美國安進 (AMGN) 2024 Q3 法說會逐字稿

My name is Julianne, and I will be your conference facilitator today for Amgen's third-quarter 2024 financial results conference call. (Operator Instructions)

我叫朱莉安娜，今天我將擔任安進 2024 年第三季財務業績電話會議的會議主持人。 （操作員說明）

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

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

Thank you, Julianne. Good afternoon, everyone, and welcome to our third-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.

謝謝你，茱麗安。大家下午好，歡迎參加我們的 2024 年第三季財報電話會議。鮑勃·布拉德威(Bob Bradway) 將主持電話會議，隨後默多·戈登(Murdo Gordon)、維克拉姆·卡納尼(Vikram Karnani)、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審查。

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.

在今天的討論過程中，我們將使用非公認會計準則財務指標來描述我們的業績，並在本次電話會議隨附的資料中提供適當的調節。我們還將做出一些前瞻性聲明，這些聲明符合我們的安全港聲明，請注意，實際結果可能會有重大差異。

Over to you, Bob.

交給你了，鮑伯。

Thank you for joining us today. Our performance this quarter reflects the strength of our business across our core therapeutic areas and geographies. Our in-market medicines performed well in the quarter with third-quarter revenues up 23% to $8.5 billion and 10 of our products delivering double-digit or better sales growth. We're also rapidly advancing our pipeline with a significant number of potentially first-in-class or best-in-class medicines positioning us for long-term growth.

感謝您今天加入我們。我們本季的業績反映了我們在核心治療領域和地區的業務實力。我們的市場藥品在本季表現良好，第三季營收成長 23%，達到 85 億美元，我們的 10 個產品實現了兩位數或更高的銷售成長。我們也正在快速推進我們的產品線，推出大量潛在的一流或一流藥物，使我們能夠實現長期成長。

Let me address MariTide directly. Our ongoing Phase 2 study is progressing well, and we look forward to sharing results later this year. We're well advanced in preparing to launch a broad Phase 3 program for MariTide, including obesity, obesity-related conditions, and type 2 diabetes.

讓我直接向 MariTide 講話。我們正在進行的第二階段研究進展順利，我們期待在今年稍後分享結果。我們在準備啟動 MariTide 廣泛的第 3 階段計劃方面進展順利，其中包括肥胖、肥胖相關疾病和 2 型糖尿病。

You may have noted that we recently initiated a Phase 2 study in patients with type 2 diabetes. As we shared after the interim analysis, we're confident that MariTide's differentiated profile will address important unmet medical needs across a number of diseases, including type 2 diabetes.

您可能已經注意到，我們最近針對第 2 型糖尿病患者啟動了一項第 2 期研究。正如我們在中期分析後分享的那樣，我們相信 MariTide 的差異化形象將解決包括 2 型糖尿病在內的多種疾病中未被滿足的重要醫療需求。

Beyond obesity, we have momentum across each of our therapeutic areas, and I'll start with oncology. In the third quarter, we saw strong in-market performance with 17% sales growth across the innovative oncology portfolio and several products experienced double-digit growth, including BLINCYTO, which, of course, is our first bispecific T-cell engager or BiTE, which is now established as the standard of care in B-cell acute lymphoblastic leukemia.

除了肥胖之外，我們在每個治療領域都有動力，我將從腫瘤學開始。第三季度，我們看到了強勁的市場表現，整個創新腫瘤產品組合的銷售額增長了17%，並且一些產品經歷了兩位數的增長，其中包括BLINCYTO，當然，它是我們的第一個雙特異性T 細胞接合器或BiTE，目前已確立為 B 細胞急性淋巴性白血病的護理標準。

The launch of our next BiTE, IMDELLTRA, is also progressing well, with strong clinical conviction and three Phase 3 studies underway in small cell lung cancer. And further demonstrating the strength and promise of this platform in solid tumors, we're pleased to announce today that we will advance xaluritamig into Phase 3 clinical development in advanced prostate cancer in the fourth quarter. Let me remind you to also keep an eye out for Phase 3 bemarituzumab data in gastric cancer, which we should have in the next few months.

我們的下一款​​ BiTE IMDELLTRA 的推出也進展順利，具有強大的臨床說服力，並且正在進行三項針對小細胞肺癌的 3 期研究。為了進一步證明該平台在實體瘤方面的實力和前景，我們今天很高興地宣布，我們將在第四季度將 xaluritamig 推進到晚期前列腺癌的 3 期臨床開發。讓我提醒您也要留意胃癌的 3 期 bemarituzumab 數據，我們應該在接下來的幾個月內獲得這些數據。

Our rare disease portfolio delivered $1.2 billion of sales in the quarter, growing 21% year over year, driven by TEPEZZA, KRYSTEXXA, UPLIZNA, and TAVNEOS. These medicines are highly innovative, are still in the early stages of their life cycles, and have significant upside potential, including expansion into new indications and geographies. For example, TEPEZZA was recently approved in Japan.

在 TEPEZZA、KRYSTEXXA、UPLIZNA 和 TAVNEOS 的推動下，我們的罕見疾病產品組合本季銷售額達 12 億美元，年成長 21%。這些藥物具有高度創新性，仍處於生命週期的早期階段，並且具有巨大的上升潛力，包括擴展到新的適應症和地理。例如，TEPEZZA 最近在日本獲得批准。

Also in rare disease, UPLIZNA demonstrated compelling data in generalized myasthenia gravis and was granted breakthrough therapy designation in IgG4-related diseases. We're excited about the promise of inebilizumab in these settings and potentially in other B cell-mediated autoimmune diseases.

同樣在罕見疾病方面，UPLIZNA 在全身性重症肌無力方面展示了令人信服的數據，並獲得了 IgG4 相關疾病的突破性治療指定。我們對 inebilizumab 在這些情況以及可能在其他 B 細胞介導的自身免疫性疾病中的前景感到興奮。

In inflammation, TEZSPIRE continues its strong trajectory with 67% growth year-over-year in the quarter. We're further encouraged by the potential of TEZSPIRE in COPD and additional indications that we're also actively exploring.

在發炎領域，TEZSPIRE 繼續保持強勁勢頭，本季年增 67%。 TEZSPIRE 在慢性阻塞性肺病方面的潛力以及我們也在積極探索的其他跡象進一步鼓舞了我們。

And finally, in general medicine, Repatha and EVENITY are each delivering strong volume growth again this quarter. These products are pivotal as we continue to serve more patients and meet the growing demand for therapies that address some of the most serious health challenges worldwide like heart disease and osteoporosis.

最後，在普通醫學領域，Repatha 和 EVENITY 本季再次實現強勁的銷售成長。這些產品對於我們繼續為更多患者提供服務並滿足對解決心臟病和骨質疏鬆症等全球一些最嚴重的健康挑戰的療法日益增長的需求至關重要。

Looking ahead, we remain confident that Amgen is well positioned to deliver long-term growth and innovation across each of our therapeutic areas. Our balanced portfolio, combined with the strength of our pipeline, we think will continue to drive our business forward.

展望未來，我們仍然相信安進處於有利地位，能夠在我們的每個治療領域實現長期成長和創新。我們認為，我們均衡的產品組合，加上我們產品線的實力，將繼續推動我們的業務向前發展。

As always, I'd like to thank my colleagues across Amgen for their unwavering commitment to patients. And I want to now turn the call over to Murdo.

一如既往，我要感謝安進公司的同事們對病人堅定不移的承諾。我現在想把電話轉給默多。

Thanks, Bob. Execution was strong across our core therapeutic areas in the third quarter, driving 24% year-over-year product sales growth. Each of our regions delivered double-digit volume growth. And sales of 10 products grew by double digits or better, including Repatha, TEZSPIRE, BLINCYTO, EVENITY and TAVNEOS, all brands that are important to our future growth trajectory.

謝謝，鮑伯。第三季我們的核心治療領域執行力強勁，推動產品銷售年增 24%。我們每個地區的銷量都實現了兩位數的成長。 10 個產品的銷售額實現了兩位數或更高的成長，包括 Repatha、TEZSPIRE、BLINCYTO、EVENITY 和 TAVNEOS，所有品牌對我們未來的成長軌跡都很重要。

Starting with our general medicine portfolio, sales of Repatha, EVENITY, and Prolia collectively grew 18% year over year in the third quarter, driven by volume growth. We serve large patient populations with these therapies. For example, we expect Repatha and Prolia alone will help over 11 million patients in 2024.

從我們的普通藥品產品組合開始，在銷售成長的推動下，Repatha、EVENITY 和 Prolia 第三季的銷售額年增了 18%。我們為大量患者提供這些療法。例如，我們預計 2024 年僅 Repatha 和 Prolia 就能幫助超過 1,100 萬名患者。

Repatha sales increased 40% year over year to $567 million for the third quarter, now annualizing at over $2 billion in sales. In the quarter, we saw year-over-year volume growth of 41% and favorable changes to estimated sales deductions of 8%, partially offset by lower net selling price of 10%.

第三季 Repatha 銷售額年增 40%，達到 5.67 億美元，目前年銷售額超過 20 億美元。本季度，銷量年增 41%，預計銷售扣除額出現 8% 的有利變化，但淨售價下降 10% 部分抵消了這一變化。

In the US, our expanded primary care field force efforts drove a 50% year-over-year increase in primary care physician prescribers. US volume growth was enabled by broad reimbursement and removal of prior authorization requirements by several payers. Outside the US, Repatha retains category leadership and continues to grow across major markets despite increased competition in the segment. EVENITY sales increased 30% year over year to almost $400 million for the third quarter.

在美國，我們擴大初級保健現場隊伍的努力推動初級保健醫生開處方的人數同比增加了 50%。美國銷售量的成長得益於多個付款人的廣泛報銷和取消事先授權要求。在美國以外的地區，儘管該領域的競爭日益激烈，Repatha 仍然保持著該類別的領先地位，並在主要市場上繼續成長。 EVENITY 第三季銷售額年增 30%，達到近 4 億美元。

In the US, EVENITY continues to be the segment leader with 61% of the bone builder market. Strong US volume growth was supported by an increase in prescription volume from both established and new EVENITY prescribers with a 34% quarter-over-quarter increase in new provider accounts ordering EVENITY. In Japan, EVENITY continues to hold a leading position with 47% of the bone builder segment. Since launching in Japan in 2019, EVENITY has been prescribed to approximately 600,000 patients.

在美國，EVENITY 繼續佔據該細分市場的領導者地位，佔據骨骼增強劑市場的 61% 份額。美國銷售的強勁成長得益於現有和新的 EVENITY 處方者的處方量增加，訂購 EVENITY 的新提供者帳戶環比增長了 34%。在日本，EVENITY 繼續保持領先地位，在骨骼增強劑領域佔據 47% 的份額。自 2019 年在日本推出以來，EVENITY 已為約 60 萬名患者開出處方。

EVENITY sales are now annualizing at approximately $1.5 billion. We're encouraged by the growth momentum we are driving and have conviction in the potential for EVENITY to help the many more women globally who remain at risk of a fracture due to their post-menopausal osteoporosis.

EVENITY 目前的年銷售額約為 15 億美元。我們對所推動的成長勢頭感到鼓舞，並堅信 EVENITY 有潛力幫助全球更多因停經後骨質疏鬆症而面臨骨折風險的女性。

Prolia sales increased 6% year overyear to $1 billion for the third quarter, driven by 9% volume growth. In the US, we see broad prescribing base with more than 13,000 provider accounts using Prolia so far this year.

在銷售成長 9% 的推動下，Prolia 第三季銷售額年增 6%，達到 10 億美元。在美國，今年到目前為止，我們看到使用 Prolia 的處方基礎廣泛，有超過 13,000 個提供者帳戶。

In inflammation, TEZSPIRE continues its strong trajectory with $269 million in sales in the third quarter. Sales increased 67% year over year, supported by TEZSPIRE's uniquely differentiated profile and increased adoption by pulmonologists. We're encouraged by the growth of TEZSPIRE to date and its potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma.

在發炎領域，TEZSPIRE 繼續保持強勁勢頭，第三季銷售額達 2.69 億美元。得益於 TEZSPIRE 獨特的差異化形像以及肺科醫生越來越多的採用，銷售額年增 67%。我們對 TEZSPIRE 迄今為止的發展及其治療全球 250 萬嚴重不受控制的氣喘患者的潛力感到鼓舞。

Otezla sales decreased 1% year over year for the third quarter with 5% volume growth. This volume growth was offset by 7% lower net selling price. Otezla remains the only approved oral systemic therapy with a broad indication and is well positioned to help the more than 1.5 million systemic treatment-naive US patients with milder psoriasis who cannot be optimally addressed by a topical treatment.

Otezla 第三季銷售額年減 1%，但銷量成長 5%。銷量成長被淨售價下降 7% 所抵銷。 Otezla 仍然是唯一獲得批准的具有廣泛適應症的口服全身療法，並且能夠很好地幫助超過 150 萬未接受過全身治療的美國輕度牛皮癬患者，這些患者無法透過局部治療得到最佳治療。

Enbrel sales decreased 20% year over year for the third quarter, primarily driven by 13% unfavorable changes to estimated sales deductions and 12% lower net selling price. Volumes grew 4% in the quarter. Going forward, we expect continued declining net selling price, relatively stable volume, providing strong cash flow for our business.

Enbrel 第三季銷售額年減 20%，主要是因為預期銷售扣除額發生 13% 的不利變化以及淨售價下降 12%。本季銷量成長 4%。展望未來，我們預期淨售價將持續下降，銷售量相對穩定，為我們的業務提供強勁的現金流。

Sales of our biosimilar products increased 9% year over year in the third quarter. We have fully deployed our team in support of the recent US launch of PAVBLU, a biosimilar to EYLEA. Our teams moved quickly to engage retina specialists, and we're encouraged by the enthusiastic feedback from customers.

第三季我們的生物相似藥銷售額年增9%。我們已全面部署我們的團隊來支援最近在美國推出的 PAVBLU（一種 EYLEA 的生物相似藥）。我們的團隊迅速採取行動聘請視網膜專家，客戶的熱情回饋令我們深受鼓舞。

Our teams are also ready for the upcoming US launches of WEZLANA, a biosimilar to STELARA and BEKEMV, a biosimilar to Solaris, expected in the first and second quarters of 2025, respectively. Overall, our biosimilars portfolio continues to deliver attractive returns driven by our efficient business model.

我們的團隊也準備好迎接即將在美國推出的 WEZLANA（一種 STELARA 的生物相似藥）和 BEKEMV（一種 Solaris 的生物仿製藥），預計分別於 2025 年第一季和第二季推出。總體而言，在我們高效的商業模式的推動下，我們的生物相似藥產品組合繼續帶來有吸引力的回報。

In oncology, sales of our seven innovative products, BLINCYTO, LUMAKRAS, Vectibix, KYPROLIS, Nplate, XGEVA, and IMDELLTRA grew 17% year over year for the third quarter, driven by volume growth and higher net selling price. In total, these products contributed over $2 billion of sales in the third quarter.

在腫瘤學領域，受銷售成長和淨售價上漲的推動，我們的七種創新產品 BLINCYTO、LUMAKRAS、Vectibix、KYPROLIS、Nplate、XGEVA 和 IMDELLTRA 第三季度的銷售額年增 17%。這些產品第三季的銷售額總計超過 20 億美元。

BLINCYTO sales grew 49% year over year to $327 million for the third quarter. Growth was supported by the recent expansion of the BLINCYTO label, now approved by the US Food and Drug Administration for use in patients with Philadelphia chromosome-negative B-cell ALL in the consolidation phase regardless of measurable residual disease status.

BLINCYTO 第三季銷售額年增 49%，達到 3.27 億美元。最近 BLINCYTO 標籤的擴展支持了增長，該標籤現已獲得美國食品和藥物管理局批准，用於處於鞏固期的費城染色體陰性 B 細胞 ALL 患者，無論可測量的殘留疾病狀態如何。

Our US launch of IMDELLTRA is progressing well, generating $36 million of sales in the third quarter. There's strong clinical conviction in both academic and community settings, driven by IMDELLTRA's breakthrough efficacy. We have a strong sense of urgency to bring IMDELLTRA to patients living with this aggressive disease.

我們在美國推出的 IMDELLTRA 進展順利，第三季銷售額達 3,600 萬美元。在 IMDELLTRA 突破性功效的推動下，學術界和社區都擁有強烈的臨床信念。我們有強烈的緊迫感，將 IMDELLTRA 帶給患有這種侵襲性疾病的患者。

LUMAKRAS sales increased 88% year over year to $98 million for the third quarter. Vectibix sales increased 12% year over year to $282 million for the third quarter, now annualizing at over $1 billion. And KYPROLIS grew 8% year over year to $378 million in the quarter. Nplate sales increased 9% to $456 million for the third quarter. If we exclude government sales, Nplate sales grew 18% year over year for the third quarter, driven by 14% volume growth and higher net selling price.

LUMAKRAS 第三季銷售額年增 88%，達到 9,800 萬美元。 Vectibix 第三季銷售額年增 12%，達到 2.82 億美元，目前年化銷售額超過 10 億美元。 KYPROLIS 本季年增 8%，達到 3.78 億美元。第三季 Nplate 銷售額成長 9%，達到 4.56 億美元。如果我們排除政府銷售，在 14% 的銷量成長和更高的淨售價的推動下，第三季 Nplate 銷售額年增 18%。

We've made significant progress in this quarter, driving execution and accelerating performance of our most important growth brands.

我們在本季度取得了重大進展，推動了我們最重要的成長品牌的執行並加速了業績。

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

接下來，我會將其交給 Vikram，他將負責我們的罕見疾病組合。

Thank you, Murdo. I am pleased to provide an update on rare disease, which delivered product sales of $1.2 billion in Q3.

謝謝你，默多。我很高興提供有關罕見疾病的最新信息，該疾病在第三季度實現了 12 億美元的產品銷售額。

Beginning with TEPEZZA for the treatment of thyroid eye disease. Third-quarter sales were $488 million, reflecting growth of 8% year over year when compared to results from the legacy Horizon business. Recall, there are roughly 100,000 TED patients in the US and penetration is currently only in the single digits. We are excited about the growth opportunity presented by the roughly 80% of TED patients who have a lower clinical activity score, or CAS.

從 TEPEZZA 開始用於治療甲狀腺眼疾。第三季銷售額為 4.88 億美元，與傳統 Horizo​​n 業務相比年增 8%。回想一下，美國大約有 10 萬名 TED 患者，而目前的普及率僅為個位數。我們對約 80% 臨床活動評分 (CAS) 較低的 TED 患者所提供的成長機會感到興奮。

As we have discussed previously, to more effectively reach these patients, we have recently reorganized and expanded our field force into two separate and dedicated teams, one focused on comprehensive ophthalmologists and ocular specialists and the other focused on endocrinologists. This approach reflects an optimized footprint to continue to serve patients with high CAS disease while expanding our reach to those patients with low CAS disease who can benefit from TEPEZZA.

正如我們之前所討論的，為了更有效地接觸這些患者，我們最近將我們的現場隊伍重組並擴大為兩個獨立的專門團隊，一個專注於綜合眼科醫生和眼科專家，另一個專注於內分泌科醫生。這種方法反映了一種優化的足跡，可以繼續為患有高 CAS 疾病的患者提供服務，同時將我們的服務範圍擴大到那些可以從 TEPEZZA 中受益的低 CAS 疾病患者。

We made this change in the third quarter. And over the last few weeks, these teams have been actively focused on establishing new relationships with potential new prescribers. We expect this optimized focus to gain traction over the next few quarters as physicians become more experienced identifying the right patients for treatment and navigating the reimbursement process to enable access to TEPEZZA.

我們在第三季做出了這項改變。在過去的幾周里，這些團隊一直積極致力於與潛在的新處方醫生建立新的關係。我們預計，隨著醫生在確定合適的治療患者和指導報銷流程以獲取 TEPEZZA 方面變得更有經驗，這種優化的重點將在未來幾個季度獲得關注。

Following our 8% year-over-year growth this quarter, we remain confident in the long-term potential for TEPEZZA in the US as we expand our reach to patients with low CAS disease and continue to work closely with payers to expand access.

繼本季度同比增長 8% 後，我們對 TEPEZZA 在美國的長期潛力充滿信心，因為我們將覆蓋範圍擴大到低 CAS 疾病患者，並繼續與付款人密切合作以擴大使用範圍。

International expansion remains a key growth opportunity with regulatory filings completed or in progress across multiple regions. TEPEZZA's approval in Japan in September marked a key milestone ahead of its launch, which is 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.

國際擴張仍然是一個關鍵的成長機會，多個地區的監管備案已完成或正在進行中。 TEPEZZA 於9 月在日本獲得批准，標誌著其上市前的一個重要里程碑，預計將於2025 年初上市。來增加採用率和改善患者體驗。

KRYSTEXXA for patients with chronic refractory gout delivered $310 million in sales in Q3, representing 23% year-over-year growth driven by volume growth from strong commercial execution. KRYSTEXXA with immunomodulation has established a new standard of care for chronic refractory gout.

用於治療慢性難治性痛風患者的 KRYSTEXXA 在第三季度實現了 3.1 億美元的銷售額，同比增長 23%，這得益於強勁的商業執行帶來的銷量增長。 KRYSTEXXA 具有免疫調節功能，為慢性難治性痛風建立了新的護理標準。

UPLIZNA for patients with neuromyelitis optica spectrum disorder, or NMOSD, delivered $106 million in sales in Q3, representing 58% year-over-year growth. International expansion of UPLIZNA is also underway with launches in multiple markets, including Canada, which launched earlier this year. Additionally, we're excited by the growth potential of UPLIZNA driven by the striking data in both IgG4-related disease, which affects over 20,000 patients in the US and generalized myasthenia gravis or gMG, which affects nearly 80,000 to 100,000 patients in the US.

用於治療視神經脊髓炎譜系障礙 (NMOSD) 患者的 UPLIZNA 第三季銷售額為 1.06 億美元，較去年同期成長 58%。 UPLIZNA 的國際擴張也在進行中，在多個市場推出，包括今年稍早推出的加拿大。此外，我們對 UPLIZNA 的成長潛力感到興奮，這是由 IgG4 相關疾病（影響美國 20,000 多名患者）和全身重症肌無力（gMG）（影響美國近 80,000 至 100,000 名患者）的驚人數據推動的。

Sales of TAVNEOS were $80 million for the third quarter. Sales increased 116% year over year, driven by volume growth. In the US, more than 4,300 patients with ANCA-associated vasculitis have been treated with TAVNEOS. Over 2,600 healthcare professionals have now prescribed TAVNEOS, a roughly 53% increase in the prescriber base so far this year. As we reflect on the past year, it's clear how far we've come in the integration and how well we're progressing.

TAVNEOS 第三季銷售額為 8,000 萬美元。在銷量成長的推動下，銷售額較去年同期成長 116%。在美國，超過 4,300 名 ANCA 相關血管炎患者接受了 TAVNEOS 治療。目前已有超過 2,600 名醫療保健專業人員開出了 TAVNEOS 處方，今年迄今為止，處方者數量增加了約 53%。當我們回顧過去的一年時，我們很清楚我們在整合方面已經取得了多大的進展以及進展如何。

I want to take this opportunity to express my sincere gratitude to all the team members that are working tirelessly to serve the needs of patients suffering from rare diseases. Looking ahead, we're excited about the opportunities and confident in what we'll achieve in our rare disease business and beyond.

我想藉此機會向所有為罕見疾病患者的需求而不懈努力的團隊成員表示誠摯的謝意。展望未來，我們對機會感到興奮，並對我們在罕見疾病業務及其他領域的成就充滿信心。

Now I'll hand it over to Jay for our R&D update.

現在我將把它交給 Jay 以獲取我們的研發更新。

Thank you, Vikram, and good afternoon, everyone. In the third quarter, we made significant progress advancing our broad clinical pipeline, which includes a number of potentially first-in-class or best-in-class therapies. Since our last update, we have initiated a Phase 2 study of MariTide in type 2 diabetes and delivered positive potentially practice-changing Phase 3 data with UPLIZNA in generalized myasthenia gravis.

謝謝維克拉姆，大家下午好。第三季度，我們在推動廣泛的臨床管道方面取得了重大進展，其中包括許多潛在的一流或一流療法。自上次更新以來，我們啟動了 MariTide 治療 2 型糖尿病的 2 期研究，並提供了 UPLIZNA 治療全身性重症肌無力的積極的、可能改變實踐的 3 期數據。

Additionally, the FDA granted Breakthrough Therapy designation for UPLIZNA in IgG4-related diseases underscoring the important potential impact of this medicine. We also showcased promising data from several oncology programs at major medical conferences, including IMDELLTRA, xaluritamig and AMG 193, while reporting positive results from the first of eight Phase 3 studies evaluating rocatinlimab in atopic dermatitis.

此外，FDA 還授予 UPLIZNA 用於 IgG4 相關疾病的突破性療法稱號，強調了該藥物的重要潛在影響。我們也在主要醫學會議上展示了來自多個腫瘤學計畫的有希望的數據，包括IMDELLTRA、xaluritamig 和AMG 193，同時報告了評估rocatinlimab 在異位性皮膚炎中的八項3 期研究中的第一項的正面結果。

Let's begin with general medicine. As previously mentioned, based upon the interim analysis of the ongoing Phase 2 study of MariTide in chronic weight management, we are seeing a differentiated profile and are confident MariTide will address important unmet medical needs in obesity, obesity-related conditions in type 2 diabetes.

讓我們從普通醫學開始。如前所述，根據正在進行的MariTide 在慢性體重管理方面的2 期研究的中期分析，我們看到了差異化的概況，並相信MariTide 將解決肥胖和2 型糖尿病肥胖相關疾病中重要的未滿足的醫療需求。

We remain on track and look forward to top-line 52-week data from the 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 type 2 diabetes.

我們仍按計劃前進，並期待在 2024 年底獲得 MariTide 第 2 期研究的 52 週頂線數據。

This quarter, we initiated a dedicated Phase 2 trial investigating MariTide in patients with type 2 diabetes, living with and without obesity. MariTide has the potential to be the first therapy in this setting with monthly or even less frequent dosing. Beyond MariTide, our Phase 1 trial of AMG 513 is actively enrolling patients. We also continue to advance our preclinical obesity programs, which include both oral and injectable approaches comprising both incretin and non-incretin mechanisms.

本季度，我們啟動了一項專門的 2 期試驗，研究 MariTide 在患有或不患有肥胖症的 2 型糖尿病患者中的作用。 MariTide 有潛力成為這種情況下的第一種療法，每月甚至更低的給藥頻率。除了 MariTide 之外，我們的 AMG 513 一期試驗正在積極招募患者。我們也繼續推進我們的臨床前肥胖項目，其中包括口服和注射方法，包括腸促胰島素和非腸促胰島素機制。

Also in general medicine is olpasiran, our potentially best-in-class LP(a) targeting small interfering RNA medicine. The fully enrolled Phase 3 cardiovascular outcomes trial of olpasiran continues to progress. In oncology, IMDELLTRA, a first-in-class bispecific T-cell engager or BiTE molecule, targeting DLL3 for small cell lung cancer is rapidly advancing into earlier lines of therapy with three Phase 3 studies underway in both extensive stage and limited stage disease.

在普通醫學領域，還有 olpasiran，我們潛在的同類最佳 LP(a)，針對小幹擾 RNA 藥物。 olpasiran 完全入組的 3 期心血管結局試驗仍在持續取得進展。在腫瘤學領域，IMDELLTRA 是一種首創的雙特異性T 細胞接合劑或BiTE 分子，以DLL3 為標靶治療小細胞肺癌，目前正在迅速進入早期治療系列，目前正在進行廣泛期和局限性疾病的三項3 期研究。

To further enhance the patient experience, we are evaluating reduced monitoring protocols as part of the Phase 3 program, and we have initiated a Phase 1b study evaluating subcutaneous tarlatamab in patients with second line or later extensive-stage small cell lung cancer. In September, we presented impressive follow-up data from our DeLLphi 301 Phase 2 study of IMDELLTRA in patients with extensive stage small cell lung cancer, demonstrating sustained anticancer activity and a manageable safety profile.

為了進一步增強患者體驗，我們正在評估減少監測方案，作為 3 期計劃的一部分，並且我們已經啟動了一項 1b 期研究，評估二線或後期廣泛期小細胞肺癌患者皮下注射 tarlatamab。 9 月，我們公佈了 IMDELLTRA 在廣泛期小細胞肺癌患者中的 DeLLphi 301 2 期研究的令人印象深刻的後續數據，證明了持續的抗癌活性和可控的安全性。

We also presented data from DeLLphi 303, the Phase 1b study of IMDELLTRA combined with a PD-L1 inhibitor as maintenance therapy following four cycles of chemotherapy and first-line extensive-stage small cell lung cancer. This design is similar to our ongoing Phase 3 study, DeLLphi 305, which test the efficacy of IMDELLTRA and PD-L1 inhibition versus PD-L1 inhibition alone, in first-line extensive-stage small cell lung cancer, following platinum-based chemotherapy.

我們也提供了 DeLLphi 303 的數據，這是 IMDELLTRA 聯合 PD-L1 抑制劑作為一線廣泛期小細胞肺癌化療四個週期後維持治療的 1b 期研究。該設計類似於我們正在進行的 3 期研究 DeLLphi 305，該研究測試了 IMDELLTRA 和 PD-L1 抑制與單獨 PD-L1 抑制在一線廣泛期小細胞肺癌中鉑類化療後的療效。

With a median follow-up of 10 months, IMDELLTRA has demonstrated a manageable safety profile, median duration of disease control of 9.3 months, median progression-free survival of 5.6 months, and a 9-month estimated overall survival of 89%.

中位追蹤時間為10 個月，IMDELLTRA 表現出可控的安全性、中位疾病控制持續時間為9.3 個月、中位無惡化存活期為5.6 個月、9 個月估計總存活率為89% 。

Moving to our first-in-class STEAP1 CD3 bispecific molecule, xaluritamig. We are pleased to announce that following consultation with regulatory authorities, we will initiate a Phase 3 study in post-taxane metastatic castrate-resistant prostate cancer, or mCRPC, this quarter. The promise of xaluritamig was recently evidenced by data presented in September from a Phase 1 dose exploration cohort evaluating monotherapy in patients with mCRPC.

轉向我們一流的 STEAP1 CD3 雙特異性分子 xaluritamig。我們很高興地宣布，在與監管機構協商後，我們將於本季啟動紫杉烷後轉移性去勢抵抗性前列腺癌（mCRPC）的 3 期研究。 Xaluritamig 的前景最近得到了 9 月公佈的 1 期劑量探索隊列數據的證明，該隊列評估了 mCRPC 患者的單一療法。

With a median follow-up of 27.9 months, the median overall survival was 17.7 months across all cohorts, a potential improvement upon the historical median survival of 12 to 15 months in this patient population. Additional data from a Phase 1 randomized dose expansion and optimization cohort has identified the recommended dose and schedule for Phase 3 clinical investigation. Additionally, we are studying xaluritamig in earlier lines of therapy in combination and in earlier stages of prostate cancer.

中位追蹤時間為 27.9 個月，所有隊列的中位總存活期為 17.7 個月，較該患者群體的歷史中位存活期 12 至 15 個月有潛在改善。來自一期隨機劑量擴展和優化隊列的額外數據已經確定了三期臨床研究的建議劑量和時間表。此外，我們正在研究 xaluritamig 在早期聯合治療和前列腺癌早期階段的應用。

Our Phase 1 study of xaluritamig in combination with enzalutamide and abiraterone is ongoing. Recently, we have initiated two additional Phase 1b studies investigating xaluritamig in the upfront management of more localized disease. The first study evaluates neoadjuvant xaluritamig therapy that is prior to radical prostatectomy in patients with newly diagnosed, localized, intermediate or high-risk prostate cancer.

我們將 xaluritamig 與 enzalutamide 和 abiraterone 聯合使用的 1 期研究正在進行中。最近，我們啟動了另外兩項 1b 期研究，調查 xaluritamig 在更局部疾病的前期管理中的作用。第一項研究評估了新診斷的局限性、中度或高風險前列腺癌患者在根治性前列腺切除術之前的新輔助xaluritamig治療。

The second study evaluates xaluritamig in high-risk nonmetastatic hormone-sensitive prostate cancer after definitive therapy. We are particularly excited about the potential of xaluritamig, now our third bispecific T-cell engager entering late-stage clinical development. Beyond our T-cell engagers, we have completed enrollment of FORTITUDE-102, a Phase 3 study of bemarituzumab, our first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody combined with chemotherapy and nivolumab in first-line gastric cancer.

第二項研究評估了 Xaluritamig 在確定性治療後對高風險非轉移性荷爾蒙敏感前列腺癌的療效。我們對 xaluritamig 的潛力感到特別興奮，它是我們第三種雙特異性 T 細胞接合劑，現已進入後期臨床開發。除了我們的T 細胞接合劑之外，我們還完成了FORTITUDE-102 的入組，這是一項bemarituzumab 的3 期研究，bemarituzumab 是我們一流的成纖維細胞生長因子受體IIb 定向單株抗體，聯合化療和納武單抗治療第一線胃癌。

In the coming months, we expect to read out the results of FORTITUDE-101, a Phase 3 study of bemarituzumab combined with mFOLFOX6 chemotherapy versus chemotherapy alone in first-line gastric cancer. This study was designed based on the successful Phase 2 FIGHT study, which reported numerically longer progression-free survival and overall survival.

在接下來的幾個月中，我們預計將發表 FORTITUDE-101 的結果，這是一項 bemarituzumab 聯合 mFOLFOX6 化療與單獨化療治療一線胃癌的 3 期研究。這項研究是基於成功的 2 期 FIGHT 研究而設計的，該研究報告了更長的無惡化存活期和總生存期。

Lastly, we are also rapidly advancing AMG 193, our oral PRMT5 inhibitor developed for MTAP-null solid tumors. We recently initiated a Phase 2 study of AMG 193 in patients with MTAP-null previously treated advanced non-small cell lung cancer. This study will help to address regulatory agency requirements for dose optimization and selection.

最後，我們也正在快速推進 AMG 193，這是我們為 MTAP 無效實體腫瘤開發的口服 PRMT5 抑制劑。我們最近在 MTAP 缺失的先前接受過治療的晚期非小細胞肺癌患者中啟動了 AMG 193 的 2 期研究。這項研究將有助於滿足監管機構對劑量優化和選擇的要求。

In September, we presented encouraging data from a Phase 1 dose escalation and initial dose expansion study, demonstrating promising monotherapy activity and an acceptable safety profile.

9 月份，我們公佈了來自 1 期劑量遞增和初始劑量擴展研究的令人鼓舞的數據，證明了有希望的單一療法活性和可接受的安全性。

Turning to inflammation. Based upon encouraging Phase 2 data from TEZSPIRE in patients with COPD, we are planning to initiate Phase 3 studies in collaboration with AstraZeneca. These trials will target patients with moderate to very severe COPD with blood eosinophil counts greater than or equal to 150 cells per microliter. We expect to begin enrollment in the first half of 2025.

轉向炎症。基於 TEZSPIRE 在 COPD 患者中令人鼓舞的 2 期數據，我們計劃與阿斯特捷利康合作啟動 3 期研究。這些試驗將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慢性阻塞性肺病患者。我們預計將於 2025 年上半年開始招生。

TEZSPIRE is also being investigated in separate Phase 3 studies of patients with eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top line data are expected later this year. In September, we announced positive results from the Phase 3 Horizon study of rocatinlimab in atopic dermatitis. The study met its co-primary endpoints and all key secondary endpoints.

TEZSPIRE 也正在針對嗜酸粒細胞性食道炎和伴有鼻息肉的慢性鼻竇炎患者進行單獨的 3 期研究，預計將於今年稍後獲得頂線數據。 9 月，我們宣布了 rocatinlimab 治療異位性皮膚炎的 3 期 Horizo​​n 研究的正面結果。該研究達到了其共同主要終點和所有關鍵次要終點。

We anticipate additional data readouts from the ROCKET program will deepen our understanding of rocatinlimab profile. Beyond atopic dermatitis, we continue to explore rocatinlimab in moderate to severe asthma and prurigo nodularis. To expand the impact of our CD19 directed therapeutics for even more patients suffering from serious inflammatory diseases, we have initiated Phase 2 studies of blinatumomab our CD19 targeting BiTE molecule approved as BLINCYTO and inebilizumab, our CD19 targeting monoclonal antibody approved as UPLIZNA.

我們預計 ROCKET 計畫的額外數據讀數將加深我們對 rocatinlimab 概況的理解。除了異位性皮膚炎之外，我們也繼續探索 rocatinlimab 對中度至重度氣喘和結節性癢疹的治療。為了擴大我們的CD19 定向療法對更多患有嚴重發炎性疾病的患者的影響，我們已經啟動了blinatumomab（我們的CD19 靶向BiTE 分子，批准為BLINCYTO）和inebilizumab（我們的CD19 靶向單株抗體核准為UPLIZNA）的2 期研究。

These studies build on mounting evidence of therapeutic benefit for B-cell depletion in autoimmune diseases from small investigator-sponsored trials of blinatumomab in systemic sclerosis and refractory rheumatoid arthritis. Our initial focus will be on systemic lupus erythematosus with nephritis with plans to expand into additional indications.

這些研究建立在越來越多的證據基礎上，這些證據來自小型研究者資助的blinatumomab 治療系統性硬化症和難治性類風濕性關節炎的試驗，證明B 細胞耗竭對自體免疫疾病有治療益處。我們最初的重點將是系統性紅斑狼瘡伴隨腎炎，並計劃擴展到其他適應症。

Shifting to rare disease. We recently presented potentially practice-changing results from the Phase 3 MINT study, the largest placebo-controlled trial for a biologic therapy in generalized myothenia gravis. MINT evaluated UPLIZNA in both acetylcholine receptor autoantibody positive ACHR positive and muscle-specific kinase autoantibody positive or MuSK-positive populations.

轉向罕見疾病。我們最近提出了 3 期 MINT 研究的可能改變實踐的結果，這是針對全身性重症肌無力的生物療法最大的安慰劑對照試驗。 MINT 在乙醯膽鹼受體自體抗體陽性 ACHR 陽性和肌肉特異性激酶自體抗體陽性或 MuSK 陽性人群中評估了 UPLIZNA。

At the reported 26-week timepoint, UPLIZNA demonstrated clinically meaningful and statistically significant improvements in the myasthenia gravis activities of daily living score after just two doses compared to placebo. This efficacy was observed in the combined ACHR and MuSK-positive populations as well as in each population separately. UPLIZNA also achieved statistically significant improvements in the quantitative myasthenia gravis score, compared to placebo at week 26 in the combined populations.

在報告的 26 週時間點，與安慰劑相比，UPLIZNA 僅服用兩次劑量後，重症肌無力的日常生活評分就有了臨床意義和統計學上的顯著改善。在 ACHR 和 MuSK 陽性聯合人群以及單獨的每個人群中都觀察到了這種功效。在第 26 週時，與安慰劑相比，UPLIZNA 在合併族群中的重症肌無力定量評分方面也取得了統計學上的顯著改善。

Importantly, in the MINT study, patients taking corticosteroids were tapered down starting at week four to a 5-milligram-per-day dose by week 24. MINT is the first and only Phase 3 placebo-controlled myasthenia gravis trial for a biologic that tapered corticosteroid use. As such, the efficacy observed with UPLIZNA in patients with generalized myasthenia gravis offers a chance for meaningful benefit without the burden and toxicity of chronic steroid use.

重要的是，在MINT 研究中，服用皮質類固醇的患者從第4 週開始逐漸減少到第24 週每天5 毫克的劑量。重症肌無力試驗。因此，在全身性重症肌無力患者中觀察到 UPLIZNA 的療效提供了獲得有意義的益處的機會，而沒有長期使用類固醇的負擔和毒性。

We look forward to 52-week data for the ACHR positive cohort and results from both ACHR positive and MuSK-positive patient populations. In the open-label period of the MINT study, where UPLIZNA has the potential to demonstrate durable efficacy.

我們期待 ACHR 陽性隊列的 52 週數據以及 ACHR 陽性和 MuSK 陽性患者群體的結果。在 MINT 研究的開放標籤期，UPLIZNA 有潛力展示持久療效。

Moving beyond generalized myasthenia gravis in August, the FDA granted UPLIZNA Breakthrough Therapy designation for the treatment of immunoglobulin G4-related diseases, or IgG4-related disease based upon data from the Phase 3 MITIGATE study. This data will be presented at the American College of Rheumatology Conference in November. We are extremely encouraged by the potential of UPLIZNA in both myasthenia gravis and IgG4-related disease and are actively working to file these data with regulatory authorities.

8 月份，FDA 超越了全身性重症肌無力，根據 3 期 MITIGATE 研究的數據，授予 UPLIZNA 突破性療法稱號，用於治療免疫球蛋白 G4 相關疾病或 IgG4 相關疾病。數據將於 11 月在美國風濕病學會會議上公佈。我們對 UPLIZNA 在重症肌無力和 IgG4 相關疾病方面的潛力感到非常鼓舞，並正在積極向監管機構提交這些數據。

In closing, I want to thank my Amgen colleagues for their unwavering commitment to patients facing grievous illnesses for the focus and for the collaboration during this productive year.

最後，我要感謝我的安進同事們在這富有成果的一年裡對患有嚴重疾病的患者的堅定承諾和合作。

I'll now turn it over to Peter for the financial update.

我現在將把它交給彼得以獲取最新的財務資訊。

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

謝謝你，傑伊。我們對第三季的強勁表現感到滿意，並正在實現 2024 年全年目標和長期目標。我們在四個治療領域中的每一個領域都擁有強勁的長期成長前景，包括我們的創新產品線和市場產品，為全球患有嚴重疾病的患者提供服務。

We will continue to allocate capital to innovation first and with our strong cash flows, also intend to fund our other capital allocation priorities. Starting with our third-quarter results as shown on slide 28 of the slide deck, we delivered $8.5 billion in total revenues, a 23% year-over-year increase.

我們將繼續首先將資本分配給創新，並利用我們強勁的現金流，也打算為我們的其他資本分配優先事項提供資金。從投影片第 28 張投影片所示的第三季業績開始，我們實現了 85 億美元的總收入，比去年同期成長 23%。

Excluding the addition of Horizon, product sales increased 8% year over year, driven by 12% volume growth. In the US, our sales in the quarter were impacted by $173 million and unfavorable changes to estimated sales deductions. In the third quarter, we delivered a non-GAAP operating margin of 49.6% as a percentage of product sales with total non-GAAP operating expenses increasing 27% year over year, largely driven by the addition of Horizon.

不包括 Horizo​​n 的加入，在銷售成長 12% 的推動下，產品銷售額年增 8%。在美國，我們本季的銷售額受到 1.73 億美元的影響以及預計銷售扣除額的不利變化。第三季度，我們的非 GAAP 營業利潤佔產品銷售額的百分比為 49.6%，非 GAAP 營業費用總額年增 27%，這主要是由於 Horizo​​n 的加入。

Non-GAAP R&D spending in the third quarter increased 35% year over year to $1.4 billion as we invested in the rapidly advancing late-stage pipeline including MariTide, bemarituzumab and olpasiran as well as Horizon acquired programs. Non-GAAP SG&A expenses increased 21% year over year, primarily driven by the addition of Horizon, excluding the addition of Horizon, non-GAAP SG&A expenses were relatively flat year over year.

第三季的非 GAAP 研發支出年增 35%，達到 14 億美元，因為我們投資了快速推進的後期研發管線，包括 MariTide、bemarituzumab 和 olpasiran 以及 Horizo​​n 收購的項目。非 GAAP SG&A 費用年增 21%，主要是由於 Horizo​​n 的增加所致，排除 Horizo​​​​n 的增加，非 GAAP SG&A 費用同比相對持平。

The Horizon integration is progressing well, and we expect to reach $500 million in pretax cost synergies by year three post-acquisition with more than 50% to be realized by the end of this year. The acquisition is accretive to non-GAAP EPS year to date, and we expect it to be for the full year as well.

Horizo​​n 整合進展順利，我們預計到收購後第三年稅前成本協同效應將達到 5 億美元，其中 50% 以上將在今年年底實現。此次收購增加了今年迄今的非公認會計準則每股收益，我們預計全年也將如此。

Our non-GAAP OI&E resulted in a $554 million expense, up $329 million year over year, almost entirely due to increased interest expense from the Horizon acquisition. We continue to strengthen our balance sheet with $2.5 billion of debt retired in the third quarter and expect to return to our pre-Horizon acquisition capital structure by the end of 2025.

我們的非 GAAP OI&E 支出為 5.54 億美元，年增 3.29 億美元，幾乎完全是由於 Horizo​​n 收購帶來的利息支出增加。我們在第三季償還了 25 億美元的債務，繼續強化我們的資產負債表，並預計到 2025 年底恢復到 Horizo​​​​n 收購前的資本結構。

Our non-GAAP tax rate decreased 2.7 percentage points year over year to 13.4%, primarily due to the change in earnings mix from the inclusion of Horizon. In the third quarter of 2024, the company generated $3.3 billion of free cash flow, an increase of $2.5 billion from the previous year. Our strong cash flows enable investing in our business for long-term growth, including advancing our exciting pipeline opportunities and expanding capacity in our state-of-the-art manufacturing processes and facilities.

我們的非 GAAP 稅率年減 2.7 個百分點至 13.4%，這主要是由於納入 Horizo​​n 後收益組合發生了變化。 2024年第三季度，該公司產生了33億美元的自由現金流，比前一年增加了25億美元。我們強勁的現金流使我們能夠投資於我們的業務以實現長期成長，包括推進我們令人興奮的管道機會以及擴大我們最先進的製造流程和設施的產能。

Our past investments enable us to serve a significant number of patients today. For example, with over 43 million units expected for Repatha and Prolia alone in 2024, ongoing and future investments will support MariTide and other products across the portfolio. In addition, we returned capital to shareholders as we paid competitive dividend of $2.25 per share in the second quarter. This represented a 6% increase compared to 2023.

我們過去的投資使我們今天能夠為大量患者提供服務。例如，預計到 2024 年，僅 Repatha 和 Prolia 的銷售將超過 4,300 萬台，持續和未來的投資將支援 MariTide 和整個產品組合中的其他產品。此外，我們也向股東返還了資本，第二季支付了每股 2.25 美元的有競爭力的股息。與 2023 年相比增加了 6%。

Let's turn to the outlook for the business for 2024 on slide 30. We expect our 2024 total revenues in the range of $33.0 billion to $33.8 billion and non-GAAP EPS between $19.20 to $20. We do expect Q4 non-GAAP EPS to be lower than Q3 non-GAAP EPS because of planned investment increases in our business, including key assets in our innovative pipeline beginning with MariTide and olpasiran and other strategic business investments. This sequential pattern is consistent with historical trends.

讓我們轉向幻燈片 30 上的 2024 年業務前景。我們確實預計第四季度非 GAAP 每股收益將低於第三季非 GAAP 每股收益，因為我們計劃增加業務投資，包括從 MariTide 和 olpasiran 開始的創新管道中的關鍵資產以及其他戰略業務投資。這種連續模式與歷史趨勢是一致的。

Let me mention a few consideration as you model the remainder of 2024. We now project full-year new asset sales at approximately $400 million and other revenue at approximately $1.4 billion. We expect TEPEZZA sales in Q4 to be flat to slightly down versus the third quarter, resulting in full-year sales being up roughly 5% year over year as compared to the full year of TEPEZZA sales in 2023.

讓我在您對 2024 年剩餘時間進行建模時提及一些考慮因素。我們預計 TEPEZZA 第四季銷售額將與第三季度持平或略有下降，從而導致全年銷售額較 2023 年 TEPEZZA 全年銷售額同比增長約 5%。

Consistent with prior years, we expect Q4 non-GAAP operating expenses to be the highest of the year and expect approximately 28% of our full-year operating expenses to be in the fourth quarter. This includes additional investments to drive momentum into 2025, for example, in key brands like Repatha and EVENITY.

與往年一致，我們預計第四季非 GAAP 營運費用將是今年最高的，並預計第四季將佔全年營運費用的約 28%。這包括額外投資以推動 2025 年的發展勢頭，例如對 Repatha 和 EVENITY 等關鍵品牌的投資。

For the full year, our total non-GAAP operating expenses are expected to grow approximately 25% year over year, including from the addition of Horizon. We still expect full-year non-GAAP R&D growth of more than 25% year over year. We now expect OI&E to be approximately $2.4 billion to $2.5 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition.

全年，我們的非 GAAP 營運支出總額預計將年增約 25%，其中包括 Horizo​​n 的增加。我們仍然預計全年非 GAAP 研發年增率將超過 25%。我們現在預計 OI&E 約為 24 億至 25 億美元，其中包括與收購 Horizo​​​​n 籌集的 280 億美元債務相關的利息支出。

We now expect the non-GAAP tax rate to be in the 14% to 15% range, including the full-year benefits associated with the inclusion of the Horizon business and favorable items in the quarter identified in the return to provision process. Finally, our capital expenditure guidance remains at $1.3 billion for 2024.

我們現在預計非公認會計準則稅率將在 14% 至 15% 範圍內，包括與納入 Horizo​​​​n 業務相關的全年收益以及在撥備回報流程中確定的季度優惠項目。最後，我們的 2024 年資本支出指引仍為 13 億美元。

Our long-term growth outlook remains strong and I'm grateful to our colleagues worldwide for their dedication to serving patients. This concludes our financial update.

我們的長期成長前景依然強勁，我感謝世界各地的同事為患者服務的奉獻精神。我們的財務更新到此結束。

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

我現在將把它交還給鮑勃以進行問答環節。

(Operator Instructions) Salveen Richter, Goldman Sachs.

（操作員指令）Salveen Richter，高盛。

The Phase 2 MariTide data clearly remains the key update into year-end. Can you help us understand what you will share with regard to this update in terms of actual data and also the Phase 3 developmental plan and timelines and when we might get an update from the other obesity programs?

MariTide 第二階段數據顯然仍然是年底的關鍵更新。您能否幫助我們了解您將就本次更新分享的實際數據、第三階段開發計劃和時間表以及我們何時可以從其他肥胖計劃獲得更新？

Okay. It sounded like a few questions there, Salveen. As we said, we're continuing to be very excited about the prospects for MariTide, and we added the disclosure on this call that we have begun the Phase 2 study in type 2 diabetes. The conduct of the trial is continuing to progress well, and we're expecting to have the data here by the end of the year. And when we have those data, we'll obviously look forward to being able to share that with our investors.

好的。薩爾文，這聽起來像是幾個問題。正如我們所說，我們仍然對 MariTide 的前景感到非常興奮，並且我們在這次電話會議上補充說，我們已經開始 2 型糖尿病的 2 期研究。試驗的進行持續進展順利，我們預計將在今年年底前獲得數據。當我們獲得這些數據時，我們顯然會期待能夠與我們的投資者分享這些數據。

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

茱麗安.請讓我們進入下一個問題。

Olivia Brayer, Cantor Fitzgerald.

奧利維亞·布雷耶，康托·菲茨杰拉德。

You are getting a lot closer to kicking off a Phase 3 MariTide program. So how do you think about the level of spend that will go into that kind of undertaking? I mean I assume we're looking at billions as it relates to investments just around R&D, but also manufacturing. But yes, hoping you guys can put some numbers around it or at least better characterize how you're thinking about things from here. Also hoping you can clarify whether or not you have seen those Phase 2 data in-house?

您距離啟動第三階段 MariTide 計畫已經越來越近了。那麼您如何看待此類項目的支出水準？我的意思是，我假設我們正在考慮數十億美元，因為它不僅涉及研發投資，還涉及製造投資。但是，是的，希望你們能夠提供一些數字，或者至少更好地描述你們是如何思考這裡的事情的。也希望您能澄清一下您是否在內部看到這些第二階段的數據？

So with respect to the Phase 3 trial, we would reiterate that we are expecting to pursue a broad Phase 3 trial in obesity-related conditions and type 2 diabetes. It will be, we would expect a large global trial, fully exploring the molecule.

因此，關於第 3 期試驗，我們重申，我們期望針對肥胖相關疾病和第 2 型糖尿病進行廣泛的 3 期試驗。我們預計將進行大規模的全球試驗，以充分探索該分子。

And Jay, I'd invite you to add any color you'd like about the Phase 3 program. But obviously, our investment will reflect our view that this is a differentiated molecule, and we look forward to having the full characterization of its safety and efficacy profile.

Jay，我邀請您為第三階段計劃添加任何您想要的色彩。但顯然，我們的投資將反映我們的觀點，即這是一種差異化分子，我們期待對其安全性和有效性進行全面表徵。

Yeah. Thanks, Bob. We're fully on track actively planning and expect to initiate a broad Phase 3 program. This will include obesity, obesity-related conditions and type 2 diabetes, as you've heard already, we're progressing the Phase 2 study to characterize dose response, tolerability efficacy in patients. Importantly, without obesity but having type 2 diabetes. So we're fully on track, actively planning the broad program.

是的。謝謝，鮑伯。我們已完全步入正軌，積極規劃並期望啟動廣泛的第三階段計劃。這將包括肥胖、肥胖相關疾病和 2 型糖尿病，正如您已經聽說的，我們正在推進 2 期研究，以表徵患者的劑量反應和耐受性功效。重要的是，沒有肥胖但患有第 2 型糖尿病。因此，我們完全走上正軌，積極規劃廣泛的計劃。

And we'll -- as part of our normal guidance process in the coming year, I'm sure we'll give an updated perspective then that reflects our plans for the Phase 3 trial. And then we'll also add any perspective that may be helpful on the capital expenditure front.

作為來年正常指導流程的一部分，我相信我們將提供更新的觀點，以反映我們的第三階段試驗計劃。然後我們還將添加對資本支出方面可能有幫助的任何觀點。

I think what I just would remind you is that this molecule is designed on our existing antibody platform. It fits very well with our network as currently configured. And so again, we'll have more to say about that through time as necessary.

我想我只是想提醒您的是，該分子是在我們現有的抗體平台上設計的。它非常適合我們目前配置的網路。再說一次，我們將根據需要對此進行更多討論。

Maybe to suggest, Bob -- Olivia, it's Peter here. I would just remind you of Amgen's long history of being a leader in the science and manufacturing and process development that creates opportunities in terms of how we might view yield going forward. So while it might not just be bricks, mortar and steel, yield is really important, and we've got a really strong history in that.

也許是為了建議，鮑伯──奧莉維亞，我是彼得。我只想提醒您，安進作為科學、製造和工藝開發領域的領導者的悠久歷史，為我們如何看待未來的產量創造了機會。因此，雖然它可能不僅僅是磚塊、砂漿和鋼材，但產量確實很重要，而且我們在這方面擁有非常悠久的歷史。

And we did raise the CapEx guide this year, as you know, to about $1.3 billion. We're very thoughtful about that. And you also heard me mention that research and development spend up 35% quarter over quarter to the prior year. We expect it to be up over 25% for the year. So we certainly are investing where we always say we will in innovation and MariTide is right at the front of that, and we look forward to investing to be a key player in this global public health crisis.

如您所知，我們今年確實將資本支出指南提高至約 13 億美元。我們對此深思熟慮。您也聽到我提到研發支出比上年季度環比增長了 35%。我們預計今年漲幅將超過 25%。因此，我們當然會在我們一直所說的創新領域進行投資，而 MariTide 正是這方面的先鋒，我們期待著透過投資成為這場全球公共衛生危機的關鍵參與者。

Julliane, let's take the next question, please.

朱莉安，請讓我們回答下一個問題。

Michael Yee, Jefferies.

麥可葉，杰弗里斯。

Maybe for Jay, it sounds like you guys are quite confident about MariTide, and yet you are also building a greater portfolio I think you announced 513. And yet you also don't have an oral, I don't believe so. Can you just comment about your philosophy or thinking about the totality of the portfolio given 133 is so far in the Phase 3, but the other things are so early, and whether you believe you have the portfolio today to be competitive with everybody else who have so many things at late stage?

也許對 Jay 來說，聽起來你們對 MariTide 很有信心，但你們也在建立一個更大的投資組合，我認為你們宣布了 513。您能否評論一下您的理念或考慮投資組合的整體情況，因為到目前為止133 還處於第三階段，但其他事情還處於早期階段，以及您是否相信您今天擁有的投資組合可以與其他擁有該投資組合的人競爭後期這麼多事情？

Thanks, Mike. I really appreciate the question. With MariTide, we're really pleased with the execution of the study await data later this year, fully focused as I shared on setting up the broad Phase 3 program. The development of additional medicines for obesity and obesity-related conditions is a source of really active investigation here, preclinically and clinically now with 513 as you nicely mentioned. We've not as yet disclosed the mechanism of action of 513, which is a very interesting program.

謝謝，麥克。我真的很感激這個問題。對於 MariTide，我們對今年稍後等待數據的研究的執行感到非常滿意，正如我分享的那樣，我們完全專注於建立廣泛的第三階段計劃。其他針對肥胖和肥胖相關疾病的藥物的開發是這裡真正積極研究的一個來源，現在是臨床前和臨床 513，正如您所提到的。我們還沒有透露513的作用機制，這是一個非常有趣的項目。

And as you note, and this is on clinicaltrials.gov, the SAD/MAD ascending dose study has been announced is enrolling and feature subcutaneous or intravenous administration. To reach smaller segments, other segments within the obesity landscape to serve all the patients with obesity and it's related conditions.

如您所注意到的，這是在 ClinicalTrials.gov 上，SAD/MAD 劑量遞增研究已宣布正在招募，並以皮下或靜脈注射為特色。為了到達較小的細分市場，肥胖領域的其他細分市場為所有肥胖症及其相關疾病的患者提供服務。

We, like many others, are interested in both injectable as well as oral non-injectable medicines. We're very interested in incretin pathway as well as non incretin pathway mechanisms of action, and our portfolio reflects each of these.

和許多其他人一樣，我們對注射藥物和口服非注射藥物都感興趣。我們對腸促胰島素途徑以及非腸促胰島素途徑的作用機制非常感興趣，我們的產品組合反映了其中的每一個。

Julliane next question, please.

朱莉安，請下一個問題。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

Just anchoring on some of the conversations that you shared around the Horizon products and specifically TEPEZZA. Can you please provide some more context on the path to growth and when you expect to see the impact of the sales team there, particularly in the context of the final comments that we shared in terms of expectations for Q4 relative to Q3?

只是錨定您圍繞 Horizo​​​​n 產品（特別是 TEPEZZA）分享的一些對話。您能否提供更多關於成長路徑的背景信息，以及您期望看到銷售團隊的影響的時間，特別是在我們就第四季度相對於第三季度的預期所分享的最終評論的背景下？

Yeah. Let's take it in a couple of pieces. First, as you heard us say, the quarter grew 8%. Vikram, why don't you just remind our investors of the plans for expanding Salesforce and then also perhaps speak to Japan or international more general?

是的。讓我們把它分成幾個部分。首先，正如我們所說，該季度增長了 8%。 Vikram，為什麼不提醒我們的投資者擴大 Salesforce 的計劃，然後也許還可以與日本或更廣泛的國際人士交談呢？

Yeah. Thanks, Bob. So as Bob just said and as I said in my prepared remarks, TEPEZZA grew 8% year over year. And as we have also said previously, we're continuing to focus on growth coming not only from the high CAS patients, but also the 80,000 -- roughly 80,000 patients that suffer from low CAS disease.

是的。謝謝，鮑伯。正如鮑伯剛才所說，正如我在準備好的發言中所說，TEPEZZA 同比增長了 8%。正如我們之前所說，我們繼續關注的成長不僅來自高 CAS 患者，而且還關注 80,000 名——大約 80,000 名患有低 CAS 疾病的患者。

What we have learned over our time serving these patients and these prescribers is that in order to most effectively reach these low CAS patients, we need to have a dedicated effort towards both comprehensive ophthalmologists and ocular specialists as well as endocrinologists.

在為這些患者和處方醫生提供服務的過程中，我們了解到，為了最有效地接觸到這些低 CAS 患者，我們需要綜合眼科醫生、眼科專家以及內分泌科醫生的共同努力。

And what we have found is that type of coverage is necessary in order to serve the 80,000 or so low CAS disease patients that we have discussed previously. This approach reflects an optimized footprint. We believe that this approach will allow us to not only help the right physicians and new prescribers find the right patients for TEPEZZA, but also help to enable access to TEPEZZA the most appropriate way.

我們發現，為了為我們之前討論過的 80,000 名左右低 CAS 疾病患者提供服務，這種類型的保險是必要的。這種方法反映了優化的足跡。我們相信，這種方法不僅可以幫助合適的醫生和新處方者找到合適的 TEPEZZA 患者，還有助於以最合適的方式獲得 TEPEZZA。

Finally, what I would say here is this is something that we've been working on for a little bit here. And this change occurred in the third quarter. So we do expect the momentum to play out here in the next several quarters. In the last few weeks, the teams have been actively focused on establishing new relationships with these new prescribers, and we look forward to updating you as we go.

最後，我想說的是，這是我們一直在努力的事情。而這個變化發生在第三季。因此，我們確實預計這一勢頭將在未來幾季發揮作用。在過去的幾周里，團隊一直積極致力於與這些新的處方醫生建立新的關係，我們期待隨時向您通報最新情況。

Final point on the global aspects of TEPEZZA. As you're aware, beyond the US, we are also looking forward to bringing to TEPEZZA to patients around the globe, including Japan. Japan is a really important country for us in terms of our next launch. Let me remind you that we received approval in Japan for TEPEZZA with high CAS patients in September, and we're actively working to an early 2025 launch there as well.

關於 TEPEZZA 的全球方面的最後一點。如您所知，除了美國之外，我們還期待將 TEPEZZA 帶給包括日本在內的全球患者。就我們的下一次發布而言，日本對我們來說是一個非常重要的國家。讓我提醒您，我們在 9 月於日本獲得了用於治療高 CAS 患者的 TEPEZZA 的批准，我們也正在積極努力於 2025 年初在日本上市。

Julianne, next question, please.

朱麗安，請下一個問題。

Umer Raffat, Evercore ISI.

烏默·拉法特，Evercore ISI。

I had a two-part question on MariTide, if I may. Perhaps, first, from a vomiting profile perspective, I recall in the Phase 1 trial, specifically in Phase 1, the vomiting profile was generally fairly consistent between low and high doses, which would imply perhaps titration in and of itself may not solve for vomiting. But Jay, I'm curious, is there anything super important in the design of Phase 1 which wasn't incorporated that could have addressed that vomiting, that's number one.

如果可以的話，我對 MariTide 有一個由兩個部分組成的問題。也許，首先，從嘔吐特徵的角度來看，我記得在第一階段試驗中，特別是在第一階段，低劑量和高劑量之間的嘔吐特徵通常相當一致，這意味著滴定本身可能無法解決嘔吐問題。但是傑伊，我很好奇，在第一階段的設計中是否有任何非常重要的東西沒有被納入，可以解決嘔吐問題，這是第一。

And then secondly, on the cadence of weight loss, is there any reason to expect the plateau in weight loss to not happen before -- do not happen past month seven or so because we've seen other GLP trials kind of do that in six to seven months post titration.

其次，關於減肥的節奏，是否有任何理由預計減肥的穩定期不會發生在過去的第七個月左右，因為我們已經看到其他 GLP 試驗在六個月內就做到了這一點至滴定後七個月。

Yeah. Thanks, Umer. I really appreciate it. The Phase 1 study published now in January has been pretty thoroughly considered. This was a standard Phase 1 dose escalation study that did not have antecedent dose titration.

是的。謝謝，烏默。我真的很感激。一月份發表的第一階段研究已經經過了相當徹底的考慮。這是一項標準的第 1 期劑量遞增研究，沒有事前劑量滴定。

So if that answers your question, I suppose there's only so much that can be learned from the Phase 1. We're honestly just really focused on these Phase 2 data, where at the interim, we saw the differentiated profile.

因此，如果這回答了您的問題，我想從第一階段可以學到的東西就這麼多。 。

And as you know, we're in Phase 3 planning. Regarding weight loss plateau, this will be an interesting thing to observe and learn from the data, which we wait later this year.

如您所知，我們正在進行第三階段規劃。關於減肥平台期，這將是一件值得觀察和學習的有趣的事情，我們將在今年晚些時候等待。

Julianne, next question, please.

朱麗安，請下一個問題。

Jay Olson, Oppenheimer.

傑·奧爾森，奧本海默。

Congrats on the quarter. Maybe I'll shift gears to oncology. Congrats on all the progress and impressive growth, especially for BLINCYTO. For subcu BLINCYTO, it looks like the registrational study is now going to initiate in the second half of next year. Can you talk about what may have changed there and maybe share some color on the plans for that study?

恭喜本季。也許我會轉向腫瘤學。恭喜所有的進步和令人矚目的成長，特別是 BLINCYTO。對於 subcu BLINCYTO，看起來註冊研究將於明年下半年啟動。您能談談那裡可能發生的變化嗎？

Yeah. Thanks, Jay. This is Jay. The subcutaneous development of BLINCYTO is a major priority for us. We're very encouraged by the efficacy that we've seen with subcutaneous BLINCYTO in prior studies.

是的。謝謝，傑伊。這是傑伊。 BLINCYTO 的皮下開發是我們的首要任務。我們對在先前的研究中看到的皮下 BLINCYTO 的功效感到非常鼓舞。

You'll remember perhaps that this medicine is dosed three times a week. We did a Phase 1 study back in 2022 at ASH with striking data. Among 21 evaluable patients, we saw 67% CR rate within one cycle.

您也許會記得這種藥每週服用三次。我們早在 2022 年就在 ASH 進行了一項第一階段研究，並獲得了驚人的數據。在 21 位可評估的患者中，我們看到一個週期內的 CR 率為 67%。

There's been further data in the American Journal of Hematology since that time, 27 patients with an 85% CR rate, 75% of whom were MRD negative. And this is all without any grade for CRS. So subcutaneous BLINCYTO was a major priority for us. It is progressing in clinical investigation. And there's really nothing to read into the timing that you allude to in your excellent question.

此後《美國血液學雜誌》上有進一步的數據，27 名患者的 CR 率為 85%，其中 75% 的 MRD 陰性。而這一切對 CRS 來說都是沒有任何等級的。因此，皮下注射 BLINCYTO 是我們的首要任務。臨床研究正在取得進展。對於您在出色的問題中提到的時間安排，確實沒有什麼可解讀的。

Julianne, next question, please.

朱麗安，請下一個問題。

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

Two-part on MariTide as well. Just wondering if you can confirm if the data disclosure will be a press release or it will be at a conference. I think the Phase 1 data were presented at the insulin resistance conference in December. So just wondering the venue.

MariTide 上也分為兩部分。只是想知道您是否可以確認數據披露將是新聞稿還是會議。我認為第一階段的數據是在 12 月的胰島素抗性會議上公佈的。所以只是想知道場地。

And then for the Phase 3, Jay, do you think you're going to have to make any changes to the titration schedule you employed in Phase 2? I know Lilly had extended their tirzepatide titration schedule when they move from Phase 2 to Phase 3. Do you think that's something that could be necessary here?

然後，對於第三階段，Jay，您認為您是否需要對第二階段採用的滴定方案進行任何更改？我知道禮來公司在從第 2 階段進入第 3 階段時延長了他們的替澤帕肽滴定時間表。

In terms of the release, Terence, and how we share that with investors. Well, again, we're focused on getting the data in hand and when we have them, we'll try to do whatever in best interest of the shareholders. So stay tuned as soon as we have them. We look forward to being able to report those. And Jay, do you want to address the question on Phase 3?

關於發布，特倫斯，以及我們如何與投資者分享。好吧，再說一遍，我們專注於獲取手中的數據，當我們掌握這些數據時，我們將盡力做任何符合股東最大利益的事情。因此，一旦我們有了它們，請立即關注。我們期待能夠報告這些情況。 Jay，你想回答第三階段的問題嗎？

The Phase 3 planning, as we've shared, is fully on track, and we won't today give any news or insights into our approach to dosing, but we feel confident it will be well informed by the Phase 2 study that is ongoing, and we'll read out later this year.

正如我們所分享的，第三階段計劃已完全步入正軌，今天我們不會就我們的劑量方法提供任何新聞或見解，但我們相信正在進行的第二階段研究將為其提供充分的信息，我們將在今年晚些時候宣讀。

Next question, please, Julianne.

請下一個問題，朱麗安。

Carter Gould, Barclays.

卡特·古爾德，巴克萊銀行。

I want to maybe switch it up a little bit and ask you around the PAVBLU launch. Amgen's biosimilars have some have gone really well, others a little bit less so. You've historically talked about the importance of being first. But how do you think about adoption ahead of a Q code and in discussions with any payers, your expectation or step edits for biosimilars ahead of some of the other newer entrants?

我想稍微改變一下，向您詢問有關 PAVBLU 發布的情況。安進的生物相似藥有一些效果非常好，而有些則稍差一些。您歷來都談到成為第一的重要性。但是，您如何看待 Q 代碼之前的採用以及與任何付款人的討論，您對生物仿製藥的期望或步驟編輯領先於其他一些新進入者？

Yeah. Thanks, Carter. Murdo, why don't you share your thoughts in general on the biosimilar franchise. We don't often get a chance to talk about it, but please also on PAVBLU.

是的。謝謝，卡特。 Murdo，為什麼不分享一下您對生物相似藥系列的整體看法呢？我們不經常有機會談論它，但也請在 PAVBLU 上討論。

Thanks, Bob. We're obviously quite excited about the next wave of launch is not just PAVBLU, but our other biosimilar launches that we are expecting in the not-too-distant future, as I mentioned in my opening remarks, with WEZLANA and BEKEMV.

謝謝，鮑伯。顯然，我們對下一波的推出感到非常興奮，不僅是 PAVBLU，還有我們預計在不久的將來推出的其他生物仿製藥，正如我在開場白中提到的 WEZLANA 和 BEKEMV。

On PAVBLU, as you mentioned, Carter, it's important to be first or in the first wave. And clearly, we're in that position now as we're launching this product as we speak. And we expect there to be strong interest in PAVBLU pretty much early on in the launch phase. Obviously, having permanent Q codes in this case, given that it's biosimilar are important, but there's a lot of interest out there even as we may have a temporary reimbursement code.

在 PAVBLU 上，正如您所提到的，卡特，成為第一或第一波非常重要。顯然，我們現在正處於這樣的境地，因為我們正在推出這款產品。我們預計 PAVBLU 在發布階段的早期就會引起人們的濃厚興趣。顯然，在這種情況下擁有永久 Q 代碼（考慮到它是生物仿製藥）很重要，但即使我們可能有臨時報銷代碼，人們也很感興趣。

And generally, Carter, as we've built what we think is industry-leading biosimilar franchise. It's a franchise that is performing very well, and we think it's earning attractive returns for our shareholders.

總的來說，卡特，我們已經建立了我們認為行業領先的生物仿製藥特許經營權。這是一個表現非常好的特許經營權，我們認為它為我們的股東帶來了有吸引力的回報。

Next question, please.

請下一個問題。

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

Just a quick question on TEZSPIRE in COPD. Obviously, some really nice Phase 2 data earlier this year, but just was interested of how you think about the potential landscape here as we consider both DUPIXENT potentially the IL-33 is coming to market ahead of you. It seems like you might have a broader program and some interesting data. But just help me a little bit about how you're just commercially seeing that fitting into the landscape.

關於 TEZSPIRE 治療慢性阻塞性肺病 (COPD) 的一個簡單問題。顯然，今年早些時候有一些非常好的第二階段數據，但我只是想知道您如何看待這裡的潛在前景，因為我們認為 DUPIXENT 和 IL-33 都可能先於您進入市場。看起來您可能有更廣泛的計劃和一些有趣的數據。但請幫助我了解您如何在商業上看到它融入景觀。

Well, Chris, why don't I start and this is Jay and Murdo hand off to you. So TEZSPIRE, as all here knows our TSLP monoclonal antibody that we're developing with AstraZeneca. And recently, we had a chance to read out a very compelling Phase 2 study in moderate to very severe COPD. This is a 337-patient study. These patients were having exacerbations despite triple therapy.

好吧，克里斯，我為什麼不開始呢，這是傑伊和默多交給你的。 TEZSPIRE，這裡的所有人都知道我們正在與阿斯特捷利康一起開發的 TSLP 單株抗體。最近，我們有機會宣讀了一項非常引人注目的針對中度至極重度慢性阻塞性肺病的 2 期研究。這是一項 337 名患者的研究。儘管進行了三重治療，這些患者的病情仍惡化。

And we went head-to-head against placebo over a 52-week period of time. The population actually broader even than DUPI and Murdo perhaps invite you to reflect on that. The data were quite positive with a numerically reduced exacerbation rate by 17%.

我們在 52 週的時間裡與安慰劑進行了正面交鋒。實際上，人口甚至比 DUPI 和 Murdo 還要廣泛，也許會讓你反思這一點。數據非常積極，惡化率在數值上降低了 17%。

We learned a lot from biomarker studies of blood eosinophils as to which subsets of patients, all pre-planned stand to benefit the most. And with these learnings, we're now pleased to announce that we're planning to initiate Phase 3 studies together with AstraZeneca. This trial is well structured and set up to definitively answer the question around efficacy TEZSPIRE in COPD.

我們從血液嗜酸性粒細胞生物標記研究中學到了很多關於哪些患者亞群（所有預先計劃的患者亞群）將受益最多的資訊。有了這些經驗，我們現在很高興地宣布，我們計劃與阿斯特捷利康一起啟動第三階段研究。本試驗結構合理，旨在明確回答有關 TEZSPIRE 對 COPD 療效的問題。

And Murdo, would you like to reflect a little bit about our competitive posture?

默多，您想反思一下我們的競爭態勢嗎？

Yeah. Thanks for the question, Chris. We're obviously really pleased with the performance of TEZSPIRE so far in uncontrolled -- severe uncontrolled asthma. We're actually now the second most prescribed product when it comes to new-to-brand prescriptions in that category. So I think it's clear now that allergists and pulmonologists appreciate the differentiated profile and the unique mechanism of action that is TEZSPIRE.

是的。謝謝你的提問，克里斯。顯然，我們對 TEZSPIRE 迄今為止在不受控制的嚴重不受控制的氣喘方面的表現感到非常滿意。實際上，就該類別中的新品牌處方而言，我們現在是第二大處方產品。因此，我認為現在很明顯，過敏症專家和肺部疾病專家讚賞 TEZSPIRE 的差異化特徵和獨特的作用機制。

And we also believe, as Jay has highlighted that, that ability to address a broader population of patients because of the unique mechanism of action and the upstream way in which it intervenes in the immuno inflammation cascade. We're hopeful that that differentiation will continue to play out in COPD, and we feel really good about the opportunity to compete there.

正如傑伊所強調的那樣，我們也相信，由於其獨特的作用機制及其乾預免疫發炎級聯的上游方式，這種能力能夠解決更廣泛的患者群體。我們希望這種差異化將繼續在慢性阻塞性肺病領域發揮作用，我們對在那裡競爭的機會感到非常高興。

With the combined resources of our partners at AstraZeneca and Amgen, we have a very strong share of voice currently in severe uncontrolled asthma, and we expect to be able to affect that same strong share of voice on the successful completion of the Phase 3 trial.

憑藉我們在阿斯特捷利康和安進的合作夥伴的綜合資源，我們目前在嚴重不受控制的氣喘方面擁有非常強大的話語權，並且我們期望能夠在成功完成第三階段試驗後影響同樣強大的話語權。

Julianne, let's take the next question, please.

朱麗安，請讓我們回答下一個問題。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO 資本市場。

I want to touch on the biosimilar launch for the [ecosystem] biosimilar. Maybe talk about some of the launch strategy and more specifically, how you can stimulate demand among Ophtalmologists who would otherwise use a branded product. Are you able to offer rebates or extended invoicing for these practices?

我想談談[生態系統]生物相似藥的生物相似藥的推出。也許可以談談一些發布策略，更具體地說，如何刺激眼科醫生的需求，否則他們會使用品牌產品。您能為這些做法提供回扣或延長發票嗎？

Thanks for the question. Obviously, I'm not going to talk about what we're doing commercially with respect to contracting. I will just say that we have a very broad deployed field force covering the key customers in this therapeutic area. We have very strong institutional organization that covers the purchasing groups and the large networks that treat a large percentage of the populations here.

謝謝你的提問。顯然，我不會談論我們在共同方面所做的商業活動。我只想說，我們部署了非常廣泛的現場人員，涵蓋了該治療領域的主要客戶。我們擁有非常強大的機構組織，涵蓋採購團體和服務這裡大部分人口的大型網絡。

And the receptivity has been high. This isn't our first biosimilar launch, and we've been preparing effectively, and we're excited to be in the market.

而且接受度一直都很高。這不是我們第一次推出生物相似藥，我們一直在有效地準備，我們很高興能進入市場。

Julianne, next question, please.

朱麗安，請下一個問題。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Congrats on the quarter. Maybe a question for Jay. So given that you have diabetes patients with obesity in the ongoing Phase 2 trial, do you think you would be able to look into the A1C profile of the drug as well? Or is it just too small a trial to make any conclusion about that at this point?

恭喜本季。也許有個問題想問傑伊。因此，考慮到正在進行的 2 期試驗中有患有肥胖症的糖尿病患者，您認為您也能夠研究該藥物的 A1C 特徵嗎？還是目前的試驗規模太小，無法得出任何結論？

Yes. Thank you, Mohit. As you know, type 2 diabetes runs regrettably with obesity and with overweight. And so we do hope and expect to have some insights into diabetic -- anti-diabetic activity from the Phase 2 study, but we need to have an experience in a dedicated Phase 2 study of diabetes, in particular, in patients without obesity. So more to follow there towards later this year.

是的。謝謝你，莫希特。如您所知，令人遺憾的是，2 型糖尿病與肥胖和超重有關。因此，我們確實希望並期望從第二階段研究中獲得一些關於糖尿病的見解——抗糖尿病活性，但我們需要在專門的糖尿病第二階段研究中擁有經驗，特別是在非肥胖患者中。今年晚些時候還會有更多後續活動。

Next question, please, Julliane.

請下一個問題，朱麗安。

Yaron Werber, TD Cowen.

亞龍·韋伯，TD·考恩。

Murdo, I got maybe a couple of questions for you. One, just on Enbrel, this quarter was that we didn't see the normal Q3 bounce back. It's just this a new normal now? Or is there any particular one-timers in the quarter?

默多，我可能有幾個問題想問你。第一，就 Enbrel 而言，本季我們沒有看到正常的第三季反彈。現在這只是新常態嗎？或者本季有什麼特別的一次性事件嗎？

And then secondly, you mentioned 12,000 accounts or 13,000 accounts ordering Prolia. I presume you're mentioning that on purpose is relating to the upcoming biosimilar launches late May next year. Can you talk about maybe just that dynamic in Prolia versus XGEVA, what to expect next year?

其次，您提到有 12,000 個帳戶或 13,000 個帳戶訂購 Prolia。我猜你是故意提到與明年五月底即將推出的生物相似藥有關。您能否談談 Prolia 與 XGEVA 之間的動態，明年會發生什麼事？

Thanks for the question, Yaron. Yes, as you picked up, Enbrel was impacted by two negative trends in the quarter. One, of course, the regular decline in net price and then another one, which was a 30% adjustment in the quarter. So the quarter is a little softer than you normally see. Volume was up 4% in the quarter. So Enbrel continues to do quite well in terms of prescribers treating patients but we are expecting continued net price declines going forward.

謝謝你的提問，亞龍。是的，如您所知，Enbrel 在本季度受到了兩個負面趨勢的影響。當然，一是淨價定期下降，二是本季調整了 30%。因此，本季的情況比您通常看到的要軟一些。本季成交量成長 4%。因此，Enbrel 在處方者治療患者方面繼續表現良好，但我們預計未來淨價將持續下降。

When we look at Prolia, I mentioned that we have 13,000 provider accounts having treated patients with Prolia so far this year. This is just to give an idea of the breadth and utility of this important product. The other thing that we enjoy with Prolia is it's an important way for us to source potential patients for EVENITY, which we continue to see very strong growth in.

當我們查看 Prolia 時，我提到今年到目前為止，我們有 13,000 個提供者帳戶使用 Prolia 治療過患者。這只是為了讓您了解這個重要產品的廣度和實用性。我們喜歡 Prolia 的另一件事是，它是我們為 EVENITY 尋找潛在患者的重要方式，我們繼續看到 EVENITY 的強勁成長。

So our presence in the bone community and the treating physician population that treat the many women who are trying to reduce their risk of fracture despite the effect of their osteoporosis, we feel really good about it. And yes, it could end up becoming something that helps us in terms of market presence in the face of biosimilar competition in the future.

因此，我們在骨骼界的存在以及治療許多女性的治療醫生群體，儘管她們受到骨質疏鬆症的影響，但仍試圖降低骨折風險，我們對此感到非常滿意。是的，它最終可能會成為幫助我們在未來面對生物相似藥競爭時佔據市場份額的東西。

Julliane. Let's take the next question, please.

茱麗安.請讓我們回答下一個問題。

Gregory Renza, RBC Capital Markets.

格雷戈里·倫扎（Gregory Renza），加拿大皇家銀行資本市場部。

Bob, maybe just looking at the rare disease franchise. And we've always mentioned -- you've mentioned it's certainly a different approach in this space. And to that, what is Amgen's approach on pipeline replenishment when it comes to the rare disease pillar? Certainly, being [full-packed with parents], discontinuation in IPF, just curious how to think about specific disease areas in rare disease and also how you think about kind of supporting and following your current marketed products in the rare disease franchise.

鮑勃，也許只是在關注罕見疾病專營權。我們總是提到——你也提到這在這個領域肯定是一種不同的方法。對此，在罕見疾病支柱方面，安進的管道補充方法是什麼？當然，[與父母一起]、IPF 的終止，只是好奇如何考慮罕見疾病的特定疾病領域，以及您如何考慮支持和追蹤您目前在罕見疾病特許經營中銷售的產品。

Yeah. We take this in a couple of pieces. And we're obviously very excited about rare disease and what we think we can bring to the field. With respect to the molecules that are already on the market, each of them, as you know, is in an early stage of this life cycle and involves either diseases or molecular attributes that we think we can add a lot of value to over time. So we're excited about what we think we can do with those domestically and in international markets.

是的。我們把它分成幾個部分。我們顯然對罕見疾病以及我們認為可以為該領域帶來的東西感到非常興奮。對於已經上市的分子，如您所知，它們中的每一個都處於該生命週期的早期階段，並且涉及疾病或分子屬性，我們認為隨著時間的推移，我們可以為其增加很多價值。因此，我們對在國內和國際市場上可以做的事情感到興奮。

And we're also excited about, frankly, how our genetics resource, which you're familiar with has enabled us to glean insights both from existing molecules in the rare disease portfolio as well as potentially others that we might be able to add to it. But I'd invite Jay to share his thoughts. He's already brought a lot of energy to this topic with our rare disease organization.

坦白說，我們也很興奮，您所熟悉的遺傳資源使我們能夠從罕見疾病組合中的現有分子以及我們可能添加到其中的其他潛在分子中收集見解。但我會邀請傑伊分享他的想法。他已經在我們的罕見疾病組織中為這個話題投入了大量的精力。

So, Jay, fire away.

所以，傑伊，開火吧。

Thanks, Bob, and thanks for Gregory for the question. The acquisition of Horizon has really activated and energized our staff in R&D. I think inspired by the mechanistic repositioning of a TEPEZZA for thyroid eye disease, the capacity to bring rare disease medicines expertly to patients around the world has really activated the imagination of our R&D colleagues. And we've had multiple new project launches since the acquisition of Horizon.

謝謝鮑勃，也謝謝格雷戈里提出的問題。收購Horizo​​​​n確實激活了我們研發人員的活力。我認為，受到 TEPEZZA 對甲狀腺眼疾的機制重新定位的啟發，為世界各地的患者提供專業的罕見疾病藥物的能力確實激發了我們研發同事的想像力。自從收購 Horizo​​​​n 以來，我們已經啟動了多個新專案。

Second, I would say that the integration has gone very smoothly. And the staff who've joined us through the Horizon acquisition have both seamlessly executed the development priorities for the rare disease portfolio and also have brought a lot of really interesting ideas. We have now a rare disease initiative with dedicated leadership.

第二，我想說，整合進展非常順利。透過 Horizo​​n 收購加入我們的員工不僅無縫地執行了罕見疾病產品組合的開發優先事項，還帶來了許多非常有趣的想法。我們現在有一個罕見疾病倡議，並有專門的領導。

We have dedicated leadership in rare disease drug development. And we hope and expect to continue just the best-in-class external innovation that Horizon was really known for in this space. So a blend of internal and external innovation will, I think, more than replenish the rare disease mid- and early-stage pipeline in the years to come.

我們在罕見疾病藥物開發方面擁有專門的領導力。我們希望並期望能夠繼續 Horizo​​​​n 在這個領域真正聞名的一流外部創新。因此，我認為，內部和外部創新的結合將不僅僅是補充未來幾年罕見疾病中早期的產品線。

We're also very excited about the talent that joined us from Horizon, particularly on the research and the medical side. So we feel really well equipped now to continue to invest in this area and make a difference for patients.

我們也對 Horizo​​​​n 的人才加入我們感到非常興奮，特別是在研究和醫療方面。因此，我們現在感覺自己已經做好了繼續投資這一領域並為患者帶來改變的準備。

Great. So Julianne, as we're getting to the half hour here, maybe we'll take 2 more questions.

偉大的。朱莉安，當我們進入半小時時，也許我們會再回答兩個問題。

Matt Phipps, William Blair.

馬特·菲普斯，威廉·布萊爾。

Just wanted to confirm if the 420-mg dose is that's going to be taken COPD trials. And is that something that you can formulate into a single injection given it's twice, I believe the current size? And then just to confirm, this is two separate Phase 3 trial? Will they be identical in design?

只是想確認 420 毫克劑量是否會用於 COPD 試驗。鑑於目前的規模是兩倍，您是否可以將其配製為單次注射？然後確認一下，這是兩個獨立的第三階段試驗？它們的設計相同嗎？

Yeah, Matt, thanks for the question. They're good questions, but none that we can address here today. Together with our colleagues from AstraZeneca, we'll have a chance to describe in full the design of the Phase 3 program that will support the consideration of TEZSPIRE and COPD soon to come.

是的，馬特，謝謝你的提問。這些都是很好的問題，但我們今天無法在這裡解決。我們將有機會與阿斯特捷利康的同事一起完整描述第 3 階段計劃的設計，該計劃將支持即將到來的 TEZSPIRE 和 COPD 的考慮。

All right, Julianne. I think we have time for one more.

好吧，朱麗安。我想我們還有時間再談一談。

Chris Raymond, Piper Sandler.

克里斯·雷蒙德，派珀·桑德勒。

Just back on PAVBLU. We've gotten some interesting doc feedback on this with a decent amount of receptivity to this option. And one thing that's a new development, I think, at least in the US market has been a recent supply disruption to Avastin which may actually provide maybe more of an opening for this launch.

剛回到 PAVBLU。我們收到了一些有趣的文件回饋，對此選項有相當多的接受度。我認為，至少在美國市場，最近出現的阿瓦斯汀供應中斷是一個新的發展，這實際上可能為這次發布提供更多的機會。

Maybe just curious, as you looked at the market, talk about how you looked at the role of biosimilars in this predominantly buy and bill market with a very inexpensive option on Avastin, but one that seems to be fading at least in terms of suppliers wanting to provide the drug I guess, bottom line, does this Avastin supply issue make this even more interesting to you guys?

也許只是好奇，當您觀察市場時，請談談您如何看待生物仿製藥在這個以購買和賬單為主的市場中的作用，阿瓦斯汀是一種非常便宜的選擇，但至少在供應商想要的方面，這種生物相似藥似乎正在逐漸消失。

Thanks for the question, Chris. But first and foremost, obviously, when you're treating serious illness, you want to have -- as a provider, you want to have a reliable supply of the product that you and your staff get used to handling. And I can say we are very fortunate to have world-class manufacturing here at Amgen, and we continue to have a highly reliable supply chain and manufacturing capability.

謝謝你的提問，克里斯。但首先也是最重要的是，顯然，當您治療嚴重疾病時，作為提供者，您希望獲得您和您的員工習慣處理的可靠產品供應。我可以說，我們非常幸運能夠在安進擁有世界一流的製造能力，並且我們將繼續擁有高度可靠的供應鏈和製造能力。

We have benefited from shortages with other biosimilars including Avastin. As I'll remind you, we have MVASI, our own biosimilar to that product. So we are seeing customers coming to us given some shortages here in the US and around the world.

我們受益於包括阿瓦斯汀在內的其他生物相似藥的短缺。我要提醒您的是，我們有 MVASI，我們自己的該產品的生物相似藥。因此，鑑於美國和世界各地的一些短缺，我們看到客戶來找我們。

And again, I'm thankful for our manufacturing colleagues here at Amgen who are putting us in a very strong position to be able to speak to institutional customers to individual providers and obviously communicate with patients about the ability for us to supply and the reliability of that over time. That being said, I think we're definitely looking at our own opportunity here in the market with PAVBLU.

再次，我感謝安進的製造同事，他們使我們處於非常有利的地位，能夠與機構客戶和個體提供者進行對話，並與患者就我們的供應能力和可靠性進行溝通隨著時間的推移。話雖如此，我認為我們肯定會透過 PAVBLU 在市場上尋找自己的機會。

I think you mentioned that there's high interest in the customers that you've talked to. These retina specialists are sophisticated customers. They understand that if they're going to go with a manufacturer, they're going to want a relationship that is persistent over time, and we believe we're well positioned for that. We have a great device in a prefilled syringe.

我想你提到過，與你交談過的客戶非常感興趣。這些視網膜專家都是經驗豐富的客戶。他們明白，如果他們要與製造商合作，他們會想要一種長期持續的關係，我們相信我們已經做好了充分的準備。我們有一個很棒的預充式註射器裝置。

We also have vials. So we're able to supply this demand in this market. And that's what we intend to do, and that's what our teams are in the field establishing right now. But thanks for your interest.

我們也有小瓶子。所以我們能夠滿足這個市場的需求。這就是我們打算做的事情，這就是我們的團隊目前正在該領域建立的目標。但感謝您的興趣。

Okay, Julianne, thanks for moderating our call, and thank you all for joining us. If there were any of you who didn't get a chance to ask your questions, Justin and his team will be around still for a few more hours. So we look forward to gathering with you when we next have relevant information. Thank you very much. Bye-bye.

好的，朱麗安，感謝您主持我們的電話會議，也感謝大家加入我們。如果你們中有人沒有機會提出問題，賈斯汀和他的團隊將在幾個小時內保持靜止。因此，我們期待下次有相關資訊時與您相聚。非常感謝。再見。

This concludes our 2024 Q3 earnings call. You may now disconnect.

我們的 2024 年第三季財報電話會議到此結束。您現在可以斷開連線。