的促銷支出。我們的實地人員增加了一倍，並保持著非常強勁的直接面向消費者的廣告活動。

Now in terms of the launch dynamics we expect to see, it would take about four to seven weeks of lead time for new patients to be treated for them to get the necessary scans as well as the necessary laboratory tests to be able to receive the medicine.

現在，就我們預計看到的發布動態而言，新患者需要大約四到七週的準備時間才能接受治療，以便他們進行必要的掃描以及必要的實驗室測試，以便能夠接受藥物。

We expect initial uptake to be driven by depth in our established accounts in the VISION setting. And also, we expect to, over time, expand our breadth in the community and urology setting. So -- and as I mentioned, we also have the favorable NCCN guidelines. So I think set up well, this will really be a second half story.

我們預計，最初的吸收將由我們在 VISION 設定中已建立的帳戶的深度來推動。此外，我們希望隨著時間的推移，擴大我們在社區和泌尿科領域的服務範圍。所以 — — 正如我所提到的，我們也有有利的 NCCN 指南。所以我認為，如果設定得當，這真的會是一個後半部分的故事。

And really in the next few months, we want to ensure we start to build the momentum that will allow this brand now to break through past the $2 billion mark and then forward to the $4 billion-plus guidance that we've given.

實際上，在接下來的幾個月裡，我們希望確保開始積聚勢頭，讓這個品牌現在突破 20 億美元大關，然後朝著我們給出的 40 億美元以上的目標邁進。

Now moving to slide 10. Leqvio grew 72% in the quarter, on track to achieve blockbuster status. We have the steady march upwards that we're very pleased with. We're seeing solid growth both in the US and ex-US.

現在轉到第 10 張投影片。Leqvio 本季成長了 72%，有望獲得轟動地位。我們穩步前進，對此我們感到非常高興。我們看到美國和美國以外地區都出現了穩健的成長。

We see a steady climb in monthly TRxes. It's 70% up versus prior year, and that's growth across all of the key channels we're targeting. We're also seeing increasing depth in the priority systems that we're trying to establish the medicine. That's up 51% versus prior year. We've also evolved our field operating model to better serve physicians and systems that would like to use Leqvio to manage their patients to goal for cholesterol lowering.

我們看到每個月的交易量穩定上升。與去年相比成長了 70%，而且這是我們所針對的所有主要管道都實現了成長。我們也看到，我們試圖建立的藥物優先系統的深度正在增加。與去年同期相比成長了 51%。我們還改進了我們的現場運作模式，以便更好地服務於希望使用 Leqvio 來管理患者以降低膽固醇的醫生和系統。

Outside of the US, we're seeing robust growth across our key markets, 74% growth. I would want to highlight the solid pricing and access we've secured in Japan as well as the continued out-of-pocket expansion we're seeing in China, which I think bodes well for the future of this medicine in Asia.

在美國以外，我們的主要市場也呈現強勁成長，成長 74%。我想強調的是，我們在日本獲得了穩固的定價和管道，以及我們在中國看到的持續的自付費用擴張，我認為這預示著這種藥物在亞洲的未來前景良好。

We know there's a significant runway ahead of us. Only about 2% of secondary prevention patients receive any advanced lipid-lowering therapy. And there's increasing guideline recommendations that recommend these patients receive advanced lipid-lowering therapy. So a big market opportunity, and step by step, we're on track to fully realize the potential of this medicine.

我們知道，我們前面還有很長的路要走。只有約 2% 的二級預防患者接受了任何先進的降血脂治療。越來越多的指引建議建議這些患者接受先進的降血脂治療。因此，這是一個巨大的市場機遇，我們正一步步走上充分發揮這種藥物潛力的道路。

And moving to slide 11. Now Scemblix, as you know, has established itself as a leader in the third line plus setting. And now our focus is switched to really establishing the medicine in earlier lines given our recent approvals. Now in the third-line setting, we are up at 54% NBRx share. We're 3 times higher than the next competitor, reflecting the excellent profile of Scemblix.

移至第 11 張投影片。現在，如您所知，Scemblix 已經成為第三線以上設定的領導者。鑑於我們最近獲得的批准，現在我們的重點轉向在早期階段真正建立藥物。現在在第三線設定中，我們的 NBRx 份額已上升至 54%。我們比下一個競爭對手高出 3 倍，體現了 Scemblix 的優秀形象。

Outside of the US, in key markets, 68% in Japan and 47% in Germany for NBRx share and an overall share of 47%. So I think really well positioned now in the third-line setting.

在美國以外的主要市場中，NBRx 在日本的份額為 68%，在德國的份額為 47%，總體份額為 47%。所以我認為現在在第三線設定中處於非常有利的位置。

So our focus has shifted to driving our performance in earlier lines. We see continued momentum in the US. We have a very strong start building off the NCCN guidelines for our Category 1 preferred recommendation. We have 54% of commercial lives covered now to label. We're seeing expanding prescriber drafts, 16% versus prior quarter, and a strong uptake in second line where we've already achieved 40% share and steady progress as well in first line, where we have 10% NBRx share.

因此，我們的重點已轉移到推動早期產品線的業績。我們看到美國的發展勢頭持續。我們已經根據 NCCN 指南為我們的 1 類首選建議做好了充分的準備。我們現在已涵蓋了 54% 的商業生活。我們看到處方藥數量正在擴大，與上一季度相比增長了 16%，二線藥物的吸收量強勁增長，我們已經取得了 40% 的份額，一線藥物也取得了穩步進展，我們擁有 10% 的 NBRx 份額。

And as a reminder, we are of course working against generic imatinib and the generic second-generation TKIs. But we feel confident that step-by-step, we'll continue to be able to take significant share from those medicines. Our early line approvals are on track globally. We have already approval in 10 countries, and our submission is now completed in Europe.

需要提醒的是，我們當然正在努力對抗仿製伊馬替尼和仿製第二代 TKI。但我們堅信，我們將能夠逐步地從這些藥品中佔據相當大的份額。我們的早期生產線審批在全球範圍內進展順利。我們已經在 10 個國家獲得批准，並且我們在歐洲的提交現已完成。

So moving to slide 12 and turning to Cosentyx. Cosentyx grew 18% on the quarter. It was driven by both our launches in HS and IV, but also importantly, very good performance in our core indications. In the US, we saw a strong demand growth, 29%, more than offsetting the expected impact of the Part D redesign. Our NBRx volume is outperforming the market in our core indications, 15% versus market in psoriasis, 12% in the spondyloarthropathies. And we help have continued NBRx leadership in HS at 53%, even in the face of a new competitor entry.

因此移至投影片 12 並轉向 Cosentyx。Cosentyx 本季成長了 18%。這是由我們在 HS 和 IV 領域的發布所推動的，但同樣重要的是，我們在核心適應症方面的表現非常好。在美國，我們看到了強勁的需求成長，成長了 29%，超過了 D 部分重新設計的預期影響。我們的 NBRx 銷售在核心適應症方面優於市場，在牛皮癬方面優於市場 15%，在脊椎關節病方面優於市場 12%。即使面對新的競爭對手，我們仍幫助 NBRx 繼續在 HS 領域保持 53% 的領先地位。

Now when you look at the IV formulation, we have 1,900 accounts using the medicine. That's a 13% growth. I think it's still early stages for the IV launch, but we're confident that step by step, now that we have the relevant reimbursement and support in place, that the IV launch can also accelerate over the years to come.

現在，當您查看 IV 配方時，我們有 1,900 個帳戶使用該藥物。這是一個13%的成長。我認為 IV 的推出仍處於早期階段，但我們相信，隨著相關報銷和支援的到位，IV 的推出也將在未來幾年內逐步加速。

Outside the US, we delivered 15% volume growth, mainly in the core indications. We're the leading originator biologic now in Europe and China, and we've also achieved now HS reimbursement across our key markets. So taken together, we're confident in continued growth. We are on track to get the Phase III readouts in both GCA and PMR, and we're also well prepared to launch in those indications when and if approved.

在美國以外，我們的銷量成長了 15%，主要集中在核心適應症方面。我們目前是歐洲和中國領先的原創生物製劑，並且我們還在主要市場實現了 HS 報銷。總的來說，我們對持續成長充滿信心。我們預計將獲得 GCA 和 PMR 的 III 期讀數，並且我們也已做好充分準備，在獲得批准後推出這些適應症。

Now moving to slide 13. And now turning to Entresto, which continues to have strong performance at 22% growth, you can see here in the quarter, reaching over $2.2 billion in global sales. We expect continued growth in the US up until LOE and we continue to guide to a mid-2025 LOE, but we can get into that in more detail on the call. But in terms of outside the US, we have a very strong guideline position.

現在轉到第 13 張投影片。現在來看看 Entresto，它繼續保持強勁成長勢頭，本季全球銷售額達到 22 億美元以上。我們預計美國經濟將持續成長直至 LOE，並且我們將繼續預測 2025 年中期的 LOE，但我們可以在電話會議上更詳細地討論這個問題。但就美國以外而言，我們擁有非常強大的指導地位。

We have balanced geographic sales with 50% of our sales outside of the US. We expect RDP protection in Europe to November 2026. And also, of course, we'll continue to pursue other avenues to fully protect the medicine in Europe. June 2030 in Japan with possible additional protections as well. And I would say that the hypertension indication is performing extremely well in China and Japan, and the possibility for that to drive our growth towards through the end of the decade is something we're continuing to remain focused on.

我們的銷售地理均衡，50% 的銷售額來自美國以外。我們預計歐洲的 RDP 保護將持續到 2026 年 11 月。當然，我們也將繼續尋求其他途徑來全面保護歐洲的藥品。2030 年 6 月日本也可能採取額外的保護措施。我想說的是，高血壓適應症在中國和日本表現得非常好，這有可能推動我們在本世紀末實現成長，這是我們將繼續關注的事情。

Now moving to slide 14. I did want to say a word about our renal portfolio. As you know, we've been building out a strong renal portfolio around the globe. We have the ongoing launch now of Fabhalta and the recent approval of an Vanrafia. When you look at Fabhalta, our IgAN, we've already seen 100% volume growth and 60% increase in riders versus the prior quarter.

現在轉到投影片 14。我確實想談談我們的腎臟投資組合。如您所知，我們一直在全球範圍內建立強大的腎臟產品組合。我們現在正在推出 Fabhalta，並且最近還批准了 Vanrafia。當您查看我們的 IgAN Fabhalta 時，我們已經看到與上一季相比，交易量增加了 100%，乘客數量增加了 60%。

I think that reflects the excitement around the impact the medicine could have for these patients. We have over 90% of patients remaining on treatment out at five months. We have 68% commercial coverage to label. And in C3G, while we're only improved in March, we already see positive signs, over 2,000 physicians are REMS-certified, and that's applicable across both indications.

我認為這反映了人們對這種藥物可能對這些患者產生的影響的興奮。我們有超過 90% 的患者在五個月內仍繼續接受治療。我們有 68% 的商業標籤覆蓋率。在 C3G 方面，雖然我們在 3 月才有所改善，但我們已經看到了積極的跡象，超過 2,000 名醫生獲得了 REMS 認證，這適用於這兩種適應症。

Now Vanrafia was approved by FDA in April, once-a-day nonsteroidal oral treatment. What's exciting about this medicine is from an efficacy standpoint, it can be seamlessly added on to existing RAS inhibitors that a patient may be on without any discontinuation needed. But also importantly, there was no REMS for the label for hepatotoxicity or pregnancy. So a nice clean label as well, which was the business case for this medicine. So we really have now a safe, effective oral medicine to be given for the management of the endothelium and the kidney with this medicine.

目前，Vanrafia 已於 4 月獲得 FDA 批准，是一種每日一次的非類固醇口服治療藥物。這種藥物令人興奮的地方在於，從療效的角度來看，它可以無縫添加到患者正在服用的現有 RAS 抑制劑中，而無需停藥。但同樣重要的是，標籤上沒有針對肝毒性或妊娠的 REMS。因此，這也是一個很好的乾淨的標籤，這是這種藥物的商業案例。因此，我們現在確實有了一種安全有效的口服藥物，可以用來治療內皮細胞和腎臟。

So overall, we're driving strong synergies across this portfolio, and our aspiration will be to continue to build out the strength of our renal pipeline to really ensure we can establish ourselves as a long-term renal leader.

因此，總體而言，我們正在推動整個產品組合的強大協同效應，我們的願望是繼續增強我們的腎臟產品線實力，以真正確保我們能夠成為長期的腎臟領導者。

Now moving to slide 15. I did want to say a word about the OAV101 IT gene therapy readout that we had in the quarter. So looking at the left-hand part of the slide, you can see the primary endpoint was achieved in patients 2 to 18 years of age.

現在翻到第 15 張投影片。我確實想談談我們本季的 OAV101 IT 基因治療讀數。因此，請查看幻燈片的左側部分，您可以看到 2 至 18 歲的患者達到了主要終點。

But I wanted to focus in on the patients 5 to 18 years of age, particularly given that Zolgensma has been in the market for some period of time. The treatment effect versus placebo of 2.45 is really very strong and, I think, differentiating versus competition and positions us well, we believe, to get both hopefully the approval and ultimately payer support for the use of this onetime therapy in patients 5 to 18 years of age.

但我想重點關注 5 至 18 歲的患者，特別是考慮到 Zolgensma 已經上市一段時間了。與安慰劑相比，2.45 的治療效果確實非常強，我認為，與競爭對手相比，這讓我們處於有利地位，我們相信，我們希望獲得批准，並最終獲得付款人的支持，用於 5 至 18 歲的患者使用這種一次性療法。

And so we're excited about the SEER and STRENGTH studies, the overall favorable safety profiles we've been able to deliver with the medicine. And as I mentioned, we're on track for global regulatory submissions over the course of the first half of 2025.

因此，我們對 SEER 和 STRENGTH 研究感到非常興奮，我們已經能夠透過藥物提供整體良好的安全性。正如我所提到的，我們將在 2025 年上半年按計畫提交全球監管文件。

So moving to the next slide. Also from a clinical data standpoint, we did have long-term data on remibrutinib in CSU, which we think further supports the differentiated profile of the medicine. Strong efficacy was maintained out to 52 weeks even as the placebo group cross over onto active 25 milligrams BID. You can see that we have meaningful improvements in symptom control across all measures.

請轉到下一張投影片。此外，從臨床數據的角度來看，我們確實擁有關於瑞布替尼在 CSU 中的長期數據，我們認為這進一步支持了該藥物的差異化特性。即使安慰劑組轉為每日兩次服用 25 毫克活性藥物，其強效療效仍維持長達 52 週。您可以看到，我們在所有措施的症狀控制方面都取得了有意義的進展。

But I think really importantly, that symptom control starts as early as week one in a highly symptomatic disease, where itch can lead to disruption and quality of life and quality of sleep. Patients want something that will hopefully impact their disease very soon after initiating a therapy.

但我認為真正重要的是，對於症狀嚴重的疾病，症狀控制早在第一週就開始了，搔癢會導致生活品質和睡眠品質的紊亂。患者希望得到一些能夠在開始治療後很快對其病情產生影響的藥物。

We also had a very favorable safety profile in the data set, including balanced LFTs. I can say that in our mid-cycle review, we did not receive any questions from FDA with respect to the liver profile of the medicine. So I think in CSU, that bodes well for the profile of remibrutinib.

我們在資料集中也獲得了非常有利的安全性，包括平衡的 LFT。我可以說，在我們的中期審查中，我們沒有收到 FDA 關於該藥物肝臟特性的任何疑問。因此我認為在科羅拉多州立大學，這預示著瑞布替尼的前景良好。

We continue to achieve our key milestones. We had the New England Journal of Medicine publication. We've completed submissions now in the US, EU, and China. We've initiated a head-to-head study versus dupilumab with a readout expected in 2027, where we'll focus very much on the speed of onset of action of remibrutinib. And we continue to advance a full range of indications.

我們繼續實現我們的關鍵里程碑。我們有《新英格蘭醫學雜誌》出版品。我們目前已在美國、歐盟和中國完成提交。我們已啟動與 dupilumab 的頭對頭研究，預計 2027 年將獲得結果，我們將重點放在 remibrutinib 的起效速度。我們將繼續推進全方位的適應症治療。

Our Phase III in chronic inducible urticaria is ongoing and targeted for a 2026 submission. We've initiated our HS Phase III study. We also have Phase IIa/b studies ongoing for food allergy, where a readout is expected in the second half of this year.

我們針對慢性誘發性蕁麻疹的 III 期臨床試驗正在進行中，計劃於 2026 年提交申請。我們已經啟動了 HS 第三階段研究。我們也正在進行食物過敏的 IIa/b 期研究，預計今年下半年將得出結果。

And as you all know, at a higher dose, we also are looking at, in neuroscience, at relapsing MS as well as myasthenia gravis. So the next milestone for us will be an FDA decision on CSU in the second half of the year.

眾所周知，在神經科學領域，我們也正在研究較高劑量下復發性多發性硬化症以及重症肌無力。因此，我們的下一個里程碑將是 FDA 在今年下半年對 CSU 做出的決定。

So moving to slide 17, taken all together, are on track for our innovation milestones for the year. We'll continue to keep you updated as we continue to get readout, but importantly as well, the progress on our early and mid-stage pipeline, which we believe will generate the replacement power to enable us to grow strongly into the next decade.

因此，轉到第 17 張投影片，總的來說，我們今年的創新里程碑已步入正軌。我們將繼續向您通報最新情況，但同樣重要的是，我們早期和中期管道的進展情況，我們相信這將產生替代動力，使我們能夠在下一個十年強勁增長。

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

因此，我將把它交給哈利。

Yeah. Thank you, Vas. Good morning, good afternoon, everybody. I will now talk you through our financials for the first quarter. which reflect a very strong start to the year. 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。我現在將向大家介紹我們第一季的財務狀況。這反映出今年開局非常強勁。像往常一樣，除非另有說明，我的評論均指以固定貨幣計算的增長率。

So starting on page number 19. Net sales grew 15% in quarter one versus prior year and core operating income grew 27%. Our core margin was 42%, reflecting a 400 basis points improvement driven by the excellent sales growth and good cost management. Core earnings per share was $2.28, up 31%, and free cash flow was $3.4 billion.

從第 19 頁開始。第一季淨銷售額較上年同期成長 15%，核心營業收入成長 27%。我們的核心利潤率為 42%，得益於出色的銷售成長和良好的成本管理，利潤率提高了 400 個基點。每股核心收益為 2.28 美元，成長 31%，自由現金流為 34 億美元。

Now just to note, gross to net favorability, mainly in the US, added about 2 percentage points to growth in quarter one from gross to net true-ups based on invoices related to prior quarters in 2024. So the underlying growth in quarter one was still a very strong 13%.

現在需要注意的是，根據 2024 年前幾季的相關發票，總淨額的有利性（主要在美國）使第一季的總淨額成長增加了約 2 個百分點。因此第一季的潛在成長率仍然非常強勁，達到 13%。

On the next slide, just a focus -- short focus on free cash flow, which was up 66% in US dollars. And this is, of course, a continued area of focus for us. Our very strong ability to turn excellent core operating income growth into great free cash flow provides, of course, ample capacity to reinvest the business, to pursue bolt-on deals and return capital to shareholders while growing dividends and share buybacks.

在下一張投影片中，我們僅關注自由現金流，以美元計算，其成長了 66%。當然，這也是我們持續關注的領域。我們非常有能力將出色的核心營業收入成長轉化為巨大的自由現金流，當然，這為我們提供了充足的能力來進行業務再投資、進行附加交易和向股東返還資本，同時增加股息和股票回購。

Speaking of capital allocation, next slide, please. Yes. We remain committed to our shareholder-friendly capital allocation strategy, which optimizes both investing in the business and returning capital to shareholders. So we continue to invest in R&D and CapEx and pursue, of course, also value-creating bolt-on M&A and [BD&L] deals. For example, we recently announced a five-year $23 billion investment into our US-based manufacturing and R&D footprint, and we also closed the acquisition of Anthos Therapeutics in April.

說到資本配置，請看下一張投影片。是的。我們始終致力於股東友善的資本配置策略，既優化了業務投資，也優化了股東資本回報。因此，我們繼續投資於研發和資本支出，當然也追求創造價值的附加併購和 [BD&L] 交易。例如，我們最近宣布將在五年內向美國製造和研發部門投資 230 億美元，我們也在四月完成了對 Anthos Therapeutics 的收購。

In terms of returning capital to shareholders, we paid $7.8 billion in dividends in March and April of this year and continued our up to $15 billion share buyback in quarter one, which has approximately $2.7 billion left to be executed over the next months.

在向股東返還資本方面，我們在今年 3 月和 4 月支付了 78 億美元的股息，並在第一季繼續進行了高達 150 億美元的股票回購，其中約 27 億美元將在未來幾個月內執行。

Moving to slide 22. So our continued strong business momentum, combined with the gross to net favorability mainly in the US allowed us to raise our full year guidance to the upper end of the provided range for both top and bottom line. So we now expect sales to grow high single digits, up from mid- to high single digit. And we expect core operating income to grow low double digit, up from high single to low double digits.

移至投影片 22。因此，我們持續強勁的業務發展勢頭，加上主要在美國的毛利潤與淨利潤之間的良好關係，使我們能夠將全年業績預期提高到所提供營收和利潤範圍的上限。因此，我們現在預期銷售額將成長高個位數，從中到高個位數。我們預期核心營業收入將達到低兩位數成長，從高個位數成長至低兩位數。

Embedded in our guidance is the continued financial planning assumption that Tasigna, Promacta and Entresto would have US generic entries occurring mid of this year. And 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 in the range of 16% to 16.5%. So no change versus what we said end of January.

我們的指導中包含了持續的財務規劃假設，即 Tasigna、Promacta 和 Entresto 將在今年年中在美國上市仿製藥。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，核心稅率在 16% 至 16.5% 之間。因此與我們一月底所說的相比沒有變化。

Now to my final slide already, where we have outlined details regarding the expected currency impact. If late April rates would prevail for the remainder of 2025, we would expect the full year currency impact to be neutral on net sales and negative 2 percentage points on core operating income. As a reminder, we provide an estimated impact of exchange rates on our results on a monthly base on our website, which I hope is useful to you especially in times of a bit more volatility lately.

現在我已經看到最後一張投影片了，我們在這裡概述了有關預期貨幣影響的細節。如果 2025 年剩餘時間內 4 月底的利率維持不變，我們預期全年貨幣影響對淨銷售額的影響為中性，對核心營業收入的影響為負 2 個百分點。提醒一下，我們每月都會在我們的網站上提供匯率對我們業績的估計影響，我希望這對您有所幫助，特別是在最近波動較大的時期。

So with that, back to Vas.

那麼，回到 Vas。

Thank you, Harry. So in conclusion, on slide 25, strong start to the year with double-digit sales growth, robust core margin expansion, strong core operating income growth, strong free cash flow generation. Given that strong start, we've upgraded our guidance for the full year.

謝謝你，哈利。總而言之，在第 25 張投影片上，今年開局強勁，銷售額實現兩位數成長，核心利潤率強勁擴張，核心營業收入強勁成長，自由現金流強勁產生。鑑於這一強勁的開局，我們上調了全年業績預期。

I think importantly, significant pipeline progress in quarter one. We had three new approvals in the span of three weeks, that we believe can generate important growth for the company. And we remain confident even with the uncertainties of the geopolitical environment and achieving our mid- to long-term growth outlook as we've outlined previously.

我認為重要的是，第一季的管道取得了重大進展。我們在三週內獲得了三項新批准，我們相信這能為公司帶來重要的成長。即使地緣政治環境存在不確定性，我們仍然有信心實現我們先前概述的中長期成長前景。

So with that, I think we can open the line for questions.

因此，我想我們可以開始回答問題了。

(Operator Instructions) Simon Baker, Redburn Atlantic.

（操作員指示）西蒙·貝克，雷德伯恩大西洋公司。

A few if I may, please. Firstly, on the issue of tariffs. Most of your peers have led their quarterly presentations this time with tariffs and the impact and the correlation between where drugs are made, where they're sold. You chose not to. So I just wondered if you could give us some thoughts on the tariff exposure as you see it now.

如果可以的話，請給我一些。第一，關於關稅問題。這次，大多數同業在季度報告中都談到了關稅以及藥品產地和銷售地之間的影響和關聯。你選擇不這麼做。所以我只是想知道您是否可以就您現在看到的關稅風險給我們一些看法。

And related to that, given it's a few weeks since it was published, I wonder if you could give us some feedback on your letter with Paul Hudson to the FT. And then secondly on -- for Harry, on the gross to net positive impact of 2 percentage points. Could you give us any more color on precisely where that was disproportionately landing? I'm assuming it wasn't equally distributed across the portfolio. So a little bit of color at the drug level would be very helpful there.

與此相關，考慮到該信已發表幾週，我想知道您是否可以就您與保羅·哈德森 (Paul Hudson) 共同致英國《金融時報》的信給我們一些反饋。其次，對哈利來說，總收入對淨收入產生了 2 個百分點的正面影響。您能否向我們進一步說明這種不成比例的後果究竟發生在何處？我認為它在整個投資組合中的分佈並不均勻。因此，藥物層面的一點點顏色將會非常有幫助。

Thank you, Simon. So first on tariffs. I think as Harry noted and we noted earlier today as well, our guidance fully accounts for any potential tariffs that we've modeled or scenarios that we expect in this year and in the medium term guidance.

謝謝你，西蒙。首先談談關稅。我認為，正如哈里指出的以及我們今天早些時候也指出的那樣，我們的指導充分考慮了我們模擬的任何潛在關稅或我們預計今年和中期指導中的情景。

We've taken, I think, appropriate actions with inventory levels and in terms of managing our supply chain to enable us to feel comfortable we can manage it this year and in the medium term. As you also saw with our $23 billion investment, our goal in the coming years is to have 100% of our key US products fully produced end-to-end in the US, and we're on track to do that.

我認為，我們已經針對庫存水準和供應鏈管理採取了適當的措施，讓我們有信心在今年和中期內管理好它。正如大家在我們 230 億美元的投資中所看到的，我們未來幾年的目標是實現我們所有關鍵美國產品的 100% 完全在美國端到端生產，而且我們正在按計劃實現這一目標。

So we think it's manageable and not something that we need to highlight with respect to our financial outlook. Hence, we don't place a lot of emphasis on it. This is something we've been working on since January, and we feel good about where we are.

因此我們認為這是可控的，並且不需要在我們的財務前景中強調。因此，我們並不太重視它。這是我們自一月份以來一直在努力的事情，我們對目前的進展感到滿意。

And with respect to the latter on EU properly rewarding innovation, we believe there is an opportunity right now given the deliberations at the European Commission on how to maintain a competitive environment for the biopharmaceutical industry to hopefully make the commission consider doing something more proactive to ensure that we have a better environment in Europe.

關於後者關於歐盟適當獎勵創新的問題，我們認為，鑑於歐盟委員會正在討論如何維持生物製藥行業的競爭環境，現在有機會讓委員會考慮採取更積極主動的措施，以確保我們在歐洲擁有更好的環境。

Clearly, prices in Europe have continued to decline, no longer reflecting the innovation that we deliver. It's a combination of capping market growth, penalizing new indications. Low prices at launch has really led to 30% of medicines not being launched in Europe or being delayed in Europe. That number will only grow over time.

顯然，歐洲的價格持續下降，不再反映我們所提供的創新。這是限制市場成長和懲罰新適應症的結合。上市價格低實際上導致30%的藥品無法在歐洲上市或在歐洲上市被延後。隨著時間的推移，這個數字只會成長。

So as an industry, I think this is something we're taking up. We put forward three ideas on how we could potentially address the situation, maybe other ideas as well. And we're hopeful that the European Commission will take it up. And we'll stay determined to educate policymakers at the country level and at the commission level to really address the situation.

因此，作為一個行業，我認為這是我們正在做的事情。我們提出了三個可能解決這個問題的想法，也許還有其他想法。我們希望歐盟委員會能夠接受這個問題。我們將繼續堅定地教育國家層級和委員會層面的政策制定者，以真正解決這個問題。

Now with respect to gross to net, Harry?

現在關於毛額與淨額，哈利？

Yeah. Thank you. Thanks, Simon, for the question. Obviously, we continue to monitor. As you know, this is due to invoice.

是的。謝謝。謝謝西蒙提出的問題。顯然，我們會繼續監控。如您所知，這是由於發票造成的。

We get six to nine months late, sometimes. We try to always be on the midpoint based on latest information we get. And again, we got a bit lower Medicaid utilization and more favorable channel mix, which gives prior period adjustments, I mentioned the 2 points of impact; but of course, also informs us about future.

有時我們會晚六到九個月。我們嘗試根據所獲得的最新資訊始終處於中間點。再次，我們的醫療補助利用率略有下降，管道組合也更加有利，這給出了前期調整，我提到了兩點影響；當然，它也告訴我們未來的情況。

So also when we come to the upgrade, it's not only the prior period gross to net. It's also a better revenue deduction outlook for year to go, if you will, for the future as well as continued very good brand performance. And I think Kisqali may see fantastic performance there.

因此，當我們進行升級時，不僅僅是前期總額到淨額的升級。如果您願意的話，這也意味著未來一年的收入扣除前景會更好，品牌業績也會持續保持良好。我認為基斯卡利可能會在那裡有出色的表現。

Now in terms of -- it's really across many brands. So I don't want to call out one brand. It's not distorting growth rates very much. It's in this range of 1% to 4% or something like that. So it's not worth mentioning a single product.

現在就這一點而言——它確實涉及許多品牌。所以我不想點名某個品牌。它不會對成長率造成太大的扭曲。其範圍在 1% 到 4% 左右。因此單一產品不值得一提。

It's quite broad-based.

它的基礎相當廣泛。

Graham Parry, Bank of America.

美國銀行的格雷厄姆·帕里。

So just a follow-up on tariffs as you shared about. Your guidance -- so your midterm guidance focuses on revenue and margin. Obviously, Novartis is one of the companies that has a lower global tax rate because of the booking and profits in Switzerland. It looks like from the reports and accounts just 16.5%. That's obviously quite a long way below US corporate rate.

正如您所分享的，我只是對關稅進行了跟進。您的指導—因此您的中期指導重點在於收入和利潤。顯然，諾華公司由於在瑞士記帳並獲利，是全球稅率較低的公司之一。從報告和帳目來看，這一比例僅為 16.5%。這顯然遠低於美國企業利率。

So when you're talking about factoring this into your guidance, is that also factoring in the potential for any actions on transfer pricing or IP, patent boxes, et cetera, which would impact on tax rate as well?

因此，當您談到將此因素納入指引時，是否也考慮了對轉讓定價或智慧財產權、專利盒等採取的任何行動的可能性，這些行動也會對稅率產生影響？

Harry?

哈利？

Yeah. Graham, so we feel very confident in our tax rate and our tax planning in our transfer pricing. All of that is very robust. From that standpoint, we are at the moment in the 16% to 16.5%. This already includes Pillar II 15% minimum and, for example, Switzerland.

是的。格雷厄姆，所以我們對我們的稅率和轉讓定價的稅務規劃非常有信心。所有這些都非常強大。從這個角度來看，我們目前的比例在 16% 到 16.5% 之間。這已經包括第二支柱最低 15% 以及瑞士等國家。

So all of that, we feel is very robust. And of course, I don't want to talk about others, but overall, all of this is also OECD conformed. So from that standpoint, I believe that our tax rate will be in that range of 16% to 7% as a core tax rate.

因此，我們認為這一切都非常穩健。當然，我不想談論其他的，但總的來說，所有這些也都符合經合組織的規定。因此從這個角度來看，我認為我們的核心稅率將在 16% 至 7% 的範圍內。

And I think, Graham, of course, we don't know. We're monitoring the situation if the government were to -- the US government would have taken more extreme actions, we, of course, have to reevaluate. But based on everything we're hearing, we believe we can manage the policies that have been put forward thus far. And so we feel confident in the position we have.

我認為，格雷厄姆，當然，我們不知道。我們正在關注局勢發展，如果美國政府採取更極端的行動，我們當然必須重新評估。但根據我們所聽到的一切，我們相信我們可以管理迄今為止提出的政策。因此，我們對自己的地位充滿信心。

Emmanuel Papadakis, Deutsche Bank.

伊曼紐爾‧帕帕達基斯，德意志銀行。

Maybe a question on Pluvicto. Just firstly, a clarification. I think you mentioned this earlier, $4 billion ultimate peak sales ambition. But if I recall correctly, last year, you provided us with the $5 billion numbers. I just wanted to confirm if that had changed or that was just a typo.

也許是有關 Pluvicto 的問題。首先，需要澄清的是。我想您之前提到過這一點，即 40 億美元的最終高峰銷售目標。但如果我沒記錯的話，去年您向我們提供了 50 億美元的數字。我只是想確認一下這是否已經改變或這只是一個打字錯誤。

And then just talk to us a little bit about the confidence on H2 PSMAfore inflection. Is that really based on confidence that you're going to transcend this community referrals bottleneck? Is it actually expanding the number of sites will be capable of administering therapy? If you could provide a little bit more color that, that would be extremely helpful.

然後請與我們簡單談談對 H2 PSMA 拐點的信心。這真的是基於您將克服社區推薦瓶頸的信心嗎？它是否實際上擴大了能夠進行治療的站點數量？如果您可以提供更多顏色，那將會非常有幫助。

Yeah. Thank you, Emmanuel. My apologies. It is still $5 billion plus. I misspoke.

是的。謝謝你，伊曼紐。我很抱歉。它仍達50多億美元。我說錯了。

So with respect to Pluvicto and the dynamics that we're seeing, I think within the academic centers and large integrated health centers that already are well set up, we expect to see a rapid uptake. I mean, these accounts, these are accounts that are familiar with the medicine. They have capacity. They do need to staff up, but we believe that's within their reach. And those are the accounts where we expect to see initial rapid uptake of the medicine. And that will drive, I think, the second half performance.

因此，就 Pluvicto 和我們所看到的動態而言，我認為在已經建立完善的學術中心和大型綜合醫療中心內，我們預計會看到快速的成長。我的意思是，這些帳戶，這些都是熟悉藥物的帳戶。他們有能力。他們確實需要增加員工，但我們相信這是他們所能做到的。我們期望這些帳戶能夠看到該藥物的初步快速吸收。我認為這將推動下半年的表現。

I think to reach the full potential within the PSMAfore population and the PSMA addition population, we're going to have to continue to expand not only the number of centers, but getting many of those centers to increase the volume of patients that they're seeing.

我認為，為了充分發揮 PSMA 前人群和 PSMA 附加人群的潛力，我們不僅要繼續擴大中心數量，還要讓其中許多中心增加其接診的患者數量。

So we would estimate of the centers that we've gotten set up, about half of those centers are using Pluvicto at a target rate in terms of the number of patients that are actually able -- they're actually processing through their clinic. And the remaining [300], we need to get up. We need to get up to a higher level of utilization, and then we also need to expand the number of sites. That's going to be some combination of getting comfort with use of the medicine.

因此，我們估計，在我們已經建立的中心中，大約有一半的中心正在以目標速率使用 Pluvicto，就實際能夠透過診所處理的患者數量而言。剩下的[300]人，我們需要起床。我們需要提高利用率，然後還需要擴大站點數。這將是使用藥物來獲得舒適感的某種組合。

Hence, we roll out the prefilled syringe, use with the referral networks and adequate capacity as well for the imaging, which we're working through as well. We've reorganized our field force to enable easier referrals, but also to hopefully better align with where imaging capacity is.

因此，我們推出了預充式註射器，與轉診網路一起使用，並有足夠的容量用於成像，我們也正在努力實現這一點。我們已經重組了我們的現場隊伍，以便更容易進行轉診，同時也希望更好地與成像能力的現狀保持一致。

And I think that will be really important as well. And then, of course, continuing to promote the medicine to patients and physicians so they understand the strong data set that we have. I mentioned the unadjusted OS and the adjusted OS, both of which I think have given confidence to experts that the medicine has the opportunity to have a significant impact on these patients. So each one of those activities is ongoing.

我認為這也非常重要。然後，當然，我們會繼續向患者和醫生推廣這種藥物，以便他們了解我們擁有的強大數據集。我提到了未調整的 OS 和調整後的 OS，我認為這兩者都讓專家相信這種藥物有機會對這些患者產生重大影響。因此，每一項活動都是持續進行的。

I think this is important for us, not only obviously because of Pluvicto, but also given the broader radioligand therapy portfolio that we're developing. We're now entering the clinic with multiple RLPs in rapid succession targets such as FAP, fiberglass activation protein, targets like HER2, B7-H3, DLL3, all of these targets now entering the clinic. And for that -- those medicines to be successful, we know we need to build out this community capacity and, hence, a big focus for the company to figure this out.

我認為這對我們很重要，顯然不僅是因為 Pluvicto，還因為我們正在開發的更廣泛的放射性配體治療組合。我們現在正進入臨床研究，快速連續地針對多個 RLP 靶點，例如 FAP、玻璃纖維活化蛋白、HER2、B7-H3、DLL3 等靶點，所有這些標靶現在都已進入臨床研究。為了使這些藥物成功，我們知道我們需要增強社區能力，因此公司要專注於解決這個問題。

Florent Cespedes, Bernstein.

弗洛朗·塞斯佩德斯、伯恩斯坦。

Just a quick follow-up on Pluvicto. In the US, when you said that 50% of the sellers are not Pluvicto at a target rate, is it -- what's the main pushback from the sellers? Is just they need more convenience, so prefilled prefer syringe would help? Or other -- any color on this front would be helpful.

這只是對 Pluvicto 的一個快速跟進。在美國，當您說 50% 的賣家沒有按照目標價格購買 Pluvicto 時，賣家的主要阻力是什麼？他們只是需要更多的便利，所以預先填充的注射器會有幫助嗎？或其他——這方面的任何顏色都會有幫助。

Yes. I think it's a combination of things, Florent. I think one is, of course, once you have a patient treated, to ensure you have adequate reimbursement and then see the process ultimately work. I think second, continuing to educate on the staffing needs and to be ahead of the curve in order to get patients treated. And then I think the referral networks and making sure the referral networks are operative so that patients are referred to locations where Pluvicto is available.

是的。我認為這是多種因素共同作用的結果，弗洛朗。我認為，當然，一旦患者得到治療，就要確保獲得足夠的報銷，然後觀察治療過程最終是否有效。我認為其次，要繼續對人員配備需求進行教育，並保持領先地位，以便讓患者得到治療。然後我認為轉診網路並確保轉診網路正常運行，以便將患者轉診到可以使用 Pluvicto 的地方。

I think these are all surmountable challenges. I think we've already made tremendous progress each 6-month period in terms of expanding the reach of the medicine. I remember a few quarters ago, we were at 100 or 150 centers now providing the medicine, and now we're at multiples higher than that. So I think we're getting there step by step. But of course, for each account, it is a puzzle that we need to solve. We've mapped that out geographically. We were reordering our field force to map to that mapping, and then we just have to, I think, stay consistent.

我認為這些都是可以克服的挑戰。我認為我們在擴大藥物覆蓋範圍方面每 6 個月已經取得了巨大進展。我記得幾個季度前，我們有 100 或 150 個中心提供這種藥物，而現在我們的數量已經超過了這個數字。所以我認為我們正在一步步實現這一目標。但當然，對於每個帳戶來說，這都是我們需要解決的難題。我們已經將其地理繪製出來了。我們正在重新安排我們的現場部隊以映射到該映射，然後我認為我們必須保持一致。

And when I look at corollary, you think about how long it's a chemotherapy and long ago to ultimately roll out. We know these things take time. But once you establish them into the standard of care, they stick. And that's the mindset we're taking, consistent investment over time to make it stick given the portfolio that we have that we're bringing forward.

當我看到推論時，你會想到化療需要多長時間以及多久才能最終推出。我們知道這些事情需要時間。但一旦你將它們納入護理標準，它們就會堅持下去。這就是我們所採取的思維方式，隨著時間的推移，我們會持續進行投資，以確保我們現有的投資組合能夠持續下去。

Peter Verdult, BNP Paribas Exane.

Peter Verdult，法國巴黎銀行 Exane。

Just one question for you, as on ianalumab in Sjögren's. I mean, the feedback from the docs is positive, but we know that there are no systemic treatment options to offer patients. It just seems from the people that we're getting -- that replicating that Phase II data you presented earlier, it will be enough to get the community excited.

我只想問您一個問題，關於乾燥症患者使用 ianalumab 的情況。我的意思是，醫生的回饋是正面的，但我們知道沒有系統的治療方案可以為患者提供。從我們得到的資訊來看——複製您之前提供的第二階段數據就足以讓社區興奮。

So I just wanted to check in on your latest thoughts ahead of that readout and how you're seeing the commercial opportunity if we were to compare it to something like Cosentyx and HS. Do you see Sjögren's being that sort of similar size or even bigger?

因此，我只是想在讀完這份報告之前了解您的最新想法，以及如果我們將其與 Cosentyx 和 HS 之類的產品進行比較，您如何看待其商業機會。您認為乾燥症的規模與此類似還是更大？

Yes, I think we see iana being a very significant medicine if successful, I think clearly with Sjögren's is having no approved systemic therapies and given the size of the patient population, there's an opportunity here to create a significant medicine. We haven't guided to specific numbers yet. But I think, certainly, a multibillion-dollar potential medicine is what we would expect in just the Sjögren's indication.

是的，我認為如果成功的話，iana 將成為一種非常重要的藥物，我認為乾燥症目前還沒有得到批准的全身療法，考慮到患者群體的規模，這是一個創造重要藥物的機會。我們還沒有給出具體的數字。但我認為，我們肯定會期望一種僅針對乾燥症的治療藥物能帶來數十億美元的潛在價值。

Now I think -- but that, I think, goes without saying that this will be a challenge with respect to, one, when you look at this disease, it's a heterogeneous disease. Hence, the endpoint here, the SI endpoint is a challenging endpoint.

現在我認為——但我認為，不言而喻，這將是一個挑戰，首先，當你觀察這種疾病時，你會發現它是一種異質性疾病。因此，這裡的終點，SI終點是一個具有挑戰性的終點。

We've done everything we can in the design of the study to ensure that we control for placebo effects, that we power appropriately, we have the appropriate statistical analysis, hierarchy, that we've included FDA requested patient-reported outcomes, which I think will also be important for physicians. We've done all of the steps needed to really give ourselves the best chance.

我們在研究設計中盡了一切努力，確保控制安慰劑效應，確保我們有適當的功效，有適當的統計分析和層次結構，並確保納入 FDA 要求的患者報告結果，我認為這對醫生來說也很重要。我們已經採取了所有必要的措施，真正為自己創造最好的機會。

And I think also it's going to be important to have impact not only on composite endpoints like [SI], but also very specific areas that patients care about: saliva production, fatigue, et cetera. So I think each one of these elements of the story have to ultimately tie together.

我認為這不僅會對像 [SI] 這樣的複合終點產生影響，而且對患者關心的具體領域也會產生影響，例如唾液分泌、疲勞等等。所以我認為故事中的每個元素最終都必須連結在一起。

And then I think the opportunity then is significant given that we're targeting patients here with systemic manifestations of the disease, so patients that clearly are having this impact their daily lives. And if we can demonstrate that we move the needle for patient quality of life, we would expect a very significant medicine. So we're excited about the readout. Hopefully, we can replicate what we saw in Phase IIb. But we're fully also acknowledged that this is a high-risk study that we have to deliver on.

我認為，鑑於我們針對的是患有系統性疾病的患者，因此這些患者的日常生活顯然受到了影響，因此這個機會意義重大。如果我們能夠證明我們能夠改善患者的生活質量，那麼我們就會期待一種非常重要的藥物。因此，我們對讀數感到很興奮。希望我們能夠複製我們在 IIb 階段所看到的結果。但我們也充分認識到這是一項必須完成的高風險研究。

Richard Vosser, JPMorgan.

摩根大通的理查‧沃瑟。

A question on Scemblix, please. The growth on prescriptions is very stunning but revenue growth is a bit below that. So just wondering whether you're having to rebate more heavily to generate first-line volume or we could see an uptick later on this year in terms of Scemblix more towards the prescriptions.

請問一個關於 Scemblix 的問題。處方藥的成長非常驚人，但收入的成長卻略低於這個水準。所以我只是想知道您是否需要加大回扣來產生一線銷量，或者我們可能會在今年稍後看到 Scemblix 在處方方面的銷量出現上升。

Yes. We've looked into this a bit. And I think one of the things we're seeing is when we look at the IQVIA data set versus what our internal data sets would show, our internal data sets, which are 73% TRx growth of Scemblix versus prior year, and that ties to the 75% net sales growth, so very much in line. We know IQVIA is showing a higher number. We think this might have to do with the nature of a rare disease product that's not flowing fully through only the pharmacy but also through a specialty distribution change.

是的。我們對此進行了一些調查。我認為，我們看到的一件事是，當我們將 IQVIA 數據集與我們的內部數據集顯示的結果進行比較時，我們的內部數據集顯示，Scemblix 的 TRx 與上年相比增長了 73%，這與 75% 的淨銷售額增長相關，因此非常一致。我們知道 IQVIA 顯示的數字較高。我們認為這可能與罕見疾病產品的性質有關，該產品不僅透過藥房流通，還透過專業分銷的變化流通。

So I think that's the key difference. It has more to do with channels than anything underlying the performance. I think most important for us is that we're seeing strong growth in the second-line and first-line indications. We have the reimbursement in place. We have the NCCN guidelines.

所以我認為這就是關鍵的區別。它與管道的關係比與表演相關的任何事情都更密切。我認為對我們來說最重要的是我們看到二線和一線適應症的強勁增長。我們已經辦理了報銷手續。我們有 NCCN 指南。

And now we think the growth should accelerate in the first and second line. And we think this medicine, as you know, has a very significant potential that we plan to fully realize.

現在我們認為一線和二線的成長應該會加速。我們認為，正如您所知，這種藥物具有非常大的潛力，我們計劃充分發揮它的作用。

James Quigley, Goldman Sachs.

高盛的詹姆斯·奎格利。

I have a question on pelacarsen's competitiveness. So last month, really put out Phase II data demonstrating a 94% reduction in the Lp(a) at the highest dose with a 180-day administration interval. The Phase III will clearly come after HORIZON, and we need to see that to really sort of see where the competitive landscape will move.

我對 pelacarsen 的競爭力有疑問。因此上個月，真正發布了 II 期數據，證明在 180 天的給藥間隔內，最高劑量的 Lp(a) 減少了 94%。第三階段顯然會在 HORIZON 之後進行，我們需要觀察這一點才能真正了解競爭格局將如何發展。

But with data emerging for competitors with longer dosing intervals, how does this impact your view on the competitiveness and/or your launch strategy for pelacarsen, assuming positive HORIZON data? And does this also increase the need to accelerate development of your own six-monthly or longer acting LP(a) option?

但是，隨著競爭對手的給藥間隔更長的數據不斷湧現，假設 HORIZON 數據為正，這會如何影響您對競爭力的看法和/或 pelacarsen 的發布策略？這是否也增加了加速開發您自己的六個月或更長時間有效的 LP(a) 選項的需要？

Yeah. Thanks, James. Certainly, we're watching the competitive landscape. But our core focus right now is to deliver on the Phase III trial and then accelerate towards the launch and hopefully establish ourselves as a first-in-class therapy and building the -- on our global cardiovascular presence with the monthly dosing, really get a broad base of patients on therapy.

是的。謝謝，詹姆斯。當然，我們正在關注競爭格局。但我們目前的核心重點是完成 III 期試驗，然後加速上市，並希望將我們自己確立為一流的治療方法，並透過每月給藥的方式建立我們在全球心血管領域的影響力，真正讓廣泛的患者接受治療。

I mean, we acknowledge the fact there could be competitors coming down the line with quarterly dosing and we'll see what the clinical data ultimately shows for that medicine, and then 6 monthly dosing, as you mentioned, later in the decade.

我的意思是，我們承認可能會有競爭對手採用每季一次的劑量給藥，我們會看看臨床數據最終會顯示什麼，然後像您提到的那樣，在未來十年內採用每 6 個月一次的劑量給藥。

But we feel confident that pelacarsen can have a very significant outlook with its current profile. I would note as well when we look at the recently published study that we -- that the investigators published on the baseline characteristics of the HORIZON study, you see a situation where the median level of Lp(a) was around 108. We had 80% of patients above 90%.

但我們相信，憑藉其目前的情況，pelacarsen 的前景將十分光明。我還想指出，當我們查看最近發表的研究時——研究人員發表了關於 HORIZON 研究基線特徵的研究，你會看到 Lp(a) 的中位數水平約為 108。我們有 80% 的患者達到了 90% 以上。

So I think that shows that we've enrolled a high-risk patient population in the study, which hopefully gives confidence that if the modeled performance of the drug ultimately -- and the modeled impact of Lp(a) reductions ultimately bears out, that we have a good chance to win on the study when it fully reads out.

所以我認為這表明我們在研究中招募了一群高風險患者，希望這能給人信心，如果藥物的模擬性能最終——以及 Lp（a）減少的模擬影響最終得到證實，那麼當研究全面結束時，我們就有很大機會獲勝。

I would say as well, we do have multiple efforts ongoing to get to less frequently dosed siRNAs or ASOs. Those could be as far out as -- out to one year is certainly the goal. We're trying to get to annual dosing. So we have the opportunity to establish ourselves in the market with a month, monthly dose therapy and then life cycle managed into a much less frequently dosed medicine that we'll be looking to hopefully bring to market at the end of the decade or the early part of the 2030s.

我也想說，我們確實正在不斷努力尋找劑量較低的 siRNA 或 ASO。這些可能要等到很遠——目標肯定是一年。我們正在嘗試實現年度劑量給藥。因此，我們有機會透過每月劑量療法在市場上站穩腳跟，然後進行生命週期管理，使其成為一種服用頻率更低的藥物，我們希望在本世紀末或本世紀30年代初將其推向市場。

Thibault Boutherin, Morgan Stanley.

摩根士丹利的 Thibault Boutherin。

I just have a question on the new Phase III study. You started with Kesimpta in you're dosing regimen. Is it extending injection interval? Is it exploring higher dose for more efficacy? Because it's quite late in the life cycle of the drug. So I'm just trying to understand the goal here. And could it be something potentially helping with IP duration, for example.

我只是對新的第三階段研究有個疑問。您開始使用 Kesimpta 作為您的給藥方案。是不是延長注射間隔？它是否在探索提高劑量以獲得更好的療效？因為這處於藥物生命週期的相當晚期階段。所以我只是想了解這裡的目標。例如，它是否可能有助於延長 IP 持續時間。

Yes. Thanks, Thibault. We -- this is an effort for us to increasing the dosing interval of Kesimpta before the end of the life cycle of the medicine. I think when we look now at the competitiveness of Kesimpta, given the situation with competitors not fully achieving their goals, I think we have an opportunity to continue to extend this franchise longer. So we're looking at infrequent dosing.

是的。謝謝，蒂博。我們——這是我們在藥物生命週期結束之前延長 Kesimpta 給藥間隔的努力。我認為，當我們現在審視 Kesimpta 的競爭力時，考慮到競爭對手未能完全實現其目標的情況，我認為我們有機會繼續延長這個特許經營權。因此，我們正在研究不頻繁的給藥。

We also have other internal efforts ongoing because we believe that Kesimpta can be a mainstay of B-cell therapy for an extended period of time, given that it's convenient at-home dosing which is, I think, convenient for patients around the globe.

我們也正在進行其他內部努力，因為我們相信 Kesimpta 可以長期成為 B 細胞療法的主要支柱，因為它可以方便地在家中服用，我認為這對全球患者來說都很方便。

We continue to pursue a BTK inhibitor, remibrutinib as well in MS. But we of course are cognizant of the fact that we do have four studies that have not shown an impact on RMS today from competitor products. So we would characterize that as still a high-risk opportunity. But given the overall competitive landscape, we want to ensure now that we fully life cycle Kesimpta.

我們將繼續研究 BTK 抑制劑瑞布替尼 (remibrutinib) 在 MS 的應用。但我們當然意識到，我們確實有四項研究並未顯示競爭對手的產品對 RMS 產生影響。因此我們認為這仍然是一個高風險的機會。但考慮到整體競爭格局，我們現在要確保 Kesimpta 的生命週期完全正常。

We currently don't believe we would face biosimilars in the United States until the early part of the 2030s. So we believe there's time to develop these alternative formulations.

我們目前認為，直到 2030 年代初美國才會面臨生物相似藥的出現。因此我們相信還有時間來開發這些替代配方。

Matthew Weston, UBS.

瑞銀的馬修·韋斯頓。

It's a question for Harry, please. Harry, in the 4Q slide deck earlier this year, there was a very prominent slide on the first half, second half dynamics in the year especially around profitability. It's absent in today's slides. Is that because you're expecting less of a sharp contrast in first half, second half now you've seen the launch of Kisqali and continued growth of Kesimpta? Or is it just that you decided not to include it today?

請問一下，這是問哈利的一個問題。哈利，在今年早些時候的第四季度幻燈片中，有一張非常突出的幻燈片展示了今年上半年和下半年的動態，尤其是盈利能力方面。今天的幻燈片中沒有這個內容。這是因為您預計上半年和下半年的對比不會那麼強烈，因為您已經看到了 Kisqali 的推出和 Kesimpta 的持續成長？或者您只是決定今天不將其包括在內？

We just wanted to see if you noticed. No, kidding. But no, thank you, Matthew. So obviously, the onetime effect of the gross to net for prior period, that is reflected in the current quarter. And then there are a couple of other effects that give us further confidence and contribute to the overall full year upgrade, right?

我們只是想看看您是否注意到了。不，開玩笑的。但不用了，謝謝你，馬修。顯然，上一期總額對淨額的一次性影響反映在本季。然後還有一些其他的影響可以增強我們的信心並有助於全年整體的提升，對嗎？

And one is that with this, there should be also better gross to net going forward. We adjusted our assumptions. We always learn every quarter. Of course, we are fully modeled in and accrued for the Medicare Part D redesign, which you already see part of Q1.

一方面，有了這個，未來的毛利率和淨利率應該會更高。我們調整了我們的假設。我們每季都會學習。當然，我們已經完全融入並累積了 Medicare Part D 重新設計的模型，您已經看到了 Q1 的一部分。

And the second -- the other contributor is, of course, very good growth performance overall. So clearly -- and therefore, I see both half one being better than what the outlook; but also half two, half two, I mentioned low to mid-single digit. We now would see the half two to be in the mid-single-digit range given these two improvements of more favorable gross to net ongoing as well as better-than-expected performance on some brands. So I hope that answers your question. But we can happily add that slide back if it's very helpful.

第二，另一個因素當然是整體非常好的成長表現。所以很明顯——因此，我認為一半比一半的前景要好；但也有一半二，一半二，我提到了低到中等個位數。鑑於持續的毛利潤與淨利潤更加有利以及某些品牌的業績好於預期，我們現在預計下半年的業績將處於中等個位數範圍內。我希望這能回答你的問題。但如果它非常有用，我們很樂意將其添加回來。

And then we continue to see here if our mid-year assumption for [a three] to be genericized brands in the US as a financial planning assumption plays out or if we would have updates for you. But of course, at the moment we would know, we will inform you. Therefore, for the time being, we recommend that continues to be the financial planning assumption for everybody.

然後，我們繼續觀察，我們關於在美國推出 [三個] 通用品牌的年中假設是否能夠實現，作為財務規劃假設，或者我們是否會為您提供更新資訊。但當然，一旦我們知道，我們就會通知您。因此，就目前而言，我們建議這繼續作為每個人的財務規劃假設。

Kerry Holford, Berenberg.

凱莉·霍爾福德，貝倫貝格。

On [Votubia], please. Are using on track to release that Phase II data in the first half of this year? And do you see the potential to file and securing approval in Huntington on that data alone? Or should we assume a Phase II study is likely to be required?

請在[Votubia]上。是否會在今年上半年發布第二階段的數據？您是否認為僅憑這些數據就有可能在亨廷頓提交申請並獲得批准？或者我們是否應該假設可能需要進行第二階段的研究？

Yes. Thanks, Kerry. As you know, Votubia is currently being -- the Phase II study is being conducted by a PTC. So we do expect the readout in the first half of this year. And I think when we see the data, we'll have a better sense of -- if on top of mutant Huntington protein reduction, we also see improvements in clinical endpoints, which would be, I think, needed for us to be able to file with FDA.

是的。謝謝，克里。如您所知，Votubia 目前正由 PTC 進行第二階段研究。因此我們確實預計今年上半年會公佈數據。我認為，當我們看到數據時，我們會有更好的認識——如果除了突變亨廷頓蛋白減少之外，我們還看到臨床終點的改善，我認為這是我們能夠向 FDA 提交申請所必需的。

So I think based on the data, we'll work with our partners at PTC to determine what's the right approach, whether to file off of that Phase B or to move forward to conduct a pivotal Phase III study. So stay tuned. I think we'll obviously know more once we have a look at the data. And of course, we're staying abreast of the evolving kind of mindset within FDA and certainly what other competitors are doing as well. So we'll see how the data unfolds.

因此，我認為，基於數據，我們將與 PTC 的合作夥伴一起確定正確的方法，是結束 B 階段研究還是繼續進行關鍵的 III 階段研究。敬請關注。我認為，一旦我們查看了數據，我們就會了解更多。當然，我們會密切關注 FDA 內部不斷變化的思維方式以及其他競爭對手的做法。因此我們將觀察數據如何展開。

Seamus Christopher Fernandez, Guggenheim.

古根漢美術館的謝默斯·克里斯托弗·費爾南德斯。

So really just wanted to ask about value-creating bolt-ons and areas of focus for BD, in particular, if you see opportunities for life cycle management via BD around your hypertension and heart failure portfolio particularly given the upcoming loss of Entresto in the US but the robust opportunity for Entresto in overseas markets.

所以實際上只是想問 BD 的價值創造附加功能和重點領域，特別是，如果您看到透過 BD 對您的高血壓和心臟衰竭產品組合進行生命週期管理的機會，特別是考慮到 Entresto 即將在美國失去市場，但 Entresto 在海外市場擁有強勁的機會。

Yeah. Thanks, Seamus. So nothing specific to say. I mean, we feel very good about our cardiovascular pipeline overall. We have, of course, Entresto, Leqvio, pelacarsen.

是的。謝謝，西莫斯。所以沒什麼特別要說的。我的意思是，我們對我們的心血管產品線整體感覺非常好。當然，我們有 Entresto、Leqvio 和 pelacarsen。

We have our entire renal portfolio. We recently did the Anthos acquisition to get abema, the monoclonal antibody for anti-coagulation into the portfolio. We have a broad range of siRNAs targeting cholesterol lowering, targeting Lp(a) lowering, targeting hypertension lowering in-house as well.

我們擁有完整的腎臟產品組合。我們最近收購了 Anthos，將抗凝血單株抗體 abema 納入產品組合。我們擁有一系列針對降低膽固醇、降低脂蛋白（a）以及降低高血壓的 siRNA。

So all those programs are proceeding -- and also an antiarrhythmic portfolio. So I think we, of course, are looking across the opportunities out from a bolt-on standpoint, but no particular focus on cardiovascular medicines at this time.

因此，所有這些項目都在進行中——還有抗心律不整藥物組合。因此，我認為我們當然是從附加的角度來尋找機會，但目前並沒有特別關注心血管藥物。

Steve Scala, TD Securities.

道明證券的史蒂夫‧斯卡拉 (Steve Scala)。

Novartis has among the fewest manufacturing plants in the US in the industry. but did announce the $23 billion program to expand the US footprint. The question is how much of that $23 billion buildout to the footprint will be complete in -- by 2028?

諾華公司在美國的製造工廠數量在業界名列前茅。但確實宣布了一項230億美元的計劃來擴大美國影響力。問題是，到 2028 年，這 230 億美元的建設工程有多少能夠完成？

It seems that such a profound pivot could be a less than ideal decision if the views in the US were different in four years. If instead, it was an inevitable pivot regardless of the US President, then why didn't it start sooner? And related to this, you said Novartis can manage plans put forward in the US so far. Does that include most favored nation legislation?

如果四年後美國的觀點發生變化，那麼如此深刻的轉變似乎不是一個理想的決定。如果無論美國總統是誰，這都是一個不可避免的轉變，那麼為什麼它沒有早點開始呢？與此相關，您說諾華可以管理迄今為止在美國提出的計劃。這是否包括最惠國立法？

Thanks, Steve. So on point one, I think we would acknowledge, I think, we could have done this earlier. I mean, this is a strategic decision to say that US is our most important single market from a growth and revenue standpoint. And we want to be in a position to be able to produce all of our key medicines end to end in the US.

謝謝，史蒂夫。因此，關於第一點，我想我們會承認，我認為我們本可以早點做到這一點。我的意思是，這是一個策略決策，從成長和收入的角度來看，美國是我們最重要的單一市場。我們希望能夠在美國實現所有主要藥品的端到端生產。

And so I think we -- you're right, we should have recognized it sooner. But now we have recognized and I think independent of who's president, it's prudent for us to be able to have our supply chain stable inside the United States.

所以我認為——你是對的，我們應該早點認識到這一點。但現在我們已經意識到，我認為無論誰擔任總統，我們明智的做法是能夠在美國境內保持供應鏈穩定。

We do have a number of medicines already fully produced in the US cell and gene, our Leqvio, Kesimpta, our gene therapy, Pluvicto. And then the other relevant therapies, we believe within this period of time, we can get the necessary manufacturing plants up and running given our footprint that we already have in certain locations to manage this. But it is a strategic decision independent of the President to make sure that we have that capacity inside the United States.

我們確實有許多藥物已經在美國細胞和基因中完全生產，我們的Leqvio、Kesimpta，我們的基因療法Pluvicto。至於其他相關療法，我們相信在這段時間內，我們可以建立並運作必要的製造工廠，因為我們在某些​​地方已經擁有管理這些療法的足跡。但這是一個獨立於總統的戰略決策，旨在確保我們在美國境內擁有這種能力。

Now in terms of most favored nation, of course, I think if this policy, which I think would be devastating to the industry was ultimately put forward in any kind of meaningful way. It would cause, I think, all companies to have to relook at their long-term -- medium to long-term outlook. It goes without saying.

現在就最惠國待遇而言，當然，我認為如果這項政策最終以任何有意義的方式提出，我認為這將對該行業造成毀滅性打擊。我認為，這將導致所有公司必須重新審視其長期、中期和長期前景。不言而喻。

But I think it's really important that we keep advocating that the United States should not import European price controls in the European anti-innovation or challenging innovation environment into the United States. I don't think that will serve patients well, serve health care systems will and the biotechnology ecosystem well. And that's certainly what we're advocating for.

但我認為，真正重要的是，我們要繼續倡導美國不應該將歐洲反創新或挑戰創新環境中的價格管制引入美國。我認為這對患者、醫療保健系統和生物技術生態系統都沒有好處。這當然也是我們所提倡的。

Rather, the focus should be to correct the imbalances that have occurred in Europe over the last decades and hopefully get a better environment in Europe that's more competitive with the United States.

相反，重點應該是糾正過去幾十年來歐洲出現的不平衡現象，並希望歐洲能獲得一個更好的環境，從而更具競爭力。

Graham Parry, Bank of America.

美國銀行的格雷厄姆·帕里。

So first one is just on Pluvicto and PSMA addition. Just wondered, when you get the PFS primary endpoint read, roughly what proportion of overall survival events you think you'd have and whether that will be sufficient for finding just given you needed more OS data on PSMAfore?

因此，第一個只是關於 Pluvicto 和 PSMA 的補充。只是想知道，當您讀取 PFS 主要終點時，您認為您將擁有的總體生存事件大致佔多大比例，以及這是否足以找到您需要有關 PSMAfore 的更多 OS 數據？

And then actually, I just wanted to follow up on Harry's comment on Entresto. I think -- because Vas, as I think you were quoted on the wires this morning saying expecting generic Entresto in July. Harry still refers to that as a modeling assumption. So could we still see some flex in that? Is there a potential for a 918-patent ruling or a settlement there that could see this bumped into 2026 in the scenarios that you see?

實際上，我只是想跟進 Harry 對 Entresto 的評論。我認為——因為 Vas，我認為你今天早上在電報上說過，預計 7 月會推出仿製版 Entresto。哈利仍然稱之為建模假設。那我們還能從中看到一些彈性嗎？在您看來，是否有可能透過 918 項專利裁決或和解，導致該案延至 2026 年？

Yes. Thanks, graham. So first on Pluvicto PSMA addition, so at the time of the RPFS output, difficult to say exactly, but we would expect OS in the range -- the OS events in the range of 40% to 60%, something in that range overall. And I think our view is that we would maintain the study blind, and then with a small group review the data set with FDA to ensure that the FDA felt like the OS is sufficient at that point in time, assuming the study is positive for us to take it forward.

是的。謝謝，格雷厄姆。因此，首先在 Pluvicto PSMA 上進行添加，因此在 RPFS 輸出時，很難確切地說，但我們預計 OS 的範圍 - OS 事件的範圍在 40％ 到 60％ 之間，總體上在這個範圍內。我認為我們的觀點是，我們將保持研究的盲性，然後由一個小組與 FDA 一起審查資料集，以確保 FDA 認為 OS 在當時是足夠的，假設這項研究對我們繼續推進是積極的。

And if they tell -- inform us it's not the case, then we'll maintain the study blind,so as not to inadvertently change the rate of crossover in the study. So that's the approach we're currently taking on PSMA addition.

如果他們告訴我們事實並非如此，那麼我們將保持研究的盲目性，以免無意中改變研究中的交叉率。這就是我們目前對 PSMA 添加採取的方法。

Now with respect to Entresto, there are multiple cases ongoing. So we have two generic filers that we've not settled with. We do have the ongoing patent litigation on the amorphous complex patent, which is pending. We have the ongoing trade [drug] litigation as well with MSN. We have the ongoing litigation with the FDA on whether the approvals are valid. So all of these litigations are ongoing. And at any point in time, any of those litigations could shift our perspective on the mid-2025 LOE.

目前，關於 Entresto，有多起案件正在審理中。因此，我們有兩個尚未解決的通用文件管理器。我們確實正在對非晶複合物專利進行訴訟，該訴訟目前尚未結束。我們與 MSN 之間還有正在進行的貿易（藥品）訴訟。我們正在與 FDA 就該批准是否有效進行訴訟。因此，所有這些訴訟仍在進行中。並且在任何時候，任何一場訴訟都可能改變我們對 2025 年中期 LOE 的看法。

But I think until we hear from any of those cases, the most prudent course for us is to maintain a mid-25LOE. And if it changes, of course, we'll immediately update the markets and then update our outlook accordingly.

但我認為，在我們聽到任何此類案例之前，對我們來說最謹慎的做法是維持 25LOE 中段。當然，如果情況發生變化，我們會立即向市場通報，並相應地更新我們的展望。

Okay. So just to replay, that's based on litigation outcome as a place to settlement that you're referring to potential for it to move.

好的。因此，再次重申一下，這是基於訴訟結果作為和解地點，您指的是其移動的可能性。

It could be litigation outcome or settlement. All of the above are things we're working on.

這可能是訴訟結果或和解。以上都是我們正在努力的事情。

James Quigley, Goldman Sachs.

高盛的詹姆斯·奎格利。

Just a quick follow-up for me. Given the European prices has been mentioned a couple of times. So how -- what is the politicians' view on this at the moment? Is it seen as a problem? Or do you have some support from some European politicians about addressing the innovation imbalance that you see between Europe and the US? And have any negotiations or discussions started? Or are we still in a standing start and, hence, the reason for your letter?

對我來說只是一個快速的跟進。鑑於歐洲的價格已被提及過幾次。那麼──目前政界人士對此有何看法？這被視為一個問題嗎？或者您得到了一些歐洲政界人士的支持，以解決您所看到的歐洲和美國之間的創新不平衡問題？有任何談判或討論已經開始嗎？或者我們仍處於起步階段，因此才寫這封信？

Yeah. Thanks, James. There is a letter from FT to the European Commission, which I think has been published publicly, which I think outlined some of the topics but not the specific recommendations that Paul and I put forward in the FT. But I think that was a response to a request from the European Commission to understand how the innovation environment in Europe can ensure that they retain their leading biotechnology sector, biotechnology manufacturing, biopharmaceutical R&D.

是的。謝謝，詹姆斯。英國《金融時報》給歐盟委員會寫了一封信，我認為這封信已經公開發表，我認為這封信概述了一些主題，但沒有概述保羅和我在《金融時報》上提出的具體建議。但我認為這是對歐盟委員會要求的回應，旨在了解歐洲的創新環境如何確保其保持領先的生物技術領域、生物技術製造和生物製藥研發。

I think a lot of the focus right now is in streamlining regulations, which are welcome; streamlining and improving regulatory data protection, also welcome; strengthening overall support for the biotech ecosystem, metro capital, et cetera, all welcome as well.

我認為目前的重點是簡化法規，這是值得歡迎的；簡化和改進監管資料保護，也受到歡迎；加強對生物技術生態系統、大都會資本等的整體支持，也都受到歡迎。

But I think we as an industry and at least some of other CEOs strongly believe that this also should be an opportunity to rethink the overall approach to valuing innovation in the European community. And I think that's what we're trying to focus on.

但我認為，我們作為一個行業以及至少一些其他執行長都堅信，這也應該是一個重新思考歐洲社會對創新的整體評價方法的機會。我認為這正是我們努力關注的重點。

I can't really comment on whether or not those -- that is being viewed as something that will be taken out by the commission. That's not something they've communicated back to us. But it's certainly something we're advocating for both at the commission level and with individual countries around Europe as well.

我無法真正評論這些是否被視為將被委員會取消的東西。他們並沒有向我們傳達這個訊息。但我們確實在委員會層級以及歐洲各國都提倡這一點。

Thibault Boutherin, Morgan Stanley.

摩根士丹利的 Thibault Boutherin。

Your press release mentioned a litigation with drug manufacturer for a generic of Lutathera. Just if you could help us understand what generic would look like with radioligand in terms of type of price discounts. Any challenges a potential generic maker could face in terms of penetration, supply challenges, these kind of things?

您的新聞稿中提到了與藥品製造商就 Lutathera 仿製藥進行的訴訟。如果您能幫助我們了解仿製藥與放射性配體在價格折扣類型方面的表現如何，那就太好了。潛在的仿製藥製造商在滲透、供應等方面會面臨哪些挑戰？

Yes. So first, I think on generics and RLT, this is not something where there is, we believe, an adequate or clear regulatory standard. So while one topic is -- any proposed generic infringe on our IP, which is what the litigation is referring to, separate from that we have filed citizens petitions and continue to advocate with the regulators around the world to clarify what is expected of a radioligand therapy, and it should absolutely be held to the standard of ensuring patients and the tumor is receiving an equivalent dose of radiation to ensure efficacy and appropriate safety. So that's all, I think, also ongoing.

是的。因此，首先，我認為對於仿製藥和受體激動劑 (RLT) 而言，我們認為不存在充分或明確的監管標準。因此，雖然一個主題是 - 任何擬議的對我們知識產權的通用侵犯，這就是訴訟所指的，但除此之外，我們還提交了公民請願書，並繼續向世界各地的監管機構倡導，以澄清對放射性配體療法的期望，並且絕對應該達到確保患者和腫瘤接受等效劑量輻射的標準，以確保療效和適當的安全性。所以我認為這一切都還在進行中。

And then the third question is the supply chain and can a potential generic manufacturer produce the medicine in a way that doesn't also infringe on our patents in terms of production and know-how in terms of production, but also in a way that reliably provides these medicines to patients given that you have a four-day -- three to five-day window, depending on the medicine, to actually get it to physicians.

第三個問題是供應鏈，潛在的仿製藥製造商能否以不侵犯我們生產專利和生產技術的方式生產藥品，同時又能以可靠地將這些藥品提供給患者的方式生產藥品，因為您有四天到三到五天的時間（取決於藥品）才能真正將藥品送到醫生手中。

And as we've learned, it's absolutely critical to be on time in full. And Novartis right now is 99.9% on time in full for our radioligand therapy business. And that's the standard I think physicians expect and that any generic company would also have to meet.

正如我們所了解的，按時完成任務絕對至關重要。目前，諾華的放射性配體治療業務按時完成了 99.9%。我認為這是醫生期望的標準，也是任何仿製藥公司也必須達到的標準。

So I think those are the three levels of the ongoing discussion. I think it will take years to resolve. But it will be important because these standards will ultimately be what defines the sector in the longer run.

所以我認為這就是正在進行的討論的三個層次。我認為這個問題需要幾年的時間才能解決。但這很重要，因為從長遠來看，這些標準最終將決定該行業的發展。

Matthew Weston, UBS.

瑞銀的馬修·韋斯頓。

I'd love to go back to Graham's question on tax, Harry. On the Astra call, Pascal was prepared to say that he believes Astra pays a fair amount of tax in the US relative to the sales booked in the US and the total tax paid by the company. There's been a lot of discussion in the past as to how Novartis pays tax in the US, some of it before your time. So I'd just be interested if you're comfortable saying the same thing from a Novartis perspective.

哈利，我很樂意回到格雷厄姆關於稅收的問題。在阿斯特拉電話會議上，帕斯卡準備說，他相信阿斯特拉在美國繳納的稅款相對於在美國取得的銷售額和公司繳納的總稅額來說是相當多的。關於諾華如何在美國納稅，過去有很多討論，其中一些討論是在你任職之前進行的。因此，如果您願意從諾華的角度說同樣的話，我會很感興趣。

Thank you, Matthew. Harry?

謝謝你，馬修。哈利？

Of course, we pay in every jurisdiction we do business our fair and proper amount of taxes. And by the way, we don't have any offshore balance sheet structure. So from that standpoint, we are very confident in our tax planning and very robust.

當然，我們在開展業務的每個司法管轄區都繳納了公平適當的稅款。順便說一句，我們沒有任何離岸資產負債表結構。因此從這個角度來看，我們對我們的稅務規劃非常有信心，而且非常穩健。

Graham Parry, Bank of America.

美國銀行的格雷厄姆·帕里。

Last one, I promise. So I just wanted to follow up, actually, guys, on the -- to qualify the comment you said about MFN being devastating for the industry, I think the word you used, if it was implemented. But when you say devastating, are you talking about MFN being imposed across both government and commercial setting? Or do you see that just in position across Medicare, Medicaid would actually have that level of impact. I think it's an important clarification.

最後一個，我保證。所以，夥計們，我只是想跟進一下——為了證明你們所說的最惠國待遇對行業具有毀滅性的影響，我認為你們使用的詞語是，如果它得到實施的話。但是當您說毀滅性的時候，您是指在政府和商業環境中實施最惠國待遇嗎？或者您是否認為僅在醫療保險和醫療補助計劃中實施就會產生這種程度的影響。我認為這是一個重要的澄清。

Yes, absolutely. Look, of course, of course, the devil's in the details with these things. I think MFN, as previously conceived, is limited to Part B drugs. For Novartis, highly manageable. If it's MFN in Medicare Part B and Part D but we no longer have to pay rebates and a number of other discounts disappear, manageable.

是的，絕對是。當然，當然，這些事情的細節決定了一切。我認為，最惠國待遇，按照以前的設想，僅限於 B 部分藥品。對於諾華來說，這是非常容易管理的。如果這是醫療保險 B 部分和 D 部分中最惠國待遇，但我們不再需要支付回扣，而且許多其他折扣也消失了，這是可以管理的。

If it's Medicare Part B, Part D with the spillover into Medicaid, the spillover into 340B pricing and all of the other problems, definitely painful. If it spills over into the private market, devastating. So I mean, I think all of this, of course, is something to look at.

如果是醫療保險 B 部分、D 部分，並且溢出到醫療補助、溢出到 340B 定價和所有其他問題，那肯定是痛苦的。如果它蔓延到私人市場，後果將是毀滅性的。所以我的意思是，我認為所有這些都是值得關注的。

And here, I speak about the industry, I think, broadly as well. I mean, of course, for Novartis, given our relative exposure to the US and relative exposure to Medicare, if this policy ultimately were to come into place, we're well positioned relatively speaking. But that still doesn't mean that we would, in any way, want this to happen given -- obviously, given the damage it would do to our ability to invest in R&D, invest in manufacturing, invest in future pipeline of medicines for patients around the globe. it would definitely have a significant impact.

在這裡，我想談論的也是這個行業的廣泛性。我的意思是，當然，對於諾華來說，考慮到我們對美國的相對敞口以及對醫療保險的相對敞口，如果這項政策最終得以實施，那麼我們相對而言處於有利地位。但這仍然不意味著我們希望這種情況發生——顯然，這會損害我們投資研發、投資製造、投資未來為全球患者提供藥物的能力。這肯定會產生重大影響。

But certainly, it depends on the details of what ultimately is conceived.

但當然，這取決於最終構思的細節。

Florent Cespedes, Bernstein.

弗洛朗·塞斯佩德斯、伯恩斯坦。

First, a big picture question on IRA. Could we have your thoughts about the difference in exclusivity between small molecule and large molecules in 9 years versus 13 years? Do you see any, let's say, possible happy endings or more favorable trend on this front? Any color will be great.

首先，關於 IRA 的一個宏觀問題。您能否談談小分子和大分子在 9 年和 13 年的獨佔期之間的差異？您是否看到了這方面的任何可能圓滿結局或更有利的趨勢？任何顏色都很好。

I think it's very promising and I think a good sign that in the President's executive order that there was support for moving as a small molecule 9 years to 13 years and something the industry has made our top priority from a legislative standpoint. We have the pay [force] to enable this to happen. So it's our absolute focus that any reconciliation bill is taken forward, that the correction of 9 and 13 is part of that reconciliation bill. And I think we have a good bipartisan support both in the House and Senate to make that happen.

我認為這是非常有前景的，而且我認為總統的行政命令支持將小分子的註冊期限從 9 年延長至 13 年，這是一個好兆頭，從立法角度來看，業界已將此作為首要任務。我們有足夠的力量來實現這一點。因此，我們絕對關注的是任何和解法案的推進，第 9 條和第 13 條的修正是和解法案的一部分。我認為，眾議院和參議院都給予了我們良好的兩黨支持，可以實現這一目標。

And I think we know that with respect to these kinds of bills, it really comes down to the very final language on the last day. So we can never be sure. But I think all signs are positive that we have an opportunity to get this fixed, which would really, I think, enable us to sustain small molecule drug innovation into the future. So I'm hopeful at this point that we could make something happen.

我認為我們知道，對於這類法案，最終結果取決於最後一天的最終措辭。所以我們永遠無法確定。但我認為所有跡像都是正面的，表明我們有機會解決這個問題，我認為這將真正使我們能夠在未來維持小分子藥物創新。因此，我現在充滿希望，希望我們能取得一些成果。

I think while on that, I think we continue to also advocate, of course, on PBM reform. I think there was a good bill that nearly passed in December, and we continue to hope that can happen. And then we continue to advocate for the fixing the 340B system as well. That may not happen legislatively, but we continue to pursue all avenues to ensure that there's no abuse of the 340B system. There was an important report put out by the Senate Health Committee, I think, that highlights the problems in the current system.

我認為，在此基礎上，我們當然也會繼續倡議 PBM 改革。我認為 12 月有一項很好的法案幾乎獲得通過，我們仍然希望它能夠實現。然後我們繼續倡導修復 340B 系統。這可能不會在立法上實現，但我們會繼續尋求一切途徑確保 340B 系統不會被濫用。我認為參議院衛生委員會發布了一份重要報告，強調了現行體系中存在的問題。

So hopefully, step by step, we get to a place where that program is also put into its proper context of actually helping patients and clinics in low-income communities and disadvantaged rural communities get the support they need without the abuse that we're seeing around the country.

因此，我們希望一步步地將該計劃納入適當的環境，真正幫助低收入社區和貧困農村社區的患者和診所獲得他們所需的支持，而不會出現我們在全國各地看到的虐待行為。

So those would be the three, I think, big legislative priorities for the industry and for Novartis.

因此，我認為，這些將是該行業和諾華的三大立法重點。

(Operator Instructions)

（操作員指示）

No? All right. Very good. Thank you all very much. Thank you for joining today's call. We look forward to keeping you up to speed on all happenings at Novartis, and we wish you a great day.

不？好的。非常好。非常感謝大家。感謝您參加今天的電話會議。我們期待讓您了解諾華公司的所有動態，並祝您度過美好的一天。

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

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。