Biogen Inc (BIIB) 2022 Q1 法說會逐字稿

Good morning. My name is Cecilia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen First Quarter 2022 Earnings Call and Business Update. (Operator Instructions) Thank you. I would now like to turn the conference over to Mr. Mike Hencke, Head of Investor Relations. Mr. Hencke, you may begin your conference.

早上好。我叫 Cecilia，今天我將擔任您的會議接線員。在這個時候，我想歡迎大家參加百健（Biogen）公司 2022 年第一季度財報電話會議和業務更新。 （操作員說明）謝謝。我現在想將會議轉交給投資者關係主管 Mike Hencke 先生。 Hencke 先生，你可以開始你的會議了。

Thank you. Good morning, and welcome to Biogen's First Quarter 2022 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.

謝謝你。早上好，歡迎參加 Biogen 2022 年第一季度財報電話會議。在我們開始之前，我鼓勵大家去 biogen.com 的投資者部分查找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 財務指標的對賬。

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 have also posted slides on our website that follow the discussions related to this call.

表 1 和表 2 提供了我們的 GAAP 財務數據，表 4 包括了我們的 GAAP 與非 GAAP 財務結果的對賬。我們相信非公認會計準則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，以跟踪與此電話會議相關的討論。

I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. 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和信念做出前瞻性陳述。這些陳述受到某些風險和不確定性的影響，我們的實際結果可能存在重大差異。我鼓勵您查閱我們提交給 SEC 的文件中討論的風險因素以獲取更多詳細信息。

On today's call, I am joined by our Chief Executive Officer, Michel Vounatsos; Dr. Priya Singhal, Interim Head of Research and Development; and our CFO, Mike McDonnell. As a reminder, during the Q&A portion of the call, we kindly ask that you limit yourself to one question. I will now turn the call over to Michel.

在今天的電話會議上，我們的首席執行官 Michel Vounatsos 加入了我的行列； Priya Singhal 博士，研發臨時主管；和我們的首席財務官 Mike McDonnell。提醒一下，在電話的問答部分，我們懇請您將自己限制在一個問題上。我現在將把電話轉給米歇爾。

Thank you, Mike. Good morning, everyone, and thank you for joining us. We continue to execute on our core business objectives in the first quarter. Mike and Priya will review our quarterly performance and recent progress in R&D, while I focus on our strategy and near-term operational priorities.

謝謝你，邁克。大家早上好，感謝您加入我們。我們將在第一季度繼續執行我們的核心業務目標。 Mike 和 Priya 將回顧我們的季度業績和最近的研發進展，而我則專注於我們的戰略和近期運營重點。

Let me start with a few comments on the recent national coverage determination by CMS for amyloid beta targeted therapies for Alzheimer's disease. This decision effectively denies all Medicare beneficiaries access to ADUHELM. We are very disappointed by the final NCD. And as a result, we will substantially eliminate our commercial infrastructure for ADUHELM. We will retain minimal resources to manage patient access programs, including a continued free drug program for patients currently on treatment in the U.S.

讓我先談談 CMS 最近對阿爾茨海默病澱粉樣蛋白 β 靶向治療的全國覆蓋率確定。這一決定有效地拒絕了所有 Medicare 受益人使用 ADUHELM。我們對最終的非傳染性疾病感到非常失望。因此，我們將大幅消除 ADUHELM 的商業基礎設施。我們將保留最少的資源來管理患者訪問計劃，包括為目前在美國接受治療的患者提供持續的免費藥物計劃。

We expect to continue funding certain regulatory and R&D activities for ADUHELM, including the continuation of our EMBARK re-dosing study and the initiation of our Phase IV post-marketing requirement study, ENVISION. Additional actions regarding ADUHELM may be informed by upcoming data readouts expected for this class of antibodies as well as further engagement with the FDA and CMS.

我們希望繼續為 ADUHELM 的某些監管和研發活動提供資金，包括繼續我們的 EMBARK 重新給藥研究和啟動我們的 IV 期上市後需求研究 ENVISION。有關 ADUHELM 的其他行動可能會通過即將發布的此類抗體的預期數據讀數以及與 FDA 和 CMS 的進一步接觸來告知。

In parallel, we are committed to working closely with Eisai on the potential launch of lecanemab. We are now looking forward as we work to advance our broader pipeline, including lecanemab and zuranolone, execute on our base business and deploy our capital in the best interest of shareholders. We recognize that Biogen is facing a number of near-term challenges. These challenges, including generic erosion of TECFIDERA, competition for SPINRAZA in biosimilars (inaudible) and a declining profit share from RITUXAN in the U.S.

同時，我們致力於與衛材密切合作，共同推出 lecanemab。我們現在期待著我們努力推進我們更廣泛的管道，包括 lecanemab 和 zuranolone，執行我們的基礎業務並為股東的最佳利益部署我們的資本。我們認識到百健（Biogen）正面臨許多近期挑戰。這些挑戰包括 TECFIDERA 的仿製藥侵蝕、 SPINRAZA 在生物仿製藥中的競爭（聽不清）以及 RITUXAN 在美國的利潤份額下降。

These challenges are all part of the biopharmaceutical business lifecycle, and we believe that potential new product launches such as lecanemab, zuranolone and additional biosimilars can help return the company to grow over time. Further, we see the potential for additional growth driver in the mid- to late 2020s in other areas such as stroke, lupus and Parkinson's disease. And of course, we will be pursuing new business development opportunities as well. However, given that we are in a long product cycle business and in light of the CMS decision, we recognize there is more we must do today to provide better clarity and visibility into the company's future.

這些挑戰都是生物製藥業務生命週期的一部分，我們相信，lecanemab、zuranolone 和其他生物仿製藥等潛在新產品的推出可以幫助公司隨著時間的推移恢復增長。此外，我們認為 2020 年代中後期在中風、狼瘡和帕金森病等其他領域可能會出現額外的增長動力。當然，我們也將尋求新的業務發展機會。然而，鑑於我們的產品週期很長，並且鑑於 CMS 的決定，我們認識到我們今天必須做更多的事情來為公司的未來提供更好的清晰度和可見性。

Let me share the priority actions we are implementing now. First, we are increasing our focus on R&D prioritization with the goal of maximizing the probability of success, which Priya will further discuss. This prioritization process will be informed in part by key data readouts expected in 2022. In Alzheimer's disease, together with Eisai, we plan to complete the rolling submission for lecanemab under the accelerated approval pathway in the U.S. during the second quarter of this year. In addition, we expect a readout of the Phase III Clarity AD confirmatory trial for lecanemab this fall.

讓我分享一下我們現在正在實施的優先行動。首先，我們正在增加對研發優先級的關注，以最大限度地提高成功概率，Priya 將進一步討論這一點。預計 2022 年公佈的關鍵數據將在一定程度上為這一優先排序過程提供信息。在阿爾茨海默病方面，我們計劃與衛材一起，在今年第二季度在美國的加速批准途徑下完成 lecanemab 的滾動提交。此外，我們預計今年秋天將公佈 lecanemab 的 III 期 Clarity AD 確認試驗。

Based on the results of the study, we plan to submit for full FDA approval by the first quarter of 2023 with the opportunity for lecanemab to become the first anti-amyloid antibody to obtain full approval for Alzheimer's disease in the U.S. In neuropsychiatry, we are working with Sage to advance zuranolone as an important new potential option for MDD and PPD. We recently initiated the rolling submission of zuranolone in MDD and expect to complete the filing in the second half of 2022.

根據研究結果，我們計劃在 2023 年第一季度之前提交 FDA 的全面批准，這將有機會讓 lecanemab 成為美國第一個獲得阿爾茨海默病全面批准的抗澱粉樣蛋白抗體。在神經精神病學方面，我們正在與 Sage 合作，推進 zuranolone 作為 MDD 和 PPD 的重要新潛在選擇。我們最近在 MDD 啟動了 zuranolone 的滾動提交，預計將在 2022 年下半年完成備案。

We also look forward to the Phase III SKYLARK study readout in PPD, expected mid this year with an associated filing for PPD anticipated early next year. Also in neuropsychiatry, we expect the Phase II readout for BIIB104 in cognitive impairment associated with schizophrenia in mid-2022. Second, we will implement additional cost reduction and productivity measures above and beyond our previously communicated initiatives to further align our costs with our revenue base. These measures will include the substantial elimination of our commercial infrastructure supporting ADUHELM as well as other cost reduction while we continue to fund promising pipeline and commercial opportunities.

我們還期待在 PPD 中進行 III 期 SKYLARK 研究讀數，預計將於今年年中發布，預計明年初將提交 PPD 相關文件。同樣在神經精神病學方面，我們預計 BIIB104 在 2022 年中期與精神分裂症相關的認知障礙中的 II 期讀數。其次，我們將在之前傳達的舉措之外實施額外的成本降低和生產力措施，以進一步使我們的成本與我們的收入基礎保持一致。這些措施將包括大幅取消支持 ADUHELM 的商業基礎設施以及降低其他成本，同時我們將繼續為有前景的管道和商業機會提供資金。

Third, we are executing on international growth opportunities with a focus on key emerging markets, such as China and certain markets in both Latin America and the Middle East. This includes the continued launch of SPINRAZA and may also include pursuing local business development opportunities. Fourth, we plan to drive renewed growth in our biosimilars business, although our portfolio of anti-TNF products is likely past the peak of its lifecycle. We currently have 4 more programs in development, and in the near term, we are preparing to launch BYOOVIZ, referencing Lucentis in the U.S. in the coming months.

第三，我們正在抓住國際增長機會，重點關注主要新興市場，例如中國以及拉丁美洲和中東的某些市場。這包括繼續推出 SPINRAZA，還可能包括尋求當地業務發展機會。第四，我們計劃推動生物仿製藥業務的新增長，儘管我們的抗 TNF 產品組合可能已經過了生命週期的高峰期。我們目前還有 4 個項目正在開發中，在短期內，我們正準備推出 BYOOVIZ，並在未來幾個月內參考美國的 Lucentis。

Our fifth near-term priority is capital allocation. Biogen is fortunate to have a strong balance sheet with $4.8 billion in cash as of the end of the quarter and modest net debt, as well as strong cash flow generation. Going forward, we plan to continue to focus the deployment of cash towards initiatives designed to create incremental revenue growth opportunities, while continuing to return cash to shareholders through share repurchases.

我們的第五個近期優先事項是資本配置。 Biogen 很幸運擁有強勁的資產負債表，截至本季度末擁有 48 億美元的現金和適度的淨債務，以及強勁的現金流產生。展望未來，我們計劃繼續將現金部署集中在旨在創造增量收入增長機會的計劃上，同時繼續通過股票回購向股東返還現金。

In summary, the challenges faced by the company over the last -- the past 12 months have been significant. We are committed to taking advantage of all the strengths we have, including our talent, our commercial portfolio, our manufacturing capabilities, our pipeline, which includes 10 programs in Phase III or filed and of course, our strong balance sheet to deliver on the performance that is expected from us.

總而言之，公司在過去（過去 12 個月）所面臨的挑戰是巨大的。我們致力於利用我們擁有的所有優勢，包括我們的人才、我們的商業組合、我們的製造能力、我們的管道，其中包括 10 個處於第三階段或已提交的項目，當然還有我們強大的資產負債表來實現業績這是我們所期望的。

Let me conclude by saying that it has been an honor to lead this outstanding company during such a challenging period of time and to work closely with so many dedicated and talented colleagues. I am very proud of all that we have achieved. I want to thank the Board of Directors and my colleagues for their support during this period. I will be leaving at a time of promise for Biogen with noteworthy potential for value creation, and I look forward working with my successor through a smooth transition.

最後讓我說，在如此充滿挑戰的時期領導這家傑出的公司，並與這麼多敬業和才華橫溢的同事密切合作，我感到非常榮幸。我為我們所取得的一切感到非常自豪。我要感謝董事會和我的同事在此期間的支持。我將在百健（Biogen）承諾創造價值的時候離開，我期待與我的繼任者一起順利過渡。

I will now turn the call over to Priya for an update on our recent progress in R&D.

我現在將把電話轉給 Priya，以了解我們最近在研發方面取得的進展。

Thank you, Michel, and good morning, everyone. As Michel mentioned, we are enhancing our focus on dynamic R&D prioritization with the goal of ensuring a sustainable pipeline that can deliver on Biogen's vision of a multi-franchise portfolio. We will continue to invest in R&D in a disciplined manner, including pursuing new and external opportunities with a potentially different risk/reward profile encompassing those within our core neuroscience therapeutic areas as well as select investments in therapeutic adjacencies.

謝謝你，米歇爾，大家早上好。正如 Michel 所提到的，我們正在加強對動態研發優先級的關注，以確保可持續的管道能夠實現 Biogen 的多特許經營組合願景。我們將繼續以有紀律的方式投資於研發，包括尋求具有潛在不同風險/回報特徵的新的和外部機會，包括我們核心神經科學治療領域內的那些，以及對鄰近治療的選擇投資。

This approach will be informed by emerging scientific data, as well as internal and external readouts. As part of our overall prioritization strategy, we may choose to accelerate, terminate, divest or partner certain programs. In addition, we will continue to advance key capabilities such as functional genomics, patient identification, novel modalities, biomarkers and clinical outcome measures. The goal being to reduce risk, accelerate clinical development and increase the probability of success in achieving positive proof of concept.

新出現的科學數據以及內部和外部讀數將為這種方法提供信息。作為我們整體優先戰略的一部分，我們可能會選擇加速、終止、剝離或合作某些項目。此外，我們將繼續推進功能基因組學、患者識別、新模式、生物標誌物和臨床結果測量等關鍵能力。目標是降低風險、加速臨床開發並增加成功實現概念驗證的可能性。

I will now share the R&D highlights of the quarter. Starting with Alzheimer's disease. In addition to continuing the progress with lecanemab U.S. filing and the Phase III study, Eisai presented data at the annual AD/PD meeting this past March showing that lecanemab treatment in the core Phase IIb study resulted in a dose and time-dependent reduction of brain amyloid as measured by PET SUVR and that the reduction of brain amyloid was co-related with changes in 2 important peripheral biomarkers of amyloid and tau pathology, specifically an increase in plasma Abeta 42/40 ratio and a decrease in plasma phospho-tau 181, respectively.

我現在將分享本季度的研發亮點。從阿爾茨海默病開始。除了繼續推進 lecanemab 美國申請和 III 期研究外，衛材還在今年 3 月的 AD/PD 年度會議上提供了數據，顯示核心 IIb 期研究中的 lecanemab 治療導致腦劑量和時間依賴性減少通過 PET SUVR 測量的澱粉樣蛋白，腦澱粉樣蛋白的減少與澱粉樣蛋白和 tau 病理學的 2 個重要外周生物標誌物的變化相關，特別是血漿 Abeta 42/40 比率的增加和血漿磷酸化 tau 181 的減少，分別。

Furthermore, these biomarker changes were correlated with clinical benefit as assessed by the change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes. Notably, however, these peripheral biomarkers gradually began to reverse upon discontinuation of lecanemab treatment at the end of the core study, suggesting that stopping dosing prematurely may allow re-accumulation of Alzheimer's disease pathology.

此外，這些生物標誌物變化與臨床益處相關，如臨床癡呆評定量表-框總和中從基線的變化所評估的那樣。然而，值得注意的是，這些外周生物標誌物在核心研究結束時停止 Lecanemab 治療後逐漸開始逆轉，這表明過早停止給藥可能會導致阿爾茨海默病病理的重新積累。

Eisai also presented additional information on ARIA from the lecanemab Phase IIb study. This included the incidence of ARIA-E in the open-label extension where ARIA-E was observed in less than 10% of participants receiving 10-milligram per kg lecanemab biweekly and a symptomatic ARIA rate of less than 2%, consistent with the core study. We look forward to further defining the safety and efficacy of lecanemab through the larger Phase III Clarity AD study.

衛材還提供了 lecanemab IIb 期研究中關於 ARIA 的更多信息。這包括開放標籤擴展中 ARIA-E 的發生率，其中 ARIA-E 在不到 10% 的參與者中觀察到，每兩週接受 10 毫克/公斤萊卡尼單抗，症狀性 ARIA 率低於 2%，與核心一致學習。我們期待通過更大規模的 III 期 Clarity AD 研究進一步確定 lecanemab 的安全性和有效性。

Biogen and Eisai are currently evaluating subcutaneous dosing in a substudy of the Clarity AD open-label extension, which will evaluate subcutaneous injections compared to IV infusions. This is in addition to the ongoing AHEAD 3-45 study evaluating lecanemab in people with preclinical Alzheimer's disease or prior to cognitive impairment, which was initiated back in 2020.

百健（Biogen）和衛材（Eisai）目前正在評估 Clarity AD 開放標籤擴展的子研究中的皮下給藥，該研究將評估皮下注射與 IV 輸注的比較。這是對正在進行的 AHEAD 3-45 研究的補充，該研究評估了臨床前阿爾茨海默病患者或認知障礙之前的 lecanemab，該研究於 2020 年啟動。

Beyond lecanemab, Biogen continues to pursue new treatments across molecular targets in Alzheimer's disease. This includes actively planning for the Phase II study of BIIB080, our tau ASO, and initiation of dosing in the Phase I study of BIIB113. BIIB113 is a small molecule inhibitor of O-GlcNAcase or OGA, an enzyme believed to catalyze the removal of (inaudible) post-translational modification of the tau protein. By inhibiting OGA, we aim to increase the (inaudible) of tau to potentially inhibit tau aggregation and thereby slow clinical decline.

除了 lecanemab，Biogen 繼續在阿爾茨海默病的分子靶點上尋求新的治療方法。這包括積極規劃 BIIB080、我們的 tau ASO 的 II 期研究，以及在 BIIB113 的 I 期研究中開始給藥。 BIIB113 是一種 O-GlcNAcase 或 OGA 的小分子抑製劑，OGA 是一種被認為可催化去除 tau 蛋白（聽不清）翻譯後修飾的酶。通過抑制 OGA，我們的目標是增加 tau 的（聽不清）以潛在地抑制 tau 聚集，從而減緩臨床衰退。

As Michel mentioned, with aducanumab, we are also continuing to collect data in our EMBARK re-dosing study and working towards the initiation of ADUHELM Phase IV post-marketing requirement study, ENVISION.

正如 Michel 所提到的，對於 aducanumab，我們還在繼續收集 EMBARK 再給藥研究中的數據，並致力於啟動 ADUHELM IV 期上市後需求研究 ENVISION。

Moving to neuropsychiatry. Biogen and Sage recently announced that we initiated the rolling submission of a new drug application to the FDA for zuranolone in MDD. We expect to complete the filing in the second half of this year. We were also excited to announce that the zuranolone Phase III CORAL study in major depressive disorder met the primary endpoint and key secondary endpoint. The CORAL study was a randomized blinded trial designed to assess rapidity of response when zuranolone 50 milligrams is co-initiated with an open-label standard of care antidepressant or ADT versus placebo co-initiated with ADT, as measured by the change from baseline on the 17-item Hamilton Depression Rating Scale.

轉向神經精神病學。 Biogen 和 Sage 最近宣布，我們開始向 FDA 滾動提交一份用於治療 MDD 的 zuranolone 的新藥申請。我們預計在今年下半年完成備案。我們還很高興地宣布，zuranolone III 期 CORAL 研究在重度抑鬱症中達到了主要終點和關鍵次要終點。 CORAL 研究是一項隨機盲法試驗，旨在評估當 zuranolone 50 毫克與開放標籤標準護理抗抑鬱藥或 ADT 共同啟動時與安慰劑與 ADT 共同啟動時的反應速度，通過從基線的變化來衡量17 項漢密爾頓抑鬱量表。

Top line results showed that zuranolone co-initiated with ADT resulted in a statistically significant reduction in depressive symptoms at day 3, the primary endpoint and the earliest time point measured, as well as over the full 2-week treatment period as compared to placebo co-initiated with ADT. Zuranolone was generally well tolerated with most treatment-emergent adverse events reported as mild or moderate. In MDD, zuranolone has now delivered 4 positive randomized controlled trials in total, as well as important insights on repeat treatment from the SHORELINE study, a large prospective naturalistic study in MDD. While these trials were designed to address different questions, we see a consistent profile of zuranolone that includes rapid reduction in depressive symptoms compared to the standard of care antidepressants, a consistent tolerability profile with a low discontinuation rate due to adverse events and without observed weight gain, sexual dysfunction or suicidal ideation; a short course of treatment that can be potentially taken as needed; and a flexible treatment approach that may provide optionality to HCPs and patients.

頂線結果顯示，與安慰劑聯合治療相比，與 ADT 共同啟動的 zuranolone 在第 3 天、主要終點和測量的最早時間點以及整個 2 周治療期間導致抑鬱症狀顯著減少。 - 以 ADT 啟動。 Zuranolone 通常耐受性良好，大多數治療出現的不良事件報告為輕度或中度。在 MDD 中，zuranolone 現在總共提供了 4 項陽性隨機對照試驗，以及來自 SHORELINE 研究的重複治療的重要見解，這是 MDD 中的一項大型前瞻性自然研究。雖然這些試驗旨在解決不同的問題，但我們看到 zuranolone 的一致特徵包括與標準護理抗抑鬱藥相比抑鬱症狀迅速減輕、一致的耐受性特徵、因不良事件而停藥率低且未觀察到體重增加、性功能障礙或自殺意念；可以根據需要進行的短期治療；以及一種靈活的治療方法，可為 HCP 和患者提供選擇權。

This is in addition to positive data from the Phase III ROBIN study of zuranolone in postpartum depression. We look forward to the Phase III SKYLARK study readout in PPD expected by midyear with an associated filing for PPD anticipated early next year. We look forward to potentially bringing a rapid onset, well-tolerated oral antidepressant with sustained effects and a new mechanism of action to patients suffering from depression.

這是對產後抑鬱症中 zuranolone III 期 ROBIN 研究的積極數據的補充。我們期待著 PPD 中的 III 期 SKYLARK 研究讀數預計在年中發布，並預計在明年初提交 PPD 的相關文件。我們期待有可能為抑鬱症患者帶來一種起效快、耐受性良好的口服抗抑鬱藥，具有持續的效果和新的作用機制。

Moving to ALS. We previously reported that while the Phase III VALOR study for tofersen in SOD1-ALS, a rare genetic form of ALS, did not achieve the primary endpoint of a statistically significant change on the ALSFRS-R at week 28 versus placebo. We did observe signs of reduced disease progression across multiple secondary and exploratory endpoints. We plan to present integrated data from the Phase III VALOR study and a new interim analysis of its ongoing open-label extension at the upcoming ENCALS meeting in June.

轉移到 ALS。我們之前曾報導過，雖然在 SOD1-ALS（一種罕見的 ALS 遺傳形式）中對 tofersen 進行的 III 期 VALOR 研究並未達到第 28 週時 ALSFRS-R 與安慰劑相比發生統計學顯著變化的主要終點。我們確實在多個次要和探索性終點觀察到疾病進展減少的跡象。我們計劃在即將於 6 月召開的 ENCALS 會議上展示 III 期 VALOR 研究的綜合數據以及對其正在進行的開放標籤擴展的新中期分析。

This interim analysis includes data from participants with SOD1-ALS, who had the opportunity for at least 1 year of follow-up from the start of VALOR. Long-term data on measures of function, strength, quality of life and survival will be presented. We also continue to recruit for ATLAS, a study evaluating tofersen in presymptomatic participants with a confirmed SOD1 mutation, while also supporting the global tofersen expanded access program, which includes approximately 120 people with SOD1-ALS to date from more than a dozen countries.

該中期分析包括來自 SOD1-ALS 參與者的數據，他們有機會從 VALOR 開始進行至少 1 年的隨訪。將提供有關功能、力量、生活質量和生存的長期數據。我們還繼續為 ATLAS 招募人員，這是一項評估確認 SOD1 突變的症狀前參與者的 tofersen 的研究，同時還支持全球 tofersen 擴大訪問計劃，其中包括迄今為止來自十幾個國家的約 120 名 SOD1-ALS 患者。

We also remain engaged with regulators on potential next steps for tofersen. As you can see, 2022 is an important year for Biogen R&D with several important milestones expected as we continue to advance a diversified pipeline that contains a total of 32 clinical programs with 10 programs in either Phase III or being filed. These milestones include key regulatory filings, mid- to late-stage readouts in both Alzheimer's disease and neuropsychiatry, initiation of late-stage studies in Parkinson's disease, and starting a pivotal study in cutaneous lupus erythematosus, in addition to ongoing recruitment for 2 Phase III lupus programs in SLE, as well as planning next steps for the BIIB131 stroke program.

我們還繼續與監管機構就 tofersen 的潛在下一步行動進行接觸。如您所見，2022 年對於百健（Biogen）研發來說是重要的一年，隨著我們繼續推進多元化的管道，該管道包含總共 32 個臨床項目，其中 10 個項目處於 III 期或正在申請中，預計會有幾個重要的里程碑。這些里程碑包括關鍵的監管文件、阿爾茨海默病和神經精神病學的中晚期讀數、帕金森病晚期研究的啟動、皮膚紅斑狼瘡的關鍵研究以及正在進行的 2 III 期招募SLE 中的狼瘡項目，以及 BIIB131 中風項目的下一步計劃。

In summary, we are taking actions that we believe will enable delivery of a number of potential first-in-class and best-in-class molecules to patients suffering from diseases with significant unmet need. I will now pass the call over to Mike.

總之，我們正在採取行動，我們相信這些行動將使許多潛在的一流和一流的分子能夠交付給患有嚴重需求未得到滿足的疾病的患者。我現在將把電話轉給邁克。

Thank you, Priya, and good morning, everyone. I will provide some key highlights around the financial performance for the quarter and review our full year 2022 guidance. Please note that all financial comparisons are versus the prior year, unless otherwise noted.

謝謝你，普里亞，大家早上好。我將圍繞本季度的財務業績提供一些關鍵亮點，並回顧我們的 2022 年全年指導。請注意，除非另有說明，否則所有財務比較均與上一年進行比較。

Total revenue for the first quarter was $2.5 billion. Our MS business inclusive of OCREVUS Royalties delivered $1.6 billion in revenue. TECFIDERA continues to be impacted by generic entry in the U.S. and was negatively impacted by pricing pressure outside of the U.S. VUMERITY first quarter global revenue was $128 million. We are pleased with VUMERITY's trajectory in the U.S. and are making good progress towards launching in up to 20 markets outside the U.S. this year.

第一季度總收入為 25 億美元。我們的 MS 業務（包括 OCREVUS 版稅）實現了 16 億美元的收入。 TECFIDERA 繼續受到美國仿製藥進入的影響，並受到美國以外的定價壓力的負面影響。 VUMERITY 第一季度全球收入為 1.28 億美元。我們對 VUMERITY 在美國的發展軌跡感到滿意，並在今年在美國以外的多達 20 個市場推出方面取得了良好進展。

TYSABRI global revenue increased 3%. In the U.S., TYSABRI revenue benefited from favorable pricing that more than offset modest volume declines. Outside the U.S., we were pleased to see continued patient growth. Interferon global revenue declined by 23% due to the continued shift from the injectable platforms to oral or high efficacy therapies.

TYSABRI 全球收入增長 3%。在美國，TYSABRI 的收入受益於有利的定價，抵消了適度的銷量下降。在美國以外，我們很高興看到患者持續增長。由於從注射平台持續轉向口服或高效療法，干擾素全球收入下降了 23%。

Moving now to SMA. SPINRAZA global revenue declined 9%. In the U.S., although revenue growth of 10% was driven by positive channel dynamics, we were encouraged to see new patient starts at the highest levels in over 2 years and a continued slowdown of discontinuations versus the prior quarter. Outside the U.S., the revenue decline was driven primarily by the timing of shipments in certain markets, competition and negative currency impacts, partially offset by strong initial uptake in China as this was the first full quarter since receiving national reimbursement in China. Global SPINRAZA revenue grew 7% versus Q4 of 2021, driven by solid sequential performance outside the U.S. as well as some seasonality dynamics in the U.S.

現在轉到 SMA。 SPINRAZA 全球收入下降 9%。在美國，儘管 10% 的收入增長是由積極的渠道動態推動的，但我們很高興看到新患者的開工率達到 2 年來的最高水平，並且與上一季度相比，停藥率持續放緩。在美國以外，收入下降的主要原因是某些市場的發貨時間、競爭和負面貨幣影響，部分被中國的強勁初始吸收所抵消，因為這是自中國獲得國家報銷以來的第一個完整季度。全球 SPINRAZA 收入與 2021 年第四季度相比增長了 7%，這得益於美國以外地區的穩健連續表現以及美國的一些季節性動態。

Moving to our biosimilars business, revenue declined 5%, while volume increased, this was more than offset by pricing pressure and negative currency impacts. In April, we completed the transaction to sell our equity stake in our biosimilar joint venture. As a reminder, the economics for anti-TNF and ophthalmology programs will be substantially unchanged. In addition, we are preparing to launch BYOOVIZ in the U.S. in the coming months.

轉向我們的生物仿製藥業務，收入下降 5%，而銷量增加，這被定價壓力和負面貨幣影響所抵消。 4 月，我們完成了出售我們在生物仿製藥合資企業中的股權的交易。提醒一下，抗 TNF 和眼科項目的經濟性將基本保持不變。此外，我們正準備在未來幾個月內在美國推出 BYOOVIZ。

We expect a gradual launch with more meaningful revenue contribution starting in 2023. Overall, we expect full year biosimilars revenue to decrease versus the prior year due to pricing pressure in Europe. Total anti-CD20 revenue grew 3% with increased OCREVUS Royalties being partially offset by a continued decline in RITUXAN revenues due to biosimilar competition.

我們預計從 2023 年開始逐步推出並帶來更有意義的收入貢獻。總體而言，由於歐洲的定價壓力，我們預計全年生物仿製藥收入將比上年減少。抗 CD20 總收入增長 3%，其中 OCREVUS 特許權使用費的增加被生物仿製藥競爭導致 RITUXAN 收入持續下降部分抵消。

First quarter gross margin was negatively impacted by a $275 million charge for ADUHELM inventory write-offs as well as approximately $45 million of idle capacity charges. Note that Eisai's share of these charges is reflected in the collaboration profit sharing line.

第一季度毛利率受到 2.75 億美元的 ADUHELM 庫存沖銷費用以及約 4500 萬美元的閒置產能費用的負面影響。請注意，衛材在這些費用中的份額反映在合作利潤分享線中。

Moving now to expenses and the balance sheet. Q1 non-GAAP R&D expense was $552 million. Non-GAAP SG&A was $635 million, including approximately $80 million related to ADUHELM. Eisai's share of these costs are also reflected in the collaboration profit sharing line. First quarter collaboration profit sharing reduced our net operating expense by $117 million, which includes reimbursement of approximately $182 million from Eisai, partially offset by $64 million of net profit-sharing expense related to our collaboration with Samsung Bioepis.

現在轉到費用和資產負債表。第一季度非 GAAP 研發費用為 5.52 億美元。 Non-GAAP SG&A 為 6.35 億美元，包括與 ADUHELM 相關的約 8000 萬美元。衛材在這些成本中的份額也體現在合作利潤分成線上。第一季度的合作利潤分享使我們的淨運營費用減少了 1.17 億美元，其中包括來自衛材的約 1.82 億美元的報銷，部分被與三星 Bioepis 合作相關的 6400 萬美元的淨利潤分享費用所抵消。

In the first quarter, we generated approximately $162 million in cash flow from operations, which was negatively impacted by the timing of certain payments. Capital expenditures were $58 million and free cash flow was approximately $104 million. We ended the quarter with $7.3 billion in debt, $4.8 billion in cash and marketable securities and $2.5 billion in net debt. We subsequently also received approximately $1 billion from the sale of our JV equity to Samsung Biologics. Additionally, our $1 billion revolving credit facility was undrawn as of the end of the quarter.

在第一季度，我們從運營中產生了大約 1.62 億美元的現金流，這受到某些付款時間的負面影響。資本支出為 5800 萬美元，自由現金流約為 1.04 億美元。本季度末，我們的債務為 73 億美元，現金和有價證券為 48 億美元，淨債務為 25 億美元。隨後，我們還從向三星生物製品公司出售合資企業股權中獲得了約 10 億美元。此外，截至本季度末，我們的 10 億美元循環信貸額度尚未提取。

Overall, we remain in a very strong financial position with significant cash and financial capacity to invest in growing the business over the long term. Let me now turn to our updated full year guidance for 2022. We are reaffirming our full year revenue guidance of $9.7 billion to $10 billion. This revenue guidance reflects the strengthening of the U.S. dollar from January 1 through April 29, resulting in an estimated currency headwind of approximately $120 million, net of hedging activities. We are also reaffirming our full year non-GAAP diluted EPS guidance of $14.25 to $16 despite the $0.76 impact of ADUHELM inventory write-offs as well as an impact of approximately $0.35 related to the strengthening of the dollar that I just mentioned. Although our prior guidance did not assume either the inventory write-offs or the currency headwinds, we believe the additional cost measures announced today as well as better performance in our base business can largely offset these impacts. This financial guidance assumes continued declines in RITUXAN revenue due to biosimilar competition as well as continued erosion of TECFIDERA revenue in the U.S. due to generic entry. This guidance also continues to assume the potential entry of TECFIDERA generics in the EU in the second quarter of 2022.

總體而言，我們仍然處於非常強勁的財務狀況，擁有大量現金和財務能力，可以長期投資於發展業務。現在讓我談談我們更新的 2022 年全年收入指引。我們重申我們的 97 億美元至 100 億美元的全年收入指引。該收入指引反映了 1 月 1 日至 4 月 29 日美元的走強，導致扣除對沖活動後的匯率逆風估計約為 1.2 億美元。儘管 ADUHELM 庫存沖銷產生了 0.76 美元的影響，以及我剛才提到的與美元走強相關的約 0.35 美元的影響，我們也重申了我們全年非公認會計原則攤薄後每股收益 14.25 美元至 16 美元的指導。儘管我們之前的指導並未假設庫存沖銷或貨幣逆風，但我們相信今天宣布的額外成本措施以及我們基礎業務的更好表現可以在很大程度上抵消這些影響。本財務指導假設 RITUXAN 收入由於生物仿製藥競爭而持續下降，以及由於仿製藥進入美國 TECFIDERA 收入持續下降。該指南還繼續假設 TECFIDERA 仿製藥可能在 2022 年第二季度進入歐盟。

We expect to decrease revenue from these high-margin products as well as the ADUHELM inventory charges to reduce our gross margin percentage when compared with 2021. This guidance reflects the initial implementation of the additional cost reduction and productivity measures, which Michel discussed. These additional measures are expected to yield approximately $500 million in annualized savings in addition to the previously communicated initiatives already targeting approximately $500 million in annualized savings.

與 2021 年相比，我們預計將減少這些高利潤產品的收入以及 ADUHELM 庫存費用，以降低我們的毛利率百分比。該指導反映了 Michel 討論的額外成本降低和生產力措施的初步實施。這些額外措施預計將產生約 5 億美元的年化節省，此外，此前已傳達的計劃已經針對約 5 億美元的年化節省。

This brings total expected annualized savings to approximately $1 billion, a portion of which will be reinvested in strategic initiatives over the coming years. We expect non-GAAP R&D expense to be between $2.2 billion and $2.3 billion, which is unchanged from our previous guidance. Non-GAAP SG&A expense is expected to be between $2.3 billion and $2.4 billion, which is a decrease from prior guidance of $2.5 billion to $2.6 billion, which is due to the additional cost reduction measures just mentioned, which we expect to primarily impact the third and fourth quarters.

這使預計的年度總節省額達到約 10 億美元，其中一部分將在未來幾年重新投資於戰略計劃。我們預計非 GAAP 研發費用將在 22 億美元至 23 億美元之間，與我們之前的指導保持不變。非 GAAP SG&A 費用預計在 23 億美元至 24 億美元之間，低於之前的 25 億美元至 26 億美元的指導，這是由於剛剛提到的額外成本降低措施，我們預計這將主要影響第三個和第四季度。

This guidance assumes that foreign exchange rates as of April 29 will remain in effect for the remainder of the year, net of hedging activities and does not contemplate any further strengthening or weakening of the dollar throughout the year. We assume that we will utilize a portion of the remaining share repurchase authorization of $2.8 billion throughout the year. Please see our press release for other important guidance assumptions.

該指引假設截至 4 月 29 日的匯率將在今年剩餘時間內保持有效，扣除對沖活動，並且不考慮全年美元進一步走強或走弱。我們假設我們將在全年使用剩餘的 28 億美元股票回購授權的一部分。請參閱我們的新聞稿了解其他重要的指導假設。

So in summary, we continue to execute on our core business objectives this quarter and are now focused on a set of near-term operational priorities, which we believe can drive value creation over time. We'll now open the call for questions.

因此，總而言之，我們在本季度繼續執行我們的核心業務目標，現在專注於一系列近期運營重點，我們認為這些重點可以隨著時間的推移推動價值創造。我們現在將打開問題電話。

(Operator Instructions) Your first question comes from the line of Matthew Harrison from Morgan Stanley.

（操作員說明）您的第一個問題來自摩根士丹利的 Matthew Harrison。

Michel, I was hoping you could comment on the CEO transition here in terms of timing as well as what the Board is looking for in terms of the successor and wishing you all the best in the transition.

米歇爾，我希望您能在這裡就 CEO 交接的時間以及董事會在繼任者方面尋找的內容髮表評論，並祝您在交接過程中一切順利。

Thank you, Matthew. 5.5 years is a good term and if you look at my professional history, this was approximately the tenure in every key posting that I've had. I've given a lot, and I will continue to do so as a priority during the transition to support the team so that we can continue to deliver. Today, we reaffirmed our guidance. The business momentum is going as well as it could despite the competition and the lifecycle events that we are facing. We are exciting about -- excited about the readouts to come. And the adu and the anti-amyloid story is still unfolding. So the story will continue. And I'm very excited about the opportunity to have new readouts in that space that will best inform everything we've heard, including decisions.

謝謝你，馬修。 5.5 年是一個很好的術語，如果你看看我的職業經歷，這大約是我所有重要職位的任期。我付出了很多，在過渡期間我將繼續優先這樣做，以支持團隊，以便我們能夠繼續交付。今天，我們重申了我們的指導。儘管我們面臨著競爭和生命週期事件，但業務發展勢頭仍在繼續。我們對即將到來的讀數感到興奮。而阿杜和抗澱粉樣蛋白的故事仍在展開。所以故事還會繼續。我很高興有機會在該領域擁有新的讀數，這將最好地告知我們所聽到的一切，包括決策。

So the CEO transition is a natural event. And is there always an ideal timing? I'm not sure. But I think that after 5.5 years, while we have a strategy that is pretty visible to all of you being a specialized company in neuroscience with some immuno assets that are very important and in Phase III with the biosimilars and the digital health, I think the company is well positioned. It's good to have at one stage, somebody else who comes with the support of the Board and basically [revisit] the assumptions. So I think that this will be good for everyone involved. And my focus again will be on the company. It's not about me. It's about the company, on the team and on a smooth transition. Business continues. I will be meeting all of you in the coming days in person in Boston in New York.

因此，CEO 的過渡是自然而然的事情。總是有一個理想的時機嗎？我不確定。但我認為，在 5.5 年後，雖然我們的戰略對你們所有人來說都是顯而易見的，它是一家神經科學專業公司，擁有一些非常重要的免疫資產，並且處於生物仿製藥和數字健康的 III 期，但我認為公司定位良好。最好在某個階段有其他人來支持董事會並基本上 [重新審視] 假設。所以我認為這對所有相關人員都有好處。我的重點將再次放在公司上。這不是關於我的。這關乎公司、團隊和平穩過渡。生意還在繼續。未來幾天，我將在紐約波士頓親自與大家會面。

I will be traveling with my team in Asia at the end of the week to meet our key partners and potential future partners and support our team and meet with PMDA also. So the business continues, and I will be at the top of it until the last second.

我將在本週末與我的團隊一起前往亞洲，與我們的主要合作夥伴和潛在的未來合作夥伴會面，並支持我們的團隊並與 PMDA 會面。所以生意還在繼續，直到最後一秒我都將處於領先地位。

We will now take our next question from Umer Raffat from Evercore.

我們現在將回答來自 Evercore 的 Umer Raffat 的下一個問題。

I guess I'll focus on cost for a second. And I guess I'm just trying to get at what is the actual cost savings? I'm partially confused because SG&A guidance was cut, but -- sorry, SG&A was cut, but the overall guidance was unchanged. Or maybe just a simple way to think about it is where are we truly headed on OpEx over the next coming medium term? Because I just think back to when I first started covering Biogen, you were a leader in MS, you had over $4 billion in marketed MS revenues, but the SG&A was only $1 billion. Now the market at MS revenue is $5 billion, meaning a little higher. But the SG&A is $2.5 billion. And of course, you have some biosimilars and SPINRAZA. And I'm not necessarily saying $2.5 billion goes down to $1 billion, but can we see a substantial SG&A rebasing of the business?

我想我會先關註一下成本。我想我只是想知道實際節省的成本是多少？我有些困惑，因為 SG&A 指導被削減了，但是 - 抱歉，SG&A 被削減了，但整體指導沒有改變。或者也許只是一種簡單的思考方式，即在下一個即將到來的中期，我們在運營支出方面真正走向何方？因為我回想起我剛開始報導百健（Biogen）的時候，你是 MS 的領導者，你的 MS 銷售收入超過 40 億美元，但 SG&A 只有 10 億美元。現在微軟市場的收入是 50 億美元，這意味著更高一些。但SG&A是25億美元。當然，您還有一些生物仿製藥和 SPINRAZA。我並不是說 25 億美元會下降到 10 億美元，但我們能否看到業務的 SG&A 大幅調整？

Yes, Umer, it's Mike. Thank you for the question. So the cost savings that we mentioned today, the additional $500 million run rate, that will be largely tied to the ADUHELM infrastructure. And we talked about that on our last call that we had initially expected about a $400 million number in 2022. And so obviously, that will be cut substantially. So in the SG&A guide where we took that down by about $200 million, that largely is a significant piece of it. Beyond that, we will obviously look at some of the non-revenue facing pieces in G&A and others in order to achieve that run rate.

是的，烏默爾，是邁克。感謝你的提問。因此，我們今天提到的成本節約，即額外的 5 億美元運行率，主要與 ADUHELM 基礎設施相關。我們在上次電話會議上談到了這一點，我們最初預計 2022 年的數字約為 4 億美元。顯然，這將被大幅削減。因此，在 SG&A 指南中，我們將其減少了約 2 億美元，這在很大程度上是其中的重要組成部分。除此之外，我們顯然會研究 G&A 和其他方面的一些非收入部分，以實現該運行率。

And as we've said in our prepared remarks, we may invest certain portions of that $500 million in savings into the -- into future growth initiatives with the overall priority being to return to growth. I will say in closing that as it relates to guidance, we were able to reaffirm our guidance, notwithstanding the inventory write-offs and the currency headwinds that we were facing. And that was really a result of 2 things. One is the cost initiatives, and then the second was that the top line has performed a little bit better than what we had originally expected at the beginning of the year.

正如我們在準備好的評論中所說，我們可能會將這 5 億美元的儲蓄中的某些部分投資到未來的增長計劃中，總體優先事項是恢復增長。最後我要說的是，由於它與指導有關，我們能夠重申我們的指導，儘管我們面臨庫存沖銷和貨幣逆風。這實際上是兩件事的結果。一是成本舉措，二是收入的表現比我們年初預期的要好一些。

And I would point to SPINRAZA MS as well as the CD20s being a little bit stronger than expected, and that impact between the cost savings and the revenue. It's about half and half that contribute to our ability to hold the EPS in the same place. So we'll continue to take necessary cost measures to align with the revenue trajectory of the business. And hopefully, that's some helpful color.

我會指出 SPINRAZA MS 和 CD20 比預期的要強一點，以及成本節約和收入之間的影響。大約一半有助於我們將 EPS 保持在同一位置。因此，我們將繼續採取必要的成本措施，以符合業務的收入軌跡。希望這是一些有用的顏色。

And a couple of comments to consider, Umer. The first one is that at that time where you started to cover, it was mostly U.S. business only, okay? And this is not the case today. And the second point is that there were very few (inaudible) in the class, and now it's extremely crowded, and Biogen is still the leader globally in each one of those being SMA, being MS and being anti-TNF in Europe. So this takes some muscles and, obviously, skills. And we have made tremendous progress in terms of using digitalization and all the means of engaging, but we get the point, and this is compounded by the investment we have made on ADUHELM that we're eliminating.

烏默爾，還有幾點需要考慮的評論。第一個是在你開始報導的時候，主要是美國業務，好嗎？而今天的情況並非如此。第二點是班裡的人很少（聽不清），現在非常擁擠，百健（Biogen）在歐洲的 SMA、MS 和抗 TNF 方面仍然是全球領導者。所以這需要一些肌肉，顯然還需要技巧。我們在使用數字化和所有參與手段方面取得了巨大進步，但我們明白了這一點，而且我們在 ADUHELM 上進行的投資使我們正在消除這一點。

We will now take our next question from Robyn Karnauskas from Truist Securities.

我們現在將向 Truist Securities 的 Robyn Karnauskas 提出我們的下一個問題。

So the first one was just for Priya. You had talked about how new data showing lecanemab. When you stop it, it suggests that you could have some decline [in cognition]. Can you just talk about any more updates as to why you think that is? And if you think there's a difference in the mechanism versus Lilly's drug? Another thing you mentioned, you did mention also about potentially divesting products. I wanted to know if you could elaborate on what you're referring to.

所以第一個只是給普里亞的。您曾談到新數據如何顯示 lecanemab。當你停止它時，它表明你[認知]可能會有所下降。你能談談你認為這是為什麼的更多更新嗎？如果你認為機制與禮來的藥物有區別？你提到的另一件事，你確實也提到了潛在的剝離產品。我想知道您是否可以詳細說明您所指的內容。

Priya?

普里亞？

Yes. Thank you for that question. So first of all, let me touch upon lecanemab. I think that the data that I referred to is data from the gap period in the open label, which was followed by the open-label extension in the Phase II study. And I think what it shows you is that the science on this aspect of what is the ideal treatment duration is emerging. And that's really the point that we need to kind of take away from this. So the field is evolving. There were 2 biomarkers, Abeta 42/40 ratio as well as plasma phospho-tau 181. And we saw a reversal in both in the wrong direction.

是的。謝謝你的問題。首先，讓我談談 lecanemab。我認為我提到的數據是來自開放標籤中的空白期的數據，隨後是 II 期研究中的開放標籤擴展。而且我認為它向您展示的是，關於理想治療持續時間這方面的科學正在出現。這確實是我們需要擺脫這一點的重點。所以這個領域正在發展。有 2 個生物標誌物，Abeta 42/40 比率以及血漿 phospho-tau 181。我們看到兩者都朝著錯誤的方向逆轉。

So I think that how we are trying to address this is Eisai is actually taking a lead on it because they are assessing how maintenance can be applied, and they are doing this in their open-label extension in the Phase II study. So there's more data probably that will read out in the upcoming period as they learn more. And I think with donanemab, you asked me for a comparison, I can only speak to the data that I've seen in the public domain. And I think that what we haven't seen is the aftereffects of long-term follow-up. We haven't seen a similar effect of what happens to amyloid plaques or what happens to phospo-tau once lecanemab is stopped. And I think that, that data would be relevant for us to make a fair comparison.

因此，我認為我們試圖解決這個問題的方式是衛材實際上在這方面處於領先地位，因為他們正在評估如何應用維護，並且他們在 II 期研究的開放標籤擴展中這樣做。因此，隨著他們了解更多，可能會在未來一段時間內讀出更多數據。而且我認為對於 donanemab，您要求我進行比較，我只能談論我在公共領域看到的數據。而且我認為我們沒有看到的是長期隨訪的後遺症。我們還沒有看到澱粉樣斑塊發生的情況或 lecanemab 停止後 phospo-tau 發生的情況的類似影響。而且我認為，這些數據對於我們進行公平比較是相關的。

At the moment, I think what we believe, along with Eisai and what we see, is that stopping prematurely can cause a reversal. So hopefully, that answers that part of the question. And then the second part of your question was about divestiture. And I'll just step back and say that we are looking across our entire portfolio, our R&D portfolio and making integrated decisions on prioritization. What do I mean by this? I mean that we're looking at our disease areas, we're looking at our therapeutic areas, we're looking at where we are leaders, where we have a lot of internal expertise, and we are prioritizing accordingly and being good stewards of resources.

目前，我認為我們相信，以及衛材和我們所看到的，過早停止會導致逆轉。因此，希望這可以回答問題的一部分。然後你問題的第二部分是關於資產剝離。我會退後一步說，我們正在審視我們的整個產品組合，我們的研發產品組合，並就優先級做出綜合決策。我這是什麼意思？我的意思是，我們正在研究我們的疾病領域，我們正在研究我們的治療領域，我們正在研究我們在哪裡是領導者，我們在哪裡擁有很多內部專業知識，我們正在相應地優先考慮並成為良好的管家資源。

So this is also driven in part by internal and external readouts. For example, we've just filed for zuranolone. This is a very exciting step for us in neuropsychiatry and we are expecting an upcoming readout for BIIB104, which is for cognitive impairment associated with schizophrenia. So we'll see what that readout shows us. But again, we will anchor to areas where we have success, we have expertise and build around those areas. The same goes for lupus. We have 3 programs in lupus, and we will continue to build out those areas as we see readouts and data. We may also consider expansion of indications.

因此，這也部分由內部和外部讀數驅動。例如，我們剛剛申請了 zuranolone。這對我們在神經精神病學方面來說是非常令人興奮的一步，我們期待即將發布的 BIIB104 讀數，該讀數用於與精神分裂症相關的認知障礙。因此，我們將看到該讀數向我們展示了什麼。但同樣，我們將立足於我們成功的領域，我們擁有專業知識並圍繞這些領域進行建設。狼瘡也是如此。我們有 3 個狼瘡項目，我們將在看到讀數和數據時繼續擴大這些領域。我們也可以考慮擴大適應症。

So everything is really on the table and we're trying to be very disciplined about an integrated prioritization and methodology. Now within that integrated prioritization, we may have assets where we believe that they may have -- be better utilized by partnering them or by externalizing them. This is what I meant by divest. So hopefully, that addresses it. It's just one part of a much larger, synchronized, integrated R&D strategy.

因此，一切都擺在桌面上，我們正在努力對整合的優先級和方法進行非常嚴格的約束。現在，在這個綜合優先級中，我們可能擁有我們認為他們可能擁有的資產——通過與他們合作或通過將它們外部化來更好地利用它們。這就是我所說的剝離。所以希望能解決這個問題。這只是更大的、同步的、集成的研發戰略的一部分。

Pardon the interruption, ladies and gentlemen, we are experiencing a momentary interruption. Just bear with us. Thank you. Thank you, sir. We will now take our next question from Salveen Richter from Goldman Sachs.

請原諒打擾，女士們，先生們，我們正在經歷短暫的打擾。請忍受我們。謝謝你。謝謝你，先生。我們現在將向高盛的 Salveen Richter 提出下一個問題。

In terms of your capital allocation strategy to drive growth, how much of a priority is business development?

就您推動增長的資本配置策略而言，業務發展的優先級有多少？

Salveen, Mike McDonnell, and thank you very much for the question. Business development has been and continues to be a priority. And we have a pipeline that we feel good about, and we will continue to look to supplement that through business development transactions as we have done in the past. And at the same time, we will continue to return capital to shareholders. So it will continue to be a balance and business development has been and will continue to be a priority.

Salveen、Mike McDonnell，非常感謝您的提問。業務發展一直並將繼續成為優先事項。我們有一條我們感覺良好的管道，我們將繼續尋求通過業務發展交易來補充這一點，就像我們過去所做的那樣。同時，我們將繼續向股東返還資金。因此，它將繼續保持平衡，業務發展一直並將繼續成為優先事項。

We will now take our next question from Michael Yee from Jefferies.

我們現在將向 Jefferies 的 Michael Yee 提出我們的下一個問題。

Following up on Michel and Priya's comments around R&D portfolio prioritization, is it safe to say that you would consider anything on the table in terms of divesting, partnering, out-licensing, bringing in stuff, but just the concept that anything is on the table with regards to even including product lines or franchises that the whole portfolio and always is all on the table. Can you clarify that?

跟進 Michel 和 Priya 關於研發組合優先級的評論，是否可以肯定地說，您會考慮在剝離、合作、許可外許可、引進方面的任何事情，但只是任何事情都在桌面上的概念關於甚至包括整個產品組合併且始終都在桌面上的產品線或特許經營權。你能澄清一下嗎？

Thank you, Michael. Yes, I would say that across the Board, we are going to be driven by science and integration and maximizing the value that we bring to patients with diseases of high unmet need. So I think we would evaluate all options. But I think the science has to be the driver, and that's how we would do the evaluations. So yes, exactly as you said.

謝謝你，邁克爾。是的，我想說的是，全面而言，我們將受到科學和整合的驅動，並最大限度地提高我們為患有高度未滿足需求的疾病患者帶來的價值。所以我認為我們會評估所有選項。但我認為科學必須成為驅動力，這就是我們進行評估的方式。所以是的，正如你所說。

Would you include commercialization businesses and franchises as well?

您是否也包括商業化業務和特許經營權？

Potentially for some, but not for all. I think that Biogen will remain on the upper hand on a few priorities, but we'll be open to look for partnering on others. But it's for Priya and the team to determine with the support of the governance of the company.

可能對一些人來說，但不是對所有人。我認為百健（Biogen）將在一些優先事項上保持優勢，但我們將樂於尋找其他方面的合作夥伴。但在公司治理的支持下，這是由 Priya 和團隊決定的。

We will now take our next question from Cory Kasimov from JPMorgan.

我們現在將向摩根大通的 Cory Kasimov 提出我們的下一個問題。

I'm curious, what is significantly scaling back ADUHELM's commercial infrastructure, say, if anything, about your expectations for the Phase III lecanemab data? Or is it simply too long to wait until you get full approval even if lecanemab is successful in Clarity AD? And along those lines, can you remind us of how your responsibilities for commercialization on that front might be any different than with ADUHELM?

我很好奇，是什麼在顯著縮減 ADUHELM 的商業基礎設施，比如說，如果有的話，關於您對 III 期 lecanemab 數據的期望？或者，即使 lecanemab 在 Clarity AD 中取得成功，等到您獲得完全批准是否太久？沿著這些思路，您能否提醒我們您在這方面的商業化責任可能與 ADUHELM 有何不同？

So we do expect the Phase III readout in the fall of this year. And we are discussing in full alignment with a partner, the operational details beyond lecanemab. But based on the timing, it will make no sense to carry such a long team -- such a large team for such a long time. So I think it's the right decision. The preparation that was made on the infrastructure is there, and there is certainly a big benefit for the entire class moving forward. But we could not afford to keep the team, unfortunately, for that many months. So I think it's the right decision. Our sentiment for lecanemab does not change, just to be clear.

因此，我們確實希望在今年秋季發布第三階段讀數。我們正在與合作夥伴完全一致地討論 lecanemab 之外的操作細節。但從時間上看，攜帶這麼長的一支隊伍是沒有意義的——這麼長的一支隊伍。所以我認為這是正確的決定。在基礎設施上所做的準備工作就在那裡，這對整個班級的前進肯定有很大的好處。但不幸的是，我們無法將球隊留住那麼幾個月。所以我認為這是正確的決定。我們對 lecanemab 的看法沒有改變，只是為了清楚。

We will now take our next question from Marc Goodman from SVB.

我們現在將向 SVB 的 Marc Goodman 提出下一個問題。

Just to continue on with the R&D topic. I think the view from the outside world has been that the pipeline has always been a little bit high risk, high reward, and that's probably not that surprising just because this is CNS. But now that you're going to take a look at the pipeline and really kind of change the way you're viewing things, how much does that change, factor into whether you start to diversify more away from CNS? And if you're going to stay within CNS mostly, how do you change the probability of success projects to lower risk projects? And how do you do all of this change, given that there's also a management change going on? And how much Board is supportive, and I think you understand the context of the question.

只是繼續研發主題。我認為外界的看法是，管道一直是有點高風險、高回報的，這可能並不奇怪，因為這是 CNS。但是現在你要看看管道並真正改變你看待事物的方式，這種變化有多大，影響你是否開始更多地遠離 CNS？如果您主要留在 CNS 中，您如何將項目成功的概率更改為風險較低的項目？考慮到管理層也在發生變化，你如何進行所有這些變化？董事會有多少支持，我想你理解這個問題的背景。

Yes, absolutely. And I think it's a very important question. It's all about having the right priorities and somehow rebalancing the risk profile of the portfolio. And we know that. And this goes with neuroscience, but Priya will say more.

是的，一點沒錯。我認為這是一個非常重要的問題。這一切都是為了擁有正確的優先事項並以某種方式重新平衡投資組合的風險狀況。我們知道這一點。這與神經科學有關，但普里亞會說更多。

Yes. Thank you, Marc. It's a really pertinent question here. So I think the 2 -- it's a 2-pronged approach. Number one, we're going to be driven by the science. We're going to stay within neuroscience. So I think at this point, I want to be very clear that we stay within neuroscience. It's a very important part of our expertise, our talent pool, and we are continuing to build on our strengths there. But we are definitely open to adjacencies. We've already demonstrated, for example, as I mentioned with the zuranolone filing and with the 104 readout coming on its heels.

是的。謝謝你，馬克。這是一個非常相關的問題。所以我認為 2 - 這是一個雙管齊下的方法。第一，我們將被科學驅動。我們將留在神經科學領域。所以我認為在這一點上，我想非常清楚我們留在神經科學領域。這是我們的專業知識和人才庫中非常重要的一部分，我們將繼續在這方面發揮我們的優勢。但我們絕對對鄰接持開放態度。例如，正如我提到的 zuranolone 申請和緊隨其後的 104 讀數，我們已經證明了這一點。

In addition, I think that we are working in lupus. So that's a specialized immunology field. And we may consider other indications, we may consider other potential opportunities in the space. So that's one way in which we would diversify and rebalance our risk. Because as you know, the probability of technical and regulatory success changes as you move out of neuroscience. But given our core expertise of neuroscience and all the learnings we've had; we believe we have a lot of asymmetrical knowledge in the space. And in that space, we are continuing to enhance our probability of success, maximize it, in fact, by building on our strengths in biomarkers, clinical development, functional genomics, human validation.

另外，我認為我們正在治療狼瘡。這是一個專門的免疫學領域。我們可能會考慮其他跡象，我們可能會考慮該領域的其他潛在機會。因此，這是我們分散和重新平衡風險的一種方式。因為如您所知，隨著您離開神經科學，技術和監管成功的可能性會發生變化。但是鑑於我們在神經科學方面的核心專業知識以及我們所學到的所有知識；我們相信我們在這個領域有很多不對稱的知識。在那個領域，我們正在繼續提高我們成功的可能性，事實上，通過建立我們在生物標誌物、臨床開發、功能基因組學、人體驗證方面的優勢。

So we believe that these are the methodologies, which will help us sort of increase our probability of success and give us the ability to deliver on proof of concepts. So it's a two-pronged strategy. And add to that our 4 pillars, which you already know about, biosimilars and digital health. We're also looking at integration, right, with digital options. So this really goes beyond a very narrow focus. It looks at the portfolio in totality and the value that the portfolio brings in totality. And it's -- we have the expertise in terms of modalities. We have all modalities available to us.

因此，我們相信這些是方法論，它們將幫助我們提高成功的可能性，並使我們能夠交付概念證明。所以這是一個雙管齊下的策略。除此之外，您還知道我們的 4 大支柱，即生物仿製藥和數字健康。我們也在考慮與數字選項的集成，對吧。所以這真的超出了一個非常狹窄的焦點。它著眼於整體投資組合以及投資組合帶來的整體價值。它是——我們在模式方面擁有專業知識。我們擁有所有可用的方式。

So we're looking at targets, and we're looking at the best modality. We're not looking at modalities and how do we kind of exploit those. We're looking at it in the reverse way. We're looking at disease target and then what's the best modality to go forward with. I hope that gives you a bit of a glimpse of how we're approaching this. Thank you. Can I just address the last part I meant to add that you asked about how we would do this in a Board setting, in a management setting? I want to say that I have a lot of authority currently, and I am making decisions on prioritization. So that, I hope, will go forward.

所以我們正在尋找目標，我們正在尋找最好的方式。我們不關注模式以及我們如何利用這些模式。我們以相反的方式看待它。我們正在研究疾病目標，然後是什麼是最好的推進方式。我希望這能讓您大致了解我們是如何處理這個問題的。謝謝你。我可以直接談談我要補充的最後一部分，你問我們如何在董事會環境中做到這一點，在管理環境中？我想說我目前有很多權力，我正在決定優先級。所以，我希望，將繼續前進。

We will now take our next question from Brian Abrahams from RBC Capital Markets.

我們現在將向加拿大皇家銀行資本市場的布萊恩亞伯拉罕提出下一個問題。

Best wishes to Michel with the transition. What's your latest sense of the FDA stance on accelerated approval for beta amyloid antibodies, just with some of the changes in leadership and initiatives at the agency? And then I know the FDA has agreed that Clarity AD could serve as a confirmatory study following accelerated approval of lecanemab. But can you clarify if you don't receive accelerated approval, whether that Phase III could stand on its own to support full approval or whether you need an additional study?

在過渡期間向 Michel 致以最良好的祝愿。您對 FDA 對加速批准 β 澱粉樣蛋白抗體的最新立場有何看法，以及該機構領導層和舉措的一些變化？然後我知道 FDA 已經同意在 lecanemab 加速批准後，Clarity AD 可以作為驗證性研究。但是你能否澄清一下如果你沒有獲得加速批准，第三階段是否可以獨立支持完全批准，或者你是否需要額外的研究？

Thank you for the comments. Priya?

謝謝你的意見。普里亞？

Thank you. So I'll just step back, Brian, and say that accelerated approval pathway is a very, very highly rigorous and scientific regulatory pathway. It's existed for several years now. And several products have come through the pathway and many patients around the United States have benefited from this access. So I know that there's a lot of dialogue, and I'm reading the same as you are. But I don't believe that at any point right now, there is going to be a potential major shift. There could be enhancements, there could be sort of refinements. I'm sure that could happen to any regulatory pathway as more learnings are obtained. But I don't believe that our confidence has been shaken in the accelerated approval pathway. It remains a critical way in which you can bring products to patients who really need them today. So that's number one.

謝謝你。所以我會退後一步，布賴恩，並說加速批准途徑是一個非常、非常嚴格和科學的監管途徑。它已經存在了好幾年了。一些產品已經通過這條途徑，美國各地的許多患者都從這種途徑中受益。所以我知道有很多對話，我讀的和你一樣。但我不相信現在任何時候都會發生潛在的重大轉變。可能會有增強，可能會有一些改進。我敢肯定，隨著獲得更多知識，任何監管途徑都可能發生這種情況。但我不認為我們對加速審批途徑的信心已經動搖。它仍然是您可以將產品帶給當今真正需要它們的患者的一種關鍵方式。所以這是第一名。

Number two, I'll say that with Clarity AD, the strategy has been -- and I think this has been publicly communicated by Eisai and us, so I'm just quoting that, that they have filed base -- initiated the filing based on the Phase II study, as you know. And that is via the accelerated approval pathway. There is agreement from the FDA, and Eisai has commented on this publicly as well, that Clarity AD could serve as a confirmatory study. Now to your question that what if the Clarity AD is unclear or ambiguous, could they still get approval, could we still get approval? I think that would be very speculative for me to comment on. What I think would be a reasonable way forward, depending on the data, would be to have that discussion with the FDA. Because the science here is complex, as we've seen. And I think the most important thing is to continue to evaluate the science and the data as it emerges and assess what is the strength of evidence. And I think that is really what is going to make the difference in this case.

第二，我要說的是，對於 Clarity AD，該策略是——我認為衛材和我們已經公開傳達了這一點，所以我只是引用他們已經提交了基礎——啟動了基於如您所知，在 II 期研究中。那是通過加速批准途徑。 FDA 同意，衛材也對此公開發表評論，Clarity AD 可以作為驗證性研究。現在你的問題是，如果 Clarity AD 不清楚或模棱兩可，他們還能獲得批准嗎？我們還能獲得批准嗎？我認為這對我來說是非常投機的評論。根據數據，我認為合理的前進方式是與 FDA 進行討論。因為正如我們所見，這裡的科學很複雜。我認為最重要的是繼續評估出現的科學和數據，並評估證據的強度。而且我認為這確實會在這種情況下產生影響。

We will now take our next question from (inaudible) from Bank of America.

我們現在將向美國銀行（聽不清）提出我們的下一個問題。

I just wanted to jump on to other questions on lecanemab and just wanted to know, strategically, how important is having a robust Alzheimer's pipeline to you guys? I mean, when you look at the infrastructure that you have from an R&D perspective, clearly, there are lessons to be learned from adu. But I wanted to ask you, is there an opportunity or is there a potential to bring in other assets behind lecanemab to kind of further expand the Alzheimer's piece?

我只是想跳到關於 lecanemab 的其他問題，只是想從戰略上知道，擁有強大的阿爾茨海默氏症管道對你們來說有多重要？我的意思是，當您從研發的角度看待您擁有的基礎設施時，很明顯，我們可以從 adu 中吸取教訓。但我想問你，是否有機會或有可能引入 lecanemab 背後的其他資產來進一步擴大阿爾茨海默氏症的範圍？

Thank you. I think that first of all, we remain committed to Alzheimer's disease. And lecanemab is -- we are very privileged and honored to have 2 Abeta removal agents. Aducanumab, we still continue to invest in EMBARK and ENVISION. We think that these will have potentially very critical scientific data that can impact not only the product but also the field. So that remains very important. We continue to invest in early Alzheimer's disease programs. As I mentioned, we have a BIIB080, which is our anti-tau ASO, and then we have BIIB113, which is an OGA inhibitor. Very different sort of approaches to tau pathology.

謝謝你。我認為首先，我們仍然致力於阿爾茨海默病。 lecanemab 是——我們非常榮幸和榮幸擁有 2 種 Abeta 去除劑。 Aducanumab，我們仍在繼續投資 EMBARK 和 ENVISION。我們認為，這些將具有潛在的非常關鍵的科學數據，這些數據不僅會影響產品，還會影響該領域。所以這仍然非常重要。我們繼續投資於早期阿爾茨海默病項目。正如我所提到的，我們有一個 BIIB080，它是我們的抗 tau ASO，然後我們有 BIIB113，它是一種 OGA 抑製劑。 tau 病理學的非常不同的方法。

So this remains very important. We have other assets which have yet unnamed pathways and targets, which I can't speak about, but there are many, many others as well. So we remain committed to Alzheimer's disease. We are definitely taking all our learnings from the scientific approach, but also on how we would approach clinical development. So we are continuing to strengthen our clinical development expertise in the area. Would we be open to other assets? Yes, we continue to look and scour the external opportunities. At any given time, we are looking at many assets. And again, as I've said, the science will drive the way. The science and the value will continue to drive the way. So that's -- I would say, yes, we are absolutely interested, and we continue to remain highly, highly committed to Alzheimer's disease. Thank you.

所以這仍然非常重要。我們還有其他資產尚未命名的途徑和目標，我不能說，但還有很多很多其他的。所以我們仍然致力於阿爾茨海默病。我們肯定會從科學方法中吸取所有的教訓，同時也從我們將如何進行臨床開發中吸取教訓。因此，我們將繼續加強我們在該領域的臨床開發專業知識。我們會對其他資產持開放態度嗎？是的，我們繼續尋找和挖掘外部機會。在任何給定時間，我們都在關注許多資產。再一次，正如我所說，科學將引領潮流。科學和價值將繼續引領潮流。所以這就是 - 我會說，是的，我們絕對感興趣，我們將繼續高度、高度地致力於阿爾茨海默病。謝謝你。

We will now take our next question from Jay Olson from Oppenheimer.

我們現在將向奧本海默的傑伊奧爾森提出我們的下一個問題。

Thanks to Michel for his constant dedication to patients. My question is about the balance sheet. And if you were to pursue a larger business development transaction, how much debt would you be willing to take on?

感謝 Michel 對患者的不斷奉獻。我的問題是關於資產負債表的。如果您要進行更大的業務發展交易，您願意承擔多少債務？

Jay, it's Mike. Thanks for the question. And I think that when you look at our balance sheet, we're in a very good place. We ended the quarter with $4.8 billion of cash. We received another $1 billion from Samsung in April. So we've got the better part of $6 billion of cash on hand. And when you look at our current debt levels, we're at 2 turns of EBITDA and gross debt and less than 1 turn net debt. So if you hypothetically added a turn of debt, not saying we wouldn't, but it's a hypothetical, that's about $8 billion worth of capacity that we have. And I think that our goal is to deploy that as accretively as we can with the #1 goal being to bring ourselves back to growth over time.

傑，是邁克。謝謝你的問題。而且我認為，當您查看我們的資產負債表時，我們處於一個非常好的位置。我們以 48 億美元的現金結束了本季度。 4 月份，我們又從三星收到了 10 億美元。因此，我們手頭有 60 億美元現金中的大部分。當您查看我們當前的債務水平時，我們的 EBITDA 和總債務為 2 倍，而淨債務則不到 1 倍。因此，如果您假設增加了一筆債務，並不是說我們不會，而是假設，我們擁有的產能價值約為 80 億美元。我認為我們的目標是盡可能增加地部署它，第一目標是隨著時間的推移讓自己恢復增長。

We've done about 30 deals and deployed about $6.5 billion in business development over the last 5.5 years. We will continue to prioritize business development along with returning capital to shareholders. It will be a balance. And I would say that we do have capacity for some incremental debt, but we've got so much cash on hand right now that adding debt is not something that we would obviously be needing or looking to do in the near term. So hopefully, that's helpful.

在過去的 5.5 年裡，我們已經完成了大約 30 筆交易，並在業務開發中部署了大約 65 億美元。我們將繼續優先考慮業務發展以及向股東返還資本。這將是一個平衡。我想說我們確實有能力承擔一些增量債務，但我們現在手頭有這麼多現金，所以增加債務顯然不是我們短期內需要或希望做的事情。所以希望這會有所幫助。

We will now take our next question from Phil Nadeau from Cowen & Company.

我們現在將向 Cowen & Company 的 Phil Nadeau 提出我們的下一個問題。

Mine is a follow-on to Brian's on the Clarity AD study. Could you talk in a bit more detail about the design of the trial, in particular, what's the powering on the primary endpoint of CDR-Sum of Boxes? What is a clinically meaningful difference between drug and placebo and CDR-SB? And then in terms of the p-value, if this is a single-Phase III study, what p-value is necessary for success? Is 0.05 sufficient? Or do you need 0.01?

我的文章是 Brian 關於 Clarity AD 研究的後續文章。您能否更詳細地談談試驗的設計，特別是 CDR-Sum of Boxes 的主要終點是什麼？藥物與安慰劑和 CDR-SB 之間的臨床意義差異是什麼？然後就 p 值而言，如果這是一項單階段 III 研究，成功所需的 p 值是多少？ 0.05 就足夠了嗎？或者你需要0.01？

Thank you. So first of all, Clarity AD, we haven't spoken externally about the powering of the study, but Eisai has commented on it. In the Phase II study, we had several arms and the outcome [wasn't powered] for CDR-Sum of Boxes. That is actually very different. Phase II has informed how Phase III has been designed and it is powered to detect a statistically significant difference on CDR-Sum of Boxes. So that's one aspect I wanted to cover. The second is that CDR-Sum of Boxes, we believe, is the right primary endpoint for this patient population and for the MCI in early Alzheimer's disease.

謝謝你。所以首先，Clarity AD，我們沒有對外談論這項研究的動力，但衛材對此發表了評論。在 II 期研究中，我們有幾個研究組，結果 [未提供動力] 用於 CDR-Sum of Boxes。這實際上是非常不同的。第二階段已經告知第三階段是如何設計的，並且它能夠檢測到 CDR-Sum of Boxes 的統計顯著差異。這就是我想要涵蓋的一個方面。第二個是我們認為，CDR-Sum of Boxes 是該患者群體和早期阿爾茨海默病 MCI 的正確主要終點。

This has cognitive and functional elements. We believe that it is the most relevant primary endpoint. And we feel that we are fairly confident in the design of the study to kind of give us the outcome. Now what kind of p-value is very hard, I would be speculating, so I won't speculate here. But we feel that the study is designed appropriately and that the results would be important to review. I think in terms of clinical meaningfulness, we have done a lot of work ourselves. There's a lot of external dialogue. And we do believe that, honestly, the EMERGE data that we had with the 22% difference is highly clinically relevant and clinically meaningful to [KMEs] and to patients. So we've done a lot of work around this. And I'm sure you've seen that in the public domain. Beyond that, I don't think I can comment on it.

這具有認知和功能元素。我們認為這是最相關的主要終點。我們覺得我們對研究的設計相當有信心，可以給我們帶來結果。現在什麼樣的p值是非常難的，我會推測，所以我不會在這裡推測。但我們認為這項研究設計得當，而且結果對審查很重要。我認為在臨床意義方面，我們自己做了很多工作。有很多外部對話。而且我們確實相信，老實說，我們擁有的 EMERGE 數據具有 22% 的差異，對 [KME] 和患者俱有高度的臨床相關性和臨床意義。所以我們圍繞這個做了很多工作。我相信你已經在公共領域看到了這一點。除此之外，我認為我無法對此發表評論。

Operator, I think we have time for one final question.

接線員，我想我們有時間回答最後一個問題。

We will now take our final question from Mohit Bansal from Wells Fargo.

我們現在將向富國銀行的 Mohit Bansal 提出最後一個問題。

Maybe a question for Mike. So just -- just trying to understand your comments on share repurchases. So given that the cash flow of the company is not as good as it used to be a couple of years back, and maybe a need for diversification or buying more assets, why share repurchases at this point are a priority in your list?

也許是邁克的問題。所以只是 - 只是想了解您對股票回購的評論。因此，鑑於公司的現金流不如幾年前那麼好，並且可能需要多元化或購買更多資產，為什麼此時股票回購是您的優先事項？

Yes. So thank you for the question, Mohit. And obviously, we did not buy any shares back during the quarter, and you shouldn't be looking quarter-to-quarter because that can vary depending on what we have in the way of business development activity, timing of windows, other considerations, et cetera. But we do expect to utilize a portion of the $2.8 billion that remains throughout the remainder of 2022, and we continue to believe that our stock is a good investment. But at the same time, you obviously will not see us repurchasing shares at the pace that you saw back 2, 3, 4 years ago because of the situation with TECFIDERA and RITUXAN, but we do continue to see it as a good investment and it will be a balance between [BD] and share repurchase as we go. But we'll be smart and balanced about it. And our capital allocation, as we mentioned, is one of our key operational priorities as we look forward throughout the rest of 2022.

是的。所以謝謝你的問題，Mohit。顯然，我們在本季度沒有回購任何股票，您不應該逐季度查看，因為這可能取決於我們在業務發展活動方式、窗口時間安排、其他考慮因素方面的情況，等等。但我們確實希望利用 2022 年剩餘時間剩餘的 28 億美元中的一部分，我們仍然相信我們的股票是一筆不錯的投資。但與此同時，由於 TECFIDERA 和 RITUXAN 的情況，您顯然不會看到我們以您在 2、3、4 年前看到的速度回購股票，但我們確實繼續將其視為一項良好的投資，而且將在[BD]和股票回購之間取得平衡。但我們會對此保持聰明和平衡。正如我們所提到的，我們的資本分配是我們在 2022 年剩餘時間內展望的關鍵運營優先事項之一。

And that concludes our call for today. Thank you, everyone, for joining us.

我們今天的呼籲到此結束。謝謝大家加入我們。

Thank you. That concludes today's conference call. Thank you for your participation. Ladies and gentlemen, you may now disconnect.

謝謝你。今天的電話會議到此結束。感謝您的參與。女士們，先生們，你們現在可以斷開連接了。