美國安進 (AMGN) 2023 Q2 法說會逐字稿

My name is Julianne, and I will be your conference facilitator today for Amgen's Second Quarter 2023 Financial Results Conference Call. (Operator Instructions)

我是朱莉安娜，今天我將擔任安進公司2023年第二季財務業績電話會議的主持人。 （操作說明）

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

現在我謹介紹投資人關係副總裁阿文德‧蘇德先生。蘇德先生，您可以開始了。

Thank you, Julianne. Good afternoon, everyone, and welcome to our call to discuss our results for the second quarter. We continued down the path of strong unit volume growth during the quarter that led to an improved outlook for the rest of the year. This also sets the stage for growth longer term augmented by some meaningful pipeline updates, particularly with an oncology development.

謝謝朱莉安。大家下午好，歡迎參加我們關於第二季業績的電話會議。本季我們持續保持強勁的銷售成長勢頭，這使得我們對今年剩餘時間的業績展望更加樂觀。這也為長期成長奠定了基礎，一些重要的產品線更新，特別是腫瘤治療領域的研發進展，將進一步推動成長。

Our Chairman and CEO, Bob Bradway, will lead the call with some prepared remarks, followed by a broader review of our performance by other members of our leadership team. You should have received a link to our slides that we posted. Through the course of our discussion, we will make some forward-looking statements and use non-GAAP financial measures to describe our performance. And just a reminder that actual results can vary materially.

我們的董事長兼執行長鮑勃·布拉德韋將首先發表一些準備好的講話，隨後由我們領導團隊的其他成員對公司業績進行更全面的回顧。您應該已經收到我們發布的幻燈片連結。在討論過程中，我們將做出一些前瞻性陳述，並使用非GAAP財務指標來描述我們的績效。再次提醒您，實際結果可能與預期有重大差異。

So with that, I would like to turn the call over to Bob. Bob?

那麼，接下來我想把電話交給鮑伯。鮑伯？

Okay. Thank you for joining our call. It was an excellent quarter across the board for Amgen and one that demonstrates why we remain very confident about our ability to deliver attractive long-term growth in sales and earnings. We delivered $7 billion in quarterly revenue, up 6% from a year ago, along with record non-GAAP earnings per share of $5 a share, up 8% over the prior year. Volume growth globally was 11% in the quarter, and that reflects all 3 of our therapeutic areas and all 3 of our geographic regions contributing to performance.

好的。感謝各位參加我們的電話會議。安進本季整體業績表現出色，充分展現了我們對實現銷售額和獲利長期成長的信心。本季營收達70億美元，較去年成長6%；非GAAP每股盈餘創歷史新高，達5美元，較去年成長8%。全球銷售本季成長11%，這得益於我們三大治療領域和三大地理區域的共同貢獻。

For example, volume in our General Medicine business grew by 21% in the quarter, while volume in our Asia Pacific region, which we have previously identified as a key source of growth for us, was up 46%. A time of product shortages in the industry, our world-class manufacturing capabilities have enabled us to meet growing demand for our products and continue our long-standing tradition of serving every patient every time.

例如，本季我們一般藥品業務的銷售成長了21%，而我們先前已確定為關鍵成長來源的亞太地區銷售成長了46%。在行業產品短缺的時期，我們世界一流的生產能力使我們能夠滿足不斷增長的產品需求，並延續我們長期以來為每位患者提供始終如一優質服務的傳統。

Nine of our medicines generated record sales in the quarter. This is consistent with my comments from our first quarter call in April, when I said we see the potential for many of our currently marketed products to reach significantly more patients over time and to contribute substantially to our long-term growth.

本季度，我們九種藥品的銷售額均創下歷史新高。這與我在四月第一季財報電話會議上的表態一致，當時我曾表示，我們認為目前市面上許多產品都有潛力在未來惠及更多患者，並為我們的長期成長做出重大貢獻。

In April, I spoke about Repatha and the growing contribution it's making in the fight against cardiovascular disease. Today, I'll highlight Prolia which achieved $1 billion in quarterly sales for the first time, up 11%. Prolia is one of the first biologics to be widely prescribed by primary care physicians to treat a chronic disease, something we expect to see replicated over time in other categories like cardiovascular disease.

今年四月，我曾談到瑞百安（Repatha）及其在對抗心血管疾病方面日益增長的貢獻。今天，我想重點介紹普羅利亞（Prolia），該藥季度銷售額首次突破10億美元大關，年增11%。普羅利亞是第一批被基層醫師廣泛用於治療慢性疾病的生物製劑之一，我們預期未來在其他疾病領域，例如心血管疾病領域，也會出現類似的應用。

For all of Prolia's success, though, we know that osteoporosis remains an underdiagnosed and undertreated disease, placing millions of elderly women at risk for life-changing fractures. With recently generated real-world data, we've established that Prolia is superior to alendronate, the most frequently prescribed bisphosphonate treatment in the U.S. in reducing fractures and not by a little, but by a lot.

儘管Prolia取得了許多成功，但我們知道骨質疏鬆症仍然是一種診斷不足且治療不足的疾病，使數百萬老年女性面臨發生可能改變人生的骨折的風險。根據近期獲得的真實世界數據，我們證實Prolia在降低骨折風險方面優於阿崙膦酸鈉（美國最常用的雙磷酸鹽類藥物），且優勢顯著。

To give you one data point. In May, we announced that in a real-world study, Prolia reduced the risk of hip fracture by 36%, compared to alendronate, that superior. Prolia and EVENITY, which achieved 47% sales growth in the quarter, give us a powerful 1-2 punch against osteoporosis. A disease that will only become more prevalent as the world grows older. You'll hear more from Murdo shortly about our very strong commercial performance through the first half of 2023.

舉個例子。今年五月，我們宣布了一項真實世界研究，結果顯示，與療效較佳的阿崙膦酸鈉相比，Prolia 可將髖部骨折風險降低 36%。 Prolia 和 EVENITY（本季銷售額成長 47%）強強聯合，為我們對抗骨質疏鬆症提供了強而有力的「組合拳」。隨著世界人口老化，骨質疏鬆症的盛行率只會越來越高。不久之後，Murdo 將詳細介紹我們在 2023 年上半年的強勁商業表現。

We're seeing strong momentum in our pipeline, too. As you'll hear in detail from Dave Reese, we're sharing positive data today for our BiTE tarlatamab, in small cell lung cancer and for LUMAKRAS in combination with Vectibix in colorectal cancer. We are especially excited about the tarlatamab readout. Not only because of what it may mean for patients whose prognosis is otherwise exceptionally poor, but also because it adds to our growing conviction that bispecific T-cell engagers are an effective way to treat solid tumors as well as liquid tumors as we have demonstrated with BLINCYTO.

我們的研發管線也發展勢頭強勁。正如Dave Reese將詳細介紹的那樣，我們今天將分享BiTE tarlatamab在小細胞肺癌治療中的積極數據，以及LUMAKRAS聯合Vectibix治療結直腸癌的積極數據。我們尤其對tarlatamab的試驗結果感到振奮。這不僅是因為它對預後極差的患者意義重大，也因為它進一步鞏固了我們日益增長的信念：雙特異性T細胞銜接器是治療實體瘤和血液腫瘤的有效方法，正如我們之前在BLINCYTO上所證明的那樣。

Elsewhere in our pipeline, we continue to advance registration-enabling trials for several potential new first-in-class medicines, including olpasiran in heart disease, rocatinlimab in atopic dermatitis and of course, bemarituzumab in gastric cancer. We look forward to additional readouts from our pipeline in the second half of the year.

在其他研發管線中，我們正持續推進幾項潛在的首創新藥的註冊審批臨床試驗，包括用於治療心臟病的olpasiran、用於治療異位性皮膚炎的rocatinlimab，以及用於治療胃癌的bemarituzumab。我們期待在今年下半年獲得更多這些研發管線的試驗結果。

Turning to our planned acquisition of Horizon Therapeutics. We remain very enthusiastic about what our companies can achieve together for patients suffering from rare serious diseases. Horizon has certainly accomplished a great deal as an independent company. Amgen's global commercial, manufacturing and R&D capabilities, especially for biologic products, will enable Horizon's medicines to reach even more patients more quickly than Horizon could have achieved on its own. As you know, this combination has been approved by regulators around the world with the exception of the Federal Trade Commission in the United States. The FTC's arguments in this case are based on speculation and hypothetical notions. Their arguments are not grounded in long-established antitrust law.

關於我們計劃收購Horizo​​​​n Therapeutics的事宜，我們仍然對兩​​家公司攜手為患有罕見重症的患者所取得的成就充滿信心。 Horizo​​n作為一家獨立公司，無疑已取得了巨大的成就。安進的全球商業化、生產製造和研發能力，尤其是在生物製品領域，將使Horizo​​​​n的藥物能夠比Horizo​​​​n單打獨鬥更快地惠及更多患者。如您所知，除美國聯邦貿易委員會（FTC）外，此次合併已獲得全球監管機構的批准。 FTC在此案中的論點是基於推測和假設，缺乏長期確立的反壟斷法依據。

Notwithstanding that and choosing to pursue this case, they've ignored the commitments we made to address their stated concerns. Life-changing medicines that Amgen and Horizon offer, treat different diseases and different patient populations. Simply put, there are no competitive overlaps and no incentives to bundle our drugs with theirs. We look forward to making our case in court in September and I'm confident rather that we will prevail.

儘管如此，他們仍然選擇提起訴訟，卻無視了我們為解決他們所提出的擔憂所做的承諾。安進和地平線公司提供的改變生命的藥物治療的是不同的疾病，針對的是不同的患者群體。簡而言之，不存在競爭重疊，他們也沒有動機將我們的藥物與他們的藥物捆綁銷售。我們期待在九月的法庭上陳述我們的理由，而且我堅信我們會勝訴。

In the meantime, we're working closely on integration plans with Horizon, so we can hit the ground running by mid-December, which is when we anticipate being able to close the deal. And let me just reiterate one more point before I hand over to Murdo. As the second quarter illustrates, Amgen's business is performing very well and our organic outlook for growth is strong. Adding Horizon will serve to enhance our growth prospects even further. And let me close by thanking my Amgen colleagues around the world for their unwavering commitment to patients and to our business. We're excited about the future and our ability to serve many, many more patients than we do today. Murdo?

同時，我們正與Horizo​​​​n緊密合作制定整合計劃，以便在12月中旬之前迅速啟動整合工作，屆時我們預計能夠完成交易。在將發言權交給Murdo之前，我還要重申一點。正如第二季業績所示，安進的業務表現非常出色，我們的內生成長前景強勁。收購Horizo​​​​n將進一步提升我們的成長潛力。最後，我要感謝安進全球的同事們，感謝他們對病人和公司業務的堅定承諾。我們對未來充滿信心，並期待能夠服務比現在多得多的患者。 Murdo？

Thanks, Bob. I'm very pleased with our performance in the second quarter, fueled by a commitment to deliver on our mission to bring innovative products to millions of patients globally. Execution is strong across the business with record quarterly sales for 9 brands and robust volume growth across our General Medicine, Inflammation and Hematology/Oncology portfolios.

謝謝，鮑伯。我對我們第二季的業績非常滿意，這得益於我們始終致力於實現為全球數百萬名患者帶來創新產品的使命。公司各業務部門的執行力都很強勁，9 個品牌的季度銷售額均創歷史新高，普通內科、發炎和血液/腫瘤產品組合的銷量也實現了穩健增長。

Excluding the impact of foreign exchange, second quarter global product sales grew 8% year-over-year, including the impact of foreign exchange, product sales increased 6% year-over-year. Volume growth was 11% with strength across our regions. U.S. volume growth was 9% and volume growth in our Europe, Latin America, Middle East and Canada region was 8%. And consistent with our international expansion strategy, Asia Pacific continues to be our fastest-growing region with 46% volume growth in the quarter.

剔除匯率影響，第二季全球產品銷售額年增8%；計入匯率影響，產品銷售額年增6%。銷量成長11%，各區域均表現強勁。美國銷量成長9%，歐洲、拉丁美洲、中東和加拿大地區銷量成長8%。亞太地區持續維持成長最快，本季銷售成長46%，這與我們的國際擴張策略相符。

Starting with our General Medicines business, which includes Repatha, Prolia, EVENITY and Aimovig. Overall revenue for these 4 products grew 19% year-over-year in the second quarter, driven by 21% volume growth. Cardiovascular disease is a growing public health crisis and the state of care for high-risk ASCVD patients with elevated LDL-cholesterol is poor. A family heart real-world analysis of 38 million high risk Americans, revealed that fewer than 30% of them ever reach their recommended LDL levels. This is a clear call to action that lowering LDL cholesterol as much and as early as possible with Repatha will reduce cardiovascular risk for patients.

首先來看我們的普通藥品業務，其中包括瑞百安 (Repatha)、普羅利亞 (Prolia)、依維寧 (EVENITY) 和艾莫維 (Aimovig)。這四款產品的總營收在第二季年增 19%，主要得益於銷售量成長 21%。心血管疾病日益成為公共衛生危機，而高風險動脈粥狀硬化性心血管疾病 (ASCVD) 患者（尤其是低密度脂蛋白膽固醇 (LDL-C) 升高的患者）的治療現狀令人擔憂。一項針對 3,800 萬高風險美國人的家庭心臟真實世界分析顯示，其中只有不到 30% 的人能夠達到建議的 LDL-C 水平。這明確表明，儘早使用瑞百安降低 LDL-C 水平將有助於降低患者的心血管風險。

And so to meet this need, Amgen is committed to improving patients' ease of access and affordability. Today, we have best-in-class formulary coverage for Repatha helping 90% of eligible U.S. patients gain access to this important medicine. Improved access is enabling broad adoption of Repatha by cardiologists and increasing adoption by primary care providers. So this has set the stage for growth for Repatha sales, which increased 30% year-over-year to a record $424 million in the second quarter.

為了滿足這項需求，安進致力於提升患者取得藥物的便利性和可負擔性。如今，我們已將瑞百安納入一流的藥品目錄，幫助90%符合資格的美國患者獲得這種重要的藥物。更方便的用藥途徑促進了瑞百安在心臟科醫師中的廣泛應用，並提高了初級保健醫師的使用率。這為瑞百安的銷售成長奠定了基礎，其銷售額在第二季度年增30%，創下4.24億美元的紀錄。

In the U.S., volume growth of 34% was driven by a record number of new patients starting treatment. Outside the U.S., we saw 37% volume growth with momentum across our regions. We recognize there are still many more patients around the world who can benefit from Repatha. And to meet that challenge, we are increasing investment to intensify our engagement with health care providers, bring our message directly to patients through direct-to-consumer media and drive urgency around LDL-C testing and adherence to treatment guidelines.

在美國，銷售量成長34%，主要得益於新患者人數創歷史新高。在美國以外，銷售成長37%，各地區均維持強勁成長動能。我們意識到，全球仍有大量患者能夠從瑞百安（Repatha）中獲益。為了應對這項挑戰，我們將加大投入，加強與醫療服務提供者的合作，透過面向消費者的媒體管道直接向患者傳遞訊息，並提高人們對低密度脂蛋白膽固醇（LDL-C）檢測和治療指南依從性的重視程度。

Transitioning to bone health. Prolia sales grew 11% year-over-year to a record $1 billion in the second quarter, driven by 11% volume growth. As Dave will discuss in more detail, new real-world evidence data presented at the World Congress on Osteoporosis in May demonstrates that Prolia significantly reduces fracture risk across multiple endpoints when compared to alendronate. Our sales teams are now equipped with these data and are actively helping physicians understand the superior ability of Prolia to reduce the risk of fracture for their osteoporosis patients.

轉向骨骼健康領域。第二季度，Prolia 的銷售額年增 11%，創下 10 億美元的新紀錄，這主要得益於銷量成長 11%。正如 Dave 將要詳細闡述的，5 月在世界骨質疏鬆症大會上公佈的最新真實世界證據數據顯示，與阿崙膦酸鈉相比，Prolia 在多個終點指標上均能顯著降低骨折風險。我們的銷售團隊目前已掌握這些數據，並積極幫助醫生了解 Prolia 在降低骨質疏鬆症患者骨折風險方面的卓越功效。

EVENITY, which complements Prolia in our Bone portfolio had record sales of $281 million for the quarter, driven by strong volume growth across markets. In Japan, EVENITY has achieved a 42% share of the growing [bone builder] market steadily increasing performance versus competitors and increasing initiation for naive patients. EVENITY sales are now annualizing at over $1 billion. And given the severe impact of fractures on the lives of women who are postmenopausal our success in Japan, the first launch market for EVENITY enhances our confidence in the significant growth potential through this decade.

作為我們骨骼產品組合中Prolia的補充，EVENITY本季銷售額創下2.81億美元的新紀錄，這主要得益於各市場強勁的銷售成長。在日本，EVENITY已佔據不斷增長的骨骼構建劑市場42%的份額，其性能持續優於競爭對手，並吸引了更多初次使用該產品的患者。 EVENITY的年銷售額目前已超過10億美元。鑑於骨折對停經後女性生活造成的嚴重影響，EVENITY在日本這個個上市市場的成功，增強了我們對未來十年巨大成長潛力的信心。

Otezla sales increased 1% year-over-year, driven by 2% volume growth. 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 naive U.S. patients with milder psoriasis that cannot be optimally addressed by a topical treatment and can benefit from a systemic drug like Otezla.

受2%的銷售成長推動，Otezla的銷售額較去年同期成長1%。 Otezla仍然是唯一獲準的適應症廣泛的口服全身性治療藥物，有望幫助超過150萬美國初治輕度乾癬患者。這些患者無法透過局部治療獲得最佳療效，但可以從Otezla等全身性藥物中獲益。

Our U.S. Otezla business has been impacted by free drug programs for newly launched topical and systemic competitors, and we expect new patient demand will continue to be affected by these programs for the remainder of 2023. Despite this, we see a compelling opportunity to invest in growth of Otezla and to drive increased awareness amongst physicians and patients. We're confident in the growth potential of Otezla given its unique combination of established efficacy and safety profile, broad payer coverage with limited prior authorization requirements and a lack of testing required for initiation and of course, ease of administration.

我們的美國Otezla業務受到了新上市的局部用藥和全身用藥競爭對手的免費藥物計劃的影響，我們預計這些計劃在2023年剩餘時間內將繼續影響新患者的需求。儘管如此，我們仍然看到了投資Otezla成長並提高醫生和患者對其認知度的巨大機會。我們對Otezla的成長潛力充滿信心，因為它兼具已確立的療效和安全性、廣泛的醫保覆蓋範圍（事先授權要求有限）、無需進行任何檢測即可開始使用，而且給藥方便。

Enbrel sales grew 84% quarter over quarter following the seasonal impact on price and a large drawdown of inventory during the first quarter in the U.S. Year-over-year, Enbrel sales increased 2%, driven by favorable changes to estimated sales deductions and higher net selling price, partially offset by lower inventory levels. Although year-over-year volume was flat in the second quarter, the number of new patients in the U.S. starting treatment increased by 6%, driven by improved payer coverage. For the remainder of 2023, we expect this improved coverage will lead to continued growth in new patients. We also expect declining net selling price on a full year basis.

受季節性價格波動和美國第一季庫存大幅下降的影響，恩利（Enbrel）銷售額環比成長84%。年比來看，恩利銷售額成長2%，主要得益於預估銷售扣減的有利變化和淨售價的提高，但部分被較低的庫存水準所抵銷。儘管第二季銷售量與去年同期持平，但由於健保覆蓋範圍的擴大，美國新開始接受治療的患者人數增加了6%。我們預計，在2023年剩餘時間內，醫保覆蓋範圍的擴大將推動新病患人數的持續成長。同時，我們也預計全年淨售價將有所下降。

TEZSPIRE continues to show robust growth with $133 million of sales in the second quarter. Sales increased 39% sequentially driven by 37% volume growth that benefited from the introduction of our self-administered, prefilled, single-use pen approved by the U.S. Food and Drug Administration in the first quarter. The pen offers patients a convenient option to administer TEZSPIRE at home, which improves accessibility and provides more flexibility in treatment options for all patients in the U.S. with severe uncontrolled asthma.

TEZSPIRE 持續保持強勁成長勢頭，第二季銷售額達 1.33 億美元。銷售額環比成長 39%，主要得益於銷售量成長 37%，而銷售成長則得益於我們於第一季推出的預填充式單次注射筆，該注射筆已獲得美國食品藥物管理局 (FDA) 的批准。這款注射筆為患者提供了一種便捷的居家注射 TEZSPIRE 的選擇，提高了治療的可及性，並為美國所有患有嚴重未控制氣喘的患者提供了更靈活的治療方案。

Sales of TAVNEOS were $30 million in the second quarter. U.S. volumes grew 28% quarter-over-quarter, driven by an increase in new patients starting treatment. In the U.S., approximately 2,000 patients have now been treated with TAVNEOS by over 1,300 healthcare providers. Looking forward, Amgen's deep experience in inflammation and nephrology and substantial market presence will allow us to bring TAVNEOS to even more patients with ANCA-associated vasculitis.

第二季TAVNEOS的銷售額為3000萬美元。美國市場銷售量較上季成長28%，主要得益於新患者數量的增加。目前，美國已有超過1,300家醫療機構為約2,000名患者使用TAVNEOS進行治療。展望未來，安進在發炎和腎臟病領域的深厚經驗以及強大的市場影響力將使我們能夠為更多ANCA相關性血管炎患者提供TAVNEOS治療。

AMJEVITA sales increased 29% year-over-year for the second quarter, driven by 60% volume growth, partially offset by lower inventory levels and net selling price. U.S. sales decreased 63% sequentially driven by inventory drawdowns after stocking to support the launch in the first quarter, partially offset by volume growth.

AMJEVITA第二季銷售額年增29%，主要得益於銷售量成長60%，但部分被庫存水準和淨售價的下降所抵銷。美國市場銷售額較上季下降63%，主要原因是第一季為支持產品上市而進行的庫存積壓導致庫存減少，但部分被銷售成長所抵銷。

Moving to our Hematology/Oncology business, which includes LUMAKRAS, KYPROLIS, XGEVA, Vectibix, Nplate and BLINCYTO. Strong commercial execution and exciting new clinical data drove 12% volume growth year-over-year for these 6 innovative products. BLINCYTO sales grew 48% year-over-year with adoption across academic community and pediatric centers following positive data from the registration-enabling E1910 study presented in December of 2022, and updated NCCN guidelines that were issued in May, both the positive data and the updated guidelines support our confidence in the continued growth potential for BLINCYTO.

接下來是我們的血液/腫瘤業務，其中包括LUMAKRAS、KYPROLIS、XGEVA、Vectibix、Nplate和BLINCYTO。強勁的商業執行力和令人振奮的全新臨床數據推動這六款創新產品銷售量年增12%。 BLINCYTO的銷售額年增48%，這得益於學術機構和兒科中心的廣泛採用。先前，2022年12月公佈的註冊支持性E1910研究的積極數據，以及5月份發布的NCCN指南更新，都增強了我們對BLINCYTO持續增長潛力的信心。

Vectibix sales increased 20% year-over-year for the second quarter, driven by 20% volume growth supported by promotion of positive data from the Phase III PARADIGM trial, demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy for patients with wild-type [RAS] colorectal cancer.

第二季 Vectibix 銷售額年增 20%，這主要得益於銷量成長 20%，而銷量成長又得益於 III 期 PARADIGM 試驗的積極數據推廣，該試驗表明，對於野生型 [RAS] 結直腸癌患者，Vectibix 與貝伐珠單抗聯合化療具有優勢。

KYPROLIS grew 9% year-over-year, driven by 15% volume growth, partially offset by lower net selling price. And LUMAKRAS reported $77 million of sales for the second quarter, year-over-year sales were flat in the quarter as 20% volume growth was offset by lower net selling price and inventory levels. We see future growth opportunity for LUMAKRAS driven by launches in new markets and our comprehensive global clinical development program.

KYPROLIS 年成長 9%，主要得益於 15% 的銷售成長，但部分被較低的淨售價所抵銷。 LUMAKRAS 第二季度銷售額為 7,700 萬美元，與去年同期持平，原因是 20% 的銷售成長被較低的淨售價和庫存水準所抵銷。我們認為，LUMAKRAS 未來在開拓新市場和我們全面的全球臨床開發計畫的推動下，擁有巨大的成長潛力。

Our execution is strong across the business, driving growth and exemplifying our dedication to serving patients. Our business is performing at a very high level and with the announced acquisition of Horizon Therapeutics, we have the potential to serve many more patients who can benefit from our decades of leadership in inflammation and nephrology.

我們在整個業務領域都展現出強大的執行力，推動了業務成長，並體現了我們致力於服務患者的決心。我們的業務表現非常出色，隨著對 Horizo​​n Therapeutics 的收購，我們有望為更多患者提供服務，讓他們受益於我們在發炎和腎臟病領域數十年的領先地位。

With that, I'll turn it over to Dave Reese.

接下來，我將把麥克風交給戴夫‧里斯。

Thanks, Murdo. Good afternoon, everyone. For R&D, the second quarter was one of high-quality execution as we progressed our innovative pipeline with 2 important data readouts, multiple registration-enabling studies on track and additional exciting data coming later this year.

謝謝，默多。大家下午好。研發方面，第二季執行力強勁，我們推進了創新產品線，獲得了兩項重要數據，多項註冊研究正在按計劃進行，更多令人振奮的數據將於今年稍後公佈。

Beginning with oncology, we are exceptionally pleased to announce positive top line results from the global Phase II DeLLphi-301 trial evaluating tarlatamab, a first-in-class DLL3 targeting BiTE molecule in patients with relapsed or refractory small cell lung cancer that progressed after 2 or more prior lines of treatment.

首先是腫瘤學方面，我們非常高興地宣布，評估 tarlatamab（一種首創的 DLL3 靶向 BiTE 分子）治療復發或難治性小細胞肺癌（在接受過 2 線或以上先前治療後進展）患者的全球 II 期 DeLLphi-301 試驗取得了積極的初步結果。

Tarlatamab demonstrated an objective response rate, the primary endpoint, that substantially exceeds what was previously reported in the Phase I study. Responses were durable and longer than what is expected with standard of care chemotherapy. Safety and tolerability were also more favorable compared to the Phase I study. This is the first time that a BiTE specific T-cell engager has shown unequivocal activity in a common solid tumor, a real milestone in the field.

Tarlatamab 的主要終點——客觀緩解率——顯著高於先前 I 期研究的報導。緩解持續時間長，且優於標準化療的預期療效。與 I 期研究相比，安全性和耐受性也較佳。這是第一個 BiTE 特異性 T 細胞銜接器在常見實體腫瘤中展現出明確療效的案例，是該領域的一個真正里程碑。

We look forward to discussing these data soon with the FDA and other regulatory agencies and presenting detailed results of this potentially registrational Phase II study at an upcoming medical congress. Based on the data we have observed, we are moving tarlatamab into earlier lines of therapy with DeLLphi-304, a Phase III study underway comparing tarlatamab with standard of care chemotherapy in second-line small cell lung cancer. We are also planning to initiate 2 additional Phase III studies of tarlatamab in earlier [lines] of small cell lung cancer. From my personal point as oncologist, I believe this molecule can be transformative and can't wait to share these data with the field.

我們期待盡快與FDA及其他監管機構討論這些數據，並在即將召開的醫學大會上公佈這項可能具有註冊意義的II期研究的詳細結果。基於我們觀察到的數據，我們正在推進tarlatamab在早期治療中的應用，目前正在進行一項名為DeLLphi-304的III期研究，該研究旨在比較tarlatamab與標準化療方案在二線小細胞肺癌治療中的療效。我們也計劃啟動另外兩項tarlatamab在早期小細胞肺癌治療的III期研究。身為腫瘤科醫生，我個人認為這種分子具有變革性意義，並且迫不及待地想與業界分享這些數據。

Turning to LUMAKRAS. We continue to execute on our comprehensive clinical program designed to generate the breadth of data necessary to understand KRAS biology and the role LUMAKRAS can play in non-small cell lung cancer, colorectal cancer and other solid tumors. We are delighted to announce that the global Phase III CodeBreaK 300 trial evaluating LUMAKRAS combined with Vectibix in chemorefractory metastatic KRAS G12C mutated colorectal cancer met its primary endpoint of progression-free survival for both the 240-milligram and 960-milligram doses. At comparable doses, efficacy results were consistent with what was previously observed in this setting with no new safety signals. We look forward to sharing these results with global health authorities and presenting the detailed results at an upcoming medical congress. The FDA recently granted breakthrough therapy designation for LUMAKRAS in combination with Vectibix for the treatment of patients with metastatic KRAS G12C mutated colorectal cancer as determined by an FDA-approved test, who have received prior chemotherapy based on data from the prior CodeBreaK 101 study.

接下來談談LUMAKRAS。我們正持續推動全面的臨床項目，旨在收集必要的廣泛數據，以深入了解KRAS生物學以及LUMAKRAS在非小細胞肺癌、結直腸癌和其他實體腫瘤中的作用。我們欣喜地宣布，評估LUMAKRAS合併Vectibix治療化療難治性轉移性KRAS G12C突變結直腸癌的全球III期臨床試驗CodeBreaK 300已達到其主要終點，即240毫克和960毫克劑量組的無進展生存期。在劑量相當的情況下，療效結果與先前在該適應症中觀察到的結果一致，且未發現新的安全性訊號。我們期待與全球衛生監管機構分享這些結果，並在即將舉行的醫學大會上公佈詳細結果。根據先前 CodeBreaK 101 研究的數據，FDA 最近授予 LUMAKRAS 與 Vectibix 聯合治療轉移性 KRAS G12C 突變結直腸癌患者的突破性療法認定，用於治療經 FDA 批准的檢測確定的、之前接受過化療的患者。

Beyond these data, we continue to explore novel combinations as we seek to move LUMAKRAS into the first-line setting. Recently presented data from the SCARLET study provide the rationale to initiate a Phase III trial of LUMAKRAS combined with chemotherapy in first-line non-small cell lung cancer patients with PD-L1 negative tumors and Phase Ib data in combination with Vectibix and chemotherapy support the initiation of a Phase III study of LUMAKRAS with Vectibix and FOLFIRI in first-line G12C-mutated colorectal cancer.

除了這些數據之外，我們仍在探索新的聯合療法，力求將LUMAKRAS推進至第一線治療。近期發表的SCARLET研究數據為啟動LUMAKRAS聯合化療一線治療PD-L1陰性非小細胞肺癌患者的III期臨床試驗提供了理論基礎；而LUMAKRAS聯合Vectibix和化療的Ib期臨床試驗數據也支持啟動LUMAKRAS聯合直腸試驗患者的臨床結直腸癌。

In June, the FDA approved the supplemental Biologics License Application for BLINCYTO for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease greater than or equal to 0.1%. The approval converts BLINCYTO's accelerated approval to a full approval.

今年6月，FDA批准了BLINCYTO的補充生物製品許可申請，​​用於治療CD19陽性B細胞前驅急性淋巴性白血病成人和兒童患者，這些患者處於首次或第二次完全緩解期，且微小殘留病灶≥0.1%。此次批准將BLINCYTO的加速批准轉為完全批准。

Global regulatory submissions are on track for E1910, a Phase III trial conducted by the National Cancer Institute, Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network Cancer Research Group that demonstrated superior overall survival with BLINCYTO treatment added to consolidation chemotherapy over standard of care consolidation chemotherapy in newly diagnosed adult patients with Philadelphia negative-ALL who are MRD-negative following induction and intensification chemotherapy.

E1910 的全球監管申報工作正在按計劃進行。 E1910 是一項 III 期試驗，由美國國家癌症研究所、東部腫瘤協作組和美國放射學會影像網絡癌症研究組開展，結果表明，對於新診斷的費城染色體陰性急性淋巴細胞白血病 (Philadelphia-ALL) 成年患者，在誘導和強化化療後 MRD 陰性，與標準治療鞏固化療相比，在鞏固化療的基礎上增加 BCYLINTO 治療後 MRD 陰性，與標準治療鞏固化療相比，在鞏固化療的基礎上增加 BCYLINTO 治療後顯著生存總期。

Three important updates were made to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology in B-cell ALL. These included listing the BLINCYTO E1910 regimen as the only preferred regimen for the first-line treatment of Philadelphia negative adult patients, adding BLINCYTO to multi-agent chemotherapy as consolidation in MRD-negative disease. And lastly, moving BLINCYTO in combination with the tyrosine kinase inhibitor to the top of the treatment algorithm for MRD-negative Philadelphia-positive disease.

美國國家綜合癌症網絡（NCCN）B細胞急性淋巴細胞白血病（B-ALL）臨床實踐指南進行了三項重要更新。其中包括：將BLINCYTO E1910方案列為費城染色體陰性成人患者一線治療的唯一首選方案；將BLINCYTO加入多藥聯合化療方案中，作為微小殘留病灶（MRD）陰性患者的鞏固治療；以及將BLINCYTO聯合酪氨酸激酶抑製劑方案提升至MRD陰性費城染色體陽性患者的首選治療方案。

Finally, in April, data were published in the New England Journal of Medicine, demonstrating that BLINCYTO added to chemotherapy, improved 2-year survival in KMT2A-rearranged B-ALL in infants compared to historical data. BLINCYTO 2-year survival was 93% versus 66% for chemotherapy alone.

最終，4月發表在《新英格蘭醫學雜誌》的數據顯示，KMT2A重排的嬰兒B細胞急性淋巴性白血病（B-ALL）患者中，化療合併BLINCYTO治療可提高2年存活率，優於歷史數據。 BLINCYTO治療組的2年存活率為93%，而單純化療組為66%。

If you look at the totality of the data, it is clear that BLINCYTO is changing the paradigm for the treatment of B-cell ALL. In late-stage disease, in early disease, in young patients and in older patients. We remain excited about its future potential and are focused on further investigating BLINCYTO in earlier lines of treatment and improving patient convenience through subcutaneous administration.

從整體數據來看，BLINCYTO 顯然正在改變 B 細胞急性淋巴性白血病 (B-ALL) 的治療模式。無論是在晚期或早期，無論是年輕患者或老年患者，BLINCYTO 都有效。我們對它的未來潛力充滿信心，並致力於進一步研究 BLINCYTO 在早期治療中的應用，以及透過皮下給藥來提高患者的便利性。

As the first BiTE, BLINCYTO also provides a road map for the development of molecules such as tarlatamab, which could have an enhanced activity in settings of lower tumor burden. Two additional early oncology programs to watch are Xaluritamig and AMG 193. Xaluritamig is a first-in-class STEAP1 targeting bispecific being studied in advanced prostate cancer where STEAP1 is expressed on almost all tumor cells. We are observing significant antitumor activity with this molecule and are rapidly enrolling dose expansion cohorts.

作為首個雙特異性抗體試驗（BiTE），BLINCYTO 也為 tarlatamab 等分子的研發提供了路線圖，這些分子在腫瘤負荷較低的情況下可能具有更強的活性。另外兩個值得關注的早期腫瘤學計畫是 Xaluritamig 和 AMG 193。 Xaluritamig 是一種首創的靶向 STEAP1 的雙特異性抗體，目前正在研究其在晚期前列腺癌中的應用，因為 STEAP1 幾乎在所有腫瘤細胞上都有表達。我們觀察到該分子具有顯著的抗腫瘤活性，並且正在快速招募劑量擴展隊列。

Xaluritamig provides another example of a bispecific T-cell engager demonstrating activity in a solid tumor setting. AMG 193 is a first-in-class small molecule MTA-cooperative PRMT5 inhibitor being studied in patients with advanced MTAP-null solid tumors. The overexpression of PRMT5 in the absence of MTAP leads to the accumulation of MTA, and we leverage this biology in the unique design of AMG 193, which requires the presence of MTA to effectively inhibit PRMT5.

Xaluritamig是另一種在實體腫瘤治療中展現活性的雙特異性T細胞銜接器。 AMG 193是一種首創的小分子MTA協同PRMT5抑制劑，目前正在MTAP缺失的晚期實體瘤患者中進行研究。在MTAP缺失的情況下，PRMT5的過度表現會導致MTA的積累，而AMG 193的獨特設計正是利用了這個生物學特性，其需要MTA的存在才能有效抑制PRMT5。

Alterations in this pathway occur in approximately 15% of solid tumors are often associated with a poor prognosis and historically have been very hard to [drug]. We are currently enrolling in Phase Ib/II study of AMG 193 and -- while it is early, we are encouraged by the antitumor responses we've observed in multiple tumor types. We look forward to sharing data from both Xaluritamig and AMG 193 this fall.

此通路發生改變的病例約佔實體腫瘤的15%，通常預後不良，且歷來難以用藥物治療。我們目前正在進行AMG 193的Ib/II期臨床試驗，雖然尚處於早期階段，但我們在多種腫瘤類型中觀察到的抗腫瘤反應令人鼓舞。我們期待今年秋季分享Xaluritamig和AMG 193的相關數據。

In General Medicine, we are advancing our cardiovascular franchise and emerging portfolio of obesity molecules with a focus on clinical trial execution. The Phase III outcome study of Olpasiran, our potentially best-in-class Lp(a) targeting small interfering RNA molecule in atherosclerotic cardiovascular disease is enrolling well as is a Phase II study of maridebart cafraglutide formerly known as AMG 133 in patients with obesity with or without diabetes and related comorbidities. The goal of the Phase II study is to generate data that will provide broad optionality to design a Phase III program, leveraging the unique properties of maridebart cafraglutide that will deliver strong, sustainable weight loss.

在內科領域，我們正致力於推動心血管產品線和新興的肥胖症藥物組合，重點在於臨床試驗的發展。我們針對動脈粥狀硬化性心血管疾病的潛在同類最佳的Lp(a)靶向小幹擾RNA分子Olpasiran的III期療效研究進展順利；同時，針對伴或不伴糖尿病及相關合併症的肥胖症患者，maridebart cafraglutide（曾用名AMG 133）的II期研究也進展良好。 II期研究旨在收集數據，為設計III期臨床試驗方案提供廣泛的選擇餘地，充分利用maridebart cafraglutide的獨特特性，實現強效且可持續的減重效果。

In May, as mentioned, we presented data from a real-world study of nearly 0.5 million postmenopausal women with osteoporosis in the United States Medicare program showing Prolia has substantially reduced fracture risk in patients versus oral alendronate. In addition, the same study showed that longer duration of Prolia treatment was associated with a greater reduction in major osteoporotic fracture risk. These data are a great demonstration of the importance of Prolia in treating postmenopausal osteoporosis and the ability to study treatment effect in large patient populations using real-world evidence.

如前文所述，我們在五月發表了一項來自美國醫療保險計劃（Medicare program）的真實世界研究數據，該研究納入了近50萬名患有骨質疏鬆症的停經後女性。研究結果顯示，與口服阿崙膦酸鈉相比，Prolia顯著降低了患者的骨折風險。此外，研究也表明，Prolia治療持續時間越長，主要骨質疏鬆性骨折風險的降低幅度越大。這些數據有力地證明了Prolia在治療停經後骨質疏鬆症的重要性，以及利用真實世界證據在大樣本患者群體中研究治療效果的能力。

In inflammation, beyond severe asthma, we are investigating multiple additional indications with TEZSPIRE, including separate Phase III studies in chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis. We also have 2 Phase II studies, 1 in chronic spontaneous urticaria and the other in COPD. The CSU study is complete with top line data anticipated imminently. The COPD trial was fully enrolled and has recruited a broad population of COPD patients, including patients with both high and low eosinophil counts. We look forward to the readout of this study in the first half of 2024.

在發炎領域，除了重度氣喘之外，我們正在利用TEZSPIRE探索多種其他適應症，包括針對伴隨鼻息肉的慢性鼻竇炎和嗜酸性食道炎的獨立III期研究。我們還有兩篇II期研究，一篇針對慢性自發性蕁麻疹，另一項針對慢性阻塞性肺病（COPD）。慢性自發性蕁麻疹研究已完成，預計很快將公佈初步數據。慢性阻塞性肺病試驗已完成全部入組，並招募了廣泛的慢性阻塞性肺病患者群體，包括嗜酸性粒細胞計數高低不同的患者。我們期待在2024年上半年獲得該研究的結果。

Rocatinlimab, a first-in-class anti-OX40 monoclonal antibody being investigated in patients with moderate-to-severe atopic dermatitis. Recruitment is off to a strong start on the ROCKET Phase III clinical development program. We are also planning to initiate a Phase II study in moderate-to-severe uncontrolled asthma as we explore rocatinlimab in this additional indication. Rounding out the clinical summary, we've continued to execute both on time and on budget with our biosimilars portfolio, including the recent initiation of a pivotal study evaluating the pharmacokinetic similarity of ABP 206 compared with OPDIVO, 1 of 6 planned new biosimilars.

羅卡汀利單抗（Rocatinlimab）是一種首創的抗OX40單株抗體，目前正在針對中度至重度異位性皮膚炎患者進行研究。 ROCKET III期臨床開發計畫的受試者招募工作已取得良好開端。我們也計劃啟動一項針對中重度未控制氣喘的II期研究，以探索羅卡汀利單抗在該適應症的應用。此外，我們的生物相似藥產品組合也持續按時按預算推進，包括近期啟動的一項關鍵性研究，該研究旨在評估ABP 206與OPDIVO（我們計劃推出的六種新生物類似藥之一）的藥物動力學相似性。

In closing, I'd like to highlight our recently announced collaboration with TScan Therapeutics. This is a multiyear collaboration that will use TScan's proprietary target discovery platform, TargetScan to identify the antigens recognized by T-cells in patients with Crohn's disease and represents a novel approach to investigating this tough-to-treat illness. I'd like to thank Amgen staff around the world for their relentless focus on execution as we work hard to meet the needs of the patients we serve.

最後，我想重點介紹我們近期宣布與TScan Therapeutics的合作。這是一項為期多年的合作，我們將利用TScan的專有標靶發現平台TargetScan，識別克羅恩病患者體內T細胞識別的抗原，這代表了一種研究這種難治性疾病的全新方法。我要感謝安進全球員工的不懈努力，他們始終專注於執行，並盡力滿足我們所服務患者的需求。

I'll now turn it over to Peter.

現在我把麥克風交給彼得。

Thank you, Dave. We're pleased with our strong second quarter performance, growing volume by 11%, increasing investment in research and development and delivering 8% year-over-year non-GAAP EPS growth. This drives our confidence in delivering against our 2023 objectives and keeps us in position to meet or beat our longer-term commitments. I'll review our second quarter results before discussing our 2023 guidance. As a reminder, these results and outlook reflect Amgen on a stand-alone basis without any adjustments for the announced Horizon acquisition.

謝謝戴夫。我們對第二季強勁的業績表現感到滿意，銷量成長了11%，研發投入增加，非GAAP每股收益較去年同期成長8%。這增強了我們實現2023年目標的信心，並使我們能夠達到甚至超越長期承諾。在討論2023年業績指引之前，我將先回顧第二季的業績。需要提醒的是，這些業績和展望反映的是安進公司獨立運營的情況，並未對已宣布的Horizo​​​​n收購進行任何調整。

Turning to our second quarter financial results, which are shown on Slide 41, total revenues of $7.0 billion grew 6% year-over-year and represents the highest quarterly revenues in Amgen's history. Product sales increased 8%, while total revenues increased 7% year-over-year, excluding the negative impact of foreign exchange rates. Second quarter total non-GAAP operating expenses increased 7% year-over-year. We invested in and advanced our pipeline and accelerated growth across our priority marketed products, while delivering a non-GAAP operating margin as a percent of product sales of 52.6%, demonstrating expense discipline.

第二季財務表現（詳見第41頁）顯示，總營收達70億美元，年增6%，創安進公司史上最高季度營收紀錄。剔除匯率負面影響後，產品銷售成長8%，總營收年增7%。第二季非GAAP營運總支出較去年同期成長7%。我們加大了對產品線的投資和研發投入，並加速了重點上市產品的成長，同時實現了52.6%的非GAAP營運利潤率（佔產品銷售額的百分比），展現了我們嚴格的成本控制能力。

Non-GAAP R&D spend in the quarter increased 7% year-over-year, reflecting growing investments in our pipeline, driven by higher spending on late-stage programs and marketed product support. Non-GAAP cost of sales as a percent of product sales increased 2.4 percentage points on a year-over-year basis to 17.1%, primarily driven by higher profit shares and changes in product mix.

本季非GAAP研發支出年增7%，反映出我們對產品線投入的增加，這主要得益於後期專案和已上市產品支援方面投入的增加。非GAAP銷售成本佔產品銷售額的百分比年增2.4個百分點至17.1%，主要原因是利潤份額增加和產品組合變化。

Non-GAAP SG&A expenses in the second quarter decreased 6% year-over-year. We continue to focus on our continuous improvement operating model, prioritizing investments, digitalization and driving productivity and beginning and in other cases, continuing what we have already started historically to execute in any number of uses of artificial intelligence. Non-GAAP other income and expenses were a net $307 million expense in the second quarter. This year-over-year favorability was driven primarily by the change in Beijing accounting from equity method to a mark-to-market investment with the impact included only in our GAAP results. As expected, our second quarter non-GAAP tax rate increased 1.7 percentage points to 16.4%, primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023.

第二季非GAAP銷售、管理及行政費用較去年同期下降6%。我們繼續專注於持續改善的營運模式，優先考慮投資、數位化和提高生產力，並在人工智慧的多個應用領域啟動（或在某些情況下繼續推進）我們歷來已開展的專案。第二季非GAAP其他收入和支出淨額為3.07億美元。這一同比利好主要源自於北京會計核算方法由權益法變更為市值計價法，而變更的影響僅計入我們的GAAP績效。如預期，第二季非GAAP稅率上升1.7個百分點至16.4%，主要原因是波多黎各2022年稅法變更，該變更將消費稅替換為所得稅，並於2023年開始實施。

We continue to execute on our capital allocation priorities. First, we continue our priority investments in the best innovation, both internal and external innovation. In Q2, we drove higher spend in late-stage programs such as AMG 133 and olpasiran as well as support for our marketed products, including TAVNEOS. Second, we continue investing in our business. Capital expenditures are at near peak levels, driven by simultaneous construction of our state-of-the-art manufacturing facilities in Ohio and North Carolina.

我們繼續推進資本配置優先事項。首先，我們持續優先投資於最佳創新項目，包括內部和外部創新。第二季度，我們加大了對後期專案的投入，例如AMG 133和olpasiran，並支援已上市產品，包括TAVNEOS。其次，我們持續投資自身業務。由於我們在俄亥俄州和北卡羅來納州同時建造最先進的製造工廠，資本支出已接近高峰。

We expect our annual capital expenditures to begin to decline starting in 2024, with the completion and licensing of our Ohio plant and capital expenditures will then begin to return closer to historical levels over the coming years. And third, we plan to continue to return capital to our shareholders. We paid dividends of $2.13 per share in the second quarter, representing a 10% increase over the second quarter of 2022.

我們預計，隨著俄亥俄州工廠的竣工和獲得許可，自2024年起，我們的年度資本支出將開始下降，並在未來幾年逐步恢復到歷史水平。第三，我們計劃繼續向股東返還資本。我們在第二季度派發了每股2.13美元的股息，較2022年第二季成長了10%。

The company generated $3.8 billion of free cash flow in the second quarter of 2023 versus $1.7 billion in the second quarter of 2022, primarily driven by the timing of tax payments and includes higher interest income and higher operating income. We expect strong cash flow for the remainder of the year, consistent with our full year 2023 financial outlook that includes a non-GAAP operating margin of roughly 50%.

該公司2023年第二季自由現金流為38億美元，高於2022年第二季的17億美元，主要受稅款支付時間的影響，其中包括更高的利息收入和更高的營業收入。我們預計今年剩餘時間現金流將保持強勁，這與我們對2023年全年財務展望一致，其中包括約50%的非GAAP營業利潤率。

Now turning to the outlook for the business for 2023 on Slide 43. Our guidance is currently provided on the Amgen stand-alone business and does not include any Horizon projections. As the Horizon transaction is expected to close by mid-December, resulting contributions from Horizon would be included after that period. Given our strong performance, we are raising our 2023 revenue guidance to $26.6 billion to $27.4 billion versus previous guidance of $26.2 billion to $27.3 billion. Although our results give us confidence to raise our full year guidance, we expect the third quarter sales may be lower compared to the second quarter due to the impact of the Medicare donut hole which is more pronounced in the second half of the year and also to certain favorable changes to estimated sales deductions in the second quarter.

現在就來看看第43頁幻燈片中關於2023年業務展望的內容。我們目前的業績指引是基於安進獨立業務的，不包含任何Horizo​​​​n的預測。由於Horizo​​n交易預計將於12月中旬完成，屆時Horizo​​n的業績貢獻將計入業績指引。鑑於我們強勁的業績表現，我們將2023年營收指引從先前的262億美元至273億美元上調至266億美元至274億美元。儘管我們的業績讓我們有信心上調全年業績指引，但我們預計第三季度銷售額可能低於第二季度，原因是醫療保險「甜甜圈漏洞」（Medicare donut hole）的影響在下半年更為顯著，以及第二季度預計銷售額扣除額的某些有利變化。

Regarding our non-GAAP earnings per share guidance, we intend to increase investments in our internal innovation and priority marketed products from a position of strength, given the acceleration in our business and our pipeline. Reflecting our improved revenue outlook, along with our investment plans, we are revising our non-GAAP EPS guidance to $17.80 to $18.80 versus previous guidance of $17.60 to $18.70. Again, although our results give us confidence to raise our full year non-GAAP EPS, we expect third quarter non-GAAP EPS to be lower compared to the second quarter, resulting from the expected Q3 sales and our investments in the business.

關於我們的非GAAP每股收益預期，鑑於公司業務和產品線的加速發展，我們計劃加大對內部創新和重點市場產品的投入。考慮到我們改善的營收預期以及投資計劃，我們將非GAAP每股收益預期從先前的17.60美元至18.70美元上調至17.80美元至18.80美元。儘管我們的業績讓我們有信心提高全年非GAAP每股收益預期，但由於預期中的第三季銷售額以及我們對業務的投資，我們預計第三季非GAAP每股收益將低於第二季。

Important additional points to consider as you model the remainder of 2023. We now project full year Neulasta sales of approximately $800 million and full year combined KANJINTI and MVASI sales of approximately $900 million. We now expect other revenue for 2023 to be in the range of $1.1 billion to $1.3 billion versus our prior range of $1.2 billion to $1.5 billion. Note that our third quarter 2022 results included about $90 million of other revenue related to our COVID antibody manufacturing agreement and the milestone we earned that we do not expect to repeat in the third quarter of 2023.

在2023年剩餘時間進行預測時，需要考慮以下重要補充要點。我們目前預計Neulasta全年銷售額約為8億美元，KANJINTI和MVASI全年合併銷售額約為9億美元。我們現在預計2023年其他收入將在11億美元至13億美元之間，而先前的預期為12億美元至15億美元。請注意，我們2022年第三季的業績包含了約9,000萬美元的其他收入，這些收入與我們新冠抗體生產協議以及我們獲得的里程碑付款有關，我們預計2023年第三季不會再出現類似情況。

We anticipate full year non-GAAP operating expense for 2023 to increase by closer to 3% versus last year compared to our previous estimate of a 1% increase with higher cost of sales from projected increased sales, additional investments driving our innovative pipeline and increased support for our growing priority marketed products including Repatha and Otezla. We continue to expect the full year 2023 operating margin as a percentage of product sales to be roughly 50%, although it will vary in each of the remaining 2 quarters.

我們預計2023年全年非GAAP營運費用將比上年成長約3%，高於先前1%的預期。成長的主要原因是銷售成本上升（源自於預期銷售額成長）、對創新產品線的額外投資以及對包括Repatha和Otezla在內的重點上市產品的支持力度加大。我們仍預期2023年全年營運利潤率（佔產品銷售額的百分比）約為50%，但剩餘兩季的具體數值可能會有所不同。

We continue to expect non-GAAP cost of sales as a percentage of product sales to be between 16% and 17%. We now expect our non-GAAP R&D expenses in 2023 to increase about 5% year-over-year which is higher than our prior guidance of 3% to 4%. We continue to expect non-GAAP SG&A spend to be slightly down year-over-year as a percentage of product sales. We now expect non-GAAP other income and expenses to be in the range of [$1.1 billion to $1.2 billion] down from the prior guidance of $1.2 billion to $1.3 billion.

我們仍預期非GAAP銷售成本佔產品銷售額的比例將介於16%至17%之間。我們現在預計2023年非GAAP研發費用將年增約5%，高於先前3%至4%的預期。我們仍預期非GAAP銷售、管理及行政費用佔產品銷售額的比例將略有下降。我們現在預計非GAAP其他收入和支出將在11億美元至12億美元之間，低於先前12億美元至13億美元的預期。

For the full year, we anticipate a non-GAAP tax rate of 17.5% to 18.5%, down from prior guidance of 18.0% to 19.0%. We expect Q3's tax rate to be near the upper end of the revised range of 17.5% to 18.5%. Our capital expenditure guidance remains unchanged at approximately $925 million in 2023. Our confidence is strong in the long-term outlook and long-term growth for Amgen. And we look forward to completing the announced acquisition of Horizon by mid-December, as Bob indicated, I'm incredibly grateful to our 24,000-plus colleagues for successfully executing on our mission of serving patients in the second quarter and beyond.

我們預計全年非GAAP稅率為17.5%至18.5%，低於先前18.0%至19.0%的預期。我們預計第三季稅率將接近修訂後區間17.5%至18.5%的上限。我們2023年的資本支出預期維持不變，約9.25億美元。我們對安進的長期前景和長期成長充滿信心。正如鮑伯所說，我們期待在12月中旬完成對Horizo​​​​n的收購。我非常感謝我們超過24,000名同事，感謝他們在第二季度及以後成功地完成了服務患者的使命。

This concludes the financial update. I'll turn it over to Bob for Q&A.

財務報告到此結束。接下來交給鮑伯回答問題。

Okay. Thank you, Peter. And now we'll open the line for callers, so they can ask questions, and I'll just ask our operator to remind you of the procedures for doing that, please.

好的。謝謝你，彼得。現在我們開通電話，供聽眾提問，我請接線生提醒您提問流程，謝謝。

(Operator Instructions) Our first question comes from Mohit Bansal from Wells Fargo.

（操作員說明）我們的第一個問題來自富國銀行的 Mohit Bansal。

Congrats on the quarter. Maybe one question on -- One question on OX40. There are some concerns and people are talking about the safety of OX40 like one concern is regarding the autoimmune phenomena, and I'm reading some literature and suggest that in OX40 -- lacking OX40 animal models, there is an impairment of interferon-gamma. So just trying to understand how are you managing that risk in this particular drug? And how -- is it autoimmune phenomena? Is it a concern at all?

恭喜您本季取得佳績。關於OX40，我有一個問題。有人擔心OX40的安全性，例如自體免疫反應。我閱讀了一些文獻，其中提到OX40（目前缺乏OX40動物模型）會抑制干擾素-γ的產生。我想了解一下，您是如何控制這種藥物的這種風險的？自體免疫反應真的存在嗎？這是否值得擔憂？

This is Dave. So we're aware of those conversations. What I can tell you is that let me approach your question in 2 parts. One, mechanistically, OX40 is primarily expressed on activated T-cells and activated pathogenic T-cells in the setting of atopic dermatitis. In the Phase II program, we did not observe autoimmune phenomena. Obviously, this is something we are tracking of, but we have no clinical signal or indication of such concerns at this time.

我是Dave。我們已經了解了這些討論。我可以分成兩部分來回答您的問題。首先，從機制上講，OX40主要在活化的T細胞和異位性皮膚炎患者體內活化的致病性T細胞上表現。在II期臨床試驗中，我們並沒有觀察到自體免疫現象。當然，我們會持續關注這方面的情況，但目前我們還沒有發現任何相關的臨床訊號或跡象。

Likewise, your question regarding interferon gamma would imply risk, for example, for infections. That's also something that we did not see at a greater rate in treated patients than placebo in the Phase II program. These are things that we will follow. They're followed routinely for almost all cytokine inhibition programs. But to date, we have not had a signal.

同樣，您關於幹擾素γ的問題也暗示了感染等風險。在二期臨床試驗中，我們並未發現治療組患者的感染率高於安慰劑組。我們會持續關注這些方面，幾乎所有細胞激素抑制劑治療計畫都會常規進行這些方面的監測。但迄今為止，我們尚未發現任何異常訊號。

Our next question comes from Michael Yee from Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

Bob commented about the enthusiasm for the Horizon deal. I know in general, there's a lot of uncertainty in the TED market going on with sales. Can you maybe just describe your ongoing confidence with what you think is going on in the TED market, why you're excited about this and your confidence around regrowing this business? And have you been in discussions or at least aware of the ongoing dynamics or at least an ongoing dialogue with the company about the market for TED.

鮑伯談到了大家對Horizo​​​​n交易的熱情。我知道目前TED市場的銷售狀況有許多不確定性。您能否談談您對TED市場現況的信心，以及您對這項交易感到興奮和重振這項業務的信心？您是否曾與該公司就TED市場進行討論，或至少了解市場動態，或至少保持對話？

Sure, Michael. I'll answer it in 2 parts. Maybe I'll kick it over to Murdo in a moment. But let me just reiterate that we remain very excited. And of course, we're watching carefully developments in the marketplace and talking as appropriate with our friends at Horizon about that. And again, based on our view of the clinical data and our view of the international opportunities and the ability to expand the reach of the product, we're very excited about what we think we can do there. But Murdo, why don't you elaborate further?

當然，邁克爾。我會分兩部分回答。也許一會兒我會把這個問題轉給默多。但我想再次強調，我們仍然非常興奮。當然，我們正在密切關注市場動態，並酌情與Horizo​​​​n的朋友們進行溝通。再次強調，基於我們對臨床數據、國際機會以及產品推廣能力的評估，我們對未來能達成的成就感到非常興奮。默多，你能否進一步闡述？

Yes. From our vantage point, Michael, we see strong execution by the Horizon team in the U.S., and there are several catalysts for growth here. They've already expanded their commercial footprint, and so that should start to take traction. They have the data now for the low CAS patient population with the positive results from that trial in public domain, not yet published, but in public domain, having been presented and in hand with their sales forces. So that's very recent and not reflected necessarily in their historical performance.

是的。邁克爾，從我們的角度來看，Horizo​​n團隊在美國的執行力很強，而且有幾個因素會促進其成長。他們已經擴大了商業版圖，這應該會開始產生效果。他們現在掌握了低CAS患者族群的數據，該試驗的正面結果已公開，雖然尚未正式發表，但已向銷售團隊展示並掌握。所以這是最近才有的進展，尚未完全反映在他們以往的業績上。

Bob mentioned the international market launches. We continue to believe post close, we will be able to help accelerate the work being done there. We're also seeing some improved medical policies being issued prior to the new calendar year. And so that's very encouraging to see payers improve or remove restrictions, I should say, on the use of TEPEZZA for the lower CAS patient population.

鮑伯提到了國際市場的推出。我們仍然相信，交易完成後，我們將能夠幫助加速這方面的工作。我們也看到，在新的一年到來之前，一些改進的醫療政策已經推出。因此，看到支付方改善或取消對低CAS患者群體使用TEPEZZA的限制，這令人非常鼓舞。

So there are many good catalysts and what I see is Horizon systematically unlocking those additional opportunities for growth, and we remain quite bullish on TEPEZZA's utility across a very large population of thyroid eye disease patients who would benefit from that treatment given the clinical data. The last thing I should mention on TEPEZZA is they also were able to replicate the low CAS population results in OPTIC-J -- in their OPTIC-J trial, sorry, they're not the low CAS, but the registrational data for thyroid eye disease and OPTIC-J. So that sets them up well for future potential launch in Japan.

因此，目前有許多有利的催化劑，我看到Horizo​​​​n正在系統性地釋放這些額外的成長機會。鑑於臨床數據，我們仍然非常看好TEPEZZA在大量甲狀腺眼疾患者中的應用前景，這些患者將從該療法中獲益。關於TEPEZZA，我最後要提到的是，他們還在OPTIC-J試驗中成功復現了低CAS人群的結果——抱歉，他們並非在OPTIC-J試驗中獲得了低CAS人群的結果，而是在甲狀腺眼病和OPTIC-J的註冊數據中獲得了結果。這為他們未來在日本的潛在上市奠定了良好的基礎。

So really good data flow, really good execution and investment and focus here. And look, beyond TEPEZZA, we also remain very excited about their other 2 large in-line brands with KRYSTEXXA and obviously, UPLIZNA. So overall, we remain excited and confident that the 2 companies working together on this really strong portfolio will be a good pairing.

所以，這裡的數據流、執行力、投資和專注度都非常出色。而且，除了TEPEZZA之外，我們也對他們旗下的另外兩個大型品牌KRYSTEXXA和UPLIZNA充滿期待。總而言之，我們仍然對這兩家公司攜手打造如此強大的產品組合充滿信心，相信這將是一次完美的合作。

Our next question comes from Salveen Richter from Goldman Sachs.

下一個問題來自高盛的薩爾文·里希特。

Could you put the top line Phase II data for tarlatamab in small cell lung cancer into context for us and share any more details on the profile, in particular, how does this compare to the Phase I data where you had a confirmed objective response rate of 23% and a median duration of response of 13 months. I think you noted it substantially exceeds the Phase I results.

您能否為我們解讀tarlatamab治療小細胞肺癌的II期臨床試驗主要數據，並分享更多關於其療效特徵的細節，特別是與I期臨床試驗數據相比如何？ I期臨床試驗中，確認的客觀緩解率為23%，中位緩解持續時間為13個月。我記得您提到過，II期臨床試驗的結果顯著優於I期臨床試驗。

Yes, Salveen, thanks for the question. Very, very excited about this molecule. If you step back, I think it represents what we had hoped to see in the BiTE platform and substantial clinical effects in a major solid tumor to put the data in the context in comparison to our Phase I. As noted, we substantially exceeded the 23% response rate that we reported in Phase I. We are planning to present these data at a fall conference. I'm embargoed, of course, in terms of providing more specifics. But I can tell you that I couldn't be more pleased with the response rate data, the duration of response and overall survival.

是的，Salveen，謝謝你的提問。我對這個分子感到非常非常興奮。總的來說，我認為它代表了我們一直以來在BiTE平台中期望看到的結果，並且在一種主要實體瘤中展現出了顯著的臨床療效，這可以作為我們I期臨床試驗數據的參考。如同先前所提到的，我們大幅提高了I期臨床試驗中所報告的23%的緩解率。我們計劃在秋季的會議上公佈這些數據。當然，由於保密協議，我無法提供更多細節。但我可以告訴你，我對緩解率、緩解持續時間和總存活期的數據都非常滿意。

For context, in patients with small cell lung cancer in the third line, response rates are typically well under 50%. But importantly, they are vanishingly brief in most instances, often a matter of weeks or a few months. And so based on what we're observing, I think we really have a chance to change the natural history of this disease particularly as we march towards earlier lines of therapy where the activity of the BiTE in a lower tumor disease burden setting should be enhanced as we have observed with BLINCYTO. So all of our efforts now are focused on executing earlier line trials. So this is one to, I think, pay attention to as we go forward, and we're really looking forward to presenting these results this fall.

作為背景，在小細胞肺癌三線治療中，緩解率通常遠低於50%。但重要的是，在大多數情況下，緩解期非常短暫，往往只有幾週或幾個月。因此，根據我們觀察到的情況，我認為我們確實有機會改變這種疾病的自然病程，尤其是在我們推進早期治療方案時，正如我們在BLINCYTO研究中觀察到的那樣，在腫瘤負荷較低的情況下，BiTE的活性應該會增強。因此，我們目前的所有努力都集中在進行早期治療試驗。我認為，這是我們未來需要關注的重點，我們非常期待在今年秋天公佈這些結果。

Dave, do you want to say anything about safety here, obviously...

戴夫，你顯然想就安全問題​​說點什麼吧…

In terms of the safety, I think we have learned a lot in the development program about the clinical management here. We're quite pleased with the rates of -- in principle side effects like cytokine release syndrome and we'll look forward to sharing those details as well when we present the data this fall, but exceptionally happy with the tolerability and safety profile as well.

就安全性而言，我認為我們在研發過程中對臨床管理方面有了更深入的了解。我們對細胞激素釋放症候群等副作用的發生率基本滿意，並期待在今年秋季公佈數據時分享這些細節。同時，我們也對產品的耐受性和安全性感到非常滿意。

Next question comes from Jay Olson from Oppenheimer.

下一個問題來自奧本海默公司的傑伊·奧爾森。

Congrats on the quarter and especially the tarlatamab and LUMAKRAS results and happy birthday to Arvind. For the LUMAKRAS Phase III in colorectal cancer, can you just talk about the filing strategy and time line and maybe a little bit about the market opportunity in CRC for LUMAKRAS?

恭喜本季取得佳績，尤其恭喜tarlatamab和LUMAKRAS試驗結果優異，也祝Arvind生日快樂。關於LUMAKRAS在結直腸癌領域的III期臨床試驗，您能否談談申請策略和時間表，以及LUMAKRAS在結直腸癌領域的市場前景？

Yes. In regards -- this is obviously a smaller patient population, about 4% of colorectal cancers harbor the G12C mutation. In terms of next steps here, our plans are to have discussions with the FDA and other regulatory authorities on these Phase III data. And as those conversations unfold, I'll provide guidance about the potential regulatory pathway. And then as I mentioned, based on the strength of these data and Phase Ib data, in the first-line setting using a Vectibix chemotherapy, LUMAKRAS combination. We are also advancing a Phase III trial in first-line disease. So I think it's full steam ahead in colorectal cancer as well. And again, I'll give guidance about next steps as we've had the appropriate conversations.

是的。關於這一點－顯然，這部分患者族群較小，約4%的大腸癌患者帶有G12C突變。下一步，我們計劃就這些III期數據與FDA和其他監管機構進行討論。隨著討論的深入，我會就潛在的監管途徑提供指導。正如我之前提到的，基於這些數據以及Ib期數據的優勢，我們正在推進Vectibix化療聯合LUMAKRAS的第一線治療方案。此外，我們也正在推動一項針對第一線疾病的III期臨床試驗。所以我認為，在大腸直腸癌領域，我們也在全力推動。同樣，在進行相關討論後，我會就下一步措施提供指導。

Our next question comes from Chris Raymond from Piper Sandler.

我們的下一個問題來自Piper Sandler公司的Chris Raymond。

Warm birthday wishes to Arvind from us here at Piper as well. Just a question on AMJEVITA. So obviously, the uptake in the U.S. has not been maybe what was originally sort of contemplated when you guys were first talking about that opportunity. But maybe a couple of questions. Can you maybe talk about, first, maybe the split in scripts between the high and low priced SKU?

Piper全體同仁也向Arvind致以熱烈的生日祝福。關於AMJEVITA，我有個問題。顯然，該產品在美國的市場表現可能沒有達到你們最初設想的水平。我有幾個問題想請教一下。首先，能否談談高價和低價SKU在處方藥銷售上的差異？

And then second, maybe there's been a lot of talk around what AbbVie has done to sort of blunt uptake biosimilars to date. What, if anything, on their part has surprised you guys maybe the most in terms of what they've done? And what's the plan maybe going forward?

其次，大家可能一直在討論艾伯維迄今為止為遏制生物相似藥的普及所採取的措施。就他們目前採取的措施而言，最令你們感到驚訝的是什麼？他們未來的計畫又是什麼？

Sure. Will you take that, Murdo?

當然。你收下這個好嗎，默多？

Sure. Thank you for the question, Chris. We're obviously very early innings still in this biosimilar market with AMJEVITA, and we're seeing clearly what is new payer behavior in light of such a large product having biosimilar competition.

當然。謝謝你的提問，克里斯。顯然，我們目前在生物相似藥市場還處於非常早期的階段，AMJEVITA 就是其中之一。我們正在清楚地看到，面對如此龐大的產品面臨生物相似藥的競爭，支付方的行為發生了哪些變化。

With respect to the high versus the low, we're -- it's kind of a different mix. We see mostly the high in PBM utilization and the low in the IDN utilization where the low cost -- low net cost is attractive to them. But again, it's very early, and the product mix, I don't think has settled out yet between those 2 SKUs. I would also say that we're still waiting to see what happens in the next payer negotiation cycle going into 2024. As you've seen many of the PBMs are on record as saying that they haven't done a whole lot in terms of driving utilization of biosimilars in 2023, but plan to do more of that in 2024. So I think there's a lot more to follow here.

關於高價和低價的情況，我們目前看到的是不同的組合。我們看到，高價主要出現在藥品福利管理機構（PBM）的使用中，而低價則主要出現在整合醫療網絡（IDN）的使用中，因為低成本——尤其是低淨成本——對他們來說很有吸引力。但話說回來，現在還處於非常早期的階段，我認為這兩種SKU之間的產品組合尚未最終確定。我還想說，我們仍在等待觀察2024年下一輪支付方談判週期的情況。正如您所看到的，許多PBM都公開表示，他們在2023年並沒有在推動生物相似藥的使用方面做太多工作，但計劃在2024年加大力度。所以我認為這方面還有很多值得關注的地方。

And with respect to AbbVie strategy, look, we compete against them in the innovative side and we now compete against them with our biosimilar, and we know their practice as well. So not a lot of surprises there. But I think the clarity of how pharmacy benefit works with biosimilar uptake or lack thereof is becoming clear to us and to other biosimilar manufacturers and other on lookers. So more to follow there.

至於艾伯維的策略，我們之前在創新領域與他們競爭，現在又在生物相似藥領域與他們競爭，我們也了解他們的做法。所以這並不令人意外。但我認為，藥房福利如何影響生物相似藥的普及程度（或缺乏普及程度）這一點，我們、其他生物相似藥生產商以及關注者都逐漸看清了。所以，後續還有更多進展。

I would say, though, we remain very excited about the growth of biosimilars in the longer term. We continue -- as Dave mentioned, we continue to commit research investment in the development of additional biosimilars with most recently with the initiation of ABP 206, a biosimilar to OPDIVO. We also are continuing to look at being able to launch other biosimilars in the medical benefit reimbursement system in the U.S. and that's where we were successful, obviously, with KANJINTI and MVASI in our previous launches.

不過，我想說的是，我們仍然對生物相似藥的長期發展前景感到非常樂觀。正如戴夫所提到的，我們將繼續加大研發投入，開發更多生物相似藥，最近啟動的ABP 206就是OPDIVO的生物類似藥。我們也努力爭取讓其他生物相似藥能夠進入美國的醫療保險報銷體系，顯然，我們之前成功推出了KANJINTI和MVASI。

So going forward, the majority of our biosimilar growth will come from ex U.S. and U.S. medical benefit biosimilars and we continue to believe we'll be able to generate strong growth, having previously said that we would more than double our 2021 annual sales of roughly $2 billion.

因此，展望未來，我們生物相似藥的大部分成長將來自美國以外的和美國醫療福利生物類似藥，我們仍然相信我們將能夠實現強勁增長，此前我們曾表示，我們將把 2021 年約 20 億美元的年銷售額翻一番以上。

Our next question comes from Umer Raffat from Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Umer Raffat。

So congrats on all the data. My question is 3.5 months was the PFS in the prior data, I think it was 20-plus percent response rate. And judging by the way you were describing that as transformative. Is it fair to say PFS also improved in a meaningful way in the [DLL3] study?

恭喜你分享了所有數據。我的問題是，先前的數據中，PFS（無惡化存活期）是3.5個月，我記得當時的緩解率超過20%。而且根據你對當時結果的描述，這可以說是具有變革性的。那麼，在[DLL3]研究中，PFS是否也得到了顯著改善呢？

And secondly, back on the Horizon deal, I feel like 2 things are clear. You're very committed to the deal, but also that depends falling dramatically short, at least so far, and the question that's coming up from investors is, is there any way to renegotiate the purchase price?

其次，回到Horizo​​​​n的交易，我覺得有兩點很明確。你對這筆交易非常投入，但至少到目前為止，這筆交易的成敗還遠遠沒有達到預期。投資人提出的問題是，有沒有可能重新協商收購價格？

Yes. What I can say, Umer, without getting into specifics on the number being under embargo is that I'm very happy with the efficacy package, overall response rate, progression-free survival, duration of response and overall survival, and we'll have a presentation of all of those data at an upcoming medical congress. But to me, it's a very, very compelling efficacy package.

是的。烏默，我可以說的是，雖然具體數字目前處於保密狀態，但我對療效數據非常滿意，包括總緩解率、無進展生存期、緩解持續時間和總生存期，我們將在即將召開的醫學大會上公佈所有這些數據。但對我來說，這是一套非常非常有說服力的療效數據。

Okay. And on Horizon, Umer, you're right, we remain enthusiastic about proceeding on the basis of the deal that we announced. I would take issue at least -- our perspective is different from what was implicit in your question, but we'll leave that for another day.

好的。關於Horizo​​n項目，Umer，你說得對，我們仍然熱衷於按照我們之前宣布的協議繼續推進。至少我有個異議——我們的觀點與你問題中隱含的意思有所不同，但我們改天再討論這個問題。

Our next question comes from Yaron Werber from TD Cowen.

下一個問題來自 TD Cowen 公司的 Yaron Werber。

I have a question on Otezla and sort of is relating to Enbrel too. Specifically, Enbrel sort of bouncing back, which is good to see, it looks like that's really a net benefiting from the contracting that you've put in place, given AMJEVITA and generic Humira. Otezla though (inaudible) which is actually doing pretty well in terms of uptake. It's got a benign label and obviously, a drug program. What gives you a lot of confidence in the outlook ahead?

我有個關於Otezla的問題，也跟Enbrel有點關係。具體來說，Enbrel的銷量似乎有所回升，這很好，看起來確實得益於你們實施的合同，尤其是考慮到AMJEVITA和仿製藥Humira。至於Otezla（聽不清楚），它的市場接受度其實相當不錯。它的標籤比較溫和，而且顯然也有相應的藥物項目。是什麼讓您對未來的前景如此充滿信心？

Thanks, Yaron, for the question. Yes, you're right. Enbrel has -- did have a strong quarter and is benefiting from, quite frankly, the best access we've ever had on Enbrel, where we've covered across all the major PBMs now. So we're seeing really nice new patient growth on Enbrel. So more new patients coming on to treatment with Enbrel, and we think that, that will support sustained volume through the course of the year. We did give up a bit of price to do that. So that's also flowing through Enbrel.

謝謝 Yaron 的提問。是的，你說得對。恩利（Enbrel）本季表現強勁，坦白說，這得益於我們迄今為止在恩利方面擁有的最佳市場准入管道，我們現在已經涵蓋了所有主要的藥品福利管理機構（PBM）。因此，我們看到恩利的新患者數量增長非常可觀。越來越多的新患者開始接受恩利治療，我們認為這將有助於全年銷售的持續成長。為了實現這一點，我們確實做出了一些價格上的讓步。所以，這也對恩利的銷售產生了正面影響。

But overall, I think there were some concerns perhaps last quarter that the biosimilar activity in the category was somehow impacting Enbrel and I was pretty clear last quarter that, that wasn't what we were seeing, and it's definitely now clear in second quarter that biosimilar competition for Humira is not negatively impacting Enbrel. So we're -- we see stability in Enbrel going forward.

但總的來說，我認為上個季度可能有人擔心生物相似藥的市場活動會對恩利（Enbrel）產生影響，而我上個季度已經明確表示，這種情況並未發生。現在第二季的情況也更加明確，阿達木單抗（Humira）的生物相似藥競爭並未對恩利造成負面影響。因此，我們預期恩利的市場將保持穩定。

For Otezla, we're actually seeing some strength in Otezla. We are pleased with what new patient acquisition looks like. We think we can do better. And we -- as I mentioned in my prepared remarks, are investing more in Otezla through the back end of this year, and Peter also mentioned that. And the reason we're optimistic is we're gaining momentum in helping those post topical, first systemic patients. And the epi here is pretty significant. There's 1.5 million of these patients in the U.S. that persist with topical treatment that would be better being initiated on a systemic agent, and Otezla is really the ideal for a systemic agent.

對於奧特茲拉（Otezla），我們確實看到了它的優勢。我們對新患者的獲取感到滿意。但我們認為可以做得更好。正如我在事先準備好的演講稿中提到的，我們將在今年下半年加大對奧特茲拉的投入，彼得也提到了這一點。我們之所以樂觀，是因為我們在幫助那些局部治療後首次接受全身性治療的患者方面取得了進展。而且，這個群體相當龐大。在美國，有150萬這樣的患者堅持使用局部治療，但他們如果能開始使用全身性藥物治療會更好，而奧特茲拉正是理想的全身性藥物。

We have great commercial coverage with Otezla with very little prior authorization requirement. We have no testing requirement for initiation and the affordability in out-of-pocket is very good. So Otezla is an attractive option for PBMs and payers to maintain on their formularies. And it's an easy option for dermatologists as the first systemic agent that they would choose for a patient coming off of topicals and being treated. And again, this milder form of disease, and no one else has indicated for that mild population from a systemic perspective. So overall, the thesis is good.

Otezla 擁有良好的商業保險覆蓋範圍，幾乎無需事先授權。啟動治療無需任何檢測，自付費用也非常實惠。因此，Otezla 對藥品福利管理機構 (PBM) 和付款方來說，是值得保留在藥品目錄中的理想選擇。對於皮膚科醫生而言，Otezla 也是一個便捷的選擇，可以作為停用外用藥後接受全身治療的患者的首選藥物。此外，Otezla 適用於病情較輕的患者，目前尚無其他藥物從全身治療的角度推薦用於此類輕症患者。總而言之，Otezla 的療效顯著。

Now I think Sotyktu coming into the market clearly put pressure on us where there are patients who are probably on our oral and didn't have full resolution of their psoriasis symptoms, and they would have switched to Sotyktu. What we're seeing is that, that has slowed. We are losing less to Sotyktu in our current mix of patients that we have on Otezla and we think that the other dynamic that put pressure on us in the first part of the year was the topical treatments also had free goods programs out there, and they were getting trial, and that has abated. They flattened out.

現在我認為，Sotyktu 的上市顯然給我們帶來了壓力，因為一些正在服用我們口服藥物但銀屑病症狀未完全緩解的患者可能會轉而使用 Sotyktu。但我們看到，這種情況已經有所緩解。在我們目前使用 Otezla 的患者群體中，轉而使用 Sotyktu 的患者數量有所減少。我們認為，今年上半年給我們帶來壓力的另一個因素是，外用治療藥物也推出了免費試用活動，但這些活動已經減少，市場趨於穩定。

So we're getting less pressure from topicals and much less patient movement away from Otezla to Sotyktu . So I think we really have to see into '24 how the access will evolve for the novel agents, but we're very confident with our current access and the current perception of the safety and efficacy of Otezla, we can further penetrate that population of patients. So going forward, we're feeling good about it.

因此，我們面臨的來自外用藥物的壓力減輕，患者從 Otezla 轉向 Sotyktu 的情況也大大減少。所以我認為，我們確實需要觀察 2024 年新型藥物的市場准入情況如何發展，但我們對目前的市場准入情況以及 Otezla 安全性和有效性的良好口碑非常有信心，相信我們能夠進一步擴大患者群體。因此，展望未來，我們充滿信心。

Our next question comes from Gregory Renza from RBC Capital Markets.

下一個問題來自加拿大皇家銀行資本市場的格雷戈里·倫扎。

Great. Congrats on the quarter. Bob, we certainly appreciate you framing up the case for the Horizon deal before the eyes of regulators and the courts. And maybe just to build on the conviction that you laid out. I just wanted to ask on your thoughts on the implication to potentially a negative outcome on the biopharma value creation ecosystem and essentially the ability for companies like Amgen to bring medicines to patients. So if we just call it that this novel legal theory like bundling does prevail. What impact would that have? And maybe to that, how far would you and the Amgen team have really been going to take this to preserve that opportunity to close the deal?

太好了。恭喜你本季的出色表現。鮑勃，我們非常感謝你向監管機構和法院闡述了Horizo​​​​n交易的理由。或許，為了進一步闡述你的觀點，我想問你，如果這種類似「捆綁銷售」的新型法律理論最終勝出，會對生物製藥價值創造生態系統，以及像安進這樣的公司向患者提供藥物的能力產生怎樣的潛在負面影響？這會帶來什麼影響？此外，為了保住完成交易的機會，你和安進團隊究竟會採取哪些措施？

Well, again, I think I would reiterate what I said in my prepared remarks, right, which is that we don't believe that their case is based on any established antitrust law. We think it's based on hypotheticals and speculative notions. And we look forward to having a chance to assert that in court.

嗯，我再次重申我事先準備好的發言稿，那就是我們認為他們的訴訟並非基於任何既定的反壟斷法，而是基於假設和推測。我們期待有機會在法庭上闡明這一點。

And again, we expect to prevail in court. And I think what's implicit in your question is the recognition that we live in a very fragmented industry and that there are a lot of innovators in particular that emphasized that it makes it difficult for them to capitalize on the full potential of their innovation, especially globally.

我們再次重申，我們預期會在法庭上勝訴。我認為你的問題隱含著一個事實：我們身處一個高度分散的產業，許多創新者都強調，這種分散化使得他們難以充分發揮創新的潛力，尤其是在全球範圍內。

And so there is a role for companies like ours to play in bringing value to companies like Horizon. We've talked about it repeatedly, but we think the capabilities we have with our global commercial organization, the demonstrated expertise we have in manufacturing, research and development for products like this, I think will enable us to reach far more patients than the company would be able to on its own.

因此，像我們這樣的公司可以在為像Horizo​​​​n這樣的公司創造價值方面發揮作用。我們已經多次討論過這個問題，但我們認為，憑藉我們全球商業機構的能力，以及我們在此類產品的製造、研發方面所展現的專業知識，我們將能夠比公司本身所能覆蓋到更多的患者。

So this is an industry that has flourished by being able to capitalize on the innovation ecosystem that exists for biotechnology companies for the most part in the United States. And again, we expect that, that will continue and I think that where not possible for companies to combine to benefit from each other's strengths, the result would be fewer innovation reaching fewer patients. So that would be an unfortunate outcome.

因此，這個產業之所以能夠蓬勃發展，很大程度上得益於美國現有的生技公司創新生態系統。我們預計這種情況將會持續下去。我認為，如果企業無法合作，發揮彼此的優勢，最終的結果將是創新成果減少，惠及的病人也減少。這將會是一個令人遺憾的結果。

Our next question comes from Evan Seigerman from BMO.

我們的下一個問題來自BMO的Evan Seigerman。

Maybe one for you, Dave. Can you just expand on the biologic rationale to target STEAP1 versus PSMA in prostate cancer. And I'm asking this in context of an update we had from our competitors today, where their PSMA program different than yours, they had to modify significantly due to safety issues.

戴夫，或許這個問題你想問你。能詳細解釋一下在治療攝護腺癌時，標靶STEAP1而非PSMA的生物學原理嗎？我之所以問這個問題，是因為我們今天收到了競爭對手的最新進展，他們的PSMA標靶治療方案與你們的方案不同，但由於安全問題，他們不得不做出重大調整。

Thanks, Evan. We're -- so a couple of reasons to target STEAP1. #1, it's almost universally expressed on advanced cancer cells. There is not an extensive high-level normal tissue expression, so that allows you to generate the therapeutic window that we're always looking for with bispecific T-cell engagers. PSMA has been a challenging target. There appear to be unique properties with that target. As I think you're aware, multiple molecules, including some of our own, have gone into and then fallen out of clinical development. And I've come to the belief that, that may be in part target-related.

謝謝，Evan。我們選擇STEAP1作為標靶有兩個原因。首先，它幾乎普遍表​​達於晚期癌細胞。在正常組織中，STEAP1的表達量並不高，這使得我們能夠利用雙特異性T細胞銜接器來建立我們一直在尋找的治療窗口。 PSMA一直是個具有挑戰性的標靶。這個靶點似乎具有一些獨特的性質。我想您也知道，包括我們自己的一些分子在內，許多分子都曾進入臨床開發階段，但最後都退出了。我認為，這可能部分與靶點有關。

So STEAP1 is a relatively novel target. We are in the clinic, I think, far advanced compared to anyone else. And based on the clinical data that we're seeing now, this is a program we really want to accelerate. This is another one of the programs where we will be presenting data this fall, and I'd urge you to put Xaluritamig under the radar screen and pay attention to those data. But this one, I think, has a real opportunity.

所以STEAP1是一個相對較新的標靶。我認為，我們目前的臨床試驗進展遠遠超過其他任何研究。根據我們目前掌握的臨床數據，我們非常希望能加快這個計畫的進展。今年秋季，我們將公佈該計畫的數據，我強烈建議大家關注Xaluritamig，並留意這些數據。我認為，這個計畫確實蘊藏著巨大的潛力。

Our next question comes from Colin Bristow from UBS.

下一個問題來自瑞銀集團的柯林布里斯托。

Maybe just a quick one on TEZSPIRE. You have the upcoming COPD data in the first half of '24. I was just curious as to get your expectations here? What's the threshold to suggest especially in light of the recent sort of very positive BOREAS data.

關於TEZSPIRE，我想簡單問一下。你們將在2024年上半年公佈COPD數據。我很好奇你們對此有何預期？鑑於最近BOREAS的數據非常積極，你們認為應該設定怎樣的閾值？

Yes. I think in light of what we've seen in the field, we would look to see something that is competitive with that. Just to level set everyone, the rationale for this study is that the target of TEZSPIRE and TSLP is expressed in bronchial mucosa, sputum can be detected in bronchoalveolar lavage fluid. In patients with COPD, the pathway may be a contributor or a driver of exacerbations, and that's really the hypothesis that we are testing here. So we'll look at the totality of the clinical data. But I think some of the things you've seen recently published give us benchmarks as to what we'll hope to see.

是的。我認為，鑑於我們目前在該領域的觀察，我們希望看到與之匹敵的成果。為了讓大家對概念有個清楚的了解，這項研究的理論基礎是TEZSPIRE和TSLP的標靶在支氣管黏膜中表達，痰液中可在支氣管肺泡灌洗液中檢測到。在慢性阻塞性肺病（COPD）患者中，此通路可能是導致病情惡化的因素或驅動因素，而這正是我們在此要驗證的假設。因此，我們將全面分析臨床數據。但我認為，近期發表的一些研究成果為我們指明了方向，讓我們對未來的研究方向有了更清楚的認識。

Our next question comes from Dane Leone from Raymond James.

我們的下一個問題來自 Raymond James 公司的 Dane Leone。

Maybe just two quick ones for me. Firstly, in terms of the rebound in Otezla and the good strength that seems to be coming out of some of the trialing periods for competitive products on the topical side and also oral side. Can you just maybe provide whatever response makes sense to your competitors' analysis on the oral side suggesting they've achieved over 40% TRx share? And whether you think that share could go back in favor of Otezla during the back half of this year? Or is that something you would see steady state from here on out?

我只想問兩個問題。首先，關於Otezla的反彈，以及一些競爭產品在局部用藥和口服製劑方面似乎展現出的良好勢頭。您能否就競爭對手在口服製劑方面所取得的40%以上市佔率的分析，提供一些合理的解釋？您認為Otezla的市佔率在今年下半年是否有可能重新回到Otezla手中？或者您認為市場佔有率會從此保持穩定？

And then secondly, just regarding the Phase II of tarlatamab, is there anything we need to be aware of that maybe the patient population in this Phase II small cell lung cancer study was maybe less heavier -- less heavily pretreated as opposed to what was seen in the Phase I study, which is sometimes the case.

其次，關於 tarlatamab 的 II 期臨床試驗，我們是否需要注意，這項 II 期小細胞肺癌研究中的患者群體可能體重較輕——與 I 期臨床試驗中觀察到的情況相比，其預處理程度可能較低，這種情況有時會發生。

Yes. We're taking it in 2 parts.

是的，我們分兩部分進行。

Yes. Dane, I'll attempt to answer your Otezla question. As I said, we are encouraged by what we're seeing in the market here. It's really hard for me to comment on market share claims from other companies, particularly when they're adding what we can see versus what we can't see in their free drug program. So they're giving a lot of product away.

是的，Dane，我會試著回答你關於Otezla的問題。正如我所說，我們對目前市場上的情況感到鼓舞。我很難對其他公司聲稱的市場份額發表評論，尤其是在他們把我們能看到的和看不到的免費藥物項目結合起來計算的時候。所以他們實際上是在免費贈送大量產品。

And I think they're including that in their denominator when they're providing share. I actually don't think that's going to be reflective of what their ultimate in-market performance will look like because we've seen that in many categories where free programs or bridging programs are not representative ultimately of the final access picture and the final effect that, that new access picture will have on demand.

我認為他們在提供市場份額時，已經把這部分也算進了分母裡。但我並不認為這能反映出他們最終的市場表現，因為我們已經看到，在許多領域，免費專案或過渡專案最終並不能代表最終的存取情況，也不能代表這種新的存取模式對點播業務的最終影響。

So I think that given our very good access coverage with little to no prior authorization requirements across many of those plans, we are definitely in a position should some of those free drug patients end up getting rejected for sustained actual insurance coverage because of the broad coverage we have. We have not factored that into our go forward. But it could happen.

因此，我認為，鑑於我們完善的藥品獲取管道，以及許多計劃幾乎無需事先授權，即使部分免費用藥患者最終因我們廣泛的覆蓋範圍而被拒絕提供持續的正式保險，我們也完全有能力應對。我們尚未將此因素納入未來的發展規劃，但這並非不可能。

Regarding tarlatamab, no substantive differences very heavily pretreated our population, we'll provide details this fall.

關於 tarlatamab，沒有實質差異，我們的人群接受了大量預處理，我們將在今年秋季提供詳細資訊。

Your next question comes from David Risinger from Leerink Partners.

下一個問題來自 Leerink Partners 的 David Risinger。

Could you please provide an update on your oral obesity Phase I trial and also discuss your evaluation of backup candidates?

請問您能否提供口服肥胖症 I 期試驗的最新進展，並談談您對備選候選藥物的評估？

Yes, in terms of the oral obesity program, it's moving through its Phase I, which includes single dose and short-term multiple dose. We expect probably now to have data in the first half of next year. Behind that, we have multiple programs looking at orthogonal mechanisms of action, many of them non-incretin-based, and as some of those progress towards the clinic, we'll start to talk about them and give you insights into our portfolio approach here.

是的，口服減肥藥計畫目前正在進行I期臨床試驗，包括單次給藥和短期多次給藥。我們預計明年上半年就能取得相關數據。同時，我們還有多個項目在研究不同的作用機制，其中許多並非基於腸促胰素。隨著這些項目逐步進入臨床試驗階段，我們會開始介紹它們，並向您詳細介紹我們的產品組合策略。

Julianne, why don't we take one last question as we are over a lot of time.

朱莉安娜，既然時間已經夠長了，我們不如再問最後一個問題。

Certainly, our final question will come from Robyn Karnauskas from Truist Securities.

當然，我們最後一個問題將來自 Truist Securities 的 Robyn Karnauskas。

So congratulations on tarlatamab, I'm going to call tmab, to make my life easier. But can you just opine a little bit. Usually, first -- the first innovators expand a market like small cell to be much bigger than what people think of today. And walk us through the cadence of the Phase I trials, in particular, I think the checkpoint inhibitor combination trial. Like when could we see data from that? And how do you view like even harpoon the competitive landscape and how you are differentiated from them?

恭喜你們的tarlatamab上市，為了方便起見，我就簡稱它為tmab吧。能簡單談談您的看法嗎？通常來說，先行創新者會將小細胞肺癌這樣的市場拓展到遠超過人們目前認知的規模。請您介紹I期臨床試驗的進展情況，特別是免疫檢查點抑制劑合併療法的試驗。我們什麼時候能看到相關數據？您如何看待像Harpoon這樣的競爭對手，以及您的藥物與他們的差異化優勢？

Sure. Let me start with the latter. I'm extremely enthusiastic about this molecule. As always, I'll let others talk about their molecules. But this one is one that we're really putting muscle behind. To sort of level set everyone here as you start to think about the unmet medical need, there are roughly 240,000 cases of lung cancer in the United States each year. Roughly 15% of them are small cell lung cancer, comparable numbers in Western Europe, for example. So that gives you a sense of the patient numbers. The clinical development program over time is going to be designed to look at really that broad swath of patients. Of course, we're starting in third line therapy, but our goal here is to quickly advance into the second -- into earlier lines of treatment.

當然。我先來說說後者。我對這個分子充滿熱情。像往常一樣，我會讓其他人來介紹他們的分子。但這個分子是我們真正投入大量精力研發的。為了讓大家對尚未滿足的醫療需求有個大致了解，美國每年約有24萬例肺癌病例。其中約15%是小細胞肺癌，例如西歐的情況也類似。這樣大家就能對患者數量有個大致的概念了。我們的臨床開發項目將著眼於真正涵蓋如此廣泛的患者群體。當然，我們是從三線療法入手，但我們的目標是盡快推進到二線——甚至更早期的治療領域。

And we'll talk more about those clinical studies as we get through later in the year. But this is one, again, where I think when we get into settings of lower tumor burden, as we've observed with BLINCYTO, we can really affect a natural history of the disease. Recall that upon initial diagnosis only 7% of patients with small cell lung cancer will be alive 5 years later. And that's the opportunity to change that I think is in front of us now.

今年晚些時候，我們會更詳細地討論這些臨床研究。但就目前而言，我認為，當我們進入腫瘤負荷較低的環境時（正如我們在BLINCYTO研究中觀察到的），我們確實可以影響疾病的自然病程。要知道，小細胞肺癌患者在初次診斷後，五年存活率僅7%。而這正是我認為我們現在面臨的改變現狀的機會。

Okay. Well, thank you for your question, Robyn, and thank you all for joining. As Arvind said, we know we're a couple of minutes over a lot of time, so I want to be respectful of your calendars. But I also just do want to make one more statement, if I may, which is -- before we break, I wanted to announce that after nearly 19 years in the role, Arvind Sood will be transitioning his Head of IR responsibility to our Treasurer, Justin Claeys.

好的。謝謝你的提問，Robyn，也謝謝各位的參與。正如Arvind所說，我們知道這次會議超時了幾分鐘，所以我想尊重大家的時間安排。不過，如果可以的話，我還想再補充一點——在會議結束前，我想宣布，在擔任投資者關係主管近19年後，Arvind Sood將把這一職位移交給我們的財務主管Justin Claeys。

And Arvind will remain a VP of Finance and will help Justin transition seamlessly into this new role. So -- while he's not leaving, this is nonetheless a big moment. and I wanted to acknowledge it because I know Arvind is something of a legend and a fixture in the Investor Relations world. And on a personal note, I want to just add that I've worked with Arvind now for more than 20 years.

Arvind將繼續擔任財務副總裁，並協助Justin順利過渡到新職位。所以，雖然他沒有離開，但這仍然是一個重要的時刻。我想特別提及此事，因為我知道Arvind在投資人關係領域堪稱傳奇人物，舉足輕重。另外，我個人也想補充一點，我和Arvind共事已經超過20年了。

So we began working together even before we both joined Amgen. So I want to publicly congratulate him on his accomplishments in the IR profession. And I want to, again, publicly state that I'm delighted that he's going to remain part of the finance group, working with me and Peter and the rest of the team.

所以，在我們兩個加入安進之前，我們就開始合作了。因此，我想公開祝賀他在投資者關係領域的成就。而且，我還要再次公開表示，我很高興他將繼續留在財務團隊，與我、彼得以及團隊其他成員一起工作。

So on his birthday, we have a second thing to celebrate, which is culmination of nearly 19 years in his role at Amgen. And those of you who haven't met Justin will enjoy getting to know him. He's been with Amgen for more than 20 years and served as our Treasurer for most of the past 4 years. So I know you'll all join me in wishing Justin well as he begins his transition into this role. And I know you'll all join me in wishing, Arvind, a good celebration here with us later this evening. Thank you. We'll talk to you after the next quarter.

所以，在他生日之際，我們還有另一件值得慶祝的事，那就是他在安進公司近19年的職業生涯即將圓滿結束。對於那些還不認識賈斯汀的人來說，相信你們會很樂意了解他。他已經在安進工作了20多年，並在過去四年中的大部分時間裡擔任我們的財務主管。我相信大家都會跟我一樣，祝福賈斯汀順利過渡到這個新崗位。同時，我也相信大家都會和我一樣，祝福阿文德今晚與我們一起慶祝愉快。謝謝大家。下個季度結束後，我們再見。

Great. Thank you, everybody, and we'll keep in touch.

太好了。謝謝大家，我們會保持聯絡。

This concludes our 2023 Q2 earnings call. You may now disconnect.

本次2023年第二季財報電話會議到此結束。您可以斷開連線了。