美國安進 (AMGN) 2024 Q2 法說會逐字稿

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

現在我謹介紹投資者關係副總裁賈斯汀‧克萊斯先生。克萊斯先生，您可以開始了。

Thank you, Julianne. Good afternoon, everyone, and welcome to our second quarter 2024 earnings call. Bob Bradway will lead the call, and be followed by a broader review of our performance by Murdo Gordon, Vikram Karnani, Jay Bradner, and Peter Griffith.

謝謝朱莉安。大家下午好，歡迎參加我們2024年第二季財報電話會議。鮑勃·布拉德韋將主持會議，隨後默多·戈登、維克拉姆·卡納尼、傑伊·布拉德納和彼得·格里菲斯將對我們的業績進行更全面的回顧。

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. We will also make some forward-looking statements, which are qualified by our Safe Harbor statement. And please note that actual results can vary materially.

在今天的討論中，我們將使用非公認會計準則（非GAAP）財務指標來描述我們的業績，並已在本次電話會議的隨附材料中提供了相應的調節表。我們也將做出一些前瞻性陳述，這些陳述受我們的「安全港」聲明的約束。請注意，實際結果可能與預期有重大差異。

Over to you, Bob.

接下來就交給你了，鮑伯。

Okay. Well, thank you, Justin, and let me thank all of you for joining the call today. We're especially grateful in light of all of the volatility in the markets that you would carve out the time to be with us. So thank you.

好的。謝謝你，賈斯汀，也謝謝各位今天參加電話會議。鑑於市場波動如此劇烈，我們尤其感謝各位抽出時間與我們一起參加。謝謝。

Through the first half of the year, our business is performing well, and we remain confident in our ability to deliver attractive long-term growth. We're achieving strong results the same way we always have, which is by providing innovative medicines to address challenging diseases.

今年上半年，我們的業務表現良好，我們對實現長期成長充滿信心。我們一如既往地取得了優異的業績，那就是提供創新藥物來應對棘手的疾病。

Starting with the in-market portfolio, second quarter revenues grew 20% to $8.4 billion with numerous medicines delivering double-digit sales growth. Including in General Medicine, Repatha and EVENITY, in Oncology, of course, BLINCYTO, in Inflammation TEZSPIRE, and then turning to Rare Disease, which delivered more than $1 billion on the quarter, I would highlight that KRYSTEXXA, UPLIZNA, and TAVNEOS, each delivered at least double-digit sales growth in the quarter, and TEPEZZA grew 8% year-over-year and 13% quarter-over-quarter.

首先來看已上市產品組合，第二季營收成長20%至84億美元，其中多款藥物實現了兩位數的銷售成長。這包括普通內科領域的Repatha和EVENITY，腫瘤領域的BLINCYTO，以及抗發炎領域的TEZSPIRE。罕見疾病領域本季度營收超過10億美元，其中KRYSTEXXA、UPLIZNA和TAVNEOS在本季度均實現了至少兩位數的銷售增長，而TEPEZZA同比增長8%，環比增長13%。

All of these first or best-in-class medicines are still early in their life cycles and have plenty of room to run through geographic expansion, new indications and /or new formulations. You'll hear more about these brands in a moment.

這些首創或同類最佳藥物都還處於生命週期的早期階段，在地理擴張、新適應症和/或新劑型方面還有很大的發展空間。稍後您將聽到更多關於這些品牌的資訊。

Turning to research and development, we believe our pipeline looks very promising as well, not just in obesity, but across all of our therapeutic areas. We told you at the beginning of the year that we were anticipating more than a dozen significant pipeline milestones in 2024. Well, so far, so good.

談到研發方面，我們認為我們的研發管線前景非常光明，不僅在肥胖症領域，而且在所有治療領域都是如此。年初的時候我們就說過，預計2024年會有十幾個重要的研發管線里程碑事件發生。目前來看，一切進展順利。

In the second quarter alone, we received accelerated approval for IMDELLTRA, a landmark new medicine for small cell lung cancer. And in fact, the physicians I've spoken to since approval are really excited about this drug as the first meaningful innovation in decades for these patients. We also received approval for BLINCYTO in the frontline treatment for B-cell precursor acute lymphoblastic leukemia, based on significantly improved overall survival rates. The frontline approval meaningfully expands the potential impact of BLINCYTO for all patients with B-ALL.

僅在第二季度，我們就獲得了 IMDELLTRA 的加速批准，這是一種治療小細胞肺癌的里程碑式新藥。事實上，自從批准以來，我接觸過的醫生都對這種藥物感到非常興奮，認為這是幾十年來針對這類患者的首個真正意義上的創新療法。此外，基於顯著改善的總存活率，我們也獲得了 BLINCYTO 用於 B 細胞前驅急性淋巴性白血病一線治療的批准。一線治療的核准顯著擴大了 BLINCYTO 對所有 B-ALL 患者的潛在療效。

We announced impressive Phase 3 data for UPLIZNA in IgG4-related disease, which is a grievous illness for which there are no currently approved therapies of any kind. Building on our success with TEZSPIRE in treating severe asthma. We announced exciting data from our Phase 2 study in patients with chronic obstructive pulmonary disease that earned this molecule Breakthrough Therapy Designation.

我們公佈了UPLIZNA在IgG4相關疾病（一種目前尚無任何核准療法的嚴重疾病）治療中令人矚目的3期臨床試驗數據。基於TEZSPIRE在治療重度氣喘方面取得的成功，我們宣布了UPLIZNA在慢性阻塞性肺病患者中開展的2期臨床試驗的激動人心的數據，該試驗使UPLIZNA獲得了突破性療法認定。

COPD is the world's third leading cause of death, and new treatment options are very much needed. We look forward to additional data readouts later this year across therapeutic areas, highlighted, of course, by top line data from the ongoing MariTide Phase 2 study. We're encouraged by the emerging data in this field, particularly in cardiovascular and renal disease, areas of long-standing strategic focus for us.

慢性阻塞性肺病（COPD）是全球第三大死因，亟需新的治療方案。我們期待今年稍後在各個治療領域獲得更多數據，其中最引人關注的當然是正在進行的MariTide II期研究的主要數據。我們對該領域湧現的新數據感到鼓舞，尤其是在心血管疾病和腎臟疾病領域，這些領域也是我們長期以來的策略重點。

We are laser focused on preparing to launch a broad Phase 3 program for MariTide that includes obesity, obesity-related conditions and Type 2 diabetes. And we're further ramping our investment to support MariTide in the rest of the pipeline. You'll hear more about that pipeline shortly on this call.

我們正全力以赴地籌備啟動MariTide的第三期臨床試驗項目，涵蓋肥胖症、肥胖相關疾病和第2型糖尿病。同時，我們也進一步增加投資，以支援MariTide在其他研發管線的應用。稍後您將在本次會議中聽到更多關於這些研發管線的資訊。

All in all, this is a very exciting time for us at Amgen, and as always, I'm grateful to my Amgen colleagues all around the world for their enduring commitment to patients.

總而言之，對於安進來說，這是一個非常激動人心的時刻，一如既往，我感謝安進世界各地的同事們對病人的長期奉獻。

And now let me turn things over to Murdo.

現在讓我把麥克風交給默多。

Thanks, Bob. Execution was strong in the second quarter, driving 20% year-over-year sales growth. And all of our regions delivered attractive growth. Sales of 12 products grew at least double-digits, including Repatha, TEZSPIRE, EVENITY, TAVNEOS, and BLINCYTO, all brands that are important to our future growth.

謝謝，鮑伯。第二季執行力強勁，推動銷售額年增20%。我們所有地區的業績都實現了可觀的成長。 12種產品的銷售額實現了兩位數以上的成長，其中包括Repatha、TEZSPIRE、EVENITY、TAVNEOS和BLINCYTO，這些品牌對我們未來的成長都至關重要。

Starting with our General Medicine portfolio. Sales of Repatha, EVENITY and Prolia collectively grew 20% year-over-year in the second quarter, driven by volume growth. Repatha sales increased 25% year-over-year to $532 million for the second quarter. Now well, on its way to becoming a multibillion-dollar business.

首先來看我們的一般藥品產品組合。受銷售成長的推動，Repatha、EVENITY 和 Prolia 三款藥物第二季的總銷售額年增 20%。其中，Repatha 第二季的銷售額年增 25%，達到 5.32 億美元。目前，Repatha 正朝著數十億美元的業務邁進。

In the quarter, we saw year-over-year volume growth of 46%, partially offset by lower net selling price. In the US, we see increased recognition of the importance of lowering LDL cholesterol by health care providers, payers, and patients, which has significantly accelerated volume growth for Repatha.

本季銷量較去年同期成長46%，但部分被淨售價下降所抵銷。在美國，醫療服務提供者、支付者和患者越來越認識到降低低密度脂蛋白膽固醇的重要性，這顯著加速了瑞百安（Repatha）的銷售成長。

Our efforts have broadened insurance coverage and removed prior authorization requirements by several payers. In a recent survey, roughly 95% of cardiologists responded that Repatha is accessible and that access has improved significantly versus two years ago.

我們的努力擴大了保險覆蓋範圍，並取消了多家支付方的事先授權要求。在最近的一項調查中，約95%的心臟科醫生表示Repatha易於獲取，而且與兩年前相比，獲取途徑已顯著改善。

EVENITY sales increased 39% year-over-year to $391 million for the second quarter. In the US, volume growth was supported by both increased prescription volume from existing EVENITY prescribers and an expansion of new prescribers.

第二季度，EVENITY的銷售額年增39%，達到3.91億美元。在美國，銷售量成長得益於現有EVENITY處方醫生處方量的增加以及新處方醫生數量的成長。

In Japan, EVENITY has been prescribed to approximately 600,000 patients to date and continues to be the segment leader with 45% of the bone builder segment. There are many women who remain at risk of a fracture due to postmenopausal osteoporosis. We're encouraged by the growth momentum we are driving and have conviction in the potential for EVENITY to help even more patients.

在日本，EVENITY 迄今已惠及約 60 萬名患者，並以 45% 的市佔率持續維持骨骼強化藥物市場的領先地位。許多女性仍因停經後骨質疏鬆症而面臨骨折風險。我們對目前的成長勢頭感到鼓舞，並堅信 EVENITY 有潛力幫助更多患者。

Prolia sales increased 13% year-over-year to $1.2 billion for the second quarter. Volume growth continues to be supported by real-world evidence demonstrating Prolia's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis at high risk of fracture.

第二季度，Prolia的銷售額年增13%，達到12億美元。真實世界證據表明，對於未接受過治療且骨折風險高的停經後骨質疏鬆症患者，Prolia在降低骨折風險方面優於阿崙膦酸鈉，這持續支撐著銷售量的成長。

In Inflammation, TEZSPIRE continues its strong trajectory with $234 million sales in the second quarter. Sales increased 76% year-over-year, primarily driven by uptake of the prefilled single-use pen. We see strong growth opportunity for TEZSPIRE given its unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma.

在發炎治療領域，TEZSPIRE 繼續保持強勁成長勢頭，第二季銷售額達 2.34 億美元。銷售額年增 76%，主要得益於預填充一次性注射筆的銷售成長。鑑於 TEZSPIRE 獨特的差異化特性及其治療全球 250 萬重度未控制氣喘患者的巨大潛力，我們認為其具有巨大的成長潛力。

Otezla sales decreased 9% year-over-year for the second quarter with 2% volume growth offset by lower net selling price and unfavorable changes to estimated sales deductions. In the US, we saw a 3% year-over-year growth in new patient prescriptions in the quarter, driven by strong execution by our dermatology sales force and increased Otezla direct-to-consumer media activity.

第二季度，Otezla的銷售額年減9%，銷量成長2%，但淨售價下降和預估銷售額扣減的不利變化抵銷了這一降幅。在美國，本季新患者處方量年增3%，這主要得益於我們皮膚科銷售團隊的出色表現以及Otezla面向消費者的媒體宣傳活動的增加。

We've seen an increasingly competitive environment in dermatology with the introduction of novel topicals and new biologic treatments. Otezla retains an important role in this landscape given its broad label, safety profile and unique positioning as a first systemic treatment option for patients with psoriasis.

隨著新型外用藥物和生物製劑的不斷湧現，皮膚科領域的競爭日益激烈。 Otezla憑藉其廣泛的適應症、良好的安全性以及作為銀屑病患者首選系統治療方案的獨特定位，在當前競爭格局中依然扮演著重要的角色。

Enbrel sales decreased 15% year-over-year for the second quarter, primarily driven by lower net selling price. Going forward, we expect continued declining net selling price and relatively flat volumes. Enbrel is known for its efficacy and trusted by physicians. Its substantial health benefits and cash flow generation provide a solid foundation for our business.

第二季恩利（Enbrel）銷售額較去年同期下降15%，主要原因是淨售價降低。展望未來，我們預期淨售價將持續下降，銷售量將保持相對穩定。恩利以其療效著稱，深受醫師信賴。其顯著的健康益處和現金流為我們的業務提供了堅實的基礎。

Turning now to biosimilars, where sales of our biosimilar products were relatively stable year-over-year for the second quarter. We're positioned for future growth with upcoming launches, WEZLANA, biosimilar to STELARA and BKEMV, a biosimilar to Soliris, are both expected to launch in the US in Q1 of 2025. Our vertically integrated biosimilar business model ensures efficiency and provides attractive cash flows and returns for our shareholders.

接下來談談生物相似藥。第二季度，我們生物相似藥產品的銷售額較去年同期保持相對穩定。隨著即將上市的兩款產品，我們已為未來的成長做好準備。其中，STELARA 的生物相似藥 WEZLANA 和 Soliris 的生物相似藥 BKEMV 預計都將於 2025 年第一季在美國上市。我們垂直整合的生物相似藥業務模式確保了效率，並為股東帶來了可觀的現金流和回報。

In Oncology, sales of our seven innovative products, BLINCYTO, LUMAKRAS, Vectibix, KYPROLIS, Nplate, XGEVA, and IMDELLTRA grew 12% year-over-year for the second quarter. Driven by volume growth and higher net selling price. In total, these products contributed almost $2 billion of sales in the second quarter.

在腫瘤治療領域，我們七款創新產品——BLINCYTO、LUMAKRAS、Vectibix、KYPROLIS、Nplate、XGEVA 和 IMDELLTRA——第二季度的銷售額年增 12%，主要得益於銷售成長和淨售價提高。這些產品在第二季共貢獻了近 20 億美元的銷售額。

BLINCYTO sales grew 28% year-over-year to $264 million for the second quarter, driven by broad prescribing across academic and community segments for patients with B-cell ALL. BLINCYTO was recently granted approval by the US Food and Drug Administration as a frontline consolidation treatment for patients with Philadelphia chromosome-negative B-cell ALL. Our commercial and medical teams are engaging key academic, regional, and community customers in establishing BLINCYTO as a standard of care in this setting.

BLINCYTO第二季度銷售額年增28%，達到2.64億美元，主要得益於學術機構和社區醫療機構在B細胞急性淋巴性白血病（B-ALL）患者中的廣泛應用。 BLINCYTO近期獲得美國食品藥物管理局（FDA）批准，作為費城染色體陰性B-ALL患者的第一線鞏固治療方案。我們的商業和醫學團隊正與重要的學術機構、區域醫療機構和社區醫療機構合作，致力於將BLINCYTO打造成為該領域標準的治療方案。

LUMAKRAS sales increased 10% year-over-year to $85 million for the second quarter. We see future growth opportunities for LUMAKRAS coming from launches in new markets and additional indications. Vectibix sales increased 9% year-over-year to $270 million for the second quarter, now annualizing at over $1 billion. We also drove strong performance of KYPROLIS, which grew 9% year-over-year and Nplate, which grew 12% year-over-year.

LUMAKRAS第二季銷售額年增10%，達到8,500萬美元。我們認為，LUMAKRAS未來的成長機會主要來自新市場的上市和更多適應症的擴展。 Vectibix第二季銷售額年增9%，達2.7億美元，年化銷售額超過10億美元。此外，KYPROLIS和Nplate也表現出色，分別較去年同期成長9%和12%。

Since our U.S. launch of IMDELLTRA in mid-May, we generated $12 million of sales in the second quarter. IMDELLTRA was recently approved for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

自5月中旬在美國推出IMDELLTRA以來，我們在第二季實現了1,200萬美元的銷售額。 IMDELLTRA近期獲準用於治療接受鉑類化療期間或之後病情進展的廣泛期小細胞肺癌成人患者。

We're seeing strong clinical conviction in IMDELLTRA in both academic and community settings, and while very early in the launch, we're encouraged by the adoption of IMDELLTRA and look forward to its potential to bring new possibilities to patients living with this aggressive disease. I'm pleased with our execution in the quarter, driving accelerated performance for our most important growth brands.

我們看到，無論是在學術機構還是社區醫療機構，IMDELLTRA 都獲得了強烈的臨床認可。雖然上市時間尚處於早期階段，但我們對 IMDELLTRA 的接受度感到鼓舞，並期待它能為患有這種侵襲性疾病的患者帶來新的希望。我對本季的業績表現感到滿意，我們最重要的成長品牌實現了加速成長。

And with that, I'll turn it over to Vikram, who will cover our rare disease portfolio.

接下來，我將把麥克風交給 Vikram，他將負責介紹我們的罕見疾病產品組合。

Thank you, Murdo. I am pleased to provide an update on rare disease, which delivered product sales of over $1.1 billion in Q2. Beginning with TEPEZZA for the treatment of thyroid-eye disease, second quarter sales were $479 million, reflecting growth of 8% year-over-year and 13% quarter-over-quarter when compared to results from the legacy Horizon business.

謝謝，默多。我很高興向大家報告罕見疾病業務的最新進展，該業務第二季產品銷售額超過11億美元。首先是用於治療甲狀腺眼疾的TEPEZZA，此藥第二季銷售額為4.79億美元，較去年同期成長8%，較上季成長13%（與原Horizo​​​​n業務相比）。

Recall that there are roughly 100,000 TED patients in the U.S., and penetration is currently only in the single digits. The main growth opportunity is within the roughly 80% of TED patients, who have a low clinical activity score or CAS.

需要注意的是，美國約有10萬名甲狀腺眼疾（TED）患者，但目前的市場滲透率只有個位數。主要的成長機會在於約佔TED患者總數80%的低臨床活動評分（CAS）患者族群。

We are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many of the low CAS patients who can benefit from TEPEZZA. The impact of thyroid eye disease on quality of life is often underestimated. So our focus is on educating health care providers about the significant effects on patients, even those with less visible symptoms.

我們正在擴大新處方醫生的覆蓋範圍，特別是眼科醫生和內分泌科醫生，他們負責管理許多低CAS評分的患者，這些患者可以從TEPEZZA中獲益。甲狀腺眼疾對生活品質的影響常常被低估。因此，我們的重點是教育醫療保健提供者，讓他們了解甲狀腺眼疾對患者的顯著影響，即使是那些症狀不太明顯的患者。

In addition, we are increasing our strategic focus in endocrinology with a dedicated sales force to engage in this important space. We are also making significant strides in improving access, thanks to the recognition of TEPEZZA's efficacy by payers.

此外，我們正加大對內分泌領域的策略投入，組成專門的銷售團隊，積極開拓這一重要領域。同時，由於支付方認可了TEPEZZA的療效，我們在改善患者可近性方面也取得了顯著進展。

To date, we have achieved favorable medical policy changes for greater than 55% of US covered lives, compared to 50% last quarter, and just 5% roughly one year ago. We expect to continue this momentum throughout 2024. International expansion remains a meaningful long-term growth opportunity for TEPEZZA with regulatory filings complete or underway in multiple geographies. With Japan as the next significant launch expected by early 2025. We also initiated a Phase 3 subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation.

迄今為止，我們已為超過55%的美國投保人員爭取到了有利的醫療政策變更，高於上季度的50%，而大約一年前這一比例僅為5%。我們預計這一勢頭將持續到2024年。國際擴張仍然是TEPEZZA重要的長期成長機遇，我們在多個地區已完成或正在進行監管申報。預計日本將是下一個重要的上市市場，預計2025年初推出。此外，我們也啟動了一項皮下注射的III期研究，並認為這是一個提高產品接受度、改善患者體驗的機會，可以為我們的現有靜脈注射製劑提供一種替代方案。

KRYSTEXXA for patients with chronic refractory gout, delivered $294 million in sales in Q2, representing 20% year-over-year growth, driven by volume growth from strong commercial execution. KRYSTEXXA with immunomodulation continues to redefine the standard of care for uncontrolled gout.

用於治療慢性難治性痛風的KRYSTEXXA在第二季度銷售額達2.94億美元，年增20%，主要得益於強勁的商業執行帶來的銷售成長。 KRYSTEXXA以其免疫調節作用，持續重新定義難治性痛風的治療標準。

UPLIZNA, for patients with neuromyelitis optica spectrum disorder, or NMOSD, delivered $92 million in sales in Q2, representing 35% year-over-year growth. International expansion of UPLIZNA is also underway with launches in multiple ex-US markets, including Canada, which launched earlier this year.

用於治療視神經脊髓炎譜系障礙（NMOSD）的藥物UPLIZNA，第二季銷售額達9,200萬美元，較去年同期成長35%。 UPLIZNA的國際擴張也在進行中，已在多個美國以外的市場上市，包括今年稍早在加拿大上市的加拿大。

In addition to NMOSD, we are excited about the impressive Phase 3 results with UPLIZNA in IgG4-related disease. And the potential it has to address a debilitating condition that impacts more than 20,000 patients in the U.S.. We also look forward to the Phase 3 readout for UPLIZNA in myasthenia gravis later this year. Jay will address these in more detail in a moment.

除了視神經脊髓炎譜系障礙（NMOSD）之外，我們對UPLIZNA在IgG4相關疾病中令人矚目的3期臨床試驗結果也感到非常興奮。它有望治療一種影響美國超過2萬名患者的嚴重疾病。我們也期待今年稍後UPLIZNA在重症肌無力治療的3期臨床試驗結果發表。 Jay稍後會更詳細地介紹這些內容。

Sales of TAVNEOS were $71 million for the second quarter. Sales increased 137% year-over-year, driven by volume growth. In the US more than 3,500 patients with ANCA-associated vasculitis have been treated with TAVNEOS. Over 2,300 health care professionals have now prescribed TAVNEOS, a roughly 35% increase in the prescriber base so far this year. The integration of the legacy Horizon business is progressing nicely as we leverage Amgen's leadership in inflammation, world class manufacturing and process development, and extensive global footprint.

TAVNEOS第二季銷售額達7,100萬美元，年增137%，主要得益於銷售成長。在美國，已有超過3500名ANCA相關性血管炎患者接受了TAVNEOS治療。目前已有超過2,300名醫療專業人員開立了TAVNEOS處方，較今年迄今的處方醫生數量增加了約35%。隨著我們充分利用安進在發炎治療領域的領先地位、世界一流的生產製造和製程開發能力以及廣泛的全球佈局，原Horizo​​n業務的整合工作進展順利。

Now I will pass it over to Jay for our R&D update.

現在我將把話題交給傑伊，讓他為我們帶來研發進展的最新情況。

Thank you, Vikram, and good afternoon, everyone. In the second quarter, we rapidly advanced our broad clinical pipeline of potentially first-in-class or best-in-class programs. We received two approvals in the quarter. A Breakthrough Therapy Designation and delivered exciting clinical data for many programs, while eagerly awaiting additional data readouts later this year.

謝謝Vikram，大家下午好。第二季度，我們迅速推進了許多具有首創或同類最佳潛力的臨床研發項目。本季我們獲得了兩項批准，一項是突破性療法認定，並公佈了多個項目的令人振奮的臨床數據，同時我們也熱切期待今年稍後公佈更多數據。

Let's begin with General Medicine. As previously mentioned, based on the interim analysis, we are seeing a differentiated profile with MariTide and are confident it will address important unmet medical needs in obesity, obesity-related conditions, and Type 2 diabetes.

我們先從全科醫學說起。如前所述，根據中期分析，我們發現 MariTide 具有差異化優勢，並相信它能夠滿足肥胖症、肥胖相關疾病和 2 型糖尿病領域的重要未滿足醫療需求。

We remain on track and look forward to top line 52-week data from the ongoing MariTide Phase 2 study in late 2024. We are actively planning and expect to initiate a broad Phase 3 program in obesity, obesity-related conditions, and diabetes, along with a Phase 2 trial investigating MariTide for the treatment of diabetes in patients with and without obesity.

我們仍按計劃推進，並期待在 2024 年底獲得正在進行的 MariTide 二期研究的 52 週主要數據。我們正在積極規劃並計劃啟動一項針對肥胖症、肥胖相關疾病和糖尿病的廣泛三期項目，以及一項研究 MariTide 治療肥胖和非肥胖糖尿病患者的二期試驗。

Beyond MariTide, we continue to progress our early obesity programs that consists of both oral and injectable incretin and non-incretin approaches. We expect one of these programs to enter clinical development later this year. Also in Gen Med is olpasiran, our potentially best-in-class Lp(a) targeting small interfering RNA medicine.

除了 MariTide 之外，我們還在持續推進早期肥胖症治療項目，包括口服和注射腸促胰素和非腸促胰素療法。我們預計其中一個項目將於今年稍後進入臨床開發階段。此外，在普通醫學領域，我們也正在研發 olpasiran，這是一種針對 Lp(a) 的小幹擾 RNA 藥物，有望成為同類最佳藥物。

The fully enrolled Phase 3 cardiovascular outcomes trial of olpasiran continues to progress. To remind, Lp(a) is a genetically defined cardiovascular risk factor that is elevated in approximately 20% of individuals and for whom no effective or targeted therapies currently exist. In Oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering transformative clinical benefit for patients.

奧帕司坦（olpasiran）的3期心血管結局試驗已完成全部受試者招募，目前仍在順利進行中。需要指出的是，Lp(a)是一種基因定義的心血管風險因素，約20%的人群Lp(a)水準升高，目前尚無針對此風險因子的有效標靶療法。在腫瘤領域，我們持續致力於研發差異化療法，以實現高預期目標，為患者帶來變革性的臨床效益。

Let's begin with IMDELLTRA, our first-in-class bispecific T-cell engager, or BiTE molecule, targeting DLL3 for small cell lung cancer. We're very pleased that the FDA granted accelerated approval to IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

我們先來介紹一下IMDELLTRA，這是我們首創的雙特異性T細胞銜接器（BiTE）分子，標靶DLL3，用於治療小細胞肺癌。我們非常高興地宣布，FDA已加速批准IMDELLTRA用於治療接受過鉑類化療後病情進展的廣泛期小細胞肺癌成人患者。

Further, we are pleased that the NCCN guidelines have been updated to include IMDELLTRA as a preferred option for patients with a chemotherapy-free interval less than or equal to six months and as an "Other Recommended Treatment Option" for patients with a chemotherapy-free interval greater than six months. Based on the remarkable activity observed as a single agent in patients receiving second and third line therapy, we are rapidly advancing IMDELLTRA into frontline therapy with three Phase 3 studies underway in both extensive and limited stage disease.

此外，我們欣喜地看到NCCN指引已更新，將IMDELLTRA列為化療間隔期≤6個月患者的首選治療方案，以及化療間隔期＞6個月患者的「其他推薦治療方案」。鑑於IMDELLTRA作為單藥在二線和三線治療患者中展現出的顯著療效，我們正迅速推進其一線治療，目前正在進行三項針對廣泛期和局限期疾病的III期臨床研究。

One of these studies, DeLLphi-304, our confirmatory Phase 3 study in second line small cell lung cancer has completed enrollment. Notably, IMDELLTRA is the first bispecific T-cell engager approved to treat a common solid tumor. The present study of tarlatamab in earlier lines and in the context of lower tumor burden, draws from our experience with our first approved bispecific T-cell engager BLINCYTO in B-cell acute lymphoblastic leukemia.

其中一項研究，DeLLphi-304，是我們針對二線小細胞肺癌進行的確證性III期研究，已完成病患招募。值得注意的是，IMDELLTRA是首個獲準用於治療常見實體瘤的雙特異性T細胞銜接器。目前這項針對早期治療和較低腫瘤負荷患者的tarlatamab研究，借鑒了我們首個獲批的雙特異性T細胞銜接器BLINCYTO在B細胞急性淋巴細胞白血病治療中的經驗。

Here, we observed a dramatic improvement in overall survival in minimal residual disease negative patients, along with improved tolerability. These BLINCYTO data provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells that are drivers of occurrence.

在此，我們觀察到微小殘留病灶陰性患者的總存活期顯著延長，且耐受性也得到改善。這些BLINCYTO數據表明，以這種方式引導T細胞是尋找並清除殘留癌細胞（這些殘留癌細胞是疾病復發的驅動因素）的有效方法。

This June, based on the profound survival benefit observed in the treatment of frontline disease, the FDA approved an additional indication for BLINCYTO for the treatment of adult and pediatric patients one month or older with CD19 positive, Philadelphia chromosome negative, B-cell ALL and the consolidation phase of treatment, here regardless of minimal residual disease status. We continue to seek to expand the impact of BLINCYTO in newly diagnosed B-ALL through ongoing studies and with the further investigation of subcutaneous administration.

今年六月，基於一線治療中觀察到的顯著生存獲益，FDA批准了BLINCYTO新增適應症，用於治療CD19陽性、費城染色體陰性、B細胞急性淋巴細胞白血病（B-ALL）的成人和兒童患者（1個月及以上），以及鞏固治療階段，無論微小殘留病灶狀態如何。我們將繼續透過持續的研究和對皮下給藥的進一步探索，努力擴大BLINCYTO在初診B-ALL中的應用。

Our first-in-class STEAP1 CD3 bispecific molecule, xaluritamig, has also demonstrated profound clinical activity in metastatic castrate resistant prostate cancer. Importantly, demonstrating our ability to target a second common solid tumor with a bispecific T-cell engager therapy. We are rapidly advancing this program and have now fully enrolled the monotherapy Phase 1 dose expansion as we continue to enroll patients in reduced monitoring and outpatient cohorts.

我們首創的STEAP1 CD3雙特異性分子藥物xaluritamig在轉移性去勢抗性前列腺癌中也展現出顯著的臨床活性。更重要的是，這顯示我們有能力利用雙特異性T細胞銜接器療法標靶治療另一種常見的實體腫瘤。我們正在快速推進該項目，目前已完成單藥治療I期劑量擴展試驗的全部入組，並繼續招募患者參與減少監測和門診治療。

Further, we are advancing the study of xaluritamig earlier in the prostate cancer treatment paradigm with combinations of xaluritamig and enzalutamide or abiraterone ongoing while we plan additional studies in earlier disease settings.

此外，我們正在推動 xaluritamig 在前列腺癌治療方案中更早階段的研究，同時進行 xaluritamig 與恩扎盧胺或阿比特龍聯合用藥的研究，併計劃在更早期的疾病階段開展更多研究。

In sum, with regard IMDELLTRA, BLINCYTO, xaluritamig as major advances, further establishing the broad potential of our leading bispecific T-cell engager platform. To round out oncology, we have completed enrollment of FORTITUDE-101, a Phase 3 study of bemarituzumab, a first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody administered in combination with chemotherapy in frontline gastric cancer.

總之，IMDELLTRA、BLINCYTO 和 xaluritamig 的取得標誌著我們取得了重大進展，進一步確立了我們領先的雙特異性 T 細胞銜接器平台的廣泛潛力。在腫瘤領域，我們已完成 FORTITUDE-101 的受試者招募。 FORTITUDE-101 是一項 III 期臨床研究，旨在評估 bemarituzumab（一種首創的靶向成纖維細胞生長因子受體 IIb 的單株抗體）聯合化療一線治療胃癌的療效。

We are also rapidly advancing AMG 193, our oral PRMT5 inhibitor developed for MTAP-null solid tumors as both a monotherapy and in combination with other therapies. Additional data from the Phase 1 dose escalation and initial dose expansion study of AMG 193 in patients with MTAP-null solid tumors, will be presented at ESMO in September. Lastly, we are pleased also to share that the FDA has granted an Orphan Drug Designation to AMG 193 for the treatment of pancreatic cancer.

我們正在快速推進口服PRMT5抑制劑AMG 193的研發，該藥物專為MTAP缺失型實體瘤開發，可作為單藥療法或與其他療法合併使用。 AMG 193在MTAP缺失型實體瘤患者中進行的I期劑量遞增研究和初始劑量擴展研究的更多數據將於9月在ESMO大會上公佈。最後，我們很高興地宣布，FDA已授予AMG 193治療胰臟癌的孤兒藥資格認定。

Turning to Inflammation, we are encouraged by the data arising from our Phase 2 study of TEZSPIRE in patients with moderate to very severe COPD. Together with AstraZeneca, we are actively planning for Phase 3 development in COPD.

在發炎治療方面，我們對TEZSPIRE治療中度至重度慢性阻塞性肺病（COPD）患者的II期研究數據感到鼓舞。我們正與阿斯特捷利康積極籌備COPD的III期臨床試驗。

We are also pleased to announce that the FDA recently granted TEZSPIRE, a Breakthrough Therapy Designation, as an add-on maintenance treatment of patients with moderate to very severe COPD, characterized by the eosinophilic phenotype.

我們也很高興地宣布，FDA 最近授予 TEZSPIRE 突破性療法認定，作為嗜酸性表型的中度至重度 COPD 患者的附加維持治療。

Beyond COPD, we continue to explore TEZSPIRE in separate Phase 3 studies in eosinophilic esophagitis - and in chronic rhinosinusitis with nasal polyps, where top line data are expected later this year. Turning to rocatinlimab, a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor. The comprehensive rocatinlimab Phase 3 ROCKET program has successfully enrolled over 3,100 patients with moderate to severe atopic dermatitis.

除了慢性阻塞性肺病（COPD）之外，我們還在嗜酸性食道炎和伴有鼻息肉的慢性鼻竇炎的獨立3期研究中繼續探索TEZSPIRE的療效，預計將於今年稍後公佈初步數據。接下來是rocatinlimab，這是一種針對OX40受體的首創T細胞平衡單株抗體。 rocatinlimab的綜合性3期ROCKET計畫已成功招募了超過3,100名中重度異位性皮膚炎患者。

Five of the eight studies are now fully enrolled. The Phase 3 HORIZON study, part of this ROCKET program evaluates rocatinlimab monotherapy versus placebo in adults with moderate to severe atopic dermatitis. And it is ongoing with data readout anticipated in H2. Beyond atopic dermatitis, we continue to explore the potential of rocatinlimab in additional indications and have initiated a Phase 2 study in moderate to severe asthma as well as a Phase 3 study in prurigo nodularis. Shifting to Rare Disease, we are encouraged by the advancements of our rare disease pipeline with several mid- to late-stage opportunities.

八項研究中已有五項完成全部受試者招募。作為 ROCKET 計畫的一部分，HORIZON III 期研究正在評估 rocatinlimab 單藥治療與安慰劑治療中重度異位性皮膚炎成人患者的療效。該研究正在進行中，預計下半年公佈數據。除了異位性皮膚炎外，我們還在持續探索 rocatinlimab 在其他適應症中的潛力，並已啟動一項針對中重度氣喘的 II 期研究以及一項針對結節性癢疹的 III 期研究。在罕見疾病領域，我們對罕見疾病產品線的進展感到鼓舞，目前已有多個處於中後期階段的項目。

UPLIZNA, a CD19 B-cell depleting therapy offers a differentiated mechanism of action than other autoimmune therapies, durable efficacy with a convenient every six month IV dosing schedule. This could be very important for chronic inflammatory diseases.

UPLIZNA 是一種 CD19 B 細胞清除療法，與其他自體免疫療法相比，其作用機制不同，療效持久，且每六個月靜脈注射一次，給藥方案便捷。這對於治療慢性發炎性疾病可能具有重要意義。

Recently, we were excited to announce positive top line results from a Phase 3 clinical trial evaluating the efficacy and safety of UPLIZNA for the treatment of immunoglobulin G4-related disease. The trial met its primary endpoint, showing an astonishing 87% reduction in the risk of IgG4-related disease flare, as compared to placebo during the 52 week placebo-controlled window.

近日，我們很高興地宣布了一項評估UPLIZNA治療IgG4相關疾病療效和安全性的3期臨床試驗的積極初步結果。該試驗達到了主要終點，在為期52週的安慰劑對照試驗中，與安慰劑組相比，UPLIZNA組IgG4相關疾病復發的風險顯著降低了87%。

All key secondary endpoints were also met and no new safety signals were identified. This is the first randomized controlled trial to demonstrate efficacy in the IgG4-related disease patient population, regulatory filing activities are underway and full data from the trial will be presented at a future medical meeting.

所有關鍵次要終點均已達到，且未發現新的安全性訊號。這是首個證實該藥物對IgG4相關疾病患者群體療效的隨機對照試驗，目前正在進行監管申報工作，試驗的完整數據將在未來的醫學會議上公佈。

We are also studying UPLIZNA in generalized myasthenia gravis through the ongoing Phase 3 MINT study. The MINT study is evaluating the efficacy and safety of UPLIZNA in patients with generalized myasthenia gravis, who are of a comparable disease severity and a comparable treatment experience to other recently approved biologic therapies.

我們目前也正在透過正在進行的 III 期 MINT 研究來評估 UPLIZNA 在全身型重症肌無力患者中的療效和安全性。 MINT 研究旨在評估 UPLIZNA 在全身型重症肌無力患者中的療效和安全性，這些患者的疾病嚴重程度和治療經驗與其他近期獲準的生物製劑患者相當。

We are investigating UPLIZNA in the two predominant antibody serotypes that drive this disease, Acetylcholine Receptor positive and in Muscle-Specific Tyrosine Kinase-positive patients. MINT is the only trial attempting to demonstrate efficacy while removing the treatment benefit of steroids. Patients in the MINT trial who entered on steroids had a protocol-specified taper by 24 weeks. We look forward to data readout in the second half of 2024.

我們正在研究UPLIZNA在兩種主要抗體血清型（乙醯膽鹼受體陽性和肌肉特異性酪胺酸激酶陽性）患者中的療效，這兩种血清型是導致疾病的主要抗體類型。 MINT是唯一一項嘗試在去除類固醇治療獲益的情況下驗證療效的試驗。 MINT試驗中，入組時正在接受類固醇治療的患者依方案規定，在24週內逐漸減量停藥。我們期待在2024年下半年獲得數據。

To expand the impact of our CD19 directed therapeutics to even more patients suffering from serious inflammatory diseases, compelled by both biological inferences and insights from small studies of CD19-directed therapies, we are launching a development program targeting CD19 positive B cell-mediated autoimmune disease with UPLIZNA and blinatumomab.

為了擴大我們 CD19 標靶療法對更多患有嚴重發炎性疾病的患者的影響，在生物學推斷和 CD19 標靶療法小規模研究的啟發下，我們正在啟動一項針對 CD19 陽性 B 細胞介導的自身免疫性疾病的開發計劃，該計劃使用 UPLIZNA 和 blinatumomab。

This is an exciting and promising space with Amgen's strong capabilities in inflammatory disease and two well-characterized assets, we are very well positioned to lead in this rapidly advancing field. We will have more to say about these programs in due course.

這是一個令人振奮且充滿前景的領域，安進在發炎性疾病領域擁有強大的實力，並擁有兩項特性明確的在研產品，我們完全有能力在這個快速發展的領域中佔據領先地位。我們將在適當的時候公佈更多關於這些項目的資訊。

Lastly, in May, the FDA approved BKEMV as the first interchangeable biosimilar to Soliris (or eculizumab). Also in biosimilar development, registration-enabling studies are underway for ABP 234 and a biosimilar candidate to KEYTRUDA and ABP 206, a biosimilar candidate to OPDIVO.

最後，在5月份，FDA批准了BKEMV作為第一個可與Soliris（或依庫珠單抗）互換的生物相似藥。此外，在生物相似藥的研發方面，ABP 234（一種KEYTRUDA的生物相似藥候選藥物）和ABP 206（一種OPDIVO的生物相似藥候選藥物）的註冊研究正在進行中。

In closing, I'd like to thank my Amgen colleagues for their strong sense of service to patients facing serious illness, their intense focus and spirited collaboration during this momentous year, and their commitment to growing the impact of both our research and our business - through this portfolio of potential first-in-class and best-in-class medicines.

最後，我要感謝安進的同事們，感謝他們對身患重病的患者的強烈服務意識，感謝他們在這一重要年份裡的高度專注和積極合作，感謝他們致力於通過這一系列潛在的首創和同類最佳藥物，擴大我們的研究和業務的影響力。

I'll now turn it over to Peter.

現在我把麥克風交給彼得。

Thank you, Jay. We're pleased with our strong second quarter performance and are on track with our 2024 full year goals and long-term objectives. We have a strong long-term growth outlook across our four therapeutic areas, driven by the breadth and depth of our innovative pipeline and in-market products, serving patients with serious illnesses around the globe.

謝謝傑伊。我們對第二季強勁的業績感到滿意，並朝著2024年全年目標和長期目標穩步邁進。憑藉我們創新研發管線和上市產品的廣度和深度，我們在四大治療領域均擁有強勁的長期成長前景，致力於服務全球重症患者。

Starting with our second quarter results, as shown on slide 27 of the slide deck, we delivered $8.4 billion in total revenue, a 20% increase year-over-year. It's the highest quarterly revenue in Amgen history, achieved with 26% volume growth. This means more patients than ever are receiving Amgen medicines.

從我們第二季的業績來看（如投影片第27頁所示），我們實現了84億美元的總收入，比去年同期成長20%。這是安進史上最高的季度收入，銷量成長了26%。這意味著比以往任何時候都多的患者正在接受安進的藥物治療。

Excluding the addition of Horizon, product sales increased 5% year-over-year, driven by 10% volume growth. In the second quarter, we delivered a non-GAAP operating margin of 48.2% as a percentage of product sales with total non-GAAP operating expenses increasing 30% year-over-year. Non-GAAP cost of sales as a percent of product sales increased 0.4 percentage points on a year-over-year basis, primarily driven by higher royalties and profit share due to changes in sales mix.

剔除Horizo​​n的新增銷售額，產品銷售額年增5%，主要得益於銷售成長10%。第二季度，我們實現了48.2%的非GAAP營業利潤率（佔產品銷售額的百分比），非GAAP營業總費用較去年同期成長30%。非GAAP銷售成本佔產品銷售額的百分比年增0.4個百分點，主要原因是銷售組合變化導致特許權使用費和利潤分成增加。

Non-GAAP R&D spending in the second quarter increased 30% year-over-year as we strategically invested in the late-stage pipeline, including MariTide, Rocatinlimab, and bemarituzumab as well as, Horizon acquired programs. Non-GAAP SG&A expenses increased 36% year-over-year, primarily driven by the addition of Horizon. Excluding the addition of Horizon, non-GAAP SG&A expenses increased 14% year-over-year, driven by investment in Repatha, Otezla, and EVENITY.

第二季非GAAP研發支出年增30%，主要得益於我們對後期研發管線的策略性投資，包括MariTide、Rocatinlimab和bemarituzumab，以及收購Horizo​​n的專案。非GAAP銷售、管理及行政費用年增36%，主要受Horizo​​​​n收購的影響。若不計入Horizo​​n的收購，非GAAP銷售、管理及行政費用年增14%，主要受Repatha、Otezla和EVENITY投資的影響。

Our non-GAAP OI&E resulted in a $700 million expense, up $400 million year-over-year, almost entirely due to increased interest expenses from the Horizon acquisition. We remain on track to deleverage with line of sight to retiring greater than $10 billion of debt by the end of 2025. This includes $1.4 billion of debt retired in the second quarter and $2.0 billion year-to-date.

我們的非GAAP營運盈餘及支出（OI&E）為7億美元，年增4億美元，幾乎全部是由於收購Horizo​​​​n導致的利息支出增加。我們仍按計畫推進去槓桿化進程，目標是在2025年底前償還超過100億美元的債務。這其中包括第二季償還的14億美元債務和年初至今償還的20億美元債務。

Our non-GAAP tax rate decreased 1.5 percentage points year-over-year to 14.9%, primarily due to the change in sales mix from the inclusion of our Horizon.

由於納入 Horizo​​n 後銷售組合發生變化，我們的非 GAAP 稅率年減 1.5 個百分點至 14.9%。

In the second quarter of 2024, the company generated $2.2 billion of free cash flow, a decrease of $3.8 billion -- a decrease from $3.8 billion in the previous year, driven by the timing of tax payments. In 2023, federal tax payments, including our repatriation tax were made in the fourth quarter. Whereas in 2024, these payments were made in the second quarter. The Horizon integration is progressing well, and we expect to reach $500 million in pretax synergies by year three post-acquisition, with roughly 50% to be realized by the end of this year.

2024年第二季度，公司自由現金流為22億美元，較上年同期減少38億美元，主要原因是稅金繳納時間的調整。 2023年，包括利潤匯回稅在內的聯邦稅款在第四季度繳納；而2024年，這些稅款則在第二季度繳納。 Horizo​​n的整合進展順利，我們預計在收購後的第三年實現5億美元的稅前協同效應，其中約50%將於今年年底前實現。

We expect accretion to non-GAAP earnings per share in 2024. We continue to execute on our capital allocation priorities. We're investing in the best innovation, both internally and externally to rapidly advance an innovative pipeline, multiple potentially first-in-class and / or best-in-class medicines across the four therapeutic areas.

我們預計2024年非GAAP每股盈餘將有所成長。我們將繼續執行既定的資本配置優先事項。我們正在投資最佳創新，包括內部和外部的創新，以快速推進創新產品線，在四大治療領域開發多種潛在的首創或同類最佳藥物。

As I said earlier, this is reflected in our second quarter non-GAAP R&D spend of $1.4 billion, an increase of 30% year-over-year. Second, we continue investing in our business for long-term growth. We are expanding capacity in our state-of-the-art manufacturing facilities, including investments to support MariTide.

正如我之前所說，這體現在我們第二季非GAAP研發支出為14億美元，比去年同期成長30%。其次，我們持續投資於業務的長期成長。我們正在擴大先進製造工廠的產能，包括對MariTide的支持性投資。

Beyond manufacturing, we are opening a new global technology and innovation center in Hyderabad, India, which will attract talent at scale and accelerate digital capabilities across the organization, including artificial intelligence, data science, life science, and medical. And third, we returned capital to shareholders as we paid competitive dividends of $2.25 per share in the second quarter. This represented a 6% increase compared to 2023.

除了生產製造之外，我們還在印度海得拉巴開設了一個新的全球技術與創新中心，該中心將大規模吸引人才，並加速整個組織的數位化能力建設，包括人工智慧、數據科學、生命科學和醫療領域。第三，我們向股東返還了資本，在第二季度派發了每股2.25美元的具有競爭力的股息。這比2023年增長了6%。

Turning to the outlook for the business for 2024 on slide 29. We expect our 2024 total revenues in the range of $32.8 billion to $33.8 billion and non-GAAP earnings per share between $19.10 and $20.10. I will mention a few considerations as you model the remainder of 2024.

接下來，我們來看看第29頁幻燈片中關於2024年業務展望的內容。我們預計2024年總收入將在328億美元至338億美元之間，非GAAP每股收益將介於19.10美元至20.10美元之間。在您建立2024年剩餘時間的模型時，我將提及一些需要考慮的因素。

On revenues, we expect mid-single-digit growth quarter-over-quarter in the fourth quarter compared to Q3. Our full year non-GAAP R&D expenses are now expected to increase more than 25% year-over-year as we further invest in our late-stage pipeline to support multiple late-stage studies underway across all therapeutic areas. As a result, we now project the full year non-GAAP operating margin as a percentage of product sales to be roughly 47%, with Q3 operating margin lower than Q2.

營收方面，我們預計第四季將季比將實現中等個位數成長，高於第三季。由於我們將進一步投資於後期研發管線，以支援所有治療領域正在進行的多項後期研究，因此我們預計全年非GAAP研發支出將年增超過25%。因此，我們目前預期全年非GAAP營業利潤率（佔產品銷售額的百分比）約為47%，其中第三季營業利潤率低於第二季。

Total non-GAAP operating expenses for the third quarter are expected to grow at a similar rate to the first two quarters of this year. We expect OI&E to be approximately $2.5 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition. We continue to expect the non-GAAP tax rate to be in the 15% to 16% range, including the full year benefits associated with the inclusion of the Horizon business.

預計第三季非GAAP營運總支出將與今年前兩季成長相近。我們預計營運支出總額約為25億美元，其中包括為收購Horizo​​​​n而籌集的280億美元債務相關的利息支出。我們仍然預計非GAAP稅率將在15%至16%之間，其中包括Horizo​​​​n業務併入公司後全年帶來的收益。

As we have previously indicated, we have initiated activities to further expand MariTide manufacturing capacity. To support these initial efforts, we now expect capital expenditures of $1.3 billion in 2024 versus our most recent guidance of $1.1 billion to $1.2 billion. Our long-term outlook remains robust, and I am grateful to our 27,000 plus colleagues worldwide for their dedication to serve patients. This concludes our financial update.

正如我們之前所述，我們已啟動相關活動，進一步擴大MariTide的生產能力。為支持這些初步工作，我們預計2024年的資本支出將達到13億美元，高於先前11億至12億美元的預期。我們的長期前景依然穩健，我衷心感謝全球27,000多位同事為服務患者所做的貢獻。以上是本次財務更新的全部內容。

We will now begin our Q&A session. Julianne, please remind our participants of the process. Thank you.

現在開始問答環節。朱莉安娜，請你提醒各位參與者問答流程。謝謝。

(Operator Instructions).

（操作說明）

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great. Thank you and ery nice result and thanks so much.

太好了。謝謝，結果非常好，非常感謝。

Jay, maybe a question for you, actually. I want to start with the UPLIZNA. And we noticed a few things. The MINT study was supposed to have complete -- completion around mid-May. And Amgen just posted a whole bunch of new job postings for gMG and you have a slot on October 15, at the MGFA to present the data.

傑伊，或許我有個問題想問你。我想先從UPLIZNA說起。我們注意到一些事情。 MINT研究原本應該在五月中旬左右完成。安進公司剛發布了一大批gMG的新職位，而你將於10月15日在MGFA大會上發表數據報告。

As you noted, you're doing steroid tapering. It's a different trial design, but you also did steroid tapering and the other two indications, NMOSD and IgG4. Can you talk a little bit sort of what are you hoping to see and what are you expecting to see from the data?

正如你所提到的，您正在進行類固醇減量試驗。雖然試驗設計不同，但你們也進行了類固醇減量試驗，並同時研究了另外兩種適應症：視神經脊髓炎譜系障礙（NMOSD）和IgG4相關疾病。您能否談談您希望從數據中看到什麼，以及您預期會看到什麼？

Thank you, Yaron, for the question, and for following the program so closely. We're very excited about UPLIZNA, the CD19 B-cell depleting monoclonal antibody is showing really remarkable activity. The results in IgG4-related disease is a bellwether and is quite dramatic with a hazard ratio of 0.13, a p value of what, five to the minus seven. This was a stunning result and the first positive Phase 3 for patients with IgG4-related diseases.

感謝Yaron的提問，也感謝您對節目的密切關注。我們對UPLIZNA（一種CD19 B細胞清除單株抗體）的療效感到非常興奮，它展現了卓越的活性。在IgG4相關疾病的試驗結果具有里程碑意義，且結果非常顯著，風險比為0.13，p值為5的負7次方。這是一個令人震驚的結果，也是第一個針對IgG4相關疾病患者的陽性III期臨床試驗結果。

As you nicely picked up in your question, one of the opportunities of UPLIZNA is to get patients off steroids, and this is, therefore, a predefined ambition of UPLIZNA in both IgG4-related disease setting in that study as well, as in the generalized myasthenia gravis setting. Now these results won't be available until the second half of this year. And so I have no further update on that timing.

正如您在問題中提到的，UPLIZNA 的一個優勢在於幫助患者擺脫類固醇，因此，無論是在該研究中針對 IgG4 相關疾病，還是在全身型重症肌無力患者中，這都是 UPLIZNA 的預設目標。目前，這些結果要到今年下半年才能公佈，所以我暫時無法提供更多相關資訊。

But do stay tuned. We're so hopeful that this once every six months CD19 B-cell depleting therapy can differentiate substantially from available treatments like steroids and other B-cell targeting therapies and make a big difference for these patients.

但請繼續關注。我們非常希望這種每六個月一次的CD19 B細胞清除療法能夠與現有的類固醇和其他B細胞標靶療法有顯著區別，並為這些患者帶來巨大的改變。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good afternoon. Thanks for taking my question. Just following up here on Yaron's, could you speak to the clinical bar for UPLIZNA and myasthenia gravis, both on a placebo adjusted basis and also on an absolute basis, given the notable steroid taper, which I believe the other therapies did not have included in their design. And with regard to this MGFA scientific session meeting, should we expect top line results before that presentation?

午安.感謝您回答我的問題。關於Yaron的問題，我想進一步了解UPLIZNA治療重症肌無力的臨床療效，包括安慰劑校正後的療效和絕對療效，因為UPLIZNA需要逐漸減少類固醇用量，而其他療法的設計中似乎沒有考慮到這一點。另外，關於即將召開的MGFA科學會議，我們是否可以在會議報告之前看到初步結果？

Thank you.

謝謝。

Thanks, Salveen. As I just mentioned to Yaron. We won't be providing further guidance on the timing of the results from the UPLIZNA study, the MINT study in myasthenia gravis of that you stay tuned. And as also, as shared knowing that patients with myasthenia gravis are repeatedly and over many, many months of treatment challenge by the requirement for persistent steroids, we built in a taper steroids into this study. And these results to read out in the second half of this year will bring to light exactly how successful we are at liberating patients from steroids with every six months UPLIZNA.

謝謝，Salveen。正如我剛才跟Yaron所提到的，我們不會就UPLIZNA研究和MINT重症肌無力研究的結果公佈時間提供進一步的指導，請您繼續關注。此外，我們也知道重症肌無力患者在長達數月的治療過程中，長期需要服用類固醇，這給他們帶來了很大的挑戰，因此我們在這項研究中加入了類固醇減量方案。這些結果將於今年下半年公佈，屆時將揭示我們每六個月進行一次UPLIZNA治療，在幫助患者擺脫類固醇方面究竟取得了多大的成功。

Julianne, next question, please?

朱莉安娜，下一個問題好嗎？

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO資本市場。

Thank you so much for taking my question.

非常感謝您回答我的問題。

Well, not a huge growth driver. I'd love if you could characterize on some of your negotiations with CMS on Enbrel. Many of your peers are pleased with kind of the fair price that they negotiated with CMS. Do you feel the same way? I'd also love to know how you're seeing about the impact of Part D redesign?

嗯，這並非主要的成長動力。我很想聽聽您與CMS就恩利（Enbrel）進行的談判情況。您的許多同行都對他們與CMS談判達成的相對合理的價格感到滿意。您也有同樣的感受嗎？另外，我還想了解您如何看待D部分改革的影響？

Thank you so much.

太感謝了。

Thanks, Evan, for the question. It's Murdo here. Overall, Enbrel continues to do well in the market despite a very competitive market in psoriatic arthritis and in rheumatoid arthritis. We also continue to have relatively stable volume despite all of the conversion that's going on in adalimumab with biosimilars. So we're quite pleased with prescribers' adoption and continued value of Enbrel safety and tolerability, which is well established over a long period of time now in many, many years of experience.

謝謝Evan的提問。我是Murdo。整體而言，儘管乾癬性關節炎和類風濕性關節炎市場競爭激烈，恩利（Enbrel）的市場表現依然良好。此外，儘管阿達木單抗（adalimumab）的生物相似藥不斷湧現，我們的銷售量也保持相對穩定。因此，我們對處方醫生對恩利的接受度以及其安全性和耐受性的持續認可感到非常滿意。恩利的安全性和耐受性已透過多年的臨床實踐得到充分證實。

The process with CMS has concluded. We do have our price, I would just remind you that roughly 25% of Enbrel revenues come from Medicare Part D. So that will, in part, mitigate the impact of the CMS price reduction. And we continue to see that this is not a good mechanism to incentivize and reward innovation and it does not resemble one we've commonly described as a negotiation.

與CMS的流程已經結束。我們已經確定了價格，但我需要提醒各位，Enbrel約25%的收入來自Medicare Part D（聯邦醫療保險D部分）。因此，這將在一定程度上緩解CMS降價的影響。我們仍然認為，這種機制不利於激勵和獎勵創新，也與我們通常所說的談判截然不同。

So we've concluded that process. And we continue to look to help patients and support them with Enbrel in the market and we will watch the Part D redesign closely. We will look to see how PBMs redesign their formularies, and we will look to see how patients are impacted by the new model. While the cap may help, the out-of-pocket for many patients may actually rise. So we're watching it closely.

我們已經完成了這個流程。我們將繼續致力於幫助患者，並為他們提供市場上的恩利（Enbrel）產品，同時密切關注D部分醫保的重新設計。我們將觀察藥品福利管理機構（PBM）如何重新設計他們的藥品目錄，以及新模式對病人的影響。雖然價格上限可能有所幫助，但許多患者的自付費用實際上可能會增加。因此，我們正在密切關注事態發展。

Julianne, next question, please?

朱莉安娜，下一個問題好嗎？

Mike Yee, Jefferies.

Mike Yee，傑富瑞集團。

Thank you for the question.

謝謝你的提問。

Moving to obesity. I know that you are on track for data later this year for the injectable product, which you claim as differentiated as other competitors have moved quickly both with their programs with injectables, but also orals - multiple companies reported orals. Can you just comment about how you feel about your positioning in this space, given others have multiple products moving to late stage and how you feel you can position yourself here, given just 133. Thank you.

接下來談談肥胖症。我知道貴公司計劃在今年稍後公佈注射劑產品的相關數據，您聲稱該產品具有差異化優勢，因為其他競爭對手在註射劑和口服製劑方面都進展迅速——多家公司都公佈了口服製劑的數據。鑑於其他公司有多款產品進入後期研發階段，而貴公司目前只有133種產品，您如何看待貴公司在該領域的定位？謝謝。

Thanks, Mike. Why don't I get started and Murdo, perhaps you could add on at the end. We are very pleased with the results that we've seen at the interim with the overall conduct of the Phase 2 study. Though there's been no further analysis since the interim. As of the interim, all the arms were active, dropout had not been an issue, and we saw a differentiated profile with MariTide and remain confident that this medicine can address significant important unmet medical need in obesity, obesity-related conditions, and, in particular, Type 2 diabetes, as shared earlier in the call.

謝謝，麥克。不如我先開始，默多，你最後可以補充。我們對二期臨床試驗中期結果的整體進展非常滿意。雖然中期分析之後沒有進一步的分析。截至中期分析時，所有治療組均處於活躍狀態，受試者脫落率不高，而且我們觀察到MariTide展現出差異化的優勢，並仍然相信這種藥物能夠滿足肥胖症、肥胖相關疾病，尤其是2型糖尿病領域的重要未滿足醫療需求，正如我們在之前的電話會議中提到的那樣。

There's no question that there is quite a democratized and broad base of innovation in this space. And potentially oral medicines could serve to address some of that still vast and remaining unmet need, and we follow these programs very closely. Still, the development of MariTide is advancing very briskly, as we now move to rapidly initiate a broad Phase 3 program. And we remain confident in what MariTide can offer for patients with obesity-related conditions, as well as diabetes.

毫無疑問，該領域擁有相當普及且廣泛的創新基礎。口服藥物可望滿足部分仍未滿足的巨大需求，我們正密切關注這些項目。同時，MariTide 的研發進展迅速，我們正著手快速啟動一項廣泛的 III 期臨床試驗。我們對 MariTide 為肥胖相關疾病和糖尿病患者帶來的益處充滿信心。

Murdo?

默多？

Yes. Thanks, Jay. I think the data continue to emerge in the obesity and obesity-related conditions landscape, and show a clear benefit that reducing weight will indeed, with GLP-1-based mechanisms will indeed improve outcomes in many disease settings.

是的，謝謝傑伊。我認為在肥胖及相關疾病領域，不斷湧現的數據表明，透過GLP-1介導的機制減輕體重，確實能夠改善許多疾病的治療效果，這一點顯而易見。

So that continues to expand the market and grow it. I do agree with Jay that there will be patients who may seek oral options. But I continue to believe that we have a very good, differentiated product here and that monthly dosing or even less frequently will continue to help patients persist on their weight loss medication and achieve, hopefully, some of those hard endpoint risk reductions that we're seeing in clinical trial presentations.

因此，這將持續擴大市場並促進其成長。我同意傑伊的觀點，即有些患者可能會尋求口服藥物。但我仍然相信，我們擁有一款非常優秀且具有差異化的產品，每月一次甚至更低頻率的給藥方式將繼續幫助患者堅持服用減肥藥物，並有望實現我們在臨床試驗報告中看到的那些關鍵終點風險降低目標。

I would say that we would report that we have a really good convenient dosing here with a single-use pen that we're working on. And that weekly injectable products are probably more vulnerable to orals than convenient monthly dosing.

我想說的是，我們正在研發一種非常方便的單次使用注射筆。而且，每週注射一次的產品可能比每月一次的便捷給藥方式更容易受到口服藥物的衝擊。

Next question, please.

下一個問題。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

Thanks for taking my question. I wanted to focus on MariTide, if I may, a two-part question. First, it looks like your competitors are moving forward to Phase 3 on either smaller data sets or lesser further along from a Phase 2, Phase 3 perspective. Just curious why you thought you definitely needed 52-week data? Was that mostly conservatism? Or is that some FDA feedback as well?

感謝您回答我的問題。我想重點談談MariTide，如果可以的話，我想問兩個問題。首先，看起來您的競爭對手在數據量較小或從二期/三期臨床試驗的角度來看進展較慢的情況下，就已經進入了三期臨床試驗。我只是好奇您為什麼認為必須收集52週的資料？這主要是出於保守考量嗎？還是也受到了FDA的回饋？

And then also on CapEx, I feel like the $150 million guidance increase seems relatively trivial but it does imply CapEx being up 80% over first half. Could you please expand on whether it's API related or something else you have in mind?

另外，關於資本支出，我覺得1.5億美元的預期增幅看似微不足道，但這確實意味著資本支出比上半年增加了80%。您能否詳細說明一下，這是否與API相關，還是另有其他原因？

Yeah. Thanks. Pete, why don't I start on the overall development plan for MariTide and the value of the Phase 2 data that we'll have at the end of this year. Umer, as you know, this medicine coming out of Phase 1 showed a quite remarkable impact on obesity with a dramatic reduction in BMI. Actually proved quite durable after just three doses, MariTide in that Phase 1 study, we saw persistent weight loss really out 150 days or more at some doses.

是的，謝謝。皮特，不如我先談談MariTide的整體研發計劃，以及我們今年年底將獲得的二期臨床試驗數據的價值。烏默，如你所知，這種藥物在第一期臨床試驗中展現出對肥胖症的顯著療效，BMI值大幅下降。事實上，只需三次給藥，MariTide的療效就非常持久。在一期臨床試驗中，我們觀察到，在某些劑量下，體重減輕的效果甚至可以持續150天或更久。

The Phase 2 study is a much larger concern. This is a 592 patient study. It has 11 arms, it has monthly or as Murdo said, even less frequent dosing. As a part two that allows us to really follow up on this durability signal, and it will allow the precision selection of dose or doses that patients and their practitioners really desire. This also conforms to regulatory requirements entering into Phase 3.

二期研究更為重要。這項研究納入了592名患者，分為11個治療組，給藥頻率每月一次，甚至如默多所說，更低。作為第二階段研究，它使我們能夠真正跟進這種持久性信號，並能精準選擇患者及其醫生真正需要的劑量。這也符合進入三期研究的監管要求。

Umer, it's Peter on CapEx, as we previously indicated, we have initiated activities to further expand MariTide manufacturing capacity. So of course, those efforts, I said we now expect CapEx of $1.3 billion in '24 versus the most recent guidance, which was -- $1.1 billion to $1.2 billion.

Umer，我是Peter，關於資本支出，正如我們之前提到的，我們已經啟動了進一步擴大MariTide生產能力的活動。所以，當然，正如我所說，我們現在預計2024年的資本支出將達到13億美元，而先前的預期是11億至12億美元。

Next question, please.

下一個問題。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Hey, thanks for taking the question. And congrats on all the progress, especially in your BiTE platform. Can you talk about any feedback you're getting from clinicians on the IMDELLTRA launch and potential lessons learned from BLINCYTO that you can leverage for IMDELLTRA, especially since you're launching BLINCYTO now in B-ALL and developing a SubQ formulation? Thank you

您好，感謝您回答這個問題。恭喜您取得的所有進展，尤其是在BiTE平台方面。您能否談談從臨床醫生那裡收到的關於IMDELLTRA上市的反饋，以及從BLINCYTO中汲取的經驗教訓可以藉鑑到IMDELLTRA中，特別是考慮到您現在正在將BLINCYTO應用於B-ALL治療，並且正在開發皮下製劑？謝謝！

Take it in a couple of parts here. Murdo, do you want to share what we're learning from the launch?

先分幾部分來說。默多，你想分享我們從這次發表會中學到了什麼嗎？

Yeah. Thanks for the question, Jay. Obviously, it's very early given that this was a mid-May approval but I have to say we are extremely pleased with how both thought leaders and community oncologists are receiving IMDELLTRA in the market.

是的，謝謝你的提問，Jay。顯然，鑑於這是五月中旬才獲批的藥物，現在下結論還為時過早，但我必須說，我們對IMDELLTRA在市場上的反響，無論是行業領袖還是普通腫瘤醫生，都給予了非常積極的評價，我們感到非常滿意。

Their clinical conviction is very high. They are moving quickly to establish care pathways for these patients given the monitoring requirement for IMDELLTRA. And this is -- this disease setting, as you know, is a really difficult disease setting. Patients can progress relatively rapidly after platinum-based chemotherapy in the front line.

他們的臨床信心非常高。鑑於IMDELLTRA的監測要求，他們正在迅速建立這些患者的治療路徑。而且，如您所知，這種疾病的治療環境非常棘手。患者在接受第一線鉑類化療後，病情進展可能相對較快。

And so we're obviously moving very quickly with our medical teams, our account management teams and our sales organization to build rapid awareness and to help both academic and community oncology accounts, be able to treat patients easily and safely and have the appropriate settings for care follow-up. So very early, but this product is seen as a major transformation in this disease setting. Jay?

因此，我們顯然正與醫療團隊、客戶管理團隊和銷售團隊迅速合作，快速提升產品認知度，並幫助學術界和社區腫瘤科能夠更便捷、安全地治療患者，並為其提供合適的後續護理環境。雖然目前還處於早期階段，但這款產品被視為該疾病治療領域的重大變革。傑伊？

Yeah. Thanks for the question, Jay. You picked up on something really interesting and that's leveraging the learnings of BLINCYTO. I mean this really is a platform capability that we enjoy with bispecific T-cell engagers.

是的，謝謝你的提問，Jay。你抓住了一個非常有趣的點，那就是如何利用BLINCYTO的經驗。我的意思是，這確實是我們利用雙特異性T細胞銜接器所擁有的平台優勢。

And already in the development of IMDELLTRA after its first approval, we are seeing significant readthrough of the BLINCYTO lessons, moving from later lines of therapy to earlier lines of therapy, to drive efficacy in the setting of reduced tumor burden.

在 IMDELLTRA 首次核准後的研發過程中，我們已經看到 BLINCYTO 的經驗教訓得到了顯著的借鑒，從後期治療轉向早期治療，以提高在腫瘤負荷降低的情況下的療效。

The utility of these medicines in combination, which is so much easier to access and assess than other complex modalities, say, like CAR-T, and moving these medicines to the point of therapy where they can have the greatest impact, namely frontline, also pathways to reduce monitoring.

這些藥物聯合使用的效用，比其他複雜的療法（例如 CAR-T 療法）更容易獲得和評估，並將這些藥物推向治療的關鍵點，即一線治療，以發揮其最大的作用，同時也是減少監測的途徑。

Jay, we are leveraging all the learnings of BLINCYTO to drive and expedite the development of IMDELLTRA to be a component of frontline small cell lung cancer therapy, both with extensive stage and limited stage disease. And as Murdo shared, we do this work really quite inspired by the impact of the medicine, even so early in its launch, significant demand to learn and access and offer this medicine.

傑伊，我們正在充分利用BLINCYTO計畫的所有經驗，推動並加速IMDELLTRA的研發，使其成為一線小細胞肺癌治療方案的一部分，適用於廣泛期和局限期患者。正如默多所說，我們進行這項工作的動力很大程度上來自於這種藥物的影響力，即使在上市初期，人們對了解、取得和使用這種藥物的需求也十分旺盛。

And Jay, I'd just add that when it comes to xaluritamig, I think you're question applies well there, too. So stay tuned. We'll talk more about xaluritamig's data emerge but we're optimistic about how we can apply the lessons of BLIN and IMDELLTRA to that as well.

傑伊，我還要補充一點，關於沙魯瑞米格，我認為你的問題也同樣適用。敬請期待。我們會進一步討論沙魯瑞米格的數據，但我們對如何將BLIN和IMDELLTRA的經驗應用在沙魯瑞米格上持樂觀態度。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Great. Thank you very much for taking my question. I have a question for Jay. Again, on MariTide. Is there any reason to think that MariTide may or may not exhibit a different profile versus Wegovy or Zepbound on parameters such as lipids, blood pressure, or C reactive protein? And how important is benefit on those parameters while you design your Phase 3 trial, something like outcomes trial or not?

太好了。非常感謝您回答我的問題。我還有一個問題想問Jay，還是關於MariTide。 MariTide在血脂、血壓或C反應蛋白等參數方面，與Wegovy或Zepbound相比，是否有任何可能表現出不同的特徵？在設計第三期臨床試驗（無論是療效試驗或其他類型的試驗）時，這些參數的效益有多重要？

Thank you.

謝謝。

Yeah. Thank you, Mohit. I can surely understand the interest. And indeed, we are making all these measurements and more. We won't dimensionalize what we mean when we say differentiated profile at this time. We're so focused on completing this ongoing and well-conducted MariTide Phase 2 study but do expect to learn and this and more when ultimately we're able to be in a position to share the outcomes of Part A of the Phase 2 study. We are taking a comprehensive assessment to optimize dose and schedule and impact of this medicine.

是的，謝謝你，莫希特。我完全理解你的關注。的確，我們正在進行所有這些測量，以及更多其他測量。目前我們不會詳細解釋「差異化特徵」的具體意義。我們正全力以赴完成這項正在進行且執行良好的MariTide二期臨床試驗，但預計在最終能夠分享二期臨床試驗A部分的結果時，我們會了解到更多資訊。我們正在進行全面的評估，以優化該藥物的劑量、給藥方案和療效。

Gregory Renza, RBC Capital Markets.

格雷戈里·倫扎，加拿大皇家銀行資本市場。

Great. Thanks. Congratulations on the quarter. My question is just on the obesity franchise. As you and the team had mentioned to expect one of the early obesity programs to enter clinical development later this year. Just curious if you could elaborate on what lens you're using to nominate that first or that next program? I'd imagine it's rather complex in the assessment and any color you have on determining that choice and how to take that forward, would be great.

太好了，謝謝。恭喜你們本季業績出色。我的問題是關於肥胖症的方面。正如您和您的團隊之前提到的，預計今年稍後會有一個早期肥胖症計畫進入臨床開發階段。我想問一下，您是如何選擇第一個或下一個專案的？我想評估過程應該相當複雜，如果您對如何做出選擇以及如何推進專案有任何見解，那就太好了。

Gregory. Thank you. This is Jay, and thanks for following the early pipeline in its development. It's developing very nicely. As we've shared our strategy in the development of obesity medicines and medicines for obesity-related conditions. We're interested in really harvesting the insights of the incretin pathway but also moving beyond this pathway to other novel targets, some supported by genetic inferences but all of them supported by strong preclinical development packages.

格雷戈里：謝謝。我是傑伊，感謝您關注我們早期研發管線的進度。目前進展非常順利。正如我們先前分享的，我們在肥胖症藥物及相關疾病藥物的研發策略方面，不僅致力於深入挖掘腸促胰島素通路，還希望將研究拓展到其他新的靶點，其中一些靶點已通過基因推斷得到驗證，但所有靶點都擁有強大的臨床前研發支持。

And so it is a multifactorial assessment that leads to the decision to resource the medicine in human clinical investigation. But it's a high degree of conviction that's required as the bars are ever rising within our portfolio for that resource as well as in the field. So more to follow on the mechanism and characteristics of this new medicine that we're intending to advance in the clinical investigation in the second half of this year.

因此，是否將該藥物投入人體臨床試驗是一個綜合多因素評估的決定。但這需要高度的信心，因為我們自身產品組合以及整個領域對這類藥物的需求都在不斷提高。關於這種新藥的作用機轉和特性，我們將在今年下半年推進臨床試驗，敬請期待後續報導。

Next question, please.

下一個問題。

Chris Raymond, Piper Sandler.

克里斯·雷蒙德，派珀·桑德勒。

Thanks. And if I may, another obesity question. Just on MariTide, and I've heard you guys now talk for a long time about planning for a broad Phase 3 program. But I don't think you guys have ever talked even in generalities, when exactly this will happen. Can you maybe give a range here for when you anticipate kicking off enrollment in that program?

謝謝。如果可以的話，我還有一個關於肥胖的問題。我剛在MariTide論壇上看到你們一直在討論第三階段的計劃，但似乎你們從未具體說明過何時啟動。能否大概說明一下，你們預計何時開始招募新成員？

Chris, as you can expect, we're focused now on completing the Phase 2 trial and moving as swiftly as appropriate into Phase 3. So we'll have more to say that over the course of the coming year. You can appreciate it's a competitively intense field. So we're not giving dates at this point.

克里斯，正如你所料，我們現在的重點是完成第二期臨床試驗，並儘快進入第三期臨床試驗。所以，未來一年我們會公佈更多資訊。你也知道，這是一個競爭非常激烈的領域，所以我們目前還不能給出具體日期。

Next question, please.

下一個問題。

Carter Gould, Barclays.

Carter Gould，巴克萊銀行。

Good afternoon. Thank you for taking the question. For Peter, on August 2, the U.S. Tax Court entered a decision against Coke. Their litigation was often referenced as sort of the best benchmark for sort of what you're facing. Appreciating that you took the deposit earlier this year but why shouldn't there be read through from that case? And maybe you could speak to your overall confidence in the outcome?

午安.感謝您回答這個問題。彼得，8月2日，美國稅務法院對可口可樂公司作出了不利裁決。他們的訴訟案經常被認為是您目前面臨的類似情況的最佳參考案例。我知道您今年早些時候已經收取了保證金，但為什麼不能藉鑑該案的經驗呢？您能否談談您對最終結果的整體信心？

No. Thank you very much for the question, Carter. Nothing has changed in our evaluation of the case. Court dates set for November 4. We're confident in our position, right, where we've always been. We're confident in our reserves are at an appropriate level. And what I would say is, first of all, I don't see -- and Coke hasn't been as much a reference and I won't get into making comparisons.

不，非常感謝你的提問，卡特。我們對這起案件的評估沒有任何改變。庭審日期定於11月4日。我們對自己的立場充滿信心，一如既往。我們對儲備金處於適當水平充滿信心。我想說的是，首先，我不認為──可口可樂並不是一個重要的參考對象，我不想做比較。

We refer once in a while to the Medtronic situation. But in general, what we've seen is that the tax court in the last several years has reinforced the value of manufacturing down in Puerto Rico. And so we look forward to stating our case. We're very confident where we're at. And that's all we've got to say at this time. No change. We're at where we were in terms of confidence, which is in the same place for the last 2.5 or 3 years now.

我們偶爾會提及美敦力公司的情況。但總的來說，我們看到，過去幾年稅務法庭的裁決​​強化了波多黎各製造業的價值。因此，我們期待陳述我們的觀點。我們對目前的處境非常有信心。這就是我們目前要說的全部。沒有任何改變。我們的信心與過去兩三年來一直保持的水平相同。

Next question, please.

下一個問題。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

Great. Thanks for taking the question. Peter, another one for you here. I appreciate the incremental guidance on CapEx, but just was wondering if you could speak directionally about margins in 2025, given the likely scope of the MariTide obesity program.

太好了。謝謝你回答這個問題。彼得，我還有一個問題想問你。我很感謝你對資本支出的逐步指導，但考慮到MariTide肥胖症防治計畫的規模，我想請你談談2025年的利潤率預期。

Terence, we don't as you know, we don't guide long-term margins, but let me just comment on what you're seeing this year. I'm happy to speak to that. And I think it's important. We're -- at Amgen, we're committed to a capital allocation hierarchy, where we first invest in innovation and first internal innovation. And so with that in mind, Terence, we've consistently said that we would flex Op margin, which remember, with us, as a percentage of product sales, not revenue, if there were opportunities to achieve strong after-tax cash returns on our investment in excess of our hurdle rate. And then we would communicate that ahead of time.

特倫斯，正如你所知，我們不設定長期利潤率目標，但我想就今年看到的情況談談我的看法。我很樂意分享，我認為這很重要。在安進，我們致力於資本配置的優先順序，優先投資於創新，尤其是內部創新。因此，特倫斯，我們一直強調，如果投資能夠帶來超過預期回報率的強勁稅後現金回報，我們會靈活調整營運利潤率（請記住，在我們這裡，營運利潤率是產品銷售額的百分比，而不是收入的百分比）。我們會提前與大家溝通。

So this year, we shared with you at the beginning of the year, we felt operating margin to be about 48%. We see an opportunity here during the year to make some investments in the research and development activities with an emphasis, I would say, on development. That's up 30% year-over-year in the quarter, non-GAAP R&D.

今年年初，我們曾向大家預測，營業利益率約48%。我們認為今年有機會加大研發投入，重點應放在研發方面。本季非GAAP研發投入年增30%。

We now see non-GAAP R&D spend up over 25% year-over-year for '24, which we think is great because you've heard about the deep mid- and late-stage pipeline we have, driving MariTide in that deep mid- and late-stage pipeline. We're always focused Terence, whether it's this year or next year on productivity and prioritization, always looking for opportunities to generate capital to allocate the innovation.

我們現在看到，2024年非GAAP研發支出年增超過25%，我們認為這非常好，因為您已經了解我們擁有豐富的在研中後期產品線，而MariTide正是這些產品線中的重要一環。 Terence，無論今年或明年，我們始終專注於提高效率和優化優先級，並不斷尋找機會籌集資金，以支持創新。

We've got a new program called technology and workforce strategy that we're moving along at speed and scale. I spoke about opening a new talent and innovation center in Hyderabad, India. So we are doing everything we can to preserve that margin, reallocate capital innovation and be the disciplined spenders of capital that Amgen always has been.

我們正在快速推進一項名為「技術和勞動力策略」的新計劃。我之前提到在印度海得拉巴開設一個新的人才和創新中心。因此，我們正在竭盡全力保持利潤率，重新分配資本用於創新，並像安進一直以來那樣，嚴格控制資本支出。

Next question, please.

下一個問題。

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

Great. Thanks very much. Just had a question on MariTide and your plans in that Phase 2 diabetes study. Company, obviously, very excited about the broader opportunity for the drug but it does seem like diabetes is a more established market with maybe less of the capacity constraints than we've see in obesity.

太好了，非常感謝。我有一個關於MariTide以及你們二期糖尿病研究計劃的問題。該公司顯然對這款藥物的更廣泛應用前景感到非常興奮，但糖尿病市場似乎比肥胖症市場更加成熟，產能限制可能更少。

So can you just talk a little bit about what you think you need to see to be able to compete here in dislodging incumbents? And can you also confirm that the study is not needed to move forward in the Phase 3 obesity studies, or it's just a completely separate program related to the diabetes piece of things?

那麼，您能否簡單談談您認為需要看到哪些方面才能在競爭中勝出，撼動現有競爭對手的地位？您能否也確認一下，這項研究並非推動第三期肥胖症研究的必要條件，還是它只是一個與糖尿病相關的完全獨立的項目？

Can take this in two pieces again. Jay, why don't you address the first piece and then Murdo feel free to jump in.

可以再分成兩部分來討論。傑伊，你先說第一部分，然後默多再補充。

Yes, absolutely. As you nicely identified later this year, we will initiate an additional dedicated Phase 2 study that will characterize MariTide from the treatment of diabetes in patients with and without obesity. And this new study is not a gating step at all for the Phase 3 program for patients with obesity, but conforms to regulatory guidance and importantly, allows us to optimize dosing for the diabetic patients, where medically, I can say your considerable perspective, I'm unaware of a highly efficacious monthly or less frequently administered medicine for the treatment of diabetes. Murdo?

是的，當然。正如您在今年稍後提到的，我們將啟動一項額外的專案二期臨床試驗，旨在評估 MariTide 在治療肥胖和非肥胖糖尿病患者方面的療效。這項新研究並非針對肥胖患者的第三期臨床試驗的先決條件，而是符合監管指南，更重要的是，它能幫助我們優化糖尿病患者的用藥方案。就醫學而言，依您淵博的學識，我目前還沒有發現任何一種療效顯著、每月或更少給藥頻率的糖尿病治療藥物。您說得對嗎？

Yeah. Thanks, Jay. I would agree with you that the differentiation that we've talked about for chronic weight management would hold in a robust way in Type 2 diabetes. And while there are lots of products that can control hyperglycemia and provided HbA1c control, there is a significant benefit if you can improve adherence and persistence. And we do believe that our monthly dosing could do that.

是的，謝謝傑伊。我同意你的觀點，我們之前討論的針對慢性體重管理的差異化策略同樣適用於第2型糖尿病。雖然有許多產品可以控制高血糖和糖化血紅蛋白（HbA1c）水平，但如果能提高患者的依從性和堅持性，效果會更加顯著。我們相信，我們的每月給藥方案可以做到這一點。

Next question, please Julianne?

朱莉安娜，請問下一個問題？

Kripa Devarakonda, Truist Securities.

Kripa Devarakonda，Truist 證券公司。

Thank you so much for taking my question. Another obesity question but slightly tangential. I'm not sure if you've talked about this before but there's been a conversation about muscle preservation in people who are losing weight on GLP. Have you evaluated this aspect with MariTide? Do you see this being the problem broadly in the space? And if so, where do you think MariTide would fit into that landscape?

非常感謝您回答我的問題。還有一個關於肥胖的問題，不過有點離題。我不知道您之前是否討論過，但最近有討論指出，服用 GLP 減肥的人在肌肉保留方面存在問題。您是否評估過 MariTide 在這方面的表現？您認為這是整個領域普遍存在的問題嗎？如果是的話，您認為 MariTide 應該如何定位？

Thank you.

謝謝。

Sure. Jay, why don't you jump in there?

當然。傑伊，你為什麼不加入呢？

Sure. Thank you for your question. We -- as you apparently do as well, are following this class and class of medicines that provoke remarkable weight loss or the impact on healthy tissues, including but not limited to muscle, and the associated muscle loss that has been reported in the literature may relate mechanistically and may also relate to the quite dramatic cadence of weight loss of patients treated with these medicines. And in the fullness of time, we and others will have that answer.

當然。謝謝你的提問。我們——顯然你也是一樣——正在關注這類藥物，它們會引起顯著的體重減輕或對健康組織（包括但不限於肌肉）產生影響。文獻中所通報的肌肉流失可能與藥物的作用機轉有關，也可能與服用這些藥物的患者體重快速下降的現像有關。假以時日，我們和其他人都會找到答案。

As you can imagine, we're making many of these measurements on our own study and don't have any report any data to report to you here today but we too are following this. And also the progress of some organizations that are seeking to administer medicine to support muscle loss with obesity medicines that is quite interesting to us given our legacy of muscle biology. But I would say these are early insights from the field. To my knowledge, they have not proven has yet to be debilitating to the patient but we like you follow with interest.

正如您所想，我們正在自己的研究中進行許多此類測量，今天沒有任何數據可以向您匯報，但我們也密切關注此事。此外，一些機構正在嘗試使用藥物來緩解肥胖症患者的肌肉流失，鑑於我們在肌肉生物學領域的深厚造詣，我們對此也頗感興趣。但我認為這些只是該領域的初步發現。據我所知，目前尚未證實這些藥物會對患者造成損害，但我們和您一樣，對此保持著濃厚的興趣。

Julianne saying we're getting to the top half of the hour here. Maybe we'll just take two more questions.

朱莉安娜說，現在已經快到半小時了。也許我們可以再回答兩個問題。

James Shin, Deutsche Bank.

James Shin，德意志銀行。

Hi, guys. Thanks for taking my question. For the next obesity asset that's entering clinics later this year, can you specify whether this asset is aimed to fill in for '786, and whether this next obesity asset will work in tandem with 133?

大家好。感謝你們回答我的問題。關於今年稍後即將進入臨床應用的下一款肥胖症治療產品，能否說明一下這款產品是否旨在替代“786”，以及這款新的肥胖症治療產品是否會與“133”協同使用？

Thanks, James. We won't today provide any further insight into this medicine. It's just too early. And as Bob shared, this is nicely for patients, a very competitive space. But as I shared earlier, in our deeper pipeline in obesity, we remain interested in the incretin pathway.

謝謝，詹姆斯。今天我們不會透露更多關於這種藥物的信息，現在下結論還為時過早。正如鮑伯所說，這對患者來說是一個競爭非常激烈的領域。但正如我之前提到的，在我們針對肥胖症的更深層的研發管線中，我們仍然對腸促胰島素路徑很感興趣。

We remain interested in injectable. We're also pursuing oral medicines. And so in the fullness of time, we'll have a chance to share more. We're really playing the long game to drive true differentiation benefits to the patient and to access segments of the market that are not well addressed even by the current medicines.

我們仍然對注射劑感興趣。我們也積極研發口服藥物。因此，時機成熟時，我們將有機會分享更多資訊。我們著眼長遠，力求為患者帶來真正的差異化優勢，並開拓現有藥物尚未充分覆蓋的市場領域。

Gary Nachman, Raymond James.

Gary Nachman，Raymond James。

Okay. Thanks, good afternoon. So shifting to TEPEZZA. When do you think we'll see more of an acceleration in the low CAS patients? How has reimbursement been improving for those patients? And describe how much the Japanese opportunity could help next year?

好的，謝謝，下午好。接下來我們聊聊TEPEZZA。您認為低CAS評分患者的成長速度何時會加速？這些患者的報銷情況如何改善？日本市場的機會明年能起到多大作用？

And then just talk about the overall resources you're putting behind TEPEZZA and the rest of the rare disease portfolio that obviously, a much bigger focus for you now, if that continues to ramp up at what pace and when you might get more operating leverage from that rare disease business?

然後談談您在 TEPEZZA 以及其他罕見疾病產品組合上投入的整體資源，顯然，這現在是您更關注的重點。如果這些資源持續成長，您將以怎樣的速度成長？何時您才能從罕見疾病業務中獲得更多營運槓桿？

Thank you.

謝謝。

A lot of questions there, Gary, but why don't we take it in a couple of pieces. Go ahead, Vikram.

問題很多，加里，我們不妨分成幾個部分來討論。維克拉姆，請講。

Yes. So thanks for the question, Gary. Look, we're pretty pleased with how we've been executing on TEPEZZA this year and driving it towards growth. As you rightly observed, there are a significant number of low CAS patients or low clinical activity score patients that are suffering from this disease who are not being appropriately treated. And specifically, that's about 80,000 out of the 100,000 addressable patients in the US.

是的。謝謝你的提問，Gary。你看，我們對今年TEPEZZA的執行情況以及推動其成長的進展非常滿意。正如你所指出的，有相當一部分CAS評分低或臨床活動評分低的患者患有這種疾病，卻沒有得到適當的治療。具體來說，在美國10萬名潛在患者中，大約有8萬名患者沒有得到適當的治療。

What we have been doing is seeing significant momentum on expanding our prescriber base, which now in addition to oculoplastic surgeons, also includes ophthalmologists and endocrinologists. And this is a really important element here. The strategic focus in endocrinology is really important so that we can serve those low CAS patients, the low CAS patients favorably.

我們一直在努力擴大處方醫生群體，目前除了眼整形外科醫生外，還包括眼科醫生和內分泌科醫生，並取得了顯著進展。這一點至關重要。我們尤其重視內分泌科，以便更好地服務那些臨床活動度較低的患者。

You asked about improving access. To date, we have achieved favorable medical policy changes for greater than 65% of US covered lives. And if you compare that to 50% last quarter and just over 5% about a year ago, I think we've made pretty good progress in enabling patient access using our Phase IV data that have become available last year.

您問到如何改善醫療服務可近性。迄今為止，我們已為超過65%的美國投保人員爭取到了有利的醫療政策調整。與上季的50%和大約一年前的略高於5%相比，我認為我們利用去年公佈的四期臨床試驗數據，在提升患者就醫便利性方面取得了相當不錯的進展。

So we continue to see a significant growth opportunity for TEPEZZA in the US while also recognizing that as we make progress with a lot of our execution efforts, there continues to be a time lag between when we knock down barriers for access, expand our prescriber base, and see patients get on therapy.

因此，我們繼續看到 TEPEZZA 在美國具有巨大的成長機會，同時也認識到，儘管我們在執行方面取得了許多進展，但在我們消除准入障礙、擴大處方醫生群體和看到患者接受治療之間仍然存在時間滯後。

In Japan, Gary, we expect that they'll be, again, an attractive market and this will be well received in that country, and we'll talk about that once we've launched there during the course of next year. With respect to leverage, I think I would just offer that we're on track. With respect to our synergy targets there, and we'll begin to get even more leverage as we're able to take full control of the supply chain for the rare disease products.

加里，我們預期日本市場依然極具吸引力，我們的產品在日本會受到歡迎。明年產品在日本上市後，我們會詳細討論這個問題。至於槓桿效應，我認為我們目前進展順利。就我們的綜效目標而言，隨著我們能夠全面掌控罕見疾病產品的供應鏈，我們將獲得更大的槓桿效應。

And then I would just further observe, as we've said many times, that feel fortunate that there's a good overlap between some of our existing capabilities in sales and marketing and the needs of those rare disease products. So all in all, we remain really excited about what we're able to do for rare disease patients, the position we have, and the likelihood of that just improving over time. So with that, let me thank all of you. I know we've gone a few minutes over the set time but thank you all for participating in the call, and we look forward to regrouping with you after the third quarter. Thanks.

然後，我想補充一點，正如我們多次提到的，我們很幸運，我們現有的銷售和行銷能力與這些罕見疾病產品的需求有很好的契合度。總而言之，我們對能夠為罕見疾病患者所做的一切、我們目前的地位以及未來發展的可能性感到非常興奮。最後，我要感謝各位。我知道我們超時了幾分鐘，但還是要感謝大家參加這次電話會議，我們期待在第三季結束後與大家再次相聚。謝謝。