Biogen Inc (BIIB) 2024 Q1 法說會逐字稿

Good morning. My name is Jennifer, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Biogen First Quarter 2024 Earnings Call and Business Update. (Operator Instructions) Today's conference is being recorded. Thank you.

早安.我叫詹妮弗，今天我將擔任你們的會議操作員。此時，我謹歡迎大家參加百健 (Biogen) 2024 年第一季財報電話會議和業務更新。 （操作員指示）今天的會議正在錄音。謝謝。

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

現在我想將會議交給投資者關係主管查克·特里亞諾 (Chuck Triano) 先生。特里亞諾先生，您可以開始會議了。

Thanks, Jennifer. Good morning, good afternoon, good evening, everyone, and welcome to Biogen's First Quarter 2024 Earnings Call.

謝謝，珍妮佛。大家早安、下午好、晚上好，歡迎參加百健 (Biogen) 2024 年第一季財報電話會議。

Before we begin, I'll remind you that the earnings release and related financial tables, including our GAAP financial measures, with the reconciliation to the GAAP and non-GAAP financial measures that we will discuss today, are in the Investors section of biogen.com. Our GAAP financials are provided in tables 1 and 2, and Table 4 includes a reconciliation of our GAAP to non-GAAP financial results. We believe that non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We have also posted the slides on our website that will be used during this call.

在我們開始之前，我要提醒您的是，收益發布和相關財務表格，包括我們的GAAP 財務指標，以及我們今天將討論的GAAP 和非GAAP 財務指標的調節表，位於百健（biogen）的投資者部分。表 1 和表 2 提供了我們的 GAAP 財務數據，表 4 包括我們的 GAAP 與非 GAAP 財務表現的調整表。我們相信，非公認會計準則財務表現更能代表了我們業務的持續經濟狀況，並反映了我們內部管理業務的方式。我們也在我們的網站上發布了本次電話會議期間將使用的幻燈片。

I'd point out that we will be making forward-looking statements, which are based on our expectations. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail.

我想指出的是，我們將根據我們的預期做出前瞻性聲明。這些陳述存在一定的風險和不確定性，我們的實際結果可能有重大差異。我鼓勵您查閱我們向 SEC 提交的文件中討論的風險因素，以了解更多詳細資訊。

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; our Head and President of North America, Alisha Alaimo; our CFO, Mike McDonnell; and Dr. Priya Singhal, Head of Development, is with us and will be available for the Q&A session. Chris, Alisha and Mike will each make some opening comments, and then we'll move to the Q&A session. And to allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question.

我們的總裁兼執行長 Chris Viehbacher 也參加了今天的電話會議。我們的北美地區負責人兼總裁 Alisha Alaimo；我們的財務長麥克麥克唐納；開發主管 Priya Singhal 博士與我們在一起，並將參加問答環節。克里斯、艾莉莎和麥克將分別發表一些開場評論，然後我們將進入問答環節。為了讓我們能夠回答盡可能多的問題，我們懇請您只回答一個問題。

With that out of the way, I'll now turn the call over to Chris.

解決這個問題後，我現在將把電話轉給克里斯。

Thank you, Chuck. Good morning, everybody. Well, it is certainly great to be able to announce earnings per share growth in our first quarter. This is the first time in several years that the underlying business performance of Biogen has allowed us to actually demonstrate the earnings per share growth. And that's a major achievement. We've clearly still got a lot of work to do, but I think it feels like we're turning the corner in the company.

謝謝你，查克。大家早安。嗯，能夠宣布第一季每股收益的成長確實很棒。這是多年來百健（Biogen）的基本業務業績首次讓我們能夠實際展示每股收益的成長。這是一項重大成就。顯然我們還有很多工作要做，但我認為我們公司正在扭轉局面。

And with that, I'd like to actually take the opportunity to thank my Biogen colleagues. We have instituted an awful lot of change within the company. And I'd like to thank them for their commitment, passion and patience throughout this process.

在此，我想藉此機會感謝我的百健（Biogen）同事。我們在公司內部進行了巨大的變革。我要感謝他們在整個過程中的承諾、熱情和耐心。

But I think you're seeing some of that change that has occurred now in the numbers. We have tried to bring a lot more focus and discipline to really putting our resources behind those things that do good and drive value.

但我認為你已經看到了數字中現在發生的一些變化。我們試圖更加關注和遵守紀律，真正將我們的資源投入那些行善和推動價值的事情。

And one of the things that you may not see is that there is an awful lot of reinvestment going on. One of my early bosses in my career once told me, you can't save your way to prosperity in this business. And that is absolutely true. And that's not really what we set out to do.

您可能看不到的一件事是正在進行大量的再投資。我職業生涯早期的一位老闆曾經告訴我，在這個行業裡，你無法透過儲蓄來實現繁榮。這是絕對正確的。這並不是我們真正打算做的。

The Fit for Growth project, which is, as you can see from the numbers, on track to achieve its $1 billion in gross savings and $800 million in net cost savings, and by the way, $800 million of increased cash flow as well, by the end of 2025.

正如您從數字中看到的，Fit for Growth 項目預計將實現 10 億美元的總節省和 8 億美元的淨成本節省，順便說一句，還將增加 8 億美元的現金流。

But what we really tried to do was redesign the organization. We have been so focused as a business for decades on our multiple sclerosis franchise, and here we are launching 4 first-in-class new medicines, and we really needed to make sure we're supporting those launches. And in fact, despite the cost reductions and margin improvements that Mike is going to go into in more detail, but behind that, there are hundreds of millions of dollars being invested in new launches.

但我們真正想做的是重新設計組織。作為一家企業，我們幾十年來一直專注於我們的多發性硬化症特許經營權，現在我們正在推出 4 種一流的新藥，我們確實需要確保我們支持這些上市。事實上，儘管麥克將更詳細地討論成本降低和利潤提高，但在這背後，有數億美元投資於新產品的推出。

And while our overall expense in research and development has decreased, this focus has actually enabled us to increase the investment in those assets where we have the most conviction. So this is much more than a cost savings exercise. This has been a redesign, and a change in our culture to a degree.

雖然我們在研發方面的整體費用有所下降，但這一重點實際上使我們能夠增加對我們最有信心的資產的投資。因此，這不僅僅是節省成本的做法。這是一次重新設計，在某種程度上改變了我們的文化。

So let's look at some of these new launches. And obviously, the one that everybody is most interested in is LEQEMBI, and if we can move to that slide.

讓我們來看看其中一些新產品。顯然，每個人最感興趣的是 LEQEMBI，如果我們可以轉到那張投影片。

You can look at this in a number of different layers. Obviously, first, we're seeing really good quarter-on-quarter trends. As you've seen, the number of patients on drug has increased 2.5-fold compared to where we finished the fourth quarter. Our in-market revenue almost tripled in Q1 versus Q4 of last year. And that's obviously important.

您可以從多個不同的層面來看待這一點。顯然，首先，我們看到了非常好的季度環比趨勢。正如您所看到的，與第四季末相比，接受藥物治療的患者人數增加了 2.5 倍。與去年第四季相比，我們第一季的市場收入幾乎增加了兩倍。這顯然很重要。

But the thing that really is important to me, as I look at this, is not so much just that. I've been in this business for 3.5 decades, I've lost count of how many launches I've seen. But this is an extraordinarily difficult launch, really because the amount of change that physicians are facing with this is really profound. And as I go around to hospitals and talk to doctors and talk to those who are seeing other doctors, it really becomes evident that there are an awful lot of challenges to getting that -- even that first patient on treatment.

但對我來說真正重要的事情並非如此。我從事這個行業已經 3.5 年了，我已經記不清見過多少次產品發布了。但這是一次極其困難的啟動，因為醫生面臨的改變確實是深遠的。當我去醫院、與醫生交談以及與那些正在看其他醫生的人交談時，很明顯，要實現這一目標存在著巨大的挑戰——即使是第一個接受治療的患者也是如此。

We are at one hospital, it was going to take -- it took them 3 months to get approval just to hire a nurse to help navigate the system. And another major medical center, they were having to develop a 5-year business plan just to be able to access the infusion beds. And when you look at some of the uncertainty around PET scan reimbursement, and although CMS had clarified that, a lot of them actually had pulled it through, there was still a lot of difficulty getting that clarity all the way through the channel.

我們在一家醫院，他們需要 3 個月的時間才能獲得批准，只是聘請一名護士來幫助操作系統。而另一家大型醫療中心，他們必須制定五年商業計劃才能使用輸液床。當你看到PET 掃描報銷方面的一些不確定性時，儘管CMS 已經澄清了這一點，但他們中的許多人實際上已經渡過難關，但在整個管道中保持這種清晰度仍然有很多困難。

And what I'm really encouraged by when I look at these numbers is, when -- although there are a lot of challenges, it's a lot of time investment for physicians, and I think a lot of those physicians, to their credit, are investing that time and not necessarily getting reimbursed for that. But they're getting it done. They're overcoming these challenges and barriers.

當我看到這些數字時，我真正感到鼓舞的是，儘管存在著許多挑戰，但這對醫生來說是大量的時間投入，而且我認為很多醫生，值得稱讚的是，投入這些時間並不一定能得到回報。但他們正在完成它。他們正在克服這些挑戰和障礙。

And that is, I think, what is so important. They see the need when they look at patients who, accomplished people, who are loved by their families, and seeing this dreaded disease pull the patient away from that on a day-by-day basis.

我認為這才是最重要的。當他們看到那些有成就的人、受到家人愛戴的患者，看到這種可怕的疾病日復一日地讓患者遠離這種疾病時，他們就看到了這種需求。

So I do think we are seeing an awful lot of momentum here. And again, I think there's an awful lot of credit to the neurologists and to these centers to overcoming these challenges. And I think that is going to allow us to continue to see quarter-on-quarter growth. It may not be completely linear, and Alisha will go into more detail on that. But it takes time to get these protocols in place. And even when you get the first patient, there has been a tendency to let's have a handful of patients so we get comfortable with the system. But then once they've done all that, then we're starting to see volume pull through.

所以我確實認為我們在這裡看到了巨大的動力。再說一遍，我認為神經科醫生和這些中心克服這些挑戰的功勞非常大。我認為這將使我們能夠繼續看到季度環比增長。它可能不是完全線性的，艾莉莎將對此進行更詳細的介紹。但落實這些協議需要時間。即使當你得到第一個病人時，我們也傾向於讓我們接受少數病人，這樣我們就能適應這個系統。但一旦他們完成了這一切，我們就開始看到成交量的成長。

And one of the interesting things about this launch is that, generally, we look at revenue as a surrogate for demand. And here, there's -- that linkage is not quite so clear because it has taken this upfront time before you see revenue pull through. And I think that's one of the other things we're now seeing in this first quarter, is that we're actually seeing a little bit more of that linkage between demand and revenue. And behind all of this, once those processes are in place and once physicians are ready, there is clearly an underlying demand behind that.

這次發布的一個有趣的事情是，一般來說，我們將收入視為需求的替代品。在這裡，這種聯繫並不那麼明顯，因為在你看到收入成長之前已經花費了這個前期時間。我認為這是我們在第一季看到的其他事情之一，我們實際上看到了需求和收入之間更多的連結。在這一切的背後，一旦這些流程到位並且醫生做好準備，背後顯然存在潛在的需求。

So I think that has given us a lot of confidence to now invest more. We have a 30% expansion in our U.S. field force planned. But I would also say this is a launch that really didn't start until 1st of September. And even then you could argue we weren't fully in the mode of being able to launch because the PET scan reimbursement hadn't been cleared.

所以我認為這給了我們很大的信心，讓我們現在可以進行更多投資。我們計劃將美國現場部隊規模擴大 30%。但我還要說，這是直到 9 月 1 日才真正開始的發布。即便如此，您可能會說我們還沒有完全進入啟動模式，因為 PET 掃描報銷尚未獲得批准。

But our U.S. teams for both Eisai and Biogen have done an awful lot of work to look at the data from the first 7 months of the launch. And really, we're now looking at redeploying some resources here and there as we see what's important and what's not. I think the teams are really working well together. And we have a number of new elements of our promotional mix that will start to come into play as we progress through the second quarter.

但衛材 (Eisai) 和百健 (Biogen) 的美國團隊已經做了大量工作來查看上市前 7 個月的數據。事實上，我們現在正在考慮重新部署一些資源，看看什麼是重要的，什麼是不重要的。我認為這些團隊確實合作得很好。隨著第二季的進展，我們的促銷組合中有許多新元素將開始發揮作用。

So from a Biogen point of view, I think it's too early to put out any forecast. We're going to be looking at those month-over-month new patient starts and the increase in revenue. But I would certainly say, I'm extremely encouraged by the progress that has occurred.

因此，從百健（Biogen）的角度來看，我認為現在做出任何預測還為時過早。我們將關注逐月新增患者的數量和收入的成長。但我肯定會說，我對所取得的進展感到非常鼓舞。

And if I could switch gears to another key growth driver, which is SKYCLARYS, and Alisha again will go into more detail, and I think also just show investors how we're progressing versus other analogs. Because the rare disease market doesn't behave so typically as in other markets. There's always a catch-up population in rare disease. And so it takes a while for that catch-up population to work through the system and then have a look at what's the underlying demand.

如果我可以轉向另一個關鍵的成長動力，即 SKYCLARYS，Alisha 將再次詳細介紹，我認為這也只是向投資者展示我們與其他類似公司相比的進展。因為罕見疾病市場的表現並不像其他市場那麼典型。罕見疾病領域總有追趕人群。因此，追趕人群需要一段時間才能完成該系統，然後看看潛在的需求是什麼。

Remember that these are not patients sitting in waiting rooms and that there is a huge amount of work that goes into finding patients. And I think that is actually one of Biogen's strengths. That's I think what gives me the confidence to continue to invest more, because I do think there is a know-how within Biogen. And that's one of the reasons we want to build out a rare disease franchise.

請記住，這些患者並不是坐在候診室的患者，而且尋找患者需要做大量的工作。我認為這實際上是百健（Biogen）的優勢之一。我認為這讓我有信心繼續進行更多投資，因為我確實認為百健（Biogen）內部擁有專業知識。這就是我們想要建立罕見疾病專營權的原因之一。

But we've got 1,100 patients now on therapy in the U.S. That's a really significant number. But I'm also really encouraged by the launch in Europe. We've already got -- and remember, this drug was only approved in -- at the end of January. And yet we already have 300 patients on treatment. You all know Europe, we have to go country by country to get reimbursement, and we have early access programs. Some of those we can charge revenue for some of them we can't. But we have already submitted reimbursement dossiers in 5 countries in the U.S. So I think Europe will increasingly add to the revenue. It's probably more of a 2025 story than in 2024. But I think if I'm looking at the acceptance and the uptake, then that launch is also off to a successful start.

但現在美國有 1,100 名患者正在接受治療。但我也對歐洲的推出感到非常鼓舞。我們已經——請記住，這種藥物只是在一月底才獲得批准。然而我們已經有 300 名患者正在接受治療。你們都知道歐洲，我們必須逐個國家才能獲得報銷，而且我們有早期訪問計劃。有些我們可以收取收入，有些則不能。但我們已經在美國的5個國家提交了報銷檔案，所以我認為歐洲會越來越多地增加收入。這可能更像是 2025 年的故事，而不是 2024 年的故事。

And we know that there are an awful lot of patients in Latin America, and we've already submitted in Brazil, for example, and submitting in Argentina. And I think that actually is going to be a major benefit and opportunity for us as well. Remember, there are no patients in Asia because this is a genetic disease that really affects people of European descent. And in fact, it was quite interesting, I was talking to a key opinion leader in Germany who has actually done genetic studies. And you basically just follow where the explorers went and that's where you're going to find the patients.

我們知道拉丁美洲有大量患者，例如我們已經在巴西提交了申請，並在阿根廷提交了申請。我認為這對我們來說實際上也將是一個重大的好處和機會。請記住，亞洲沒有患者，因為這是一種真正影響歐洲血統的遺傳疾病。事實上，這很有趣，我正在與德國的一位關鍵意見領袖交談，他實際上做過基因研究。你基本上只要跟著探險家去的地方，那就是你要找到病人的地方。

So I think with that, let's dive in a little bit deeper, and I'll turn it over to Alisha.

所以我想，讓我們更深入地研究一下，然後我將把它交給 Alisha。

Thank you, Chris. Good morning to everyone that's able to join the call today. I'm Alisha Alaimo, and as Chuck shared, I lead our business in North America.

謝謝你，克里斯。今天能夠參加電話會議的所有人早安。我是 Alisha Alaimo，正如 Chuck 所說，我負責領導我們在北美的業務。

This is a really unique period in Biogen's history with multiple first-in-class drug launches in the U.S., which gives us an opportunity to drive our return to growth. And for our team, it's also meaningful to support more people living with Alzheimer's, Friedreich's ataxia and postpartum depression. We thought it might be helpful to provide a perspective on the market dynamics of the launches and share how we're seeking a tailored approach to help provide patients with access to our therapies.

這是百健 (Biogen) 歷史上一個非常獨特的時期，在美國推出了多種一流藥物，這為我們提供了推動恢復成長的機會。對於我們的團隊來說，支持更多患有阿茲海默症、弗里德賴希氏共濟失調症和產後憂鬱症的人也很有意義。我們認為，提供有關產品上市的市場動態的視角並分享我們如何尋求量身定制的方法來幫助患者獲得我們的治療可能會有所幫助。

Let me begin with the Alzheimer's market. As Chris mentioned, we are seeing many major health systems across the country take a deliberate, staged and phased approach, meaning they are setting up their pathways to get patients started with diagnosis, treatment and monitoring. We believe we are now seeing a dynamic where some IDNs are turning the page, and they are focusing on expanding and extending their model.

讓我從阿茲海默症市場開始。正如克里斯所提到的，我們看到全國許多主要衛生系統採取了深思熟慮的、分階段的和分階段的方法，這意味著他們正在建立自己的途徑，讓患者開始診斷、治療和監測。我們相信，我們現在看到的動態是，一些 IDN 正在翻頁，他們專注於擴展和擴展他們的模型。

In Q1, we saw several IDNs across regions scale their patient volume. Among our priority 100 IDNs, units more than tripled in quarter 1 compared to quarter 4, which contributed to the overall estimated patients on therapy increasing approximately 2.5x in quarter 1 versus quarter 4.

在第一季度，我們看到多個地區的 IDN 擴大了患者數量。在我們優先考慮的 100 個 IDN 中，第一季的治療數量比第四季度增加了兩倍多，這使得第一季度接受治療的總體估計患者數量比第四季度增加了約 2.5 倍。

We believe this acceleration in new patients really began to emerge at the end of the quarter. For example, more than 20% of new patients since launch were added in March. Today, among our 100 priority IDNs, more than 80% have approved LEQEMBI through their P&T process, and nearly 85% of those IDNs with approval have placed an order.

我們相信，新患者數量的成長確實在本季末開始顯現。例如，自推出以來超過 20% 的新患者是在 3 月增加的。如今，在我們的 100 個優先 IDN 中，超過 80% 已通過 P&T 流程批准 LEQEMBI，並且在獲得批准的 IDN 中近 85% 已下訂單。

Chris also mentioned that we're seeing more physicians gain experience with LEQEMBI. We saw the number of unique prescribers in quarter 1 double compared to quarter 4. We believe that we're still in the early phases of unlocking the potential to treat a high volume of patients at the priority IDNs. And I thought it might be helpful to share some examples of these dynamics at the site level.

Chris 也提到，我們看到越來越多的醫生獲得了 LEQEMBI 的經驗。我們看到第一季的獨特處方者數量是第四季度的兩倍。我認為在網站層級分享這些動態的一些範例可能會有所幫助。

There is 1 large health system in the Midwest that added LEQEMBI to its formulary in July of last year. 6 months later, entering Q1, the system had ordered only 300 units. However, by the end of March, they had ordered 2,700 units.

中西部有 1 個大型衛生系統於去年 7 月將 LEQEMBI 加入其處方中。 6個月後，進入第一季度，系統僅訂購了300台。然而，到3月底，他們已經訂購了2,700台。

Similar to the example I just shared, there is also a health system in the Southeast that added LEQEMBI to its formulary in August of '23. 5 months later, entering Q1, this system ordered about 560 units. By the end of Q1, this system ordered more than 1,750 units to treat their patients. For context, a local neurologist network in that same region ordered 3,000 units through the same time period, perhaps because they've been able to scale their processes to treat more patients. However, we believe this well-known Southeast IDN is planning to move beyond their flagship site of care to treat at multiple locations, which is another example of the expand-and-extend trend at the IDNs.

與我剛才分享的例子類似，東南部也有一個衛生系統在 23 年 8 月將 LEQEMBI 加入其處方中。 5個月後，進入第一季度，該系統訂購了約560台。截至第一季末，該系統訂購了 1,750 多個設備來治療患者。就背景而言，同一地區的當地神經科醫生網路在同一時間段訂購了 3,000 台，也許是因為他們能夠擴展流程以治療更多患者。然而，我們相信這個著名的東南部 IDN 正計劃超越其旗艦護理中心，在多個地點進行治療，這是 IDN 擴張趨勢的另一個例子。

We believe many systems just now appear to be completing the staging phase, and we think the recent trends observed support our continued belief that LEQEMBI represents a significant commercial opportunity over the mid to longer term.

我們相信許多系統現在似乎正在完成分階段，我們認為最近觀察到的趨勢支持了我們的持續信念，即 LEQEMBI 代表著中長期的重大商業機會。

With access and infrastructure progressing and patient volume accelerating, we believe this is also the right time to expand the field force. Biogen leaders are working to hire a customer-facing field team, which will join Eisai. Simultaneously to activate the patient community, Biogen and Eisai have launched new direct-to-patient and caregiver omnichannel marketing campaigns. These digital programs and point-of-care resources are focused on the already-diagnosed patients who we believe are under the care of a neurologist. With these promising signals emerging, we look forward to providing more updates in the future.

隨著准入和基礎設施的進步以及患者數量的增加，我們相信現在也是擴大現場隊伍的最佳時機。百健（Biogen）領導者正在努力聘請一個面向客戶的現場團隊，該團隊將加入衛材（Eisai）。同時，為了激活患者社區，百健（Biogen）和衛材（Eisai）推出了新的直接面向患者和照護者的全通路行銷活動。這些數位程序和護理點資源主要針對已確診的患者，我們認為這些患者正在接受神經科醫師的照護。隨著這些有希望的訊號的出現，我們期待在未來提供更多更新。

Now moving to SKYCLARYS. We believe we're driving strong performance with the launch as we continue to exceed market penetration rates of most rare disease launch analogs. As of April 19, we now have over 1,100 patients on therapy, with an estimated 4,500 addressable Friedreich's ataxia patients in the U.S., we have achieved 24% market penetration, which exceeds our own strong SPINRAZA launch. As is typical with the rare disease launches, we believe we are now moving beyond the catch-up population to reach additional patients who previously received a diagnosis of or are suspected to have Friedreich's ataxia. Though patient numbers may be uneven, we anticipate adding patients each month.

現在轉移到 SKYCLARYS。我們相信，隨著我們繼續超過大多數罕見疾病類似藥物的市場滲透率，我們的推出將推動強勁的業績。截至4 月19 日，我們現在有超過1,100 名患者正在接受治療，其中美國估計有4,500 名可治療的弗里德賴希共濟失調患者，我們已經實現了24% 的市場滲透率，這超過了我們自己強大的SPINAZA 推出。正如罕見疾病推出的典型情況一樣，我們相信我們現在正在超越追趕人群，接觸到以前被診斷出或懷疑患有更多弗里德賴希共濟失調的患者。儘管患者數量可能參差不齊，但我們預計每個月都會增加患者。

Last quarter, we shared how we've integrated some of our sophisticated rare disease capabilities to drive improvements in access, logistics and patient support. Notably, our market access team continued to make progress with securing favorable policies in quarter 1. Today, nearly 80% of all U.S. pharmacy lives now have SKYCLARYS reimbursement. These patient support and access efforts are critical to help patients start therapy as soon as possible and remain on treatment for the long term.

上季度，我們分享瞭如何整合一些複雜的罕見疾病能力來推動改善進入、物流和病患支援。值得注意的是，我們的市場准入團隊在第一季在確保優惠政策方面繼續取得進展。這些患者支持和獲取工作對於幫助患者盡快開始治療並長期接受治療至關重要。

With a meaningful foundation of patients on therapy, we are focusing on 2 key areas in this next phase of our launch. First, educating community neurologists and PCPs about Friedreich's ataxia and SKYCLARYS. And second, engaging additional appropriate patients. I'll begin with our focus on HCPs.

憑藉患者接受治療的有意義的基礎，我們在下一階段的推出中將重點放在兩個關鍵領域。首先，對社區神經科醫生和 PCP 進行 Friedreich 共濟失調和 SKYCLARYS 的教育。其次，吸引更多合適的患者。我將從我們對 HCP 的關注開始。

Remember, with Friedreich's ataxia, in addition to patients being concentrated at the top centers of excellence, we believe they are also being treated in the community. To support these physicians, we have expanded our field footprint and we are using AI to analyze data to help reach the HCPs who may have untreated patients. With insights into the relevant sites of care and when patients last engage with their physicians, we believe we can help more patients even sooner. And with genetic testing, we anticipate patients can confirm a potential diagnosis and determine if SKYCLARYS is a treatment option.

請記住，對於弗里德賴希的共濟失調，除了患者集中在頂級卓越中心外，我們相信他們也在社區接受治療。為了支持這些醫生，我們擴大了我們的現場覆蓋範圍，並使用人工智慧來分析數據，以幫助接觸可能有未經治療的患者的醫護人員。透過深入了解相關護理場所以及患者最後一次與醫生接觸的時間，我們相信我們可以更快地幫助更多患者。透過基因檢測，我們預計患者可以確認潛在的診斷並確定 SKYCLARYS 是否是治療選擇。

As far as our patient activation focus, we are encouraged by real-world experiences that patients are sharing on social media. As in our experience, these stories can help other diagnose patients. Many of these stories about the impact of SKYCLARYS include reports of slowing of disease progression and, in some cases, even an improvement in their symptoms long term. In addition to these organic stories, we anticipate launching our SKYCLARYS social media campaign soon. So we believe we're off to a strong start, but we know there are more people living with Friedreich's ataxia that we can help, and we look forward to supporting them.

就我們的患者激活重點而言，我們對患者在社交媒體上分享的真實體驗感到鼓舞。根據我們的經驗，這些故事可以幫助其他患者診斷。許多關於 SKYCLARYS 影響的故事都包括減緩疾病進展的報告，在某些情況下，甚至長期改善症狀。除了這些自然故事之外，我們預計很快還會推出 SKYCLARYS 社群媒體活動。因此，我們相信我們已經有了一個良好的開端，但我們知道我們可以幫助更多患有弗里德賴希共濟失調的人，我們期待為他們提供支持。

Which now brings me to ZURZUVAE. As Chris mentioned, we are encouraged by the performance of the launch to date, and we think we are seeing several positive trends with providers, patient experience and reimbursement.

現在我要談談 ZURZUVAE。正如克里斯所提到的，我們對迄今為止的發布表現感到鼓舞，我們認為我們在提供者、患者體驗和報銷方面看到了一些積極的趨勢。

First, let me begin with providers. Across multiple physician types, we believe many providers are demonstrating an urgency to treat. Notably, OB/GYNs led overall prescribing in quarter 1, which we believe is encouraging as they are often the first to see PPD patients. Furthermore, breadth of adoption has continued to grow. In March nearly double the number of HCPs prescribed ZURZUVAE compared to just January. We've seen that some early prescribers require only a few calls before they treat.

首先，讓我從提供者開始。在多種類型的醫生中，我們相信許多提供者都表現出治療的緊迫性。值得注意的是，婦產科醫師在第一季的整體處方中處於領先地位，我們認為這是令人鼓舞的，因為他們往往是最早接診 PPD 患者的。此外，採用的範圍持續擴大。與 1 月相比，3 月開出 ZURZUVAE 處方的 HCP 數量幾乎翻了一番。我們發現，有些早期處方者在治療前只需要打幾次電話。

Keep in mind that ZURZUVAE is a scheduled product available through a specialty pharmacy. While we believe psychiatrists are generally familiar with working with specialty pharmacy, this could be a new process for many OB/GYNs. We're working to educate these providers on the steps required so that they can support their appropriate patients.

請記住，ZURZUVAE 是可透過專業藥局購買的預定產品。雖然我們相信精神科醫生普遍熟悉與專業藥房的合作，但這對許多婦產科醫生來說可能是一個新過程。我們正在努力教育這些提供者了解所需的步驟，以便他們能夠為合適的患者提供支援。

Second, some HCPs have early experience with ZURZUVAE have shared that some of their patients reported significant improvement in depressive symptoms within days of starting treatment. Several patients are sharing their personal 14-day treatment experiences on platforms like TikTok, and we believe their courage to tell their story will help educate other women living with postpartum depression.

其次，一些擁有 ZURZUVAE 早期經驗的 HCP 表示，他們的一些患者在開始治療後幾天內報告憂鬱症狀顯著改善。幾位患者正在 TikTok 等平台上分享她們個人 14 天的治療經歷，我們相信她們講述自己故事的勇氣將有助於教育其他患有產後憂鬱症的女性。

Third, we believe we're making good progress with government and commercial access. Many payers already have policies in place, the majority of which have been favorable, while some others continue to cover ZURZUVAE even without formal policies in place. Two of the three national pharmacy benefit managers are providing coverage for ZURZUVAE without overly burdensome restrictions. We are in active discussions with a third national PBM as we await their decision.

第三，我們相信我們在政府和商業准入方面取得了良好進展。許多付款人已經制定了政策，其中大部分都是有利的，而其他一些付款人即使沒有正式政策，也繼續承保 ZURZUVAE。三個國家藥品福利管理者中的兩個正在為 ZURZUVAE 提供保險，而沒有過於繁瑣的限制。我們正在與第三個國家 PBM 進行積極討論，等待他們的決定。

And while Medicaid tends to take longer, almost half of the states, including several of the largest, accelerated reviews into quarter 1, which we believe is unusual for a process that can typically take up to a year after FDA approval. We are encouraged that approximately 2/3 of Medicaid lives with published policies appear to have minimal access restrictions. We anticipate the remaining states to review coverage throughout 2024, and we will continue to support their reviews as much as possible.

儘管醫療補助往往需要更長的時間，但幾乎一半的州（包括幾個最大的州）將審查加速到第一季度，我們認為這對於FDA 批准後通常需要長達一年的流程來說是不尋常的。令我們感到鼓舞的是，大約 2/3 擁有已公佈政策的醫療補助生活似乎具有最低限度的准入限制。我們預計其餘各州將在 2024 年審查覆蓋範圍，我們將繼續盡可能支持他們的審查。

Before handing it over to Mike, I want to underscore that we have an important responsibility to help people living with Alzheimer's, Friedreich's ataxia and postpartum depression, and we are working with urgency to help these patient communities. We believe we're making significant progress in that mission, and we look forward to continuing to share updates with you. With that, I'd like now to pass it over to Mike.

在將其交給麥克之前，我想強調，我們負有幫助阿茲海默症、弗里德賴希共濟失調和產後憂鬱症患者的重要責任，我們正在緊急努力幫助這些患者社區。我們相信我們正在這項使命中取得重大進展，我們期待繼續與您分享最新消息。現在我想把它交給麥克。

Thank you, Alisha, and hello to everyone. I'd like to start with a high-level overview of our financial profile and how we are seeing this progress in the context of our Fit for Growth program. We maintain a sharp focus on improving profitability as we endeavor to return the company to not just EPS growth but revenue growth as well. Please note that any financial comparisons that I make are versus the first quarter of 2023.

謝謝你，艾莉莎，大家好。我想先對我們的財務狀況以及我們如何在「適合成長」計畫的背景下看到這一進展進行高層次的概述。我們始終高度關注提高獲利能力，努力使公司不僅實現每股收益成長，而且實現收入成長。請注意，我所做的任何財務比較都是與 2023 年第一季相比。

Regarding our top line, our 4 recent launches contributed revenue in the first quarter, which more than offset the 4% decline in our MS business. And as we noted during our previous earnings call and our recent webcast investor conference, we expect that this year's revenue will be skewed more towards the second half of the year, and we expect this to be due to both the timing of shipments for SPINRAZA outside the U.S. as well as the expected growth profiles for our recently launched products.

就我們的收入而言，我們最近推出的 4 款產品為第一季貢獻了收入，這遠遠抵消了我們 MS 業務 4% 的下降。正如我們在先前的財報電話會議和最近的網路廣播投資者會議上指出的那樣，我們預計今年的收入將更偏向下半年，我們預計這是由於 SPINRAZA 的發貨時間美國以及我們最近推出的產品的預期成長概況。

On gross margin, we saw improvement of 5 percentage points in the quarter as our revenue mix has shifted. This is due to increasing high-margin product revenue replacing lower-margin contract manufacturing revenue. We also had $45 million of idle capacity charges in the first quarter of 2023, and none in the first quarter of 2024.

在毛利率方面，由於我們的收入結構發生了變化，本季我們的毛利率提高了 5 個百分點。這是由於高利潤產品收入的增加取代了低利潤合約製造收入。 2023 年第一季我們也產生了 4,500 萬美元的閒置產能費用，而 2024 年第一季則沒有。

Our R&D prioritization and Fit for Growth initiatives had a clear impact on our non-GAAP R&D and SG&A expenses, which we refer to as core OpEx, during the quarter, and that resulted in a 13% decrease year-over-year. These savings contributed to meaningful growth of our non-GAAP operating income of 24% year-over-year.

我們的研發優先順序和適合成長計畫對本季我們的非 GAAP 研發和 SG&A 支出（我們稱之為核心營運支出）產生了明顯影響，導致同比下降 13%。這些節省使我們的非 GAAP 營業收入年增 24%。

Our operating margin was 31% in the quarter as compared to 23% in the first quarter of 2023. And while these are encouraging improvements so far, we believe there is still more work that can be done to continue to improve these metrics.

我們本季的營業利潤率為 31%，而 2023 年第一季為 23%。

Now a bit more color on revenue dynamics during the first quarter. Total revenue was $2.3 billion, which was a decrease of 7% at actual and constant currency. Our MS franchise revenue declined approximately 4% driven by competition and the usual channel seasonality that we see in the first quarter. Within MS, VUMERITY revenue grew 18% and benefited from global patient growth as well as some favorable channel dynamics during the first quarter.

現在對第一季的營收動態有更多的了解。總收入為 23 億美元，以實際和固定匯率計算下降 7%。由於競爭和我們在第一季看到的通常通路季節性因素，我們的 MS 特許經營收入下降了約 4%。在 MS 領域，VUMERITY 收入成長了 18%，受益於全球患者成長以及第一季的一些有利的通路動態。

Regarding TECFIDERA in the EU, we have now seen most generics exit the market, which drove ex U.S. growth of 5% for TECFIDERA this quarter. We continue to believe we are entitled to market protection in the EU until February of 2025.

關於歐盟的 TECFIDERA，我們現在看到大多數仿製藥退出市場，這推動本季 TECFIDERA 在美國以外的市場成長 5%。我們仍然相信，在 2025 年 2 月之前我們有權在歐盟獲得市場保護。

And now a quick double-click on our rare disease revenue for the quarter. SKYCLARYS delivered $78 million of revenue, including approximately $5 million in Europe, where we have launches in several countries underway.

現在快速雙擊我們本季的罕見疾病收入。 SKYCLARYS 實現了 7800 萬美元的收入，其中在歐洲的收入約為 500 萬美元，我們正在歐洲的多個國家/地區推出產品。

For SPINRAZA in the U.S., revenue was up 1% in the quarter, and we remain encouraged by the resilience here. SPINRAZA revenue outside the U.S. declined 35%. The majority of this year-over-year decline was due to shipment timing in certain emerging markets. We continue to generally see stable patient numbers globally, and we would expect the shipping dynamic outside the U.S. to largely normalize throughout the remainder of 2024. We also saw some modest negative impacts from competition and foreign exchange in the quarter. For the full year 2024, we expect global SPINRAZA revenue to decline by a low single-digit percentage.

對於美國的 SPINRAZA，該季度的收入成長了 1%，我們仍然對這裡的韌性感到鼓舞。 SPINRAZA 在美國以外的收入下降了 35%。年比下降的主要原因是某些新興市場的出貨時間。我們總體上繼續看到全球患者數量保持穩定，我們預計美國以外的運輸動態將在 2024 年剩餘時間內基本正常化。對於 2024 年全年，我們預計 SPINRAZA 的全球收入將出現較低的個位數百分比下降。

ZURZUVAE delivered $12 million of revenue, which we believe is inclusive of some channel stocking in anticipation of increasing demand, which is common for any new launch.

ZURZUVAE 實現了 1,200 萬美元的收入，我們認為其中包括一些因預期需求增加而進行的通路備貨，這對於任何新產品的推出都很常見。

And lastly, contract manufacturing revenue was notably lower year-over-year. And as we reflected in our guidance for the full year, we continue to expect contribution from this line to be significantly lower than last year due to completing a number of batch commitments in 2023.

最後，合約製造收入較去年同期顯著下降。正如我們在全年指導中所反映的那樣，由於 2023 年完成了一些批量承諾，我們仍然預計該生產線的貢獻將顯著低於去年。

First quarter non-GAAP cost of sales was 22% of total revenue, and that's an improvement of 5 percentage points. As I previously mentioned, this improvement was driven by a more favorable product mix as revenue from new product launches replaced lower margin contract manufacturing revenue. And it also was related to having lower idle capacity charges. We did not have any in the first quarter of 2024.

第一季非 GAAP 銷售成本佔總收入的 22%，提高了 5 個百分點。正如我之前提到的，這種改善是由更有利的產品組合推動的，因為新產品發布的收入取代了利潤率較低的合約製造收入。這也與閒置產能費用較低有關。 2024 年第一季我們沒有。

First quarter non-GAAP R&D expense decreased $124 million, which was driven primarily by savings achieved from Fit for Growth, where we remain on track to achieve cost savings of $1 billion gross and $8 million net of investment by the end of 2025. We also saw savings as a result of our R&D portfolio prioritization, which has had a meaningful impact as we discontinued some programs and have focused our spend on areas we believe have a higher probability of success.

第一季非 GAAP 研發費用減少了 1.24 億美元，這主要是由於 Fit for Growth 實現的節省，我們仍有望在 2025 年底前實現總成本節省 10 億美元和淨投資 800 萬美元。順序節省了開支，這產生了有意義的影響，因為我們停止了一些項目，並將支出集中在我們認為成功機率更高的領域。

Non-GAAP SG&A expense decreased approximately $33 million in the first quarter, and this was primarily due to $50 million of G&A-related cost reductions, which were realized in 2024 in connection with our Fit for Growth program. And that was offset by an increase in operational spending on sales and marketing activities in support of the LEQEMBI and SKYCLARYS launches. I will also note that the prior year included $31 million related to the termination of a co-promote agreement for our MS products in Japan.

第一季非 GAAP SG&A 費用減少了約 3,300 萬美元，這主要是由於我們的 Fit for Growth 計劃於 2024 年實現了 5,000 萬美元的 G&A 相關成本削減。但這被支持 LEQEMBI 和 SKYCLARYS 發布的銷售和行銷活動營運支出的增加所抵消。我還要指出的是，上一年包括與終止我們在日本 MS 產品的共同推廣協議相關的 3,100 萬美元。

All of this together contributed to non-GAAP operating income growing 24%, with non-GAAP operating margin now above 30% and improving, and non-GAAP EPS growth of 8%.

所有這些共同推動非 GAAP 營業收入成長 24%，非 GAAP 營業利潤率現已超過 30% 並有所改善，非 GAAP 每股收益成長 8%。

Next, a brief update on our balance sheet. We ended the quarter with approximately $6.5 billion of debt, $1.1 billion in cash and marketable securities, and net debt of roughly $5.5 billion.

接下來，簡要更新我們的資產負債表。本季結束時，我們的債務約為 65 億美元，現金和有價證券為 11 億美元，淨債務約 55 億美元。

As of March 31, 2024, the $6.5 billion of total debt included $250 million of the $1 billion 2023 term loan, which was put in place at the time of the Reata acquisition. As of March 31, 2024, we had repaid $750 million of this $1 billion facility. The remaining $250 million is expected to be repaid during the second quarter of this year, so this quarter, earlier than our original expectation which was by the end of this year. I'd note that this cash and marketable securities figure does not include a $437 million payment from Samsung, which we received earlier this month.

截至 2024 年 3 月 31 日，65 億美元的總債務包括 2023 年 10 億美元定期貸款中的 2.5 億美元，該貸款是在收購 Reata 時到位的。截至 2024 年 3 月 31 日，我們已償還了這筆 10 億美元貸款的 7.5 億美元。剩餘的 2.5 億美元預計將在今年第二季償還，因此這個季度比我們原來的預期（今年年底）要早。我要指出的是，這個現金和有價證券數字不包括我們本月早些時候收到的三星支付的 4.37 億美元。

We continued to generate strong free cash flow during the first quarter with approximately $507 million of free cash flow. So overall, our balance sheet remains in a strong position with increasing capacity to invest in growth initiatives.

第一季我們持續產生強勁的自由現金流，自由現金流約 5.07 億美元。因此，整體而言，我們的資產負債表仍處於強勢地位，投資成長計畫的能力不斷增強。

And regarding our strategic review of the biosimilars business. At this point, we have not received an acceptable offer from a third party. Our process remains ongoing, and we will remain disciplined as we continue to explore all options, including retaining the business.

關於我們對生物相似藥業務的策略性審查。目前，我們尚未收到第三方可接受的報價。我們的流程仍在繼續，我們將繼續遵守紀律，繼續探索所有選擇，包括保留業務。

Next, I'd like to discuss our full year 2024 guidance ranges and assumptions. We are reaffirming our expectation of full year 2024 non-GAAP diluted earnings per share of between $15 and $16, which reflects expected growth of approximately 5% at the midpoint of the range as compared to 2023. All of the previous assumptions to our guidance, including those you see on this slide, remain unchanged.

接下來，我想討論我們 2024 年全年的指導範圍和假設。我們重申，我們對2024 年全年非GAAP 攤薄每股收益的預期為15 至16 美元，這反映出與2023 年相比，該範圍中點的預期增長約為5%。假設，包括您在這張投影片上看到的內容，保持不變。

I'd like to remind that we have potential R&D success milestone or opt-in payments associated with the upcoming clinical data readouts, and we have made an allowance for some of these potential payments in our guidance. Of course, whether or not they are paid will be dependent on the data and our resulting decisions.

我想提醒一下，我們有潛在的研發成功里程碑或與即將到來的臨床數據讀出相關的選擇加入付款，並且我們在我們的指南中對其中一些潛在付款進行了準備。當然，他們是否獲得報酬將取決於數據和我們最終的決定。

And finally, we just announced the completion of a sale of 1 of our 2 priority review vouchers for $103 million. At this point, we expect to earmark these proceeds for business investment or to support business development opportunities as they arise.

最後，我們剛剛宣布以 1.03 億美元的價格完成了 2 張優先審核優惠券中的 1 張的銷售。目前，我們預計將這些收益專門用於商業投資或支持出現的業務發展機會。

And in closing, we remain committed to our #1 goal of returning Biogen to sustainable top and bottom line growth and creating long-term value for our shareholders. We will now open up the call for questions.

最後，我們仍然致力於實現我們的第一目標，讓百健恢復可持續的營收和利潤成長，並為我們的股東創造長期價值。我們現在將開放提問。

Thanks, Mike. Jennifer, can we go to questions?

謝謝，麥克。詹妮弗，我們可以提問嗎？

(Operator Instructions) Your first question comes from the line of Eric Schmidt with Cantor Fitzgerald.

（操作員說明）您的第一個問題來自埃里克·施密特（Eric Sc​​hmidt）與坎托·菲茨杰拉德（Cantor Fitzgerald）的對話。

I guess on LEQEMBI, and maybe for Priya, we had a couple of updates in the last month or so, the EMEA delay on the CHMP recommendation. And also I know this is your partner's doing, but Eisai announced that they couldn't submit for the subcu approval until they finished the immunogenicity study. I was hoping you could just update us on time lines for both of those initiatives going forward.

我想在 LEQEMBI 上，也許還有 Priya 上，我們在上個月左右進行了一些更新，歐洲、中東和非洲 (EMEA) 對 CHMP 建議的延遲。我也知道這是你的合作夥伴所做的，但衛材宣布，在完成免疫原性研究之前，他們無法提交 subcu 批准。我希望您能為我們提供這兩項舉措的最新時間表。

Yes. Thanks, Eric. So maybe I can just start off by saying that we are working with Eisai to really provide patients with the optionality of the subcutaneous formulation. Our approach is entirely data-driven. So we were very encouraged to see the bioequivalents we met last year, and we shared that at CTAD. This was the most important milestone. Thereafter, we've engaged with the FDA.

是的。謝謝，埃里克。因此，也許我可以先說，我們正在與衛材合作，真正為患者提供皮下製劑的選擇。我們的方法完全是數據驅動的。因此，當我們看到去年遇到的生物等效物時，我們感到非常鼓舞，我們在 CTAD 上分享了這一點。這是最重要的里程碑。此後，我們與 FDA 進行了接觸。

And currently, just to characterize how we are approaching this, we've split our strategy for subcutaneous formulation. First and foremost, we are working to submit a rolling submission for subcutaneous auto-injector for maintenance. This we're going to do at earliest. Eisai has already submitted a fast-track application. We're awaiting that. And as soon as we get it, we will make the submission. While we continue to generate the data for the 3-month immunogenicity that the FDA has required.

目前，為了描述我們如何實現這一目標，我們將皮下製劑的策略分開。首先也是最重要的，我們正在努力提交皮下自動注射器維護的滾動提交。這是我們最早要做的事。衛材已經提交了快速通道申請。我們正在等待這一點。一旦我們收到，我們就會提交。同時我們繼續產生 FDA 要求的 3 個月免疫原性數據。

Second, because our exposure with subcutaneous formulation was higher than the IV formulation, we believe it's in the interest of patients to optimize dose, and that will lead to more convenience. So we are optimizing the dose, and that is something that is already ongoing and is currently ongoing this year.

其次，由於我們皮下製劑的暴露量高於靜脈注射製劑，因此我們相信優化劑量符合患者的利益，這將帶來更多便利。因此，我們正在優化劑量，這已經在進行中，並且今年仍在進行中。

In terms of time lines, if we get the fast track for subcutaneous maintenance, we will file immediately for rolling review, and that we expect would be in this year even if we don't get the fast track because we have completed the 3-month immunogenicity data by Q4.

就時間軸而言，如果我們獲得皮下維護的快速通道，我們將立即申請滾動審查，即使我們沒有獲得快速通道，我們預計也會在今年進行，因為我們已經完成了 3-第四季度的月免疫原性數據。

Second, for the subcutaneous induction therapy, we expect that we would file by the first quarter of 2026. That is what Eisai has already communicated in their investor comments early March.

其次，對於皮下誘導療法，我們預計將在 2026 年第一季之前提交申請。

I'd also like to remind us that we completed our intravenous maintenance filing by Q1 2024 as we had aimed. Thank you.

我還想提醒我們，我們按照目標在 2024 年第一季完成了靜脈維持備案。謝謝。

We'll go next to Paul Matteis with Stifel.

我們將和史蒂菲爾一起去保羅馬蒂斯旁邊。

I was wondering if we could get your updated perspective on business development as it relates to capacity, therapeutic area, stage of development or commercial. And just in the context of this, how the kind of uncertain promising but uncertain trajectory of lecanemab influences your appetite to execute on something now versus maybe wait a bit until 2025.

我想知道我們是否可以獲得您對業務發展的最新看法，因為它涉及產能、治療領域、發展階段或商業。正是在這種背景下，lecanemab 那種不確定的前景和不確定的軌跡如何影響你現在執行某些事情的意願，而不是等到 2025 年。

Thanks, Paul. I think this year, we're going to be focused on business development to bring in some new assets, both into early-stage research and development. We have always called ourselves a neuroscience company, but the reality of neuroscience is that this is a high-risk area. We don't always understand the underlying disease biology. The disease has progressed slowly. That leads you to some very long and expensive trials. You can't often do a proof-of-concept study in Phase II.

謝謝，保羅。我認為今年，我們將專注於業務發展，並引入一些新資產，包括早期研發。我們一直自稱為神經科學公司，但神經科學的現實是這是一個高風險領域。我們並不總是了解潛在的疾病生物學。病情進展緩慢。這會導致你進行一些非常漫長且昂貴的試驗。您不能經常在第二階段進行概念驗證研究。

And so while we remain committed to neuroscience, my personal view is that I think that is too -- that is not diversified enough for a company of our size. And it's already last year, signaled that we'd like to go into some adjacencies in rare disease. I think we actually have a tremendous commercial capability in rare disease. There are special commercial requirements, the need sometimes to support diagnosis, all of the hurdles with payers that have to be overcome and, of course, finding the patients. And there are an awful lot of tools that I think we have to be able to do that.

因此，儘管我們仍然致力於神經科學，但我個人的觀點是，對於我們這樣規模的公司來說，這還不夠多元化。去年就已經表明我們想要進入罕見疾病的一些領域。我認為我們在罕見疾病方面實際上擁有巨大的商業能力。有特殊的商業要求，有時需要支持診斷，必須克服付款人的所有障礙，當然還有尋找患者。我認為我們必須有很多工具才能做到這一點。

And then immunology. We've been an immunology company since the get-go since MS is really an autoimmune disease. So I think we'll use the opportunity with licensing collaborations to expand that. I think where our balance sheet is, if something really extraordinary came along, we'd look at it. But I don't think where we sit right now, we'd be thinking about doing anything this year on an acquisition front, not certainly have any size. But Mike, maybe you can talk to the balance sheet capability.

然後是免疫學。我們從一開始就是一家免疫學公司，因為多發性硬化症其實是一種自體免疫疾病。因此，我認為我們將利用許可合作的機會來擴大這一範圍。我認為我們的資產負債表在哪裡，如果出現真正非凡的事情，我們會關注它。但我認為我們現在不會考慮今年在收購方面做任何事情，當然不會有任何規模。但是麥克，也許你可以談談資產負債表的能力。

Yes. So Paul, I would just comment that our balance sheet is in a very good spot. If you look at our net debt position at the end of the first quarter and then you pro forma that for the Samsung payment and the paydown that we'll make in the second quarter on the term loan, it's about $5 billion of net debt. We generate about $3 billion of EBITDA. So it's only about somewhere between 1.5 turns and 2 turns of leverage. So we certainly could add another turn of leverage for something that we liked, at least temporarily, and we generate a couple of billion dollars of free cash flow per year.

是的。所以保羅，我只想評論說我們的資產負債表處於非常好的位置。如果你看看我們第一季末的淨債務頭寸，然後按形式計算三星付款以及我們將在第二季度支付的定期貸款的還款額，淨債務約為 50 億美元。我們產生約 30 億美元的 EBITDA。所以槓桿作用大約只有 1.5 圈到 2 圈之間。因此，我們當然可以為我們喜歡的東西增加另一輪槓桿，至少暫時如此，我們每年會產生數十億美元的自由現金流。

So I think about it in the context of 2024 as maybe a $4 billion to $5 billion of capacity sort of number for things that we might be really interested in. And then if you were looking at something more Reata-like, that's probably a little more logical capacity-wise in 2025 or beyond.

因此，我認為，到 2024 年，我們可能真正感興趣的事情可能會達到 40 億至 50 億美元的容量數字。的容量更加合理。

We'll go next to Salveen Richter with Goldman Sachs.

接下來我們將討論高盛的薩爾文·里克特 (Salveen Richter)。

For SKYCLARYS, could you speak to the 2024 outlook and any bolus dynamics that has impacted this? And specifically, you've talked about being a 24% U.S. market penetration, how are you thinking about peak penetration in the U.S. and then the expectations for pace of uptake in Europe and net pricing there?

對於 SKYCLARYS，您能否談談 2024 年的前景以及影響這一前景的任何推注動態？具體來說，您談到了美國市場滲透率為 24%，您如何看待美國的峰值滲透率，以及對歐洲吸收速度和淨定價的預期？

Alisha, you want to take U.S. and I can follow up with Europe?

艾莉莎，你想進入美國，我可以跟進歐洲嗎？

Yes. I think when you look at the U.S. and the market penetration, and you probably saw on the analogs on the slide that the launch has gone very well thus far. And as I also said, we've made it through sort of the catch-up population. We have a lot of really good things in place right now that we are launching in parallel, to identify and hopefully get to the rest of the population.

是的。我認為，當您查看美國和市場滲透率時，您可能會在幻燈片上的類似內容中看到，到目前為止，發布進展非常順利。正如我也說過的，我們已經透過了某種追趕人口的方式實現了這個目標。我們現在有很多非常好的事情，我們正在並行啟動，以識別並希望惠及其他人群。

The way in which we think about this market, though, is we do have 2 sets of patients. You have sets that are highly engaged with their physicians, and you have another set who haven't been engaged probably over the last 2 to 5 years. We have enough data and analytics to understand exactly where these physicians are and how the patients have moved through them. And so with that, we are now identifying a lot of these offices, especially in the community who could have a patient or 2 that might be diagnosed with general ataxia, but not Friedreich's. And so what I referred to earlier on the call is expand the field force footprint, we have a very targeted approach to these offices, in order to, again, increase the market penetration.

不過，我們思考這個市場的方式是，我們確實有兩組患者。有些組別與醫生高度互動，而另一組可能在過去 2 到 5 年裡沒有參與過。我們有足夠的數據和分析來準確了解這些醫生在哪裡以及患者如何通過他們。因此，我們現在正在確定許多這樣的辦公室，特別是在社區中，可能有一個或兩個可能被診斷為一般性共濟失調的患者，但沒有弗里德賴希的患者。因此，我之前在電話會議中提到的是擴大現場人員的足跡，我們對這些辦事處採取了非常有針對性的方法，以便再次提高市場滲透率。

Now as you see with something like a SPINRAZA, we've also performed very well and also have driven quite a good market penetration with that product, even though there's competitors in the marketplace. With SKYCLARYS, with no competitor really in the market, we expect to continue over the next several years to penetrate this for as far as we can go. We know there are 4,500 approximate patients that could have Friedreich's ataxia, and so what we're doing is planning everything that we can to get to as many of them as quickly as possible.

現在，正如您所看到的，像 SPINRAZA 這樣的產品，我們也表現得非常好，並且透過該產品推動了相當好的市場滲透，儘管市場上存在競爭對手。對於 SKYCLARYS，由於市場上沒有真正的競爭對手，我們預計將在未來幾年內繼續盡可能深入滲透這一領域。我們知道大約有 4,500 名患者可能患有弗里德賴希共濟失調症，因此我們正在做的就是盡一切努力盡快救治盡可能多的患者。

Thanks, Alisha.

謝謝，艾莉莎。

Yes. And on Europe, in some ways, the single-payer systems actually are really ideal for rare diseases. A lot of patients in the U.S., even if you have reimbursement, even if you have insurance coverage, there are an awful lot of hurdles that the U.S. health care system imposes on patients. And a lot of those we don't really see in Europe. And so I think we're seeing a rapid uptake. Again, there's a catch-up population. So there's -- and there's a difference between patients on treatment and revenue-generating patients.

是的。在歐洲，從某些方面來說，單一支付系統實際上非常適合罕見疾病。美國的許多病人，即使你有報銷，即使你有保險，美國的醫療保健系統給病人設置了很多障礙。其中很多我們在歐洲並沒有真正看到。所以我認為我們看到了快速的採用。再一次，人口追趕。因此，接受治療的患者和創收患者之間存在差異。

So first, we have actually the commercial launch in Germany because we can get reimbursement relatively quickly. Other countries will come online as we go through the individual country reimbursement processes. But our objective is actually build up to patients. So there's a number who are on free drug at the moment through these EAPs. Some of the EAPs you can charge for. So it's going to be a little lumpy as we look at the revenue line, but I'd say we're extremely encouraged by the uptake of patients.

首先，我們實際上在德國進行了商業發布，因為我們可以相對快速地獲得報銷。當我們完成各國的報銷流程時，其他國家也將上線。但我們的目標實際上是為患者服務。因此，目前有許多人透過這些 EAP 獲得免費藥物。您可以對某些 EAP 進行收費。因此，當我們查看收入線時，它會有點不穩定，但我想說，我們對患者的接受程度感到非常鼓舞。

And then ex U.S., in Latin-America, that could well be a story for 2025. I think you may see our first launch in Brazil in the early part of 2025.

然後在美國以外的拉丁美洲，這很可能是 2025 年的故事。

We'll go next to Umer Raffat with Evercore.

接下來我們將與 Evercore 一起前往 Umer Raffat。

I have one for Priya, if I may. I know there's the late-stage lupus readout with the CD40 ligand antibody this summer. I also realized the time point on this readout is week 48 instead of week 24. And I guess my question is, knowing that there wasn't a clear dose response on efficacy in the prior trial, could you speak to how the B cell impact was different between doses and whether the prolonged duration could actually help the B cell impact in this upcoming readout?

如果可以的話，我為 Priya 準備了一份。我知道今年夏天有 CD40 配體抗體的晚期狼瘡讀數。我還意識到這個讀數的時間點是第 48 週而不是第 24 週。間存在差異，延長持續時間是否真的有助於B 細胞在即將到來的讀數中產生影響？

Thanks, Umer. We have looked at the Phase II study very carefully. And we have decided and we included the 48-week endpoint on BICLA for this Phase III study. And ultimately, we're looking for a meaningful change on the primary endpoint and the key secondary endpoints for SLE such as severe flare prevention and patients achieving low disease activity.

謝謝，烏默。我們非常仔細地研究了第二階段研究。我們已經決定將 BICLA 的 48 週終點納入這項 III 期研究。最終，我們正在尋找 SLE 主要終點和關鍵次要終點的有意義的改變，例如預防嚴重耀斑和實現低疾病活動度的患者。

We also think that the BICLA is a sensitive clinically meaningful composite measure of SLE disease activity and requires disease improvement across all body systems with moderate or severe baseline activity without worsening and the need for escalation in background medication. So we've modified the trial. We are -- we have refined the population. And we think that this is going to be really important as we kind of look forward to the readout.

我們也認為，BICLA 是SLE 疾病活動性的一種敏感的、具有臨床意義的綜合衡量標準，需要所有身體系統的疾病得到改善，具有中度或重度基線活動性，且不會惡化，並且需要增加背景藥物治療。所以我們修改了試驗。我們——我們已經改善了人口。我們認為這將非常重要，因為我們有點期待讀數。

The other piece, I think, here to keep in mind is that we considered how we can modify the population for the study and get to an answer really quickly to bring potentially dapi to patients. So I hope that, that answers your question.

我認為，要記住的另一件事是，我們考慮瞭如何修改研究人群，並快速找到答案，為患者帶來潛在的 dapi。所以我希望這能回答你的問題。

We'll go next to Michael Yee with Jefferies.

接下來我們將與 Jefferies 一起前往 Michael Yee。

I wanted to revisit SKYCLARYS comments. I know you said you were planning to add patients month-to-month. Can you just talk about the trajectory of SKYCLARYS this year as it relates to also any offsets like discontinuation rates, et cetera, et cetera, how does that factor into it? And also, will you book Germany revenues this year? So just talk about the dynamics of revenues for SKYCLARYS.

我想重新審視 SKYCLARYS 的評論。我知道您說過您計劃每月增加患者。您能否談談 SKYCLARYS 今年的發展軌跡，因為它​​也與停產率等任何補償相關，這如何影響其中？另外，您會記錄今年德國的收入嗎？那就來談談SKYCLARYS的收入動態吧。

And if I may sneak in one clarification, Priya said subcu induction filing for LEQEMBI Q1 '26. I just wanted to clear that's what she said.

如果我可以偷偷地澄清一下，Priya 說 LEQEMBI Q1 '26 的 subcu 感應歸檔。我只是想澄清她是這麼說的。

Yes. The outcome and the filing will be in that period. But we'll communicate more on this once we optimize the dose and we go forward.

是的。結果和歸檔將在該期間進行。但一旦我們優化劑量並繼續前進，我們將就此進行更多溝通。

Okay. And SKYCLARYS?

好的。還有SKYCLARYS？

Yes. So for SKYCLARYS, it is quite complicated month-to-month, I will say, because you have patients, obviously, that we're getting via the start forms, which I will say, for the highly engaged population, we are pretty much maxing that out now. We absolutely know who they are, and we've captured them through the physicians.

是的。因此，對於 SKYCLARYS 來說，每個月的情況都非常複雜，我會說，因為你有一個患者，顯然，我們正在通過啟動表格，我會說，對於高度參與的人群，我們幾乎現在就最大限度地利用它。我們絕對知道他們是誰，並且我們已經透過醫生抓獲了他們。

But then you're also going to have a discontinuation rate as you have noted. And you're going to have patients that are being pulled off the start forms putting on to product. And then, of course, you may have them miss a dose or 2, right? So then there's compliance.

但正如您所指出的，您也會有一個停藥率。您將讓患者從開始表格中取出並使用產品。然後，當然，你可能會讓他們漏服一劑或兩劑，對吧？那就有了合規性。

So month-to-month, that will be lumpy because you can say you add 50 patients, but then you have other dynamics going on in the patient population. But what our outlook is for the year, which I can't give you a specific number, is that we are going to continue to add every single month. We are able to find those patients in the community and there are other puts and takes in those numbers. But at the end of the day, we will ensure that we are still leading the rare disease analogs and that we're going to generate market penetration.

因此，每個月的情況都會很不穩定，因為您可以說您添加了 50 名患者，但隨後患者群體中發生了其他動態。但我們對今年的展望是，我無法給你具體的數字，我們將繼續每個月增加。我們能夠在社區中找到這些患者，而這些數字還有其他的投入和吸收。但最終，我們將確保我們仍然領先於罕見疾病類似物，並且我們將實現市場滲透。

Yes. And in Europe, we're booking revenue now for Germany. And actually, we've actually launched in Austria and the Czech Republic as well. And in some countries, we're actually able to charge for the early access programs in Europe and some of that revenue will come down, too. But you probably see more full EU as a region revenue in 2025, but there will be certainly revenue contributions in 2024 from certain countries in Europe.

是的。在歐洲，我們現在正在為德國預訂收入。事實上，我們也在奧地利和捷克共和國推出了這款產品。在某些國家/地區，我們實際上可以對歐洲的早期訪問計劃收取費用，其中一些收入也會下降。但您可能會看到 2025 年歐盟作為一個地區的收入會更加完整，但 2024 年肯定會有來自歐洲某些國家的收入貢獻。

We'll go next to Colin Bristow with UBS.

接下來我們將介紹瑞銀集團的 Colin Bristow。

Maybe one on the LEQEMBI commercial setup. So what investor concern or important feedback we've been hearing from physicians is around there being less sales and marketing presence than perhaps had been expected. I heard in your prepared remarks, you're saying you expect a 30% increase from the U.S. footprint. Are you able to sort of quantify the current U.S. commercial footprint? And was the 30% increase always planned or was it based on some review that the current footprint wasn't adequate?

也許是 LEQEMBI 商業設定上的一個。因此，投資者的擔憂或我們從醫生那裡聽到的重要回饋是，銷售和行銷活動比預期的要少。我在您準備好的演講中聽說，您預計美國的足跡將增加 30%。您能量化當前美國的商業足跡嗎？ 30% 的成長是一直計劃好的還是基於一些審查認為當前的足跡不夠？

Thank you very much for the question. If you really take a step back and look at how we strategically looked at this launch, we always said that we're going to do in a stepwise approach. We knew from the beginning that sites were going to take a while to get up and running. We had to wait for several indicators from CMS giving full approval and NCD being overturned for PET. And so with that being said, we didn't want to go out of the gate with a really huge field force that wasn't able to actually impact or penetrate the market.

非常感謝你的提問。如果你真的退一步看看我們如何從策略上看待這次發布，我們總是說我們將採取逐步的方法。我們從一開始就知道網站需要一段時間才能啟動和運行。我們必須等待 CMS 的多項指標完全批准，並等待 PET 推翻 NCD。話雖如此，我們不想帶著一支無法真正影響或滲透市場的龐大現場力量走出大門。

So instead, what was decided is we went in with a very focused approach. We focused on really the top accounts that we think handle the majority of the diagnosed patients, especially that are under neurology care. And we said once the market gets to a place where we think it's ready for expansion, then we will expand.

因此，我們決定採取一種非常集中的方法。我們真正關注的是我們認為處理大多數確診患者的頂級帳戶，尤其是接受神經科護理的患者。我們說過，一旦市場達到我們認為已準備好擴張的水平，我們就會擴張。

Now to your comment about physicians coming back saying they're not seeing a lot of sales efforts, I think we also have to have really the context of getting these sites up and running takes a lot of effort. And you also don't want to have 3, 4, 5 different people going into these accounts to support. And so we've been very focused on really getting the large IDNs up and running. Some of these centers that have come forward that really could move quite quickly, we got them up and running.

現在，關於醫生回來後說他們沒有看到很多銷售工作的評論，我認為我們還必須真正了解建立和運行這些網站需要付出很多努力的背景。而且您也不希望有 3、4、5 個不同的人進入這些帳戶來提供支援。因此，我們一直非常專注於真正讓大型 IDN 啟動並運行。其中一些已經挺身而出的中心確實可以很快地發展，我們讓它們啟動並運行。

And now as you see the expansion take place with the 30%, we are going to focus mainly on the large IDNs that are now opening up their expand and extend satellite offices where they're now going to allow a larger cohort of patients to come through for diagnosis and treatment. And so with this next phase of a build, which we believe we've done a lot of analytics behind it, and we've had a lot of third parties weigh in on what is the appropriate sizing, we and Eisai believe that this is going to be the right footprint to drive the next acceleration of growth.

現在，正如您所看到的，30% 的擴張正在發生，我們將主要關注大型 IDN，這些機構現在正在開放其擴展和擴展衛星辦公室，他們現在將允許更多的患者前來通過進行診斷和治療。因此，在下一階段的構建中，我們相信我們已經在其背後做了很多分析，並且我們已經有很多第三方對合適的尺寸進行了權衡，我們和衛材認為這是將成為推動下一次加速增長的正確足跡。

And let me just turn it to Priya for a clarification back to Mike Yee's question on...

讓我把它轉給 Priya 來澄清一下 Mike Yee 的問題…

Thank you. Just wanted to clarify that it's the outcome by fiscal year -- Eisai fiscal year '25, which is Q1 2026, for the subcutaneous induction. Of course, that -- it could be a range because it would involve sBLA, potentially a priority review and other such aspects which could shift it. But that is the -- that is what Eisai has communicated. I just wanted to reaffirm that.

謝謝。只是想澄清一下，這是按財政年度（衛材第 25 財政年度，即 2026 年第一季）皮下誘導的結果。當然，這可能是一個範圍，因為它將涉及 sBLA、可能的優先審查以及其他可能改變它的方面。但這就是衛材所傳達的訊息。我只是想重申這一點。

The outcome and not the filing. Obviously, earlier.

結果而不是備案。顯然，更早。

Earlier.

早些時候。

Yes. Thanks, Priya.

是的。謝謝，普里亞。

We'll go next to Brian Abrahams with RBC Capital Markets.

接下來我們將採訪加拿大皇家銀行資本市場部的布萊恩‧亞伯拉罕斯 (Brian Abrahams)。

With regards to LEQEMBI subcu, on the FDA request for immunogenicity data, I'm curious if you have a sense as to what drove that request. Your level of confidence that the PK will be linear using half the subcu dose? And then when are you proposing that patients in their course of treatment should transition from an IV to a subcu maintenance?

關於 LEQEMBI subcu，根據 FDA 要求的免疫原性數據，我很好奇您是否了解是什麼推動了這項要求。您對使用一半 subcu 劑量時 PK 呈線性的信心程度如何？那麼您何時建議治療過程中的患者應該從 IV 過渡到 subcu 維持？

Thanks, Brian. So overall, we -- as you know, we had tested the 720 milligrams in the naive patient population that was in the Clarity AD open-label extension substudy for subcutaneous. Now from that, in addition to that, we had modeling data, and this is what we are proposing for 360 milligrams to be the weekly maintenance. And the FDA is just requiring additional immunogenicity data. We see this as a reasonable request, and we are already in the process of generating it.

謝謝，布萊恩。因此，總的來說，如您所知，我們在 Clarity AD 皮下開放標籤擴展子研究中的初治患者群體中測試了 720 毫克。除此之外，我們還有建模數據，這就是我們建議每週維持 360 毫克的劑量。 FDA 只是需要額外的免疫原性數據。我們認為這是一個合理的請求，我們已經在產生它的過程中。

So overall, we don't expect that the bioequivalence is going to be in question. This is now really about the immunogenicity and actually generating all patients who would be tested for this. So that's what we expect with that.

因此總的來說，我們預期生物等效性不會受到質疑。現在這實際上是關於免疫原性，並且實際上產生了所有將接受免疫原性測試的患者。這就是我們的期望。

Can you remind me what was the second aspect of your question?

你能提醒我你問題的第二個面向是什麼嗎？

When are you proposing that patients transition from the IV to the subcu maintenance? Is there data supporting what -- when in the course of treatment that transition should happen?

您何時建議患者從 IV 過渡到 subcu 維持？是否有數據支持在治療過程中何時應該發生這種轉變？

Yes. And I think that's important because we have filed for an intravenous maintenance, like we already completed this filing Q1 '24. And really, that has come from 3 lines of evidence. The Study 201, which was a Phase II study, the gap period modeling, as well as open-label extension in the Phase III. So that's what's informed our maintenance IV filing. And really, it will be decided along with the FDA on what is the appropriate time for transition from IV, biweekly to weekly, now -- to 4 weekly. And in addition, following that, we'll have the subcutaneous maintenance discussion.

是的。我認為這很重要，因為我們已經申請了靜脈維持治療，就像我們已經在 24 年第一季完成了這份申請一樣。事實上，這來自三方面的證據。研究 201，這是一項 II 期研究，間隙期建模，以及 III 期的開放標籤擴展。這就是我們的維護 IV 歸檔的內容。實際上，它將與 FDA 一起決定從靜脈注射、每兩週一次過渡到每週一次、現在到每週四次的適當時間。此外，接下來我們將討論皮下保養。

So really, it's very systematic and we need to first get through all the IV maintenance. And in parallel, we have the SC maintenance. I hope that makes sense.

所以說真的，這是非常系統化的，我們需要先完成所有的 IV 維護。同時，我們還有 SC 維護。我希望這是有道理的。

We'll go next to Jay Olson with Oppenheimer.

接下來我們將和奧本海默一起去傑·奧爾森。

Thanks for providing this update. It seems like compared to previous quarters, you're focusing more on your 3 commercial launches and relatively less on the R&D pipeline. Is there any particular reason for that shift in focus? And how much more work do you plan to do to optimize your R&D portfolio?

感謝您提供此更新。與前幾季相比，您似乎更專注於 3 項商業發布，而相對較少關注研發管道。這種焦點轉移有什麼特殊原因嗎？您還計劃做多少工作來優化您的研發組合？

I'll start. I mean I think we have first 4 data readouts coming in midyear. So I think we felt we'd have more data when we make sense to bring back the R&D when we've got more data. I would say actually, from a prioritization point of view, and Priya, you can weigh in here, but I think we've largely done the job of having projects that are either projects of conviction or projects where we're awaiting the data outcome. They're in flight. And just given the nature of neuroscience projects, we need to wait and see what the data say.

我開始吧。我的意思是，我認為我們將在年中公佈前 4 個數據。因此，我認為，當我們獲得更多數據時，我們認為當我們有必要重新進行研發時，我們就會獲得更多數據。我想說的是，實際上，從優先級的角度來看，Priya，你可以在這裡權衡，但我認為我們基本上已經完成了項目的工作，這些項目要么是堅定的項目，要么是我們正在等待數據結果的項目。他們在飛行中。鑑於神經科學計畫的性質，我們需要等待，看看數據會說明什麼。

I think you're going to find us much more disciplined about whether we progress or not. Our go/no-go decisions, I think, have all been clearly defined for those. I think the next job is really now to build out the pipeline, as I talked about earlier, that we want to diversify our business a little bit more than we have in the past. So Priya is certainly working along with Jane on thinking about what things we can additionally bring into the pipeline from outside. But, Priya, I don't know you want to add anything there?

我想你會發現我們對於進步與否更自律。我認為，我們的繼續/不繼續決定都已針對這些問題進行了明確定義。我認為現在的下一個工作實際上是建立管道，正如我之前談到的，我們希望比過去更加多元化我們的業務。因此，Priya 肯定正在與 Jane 一起思考我們還可以從外部將哪些東西帶入管道中。但是，Priya，我不知道你想在那裡添加什麼嗎？

Thanks, Chris. I think you covered it. That's exactly right. We are very excited about our 4 readouts. We are preparing for them. We have already worked through go/no-go criteria.

謝謝，克里斯。我認為你涵蓋了它。完全正確。我們對 4 個讀數感到非常興奮。我們正在為他們做準備。我們已經制定了通過/不通過的標準。

And we continue to remain very excited about the rest of the pipeline that's in mid and late stage, particularly our anti-Tau ASO with AD, as well as our 2 Phase III programs in SLE, litifilimab as well as dapi that we just talked about, and with litifilimab also in cutaneous lupus. So we have a number of projects in early phase development, and we're trying to be very disciplined about making sure that we make evidence and data-based decisions.

我們仍然對處於中後期階段的其餘產品感到非常興奮，特別是我們的 AD 抗 Tau ASO，以及我們剛才談到的 SLE、litifilimab 和 dapi 的 2 個 III 期項目，並且與 litifilimab 一起治療皮膚狼瘡。因此，我們有許多專案處於早期開發階段，我們正在努力非常嚴格地確保我們做出基於證據和數據的決策。

We'll go next to Chris Raymond with Piper Sandler.

接下來我們將和派珀·桑德勒一起去克里斯·雷蒙德。

Just maybe a strategic question on your biz dev strategy. So Chris, I heard your comments around diversifying away from neurology. You guys have been saying that for a while, and your deals have focused in areas other than MS. But there is actually, if you look across the industry, some decent early innovation in MS. And even with your business on the decline, our checks still indicate that Biogen remains a trusted company and there's an awful lot of value, I would argue, with that market presence.

也許只是關於您的業務開發策略的策略問題。克里斯，我聽到了你關於遠離神經病學的多元化的評論。你們這樣說已經有一段時間了，你們的交易主要集中在微軟以外的領域。但實際上，如果你縱觀整個產業，微軟領域確實存在一些不錯的早期創新。即使您的業務正在下滑，我們的檢查仍然表明百健（Biogen）仍然是一家值得信賴的公司，並且我認為該市場存在具有巨大的價值。

I guess maybe just the question here strategically, is your activities in business development, is that due to your view of the need to diversify away from MS strategically? Or is it a view that you just haven't seen an early asset worth licensing? Or is there some other underlying dynamic of the MS market that have led you guys to prioritize other areas?

我想也許這只是策略性的問題，您在業務開發方面的活動是否是由於您認為需要策略性地擺脫微軟而實現多元化？或者您只是沒有看到值得授權的早期資產？或者 MS 市場是否存在其他一些潛在的動態，導致你們優先考慮其他領域？

Well, there's a little bit of -- a lot of the above in there. I think the first is we haven't abandoned MS. We do have programs in research early. The unmet need in MS has really narrowed, it's really the progressive form, which is a very tough indication really to go after. But we have programs still in ALS. And in fact, I think the fact that QALSODY was approved has actually proven to be an enormous scientific achievement. It may not be a major financial achievement, but this really opens up the field to having a biomarker where you can tell whether something is working or not in ALS.

嗯，上面有一點點——很多。我認為第一是我們沒有放棄微軟。我們確實有早期的研究計劃。 MS 中未滿足的需求確實已經縮小，這實際上是漸進的形式，這是一個非常難以追求的指標。但我們的專案仍處於 ALS 階段。事實上，我認為 QALSODY 獲得批准這一事實實際上已被證明是一項巨大的科學成就。這可能不是一項重大的財務成就，但這確實為生物標記開闢了新的領域，您可以透過該生物標記來判斷某些藥物是否對 ALS 有效。

And so we have a number of programs in ALS. We're in Huntington's. We have a program in Parkinson's, as you know. We've got [Tau] which I think, between Tau and lupus, we see as programs of high conviction within the company.

所以我們有很多 ALS 項目。我們在亨廷頓。如您所知，我們有一個針對帕金森氏症的計畫。我們有 [Tau]，我認為，在 Tau 和狼瘡之間，我們將其視為公司內部具有高度信念的計劃。

So we feel that -- I think you're right, we are very well placed. In neurology, I wouldn't just say MS, but neurology. But the reality is, is that we sit there with programs that are very difficult to predict, very expensive, very long running. And when you actually look at the ability to do external deals, that field is also very narrow. There's just not that many people working in the CNS space.

所以我們覺得——我認為你是對的，我們處於非常有利的位置。在神經病學中，我不只是說MS，而是神經病學。但現實是，我們坐在那裡的程式非常難以預測、非常昂貴、運行時間非常長。當你真正審視進行外部交易的能力時，你會發現這個領域也非常狹窄。在中樞神經系統領域工作的人並不多。

So we're by no means abandoning it. And in fact, the fact that we go after these really tough diseases is really a source of pride within Biogen. And I have to say I continue to be amazed at the capability and talent we have within the organization.

所以我們絕不會放棄它。事實上，我們對這些非常棘手的疾病的研究確實是百健（Biogen）公司的驕傲。我必須說，我仍然對我們組織內的能力和人才感到驚訝。

But the reality is we need to have more predictable results out of R&D. And I think we do have a lot of that capability within the company. I don't see us ever moving -- going left-turn into oncology or something like that. But I do think we have a legitimacy in being in rare diseases, and expanding in immunology. In fact, I think that what we've been doing in MS and, in fact, lupus, is really an indicator of that. So I think we're going to continue to branch out. But it also branches out our opportunity set for collaboration and not just diversifying our portfolio.

但現實是我們需要從研發中獲得更可預測的結果。我認為我們公司內部確實擁有很多這樣的能力。我不認為我們會移動——左轉進入腫瘤學或類似的領域。但我確實認為我們在罕見疾病領域和免疫學領域的擴張是合法的。事實上，我認為我們在多發性硬化症和狼瘡方面所做的工作確實表明了這一點。所以我認為我們將繼續拓展業務。但它也拓展了我們的合作機會，而不僅僅是使我們的產品組合多樣化。

Thanks, Chris. And can we take our last question please, operator?

謝謝，克里斯。接線員，我們可以回答最後一個問題嗎？

Yes. We'll go next to Terence Flynn with Morgan Stanley.

是的。接下來我們將與摩根士丹利一起討論特倫斯·弗林。

Great. Maybe 2 part on LEQEMBI. Just wondering, obviously, you talked about the number of unique prescribers more than doubling this quarter, just wondering how much more breadth you're expecting from the field force expansion here as we think about the forward through '24. And then any early insights on duration of treatment that you're seeing so far?

偉大的。也許有 2 部分是關於 LEQEMBI 的。只是想知道，顯然，您談到本季度獨特處方者的數量增加了一倍以上，只是想知道，當我們考慮到 24 年的前景時，您對這裡的現場部隊擴張的期望有多大。那麼到目前為止，您對治療持續時間有什麼早期見解嗎？

Yes. So thank you for the question. My outlook for the rest of the year is when you really think about the phases that these IDNs are in. And even you see these small accounts, they do move fast, right, out in the community.

是的。謝謝你的提問。我對今年剩餘時間的展望是，當你真正思考這些 IDN 所處的階段時。

And if you really take a step back and look in context for the IDNs, we got an approval -- full approval in July. It took about 6 to 8 months for these very large systems to get organized, which is that staged and phased approach I talked about. And the fact that now they are actually opening up these other sites for diagnosing and prescribing, I believe that you're going to also see the number of physicians prescribing increasing, and it will continue to increase throughout the rest of the year. If you look at how many physicians that we are targeting and the numbers that are actually prescribing, we still have a good delta there.

如果您真的退後一步並查看 IDN 的上下文，我們會在 7 月獲得批准——完全批准。這些非常大的系統大約需要6到8個月的時間才能組織起來，這就是我談到的分階段和階段的方法。事實上，現在他們實際上開放了這些其他網站進行診斷和開處方，我相信您也會看到開處方的醫生數量增加，並且在今年剩餘時間內將繼續增加。如果你看看我們的目標醫生數量以及實際開出處方的醫生數量，我們仍然有一個很好的增量。

And so I do see that continuing, especially with the field force coming in, if they're covering our goal, is really to drive the acceleration of these large IDNs. I talked to you about the priority 100. But keep in mind, we actually target quite more than that. I just keep referring to the priority. And there are many other IDNs that are also prescribing and are also expanding and extending.

因此，我確實看到，如果他們能夠實現我們的目標，那麼繼續下去，尤其是在現場人員介入的情況下，確實會推動這些大型 IDN 的加速發展。我與您討論了優先順序 100。我只是一直提到優先順序。還有許多其他 IDN 也在規定並且也在擴展和延伸。

The second part of your question was around -- duration. You know what's interesting with this, and there's been a lot of conversations with many of these prescribing sites, physicians lay very specific and explicit expectations with patients that, when they go on this therapy, their expectation is they come in every 2 weeks to get their IV infusion and that they stay on product. And what we've seen thus far and what we believe to be happening thus far is patients are staying on product. We hear that as feedback from the physicians. We also hear that as feedback from the numbers that we see, the data that we see.

你問題的第二部分是關於──持續時間。你知道這有什麼有趣的地方，並且與許多這樣的處方網站進行了很多對話，醫生對患者提出了非常具體和明確的期望，當他們接受這種治療時，他們的期望是他們每兩週來一次他們的靜脈注射並繼續使用產品。到目前為止，我們所看到的以及我們相信迄今為止正在發生的情況是，患者仍在繼續使用該產品。我們聽到這是醫生的回饋。我們也聽到了來自我們看到的數字和數據的回饋。

So far with duration, the plan is that they're keeping patients on product. I think there are questions out there as to what to do about duration, but in the absence of any data, physicians are keeping patients on.

到目前為止，他們的計劃是讓患者繼續使用該產品。我認為對於如何延長持續時間存在疑問，但在缺乏任何數據的情況下，醫生會繼續讓患者繼續治療。

Right. Thanks, Alisha, and thanks to all of you for joining us today for the call. And the IR team, of course, is available for follow-ups. Have a good rest of your day.

正確的。謝謝艾莉莎，也謝謝大家今天參加我們的電話會議。當然，IR 團隊也可以進行後續跟進。祝你這一天好好休息。

This does conclude today's conference. We thank you for your participation.

今天的會議到此結束。我們感謝您的參與。