Biogen Inc (BIIB) 2025 Q1 法說會逐字稿

Good morning. My name is Melinda, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Biogen first quarter 2025 earnings call and business update. (Operator Instructions). Today's conference is being recorded. Thank you.

早安.我叫梅琳達，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Biogen 2025 年第一季財報電話會議和業務更新。（操作員指令）。今天的會議正在錄製中。謝謝。

I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

現在，我想將會議交給投資者關係主管 Tim Power 先生。鮑爾先生，您可以開始您的會議了。

Thanks, Melinda. Good morning, and welcome to Biogen's first quarter 2025 earnings call. During this call, we'll make forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review.

謝謝，梅琳達。早上好，歡迎參加 Biogen 2025 年第一季財報電話會議。在本次電話會議中，我們將做出前瞻性陳述，其中涉及風險和不確定性，可能導致實際結果與我們的前瞻性陳述有重大差異。我們在提交給美國證券交易委員會的文件中提供了一份全面的風險因素清單，我鼓勵您仔細閱讀。

Our earnings release and other documents related to our results as well as reconciliations between GAAP and non-GAAP results discussed on this call can be found in the Investors section of biogen.com. We've also posted the slides to our website that we'll be using during the call.

我們的收益報告和與我們的業績相關的其他文件以及本次電話會議上討論的 GAAP 和非 GAAP 業績之間的對帳可以在 biogen.com 的投資者部分找到。我們還將會議期間將使用的幻燈片發佈到了我們的網站上。

On today's call, I'll be joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, our Head of Development; and Robin Kramer, our Chief Financial Officer. We'll make some opening comments, and then we'll move to the Q&A session. (Event Instructions)

在今天的電話會議上，我們的總裁兼執行長 Chris Viehbacher 將與我一起參加；我們的開發主管 Priya Singhal 博士；以及我們的財務長 Robin Kramer。我們將發表一些開場白，然後進入問答環節。（活動須知）

I'll now turn the call over to Chris.

我現在將電話轉給克里斯。

Thank you, Tim. Good morning, everybody. Maybe first, a warm welcome to Robin. This is your first quarter as CFO of Biogen, Robin.

謝謝你，提姆。大家早安。首先，熱烈歡迎羅賓。羅賓，這是您擔任 Biogen 財務長的第一個季度。

So we had a very good start to the year, a strong quarter. Biogen is really a tale of two companies, in my view. There's one company which has been an MS company, and that portfolio, as you all know, has been gradually declining.

因此，我們今年的開局非常好，本季表現強勁。在我看來，Biogen 其實就是兩家公司的故事。有一家公司是微軟旗下的公司，眾所周知，該公司的投資組合一直在逐漸減少。

But there's a new bird, Biogen emerging. And when I look at the rare disease business in AD, ZURZUVAE and LEQEMBI and VUMERITY, we actually have a commercial portfolio that we're actively promoting that's now gotten to be about 45% of our product revenue. And those products mostly have a very long runway to continue to grow.

但有一種新鳥——Biogen——正在出現。當我看到 AD、ZURZUVAE、LEQEMBI 和 VUMERITY 的罕見疾病業務時，我們實際上有一個正在積極推廣的商業組合，現在它已占我們產品收入的 45% 左右。這些產品大多具有很長的成長空間。

And so we've been talking about it for a few years, but I think now this is actually starting to become visible. We're rolling these products out worldwide. We had the approval of LEQEMBI in Europe, for example, which is very important approval for us. But we've also seen the approval of SKYCLARYS in the UK and Brazil.

我們已經討論了幾年，但我認為現在這個問題才真正開始顯現出來。我們正在向全球推出這些產品。例如，我們獲得了歐洲 LEQEMBI 的批准，這對我們來說是非常重要的批准。但我們也看到 SKYCLARYS 在英國和巴西獲得了批准。

Of course, the next lever of growth is going to be our pipeline. And there, we're very happy to get the FDA Fast Track designation for our ASO targeting BIIB080. That's remarkable since that we haven't actually even read out Phase II yet, and I think is a sign of confidence in the importance of this potential new medicine in treatment of Alzheimer's. And of course, we've initiated the Phase III TRANSCEND study for felzartamab in AMR.

當然，下一個成長槓桿將是我們的管道。我們很高興針對 BIIB080 的 ASO 獲得了 FDA 快速通道認證。這很了不起，因為我們實際上甚至還沒有讀出第二階段的結果，我認為這表明了我們對這種潛在新藥在治療阿茲海默症方面的重要性的信心。當然，我們已經啟動了針對 AMR 的 felzartamab 的 III 期 TRANSCEND 研究。

And of course, we've always said we've got a very strong balance sheet. We're going to continue to patiently and in a disciplined way, augment the pipeline through external innovation. And we're very happy about the partnership that we built with -- on Zorevunersen in Dravet syndrome with Stoke. That's going to be an important medicine. We have that for the territories outside the United States.

當然，我們一直說我們擁有非常強勁的資產負債表。我們將繼續耐心且有紀律地透過外部創新來擴充管道。我們很高興與 Zorevunersen 建立了合作夥伴關係，共同研究斯托克的 Dravet 症候群。這將是一種重要的藥物。對於美國境外的領土，我們也有這樣的政策。

Now if we turn to where we are on these new product launches. So LEQEMBI, I mean, look at that, $96 million, that's almost $100 million. Now we're into serious product territory. We have, as I said, obtained the marketing authorization in the EU. And it's important not just because of the market potential in the EU. But now we can say that this is a drug that has been recognized for its importance, its efficacy, its safety profile by all major regulators in the world. And that's an important sign of confidence.

現在我們來看看這些新產品的發布情況。所以 LEQEMBI，我的意思是，看看這個，9600 萬美元，差不多是 1 億美元。現在我們進入了嚴肅的產品領域。正如我所說，我們已經獲得了歐盟的營銷授權。它的重要性不僅在於歐盟的市場潛力。但現在我們可以說，這種藥物的重要性、功效和安全性都得到了世界所有主要監管機構的認可。這是信心的重要指標。

This is, again, the first disease-modifying agent that has ever been approved in Alzheimer's. This is a brand-new territory, and I think having that kind of regulatory endorsement is extremely important.

這又是第一個被批准用於治療阿茲海默症的疾病改良劑。這是一個全新的領域，我認為獲得這種監管認可極為重要。

Now as we all know, this has been a challenging product to launch given the workload that this applies for the treating physician. And we're looking very much forward to a number of the innovations that are coming along that we think can actually reduce that workload.

眾所周知，考慮到這款產品為主治醫師帶來的工作量，它的推出是一個頗具挑戰性的產品。我們非常期待即將出現的一系列創新，我們認為這些創新實際上可以減輕工作量。

First, of course, is one we have in the bag in the first quarter, which was the approval for the IV maintenance, which will allow us to reduce the dosing for patients after 18 months of treatment to once per month. Then we're going to make that even easier for physicians with hopefully an approval in August for the subcutaneous formulation, and that offers the potential of at-home administration with an auto-injector.

首先，當然是我們在第一季就已取得的成果，即靜脈維持治療的批准，這將使我們能夠將接受 18 個月治療的患者用藥劑量減少到每月一次。然後，我們將使醫生能夠更輕鬆地完成這一過程，希望皮下注射劑型能夠在 8 月獲得批准，並且這為使用自動注射器進行家庭給藥提供了潛力。

And of course, in the first half of next year, we're looking forward to the approval, hopefully again, of the subcutaneous formulation for initiation, which will dramatically reduce the need for infusion bed capacity.

當然，我們期待明年上半年再次批准皮下製劑的啟動，這將大大減少對輸液床容量的需求。

In addition, of course, this isn't related to Eisai or Biogen, these are independent companies, but they are companies who are pursuing approval for biomarker tests, blood-based biomarker tests. And hopefully, at some point, we'll be able to see those blood-based biomarkers supplant the need for PET scans and/or lumbar punctures.

此外，當然，這與 Eisai 或 Biogen 無關，它們是獨立的公司，但它們是正在尋求生物標記測試、基於血液的生物標記測試批准的公司。希望在某個時候，我們能夠看到這些基於血液的生物標記取代 PET 掃描和/或腰椎穿刺的需要。

So there's an awful lot of catalysts coming for LEQEMBI, but we're very much encouraged now that we've got critical mass behind this. We've also launched a new approach on commercialization from April 01. We and our partners, Eisai have spent a lot of time going back through the data, thinking about the lessons learned and have adopted our commercial approach. And one of the things, for instance, that we will be doing this year is now starting direct patient engagement in Alzheimer's.

因此，LEQEMBI 面臨著大量的催化劑，但我們非常高興，因為我們已經獲得了臨界質量的支持。我們也從 4 月 1 日起推出了新的商業化方法。我們和我們的合作夥伴衛材花了很多時間回顧數據，思考所學到的經驗教訓，並採用了我們的商業方法。例如，我們今年要做的事情之一就是開始直接讓阿茲海默症患者參與其中。

Now switching to ZURZUVAE. This is a product that continues to do nicely with Q1 sales of $28 million. Since launch, we have now been able to treat 10,000 women with PPD. And the majority of those prescriptions are actually first-line therapy for postpartum depression.

現在切換到 ZURZUVAE。該產品繼續表現良好，第一季的銷售額達到 2800 萬美元。自推出以來，我們現在能夠治療 10,000 名患有 PPD 的女性。而這些處方中的大多數實際上是產後憂鬱症的第一線療法。

A lesson that we learned along the way was actually the physician who is the most important in treating postpartum depression is actually not the psychiatrists, but the OB/GYN. So 80% of our scripts in Q1, for instance, were from OB/GYNs.

我們一路走來學到的一個教訓是，治療產後憂鬱症最重要的醫生其實不是精神科醫生，而是婦產科醫生。例如，我們第一季的 80% 處方都來自婦產科醫師。

One of the most important things here is you're talking about a one-and-done treatment essentially. And so to make this commercially viable, you actually need to have writers expand, and we did see that. So we were able to expand the number of physicians writing this by 20% in Q1. But more importantly, it's getting physicians to write repeat prescriptions.

這裡最重要的事情之一是，你談論的本質上是一種一次性治療。因此，為了使其具有商業可行性，你實際上需要讓作家擴展，我們確實看到了這一點。因此，我們能夠在第一季將撰寫此書的醫生數量增加 20%。但更重要的是，它讓醫生開出重複處方。

And one of the most encouraging things is that we're not only seeing the repeat prescriptions, but I think as physicians gain the experience with ZURZUVAE, they're also gaining the confidence to actually go and be more proactive about diagnosing postpartum depression.

最令人鼓舞的事情之一是，我們不僅看到了重複處方，而且我認為隨著醫生在使用 ZURZUVAE 方面的經驗不斷積累，他們也獲得了信心，能夠更加積極主動地診斷產後憂鬱症。

And so I think we're actually seeing a virtuous cycle here where this positive response by patients is encouraging a greater attention to a disease that, unfortunately, I think, has been sadly neglected for so many women. So very good progress on ZURZUVAE. We've completed our own field expansion at Biogen, and that's been in place since the middle of the quarter.

所以我認為我們實際上看到了一個良性循環，患者的積極反應正在引起人們對這種疾病的更多關注，但不幸的是，我認為這種疾病對許多女性來說都被忽視了。ZURZUVAE 的進展非常好。我們已經完成了 Biogen 自己的現場擴展，並且自本季中期開始實施。

Now if I turn to SKYCLARYS, we had worldwide sales of $124 million. That's up 59% year-over-year and 21% quarter-on-quarter. We did have some effect from the IRA. You all know about the Medicare tax that has been put in place, and that had an effect. Actually, our gross sales in the US rose faster than our net sales in this quarter.

現在，如果我談到 SKYCLARYS，我們的全球銷售額為 1.24 億美元。與去年同期相比成長了 59%，與上一季相比成長了 21%。我們確實受到了愛爾蘭共和軍的一些影響。大家都知道醫療保險稅已經實施，而且已經產生了效果。實際上，本季我們在美國的總銷售額成長速度快於淨銷售額的成長速度。

One of the things about this disease, of course, is that this is in European origin as a genetic disease. And essentially, where you find the patients is where all the European explorers went in the world. And -- but logically, of course, and the biggest number of patients is in Europe. And there, we have had an awful lot of success in finding patients. It's actually, I think, easier to find them in Europe because they tend to be in centers, whereas they tend to be all over the country in the US.

當然，這種疾病的特徵之一是它起源於歐洲，是一種遺傳性疾病。本質上，找到病人的地方就是世界上所有歐洲探險家都去過的地方。但從邏輯上講，當然，患者最多的地區是歐洲。在那裡，我們在尋找病人方面取得了巨大的成功。事實上，我認為在歐洲更容易找到它們，因為它們往往位於中心，而在美國它們往往遍布全國各地。

But even in the US, our US team has been very creative in thinking about new tools to identify where patients are and find them. I can remember years ago with the acquisition of Genzyme, learning the key marketing component of rare disease, and that is finding needles in haystacks. And that's what this is all about is looking through social media, following family trees and looking for patients.

但即使在美國，我們的美國團隊也非常有創意地思考新工具來識別患者的位置並找到他們。我記得幾年前收購 Genzyme 時，了解了罕見疾病的關鍵行銷要素，那就是大海撈針。這就是我們透過社群媒體、追蹤家譜和尋找病人所做的一切。

And so how are we doing on that? If I could see the next slide, you can see that we've got a nice steady growth in patient numbers. We've got about 2,400 patients on therapy globally. It's now available in 26 markets. I would caution that not all of those patients yet are paying patients. We have had an approach of having early access programs in countries to ensure that patients benefit from treatment as soon as possible. And we are following up then with negotiations on a country-by-country basis. But the uptake is very satisfying.

那我們做得怎麼樣？如果我能看到下一張投影片，您就會發現我們的病患數量正在穩定成長。全球約有 2,400 名患者正在接受我們的治療。目前該產品已在 26 個市場上市。我要提醒的是，並非所有患者都是付費患者。我們在各國採取了早期治療計劃，以確保患者盡快得到治療。隨後，我們將根據每個國家的具體情況進行後續談判。但其吸收效果非常令人滿意。

When you think about the penetration into this market, as we benchmark this, the penetration is actually much higher than the average analog rare disease launch and actually in line pretty much with the SPINRAZA launch. I wasn't here for that, but as we've gone back and looked at it, the SPINRAZA launch was actually one of the best, if not the best launch of a rare disease product.

當您考慮對該市場的滲透率時，以我們為基準，滲透率實際上遠高於平均模擬罕見疾病的發布，並且實際上與 SPINRAZA 的發布基本一致。我當時不是為這件事而來的，但當我們回顧並回顧時，SPINRAZA 的推出實際上是罕見疾病產品中最好的推出之一，即使不是最好的。

So we're very happy with the progress of SKYCLARYS. Brazil approval is actually a very important market for us. There are a lot of patients in Brazil, again, going back to where Europeans went in the world. And having been in Brazil last year and met with a number of physicians, I know that this approval will be very welcome to patients there.

因此，我們對 SKYCLARYS 的進展感到非常高興。巴西的批准實際上對我們來說是一個非常重要的市場。巴西有很多患者，他們又回到了歐洲人去過的地方。去年我去過巴西，會見了一些醫生，我知道這項批准會受到那裡患者的熱烈歡迎。

Moving on to the pipeline. I think we made an awful lot of progress here as well. I mean you've heard me say, I think, time and time again that I think we had an extremely high-risk pipeline when I came here. First of all, it was highly concentrated in neuroscience. And that's always an issue when you only have one therapeutic area.

繼續前進到管道。我認為我們在這裡也取得了很大進展。我的意思是，我想你已經聽我說過很多次了，我認為當我來到這裡時，我們的管道風險極高。首先，它高度集中在神經科學領域。當你只有一個治療領域時，這始終是一個問題。

But neuroscience was also a little complicated because we don't always understand the underlying disease biology. The slowly progressing nature of those diseases mean that you often couldn't do a Phase II study, and so you go immediately into a Phase III study. So you end up doing incredibly expensive proof-of-concept studies as Phase III.

但神經科學也有點複雜，因為我們並不總是了解潛在的疾病生物學。這些疾病進展緩慢的特性意味著你通常無法進行第二階段的研究，因此你需要立即進入第三階段的研究。因此，您最終會在第三階段進行極為昂貴的概念驗證研究。

Now neuroscience is who we are, and we've not wanted to abandon that by any means. There's huge unmet need. But we did feel that we needed to add another pillar to our company's future growth. And the logical place to go was immunology. We've been in immunology since the founding of our company, particularly through MS.

現在，神經科學就是我們的事業，我們不想以任何方式放棄它。存在巨大的未滿足需求。但我們確實覺得需要為公司未來的發展增添另一個支柱。最合乎邏輯的去處是免疫學。自公司成立以來，我們一直從事免疫學研究，特別是多發性硬化症 (MS)。

And I quote my good friend and former colleague, Elias Zerhouni, who often said, we describe too many diseases by their symptoms and not by their cause. And when you get into immunology, actually, what's important is really the immune pathways. And that can lead you into a whole number of different indications. And that is something that Biogen actually understands very well.

我引用我的好朋友兼前同事 Elias Zerhouni 的話，他常說，我們根據症狀而不是病因來描述太多疾病。當你研究免疫學時，實際上，真正重要的是免疫途徑。這可以讓你了解許多不同的跡象。事實上，Biogen 非常了解這一點。

And so you can see on the left chart, we've been able to balance this now. We have got a nice balance between neurology, which has been the pride and home of Biogen for many years, but also, I think immunology, where I think we have a very strong right to play. And then, of course, with that concomitantly, if you look at the right chart, in immunology, one of the things you can do is do a proof of concept.

因此您可以在左圖中看到，我們現在已經能夠平衡這一點。我們在神經病學和免疫學之間取得了很好的平衡，神經病學多年來一直是 Biogen 的驕傲和根基，而我認為我們在免疫學方面也有很強的發揮空間。然後，當然，與此同時，如果你看一下正確的免疫學圖表，你可以做的事情之一就是進行概念驗證。

And Felzartamab is probably the best example of that. That is an ideal product where we've been able to get a very strong proof of concept. There is never a guarantee in any clinical trial, as all of you know, but I think as we look at the Phase III clinical trials for Felzartamab that we feel a whole lot more confident about that than some of the other trials where, again, we haven't had that.

Felzartamab 或許就是最好的例子。這是一個理想的產品，我們已經能夠獲得非常強大的概念證明。眾所周知，任何臨床試驗都沒有任何保證，但我認為，當我們回顧 Felzartamab 的 III 期臨床試驗時，我們對此比在其他一些試驗中更有信心，因為我們還沒有進行過這樣的試驗。

And so as you look at our pipeline, I think if I could go to the next chart, first thing I would point out, we have five Phase III studies that are initiating this year. And that's important from a number of points of view. First is, obviously, there is a huge potential that is behind all of those products, and we're getting into late-stage development. So it's a sign of maturation of our pipeline.

因此，當您查看我們的管道時，我想如果我可以轉到下一張圖表，首先我要指出的是，我們有五個第三階段研究將於今年啟動。從很多角度來看這都很重要。首先，顯然所有這些產品都蘊藏著巨大的潛力，而我們正進入後期開發階段。所以這是我們管道成熟的標誌。

But the second thing is we're also increasing the number of shots on goal. We're not dependent on one or two projects. And we're going to continue to build that. And I guess the third thing I would point out is we have a number of data readouts that are coming. And so as we move into Phase III, we'll be able to also have some important readouts already in 2026. And I think that's a nice cadence that is going to help underpin the continued emergence of that new Biogen. So I think very good progress, and Priya is going to talk more about that.

但第二件事是我們也增加了射門的次數。我們並不依賴一兩個項目。我們將繼續建構這套體系。我想指出的第三件事是，我們即將獲得大量數據讀數。因此，當我們進入第三階段時，我們將能夠在 2026 年獲得一些重要的讀數。我認為這是一個很好的節奏，將有助於支撐新 Biogen 的持續崛起。所以我認為這是非常好的發展，Priya 將會就此進行更多討論。

And then I guess the last topic I would just cover is one that I think is on everybody's mind, which is tariffs. It's a new topic for us all. In 35 years in this industry, I've never had to spend as much time as we as a team have on tariffs in the first quarter. This is a very complicated area, and I know for investors, this is very complicated.

我想我要談的最後一個話題也是我認為大家都關心的話題，那就是關稅。對我們所有人來說，這都是一個新話題。我從業 35 年來，從來沒有像我們團隊一樣在第一季花費這麼多時間在關稅問題上。這是一個非常複雜的領域，我知道對於投資者來說，這非常複雜。

And I did want to point out a number of features of Biogen, which I think differentiate Biogen from some of our colleague companies in the industry. And a number of you have been using, for instance, the tax rate as a surrogate for what the tariff exposure might be. And I would submit to you that, that's actually not appropriate in the case of Biogen. And it's for a couple of important reasons.

我確實想指出 Biogen 的一些特點，我認為這些特點使 Biogen 與業內的一些同行公司區分開來。例如，你們中的許多人一直使用稅率來取代關稅風險。我想告訴你們，對於 Biogen 來說，這實際上是不合適的。這是出於幾個重要的原因。

The first is that when you look at our product sales, 75% of our 2024 US product revenue was attributable to products that already have manufacturing operations in the US. And in fact, Biogen actually exports more than we import. And as a result also, we also pay an awful lot of tax, and Robin will talk about that, but we pay taxes in the US at federal and state rates.

首先，當您查看我們的產品銷售時，我們 2024 年美國產品收入的 75% 歸因於已經在美國開展製造業務的產品。事實上，Biogen 的出口量大於進口量。因此，我們也繳了大量的稅，羅賓會談到這一點，但我們在美國按照聯邦和州的稅率納稅。

But the other structural difference is that approximately 55% of our 2024 product revenue came from countries outside the US. Now that's pretty unusual in our business. In most of this industry, what you see is 60% to 80% of product revenues come from the US. Biogen is a whole lot more diversified, and that's really a function of the products that we have.

但另一個結構性差異是，我們 2024 年產品收入的約 55% 來自美國以外的國家。這在我們的業務中相當不尋常。在這個行業的大部分領域，你會看到 60% 到 80% 的產品收入來自美國。Biogen 的業務更加多樣化，這實際上取決於我們的產品。

So as we look out for 2025, obviously, there is an exemption for the moment in place, and we know that the whole tariff situation is changing daily, and it's difficult to predict. But at least what we can say is even if we lost the exemption and all of those tariffs that were announced by the US administration on April 22 were to actually not only come into being, but also apply to pharmaceuticals, this would still not affect our 2025 financial outlook.

因此，當我們展望 2025 年時，顯然目前存在豁免，我們知道整個關稅情況每天都在變化，很難預測。但至少我們可以說，即使我們失去了豁免權，並且美國政府於 4 月 22 日宣布的所有關稅實際上不僅生效，而且還適用於藥品，這仍然不會影響我們 2025 年的財務前景。

That's partly because of the long supply chains we have. It's partly because -- and I have to credit our supply chain team. They've built levels of inventory, not just of products, but also of different ingredients and materials because, again, this is a highly complex area. But just structurally, we are more of a US-based company and always have been, and actually, we're quite proud of that.

部分原因是因為我們擁有較長的供應鏈。部分原因是——我必須讚揚我們的供應鏈團隊。他們建立了不同等級的庫存，不僅包括產品，還包括不同成分和材料的庫存，因為這是一個非常複雜的領域。但從結構上來說，我們更像是一家美國公司，而且一直都是，事實上，我們對此感到非常自豪。

So with that, I'm going to pass that on to Priya to pick up the story on R&D.

因此，我將把這個交給 Priya 來講述研發方面的故事。

Thank you, Chris. This quarter, we made significant progress advancing and expanding our high conviction late-stage pipeline. We believe our pipeline will play a critical role as we work to deliver sustainable long-term growth, enabled by increased momentum in our data flow. This includes potential key approvals this year and expected registrational data starting next year.

謝謝你，克里斯。本季度，我們在推進和擴大我們高度確信的後期管道方面取得了重大進展。我們相信，在我們努力實現可持續的長期成長的過程中，我們的管道將發揮關鍵作用，這得益於我們資料流的不斷增長。其中包括今年可能獲得的關鍵批准和明年開始的預期註冊數據。

This quarter, we delivered key milestones across Alzheimer's, immunology and rare disease. First, as Chris mentioned, our tau-targeting ASO, BIIB080, received Fast Track designation from the FDA in Alzheimer's disease in April.

本季度，我們在阿茲海默症、免疫學和罕見疾病領域取得了重要里程碑。首先，正如克里斯所提到的，我們的針對 tau 的 ASO，BIIB080，於 4 月獲得了 FDA 在阿茲海默症方面的快速通道認證。

Alzheimer's is a complex and fatal disease that we believe will require multiple therapeutic approaches to address its diversified pathologies. BIIB080 is a differentiated approach to targeting tau and the Fast Track designation was based on encouraging Phase Ib data, which showed dose-dependent CSF tau reductions, decreases in tau PET signal and favorable trends on exploratory, cognitive and functional measures.

阿茲海默症是一種複雜且致命的疾病，我們認為需要多種治療方法來解決其多樣化的病理。BIIB080 是一種針對 tau 的差異化方法，其快速通道稱號基於令人鼓舞的 Ib 期數據，該數據顯示劑量依賴性 CSF tau 減少、tau PET 信號降低以及探索性、認知和功能測量的良好趨勢。

In immunology, we initiated the TRANSCEND Phase III study of Felzartamab in AMR. This is the first of 3 Phase III studies that we expect to initiate this year for Felzartamab with additional studies in IgAN and PMN anticipated by midyear.

在免疫學領域，我們啟動了Felzartamab在AMR治療的TRANSCEND III期研究。這是我們預計今年針對 Felzartamab 啟動的 3 個 III 期研究中的第一項，預計在年中將針對 IgAN 和 PMN 進行更多研究。

And importantly, we expanded our late-stage rare disease pipeline where we acquired rights to Zorevunersen in Dravet syndrome in all territories outside the United States, Canada and Mexico. Dravet syndrome is a developmental and epileptic encephalopathy characterized by severe recurrent seizures and importantly, significant cognitive and behavioral impairments.

重要的是，我們擴大了後期罕見疾病藥物研發管線，並獲得了在美國、加拿大和墨西哥以外所有地區使用 Zorevunersen 治療 Dravet 症候群的權利。Dravet 症候群是一種發展性和癲癇性腦病，其特徵是嚴重的複發性癲癇，更重要的是，嚴重的認知和行為障礙。

Importantly, more than 90% of patients continue to experience seizures despite treatment with the best available antiseizure medicines and there are currently no medications approved that meaningfully address the underlying cognitive and behavioral aspects of the disease.

重要的是，儘管採用了最好的抗癲癇藥物治療，仍有超過 90% 的患者繼續出現癲癇發作，而且目前尚無任何獲批的藥物能夠有效解決該疾病的潛在認知和行為方面的問題。

Zorevunersen is an investigational ASO that is designed to potentially, for the first time, treat the underlying cause of Dravet syndrome by increasing the NaV1.1 protein production in brain cells. What encourages us about this asset is the Phase I/IIa data that we've seen, specifically in respect to cognition and behavior as well as seizure.

Zorevunersen 是一種研究性 ASO，旨在透過增加腦細胞中的 NaV1.1 蛋白質產生來首次治療 Dravet 症候群的根本原因。令我們對這項資產感到鼓舞的是，我們已經看到了 I/IIa 期數據，特別是有關認知和行為以及癲癇發作的數據。

And looking at the right-hand side of this slide, you can see why. Scores on the Vineland-3, a widely used standardized assessment of behavioral outcomes show that Zorevunersen resulted in substantial improvements across multiple measures of cognition and behavior. This was initially observed within the Phase I/IIa study with continued improvement in the open-label extensions out to two years.

看看這張投影片的右側，你就會明白原因。Vineland-3（一種廣泛使用的標準化行為結果評估）的得分錶明，Zorevunersen 在多項認知和行為指標上都取得了顯著的改善。這最初是在 I/IIa 期研究中觀察到的，並且在長達兩年的開放標籤擴展中持續改善。

We believe these results support the potential for Zorevunersen to be the first disease-modifying therapy in Dravet syndrome. We look forward to working with Stoke on advancing the Phase III EMPEROR study, which we expect to initiate in the next few months.

我們相信這些結果支持 Zorevunersen 成為 Dravet 症候群的首個疾病改良療法的潛力。我們期待與斯托克合作推進第三階段 EMPEROR 研究，該研究預計將在未來幾個月內啟動。

We continue to remain focused on advancing the standard of care in Alzheimer's, and I believe we've made significant progress. Starting with LEQEMBI, we are really excited about the recent approval in Europe. We're also continuing to advance the subcutaneous formulation for both treatment maintenance and initiation to further aid patient optionality and convenience.

我們將繼續致力於提高阿茲海默症的治療標準，我相信我們已經取得了重大進展。從 LEQEMBI 開始，我們對歐洲最近批准的情況感到非常興奮。我們也將繼續改進用於維持治療和開始治療的皮下製劑，以進一步幫助患者獲得選擇性和便利性。

Furthermore, we believe that the strength of the LEQEMBI real-world data continues to support the urgency to treat symptomatic early AD patients today. And we look forward to the potential of blood-based diagnostics to help remove barriers in the health care system.

此外，我們相信，LEQEMBI 真實世界數據的強度繼續支持當今治療有症狀的早期 AD 患者的緊迫性。我們期待血液診斷技術能幫助消除醫療保健系統中的障礙。

I also believe it is important that we continue to execute on the opportunity in presymptomatic AD. Clarity AD established that removing plaque in a symptomatic early AD population leads to clinical benefit and that symptomatic patients with low or no tau can potentially achieve an even greater benefit. And we believe AHEAD 3-45 is the right study design to evaluate the potential benefit of LEQEMBI in a true presymptomatic population.

我還認為，繼續抓住症狀前 AD 的機會​​非常重要。 Clarity AD 證實，清除有症狀的早期 AD 族群中的斑塊可帶來臨床益處，而 tau 水平低或無 tau 的有症狀患者可能獲得更大的益處。我們相信 AHEAD 3-45 是評估 LEQEMBI 在真正的症狀前人群中的潛在益處的正確研究設計。

Beyond LEQEMBI, we continue to treat target Alzheimer's disease biology with the potential next wave of therapies, including BIIB080 and novel delivery technologies. Overall, I'm encouraged by the progress we are making in Alzheimer's and believe we are well positioned to lead the evolution of the treatment landscape.

除了 LEQEMBI 之外，我們還將繼續利用潛在的下一波療法來治療阿茲海默症生物學，包括 BIIB080 和新穎的遞送技術。總的來說，我們在阿茲海默症治療方面的進展讓我感到鼓舞，並相信我們有能力引領治療領域的變革。

Turning to the pre-proof-of-concept pipeline. I'm excited again about the progress we've made in rebuilding this area of the pipeline. We are applying a strong scientific rationale as we invest in these programs using a disciplined data-driven decision-making approach as we aim to build out a sustainable pipeline with a promising pre-POC pipeline.

轉向概念驗證前管道。我再次對我們在重建管道這一區域方面取得的進展感到興奮。我們在投資這些項目時運用了強有力的科學原理，採用嚴謹的數據驅動決策方法，旨在透過有前景的 POC 前管道建立可持續發展的管道。

During this quarter, we made significant progress in this area, including completing enrollment in the Phase II study for our LRRK2 inhibitor for idiopathic Parkinson's disease with Denali. Applying our approach to follow the science, these Phase II data, which are expected next year, will help provide us with clarity on the potential path forward to Phase III.

本季度，我們在該領域取得了重大進展，包括與 Denali 合作完成針對特發性帕金森氏症的 LRRK2 抑制劑的 II 期研究招募。運用我們遵循科學的方法，這些預計明年發布的第二階段數據將有助於我們明確進入第三階段的潛在路徑。

We will continue to maintain this approach as we work to grow the pipeline by introducing more assets into the early-stage development, both from our organization as well as external innovation sources.

我們將繼續保持這種方法，透過在早期開發中引入更多資產（包括來自我們組織以及外部創新來源）來擴大管道。

With that, I would now like to hand the call over to Robin for a financial update.

說完這些，我現在想把電話交給羅賓，讓他報告財務最新狀況。

Thank you, Priya. I'm pleased to be participating in my first earnings call since stepping into the CFO role. I'd like to begin by extending my gratitude to those in the investment community with whom I've had the pleasure of speaking with in my first few months as CFO, and I'm looking forward to spending time with many more of you in the near future.

謝謝你，普里亞。我很高興參加擔任財務長以來的第一次財報電話會議。首先，我要向投資界的各位朋友表示感謝，在我擔任財務長的頭幾個月裡，我有幸與他們進行了交談，並期待在不久的將來能與更多的人共度時光。

To start, I would like to provide a few highlights on our first quarter financial results. Please note the comparisons I'm about to make are versus the first quarter of 2024, unless otherwise noted. Total revenue for the first quarter of $2.4 billion was up 6% year-over-year, aided in part by the timing of SPINRAZA and corporate partner revenue shipments. Our four launch products delivered approximately $200 million of revenue in the first quarter, an increase of 22% quarter-over-quarter and more than doubling year-over-year.

首先，我想介紹一下我們第一季財務表現的一些亮點。請注意，除非另有說明，我將要進行的比較是與 2024 年第一季進行的。第一季總營收為 24 億美元，年增 6%，部分原因是 SPINRAZA 和企業合作夥伴收入出貨的時間安排。我們推出的四款產品在第一季創造了約 2 億美元的收入，季增 22%，比去年同期成長一倍以上。

First quarter non-GAAP diluted EPS was $3.02, which was down 18%. This includes the $165 million upfront paid in connection with the Stoke transaction, which impacted EPS by approximately $0.95 in the quarter. Absent that charge, first quarter non-GAAP diluted EPS would have been $3.97, up 8% year-over-year.

第一季非公認會計準則稀釋每股收益為 3.02 美元，下降 18%。其中包括與 Stoke 交易相關的 1.65 億美元預付款，這導致本季每股收益下降約 0.95 美元。如果不計入該費用，第一季非 GAAP 稀釋每股收益將為 3.97 美元，年增 8%。

In the first quarter, we generated $222 million of free cash flow, which includes the $165 million upfront paid to Stoke. We ended the quarter with $2.6 billion of cash. Shortly, I will provide an update on our full year guidance.

第一季度，我們產生了 2.22 億美元的自由現金流，其中包括支付給 Stoke 的 1.65 億美元預付款。本季末我們的現金為 26 億美元。很快，我將提供有關我們全年指導的最新資訊。

Now I'll turn to a few comments on revenue and commercial dynamics in the first quarter. Starting with our MS franchise, our global product revenue declined 11% year-over-year, driven primarily by competition. This included impacts from a biosimilar for TYSABRI in Europe and generic competition for TECFIDERA globally. We have started to see generics launch in certain countries in Europe, such as France and the Netherlands. While we will continue to vigorously defend our IP, we do expect to see further impacts from TECFIDERA generics in Europe this year.

現在我將就第一季的營收和商業動態發表一些評論。從我們的 MS 特許經營權開始，我們的全球產品收入比去年同期下降了 11%，主要原因是競爭。這包括歐洲 TYSABRI 生物相似藥的影響以及全球 TECFIDERA 仿製藥的競爭。我們已經開始看到仿製藥在歐洲某些國家上市，例如法國和荷蘭。雖然我們將繼續大力捍衛我們的智慧財產權，但我們確實預計今年 TECFIDERA 仿製藥將在歐洲產生進一步的影響。

A bright spot for MS in Q1 was VUMERITY, where we saw an increase in demand, and VUMERITY remains the number 1 branded oral therapy. For SPINRAZA, we continue to be encouraged by the consistency in demand globally, which includes growth in the US of 4% year-over-year.

第一季 MS 的一個亮點是 VUMERITY，我們看到其需求增加，並且 VUMERITY 仍然是排名第一的品牌口服療法。對 SPINRAZA 而言，我們持續受到全球需求穩定成長的鼓舞，其中包括美國年增 4%。

In the first quarter, ex-US SPINRAZA revenue benefited from a onetime VAT refund and the timing of shipments in certain markets, which together was a benefit of approximately $26 million versus Q1 of 2024. And as I mentioned earlier, our four launch products together delivered $200 million of revenue to Biogen in the first quarter, an increase of 22% quarter-over-quarter and more than doubling year-over-year.

第一季度，美國以外的 SPINRAZA 收入受益於一次性增值稅退稅和某些市場的發貨時間，與 2024 年第一季相比，合計收益約為 2,600 萬美元。正如我之前提到的，我們的四款上市產品在第一季為 Biogen 帶來了 2 億美元的收入，季增 22%，比去年同期成長一倍以上。

We continue to see steady sequential growth of LEQEMBI with first quarter global in-market sales booked by Eisai of approximately $96 million, up approximately 11% sequentially from the fourth quarter of 2024. Global SKYCLARYS revenue was $124 million, a sequential increase of 21% versus the fourth quarter of 2024, driven by continued geographic expansion outside the US.

我們繼續看到 LEQEMBI 的連續穩定成長，衛材第一季全球市場銷售額約為 9,600 萬美元，較 2024 年第四季環比成長約 11%。SKYCLARYS 全球營收為 1.24 億美元，與 2024 年第四季相比環比成長 21%，這得益於美國以外地區持續的地理擴張。

Revenue for SKYCLARYS in the US was $69 million, impacted by expected Medicare discount dynamics, partially offset by demand growth. And both ZURZUVAE and QALSODY continued to grow sequentially, driven by increases in demand for each product.

SKYCLARYS 在美國營收為 6,900 萬美元，受預期醫療保險折扣動態的影響，但被需求成長部分抵消。由於每種產品的需求增加，ZURZUVAE 和 QALSODY 均持續連續成長。

The increase in corporate partner revenue in the first quarter was driven by the timing of certain batch commitments related to our contract manufacturing business, some of which was associated with batches of LEQEMBI. We continue to believe that corporate partner revenue will be roughly consistent when comparing full year 2025 with full year 2024. Due to planned maintenance activities and the timing of batch releases, we expect minimal corporate partner revenue in Q4.

第一季企業合作夥伴收入的成長是由與我們的合約製造業務相關的某些批次承諾的時間所推動的，其中一些與 LEQEMBI 批次有關。我們仍然相信，將 2025 年全年與 2024 年全年進行比較，企業合作夥伴的收入將大致保持一致。由於計劃的維護活動和批量發布的時間，我們預計第四季度企業合作夥伴收入將很少。

I'll now turn to a few comments regarding expenses. First quarter non-GAAP cost of sales was impacted by increased lower-margin contract manufacturing revenue. Non-GAAP core operating expense or R&D plus SG&A expense decreased 1% year-over-year as benefits from our R&D prioritization and Fit for Growth initiatives allowed us to absorb incremental spend associated with our advancing and expanding development pipeline as well as our product launches.

現在我想談一些有關費用的評論。第一季非公認會計準則銷售成本受到低利潤合約製造收入增加的影響。非公認會計準則核心營運費用或研發加銷售、一般及行政費用年減 1%，因為我們的研發優先順序和「適合成長」計畫使我們能夠吸收與推進和擴大開發管道以及產品發布相關的增量支出。

Non-GAAP operating income included approximately $201 million of acquired in-process R&D charges, including the $165 million upfront payment made in connection with the Stoke transaction, which had an approximately $0.95 impact to EPS.

非公認會計準則營業收入包括約 2.01 億美元的在研研發費用，其中包括與 Stoke 交易相關的 1.65 億美元預付款，這對每股收益產生了約 0.95 美元的影響。

Excluding the $165 million upfront payment, non-GAAP operating income would have been $748 million, up 7% year-over-year. As a reminder, we and our peers are required to present upfront and milestone charges in GAAP and non-GAAP operating results.

不包括 1.65 億美元的預付款，非 GAAP 營業收入將達到 7.48 億美元，較去年同期成長 7%。提醒一下，我們和我們的同行必須在 GAAP 和非 GAAP 經營業績中列示前期費用和里程碑費用。

Commencing this quarter, we will break out acquired in-process R&D, including upfronts and milestones in a separate line item in our P&L, consistent with many of our peers. We believe this provides better transparency about our core R&D activities and business development activities. We plan to disclose a schedule of expected charges for each quarter ahead of our earnings calls to aid in modeling.

從本季開始，我們將在損益表中單獨列出已收購的在研研發成果，包括預付款和里程碑，這與我們的許多同行一致。我們相信這將使我們的核心研發活動和業務發展活動更加透明。我們計劃在收益電話會議之前披露每個季度的預期費用表，以幫助建立模型。

Now I'd like to provide a brief update on our balance sheet. We generated $222 million of free cash flow in the first quarter, which takes into account the aforementioned $165 million upfront payment to Stoke. We ended the quarter with $2.6 billion of cash and approximately $3.7 billion of net debt and believe that our balance sheet remains strong, allowing us to continue to invest in both internal and external growth opportunities.

現在我想簡單介紹一下我們的資產負債表。我們在第一季產生了 2.22 億美元的自由現金流，其中包括前面提到的支付給 Stoke 的 1.65 億美元預付款。本季末，我們的現金為 26 億美元，淨債務約為 37 億美元，我們相信我們的資產負債表依然強勁，這使我們能夠繼續投資於內部和外部成長機會。

Turning now to guidance, where we are pleased that our expected underlying business outlook for the year has not materially changed. We are updating our full year EPS guidance to reflect the approximately $0.95 impact from the Stoke transaction along with $0.20 of an earnings tailwind from foreign exchange impacts from a weaker US dollar. We now expect our full year 2025 non-GAAP diluted earnings per share to be between $14.50 and $15.50.

現在談到指導，我們很高興看到，我們對今年預期的基本業務前景沒有重大變化。我們正在更新全年每股收益指引，以反映斯托克交易帶來的約 0.95 美元的影響，以及美元疲軟帶來的外匯影響帶來的 0.20 美元的收益順風。我們現在預計 2025 年全年非 GAAP 稀釋每股收益將在 14.50 美元至 15.50 美元之間。

We continue to expect total revenue for 2025 to decline by a mid-single-digit percentage, driven primarily by an increased decline in our MS business. We expect that our launch products will generate sequential revenue growth, but we expect the absolute MS revenue decline to be steeper than this growth in 2025.

我們仍預期 2025 年的總營收將下降中位數個位數百分比，主要原因是我們的 MS 業務下滑幅度加大。我們預計，我們推出的產品將帶來連續的收入成長，但我們預計到 2025 年，MS 的絕對收入下降幅度將大於這一增長幅度。

As a reminder, we expect a potential biosimilar entry for TYSABRI in the US, which we believe could occur sometime in the fourth quarter of this year. And as I mentioned a few minutes ago, we have started to see generics for TECFIDERA enter in Europe. And while we will continue to vigorously defend our IP, we do expect to see further impacts from generics in Europe this year.

提醒一下，我們預計 TYSABRI 的生物相似藥可能會在美國上市，我們相信這可能會在今年第四季的某個時候發生。正如我幾分鐘前提到的，我們已經開始看到 TECFIDERA 的仿製藥進入歐洲。雖然我們將繼續大力捍衛我們的智慧財產權，但我們預計今年歐洲的仿製藥將受到進一步的影響。

As I noted earlier, we believe that corporate partner revenue will be roughly consistent when comparing full year 2025 with full year 2024. Due to planned maintenance activities and the timing of batch releases, we expect minimal corporate partner revenue in Q4.

正如我之前提到的，我們認為，2025 年全年與 2024 年全年相比，企業合作夥伴的收入將大致保持一致。由於計劃的維護活動和批量發布的時間，我們預計第四季度企業合作夥伴收入將很少。

We believe we are on track to deliver the $1 billion of gross savings and $800 million of net savings under our Fit for Growth initiative. As you can see on the slide, many of our guidance considerations have remained the same as when we guided for the year back in February. I will also refer you to our press release for other important guidance assumptions.

我們相信，透過我們的「適合成長」計劃，我們有望實現 10 億美元的總節約和 8 億美元的淨節約。正如您在幻燈片上看到的，我們的許多指導考慮與我們在二月份指導今年的指導時一樣。我也會請您參閱我們的新聞稿，以了解其他重要的指導假設。

And finally, a topic of great interest to many investors is the impact to our business from tariffs. Biogen currently does not expect a material impact in 2025 from potential tariffs as announced by the administration -- US administration on April 2, 2025, even if the exemption for pharmaceuticals were to be removed.

最後，許多投資者非常感興趣的一個主題是關稅對我們業務的影響。目前，Biogen 並不認為美國政府在 2025 年 4 月 2 日宣布的潛在關稅會對 2025 年產生重大影響，即使取消藥品豁免。

This is based on both a significant portion of US revenue being derived from products which have manufacturing operations in the United States as well as our current global inventory position.

這是基於美國很大一部分收入來自在美國製造的產品以及我們目前的全球庫存狀況。

Our guidance range also considers potential retaliatory tariffs from China as announced. However, the US and international tariff landscape remains uncertain, and our guidance does not contemplate any new tariffs that may be announced in the future.

我們的指導範圍也考慮了中國宣布的潛在報復性關稅。然而，美國和國際關稅情況仍然不確定，我們的指導意見並未考慮未來可能宣布的任何新關稅。

I will also note that when excluding onetime tax impacts, our tax rate is broadly a function of our business mix and therefore, does not serve as a good proxy for estimating potential tariff impacts. Biogen's effective tax rate is a reflection of our US market revenues being almost entirely taxable in the US at the full federal plus state tax rates.

我還要指出的是，當排除一次性稅收影響時，我們的稅率大體上取決於我們的業務組合，因此，不能作為估計潛在關稅影響的良好代理。Biogen 的有效稅率反映了我們在美國市場的收入幾乎全部按照聯邦和州稅率繳納。

We also generate a relatively high percentage of our revenue outside the US, which is taxable in those markets and in the US under the GILTI regime. We will continue to monitor and analyze the current and future US and reciprocal tariff landscape as it evolves.

我們在美國以外地區產生的收入比例也相對較高，根據 GILTI 制度，這些收入在這些市場和美國均需納稅。我們將繼續監測和分析當前和未來的美國及互惠關稅情勢的發展。

I'll now pass the call over to Chris for some closing comments.

現在我將把電話轉給克里斯，請他發表一些結束語。

Thank you, Robin. Again, if I come back to where is Biogen going, you just have to look at our pipeline. We've got another four Phase III starts that's after the Phase III start already in AMR. We've got three clinical trial readouts coming. We've got three regulatory decisions coming.

謝謝你，羅賓。再說一次，如果我回到 Biogen 的發展方向，你只需要看看我們的管道。在 AMR 第三階段啟動之後，我們又啟動了另外四個第三階段。我們即將收到三份臨床試驗報告。我們即將做出三項監管決定。

One of the other things I'll say is in this first quarter is we did a major restructuring of research, and I'm really quite excited about what we're doing there. As an industry, we rely way too much on late-stage business development. The most cost-effective place to do collaborations is actually preclinically, and we have a goal of signing four to five new research collaborations this year.

我要說的另一件事是，我們在第一季對研究進行了重大重組，我對我們在那裡所做的事情感到非常興奮。作為一個產業，我們過度依賴後期業務發展。最具成本效益的合作實際上是臨床前階段，我們的目標是今年簽署四到五個新的研究合作協議。

Just on research, Biogen has been known for breakthrough medicines. In fact, all four products that we launched in 2023 and '24 are first-in-class, first-ever disease-modifying agents. And we go after some of the hardest-to-treat diseases.

僅從研究角度來看，Biogen 就因其突破性的藥物而聞名。事實上，我們在 2023 年和 2024 年推出的所有四種產品都是同類首創的、首創的疾病改良劑。我們致力於治療一些最難治療的疾病。

But one of the problems about being breakthrough is that you're in diseases where a lot of the investment committee is not already doing an awful lot of research. If I take AMR, the antibody-mediated rejection, for example, there's really no treatment there today.

但取得突破性進展的一個問題是，許多投資委員會尚未對所研究的疾病進行大量研究。以 AMR（抗體介導的排斥反應）為例，目前確實沒有治療方法。

And so one of the things that I think we feel that we would like to do is do a deeper dive into some of these diseases and pipeline assets, not with the intention of presenting new data, but to just say, okay, what's the competitive landscape? What's Biogen's right to win here? What's the patient journey? What is it going to really take to move the needle on one of these diseases? What's the reimbursement landscape going to be like? What's the epidemiology?

因此，我認為我們想做的事情之一就是更深入地研究其中一些疾病和管道資產，目的不是為了提供新的數據，而只是想說，好吧，競爭格局是什麼樣的？Biogen 憑什麼贏得這場勝利？患者的就診過程是怎麼樣的？要真正治癒這些疾病，需要做些什麼呢？報銷情況將會是怎樣？流行病學是怎麼樣的？

If I look at AMR, for example, I think this is a huge opportunity for Biogen. And we saw 80% resolution of AMR in Phase II trials. So we have a high level of confidence in that. But of course, a lot of people are interested in IgAN.

例如，如果我看一下 AMR，我認為這對 Biogen 來說是一個巨大的機會。我們在第二階段試驗中看到 AMR 的消退率為 80%。因此我們對此充滿信心。但當然，很多人對 IgAN 感興趣。

What's it going to take really to be interested in IgAN? And I spent an entire day with our West Coast hub just on Felzartamab. And there's a huge amount of things going on there. And even things like all CD38s are not created equally. So what are they like?

真正對 IgAN 感興趣需要什麼？我花了一整天的時間與我們的西海岸中心一起討論 Felzartamab。那裡正在發生很多事情。甚至所有 CD38 都不是平等的。那他們是什麼樣的呢？

So we would like to invite whoever is interested to come to some of these thematic seminars. The first one we're going to hold on June 11. And hopefully, that will be the first of a series. And it's just meant to be educational and a deeper dive, and we'll have some of our top internal experts here on all of these subjects to answer any and all questions.

因此，我們想邀請有興趣的人來參加一些專題研討會。第一次活動我們將於 6 月 11 日舉行。希望這是系列文章的第一篇。這只是為了教育和更深入的探討，我們將邀請一些頂級內部專家來解答所有這些主題的任何問題。

So with that, Tim, I'll turn it back to you for Q&A.

因此，提姆，我將把時間交還給你進行問答。

Thanks, Chris. Melinda, can we go to our first question, please?

謝謝，克里斯。梅琳達，我們可以開始第一個問題嗎？

(Operator Instructions)

（操作員指示）

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

Congrats on the recent LEQEMBI approval in Europe. Can you talk about what the rollout strategy could look like there and your sense of what the reimbursement process and amenability could be?

恭喜 LEQEMBI 最近在歐洲獲得批准。您能否談談那裡的推廣策略是什麼樣的，以及您對報銷流程和適應性的看法？

Yes. Thanks, Brian. Well, that is certainly going to take some time. The fact that the approval took a while tells you that there's an awful lot of thought going into that.

是的。謝謝，布萊恩。嗯，這肯定需要一些時間。批准花了一段時間，這表明我們對此進行了大量的思考。

One of the things about when you first -- when you launch a first-in-class, disease-modifying agent is that you're not displacing anything in a budget. So these types of products are incremental adds to the total health care budget of countries. And so that's sometimes where it's easier to launch a product that's kind of a me-too that comes in and can simply cannibalize the budget of another product.

當你首次推出一流的疾病改良劑時，需要注意的一點是，你不會在預算中取代任何東西。因此，這些類型的產品會增加各國醫療保健總預算。因此，有時推出一款模仿產品會更容易，而且這款產品很容易蠶食其他產品的預算。

So this is obviously a significant market in Europe. Europe is an aging continent, even more so than the United States. So there are an awful lot of eligible patients. But we'll be taking that with our partners, Eisai, market by market. I do think that also LEQEMBI has run the gauntlet. I mean there has been a full examination of the efficacy, the safety, but also the economic benefit.

因此這顯然是歐洲的重要市場。歐洲是一個老化大洲，其老化程度甚至比美國還要嚴重。因此符合條件的患者數量非常多。但我們將與我們的合作夥伴衛材一起，逐一市場地推進這一進程。我確實認為 LEQEMBI 也經歷了嚴峻考驗。我的意思是，我們已經對其功效、安全性以及經濟效益進行了全面的審查。

As you know, the EMA does take into account some aspects of the economic impact. So I think that in some ways, this deep interrogation by all of the countries of the European Union, by the way, I think should actually, if anything, help us as we go into reimbursement because this has been fully examined and fully evaluated. But I think it will be -- it will still take some time, and we'll go to some of the countries will launch clearly faster as is the case generally in Europe.

如您所知，EMA 確實考慮了某些方面的經濟影響。因此，我認為，從某種程度上來說，歐盟所有國家進行的深入質詢，順便說一句，實際上應該會對我們進行償還貸款有所幫助，因為這個問題已經過充分審查和充分評估。但我認為這仍然需要一些時間，而且我們會以更快的速度向一些國家推出這項服務，就像歐洲普遍的情況一樣。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

I wanted to touch again on LEQEMBI, but this time with the subcutaneous formulation. Maybe remind us how that potential for at-home administration can help accelerate sales in the United States. We're seeing some good uptake, but I think that, that could really help get things going further. And maybe some of the hurdles that you have to overcome to really get full penetration there.

我想再談談 LEQEMBI，但這次是皮下製劑。也許可以提醒我們，在家管理的潛力如何有助於加速美國的銷售。我們看到了一些良好的進展，但我認為這確實有助於事情進一步發展。也許你必須克服一些障礙才能真正全面滲透。

Right. So the first is subcutaneous for maintenance. And these are patients who have been going -- undergoing biweekly infusions now for 18 months. And so I think there are two aspects for the commercial. First is we are busy focusing on making sure that physicians and patients understand the need to continue on therapy.

正確的。因此首先是皮下注射進行維護。這些患者每兩週接受一次輸液，至今已持續了 18 個月。所以我認為商業廣告有兩個面向。首先，我們正忙於確保醫生和患者了解繼續治療的必要性。

And there, we have long-term extension data, and we have demonstrated that in 36 months after treatment, patients are still doing better on treatment than if they stop treatment. So there's the whole establishment of the maintenance market.

而且，我們有長期擴展數據，我們已經證明，在治療 36 個月後，患者的治療效果仍然比停止治療時更好。這就是整個維護市場的建立。

But if these are also older patients, and it's not always easy to get to infusion centers. Obviously, we make it easier with once monthly dosing. But our view is that this is going to be more effective as a long-term chronic therapy if you have a patient-friendly administration like subcutaneous. So I think as a first step, subcutaneous really helps establish and extends the treatment life of a patient in maintenance.

但如果這些患者年紀較大，去輸液中心就並不總是那麼容易。顯然，我們透過每月一次的劑量讓事情變得更容易。但我們認為，如果採用皮下注射等對患者友好的給藥方式，作為一種長期慢性療法，它將更有效。因此我認為作為第一步，皮下注射確實有助於建立和延長維持治療患者的治療壽命。

And then, of course, in the initiation phase, that will be interesting to see. I think in major urban centers, I think we may see that some physicians may want to continue at least in the first few months of therapy on infusion because they're timed with the MRIs to monitor ARIA and then move to subcutaneous.

當然，在啟動階段，這將會很有趣。我認為在主要城市中心，我們可能會看到一些醫生可能希望在治療的最初幾個月至少繼續進行輸液治療，因為他們會利用 MRI 來監測 ARIA，然後轉向皮下治療。

I can imagine in more rural settings where getting to infusion centers is not as easy for patients, that the subcutaneous might even be right from the get-go. So I think it will depend a little bit on where you are as a patient, but there's no question that this is, again, a simplification of the physician's workload.

我可以想像，在更多的農村地區，患者到達輸液中心並不容易，皮下注射可能從一開始就是正確的。所以我認為這在一定程度上取決於你作為患者的情況，但毫無疑問，這又簡化了醫生的工作量。

It's a heavy load to think about the PET scans or the lumbar punctures, going to negotiate for use of the infusion beds, which are often considered to be the domain of the oncologist. And just from a caregiver point of view of bringing the patient to the infusion center, I think this will be welcomed by them as well that they can do this at home. So I think this is an enabler for the patient, but also for the physician.

考慮 PET 掃描或腰椎穿刺是一個沉重的負擔，也要協商使用輸液床，而這些通常被認為是腫瘤科醫師的領域。僅從將患者帶到輸液中心的護理人員的角度來看，我認為他們也會歡迎這樣做，因為他們可以在家中做到這一點。所以我認為這不僅對患者有利，對醫生也有利。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Just following up on Evan's question here. Could you just speak to your thoughts on LEQEMBI uptick in growth on the forward, not only with subcutaneous maintenance dosing in the second half, but also with Fujirebio's in-vitro diagnostic, which should enter the market as well?

我只是在這裡跟進 Evan 的問題。您能否談談對 LEQEMBI 未來成長的看法，不僅包括下半年的皮下維持劑量，還有 Fujirebio 的體外診斷，它也應該進入市場？

Yes. We don't have that much information about the diagnostic. The process to get a diagnostic approved is different, obviously, than a drug. And then the reimbursement situation is also different.

是的。我們沒有太多關於診斷的資訊。顯然，獲得診斷批准的過程與獲得藥物批准的過程不同。那麼報銷情況也是不一樣的。

I do think the recent report by the Alzheimer's Association highlighted the need for early diagnosis. One of the issues that has, I think, been in Alzheimer's is that patients -- most patients are actually seeing their primary care physician, and it can take quite a long time for the physician to distinguish, is this just part of the normal aging process? Is this some other form of dementia? Or is this Alzheimer's?

我確實認為阿茲海默症協會最近的報告強調了早期診斷的必要性。我認為，阿茲海默症的一個問題是，大多數患者實際上都在看他們的初級保健醫生，而醫生可能需要很長時間才能辨別，這是否只是正常老化過程的一部分？這是其他形式的癡呆症嗎？還是這是阿茲海默症？

And so two or three years can go by and sometimes even longer before the Alzheimer's diagnostic is done through a referral to a neurologist.

因此，可能需要兩三年甚至更長時間才能透過神經科醫生的轉診進行阿茲海默症的診斷。

Now one of the things that, that Alzheimer's report also pointed out is that there's a real interest in getting treatment earlier. And that the earlier you can get to a patient before there has been too much neuronal damage or death, the better. And so I think there is a real effort to be done to really get those diagnostics established.

阿茲海默症報告也指出，人們對早期治療確實很感興趣。在出現過多的神經元損傷或死亡之前，越早治療患者越好。因此我認為需要付出真正的努力才能真正建立這些診斷方法。

And so the benefit really is, I think, twofold. One is, hopefully, we can get patients on treatment at a much earlier stage of their disease. And we believe and there's obviously studies ongoing to actually gain the evidence of that, but even the data that we presented at CTAD in 2023 of low tau patients, which is surrogate for early-stage patients demonstrated that 60% of patients were stable after six months and actually 70% -- sorry, 70% were stable after 6 months and 60% actually showed some level of improvement.

因此我認為其好處確實是雙重的。一是希望我們能夠讓患者在疾病的早期階段接受治療。我們相信，而且顯然正在進行的研究確實獲得了這方面的證據，但即使是我們在 2023 年 CTAD 上展示的低 tau 患者的數據（代表早期患者）也表明，60% 的患者在六個月後病情穩定，實際上 70% — — 抱歉，70% 的患者在 6 個月後病情穩定，60% 的患者顯示出一定程度的患者。

So I think the blood-based diagnostics are going to be extremely important. But again, we have to wait and see where those companies are in the regulatory process.

所以我認為基於血液的診斷將非常重要。但同樣，我們必須拭目以待，看看這些公司在監管過程中處於什麼位置。

Tim Anderson, Bank of America.

美國銀行的蒂姆·安德森。

On LEQEMBI, how are you seeing the market parse out between your product and Lilly's Kisunla? Because obviously, there's a very big difference in terms of commercial positioning around finite dosing. And I'm wondering who's going to kind of win that battle.

關於 LEQEMBI，您如何看待您的產品和禮來公司的 Kisunla 之間的市場分析？因為顯然，在有限劑量的商業定位方面存在很大差異。我想知道誰會贏得這場戰鬥。

And Chris, you answered an earlier question starting off talking about getting docs to keep patients on therapy. So the product -- your product is on the market now for coming up on 2.5 years. Are you actually seeing some prescribers take patients off therapy after a period under the idea that once plaque is gone, you no longer need to give drug?

克里斯，你回答了先前的問題，一開始就談到了讓醫生讓病人繼續接受治療。因此，該產品—您的產品現已上市兩年半了。您是否真的看到一些開藥者在一段時間後讓患者停止治療，因為他們認為一旦牙菌斑消失，就不再需要給患者用藥了？

Yes. I mean I think, first, I would say we would really consider the launch of this product to have been September of '23 because that's when we had full approval. We had reimbursement from CMS. In actual fact, we didn't even really get the question on the reimbursement for PET scans clarified until about November of that year. So I think we're still much earlier in that launch phase.

是的。我的意思是，首先，我想說我們確實會考慮在 23 年 9 月推出這款產品，因為那時我們獲得了完全批准。我們從 CMS 獲得了報銷。事實上，直到當年 11 月左右，我們才真正弄清楚有關 PET 掃描報銷的問題。所以我認為我們還處於啟動階段的早期階段。

To your question on this versus Donanemab, it depends on the physician. And I think we're going to see those who like this idea of potentially saying, well, there's a finite point to this. Equally, what we have seen even at the recent ADPD, once you have a maintenance indication and you start to see the data, you start to realize that, well, actually, once you've -- remove the plaque, you're not done because there is some return of the plaque and potential damage.

對於您關於此藥與 Donanemab 相比的問題，這取決於醫生。我認為我們會看到那些喜歡這個想法的人可能會說，嗯，這是有意義的。同樣，即使在最近的 ADPD 中我們也看到，一旦你有了維護指示，並且開始看到數據，你就會開始意識到，實際上，一旦你 - 去除了斑塊，你就不會完成，因為斑塊還會復發並造成潛在的損害。

So there will be obviously a lot of education to be done to demonstrate the importance of continuing on that. But I think at the end of the day, it's largely going to be up to the physician and the patient. There will be patients where Donanemab may be the right answer for them. It depends on their fragility, their age, whether they're in a rural setting or an urban setting. And I think the market ultimately just gets split between us and Donanemab.

因此，顯然需要進行大量的教育來證明繼續這樣做的重要性。但我認為，最終這很大程度取決於醫生和患者。對某些患者來說，Donanemab 可能是正確的選擇。這取決於他們的脆弱程度、年齡，以及他們生活在農村還是城市。我認為市場最終會被我們和 Donanemab 瓜分。

The most important thing for both Lilly, I think, and Biogen and Eisai is that we start to really expand this market. We've got maybe, I don't know, 12,000 patients, 13,000 patients somewhere in there on treatment, less for Donanemab, but they will get there.

我認為，對於禮來、百健和衛材來說，最重要的是我們開始真正擴大這個市場。我們可能有 12,000 名或 13,000 名患者正在接受治療，接受 Donanemab 治療的患者較少，但他們會成功的。

But when you consider the number of patients who desperately need treatment, we're still only treating a small fraction. And I think that's really got to be the focus of all the companies in this space is to really ensure that more patients benefit from these disease-modifying treatments.

但當你考慮到急需治療的患者數量時，我們仍然只治療了一小部分。我認為這個領域所有公司的真正重點是確保更多患者能夠從這些改善疾病的治療中受益。

Chris Schott, JPMorgan.

摩根大通的克里斯·肖特。

I just would love a bit more elaboration on latest thoughts on business development in terms of the size and scopes of deals you're considering. It's obviously been a pretty volatile market out there. And I'm just wondering if that's changing your views at all or the range of opportunities that might be available to Biogen.

我只是想就您正在考慮的交易的規模和範圍，更詳細地闡述有關業務發展的最新想法。顯然，這是一個相當動盪的市場。我只是想知道這是否會改變您的觀點或 Biogen 可能獲得的機會範圍。

Yes. Thanks for that question. I mean I think there is -- there has been a shift even perhaps in the last, I would say, four to six weeks. In a couple of ways, I mean, valuation is one thing, but you're still really focused on getting the right thing.

是的。謝謝你的提問。我的意思是，我認為——也許在過去四到六週內已經發生了轉變。從某些方面來說，我的意思是，估值是一回事，但你仍然要真正專注於獲得正確的東西。

And what I think has changed is you have a lot of health care investors who are facing a lot of pressure from LPs. And I think they are looking for liquidity. And I think we've had a lot of companies who not really wanted to do much because valuations are low. But we're also finding that there's a lot of companies who are struggling to get financing.

我認為已經發生的變化是，許多醫療保健投資者面臨來自 LP 的巨大壓力。我認為他們正在尋求流動性。我認為有很多公司因為估值低而不願意做太多事情。但我們也發現很多公司在融資上遇到困難。

So I think if you're looking to acquire, I think there might be a little bit more of an ease in actually getting at least into a discussion. But I think even from a collaboration point of view, I think one of the things we're going to see, and I think this is also where we're doing this in the early research collaborations, I think companies will be able to provide some of the funding as some of the venture capital and some of the other sources of funding dry up for other companies. And so there are opportunities in there.

因此，我認為，如果你想要收購，那麼實際上進行討論可能會更容易一些。但我認為，即使從合作的角度來看，我們將會看到的一件事，而且我認為這也是我們在早期研究合作中所做的事情，我認為公司將能夠提供部分資金，因為其他公司的部分風險資本和其他一些資​​金來源正在枯竭。因此這裡面存在著機會。

It still requires an awful lot of patience and discipline to work your way through and find companies that work together. I do think Biogen is actually well positioned. One of the things I'm particularly proud of is we have this West Coast hub, which is essentially the HI-Bio team. And we have been able to retain virtually everybody in that HI-Bio team. Jane has hired our Head of Immunology, came from BMS, who's out there on the West Coast, and we're building out that team.

要找到可以合作的公司，仍然需要極大的耐心和紀律。我確實認為 Biogen 確實處於有利地位。我特別自豪的事情之一是我們擁有這個西海岸中心，它基本上是 HI-Bio 團隊。我們幾乎保留了 HI-Bio 團隊中的所有員工。Jane 聘請了我們的免疫學主管，他來自西海岸的 BMS，我們正在組建這個團隊。

And so I think Biogen, just because of our own biotech roots is a company that knows how to do collaborations and I think can be a trusted partner in this. So I do think this is an opportunity. But again, and we look at a lot of things, but even in this environment, you still have to stay disciplined.

因此，我認為 Biogen 憑藉其自身的生物技術根基，是一家懂得如何開展合作的公司，我認為可以成為值得信賴的合作夥伴。所以我確實認為這是一個機會。但同樣，我們考慮了很多事情，即使在這種環境下，你仍然必須保持紀律。

Michael Yee, Jefferies.

麥可‧餘 (Michael Yee)，傑富瑞集團 (Jefferies)。

I wanted to ask Priya, about the early AHEAD 3-45 study. I know that you've guided to a 2028 readout. Your competitor is also guiding to a readout, although I think there's an assumption that, that may come earlier. Can you just talk about maybe one or two points about your positioning versus that study and particularly what would get you extremely confident that, that's going to work and/or readout? Because I know that you have an interim, but I'm just going to assume you're not going to take that interim.

我想向 Priya 詢問有關早期 AHEAD 3-45 研究的問題。我知道您已經引導了 2028 年的讀數。您的競爭對手也在引導讀數，儘管我認為有一個假設，那就是這可能會來得更早。您能否談談您對該項研究的定位的一兩點看法，特別是什麼讓您非常有信心該研究會起作用和/或讀出結果？因為我知道你有臨時職位，但我只是假設你不會接受那個臨時職位。

Yes. Thanks, Mike. So overall, I would say I'd like to start by saying that with Clarity AD, we established that LEQEMBI clears plaque and that translates to clinical benefit. Now with regards to the presymptomatic Alzheimer's disease area, it's a big spectrum. And we believe that AHEAD 3-45 is truly positioned to provide a comprehensive understanding and evaluation of how LEQEMBI can preserve cognition across the full spectrum of presymptomatic AD.

是的。謝謝，麥克。總的來說，我想首先要說的是，透過 Clarity AD，我們確定 LEQEMBI 可以清除牙菌斑，並轉化為臨床益處。現在就症狀前阿茲海默症領域而言，它是一個很大的範圍。我們相信，AHEAD 3-45 確實能夠提供全面的理解和評估，了解 LEQEMBI 如何在整個症狀前 AD 範圍內保持認知能力。

And the reason for that is that we are testing it in two parallel trials. The first one is AHEAD 3, which is about 400 subjects and really by the inclusion criteria are 20- to 40 centiloids of amyloid. And then the other trial is greater than 40 centiloids, which is the AHEAD 45, amyloid levels. And there, we are looking at whether it can prevent cognitive decline.

原因是我們正在進行兩次平行試驗來測試它。第一個是 AHEAD 3，涉及約 400 名受試者，根據納入標準，其中澱粉樣蛋白的百分比為 20 至 40。然後另一項試驗大於 40 個中心點，即 AHEAD 45，澱粉樣蛋白水平。我們正在研究它是否可以防止認知能力下降。

So AHEAD 3 is looking at can we stop the accumulation of amyloid, has amyloid PET as the primary endpoint. And then AHEAD 45 is looking at preventing cognitive decline, and we have a very sensitive clinical endpoint called the PAC5 along with amyloid and tau PET.

因此，AHEAD 3 正在研究我們是否可以阻止澱粉樣蛋白的積累，以澱粉樣蛋白 PET 為主要終點。然後，AHEAD 45 正在研究如何防止認知能力下降，我們有一個非常敏感的臨床終點，稱為 PAC5，以及澱粉樣蛋白和 tau PET。

I think in contrast, TRAILBLAZER-ALZ3 is really evaluating whether donanemab can slow clinical progression in a mixed population. And this is based on their baseline CDR global scores. So presymptomatic is about 55%, and they have included 45% of symptomatic patients. So these studies are actually quite different, and we are looking at the entire range of presymptomatic patients with varying degrees of amyloid.

我認為相較之下，TRAILBLAZER-ALZ3 實際上正在評估 donanemab 是否可以減緩混合族群的臨床進展。這是基於他們的基線 CDR 總體得分。因此，症狀前患者約佔 55%，其中有症狀患者佔 45%。因此，這些研究實際上是非常不同的，我們正在研究具有不同程度澱粉樣蛋白的所有無症狀患者。

We will -- we do expect -- we're fully enrolled. We do expect to read out in 2028. We always reserve the optionality of looking at data earlier or such, but we're not commenting on that. Right now, we are looking at a readout in 2028.

我們將——我們確實期望——我們已經完全入學。我們確實希望在 2028 年讀完。我們始終保留查看更早數據等的選擇權，但我們對此不予評論。目前，我們正在查看 2028 年的讀數。

And I think if I could just from a commercial point of view, I do think the AHEAD study will actually answer much more of the question that physicians will be looking to ask. I mean if you're in presymptomatic patients, these are otherwise healthy people, right? And the risk-benefit equation becomes different at that point. And there is ARIA that is associated with both products.

我認為，如果僅從商業角度來看，AHEAD 研究實際上將回答醫生想要問的更多問題。我的意思是，如果你面對的是無症狀患者，那麼他們都是健康的人，對嗎？此時風險收益方程式就變得不同了。並且有與這兩種產品相關的 ARIA。

So you're going to have to answer the question about the risk/benefit of treating earlier and at what level of amyloid burden. And I think that's going to be useful because the blood-based diagnostics will tell you that if there is a presence of amyloid, they will not tell you about how much.

因此，您必須回答有關早期治療的風險/益處以及澱粉樣蛋白負擔程度的問題。我認為這將是有用的，因為基於血液的診斷會告訴你是否存在澱粉樣蛋白，但不會告訴你澱粉樣蛋白的含量。

So at some point, you sort of say, 55, you had a positive blood test, someone is going to send you for a PET scan to see how much amyloid you have. And let's say you're at 50. Well, are you in a watch-and-wait mode? Or do you actually treat? And unless you've actually done the study of looking at the full spectrum of amyloid burden, I'm not sure that physicians are going to feel comfortable about treating. So I do think actually AHEAD 3 and 45 are going to be really landmark studies in Alzheimer's.

所以在某個時候，比如說，55 歲，你的血液檢測結果呈陽性，有人會送你去做 PET 掃描，看看你有多少澱粉樣蛋白。假設您已經 50 歲了。那麼，您處於觀望狀態嗎？還是你確實治療？除非你真的做過關於澱粉樣蛋白負擔全方位的研究，否則我不確定醫生是否會對治療感到放心。因此我確實認為 AHEAD 3 和 45 將成為阿茲海默症領域的里程碑式研究。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

This is Mike DiFiore on for Umer. Again, one on LEQEMBI. Lilly's drug did about $20 million -- $21 million of sales in Q1, which is its second full quarter of launch. And this tracks slightly ahead of LEQEMBI sales at the same time point.

我是 Mike DiFiore，代表 Umer 報道。再次，關於 LEQEMBI 的一個。禮來公司的這款藥物在第一季（即上市後的第二個完整季度）的銷售額約為 2,000 萬至 2,100 萬美元。這一銷量略高於同期 LEQEMBI 的銷量。

So my question is, has Biogen and Eisai perhaps paved the way for Lilly in terms of opening up health care infrastructure? And maybe perhaps could you speak to any competitive dynamics at play now that you're roughly 18 months into launch.

所以我的問題是，Biogen 和 Eisai 是否為 Lilly 在開放醫療基礎設施方面鋪平了道路？也許您能談談現在大約 18 個月以來出現的任何競爭動態嗎？

Well, I think the answer is probably, yes. Clearly, there's been a lot of hard work, particularly the IDNs to work through all the treatment pathways and protocols and treatment regimens that are needed. And so then now we're into a question of Lecanemab versus Donanemab in those questions. And as I said earlier, I think there will be cases where physicians are looking at both products.

嗯，我認為答案很可能是肯定的。顯然，我們付出了很多艱苦的努力，特別是 IDN 努力探索所有需要的治療途徑、方案和治療方案。那麼現在我們要討論的是 Lecanemab 與 Donanemab 之間的差異。正如我之前所說，我認為有些醫生會考慮這兩種產品。

I think it will be a question of who gets initiated. I don't think we're seeing any switching going on here. So it's really a question of which one are you going to start on and then stay on. I think the bigger question is, can we actually collectively grow the market. And that's really what's most important.

我認為這將是一個誰先發起的問題。我認為我們沒有看到這裡發生任何轉變。所以這其實就是一個問題：你要從哪一個開始並堅持下去。我認為更大的問題是，我們能否真正共同發展市場。這才是真正最重要的。

And I don't think we particularly want to get into just trying to duke it out over market share in a relatively still small market. There is -- there are a lot of patients out there, and we are not yet doing a full service to patients who are suffering. And so the more that we can get more centers up and running and better education, the better it will be for patients and actually for both companies.

我認為我們並不特別想在一個相對較小的市場中爭奪市場份額。確實，有很多病人，但我們還沒有為這些正在遭受痛苦的病人提供全面的服務。因此，我們建立和營運的中心越多，教育越好，對患者和兩家公司就越有利。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

Obviously, there's been a lot of focus on the FDA under the new administration. And I know you made some comments about your Dravet program moving into a Phase III. So just wondering if you could comment high level, number one, on your interactions with FDA and if there have been any changes to the review teams, things like that. But then also in some of these rare diseases, do you think this FDA is going to be advancing very rapidly and be more favorable to the industry in terms of thinking about maybe surrogate endpoints?

顯然，新政府對 FDA 給予了極大關注。我知道您對 Dravet 計劃進入第三階段發表了一些評論。所以我只是想知道您是否可以就您與 FDA 的互動發表高層評論，以及審查團隊是否有任何變化，諸如此類的事情。但是對於一些罕見疾病，您是否認為 FDA 將會迅速推進，並且在考慮替代終點方面對該行業更加有利？

Yes. Thank you. Overall, I'll just make a high-level statement that based on our interactions on review meetings and requests, we're not really seeing any changes at a high level. Currently, we remain on track with our engagements.

是的。謝謝。總的來說，我只想發表一個高層聲明，根據我們在審查會議和請求中的互動，我們實際上並沒有看到高層的任何變化。目前，我們的合作仍在順利進行中。

And with regards to Dravet syndrome, I think that obviously, the data that we saw during diligence and which I spoke to as well today, for us, that has been very compelling. That has been -- it has several aspects to it.

關於 Dravet 綜合徵，我認為，顯然，我們在盡職調查期間看到的數據以及我今天談到的數據對我們來說非常有說服力。那是——它有幾個面向。

First of all, this population, although it was a small open-label trial, I think what was important about it was that these patients were on standard of care. And unfortunately, the burden of disease is high in Dravet. And they have a number of seizures, sometimes 7 to 10 a week. And they are on multiple medications, antiseizure medications.

首先，儘管這是一項小規模的開放標籤試驗，但我認為重要的是這些患者接受了標準治療。不幸的是，德拉維特的疾病負擔很重。他們的癲癇發作次數較多，有時一週發作 7 至 10 次。他們正在服用多種藥物，包括抗癲癇藥物。

And in fact, we saw the impact of Zorevunersen on top of standard of care. So the impact that we saw was 87% seizure reduction on top of background standard of care, full standard of care. And then that was durable out to about 76% when you look out six months. So that -- the data was important.

事實上，我們看到了 Zorevunersen 對護理標準的影響。因此，我們看到的效果是在基礎護理標準和全面護理標準的基礎上，癲癇發作減少了 87%。如果從六個月來看，這一比例將持續至約 76%。所以——數據很重要。

But the other aspect to the question that you asked is that Stoke had already engaged with FDA, Europe and Japan. So we have regulator input, which we have evaluated carefully. We have agreement on the approach and design to the Phase III EMPEROR trial. So we remain fairly confident that this is the right trial to conduct.

但您提出的問題的另一個方面是，斯托克已經與 FDA、歐洲和日本進行了接觸。因此，我們有監管機構的投入，並且我們已經仔細評估過。我們就第三階段 EMPEROR 試驗的方法和設計達成了一致。因此我們仍然相當有信心，這是一次正確的試驗。

And so we remain encouraged about where we are in our engagement, not only with the FDA, but global regulators and that the design is appropriate to really give us that answer on what we hope will be a disease-modifying therapy impact in this population.

因此，我們對我們的合作現狀感到鼓舞，不僅與 FDA，而且與全球監管機構的合作也令人鼓舞，而且該設計確實可以為我們提供答案，我們希望該療法能夠對這一人群產生改變疾病的治療影響。

But I think to your broader question, I think certainly, right now at Biogen, we have not really seen any delays in our interactions with the FDA. And I personally am encouraged by some of the more recent comments by the new commissioner about particularly ultrarare and thinking about surrogate markers and making sure patients get drugs earlier.

但我認為對於您更廣泛的問題，我認為目前在 Biogen，我們與 FDA 的互動確實沒有出現任何延遲。我個人對新任專員最近關於特別罕見疾病、考慮替代標記以及確保患者儘早獲得藥物的一些評論感到鼓舞。

And I think he seems to be more interested in innovating some of the process, I think about his statements on reducing the use of animals in studies, for example, and use of AI. So there's certainly a lot of change going on at the FDA, and we're watching very carefully. And obviously, there's been some key leaders who have left and some reduction in staff.

我認為他似乎對創新某些流程更感興趣，例如我想到他關於減少研究中使用動物和使用人工智慧的聲明。因此，FDA 確實正在發生很多變化，我們正在密切關注。顯然，一些關鍵領導人已經離職，有些員工也減少了。

But I'd say so far, at least from a Biogen point of view, we haven't seen any adverse effect to that. And perhaps some of the new perspectives of the new commissioner, Makary could actually be helpful to us.

但我想說，到目前為止，至少從 Biogen 的角度來看，我們還沒有看到任何不利影響。也許新任專員馬卡里的一些新觀點實際上可能對我們有幫助。

I know it's a busy morning, so maybe we can squeeze one last question in here. Our last question, please.

我知道今天早上很忙，所以也許我們可以擠出時間問最後一個問題。請問這是我們的最後一個問題。

Geoff Meacham, Citibank.

花旗銀行的傑夫‧米查姆。

For Chris or Robin, on manufacturing, Biogen has historically had a lot of capacity in the US going back to the original expectations in Alzheimer's. I guess the question is, as we see more companies in biopharma announce plans to onshore capacity, do you guys view your own capacity or resources differently? I wonder if there's a short-term opportunity to partner that's not in the model. Obviously, all, of course, depends on what you have in excess.

對 Chris 或 Robin 來說，在製造業方面，Biogen 在美國一直擁有很大的產能，可以追溯到最初對阿茲海默症的預期。我想問題是，隨著我們看到越來越多的生物製藥公司宣布國內產能計劃，你們對自己的產能或資源有何不同看法？我想知道是否存在模型中沒有的短期合作機會。顯然，這一切都取決於你擁有多少多餘的東西。

Yes. We've actually recently -- our main facility in Solothurn, for example, we've recently -- there, we're actually doing CDMO business to absorb capacity. Obviously, that doesn't help for someone looking in the US. In RTP, we actually do quite a lot of manufacturing already for third-party companies. And I think even before I joined Biogen, I knew of the reputation of our RTP facility. It's a very high-quality, very efficient site. So yes, I think we certainly will be open and looking for opportunities on that front.

是的。實際上，我們最近——例如，我們在索洛圖恩的主要​​設施——在那裡，我們實際上正在進行 CDMO 業務來吸收產能。顯然，這對在美國尋找的人沒有幫助。在 RTP，我們實際上已經為第三方公司進行了相當多的製造。我想，甚至在我加入 Biogen 之前，我就知道我們的 RTP 設施的聲譽。這是一個非常高品質、非常有效率的網站。所以是的，我認為我們肯定會保持開放態度並尋找這方面的機會。

Yes. We have a good mix in both facilities between our own product manufacturing as well as those for partners.

是的。我們的工廠將自己的產品製造和合作夥伴的產品製造進行了很好的結合。

Well, thanks for your time, everybody. Really appreciate it. And if you've got more questions later today, just reach out to the IR team. Thank you.

好的，謝謝大家的時間。真的很感激。如果您今天稍後有更多問題，請聯絡 IR 團隊。謝謝。

This concludes today's conference. We thank you for your participation. You may disconnect at this time.

今天的會議到此結束。我們感謝您的參與。您現在可以斷開連線。