美國安進 (AMGN) 2023 Q1 法說會逐字稿

內容摘要

Amgen 報告稱,2023 年第一季度單位銷量增長強勁,10 個品牌的銷售額創歷史新高,美國和國際市場也出現增長。

該公司的研發投資增長了 12%,並提供了其管線進展的最新信息,包括 TEZSPIRE 的多項 III 期研究和 rocatinlimab 的 ROCKET III 期臨床開發計劃的招募。

Amgen 致力於其資本分配優先事項,包括投資於內部和外部創新,投資於其業務以進一步實現長期增長,以及向股東返還資本。

該公司已將其 2023 年收入指引上調至 262 億美元至 273 億美元,並將其非 GAAP 每股收益指引上調至每股 17.60 美元至 18.70 美元。

安進對其宣布收購 Horizon 持樂觀態度,並對將安進的能力和全球影響力帶入 Horizon 一流創新藥物組合及其產品線的潛力感到興奮。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • My name is Julie Anne, and I will be your conference facilitator today for Amgen's First Quarter Full Year 2023 Financial Results Conference Call. (Operator Instructions)

    我叫朱莉安妮,今天我將擔任安進 2023 年第一季度全年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.

    我現在想介紹投資者關係副總裁 Arvind Sood。 Sood 先生,您現在可以開始了。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Thank you, Julie Anne. Good afternoon, everyone, and welcome to our call to discuss our results for the first quarter of 2023.

    謝謝你,朱莉·安妮。大家下午好,歡迎來電討論我們 2023 年第一季度的業績。

  • Strong unit volume growth that sets up the stage nicely for improved outlook for the balance of the year, these are some of the key themes that you're going to hear about today.

    強勁的單位銷量增長為改善今年餘下的前景奠定了良好的基礎,這些是您今天將要聽到的一些關鍵主題。

  • 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 have posted.

    我們的董事長兼首席執行官鮑勃·布拉德威 (Bob Bradway) 將主持電話會議並發表一些事先準備好的講話,然後由我們領導團隊的其他成員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。

  • Through the course of our discussion today, 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.

    在我們今天的討論過程中,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業績,並提醒您實際結果可能存在重大差異。

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

    因此,我想將電話轉給 Bob。鮑勃?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Thank you, Arvind, and let me thank all of you for joining our call. I'll begin by calling your attention to the 14% volume growth we delivered in the first quarter that illustrates 2 points worth keeping in mind when thinking about the remainder of the year and beyond.

    好的。謝謝 Arvind,也讓我感謝大家加入我們的電話會議。首先,我將提請您注意我們在第一季度實現的 14% 的銷量增長,這說明了在考慮今年剩餘時間及以後的時間時值得牢記的兩點。

  • First, on the COVID front, we seemed to have finally turned the page on the pandemic in terms of its impact on the overall health care system. For example, we've seen year-over-year prescription growth across most specialties in the U.S., including cardiology and oncology. And that's good news because it suggests that patients are returning to their pre-pandemic routines, with doctor visits once again enabling appropriate diagnoses and treatments. It's obviously something that bodes well for our portfolio of medicines.

    首先,在 COVID 方面,就其對整個醫療保健系統的影響而言,我們似乎終於翻開了這一流行病的一頁。例如,我們已經看到美國大多數專科的處方藥逐年增長,包括心髒病學和腫瘤學。這是個好消息,因為它表明患者正在恢復大流行前的常規,醫生的就診再次能夠進行適當的診斷和治療。這顯然預示著我們的藥物組合。

  • Second, we're seeing that the demand for medicines is resilient despite the current macroeconomic challenges. Repatha, EVENITY, BLINCYTO and KYPROLIS, for example, all delivered record sales in the quarter driven by extremely strong growth in volumes of 33%, 55%, 49% and 18%, respectively. We don't see this volume-driven, rather we see this as the potential for these medicines and others in our portfolio to reach many more patients over time and contribute substantially to our long-term growth.

    其次,我們看到儘管當前面臨宏觀經濟挑戰,但對藥品的需求仍具有彈性。例如,Repatha、EVENITY、BLINCYTO 和 KYPROLIS 在銷量分別增長 33%、55%、49% 和 18% 的強勁增長的推動下,本季度均實現了創紀錄的銷售額。我們不認為這是數量驅動的,而是我們認為這是這些藥物和我們產品組合中的其他藥物隨著時間的推移惠及更多患者並為我們的長期增長做出重大貢獻的潛力。

  • Take Repatha. We believe there's tremendous upside opportunity for Repatha at a time when most high-risk cardiovascular patients still never reach their recommended LDL levels or do so only for a brief insufficient period of time. The global public health crisis and heart disease demands that all players in the system work together to drive change. And with Repatha, we have a proven innovation that we know can be an essential part of the solution.

    以 Repatha 為例。我們認為,在大多數高危心血管患者仍未達到推薦的低密度脂蛋白水平或僅在短時間內達到這一水平的情況下,Repatha 存在巨大的上漲機會。全球公共衛生危機和心髒病要求系統中的所有參與者共同努力推動變革。通過 Repatha,我們擁有一項經過驗證的創新,我們知道它可以成為解決方案的重要組成部分。

  • Two of our newest medicines, TEZSPIRE and TAVNEOS, achieved quarter-over-quarter volume growth in the U.S. of 28% and 27%, respectively. TEZSPIRE has enjoyed strong adoption in the U.S. by both allergists and pulmonologists and a recently approved prefilled pen gives patients the option for self-administration. A few quarters into our ownership of TAVNEOS, we're convinced that our deep experience in rheumatology and nephrology will enable us to bring this first-in-class medicine to many more patients who can benefit from it.

    我們的兩種最新藥物 TEZSPIRE 和 TAVNEOS 在美國的銷量環比分別增長了 28% 和 27%。 TEZSPIRE 在美國已被過敏症專家和肺病專家廣泛採用,最近批准的預填充筆讓患者可以選擇自行給藥。在我們擁有 TAVNEOS 幾個季度後,我們相信,我們在風濕病學和腎髒病學方面的豐富經驗將使我們能夠將這種一流的藥物帶給更多可以從中受益的患者。

  • Outside the U.S., volumes grew more than 20% in the quarter. In the Asia Pacific region, in particular, we generated nearly 50% volume growth as we expand the number of patients we serve in Japan and China, 2 of the world's most rapidly aging nations, with medicines like Repatha and Prolia.

    在美國以外,本季度銷量增長超過 20%。特別是在亞太地區,隨著我們在日本和中國這兩個世界上老齡化速度最快的國家使用 Repatha 和 Prolia 等藥物服務的患者數量增加,我們實現了近 50% 的銷量增長。

  • Amgen's R&D investment was up 12% in the quarter. That growth reflects the investments we are making in registration-enabling trials for several potential new first-in-class medicines including olpasiran in heart disease, rocatinlimab in inflammation and bemarituzumab and tarlatamab in cancer. All 4 of these medicines are quintessentially Amgen. They're innovative molecules that deliver large effect sizes against serious diseases for which new treatments are very much needed.

    安進的研發投資在本季度增長了 12%。這一增長反映了我們正在對幾種潛在的一流新藥的註冊試驗進行投資,包括治療心髒病的 olpasiran、治療炎症的 rocatinlimab 以及治療癌症的 bemarituzumab 和 tarlatamab。所有這 4 種藥物都是典型的 Amgen。它們是創新分子,可以對嚴重疾病產生巨大的影響,而這些疾病非常需要新的治療方法。

  • We are pursuing a number of significant new indications for TEZSPIRE, BLINCYTO and LUMAKRAS as well. We look forward to several data readouts from our pipeline, mainly in the second half of the year.

    我們也在為 TEZSPIRE、BLINCYTO 和 LUMAKRAS 尋求一些重要的新適應症。我們期待從我們的管道中讀取幾個數據,主要是在今年下半年。

  • We continue to invest heavily in early research where we've built a differentiated set of capabilities over the past decade that position us well to take advantage of the rapid convergence of biology and technology that we see happening today.

    我們繼續大力投資早期研究,在過去十年中我們建立了一套差異化的能力,使我們能夠很好地利用我們今天看到的生物學和技術的快速融合。

  • At a time when the world marvels at ChatGPT, we've been deploying artificial intelligence and machine learning in our research labs for some time now, giving us dry lab capabilities that, when applied to biologics development, have already yielded improved success rates and reduced cycle times beyond our initial expectations. This is indeed an exciting time for biologic innovation.

    在世界驚嘆 ChatGPT 的時候,我們已經在我們的研究實驗室中部署人工智能和機器學習一段時間了,為我們提供幹實驗室能力,當應用於生物製劑開發時,已經提高了成功率並減少了週期時間超出了我們最初的預期。這確實是生物創新的激動人心的時刻。

  • We remain optimistic about our announced acquisition of Horizon. And similar to our experience with TAVNEOS, the more time we've spent with the team at Horizon, the more excited we become about the potential to bring Amgen's capabilities and global presence to bear on Horizon's portfolio of first-in-class innovative medicines and its pipeline.

    我們對宣布收購 Horizon 保持樂觀。與我們在 TAVNEOS 上的經歷類似,我們與 Horizon 團隊在一起的時間越長,我們就越有可能將 Amgen 的能力和全球影響力用於 Horizon 的一流創新藥物組合和它的管道。

  • It's an exciting time for all of us at Amgen, and the demand for innovative medicines has proven to be resilient and growing around the world at the same time that our ability to innovate has never been greater.

    這對我們安進的所有人來說都是一個激動人心的時刻,事實證明,對創新藥物的需求在全球範圍內具有彈性並不斷增長,與此同時,我們的創新能力也從未如此強大。

  • Always, I'm grateful to my Amgen colleagues around the world for their commitment to patients and to our business.

    我始終感謝我在世界各地的 Amgen 同事,感謝他們對患者和我們業務的承諾。

  • Now let me turn it over to Murdo.

    現在讓我把它交給默多。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks, Bob. We kicked off 2023 with strong execution of our mission to bring innovative products to millions of patients globally. We saw record sales for 10 brands in the first quarter with strong volume gains across our general medicine and hematology-oncology growth brands, our inflammation therapeutic launch of AMJEVITA and the growth of TEZSPIRE and TAVNEOS. And our announced acquisition of Horizon Therapeutics will soon add several important medicines to our portfolio.

    謝謝,鮑勃。 2023 年我們以強有力的執行使命拉開序幕,為全球數百萬患者提供創新產品。我們在第一季度看到 10 個品牌的銷售額創下歷史新高,我們的普通醫學和血液腫瘤學增長品牌的銷量增長強勁,我們的 AMJEVITA 炎症治療藥物上市以及 TEZSPIRE 和 TAVNEOS 的增長。我們宣布的對 Horizon Therapeutics 的收購將很快在我們的產品組合中增加幾種重要的藥物。

  • Volume growth in the first quarter was 14%, with 10% growth in the U.S. and 22% growth outside the U.S. Asia Pacific continues to be our fastest-growing region with 47% volume growth in the quarter. Excluding the impact of foreign exchange, first quarter global product sales grew 4%. Including the 2% negative foreign exchange impact, product sales increased 2% year-over-year.

    第一季度銷量增長 14%,其中美國增長 10%,美國以外地區增長 22%。亞太地區繼續成為我們增長最快的地區,本季度銷量增長 47%。剔除外匯影響,第一季度全球產品銷售額增長 4%。包括 2% 的負面外匯影響,產品銷售額同比增長 2%。

  • Starting with our General Medicine business, which includes Repatha, Prolia, EVENITY and Aimovig. Overall revenue for these 4 products grew 13% year-over-year in the first quarter driven by 19% volume growth. Cardiovascular disease is a growing crisis.

    從我們的普通醫學業務開始,其中包括 Repatha、Prolia、EVENITY 和 Aimovig。在銷量增長 19% 的推動下,第一季度這 4 種產品的總收入同比增長 13%。心血管疾病是一個日益嚴重的危機。

  • In the U.S., someone has a heart attack every 40 seconds -- per heart attack or stroke. However, the state of care for high-risk ASCVD patients with elevated LDL-cholesterol is shockingly poor. However, we have recently released -- from the FH Foundation of 38 million high-risk Americans showing that fewer than 30% of them ever reached their recommended LDL levels. These statistics emphasize the importance of therapies like Repatha to address a significant medical need.

    在美國,每 40 秒就有一個人心髒病發作——每次心髒病發作或中風。然而,低密度脂蛋白膽固醇升高的高危 ASCVD 患者的護理狀況非常差。然而,我們最近發布了來自 FH 基金會的 3800 萬高風險美國人的數據,顯示其中只有不到 30% 的人達到了推薦的低密度脂蛋白水平。這些統計數據強調了像 Repatha 這樣的療法對於解決重大醫療需求的重要性。

  • And we're pleased that more and more patients are now benefiting from Repatha. And with volume growth of 33% in the first quarter, leading to an increase in sales of 18%, price erosion also slowed in the first quarter and declined less than prior year. In the U.S., volume growth of 32% was driven by broad adoption of Repatha by cardiologists and increasing adoption by primary care providers. Outside the U.S., we saw a 34% volume growth, with strong momentum across our international business.

    我們很高興越來越多的患者現在受益於 Repatha。隨著第一季度銷量增長 33%,導致銷售額增長 18%,第一季度價格侵蝕也有所放緩,降幅低於去年同期。在美國,32% 的銷量增長是由心髒病專家廣泛採用 Repatha 以及初級保健提供者越來越多地採用所推動的。在美國以外,我們的銷量增長了 34%,我們的國際業務勢頭強勁。

  • There's clearly more work to be done to address this cardiovascular health crisis. This March, at the American College of Cardiology, we convened the first ever annual LDL-C Action Summit to address the state of cardiovascular care in the U.S. by identifying strategies and delivering solutions to improve lipid management among the highest-risk ASCVD patients. By intensifying the focus on lowering LDL-C, a coalition of leading stakeholders in cardiovascular care have come together with Amgen to unite on a bold goal. By 2030, our ambition is to halve the number of cardiovascular events in the U.S. We are confident that Repatha will play an important role in achieving this ambition.

    要解決這一心血管健康危機,顯然還有更多工作要做。今年 3 月,在美國心髒病學會,我們召開了有史以來第一次年度 LDL-C 行動峰會,通過確定策略和提供解決方案來改善最高風險 ASCVD 患者的脂質管理,以解決美國心血管護理的現狀。通過加強對降低低密度脂蛋白膽固醇 (LDL-C) 的關注,心血管護理領域的主要利益相關者聯盟與安進 (Amgen) 攜手合作,共同實現一個大膽的目標。到 2030 年,我們的目標是將美國的心血管事件數量減半。我們相信 Repatha 將在實現這一目標方面發揮重要作用。

  • Transitioning to bone health. Prolia sales grew 9% year-over-year for the first quarter driven by 8% volume growth. EVENITY, which complements Prolia in our bone portfolio, had record sales of $254 million for the quarter primarily driven by strong volume growth across markets.

    過渡到骨骼健康。在銷量增長 8% 的推動下,Prolia 第一季度銷售額同比增長 9%。 EVENITY 在我們的骨骼產品組合中對 Prolia 進行了補充,本季度銷售額達到創紀錄的 2.54 億美元,這主要是由於各個市場銷量的強勁增長。

  • Now to our inflammation portfolio. Otezla volume increased 5% in the quarter. Sales decreased 13% year-over-year driven by lower inventory levels and price declines resulting from patient and payer mix. Additional rebates were also provided to improve the quality of coverage. Growth of 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 impacted by these programs throughout 2023.

    現在到我們的炎症組合。本季度 Otezla 的銷量增長了 5%。由於庫存水平下降以及患者和付款人組合導致的價格下降,銷售額同比下降 13%。還提供了額外的回扣以提高覆蓋質量。我們美國 Otezla 業務的增長受到針對新推出的局部和全身競爭對手的免費藥物計劃的影響,我們預計新的患者需求將在整個 2023 年繼續受到這些計劃的影響。

  • Longer term, we see strong growth potential for Otezla given its established efficacy and safety profile, strong payer coverage with limited prior authorization requirements and ease of administration. 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 and can benefit from a systemic treatment like Otezla.

    從長遠來看,我們認為 Otezla 具有強大的增長潛力,因為其既定的療效和安全性、強大的付款人覆蓋範圍以及有限的事先授權要求和易於管理。 Otezla 仍然是唯一獲批的具有廣泛適應症的口服全身治療藥物,可以很好地幫助超過 150 萬美國未接受過全身治療的輕度銀屑病患者,這些患者無法通過局部治療得到最佳解決,並且可以從像 Otezla 這樣的全身治療中獲益。

  • Enbrel volumes in the U.S. increased 1% in the quarter supported by improved payer coverage. Several important factors to consider when reflecting on Enbrel performance in the quarter: global sales decreased 33% year-over-year driven by declines in net selling price, lower inventory levels compared to previous years and the 9% unfavorable impact of changes to estimated sales deductions related to prior periods. Going forward, we expect low single-digit volume growth throughout 2023, lower year-over-year declines in net selling price and a gradual recovery in inventory levels.

    Enbrel 在美國的銷量在本季度增長了 1%,這得益於付款人覆蓋率的提高。反映本季度 Enbrel 業績時需要考慮的幾個重要因素:全球銷售額同比下降 33%,原因是淨售價下降、與往年相比庫存水平較低以及估計銷售額變化 9% 的不利影響與前期相關的扣除。展望未來,我們預計整個 2023 年銷量將保持低個位數增長,淨售價同比降幅將減少,庫存水平將逐步恢復。

  • The TEZSPIRE launch is progressing well with $96 million in sales in the first quarter driven by strong adoption in the U.S. by allergists and pulmonologists. TEZSPIRE's unique differentiated profile offers broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma without any phenotypic and biomarker limitations. During the first quarter, the U.S. Food and Drug Administration approved TEZSPIRE for self-administration in a prefilled single-use pen, which offers patients the convenient option to administer TEZSPIRE at home. This improves accessibility and provides more flexibility in treatment options for all patients in the United States.

    TEZSPIRE 的推出進展順利,第一季度的銷售額為 9600 萬美元,這得益於美國過敏症專家和肺病專家的大力採用。 TEZSPIRE 獨特的差異化特徵為治療全球 250 萬嚴重未控制哮喘患者提供了廣闊的潛力,而沒有任何表型和生物標誌物限制。在第一季度,美國食品和藥物管理局批准 TEZSPIRE 在預填充的一次性筆中進行自我管理,這為患者提供了在家中使用 TEZSPIRE 的便捷選擇。這提高了可及性,並為美國所有患者提供了更大的治療選擇靈活性。

  • Sales of TAVNEOS were $23 million in the first quarter. U.S. volumes grew 27% quarter-over-quarter driven by an increase in new patients starting treatment. In the U.S., TAVNEOS has now been prescribed to over 1,700 patients, confirming our belief that Amgen's deep experience in inflammation and nephrology and substantial market presence allows us to bring TAVNEOS to more patients with ANCA-associated vasculitis.

    TAVNEOS 第一季度的銷售額為 2300 萬美元。在開始治療的新患者增加的推動下,美國銷量環比增長 27%。在美國,TAVNEOS 現已為超過 1,700 名患者開出處方,這證實了我們的信念,即安進在炎症和腎髒病學方面的豐富經驗以及大量的市場佔有率使我們能夠將 TAVNEOS 帶給更多 ANCA 相關血管炎患者。

  • In the first quarter, AMJEVITA launched as the first U.S. biosimilar to Humira, a medicine used by more than 1 million patients living with serious inflammatory diseases. We saw the first prescriptions to patients being fulfilled this quarter, and we're encouraged by the high awareness of AMJEVITA among gastroenterologists and rheumatologists. With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to treat patients with this biosimilar medicine. Looking ahead, we expect Q2 AMJEVITA sales in the U.S. to be lower than Q1 sales as the majority of our U.S. AMJEVITA sales in the first quarter stemmed from inventory build.

    第一季度,AMJEVITA 作為美國首個 Humira 生物仿製藥上市,該藥物被超過 100 萬患有嚴重炎症性疾病的患者使用。我們在本季度看到了第一批為患者開具的處方,我們對胃腸病學家和風濕病學家對 AMJEVITA 的高度認識感到鼓舞。憑藉我們在開發和製造生物製劑方面的業績記錄以及數十年的炎症治療經驗,安進擁有獨特的能力來使用這種生物仿製藥治療患者。展望未來,我們預計美國第二季度 AMJEVITA 銷售額將低於第一季度銷售額,因為我們第一季度美國 AMJEVITA 銷售額的大部分來自庫存增加。

  • Moving to our hematology and oncology business, which includes LUMAKRAS, KYPROLIS, XGEVA, Vectibix, Nplate and BLINCYTO. Sales and volume for these 6 innovative products grew 21% year-over-year for the quarter, with KYPROLIS and BLINCYTO achieving record quarterly sales. Growth in our hematology and oncology business was supported by important new clinical data. BLINCYTO sales grew 41% in the first quarter supported by strong adoption across academic and community centers, following positive data from the registration-enabling E1910 study presented in December of 2022.

    轉向我們的血液學和腫瘤學業務,其中包括 LUMAKRAS、KYPROLIS、XGEVA、Vectibix、Nplate 和 BLINCYTO。本季度這 6 種創新產品的銷售額和銷量同比增長 21%,其中 KYPROLIS 和 BLINCYTO 實現了創紀錄的季度銷售額。我們的血液學和腫瘤學業務的增長得到了重要的新臨床數據的支持。 BLINCYTO 銷售額在第一季度增長了 41%,這得益於學術和社區中心的大力採用,這是繼 2022 年 12 月公佈的支持註冊的 E1910 研究的積極數據之後。

  • Vectibix sales increased 16% year-over-year for the first quarter driven by 15% volume growth, supported by positive data from the Phase III PARADIGM trial, demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy. KYPROLIS continued its strong trajectory with 25% growth in the quarter driven by 18% volume growth.

    在 III 期 PARADIGM 試驗的積極數據的支持下,第一季度 Vectibix 銷售額同比增長 16%,銷量增長 15%,證明 Vectibix 優於貝伐珠單抗聯合化療。 KYPROLIS 繼續保持強勁勢頭,本季度增長 25%,銷量增長 18%。

  • LUMAKRAS reported $74 million in sales in the first quarter and a 19% increase year-over-year driven by 40% volume growth, partially offset by lower net selling price. Outside the U.S., LUMAKRAS has been approved in 50 countries, and we're actively launching in over 30 markets and pursuing reimbursement in the remaining countries.

    LUMAKRAS 第一季度銷售額為 7400 萬美元,同比增長 19%,銷量增長 40%,部分被較低的淨售價所抵消。在美國以外,LUMAKRAS 已在 50 個國家/地區獲得批准,我們正在 30 多個市場積極推出並在其餘國家/地區尋求報銷。

  • Sales of our oncology biosimilars declined 27% year-over-year in the first quarter driven by lower net selling price. While our biosimilars for MVASI and KANJINTI, both hold leading shares in the U.S., we expect continued net selling price deterioration and accelerating volume declines driven by increased competition. Over time, we expect long-term growth in our biosimilars business to be driven by the addition of new molecules and additional launches.

    由於淨售價下降,第一季度我們的腫瘤生物仿製藥銷售額同比下降 27%。雖然我們的 MVASI 和 KANJINTI 生物仿製藥都在美國占據領先地位,但我們預計淨售價將持續惡化,並且由於競爭加劇,銷量將加速下滑。隨著時間的推移,我們預計我們的生物仿製藥業務的長期增長將受到新分子的添加和更多發布的推動。

  • Given the strong performance of our hematology-oncology portfolio and the recent positive data on BLINCYTO and Vectibix, as well as ongoing clinical development of LUMAKRAS in our oncology pipeline, I look forward to the future growth potential of this portfolio.

    鑑於我們血液學-腫瘤學產品組合的強勁表現和近期關於 BLINCYTO 和 Vectibix 的積極數據,以及我們腫瘤產品線中 LUMAKRAS 的持續臨床開發,我期待該產品組合未來的增長潛力。

  • As we close out this first quarter 2023, I'm pleased with our strong execution across our portfolio both in the U.S. and internationally.

    在我們結束 2023 年第一季度時,我對我們在美國和國際上的投資組合的強勁執行感到滿意。

  • And with that, I'll turn it to Dave.

    有了這個,我會把它交給戴夫。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Thanks, Murdo, and good afternoon, everyone. For R&D, last quarter was one of high-quality execution as we progressed our innovative pipeline with multiple registration-enabling studies on track. In general medicine, we advanced our cardiovascular franchise and emerging portfolio of obesity molecules with a focus on clinical execution.

    謝謝,默多,大家下午好。對於研發,上個季度是高質量的執行之一,因為我們通過多項註冊支持研究推進了創新管道。在普通醫學方面,我們推進了我們的心血管專營權和新興的肥胖分子產品組合,重點是臨床執行。

  • Let's start with olpasiran. Phase III outcome study in atherosclerotic cardiovascular disease is enrolling well. In March, we presented additional data demonstrating that olpasiran markedly reduced Lp(a) concentration irrespective of baseline levels in individuals with atherosclerotic cardiovascular disease and Lp(a) that was greater than 150 nanomoles per liter.

    讓我們從 olpasiran 開始。動脈粥樣硬化性心血管疾病的 III 期結果研究招募順利。 3 月,我們提供了額外的數據,證明 olpasiran 顯著降低了 Lp(a) 濃度,而不管患有動脈粥樣硬化性心血管疾病和 Lp(a) 大於 150 納摩爾/升的個體的基線水平如何。

  • We also initiated the African American Heart Study in collaboration with the Association of Black Cardiologists and the Morehouse School of Medicine. This study will measure the association between Lp(a) and atherosclerotic cardiovascular disease in 5,000 African-American individuals. African-Americans show a higher average Lp(a) concentration than white individuals, but Lp(a) research to date has primarily been conducted in those of European descent. We are collaborating on the African American Heart Study to bridge this gap.

    我們還與黑人心髒病專家協會和莫爾豪斯醫學院合作發起了非裔美國人心臟研究。這項研究將測量 5,000 名非洲裔美國人的 Lp(a) 與動脈粥樣硬化性心血管疾病之間的關聯。非裔美國人的平均 Lp(a) 濃度高於白人,但迄今為止,Lp(a) 研究主要是在歐洲血統的人群中進行的。我們正在合作開展非裔美國人心臟研究,以彌合這一差距。

  • Turning to obesity. We are rapidly enrolling a Phase II study of AMG 133 in patients with obesity with or without diabetes and related comorbidities. The study will investigate different dosing levels and regimens, with the overall goal of generating data that will provide broad optionality to design a Phase III program that will deliver strong, sustainable weight loss.

    轉向肥胖。我們正在迅速招募 AMG 133 的 II 期研究,用於患有或不患有糖尿病及相關合併症的肥胖患者。該研究將調查不同的劑量水平和方案,其總體目標是生成數據,這些數據將為設計 III 期計劃提供廣泛的選擇性,從而實現強勁、可持續的減肥效果。

  • A Phase I trial of AMG 786, a small molecule targeting non-incretin pathways in obesity, is enrolling patients. Multiple preclinical molecules, all with different mechanisms of action than GLP-1 or GIPR-based therapies are also advancing towards the clinic.

    AMG 786 的 I 期試驗正在招募患者,AMG 786 是一種針對肥胖症非腸促胰島素途徑的小分子。多種臨床前分子,都具有與 GLP-1 或基於 GIPR 的療法不同的作用機制,也正在向臨床推進。

  • 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, one in chronic spontaneous urticaria and the other in COPD. The CSU study is complete with top line data anticipated in mid-2023.

    在嚴重哮喘以外的炎症方面,我們正在研究 TEZSPIRE 的多種其他適應症,包括針對伴有鼻息肉的慢性鼻竇炎和嗜酸性粒細胞性食管炎的單獨 III 期研究。我們還有 2 項 II 期研究,一項針對慢性自發性蕁麻疹,另一項針對 COPD。 CSU 研究已完成,預計將在 2023 年年中提供頂線數據。

  • The COPD trial is fully enrolled and has recruited a broad population of COPD patients, including patients with both high and low eosinophil counts. Emerging evidence suggests that TSLP is involved in chronic inflammatory disorders, including COPD, and that TSLP may be a key driver of the severe exacerbations experienced by COPD patients. We look forward to the readout of this study in the first half of 2024.

    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。新出現的證據表明,TSLP 參與慢性炎症性疾病,包括 COPD,並且 TSLP 可能是 COPD 患者經歷的嚴重惡化的關鍵驅動因素。我們期待在 2024 年上半年讀出這項研究。

  • For rocatinlimab, potentially 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. This program is a suite of 7 studies that will establish safety and efficacy in a broad population of patients with atopic dermatitis, including biologic-naive, biologic- or JAK-experienced, diverse ethnic groups and adolescents. We're also testing different dosing regimens, including the potential for monthly or less frequent dosing.

    對於 rocatinlimab,可能是一流的抗 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已經開始。該項目由 7 項研究組成,將在廣泛的特應性皮炎患者群體中確定安全性和有效性,包括未接受過生物製劑治療、具有生物製劑或 JAK 治療經驗的不同種族群體和青少年。我們還在測試不同的給藥方案,包括每月或更低頻率給藥的可能性。

  • We're encouraged to see Horizon report on the statistically significant and clinically meaningful top line results from a Phase IV clinical trial of TEPEZZA. As revised FDA label states, TEPEZZA is indicated for the treatment of thyroid eye disease regardless of clinical activity score or disease duration. Phase IIb studies in systemic lupus erythematosis of rozibafusp alfa and efavaleukin alfa were stopped for futility. These studies utilized novel adaptive designs, which enabled us to generate decision-making data more quickly and cost-effectively.

    我們很高興看到 Horizon 報告了 TEPEZZA 的 IV 期臨床試驗的統計顯著性和臨床意義的頂線結果。正如修訂後的 FDA 標籤所述,無論臨床活動評分或疾病持續時間如何,TEPEZZA 均適用於治療甲狀腺眼病。 rozibafusp alfa 和 efavaleukin alfa 在系統性紅斑狼瘡中的 IIb 期研究因無效而停止。這些研究採用新穎的自適應設計,使我們能夠更快、更經濟地生成決策數據。

  • SLE remains a challenging area for drug development, one that will be an area of focus for us as we further explore these data sets to advance our knowledge in the field. In addition to our organic pipeline, we look forward to incorporating the Horizon molecules upon deal close to further enhance our efforts to address inflammatory disease.

    SLE 仍然是藥物開發的一個具有挑戰性的領域,隨著我們進一步探索這些數據集以增進我們在該領域的知識,這將是我們關注的一個領域。除了我們的有機管道外,我們還期待在交易完成後納入 Horizon 分子,以進一步加強我們解決炎症性疾病的努力。

  • In oncology, global regulatory submissions are planned in the second half of 2023 for E1910 and a Phase III trial led by the ECOG ACRIN cooperative group, demonstrating that addition of BLINCYTO to standard-of-care consolidation chemotherapy significantly increased overall survival versus standard-of-care in MRD-negative adult patients with newly diagnosed B-cell ALL. Beyond this study, we are investing to move BLINCYTO into earlier lines of treatment and to improve patient convenience through subcutaneous administration.

    在腫瘤學方面,計劃在 2023 年下半年針對 E1910 和 ECOG ACRIN 合作小組領導的 III 期試驗提交全球監管申請,證明將 BLINCYTO 添加到標準治療鞏固化療中可顯著提高總體生存率與標準治療相比- 新診斷 B 細胞 ALL 的 MRD 陰性成年患者的護理。除了這項研究,我們正在投資將 BLINCYTO 轉移到更早的治療線,並通過皮下給藥提高患者的便利性。

  • DeLLphi-304, a Phase III study comparing tarlatamab site molecule targeting DLL3 with standard-of-care chemotherapy in second-line small-cell lung cancer will be initiated this month. We will have top line from a potentially registrational Phase II study of tarlatamab in heavily pretreated patients with small-cell lung cancer in the second half of 2023, a potential milestone for patients with small-cell lung cancer.

    DeLLphi-304是一項 III 期研究,將在二線小細胞肺癌中比較靶向 DLL3 的 tarlatamab 位點分子與標準護理化療。我們將在 2023 年下半年對經過大量預處理的小細胞肺癌患者進行 tarlatamab 的潛在註冊 II 期研究,獲得頂線,這對小細胞肺癌患者來說是一個潛在的里程碑。

  • As you are aware, we are exploring novel combinations with LUMAKRAS. Phase III study of LUMAKRAS in combination with Vectibix in third-line colorectal cancer is fully enrolled with data readout anticipated in the second half of 2023. We plan to initiate a Phase III study of LUMAKRAS and chemotherapy in first-line non-small-cell lung cancer in PD-L1 negative patients.

    如您所知,我們正在探索與 LUMAKRAS 的新穎組合。 LUMAKRAS 聯合 Vectibix 治療三線結直腸癌的 III 期研究已全部入組,預計將於 2023 年下半年公佈數據。我們計劃啟動 LUMAKRAS 和化療在一線非小細胞治療中的 III 期研究PD-L1 陰性患者的肺癌。

  • At ASCO, data will be presented from studies of LUMAKRAS in combination with standard-of-care chemotherapy in non-small-cell lung cancer and in combination with Vectibix and standard-of-care chemotherapy in colorectal cancer. We also completed submission of the LUMAKRAS CodeBreak 200 data, along with data from the Phase II dose comparison substudy, to the U.S. FDA and to the European Medicines Agency, or EMA.

    在 ASCO 上,將展示 LUMAKRAS 與非小細胞肺癌標準護理化療相結合以及與 Vectibix 和結直腸癌標準護理化療相結合的研究數據。我們還完成了向美國 FDA 和歐洲藥品管理局 (EMA) 提交 LUMAKRAS CodeBreak 200 數據以及來自 II 期劑量比較子研究的數據。

  • For AMG 509, a STEAP1 targeting bispecific, now named xaluritamig, we have determined target doses and open monotherapy expansion cohorts in patients with advanced prostate cancer. We look forward to sharing initial data in the second half of 2023.

    對於 AMG 509,一種靶向 STEAP1 的雙特異性藥物,現在命名為 xaluritamig,我們已經確定了晚期前列腺癌患者的目標劑量和開放的單藥治療擴展隊列。我們期待在 2023 年下半年共享初始數據。

  • To add to our growing biosimilars portfolio, we are pleased to announce that the European Commission granted marketing authorization for BEKEMV, our biosimilar to SOLIRIS. BEKEMV is the first biosimilar to SOLIRIS approved by the EC and is approved only for the treatment of adults and children with paroxysmal nocturnal hemoglobinuria, or PNH, a rare life-threatening bone marrow disorder. We have also submitted the U.S. Biologics License Application to the FDA for this product.

    為了增加我們不斷增長的生物仿製藥產品組合,我們很高興地宣布,歐盟委員會授予了我們的 SOLIRIS 生物仿製藥 BEKEMV 的營銷許可。 BEKEMV 是第一個獲得 EC 批准的 SOLIRIS 生物仿製藥,僅被批准用於治療患有陣發性睡眠性血紅蛋白尿症或 PNH 的成人和兒童,這是一種罕見的危及生命的骨髓疾病。我們還向 FDA 提交了該產品的美國生物製品許可申請。

  • Additionally, a Phase III switching study to support an interchangeability designation in the U.S. using an investigational high-concentration formulation of AMJEVITA met its primary end point of similarity for the primary pharmacokinetics end points.

    此外,一項 III 期轉換研究支持美國的互換性指定,使用 AMJEVITA 的研究高濃度製劑達到了主要藥代動力學終點相似性的主要終點。

  • In conclusion, I would 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,我要感謝世界各地的安進員工在我們努力滿足所服務患者的需求時不懈地專注於執行。

  • I'll now turn things over to Peter.

    我現在把事情交給彼得。

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • Thank you, Dave. We're pleased with our execution and remain on track to deliver against our full year 2023 and longer-term objectives driven again by strong 14% volume growth across a number of products, including Repatha, EVENITY, BLINCYTO, TEZSPIRE and TAVNEOS. While we advance our late-stage pipeline and work to complete the acquisition of Horizon by the end of June, we continue to invest for long-term growth.

    謝謝你,戴夫。我們對我們的執行感到滿意,並繼續按計劃實現我們的 2023 年全年目標和長期目標,這再次受到包括 Repatha 、 EVENITY 、 BLINCYTO 、 TEZSPIRE 和 TAVNEOS 在內的許多產品強勁的 14% 銷量增長的推動。在我們推進後期管道並努力在 6 月底前完成對 Horizon 的收購的同時,我們繼續投資以實現長期增長。

  • I'll review our first 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.

    在討論我們的 2023 年指南之前,我將回顧我們的第一季度業績。提醒一下,這些結果和前景反映了安進公司的獨立情況,沒有對已宣布的 Horizon 收購進行任何調整。

  • Turning to our first quarter financial results, which are shown on Slide 38 of the slide deck. Total revenue at $6.1 billion declined 2% year-over-year. However, excluding the 2% negative impact of foreign currency exchange rates, product sales increased 4%, and total revenues were unchanged versus the first quarter of 2022. The 4 percentage point difference was due to an expected decrease in other revenue due to lower profit and cost sharing from our COVID-19 collaboration with Lilly.

    轉向我們第一季度的財務業績,這些業績顯示在幻燈片的第 38 張幻燈片上。總收入為 61 億美元,同比下降 2%。然而,剔除外匯匯率 2% 的負面影響,產品銷售額增長 4%,總收入與 2022 年第一季度持平。4 個百分點的差異是由於利潤下降導致其他收入預計減少以及我們與 Lilly 的 COVID-19 合作的成本分攤。

  • First quarter product sales are seasonally the lowest quarter as a percentage of the full year due to benefits plan changes, insurance reverifications and increased co-pay expenses. In our first quarter, product sales increased 2% year-over-year driven by 14% volume growth, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and the 2% impact of FX rates previously mentioned.

    由於福利計劃變化、保險重新驗證和共同支付費用增加,第一季度產品銷售額佔全年的百分比是季節性最低的。在第一季度,產品銷量同比增長 2%,銷量增長 14%,部分被淨售價下降 5%、預計銷售扣減 3% 的不利變化、庫存水平下降 2% 和 2%前面提到的匯率的影響。

  • First quarter total non-GAAP operating expenses increased 6% year-over-year driven by investments in research and development. Non-GAAP R&D spend in the quarter increased 12% year-over-year with higher spending in later-stage program support, discovery research and early pipeline and marketed product support.

    在研發投資的推動下,第一季度非 GAAP 總運營費用同比增長 6%。本季度非 GAAP 研發支出同比增長 12%,後期項目支持、發現研究以及早期管道和營銷產品支持方面的支出增加。

  • Non-GAAP cost of sales as a percent of product sales increased 0.8 percentage points on a year-over-year basis to 17.4%, primarily due to changes in product mix and a higher profit share expense. Now recall that cost of sales in the first quarter was impacted by a portion of the $125 million of Puerto Rico excise tax that was previously capitalized to inventory, with the residual impact expected in the second quarter.

    非 GAAP 銷售成本佔產品銷售額的百分比同比增長 0.8 個百分點至 17.4%,這主要是由於產品結構的變化和更高的利潤分成費用。現在回想一下,第一季度的銷售成本受到之前資本化為庫存的 1.25 億美元波多黎各消費稅的一部分的影響,預計第二季度會產生剩餘影響。

  • Non-GAAP SG&A expenses in the first quarter increased 1% year-over-year. We continue to focus on prioritizing key investments, digitalization and driving productivity. Non-GAAP OI&E benefited from higher interest income and approximately $110 million of gains from deleveraging related to the repurchase of a portion of our debt portfolio. Also recall, we now mark to market our investment in BeiGene, with the impact included on our GAAP income statement. In the first quarter, this resulted in a GAAP-only pretax gain of about $1.9 billion.

    第一季度非 GAAP SG&A 費用同比增長 1%。我們繼續專注於確定關鍵投資、數字化和提高生產力的優先順序。 Non-GAAP OI&E 受益於更高的利息收入和約 1.1 億美元的去槓桿收益,這些收益與回購我們部分債務組合有關。還記得,我們現在將我們對 BeiGene 的投資計入市場,其影響包含在我們的 GAAP 損益表中。在第一季度,這導致僅按公認會計原則計算的稅前收益約為 19 億美元。

  • As expected, our first quarter non-GAAP tax rate increased 3.7 percentage points to 17.8%, primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023 as well as increased interest expense on our existing tax reserves.

    正如預期的那樣,我們第一季度的非 GAAP 稅率增加了 3.7 個百分點,達到 17.8%,這主要是由於 2022 年波多黎各稅法的變化,從 2023 年開始用所得稅取代消費稅,以及我們現有的利息支出增加稅收儲備。

  • We are committed to our capital allocation priorities. First, we continue our investments in internal and external innovation that drive our long-term growth. Our increased spend in non-GAAP R&D of 12% in Q1 '23 over Q1 '22, coupled with our acquisition of TAVNEOS and our announced acquisition of Horizon Therapeutics, will further broaden and strengthen our portfolio of first-in-class and best-in-class therapeutics to deliver to more patients globally.

    我們致力於我們的資本分配優先事項。首先,我們繼續投資於推動我們長期增長的內部和外部創新。我們在 23 年第一季度的非 GAAP 研發支出比 22 年第一季度增加了 12%,加上我們收購 TAVNEOS 和我們宣布收購 Horizon Therapeutics,將進一步擴大和加強我們一流和最佳的產品組合為全球更多患者提供一流的治療方法。

  • Second, we continue investing in our business to further long-term growth. Capital expenditures are at near-peak levels driven by simultaneous construction of our state-of-the-art manufacturing facilities in Ohio and North Carolina. We expect our annual capital expenditures to decline starting in 2024 with the completion and licensing of our Ohio plant.

    其次,我們繼續投資於我們的業務以進一步實現長期增長。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,資本支出處於接近峰值的水平。我們預計,隨著俄亥俄州工廠的竣工和許可,我們的年度資本支出將從 2024 年開始下降。

  • And third, we continue to return capital to our shareholders as we paid dividends of $2.13 per share in the first quarter. This represented a 10% increase over that paid in each of 2022's 4 quarters.

    第三,我們在第一季度支付了每股 2.13 美元的股息,繼續向股東返還資本。這比 2022 年的 4 個季度中每個季度的支付金額增加了 10%。

  • Free cash flow for the quarter was driven lower by the timing of sales, rebates and incentives, lower operating income and higher capital expenditures from the building out of the state-of-the-art facilities in North Carolina and Ohio. 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%.

    本季度的自由現金流量因銷售時間、回扣和激勵措施、較低的營業收入以及在北卡羅來納州和俄亥俄州建設最先進的設施而增加的資本支出而下降。我們預計今年剩餘時間的現金流強勁,這與我們 2023 年全年的財務展望一致,其中包括約 50% 的非 GAAP 營業利潤率。

  • We expect sequential growth in our free cash flow in the second quarter, although there may be an impact to Q2 and free cash flow from the expected closing of the Horizon acquisition due to the accounting treatment of certain items that were all expected in our Horizon acquisition financing and estimated deal costs as well as our previously announced restructuring in the first quarter.

    我們預計第二季度我們的自由現金流量將連續增長,儘管由於對我們 Horizon 收購中預期的某些項目的會計處理,Horizon 收購的預期結束可能會對第二季度和自由現金流產生影響融資和估計交易成本以及我們之前宣布的第一季度重組。

  • Turning to the outlook for the business for 2023 on Slide 40. Our guidance is currently provided on the Amgen stand-alone business and does not include any Horizon projections. We are raising our 2023 guidance. We're raising our 2023 revenue guidance to $26.2 billion to $27.3 billion versus previous guidance of $26.0 billion to $27.2 billion. This reflects our confidence in the underlying business and the improving overall market conditions for our patients to access our medicines that Bob and Murdo mentioned. We are also raising our 2023 non-GAAP EPS guidance to $17.60 to $18.70 versus previous guidance of $17.40 to $18.60 per share.

    轉向幻燈片 40 上 2023 年的業務前景。我們目前提供的指導是針對安進獨立業務的,不包括任何 Horizon 預測。我們正在提高 2023 年的指導方針。我們將 2023 年的收入指引上調至 262 億美元至 273 億美元,而之前的指引為 260 億美元至 272 億美元。這反映了我們對基礎業務的信心,以及改善我們的患者獲得 Bob 和 Murdo 提到的我們藥物的整體市場條件。我們還將 2023 年非 GAAP 每股收益指引上調至 17.60 美元至 18.70 美元,而之前的指引為每股 17.40 美元至 18.60 美元。

  • Let me mention a few more important considerations as you model the remainder of '23. For product sales, we project solid volume growth at a portfolio level and consistent with the first quarter. We expect a mid-single-digit price decline for our portfolio in 2023. We now project full year Neulasta sales of approximately $700 million and full year combined KANJINTI and MVASI sales of approximately $850 million. We anticipate full year non-GAAP operating expenses to increase by about 1% over last year.

    在您為 23 年的剩餘時間建模時,讓我提一些更重要的考慮因素。對於產品銷售,我們預計產品組合層面的銷量將穩步增長,並與第一季度保持一致。我們預計 2023 年我們的投資組合價格將出現中個位數下降。我們現在預計 Neulasta 全年銷售額約為 7 億美元,KANJINTI 和 MVASI 的全年合併銷售額約為 8.5 億美元。我們預計全年非 GAAP 運營費用將比去年增長約 1%。

  • We expect the 2023 operating margin as a percent of product sales to be roughly 50% and expect our second quarter operating margin to also be roughly 50%. And we also expect cost of sales as a percentage of product sales to be between 16% and 17%; non-GAAP R&D expenses in 2023 to remain unchanged and estimated to increase 3% to 4% year-over-year; non-GAAP SG&A spend as a percentage of product sales to slightly decrease year-over-year driven by our ongoing digitalization, continuous improvement and productivity imperatives.

    我們預計 2023 年營業利潤率佔產品銷售額的百分比約為 50%,並預計我們第二季度的營業利潤率也約為 50%。我們還預計銷售成本佔產品銷售額的百分比在 16% 到 17% 之間; 2023年非美國通用會計準則研發費用保持不變,預計同比增長3%至4%;非 GAAP SG&A 支出佔產品銷售額的百分比在我們持續的數字化、持續改進和生產力的推動下同比略有下降。

  • We anticipate non-GAAP OI&E to be in the range of $1.2 billion to $1.3 billion, reflecting the first quarter deleveraging related to the debt repurchases I mentioned, with the remainder of the year's OI&E expense to be evenly split over the remaining 3 quarters. We expect a non-GAAP tax rate of 18% to 19%. We plan to continue to meaningfully increase our dividend. We continue to expect share repurchases not to exceed $500 million in 2023. Our capital expenditure guidance remains unchanged at approximately $925 million in 2023.

    我們預計非 GAAP OI&E 將在 12 億美元至 13 億美元之間,反映了與我提到的債務回購相關的第一季度去槓桿化,今年剩餘的 OI&E 費用將在剩餘的 3 個季度中平均分配。我們預計非 GAAP 稅率為 18% 至 19%。我們計劃繼續有意義地增加股息。我們繼續預計 2023 年股票回購不會超過 5 億美元。我們的資本支出指引在 2023 年保持不變,約為 9.25 億美元。

  • Our confidence is strong in the long-term outlook for Amgen and our long-term growth. We look forward to completing the announced acquisition of Horizon. We expect to provide updated guidance as appropriate after the transaction closes.

    我們對安進的長期前景和我們的長期增長充滿信心。我們期待完成已宣布的對 Horizon 的收購。我們希望在交易結束後酌情提供更新的指導。

  • Many thanks, as always, to our 24,000-plus dedicated colleagues all over the world executing each day on behalf of our patients and our future patients.

    一如既往,非常感謝我們遍布全球的 24,000 多名敬業的同事每天代表我們的患者和未來的患者開展工作。

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

    財務更新到此結束。我會把它交給鮑勃進行問答。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Thank you, Peter. All right, Julie Anne, if you could remind our callers of the process for asking a question. And I know they've had a long day already, so ask them to hold their questions to one each and do our best to get to everybody who has one for us.

    好的。謝謝你,彼得。好的,朱莉·安妮,如果你能提醒我們的來電者提問的過程。我知道他們已經度過了漫長的一天,所以請他們每個人提出一個問題,並儘最大努力讓每個人都為我們提出問題。

  • Operator

    Operator

  • (Operator Instructions) Our first question comes from Salveen Richter from Goldman Sachs.

    (操作員說明)我們的第一個問題來自高盛的 Salveen Richter。

  • Salveen Jaswal Richter - VP

    Salveen Jaswal Richter - VP

  • For TEZSPIRE, you've highlighted the broad clinical program. And given the Phase II data sets we're expecting this year and next year, could you just comment on the indications where you have the most confidence in?

    對於 TEZSPIRE,您強調了廣泛的臨床項目。鑑於我們預計今年和明年的 II 期數據集,您能否評論一下您最有信心的適應症?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Dave, over to you.

    戴夫,交給你了。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. Thanks, Salveen. All of the indications that we're pursuing have some mechanistic basis in chronic spontaneous urticaria, eosinophil-driven disease in part, as is eosinophil esophagitis. And given the mechanism of TSLP inhibition, that underlaid the thinking behind pursuing those indications.

    是的。謝謝,薩爾文。我們尋求的所有適應症在慢性自發性蕁麻疹、部分嗜酸性粒細胞驅動的疾病以及嗜酸性粒細胞性食管炎中都有一些機制基礎。鑑於 TSLP 抑制的機制,這奠定了追求這些適應症背後的想法。

  • As I've mentioned briefly, in COPD, as another example, there is accumulating evidence that triggers such as viral infections, smoke, particles from pollutants can trigger TSLP release from bronchial epithelium. These are consistent with data showing that, in patients with COPD, TSLP levels are elevated in sputum, bronchoalveolar lavage fluid and bronchial mucosa. And so as I mentioned, that trial is fully enrolled. We expect a data readout given the duration of therapy that one wants to see in these patients in the first half of next year. So I think there's good mechanistic basis. We're in clinical trial execution mode now and really waiting data readouts.

    正如我簡要提到的,在 COPD 中,作為另一個例子,有越來越多的證據表明病毒感染、煙霧、污染物顆粒等觸發因素可以觸發 TSLP 從支氣管上皮釋放。這些與顯示 COPD 患者痰液、支氣管肺泡灌洗液和支氣管粘膜中 TSLP 水平升高的數據一致。正如我所提到的,該試驗已完全註冊。考慮到人們希望在明年上半年看到這些患者的治療持續時間,我們預計會得到數據讀數。所以我認為有很好的機械基礎。我們現在處於臨床試驗執行模式,真正等待數據讀取。

  • Operator

    Operator

  • Our next question comes from Michael Yee from Jefferies.

    我們的下一個問題來自 Jefferies 的 Michael Yee。

  • Michael Jonathan Yee - Equity Analyst

    Michael Jonathan Yee - Equity Analyst

  • Following on the pipeline, maybe for David, I think what's interesting is that you obviously had AMG 133 obesity data, and now you are emphasizing AMG 786. And I think it's enrolling and treating people now. Can you just talk a little bit about why you'd be excited about that? Is that synergistic? Is there an angle with that to be excited about given all of the things going on in obesity?

    在管道之後,也許對於大衛來說,我認為有趣的是你顯然有 AMG 133 肥胖數據,而現在你正在強調 AMG 786。我認為它現在正在招募和治療人們。你能談談為什麼你會對此感到興奮嗎?那是協同作用嗎?考慮到肥胖症正在發生的所有事情,有什麼值得興奮的角度嗎?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. I think what you said at the end there is very important, Mike, in terms of everything that's going on in obesity. If we just step back for a second and think about what the magnitude of the problem is here, there are hundreds of millions of patients now globally. We are doing an experiment in the 21st century that the world has never done by creating an obesity crisis.

    是的。我認為你最後所說的非常重要,邁克,就肥胖症正在發生的一切而言。如果我們退後一步,想想這裡問題的嚴重性,全球現在有數億患者。我們正在 21 世紀進行一項世界從未做過的實驗,即製造肥胖危機。

  • Now recall obesity, a single disease, but it is clearly a complex heterogeneous disorder. There are undoubtedly patient subsets buried within that, and different patients may well benefit from different therapies. This is a disorder that's rooted in human evolution and now is a function of our environment. And so our development program for both 133 and for the molecules that will follow behind really intends to capitalize on the fact that there's a very large volume of patients with the heterogeneous disorder. I think this is a field that is in its infancy, and we have a chance to help define what those patient subsets are and who will benefit from specific therapies using, for example, our industry-leading database of multiomic profiling, which we intend to employ aggressively in these development programs.

    現在回想一下,肥胖是一種單一的疾病,但它顯然是一種複雜的異質性疾病。毫無疑問,其中隱藏著一些患者亞群,不同的患者可能會從不同的治療中受益。這是一種植根於人類進化的疾病,現在是我們環境的一種功能。因此,我們針對 133 和後續分子的開發計劃真正打算利用這樣一個事實,即有大量患者患有異質性疾病。我認為這是一個處於起步階段的領域,我們有機會幫助定義那些患者子集是什麼以及誰將從特定療法中受益,例如,我們打算使用我們行業領先的多組學分析數據庫積極參與這些發展計劃。

  • You mentioned AMG 786, and I'll just conclude with a comment on that. That is a non-incretin-based mechanism of action. And I think that is also an area that will be very fertile for drug development, and it's a focus of us preclinically as well right now. So thanks for the question. It's early days, but we think that this is one of the big public health challenges of the current century.

    您提到了 AMG 786,我將對此發表評論作為結尾。這是一種非基於腸促胰島素的作用機制。我認為這也是一個非常適合藥物開發的領域,也是我們目前臨床前關注的焦點。所以謝謝你的問題。現在還為時尚早,但我們認為這是本世紀面臨的重大公共衛生挑戰之一。

  • Operator

    Operator

  • 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。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I'm a little confused today about some of the numbers I'm looking at. So for example, I mean, you know well, AbbVie's Humira went biosimilar. You guys are the ones that launched it. And AbbVie reported they're down 26% year-over-year. So I guess what I don't understand is how come Enbrel is down 33% year-over-year, more so than the company that did go biosimilar. And I think some of that speaks to a little bit of the inventory issues that are happening, and they seem quite significant the more I think about the magnitude reported. For example, a 21% drop on Enbrel and 28% drop on Otezla, which almost sounds like 3 weeks' worth of work down. I usually think of total inventory in the channel being about 3 weeks. So I would love to get any clarity there.

    我今天對我正在查看的一些數字感到有些困惑。因此,例如,我的意思是,你很清楚,艾伯維(AbbVie)的修美樂(Humira)進行了生物仿製藥。你們是發起它的人。艾伯維(AbbVie)報告說他們同比下降了 26%。所以我想我不明白的是,為什麼 Enbrel 同比下降了 33%,比採用生物仿製藥的公司下降得更多。而且我認為其中一些說明了正在發生的一些庫存問題,而且我對所報告的數量級的思考越多,它們就越重要。例如,Enbrel 下降了 21%,Otezla 下降了 28%,這聽起來幾乎相當於 3 週的工作量。我通常認為渠道中的總庫存約為 3 週。所以我很想在那裡弄清楚。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Umer. You're on to some of the fact pattern. Let me just go through kind of the elements of Enbrel specifically. First off, we were up 1% in volume in the quarter. So the leading indicators of Enbrel volume performance all look quite good. And that's a function of strong demand for the product in the market, good quality execution and an additional pharmacy benefit formulary win starting in January of the year. So we would expect continued low single-digit volume growth throughout the course of 2023. So that's the kind of high-quality leading indicators of the volume performance of the product.

    是的。謝謝,烏默爾。您正在了解一些事實模式。讓我具體介紹一下 Enbrel 的元素。首先,本季度我們的銷量增長了 1%。因此,Enbrel 體積性能的領先指標看起來都相當不錯。這是市場對產品的強勁需求、良好的質量執行以及從今年 1 月開始的額外藥房福利處方的功能。因此,我們預計在整個 2023 年期間銷量將繼續保持低個位數增長。這就是產品銷量表現的高質量領先指標。

  • The inventory component is pretty substantial, as you highlight. It is a function of both wholesaler inventory levels being down as well as specialty pharmacy. And I think it's partly a function of the fact that we did have volume increase, and there was also a pretty significant work down through the quarter. We would expect those inventory levels to return to normal inventory levels throughout the course of the year.

    正如您強調的那樣,庫存部分非常重要。這是批發商庫存水平下降以及專業藥房下降的結果。我認為這在一定程度上是因為我們確實增加了銷量,而且整個季度也有相當重要的工作。我們預計這些庫存水平將在全年恢復到正常庫存水平。

  • And then the last piece of Enbrel is an out-of-period adjustment, an unfavorable adjustment, of about 9% related to prior period. And that's a function of things like state Medicaid true-ups coming in as well as some other price adjustments from prior period.

    然後最後一塊Enbrel是一個期外調整,一個不利的調整,大約與前期相關9%。這是諸如州醫療補助計劃調整以及前期其他一些價格調整等因素的作用。

  • So overall, again, the leading indicators for Enbrel are good, low single-digit volume anticipated for the year, a little bit of price concession to get that formulary win. But then the other 2 events in the quarter are likely to improve over the course of the year as well, being inventory and prior period adjustment.

    因此,總的來說,Enbrel 的領先指標再次良好,預計今年的銷量將達到較低的個位數,為獲得處方藥的勝利而做出一點價格讓步。但隨後本季度的其他兩個事件也可能在一年中有所改善,即庫存和前期調整。

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • And maybe, Murdo, just to jump in quickly, that prior period adjustment, I mean that's an estimated sales deduction adjustment.

    默多,也許只是為了快速進入前期調整,我的意思是這是估計的銷售扣除調整。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thank you, Peter.

    是的。謝謝你,彼得。

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • Yes. So just to clarify that, and as Murdo said, we're looking for a slowing year-over-year price erosion on that, too. So we think we've got some trends in our favor here.

    是的。因此,為了澄清這一點,正如 Murdo 所說,我們也在尋找同比價格下降的放緩。所以我們認為我們在這裡有一些對我們有利的趨勢。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. There is a big piece of that prior period that's also PHS. And given the program that we're running for PHS patients, we expect that to be a lower impact throughout the course of the year as well.

    是的。前期有很大一部分也是 PHS。考慮到我們為 PHS 患者開展的計劃,我們預計這一年的影響也會降低。

  • Operator

    Operator

  • 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。

  • Christopher Joseph Raymond - MD & Senior Research Analyst

    Christopher Joseph Raymond - MD & Senior Research Analyst

  • I have a question on the biosimilar business. I'm not sure I heard this correctly or not, but from Murdo's comments, it sounds like AMJEVITA revenue might be fairly front-loaded given the inventory build that I think you guys described. I know you guys don't give quarterly granularity, but maybe talk about the outlook for the rest of the year, especially given that you have a bunch of other biosimilar launches happening in that specific space. And then maybe just more strategically, just given the expectations have been kind of tempered here with AMJEVITA, you guys still seem pretty committed to this business with SOLIRIS, EYLEA, STELARA launches. Just maybe talk about why these won't maybe see a similar tempering of expectations.

    我有一個關於生物仿製藥業務的問題。我不確定我是否聽錯了,但從 Murdo 的評論來看,考慮到我認為你們所描述的庫存構建,AMJEVITA 的收入聽起來可能相當前期。我知道你們不會給出季度粒度,但也許可以談談今年剩餘時間的前景,特別是考慮到你們在那個特定領域有很多其他生物仿製藥上市。然後可能只是更具戰略意義,鑑於 AMJEVITA 的預期有所緩和,你們似乎仍然非常致力於 SOLIRIS、EYLEA 和 STELARA 推出的這項業務。也許只是談談為什麼這些可能不會看到類似的期望回火。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks for the question, Chris. On AMJEVITA specifically, a lot of that Q1 revenue was what we would call buy-in from primarily IDNs. And so it's hard for us to see how much of that buy-in has been used up in actual prescription fill. So our conservative estimate is that the majority of that is buy-in and that Q2 could be lower than Q1 revenues based on that. So that's our estimate for AMJEVITA. Obviously, we're very early in the launch here. We're building demand physician by physician and patient by patient. And some of that IDN pull-through is not visible to us because they don't share data necessarily with the IQVIAs of the world. So that's AMJEVITA.

    是的。謝謝你的問題,克里斯。特別是在 AMJEVITA 上,第一季度的大部分收入都是我們所說的主要來自 IDN 的買入。因此,我們很難看出實際處方中有多少買入已經用完了。因此,我們的保守估計是,其中大部分是買入,第二季度的收入可能低於基於此的第一季度收入。這就是我們對 AMJEVITA 的估計。顯然,我們在這裡的發布還很早。我們正在逐個醫生和逐個患者建立需求醫生。我們看不到 IDN 中的一些 pull-through,因為它們不一定與世界各地的 IQVIA 共享數據。這就是 AMJEVITA。

  • But overall, we have been extremely successful in developing biosimilars at Amgen. We are very pleased with what we've been able to do so far by developing successful molecules that are either first or first wave launches. We continue to plan on being first or first wave in the biosimilar products that we're targeting. We have been able to continuously supply, thanks to the hard work of our manufacturing and supply chain colleagues around the world. When we approach both institutional customers, payers and providers, I think there's a lot of trust in the Amgen brand when it comes to the biosimilars that we manufacture.

    但總的來說,我們在 Amgen 開發生物仿製藥方面非常成功。我們對迄今為止通過開發第一波或第一波發射的成功分子所做的事情感到非常滿意。我們繼續計劃成為我們所針對的生物仿製藥產品的第一波或第一波浪潮。我們能夠持續供應,這要歸功於我們在世界各地的製造和供應鏈同事的辛勤工作。當我們接觸機構客戶、付款人和供應商時,我認為在我們生產的生物仿製藥方面,人們對安進品牌有很大的信任。

  • Certainly, last but not least, we do feel strongly that we will continue to be able to deliver on our 2x '21 sales by the end of the decade in our biosimilars business, so more than double our 2021 revenues. And we think we'll do that by continuing to launch both pharmacy benefit and medical benefit biosimilars. But the majority of that growth is going to be driven by medical benefit biosimilars. So still a very important part of our business and the people that work on it, continue to deliver value to the health care system as we move forward.

    當然,最後但並非最不重要的一點是,我們確實強烈認為,到本世紀末,我們的生物仿製藥業務將能夠繼續實現 21 年銷售額的 2 倍,因此我們 2021 年的收入將增加一倍以上。我們認為我們將通過繼續推出藥房福利和醫療福利生物仿製藥來做到這一點。但大部分增長將由醫療效益生物仿製藥推動。因此,我們業務的一個非常重要的部分和從事這項工作的人員,在我們前進的過程中繼續為醫療保健系統創造價值。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • The only thing I'd add to that, Chris, is that we're running this business very efficiently, and we think, when we look at the cash that we're generating on this business, we're earning an attractive return for our shareholders. So again, in order for us to continue to succeed in biosimilars, we need to execute effectively. And as you can see in the quarter with the BEKEMV progress and with the launch of AMJEVITA, we continue to do what we plan to do in biosimilars. And again, I would reiterate, we think we're earning an attractive return for our shareholders on those commitments.

    克里斯,我唯一要補充的是,我們正在非常有效地經營這項業務,而且我們認為,當我們查看我們在這項業務中產生的現金時,我們正在獲得有吸引力的回報我們的股東。因此,為了讓我們繼續在生物仿製藥領域取得成功,我們需要有效執行。正如您在本季度看到的 BEKEMV 進展和 AMJEVITA 的推出,我們繼續做我們計劃在生物仿製藥中做的事情。再一次,我要重申,我們認為我們正在為我們的股東贏得這些承諾的有吸引力的回報。

  • Operator

    Operator

  • Our next question comes from Mohit Bansal from Wells Fargo.

    我們的下一個問題來自富國銀行的 Mohit Bansal。

  • Mohit Bansal - Senior Equity Analyst

    Mohit Bansal - Senior Equity Analyst

  • My question is also related to biosimilar. Given that the demand so far doesn't look to be ticking up for Humira, and your comments about next quarter also suggest that it may be a slow launch here, do you think this would mean that you are losing the first mover advantage here? Or is there a way next year AMJEVITA could be more on a preferred side of formulary rather than parity? Because it seems like parity is not cutting it just yet.

    我的問題也與生物仿製藥有關。鑑於到目前為止 Humira 的需求似乎沒有上升,而且您對下一季度的評論也表明它可能會在這裡緩慢推出,您認為這是否意味著您在這裡失去了先發優勢?或者明年 AMJEVITA 是否有辦法更偏向於處方集而不是均等?因為看起來平價還沒有削減它。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks for the question, Mohit. I think we've definitely taken advantage of first mover, particularly with the IDN channel. That's really where a lot of the initial uptake will be. I think we're also differentiated versus the other biosimilar manufacturers that have biosimilars to Humira in that we do cover the customer base here quite effectively, both in rheumatology and gastroenterology, having deployed medical and sales teams that are out there right now building awareness and demand for AMJEVITA.

    是的。謝謝你的問題,莫希特。我認為我們肯定已經利用了先發優勢,尤其是在 IDN 渠道方面。這確實是很多最初吸收的地方。我認為我們也與其他擁有 Humira 生物仿製藥的生物仿製藥製造商不同,因為我們確實非常有效地覆蓋了這裡的客戶群,包括風濕病學和胃腸病學,已經部署了醫療和銷售團隊,現在正在那裡建立意識和對 AMJEVITA 的需求。

  • Lastly, I would say that given that we've got parity access across the large 3 PBMs, we are in very good position to be able to pull through a lot of that AMJEVITA. I think we were clear in saying this would be a gradual uptake for this product. And we think that we still have been able to use the time that we have ahead of competition wisely to build that demand.

    最後,我要說的是,鑑於我們已經在 3 個大型 PBM 中獲得了平等訪問權,我們處於非常有利的位置,能夠通過很多 AMJEVITA 。我認為我們明確表示這將是對該產品的逐步採用。而且我們認為我們仍然能夠明智地利用領先於競爭對手的時間來建立這種需求。

  • Operator

    Operator

  • Our next question comes from Jay Olson from Oppenheimer.

    我們的下一個問題來自 Oppenheimer 的 Jay Olson。

  • Jay Olson - Executive Director & Senior Analyst

    Jay Olson - Executive Director & Senior Analyst

  • Curious about Otezla and how you expect the pricing dynamics to evolve over the course of the year, especially in the context of the TYK2 being mostly 3 drugs right now. How do you expect the pricing for Otezla to evolve following the transition to TYK2 and to paid customers?

    對 Otezla 感到好奇,以及您期望定價動態在一年中如何演變,尤其是在 TYK2 目前主要是 3 種藥物的情況下。在向 TYK2 和付費客戶過渡後,您預計 Otezla 的定價將如何演變?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thank you, Jay. I think what we're pleased with is the broad access coverage we have on Otezla. We have very good coverage. We did actually add additional coverage at the beginning of the year with United Optum Part D plan coming online. And so there's a little bit of price concession to do that in the year. But beyond that, we've got good stable access for 2023, and we look forward to being able to maintain that in 2024. So I don't see more decrement on price. In fact, we think the negative price effects you saw in Q1 should abate a little bit in Q2 and beyond. So overall, very stable.

    是的。謝謝你,傑伊。我認為我們對 Otezla 的廣泛訪問範圍感到滿意。我們有很好的報導。我們確實在今年年初通過 United Optum Part D 計劃上線增加了額外的承保範圍。因此,在這一年裡這樣做會有一點價格優惠。但除此之外,我們在 2023 年獲得了良好的穩定訪問,我們期待能夠在 2024 年保持這種訪問。所以我認為價格不會進一步下降。事實上,我們認為您在第一季度看到的負面價格影響在第二季度及以後應該會有所減弱。所以總體而言,非常穩定。

  • The one thing that you mentioned that's interesting is the Free Goods Program that competitors have out there. I do think that that's a little bit of a disruption in the market right now. That's probably causing a bit of softness in our new patient demand. We get about 80% of our new patient growth coming from systemic-naive topical patients receiving Otezla as their first systemic agent. I think when you have Free Goods Programs in the market, sometimes that free goods is a very easy way for a prescriber to try a novel agent. And I think that that's taking away some of that new patient growth that we're used to seeing. I do think that, that will be different once those competitors contract for their market access, and that's likely to be a '24 impact.

    您提到的一件有趣的事情是競爭對手推出的免費商品計劃。我確實認為現在市場有點混亂。這可能導致我們對新患者的需求有所減弱。我們大約 80% 的新患者增長來自接受 Otezla 作為他們的第一個全身藥物的全身性外用患者。我認為當市場上有免費商品計劃時,有時免費商品是開處方者嘗試新型藥物的一種非常簡單的方式。而且我認為這正在帶走我們習慣看到的一些新患者的增長。我確實認為,一旦這些競爭對手簽訂市場准入合同,情況就會有所不同,這很可能是 24 世紀的影響。

  • Operator

    Operator

  • Our next question comes from Colin Bristow from UBS.

    我們的下一個問題來自瑞銀的 Colin Bristow。

  • Colin Nigel Bristow - Analyst

    Colin Nigel Bristow - Analyst

  • So one for Murdo. You've now got the chronic TEPEZZA data. I just wondered, could you give us your thoughts on this? And does this, in any way, change your view on the size of the commercial opportunity? And then a quick kind of housekeeping one on LUMAKRAS, how much of the weakness this quarter was sort of net pricing versus competition from Mirati?

    所以一個給默多。您現在已經獲得了長期的 TEPEZZA 數據。我只是想知道,你能給我們談談你的想法嗎?這是否會以任何方式改變您對商業機會規模的看法?然後是 LUMAKRAS 上的一種快速內務管理,本季度的弱點有多少是淨定價與來自 Mirati 的競爭?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks, Colin. maybe I could take a minute just on TEPEZZA because there are quite a few analysts on the call that would be unfamiliar with how the patient journey for thyroid eye disease actually works. And it's important because it has a bearing on the demand pattern for TEPEZZA. The way in which the Horizon team actually track the performance is they look at something called patient enrollment forms, which is the initial request, if you will, to start a thyroid eye disease patient on TEPEZZA. It then takes quite a while for that patient enrollment form to move its way through the prior authorization process against medical policies that payers have in place. That can take up to 90 days.

    謝謝,科林。也許我可以花一分鐘時間談談 TEPEZZA,因為有很多分析師不熟悉甲狀腺眼病患者的實際治療過程。這很重要,因為它與 TEPEZZA 的需求模式有關。 Horizon 團隊實際跟踪表現的方式是他們查看稱為患者登記表的東西,如果你願意的話,這是在 TEPEZZA 上開始甲狀腺眼病患者的初始請求。然後,該患者登記表需要相當長的時間才能通過預先授權程序,以反對付款人制定的醫療政策。這最多可能需要 90 天。

  • Then you need to schedule that patient's first infusion. And in thyroid eye disease, it's not like in oncology where there's a clinical oncologist relatively evenly distributed throughout the country that can do infused drug administration. This is a lot more concentrated. And so it takes a while for the patient to be referred to the right site of care to receive their first infusion of TEPEZZA. So that also adds time.

    然後您需要安排該患者的首次輸液。在甲狀腺眼病中,它不像在腫瘤學中那樣,那裡有一名臨床腫瘤學家相對均勻地分佈在全國各地,可以進行輸液給藥。這要集中得多。因此,需要一段時間才能將患者轉診到正確的護理地點以接受他們的第一次 TEPEZZA 輸注。所以這也增加了時間。

  • So while tracking the early leading indicator that we look at, which is patient enrollment form, there's quite a lag between that patient enrollment form starting and when that first infusion will occur. And that's really important to keep in mind when you see either flat or, in this case, I think strengthening demand for TEPEZZA in patient enrollment forms. That will take a while to flow through into net sales. So that would be my prefacing comment.

    因此,在跟踪我們查看的早期領先指標(即患者登記表)時,從患者登記表開始到第一次輸液發生的時間之間存在相當大的滯後。當你看到持平或在這種情況下,我認為患者登記表中對 TEPEZZA 的需求增加時,記住這一點非常重要。這將需要一段時間才能流入淨銷售額。這就是我的開場白。

  • Now besides that, I think we're really excited, as Dave said, about the chronic data that were recently announced. And my congratulations to the entire Horizon team for executing a high-quality trial and showing how TEPEZZA can benefit a broader cross-section of patients with lower clinical activity score and truly highlighting the need for chronic care in this category. So I think that's a fantastic accomplishment. I think the simultaneous label change is just a nod to the conviction that even the regulator has about the utility of this product and this disease.

    除此之外,正如 Dave 所說,我認為我們對最近公佈的長期數據感到非常興奮。我祝賀整個 Horizon 團隊執行了一項高質量的試驗,並展示了 TEPEZZA 如何使臨床活動評分較低的更廣泛的患者受益,並真正強調了此類患者對慢性病護理的需求。所以我認為這是一個了不起的成就。我認為同時更改標籤只是對這樣一種信念的認可,即即使是監管機構也對這種產品和這種疾病的效用有所了解。

  • And then I think the Horizon team has spent a lot of time over the last few months expanding their commercial capabilities and their medical capabilities. And they're in really good shape to take this great new data, which is on label, to providers and to payers and to help expand the use of that product in the U.S. So we're quite optimistic about the future growth of TEPEZZA.

    然後我認為 Horizon 團隊在過去幾個月里花了很多時間來擴展他們的商業能力和醫療能力。他們的狀態非常好,可以將標籤上的這些偉大的新數據提供給供應商和付款人,並幫助擴大該產品在美國的使用。因此,我們對 TEPEZZA 的未來增長非常樂觀。

  • And then, of course, from our side, we're also excited about being able to launch TEPEZZA in other markets around the world once we close this transaction. We have the capabilities and the structure and the scale given that we've been expanding Amgen's footprint globally over the last several years. And so we're ready to go. And we'll work closely with Horizon to do that so that TEPEZZA has multiple opportunities to grow over time.

    然後,當然,從我們這邊來說,我們也很高興能夠在我們完成這筆交易後在全球其他市場推出 TEPEZZA。鑑於我們在過去幾年中一直在全球範圍內擴大安進的足跡,我們擁有能力、結構和規模。所以我們準備好了。我們將與 Horizon 密切合作,以便 TEPEZZA 有多個機會隨著時間的推移而發展。

  • On LUMAKRAS, just real quick, we did see a little bit of increased inventory in the fourth quarter of last year. So the year-on-year compare -- or quarter-on-quarter compare, I should say, is really more about that inventory coming through. The actual demand is pretty flat from Q4 to Q1. And so we've been able to hold on quite nicely despite competitors in the market.

    在 LUMAKRAS 上,很快,我們確實看到去年第四季度的庫存有所增加。因此,我應該說,同比比較——或環比比較,實際上更多的是關於庫存的變化。從第四季度到第一季度,實際需求相當平穩。因此,儘管市場上有競爭對手,我們仍然能夠很好地堅持下去。

  • Operator

    Operator

  • 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。

  • Brendan Mychal Smith - Associate

    Brendan Mychal Smith - Associate

  • This is Brendan on for Yaron. Just another quick one, a follow-up on TEZSPIRE, maybe specifically in CSU. Can you give us a little bit of a sense of where you maybe see the bar for this midyear readout here? Our understanding is that the mast cells are really one of the key players in CSU. And if TSLP is maybe a bit of a broader target, how do you see its impact in the disease course? Just trying to kind of understand relative positioning here and maybe gauge expectations for the Phase II data.

    這是 Yaron 的 Brendan。只是另一個快速的,TEZSPIRE 的跟進,可能特別是在 CSU 中。你能給我們一些關於你可能在這裡看到這個年中讀數的酒吧的感覺嗎?我們的理解是,肥大細胞確實是 CSU 的關鍵參與者之一。如果 TSLP 可能是一個更廣泛的目標,您如何看待它對疾病過程的影響?只是想了解這裡的相對定位,並可能衡量對第二階段數據的預期。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. Thanks. Look, the trial is fully enrolled. We're bringing in data. I think within a few months, we're going to have the data set in hand. I think I've outlined mechanistically why TSLP being upstream could be one of the triggers that, if inhibited, could serve as a therapy for the disease. At this point, I think it's really just getting the data set.

    是的。謝謝。看,試驗已經完全註冊了。我們正在引入數據。我認為在幾個月內,我們將掌握數據集。我想我已經從機制上概述了為什麼 TSLP 處於上游可能是觸發因素之一,如果被抑制,可以作為疾病的治療方法。在這一點上,我認為它真的只是獲取數據集。

  • Operator

    Operator

  • Our next question comes from Evan Seigerman from BMO Capital Markets.

    我們的下一個問題來自 BMO Capital Markets 的 Evan Seigerman。

  • Evan David Seigerman - MD & Senior BioPharma Research Analyst

    Evan David Seigerman - MD & Senior BioPharma Research Analyst

  • On Otezla, we've noted over several quarters we know the demand kind of issues that are playing out. Anything you can do from a commercial perspective that could help accelerate growth even in light of the free drug program (sic) [Free Goods Program] we're seeing? Or do we really have to wait until that kind of tapers off come next year to maybe see some more growth from the brand?

    在 Otezla 上,我們已經註意到幾個季度以來我們知道需求類型的問題正在上演。即使考慮到我們正在看到的免費藥物計劃 (sic) [免費商品計劃],您可以從商業角度做任何有助於加速增長的事情嗎?或者我們真的必須等到明年這種逐漸減少的情況才能看到品牌的更多增長嗎?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Evan. We're obviously doing quite a bit in the market from a commercial perspective. We've actually increased the breadth of our promotion to include much more primary care targets given that the milder patient who's on topical therapy today, that 1.5 million patient pool, it's a large addressable pool of patients, are currently under the care of primary care physicians and tend not to be referred as frequently to dermatologists as the moderate-to-severe patients. So we've increased our primary care footprint, and we're actually seeing growth in our primary care targets.

    是的。謝謝,埃文。從商業角度來看,我們顯然在市場上做了很多。我們實際上已經擴大了我們的推廣範圍,以包括更多的初級保健目標,因為今天接受局部治療的較輕的患者,即 150 萬患者庫,這是一個龐大的可尋址患者庫,目前正在接受初級保健醫生,往往不像中度至重度患者那樣經常被轉診給皮膚科醫生。因此,我們增加了我們的初級保健足跡,我們實際上看到了初級保健目標的增長。

  • Where we're seeing a little bit of pressure, a little bit of quarter-on-quarter pressure, is in the higher-end dermatology practices that treat more complex patients. And that's kind of where you would expect to see some of the novel agents being tried. So I do think that will stabilize over time, but that's going to take most of the year to take place. We'll continue to expand our primary care presence, and we're also working to expand our direct-to-consumer efforts to a mild-to-moderate patient population that might be on a topical but still seeing unresolved symptoms due to their psoriasis, whether it be hands, face, scalp or other areas where the patient really wants to resolve those symptoms.

    我們看到一點點壓力,一點點環比壓力,是在治療更複雜患者的高端皮膚科實踐中。這就是您希望看到一些正在嘗試的新代理的地方。所以我確實認為這會隨著時間的推移而穩定下來,但這將需要一年中的大部分時間才能發生。我們將繼續擴大我們的初級保健業務,我們也在努力將我們直接面向消費者的努力擴大到輕度至中度患者群體,這些患者群體可能正在局部使用但由於牛皮癬仍未得到解決的症狀,無論是手、臉、頭皮還是患者真正想要解決這些症狀的其他部位。

  • So overall, there's quite a bit that we're putting into the market to increase our growth in that bio-naive or systemic-naive milder patient. And we would expect that, that will strengthen our new patient capture over the course of the year, and we expect to see good growth for Otezla for many years to come.

    所以總的來說,我們正在投入市場以增加我們在生物天真或系統天真的溫和患者中的增長。我們預計,這將在這一年中加強我們的新患者捕獲,我們預計 Otezla 在未來許多年內將實現良好增長。

  • Operator

    Operator

  • Our next question comes from Robyn Karnauskas from Truist Securities.

    我們的下一個問題來自 Truist Securities 的 Robyn Karnauskas。

  • Nicole Germino - Associate

    Nicole Germino - Associate

  • This is Nicole on for Robyn. Can you help us think through the Neulasta franchise and how Amgen plans on maintaining share given that there are competitors with biosimilars with auto-injector devices and other devices in the market? How much pressure should we see going forward? How should we think about the Neulasta franchise?

    這是羅賓的妮可。您能否幫助我們思考 Neulasta 的特許經營權,以及鑑於市場上存在帶有自動注射器設備和其他設備的生物仿製藥的競爭對手,Amgen 計劃如何保持份額?未來我們應該看到多大的壓力?我們應該如何看待 Neulasta 特許經營權?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thank you, Nicole, for the question. Look, we're really pleased with what we've been able to do with the Neulasta franchise to date. We've been able to defend our volume successfully. Obviously, we've had to concede some price to do that. And the volume on the prefilled syringe side has been under some pressure. I'm very pleased with what we've done with the Neulasta Onpro device, and we've held on to substantial share there. We think we've established good contractual commitments for this year, and we'll continue to battle with competitors if they come to market with a different device than is currently available. But we expect some continued pricing pressure there, as we've indicated. And overall, I think the team that's working on Neulasta has done very well.

    妮可,謝謝你提出這個問題。看,我們對迄今為止我們能夠對 Neulasta 特許經營權所做的事情感到非常滿意。我們已經能夠成功地捍衛我們的數量。顯然,我們不得不為此付出一些代價。並且預充式註射器一側的體積已經承受了一定的壓力。我對我們在 Neulasta Onpro 設備上所做的一切感到非常滿意,並且我們在那裡佔據了相當大的份額。我們認為我們已經為今年建立了良好的合同承諾,如果他們以不同於當前可用的設備進入市場,我們將繼續與競爭對手進行鬥爭。但正如我們已經指出的那樣,我們預計那裡會有一些持續的定價壓力。總的來說,我認為在 Neulasta 上工作的團隊做得很好。

  • Operator

    Operator

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

    我們的下一個問題來自 RBC Capital Markets 的 Gregory Renza。

  • Gregory James Renza - Analyst

    Gregory James Renza - Analyst

  • Congrats on the quarter. Rob, at the top of the call, you spoke about your R&D and I think it was 4 medicines that you described as quintessentially Amgen. And just my question just for you and the team, as you look across your portfolio but also externally in other areas, are there specific areas of opportunity that you think could benefit from the Amgen capabilities that perhaps are not represented or underrepresented in your portfolio today?

    祝賀這個季度。 Rob,在電話會議的最前面,你談到了你的研發,我認為這是你描述為典型的 Amgen 的 4 種藥物。我的問題只是問你和團隊,當你審視你的投資組合以及其他領域的外部時,你是否認為有特定的機會領域可以從安進的能力中受益,而這些能力在你今天的投資組合中可能沒有代表或代表不足?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • David and I can tackle that together. I think we've been very clear about what we look for in the outside, which are molecules that fit in our areas of strategic interest or where we think we have strength. And in particular, we're looking for opportunities in inflammation and in oncology and in general medicine. And we look for medicines that could be first-in-class, best-in-class and have a big effect size in the patient populations that, again, where we think we can add value. So we're constantly looking. I don't think we feel like we're particularly exposed or we need to emphasize business development in any one of those 3 particular areas, but we're always looking for attractive opportunities early and late. Dave?

    大衛和我可以一起解決這個問題。我認為我們已經非常清楚我們在外部尋找什麼,這些分子適合我們的戰略利益領域或我們認為我們有實力的領域。特別是,我們正在尋找炎症、腫瘤學和普通醫學領域的機會。我們尋找的藥物可能是一流的、一流的,並且對患者群體有很大的影響,同樣,我們認為我們可以在這些地方增加價值。所以我們一直在尋找。我不認為我們覺得我們特別暴露,或者我們需要強調這三個特定領域中任何一個的業務發展,但我們總是在早晚尋找有吸引力的機會。戴夫?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. And I would add, the other component is technology platforms. Bob mentioned briefly in his opening remarks of the use of artificial intelligence and machine learning. I think we've quietly become a leader in this area. We are using artificial intelligence and machine learning across the R&D spectrum now from molecular engineering where we've been extraordinarily pleased with on the effect of dry labs or in silico design on the engineering of new protein molecules in time frames that are much, much shorter than were previously achievable with a higher success rate, success here being defined as a candidate going forward that has the molecular attributes that you want. We are using it extensively in the clinical trials arena for site selection, for example, and other aspects of trial design. .

    是的。我要補充的是,另一個組成部分是技術平台。 Bob在開場白中簡要提到了人工智能和機器學習的使用。我認為我們已經悄然成為該領域的領導者。現在,我們在分子工程的整個研發範圍內使用人工智能和機器學習,我們對乾燥實驗室或計算機設計對新蛋白質分子工程的影響感到非常滿意,時間框架要短得多比以前更高的成功率,這裡的成功被定義為具有您想要的分子屬性的候選人。例如,我們在臨床試驗領域廣泛使用它進行選址和試驗設計的其他方面。 .

  • So this is something that I'll talk about more as we go through the course of the year. But these sorts of technology platforms lead us to what I think is an absolute hinge moment in this industry where the union of tech and biotech will move us forward to a qualitatively different time in drug discovery and drug development. And I think we're going to be very well positioned to take advantage of this union.

    所以這是我將在今年的過程中更多地談論的事情。但這些類型的技術平台將我們帶到了我認為是這個行業的絕對關鍵時刻,技術和生物技術的結合將推動我們在藥物發現和藥物開發方面進入一個質的不同時代。而且我認為我們將能夠很好地利用這個聯盟。

  • Operator

    Operator

  • Our next question comes from Tim Anderson from Wolfe Research.

    我們的下一個問題來自 Wolfe Research 的 Tim Anderson。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • On Otezla, I'm wondering if you have any market share or performance metrics in the mild psoriasis segment, specifically, where you've had approval for coming up on 1.5 years. I'm guessing you have some idea of the penetration you're making in that very different segment.

    關於 Otezla,我想知道你在輕度銀屑病領域是否有任何市場份額或績效指標,特別是,你已經批准了 1.5 年。我猜你對你在那個非常不同的細分市場中所做的滲透有所了解。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes, Tim, thanks for the question. Unfortunately, the differentiation between mild and moderate is difficult because there isn't really good coding that we can use as a surrogate for determining which is which. So what we look at is what percentage of our business is being sourced from systemic-naive patients, which we infer that they are milder and that their last treatment that they've been on prior to Otezla was a topical. And 80% of our new patient growth right now is coming from the post-topical pre-systemic patient type. So we are definitely making progress.

    是的,蒂姆,謝謝你的提問。不幸的是,輕度和中度之間的區別是困難的,因為沒有真正好的編碼我們可以用作確定哪個是哪個的替代。因此,我們關注的是我們的業務有多少百分比來自系統性天真的患者,我們推斷他們更溫和,他們在 Otezla 之前接受的最後一次治療是局部治療。我們現在 80% 的新患者增長來自局部後系統前患者類型。所以我們肯定正在取得進展。

  • What we're doing right now, as I mentioned earlier, is we're scaling our promotional effort that targets where these patients are being treated, and we expect to be able to grow the volume of patients that we're securing. As you'll note, we grew the volume of Otezla in the quarter by 5%, and we expect to be able to improve on that.

    正如我之前提到的,我們現在正在做的是,我們正在擴大針對這些患者接受治療的地方的宣傳力度,我們希望能夠增加我們獲得的患者數量。正如您所注意到的,我們在本季度將 Otezla 的銷量增加了 5%,我們希望能夠在此基礎上有所改進。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Julie Anne, I know we're already at half past the hour. So that's the time that we had asked our colleagues to set aside for the call. But we have a couple of more questions in the queue. We'll try to get through those and then, as is our custom, be available if anybody has any questions for later this evening. But let's go to the next question.

    朱莉·安妮,我知道我們已經過了半點了。所以那是我們要求我們的同事留出電話的時間。但我們還有幾個問題需要等待。我們將嘗試解決這些問題,然後按照我們的慣例,如果有人有任何問題,請在今晚晚些時候聯繫我們。但是,讓我們轉到下一個問題。

  • Operator

    Operator

  • Our next question comes from Geoff Meacham from Bank of America.

    我們的下一個問題來自美國銀行的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • Murdo, of your new launched products in the past few years, EVENITY stands out as one that had a really good progression each quarter. What does the long-term opportunity here look like? And then how do you think about life cycle management of the bone franchise overall, later on as you get close to the LOE?

    Murdo,在您過去幾年推出的新產品中,EVENITY 脫穎而出,每個季度都取得了非常好的進展。這裡的長期機會是什麼樣的?然後,當您接近 LOE 時,您如何看待整個骨骼特許經營權的生命週期管理?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Geoff, for the question, and for noting the performance of EVENITY. The bone team have done an exceptional job with this product. And I think the Amgen legacy in building the Prolia franchise is clearly helping that, along with our partnership with UCB. I was just recently in Japan. And as Bob mentioned in his opening remarks, we have an ultra-aging society there. And EVENITY is doing extremely well and I would say is a really good leading indicator of what we could do in the U.S. with that product. So I think we're really early in our ability to penetrate the millions of patients that would benefit from a bone builder like EVENITY.

    是的。謝謝 Geoff 提出問題,並註意到 EVENITY 的表現。骨骼團隊在這款產品上做得非常出色。我認為 Amgen 在建立 Prolia 特許經營權方面的遺產以及我們與 UCB 的合作夥伴關係顯然有助於實現這一目標。我剛剛在日本。正如鮑勃在開場白中提到的那樣,我們那裡有一個超老齡化社會。 EVENITY 做得非常好,我想說這是一個非常好的領先指標,表明我們可以用該產品在美國做什麼。所以我認為我們真的很早就能夠滲透數百萬患者,這些患者將從像 EVENITY 這樣的骨骼構建器中受益。

  • We also see a very nice continuum of care for these patients where, let's say, you're on bisphosphonate or Prolia and you have a fracture, you go on EVENITY for 12 months, and then you return to a product like denosumab or Prolia for your continued care. So there really is a nice franchise opportunity here with both Prolia and EVENITY. And we see the addressable population as being extremely large, and we are still very early in growing that product, obviously now annualizing at over $1 billion. It's an exciting growth opportunity for us going forward. And we're as enthusiastic as we possibly could be.

    我們還看到了對這些患者的非常好的連續性護理,比方說,您正在服用雙膦酸鹽或 Prolia,並且您發生了骨折,您繼續服用 EVENITY 12 個月,然後您返回到像地諾單抗或 Prolia 這樣的產品以維持治療你的持續照顧。因此,Prolia 和 EVENITY 確實有很好的特許經營機會。我們看到可尋址的人口非常龐大,而且我們在開發該產品方面還處於早期階段,顯然現在年化收入超過 10 億美元。對我們來說,這是一個令人興奮的增長機會。我們盡可能熱情。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Julie Anne, let's take one last question, after which Bob will make some closing comments.

    Julie Anne,我們來回答最後一個問題,之後 Bob 將發表一些結束語。

  • Operator

    Operator

  • 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。

  • Dane Vincent Leone - MD & Biotechnology Analyst

    Dane Vincent Leone - MD & Biotechnology Analyst

  • As we contemplate the updated guidance for the year, probably 2 competitive questions are still curious to me on the call. Firstly, you've had a great momentum with Repatha. Earlier in the week, Novartis really highlighted Leqvio or inclisiran, finally gaining some traction in the U.S. Would love to hear your thoughts around how you view competitive dynamics in the PCSK9 class for the remainder of the year. And then secondly, kind of on a similar note, I did notice LUMAKRAS declined Q-on-Q in the first quarter in the U.S. And was just curious if you saw any impact of Krazati, the competitive agent from Mirati.

    當我們考慮今年更新的指南時,我在電話會議上可能仍然對兩個競爭性問題感到好奇。首先,你對 Repatha 的發展勢頭很好。本週早些時候,諾華公司真正強調了 Leqvio 或 inclisiran,最終在美國獲得了一些吸引力。很想听聽您對今年餘下時間 PCSK9 類競爭動態的看法。其次,有點類似,我確實注意到 LUMAKRAS 第一季度在美國的 Q-on-Q 下降了。我很好奇你是否看到了來自 Mirati 的競爭性代理 Krazati 的任何影響。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes, thanks. Maybe I'll flip the answer around. It's really too early to tell with Mirati impact. I think what I've mentioned in response to an earlier question, the actual demand volume Q-on-Q is pretty flat. What we're actually seeing in the sales is a work down of some end-user inventory from Q4 to Q1 of this year for LUMAKRAS; but actual patients treated, pretty flat quarter-on-quarter. So we're not seeing a big impact yet from Mirati. And of course, for LUMAKRAS, we're really focused on growing LUMAKRAS through additional indications and additional data to move into earlier lines of therapy, which Dave covered in his remarks.

    對了謝謝。也許我會翻轉答案。現在判斷 Mirati 的影響還為時過早。我認為我在回答之前的問題時提到過,實際需求量 Q-on-Q 非常平穩。我們在銷售中實際看到的是 LUMAKRAS 從今年第四季度到第一季度的一些最終用戶庫存減少;但實際接受治療的患者,環比持平。所以我們還沒有看到 Mirati 的重大影響。當然,對於 LUMAKRAS,我們真正專注於通過額外的適應症和額外的數據來發展 LUMAKRAS,以進入更早的治療線,戴夫在他的評論中提到了這一點。

  • As we look at Repatha, I think we really are excited about what we're seeing now. We see more and more enthusiasm from cardiologists in a broad way and in a deep way, i.e., using Repatha more frequently in their prescribing practices for ASCVD patients. What we've been doing over the course of the last, call it, 18 months, is increasing our Repatha commercial presence at primary care. And this year, we're actually making another step change in primary care promotional effort by increasing the size of our primary care sales force here.

    當我們看 Repatha 時,我認為我們真的對我們現在看到的感到興奮。我們看到越來越多的心髒病專家在廣泛和深入的方面表現出熱情,即在他們對 ASCVD 患者的處方實踐中更頻繁地使用 Repatha。在過去的 18 個月裡,我們一直在做的是增加 Repatha 在初級保健領域的商業影響力。今年,我們實際上通過增加我們這裡的初級保健銷售人員的規模,在初級保健促銷工作方面做出了又一步的改變。

  • So Repatha is very much moving in the right direction. Patients are benefiting from it. We maintain more than a 70% share of the PCSK9 class. But quite frankly, that's not what my team looks at. They look at trying to penetrate the millions of ASCVD patients, the tens of millions of ASCVD patients, that need to lower their LDL-C to below goal. And as I mentioned in my opening remarks, less than 30% of patients -- and that's not our data, that's data from the Family Heart Organization, less than 30% of patients are at their LDL-C goal. So we feel like this is important work. We feel like we've got a best-in-class medicine in Repatha. We've got great coverage, and we expect to continue to grow this product globally to serve many millions of patients over the years to come.

    因此,Repatha 正朝著正確的方向前進。患者正在從中受益。我們在 PCSK9 類中保持了 70% 以上的份額。但坦率地說,這不是我的團隊所關注的。他們著眼於試圖滲透數百萬 ASCVD 患者,數千萬 ASCVD 患者,他們需要將他們的 LDL-C 降低到目標以下。正如我在開場白中提到的,只有不到 30% 的患者——這不是我們的數據,而是來自家庭心臟組織的數據,只有不到 30% 的患者達到了他們的 LDL-C 目標。所以我們覺得這是一項重要的工作。我們覺得我們在 Repatha 擁有一流的藥物。我們的覆蓋範圍很廣,我們希望在未來幾年繼續在全球範圍內發展該產品,為數百萬患者提供服務。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Thank you, Murdo, for your response to that question. And let me again thank all of you for joining us on the call. Just a couple of quick thoughts. Obviously, we're off to a good start here in the year, as you can see from the results in the first quarter. And as I said in my opening remarks, far more important than the quarter itself is the way it's setting us up for the long term.

    好的。默多,謝謝你對這個問題的回答。讓我再次感謝大家加入我們的電話會議。只是幾個快速的想法。顯然,正如您從第一季度的結果中可以看出的那樣,今年我們開局不錯。正如我在開場白中所說,比本季度本身更重要的是它為我們的長期發展奠定的方式。

  • So if you think back to the things that we've talked about as being important for us, being able to deliver on our long-term growth strategy, it starts with our growth products having to perform. As you saw in the quarter, we had 10 brands achieving record performance. And performance means growing share, growing penetration. And as Murdo said, that's what we see happening now with our important growth driving brand.

    因此,如果你回想一下我們所討論的對我們來說很重要的事情,能夠實現我們的長期增長戰略,首先是我們的增長產品必鬚髮揮作用。正如您在本季度看到的那樣,我們有 10 個品牌取得了創紀錄的業績。性能意味著不斷增長的份額,不斷增長的滲透率。正如默多所說,這就是我們現在看到的我們重要的增長驅動品牌正在發生的事情。

  • The other thing we said is that for us to be successful over the long term, we've got to perform in the international markets. And again, I think the volume trends that you see here early in the year are really a good indicator that we're building the kinds of platforms we need to have in order to deliver long-term growth for our medicines outside the United States.

    我們說的另一件事是,為了讓我們長期取得成功,我們必須在國際市場上表現出色。再一次,我認為你今年年初在這裡看到的數量趨勢確實是一個很好的指標,表明我們正在構建我們需要的各種平台,以便為我們在美國以外的藥物實現長期增長。

  • We talked a lot about biosimilars on this call. We've said that we think it's an important contributor to our growth long term as we bring new products to market and launch them in new countries. And in order for us to do that, we need to be a leading competitor, and that means we need to execute on time and be in the first wave of launches. Once again, this quarter, you see further proof points of our being able to do that consistently with the launch of AMJEVITA, the approval of BEKEMV, et cetera. So we think competitively, we're well positioned there and a biosimilar business to capitalize on the opportunities.

    我們在這次電話會議上談了很多關於生物仿製藥的問題。我們已經說過,隨著我們將新產品推向市場並在新國家/地區推出,我們認為這是我們長期增長的重要貢獻者。為了讓我們做到這一點,我們需要成為領先的競爭對手,這意味著我們需要按時執行並參與第一波發布。在本季度,您再次看到我們能夠通過 AMJEVITA 的推出、BEKEMV 的批准等始終如一地做到這一點的進一步證據。因此,我們認為具有競爭力,我們在那里處於有利地位,生物仿製藥業務可以利用這些機會。

  • And then, of course, the pipeline is always critical. And we're excited about how our pipeline is very rapidly advancing, particularly on the registration-enabling trials, whether you look at tarlatamab or bema or rocatinlimab. We have a lot of important registration-enabling work underway, and we're excited to start generating results from those portfolio of products as well as some of the products that are now attracting quite a bit of attention like 133 and our mid-stage pipeline.

    然後,當然,管道總是至關重要的。我們對我們的管道如何快速推進感到興奮,特別是在註冊試驗方面,無論你是看 tarlatamab 還是 bema 或 rocatinlimab。我們正在進行許多重要的註冊支持工作,我們很高興開始從這些產品組合以及一些現在引起相當多關注的產品中產生結果,例如 133 和我們的中期管道.

  • So all in all, we're off to a good start in the quarter, and we remain very enthusiastic about the long term. And in the meanwhile, we're looking forward to having an opportunity to close on the Horizon transaction once regulators have completed their work. So thank you for tuning in, and we look forward to being back with all of you in August.

    因此,總而言之,我們在本季度取得了良好的開端,我們對長期發展仍然充滿熱情。與此同時,我們期待在監管機構完成工作後有機會完成 Horizon 交易。感謝您的收看,我們期待在 8 月再次與大家見面。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Great. Thanks, everybody, and we'll be around for a while. So feel free to reach out to me if you have any questions. Thanks again.

    偉大的。謝謝大家,我們會待一段時間。如果您有任何問題,請隨時與我聯繫。再次感謝。

  • Operator

    Operator

  • This concludes our first quarter full year 2023 financial results conference call. You may now disconnect.

    我們的 2023 年第一季度全年財務業績電話會議到此結束。您現在可以斷開連接。