美國安進 (AMGN) 2024 Q4 法說會逐字稿

My name is Julianne, and I will be your conference facilitator today for Amgen's fourth quarter and full year 2024 financial results conference call. (Operator Instructions) I would now like to introduce Justin Claeys, Vice President of Investor Relations.

我叫朱莉安，今天我將擔任安進 2024 年第四季和全年財務業績電話會議的主持人。 （操作員指示）現在，我想介紹投資者關係副總裁賈斯汀·克萊斯 (Justin Claeys)。

Mr. Claeys, you may now begin.

克萊斯先生，現在您可以開始了。

Thank you, Julianne.

謝謝你，茱麗安。

Good afternoon, everyone, and welcome to our fourth quarter 2024 earnings call.

大家下午好，歡迎參加我們 2024 年第四季財報電話會議。

Bob Bradway will lead the call and be followed by a broader review of our performance by Murdo Gordon, Jay Bradner, and Peter Griffith.

鮑勃·布拉德韋 (Bob Bradway) 將主持此次電話會議，隨後穆爾多·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。

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.

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了適當的對帳。

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.

我們也將做出一些符合我們的安全港聲明的前瞻性陳述，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。

Good afternoon, everyone, and thank you for joining us today. 2024 capped another year of strong execution at Amgen.

大家下午好，感謝大家今天的參與。 2024 年是安進公司又一個強勁執行力的一年。

Our operations teams supplied "every patient every time".

我們的營運團隊「每次都為每位患者提供服務」。

Our clinical teams reliably delivered quality results across the portfolio.

我們的臨床團隊在整個產品組合中可靠地提供了高品質的結果。

And our commercial teams grew the business across our four therapeutic areas and in each of our geographic regions.

我們的商業團隊在四個治療領域和每個地理區域拓展了業務。

The operating rhythm that we've established in our business will serve us well for 2025 and the longer term.

我們在業務中建立的營運節奏將在2025年及更長時間內為我們帶來良好的效益。

Looking ahead, our objective is to deliver long-term growth while navigating regulatory and political change, declining net prices and losses of exclusivity.

展望未來，我們的目標是實現長期成長，同時應對監管和政治變化、淨價格下降和獨家經營權喪失。

We have a track record of doing just that.

我們曾經這樣做過。

If you consider the past decade, we grew revenues above a mid single-digit percent level and EPS at approximately 9% per year over the period, despite facing biosimilar and generic competition across products that accounted for about 50% of our revenues.

如果回顧過去十年，儘管我們約有 50% 的收入產品面臨生物相似藥和仿製藥的競爭，但我們的收入仍保持在中等個位數百分比以上的增長，每股收益在此期間保持在約 9% 的增長率。

As we look to the next decade, our novel medicines are well positioned to address patient demographics in a rapidly aging world, and we expect that our operating discipline to enable us to scale to meet the needs of patients while continuing to deliver for our shareholders.

展望未來十年，我們的新藥物將很好地滿足快速老化世界中的患者人口統計需求，並且我們期望我們的營運紀律使我們能夠擴大規模以滿足患者的需求，同時繼續為股東帶來收益。

Reflecting on our marketed products in 2024, we exited the fourth quarter with 14 medicines, each annualizing at over a $1 billion and notably several of these will be key drivers of growth through the decade.

回顧我們在 2024 年銷售的產品，我們在第四季度結束時擁有 14 種藥物，每種藥物的年銷售額都超過 10 億美元，值得注意的是，其中一些將成為未來十年增長的主要驅動力。

Let me highlight a few.

讓我強調幾點。

Starting in general medicine, Repatha and EVENITY continue to deliver attractive growth.

從普通醫學開始，Repatha 和 EVENITY 繼續實現可觀的成長。

Heart disease remains the leading cause of death globally.

心臟病仍然是全球最大的死亡原因。

And Repatha, now a multi-billion dollar product continues to expand as access improves worldwide.

如今，Repatha 已成為價值數十億美元的產品，隨著全球可及性的改善，其市場規模仍在擴大。

We are the leader worldwide in bone health, addressing the huge need for fracture prevention in those living with osteoporosis.

我們是全球骨骼健康領域的領導者，致力於滿足骨質疏鬆症患者對預防骨折的巨大需求。

The clinical performance of EVENITY since its launch demonstrates the leading role it can play in reducing fracture risk for millions of postmenopausal women.

EVENITY 自上市以來的臨床表現證明了其在降低數百萬停經後婦女骨折風險方面發揮的主導作用。

In rare diseases, 2025 will be an exciting year.

在罕見疾病領域，2025年將是令人興奮的一年。

We look forward to regulatory approvals for TEPEZZA internationally and launches in new indications for UPLIZNA further strengthening the growth trajectory of our rare disease business.

我們期待 TEPEZZA 獲得國際監管部門的批准，並推出 UPLIZNA 的新適應症，進一步加強我們罕見疾病業務的成長軌跡。

In inflammation, we continue to be inspired by the strong performance of TEZSPIRE and the progress we're making advancing into new indications, including COPD, which is the third leading cause of death, where we intend to initiate Phase 3 studies.

在發炎方面，我們繼續受到 TEZSPIRE 強烈表現的啟發，以及我們在新適應症方面取得的進展，其中包括慢性阻塞性肺病 (COPD)，它是第三大死亡原因，我們打算啟動第三階段研究。

And of course, in chronic rhinosinusitis which runs in parallel with other respiratory diseases.

當然，慢性鼻竇炎是與其他呼吸系統疾病同時發生的。

In oncology, our leading bispecific T-cell engager platform provides further opportunities for growth, with BLINCYTO moving into frontline treatment and demonstrating compelling survival benefit in B-ALL.

在腫瘤學領域，我們領先的雙特異性T細胞接合平台提供了進一步的成長機會，BLINCYTO 進入一線治療領域並在 B-ALL 中表現出令人信服的生存益處。

IMDELLTRA, showing impressive efficacy and hard to treat small cell lung cancer and xaluritamig advancing into Phase 3 in advanced prostate cancer.

IMDELLTRA 顯示出令人印象深刻的療效，並且可治療難以治療的小細胞肺癌，xaluritamig 在晚期前列腺癌治療中進入第 3 期。

2025 promises to be another milestone year for our rapidly advancing pipeline.

2025 年有望成為我們快速發展的管道的另一個里程碑。

With important Phase 3 data readouts for programs, including across our general medicine, rare disease, inflammation and oncology portfolios.

包括我們的普通醫學、罕見疾病、發炎和腫瘤學等項目在內的重要第 3 階段數據讀數。

Beyond these readouts, we'll be initiating several new Phase 3 trials of MariTide in obesity and related conditions.

除了這些讀數之外，我們還將啟動 MariTide 在肥胖症和相關疾病方面的幾項新的 3 期試驗。

This is an exciting time for innovation in our laboratories, in our factories, with the science of manufacturing, and in leveraging technology across the company.

這是一個令人興奮的時刻，我們的實驗室、工廠、製造科學以及整個公司的技術都在進行創新。

When it comes to artificial intelligence, we're finding new opportunities across our business, and AI is helping us deliver innovative medicines to more patients even faster.

在人工智慧方面，我們在整個業務中發現了新的機遇，人工智慧正在幫助我們更快地向更多患者提供創新藥物。

To wrap up, 2024 demonstrated the strength of our business, the depth and breadth of our portfolio and the power of our pipeline.

總而言之，2024 年展現了我們業務的實力、我們產品組合的深度和廣度以及我們產品線的強大力量。

As we step into 2025, we're poised to deliver continued growth and innovation in the near term through 2030 and beyond.

當我們邁入 2025 年時，我們準備在近期、2030 年及以後實現持續的成長和創新。

And I want to thank our global team for their exceptional contributions and dedication to our mission.

我要感謝我們的全球團隊為我們使命所做的傑出貢獻和奉獻。

With that, I'll turn it over to Murdo for an update on our commercial organization.

說完這些，我將把話題轉交給 Murdo，以介紹我們商業組織的最新情況。

Thanks, Bob.

謝謝，鮑伯。

In the fourth quarter, product sales grew 11% year over year, capping off a year of growth fueled by strong execution across the business.

第四季度，產品銷售額年增11%，在整個業務強勁執行力的推動下，為全年的成長畫上了圓滿的句號。

For the full year, product sales grew 19% and 10 products grew by double-digits or better, creating strong momentum for growth in 2025 and beyond.

全年產品銷售額成長19%，10款產品實現兩位數或以上成長，為2025年及以後的成長創造了強勁勢頭。

Two products on a strong growth trajectory, are Repatha and EVENITY, which together grew 35% year-over-year, driven by 39% volume growth and accounting for nearly $1 billion in sales growth in the year.

兩種成長強勁的產品是 Repatha 和 EVENITY，它們合計年增 35%，其中銷量成長 39%，全年銷售額成長近 10 億美元。

Both of these important brands serve large patient populations that are mostly untreated, despite the availability of highly impactful therapies, indicating robust growth potential.

儘管目前存在高效療法，但這兩個重要品牌仍服務於大量未治療的患者群體，這表明其具有強勁的成長潛力。

Repatha sales increased 36% in 2024, reaching over $2.2 billion in sales.

2024 年，Repatha 的銷售額將成長 36%，達到 22 億美元以上。

There are 100 million patients globally in need of effective treatment for lowering their LDL-C, and we see strong potential for growth of Repatha around the world as physicians, patients and payers recognize the importance of therapies like Repatha for patients at risk of major cardiovascular events.

全球有 1 億患者需要有效的治療來降低他們的 LDL-C，隨著醫生、患者和付款人認識到 Repatha 等療法對於有重大心血管事件風險的患者的重要性，我們看到 Repatha 在全球範圍內擁有強大的增長潛力。

In the United States, Repatha sales grew 44% in 2024 with volume growth of 54%.

在美國，Repatha 的銷售額在 2024 年成長了 44%，銷量成長了 54%。

The majority of patients with elevated LDL-C are in the primary care setting.

大多數 LDL-C 升高的患者均處於初級保健環境中。

And in 2024, our increased investment focused on primary care physicians improved the number of Repatha prescribers by 50%, supporting future growth strategy.

2024 年，我們增加了對初級保健醫生的投資，將 Repatha 處方人數提高了 50%，為未來的成長策略提供了支持。

Our direct patient education efforts doubled the number of patients who ask their doctor for Repatha.

我們直接對患者的教育工作使向醫生諮詢 Repatha 的患者數量增加了一倍。

Volume growth was further supported by Repatha's broad access and reimbursement, and we see more payers seeking to ease or even remove prior authorization barriers, making Repatha more accessible and affordable for patients.

Repatha 的廣泛獲取和報銷進一步支持了銷售成長，我們看到越來越多的付款人尋求緩解甚至消除事先授權障礙，使患者更容易獲得 Repatha 並且負擔得起。

Cardiologists and primary care physicians reported in a recent survey that Repatha access has improved significantly versus two years ago.

心臟科醫生和初級保健醫生在最近的一項調查中報告稱，與兩年前相比，Repatha 的可及性有了顯著改善。

Outside the US, Repatha continues to grow across major markets despite increased competition in the segment.

在美國以外，儘管該領域的競爭日益激烈，但 Repatha 仍在主要市場持續成長。

Over the past several years, the price of Repatha has been impacted by an expansion of coverage in the US and the growth of new markets around the world.

在過去幾年中，Repatha 的價格受到美國覆蓋範圍擴大和全球新市場成長的影響。

Moving forward, we expect less price erosion for Repatha with 2025 net price expected to decline by mid single-digits or less.

展望未來，我們預期 Repatha 的價格下滑幅度會較小，預計 2025 年淨價將下降中等個位數或更低。

EVENITY sales increased 35% in 2024, reaching almost $1.6 billion in sales.

2024 年 EVENITY 的銷售額將成長 35%，達到近 16 億美元。

EVENITY is the only therapeutic that both builds bone and slows resorption, which can play a critical role in reducing fracture risk for millions of women who are postmenopausal.

EVENITY 是唯一一種既能增強骨骼又能減緩吸收的治療方法，對降低數百萬停經後女性的骨折風險起到關鍵作用。

Despite the significant need, only 210,000 patients in the US have been treated with EVENITY to date, while millions remain at risk.

儘管需求龐大，但迄今為止，美國祇有 21 萬名患者接受了 EVENITY 治療，而數百萬患者仍然面臨風險。

With over 90% of very high-risk patients not currently receiving appropriate treatment, we see a significant opportunity to grow EVENITY in 2025 and beyond.

目前，超過 90% 的高風險患者未得到適當的治療，我們認為 EVENITY 在 2025 年及以後具有巨大的發展機會。

In the US, EVENITY continues to be the segment leader in the bone builder market.

在美國，EVENITY 繼續成為骨骼增強劑市場的領導者。

We drove a 14% quarter-over-quarter increase in new customers ordering EVENITY and saw an increase in prescription volume from both established and new EVENITY prescribers.

我們推動 EVENITY 新客戶訂購量較上季成長 14%，並且來自現有和新 EVENITY 處方者的處方量均有所增加。

We've increased our investment in EVENITY and have fully shifted the focus of our US bone field force towards EVENITY.

我們加大了對EVENITY的投入，將美國骨科領域力量的重點全面轉向EVENITY。

I'll move to our rare disease portfolio, which delivered over $4.5 billion in sales in 2024.

我將轉到我們的罕見疾病產品組合，該產品組合在 2024 年的銷售額超過 45 億美元。

TEPEZZA, our largest product in the rare disease portfolio generated sales of $1.9 billion in the year, representing 5% year-on-year growth.

TEPEZZA 是我們罕見疾病產品組合中最大的產品，全年銷售額達 19 億美元，較去年同期成長 5%。

Since launch, TEPEZZA has had a positive impact for thousands of patients living with thyroid eye disease.

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。

There are roughly 100,000 patients suffering from thyroid eye disease in the US who could benefit from TEPEZZA.

美國約有 10 萬名患有甲狀腺眼疾的患者可以從 TEPEZZA 中受益。

And to reach them, we've intensified our efforts to engage a broad prescriber base of oculoplastic surgeons, ophthalmologists and endocrinologists.

為了惠及他們，我們加大了力度，廣泛吸收眼科整形外科醫師、眼科醫師和內分泌科醫師作為處方醫師。

We're moving quickly in international markets to secure regulatory approval for TEPEZZA, which will drive additional growth, and we've successfully launched TEPEZZA in Japan, where it's the first and only medicine approved to treat active thyroid eye disease.

我們正在國際市場上迅速採取行動，爭取獲得 TEPEZZA 的監管批准，這將推動進一步的增長，並且我們已在日本成功推出 TEPEZZA，它是日本第一個也是唯一一個獲準治療活動性甲狀腺眼病的藥物。

In 2025, we expect to launch TEPEZZA in seven additional countries.

2025 年，我們預計將在另外 7 個國家推出 TEPEZZA。

In inflammation, TEZSPIRE continues its strong trajectory with nearly $1 billion in sales in the year, a 71% year over year increase.

在發炎方面，TEZSPIRE 繼續保持強勁成長勢頭，今年的銷售額接近 10 億美元，年增 71%。

We've driven increased adoption by pulmonologists supported by TEZSPIRE's unique profile to treat patients with multiple severe, uncontrolled asthma triggers and drivers.

我們推動了肺病專家更多地採用 TEZSPIRE 的獨特特性來治療患有多種嚴重、無法控制的氣喘觸發因素和驅動因素的患者。

TEZSPIRE has strong future growth potential, given the need to treat the 2.5 million patients worldwide with severe, uncontrolled asthma.

鑑於全球有 250 萬名患有嚴重、無法控制的氣喘的患者需要治療，TEZSPIRE 具有強勁的未來成長潛力。

Our innovative oncology portfolio, including BLINCYTO, LUMAKRAS, Vectibix, KYPROLIS, Nplate, XGEVA and IMDELLTRA, contributed almost $8 billion in sales for the full year.

我們創新的腫瘤學產品組合，包括 BLINCYTO、LUMAKRAS、Vectibix、KYPROLIS、Nplate、XGEVA 和 IMDELLTRA，全年貢獻了近 80 億美元的銷售額。

Year over year sales grew 11%, driven by volume growth and higher net selling price.

由於銷量成長和淨售價上漲，銷售額較去年同期成長 11%。

Our leading bispecific T-cell engager platform, which developed BLINCYTO and IMDELLTRA, continues to address critical unmet needs in oncology while providing significant opportunities for future growth.

我們領先的雙特異性T細胞接合平台開發了BLINCYTO和IMDELLTRA，它繼續解決腫瘤學領域尚未滿足的關鍵需求，同時為未來的發展提供重大機會。

BLINCYTO sales grew 41% for the full year, reaching over $1.2 billion in sales.

BLINCYTO 全年銷售額成長 41%，達到 12 億美元以上。

We expect continued strong growth in 2025, driven by broad prescribing across academic and community segments.

我們預計，在學術界和社區領域廣泛處方的推動下，2025 年將繼續保持強勁成長。

Physician prescribing is growing and compelling new clinical data is redefining BLINCYTO as the standard of care for both adult and pediatric patients with Philadelphia chromosome negative B-cell ALL.

醫生的處方量正在增長，令人信服的新臨床數據正在將 BLINCYTO 重新定義為費城染色體陰性 B 細胞 ALL 成人和兒童患者的標準治療方法。

Our US launch of IMDELLTRA for the treatment of patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy is off to a strong start, generating $115 million in sales in seven months since launch.

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 取得了良好的開端，自推出以來七個月內創造了 1.15 億美元的銷售額。

We see increasing breadth of adoption in both academic and community settings driven by strong clinical conviction for IMDELLTRA's transformational efficacy.

我們看到，由於臨床上對 IMDELLTRA 的轉化功效有著強烈的信心，其在學術界和社區環境中的採用範圍越來越廣。

IMDELLTRA has treated approximately 2,000 patients since launch.

IMDELLTRA 自推出以來已治療了約 2,000 名患者。

Each year, an estimated 8,000 to 10,000 patients progress to second line treatment for extensive stage small cell lung cancer.

每年估計有 8,000 至 10,000 名廣泛期小細胞肺癌患者進入二線治療。

Our medical and commercial teams are operating with urgency to bring IMDELLTRA to more patients living with this aggressive disease.

我們的醫療和商業團隊正在緊急行動，將 IMDELLTRA 帶給更多患有這種惡性疾病的患者。

Sales of our biosimilar products were $2.2 billion in 2024, an increase of 16% year-over-year.

2024年，我們的生物相似藥銷售額為 22 億美元，年成長 16%。

In the fourth quarter, our team readily executed the launch of PAVBLU, a biosimilar to EYLEA with nine weeks of sales totaling $31 million.

第四季度，我們的團隊順利完成了EYLEA生物相似藥PAVBLU的上市，上市九週累計銷售額達3,100萬美元。

Response from retina specialists to PAVBLU has been very positive with strong intent to purchase and administer this high-quality Amgen biosimilar, delivered in an easy-to-use pre-filled syringe.

視網膜專家對 PAVBLU 的反應非常積極，他們強烈希望購買並使用這種高品質的安進生物仿製藥，該藥物採用易於使用的預充式註射器輸送。

The next wave of biosimilar launches continues in 2025.

下一波生物相似藥的上市將在 2025 年繼續。

In January, building on the strong introduction of PAVBLU at the end of 2024, we launched WEZLANA, a biosimilar to STELARA.

今年 1 月，在 2024 年底強勢推出 PAVBLU 的基礎上，我們推出了 STELARA 的生物相似藥 WEZLANA。

And in the second quarter, we expect to launch BKEMV, a biosimilar to SOLIRIS.

我們預計將在第二季推出 SOLIRIS 的生物相似藥 BKEMV。

With this next wave of launches, we anticipate robust growth and attractive returns from our biosimilar portfolio.

隨著下一波產品的推出，我們預計我們的生物相似藥產品組合將實現強勁成長和可觀的回報。

2024 was a strong year of execution across Amgen.

2024 年是安進公司執行力強勁的一年。

We view execution as a team effort.

我們認為執行是一項團隊努力。

The tightly coordinated integration between research and development, manufacturing operations, and our commercial teams enables us to serve record numbers of patients across the portfolio and around the world.

透過研發、製造營運和商業團隊之間緊密協調的整合，我們能夠為整個產品組合和世界各地的創紀錄數量的患者提供服務。

This relentless cross-enterprise focus will accelerate our ability to reach even more patients with Amgen medicines in 2025.

這種堅持不懈的跨企業關注將加速我們在 2025 年為更多患者提供安進藥物的能力。

And with that, I'll hand it over to Jay.

現在我將把麥克風交給傑伊。

Thank you, Murdo, and good afternoon, everyone.

謝謝你，Murdo，大家下午好。

At this time last year, we planned a very ambitious R&D agenda, and I'm very proud to say we delivered, meeting or exceeding almost all enrollment targets and generating impact and value across the portfolio.

去年此時，我們制定了一項非常雄心勃勃的研發議程，我很自豪地說，我們實現或超過了幾乎所有的招生目標，並對整個投資組合產生了影響和價值。

Specifically, in 2024, we received two important US regulatory approvals in oncology, completed five positive Phase 3 studies, and initiated three new Phase 3 trials while advancing the broad MariTide program.

具體而言，2024年，我們獲得了美國腫瘤學領域的兩項重要監管批准，完成了五項積極的 3 期研究，並在推進廣泛的 MariTide 計劃的同時啟動了三項新的 3 期試驗。

Let's begin with MariTide, a therapy with a unique, differentiated and highly competitive profile.

讓我們從 MariTide 開始吧，這是一種具有獨特、差異化和高度競爭力的治療方法。

Since our Phase 2 data disclosure last November, we have engaged extensively with key opinion leaders and have received strong enthusiasm and support.

自去年 11 月第二階段數據揭露以來，我們與關鍵意見領袖進行了廣泛的接觸，並獲得了強烈的熱情和支持。

This excitement stems from MariTide's ability to deliver consistent, predictable and sustained weight loss through 52 weeks without hitting a weight loss plateau and convenient monthly or less frequent dosing, a clear advantage over current weekly therapies.

這種令人興奮的感覺源於 MariTide 能夠在 52 週內實現一致、可預測且持續的減肥效果，且不會達到減肥平台期，並且每月或更短時間服用一次非常方便，這比目前的每週療法具有明顯的優勢。

Additionally, key opinion leaders conveyed their excitement for robust and clinically meaningful improvements in cardiometabolic parameters, including hemoglobin A1c, demonstrated by MariTide treatment.

此外，關鍵意見領袖對 MariTide 治療所證實的糖化血紅蛋白 (A1c) 等心臟代謝參數的強勁和具有臨床意義的改善表示興奮。

With a further optimized simple dose escalation schedule and significantly fewer injections per year, we expect to improve persistent and long-term health outcomes.

透過進一步優化簡單的劑量遞增計劃和顯著減少每年的注射次數，我們希望改善持續和長期的健康結果。

MariTide represents a promising treatment advance for people living with obesity and related conditions, and we are committed to fully realizing its potential.

MariTide 代表肥胖症及相關疾病患者治療的一項有希望的進步，我們致力於充分發揮它的潛力。

In the first half of 2025, we expect to initiate the first studies in our broad Phase 3 MARITIME program and expect to present the full MariTide Phase 2 data set at a major medical congress.

我們預計將在 2025 年上半年啟動廣泛的 3 期 MARITIME 計劃的首批研究，並預計在大型醫學會議上展示完整的 MariTide 2 期數據集。

In the second half of 2025, we expect key data readouts from both the ongoing Phase 2 type 2 diabetes study and Part 2 of the ongoing Phase 2 chronic weight management study.

2025 年下半年，我們預計將獲得正在進行的第 2 階段 2 型糖尿病研究和正在進行的第 2 階段慢性體重管理研究第 2 部分的關鍵數據讀數。

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.

除了 MariTide，在一般醫學領域，我們期待今年下半年 Repatha VESALIUS 第 3 期一級預防研究的數據。

Having demonstrated profound and sustained benefit of Repatha in the secondary prevention setting, we're excited about these data and the opportunity to reach additional patients at high risk of a first cardiovascular event.

由於證明了 Repatha 在二級預防環境中具有深遠而持續的益處，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機會感到非常興奮。

Turning to Olpasiran, our promising best-in-class small interfering RNA medicine targeting Lp(a), we are bringing a precision medicine to cardiovascular risk reduction for the many individuals with Lp(a) elevation.

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) 升高患者提供​​降低心血管風險的精準醫療。

The fully enrolled OCEAN(a) Phase 3 cardiovascular outcomes trial of olpasiran continues to progress, and we expect to initiate an additional Phase 3 outcomes study in patients with elevated Lp(a) and at high risk for a first cardiovascular event late this year, or in the first half of 2026.

奧帕西蘭的 OCEAN(a) 第 3 期心血管結果試驗已全面入組，目前正在繼續推進中，我們預計將在今年稍後或 2026 年上半年針對 Lp(a) 升高且首次心血管事件風險較高的患者啟動一項額外的第 3 期結果研究。

Shifting to rare disease, we are very excited about UPLIZNA's potential to serve even more patients facing rare inflammatory illnesses.

轉向罕見疾病，我們對 UPLIZNA 為更多面臨罕見發炎疾病的患者提供服務的潛力感到非常興奮。

In 2024, we generated compelling data from the UPLIZNA Phase 3 MITIGATE study in patients with IgG4 related disease, a serious inflammatory condition with no approved therapies.

2024 年，我們從 UPLIZNA 第 3 期 MITIGATE 研究中獲得了令人信服的數據，該研究針對患有 IgG4 相關疾病的患者，這是一種嚴重的發炎疾病，目前尚無核准的治療方法。

These data are now under FDA priority review with a PDUFA date of April 3, 2025.

這些數據目前正在接受 FDA 優先審查，PDUFA 日期為 2025 年 4 月 3 日。

The FDA also granted orphan drug designation to UPLIZNA for the treatment of generalized myasthenia gravis based upon 26 week data from the Phase 3 MINT study.

FDA 也根據 MINT 第三階段研究的 26 週數據，授予 UPLIZNA 孤兒藥物資格，用於治療全身性重症肌無力。

This study showed UPLIZNA to be highly effective on multiple clinical outcomes, also reducing the need for steroids with patient-centered convenient dosing.

這項研究表明，UPLIZNA 對多種臨床結果非常有效，同時透過以患者為中心的便利用藥減少了對類固醇的需求。

We eagerly anticipate the 52 week data later this year, which will provide further insight into response and long-term durability.

我們熱切期待今年稍後的 52 週數據，這將為反應和長期耐用性提供進一步的見解。

With two anticipated approvals on the horizon in IgG4 related disease and generalized myasthenia gravis, we are more confident than ever about UPLIZNA's expanding impact on the management of rare inflammatory diseases.

隨著 IgG4 相關疾病和全身性重症肌無力兩項治療藥物即將獲得批准，我們比以往任何時候都更加相信 UPLIZNA 在罕見發炎疾病管理方面日益擴大的影響力。

In inflammation, we remain on track to initiate Phase 3 studies of TEZSPIRE in COPD, 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，我們仍在按計劃啟動 TEZSPIRE 在 COPD 的 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 個細胞的中度至極重度 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.

COPD 是世界第三大死因，我們對 TEZSPIRE 在這一領域可能發揮的影響感到非常興奮。

Beyond COPD, regulatory submissions are underway in chronic rhinosinusitis with nasal polyps supported by positive Phase 3 data, and we continue advancing a Phase 3 study in eosinophilic esophagitis.

除慢性阻塞性肺病 (COPD) 外，我們還在進行伴有鼻息肉的慢性鼻竇炎的監管提交，並得到了積極的 3 期數據支持，並且我們正在繼續推進嗜酸性食道炎的 3 期研究。

The Rocatinlimab Phase 3 ROCKET program in atopic dermatitis is progressing, with additional data expected throughout 2025.

Rocatinlimab 治療異位性皮膚炎的 III 期 ROCKET 計畫正在取得進展，預計 2025 年將獲得更多數據。

These studies will provide deeper insight into Rocatinlimab's profile.

這些研究將提供對 Rocatinlimab 特性的更深入了解。

Beyond atopic dermatitis, we continue to explore Rocatinlimab in moderate-to-severe asthma and prurigo nodularis, a chronic skin condition characterized by extreme itchiness.

除了異位性皮膚炎之外，我們還將繼續探索 Rocatinlimab 在中度至重度氣喘和結節性癢疹（一種以極度搔癢為特徵的慢性皮膚病）中的應用。

As previously indicated, we are pursuing B-cell depletion in autoimmune disease with both blinatumomab and inebilizumab.

如前所述，我們正在利用 blinatumomab 和 inebilizumab 來治療自體免疫疾病中的 B 細胞耗竭。

Our initial focus is on systemic lupus erythematosuswith plans to expand into additional indications.

我們最初的重點是系統性紅斑狼瘡，並計劃擴展到其他適應症。

2025 will be an important year in oncology, where we expect 3 key Phase 3 data readouts.

2025 年將是腫瘤學領域的重要一年，我們預計將獲得 3 個關鍵的 3 期數據。

I will start with our rapidly advancing BiTE portfolio.

我首先會介紹我們快速發展的 BiTE 產品組合。

Last December, very exciting BLINCYTO data were shared at ASH and published simultaneously in the New England Journal of Medicine.

去年 12 月，非常令人興奮的 BLINCYTO 數據在 ASH 上分享，並同時發表在《新英格蘭醫學雜誌》上。

In a Phase 3 study conducted by the Children's Oncology Group, BLINCYTO added to chemotherapy improved three-year disease-free survival to 96% compared to 88% with chemotherapy alone in the upfront treatment of pediatric B-cell acute lymphoblastic leukemia.

在兒童腫瘤組進行的 3 期研究中，BLINCYTO 與化療聯合用於兒童 B 細胞急性淋巴細胞白血病的初始治療，三年無病存活率提高至 96%，而單純化療的三年無疾病存活率僅為 88%。

We are also advancing a subcutaneous formulation of blinatumomab with a potentially registration-enabling study in adults and adolescents with relapsed/refractory B-ALL expected to begin in the second half of 2025.

我們也正在推進 blinatumomab 的皮下製劑研究，並計劃於 2025 年下半年針對復發/難治性 B-ALL 成人和青少年患者開展一項具有註冊資格的研究。

Based on our experience to-date, subcutaneous blinatumomab has the potential to improve the patient experience, efficacy and tolerability.

根據我們迄今為止的經驗，皮下注射博納吐單抗有可能改善患者的體驗、療效和耐受性。

Our second approved BiTE therapy, IMDELLTRA, a first-in-class bispecific T-cell engager targeting DLL3 for small cell lung cancer, is rapidly advancing into earlier lines of therapy.

我們的第二種核准的 BiTE 療法 IMDELLTRA 是一種針對小細胞肺癌的 DLL3 的同類首創雙特異性 T 細胞接合劑，正迅速推進至早期治療領域。

Phase III studies are ongoing in both extensive-stage and limited-stage disease.

廣泛期和有限期疾病的 III 期研究正在進行中。

Data from DeLLphi-304 are expected in the first half of 2025.

DeLLphi-304 的數據預計將在 2025 年上半年公佈。

This study compares IMDELLTRA with standard-of-care chemotherapy in second-line, extensive-stage, small cell lung cancer.

這項研究比較了 IMDELLTRA 與二線廣泛期小細胞肺癌的標準化療。

Our first-in-class STEAP1 CD3 bispecific T-cell engager xaluritamig has entered Phase 3 clinical development with a study in post-taxane, metastatic castrate-resistant prostate cancer.

我們一流的 STEAP1 CD3 雙特異性 T 細胞接合劑 xaluritamig 已進入第 3 階段臨床開發，並針對紫杉烷後轉移性去勢抵抗性前列腺癌進行研究。

We are also exploring xaluritamig in combination therapy and in earlier lines of prostate cancer with multiple Phase 1b studies ongoing.

我們也正在探索 xaluritamig 在聯合療法和前列腺癌早期治療中的應用，目前正在進行多項 1b 期研究。

We remain excited about the growth potential of our BiTE platform and the opportunity to reach additional cancer patients with BLINCYTO, IMDELLTRA and xaluritamig.

我們對於 BiTE 平台的成長潛力以及透過 BLINCYTO、IMDELLTRA 和 xaluritamig 接觸更多癌症患者的機會仍然感到興奮。

Beyond our T-cell engagers, bemarituzumab, our first-in-class fibroblast growth factor receptor 2b-directed monoclonal antibody, is advancing to frontline gastric cancer therapy.

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 2b 定向單株抗體 bemarituzumab 正在推進至一線胃癌治療。

We expect data in the first half of 2025 from FORTITUDE-101, a Phase 3 study of bemarituzumab combined with mFOLFOX6chemotherapy versus chemotherapy alone.

我們預計 2025 年上半年將獲得 FORTITUDE-101 的數據，該研究是關於 bemarituzumab 聯合 mFOLFOX6 化療與單獨化療的 3 期研究。

In the second half of 2025, we expect data from an analysis of FORTITUDE-102, a Phase 3 study of bemarituzumab combined with chemotherapy and nivolumab.

2025 年下半年，我們預計將獲得 FORTITUDE-102 分析的數據，該研究是貝馬利珠單抗聯合化療和 nivolumab 的 3 期研究。

On biosimilars, we are rapidly advancing three Phase 3 programs evaluating our biosimilars to OPDIVO, KEYTRUDA and OCREVUS, the next wave of Amgen biosimilar products.

在生物相似藥方面，我們正在迅速推進三個 3 期項目，評估我們的生物相似藥 OPDIVO、KEYTRUDA 和 OCREVUS（安進的下一波生物相似藥產品）。

In closing, I want to thank my Amgen colleagues for their unwavering commitment to patients facing grievous illnesses and for their focus and collaboration throughout a highly productive 2024.

最後，我要感謝安進公司的同事們，感謝他們對面臨嚴重疾病的患者的堅定承諾，感謝他們在富有成效的 2024 年的專注和合作。

We look forward to an exciting year ahead and continued pipeline momentum.

我們期待著令人興奮的新的一年以及持續的渠道建設發展勢頭。

I'll now turn it over to Peter.

現在我將把它交給彼得。

Thank you, Jay.

謝謝你，傑伊。

We're pleased with our execution excellence in the fourth quarter and for the full year 2024, and we remain on track with our long-term objectives.

我們對第四季度和 2024 年全年的卓越執行感到滿意，並且我們仍在朝著長期目標前進。

The financial results are shown on slides 28 to 30 of the slide deck.

財務結果顯示在投影片的第 28 至 30 頁。

Full year total revenues of $33.4 billion grew 19% year-over-year driven by 21 products with record sales.

全年總收入達 334 億美元，年增 19%，這得益於 21 款產品銷售量創紀錄。

Product sales increased 19% year-over-year driven by 23% volume growth.

產品銷量較去年同期成長19%，受銷量成長23%的推動。

Excluding products acquired from Horizon, product sales for the full year increased 7% year-over-year driven by 11% volume growth.

不包括從 Horizo​​​​n 收購的產品，全年產品銷售額年增 7%，受銷量成長 11% 的推動。

For the full year, we delivered a non-GAAP operating margin of 47%.

全年，我們的非公認會計準則營業利益率為 47%。

We continue to invest in advancing our pipeline with non-GAAP R&D spend increasing 25% year-over-year for the full year to a record $5.9 billion due to investments in the late-stage pipeline, including MariTide, Rocatinlimab, bemarituzumab and IMDELLTRA, as well as Horizon acquired programs.

我們繼續投資推動我們的產品線，非公認會計準則研發支出全年同比增長 25%，達到創紀錄的 59 億美元，這得益於對後期產品線的投資，包括 MariTide、Rocatinlimab、bemarituzumab 和 IMDELLTRA，以及 Horizo​​​​n 收購的項目。

Excluding Horizon, non-GAAP R&D spending increased 15% year-over-year.

不包括 Horizo​​n，非 GAAP 研發支出年增 15%。

The Horizon integration is progressing well, and we expect to reach the previously announced $500 million in pre-tax cost synergies by year three post-acquisition.

Horizo​​n 整合進展順利，我們預計收購後第三年將達到先前宣布的 5 億美元的稅前成本協同效應。

The acquisition was accretive to non-GAAP EPS for the full year 2024.

此次收購將增加 2024 年全年非公認會計準則每股收益。

Full year non-GAAP other income and expense was up $1.1 billion year-over-year, almost entirely due to increased interest expense from the Horizon acquisition.

全年非公認會計準則其他收入和支出年增 11 億美元，幾乎完全是由於收購 Horizo​​​​n 導致的利息支出增加。

We continue to strengthen our balance sheet with $4.5 billion of debt retired in 2024.

我們將於 2024 年償還 45 億美元的債務，從而繼續加強我們的資產負債表。

Our non-GAAP tax rate decreased 2 percentage points year-over-year to 14.5% for the full year primarily due to the change in earnings mix, including the addition of the Horizon business and net favorable items.

我們的非公認會計準則稅率年減 2 個百分點至全年 14.5%，這主要是由於收益結構的變化，包括增加了 Horizo​​n 業務和淨有利項目。

The company generated $10.4 billion in free cash flow for the full year and $4.4 billion in free cash flow in the fourth quarter.

該公司全年創造了104億美元的自由現金流，第四季創造了44億美元的自由現金流。

These results reflect strong momentum in the business and favorable timing of collections at year-end.

這些結果反映了業務的強勁勢頭和年底收款的有利時機。

We executed capital expenditures in 2024 of $1.3 billion, in line with the guidance provided.

我們按照提供的指導，在 2024 年執行了 13 億美元的資本支出。

With the cash outflow being $1.1 billion and the remainder to be paid in 2025.

現金流出為 11 億美元，剩餘部分將於 2025 年支付。

Our commitment to innovation is also evident as we deploy artificial intelligence across the value chain, including informing molecule design and discovery research, enabling faster trial enrollment and streamlining regulatory filings in clinical development, and enhancing our responsiveness to customers in commercial operations.

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，包括指導分子設計和發現研究，加快試驗登記和簡化臨床開發中的監管備案，並增強我們對商業營運中客戶的回應能力。

In addition, we returned capital to shareholders as we paid competitive dividends of $2.25 per share in the fourth quarter.

此外，我們在第四季度支付了每股 2.25 美元的有競爭力的股息，並向股東返還了資本。

This represented a 6% increase compared to 2023.

與 2023 年相比，這一數字增長了 6%。

We expect that we will continue to increase our dividend.

我們預計我們將繼續增加股利。

Let's turn to the outlook for the business for 2025 on slide 31.

讓我們來看看第 31 張投影片上的 2025 年業務展望。

We expect our 2025 total revenues in the range of $34.3 billion to $35.7 billion and non-GAAP earnings per share between $20 and $21.20. Our revenue range reflects our strong growth outlook driven by numerous opportunities across each of our therapeutic areas.

我們預計 2025 年總收入將在 343 億美元至 357 億美元之間，非 GAAP 每股收益將在 20 美元至 21.20 美元之間。我們的收入範圍反映了我們強勁的成長前景，這一前景受到各個治療領域的眾多機會的推動。

We expect continued growth across a number of products, led by our near-term growth drivers, Repatha, EVENITY, TEZSPIRE, our innovative oncology portfolio, our rare disease portfolio, and biosimilars.

我們預計多種產品將繼續成長，其中最主要的是我們的近期成長動力：Repatha、EVENITY、TEZSPIRE、我們的創新腫瘤學產品組合、我們的罕見疾病產品組合和生物相似藥。

This growth will more than offset declines due to the upcoming denosumab patent expiration as well as continued price declines across our portfolio in 2025.

這一增長將足以抵消因地舒單抗專利即將到期以及 2025 年我們整個產品組合價格持續下跌而造成的下滑。

For total company revenues, we expect each quarter of 2025 to have a relatively similar year-over-year growth rate.

對於公司總收入而言，我們預計 2025 年每季的年成長率將相對相似。

A reminder as you model the first quarter of 2025 and consistent with our historical trends, we expect Otezla and Enbrel to follow their typical pattern of lower sales in the first quarter relative to subsequent quarters.

提醒一下，當您模擬 2025 年第一季的情況並與我們的歷史趨勢一致時，我們預計 Otezla 和 Enbrel 將遵循其典型的模式，即第一季的銷售額相對於後續幾季有所下降。

Also note that biosimilar sales in the US can significantly vary quarter-to-quarter depending on customer ordering patterns.

還要注意的是，根據客戶的訂購模式，美國的生物相似藥銷售量每季可能會有很大差異。

For example, we expect Q1 AMJEVITA sales in the US to be in line with Q3 2024.

例如，我們預計美國第一季的 AMJEVITA 銷售額將與 2024 年第三季持平。

For the full year, we expect other revenue to be approximately $1.4 billion.

我們預計全年其他收入約為 14 億美元。

In 2025, we are driving R&D investments to support our promising late-stage pipeline, including MariTide and olpasiran.

2025 年，我們將加大研發投入，以支持我們前景看好的後期產品線，包括 MariTide 和 olpasiran。

As a result, we project the full year non-GAAP operating margin as a percentage of product sales to be roughly 46%.

因此，我們預期全年非 GAAP 營業利潤率佔產品銷售額的百分比約為 46%。

We project non-GAAP cost of sales to be in the range of 18% to 19% as a percentage of product sales for 2025.

我們預計，到 2025 年，非 GAAP 銷售成本佔產品銷售額的百分比將在 18% 至 19% 之間。

This projection reflects the ongoing impact of sales mix, including profit share and royalties.

這項預測反映了銷售組合（包括利潤份額和特許權使用費）的持續影響。

We expect non-GAAP R&D expense to grow year-over-year in the mid-teens in 2025 with investments increasing to advance key pipeline assets, including MariTide and olpasiran.

我們預計，到 2025 年，非 GAAP 研發費用將年增 15% 左右，投資將增加以推進關鍵的管道資產，包括 MariTide 和 olpasiran。

We see significant potential in our innovative pipeline, and it is important that we strategically invest now to fully unlock these opportunities.

我們看到我們的創新管道具有巨大的潛力，重要的是我們現在進行策略性投資以充分釋放這些機會。

And for the non-GAAP SG&A spend, we expect the 2025 full year amount as a percentage of product sales to decline by approximately 1 to 2 percentage points year-over-year as we continue to drive efficiencies and prioritize resources, including leveraging both automation and our newly established innovation and technology hub in India.

對於非 GAAP 銷售、一般及行政開支，我們預計 2025 年全年金額佔產品銷售額的百分比將同比下降約 1 至 2 個百分點，因為我們將繼續提高效率並優先利用資源，包括利用自動化和我們在印度新建立的創新和技術中心。

Overall, the operating margin of 46% indicates our commitment to investing in the best innovation while also driving execution excellence, efficiency and prioritization across the organization.

總體而言，46% 的營業利潤率表明我們致力於投資最佳創新，同時推動整個組織的卓越執行、效率和優先排序。

Consistent with prior years and in line with typical lower product sales in Q1, we expect Q1 non-GAAP operating margin to be the lowest of the year at roughly 42% and then accelerate in each of the quarters following the first quarter.

與往年一致，且符合第一季產品銷售額較低的典型情況，我們預計第一季非 GAAP 營業利潤率將是今年最低的，約為 42%，然後在第一季之後的每個季度都會加速。

We anticipate non-GAAP OI&E to be approximately $2.4 billion in 2025.

我們預計 2025 年非 GAAP OI&E 將達到約 24 億美元。

We expect a non-GAAP tax rate of 15% to 16%.

我們預計非公認會計準則稅率為 15% 至 16%。

Similar to 2024, we expect share repurchases not to exceed $500 million in 2025, and we expect the share count in the first quarter of 2025 to be flat to the fourth quarter of 2024.

與 2024 年類似，我們預計 2025 年的股票回購額不會超過 5 億美元，我們預計 2025 年第一季的股票數量將與 2024 年第四季持平。

We expect capital expenditures of approximately $2.3 billion in 2025.

我們預計 2025 年的資本支出約為 23 億美元。

This is consistent with our capital allocation priority to invest in our business and scale capacity for growth in marketed products and the pipeline.

這符合我們投資於業務和擴大市場產品和通路成長能力的資本配置優先事項。

We expect to maintain strong investment grade credit ratings as we continue to generate strong free cash flows, strengthen our balance sheet and remain on track to return to our pre-Horizon capital structure by the end of 2025.

我們預計將保持強勁的投資級信用評級，因為我們將繼續產生強勁的自由現金流，加強我們的資產負債表，並預計在 2025 年底前恢復到 Horizo​​n 之前的資本結構。

In 2025, we expect free cash flow performance to be similar to 2023.

到 2025 年，我們預計自由現金流表現將與 2023 年相似。

This decline is primarily driven by 2024 working capital favorability and incremental capital expenditures.

這一下降主要是受 2024 年營運資本有利性和增量資本支出的影響。

Free cash flow in the first half of 2025 will be impacted by strong 2024 year-end collections timing.

2025 年上半年的自由現金流將受到 2024 年底收款時機強勁的影響。

The shift in 2024 tax payments to the second quarter of 2025 and also the final $1.8 billion repatriation tax payment in the second quarter of 2025.

2024 年的稅款支付將轉移到 2025 年第二季度，最後的 18 億美元遣返稅款也將在 2025 年第二季支付。

Our long-term outlook remains strong, and I'm grateful to our colleagues worldwide for their dedication to serving patients.

我們的長期前景依然強勁，我感謝全球同事致力於服務患者。

This concludes our financial update.

我們的財務更新到此結束。

I'll now hand it back to Bob for our Q&A session.

現在我將把它交還給鮑勃，以便我們進行問答環節。

Okay.

好的。

Just to recap before we go to the Q&A session.

在我們進入問答環節之前，我們先回顧一下。

As you can see, our results highlight the breadth and depth of opportunities across our business.

如您所見，我們的業績凸顯了我們業務中機會的廣度和深度。

And we exited the fourth quarter with 10 products growing at double-digit sales rate and 14 products annualizing at over a $1 billion.

截至第四季度，我們有 10 種產品的銷售額達到兩位數成長，14 種產品的年銷售額超過 10 億美元。

And for the year, to repeat, we had 21 products delivering record sales.

今年，我們有 21 款產品的銷售量創下了歷史新高。

So this momentum supports our outlook for 2025 and through the long term.

因此，這種勢頭支持了我們對 2025 年及長期的展望。

And with that, we'd be happy to take questions.

因此，我們很樂意回答您的問題。

Julianne, if you could please remind our participants of the procedures here.

朱麗安，請你提醒我們的參與者這裡的程式。

(Operator Instructions) Yaron Werber, TD Cowen.

（操作員指示）Yaron Werber，TD Cowen。

Great.

偉大的。

Thanks for taking my question.

感謝您回答我的問題。

Maybe just a couple of things.

也許只是幾件事。

On AMG 513, the one that's on clinical hold for obesity, can you comment was that an incretin or non-incretin mechanism?

關於 AMG 513，即因肥胖症而臨床暫停使用的藥物，您能否評論一下它是一種腸促胰島素機制還是非腸促胰島素機制？

And then secondly, maybe just for Murdo.

其次，也許只是為了 Murdo。

A few things looked really strong.

有些事情看起來確實很強。

AMJEVITA was extremely strong at $294M.

AMJEVITA 表現極為強勁，達到 2.94 億美元。

Is that sustainable from now on?

從現在起這還能持續下去嗎？

What drove that?

是什麼導致了這現象？

Thank you.

謝謝。

All right.

好的。

We'll take it in two parts.

我們將分兩部分來討論。

Jay, do you want to address the AMG 513, I think it is.

傑伊，你想談談 AMG 513 嗎？

Thanks, Yaron.

謝謝，Yaron。

AMG 513 is a novel investigational medicine for patients with obesity.

AMG 513 是一種針對肥胖症患者的新型研究藥物。

It's currently in Phase 1 investigation.

目前正處於第一階段調查。

We have not disclosed the mechanism of action.

我們尚未揭示其作用機制。

This remains a competitive space, as you know.

如您所知，這仍然是一個競爭激烈的領域。

And Yaron, this is Murdo here.

亞隆，這是默多。

We're pleased with overall biosimilars performance.

我們對生物相似藥的整體表現感到滿意。

And our biosimilar portfolio, as I mentioned, last year grew about 16%, and we're confident we can continue to grow that portfolio going forward.

正如我所提到的，我們的生物相似藥產品組合去年增長了約 16%，我們相信我們可以繼續擴大該產品組合。

One of which of those growth contributors will be AMJEVITA.

這些成長貢獻者之一就是 AMJEVITA。

Great.

偉大的。

Julianne, we'll go to the next question.

朱麗安，我們進入下一個問題。

I will remind folks we have quite a full queue today.

我要提醒大家，今天我們的排隊人數已經很滿了。

So if you can limit yourself to one question, that would be great.

因此，如果你能將自己限制在一個問題上，那就太好了。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

Thanks for taking my question today.

感謝您今天回答我的問題。

I wanted to ask a little bit about Repatha.

我想問一些關於 Repatha 的問題。

Obviously, we've seeing kind of strong growth there and there's new indications coming, particularly in the primary prevention space.

顯然，我們看到了那裡強勁的成長，並且出現了新的跡象，特別是在初級預防領域。

Can you just talk a little bit about how you anticipate this market evolving as we think about the oral PCSK9s and Merck's CORALreef lipids trial that is also scheduled to read out later this year?

當我們考慮口服 PCSK9 和默克公司的 CORALreef 脂質試驗（也計劃於今年稍後公佈）時，您能否稍微談談您對這個市場發展的預測？

There seem to be suggestions that it could perform as well as an injectable in terms of the efficacy.

似乎有建議認為，就功效而言，它的效果與注射劑一樣好。

So just wanting to understand how you would position.

我只是想了解您的定位。

Thank you.

謝謝。

Yeah.

是的。

Thanks, Courtney.

謝謝，考特尼。

We're obviously very pleased with the performance of Repatha in 2024, putting up some very strong growth both in volume and in revenues, both in the US and outside of the United States.

我們顯然對 Repatha 在 2024 年的表現非常滿意，無論是在美國還是美國以外，其銷售和收入都實現了非常強勁的成長。

And we expect to see that continue.

我們期望這種情況能夠持續下去。

We expect to be able to treat the many patients who have not had their LDL cholesterol optimized, and there's millions upon millions of these patients.

我們希望能夠治療眾多尚未優化 LDL 膽固醇水平的患者，這樣的患者有數以百萬計。

We are barely scratching the surface when it comes to treating them.

我們對它們的治療只是剛開始。

And we think that Repatha offers a really ideal solution for patients to receive it and for prescribers to prescribe it.

我們認為 Repatha 為患者接受治療和處方醫生開處方提供了真正理想的解決方案。

What we're really pleased about is the perception amongst prescribers now that Repatha is an easy-to-access medicine and an affordable medicine, and that's thanks to the efforts of our access teams around the world making sure that Repatha is appropriately reimbursed and positioned on formularies with PBMs.

我們真正高興的是，現在處方人員認為 Repatha 是一種易於獲取且價格合理的藥物，這要歸功於我們在世界各地的獲取團隊的努力，他們確保 Repatha 得到適當的報銷並被納入 PBM 的處方集。

And we've been successful in removing those barriers.

我們已成功消除這些障礙。

So we really are at an inflection point in Repatha's performance and feel very, very good about the trajectory and momentum we established in 2024.

因此，我們確實正處於 Repatha 業績的轉折點，並且對我們在 2024 年確定的發展軌跡和勢頭感到非常非常滿意。

With respect to new competition, obviously, there's more than just LDL cholesterol-lowering evidence that needs to be introduced here.

對於新的競爭，顯然，這裡需要引入的不僅僅是降低 LDL 膽固醇的證據。

Repatha has clearly demonstrated benefit in secondary prevention of heart attacks, strokes and other cardiovascular sequelae.

Repatha 在心臟病發作、中風和其他心血管後遺症的二級預防中表現出了明顯的益處。

And the goal, of course, as you mentioned is that with VESALIUS, which reads out later this year, that we'll be able to show that you can actually lower the risk of a first heart attack or stroke or other cardiovascular event.

當然，正如您所說，我們的目標是透過今年稍後公佈的 VESALIUS，證明確實可以降低首次心臟病發作、中風或其他心血管事件的風險。

So we're kind of -- we're in the mode of helping treat hard endpoints now in this market and not just lowering LDL.

因此，我們現在處於幫助治療這個市場上的硬終點的模式，而不僅僅是降低 LDL。

So we'll see what the evidence is and how it accumulates with not just the orals, but other competitors that are trying to come into this market.

因此，我們將看看證據是什麼，以及它是如何累積的，不僅是口服藥，還有其他試圖進入這個市場的競爭對手。

But again, obviously, Repatha is a very important growth driver for us now and into the future.

但顯然，Repatha 對於我們現在和未來來說都是一個非常重要的成長動力。

Alright.

好吧。

Julianne, take the next question please.

朱麗安，請回答下一個問題。

Salveen Richter, Goldman Sachs.

高盛的薩爾文·里希特（Salveen Richter）。

Good afternoon.

午安.

Thanks for taking my question.

感謝您回答我的問題。

In the context of your 2025 sales guidance, can you speak to where you feel The Street is underappreciating growth and discuss how you factored in the Part D redesign to your projections?

在您 2025 年銷售指導的背景下，您能否談談華爾街在哪些方面低估了成長，並討論您是如何將 D 部分的重新設計納入您的預測的？

Thank you.

謝謝。

Let me take it in two pieces.

讓我把它分成兩個部分。

Murdo, why don't you first start on the Part D redesign and then, Pete, why don't you jump in?

Murdo，為什麼不先開始重新設計 D 部分，然後，Pete，為什麼不加入進來呢？

Yeah.

是的。

The Part D redesign at a total portfolio level for us is relatively neutral between some of the products we have that would be impacted by catastrophic coverage versus some of the products that we have are more chronic care products that benefit from no longer having a donut hole.

對我們來說，在整體投資組合層面上對 D 部分進行重新設計是相對中性的，因為我們擁有的一些產品會受到災難性保險的影響，而我們的一些產品則是更多的慢性護理產品，這些產品不再存在甜甜圈洞。

So, the puts and takes of that put us in a relatively neutral impact from Part D redesign at a total portfolio level.

因此，從整體投資組合層面來看，D 部分重新設計對我們的影響相對中性。

That being said, obviously, products like Repatha will benefit given that chronic care cardiovascular products at an affordable price like Repatha tend to do well when patients' out of pocket is capped and smoothed.

話雖如此，但顯然，像 Repatha 這樣的產品將從中受益，因為當患者的自付費用受到限制和平滑時，像 Repatha 這樣的實惠的慢性護理心血管產品往往會表現良好。

And that's what we believe will happen for products like Repatha going forward.

我們相信，未來 Repatha 等產品也將實現這樣的發展。

Peter?

彼得？

Great.

偉大的。

Murdo, thank you.

默多，謝謝你。

Salveen, thank you for the question.

Salveen，謝謝你的提問。

I would just remind you what we've said, which is, let's start from 10 products with double-digit growth in 2024 over 2023, 14 products annualizing at blockbuster status of $1 billion or more and 21 that were records in 2024.

我只是想提醒大家我們已經說過的話，那就是，讓我們從 10 種到 2024 年將比 2023 年實現兩位數增長的產品開始，14 種產品的年化收入將達到 10 億美元或以上，21 種產品的年化收入將創下紀錄。

So strong in-market portfolio, Salveen.

Salveen 的市場投資組合非常強大。

So when we look at 2025, I'd really like to start with two, and then add four more on to think about.

因此，當我們展望 2025 年時，我真的希望從兩個開始，然後再考慮四個。

Murdo talked about Repatha.

Murdo 談到了 Repatha。

So as he said, 100 million people around the world needing treatment.

正如他所說，全世界有 1 億人需要治療。

VESALIUS is coming later this year and less price erosion, maybe mid-single digit or less this year on that.

VESALIUS 將於今年稍晚上市，價格下滑幅度較小，今年可能為個位數中段甚至更低。

He talked about the strong access globally.

他談到了全球強大的訪問能力。

So we expect Repatha to continue to be a strong medicine going forward.

因此，我們預期 Repatha 將在未來繼續成為一種強效藥物。

And the second on EVENITY.

第二篇是關於 EVENITY。

It's got low single-digit penetration.

其滲透率僅為個位數。

Greater than 90% of the high-risk patients in the US haven't been treated.

美國超過90％的高風險患者尚未接受治療。

And there's a significant unmet need there with EVENITY.

EVENITY 也存在大量未滿足的需求。

So we think those two are very, very important.

因此我們認為這兩者非常非常重要。

But let me also share TEZSPIRE, up 71% in 2024 to almost $1 billion.

但我也要分享 TEZSPIRE，到 2024 年它將上漲 71%，達到近 10 億美元。

I think it was $972 million of product sales.

我認為產品銷售額是 9.72 億美元。

Innovative oncology, up 11%, the seven innovative oncology products we have in 2024.

創新腫瘤學，成長 11%，到 2024 年我們將擁有 7 種創新腫瘤學產品。

We think that's a very strong portfolio to help patients with oncology and hematology disease.

我們認為這是一個非常強大的產品組合，可以幫助腫瘤和血液疾病患者。

Rare disease, up to about $4.5 billion in 2024.

罕見疾病，到 2024 年將達到約 45 億美元。

And reminder, these are early life-cycle products and so they've got ways to go.

提醒一下，這些都是早期生命週期的產品，所以它們還有很長的路要走。

And when we think about those four, we see a lot of growth there and a lot of opportunity.

當我們思考這四個面向時，我們看到了很多成長空間和很多機會。

But then we get to biosimilars.

但後來我們談到了生物相似藥。

We shared with you 16% growth up to about $2.2 billion in 2024.

我們與您分享了 16% 的成長率，到 2024 年將達到約 22 億美元。

We've got some launches coming this year.

我們今年將會推出一些產品。

And so, we continue to see a lot of growth in that.

因此，我們繼續看到這方面的大幅成長。

So we think there's a lot of opportunity to continue to grow this business in a strong way in 2025 and going forward.

因此，我們認為，2025 年及以後，該業務仍有很大機會持續強勁成長。

And as I shared in my opening remarks, we see that driving us right past the expiry on denosumab.

正如我在開場白中所說的那樣，我們看到這將使我們剛好度過地舒單抗的到期日。

So I'll leave it there, but we're very pleased with the business.

所以我就不多說了，我們對業務非常滿意。

And most importantly, we expect more medicine to more patients in 2025 around the world.

最重要的是，我們預計到 2025 年，全球將有更多藥物供應給更多患者。

All right.

好的。

Julianne let's go to the next question, please.

朱麗安，請我們進入下一個問題。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks.

謝謝。

So wanted to switch gears and get your thoughts on some of the Horizon products.

因此想換個話題，聽聽您對一些 Horizo​​n 產品的看法。

KRYSTEXXA, how are you thinking about the growth runway there and the potential for biosimilar down the road?

KRYSTEXXA，您如何看待那裡的成長空間以及未來生物相似藥的潛力？

And then also how you're thinking about the competitive landscape for TEPEZZA?

那麼您如何看待 TEPEZZA 的競爭格局？

Thanks.

謝謝。

Sure.

當然。

Murdo, do you want to jump in?

默多，你想跳進去嗎？

Thank you, David.

謝謝你，大衛。

KRYSTEXXA had a very strong year in growth, year-over-year.

KRYSTEXXA 今年的年成長非常強勁。

When we look at, if we include the Horizon performance from the prior period, KRYSTEXXA was up 23%; UPLIZNA, up 40%; TAVNEOS, up 111%; and TEPEZZA, up 5%.

我們來看，如果包括前一期的 Horizo​​​​n 表現，KRYSTEXXA 上漲了 23%； UPLIZNA，上漲40%； TAVNEOS，上漲111%； TEPEZZA 上漲 5%。

So this is, as Peter mentioned, overall, it's a portfolio of products very early on in their life cycle with more data to flow as is the case, of course, with UPLIZNA with our IgG4 data and additional gMG data coming on 52 weeks.

因此，正如 Peter 所提到的，總的來說，這是一個處於生命週期早期的產品組合，擁有更多的數據流，當然，UPLIZNA 的情況就是如此，我們擁有 IgG4 數據和 52 週後的額外 gMG 數據。

So we have a number of catalysts that will grow our business in the US, and then we have catalysts for growth outside the US with, of course, international launches and expansion, which is well underway with the recent approval of TEPEZZA in Japan.

因此，我們有許多催化劑可以促進我們在美國的業務成長，然後我們也有催化劑可以促進美國以外的業務成長，當然，還有國際發布和擴張，隨著 TEPEZZA 在日本的最近批准，這項工作正在順利進行中。

With respect to KRYSTEXXA overall, again, even though KRYSTEXXA is part of our rare disease portfolio, severe uncontrolled gout is not a rare disease.

就 KRYSTEXXA 整體而言，儘管 KRYSTEXXA 是我們罕見疾病產品組合的一部分，但嚴重的不受控制的痛風並不是一種罕見疾病。

It's not a rare condition.

這並不是一種罕見的情況。

There are lots of patients out there who suffer continuously.

有很多患者正在持續遭受痛苦。

And with the immunomodulation data, we are now able to help many of those patients.

利用免疫調節數據，我們現在能夠幫助許多患者。

And so, we see continued robust opportunity for growth there.

因此，我們看到那裡持續強勁的成長機會。

And we're also looking to develop additional pipeline assets.

我們還希望開發額外的管道資產。

And so, Jay and his team are looking at those opportunities.

因此，傑伊和他的團隊正在尋找這些機會。

Michael Yee, Jefferies.

傑富瑞 (Jefferies) 的麥可餘 (Michael Yee)。

Hey, guys.

嘿，大家好。

Thanks for the question.

謝謝你的提問。

Other than MariTide, you've had one or two obesity assets have some slip-ups.

除了 MariTide 之外，還有一兩種肥胖資產出現了一些失誤。

Can you maybe comment about your strategic view about where you'd like to be in a couple of years, if you are so confident on MariTide, given that everyone's chasing a multiple asset portfolio, including orals?

如果您對 MariTide 如此有信心，考慮到每個人都在追求多種資產投資組合，包括口服藥物，您能否評論一下您對未來幾年的戰略看法？

And you seem to be pretty early stage outside of MariTide.

而你們在 MariTide 之外似乎還處於早期階段。

So maybe just comment about your appetite there and whether you can add to the portfolio.

因此也許只是評論一下您的興趣以及是否可以添加到作品集中。

Thank you.

謝謝。

Sure.

當然。

Mike, I'm not sure we accept the premise.

麥克，我不確定我們是否接受這個前提。

But anyway, let's talk about the portfolio of obesity programs.

但無論如何，讓我們來談談肥胖計畫的組合。

Go ahead, Jay?

繼續吧，傑伊？

Thanks, Mike.

謝謝，麥克。

Akin to what Bob said, I wouldn't call these slip-ups at all.

正如鮑勃所說的那樣，我根本不會將這些稱為失誤。

Early phase clinical investigation here at Amgen has a really high bar for what medicines go forward, and the next medicine up after MariTide did not meet that bar.

安進公司早期臨床研究對於藥物的進展設定了非常高的標準，而 MariTide 之後的下一個藥物並未達到這個標準。

Our obesity efforts fit very well with our strength in cardiovascular disease, nephrology, and more generally, the emerging presence in primary care.

我們在肥胖症治療方面的努力與我們在心血管疾病、腎臟病學以及更廣泛的初級保健領域中的優勢非常契合。

And so, we're very confident that we have all the talent capabilities, ideas and rising medicines to be a major player in obesity for the fullness of time, which we've studied for more than a decade.

因此，我們非常有信心，我們擁有所有的人才能力、創意和新興藥物，能夠在很長一段時間內成為肥胖症領域的主要參與者，而我們對肥胖症的研究已經超過十年了。

The research and early development pipeline has ideas targeting incretins, also non-incretins.

研究和早期開發管道有針對腸促胰島素和非腸促胰島素的想法。

We have medicines that will be given orally, others by subcutaneous administration.

我們有些藥物是口服的，有些是皮下注射的。

We're also interested to open partnerships through external innovation.

我們也對透過外部創新建立合作夥伴關係感興趣。

And so we're very confident in MariTide and very confident in the pipeline behind it.

因此，我們對 MariTide 非常有信心，並且對其背後的管道也非常有信心。

Sorry, Jay, just to clarify one thing.

抱歉，傑伊，我只是想澄清一件事。

The AMG 513 is still -- we still expect to have that development.

AMG 513 仍然——我們仍然期待有這樣的發展。

We don't believe the issue that we referenced is related to the drug, but we'll go through the usual steps with the regulators on that.

我們不認為我們所提到的問題與藥物有關，但我們將與監管機構一起採取通常的措施。

But Jay was referring to another product that we're no longer advancing that was previously in the clinic.

但傑伊指的是另一種我們不再推廣的、先前已在臨床上使用的產品。

So when he said it didn't pass the hurdle.

所以當他說這沒有過關的時候。

But again, we're excited about the program and the molecules that are coming forward to the clinic out of the obesity portfolio.

但是，我們再次對該計劃以及在肥胖症治療領域進入臨床的分子感到非常興奮。

Jay Olson, Oppenheimer.

傑伊奧爾森、奧本海默。

(technical difficulty)

（技術難度）

Jay, sorry, we can't hear you.

傑伊，抱歉，我們聽不到你的聲音。

Take another start.

重新開始。

Okay.

好的。

Could you describe the key lessons you expect to learn from the Repatha, VESALIUS-CV outcome study results, how you can leverage those lessons across your portfolio, including olpasiran and MariTide?

您能否描述一下您希望從 Repatha、VESALIUS-CV 結果研究結果中吸取的主要教訓，以及如何在您的產品組合（包括 olpasiran 和 MariTide）中利用這些教訓？

And any synergies you plan to capture across these programs?

您計劃在這些項目之間實現什麼協同效應？

Thank you.

謝謝。

Sure.

當然。

Jay?

傑伊？

Sure.

當然。

Why don't I start and then Murdo, I invite you to speak to synergies and the like.

我先開始吧，然後是 Murdo，我邀請你談談綜效之類的議題。

We've learned a lot from Repatha already.

我們已經從 Repatha 學到了很多。

We have a leading capability in population genetics and epidemiology.

我們在群體遺傳學和流行病學方面擁有領先的能力。

And now the broad use of Repatha in secondary prevention is a fantastic setup for VESALIUS-CV.

現在 Repatha 在二級預防中的廣泛使用對 VESALIUS-CV 來說是一個極好的設定。

As you know, this is a Phase 3 large cardiovascular outcome study of more than 12,000 patients, placebo-controlled, patients at high cardiovascular risk without prior MI or stroke.

如您所知，這是一項 3 期大型心血管結果研究，研究對象為 12,000 多名患者，採用安慰劑對照，這些患者俱有較高的心血管風險，且之前沒有發生過心肌梗塞或中風。

This is ongoing.

此舉仍在進行中。

We have an event-driven readout expected in the second half of this year.

我們預計今年下半年會有一個事件驅動的讀數。

This will be a large and valuable data set for us to mine to understand the further improvement of cardiovascular outcomes for patients as it relates to LDL-C, but also for other parameters.

這將是一個龐大且有價值的數據集，我們可以挖掘它來了解與 LDL-C 以及其他參數相關的患者心血管結果的進一步改善。

We have already harvested so many insights from Repatha and carried that into the design and execution of the olpasiran Phase 3 program, which as you heard, it has an event-driven outcome, expected a readout in the second half of next year.

我們已經從 Repatha 中收穫了許多見解，並將其運用到 olpasiran 第三階段計劃的設計和執行中，正如您所聽到的，它有一個事件驅動的結果，預計明年下半年會公佈結果。

So very valuable data set that will no doubt prompt significant further insights.

因此非常有價值的數據集無疑將帶來進一步的重要見解。

Thanks, Jay.

謝謝，傑伊。

The synergies here are significant and substantial given the leadership presence we have in LDL lowering and being able to apply that to Lp(a) lowering with olpasiran obviously if successful in the readout of our Phase 3 trial.

鑑於我們在降低 LDL 領域的領導地位，這裡的協同作用是重大而實質性的，並且能夠將其應用於使用奧帕西蘭降低 Lp(a)，如果我們在第 3 階段試驗的讀數中取得成功，這一點顯然是顯而易見的。

I do think there's going to be some differences, though, given that Lp(a) cannot be modified by lifestyle, diet and exercise.

不過，我確實認為會存在一些差異，因為 Lp(a) 無法透過生活方式、飲食和運動來改變。

There are no other generically available or branded available products that can lower Lp(a).

目前尚無其他通用或品牌產品可降低 Lp(a)。

We do think that the intentionality and the speed to move to a pharmacotherapeutic for Lp(a) lowering will be different than it has been for LDL.

我們確實認為，轉向降低 Lp(a) 的藥物治療的目的性和速度與降低 LDL 的藥物治療有所不同。

But nonetheless, we're clearly engaged with all of the different stakeholders in the lipid lowering and atherosclerotic market, and we're engaging them as appropriate to make sure that they understand the profile of olpasiran and the design of the trial that Jay mentioned and ultimately when we have results to share.

但儘管如此，我們顯然與降脂和動脈粥樣硬化市場的所有不同利益相關者進行了接觸，並在適當的時候與他們接觸，以確保他們了解奧帕西崙的概況和傑伊提到的試驗設計，並最終了解我們可以分享的結果。

Alex Hammond, Wolfe Research.

亞歷克斯‧哈蒙德，沃爾夫研究公司。

Thanks for taking the question.

感謝您回答這個問題。

So with more and more companies looking to China for innovation, what is Amgen's stance on looking overseas for clinical-stage assets?

那麼，隨著越來越多的公司將目光投向中國進行創新，安進對於在海外尋找臨床階段資產的立場是什麼？

And I guess more broadly, what is your appetite for M&A now post the Horizon acquisition?

我想更廣泛地說，在收購 Horizo​​​​n 之後，您對併購的興趣如何？

Thank you.

謝謝。

Our position on business development remains pretty consistent, Alex.

亞歷克斯，我們對業務發展的立場仍然非常一致。

We're focused on molecules that we think we can add value to irrespective of where they come from.

我們專注於那些我們認為可以增加價值的分子，無論它們來自哪裡。

So we have had and maintained a very active search for interesting opportunities for licensing and acquisitions all around the globe.

因此，我們一直積極地在全球範圍內尋找有趣的授權和收購機會。

And yeah, we're open for business, looking for those opportunities.

是的，我們已經開始營業，正在尋找這些機會。

Terence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林 (Terence Flynn)。

Hi.

你好。

Thanks so much for the question.

非常感謝您提問。

Also just wanted to say my thoughts with all those Amgen employees and everyone in the LA area who's been impacted by the devastating wildfires.

我也想向所有安進員工以及洛杉磯地區受到毀滅性野火影響的人們表達我的想法。

I had a two parter on MariTide.

我在 MariTide 上有兩個部分。

I know you're doing Part 2.

我知道你正在做第二部分。

The Phase 2 explored quarterly dosing.

第 2 階段探討了每季給藥。

Just wondering if there's an interim look there so you can incorporate that schedule into the Phase 3 program if you decide to.

只是想知道是否有一個臨時的觀察，以便您可以將該計劃納入第 3 階段計劃（如果您決定的話）。

And then I was wondering if you can tell us if ADA is a fair assumption for presentation of the full MariTide Phase 2 obesity data.

然後我想知道您是否可以告訴我們 ADA 是否是呈現完整的 MariTide 第 2 階段肥胖數據的合理假設。

Thank you.

謝謝。

Sure.

當然。

Jay?

傑伊？

Yeah.

是的。

Thanks, Terence, for your question and really appreciate the call-out for the associates here and the area residents facing these fires.

謝謝特倫斯提出的問題，我們非常感謝您對這裡的同事和麵臨火災的當地居民的關注。

We have, as you know, an ongoing Part 2 of our Phase 2 study in chronic weight management.

如您所知，我們正在進行慢性體重管理第二階段研究的第二部分。

That is a 52-week study, and we expect data readout late this year.

這是一項為期 52 週的研究，我們預計今年稍後會讀取數據。

I can confirm that we look forward to presenting the Phase 2 Part 1 data at the ADA meeting in June this year in Chicago and look forward to seeing you there.

我可以確認，我們期待在今年 6 月在芝加哥舉行的 ADA 會議上展示第 2 階段第 1 部分的數據，並期待在那裡見到您。

Dave Risinger, Leerink Partners.

Dave Risinger，Leerink Partners。

Yeah.

是的。

Thanks very much.

非常感謝。

So I have a simple question.

我有一個簡單的問題。

Clearly, you've provided a lot of helpful pipeline updates on the call.

顯然，您在通話中提供了許多有用的管道更新。

So thank you for that.

非常感謝你。

So my question, Jay, is could you just explain why you're announcing today the plans to initiate a new olpasiran Phase 3 trial in high-risk patients when it's not going to be initiated until late '25 or early '26?

所以我的問題是，傑伊，你能否解釋一下為什麼你今天宣布計劃在高風險患者中啟動一項新的奧帕西崙 3 期試驗，而這項試驗要到 25 年末或 26 年初才會啟動？

What is pending initiating that trial?

啟動該審判還有什麼需要等待？

Thank you.

謝謝。

Again, Dave, maybe I can just clarify.

再說一次，戴夫，也許我可以澄清一下。

I mentioned this in January at JPM in the context -- it's Bob speaking, Dave, in the context of what to expect for the year.

我在今年 1 月的 JPM 會議上提到過這一點——這是鮑勃戴夫在談論對今年的預期時說的。

But Jay, go ahead and address the specific piece of the question, if you like.

但是傑伊，如果你願意的話，請繼續回答問題的具體部分。

Yeah.

是的。

No, nothing more to add.

不，沒什麼好補充的了。

We have already announced our intention to initiate a Phase 3 clinical investigation of olpasiran in primary prevention.

我們已經宣布了啟動奧帕西崙在第一級預防中應用的 3 期臨床研究的意向。

This is a strong hypothesis for protecting patients with elevations of Lp(a).

這是保護 Lp(a) 升高患者的有力假設。

We hope to initiate this study -- intend to initiate this study in the second half of this year or in the first half of next year.

我們希望啟動這項研究——打算在今年下半年或明年上半年啟動這項研究。

We just have a total commitment to the benefit of patients facing -- in this case, genetically defined risk of cardiovascular disease.

我們全心全意地致力於為面臨基因定義的心血管疾病風險的患者謀福利。

Chris Schott, JPMorgan.

摩根大通的克里斯·肖特 (Chris Schott)。

Great, thanks so much.

太好了，非常感謝。

Just wanted to talk through TEPEZZA and just how we should be thinking about growth in the US and internationally here?

只是想透過 TEPEZZA 談談我們應該如何考慮美國和國際上的發展？

I guess specifically, can you talk about ex-US, the Japan opportunity and some of these new markets?

我想具體地說，您能談談美國以外、日本的機會和一些新市場嗎？

And can we think about the rapid ramp that we saw in the US kind of repeating itself in those markets?

我們是否可以想像美國市場出現的快速成長也會在這些市場重演？

Or are these more gradual ramps as these roll out?

或者說，隨著這些措施的推出，這些進程將呈現更漸進的上升趨勢？

Thank you.

謝謝。

Yeah.

是的。

Hi, Chris, it's Murdo here.

你好，克里斯，我是默多。

Thanks for the question on TEPEZZA.

感謝您關於 TEPEZZA 的提問。

In Japan, the epidemiology is quite significant here, roughly 25,000 patients what we're talking about.

在日本，流行病學的情況相當嚴重，約有 25,000 名患者。

The care model in Japan does reduce the friction that prescribers and patients experience in terms of finding access to the right physician and then access to a site of care.

日本的護理模式確實減少了開藥者和患者在尋找合適的醫生以及前往護理機構方面所遇到的摩擦。

So we do expect there to be a pretty good uptake in this market.

因此我們確實預期這個市場將會有相當好的成長。

Not sure about the bolus dynamic that we saw in the United States that did have some impact because it was a launch during the COVID period.

我不確定我們在美國看到的 Bolus 動態是否確實產生了一些影響，因為它是在 COVID 期間推出的。

So I'm not sure I would compare curves there.

所以我不確定我是否會比較那裡的曲線。

But I would expect steady penetration of the Japanese patient population.

但我預計日本患者群體的滲透率將穩定提高。

We know there have been over 550 patients already identified by prescribers.

我們知道，已有超過 550 名患者被醫生確診。

I was there for the launch at the end of last year.

去年年底我參加了這場發表會。

The weekly data are showing some pretty good steady momentum.

每週數據顯示了相當良好的穩定動能。

And so, Japan will be a very good source of growth for TEPEZZA internationally.

因此，日本將成為 TEPEZZA 國際業務的良好成長源。

As I mentioned, we've got seven other markets that we'll be launching in, hopefully, this year, pending regulatory approvals.

正如我所提到的，我們也將在其他七個市場推出產品，希望能夠在今年獲得監管部門的批准。

And we do see that international catalyst -- international growth as a catalyst for the overall brand.

我們確實看到了國際催化劑——國際成長是整個品牌的催化劑。

And it's obviously one of the things that drove the acquisition, the ability for Amgen's global footprint to bring these medicines to more patients.

這顯然是推動此次收購的因素之一，即安進的全球影響力能夠將這些藥物帶給更多的患者。

In the US, we continue to focus on broadening the prescriber base for TEPEZZA.

在美國，我們繼續致力於擴大 TEPEZZA 的處方基礎。

So helping general ophthalmology and endocrinology diagnose, not just the Graves' disease but also the thyroid eye disease and then find a site of care for patients to receive as a treatment.

因此，幫助普通眼科和內分泌科診斷不僅是格雷夫茲病，還有甲狀腺眼疾，然後為患者找到治療的護理場所。

Just one overarching comment I'll make on TEPEZZA, it does follow the pattern we see in some other products in our portfolio where that first quarter this year will be a little bit lower than the other three quarters, mostly a function of people having their insurance reverified and or purchasing patterns in the market.

我對 TEPEZZA 只想發表一個總體評論，它確實遵循了我們投資組合中其他一些產品的模式，今年第一季的業績將略低於其他三個季度，這主要是由於人們對保險進行了重新驗證和/或在市場上購買的模式。

So just something to watch out for.

所以這只是需要注意的事情。

But long term, TEPEZZA growth is looking very good given the international approvals and the momentum that we plan to generate in the US.

但從長遠來看，考慮到國際認可以及我們計劃在美國產生的勢頭，TEPEZZA 的成長前景非常好。

James Shin, Deutsche Bank.

德意志銀行的詹姆斯辛 (James Shin)。

Hey guys, thank you for taking my question.

嘿夥計們，謝謝你們回答我的問題。

Any color on the indications for the MARITIME trials that will start in the first half of '25?

關於將於 25 年上半年開始的海事試驗，有什麼跡象嗎？

And can you say anything on whether or not MARITIME will have head-to-head against incumbents such as tirzepatide or semaglutide at this point?

您能否透露一下 MARITIME 目前是否會與 tirzepatide 或 semaglutide 等現有企業展開正面交鋒？

Thank you.

謝謝。

Yeah.

是的。

Thank you, James.

謝謝你，詹姆斯。

The MARITIME Phase 3 program has a focus on chronic weight management, on cardiovascular disease, kidney disease, type 2 diabetes, sleep apnea, heart failure and possibly additional indications.

MARITIME 第三階段計畫的重點是慢性體重管理、心血管疾病、腎臟疾病、第 2 型糖尿病、睡眠呼吸中止症、心臟衰竭以及可能的其他適應症。

As our discussions are at a rather mature state with the federal regulators, it would be premature to talk through any design principles around these trials at this time, but we look very much forward to initiating the MARITIME Phase 3 program.

由於我們與聯邦監管機構的討論已經相當成熟，目前討論這些試驗的任何設計原則還為時過早，但我們非常期待啟動 MARITIME 第三階段計劃。

Tim Anderson, Bank of America.

美國銀行的蒂姆·安德森。

Thank you.

謝謝。

I know Amgen commonly says it doesn't get enough credit side of The Street for its biosimilar business, so I'd like to ask about that.

我知道安進公司普遍表示其生物相似藥業務沒有獲得華爾街足夠的認可，所以我想問一下這個問題。

And just one product in particular, PAVBLU, the EYLEA biosimilar, why can't that be a very significant product for you guys as the only seller into that large market right for the next few years?

特別是 PAVBLU 這種 EYLEA 生物相似藥，作為未來幾年內這個龐大市場的唯一賣家，為什麼它不能成為你們非常重要的產品呢？

It seems like it could get to a $1 billion-plus type sales level.

看起來它的銷售額可以達到 10 億美元以上。

And can you give us some idea of what's in your 2025 guide for this?

您能向我們介紹一下 2025 年指南中對此有何規定嗎？

Thank you.

謝謝。

Okay.

好的。

Tim, we couldn't hear very clearly the beginning of your question, but it seems that you're asking about biosimilars.

提姆，我們聽不清楚你的問題的開頭，但看起來你問的是生物相似藥。

Perhaps you suggested we don't get enough credit for what we do in biosimilars if that's what you said, we're grateful.

也許您認為我們在生物相似藥領域所取得的成就沒有得到足夠的認可，如果您這麼說，我們非常感激。

We are world leaders, as you know, in biosimilars and our focus has been to reliably supply biosimilars when we're appropriately able to enter the market and our objective is to be amongst the first wave of biosimilar entrants, and that's what we've achieved with PAVBLU.

如您所知，我們是生物相似藥領域的全球領導者，我們的重點是當我們能夠適當進入市場時可靠地供應生物仿製藥，我們的目標是成為第一批生物仿製藥進入者之一，這就是我們透過 PAVBLU 所實現的目標。

But as to the specifics, Murdo, do you want to address Tim's questions?

但至於具體細節，Murdo，你想回答提姆的問題嗎？

Yeah.

是的。

Tim, as you know, we don't give product-specific guidance.

提姆，如你所知，我們不提供針對特定產品的指導。

But given your comments, I would say we're very pleased with how the launch is going.

但根據您的評論，我想說我們對發布的進展非常滿意。

As Bob mentioned, always try to target being in the first wave.

正如鮑勃提到的那樣，總是努力瞄準第一波。

We find ourselves being the only biosimilar available in the market right now.

我們發現我們是目前市場上唯一可用的生物相似藥。

And of course, that represents an opportunity that we will capitalize on.

當然，這代表著我們將要利用的一個機會。

The current feedback from retina specialists that we've been talking to is very enthusiastic, very positive.

目前，我們與視網膜專家交流後所得到的回饋非常熱情、非常正面。

They are pleased that Amgen is bringing yet another high-quality biosimilar in a very easy-to-use prefilled syringe.

他們很高興安進公司推出了另一種採用非常易於使用的預充式註射器的高品質生物相似藥。

Given the number of administrations these retina specialists do each and every day, that device is quite important.

考慮到這些視網膜專家每天進行的管理次數，該設備非常重要。

And thanks to our legal colleagues and our manufacturing operations and process development teams, they've done a very, very nice job of making sure that we have a path to helping many more patients with another Amgen biosimilar.

感謝我們的法律同事以及我們的製造營運和流程開發團隊，他們做得非常出色，確保我們能夠使用另一種安進生物相似藥來幫助更多患者。

Maybe to add on just a little bit, Murdo and Bob, I would suggest, Tim, we build what we think obviously is an industry-leading biosimilar franchise.

也許只是稍微補充一下，Murdo 和 Bob，我建議，Tim，我們建立我們認為顯然是行業領先的生物仿製藥特許經營權。

We operate very efficiently.

我們的運作非常有效率。

We leverage the broader Amgen footprint, including manufacturing and operations.

我們利用安進更廣泛的業務範圍，包括製造和營運。

We believe we're earning attractive returns for our shareholders in this.

我們相信我們將透過此舉為股東帶來豐厚的回報。

When we pursue an opportunity, we deliver to date.

當我們尋求機會時，我們會及時兌現。

I would remind you that we have a 100% success rate of FDA approval once we enter the clinic.

我要提醒大家的是，一旦我們進入臨床，FDA 核准的成功率是 100%。

And with $10 billion in cumulative biosimilar sales through '24, we're on track to double 2021 sales to over $4 billion by the end of the decade.

截至2024年，生物相似藥的累計銷售額已達到100億美元，預計到2020年，我們的銷售額將翻倍，達到40億美元以上。

I think that reinforces our leadership and ability to deliver attractive returns.

我認為這增強了我們的領導地位和提供可觀回報的能力。

So it's a really important question.

所以這是一個非常重要的問題。

We're delighted and we think this is a good use of shareholder capital.

我們很高興，我們認為這是對股東資本的良好利用。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

Hi there, this is Conor MacKay on for Evan.

大家好，我是 Conor MacKay，代表 Evan 報道。

Thanks for taking our question and congrats on the quarter.

感謝您回答我們的問題，並祝賀本季取得的成績。

We just had one question on the Phase 3 ROCKET program.

我們對第三階段 ROCKET 計劃只有一個問題。

With several readouts coming over the balance of the year, what are you looking to see from those readouts to get comfortable with your competitive positioning in the atopic dermatitis market?

今年將會有幾份讀數出來，您希望從這些讀數中看到什麼，以便確定您在異位性皮膚炎市場的競爭定位？

And any updated thoughts on how you're thinking about that?

您對此有什麼最新的看法嗎？

Thank you.

謝謝。

Thanks for the question.

謝謝你的提問。

Rocatinlimab, our T-cell rebalancing monoclonal antibody targets the OX40 receptor.

Rocatinlimab 是我們的 T 細胞再平衡單株抗體，靶向 OX40 受體。

As you note, is -- we are reading out this year a number of studies of this ROCKET program.

正如您所注意到的，我們今年正在宣讀一些有關 ROCKET 計劃的研究報告。

This eight study, more than 3,300 patient program, really gives a lot of granularity, to answer your question, around the target product profile, the safety and tolerability of Rocatinlimab and its full efficacy in patients with atopic dermatitis in the SHUTTLE study.

這項涉及 3,300 多名患者的八項研究確實提供了許多細節，可以回答您的問題，圍繞目標產品概況、Rocatinlimab 的安全性和耐受性以及其在 SHUTTLE 研究中對特應性皮膚炎患者的全部療效。

We study Rocatinlimab combination with topical steroids or calcineurin in adults with moderate-to-severe AD, data first half of this year.

我們研究了 Rocatinlimab 與局部類固醇或鈣調神經磷酸酶聯合用於中度至重度 AD 成人患者，數據來自今年上半年。

In the IGNITE study, we study monotherapy in adults with moderate-to-severe data first half of this year.

在IGNITE研究中，我們研究了今年上半年成人中度至重度單一治療的數據。

Then in the back half of the year, we have two studies, ASCEND and ASTRO.

然後在今年下半年，我們有兩個研究，ASCEND 和 ASTRO。

ASCEND will help us understand maintenance in adults and adolescents.

ASCEND 將幫助我們了解成人和青少年的維護。

And then ASTRO is an adolescent study with moderate-to-severe AD.

ASTRO 是一項針對中度至重度 AD 的青少年研究。

And so as you can tell, we're going to generate a lot of information about the potential to contribute to a better therapy for this very common in many cases, more of a disease as well as the tolerability profile.

因此正如您所知，我們將產生大量信息，以有助於更好地治療這種在許多情況下非常常見的疾病以及耐受性概況。

Julianne, we've got time for two more.

茱麗安，我們還有時間再說兩句話。

Gregory Renza, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Gregory Renza。

Hi.

你好。

Good afternoon and thanks for taking my question, Bob and team.

下午好，感謝鮑伯和團隊回答我的問題。

Bob, as you and the team talk about the global footprint and leveraging and penetrating new markets, I'm just wondering if you could comment a bit about the opportunity in China and namely, just about the commercial opportunity for those oncology medicines and how that's being achieved through your partnership with BeiGene.

鮑勃，當您和團隊談論全球足跡以及利用和滲透新市場時，我只是想知道您是否可以評論一下中國的機會，特別是這些腫瘤藥物的商業機會以及如何通過與百濟神州的合作實現這些機會。

And maybe just longer term, how is that BeiGene or BeOne arrangement just factoring into those longer-term goals?

也許只是從長期來看，百濟神州或 BeOne 的安排是如何考慮到這些長期目標的？

Thank you very much.

非常感謝。

Maybe we'll take it in two parts.

也許我們可以將其分為兩部分。

Let me just with a high altitude reiterate what I said at the beginning, Gregory, which is that the business is growing globally.

格雷戈里，讓我高度重申我在一開始說的話，那就是我們的業務正在全球增長。

All three of our geographic regions are growing.

我們的三個地理區域均在成長。

Our Japan, Asia Pacific business is the most rapidly growing of our regions right now.

我們的日本、亞太業務是目前成長最快的地區。

So we're really pleased with the performance in Japan and China and elsewhere in the region.

因此，我們對日本、中國和該地區其他地區的表現感到非常滿意。

And the collaboration with BeiGene continues to go well.

與百濟神州的合作持續進展順利。

And Murdo, feel free to jump in and address any specifics about the portfolio there and the plans.

還有 Murdo，請隨意加入並討論有關那裡的投資組合和計劃的任何具體細節。

Yeah.

是的。

Both elements of our business in China are performing well.

我們在中國的業務的兩個要素都表現良好。

The Amgen affiliate business is growing nicely.

安進的附屬業務發展良好。

That's essentially Repatha and Prolia, both products doing well, both products listed on the national reimbursement drug list and growing rapidly as Bob described.

這基本上就是 Repatha 和 Prolia，兩種產品都表現良好，兩種產品都列入了國家報銷藥品名單，並且正如鮑勃所描述的那樣，增長迅速。

And with BeOne, formerly BeiGene, our partnership, I think, has exceeded our expectations in China.

我認為，我們與 BeOne（原百濟神州）的合作已經超出了我們在中國市場的預期。

The team executed extremely well across KYPROLIS, BLINCYTO and XGEVA.

該團隊在 KYPROLIS、BLINCYTO 和 XGEVA 方面表現非常出色。

And we continue to enjoy that partnership and feel good about it.

我們繼續享受這種合作關係並對此感到滿意。

And obviously, we continue to work closely with them on the other R&D projects that we've partnered on.

顯然，我們將繼續與他們密切合作，以進行我們合作的其他研發項目。

So overall, pleased with that.

整體來說，我對此很滿意。

Mohit Bansal, Wells Fargo.

富國銀行的莫希特·班薩爾 (Mohit Bansal)。

Great.

偉大的。

Thank you very much for taking my question.

非常感謝您回答我的問題。

I have a question regarding denosumab and mostly just a franchise mostly in the sense of how should we think about the cadence of a biosimilar erosion of the biosimilars coming?

我有一個關於地諾單抗的問題，主要是關於特許經營的問題，主要是關於我們應該如何看待生物相似藥即將到來的生物仿製藥侵蝕的節奏？

I'm assuming it is more back-half loaded, but would love to get any color how you are thinking about that.

我假設它更多的是後半部分裝載的，但很想知道你對此有何看法。

Sure.

當然。

Murdo, want to address that for Mohit?

Murdo，想為 Mohit 解決這個問題嗎？

Yeah.

是的。

Thanks, Mohit.

謝謝，Mohit。

Well, we have a bit of a clearer understanding on the timing of when biosimilars will enter given the settlements we've reached.

嗯，鑑於我們達成的協議，我們對生物相似藥的進入時間有了更清晰的了解。

So I would agree that the slope of the biosimilar erosion is going to be by definition of the timing, more towards the back end.

因此，我同意生物相似藥侵蝕的斜率將根據時間定義，更多地朝向後端。

I would just encourage everybody to remember the cadence of biosimilar erosion in general.

我只是想鼓勵大家記住生物相似藥侵蝕的節奏。

And the fact that we've got two slightly different situations here with XGEVA largely used in the oncology setting and Prolia used in postmenopausal osteoporosis.

事實上，我們這裡有兩種略有不同的情況，XGEVA 主要用於腫瘤學，而 Prolia 用於停經後骨質疏鬆症。

So the slopes there could be different.

所以那裡的斜坡可能會有所不同。

But overall, we are in a good position, given our participation in the biosimilar market, it teaches us lessons on how to defend successfully on the innovator side.

但總體而言，我們處於有利地位，鑑於我們參與生物相似藥市場，它教會了我們如何在創新者方面成功防禦。

And so, we have a fairly large team of account executives that have been calling on our XGEVA and Prolia accounts for many years now.

因此，我們擁有一個相當大的客戶經理團隊，他們多年來一直在負責我們的 XGEVA 和 Prolia 帳戶。

And we are the bone market leader.

我們是骨骼市場的領導者。

And so, there's a certain incumbency that we have that we think positions us well to defend against other biosimilar competition as they enter the market.

因此，我們認為，我們擁有一定的實力，可以在其他生物相似藥競爭對手進入市場時，很好地抵禦他們的攻擊。

Okay.

好的。

Well, thank you all for your interest and appreciate you joining the call.

好吧，感謝大家的關注並感謝您參加電話會議。

We look forward to catching up after the next quarter.

我們期待下個季度之後能夠趕上進度。

Thank you.

謝謝。

This concludes our 2024 Q4 and full year earnings call.

這就是我們 2024 年第四季和全年財報電話會議的結果。

You may now disconnect

現在您可以斷開連接