美國安進 (AMGN) 2022 Q3 法說會逐字稿

內容摘要

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。

完整原文

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

  • Operator

    Operator

  • My name is Jason, and I will be your conference facilitator today for Amgen's Third Quarter 2022 Financial Results Conference Call. (Operator Instructions)

    我是Jason,今天我將擔任安進公司2022年第三季財務業績電話會議的主持人。 (操作說明)

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

    現在我謹介紹投資人關係副總裁阿文德‧蘇德先生。蘇德先生,您可以開始了。

  • 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。謝謝傑森。大家下午好,歡迎參加我們的第三季電話會議。本季我們持續推動各項工作,重點在於推動核心產品的銷售成長,並推動創新產品線的研發。

  • 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.

    今天主持討論的將是我們的董事長兼執行長鮑勃·布拉德韋。我們已發布一些投影片供您參考,並照例提醒各位,我們將做出一些前瞻性陳述,並使用非GAAP財務指標來描述我們的績效。

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

    那麼,接下來我將把電話交給鮑伯。

  • 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。感謝各位參加本次電話會議。面對宏觀經濟和產業特有的挑戰,安進始終專注於為病患和股東創造價值。這項專注的成效在第三季顯而易見,銷量成長了8%,美國以外地區的銷量更是成長了16%。這些業績反映了市場對我們藥品的強勁需求,以及即使在當前充滿挑戰的經濟環境下,我們的藥品仍能為患者帶來價值。

  • 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.

    本季營收下降1%,主要受淨價下降5%的影響(與我們年初公佈的數據一致),以及匯率波動造成的2%的影響。本季,我們共有11款產品創下銷售紀錄,非GAAP每股收益成長15%,自由現金流達28億美元。展望未來,我們將繼續專注於多個成長驅動因素。

  • 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.

    隨著近期對ChemoCentryx的收購完成,我們很高興將TAVNEOS納入我們的產品組合。 TAVNEOS是十多年來首個用於治療ANCA相關性血管炎的新療法,我們相信,憑藉我們在炎症和腎臟病領域數十年的經驗,我們將把這種創新藥物帶給更多患者。

  • 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.

    近期上市的兩款產品TEZSPIRE和LUMAKRAS開局良好。 TEZSPIRE在氣喘治療領域表現優異,我們正在進行此產品其他適應症的研究。 LUMAKRAS在全球也取得了良好的市場表現,病患、付款者和處方醫師都認可了這項創新的重要性。目前,我們正在進行聯合用藥研究,探索該產品未來可能為患者帶來的多種益處。

  • 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%.

    我們擁有多款核心產品,包括Repatha、Otezla、Prolia和EVENITY,我們相信這些產品能夠惠及全球數百萬名患者。此外,我們也不應忽視這四款產品在第三季合計創造了20億美元的銷售額,銷量成長了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相似藥業務,目前已在全球市場推出了 5 款產品,並且距離成為第一家在美國推出 HUMIRA 生物類似藥的公司僅剩幾個月的時間。 AMGEVITA 已經是歐洲處方量最大的 HUMIRA 生物相似藥,這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,我們下一批STELARA、SOLIRIS和EYLEA的生物相似藥已順利完成III期臨床試驗,前景一片光明。我們還有許多潛在的新藥正在透過創新研發管線推進,包括Olpasiran、tarlatamab、rocatinlimab、bemarituzumab和AMG 133。這五種分子以及您稍後將從Dave Reese那裡了解到的其他幾種分子,都是安進的經典之作,它們都是同類首創藥物,能夠為那些亟需新型有效療法的重症患者帶來顯著的改變。

  • 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,我要感謝我們擁有一支高度敬業、盡職盡責的員工隊伍,一如既往地感謝他們的辛勤付出。接下來,我將把發言權交給我們的財務長彼得·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.

    謝謝鮑勃。我們對本季的業績表現感到滿意,並且正朝著實現長期目標穩步前進,其中最重要的是服務患者。我們近期完成對ChemoCentryx的收購,為我們的產品組合新增了一款創新產品-TAVNEOS。 TAVNEOS是目前已核准的同類首創且療效最佳的ANCA相關性血管炎治療藥物。

  • 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2022年業績展望之前,我們先來回顧一下第三季的財務表現。財務表現詳見投影片第6頁。第三季度,我們實現總營收67億美元,較去年小幅下降1%。剔除匯率影響後,總營收和產品銷售額分別成長了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.

    每股收益為 4.70 美元,較我們重述的 2021 年第三季成長 15%。需要注意的是,該業績包含了與我們向協和麒麟株式會社 (KKC) 支付的 AMG 451(rocatinlimab)許可費相關的 4 億美元研發費用。若不計入這 4 億美元的 KKC 授權費,非 GAAP 每股盈餘成長 1%。

  • 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會和您一起回顧產品銷售情況,但我需要重點指出,我們成熟的產品組合創造了近9億美元的銷售額,並持續帶來強勁的現金流,為內部和外部創新提供資金支持。其他收入為4.15億美元,較去年同期成長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營運費用年減8%,主因是2021年第三季向KKC支付了4億美元。若不計入這筆4億美元的預付款,第三季非GAAP營運費用總額年增4%,這反映了我們為提升研發能力和產品線以及支援產品上市而進行的投資。此外,我們的產品銷售額營業利益率為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.

    以非GAAP準則計算,銷售成本佔產品銷售額的百分比年上升0.3個百分點至16.1%,主要原因是產品組合的變化,部分被製造成本的下降以及與新冠病毒抗體出貨量減少相關的成本降低所抵消。剔除4億美元的預付款後,第三季非GAAP研發支出年增10%,主要原因是後期專案支援以及早期研發管線支出增加,部分被已上市產品支援減少所抵銷。

  • 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銷售、管理及行政費用較去年同期成長1%。我們持續專注於優先發展關鍵投資和活動,同時推動生產力提升、自動化和數位轉型。第三季非GAAP營業收入及支出約3.7億美元。這主要是由於淨利息支出增加以及我們因採用權益法核算而需承擔的百濟神州業績份額所致。由於負債管理帶來的收益,我們的營業收入及支出低於預期,但我們預期未來幾季此類收益不會達到相同水準。

  • 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.

    我們擁有穩健的資產負債表,能夠產生可觀的現金流,並保持著充足的財務靈活性,以掌握戰略業務發展機會並落實多項資本配置優先事項。第三季度,我們執行了以下幾項措施:首先,我們近期對ChemoCentryx的收購,正是投資最佳創新成果的鮮明例證,在本例中,該創新成果面向外部患者;其次,我們透過資本支出投資於自身業務,包括推動位於俄亥俄州和北卡羅來納州的新型環保設施的建設;第三,我們透過提高股息向股東返還資本,本季度每股股息為1.94美元,較2021年第三季度增長10%;第四,我們抓住機會進行股票回購。加速股票回購計畫(ASR)的最終結算已於第三季完成,今年迄今為止,我們已回購了約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.

    展望2022年的業務前景,我們對第三季的業績表現感到滿意。根據近期匯率走勢,我們預計全年將受到約5.6億美元的外匯波動影響,其中第三季已消化近4億美元,且已扣除避險活動的影響。

  • 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.

    鑑於我們在第三季的強勁業績,儘管面臨充滿挑戰的外匯市場環境,我們將2022年營收預期上調至260億美元至263億美元。同時,我們將非GAAP每股盈餘預期上調至17.25美元至17.85美元。此預期範圍涵蓋了基於近期匯率波動而產生的約3%(即0.45美元)的全年外匯不利影響,以及我們在完成交易至年底期間因收購ChemoCentryx而產生的相關成本。

  • 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.

    我將分享一些需要考慮的2022年剩餘時間的要點,特別關注這些趨勢可能對第四季產生的影響。我們預期匯率波動將使第四季產品銷售額減少約1.65億美元。美國政府已同意以2.9億美元的價格收購Nplate公司。我們將在第四季確認其中約2億美元的銷售額,剩餘部分將在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.

    我們已完成先前商定的土耳其仿製藥業務 Gensenta 的剝離,並將自 2022 年 11 月 2 日起不再確認該業務的產品銷售額和營運費用。該業務的年銷售額約為 9,000 萬美元。我們現在預計 2022 年全年其他收入將在 15 億美元至 16 億美元之間,高於先前預期的 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.

    與我們重述後的2021年業績相比,我們仍預期全年非GAAP營業費用將年減兩位數。我們仍預期2022年非GAAP營業利潤率(佔產品銷售額的百分比)約為50%。我們仍預期非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研發費用將年減5%至8%,低於我們重述的2021年非GAAP研發費用(其中包括上文所述的4億美元預付款)。我們預計,非GAAP銷售、管理及行政費用佔產品銷售額的比例將與去年基本持平。

  • 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%.

    我們預計營業收入及支出將在16億美元至17億美元之間,第四季業績將與第一季及第二季業績較為接近。全年非GAAP稅率預期為13.5%至14.5%,低於先前14.0%至15.0%的預期。

  • 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,請注意波多黎各於2022年6月頒布的稅法變更,該變更以所得稅取代了波多黎各消費稅(PRET),這將增加我們2023年的所得稅費用,同時大致減少等額的銷售成本。但請注意,2023年將出現一次性的剩餘負面影響,即目前已資本化計入存貨的PRET金額將計入銷售成本,而沒有相應的稅收優惠。該費用略高於我們在2011年實施PRET時確認的稅收優惠,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.

    總而言之,自二月的業務回顧以來,宏觀層面發生了許多變化,包括美元走強、通膨持續高企、利率上升以及《通膨抑制法案》的通過。儘管面臨這些不利因素,我們在2022年依然取得了良好的表現。展望2023年,我們預期這些不利因素仍將持續。我們正在調整營運計劃,並期待能夠成功執行。

  • 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月的第四季財報電話會議上提供2023年業績指引。我們對安進的長期成長依然充滿信心。我衷心感謝數百萬患者的勇氣,也感謝我的25,000名同事每天為這些患者所做的以使命為導向的工作。

  • This concludes the financial update. I'll turn it over to Murdo.

    財務報告到此結束,接下來交給默多。

  • 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Peter。第三季銷量成長強勁,較去年同期成長8%。 11款產品創下季度銷售紀錄,包括EVENITY、TEZSPIRE、AMGEVITA、Vectibix、KYPROLIS、Nplate和BLINCYTO;另幾款產品銷售量實現兩位數成長,包括Repatha和LUMAKRAS。剔除匯率影響,第三季全球產品銷售成長1%,原因是銷售成長被淨售價下降5%所抵消,這與我們先前的預期一致。計入2%的匯率負面影響,產品銷售額較去年同期下降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.

    現在我先介紹一下我們的一般醫藥業務,其中包括Prolia、EVENITY、Repatha和Aimovig。該業務組合的整體營收年增14%,主要得益於銷售量成長20%。在骨骼健康領域,Prolia的銷售額年增7%,主要得益於銷售成長8%。 EVENITY是Prolia在骨骼健康產品組合中的補充,本季銷售額創下2.01億美元的紀錄,主要得益於美國市場銷量增長45%,以及美國以外地區銷量增長30%。

  • 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.

    瑞百安 (Repatha) 的銷售額年增 14%,主要得益於銷量成長 52%,但部分成長被淨售價下降所抵銷。在美國,由於心臟科醫生廣泛採用瑞百安,以及初級保健醫生對該藥的接受度不斷提高,我們的銷量增加了 32%。同時,由於我們提高了回扣以支持更多聯邦醫療保險 D 部分 (Medicare Part D) 和商業保險患者使用該藥,美國市場的淨售價有所下降。

  • 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,我們預期美國市場價格年減幅度將小於2022年。在美國以外地區,Repatha的銷售額成長了26%,主要得益於銷量成長73%。美國以外地區淨價格下降的主要原因是Repatha於2022年1月1日被納入中國國家健保藥品目錄。總而言之,我們將繼續致力於透過向全球有需要的患者提供Repatha,來應對導致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.

    接下來談談我們的發炎產品組合。 Otezla 的銷售額在本季年增 3%。 Otezla 的銷量成長了 9%,部分被庫存下降和不利的匯率影響所抵消。在美國,Otezla 在生物製劑初治銀屑病患者中的市場份額仍然領先,我們看到 Otezla 在輕度至中度銀屑病患者中的應用越來越廣泛。展望未來,鑑於 Otezla 已確立的安全性、強大的醫保覆蓋範圍以及其作為唯一一種能夠治療各種嚴重程度銀屑病患者的全身性口服藥物的獨特地位,我們預計其銷量將繼續保持強勁增長。

  • 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.

    受淨售價下降、銷售預估扣減額不利變化以及銷量下降3%的影響,恩利(ENBREL)第三季銷售額較去年同期下降14%。恩利憑藉其長期療效和安全性記錄,仍然是患者的重要藥物。

  • 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.

    我非常高興TEZSPIRE在美國市場取得了強勁的上市成績,第三季銷售額達到5,500萬美元。過敏科醫生和肺科醫生已將TEZSPIRE用於治療多種重度未控制氣喘患者。我們也看到,過去未接受過生物製劑治療的患者和先前接受過生物製劑治療的患者都在開始使用該藥物。醫生們認可TEZSPIRE獨特的差異化特性及其治療全球250萬重度未控制氣喘患者的巨大潛力,且無需進行任何表型和生物標記檢測。

  • 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.

    我們近期完成了對ChemoCentryx的收購,並將TAVNEOS納入我們的產品組合。 TAVNEOS是近期上市的首個用於治療ANCA相關性血管炎(AAV)的同類首創療法。 AAV是一種嚴重的全身性自體免疫疾病,會導緻小血管發炎並最終破壞。這種發炎性疾病可導致永久性器官損傷,在某些嚴重病例中甚至危及生命。 TAVNEOS的上市,對於每年在美國出現嚴重活動性疾病或經歷AAV重大復發的8000至10000名患者而言,代表著治療領域的一項重大進展。

  • 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臟病學家進行治療,而安進在這些領域擁有強大的市場地位和成功的業績記錄。我們期待運用我們深厚的專業知識和發炎治療經驗,幫助更多患者透過TAVNEOS控制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.

    接下來談談我們的血液腫瘤業務。我們的六款創新產品年增8%,銷量成長10%。 Vectibix和Nplate在本季銷售強勁成長,主要得益於向日本合作夥伴出貨的時機。

  • 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.

    我們的LUMAKRAS產品上市進展順利,第三季營收達7,500萬美元。由於德國健保報銷核准結果導致1,200萬美元的不利價格調整,淨售價降低,較上季銷售額下降3%。但銷量成長15%部分抵銷了這一影響。

  • 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2200名臨床醫生在學術和社區醫療機構為超過3700名患者開立了LUMAKRAS處方。在美國以外,LUMAKRAS目前已在超過45個國家獲得批准。我們已在30個市場推出產品,並正在迅速爭取在其餘市場獲得健保報銷。

  • 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.

    正如我們之前提到的,短期內,LUMAKRAS 的市場主要集中在美國 7,000 名患者和美國以外 20,000 名患者,用於二線治療。從長遠來看,我們預計 LUMAKRAS 的成長將來自早期治療以及其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.

    我們的腫瘤生物相似藥銷售額較去年同期下降了25%。儘管MVASI和KANJINTI的生物相似藥均佔據領先市場份額,但我們預計,受競爭加劇的影響,淨售價將持續惡化,銷售量也將加速下滑。美國市場最新公佈的MVASI平均售價年減了37%,KANJINTI的平均售價較去年同期下降了38%。我們預計,未來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。

  • 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.

    我們正積極籌備於2023年初在美國推出阿達木單抗(HUMIRA)生物相似藥AMGEVITA,隨後也將推出STELARA、EYLEA和SOLIRIS的生物相似藥。整體而言,我對本季的業績表現非常滿意。憑藉我們的國際佈局和多元化的產品組合,我們能夠更好地實現長期成長策略。

  • And with that, I'll turn it over 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. 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 Murdo,大家下午好。首先,歡迎 ChemoCentryx 的新同事們加入安進。我們很高興你們成為安進的一員。在研發方面,第三季我們繼續推動各項工作,公佈了多個專案的新數據,並持續推進我們的創新臨床管線。

  • 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.

    首先,我們來談談內科方面。本週末,我們將在美國心臟協會年會上公佈一項關於 Olpasiran 的 II 期研究數據。 Olpasiran 是一種針對脂蛋白 (a) 的小幹擾 RNA 分子,用於治療 Lp(a) 水平升高的患者。此外,我們還計劃公佈 Repatha FOURIER 研究和 Repatha 開放標籤擴展研究的更多數據,重點闡述顯著且持續地降低和極低 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.

    AMG 133 是一種多特異性藥物,可抑制胃抑制多肽受體 (GIPR) 並活化 GLP-1 受體。其 I 期研究的單劑量和多劑量隊列數據將於 12 月舉行的第 20 屆世界胰島素阻抗、糖尿病和心血管疾病混合會議上公佈。需要強調的是,AMG 133 的獨特之處在於其對 GIPR 的抑製作用。我們選擇採用這種創新方法,是基於人類遺傳學數據,這些數據表明 GIPR 表現降低可降低體重指數和體重。我們期待在 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,並更新 AMG 133 的最新進展。

  • 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.

    接下來談談發炎。 9 月,我們公佈了 III 期 SPROUT 試驗的數據,結果顯示,在 6 至 17 歲兒童中,與安慰劑組相比,Otezla 治療 16 週後顯著改善了中重度斑塊狀銀屑病的各項指標。我們也發表了 Otezla III 期 DISCRETE 試驗的數據,該試驗 16 週的數據顯示,Otezla 治療在改善中重度生殖器乾癬患者的皮膚狀況、搔癢症狀和生活品質方面均取得了統計學意義上的顯著療效。基於這些結果,我們正在與 FDA 討論將 DISCRETE 試驗的臨床數據添加到美國處方資訊中,並即將與全球監管機構就 SPROUT 試驗的相關事宜展開討論。

  • 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在歐盟和日本獲批上市,其他地區的監管審查仍在進行中。在腫瘤學領域,我們發表了tarlatamab的數據,這是一種針對DLL3的BiTE分子,目前正在小細胞肺癌患者中進行研究。這些數據顯示出令人鼓舞的抗腫瘤活性,且具有顯著的療效持久性和存活期延長。在該適應症中,tarlatamab的確認總緩解率為23%,中位緩解持續時間為13個月,中位總存活期為13.2個月。我們正在繼續招募患者參與一項潛在的註冊性II期臨床試驗。

  • 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.

    我們也正在研究 tarlatamab 與一線小細胞肺癌的標準治療方案聯合使用,以及與 PD-1 抑制劑 AMG 404 聯合使用,用於二線或更晚期小細胞肺癌患者和神經內分泌前列腺癌患者。

  • 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,我們發表了LUMAKRAS免疫檢查點抑制劑合併SHIP2治療的研究數據。基於這些數據,我們將繼續探索LUMAKRAS在這兩種治療方案的應用。 9月,我們公佈了LUMAKRAS合併Vectibix治療的數據,該聯合療法在化療難治性轉移性大腸直腸癌患者中展現出令人鼓舞的療效和安全性。目前,一項採用此聯合療法的III期臨床試驗仍在進行中。

  • 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.

    我們也展示了全球III期CodeBreaK 200確證性試驗的數據,該試驗表明,與多西他賽相比,LUMAKRAS治療可顯著提高KRAS G12C突變型非小細胞肺癌患者的無進展生存期和客觀緩解率。患者報告結局方面,LUMAKRAS也優於多西他賽。

  • 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.

    我們剛收到一項上市後要求研究的初步頂線數據,該研究比較了每日960毫克LUMAKRAS劑量與每日240毫克較低劑量在KRAS G12C突變晚期非小細胞肺癌患者中的療效。經與監管機構討論後,我們計劃將研究的數據與CodeBreaK 200的III期確證性數據一併提交。

  • 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.

    再次提醒,我們正在研究多種將LUMAKRAS用於非小細胞肺癌一線治療的方案,這些方案可能根據PD-L1表達量進行分組。非小細胞肺癌患者族群大致可分為三類:PD-L1高表現組、PD-L1低表現組及PD-L1陰性組,每類患者約佔三分之一。我們在PD-L1陰性患者群體中觀察到令人鼓舞的早期數據,並計劃啟動一項LUMAKRAS聯合化療一線治療晚期或轉移性非小細胞肺癌的III期臨床研究。

  • 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,一項評估ABP 938(一種正在研究的EYLEA生物類似藥,與EYLEA相比)在新生血管性老年黃斑部病變患者中療效和安全性的III期研究的主要分析結果達到了其主要終點。憑藉這些數據以及先前發表的SOLIRIS和STELARA生物類似藥候選藥物的III期研究數據,我們已完成在2022年公佈3種生物相似藥積極III期研究數據的目標。

  • 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.

    總而言之,憑藉創新的產品組合(其中約 3/4 的臨床階段項目具有同類首創的潛力)和不斷增長的生物相似藥產品組合,我們有能力在短期和長期內繼續為患者提供重要的新藥,並為股東帶來成長。

  • I'll now turn it back to Bob.

    現在我把麥克風交還給鮑伯。

  • 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,我們現在開始接受提問吧。如果你能提醒來電者們流程,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薩爾文·里希特。

  • 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AMG 133在肥胖症治療的應用,您能否解釋一下,您將如何評估現有療法的數據,從而做出推進決策?您又是如何考慮該療法的差異化的?只是因為市場規模龐大,所以才選擇它嗎?還是您認為該專案還有其他方面需要考慮?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Dave, why don't you take that question?

    戴夫,你來回答這個問題吧?

  • 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。我們知道大家對這個專案很有興趣。正如我們之前提到的,我們將在12月第一週的線上線下混合會議上完整展示數據。肥胖是一種影響範圍很廣、異質性很高的疾病,也是全球性的公共衛生問題。

  • 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.

    接下來,我在評估這種分子時會關注以下幾個方面:給藥劑量;給藥間隔;減重動力學;減重速度;效果的持久性;以及最終的整體耐受性。我們計劃利用我們在人體數據方面的豐富經驗來指導我們的思路,並推動這項研發計劃的進展。

  • Operator

    Operator

  • Our next question comes from Matthew Harrison with Morgan Stanley.

    下一個問題來自摩根士丹利的馬修·哈里森。

  • 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.

    鑑於您已經完成了——或者說希望已經完成了——明年大部分的合約簽訂工作,我想問一個問題。我認為投資人最關心的問題之一顯然是,明年生物相似藥阿達木單抗(HUMIRA)上市後,會對恩利(ENBREL)及其明年的定價動態產生什麼影響。所以我想請您談談如何看待阿達木單抗上市對恩利及其明年定價的潛在影響。

  • 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.

    謝謝馬修。我是默多。我們當然非常高興有機會推出首款阿達木單抗(HUMIRA)生物相似藥。因此,我們正積極與支付方和藥品福利管理機構(PBM)就此進行磋商。我們預期恩利(ENBREL)的進入情況不會發生太大變化,我們仍然相信支付方和藥品福利管理機構對恩利的療效和安全性給予了高度認可。

  • 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.

    如果恩利(ENBREL)的價格要有所變動,那肯定是為了提高銷量。正如我在開場白中提到的,我們的銷量比去年同期下降了約3%。我們的目標是保持這一銷量水平,甚至可能在此基礎上有所提升。但我們目前的合約週期尚未完全結束。

  • Operator

    Operator

  • Our next question comes from Umer Raffat with Evercore.

    我們的下一個問題來自 Evercore 公司的 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.

    我有一個關於肥胖症的問題,這個問題可以分成兩個部分,也是大家都很關心的話題。禮來和諾和諾德是GLP領域的兩大領導企業,它們都有早期研發專案。我指的是處於I期臨床試驗階段的三重激動劑等項目。它們一直強調的一點是,推進這些項目必須達到預先設定的療效閾值。這些閾值是基於療效要超越目前市場上最具競爭力的產品。

  • 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,我想您在考慮專案進度時,可能也會參考 Mounjaro 或 CagriSema 的相關閾值。我很想聽聽您的看法。其次,能否請您澄清一下,您在年初的業務回顧會議上展示的單次遞增劑量低劑量和高劑量數據,是指 I 期臨床試驗中 6 個隊列中前 3 個隊列和劑量最高的 3 個隊列的平均值?還是指 6 個隊列中的前 2 個隊列?我不太確定單次遞增劑量中的低劑量和高劑量具體指的是什麼。我記得,單次遞增劑量試驗共有 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。關於您問題的後半部分,我們稍後會回覆。烏默,我會盡快想起來是什麼。一個月後,您將獲得包含所有隊列的完整資料集。所以我認為,到那時,一切都會非常清楚。

  • 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,這裡有很多潛在的差異化途徑。當然,減重程度是其中之一;但給藥間隔、藥物動力學、持久性以及耐受性也同樣重要,因為相當一部分患者會因為耐受性問題而停用這些藥物。因此,這些都是我們在評估產品差異化及其是否值得大規模投資時會重點關注的面向。

  • Operator

    Operator

  • Our next question comes from Michael Yee with 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

  • 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?

    我還要再問一個關於133的後續問題。 David,上個季度你說你們已經開始了第二期臨床試驗。我在這裡沒聽到。能談談133目前的進展嗎?還有,我記得你們好像已經透露降低了GLP-1的效力,所以我們不應該期待出現嚴重的糖尿病之類的副作用,這也不是我們應該關注或仔細研究的重點。

  • 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,麥克,我不認為我們已經宣布啟動了第二期臨床試驗,而是說我們正在籌備中。我們預計在不久的將來啟動二期臨床試驗。一旦啟動,我們當然會討論試驗設計,並就預期數據可用性提供指導。我不認為應該過度解讀GLP-1部分,而且我不確定這是否切題。我想,一個月後我們公佈數據時,你就會明白了。

  • Operator

    Operator

  • Our next question comes from Jay Olson with 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

  • 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?

    恭喜貴公司本季業績出色,並成功完成對ChemoCentryx的收購。第三季度,貴公司在美國以外的銷售成長顯著。例如,您提到Repatha在美國以外的銷量成長了73%,這得益於其被納入中國國家藥品報銷目錄。能否談談貴公司在美國以外地區的產品上市速度和銷售成長情況,以及您預計未來美國和美國以外地區的收入組成將如何變化?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Do you want to -- yes, jump in.

    你想——是的,跳進去吧。

  • 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,Jay。我認為Repatha就是一個很好的例子,它體現了我們如今拓展國際業務後,能夠迅速將新產品和新上市產品推向市場。我們在中國看到的是Repatha的快速擴張。要知道,在獲得國家健保藥品目錄之前,我們上市僅一年多。因此,我們確實建立了良好的市場認知度和教育基礎。我們主要針對經皮冠狀動脈介入治療或支架植入患者推廣Repatha,因為我們認為自費患者族群中,這類患者的未滿足需求最為迫切。

  • 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,您所看到的是,這些市場確實存在著幫助數百萬冠狀動脈疾病高風險患者的真正需求。因此,我們正在繼續拓展在日本和中國的業務。我們在歐洲的銷售成長良好。顯然,我們在美國也取得了不錯的銷售成長。所以我們對Repatha的發展感到興奮,並且我們仍然相信該產品未來將如何推動我們的銷售和收入成長。

  • 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.

    關於其他藥物上市,我們看到的另一個很好的例子就是LUMAKRAS的上市。目前,我們已在約40個市場獲得批准,在約30個市場獲得醫保報銷,並且正在努力爭取在其餘國家獲得醫保報銷。我們遍佈全球的腫瘤治療團隊在識別KRAS G12C突變的二線治療患者方面做得非常出色,並確保LUMAKRAS能夠成為他們的治療選擇之一。

  • 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.

    因此,我非常高興我們多年來精心構建的國際業務如今已全面展開,高效運作,並實現了強勁的銷售增長。展望未來,我們有一些合作夥伴產品,但我們未必能在每個合作夥伴所在的國家/地區推出這些產品。不過,只要安進擁有產品的全球責任和權益,我們就對在全球推出這些產品的潛力和能力充滿信心。

  • 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,我還要補充一點,別忘了,我們今天下午分享的幻燈片裡,包含了所有不同產品的美國境外數據。你會看到國際業務目前的貢獻。

  • Operator

    Operator

  • Our next question comes from Geoffrey Meacham with Bank of America.

    下一個問題來自美國銀行的傑弗裡·米查姆。

  • 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.

    我是查理,替傑夫問的。恭喜你取得好成績。我有一些關於EYLEA和STELARA潛在上市時間的問題。鑑於你提到已經向FDA提交了STELARA的數據,我想知道你預計該產品會在明年下半年上市,以及你是否預料到強生公司會有任何阻力? EYLEA的情況也類似,它的上市時間預計在2024年左右,你是否預料到再生元公司會有任何阻力?

  • 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.

    謝謝你的提問,[查理]。我們對這些產品以及一些已提交申請的產品的成功數據解讀感到非常滿意。我們預計將成為首批上市的生物相似藥之一,但目前我們不方便透露這些產品的具體上市時間。

  • Operator

    Operator

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

    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?

    我不打算問關於133的問題,而是問關於LUMAKRAS的問題。您之前提到您有劑量遞減試驗的數據。您能否解釋一下我們應該如何看待低劑量與已核准劑量之間的相對療效?關於帕博利珠單抗合併用藥試驗,我注意到您在幻燈片中提到了劑量擴展試驗,並採用了較低劑量的導入期。您是否也採用了這種較低劑量的合併用藥方案?

  • 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。我們明白大家對劑量對比數據非常感興趣。我們目前只是將初步結果提交給FDA和其他監管機構。因此,在他們審核和進行相關討論之前,現在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.

    關於您提到的合併用藥試驗,我相信您指的是免疫檢查點抑制劑,正如我之前提到的,我們會先進行低劑量導入治療,然後再在此基礎上疊加免疫檢查點抑制劑的劑量。因此,它們之後會同時給藥。

  • Operator

    Operator

  • Our next question comes from Mohit Bansal with 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

  • 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.

    恭喜您取得季度業績。我有一個關於幾種生物相似藥年減30%以上的問題。這是基於上市後3到4年的預期壽命嗎?我們該如何看待您產品組合中的其他生物相似藥?我們該如何看待它們的長期定價動態?因為先前預期價格會在某個階段趨於穩定,但生物相似藥似乎並非如此。

  • 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.

    謝謝你的提問,莫希特。我認為,在考慮美國生物相似藥時,需要記住的一點是,由於平均售價的計算方式,醫保報銷或醫療福利方面的產品價格會隨著時間推移而持續下降。而藥局福利方面的產品,例如聯邦醫療保險D部分產品或商業保險零售藥局產品,其淨價的下降速度可能會較慢。

  • 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種分子有多少競爭對手。所以每個情況都略有不同。但我不願為這類產品設定時間表。我認為需要逐一分析每種分子。有一點我可以肯定,我們已經非常清楚生物相似藥產品組合的成長方向,那就是在現有業務的基礎上,不斷推出新的生物相似藥。

  • 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,生物相似藥的價格往往下降得相當快,然後在一些較大的零售市場中能夠保持穩定。在招標競爭激烈的市場,只要市場上有競爭對手,價格就會持續下降。

  • Operator

    Operator

  • Our next question comes from Yaron Werber with Cowen.

    下一個問題來自 Cowen 公司的 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?

    我可能只問了幾個問題。 David,第一個問題是關於133的,你能解釋一下它是一種抗體嗎?我們可以假設它是每月給藥一次嗎?其次,關於938抗EYLEA,既然現在有了高劑量EYLEA(8毫克),顯然它的基礎藥物是相同的,只是劑型不同。這會對你們將高劑量938推向市場產生什麼影響?這與2025財年的潛在上市計畫又有何關聯?

  • 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。我先來說說化合物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,這意味著它包含一個抑制GIPR受體的抗體成分,以及一個激動GLP-1的成分。正如您所指出的,它的藥物動力學特徵與抗體類似,我們將在一個月後分享所有相關資訊。而這正是決定給藥間隔的關鍵因素。

  • On 938, let me ask Murdo to comment briefly on that.

    938,請默多就此簡單評論一下。

  • 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,亞倫,我們一直希望能夠擁有全系列具有競爭力的生物相似藥產品,使其能夠與原廠藥有效競爭。我認為,憑藉我們製劑和製程開發團隊的卓越才能,我們已經非常成功地實現了這一目標。因此,我們有信心根據需要調整產品組合中的不同濃度。我們正在為此努力。

  • 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年生物相似藥的審批時間安排。關於AMGEVITA,鑑於你們的互換性研究預計將於1月完成,假設研究成功,您認為FDA會在2023年的哪個時間點將互換性添加到藥品標籤中?

  • And then is Amgen planning to launch biosimilar STELARA in September at risk if patent litigation remains outstanding?

    那麼,如果專利訴訟懸而未決,安進公司是否計劃在9月推出生物相似藥STELARA,而這又面臨風險呢?

  • 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。或許您可以先回答第二個問題。我們尚未就何時推出STELARA的生物類似藥發表任何聲明,但我們很高興掌握了強有力的數據,也欣慰於安進強大的生產網絡和商業團隊已做好充分準備。我們將密切關注這一領域的進展。我們預計將在STELARA、EYLEA和SOLIRIS這三款新生物相似藥的首批上市中佔有一席之地。

  • 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.

    我們預計新年二月初攜AMGEVITA上市。互換性資料很有意思。我認為隨著時間的推移,它的重要性可能會增加。但由於AMGEVITA是首款上市產品,我們了解到支付方和藥品福利管理機構(PBM)對它的重視程度較低。但我們預計,當其他HUMIRA生物相似藥上市時,我們能夠在適當的時間範圍內實現互換性。

  • Operator

    Operator

  • Next question comes from Robyn Karnauskas with Truist.

    下一個問題來自 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.

    我只是想就您之前關於恩利(ENBREL)的評論,在生物類似藥修美樂(HUMIRA)上市前跟進一下。我們聽說恩利通常被用作治療腫瘤壞死因子(TNF)的二線或三線藥物。所以我很好奇——您曾表示預計價格不會進一步下降,但部分原因是,當修美樂上市時,很多情況下患者已經需要盡快用完修美樂,才能買到恩利,所以可能沒有動力去進行價格競爭。我的問題比較具體,想請您幫我理解其中的原理。

  • 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,Robyn,謝謝你給我這個澄清的機會。我並沒有說我們不預期恩利(ENBREL)的價格會繼續下降。我說的是,我們預計明年目前的降價幅度不會有太大變化。所以,我們確實預期恩利的價格會持續下調,因為這個品類競爭非常激烈,但我們預期降價幅度不會有顯著變化。

  • 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.

    恩利(ENBREL)廣泛應用於類風濕性關節炎和乾癬性關節炎等多種患者類型。我認為目前仍有許多患者將其作為第一線治療藥物,也有一些患者在TNF抑制劑治療後將其作為第一線治療藥物。我認為這種情況會持續下去。並非所有患者都會對TNF抑制劑產生反應,許多臨床醫生更傾向於選擇安全性和有效性都已得到充分驗證的恩利,我們認為即使市面上出現了生物相似藥,這種情況也不會改變。希望我的解釋能解答您的疑問。

  • Operator

    Operator

  • Our next question comes from Colin Bristow with 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

  • 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?

    恭喜貴公司本季業績優異。如果可以的話,我想再問一個關於133的問題。說到時間線,禮來和諾和諾德大約花了5到6年的時間才將他們的產品從I期臨床試驗啟動推向市場。您認為貴公司是否有任何可以探索的更快捷的途徑?考慮到上述時間線,以及目前我們所看到的療效標準​​可能因競爭對手的現有產品而提高,這是否會提高貴公司推進到II期臨床試驗的門檻?

  • 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,謝謝你的提問。我想──還是先從肥胖症本身說起吧,它是一種非常複雜的疾病。顯然,它是目前全球主要的公共衛生問題之一。我們認為,肥胖症這個標籤下隱藏著許多不同的疾病。有些患者主要表現為心血管疾病;有些患者患有第2型糖尿病;還有一些患者有機械性問題。

  • 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.

    正如我剛才提到的,我們將利用我們的人體數據能力,進一步了解並可能細分這些人群,以確定是否能為特定患者群體帶來特定益處。接下來,我想提醒大家,我們將在該專案中重點關注以下幾個方面,以判斷我們是否擁有差異化分子:劑量;再次強調,動力學,特別是體重減輕的習慣性和可持續性;以及整體耐受性。這些都是我們在分析二期臨床試驗數據時會關注的重點,並會根據該領域的發展情況,決定我們下一步的計畫。

  • Operator

    Operator

  • Our next question comes from Carter Gould with Barclays.

    下一個問題來自巴克萊銀行的卡特·古爾德。

  • 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?

    抱歉又老生常談了,但為了跟進先前的問題,您認為在關注肥胖症的同時關注糖尿病有多重要?或者您覺得只專注在肥胖症就足夠了,而且在商業上也能成功?

  • 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。我們會繼續研究這個問題。但我認為它不一定非得是糖尿病藥物。正如我所說,肥胖是許多疾病的誘因,我們將研發方向放在我們認為能獲得最大療效的領域。

  • Operator

    Operator

  • Our next question comes from Michael Schmidt with Guggenheim.

    下一個問題來自古根漢美術館的麥可·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?

    我是[CJ],替Michael問的。我們有一期關於LUMAKRAS的節目,內容來自世界大會,其中包含您之前介紹的不同聯合療法的最新數據,例如PD-1和SHIP2。您認為這些不同的聯合療法如何相互促進發展?有什麼新的看法嗎?根據目前的數據,您會優先考慮哪一種?

  • 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SHIP2檢查點抑制劑聯合療法而言,我們目前正在進行SHIP2聯合療法的II期臨床試驗,該試驗將指導我們的後續研發。這種聯合療法可能適用於任何PD-L1表達水平的患者。正如我之前提到的,我們正在PD-L1陽性人群中探索先使用低劑量LUMAKRAS進行導入治療,然後再疊加使用檢查點抑制劑的方案。

  • 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.

    隨著這些試驗的開展,我會就何時公佈數據提供指導。這些數據將決定我們如何考慮第一線治療族群。最後,我再次提醒大家,對於PD-L1陰性族群,我們將考慮化療合併LUMAKRAS方案。

  • 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.

    傑森,我看到隊伍裡還有一位參與者。那我們來回答最後一個問題,之後鮑伯會做一些總結發言。

  • Operator

    Operator

  • Our final question is from Tim Anderson with Wolfe Research.

    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.

    我想問一個關於生物相似藥的問題,分為兩部分,僅針對美國市場。我想問的是,您認為在兩個與大多數疾病領域略有不同的疾病領域,生物相似藥的市場接受度會如何?在罕見疾病領域,您推出了生物相似藥SOLIRIS,在眼科領域,您推出了生物相似藥EYLEA。您認為這些藥物與我們已有先例的疾病領域(例如腫瘤領域)相比,市場接受度會如何?我知道眼科領域是「先購買後收費」的模式。我認為罕見疾病領域不是「先購買後開發」的模式,但如果您能比較一下這兩個領域的情況,那就太好了。

  • 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。謝謝提姆的提問。正如我之前提到的,確實需要根據具體情況,對每種產品進行更細緻的分析,以判斷其是否會導致銷售成長。以腫瘤生物相似藥為例,我們最初就假設患者可能不會在治療的維持階段(即治療週期中期或療程中期)更換藥物。

  • 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.

    至少在「先買後付」的模式下,我們看到,無論是MVASI還是KANJINTI,腫瘤科醫生都對安進生物類似藥的品質感到滿意,並且認可他們能夠聯繫到我們的醫療團隊和銷售人員,這些人員會主動拜訪他們,幫助他們了解我們生物類似藥背後的數據。因此,我們確實看到一些患者在治療過程中轉而使用我們的生物相似藥。

  • 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,我們之前預想的醫生猶豫不決的閾值有所不同。我們正在密切關注SOLIRIS和EYLEA的處方醫生。我們已經針對這兩類客戶群進行了一些市場調查,並且我們對透過提供這兩種品牌藥的生物相似藥來為醫療保健系統創造價值的機會充滿信心。我們也對這兩種產品都能獲得不錯的市場接受度充滿信心。

  • 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。再次感謝各位參加我們的電話會議。我們非常感謝大家對安進的關注。最後我想說的是,我們將繼續專注於以強勁的勢頭結束今年,並為2023年及以後的發展做好準備。我們期待在幾週後的周一再次與大家交流,並在接下來的幾週內,在各種會議上與大家再次相聚。謝謝大家,期待很快見到你們。

  • 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.

    本次2022年第三季財報電話會議到此結束。您可以斷開連線了。