美國安進 (AMGN) 2025 Q1 法說會逐字稿

My name is Julianne, and I will be your conference facilitator today for the Amgen's Q1 FY 2025 earnings conference call. (Operator Instructions)

我叫朱莉安，今天我將擔任安進 2025 財年第一季財報電話會議的主持人。（操作員指示）

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

現在我想介紹投資者關係副總裁賈斯汀·克萊斯 (Justin Claeys)。克萊斯先生，現在可以開始了。

Good afternoon, and welcome to our first quarter 2025 earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Murdo Gordon, Jay Bradner and Peter Griffith. 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 accompany 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.

下午好，歡迎參加我們 2025 年第一季財報電話會議。鮑勃·布拉德威 (Bob Bradway) 將主持電話會議，隨後默多·戈登 (Murdo Gordon)、傑伊·布拉德納 (Jay Bradner) 和彼得·格里菲斯 (Peter Griffith) 對我們的表現進行更廣泛的回顧。在今天的討論過程中，我們將使用非公認會計準則財務指標來描述我們的業績，並在本次電話會議隨附的資料中提供適當的對帳。我們還將做出一些前瞻性陳述，這些陳述受我們的安全港聲明的限制，請注意實際結果可能會發生重大差異。

Over to you, Bob.

交給你了，鮑伯。

Okay. Good afternoon, everyone, and thank you for joining us today. We're off to a strong start in 2025, and this was an exciting quarter, one with strong volume growth across the enterprise, important new product launches and positive Phase 3 data.

好的。大家下午好，感謝大家今天的參與。我們在 2025 年迎來了強勁的開端，這是一個令人興奮的季度，整個企業的銷量強勁增長，重要的新產品發布和積極的第三階段數據。

Revenue grew 9% year over year, volume grew 14%, reflecting growing patient demand for our innovative medicines. 14 of our medicines delivered double-digit sales growth spanning general medicine, rare disease, inflammation and oncology. Our industry-leading biosimilars portfolio added to this performance, delivering more than $700 million in revenue this quarter, which was up 35% year over year. Beyond the strong financials, this quarter demonstrated the breadth and depth of our portfolio and the strength of our execution. We delivered multiple positive Phase 3 readouts, initiated four new Phase 3 studies and launched three new products or indications.

營收年增 9%，銷量成長 14%，反映出患者對我們創新藥物的需求不斷增長。我們的 14 種藥物實現了兩位數的銷售成長，涵蓋普通藥物、罕見疾病、發炎和腫瘤學。我們業界領先的生物相似藥產品組合進一步提升了業績，本季營收超過 7 億美元，年增 35%。除了強勁的財務狀況外，本季還展示了我們產品組合的廣度和深度以及執行力的實力。我們發布了多份積極的 3 期研究報告，啟動了四項新的 3 期研究，並推出了三種新產品或適應症。

With that, let me turn to some of the key drivers of our momentum. Starting in General Medicine, we're addressing large, underserved patient populations with multiple products, which have significant room for growth. Heart disease remains the leading cause of death globally. Repatha, now a multibillion-dollar product, continues to grow as access improves for patients. We're also advancing the Olpasiran clinical program, which addresses an important residual risk factor in heart disease.

接下來，讓我來談談我們發展勢頭的一些關鍵驅動因素。從普通醫學開始，我們透過多種產品來解決大量服務不足的患者群體的問題，這些產品具有很大的成長空間。心臟病仍然是全球最大的死亡原因。Repatha 現已成為價值數十億美元的產品，隨著患者獲得藥物的機會不斷改善，其銷售額仍在持續成長。我們也正在推進 Olpasiran 臨床項目，該項目旨在解決心臟病的一個重要殘留風險因素。

It's currently being evaluated in a large Phase 3 cardiovascular outcomes trial. In bone health, Amgen is the global leader, and we expect continued long-term growth in this area. EVENITY, which is the only bone builder, which also slows bone loss, reduces fracture risk for millions of postmenopausal women. We're rapidly advancing MariTide, having initiated the first chronic weight management Phase 3 studies of our broad clinical program in obesity and obesity-related conditions.

目前，正在進行一項大型 3 期心血管結果試驗來評估它。在骨骼健康領域，安進是全球領導者，我們預計該領域將繼續長期成長。EVENITY 是唯一能夠減緩骨質流失的骨骼生成劑，可降低數百萬停經後婦女的骨折風險。我們正在快速推進 MariTide，並已啟動針對肥胖和肥胖相關疾病的廣泛臨床計劃的首個慢性體重管理 3 期研究。

Turning to rare disease. Our four key growth drivers: TEPEZZA, KRYSTEXXA, UPLIZNA and TAVNEOS, are all early in their life cycles and well positioned for long-term growth. UPLIZNA is a differentiated B-cell depleting therapy. It's the leading biologic for the treatment of NMOSD and recently launched as the first and only FDA-approved treatment for IgG4-related disease, which is a serious and underserved autoimmune condition. We're encouraged by the positive reception from patients and physicians in the early stage of the launch.

轉向罕見疾病。我們的四個關鍵成長動力：TEPEZZA、KRYSTEXXA、UPLIZNA 和 TAVNEOS，均處於生命週期的早期階段，並且為長期成長做好了準備。UPLIZNA 是一種分化型 B 細胞耗竭療法。它是治療 NMOSD 的領先生物製劑，最近作為第一個也是唯一一個獲得 FDA 批准的治療 IgG4 相關疾病的藥物推出，IgG4 相關疾病是一種嚴重且治療不足的自身免疫性疾病。在產品推出的初期，患者和醫生的正面回饋令我們感到鼓舞。

We've also filed Phase 3 data for UPLIZNA and generalized myasthenia gravis with the FDA and – we’re exploring its potential across additional B-cell-mediated diseases. In inflammation, we remain focused on difficult-to-treat diseases where the need for innovation is the highest. TEZSPIRE is a first-in-class therapy that targets TSLP, a differentiated mechanism with broad potential across a number of diseases. In severe asthma, it continues to build strong momentum with high prescriber confidence. We've also delivered compelling Phase 3 data in chronic rhinosinusitis with nasal polyps and most recently, initiated two pivotal Phase 3 studies in COPD, the world's third leading cause of death.

我們也向 FDA 提交了 UPLIZNA 和全身性重症肌無力的 3 期數據，並且我們正在探索其在其他 B 細胞介導疾病中的潛力。在發炎領域，我們仍然專注於最需要創新的難治疾病。TEZSPIRE 是針對 TSLP 的首創療法，TSLP 是一種在多種疾病中具有廣泛潛力的差異化機制。在嚴重氣喘方面，該藥物持續保持強勁勢頭，處方醫生對此充滿信心。我們還提供了有關伴有鼻息肉的慢性鼻竇炎的令人信服的 3 期數據，最近，我們啟動了兩項有關慢性阻塞性肺病（世界第三大死亡原因）的關鍵 3 期研究。

In oncology, our leading bispecific T cell engager platform continues to develop new standards of care. BLINCYTO has moved into frontline treatment and continues to grow. The FDA has granted breakthrough therapy designation for blinatumomab for subcutaneous treatment of B-ALL, which Jay will speak to shortly. IMDELLTRA provided an overwhelming survival benefit at an interim analysis in a Phase 3 study in second-line small cell lung cancer, beating chemotherapy as a standard of care. These data represent a meaningful milestone for patients and will be presented at ASCO in June. Xaluritamig is enrolling well in our Phase 3 study in advanced prostate cancer patients.

在腫瘤學領域，我們領先的雙特異性 T 細胞接合平台不斷開發新的護理標準。BLINCYTO 已進入第一線治療領域並持續發展。FDA 已授予 blinatumomab 用於皮下治療 B-ALL 的突破性療法認定，Jay 稍後將對此進行介紹。IMDELLTRA 在第二線小細胞肺癌的 3 期研究中期分析中提供了壓倒性的生存益處，優於化療作為標準治療方法。這些數據對於患者來說是一個有意義的里程碑，並將於 6 月在 ASCO 上公佈。Xaluritamig 在我們針對晚期前列腺癌患者的 3 期研究中招募情況良好。

Next, our industry-leading biosimilars portfolio continues to contribute meaningfully to our long-term growth. We have a proven approach in this area, be in the first wave of U.S. launches and ensure a safe and reliable supply. We're seeing that formula deliver again this quarter with our next wave of U.S. launches underway, including PAVBLU, WEZLANA and BKEMV. I recognize there's a lot of uncertainty at the moment related to tariffs and taxes.

其次，我們領先業界的生物相似藥產品組合將繼續為我們的長期成長做出有意義的貢獻。我們在這一領域擁有行之有效的方法，處於美國首波發射浪潮之中，並確保了安全可靠的供應。本季度，隨著我們下一波美國產品的推出，包括 PAVBLU、WEZLANA 和 BKEMV，我們再次看到這個模式發揮了作用。我認識到目前關稅和稅收方面存在許多不確定性。

Given the long life cycle of our business, clarity on these issues is important to us, and I'm sure it's important to all of you as well. While it's premature to speculate what the outcomes of tariffs and taxes might be for our business, I would remind you that we've proven our ability to adapt, and we've demonstrated the operating agility necessary to navigate change and deliver long-term growth.

鑑於我們業務的長期生命週期，明確這些問題對我們來說很重要，我相信這對你們所有人來說也很重要。雖然現在猜測關稅和稅收會對我們的業務產生什麼影響還為時過早，但我要提醒大家，我們已經證明了我們的適應能力，並且展示了應對變化和實現長期增長所必需的營運靈活性。

With respect to manufacturing, I want to point out that following the 2017 tax reform we invested nearly $5 billion in U.S. capital projects as measured through 2024. And in addition, we've recently announced nearly $2 billion in additional expansions in the states of Ohio and North Carolina. We're actively engaged on policy matters, and we remain focused on meeting the growing demand for our medicines. And to the extent that changes in taxes or tariffs require us to adapt, we'll do so accordingly.

關於製造業，我想指出，根據 2017 年稅制改革的數據，到 2024 年，我們在美國資本項目的投資將接近 50 億美元。此外，我們最近也宣佈在俄亥俄州和北卡羅來納州額外投資近 20 億美元進行擴張。我們積極參與政策事務，並始終致力於滿足日益增長的藥品需求。如果稅金或關稅的變化需要我們做出調整，我們也會做出相應的調整。

Let's go back to where I started. This was an exciting quarter, not just because of the financial results, but because of what those results signal about our future. In-line brands are delivering. We're advancing positive Phase 3 studies. We're launching new products.

讓我們回到我開始的地方。這是一個令人興奮的季度，不僅因為財務業績，還因為這些業績預示著我們的未來。同線品牌正在交付產品。我們正在推進積極的第三階段研究。我們正在推出新產品。

We're earning breakthrough designations, and we're initiating the next wave of late-stage programs. We're operating in a volatile environment, but what hasn't changed is the growing patient demand for our medicines and the unwavering focus of our people. Amgen is well positioned to deliver innovation and growth, not just this year, but for the long term. And I want to thank our nearly 28,000 colleagues around the world for their dedication to our mission serving patients.

我們正在獲得突破性的稱號，並正在啟動下一波後期專案。我們在一個動盪的環境中運營，但不變的是患者對我們藥品日益增長的需求以及我們員工堅定不移的專注。安進已做好準備，不僅在今年，而且在長期內實現創新和成長。我還要感謝我們遍佈全球的近 28,000 名同事，感謝他們為患者服務，並履行我們的使命。

With that, I'll turn it over to Murdo for a commercial update.

有了這些，我將把它交給 Murdo 進行商業更新。

Thanks, Bob. We've entered 2025 with strong momentum driven by strategic focus, disciplined execution and an unwavering commitment to the patients we serve. In the first quarter, Global Product sales grew 11% year over year. In the US, our largest region, product sales grew 14%. Globally, 14 products delivered double-digit or better growth, underscoring the breadth and depth of our portfolio and ability to deliver consistently and at scale.

謝謝，鮑伯。在戰略重點、嚴格執行和對患者堅定不移的承諾的推動下，我們已進入 2025 年，勢頭強勁。第一季度，全球產品銷售額年增11%。在我們最大的市場美國，產品銷售額成長了 14%。在全球範圍內，有 14 種產品實現了兩位數或更高的成長，凸顯了我們產品組合的廣度和深度以及持續大規模交付的能力。

Turning to General Medicine. Repatha sales increased 27% year over year, delivering $656 million in sales in the first quarter. Repatha is a brand built on deep clinical conviction. We're making meaningful improvements in access, helping more patients benefit from Repatha. With 100 million patients globally in need of effective LDL and cholesterol lowering, we see significant opportunity ahead to further broaden our impact and deliver long-term growth.

轉向普通醫學。Repatha 的銷售額年增 27%，第一季的銷售額達到 6.56 億美元。Repatha 是一個建立在深厚臨床信念的品牌。我們正在對獲取途徑做出有意義的改進，幫助更多患者受益於 Repatha。全球有 1 億患者需要有效降低 LDL 和膽固醇，我們看到未來有進一步擴大影響力和實現長期成長的巨大機會。

In the US, Repatha sales grew 26% in the first quarter with volume up 42%. This growth reflects steady expansion in the base of primary care prescribers and enhanced depth of prescribing amongst cardiologists. We're driving increased patient activation through direct-to-consumer efforts, leading more patients living with cardiovascular disease to ask their physicians about Repatha. Access in the US has never been stronger with many payers eliminating prior authorization requirements making Repatha more accessible and affordable for patients.

在美國，Repatha 第一季的銷售額成長了 26%，銷量成長了 42%。這一增長反映了初級保健處方人員基礎的穩定擴大和心臟病專家處方深度的增強。我們正在透過直接面向消費者的努力來提高患者的積極性，讓更多患有心血管疾病的患者向他們的醫生諮詢有關 Repatha 的信息。美國的藥物取得管道從未如此暢通，許多付款人取消了事先授權要求，使患者更容易獲得 Repatha 並負擔得起。

Outside the US, Repatha continues to deliver strong growth across major markets demonstrating sustained leadership amidst rising competition in the segment. EVENITY sales increased 29% year over year to $442 million in the first quarter. EVENITYis the only therapy that builds new bone and slows bone loss, uniquely positioning it to help reduce fracture risk in women who are postmenopausal. Despite this clear clinical value, fewer than 250,000 patients in the US have been treated to date, while millions remain at risk.

在美國以外的主要市場，Repatha 繼續保持強勁成長，在日益激烈的市場競爭中展現出持續的領導地位。EVENITY 第一季銷售額年增 29%，達到 4.42 億美元。EVENITY 是唯一能夠建立新骨並減緩骨質流失的療法，其獨特優勢使其能夠幫助降低停經後女性的骨折風險。儘管有明顯的臨床價值，但迄今為止，美國接受治療的患者不到 25 萬，數百萬患者仍然處於危險之中。

Today, more than 90% of very high-risk patients are not receiving appropriate therapy and that's a significant gap and a meaningful opportunity to drive growth by ensuring more patients receive the protection they deserve from EVENITY. In the US, EVENITY delivered 36% sales growth in the first quarter. And we focused our US bone field force on EVENITY and increased investment in brand awareness. These efforts are driving meaningful growth in prescription volume across established and newly activated prescriber accounts. Prolia sales grew 10% year over year in the first quarter, with 13% volume growth, reaching almost $1.1 billion in sales.

如今，超過 90% 的高風險患者沒有接受適當的治療，這是一個巨大的差距，也是一個透過確保更多患者從 EVENITY 獲得應有的保護來推動成長的有意義的機會。在美國，EVENITY 第一季的銷售額成長了 36%。而我們將美國骨科領域的力量集中在EVENITY上，並加大了品牌知名度的投入。這些努力正在推動已建立和新啟動的處方帳戶的處方量顯著增長。Prolia 第一季的銷售額年增 10%，銷量成長 13%，達到近 11 億美元。

I'll move to our rare disease portfolio, which grew 3% year over year, delivering $1 billion in sales in the quarter. I would note that within this portfolio, sales of TEPEZZA and KRYSTEXXA were adversely impacted in the quarter by changes to US wholesaler inventory levels. We do not expect similar reductions in inventory levels for the remainder of the year. Since launch, TEPEZZA has had a positive impact for thousands of patients living with thyroid eye disease.

我將轉到我們的罕見疾病產品組合，該產品組合年增 3%，本季銷售額達 10 億美元。我想指出的是，在這個產品組合中，TEPEZZA 和 KRYSTEXXA 的銷售在本季度受到美國批發商庫存水準變化的不利影響。我們預計今年剩餘時間內庫存水準不會出現類似的下降。自推出以來，TEPEZZA 已為數千名患有甲狀腺眼疾的患者帶來了正面影響。

In the US, there are roughly 100,000 patients suffering from TED who could benefit from TEPEZZA and to reach them, we've intensified our efforts to engage a broad prescriber base of oculoplastic surgeons, ophthalmologists and endocrinologists.

在美國，大約有 10 萬名患有 TED 的患者可以從 TEPEZZA 中受益，為了惠及他們，我們加大了力度，與廣泛的眼整形外科醫生、眼科醫生和內分泌學家進行合作。

We're encouraged by the feedback that we're receiving from the medical community, including an increase in intent to prescribe reported by endocrinologists during the first quarter. Access has also improved for patients with more than 85% of medical plans, removing clinical activity score requirements. We're advancing our international expansion of TEPEZZA. In Japan, TEPEZZA is now the first and only approved therapy for active thyroid eye disease. And in the first full quarter since launch, we've seen strong uptake and positive physician engagement.

我們從醫學界收到的回饋令我們感到鼓舞，包括第一季內分泌學家報告的開藥意圖增加。對於擁有超過 85% 醫療計劃的患者來說，其就醫機會也得到了改善，取消了臨床活動評分要求。我們正在推進 TEPEZZA 的國際擴張。在日本，TEPEZZA 是目前第一個也是唯一一個核准治療活動性甲狀腺眼疾的藥物。自推出以來的第一個完整季度，我們看到了強勁的採用率和積極的醫生參與。

In the European Union, we're preparing to launch following the recent positive opinion issued by the Committee for Medicinal Products for Human Use on the approval of TEPEZZA for the treatment of moderate to severe thyroid eye disease in adults. This marks a significant step forward for patients living with TED who currently have no approved disease-modifying therapies available to them in Europe.

在歐盟，我們正準備根據人用藥品委員會最近發布的積極意見，批准 TEPEZZA 用於治療成人中度至重度甲狀腺眼疾。對於目前在歐洲尚無核准的 TED 疾病改良療法的患者來說，這標誌著向前邁出的重要一步。

UPLIZNA sales increased 14% year over year to $91 million in the first quarter, driven by continued growth in treating patients with neuromyelitis optica spectrum disorder. In April, UPLIZNA was the first approved breakthrough therapy in the US for the treatment of adults with immunoglobulin G4 related disease or IgG4, a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The launch is underway in the first patient with IgG4 disease was treated shortly after approval.

第一季度，UPLIZNA 的銷售額年增 14%，達到 9,100 萬美元，這得益於視神經脊髓炎譜系障礙患者治療業務的持續成長。今年 4 月，UPLIZNA 成為美國首個獲準的突破性療法，用於治療成人免疫球蛋白 G4 相關疾病或 IgG4，這是一種慢性、使人衰弱的免疫介導發炎疾病，可影響多個器官。該產品上市後不久便對首位 IgG4 疾病患者進行了治療。

Amgen's many years of experience with rheumatologists have been helpful in establishing urgency to diagnose and treat patients suffering from IgG4-related disease with UPLIZNA. In inflammation, TEZSPIRE delivered another strong quarter, up 65% year over year adoption among pulmonologists is growing, driven by TEZSPIRE's unique profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma.

安進公司與風濕病學家合作多年的經驗有助於緊急使用 UPLIZNA 診斷和治療患有 IgG4 相關疾病的患者。在發炎領域，TEZSPIRE 在本季度再次表現強勁，同比增長 65%，由於 TEZSPIRE 具有治療患有多種誘因和嚴重不受控制的哮喘驅動因素的患者的獨特優勢，因此肺科醫生對該藥物的採用率正在不斷增長。

We see significant growth opportunity for TEZSPIRE to treat the 2.5 million patients worldwide who suffer from this challenging disease. Our innovative oncology portfolio, including BLINCYTO, IMDELLTRA, LUMAKRAS, Vectibix, KYPROLIS, Nplate and XGEVA grew 10% year over year generating over $2 billion in sales in the quarter. At the core of this growth is our industry-leading bispecific T cell engager platform, which developed both BLINCYTO and IMDELLTRA.

我們看到 TEZSPIRE 具有巨大的成長機會，可以為全球 250 萬名患有這種棘手疾病的患者提供治療。我們的創新腫瘤學產品組合，包括 BLINCYTO、IMDELLTRA、LUMAKRAS、Vectibix、KYPROLIS、Nplate 和 XGEVA，在本季度年增 10%，銷售額超過 20 億美元。這一成長的核心是我們業界領先的雙特異性 T 細胞接合平台，該平台開發了 BLINCYTO 和 IMDELLTRA。

With these products, we're not only addressing critical unmet needs in oncology. We're helping to redefine the standard of care in difficult-to-treat cancers, creating meaningful opportunities to reach more patients and drive long-term growth. BLINCYTO sales were $370 million in the quarter with year over year growth of 52%, driven by broad prescribing across both academic and community segments. We see strong conviction in BLINCYTO as the standard of care for both adults and pediatric patients with Philadelphia chromosome-negative B-cell ALL.

透過這些產品，我們不僅解決了腫瘤學領域尚未滿足的關鍵需求。我們正在幫助重新定義難治癌症的治療標準，創造有意義的機會來接觸更多的患者並推動長期成長。本季度，BLINCYTO 的銷售額為 3.7 億美元，年成長 52%，這得益於學術界和社區領域廣泛的處方。我們堅信 BLINCYTO 是費城染色體陰性 B 細胞 ALL 成人和兒童患者的標準治療方法。

Our U.S. launch of IMDELLTRA for the treatment of patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy continues its strong momentum, generating $81 million in sales in the first quarter. To date, IMDELLTRA has been administered in patients in academic cancer centers, regional cancer hospitals and community oncology clinics, indicating broad adoption and comfort with this important new cancer therapy.

我們在美國推出的用於治療化療期間或化療後病情進展的廣泛期小細胞肺癌患者的 IMDELLTRA 繼續保持強勁勢頭，第一季的銷售額達到 8,100 萬美元。迄今為止，IMDELLTRA 已在學術癌症中心、區域癌症醫院和社區腫瘤診所的患者中使用，表明這種重要的新型癌症療法得到了廣泛的採用和認可。

In April, we expanded our global reach with the launch of IMDELLTRA in Japan, marking an important step forward in our commitment to bringing innovative oncology therapies to patients around the world. Momentum behind IMDELLTRA is being reinforced by compelling new data. We recently announced new clinical data demonstrating that IMDELLTRA met the primary endpoint of superior overall survival in small cell lung cancer compared to standard of care chemotherapy. This is a meaningful confirmation of IMDELLTRA's efficacy for patients facing one of the most aggressive and difficult-to-treat cancers. And our field teams are acting with urgency and their educational efforts with the medical community.

今年 4 月，我們在日本推出 IMDELLTRA，擴大了全球影響力，這標誌著我們致力於為全球患者提供創新腫瘤療法的承諾邁出了重要一步。令人信服的新數據增強了 IMDELLTRA 背後的動力。我們最近公佈了新的臨床數據，證明 IMDELLTRA 與標準化療相比，達到了小細胞肺癌整體存活率更高的主要終點。這對於 IMDELLTRA 治療最具侵襲性和最難治療的癌症之一的患者俱有重要的療效。我們的實地團隊正在緊急行動，並向醫學界進行教育工作。

Biosimilar portfolio sales were $735 million in the first quarter, representing an increase of 35% year over year. Sales of PAVBLU, the biosimilar to EYLEA, reached $99 million in the first quarter. Retina Specialists are responding very positively to PAVBLU, expressing appreciation for this high-quality Amgen biosimilar delivered in an easy-to-use prefilled syringe.

第一季生物相似藥產品組合銷售額為 7.35 億美元，年增 35%。EYLEA 的生物相似藥 PAVBLU 的第一季銷售額達到了 9,900 萬美元。視網膜專家對 PAVBLU 的反應非常積極，並對這種透過易於使用的預充式註射器輸送的高品質安進生物仿製藥表示讚賞。

Importantly, on April 1, PAVBLU received its permanent reimbursement Q code, which will facilitate easier access for patients. We're also pleased with the successful US launches of WEZLANA, a biosimilar to STELARA, and BKEMV, a biosimilar to SOLIRIS. Both launches have been received well by our patient and prescriber communities. We expect these recent launches will further enhance the robust growth and attractive returns from our biosimilar portfolio.

重要的是，4 月 1 日，PAVBLU 收到了永久報銷 Q 代碼，這將方便患者更輕鬆地獲得報銷。我們也很高興看到 STELARA 的生物相似藥 WEZLANA 和 SOLIRIS 的生物相似藥 BKEMV 在美國成功上市。兩次發布都受到了患者和處方者群體的一致好評。我們預計這些近期推出的產品將進一步增強我們的生物相似藥產品組合的強勁成長和可觀的回報。

2025 is off to a strong start with double-digit growth across our broad and deep portfolio. Looking ahead, we see significant growth potential powered by disciplined execution, a high-performing team and above all, a clear and unwavering commitment to the patients we serve.

2025 年開局強勁，我們廣泛而深入的投資組合均實現了兩位數的成長。展望未來，我們看到了巨大的成長潛力，這得益於嚴謹的執行力、高效的團隊以及最重要的，對我們所服務的患者明確而堅定的承諾。

I'll now hand it over to Jay.

現在我將把它交給傑伊。

Thank you, Murdo, and good afternoon, everyone. The first quarter has been exceptionally productive for R&D, extending our track record of high-quality on-time execution and highlighted by significant clinical and regulatory achievements. Most notably, we received FDA approval for UPLIZNA in IgG4-related disease, the second approval in a series of B cell-mediated diseases we are studying with this medicine. We also announced positive data from Phase 3 studies of Rocatinlimab, UPLIZNA and IMDELLTRA, while initiating multiple Phase 3 trials of MariTide and TEZSPIRE.

謝謝你，Murdo，大家下午好。第一季的研發成果異常豐碩，延續了我們高品質、準時執行的記錄，並在臨床和監管方面取得了重大成就。最值得注意的是，我們獲得了 FDA 批准 UPLIZNA 用於治療 IgG4 相關疾病，這是我們使用該藥物研究的一系列 B 細胞介導疾病中的第二次批准。我們也公佈了 Rocatinlimab、UPLIZNA 和 IMDELLTRA 3 期研究的積極數據，同時啟動了 MariTide 和 TEZSPIRE 的多個 3 期試驗。

Let's begin with MariTide, our investigational therapy for obesity and obesity-related conditions that features a unique and differentiated profile. In March, we initiated 2 Phase 3 studies in chronic wave management as part of our comprehensive MARITIME Phase 3 program. These trials will evaluate MariTide in two distinct populations, adults living with obesity or overweight without type 2 diabetes and adults with obesity or overweight with type 2 diabetes. Both studies will assess the safety, efficacy and tolerability of three target dose levels of MariTide preceded by an optimized dose escalation regimen to improve the patient experience. The primary endpoint for each study is the change from baseline body weight at 72 weeks.

讓我們從 MariTide 開始吧，這是我們針對肥胖和肥胖相關疾病的研究療法，具有獨特和差異化的特徵。3 月份，我們啟動了兩項慢性波浪管理第 3 期研究，作為我們綜合 MARITIME 第 3 階段計劃的一部分。這些試驗將在兩個不同的人群中評估 MariTide，即患有肥胖或超重但未患 2 型糖尿病的成年人和患有肥胖或超重但患有 2 型糖尿病的成年人。兩項研究都將評估 MariTide 三種目標劑量等級的安全性、有效性和耐受性，並採用優化的劑量遞增方案來改善患者體驗。每項研究的主要終點是 72 週時體重相對於基線的變化。

Beyond these first two studies, we anticipate initiating additional MARITIME Phase 3 studies later this year, evaluating MariTide in specific obesity-related conditions. Last November, we presented top line results at 52 weeks from our Phase 2 chronic weight management study, which highlighted MariTide's monthly or less frequent dosing, consistent, predictable and sustained weight loss across all doses without a weight loss plateau through 52 weeks and MariTide's clinically meaningful impact on cardiometabolic parameters, including hemoglobin A1c.

除了這兩項研究之外，我們預計將在今年稍後啟動更多的 MARITIME 第三階段研究，評估 MariTide 在特定肥胖相關疾病中的作用。去年 11 月，我們公佈了第二階段慢性體重管理研究 52 週的頂線結果，該研究強調了 MariTide 每月或更少頻率的給藥，在所有劑量下持續、可預測和持續的減肥效果，並且在 52 週內沒有減肥平台期，以及 MariTide 對心臟代謝參數（包括糖化血紅蛋白 A1c）的臨床影響。

At the American Diabetes Association or ADA Annual Meeting this June, the underlying details from this Phase 2 study at 52 weeks will be presented. Clear from these data is the important finding that dose escalation which was studied in 2 of the treatment arms, meaningfully improved tolerability, in particular, rates of nausea and vomiting as compared with fixed dose administration, which was used in the other 7 treatment arms.

今年 6 月的美國糖尿病協會或 ADA 年會上將公佈這項為期 52 週的 2 期研究的基本細節。這些數據清楚地表明了一個重要的發現：與其他 7 個治療組採用的固定劑量給藥相比，在 2 個治療組研究的劑量遞增顯著提高了耐受性，特別是噁心和嘔吐的發生率。

This finding is consistent with the clinical experience to date with GLP-1-based therapies and was further supported by our Phase 1 pharmacokinetic study that tested even lower starting doses of MariTide. Details from this study will also be discussed at ADA. These learnings have informed the design of our 2 Phase 3 studies of MariTide for chronic weight management, which are open and enrolling robustly.

這項發現與迄今為止基於 GLP-1 的療法的臨床經驗一致，並得到了我們測試更低起始劑量 MariTide 的 1 期藥物動力學研究的進一步支持。該研究的細節也將在 ADA 上討論。這些經驗為我們針對慢性體重管理的 MariTide 的 2 個 3 期研究的設計提供了參考，這兩項研究目前已開放並正在積極招募受試者。

Looking ahead to the second half of 2025, we expect key data for MariTide, including both the ongoing Phase 2 type 2 diabetes study, which has completed enrollment as well as end of treatment period data from Part 2 of the ongoing Phase 2 chronic weight management study. MariTide represents a promising treatment advance for people living with obesity and related conditions, especially given its monthly or less frequent dosing, predictable and sustained weight loss and clinically meaningful impact on cardiometabolic parameters, we are committed to fully realizing its therapeutic potential.

展望 2025 年下半年，我們預期 MariTide 的關鍵數據包括正在進行的 2 期 2 型糖尿病研究（已完成招募）以及正在進行的 2 期慢性體重管理研究第 2 部分的治療期結束數據。MariTide 代表肥胖症及相關疾病患者的一種有希望的治療進步，特別是考慮到其每月或更少頻率的給藥、可預測和持續的體重減輕以及對心臟代謝參數的臨床影響，我們致力於充分發揮其治療潛力。

Beyond MariTide, in General Medicine, we look forward to data from the Repatha VESALIUS Phase 3 primary prevention study in the second half of this year. Given the profound and sustained benefit of Repatha in the secondary prevention setting, we're optimistic about these data and the potential opportunity to reach additional patients at high risk of a first cardiovascular event.

除了 MariTide，在一般醫學領域，我們期待今年下半年 Repatha VESALIUS 第 3 階段一級預防研究的數據。鑑於 Repatha 在二級預防環境中的深遠而持續的益處，我們對這些數據以及接觸更多首次心血管事件高風險患者的潛在機會感到樂觀。

Turning to Olpasiran, our promising best-in-class small interfering RNA medicine targeting Lp(a), we are bringing a precision medicine approach to cardiovascular risk reduction for the many patients with Lp(a) elevation. The fully enrolled OCEAN A Phase 3 cardiovascular outcomes trial of Olpasiran continues to progress.

談到 Olpasiran，這是我們很有前景的針對 Lp(a) 的一流小幹擾 RNA 藥物，我們正在為眾多 Lp(a) 升高的患者帶來精準醫療方法來降低心血管風險。Olpasiran 的完全入組 OCEAN A 第 3 期心血管結果試驗正在持續進展。

Moving on to our rare disease portfolio. We are very excited about UPLIZNA's expanding potential to improve the lives of those facing rare inflammatory conditions. In April, the FDA approved UPLIZNA as the first and only treatment for adults living with immunoglobulin G4-related disease, delivering durable disease control in this recently described chronic and debilitating immune-mediated inflammatory condition that often affects multiple organ systems.

接下來介紹我們的罕見疾病組合。我們對 UPLIZNA 在改善罕見發炎患者生活方面不斷擴大的潛力感到非常興奮。今年 4 月，FDA 批准 UPLIZNA 作為首個也是唯一一個針對患有免疫球蛋白 G4 相關疾病的成年人的治療方法，為這種最近描述的慢性和衰弱性免疫介導發炎疾病提供持久的疾病控制，這種疾病通常會影響多個器官系統。

UPLIZNA is an innovative biologic that targets CD19 positive B cells and addresses a core driver of IgG4-related disease, significantly reducing disease flares and dependence on harmful long-term steroid treatment. Additionally, we recently presented compelling 52-week data from our pivotal Phase 3 MINT study, evaluating UPLIZNA in patients with generalized myasthenia gravis. These results demonstrated durable and sustained efficacy of UPLIZNA in patients with acetylcholine receptor autoantibody positive generalized myasthenia gravis with only two doses a year following an initial loading dose.

UPLIZNA 是一種創新生物製劑，針對 CD19 陽性 B 細胞並解決 IgG4 相關疾病的核心驅動因素，顯著減少疾病發作和對有害的長期類固醇治療的依賴。此外，我們最近公佈了關鍵的 3 期 MINT 研究的令人信服的 52 週數據，該研究評估了 UPLIZNA 對全身性重症肌無力患者的療效。這些結果表明，對於乙醯膽鹼受體自體抗體陽性全身性重症肌無力患者，在初始負荷劑量後每年僅需服用兩次 UPLIZNA 即可獲得持久有效的療效。

The 52-week MINT results highlight UPLIZNA's promise as a new standard of care in generalized myasthenia gravis, offering durable and sustained symptom relief with a simplified treatment regimen while minimizing steroid use.

52 週的 MINT 結果凸顯了 UPLIZNA 作為全身性重症肌無力治療新標準的前景，它透過簡化的治療方案提供持久和持續的症狀緩解，同時最大限度地減少類固醇的使用。

Since the publication of these data, we have met with numerous opinion leaders who are also enthusiastic about UPLIZNA’s profile, highlighting the unique mechanism of action, patient-centered every six month dosing schedule and durable sustained efficacy. We are also pleased to announce that the FDA has accepted the regulatory submission of the UPLIZNA MINT Phase 3 generalized myasthenia gravis data with a PDUFA date of December 14, 2025.

自從這些數據公佈以來，我們遇到了許多意見領袖，他們也對 UPLIZNA 的形象充滿熱情，強調了其獨特的作用機制、以患者為中心的每六個月一次的給藥計劃以及持久的持續療效。我們也很高興地宣布，FDA 已經接受了 UPLIZNA MINT 第 3 期全身性重症肌無力資料的監管提交，PDUFA 日期為 2025 年 12 月 14 日。

The recent FDA approval in IgG4-related disease and the strong clinical evidence in myasthenia gravis, underscore Amgen's ongoing leadership in developing innovative treatments targeting CD19 positive B cells in cancer, inflammation and in rare disease more generally, where only 5% of the estimated 10,000 rare diseases have available treatments.

FDA 最近批准了 IgG4 相關疾病的治療方案，並在重症肌無力方面提供了強有力的臨床證據，這凸顯了安進在開發針對癌症、炎症和罕見疾病的 CD19 陽性 B 細胞的創新療法方面的持續領導地位，而在這些罕見疾病中，估計有 10,000 種罕見疾病，但只有 5% 可以獲得治療方法。

In inflammation, we and our partner, AstraZeneca, have initiated 2 Phase 3 studies of TEZSPIRE in chronic obstructive pulmonary disease, targeting patients with moderate to very severe COPD with blood eosinophil counts greater than or equal to 150 cells per microliter.

在發炎方面，我們和我們的合作夥伴阿斯特捷利康已啟動 TEZSPIRE 在慢性阻塞性肺病中的兩項 3 期研究，針對血液嗜酸性粒細胞計數大於或等於每微升 150 個細胞的中度至重度 COPD 患者。

COPD is the world's third leading cause of death, and we're excited about the impact TEZSPIRE could have in this setting. Beyond COPD, we completed the regulatory submission of TEZSPIRE's Phase 3 data for chronic rhinosinusitis with nasal polyps and look forward to a PDUFA date of October 19, 2025.

COPD 是世界第三大死因，我們對 TEZSPIRE 在這方面可能產生的影響感到非常興奮。除了 COPD 之外，我們還完成了 TEZSPIRE 針對伴有鼻息肉的慢性鼻竇炎的 3 期數據的監管提交，並期待 PDUFA 日期為 2025 年 10 月 19 日。

In March, we announced data from three additional Phase 3 studies from the Rocatinlimab ROCKET program in atopic dermatitis, notably IGNITE, which met its primary and key secondary end points. We look forward to additional data from the ROCKET program in the second half of 2025.

3 月份，我們公佈了 Rocatinlimab ROCKET 計畫針對異位性皮膚炎的另外三項 3 期研究的數據，尤其是 IGNITE，該研究達到了其主要終點和關鍵次要終點。我們期待 2025 年下半年從 ROCKET 計畫獲得更多數據。

In oncology, we recently announced compelling results for IMDELLTRA from our DeLLphi-304 Phase 3 trial, where at a planned interim analysis, the study met its primary endpoint, demonstrating a significant and clinically meaningful overall survival benefit. DeLLphi-304 evaluated IMDELLTRA in patients with small cell lung cancer who progressed on or after initial platinum-based chemotherapy versus chemotherapy alone.

在腫瘤學領域，我們最近宣布了 DeLLphi-304 第 3 階段試驗中 IMDELLTRA 的令人信服的結果，在計劃的中期分析中，該研究達到了其主要終點，顯示出顯著且具有臨床意義的總體生存益處。DeLLphi-304 評估了 IMDELLTRA 對初始鉑類化療期間或之後病情進展的小細胞肺癌患者與單純化療的效果。

These randomized data are the first to show a substantial survival improvement head-to-head against standard of care chemotherapy, offering new hope for patients with this difficult disease. Together with the remarkable DeLLphi-301 data already reported, IMDELLTRA has the potential to become the new standard of care for second-line small cell lung cancer. As an oncologist, I'm really encouraged by IMDELLTRA as a new and highly efficacious therapy for an aggressive and common solid tumor for which there has been very little progress.

這些隨機數據首次顯示出與標準化療相比存活率有顯著提高，為患有這種難治疾病的患者帶來了新的希望。結合已經報告的顯著的 DeLLphi-301 數據，IMDELLTRA 有可能成為二線小細胞肺癌治療的新標準。身為腫瘤學家，我對 IMDELLTRA 感到非常鼓舞，因為它是一種針對一種侵襲性常見實體瘤的新型高效療法，但這種療法目前進展甚微。

We look forward to sharing more detailed results at the upcoming ASCO meeting in early June. In addition to DeLLphi-304, we continue to investigate IMDELLTRA in earlier lines of small cell lung cancer. Currently, 2 Phase 3 studies are underway, and we are pleased to announce plans to initiate DeLLphi-312, a Phase 3 trial evaluating IMDELLTRA as induction and maintenance therapy in first-line treatment of extensive stage small cell lung cancer, here in combination with carboplatin, etoposide and durvalumab. We also continue to investigate our CD19 directed BiTE medicine BLINCYTO in earlier treatment settings, while also advancing a subcutaneous formulation of blinatumomab.

我們期待在 6 月初即將召開的 ASCO 會議上分享更詳細的結果。除了 DeLLphi-304 之外，我們也持續研究 IMDELLTRA 在早期小細胞肺癌中的作用。目前，兩項 3 期研究正在進行中，我們很高興地宣布計劃啟動 DeLLphi-312，這是一項 3 期試驗，評估 IMDELLTRA 作為廣泛期小細胞肺癌一線治療的誘導和維持療法，聯合卡鉑、依托泊苷和度伐利尤單抗。我們也將持續研究針對 CD19 的 BiTE 藥物 BLINCYTO 在早期治療環境中的應用，同時推進 blinatumomab 的皮下製劑。

In April, the FDA granted Breakthrough Therapy designation for subcutaneous blinatumomabin the treatment of adults with relapsed/refractory CD19-positive B-cell precursor acute lymphoblastic leukemia. Based on our experience to date, subcutaneous blinatumomabhas the potential to improve both the patient experience and efficacy. Our first-in-class STEAP1 CD3 bispecific T cell engager xaluritamig, is advancing in Phase 3 clinical development, where we are rapidly enrolling patients with metastatic castrate-resistant prostate cancer who will progress following taxane-based therapy. We are also exploring xaluritamig in combination therapy and in earlier stages of prostate cancer with multiple Phase Ib studies ongoing.

今年 4 月，FDA 授予皮下注射 blinatumomabin 突破性療法認定，用於治療復發/難治性 CD19 陽性 B 細胞前驅急性淋巴性白血病成年患者。根據我們迄今為止的經驗，皮下注射 blinatumomab 有可能改善患者的體驗和療效。我們的首創 STEAP1 CD3 雙特異性 T 細胞接合劑 xaluritamig 正在進入 3 期臨床開發階段，我們正在快速招募轉移性去勢抵抗性前列腺癌患者，這些患者在接受紫杉烷類藥物治療後病情將出現進展。我們也正在探索 xaluritamig 在合併治療和前列腺癌早期階段的應用，目前正在進行多項 Ib 期研究。

Collectively, IMDELLTRA, BLINCYTO and xaluritamig exemplified the significant growth potential of our robust bispecific T cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide. Beyond our T cell engagers, our first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody bemarituzumab is advancing the frontline gastric cancer therapy.

總的來說，IMDELLTRA、BLINCYTO 和 xaluritamig 體現了我們強大的雙特異性 T 細胞接合平台的巨大成長潛力，並加強了我們為全球癌症患者提供突破性治療的承諾。除了我們的 T 細胞接合劑之外，我們一流的成纖維細胞生長因子受體 IIb 定向單株抗體 bemarituzumab 正在推動一線胃癌治療的發展。

We expect data this quarter from FORTITUDE 101, a Phase 3 study of bemarituzumab combined with mFOLFOX6 chemotherapy versus chemotherapy alone. In the second half of 2025, we expect data from FORTITUDE-102, the Phase 3 study of bemarituzumabcombined with chemotherapy and nivolumab versus chemotherapy nivolumab alone. On biosimilars, we are rapidly advancing 3 Phase 3 programs, evaluating our biosimilars to OPDIVO, KEYTRUDA and OCREVUS as the next wave of Amgen biosimilar products.

我們預計本季將獲得 FORTITUDE 101 的數據，這是一項關於 bemarituzumab 合併 mFOLFOX6 化療與單獨化療對比的 3 期研究。我們預計在 2025 年下半年獲得 FORTITUDE-102 的數據，該研究是 bemarituzumab 聯合化療和 nivolumab 與單獨使用化療 nivolumab 的 3 期研究。在生物相似藥方面，我們正在快速推進3個3期項目，評估我們的生物相似藥與OPDIVO、KEYTRUDA和OCREVUS的對比，將其作為安進下一波生物仿製藥產品。

In closing, I want to thank my Amgen colleagues for delivering on a number of important milestones so far this year and for their relentless focus on the patients we serve.

最後，我要感謝我的安進同事們今年迄今為止所取得的許多重要里程碑，以及他們對我們服務的病人不懈的關注。

I'll now turn it over to Peter.

現在我將把發言權交給彼得。

Thank you, Jay. We're pleased with our strong first quarter performance and are on track with our 2025 full year goals and long-term objectives. The financial results are shown on slides 29 to 30 of the slide deck. In the first quarter, we delivered revenues of $8.1 billion, a 9% increase year over year. This reflects double-digit sales growth of 11%, driven by 14% volume growth from key brands, including Repatha, BLINCYTO, TEZSPIRE and EVENITY, partially offset by 6% lower net selling price. Our non-GAAP operating expenses rose 4% and led by non-GAAP R&D growth of 12% year over year, reflecting continued investment in our late-stage pipeline, including MariTide, olpasiran and rare disease.

謝謝你，傑伊。我們對第一季的強勁表現感到滿意，並且正在按計劃實現 2025 年全年目標和長期目標。財務結果顯示在投影片的第 29 至 30 張。第一季度，我們的營收為 81 億美元，年增 9%。這反映了 11% 的兩位數銷售額成長，主要得益於 Repatha、BLINCYTO、TEZSPIRE 和 EVENITY 等主要品牌的銷量成長 14%，但淨售價下降 6% 部分抵消了這一成長。我們的非公認會計準則營運費用上漲了 4%，其中非公認會計準則研發費用年增 12%，反映了我們對後期研發線的持續投資，包括 MariTide、olpasiran 和罕見疾病。

Our Q1 non-GAAP operating margin was 45.7%. This is above the outlook we gave on the fourth quarter earnings call, in part due to the timing of R&D spend now expected primarily in the second quarter, including milestone payments and other investments.

我們第一季的非公認會計準則營業利益率為 45.7%。這高於我們在第四季度收益電話會議上給出的預期，部分原因是研發支出的時間預計主要在第二季度，包括里程碑付款和其他投資。

The Horizon integration has progressed well, and we expect to reach the previously announced $500 million in pre-tax cost synergies by the end of this year. Our non-GAAP OI&E was down $53 million year over year, driven by lower interest expense through retirement of debt, including $4.5 billion in 2024 and $2.9 billion in the first quarter of 2025. In addition, we repaid $1 billion today as we continue to progress the strengthening of our balance sheet.

Horizo​​n 整合進展順利，我們預計到今年年底將達到先前宣布的 5 億美元的稅前成本協同效應。我們的非公認會計準則營業收入和支出年減 5,300 萬美元，原因是透過償還債務降低了利息支出，其中 2024 年為 45 億美元，2025 年第一季為 29 億美元。此外，隨著我們繼續加強資產負債表，我們今天償還了 10 億美元。

Since the announcement of the Horizon acquisition, we have now retired $10.8 billion of debt. Our non-GAAP tax rate decreased 0.8 percentage-points year over year to 14.6% and primarily due to the change in earnings mix. The company generated $1.0 billion in free cash flow in the first quarter, reflecting continued investment in growth and operational momentum across the business. We spent $400 million in the first quarter on capital expenditures, driven by investments across our manufacturing sites, including Ohio, North Carolina and Puerto Rico.

自從宣布收購 Horizo​​​​n 以來，我們已償還了 108 億美元的債務。我們的非公認會計準則稅率年減 0.8 個百分點至 14.6%，主要是由於收益結構的變化。該公司第一季產生了 10 億美元的自由現金流，反映了對整個業務成長和營運勢頭的持續投資。我們第一季的資本支出為 4 億美元，主要來自我們在俄亥俄州、北卡羅來納州和波多黎各等製造基地的投資。

For 2025, we expect no change in our capital expenditures outlook of $2.3 billion, which will support our products across the portfolio and our innovative pipeline, including MariTide. Our commitment to innovation is also evident as we deploy artificial intelligence across the value chain, informing molecule design and discovery research, enabling faster trial enrollment and streamlining regulatory filings and clinical development and enhancing our responsiveness to customers in commercial operations. In addition, we returned capital to shareholders as we paid competitive dividends of $2.38 per share, representing a 6% increase compared to the first quarter of 2024.

到 2025 年，我們預計資本支出前景將保持不變，為 23 億美元，這將支持我們整個產品組合的產品和創新產品線，包括 MariTide。我們對創新的承諾也顯而易見，因為我們在整個價值鏈中部署人工智慧，為分子設計和發現研究提供信息，加快試驗登記速度，簡化監管備案和臨床開發，並增強我們對商業運營中客戶的響應能力。此外，我們還向股東返還了資本，支付了每股 2.38 美元的有競爭力的股息，與 2024 年第一季相比增長了 6%。

Let's turn to the outlook for the business for 2025 on slide 31. We are reaffirming our 2025 total revenue guidance in the range of $34.3 billion to $35.7 billion and also reaffirming our non-GAAP earnings per share guidance between $20 and $21.20. This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future including potential sector-specific tariffs.

讓我們來看看第 31 張投影片上的 2025 年業務展望。我們重申 2025 年總收入預期在 343 億美元至 357 億美元之間，同時重申非 GAAP 每股收益預期在 20 美元至 21.20 美元之間。本指南包括已實施關稅的預期影響，但並未考慮未來可能實施的任何關稅，包括潛在的特定產業關稅。

In addition, let me highlight a few updates to our outlook for the remainder of the year. We now expect non-GAAP R&D expense to grow approximately 20% in 2025 versus growing mid-teens previously, reflecting increased investments to advance key late-stage pipeline assets, including MariTide and olpasiran. We now anticipate non-GAAP OI&E to be approximately $2.3 billion in 2025. We now expect a non-GAAP tax rate of 14.5% to 16.0%. And for WEZLANA in the United States, we now expect quarterly sales to fluctuate and do not expect any sales in the second quarter following a large sales ordered in the first quarter.

此外，讓我重點介紹一下我們對今年剩餘時間的展望的一些更新。我們現在預計，2025 年非 GAAP 研發費用將成長約 20%，而先前的成長率為 15% 左右，這反映出對推進關鍵後期管線資產（包括 MariTide 和 olpasiran）的投資增加。我們現在預計 2025 年非 GAAP OI&E 將達到約 23 億美元。我們現在預計非公認會計準則稅率為 14.5% 至 16.0%。對於美國的 WEZLANA，我們現在預計季度銷售額將出現波動，並且在第一季訂單量較大之後，預計第二季不會有任何銷售額。

And let me remind you of prior items that have not changed to our outlook for the remainder of the year. For the full year, we continue to expect Other Revenue to be approximately $1.4 billion. We continue to project that full year non-GAAP operating margin as a percentage of product sales to be roughly 46%. We expect share repurchases not to exceed $500 million in 2025. We continue to expect 2025 free cash flow performance to be roughly comparable to 2023.

讓我提醒大家，先前提到的事項並沒有改變我們對今年剩餘時間的展望。就全年而言，我們繼續預計其他收入約為 14 億美元。我們繼續預測全年非 GAAP 營業利潤率佔產品銷售額的百分比約為 46%。我們預計 2025 年股票回購額不會超過 5 億美元。我們仍預期 2025 年自由現金流表現將與 2023 年大致相當。

As mentioned on our fourth quarter earnings call, this decline is primarily driven by 2024 working capital favorability and the incremental capital expenditures. Free cash flow in the second quarter will be impacted by the shift in 2024 tax payments to Q2 2025 and the final $1.8 billion repatriation tax payment. I know there's a lot of interest in taxes and tariffs. We understand the impetus for increasing US investment in manufacturing.

正如我們在第四季度收益電話會議上提到的那樣，這種下降主要是由於 2024 年營運資本有利因素和增量資本支出所致。第二季的自由現金流將受到 2024 年稅款支付轉移到 2025 年第二季以及最終 18 億美元遣返稅款的影響。我知道人們對稅收和關稅很感興趣。我們理解美國增加製造業投資的動力。

Amgen has a robust manufacturing presence in the United States, including Puerto Rico. And of course, has invested for decades in the United States-based research and development. To build on the manufacturing base in the US, we agree with our peers, but the most effective answer is not tariffs but tax policy. In fact, for Amgen and others, investment in manufacturing has significantly increased since President Trump's 2017 Tax Cuts and Jobs Act.

安進在包括波多黎各在內的美國擁有強大的製造業務。當然，該公司幾十年來一直在美國進行研發投資。為了鞏固美國製造業基礎，我們同意同行的觀點，但最有效的答案不是關稅，而是稅收政策。事實上，自川普總統推出 2017 年減稅與就業法案以來，安進等公司對製造業的投資已大幅增加。

In part, based on the expectation of continued pro-growth tax policy, we recently announced among other investments in the United States that we are more than doubling down on our investments in manufacturing capacity in North Carolina and Ohio. We are focused on delivering sustained long-term value for patients and shareholders by doing what we said we would do growing leadership in the United States and internationally, driving innovation in areas of high unmet medical need and maintaining rigorous financial discipline. We continue to focus on execution excellence across the enterprise and remain well positioned for sustained growth through the long term.

部分原因在於，基於對持續促進成長的稅收政策的預期，我們最近宣布，除在美國進行其他投資外，我們還將把對北卡羅來納州和俄亥俄州製造產能的投資增加一倍以上。我們致力於透過履行承諾，為患者和股東提供持續的長期價值，在美國和國際上不斷提升領導地位，推動醫療需求高度未滿足領域的創新，並保持嚴格的財務紀律。我們將繼續關注整個企業的卓越執行，並為長期持續成長做好準備。

I'm grateful to work with all of our colleagues worldwide in serving patients. This concludes our financial update. I'll hand it back to Bob for our Q&A session.

我很高興能與世界各地的同事一起為患者服務。我們的財務更新到此結束。我會將其交還給鮑勃，以供我們進行問答。

You remind our callers please of the procedure for asking questions.

請您提醒我們的來電者提問的程序。

(Operator Instructions)

（操作員指示）

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

Congrats on all the progress. I was just wondering, Jay, if you could help frame for us what we should be looking for at ADA with respect to MariTide. I know it's going to be the first detailed presentation of the Phase 2 data. But what do you think kind of the key message and key learnings coming out from that will be? And then the kind of related question is I know there's a lot of focus on the potential CVOT trial that you guys are likely plan to conduct with MariTide in the design. So just wondering if you could comment at all on the potential control arm there.

祝賀你取得的所有進展。傑伊，我只是想知道，你是否可以幫我們規劃一下，關於 MariTide，我們應該在 ADA 上尋找什麼。我知道這將是第二階段數據的首次詳細展示。但是您認為從中得到的關鍵資訊和關鍵經驗是什麼呢？然後相關的問題是，我知道大家非常關注你們可能計劃與 MariTide 一起設計進行的潛在 CVOT 試驗。所以我只是想知道您是否可以對那裡的潛在控制臂發表評論。

Yeah. Thanks, Terence, for the question. Really looking forward to the ADA. We've already shared the salient data from the Phase 2 chronic weight management study, weight loss and excellent tolerability at 52 weeks. So what we call Part 1 on that trial as well as data from a dedicated Phase 1 pharmacokinetic study. And the key insights remain unchanged, strong efficacy, no plateau to 52 weeks, monthly MariTide, very well tolerated at the target dose that the dose escalation works and comes without any compromise to weight loss, also strong activity on cardiometabolic parameters, including A1c.

是的。謝謝 Terence 提出的問題。真的很期待 ADA。我們已經分享了第二階段慢性體重管理研究的顯著數據，即 52 週時的體重減輕和優異的耐受性。因此，我們稱之為本試驗的第 1 部分以及專門的第 1 期藥物動力學研究的數據。關鍵見解維持不變，療效強勁，52 週內無平台期，每月使用 MariTide，目標劑量耐受性極佳，劑量遞增有效且不會對減肥產生任何影響，對心臟代謝參數（包括 A1c）也有很強的活性。

So the ADA will focus on these insights as well as some underlying details of the 2 trials. It will feature some new mechanistic data, including some recently published data in Nature Metabolism that serves to really validate the mechanism of action, the dual mechanism of action of MariTide. We're looking forward to sharing these details at ADA, hearing from the presenters who are true leaders in the field. And following the session, we intend to have an IR call after the event to take questions reflect on the results through 52 weeks.

因此，ADA 將重點關注這些見解以及這兩項試驗的一些基本細節。它將包含一些新的機制數據，包括《自然代謝》雜誌最近發表的一些數據，這些數據有助於真正驗證作用機制，即 MariTide 的雙重作用機制。我們期待在 ADA 上分享這些細節，並聽取該領域真正的領導者的演講者的演講。會議結束後，我們打算召開 IR 電話會議，回答有關 52 週結果的問題。

But here at Amgen, we're on to Phase 3. Oh, yes. And on the CVOT study, we won't share any details today regarding the CVOT study. But with our 2 Phase 3 chronic weight management programs now open and enrolling, enrolling well. We are working to initiate a broad Phase 3 program that includes ASCVD, heart failure studies, chronic kidney disease, obstructive sleep apnea and other indications of interest, and we'll have more to share in the fullness of time about the details of these trials.

但在安進，我們已進入第三階段。哦是的。關於 CVOT 研究，我們今天不會分享有關 CVOT 研究的任何細節。但是，我們的第 2 階段第 3 慢性體重管理計劃現已開放並開始招生，招生情況良好。我們正在努力啟動一項廣泛的 3 期計劃，其中包括 ASCVD、心臟衰竭研究、慢性腎臟病、阻塞性睡眠呼吸中止症和其他感興趣的適應症，我們將在適當的時候分享更多有關這些試驗的細節。

Okay. Thanks, Julien. Let's go to the next caller.

好的。謝謝，朱利安。我們接聽下一位來電者。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

With regard to UPLIZNA in IgG4 as given the recent approval as well as myasthenia gravis, could you just help us understand the commercial strategy, including the relevant prescribers and patient identification efforts for the former?

關於最近獲得批准的 IgG4 和重症肌無力治療藥物 UPLIZNA，您能否幫助我們了解其商業策略，包括前者的相關處方者和患者識別工作？

Yeah. Salveen, it's Murdo. Thanks for the question on UPLIZNA. We're obviously quite excited about the opportunity to be the first approved therapy for IgG4. It's a condition that is primarily diagnosed and I should say recently, there's been the evolution of a diagnostic code, which really only was introduced in October 2023. So it's been a relative recent phenomenon to actually have formal diagnostic criteria in a code for this disease.

是的。薩爾文，我是默多。感謝您對 UPLIZNA 提出的問題。我們顯然對成為首個獲準的 IgG4 療法感到非常興奮。這是一種主要透過診斷獲得的疾病，最近，診斷代碼已經發生了變化，而該代碼實際上是在 2023 年 10 月才推出的。因此，實際上在代碼中為這種疾病制定正式的診斷標準是一種相對較新的現象。

But primarily diagnosed and managed by rheumatologists, You do see on occasion gastroenterologists, sometimes neurologists, just given the way in which the disease might manifest in the organ involvement. Obviously, because of Amgen's very long history in dealing with inflammation and autoimmune diseases, we've got very good presence here with the key customer types and key prescribers.

但主要由風濕病學家進行診斷和治療，您偶爾也會見到胃腸病學家，有時也見到神經病學家，只是考慮到疾病可能在器官受累方面表現出來的方式。顯然，由於安進在治療發炎和自體免疫疾病方面有著悠久的歷史，我們在關鍵客戶類型和關鍵處方者中擁有非常好的地位。

We have had a field force deployed for several months now profiling and engaging with the relevant physician community. So we're hitting the ground running, so to speak, with the approval. The epidemiology here is roughly 20,000 patients in the US and we're excited to have that impact. This is a horrible disease. People really do not fare well when this flares and UPLIZNA a highly effective product as part of the clinical data generated thus far.

我們已經派遣了一支實地隊伍幾個月來對相關醫生群體進行分析和接觸。因此，可以說，在獲得批准後，我們就開始著手處理此事。這裡的流行病學數據表明，美國大約有 20,000 名患者，我們很高興能夠產生這樣的影響。這是一種可怕的疾病。當這種情況爆發時，人們確實不會表現得很好，而根據迄今為止產生的臨床數據，UPLIZNA 是一種非常有效的產品。

And then on gMG, we're really thrilled with the opportunity to go into a competitive category with a very different mechanism than the drugs that are available today. Again, this is a therapeutic area where we have an installed presence with the key prescribing community. So optimistic that when we secure approval for this indication that we'll be thrilled. I don't know, Jay, would you want to add anything on gMG?

對於 gMG，我們非常高興有機會進入一個與現有藥物機制截然不同的競爭類別。再次強調，這是一個治療領域，我們在主要處方社區中已經建立了合作關係。我們非常樂觀，當我們獲得該適應症的批准時，我們會非常興奮。我不知道，傑伊，你想在 gMG 上添加一些內容嗎？

Yeah. I mean reflecting also on IgG4, we think a lot about how will this fit into the standard of care in both diseases. And IgG4-related disease has no standard of care. These are patients with chronic inflammatory painful protein symptoms, recurrent flares and we saw an 87% reduction in disease-specific flare activity. And so this hopefully becomes a powerful new standard of care.

是的。我的意思是，考慮到 IgG4，我們花了很多時間思考它如何適應這兩種疾病的照護標準。且 IgG4 相關疾病沒有治療標準。這些患者患有慢性發炎性疼痛蛋白質症狀，反覆發作，我們發現疾病特異性發作活動減少了 87%。因此，希望這能成為一種強而有力的新護理標準。

And then in GMG, this medicine stacks up really well to what physicians and patients have access to today. We had a chance to share back in April, and it was also simultaneously published in New England Journal, the really strong data from the Phase 3 MINT trial. And we put up just outstanding efficacy data against the myasthenia gravis activity of daily living score we showed activity in both important subpopulations of patients, acetylcholine receptor positive and must positive. And -- this medicine is -- provides a durable benefit to patients.

然後在 GMG，這種藥物與當今醫生和患者可以獲得的藥物相比確實非常好。我們在四月有機會分享第三階段 MINT 試驗的真正強勁數據，而且它也同時在《新英格蘭雜誌》上發表。我們針對重症肌無力日常生活活動評分提供了出色的療效數據，顯示該療法在乙醯膽鹼受體陽性和乙醯膽鹼受體陽性這兩個重要的患者亞群中均有療效。而這種藥物能為患者帶來持久的益處。

It's given every six months. I think which really suits the lifestyle of people who will then feel hopefully very healthy. and it's quite convenient for them to receive. But most importantly, it targets the core biology. This is a disease caused by pathologic auto antibodies. And here, we are targeting the cell that elaborate those antibodies. So we feel very hopeful that UPLIZNA will be an important new standard of care in generalized myasthenia gravis.

每六個月發放一次。我認為這確實適合人們的生活方式，希望人們會感覺非常健康。而且接收起來也比較方便。但最重要的是，它針對的是核心生物學。這是一種由病理性自體抗體引起的疾病。在這裡，我們的目標是產生這些抗體的細胞。因此，我們非常希望 UPLIZNA 能成為治療全身性重症肌無力的重要新標準。

Michael Yee, Jefferies.

麥可‧餘 (Michael Yee)，傑富瑞集團 (Jefferies)。

Maybe for Jay, I often hear about two narratives on the obesity program. One is the tolerability remains high. And I know you've gone to a lower titration. So I'm curious about your confidence that we will see very competitive tolerability and very strong efficacy and that, that narrative will hold up? And secondly, that there's a competitor out there who’s now put up oral data, which apparently is going to have a huge market share. And so you don't have an oral. Maybe you could respond to either of those and how you're going to be competitive against these developments that have played out.

也許對傑伊來說，我經常聽到關於肥胖計畫的兩種敘述。一是耐受性仍然較高。我知道你已經降低滴定度了。所以我很好奇，您是否有信心我們會看到非常具有競爭力的耐受性和非常強大的功效，而且這種說法會成立？其次，現在有競爭對手提供口腔數據，這顯然將佔據巨大的市場份額。所以你沒有口語。也許您可以對其中任何一個做出回應，並說明您將如何應對已經發生的這些發展。

Yeah, Mike. Why don't I start on tolerability and then Murdo ask you if you wouldn't mind to weigh in on the development of oral medicines and their importance. Mike, we feel very confident -- I feel very confident about the tolerability and efficacy that we stand to observe in the Phase 3 clinical study, it is very well informed. By the strong efficacy that we saw in Phase 2 Part 1, the 52-week data, where we observed across the range of doses, significant benefit to patients with measurable weight loss as high as 20%.

是的，麥克。我先從耐受性開始，然後 Murdo 再問您是否願意權衡口服藥物的發展及其重要性。麥克，我們非常有信心——我對我們在第三階段臨床研究中觀察到的耐受性和有效性非常有信心，它非常有說服力。根據我們在第 2 階段第 1 部分中看到的強大療效，我們觀察到 52 週的數據，在各種劑量範圍內，患者都獲得了顯著的益處，體重減輕高達 20%。

The tolerability we learned, as have others in the field that GLP-1-based mechanisms of action benefit from dose escalation, benefit from lower starting doses, we confirmed these insights in a dedicated Phase 1 pharmacokinetic study, and we've taken the directionality of those 2 trials into the design of Phase 3, which when we can share this with you, will surely underscore that the design is constructed to deliver competitive, both efficacy and tolerability in patients with and without type 2 diabetes. Murdo about oral?

我們了解到耐受性，正如該領域的其他人一樣，基於 GLP-1 的作用機制受益於劑量遞增，受益於較低的起始劑量，我們在專門的 1 期藥代動力學研究中證實了這些見解，並且我們已將這 2 個試驗的方向性納入 3 期設計中，當我們能夠與您分享這一點時，必將強調該設計具有耐受性的糖尿病和耐受性。Murdo 關於口說？

Yeah. Thanks, Mike. We have obviously accounted for a segment of the market to be an oral market. We do anticipate, given the size of the obesity category, a relevant opportunity for orals to come in. Thus far, of course, we haven't seen necessarily the same degree of weight loss being achievable with orals as we've seen with MariTide.

是的。謝謝，麥克。我們顯然已經將一部分市場視為口頭市場。考慮到肥胖類別的規模，我們確實預期口服藥物將有一個相關的應用機會。當然，到目前為止，我們還沒有看到口服藥物能夠達到與 MariTide 相同程度的減肥效果。

And of course, MariTide really, given its monthly or even less frequent dosing, we think will be less vulnerable to orals, which are certainly going to come in and displace some of the weekly GLP-1s that are incumbent in the market today. I would also just say that we are pursuing other products in our early pipeline that are both large molecule, small molecule, oral and self-administered, incretin and non-incretin. So we really are looking at oral and non-oral mechanisms ourselves.

當然，考慮到 MariTide 每月或更低頻率的給藥，我們認為它不太容易受到口服藥物的影響，口服藥物肯定會取代目前市場上的一些每週服用一次的 GLP-1 藥物。我還想說，我們正在早期研發其他產品，包括大分子、小分子、口服和自我給藥、腸促胰島素和非腸促胰島素。所以我們確實在研究口頭和非口頭機制。

Trung Huynh, UBS.

Trung Huynh，瑞銀。

Great. Just on Repatha, which has been doing well for a number of quarters now. In our recent doc checks, some have pointed to an increasing preference for Novartis' Leqvio because of the buy-and-build program for that drug. Do you see increasing commercial competition from Leqvio in general? And going forward, there is going to be some late-stage data oral PCSK9 this year. What's your thoughts about the entry of those products?

偉大的。就 Repatha 而言，該品牌已連續多個季度表現良好。在我們最近的文檔檢查中，一些人指出，由於諾華公司針對該藥物的收購和建設計劃，人們對該藥物的偏好日益增加。您是否認為來自 Leqvio 的商業競爭總體上會加劇？展望未來，今年將會有一些口服 PCSK9 的後期數據。您對這些產品的進入有何看法？

Yeah. Thanks for the question, and thanks for noticing the growth in Repatha and the trajectory that we're on. The short answer to your question is yes, there's competition in the market. And yes, Leqvio definitely treating patients both in the U.S. and in some other markets around the world. I would say though that we still believe we have the best profile in the PCSK9 category given the ability to profoundly lower LDL cholesterol, the fact that we've generated cardiovascular event reduction. We have ongoing additional clinical trials to further expand the understanding of how Repatha when added to conventional therapy, can actually further reduce cardiovascular risk in a primary prevention, high-risk population.

是的。感謝您的提問，也感謝您注意到 Repatha 的成長和我們所處的發展軌跡。對你的問題的簡短答案是肯定的，市場上有競爭。是的，Leqvio 確實在美國和世界其他一些市場為患者提供治療。不過我想說的是，我們仍然相信，鑑於我們能夠大幅降低 LDL 膽固醇，並且能夠減少心血管事件，我們在 PCSK9 類別中擁有最佳表現。我們正在進行額外的臨床試驗，以進一步加深對 Repatha 與常規療法相結合後如何進一步降低一級預防高風險族群的心血管風險的理解。

So we do think that there's -- the class here is so underpenetrated in terms of the millions -- tens of millions, quite frankly, of patients who are at risk that really, there is room for competition and the fact that we have the momentum that we have, despite the growth of some of the other products in the category, should tell you that we continue to find ways to help new patients received the Repatha therapy that they should.

因此，我們確實認為，就數百萬——坦率地說，數千萬處於危險中的患者而言，這一類別的滲透率非常低，確實存在競爭空間，而且儘管該類別中的一些其他產品有所增長，但我們仍保持著良好的發展勢頭，這應該表明，我們將繼續尋找方法幫助新患者接受他們應該接受的 Repatha 治療。

The last piece of this, of course, is we have done a lot of work as Amgen to open up access and affordability for patients. And so we now have the commercial insured patients in the US, 50% which have no prior authorization requirement to receive approval for their therapy. So they're really the barriers that once were there in obtaining Repatha have largely dissipated. So we're growing nicely. We continue to promote the primary care. We've invested in direct-to-consumer advertising now, and we expect a strong growth trajectory to come.

當然，最後一點是，作為安進公司，我們做了很多工作來為患者提供可及性和可負擔性的藥物。因此，現在美國有 50% 的商業保險患者無需事先授權即可獲得治療批准。因此，獲取 Repatha 所面臨的障礙實際上已基本消失。所以，我們發展得很好。我們繼續推動初級保健。我們現在已經投資了直接面向消費者的廣告，我們預計未來將出現強勁的成長軌跡。

Evan Seigerman, BMO Capital Markets.

艾文‧塞格曼 (Evan Seigerman)，蒙特婁銀行資本市場。

So with the Q code in place, can you help us think about the near-term uptake of PAVBLU in the field? And are you seeing any pronounced shift to the biosimilar following the defunding at the patient's assistance charities?

那麼，有了 Q 程式碼，您能幫助我們思考一下 PAVBLU 在該領域的近期應用情況嗎？在病患援助慈善機構停止提供資金後，您是否看到向生物相似藥的明顯轉變？

Thanks for the question, Evan. We're obviously pleased with our biosimilar portfolio in general. We had a strong quarter there. PAVBLU has been well received by the retina specialist community. They like the high-quality biosimilar. They really like our prefilled syringe device that we launched. And we expect to continue to be able to help many patients and serve many patients with this product. We're working on contracting with a larger retina specialist groups and we'll have more to say as the year progresses. And then Amgen is happy to support patients through the charitable donations that we make to various agencies.

謝謝你的提問，埃文。總體而言，我們對我們的生物相似藥產品組合感到非常滿意。我們在該季度表現強勁。PAVBLU 受到了視網膜專家界的一致好評。他們喜歡高品質的生物相似藥。他們非常喜歡我們推出的預充式註射器裝置。而我們期望能夠持續透過該產品幫助眾多患者、服務眾多患者。我們正在與更大的視網膜專家團體簽約，隨著時間的推移，我們將會有更多消息要公佈。安進很高興透過向各個機構進行慈善捐贈來支持患者。

Chris Schott, JPMorgan.

摩根大通的克里斯·肖特。

Just a question on the incretin payer environment. I think we've seen some concern in the market today about more aggressive payer behavior with the CVS -- Wegovy announcement. I'm just interested and how you're thinking about these payer dynamics, potential new entrants in that space over time?

這只是關於腸促胰島素付款人環境的一個問題。我認為，今天我們看到市場對 CVS-Wegovy 公告中更激進的付款人行為有些擔憂。我只是感興趣，您如何看待這些付款人動態，以及隨著時間的推移該領域的潛在新進入者？

Yeah. Thanks for the question, Chris. Look, our focus in any payer environment, and it will be with the obesity categories to help make our products as available as possible to a large segment of the population. I think we're still all understanding what happened with the recent decision I believe you'll be referring to the CVS change that was announced. I do think, overall, PBMs and manufacturers alike are trying to make sure that more patients have access to reimbursement for obesity medicines. And we look forward to being able to do that when we enter the market.

是的。謝謝你的提問，克里斯。你看，在任何付款人環境中，我們的重點都是肥胖類別，以幫助我們的產品盡可能地為廣大民眾所用。我想我們仍然都了解最近的決定發生了什麼，我相信你會提到宣布的 CVS 變化。我確實認為，總體而言，PBM 和製造商都在努力確保更多患者能夠獲得肥胖藥物的報銷。我們期待進入市場後能夠做到這一點。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great. I have two interrelated questions about MariTide. Maybe just the first one, at ADA, is there a chance to get maybe even the 76-week data, from the obesity study from the Phase 2, including some of the less frequent dose in the Q2 and Q3 monthly dosing?

偉大的。我有兩個關於 MariTide 的相互關聯的問題。也許只是第一個，在 ADA，是否有機會從第 2 階段的肥胖研究中獲取甚至 76 週的數據，包括 Q2 和 Q3 每月給藥中的一些不太頻繁的劑量？

And then secondly, would you consider separately from doing a -- would you consider doing a switch study or patients switched from prior GLPs right into MariTide and doing less frequent dosing is an additional strategy to ultimately follow with?

其次，您是否會考慮單獨進行——您是否會考慮進行轉換研究，或者患者從先前的 GLP 直接轉換到 MariTide，並且減少給藥頻率是最終要遵循的額外策略？

Go ahead, Jay.

繼續吧，傑伊。

Yeah. Thanks, Yaron. First answer is no. The ADA presentation will focus on some mechanistic studies, some of the underlying details of Part 1, the first 52 weeks of the Phase 2 study as well as additional data from the Phase 1 pharmacokinetic study and reflections from these external key opinion leaders that we can't wait to hear ourselves. So no, I would not expect to see interim data from Part 2 which is ongoing, and we intend to share these data when we have them at the end of the year.

是的。謝謝，亞倫。第一個答案是否定的。ADA 的演示將重點放在一些機制研究、第 1 部分的一些基本細節、第 2 階段研究的前 52 週以及第 1 階段藥物動力學研究的附加數據，以及這些外部關鍵意見領袖的反思，我們迫不及待地想聽到這些反思。所以不，我不希望看到正在進行的第 2 部分的中期數據，我們打算在年底獲得這些數據時分享它們。

Your second question, welcome to the MariTide development team. It's great to have you thinking about next trials. And I take from your question that we agree actually that patients and physicians will want to know how can they start on MariTide if they're on another weight loss medicine that maybe is working, but is inconvenient or maybe isn't working well enough. And we do intend to generate data to support such a consideration. There'll be more to share on that in the future.

您的第二個問題，歡迎加​​入 MariTide 開發團隊。很高興您能考慮下一次試驗。從您的問題中我得知，我們實際上一致認為，如果患者和醫生正在服用其他可能有效但不方便或效果不夠好的減肥藥，他們想知道如何開始使用 MariTide。我們確實打算產生數據來支持這種考慮。未來將會有更多相關內容與大家分享。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

It's a question I've been thinking about for a while on the myasthenia gravis market dynamic. Specifically, a lot of times when some of the cross-trial comparisons have been made for UPLIZNA. They're often versus the MAX efficacy we see on FcRn. And we know FcRns have this waxing waning because as per label, you have to get off the drug.

這是我一段時間以來一直在思考的有關重症肌無力市場動態的問題。具體來說，很多時候針對 UPLIZNA 進行了一些交叉試驗比較。它們通常與我們在 FcRn 上看到的最大功效相反。我們知道 FcRns 有這種時強時弱的變化，因為根據標籤上的說明，你必須停藥。

So my point being, the true commercial price would actually be 2x for FcRns if you truly dose them through without the dosing holiday, which is apparently what a lot of clinicians are doing. So my question is, are payers aware of this dynamic? And what do you see as a realistic market share aspiration knowing that your competitor might potentially be 2x the price? Could you aim for like a 40% to 50% market share in MG?

所以我的觀點是，如果你真的在不暫停用藥的情況下給 FcRns 用藥，那麼它真正的商業價格實際上是 2 倍，而這顯然是許多臨床醫生正在做的事情。所以我的問題是，付款人是否意識到了這種動態？並且，當您知道競爭對手的價格可能是您的兩倍時，您認為現實的市佔率期望是多少？你能爭取 MG 40% 到 50% 的市佔率嗎？

Let's try and take this in two pieces, Umer. I think on the clinical piece, Jay, if you want to add any perspective. But on the market, obviously, Murdo, you can share our perspectives on the payer environment and so forth.

讓我們試著把這個問題分成兩個部分來看，烏默爾。傑伊，我想在臨床部分，如果你想添加任何觀點。但在市場上，顯然，Murdo，您可以分享我們對付款人環境等的看法。

Yeah. Thanks, Bob. Umer, thanks for the question. The GMG space will surely be shaped by the efficacy and the target product profile of the medicines available to treat the patients primarily. And -- and here, we think UPLIZNA has some really favorable considerations. It's very hard to do trial-by-trial comparisons, but suffice it to say that the significant observed efficacy by MG-ADL that we saw all the way out to week 52 and the durability of living in a randomized controlled trial environment through week 52 is indeed very strong, targeting the core biology, one might expect higher efficacy.

是的。謝謝，鮑伯。烏默爾，謝謝你的提問。GMG 領域必定會受到主要用於治療患者的藥物的功效和目標產品概況的影響。並且——在這裡，我們認為 UPLIZNA 有一些非常有利的考慮。進行逐次試驗的比較非常困難，但可以說，我們一直到第 52 週看到的 MG-ADL 的顯著療效以及在隨機對照試驗環境中第 52 週的持久性確實非常強，針對核心生物學，人們可能期望更高的療效。

The steroid sparing that was built into our study will be an advantage to get people on to a single medicine at which point the durability and the convenience with every 6-month dosing after a loading dose are quite attractive, we believe, and we're receiving that feedback from prescribing physicians who waited in on these data in the program. Murdo, would you have any comments about the pricing dynamics?

我們研究中納入的類固醇節約將有利於讓人們只使用單一藥物，我們相信，在負荷劑量後每 6 個月服用一次的持久性和便利性非常有吸引力，並且我們正在從等待該計劃這些數據的處方醫生那裡收到反饋。Murdo，您對定價動態有什麼評論嗎？

Yeah. In general, in categories, is like this, the medical policies from the payers will follow the indications in the label and/or the inclusion criteria that we're provided for the clinical trial. So there's likely to be fairly broad access to these products now with real-world experience and our ability to generate real-world evidence in this category. I would think that the hypothesis that there might be a cost advantage to treating with UPLIZNA versus other agents could be borne out.

是的。一般來說，在這樣的類別中，付款人的醫療政策將遵循標籤中的指示和/或我們為臨床試驗提供的納入標準。因此，憑藉現實世界的經驗以及我們在此類別中產生現實世界證據的能力，現在這些產品很可能能夠得到相當廣泛的使用。我認為，使用 UPLIZNA 治療相對於其他藥物可能具有成本優勢這一假設是可以證實的。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Question on TEPEZZA. I feel like over the past couple of years, even talking expansively about a wider physician audience getting in front of more prescribers, raising awareness, product hasn't been growing. So I guess, what's it going to take to see an inflection here? Or maybe put differently, do you think there has to be some externality like the availability of a SubQ form to get the product really moving again?

關於 TEPEZZA 的問題。我覺得在過去的幾年裡，即使廣泛地談論讓更廣泛的醫生受眾接觸更多的處方者、提高意識，產品也沒有成長。所以我想，我們需要怎樣的努力才能看到​​這裡的轉折呢？或者換句話說，您是否認為必須有一些外部因素（例如 SubQ 形式的可用性）才能讓產品再次真正動起來？

Thanks for the question, David. I think we're actually making quite good progress in broadening the prescribing base for TEPEZZA. It is, as you mentioned, it is a progressive evolution given that the product started its journey in more serious higher CAS patients treated by the oculoplastic surgeon -- surgical community. And that's really what drove the initial uptake of the product. Going beyond that means that we have to activate general ophthalmologists and endocrinologists who are the really two challenges that we're working on with them.

謝謝你的提問，大衛。我認為我們在擴大 TEPEZZA 處方基礎方面實際上取得了相當大的進展。正如您所說，這是一個漸進式的演變，因為該產品最初是在眼整形外科醫生（外科界）治療的更嚴重的高位 CAS 患者中開始應用的。這才是該產品最初受到歡迎的真正原因。除此之外，我們還必須調動普通眼科醫生和內分泌科醫生的積極性，這是我們正在與他們共同應對的兩個真正挑戰。

One, getting them to actually take the time not just to diagnose Graves but to diagnose thyroid eye disease. And two, to initiate treatment with an infused biologic and then find the site of care. So all of that does take some time and some progress. But as I mentioned in prepared remarks, we're seeing a nice increase in intent to prescribe from endocrinologists and that's the earliest leading indicator.

首先，讓他們花時間不僅診斷格雷夫茲病，還要診斷甲狀腺眼疾。第二，先用注射的生物製劑治療，然後找到治療地點。所以所有這些都需要一些時間和一些進展。但正如我在準備好的發言中提到的那樣，我們看到內分泌科醫生的處方意願大幅增加，這是最早的領先指標。

We hope to follow that with an actual increase in prescribing. And then it will take time between when that intent and that prescription is written to when we can get that patient started on their first infusion. Navigating the payer process, finding a site of care does take some time as well. So it's not going to be a rapid change in the trajectory of the product, but it will be a progressive one.

我們希望隨之而來的是處方量的實際增加。然後，從該意圖和處方寫好到我們可以讓患者開始第一次輸液需要一些時間。瀏覽付款流程、尋找護理站點也需要一些時間。因此，產品軌跡不會發生快速變化，而是漸進的變化。

And then last but not least, definitely a subcutaneous administration will help here because it simplifies the site of care selection and affords more opportunities for patients to be initiated with their treatment. But I would anticipate both being able to grow prior to the availability of a subcutaneous form and then being able to accelerate that thereafter.

最後但同樣重要的一點是，皮下注射肯定會有所幫助，因為它簡化了治療部位的選擇，並為患者提供了更多開始治療的機會。但我預計，在皮下注射形式出現之前，它們都能夠生長，然後能夠加速生長。

And Murdo, maybe you want to touch on the international progress.

穆爾多，也許您想談談國際進展。

Yeah. Thanks, Justin. We've been making great progress with TEPEZZA internationally. With the recent approval in Japan, we've been approved in Saudi Arabia, Brazil, we have a positive opinion CHMP in Europe. We anticipate launching there in the back half of the year. So the international expansion is progressing very well, and I would say, ahead of schedule compared to what we thought we'd be able to do when we made the acquisition.

是的。謝謝，賈斯汀。我們與 TEPEZZA 在國際上取得了長足的進步。隨著最近在日本獲得批准，我們已在沙烏地阿拉伯、巴西獲得批准，我們對歐洲 CHMP 持正面評價。我們預計將在今年下半年推出產品。因此，國際擴張進展非常順利，我想說，與我們收購時預期的相比，這已經提前完成了。

Overall, the rare disease portfolio of products, it's a very young portfolio of products where we're really just beginning to address the severe diseases that these drugs treat -- and whether it's TEPEZZA, UPLIZNA, KRYSTEXXA or TAVNEOS, these are going to be key growth driving products for us over the long haul, both in the US and internationally.

總體而言，罕見疾病產品組合是一個非常年輕的產品組合，我們才剛開始解決這些藥物所治療的嚴重疾病——無論是 TEPEZZA、UPLIZNA、KRYSTEXXA 還是 TAVNEOS，從長遠來看，它們都將成為我們在美國和國際上推動成長的關鍵產品。

Speaking of youth, David, it's Peter here. Just a reminder that the transaction closed in October '23. So you mentioned a couple of years, it's been about a year and a half, although so much has happened in the world that might feel like more than that. So we're delighted with the progress so far. As I mentioned in my remarks, we're right on target with pretax cost synergies, and we're right on target with getting back to our pre-Horizon capital structure by the end of this year. So thanks for the question.

說到年輕人，大衛，我是彼得。需要提醒的是，交易於 23 年 10 月完成。所以你提到了幾年，其實已經過了大約一年半，儘管世界上發生了太多事情，感覺可能不只一年半。我們對迄今為止的進展感到非常高興。正如我在發言中提到的那樣，我們正朝著稅前成本協同效應的目標前進，並且我們正朝著在今年年底前恢復 Horizo​​​​n 資本結構的目標前進。感謝您的提問。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Congrats on all the progress, and thank you for providing this update. Can you help us understand what to expect on the bemarituzumab Phase 3 study readout coming up here in the second quarter? And how are you thinking about the market opportunity for Bema.

恭喜您取得的所有進展，並感謝您提供此更新。您能否幫助我們了解第二季即將發布的 bemarituzumab 第 3 階段研究結果有何預期？您如何看待 Bema 的市場機會？

Yeah. Thanks, Jay, for the kind words. Bemarituzumab is our first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody. This is a protein that appears on the surface of malignant gastric cancer cells with some frequency. And as you point out, we're conducting two prospective Phase 3 clinical trials, one that we call the doublet study or FORTITUDE 101.

是的。謝謝傑伊的善意言辭。Bemarituzumab 是我們一流的纖維母細胞生長因子受體 IIb 定向單株抗體。這是一種以一定頻率出現在惡性胃癌細胞表面的蛋白質。正如您所指出的，我們正在進行兩項前瞻性的 3 期臨床試驗，其中一項我們稱之為雙重研究或 FORTITUDE 101。

We expect this to read out in the second quarter of this year, as I shared in the opening remarks. What to expect here, we're very hopeful that this will meaningfully contribute to improve the overall survival in this patient population. We've designed an outstanding study that's fully enrolled, and we hope to have data to share in the next quarter. FORTITUDE-102 is the triplet study.

正如我在開場白中所說的那樣，我們預計該決議將在今年第二季公佈。我們非常希望這將對提高該患者群體的整體存活率做出有意義的貢獻。我們設計了一項出色的研究，目前已全部招募參與者，我們希望在下個季度分享數據。FORTITUDE-102 是一項三重研究。

This is where we combine bema with chemotherapy and checkpoint therapy nivolumab, both of these are frontline gastric cancer studies. And as more patients today receive or should receive chemotherapy with nivolumab in the frontline of this disease, we're very hopeful that bemarituzumab can work on top of that. with the data readout in the second half of this year. Bemarituzumab showed pretty strong data in Phase 2, especially in the target population that we selected. And so we're hopeful that this will become a component of frontline standard of care for this disease. I guess more to follow next quarter. Murdo?

這是我們將 Bema 與化療和檢查點療法 nivolumab 結合的地方，這兩者都是一線胃癌研究。如今，隨著越來越多的患者接受或應該接受納武單抗化療來治療這種疾病，我們非常希望貝馬利珠單抗能夠在此基礎上發揮療效。數據將於今年下半年公佈。Bemarituzumab 在第 2 階段表現出了相當強勁的數據，尤其是在我們選擇的目標群體中。因此，我們希望這將成為該疾病第一線護理標準的組成部分。我想下個季度還會有更多消息。默多？

Yeah. The addressable population here is quite large. This is the fifth most common cancer worldwide, over 1 million new cases globally, 25,000 cases in the US, the addressable -- initial addressable patient population of about 7,000 in the US much larger worldwide and a real opportunity in Japan and Southeast Asia, just in terms of the epidemiology of gastric cancer. And I think what really helps is as Jay outlined, the combinability of bemarituzumab with other available agents that treat this very difficult cancer.

是的。這裡的可尋址人口相當大。這是全球第五大常見癌症，全球新病例超過 100 萬，美國有 25,000 例，美國最初可尋址患者群體約為 7,000 人，在全球範圍內更為廣泛，僅從胃癌流行病學角度來看，這對日本和東南亞來說是一個真正的機會。我認為真正有幫助的是，正如傑伊所概述的，貝馬利珠單抗與其他可用的藥物相結合，可以治療這種非常難治的癌症。

Alexandra Hammond, Wolfe Research.

亞歷山德拉·哈蒙德，沃爾夫研究公司。

My apologies. Our next question will come from Gregory Renza, RBC Capital Markets.

我很抱歉。我們的下一個問題來自加拿大皇家銀行資本市場的 Gregory Renza。

Congrats on the quarter. Maybe just keeping with the oncology portfolio and maybe moving earlier down the pipeline a little bit. And as you build on the LUMAKRAS experience, just wanted to ask that you elaborate a bit on the KRAS franchise strategy, just particularly with the AMG 410 asset, which was recently highlighted at AACR. We have a world with a competitive landscape for KRAS drugs. Just curious if you could just elaborate how confident you are on the potential for 410 to be best or even better in class as you learn more about this molecule.

恭喜本季取得佳績。也許只是保留腫瘤學組合，也許稍微提早一點。在您累積了 LUMAKRAS 經驗之後，我只想請您稍微闡述 KRAS 特許經營策略，特別是最近在 AACR 上重點介紹的 AMG 410 資產。全球 KRAS 藥物的競爭十分激烈。我只是好奇，隨著您對這種分子了解的越來越多，您是否可以詳細說明一下，您對 410 成為同類產品中最好甚至更好的潛力有多大信心。

All right. Greg, thank you so much for picking up on the AMG 410 presentation at the AACR this week. This is a very interesting molecule. And I think you've covered two key attributes, which is the properties of the molecule itself to make it exciting and then the moment at which it reaches human clinical investigation. For others on the call that don't know the medicine, this is a low molecular weight orally bioavailable structure disclosed, a small molecule inhibitor of KRAS. Already, we were first to develop KRAS therapy as a reality with LUMAKRAS targeting the G12C allele selectively through cystine covalent chemistry.

好的。格雷格，非常感謝您本週參加 AACR 上的 AMG 410 演示。這是一個非常有趣的分子。我認為您已經涵蓋了兩個關鍵屬性，即分子本身的特性使其令人興奮，以及它進入人體臨床研究的那一刻。對於電話中不了解該藥物的其他人員，這是一種公開的低分子量口服生物可利用結構，是 KRAS 的小分子抑制劑。我們已經率先將 KRAS 療法變成現實，LUMAKRAS 透過胱胺酸共價化學選擇性地針對 G12C 等位基因。

But to get the other alleles that trick doesn't work. There's no cystine handle. And so we work to develop a reversible pan-KRAS inhibitor that hits wild-type G12D, G12V, G12C actually as well in G13D. It finds an allosteric pocket that is shared by other clinical-stage KRAS G12C inhibitors. This one is what's called a dual off and dual on-state inhibitor. It has outstanding selectivity for KRAS over HRAS and NRAS of more than 100 fold, which should confer excellent tolerability, a strong therapeutic index.

但對於取得其他等位基因來說，這個技巧不起作用。沒有胱氨酸手柄。因此，我們致力於開發一種可逆的泛 KRAS 抑制劑，該抑制劑實際上也能作用於野生型 G12D、G12V、G12C 和 G13D。它發現了一個與其他臨床階段 KRAS G12C 抑制劑共享的變構口袋。這就是所謂的雙關和雙開狀態抑制器。它對 KRAS 的選擇性比對 HRAS 和 NRAS 的選擇性高出 100 倍以上，因此具有極佳的耐受性和強大的治療指數。

And so we're developing this medicine in an expedited way in a number of target solid tumors, both alone and in combination in a combined Phase 1/2 design. So it's very -- it's a stunning molecule. Now it's a competitive space, and this is great for patients. We entered this space with AMG 410 being the leader in KRAS therapeutics. And so our eyes are wide open to some of the competitor programs that are more advanced in clinical study.

因此，我們正在針對多種目標實體腫瘤快速開發這種藥物，包括單獨治療和聯合治療，並採用 1/2 期聯合設計。所以它非常——是一種令人驚嘆的分子。現在這是一個競爭激烈的領域，這對患者來說是件好事。我們憑藉 AMG 410 進入這一領域，成為 KRAS 療法的領導者。因此，我們對一些在臨床研究方面更先進的競爭項目保持著密切關注。

I was very pleased to hear the reception from the leaders in the KRAS community at AACR, who on social media and in private conversations, were really bullish about the properties of 410 and the need. Some of the KRAS inhibitors have shown a more narrow therapeutic index than one might have hoped for. So competitive space, but an excellent offering, and we hope to learn a lot in expedited Phase 1 and 2 clinical development.

我很高興聽到 AACR KRAS 社群領導人的歡迎，他們在社群媒體和私人談話中對 410 的特色和需求非常樂觀。一些 KRAS 抑制劑表現出的治療指數比人們希望的要窄。雖然競爭非常激烈，但這是一個非常好的機會，我們希望在加速第 1 階段和第 2 階段臨床開發的過程中學到很多。

Matt Phipps, William Blair.

馬特菲普斯、威廉布萊爾。

I actually wanted to ask about the market opportunity for TEZSPIRE and CRS nasal polyps not an indication that gets talked a lot about. But particularly how much overlap there is with asthma patients and maybe your thoughts on the ability for biologics to move ahead of surgery longer term?

我實際上想問的是 TEZSPIRE 和 CRS 鼻息肉的市場機會，而不是人們經常談論的跡象。但具體來說，與氣喘患者的重疊程度有多大，以及您對生物製劑在長期內能否優於手術的看法？

Yeah. Thanks, Matt, for the question. There is indeed a real opportunity here with chronic rhinosinusitis with nasal polyps. We're looking at roughly 1 million to 2 million patients in the US that suffer from this. It is significantly overlapping with severe asthma, roughly 40% of asthma patients will present with some nasal polyps -- sorry, some chronic rhinosinusitis involvement and some of them with nasal polyps. And indeed, these patients undergo some very difficult treatments inclusive of surgery, and we were able to in our clinical trials show that we can reduce almost entirely the need for surgery.

是的。謝謝馬特提出這個問題。患有鼻息肉的慢性鼻竇炎確實存在真正的機會。我們發現美國大約有 100 萬到 200 萬患者患有這種疾病。它與嚴重氣喘有明顯的重疊，大約 40% 的氣喘患者會出現一些鼻息肉 - 抱歉，有些是慢性鼻竇炎引起的，有些是鼻息肉。事實上，這些患者接受了一些非常困難的治療，包括手術，而我們在臨床試驗中證明，我們幾乎可以完全減少手術的需要。

And so there is an opportunity, I believe, for us with TEZSPIRE, which has performed exceptionally well in severe uncontrolled asthma to go in and help these patients with this quite frankly, a miserable condition and help their overall quality of life as we demonstrated in the clinical trial.

因此，我相信，TEZSPIRE 對我們而言是一個機會，它在治療嚴重的不受控制的氣喘方面表現非常出色，坦率地說，它可以幫助這些患有這種痛苦疾病的患者，並幫助他們提高整體生活質量，正如我們在臨床試驗中所證明的那樣。

All right. Let's go to our last question.

好的。讓我們來討論最後一個問題。

Alexandria Hammond, Wolfe Research.

亞歷山大‧哈蒙德，沃爾夫研究公司。

So what's your expectation for future market split between Rocatinlimab and Sanofi’s competitor OX40? Are you thinking a 50-50 split in, let's say, the atopic dermatitis market? Or how are you kind of thinking about that shaking out?

那麼您對 Rocatinlimab 和賽諾菲競爭對手 OX40 未來的市場分割有何預期？您是否認為，在異位性皮膚炎市場中，各佔一半呢？或者你對這種震動有什麼看法？

Sure. Murdo, why don't you fire away.

當然。默多，你為什麼不開槍？

As we've said in the past, we're really looking carefully at the rocatinlimabopportunity. Atopic dermatitis is clearly a condition that has opportunity for continued improvement in terms of the number of treatments that are available, there's a large refractory patient population out there with respect to what they currently have available to them and how they respond. It's hard for me to speculate on what our market splits going to be versus agents that are still in clinical development. But we're quite confident that there's a very nice opportunity in the market for rocatinlimab.

正如我們過去所說的那樣，我們正在認真考慮 rocatinlimab 機會。就可用的治療方法而言，異位性皮膚炎顯然是一種具有持續改善機會的疾病，就目前可用的治療方法和反應而言，存在大量難治性患者。我很難推測我們的市場與仍處於臨床開發階段的藥物之間的差距。但我們非常有信心，rocatinlimab 在市場上有著非常好的機會。

All right. Well, thank you all for joining our call. We appreciate your interest. Justin and his team will be around for the balance of the day. If you have any questions that you didn't get a chance to ask. And as you can tell, we're excited about the momentum of the business, excited about the current performance as well as what we see coming down the pike. So look forward to seeing you later in the year. Thank you.

好的。好吧，感謝大家參加我們的電話會議。感謝您的關注。賈斯汀和他的團隊將會在當天剩餘時間陪伴大家。如果您有任何還沒有機會提出的問題。如您所知，我們對業務的發展勢頭感到興奮，並對當前的表現以及未來的表現感到興奮。期待今年稍晚能見到您。謝謝。

This concludes our Amgen Q1 FY 2025 earnings call.

安進 2025 財年第一季財報電話會議到此結束。