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)

我叫 Julianne，今天我將擔任安進 2023 年第二季度財務業績電話會議的會議主持人。 （操作員說明）

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

現在我想介紹投資者關係副總裁Arvind Sood。蘇德先生，您現在可以開始了。

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 (technical difficulty) growth longer term augmented by some meaningful pipeline updates, particularly with an oncology development.

謝謝你，朱麗安。大家下午好，歡迎來電討論我們第二季度的業績。本季度我們繼續沿著單位銷量強勁增長的道路前進，這導致今年剩餘時間（技術難度）增長的長期前景有所改善，並通過一些有意義的管道更新（特別是腫瘤學的發展）得到增強。

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.

我們的董事長兼首席執行官鮑勃·布拉德韋(Bob Bradway) 將主持這次電話會議並發表一些事先準備好的講話，然後領導團隊的其他成員將對我們的表現進行更廣泛的審查。您應該已經收到我們發布的幻燈片的鏈接。在我們的討論過程中，我們將做出一些前瞻性陳述，並使用非公認會計準則財務指標來描述我們的業績。只是提醒一下，實際結果可能會有很大差異。

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

因此，我想將電話轉給鮑勃。鮑勃？

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。感謝您加入我們的通話。對於安進來說，這是一個全面出色的季度，這表明我們對實現銷售和盈利長期有吸引力增長的能力仍然充滿信心。我們實現了 70 億美元的季度收入，比去年同期增長 6%，非 GAAP 每股收益創歷史新高，達到每股 5 美元，比去年同期增長 8%。本季度全球銷量增長 11%，這反映了我們所有 3 個治療領域和所有 3 個地理區域對業績的貢獻。

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 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，我們的普通醫學業務的銷量在本季度增長了 21%，而我們之前將其視為我們主要增長來源的亞太地區的銷量正處於該行業產品短缺的時期，我們的世界一流的製造能力使我們能夠滿足對產品不斷增長的需求，並延續我們每次為每位患者服務的長期傳統。

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.

我們的九種藥品在本季度創造了創紀錄的銷售額。這與我在四月份第一季度電話會議上的評論是一致的，當時我說我們看到我們目前銷售的許多產品隨著時間的推移有可能接觸到更多的患者，並為我們的長期增長做出重大貢獻。

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.

四月份，我談到了 Repatha 以及它在對抗心血管疾病方面所做出的日益增長的貢獻。今天，我要重點介紹 Prolia，它的季度銷售額首次達到 10 億美元，增長 11%。 Prolia 是初級保健醫生廣泛使用的首批生物製劑之一，用於治療慢性疾病，我們預計隨著時間的推移，這種情況將在心血管疾病等其他類別中得到復制。

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 取得了巨大的成功，但我們知道，骨質疏鬆症仍然是一種診斷不足、治療不足的疾病，使數百萬老年婦女面臨著發生改變生活的骨折的風險。根據最近生成的真實世界數據，我們確定 Prolia 在減少骨折方面優於阿崙膦酸鈉（美國最常用的雙膦酸鹽治療藥物），而且不是一點點，而是很多。

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.

給你一個數據點。今年 5 月，我們宣佈在一項真實世界研究中，Prolia 將髖部骨折的風險降低了 36%，與阿崙膦酸鈉相比，效果更佳。 Prolia和EVENITY在本季度實現了47%的銷售增長，為我們對抗骨質疏鬆帶來了強大的1-2重拳。隨著世界老齡化，這種疾病只會變得更加普遍。您很快就會從 Murdo 那裡聽到更多有關我們到 2023 年上半年非常強勁的商業表現的信息。

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.

我們也看到了我們的管道的強勁勢頭。正如您將從 Dave Reese 那裡聽到的詳細信息，我們今天將分享 BiTE tarlatamab 在小細胞肺癌中的積極數據，以及 LUMAKRAS 與 Vectibix 聯合治療結直腸癌的積極數據。我們對 tarlatamab 讀數特別興奮。不僅因為這對於預後極差的患者可能意味著什麼，還因為它讓我們更加堅信雙特異性 T 細胞接合劑是治療實體瘤和液體腫瘤的有效方法，正如我們已經證明的那樣BLINCYTO。

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.

在我們的其他產品線中，我們繼續推進幾種潛在的一流新藥的註冊試驗，包括治療心髒病的 olpasiran、治療特應性皮炎的 rocatinlimab，當然還有治療胃癌的 bemarituzumab。我們期待在今年下半年從我們的管道中獲得更多數據。

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.

談到我們對 Horizo​​n Therapeutics 的收購計劃。我們仍然非常熱衷於我們的公司能夠共同為患有罕見嚴重疾病的患者取得成就。作為一家獨立公司，Horizo​​n 確實取得了巨大的成就。安進的全球商業、製造和研發能力，尤其是生物製品方面的能力，將使 Horizo​​n 的藥物能夠比 Horizo​​n 自身更快地到達更多患者手中。如您所知，除美國聯邦貿易委員會外，這一組合已獲得世界各地監管機構的批准。聯邦貿易委員會在本案中的論點基於推測和假設性概念。他們的論點沒有建立已久的反壟斷法的基礎。

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，他們選擇追究此案，卻忽視了我們為解決他們所表達的擔憂而做出的承諾。安進 (Amgen) 和 Horizo​​n 提供的改變生活的藥物可治療不同的疾病和不同的患者群體。簡而言之，不存在競爭重疊，也沒有動機將我們的藥物與他們的藥物捆綁在一起。我們期待著九月份在法庭上提起訴訟，我相信我們會勝訴。

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?

與此同時，我們正在與 Horizo​​n 密切合作制定整合計劃，因此我們可以在 12 月中旬之前開始運作，屆時我們預計能夠完成交易。在交給默多之前，讓我再重申一點。正如第二季度所示，安進的業務表現非常出色，我們的有機增長前景強勁。 Horizo​​n 的加入將進一步增強我們的增長前景。最後，我要感謝世界各地的安進同事對患者和我們業務的堅定承諾。我們對未來以及我們為比現在更多的患者提供服務的能力感到興奮。默多？

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，鮑勃。我對我們第二季度的表現非常滿意，這得益於我們致力於履行為全球數百萬患者提供創新產品這一使命的承諾。整個業務執行力強勁，9 個品牌的季度銷售額創歷史新高，普通醫學、炎症和血液學/腫瘤學產品組合的銷量強勁增長。

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.

剔除外匯影響，第二季度全球產品銷售額同比增長8%，包含外匯影響，產品銷售額同比增長6%。我們各地區的銷量增長了 11%。美國銷量增長 9%，歐洲、拉丁美洲、中東和加拿大地區銷量增長 8%。根據我們的國際擴張戰略，亞太地區仍然是我們增長最快的地區，本季度銷量增長了 46%。

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 (inaudible) 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.

從我們的普通藥品業務開始，其中包括 Repatha、Prolia、EVENITY 和 Aimovig。在銷量增長 21% 的推動下，這 4 種產品第二季度的總體收入同比增長 19%。心血管疾病是一個日益嚴重的公共衛生危機，對3800 萬高危美國人進行的LDL 膽固醇升高（聽不清）心臟的高危ASCVD 患者的護理狀況顯示，其中只有不到30% 的患者達到了健康水平推薦的低密度脂蛋白水平。這是一個明確的行動號召，即通過 Repatha 盡可能多地、儘早地降低 LDL 膽固醇將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.

因此，為了滿足這一需求，安進致力於提高患者的獲取便利性和負擔能力。如今，我們擁有一流的 Repatha 處方覆蓋範圍，幫助 90% 符合條件的美國患者獲得這種重要藥物。改善可及性使得 Repatha 被心髒病專家廣泛採用，並越來越多地被初級保健提供者採用。因此，這為 Repatha 銷售額的增長奠定了基礎，第二季度銷售額同比增長 30%，達到創紀錄的 4.24 億美元。

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，開始治療的新患者數量創紀錄，推動了治療量增長 34%。在美國以外的地區，我們的銷量增長了 37%，勢頭強勁。我們認識到世界上還有更多的患者可以從 Repatha 中受益。為了應對這一挑戰，我們正在增加投資，加強與醫療保健提供者的接觸，通過直接面向消費者的媒體將我們的信息直接傳達給患者，並推動 LDL-C 檢測和遵守治療指南的緊迫性。

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 refracture for their osteoporosis patients.

過渡到骨骼健康。在銷量增長 11% 的推動下，Prolia 第二季度銷售額同比增長 11%，達到創紀錄的 10 億美元。正如戴夫將更詳細地討論的那樣，五月份世界骨質疏鬆症大會上提出的新的現實世界證據數據表明，與阿崙膦酸鈉相比，Prolia 顯著降低了多個終點的骨折風險。我們的銷售團隊現在配備了這些數據，並積極幫助醫生了解 Prolia 降低骨質疏鬆症患者再骨折風險的卓越能力。

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.

EVENITY 是我們 Bone 產品組合中 Prolia 的補充，在各市場銷量強勁增長的推動下，本季度銷售額達到創紀錄的 2.81 億美元。在日本，EVENITY 在不斷增長的[骨骼構建劑]市場中佔據了 42% 的份額，與競爭對手相比，性能穩步提高，並增加了初次接受治療的患者的使用情況。 EVENITY 的年銷售額目前超過 10 億美元。鑑於骨折對絕經後女性生活的嚴重影響，我們在日本取得的成功，EVENITY 的首個上市市場增強了我們對這十年巨大增長潛力的信心。

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.

在銷量增長 2% 的推動下，Otezla 銷售額同比增長 1%。 Otezla 仍然是唯一獲得批准的具有廣泛適應症的口服全身療法，並且有能力幫助超過150 萬患有輕度銀屑病的美國患者，這些患者無法通過局部治療得到最佳治療，但可以從Otezla 這樣的全身藥物中受益。

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 業務受到了新推出的局部和全身競爭對手的免費藥物計劃的影響，我們預計新患者的需求將在2023 年剩餘時間內繼續受到這些計劃的影響。儘管如此，我們仍然看到了一個令人信服的投資機會Otezla 的發展並提高醫生和患者的認識。我們對 Otezla 的增長潛力充滿信心，因為它獨特地結合了既定的功效和安全性、廣泛的付款人覆蓋範圍和有限的事先授權要求，以及缺乏啟動所需的測試，當然還有易於管理。

Enbrel sales grew each 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.

在美國第一季度價格受到季節性影響和庫存大幅減少之後，Enbrel 銷售額每個季度都在增長。在估計銷售扣除額的有利變化和更高的淨售價的推動下，Enbrel 銷售額同比增長了2%。庫存水平下降部分抵消了這一影響。儘管第二季度的治療量同比持平，但由於支付者覆蓋範圍的擴大，美國開始接受治療的新患者數量增加了 6%。在 2023 年剩餘時間內，我們預計覆蓋範圍的擴大將導致新患者數量持續增長。我們還預計全年淨售價將下降。

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 繼續保持強勁增長，第二季度銷售額達 1.33 億美元。銷售額環比增長 39%，銷量增長 37%，這得益於我們在第一季度推出經美國食品和藥物管理局批准的自行管理、預填充、一次性筆。該筆為患者提供了一種在家中使用 TEZSPIRE 的便捷選擇，這提高了可及性，並為美國所有患有嚴重不受控制的哮喘的患者提供了更靈活的治療選擇。

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.

TAVNEOS 第二季度銷售額為 3000 萬美元。由於開始治療的新患者數量增加，美國的治療量環比增長 28%。在美國，大約 2,000 名患者現已接受 1,300 多家醫療保健提供者的 TAVNEOS 治療。展望未來，安進在炎症和腎髒病學方面的豐富經驗以及龐大的市場佔有率將使我們能夠將 TAVNEOS 帶給更多 ANCA 相關血管炎患者。

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.

在銷量增長 60% 的推動下，AMJEVITA 第二季度銷售額同比增長 29%，但庫存水平和淨售價下降部分抵消了這一影響。由於為支持第一季度上市而備貨後庫存減少，美國銷售額環比下降了 63%，但銷量增長部分抵消了這一影響。

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.

轉向我們的血液學/腫瘤學業務，其中包括 LUMAKRAS、KYPROLIS、XGEVA、Vectibix、Nplate 和 BLINCYTO。強大的商業執行力和令人興奮的新臨床數據推動這 6 種創新產品的銷量同比增長 12%。繼 2022 年 12 月發布的可註冊 E1910 研究的積極數據以及 5 月份發布的更新版 NCCN 指南（積極數據和更新的指導方針支持了我們對 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.

Vectibix 第二季度銷售額同比增長 20%，得益於 III 期 PARADIGM 試驗積極數據的推動，銷量增長 20%，這證明了 Vectibix 與貝伐珠單抗聯合化療治療野生型癌症患者的優越性。 [ RAS] 型結直腸癌。

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 同比增長 9%，銷量增長 15%，但部分被淨售價下降所抵消。 LUMAKRAS 報告第二季度銷售額為 7700 萬美元，該季度銷售額與去年同期持平，20% 的銷量增長被較低的淨售價和庫存水平所抵消。我們看到了 LUMAKRAS 在新市場的推出和我們全面的全球臨床開發計劃的推動下未來的增長機會。

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.

我們整個業務的執行力很強，推動了增長並體現了我們對服務患者的奉獻精神。我們的業務表現非常高，隨著宣布收購 Horizo​​n Therapeutics，我們有潛力為更多的患者提供服務，他們可以從我們在炎症和腎髒病學領域數十年的領導地位中受益。

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

有了這個，我會把它交給戴夫·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。對於研發來說，第二季度是高質量執行的季度之一，因為我們通過兩次重要的數據讀數、多項註冊支持研究以及今年晚些時候即將推出的其他令人興奮的數據，推進了我們的創新管道。

Beginning with oncology, we are exceptionally pleased to announce positive top line results from 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.

從腫瘤學開始，我們非常高興地宣布全球II 期DeLLphi-301 試驗的積極頂線結果，該試驗評估tarlatamab，這是一種首創的DLL3 靶向BiTE 分子，用於治療2 或2 年後進展的復發性或難治性小細胞肺癌患者。更多先前的治療方案。

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 表現出客觀緩解率（主要終點），大大超過了之前 I 期研究報告的水平。療效持久且比標準護理化療的預期效果更長。與第一階段研究相比，安全性和耐受性也更加有利。這是 BiTE 特異性 T 細胞接合劑首次在常見實體瘤中顯示出明確的活性，這是該領域的一個真正的里程碑。

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. My personal thought is, 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 和其他監管機構討論這些數據，並在即將召開的醫學大會上展示這項可能註冊的 II 期研究的詳細結果。根據我們觀察到的數據，我們正在將 tarlatamab 轉移到 DeLLphi-304 的早期治療中，DeLLphi-304 是一項正在進行的 III 期研究，比較 tarlatamab 與二線小細胞肺癌的標準護理化療。我們還計劃啟動另外兩項 tarlatamab 在小細胞肺癌早期治療中的 III 期研究。我個人的想法是，我相信這個分子可以帶來變革，並且迫不及待地想與該領域分享這些數據。

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 FDI 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.

轉向盧馬克拉斯。我們繼續執行我們的綜合臨床計劃，旨在生成了解 KRAS 生物學以及 LUMAKRAS 在非小細胞肺癌、結直腸癌和其他實體瘤中所發揮的作用所需的廣泛數據。我們很高興地宣布，評估 LUMAKRAS 聯合 Vectibix 治療化療難治性轉移性 KRAS G12C 突變結直腸癌的全球 III 期 CodeBreaK 300 試驗在 240 毫克和 960 毫克劑量下均達到了無進展生存期的主要終點。在可比劑量下，功效結果與之前在此環境中觀察到的結果一致，沒有新的安全信號。我們期待與全球衛生當局分享這些結果，並在即將召開的醫學大會上展示詳細結果。 FDI 最近授予 LUMAKRAS 與 Vectibix 聯合療法突破性療法稱號，用於治療經 FDA 批准的測試確定的轉移性 KRAS G12C 突變結直腸癌患者，這些患者根據之前的 CodeBreaK 101 研究的數據已接受過化療。

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，我們還繼續探索新的組合，力求將 LUMAKRAS 推向一線。最近公佈的 SCARLET 研究數據為在 PD-L1 陰性腫瘤的一線非小細胞肺癌患者中啟動 LUMAKRAS 聯合化療 III 期試驗提供了依據，而聯合 Vectibix 和化療的 Ib 期數據支持啟動LUMAKRAS 與Vectibix 和FOLFIRI 治療一線G12C 突變結直腸癌的III 期研究。

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.

6月，FDA批准了BLINCYTO的補充生物製劑許可申請，用於治療首次或第二次完全緩解且微小殘留病大於或等於0.1%的CD19陽性B細胞前體急性淋巴細胞白血病成人和兒童患者。此次批准將 BLINCYTO 的加速批准轉變為完全批准。

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 的全球監管提交工作正在順利進行，E1910 是一項由美國國家癌症研究所、東部合作腫瘤學組和美國放射學會成像網絡癌症研究組進行的III 期試驗，該試驗證明，與鞏固化療相比，BLINCYTO 治療聯合鞏固化療具有更高的總體生存率。對新診斷的費城陰性 ALL 成年患者進行護理鞏固化療，這些患者在誘導和強化化療後呈 MRD 陰性。

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.

《國家綜合癌症網絡 B 細胞 ALL 腫瘤學臨床實踐指南》進行了三項重要更新。其中包括將 BLINCYTO E1910 方案列為費城陰性成年患者一線治療的唯一首選方案，將 BLINCYTO 添加到多藥化療中作為 MRD 陰性疾病的鞏固治療。最後，將 BLINCYTO 與酪氨酸激酶抑製劑聯合應用納入 MRD 陰性費城陽性疾病治療方案的首位。

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.

最後，4 月，《新英格蘭醫學雜誌》上發表的數據表明，與歷史數據相比，BLINCYTO 聯合化療可提高 KMT2A 重排 B-ALL 嬰兒的 2 年生存率。 BLINCYTO 的 2 年生存率為 93%，而單獨化療的 2 年生存率為 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.

如果您查看全部數據，很明顯 BLINCYTO 正在改變 B 細胞 ALL 的治療範例。在疾病晚期、疾病早期、年輕患者和老年患者中。我們對其未來的潛力仍然感到興奮，並致力於在早期治療中進一步研究 BLINCYTO，並通過皮下給藥提高患者的便利性。

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.

作為第一個 BiTE，BLINCYTO 還為 tarlatamab 等分子的開發提供了路線圖，這些分子在腫瘤負荷較低的情況下可能具有增強的活性。另外兩個值得關注的早期腫瘤學項目是 Xaluritamig 和 AMG 193。Xaluritamig 是一種一流的 STEAP1 靶向雙特異性藥物，正在晚期前列腺癌中進行研究，其中 STEAP1 幾乎在所有腫瘤細胞上表達。我們正在觀察該分子的顯著抗腫瘤活性，並正在迅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 提供了雙特異性 T 細胞接合劑的另一個例子，在實體瘤環境中表現出活性。 AMG 193 是一種一流的小分子 MTA 協同 PRMT5 抑製劑，正在晚期 MTAP 無效實體瘤患者中進行研究。在沒有 MTAP 的情況下 PRMT5 的過度表達會導致 MTA 的積累，我們在 AMG 193 的獨特設計中利用了這種生物學特性，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.

該通路的改變發生在大約 15% 的實體瘤中，通常與不良預後相關，並且歷史上很難[藥物]。我們目前正在參與 AMG 193 的 Ib/II 期研究，雖然還處於早期階段，但我們對在多種腫瘤類型中觀察到的抗腫瘤反應感到鼓舞。我們期待今年秋天分享 Xaluritamig 和 AMG 193 的數據。

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.

在普通醫學領域，我們正在推進我們的心血管專營權和新興的肥胖分子產品組合，重點是臨床試驗的執行。 Olpasiran 是我們針對動脈粥樣硬化性心血管疾病中的小干擾RNA 分子的潛在同類最佳Lp(a) 的III 期結果研究正在順利入組，而maridebart cafraglutide（以前稱為AMG 133）在肥胖症患者中的II 期研究也正在順利入組。或沒有糖尿病和相關合併症。 II 期研究的目標是生成數據，為設計 III 期計劃提供廣泛的選擇，利用 maridebart cafraglutide 的獨特特性，實現強勁、可持續的減肥效果。

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.

如前所述，5 月份，我們提供了一項對美國醫療保險計劃中近50 萬患有骨質疏鬆症的絕經後婦女進行的真實世界研究的數據，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，同一項研究還表明，較長時間的 Prolia 治療與主要骨質疏鬆性骨折風險的更大降低有關。這些數據充分證明了 Prolia 在治療絕經後骨質疏鬆症方面的重要性，以及利用真實世界證據研究大量患者群體治療效果的能力。

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.

在炎症方面，除了嚴重哮喘之外，我們正在研究 TEZSPIRE 的多種其他適應症，包括針對慢性鼻竇炎伴鼻息肉和嗜酸粒細胞性食管炎的單獨 III 期研究。我們還有 2 項 II 期研究，其中一項針對慢性自發性蕁麻疹，另一項針對慢性阻塞性肺病。科羅拉多州立大學的研究已完成，預計即將發布頂線數據。 COPD 試驗已全部入組，並招募了廣泛的 COPD 患者，包括嗜酸性粒細胞計數高和低的患者。我們期待在 2024 年上半年公佈這項研究。

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.

Rocatinlimab 是一種一流的抗 OX40 單克隆抗體，正在中度至重度特應性皮炎患者中進行研究。 ROCKET III 期臨床開發計劃的招募工作已經有了一個良好的開端。我們還計劃在中度至重度不受控制的哮喘中啟動一項 II 期研究，同時探索 rocatinlimab 的這一附加適應症。為了完善臨床總結，我們繼續按時、按預算執行我們的生物仿製藥產品組合，包括最近啟動的一項關鍵研究，評估ABP 206 與OPDIVO 的藥代動力學相似性，OPDIVO 是6 種計劃的新生物仿製藥中的一種。

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，我想強調一下我們最近宣布的與 TScan Therapeutics 的合作。這是一項多年合作，將使用 TScan 專有的靶點發現平台 TargetScan 來識別克羅恩病患者 T 細胞識別的抗原，並代表一種研究這種難以治療的疾病的新方法。我要感謝世界各地的安進員工在我們努力滿足我們所服務的患者的需求時對執行的不懈關注。

I'll now turn it over to Peter.

我現在把它交給彼得。

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.

謝謝你，戴夫。我們對第二季度強勁的業績感到滿意，銷量增長了 11%，研發投資增加，非 GAAP 每股收益同比增長 8%。這增強了我們實現 2023 年目標的信心，並使我們有能力實現或超越我們的長期承諾。在討論我們的 2023 年指導之前，我將回顧一下我們的第二季度業績。需要提醒的是，這些業績和前景反映的是安進的獨立業績，沒有對已宣布的 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.

轉向幻燈片 41 所示的第二季度財務業績，總收入為 70 億美元，同比增長 6%，是安進歷史上最高的季度收入。產品銷售額同比增長8%，總收入同比增長7%，剔除匯率的負面影響。第二季度非公認會計原則運營支出總額同比增長 7%。我們投資並推進了我們的產品線，並加速了我們優先營銷產品的增長，同時實現了非 GAAP 營業利潤率（佔產品銷售額的 52.6%），體現了費用紀律。

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.

本季度非 GAAP 研發支出同比增長 7%，反映出在後期項目和上市產品支持支出增加的推動下，我們的管道投資不斷增長。非 GAAP 銷售成本佔產品銷售額的百分比同比增長 2.4 個百分點，達到 17.1%，這主要是由於利潤份額增加和產品組合變化所致。

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.

第二季度非 GAAP SG&A 費用同比下降 6%。我們繼續專注於我們的持續改進運營模式，優先考慮投資、數字化和提高生產力，以及在其他情況下，繼續我們歷史上已經開始在人工智能的許多用途中執行的任務。第二季度非 GAAP 其他收入和支出淨支出為 3.07 億美元。這種同比的好感度主要是由於北京會計從權益法改為按市值投資的變化所推動的，其影響僅包含在我們的公認會計原則結果中。正如預期，我們第二季度的非公認會計準則稅率增加了 1.7 個百分點，達到 16.4%，這主要是由於 2022 年波多黎各稅法變更，從 2023 年開始用所得稅取代了消費稅。

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.

我們繼續執行我們的資本配置優先事項。首先，我們繼續對最佳創新（包括內部創新和外部創新）進行優先投資。在第二季度，我們推動了 AMG 133 和 olpasiran 等後期項目的支出增加，以及對我們已上市產品（包括 TAVNEOS）的支持。其次，我們繼續投資我們的業務。由於我們在俄亥俄州和北卡羅來納州同時建設最先進的製造設施，資本支出接近峰值水平。

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並獲得許可，我們的年度資本支出將從 2024 年開始下降，未來幾年資本支出將開始恢復到接近歷史水平。第三，我們計劃繼續向股東返還資本。我們第二季度支付了每股 2.13 美元的股息，比 2022 年第二季度增長了 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%.

該公司在2023 年第二季度產生了38 億美元的自由現金流，而2022 年第二季度為17 億美元，這主要是由於納稅時間的推動，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將出現強勁的現金流，這與我們的 2023 年全年財務展望一致，其中包括約 50% 的非公認會計原則營業利潤率。

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.

現在轉向幻燈片 43 上的 2023 年業務前景。我們的指導目前針對安進獨立業務提供，不包括任何地平線預測。由於 Horizo​​n 交易預計將於 12 月中旬完成，Horizo​​n 產生的貢獻將在此期間之後包含在內。鑑於我們的強勁表現，我們將 2023 年收入指導上調至 266 億至 274 億美元，而之前的指導為 262 億至 273 億美元。儘管我們的業績讓我們有信心提高全年指引，但我們預計第三季度的銷售額可能會低於第二季度，因為醫療保險甜甜圈洞的影響在下半年更為明顯，而且第二季度預計銷售扣除額發生了一些有利的變化。

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.

關於我們的非公認會計原則每股收益指導，鑑於我們業務和管道的加速發展，我們打算利用優勢增加對內部創新和優先營銷產品的投資。為了反映我們改善的收入前景以及我們的投資計劃，我們將非 GAAP 每股收益指導修改為 17.80 美元至 18.80 美元，而之前的指導為 17.60 美元至 18.70 美元。同樣，儘管我們的業績讓我們有信心提高全年非公認會計原則每股收益，但由於預期的第三季度銷售和我們對業務的投資，我們預計第三季度非公認會計原則每股收益將低於第二季度。

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.

在對 2023 年剩餘時間進行建模時需要考慮的其他重要要點。我們現在預計 Neulasta 全年銷售額約為 8 億美元，KANJINTI 和 MVASI 全年合計銷售額約為 9 億美元。我們現在預計 2023 年的其他收入將在 11 億美元至 13 億美元之間，而之前的範圍為 12 億美元至 15 億美元。請注意，我們2022 年第三季度的業績包括與我們的新冠抗體製造協議相關的約9000 萬美元的其他收入，以及我們所獲得的里程碑，但我們預計不會在2023 年第三季度重複這一里程碑。

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 運營費用將比去年增長近 3%，而我們之前的預測為增長 1%，原因是預計銷量增加、額外投資推動我們的創新渠道和增加支持，導致銷售成本上升用於我們日益增長的優先營銷產品，包括Repatha 和Otezla。我們仍然預計 2023 年全年營業利潤率佔產品銷售額的百分比約為 50%，儘管剩餘兩個季度的每個季度都會有所不同。

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.

我們仍然預計非 GAAP 銷售成本佔產品銷售額的百分比將在 16% 至 17% 之間。我們現在預計 2023 年的非 GAAP 研發費用將同比增長約 5%，高於我們之前 3% 至 4% 的指導。我們繼續預計非公認會計準則銷售、管理及行政費用 (SG&A) 支出佔產品銷售額的百分比將同比略有下降。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]範圍內，低於之前指導的 12 億美元至 13 億美元。

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.

對於全年，我們預計非 GAAP 稅率為 17.5% 至 18.5%，低於之前指導的 18.0% 至 19.0%。我們預計第三季度的稅率將接近修訂後範圍的上限17.5%至18.5%。我們的 2023 年資本支出指引保持在約 9.25 億美元不變。我們對安進的長期前景和長期增長充滿信心。我們期待在12 月中旬之前完成宣布的對Horizo​​n 的收購，正如鮑勃所指出的，我非常感謝我們的24,000 多名同事在第二季度及以後成功地履行了我們為患者提供服務的使命。

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

財務更新到此結束。我會將其轉交給鮑勃進行問答。

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。現在我們將為呼叫者開放線路，以便他們可以提問，我會請我們的接線員提醒您這樣做的程序。

(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?

恭喜本季度。也許有一個關於 OX40 的問題。人們對 OX40 的安全性存在一些擔憂，就像人們對自身免疫現象的擔憂一樣，我正在閱讀一些文獻並表明，在 OX40（缺乏 OX40）動物模型中，干擾素-γ 會受到損害。那麼，只是想了解您如何管理這種特定藥物的風險？它是如何產生自身免疫現象的？這是一個令人擔憂的問題嗎？

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.

這是戴夫。所以我們知道這些對話。我可以告訴你的是，讓我分兩部分來回答你的問題。其一，從機制上講，OX40 主要在特應性皮炎的活化 T 細胞和活化致病性 T 細胞上表達。在二期項目中，我們沒有觀察到自身免疫現象。顯然，這是我們正在追踪的事情，但目前我們沒有臨床信號或跡象表明此類擔憂。

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，您關於乾擾素γ的問題也意味著風險，例如感染風險。在第二階段項目中，我們在接受治療的患者中也沒有看到比安慰劑更高的情況。這些是我們將遵循的事情。幾乎所有細胞因子抑制計劃都會定期遵循它們。但到目前為止，我們還沒有收到信號。

Our next question comes from Michael Yee from Jefferies.

我們的下一個問題來自 Jefferies 的 Michael Yee。

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.

鮑勃評論了對 Horizo​​n 交易的熱情。我知道總的來說，TED 市場的銷售存在很多不確定性。您能否描述一下您對 TED 市場的持續信心、您對此感到興奮的原因以及您對重新發展這項業務的信心？您是否參與過討論，或者至少了解當前的動態，或者至少與公司就 TED 市場進行持續對話。

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。我分兩部分來回答。也許我一會兒會把它交給默多。但讓我重申一下，我們仍然非常興奮。當然，我們正在仔細觀察市場的發展，並在適當的時候與 Horizo​​n 的朋友討論這一點。再次，基於我們對臨床數據的看法、對國際機遇以及擴大產品範圍的能力的看法，我們對我們可以在那裡做的事情感到非常興奮。但是默多，你為什麼不進一步詳細說明呢？

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，我們看到美國 Horizo​​n 團隊的強大執行力，並且這裡有幾個增長的催化劑。他們已經擴大了商業足跡，因此應該開始受到關注。他們現在擁有低 CAS 患者群體的數據，該試驗在公共領域的積極結果尚未公佈，但已在公共領域提供並交給他們的銷售人員。所以這是最近的事，不一定反映在他們的歷史表現中。

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.

鮑勃提到了國際市場的推出。我們仍然相信，交易結束後，我們將能夠幫助加快那裡正在進行的工作。我們還看到在新歷年之前發布了一些改進的醫療政策。因此，我應該說，看到付款人改善或取消對較低 CAS 患者群體使用 TEPEZZA 的限制是非常令人鼓舞的。

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，有很多良好的催化劑，我認為 Horizo​​n 系統地釋放了這些額外的增長機會，我們仍然非常看好 TEPEZZA 在大量甲狀腺眼病患者中的效用，根據臨床數據，他們將從該治療中受益。我在TEPEZZA 上要提到的最後一件事是，他們也能夠在OPTIC-J 中復制低CAS 群體結果- 在他們的OPTIC-J 試驗中，抱歉，他們不是低CAS，而是甲狀腺眼的註冊數據疾病和 OPTIC-J。因此，這為它們未來在日本的潛在推出奠定了良好的基礎。

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.

因此，非常好的數據流、非常好的執行和投資以及重點。看看，除了 TEPEZZA 之外，我們還對他們的另外 2 個大型同線品牌（KRYSTEXXA 和 UPLIZNA）感到非常興奮。因此，總的來說，我們仍然感到興奮並相信，兩家公司在這個真正強大的產品組合上的合作將是一個很好的組合。

Our next question comes from Salveen Richter from Goldman Sachs.

我們的下一個問題來自高盛的 Salveen Richter。

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.

您能否為我們介紹tarlatamab 在小細胞肺癌中的二期臨床數據，並分享有關該概況的更多詳細信息，特別是，與您確認的客觀緩解率為1 期的一期數據相比，該數據有何不同？ 23%，中位緩解持續時間為 13 個月。我想你已經註意到它大大超過了第一階段的結果。

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，薩爾文，謝謝你的提問。對這個分子非常非常興奮。如果您退後一步，我認為這代表了我們希望在BiTE 平台中看到的內容以及在主要實體瘤中的實質性臨床效果，將數據放在與我們的I 期相比的背景中。如上所述，我們大大超過了23我們在第一階段報告的響應率百分比。我們計劃在秋季會議上展示這些數據。當然，我無法提供更多細節。但我可以告訴你，我對緩解率數據、緩解持續時間和總體生存率感到非常滿意。

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.

就背景而言，在三線小細胞肺癌患者中，緩解率通常遠低於 50%。但重要的是，在大多數情況下，它們都非常短暫，通常只有幾週或幾個月。因此，根據我們所觀察到的情況，我認為我們確實有機會改變這種疾病的自然史，特別是當我們邁向早期治療時，應增強 BiTE 在較低腫瘤疾病負擔環境中的活性正如我們在BLINCYTO 中觀察到的那樣。因此，我們現在所有的努力都集中在執行早期的生產線試驗上。因此，我認為，這是我們前進過程中需要關注的一個問題，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，你想對這裡的安全說些什麼嗎，顯然……

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.

在安全性方面，我認為我們在開發計劃中學到了很多有關臨床管理的知識。原則上，我們對細胞因子釋放綜合徵等副作用的發生率感到非常滿意，我們也期待在今年秋天提供數據時分享這些細節，但對耐受性和安全性也非常滿意。

Next question comes from Jay Olson from Oppenheimer.

下一個問題來自奧本海默的傑伊·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?

祝賀本季度，特別是 tarlatamab 和 LUMAKRAS 結果，祝 Arvind 生日快樂。對於結直腸癌的LUMAKRAS 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機會？

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。就這而言——這顯然是一個較小的患者群體，大約 4% 的結直腸癌含有 G12C 突變。就下一步而言，我們計劃與 FDA 和其他監管機構就這些 III 期數據進行討論。隨著這些對話的展開，我將提供有關潛在監管途徑的指導。然後正如我提到的，根據這些數據和 Ib 期數據的強度，在一線環境中使用 Vectibix 化療、LUMAKRAS 組合。我們還在推進一線疾病的 III 期試驗。所以我認為結直腸癌的治療也正在全力推進。再次，當我們進行適當的對話時，我將提供有關後續步驟的指導。

Our next question comes from Chris Raymond from Piper Sandler.

我們的下一個問題來自 Piper Sandler 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 也向 Arvind 致以熱烈的生日祝福。只是一個關於 AMJEVITA 的問題。很明顯，當你們第一次談論這個機會時，美國的採用可能並不是最初考慮的那樣。但也許有幾個問題。您能否首先談談高價 SKU 和低價 SKU 之間的腳本劃分？

And then second, maybe there's been a lot of talk around what AbbView 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，也許迄今為止，關於 AbbView 為削弱生物仿製藥的採用所做的事情已經有很多討論。就他們所做的事情而言，最讓你們感到驚訝的是什麼（如果有的話）？未來的計劃是什麼？

Sure. Will you take that, Murdo?

當然。你願意接受嗎，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，我們在 AMJEVITA 的生物仿製藥市場仍處於早期階段，鑑於如此大的產品具有生物仿製藥競爭，我們清楚地看到了新的付款行為。

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 pair 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.

就高與低而言，我們是——這是一種不同的組合。我們看到的主要是 PBM 利用率較高，而 IDN 利用率較低，其中低成本——低淨成本對他們很有吸引力。但同樣，現在還為時過早，我認為這 2 個 SKU 之間的產品組合尚未確定。我還想說，我們仍在等待，看看進入 2024 年的下一個配對談判週期會發生什麼。正如您所看到的，許多 PBM 都公開表示，他們在以下方面還沒有做很多工作：到2023年推動生物仿製藥的利用，但計劃在2024 年做更多的事情。所以我認為這裡還有很多事情要做。

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.

就艾伯維的戰略而言，我們在創新方面與他們競爭，現在我們用我們的生物仿製藥與他們競爭，我們也了解他們的做法。所以沒有太多驚喜。但我認為，對於我們、其他生物仿製藥製造商和其他觀察者來說，藥品效益如何與生物仿製藥的吸收或缺乏相結合的情況已經變得越來越清楚。因此還有更多內容需要關注。

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，從長遠來看，我們仍然對生物仿製藥的增長感到非常興奮。正如 Dave 提到的，我們繼續致力於研究投資，開發更多生物仿製藥，最近推出了 ABP 206，這是一種 OPDIVO 的生物仿製藥。我們還在繼續考慮在美國的醫療福利報銷系統中推出其他生物仿製藥，這顯然是我們在之前推出的 KANJINTI 和 MVASI 中取得成功的地方。

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，我們的生物仿製藥的大部分增長將來自前美國和美國醫療福利生物仿製藥，我們仍然相信我們將能夠產生強勁的增長，此前我們曾表示，我們將把2021 年的銷售額增加一倍以上，大約為20億美元。

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?

所以恭喜所有的數據。我的問題是，3.5 個月是之前數據中的 PFS，我認為這是 20% 以上的響應率。從你描述這一變革的方式來看。可以說在 [DLL3] 研究中 PFS 也得到了有意義的改善嗎？

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，回到地平線交易，我覺得有兩件事是明確的。你對這筆交易非常忠誠，但這也取決於至少到目前為止，你的表現嚴重不足，而投資者提出的問題是，有沒有辦法重新協商購買價格？

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。 Umer，我可以說的是，我對療效包、總體緩解率、無進展生存期、緩解持續時間和總體生存期非常滿意，而無需透露具體的禁運人數，我們將在即將召開的醫學大會上展示所有這些數據。但對我來說，這是一個非常非常引人注目的功效包。

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。在 Horizo​​n 上，Umer，你是對的，我們仍然熱衷於在我們宣布的交易基礎上繼續推進。我至少會提出問題——我們的觀點與你的問題中隱含的觀點不同，但我們會留到另一天再討論。

Our next question comes from Yaron Werber from TD Cowen.

我們的下一個問題來自 TD Cowen 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?

我有一個關於 Otezla 的問題，也與 Enbrel 有關。具體來說，Enbrel 有所反彈，這是很高興看到的，考慮到 AMJEVITA 和仿製藥 Humira，這確實是您所實施的合同的淨收益。不過，Otezla（聽不清）實際上在吸收方面做得相當不錯。它有一個良性的標籤，顯然還有一個藥物項目。是什麼讓您對未來的前景充滿信心？

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.

謝謝亞龍的提問。你是對的。 Enbrel 確實有一個強勁的季度業績，坦率地說，我們受益於我們在 Enbrel 上獲得的最佳訪問權限，我們現在已經涵蓋了所有主要的 PBM。因此，我們看到 Enbrel 的新患者增長非常好。因此，越來越多的新患者開始接受 Enbrel 治療，我們認為，這將支持全年持續的治療量。為此，我們確實放棄了一些價格。所以這也流經 Enbrel。

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該類別中的生物仿製藥活動在某種程度上影響了Enbrel，上個季度我很清楚，這不是我們所看到的，現在在第二季度已經很清楚了Humira 生物仿製藥的競爭不會對 Enbrel 產生負面影響。所以我們——我們看到 Enbrel 未來的穩定性。

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 most 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.

對於奧特茲拉來說，我們實際上看到了奧特茲拉的一些實力。我們對新患者獲取情況感到滿意。我們認為我們可以做得更好。正如我在準備好的發言中提到的，我們將在今年年底對 Otezla 進行更多投資，彼得也提到了這一點。我們樂觀的原因是我們在幫助那些最熱門的第一系統患者方面正在獲得動力。這裡的 Epi 非常重要。在美國，有 150 萬此類患者堅持局部治療，而最好採用全身藥物進行治療，而 Otezla 確實是全身藥物的理想選擇。

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.

我們與 Otezla 擁有廣泛的商業覆蓋，幾乎不需要事先授權。我們沒有啟動測試要求，而且自付費用的承受能力非常好。因此，Otezla 對於 PBM 和付款人來說是一個有吸引力的選擇，可以維持其處方集。對於皮膚科醫生來說，這是一個簡單的選擇，作為他們為停止局部用藥並接受治療的患者選擇的第一種全身藥物。再說一次，這種較溫和的疾病形式，沒有其他人從系統角度為輕度人群提供指示。所以總體來說，這篇論文還是不錯的。

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 進入市場顯然給我們帶來了壓力，有些患者可能正在接受我們的口服治療，但他們的牛皮癬症狀沒有完全解決，他們會轉而使用 Sotyktu。我們看到的是，速度已經放緩。在我們目前 Otezla 的患者組合中，我們輸給 Sotyktu 的人數較少，我們認為今年上半年給我們帶來壓力的另一個動力是局部治療也有免費商品計劃，他們正在接受審判，而且這種情況已經減弱。他們變平了。

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，我們從外用藥獲得的壓力越來越小，患者從 Otezla 轉移到 Sotyktu 的次數也減少了。因此，我認為我們確實必須了解 24 年新型藥物的獲取途徑將如何演變，但我們對目前的獲取途徑以及目前對 Otezla 的安全性和有效性的看法非常有信心，我們可以進一步滲透到該人群患者。因此，展望未來，我們對此感覺良好。

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

我們的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（Gregory Renza）。

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?

偉大的。恭喜本季度。鮑勃，我們當然感謝您在監管機構和法院面前為 Horizo​​n 交易辯護。也許只是為了建立在你所闡述的信念之上。我只是想問一下您對生物製藥價值創造生態系統潛在負面結果的影響以及安進等公司向患者提供藥品的能力的看法。因此，如果我們只是稱其為捆綁銷售等新穎的法律理論確實盛行。那會產生什麼影響呢？也許對此，您和安進團隊真的會採取多大程度的努力來保留完成交易的機會？

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.

好吧，我想我會重申我在準備好的發言中所說的話，對吧，那就是我們不相信他們的案件是基於任何既定的反壟斷法。我們認為它是基於假設和推測的概念。我們期待有機會在法庭上主張這一點。

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.

再次，我們希望在法庭上獲勝。我認為你的問題隱含著這樣一種認識：我們生活在一個非常分散的行業，並且有很多創新者特別強調，這使得他們很難充分利用其創新潛力，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 Horizo​​n 這樣的公司帶來價值方面發揮作用。我們已經反复討論過這個問題，但我們認為我們的全球商業組織的能力，我們在此類產品的製造、研發方面所展示的專業知識，我認為將使我們能夠接觸到比公司更多的患者自己就能做到。

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，這個行業能夠利用美國大部分生物技術公司存在的創新生態系統而蓬勃發展。再次，我們預計這種情況將繼續下去，我認為，如果公司不可能聯合起來從彼此的優勢中受益，結果將是更少的創新到達更少的患者。所以這將是一個不幸的結果。

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.

也許有一個適合你，戴夫。您能否詳細闡述針對前列腺癌中 STEAP1 與 PSMA 的生物學原理？我是在今天從競爭對手那裡得到的更新的背景下提出這個問題的，他們的 PSMA 計劃與你們的不同，由於安全問題，他們必須進行重大修改。

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，埃文。我們有幾個以 STEAP1 為目標的理由。 #1，它幾乎在晚期癌細胞中普遍表達。正常組織不存在廣泛的高水平表達，因此您可以利用雙特異性 T 細胞接合劑產生我們一直在尋找的治療窗口。 PSMA 一直是一個具有挑戰性的目標。該目標似乎具有獨特的屬性。我想你也知道，多種分子，包括我們自己的一些分子，已經進入臨床開發階段，然後又退出臨床開發階段。我開始相信，這可能部分與目標相關。

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是一個相對新穎的靶點。我認為，我們在診所裡比其他任何人都先進得多。根據我們現在看到的臨床數據，這是我們真正想要加速的計劃。這是我們今年秋天將展示數據的另一個項目，我敦促您將 Xaluritamig 放在雷達屏幕下並註意這些數據。但我認為，這確實是一個機會。

Our next question comes from Colin Bristow from UBS.

我們的下一個問題來自瑞銀集團的科林·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.

也許只是在 TEZSPIRE 上快速介紹一下。您將獲得 24 年上半年的 COPD 數據。我只是好奇在這裡得到你的期望？特別是考慮到最近非常積極的 BOREAS 數據，建議的門檻是多少。

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，根據我們在該領域所看到的情況，我們希望看到與之競爭的東西。給大家科普一下，本研究的理由是TEZSPIRE和TSLP的靶點在支氣管粘膜中表達，痰液中可以在支氣管肺泡灌洗液中檢測到。在慢性阻塞性肺病患者中，該通路可能是病情加重的一個促成因素或驅動因素，這確實是我們在這裡測試的假設。因此，我們將查看全部臨床數據。但我認為您最近發布的一些內容為我們希望看到的內容提供了基準。

Our next question comes from Dane Leone from Raymond James.

我們的下一個問題來自 Raymond James 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?

也許對我來說只有兩個快速的。首先，就 Otezla 的反彈以及似乎來自外用和口服競爭產品的一些試用期的良好實力而言。您能否提供對競爭對手口頭分析有意義的任何回應，表明他們已經實現了超過 40% 的 TRx 份額？您是否認為今年下半年 Otezla 的份額可能會回升？或者從現在開始你會看到穩定的狀態嗎？

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，就 tarlatamab 的 II 期而言，我們是否需要注意什麼，也許這項 II 期小細胞肺癌研究中的患者群體可能不那麼重——與所看到的情況相比，預處理程度較低在第一階段研究中，有時會出現這種情況。

Yes. We're taking it in 2 parts.

是的。我們將其分為兩部分。

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。戴恩，我將嘗試回答你的奧特茲拉問題。正如我所說，我們對這里市場的情況感到鼓舞。我真的很難評論其他公司的市場份額聲明，特別是當他們在免費藥品計劃中添加我們可以看到的內容和我們看不到的內容時。所以他們贈送了很多產品。

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.

我認為他們在提供份額時將其納入分母中。實際上，我認為這不會反映他們最終的市場表現，因為我們已經看到，在許多類別中，免費程序或橋接程序最終不能代表最終的訪問情況和最終效果也就是說，新的訪問圖片將按需提供。

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，鑑於我們非常好的准入覆蓋範圍，其中許多計劃幾乎沒有或沒有事先授權要求，如果其中一些免費藥物患者最終因覆蓋範圍廣泛而被拒絕獲得持續的實際保險覆蓋，我們絕對處於有利地位我們有。我們還沒有將其納入我們的前進計劃中。但這有可能發生。

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

關於 tarlatamab，我們的人群沒有受到嚴重預處理的實質性差異，我們將在今年秋天提供詳細信息。

Your next question comes from David Risinger from Leerink Partners.

您的下一個問題來自 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?

您能否提供有關口腔肥胖 I 期試驗的最新信息，並討論一下您對後備候選藥物的評估？

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，就口腔肥胖計劃而言，它正在進入第一階段，其中包括單劑量和短期多劑量。我們現在預計可能會在明年上半年獲得數據。在此背後，我們有多個項目著眼於正交作用機制，其中許多項目不是基於腸促胰素的，隨著其中一些項目向臨床取得進展，我們將開始討論它們，並讓您深入了解我們的投資組合方法。 。

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

朱麗安，我們為什麼不回答最後一個問題，因為我們已經討論了很多時間了。

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

當然，我們的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?

所以恭喜 tarlatamab，我要打電話給 tmab，讓我的生活更輕鬆。但你能稍微發表一下意見嗎？通常，首先，第一批創新者將小蜂窩等市場擴大到比人們今天想像的要大得多。並引導我們了解第一階段試驗的節奏，特別是我認為檢查點抑製劑組合試驗。比如我們什麼時候可以看到數據？您如何看待競爭格局以及您如何與他們區分開來？

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。讓我從後者開始。我對這個分子非常感興趣。一如既往，我會讓其他人談論他們的分子。但這是我們真正投入精力的一項。當你開始考慮未滿足的醫療需求時，請大家先了解一下，美國每年大約有 240,000 例肺癌病例。其中大約 15% 是小細胞肺癌，例如西歐的數字相當。這樣您就可以了解患者數量。隨著時間的推移，臨床開發計劃將旨在真正關注廣大患者。當然，我們正在從三線治療開始，但我們的目標是快速進入第二線——早期的治療。

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.

我們將在今年晚些時候完成更多關於這些臨床研究的討論。但我認為，正如我們在 BLINCYTO 中觀察到的那樣，當我們進入較低腫瘤負荷的環境時，我們確實可以影響疾病的自然史。回想一下，初次診斷後，只有 7% 的小細胞肺癌患者在 5 年後仍能存活。我認為現在擺在我們面前的是改變的機會。

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。好吧，羅賓，謝謝你的提問，也感謝大家的加入。正如阿爾文德所說，我們知道很多時間都只有幾分鐘，所以我想尊重你們的日曆。但如果可以的話，我還想再發表一項聲明，那就是——在我們分手之前，我想宣布，在擔任該職務近19 年後，Arvind Sood 將把他的IR 主管職責移交給我們的財務主管，賈斯汀·克萊斯。

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，並將幫助 Justin 無縫過渡到這一新角色。所以——雖然他不會離開，但這仍然是一個重要的時刻。我想承認這一點，因為我知道阿溫德是投資者關係界的傳奇人物和固定人物。就我個人而言，我想補充一點，我已經與 Arvind 合作了 20 多年。

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.

因此，我們在加入安進之前就開始合作。因此，我想公開祝賀他在投資者關係專業領域取得的成就。我想再次公開表示，我很高興他將繼續留在財務團隊，與我、彼得以及團隊的其他成員一起工作。

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.

因此，在他生日那天，我們還有第二件事要慶祝，這是他在安進近 19 年來的工作的頂峰。那些沒有見過賈斯汀的人會很高興認識他。他在安進工作了 20 多年，過去 4 年大部分時間擔任我們的財務主管。所以我知道你們都會和我一起祝愿賈斯汀在開始過渡到這個角色時一切順利。我知道你們都會和我一起祝愿阿爾文德今晚晚些時候與我們一起慶祝。謝謝。我們將在下個季度後與您交談。

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

偉大的。謝謝大家，我們會保持聯繫。

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

我們的 2023 年第二季度財報電話會議到此結束。您現在可以斷開連接。