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。
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)
我是朱莉安妮,今天我將擔任安進公司2023年第一季及全年財務業績電話會議的主持人。 (操作說明)
I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.
現在我謹介紹投資人關係副總裁阿文德‧蘇德先生。蘇德先生,您可以開始了。
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.
謝謝朱莉安妮。大家下午好,歡迎參加我們這次電話會議,共同討論我們2023年第一季的業績。
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.
強勁的銷售成長為今年剩餘時間的前景改善奠定了良好的基礎,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.
我們的董事長兼執行長鮑勃·布拉德韋將首先發表一些準備好的講話,隨後我們領導團隊的其他成員將對公司業績進行更廣泛的回顧。您應該已經收到我們發布的幻燈片連結。
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,但需要提醒的是,實際結果可能會有重大差異。
So with that, I would like to turn the call over to Bob. Bob?
那麼,接下來我想把電話交給鮑伯。鮑伯?
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,也謝謝各位參加我們的電話會議。首先,我想提請大家注意我們第一季14%的銷售成長,這說明了在考慮今年剩餘時間和未來發展時值得牢記的兩點。
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,就新冠疫情而言,我們似乎終於翻過了疫情對整個醫療保健系統影響的這一頁。例如,我們看到美國大多數專科的處方量都實現了同比增長,包括心臟病學和腫瘤學。這是一個好消息,因為它表明患者正在恢復到疫情前的就醫習慣,醫生就診再次成為適當診斷和治療的保障。這顯然對我們的藥品組合來說是個好兆頭。
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,儘管當前宏觀經濟面臨挑戰,我們看到藥品需求依然強勁。例如,Repatha、EVENITY、BLINCYTO 和 KYPROLIS 在本季均創下銷售紀錄,銷量分別成長了 33%、55%、49% 和 18%。我們認為這並非銷量成長所致,而是這些藥品以及我們產品組合中的其他藥品具有巨大的潛力,能夠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。
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.
以瑞百安(Repatha)為例。我們相信,在大多數高風險心血管疾病患者仍無法達到建議的低密度脂蛋白膽固醇(LDL)水平,或僅能短暫達到且效果不佳的當下,瑞百安蘊藏著巨大的發展潛力。全球公共衛生危機和心臟病問題要求醫療體系中的所有參與者攜手合作,共同推動改變。而瑞百安,這款經過驗證的創新產品,我們深知它能夠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.
我們最新推出的兩款藥物TEZSPIRE和TAVNEOS在美國的季度環比銷量分別成長了28%和27%。 TEZSPIRE在美國廣受過敏科醫師和肺科醫師的青睞,其近期核准的預填充注射筆為患者提供了自我給藥的選擇。在收購TAVNEOS幾個季度後,我們堅信,憑藉我們在風濕病學和腎臟病學領域的深厚經驗,我們將能夠把這款首創藥物帶給更多受益的患者。
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.
除美國以外,本季銷量成長超過20%。尤其是在亞太地區,隨著我們利用瑞百安(Repatha)和普羅利亞(Prolia)等藥物在日本和中國這兩個世界上老齡化速度最快的國家擴大服務患者群體,我們的銷量增長了近50%。
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.
安進公司本季研發投入成長了12%。這一增長反映了我們對幾款潛在首創新藥註冊審批所需臨床試驗的投入,其中包括用於治療心臟病的olpasiran、用於治療炎症的rocatinlimab以及用於治療癌症的bemarituzumab和tarlatamab。這四種藥物都體現了安進的創新精神。它們都是能夠有效對抗亟需新療法的嚴重疾病的創新分子。
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.
我們正在積極探索TEZSPIRE、BLINCYTO和LUMAKRAS的多項重要新適應症。我們期待下半年能獲得研發管線中的多項數據。
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.
我們持續大力投資早期研究,在過去的十年中,我們建立了一套差異化的能力,這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.
當全世界都在驚嘆於 ChatGPT 的強大功能時,我們早已在研究實驗室中部署了人工智慧和機器學習技術,這為我們帶來了強大的乾實驗室能力。將這些技術應用於生物製劑開發後,我們已經取得了超出預期的成功率提升和週期縮短。這的確是生物製劑創新蓬勃發展的時代。
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.
我們對已宣布的對Horizon的收購仍然保持樂觀。與我們先前對TAVNEOS的收購經驗類似,我們與Horizon團隊相處的時間越長,就越發對將安進的實力和全球影響力應用於Horizon的首創創新藥物組合及其研發管線充滿信心。
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.
對於安進的所有人來說,這是一個令人興奮的時刻。事實證明,全球對創新藥物的需求依然強勁且不斷成長,同時,我們的創新能力也達到了前所未有的高度。
Always, I'm grateful to my Amgen colleagues around the world for their commitment to patients and to our business.
我始終感謝安進全球各地的同事們對病人和我們業務的奉獻。
Now let me turn it over to Murdo.
現在讓我把麥克風交給默多。
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年開始,我們強勢推動「為全球數百萬病患帶來創新產品」的使命。第一季度,我們旗下10個品牌的銷售額均創歷史新高,其中普通內科和血液腫瘤增長型品牌銷量均實現強勁增長,抗炎治療藥物AMJEVITA成功上市,TEZSPIRE和TAVNEOS也取得了顯著增長。此外,我們先前宣布收購Horizon Therapeutics,該收購很快就會為我們的產品組合增添幾款重要藥物。
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.
第一季銷量成長14%,其中美國市場成長10%,美國以外地區成長22%。亞太地區持續維持成長最快勢頭,本季銷量成長47%。剔除匯率影響,第一季全球產品銷售額成長4%。計入2%的匯率負面影響,產品銷售額年增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.
首先來看我們的普通藥物業務,其中包括瑞百安(Repatha)、普羅利亞(Prolia)、依維寧(EVENITY)和愛莫維(Aimovig)。這四款產品第一季的總營收年增13%,主要得益於銷售量成長19%。心血管疾病正日益成為一個嚴峻的危機。
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,平均每40秒就有一人發生心臟病發作或中風。然而,高風險動脈粥狀硬化性心血管疾病(ASCVD)患者,尤其是低密度脂蛋白膽固醇(LDL-C)水平升高的患者,其醫療照護狀況卻令人震驚地很糟糕。我們最近發布了來自FH基金會的一項研究,該研究涵蓋了3800萬高風險美國人,結果顯示,其中只有不到30%的人達到過建議的LDL-C水平。這些數據凸顯了像Repatha這樣的療法對於滿足這項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.
我們很高興看到越來越多的患者受益於瑞百安(Repatha)。第一季銷售成長33%,帶動銷售額成長18%,價格下跌速度也放緩,降幅小於去年同期。在美國,銷售量成長32%主要得益於心臟科醫師廣泛採用瑞百安以及初級保健醫師對該藥的接受度不斷提高。在美國以外地區,銷售成長34%,國際業務發展勢頭強勁。
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.
顯然,在應對這場心血管健康危機方面,我們還有更多工作要做。今年三月,我們在美國心臟病學會召開了首屆年度低密度脂蛋白膽固醇(LDL-C)行動高峰會,旨在透過制定策略和提供解決方案,改善高風險動脈粥狀硬化性心血管疾病(ASCVD)患者的血脂管理,從而探討美國心血管疾病治療的現狀。透過加強降低LDL-C水平,心血管疾病治療領域的領先利益相關者與安進公司攜手合作,共同朝著一個宏偉的目標邁進。我們的目標是到2030年將美國的心血管事件數量減半。我們相信,瑞百安(Repatha)將在實現這一目標的過程中發揮重要作用。
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.
向骨骼健康領域轉型。 Prolia 第一季銷售額年增 9%,主要得益於銷量成長 8%。 EVENITY 是我們骨骼產品組合中與 Prolia 互補的產品,該季度銷售額創下 2.54 億美元的新紀錄,主要得益於各市場銷售的強勁增長。
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.
現在來說說我們的發炎治療產品組合。 Otezla 的銷量在本季度增長了 5%。由於庫存水準下降以及患者和支付方結構變化導致的價格下跌,銷售額比去年同期下降了 13%。此外,我們還提供了額外的折扣以提高醫療保險覆蓋範圍。我們在美國 Otezla 業務的成長受到了新上市的局部用藥和全身用藥競爭對手的免費藥物計劃的影響,我們預計這些計劃將在 2023 年繼續影響新患者的需求。
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,鑑於 Otezla 已確立的療效和安全性、強大的醫保覆蓋範圍(包括有限的預先授權要求)以及便捷的給藥方式,我們認為其具有強勁的增長潛力。 Otezla 仍然是目前唯一獲準的適應症廣泛的口服系統性治療藥物,能夠幫助超過 150 萬美國初治輕度乾癬患者,這些患者無法透過局部用藥獲得最佳療效,但可以從 Otezla 等系統性治療中獲益。
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.
在美國,恩利(Enbrel)的銷量在本季成長了1%,這主要得益於健保覆蓋範圍的擴大。在評估恩利本季的業績時,需要考慮以下幾個重要因素:全球銷售額年減33%,主要原因是淨售價下降、庫存水準較往年降低,以及與前期相關的銷售預估扣減調整帶來的9%的不利影響。展望未來,我們預計2023年全年銷售量將維持低個位數成長,淨售價年減幅將有所收窄,庫存水準也將逐步回升。
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的上市進展順利,第一季銷售額達9,600萬美元,主要得益於美國過敏科醫師和肺科醫師的積極推廣。 TEZSPIRE獨特的差異化特性使其具有廣闊的治療潛力,可望用於治療全球250萬重度未控制氣喘患者,且不受任何表型和生物標記的限制。第一季度,美國食品藥物管理局(FDA)批准TEZSPIRE以預先填充一次性注射筆的形式用於患者自我給藥,為患者提供了在家自行給藥的便捷選擇。這提高了TEZSPIRE的可及性,並為美國所有患者提供了更靈活的治療方案。
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.
第一季TAVNEOS的銷售額為2,300萬美元。美國市場銷售量較上季成長27%,主要得益於新患者數量的增加。目前,美國已有超過1700名患者接受了TAVNEOS治療,這印證了我們先前的判斷:安進在發炎和腎臟病領域的深厚經驗以及強大的市場影響力,使我們能夠為更多ANCA相關性血管炎患者提供TAVNEOS。
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作為首個在美國上市的Humira生物相似藥正式面世。 Humira是一種用於治療超過100萬嚴重發炎性疾病患者的藥物。本季度,我們看到了首批患者處方已完成配藥,並且我們對胃腸病學家和風濕病學家對AMJEVITA的高度認知感到鼓舞。憑藉我們在生物製劑研發和生產方面的卓越成就以及數十年來在發炎領域的經驗,安進擁有獨特的優勢,能夠利用這款生物相似藥為患者提供治療。展望未來,我們預計第二季度AMJEVITA在美國的銷售額將低於第一季度,因為第一季AMJEVITA在美國的銷售額主要來自庫存補充。
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.
接下來談談我們的血液腫瘤業務,其中包括LUMAKRAS、KYPROLIS、XGEVA、Vectibix、Nplate和BLINCYTO。這六款創新產品的銷售額和銷量在本季年增21%,KYPROLIS和BLINCYTO的季度銷售額均創歷史新高。血液腫瘤業務的成長得益於重要的新臨床數據。 BLINCYTO在第一季的銷售額成長了41%,這主要得益於學術機構和社區醫療中心的大力推廣,而這又得益於2022年12月公佈的註冊依據性E1910研究的積極數據。
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.
受銷量成長15%的推動,Vectibix第一季銷售額年增16%,這主要得益於III期PARADIGM試驗的正面數據,該試驗顯示Vectibix聯合化療優於貝伐珠單抗。 KYPROLIS持續保持強勁成長勢頭,本季銷售額成長25%,其中銷量成長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第一季銷售額達7,400萬美元,年增19%,主要得益於銷售量成長40%,但部分被淨售價下降抵銷。除了美國外,LUMAKRAS已在50個國家獲得批准,我們正積極開拓30多個市場,並努力爭取在其餘國家獲得健保報銷。
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.
受淨售價下降的影響,我們腫瘤生物相似藥第一季的銷售額年減了27%。儘管我們用於治療MVASI和KANJINTI的生物相似藥在美國市場佔據領先地位,但我們預計,在競爭加劇的情況下,淨售價將持續惡化,銷量下滑速度也將加快。從長遠來看,我們預期生物相似藥業務的長期成長將主要得益於新分子的加入和更多產品的上市。
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.
鑑於我們血液腫瘤產品組合的強勁表現,以及 BLINCYTO 和 Vectibix 近期取得的積極數據,再加上我們腫瘤產品線中 LUMAKRAS 的持續臨床開發,我對該產品組合未來的成長潛力充滿期待。
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.
2023 年第一季即將結束,我對我們在美國和國際市場的業務組合的強勁執行力感到滿意。
And with that, I'll turn it to Dave.
接下來,我將把麥克風交給戴夫。
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 Murdo,大家下午好。研發方面,上個季度我們有效率執行,推動了多項創新產品線的註冊相關研究,各項進展順利。在一般醫學領域,我們專注於推進了心血管產品線和新興的肥胖症藥物組合的臨床實施。
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.
我們先來說說奧帕司坦。針對動脈粥狀硬化性心血管疾病的III期臨床結局研究進展順利。今年3月,我們公佈了更多數據,顯示奧帕司坦能夠顯著降低動脈粥狀硬化性心血管疾病患者(其Lp(a)濃度高於150納摩爾/公升)的Lp(a)濃度,且此降低效果不受基線水平的影響。
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.
我們還與黑人心臟病專家協會和莫爾豪斯醫學院合作啟動了「非裔美國人心臟研究」。這項研究將測量5,000名非裔美國人體內Lp(a)與動脈粥狀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)的研究主要集中在歐洲裔族群。我們正在進行“非裔美國人心臟研究”,以彌合這一研究空白。
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.
接下來談談肥胖症。我們正快速啟動一項針對肥胖症患者(無論是否患有糖尿病及相關合併症)的 AMG 133 II 期臨床試驗。該試驗將探索不同的劑量水平和治療方案,其總體目標是獲得數據,從而為設計能夠實現強效且可持續減重的 III 期臨床試驗方案提供廣泛的選擇。
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.
針對肥胖症中非腸促胰島素路徑的小分子藥物AMG 786正在進行I期臨床試驗,目前正在招募病患。此外,多種作用機轉與GLP-1或GIPR療法不同的臨床前分子藥物也正在推進臨床試驗階段。
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.
在發炎領域,除了重度氣喘之外,我們正在利用TEZSPIRE探索多種其他適應症,包括針對伴隨鼻息肉的慢性鼻竇炎和嗜酸性食道炎的獨立III期研究。我們還有兩篇II期研究,一篇針對慢性自發性蕁麻疹,另一項針對慢性阻塞性肺病(COPD)。慢性自發性蕁麻疹研究已完成,預計2023年中期公佈初步數據。
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.
慢性阻塞性肺病(COPD)臨床試驗已完成全部受試者招募,涵蓋了廣泛的COPD患者群體,包括嗜酸性粒細胞計數高低不同的患者。現有證據表明,TSLP參與了包括COPD在內的慢性發炎性疾病,並且可能是導致COPD患者病情嚴重加重的關鍵因素。我們期待在2024年上半年獲得該研究的結果。
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.
針對中度至重度異位性皮膚炎患者,目前正在研究一種潛在的首創抗OX40單株抗體-rocatinlimab,其ROCKET III期臨床開發計畫的招募工作已取得良好開端。該計畫包含7項研究,旨在評估rocatinlimab在廣泛的異位性皮膚炎患者群體中的安全性和有效性,這些患者包括未接受過生物製劑治療、接受過生物製劑或JAK抑制劑治療的患者,以及不同種族群體和青少年。我們也正在測試不同的給藥方案,包括每月一次或更低頻率的給藥方案。
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公司報告了TEPEZZA IV期臨床試驗中具有統計學意義和臨床意義的主要結果。如FDA修訂後的藥品標籤所述,TEPEZZA適用於治療甲狀腺眼疾,無論臨床活動評分或病程長短。羅氏巴福司α和依伐白介素α治療系統性紅斑狼瘡的IIb期研究因療效不佳而終止。這些研究採用了新型的適應性設計,使我們能夠更快、更經濟高效地產生決策數據。
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.
系統性紅斑狼瘡(SLE)仍然是藥物研發領域的一大挑戰,我們將持續關注這一領域,並進一步探索相關數據集,以增進我們對該領域的了解。除了我們現有的研發管線外,我們期待在交易完成後將Horizon公司的分子納入研發,從而進一步加強我們應對發炎性疾病的力度。
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.
在腫瘤學領域,我們計劃於2023年下半年向全球監管機構提交E1910的上市申請,並進行一項由ECOG ACRIN合作組牽頭的III期臨床試驗。本試驗旨在證明,在微小殘留病灶(MRD)陰性的初診B細胞急性淋巴性白血病(ALL)成人患者中,在標準鞏固化療方案中加入BLINCYTO可顯著提高總存活期。除此項研究外,我們還將加大投入,致力於將BLINCYTO應用於更早期的治療方案,並透過皮下給藥提高患者的用藥便利性。
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,旨在比較靶向 DLL3 的 tarlatamab 分子與標準化療方案在二線小細胞肺癌治療中的療效,該研究將於本月啟動。我們預計將於 2023 年下半年公佈一項潛在的註冊性 II 期研究的頂線數據,該研究評估 tarlatamab 在既往接受過大量治療的小細胞肺癌患者中的療效,這對於小細胞肺癌患者而言可能是一個重要的里程碑。
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LUMAKRAS的新型聯合療法。 LUMAKRAS合併Vectibix治療第三線大腸直腸癌的III期臨床研究已完成全部患者入組,預計將於2023年下半年公佈數據。我們計畫啟動LUMAKRAS合併化療治療第一線PD-L1陰性非小細胞肺癌患者的III期臨床研究。
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會議上,我們將發表LUMAKRAS合併標準化療治療非小細胞肺癌以及合併Vectibix和標準化療治療大腸直腸癌的研究數據。此外,我們已完成LUMAKRAS CodeBreak 200研究資料以及II期劑量比較子研究資料的提交,提交對象包括美國FDA和歐洲藥品管理局(EMA)。
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.
對於針對STEAP1的雙特異性抗體AMG 509(現更名為xaluritamig),我們已確定了其標靶劑量,並正在晚期前列腺癌患者中進行單藥治療擴展隊列研究。我們期待在2023年下半年分享初步數據。
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.
為了進一步豐富我們的生物相似藥產品組合,我們欣然宣布,歐盟委員會已批准我們的SOLIRIS生物相似藥BEKEMV上市。 BEKEMV是第一個獲得歐盟委員會批准的SOLIRIS生物類似藥,目前僅獲準用於治療成人和兒童陣發性睡眠性血紅蛋白尿症(PNH)。 PNH是一種罕見的、危及生命的骨髓疾病。我們已向美國食品藥物管理局(FDA)提交了該產品的美國生物製品許可申請(BLA)。
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,一項旨在支持美國對 AMJEVITA 進行互換性認定的 III 期轉換研究,採用的是 AMJEVITA 的試驗性高濃度製劑,該研究達到了其主要終點,即主要藥物動力學終點的相似性。
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,我要感謝安進公司世界各地的員工,感謝他們堅持不懈地專注於執行,並努力滿足我們所服務患者的需求。
I'll now turn things over to Peter.
現在我把事情交給彼得。
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.
謝謝戴夫。我們對目前的執行情況感到滿意,並有望實現2023年全年及更長期的目標,這主要得益於包括Repatha、EVENITY、BLINCYTO、TEZSPIRE和TAVNEOS在內的多款產品銷量強勁增長14%。在推進後期研發管線並努力在6月底前完成對Horizon的收購的同時,我們將繼續投資以實現長期成長。
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2023年業績展望之前,我將先回顧我們第一季的業績。需要提醒的是,這些業績和展望反映的是安進公司獨立運營的情況,並未對已宣布的Horizon收購案進行任何調整。
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.
接下來看一下我們第一季的財務業績,詳見投影片第38頁。總收入為61億美元,較去年同期下降2%。然而,若剔除匯率波動帶來的2%負面影響,產品銷售額成長4%,總營收與2022年第一季持平。這4個百分點的差異是由於預期中其他收入的下降,原因是與禮來公司在新冠疫情合作中利潤和成本分攤減少。
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.
由於福利計劃變更、保險重新核實以及自付費用增加,第一季產品銷售額通常佔全年銷售額的百分比最低。第一季度,受銷售成長14%的推動,產品銷售額年增2%,但部分被淨售價下降5%、預期銷售扣減額不利變化3%、庫存水準下降2%以及前文提及的匯率波動2%的影響所抵銷。
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.
第一季非GAAP營運總支出年增6%,主要受研發投入增加所致。本季非GAAP研發支出年增12%,其中後期專案支援、探索性研究、早期管線及上市產品支援方面的支出增加。
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較去年同期上升0.8個百分點至17.4%,主要原因是產品組合變動和利潤分成費用增加。需要注意的是,第一季的銷售成本受到先前已計入存貨的1.25億美元波多黎各消費稅的一部分的影響,剩餘部分的影響預計將在第二季顯現。
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.
第一季非GAAP銷售、管理及行政費用年增1%。我們持續專注於優先進行關鍵投資、推動數位轉型並提升生產力。非GAAP經營收益及權益受惠於利息收入增加,以及因回購部分債務組合而獲得的約1.1億美元去槓桿收益。此外,我們已對在百濟神州的投資進行市值計價,並將影響力計入GAAP損益表。第一季度,這導致僅以GAAP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,我們第一季的非GAAP稅率上升了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更,該變更從2023年開始以所得稅取代了消費稅,以及我們現有稅務準備金的利息支出增加。
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.
我們始終堅持既定的資本配置優先事項。首先,我們將繼續投資於推動長期成長的內部和外部創新。 2023年第一季度,我們非GAAP研發支出較2022年第一季度增長12%,加之我們收購了TAVNEOS以及已宣布收購Horizon Therapeutics,這些舉措將進一步拓展和強化我們的一流和同類最佳療法產品組合,從而惠及全球更多患者。
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,我們持續投資於業務發展,以促進長期成長。由於我們在俄亥俄州和北卡羅來納州同時建造最先進的製造工廠,資本支出已接近高峰。我們預計,隨著俄亥俄州工廠的竣工和獲得許可,自2024年起,年度資本支出將有所下降。
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,我們繼續向股東返還資本,第一季每股派發股利2.13美元。這比2022年前四個季度每季派發的股息都成長了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%.
本季自由現金流下降主要受銷售、返利和激勵措施的時間表、營業收入減少以及在北卡羅來納州和俄亥俄州建設先進設施的資本支出增加的影響。我們預計今年剩餘時間現金流將保持強勁,與我們2023年全年財務展望一致,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.
我們預計第二季度自由現金流將環比增長,但由於 Horizon 收購融資和預計交易成本中某些項目的會計處理,以及我們之前在第一季度宣布的重組,預計 Horizon 收購的完成可能會對第二季度和自由現金流產生影響。
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.
請參閱第40頁投影片,以了解2023年的業務展望。我們目前的業績指引僅針對安進獨立業務,不包含任何Horizon預測。我們上調了2023年的業績指引。我們將2023年營收指引上調至262億美元至273億美元,高於先前的260億美元至272億美元。這反映了我們對公司基本業務的信心,以及鮑勃和默多提到的,患者獲取我們藥物的整體市場環境正在改善。此外,我們將2023年非GAAP每股盈餘指引上調至17.60美元至18.70美元,高於先前的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.
在您建立2023年剩餘時間的績效模型時,我再補充幾點重要的考量。產品銷售方面,我們預期產品組合整體銷售量將穩健成長,與第一季持平。我們預計2023年產品組合價格將出現中等個位數的下降。我們目前預計Neulasta全年銷售額約為7億美元,KANJINTI和MVASI全年合併銷售額約為8.5億美元。我們預計全年非GAAP營運費用將比上年成長約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%,第二季營業利潤率也約為50%。同時,我們預期銷售成本(佔產品銷售額的百分比)將在16%至17%之間;2023年非GAAP研發費用將保持不變,預計同比增長3%至4%;受我們持續推進數位轉型、持續改進和提高生產力等因素的影響,非GAAP銷售、管理及行政費用(佔產品銷售額的百分比)將同比略有下降。
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營業收入及支出(OI&E)將在12億至13億美元之間,這反映了第一季與我之前提到的債務回購相關的去槓桿化,剩餘的營業收入及支出將平均分攤到接下來的三個季度。我們預計非GAAP稅率為18%至19%。我們計劃繼續大幅提高股利。我們仍預期2023年股票回購額不會超過5億美元。我們2023年的資本支出指引維持不變,約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長期成長充滿信心。我們期待完成先前宣布的對Horizon的收購。交易完成後,我們將視情況提供更新的績效指引。
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,他們每天都在為我們的患者和未來的患者執行任務。
That concludes the financial update. I'll turn it over to Bob for Q&A.
財務報告到此結束。接下來交給鮑伯回答問題。
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,可以提醒一下聽眾提問的流程嗎?我知道他們今天已經很忙了,所以請他們每人只提一個問題,我們會盡力回答每位聽眾的問題。
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薩爾文·里希特。
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,您重點介紹了其廣泛的臨床項目。鑑於我們預計今年和明年將獲得II期臨床試驗數據,您能否談談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,該你了。
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,Salveen。我們正在研究的所有適應症都與慢性自發性蕁麻疹(部分由嗜酸性粒細胞驅動的疾病,嗜酸性粒細胞性食道炎也是如此)的機制有關。鑑於TSLP抑制劑的作用機制,這正是我們研究這些適應症的起點。
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.
正如我之前簡要提到的,以慢性阻塞性肺病(COPD)為例,越來越多的證據表明,病毒感染、煙霧、污染物顆粒等誘發因素可以觸發支氣管上皮細胞釋放TSLP。這與COPD患者痰液、支氣管肺泡灌洗液和支氣管粘膜中TSLP水平升高的數據相符。正如我之前提到的,該試驗已完成全部受試者招募。考慮到我們希望在這些患者身上觀察到的治療持續時間,我們預計將在明年上半年獲得數據結果。所以我認為這方面有充分的機制基礎。我們目前正處於臨床試驗執行階段,並期待數據結果的公佈。
Operator
Operator
Our next question comes from Michael Yee from Jefferies.
下一個問題來自傑富瑞集團的麥可葉。
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?
順著這個思路,也許對大衛來說,我覺得有趣的是,你們顯然已經掌握了AMG 133的肥胖數據,現在又把重點放在了AMG 786。而且我認為它現在已經開始招募和治療患者了。您能談談您為什麼對此感到興奮嗎?這之間是否存在協同效應?考慮到目前肥胖領域的種種進展,AMG 786有什麼特別值得關注的地方嗎?
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。麥克,我認為你最後說的話非常重要,就目前肥胖問題而言,這一點至關重要。如果我們稍作思考,就會發現這個問題有多嚴重,全球現在有數億肥胖患者。我們正在21世紀進行一項前所未有的實驗—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.
現在回想一下肥胖症,它雖然是一種疾病,但顯然是一種複雜的異質性疾病。毫無疑問,其中蘊含著不同的患者群體,不同的患者可能受益於不同的療法。這種疾病根植於人類演化,如今又受到環境的影響。因此,我們針對133號化合物以及後續分子的研發計劃,旨在充分利用肥胖症患者群體龐大這一事實。我認為這是一個尚處於起步階段的領域,我們有機會利用我們行業領先的多組學分析資料庫,幫助界定哪些患者群體能夠從特定的療法中獲益。我們計劃在這些研發項目中積極運用該資料庫。
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,我最後想就此補充一點。它的作用機轉並非基於腸促胰素。我認為這也是藥物研發的一個非常有前景的領域,也是我們目前臨床前研究的重點。感謝您的提問。雖然現在還處於早期階段,但我們認為這是本世紀公共衛生領域面臨的重大挑戰之一。
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.
今天我看到的一些數據讓我有點困惑。比如說,大家都知道艾伯維的修美樂(Humira)推出了生物相似藥,而你們是負責上市的。艾伯維報告稱,修美樂的銷量較去年同期下降了26%。我不明白的是,為什麼恩利(Enbrel)的銷量年減了33%,比推出生物相似藥的公司下降的幅度還要大。我認為這可能與庫存問題有關,而且我越想越覺得這個問題相當嚴重。例如,恩利的銷量下降了21%,奧特茲拉(Otezla)的銷量下降了28%,這幾乎相當於三週的銷量下降。我通常認為渠道的總庫存大約是三週的量。所以我很想知道原因。
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,Umer。你抓住了部分事實。讓我具體談談恩利(Enbrel)的情況。首先,本季銷量成長了1%。因此,恩利銷售表現的領先指標都相當不錯。這得益於市場對該產品強勁的需求、高品質的執行以及今年1月新增的藥品福利目錄。所以我們預計2023年全年銷售量將持續維持個位數低成長。這些都是衡量該產品銷售表現的高品質領先指標。
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.
正如您所指出的,庫存部分確實相當可觀。這主要是由於批發商和專科藥房的庫存水準下降所致。我認為部分原因在於銷量有所成長,但本季也出現了相當大的減量。我們預計庫存水準將在年內恢復正常。
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.
最後,Enbrel 價格調整還包括一項期外調整,這是一項不利調整,幅度約為 9%,與前期價格相關。這主要是由於各州醫療補助計劃的調整以及其他一些前期價格調整。
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.
總的來說,恩利(Enbrel)的領先指標依然良好,預計全年銷量將保持在個位數低位,並且為了贏得醫保目錄,價格方面也做出了一些讓步。此外,本季另外兩項重要因素——庫存和前期調整——也預計在年內得到改善。
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,或許我可以快速插一句,前期調整,我的意思是,那是預計銷售額扣除調整。
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。所以為了澄清這一點,正如默多所說,我們也在觀察這方面的年比價格下跌速度是否放緩。因此,我們認為目前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。前一時期很大一部分也屬於公共衛生服務(PHS)範疇。鑑於我們為PHS患者開展的項目,我們預計這部分影響在全年都會降低。
Operator
Operator
Our next question comes from Chris Raymond from Piper Sandler.
我們的下一個問題來自Piper Sandler公司的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.
我有一個關於生物相似藥業務的問題。我不確定我是否聽得清楚,但根據Murdo的評論,考慮到你們之前提到的庫存增加,AMJEVITA的收入似乎主要集中在前期。我知道你們不提供季度層面的詳細數據,但能否談談今年剩餘時間的展望,尤其考慮到你們在這個領域還有很多其他生物相似藥即將上市。另外,從策略角度來看,鑑於AMJEVITA的預期有所下調,你們似乎仍然非常重視SOLIRIS、EYLEA和STELARA的上市。能否解釋一下為什麼這些藥物的預期不會像AMJEVITA那樣下調?
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,謝謝你的提問,克里斯。具體到AMJEVITA,第一季的大部分收入來自我們所謂的“預購”,主要來自整合醫療網絡(IDN)。因此,我們很難看出這些預購收入中有多少最終轉化為實際的處方量。所以我們保守估計,大部分收入仍然是預購收入,基於此,第二季的收入可能會低於第一季。這就是我們對AMJEVITA的預估。顯然,我們目前還處於產品上市的早期階段。我們正在逐一醫生、逐一患者建立市場需求。而且,由於部分IDN的推廣活動可能不會與IQVIA等公司分享數據,因此我們無法直接看到這些推廣活動的實際效果。以上就是AMJEVITA的情況。
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.
但整體而言,安進在生物相似藥的研發方面取得了巨大的成功。我們對迄今為止所取得的成就感到非常滿意,我們成功研發出的分子均已率先或率先上市。我們將繼續致力於成為目標生物相似藥產品的首批或首批上市產品。由於全球生產和供應鏈同事的辛勤工作,我們得以持續供貨。我認為,當我們與機構客戶、支付方和醫療服務提供者接洽時,他們對安進品牌及其生產的生物相似藥都抱有很高的信任度。
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.
最後但同樣重要的是,我們堅信,到本十年末,我們的生物相似藥業務銷售額將實現2021年翻倍的目標,也就是收入將超過2021年的兩倍。我們認為,透過持續推出藥房福利和醫療福利的生物相似藥,我們將能夠實現這一目標。但大部分成長將由醫療福利生物類似藥推動。因此,醫療福利生物相似藥仍然是我們業務的重要組成部分,從事這部分工作的員工將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,我們經營這項業務的效率非常高,而且我們認為,從這項業務產生的現金流來看,我們正在為股東帶來可觀的回報。所以,為了在生物相似藥領域繼續取得成功,我們需要有效率地執行。正如你在本季度看到的,BEKEMV 的進展以及 AMJEVITA 的上市,都表明我們正按計劃推進生物相似藥業務。我再次重申,我們認為,我們透過這些投入為股東帶來了可觀的回報。
Operator
Operator
Our next question comes from Mohit Bansal from Wells Fargo.
下一個問題來自富國銀行的莫希特·班薩爾。
Mohit Bansal - Senior Equity Analyst
Mohit Bansal - Senior Equity Analyst
My question is also related to biosimilars. 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.
我的問題也與生物相似藥有關。鑑於目前看來Humira的需求並沒有明顯增長,而且您對下一季的評價也暗示其上市速度可能會比較緩慢,您認為這是否意味著你們正在失去先發優勢?或者說,明年AMJEVITA是否有可能在健保目錄中獲得優先地位,而不是僅僅達到與原廠藥同等的水平?因為目前看來,光是達到同等級似乎還不夠。
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,謝謝你的提問,Mohit。我認為我們確實充分利用了先發優勢,尤其是在整合醫療網絡(IDN)管道方面。最初的市場成長主要將來自那裡。我認為我們與其他擁有阿達木單抗(Humira)生物相似藥的生物相似藥生產商的不同之處在於,我們能夠非常有效地涵蓋風濕病學和胃腸病學領域的客戶群體,我們部署了醫療和銷售團隊,他們目前正在積極開展工作,提高人們對AMJEVITA的認知度和需求。
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,我想說,鑑於我們在三大藥品福利管理機構(PBM)中擁有同等的准入管道,我們完全有能力推動AMJEVITA的銷售。我們之前已經明確表示,這款產品的推廣將是一個循序漸進的過程。而且我們認為,我們已經充分利用了領先競爭對手的時間,有效地建立了市場需求。
Operator
Operator
Our next question comes from Jay Olson from Oppenheimer.
我們的下一個問題來自奧本海默公司的傑伊·奧爾森。
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?
我對Otezla很感興趣,想了解您預計其價格在今年內將如何變化,尤其是在TYK2目前主要由三種藥物組成的情況下。您預計在過渡到TYK2並面向付費用戶後,Otezla的價格將如何變化?
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。我們感到滿意的是Otezla的廣泛覆蓋範圍。我們的覆蓋範圍非常好。今年年初,隨著United Optum Part D計劃的上線,我們確實增加了覆蓋範圍。因此,今年價格上會有一些優惠。除此之外,我們2023年的覆蓋範圍穩定良好,並且我們期待在2024年也能保持這種狀態。所以我認為價格不會再進一步下降。事實上,我們認為你在第一季看到的負面價格影響會在第二季及以後有所緩解。所以整體而言,價格非常穩定。
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.
您提到的一點很有意思,就是競爭對手推出的免費贈品計畫。我認為這目前確實對市場造成了一定的干擾。這可能導致我們新患者的需求略有疲軟。我們大約 80% 的新患者增長來自那些之前未使用過全身性藥物的局部用藥患者,他們將 Otezla 作為首個全身性藥物。我認為,當市場上有免費贈品計劃時,這些免費贈品有時會成為處方醫生嘗試新藥的便捷途徑。我認為這正在蠶食我們以往所見的新患者成長。我相信,一旦這些競爭對手達成市場准入協議,情況就會有所不同,而這很可能在 2024 年產生影響。
Operator
Operator
Our next question comes from Colin Bristow from UBS.
下一個問題來自瑞銀集團的柯林布里斯托。
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?
好了,Murdo,你現在已經掌握了TEPEZZA的長期數據。我想問你對此有何看法?這是否會改變你對市場機會規模的看法?另外,關於LUMAKRAS,我還有一個簡短的問題:本季業績疲軟有多少是因為淨定價以及來自Mirati的競爭造成的?
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。或許我可以花點時間專門講TEPEZZA,因為電話會議上有不少分析師可能不太了解甲狀腺眼疾患者的治療流程。這一點很重要,因為它直接影響TEPEZZA的需求模式。 Horizon團隊追蹤TEPEZZA療效的方式是查看病患登記表,也就是甲狀腺眼疾患者開始使用TEPEZZA的初步申請。之後,病患登記表需要經過支付方的預先授權流程,這可能需要相當長的時間,最長可達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.
接下來,你需要安排病人的首次輸液。甲狀腺眼疾的情況與腫瘤科不同,腫瘤科的臨床腫瘤科醫師分佈相對均勻,遍布全國各地,可以進行輸液給藥。甲狀腺眼疾的治療資源較為集中。因此,患者需要一段時間才能被轉診到適當的治療地點接受首次TEPEZZA輸液。這也增加了治療時間。
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,在追蹤我們關注的早期領先指標——患者登記表——時,需要注意的是,從患者登記表提交到首次輸注之間存在相當大的滯後。這一點非常重要,尤其是在觀察病患登記表數量是否持平,或像現在這樣,TEPEZZA 的需求有所增長時。這些成長需要一段時間才能轉化為淨銷售額。以上就是我的前言。
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,正如戴夫所說,我們對最近公佈的慢性病數據感到非常興奮。我衷心祝賀整個Horizon團隊,他們出色地完成了這項高品質的試驗,證明了TEPEZZA能夠使更多臨床活動評分較低的患者受益,並真正凸顯了此類患者慢性病護理的必要性。我認為這是一項了不起的成就。我認為同時進行的標籤變更也反映了監管機構對該產品及其治療該疾病的有效性的認可。
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.
我認為,Horizon團隊在過去幾個月投入了大量時間來拓展其商業能力和醫療能力。他們完全有能力將這些已獲批准的新數據推廣給醫療服務提供者和支付方,從而幫助擴大該產品在美國的使用。因此,我們對TEPEZZA的未來成長非常樂觀。
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.
當然,我們這邊也非常興奮,一旦完成這項交易,就能在全球其他市場推出TEPEZZA。鑑於過去幾年我們一直在全球擴展安進的業務,我們擁有相應的能力、架構和規模。因此,我們已經做好了充分的準備。我們將與Horizon緊密合作,確保TEPEZZA在未來擁有多元化的發展機會。
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.
關於LUMAKRAS,簡單來說,我們去年第四季的庫存確實略有增加。因此,同比數據——或者更準確地說,是環比數據——更多地反映了庫存到貨的情況。實際需求從第四季到第一季基本持平。所以,儘管面臨市場競爭,我們依然保持了相當不錯的業績。
Operator
Operator
Our next question comes from Yaron Werber from TD Cowen.
下一個問題來自 TD Cowen 公司的 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.
我是Brendan,替Yaron發言。再問一個簡短的問題,關於TEZSPIRE的後續研究,特別是關於慢性自發性蕁麻疹(CSU)的研究。您能否大致談談您對今年中期數據公佈的預期?我們了解到,肥大細胞是CSU的關鍵致病因子之一。如果TSLP是一個更廣泛的靶點,您認為它在疾病進程中會發揮怎樣的作用?我們想了解兩者的相對定位,並評估一下對II期資料的預期。
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。你看,試驗已經全部招募完畢。我們正在收集數據。我想幾個月內我們就能拿到資料集了。我已經從機制中闡述了為什麼TSLP作為上游訊號路徑之一,如果抑制它,就可能成為治療這種疾病的有效方法。現在,我認為關鍵就在於收集資料集。
Operator
Operator
Our next question comes from Evan Seigerman from BMO Capital Markets.
下一個問題來自 BMO 資本市場的 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 [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?
關於 Otezla,我們已經注意到幾個季度以來一直存在需求方面的問題。從商業角度來看,您能否採取一些措施來加速成長,尤其是在目前免費藥品計劃(免費商品計劃)的影響下?或者我們真的需要等到明年該計劃的力度減弱後,才能看到該品牌出現更多成長?
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,我們在市場上投入了大量精力。事實上,我們已經擴大了推廣範圍,納入了更多基層醫療目標群。因為目前接受局部治療的輕症患者(約150萬)是一個龐大的潛在患者群體,他們目前由基層醫生診治,不像中重度患者那樣經常被轉診到皮膚科醫生。所以我們擴大了在基層醫療領域的覆蓋範圍,並且確實看到了基層醫療目標群的成長。
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.
我們目前看到一些壓力,尤其是季度環比壓力,主要來自治療病情更複雜的患者的高端皮膚科診所。而一些新型藥物的試用也正是在這些診所進行的。所以我認為這種情況會隨著時間的推移而趨於穩定,但這需要一年的大部分時間。我們將繼續擴大在基層醫療機構的業務,同時也努力拓展輕度至中度銀屑病患者的直接銷售管道。這些患者可能正在使用外用藥物,但由於乾癬症狀(無論是手部、臉部、頭皮或其他部位)仍然存在,他們希望徹底解決這些症狀。
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.
總的來說,我們正在投入大量資源到市場,以促進我們在生物製劑初治或系統性治療不足的輕症患者群體中的成長。我們預計,這將有助於我們在今年內拓展新患者群體,並期待Otezla在未來多年保持良好的成長動能。
Operator
Operator
Our next question comes from Robyn Karnauskas from Truist Securities.
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?
這裡是妮可,替羅賓發言。您能否幫我們分析一下Neulasta產品線,以及在市場上存在擁有自動注射器和其他裝置的生物類似藥競爭對手的情況下,安進計劃如何維持市場份額?未來我們會面臨多大的壓力?我們該如何看待Neulasta產品線?
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.
謝謝妮可的提問。說實話,我們對Neulasta系列產品迄今的業績非常滿意。我們成功保住了銷售量。當然,為了做到這一點,我們不得不做出一些價格讓步。預充式註射器的銷量也面臨一些壓力。我對Neulasta Onpro設備的表現非常滿意,我們保持了相當可觀的市場份額。我們認為今年已經簽訂了良好的合同,如果競爭對手推出與現有產品不同的產品,我們將繼續與他們競爭。但正如我們之前提到的,我們預計價格方面仍將面臨一些壓力。總的來說,我認為Neulasta團隊做得非常出色。
Operator
Operator
Our next question comes from Gregory Renza from RBC Capital Markets.
下一個問題來自加拿大皇家銀行資本市場的格雷戈里·倫扎。
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?
恭喜本季業績。羅伯,在電話會議開始時,您談到了研發方面,我記得您提到了四種最具代表性的安進藥物。我想請教您和您的團隊一個問題:在審視您目前的產品組合以及外部其他領域時,您認為有哪些領域可以利用安進的能力,而這些領域目前可能尚未得到充分或覆蓋?
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?
我和大衛可以一起解決這個問題。我認為我們已經非常明確地知道我們在外部尋找什麼,那就是符合我們策略興趣領域或我們認為自身優勢的分子。特別是,我們正在尋找發炎、腫瘤和普通醫學領域的機會。我們尋找的是那些可能成為同類首創、同類最佳,並且在我們認為能夠創造價值的患者群體中具有顯著療效的藥物。所以我們一直在尋找。我認為我們並不覺得我們在上述三個特定領域中的任何一個領域特別處於劣勢,或者需要特別強調業務拓展,但我們始終在早期和後期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。我還要補充一點,另一個重要部分是技術平台。鮑伯在開場白中簡單提到了人工智慧和機器學習的應用。我認為我們已經悄悄地成為這一領域的領導者。我們現在正將人工智慧和機器學習應用於研發的各個環節,從分子工程開始。在分子工程領域,我們對乾實驗室或電腦輔助設計在構建新蛋白質分子方面取得的顯著成效感到非常滿意,其所需時間比以往大大縮短,成功率也更高——這裡的成功指的是獲得具有所需分子特性的候選分子。我們也在臨床試驗領域廣泛應用這些技術,例如用於選擇試驗中心以及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,在接下來的時間裡,我會更詳細地談到這一點。但我認為,這類技術平台將引領我們來到這個產業一個至關重要的轉捩點,科技與生物技術的融合將把藥物發現和研發帶入一個截然不同的時代。我相信,我們將擁有非常有利的地位,能夠充分利用這種融合所帶來的機會。
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,我想了解您在輕度乾癬領域,特別是您獲得批准近一年半的領域,是否有任何市場份額或績效指標。我猜您應該對在這個截然不同的細分市場中的滲透率有所了解。
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,提姆,謝謝你的提問。遺憾的是,區分輕度和中度病情比較困難,因為目前還沒有很好的編碼可以用來區分。所以我們關注的是,有多少比例的患者是未接受過全身性治療的患者,我們推斷他們的病情較輕,並且在使用奧特茲拉之前接受的最後一種治療是局部用藥。目前,我們新增患者中有 80% 來自局部治療後、尚未接受全身性治療的患者。所以我們確實取得了進展。
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,我們目前正在加強推廣力度,重點關注這些患者接受治療的場所,我們預計能夠增加我們吸引的患者數量。正如您所看到的,本季 Otezla 的銷量成長了 5%,我們預計能夠在此基礎上進一步提升。
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,我知道現在已經過了半點了。這是我們之前請同事們預留的通話時間。不過我們還有幾個問題想問。我們會盡量先回答這些問題,然後,按照慣例,如果有人今晚晚些時候還有問題,我們會隨時解答。現在我們來看下一個問題。
Operator
Operator
Our next question comes from Geoff Meacham from Bank of America.
下一個問題來自美國銀行的傑夫‧米查姆。
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,在你們過去幾年推出的新產品中,EVENITY 表現尤為突出,每個季度都取得了非常不錯的進展。從長遠來看,它的市場前景如何?此外,隨著產品生命週期接近尾聲,你們如何看待整個骨骼產品線的生命週期管理?
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的提問,也謝謝你對EVENITY表現的關注。骨骼團隊在這款產品上做得非常出色。我認為安進在Prolia產品線建置方面累積的經驗,以及我們與UCB的合作,都對此起到了很大的幫助。我最近剛去過日本。正如Bob在開場白中所提到的,日本是一個超老化社會。 EVENITY在日本的銷售情況非常好,我認為它很好地預示了我們在美國使用這款產品所能取得的成績。所以我認為,我們目前還處於早期階段,尚未完全掌握EVENITY這類骨骼強化藥物的市場潛力,它能夠惠及數百萬患者。
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.
我們也看到,對於這些患者來說,治療方案可以很好地銜接起來。例如,假設您正在服用雙磷酸鹽或普羅利亞(Prolia),但發生了骨折,您可以先使用 EVENITY 治療 12 個月,然後再繼續使用地諾單抗或普羅利亞等產品進行後續治療。因此,普羅利亞和 EVENITY 都蘊藏著巨大的市場潛力。我們認為,目標族群非常龐大,而且我們目前仍處於產品發展的早期階段,儘管其年銷售額已超過 10 億美元。這對我們來說是一個令人振奮的成長機會。我們對此充滿熱情。
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,我們再回答最後一個問題,之後 Bob 將作總結發言。
Operator
Operator
Our next question comes from Dane Leone from Raymond James.
我們的下一個問題來自 Raymond James 公司的 Dane Leone。
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.
在討論今年的最新業績指引時,我還有兩點關於競爭格局的問題想請教大家。首先,Repatha 的發展勢頭強勁。本週早些時候,諾華重點介紹了 Leqvio(或 inclisiran),該藥終於在美國市場取得了一些進展。我很想聽聽您對 PCSK9 抑制劑類藥物在今年剩餘時間內的競爭格局有何看法。其次,與此類似,我注意到 LUMAKRAS 在美國第一季的季比下降。我想知道您是否認為 Mirati 的競爭藥物 Krazati 對其造成了影響。
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.
是的,謝謝。或許我會反過來回答這個問題。現在判斷 Mirati 的影響還為時過早。正如我在之前回答問題時提到的,實際需求量環比基本持平。我們目前看到的銷售情況是,LUMAKRAS 的終端用戶庫存從第四季度到今年第一季有所減少;但實際接受治療的患者數量環比基本持平。因此,我們目前還沒有看到 Mirati 的顯著影響。當然,對於 LUMAKRAS,我們目前正專注於透過拓展適應症和收集更多數據來推動 LUMAKRAS 的發展,以便將其應用於更早期的治療方案,Dave 在他的發言中也提到了這一點。
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.
展望Repatha,我們目前所看到的景象令人振奮。我們看到,心臟科醫生對Repatha的熱情日益高漲,他們不僅在治療ASCVD患者時表現出更廣泛的興趣,而且對Repatha的認可度也越來越高,例如,他們在處方中使用Repatha的頻率越來越高。在過去的18個月裡,我們一直在努力提升Repatha在基層醫療機構的商業影響力。今年,我們將進一步擴大基層醫療銷售團隊的規模,從而在基層醫療推廣方面取得重大進展。
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.
所以,Repatha的發展方向非常正確,病人也從中受益。我們在PCSK9抑制劑類藥物市場佔了70%以上的份額。但坦白說,這並非我們團隊關注的重點。我們致力於幫助數百萬甚至數千萬需要將低密度脂蛋白膽固醇(LDL-C)降至目標值以下的動脈粥狀硬化性心血管疾病(ASCVD)患者。正如我在開場白中提到的,只有不到30%的患者——這並非我們的數據,而是來自家庭心臟組織(Family Heart Organization)的數據——達到了他們的LDL-C目標值。因此,我們認為這項工作意義重大。我們相信Repatha是同類藥物中的佼佼者,擁有廣泛的市場覆蓋,我們期待在未來幾年繼續在全球推廣這款產品,造福數百萬患者。
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。謝謝默多回答這個問題。也請允許我再次感謝各位參加這次電話會議。我只想簡單說幾點。顯然,正如大家從第一季的業績中看到的那樣,我們今年的開局不錯。正如我在開場白中所說,比第一季業績本身更重要的是它如何為我們的長期發展奠定基礎。
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.
所以,回顧我們之前討論過的對我們至關重要的因素,以及我們能否實現長期成長策略,首先要確保我們的成長型產品能夠取得優異的業績。正如您在本季所看到的,我們有10個品牌取得了創紀錄的業績。業績優異意味著市場佔有率和滲透率的成長。正如默多所說,我們現在看到,我們重要的成長驅動型品牌正在實現這一目標。
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.
我們也說過,要取得長期的成功,我們必須在國際市場上有所作為。而且,我認為年初的銷售趨勢很好地表明,我們正在建立必要的平台,以實現我們在美國以外地區藥品市場的長期成長。
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重點討論了生物相似藥。我們說過,隨著新產品上市並拓展到新的市場,我們認為生物相似藥是我們長期成長的重要動力。為了實現這一目標,我們需要成為領先業界的競爭者,這意味著我們需要按時完成任務,並搶佔先機。本季度,AMJEVITA 的上市、BEKEMV 的獲批等一系列舉措,再次證明了我們能夠持續做到這一點。因此,我們認為,從競爭角度來看,我們在生物相似藥領域佔據了有利地位,能夠充分掌握市場機會。
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.
當然,研發管線始終至關重要。我們很高興看到我們的研發管線進展迅速,尤其是在註冊所需的臨床試驗方面,無論是 tarlatamab、bema 還是 rocatinlimab。我們正在進行許多重要的註冊準備工作,並期待這些產品組合以及一些目前備受關注的產品(例如 133 和我們的中期研發管線)能夠取得成果。
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.
總而言之,本季開局良好,我們對長期前景依然充滿信心。同時,我們期待監管機構完成審批後,能有機會完成Horizon的交易。感謝各位的收聽,我們期待八月與大家再次相聚。
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.
太好了。謝謝大家,我們會一直在這裡。所以如果你們有任何問題,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.
本次2023年第一季及全年財務業績電話會議到此結束。您可以斷開連線了。