Biogen Inc (BIIB) 2025 Q3 法說會逐字稿

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

早安.我叫辛西婭，今天我將擔任你們的會議接線生。在此，我謹代表 Biogen 公司歡迎各位參加 2025 年第三季財報電話會議和業務更新。（操作說明）今天的會議正在錄音。謝謝。

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

接下來我將把會議交給投資人關係主管提姆·鮑爾。鮑爾先生，您可以開始您的會議了。

Thanks, Cynthia, and good morning, everyone. Welcome to Biogen's third quarter 2025 earnings call. During this call, we 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.

謝謝辛西婭，大家早安。歡迎參加 Biogen 2025 年第三季財報電話會議。在本次電話會議中，我們將發表前瞻性聲明，這些聲明涉及風險和不確定性，可能導致實際結果與我們的前瞻性聲明有重大差異。我們在提交給美國證券交易委員會的文件中提供了風險因素的完整清單，我建議您仔細閱讀。

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 for our webcast. We posted the slides on our website that will be used during this call.

我們的獲利報告和其他與績效相關的文檔，以及本次電話會議中討論的GAAP和非GAAP業績之間的調節表，都可以在biogen.com的投資者關係版塊找到。我們也發布了網路直播的幻燈片。我們已將本次電話會議將要使用的幻燈片發佈在我們的網站上。

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher. Dr. Priya Singhal, Head of Development; Alisha Alaimo, our President and Head of North America; and Robin Kramer, our Chief Financial Officer. We'll make some opening comments and then move to Q&A session and to allow us to get through as many questions as possible, we kindly ask that you limit yourself to just one question.

今天和我一起參加電話會議的還有我們的總裁兼執行長克里斯·維巴赫。Priya Singhal 博士，發展部主管；Alisha Alaimo，總裁兼北美區主管；以及 Robin Kramer，財務長。我們將作一些開場白，然後進入問答環節。為了盡量解答問題，請各位盡量只提一個問題。

And I'll now turn the call over to Chris.

現在我將把電話交給克里斯。

Good morning, everyone. Thank you, Tim. To have the first slide, please. So I think we've delivered a very strong third quarter. Particularly, I'm very happy to see our growth launch products, delivering year-on-year growth of 67% in the third quarter. The launch products again in this quarter, and if I look at this year-to-date as well, more than have offset the MS decline on a year-to-date basis. La Kemvi continues to show good, strong, sustained sequential global demand growth with sales globally of $121 million.

各位早安。謝謝你，提姆。請播放第一張投影片。所以我認為我們第三季表現非常出色。尤其令我非常高興的是，我們的成長型產品在第三季實現了年增 67%。本季再次推出的產品，如果我再看看今年迄今為止的情況，已經完全抵消了微軟今年迄今為止的下滑。La Kemvi 持續保持良好、強勁、持續的全球需求環比成長，全球銷售額達 1.21 億美元。

You may recall that we disclosed in the second quarter that we had increased inventory levels in China. And so we had higher Q2 sales and with some offset now in Q3 but when you look at this on a rolling 12-month basis, we're very happy with the progress we're making on Lakembe the approval of the iClick subcutaneous injection for maintenance is now approved in the US and it has rolled out and patients are benefiting from that.

您可能還記得，我們​​在第二季披露，我們增加了在中國的庫存水準。因此，我們第二季度的銷售額更高，雖然第三季度有所抵消，但從過去 12 個月的滾動數據來看，我們對 Lakembe 的進展非常滿意，用於維持治療的 iClick 皮下注射劑已在美國獲得批准，並已投入使用，患者正在從中受益。

Sky Claris is now available in 34 markets globally. We've got 30% year-over-year revenue growth. That is actually not as high as even the patient growth because we have a number of early access programs in countries making sure that patients benefit from the product while we negotiate with pricing and governments around the world. And ZURZUVAE, 150% revenue growth year-over-year. This is just an amazing product. One of the most interesting things is I think we are actually changing the perception of postpartum depression. Every day, there are media stories about this terrible condition from others. Jennifer Lawrence is the most recent person to talk about her experience with postpartum depression.

Sky Claris 目前已在全球 34 個市場上市。我們實現了30%的年收入成長。實際上，這個數字甚至沒有患者成長率那麼高，因為我們在一些國家開展了多個早期准入項目，以確保患者能夠從產品中受益，同時我們也在與世界各地的政府和定價機構進行談判。ZURZUVAE 的營收年增 150%。這真是一款令人驚豔的產品。我覺得最有趣的一點是，我們實際上正在改變人們對產後憂鬱症的看法。每天都有媒體報道其他人遭遇的這種可怕境況。珍妮佛勞倫斯是最近一位公開談論自己產後憂鬱症經歷的人。

So ZURZUVAE is not just a product. I think we are really revolutionizing how people look at this. And that's important, and it's -- but it's also driving a lot of revenue growth for us. If I look at the pipeline, again, very good strong progress. We have litifilimab Phase III studies now are fully enrolled, and both are now expected to read out in the second half of 2026.

所以 ZURZUVAE 不只是一款產品。我認為我們正在徹底改變人們看待這個問題的方式。這很重要，而且——它也為我們帶來了大量的收入成長。如果我看一下產品線，同樣，進展非常順利。目前，litifilimab 的 III 期研究已全數入組，預計兩項研究結果將於 2026 年下半年公佈。

Now I look at this as not just an acceleration. Lupus is an extremely competitive area. There are a lot of studies ongoing. And one of the things when you look commercially at a new product is, can I recruit patients in clinical trials? Because that's kind of a harbinger of how things are going to work commercially. So if we can accelerate, we can accelerate in a competitive environment that tells me that already physicians are seeing something special about litifilimab, and I'm certainly encouraged by that not just from the fact that we're going to get the data earlier.

現在我認為這不僅僅是加速。紅斑性狼瘡是一個競爭極為激烈的領域。目前有很多研究正在進行中。從商業角度看待新產品時，需要考慮的問題之一是：我能否招募病患參與臨床試驗？因為這在某種程度上預示著商業領域的發展趨勢。所以，如果我們能夠加快速度，我們就能在競爭激烈的環境中加快速度，這告訴我，醫生們已經看到了litifilimab的特殊之處，我當然對此感到鼓舞，不僅僅是因為我們將更早地獲得數據。

But as I say, I think it's a good sign for the commercial success longer term of the product. We continue to build out our early stage pipeline. As we'll see in a minute, we've got, I think, an extremely robust late-stage pipeline. Now is the time to turn to an earlier stage. We've started a Phase I study for BIIB142. It's an IRAK-4 degrader for autoimmune disease.

但正如我所說，我認為這對該產品長期的商業成功來說是一個好兆頭。我們持續拓展早期研發管線。稍後我們將看到，我認為我們擁有非常強大的後期研發管線。現在是時候回到之前的階段了。我們已啟動 BIIB142 的 I 期研究。它是一種用於治療自體免疫疾病的IRAK-4降解劑。

We actually expect to put another three to four molecules into our early-stage pipeline over the coming 18 months. And then we continue to be active on the BD side. We announced the agreement to acquire [Alceon] Therapeutics. This is a very strategic acquisition for us. ASOs continue to be a load of administration that is necessary to treat a number of diseases. We ourselves have other products such as [selinersen, B-80, zuravenersen]. And so this is a mode of administration that will be much more convenient for patients and we're seeing other companies obviously also developing ASO. So this is really going to be a breakthrough, we believe, for patients who are taking intrathecal injections.

我們預計在未來 18 個月內，將會有三到四個分子進入我們的早期研發管線。然後我們繼續在業務拓展方面保持活躍。我們宣布了收購 [Alceon] Therapeutics 的協議。這對我們來說是一項極具戰略意義的收購。ASO 仍然是治療多種疾病所必需的繁重管理工作。我們自己還有其他產品，例如[selinersen，B-80，zuravenersen]。因此，這種給藥方式對患者來說會方便得多，而且我們顯然也看到其他公司也在開發 ASO。因此，我們相信，對於接受鞘內注射的患者來說，這將是一項真正的突破。

And then we have just added the C5aR1 antagonist through our licensing agreement with (inaudible) of the nice things about immunology drugs is that they tend to offer you an opportunity to create a portfolio in a product. As you follow these immunological pathways, they can lead to a number of different indications. And the beauty of that is, of course, that once you've been able to demonstrate safety, you can then very efficiently go into other indications.

然後，我們剛剛透過與（聽不清楚）的授權協議添加了 C5aR1 拮抗劑。免疫學藥物的優點之一是，它們往往能讓你有機會在一個產品中創造產品組合。沿著這些免疫途徑發展，可能會導致多種不同的症狀。當然，這樣做的好處在於，一旦你證明了安全性，你就可以非常有效地進入其他適應症領域。

And again, we expect to announce at least another one, if not two further research stage deals by the end of the year. So if we can move to the next slide, please. Now these are -- I love this slide. When I look at this and I look at the lines that are extending all the way across the page, I mean, the company our size, 10 Phase III or Phase III-ready programs and that covers five Phase III NMEs.

我們預計到今年年底前至少還會宣布一項，甚至兩項新的研究階段交易。那麼，我們可以進入下一張投影片了。現在這些——我喜歡這張投影片。當我看到這些，看到這些橫跨整個頁面的線條時，我的意思是，像我們這樣規模的公司，有 10 個 III 期或準備進入 III 期的項目，其中 5 個是 III 期新分子實體。

And we've got a lot of conviction around this pipeline. And we've seen a lot of good data in Phase I. And we're getting close to now seeing a lot of the readouts out of that. Now one of the things that you probably don't think about is that these are not just 10 Phase III programs. This is also 10 launches. If I take just felzotimab as an example, there are four indications of that. two of those, AMR and MVI are transplant. Two of those are in nephrology. And then, of course, we've got lupus coming along with three indications in lupus.

我們對這條輸油管項目充滿信心。我們已經在第一階段看到了很多不錯的數據。現在我們即將看到很多最終結果。現在，你可能沒有想到的一件事是，這些不僅僅是 10 個第三階段專案。這也是第10次發射。以非佐替單抗為例，它有四種適應症。其中兩種，即抗體介導的排斥反應（AMR）和微血管侵犯（MVI），都與移植有關。其中兩名是腎臟科醫生。當然，還有紅斑狼瘡，紅斑狼瘡有三種適應症。

And of course, we're still in rare disease with orvanursin. We have a next generation of SPINRAZA with selinersen, and we're quite excited about what's coming along with BIIB080 in tau. But all of those require now that we start building up commercial teams building insights, thinking about pricing, thinking about value propositions. So a lot of activity going on inside the company.

當然，我們目前仍在研究奧凡諾辛治療罕見疾病的情況。我們有下一代 SPINRAZA 和 selinersen，我們對 tau 中 BIIB080 的到來感到非常興奮。但所有這些都要求我們現在開始組建商業團隊，累積洞察力，思考定價，思考價值主張。公司內部活動很多。

Another thing I'd like to look at in terms of trying to predict whether things are going to be a success or not is, can we attract strong talent. Because people bet their careers when they come to a company. and especially if it's a new product. And I have to say I've been super impressed with the talent that we've been bringing into Biogen. And that sort of says to me that people are willing to bet their careers on these exciting new products. And I have seen time and time again over my career that, that often translates into commercial success. Market research is important, but I think some of these other indicators are even more important. So we coming the next slide.

我想從另一個角度來預測事情是否會成功，那就是我們能否吸引優秀人才。因為人們加入一家公司就等於押上了自己的職業生涯，尤其是在推出新產品的時候。我必須說，我對我們為 Biogen 引進的人才印象深刻。這在我看來說明人們願意把自己的職業生涯押在這些令人興奮的新產品上。在我的職業生涯中，我一次又一次地看到，這往往會轉化為商業上的成功。市場研究固然重要，但我認為其他一些指標更為重要。接下來我們來看下一張投影片。

So what we've been trying to do over the last three years. The first is, obviously, let's grow our new product launches. And again, 67% revenue growth says this is a very strong performance. We've got with the pending Sky Claris, Jersey even (inaudible). And when I look over the last trailing 12 months, it's almost $1.2 billion in revenue. So -- and obviously, these products all have long runways in terms of market exclusivity and in each of these, these are first in first -- not only first-in-class, but first-ever treatments in these areas. So we're actually doing an awful lot of market creation. For those of you who've got a lot of commercial experience, you know that creating markets is a lot tougher than just going into established markets and taking market share.

所以，這就是我們過去三年一直在努力做的事情。首先，很顯然，我們要增加新產品的發布量。再次強調，67% 的營收成長表明，這是一個非常強勁的業績。我們已經和即將推出的 Sky Claris 以及 Jersey 合作了。（聽不清楚）回顧過去 12 個月，收入接近 12 億美元。所以——顯然，這些產品在市場獨佔方面都有很長的期限，而且在每一種產品中，它們都是首創——不僅是同類首創，而且是這些領域有史以來的首創療法。所以，我們實際上做了很多市場創造工作。對於那些擁有豐富商業經驗的人來說，你們都知道，創造市場比進入現有市場並搶佔市場份額要困難得多。

And I think that speaks to a lot of the commercial strength of our teams at Biogen. Then let's look at the profitability of our legacy business. And yes, I think we beat on the top line this quarter because of MS. But that's not all by accident. And I think we are beating just about every analog when you're looking at products that have come to the end of their market exclusivity periods. I think that speaks to the strong customer care. I think it speaks to the strong loyalty of patients to Biogen's product. We are still the company that treats more patients with MS than any other company out there. And one of the things that we shouldn't forget is it's not all legacy.

我認為這充分體現了百健團隊的商業實力。接下來，我們來看看我們原有業務的獲利能力。是的，我認為我們本季營收超預期是因為微軟的貢獻。但這並非完全是偶然。我認為，在那些市場獨佔期結束後的產品中，我們幾乎擊敗了所有同類產品。我認為這體現了他們對客戶的重視。我認為這反映了患者對渤健產品的強烈忠誠度。我們仍然是治療多發性硬化症患者最多的公司。我們不該忘記的一點是，這一切並非全是傳承。

There's an amazing product out there called VUMERITY that has been growing very strongly this year. It's almost $0.5 billion sales in the first nine months of this year. And this is a product that has market exclusivity well beyond the end of the decade. And very proud to see particularly our US team investing more into this business and that is responding well. And it is really the only patent protected product still in the oral segment, which is extremely important part of the MS market. And then we've been very conscious of being efficient. We are going to deliver this $1 billion of gross savings. We were clear right from the get-go that we would be investing some of that as part of the launch in our new products, but also in research and development.

市面上有一款名為 VUMERITY 的出色產品，今年的成長動能非常強勁。今年前九個月的銷售額接近 5 億美元。而且，該產品的市場獨家銷售權將持續到本世紀末以後。尤其令我感到自豪的是，我們的美國團隊加大了對這項業務的投入，並且取得了良好的成效。而且它是目前口服領域唯一仍在專利保護的產品，而口服領域是 MS 市場中極為重要的部分。而且我們一直都非常注重效率。我們將實現這10億美元的毛節省額。從一開始我們就明確表示，我們將把其中一部分資金投入到新產品的發布中，同時也投入研發。

You've seen our revenue growing, but our OpEx growth was still flat over this year. Despite a lot of new investments, we have added products to our late-stage development and we are doing all of this recruitment for the commercial preparation of all these launches that are now in Phase II. And then obviously, if I look at our pipeline, we have cut development costs by almost 25% and research by 40% and I would argue that we have a stronger pipeline than we did before. And that's really a lot of what Priya has done in terms of being very careful about which products we put into development, building conviction behind those. I think as I look at the pipeline, I'd say we've got a very exciting and a high conviction late-stage pipeline.

你們已經看到我們的收入正在成長，但今年我們的營運支出成長仍然停滯不前。儘管我們投入了大量新資金，但我們已將產品添加到後期開發階段，並且我們正在進行所有這些招聘工作，為所有這些目前處於 II 期的上市進行商業準備。顯然，如果我看一下我們的產品線，我們已經削減了近 25% 的開發成本和 40% 的研究成本，我認為我們現在的產品線比以前更強大了。Priya 在這方面做了很多工作，她非常謹慎地選擇我們投入研發的產品，並對這些產品充滿信心。我認為，從產品線來看，我們擁有非常令人興奮且極具信心的後期研發產品線。

One of the reasons that we're doing these early-stage deals is, I think we now need to build an early-stage pipeline and Vanquis is just one example of that. We continue to generate strong cash flow, and we continue to look at where are the opportunities across the entire spectrum about how we can grow our business. I think we are very disciplined about where we put that cash flow. Everything that we want to invest in has to be something that contributes to growth. And so with that, perhaps we can learn a little bit more about our pipeline.

我認為，我們進行這些早期交易的原因之一是，我們現在需要建立一個早期投資管道，而 Vanquis 就是其中的一個例子。我們持續創造強勁的現金流，並持續在各個領域尋找發展業務的機會。我認為我們在現金流的運用上非常有紀律。我們想要投資的一切都必須是能夠促進成長的。因此，透過這些訊息，或許我們可以對我們的管道有更多了解。

And I'll pass it over to Priya.

然後我把它交給普里亞。

Thank you, Chris. This year, we've made important progress across the development pipeline and we are positioned to continue to deliver multiple expected milestones over the next 18 months. As Chris noted, we remain focused on execution against our strategic objectives. And there are a few achievements I'd like to highlight from this quarter.

謝謝你，克里斯。今年，我們在研發流程的各個環節都取得了重要進展，我們有能力在未來 18 個月內繼續實現多個預期里程碑。正如克里斯所指出的，我們將繼續專注於執行我們的策略目標。我想重點介紹本季取得的一些成就。

Importantly, as Chris mentioned, despite competitive recruitment for trials in the space, we have now fully enrolled both TOPAS studies for litifilimab in SLE. This allows us to now pull forward both expected readouts from these studies into next year 2026. Next, we continue to advance to exciting new opportunities. First, with Sallaersin where the pivotal study design for presymptomatic infants and the broader clinical development plan has been aligned with the FDA.

重要的是，正如 Chris 所提到的，儘管該領域的試驗招募競爭激烈，但我們現在已經完成了針對 SLE 的 litifilimab 的兩項 TOPAS 研究的全部招募工作。這樣一來，我們現在可以將這兩項研究的預期結果提前到明年 2026 年公佈。接下來，我們將繼續邁向令人興奮的新機會。首先是 Sallaersin，針對無症狀嬰兒的關鍵性研究設計以及更廣泛的臨床開發計劃已與 FDA 保持一致。

We are also engaging with ex US regulators and expect to initiate the registrational study in early 2026. We also continue to advance (inaudible) in late MVI, where we expect to initiate a potential registrational trial in coming months. And today, we announced an update on high dose SPINRAZA, where the FDA provided us with a path forward we resubmitted promptly, and now we have a PDUFA in April 2026. Over the last few years, we have transformed both our late-stage and early-stage pipeline. We have followed the science and secured proof of concept to advance high scientific connection assets into potentially registrational stages. And as we prosecute the early-stage assets, we continue to follow the science by testing the most important scientific hypothesis.

我們目前也正在與美國前監管機構接洽，預計 2026 年初啟動註冊研究。我們也在後期 MVI 領域繼續取得進展（聽不清楚），我們預計將在未來幾個月內啟動一項潛在的註冊試驗。今天，我們宣布了高劑量 SPINRAZA 的最新進展，FDA 為我們提供了前進的方向，我們迅速重新提交了申請，現在我們已獲得 2026 年 4 月的 PDUFA 批准。過去幾年，我們對後期和早期研發管線都進行了改革。我們遵循科學原理，並獲得了概念驗證，從而將具有高度科學關聯性的資產推進到潛在的註冊階段。在推動早期資產投資的過程中，我們始終遵循科學，檢驗最重要的科學假設。

We now expect to deliver several readouts from our pre-POC pipeline next year. We're also focused on broadening the pre-POC pipeline, both with internal research assets that we advanced to IND stage like with 142 (inaudible) and by also remaining deeply engaged in targeting external innovation, including our announcement last week, as Chris mentioned, to collaborate with Banco Bio on clinical one antagonist.

我們現在預計明年將公佈我們預 POC 流程的幾項讀數。我們也專注於擴大 POC 前的研發管線，一方面透過推進到 IND 階段的內部研究資產（如 142 號化合物），另一方面也積極尋求外部創新，包括我們上周宣布的與 Banco Bio 合作開發臨床一號拮抗劑（正如 Chris 所提到的）。

Turning to our late-stage pipeline. I'm encouraged by the breadth of opportunities to further scientifically advance our assets including our ability to educate on the profile of our innovative medicines with our data. For example, this week at ACR we presented important differentiated data from our positive Phase III DAPI trial, showing a consistent clinically meaningful benefit across outcomes that are relevant for SLE patients and providers such as flare reduction, fatigue, morning stiffness, musculoskeletal pain, LL DAS as well as remission.

接下來，我們來看看後期研發管線。令我感到鼓舞的是，我們有很多機會可以進一步從科學角度推進我們的資產，包括利用我們的數據來宣傳我們創新藥物的特徵。例如，本週在 ACR 會議上，我們展示了來自我們積極的 III 期 DAPI 試驗的重要差異化數據，顯示在與 SLE 患者和醫療服務提供者相關的結果中，如病情加重減少、疲勞、晨僵、肌肉骨骼疼痛、LL DAS 以及緩解，均顯示出持續的、具有臨床意義的益處。

And underscoring our comments that we made at our September lupus seminar on the potential importance of gaping for patients with SLE, including women of childbearing age we presented data demonstrating limited placental transfer in a preclinical setting. Next, I would like to spend a few minutes on the continued LEQEMBI development to deliver optionality for Alzheimer's disease patients.

為了強調我們在 9 月的狼瘡研討會上提出的 SLE 患者（包括育齡婦女）胎盤擴張的潛在重要性的評論，我們展示了在臨床前環境中胎盤轉運有限的數據。接下來，我想花幾分鐘時間談談 LEQEMBI 的持續開發，它為阿茲海默症患者提供了更多選擇。

As you can see on the left side of this slide, we have already been successful this year in delivering meaningful differentiated treatment options for LEQEMBI. Today, it is the only anti-amyloid therapy with a maintenance option as well as an at-home subcutaneous maintenance action. And we continue to advance our rolling submission to the FDA for LEQEMBI subcutaneous initiation. The option for maintenance and the availability of subcutaneous delivery are also potentially relevant to Legend in the presymptomatic AD population. The AHEAD 3-45 study, as you can see here, is an important study that aims to comprehensively evaluate Legend in two different stages of presymptomatic AD with the appropriate scientific questions and the relevant primary endpoints.

正如您在這張投影片的左側所看到的，今年我們已經成功地為 LEQEMBI 提供了有意義的差異化治療方案。目前，它是唯一一種既有維持治療方案又有居家皮下維持治療方案的抗澱粉樣蛋白療法。我們將繼續推進向 FDA 提交 LEQEMBI 皮下注射起始治療的滾動申請。對於無症狀 AD 族群而言，維持治療的選擇以及皮下給藥的可行性也可能與 Legend 相關。如您所見，AHEAD 3-45 研究是一項重要的研究，旨在透過適當的科學問題和相關的主要終點，全面評估 Legend 在 AD 症狀前兩個不同階段的療效。

Additionally, we have seen increasing momentum in the development, approval and utilization of blood-based biomarkers. We see this as a key enabler that potentially simplifies the diagnostic pathways. We remain excited and believe the potential for LEQEMBI in the presymptomatic AD population can be an important opportunity for Biogen. In closing, I'm encouraged that LEQEMBI ahead 345 is just one of several important registrational readouts we have over the next few years.

此外，我們還看到血液生物標誌物的開發、批准和利用勢頭日益強勁。我們認為這是一項關鍵的推動因素，有可能簡化診斷流程。我們仍然感到興奮，並相信 LEQEMBI 在無症狀 AD 族群中的潛力對 Biogen 來說可能是一個重要的機會。最後，我感到鼓舞的是，LEQEMBI 345 只是我們在未來幾年內將要公佈的幾個重要註冊結果之一。

As you can see on this slide, our high scientific conviction pipeline will play a critical role given the increasing momentum in our registrational data flow. This will begin with two litifilimab Phase III readouts in SLE next year, and 2027 onwards, we will see multiple registrational readouts across several assets in diverse and important therapeutic areas.

正如您在這張投影片中所看到的，鑑於我們註冊資料流的勢頭日益強勁，我們高科學信念的流程將發揮關鍵作用。明年將首先公佈兩項 litifilimab 在系統性紅斑狼瘡 (SLE) 中的 III 期臨床試驗結果，從 2027 年開始，我們將看到多個資產在不同重要治療領域獲得多項註冊性結果。

With that, I would now like to hand the call over to Alisha for an update on our commercial business.

接下來，我想把電話交給艾莉莎，請她回報我們商業業務的最新情況。

Thank you, Priya and good morning, everyone. Today, I'll review the commercial results we achieved in Q3, beginning with our multiple sclerosis portfolio. Our MS business continues to deliver significant revenue, which provides the resources to invest in our growth products, advance our pipeline and achieve our vision for the new Biogen. In the US, we saw strong performance, mainly driven by strategic actions to support VUMERITY's growth and some onetime events.

謝謝你，Priya，大家早安。今天，我將回顧我們在第三季的商業成果，首先從我們的多發性硬化症產品組合開始。我們的 MS 業務持續帶來可觀的收入，這為我們投資成長型產品、推進產品線以及實現我們對新 Biogen 的願景提供了資源。在美國，我們看到了強勁的業績，這主要得益於支持 VUMERITY 成長的策略舉措和一些一次性事件。

When we look at competitive dynamics globally, we are seeing increased impact of TECFIDERA generics in Europe. And for Tysabri, we believe we are well prepared for our biosimilar entrant in the US. Now turning to LEQEMBI, which delivered another strong quarter with global revenues growing 82% compared with Q3 2024, underscoring its increasing impact on the Alzheimer's community worldwide.

從全球競爭格局來看，TECFIDERA仿製藥在歐洲的影響力日益增強。對於泰沙布里，我們相信我們已經為在美國推出生物相似藥做好了充分準備。現在來看看 LEQEMBI，該公司又迎來了一個強勁的季度，全球收入與 2024 年第三季度相比增長了 82%，凸顯了其對全球阿茲海默症患者群體日益增長的影響。

In the US, our team is working collaboratively with Eisai driving strong execution and customer engagement, which we believe supported our prescriber base growing another 14% quarter-over-quarter. This quarter, we sustained consistent growth of new writers and new patients and LEQEMBI holds majority share as the number one prescribed anti-amyloid treatment. Throughout 2025, we estimate LEQEMBI captured roughly half of all the new patients treated with anti-amyloid therapies.

在美國，我們的團隊正與衛材公司密切合作，推動強有力的執行和客戶互動，我們相信這有助於我們的處方醫生群體環比增長 14%。本季度，我們持續保持新作者和新患者的成長，LEQEMBI 作為處方量第一的抗澱粉樣蛋白治療藥物，佔據了大部分市場份額。我們估計，到 2025 年，LEQEMBI 將涵蓋所有接受抗澱粉樣蛋白療法治療的新患者中的大約一半。

Now with the launch of iClick subcutaneous auto-injector for maintenance LEQEMBI is the first and only anti-amyloid treatment to offer an at-home injection, giving physicians, patients and care partners more options to continue to slow disease progression following the 18-month initial treatment period. Early feedback from customers and payers has been positive. And into next year, we will remain focused on securing Part D coverage and supporting patient access to LEQEMBI.

現在，隨著用於維持治療的 iClick 皮下自動注射器的推出，LEQEMBI 成為第一個也是唯一一個提供居家注射的抗澱粉樣蛋白治療藥物，為醫生、患者和護理人員提供了更多選擇，以便在 18 個月的初始治療期結束後繼續減緩疾病進展。來自客戶和付款方的早期回饋都很積極。進入明年，我們將繼續專注於確保D部分保險覆蓋範圍，並支持患者獲得LEQEMBI治療。

Last quarter, we noted that for the first time we observed early signals indicating the anti-amyloid market grew with two players. We are encouraged that this quarter, our data shows the market continued to grow by approximately 15%. We also shared that blood-based biomarker testing was advancing at a significant pace. And here, our physicians have pointed to a meaningful impact.

上個季度，我們注意到，我們首次觀察到早期跡象表明，抗澱粉樣蛋白市場由兩家公司主導成長。我們感到鼓舞的是，本季數據顯示市場持續成長約 15%。我們也提到，基於血液的生物標記檢測正在快速發展。而在這裡，我們的醫生指出了其產生的重要影響。

They report blood tests to help move from probable to definitive diagnosis more quickly, enabling HCPs, patients and their families to focus more on the treatment discussion. We anticipate up to 350,000 Alzheimer's blood tests this year and more than 60,000 PET scans to date, which is a 75% increase compared to this time last year. Our data show early indicators that PET, CSF positive tests are increasing, which we believe may be attributable to increasing use of Alzheimer's blood diagnostics as a triaging tool. As we previously noted, we are educating HCPs about the quality of blood-based biomarkers, including the performance of BBM and that meet the requirements of the Alzheimer's Association's new practice guidelines for amyloid triage and confirmation.

他們報告血液檢測結果，以幫助更快地從疑似診斷過渡到確診診斷，使醫護人員、患者及其家人能夠更專注於治療討論。我們預計今年將進行多達 35 萬次阿茲海默症血液檢測，迄今將進行超過 6 萬次 PET 掃描，與去年同期相比成長 75%。我們的數據顯示，PET、CSF陽性檢測結果呈上升趨勢，我們認為這可能是由於阿茲海默症血液診斷作為分診工具的使用日益增多所致。正如我們之前提到的，我們正在向醫療保健專業人員普及血液生物標記的質量，包括 BBM 的性能，以及符合阿茲海默症協會關於澱粉樣蛋白分診和確認的新實踐指南的要求。

As we look to 2026, we expect LEQEMBI's momentum will continue to be driven by our focused strategies, which we believe are already having a positive impact on intent to prescribe perceptions of efficacy and safety and health care providers' understanding of the role of anti-amyloid therapies. Moving on to Sky Claris, where the launch continues to drive patient growth across all regions, including the US and overseas.

展望 2026 年，我們預計 LEQEMBI 的發展勢頭將繼續由我們專注的策略推動，我們相信這些策略已經對處方意願、對療效和安全性的看法以及醫療保健提供者對抗澱粉樣蛋白療法的作用的理解產生了積極影響。接下來是 Sky Claris，該產品的上市持續推動著包括美國和海外在內的所有地區的患者數量成長。

Sky Claris is now available in 34 countries, contributing to strong growth of 30% and compared to the same time last year. In the US, as expected, patients continue to grow quarter-over-quarter with quarter three revenue being impacted by channel mix in the context of the IRA changes to Medicare. As we shared in the past, our strategy in the US is to reach the remaining Friedreich ataxia patients, their neurologists and PCPs, which our data indicate are primarily based in the community.

Sky Claris 目前已在 34 個國家/地區上市，與去年同期相比實現了 30% 的強勁成長。正如預期的那樣，在美國，患者數量繼續逐季增長，第三季度收入受到 Medicare 的 IRA 改革背景下的管道組合的影響。正如我們過去所分享的，我們在美國的策略是接觸到剩餘的弗里德賴希共濟失調患者、他們的神經科醫生和初級保健醫生，我們的數據顯示，他們主要居住在社區。

Our efforts are focused on delivering on the school as nearly two-thirds of new patients in Q3 were prescribed by first-time writers and roughly a quarter of new scripts were written by PCPs. Outside the US, we remain focused on continued geographic expansion with multiple commercial launches planned in the first half of 2026.

我們正努力實現學校的目標，因為第三季近三分之二的新患者是由首次開處方的醫生開的藥，大約四分之一的新處方是由初級保健醫生開的。在美國以外，我們將繼續專注於地理擴張，並計劃在 2026 年上半年進行多次商業發布。

Last, turning to ZURZUVAE, which continues to perform above our expectations. As we shared earlier this year, our expanded field team has had a meaningful impact, delivering $55 million in the US, which is a 19% revenue growth compared to last quarter. We are also encouraged by the increasing breadth of writers, which grew 19% quarter-over-quarter.

最後，讓我們來看看 ZURZUVAE，它的表現繼續超出我們的預期。正如我們今年稍早分享的那樣，我們擴大的現場團隊已經產生了顯著的影響，在美國實現了 5,500 萬美元的收入，與上一季相比成長了 19%。我們也欣喜地看到作者群體日益擴大，季增了 19%。

And in quarter three, of ZURZUVAE prescriptions were written as first line, demonstrating health care providers' belief in the value of therapy that provides rapid relief to mothers impacted by postponing depression. Across our portfolio, I am proud of our teams for executing with discipline and delivering on our strategic priorities. Their hard work is helping us serve patient communities, build new markets and drive sustainable growth.

第三季度，ZURZUVAE 處方中有 100% 被作為第一線藥物開出，這表明醫療保健提供者相信這種療法的價值，它可以為受憂鬱症影響的母親提供快速緩解。在我們的所有業務中，我為我們的團隊感到自豪，他們執行嚴謹，並實現了我們的策略重點。他們的辛勤工作幫助我們服務患者群體，開拓新市場，並推動永續成長。

I will now turn it over to Robin for an update on our financial results.

現在我將把發言權交給羅賓，請他報告我們的財務表現。

Thank you, Alisha. I would like to provide some key highlights about our strong third quarter financial results. Unless otherwise noted, each of the comparisons I make during my remarks are versus the third quarter of 2024. We delivered 3% revenue growth this quarter, driven by continued strong commercial execution. Our four launch products generated $257 million in revenue in the quarter, representing a 67% growth.

謝謝你，艾莉莎。我想重點介紹一下我們強勁的第三季財務業績。除非另有說明，我在發言中所做的每一項比較都是與 2024 年第三季進行比較。本季我們實現了 3% 的營收成長，這主要得益於持續強勁的商業執行力。本季度，我們推出的四款產品創造了 2.57 億美元的收入，年增 67%。

We continue to see resilient performance from our US MS business which was favorably impacted by gross to net adjustments, timing of shipments and strong demand growth for VUMERITY. This was partially offset by continued generic erosion of TECFIDERA in Europe. Notably, the year-to-date cumulative revenue from our launch products has more than offset the year-to-date decline in our MS product revenue.

我們的美國 MS 業務持續保持穩健的業績，這得益於毛利淨額調整、出貨時間以及 VUMERITY 的強勁需求成長。TECFIDERA 在歐洲持續的仿製藥侵蝕部分抵消了這種影響。值得注意的是，我們首發產品的年初至今累計收入已經超過了我們 MS 產品收入年初至今的下降幅度。

This commercial execution, combined with our disciplined operating expense management resulted in non-GAAP diluted EPS growth of 18% for the quarter. We also delivered $1.2 billion of free cash flow in the quarter. Turning to our guidance. I'm encouraged by the strong business trends that we continue to observe in Q3. This is reflected in our improved revenue outlook. You'll note that our non-GAAP EPS outlook has been updated to reflect that stronger business outlook while adjusting for expected business development activities that are expected to close in the fourth quarter.

這種商業執行，加上我們嚴格的營運費用管理，使得本季非GAAP稀釋後每股收益成長了18%。本季我們也實現了12億美元的自由現金流。請參考我們的指導意見。第三季我們持續觀察到的強勁業務趨勢令我感到鼓舞。這體現在我們改善後的收入預期。您會注意到，我們的非GAAP每股收益預期已更新，以反映更強勁的業務前景，同時調整預計在第四季度完成的預期業務發展活動。

I will provide more details on this in a moment. Let me cover some key components of our Q3 revenue performance. Starting with our MS franchise. In addition to the strong commercial execution that Alisha discussed, the Merit benefited from approximately $22 million of favorable inventory dynamics. And overall, USS benefited from favorable gross to net adjustments of $38 million in the quarter. Outside of the US, sales were primarily impacted by expected generic pressures for TECFIDERA. We continue to defend our IP. However, we observed an acceleration of erosion, particularly in Europe as generics continue to launch in new geographies, including Germany.

我稍後會提供更多細節。讓我來介紹一下我們第三季營收表現的一些關鍵組成部分。從我們的微軟特許經營開始。除了艾莉莎提到的強勁的商業執行力之外，美瑞特還受益於約 2,200 萬美元的有利庫存動態。總體而言，USS 在本季受益於毛利淨額調整 3,800 萬美元。在美國以外，TECFIDERA 的銷售主要受到預期仿製藥壓力的影響。我們將繼續捍衛我們的智慧財產權。然而，我們觀察到侵蝕現象正在加速，尤其是在歐洲，因為仿製藥不斷在新地區（包括德國）推出。

This, combined with the channel dynamics, resulted in a sequential net decrease in TECFIDERA revenue of $28 million versus the prior quarter in Europe. On a positive note, year-over-year and quarter-over-quarter impact of the Tysabri IV biosimilar in Europe was roughly offset by growing demand for our subcutaneous formulation, which has no biosimilar alternative and now accounts for more than 50% of all branded and biosimilar natalizumab patients in Europe.

再加上通路動態的變化，導致 TECFIDERA 在歐洲的收入季淨減少 2,800 萬美元。從積極的方面來看，Tysabri IV 生物相似藥在歐洲的同比和環比影響大致被我們皮下製劑需求的增長所抵消，該製劑目前沒有生物類似藥替代品，並且現在佔歐洲所有品牌和生物類似藥那他珠單抗患者的 50% 以上。

For SPINRAZA, we continue to be encouraged by the consistency and demand globally. And as expected, ex US SPINRAZA was impacted by the drawdown of the inventory build from the first quarter. We continue to expect full year global SPINRAZA revenue to be relatively similar in 2025 as compared to 2024. Turning to our launch products, starting with LEQEMBI.

對於 SPINRAZA 而言，我們持續受到全球市場穩定需求的鼓舞。正如預期的那樣，除美國以外，SPINRAZA 的業績受到了第一季庫存增加減少的影響。我們仍然預計 2025 年 SPINRAZA 全球全年營收將與 2024 年基本持平。接下來介紹我們的首發產品，首先是 LEQEMBI。

We continue to see steady sequential demand growth globally with third quarter end market sales booked by ASI of approximately $121 million. As you will recall, we had a $35 million inventory build in China in the prior quarter, representing roughly six months in demand in the region. Approximately half of this build was drawn down in Q3. Therefore, as expected, there were negligible sales recognized for China in Q3 as demand was satisfied with the inventory in the channel. We continue to expect demand in China in Q4 to be satisfied with this remaining inventory with minimal revenue generated in the fourth quarter.

全球需求持續穩定成長，ASI 第三季終端市場銷售額約為 1.21 億美元。您可能還記得，上個季度我們在中國建立了價值 3500 萬美元的庫存，這相當於該地區大約六個月的需求。大約一半的建設項目在第三季被削減。因此，正如預期的那樣，第三季度中國市場的銷售額微乎其微，因為通路庫存已經滿足了需求。我們仍預期第四季中國市場的需求將由剩餘庫存滿足，第四季產生的收入將微乎其微。

Zyclara saw continued growth globally with revenue increasing 30% from this time last year. In the US, continued sequential patient growth was offset by approximately adjustment related to channel mix in the context of the IRA redesign related to Medicare. We expect Sky Claris to continue to grow, and we are working to secure reimbursement in certain European markets as well as in Latin America.

Zyclara在全球持續成長，營收比去年同期成長了30%。在美國，患者數量的持續成長被與醫療保險相關的 IRA 重新設計背景下的通路組合調整所抵消。我們預計 Sky Claris 將繼續成長，我們正在努力確保在某些歐洲市場以及拉丁美洲獲得報銷。

As Alisha noted, we are pleased to see continued strong growth for ZURZUVAE driven by increased demand. Now a few comments on the rest of the P&L. Before I get into the quarterly dynamics, I would like to highlight the variance shown here between GAAP and non-GAAP cost of sales. GAAP cost of sales was $674 million, up 6% year-over-year due to an approximately $100 million pretax charge accrued in Q3 that related to a judgment on Genentech's claim for past royalties and interest related to TYSABRI.

正如 Alisha 指出的那樣，我們很高興看到 ZURZUVAE 在需求成長的推動下繼續保持強勁成長。現在就對損益表的其餘部分做一些說明。在深入探討季度動態之前，我想重點指出這裡顯示的 GAAP 和非 GAAP 銷售成本之間的差異。GAAP 銷售成本為 6.74 億美元，年增 6%，原因是第三季提列了約 1 億美元的稅前費用，該費用與 Genentech 就 TYSABRI 過去特許權使用費和利息提出的索賠判決有關。

Without this impact, it would have been approximately $570 million, representing an 11% decrease year-over-year. More broadly, cost of sales benefited from favorable product mix from lower contract manufacturing revenue in Q3 2025, which has a lower margin. This trend is expected to continue through the remainder of the year due to the planned campaign timing of contract manufacturing that we have previously discussed.

如果沒有這項影響，金額將約為 5.7 億美元，比去年同期減少 11%。更廣泛地說，由於 2025 年第三季合約製造收入下降（利潤率較低），銷售成本受益於有利的產品組合。由於我們之前討論過的合約製造計劃活動時間安排，預計這一趨勢將在今年剩餘時間內持續下去。

Non-GAAP core operating expense or R&D plus SG&A expense is flat year-over-year. What's evident in our results is that we remain disciplined in our cost management as we continued to deliver on our R&D prioritization and Fit for Growth initiatives, while ensuring that we are supporting investments in our launch products and long-term growth potential.

非GAAP核心營運費用或研發費用加上銷售、一般及行政費用與前一年持平。從我們的業績可以看出，我們在成本管理方面保持了嚴格的紀律，同時繼續推進研發優先事項和「適合成長」計劃，並確保我們支持對上市產品和長期成長潛力的投資。

Now I'd like to provide a brief update on our balance sheet. This quarter, we generated approximately $1.2 billion of free cash flow due to business performance and continued cost management discipline. We exited the quarter with $4 billion in cash and marketable securities, and $2.3 billion of net debt.

現在我想簡單介紹一下我們的資產負債表狀況。本季度，由於業務表現和持續的成本管理，我們產生了約 12 億美元的自由現金流。本季末，我們擁有 40 億美元的現金和有價證券，淨債務為 23 億美元。

Our financial strength gives us the flexibility to reinvest in strategic growth initiatives, including advancing our pipeline, supporting product launches and exploring growth opportunities as we work to deliver the new Biogen. Turning now to guidance. We have updated our non-GAAP EPS guidance to reflect a stronger underlying business outlook and investment for growth from business development transactions expected to close in the fourth quarter.

我們的財務實力使我們能夠靈活地將資金再投資於策略性成長計劃，包括推進我們的產品線、支援產品上市以及探索成長機會，從而努力實現新的百健。現在進入指導環節。我們已更新了非GAAP每股收益預期，以反映更強勁的潛在業務前景以及預計在第四季度完成的業務發展交易帶來的成長投資。

As you know, the SEC requires inclusion of acquired IP R&D charges associated with business development transactions and GAAP and non-GAAP financial results. As since these onetime charges, our business outlook has continued to strengthen in the quarter, yielding a $0.25 per share improvement. Our updated full year guidance includes an approximately $1.25 per share impact for business development transactions that we expect to close during the fourth quarter including the license agreement with Sana Bio and the acquisition of Alceon Therapeutics. The following are some key considerations underlying our financial guidance.

如您所知，美國證券交易委員會要求將與業務發展交易相關的收購智慧財產權研發費用計入GAAP和非GAAP財務績效。自從這些一次性費用計入以來，本季我們的業務前景持續走強，每股收益提高了 0.25 美元。我們更新後的全年業績預期包括預計在第四季度完成的業務發展交易（包括與 Sana Bio 的授權協議和 Alceon Therapeutics 的收購）將對每股收益產生約 1.25 美元的影響。以下是我們財務指導背後的一些關鍵考慮因素。

We expect sales to be roughly flat to up 1% as compared to last year at constant currency, an improvement from our last guidance update in July. This reflects strong business performance, including the resilient performance of the US MS business year-to-date. We also expect increased competitive pressures on the ex US MS business to accelerate, particularly for TECFIDERA in Europe, where we expect the sequential impact in Q4 to be roughly double the erosion we saw this quarter.

我們預計，以固定匯率計算，銷售額將與去年持平或成長 1%，比我們 7 月的上次預期有所改善。這反映了強勁的業務表現，包括美國微軟業務今年迄今的穩健表現。我們也預計，除美國以外的MS業務將面臨越來越大的競爭壓力，尤其是歐洲的TECFIDERA，我們預計第四季的環比影響將比本季的侵蝕程度高出近一倍。

In addition, as we discussed into July, we are investing to support exciting new pipeline expansion opportunities, including a new program for felzartamab and MDI and the salanersen Phase III study discussed by Priya earlier in the call. As discussed earlier in the call, we are also beginning to invest in prelaunch activities for our late-stage high conviction pipeline and key initiatives such as direct-to-consumer advertising in support of our launch products.

此外，正如我們在 7 月討論的那樣，我們正在投資以支持令人興奮的新產品線擴展機會，包括 felzartamab 和 MDI 的新項目以及 Priya 在電話會議早些時候討論的 salanersen III 期研究。正如先前在電話會議中討論的那樣，我們也開始投資於後期高信心產品線的上市前活動，以及支持我們上市產品的關鍵舉措，例如直接面向消費者的廣告。

We believe these investments position us to drive future growth while delivering innovative solutions for patients. As we look ahead to the fourth quarter, we expect operating expenses will be approximately $1.1 billion. This reflects the typical seasonality of our Q4 spending, our ongoing investments to drive growth and our focus on cost efficiency. It also reflects the progress we've made in our pipeline with the opportunity to invest in 10 programs, either in Phase III or expected to start Phase III in the coming months. We are encouraged by our progress towards delivering the new Biogen, and we believe it's important to make these investments as we work toward our goal of sustainable growth and long-term value to shareholders.

我們相信這些投資將使我們能夠推動未來的成長，同時為患者提供創新的解決方案。展望第四季度，我們預計營運支出約為 11 億美元。這反映了我們第四季度支出的典型季節性、我們為推動成長而進行的持續投資以及我們對成本效益的關注。這也反映了我們在研發管線方面取得的進展，我們有機會投資 10 個項目，這些項目要么處於 III 期，要么預計將在未來幾個月內開始 III 期。我們對新 Biogen 的進展感到鼓舞，我們認為，在我們努力實現永續成長和為股東創造長期價值的目標的過程中，進行這些投資非常重要。

Importantly, we believe we remain on track to deliver the $1 billion of gross savings and $800 million of net savings projected under the Fit for Growth initiative by the end of 2025. And as I have mentioned previously, we expect contract manufacturing revenue in Q4 this year to be $10 million to $20 million due to planned timing of contract manufacturing batches versus Biogen innovator product manufacturing. Please be sure to review this slide and our press release for other important guidance assumptions.

重要的是，我們相信我們仍有望在 2025 年底前實現「適合成長」計畫預計的 10 億美元毛節省和 8 億美元淨節省。正如我之前提到的，由於合約生產批次的規劃時間與 Biogen 創新產品生產的時間安排不同，我們預計今年第四季的合約生產收入將達到 1000 萬美元至 2000 萬美元。請務必查看此投影片和我們的新聞稿，以了解其他重要的指導性假設。

And with that, I will pass the call back to Tim to open up questions

接下來，我將把電話轉回給提姆，讓他開始提問。

Thanks, Robin. Cindy, could we go to our first question, please?

謝謝你，羅賓。辛迪，我們能進入第一個問題嗎？

(Operator Instructions)

（操作說明）

Umer Raffat, Evercore.

Umer Raffat，Evercore。

I wanted to spend a quick second on [VOC] trial, if I may. And my question is, in a scenario where we do see a trend, how do you see that impacting the LEQEMBI franchise? And even more importantly, how does that change your thought process around the portfolio offering you have in the space? Would you need to have a Glip collaboration or an asset in-house in a scenario like that?

如果可以的話，我想花一點時間簡單談談[VOC]的試用情況。我的問題是，如果出現某種趨勢，您認為這會對 LEQEMBI 特許經營權產生什麼影響？更重要的是，這會如何改變你對該領域產品組合的思考過程？在這種情況下，您需要與 Glip 進行協作，還是需要公司內部的資源？

Well, I think on the study, let's see what the results are and where that's going to affect. We've looked at that. I think if it is positive, we do think it's probably going to be more used in the primary care setting at an earlier stage. We'll have to see what the -- again, what the results are, but it doesn't seem like this would actually affect the amount of plaque I do think, as a company, though, we are interested in having a full portfolio of products to achieve Alzheimer's. We have the VIVA program. And obviously, working on brain-shattle technology so I think we would probably evaluate that as and when the data are available. There's certainly no lack of GLP-1s out there.

嗯，我覺得關於這項研究，讓我們看看結果如何，以及它會產生哪些影響。我們已經研究過了。我認為如果結果是正面的，我們認為它可能會在基層醫療機構中更早得到更廣泛的應用。我們得看看結果如何，但就我看來，這似乎不會真正影響斑塊的數量。不過，作為一家公司，我們確實有興趣擁有完整的產品組合來實現阿茲海默症的目標。我們有VIVA專案。顯然，我們正在研究腦震盪技術，所以我認為我們可能會在數據可用時對其進行評估。市面上絕對不缺乏 GLP-1 類藥物。

I can just add that I think what's really important here is that they are hypothesizing that neuro inflammation will play an important role. And as Chris mentioned, I think that it doesn't really target the pathology. The important thing is that the EVOKE trials included patients on stable doses of Alzheimer's treatment, including the anti-amyloid antibodies. So we'll be interested in seeing that data. And what we also believe is that it will increase the awareness of the disease and the need for treating disease early.

我只想補充一點，我認為這裡真正重要的是，他們假設神經發炎將發揮重要作用。正如克里斯提到的那樣，我認為它並沒有真正針對病理。重要的是，EVOKE 試驗納入了接受穩定劑量阿茲海默症治療的患者，包括抗澱粉樣蛋白抗體。所以我們會很想看看這些數據。我們也相信，這將提高人們對這種疾病的認識，以及對早期治療這種疾病的必要性的認識。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO資本市場。

Can you step back, I'm really struck by your progress in immunology. Can you just talk to me about how this renewed focus can drive growth and pipeline expansion into the end of the decade? And what can you do with Biogen to accelerate some of these programs?

你能退後一步嗎？我真的被你在免疫學領域的進展所震撼。您能否談談這種重新聚焦如何在本十年末推動成長和產品線擴張？那麼，您能與 Biogen 合作，加速推進其中的一些專案呢？

So maybe I'll start. When I came to Biogen, I argue that we've always been immunology because basically a lot of diseases like MS, we are treating by really trying to have an impact on the immune system. As I pointed out, our MS drugs don't even cross the blood brain barrier. So I would argue, we've always been an immunology company. And immunology is really an area that has really flourished over the last 10 years.

那或許我會開始。當我來到渤健公司時，我認為我們一直從事免疫學研究，因為基本上很多疾病，例如多發性硬化症，我們都是試圖透過影響免疫系統來進行治療的。正如我所指出的，我們的多發性硬化症藥物甚至無法穿過血腦屏障。所以我認為，我們一直都是一家免疫學公司。免疫學是過去十年蓬勃發展的領域。

And I think DUPIXENT was really one of the first drugs to really demonstrate the disease-modifying capability when you follow those pathways, and of course, they can lead into a wide range of activity. So that's an area we understand. In the short run, I think we're more focused on rare immunology and immunology that is overlaps with areas that we already have some experience in.

我認為，DUPIXENT 是最早真正展現出疾病改善能力的藥物之一，當你沿著這些途徑探索時，當然，它們可以帶來廣泛的活性。所以這是我們了解的領域。短期來看，我認為我們更關注罕見免疫學以及與我們已經有一些經驗的領域重疊的免疫學。

I would argue, for example, with lupus, lupus is an extremely complex disease with a lot of different symptoms and things that affect patients. And I think the experience that Biogen has had in MS will be directly applicable to lupus. And I think we'll be able to develop that market in a way that the existing companies with their products haven't been able to do.

例如，我認為，就狼瘡而言，狼瘡是一種極其複雜的疾病，有許多不同的症狀和因素會影響患者。我認為 Biogen 在多發性硬化症方面累積的經驗可以直接應用於狼瘡治療。我認為我們能夠以現有公司及其產品無法做到的方式開發這個市場。

And I think over time, we can actually build out a portfolio of products that broadly affect the immunology. There's a lot of opportunity here. There's a lot that we still don't understand. And as we look at kind of the first -- the next five years, they're more in this rare immunology. But if I look at a 10-year time frame, then I think we can go into broader indications.

我認為隨著時間的推移，我們實際上可以建立一個廣泛影響免疫學的產品組合。這裡有很多機會。還有很多事情我們不明白。當我們展望未來五年時，他們更關注這種罕見的免疫學領域。但如果從十年時間跨度來看，我認為我們可以得出更廣泛的結論。

And Vanquis is just one example of bringing in an asset that could actually have multiple indications. And I think you'll see us do more of those. And again, these are areas where you really have to have a deep scientific understanding of how these pathways work. They can be -- there are a lot of things that cross over.

Vanquis 只是引入一項可能具有多種適應症的資產的一個例子。我想你們會看到我們做更多這樣的事。再次強調，在這些領域，你必須對這些通路如何運作有深刻的科學理解。它們可以——有很多事物是交叉的。

One of the things that we just see in diseases NRF2, microglia and things like that actually cross over diseases. And that crossover I think is something that we can bring to the immunology part as we go into different indications even with felzartamab, for example, although we're in four kidney indications, we're looking at another three indications that have nothing to do with kidney again, because we understand things like neurofilament and other things, we think that we have perhaps some insight that will allow us to develop medicines that other companies don't.

我們在疾病中看到的一個現像是，NRF2、小膠質細胞等物質實際上在不同的疾病中存在交叉。我認為這種交叉融合可以應用到免疫學領域，即使像 felzartamab 這樣，當我們涉足不同的適應症時，例如，雖然我們目前有四種腎臟適應症，但我們正在研究另外三種與腎臟無關的適應症，因為我們了解神經絲等物質，我們認為我們或許有一些見解，可以讓我們開發出其他公司沒有的藥物。

So for us, it's -- it's a core area. We're not abandoning neuroscience by any means, and we still have a very strong investment in Alzheimer's and ALS. We still have a big one going on in Parkinson's as well. But I do think immunology is a great space for Biogen to be.

所以對我們來說，這是一個核心領域。我們絕對不會放棄神經科學，我們仍然在阿茲海默症和肌萎縮側索硬化症領域投入了大量資源。帕金森氏症領域目前也面臨巨大的挑戰。但我認為免疫學是渤健公司應該涉足的一個絕佳領域。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

You mentioned the focus on expanding your early-stage pipeline via BD, and this is partly driven by the late-stage pipeline here where you have about 10 Phase III trials ongoing. Could you just maybe speak to the confidence in the latter that's allowing you to kind of maybe just work on that earlier basket here.

您提到了透過業務拓展來擴大早期產品線的重點，這部分是由於後期產品線的推進，目前您有大約 10 項 III 期試驗正在進行中。您能否談談您對後者的信心，這種信心讓您能夠專注於之前提到的那個籃框？

I guess there's two parts to the question. The confidence in the late-stage pipeline, certainly, if I look at felzartamab, I think we feel that we've seen some pretty compelling data in the Phase II Obviously, there's always a risk as you go into Phase III. But we've got -- we've seen -- if you just take AMR, I mean we had an 80% resolution of AMR in patients. On IgAN, we saw that actually even two years after the last treatment of a patient that they were still seeing a benefit. So makes us believe that we have a disease-modifying effect in IgAN. So all of those things on felzartamab on BIIB080, obviously, we're doing pioneering work. Nobody has really ever reduced tau to the levels that we expect to be able to do so, and we'll see what the results of those trials -- that trial is.

我想這個問題包含兩個部分。對後期研發管線的信心，當然，以 felzartamab 為例，我認為我們在 II 期臨床試驗中看到了一些非常令人信服的數據。顯然，進入 III 期臨床試驗總是存在風險。但我們已經看到——如果只看 AMR，我的意思是，我們在患者中實現了 80% 的 AMR 緩解。在 IgAN 方面，我們發現，即使在患者接受最後一次治療兩年後，他們仍然能從中受益。這讓我們相信，我們對 IgAN 具有疾病修飾作用。所以，關於 BIIB080 上的 felzartamab 的所有研究，顯然，我們正在進行開創性的工作。從來沒有人真正將 tau 降低到我們預期能夠達到的水平，我們將看看這些試驗的結果——那次試驗的結果。

As I look at lupus, again, we had very strong Phase II results, I think, particularly in CLE where there is no drug yet approved. I think we have a very strong belief Dapirolizumab has already proven itself in one Phase III. And so doing a second Phase III would seem to be -- have a reasonably high probability of success.

再來看狼瘡，我認為我們取得了非常強烈的 II 期臨床試驗結果，尤其是在目前還沒有藥物核准的 CLE 領域。我認為我們非常有信心，達匹羅珠單抗已經在一項 III 期臨床試驗中證明了其有效性。因此，進行第二次 III 期試驗似乎有相當高的成功機率。

And I think, again, even on SLE and lidofiumab, it's an area that the company has been working on for quite a long time. So I think there's never a guarantee in research and development. But I think we have morphed the pipeline from a lot of moon shots, if you like, to something where we've actually had a thoughtful progression and derisking of our pipeline.

而且我認為，即使是 SLE 和利多菲單抗，這也是該公司長期以來一直在研究的領域。所以我認為研發過程中永遠沒有絕對的保證。但我認為，我們已經將產品線從許多不切實際的「登月計畫」轉變為經過深思熟慮、逐步推進並降低風險的產品線。

And if I look at the peak sales potential of that late-stage pipeline in relation to our existing business. (technical difficulty)

如果我看一下後期產品線的銷售潛力高峰與我們現有業務的關係。（技術難題）

Ladies and gentlemen, this is the conference operator. We are experiencing an interruption in today's call. Please stand by. I'm going to place music back on the conference. Do not disconnect your lines.

女士們先生們，這裡是會議接線生。今天的通話出現中斷。請稍候。我打算在會議上重新加入音樂。請勿斷開線路。

Thank you. And you are now reconnected with the audience. You may proceed.

謝謝。現在你又與觀眾建立了連結。您可以繼續。

We kind of disconnect there. Chris, do you want to just respond to the last question, if you don't mind?

我們在這點上有點脫節。克里斯，如果你不介意的話，能不能只回答最後一個問題？

Yes, I'm not sure where we dropped off. It's interesting with all the hundreds of billions of dollars going into data centers and AI. We still have things like telephone calls. Yes, just on the -- so again, high conviction around the late stage, early stage, we are building a lot of commercial capability now in preparing for the launch of that late stage.

是的，我不確定我們在哪裡下車的。數千億美元湧入資料中心和人工智慧領域，這很有趣。我們仍然保留著打電話之類的方式。是的，就目前而言——所以再次強調，我們對後期階段和早期階段都充滿信心，我們現在正在建立大量的商業能力，為後期階段的啟動做準備。

Building up an awful lot of capability and understanding of immunology and now it makes sense to actually continue that and build upon that in the early stage. A lot of companies get so focused on the launches and the late-stage pipeline that research can sometimes be neglected. But this is now really the time to be investing in the next generation of products. And I would argue there's never been a better time to be in immunology. And I think Biogen is ideally suited to it.

我們已經累積了大量的免疫學能力和理解，現在是時候繼續並在此基礎上，在早期階段繼續發展了。許多公司過於專注於產品上市和後期研發，以至於有時會忽略研發工作。但現在正是投資下一代產品的最佳時機。而我認為，現在是投身免疫學領域的最佳時機。我認為 Biogen 非常適合這項工作。

Brian Abrahams, RBC Capital Markets.

Brian Abrahams，加拿大皇家銀行資本市場。

Maybe a question for Alisha. Can you give us a sense on the early experience with LEQEMBI subcu maintenance uptake and access with regards to non formulary exceptions what the potential time lines might look like to get on formularies, both for maintenance and induction? And maybe whether we should be thinking about net price here, ultimately landing at parity between the IV and the subcu forms?

或許可以問問艾麗莎。您能否介紹一下 LEQEMBI 皮下維持治療的早期推廣和取得情況，特別是對於非處方藥例外情況，以及納入處方集（包括維持治療和導入治療）的潛在時間線？或許我們應該考慮淨價，最終使 IV 和子帳戶形式的價格持平？

All right. Thank you for the questions. I think so far, the feedback has been very positive from not only payers but HCPs and patients. We also anticipate that subcu maintenance is going to enable patients to also stay on therapy longer. So we see it as a big upside. It will take some time for providers and patients to just with new outpatient treatment modality even in a maintenance capacity.

好的。謝謝大家的提問。我認為到目前為止，不僅支付方，而且醫護人員和患者的回饋都非常積極。我們也預期皮下維持治療將使患者能夠接受更長時間的治療。所以我們認為這是一個很大的優勢。即使是維持治療，醫護人員和病患也需要一段時間才能適應新的門診治療方式。

But we do see this as a great bridge as we move into the potential of subcu initiation. So we do expect a gradual uptake, but over time, it will become a meaningful driver for long-term therapy and for our treatment outcomes. Now and into next year, what the teams are doing is first are educating sites on what you referenced, which is this non-formulary redemption process.

但我們認為這是通往皮下植入潛力的重要橋樑。因此我們預期會逐漸普及，但隨著時間的推移，它將成為長期治療和治療效果的重要驅動因素。現在以及明年，各團隊首先要做的就是向網站普及你提到的內容，也就是這個非處方兌換流程。

However, payers have told us that this should not pose challenges to HCPs who are interested in transitioning their patients from IV and we are already aware of the first patients successfully navigating this process with their physicians, and we do know that we have several patients that are already on subcu.

然而，支付方告訴我們，這不應該給有興趣將患者從靜脈輸液過渡到皮下輸液的醫療保健專業人員帶來挑戰，我們已經知道第一批患者在醫生的幫助下成功完成了這一過程，而且我們也知道我們已經有幾位患者正在接受皮下輸液。

We also have a companion that has rolled out to the entire market that's also helped patients with how to do the auto injection, making sure they get their shipments and also making sure that physicians feel comfortable. Also through the non-formulary exemption process, if you look at analogs in the market outside of Alzheimer's disease, great rates are typically quite high.

我們也推出了一款配套產品，已推廣至整個市場，該產品也幫助患者了解如何進行自動注射，確保他們收到藥品，並確保醫生感到安心。此外，透過非處方藥豁免程序，如果您查看阿茲海默症以外的市場上的類似藥物，就會發現其療效通常非常顯著。

So again, we don't think that will pose a challenge. And then second is working through this Medicare Part D formulary for in the cycle for the goal of gaining access for patients across the nation. So we are now going through that process for Medicare, and we believe that we will have access, full access by 2027. In the meantime, though, they do go through the non-formulary exemption process. But at the end of the day, we are hearing that iClick is really just an amazing option for patients and physicians.

所以，我們認為這不會構成挑戰。其次，要著手研究 Medicare Part D 的藥品目錄，以便在周期內實現讓全國各地的患者都能獲得藥品的目標。所以我們現在正在推進醫療保險的進程，我們相信到 2027 年我們將獲得完全的醫療保險。但同時，他們確實需要經過非處方藥豁免程序。但歸根結底，我們聽到的回饋是，iClick 對於患者和醫生來說確實是一個非常棒的選擇。

In fact, just the other day, I was speaking to a physician who had done his 10,000 infusion of LEQEMBI. And he said some of his patients are very excited they can go on vacation. They can take this with them, and it's now giving them freedom to be able to travel even more than what they do today. So far, so good. Moving into 2026, and we believe the initiation is going to even be a great accelerator for us as well.

事實上，就在前幾天，我和一位醫生聊過，他已經完成了 10,000 次 LEQEMBI 輸注。他說，他的一些病人非常興奮，因為他們可以去度假了。他們可以帶著它到處走，這讓他們現在能夠比現在更多地去旅行，從而擁有更大的旅行自由。到目前為止，一切都很好。展望 2026 年，我們相信這項計畫甚至會成為我們發展的一個強大加速器。

Paul Mattis, Stifel.

Paul Mattis，Stifel。

There's been a lot of increasing interest in the prevention studies being run by Lilly and U and ESI. And I guess I wanted to just ask a broader question. How should we think about the commercial implications if these studies are positive? Obviously, these could change the narrative significantly on the utility of Abeta drugs. But what our team is struggling with is it's still a real challenge to actually treat the diagnosed population.

人們對禮來、U 和 ESI 進行的預防研究越來越感興趣。我想問的是一個更廣泛的問題。如果這些研究結果為陽性，我們該如何看待其商業影響？顯然，這些可能會大大改變人們對Aβ藥物效用的看法。但我們的團隊面臨的難題是，如何真正治療已確診的患者群體仍然是一個真正的挑戰。

There's all these capacity issues. MRIs. It's been a very, very complicated sort of supply chain. And so -- it feels to me like actually diagnosing patients and mobilizing providers to treat people who are asymptomatic might create even more significant capacity issues and difficulties with, again, the whole chain of use with these drugs. So what would you say to that? And how can you guys sort of prepare for a successful outcome here to actually generate a significant ROI.

存在各種各樣的產能問題。核磁共振成像。這條供應鏈非常非常複雜。因此——在我看來，對無症狀患者進行診斷並動員醫護人員治療，可能會造成更大的容量問題，並再次給這些藥物的整個使用鏈帶來困難。你對此有何看法？那麼，你們該如何為成功做好準備，從而真正獲得可觀的投資報酬率呢？

You want to take that.

你想拿走它。

Thanks for the question. I'll go ahead and take that one. We've been thinking about this quite a bit, obviously, with top of mind as the potential of a successful trial reading out, whether it is going to be release trial or it will be (inaudible) trial.

謝謝你的提問。我來接下這個任務。顯然，我們一直在認真考慮這個問題，首要考慮的是試讀成功的可能性，無論是正式發布還是正式試讀。

And some of the things that we're looking at is especially in the PCP area, how they improve the quality of their referrals into physicians. Now as I said, blood-based biomarkers are growing at a rapid pace. Also just recently, Roche had a BBM that was approved called Alexis. And this is really only a rule out BBM and is approved for a primary care setting, which basically helps them with this sort of asymptomatic or very early stage. Alzheimer's disease.

我們正在研究的一些問題，尤其是在初級保健醫生（PCP）領域，是如何提高他們向醫生轉診的品質。正如我剛才所說，基於血液的生物標記正在快速發展。就在不久前，羅氏公司有一款名為 Alexis 的生物膜生物製劑獲得了批准。這實際上只是排除 BBM 的一種方法，並且已獲准在初級保健機構中使用，這基本上可以幫助他們處理這種無症狀或非常早期的階段。阿茲海默症。

So we believe through some of the efforts of the field on educating, which, by the way, we're not the only ones. There are several organizations that are supporting these efforts to make sure that physicians understand that a lot of these BBMs meet the criteria for confirmation. And what we're seeing is that during a pilot that we're running now, which we'll read out after the next quarter is can we actually improve the prescribing or the diagnosing and also then the referral and the quality of that referral.

所以我們相信，透過該領域在教育方面的一些努力，順便說一句，我們並不是唯一這樣做的人。有幾個組織正在支持這些努力，以確保醫生們明白，許多這類 BBM 符合確診標準。我們看到，在我們正在進行的試點計畫中（我們將在下一季結束後公佈結果），我們能否真正改善處方或診斷，以及轉診和轉診品質。

I will say, though, that we are seeing already in PET CSF that the positivity rates of those tests have increased dramatically as well at the beginning of this journey, we were sitting at 50-50 positive versus negative and we are now north and upwards of that number and positivity. We believe that's through the improvement of the triaging with the blood-based biomarkers. So I think that's one part of it.

不過，我要說的是，我們已經看到 PET CSF 檢測的陽性率也大幅上升。在這段旅程的開始，陽性與陰性的比例是 50:50，而現在陽性率已經超過了這個數字。我們認為這是透過改進基於血液生物標記的分診來實現的。所以我覺得這是其中一部分原因。

The second part of it is, of course, some of these patients then won't land in Medicare depending on their age. And so it's how do we also socialize and work with the commercial plans because they are the ones that would need to cover the product at that point. And so clearly, some of those conversations have already happened because we do have some younger population patients that want to go on product -- and so I do think we are thinking through that. And by the time these trials read out, I do think that capacity will be also much better.

當然，第二部分是，其中一些患者由於年齡原因可能無法享受聯邦醫療保險。所以，我們還要如何與商業計劃溝通合作呢？因為到那時，是他們需要承擔產品的費用。顯然，其中一些對話已經發生，因為我們確實有一些年輕患者群體想要使用該產品——所以我認為我們正在認真考慮這個問題。等到這些試驗結果出來的時候，我認為產能也會好得多。

And I think we can also say to complement what Alisha just said, the subcutaneous form when that gets effect gets approved as we expect for initiation for maintenance. If the blood-based diagnostics start to replace the PET scan and the lumbar puncture, you're dramatically reducing the workload at the neurology. And as we've talked about in past meetings.

而且我認為，為了補充 Alisha 剛才所說的，皮下注射劑一旦生效，就會像我們預期的那樣獲得批准，用於啟動和維持治療。如果血液診斷開始取代 PET 掃描和腰椎穿刺，就能大幅減輕神經科的工作量。正如我們在之前的會議中討論過的那樣。

A lot of what we've been doing is trying to make the care pathway simpler for physicians with the idea of being able to increase throughput. And as Alisha rightly pointed out, I mean, Today, about half of the patients who are able to get at a point where their neurologists are not actually eligible. And again, as we increase that yield really from the referrals, as Alisha pointed out, that again will significantly increase the capacity. And we have to say that we still have quite a few neurologists that have not yet actually initiated therapy on Alzheimer's. So this -- I think we'll still -- as this comes along, I think we'll find that the capacity will flex.

我們所做的許多工作都是為了簡化醫師的診療流程，進而提高診療效率。正如艾莉莎正確指出的那樣，我的意思是，如今，大約有一半的患者能夠達到這樣的程度，但他們的神經科醫生實際上並不符合資格。正如艾莉莎所指出的那樣，隨著我們真正提高推薦帶來的收益，產能也將顯著提高。我們必須指出，目前仍有不少神經科醫生尚未真正開始對阿茲海默症患者進行治療。所以，我認為隨著事情的發展，我們會發現產能會靈活調整。

Marc Goodman, Leerink Partners.

馬克古德曼，Leerink Partners。

My question is about Sky Claris. Can you just give us a little more color on what's happening behind the scenes? I mean, you mentioned the $6 million impact in US sales, and you talked about OUS reimbursement issues a little bit. what's going on with volume growth maybe in the US and then just overseas? Or are we seeing patient growth? Are we seeing good persistence like are there discontinuations? Just give us a sense of just what's happening with Sky Claris a little bit more.

我的問題是關於Sky Claris的。能再詳細介紹一下幕後發生的事嗎？我的意思是，你提到了美國銷售額受到的600萬美元影響，也稍微談到了海外報銷問題。那麼，美國以及海外的銷售成長情況如何呢？還是我們看到的是患者數量的成長？我們是否看到了良好的持續性，例如是否有中斷？請再詳細介紹一下 Sky Claris 目前的狀況。

Thank you. I'll go ahead and take that question. I think first four, I'll start with ex US Building on the successful launch in the US, we continue unlocking new geographies for Sky Claris, which is now available, as we said earlier, in 34 countries. And we are pleased to see the steady and continuous growth once the access is granted overseas.

謝謝。我來回答這個問題。我認為首先是四個方面，我將從美國開始。基於在美國的成功推出，我們繼續為 Sky Claris 解鎖新的地區，正如我們之前所說，它現在已在 34 個國家/地區可用。我們很高興看到，一旦獲得海外准入資格，業務就能穩定持續成長。

And with that is a country-by-country basis, and they do continue to add patients on a weekly basis, which we see updates about. When you look at the US, the US is in a different situation because we did launch earlier. And with that, we have basically had very high penetration in our centers of excellence, and we believe 90% of our remaining opportunity sits in the community. And so we do have patient growth, and we do have volume growth. When it comes to discontinuations, when we first launched, we did notice that in the beginning, our discons, though in line with Moxy, we're happening quite early on, and we put a lot of tactics into place over this last year to address that with not only the field force, but the medical team.

而且這是按國家/地區劃分的，他們每週都會繼續增加患者，我們也會看到相關的更新資訊。看看美國，美國的情況就不同了，因為我們啟動得更早。因此，我們在卓越中心的滲透率已經非常高，我們相信剩餘機會的 90% 都蘊藏在社區中。因此，我們的患者數量確實在成長，我們的業務量也在成長。說到停產，我們剛推出產品時就注意到，雖然與 Moxy 的情況類似，但我們的停產發生得相當早，因此在過去一年裡，我們採取了很多策略來解決這個問題，不僅包括銷售團隊，還包括醫療團隊。

And I will say, fast forward to today, our discount rates have actually declined. So we've improved our discontinuation with education with physicians about some of the side effects they see and also what patients can expect. I think the second part of this, which I think will probably impact the entire world with this launch is how patients after they've been on it for a year or 1.5 years, because it slows the progression, it's very hard to be able to see like what does slowing progression look like.

而且，時至今日，我們的折現率其實已經下降了。因此，我們透過對醫生進行教育，讓他們了解一些他們看到的副作用以及患者可以預期的情況，從而改善了停藥流程。我認為第二部分，也是我認為這次上市可能會影響全世界的部分，是患者在使用一年或一年半之後的情況，因為它減緩了病情進展，所以很難看出病情進展減緩究竟是什麼樣子。

And we have had a couple of instances where patients have discounted after about a year's time period, they've declined actually quite quickly, and they've now come back on to products. So we do know that at that time point, we will put more tactics into place on educating the actual patients and activating the patients.

我們遇到過一些情況，患者在大約一年後開始減少用藥，實際上用藥速度很快，但現在他們又重新開始使用產品了。所以我們知道，到那時，我們將採取更多策略來教育患者並調動患者的動機。

Let's go to the next question, please.

我們進入下一個問題吧。

Andrew Tsai, Jefferies.

Andrew Tsai，傑富瑞集團。

So going back to Alzheimer's, you guys have a Phase II tau data set coming up mid-2026. So I'm curious what you would want to see on CDR-SB and the degree of talent reduction as well? And if that study is positive, what would be your guys' base case and upside case expectation on the regulatory pathway?

回到阿茲海默症的話題，你們將在 2026 年年中獲得第二階段 tau 資料集。所以我很好奇你希望在CDR-SB看到什麼，以及人才流失的程度？如果這項研究結果是正面的，你們對監管路徑的基本預期和樂觀預期分別是什麼？

Sure. So I think overall, we believe that (inaudible) is really important pathological target and accumulation of tau is relevant and central to Alzheimer's disease. With BIIB080, the approach we've taken is really to address whether knocking down to, all six isoforms of tau can result in target engagement.

當然。所以總的來說，我們認為（聽不清楚）是一個非常重要的病理靶點，tau 蛋白的累積與阿茲海默症密切相關且至關重要。我們使用 BIIB080 的方法，實際上是在研究敲除 tau 的所有六種亞型是否會導致標靶結合。

So we would need to see impact on biomarkers, fluid biomarkers, imaging biomarkers and then see at least a trend on the clinical benefit. That would be important for us to kind of think about the hypothesis. We know that early-stage research in AD is always highly uncertain. But I think if this hypothesis is proven, there's a huge opportunity. Now I think the other question you had was how would we think about it in the portfolio perspective.

因此，我們需要觀察對生物標記、體液生物標記、影像生物標記的影響，然後至少要觀察臨床獲益的趨勢。這對我們來說很重要，因為我們需要仔細思考這個假設。我們知道，阿茲海默症早期研究總是充滿高度不確定性。但我認為，如果這個假設得到證實，那將是一個絕佳的機會。現在，我想你還有另一個問題，那就是從投資組合的角度來看，我們應該如何看待這個問題。

I think once we have that, it would be a stepwise approach to thinking of if it is positive, is there value to combination, parallel, sequential dosing and these are areas that we're thinking about really deeply as we think about what would be the optimal approach and outcome for patients with early Alzheimer's.

我認為一旦我們有了這一點，就可以逐步考慮它是否有效，聯合用藥、平行用藥、序貫用藥是否有價值，這些都是我們正在深入思考的領域，因為我們正在思考對於早期阿茲海默症患者來說，最佳方法和結果是什麼。

Let's go to the next question, please.

我們進入下一個問題吧。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

Maybe just a follow-up for me on Tao. I know J&J is progressing an anti-tau antibody in Phase II and could have some data early next year. you guys obviously explored this approach as well. I think there are some differences maybe in terms of binding here. But when we see that J&J data, assuming it comes before BIIB080, how should we think about read through to your ASO program.

或許我只是想就陶（Tao）這個問題做個後續探討。我知道強生公司正在推進一種抗tau蛋白抗體的第二期臨床試驗，可能明年年初就能獲得一些數據。你們顯然也探索過這種方法。我認為在粘合方面可能存在一些差異。但是，當我們看到強生公司的數據時，假設它早於 BIIB080，我們應該如何考慮將其解釋為你們的 ASO 計劃的一部分？

I think overall, based on what I understand from the J&J program, this is positinimab. And it's a tau monoclonal antibody it targets the mid-domain of tau. So it is different. And in our experience, we've had an experience and the field has had an experience of targeting tau with monoclonal antibodies thus far, that has not been promising.

我認為，根據我對強生公司專案的了解，總體而言，這就是positinimab。它是一種 tau 單株抗體，靶向 tau 蛋白的中間結構域。所以情況有所不同。根據我們的經驗，以及該領域迄今為止使用單株抗體靶向 tau 的經驗，結果並不理想。

And we believe that the main reason here is the extracellular tow that it targets. And actually, that is the hypothesis. SPAs is testing. So we'll wait to see they are in Phase II. And I think what we saw from the Phase I data was an impact in some of the fluid biomarkers However, we didn't actually see any data on tau PET, which we believe is very important. So we'll look for that data.

我們認為主要原因是它所針對的細胞外束。實際上，這就是假設。SPAs正在進行測試。所以我們會拭目以待，看看他們是否進入第二階段。我認為我們從 I 期數據中看到的是一些體液生物標記受到了影響。然而，我們實際上並沒有看到任何關於 tau PET 的數據，我們認為這非常重要。所以我們會去找找這些數據。

And in terms of read-through I think, as I said, it's early days for research in Alzheimer's disease with an anti-tau agent. So we'll have to see what we see and then really try to analyze it but I think if it works, it could be helpful, right, because it would then address the point that is knocking down to actually has an impact. So I think it would be overall positive, but we wait to see the data first.

至於閱讀理解方面，我認為，正如我所說，使用抗 tau 藥物治療阿茲海默症的研究還處於早期階段。所以我們必須看看我們能看到什麼，然後認真分析一下，但我認為如果它有效，那可能會有所幫助，對吧，因為它就能解決擊倒球員的問題，從而真正產生影響。所以我認為整體上會是正面的，但我們還是先等等數據吧。

Let's go to the next one, please, Cynthia.

辛西婭，我們開始下一個。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

I have ZURZUVAE question. So just wanted to get your thoughts on the fit of the product in the commercial portfolio, given that it's primarily a women's health product that doesn't really synergize with your other business units. I guess, how are you thinking about keeping the asset now that more well-resourced well-capitalized partner now controls the other 50%?

我有一個 ZURZUVAE 問題。所以我想聽聽您對該產品在商業組合中的契合度有何看法，因為它主要是一款女性健康產品，與貴公司的其他業務部門並沒有真正的協同效應。我想問，既然資金雄厚、資源豐富的合作夥伴現在控制了另外 50% 的股份，您打算如何保住這項資產？

Well, I'm not sure how well capitalized I would say. I think we are -- we still feel like first, we are very happy with the partnership with Supernas. I mean that is going extremely well. And they have taken a different approach than SAGE. But I do think that this is still a product where Biogen actually can play a significant role. There is a huge unmet need. You're having to shape a market.

嗯，我不太確定它的資金狀況如何。我認為我們——我們仍然覺得，首先，我們對與 Supernas 的合作關係感到非常滿意。我的意思是，進展非常順利。他們採取的方法與SAGE不同。但我認為，在這個產品領域，百健仍然可以發揮重要作用。存在巨大的未滿足需求。你必須塑造一個市場。

And that is an area where commercially Biogen is very strong. from a resource point of view, I'm not so sure that even for Supernus is this is an easy fit because the prescriber base for Supernus typically is a psychiatrist but here, the main prescriber is actually the OB/GYN. And so the resource level, I think, compared to the actual sales and profit of the product, still mean that this is an opportunity.

而這正是百健公司在商業上非常強大的領域。從資源角度來看，我不太確定即使對於Supernus來說，這是否是一個容易的契合點，因為Supernus的處方醫生通常是精神科醫生，而在這裡，主要的處方醫生實際上是婦產科醫生。因此，我認為，就資源水平而言，與產品的實際銷售和利潤相比，這仍然意味著這是一個機會。

I'm not sure we are keen to get into other neuropsychiatry areas. But I think in terms of being able to create a market, at least and her team are doing a terrific job. It was a tricky one because, again, this is a one-and-done treatment. And so you really have to build prescribers who are prescribing multiple times. But the opportunity is significant.

我不確定我們是否熱衷於涉足其他神經精神病學領域。但我認為，至少在創造市場方面，她的團隊做得非常好。這很棘手，因為，這又是一次性治療。所以，你真的需要培養能夠多次開處方的醫生。但這是一個意義重大的機會。

There's only about 80,000 women treated today and about 500,000 mothers, and this is just the US alone, I believe this suffer from postpartum depression. So I think this fits very much with the ethos of Biogen. And I don't know, Alisha, whether you want to add anything there?

目前僅約有 8 萬名女性接受治療，約有 50 萬名母親患有產後憂鬱症，而這僅僅是美國的情況。所以我認為這非常符合百健的理念。艾莉莎，我不知道你是否想補充什麼？

Yes. Just to add to what Chris said. I mean, first of all, we have really gotten off to a great start with Supernus, and they've done a really nice job of trying to minimize the business impact anytime we have a handover. So we really are off to a very good start with them.

是的。我補充一下克里斯剛才說的話。首先，我們與 Supernus 的合作開局非常順利，他們在每次交接時都盡力將業務影響降到最低，做得非常好。所以，我們和他們的合作開局非常順利。

On the surface, it looks like there are synergies when it comes to the rest of the portfolio, but that's only when you look at really the field force. If you look behind the scenes and you look at really our infrastructure of Biogen, which we're in a very fortunate situation. And you look at things like our bio group, which is really our commercial operations group, we have a lot of synergy when it comes to data and analytics insights generation.

表面上看，它與其他產品組合似乎存在協同效應，但這只有在你真正審視銷售團隊時才會發現。如果你深入了解一下，看看我們 Biogen 的基礎設施，你會發現我們處境非常幸運。再看看我們的生物技術團隊，它實際上是我們的商業營運團隊，我們在數據和分析洞察生成方面有很多協同效應。

And especially, we have a very strong omnichannel presence. And so what's been great about even putting ZURZUVAE into our portfolio is that we've been able to utilize a lot of the back office support to support this launch. And we believe that's also part of the reason why the launch has been successful is because of all of the experience that we've had with our other products.

尤其值得一提的是，我們擁有非常強大的全通路佈局。因此，將 ZURZUVAE 納入我們的投資組合的好處在於，我們能夠利用大量的後台支援來支援此次發布。我們認為，此次產品發表成功的部分原因在於我們先前在其他產品方面所累積的所有經驗。

And also with our AI generation, we're doing some really interesting things for the ZURZUVAE launch as well. So stay tuned also on some more direct-to-consumer that we're planning for next year, which I think is really going to be a great accelerator for ZURZUVAE.

此外，憑藉我們的人工智慧技術，我們也在為 ZURZUVAE 的發布做一些非常有趣的事情。所以，敬請期待我們明年計劃推出的更多直接面向消費者的產品和服務，我認為這真的會成為 ZURZUVAE 的一大加速器。

Maybe I can just add that we also have approvals in the new and UK, and it is a very important moment for mothers with PPD because it wasn't really recognized as an entity, and this speaks to the quality of the data and the efforts and the high unmet way.

我還可以補充一點，我們在新西蘭和英國也獲得了批准，這對患有產後憂鬱症的母親來說是一個非常重要的時刻，因為產後憂鬱症以前並沒有被真正認可為一種疾病，這體現了數據的品質、我們所做的努力以及我們尚未滿足的巨大需求。

Let's go to our last question, please.

我們進入最後一個問題。

Jeff Meacham, Citi.

傑夫‧米查姆，花旗銀行。

It's Ross on for Jeff. I guess our question is, how was -- how is the company thinking about capital allocation, especially considering balancing BD and new launches, especially if there seems to be a heightened focus on developing an earlier-stage pipeline?

羅斯替補傑夫上場。我想我們的問題是，公司過去是如何考慮資本配置的，特別是考慮到平衡業務拓展和新產品發布，尤其是在似乎更加註重開發早期產品線的情況下？

Yes. Thanks, Jeff. I mean, first, everything we're doing, as I said earlier, is to invest in long-term sustainable growth. We have been able to, I think, do a great job through previous judgment of building a very strong late-stage development pipeline. I mean a lot of companies when you're putting a lot of things into Phase III development start having to increase the R&D spend and yet we are still actually spending less than what we did three years ago. So I think we've demonstrated capital efficiency on that.

是的。謝謝你，傑夫。我的意思是，首先，正如我之前所說，我們所做的一切都是為了投資長期可持續成長。我認為，憑藉以往的判斷，我們已經成功地建立了一個非常強大的後期研發管線。我的意思是，許多公司在投入大量資源進行三期臨床試驗時，不得不增加研發支出，然而我們目前的支出實際上仍然比三年前要少。所以我認為我們已經證明了我們在這方面的資本效率。

We're being very thoughtful but also the indications. So we're not going into indications where we have to go up against typically an AbbVie or a Sanofi or people like that. So the actual commercial investment is relatively modest compared to the opportunity. And that's, again, a space where Biogen plays well. We are recruiting people to bring in new capabilities in nephrology and in transplant and in lupus but that's actually a relatively small number of people.

我們考慮得非常周全，同時也參考了相關跡象。所以我們不會進入需要與艾伯維、賽諾菲或類似的公司競爭的領域。因此，與機會相比，實際的商業投資相對較少。而這，正是 Biogen 擅長的領域。我們正在招募人員，以提升腎臟病學、移植和狼瘡方面的專業能力，但實際上人數相對較少。

And I think one of the best times to bring in assets is actually pre-IND you can do that on a cost-effective basis. You can take advantage of the fact that a lot of companies have venture capital backed financing, that is designed to take that risk, and you can actually build a portfolio easier of early-stage assets, either by collaboration or licensing. And then you bring them in at the right point where Biogen can actually start to use, it's more commercially oriented skills and development skills to shape those products.

我認為引入資產的最佳時機之一實際上是在IND之前，這樣可以以更具成本效益的方式進行。您可以利用許多公司都有風險投資支持的融資這一事實，這種融資旨在承擔風險，並且您可以透過合作或許可更容易建立早期資產組合。然後，在合適的時機將他們引入，讓 Biogen 能夠真正開始利用他們更具商業導向的技能和開發技能來塑造這些產品。

So I think from a capital allocation point of view, I think we can manage all of this. And I think we still have room, and we're not abandoning looking at later-stage assets, but the later this stage, obviously, the more expensive and you have to be extremely disciplined on ensuring that whatever you buy is going to generate a return on investment. So I think we are in a good spot today. And I think we've got the capital we need to do the business. But of course, we're continually monitoring that and making sure that everything we do is driving shareholder value.

所以我覺得從資本配置的角度來看，我們能夠應付這一切。我認為我們還有空間，我們不會放棄專注於後期資產，但顯然，越到後期，成本就越高，你必須非常自律，確保你購買的任何東西都能產生投資回報。所以我覺得我們今天處境不錯。我認為我們有足夠的資金來開展這項業務。當然，我們會持續關注這一點，並確保我們所做的一切都能提升股東價值。

Thanks, Chris. That's it for today. I know it's a very busy morning for everybody. When you've got more questions, the IR team is here to answer those for you. Thank you.

謝謝你，克里斯。今天就到這裡。我知道今天早上對每個人來說都很忙。如果您還有其他疑問，投資人關係團隊隨時為您解答。謝謝。

This concludes today's call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。