Novartis AG (NVS) 2024 Q4 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q4 2024 results release conference call and live webcast.

早上好，下午好，歡迎參加諾華 2024 年第四季業績發布電話會議和現場網路直播。

(Operator Instructions) The conference is being recorded.

（操作員指示）會議正在錄音。

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

（操作員指示）電話會議結束後不久，電話會議的錄音（包括問答環節）將在我們的網站上提供。

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

現在，我想將麥克風交給投資人關係主管史隆辛普森女士。

Please go ahead, madam.

女士，請繼續。

Thank you, Sharon.

謝謝你，莎倫。

Good morning and good afternoon, everyone, and welcome to our Q4 and full year 2024 earnings call.

大家早上好，下午好，歡迎參加我們的 2024 年第四季和全年財報電話會議。

The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors.

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。

These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements.

這些可能會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.

有關這些因素的一些描述，請參閱該公司分別向美國證券交易委員會提交的 20-F 表和最新的 6-K 表季度業績。

Before we get started, I just want to echo Sharon's comment for all of 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，我只想重複 Sharon 對我們所有分析師的評論，請將自己限制一次只問一個問題，我們會盡可能地循環瀏覽隊列。

And with that, I will hand across to Vas.

說完這些，我將把麥克風交給 Vas。

Terrific.

了不起。

Thanks, Sloan, and thanks, everybody, for joining today's call to review our quarter four 2024 and full year results.

謝謝斯隆，也謝謝大家參加今天的電話會議來回顧我們 2024 年第四季和全年業績。

So moving to slide 4.

現在轉到投影片 4。

As you saw this morning, Novartis delivered one of the strongest performances that we've had in our history in 2024.

正如大家今天早上所看到的，諾華在 2024 年取得了我們歷史上最強勁的業績之一。

When you look at quarter four, our sales grew 16% and core operating income grew 29% in constant currency.

從第四季來看，我們的銷售額成長了 16%，核心營業收入以固定匯率計算成長了 29%。

And on the full year, we had 12% sales growth and 22% core operating income growth with our margin reaching 38.7%, well on our way to our goal of 40% plus margin.

全年來看，我們的銷售額成長了 12%，核心營業收入成長了 22%，利潤率達到了 38.7%，距離我們 40% 以上的利潤率目標還很遠。

We also had important pipeline highlights in the quarter, including Scemblix and Kisqali, which we'll go through in more detail later on in the call.

本季我們也有重要的產品線亮點，包括 Scemblix 和 Kisqali，我們將在稍後的電話會議中詳細介紹。

Overall, we met and exceeded our full year guidance in 2024, and we're continued -- confident in continued growth in sales in core op inc in 2025, as Harry will outline later in the call.

總體而言，我們在 2024 年達到並超越了全年預期，我們對 2025 年核心營運業務的銷售額將繼續成長充滿信心，正如 Harry 稍後在電話會議中概述的那樣。

So moving to slide 5.

現在轉到投影片 5。

Our priority brands continued to drive robust growth in the quarter.

我們的重點品牌在本季持續實現強勁成長。

And I think importantly, that demonstrates we have the replacement power to consistently grow through the end of the decade.

我認為重要的是，這表明我們擁有替代能力，能夠在本世紀末持續成長。

Overall, this portfolio of brands grew 38% in constant currencies and excluding Entresto, grew 41%.

總體而言，以固定匯率計算，該品牌組合成長了 38%，不包括 Entresto，則成長了 41%。

So we feel very good about the momentum we have.

因此，我們對目前的發展動能感到非常滿意。

And this is what gives us confidence in the 5% plus sales guidance out to 2029 and the mid-single-digit growth we believe we can deliver in the long term.

這使我們對 2029 年 5% 以上的銷售預期以及長期內能夠實現的中位數個位數成長充滿信心。

Now, moving to slide 6.

現在轉到投影片 6。

Entresto achieved sales of $7.8 billion on the full year.

Entresto 全年實現銷售額 78 億美元。

That's up 31%.

增長了 31%。

And when you look at the left side, you can see we had very good growth, both in the United States and in our international markets.

當您查看左側時，您會發現我們在美國和國際市場都實現了非常好的成長。

The total prescriptions for Entresto in the weekly TRx in the US continued to climb.

美國每週 TRx 中 Entresto 的總處方量持續攀升。

We had plus 41% growth in the United States with 9,000 NBRxs per week.

我們在美國實現了 41% 的成長率，每周有 9,000 次 NBRxs。

Ex-US continued to perform well.

美國以外地區持續表現良好。

And I think importantly, we see very good performance in heart failure as well as hypertension in China and Japan.

我認為重要的是，我們看到中國和日本在心臟衰竭和高血壓方面表現得非常好。

Now, when we look at the outlook for Entresto, we've updated the market that for forecasting purposes, we assume Entresto LOE in mid-2025.

現在，當我們展望 Entresto 的前景時，我們更新了市場，出於預測目的，我們假設 Entresto 的 LOE 將在 2025 年中期實現。

As you likely have seen, our combination pattern is upheld and we currently believe we will be able to secure pediatric exclusivity, though we'll continue to monitor the situation closely, and that enables us to guide to a mid-2025 LOE.

正如您可能已經看到的，我們的組合模式得到維持，我們目前相信我們將能夠確保兒科特許經營權，儘管我們將繼續密切監視情況，這使我們能夠指導 2025 年中期的 LOE。

Outside of the US, our RDP protection lasts until November 2026 with a protection in Japan until 2030, and we continue to pursue additional options for further protection in these markets.

在美國以外，我們的 RDP 保護將持續到 2026 年 11 月，在日本的保護將持續到 2030 年，我們將繼續在這些市場尋求更多選擇以提供進一步的保護。

I think when you think about forecasting Entresto for the rest of the decade, it's important to note that the US sales are about 50% of the global sales.

我認為，當您考慮預測 Entresto 在未來十年的銷售量時，重要的是要注意美國的銷售量約佔全球銷售量的 50%。

But importantly, Europe contributes 20% and China and Japan in total of 15% of this brand.

但重要的是，歐洲貢獻了該品牌的20%，中國和日本共佔15%。

So moving to slide 7.

請轉到投影片 7。

Cosentyx topped $6 billion of sales in the full year, growing 25%.

Cosentyx 全年銷售額突破 60 億美元，成長 25%。

This was fueled by our new launches in HS as well as the IV launch.

這是由我們在 HS 和 IV 中推出的新產品所推動的。

When you look at the fourth quarter, we had US sales up 36%, as mentioned by the key launches.

從第四季來看，正如主要產品發布會所提到的，我們的美國銷售額成長了 36%。

Outside of the United States, we had 7% constant currency growth driven mainly by volume in our core indications.

在美國以外，我們實現了 7% 的固定匯率成長率，這主要得益於我們核心指標的交易量。

Now, when you look at how things are unfolding for the brand, we remain number one -- the number one IL-17 in the US dynamic market, and we remain the leading originator biologic in both the EU and China.

現在，當你觀察品牌的發展時，你會發現我們仍然是美國動態市場上排名第一的 IL-17，並且仍然是歐盟和中國領先的原始生物製劑。

Now, looking ahead, we plan to accelerate growth through the HS launch with the NBRx leadership.

現在，展望未來，我們計劃在 NBRx 領導下透過 HS 的推出來加速成長。

We've already established with 60% NBRx share and continuing to secure reimbursement in our key markets.

我們已經建立了 60% 的 NBRx 份額，並繼續在我們的主要市場獲得報銷。

Now, IV has started to see accelerated adoption in the US.

現在，IV 在美國開始得到加速應用。

We have about 1,625 accounts ordering.

我們有大約 1,625 個訂購帳戶。

We saw 22% quarter-on-quarter growth, but it's still early days, and we're working through now really accelerating the IV adoption.

我們看到了 22% 的季度環比增長，但現在還為時過早，我們現在正在努力加速 IV 的採用。

And over the course of the year, we expect two Phase 3 readouts in giant cell arteritis and polymyalgia rheumatica which, if positive, would provide further engines for growth for Cosentyx through the remainder of the decade.

我們預計，今年內，鉅細胞動脈炎和風濕性多肌痛的兩項 3 期臨床試驗將取得積極結果，這將為 Cosentyx 在本世紀剩餘時間內的增長提供進一步的動力。

Now, moving to slide 8.

現在轉到投影片 8。

Kesimpta grew 49%, reaching $3.2 billion on the full year.

Kesimpta 成長了 49%，全年銷售額達到 32 億美元。

It was outpacing both the B cell and the MS market.

其發展速度超過了 B 細胞和 MS 市場。

We're really pleased by the performance in the US and also very solid performance outside of the United States, growing 42% in the US with TRx growth at 29%.

我們對美國市場的表現感到非常滿意，美國市場以外市場的表現也非常穩健，美國市場成長了 42%，TRx 成長了 29%。

We're outpacing the B-cell segment.

我們正在超越 B 細胞領域。

We see our NBRx share in the high 20s in the B-cell segment.

我們發現 NBRx 在 B 細胞領域的份額達到 20% 左右。

Outside of the United States, we had 67% constant currency growth, which we're really pleased with.

在美國以外，我們的固定匯率成長率為 67%，我們對此感到非常滿意。

Overall, 70% of the new patients in the United States are first line or first switch. 80% of the US commercial lives have been -- have now first-line coverage.

整體而言，美國 70% 的新患者都是第一線治療或首次轉診治療。 80% 的美國商業生活已經——現在已經得到一線覆蓋。

So we're in a very good position from that standpoint.

因此從這個角度來看，我們處於非常有利的地位。

And we are right now the number one NBRx naive medicine and seven out of the 10 ex US market.

目前，我們是排名第一的 NBRx 初治藥物，在美國以外市場佔有 10 席，佔 7 席。

So I think the setup overall for Kesimpta looks really good, very strong performance.

所以我認為 Kesimpta 的整體設定看起來非常好，性能非常強大。

US and ex-US, and that gives us confidence in reaching the peak sales guidance that we've set out for this brand.

美國和美國以外的地區，這使我們有信心達到為該品牌設定的最高銷售預期。

Now, moving to slide 9.

現在轉到第 9 張投影片。

Kisqali grew 49% in the full year, reaching $3 billion in sales, and this is a reflection of both of the strong performance we're seeing in the metastatic setting and in the early breast cancer setting.

Kisqali 全年成長了 49%，銷售額達到 30 億美元，這反映了我們在轉移性乳癌和早期乳癌領域看到的強勁表現。

So as you can see in the middle panel here, we've outlined the total brand NBRx across the market, and you can see the significant increase we've seen in total brand NBRx post the approval in early breast cancer and the positive NCCN guidelines.

因此，正如您在中間面板中看到的，我們概述了整個市場的總品牌 NBRx，您可以看到，在早期乳癌獲得批准後，總品牌 NBRx 顯著增加，並且 NCCN 指南也積極。

The brand grew 65% in the US in quarter four.

該品牌第四季在美國成長了 65%。

We have metastatic share at 50% now and TRx share at 33% and climbing.

目前，我們的轉移性份額為 50%，TRx 份額為 33%，且仍在上升。

In the EBC setting, the early breast cancer setting, we've already reached 52% in VR share within three months of launch.

在EBC環境，也就是早期乳癌環境中，我們在推出後的三個月內就已經達到了52％的VR份額。

And so, we're getting very positive feedback from physicians and seeing solid uptake both in node-negative and node 1 patients without risk factors as well as the overlapping node 1 and node 2+ patient population.

因此，我們從醫生那裡得到了非常積極的回饋，並且看到沒有風險因素的淋巴結陰性和淋巴結 1 患者以及重疊的淋巴結 1 和淋巴結 2+ 患者群體的穩步接受。

I mentioned the category 1 NCCN guidelines, which is really positive for the brand.

我提到了 1 類 NCCN 指南，這對品牌來說確實有正面意義。

And importantly, as well, we announced this morning that we've settled the compound patent litigation with a generic manufacturer and that supports Kisqali US patent protection until at least Q1 2031.

同樣重要的是，我們今天上午宣布，我們已經與一家仿製藥製造商解決了化合物專利訴訟，並支持 Kisqali 美國專利保護至少到 2031 年第一季。

Outside of the United States, we grew 34% in constant currency with a leading share.

在美國以外，我們以固定匯率計算成長了 34%，並且佔據領先地位。

NBRx share at 42%.

NBRx 份額為 42%。

The early breast cancer launch is ongoing now in Europe and other geographies, and that should provide a further driver of growth for Kisqali over the course of the year of this year.

早期乳癌藥物目前正在歐洲和其他地區上市，這將為 Kisqali 在今年的成長提供進一步的動力。

So we guided to $8 billion plus, and I think the early signals are clearly indicating that we're going to be able to get there and hopefully do better.

因此，我們預計目標金額將超過 80 億美元，我認為早期訊號清楚地表明，我們將能夠實現這一目標，並且希望做得更好。

Now, moving to slide 10.

現在，轉到第 10 張投影片。

Pluvicto delivered full year sales of $1.4 billion, 42% in constant currencies in the post-tax ascending.

Pluvicto 全年銷售額為 14 億美元，以稅後固定匯率計算成長 42%。

And most importantly, we spent a lot of our energy in quarter four, laying the foundation for the pretax AMPS of May 4 launch, which we expect in the first half.

最重要的是，我們在第四季度投入了大量精力，為 5 月 4 日推出的稅前 AMPS 奠定了基礎，我們預計 AMPS 將在上半年推出。

Now, when you look at the quarter, we grew, you can see 28%.

現在，當您查看本季時，我們成長了 28%。

Overall, our performance was absolutely in line with what we guided to in our quarter three conference call.

整體而言，我們的業績完全符合我們在第三季電話會議上的預期。

US was up 12%.

美國上漲了12%。

We achieved 40% NBRx share within the vision population.

我們在視力族群中實現了 40% 的 NBRx 份額。

Pluvicto is now available in over 20 countries outside of the United States.

Pluvicto 目前已在美國以外的 20 多個國家上市。

And we're confident that we can now accelerate growth with the PSMA 4 launch in 2025.

我們有信心，隨著 2025 年 PSMA 4 的推出，我們可以加速成長。

The final OS was read out over the course of January with HR -- unadjusted hazard ratio of 0.91. And you can see the confidence intervals here.

最終的 OS 是在一月讀出的，HR－未調整風險比為 0.91。您可以在這裡看到置信區間。

The file has been submitted to the FDA last year, and the review is ongoing.

該文件去年已經提交給FDA，審查仍在進行中。

And as we -- so far, there's no [adcom] plan for this brand.

到目前為止，我們還沒有針對該品牌的 [adcom] 計劃。

So I think that's really a positive signal, and we'll see now how quickly we can get to launch.

所以我認為這真的是一個積極的信號，我們現在將看看我們能多快推出。

We have over 590 sites open for the brand; 350 sites are actively ordering.

我們為該品牌開設了 590 多個網站； 350個站點正在積極訂購。

And every month, every week, we're adding more sites.

每個月、每週我們都會增加更多的網站。

We're getting more sites actively order.

我們正在讓更多站點積極訂購。

We're getting further into community oncology which will set us up not only for Pluvicto, but our broader RLC pipeline over time.

我們正在進一步深入社區腫瘤學，這不僅將為我們建立 Pluvicto 基礎，而且將為我們更廣泛的 RLC 管道奠定基礎。

And we expect the initial uptake for PSMA 4 to come primarily from the depth we'll get in these existing sites and then grow over time, certainly as we try to reach deeper into the oncology community practices.

我們預計，PSMA 4 的初始應用主要來自於我們在這些現有站點的深入研究，然後隨著時間的推移而增長，當然，當我們嘗試更深入地融入腫瘤學社區實踐時。

We're also progressing on our efforts to expand Pluvicto further and as well as our broader RLC expansion.

我們也正在努力進一步擴大 Pluvicto 以及更廣泛的 RLC 擴展。

The PSMA addition readout is on track for the second half of this year.

PSMA 附加條款的公佈預計將在今年下半年順利完成。

We have Pluvicto filings ongoing in China and Japan.

我們正在中國和日本進行 Pluvicto 的申請。

And in both of those geographies as well.

而這兩個地區都是如此。

We've announced manufacturing facilities to support the launch of Pluvicto and, of course, Lutathera.

我們已經宣布了製造設施來支持 Pluvicto 和 Lutathera 的推出。

And we've also now initiated planning for our actinium PSMA-617 Phase 3 study, the first of two actinium studies, we're now planning to move into Phase 3 on to have continued life cycle management in prostate cancer with radioligand therapies.

我們現在也開始規劃我們的錒系PSMA-617 第三階段研究，這是兩項錒系研究中的第一項，我們現在計劃進入第三階段，繼續使用放射性配體療法對前列腺癌進行生命週期管理。

Now, moving to slide 11.

現在轉到第 11 張投影片。

Leqvio showed a steady trajectory delivered 114% constant currency full year growth in the quarter, 83% growth versus prior year.

Leqvio 呈現穩定的成長軌跡，本季實現 114% 的固定匯率全年成長，比去年同期成長 83%。

We're really pleased that now in the US our growth is outpacing the overall advanced lipid lowering market.

我們非常高興，現在在美國，我們的成長速度超過了整體高級降脂市場。

We have over 3,000 health systems ordering now Leqvio that represents 68% of the overall market volume.

目前，我們有超過 3,000 個醫療系統訂購 Leqvio，佔整個市場銷售量的 68%。

We have depth that's increasing, and I think we're getting better and better traction with the overall buy-and-bill comfort levels within cardiology practices.

我們的深度不斷增加，我認為我們在心臟病學實踐中的整體購買和付款舒適度方面取得了越來越好的進展。

We see demand growth in all relevant channels.

我們看到所有相關管道的需求都在成長。

Outside of the United States, we've seen robust growth as well.

在美國以外，我們也看到了強勁的成長。

Leqvio is now registered in over 100 countries.

Leqvio 目前已在 100 多個國家註冊。

We see solid uptake in markets such as Germany.

我們看到德國等市場的成長勢頭強勁。

And in China, our out-of-park growth really makes it one of the top ranked markets we have outside of the United States.

在中國，我們的場外成長確實使其成為美國以外排名靠前的市場之一。

We have an ongoing launch as well now in Japan.

目前，我們在日本也正在進行發布。

So looking ahead, we have a number of clinical stage readouts coming over the course of 2025, which will help, I think, round out the profile of Leqvio as we await the outcomes, trials, readouts in secondary prevention in 2026 and 2027.

因此展望未來，我們將在 2025 年公佈一系列臨床階段讀數，我認為這將有助於完善 Leqvio 的概況，因為我們正在等待 2026 年和 2027 年的二級預防結果、試驗和讀數。

Now, moving to slide 12.

現在，轉到第 12 張投影片。

Scemblix grew 68% for the full year with continued momentum in the third line setting and early progress that we're already seeing in the frontline setting.

Scemblix 全年成長了 68%，在第三線領域繼續保持成長勢頭，並且在前線領域也已取得早期進展。

We're a market leader now in the third-line CML setting with NBRx share of 49%.

我們目前是三線 CML 市場的領導者，NBRx 份額為 49%。

We're 3 times higher than the nearest competitor, which I think shows how well established now Scemblix is amongst hematologists.

我們比最接近的競爭對手高出 3 倍，我認為這表明 Scemblix 在血液學家中的地位已經很高。

Outside of the United States, our leadership is at 66% for NBRx and total patient share in our key markets.

在美國以外，我們在主要市場的 NBRx 和總患者份額均佔據 66% 的領先地位。

And when you look at the earlier line launch, what was critical is that we have already received NCCN Category 1 preferred recommendation in November.

當您查看早期的產品線發佈時，關鍵的一點是，我們已經在 11 月獲得了 NCCN 1 類優先推薦。

And then we also already see now Scemblix is the fastest-growing TKI by NBRx share across all lines of therapy and we're the market leader now in second-line NBRx with a share already at 29%.

然後，我們現在也看到，以 NBRx 份額計算，Scemblix 是所有治療系列中成長最快的 TKI，我們現在是二線 NBRx 市場的領導者，份額已經達到 29%。

And that's just in the first few months of launch.

這只是推出後​​的頭幾個月。

So assuming we can really drive that continued trajectory, we should see a very strong uptake overall for Scemblix in the coming quarters.

因此，假設我們真的能夠推動這一持續的發展軌跡，我們應該會看到 Scemblix 在未來幾季整體上呈現非常強勁的成長勢頭。

So we're confident in the global first-line opportunity.

因此，我們對全球一線機會充滿信心。

We read out the 96-week data recently as well, which reinforces superior efficacy, and I'll say more about that in a moment.

我們最近也讀出了 96 週的數據，這進一步證明了卓越的療效，稍後我會詳細介紹這一點。

And then we also showed some very good data that showed treatment discontinuation as well that Scemblix provides a clear profile win over nilotinib.

然後我們也展示了一些非常好的數據，顯示治療停止後，Scemblix 明顯優於尼洛替尼。

Now, going to slide 13.

現在，翻到第 13 張投影片。

That ASC4FIRST 96-week data reinforce superior efficacy and safety.

ASC4FIRST 的 96 週數據證實了其卓越的功效和安全性。

When you look at the data set here at 96 weeks on the left-hand side of the chart, you can see against all TKIs, we continued to show a significant improvement, a statistically significant improvement in major molecular response similarly versus imatinib a significant improvement in major molecular response.

當你查看圖表左側96 週的數據時，你可以看到，與所有TKI 相比，我們繼續顯示出顯著改善，主要分子反應在統計學上顯著改善，與伊馬替尼相比同樣顯著改善在主要分子反應。

And while we weren't powered our point estimate difference against second gen TKIs continues to improve as well over time.

儘管我們沒有能力，但我們與第二代 TKI 的點估計差異也隨著時間的推移而不斷改善。

Now, when you look at the safety profile, we maintained a very excellent safety profile that we had at the earlier time point, whether it was grade 3 AEs, AEs leading to discontinuation or AEs leading to dose interruption, an excellent profile for the brand.

現在，當你查看安全性概況時，我們保持了早期非常出色的安全性概況，無論是3 級不良事件、導致停藥的不良事件還是導致劑量中斷的不良事件，對於該品牌而言都是非常出色的概況。

So overall, we offer here a medicine that has high efficacy, compelling safety.

總的來說，我們提供一種高效、安全的藥物。

And we believe over time, as there's more and more experience, we'll become the preferred agent in first, second, and third line for CML patients.

我們相信，隨著時間的推移和經驗的積累，我們將成為 CML 患者一線、二線和三線的首選藥物。

We move to slide 14.

我們轉到第 14 張投影片。

Now, turning to Fabhalta.

現在，轉向 Fabhalta。

As you're well, Fabhalta has now launched in two indications in PNH and IgAN.

如您所知，Fabhalta 現在已在 PNH 和 IgAN 兩種適應症中推出。

And while it's early days, I think we see really solid, steady performance for this brand, a 23% volume growth in PNH.

雖然還處於早期階段，但我認為我們看到該品牌的表現確實穩固，PNH 的銷量成長了 23%。

Most of the source of business at the moment is switch patients from the established therapies.

目前大部分業務來源是從既定療法轉換過來的患者。

We see over 90% of patients staying on therapy after the -- continuing after their first refill, very good commercial coverage levels.

我們發現超過 90% 的患者在第一次續藥後繼續接受治療，商業覆蓋水準非常好。

We're approved now in 40 countries.

我們目前已獲得 40 個國家的批准。

And so, step by step as well, we're progressing the launch in other geographies.

因此，我們也逐步推動其他地區的推廣工作。

The early signs for the IgAN launch as well are very encouraging.

IgAN 推出的早期跡像也非常令人鼓舞。

We've seen strong access with 67% commercial coverage already to label.

我們已看到強勁的訪問量，商業標籤覆蓋率已達到 67%。

We're seeing a number of nephrologists, a sizable number of nephrologists, completing REMS certification.

我們看到許多腎病專家，相當多的腎病專家完成了 REMS 認證。

And we also see a high interest in our conversations with opinion leaders on the Fabhalta MOA.

我們也發現，大家對與意見領袖就 Fabhalta MOA 進行的對話表現出很高的興趣。

One other update we have as well for Fabhalta is that the C3G filing was completed in quarter four.

我們還為 Fabhalta 提供的另一個更新是，C3G 備案已於第四季度完成。

We received priority review.

我們獲得了優先審查。

The FDA has confirmed no Adcom for C3G.

FDA 已確認沒有針對 C3G 的 Adcom。

So we're now preparing for a launch in the first half of 2025.

因此，我們現在正準備在 2025 年上半年推出。

So moving to slide 15.

現在轉到投影片 15。

So when you look across the full year, I think we delivered very good innovation momentum across regulatory decisions, submissions, readouts, and Phase 3 starts.

因此，回顧全年，我認為我們在監管決策、提交、讀出和第三階段啟動方面都表現出了非常好的創新勢頭。

Obviously, the critical approvals were delivered upon, particularly the Kisqali early breast cancer, Fabhalta approvals, the filings of Pluvicto and the approval for Scemblix, so I think we really are looking forward to maintaining and continuing that momentum in the year to come.

顯然，關鍵的批准已經獲得，特別是 Kisqali 早期乳腺癌、Fabhalta 的批准、Pluvicto 的申請以及 Scemblix 的批准，所以我認為我們真的期待在來年保持並繼續這一勢頭。

One important readout that we did have in quarter four, turning to slide 16, was for the STEER study for OAV101 IT.

我們在第四季確實有一份重要的讀數，翻到第 16 張投影片，是針對 OAV101 IT 的 STEER 研究。

This is the intrathecal version of Zolgensma that is administered intrathecally at roughly 1/10 the dose of what we see in the IV administration.

這是 Zolgensma 的鞘內版本，其鞘內給藥劑量約為靜脈注射劑量的 1/10。

This was tested in children and young adults over two years of age.

這項測試在兩歲以上的兒童和青少年中進行了測試。

We're really pleased to see that we've met the primary endpoint for an increase versus baseline for the Hammersmith score, HFMSE, which is the gold standard.

我們非常高興地看到，我們已經達到了主要終點，即 Hammersmith 評分（HFMSE）相對於基線有所增加，這是黃金標準。

Not all of the therapies in the space have been tested against the Hammersmith score.

並非所有該領域的療法都經過了哈默史密斯評分的測試。

So we chose the gold standard, and we demonstrated that we met the primary endpoint of a statistically significant improvement versus a sham or placebo as requested by FDA.

因此，我們選擇了黃金標準，並證明我們達到了 FDA 要求的與假治療或安慰劑相比具有統計學顯著改善的主要終點。

A very favorable safety profile consistent with what we've seen in other settings.

與我們在其他環境中看到的情況一致，安全性非常良好。

We're looking forward to present the data at an upcoming medical congress.

我們期待在即將舉行的醫學大會上展示這些數據。

You can see the study design over on the right.

您可以在右側看到研究設計。

And our goal here will be to try to secure a broad indication across the various ACE levels and looking forward then to advance this global regulatory submissions across the various geographies.

我們的目標是嘗試確保在各個 ACE 層級上獲得廣泛的適應症，然後期待在各個地區推廣全球監管提交。

A sizable number of patients have not had the opportunity to benefit from Zolgensma in the first six months of life.

相當多的患者在出生後的前六個月沒有機會從 Zolgensma 中受益。

And now we're really excited now to give those patients a very compelling onetime treatment option that can hopefully stabilize and potentially improve their disease.

現在我們非常高興能夠為這些患者提供非常有效的一次性治療選擇，希望能夠穩定甚至改善他們的病情。

Now, moving to slide 17.

現在轉到第 17 張投影片。

We also completed an exciting deal in our neuroscience pipeline.

我們還在神經科學領域完成了一項令人興奮的交易。

This is for votoplam, PTC518.

這是 votoplam，PTC518。

It's a potential first-in-class oral disease-modifying therapy for Huntington's disease.

這是一種潛在的首創的治療亨廷頓舞蹈症的口服疾病改良療法。

We have a lot of expertise in oral splicing agents.

我們在口服接合劑方面擁有豐富的專業知識。

We had a molecule called LMI070, which ultimately did not progress because of peripheral neuropathy signals that we had during the development program.

我們有一種名為 LMI070 的分子，由於我們在開發計劃期間收到的周邊神經病變訊號，它最終沒有取得進展。

So this is a space we know well, and we really believe PTC518 has a very strong profile as evidenced in the interim readout of their Phase 2 study.

因此，這是我們非常了解的領域，我們確實相信 PTC518 具有非常強大的影響力，這從其第二階段研究的中期結果中可以看出。

As you know, in Huntington's disease, a very fatal neurodegenerative disease with really no disease-modifying therapies at the moment.

眾所周知，亨丁頓舞蹈症是一種非常致命的神經退化性疾病，目前尚無可以改善病情的療法。

Prevalence is 37,000 in the US and 28,000 in EU.

美國患病人數為 37,000 人，歐盟患病人數為 28,000 人。

So we have an opportunity, hopefully, to make a big difference.

因此，我們希望有機會做出重大改變。

We would expect the Phase 2 readout for the study in the first half of 2025 and then moving to pivotal Phase 3 studies thereafter.

我們預計研究的第 2 階段將在 2025 年上半年完成，然後進入關鍵的第 3 階段研究。

Then moving to slide 18.

然後移至幻燈片 18。

So our goal will be to continue our innovation momentum in 2025.

因此，我們的目標是在 2025 年繼續保持創新動能。

We outlined to meet the management.

我們概述了與管理層的會面。

We have a deep and broad pipeline across our four therapeutic areas across our key platform and our goal now is to advance the next wave of therapies, both in terms of approvals and submissions.

我們在主要平台的四個治療領域擁有深入而廣泛的產品線，我們現在的目標是推動下一波治療，包括獲得批准和提交。

You can see the list here, but also read out some study initiations, which will really fill up that mid-stage pipeline and then allow us to maintain our growth momentum well into the 2030s and beyond.

您可以在此處看到列表，也可以閱讀一些研究啟動，這些研究啟動將真正填補中期管道，然後使我們能夠在 2030 年代及以後保持增長勢頭。

So moving to slide 19 and to close, I just wanted to remind you of our confidence in our midterm guidance of 5% plus sales growth out to 2029 and a 40% core margin by 2027.

因此，轉到第 19 頁並結束之前，我只想提醒您，我們對中期指導充滿信心，即到 2029 年銷售額增長 5% 以上，到 2027 年核心利潤率達到 40%。

We're very comfortable that we can -- with our replacement power outpaced the GX impacts that we have to 2029.

我們非常有信心，到 2029 年，我們的替代能源將超過 GX 帶來的影響。

We have an exciting set of in-market growth drivers, many of which have protection well into the 2030s.

我們擁有一系列令人興奮的市場成長動力，其中許多動力將持續保護至 2030 年代。

We have the pipeline probabilized and are hopefully with positive clinical data and approval, that pipeline will become further unprobablized in medicines like remibrutinib, OAV, ianalumab, pelacarsen, and atrasentan can further drive the growth profile of the company.

我們已經對該管道進行了機率分析，並希望透過積極的臨床數據和批准，該管道在瑞布替尼、OAV、ianalumab、pelacarsen 和阿曲生坦等藥物中的應用將變得更加不可能，從而進一步推動公司的成長前景。

So an exciting year.

真是令人興奮的一年。

We're really excited about our performance in 2024 and excited about continuing delivering the strong results and strong innovation delivery into 2025.

我們對 2024 年的表現感到非常興奮，並對在 2025 年繼續提供強勁的業績和強大的創新交付感到興奮。

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

因此，我將把它交給哈利。

Yeah.

是的。

Thank you, Vas.

謝謝你，瓦斯。

Good morning, and good afternoon, everyone.

大家早安，下午好。

I'll now talk you through our financials for the fourth quarter and full year '24, which as Vas mentioned, has shown some of the strongest performance in our history.

現在我將向您介紹我們 2024 年第四季和全年的財務狀況，正如 Vas 所提到的，這是我們歷史上最強勁的表現之一。

As always, my comments refer to continuing operations and growth rates in constant currencies, unless otherwise noted.

像往常一樣，除非另有說明，我的評論指的是持續經營和以固定匯率計算的成長率。

So starting on slide 21, giving a bit of context -- our results in 2024, which is here on the far right of each of the three charts.

因此，從第 21 張投影片開始，提供一些背景資訊 - 我們的 2024 年業績，位於這三個圖表的最右邊。

It was really our first full year as a pure-play Innovative Medicines Company, and we continue to show a strong track record of sales growth with margin expansion.

這實際上是我們作為一家純創新藥物公司的第一個完整年度，我們繼續表現出強勁的銷售成長和利潤率擴大的記錄。

If you look back over the last five years, we have grown sales at a 7% CAGR and core operating income at a 15% CAGR through consistent, strong commercial execution and overall significant progress on operational productivity.

回顧過去五年，我們透過持續、強勁的商業執行和營運效率的整體顯著進步，銷售額實現了 7% 的複合年增長率，核心營業收入實現了 15% 的複合年增長率。

This has resulted in core margin expansion of 1,100 basis points in constant currencies, putting us on a clear path to achieve our midterm margin guidance of 40% plus by 2027.

這使得核心利潤率以固定匯率計算擴大了 1,100 個基點，使我們預計在 2027 年實現 40% 以上的中期利潤率預期。

I think when you look at this track record, it becomes very clear that we have lifted the company to a whole new level of sales, margin, and as we will discuss later, free cash flow.

我想當你看到這個業績記錄時，你會很清楚地看到我們已經將公司的銷售額、利潤率以及我們稍後將討論的自由現金流提升到了一個全新的水平。

Moving to slide 22.

移至投影片 22。

We guided to a low double-digit sales growth for full year 2024, and we achieved 12%, so meeting our guidance.

我們預計 2024 年全年銷售額將實現低兩位數成長，而實際成長率達到了 12%，符合我們的預期。

And for core operating income, we delivered 22% growth exceeding by 1 notch our guidance, reflecting the strong momentum we have seen in our priority brands, good also and launches as well as cost discipline throughout the end of the year, including some productivity gains.

核心營業利潤成長 22%，比預期高出 1 個等級，這反映了我們在重點品牌、新品發布和成本控制方面所看到的強勁勢頭，以及今年年底的成本控制，包括生產力的提高。

On slide 23, you see a summary of our financial performance.

在第 23 張投影片上，您可以看到我們的財務表現摘要。

In the quarter, sales were up 16%, and core operating income increased 29%.

本季銷售額成長16%，核心營業收入成長29%。

Core EPS was $1.98, up 33%.

核心每股收益為 1.98 美元，成長 33%。

To note, in quarter four, we benefited from some growth to net favorability, mainly in the US.

值得注意的是，第四季我們受益於淨有利性的一些成長，主要是在美國。

This added about 3% points of growth in quarter four from gross to net true ups based on invoices for prior quarters in 2024.

根據 2024 年前幾季的發票，第四季的毛利潤到淨利潤成長了約 3%。

So the underlying growth in quarter four has been a very strong 13%, slightly better than the 12% sales growth for the full year in 2024.

因此，第四季的潛在成長率非常強勁，達到 13%，略高於 2024 年全年 12% 的銷售成長率。

For the full year, core margin expanded 330 basis points versus prior year in constant currencies to reach 38.7%.

以固定匯率計算，全年核心利潤率較前一年擴大 330 個基點，達到 38.7%。

Core EPS was $7.81, up 24%.

核心每股收益為 7.81 美元，成長 24%。

And free cash flow grew 24% to $16.3 billion, a record high for Novartis.

自由現金流成長 24% 至 163 億美元，創下諾華的歷史新高。

Now, speaking of free cash flow, let's turn to the next slide.

現在，說到自由現金流，讓我們翻到下一張投影片。

You can see free cash flow generation has really accelerated since we completed our transformation into a pure-play pharma company end of 2023 and also finalized our transformation program, Transformation for Growth program, which we announced April '22.

您可以看到，自從我們在2023 年底完成向純製藥公司的轉型並最終確定我們的轉型計劃（即我們於22 年4 月宣布的“轉型增長”計劃）以來，自由現金流的產生確實加速了。

This has been a focus for us to, of course, ensure that not only core operating income increases, but appropriately also free cash flow, so high quality of core earnings and strong free cash flow generation.

當然，這一直是我們關注的重點，以確保不僅核心營業收入增加，而且自由現金流也適當增加，從而實現高品質的核心盈利和強勁的自由現金流產生。

And in fact, we have generated more cash than we did as combined businesses, be it with Sandoz or a few years back, even with Alcon.

事實上，無論是與 Sandoz 合併，還是幾年前與 Alcon 合併，我們所創造的現金都比合併時更多。

This gives us also ample capacity, of course, to reinvest in the business pursue bolt-on deals and return attractive -- attractively to our shareholders while growing dividends and buybacks.

當然，這也為我們提供了充足的能力，可以對業務進行再投資，進行附加交易，並為我們的股東帶來有吸引力的回報，同時增加股息和回購。

This brings me to my next slide.

這讓我想到了下一張投影片。

So we continue to execute in line with our shareholder-friendly capital allocation strategy, which balances the priorities I mentioned.

因此，我們繼續按照對股東友好的資本配置策略執行，以平衡我提到的優先事項。

We invest over $9 billion in R&D in 2024 and completed more than 30 bolt-on deals over the last two years to strengthen our pipeline, particularly in the area of neuroscience RLT and renal.

我們在 2024 年投資超過 90 億美元用於研發，並在過去兩年中完成了 30 多項附加交易，以加強我們的產品線，特別是在神經科學 RLT 和腎臟領域。

With respect to returning capital to shareholders, we remain committed to consistently growing our dividend in Swiss francs per share and completing our ongoing share buyback, which has about $5.4 billion still to be executed in 2025.

在向股東返還資本方面，我們將繼續致力於持續增加每股瑞士法郎的股息，並完成我們正在進行的股票回購，其中約 54 億美元將於 2025 年執行。

Now, on to the next slide, please, to the dividend.

現在，請翻到下一張投影片，討論紅利。

So we are really pleased to propose the 28th consecutive dividend increase to CHF3.50 per share. an increase of 6% in Swiss francs and [28th of them] after the prior few years of [10] per year.

因此，我們非常高興地提議連續第 28 次增加股息至每股 3.50 瑞士法郎。以瑞士法郎計算，成長了 6%，比前幾年的每年 [10] 成長了 [28]%。

As you know, we did not rebase our dividend for the spin-off of Sandoz, no Alcon.

如你所知，我們並沒有因為 Sandoz 和 Alcon 的分拆而調整股息。

So this represents really an attractive, consistent growth over time, in line with our commitment to our shareholders.

因此，這確實代表著一種具有吸引力、持續的長期成長，符合我們對股東的承諾。

Moving to slide 27.

移至第 27 張投影片。

For full year 2025, we expect continued strong sales growth with margin expansion, with sales growing mid- to high single digit and core operating income growing high single to low double digits.

對於 2025 年全年，我們預計銷售將持續強勁成長，利潤率將擴大，銷售額將以中高個位數成長，核心營業收入將以高個位數至低兩位數成長。

Embedded in our guidance with the financial planning assumption that Tasigna, Promacta, and Entresto US generics entry occurs in the middle of, and I'll give some more detail on expected half one versus half two dynamics on the next slide.

在我們的指導中嵌入了財務規劃假設，即 Tasigna、Promacta 和 Entresto 美國仿製藥的進入發生在中間，我將在下一張幻燈片中詳細介紹預期的第一半與第二半的動態。

To complete our full year guidance, please note that we 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%。

On slide 28, we have shown illustratively how we expect half one and half two dynamics should generics for Entresto, Tasigna, and Promacta enter in US in mid of 2025 as per our financial planning assumption.

在投影片 28 中，我們以範例方式展示了根據我們的財務規劃假設，如果 Entresto、Tasigna 和 Promacta 的仿製藥在 2025 年中期進入美國，我們預計一半和一半的動態。

Overall, we expect continued strong volume growth from priority brands in 2025.

整體而言，我們預計 2025 年優先品牌的銷售將持續強勁成長。

In half one, we expect sales to grow low double digit while we expect, of course, a softer half due to the impact of the three potential generic entries with low to mid-single-digit sales growth.

我們預計上半年銷售額將達到低兩位數成長，同時，由於三種潛在仿製藥的影響，我們預計上半年銷售額將呈現低至中個位數的增幅，當然，我們預計下半年銷售額會較為疲軟。

Likewise, we expect half one corp inc to grow the high teens versus low to mid-single-digit growth in half two.

同樣，我們預計一半的公司將實現高十幾率的成長，而一半的公司將實現低到中等個位數的成長。

And finally, let's have a quick look at the currencies as they always move around.

最後，讓我們快速看一下貨幣的變動情況。

And if late January rates were to prevail for the remainder of 2025, we would expect the full year currency impact to be a negative 2% on sales and a negative 3 percentage points on core operating income.

如果 2025 年剩餘時間 1 月底的利率維持不變，我們預期全年匯率影響將對銷售額造成負 2%，對核心營業收入造成負 3 個百分點。

As a reminder, we always provide an estimated impact of exchange rates on our results on a monthly basis on our website.

提醒一下，我們始終會在網站上每月提供匯率對我們結果的估計影響。

And with that, I hand back to Vas.

說完，我將手交還給了 Vas。

Terrific.

了不起。

Thank you, Harry.

謝謝你，哈利。

So coming to the final slide, and really, just in summary, continued strong business momentum in quarter four, one of the best financial performances in the company's history, met and exceeded our full year guidance.

所以來到最後一張投影片，實際上，總而言之，第四季度繼續保持強勁的業務勢頭，這是公司歷史上最好的財務表現之一，達到並超越了我們的全年預期。

We're advancing our pipeline, including new approvals, but importantly, readouts for assets that will fuel our mid- to long-term growth and really ensuring we advance the mid-stage pipeline.

我們正在推進我們的管道，包括新的批准，但重要的是，對資產的解釋將推動我們的中長期成長，並真正確保我們推進中期管道。

And expect to continue strong sales growth with margin expansion in 2025, as Harry outlined.

正如 Harry 所概述的，預計 2025 年銷售額將繼續強勁增長，利潤率也將擴大。

And we remain on track to deliver our midterm guidance of 5% plus sales growth through 2029.

我們仍有望實現中期預期，即 2029 年銷售額將成長 5% 以上。

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

因此，莎倫，我們可以開始提問了。

(Operator Instructions) Florent Cespedes, Bernstein.

（操作員指令） Florent Cespedes，伯恩斯坦。

Good afternoon.

午安.

Thank you very much for taking my question.

非常感謝您回答我的問題。

A quick one on the guidance as the guidance is a little bit better than expected on the top line, but also on the margin.

快速了解指引，因為指引在營收方面比預期好一點，但在利潤率方面也比預期要好一點。

And as Entresto is a very profitable product and that you will lose percent in Europe generics from the mid of this year.

由於 Entresto 是一款利潤豐厚的產品，從今年年中開始，歐洲仿製藥市場的利潤將下降百分之幾。

I was just wondering if you could elaborate, Harry, what are -- where we should see some pressure?

我只是想知道你能否詳細說明一下，哈利，我們應該在哪裡看到一些壓力？

And where you will have some growth that will offset the generic impact on the P&L and on the top line.

並且您將獲得一些成長來抵消對損益表和營業額的一般影響。

Thank you.

謝謝。

Thanks, Florent.

謝謝，弗洛朗。

Harry?

哈利？

Yes.

是的。

Thank you, Florent.

謝謝你，弗洛朗。

I mean, in the end, it all starts with the top line, as we all know, in the pharma businesses.

我的意思是，最終，正如我們所知，在製藥業，一切都從營收開始。

So having our mid- to high single-digit sales growth, given the strength of our growth brands and launches -- that's a good starting base.

因此，考慮到我們成長品牌和新產品的實力，我們的銷售額實現了中高個位數成長——這是一個很好的起點。

And also, our other products are quite profitable.

而且我們的其他產品的利潤也相當高。

Now, of course, profitability does vary by the different brands.

當然，不同品牌的獲利能力確實存在差異。

But overall, with the mid- to high single-digit sales growth and our ongoing resource allocation and productivity programs, we are very confident that with that, we will have also some moderate margin increase, right?

但總體而言，隨著中高個位數的銷售額成長以及我們正在進行的資源配置和生產力計劃，我們非常有信心，我們的利潤率也會有所提高，對嗎？

So from that standpoint, and I laid out half one, we will be more, obviously.

所以從這個角度來看，正如我已經提到的那樣，我們顯然會做得更多。

And if these generics would enter half two would be basically pretty much low to mid-single digits, both on top and bottom line.

如果這些仿製藥能夠進入半壁江山，那麼營收和利潤基本上都會處於低點到中等個位數之間。

That's fine.

沒關係。

But overall, very confident in that sales growth with these assumptions as well as this -- the underlying volume growth when you look at it, right, 14% -- 15% volume.

但總體而言，基於這些假設以及從根本上的銷售成長，我們對銷售成長非常有信心，是 14% - 15% 的銷量。

And then it depends a bit pricing was quite neutral last year, and then it depends simply on generic assumptions there.

然後這取決於去年的定價是否相當中性，然後它僅取決於那裡的一般假設。

But also with a 5%, very confident the 5% CAGR on the five years, and then, of course, from 38.7% to 40% plus, it's not that far, right, in 2027.

但也有 5% 的成長率，非常有信心，五年內複合年增長率為 5%，然後，當然，從 38.7% 到 40% 以上，也不是那麼遠，在 2027 年。

But we have good ongoing productivity and therefore, especially on SG&A with good resource allocation and the launches are mostly in areas where we have already strong presence, we would expect SG&A to grow below sales growth as you have also seen in the prior two years.

但是我們擁有良好的持續生產力，因此，特別是在銷售、一般及行政開支方面，我們擁有良好的資源配置，而且新推出的產品大多是在我們已經擁有強大影響力的領域，我們預計銷售、一般及行政開支的成長將低於銷售額的成長，正如您在前兩年所看到的。

Simon Baker, Redburn Atlantic.

西蒙貝克 (Simon Baker)，雷德伯恩大西洋公司 (Redburn Atlantic)。

Thanks for taking my question.

感謝您回答我的問題。

And it's kind of a continuation from Florent question.

這有點像是 Florent 問題的延續。

Just mindful of the lots of exclusivity potentially for Entresto later in the year.

只是要記住，今年稍後 Entresto 可能會獲得大量獨家經營權。

Historically, you have been very, very good at managing gross margin through patent expires.

從歷史上看，你們非常擅長在專利到期期間管理毛利率。

I just wonder, Harry, I know you don't guide on gross margin.

我只是想知道，哈利，我知道你不指導毛利率。

If you could just give us any commentary around the resilience of the gross margin in 2025 in light of that event?

鑑於該事件，您能否對 2025 年毛利率的彈性做出一些評論？

Thanks so much.

非常感謝。

Thanks, Simon.

謝謝，西蒙。

So as I mentioned on prior calls and IR road shows -- the further margin improvement, I expect to basically fully come from SG&A as we -- with good resource allocation, basically slightly grow at G&A, but significantly below sales growth, right?

因此，正如我在之前的電話會議和投資者關係路演中提到的那樣- 我預計利潤率的進一步提高基本上完全來自銷售、一般和行政費用- 因為我們有良好的資源配置，銷售、一般和行政費用基本上會略有增長，但會大大低於銷售額的增長，對嗎？

The gross margin comes a little bit under pressure as we lose small molecules where we don't pay royalties with either small molecules where we pay some royalties or larger molecules.

由於我們失去了不支付特許權使用費的小分子產品，無論是支付部分特許權使用費的小分子產品，還是支付較大分子產品，毛利率都受到了一定壓力。

But -- all of that will be more than offset by the SG&A efficiencies.

但是——所有這些都將被銷售、一般及行政費用的效率所抵消。

And then, of course, also our colleagues in manufacturing and supply chain continue to work on very good productivity programs and have cost reduction programs on each of our products in a very impressive way. of course, never compromising quality of supply, very high 99.5% plus supply customer service levels.

當然，我們的製造和供應鏈同事也繼續致力於非常好的生產力計劃，並以非常令人印象深刻的方式對我們的每種產品實施成本削減計劃。當然，我們絕對不會降低供應質量，99.5% 以上的供應客戶服務水準非常高。

And with that, a little bit pressure on the gross margin because of increasing royalties but by far, compensated from SG&A efficiencies.

由於特許權使用費的增加，毛利率會面臨一點壓力，但到目前為止，銷售、一般及行政費用的效率已經彌補了這種壓力。

Great.

偉大的。

Thanks so much.

非常感謝。

Richard Parkes, BNP Paribas.

法國巴黎銀行的理查帕克斯 (Richard Parkes)。

Hi.

你好。

Thanks for taking my question.

感謝您回答我的問題。

I think I'll take one on the Huntington's program.

我想我會選擇亨廷頓計劃。

Obviously, a huge unmet medical need, terrible disease, but there have been some of the failures in that area in the past.

顯然，這是一個巨大的未滿足的醫療需求，這是一個可怕的疾病，但過去該領域也出現過一些失敗。

So I'm just wondering what makes you more confident in the approach what you've learned from those past experiences.

所以我只是想知道什麼讓你對從過去的經驗中學到的方法更有信心。

And to what degree do you think the PIVOT HD trial will derisk the probability of success given it's a slowly progressive disease in the studies relatively short?

鑑於該疾病在相對較短的研究中進展緩慢，您認為 PIVOT HD 試驗在多大程度上會降低成功的可能性？

Or will we still be seeing it as a high-risk program?

或者我們仍將其視為一個高風險的項目？

That would be really helpful.

這將會非常有幫助。

Thank you.

謝謝。

Yes.

是的。

Thanks, Richard.

謝謝，理查。

And I think as you're aware, the goal here is to take down mutant Huntington, but at a level where you're not taking it so low that you have some -- you have adverse consequences from reducing Huntington's too much.

我想你們也知道，這裡的目標是消滅突變的亨廷頓舞蹈症，但是不能將其控制得太低，否則，如果過度減少亨廷頓舞蹈症，就會產生不利的後果。

I mean, generally speaking, the feeling in the field if you want to reduce mutant huntingtin protein by 30% to 50%.

我的意思是，一般來說，如果你想將突變的亨廷頓蛋白減少 30% 到 50%，那麼該領域的感覺就是如此。

And then alongside that biomarker, you want to see clinical signs of improvement.

然後除了生物標記之外，您還希望看到臨床改善的跡象。

So I think that their interim results, PTC has shown the relevant mHTT lowering.

因此我認為他們的中期結果，PTC 已經顯示了相關的 mHTT 降低。

They've seen some signals of clinical efficacy and a very good safety profile without some of the peripheral neuropathies that we saw in our own programs.

他們已經看到了一些臨床療效的訊號和非常好的安全性，而且沒有出現我們在自己的專案中看到的一些週邊神經病變。

So I think all of that taken together makes the program looks like it's headed in the right direction.

所以我認為，綜合考慮所有這些因素，該計劃看起來正朝著正確的方向前進。

I think the big question, of course, is thus reducing a mutant Huntington at that level lead to a large enough or important enough clinical benefit that would lead to most importantly helping patients, but also regulatory approval.

我認為，當然，最大的問題是，將突變的亨廷頓基因減少到這種水平，是否會帶來足夠大或足夠重要的臨床益處，最重要的是幫助患者，同時也能獲得監管部門的批准。

I think we'll see how the Phase 2b study reads out.

我認為我們將會看到第 2b 階段的研究結果如何。

Obviously, if it's a very compelling result it might enable us to take it forward for a filing.

顯然，如果結果非常令人信服，我們可能會將其提交備案。

And if not, we would then need to go to a full pivotal study and then really answer the question does reducing mutant Huntington at that level lead to the clinical benefits that one would hope.

如果沒有，那麼我們就需要進行全面的關鍵研究，然後真正回答這個問題：將突變的亨廷頓基因減少到那個水平是否會帶來人們所希望的臨床益處。

So it's been -- I think PTC has developed a product in all the right ways.

所以我認為 PTC 已經以正確的方式開發了產品。

It's got good dialogue with the regulators.

它與監管機構進行了良好的對話。

So we're hopeful that we see a good result on the Phase 2b study, and then we'll take over and run those Phase 3 studies.

因此，我們希望看到第 2b 階段研究取得良好結果，然後我們將接手並執行第 3 階段研究。

And hopefully, we can bring an important first disease-modifying therapy to these patients who badly need it.

希望我們能為這些急需治療的患者帶來重要的首個疾病改良療法。

Thank you.

謝謝。

Emily Field, Barclays.

巴克萊銀行的艾米麗·菲爾德 (Emily Field)。

Hi.

你好。

Thanks for taking my questions.

感謝您回答我的問題。

The first one was just a clarification question from the first question that was asked by Florent.

第一個問題只是對 Florent 提出的第一個問題的澄清。

If you could just confirm the contribution of favorable gross net adjustments to sales in Q4 '24.

如果您能確認有利的總淨調整對 24 年第四季銷售額的貢獻。

And then I just wanted to ask a question about Pluvicto.

然後我只想問一個關於 Pluvicto 的問題。

I mean I know the guidance has been not to expect significant sales growth until the additional indication of PSMA 4 was added.

我的意思是，我知道指導意見一直是在增加 PSMA 4 的額外適應症之前不要指望銷售額會大幅增長。

But was there any particular driver between the sequential decline in the US quarter-over-quarter.

但美國季度季減是否有特殊驅動因素？

And would you expect any of the DTC and promotional efforts that you've been putting in place to have an impact on sales ahead of the PSMA for approval?

在 PSMA 獲得批准之前，您是否預期您所採取的 DTC 和促銷措施會對銷售產生影響？

Thank you.

謝謝。

Yes.

是的。

Thanks, Emily.

謝謝，艾米麗。

So back on the guidance, Harry?

那麼回到指導上來，哈利？

Yes.

是的。

So I think your question was about the gross to net and quarter four impacting the guidance.

所以我認為您的問題是關於毛利與淨利以及第四季度對指引的影響。

So let me try and then you can tell me if it was sufficient.

所以讓我嘗試一下，然後你告訴我是否足夠。

So we had we had a growth of 16% in quarter four, as you have seen in constant currency.

因此，正如您所看到的，按固定匯率計算，我們在第四季度實現了 16％ 的成長率。

About 3 points of that was due to true ups of gross to net for prior quarters of 2024.

其中約 3 個百分點是由於 2024 年前幾季的毛利潤與淨利潤的實際上漲。

So underlying 13%.

因此基礎值為 13%。

The full year sales by brand in 2024 is basically underscored.

2024年各品牌全年銷售量基本被壓低。

The underlying growth for '24 is 12%, right, as you see in the report.

正如您在報告中看到的，24年的潛在成長率是12％。

So if you want to have a basis, it's best to take the full year 2024 sales, and these are undistorted overall.

所以如果要有個基礎的話，最好是取2024年全年的銷售額，這些總體上是沒有失真的。

Now, of course, that has lifted the overall 2024 sales and we have, of course, computed that, if you will, into our 2025 gross to net calculation, right?

現在，當然，這提升了 2024 年的整體銷售額，當然，如果您願意的話，我們已經將其計算到了 2025 年的毛銷售額與淨銷售額的計算中，對嗎？

And a key element of this as really Medicaid utilization is continuously reducing to pre-pandemic levels.

其中一個關鍵因素是，醫療補助的使用率實際上正在持續下降至疫情前的水平。

Now, we do not assume that it gets lower and lower, we basically assume that in 2025, we see what we have seen at the latest for 2024, right, which is a reasonable assumption.

現在，我們並不假設它會越來越低，我們基本上假設在 2025 年，我們會看到最遲在 2024 年看到的水平，對吧，這是一個合理的假設。

So we never take risky assumptions on gross to net.

因此，我們從不對毛利與淨利做出冒險的假設。

It's obviously a big part of money, right, like $16 million to $20 billion of sales is we have like 50% of our US list prices be gross to net.

這顯然是很大一部分錢，對吧，例如 1600 萬到 200 億美元的銷售額，其中我們美國標價的 50% 是毛價和淨價。

But from that standpoint, it has lifted this more favorable gross to net situation for 2024, our sales level.

但從這個角度來看，它已經將 2024 年的毛銷售額與淨銷售額狀況提升到了更有利的水平。

And from that, we expect to grow mid- to high single digit.

從那時起，我們預計將實現中高個位數的成長。

I hope that clarifies your question.

我希望這能解釋你的問題。

On Pluvicto, when you look at it in Q4, it was really in line with what we had expected.

關於 Pluvicto，當你從第四季來看，它確實符合我們的期望。

In Q3, we had the benefit of some onetime adjustments in France and Germany.

第三季度，我們受益於法國和德國的一些一次性調整。

But then when you overall look at where we had guided for Q4, it's roughly -- exactly with where we had expected.

但當你整體看一下我們對第四季的預期時，它大致與我們的預期完全一致。

Now, I think looking ahead, we are hopeful to see further progress in the vision population, but I think that will be not a rapid increase.

現在，我認為展望未來，我們希望看到視力人口取得進一步進步，但我認為這不會是快速的成長。

I think we've already gotten to 40% NBRx share and that we'll need to get to steady gains by expanding further and further the number of treating sites for the vision population.

我認為我們的 NBRx 份額已經達到 40%，我們需要透過進一步擴大視力人群的治療站點數量來實現穩定的成長。

But it is possible certainly that the DTC will start to have an impact that we kicked off in quarter three of last year.

但 DTC 肯定有可能開始對我們去年第三季開始產生影響。

Usually, it takes six months for DTC to have an impact -- so it would be around February, March of this year, we might see some impact on the vision population.

通常，DTC 需要六個月才能產生影響 - 所以大概在今年二月、三月，我們可能會看到它對視力人群產生一些影響。

But really, our organizational focus is on the PSMA 4 launch.

但實際上，我們組織的重點是 PSMA 4 的發布。

I think now that we have a really compelling PFS data.

我認為現在我們有了真正令人信服的 PFS 數據。

We have very compelling data on distant mets.

我們擁有有關遠距離大都會的非常令人信服的數據。

We have now the OS unadjusted for crossover at 0.91, I think everything now is a good setup to go into a population that's 3 times larger, really ensure the sites that are already using Pluvicto now fully maximize their capacity to get as many patients to benefit from the therapy as possible and also accelerate our efforts to get even more sites ready in the community.

現在，我們的未調整交叉的OS 為0.91，我認為現在的一切都是一個很好的設置，可以進入3 倍大的人群，真正確保已經使用Pluvicto 的站點現在充分發揮其能力，讓盡可能多的患者受益盡可能遠離治療，並加快努力在社區中準備好更多的站點。

We've launched a number of initiatives.

我們已經發起了多項措施。

We're launching a few more over the course of the quarter to really simplify and hopefully get clinicians very comfortable even in the community oncology setting, providing radiopharmaceuticals or radioligand therapy.

我們將在本季推出更多技術，以真正簡化流程，並希望讓臨床醫生即使在社區腫瘤科環境中也能舒適地提供放射性藥物或放射性配體治療。

And that's where I think we're going to see the next uplift for the brand.

我認為，這就是我們將看到品牌下一次提升的地方。

Next question, operator?

下一個問題，接線生？

Matthew Weston, UBS.

瑞銀的馬修·韋斯頓（Matthew Weston）。

Thank you.

謝謝。

I don't know what happened earlier.

我不知道之前發生了什麼事。

It's a question for Harry.

這是給哈利的一個問題。

And it's again about guidance, Harry, but particularly about the impact of Medicare Part D reform on what you've assumed within your growth.

哈利，這又是關於指導的問題，特別是關於醫療保險 D 部分改革對你在成長過程中所假設的影響。

So one of the questions we've had a lot this morning from investors is how can you be so confident given that you have a very large oral oncology portfolio, which is assumed to be used largely in the Medicare Part D population.

所以今天早上投資者向我們提出的一個問題是，鑑於你們擁有非常龐大的口腔腫瘤學產品組合，而且這些產品被認為主要用於聯邦醫療保險 D 部分人群，你們怎麼能如此自信呢？

So what have you assumed in your outlook are the puts and takes around that portfolio from that new reform?

那麼，您認為新改革將為投資組合帶來哪些影響？

Yeah.

是的。

Thanks, Matthew.

謝謝，馬修。

I'll actually take that one.

我確實會選擇那個。

Overall, we expect a modest headwind from the Part D reforms, and we fully factored that into our guidance.

總體而言，我們預計 D 部分改革將帶來適度阻力，我們已將這一點充分考慮在我們的指導中。

The two brands where we see the biggest impact of the reforms, primarily paying into the -- to cover in the catastrophic phase or for Cosentyx and Kisqali.

我們看到改革對兩個品牌的影響最大，主要是為了支付災難階段的費用或用於 Cosentyx 和 Kisqali。

But overall, when we look at it, we've factored in the expected modeled headwinds from that.

但總體而言，當我們審視這個問題時，我們已經將預期的模型阻力納入考量。

We look at the potential volume uplift, which we don't really put a lot of stake in yet because we'd really like to see how that ultimately unfolds over the course of this year.

我們關注的是潛在的銷售成長，但我們目前還沒有投入太多精力，因為我們真的想看看今年銷售最終會如何發展。

And we see a modest headwind, which we think we can manage fully, and that's incorporated into our guidance.

我們看到了適度的逆風，我們認為我們可以完全應對，並將其納入我們的指導中。

.

。

I think we'll see.

我想我們會看到。

I mean I think in the midterm, the policy should lead to volume uplifts, more patients staying on therapy, which is why the industry wanted a 2,000 out-of-pocket cap and that would ultimately, of course, improve patient compliance, staying on their medicines and ultimately impact -- positively impact their sales in the coming years.

我的意思是，我認為在中期內，這項政策應該會導致治療量增加，讓更多患者繼續接受治療，這也是為什麼該行業希望自付費用上限為2,000，這最終當然會提高患者的依從性，讓他們繼續接受治療。

In this first year, I think it's hard to put much credence on that.

在這第一年，我認為很難相信這一點。

But beyond that, we feel very comfortable with the modeling that we did.

但除此之外，我們對所做的建模感到非常滿意。

We think we've taken appropriately conservative assumptions.

我們認為我們已經做出了適當保守的假設。

Thank you.

謝謝。

Richard Vosser, JPMorgan.

摩根大通的理查沃瑟。

Hi.

你好。

Thanks for taking my question.

感謝您回答我的問題。

Question on Kisqali.

關於 Kisqali 的問題。

Looking at the NBRx share in metastatic, it stayed at sort of 50% for a number of quarters and maybe a couple of years now.

從轉移性癌症的 NBRx 份額來看，在過去幾個季度甚至幾年裡，它一直保持在 50% 左右。

So I'm just wondering what it takes to change that.

所以我只是想知道要怎麼樣才能改變這種狀況。

You have a superior product.

你們的產品很優質。

Does the -- the sort of halo effect from the adjuvant allow you to get more accounts on board -- just can we see that displacement of [Ibrance], just your thoughts.

佐劑產生的光環效應是否能讓你獲得更多的帳戶——我們是否能看到 [Ibrance] 的位移，只是你的想法。

Yes.

是的。

Thanks, Richard.

謝謝，理查。

I think the Kisqali shares really started to gain in the first part of last year.

我認為 Kisqali 的股價在去年上半年確實開始上漲。

After we had the early breast cancer readout and led to a lot more confidence overall in the brand as well as the NCCN guidelines further supporting the use of Kisqali.

在我們獲得早期乳癌讀數後，對該品牌的整體信心大大增強，並且 NCCN 指南也進一步支持使用 Kisqali。

I think now we are hopeful that with the early breast cancer readout and the opportunity to have a single medicine for all patients within a clinic that we can drive the overall share NBRx share higher than 52%.

我認為現在我們有希望透過早期乳癌讀數和在診所內為所有患者提供單一藥物的機會將 NBRx 的整體份額提高到 52% 以上。

We do have a cap probably somewhere around 75%, 80% just because of some of the payer dynamics and some of the contraindications for Kisqali.

我們確實有一個上限，大約在 75% 到 80% 左右，這只是因為一些付款人的動態和 Kisqali 的一些禁忌症。

But of course, our goal is to get from that 52% as high as we can to that 75% over the coming years.

但當然，我們的目標是在未來幾年內盡可能將這一比例從 52% 提高到 75%。

Of course, we have plenty of time now to do that.

當然，我們現在有充足的時間來做這件事。

And I think we should see steady gains over time on that one.

我認為隨著時間的推移，我們應該會看到穩定的成長。

But the biggest focus for us right now is maximizing the opportunity in the node 0 and Node 1 patients without risk factors where Kisqali is uniquely labeled, and our competitors are not.

但目前我們最大的關注點是最大限度地利用沒有風險因素的節點 0 和節點 1 患者的機會，因為 Kisqali 具有獨特的標籤，而我們的競爭對手則沒有。

And our ability to get those patients diagnosed and then ultimately on therapy, it's such a sizable population and the size of -- obviously, the public health benefit we can deliver, that's the core focus for us overall.

我們有能力讓這些患者得到診斷，然後最終接受治療，因為這是一個龐大的群體，而且顯然我們可以提供的公共衛生福利的規模，這是我們總體上關注的核心。

And then with that, of course, we should see metastatic gains as well.

當然，我們也應該看到轉移性的進展。

Cool.

涼爽的。

Thanks.

謝謝。

Graham Parry, Bank of America.

美國銀行的格雷厄姆·帕里。

Great.

偉大的。

Thanks for taking my question.

感謝您回答我的問題。

It's just on Entresto, just wanting to get perhaps a little bit more detail on the dynamics that are factored into the guidance for 2025.

這只是關於 Entresto 的問題，只是想獲得關於 2025 年指導中考慮到的動態的更多細節。

So what sales progression are you looking at worldwide and in the US.

那麼您看到全球和美國的銷售成長情況如何？

And in the US GCA benefit in the first half of the year from donut hole discount removal?

那麼，美國上半年的 GCA 收益是否因取消甜甜圈折扣而增加？

And to what extent does that offset some of the generic decline you should get in the second half of the year.

這在多大程度上可以抵消今年下半年可能出現的一些普遍下滑？

And on generics, how confident you can hold off Entresto Genex until 16th of July, and the court filings suggest MSN is trying every which way to launch at the moment and there's only one appeal court stay in place, blocking them from doing that?

關於仿製藥，您有多大把握將 Entresto Genex 推遲到 7 月 16 日，而法庭文件表明 MSN 目前正在想盡一切辦法推出該藥物，但只有一個上訴法院的禁令阻止他們這樣做？

And are you confident they haven't shipped any product at all in that narrow window there wasn't actually stay in place a couple of weeks ago.

您是否確信他們在幾週前那個狹窄的時間內沒有運送任何產品？

Thank you.

謝謝。

Yes.

是的。

Thanks, Graham.

謝謝，格雷厄姆。

On the overall dynamics, Harry.

就整體動態而言，哈利。

Yes, overall, we would expect continued good growth of Entresto until from a forecast assumption standpoint, middle of the year.

是的，總體而言，從預測假設的角度來看，我們預計 Entresto 將持續保持良好的成長直到今年年中。

Of course, our colleagues in the legal and IP department will do everything to appropriately defend further patents, but that's for now the financial forecast assumption.

當然，我們法律和智慧財產權部門的同事將竭盡全力適當地捍衛進一步的專利，但這只是目前的財務預測假設。

And so we would see growth on that.

因此我們會看到這方面的成長。

And yes, you are right, there is some favorability from the Medicare Part D design on Entresto as it is not a very high-priced specialty product.

是的，您說得對，由於 Entresto 不是價格很高的專業產品，因此 Medicare Part D 設計對 Entresto 有一定的偏好。

So very positive dynamics expected until LOE would happen in the US.

因此，在美國發生 LOE 之前，預計會出現非常積極的動態。

And then, of course, what -- actually, when we look at the multiyear outlook and forecast, Entresto is one of the products that's really under-forecasted versus our model from the consensus due to the fact that Europe, at least end of '26, Japan 2030.

然後，當然，實際上，當我們查看多年的展望和預測時，Entresto 是與我們的共識模型相比真正被低估的產品之一，這是因為歐洲至少在年底之前26、日本2030。

And then we have a large tail end product over a large -- even small molecules in emerging markets.

我們在新興市場中擁有大量的大分子甚至小分子的尾端產品。

So also there quite a lot of, let's say, remainder of sales because of Japan should be a blockbuster and then emerging markets once even end of '26 Europe would see generic entries.

因此，可以說，剩餘的銷售額相當大，因為日本應該是一部轟動性的影片，然後是新興市場，甚至在 26 年底，歐洲也會出現仿製藥。

Thanks, Harry.

謝謝，哈利。

And of course, we're pursuing all options in Europe and Japan to ensure we maximize the exclusivity for Entresto in those geographies, and there are certainly options that might materialize.

當然，我們正在歐洲和日本尋求所有的選擇，以確保在這些地區最大限度地提高 Entresto 的獨佔性，而且肯定有一些選擇可能會實現。

Now, I think on the US dynamic to our knowledge and our best understanding, there were no products shipped into the channel in those few hours.

現在，我認為，就我們所知和所理解的美國動態而言，這幾個小時內沒有任何產品運入管道。

The stay is in place.

暫緩執行。

MSN has requested a reconsideration of the Circuit Court's stay.

MSN 已請求巡迴法院重新考慮該暫緩執行的決定。

And of course, we'll monitor that situation, but we believe it's very clear that the spirit of the law very much is that we did our pediatric exclusivity studies and those pediatric -- that pediatric 6-month extension on the combination pattern, which has been upheld should be respected.

當然，我們會密切關注這一情況，但我們認為，法律的精神很明顯，我們進行了兒科獨佔性研究，以及兒科——兒科組合模式的 6 個月延長，這已經堅持的，就應該得到尊重。

And so that's our very clear position.

這就是我們的非常明確的立場。

We, of course, continue to litigate out the amorphous complex patents as well as the lawsuit that we have that the FDA should not have approved products with a carve-out on the dosing regimen on the label.

當然，我們會繼續對無定形複合物專利進行訴訟，並繼續認為 FDA 不應該批准標籤上對給藥方案有豁免的產品。

So those court cases also continue to go on over the course of these months.

因此這些法庭案件在這幾個月也將繼續審理。

And we'll see how it unfolds.

我們將拭目以待事情將如何發展。

Our best estimate at the moment is to give you that forecasting guidance of middle of the year.

目前，我們最好的估計是給您提供年中的預測指引。

And if anything changes, either we or I think IPD will let you know probably IPD sooner than us, but we do the best we can.

如果有任何變化，我們或我認為 IPD 可能會比我們更早通知您，但我們會盡力而為。

So thank you very much.

非常感謝。

Etzer Darout, BMO Capital Markets.

Etzer Darout，BMO資本市場。

Great.

偉大的。

Thanks for taking the question.

感謝您回答這個問題。

I had a couple of inbound this morning.

我今天早上有幾趟來往。

Just wondering if you had any maybe additional commentary you could provide on the push out of the Horizon Phase 3 and maybe what could be driving that the event sort of rate dynamic relative to your initial event rate assumptions?

只是想知道您是否可以對 Horizo​​​​n Phase 3 的推出提供任何額外的評論，以及相對於您最初的事件發生率假設，是什麼因素推動了這種事件發生率的動態變化？

Thank you.

謝謝。

Yes.

是的。

Thanks, Etzer.

謝謝，Etzer。

So this is an event-driven study.

所以這是一項事件驅動的研究。

We've been modeling the event rates.

我們一直在對事件發生率進行建模。

I think I've also heard a few questions.

我想我也聽到了幾個問題。

There's been no interim analysis of -- no interim analysis drove this.

尚未進行中期分析——沒有中期分析推動這一點。

This is just event rate modeling on the blinded event rates that we saw, and we expect now to reach the final number of events, which is, I think, always preferable for a cardiovascular study that we need to ensure is adequately powered in the first part of next year.

這只是根據我們看到的盲法事件發生率進行事件發生率建模，我們現在預計會達到最終的事件數量，我認為，這對於心血管研究來說總是更好的，我們需要確保在第一次就獲得足夠的支持明年的一部分。

We don't have a good unnecessarily guess.

我們沒有不必要的猜測。

I mean, in general, I would say cardiovascular outcome studies have been trending to lower event rates under time over time.

我的意思是，總的來說，我認為心血管結果研究一直趨向於隨著時間的推移而降低事件發生率。

It's important to note that in these studies, we very rigorously ensure that all patients are at their appropriate treatment levels for LDL lowering to ensure that we can isolate the impact as FDA assets of the LDL lowering therapy.

值得注意的是，在這些研究中，我們非常嚴格地確保所有患者都處於適當的降低 LDL 治療水平，以確保我們能夠將 LDL 降低治療的影響分離為 FDA 資產。

So quite -- it could be the background rate.

所以相當合理——它可能是背景利率。

It could be -- the drug is working.

有可能——藥物正在發揮作用。

That's always our hope, but we can't be sure of that as well.

這一直是我們的希望，但我們也不能確定。

So we'll see over the course of -- we'll see next year at the end, how the study reads out.

因此，我們將在明年年底看到這項研究的結果。

But we remain very confident that the drug is doing what it's supposed to do.

但我們仍然非常有信心，這種藥物正在發揮其應有的作用。

Mechanism of action is clear.

作用機轉明確。

When we look at the profile of the patients that we enrolled, this is the high-risk patient population we wanted to enroll high levels of [LDL], but then with the lowering that we are seeing -- that we expect to see that, that should lead to the cardiovascular risk reduction that we hoped for.

當我們查看招募的患者概況時，我們發現這是高風險患者群體，我們希望招募高水平的 [LDL]，但隨著我們看到的降低——我們預計會看到，這應該可以達到我們所希望的降低心血管風險的效果。

So that's the best guidance I can give you at this point in time.

所以這是我目前能給你的最好的指導。

Great.

偉大的。

Thank you.

謝謝。

I appreciate the color.

我很欣賞這個顏色。

James Quigley, Goldman Sachs.

高盛的詹姆斯·奎格利（James Quigley）。

Great.

偉大的。

Thanks for taking my questions.

感謝您回答我的問題。

Going on the guidance, unfortunately.

不幸的是，按照指導去做。

Harry, would you be able to sort of split the guidance out between volumes, generic impact and pricing, presumably, pricing is close to 0 or slightly negative.

哈利，你能否將指導方針分為銷售、一般影響和定價，大概定價接近 0 或略微為負。

But super helpful if you could give us an idea of how that breaks down?

但如果您能告訴我們這是如何分解的，那將非常有幫助嗎？

And then secondly, on the slide, where you break out the half one versus half two, obviously, the second half takes a hit because of generics.

其次，在投影片上，如果你將第一部分與第二部分進行比較，顯然，第二部分會因為仿製藥而受到打擊。

Where would that land if you didn't have the generic impact and is low to mid-single digits, say, a sort of sensible exit rate for the second half of your guidance out to the end of 2029.

如果沒有一般影響，而且退出率處於低至中等個位數，那麼到 2029 年底，您的指導目標的後半段會達到什麼樣的水平？

I appreciate that you don't guide on the individual years, but just some color would be useful.

我很欣賞您沒有針對個別年份進行指導，但提供一些顏色會很有用。

Yes.

是的。

Thanks, James.

謝謝，詹姆斯。

Harry?

哈利？

Yes.

是的。

Okay.

好的。

So let's give a try.

那我們就來試試吧。

So overall, we expect continued, if not slightly increased volume growth due to our launches and continued very good execution from a volume standpoint, right?

因此總體而言，由於我們的產品發布以及從銷售角度來看持續非常好的執行，我們預計銷量將繼續成長，甚至略有增加，對嗎？

Pricing probably will be a little bit more pressure.

定價可能會帶來更多壓力。

Usually, we have on a year like 1% to 2% points negative.

通常，我們一年的利潤率為負 1% 到 2%。

Last year, in '24, we had flat, but there's a little bit of growth to net pressure was due to Medicare point redesign, but nothing dramatic there.

去年，即 24 年，我們的收入持平，但淨壓力略有增長，這是由於醫療保險積分重新設計造成的，但沒有什麼戲劇性的。

And the key impact will be an increased generic according to these forecast assumptions.

根據這些預測假設，關鍵影響將是通用藥物的增加。

Now, for the US, we have taken simply analogs for small molecules in the different categories, cardiovascular as well as onco.

現在，對於美國，我們已經採取了不同類別（心血管和腫瘤）小分子的簡單類似物。

And that's what you can model yourself.

這正是您可以模仿的。

Now, if these three would not happen, I would expect the first half to look like the second half.

現在，如果這三件事沒有發生，我預計上半場將會和下半場一樣。

Unfortunately, there is not an unreasonable assumption, that will happen.

不幸的是，沒有任何不合理的假設，那將會發生。

So that's why we carefully have modeled this.

這就是我們仔細建模的原因。

Thank you.

謝謝。

Seamus Fernandez, Guggenheim Securities.

古根漢證券公司的謝默斯‧費爾南德斯 (Seamus Fernandez)。

Great.

偉大的。

Thanks for the question.

謝謝你的提問。

So my question is on imalumab.

我的問題是關於 imalumab 的。

You guys have Sjögren's data coming this year in my understanding as well as some additional Phase 2 and 3 data sets.

據我所知，你們今年有乾燥症的數據以及一些額外的第 2 階段和第 3 階段的數據集。

Where are you most excited about the opportunity for ianalumab, it would strike me that Sjogren's is the highest unmet medical need where even just a positive study would gain substantial utilization.

您對 ianalumab 的機會最為興奮的是什麼？ 我認為乾燥症是未滿足的醫療需求最高的疾病，即使只是進行積極的研究也能獲得廣泛的利用。

Just trying to get a better understanding of how you're thinking about the market opportunity in Sjogren's and then more broadly for ianalumab.

只是想更了解您如何看待乾燥症的市場機會，以及更廣泛地說，ianalumab 的市場機會。

Thanks so much.

非常感謝。

Yes.

是的。

Thanks, Seamus.

謝謝，西莫斯。

We are very excited about ianalumab's potential, both in hematology and in immunology.

我們對 ianalumab 在血液學和免疫學領域的潛力感到非常興奮。

So in immunology, clearly, the Sjogren's will be the first key foundational readout.

因此，在免疫學中，乾燥症顯然將是第一個關鍵的基礎讀數。

We're studying it in the roughly 40% of patients who have systemic manifestations of Sjogren's disease.

我們正在對大約 40% 患有乾燥症全身表現的患者進行研究。

In the Phase 2b study, we demonstrated, for the first time, significant improvements in the SDI, which is focused on the systemic manifestations, including improvements in areas such as fatigue and other physician assessed parameters.

在第 2b 階段研究中，我們首次證明了 SDI 的顯著改善，該改善側重於全身表現，包括疲勞和其他醫生評估參數等領域的改善。

And so if we can get a positive read, we'll try to get as broad a label as we can.

因此，如果我們能夠獲得積極的解讀，我們將嘗試獲得盡可能廣泛的標籤。

And we're also assessing should we also study the medicine over time in those patients, the remaining 60% of patients, a subset of them who primarily have symptom manifestations without the systemic manifestations.

我們也正在評估是否應該對這些患者（剩餘 60％ 的患者）進行長期藥物研究，這部分患者主要表現為症狀，而沒有全身表現。

So I think there's significant opportunity in HS.

所以我認為 HS 中存在著重大機會。

Then, of course, following up on that, we have the systemic lupus and lupus nephritis studies as well running and as well as you note, the Phase 2b in hydrodenitis.

當然，在此基礎上，我們也進行了系統性紅斑狼瘡和狼瘡性腎炎研究，以及您所提及的積水炎的 2b 期研究。

Alongside that, I think while there is reasonable standards of care in idiopathic thrombocytopenic purpura, ITP, this medicine also has the potential with its mechanism to be an improvement in second line and first-line ITP and that we also have a readout in 2025 as well.

除此之外，我認為，雖然特發性血小板減少性紫斑症(ITP) 的治療標準合理，但這種藥物也有可能透過其機製成為二線和一線ITP 的改善藥物，而且我們也將在2025 年看到結果出色地。

And so that would obviously enable us to start the process in hematology.

因此這顯然使我們能夠開始血液學研究過程。

We have worked through ensuring we have a different dose levels as well so we can manage the different indications in immunology and hematology from a price standpoint.

我們努力確保擁有不同的劑量水平，以便從價格的角度管理免疫學和血液學的不同適應症。

So taken together, I mean, you have six Phase 3 studies across the board already running frianilumab, multiple Phase 2s.

所以綜合起來，我的意思是，目前已經有六項 3 期研究正在全面運行 frianilumab，還有多項 2 期研究。

So assuming they go our way, this could be a very significant medicine, probably underappreciated overall.

因此，假設他們按照我們的意願行事，這可能是一種非常重要的藥物，但總體上可能被低估了。

Naresh Chouhan, Intron Health.

Naresh Chouhan，Intron Health。

Hi, there.

你好呀。

Thanks for taking my questions.

感謝您回答我的問題。

Just one on OAV, please.

只需一個 OAV 即可。

So the consensus currently modeling very little, if anything at all for OAV101.

因此，目前對於 OAV101 的共識建模非常少，甚至根本沒有。

Can you help us think through the bolus opportunity and the speed of ramp up?

您能幫助我們思考推注機會和加速速度嗎？

We think it could be a blockbuster by 2027.

我們認為到 2027 年它可能會成為一部賣座影片。

Is that unreasonable?

這不合理嗎？

And how do you think about the speed of ramp-up.

您如何看待成長速度？

Thanks.

謝謝。

Yes.

是的。

I think -- ones, it's obviously early days from our standpoint.

我認為—從我們的角度來看，現在顯然還為時過早。

But certainly, with -- I can use the analog of what we saw with Zolgensma.

但可以肯定的是，我可以使用我們在 Zolgensma 中看到的情況進行類比。

And certainly, in that case, we did see a very fast ramp.

當然，在那種情況下，我們確實看到了非常快速的上升。

And then to the steady state and then we stayed at that steady state.

然後達到穩定狀態並且我們保持在該穩定狀態。

I think it was two, three years until we got to the steady state.

我認為我們花了兩三年的時間才達到穩定狀態。

And that's generally what we would expect, I think, in the case of gene therapies.

我認為，就基因治療而言，這通常正是我們所期望的。

And so I think we'll see with OAV, the dynamic is obviously a little bit different because many of these patients will need to be switched patients.

因此我認為我們會看到 OAV 的動態顯然有些不同，因為其中許多患者將需要更換患者。

But I think when you look at the competitive set that we're going up against.

但我認為，當你看看我們所面臨的競爭對手。

You have a competitor that requires quarterly intrathecal administrations into the spinal cord, which is quite challenging for patients over time.

您的競爭對手要求每季進行脊髓鞘內注射藥物，這對於患者的長期治療來說是相當具有挑戰性的。

And also, patients often have malformations and the deformities that happened in the spine as a result of the repeated injections.

而且患者常會因為反覆注射而出現脊椎畸形和變形。

And then the other competitor of medicine was not tested with the standard of care Hammersmith score, which is the gold standard, which is what we used.

然後，其他醫學競爭對手並沒有接受護理標準哈默史密斯評分（即黃金標準，也是我們所採用的）的測試。

And I think our hope is by going to the physician and patient population saying, look, you have a onetime gene therapy using the gold standard Hammersmith score demonstrating statistically significant improvement using that score with a very expected safety profile that could be very compelling for a large number of patients.

我認為我們的希望是，透過向醫生和患者群體說，看，你有一個使用黃金標準漢默史密斯評分的一次性基因治療，使用該評分顯示出統計學上顯著的改善，並且具有非常預期的安全性，這對於一個非常有吸引力的大量的患者。

That's the approach we're going to take in rolling the medicine out and I'm hopeful that it will surprise people as well because I think there is the opportunity as we guided, this could be overall a $3 billion-plus medicine over time.

這就是我們推出這款藥物的方法，我希望它也會讓人們感到驚訝，因為我認為，按照我們的指導，這款藥物的總價值可能隨著時間的推移達到 30 億美元以上。

And that's very much the goal.

這正是我們的目標。

And I think also, of course, with gene therapies, we have the opportunity to have medicines that are -- don't -- at least our current understanding, be difficult to face real generic erosion.

當然，我還認為，有了基因療法，我們就有機會獲得難以應對真正仿製藥侵蝕的藥物——至少根據我們目前的理解。

So these become medicines that kind of stay in the long run in our portfolio.

因此，這些藥物將長期保留在我們的產品組合中。

Eric Le Berrigaud, Stifel.

艾瑞克·勒貝里戈（Eric Le Berrigaud），Stifel。

Yes.

是的。

Hi.

你好。

Again, on guidance, but this time on the midterm guidance and trying to put the '25 guidance in the context of midterm guidance.

再次，關於指導，但這次是關於中期指導，並嘗試將'25 指導置於中期指導的背景下。

Since you implemented this midterm guidance, you systematically beat and raise. '23 was much higher, '24 was much higher.

自從你實施了這個中期指導方針以來，你就係統地擊敗了對手並獲得了提升。 '23 高得多，'24 高得多。

And then we thought that maybe the transition with the significant LOEs in '25, '26 would be the reason for the midterm guidance to be lower than what you achieved.

然後我們認為，也許 25 年和 26 年重大 LOE 的轉變可能是導致中期指導低於您所實現的目標的原因。

But now in '25, you're guiding for mid- to high single digit, which is again higher than the midterm guidance.

但現在，在 25 年，你的指導價格是中高個位數，這又高於中期指導價格。

And so, if we think that '26 will very much look like '25 because it's a 50-50, mid '25, mid '26 impact.

因此，如果我們認為 26 年與 25 年非常相似，因為 2025 年中期和 2026 年中期的影響是 50-50。

And then '27, '28 should see some rebound with no significant LOE.

然後 27 年、28 年應該會出現一些反彈，但不會出現明顯的 LOE。

It becomes hard to understand why the midterm guidance is not more, let's say, higher or, let's say, to articulate things.

很難理解為什麼中期指導沒有更高水平，或者更清楚地表達事情。

So maybe something is missing, but could you put that in some context or just the global policy of underpromise and overdeliver.

所以也許有些東西缺失了，但你能否將其放在某種背景下，或者只是少承諾、多兌現的全球政策。

Thank you.

謝謝。

No, certainly not a global policy.

不，當然不是一項全球政策。

We do our best to give you the midpoint estimate of where we think things will go.

我們會盡力為您提供我們認為事情發展走向的中間估計。

And then, of course, if we do better, and over the last 2 years, I think our performance -- operating performance has been outstanding.

當然，如果我們做得更好，在過去的兩年裡，我認為我們的表現——營運表現一直很出色。

I see 2-plus years now.

我現在已經看到兩年多了。

And I think that's part of the reason you've seen the consistent beats and raises.

我認為這就是您看到持續節拍和加薪的原因之一。

I think certainly, over the coming years, we'll see.

我想，在未來幾年裡，我們一定會看到。

I mean, we, of course, will update over time.

我的意思是，我們當然會隨著時間的推移而更新。

I mean the 2026, we have the full year impact, of course, of these generic entries.

我的意思是，到 2026 年，我們當然會受到這些通用條目全年影響。

And then we'll clear them and then accelerate growth from there.

然後我們會清除它們，並從那裡加速成長。

So I don't think we're in a position at this moment to change our midterm guidance.

因此我認為我們目前還不能改變我們的中期指導。

But obviously, if we consistently perform at a higher level than the 5% midterm guidance, we'd have to reconsider it.

但顯然，如果我們的表現持續高於 5% 的中期指導水平，我們就必須重新考慮。

But I think right now, our focus is delivering 2025 per plan, getting these launches up on the trajectory, closing the current gap that consensus has to our view, which I think is roughly 2 points '24 to '29.

但我認為現在我們的重點是按照計劃在2025 年實現這些目標，讓這些發射按照計劃進行，縮小目前共識與我們觀點之間的差距，我認為這個差距大約是2024 年至2029 年的2 個百分點。

So I think, Eric, you're there, but some of your colleagues are not.

所以我想，埃里克，你在那裡，但你的一些同事不在。

And so I think that getting that gap closed by showing confidence in Kisqali, in Leqvio, in Pluvicto, in Scemblix, in Fabhalta with the remibrutinib launch with some of the pipeline delivery, continuing delivering on Cosentyx -- and then, of course, we'll reconsider the midterm outlook as appropriate.

因此，我認為，透過展示對 Kisqali、Leqvio、Pluvicto、Scemblix 和 Fabhalta 的信心，以及 remibrutinib 的推出和部分產品線的交付，以及繼續交付 Cosentyx，可以縮小這一差距——當然，我們將會酌情重新考慮中期前景。

(Operator Instructions) Richard Parkes, BNP Paribas.

（操作員指示）理查德·帕克斯，法國巴黎銀行。

Hi.

你好。

Thanks for taking my follow-up.

感謝您關注我的後續問題。

It's just on Cosentyx, the competitive environment.

這只是關於 Cosentyx 的競爭環境。

We've now had Benzalex on the market for a year or so.

現在 Benzalex 已經上市一年左右了。

And I believe that has some recent formulary wins and obviously launching in the HS indication.

我相信這在最近獲得了一些處方集的勝利，並且顯然在 HS 適應症中得到了推廣。

So just wondering how that competitive environment is playing out and what you anticipate in your guidance?

所以只是想知道競爭環境是如何發展的以及您在指導中預期什麼？

And maybe if you could quantify the opportunity for Cosentyx and the new indications that you outlined, GCA and PMR.

也許您可以量化 Cosentyx 的機會以及您概述的新適應症 GCA 和 PMR。

And then finally, I'd like to thank you for the [LP] test at your management day because given it was minus borderline, I've now started on a statin.

最後，我要感謝您在管理日進行的 [LP] 測試，因為考慮到它是負邊界，我現在已經開始服用他汀類藥物。

So I appreciate the opportunity.

我很感激有這個機會。

That's great to hear, Richard.

很高興聽到這個消息，理查德。

I'm glad we could help.

我很高興我們能幫忙。

On Cosentyx, we had 25% growth this year.

Cosentyx 今年的成長率為 25%。

So I think that shows the robust growth profile of the brand.

所以我認為這體現了該品牌強勁的成長勢頭。

In terms of the competitor entries, when you look at our formulary position, it's as we expect, we've had to give the appropriate level of adjustments on our rebates, but we've maintained very good formulary position.

就競爭對手的參賽作品而言，當您查看我們的配方位置時，它正如我們預期的那樣，我們必須對我們的回扣進行適當的調整，但我們保持了非常好的配方位置。

We see very good performance in Asian markets such as China as well as continued good performance in Europe.

我們看到中國等亞洲市場表現非常好，歐洲市場也持續表現良好。

In Asia specifically, we think our profile of having very good flare resolution where we showed very compelling data on flare, on pain, I think on itch on some of these, I think this really gives us a very compelling data set.

特別是在亞洲，我們認為我們的概況具有非常好的耀斑分辨率，我們展示了關於耀斑、疼痛、瘙癢等方面的非常有說服力的數據，我認為這確實為我們提供了非常有說服力的數據集。

And given the long history of safety with Cosentyx, we think a very competitive profile to hopefully maintain that 60% plus NBRx that we have.

鑑於 Cosentyx 的長期安全歷史，我們認為其非常有競爭力，預計將維持 60% 以上的 NBRx。

We believe in HS, Cosentyx to be over $1 billion medicine globally.

我們相信 HS、Cosentyx 將成為全球價值超過 10 億美元的藥物。

Now, for GCA and PMR, our current estimates are $500 million plus for each one of these.

現在，對於 GCA 和 PMR，我們目前的估計是每個項目需要 5 億多美元。

I think the question, of course, we'll have to see.

我認為，當然，我們必須看到這個問題。

I think originally for HS, we thought this would be $500 million to $750 million, and we delivered that almost in the first year.

我認為最初對於 HS 來說，我們認為這將是 5 億到 7.5 億美元，而且我們幾乎在第一年就實現了這一目標。

So I think we're learning as we go as we get into these new indications.

所以我認為，我們在探索這些新跡象時是邊學習邊做的。

And as we have a better sense from launching of, of course, positive data and then launching, we can, of course, update over time.

當然，隨著我們對發布的積極數據以及隨後發布的產品有了更好的了解，我們當然可以隨著時間的推移進行更新。

Thank you.

謝謝。

Florent Cespedes, Bernstein.

弗洛朗·塞斯佩德斯、伯恩斯坦。

Good afternoon, again.

再次下午好。

Thank you for taking my follow-up question.

感謝您回答我的後續問題。

This time, not on guidance, but on the pipeline for US, as pelacarsen is now expected in 2026, and it was supposed to be the big Phase 3 readout.

這次，不是關於指導，而是關於美國的管道，因為 pelacarsen 現在預計在 2026 年投入使用，而且它應該是第 3 階段的重大讀數。

Now, on the list of the products that will read out this year, that would be the Phase 3.

現在，在今年將要推出的產品清單上，這將是第三階段。

Please, could you share with us, which is, or which are the most meaningful one, please?

請您與我們分享哪一個或哪些是最有意義的？

Yes, absolutely, Florent.

是的，當然，弗洛朗。

So I think there's a couple of things I'd say.

所以我想我有幾件事要說。

First, ianalumab is a key readout.

首先，ianalumab 是一個關鍵的讀數。

And I think we've already highlighted that both Sjogren's and second line ITP, both of these will be, I think, really important for the profile and opportunity in ianilumab and also hopefully give a read-through of what we might be able to do in lupus, in lupus nephritis in a frontline ITP amongst others.

我認為我們已經強調過，乾燥症和二線 ITP 都對 Ianilumab 的概況和機會非常重要，也希望能夠讓人們了解我們可能做的事情在狼瘡、狼瘡性腎炎以及一線 ITP 等疾病中均有應用。

In addition, we're going to have the readout of Pluvicto in hormone-sensitive prostate cancer, which will further create a patient population that's as large as the vision -- sorry, the PSM4 population.

此外，我們將對 Pluvicto 在荷爾蒙敏感性前列腺癌中的表現進行讀數，這將進一步創建一個與願景一樣大的患者群體——抱歉，是 PSM4 群體。

And I think that would be another leg to build Pluvicto out to that guidance that we've given of $6 billion plus over time.

我認為這將是推動 Pluvicto 實現我們給予的 60 億美元以上長期目標的另一個支柱。

In addition, you're going to have, I think, importantly, the remibrutinib food allergy Phase 2b readout, which will then enable us to move rapidly for the next third indication.

此外，我認為，重要的是，您將獲得瑞布替尼食物過敏 2b 期讀數，這將使我們能夠迅速採取行動進行下一個第三個適應症。

We hope remibrutinib on top of CSU and CINDU.

我們希望瑞布替尼能夠超越 CSU 和 CINDU。

I would say for remibrutinib, we expect to file soon and then we do currently intend to use a priority review voucher.

我想說，對於瑞布替尼，我們希望很快提交申請，然後我們目前打算使用優先審查憑證。

And we do believe that remibrutinib in CSU is going to be bigger than the markets expect.

我們確實相信，瑞布替尼在科羅拉多州立大學的銷售將超出市場的預期。

And I think the opportunity here in the US and around the world have an oral medicine that can address such a symptomatic disease within two weeks of therapy is something we're quite excited about.

我認為，在美國和世界各地有機會開發一種口服藥物，可以在治療兩週內治療這種症狀性疾病，這是我們感到非常興奮的事情。

So we're very much focused on that launch as well.

因此我們也非常關注這次發布。

And then, of course, on slide 33, you see a long list of other things.

然後，當然，在第 33 張投影片上，您會看到一長串其他內容。

But I think those would be the big ones. that I would highlight that would really move the needle for this year.

但我認為那些才是最重要的。我想強調的是，這將真正推動今年的發展。

Okay.

好的。

Thank you very much.

非常感謝。

I think that's it.

我認為就是這樣。

So thank you all very much for joining.

非常感謝大家的加入。

We look forward to seeing you in various settings over the course of the coming quarter and then again at the Q1 earnings call.

我們期待在下個季度的各種場合見到您，並在第一季財報電話會議上再次見到您。

Have a great day.

祝你有美好的一天。

Thank you.

謝謝。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for participating.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。