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 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.

謝謝你，茱麗安。大家下午好，歡迎參加我們的 2024 年第二季財報電話會議。鮑勃·布拉德威(Bob Bradway) 將主持此次電話會議，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。我們也將做出一些前瞻性陳述，這些陳述符合我們的安全港聲明。請注意，實際結果可能會大不相同。

Over to you, Bob.

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。好吧，謝謝你，賈斯汀，讓我感謝大家今天加入電話會議。鑑於市場的波動，我們特別感謝您抽出時間與我們在一起。所以謝謝。

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，我們對實現有吸引力的長期成長的能力仍然充滿信心。我們一如既往地取得了強勁成果，即提供創新藥物來應對挑戰性疾病。

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, an 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.

從市場投資組合開始。第二季營收成長 20%，達到 84 億美元，眾多藥品實現了兩位數的銷售成長。包括普通醫學領域的 Repatha 和 EVENITY，當然還有腫瘤學領域的 BLINCYTO、發炎領域的 TEZSPIRE，然後轉向罕見疾病領域，該季度的銷售額超過 10 億美元。我要強調的是，KRYSTEXXA、UPLIZNA 和 TAVNEOS 在本季度均實現了至少兩位數的銷售額成長，TEPEZZA 年比成長 8%，季增 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.

所有這些首創或同類最佳藥物仍處於生命週期的早期階段，並且有足夠的空間來進行地理擴張、新適應症和/或新配方。您很快就會聽到有關這些品牌的更多資訊。

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. We are, so far, so good.

轉向研究和開發。我們相信我們的產品線看起來也非常有前途，不僅在肥胖方面，而且在我們所有的治療領域。我們在今年年初告訴您，我們預計 2024 年將實現十幾個重要的管道里程碑。

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，這是一種具有里程碑意義的小細胞肺癌新藥。事實上，自批准以來與我交談過的醫生都對這種藥物感到非常興奮，因為它是幾十年來第一個對這些患者有意義的創新。基於顯著提高的總體存活率，我們也獲得了 BLINCYTO 用於 B 細胞前體急性淋巴性白血病一線治療的批准。一線批准有意義地擴大了 BLINCYTO 對所有 B-ALL 患者的潛在影響。

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.

我們宣布了 UPLIZNA 在 IgG4 相關疾病中令人印象深刻的 3 期數據，這是一種嚴重的疾病，目前還沒有任何類型的批准療法。以我們在 TEZSPIRE 治療嚴重氣喘方面的成功為基礎。我們宣布了針對慢性阻塞性肺病患者的 2 期研究的令人興奮的數據，該研究贏得了這項分子突破性療法的稱號。

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.

慢性阻塞性肺病是世界第三大死因，非常需要新的治療方案。我們期待今年稍後在治療領域獲得更多數據，當然，重點是正在進行的 MariTide 2 期研究的頂線數據。我們對該領域的新數據感到鼓舞，特別是在我們長期戰略重點的心血管和腎臟疾病領域。

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.

我們專注於準備啟動廣泛的 MariTide 3 期計劃，其中包括肥胖、肥胖相關疾病和 2 型糖尿病，我們正在進一步加強投資力度，以支持 MariTide 的其餘項目。您很快就會在本次電話會議上聽到有關該管道的更多資訊。

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，這對我們安進來說是一個非常激動人心的時刻，並且一如既往，我感謝世界各地的安進同事對患者的持久承諾。

And now let me turn things over to Murdo.

現在讓我把事情交給默多。

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，帶動銷售額較去年同期成長 20%。我們所有的地區都實現了引人注目的成長。 12種產品的銷售額成長了至少兩位數，包括Repatha、TEZSPIRE、EVENITY、TAVNEOS和BLINCYTO，所有這些品牌對我們未來的成長都很重要。

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.

從我們的普通藥品組合開始。在銷售成長的推動下，Repatha、EVENITY 和 Prolia 第二季銷售額年增 20%。第二季 Repatha 銷售額年增 25% 至 5.32 億美元。現在，它正在成為一家價值數十億美元的企業。

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.

本季度，銷量年增 46%，但部分被淨售價下降所抵銷。在美國，我們看到醫療保健提供者、付款人和患者越來越認識到降低 LDL 膽固醇的重要性，這顯著加速了 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範圍，並取消了多個付款人的事先授權要求。在最近的一項調查中，大約 95% 的心臟科醫生表示 Repatha 易於使用，並且與兩年前相比，使用率有了顯著改善。

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.

EVENITY 第二季銷售額年增 39%，達到 3.91 億美元。在美國，現有 EVENITY 處方者的處方量增加和新處方者的擴張都支持了銷售的成長。

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，迄今為止，EVENITY 已為約 60 萬名患者開立處方，並繼續以 45% 的成骨劑市場份額佔據該細分市場的領先地位。由於停經後骨質疏鬆症，許多女性仍然面臨骨折的風險。我們對所推動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 superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis at high risk of fracture.

Prolia 第二季銷售額年增 13%，達到 12 億美元。現實世界的證據繼續支持體積增長，證明在患有骨折高風險停經後骨質疏鬆症的初治患者中，與阿崙膦酸鈉相比，Prolia 在降低骨折風險方面具有優越性。

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.

在發炎領域，TEZSPIRE 繼續保持強勁勢頭，第二季銷售額達 2.34 億美元。銷售額年增 76%，這主要是由預裝一次性筆的使用所推動的。鑑於 TEZSPIRE 獨特的差異化特徵及其治療全球 250 萬嚴重不受控制的氣喘患者的巨大潛力，我們看到了 TEZSPIRE 的強勁成長機會。

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.

Otezla 第二季銷售額年減 9%，銷量成長 2%，但被淨售價下降和預計銷售扣除額的不利變化所抵銷。在美國，本季新患者處方量年增 3%，這得益於我們皮膚科銷售人員的強勁執行力以及 Otezla 直接面向消費者的媒體活動的增加。

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 cirrhosis.

隨著新型外用藥和新生物療法的推出，我們看到皮膚病學領域的競爭日益激烈。鑑於 Otezla 廣泛的標籤、安全性以及作為肝硬化患者首選全身治療選擇的獨特定位，Otezla 在這一領域保持著重要作用。

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.

Enbrel 第二季銷售額年減 15%，主要是淨售價下降。展望未來，我們預期淨售價將持續下降，銷售量將相對持平。 Enbrel 以其功效而聞名，深受醫生信賴。其巨大的健康效益和現金流的產生為我們的業務奠定了堅實的基礎。

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 BEKEMV, 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.

現在轉向生物相似藥，第二季度我們的生物相似藥產品的銷售年比相對穩定。我們為未來的成長做好了準備，即將推出的產品包括[Stelara] 的生物相似藥WEZLANA 和Soliris 的生物相似藥BEKEMV，預計將於2025 年第一季在美國上市。業務模式可確保效率並提供有吸引力的產品股東的現金流量和回報。

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 prices. In total, these products contributed almost $2 billion of sales in the second quarter.

在腫瘤學領域，我們的七種創新產品 BLINCYTO、LUMAKRAS、Vectibix、KYPROLIS、Nplate、XGEVA 和 IMDELLTRA 第二季度的銷售額年增 12%。受銷量成長和淨售價上漲的推動。這些產品在第二季度總共貢獻了近 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.

在學術界和社區領域針對 B 細胞 ALL 患者的廣泛處方的推動下，第二季度 BLINCYTO 銷售額年增 28%，達到 2.64 億美元。 BLINCYTO 最近獲得美國食品和藥物管理局批准，作為費城染色體陰性 B 細胞 ALL 患者的一線鞏固治療。我們的商業和醫療團隊正在與主要學術、區域和社區客戶合作，將 BLINCYTO 建立為這種情況下的護理標準。

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. Back to back 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 未來的成長機會來自於新市場的推出和其他適應症。第二季背對背銷售額年增 9%，達到 2.7 億美元，目前年化銷售額超過 10 億美元。我們也推動了 KYPROLIS 和 Nplate 的強勁業績，前者較去年同期成長 9%，後者較去年同期成長 12%。

Since our US 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，我們第二季的銷售額達到了 1,200 萬美元。 IMDELLTRA 最近被批准用於治療在鉑類化療期間或之後疾病進展的廣泛期小細胞肺癌成年患者。

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.

我們在學術和社區環境中看到了對 IMDELLTRA 的強烈臨床信念，雖然在推出之初，我們對 IMDELLTRA 的採用感到鼓舞，並期待它有潛力為患有這種侵襲性疾病的患者帶來新的可能性。我對本季的執行情況感到滿意，推動了我們最重要的成長品牌的加速業績​​。

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 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，該疾病在第二季度的產品銷售額超過 11 億美元。從治療甲狀腺眼疾的 TEPEZZA 開始，第二季銷售額為 4.79 億美元，年增 8%，季增 13%。與傳統 Horizo​​n 業務的結果進行比較。

Recall that there are roughly 100,000 TED patients in the US, 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.

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。主要的成長機會存在於約 80% 的 TED 患者中，他們的臨床活動評分或 CAS 較低。

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影響範圍，特別是眼科醫生和內分泌科醫生，他們管理著許多可以從 TEPEZZA 中受益的低 CAS 患者。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了解對患者的重大影響，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，我們正在加強內分泌學領域的策略重點，並配備專門的銷售團隊來參與這一重要領域。我們在改善准入方面也取得了重大進展。感謝付款人對TEPEZZA功效的認可。

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，我們已經為超過 55% 的美國受保人實現了有利的醫療政策變化，而上季度這一比例為 50%，大約一年前僅為 5%。我們預計這一勢頭將在 2024 年持續下去。預計將於2025 年初在日本進行下一個重大上市。 。

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患者的 KRYSTEXXA 在第二季度實現了 2.94 億美元的銷售額，同比增長 20%，這得益於強勁的商業執行帶來的銷量增長。具有免疫調節作用的 KRYSTEXXA 繼續重新定義不受控制的痛風的護理標準。

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.

UPLIZNA 用於治療視神經脊髓炎譜系障礙 (NMOSD) 患者，第二季銷售額為 9,200 萬美元，較去年同期成長 35%。 UPLIZNA 的國際擴張也在進行中，在美國以外的多個市場推出，其中包括今年稍早推出的加拿大。

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 US. 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 NMOSD 之外，我們也對 UPLIZNA 在 IgG4 相關疾病方面取得的令人印象深刻的 3 期結果感到興奮。它還有可能解決影響美國 20,000 多名患者的衰弱病症。我們也期待今年稍後 UPLIZNA 治療重症肌無力的 3 期結果。傑伊稍後將更詳細地討論這些問題。

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 第二季銷售額為 7,100 萬美元。在銷量成長的推動下，銷售額較去年同期成長 137%。在美國，超過 3,500 名 ANCA 相關血管炎患者接受了 TAVNEOS 治療。目前已有超過 2,300 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 35%。隨著我們利用安進在發炎領域的領導地位、世界一流的製造和工藝開發以及廣泛的全球足跡，原有 Horizo​​n 業務的整合進展順利。

Now I will pass 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 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.

謝謝維克拉姆，大家下午好。在第二季度，我們迅速推進了潛在的一流或一流專案的廣泛臨床管道。我們在本季度收到了兩項批准。突破性的治療指定並為許多項目提供了令人興奮的臨床數據，同時熱切等待今年稍後的更多數據讀數。

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.

讓我們從普通醫學開始。如前所述，根據中期分析，我們看到了 MariTide 的差異化概況，並相信它將解決肥胖、肥胖相關疾病和 2 型糖尿病方面未得到滿足的重要醫療需求。

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.

我們仍處於正軌，並期待在 2024 年底獲得正在進行的 MariTide 第 2 期研究的 52 週頂線數據。一項2 期試驗研究MariTide 用於治療肥胖和非肥胖患者的糖尿病。

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 Amgen is olpasiran, our potentially best-in-class Lp(a) targeting small interfering RNA medicine.

除了 MariTide 之外，我們還繼續推進早期肥胖計劃，其中包括口服和注射腸促胰島素以及非腸促胰島素方法。我們預計其中一個項目將在今年稍後進入臨床開發。安進還有 olpasiran，這是我們潛在的同類最佳 Lp(a) 標靶小幹擾 RNA 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.

olpasiran 完全入組的 3 期心血管結局試驗仍在持續取得進展。需要提醒的是，Lp(a) 是一種基因定義的心血管危險因素，在大約 20% 的個體中，Lp(a) 升高，且目前尚無有效或標靶治療方法。在腫瘤學領域，我們繼續透過能夠為患者帶來變革性臨床益處的差異化療法來實現高度確信的目標。

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.

讓我們從 IMDELLTRA 開始，它是我們一流的雙特異性 T 細胞接合劑或 BiTE 分子，針對 DLL3，用於治療小細胞肺癌。我們非常高興 FDA 加速批准 IMDELLTRA 用於治療在鉑類化療期間或之後疾病進展的廣泛期小細胞肺癌成年患者。

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，我們很高興 NCCN 指引已更新，將 IMDELLTRA 納入無化療間隔小於或等於 6 個月患者的首選治療方案，以及無化療間隔大於 6 個月患者的其他建議治療方案超過六個月。基於在接受二線和三線治療的患者中觀察到作為單藥的顯著活性，我們正在迅速將 IMDELLTRA 推進一線治療，並正在進行針對廣泛期和局限性疾病的三項 3 期研究。

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 and 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的驗證性第 3 期研究，已完成入組。值得注意的是，IMDELLTRA 是第一個被批准用於治療常見實體瘤的雙特異性 T 細胞接合劑。目前 tarlatamab 的早期臨床研究和較低腫瘤負荷的研究借鑒了我們在首個獲批的雙特異性 T 細胞接合劑 BLINCYTO 和 B 細胞急性淋巴細胞白血病的經驗。

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.

在這裡，我們觀察到微小殘留疾病陰性患者的總存活率顯著提高，且耐受性也得到改善。這些 BLINCYTO 數據提供的證據表明，以這種方式引導 T 細胞是發現和消除導致發生的殘留癌細胞的有效方法。

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 6 月，基於在一線疾病治療中觀察到的深遠生存獲益，FDA 批准了 BLINCYTO 的一項額外適應症，用於治療 1 個月或以上的 CD19 陽性、費城染色體陰性、B 細胞 ALL 和鞏固治療階段，這裡不考慮微小殘留疾病的狀況。我們繼續透過正在進行的研究和皮下給藥的進一步研究來擴大 BLINCYTO 對新診斷的 B-ALL 的影響。

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.

我們一流的 STEAP1 CD3 雙特異性分子 xaluritamig 在轉移性去勢抵抗性前列腺癌中也表現出了深遠的臨床活性。重要的是，證明我們有能力透過雙特異性 T 細胞接合療法靶向第二種常見實體瘤。我們正在迅速推進該計劃，目前已全面納入單藥治療 1 期劑量擴展，同時我們將繼續將患者納入減少監測和門診隊列。

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，我們正在前列腺癌治療模式的早期階段推進 Xaluritamig 的研究，將 Xaluritamig 與恩雜魯胺或阿比特龍聯合使用，同時我們計劃在早期疾病環境中進行更多研究。

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、xaluritamig 等重大進展進一步確立了我們領先的雙特異性 T 細胞接合平台的廣泛潛力。為了完善腫瘤學，我們已經完成了FORTITUDE-101 的入組，這是一項bemarituzumab 的3 期研究，bemarituzumab 是一種一流的成纖維細胞生長因子受體IIb 定向單株抗體，與一線胃癌化療聯合使用。

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.

我們也正在快速推進 AMG 193，這是我們為 MTAP 無效實體瘤開發的口服 PRMT5 抑制劑，既可以作為單一療法，也可以與其他療法合併使用。 AMG 193 在 MTAP 無效實體瘤患者中進行的 1 期劑量遞增和初始劑量擴展研究的更多數據將於 9 月在 ESMO 上公佈。最後，我們也很高興地宣布 FDA 已授予 AMG 193 用於治療胰臟癌的孤兒藥資格。

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.

轉向炎症。我們對 TEZSPIRE 對中度至極重度慢性阻塞性肺病患者的 2 期研究產生的數據感到鼓舞。我們正在與阿斯特捷利康一起積極規劃慢性阻塞性肺病的第三階段開發。

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 突破性療法稱號，作為以嗜酸性粒細胞表型為特徵的中度至極重度慢性阻塞性肺病患者的補充維持治療。

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之外，我們還在嗜酸性粒細胞性食道炎和伴有鼻息肉的慢性鼻竇炎的單獨 3 期研究中繼續探索 TEZSPIRE，預計今年晚些時候將獲得頂線數據。轉向 rocatinlimab，這是一種針對 [OX40] 受體的一流 T 細胞再平衡單株抗體。全面的 rocatinlimab 3 期 ROCKET 計畫已成功入組 3,100 多名中度至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.

八項研究中的五項現已全部入組。 3 期 HORIZON 研究是 ROCKET 計劃的一部分，該研究評估了 rocatinlimab 單藥治療與安慰劑治療中度至重度異位性皮膚炎成人的療效。預計下半年的數據讀出正在進行中。除了異位性皮膚炎之外，我們還繼續探索 rocatinlimab 在其他適應症中的潛力，並啟動了中度至重度氣喘的 2 期研究以及結節性癢疹的 3 期研究。轉向罕見疾病，我們對罕見疾病產品線的進步以及一些中後期機會感到鼓舞。

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 細胞耗竭療法，與其他自體免疫療法相比，具有獨特的作用機制、持久的療效以及方便的每六個月靜脈注射給藥方案。這對於慢性發炎性疾病可能非常重要。

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.

最近，我們很高興地宣布一項 3 期臨床試驗的積極頂線結果，該試驗評估了 UPLIZNA 治療免疫球蛋白 G4 相關疾病的有效性和安全性。該試驗達到了主要終點，顯示在 52 週安慰劑對照窗口期內，與安慰劑相比，IgG4 相關疾病發作的風險驚人地降低了 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.

所有關鍵的次要終點也都得到滿足，並且沒有發現新的安全訊號。這是第一個證明對 IgG4 相關疾病患者群體有效的隨機對照試驗，監管備案活動正在進行中，該試驗的完整數據將在未來的醫學會議上公佈。

We are also studying a 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.

我們也透過正在進行的 3 期 MINT 研究來研究 UPLIZNA 治療全身性重症肌無力的情況。 MINT 研究正在評估 UPLIZNA 對全身性重症肌無力患者的療效和安全性。他們的疾病嚴重程度和治療經驗與其他最近批准的生物療法相當。

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.

我們正在對導致這種疾病的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 UPLIZNA 進行研究。 MINT 是唯一試圖證明療效同時消除類固醇治療益處的試驗。 MINT 試驗中使用類固醇的患者有一個指定的方案，規定在 24 週內逐漸減量。我們期待2024年下半年的數據讀出。

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.

為了將我們的CD19 定向療法的影響擴大到更多患有嚴重發炎性疾病的患者，在生物學推論和CD19 定向療法小型研究的見解的推動下，我們正在啟動一項針對CD19 陽性B 細胞介導的自體免疫疾病的開發計劃與 UPLIZNA 和 blinatumomab 一起使用。

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.

這是一個令人興奮且充滿希望的領域，憑藉安進在發炎性疾病領域的強大能力和兩項特色鮮明的資產，我們完全有能力在這個快速發展的領域中處於領先地位。我們將在適當的時候對這些計劃進行更多討論。

Lastly, in May, the FDA approved BEKEMV 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，5 月，FDA 批准 BEKEMV 作為第一個與 Soliris 或 eculizumab 互換的生物相似藥。同樣在生物相似藥開發方面，ABP 234 和 KEYTRUDA 候選生物相似藥以及 OPDIVO 候選生物相似藥 ABP 206 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，我要感謝我的安進同事為面臨嚴重疾病的患者提供強烈的服務意識，在這重要的一年裡保持高度的專注和積極的合作，並透過這一年致力於擴大我們的研究和業務的影響力。

I'll now turn it over to Peter.

我現在把它交給彼得。

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.

謝謝你，傑伊。我們對第二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。在我們創新產品線和市場產品的廣度和深度的推動下，我們在四個治療領域擁有強勁的長期成長前景，為全球患有嚴重疾病的患者提供服務。

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.

從第二季業績開始，如投影片第 27 張投影片所示，我們實現了 84 億美元的總收入，年增 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有更多的患者正在接受安進（Amgen）藥物。

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.

不包括 Horizo​​n 的加入，在銷售成長 10% 的推動下，產品銷售額年增 5%。第二季度，我們的非 GAAP 營業利潤率佔產品銷售額的百分比為 48.2%，非 GAAP 營業費用總額年增 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，主要是因為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%，因為我們對後期研發管線進行了策略性投資，包括 MariTide、rocatinlimab 和 bemarituzumab 以及 Horizo​​n 收購的專案。非 GAAP SG&A 費用年增 36%，主要是由於 Horizo​​n 的加入所致。不包括 Horizo​​n 的增加，在 Repatha、Otezla 和 EVENITY 投資的推動下，非 GAAP SG&A 費用年增 14%。

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 OI&E 支出為 7 億美元，比去年同期增加 4 億美元，幾乎完全是由於 Horizo​​n 收購帶來的利息支出增加。我們仍有望實現去槓桿化，目標是到 2025 年底償還超過 100 億美元的債務。

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.

我們的非 GAAP 稅率年減 1.5 個百分點至 14.9%。主要是由於我們的地平線納入而導致銷售組合發生變化。

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，由於納稅時間的影響，該公司產生了 22 億美元的自由現金流，比前一年的 38 億美元減少了 38 億美元。 2023 年，包括我們的匯回稅在內的聯邦稅款是在第四季度繳納的。而 2024 年，這些付款是在第二季支付的。 Horizo​​n 整合進展順利，我們預計到收購後第三年稅前協同效應將達到 5 億美元，其中約 50% 將在今年年底實現。

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 年非公認會計原則每股收益將增加。我們正在內部和外部投資於最好的創新，以快速推進創新管道，跨越四個治療領域的多種潛在的一流和/或一流的藥物。

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，這反映在我們第二季非 GAAP 研發支出 14 億美元，比去年同期成長 30%。其次，我們持續投資業務以實現長期成長。我們正在擴大最先進的製造設施的產能，包括支持 MariTide 的投資。

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.

除了製造業之外，我們還將在印度海得拉巴開設一個新的全球技術和創新中心，該中心將大規模吸引人才並加速整個組織的數位化能力，包括人工智慧、數據科學、生命科學和醫療。第三，我們向股東返還了資本，第二季支付了具有競爭力的每股 2.25 美元的股息。與 2023 年相比增加了 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 in non-GAAP earnings per share between $19.10 and $20.10. I will mention a few considerations as you model the remainder of 2024.

轉向幻燈片 29 上的 2024 年業務前景。在您為 2024 年剩餘時間建模時，我將提到一些注意事項。

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.

在營收方面，我們預計第四季與第三季相比將實現中個位數成長。隨著我們進一步投資後期產品線以支持所有治療領域正在進行的多項後期研究，我們的全年非 GAAP 研發費用預計將年增 25% 以上。因此，我們現在預計全年非 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.

第三季的非公認會計原則營運支出總額預計將以與今年前兩季相似的速度成長。我們預計 OI&E 約為 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。我們繼續預計非 GAAP 稅率將在 15% 至 16% 範圍內，其中包括與 Horizo​​n 業務相關的全年收益。

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.

正如我們之前指出的，我們已啟動進一步擴大 MariTide 製造能力的活動。支持這些初步努力。我們現在預計 2024 年的資本支出為 13 億美元，而我們最新的指引為 11 億至 12 億美元。我們的長期前景依然強勁，我感謝全球 27,000 多名同事為患者服務的奉獻精神。我們的財務更新到此結束。

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

我們現在開始問答環節。朱莉安，請提醒我們的參與者這個過程。謝謝。

(Operator Instructions).

（操作員說明）。

Yaron Werber, TD Cowen.

亞龍·韋伯，TD·考恩。

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

偉大的。謝謝。非常好的結果，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 GMJ and you have a slot on October 15, at the MGFA to present the data.

傑伊，其實也許有個問題想問你。我想從 UPLIZNA 開始。我們注意到一些事情。 MINT 研究本來應該在五月中旬左右完成。安進剛剛發布了一大堆 GMJ 的新職位招聘信息，您可以在 10 月 15 日在 MGFA 上展示這些數據。

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, NMO 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?

正如您所指出的，您正在逐漸減少類固醇的劑量。這是一個不同的試驗設計，但您也進行了類固醇逐漸減量和其他兩個適應症，NMO 和 IgG4。您能談談您希望看到什麼以及您希望從數據中看到什麼嗎？

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 P] value of what, five to the [minus 7]. This was a stunning result and the first positive Phase 3 for patients with IgG4-related diseases.

謝謝 Yaron 提出問題，也感謝您如此密切地關注該計劃。我們對 UPLIZNA 感到非常興奮，這種 CD19 B 細胞消耗單株抗體顯示出非常顯著的活性。 IgG4 相關疾病的結果是一個領頭羊，並且非常引人注目，其風險比為 [0.13 P]，即 5 比 [-7]。這是一個令人震驚的結果，也是 IgG4 相關疾病患者的第一個 3 期陽性結果。

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.

正如您在問題中很好地指出的那樣，UPLIZNA 的機會之一是讓患者擺脫類固醇，因此，這也是 UPLIZNA 在該研究中 IgG4 相關疾病環境中的預定目標，就像在廣義上一樣重症肌無力設定.現在這些結果要到今年下半年才能公佈。因此，我沒有關於該時間安排的進一步更新。

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 細胞耗竭療法能夠與現有的治療方法（如類固醇和其他 B 細胞標靶療法）有本質上的區別，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, 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.感謝您提出我的問題。就在Yaron 上，您能否談談UPLIZNA 和重症肌無力的臨床標準，無論是在安慰劑調整的基礎上還是在絕對的基礎上，考慮到明顯的類固醇逐漸減少，我相信其他療法沒有包括在內他們的設計。關於本次 MGFA 科學會議，我們是否應該在演講之前期待最重要的結果？

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 on to 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，薩爾文。正如我剛才向亞龍提到的。我們不會就 UPLIZNA 研究（重症肌無力的 MINT 研究）得出結果的時間提供進一步的指導，敬請關注。而且，眾所周知，重症肌無力患者在許多個月的治療過程中反覆出現需要持續類固醇的挑戰，因此我們在這項研究中加入了逐漸減少的類固醇。今年下半年公佈的這些結果將揭示我們每六個月 UPLIZNA 在將患者從類固醇中解放出來方面是多麼成功。

Julianne, next question, please?

茱麗安，請問下一個問題嗎？

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，這並不是一個巨大的成長動力。我希望您能介紹一下您與 CMS 就 Enbrel 進行的一些談判。您的許多同行對與 CMS 協商的公平價格感到滿意。你也有同樣的感覺嗎？我還很想知道您如何看待 [D 部分] 重新設計的影響？

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.

謝謝埃文提出的問題。這裡是默多。總體而言，儘管銀屑病關節炎和類風濕關節炎市場競爭非常激烈，但 Enbrel 繼續在市場上表現良好。儘管阿達木單抗與生物相似藥正在進行所有轉換，但我們仍然擁有相對穩定的銷售量。因此，我們對處方醫生的採用以及 enbrel 安全性和耐受性的持續價值感到非常滿意，這一點在很長一段時間內已經在很多年的經驗中得到了很好的證實。

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.

CMS 流程已結束。我們確實有價格，我只是提醒您，大約 25% 的 Enbrel 收入來自 Medicare D 部分。我們繼續看到，這不是一個激勵和獎勵創新的良好機制，它不像我們通常描述的談判機制。

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.

所以我們已經完成了這個過程。我們將繼續尋求在市場上使用 Enbrel 來幫助患者並為他們提供支持，我們將密切關注 D 部分的重新設計。我們將研究 PBM 如何重新設計其處方集，我們將研究新模型如何影響患者。雖然上限可能有所幫助，但許多患者的自付費用實際上可能會增加。所以我們正在密切關注。

Julianne, next question, please?

茱麗安，請問下一個問題嗎？

Mike Yee, Jefferies.

麥克葉，杰弗里斯。

Thank you for the question.

感謝你的提問。

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 oral multiple companies are putting off. 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.

轉向肥胖。我知道你們預計在今年稍後獲得注射產品的數據，你們聲稱該產品具有差異化，因為其他競爭對手已經迅速採取行動，不僅推出了注射劑項目，而且口服產品也被多家公司推遲。考慮到其他人有多種產品已進入後期階段，您能否評論一下您對自己在這個領域的定位有何看法，以及您認為自己在這裡的定位如何（僅給出 133）。

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。為什麼我不開始，默多，也許你可以在最後補充。我們對第二階段研究的中期結果感到非常滿意。儘管自過渡以來沒有進一步的分析，但截至過渡期間，所有武器都處於活躍狀態，退出並不是問題。我們看到了 MariTide 的差異化概況，並且仍然相信該藥物可以解決肥胖、肥胖相關疾病，特別是 2 型糖尿病方面未得到滿足的重大醫療需求，正如電話會議早些時候分享的那樣。

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，這個領域有相當民主化和廣泛的創新基礎。潛在的口服藥物可以解決一些仍然龐大且尚未滿足的需求，我們非常密切地關注這些計劃。儘管如此，MariTide 的開發仍在快速推進，我們現在正在迅速啟動廣泛的第 3 階段計劃。我們對 MariTide 能夠為肥胖相關疾病和糖尿病患者提供的服務充滿信心。

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。我認為肥胖和肥胖相關疾病領域的數據不斷出現，並顯示出明顯的好處，即透過基於 GLP-1 的機制減輕體重確實會改善許多疾病的結果。

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.

這樣就可以繼續擴大市場並使其成長。我確實同意傑伊的觀點，即有些患者可能會尋求口服選擇。但我仍然相信，我們這裡有一個非常好的、差異化的產品，每月一次甚至更低的頻率將繼續幫助患者堅持服用減肥藥物並取得成功。希望我們在臨床試驗演示中看到一些硬終點風險降低。

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 a convenient monthly dosing.

我想說的是，我們會報告說，我們正在開發一種非常方便的一次性筆，可以方便地進行給藥。與方便的每月給藥相比，每週注射的產品可能更容易口服。

Next question, please.

請下一個問題。

Umer Raffat, Evercore ISI.

烏默·拉法特，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?

感謝您提出我的問題。如果可以的話，我想關注 MariTide。一個由兩部分組成的問題。首先，看起來你的競爭對手正在較小的資料集上進入第三階段，或者從第二階段、第三階段的角度來看，進一步推進。只是好奇為什麼您認為您肯定需要 52 週的數據？這主要是保守主義嗎？或者這也是 FDA 的一些回饋？

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?

然後在資本支出方面，我覺得 1.5 億美元的指導成長似乎相對微不足道，但它確實意味著資本支出比上半年增加了 80%。您能詳細說明一下它是與 API 相關還是您想到的其他內容嗎？

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。 Pete，我為什麼不先談談 MariTide 的整體開發計劃以及我們將在今年年底獲得的第二階段數據的價值。 Umer，如你所知，這種第一階段的藥物對肥胖症顯示出相當顯著的影響，體重指數顯著降低。事實上，在 MariTide 的 1 期研究中，僅服用 3 劑後就證明其效果相當持久，我們看到某些劑量下確實可以持續 150 天甚至更長的體重減輕。

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 confirms to regulatory requirements entering into Phase 3.

第二階段研究是一個更大的問題。這是一項 592 名患者的研究。它有 11 個臂，每月或如默多所說，甚至頻率更低的給藥。作為第二部分，我們可以真正追蹤這種耐久性訊號，並且可以精確選擇患者及其醫生真正想要的劑量。這也證實了進入第三階段的監理要求。

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，我是資本支出的 Peter，正如我們之前指出的，我們已經啟動了進一步擴大 MariTide 製造能力的活動。當然，我說過，我們現在預計 24 年的資本支出為 13 億美元，而最新的指引為 11 億至 12 億美元。

Next question, please.

請下一個問題。

Jay Olson, Oppenheimer.

傑·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 [subcu] formulation? Thank you

嘿，謝謝你提出問題。恭喜您取得的所有進展，特別是在 BiTE 平台上。您能否談談您從臨床醫生處獲得的關於IMDELLTRA 推出的任何反饋以及您可以在IMDELLTRA 中利用的BLINCYTO 的潛在經驗教訓，特別是因為您現在正在B-ALL 中推出BLINCYTO 並開發[subcu] 配方？謝謝

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

這裡把它分成幾個部分。 Murdo，您想分享我們從這次發布中學到的東西嗎？

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，傑伊。顯然，鑑於這是 5 月中旬的批准，現在還為時過早，但我不得不說，我們對思想領袖和社區腫瘤學家在市場上接受 IMDELLTRA 的方式感到非常滿意。

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.

他們的臨床信念非常高。鑑於 IMDELLTRA 的監測要求，他們正在迅速採取行動，為這些患者建立護理途徑。如你所知，這種疾病環境是一種非常困難的疾病環境。在第一線接受鉑類化療後，患者的病情進展相對較快。

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，我們顯然正在與我們的醫療團隊、客戶管理團隊和銷售組織一起快速行動，以建立快速認識並幫助學術和社區腫瘤學客戶，能夠輕鬆、安全地治療患者，並為患者提供適當的設置護理隨訪。雖然還很早，但該產品被視為這種疾病環境的重大轉變。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，傑伊。您發現了一些非常有趣的東西，那就是利用 BLINCYTO 的知識。我的意思是，這確實是我們享受雙特異性 T 細胞接合器的平台功能。

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 首次獲得批准後的開發過程中，我們看到了 BLINCYTO 課程的大量閱讀，從後期治療轉向早期治療，以提高在減少腫瘤負荷的情況下的療效。

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.

這些藥物組合起來的效用，比其他複雜的方式（例如 CAR-T）更容易獲得和評估，並將這些藥物轉移到可以產生最大影響的治療點，即前線，也是途徑以減少監測。

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.

Jay，我們正在利用 BLINCYTO 的所有經驗來推動和加速 IMDELLTRA 的開發，使其成為一線小細胞肺癌治療的組成部分，包括廣泛期和有限期疾病。正如默多所分享的，我們做這項工作確實受到了這種藥物的影響的啟發，即使在它推出的早期，學習、獲取和提供這種藥物的需求也很大。

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.

Jay，我想補充一點，當談到 xaluritamig 時，我認為你的問題也適用於此。所以請繼續關注。我們將更多地討論 xaluritamig 的數據出現，但我們對如何將 BLIN 和 IMDELLTRA 的經驗應用於此也持樂觀態度。

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 (technical difficulty) on parameters such as lipid 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?

偉大的。非常感謝您回答我的問題。我有一個問題想問傑伊。再次，在 MariTide 上。是否有任何理由認為 MariTide 可能會或可能不會在血脂或 C 反應蛋白等參數上表現出與（技術難度）不同的特徵？當您設計第三階段試驗（例如結果試驗）時，這些參數的益處有多重要？

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 listen 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。我當然可以理解這種興趣。事實上，我們正​​在進行所有這些測量以及更多測量。我們現在不會對差異化輪廓的意義進行維度化。我們非常專注於完成這項正在進行且實施良好的 MariTide 第 2 階段研究，但我們確實希望在最終我們能夠分享第 2 階段研究 A 部分的結果時了解和傾聽更多資訊。我們正在進行全面評估，以優化該藥物的劑量、時間表和影響。

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。

Great. 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.

偉大的。恭喜本季。我的問題只是關於肥胖問題。正如您和團隊所提到的，預計早期肥胖計畫之一將在今年稍後進入臨床開發。只是好奇您能否詳細說明您使用什麼鏡頭來提名第一個或下一個項目？我認為評估相當複雜，您在確定該選擇以及如何推進該選擇時擁有的任何顏色都會很棒。

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 Jay，感謝您關注其開發的早期流程。它發展得非常好。正如我們分享的，我們在開發肥胖藥物和治療肥胖相關疾病的藥物方面的策略。我們感興趣的是真正收穫腸促胰素途徑的見解，但也超越該途徑轉向其他新靶點，其中一些靶點得到遺傳推論的支持，但所有靶點都得到強大的臨床前開發包的支持。

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，這是一個多因素評估，導致決定在人類臨床研究中提供藥物資源。但這需要高度的信念，因為我們對該資源以及該領域的投資組合中的門檻不斷提高。因此，我們打算在今年下半年推進臨床研究，進一步了解這種新藥的機制和特徵。

Next question, please.

請下一個問題。

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，我想問另一個肥胖問題。就在 MariTide 上，我聽到你們現在談論了很長一段時間關於規劃廣泛的第三階段計劃。但我認為你們從來沒有談過這種情況到底何時發生，即使是籠統地說。您能否在此給出您預計開始該計劃註冊的時間範圍？

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，正如您所料，我們現在的重點是完成第二階段試驗，並儘快進入第三階段。你會意識到這是一個競爭激烈的領域。所以我們目前不會給出日期。

Next question, please.

請下一個問題。

Carter Gould, Barclays.

卡特·古爾德，巴克萊銀行。

Good afternoon. Thank you for taking the question. For Peter, on August 2, the US 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.感謝您提出問題。對 Peter 來說，8 月 2 日，美國稅務法院做出了針對可口可樂的裁決。他們的訴訟經常被認為是您所面臨的問題的最佳基準。感謝您今年早些時候接受了押金，但為什麼不應該通讀該案例？也許你可以談談你對結果的整體信心。

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，非常感謝你提出這個問題，卡特。我們對案件的評估沒有任何改變。開庭日期定於 11 月 4 日。我們對我們的儲備處於適當水平充滿信心。我想說的是，首先，我不認為——可口可樂並沒有那麼大的參考價值，我不會進行比較。

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.

我們偶爾會提到美敦力的情況。但總的來說，我們看到的是，稅務法庭在過去幾年中增強了波多黎各製造業的價值。因此，我們期待陳述我們的案例。我們對自己所處的位置非常有信心。這就是我們此時要說的。不用找了。就信心而言，我們正處於原來的位置，在過去 2.5 或 3 年裡，我們一直處於同樣的位置。

Next question, please.

請下一個問題。

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，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.

偉大的。感謝您提出問題。彼得，這裡給你另一份。我很欣賞關於資本支出的增量指導，但只是想知道考慮到 MariTide 肥胖計劃的可能範圍，您是否可以直接談論 2025 年的利潤率。

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 out 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，我們不指導長期利潤，但讓我對你今年看到的情況發表評論。我很高興談論這一點。我認為這很重要。在安進，我們致力於資本分配層次，我們先投資於創新，然後先投資內部創新。因此，考慮到這一點，特倫斯，我們一直表示，如果有機會實現強勁的稅後現金回報，我們將靈活調整利潤率，記住，對我們來說，利潤率是佔產品銷售額的百分比，而不是收入的百分比。然後我們會提前溝通。

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.

所以今年，我們在年初跟大家分享，我們覺得營業利益率大概是48%左右。我們在這一年中看到了對研發活動進行一些投資的機會，我想說，重點是發展。本季非 GAAP 研發年增 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.

現在，我們看到 24 年的非 GAAP 研發支出同比增長超過 25%，我們認為這很好，因為您已經聽說過我們擁有的深入的中後期管道，推動 MariTide 進入深中期- 和後期管道。特倫斯，無論是今年還是明年，我們始終專注於生產力和優先順序，始終尋找機會產生資本來分配創新。

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.

我們有一個名為「技術和勞動力策略」的新計劃，我們正在快速、大規模地推進該計劃。我談到了在印度海得拉巴開設一個新的人才和創新中心。因此，我們正在盡一切努力保持利潤，重新分配資本創新，並像安進一直以來那樣嚴格遵守資本支出。

Next question, please.

請下一個問題。

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.

偉大的。非常感謝。剛剛對 MariTide 以及您在 2 期糖尿病研究中的計劃有疑問。顯然，該公司對該藥物的更廣泛機會感到非常興奮，但糖尿病似乎是一個更成熟的市場，其容量限制可能比我們在肥胖症領域看到的要少。

So can you just talk a little bit about what you think you need to see to be able to compete here in dislodging compens. 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?

那麼你能簡單談談你認為你需要看到什麼才能在這裡競爭驅逐補償嗎？您能否確認該研究不需要在第三階段肥胖研究中繼續推進，或者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.

可以再把它分成兩塊。傑伊，為什麼不先解決第一個問題，然後默多就可以隨意加入了。

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.

是的，一點沒錯。正如您在今年稍後明確指出的那樣，我們將啟動一項額外的專門 2 期研究，該研究將描述 MariTide 對肥胖和非肥胖患者的糖尿病治療的特徵。這項新研究根本不是針對肥胖患者的第三階段計畫的門控步驟。

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?

但符合監管指導，重要的是，使我們能夠優化糖尿病患者的劑量，在醫學上，我可以說你的相當大的觀點，我不知道有一種非常有效的每月或不頻繁服用的藥物來治療糖尿病。默多？

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。我同意您的觀點，即我們所討論的長期體重管理的差異化在 2 型糖尿病中將發揮強有力的作用。雖然有許多產品可以控制高血糖並提供 [HbA1c] 控制，但如果您能夠提高依從性和持久性，則會帶來顯著的好處。我們確實相信我們每個月的劑量可以做到這一點。

Next question, please Julianne?

下一個問題，請朱麗安？

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 glip. 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。另一個肥胖問題，但有點離題。我不確定你之前是否討論過這個問題，但有過一次關於透過 glip 減肥的人如何保存肌肉的討論。您是否透過 MariTide 評估了這方面的情況？您認為這是該領域廣泛存在的問題嗎？如果是這樣，您認為 MariTide 適合這種情況嗎？

Thank you.

謝謝。

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

當然。傑伊，你為什麼不跳進去呢？

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。謝謝你的問題。我們——正如您顯然所做的那樣，正在服用這類藥物，這些藥物會引起顯著的體重減輕或對健康組織（包括但不限於肌肉）的影響，並且文獻中報告的相關肌肉損失可能從機制上講，也可能與接受這些藥物治療的患者體重減輕的驚人節奏有關。當時間成熟時，我們和其他人將會得到這個答案。

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.

正如您可以想像的那樣，我們正在自己的研究中進行許多此類測量，並且今天沒有任何報告任何數據可以向您報告，但我們也在關注這一點。一些組織正在尋求透過肥胖藥物來支持肌肉損失，鑑於我們的肌肉生物學遺產，這對我們來說非常有趣。但我想說，這些都是來自該領域的早期見解。據我所知，尚未證明它們會使患者虛弱，但我們希望您感興趣。

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

茱麗安說我們已經到了前半小時了。也許我們再問兩個問題。

James Shin, Deutsche Bank.

詹姆斯‧辛，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 there's no next obesity asset will work in tandem with 133?

嗨，大家好。感謝您提出我的問題。今年稍後進入診所的下一個肥胖資產，您能否具體說明該資產是否旨在填補 [786]，以及是否沒有下一個肥胖資產可以與 133 協同工作？

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 increasing pathway.

謝謝，詹姆斯。今天我們不會提供有關這種藥物的任何進一步的見解。還太早了。正如鮑勃分享的那樣，這對患者來說非常好，是一個競爭非常激烈的空間。但正如我之前分享的，在我們更深層的肥胖研究中，我們仍然對增加的途徑感興趣。

We remain interested 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。我們也在開發口服藥物。因此，在時間充裕時，我們將有機會分享更多內容。我們確實在打一場持久戰，為患者帶來真正的差異化利益，並進入即使是當前藥物也無法很好解決的市場領域。

Gary Nachman, Raymond James.

加里·納赫曼，雷蒙德·詹姆斯。

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。所以轉向 TEPEZZA。您認為我們什麼時候會看到低 CAS 患者的加速成長？這些患者的報銷情況如何改善？並描述日本的機會明年能帶來多大幫助？

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 和其他罕見疾病投資組合背後投入的整體資源，顯然，這對您來說是一個更大的關注點，如果這種資源繼續以何種速度增加，以及何時您可以獲得更多的營運槓桿來自罕見疾病業務？

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.

加里，有很多問題，但我們為什麼不把它分成幾個部分呢？繼續吧，維克拉姆。

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，加里。看，我們對今年 TEPEZZA 的執行情況並推動其成長感到非常滿意。正如您所觀察到的，有大量患有這種疾病的低 CAS 患者或低臨床活動評分患者沒有得到適當的治療。具體來說，這大約是美國 10 萬名可尋址患者中的 8 萬名。

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.

我們一直在做的事情是看到擴大我們的處方者基礎的巨大勢頭，現在除了眼整形外科醫生之外，還包括眼科醫生和內分泌科醫生。這是一個非常重要的元素。內分泌科的策略重點非常重要，這樣我們才能更好地服務那些低 CAS 患者，低 CAS 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.

您詢問了有關改善訪問的問題。迄今為止，我們已經為超過 65% 的美國受保人實現了有利的醫療政策變革。如果將這一數字與上季度的 50% 和大約一年前的 5% 進行比較，我認為我們在使用去年提供的第四階段數據來實現患者訪問方面取得了相當大的進展。

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 在美國的重大成長機會，同時也認識到，隨著我們透過大量執行努力取得進展，在我們消除准入障礙、擴大我們的處方者基礎之間仍然存在時間滯後並觀察患者接受治療。

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，我們預計在日本，他們將再次成為一個有吸引力的市場，並且這將在該國受到好評，一旦我們在明年推出該產品，我們將討論這一點。關於槓桿作用，我想我只想說我們已經步入正軌。就我們在那裡的協同目標而言，我們將開始獲得更多的影響力，因為我們能夠完全控制罕見疾病產品的供應鏈。

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.

然後我會進一步觀察，正如我們多次說過的那樣，幸運的是我們現有的一些銷售和行銷能力與這些罕見疾病產品的需求之間存在很好的重疊。總而言之，我們仍然對我們能夠為罕見疾病患者做的事情、我們所擁有的地位以及隨著時間的推移而改善的可能性感到非常興奮。因此，讓我感謝你們所有人。我知道我們已經超出了規定的時間幾分鐘，但感謝大家參與電話會議，我們期待在第三節後與你們重新組合。謝謝。