Biogen Inc (BIIB) 2024 Q3 法說會逐字稿

Good morning. My name is Cynthia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen third-quarter 2024 earnings call and business update. (Operator Instructions) Today's conference is being recorded. Thank you.

早安.我叫辛西婭，今天我將擔任你們的會議操作員。此時，我謹歡迎大家參加百健 (Biogen) 2024 年第三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 Dr. Stephen Amato, Senior Director of Investor Relations. Dr. Amato, you may begin your conference.

現在我想將會議交給投資者關係高級總監史蒂芬·阿馬托博士。阿馬托博士，您可以開始會議了。

Thank you. Good morning, and welcome to Biogen's third-quarter 2024 earnings call. During this call, we'll make forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review.

謝謝。早安，歡迎參加百健 (Biogen) 2024 年第三季財報電話會議。在本次電話會議中，我們將做出前瞻性陳述，其中涉及可能導致實際結果與我們的前瞻性陳述有重大差異的風險和不確定性。我們在向 SEC 提交的文件中提供了完整的風險因素列表，我鼓勵您查看。

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

我們的收益發布和與我們的業績相關的其他文件以及本次電話會議中討論的 GAAP 和非 GAAP 業績之間的調節表可以在 biogen.com 的投資者部分找到。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。

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; Mike McDonnell, Chief Financial Officer; as well as our Head and President of North America, Alisha Alaimo, who will be available for Q&A.

我們的總裁兼執行長 Chris Viehbacher 也參加了今天的電話會議。 Priya Singhal 博士，開發主管；麥克‧麥克唐納，財務長；以及我們的北美地區負責人兼總裁 Alisha Alaimo，她將出席問答環節。

We will make some opening comments, and then we'll move to the Q&A session. To allow us to get through as many questions as possible, we kindly ask that you limit yourself to one question.

我們將發表一些開場評論，然後進入問答環節。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。

I will now turn the call over to Chris.

我現在將把電話轉給克里斯。

Thank you, Steve. Good morning, everyone. I'll start first by thanking you, Steve for stepping up as interim Head of IR and done a great job of preparing us for this quarter. Also earlier this week, we announced the retirement plans of our CFO, Mike McDonnell, and also the appointment of his successor, Robin Kramer. But Mike is still very firmly in the saddle as CFO, and we will be recognizing his significant contribution to Biogen with the fourth quarter earnings call later.

謝謝你，史蒂夫。大家早安。首先，我要感謝史蒂夫擔任臨時 IR 主管，並為我們為本季做好準備做了出色的工作。同樣在本週早些時候，我們宣布了首席財務官邁克麥克唐納 (Mike McDonnell) 的退休計劃，並任命了他的繼任者羅賓克萊默 (Robin Kramer)。但麥克仍然非常堅定地擔任財務官，我們將在稍後的第四季財報電話會議上認可他對百健（Biogen）的重大貢獻。

So I think Biogen has made significant and very strong progress over the last two years. And I do think the company is well positioned for the future. Our launches are progressing well with good sequential quarter-over-quarter growth. Our cost base has been significantly reduced, but more importantly, a value-for-money approach to spending, I think, has been embedded in our culture. The acquisitions we've done to date have been well received and are already creating value. And I think we have a strong late-stage pipeline emerging.

因此，我認為百健（Biogen）在過去兩年中取得了重大且非常強勁的進展。我確實認為該公司已經為未來做好了準備。我們的產品發布進展順利，環比成長良好。我們的成本基礎已顯著降低，但更重要的是，我認為物有所值的支出方式已融入我們的文化中。我們迄今為止所做的收購受到了好評，並且已經在創造價值。我認為我們有一個強大的後期管道正在出現。

So if we turn first to the launches, let's start talking about LEQEMBI. Now, although, LEQEMBI revenue in the US continues to be below the expectations of our collaboration and the prescriber base is not expanded to the extent that we had anticipated, global revenue still grew by 66% in the third quarter as compared to the second quarter. And we've got continued uptake outside the US and new prescriber growth of nearly 40% in the US. The collaboration continues to refine the commercial strategy, and we are seeing benefits from an increase in our sales force, really who started out there in the field from first of September. And we continue to evaluate opportunities to potentially accelerate our business.

因此，如果我們先討論發布，讓我們開始談論 LEQEMBI。現在，儘管LEQEMBI在美國的營收持續低於我們合作的預期，處方者基礎也沒有擴大到我們預期的程度，但第三季全球營收仍比第二季成長了66% 。我們在美國以外地區的使用率持續上升，美國的新處方者增加了近 40%。此次合作不斷完善商業策略，我們也看到了銷售隊伍的壯大所帶來的好處，他們實際上是從 9 月 1 日起就開始涉足該領域的。我們將繼續評估可能加速我們業務發展的機會。

Now, we've continued to see some health care systems who are treating expand and extend and extending their treatment sites in the US. And more recently, we're starting to see large infusion networks activating in high-population geographies to help absorb patient demand. We've been encouraged by the rate of uptake outside the US, including Japan, where revenue nearly doubled from the previous quarter. And I think there's been terrific launch activities in particular, Japan and China. It does seem like a single payer system has also enabled that kind of growth.

現在，我們繼續看到一些正在美國進行治療的醫療保健系統不斷擴大和擴大其治療地點。最近，我們開始看到大型輸液網絡在人口稠密地區啟動，以幫助滿足患者需求。我們對美國以外地區（包括日本）的採用率感到鼓舞，日本的營收比上一季幾乎翻了一番。我認為特別是在日本和中國，推出活動非常精彩。單一支付系統似乎也促進了這種成長。

And overall, we expect continued sequential growth quarter-on-quarter for LEQEMBI over the near term. We believe there are a few future potential catalysts that could accelerate uptake, including the potential availability of IV maintenance as soon as next year, a subcutaneous formulation for maintenance and eventually induction and more widespread utilization of blood-based diagnostics.

總體而言，我們預計 LEQEMBI 在短期內將持續環比成長。我們相信，未來有一些潛在的催化劑可以加速吸收，包括最快明年可能提供靜脈注射維持、用於維持和最終誘導的皮下製劑以及更廣泛地利用基於血液的診斷。

Just to underline how much of a lift this is for physicians, some of you may have noted an opinion piece in JAMA Neurology, dated October 14, that was written by Katherine Possin of UCSF, Jeff Burns at University of Kansas and Brent Forester at Tufts. They talk about the unprecedented time of advances. But equally, they say the challenge and the importance of translating scientific advances in diagnostics, treatment, and care into practice in a timely and equitable manner cannot be overemphasized. Innovation at the clinic health care system and policy levels is necessary to equitably translate advances at scale.

為了強調這對醫生來說有多大的幫助，你們中的一些人可能已經注意到10 月14 日發表在《JAMA Neurology》上的一篇評論文章，該文章由UCSF 的Katherine Possin、堪薩斯大學的Jeff Burns 和塔夫茨大學的Brent Forester 撰寫。他們談論前所未有的進步時代。但同樣，他們表示，及時、公平地將診斷、治療和護理方面的科學進步轉化為實踐所面臨的挑戰和重要性怎麼強調也不為過。診所醫療保健系統和政策層面的創新對於公平地大規模轉化進步是必要的。

So we continue to believe that this is going to be an important market. But again, we don't believe that we have a demand issue. It is just taking the health care system time to actually adapt to treating this number of patients.

因此，我們仍然相信這將是一個重要的市場。但同樣，我們不認為有需求問題。醫療保健系統只是需要時間來真正適應治療這麼多患者。

Turning to SKYCLARYS. We saw increased demand globally as we broadened our footprint, particularly in Europe. SKYCLARYS is now generating revenue from both commercial and other paid mechanisms in 15 markets outside the US. This includes a number of countries in the EU, where we are seeing increased demand quarter-over-quarter.

轉向 SKYCLARYS。隨著我們擴大業務範圍，我們看到全球需求不斷增加，特別是在歐洲。 SKYCLARYS 目前在美國以外的 15 個市場透過商業和其他付費機制產生收入。這包括歐盟的許多國家，我們看到這些國家的需求逐季增加。

Now, at this point, I'd like to say there is a difference between how we generate revenue in the US and how we're seeing demand develop in Europe. In the US, our revenue is rising at the rate we find patients. In Europe, we are actually already out there commercializing the product. And we have a number of early access programs in place. But the strategy for a lot of products in Europe is to get patients on board while you're negotiating with governments to get reimbursement. And at some point, then the governments reimburse those patients and you have an immediate population of patients ready to go because they are already on treatment.

現在，我想說的是，我們在美國創造收入的方式與我們看到歐洲需求發展的方式之間存在差異。在美國，我們的收入隨著找到患者的速度而成長。在歐洲，我們實際上已經將該產品商業化。我們已經制定了許多搶先體驗計劃。但歐洲許多產品的策略是在與政府談判以獲得報銷時讓患者參與其中。到了某個時候，政府就會向這些患者提供補償，這樣就有一群患者可以立即出發，因為他們已經在接受治療。

So when you're looking at the progression quarter-on-quarter, the ex-US piece is not going to be a reflection of growing demand, but it's going to be a reflection of at what point in time do we get reimbursement for governments. But I can tell you that we are adding patients every day, every week in Europe at a pace that has exceeded our expectations.

因此，當您查看季度環比的進展時，美國以外的部分不會反映需求的成長，而是反映我們在什麼時間點獲得政府的補償。但我可以告訴你，我們在歐洲每天、每週都在增加患者，速度超出了我們的預期。

Now, we are looking to expand access to more patients, and there are now 11 regulatory filings that have been submitted globally. So we're looking now beyond the US and Europe, and they could start generating revenue as soon as next year.

現在，我們正在尋求擴大對更多患者的覆蓋範圍，目前已在全球範圍內提交了 11 份監管文件。因此，我們現在將目光投向美國和歐洲以外的地區，他們最快明年就可以開始產生收入。

ZURZUVAE continues to outperform our expectations commercially in the US where we saw $22 million of revenue in the third quarter, and that's an increase of 49% over the second quarter, driven in part by a 40% increase in patients this quarter. I think the team has done an outstanding job with this launch.

ZURZUVAE 在美國的商業表現持續超出我們的預期，第三季營收為 2,200 萬美元，比第二季成長 49%，部分原因是本季患者數量增加 40%。我認為團隊在這次發布中做得非常出色。

In all of the cases we've been talking about, LEQEMBI, SKYCLARYS, and ZURZUVAE. I'd just remind everybody that these are not pre-existing markets. We are building these markets in each case. And that always takes longer than having incremental innovation where you go in and you just are looking to take some market share from a pre-existing market.

在我們討論的所有案例中，LEQEMBI、SKYCLARYS 和 ZURZUVAE。我只是提醒大家，這些並不是預先存在的市場。我們正在針對每種情況建立這些市場。這總是比你進入的漸進式創新需要更長的時間，而你只是想從現有市場中奪取一些市場份額。

So if we could change the slide, Steve. Our goal is really for sustainable growth. And the short-term and there's medium-term growth. When I came to the company, I had really three major objectives. One is to put Biogen back onto a sustainable growth pattern for revenue, to build a pipeline that can sustain that growth for Biogen well into the 2030s, and also to build a pipeline of leaders who will take this company to even more success in the 2030s.

所以如果我們可以改變幻燈片的話，史蒂夫。我們的目標確實是永續成長。短期和中期增長。當我來到公司時，我確實有三個主要目標。一是讓百健(Biogen) 重新回到可持續的收入成長模式，建立一個能夠在2030 年代維持百健(Biogen) 成長的管道，並建立一個領導者管道，帶領該公司在2030 年代取得更大的成功。

So as we look at the pipeline, I have to say, I think we are very excited about what we see emerging. Again, we are Biogen, we don't do incremental innovation. But I think there are some really interesting products that we feel very good about because unlike a lot of products in the past with Biogen, where we go into Phase 3, and we don't really know whether they're going to work. I think we've seen an awful lot in biomarkers, in data and other indications that suggest there's a -- we have a growing conviction in these assets.

因此，當我們審視管道時，我不得不說，我認為我們對所看到的新興事物感到非常興奮。再說一次，我們是百健（Biogen），我們不做漸進式創新。但我認為有一些非常有趣的產品，我們感覺非常好，因為與百健（Biogen）過去的許多產品不同，我們進入了第三階段，我們真的不知道它們是否會起作用。我認為我們已經在生物標記、數據和其他跡像中看到了大量的證據，表明我們對這些資產越來越有信心。

So BIIB080, one of the things that excites me is that although this is an intrathecal as Priya will say, we recruited early on this one and were finished recruiting. And to me, as someone who's had commercial experience over 35 years, when I see a clinical trial recruiting early, particularly in a competitive space where they're existing therapies, that augurs well for the product downstream.

因此，BIIB080，令我興奮的事情之一是，雖然這是一種鞘內注射，正如 Priya 所說，但我們很早就招募了這一患者，並且已經完成了招募。對我來說，作為一個擁有超過 35 年商業經驗的人，當我看到臨床試驗早期招募時，特別是在現有療法的競爭領域，這對下游產品來說是個好兆頭。

Dapirolizumab, we saw positive Phase 3 results, and I'd like to congratulate Priya because Priya had already thought about this and it's worked with UCB and there's actually a Phase 3 protocol ready to go. And so we'll be starting Phase 3 very soon.

Dapirolizumab，我們看到了積極的 3 期結果，我要祝賀 Priya，因為 Priya 已經考慮過這個問題，並且它正在與 UCB 合作，實際上 3 期方案已經準備就緒。所以我們很快就會開始第三階段。

Lupus is an area of huge unmet need, and we have not only dapi, but we have litifilimab in two indications. And behind that, we have also felzartamab actually in lupus nephritis.

狼瘡是一個巨大的未滿足需求的領域，我們不僅有 dapi，還有兩種適應症的 litifilimab。除此之外，我們還有 felzartamab 實際上用於治療狼瘡性腎炎。

In felza, we had some very encouraging data at San Diego in IgAN, and we've had breakthrough status on AMR. This is a game changer for us in terms of our pipeline because, again, here, we've got Phase 2 data that look very compelling. We all know that there are no guarantees in pipeline development. But at least we have, I think, reason to believe that these products could come to market and make a big difference.

在 felza，我們在聖地牙哥的 IgAN 中獲得了一些非常令人鼓舞的數據，並且我們在 AMR 方面取得了突破性進展。就我們的管道而言，這對我們來說是一個遊戲規則改變者，因為我們再次獲得了看起來非常引人注目的第二階段數據。我們都知道管道開發沒有任何保證。但我認為，至少我們有理由相信這些產品可以進入市場並產生巨大的影響。

And as we start to look at the peak revenue for each of these products, the cumulative of all of these, if they all actually made it to market and got approved, have peak sales cumulatively of about $14 billion. And when you consider that our pharma business today is about $7.5 billion, this late-stage pipeline could really transform Biogen over the longer term.

當我們開始觀察每種產品的峰值收入時，如果所有這些產品實際上都進入市場並獲得批准，那麼所有這些產品的峰值銷售額累計約為 140 億美元。當你考慮到我們今天的製藥業務約為 75 億美元時，從長遠來看，這條後期管道確實可以改變 Biogen。

But I shouldn't really be talking about pipeline. The real expert is Priya. So with that, I'm going to turn it over to Dr. Singhal.

但我真的不應該談論管道。真正的專家是Priya。因此，我將把它交給 Singhal 博士。

Thank you, Chris. Over the last two years, we have focused heavily on augmenting our pipeline, as Chris noted, with an eye towards transforming innovation into novel and impactful medicines. As a result, I believe our current pipeline has several programs that are both supported by encouraging clinical data and have the potential to deliver meaningful value to patients. This includes dapi in SLE, litafilimab in both SLE and CLE, felzartamab in multiple immune-mediated diseases, and our tau ASO BIIB080 in Alzheimer's, as Chris suggested.

謝謝你，克里斯。正如克里斯指出的那樣，在過去的兩年裡，我們專注於擴大我們的產品線，並著眼於將創新轉化為新穎且有影響力的藥物。因此，我相信我們目前的管道有幾個項目，這些項目都得到了令人鼓舞的臨床數據的支持，並且有潛力為患者提供有意義的價值。正如 Chris 所建議的，這包括治療 SLE 的 dapi、治療 SLE 和 CLE 的 litafilimab、治療多種免疫介導疾病的 felzartamab 以及治療阿茲海默症的 tau ASO BIIB080。

While advancing these programs remains our top priority, we are also working to implement acceleration strategies across the broader portfolio to expedite decision-making while continuing to focus on execution. An important example of this is BIIB080, where we recently completed enrollment in the amended Phase 2 trial design and now expect a readout in 2026.

雖然推進這些計劃仍然是我們的首要任務，但我們也致力於在更廣泛的投資組合中實施加速策略，以加快決策速度，同時繼續專注於執行。 BIIB080 就是一個重要的例子，我們最近完成了修訂後的 2 期試驗設計的註冊，現在預計將於 2026 年公佈結果。

Additionally, with the positive Phase 3 results last month, we are moving very quickly with our collaboration partner, UCB, to initiate a second Phase 3 study for dapi in SLE this year. We are also implementing innovative new clinical development strategies to enhance clinical execution and accelerate cycle times. This includes initiatives like using AI to help optimize clinical trial participation and site selection.

此外，憑藉上個月積極的 3 期結果，我們正在與合作夥伴 UCB 快速合作，今年啟動 dapi 治療 SLE 的第二項 3 期研究。我們也正在實施創新的新臨床開發策略，以增強臨床執行並縮短週期時間。這包括使用人工智慧來幫助優化臨床試驗參與和地點選擇等措施。

In parallel to these efforts and aligned with our ambition of continuing to build the pipeline, we are working also with our research and corporate development colleagues to evaluate external innovation opportunities across the development stage and several indications. Overall, we believe that through these objectives, we have the opportunity to execute on a meaningful opportunity that Chris has laid out for Biogen.

在這些努力的同時，並與我們繼續建造管道的雄心相一致，我們也與我們的研究和企業開發同事合作，評估整個開發階段和幾個適應症的外部創新機會。總的來說，我們相信透過這些目標，我們有機會執行克里斯為百健（Biogen）提出的有意義的機會。

Turning to the quarter. I would like to begin with Alzheimer's, where we are working with Eisai to continue generating important insights on LEQEMBI in early AD. This includes areas like long-term treatment effect and real-world evidence, such as that presented at CTAD, but importantly, we are also working to provide optionality for patients.

轉向季度。我想從阿茲海默症開始，我們正在與衛材合作，繼續對 AD 早期的 LEQEMBI 產生重要的見解。這包括長期治療效果和現實世界證據等領域，例如在 CTAD 上提出的證據，但重要的是，我們也致力於為患者提供選擇。

Encouraged by data showing expanded benefit with continued LEQEMBI treatment and beyond just the removal of plaques, we continue to pursue maintenance storing options. We expect regulatory decisions on maintenance dosing for both the IV and the subcutaneous auto-injector next year in 2025.

數據顯示，持續的 LEQEMBI 治療不僅能去除斑塊，還能帶來更大的益處，這讓我們深受鼓舞，因此我們繼續尋求維護儲存選項。我們預計明年 2025 年將做出靜脈注射和皮下自動注射器維持劑量的監管決定。

Furthermore, the AHEAD 3-45 study, evaluating the ability of LEQEMBI to prevent or delay Alzheimer's in preclinical or presymptomatic AD enrolled well, and we just completed enrollment this month in October. I look forward to us providing updates as this trial advances.

此外，AHEAD 3-45 研究評估了 LEQEMBI 在臨床前或症狀前 AD 中預防或延遲阿茲海默症的能力，該研究的入組情況良好，我們於 10 月剛完成入組。我期待著我們隨著試驗的進展提供最新資訊。

We are also working to expand our leadership by advancing novel treatment approaches, including shuttles across different disease states and targets such as tau with BIIB080.

我們也致力於透過推進新的治療方法來擴大我們的領導地位，包括跨越不同疾病狀態和目標的穿梭，例如使用 BIIB080 進行 tau 蛋白治療。

Moving to immunology. We believe we are building an industry-leading late-stage pipeline comprised of programs with established proof of concept. These programs cover a range of immune-mediated diseases that are characterized by significant unmet need. This includes our recent acquisition of felzartamab, where we expect to initiate three Phase 3 studies next year in AMR, IgAN, and PMN while continuing to evaluate other indications where this mechanism of action may be relevant.

轉向免疫學。我們相信，我們正在建立一個領先業界的後期管道，其中包括具有已建立的概念驗證的項目。這些計劃涵蓋了一系列免疫介導的疾病，其特點是需求嚴重未被滿足。這包括我們最近收購的 felzartamab，我們預計明年將啟動針對 AMR、IgAN 和 PMN 的三項 3 期研究，同時繼續評估與此作用機制可能相關的其他適應症。

Additionally, we have multiple programs in SLE where it is estimated that over 3 million individuals worldwide are affected and current standard of care are associated with suboptimal efficacy and various treatment-related toxicities, leading to lasting negative consequences such as organ damage. SLE is also the number one cause of death in women aged 15 to 24 in the US and treatment options for before, during, and after pregnancy are limited due to safety concerns and contraindications for most common therapies.

此外，我們在 SLE 方面有多個項目，估計全球有超過 300 萬人受到影響，而目前的護理標準與次優療效和各種與治療相關的毒性有關，導致器官損傷等持久的負面後果。 SLE 也是美國 15 至 24 歲女性的第一大死因，由於安全問題和大多數常見療法的禁忌症，懷孕前、懷孕期間和懷孕後的治療選擇有限。

Underscoring the potential of our immunology pipeline, we are pleased to report that the Phase 3 study of dapi plus standard of care met the primary endpoint, showing a statistically significant greater improvement in disease activity as assessed by the BICLA endpoint at 48 weeks versus placebo plus standard of care. Importantly, we also saw clinical improvements on key secondary endpoints assessing disease activity and flare prevention, two areas that represent key treatment goals for the management of SLE.

我們很高興地報告，dapi 加標準護理的3 期研究達到了主要終點，表明與安慰劑加相比，48 週時BICLA 終點評估的疾病活動性有統計學意義的更大改善，這突顯了我們免疫學管道的潛力。重要的是，我們也看到了評估疾病活動性和耀斑預防的關鍵次要終點的臨床改善，這兩個領域代表了 SLE 管理的關鍵治療目標。

Following the prior Phase 2 study, Biogen, along with our collaboration partner, UCB, spent time analyzing the results in an attempt to design and derisk a Phase 3 study and demonstrate a potential treatment effect. These learnings, combined with our understanding of the underlying disease biology inform the design of the Phase 3 study which included updated screening criteria to ensure patients had active disease in need of a biologic therapy on top of standard of care.

在先前的 2 期研究之後，Biogen 與我們的合作夥伴 UCB 一起花時間分析結果，試圖設計 3 期研究並消除風險，並展示潛在的治療效果。這些知識與我們對潛在疾病生物學的理解相結合，為第三階段研究的設計提供了信息，其中包括更新的篩檢標準，以確保患有活動性疾病的患者在標準護理的基礎上需要生物治療。

The success of this approach is punctuated by the fact that dapi is only the third molecule to show positive Phase 3 results in a global study in SLE over the last 20 years. We look forward to presenting detailed results from this Phase 3 study as a late breaker at the ACR annual meeting next month, and together with UCB, expect to initiate the second Phase 3 study this year.

dapi 是過去 20 年 SLE 全球研究中第三個顯示出正向 3 期結果的分子，這一事實進一步證明了這種方法的成功。我們期待在下個月的 ACR 年會上公佈這項 3 期研究的詳細結果，作為最後的突破性進展，並與 UCB 一起，預計今年啟動第二項 3 期研究。

Turning to SMA. Our priority has always been on continuing to improve outcomes for patients. We were pleased to present detailed results from the DEVOTE study evaluating the investigational higher-dose regimen of nusinersen at the World Muscle Society meeting earlier this month. The higher dose regimen consists of two 50 milligram loading doses followed by 28 milligrams maintenance doses every four months.

轉向 SMA。我們的首要任務始終是持續改善患者的治療結果。我們很高興在本月稍早的世界肌肉協會會議上展示 DEVOTE 研究的詳細結果，該研究評估了 nusinersen 的高劑量治療方案。較高劑量方案包括兩次 50 毫克負荷劑量，然後每四個月一次 28 毫克維持劑量。

This regimen of high dose delivers more drug in the first administration than the entire two-month loading phase of the approved SPINRAZA 12-milligram regimen. Consistent with the more rapid loading regimen, higher-dose nusinersen, slowed neurodegeneration faster than SPINRAZA 12 milligrams as measured by neurofilament at day 64, an objective biomarker.

這種高劑量方案在第一次給藥時釋放的藥物量比已批准的 SPINRAZA 12 毫克方案的整個兩個月負荷階段還要多。與更快速的負荷方案一致，根據第 64 天神經絲（一種客觀生物標記）的測量，更高劑量的 nusinersen 比 SPINRAZA 12 毫克更能更快地減緩神經變性。

The pivotal infantile onset cohort in Part B of DEVOTE met the primary endpoint of change from baseline to six months in the CHOP INTEND compared to the pre-specified matched sham group, demonstrating a clinically and statistically significant improvement. We also observed trends in reduced risk of death or permanent ventilation versus both sham control and the currently approved regimen.

與預先指定的匹配假手術組相比，DEVOTE B 部分中的關鍵嬰兒發病隊列在 CHOP INTEND 中達到了從基線到六個月變化的主要終點，證明了臨床和統計學上的顯著改善。我們也觀察到與假手術對照組和目前核准的治療方案相比，死亡或永久通氣風險降低的趨勢。

In addition, we shared initial results from the open-label Part C portion of the study with participants aged 4 to 65, transitioning from SPINRAZA 12 milligrams after an average of nearly four years on treatment. This group showed improvement in motor function after transitioning to higher dose. These are exciting results as we seek to help patients currently on disease-modifying therapies.

此外，我們與 4 至 65 歲的參與者分享了該研究開放標籤 C 部分的初步結果，這些參與者在平均治療近四年後從 SPINRAZA 12 毫克過渡。該組在過渡到更高劑量後表現出運動功能的改善。當我們尋求幫助目前正在接受疾病修飾治療的患者時，這些都是令人興奮的結果。

Importantly, the high dose regimen was generally well tolerated and showed a safety profile similar to the approved 12-milligram regimen. We believe these results highlight the unique potential of SPINRAZA to help address remaining unmet need in individuals with SMA, and we aim to submit global regulatory filings later this year.

重要的是，高劑量方案通常具有良好的耐受性，並且顯示出與已批准的 12 毫克方案相似的安全性。我們相信這些結果突顯了 SPINRAZA 的獨特潛力，可以幫助解決 SMA 患者未滿足的需求，我們的目標是在今年稍後提交全球監管文件。

In conclusion, this past quarter, I believe we continue to execute well and achieved several important development milestones that highlight the potential of our pipeline to deliver meaningful new therapies to patients. In addition to late-stage readouts in lupus and SMA, we also submitted ex US filings for zuranolone and PPD and obtained approvals for SKYCLARYS and QALSODY in Switzerland and China, respectively. We also presented new data insights across multiple disease areas, at multiple medical meetings, including Alzheimer's, neuromuscular, and renal disease.

總而言之，在過去的這個季度，我相信我們繼續表現良好，並實現了幾個重要的發展里程碑，這些里程碑凸顯了我們的管道為患者提供有意義的新療法的潛力。除了狼瘡和 SMA 的後期讀數外，我們還提交了 zuranolone 和 PPD 在美國的申請，並分別在瑞士和中國獲得了 SKYCLARYS 和 QALSODY 的批准。我們也在多個醫學會議上展示了多個疾病領域的新數據見解，包括阿茲海默症、神經肌肉疾病和腎臟疾病。

Today, we believe that the pipeline is well positioned to deliver a regular cadence of pivotal readouts and potential launches. We continue to aspire to bring transformative medicines to patients' lives while we deliver on Biogen's objective of achieving sustainable growth.

今天，我們相信該管道處於有利位置，可以定期提供關鍵讀數和潛在發布。我們繼續渴望為患者的生活帶來變革性藥物，同時實現百健 (Biogen) 實現可持續成長的目標。

Furthermore, I believe that the same core capabilities and deep disease area expertise that enabled us to reshape our current pipeline and establish leadership foothold in areas like Alzheimer's, immunology and rare disease also uniquely position us to evaluate external innovation as we look for opportunities to augment our pipeline.

此外，我相信，同樣的核心能力和深厚的疾病領域專業知識使我們能夠重塑當前的產品線並在阿茲海默症、免疫學和罕見疾病等領域建立領導地位，也使我們在尋找增強機會的同時評估外部創新。

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

至此，我現在想將電話轉交給麥克，以了解最新的財務狀況。

Thank you, Priya, and good morning to everyone. I'd like to provide some color on our third quarter results and all the comparisons that you'll hear me make are versus the third quarter of 2023, unless you hear me note otherwise.

謝謝你，Priya，祝大家早安。我想對我們第三季的業績提供一些說明，並且您將聽到我所做的所有比較都是與 2023 年第三季的比較，除非您聽到我另有說明。

Total revenue for the quarter was $2.5 billion. Both total revenue and core pharmaceutical revenue were down 3%. Non-GAAP diluted EPS was $4.08 and that's down 6%. In just a moment, I'll provide some additional detail on some key dynamics to note from the third quarter.

該季度總收入為 25 億美元。總收入和核心藥品收入均下降 3%。非 GAAP 攤薄後每股收益為 4.08 美元，下降 6%。稍後，我將提供有關第三季需要注意的一些關鍵動態的更多詳細資訊。

Non-GAAP operating income increased 4% versus the third quarter of 2023 as we continue to benefit from our R&D prioritization and Fit for Growth initiatives. We are pleased to again be raising our full year 2024 guidance range. And in just a few moments, I'll provide some additional color on our raised guidance range for 2024.

與 2023 年第三季相比，非 GAAP 營業收入成長了 4%，因為我們繼續受益於我們的研發優先順序和適合成長計畫。我們很高興再次上調 2024 年全年指導範圍。稍後，我將就我們上調的 2024 年指導範圍提供一些額外的資訊。

Few comments on revenue for the third quarter. Our MS product revenue declined by approximately 9%, and that was driven primarily by competitive dynamics in the space, along with some channel dynamics. Importantly, we announced last week that the European Patent Office upheld the validity of Biogen's TECFIDERA-related patent covering DMF dosing, which expires in February of 2028. We are pleased with the decision. However, generics are challenging this patent, and we do anticipate further challenges.

關於第三季營收的評論很少。我們的 MS 產品收入下降了約 9%，這主要是由該領域的競爭動態以及一些通路動態推動的。重要的是，我們上週宣布歐洲專利局維持百健 (Biogen) 涉及 DMF 劑量的 TECFIDERA 相關專利的有效性，該專利將於 2028 年 2 月到期。然而，仿製藥正在挑戰這項專利，我們預計還會出現進一步的挑戰。

TYSABRI has seen impacts from a biosimilar entrant in Europe, and although a biosimilar is not yet launched in the US, we continue to see increasing competition in the high-efficacy class. Next, our rare disease franchise produced revenue of $495 million, and that represents growth of 10%.

TYSABRI 已經看到了歐洲生物相似藥進入者的影響，儘管生物相似藥尚未在美國上市，但我們繼續看到高效類別的競爭日益激烈。接下來，我們的罕見疾病特許經營收入達到 4.95 億美元，成長了 10%。

The SKYCLARYS launch continues to progress in the US, where revenue of $82 million increased 8% from the second quarter, and that was driven by increased demand. SKYCLARYS is now generating revenue in 15 countries outside the US with third quarter global revenue of $102 million. This was up modestly from the second quarter, driven by an increase in demand, and that was partially offset by some pricing and reimbursement dynamics in some newly launched markets.

SKYCLARYS 在美國的推出繼續取得進展，在需求成長的推動下，美國第二季的營收為 8,200 萬美元，成長了 8%。 SKYCLARYS 目前在美國以外的 15 個國家創造收入，第三季全球收入為 1.02 億美元。在需求成長的推動下，這一數字較第二季略有上升，但部分新推出市場的定價和報銷動態抵消了這一成長。

Global SPINRAZA revenue of $381 million declined $67 million or 15% and that was impacted by the loss of an annual tender in Russia, which resulted in an unfavorable impact of approximately $45 million in the third quarter. It is important to note that this tender which occurs and contributes to revenue only once each year affected Q3 2024 results, but we do not expect further revenue impact for the rest of this year. The global decrease was also impacted by the timing of shipments and some foreign currency. SPINRAZA US revenue was up 2% to $153 million, and we remain encouraged by the performance here.

全球 SPINRAZA 收入為 3.81 億美元，下降了 6,700 萬美元或 15%，這是由於俄羅斯年度招標失敗的影響，導致第三季約 4,500 萬美元的不利影響。值得注意的是，這項招標每年只發生一次並貢獻收入，影響 2024 年第三季的業績，但我們預計今年剩餘時間不會對收入產生進一步影響。全球下降也受到發貨時間和一些外幣的影響。 SPINAZA 美國營收成長 2%，達到 1.53 億美元，我們仍然對這裡的表現感到鼓舞。

ZURZUVAE delivered $22 million of revenue in the quarter, and that's up 49% from the second quarter, and we continue to be encouraged by an increase in demand.

ZURZUVAE 本季實現了 2,200 萬美元的收入，比第二季成長了 49%，需求的成長繼續令我們感到鼓舞。

We again saw sequential growth for LEQEMBI with third quarter global in-market sales booked by Eisai of approximately $67 million, and that's up 66% versus the second quarter. LEQEMBI in-market sales in the US were $39 million, that's up 33% versus the second quarter.

我們再次看到 LEQEMBI 的環比成長，衛材第三季全球市場銷售額約為 6,700 萬美元，比第二季成長 66%。 LEQEMBI 在美國的市場銷售額為 3,900 萬美元，比第二季成長 33%。

And finally, contract manufacturing, royalty, and other revenue was $250 million. That was notably lower year-over-year as expected due to the completion of certain batch commitments in 2023.

最後，合約製造、特許權使用費和其他收入為 2.5 億美元。由於 2023 年某些批次承諾的完成，這一數字明顯低於預期。

Now, I'll turn to a few comments on third quarter expenses. Non-GAAP cost of sales as a percentage of revenue decreased 2 percentage points, and that was driven primarily by product mix, particularly the year-over-year increase in revenue from new product launches and the decrease in contract manufacturing revenue as well as lower idle capacity charges. Non-GAAP R&D expense decreased $48 million as we continue to see benefits from our R&D prioritization initiatives.

現在，我將談談第三季支出的一些評論。非 GAAP 銷售成本佔收入的百分比下降了 2 個百分點，這主要是由產品組合推動的，特別是新產品推出帶來的收入同比增長、合約製造收入的減少以及較低的收入閒置容量費用。由於我們繼續看到研發優先計畫的好處，非 GAAP 研發費用減少了 4,800 萬美元。

Non-GAAP SG&A expense increased 1% in the third quarter as benefits from our Fit for Growth initiative allowed us to absorb most of the $45 million of incremental costs in the third quarter associated with our launches. We continue to believe we can garner $1 billion of gross and $800 million of net savings associated with our Fit for Growth initiative by the end of 2025.

第三季非 GAAP SG&A 費用增加了 1%，因為我們的「適合成長」計畫的收益使我們能夠吸收第三季與我們的產品發布相關的 4,500 萬美元增量成本中的大部分。我們仍然相信，到 2025 年底，我們可以透過 Fit for Growth 計畫實現 10 億美元的總節省和 8 億美元的淨節省。

Non-GAAP EPS was $4.08 in the third quarter. EPS was unfavorably impacted by certain non-operating items, including a decline of approximately $80 million of net interest income on lower cash balances as a result of the Reata and HI-Bio-acquisitions. This was partially offset by some favorable tax items in the quarter, which added about $16 million to our net income.

第三季非 GAAP 每股盈餘為 4.08 美元。每股盈餘受到某些非經營項目的不利影響，包括因收購 Reata 和 HI-Bio 而導致現金餘額減少，導致淨利息收入減少約 8,000 萬美元。這部分被本季的一些優惠稅收項目所抵消，這些稅收項目為我們的淨利潤增加了約 1600 萬美元。

Now, a brief update on our balance sheet. We ended the quarter with $1.7 billion of cash and marketable securities and approximately $4.6 billion of net debt. We were able to generate approximately $901 million of free cash flow, and that was our highest free cash flow since the second quarter of 2021. Third quarter 2024 free cash flow benefited in part from some favorable working capital dynamics. We continue to believe that our balance sheet remains strong and provides us the capacity to continue to invest in both internal and external growth opportunities.

現在，簡要更新我們的資產負債表。本季結束時，我們擁有 17 億美元的現金和有價證券，以及約 46 億美元的淨債務。我們能夠產生約 9.01 億美元的自由現金流，這是自 2021 年第二季以來我們最高的自由現金流。我們仍然相信，我們的資產負債表仍然強勁，並使我們有能力繼續投資於內部和外部成長機會。

Turning now to guidance. We're pleased that the business performance year-to-date, again supports raising our full year 2024 non-GAAP diluted EPS guidance range from between $15.75 and $16.25 to a new range of between $16.10 and $16.60. This new range reflects expected growth of approximately 11% at the midpoint of the range compared to full year 2023.

現在轉向指導。我們很高興今年迄今的業務表現再次支持將 2024 年全年非 GAAP 攤薄每股收益指引範圍從 15.75 美元至 16.25 美元提高到 16.10 美元至 16.60 美元的新範圍。這一新範圍反映出與 2023 年全年相比，該範圍中點的預期增長約為 11%。

I'd like to highlight a few of the key assumptions relevant to this guidance. First, on the top line, we continue to expect that our total revenue will decline by a low single-digit percentage. And as we've communicated throughout the year, we expect to continue to ramp investment behind our new product launches and key R&D programs which includes felzartamab following our acquisition of HI-Bio.

我想強調一些與本指南相關的關鍵假設。首先，在營收方面，我們仍然預期我們的總收入將出現較低的個位數百分比下降。正如我們全年所傳達的那樣，我們預計將繼續加大對新產品發布和關鍵研發項目的投資，其中包括收購 HI-Bio 後的 felzartamab。

And lastly, as is typically the case with our business, we expect seasonally higher SG&A spend in the fourth quarter as compared to the rest of the year. I would refer you to this slide as well as our press release for other important guidance assumptions.

最後，正如我們業務的典型情況一樣，我們預計第四季度的 SG&A 支出將高於今年剩餘時間。我建議您參閱這張投影片以及我們的新聞稿，以了解其他重要的指導假設。

In closing, we remain focused on advancing our ongoing product launches and key areas of our late-stage pipeline. We believe our efforts in these areas will help position Biogen for long-term sustainable growth, which continues to be our number one goal.

最後，我們仍然專注於推進我們正在進行的產品發布和後期管道的關鍵領域。我們相信，我們在這些領域的努力將有助於百健（Biogen）實現長期永續成長，這仍然是我們的首要目標。

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

至此，我們將開始提問。

(Operator Instructions) Brian Abrahams, RBC Capital Markets.

（操作員指示）Brian Abrahams，RBC 資本市場。

Hey. Good morning. Thanks so much for taking my question. I'm curious on LEQEMBI, when you might expect to see more pull-through from the expanded commercial efforts, whether you're starting to see any of those signals in October. And you mentioned as well the potential for some other commercial acceleration strategies in your prepared remarks. Can you maybe expand on that a little bit more and characterize your overall alignment with Eisai on the commercial plans? Thanks.

嘿。早安.非常感謝您提出我的問題。我對 LEQEMBI 很好奇，無論你是否在 10 月開始看到這些訊號，你可能會期望看到擴大的商業努力帶來更多的拉動。您在準備好的發言中也提到了其他一些商業加速策略的潛力。您能否進一步擴展一下這一點，並描述一下您與衛材在商業計劃上的整體一致性？謝謝。

Yeah. I'll take the second part of the question, Brian, and then pass it over to Alisha who can give a little more color on the expanded field force. I think we have learned an awful lot really in the year since we launched the product. I mean, the product launch really started really last fall, I mean we had to get all of the commercial team in place, but we also needed clarity around things like reimbursement of the PET scans. So for us, I think this is about the anniversary really of the launch.

是的。布萊恩，我將回答問題的第二部分，然後將其交給艾莉莎，她可以為擴大的現場力量提供更多的資訊。我認為自從推出該產品以來，我們在這一年確實學到了很多東西。我的意思是，產品發布實際上是從去年秋天開始的，我的意思是我們必須讓所有商業團隊就位，但我們還需要澄清諸如 PET 掃描報銷之類的事情。所以對我們來說，我認為這是真正的發布週年紀念日。

And there are a lot of things that we are now understanding the time it can take for IDNs to really get their protocols in place and the care pathways. But there are also a number of things like who's the right patient. And we have also an awful lot more data coming along. We're going to have the subcutaneous formulation, hopefully, next year for maintenance, the IV for maintenance sometime next year. And so it seems opportune for the two partners now to come together and just review what's working well and what could we be doing more? So we'd probably be able to give you some more color on that.

我們現在正在了解 IDN 真正落實其協議和護理途徑所需的時間。但還有很多事情，例如誰是合適的病人。我們也收到了更多的數據。希望明年我們將採用皮下製劑維持，明年某個時候採用靜脈注射維持。因此，現在兩個合作夥伴走在一起似乎是合適的時機，回顧一下哪些方面運作良好，哪些方面我們還可以做得更多？因此，我們可能可以為您提供更多資訊。

I would say the teams are working very well together. We both understand that this is a very complicated launch. I think more complicated than most that I've certainly seen, I think, most people have seen. And yet, we do see a lot of physicians, again, who are really putting an awful lot of work in to make all of this happen. To triage the patients as to who's really the right patient, a high percentage of patients coming into the neurologists are not eligible for treatment. Then organizing the PET scans and the lumbar punctures, the MRIs and the infusion beds.

我想說，這些團隊合作得很好。我們都知道這是一次非常複雜的發布。我認為比我所見過的大多數人都更複雜，我認為大多數人都見過。然而，我們確實再次看到許多醫生為實現這一切付出了巨大的努力。為了對患者進行分類，以確定誰是真正合適的患者，大部分到神經科就診的患者不符合接受治療的條件。然後組織 PET 掃描、腰椎穿刺、核磁共振成像和輸液床。

So we've seen an awful lot of real effort out there in the marketplace, and we add prescribers every week and we see more sales every week. And so I think that's the way it's going to progress probably until we get the subcutaneous for induction. I think that could be quite a game changer. And again, more use of the blood-based diagnostics in place of the PET scan. Both of those would, I think, dramatically reduce the workload of physicians.

因此，我們在市場上看到了非常多的實際努力，我們每週都會增加處方者，並且每週都會看到更多的銷售。所以我認為這可能是進展的方式，直到我們進行皮下誘導。我認為這可能會徹底改變遊戲規則。再次，更多地使用基於血液的診斷來代替 PET 掃描。我認為，這兩者都會大大減少醫生的工作量。

But Alisha, maybe you can talk about the expanded field force and anything else you think might be helpful.

但是艾莉莎，也許你可以談談擴大的現場部隊以及任何你認為可能有幫助的事情。

Yeah. Thank you, Chris, and thank you for the question, Brian. As all of you have seen in Q3, we did have steady launch progress as we've seen in prior quarters. And that's including in the new number of patients. Also encouraging what you don't see in the trends that we're able to see is the total prescribers writing and actually in Q3 the new number of writers increased by 40% versus Q2. So you are seeing these physicians come on every single week, IDNs expanding every single week as well. However, at the end of the day, just like in the beginning of the launch and even today, fast forward after we've been out in the field for a while, what shows up in market research is the key barrier is still these infrastructure challenges, as Chris alluded to.

是的。謝謝你，克里斯，也謝謝你提出的問題，布萊恩。正如大家在第三季所看到的那樣，我們確實取得了穩定的發布進展，正如我們在前幾個季度所看到的那樣。這包括新的患者數量。同樣令人鼓舞的是，您在我們能夠看到的趨勢中看不到的是處方醫生的寫作總數，實際上在第三季度，新的作者數量比第二季度增加了 40%。因此，您會看到這些醫生每週都會來，IDN 也每週都在擴大。然而，最終，就像發布之初一樣，甚至今天，在我們進入該領域一段時間後，市場研究中顯示的關鍵障礙仍然是這些基礎設施正如克里斯所提到的，挑戰。

However, now with the new Biogen team on Board, we're also able to confirm that, especially with physicians who haven't written yet, that is really one of their main concerns. Our second concern, of course, is still ARIA, even though it's not as big of a concern as it was prior. However, once they work through some patients and they work out their protocols, you do see that alleviate.

然而，現在有了新的百健（Biogen）團隊的加入，我們也能夠確認，特別是對於尚未撰寫文章的醫生來說，這確實是他們主要關心的問題之一。當然，我們的第二個問題仍然是 ARIA，儘管它不像之前那麼嚴重。然而，一旦他們對一些患者進行了治療並製定了治療方案，你就會發現情況有所緩解。

However, we now have our full field force out there. And as a reminder, we were very intentional as an organization as to who to hire. We were in a little bit of a luxury situation at the time. When we posted these roles, we had over 1,000 applicants and we only had a little over 25 roles that we had posted.

然而，我們現在擁有完整的現場部隊。提醒一下，作為一個組織，我們對於僱用誰是非常有意的。當時我們的處境有點奢侈。當我們發布這些職位時，有超過 1,000 名申請人，但我們發布的職位僅略多於 25 個。

So we were really able to pick those individuals who either had history in Alzheimer's disease or a history in these territories and already had built in relationships. And so now the teams have been out there for several weeks. We are starting to see in the offices specifically where Biogen has overlaid with Eisai, where we are engaging, we do see a little bit more accelerated growth than what you do see in the rest of the nation. We're able to reach more targets and also, doors are opening up a little more easily for us because, again, those representatives did have prior relationships with physicians.

因此，我們確實能夠挑選出那些有阿茲海默症病史或在這些地區有病史並且已經建立了關係的人。現在這些團隊已經在那裡待了幾個星期了。我們開始在百健 (Biogen) 與衛材 (Eisai) 重疊的辦公室中看到，在我們參與的地方，我們確實看到了比在全國其他地方看到的更快的增長。我們能夠實現更多目標，而且大門也更容易為我們敞開，因為這些代表之前確實與醫生有過關係。

And so in the longer term, we obviously are going to continue with doing frequency in depth. But at the end of the day, for example, we can say in the Pacific Northwest, we had a rep that's been had a relationship that actually prior with MS for 17 years, they're able to help the physician right away. Another physician in the Southeast, they had a relationship over 20 years, they were able to unlock over 30 patients, I think, in less than a two-week time period. So the relationships we've seen has mattered. Also the history has mattered, and we are starting to see some acceleration, even though they've only been out there fully for about a month or so.

因此，從長遠來看，我們顯然將繼續深入研究頻率。但歸根結底，例如，我們可以說，在太平洋西北地區，我們有一位代表，他實際上與 MS 有著 17 年的關係，他們能夠立即為醫生提供幫助。東南部的另一位醫生，他們有超過 20 年的合作關係，我認為他們能夠在不到兩週的時間內解鎖 30 多名患者。所以我們所看到的關係很重要。此外，歷史也很重要，我們開始看到一些加速，儘管它們只完全存在了大約一個月左右。

Thank you, Alisha. Next question, please.

謝謝你，艾莉莎。請下一個問題。

Phil Nadeau, TD Cowen.

菲爾·納多，TD·考恩。

Good morning. Thanks for taking our question. Chris, you've referenced the subcutaneous formulation a couple of times already this morning. Could you give us a bit more of an update on the status of the subcu filings both for maintenance as well as for induction? Thanks.

早安.感謝您提出我們的問題。克里斯，今天早上你已經多次提到了皮下注射製劑。您能否向我們提供有關維護和導入的 subcu 備案狀態的更多更新資訊？謝謝。

Sure. I'll turn that over to Priya.

當然。我會把它交給 Priya。

Yes. Thank you for that question. So we remain on top to really complete our subcutaneous maintenance filing as Eisai has indicated, and we expect that to be imminent. And then moving on to the initiation, we are working to generate the data, analyze the data. This is part of the Clarity open-label extension study in the subcutaneous sub-study. And as Eisai has indicated, we remain on track to expect a regulatory outcome on subcutaneous initiation therapy by Q1 of 2026 calendar year.

是的。謝謝你提出這個問題。因此，正如衛材所表示的那樣，我們仍然處於真正完成皮下維護備案的領先地位，我們預計這很快就會完成。然後開始，我們正在努力產生數據、分析數據。這是皮下子研究中 Clarity 開放標籤擴展研究的一部分。正如衛材所指出的，我們仍有望在 2026 年第一季獲得皮下起始治療的監管結果。

Thank you, Priya. Next question please, operator.

謝謝你，普里亞。接線員，請下一個問題。

Marc Goodman, Leerink.

馬克‧古德曼，萊林克。

Yes. Could you comment a little bit more on SKYCLARYS on US. There was a comment in the opening remarks about pricing and reimbursement dynamics. And if you could just give us a little more color there to the challenges. Thank you.

是的。您能對美國的 SKYCLARYS 發表更多評論嗎？開場白中有一條關於定價和報銷動態的評論。如果你能為我們的挑戰提供更多的色彩的話。謝謝。

Yeah. So as you know, you get approval in Europe, but then you have to go country by country to negotiate for reimbursement. And basically, what we are already doing is seeing physicians, and we're getting patients on treatment. But the actual revenue generation of those patients varies by countries. So there are some countries, for instance, where you can charge for an early access program. There are countries where you can't, there are some countries where you can get reimbursement much earlier than other European countries. So we are in that process.

是的。如您所知，您在歐洲獲得了批准，但隨後您必須逐個國家進行報銷談判。基本上，我們已經在做的就是去看醫生，並讓病人接受治療。但這些患者的實際收入因國家而異。例如，在某些國家/地區，您可以對搶先體驗計劃收費。有些國家你不能，有些國家你可以比其他歐洲國家更早獲得報銷。所以我們正處於這個過程中。

What we have not done is really started the revenue generation -- sorry, the patient demand generation with reimbursement. We are active in all countries and signing up patients. And so we're tracking patient numbers, which are growing considerably every month. What you will see in the quarterly revenue numbers is when those patients convert to revenue-generating patients. And that is, by definition, going to be a little lumpy because the patient demand is actually in advance of when we generate revenue.

我們還沒有真正開始創造收入——抱歉，病人的需求是透過報銷產生的。我們活躍在所有國家並為患者簽約。因此，我們正在追蹤患者人數，這些人數每個月都在大幅增加。您將在季度收入數據中看到這些患者何時轉化為創收患者。根據定義，這會有點不穩定，因為患者的需求實際上早於我們產生收入的時間。

And on the -- on those programs where you have early access that you can pay for, you have to establish a price. But in some cases, there is a clawback if the reimbursed price is going to be lower than what the prices you're charging. And obviously, as we go into countries and have a better idea where the price point is, we've had to make some adjustments on revenue that we have booked and those programs where we can charge for an EAP. And that's just really a normal process in most launches in Europe.

對於那些可以提前訪問並可以付費的項目，您必須制定價格。但在某些情況下，如果報銷價格低於您收取的價格，則會出現回扣。顯然，當我們進入各個國家並更好地了解價格點時，我們必須對我們預訂的收入以及我們可以收取 EAP 費用的項目進行一些調整。這實際上是歐洲大多數產品發布的正常過程。

Thank you, Chris. Next question, operator.

謝謝你，克里斯。下一個問題，操作員。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Thank you. Good morning. Chris, you spoke to the efforts with regard to the late-stage pipeline in R&D, but you've also noted the lever with regard to business development. Any updated thoughts here as to the strategy for the latter on the forward?

謝謝。早安.克里斯，您談到了研發後期管道方面的努力，但您也注意到了業務發展方面的槓桿。關於後者的前進策略有什麼更新的想法嗎？

Yeah, I mean we're in one of those classic situations in our industry where we've had a legacy portfolio of assets that is facing increased competition. And on the horizon, we see an extremely promising pipeline and how do you bridge across that. And some companies choose to simply wait that out and wait for the arrival of the pipeline. And our business is likely to grow between now and 2028, but I would say that the growth is not necessarily satisfactory for us. So we are looking and continue to look, I spent personally quite a lot of time on this. Are there assets that we could bring in that could enhance our revenue growth in the near term but also that still create value for shareholders.

是的，我的意思是，我們正處於行業中的典型情況之一，我們擁有傳統的資產組合，但面臨著日益激烈的競爭。在地平線上，我們看到了一個非常有前途的管道，以及如何跨越它。有些公司選擇簡單地等待，等待管道的到來。從現在到 2028 年，我們的業務可能會成長，但我想說，這種成長不一定會讓我們滿意。所以我們正在尋找並繼續尋找，我個人在這方面花了很多時間。我們是否可以引入一些資產，既可以提高我們短期內的收入成長，又可以為股東創造價值。

We're not really interested in just buying revenue. If we can buy growth, and we can make a very good return on investment, then we'll do so. But as you know, assets get pretty highly priced as they get close to the market. So you have to do an awful lot of digging and an awful lot of looking, and that's what we are doing. We have a whole team of people that look at both public and private companies. And I think we still have considerable financial capacity. And Mike, you may want to comment on that. But we are active in that, but we are also disciplined fiduciaries of shareholder money. I've always said we get paid to make our shareholders wealthy, not somebody else's shareholders.

我們對僅僅購買收入並不真正感興趣。如果我們能夠購買成長，並且能夠獲得非常好的投資回報，那麼我們就會這樣做。但如您所知，當資產接近市場時，它們的價格就會相當高。所以你必須做大量的挖掘和大量的尋找，這就是我們正在做的。我們有一整個團隊關注上市公司和私人公司。而且我認為我們還是有相當的財力的。麥克，你可能想對此發表評論。但我們在這方面很積極，但我們也是股東資金的紀律受託人。我總是說，我們獲得報酬是為了讓我們的股東變得富有，而不是讓別人的股東變得富有。

Yes. So Salveen, just on capacity, just to give you a frame of reference. We ended the quarter with about $1.7 billion of cash on hand. And when you think about our capital structure, about $6.3 billion in total debt on an EBITDA run rate of about $3.3 billion to $3.4 billion. So it's below 2 times gross, that's a very modest amount. And when you think about capacity, we're pleased with about $2 billion of free cash flow year-to-date, $901 million in the quarter.

是的。 Salveen，只是就能力而言，只是為了給你一個參考框架。本季結束時，我們手頭現金約為 17 億美元。考慮到我們的資本結構，我們的債務總額約為 63 億美元，EBITDA 運作率為 33 億至 34 億美元。所以它低於總量的 2 倍，這是一個非常適中的數量。當你考慮產能時，我們對今年迄今為止約 20 億美元的自由現金流感到滿意，本季為 9.01 億美元。

So with a couple of billion dollars plus of free cash flow per year and less than two turns of gross leverage, you can see over the next couple of years, if you added a reasonable amount of incremental debt at some point in time plus the free cash flow and the cash on hand, there's comfortably $8 billion to $10 billion of capacity that you've got over the next year or two in order to collaborate and transact and look at acquisitions and other things that we can do to help supplement our growth.

因此，憑藉每年數十億美元的自由現金流和不到兩輪的總槓桿率，如果您在某個時間點添加合理數量的增量債務加上自由現金流，您可以在接下來的幾年中看到現金流和手頭現金，在未來一兩年內您將擁有 80 億至 100 億美元的能力，以便進行合作、交易、考慮收購和其他我們可以採取的措施來幫助補充我們的成長。

Thank you, Mike. Next question please, operator.

謝謝你，麥克。接線員，請下一個問題。

Michael Yee, Jefferies.

麥可葉，杰弗里斯。

Thank you. Good morning. We noticed that you completed the enrollment of the AHEAD 3-45 study. And I just wanted to ask Priya, if you could remind us what the timeline would look for that, more specifically, if there is a potential for an interim analysis and/or what that would be based on? My understanding is that these are pretty early presymptomatic patients. Is there an enrichment of the population? And why would you be expecting that this can be positive? Thank you.

謝謝。早安.我們注意到您已完成 AHEAD 3-45 研究的註冊。我只是想問 Priya，您能否提醒我們時間表會尋找什麼，更具體地說，是否有可能進行中期分析和/或基於什麼？我的理解是，這些都是相當早期出現症狀的患者。人口是否富裕了？為什麼你會期望這會是正面的？謝謝。

Thank you, Michael. Yes, we're excited about the fact that AHEAD 3-45 has completed enrollment in October. Just to remind everyone, it's two trials, and one is really looking at early intermediate stages -- patients with early intermediate stages of amyloid and the other is with higher load amyloid. And these are very large trials, so it's about 400 patients in the AHEAD 3, which is the earliest intermediate stage and about 1,000 patients in AHEAD 45 and the timeline, the trials have a 216-week time point.

謝謝你，麥可。是的，我們對 AHEAD 3-45 已於 10 月完成註冊感到興奮。只是提醒大家，這是兩項試驗，一項真正著眼於早期中期階段——澱粉樣蛋白早期中期階段的患者，另一項是澱粉樣蛋白含量較高的患者。這些都是非常大的試驗，因此 AHEAD 3 約有 400 名患者，這是最早的中間階段，AHEAD 45 約有 1,000 名患者，從時間軸來看，試驗有 216 週的時間點。

Having said that, we are continuing in parallel to engage with regulators and look at all options of when these might be ready to read out. So we'll continue to provide more updates, but we're very excited about having completed enrollment, specifically because the data that we've shared from the Clarity study shows that treating early and with patients with low tau or no tau, really, you see a lot of benefits in terms of stabilization and actually even clinical improvement. So it continues to really be a very exciting space for patients to have therapies, and that's why we're very excited about where we are today.

話雖如此，我們正在繼續與監管機構同時進行接觸，並研究何時可以準備好讀出這些內容的所有選項。因此，我們將繼續提供更多更新，但我們對完成註冊感到非常興奮，特別是因為我們從 Clarity 研究中分享的數據表明，儘早治療低 tau 或無 tau 的患者，真的，您會看到在穩定性甚至臨床改善方面有許多好處。因此，對於患者來說，它仍然是一個非常令人興奮的接受治療的空間，這就是為什麼我們對今天的進展感到非常興奮。

Thank you, Priya. Next question, please.

謝謝你，普里亞。請下一個問題。

Umer Raffat, Evercore ISI.

烏默·拉法特，Evercore ISI。

Hi, guys. Thanks for taking my questions. I thought I'll focus on a slightly different topic for a quick second. It does look like there's a very significant amount of R&D investment going into lupus between your dapirolizumab as well as your BDCA molecule and possibly the CD38 as well.

嗨，大家好。感謝您回答我的問題。我想我會暫時專注在一個稍微不同的主題上。看起來確實在達匹羅利珠單抗、BDCA 分子以及可能還有 CD38 之間投入了大量針對狼瘡的研發投資。

And I guess my broader question is this. You hit a Phase 3, which is obviously good news. But separately, we're seeing incredible remission data from some CD19 CAR-Ts, which might even possibly manifest in some CD19 bispecifics as well. So it seems like you have a lot of exposure, not on that area, which is CD19 bispecific. And I guess, how should we weigh by the time you guys do get to this market relative to some of the emerging data from potentially CD19 bispecific or the T cell engagers? Thank you very much.

我想我更廣泛的問題是這樣的。你進入了第三階段，這顯然是個好消息。但另外，我們看到一些 CD19 CAR-T 令人難以置信的緩解數據，這甚至可能也反映在一些 CD19 雙特異性抗體中。所以看起來你有很多曝光，但不是在 CD19 雙特異性區域。我想，當你們真正進入這個市場時，相對於潛在的 CD19 雙特異性或 T 細胞接合者的一些新興數據，我們應該如何權衡？非常感謝。

Thank you, Umer. Yes, we continue to watch the innovation in the space, and it's exciting for patients. But I think when you step back and you think about the potential that dapi can offer, and with the data that we shared and we'll be sharing more data at ACR in a few weeks here, and it is embargoed, we're very excited by what we've seen in this moderate-to-severe population.

謝謝你，烏梅爾。是的，我們將繼續關注該領域的創新，這對患者來說是令人興奮的。但我認為，當你退一步思考 dapi 可以提供的潛力時，透過我們共享的數據，我們將在幾週內在 ACR 上共享更多數據，而且它是禁運的，我們非常對我們在中度至重度人群中所看到的情況感到興奮。

So just stepping back, when you look at SLE, it is really a chronic disease, very heterogeneous, high global burden of disease, specifically in women and underserved population. And we believe that many options will be required.

因此，退一步來說，當你審視系統性紅斑狼瘡時，你會發現它確實是一種慢性疾病，非常異質，全球疾病負擔很高，特別是在女性和服務不足的人群中。我們相信需要很多選擇。

So I think while the bispecifics and the CAR-Ts may show efficacy in small population, we've got to keep in mind that these are very small data sets and likely may not be relevant to the entire population. And I think that here is where the scientific hypothesis and continuing to generate data sort of in Phase 2 that makes us believe that we could have a high probability of success in Phase 3 becomes really important. And with dapi, we're really addressing and inhibiting the CD40 ligand, which has the ability to reduce B and T cell activation, downregulating interferon pathways. And then with litifilimab, we're going after the Type 1 interferon signature and really looking at inhibiting BDCA2 in the plasma delta itself.

因此，我認為雖然雙特異性藥物和 CAR-T 可能在小群體中顯示出功效，但我們必須記住，這些數據集非常小，可能與整個群體無關。我認為，科學假設和在第二階段繼續產生數據使我們相信我們在第三階段有很高的成功機率變得非常重要。透過 dapi，我們真正解決並抑制 CD40 配體，它能夠減少 B 細胞和 T 細胞活化，下調幹擾素途徑。然後，利用litifilimab，我們正在尋找1型乾擾素特徵，並真正著眼於抑制血漿δ本身中的BDCA2。

So we believe that this is going to be really important and probably many options are required, but we remain really optimistic about the data that we've seen so far and the momentum that we have with our trials. So we continue to be believers in these pathways and these programs.

因此，我們相信這將非常重要，並且可能需要很多選擇，但我們對迄今為止看到的數據以及我們的試驗勢頭仍然非常樂觀。因此，我們繼續相信這些途徑和計劃。

With litifilumab, as you know, we're also addressing cutaneous lupus where really there has been no innovation in 70 years. So again, we have high scientific conviction, as Chris mentioned, and we'll continue to prosecute these.

如你所知，我們也利用 Litifilumab 來解決皮膚狼瘡問題，該領域 70 年來沒有任何創新。所以，正如克里斯所提到的，我們再次擁有高度的科學信念，我們將繼續起訴這些人。

And I'll just add, Umer, I was at GSK when we were developing BENLYSTA over 15 years ago, and we almost killed that program because of modest efficacy until we realize that everything else was failing, and this was the last product standing. And to date, only two products have been approved. Dapi would be the third. And I can tell you, over the years, we've seen an awful lot of data in small populations as Priya has said. And so I think we have to wait and see who actually gets to the finish line.

我想補充一點，Umer，15 年前我們在 GSK 開發 BENLYSTA 時，我們幾乎因為功效有限而終止了該項目，直到我們意識到其他所有產品都失敗了，而這是最後一個產品。到目前為止，只有兩種產品獲得批准。達皮將是第三個。我可以告訴你，多年來，正如 Priya 所說，我們已經在小群體中看到了大量數據。所以我認為我們必須等待，看看誰真正到達終點線。

On CAR-T, some interesting data, but the logistics of CAR-T are not yet such that you're going to be seeing significant numbers of patients being treated, in my personal opinion. So I think as Priya said, there's a need there today. We have a product that has demonstrated results, we're going full speed ahead. And just given the nature of this disease, I think you're going to find that there's not going to be any one product that ultimately is a winner. It's going to take different approaches.

在 CAR-T 方面，有一些有趣的數據，但在我個人看來，CAR-T 的後勤工作還不足以讓你看到大量患者正在接受治療。所以我認為正如 Priya 所說，今天有必要。我們的產品已經展示了成果，我們正在全速前進。考慮到這種疾病的性質，我想你會發現沒有任何一種產品最終會成為贏家。它將採取不同的方法。

Thank you, Chris. Next question please, operator.

謝謝你，克里斯。接線員，請下一個問題。

Jay Olson, Oppenheimer.

傑·奧爾森，奧本海默。

Hey, congrats on the quarter. And thank you for taking the question. We're curious about the $14 billion of peak revenue potential from your four key pipeline programs. Can you talk about the relative contribution and timing of the four products in terms of which ones are the largest and nearest term? Thank you.

嘿，恭喜這個季度。感謝您提出問題。我們對你們的四個關鍵管道項目的 140 億美元高峰收入潛力感到好奇。您能否談談這四種產品的相對貢獻和時間安排，其中哪些是最大和最接近的項目？謝謝。

Well, I don't want to get into giving individual revenue forecast. I think the idea was to give a sense of what's the magnitude of the pipeline. We all know that not everything can always succeed. But I do think if you look at where are there going to be significant programs. If you look at BIIB080 in Alzheimer's, we do believe, and I think Biogen is not the only one. I see Lilly and Roche continue to invest significantly. You've seen AbbVie lay out quite an awful lot of money for a very early-stage asset in Alzheimer's. So I think we all believe that as the health care system is ultimately able to adapt to the significant demand for treatment that this becomes an important market.

好吧，我不想給出個人收入預測。我認為這個想法是為了讓大家了解管道的規模。我們都知道，並不是所有事情都能成功。但我確實認為，如果你看看哪裡會有重要的項目。如果你看看 BIIB080 在阿茲海默症中的應用，我們確實相信這一點，而且我認為百健 (Biogen) 並不是唯一一家。我看到禮來公司和羅氏公司繼續進行大量投資。你已經看到艾伯維（AbbVie）為阿茲海默症的早期資產投入了大量資金。所以我認為我們都相信，隨著醫療保健系統最終能夠適應巨大的治療需求，這將成為一個重要的市場。

And what we can see, and I was just at a major world-class medical school last week, spent a day there with a lot of researchers in Alzheimer's. They are excited about tau in a way that we have not seen always at Abeta. Alzheimer's severity really varies with the level of tau and people really believe -- a lot of people in the field really believe that going after tau will really have a significant benefit for patients. So we do think that BIIB080 is certainly a product with a tremendous amount of potential. And as Priya said, we have dapi, but we also have litifilimab and also felza in lupus nephritis.

我們可以看到，上週我剛在一所世界一流的醫學院裡，與許多阿茲海默症研究人員在那裡度過了一天。他們對 tau 蛋白感到興奮，這是我們在 Abeta 從未見過的。阿茲海默症的嚴重程度確實會隨著 tau 蛋白的水平而變化，人們確實相信——該領域的許多人確實相信，追求 tau 蛋白確實會給患者帶來顯著的好處。因此，我們確實認為 BIIB080 無疑是一款具有巨大潛力的產品。正如 Priya 所說，我們有 dapi，但我們也有用於治療狼瘡性腎炎的 litifilimab 和 felza。

So we do see that lupus is going to be a significant market. And again, you look at you look at BENLYSTA that is selling at about $3 billion a year. And then there's an AstraZeneca product that hasn't done as well, but you look at the numbers of patients, this is still a market where there's considerable room for expansion. In felza, we have three Phase 3 programs going in, and we see all of those three indications as being a significant opportunity. So again, you add them up. $14 billion is kind of like the top number, but somewhere between $9 billion and $14 billion is what our teams have estimated.

所以我們確實看到狼瘡將成為一個重要的市場。再一次，你看看 BENLYSTA，它的年銷售額約為 30 億美元。還有一個阿斯特捷利康的產品做得不好，但你看看病人的數量，這仍然是一個有相當大的擴張空間的市場。在 felza，我們正在進行三個第三階段項目，我們認為這三個跡像都是一個重要的機會。再一次，你把它們加起來。 140 億美元有點像最高數字，但我們團隊的估計介於 90 億美元和 140 億美元之間。

Again, we have to wait and see what the clinical trial data looks like in the actual profile. But if you look at the potential of these markets and the unmet need and the potential for differentiation, we're becoming increasingly excited about this emerging pipeline.

同樣，我們必須等待，看看臨床試驗數據在實際情況中是什麼樣子。但如果你看看這些市場的潛力、未滿足的需求以及差異化的潛力，我們對這個新興的管道變得越來越興奮。

Thank you, Chris. Next question, please.

謝謝你，克里斯。請下一個問題。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO 資本市場。

Hi, guys. Thank you so much for taking my questions. I know in the past; we've talked about the potential for SPINRAZA returning to growth. Given the softer numbers this quarter, can you just talk about how you think that this is achieved. Is it predicated on high dose nusinersen? Or are there other factors and levers that you can pull to accelerate -- reaccelerate the growth of this product? Thank you.

嗨，大家好。非常感謝您回答我的問題。我知道過去；我們已經討論過 SPINAZA 恢復成長的潛力。鑑於本季的數據較為疲軟，您能否談談您認為如何實現這一目標？它是基於高劑量nusinersen嗎？或者是否有其他因素和槓桿可以加速—重新加速該產品的成長？謝謝。

Well, so globally, actually, if we take out some of the onetime effects of -- or sort of the exceptional effects of the ex-US, ex European markets, actually, we did see a growth for SPINRAZA. It's clearly a very competitive marketplace. And -- but it turns out that even though we have an intrathecal administration, that efficacy is really what matters in really severe diseases. And that's what we compete on. We had a study that has demonstrated, for example, the benefit of adding SPINRAZA on to Zolgensma as gene therapy. And we know that the oral therapies have limitations in terms of which patients can be treated.

好吧，實際上，在全球範圍內，如果我們剔除美國、歐洲市場以外的一些一次性影響或特殊影響，我們確實看到了 SPINRAZA 的成長。這顯然是一個競爭非常激烈的市場。而且──但事實證明，即使我們採用鞘內給藥，在真正嚴重的疾病中，療效才是真正重要的。這就是我們競爭的基礎。例如，我們的一項研究證明了在 Zolgensma 中添加 SPINRAZA 作為基因療法的益處。我們知道，口服療法在治療患者方面有其限制。

I think that our teams believe that DEVOTE is extremely important because we can get to the -- through the loading doses and get to the right level of therapeutic benefit faster than we could previously. And that actually reduces the number of intrathecal injections at least for the loading phase. So I think this is really an efficacy gain, but I'll ask Alisha, at least from a US perspective. How you see that?

我認為我們的團隊認為 DEVOTE 極為重要，因為我們可以透過負荷劑量，比以前更快達到正確的治療效果水準。這實際上減少了​​鞘內注射的次數，至少在負荷階段是如此。所以我認為這確實是一種功效增益，但我會問艾莉莎，至少從美國的角度來看。你怎麼看？

Thank you, Chris. And hello, Evan, thank you for the question. SPINRAZA has really been a very strong contributor, especially in the US business. So when you look at rare disease, we believe that SPINRAZA has really set that benchmark for what really excellent efficacy looks like and that it translates down to a patient. And so growth year-over-year, which my team has seen, and even that's during a time we've had two very strong competitors.

謝謝你，克里斯。你好，埃文，謝謝你的提問。斯賓拉扎確實是一個非常強大的貢獻者，尤其是在美國業務領域。因此，當您關注罕見疾病時，我們相信 SPINAZA 確實為真正出色的療效設定了基準，並將其轉化為患者。我的團隊已經看到了逐年成長，即使在我們有兩個非常強大的競爭對手的時期。

We had an oral launch during stay-at-home orders and the team is still really leading the way with SPINRAZA. And we do believe it's for a few reasons. One, the efficacy of the product is obviously very strong. And a lot of our growth also comes from switchback. There's a lot of patients that are returning back to SPINRAZA once they've switched away to a competitor, and they realize that maybe the efficacy isn't there. And so we do see quite a bit of that in the US.

我們在居家訂單期間進行了口頭發布，團隊仍然在 SPINRAZA 方面處於領先地位。我們確實相信這是有幾個原因的。一、產品功效明顯很強。我們的許多增長也來自之字形。有很多患者在轉用競爭對手後又回到了 SPINAZA，但他們意識到也許療效並不存在。所以我們在美國確實看到了很多這樣的情況。

And secondly, you fast forward eight years, we are still finding new patients in this space, and that's with three major biopharma companies putting money into this rare disease. And so you do see new patients still coming online. And we believe at least on the Biogen side, we are very good at patient finding. We're able to find them quite quickly. We have an excellent AI sort of machine that we use along with the field force.

其次，快轉八年，我們仍在這個領域尋找新患者，而三大生物製藥公司都在投資這種罕見疾病。所以你確實看到新的病人仍在上網。我們相信，至少在百健（Biogen）方面，我們非常擅長尋找患者。我們能夠很快找到他們。我們擁有一種出色的人工智慧機器，可以與現場人員一起使用。

We're able to locate them in centers of excellence and physicians are able to reach out and find these patients. And so with high dose coming, one of the pieces of feedback you do get from physicians and patients is, we just wish we had more. And so with that, we're preparing right now for that, obviously, the filing and the potential approval going into label, and we do believe that high dose will also support growth quarter-over-quarter, year-on-year for at least the US organization.

我們能夠將他們定位在卓越中心，醫生也能夠聯繫並找到這些患者。因此，隨著高劑量的到來，您從醫生和患者那裡得到的回饋之一是，我們只是希望我們有更多。因此，我們現在正在為此做準備，顯然，申請和潛在的批准進入標籤，我們確實相信高劑量也將支持季度環比、同比增長至少是美國組織。

Thank you, Alisha. Next question please, operator.

謝謝你，艾莉莎。接線員，請下一個問題。

Paul Matteis, Stifel.

保羅馬蒂斯，斯蒂菲爾。

Hey. Thanks very much for taking the question. In connecting some of the dots here, Chris, as it relates to the hires you've made and some of your portfolio decisions around certain legacy high-risk assets, it feels like more and more Biogen is bolstering its expertise in neurology and maybe shifting away from neurology. Is that the right way we should think about things going forward? In other words, when you look at business development, do you have any appetite any more to take on risk in neuroscience? Or do you feel like immunology, rare areas that you have a lot of experience with historically are going to be the sweet spot going forward? Thanks.

嘿。非常感謝您提出問題。克里斯，在連接這裡的一些點時，因為它涉及到你所聘用的人員以及圍繞某些遺留高風險資產的一些投資組合決策，感覺越來越多的百健（Biogen）正在增強其在神經病學方面的專業知識，並且可能會發生轉變遠離神經科。這是我們思考未來事情的正確方式嗎？換句話說，當你看業務發展時，你還有興趣在神經科學領域承擔風險嗎？或者你覺得免疫學這個你在歷史上擁有豐富經驗的罕見領域將成為未來的最佳點？謝謝。

I would say, first, we're already long in neurology and neuroscience. I mean we have very significant investments, obviously, with the BIIB080 program, continued significant investment in LEQEMBI. We're still spending hundreds of millions of dollars every year on the LEQEMBI R&D. And we have actually a number of programs coming behind that in early-stage development. We're working on brain shuttle technology, but looking at other modalities in Alzheimer's, we still have earlier-stage programs in MS and ALS, a significant program in Parkinson's in partnership with Denali.

我想說，首先，我們在神經病學和神經科學領域已經有很長的歷史了。我的意思是，我們有非常重大的投資，顯然，透過 BIIB080 計劃，我們繼續對 LEQEMBI 進行重大投資。我們每年仍在 LEQEMBI 研發上花費數億美元。實際上，我們有許多專案處於早期開發階段。我們正在研究腦穿梭技術，但在研究阿茲海默症的其他治療方式時，我們仍然有 MS 和 ALS 的早期項目，這是與 Denali 合作的帕金森氏症的一個重要項目。

So I think we see neuroscience as somewhere where we already have a significant commitment. But to me, I think it's not a good idea to just be in one therapeutic area. And in addition, I think we actually already have capabilities beyond neuroscience, the whole MS franchise is really an immunology franchise. You treat MS through the immune system. And I do believe we have an awful lot of immunology capability and that certainly gave us the confidence to do the HI-Bio acquisition.

所以我認為我們將神經科學視為我們已經做出重大承諾的領域。但對我來說，我認為只專注於一個治療領域並不是一個好主意。此外，我認為我們實際上已經擁有神經科學以外的能力，整個 MS 專營權實際上是免疫學專營權。您可以透過免疫系統治療多發性硬化症。我確實相信我們擁有強大的免疫學能力，這無疑給了我們收購 HI-Bio 的信心。

I&I, I go to a number of biotech conferences and venture conferences. I&I has now become the second most important area in R&D after oncology. And so you're going to have an awful lot of emerging opportunities for BD in this space. Biogen has a tremendous capability in small volumes and high-value products, highly differentiated scientific cell. And I think immunology fits that build. Rare disease is really more of a commercial description than a scientific one, but we do have a commercial model in rare diseases that has an awful lot of capability that not everybody does. And so expanding into that area with that commercial model almost being, I would say, indication agnostic is an area that we can go.

I&I，我參加了許多生物技術會議和創投會議。 I&I現已成為繼腫瘤學之後第二重要的研發領域。因此，BD 在這個領域將會有大量的新興機會。百健 (Biogen) 在小批量高價值產品、高度差異化的科學細胞方面擁有巨大的能力。我認為免疫學適合這種結構。罕見疾病實際上更多的是一種商業描述，而不是科學描述，但我們確實有一種罕見疾病的商業模型，它具有並非每個人都擁有的強大功能。因此，我想說，擴展到該商業模式幾乎與適應症無關的領域是我們可以進入的領域。

And I don't think we're stretching our capabilities. There are some capabilities that we have to build. And in some ways, Fit for Growth was as much shifting some of the focus away from a traditional heavy focus on MS and being able to adopt some of these other capabilities. But I wouldn't -- we don't really want to get into those areas where we'd have to go up against really large pharma companies in the commercial model. We're not really into incremental innovation in Biogen. So I feel pretty comfortable that we can expand our horizons in certain areas of immunology, probably more related to rare diseases and neurological conditions in immunology, not necessarily things like RA or atopic dermatitis. But we have a legitimacy to play there, and we have the capability, and we can really take advantage of a lot of the really smart people within Biogen.

我不認為我們正在擴展我們的能力。我們必須建立一些能力。在某些方面，Fit for Growth 也將一些焦點從傳統上對 MS 的高度關注轉移開，並能夠採用其中一些其他功能。但我不會——我們真的不想進入那些我們必須在商業模式上與真正的大型製藥公司對抗的領域。我們並不真正熱衷於百健（Biogen）的漸進式創新。因此，我對我們可以擴大免疫學某些領域的視野感到非常滿意，這些領域可能與免疫學中的罕見疾病和神經系統疾病更相關，而不一定是像 RA 或異位性皮膚炎這樣的疾病。但我們在那裡有合法性，我們有能力，我們可以真正利用百健（Biogen）內部許多真正聰明的人。

Thank you, Chris. Can we move to our last question please.

謝謝你，克里斯。我們可以轉到最後一個問題嗎？

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

Thanks for taking the question. Mike, I was just wondering if you can help us think directionally about margins for 2025 and some of the puts and takes. Thank you.

感謝您提出問題。麥克，我只是想知道您是否可以幫助我們定向思考 2025 年的利潤率以及一些看跌期權和賣出期權。謝謝。

Sure. And I'm going to assume, Terence, that you're referring primarily to our operating income margin. But I think we've made really good progress. The improvement in the third quarter, it was a little bit less than what you've seen. There's a little bit of lumpiness to it. And I think it's probably -- and some of that was driven by the revenue dynamics that we talked about in the quarter and some of the higher margin revenue like SPINRAZA and SKYCLARYS. But I think if you look at it on a year-to-date basis, that's probably the best way. We're 7% up year-to-date on the operating income line, a 7-percentage point improvement, I should say, it's 23% growth year-on-year.

當然。特倫斯，我假設您主要指的是我們的營業利潤率。但我認為我們已經取得了非常好的進展。第三季的改善，比你看到的少。它有一點塊狀。我認為這可能是——其中一些是由我們在本季度討論的收入動態以及 SPINRAZA 和 SKYCLARYS 等一些利潤率較高的收入推動的。但我認為，如果你從今年迄今的情況來看，這可能是最好的方法。今年迄今為止，我們的營業收入成長了 7%，提高了 7 個百分點，我應該說，比去年同期成長了 23%。

In our guidance, we talk about mid-single-digit improvement for the full year and high-teens growth for full year. And I think that we feel good about the improvement that we've made. We still feel confident that we can garner the $1 billion gross and $800 million net savings, which will continue to help our margins. And we're not guiding beyond this year, but as we exit 2024 and head into 2025, I think it's important to remember that we've said that the $800 million of savings we expected to get half of that by the end of this year and the other half next year. So that will continue to improve our margin profile as we go.

在我們的指導中，我們談論全年中個位數的改善和全年高雙位數的成長。我認為我們對所取得的進步感到滿意。我們仍然有信心獲得 10 億美元的毛利率和 8 億美元的淨利率，這將繼續提高我們的利潤率。我們不會在今年之後提供指導，但當我們退出 2024 年並進入 2025 年時，我認為重要的是要記住，我們已經說過，我們預計到今年年底將節省一半的 8 億美元明年的另一半。因此，這將繼續改善我們的利潤狀況。

Thank you, Mike, and thank you, everyone, for joining us today. Of course, the IR team will be available to answer any additional questions. Thank you.

謝謝麥克，也謝謝大家今天加入我們。當然，IR 團隊將可以回答任何其他問題。謝謝。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。