該公司還在繼續其在心血管疾病和炎症等其他領域的研發工作。
Amgen 是一家大型生物製藥公司,產品種類繁多。公司總部位於加利福尼亞州千橡市,成立於 1980 年。安進專注於腫瘤學、腎病學和血液學等領域。
該公司計劃發布一種新藥LUMAKRAS,用於治療非小細胞肺癌。該藥物旨在與化療聯合使用。該公司還計劃發布 EYLEA 的生物仿製藥,這是一種用於治療新生血管性年齡相關性黃斑變性的藥物。這種生物仿製藥被稱為 ABP 938。
該公司正在繼續進行各種癌症治療的臨床試驗。特別是,他們提到了 LUMAKRAS 檢查點抑製劑和 SHIP2 組合的試驗。這些研究的數據令人鼓舞。
公司未來的計劃包括繼續探索 LUMAKRAS 在一線和二線環境中的潛力。此外,該公司計劃將上市後研究的數據提交給監管機構。
該公司還在繼續其在心血管疾病和炎症等其他領域的研發工作。正文討論了 FDA 決定不向生物仿製藥 AMGEVITA 的標籤添加可互換性。 FDA 認為,這種生物仿製藥還沒有準備好上市,需要更多的測試。文中還討論了Repatha產品在中國的成功和LUMAKRAS產品在歐洲和美國的成功。
Amgen 董事長兼首席執行官 Bob Bradway 討論了公司第三季度的財務業績。他將公司的成功歸功於對其藥品的強勁需求以及它們為患者帶來的價值。他指出,銷售額同比增長 3%,而 ENBREL 銷售額同比下降 14%。新產品 TEZSPIRE 在第三季度創造了 5500 萬美元的銷售額。
在回答有關美國市場生物仿製藥吸收的問題時,首席執行官表示,每種產品都需要略有不同的看法。他們提到了腫瘤學、罕見病和眼部空間作為例子。他們說,在腫瘤學領域,患者可能不會在治療的維持階段改用生物仿製藥,但在罕見病領域,患者的旅程有點不同。他們還表示,在眼界,市場參與者眾多,決策過程不同。他們所有人共有的一件事是,生物仿製藥需要一段時間才能在市場上獲得吸引力。
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 Jason, and I will be your conference facilitator today for Amgen's Third Quarter 2022 Financial Results Conference Call. (Operator Instructions)
我叫傑森,今天我將擔任安進公司 2022 年第三季度財務業績電話會議的會議主持人。 (操作員說明)
I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.
我現在想介紹投資者關係副總裁 Arvind Sood。蘇德先生,您現在可以開始了。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Okay. Thank you, Jason. Good afternoon, everybody, and welcome to our Q3 call. So we continued with our execution during the quarter with a focus on driving volume growth for our key products and advancing our innovative pipeline.
好的。謝謝你,傑森。大家下午好,歡迎來到我們的第三季度電話會議。因此,我們在本季度繼續執行,重點是推動我們關鍵產品的銷量增長並推進我們的創新管道。
Leading the discussion today will be our Chairman and CEO, Bob Bradway. We have posted some slides for your reference and my customary reminder that we'll be making some forward-looking statements and use non-GAAP financial measures to describe our performance.
領導今天討論的將是我們的董事長兼首席執行官 Bob Bradway。我們已經發布了一些幻燈片供您參考,並按照我的慣例提醒我們,我們將做出一些前瞻性陳述並使用非公認會計原則財務指標來描述我們的業績。
So with that, I would like to turn the call over to Bob.
因此,我想將電話轉給 Bob。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Okay. Thank you, all of you, for joining our call. In the face of both macroeconomic and industry-specific challenges, Amgen remains laser-focused on delivering for patients and shareholders. Benefit of that focus was evident in the third quarter with volumes up a healthy 8% and 16% outside the United States. These results reflect the strong underlying demand for our medicines and the value they bring to patients even in challenging economic times like those prevailing at the moment.
好的。謝謝大家加入我們的電話。面對宏觀經濟和特定行業的挑戰,安進仍然專注於為患者和股東提供服務。這種關注的好處在第三季度很明顯,美國以外的銷量增長了 8% 和 16%。這些結果反映了對我們藥物的強勁潛在需求以及它們為患者帶來的價值,即使在像目前這樣充滿挑戰的經濟時代也是如此。
Revenues for the quarter were down 1%, reflecting a 5% net price decline consistent with what we communicated earlier in the year and a 2% impact from foreign exchange. All told, 11 of our products generated record sales in the quarter, and non-GAAP earnings per share increased 15% with free cash flows reaching $2.8 billion for the quarter. Looking forward, we remain focused on several growth drivers.
本季度的收入下降了 1%,反映出淨價格下降 5%,與我們今年早些時候傳達的一致,以及 2% 的外匯影響。總而言之,我們的 11 種產品在本季度創造了創紀錄的銷售額,非 GAAP 每股收益增長了 15%,本季度自由現金流達到 28 億美元。展望未來,我們仍然專注於幾個增長動力。
With the recent closing of the ChemoCentryx acquisition, we're excited to have TAVNEOS in our portfolio. TAVNEOS is the first new treatment for ANCA-associated vasculitis in more than 10 years, and we're confident that we can leverage our decades of experience in inflammation and nephrology to bring this innovative medicine to many more patients moving forward.
隨著最近完成對 ChemoCentryx 的收購,我們很高興將 TAVNEOS 納入我們的投資組合。 TAVNEOS 是 10 多年來針對 ANCA 相關性血管炎的第一個新療法,我們有信心利用我們在炎症和腎髒病學領域數十年的經驗,將這種創新藥物帶給更多的患者。
Two recently launched products, TEZSPIRE and LUMAKRAS, are off to solid starts. TEZSPIRE is performing well in asthma, and we have studies underway for several other indications for that product as well. LUMAKRAS is performing well globally with patients, payers and prescribers recognizing the importance of this innovation. With combination studies underway, we're exploring the many different ways this product may benefit patients through time.
最近推出的兩款產品 TEZSPIRE 和 LUMAKRAS 已經開始穩健發展。 TEZSPIRE 在哮喘方面表現良好,我們也在對該產品的其他幾個適應症進行研究。 LUMAKRAS 在全球範圍內表現良好,患者、付款人和處方者認識到這項創新的重要性。隨著聯合研究的進行,我們正在探索該產品可能會隨著時間的推移而使患者受益的許多不同方式。
We have a number of key products led by Repatha, Otezla, Prolia and EVENITY that we know can benefit millions more patients globally than they do today. And let's not lose sight of the fact that these 4 products collectively generated $2 billion in third quarter sales with volume growth of 17%.
我們擁有由 Repatha、Otezla、Prolia 和 EVENITY 領導的許多關鍵產品,我們知道這些產品可以使全球數百萬患者受益,比現在多。我們不要忽視這樣一個事實,這 4 種產品在第三季度共創造了 20 億美元的銷售額,銷量增長了 17%。
We've built an industry-leading biosimilars business, having now launched 5 products in markets around the world, and we're months away from being the first company to launch a biosimilar to HUMIRA in the U.S. AMGEVITA is already the most prescribed HUMIRA biosimilar in Europe, giving us confidence as we prepare to enter the U.S. market.
我們已經建立了行業領先的生物仿製藥業務,現已在全球市場推出 5 種產品,距離成為第一家在美國推出 HUMIRA 生物仿製藥的公司還有幾個月的時間。AMGEVITA 已經是處方最多的 HUMIRA 生物仿製藥在歐洲,讓我們在準備進入美國市場時充滿信心。
Looking forward, our next wave of biosimilars to STELARA, SOLIRIS and EYLEA are well positioned with our having now successfully completed Phase III trials for all 3 of these molecules. We have many potential new medicines advancing through our innovative pipeline, including Olpasiran, tarlatamab, rocatinlimab, bemarituzumab and AMG 133. These 5 molecules and several others that you'll hear about shortly from Dave Reese are vintage Amgen, which is first-in-class medicines that make a big difference for patients suffering from serious diseases for which there remains a real need for new and better treatments.
展望未來,我們對 STELARA、SOLIRIS 和 EYLEA 的下一波生物仿製藥處於有利地位,我們現已成功完成所有這三種分子的 III 期試驗。我們有許多潛在的新藥正在通過我們的創新管道推進,包括 Olpasiran、tarlatamab、rocatinlimab、bemarituzumab 和 AMG 133。這 5 種分子以及您將很快從 Dave Reese 那裡聽到的其他幾種分子是老式 Amgen,它是首創類藥物對患有嚴重疾病的患者產生重大影響,對於這些疾病仍然需要新的更好的治療方法。
Finally, we have a highly engaged and committed workforce, and I want to thank them, as always, for their great work. With that, let me turn over to our CFO, Peter Griffith.
最後,我們擁有一支高度敬業、敬業的員工隊伍,我要一如既往地感謝他們所做的出色工作。有了這個,讓我轉給我們的首席財務官彼得格里菲斯。
Peter H. Griffith - Executive VP & CFO
Peter H. Griffith - Executive VP & CFO
Thank you, Bob. We're pleased with our execution this quarter, and we are on track to deliver against our long-term objectives, most importantly serving patients. Our recently closed acquisition of ChemoCentryx adds a newly launched innovative product to our portfolio, TAVNEOS, a first-in-class and best-in-class approved treatment for patients with ANCA-associated vasculitis.
謝謝你,鮑勃。我們對本季度的執行感到滿意,我們有望實現我們的長期目標,最重要的是為患者服務。我們最近完成的對 ChemoCentryx 的收購為我們的產品組合增加了一個新推出的創新產品 TAVNEOS,這是一種用於 ANCA 相關血管炎患者的一流和一流的批准治療。
Let's walk through our third quarter financial results before discussing our 2022 guidance. The financial results are shown on Slide 6 of the slide deck. In Q3, we recognized total revenue of $6.7 billion. This represents a modest decline of 1% year-over-year. Excluding the impact of foreign currency, total revenue and product sales grew 2% and 1%, respectively.
在討論我們的 2022 年指導之前,讓我們先了解一下我們的第三季度財務業績。財務結果顯示在幻燈片的幻燈片 6 上。在第三季度,我們確認了 67 億美元的總收入。這意味著同比小幅下降 1%。剔除外匯影響,總收入和產品銷售額分別增長 2% 和 1%。
Earnings per share of $4.70 grew 15% versus our recast Q3 2021. Recall those results included $400 million recorded in R&D expense related to our upfront payment to license rights to AMG 451, rocatinlimab, from Kyowa Kirin Corporation, KKC. Non-GAAP EPS grew 1%, excluding the $400 million expense for the KKC license.
與我們重鑄的 2021 年第三季度相比,每股收益 4.70 美元增長了 15%。回想一下,這些結果包括與我們從 Kyowa Kirin Corporation, KKC 獲得 AMG 451 rocatinlimab 許可權的預付款相關的研發費用中記錄的 4 億美元。非 GAAP 每股收益增長 1%,不包括 KKC 許可的 4 億美元費用。
Murdo will review product sales with you, but I would highlight that our established product portfolio generated almost $900 million in product sales and continues to deliver strong cash flows to fund both internal and external innovation. Other revenues of $415 million increased 8% year-over-year.
Murdo 將與您一起審查產品銷售情況,但我要強調的是,我們已建立的產品組合產生了近 9 億美元的產品銷售收入,並繼續提供強勁的現金流來為內部和外部創新提供資金。其他收入為 4.15 億美元,同比增長 8%。
Non-GAAP operating expenses decreased 8% year-over-year primarily driven by the $400 million payment to KKC in Q3 2021. Excluding the impact of the $400 million upfront payment, third quarter total non-GAAP operating expenses increased 4% year-over-year, reflecting investments to advance our research capabilities and pipeline while also supporting product launches. And we delivered a 52.5% operating margin as a percentage of product sales.
非 GAAP 運營費用同比下降 8%,主要是由於 2021 年第三季度向 KKC 支付了 4 億美元。不計 4 億美元預付款的影響,第三季度非 GAAP 運營費用總額同比增長 4% -年,反映了為提高我們的研究能力和管道而進行的投資,同時也支持產品發布。我們的營業利潤率佔產品銷售額的百分比為 52.5%。
On a non-GAAP basis, cost of sales as a percent of product sales increased 0.3 percentage points on a year-over-year basis to 16.1% primarily due to changes in product mix, partially offset by lower manufacturing costs and lower costs associated with fewer COVID-19 antibody shipments. Excluding the $400 million upfront payment, non-GAAP R&D spend in the third quarter increased 10% year-over-year primarily due to higher late-stage program support and research and early pipeline spend, partially offset by lower marketed product support.
在非公認會計原則的基礎上,銷售成本佔產品銷售額的百分比同比增長 0.3 個百分點至 16.1%,主要是由於產品組合的變化,部分被較低的製造成本和較低的成本所抵消減少 COVID-19 抗體出貨量。剔除 4 億美元的預付款,第三季度非 GAAP 研發支出同比增長 10%,主要是由於後期項目支持和研究以及早期管道支出增加,部分被較低的市場產品支持所抵消。
Non-GAAP SG&A expenses increased 1% year-over-year. We continue to focus on prioritizing key investments and activities while driving productivity, automation and digitalization. Non-GAAP OI&E was about $370 million in expense in the third quarter. This was driven by increased net interest expense and our share of BeiGene results because of our use of the equity method of accounting. Our OI&E was lower than anticipated due to gains from liability management that we do not expect to the same extent in future quarters.
非 GAAP SG&A 費用同比增長 1%。我們繼續專注於優先考慮關鍵投資和活動,同時推動生產力、自動化和數字化。第三季度非 GAAP OI&E 的費用約為 3.7 億美元。這是由於我們使用權益會計法增加了淨利息費用和我們在百濟神州業績中的份額。我們的 OI&E 低於預期,因為我們預計未來幾個季度的負債管理收益不會相同。
We have a strong balance sheet, generates significant cash flow and retain significant financial flexibility to execute strategic business development opportunities and execute on our multiple capital allocation priorities. In the third quarter, we executed on the following: first, our recent acquisition at ChemoCentryx is a clear example of investing in the best innovation, in this case, external for patients; second, investing in our business through capital expenditures, including advancing construction on our new environmentally friendly facilities in Ohio and North Carolina; third, returning capital to shareholders through growing dividends, including $1.94 per share in the quarter, representing a 10% increase from Q3 2021; and fourth, opportunistic share repurchases. The final settlement of the accelerated share repurchase, ASR program, occurred in the third quarter, and we have repurchased about $6.3 billion of shares year-to-date.
我們擁有強大的資產負債表,產生可觀的現金流並保持顯著的財務靈活性,以執行戰略業務發展機會並執行我們的多個資本分配優先事項。在第三季度,我們執行了以下操作:首先,我們最近在 ChemoCentryx 的收購是投資最佳創新的一個明顯例子,在這種情況下,是針對患者外部的;其次,通過資本支出投資我們的業務,包括推進我們在俄亥俄州和北卡羅來納州的新環保設施的建設;第三,通過增加股息向股東返還資本,包括本季度每股 1.94 美元,較 2021 年第三季度增長 10%;第四,機會性股票回購。加速股票回購 ASR 計劃的最終結算發生在第三季度,我們今年迄今已回購了約 63 億美元的股票。
Turning to the outlook for the business for 2022. We're pleased with our execution through the third quarter. For the full year, we now expect to absorb about $560 million in FX headwinds against product sales based on recent FX rates, of which we absorbed nearly $400 million through the third quarter and this is net of our hedging activities.
談到 2022 年的業務前景。我們對第三季度的執行情況感到滿意。根據最近的外匯匯率,我們現在預計全年將吸收約 5.6 億美元的外匯逆風來應對產品銷售,其中我們在第三季度吸收了近 4 億美元,這是我們對沖活動的淨值。
Reflecting our strong execution through the third quarter and despite challenging foreign exchange dynamics, we're updating our 2022 revenue guidance range to $26.0 billion to $26.3 billion. We are updating our non-GAAP EPS range to $17.25 to $17.85. This range encompasses both FX headwinds of approximately 3% or $0.45 for the full year based on recent FX rates and costs associated with our acquisition of ChemoCentryx incurred between closing and year-end.
反映我們在第三季度的強勁執行力,儘管外匯動態充滿挑戰,我們將 2022 年的收入指導範圍更新為 260 億美元至 263 億美元。我們將我們的非公認會計原則每股收益範圍更新為 17.25 美元至 17.85 美元。根據最近的外匯匯率和與我們收購 ChemoCentryx 相關的成本,這一範圍包括全年約 3% 或 0.45 美元的外匯逆風。
I'll share a few additional points to consider for the remainder of 2022 with a particular focus on how these trends are likely to impact Q4. We expect FX headwinds to reduce product sales in Q4 by about $165 million. The U.S. government has agreed to purchase $290 million of Nplate. We will recognize about $200 million of those sales in Q4 with the remainder in 2023.
我將分享一些在 2022 年剩餘時間內需要考慮的其他要點,特別關注這些趨勢可能如何影響第四季度。我們預計外匯逆風將使第四季度的產品銷售額減少約 1.65 億美元。美國政府已同意購買 2.9 億美元的 Nplate。我們將在第四季度確認其中約 2 億美元的銷售額,其餘的將在 2023 年確認。
We have completed the previously discussed divestiture of Gensenta, our generics business, in Turkey and will no longer recognize product sales and operating expenses from that business effective November 2, 2022. Sales of that business annualized at approximately $90 million. We now expect full year other revenue for 2022 between $1.5 billion to $1.6 billion versus our prior guidance of $1.4 billion to $1.6 billion.
我們已經完成了之前討論的對我們在土耳其的仿製藥業務 Gensenta 的剝離,並且自 2022 年 11 月 2 日起將不再確認該業務的產品銷售和運營費用。該業務的年銷售額約為 9000 萬美元。我們現在預計 2022 年全年其他收入在 15 億美元至 16 億美元之間,而我們之前的指導為 14 億美元至 16 億美元。
When comparing against our recast 2021 results, we continue to expect full year non-GAAP operating expenses to reflect a low double-digit decrease year-over-year. We continue to expect 2022 non-GAAP operating margin as a percentage of product sales to be roughly 50%. We continue to expect non-GAAP cost of sales in the range of 15.5% to 16.5% as a percentage of product sales.
與我們重鑄的 2021 年結果進行比較時,我們繼續預計全年非公認會計準則運營費用將反映同比低兩位數的下降。我們繼續預計 2022 年非 GAAP 營業利潤率佔產品銷售額的百分比約為 50%。我們繼續預計非 GAAP 銷售成本佔產品銷售額的百分比在 15.5% 至 16.5% 之間。
We now expect non-GAAP R&D expenses in 2022 to decrease 5% to 8% year-over-year compared to our recast 2021 non-GAAP R&D expenses, which include the $400 million upfront payment we discussed above. We expect non-GAAP SG&A spend to be roughly flat year-over-year as a percentage of product sales.
我們現在預計 2022 年非 GAAP 研發費用將比我們重鑄的 2021 年非 GAAP 研發費用(包括我們上面討論的 4 億美元預付款)同比下降 5% 至 8%。我們預計非 GAAP SG&A 支出佔產品銷售額的百分比將與去年同期大致持平。
We expect OI&E to be in the range of $1.6 billion to $1.7 billion with fourth quarter results closer to the first and second quarter results. For the full year, we now anticipate a non-GAAP tax rate range of 13.5% to 14.5%, down from our prior guidance of 14.0% to 15.0%.
我們預計 OI&E 將在 16 億美元至 17 億美元之間,第四季度的結果更接近第一和第二季度的結果。對於全年,我們現在預計非 GAAP 稅率範圍為 13.5% 至 14.5%,低於我們之前的 14.0% 至 15.0% 的指導。
As you consider your modeling for 2023, recall that tax law changes enacted by Puerto Rico in June of 2022 that replaced the Puerto Rico excise tax, the PRET, in favor of an income tax will increase our 2023 income tax expense while reducing by roughly an equivalent amount of cost of goods sold. Note, however, there will be a onetime residual negative impact in 2023 related to the amount of the PRET currently capitalized in inventory that will be charged to cost of goods sold without a corresponding tax benefit. This charge is slightly larger than the benefit previously recognized with the implementation of the PRET in 2011, which was discussed in our 2011 Form 10-K.
當您考慮 2023 年的模型時,請回想一下,波多黎各於 2022 年 6 月頒布的稅法變更取代了波多黎各消費稅 PRET 以支持所得稅,這將增加我們 2023 年的所得稅費用,同時減少大約等量的已售商品成本。但請注意,2023 年將產生一次性的殘餘負面影響,該影響與目前在庫存中資本化的 PRET 金額相關,該金額將計入未獲得相應稅收優惠的已售商品成本。這筆費用略高於之前在 2011 年實施 PRET 時確認的收益,我們在 2011 年的 10-K 表格中對此進行了討論。
Summing up, since the business review in February, much has changed at the macro level with the strengthening of the U.S. dollar, persistently high inflation, higher interest rates and the passing of the Inflation Reduction Act. Despite these headwinds, we have executed well in 2022. As we plan for 2023, we anticipate that these headwinds will continue. We're adapting our operating plans and expect to successfully execute against them.
綜上所述,自 2 月份的業務檢討以來,隨著美元走強、通脹居高不下、利率上升以及《減通脹法案》的通過,宏觀層面發生了很大變化。儘管存在這些不利因素,但我們在 2022 年的執行情況良好。在我們計劃 2023 年時,我們預計這些不利因素將繼續存在。我們正在調整我們的運營計劃,並希望成功地執行這些計劃。
Like previous years, we expect to provide 2023 guidance on our Q4 earnings call in January. Our confidence in the long-term growth of Amgen remains strong. I thank our millions of patients for their courage and my 25,000 colleagues for their mission-driven work on behalf of those patients every day.
與往年一樣,我們預計將在 1 月份的第四季度財報電話會議上提供 2023 年的指引。我們對安進的長期增長充滿信心。我感謝我們數百萬患者的勇氣,感謝我的 25,000 名同事每天代表這些患者開展以使命為導向的工作。
This concludes the financial update. I'll turn it over to Murdo.
財務更新到此結束。我會把它交給默多。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Thanks, Peter. We saw strong volume growth in the third quarter with an 8% increase year-on-year. We delivered record quarterly sales for 11 products, including EVENITY, TEZSPIRE, AMGEVITA, Vectibix, KYPROLIS, Nplate and BLINCYTO; and double-digit volume growth for several additional products, including Repatha and LUMAKRAS. Excluding the impact of foreign exchange, third quarter global product sales grew 1% as our volume increases were offset by a 5% decline in net selling price, consistent with our prior estimates. Including the 2% negative foreign exchange impact, product sales declined 1% year-over-year.
謝謝,彼得。我們在第三季度看到強勁的銷量增長,同比增長 8%。 EVENITY、TEZSPIRE、AMGEVITA、Vectibix、KYPROLIS、Nplate 和 BLINCYTO 等 11 種產品實現了創紀錄的季度銷售額;包括 Repatha 和 LUMAKRAS 在內的幾種其他產品的銷量實現了兩位數的增長。排除外匯影響,第三季度全球產品銷售額增長 1%,因為我們的銷量增長被淨售價下降 5% 所抵消,這與我們之前的估計一致。包括 2% 的負面外匯影響,產品銷售額同比下降 1%。
I'll start now with our general medicine business, which includes Prolia, EVENITY, Repatha and Aimovig. Overall revenue for this portfolio grew 14% year-over-year driven by 20% volume growth. In bone health, Prolia sales grew 7% year-over-year driven by 8% volume growth. EVENITY, which complements Prolia in our bone portfolio, had record sales of $201 million for the quarter driven by 45% volume growth in the U.S. and 30% volume growth outside of the U.S.
我現在將從我們的普通醫藥業務開始,其中包括 Prolia、EVENITY、Repatha 和 Aimovig。在銷量增長 20% 的推動下,該投資組合的總收入同比增長 14%。在骨骼健康方面,Prolia 的銷售額在 8% 的銷量增長的推動下同比增長了 7%。 EVENITY 在我們的骨骼產品組合中補充了 Prolia,在美國銷量增長 45% 和美國以外銷量增長 30% 的推動下,本季度銷售額達到創紀錄的 2.01 億美元。
Repatha sales increased 14% year-over-year driven by 52% volume growth, which was partially offset by lower net selling price. In the U.S., we generated 32% volume growth aided by broad adoption of Repatha by cardiologists and increasing adoption by primary care providers. We also saw declining net selling prices in the U.S. as we offered higher rebates to support broad Medicare Part D and commercial patient access.
在銷量增長 52% 的推動下,Repatha 的銷售額同比增長 14%,這部分被較低的淨售價所抵消。在美國,由於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,我們實現了 32% 的銷量增長。我們還看到美國的淨售價下降,因為我們提供更高的回扣以支持廣泛的醫療保險 D 部分和商業患者的准入。
Looking ahead to 2023, we expect less year-over-year U.S. price erosion than we saw in 2022. Outside the U.S., sales of Repatha grew 26% driven by 73% volume growth. Net price declines outside the U.S. were primarily a result of Repatha's inclusion on China's National Reimbursement Drug List as of January 1, 2022. Overall, we remain focused on addressing leading cause of morbidity and mortality by bringing Repatha to patients in need all around the world.
展望 2023 年,我們預計美國價格同比下降的幅度將低於 2022 年。在美國以外,Repatha 的銷售額增長了 26%,這得益於 73% 的銷量增長。美國以外地區的淨價格下跌主要是由於瑞百安於 2022 年 1 月 1 日被納入中國國家報銷藥品目錄。總體而言,我們仍然專注於通過將瑞百安帶給全球有需要的患者來解決發病率和死亡率的主要原因.
Moving to our inflammation portfolio. Otezla sales increased 3% year-over-year for the quarter. Otezla saw 9% volume growth, partially offset by lower inventory and unfavorable foreign exchange impact. In the U.S., Otezla remains the leader in bio-naive psoriasis patient share, and we see broader adoption of Otezla among patients with mild-to-moderate psoriasis. Looking forward, we expect continued strong volume growth given Otezla's established safety profile, strong payer coverage and unique position as the only systemic oral that can treat a broad spectrum of patients with psoriasis regardless of the severity of their disease.
轉到我們的炎症產品組合。 Otezla 本季度銷售額同比增長 3%。 Otezla 的銷量增長了 9%,部分被庫存減少和不利的外匯影響所抵消。在美國,Otezla 仍然是生物銀屑病患者份額的領導者,我們看到 Otezla 在輕度至中度銀屑病患者中得到更廣泛的採用。展望未來,鑑於 Otezla 已確立的安全性、強大的付款人覆蓋範圍以及作為唯一可以治療廣泛銀屑病患者的全身性口服藥物的獨特地位,我們預計銷量將繼續強勁增長,無論其疾病的嚴重程度如何。
ENBREL sales decreased 14% year-over-year for the third quarter driven by lower net selling price, unfavorable changes to estimated sales deductions and a 3% decline in volume. ENBREL remains an important product for patients due to its long track record of efficacy and safety.
由於淨售價下降、估計銷售扣除額的不利變化以及銷量下降 3%,第三季度 ENBREL 銷售額同比下降 14%。由於其長期的療效和安全性記錄,ENBREL 仍然是患者的重要產品。
I'm very pleased with our strong U.S. launch of TEZSPIRE, which generated $55 million of sales in the third quarter. Allergists and pulmonologists have prescribed TEZSPIRE across a broad range of patients with severe uncontrolled asthma. We're also seeing initiation in both biologic-naive and previously treated patients. Physicians acknowledge TEZSPIRE's unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe asthma who are uncontrolled without requiring any phenotypic and biomarker testing.
我對我們在美國強勁推出的 TEZSPIRE 感到非常高興,它在第三季度創造了 5500 萬美元的銷售額。過敏症專家和肺科醫生已經為廣泛的嚴重哮喘患者開出了 TEZSPIRE。我們還看到在未接受過生物治療的患者和先前接受過治療的患者中開始使用。醫生承認 TEZSPIRE 獨特的差異化特徵及其廣泛的潛力,可治療全球 250 萬不受控制的嚴重哮喘患者,無需任何表型和生物標誌物測試。
We recently completed our acquisition of ChemoCentryx, which adds TAVNEOS to our portfolio. TAVNEOS recently launched as a first-in-class treatment for ANCA-associated vasculitis, or AAV. This is a serious systemic autoimmune disease that leads to inflammation and eventual destruction of small blood vessels. This inflammatory disease can lead to permanent organ damage and, in some severe cases, can be life-threatening. TAVNEOS represents a significant advance in treatment for the 8,000 to 10,000 U.S. patients a year who develop severe active disease or experience major relapses of AAV.
我們最近完成了對 ChemoCentryx 的收購,將 TAVNEOS 添加到我們的產品組合中。 TAVNEOS 最近作為 ANCA 相關血管炎或 AAV 的一流治療藥物推出。這是一種嚴重的全身性自身免疫性疾病,會導致炎症並最終破壞小血管。這種炎症性疾病會導致永久性器官損傷,在某些嚴重的情況下,可能會危及生命。 TAVNEOS 代表了每年 8,000 至 10,000 名發生嚴重活動性疾病或經歷 AAV 嚴重複發的美國患者在治療方面的重大進步。
AAV is often managed by rheumatologists and nephrologists, where Amgen has a strong market presence and successful track record. We look forward to applying our deep expertise and inflammation experience to help many more patients manage AAV with TAVNEOS.
AAV 通常由風濕病學家和腎病學家管理,安進在這方面擁有強大的市場佔有率和成功的記錄。我們期待運用我們深厚的專業知識和炎症經驗來幫助更多患者使用 TAVNEOS 管理 AAV。
Moving to our hematology and oncology business. Our 6 innovative products grew 8% year-over-year with 10% volume growth. For Vectibix and Nplate, strong volume growth in the quarter benefited from timing of shipments to our partners in Japan.
轉向我們的血液學和腫瘤學業務。我們的 6 款創新產品同比增長 8%,銷量增長 10%。對於 Vectibix 和 Nplate,本季度強勁的銷量增長得益於向我們在日本的合作夥伴發貨的時機。
Our launch of LUMAKRAS is progressing well with revenues of $75 million in the third quarter. Quarter-over-quarter sales declined 3% driven by lower net selling price due to a $12 million unfavorable price adjustment resulting from our reimbursement approval in Germany. This was partially offset by 15% volume growth.
我們推出的 LUMAKRAS 進展順利,第三季度收入為 7500 萬美元。由於我們在德國的報銷批准導致 1200 萬美元的不利價格調整,導致淨售價下降,導致銷售額環比下降 3%。這被 15% 的銷量增長部分抵消。
In the U.S., LUMAKRAS has been prescribed to over 3,700 patients by over 2,200 clinicians in both academic and community settings. Outside the U.S., LUMAKRAS has now been approved in over 45 countries. We've launched in 30 markets and are rapidly pursuing reimbursement in the remaining markets.
在美國,超過 2,200 名臨床醫生在學術和社區環境中為 3,700 多名患者開出了 LUMAKRAS 處方。在美國以外,LUMAKRAS 現已在超過 45 個國家獲得批准。我們已在 30 個市場推出,並正在迅速在其餘市場尋求報銷。
As we've noted before, near term, the market for LUMAKRAS is focused on the 7,000 U.S. and 20,000 ex U.S. patients in the second-line setting. Longer term, we expect LUMAKRAS growth to come from earlier-line therapy and the potential of LUMAKRAS to treat other tumor types.
正如我們之前所指出的,近期,LUMAKRAS 的市場主要集中在二線環境中的 7,000 名美國和 20,000 名美國患者身上。從長遠來看,我們預計 LUMAKRAS 的增長將來自早期治療以及 LUMAKRAS 治療其他腫瘤類型的潛力。
Sales of our oncology biosimilars declined 25% year-over-year. While our biosimilars for MVASI and KANJINTI both hold leading shares, we expect continued net selling price deterioration and accelerating volume declines driven by increased competition. The most recently published average selling price for MVASI in the U.S. declined 37% year-over-year and for KANJINTI, declined 38% year-over-year. Over time, we expect long-term growth in our biosimilars business to be driven by the addition of new molecules and additional launches.
我們的腫瘤生物仿製藥銷售額同比下降 25%。雖然我們用於 MVASI 和 KANJINTI 的生物仿製藥均持有領先份額,但我們預計,由於競爭加劇,淨售價將持續惡化,銷量加速下降。最近公佈的 MVASI 在美國的平均售價同比下降了 37%,而 KANJINTI 的平均售價同比下降了 38%。隨著時間的推移,我們預計生物仿製藥業務的長期增長將受到新分子的添加和額外推出的推動。
We're preparing ourselves for the upcoming launch of AMGEVITA, our HUMIRA biosimilar, in the U.S. in early 2023, followed by the next wave of biosimilar launches to STELARA, EYLEA and SOLIRIS. Overall, I'm very pleased with our execution in the quarter. Our international presence and diverse portfolio of products position us well to deliver on the execution of our long-term growth strategy.
我們正在為即將於 2023 年初在美國推出的 HUMIRA 生物仿製藥 AMGEVITA 做準備,隨後將向 STELARA 、 EYLEA 和 SOLIRIS 推出下一波生物仿製藥。總的來說,我對本季度的執行感到非常滿意。我們的國際影響力和多樣化的產品組合使我們能夠很好地執行我們的長期增長戰略。
And with that, I'll turn it over 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. I'd like to start by welcoming our new colleagues from ChemoCentryx. We're excited that you're now part of Amgen. For research and development, the third quarter was one of continued execution where we presented new data on several programs and continued to progress our innovative clinical pipeline.
謝謝,默多,大家下午好。我想首先歡迎來自 ChemoCentryx 的新同事。我們很高興您現在是安進的一員。對於研發,第三季度是持續執行的一個季度,我們提供了幾個項目的新數據,並繼續推進我們的創新臨床管道。
Beginning with general medicine. This coming weekend at the American Heart Association meeting, we plan to present data from a Phase II study of Olpasiran, a lipoprotein (a) targeting small interfering RNA molecule in subjects with elevated Lp(a). We also plan to present additional data from the Repatha FOURIER and Repatha open-label extension studies highlighting the association between the significant and sustained achievement of low and very low LDL cholesterol levels and lower rates of major cardiovascular events.
從普通醫學開始。在即將到來的這個週末美國心臟協會會議上,我們計劃展示 Olpasiran 的 II 期研究數據,Olpasiran 是一種針對 Lp(a) 升高的受試者的小干擾 RNA 分子的脂蛋白 (a)。我們還計劃提供來自 Repatha FOURIER 和 Repatha 開放標籤擴展研究的更多數據,強調顯著和持續實現低和極低 LDL 膽固醇水平與降低主要心血管事件發生率之間的關聯。
Data from the single- and multiple-dose cohorts of the Phase I study of AMG 133, a multispecific that inhibits the gastric inhibitory polypeptide receptor, or GIPR, and activates the GLP-1 receptor, will be presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease Hybrid Conference in December. As a reminder, the unique aspect of AMG 133 is the inhibition of GIPR, an innovative approach that we chose to take based on human genetic data that suggest decreased expression of GIPR leads to lower body mass index and lower weight. We look forward to discussing the Repatha and Olpasiran data along with an update on AMG 133 at our investor call scheduled for Monday, November 7.
來自 AMG 133 的 I 期研究的單劑量和多劑量隊列的數據將在第 20 屆世界胰島素大會上公佈,AMG 133 是一種抑制胃抑制多肽受體或 GIPR 並激活 GLP-1 受體的多特異性藥物12 月的耐藥性、糖尿病和心血管疾病混合會議。提醒一下,AMG 133 的獨特之處在於對 GIPR 的抑制,這是我們根據人類遺傳數據選擇採用的一種創新方法,表明 GIPR 表達減少會導致體重指數降低和體重減輕。我們期待在定於 11 月 7 日星期一舉行的投資者電話會議上討論 Repatha 和 Olpasiran 的數據以及 AMG 133 的更新。
Turning to inflammation. In September, we presented data from the Phase III SPROUT trial, where Otezla treatment resulted in significant improvement in measures of moderate-to-severe plaque psoriasis at week 16 compared to placebo in children ages 6 to 17. We also presented data from the Otezla Phase III DISCRETE trial, where 16-week data demonstrated statistically significant improvements in genital psoriasis, including skin, itch and quality of life in patients with moderate-to-severe disease. Based on these results, discussion of the FDA is ongoing for DISCRETE to add clinical data to the U.S. prescribing information, and discussions with regulatory authorities globally for SPROUT are forthcoming.
轉向炎症。 9 月,我們提供了 III 期 SPROUT 試驗的數據,在 6 至 17 歲的兒童中,與安慰劑相比,Otezla 治療在第 16 周顯著改善了中度至重度斑塊狀銀屑病的測量值。我們還提供了來自 Otezla 的數據III 期 DISCRETE 試驗,其中 16 週的數據顯示生殖器銀屑病有統計學意義的改善,包括中度至重度疾病患者的皮膚、瘙癢和生活質量。基於這些結果,FDA 正在討論 DISCRETE 以將臨床數據添加到美國的處方信息中,並且即將與全球監管機構討論 SPROUT。
In September, TEZSPIRE was approved in the European Union and in Japan, and regulatory reviews continue in other jurisdictions. In oncology, we presented data from tarlatamab, a DLL3-targeting BiTE molecule being studying in patients with small cell lung cancer. These data demonstrated encouraging antitumor activity with notable response durability and survival. In this setting, tarlatamab delivered a confirmed overall response rate of 23%, a median duration of response of 13 months and a median overall survival of 13.2 months. We continue to enroll patients in a potentially registrational Phase II study in this setting.
9 月,TEZSPIRE 在歐盟和日本獲得批准,其他司法管轄區的監管審查仍在繼續。在腫瘤學方面,我們提供了 tarlatamab 的數據,這是一種針對 DLL3 的 BiTE 分子,正在小細胞肺癌患者中進行研究。這些數據顯示了令人鼓舞的抗腫瘤活性,具有顯著的反應持久性和存活率。在這種情況下,tarlatamab 的總反應率為 23%,中位反應持續時間為 13 個月,中位總生存期為 13.2 個月。在這種情況下,我們繼續招募患者參加一項潛在的註冊 II 期研究。
We're also investigating tarlatamab in combination with standard of care in first-line small cell lung cancer in combination with AMG 404, a PD-1 inhibitor, in patients with second-line or later small cell lung cancer and in neuroendocrine prostate cancer.
我們還在研究 tarlatamab 與一線小細胞肺癌護理標準聯合 AMG 404(一種 PD-1 抑製劑)在二線或晚期小細胞肺癌和神經內分泌前列腺癌患者中的療效。
In August, we presented data from our LUMAKRAS checkpoint inhibitor and SHIP2 combination studies. Based on these data, we continue to explore LUMAKRAS in both settings. In September, we presented data on LUMAKRAS in combination with Vectibix, where this combination demonstrated encouraging efficacy and safety in patients with chemorefractory metastatic colorectal cancer. Phase III trial continues to enroll using this combination.
8 月,我們展示了 LUMAKRAS 檢查點抑製劑和 SHIP2 聯合研究的數據。基於這些數據,我們繼續探索兩種環境中的 LUMAKRAS。 9 月,我們展示了 LUMAKRAS 與 Vectibix 聯合用藥的數據,該組合在化療難治性轉移性結直腸癌患者中顯示出令人鼓舞的療效和安全性。 III 期試驗繼續使用這種組合進行註冊。
We also presented data from the global Phase III CodeBreaK 200 confirmatory trial, where LUMAKRAS treatment led to increased progression-free survival and a significantly higher objective response rate in patients with KRAS G12C mutated non-small cell lung cancer compared with docetaxel. Patient-reported outcomes were also improved with LUMAKRAS versus docetaxel.
我們還提供了來自全球 III 期 CodeBreaK 200 確認試驗的數據,與多西他賽相比,LUMAKRAS 治療可提高 KRAS G12C 突變的非小細胞肺癌患者的無進展生存期和顯著更高的客觀緩解率。與多西他賽相比,LUMAKRAS 也改善了患者報告的結果。
We've just received initial top line data from a post-marketing requirement study comparing the 960-milligram daily dose of LUMAKRAS with a lower dose of 240 milligrams daily in patients with KRAS G12C-mutated advanced non-small cell lung cancer. Following discussions with regulators, we are planning to submit data from this study along with CodeBreaK 200 confirmatory Phase III data.
我們剛剛收到了來自上市後需求研究的初步頂線數據,該研究比較了每天 960 毫克 LUMAKRAS 的劑量與每天 240 毫克的較低劑量的 KRAS G12C 突變的晚期非小細胞肺癌患者。在與監管機構討論後,我們計劃提交本研究的數據以及 CodeBreaK 200 確認性 III 期數據。
As a reminder, we are investigating multiple potential to pass the first-line treatment of non-small cell lung cancer with LUMAKRAS, potentially segmented by PD-L1 expression levels, where the non-small cell lung cancer population breaks down into roughly 1/3s across PD-L1 high expressers, intermediate or low expressers, and PD-L1-negative expression. We've seen promising early data in the PD-L1-negative population and are planning to initiate a Phase III study of LUMAKRAS plus chemotherapy in first-line advanced or metastatic non-small cell lung cancer.
提醒一下,我們正在研究通過 LUMAKRAS 一線治療非小細胞肺癌的多種潛力,可能按 PD-L1 表達水平進行分割,其中非小細胞肺癌人群分解為大約 1/ PD-L1 高表達、中等或低表達和 PD-L1 陰性表達的 3 秒。我們在 PD-L1 陰性人群中看到了有希望的早期數據,併計劃在一線晚期或轉移性非小細胞肺癌中啟動 LUMAKRAS 聯合化療的 III 期研究。
Finally, I'm pleased to announce that the primary analysis of a Phase III study evaluating the efficacy and safety of ABP 938, an investigational biosimilar to EYLEA compared with EYLEA, met its primary end point in subjects with neovascular age-related macular degeneration. With these data and previously announced Phase III data from our biosimilar candidates to SOLIRIS and STELARA, we have completed our goal of delivering positive Phase III data from 3 biosimilars in 2022.
最後,我很高興地宣布,與 EYLEA 相比,評估 ABP 938 的療效和安全性的 III 期研究的主要分析達到了其在新生血管性年齡相關性黃斑變性受試者中的主要終點。憑藉這些數據以及之前公佈的 SOLIRIS 和 STELARA 生物仿製藥候選者的 III 期數據,我們已經完成了在 2022 年提供來自 3 種生物仿製藥的 III 期陽性數據的目標。
In conclusion, with an innovative portfolio where approximately 3/4 of our clinical stage programs have first-in-class potential and a growing portfolio of biosimilars, we are well-positioned to continue to deliver important new medicines for patients and growth for shareholders over the near and long term.
總之,憑藉我們約 3/4 的臨床階段項目具有一流潛力的創新產品組合和不斷增長的生物仿製藥產品組合,我們有能力繼續為患者提供重要的新藥並為股東提供增長近期和長期。
I'll now turn it back to Bob.
我現在把它轉回給鮑勃。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Okay. Thank you, David. And Jason, why don't we now open the line up for questions. If you would remind our callers of the procedure, we can get started.
好的。謝謝你,大衛。傑森,我們現在為什麼不開始提問。如果您提醒我們的呼叫者該程序,我們就可以開始了。
Operator
Operator
(Operator Instructions) Our first question comes from Salveen Richter with 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
On AMG 133 in obesity, could you just help us understand how you'll evaluate the data in the context of existing therapies to make a move forward decision and how you're thinking about differentiation here? Is it just a matter of taking a piece of the market given size? Or do you think there's other aspects here to the program?
關於肥胖症的 AMG 133,您能否幫助我們了解您將如何在現有療法的背景下評估數據以做出向前的決定,以及您如何考慮這裡的差異化?只是在給定規模的市場中分一杯羹?還是您認為該計劃還有其他方面?
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Dave, why don't you take that question?
戴夫,你為什麼不回答這個問題?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. Thanks, Salveen. We know there's a lot of interest in this program. And as we mentioned, we'll be showing the data in full in the first week of December at the hybrid conference. Obesity is a large, very heterogeneous disease. It's a global public health problem.
是的。謝謝,薩爾文。我們知道人們對這個項目很感興趣。正如我們所提到的,我們將在 12 月的第一周在混合會議上完整展示數據。肥胖是一種大而異質的疾病。這是一個全球公共衛生問題。
The things that I would look for in evaluating this molecule going forward will be the dosing; dosing interval; what are the kinetics of weight loss; how rapid is that weight loss; what is sustainability; and then finally, the overall tolerability. We do plan on using our extensive capabilities in human data to help shape our thinking and guide this development program as we move forward.
在評估這種分子的未來時,我會尋找的東西是劑量;給藥間隔;什麼是減肥的動力學;減肥的速度有多快;什麼是可持續性;最後是整體耐受性。我們確實計劃利用我們在人類數據方面的廣泛能力來幫助塑造我們的思維並在我們前進的過程中指導這個開發計劃。
Operator
Operator
Our next question comes from Matthew Harrison with Morgan Stanley.
我們的下一個問題來自摩根士丹利的 Matthew Harrison。
Matthew Kelsey Harrison - Executive Director
Matthew Kelsey Harrison - Executive Director
I wanted to ask a question now that you've been through -- or hopefully been through most of the contracting season for next year. I think one of the key investor concerns is obviously with biosimilar HUMIRA coming next year, what impact that could have to ENBREL and ENBREL pricing dynamics for next year. So I'm wondering if you can just comment on how to think about the potential impact to ENBREL and its pricing next year.
我想問一個問題,你已經經歷了——或者希望你已經經歷了明年的大部分合同賽季。我認為投資者的主要擔憂之一顯然是明年將推出生物仿製藥 HUMIRA,這可能對明年的 ENBREL 和 ENBREL 定價動態產生什麼影響。所以我想知道你是否可以評論一下如何考慮對 ENBREL 的潛在影響及其明年的定價。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Thank you, Matthew. It's Murdo. We're obviously excited about the opportunity to launch the first biosimilar to HUMIRA. And so we are active in our discussions with payers and PBMs for that. We are not seeing a massive amount of change to ENBREL's access going forward, and we continue to believe we've got good regard on the payers and PBMs for the efficacy and the safety of ENBREL.
謝謝你,馬修。是默多。我們顯然對有機會推出首個 HUMIRA 生物仿製藥感到興奮。因此,我們積極與付款人和 PBM 進行討論。我們沒有看到 ENBREL 的訪問權限發生巨大變化,我們仍然相信我們對 ENBREL 的有效性和安全性非常重視付款人和 PBM。
And if there were to be a change in ENBREL pricing, it would be for volume gains. As I mentioned in my opening remarks, we're declining in volumes about 3% year-on-year. Our goal is to maintain that and maybe even improve upon it. But we're not quite finished in the contracting cycle.
如果 ENBREL 定價發生變化,那將是為了增加銷量。正如我在開場白中提到的,我們的銷量同比下降了約 3%。我們的目標是保持這一點,甚至可能對其進行改進。但是我們還沒有完全完成合同周期。
Operator
Operator
Our next question comes from Umer Raffat with Evercore.
我們的下一個問題來自於 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
I have a 2-part question on what everybody wants to talk about, which is obesity. So Lilly and Novo, the 2 lead players in the GLP space, they both have early-stage programs. I'm talking Phase I stage programs on triple agonist, et cetera. And one thing they always emphasize is that they have certain predefined thresholds for moving any of those programs forward. And those thresholds are off of incremental efficacy beyond the current most competitive products out there.
關於每個人都想談論的問題,我有一個兩部分的問題,那就是肥胖。所以禮來和諾和,這兩個 GLP 領域的領頭羊,他們都有早期項目。我說的是三激動劑等的第一階段階段計劃。他們一直強調的一件事是,他們有一定的預定義閾值來推動任何這些程序向前發展。這些閾值超出了目前最具競爭力的產品之外的增量功效。
And my question is, I imagine you're thinking about some of those thresholds too relative to Mounjaro, perhaps CagriSema, as you think about the progression of your program. And I'm curious if you could speak to that. And secondly, if you could just clarify for us, the low- and the high-dose data from single ascending dose you showed at your business review early in the year, was that an average of the first 3 and the highest 3 of the 6 cohorts in Phase I? Or was it the first 2 out of the 6 cohorts? I wasn't quite sure with the low and the high meant within the single ascending dose. And I remember, there were 6 different cohorts within single ascending.
我的問題是,當您考慮程序的進展時,我想您正在考慮一些相對於 Mounjaro 的閾值,也許是 CagriSema。我很好奇你能不能談談。其次,如果您可以為我們澄清一下,您在年初的業務審查中展示的單次遞增劑量的低劑量和高劑量數據是前 3 個和 6 個中最高 3 個的平均值第一階段的隊列?還是 6 個隊列中的前 2 個?我不太確定單次遞增劑量中的低和高意味著什麼。我記得,單次提升中有 6 個不同的隊列。
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. We'll get back to you on the latter half of that question. I'll remember off the top of my head, Umer, what that is. But we're going to have -- in a month, you'll have the full data set with all of the cohorts broken out. So I think, at that point, it will be very clear.
是的。我們將在該問題的後半部分回复您。我會不自覺地記住,Umer,那是什麼。但我們將擁有 - 在一個月內,您將擁有完整的數據集,其中包含所有群組。所以我認為,到那時,情況會非常清楚。
In terms of thresholds, as I discussed a short while ago, there are many potential avenues to differentiation here. Of course, degree of weight loss is one of them; but also dosing interval; what the kinetics are; importantly, durability; importantly, tolerability, since a fair number of patients transition off of these agents for tolerability. So those are the sorts of things that we'll be taking a look at as we assess whether we've got a differentiated product and it's worth large-scale investment.
就閾值而言,正如我剛才討論的那樣,這裡有許多潛在的差異化途徑。當然,減肥程度是其中之一;還有給藥間隔;動力學是什麼;重要的是,耐用性;重要的是,耐受性,因為相當多的患者為了耐受性而放棄這些藥物。因此,當我們評估我們是否擁有差異化產品並且是否值得進行大規模投資時,這些都是我們將要考慮的事情。
Operator
Operator
Our next question comes from Michael Yee with 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
I'm going to ask another follow-up on 133. David, last quarter, you said you actually started the Phase II. I actually didn't hear that here. Can you just talk about the actual status of where you are with 133 and also the fact that I believe it's been disclosed that you dialed back the GLP-1 potency, so we should not be expecting material, diabetes types effects, and this is not what we're looking for or people should be examining or scrutinizing?
我要問另一個關於 133 的後續行動。大衛,上個季度,你說你實際上開始了第二階段。我實際上沒有在這裡聽到。您能否談談您在 133 中的實際情況以及我相信您已調回 GLP-1 效力這一事實已被披露,因此我們不應期待物質、糖尿病類型的影響,這不是我們正在尋找什麼,或者人們應該檢查或審查什麼?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. No, I don't believe we announced we had started Phase II, Mike, but rather that we're in planning. We do expect to initiating the Phase II trial in the relative near term. And once that gets launched, of course, we'll talk about design and give guidance in terms of expected data availability. I wouldn't overthink the GLP-1 component, and I'm not sure that's on point. I think, again, when we share the data in a month, you'll get a look at that.
是的。不,我不相信我們宣布我們已經開始第二階段,邁克,而是我們正在計劃中。我們確實希望在相對近期啟動 II 期試驗。當然,一旦啟動,我們將討論設計並就預期數據可用性提供指導。我不會過度考慮 GLP-1 組件,我不確定這是否正確。我想,再一次,當我們在一個月內分享數據時,你會看到的。
Operator
Operator
Our next question comes from Jay Olson with Oppenheimer.
我們的下一個問題來自傑伊奧爾森和奧本海默。
Jay Olson - Executive Director & Senior Analyst
Jay Olson - Executive Director & Senior Analyst
Congrats on the quarter and closing the ChemoCentryx deal. You have a lot of volume growth outside the U.S. in the third quarter. And as an example, I think you said Repatha grew 73% ex U.S. with inclusion on China's National Drug Reimbursement List. Can you talk about the pace of product launches outside the U.S. and volume growth and how do you expect U.S. versus ex U.S. revenue mix to evolve over time?
祝賀本季度並完成了 ChemoCentryx 交易。第三季度在美國以外的地區有很多銷量增長。舉個例子,我想你說 Repatha 在美國以外增長了 73%,並被列入中國的國家藥品報銷清單。您能否談談在美國以外推出產品的速度和銷量增長,以及您預計美國與美國以外的收入組合將如何隨著時間的推移而演變?
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Do you want to -- yes, jump in.
你想 - 是的,跳進去。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Thanks, Jay. I think Repatha is a good example of how now with our broadened international presence, we're able to bring new products and new launches to the market fairly quickly. What we're seeing in China is rapid expansion of Repatha. Recall, we were on the market for just over a year prior to securing National Reimbursement Drug List. So we did establish good understanding education, awareness of Repatha. We were promoting it primarily for percutaneous coronary intervention patients or stent patients, where the unmet need was deemed to be highest amongst the private cash pay patient group.
謝謝,傑。我認為 Repatha 是一個很好的例子,說明現在隨著我們擴大國際影響力,我們能夠相當快地將新產品和新產品推向市場。我們在中國看到的是 Repatha 的快速擴張。回想一下,在獲得國家報銷藥物清單之前,我們上市僅一年多。所以我們確實建立了良好的理解教育,Repatha的意識。我們主要為經皮冠狀動脈介入治療患者或支架患者推廣它,在這些患者中,未滿足的需求被認為是私人現金支付患者群體中最高的。
But I think what you're seeing is there's real demand in these markets to help millions of patients who are at very high risk of coronary vascular disease. And so we're continuing to build out our business in Japan and China. We had good volume growth in Europe. And obviously, we also had good volume growth in the U.S. So we're excited about the evolution of Repatha, and we continue to feel good about how that product will drive volume and revenue growth for us in the future.
但我認為你所看到的是,這些市場確實需要幫助數百萬處于冠狀血管疾病高風險中的患者。因此,我們將繼續在日本和中國拓展我們的業務。我們在歐洲的銷量增長良好。顯然,我們在美國的銷量增長也不錯。所以我們對 Repatha 的發展感到興奮,我們繼續對該產品將如何推動我們未來的銷量和收入增長感到滿意。
With respect to other launches, the other good example that we're seeing is just the LUMAKRAS launch given that we've got approval in roughly 40 markets, we've got reimbursement in roughly 30 markets, and we're pursuing reimbursement in the remaining countries. Our teams -- our oncology teams around the world doing a very nice job of identifying KRAS G12C second-line patients and making sure that they have LUMAKRAS as a treatment option.
關於其他發布,我們看到的另一個很好的例子就是 LUMAKRAS 發布,因為我們已經在大約 40 個市場獲得批准,我們在大約 30 個市場獲得了報銷,我們正在尋求報銷其餘國家。我們的團隊——我們在世界各地的腫瘤學團隊在識別 KRAS G12C 二線患者並確保他們有 LUMAKRAS 作為治療選擇方面做得非常好。
So I'm really pleased that the international presence we've been building for many years now is in full place, is functioning at a high level and delivering strong volume growth. Going forward, we have some partner products where we don't necessarily have the launches in every country where we have our partners to do that. But wherever Amgen has the global responsibility and rights for products, we're feeling very good about our potential and ability to launch them globally.
所以我真的很高興我們多年來建立的國際影響力已經到位,正在高水平運作並實現強勁的銷量增長。展望未來,我們有一些合作夥伴產品,我們不一定會在我們有合作夥伴這樣做的每個國家推出。但是,只要安進對產品負有全球責任和權利,我們就對我們在全球推出這些產品的潛力和能力感到非常滿意。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
And Jay, let me just add, don't forget, we've -- in the slides that we shared with you this afternoon, we have the outside U.S. data available for you on all the different products. You'll see the current contribution from the international business there.
傑伊,讓我補充一下,不要忘記,我們已經 - 在我們今天下午與您分享的幻燈片中,我們為您提供了所有不同產品的美國境外數據。您將在那裡看到國際業務的當前貢獻。
Operator
Operator
Our next question comes from Geoffrey Meacham with Bank of America.
我們的下一個問題來自美國銀行的 Geoffrey Meacham。
Unidentified Analyst
Unidentified Analyst
This is [Charlie] on for Geoff. Congrats on the results. I just have questions regarding the, I guess, the EYLEA as well as STELARA kind of potential launch timing. I think given you mentioned that you already submitted the STELARA data to the FDA, I'm wondering you're expecting to see the product launch kind of second half of next year and whether you anticipate any pushback from J&J? And I guess similarly kind of for EYLEA, where like launch timing is in the 2024 time frame and if you anticipate kind of any pushback from Regeneron.
這是傑夫的[查理]。祝賀結果。我只是對 EYLEA 和 STELARA 的潛在發佈時間有疑問。我想鑑於您提到您已經向 FDA 提交了 STELARA 數據,我想知道您是否希望看到產品在明年下半年推出,以及您是否預計強生會出現任何阻力?我猜對 EYLEA 也有類似的看法,比如發佈時間是在 2024 年的時間範圍內,如果你預計 Regeneron 會有任何回擊。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Thanks for the question, [Charlie]. We're obviously pleased with the successful data readouts on those products and some that have been filed. We expect to be in the first wave of those biosimilar launches, and we're not disclosing specific launch timing on those products.
謝謝你的問題,[查理]。我們顯然對這些產品和一些已提交的產品的成功數據讀出感到高興。我們預計將在這些生物仿製藥的第一波發布中,我們沒有透露這些產品的具體發佈時間。
Operator
Operator
Our next question comes from Evan Seigerman with BMO Capital.
我們的下一個問題來自 BMO Capital 的 Evan Seigerman。
Evan David Seigerman - MD & Senior BioPharma Research Analyst
Evan David Seigerman - MD & Senior BioPharma Research Analyst
I'm not going to ask about 133 but rather on LUMAKRAS. So you had mentioned you had data from the dose-reduction trial. Can you characterize how we should think about the relative efficacy of the lower doses versus the approved dose? And on the pembro combination trial, I noticed in the slides, you talked about a dose expansion with a lower dose lead-in. Are you also treating in combination with that lower dose?
我不會問 133,而是問 LUMAKRAS。所以你提到你有來自劑量減少試驗的數據。您能否描述一下我們應該如何考慮較低劑量與批准劑量的相對療效?在 pembro 聯合試驗中,我在幻燈片中註意到,您談到了以較低劑量引入的劑量擴展。您是否還與較低劑量聯合治療?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. Thanks, Evan. Look, we understand there's a lot of interest in the dose comparison data. We're just getting the top line results to the FDA and other regulatory authorities. So it's premature to share these data prior to their review and the appropriate conversations.
是的。謝謝,埃文。看,我們知道人們對劑量比較數據很感興趣。我們剛剛向 FDA 和其他監管機構提供了最重要的結果。因此,在審查和適當的對話之前分享這些數據還為時過早。
In regards to the combination trial, I believe you're referring to with checkpoint inhibitors, we're doing a lower dose lead-in, as I've mentioned before, and then layering on top of that dosing the checkpoint inhibitors. So they are then given concurrently going forward.
關於聯合試驗,我相信您指的是檢查點抑製劑,正如我之前提到的,我們正在進行較低劑量的導入,然後在此基礎上添加檢查點抑製劑。因此,它們會在未來同時被給予。
Operator
Operator
Our next question comes from Mohit Bansal with 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
Congrats on the quarter result. So I have a question regarding the 30%-plus year over decline that we have seen with the -- a couple of biosimilars. Is it on expected lives 3 or 4 years after launch? And how should we think about the other biosimilars you have in your portfolio? How should we think about the long-term pricing dynamic there? Because it was an expectation that the pricing would probably stabilize after a certain point, but it doesn't seem like that in biosimilar.
祝賀季度結果。所以我有一個問題,關於我們已經看到的 30% 以上的下降 - 一些生物仿製藥。它在發射後 3 年或 4 年的預期壽命嗎?我們應該如何看待您投資組合中的其他生物仿製藥?我們應該如何看待那裡的長期定價動態?因為預期價格可能會在某個點之後穩定下來,但在生物仿製藥中似乎並非如此。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Thanks for the question, Mohit. I think what's important to remember when you're thinking at least about U.S. biosimilars is products in the buy and bill or medical benefit side will continue to see price declines over time because of the way in which the average selling price calculation works. Products on the pharmacy benefit side, so think Medicare Part D products or commercial-insured retail pharmacy products, they are likely to have slower declines in the slope of their net price over time.
謝謝你的問題,莫希特。我認為,當您至少考慮美國生物仿製藥時,重要的是要記住,由於平均售價計算的方式,購買和賬單或醫療福利方面的產品將繼續看到價格下降。藥房受益方面的產品,因此想想 Medicare Part D 產品或商業保險零售藥房產品,隨著時間的推移,它們的淨價格斜率可能會較慢下降。
Now both of those conditions depend on how many competitors for each molecule. So everyone is a little bit different. But I would hesitate to put a time frame on the class of products. I think you need to look at each one of the molecules. One thing I will say is we've been very clear on where we're going to get growth in our biosimilars portfolio, and that's by launching successive new biosimilars on top of our continuing base of business.
現在,這兩個條件都取決於每個分子有多少競爭者。所以每個人都有點不同。但我會猶豫對產品類別設定時間框架。我認為您需要查看每個分子。我要說的一件事是,我們非常清楚我們將在哪裡獲得生物仿製藥產品組合的增長,那就是在我們持續的業務基礎之上推出連續的新生物仿製藥。
Outside the U.S., biosimilar pricing tends to come down fairly rapidly and then can hold in some of the larger, what we call retail markets. In markets where it's a heavy tender business, prices will continue to decline as long as there are competitors in the market.
在美國以外,生物仿製藥的價格往往會迅速下降,然後可以在一些更大的市場(我們稱之為零售市場)中保持穩定。在招標業務繁重的市場中,只要市場上有競爭對手,價格就會繼續下降。
Operator
Operator
Our next question comes from Yaron Werber with Cowen.
我們的下一個問題來自與 Cowen 的 Yaron Werber。
Yaron Benjamin Werber - MD & Senior Biotechnology Analyst
Yaron Benjamin Werber - MD & Senior Biotechnology Analyst
I got just a couple maybe. David, the first one on 133, can you comment it's an antibody? Can we assume it's monthly dosing? And then secondly, for 938 against EYLEA, now that there's going to be high-dose EYLEA, the 8 milligrams approved, it's obviously the same underlying drug, just a different formulation. How does that impact what you need to do to bring in a high-dose 938 to market and how that jives versus the fiscal year '25 potential launch?
我可能只有一對。大衛,第一個上 133,你能評論它是抗體嗎?我們可以假設它是每月給藥嗎?其次,對於針對 EYLEA 的 938,現在將有高劑量的 EYLEA,8 毫克獲批,它顯然是相同的基礎藥物,只是配方不同。這對您將高劑量 938 推向市場所需的工作有何影響,以及與 25 財年的潛在推出相比,這將如何影響?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. Let me take the first part on 133. It's -- as I said, it's a multispecific or bifunctional molecule, meaning it's got an antibody component that inhibits the GIPR receptor. And then there's a component that agonizes GLP-1. So as you noted, you can expect antibody-like pharmacokinetics, and we'll be sharing all of that in a month. But that's what will drive the dosing interval.
是的。讓我談談 133 的第一部分。正如我所說,它是一種多特異性或雙功能分子,這意味著它含有一種抑制 GIPR 受體的抗體成分。還有一種成分使 GLP-1 痛苦不堪。正如您所指出的,您可以期待類似抗體的藥代動力學,我們將在一個月內分享所有這些。但這就是推動給藥間隔的原因。
On 938, let me ask Murdo to comment briefly on that.
在 938 上,讓我請 Murdo 簡要評論一下。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Yaron, we continue to want to be able to have a full complement of competitive biosimilar products that compete effectively with their innovative parent products. And we've, I think, done that very successfully, thanks to the talented team in our formulation and process development organization. So we feel confident that we'll be able to bring various concentrations across the portfolio as needed. So we're working on that one.
是的。 Yaron,我們繼續希望能夠擁有與其創新的母體產品有效競爭的完整的具有競爭力的生物仿製藥產品。我認為,我們已經非常成功地做到了這一點,這要歸功於我們配方和工藝開發組織中的才華橫溢的團隊。因此,我們相信我們將能夠根據需要在投資組合中帶來各種集中度。所以我們正在研究那個。
Operator
Operator
Next question comes from David Risinger with SVB Securities.
下一個問題來自 SVB 證券的 David Risinger。
David Reed Risinger - Senior MD
David Reed Risinger - Senior MD
So my question is on biosimilars timing for 2023, please. Regarding AMGEVITA, in light of your interchangeability study, which has an estimated completion in January, assuming that succeeds, when in 2023 do you think FDA will add interchangeability to the label?
所以我的問題是關於 2023 年生物仿製藥的時間安排。關於 AMGEVITA,鑑於您的互換性研究預計在 1 月份完成,假設成功,您認為 FDA 何時會在 2023 年為標籤添加互換性?
And then is Amgen planning to launch biosimilar STELARA in September at risk if patent litigation remains outstanding?
如果專利訴訟仍然懸而未決,安進計劃在 9 月推出生物仿製藥 STELARA 是否會面臨風險?
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Thanks again for the question. Maybe take the second part first. We haven't made any statements about when we will launch our biosimilar to STELARA, but we're pleased that we've got strong data in hand, and we're pleased that we've got the strength of the Amgen manufacturing network and commercial organization ready to go. And we'll track that space closely. We expect to be in the first wave of launches on STELARA, EYLEA and SOLIRIS, the next wave of new biosimilar launches.
是的。再次感謝您的提問。也許先拿第二部分。我們尚未就何時向 STELARA 推出我們的生物仿製藥發表任何聲明,但我們很高興我們掌握了強大的數據,我們很高興我們擁有安進製造網絡的實力和商業組織整裝待發。我們將密切跟踪該空間。我們預計將在 STELARA 、 EYLEA 和 SOLIRIS 的第一波發布中,即下一波新的生物仿製藥發布。
And we expect to be in the market in early Feb in the new year with AMGEVITA. The interchangeability stat is an interesting one. I think over time, that may grow in importance. But being first with AMGEVITA, we understand it to be of lower priority from payers and PBMs. But we do expect to have interchangeability in a relevant time frame for when the other biosimilar entrants to HUMIRA come into the market.
我們預計將在 2 月初與 AMGEVITA 一起上市。互換性統計是一個有趣的統計。我認為隨著時間的推移,這可能會變得越來越重要。但首先使用 AMGEVITA,我們理解它在付款人和 PBM 中的優先級較低。但我們確實希望在 HUMIRA 的其他生物仿製藥進入市場時的相關時間範圍內具有可互換性。
Operator
Operator
Next question comes from Robyn Karnauskas with Truist.
下一個問題來自與 Truist 的 Robyn Karnauskas。
Robyn Kay Shelton Karnauskas - Research Analyst
Robyn Kay Shelton Karnauskas - Research Analyst
Just going to follow up with you on the ENBREL comment ahead of the biosimilar HUMIRA launch. We've heard that ENBREL is often used as a third- or second-line TNF. And so I was just curious whether -- you've noted that you don't expect further pricing declines, but that part of it is when ENBREL -- HUMIRA launches that really you're already having to blow through HUMIRA get to ENBREL in many cases, and that's why there may not be motivation to have to compete on price. Just sort of clear -- that's a detailed question. Maybe help me understand the dynamics there.
只是在生物仿製藥 HUMIRA 推出之前與您跟進 ENBREL 評論。我們聽說 ENBREL 通常用作三線或二線 TNF。所以我只是好奇是否——你已經註意到你預計價格不會進一步下降,但這部分是當 ENBREL——HUMIRA 推出時,你真的已經不得不通過 HUMIRA 進入 ENBREL很多情況下,這就是為什麼可能沒有動力必須在價格上競爭。只是有點清楚 - 這是一個詳細的問題。也許可以幫助我了解那裡的動態。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Robyn, thanks for the opportunity to clarify. I didn't say that we don't expect continued price declines on ENBREL. I said we don't expect the current price declines to be dramatically different going into next year. So we do expect to continue to concede price on ENBREL as the category is quite competitive, but we don't see the slope of that changing dramatically.
是的。羅賓,感謝有機會澄清。我沒有說我們預計 ENBREL 的價格不會繼續下跌。我說我們預計明年的當前價格下跌不會有顯著差異。因此,我們確實希望繼續在 ENBREL 上讓步價格,因為該類別具有相當的競爭力,但我們認為其斜率不會發生顯著變化。
And ENBREL is used across a broad range of patient types in rheumatoid arthritis as well as in psoriatic arthritis. I think what we see is we see a lot of frontline usage still, and we do see some post-TNF frontline usage. So I think that will continue. Not every patient is going to respond to TNF inhibitor, and many clinicians prefer the well-demonstrated safety and efficacy profile of ENBREL, and we think that will continue despite biosimilar options in the market. So that hopefully clarifies your question.
ENBREL 用於風濕性關節炎和銀屑病關節炎的廣泛患者類型。我認為我們看到的是我們仍然看到很多前線使用,我們確實看到了一些後 TNF 前線使用。所以我認為這將繼續下去。並非每個患者都會對 TNF 抑製劑產生反應,許多臨床醫生更喜歡 ENBREL 已得到充分證明的安全性和有效性,我們認為儘管市場上有生物仿製藥選擇,這種情況仍將繼續。所以希望能澄清你的問題。
Operator
Operator
Our next question comes from Colin Bristow with UBS.
我們的下一個問題來自瑞銀的 Colin Bristow。
Colin Nigel Bristow - Analyst
Colin Nigel Bristow - Analyst
Congrats on the quarter. So I'll take another one on 133, if I may. As we think about time line, it took Lilly and Novo around 5 to 6 years to move their clips from sort of Phase I initiation to the market. Is there any reason at all for us to think that there's any sort of abbreviated path here that you could explore? And just with those sort of aforementioned time lines in mind and the fact that this efficacy bar that we see now could be raised by what are the competitor assets is ahead of you, does this raise the bar for progression to Phase II from your side?
祝賀本季度。所以如果可以的話,我會在 133 上再拍一張。當我們考慮時間線時,禮來和 Novo 花了大約 5 到 6 年的時間將他們的剪輯從第一階段的啟動轉移到市場。我們有什麼理由認為這裡有任何你可以探索的簡短路徑嗎?考慮到前面提到的那些時間線,以及我們現在看到的這個效率標準可以通過你前面的競爭對手資產來提高這一事實,這是否會提高你進入第二階段的標準?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. Thanks for the question. The -- I think -- let me start with, again, the disease itself, obesity, which is a very heterogeneous disease. Obviously, it's one of the major public health problems globally right now. Our belief is that there are a number of diseases tucked within the label of obesity. Some patients have primarily cardiovascular manifestations; others, type 2 diabetes; others, mechanical problems.
是的。謝謝你的問題。 - 我認為 - 讓我再次從疾病本身開始,肥胖症,這是一種非常異質的疾病。顯然,這是目前全球主要的公共衛生問題之一。我們的信念是,肥胖標籤內隱藏著許多疾病。一些患者主要有心血管表現;其他,2型糖尿病;其他,機械問題。
And so as I noted, we will be using our human data capabilities to further understand and potentially segment these populations to determine if there can be a particular benefit in subsegments of patients. And then I would just remind you of the things that we'll look for in this program as we go forward to see whether we have a differentiated molecule or not, dosing; again, the kinetics, in particular, [habit-ity] and sustainability of weight loss; and then overall tolerability. Those are the things that we'll be looking at as we take a look at Phase II data and determine as the field unfolds where we go from there.
正如我所指出的,我們將利用我們的人類數據能力來進一步了解並可能對這些人群進行細分,以確定患者的子細分市場是否有特別的好處。然後我會提醒你,我們將在這個程序中尋找的東西,因為我們繼續看看我們是否有一個差異化的分子,劑量;再次,動力學,特別是[習慣]和減肥的可持續性;然後是整體耐受性。這些是我們在查看第二階段數據並確定該領域展開時將要研究的內容。
Operator
Operator
Our next question comes from Carter Gould with Barclays.
我們的下一個問題來自於 Barclays 的 Carter Gould。
Carter Lewis Gould - Senior Analyst
Carter Lewis Gould - Senior Analyst
Sorry to beat a dead horse here, but to follow up on the prior question, how important is it that you also pursue diabetes alongside an obesity indication? Or do you feel like you could just go after obesity and that might be able to suffice and work out commercially?
很抱歉在這裡打了一匹死馬,但要跟進前面的問題,你在肥胖症的同時追求糖尿病有多重要?或者你覺得你可以只追求肥胖,這可能就足夠並在商業上有效?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. Thanks, Carter. That's a question we'll address it as we go forward. But I don't feel that it's essential that this be a diabetes medication. As I said, this is -- obesity powers a large number of diseases, and we're going to guide our development to where we think we get the most effect size.
是的。謝謝,卡特。這是我們將在前進過程中解決的問題。但我不認為這是一種糖尿病藥物是必不可少的。正如我所說,這是 - 肥胖會引發大量疾病,我們將把我們的發展引導到我們認為我們獲得最大影響的地方。
Operator
Operator
Our next question comes from Michael Schmidt with Guggenheim.
我們的下一個問題來自古根海姆的邁克爾施密特。
Unidentified Analyst
Unidentified Analyst
This is [CJ] on for Michael. We have one on LUMAKRAS coming out of World conference with updated data on different combinations you presented, I mean, PD-1 and SHIP2. How do you think these different combo regimens can be positioned to develop each other? Do you have any updated view? And would you prioritize one over the other with data so far?
這是邁克爾的[CJ]。我們有一個來自世界會議的關於 LUMAKRAS 的報告,其中包含您提出的不同組合的更新數據,我的意思是,PD-1 和 SHIP2。您認為這些不同的組合方案如何定位以相互發展?你有更新的觀點嗎?到目前為止,您會優先考慮其中一個數據嗎?
David M. Reese - EVP of Research & Development
David M. Reese - EVP of Research & Development
Yes. No, in terms of the combination, SHIP2 checkpoint inhibitor combinations, we're enrolling Phase II trial now with the SHIP2 combination that will guide our development. That's a combination that could potentially be applied regardless of PD-L1 expression levels. And then as I mentioned, we are exploring in the PD-L1-positive population a low-dose run-in of LUMAKRAS then followed by layering on of the checkpoint inhibitor.
是的。不,就組合而言,SHIP2檢查點抑製劑組合,我們現在正在使用將指導我們開發的 SHIP2組合進行 II 期試驗。無論 PD-L1 表達水平如何,這種組合都可能被應用。然後正如我提到的,我們正在 PD-L1 陽性人群中探索 LUMAKRAS 的低劑量磨合,然後分層檢查點抑製劑。
And as those trials enroll, I'll provide guidance in terms of when we have data readouts. And those data will determine how we think about the first-line population. Finally, let me remind everyone again that in the PD-L1-negative population, we're going to be looking at a chemotherapy plus LUMAKRAS combination.
隨著這些試驗的註冊,我將就我們何時讀取數據提供指導。這些數據將決定我們如何看待一線人群。最後,讓我再次提醒大家,在 PD-L1 陰性人群中,我們將研究化療加 LUMAKRAS 組合。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Jason, I see one more participant in the queue. So let's take one last question, after which Bob will make some closing comments.
Jason,我看到隊列中還有一位參與者。因此,讓我們回答最後一個問題,之後 Bob 將發表一些總結性評論。
Operator
Operator
Our final question is from Tim Anderson with Wolfe Research.
我們的最後一個問題來自 Wolfe Research 的 Tim Anderson。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
I wanted to ask a 2-part biosimilar question related just to the U.S. market, and that's what you think uptake will be like in 2 disease areas that are a little different than most. So in the rare disease space, where you'll have a biosimilar SOLIRIS and then in the eye space with your biosimilar EYLEA, how do you think those will compare to disease areas where we already have precedents, such as in oncology? I know the eye space is buy and bill. I think rare diseases is not buy and build, but if you could compare those, please.
我想問一個僅與美國市場相關的由兩部分組成的生物仿製藥問題,這就是您認為在兩個與大多數疾病領域略有不同的疾病領域的吸收情況。因此,在罕見病領域,您將擁有 SOLIRIS 生物仿製藥,然後在眼部領域使用生物仿製藥 EYLEA,您認為這些與我們已經有先例的疾病領域(例如腫瘤學)相比如何?我知道眼睛空間是買單。我認為罕見病不是購買和製造,但如果你能比較一下,請。
Murdo Gordon - Executive VP of Global Commercial Operations
Murdo Gordon - Executive VP of Global Commercial Operations
Yes. Thanks, Tim, for the question. As I mentioned before, you do have to look at each product slightly individually in the circumstances that would generate or drive uptick. If we go back to the oncology biosimilars, we had an assumption at the beginning of those products that patients may not get switched on the maintenance phase of their treatment, so mid-cycle or mid-course of treatment.
是的。謝謝蒂姆的問題。正如我之前提到的,在會產生或推動價格上漲的情況下,您確實必須稍微單獨地查看每種產品。如果我們回到腫瘤學生物仿製藥,我們在這些產品開始時有一個假設,即患者可能不會在治療的維持階段(即治療週期中期或治療中期)切換。
And what we saw, at least in the buy-and-bill space, for both MVASI and KANJINTI that -- was that oncologists were comfortable with the quality of the Amgen biosimilars and by the fact that they had access to our medical teams and our salespeople who are out there calling on them to help them understand the data behind our biosimilars. And so we did see mid-course of treatment switching to our biosimilars.
我們看到,至少在購買和賬單領域,對於 MVASI 和 KANJINTI,腫瘤學家對安進生物仿製藥的質量感到滿意,而且他們可以接觸到我們的醫療團隊和我們的醫療團隊。那裡的銷售人員呼籲他們幫助他們了解我們的生物仿製藥背後的數據。因此,我們確實看到治療的中期轉向我們的生物仿製藥。
So I think the threshold for what we thought would be a hesitancy on the part of the prescriber was different. And I think that we're looking closely at both SOLIRIS prescribers and EYLEA prescribers. And we've done some in-market research with both customer types, and we feel good about our opportunity to create value for the health care system by offering biosimilar alternatives to those 2 branded products. And we feel good about our chances of having a decent uptake on both.
所以我認為我們認為開藥者猶豫的門檻是不同的。我認為我們正在密切關注 SOLIRIS 處方者和 EYLEA 處方者。我們已經對這兩種客戶類型進行了一些市場研究,我們對通過提供這兩種品牌產品的生物仿製藥替代品為醫療保健系統創造價值的機會感到滿意。我們對我們在這兩個方面都有不錯的機會感到滿意。
Robert A. Bradway - Chairman, CEO & President
Robert A. Bradway - Chairman, CEO & President
Okay. Well, again, let me thank all of you for joining our call. We appreciate your interest in Amgen. And let me just end by saying that we remain focused on ending the year strong and positioning ourselves for a good '23 and beyond. We look forward to having a chance to engage with you again here in a few short weeks or Monday and then in a few short weeks thereafter, at various conferences. So thank you and we'll look forward to seeing you soon.
好的。好吧,再次感謝大家加入我們的電話會議。感謝您對安進的興趣。最後讓我說,我們仍然專注於以強勁的勢頭結束這一年,並為 23 歲及以後的美好做好準備。我們期待有機會在短短幾週或週一再次在這裡與您互動,然後在之後的幾週內,在各種會議上與您互動。所以謝謝你,我們期待很快見到你。
Arvind Sood - VP of IR
Arvind Sood - VP of IR
Thanks, everybody.
謝謝大家。
Operator
Operator
This concludes our 2022 Q3 earnings call. You may now disconnect.
我們的 2022 年第三季度財報電話會議到此結束。您現在可以斷開連接。