(BIIB) 2023 Q1 法說會逐字稿

Good morning. My name is Bettina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen First Quarter 2023 Earnings Call and Business Update. (Operator Instructions) Today's conference is being recorded. Thank you.

早上好。我叫貝蒂娜，今天我將擔任你們的會議接線員。此時，我想歡迎大家參加 Biogen 2023 年第一季度收益電話會議和業務更新。 （操作員說明）正在錄製今天的會議。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.

我現在想將會議轉交給投資者關係主管 Chuck Triano 先生。 Triano 先生，您可以開始您的會議了。

Thank you, Bettina. Good morning, and welcome to Biogen's First Quarter 2023 Earnings Call. Before we begin, I encourage everyone to go to the Investors section of biogen.com to find the earnings release and related financial tables, including our GAAP financial measures and a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today on the call. 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 non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We've also posted slides on our website that follow the discussion related to this call.

謝謝你，貝蒂娜。早上好，歡迎來到 Biogen 的 2023 年第一季度收益電話會議。在我們開始之前，我鼓勵大家去 biogen.com 的投資者部分找到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 與非 GAAP 財務指標的調節電話。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 財務結果的對賬。我們相信，非 GAAP 財務業績更好地代表了我們業務的持續經濟狀況，並反映了我們如何在內部管理業務。我們還在我們的網站上發布了幻燈片，跟進與本次電話會議相關的討論。

I'd like to point out that we will be making forward-looking statements which are based on our current 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，我們將根據我們目前的預期做出前瞻性陳述。這些陳述受某些風險和不確定因素的影響，我們的實際結果可能存在重大差異。我鼓勵您查閱我們在 SEC 文件中討論的風險因素以獲取更多詳細信息。

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; and our CFO, Mike McDonnell. Chris, Priya and Mike will each make opening comments, and then we'll move to the Q&A session. (Operator Instructions)

在今天的電話會議上，我們的總裁兼首席執行官 Chris Viehbacher 也加入了我的行列；開發主管 Priya Singhal 博士；以及我們的首席財務官 Mike McDonnell。 Chris、Priya 和 Mike 將分別發表開場白，然後我們將進入問答環節。 （操作員說明）

I'll now turn the call over to Chris.

我現在將電話轉給克里斯。

Thank you, Chuck. Good morning, everybody. I'll start by first welcoming Chuck Triano as our new Head of Investor Relations. Good to have you on the team, Chuck.

謝謝你，查克。大家早上好。首先，我首先歡迎查克·特里亞諾 (Chuck Triano) 擔任我們的新投資者關係主管。很高興你加入團隊，Chuck。

On our last call, we described 5 priorities for the business that you see on the first slide here. And during the first quarter, I think we made a lot of good progress against those 5 priorities. We are continuing to work toward the potential launches of LEQEMBI in Alzheimer's disease and zuranolone in both MDD and PPD. And I'm going to cover that in the next slide because that's really, in some ways, a super priority.

在上次通話中，我們描述了您在此處第一張幻燈片中看到的 5 個業務優先級。在第一季度，我認為我們在這 5 個優先事項方面取得了很大進展。我們正在繼續努力，爭取在阿爾茨海默病中推出 LEQEMBI，在 MDD 和 PPD 中推出 zuranolone。我將在下一張幻燈片中介紹這一點，因為在某些方面，這確實是一個超級優先事項。

On the next point on improving the risk profile and productivity of R&D, Priya will review the steps taken to improve the risk profile and the productivity of R&D, and you'll see that in greater detail.

關於提高研發風險狀況和生產力的下一點，Priya 將回顧為改善風險狀況和研發生產力而採取的步驟，您會看到更詳細的信息。

So I'm going to cover a little bit more on the cost base. The first thing I'd like to say is that we've made good progress on the previous program that it amounts $1 billion of cost savings. That -- those $1 billion have been secured and have been -- that program is complete.

因此，我將更多地介紹成本基礎。我想說的第一件事是，我們在之前的計劃中取得了良好的進展，節省了 10 億美元的成本。那 - 這 10 億美元已經得到保障並且已經 - 該計劃已經完成。

But over the last several months, we've been getting a better understanding of how the company operates, working with our senior leaders and thinking about how we operate at all levels of the company, particularly at a global, regional and affiliate level. And as we said before, we do have a higher cost base than the average company in our category.

但在過去的幾個月裡，我們一直在更好地了解公司的運作方式，與我們的高級領導一起工作，並思考我們如何在公司的各個層面運作，特別是在全球、區域和附屬機構層面。正如我們之前所說，我們的成本基礎確實高於同類公司的平均水平。

And so we've initiated an additional program to align our operations and cost base with the expected revenue while leaving enough money for the upcoming launches. And we internally refer to this program as Fit for Growth. And really, what we're trying to do is balance the opportunity for profitable growth by investing in our product launches and the R&D projects that we deem priority, with an attempt to try to reduce that cost base and get that back to something that looks a little bit more in line with our competitors.

因此，我們啟動了一項額外的計劃，使我們的運營和成本基礎與預期收入保持一致，同時為即將推出的產品留出足夠的資金。我們在內部將此計劃稱為 Fit for Growth。事實上，我們正在努力做的是通過投資於我們認為優先的產品發布和研發項目來平衡盈利增長的機會，並試圖降低成本基礎並將其恢復到看起來像更符合我們的競爭對手。

Now that's not just a simple job of taking out cost. What we're really trying to do is redesign the company. We have these 2 launches. They're going to have different geographic points of focus at the start. We won't have zuranolone for a few years outside of the U.S. Zuranolone is clearly a top priority in the short-term in the U.S. And outside the U.S., we're going to be certainly focused on the LEQEMBI launch in the first instance.

現在，這不僅僅是一項簡單的成本計算工作。我們真正想做的是重新設計公司。我們有這兩個發布。一開始他們將有不同的地理焦點。我們在美國以外的幾年內不會有 zuranolone。Zuranolone 顯然是美國短期內的首要任務。在美國以外，我們肯定會首先關注 LEQEMBI 的推出。

So one of the things we want to do is make sure that we don't lose what is good in the company and what has been working. We also have to remember that we are still a leader in multiple sclerosis. There are a lot of patients who depend upon our products, and we have to make sure that the physicians who treat those patients have adequate information. So there's a balancing act as we try to shift our resources behind the growth opportunities while still supporting our historic MS business.

因此，我們要做的其中一件事就是確保我們不會失去公司的優點和一直有效的東西。我們還必須記住，我們仍然是多發性硬化症領域的領導者。有很多患者依賴我們的產品，我們必須確保治療這些患者的醫生有足夠的信息。因此，在我們試圖將資源轉移到增長機會背後，同時仍然支持我們歷史悠久的 MS 業務時，存在一種平衡行為。

And so we're taking essentially a bottoms-up and a methodical approach to this. This could have a much different approach to our operating model. We've been 45 years in multiple sclerosis with a limited product profile. Yes, we had, at one point, some products in hemophilia. And obviously, we have SPINRAZA. And as a result, we had an awful lot of centralized cost.

因此，我們基本上採取了自下而上和有條理的方法來解決這個問題。這可能對我們的運營模式有很大不同的方法。我們在多發性硬化症領域已有 45 年曆史，產品概況有限。是的，我們曾經有過一些治療血友病的產品。顯然，我們有 SPINRAZA。結果，我們有大量的集中成本。

Right now, we're looking at how do we get a lot more of our resource and our attention closer to the customer. So it's a redesign effort, and it's meant to be durable. So we do recognize that there's an opportunity to reduce cost, but we really are looking at something more transformational that really sets the company up for growth. We'll be able to say more about that in Q2.

現在，我們正在研究如何獲得更多的資源和更貼近客戶的注意力。所以這是一項重新設計的工作，它意味著耐用。因此，我們確實認識到存在降低成本的機會，但我們確實在尋找更具變革性的東西，真正為公司的增長做好準備。我們將能夠在第二季度對此進行更多討論。

Then another priority is really managing the base business. There's 2 dynamics in the company. We are a leader in MS, but that business is increasingly affected by competition. And we have growth opportunities with LEQEMBI and zuranolone.

然後另一個優先事項是真正管理基礎業務。公司有2個動態。我們是 MS 領域的領導者，但該業務越來越受到競爭的影響。我們有 LEQEMBI 和 zuranolone 的增長機會。

So on the base business, the idea is how do we manage that business as profitably as we can. We did receive a favorable decision from the Court of Justice of the European Union related to TECFIDERA regulatory data and marketing protection, which was an important reinforcement of intellectual property and exclusivity rights. We believe this provides us marketing protection until at least February of next year, and we are looking to enforce that protection, but it will take a little time for the market to settle. And separately, we also continue to enforce our 2028 patent for TECFIDERA in the EU.

所以在基礎業務上，我們的想法是我們如何盡可能盈利地管理該業務。我們確實收到了歐盟法院關於 TECFIDERA 監管數據和營銷保護的有利決定，這是對知識產權和專有權的重要加強。我們相信這至少會在明年 2 月之前為我們提供營銷保護，我們正在尋求實施這種保護，但市場需要一點時間才能穩定下來。另外，我們還繼續在歐盟執行 TECFIDERA 的 2028 年專利。

We're also looking to aim to -- we're looking to maximize the profitability of the MS franchise. Up until now, the goal has been to defend revenue at all costs. I think now we want to take a little bit more of a nuanced approach of looking at where are the opportunities in MS, where do we have intellectual property, where do we have still sales promotion sensitivity and try to align our resources with that and perhaps look at other means of promoting products that are a little less expensive.

我們也在尋求目標——我們希望最大限度地提高 MS 特許經營權的盈利能力。到目前為止，目標一直是不惜一切代價保衛收入。我想現在我們想採取更細緻的方法來研究 MS 的機會在哪裡，我們在哪裡擁有知識產權，我們在哪裡仍然對促銷敏感，並嘗試將我們的資源與此相結合，也許查看其他促銷價格較低的產品的方法。

We do believe that SPINRAZA can return to growth, and we are seeing stabilization out there in the marketplace. Gene therapy is not for everyone, and the oral therapy has its limits. And there are still quite a few patients that suffer from SMA that don't benefit from any treatment.

我們確實相信 SPINRAZA 可以恢復增長，我們看到市場穩定下來。基因療法並不適合所有人，口服療法也有其局限性。並且仍然有相當多的患有 SMA 的患者無法從任何治療中獲益。

And as we announced at the previous quarter, we do have a formal process underway to evaluate strategic options for our biosimilars business. This is a very good business, and I think especially with the launch of biosimilars for HUMIRA, we are seeing an opportunity for the health care system to make important economies that help fund innovation. And we need to think about who is -- and how is the best way to manage this business and who might be the best owner of that business.

正如我們在上一季度宣布的那樣，我們確實有一個正式的流程來評估我們生物仿製藥業務的戰略選擇。這是一項非常好的業務，我認為特別是隨著 HUMIRA 生物仿製藥的推出，我們看到了醫療保健系統創造重要經濟體以資助創新的機會。我們需要考慮誰是管理該業務的最佳方式，以及誰可能是該業務的最佳所有者。

On external growth, we're looking at external growth really from 2 perspectives. One is how do we balance the company a little bit more on its pipeline? It has been very neuroscience-focused. But as I've argued in the past, I think with MS, which is basically an autoimmune disease, I think we could migrate into immunology.

關於外部增長，我們確實從兩個角度看待外部增長。一個是我們如何在公司的管道上更多地平衡公司？它一直非常關注神經科學。但正如我過去所說，我認為對於基本上是一種自身免疫性疾病的 MS，我認為我們可以轉向免疫學。

With SPINRAZA, I think we have an experience in rare diseases, and that will be reinforced with tofersen. And of course, we're in neuropsychiatry with zuranolone. So these offer opportunities to think about how do we build out some of those franchises.

有了 SPINRAZA，我認為我們在罕見病方面有經驗，而 tofersen 將加強這一點。當然，我們在使用 zuranolone 進行神經精神病學研究。因此，這些提供了思考我們如何建立其中一些特許經營權的機會。

The other is, I did describe this dynamic of the MS franchise declining slightly and new growth coming. And we may look at external growth as a way of making sure that, that transition is as smooth as possible from a results point of view. I'm pleased to say that we have appointed Adam Keeney as our Head of Corporate Development. Adam has over 20 years of experience, not just in business development, but also in R&D and strategy across both large pharma and he was the CEO of a biotech, so I think he's got some entrepreneurial spirit that will be very welcomed at Biogen.

另一個是，我確實描述了 MS 特許經營略有下降和新增長即將到來的動態。我們可以將外部增長視為確保從結果的角度來看盡可能順利過渡的一種方式。我很高興地宣布，我們已任命 Adam Keeney 為我們的企業發展主管。 Adam 擁有超過 20 年的經驗，不僅在業務開發方面，而且在大型製藥公司的研發和戰略方面，他還是一家生物技術公司的首席執行官，所以我認為他具有一定的企業家精神，這將在 Biogen 大受歡迎。

We do see LEQEMBI and zuranolone as major contributors to revenue, but we want to continue to think about business development to support the growth trajectory and diversify, as I said.

我們確實將 LEQEMBI 和 zuranolone 視為收入的主要貢獻者，但正如我所說，我們希望繼續考慮業務發展以支持增長軌跡和多元化。

So if I can have the next slide, please. So we've really got an unprecedented opportunity. We have today a PDUFA date for tofersen. We have a PDUFA date in July for LEQEMBI and a PDUFA date in August for zuranolone. I can't think of another major biopharmaceutical company that has that many new significant products to launch. That's a huge opportunity.

那麼請給我下一張幻燈片。所以我們真的有一個前所未有的機會。我們今天有 tofersen 的 PDUFA 日期。 LEQEMBI 的 PDUFA 日期為 7 月，zuranolone 的 PDUFA 日期為 8 月。我想不出還有哪家大型生物製藥公司有那麼多重要的新產品要推出。這是一個巨大的機會。

But as I said earlier, we have to think about capabilities on that. These are going to be in different areas. Obviously, LEQEMBI is a little closer to home since it's still the neurologist. But there's an awful lot of market building will have to be done there. And of course, zuranolone takes us into a much different area and a much different physician franchise.

但正如我之前所說，我們必須考慮這方面的能力。這些將在不同的領域。顯然，LEQEMBI 離家更近一些，因為它仍然是神經科醫生。但是必須在那裡完成大量的市場建設工作。當然，zuranolone 將我們帶入了一個截然不同的領域和一個截然不同的醫師專營權。

But we're making our milestones. We received accelerated approval in the U.S. back in January. We filed for traditional approval in the U.S. On the same day, within the EU, Japan and Eisai initiated regulatory filing in China. Filing all of those dossiers in that kind of timeframe is really quite significant, and I have to congratulate our colleagues at Eisai for this effort. These filings have received priority review in the U.S., Japan and China. And of course, a major milestone in that the Veteran's Health Administration has decided to reimburse LEQEMBI.

但我們正在實現我們的里程碑。早在 1 月份，我們就在美國獲得了加速批准。我們在美國申請傳統批准。同一天，在歐盟，日本和衛材在中國啟動了監管備案。在這樣的時間範圍內提交所有這些檔案真的非常重要，我必須祝賀我們在衛材的同事所做的努力。這些申請已在美國、日本和中國獲得優先審查。當然，退伍軍人健康管理局決定償還 LEQEMBI 是一個重要的里程碑。

Now LEQEMBI is going to be the first anti-amyloid antibody to receive traditional approval globally, hopefully in July. As we said, this is not a straightforward launch. It's a complex diagnosis involving PET scans, [lump or puncture] for amyloid confirmation. Specialists who are already busy MRI imaging, biweekly infusion, and we know that capacity could be an issue initially. CMS reimbursement will be the next major milestone which we expect to have an answer on once the product has received full approval, as expected, following the PDUFA date in July.

現在，LEQEMBI 將成為第一個在全球範圍內獲得傳統批准的抗澱粉樣蛋白抗體，有望在 7 月獲得批准。正如我們所說，這不是一個簡單的發布。這是一項複雜的診斷，涉及 PET 掃描、[腫塊或穿刺] 以確認澱粉樣蛋白。已經忙於 MRI 成像、每兩週一次輸液的專家，我們知道容量最初可能是一個問題。 CMS 報銷將是下一個重要的里程碑，我們希望一旦產品如預期那樣在 7 月的 PDUFA 日期之後獲得完全批准，就會得到答案。

More importantly though, we're looking at how do we right now alleviate those bottlenecks. Yes, CMS is there, but both companies are already thinking about what we can do to make this easier for patients and actually reduce cost. Eisai and Biogen are pursuing maintenance dosing and the subcu formulation. Blood-based diagnostics, as I've said in the past, are really going to be a game changer in this space. And we believe that over time, capacity is going to expand to meet the need.

但更重要的是，我們正在研究我們現在如何緩解這些瓶頸。是的，CMS 就在那裡，但兩家公司已經在考慮我們可以做些什麼來讓這對患者更容易，並實際降低成本。衛材和百健（Biogen）正在尋求維持劑量和 subcu 配方。正如我過去所說，基於血液的診斷真的會成為這個領域的遊戲規則改變者。我們相信，隨著時間的推移，容量將會擴大以滿足需求。

For reimbursement, this is a big question. The Veterans Association is certainly helpful. I would just point out that compared to the situation that ADUHELM faced, we are getting a lot more support from Congress. The American Association of Neurologists has written in support. And I know that a number of patient advocacy groups are active in ensuring that patients have access to this important therapy.

對於報銷，這是一個大問題。退伍軍人協會當然很有幫助。我只想指出，與 ADUHELM 面臨的情況相比，我們從國會獲得了更多的支持。美國神經病學家協會已寫信支持。我知道許多患者權益團體積極確保患者能夠獲得這一重要療法。

So Eisai is responsible under the contract. We're engaging with CMS. And we would hope to see broad coverage coming out of the CMS decision.

所以衛材根據合同負責。我們正在與 CMS 合作。我們希望看到 CMS 決定的廣泛覆蓋面。

Now I'd like to talk about zuranolone just for a few minutes. I mean, zuranolone is still, I think, an underestimated asset in our portfolio. Unfortunately, a lot of people suffer from depression, so it is a large market. There are clearly a number of older medicines that are available. The main problem with those are the side effects of those medicines and the length of time it takes for them to work. And zuranolone works potentially in 3 days, and it's going to be a different type of launch because we're talking about a treatment that works in 2 weeks. The only analog I can find that is anyway similar was Zithromax. So we do know that there is going to be some need for education.

現在我想花幾分鐘談談 zuranolone。我的意思是，我認為 zuranolone 仍然是我們投資組合中被低估的資產。不幸的是，很多人都患有抑鬱症，所以這是一個很大的市場。顯然有許多可用的舊藥。這些的主要問題是這些藥物的副作用和它們起作用所需的時間長度。 zuranolone 可能會在 3 天內起效，這將是一種不同類型的上市，因為我們談論的是一種在 2 週內起效的治療方法。我能找到的唯一相似的類似物是 Zithromax。所以我們確實知道會有一些教育需求。

Physicians are used to treating on a chronic basis. As we launch it, and we're going to have to think about different metrics, one of the things in the launch that you look for is when do NRxs switch to TRxs? Well, we're not going to see that. There are not going to be TRxs with the product.

醫生習慣於長期治療。當我們發布它時，我們將不得不考慮不同的指標，您在發布中尋找的一件事是 NRxs 何時切換到 TRxs？好吧，我們不會看到那個。產品不會有 TRx。

So I think there are these changes in physician behavior. This is a paradigm shift. And paradigm shift is not always a good thing in pharmaceutical marketing, as you know.

所以我認為醫生的行為發生了這些變化。這是一種範式轉變。如您所知，範式轉變在醫藥營銷中並不總是一件好事。

However, what really drives us, this is a product that really makes a difference for patients. This is a product that will -- is efficacious, it works fast. And think about the freedom of knowing that after 2 weeks that you can stop taking zuranolone. So I think that is going to be an enormous opportunity. And I'll just finish with tofersen on this. It is not a big product, obviously, about 300 patients, but it's classic Biogen. There's a -- we have a long history in ALS, a lot of setbacks, but the organization has an ability to learn and adapt, and Biogen was able to partner with the scientific community to help characterize neurofilament as a biomarker in neuromuscular disorders. This is a huge deal because neurofilament will be relevant to a lot of researchers who are looking at ALS.

然而，真正推動我們的是，這是一款真正為患者帶來改變的產品。這是一種有效的產品，它見效快。想想知道 2 週後您可以停止服用 zuranolone 的自由。所以我認為這將是一個巨大的機會。我將就此與 tofersen 結束。它不是一個大產品，顯然，大約 300 名患者，但它是經典的百健（Biogen）產品。有一個 - 我們在 ALS 方面有著悠久的歷史，有很多挫折，但該組織具有學習和適應的能力，Biogen 能夠與科學界合作，幫助將神經絲表徵為神經肌肉疾病的生物標誌物。這是一件大事，因為神經絲將與許多研究 ALS 的研究人員相關。

So I think we've got some groundbreaking science here. And this is where Biogen has had the resilience to go after a lot of significant unmet need that -- and has resolved things in a way that not everybody has been able to do.

所以我認為我們這裡有一些突破性的科學。這就是百健（Biogen）在許多未滿足的重大需求之後有彈性去解決的地方——並且以一種並非每個人都能做到的方式解決了問題。

Next slide, if I could. We've got a number of milestones coming, as you can see here on the slide. By our Q2 call, we would expect to be in a different place with LEQEMBI. We should hopefully have the PDUFA date behind us successfully. Hopefully, we've received a traditional approval and broader CMS coverage in the U.S. And of course, we'll be communicating more about our Fit for Growth cost optimization program.

下一張幻燈片，如果可以的話。正如您在幻燈片上看到的那樣，我們即將迎來許多里程碑。通過我們的第二季度電話會議，我們希望 LEQEMBI 處於不同的位置。我們應該希望 PDUFA 日期能夠成功地落在我們身後。希望我們在美國獲得了傳統的批准和更廣泛的 CMS 覆蓋範圍。當然，我們將就我們的 Fit for Growth 成本優化計劃進行更多交流。

By the end of this year, hopefully, we've got the first U.S. approval of LEQEMBI in Japan. And hopefully, we'll have received the approval for zuranolone in both MDD and PPD as well as having completed a 3-month DEA scheduling period and initiated the launch.

希望到今年年底，我們能在日本獲得美國對 LEQEMBI 的首個批准。希望我們將在 MDD 和 PPD 中獲得 zuranolone 的批准，並完成 3 個月的 DEA 調度期並啟動發布。

And if I look further ahead, by the end of -- by this time next year, I think we have an opportunity to build the global footprint of LEQEMBI with approvals in Europe and China. And of course, we'll take the next steps on evolving the treatment paradigm in Alzheimer's disease with an expected regulatory filing of LEQEMBI maintenance dosing. We would also expect regulatory filings for subcutaneous dosing which could facilitate at-home administration.

如果我展望未來，到年底——到明年這個時候，我認為我們有機會在歐洲和中國獲得批准，建立 LEQEMBI 的全球足跡。當然，我們將採取下一步行動，通過預期的 LEQEMBI 維持劑量監管備案，發展阿爾茨海默病的治療模式。我們還希望提交皮下給藥的監管文件，這可以促進家庭管理。

So in conclusion, through a combination of groundbreaking science, high potential near-term commercial opportunities and diligent capital allocation, I think Biogen is going to be well-positioned for the sustainable long-term growth. I'd like to now turn it over to Priya for an update on our progress in R&D.

因此，總而言之，通過結合突破性的科學、高潛力的近期商業機會和勤奮的資本配置，我認為百健（Biogen）將為可持續的長期增長做好準備。我現在想把它轉交給 Priya，了解我們在研發方面的最新進展。

Thank you, Chris. Last quarter, we made important progress advancing key pipeline programs. As Chris just pointed out, we now have the opportunity to deliver 3 potential new drug launches across 4 indications this year, all in areas of high unmet need, including Alzheimer's disease, major depressive disorder, postpartum depression and SOD1-ALS.

謝謝你，克里斯。上個季度，我們在推進關鍵管道項目方面取得了重要進展。正如 Chris 剛才指出的那樣，我們現在有機會在今年推出 3 種潛在的新藥，涵蓋 4 個適應症，所有這些都在高度未滿足的需求領域，包括阿爾茨海默病、重度抑鬱症、產後抑鬱症和 SOD1-ALS。

We also continue to evaluate potential opportunities for geographic and indication expansion for zuranolone as we work with our collaborator Sage to prepare for a potential U.S. launch later this year.

在與我們的合作夥伴 Sage 合作為今年晚些時候在美國上市做準備時，我們還繼續評估祖蘭諾酮的地理和適應症擴展的潛在機會。

I will share key highlights from the quarter across broader efforts in Alzheimer's disease with tofersen program in SOD1-ALS and the progress that we are making to rebalance the risk profile and improve productivity of the R&D pipeline.

我將分享本季度通過 SOD1-ALS 中的 tofersen 計劃在阿爾茨海默氏病方面更廣泛努力的主要亮點，以及我們在重新平衡風險狀況和提高研發渠道生產力方面取得的進展。

I will now share highlights of additional analyses Eisai recently presented or published, consistent with both companies' commitment to transparency. First, regarding activities of daily living, new analysis of ADCS-MCI-ADL presented at ADPD last month showed that all individual items of this scale favored LEQEMBI at 18 months as compared to placebo. This includes items like ability to make a (inaudible) or keeping appointment. This result also made our CLARITY AD study outcome on the CDR Sum of Boxes where LEQEMBI treatment [slowed] decline across all 6 individual domains at 18 months versus placebo.

我現在將分享衛材最近提交或發表的其他分析的要點，這與兩家公司對透明度的承諾一致。首先，關於日常生活活動，上個月在 ADPD 上提出的 ADCS-MCI-ADL 的新分析表明，與安慰劑相比，該量表的所有單個項目在 18 個月時都支持 LEQEMBI。這包括諸如進行（聽不清）或保持約會的能力之類的項目。這一結果也使我們的 CLARITY AD 研究結果在 CDR 框總和上取得，其中 LEQEMBI 治療[減緩]在 18 個月時與安慰劑相比在所有 6 個單獨領域下降。

Additionally, results from CLARITY AD showed that at 18 months, LEQEMBI treatment resulted in a 50% less decline from baseline on scales designed to assess quality of life and reduced care partner burden as compared to placebo.

此外，CLARITY AD 的結果顯示，在 18 個月時，與安慰劑相比，LEQEMBI 治療導致旨在評估生活質量和減輕護理夥伴負擔的量表較基線下降 50%。

In addition was also presented an updated analysis of ARIA from the CLARITY AD study to evaluate ARIA incidents in LEQEMBI-treated participants on antiplatelet or anticoagulant drugs as compared to LEQEMBI-treated participants that were not on either. The results were encouraging and showed that ARIA incidents were similar in the 2 groups.

此外，還提供了來自 CLARITY AD 研究的 ARIA 更新分析，以評估 LEQEMBI 治療的參與者服用抗血小板或抗凝藥物的 ARIA 事件與 LEQEMBI 治療的參與者（兩者均未服用）相比。結果令人鼓舞，表明 ARIA 事件在兩組中相似。

In addition to the data presented at ADPD, newly published analyses from LEQEMBI Phase II study reinforce the finding that while [plaques] level begin to return slowly after treatment discontinuation, other biomarkers of AD biology such as plasma A-beta [42 to 40] ratio reaccumulate quickly. We believe these findings further support the potential benefit of continued treatment with LEQEMBI after plaques have been removed.

除了在 ADPD 上提供的數據外，LEQEMBI II 期研究新發表的分析進一步證實了這一發現，即雖然 [斑塊] 水平在治療停止後開始緩慢恢復，但 AD 生物學的其他生物標誌物如血漿 A-β [42 至 40]比率迅速重新積累。我們相信這些發現進一步支持在去除斑塊後繼續使用 LEQEMBI 治療的潛在益處。

Building on their prior work, Eisai published a new analysis of the long-term health outcomes associated with LEQEMBI treatment. Updated analysis incorporated data from the Phase III CLARITY AD study, replacing the prior modeling that used Phase IIb study results. The analysis of the Phase III data, consistent with the analysis of the prior Phase IIb study results, showed that LEQEMBI resulted in a delay of approximately 2 to 3 years in meantime to progression to mild, moderate and severe AD dementia versus standard of care alone. We believe these results build upon and reinforce the significant body of evidence that has been generated on LEQEMBI.

基於他們之前的工作，衛材發表了一份關於 LEQEMBI 治療相關長期健康結果的新分析。更新後的分析納入了來自 III 期 CLARITY AD 研究的數據，取代了之前使用 IIb 期研究結果的模型。 III 期數據分析與先前 IIb 期研究結果的分析一致，表明與單獨使用標準護理相比，LEQEMBI 導致進展為輕度、中度和重度 AD 癡呆的時間延遲了大約 2 至 3 年.我們相信這些結果建立在並加強了 LEQEMBI 上產生的大量證據之上。

Biogen is committed to building on its deep expertise and experience in Alzheimer's disease by advancing an industry-leading Alzheimer's pipeline that is diversified across therapeutic modalities and molecular targets. This includes focusing on tau. Intracellular neurofibrillary tangle, which represent a pathological hallmark of Alzheimer's, are composed of [hypophosphorylated] tau protein.

百健（Biogen）致力於通過推進行業領先的阿爾茨海默氏症管道，在治療方式和分子靶點上實現多樣化，以鞏固其在阿爾茨海默氏症方面的深厚專業知識和經驗。這包括關注 tau。細胞內神經原纖維纏結是阿爾茨海默病的病理標誌，由 [低磷酸化] tau 蛋白組成。

Unlike amyloid plaques, which are observed to build up in the brain years before the onset of cognitive symptoms, tau tangles are more closely related to the neuronal cell loss and onset of clinical symptoms. To address tau pathology, we are advancing BIIB080, an antisense oligonucleotide targeting tau mRNA aiming to reduce all forms of tau protein. Importantly, this is a very different approach than utilizing a tau-directed antibody which is hypothesized to target only extracellular tau.

與觀察到認知症狀出現前數年在大腦中形成的澱粉樣斑塊不同，tau 蛋白纏結與神經元細胞丟失和臨床症狀發作更密切相關。為了解決 tau 病理學問題，我們正在推進 BIIB080，這是一種針對 tau mRNA 的反義寡核苷酸，旨在減少所有形式的 tau 蛋白。重要的是，這是一種與利用 tau 定向抗體截然不同的方法，後者被假設僅靶向細胞外 tau。

We were encouraged by the early results of this ASO-based approach as evidenced by the BIIB080 Phase Ib data in Alzheimer's disease which were presented last month at ADPD and also published in Nature Medicine, which went live online yesterday.

我們對這種基於 ASO 的方法的早期結果感到鼓舞，阿爾茨海默病的 BIIB080 Ib 期數據證明了這一點，該數據於上個月在 ADPD 上發表，並發表在昨天上線的《自然醫學》上。

Phase Ib data shown here on the slide. BIIB080 was generally well-tolerated. Majority of adverse events were mild or moderate in severity, of which the most common were headache, back pain and post-lumbar puncture syndrome. We observed a time and dose-dependent reduction in CSF total and phospho-tau across the multiple ascending dose and long-term extension periods. Total tau continued to decline 16 weeks following the last dose in the MAD portion of the study, both in the high dose Q4 weekly and the Q12 weekly. And we saw a 50% reduction from baselines.

幻燈片上顯示的 Ib 期數據。 BIIB080 一般耐受性良好。大多數不良事件的嚴重程度為輕度或中度，其中最常見的是頭痛、背痛和腰椎穿刺後綜合徵。我們觀察到在多次遞增劑量和長期延長期間 CSF 總量和磷酸化 tau 的時間和劑量依賴性減少。在研究的 MAD 部分中，在每周高劑量 Q4 和每週 Q12 中，總 tau 在最後一次給藥後 16 周繼續下降。我們看到與基線相比減少了 50%。

We observed that effect on neurofibrillary tangle, as visualized, via tau PET as early as 25 weeks across all brain regions assessed. Reduction in tau burden in all treatment groups at the end of the open-label extension at 100 weeks.

早在 25 週時，我們就在所有評估的大腦區域中通過 tau PET 觀察到了對神經原纖維纏結的影響，如圖所示。在 100 週的開放標籤擴展結束時，所有治療組的 tau 負荷均有所降低。

The BIIB080 study is the first to demonstrate this magnitude of tau PET reduction across brain regions. Encouraged by these early results, we continue to enroll the Phase II CELIA study of BIIB080 in early Alzheimer's disease, where we are exploring different dosing regimens, including every 12 weeks and every 24-week dosing.

BIIB080 研究首次證明了 tau PET 在整個大腦區域的減少程度。受到這些早期結果的鼓舞，我們繼續參加 BIIB080 在早期阿爾茨海默病中的 II 期 CELIA 研究，我們正在探索不同的給藥方案，包括每 12 周和每 24 週給藥一次。

Last month, an advisory committee by the FDA met to review the tofersen data in SOD1-ALS. The advisory committee unanimously agreed that reduction in plasma neurofilament light is reasonably likely to predict clinical benefit of tofersen for the treatment of SOD1-ALS. And they also reached a consensus that the benefit-risk profile was favorable.

上個月，FDA 的一個諮詢委員會開會審查了 SOD1-ALS 中的 tofersen 數據。諮詢委員會一致同意，血漿神經絲光的減少很可能預測托弗森治療 SOD1-ALS 的臨床益處。他們還達成共識，認為收益-風險狀況是有利的。

As Chris mentioned, Biogen has spent years collaborating with the scientific community to characterize neurofilament as a marker of axonal injury and neurodegeneration, and we view the outcome of the advisory committee as a significant advancement for the field.

正如 Chris 提到的，百健（Biogen）多年來一直與科學界合作，將神經絲定性為軸突損傷和神經變性的標誌物，我們認為諮詢委員會的成果是該領域的重大進步。

We believe these developments also inform our other programs in ALS, including BIIB105, an antisense oligonucleotide targeting ataxin-2 which may have therapeutic potential in the broader ALS population. BIB105 aims to reduce ataxin-2 protein levels, which we hypothesized will reduce toxic TDP-43 clusters that are observed in nearly all people living with ALS.

我們相信這些發展也為我們在 ALS 中的其他項目提供了信息，包括 BIIB105，一種靶向 ataxin-2 的反義寡核苷酸，可能在更廣泛的 ALS 人群中具有治療潛力。 BIB105 旨在降低 ataxin-2 蛋白水平，我們假設這將減少在幾乎所有 ALS 患者中觀察到的有毒 TDP-43 簇。

Preclinical experiments confirm that reduction of ataxin-2 levels modified survival and function in a mouse model of TDP-43 ALS. The Phase I/II study of BIIB105 in ALS is expected to read out early next year.

臨床前實驗證實，在 TDP-43 ALS 小鼠模型中，ataxin-2 水平的降低改變了生存和功能。 BIIB105在ALS中的I/II期研究預計將於明年初宣讀。

We continue to advance our R&D prioritization efforts with the goals of optimizing the value that our pipeline can deliver. This includes investing in areas where we have a strong conviction in the disease biology. We continue to invest in further data generation for LEQEMBI and zuranolone and remain focused on executing key clinical studies, including BIIB080 and BIIB105 as well as for litifilimab in lupus. We also made a decision to opt in to Denali antibody transport vehicle A beta program. With the ATV A beta, we aim to safely increase (inaudible) of A-beta antibody in the brain. This may enable improved plaque clearance and/or lower incidence of ARIA.

我們繼續推進我們的研發優先工作，以優化我們的管道可以提供的價值為目標。這包括投資於我們對疾病生物學有強烈信念的領域。我們繼續投資於 LEQEMBI 和 zuranolone 的進一步數據生成，並繼續專注於執行關鍵的臨床研究，包括 BIIB080 和 BIIB105 以及狼瘡中的 litifilimab 。我們還決定選擇加入 Denali 抗體運輸工具 A 測試版計劃。通過 ATV A beta，我們的目標是安全地增加（聽不清）大腦中的 A-beta 抗體。這可以改善斑塊清除和/或降低 ARIA 的發生率。

We are also deprioritizing programs based upon our integrated view of development, regulatory and on commercialization challenges. Recent updates include that we decided to terminate involvement in the development of BIIB093 in large hemispheric infarction and brain contusion due to operational challenges and strategic considerations.

我們還根據我們對開發、監管和商業化挑戰的綜合觀點，對項目進行優先排序。最近的更新包括，由於操作挑戰和戰略考慮，我們決定終止參與 BIIB093 在大面積半球梗死和腦挫傷中的開發。

We decided to pause initiation of the Phase IIb study of BIIB131 in acute ischemic stroke as we reassess whether we need to initiate the study.

我們決定暫停啟動 BIIB131 在急性缺血性中風中的 IIb 期研究，因為我們重新評估我們是否需要啟動該研究。

We discontinued BIIB132 in spinocerebellar ataxia type 3.

我們在 3 型脊髓小腦性共濟失調中停用 BIIB132。

We previously announced that we had refocused our investment in gene therapy, and we will continue to look to advance technology associated with the safe delivery of these therapies to the right targets in the body which we believe is one of the most critical scientific and technical challenges that is currently associated with this modality.

我們之前宣布我們已經重新調整了對基因治療的投資，我們將繼續尋求與將這些療法安全地輸送到體內正確目標相關的先進技術，我們認為這是最關鍵的科學和技術挑戰之一當前與此模式相關聯。

We also had previously announced that we exited ophthalmology research with goals of reallocating resources to areas where we believe there is a greater probability of success.

我們之前還宣布退出眼科研究，目標是將資源重新分配到我們認為更有可能成功的領域。

This will be an ongoing process, involving dynamic scientific prioritization and investment based on an ongoing assessment of probability of success, but we expect to complete our initial substantial review by midyear.

這將是一個持續的過程，涉及基於對成功概率的持續評估的動態科學優先排序和投資，但我們預計將在年中完成我們的初步實質性審查。

In conclusion, Biogen has had a significant number of accomplishments this past quarter, which we believe highlights the ability of our R&D organization to capitalize and deliver on groundbreaking science in the pursuit of new medicines for patients. With key assets in areas like Alzheimer's disease, depression, ALS and lupus, we believe the Biogen pipeline has the potential to deliver significant growth over the medium- and long-term.

總而言之，百健（Biogen）在上個季度取得了大量成就，我們認為這凸顯了我們的研發組織在為患者追求新藥方面利用和交付突破性科學的能力。憑藉在阿爾茨海默病、抑鬱症、ALS 和狼瘡等領域的關鍵資產，我們相信百健（Biogen）管道有可能在中長期實現顯著增長。

I will now pass the call over to Mike for the financial results.

我現在將電話轉給邁克，了解財務結果。

Thank you, Priya. Good morning, everyone. So I'll provide some highlights of our financial performance for the first quarter, and please note that all financial comparisons that you will hear are versus the third quarter of 2022.

謝謝你，普里亞。大家，早安。因此，我將提供我們第一季度財務業績的一些亮點，請注意，您將聽到的所有財務比較都是與 2022 年第三季度的比較。

Total revenue for the first quarter was $2.5 billion, and that's a decrease of 3% at actual currency and flat at constant currency.

第一季度的總收入為 25 億美元，按實際貨幣計算下降 3%，按固定匯率計算則持平。

Non-GAAP diluted earnings per share in the first quarter was $3.40, a decrease of 6%.

第一季度非 GAAP 攤薄後每股收益為 3.40 美元，下降 6%。

Total MS product revenue was $1.1 billion, a decrease of 19% at actual currency and 17% at constant currency. I'd like to provide a few points here regarding MS during the quarter. In the U.S., we continue to see the impact of TECFIDERA generics declines in the interferons and competition for TYSABRI. As we noted in our last call, Q1 is typically a seasonally weaker quarter for our MS business in the U.S., and that's driven by higher discounts and allowances and some channel dynamics. And as it relates to channel dynamics, we did see a greater-than-expected decrease in channel inventory which added a few percentage points to the overall global decline. And we believe this is likely related to tighter working capital management in wholesalers and specialty pharmacies, due to the rising interest rate environment.

MS 產品總收入為 11 億美元，按實際貨幣計算下降 19%，按不變貨幣計算下降 17%。我想在此提供有關本季度 MS 的幾點意見。在美國，我們繼續看到 TECFIDERA 仿製藥在干擾素和 TYSABRI 競爭中的影響下降。正如我們在上次電話會議中指出的那樣，對於我們在美國的 MS 業務而言，第一季度通常是季節性疲軟的季度，這是由更高的折扣和津貼以及一些渠道動態推動的。由於與渠道動態相關，我們確實看到渠道庫存下降幅度超過預期，這使全球整體下降幅度增加了幾個百分點。我們認為，這可能與利率上升環境下批發商和專業藥店更嚴格的營運資金管理有關。

In addition, VUMERITY is being impacted by both pricing pressure and a contraction of the oral segment of the market in the U.S. And as a reminder, in Q1 of last year, VUMERITY did benefit from a favorable Medicaid-related sales adjustment which also impacts the year-over-year comparison.

此外，VUMERITY 受到定價壓力和美國口腔市場收縮的影響。提醒一下，在去年第一季度，VUMERITY 確實受益於與醫療補助相關的有利銷售調整，這也影響了同比比較。

As far as Europe, as you know, we received a favorable decision relating to the TECFIDERA regulatory data and marketing protection in the EU, and that was assumed in our guidance. So we believe that TECFIDERA is entitled to regulatory marketing protection in EU until at least February of 2024, and we are working to enforce this protection. I would add that we did expect it would take some time following the decision for all generic products to be off the market, and we are assuming that this exit will accelerate in the near-term. Separately, we continue to enforce our patent which expires in 2028.

就歐洲而言，如您所知，我們收到了與歐盟 TECFIDERA 監管數據和營銷保護相關的有利決定，我們的指南中也假設了這一點。因此，我們認為 TECFIDERA 至少在 2024 年 2 月之前都有權在歐盟獲得監管營銷保護，我們正在努力實施這一保護。我要補充一點，我們確實預計所有仿製藥退出市場的決定需要一段時間，我們假設這種退出將在短期內加速。另外，我們繼續執行將於 2028 年到期的專利。

So as we look toward the remainder of the year, we do expect to see a slower rate of decline on a year-over-year basis versus what we saw in Q1. We've taken some actions which aim to improve the underlying revenue trajectory for our MS portfolio in the second half, including for VUMERITY in the U.S., and we're continuing to closely monitor the underlying market dynamics in MS closely.

因此，當我們展望今年剩餘時間時，我們確實預計與第一季度相比，同比下降速度會放緩。我們採取了一些行動，旨在改善下半年我們 MS 投資組合的基本收入軌跡，包括美國的 VUMERITY，我們將繼續密切關注 MS 的基本市場動態。

Moving to SMA. Global SPINRAZA revenue of $443 million was a decrease of 6% in actual currency and 2% at constant currency. In the U.S., SPINRAZA revenue decreased 10% due to fewer new patient starts and some channel dynamics as compared to the first quarter of last year. However, we do continue to see what we believe are signs of stabilization in our patient base.

轉向 SMA。 SPINRAZA 的全球收入為 4.43 億美元，按實際貨幣計算下降 6%，按固定匯率計算下降 2%。在美國，與去年第一季度相比，由於新患者開始減少和一些渠道動態， SPINRAZA 收入下降了10%。然而，我們確實繼續看到我們認為我們的患者群穩定的跡象。

Outside the U.S., revenue for SPINRAZA decreased 4% at actual currency and increased 2% at constant currency with competition more than offset by the timing of shipments in certain markets.

在美國以外，SPINRAZA 的收入按實際貨幣計算下降了 4%，按固定貨幣計算增長了 2%，競爭被某些市場的發貨時間所抵消。

Biosimilars revenue was $192 million, and that's a decline of 1% at actual currency and an increase of 4% at constant currency, and that's due to volume growth driven by the launch of our BYOOVIZ product, partially offset by continued pricing pressure for our anti-TNF products in Europe.

生物仿製藥收入為 1.92 億美元，按實際貨幣計算下降 1%，按固定貨幣計算增長 4%，這是由於我們的 BYOOVIZ 產品的推出推動了銷量增長，部分被我們的抗癌藥物的持續定價壓力所抵消-歐洲的TNF產品。

Alzheimer's disease revenue, which includes revenue from ADUHELM and the LEQEMBI collaboration equated to a headwind of $18 million to revenue. As a reminder, Beginning this quarter, our share of LEQEMBI commercial expenses in the U.S. is recorded as a component of revenue, thus the negative number this quarter. And for this line item, we expect this to continue to be negative in 2023 as ramping LEQEMBI commercialization expenses throughout the year are expected to exceed initial revenue.

阿爾茨海默病收入，其中包括來自 ADUHELM 和 LEQEMBI 合作的收入，相當於 1800 萬美元的收入逆風。提醒一下，從本季度開始，我們在美國的 LEQEMBI 商業費用份額被記錄為收入的一部分，因此本季度為負數。對於這一行項目，我們預計這將在 2023 年繼續為負，因為全年 LEQEMBI 商業化費用的增加預計將超過初始收入。

Total anti-CD20 revenue of $399 million was flat. Revenue from OCREVUS royalties increased 12%, which was partially offset by a 25% decline in revenue from our profit share on RITUXAN, and that was driven by biosimilar competition.

抗 CD20 總收入為 3.99 億美元，持平。來自 OCREVUS 特許權使用費的收入增長了 12%，這部分被我們在 RITUXAN 上的利潤分成收入下降 25% 所抵消，這是由生物仿製藥競爭推動的。

The anti-CD20 revenue line also included a $10 million operating loss related to LUNSUMIO. I'd note that our R&D expense for LUNSUMIO is also recorded as a component of the anti-CD20 revenue line.

抗 CD20 收入線還包括與 LUNSUMIO 相關的 1000 萬美元運營虧損。我要指出的是，我們對 LUNSUMIO 的研發費用也被記錄為抗 CD20 收入線的一個組成部分。

Important to note that starting in the second quarter, our pretax profit share percentage on RITUXAN, GAZYVA and LUNSUMIO will decrease from 37.5% to 35%, and that (inaudible) sales targets for GAZYVA as part of our contractual agreement with Genentech.

需要注意的是，從第二季度開始，我們在 RITUXAN 、 GAZYVA 和 LUNSUMIO 上的稅前利潤份額將從 37.5% 下降到 35%，並且作為我們與 Genentech 的合同協議的一部分， GAZYVA 的（聽不清）銷售目標。

Contract manufacturing royalty and other revenue of $319 million benefited from the timing of production of some contract manufacturing batches which includes LEQEMBI. While this line tends to vary from quarter-to-quarter, we do not expect this level of contract manufacturing revenue to continue throughout the remainder of 2023.

3.19億美元的合同製造特許權使用費和其他收入受益於包括 LEQEMBI 在內的一些合同製造批次的生產時間。雖然這條線往往每個季度都不同，但我們預計這種合同製造收入水平不會在 2023 年剩餘時間內持續下去。

A couple of details regarding Q1 expenses. For the first quarter, non-GAAP cost of sales was $663 million or 27% of revenue. This includes $45 million of idle capacity charges which Eisai no longer shares.

關於第一季度費用的一些細節。第一季度，非 GAAP 銷售成本為 6.63 億美元，佔收入的 27%。這包括衛材不再共享的 4500 萬美元閒置產能費用。

During Q1, we did see pressure on cost of sales associated with product mix. We saw increased contract manufacturing revenue which has a higher cost of sales including manufacturing revenue for LEQEMBI which is at minimal gross margin. We continue to expect our cost of sales as a percentage of revenue for the remainder of the year to be higher than the 22.4% that we saw for full year of 2022, and that's primarily as a result of product mix and idle capacity charges.

在第一季度，我們確實看到了與產品組合相關的銷售成本壓力。我們看到合同製造收入增加，銷售成本更高，包括毛利率最低的 LEQEMBI 製造收入。我們繼續預計今年剩餘時間的銷售成本佔收入的百分比將高於 2022 年全年的 22.4%，這主要是由於產品組合和閒置產能費用。

First quarter non-GAAP R&D expense was $571 million, and that compares to $552 million in the first quarter of last year. Non-GAAP SG&A was $603 million, and this compares to $635 million in the first quarter of 2022. The decrease in non-GAAP SG&A expense was driven primarily by cost savings initiatives which importantly were partially offset by investments to support new product launches and $31 million related to the termination of the co-promotion agreement with Eisai to Biogen's MS products in Japan.

第一季度非 GAAP 研發費用為 5.71 億美元，而去年第一季度為 5.52 億美元。非 GAAP SG&A 為 6.03 億美元，而 2022 年第一季度為 6.35 億美元。非 GAAP SG&A 費用的減少主要是由成本節約舉措推動的，這些舉措重要地被支持新產品發布的投資和 31 美元所抵消萬與終止與衛材在日本的百健（Biogen） MS 產品的共同推廣協議有關。

We continue to expect operating expenses to be lower in the second half of 2023 than in the first half. And as Chris mentioned, separate from the previously announced $1 billion cost savings initiative, we have initiated our Fit for Growth program in order to align our cost base with expected revenue while also investing in our growth opportunities. And we expect this program to have a modest impact on 2023 expenses and a more meaningful impact in 2024 and beyond, and we'll have more to say about this on our second quarter earnings call.

我們繼續預計 2023 年下半年的運營費用將低於上半年。正如 Chris 提到的，與之前宣布的 10 億美元成本節約計劃不同，我們啟動了 Fit for Growth 計劃，以使我們的成本基礎與預期收入保持一致，同時也投資於我們的增長機會。我們預計該計劃將對 2023 年的支出產生適度影響，並在 2024 年及以後產生更有意義的影響，我們將在第二季度財報電話會議上對此發表更多看法。

As for our balance sheet, we ended the quarter with $6 billion in cash and marketable securities, $6.3 billion in debt and roughly $300 million in net debt. Subsequent to the end of the quarter, we received approximately $813 million related to the sale of our equity stake in Samsung Bioepis which is not included in these cash figures. And this payment is the second payment related to this transaction which closed around this time last year, and we're expecting a third payment of approximately $438 million in April of 2024.

至於我們的資產負債表，我們在本季度結束時擁有 60 億美元的現金和有價證券、63 億美元的債務和大約 3 億美元的淨債務。本季度末，我們收到了約 8.13 億美元，與出售我們在 Samsung Bioepis 的股權有關，這不包括在這些現金數字中。這筆付款是與該交易相關的第二筆付款，大約在去年這個時候結束，我們預計 2024 年 4 月將進行第三筆付款，金額約為 4.38 億美元。

In the first quarter, we generated $455 million in cash flow from operations. CapEx was $67 million. Free cash flow was $389 million. So overall, we remain in a very strong financial position with significant cash and financial capacity to invest in growing the business over time.

第一季度，我們從運營中產生了 4.55 億美元的現金流。資本支出為 6700 萬美元。自由現金流為 3.89 億美元。因此，總的來說，我們的財務狀況仍然非常強勁，擁有大量現金和財務能力，可以隨著時間的推移投資於業務增長。

Let me now turn to financial guidance for full year 2023. We are reaffirming our full year guidance of a full year 2023 revenue decline in the mid-single-digit percentage range as compared to 2022 reported results and full year 2023 non-GAAP diluted earnings per share of between $15 and $16, and I would refer you to our press release for other important guidance assumptions.

現在讓我談談 2023 年全年的財務指導。我們重申我們的全年指導，即與 2022 年報告的結果和 2023 年全年非 GAAP 攤薄收益相比，2023 年全年收入下降中個位數百分比範圍每股 15 美元至 16 美元之間，我建議您參閱我們的新聞稿以了解其他重要的指導假設。

So in closing, Biogen continued to make strong progress against our business priorities in the first quarter. We remain focused on 3 potential launches in 2023 while continuing to be diligent in prioritizing our R&D pipeline, optimizing our operating model and also evaluating external opportunities. We expect that execution of these priorities will position us well for returning Biogen to sustainable growth and creating long-term value for our shareholders.

因此，最後，百健（Biogen）公司在第一季度繼續在我們的業務重點方面取得強勁進展。我們仍然專注於 2023 年的 3 項潛在發射，同時繼續努力確定我們的研發管道的優先次序，優化我們的運營模式並評估外部機會。我們預計，這些優先事項的執行將使我們能夠使百健（Biogen）恢復可持續增長並為我們的股東創造長期價值。

And with that, we will now open the call for questions.

有了這個，我們現在將開始提問。

(Operator Instructions) Our first question comes from Phil Nadeau of TD Cowen.

（操作員說明）我們的第一個問題來自 TD Cowen 的 Phil Nadeau。

Our question is on LEQEMBI reimbursement. What is Biogen's expectation for reimbursement post full approval? Do you expect coverage with evidence (inaudible) or some other form?

我們的問題是關於 LEQEMBI 報銷。百健（Biogen）對完全批准後的報銷期望是什麼？您希望通過證據（聽不清）或其他形式進行報導嗎？

And second, when do you think that will be clear? CMS has suggested that the coverage will be revised on the day of approval. Is that going to be the final determination or will there be subsequent revisions after that?

其次，你認為什麼時候會清楚？ CMS 建議在批准之日修改覆蓋範圍。是最後的決定還是之後會有後續的修改？

Chris, do we have you? Do you want to start?

克里斯，我們有你嗎？你想開始？

Yes. I hope if I got off mute. Yes, thanks. So nothing really new to report there, at least as far as CMS. CMS has said that following full approval that they will be making sure that the product is broadly available. I think there will be a question of existing registry, what type of registry, is there a cap on the registry that hasn't been defined at the moment.

是的。我希望我能保持靜音。對了謝謝。因此，至少就 CMS 而言，沒有什麼真正的新東西可以報告。 CMS 表示，在獲得完全批准後，他們將確保該產品廣泛可用。我想會有一個關於現有註冊管理機構的問題，註冊管理機構是什麼類型，註冊管理機構是否有一個目前尚未定義的上限。

I think what really is encouraging is that we're seeing an awful lot of support being mustered and encouragement of CMS to reimburse. As I noted earlier, the American Association of neurologists has come out strongly in favor. As a reminder, they sided more with CMS at the time of ADUHELM. So this is a change in position.

我認為真正令人鼓舞的是，我們看到了 CMS 獲得的大量支持和鼓勵報銷。正如我之前提到的，美國神經學家協會強烈支持這一觀點。提醒一下，在 ADUHELM 時代，他們更多地支持 CMS。所以這是一個位置的改變。

Over twice as many members of Congress have written to CMS and did for ADUHELM. And some of you may have been following the budget discussions in Washington and Congress, with also an encouragement for CMS to make the product available.

寫信給 CMS 和為 ADUHELM 寫信的國會議員人數是其兩倍多。你們中的一些人可能一直在關注華盛頓和國會的預算討論，同時也鼓勵 CMS 提供該產品。

So we continue to believe that the product will be made available. We would hope that it's not with a registry. There's no real need for a registry. And we don't really see why this product wouldn't be reimbursed like any other product for Medicare. But we're probably not going to see anything until after the PDUFA date.

因此，我們仍然相信該產品將可用。我們希望它不在註冊表中。沒有真正需要註冊表。而且我們真的不明白為什麼這個產品不能像任何其他醫療保險產品一樣得到報銷。但在 PDUFA 日期之前，我們可能不會看到任何東西。

We will now take a question from Paul Matteis of Stifel.

我們現在將接受 Stifel 的 Paul Matteis 的提問。

I wanted to follow up a little bit more on external investments as it relates to reshaping your pipeline. Chris, you've outlined rare disease, psychiatry and immunology historically. It would seem like if you're going to decrease the risk profile of your R&D strategy that immunology and rare would be more on the developmental side, whereas for a psychiatry asset you want something that was either clinically derisked or commercial. Is that the right way to think about it? And what's your appetite today for transacting before shoring up everything in-house?

我想跟進更多關於外部投資的信息，因為它與重塑您的管道有關。克里斯，您從歷史上概述了罕見病、精神病學和免疫學。似乎如果你要降低研發策略的風險預測，免疫學和罕見病將更多地放在發展方面，而對於精神病學資產，你想要的東西要么是臨床上的風險，要么是商業上的。這是正確的思考方式嗎？在內部支撐一切之前，您今天對交易的胃口是什麼？

Thanks, Paul. No, I think you've got that correct. I mean, you could certainly look at some tuck-in acquisitions on the rare side. We have, as I noted earlier, appointed Adam as Head of Corporate Development and Business Development. I think another key figure will be the appointment of a new Head of Research, and I would hope to have that person in place at least by the end of the summer. And that person, along with Priya and Adam, are really going to be the 3 that I'll be working with to think about certainly from a licensing point of view.

謝謝，保羅。不，我認為你是對的。我的意思是，你當然可以看看一些罕見的收購。正如我之前提到的，我們已經任命 Adam 為企業發展和業務發展主管。我認為另一個關鍵人物將是任命一位新的研究主管，我希望至少在夏末之前讓那個人到位。從許可的角度來看，那個人以及 Priya 和 Adam 真的將成為我要與之合作的 3 人。

In terms of more transactions, I think we would be more inclined to find something that is revenue-generating in the near-term. If you look at Biogen, really from 2025 onwards, I think the company has an ability to grow pretty significantly. But in the next couple of years, that's where we're in this -- the tide going out on MS and the tide coming in on new products. We obviously have a lever with cost that we can use, but external growth could also help us to manage that transition period.

就更多交易而言，我認為我們會更傾向於在短期內找到能產生收入的東西。如果你看看 Biogen，真的從 2025 年開始，我認為該公司有能力實現顯著增長。但在接下來的幾年裡，這就是我們所處的位置——MS 的退潮和新產品的湧入。我們顯然有一個可以使用的成本槓桿，但外部增長也可以幫助我們管理這個過渡期。

We will now take a question from Geoff Meacham of Bank of America.

我們現在將接受美國銀行的 Geoff Meacham 的提問。

Chris or Priya, on BIIB080, we've seen a lot of tau assets underwhelmed in trials as a monotherapy, and you guys though are in a unique position to assess tau along with LEQEMBI. So the question is, what do you need to see in Phase II to advance a combo? And strategically, how much of a priority do you think this would be?

Chris 或 Priya，在 BIIB080 上，我們已經看到許多 tau 資產作為單一療法在試驗中表現不佳，儘管你們處於評估 tau 和 LEQEMBI 的獨特位置。那麼問題來了，你需要在第二階段看到什麼才能推進連擊？從戰略上講，您認為這會有多重要？

Priya?

普里亞？

Yes. Thanks, Geoff. Great question. So I'll just step back and say, obviously, Alzheimer's disease is a very complex disease with multiple biologies and complex pathophysiology. We do see ourselves as pioneers in this space, and we have been successful with demonstrating the A-beta plaques as being central. And now we've kind of shifted gears to looking at tau.

是的。謝謝，傑夫。很好的問題。所以我退一步說，顯然，阿爾茨海默病是一種非常複雜的疾病，具有多種生物學和復雜的病理生理學。我們確實將自己視為該領域的先驅，並且我們已經成功地證明了 A-beta 斑塊的核心地位。現在我們已經換檔看 tau 了。

As you know, we had a lot of experience with extracellular tau, and this was actually not successful because BIIB092 didn't work with gosuranemab. And we have really focused now on knocking down all post-translational isoforms of tau. So that's what BIIB080 is aiming to do.

如您所知，我們在細胞外 tau 方面有很多經驗，但實際上並不成功，因為 BIIB092 不適用於 gosuranemab。我們現在真正專注於敲除 tau 的所有翻譯後亞型。這就是 BIIB080 的目標。

As we've shared, I mean, obviously, these numbers are small in the Phase Ib study that went online in a publication yesterday in major medicine. But very encouraging because we have seen close to 50% reduction of total tau and the sustained reduction post-dosing. So this is very encouraging.

正如我們所分享的，我的意思是，顯然，在昨天在主要醫學雜誌上發表的 Ib 期研究中，這些數字很小。但非常令人鼓舞，因為我們已經看到總 tau 減少了近 50%，並且在給藥後持續減少。所以這是非常令人鼓舞的。

As we kind of think about Alzheimer's leadership and we think about multiple therapies, we have to assess how tau knockdown kind of translates into clinical outcomes, how much is (inaudible). Because when you look at the mouse models, transgenic mouse models for tau, you do see that about 50% actually can rescue neuronal cell loss and memory. So it's encouraging, but we need to see more data from Phase II. That's exactly how we're approaching it.

當我們考慮阿爾茨海默氏症的領導力並考慮多種療法時，我們必須評估 tau 敲低如何轉化為臨床結果，有多少（聽不清）。因為當你觀察小鼠模型時，tau 的轉基因小鼠模型，你確實看到大約 50% 實際上可以挽救神經元細胞損失和記憶。所以這是令人鼓舞的，但我們需要看到更多來自第二階段的數據。這正是我們接近它的方式。

Eventually, I think we do believe strongly that this is going to be a multimodality space and patients will probably need more than one therapy. Now whether it will be combination or which -- where you have to determine whether it's synergistic or whether it could be additive, that remains to be seen. And I think we're going to let the data drive us on many of these questions. But we're looking at all of this very, very carefully.

最終，我認為我們確實堅信這將是一個多模態空間，患者可能需要不止一種療法。現在，它是組合還是哪種——你必須確定它是協同的還是可以疊加的，這還有待觀察。而且我認為我們將讓數據驅動我們解決其中的許多問題。但我們正在非常、非常仔細地審視所有這些。

Right now, we're focusing on tau knockdown, all isoforms, as well as our Phase I asset, which is BIIB113 which is looking at preventing tau aggregation. So that's how we're focusing our efforts.

現在，我們專注於 tau 敲低、所有亞型，以及我們的第一階段資產，即 BIIB113，它正在研究防止 tau 聚集。這就是我們集中精力的方式。

If I could just follow up on that though, I think, Priya, I mean this is -- Priya noted that we've been through the pipeline and we have deprioritized some programs. But that's not just in an effort to reduce cost, it's really to be able to focus resources on those assets that we think are most promising.

不過，如果我能繼續跟進，我想，Priya，我的意思是——Priya 指出我們已經完成了管道，我們已經取消了一些程序的優先級。但這不僅僅是為了降低成本，實際上是為了能夠將資源集中在我們認為最有前途的資產上。

I can tell you, following the announcement of these results in Sweden and then also publication of the article in Nature, there's been a lot of attention on BIIB080, particularly from neurology community. And I think this is one of those assets that we really want to focus on. We've actually already allocated more resources to accelerate this program. And as Priya said, this is really one of the first manifestations of what it means to build a leadership position in Alzheimer's as opposed to just launching one product in this space.

我可以告訴你，在瑞典公佈了這些結果，然後在《自然》雜誌上發表了這篇文章之後，BIIB080 受到了很多關注，尤其是來自神經學界的關注。我認為這是我們真正想要關注的資產之一。我們實際上已經分配了更多資源來加速該計劃。正如 Priya 所說，這確實是在阿爾茨海默氏症領域建立領導地位的第一個體現，而不是僅僅在該領域推出一種產品。

So most complex diseases do end up being combination therapies, and there is some likelihood that, that will be the case in Alzheimer's. And to your point, I think Biogen is pretty well placed in that regard. And we're certainly getting even external interest in this program.

因此，大多數複雜疾病最終都會採用聯合療法，而且阿爾茨海默氏症也有可能成為這種情況。就你的觀點而言，我認為百健（Biogen）在這方面處於非常有利的地位。我們甚至肯定會對此計劃產生外部興趣。

We will now take a question from Salveen Richter of Goldman Sachs.

我們現在將接受高盛的 Salveen Richter 的提問。

On LEQEMBI, could you discuss your strategy here with respect to infrastructure, particularly infusion centers and testing post a potential full approval and assuming broad coverage by CMS.

在 LEQEMBI 上，您能否在這裡討論您在基礎設施方面的策略，特別是輸液中心和測試發布潛在的完全批准並假設 CMS 廣泛覆蓋。

Sure. Thanks for the question. One of the most interesting things is that the companies actually went through a launch planning process with ADUHELM and actually commissioned a study to actually have a look and understand what the learnings of that are. And there's an awful lot of chicken-and-egg syndrome going on here. Until there's been an approved therapy and reimbursement, there often isn't enough investment in other areas. We see this with blood-based diagnostics, for example. They've been around, but there's no market for a blood-based diagnostic until you actually have an approved drug and a treatment. And the same is true really for the investment in infusion capacity and PET scans and lumbar punctures and even the neurology capacity.

當然。謝謝你的問題。最有趣的事情之一是，這些公司實際上與 ADUHELM 一起完成了啟動計劃流程，並委託進行了一項研究，以實際了解並了解其中的經驗教訓。這裡發生了很多雞生蛋還是蛋生雞的綜合症。在獲得批准的治療和報銷之前，通常不會在其他領域進行足夠的投資。例如，我們在基於血液的診斷中看到了這一點。它們已經存在，但在您真正獲得批准的藥物和治療之前，基於血液的診斷沒有市場。對輸液能力、PET 掃描和腰椎穿刺甚至神經學能力的投資也是如此。

So what we certainly are seeing is that there is a lot more interest. There are a lot of parties who are looking to invest in some of this infrastructure. But right now, the world is almost in a point of -- well, the starting gate is really CMS approval.

因此，我們當然看到的是人們對此產生了更多興趣。有很多各方都希望投資其中的一些基礎設施。但現在，世界幾乎處於一個點——嗯，真正的起點是 CMS 批准。

One of the things that we also learned was, you want to flex your commercial investment with the ability of the system to actually meet patients. I think one of the things that we would do differently and are doing differently is that, at the time Biogen ramped up a huge commercial machine in advance of reimbursement and in advance of some of that expansion. As we work with Eisai, we're being a lot more prudent in looking at, okay, let's make sure we're out there, we're educating physicians, we're thinking about who's the right patient for this and working with the different centers to make sure we know which centers are -- have the ability to see patients and process the patients with this complex treatment paradigm.

我們還了解到的一件事是，您想通過系統實際滿足患者的能力來調整您的商業投資。我認為我們會做不同的事情之一併且正在做不同的事情是，當時百健（Biogen）在報銷之前和部分擴張之前增加了一台巨大的商業機器。當我們與衛材合作時，我們更加謹慎地看待，好吧，讓我們確保我們在那裡，我們正在教育醫生，我們正在考慮誰是合適的患者，並與不同的中心，以確保我們知道哪些中心是——有能力看病人並用這種複雜的治療模式處理病人。

So it will expand. And I think some of that expanded already at the time of ADUHELM. But I do think that we'll see -- we'll get a better sense of where that's going once we have the confirmation of CMS's reimbursement.

所以會膨脹。而且我認為其中一些已經在 ADUHELM 的時候擴展了。但我確實認為我們會看到 - 一旦我們確認 CMS 的報銷，我們就會更好地了解它的發展方向。

We will now take a question from Umer Raffat of Evercore.

我們現在將接受 Evercore 的 Umer Raffat 的提問。

I thought I would get some clarity on the minus $19 million in collaboration profit share on lecanemab. And specifically, is there any color we can get on what the end user revenues could look like from this minus $38 million for the franchise for 1Q, even if it's a fraction of $1 million. It would just be very helpful.

我想我會清楚地了解 lecanemab 的合作利潤分成負 1900 萬美元。具體來說，我們是否可以從第一季度特許經營權減去 3800 萬美元的最終用戶收入中獲得任何顏色，即使它只是 100 萬美元的一小部分。這將非常有幫助。

And also, has Eisai indicated to you on where they are or what percentage of the commercial build-out has already been baked into this 1Q number or not? Because you can imagine there's a lot of investor concern around how much SG&A they could possibly build into this collaboration, especially in light of some of the concerns around the strained relationship from the past, et cetera.

此外，Eisai 是否向您說明了他們的位置，或者商業擴建的百分比是否已經計入這個 1Q 數字？因為你可以想像有很多投資者擔心他們可能會在這次合作中建立多少 SG&A，特別是考慮到過去對緊張關係的一些擔憂，等等。

Mike, do you want to take the first part of the question, and I'll talk about the commercial infrastructure statement.

邁克，你想回答問題的第一部分嗎？我將談談商業基礎設施聲明。

Sure. No, happy to. So Umer, as you know, the line item that you're referring to is the net of any revenue and commercial expense divided by 2, basically, as you noted. And we are -- we don't have a number that we're going to disclose on the revenue. What I can say is there was revenue during the quarter. It was minimal. The majority of patients on drug are cash pay. There's not reimbursement yet, as you know. And I think the real game, so to speak, starts when we have reimbursement should we get approval and get to that point.

當然。不，很高興。所以 Umer，如你所知，你所指的行項目是任何收入和商業費用的淨額除以 2，基本上，正如你所指出的。我們是——我們沒有要披露的收入數字。我能說的是本季度有收入。這是最小的。大多數服藥的患者都是現金支付。如你所知，還沒有報銷。我認為真正的遊戲，可以這麼說，在我們獲得報銷時開始，如果我們獲得批准並達到這一點。

So yes, revenue was minimal. The majority of it was cost divided by 2. And I'll let Chris speak to the ramp from here.

所以是的，收入微乎其微。其中大部分是成本除以 2。我會讓克里斯從這裡到坡道說話。

Yes. Thanks, Mike. Just in terms of relationship, I was in Japan last week and the CEO of Eisai and I had dinner. And I think our view is that the relationship and the partnership is actually working pretty effectively around the world. And as I said earlier, and I've said on a number of occasions, this is not a reach and frequency launch. So let's not think about the fact that we're just sending reps out and then that's going to have some impact directly on sales. There's an awful lot of certainly education that's being done. We actually -- Eisai has already reps out there in the field in the U.S. We, as Biogen, will likely -- will add reps in the -- at some point in the future, perhaps as early as next year, once reimbursement situation is known and the capacity increases.

是的。謝謝，邁克。就關係而言，上週我在日本，我和衛材的首席執行官共進晚餐。我認為我們的觀點是，這種關係和夥伴關係實際上在世界範圍內運作得非常有效。正如我之前所說，我已經在很多場合說過，這不是覆蓋面和頻率發射。所以我們不要考慮這樣一個事實，即我們只是派代表出去，然後這將直接對銷售產生一些影響。正在進行大量的肯定性教育。我們實際上 - 衛材已經在美國的現場代表了我們，作為百健（Biogen），我們很可能 - 將在未來的某個時候增加代表，也許最早在明年，一旦報銷情況是已知和容量增加。

As I say, one of the lessons that we have to learn is that you don't want to get ahead of that. This is -- the initial launch period is going to be really one that's constrained by the capacity. And so there's an awful lot of work working with the neurology community, educate how you diagnose the patient, the whole process in a practice of -- when do you get the PET scan or the lumbar puncture, when are the -- how do you schedule the MRIs, getting the reimbursement, understanding where the infusion centers are. So it's a pretty high-touch sell and customer relations at the start.

正如我所說，我們必須吸取的教訓之一是你不想超越它。這是——最初的啟動期將是一個真正受容量限制的時期。因此，與神經病學社區合作進行了大量工作，教育您如何診斷患者，整個過程的實踐——你什麼時候進行 PET 掃描或腰椎穿刺，什麼時候——你如何安排 MRI，獲得報銷，了解輸液中心的位置。因此，一開始這是一個相當高接觸的銷售和客戶關係。

I would say there's an initial investment, there'll be a second wave of investment once the CMS decision is known, and then probably a third wave of investment as the capacity builds and the patient numbers increase.

我會說有一個初始投資，一旦 CMS 決定已知，就會有第二波投資，然後隨著能力建設和患者數量的增加，可能會有第三波投資。

Our next question comes from Tim Anderson of Wolfe Research.

我們的下一個問題來自 Wolfe Research 的 Tim Anderson。

This is Alice [Nicholson] on for Tim Anderson. Just on Alzheimer's, so we're wondering what is Biogen's working assumption on how the profile of Lilly's donanemab will look relative to LEQEMBI. And past data would suggest it would be less safe with efficacy about the same. Is that how Biogen views the most likely outcome?

這是蒂姆安德森的愛麗絲[尼科爾森]。就阿爾茨海默氏症而言，我們想知道百健（Biogen）對禮來（Lilly）的 donanemab 相對於 LEQEMBI 的概況的工作假設是什麼。過去的數據表明，如果療效大致相同，它的安全性會降低。這是百健（Biogen）公司如何看待最有可能的結果？

Yes. Thanks for the question. I don't think we really look at it that way. When -- I think the world changed with the CLARITY study. If we went back 2 years ago, 3 years ago, a lot of still doubt amongst the neurology community, does the amyloid beta hypothesis really hold water. There's been a huge debate within the community about whether that's a valid target or not. CLARITY, I think, really starts to put that debate to rest.

是的。謝謝你的問題。我不認為我們真的那樣看。什麼時候——我認為世界隨著 CLARITY 研究而改變。如果我們回到 2 年前、3 年前，神經學界仍有很多疑問，β 澱粉樣蛋白假說是否真的站得住腳。關於這是否是一個有效的目標，社區內部一直存在著巨大的爭論。 CLARITY，我認為，真正開始平息這場辯論。

And -- but the studies were done over -- in the case of CLARITY IN an 18-month timeframe. But actually, what we're seeing is that the world has moved on. Those 18 months, yes, we would dramatically reduce plaque and we actually see that there is a benefit in terms of slower cognitive decline. But that's not where it's going to end. In all likelihood, the way this is shaping up is that you're going to have at some point a plaque clearing phase.

並且 - 但研究已經完成 - 在 CLARITY 的情況下，在 18 個月的時間範圍內。但實際上，我們看到的是世界已經向前發展。那 18 個月，是的，我們會顯著減少牙菌斑，而且我們實際上看到在減緩認知衰退方面有好處。但這不是它要結束的地方。很可能，這種情況的形成方式是您將在某個時候進入牙菌斑清除階段。

Then what happens after you've cleared the plaque? If you don't continue treating, the plaque is going to come back. So there's going to be, in all likelihood, a maintenance phase, that's where also the subcu formulation will be important.

那麼清除牙菌斑後會發生什麼？如果您不繼續治療，牙菌斑就會捲土重來。所以很可能會有一個維護階段，這也是 subcu 公式很重要的地方。

And then as we all know, MCI is not really early stage Alzheimer's. By the time you have MCI, by the time you have symptoms, you probably already have a maximum load of plaque. There are probably people on this call who are accumulating plaque in their brains as we speak and they don't know it. And by the time a certain amount of plaque has risen, then you've already had a certain amount of neuronal death. And right now, we don't know how to restore neurons.

然後眾所周知，MCI 並不是真正的早期阿爾茨海默氏症。當您患有 MCI 時，當您出現症狀時，您的斑塊可能已經達到最大負荷。可能有人在我們講話時大腦中積聚了斑塊，但他們並不知道。當一定數量的斑塊上升時，你已經有一定數量的神經元死亡。而現在，我們不知道如何恢復神經元。

So there's also going to be, with the advance of blood diagnostics but also even Eisai Biogen study ahead in looking at earlier patients, as one neurologist said, we're not looking at this any longer as a 4- to 8-year disease, but we're looking at this over the timeframe of a 25-year period.

因此，隨著血液診斷學的進步，甚至衛材百健（Eisai Biogen）研究早期患者的研究，正如一位神經學家所說，我們不再將其視為一種 4 至 8 年的疾病，但我們是在 25 年的時間框架內審視這個問題。

So if I look at donanemab (inaudible) in some ways, it will be good if their data are positive, that it further reinforces the amyloid -- the beta amyloid hypothesis. And also there's -- we've always seen in new markets if there's more players that those markets develop faster.

因此，如果我以某種方式觀察 donanemab（聽不清），如果他們的數據是積極的，那將是一件好事，它會進一步加強澱粉樣蛋白——β 澱粉樣蛋白假說。還有——我們總是在新市場中看到，如果有更多的參與者，這些市場發展得更快。

But this donanemab thought process of I'm just treating to a certain amount of plaque reduction. Most neurologists I talked to don't believe that fits anymore with the way we're thinking about the treatment of Alzheimer's. So I think it will be there, but I think it's going to be -- it's not really going to be adopted in the same way that people thought when that study was conceived. So let's say, I think it will be good if there's other players in the market. But I don't think we are too concerned about competing with donanemab.

但是這個 donanemab 的思維過程只是治療一定量的斑塊減少。與我交談過的大多數神經學家認為這不再符合我們對阿爾茨海默氏症治療的思考方式。所以我認為它會在那裡，但我認為它會——它不會像人們在構思這項研究時所想的那樣真正被採用。這麼說吧，我認為如果市場上有其他參與者，那會很好。但我認為我們並不太擔心與 donanemab 的競爭。

We will now take a question from Michael Yee of Jefferies.

我們現在將接受 Jefferies 的 Michael Yee 的提問。

We had a question around your expectations post reimbursement around the LEQEMBI launch. Appreciating you can't give too many specifics, but how should we think about that in the context of consensus modeling $40 million to $45 million, $400 million for next year? Maybe you could help rightsize how things start off, whether there's a bolus or a number of patients already in the queue and in the context of how we should be modeling the next 4 to 6 quarters.

我們對您對 LEQEMBI 發布後報銷的期望有疑問。感謝您不能提供太多具體細節，但我們應該如何在共識模型的背景下考慮這一點 4000 萬至 4500 萬美元，明年 4 億美元？也許你可以幫助調整事情的開始方式，無論是有推注還是隊列中已經有一些患者，以及我們應該如何為接下來的 4 到 6 個季度建模。

Yes, I wish I could give you some more guidance on that. As I'd like to say, I'm pretty confident in the 3- to 5-year outlook. The next 18 months are a little more difficult to model even for us. There is an awful lot of interest. There probably will be some queuing. There is going to be a question around the -- how quickly can the system flex.

是的，我希望我能給你更多的指導。正如我想說的，我對 3 到 5 年的前景非常有信心。接下來的 18 個月甚至對我們來說都更難建模。人們非常感興趣。可能會有一些排隊。圍繞這個問題將會有一個問題——系統能多快靈活。

The way I would think about it is and the way I look at Biogen is I think zuranolone actually is a product that can actually contribute faster to our sales growth in 2024. And I do think that one, yes, it's a paradigm shift, but there's a clear patient benefit and we don't have all of the infrastructure challenges to overcome. So to me, I look more to the impact of zuranolone next year. And the -- we'll be able to give a lot better idea by the end of this year once we see what's the initial takeoff in the first 6 months once CMS issues its reimbursement.

我的想法是，我對百健的看法是，我認為 zuranolone 實際上是一種可以在 2024 年為我們的銷售增長做出更快貢獻的產品。我確實認為，是的，這是一種範式轉變，但是這對患者有明顯的好處，而且我們不需要克服所有的基礎設施挑戰。所以對我來說，明年我會更多地關注 zuranolone 的影響。而且 - 我們將能夠在今年年底之前給出更好的想法，一旦我們看到 CMS 發出報銷後前 6 個月的初始起飛是什麼。

Our next question comes from Robyn Karnauskas of Truist Securities.

我們的下一個問題來自 Truist Securities 的 Robyn Karnauskas。

So just on if there is a registry, can you just talk to if you would foresee a registry being how much of a bottleneck it might create? How might it be paid for? And so help us, when we see that decision, understand what the challenges would be or it may not be as cumbersome as some might think?

那麼，如果有一個註冊管理機構，如果您預見到註冊管理機構可能會造成多大的瓶頸，您能否談談？如何支付？因此，當我們看到該決定時，請幫助我們了解挑戰是什麼，或者它可能不像某些人想像的那樣麻煩？

Well, there are certainly versions of a registry that are not particularly cumbersome, and the devil is going to be in the detail. That's why, again, we would hope that actually CMS reimburses this product just like any other product.

好吧，肯定有一些版本的註冊表不是特別麻煩，細節決定成敗。這就是為什麼我們再次希望 CMS 像任何其他產品一樣報銷該產品。

When you think that diverse and underserved patients in the health care system suffer disproportionately more in Alzheimer's, it would seem that increasing the barriers for those patients by the need for navigating a registry would be highly unfair to those patients. But we'll wait and see.

當你認為醫療保健系統中多樣化和服務不足的患者在阿爾茨海默氏症中遭受的痛苦更多時，似乎通過需要瀏覽註冊表來增加這些患者的障礙對這些患者來說是非常不公平的。但我們拭目以待。

Our belief is that the data from CLARITY are extremely clear. The benefits are by no means limited to what you see in the CDR Sum of Boxes. As Priya said, when you look at those activities of daily life, which are evaluated by people who are with these patients every single day, and you have half a dozen measures and each one of them individually is statistically significant, that says to me that -- and versus placebo, this says to me that the people who see these patients every day understand the benefit of this new medicine and treatment.

我們相信來自 CLARITY 的數據非常清晰。好處絕不僅限於您在 CDR Sum of Boxes 中看到的內容。正如 Priya 所說，當你觀察日常生活中的那些活動時，這些活動每天都由與這些患者在一起的人進行評估，並且你有六項措施，而且每一項措施都具有統計意義，這對我來說就是- 與安慰劑相比，這對我來說意味著每天看到這些患者的人都了解這種新藥和治療的好處。

And so I think I think the data are compelling, and we would hope that there isn't a registry. And if there is a registry that it is minimally cumbersome for patients to act and their caregivers to navigate.

所以我認為我認為這些數據很有說服力，我們希望沒有註冊表。如果有一個登記處，那麼患者的行為和他們的護理人員的導航就不會那麼麻煩。

We will now take a question from Marc Goodman of SVB Securities.

我們現在請 SVB 證券公司的馬克·古德曼提問。

Priya, maybe you could just help us with what's similar about these programs that were stopped? I mean, obviously, there's a few in stroke and a few others. But what is similar there? And it was interesting, strokes in Phase III, so does that mean that we could see some other late-stage assets that get [cold] from the pipeline? Just philosophically, just big picture, how you've thought about these decisions.

Priya，也許你可以幫助我們了解這些已停止的程序的相似之處？我的意思是，很明顯，有一些中風和其他一些。但是那裡有什麼相似之處？有趣的是，第三階段中風，這是否意味著我們可以看到其他一些後期資產從管道中 [cold]？只是從哲學上來說，只是大局觀，你是如何考慮這些決定的。

Sure. So the way we've thought about these decisions is really we're looking at every program in great depth and several times over and thinking about what are the options, what are the operational and strategic and regulatory challenges but also opportunities. And so really, it's an integrated view of where we believe that our resources would be better applied to other programs in our portfolio currently. That is, I would say, the common denominator across all the decisions that you're hearing from us today. We believe that we should be spending time elsewhere.

當然。因此，我們考慮這些決定的方式實際上是，我們正在深入研究每個項目，並多次研究並思考有哪些選擇，運營、戰略和監管方面的挑戰以及機遇是什麼。所以真的，這是一個綜合的觀點，我們認為我們的資源可以更好地應用於我們目前投資組合中的其他項目。也就是說，我想說的是，您今天從我們這裡聽到的所有決定的共同點。我們認為我們應該把時間花在其他地方。

Now having said that, you said the BIIB093 is in Phase III. I can't really comment on what might be the outcome. But for now, we are really discontinuing development.

話雖如此，你說 BIIB093 處於 III 期。我無法真正評論可能的結果。但就目前而言，我們真的停止了開發。

We will now take a question from Terence Flynn of Morgan Stanley.

我們現在將接受摩根士丹利的特倫斯·弗林 (Terence Flynn) 的提問。

Great. Maybe a follow-up for Chris on zuranolone. I think during your prepared remarks, you noted that this asset is underestimated. And based on your answer to the prior question, it sounds like potentially you think there could be some upside to numbers. So should we read that as -- is that the takeaway, that you think there's upside your consensus estimates here for that asset? And then just any update on the commercial footprint in terms of the build and what that might ultimately look like over time.

偉大的。也許是克里斯對 zuranolone 的後續行動。我認為在您準備好的發言中，您指出該資產被低估了。根據您對上一個問題的回答，聽起來您可能認為數字可能有一些好處。那麼我們是否應該將其解讀為 - 是外賣，您認為您對該資產的共識估計有上升空間？然後就構建方面的商業足跡進行任何更新，以及隨著時間的推移最終可能會是什麼樣子。

Yes. Thanks, Marc. It is interesting, and I look at it, and I take what analysts and investors say very seriously. And -- but I definitely see that, as a company, we see a much higher potential for zuranolone than what the Street has. And I'm trying to figure out why there is that gap, I haven't really come up with a good answer other than I think the investment community has been so focused on things like rare diseases and oncology where you've got some very clear biomarkers, you've got some very precise medicine. Precision medicine is a big thing in both of those fields. And we're back into primary care. We're back into a disease state that is -- has a lot more challenge in actually diagnosing, even as you look at different indications. For instance, we take something like bipolar depression and major depressive disorder and general anxiety disorder, and these things are often seen in the same patient.

是的。謝謝，馬克。這很有趣，我看著它，我非常重視分析師和投資者所說的話。而且——但我肯定地看到，作為一家公司，我們認為 zuranolone 的潛力比街上的要大得多。我正試圖弄清楚為什麼存在這種差距，除了我認為投資界一直非常關注罕見疾病和腫瘤學等領域之外，我還沒有真正想出一個好的答案，在那裡你有一些非常明確的生物標誌物，你有一些非常精確的藥物。精準醫學在這兩個領域都是一件大事。我們又回到了初級保健。我們又回到了一種疾病狀態——在實際診斷方面面臨更多挑戰，即使你看的是不同的適應症。例如，我們拿雙相抑鬱症、重度抑鬱症和廣泛性焦慮症這樣的病症，這些病症經常出現在同一個病人身上。

And indeed, when you actually talk to psychiatrists, they'll tell you that this is a -- this is truly personalized medicine. Psychiatrist tends to be less swayed by guidelines, by what KOLs say and more about understanding the individual patient needs. So this is not what people have been used to looking at. It's all clinical data and everything else. And so I think from a commercial model point of view, the market is having a little bit more difficulty understanding how does the physician make a decision about their patient.

事實上，當你真正與精神科醫生交談時，他們會告訴你這是——這是真正的個性化醫療。精神科醫生往往不太受指導方針、KOL 所說的影響，而更多地了解患者的個體需求。所以這不是人們習慣看的東西。這是所有臨床數據和其他一切。因此，我認為從商業模式的角度來看，市場在理解醫生如何對患者做出決定方面有點困難。

I can tell you is that we've talked to a lot of patients. We've had patients into our global executive committee. We had physicians talk to our global executive committee. It is a much different approach than certainly what our company has been used to in terms of dealing with neurologists. But what is also really clear is that there is a significant unmet need. Patients cycle through therapy. They're not adequately satisfied by those therapies. There's an awful lot of stigma here and staying on medicine only reinforces that stigma. I've talked to physicians who say, we have people coming into the emergency room, and we can't help them. There are no beds. We give them an SSRI or something like that and hope that someone is going to watch them for 6 weeks.

我可以告訴你的是，我們已經和很多病人談過。我們已經讓患者進入我們的全球執行委員會。我們讓醫生與我們的全球執行委員會進行了交談。在與神經科醫生打交道方面，這肯定與我們公司習慣使用的方法大不相同。但同樣非常清楚的是，存在大量未滿足的需求。患者循環治療。他們對這些療法不夠滿意。這裡有很多恥辱感，繼續吃藥只會加深這種恥辱感。我和醫生談過，他們說，我們有人進入急診室，我們無法幫助他們。沒有床。我們給他們 SSRI 或類似的東西，並希望有人會觀察他們 6 週。

So the fact that you can have a medicine that responds quickly. If you're in a depressed phase, this is a very dark part of people's lives. And when you hear the patient stories about how suddenly their life has changed. We had a patient who've been suffering on and off for almost 20 years, a mother of 3 children, grandmother of 5 children. And within days, she felt better. She's gotten her qualification as a fitness structure. She's going now for a pilot license. I mean this is really transformational for so many patients. And that's what I really go by in.

所以事實上你可以有一種快速反應的藥物。如果你處於抑鬱階段，這是人們生活中非常黑暗的部分。當你聽到病人講述他們的生活是多麼突然地改變時。我們有一位患者斷斷續續地承受了將近 20 年的痛苦，她是 3 個孩子的母親，5 個孩子的祖母。幾天之內，她感覺好多了。她獲得了健身結構的資格。她現在要去考飛行員執照。我的意思是這對很多患者來說真的是變革性的。這就是我真正經歷的。

Another way I look at it, Marc, is I look at when you're recruiting salespeople. We have 27 roles. The first line, manager roles in our field force that we're looking at. We had over 4,000 applications for those roles. And these are people who are working for great companies and supporting great products. And I remember when we were launching AUBAGIO and there weren't high expectations of AUBAGIO. But when we built that field force, we were able to recruit a great team.

馬克，我看待它的另一種方式是我看你什麼時候招聘銷售人員。我們有 27 個角色。第一行，我們正在研究的現場工作人員中的經理角色。我們收到了 4,000 多份申請這些職位的申請。這些人為偉大的公司工作並支持偉大的產品。我記得當我們推出 AUBAGIO 時，人們對 AUBAGIO 的期望並不高。但是，當我們建立了那支現場部隊後，我們就能夠招募到一支優秀的團隊。

And salespeople do their own diligence. They tend to want to be a part of medicines that they see as important. And so I see a lot of signs where I think this is going to resonate with the patient. It is certainly resonating with the sales folks that we are recruiting. And I certainly hear it from a lot of key opinion leaders.

銷售人員盡職盡責。他們往往希望成為他們認為重要的藥物的一部分。所以我看到很多跡象，我認為這會引起患者的共鳴。這肯定引起了我們正在招聘的銷售人員的共鳴。我當然從很多關鍵意見領袖那裡聽到過。

So it's hard to -- the only thing that I see where there's a note of caution is that it is clearly a paradigm shift, and I'd like to say it's easier to change your spouse of 20 years than it is sometimes a physician's prescribing habits because physicians do rely on their experience. But I do think there is a major unmet need here, and I actually think there's an awful lot of potential. I'm very excited about this product. I think if I just listen to patients, I always like to say if there is an unmet need and I can see a differentiation versus existing therapy, the drug will be a success.

所以很難——我看到唯一需要注意的是，這顯然是一種範式轉變，我想說的是，改變你結婚 20 年的配偶比有時醫生開處方更容易習慣，因為醫生確實依賴於他們的經驗。但我確實認為這裡有一個主要的未滿足需求，而且我實際上認為有很大的潛力。我對這個產品感到非常興奮。我認為如果我只是聽取患者的意見，我總是喜歡說如果有未滿足的需求並且我可以看到與現有療法的差異化，那麼該藥物將會成功。

Our next question comes from Jay Olson of Oppenheimer.

我們的下一個問題來自奧本海默的傑伊·奧爾森。

Congrats on all the progress. Could you talk about the ideal capital structure for Biogen? And how much incremental debt could you take on for the purpose of business development?

祝賀所有的進步。您能談談百健（Biogen）理想的資本結構嗎？為了業務發展，您可以承擔多少增量債務？

Mike, do you want to take that one?

邁克，你要拿那個嗎？

Yes, I'll take that one. Thank you for the question, Jay. So we ended the quarter with about $6 billion in cash. And as we mentioned, we received the payment from Samsung for roughly $830 million subsequent to the end of the quarter. So we're approaching $7 billion of cash on hand. Our EBITDA level is roughly $3 billion. And on a gross debt basis, we've got roughly 2 turns. Obviously, net debt is close to 0, it's actually negative if you pro forma for the Samsung payment.

是的，我會拿那個。謝謝你的問題，傑伊。因此，我們在本季度結束時擁有約 60 億美元的現金。正如我們提到的，我們在本季度末收到了三星支付的大約 8.3 億美元的款項。因此，我們手頭的現金接近 70 億美元。我們的 EBITDA 水平約為 30 億美元。在總債務的基礎上，我們大約有 2 個回合。很明顯，淨負債接近於0，如果對三星付款進行備考，實際上是負數。

So there is incremental room. I think that just illustratively, if you added a turn of leverage, you'd be at 3x growth, you'd still be very modest net. And you add that to the cash, that puts you kind of north of or in the ZIP code of about $10 billion that you've got of kind of dry powder, so to speak.

所以還有增量空間。我認為這只是說明性的，如果你增加槓桿作用，你將實現 3 倍的增長，你的淨值仍然非常適中。你把它加到現金上，這讓你有點像北方或郵政編碼中的大約 100 億美元，你有一種干火藥，可以這麼說。

I wouldn't suggest that we would add incremental debt just to add it, but for the right opportunity, the right BD opportunity, et cetera, I think we've got a lot of flexibility in our capital structure.

我不會建議我們只是為了增加債務而增加增量債務，但對於合適的機會，合適的 BD 機會等等，我認為我們的資本結構有很大的靈活性。

We know you all have other calls to get to, so operator, can we please take one more question.

我們知道你們還有其他電話要接，所以接線員，我們可以再回答一個問題嗎？

We now take a question from Colin Bristow of UBS.

我們現在接受瑞銀 Colin Bristow 的提問。

And also welcome, Chuck. We're excited to be working with you again. On subcut LEQEMBI, what does FDA specifically said is required for approval? And then can you just speak to how important the [subcut] formulation is to the commercial story? What proportion of patients would it allow you access to the infusion or not?

也歡迎查克。我們很高興能再次與您合作。關於 LEQEMBI 子切面，FDA 明確表示需要什麼才能獲得批准？然後你能談談 [subcut] 公式對商業故事有多重要嗎？有多大比例的患者允許您使用輸液？

And then just a sort of a subpart on the commercial part. The VHA excluding APOE4 [homozygotes]. Can you just speak to the risk that you see either as a labeling or commercial risk on full approval and as access broadens?

然後只是商業部分的一個子部分。不包括 APOE4 [純合子] 的 VHA。您能否談談您認為在完全批准和訪問範圍擴大時作為標籤或商業風險的風險？

Okay. Thanks, Colin. I can start -- Yes, I can start with the subcutaneous formulation. So the plan is on track, and Eisai has said that they would be filing by Q1 2024. Just to back up, the evaluation is being conducted in the Phase III open-label extension by a subcutaneous sub-study. And Eisai has also stated that they have discussed the requirements for proceeding with this filing and generating the data and then subsequent filing with FDA and other regulators. And they believe that the strategy currently does allow for an evaluation of PK, PD and safety, which would be required.

好的。謝謝，科林。我可以開始——是的，我可以從皮下製劑開始。因此該計劃正在按計劃進行，衛材表示他們將在 2024 年第一季度提交申請。為了支持，正在通過皮下子研究在 III 期開放標籤擴展中進行評估。衛材還表示，他們已經討論了進行此備案和生成數據以及隨後向 FDA 和其他監管機構備案的要求。他們認為，該策略目前確實允許對 PK、PD 和安全性進行評估，這是必需的。

I'll move to the next aspect. I think that you asked was about the APOE4 homozygotes. So Eisai presented some of these data at ADPD and also made comments on this topic. And they believe that really the data set was rather small. The number of APOE4 homozygotes was quite small. They don't believe that the overall conclusions are different in terms of CLARITY AD and confidence in the data.

我將轉到下一個方面。我認為您問的是關於 APOE4 純合子的問題。因此，衛材在 ADPD 上展示了其中一些數據，並就此主題發表了評論。他們認為數據集確實很小。 APOE4 純合子的數量非常少。他們不認為總體結論在 CLARITY AD 和數據置信度方面有所不同。

The other aspect here to keep in mind is that actually many of the secondary endpoints favored LEQEMBI. So there could be a component of placebo not declining as much in this comparator group, and that was one of the points that they made as well.

這裡要記住的另一個方面是，實際上許多次要終點有利於 LEQEMBI。因此，在這個比較組中，安慰劑的成分可能沒有下降那麼多，這也是他們提出的觀點之一。

Now with regards to the commercial view on subcutaneous, I'm going to turn it to either Chris or Mike.

現在關於皮下的商業觀點，我將把它轉向 Chris 或 Mike。

Yes. I mean I think on -- go ahead, Chris.

是的。我的意思是我繼續思考——繼續吧，克里斯。

Yes. No, I was going to say on the commercial view of subcutaneous, this will be kind of groundbreaking and then we'll have to see how that plays out over time as patients with Alzheimer's, along with their caretakers, are maybe moving to more of a maintenance mode for their treatment. This could be something that could be very valuable and particularly for patients who have a distance to travel to get to an infusion center to be able to self-administer at home and something that we think could have a lot of potential. So more to come on that over time. We'll expect to hear more about it over the next 9 or so months, and we think it could be an important differentiator if it comes together.

是的。不，我要說的是皮下注射的商業觀點，這將是一種開創性的，然後我們將不得不看看它隨著時間的推移會如何發揮作用，因為阿爾茨海默氏症患者及其護理人員可能會轉向更多他們治療的維護模式。這可能是非常有價值的東西，特別是對於需要長途跋涉才能到達輸液中心以便能夠在家中自行管理的患者，我們認為這可能具有很大的潛力。隨著時間的推移，會有更多的事情發生。我們希望在接下來的 9 個月左右聽到更多關於它的信息，我們認為如果它結合在一起，它可能會成為一個重要的差異化因素。

Thanks everybody now.

現在謝謝大家。

I was just going to add, Chuck, we don't really see that the biweekly infusion as being a (inaudible) right now for that (inaudible) infusion. But it does, as Mike said, as we think about if we are able to get a maintenance indication and we are able to get blood diagnostics, the length of time that a patient will be on drug potentially will change in the future and therefore the subcu would certainly make a difference in that scenario. Back to you, Chuck.

我只是想補充一點，查克，我們真的不認為每兩週一次的輸液現在是一次（聽不清）輸液（聽不清）。但正如 Mike 所說，正如我們所考慮的那樣，如果我們能夠獲得維持適應症並且能夠進行血液診斷，那麼患者服用藥物的時間長度可能會在未來發生變化，因此subcu 肯定會在這種情況下有所作為。回到你身邊，查克。

Thanks, Chris. So thank you all for your attention this morning. You can always follow up with the Investor Relations team, and this will conclude our call.

謝謝，克里斯。感謝大家今天早上的關注。您可以隨時跟進投資者關係團隊，這將結束我們的通話。

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。您現在可以斷開連接。