美國安進 (AMGN) 2025 Q4 法說會逐字稿

My name is Julianne, and I will be your conference facilitator today for the Amgen Q4 2025 earnings conference call. (Operator Instructions)

我叫朱莉安，今天我將擔任安進公司 2025 年第四季財報電話會議的主持人。（操作說明）

I would now like to introduce Casey Capparelli, Vice President of Investor Relations. Mr. Capparelli, you may now begin.

現在我謹向大家介紹投資人關係副總裁凱西‧卡帕雷利。卡帕雷利先生，您可以開始了。

Thank you, Julianne. Good afternoon, everyone, and welcome to our fourth-quarter 2025 earnings call. Bob Bradway will lead the call today and be followed by a broader review of our performance by Jay Bradner; Murdo Gordon; and Peter Griffith.

謝謝你，朱莉安娜。各位下午好，歡迎參加我們2025年第四季財報電話會議。今天，鮑勃·布拉德韋將主持電話會議，隨後傑伊·布拉德納、默多·戈登和彼得·格里菲斯將對我們的業績進行更廣泛的回顧。

Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompanied this call. We will also make some forward-looking statements, which are qualified by our Safe Harbor statement. And please note that actual results can vary materially.

在今天的討論中，我們將使用非GAAP財務指標來描述我們的業績，並在本次電話會議的隨附資料中提供了適當的調整表。我們也會做出一些前瞻性陳述，但這些陳述均受我們的「安全港」聲明的限制。請注意，實際結果可能存在很大差異。

Over to you, Bob.

接下來就交給你了，鮑伯。

Okay. Thank you, Casey, and good afternoon, everyone. Thank you for joining us today. Today, we'll cover full year results for 2025 and provide a preview of what to expect from us in 2026.

好的。謝謝你，凱西，大家下午好。感謝您今天蒞臨。今天，我們將介紹 2025 年全年業績，並展望 2026 年的發展前景。

Amgen delivered strong operational performance across the board in 2025. And you can see that in the breadth of our business. Note that 14 of our products achieved blockbuster status with sales of $1 billion or more, 13 products delivered double-digit sales growth, and 18 products achieved record results for us. The strength of that broad portfolio enabled us to post double-digit growth in revenues and earnings per share for 2025.

安進公司在2025年全面實現了強勁的營運業績。從我們業務的廣度就能看出這一點。請注意，我們有 14 款產品銷售額達到 10 億美元或以上，成為爆款產品；13 款產品實現了兩位數的銷售成長；18 款產品為我們創造了創紀錄的業績。憑藉這一廣泛的產品組合，我們實現了 2025 年營收和每股收益兩位數的成長。

Looking to 2026, I would highlight six areas of momentum. Three of these, Repatha, EVENITY, and TEZSPIRE all grew by more than 30% year over year in 2025.

展望 2026 年，我想重點介紹六個發展勢頭強勁的領域。其中三家公司，Repatha、EVENITY 和 TEZSPIRE，在 2025 年的年成長率均超過 30%。

These medicines have a few important things in common. First, they’re highly effective, innovative therapies that address important public health needs. Second, they’re leading products in their fields. And third, while each of these products represents a multi-billion-dollar global franchise already, they address areas of large unmet medical need, where there are millions of patients yet to be treated.

這些藥物有一些重要的共同點。首先，它們是高效、創新的療法，能夠滿足重要的公共衛生需求。其次，它們都是各自領域的領先產品。第三，雖然這些產品本身已代表著數十億美元的全球特許經營權，但它們解決的是尚未滿足的重大醫療需求領域，還有數百萬患者尚未接受治療。

In this sense, they represent growth drivers not just for 2026, but for the rest of the decade.

從這個意義上講，它們不僅是 2026 年的成長動力，也是未來十年剩餘時間的成長動力。

In rare disease, our portfolio generated more than $5 billion in sales in 2025. Here, too, many of our medicines are early in their life cycle and positioned as leaders in their respective categories. Growth has been fueled by reaching new patients, expanding into additional geographies, and launching new indications. We see further opportunity ahead as we scale these therapies.

在罕見疾病領域，我們的產品組合在 2025 年創造了超過 50 億美元的銷售額。同樣，我們的許多藥物仍處於生命週期的早期階段，並在各自的類別中處於領先地位。成長的動力來自於接觸新患者、拓展到更多地區以及推出新的適應症。隨著這些療法的推廣應用，我們看到了更多機會。

UPLIZNA exemplifies this growth opportunity with approvals in IgG4-related disease and generalized myasthenia gravis in 2025. Our innovative oncology portfolio grew at 11% year over year in 2025 driven by our BiTE or bispecific T-cell engager medicines. We're particularly excited about IMDELLTRA which has rapidly become the standard of care in patients with second line or later small cell lung cancer, supported by unprecedented survival benefits.

UPLIZNA 就是這項成長機會的例證，該藥物將於 2025 年獲準用於治療 IgG4 相關疾病和全身性重症肌無力。到 2025 年，我們的創新腫瘤產品組合年增 11%，這主要得益於我們的 BiTE 或雙特異性 T 細胞銜接器藥物。我們對 IMDELLTRA 尤其感到興奮，它已迅速成為二線或更晚期小細胞肺癌患者的標準治療方案，並帶來了前所未有的生存獲益。

We're an industry leader in biosimilars. Our biosimilars portfolio has contributed more than $13 billion in sales since the launch of our first medicine there in 2018. With $3 billion in 2025 sales, this business is an important contributor to our organization and poised for growth with the next wave of biosimilar launches.

我們是生物相似藥產業的領導者。自 2018 年我們在該地區推出第一款藥物以來，我們的生物相似藥產品組合已貢獻了超過 130 億美元的銷售額。預計到 2025 年，該業務的銷售額將達到 30 億美元，是我們組織的重要貢獻者，隨著下一波生物類似藥的上市，該業務有望實現成長。

You can appreciate the depth of our business through the lens of our research and development activities. 2026 will be a year of disciplined data generation from a number of exciting Phase 2 and Phase 3 programs that will pave the way for long-term growth at Amgen.

透過我們的研發活動，您可以深入了解我們業務的深度。 2026年，我們將進行多項令人振奮的第二期和第三期臨床試驗，以嚴謹的資料收集工作，為安進的長期發展奠定基礎。

Our confidence continues to build in MariTide as a differentiated treatment for obesity, type 2 diabetes and obesity-related conditions. In a field featuring dozens of potential daily oral and weekly injectable medicines, MariTide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month, or even quarterly dosing.

我們對 MariTide 作為肥胖症、2 型糖尿病和肥胖相關疾病的差異化治療方案的信心與日俱增。在數十種潛在的每日口服和每週注射藥物中，MariTide 獨樹一幟，成為後期開發階段唯一一種能夠以每月、每兩個月甚至每季度給藥的方式提供強效和良好耐受性的療法，這具有顛覆性的前景。

In addition to MariTide, we remain excited about olpasiran and what it might represent for patients with elevated Lp(a), a heritable risk factor for cardiovascular disease. We see olpasiran as an opportunity to build on our leading positions in cardiometabolic disease.

除了 MariTide 之外，我們仍然對 olpasiran 及其對 Lp(a) 水平升高（一種心血管疾病的遺傳風險因素）患者的潛在意義感到興奮。我們認為olpasiran是一個鞏固我們在心血管代謝疾病領域領先地位的機會。

It shouldn't be lost on any of us that Repatha, olpasiran, and MariTide together would represent a very compelling set of cardiometabolic medicines to expand our leadership in the treatment of serious chronic diseases well into the next decade.

我們都應該清楚，Repatha、olpasiran 和 MariTide 聯合起來將是一套非常有吸引力的心血管代謝藥物，有助於我們在未來十年內繼續鞏固在治療嚴重慢性疾病方面的領先地位。

Beyond the pipeline, there's a great deal of enthusiasm about the convergence of technology and life science. And based on what we're seeing at Amgen, we believe that enthusiasm for convergent innovation is well placed and will have significant impact on how we discover, develop, and commercialize medicines. As always, I thank my Amgen colleagues around the world for supporting our mission to serve patients.

除了管道建設之外，人們對科技與生命科學的融合也充滿熱情。根據我們在安進公司所看到的，我們認為對融合創新的熱情是合理的，並將對我們發現、開發和商業化藥物的方式產生重大影響。一如既往，我感謝安進公司世界各地的同事們對我們服務病患使命的支持。

And with that, let me turn it over to Jay for an update in R&D.

那麼，接下來就交給傑伊，讓他為大家報告研發的最新進展。

Thank you, Bob, and good afternoon, everyone. Fourth quarter capped off a year of strong disciplined execution across R&D. Throughout 2025, we advanced multiple late-stage programs, delivered five key regulatory approvals, and strengthened the evidence base supporting our marketed medicines. Taken together, these contributions demonstrate real scientific rigor and illustrate the breadth of opportunity ahead.

謝謝你，鮑勃，大家下午好。第四季為研發領域全年嚴謹且有效率的執行工作畫上了圓滿的句點。在 2025 年，我們推進了多個後期項目，獲得了五項關鍵監管批准，並加強了支持我們上市藥物的證據基礎。總而言之，這些貢獻展現了真正的科學嚴謹性，並說明了未來廣闊的發展機會。

Let me begin with MariTide, which continues to develop in meaningful and very encouraging ways. The MARITIME Phase 3 program is rapidly advancing with strong enthusiasm from investigators and participants. Both of our Phase 3 chronic weight management studies are fully enrolled and our ASCVD and heart failure outcome studies are progressing well.

首先我想談談 MariTide，它正以有意義且非常令人鼓舞的方式不斷發展。MARITIME 第三階段計畫正在迅速推進，研究人員和參與者都表現出極大的熱情。我們的兩項 3 期慢性體重管理研究均已完成招募，我們的 ASCVD 和心臟衰竭結果研究進展順利。

In parallel, we continue to expand the clinical landscape of MariTide across obesity-related conditions. As we began enrollment of our two Phase 3 sleep apnea studies in adults with and without positive airway pressure therapy. Altogether, we now have six global Phase 3 studies underway with MariTide collectively designed to deliver a comprehensive evidence base.

同時，我們持續拓展 MariTide 在肥胖相關疾病領域的臨床應用。我們開始招募兩位接受或未接受正壓通氣治療的成年人進行兩項 3 期睡眠呼吸中止症研究。目前，我們共有六項針對 MariTide 的全球 3 期研究正在進行中，旨在提供全面的證據基礎。

In addition, as we shared last month, we've completed part two of the MariTide Phase 2 chronic weight management study. We also completed the first 24 weeks of the Phase 2 type 2 diabetes study that enrolled participants with and without obesity. Results from these two studies further increase our confidence the MariTide can represent a new paradigm in obesity, type 2 diabetes, and other obesity-related conditions.

此外，正如我們上個月分享的那樣，我們已經完成了 MariTide 第二階段慢性體重管理研究的第二部分。我們也完成了第 2 型糖尿病 2 期研究的前 24 週，該研究招募了肥胖和非肥胖的參與者。這兩項研究的結果進一步增強了我們對 MariTide 的信心，它能夠代表肥胖症、2 型糖尿病和其他與肥胖相關的疾病的新範式。

We believe MariTide has the potential to expand what's possible for patients, availing an opportunity for monthly or less frequent dosing. MariTide's strong efficacy, infrequent dosing, and excellent tolerability at target dose has the potential to further enhance the patient experience and therefore, treatment persistence, a major unmet need in the field.

我們相信 MariTide 有潛力擴大患者的治療選擇，提供每月一次或更少頻率給藥的機會。MariTide 具有療效顯著、給藥頻率低、目標劑量耐受性好等優點，可望進一步改善患者體驗，從而提高治療的持續性，這是該領域尚未滿足的主要需求。

Beyond obesity and general medicine, the fourth quarter brought a landmark contribution to cardiovascular health for Repatha. In November, full results from the Phase 3 VESALIUS-CV trial were presented at the American Heart Association Scientific session and simultaneously published in the New England Journal of Medicine. This study enrolled more than 12,000 patients without a prior heart attack or stroke, testing the impact of Repatha for LDL-C lowering when added to optimized lipid therapy, namely statins, with a median follow-up of approximately 4.5 years.

除了肥胖症和一般醫學領域，Repatha 在第四季度為心血管健康領域做出了里程碑式的貢獻。11 月，VESALIUS-CV 3 期試驗的完整結果在美國心臟協會科學會議上公佈，並同時發表在《新英格蘭醫學雜誌》上。這項研究納入了 12,000 多名以前沒有心臟病發作或中風的患者，測試了在優化的脂質治療（即他汀類藥物）的基礎上添加 Repatha 對降低 LDL-C 的影響，中位隨訪時間約為 4.5 年。

In VESALIUS-CV, Repatha demonstrated a 25% relative risk reduction in the composite of coronary heart disease death, heart attack or ischemic stroke and delivered a 36% reduction in heart attack with no new safety signals observed. These data clearly demonstrate that intensive LDL-C lowering with Repatha can meaningfully reduce the risk of a first cardiovascular event, reinforcing its role across the full continuum of cardiovascular risk.

在 VESALIUS-CV 研究中，Repatha 使冠心病死亡、心臟病發作或缺血性中風的複合終點相對風險降低了 25%，心臟病發作風險降低了 36%，且未觀察到新的安全訊號。這些數據清楚地表明，使用 Repatha 進行強化 LDL-C 降低可以顯著降低首次心血管事件的風險，從而強化了其在心血管風險全過程中所扮演的角色。

Turning to olpasiran, our potentially best-in-class small interfering RNA medicine targeting Lp(a) the fully enrolled OCEAN(a) outcome study continues to progress. As previously discussed, this is an event-driven study, and the aggregate endpoint accrual rate remains lower than initial predictions. As the study matures, we will update on the date for primary analysis as appropriate. Our conviction in olpasiran to reduce cardiovascular risk conferred by elevated Lp(a) remain strong, grounded in compelling genetic and epidemiologic evidence that establish elevated Lp(a) as an independent risk factor for heart disease.

說到 olpasiran，我們針對 Lp(a) 的可能最好的同類小幹擾 RNA 藥物，已全面招募的 OCEAN(a) 結果研究正在繼續推進。如前所述，這是一項事件驅動型研究，整體終點事件發生率仍低於最初的預測。隨著研究的深入，我們將酌情更新主要分析的日期。我們堅信 olpasiran 可以降低 Lp(a) 升高帶來的心血管風險，這一信念基於令人信服的遺傳學和流行病學證據，這些證據表明 Lp(a) 升高是心臟病的獨立危險因子。

Moving to rare disease. The fourth quarter was highlighted by important regulatory momentum for UPLIZNA. In November, the European Commission approved UPLIZNA for the treatment of adults with active IgG4-related disease. And in December, the FDA approved UPLIZNA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-MuSK antibody positive.

轉向罕見疾病領域。第四季度，UPLIZNA獲得了重要的監管發展動力。11 月，歐盟委員會批准 UPLIZNA 用於治療患有活動性 IgG4 相關疾病的成年人。12 月，FDA 批准 UPLIZNA 用於治療抗乙醯膽​​鹼受體或抗 MuSK 抗體陽性的成人全身性重症肌無力。

These approvals built on strong Phase 3 data, demonstrating durable efficacy, a steroid-sparing benefit with every six-month dosing. This research further extends the impact of CD19-directed B-cell depletion across serious autoimmune diseases.

這些核准是基於強有力的 3 期臨床試驗數據，證明了其持久的療效，以及每六個月給藥一次即可減少類固醇用量的好處。這項研究進一步擴展了 CD19 靶向 B 細胞耗竭對嚴重自體免疫疾病的影響。

More broadly in B cell depletion, where we have a number of proof-of-concept studies underway, we expect to initiate two pivotal studies this year. The first is for patients with autoimmune hepatitis, a serious disease characterized by persistent liver inflammation that can lead to progressive scarring, loss of liver function and ultimately, liver failure.

更廣泛地說，在 B 細胞耗竭領域，我們目前正在進行多項概念驗證研究，預計今年將啟動兩項關鍵研究。第一種情況是針對自體免疫性肝炎患者，這是一種嚴重的疾病，其特徵是持續的肝臟炎症，可導致進行性瘢痕形成、肝功能喪失，最終導致肝衰竭。

The second that is chronic inflammatory demyelinating polyneuropathy, or CIDP, a disabling immune-mediated neuropathy that damages peripheral nerve myelin resulting in worsening strength, worsening sensation, and for many patients, substantial impairment in daily activity.

第二種是慢性發炎性脫髓鞘多發性神經病變，或稱為 CIDP，是一種致殘性免疫介導性神經病變，會損害週邊神經髓鞘，導致肌力下降、感覺減退，對許多患者而言，日常生活活動會受到嚴重損害。

With UPLIZNA, we are targeting these diseases at their root cause by depleting pathologic B cells that drive disease through secreted autoantibodies. Given the strong efficacy of UPLIZNA in other settings, we're excited about the potential to bring a meaningful new option to patients with these two devastating conditions.

透過 UPLIZNA，我們致力於從根本上解決這些疾病，透過清除分泌自體抗體驅動疾病的病理性 B 細胞來實現。鑑於 UPLIZNA 在其他情況下的顯著療效，我們很高興它有可能為患有這兩種毀滅性疾病的患者帶來有意義的新選擇。

We are also advancing dazodalibep, our CD40 ligand targeting biotherapeutic with both Phase 3 studies in Sjögren’s disease now fully enrolled and study completion expected in the second half of 2026.

我們也正在推進 dazodalibep 的研發，這是一種針對 CD40 配體的生物治療藥物，目前針對乾燥症的 3 期研究已全部入組，預計將於 2026 年下半年完成。

We're pleased today to announce positive Phase 2 data with daxdilimab, a first-in-class plasmacytoid dendritic cell depleting monoclonal antibody targeting ILT7, or the immunoglobulin-like transcript 7 protein. This study in patients with primary discoid lupus erythematosus met both primary and key secondary endpoints with an attractive safety profile.

今天我們很高興地宣布 daxdilimab 的積極 2 期數據，daxdilimab 是一種首創的漿細胞樣樹突狀細胞清除單株抗體，靶向 ILT7（免疫球蛋白樣轉錄物 7 蛋白）。這項針對原發性盤狀紅斑狼瘡患者的研究達到了主要終點和關鍵次要終點，且安全性良好。

Encouraged by these data, we are working to advance daxdilimab to the next phase of development in this setting.

受這些數據的鼓舞，我們正在努力推動 daxdilimab 在此領域的下一階段研發。

In inflammation, the TEZSPIRE Phase 3 program continues to advance with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, where we expect study completion in the second half of this year.

在發炎領域，TEZSPIRE 3 期計畫持續推進，目前正在進行慢性阻塞性肺病和嗜酸性食道炎的研究，我們預計這些研究將於今年下半年完成。

We recently announced the decision to terminate the rocatinlimab development and commercialization collaboration with Kyowa Kirin. With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs. Rocatinlimab will return to our partners at Kyowa Kirin who will assume full ownership of the program.

我們最近宣布了終止與協和麒麟株式會社 (Kyowa Kirin) 的 rocatinlimab 開發和商業化合作的決定。由於我們在所有四個治療領域都擁有相當的廣度和深度，我們決定調整投資組合，將資源集中投入其他後期項目。Rocatinlimab 將歸還給我們的合作夥伴 Kyowa Kirin，他們將全面擁有該專案。

Turning to oncology. In November, the FDA granted full approval to IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. This approval represents a meaningful advancement for patients facing a disease that has seen very little innovation for decades.

轉向腫瘤學。11 月，FDA 正式批准 IMDELLTRA 用於治療接受鉑類化療期間或之後病情進展的廣泛期小細胞肺癌成年患者。對於幾十年來幾乎沒有任何創新療法的疾病患者來說，這項批准代表著一項意義重大的進步。

To extend the impact of IMDELLTRA, we are presently advancing this medicine as combination therapy in front-line extensive-stage small cell where we observed unprecedented survival in early phase clinical trials. Further, we are also advancing IMDELLTRA with an ongoing Phase 3 study of limited-stage small cell lung cancer. It's a joy to see IMDELLTRA, like BLINCYTO, becoming a standard of care in the management of advanced cancer.

為了擴大 IMDELLTRA 的影響，我們目前正在推動該藥物作為一線廣泛期小細胞肺癌聯合療法的研發，我們在早期臨床試驗中觀察到了前所未有的生存率。此外，我們也正在推動 IMDELLTRA 的 3 期臨床試驗，該試驗針對的是局部小細胞肺癌。看到 IMDELLTRA 像 BLINCYTO 一樣成為晚期癌症治療的標準療法，真是令人欣慰。

Our first-in-class STEAP1 directed bispecific T cell engager xaluritamig, continues to advance through Phase 3 development in prostate cancer.

我們首創的 STEAP1 標靶雙特異性 T 細胞銜接器 xaluritamig 在前列腺癌的 3 期臨床試驗中持續推進。

Beyond prostate cancer, we have recently initiated a Phase 1b study in relapsed or refractory Ewing sarcoma, a rare malignancy with high STEAP1 expression and patients in an urgent need for targeted therapy.

除了前列腺癌之外，我們最近還啟動了一項針對複發或難治性尤文氏肉瘤的 1b 期研究，這是一種罕見的惡性腫瘤，STEAP1 表達水平高，患者迫切需要標靶治療。

Across IMDELLTRA, BLINCYTO, and xaluritamig, we continue to see meaningful long-term impact from our bispecific T cell engager platform. We remain committed to bringing transformative and innovative therapies like these to patients with cancer.

在 IMDELLTRA、BLINCYTO 和 xaluritamig 中，我們持續看到我們的雙特異性 T 細胞銜接器平台產生有意義的長期影響。我們將繼續致力於為癌症患者帶來此類變革性和創新性療法。

To close out oncology, given the previously announced results from FORTITUDE-101 and FORTITUDE-102, we have decided not to pursue regulatory approval for bemarituzumab, our FGFR2b targeting monoclonal antibody in first-line gastric cancer. The overall efficacy did not meet our expectations. We observed an emerging signal of putative survival benefit in a subset of biomarker defined patients. We expect to share these findings with the scientific community in the future.

為了結束腫瘤學研究，鑑於先前發表的 FORTITUDE-101 和 FORTITUDE-102 研究結果，我們決定不再尋求 bemarituzumab（一種靶向 FGFR2b 的單株抗體，用於一線治療胃癌）的監管批准。整體療效未達到我們的預期。我們觀察到，在部分生物標記定義的患者中，出現了潛在的生存獲益訊號。我們計劃在未來與科學界分享這些研究成果。

As with rocatinlimab, we took a portfolio decision to focus resources on our other late-stage programs. Across biosimilars, both ABP 206 and ABP 234 biosimilar candidates to OPDIVO and KEYTRUDA, respectively, have completed enrollment in each of their comparative clinical studies supporting continued progress of the next wave of our biosimilar portfolio.

與 rocatinlimab 一樣，我們做出了投資組合決策，將資源集中投入到我們其他後期專案中。在生物相似藥方面，ABP 206 和 ABP 234 分別是 OPDIVO 和 KEYTRUDA 的生物相似藥候選藥物，它們各自的比較臨床研究均已完成入組，這支持了我們下一波生物相似藥產品組合的持續進展。

Before closing, as described in our press release, we are engaged in an ongoing dialogue with the FDA regarding TAVNEOS, our medicine for the treatment of a rare and severe disease, ANCA-associated vasculitis. We will update you on those discussions as necessary.

在結束之前，正如我們在新聞稿中所述，我們正在與 FDA 就 TAVNEOS（一種用於治療罕見且嚴重的疾病——ANCA 相關性血管炎的藥物）進行持續對話。我們會視需要向您通報相關討論進度。

Now let me finish by saying that 2025 was a year of consistent execution, real scientific progress, and disciplined decision-making. We expect 2026 to bring another year of strong execution, disciplined data generation, and new scientific advances as we continue to progress our robust pipeline.

最後我想說，2025 年是持續執行、真正科學進步、嚴謹決策的一年。我們預計 2026 年將迎來另一個強勁執行、嚴謹數據產生和新的科學進步的年份，我們將繼續推進我們強大的研發管線。

I want to thank our colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases. With a broad and deep pipeline, we are well positioned to deliver sustained long-term growth.

我要感謝安進公司的同事們，感謝他們一直以來對病人的關注，以及他們致力於推動治療嚴重疾病的創新藥物研發。憑藉著廣泛而深厚的產品線，我們完全有能力實現持續的長期成長。

I'll now turn it over to Murdo for the commercial update.

現在我將把商業更新交給默多。

Thanks very much, Jay. In 2025, we delivered 10% sales growth with 13 products achieving double-digit or better performance. 14 products exceeded $1 billion in annual sales and 18 products achieved record sales. These results underscore the strength and growth potential of our portfolio and demonstrate the disciplined execution of our teams serving patients globally.

非常感謝，傑伊。2025年，我們實現了10%的銷售成長，其中13款產品業績達到兩位數或更高。 14款產品年銷售額超過10億美元，18款產品創下銷售紀錄。這些結果凸顯了我們產品組合的實力和成長潛力，並展現了我們服務全球患者的團隊的嚴謹執行力。

Starting with General Medicine, Repatha sales grew 36% year over year in 2025, surpassing $3 billion. This performance was driven by growing urgency to treat patients in both secondary and primary prevention. Today, more than 100 million people around the world still need effective LDL-cholesterol lowering. And Repatha remains the first and only PCSK9 inhibitor with outcomes data for patients in both high-risk primary and secondary prevention.

從普通藥物開始，Repatha 的銷售額在 2025 年年增 36%，超過 30 億美元。這一業績的取得，是由於在二級預防和一級預防方面，治療患者的緊迫性日益增強所致。如今，全球仍有超過1億人需要有效降低低密度脂蛋白膽固醇。而 Repatha 仍然是第一個也是唯一一個擁有針對高風險病人一級預防和二級預防療效數據的 PCSK9 抑制劑。

As Jay mentioned, the landmark VESALIUS-CV trial showed a reduction in the risk of first major cardiovascular events by 25% in high-risk patients. These data strengthen Repatha's position as the most evidence-backed therapy in the PCSK9 class and support this critical role in earlier and more intensive LDL cholesterol management.

正如 Jay 所提到的，具有里程碑意義的 VESALIUS-CV 試驗表明，高風險患者首次發生重大心血管事件的風險降低了 25%。這些數據鞏固了 Repatha 作為 PCSK9 類藥物中證據最充分的療法的地位，並支持其在早期和更積極的 LDL 膽固醇管理中發揮的關鍵作用。

Given these results and our leadership in this category, we believe there's now a clear opportunity to update clinical guidelines and quality measures. We expect these changes will encourage cardiologists and primary care physicians to manage LDL cholesterol more proactively alongside lifestyle modification and reduced cardiovascular risk in both primary and secondary prevention.

鑑於這些成果以及我們在該領域的領先地位，我們認為現在顯然有機會更新臨床指南和品質指標。我們預計這些變化將鼓勵心臟病專家和初級保健醫生在初級和二級預防中，透過改變生活方式和降低心血管風險，更積極地管理低密度脂蛋白膽固醇。

In the US, we continue to improve patient access to Repatha with broad formulary coverage and the launch of AmgenNow, our new direct-to-patient program. AmgenNow offers a simplified lower cost cash pay option for patients to access Repatha. Following a successful launch, we've announced plans to expand this program to additional medicines and we're excited to make our therapies available through TrumpRx, helping improve affordability for Americans.

在美國，我們透過擴大藥品目錄覆蓋範圍和推出新的直接面向患者的計劃 AmgenNow，繼續改善患者獲得 Repatha 的機會。AmgenNow 為患者提供了一種更簡單、成本更低的現金支付方式來獲取 Repatha。在成功推出之後，我們宣布計劃將該計劃擴展到更多藥物，我們很高興能夠透過 TrumpRx 提供我們的療法，幫助提高美國人的用藥負擔能力。

EVENITY sales increased 34% in 2025, reaching $2.1 billion in sales. EVENITY remains the only treatment that simultaneously builds new bone and reduces bone resorption, a dual mechanism that has proven to rapidly reduce fracture risk in postmenopausal women.

2025年，EVENITY的銷售額成長了34%，達到21億美元。EVENITY 仍然是唯一一種能夠同時促進新骨生成和減少骨吸收的治療方法，這種雙重機制已被證明可以迅速降低停經後婦女的骨折風險。

In the US, EVENITY sales grew 41%, driven by higher volumes from both established and new prescribers. EVENITY leads the bone builder segment with over 60% market share and is now growing faster than the category overall. To date, approximately 300,000 US patients have been treated with EVENITY with a 33% increase of new patients in just one year.

在美國，EVENITY 的銷售額成長了 41%，這主要得益於現有醫生和新醫生處方量的增加。EVENITY 在骨骼強化劑領域佔據領先地位，市場份額超過 60%，目前成長速度超過了整個品類的成長速度。迄今為止，美國已有約 30 萬名患者接受了 EVENITY 治療，僅一年內新患者數量就增加了 33%。

Increased investment has helped accelerate this growth, which we expect to continue.

投資的增加加速了這一成長，我們預計這一成長動能將持續下去。

Despite strong progress, nearly 90% of the 2 million women at very high risk of fracture remain untreated, presenting a clear opportunity for EVENITY to drive growth and impact. Prolia delivered $4.4 billion in sales in 2025, an increase of 1% year over year. In 2026, we expect accelerated sales erosion driven by increased competition as multiple biosimilars have launched globally.

儘管取得了顯著進展，但 200 萬骨折高風險女性中仍有近 90% 未接受治療，這為 EVENITY 推動成長和產生影響提供了明顯的機會。Prolia 預計 2025 年銷售額將達到 44 億美元，年增 1%。預計到 2026 年，隨著多種生物相似藥在全球上市，競爭加劇，銷售額將加速下滑。

Our rare disease portfolio grew 14% year over year to nearly $5.2 billion and 19% in the quarter with strong performance across the portfolio. UPLIZNA sales increased 73% year over year to $655 million, reflecting growing patient demand across all three approved indications. In December, UPLIZNA received FDA approval for the treatment of generalized myasthenia gravis, marking an important milestone for patients with this chronic debilitating disease.

我們的罕見疾病業務組合年增 14%，達到近 52 億美元，季度成長 19%，整個業務組合表現強勁。UPLIZNA 的銷售額年增 73%，達到 6.55 億美元，反映出所有三個核准適應症的患者需求不斷增長。12 月，UPLIZNA 獲得 FDA 批准用於治療全身型重症肌無力，這對於患有這種慢性衰弱性疾病的患者來說是一個重要的里程碑。

Hourly physician response has been strong across both bio-naive and switch patients. Prescribers have noted the benefits of UPLIZNA's upstream B-cell mechanism, targeting the root cause of the disease and it also has demonstrated safety profile and the convenience of its twice-yearly dosing. Uptake of UPLIZNA for use in IgG4-related disease continues to grow. Since the launch in the US, nearly 500 specialists, including rheumatologists, gastroenterologists, among others, have prescribed UPLIZNA.

醫生每小時的回饋都很強，無論是初次接受生物製劑治療的患者或是需要轉換治療的患者。處方醫生注意到 UPLIZNA 的上游 B 細胞機制的益處，它針對疾病的根本原因，並且還證明了其安全性以及每年兩次給藥的便利性。UPLIZNA 在 IgG4 相關疾病的應用持續成長。自在美國上市以來，包括風濕病學家、胃腸病學家等在內的近 500 位專家都開立了 UPLIZNA 處方。

In addition to the more recent launches, UPLIZNA continues to lead in NMOSD and remains the most prescribed FDA-approved therapy in the US for this condition, supported by consistent new patient growth and strong adherence across treatment cycles.

除了最近推出的產品外，UPLIZNA 在 NMOSD 領域繼續保持領先地位，並且仍然是美國 FDA 批准用於治療該疾病的處方量最多的療法，這得益於持續的新患者增長和治療週期中患者的良好依從性。

TEPEZZA grew 3% to $1.9 billion in 2025 driven by higher net selling price. Over 25,000 patients have received treatment since launch in the US with growing interest from both new and returning prescribers. We continue to see increased prescribing by endocrinologists and a broadening base of specialists.

TEPEZZA 預計 2025 年營收將成長 3%，達到 19 億美元，主要得益於淨售價上漲。自從該療法在美國推出以來，已有超過 25,000 名患者接受了治療，新舊處方醫生都對其表現出越來越濃厚的興趣。我們看到內分泌科醫師的處方量持續增加，專科醫師的範圍也不斷擴大。

In Japan, approximately 1,200 patients have been treated since launch, reflecting growing awareness of the burden of thyroid eye disease among both patients and prescribers. We plan to launch TEPEZZA in additional markets in 2026, expanding access to this important therapy globally.

在日本，自推出以來，已有約 1200 名患者接受了治療，這反映出患者和處方醫生對甲狀腺眼疾負擔的認識不斷提高。我們計劃於 2026 年在更多市場推出 TEPEZZA，從而在全球範圍內擴大這種重要療法的可及性。

TAVNEOS sales were $459 million in 2025, an increase of 62% year over year driven by strong volume growth. More than 7,000 patients with ANCA-associated vasculitis have now been treated with TAVNEOS with over 4,000 healthcare professionals prescribing the therapy since its launch in 2021.

2025 年 TAVNEOS 的銷售額為 4.59 億美元，年增 62%，這主要得益於強勁的銷售成長。自 2021 年推出以來，已有超過 7,000 名 ANCA 相關血管炎患者接受了 TAVNEOS 治療，超過 4,000 名醫療保健專業人員開立了該療法。

ANCA-associated vasculitis is a serious, potentially life-threatening disease that can cause significant organ damage if not well controlled and has limited therapeutic options. We remain confident that TAVNEOS is an important and effective medicine based on clinical data, real-world evidence, and its favorable benefit risk profile.

ANCA 相關性血管炎是一種嚴重的、可能危及生命的疾病，如果控制不當，可能會造成嚴重的器官損傷，而且治療選擇有限。基於臨床數據、真實世界證據及其良好的獲益風險比，我們仍然相信 TAVNEOS 是一種重要且有效的藥物。

In inflammation, TEZSPIRE sales grew 52% year over year to nearly $1.5 billion for the full year. TEZSPIRE is well positioned to reach more patients in the United States due to its differentiated TSLP mechanism that targets multiple inflammatory pathways driving severe uncontrolled asthma, including in those with coexisting chronic rhinosinusitis with nasal polyps.

在發炎治療領域，TEZSPIRE 的銷售額年增 52%，全年銷售額接近 15 億美元。由於其差異化的 TSLP 機制，TEZSPIRE 能夠靶向驅動嚴重未控制氣喘的多種發炎通路，包括那些同時患有慢性鼻竇炎和鼻息肉的患者，因此 TEZSPIRE 在美國具有良好的市場地位，能夠惠及更多患者。

TEZSPIRE substantially reduced the need for surgery in this population, reinforcing its value in eosinophilic disease. TEZSPIRE is now the leading therapy for new-to-brand patients amongst allergists in severe uncontrolled asthma, fueled by strong prescriber confidence and continued expansion across respiratory specialties.

TEZSPIRE 大大減少了該族群的手術需求，鞏固了其在嗜酸性粒細胞疾病中的價值。TEZSPIRE 目前已成為過敏科醫生治療重度未控制氣喘新患者的首選療法，這得益於處方醫生的強烈信心以及呼吸系統專科領域的持續擴張。

Otezla sales increased 7% year over year to nearly $2.3 billion. For 2026, we expect sales erosion driven by unfavorable pricing in the US and generic launches, particularly in the EU.

Otezla 的銷售額年增 7%，達到近 23 億美元。預計到 2026 年，由於美國定價不利以及仿製藥上市（尤其是在歐盟），銷售額將下滑。

Our innovative oncology portfolio, which includes BLINCYTO, IMDELLTRA, LUMAKRAS, Vectibix, KYPROLIS, Nplate, and XGEVA grew 11% year over year, generating $8.7 billion in full year sales.

我們創新的腫瘤產品組合，包括 BLINCYTO、IMDELLTRA、LUMAKRAS、Vectibix、KYPROLIS、Nplate 和 XGEVA，較去年同期成長 11%，全年銷售額達 87 億美元。

IMDELLTRA delivered $627 million of full year sales, fueled by strong clinical conviction and rapid adoption across care settings. Over 1,600 US sites now administer IMDELLTRA with the majority of doses provided in the community setting. IMDELLTRA was granted full FDA approval in the fourth quarter, supported by compelling data from the Phase 3 DeLLphi-304 trial.

IMDELLTRA 全年銷售額達 6.27 億美元，這得益於其強大的臨床療效和在各種護理機構中的快速應用。目前美國有超過 1600 個地點提供 IMDELLTRA 疫苗，其中大部分的劑量是在社區環境中提供。IMDELLTRA 在第四季度獲得了 FDA 的全面批准，這得益於 3 期 DeLLphi-304 試驗的令人信服的數據。

NCCN guidelines also recognized IMDELLTRA as the highest recommended therapy and it has become the standard of care in the second-line setting, reinforcing its leadership position in small cell lung cancer.

NCCN 指南也認可 IMDELLTRA 為最高推薦療法，它已成為二線治療的標準療法，鞏固了其在小細胞肺癌領域的領先地位。

BLINCYTO grew 28% year over year to over $1.5 billion in full year sales, driven by broad prescribing across both academic and community segments. BLINCYTO is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome-negative B-cell ALL.

BLINCYTO 的全年銷售額年增 28%，超過 15 億美元，這主要得益於學術界和社區的廣泛處方。BLINCYTO 與多藥化療聯合用於治療費城染色體陰性 B 細胞 ALL 患者，被廣泛認為是標準治療方案。

Our biosimilar portfolio delivered another strong year with sales increasing 37% to $3 billion. Our expanding biosimilar portfolio provides meaningful top-line growth, durable cash flow, and broad patient access to high-quality cost savings for biologic medicines.

我們的生物相似藥產品組合又迎來了一個強勁的年份，銷售額成長了 37%，達到 30 億美元。我們不斷擴大的生物相似藥產品組合可帶來顯著的收入成長、持久的現金流，並使廣大患者能夠以較低的成本獲得高品質的生物製劑。

PAVBLU, a biosimilar to EYLEA continues to gain momentum, reaching $700 million in sales in 2025. Adoption continues to build among retina specialists who value the product’s ready-to-use, pre-filled syringe format and the reliability of Amgen's manufacturing and supply chain.

PAVBLU 是 EYLEA 的生物相似藥，其發展勢頭持續強勁，預計到 2025 年銷售額將達到 7 億美元。該產品採用即用型預填充注射器形式，且安進公司生產和供應鏈可靠，因此在視網膜專家中越來越受歡迎。

We delivered strong results in 2025 with continued momentum across our priority growth brands, and we look forward to serving even more patients with Amgen products in 2026.

2025 年，我們取得了強勁的業績，重點成長品牌持續保持成長勢頭，我們期待在 2026 年用安進產品為更多患者提供服務。

Now I'd like to hand it over to Peter.

現在我想把它交給彼得。

Thank you, Murdo. We're pleased with our execution and performance in the fourth quarter and for the full year 2025, and we remain on track with our long-term objectives. The financial results are shown on slides 34 to 36 of the slide deck.

謝謝你，默多。我們對第四季度和 2025 年全年的執行情況和業績感到滿意，我們將繼續朝著長期目標穩步前進。財務結果顯示在投影片的第 34 至 36 頁。

Murdo has covered our strong revenue growth across the portfolio. For the full year, we delivered a non-GAAP operating margin of 46%. We continue to invest in advancing our pipeline with non-GAAP R&D spending increased 22% year over year for the full year to a record $7.2 billion. This reflects increased spending on an unprecedented number of opportunities in our late-stage pipeline, including continued investments in MariTide, olpasiran, xaluritamig, and rare disease.

Murdo 為我們整個投資組合的強勁收入成長提供了保障。全年非GAAP營業利益率為46%。我們持續投資推進產品線，全年非GAAP研發支出年增22%，達到創紀錄的72億美元。這反映出我們在後期研發管線中前所未有的眾多機會上增加了支出，包括對 MariTide、olpasiran、xaluritamig 和罕見疾病的持續投資。

In addition, we closed several business development transactions in the third and fourth quarters, resulting in roughly $300 million in incremental R&D spending.

此外，我們在第三季和第四季完成了幾項業務發展交易，帶來了約 3 億美元的額外研發支出。

Full year non-GAAP other income and expense was $2.1 billion. We continued to strengthen our balance sheet with $6 billion of debt retired in 2025. Our non-GAAP tax rate increased 1.4 percentage points year over year to 15.9% for the full year, primarily due to changes in earnings mix. We generated $8.1 billion in free cash flow for the full year, reflecting operational momentum across the business and rigorous management of working capital, all while continuing to invest in innovation.

全年非GAAP其他收入和支出為21億美元。我們繼續加強資產負債表，2025 年償還了 60 億美元的債務。由於獲利結構的變化，我們全年的非GAAP稅率較去年同期上升1.4個百分點至15.9%。我們全年創造了 81 億美元的自由現金流，這反映了公司營運的良好動能和對營運資本的嚴格管理，同時我們也持續投資於創新。

We're leveraging AI across the value chain to accelerate therapeutic discovery and late-stage development, optimize manufacturing, and improve customer engagement allowing us to drive productivity at speed and scale.

我們正在利用人工智慧技術貫穿整個價值鏈，以加速治療藥物的發現和後期開發，優化生產製造，並改善客戶互動，使我們能夠快速、大規模地提高生產力。

We executed capital expenditures of $2.2 billion in 2025. Our capital expenditures reflect significant investments across the United States including Ohio, North Carolina, Puerto Rico, Rhode Island, and California to support continued volume growth in our commercial brands and to prepare for pipeline product launches, including MariTide.

我們在 2025 年執行了 22 億美元的資本支出。我們的資本支出反映了我們在美國各地（包括俄亥俄州、北卡羅來納州、波多黎各、羅德島和加利福尼亞州）的大量投資，以支持我們商業品牌的持續銷售成長，並為管道產品（包括 MariTide）的推出做好準備。

In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024.

此外，我們在第四季度透過每股 2.38 美元的有競爭力的股息支付向股東返還了資本，與 2024 年相比增長了 6%。

Let's turn to the 2026 outlook on slide 37. We expect our 2026 total revenues in the range of $37.0 billion to $38.4 billion, and non-GAAP earnings per share between $21.60 to $23. Our revenue range reflects continuing strong performance from our six key growth drivers: Repatha, EVENITY, TEZSPIRE, our rare disease, innovative oncology, and biosimilars portfolios, positioning 2026 as a springboard year for future growth.

讓我們來看看第 37 頁關於 2026 年的展望。我們預計 2026 年總收入將在 370 億美元至 384 億美元之間，非 GAAP 每股收益將在 21.60 美元至 23 美元之間。我們的收入範圍反映了我們六大關鍵成長驅動因素的持續強勁表現：Repatha、EVENITY、TEZSPIRE、我們的罕見疾病、創新腫瘤和生物相似藥產品組合，使 2026 年成為未來成長的跳板之年。

We expect this growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition, price declines for certain other products in 2026, and continued increases in 340B program utilization. As you model the first quarter of 2026, consistent with historical trends tied to the annual United States health insurance cycle, we expect a seasonal headwind to sales, driven by benefit plan changes, insurance reverifications, and higher patient co-pay obligations.

我們預計 2026 年的成長將超過因地諾單抗生物相似藥競爭加劇、2026 年某些其他產品價格下降以及 340B 計畫使用量持續增加而導致的預期下降。在對 2026 年第一季進行建模時，根據與美國年度健康保險週期相關的歷史趨勢，我們預計銷售額將面臨季節性不利因素，這是由於福利計劃變更、保險重新核實以及患者自付費用增加所致。

We also expect Otezla and Enbrel to follow their historical pattern of lower sales in the first quarter relative to subsequent quarters and expect additional impact from denosumab biosimilar competition in Q1.

我們也預期 Otezla 和 Enbrel 將延續其歷史規律，即第一季的銷售額將低於後續季度，並預計第一季地諾單抗生物相似藥的競爭將帶來額外影響。

Additionally, note that we saw roughly $250 million of inventory build in the fourth quarter of 2025 that could potentially impact first quarter sales. For total company revenues, we expect lower mid-single-digit year-over-year growth in the first quarter. For the full year, we expect other revenue in the range of $1.6 billion to $1.8 billion reflecting our commitment to investing in the best innovation while also driving execution excellence, efficiency and prioritization across the organization, we project the full year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%.

此外，請注意，我們看到 2025 年第四季庫存增加了約 2.5 億美元，這可能會影響第一季的銷售額。我們預計公司第一季總收入將實現較低的中個位數年增。全年其他收入預計在 16 億美元至 18 億美元之間，這體現了我們致力於投資最佳創新，同時推動整個組織的卓越執行、效率和優先事項的承諾。我們預計全年非 GAAP 營業利潤率（佔產品銷售額的百分比）約為 45% 至 46%。

This guidance does not include any potential business development transactions that may occur throughout the year.

本指南不包含任何全年可能發生的潛在業務發展交易。

We expect non-GAAP R&D expense to grow low single digits excluding the roughly $300 million of business development transactions in 2025. We continue to execute six global Phase 3 clinical trials for MariTide, advance additional late-stage assets, and invest in the best innovation while maintaining disciplined resource allocation.

我們預計，2025 年非 GAAP 研發費用將以較低的個位數成長，不包括約 3 億美元的業務發展交易。我們繼續執行 MariTide 的六項全球 3 期臨床試驗，推進其他後期資產，並投資於最佳創新，同時保持嚴格的資源分配。

In line with lower product sales in the first quarter, we expect Q1 non-GAAP operating margin to be the lowest of the year and roughly the same as Q4 of 2025. We anticipate non-GAAP other income and expense to be about $2.3 billion to $2.4 billion in 2026. We expect a non-GAAP tax rate of 16% to 17.5%. We expect share repurchases not to exceed $3 billion in 2026.

由於第一季產品銷售下降，我們預計第一季非GAAP營業利潤率將是今年最低的，與2025年第四季大致相同。我們預計 2026 年非 GAAP 其他收入和支出約為 23 億美元至 24 億美元。我們預計非GAAP稅率為16%至17.5%。我們預計2026年股票回購金額不會超過30億美元。

We expect capital expenditures of about $2.6 billion in 2026. This is consistent with our capital allocation priority to invest in our business and scale manufacturing capacity for volume growth, including preparing for MariTide launch.

我們預計 2026 年的資本支出約為 26 億美元。這與我們優先投資於業務和擴大生產能力以實現銷售成長的資本配置策略一致，包括為 MariTide 的上市做準備。

We remain focused on delivering sustained long-term growth and creating value for patients and shareholders by doing what we said we would do, advancing innovation in areas of high unmet medical need, and maintaining rigorous financial discipline. I'm grateful to work with all of our colleagues worldwide in serving patients.

我們將繼續專注於實現持續的長期成長，並透過履行我們承諾的義務、推進醫療需求未得到滿足領域的創新以及保持嚴格的財務紀律，為患者和股東創造價值。我很榮幸能與世界各地的同事們一起為病患服務。

This concludes the financial update. And now I'll hand it back to Bob for Q&A.

財務更新到此結束。現在我把問題交還給鮑勃，讓他回答大家的問題。

Okay. Thank you, Peter. And as I hope you all appreciate it now, I think we ended '25 with our track record intact for having delivered against the objectives that we set for you at the beginning of the year. We're determined to do the same now in 2026. So we're entering the year with momentum, excited about what we see ahead.

好的。謝謝你，彼得。我希望大家現在都能理解，我們在 2025 年結束時，依然保持著良好的記錄，實現了年初為大家設定的目標。我們決心在 2026 年也能做到這一點。因此，我們帶著強勁的勢頭進入新的一年，對未來充滿期待。

Let's open up the call to questions, Julianne. We'd be happy to entertain any of our callers now.

朱莉安娜，現在開始接受提問。我們現在很樂意接聽任何來電。

(Operator Instructions) Michael Yee, UBS Financial.

（操作員指示）Michael Yee，瑞銀金融。

It looks like guidance is growth for the year despite the biosimilars. Obviously, obesity is top of mind for everybody, and you've disclosed some information on MariTide recently. I was wondering and curious to ask your view of the portfolio overall in obesity given that for like today are disclosing combinations with monthly or monthly and then combinations and how you see this playing out given you're focused on MariTide, but [not sure] about the rest of the portfolio there. Thank you.

儘管面臨生物相似藥的挑戰，但今年的業績預期仍將保持成長。顯然，肥胖是每個人都非常關心的問題，你最近也透露了一些關於 MariTide 的資訊。我很好奇，想問問您對肥胖症投資組合的整體看法，因為像今天這樣披露的是按月或按月組合的股票，以及您認為這會如何發展，因為您專注於 MariTide，但不確定投資組合中的其他股票會如何發展。謝謝。

Okay. Thank you, Michael. We'll take a stab at answering your questions. Connection wasn't great, but I think we got most of what you were trying to ask.

好的。謝謝你，麥可。我們會盡力回答您的問題。連接不太好，但我認為我們基本上了解了你想問的問題。

Jay, do you want to kick off?

傑伊，你想開火嗎？

Yes, I'd be happy to. Thanks, Michael. Amgen's really made for this moment, developing MariTide across so many different indications, a leading cardiovascular company, also a leading respiratory disease company, and there are so many opportunities there for MariTide.

是的，我很樂意。謝謝你，麥可。安進公司正是為了這個時刻而生的，它針對多種不同的適應症開發了 MariTide，作為一家領先的心血管公司和呼吸系統疾病公司，MariTide 擁有如此多的機會。

We've been in obesity, as you know, a long while all the way back to the leptin days and enjoyed stable discovery leadership team since that time. Internally, we have another clinical stage asset, called AMG 513. We have yet to disclose the mechanism of that medicine is progressing in Phase 1 clinical investigation.

如您所知，我們從事肥胖症研究已經很久了，可以追溯到瘦素時代，並且從那時起就擁有穩定的研發領導團隊。內部我們還有另一項處於臨床階段的資產，名為 AMG 513。我們尚未公佈該藥物的作用機制，目前該藥物正處於第 1 期臨床試驗階段。

And preclinically, we have a rather exciting set of rising programs that are both increasing base as well as nonincreasing base, both injectable as well as oral medicines. And the aperture is always open for innovation on the outside.

在臨床前研究方面，我們有一系列相當令人興奮的新興項目，這些項目既包括擴大基礎的藥物，也包括不擴大基礎的藥物，既包括注射劑，也包括口服藥物。而且，外部創新的大門始終敞開。

I think you should expect us to be competing broadly in the field, Michael.

邁克爾，我認為你應該預料到我們會在該領域展開廣泛的競爭。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

I have a question actually about dazodalibep for primary Sjögren’s Syndrome. It looks like both studies are now fully enrolled, and you're saying completion in the second half, the only company with both the systemic and the symptomatic study in Phase 3 based on the Phase 2s. Should we expect the data this year? And do you want to give us any color on the reliability of the Phase 2 into the Phase 3, just given it's a tough condition?

我其實有一個關於達唑達利貝治療原發性乾燥症的問題。看起來這兩項研究都已全部招募完畢，您說將在下半年完成，這是唯一一家基於 2 期研究結果，同時開展系統性和症狀性 3 期研究的公司。我們今年能獲得這些數據嗎？鑑於第二階段過渡到第三階段的條件十分苛刻，您能否就此透露一些關於其可靠性的資訊？

Thanks, Yaron, and thanks for noticing about dazodalibep. This is a very exciting medicine in the portfolio. This is a CD40 ligand targeting biotherapeutic and the CD40 pathway has long been postulated to be driving the inflammatory cascade in Sjogren's Syndrome. The challenge is only that the biology is somewhat ambiguous. And so we take a really nice and incisive approach with dazodalibep disease.

謝謝 Yaron，也謝謝你注意到 dazodalibep。這是產品組合中非常令人振奮的藥物。這是一種針對 CD40 配體的生物治療藥物，長期以來人們一直認為 CD40 路徑是乾燥症中發炎級聯反應的驅動因素。唯一的挑戰在於，生物學原理在某種程度上是模糊的。因此，我們對達唑達利貝氏症採取了非常出色且深刻的方法。

As you noted, the two Phase 3s that we have opened in Sjögren’s syndrome will be in moderate to severe symptomatic activity. That's our population one as well as in patients with a very high symptom burden. That's population two. Sjögren’s has been very challenging for drug development, but here we find this hypothesis is quite compelling.

正如您所指出的，我們已在乾燥症領域進行的兩項 3 期臨床試驗將針對中度至重度症狀活動期的患者。這適用於我們的人群，也適用於症狀負擔非常重的患者。那是人口二。乾燥症對藥物研發來說一直是一個很大的挑戰，但我們發現這個假設很有說服力。

The second study has already completed enrollment of patients. This is the MariTide in the burden group with low systemic disease activity. And we expect completion of the trials later this year, and we'll inform later about our plans to communicate this information.

第二項研究已經完成了病患招募。這是系統性疾病活動度較低的疾病負擔組中的 MariTide。我們預計試驗將於今年稍後完成，稍後我們將公佈有關如何傳達這些訊息的計劃。

As for reading through the reliability of Phase 2 into Phase 3, there have been historic challenges here. but the performance against this SDI score, which is the clinically utilized as well as regulatory paradigm for approval was one of the first medicine ever to improve an STI score in that disease space. So we're confident going into Phase 3, I can't wait to look at the results.

至於如何將二期臨床試驗的可靠性推論到第三期臨床試驗中，這方面一直存在挑戰。但就臨床應用和監管審批所依據的SDI評分而言，該藥物的表現是第一批在該疾病領域改善STI評分的藥物之一。所以我們很有信心進入第三階段，我迫不及待想看看結果。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

So I had a couple of UPLIZNA-related questions. Can you talk about the extent to which the underlying IgG4-related disease population is larger than what literature has suggested historically and what that means for the underlying opportunity?

我有一些與UPLIZNA相關的問題。您能否談談實際的 IgG4 相關疾病患者群體比以往文獻所記載的要大多少，以及這對潛在的治療機會意味著什麼？

And then secondly, I know it's early in gMG, but just -- can you talk about how the product is being used to date? And what kind of role do you think it's going to have in an admittedly more crowded treatment armamentarium?

其次，我知道現在還處於 gMG 的早期階段，但是——您能談談該產品迄今為止的使用情況嗎？那麼，你認為它在日益擁擠的治療手段中會扮演什麼樣的角色呢？

Yes. Let's -- don't we tackle this in two parts. Jay, if you take the first part and then maybe, Murdo, you can jump in on the second.

是的。我們不妨分成兩個部分來解決這個問題。傑伊，如果你先完成第一部分，那麼默多，也許你可以加入第二部分。

There is, in medicine, an experience where the availability of a targeted therapy, a really effective therapy, can actually increase the incidence of a disease through awareness of the disease, why take a diagnosis unless you have reason to intervene effectively. And that may, in the fullness of time, be the case here, limiting a precise description of the epidemiology, even over the last 5 to 10 years is the lack of really coherent registry data as well as appropriate coding that would allow such an analysis from electronic medical record data.

在醫學領域，有一種經驗表明，標靶療法（一種非常有效的療法）的出現，實際上可能會因為人們對疾病的認識而增加疾病的發生率。除非有理由有效幹預，否則為什麼要進行診斷？隨著時間的推移，情況可能確實如此，即使在過去的 5 到 10 年裡，由於缺乏真正連貫的登記資料以及適當的編碼，無法從電子病歷資料中進行此類分析，因此難以對流行病學進行精確描述。

And so I think it's a good question. I think it's a moving object, and we'll have better precision on that in the few years to come. But Murdo, what are your instincts?

所以我認為這是一個很好的問題。我認為它是一個移動的物體，未來幾年我們會對此有更精確的了解。但是默多，你的直覺是什麼？

I think that's a very clear description, Jay. I think the availability of the ICD-10 coding as you alluded to, is really about a three-year presence in the market. Right now, we estimate the diagnosed population to be in the neighborhood of 35,000 and that could grow. As you outlined, there are mentions in the literature of higher numbers.

傑伊，我覺得這個描述非常清楚。我認為正如您所提到的，ICD-10 編碼的普及實際上需要三年時間才能在市場上應用。目前，我們估計確診人數約為 35,000 人，而且這個數字可能還會增加。正如你所概述的，文獻中確實提到更大的數字。

However, we're obviously focused on those that are already diagnosed already in care, and we're trying to build that awareness that you spoke of. Again, so far so good. UPLIZNA is doing extremely well in its uptake in IgG4-related diseases. We see a nice breadth of prescribing across a number of different specialties that see these patients because of the end organ involvement in the inflammatory condition.

但是，我們顯然更關注那些已經確診並正在接受治療的患者，我們正在努力提高人們的意識，正如你所說。目前為止一切順利。UPLIZNA 在 IgG4 相關疾病的治療中取得了非常好的效果。由於發炎性疾病會導致終末器官受累，我們看到許多不同專科的醫生都會對這些患者開立處方，而且處方範圍很廣。

And we'll continue to make sure that we do our part to improve that awareness, improve that diagnosis. These patients undergo a very complicated patient journey in that this disease can masquerade as many other things. But so far so good, and we're happy to be able to help these patients finally get a treatment, the only one FDA approved that can help with their symptoms and obviously, the long-term health outcomes particularly for their target organs.

我們將繼續盡我們所能，提高公眾意識，改善診斷。這些患者的治療過程非常複雜，因為這種疾病可以偽裝成許多其他疾病。但到目前為止一切順利，我們很高興能夠幫助這些患者最終獲得治療，這是唯一一種獲得 FDA 批准的、可以幫助緩解他們症狀的治療，而且顯然，還能改善他們的長期健康狀況，特別是對他們的目標器官。

Just on UPLIZNA and gMG, we're very pleased with the initial uptake. As you said, David, it's very early in the launch. But what we're pleased about, and I mentioned this in my opening remarks, is that roughly half of the patients who are being treated are bio-naive patients and the other half coming from switches from other therapies.

僅就 UPLIZNA 和 gMG 而言，我們對初步的市場反應非常滿意。正如你所說，大衛，現在還處於發布初期。但令我們感到欣慰的是，我在開場白中也提到過，接受治療的患者中大約有一半是生物製劑初治患者，另一半則是從其他療法轉而來。

As we've said before, this is a large but still quite dissatisfied category where the current treatments have limitations whether that be dosing inconvenience, whether that be duration of efficacy and perhaps some waning efficacy in this category. And so far, what we've seen is a very strong interest in UPLIZNA for its mechanism as well as for the convenience that it represents for patients.

正如我們之前所說，這是一個龐大但仍相當不滿意的類別，目前的治療方法有其局限性，無論是劑量不便、療效持續時間，還是療效逐漸減弱等問題。到目前為止，我們看到人們對 UPLIZNA 的作用機制以及它為患者帶來的便利性表現出了非常濃厚的興趣。

So so far, so good, excited about UPLIZNA overall in the broader rare disease portfolio.

目前為止一切順利，我對UPLIZNA在更廣泛的罕見疾病產品組合中的整體表現感到興奮。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Just a follow-up here on UPLIZNA. Walk us through what's giving you confidence here and moving forward with a Phase 3 study in CIDP and the opportunity in that indication. And if you could also just separately touch on Repatha and how you're thinking about potential impact from the launch of Merck's oral PCSK9 and how you're adapting your commercial strategy there?

這裡是 UPLIZNA 的後續報導。請您詳細介紹一下是什麼讓您對推進 CIDP 的 3 期研究充滿信心，以及該適應症帶來的機會。另外，您能否單獨談談瑞百安（Repatha），以及您如何看待默克公司口服PCSK9抑制劑上市可能帶來的影響，以及您如何調整這方面的商業策略？

We have two ends of the spectrum there from the very rare to the very common. So let's do -- Jay, you do the first question, and then Murdo, you can take the second.

這裡有兩個極端，從非常罕見到非常常見。那我們來吧——傑伊，你先回答第一個問題，然後默多，你可以回答第二個問題。

Thanks, Salveen. We are, as Murdo shared, very bullish about UPLIZNA. Specifically this unique mechanism of action that targets and depletes the CD19 pathologic B-cell, these, as you surely know, CD19, the B cell compartment is evident on mature B cells like CD20 targeted by rituximab and other medicines of that type, but also the pre B cell, the more naive B cell, the cell that expands and elaborates many of these auto antibodies.

謝謝你，薩爾文。正如 Murdo 所說，我們非常看好 UPLIZNA。具體來說，這種獨特的作用機制可針對並清除 CD19 病理 B 細胞。正如您肯定知道的那樣，CD19 是 B 細胞區室，在成熟的 B 細胞（如 CD20）上很明顯，利妥昔單抗和其他此類藥物就是以 CD20 為靶點，但它也存在於前 B 細胞、更幼稚的 B 細胞上，這種細胞會擴增並產生許多自身抗體。

And so now seeing efficacy of UPLIZNA in so many immunoglobulin related disorders, like IgG4-related disease, like myasthenia gravis, the chance to bring it to additional autoantibody-mediated immune conditions, it's just a great chance to help patients with these severe diseases.

現在，我們看到 UPLIZNA 在許多免疫球蛋白相關疾病（如 IgG4 相關疾病，如重症肌無力）中都顯示出療效，有機會將其應用於其他自身抗體介導的免疫疾病，這對於幫助患有這些嚴重疾病的患者來說是一個絕佳的機會。

In some cases, there are signals from CD20 that we intend to follow up with a broader, more active and hopefully much more convenient UPLIZNA.

在某些情況下，CD20 發出了一些信號，我們打算透過更廣泛、更積極、希望也更方便的 UPLIZNA 來跟進。

Autoimmune hepatitis, which I mentioned earlier, is associated with autoantibodies you see ANA, you see anti smooth muscle, you see anti actin, you see anti LC1. And the same is true, though, to a lower proportion with CIDP as well, where maybe 5% to 10% of patients will have autoantibodies to what are called a pair of nodal proteins of 155 and CMTM1, I could go on for a long time.

我之前提到的自體免疫性肝炎與自體抗體有關，例如抗 ANA 抗體、抗平滑肌抗體、抗肌動蛋白抗體和抗 LC1 抗體。不過，CIDP 患者中也有較低比例的自身抗體，可能 5% 到 10% 的患者體內存在針對 155 和 CMTM1 這對結節蛋白的自身抗體，我可以​​繼續說下去。

And so this biology being driven by the compartment that UPLIZNA targets makes for a really great chance to extend the benefits of targeting B cells in both of these conditions. Murdo?

因此，這種由 UPLIZNA 靶向的細胞區室驅動的生物學特性，為在這兩種情況下擴大靶向 B 細胞的益處提供了非常好的機會。默多？

Yes. Just the size of the opportunity here is interesting. Roughly the prevalent pool in the US is estimated to be about 35,000 patients, maybe 7,000 to 10,000 incident new diagnosed cases per year in the US. So hopefully, we can develop this drug and offer some benefit for these patients. which is yet another steroid intensive condition, and we believe that we can do better than that.

是的。光是這裡的機會規模就很有吸引力。據估計，美國現有患者群體約有 35,000 人，每年美國可能新增 7,000 至 10,000 例確診病例。所以，我們希望能夠研發出這種藥物，為這些病人帶來一些好處。這又是一種需要大量使用類固醇的疾病，​​我們相信我們可以做得更好。

So let's hope for that best outcome in those clinical trials.

所以，讓我們期待這些臨床試驗能達到最好的結果。

On Repatha, I alluded to what our strategy is in my opening remarks. We are excited by the landmark data that were revealed at the American Heart Association last year in November where we can now clearly promote Repatha for the prevention of first heart attack or first stroke in a high-risk patient population and/or a high-risk primary prevention population.

關於 Repatha，我在開場白中已經暗示了我們的策略是什麼。我們對去年 11 月在美國心臟協會公佈的里程碑式數據感到興奮，現在我們可以明確地推廣 Repatha 用於預防高風險患者群體和/或高風險一級預防人群的首次心臟病發作或首次中風。

And so that is our focus right now, and we are the only PCSK9 that has both secondary and primary prevention data in our label. The VESALIUS data are being met very positively by both cardiologists and primary care physicians, in particular, for the primary care physician for the diabetes patients that were enrolled in the trial who did very well.

所以這就是我們目前的重點，而且我們是唯一一家在標籤中同時擁有二級預防和一級預防數據的 PCSK9 抑制劑。VESALIUS 的數據受到了心臟病專家和初級保健醫生的積極評價，尤其是參與試驗的糖尿病患者的初級保健醫生，他們的治療效果非常好。

So we are focused on making sure there's high awareness of these data.

因此，我們致力於確保人們對這些數據有充分的了解。

Repatha enjoys great access, broadly preferred on national template formularies by PBMs and health plans around the country and around the world. And of course, we know that there is an immense amount of trust now in the profile by prescribers. And for the millions of patients that have received treatment and are taking Repatha, there's strong acceptance that every two-week injection to lower cholesterol to the 45 milligrams per deciliter target dose that was achieved in the Repatha arm in VESALIUS so that patients can reduce their cardiovascular risk.

Repatha 具有很高的可近性，在全國乃至全世界的藥品福利管理機構 (PBM) 和健康計劃的國家級處方集中均被廣泛採用。當然，我們也知道，現在處方醫生對這種模式非常信任。對於數百萬接受過治療並正在服用 Repatha 的患者來說，人們普遍接受每兩週注射一次，將膽固醇降低到 VESALIUS 研究中 Repatha 組達到的每分升 45 毫克的目標劑量，以便患者能夠降低心血管風險。

So we've got a lot to talk about. We've maintained all along that there is a lot of room in this market for other therapies to come in, but they will not have the data package and profile that Repatha has established, and we'll continue to remind prescribers and others about that. Thank you.

所以我們有很多話要說。我們一直認為，這個市場還有很多空間容納其他療法，但它們不會擁有瑞百安所建立的資料包和概況，我們將繼續提醒處方醫生和其他人這一點。謝謝。

Okay. Let's go to the next question.

好的。我們來看下一個問題。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Congrats on the growth progress here. Maybe like just again, the question on PCSK9 and Repatha at this point. So Murdo, can you please remind us what percentage of your prescriptions are coming from primary care at this point? And with the VESALIUS data, like how do you see the primary care segment of the market evolving over time?

恭喜你們取得的成長進展。或許現在的問題又回到了 PCSK9 和 Repatha。默多，請問您能否告知我們目前您的處方中有多少百分比來自基層醫療機構？那麼，根據 VESALIUS 數據，您認為初級保健市場會如何隨時間演變？

Yes. Thanks, Mohit. I put a number out before the VESALIUS data promotion started where roughly 40% of our prescriptions were coming from patients who were considered primary prevention patients who have not yet had an event where physicians were looking to lower those patients' LDL-cholesterol.

是的。謝謝，莫希特。在 VESALIUS 數據推廣開始之前，我曾經公佈過一個數字，大約 40% 的處方來自被認為是初級預防的患者，這些患者還沒有發生過醫生希望降低其 LDL 膽固醇的事件。

I would imagine that that will increase and grow over time. What we are seeing is equal interest, quite frankly, from cardiologists who are excited by the VESALIUS data and the consistency of both the primary endpoint, the secondary endpoint, the MI subgroup, quite frankly, the overall incidence of death in the trial was also something that attracted attention from specialists.

我想隨著時間的推移，這種情況會越來越普遍。坦白說，我們看到心臟科醫生們也同樣對此很感興趣，他們對 VESALIUS 的數據以及主要終點、次要終點、MI 亞組的一致性感到興奮。坦白說，試驗中的整體死亡率也引起了專家們的注意。

So the cardiology group has seen this as an affirmation of what they were already doing and being aggressive in treating LDL cholesterol. And primary care physicians, as I mentioned, are much more intent and aligned to adding Repatha to the optimized statin therapy that most patients are on.

因此，心臟科醫師組認為這是對他們之前所做工作的肯定，也是對他們積極治療低密度脂蛋白膽固醇的肯定。正如我之前提到的，初級保健醫生更傾向於將 Repatha 添加到大多數患者正在接受的優化他汀類藥物治療中。

As for how much, we don't give product-specific guidance, but hopefully, you can tell, I am extremely excited about the momentum that we have on Repatha right now. I'm really pleased with the execution of our teams around the world. We've made incremental investments in advance of the opportunity of promoting the VESALIUS data, and I expect that momentum to continue.

至於具體金額，我們不提供特定產品的指導，但希望您能看出，我對 Repatha 目前的發展勢頭感到非常興奮。我對我們全球團隊的執行非常滿意。我們已經提前進行了一些投資，以抓住推廣 VESALIUS 數據的機會，我預計這種勢頭將會繼續下去。

Louise Chen, Scotiabank.

Louise Chen，加拿大豐業銀行。

I wanted to ask you about TEPEZZA and your thoughts on another potential competitor coming to market. And then also where you stand with AMG 732 for TED.

我想問你關於 TEPEZZA 的情況，以及你對另一個潛在競爭對手進入市場的看法。另外，你對 AMG 732 for TED 的看法如何？

Okay. Great. Maybe again, we could do this in two chunks. Jay, do you want to talk about the clinical piece and then Murdo can talk about the commercial piece.

好的。偉大的。或許我們可以分成兩個部分來完成這項工作。傑伊，你想先談談臨床方面，然後默多再談談商業方面。

Thanks, Louise. TEPEZZA is proving to be just a very important medicine for the management of thyroid eye disease. We have established a very strong evidence base in both the high clinical activity score, lower clinical activity score, patient populations and are quite proud of this data generation and also the apparent impact that it's having on patients being treated today.

謝謝你，路易絲。TEPEZZA 已被​​證明是治療甲狀腺眼疾的一種非常重要的藥物。我們在高臨床活動評分、低臨床活動評分、患者群體方面都建立了非常強有力的證據基礎，我們對這些數據的生成以及它對當今接受治療的患者產生的明顯影響感到非常自豪。

We have an ongoing subcutaneous Phase 3 clinical study in moderate to severe active TED fully enrolled, as we had shared, and we expect to complete this study in the second half of this year. So we have a really terrific medicine that's increasingly a standard of care that's helping a lot of patients and a strong data set that it sits on top of.

正如我們之前分享的那樣，我們目前正在進行一項針對中度至重度活動性 TED 的皮下 3 期臨床研究，該研究已全部招募完畢，我們預計將在今年下半年完成這項研究。所以我們有一種非常棒的藥物，它正日益成為一種標準療法，幫助了許多患者，而且它還有強大的數據支持。

Before handing off to Murdo. I'll just quickly comment on AMG 732. Thank you for noticing. This is an IGF-1R targeting monoclonal antibody, also achieves subcutaneous administration. Phase 2 studies enrolling initially studied to moderate to severe and active TED, and we'll have more to say on that in the future.

在交給默多之前。我只想簡單評論一下AMG 732。謝謝你的關注。這是一種針對IGF-1R的單株抗體，也可進行皮下給藥。第二階段研究最初招募的是中度至重度活動性 TED 患者，我們將來會對此發表更多評論。

Murdo?

默多？

Yes. Thanks, Jay. As Jay mentioned, we're expanding our treatment for patients with thyroid eye disease into the lower clinical activity score patient population, who tends to be managed by different specialists than the higher clinical activity score patients. We have historically been able to drive very strong penetration with ocular plastic surgeons and general ophthalmologists.

是的。謝謝你，傑伊。正如 Jay 所提到的，我們正在將甲狀腺眼疾患者的治療範圍擴大到臨床活動評分較低的患者群體，這些患者往往由與臨床活動評分較高的患者不同的專家進行管理。從歷史上看，我們一直能夠與眼科整形外科醫生和普通眼科醫生建立非常牢固的合作關係。

We are expanding our prescribing base to include endocrinologists. We made investments the beginning of last year, and those investments are starting to return now by an increased base of endocrinologists prescribing. So that's in the US, and we expect that we'll continue to broaden or treatment of the low clinical activity score patients while maintaining our share of the higher clinical activity score patients.

我們正在擴大處方範圍，將內分泌科醫生納入其中。我們去年年初進行了投資，現在隨著內分泌科醫生處方量的增加，這些投資開始獲得回報。所以這是在美國的情況，我們預計我們將繼續擴大對低臨床活動評分患者的治療範圍，同時保持我們對高臨床活動評分患者的份額。

But also our international launches. Our launch in Japan has gone extremely well. We're seeing nice uptake there. We're seeing a very well-received product for higher clinical activities for patients, and we're in the process of launching in multiple markets around the world as we speak.

但也包括我們的國際發表會。我們在日本的發布非常成功。我們看到那裡的市場反應不錯。我們看到該產品在臨床治療方面受到了患者的熱烈歡迎，目前我們正在全球多個市場推出該產品。

So overall, TEPEZZA will be a good growth driver for us this year.

總的來說，TEPEZZA 將成為我們今年的良好成長動力。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

I had one on the MariTide Phase 3 program. Appreciate all the details today, but just was wondering if you have any update in terms of how to think about the design of the type 2 diabetes CVOT trial, particularly the control arm, as I know that's something that you guys were debating here post the -- seeing some of the data from some of the competitors, but just wondering how you're thinking about control arm in that setting.

我參加了 MariTide 第三階段計畫。感謝您今天提供的所有細節，但我只是想知道您在如何考慮 2 型糖尿病 CVOT 試驗的設計方面是否有任何最新進展，特別是對照組，因為我知道這是你們在看到一些競爭對手的數據後一直在討論的問題，但我只是想知道在這種情況下，你們是如何考慮對照組的。

Sure. Jay, do you want to --

當然。傑伊，你想…--

Sure. I'm happy to share, Terence. We're just thrilled by the opportunity to develop MariTide for patients with type 2 diabetes. And this is really where we see a potential paradigm shift in the management of that disease. In my medical training, we practice with insulin and insufficient orals and titrating dosing.

當然。樂意分享，特倫斯。我們非常高興有機會為第 2 型糖尿病患者開發 MariTide。而這正是我們看到疾病管理方式可能出現典範轉移的地方。在我的醫學訓練中，我們練習使用胰島素和口服藥物不足，並進行劑量調整。

And here, we have a medicine that can be dosed monthly. We've seen efficacy in chronic weight management bi-monthly. We've recently described maintenance approach using quarterly dosing. This is just the new paradigm in the management of diabetes.

而我們現在有一種可以每月服用一次的藥物。我們已經看到，每兩個月進行一次慢性體重管理，效果顯著。我們最近介紹了一種採用季度給藥方式的維護方法。這只是糖尿病管理的新模式。

We've shared the major insights at JPMorgan from the Phase 2 type 2 diabetes study, which is ongoing. There are additional parts to this trial. It's importantly given us an experience with low BMI patients and also seeing A1c across the dose range.

我們已在摩根大通分享了正在進行的 2 期 2 型糖尿病研究的主要見解。本次審判還有其他部分。更重要的是，它讓我們累積了治療低 BMI 患者的經驗，並觀察到了不同劑量範圍內的 A1c 水平。

And so the robust findings of this trial position us very well to start to pursue Phase 3 clinical investigation. The specific design of these studies, control arms and the patients recruited will be a subject for a future engagement.

因此，這項試驗的可靠結果為我們進行 3 期臨床研究奠定了良好的基礎。這些研究的具體設計、對照組以及招募的患者將是未來討論的主題。

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

Just another MariTide question and just on the topic of less frequent than monthly dosing. It certainly seems like there could be a trade-off here where even more infrequent dosing would obviously be a huge benefit even if it was associated with a bit less weight loss.

關於 MariTide 的另一個問題，是關於低於每月一次給藥頻率的給藥方式。這裡似乎存在著一種權衡，即使減少服藥頻率會導致體重減輕一些，但顯然也會帶來巨大的好處。

I guess so as you think about just pushing the program beyond monthly, what profile do you think you'd need to see for that to have a role in the market? Are there minimum efficacy bars you're looking at? And just in general, what is your confidence about the ability to push this beyond monthly?

我想，如果您考慮將該計劃的周期延長到每月之外，您認為需要什麼樣的用戶群體才能在市場上佔有一席之地？你們有設定最低效能標準嗎？總的來說，您對將這一目標實現頻率提高到每月一次以上有多大信心？

Okay. That's an interesting question. Murdo, do you want to take a shot at what we think we see in the marketplace and why we believe MariTide has the potential to address what is emerging as a very large unmet need in the field?

好的。這是一個有趣的問題。Murdo，你想嘗試談談我們對市場現狀的看法，以及我們為什麼認為 MariTide 有潛力解決該領域正在出現的巨大未滿足需求嗎？

Yes, I'll make a few comments here, Bob. Thanks for the opportunity. I think it's pretty clear as we look at the market as it exists today, that there's dissatisfaction with the weekly GLP-1s. And I think you can actually see that in a fairly dramatic way with the advent of oral sema and how rapidly it's been taken up in the market. That tells you that clearly, patients and prescribers are looking for other opportunities.

是的，鮑勃，我在這裡要補充幾點。謝謝您給我這個機會。我認為，從目前的市場情況來看，很明顯，人們對每週注射的 GLP-1 感到不滿。我認為，隨著口服塞馬西平的出現以及它在市場上迅速普及，這一點就體現得相當明顯。這清楚地表明，患者和處方醫生都在尋找其他機會。

Now what I like is the opportunity that we have to deliver what has been mentioned a couple of times in this call as a paradigm-changing therapy. And that's the ability to come into a weekly market, bring a monthly therapy that can achieve similar weight loss in a very well-tolerated regimen. And then for those patients who achieve their weight goal for them to convert to every 8-week or every 12-week dosing regimen to maintain that weight and/or the metabolic benefits of their therapy.

現在我很高興我們有機會提供在這次通話中多次提到的、具有變革意義的療法。這就是每週進入市場，推出每月一次的療法，以非常良好的耐受性達到類似的減肥效果的能力。然後，對於那些達到體重目標的患者，可以將其改為每 8 週或每 12 週一次的給藥方案，以維持體重和/或獲得治療的代謝益處。

And I think that's a pretty compelling offering. I think that we're targeting that kind of profile, and we'll have multiple ways of generating data to that effect.

我認為這是一個相當有吸引力的提議。我認為我們的目標客戶群正是這類人群，我們將採用多種方式來收集相關數據。

Chris, maybe we have Jay just address the piece as well. Go ahead.

克里斯，或許我們可以讓傑伊也談談這件事。前進。

Yes, Chris, thanks for the question. If you don't mind, I'm going to reject part of the premise of your question. This idea of less frequent dosing being an absolute trade-off for efficacy. We're not certain that we will see that, having observed the large majority of patients maintaining weight on low dose and on quarterly dosing.

是的，克里斯，謝謝你的提問。如果你不介意的話，我想反駁你問題的部分前提。減少給藥頻率是提高療效的絕對代價。我們不確定是否會看到這種情況，因為我們觀察到絕大多數患者在低劑量和每季給藥的情況下都能維持體重。

In the field of obesity, they call this a defended fat mass and the capacity to avoid weight regain is a sign that the reset of body weight has been achieved. We have seen with all medicines to date, dose-ranging effects on weight loss. And here, we might expect to see schedule ranging effects on weight loss that would be individualized for patients. And so I wouldn't necessarily assume that we'll see a big trade-off with less frequent dosing of MariTide.

在肥胖領域，他們稱之為“防禦性脂肪量”，避免體重反彈的能力表明體重重置已經實現。到目前為止，我們已經看到所有藥物對減肥效果都存在劑量範圍效應。在這裡，我們可能會看到不同的治療方案對減重效果的影響，而這種效果需要根據患者的具體情況而定。因此，我並不認為減少 MariTide 的給藥頻率會帶來很大的權衡。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

I'm really, really lost today. I'm trying to figure out what happened all of a sudden. Why did FDA decide to ask you to pull the ChemoCentryx drug? Was there some litigation or some correspondent -- like what prompted it in the first place?

我今天真的非常迷茫。我正在努力弄清楚到底發生了什麼事。FDA為什麼決定要你們撤回ChemoCentryx藥物？是有什麼訴訟或某個通訊員之類的──是什麼引發了這件事？

And then if I dig in a little more specifically, they're saying that nine patients need to be readjudicated. Is that referring to the primary endpoint on week 26 remission or the week 52 sustained remission? I asked because the week 26 endpoint was not inferior anyway. So even if you re-adjudicate those, it's still not inferior. So I'm just really lost today.

如果我進一步深入調查，他們說有九名患者需要重新審理。這是指第 26 週緩解的主要終點，還是第 52 週持續緩解？我這麼問是因為第 26 週的終點指標並不遜色。所以即使你重新裁決這些，它仍然不遜色。我今天真的覺得很迷惘。

Okay. Well, Jay -- I'll ask Jay to address the question. You may want to just start at the high altitude to remind people what TAVNEOS is. Say a few words about the disease that it addresses. It's obviously a very small product in our portfolio relative to the other things we have going on. But it may be a medicine that's less familiar to most of our callers.

好的。好的，傑伊——我會請傑伊來回答這個問題。您可以先從高海拔地區開始，提醒人們 TAVNEOS 是什麼。請簡單介紹一下它所針對的疾病。顯然，相對於我們正在進行的其他項目而言，它在我們產品組合中佔比很小。但對我們大多數的來電者來說，這可能是一種不太熟悉的藥物。

Yes, sure. Thanks, Umer. And just by way of background then. ANCA-associated vasculitis is a group of very serious, rare and destructive inflammatory illnesses that targets blood vessels and can, therefore, damage vital organs like kidney, lung, skin, nerves, even heart. The prior treatment paradigm for TAVNEOS was quite toxic, cyclophosphamide chemotherapy with azathioprine and rituximab, accompanied by long-term steroid use and chronic use of steroids proved very common, but also very challenging.

當然可以。謝謝你，烏默。以上僅是背景介紹。ANCA 相關性血管炎是一組非常嚴重、罕見且具有破壞性的發炎性疾病，它會攻擊血管，因此會損害腎臟、肺部、皮膚、神經甚至心臟等重要器官。TAVNEOS 的先前治療方案毒性很大，環磷酰胺化療合併硫唑嘌呤和利妥昔單抗，同時長期使用類固醇，慢性使用類固醇非常普遍，但也極具挑戰性。

Hypoglycemia, lipodystrophy, bone health, mood disorders, immune suppression. And then enter TAVNEOS or avacopan. This is an oral complement [Factor 5a] receptor blocker, and so it blocks complement-mediated destruction.

低血糖、脂肪營養不良、骨骼健康、情緒障礙、免疫抑制。然後輸入 TAVNEOS 或 avacopan。這是一種口服補體（因子 5a）受體阻斷劑，因此可以阻斷補體介導的破壞作用。

We acquired TAVNEOS from ChemoCentryx in 2022 after we've been on the market for a year, based on approval for the ADVOCATE Phase 3 study that you referenced as published in the New England Journal. This established the efficacy of TAVNEOS over prednisone steroid tapering for sustained remission out to 52 weeks when it was added to induction therapy with at that time, standard of care, rituximab and cyclophosphamide.

我們於 2022 年從 ChemoCentryx 收購了 TAVNEOS，此前我們的產品已上市一年。此次收購是基於您在《新英格蘭醫學雜誌》上引用的 ADVOCATE 3 期研究的批准。這證實了 TAVNEOS 在誘導治療中與當時的標準療法利妥昔單抗和環磷酰胺聯合使用時，在 52 週內持續緩解的療效優於潑尼松類固醇減量療法。

As we shared, the FDA requested a voluntary withdrawal in January 16. We were surprised by this, there were concerns raised by the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients. And we're in discussions with FDA, and we'll answer questions as we talk with them.

正如我們之前報道的，FDA於1月16日要求該公司自願撤回申請。我們對此感到驚訝，ChemoCentryx 對 331 名患者中的 9 名患者的主要終點結果進行重新裁定的過程引起了人們的擔憂。我們正在與FDA進行討論，我們會邊討論邊回答問題。

Alex Hammond, Wolfe Research.

Alex Hammond，Wolfe Research。

So you did a strong quarter with PAVBLU. I guess, how do you kind of expect to maintain this leadership position when other manufacturers launch their biosimilars in the second half of the year? I guess essentially, can you kind of help level set growth expectations for this year?

所以你們PAVBLU這個季度表現很出色。我想問的是，當其他製造商在下半年推出生物相似藥時，你們打算如何保持這種領先地位？我想問的是，您能否幫忙設定今年的成長預期？

Well, obviously, we're not giving guidance on an individual product, Alexandria. But Murdo, go ahead and talk a little bit about the strong performance that we've observed so far with our biosimilar PAVBLU.

顯然，我們不會針對個別產品提供指導，亞歷山德里亞。但 Murdo，請您談談我們迄今為止在生物相似藥 PAVBLU 方面所觀察到的強勁表現。

Yes. I think what we've been able to do thus far is establish good inroads with the largest national retina specialist networks. And I think what I would say is they tend to want to pick a product that they know allows them to manage their patients effectively. We think we've got a great device that helps them do that.

是的。我認為到目前為止，我們已經取得的成就是與全國最大的視網膜專科醫生網絡建立了良好的合作關係。我認為，他們往往希望選擇一款能幫助他們有效管理患者的產品。我們認為我們研發了一種很棒的設備，可以幫助他們做到這一點。

We obviously are competing effectively against the innovator. And given that we have a lot of biosimilar experience, we'll compete effectively when others enter the market whenever that may be.

我們顯然正在與創新者展開有效的競爭。鑑於我們在生物相似藥方面擁有豐富的經驗，無論何時其他公司進入市場，我們都能有效地參與競爭。

Okay. We'll take one last question as we're right up against the bottom of the 30-minute mark here or the hour. So why don't we take one last question? And then as always, Casey and his team will be around to answer questions if we didn't get to you on this call.

好的。我們現在即將達到30分鐘或整點，所以我們再回答最後一個問題。那麼，我們何不回答最後一個問題呢？如果這次電話會議我們沒能問到您的問題，Casey 和他的團隊也會像往常一樣隨時為您解答。

Julianne, last question.

朱莉安娜，最後一個問題。

Courtney Breen, Bernstein.

Courtney Breen，Bernstein。

I am going to bounce you back to MariTide. And just as we think about maintenance and that kind of less frequent dosing opportunity, can you describe how you might think about the role of this product in the market? Is it only post MariTide weight loss? Or how should we be thinking about kind of that switching opportunity and the type of data that you might demonstrate for that positioning over time?

我要把你送回MariTide。正如我們考慮維持治療和減少用藥頻率的機會一樣，您能否描述一下您認為產品在市場上的作用？是否僅在 MariTide 減肥後才會出現這種情況？或者，我們應該如何看待這種轉變機會，以及隨著時間的推移，您可以展示哪些類型的數據來證明這種定位？

I can imagine there's probably a lot of interest in that. Murdo, do you want to share any thoughts at this point?

我想大家應該對此很有興趣。Murdo，你現在有什麼想法想分享嗎？

Well, thanks, Courtney. Obviously, we think we've got -- as has been said now many times, and I'll repeat it again, a product that changes the paradigm of weight loss diabetes, ASCVD, heart failure management. And we see it as both an effective product to start patients on to get to weight goal and also for patients who receive the medical benefit of their treatment need to be on these therapies for multiple years.

謝謝你，考特尼。顯然，我們認為我們已經擁有了——正如之前多次說過的那樣，我再重複一遍——一種改變了減肥、糖尿病、ASCVD、心臟衰竭管理模式的產品。我們認為它既是幫助患者達到體重目標的有效產品，也是那些需要多年接受治療才能獲得醫療益處的患者的有效產品。

This opportunity for MariTide profile to deliver a convenient, well-tolerated efficacious regimen that could be monthly, could be every eight weeks and could be quarterly. We think that's really exciting.

MariTide 的這項特性使其有機會提供一種方便、耐受性良好且有效的治療方案，該方案可以每月一次、每八週一次或每季一次。我們認為這真是太令人興奮了。

And then, of course, as you hinted that, there may be patients out there on other therapies that want to switch to something as convenient and as well tolerated as MariTide. So the answer is all of the above.

當然，正如您所暗示的，可能有些正在接受其他療法的患者想要改用像 MariTide 這樣方便且耐受性良好的療法。所以答案是以上所有選項。

Okay. So again, thank you all for your interest. I appreciate you joining our call. I'll just reiterate if we didn't get to you, please reach out directly to Casey and his team.

好的。再次感謝大家的關注。感謝您參加我們的電話會議。我再次重申，如果我們沒有聯絡到您，請直接聯絡 Casey 和他的團隊。

In the meanwhile, I hope we've left you confident about the momentum that we're carrying into 2026. And again, I would just reiterate that we're excited about the year that we have in prospect here. A year, which, as Peter has described, we view as a springboard to the future growth here at Amgen.

同時，我希望我們已經讓你們對我們邁向 2026 年的良好勢頭充滿信心。我再次重申，我們對即將到來的一年充滿期待。正如彼得所描述的那樣，我們認為這一年是安進未來發展的跳板。

So excited about the hand that we have and look forward to sharing with you during the course of the year. Thank you.

對我們目前的情況感到非常興奮，期待在這一年中與大家分享。謝謝。

This concludes our Amgen Q4 2025 earnings conference call. You may now disconnect.

安進公司2025年第四季財報電話會議到此結束。您現在可以斷開連線了。