美國安進 (AMGN) 2022 Q2 法說會逐字稿

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

我是Jason，今天我將擔任安進公司2022年第二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。

Okay, Jason, thank you. Good afternoon, everybody, and welcome to our Q2 call. Lots to cover today, so we'll go ahead and jump right in.

好的，傑森，謝謝。大家下午好，歡迎參加我們的第二季電話會議。今天有很多內容要討論，所以我們直接進入正題。

Some of the key themes you'll hear about today include continued volume-driven growth, our strategy of seeking both internal and external innovation, the latter exemplified by our announcement this morning of acquiring ChemoCentryx. And lastly, navigating through a difficult macro environment. We have posted the slides for your background, we'll use non-GAAP financial measures in our presentation today and some of the statements will be forward-looking. Our SEC filings identify factors that could cause our actual results to differ materially.

今天您將聽到的一些關鍵主題包括：持續的銷售驅動成長；我們尋求內部和外部創新的策略，後者體現在我們今天早上宣布收購ChemoCentryx。最後，我們將探討如何在充滿挑戰的宏觀環境中取得成功。我們已發布相關投影片供您參考，今天的簡報將使用非GAAP財務指標，部分陳述可能涉及前瞻性。我們向美國證券交易委員會（SEC）提交的文件列出了可能導致實際業績與預期有重大差異的因素。

So with that, I would like to turn the call over to our Chairman and CEO, Bob Bradway. Bob?

那麼，接下來我想把電話交給我們的董事長兼執行長鮑伯‧布拉德韋。鮑伯？

Okay. Hello, everyone, and thank you for joining our call. Today, we'll be discussing our second quarter performance as well as our planned acquisition of ChemoCentryx, which all of us here are very excited about.

好的。大家好，感謝各位參加我們的電話會議。今天，我們將討論我們第二季的業績，以及我們計劃收購ChemoCentryx的計劃，我們所有人都對此感到非常興奮。

Starting with our operating results. We delivered strong volume-driven growth in the second quarter with unit volumes increasing 10%. Our innovative products performed well globally. Repatha, Otezla, Prolia and EVENITY all delivered double-digit sales growth in the quarter, while KYPROLIS, Nplate and BLINCYTO in our innovative hematology/oncology portfolio, all generated record quarterly sales.

首先來看我們的營運表現。第二季度，我們實現了強勁的銷量成長，銷量成長了10%。我們的創新產品在全球範圍內表現出色。 Repatha、Otezla、Prolia 和 EVENITY 在本季都實現了兩位數的銷售成長，而我們創新血液/腫瘤產品組合中的 KYPROLIS、Nplate 和 BLINCYTO 也都創下了季度銷售新紀錄。

Our 2 newest products, LUMAKRAS and TEZSPIRE are both off to strong starts. LUMAKRAS is now being prescribed for patients with non-small cell lung cancer in 25 countries around the world. TEZSPIRE has made a big impact in a short period of time for a broad population of patients with severe asthma in the U.S. With our planned acquisition of ChemoCentryx, we'll be adding another newly launched innovative product to our portfolio, TAVNEOS, which is for ANCA-associated vasculitis, which is a serious and sometimes life-threatening autoimmune disease. TAVNEOS is a terrific medicine, the first innovation in this space in more than 10 years and very much needed given the harsh side effects of the older treatments and the seriousness of the disease. This product also fits right in Amgen's strategic sweet spot. Our decades of leadership in immunology and nephrology will enable us to add value to the TAVNEOS launch, reaching many more patients and much more quickly than would otherwise have been possible.

我們最新推出的兩款產品 LUMAKRAS 和 TEZSPIRE 均取得了強勁的開局。 LUMAKRAS 目前已在全球 25 個國家用於治療非小細胞肺癌患者。 TEZSPIRE 在短時間內為美國眾多重度氣喘患者帶來了顯著療效。隨著我們計劃收購 ChemoCentryx，我們將把另一款新上市的創新產品 TAVNEOS 納入我們的產品組合。 TAVNEOS 用於治療 ANCA 相關性血管炎，這是一種嚴重的、有時甚至危及生命的自體免疫疾病。 TAVNEOS 是一款非常優秀的藥物，是該領域十多年來的首個創新產品，鑑於舊療法的副作用嚴重以及該疾病的嚴重性，這款藥物的推出顯得尤為必要。此外，該產品也完全符合安進的策略定位。我們在免疫學和腎臟病學領域數十年的領先地位，將使我們能夠為 TAVNEOS 的上市增添價值，使更多患者受益，速度也比以往更快。

You'll hear from Murdo in a moment, but let me just say that opportunities like this don't come along often. We're really looking forward to working with the highly skilled and committed team from ChemoCentryx to realize the full potential of this very innovative product. We think we can make a difference for patients and earn an attractive return for our shareholders from this investment.

稍後您將聽到默多的發言，但我想先說明，這樣的機會並不常見。我們非常期待與ChemoCentryx公司技術精湛、盡職的團隊合作，充分發揮這款創新產品的潛力。我們相信，這項投資不僅能造福患者，也能為股東帶來可觀的回報。

Dave will talk about the pipeline shortly. Our innovative and biosimilar molecules are proceeding well through the pipeline. Highlights, of course, include the really encouraging data for our cardiovascular molecule, olpasiran, which we expect to move into Phase III testing. On the oncology side, data from our BiTE or bispecifics in several solid tumors are giving us growing confidence in the role these molecules can play in diseases where there are still really big unmet medical needs like small cell lung cancer and prostate cancer. Across the board, our biosimilars are advancing to plan, setting us up for the growth of that business from future launches.

Dave稍後會談到產品線的情況。我們的創新藥物和生物相似藥的研發進展順利。其中最引人注目的是心血管藥物olpasiran的令人鼓舞的數據，我們預計該藥物將進入III期臨床試驗。在腫瘤領域，我們的雙特異性抗體（BiTE）在多種實體腫瘤中的數據讓我們對這些分子在小細胞肺癌和前列腺癌等仍存在巨大未滿足醫療需求的疾病中的作用越來越有信心。整體而言，我們的生物相似藥研發進展順利，為未來產品上市帶來的業務成長奠定了基礎。

Let me now turn to the current drug pricing debate in Washington. By now, it won't surprise you to hear that we're disappointed by the proposed legislation. For some time, we've been advocating for reforms that respect innovation and provide improved access to it. The proposed bill does neither. The bill will impose price controls, and price controls will stymie innovation. At a time when our nation needs more innovation, the result of this bill will be less of it. Adding to the problem, the bill does precious little to improve the affordability of medicines for patients. So when it comes to innovation and affordability, this bill is lose-lose for patients.

現在，我想談談華盛頓目前關於藥品定價的爭論。想必大家已經知道，我們對這項提案感到失望。一段時間以來，我們一直倡導改革，力求尊重創新並改善患者取得藥物的途徑。然而，這項提案卻未能做到這一點。它將實施價格管制，而價格管制會阻礙創新。在我們國家亟需更多創新之際，這項提案的結果只會減少創新。更糟的是，該提案幾乎沒有採取任何措施來提高患者的藥物負擔能力。因此，就創新和可負擔性而言，這項提案對患者來說可謂是雙輸。

Recent developments are no surprise, however. We've been positioning our business for some time for a world of compressed life cycles and prices. And if adopted, this legislation would accelerate those trends, and we'll adapt accordingly. We continue to believe that the world needs more innovation, not less, and our focus will remain on advancing more of it. Across inflammation, oncology and general medicine, we have a broad portfolio of innovative and biosimilar products meeting the needs of patients globally, and we remain encouraged by the prospects for our long-term growth. Through the first half of the year, our team performed well meeting the needs of the patients we serve. I'm grateful to them for their dedication to our mission.

然而，近期的發展並不令人意外。我們早已為產品生命週期縮短和價格下降的世界做好了業務佈局。如果這項立法獲得通過，將會加速這些趨勢，我們將做出相應的調整。我們始終堅信，世界需要更多創新，而不是更少，我們將繼續專注於推動更多創新。在發炎、腫瘤和一般內科領域，我們擁有豐富的創新產品和生物相似藥產品組合，能夠滿足全球患者的需求，我們對公司的長期成長前景充滿信心。今年上半年，我們的團隊表現出色，滿足了我們所服務患者的需求。我衷心感謝他們對我們使命的奉獻。

And let me turn now over to Peter.

現在讓我把麥克風交給彼得。

Thank you, Bob. The CFO organization welcomes ChemoCentryx to Amgen, and we're excited to help enable the teams to serve patients. We are pleased with our performance this quarter, and we're on track to deliver against our long-term objectives. We continue to see the company successfully navigate through foreign exchange headwinds, increasing interest rates, inflation, supply chain pressures and the war in Europe, all while working through COVID variant surges. We're grateful for the hard work of our 24,000 mission-driven colleagues at Amgen and serving our millions of patients around the globe.

謝謝鮑勃。財務長團隊歡迎ChemoCentryx加入安進，我們很高興能夠幫助各團隊更好地服務病患。我們對本季的業績感到滿意，並朝著實現長期目標穩步前進。公司持續成功應對外匯波動、利率上升、通貨膨脹、供應鏈壓力以及歐洲戰亂等挑戰，同時也要應對新冠疫情的反覆爆發。我們衷心感謝安進24,000名以使命為驅動的同事們的辛勤付出，以及他們為全球數百萬患者提供的服務。

I will present our second quarter financial results before discussing our 2022 guidance. The financial results are shown on Slide 6 of the slide deck. We effectively executed in the second quarter with year-over-year volume-driven revenue growth of 1% and product sales growth of 3%. Excluding the impact of foreign exchange, revenue growth and product sales growth were 3% and 5%, respectively. Our EPS growth of 163% versus our recast Q2 2021 is favorably impacted by the $1.5 billion Five Prime in-process R&D expense in 2021. Excluding the $1.5 billion charge for Five Prime, non-GAAP EPS grew 6%.

在討論2022年業績展望之前，我將先介紹我們第二季的財務表現。財務表現詳見投影片第6頁。第二季度，我們有效執行了各項計劃，較去年同期成長1%（主要受銷售驅動），產品銷售額成長3%。剔除匯率影響，營收及產品銷售額分別成長3%及5%。與2021年第二季重述數據相比，我們的每股盈餘成長了163%，這主要得益於2021年Five Prime在研項目15億美元的研發費用。剔除Five Prime的15億美元費用後，非GAAP每股盈餘成長了6%。

Turning to product sales. Strong volume growth of 10% was driven by Repatha, Prolia, LUMAKRAS and EVENITY as well as a number of other products in the portfolio. Year-over-year volume growth was partially offset by declines in net selling price of 6% and foreign exchange headwinds of 2%. Our established product portfolio generated almost $1 billion of product sales and continues to deliver strong cash flows to fund internal and external innovation, just like the ChemoCentryx deal today.

再來看產品銷售。 Repatha、Prolia、LUMAKRAS 和 EVENITY 以及產品組合中的其他一些產品推動了銷售強勁成長，成長 10%。年比銷售成長部分被淨售價下降 6% 和匯率波動帶來的不利影響（2%）所抵銷。我們成熟的產品組合創造了近 10 億美元的銷售額，並持續產生強勁的現金流，為內部和外部創新提供資金支持，正如今天收購 ChemoCentryx 一樣。

Transitioning to our biosimilars. AMGEVITA remains the most prescribed adalimumab biosimilar in Europe, and we are preparing and excited for the U.S. launch of this product in January 2023. Other revenues of about $300 million decreased 24% year-over-year, primarily driven by lower COVID-19 antibody collaboration revenues versus Q2 2021. Non-GAAP operating expenses decreased year-over-year, driven primarily by the $1.5 billion Five Prime related expense in 2021 that I previously mentioned. Recall from our Q1 discussion that we've updated our non-GAAP policy to no longer exclude such expenses from our non-GAAP results in accordance with guidance issued by the SEC this year.

轉型生物類似藥。 AMGEVITA 仍然是歐洲處方量最大的阿達木單抗生物相似藥，我們正積極籌備並期待該產品於 2023 年 1 月在美國上市。其他收入約 3 億美元，年減 24%，主要原因是與 2021 年第二季相比，COVID-19 抗體合作收入下降。非 GAAP 營運支出較去年同期下降，主因是先前提到的 2021 年與 Five Prime 相關的 15 億美元支出。回顧我們第一季的討論，我們已根據美國證券交易委員會 (SEC) 今年發布的指導意見，更新了非 GAAP 政策，不再將此類支出從非 GAAP 業績中剔除。

For comparison purposes, our 2021 non-GAAP operating expenses will now include 2 items that were previously excluded. First, the $1.5 billion recorded in acquired in-process R&D associated with Five Prime in Q2 2021. And next, secondly, $400 million recorded in R&D related to an upfront payment to license rights to AMG 451 from Kyowa Kirin Corporation in Q3 2021. Excluding the impact of the Five Prime in-process R&D $1.5 billion charge in Q2 '21, second quarter total non-GAAP operating expenses declined 5% year-over-year, reflecting continuous improvement driven by digitalization, process simplification and automation, which more than offset investments to advance our pipeline and support product launches.

為了方便比較，我們2021年的非GAAP營運費用將包含先前排除的兩項。首先是2021年第二季計入的與收購Five Prime相關的15億美元在研發研發費用。其次是2021年第三季計入的4億美元研發費用，該費用與向協和麒麟株式會社支付的AMG 451許可費預付款有關。剔除2021年第二季Five Prime在研研發費用15億美元的影響後，第二季非GAAP營運費用總額年減5%，這反映了數位化、流程簡化和自動化帶來的持續改進，這些改進足以抵銷我們為推進產品線和支援產品上市而進行的投資。

On a non-GAAP basis, cost of sales as a percent of product sales decreased 2.2 percentage points on a year-over-year basis to 14.7%, primarily due to lower COVID-19 antibody shipments and direct manufacturing costs, partially offset by evolving product mix. Non-GAAP R&D spend in the second quarter decreased 2% year-over-year, primarily due to lower marketed product support, partially offset by higher spend in research and early pipeline. Non-GAAP SG&A expenses in the second quarter declined 2% year-over-year. We continue to focus on prioritizing key investments and activities while driving productivity.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比年減2.2個百分點至14.7%，主要原因是COVID-19抗體出貨量和直接生產成本下降，部分被產品組合的變化所抵銷。第二季非GAAP研發支出較去年同期下降2%，主要原因是上市產品支援減少，部分被研發和早期管線投入的增加所抵銷。第二季非GAAP銷售、管理及行政費用較去年同期下降2%。我們將繼續專注於優先進行關鍵投資和活動，同時提高生產效率。

Non-GAAP other income and expenses were a net $410 million expense in Q2. This was driven by net interest expense and our share of BeiGene results as a result of our use of the equity method of accounting. We have a strong balance sheet, generate significant cash flow and retain significant financial flexibility to execute strategic business development opportunities. We continue to execute on our capital allocation priorities. First, today's announcement of the acquisition of ChemoCentryx is a great example of investing in the best innovation, whether internal or external. Second, investing in our business through capital expenditures, including for our new environmentally friendly facilities under construction 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 the prior -- from last year's quarter. And fourth, opportunistic share repurchases. And while we had no share buybacks in the second quarter, Q1 2022 at $6.3 billion.

第二季非GAAP其他收入和支出淨額為4.1億美元。這主要受淨利息支出以及由於我們採用權益法核算而產生的百濟神州業績份額的影響。我們擁有穩健的資產負債表，能夠產生可觀的現金流，並保持強大的財務靈活性，以掌握策略性業務發展機會。我們將繼續推進資本配置優先事項。首先，今天宣布收購ChemoCentryx公司，正是投資最佳創新（無論內部或外部）的絕佳例子。其次，我們透過資本支出投資自身業務，包括正在俄亥俄州和北卡羅來納州建設的新型環保設施。第三，我們透過提高股利向股東返還資本，本季每股派息1.94美元，較去年同期成長10%。第四，我們把握時機進行股票回購。雖然我們在第二季沒有進行股票回購，但預計2022年第一季將回購63億美元。

Let's turn to the outlook for the business for 2022. We are pleased with our progress through the first half of 2022, and we continue to be confident in the trajectories of our growth brands. For the full year, we now expect to absorb $500 million in foreign exchange headwinds against product sales based on recent foreign exchange rates, of which we absorbed $200 million in the first half of the year. Reflecting our effective execution to date, while considering the challenging foreign exchange dynamics, we're narrowing our 2022 revenue guidance range to $25.5 billion to $26.4 billion. Our non-GAAP EPS range of $17 to $18 remains unchanged. This range encompasses foreign exchange headwinds of approximately 3% or $0.45 for the full year, based on recent foreign exchange rates. Of that $0.45, we experienced approximately $0.20 in the first half of the year, so we anticipate an additional $0.25 in foreign exchange headwinds against EPS in the second half of the year. Our non-GAAP EPS range also encompasses costs associated with our acquisition of ChemoCentryx. Both foreign exchange and ChemoCentryx will influence our performance within the range.

讓我們展望一下2022年的業務前景。我們對2022年上半年的進展感到滿意，並持續對旗下成長品牌的未來發展充滿信心。根據近期匯率，我們預計全年將受到5億美元的外匯不利影響，其中2億美元已在上半年計入。考慮到我們迄今為止的有效執行，以及充滿挑戰的外匯市場環境，我們將2022年營收預期範圍縮小至255億美元至264億美元。我們的非GAAP每股盈餘預期範圍維持在17美元至18美元不變。此預期範圍已包含約3%（即0.45美元）的全年外匯不利影響（基於近期匯率）。在這0.45美元中，上半年我們大約承受了0.20美元的匯率波動影響，因此我們預計下半年每股收益將額外受到0.25美元的匯率不利影響。我們的非GAAP每股盈餘預期範圍也包含了收購ChemoCentryx的相關成本。匯率波動和ChemoCentryx的收購都會對我們在該預期範圍內的業績產生影響。

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 Q3 and Q4. First, we expect foreign exchange headwinds against product sales in Q3 and Q4 of approximately $150 million in each quarter, for a total of $300 million for the second half of the year. These headwinds are most pronounced in brands with significant ex U.S. scale, such as Prolia, Aranesp, AMGEVITA, Vectibix and XGEVA. Second, anticipated negative pricing trends for MVASI and KANJINTI are expected to continue in the second half of the year. And we expect quarter-over-quarter product sales declines in those products for the remainder of the year. We expect KANJINTI sales for the year of roughly $300 million and MVASI sales for the year of roughly $850 million. As we've noted, growth in biosimilars will be driven by the addition of new products and geographies, and we look forward to being the first biosimilar to HUMIRA, the launch in the United States, with AMGEVITA in January 2023. Third, we expect Q3 ENBREL product sales to approximate Q2 ENBREL product sales. Four, for the full year, we now expect Neulasta product sales to be between $1.0 billion to $1.1 billion. This is a change from our previous range of $0.9 billion to $1.0 billion. We expect the negative pricing trends for Neulasta will continue in the second half of the year. Fifth, although we expect the net impact of these factors will result in Q3 revenues and EPS lower than Q2, I would reiterate that our full year EPS guidance remains unchanged at $17 to $18. We now expect other revenue for 2022 to be in the range of $1.4 billion to $1.6 billion versus our prior range of $1.4 billion to $1.7 billion. Our expectations for total non-GAAP operating expenses for 2022 are unchanged from the last time we spoke. We continue to expect that operating expenses will increase in the second half of the year versus the first half of this year, including important investments in our pipeline as well as both current and upcoming launches, again, including AMGEVITA in January '23 and increasing R&D spend in the third and the fourth quarter. We continue to expect 2022 non-GAAP operating margin as a percent of product sales to be roughly 50%. We continue to expect non-GAAP cost of sales as a percent of product sales to be 15.5% to 16.5%. Our expectations for non-GAAP R&D in 2022 remain unchanged, based on our recast 2021 results, which now include $400 million of expense in Q3 related to the license with KKC for AMG 451, our expected 2022 non-GAAP R&D expense now equates to a decrease of 4% to 6% year-over-year. We expect non-GAAP SG&A spend to be flat to slightly down year-over-year as a percent of product sales. We continue to expect other income and expenses to be in the range of $1.6 billion to $1.8 billion, with an increase in Q3 over the run rate of the first 2 quarters due to both increasing interest rates and our share of BeiGene's results.

我將分享一些需要考慮的要點，尤其是在2022年剩餘時間裡，並專注於這些趨勢可能對第三季和第四季產生的影響。首先，我們預期外匯波動將對第三季和第四季的產品銷售造成約1.5億美元的不利影響，下半年總計將造成約3億美元的損失。這些不利影響在Prolia、Aranesp、AMGEVITA、Vectibix和XGEVA等在美國以外市場規模較大的品牌中最為顯著。其次，我們預期MVASI和KANJINTI的價格下行趨勢將在下半年持續。我們預計這些產品在今年剩餘時間內的季度銷售額將會下滑。我們預計KANJINTI全年銷售額約為3億美元，MVASI全年銷售額約8.5億美元。正如我們先前提到的，生物相似藥的成長將主要得益於新產品和新市場的拓展，我們期待成為首個在美國上市的阿達木單抗（HUMIRA）生物相似藥——安吉維他（AMGEVITA），預計將於2023年1月上市。第三，我們預期第三季恩利（ENBREL）產品的銷售額將與第二季基本持平。第四，我們現在預計紐拉司他全年（Neulasta）產品的銷售額將在10億美元至11億美元之間，這與我們先前預測的9億美元至10億美元有所不同。我們預計紐拉司他的價格下跌趨勢將在下半年持續。第五，儘管我們預期這些因素的綜合影響將導致第三季營收和每股盈餘低於第二季度，但我仍要重申，我們全年每股盈餘預期維持不變，仍為17美元至18美元。我們現在預計2022年其他收入將在14億美元至16億美元之間，低於先前預期的14億美元至17億美元。我們對2022年非GAAP營運總支出的預期與上次溝通時保持一致。我們仍預計，下半年營運支出將高於上半年，這包括對產品線的重要投資，以及目前和即將推出的產品，例如將於2023年1月上市的AMGEVITA，以及第三季和第四季研發投入的增加。我們仍預期2022年非GAAP營運利潤率（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）為15.5%至16.5%。基於我們重述的2021年業績，我們對2022年非GAAP研發支出的預期維持不變。重述後的業績現已包含第三季與KKC就AMG 451授權相關的4億美元支出。因此，我們預計2022年非GAAP研發支出將年減4%至6%。我們預期非GAAP銷售、管理及行政費用佔產品銷售額的比例將與前一年持平或略有下降。我們繼續預期其他收入和支出將在16億美元至18億美元之間，第三季將高於前兩個季度的水平，這主要歸因於利率上升以及我們分得的百濟神州的業績份額。

And finally, for the full year, we anticipate a non-GAAP tax rate range of 14.0% to 15.0%, up from our prior guidance of 13.5% to 14.5%. We will effectively execute throughout the remainder of 2022, despite the continuing headwinds. We will continue investing in the best innovation. We look forward to the launch of AMGEVITA in January '23, driving the launches of TEZSPIRE and LUMAKRAS, progressing our pipeline, successfully integrating ChemoCentryx and delivering on our 2030 objectives.

最後，我們預期全年非GAAP稅率區間為14.0%至15.0%，高於先前13.5%至14.5%的預期。儘管面臨持續的挑戰，我們仍將在2022年剩餘時間內有效執行各項計畫。我們將繼續投資最佳創新。我們期待AMGEVITA於2023年1月上市，推動TEZSPIRE和LUMAKRAS的上市，推進產品線，成功整合ChemoCentryx，並實現我們的2030年目標。

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

財務更新到此結束。接下來交給默多。默多？

Thanks, Peter. Second quarter product sales increased 3% year-over-year, driven by a 10% volume increase. Excluding the impact of foreign exchange, global product sales grew 5%. We delivered record quarterly sales for Prolia, EVENITY, AMGEVITA, KYPROLIS, Nplate and BLINCYTO, and delivered double-digit volume growth for several additional products, including Repatha and LUMAKRAS. Our ex U.S. business grew 5% with volume growth of 20% year-over-year. In addition to the strong second quarter, I'm also personally excited about our announcement to acquire ChemoCentryx and the opportunity to help patients with severe active ANCA-associated vasculitis, a serious and potentially life-threatening autoimmune disease. I'll say more about TAVNEOS as I comment on the performance of our inflammation portfolio.

謝謝，Peter。第二季產品銷售額年增3%，主要得益於銷售成長10%。剔除匯率影響，全球產品銷售額成長5%。 Prolia、EVENITY、AMGEVITA、KYPROLIS、Nplate 和 BLINCYTO 的季度銷售額均創歷史新高，Repatha 和 LUMAKRAS 等其他幾款產品的銷售量也實現了兩位數成長。除美國以外，我們的業務成長了5%，銷量較去年同期成長20%。除了強勁的第二季業績，我個人也對我們宣布收購 ChemoCentryx 感到興奮，這讓我們有機會幫助患有嚴重活動性 ANCA 相關性血管炎的患者，這是一種嚴重的、可能危及生命的自身免疫性疾病。關於 TAVNEOS，我將在評論我們發炎產品組合的表現時再做詳細介紹。

I'll start with our general medicine business, which includes Prolia, EVENITY, Repatha and Aimovig. Overall revenue for this portfolio grew 17% year-over-year, driven by 24% volume growth. In bone health, Prolia sales grew 13% year-over-year. Volumes grew 12%, driven by an increase in both new and repeat patients. EVENITY had record sales of $191 million for the quarter, driven by 60% volume growth in the U.S. and 37% volume growth outside of the U.S. ENBREL sales decreased 8% year-over-year for the second quarter, primarily driven by declines in net selling price and volume. ENBREL remains a frequently prescribed therapy due to its long track record of efficacy and safety.

首先，我將介紹我們的普通內科業務，其中包括Prolia、EVENITY、Repatha和Aimovig。該業務組合的整體營收年增17%，主要得益於銷售量成長24%。在骨骼健康領域，Prolia的銷售額年增13%，銷售量成長12%，主要得益於新患者和復診患者的增加。 EVENITY本季銷售額創下1.91億美元的紀錄，主要得益於美國市場銷售成長60%，美國以外市銷售成長37%。 ENBREL第二季銷售額年減8%，主因是淨售價和銷售量雙雙下滑。由於ENBREL長期以來療效顯著且安全性高，因此仍是常用的治療藥物。

Our launch of TEZSPIRE is off to a very strong start with $29 million in sales in the second quarter. I'm encouraged to see that both 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. On the access front, TEZSPIRE is a medical benefit product for which we received permanent reimbursement coding as of July 1. 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 or biologic-eligible without any phenotypic and biomarker limitation.

TEZSPIRE上市開始開始就取得了非常強勁的開局，第二季銷售額達2900萬美元。令人欣慰的是，過敏科醫生和肺科醫生都已將TEZSPIRE處方給眾多重度未控制氣喘患者。我們也看到，無論是初次使用生物製劑的患者或是既往接受過生物製劑治療的患者，都在開始使用TEZSPIRE。在藥品可及性方面，TEZSPIRE是一款醫療福利產品，我們已於7月1日取得永久報銷編碼。醫生們認可TEZSPIRE獨特的差異化特性及其廣泛的治療潛力，能夠幫助全球250萬重度氣喘患者（無論其病情控制如何，或符合生物製劑治療條件），且不受任何表型和生物標誌物的限制。

Now our agreement to acquire ChemoCentryx brings a compelling opportunity into our leading inflammation and nephrology portfolio with TAVNEOS, a recently launched first-in-class treatment for ANCA-associated vasculitis, or AAV. Let me take a minute to talk about how important I think TAVNEOS will be for patients. AAV is a serious systemic autoimmune disease. It leads to inflammation and eventual destruction of small blood vessels. And this inflammatory process can lead to permanent organ damage and, in some severe cases, can be life-threatening. TAVNEOS represents a significant advance in the treatment options for the 8,000 to 10,000 U.S. patients a year who develop severe active disease or experience major relapses of AAV. We're looking forward to meeting and working with the talented team at ChemoCentryx and I'm confident that by applying Amgen's deep experience in inflammation and nephrology and substantial market presence, we can help many more patients with AAV with TAVNEOS.

現在，我們與ChemoCentryx達成的收購協議，為我們領先的發炎和腎臟病產品組合帶來了一個極具吸引力的機會，其中包括TAVNEOS——一種近期上市的、針對ANCA相關性血管炎（AAV）的首創療法。我想花一點時間談談我認為TAVNEOS對病人的重要性。 AAV是一種嚴重的全身性自體免疫疾病。它會導致炎症，並最終破壞小血管。這種發炎過程會導致永久性器官損傷，在一些嚴重病例中甚至會危及生命。 TAVNEOS的出現，為每年8000至10000名在美國患有嚴重活動性疾病或經歷AAV重大復發的患者提供了治療選擇上的重大突破。我們期待與ChemoCentryx的優秀團隊會面並合作，我相信，憑藉安進在發炎和腎臟病領域的深厚經驗和強大的市場影響力，我們能夠利用TAVNEOS幫助更多AAV患者。

Moving to our hematology and oncology business. Our 6 innovative products grew 14% year-over-year with 11% volume growth. This was driven by strong volume growth for KYPROLIS, Nplate and BLINCYTO, which we expect to continue throughout this year. XGEVA volume declined 2% in Q1 and was flat year-over-year in Q2. Our launch of LUMAKRAS is progressing well with revenues of $77 million in the second quarter, representing 24% quarter-over-quarter growth. In the U.S., LUMAKRAS has been prescribed to over 3,000 patients by over 1,900 physicians, and we've seen broad adoption in the community setting where the majority of non-small cell lung cancer patients are treated. Unfortunately, while 85% of patients in the U.S. are tested for their KRAS G12C status, only 50% of the time do oncologists have these test results available to support second-line treatment decisions. And our teams are removing barriers to ensure that the oncologist is able to review KRAS G12C status when the patient progresses beyond first-line therapy. And we've seen that when the KRAS G12C status is known in the second-line setting, 85% of patients receive LUMAKRAS. Outside the U.S., LUMAKRAS has now been approved in over 40 countries, and we're actively launching in 25 markets and rapidly pursuing reimbursement in the remaining countries.

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14%，銷量成長11%。這主要得益於KYPROLIS、Nplate和BLINCYTO的強勁銷售成長，我們預計這一成長動能將持續到今年年底。 XGEVA的銷量在第一季下降了2%，第二季與去年同期持平。 LUMAKRAS的上市進展順利，第二季營收達7,700萬美元，較上季成長24%。在美國，超過1900名醫生已為超過3000名患者開立了LUMAKRAS處方，並且在大多數非小細胞肺癌患者接受治療的社區醫療機構中，我們看到了該藥物的廣泛應用。遺憾的是，儘管美國有85%的患者接受了KRAS G12C狀態檢測，但腫瘤科醫師只有50%的時間能夠獲得這些檢測結果來支持二線治療方案的發展。我們的團隊正在努力消除障礙，確保腫瘤科醫師能夠在患者接受第一線治療後病情進展時評估KRAS G12C狀態。我們發現，在二線治療中，如果已知KRAS G12C狀態，85%的患者會接受LUMAKRAS治療。目前，LUMAKRAS已在美國以外的40多個國家獲得批准，我們正在積極推動25個市場的上市，並迅速爭取在其餘國家獲得醫療保險報銷。

Sales of our oncology biosimilars declined 24% year-over-year, while our biosimilars for MVASI and KANJINTI both hold leading shares. We expect continued net selling price deterioration and volume declines, driven by increased competition. In total, our biosimilars portfolio has become an industry-leading franchise, which has contributed $5.5 billion of product sales cumulatively. Looking forward, we're excited about the upcoming launch of AMGEVITA in the United States in January of 2023, followed by the next wave of biosimilar launches to STELARA, EYLEA and SOLIRIS.

我們的腫瘤生物相似藥銷售額年減了24%，但MVASI和KANJINTI的生物相似藥仍佔領先市場。我們預計，受競爭加劇的影響，淨售價將持續下降，銷售量也將持續下滑。整體而言，我們的生物相似藥產品組合已成為業界領先的產品線，累計銷售額達55億美元。展望未來，我們對AMGEVITA將於2023年1月在美國上市感到興奮，隨後也將推出STELARA、EYLEA和SOLIRIS的生物相似藥。

Overall, I'm very pleased with our execution and volume growth in the quarter, our expanding international presence and diverse portfolio of products, including the exciting addition of TAVNEOS position us well to deliver on our long-term growth strategy.

總體而言，我對本季的執行情況和銷售成長非常滿意，我們不斷擴大的國際業務和多樣化的產品組合，包括令人興奮的 TAVNEOS 的加入，使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。

Thanks, Murdo. Good afternoon, everyone. I'd like to start by sharing my excitement for the transaction we announced today. As you've heard, ANCA-associated vasculitis is a serious and sometimes life-threatening disorder. Having treated these patients personally, I fully appreciate the challenges they face and the benefits of TAVNEOS in addressing this significant unmet need. I look forward to working with the team at ChemoCentryx.

謝謝，默多。大家下午好。首先，我想和大家分享一下我對今天宣布的交易的興奮。如大家所知，ANCA相關性血管炎是一種嚴重的、有時甚至危及生命的疾病。我曾親自治療過這些患者，因此我完全理解他們面臨的挑戰，也深知TAVNEOS在滿足這項重大未滿足需求方面所帶來的益處。我期待與ChemoCentryx團隊合作。

For research and development, the second quarter was one of continued execution where we announced new data on several programs and continued to progress our robust innovative clinical pipeline.

在研發方面，第二季度是繼續執行的季度，我們公佈了幾個專案的新數據，並繼續推進我們強大的創新臨床研發管線。

Beginning with inflammation. In July, TEZSPIRE was recommended for approval in the European Union by the Committee for Medicinal Products for Human Use for severe asthma and also approved in Canada. We initiated the SUNRISE Phase III study designed to assess the efficacy and safety of TEZSPIRE in reducing oral corticosteroid use in adults with oral corticosteroid-dependent asthma. The ROCKET Phase III program evaluating rocatinlimab, an innovative anti-OX40 monoclonal antibody, in patients with moderate to severe atopic dermatitis was initiated in June. Following additional discussions with regulators and our partner, we are amending the studies to further improve patient convenience and investigate a range of doses. No safety or efficacy issues have arisen. We continue to remain very excited about the broad potential of this program in atopic dermatitis.

從發炎入手。今年7月，TEZSPIRE獲得歐盟人用藥品委員會（CMPI）推薦批准用於治療重度氣喘，並在加拿大獲得批准。我們啟動了SUNRISE III期臨床試驗，旨在評估TEZSPIRE在減少口服糖皮質激素依賴型氣喘成人患者口服糖皮質激素用量的療效和安全性。 6月，我們啟動了ROCKET III期臨床試驗，評估創新型抗OX40單株抗體rocatinlimab在治療中重度異位性皮膚炎患者的療效。在與監管機構和合作夥伴進行進一步討論後，我們正在修訂研究方案，以進一步提高患者的用藥便利性並探索不同的劑量範圍。目前尚未出現任何安全性或療效問題。我們對該計畫在異位性皮膚炎治療領域的巨大潛力仍然充滿信心。

In oncology, we will present data from two of our thoracic programs at the upcoming World Conference on Lung Cancer. The first is tarlatamab, a DLL3-targeting HLE BiTE molecule, being studied in heavily pretreated patients with small cell lung cancer, a population with few treatment options. In this setting, tarlatamab demonstrated promising antitumor activity with notable response durability. We look forward to presenting an updated data set at World Conference and continue to enroll patients in a potentially registrational Phase II trial in this study -- in this setting.

在腫瘤學領域，我們將在即將召開的世界肺癌大會上公佈兩項胸腔外科計畫的數據。第一項是tarlatamab，一種針對DLL3的HLE BiTE分子，目前正在小細胞肺癌患者中進行研究，這類患者的治療選擇非常有限。在此類患者中，tarlatamab展現出令人鼓舞的抗腫瘤活性，且療效持久。我們期待在世界大會上公佈更新的數據，並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。

I'll also present data from our LUMAKRAS checkpoint inhibitor and SHIP2 combination studies. Data from the former are embargoed until August 7, so we can't discuss the results today. What we can say is that PD-1s have been challenging to combine with other targeted agents due to tolerability issues. We will present a comprehensive data set from this study. As a reminder, we are investigating multiple potential paths to 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 1/3's across PD-L1 high expressers, low expressers and PD-L1 negative expression. We've seen promising early data in the PD-L1 negative population. And based on discussions with regulators, we are planning to initiate a Phase III study of LUMAKRAS plus chemotherapy in first-line advanced or metastatic non-small cell lung cancer.

我也會介紹我們LUMAKRAS檢查點抑制劑和SHIP2合併用藥研究的數據。前者的數據要到8月7日才公佈，所以我們今天無法討論結果。我們可以說的是，由於耐受性問題，PD-1抑制劑與其他標靶藥物聯合使用一直具有挑戰性。我們將展示這項研究的完整數據集。再次提醒大家，我們正在探索LUMAKRAS一線治療非小細胞肺癌的多種潛在途徑，並可能根據PD-L1表現量進行分組。非小細胞肺癌患者大致可分為PD-L1高表現、低表現及PD-L1陰性三組。我們在PD-L1陰性族群中看到了令人鼓舞的早期數據。基於與監管機構的討論，我們計劃啟動一項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。

While a smaller data set, we are very encouraged by both the efficacy and safety of the LUMAKRAS combination with Revolution Medicines' SHIP2 inhibitor RMC-4630. In patients without prior KRAS G12C inhibitor treatment, 3 of 4 patients with non-small cell lung cancer who received the highest 2 doses of RMC-4630 in combination with LUMAKRAS had a confirmed partial response and all 4 had disease control.

儘管樣本量較小，但我們對LUMAKRAS合併Revolution Medicines公司的SHIP2抑制劑RMC-4630的療效和安全性感到非常鼓舞。在先前未接受過KRAS G12C抑制劑治療的非小細胞肺癌患者中，4例接受最高2個劑量RMC-4630合併LUMAKRAS治療的非小細胞肺癌患者中有3例達到確認的部分緩解，且所有4例患者的病情均得到控制。

In gastrointestinal cancer, we are also pleased to announce the data from the full dose expansion Phase Ib study of LUMAKRAS in combination with Vectibix in refractory KRAS G12C mutated colorectal cancer were accepted for presentation at the European Society for Medical Oncology Congress taking place in September. The final analysis of the FIGHT study, Phase II randomized, double-blind, controlled trial evaluating bemarituzumab, a fibroblast growth factor receptor 2b, FGFR2b, targeting monoclonal antibody, and modified FOLFOX6 in patients with previously untreated advanced gastric and gastroesophageal junction cancer was completed. These results continue to demonstrate the bemarituzumab plus modified FOLFOX6 improves the clinical outcome of patients with FGFR2b-expressing tumors with no new safety concerns. A greater survival benefit was observed with increasing levels of FGFR2b expression.

在胃腸道腫瘤領域，我們很高興地宣布，LUMAKRAS聯合Vectibix治療難治性KRAS G12C突變型結直腸癌的Ib期全劑量擴展研究數據已被歐洲腫瘤內科學會（ESMO）接受，將於9月舉行的ESMO大會上進行報告。此外，FIGHT研究的最終分析也已完成。 FIGHT研究是一項II期隨機、雙盲、對照試驗，旨在評估貝馬妥珠單抗（一種靶向成纖維細胞生長因子受體2b (FGFR2b) 的單株抗體）聯合改良FOLFOX6方案治療既往未接受過治療的晚期胃癌和胃食道交界處癌患者的療效。這些結果繼續表明，貝馬妥珠單抗聯合改良FOLFOX6方案可改善FGFR2b表達腫瘤患者的臨床結局，且未發現新的安全性問題。 FGFR2b表現量越高，患者的生存獲益越大。

In general medicine, we announced top line data from a Phase II study of Olpasiran, our small interfering RNA targeting Lp(a). These data demonstrated a significant reduction from baseline in Lp(a) of up to or greater than 90% at week 36, the primary endpoint, and week 48, the end of treatment period, for the majority of doses, which range from once every 12 weeks to once every 24 weeks in dosing frequency. No new safety concerns were identified during this treatment period. Presentation of these results is expected at a medical congress in the second half of this year. We're very excited about this innovative molecule and are moving to rapidly initiate a Phase III outcome study.

在一般醫學領域，我們發表了針對 Lp(a) 的小幹擾 RNA 藥物 Olpasiran 的 II 期臨床研究的主要數據。數據顯示，在第 36 週（主要終點）和第 48 週（治療結束），大多數劑量組的 Lp(a) 水準較基線顯著降低，降幅達 90% 或以上。給藥頻率從每 12 週一次到每 24 週一次不等。治療期間未發現新的安全性問題。預計將在今年下半年的醫學會議上公佈這些結果。我們對這項創新分子充滿信心，並正在積極推動 III 期臨床結果研究的啟動。

AMG 133, our multispecific that inhibits the gastric inhibitory polypeptide receptor, GIPR, and activates the glucagon-like peptide 1, GLP-1 receptor, has completed enrollment. We are planning to submit data from the initial cohorts of this Phase I study for medical congress occurring late this year and are actively planning the Phase II program for this molecule.

我們的多標靶抑制劑AMG 133可抑制胃抑制多肽受體（GIPR）並活化胰高血糖素樣勝肽-1受體（GLP-1受體），目前已完成患者招募。我們計劃在今年稍後舉行的醫學大會上提交該I期研究首批隊列的數據，並正在積極籌備該分子的II期臨床試驗項目。

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，我們完全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。

And with that, I'll turn it back to Bob for questions and answers.

接下來，我將把問題和答案交還給鮑伯。

Okay. Thank you, Dave. Jason, could you remind our callers of the process for asking a question?

好的。謝謝你，戴夫。傑森，你能提醒一下來電者提問的流程嗎？

(Operator Instructions) Our first question comes from Jay Olson with Oppenheimer.

（操作說明）我們的第一個問題來自奧本海默公司的傑伊·奧爾森。

Congrats on the ChemoCentryx deal. It looks like a really exciting opportunity to treat patients with high unmet medical need in AAV. Can you just talk about the synergies, in particular, revenue synergies potential and then the strategic fit for ChemoCentryx within your organization?

恭喜您達成與ChemoCentryx的合作協議。這看起來是一個非常令人振奮的機會，可以為AAV患者提供尚未充分滿足的醫療需求。您能否談談此次合作的綜效，特別是收入綜效的潛力，以及ChemoCentryx與貴公司策略的契合度？

Yes. Thanks, Jay. We -- as you can tell, we're excited about the fit. We expect our teams in inflammation and in nephrology will be excited to have this product added inside Amgen. And in terms of synergies, obviously, it's a very good fit, but we're focused on investing and growing this opportunity. We think we see some opportunities to help the team at ChemoCentryx reach even more patients than they have so far. So our focus will be on that. And so I don't think we really have much more to say at this point other than reiterating that we're excited about it. I think it addresses an important need in the marketplace. It makes a big difference for patients who otherwise don't have great alternatives available to them.

是的，謝謝，傑伊。如你所見，我們對這次合作感到非常興奮。我們相信，發炎和腎臟病領域的團隊也會對安進公司新增這款產品感到高興。就協同效應而言，這顯然是一個非常好的契合點，但我們目前專注於投資和擴展這一機會。我們認為，我們有機會幫助ChemoCentryx團隊惠及比以往更多的患者。因此，我們將重點關注這一點。所以，除了重申我們對這項合作感到興奮之外，我想目前我們沒有什麼要補充的了。我認為它滿足了市場上一個重要的需求，對於那些沒有其他有效治療方案的患者來說，它意義重大。

Our next question comes from Chris Raymond with Piper Sandler.

下一個問題來自克里斯·雷蒙德和派珀·桑德勒。

Maybe just on -- also another question maybe digging in to TAVNEOS. And also, if I can touch on, Bob, your comments on the drug pricing legislation as it relates to this deal. So I think you guys pointed out having a nephrology and inflamm presence is kind of unique for you guys on the commercial side. Maybe just give a bit more color how you intend to leverage these 2 forces and the specific roles they'll have.

或許可以再補充一點──另外，關於TAVNEOS，我還有一個問題想深入探討。還有，Bob，如果可以的話，我想問你對藥品定價法規與這筆交易的關係的看法。你們之前提到過，在腎臟病和發炎領域擁有業務對你們的商業運作來說相當獨​​特。能否再詳細說說你​​們打算如何利用這兩方面的優勢，以及它們將扮演的具體角色？

And then maybe the second part, this drug pricing language, there's a decent amount of angst, specifically around provisions, targeting small molecules and allowing CMS to negotiate in year 9. So ChemoCentryx is predominantly a small molecule company. Just maybe square those 2 issues there, if you will.

然後，關於藥品定價條款，也就是第二部分，可能存在不少爭議，特別是針對小分子藥物的條款，以及允許CMS在第九年進行談判的條款。 ChemoCentryx主要是一家小分子藥物公司。或許可以把這兩個問題在這裡統一一下。

Sure. Murdo, why don't you start on the first question?

當然可以。默多，你先回答第一個問題吧？

Yes. Thanks for the question, Chris. We are obviously pleased with the very nice strategic fit of TAVNEOS in our portfolio. The ChemoCentryx team have been mostly focused on rheumatology, and there are subspecialties of rheumatologists who treat a lot of these AAV patients. So they've been quite focused in their commercial efforts so far. We can scale that much more broadly. We have a national footprint on rheumatology given our current in-line inflammation business. And we can also add nephrology. About 1/3 of these patients end up getting diagnosed by nephrologists given that one of the presentations of AAV is renal impairment or renal inflammation, I should say. So that's the immediate benefit.

是的，謝謝你的提問，克里斯。我們非常高興TAVNEOS能夠如此完美地融入我們的產品組合。 ChemoCentryx團隊一直專注於風濕病領域，而風濕病專家中有很多次專科醫生專門治療AAV患者。因此，他們迄今為止的商業推廣工作都非常集中。我們可以將業務拓展到更廣泛的領域。鑑於我們目前在售的發炎治療產品，我們在風濕病領域已經擁有全國性的業務佈局。此外，我們還可以拓展到腎臟病領域。大約三分之一的AAV患者最終是由腎臟科醫生確診的，因為AAV的臨床表現之一是腎功能損傷或腎臟發炎。這就是我們目前能夠獲得的直接益處。

But we've also got resources like our patient support programming, our medical teams, our institutional key account managers, our ability to work with payers to ensure that the medical policies and prior authorizations are seamless for providers and patients. So there's a lot we can bring to the table beyond just a very focused but very effective so far ChemoCentryx effort.

但我們也擁有其他資源，例如病患支援計畫、醫療團隊、機構重點客戶經理，以及與支付方合作的能力，以確保醫療政策和預先授權流程對醫護人員和病患來說都順暢無阻。因此，除了目前為止非常有效且目標明確的ChemoCentryx專案之外，我們還能提供許多其他方面的協助。

And with respect to Washington, Chris, obviously, we evaluated this in the context of the legislation, the potential legislation that's making its way through the Senate at the moment. And while as you point out, this is a small molecule product, we don't expect that there's any particular risk for this product as compared to other small molecules that could become subject to the price controls implied or implicit in the legislation. So again, we think this is an attractive product. The clinical profile looks really well suited to the needs of the marketplace, and we're excited to be joining the team with them.

至於華盛頓方面，克里斯，顯然，我們是在相關立法背景下評估的，特別是目前正在參議院審議的潛在立法。正如你所指出的，這是一款小分子產品，但我們認為，與其他可能受到立法中隱含或明示的價格管制的小分子藥物相比，這款產品並沒有什麼特別的風險。所以，我們再次強調，我們認為這是一款很有吸引力的產品。其臨床特性似乎非常符合市場需求，我們很高興能加入他們的團隊。

Our next question comes from Salveen Richter with Goldman Sachs.

下一個問題來自高盛的薩爾文·里希特。

Maybe just a follow-up here. I'd love to dig a little deeper into what you said in the prepared remarks about the passage of this legislation accelerating trends to reposition the business and manage life cycles. Do you think this increases the urgency for M&A given your financial strength? And if so, what types of targets probably would make sense given the debate about non-orphan products versus orphan products? And just a second question here on AMJEVITA, being first to market, maybe you could just give us a sense of how that positions you and early payer discussions here?

這裡還有一個後續問題。我很想更深入地探討一下您在準備好的演講稿中提到的，這項立法的通過加速了業務重組和生命週期管理的趨勢。鑑於貴公司的財務實力，您認為這是否會增加併購的迫切性？如果是這樣，考慮到目前關於非孤兒藥和孤兒藥的爭論，哪些類型的收購目標可能比較合適？另外，關於AMJEVITA，作為首家上市的公司，您能否談談這在貴公司和早期支付方的討論中處於什麼地位？

Yes, you're going to catch the second piece of that, Murdo? And I'll address the first, which is with respect to Washington, again, Salveen, as you know, this is still a potential legislation. So we'll watch carefully to see if it gets passed and, if it does, exactly what gets passed. So I don't think at this point, we'll say anything more specific than what I said in my opening remarks, which is that we've been advocating for reform that would promote innovation and improve patient access to it, and we'll be concerned to the extent that the legislation that passes doesn't do those 2 things.

是的，你會注意到第二點嗎，默多？我先來說說第一點，關於華盛頓的情況。薩爾文，你也知道，這仍然是一項潛在的立法。所以我們會密切注意它是否能夠通過，如果通過，具體內容又是什麼。因此，我認為目前我們不會透露比我開場白中所說的更具體的訊息，那就是我們一直倡導改革，以促進創新並改善患者獲得治療的機會。如果最終通過的法案未能實現這兩點，我們會感到擔憂。

And Salveen, on AMJEVITA, obviously, we're pleased that we're first out of the gate with the AMJEVITA launch in the U.S. at the end of January next year. We were pleased with our performance outside the U.S. with AMGEVITA where we've established market leadership with the high share, and we've been able to hold that despite competition. Obviously, the U.S. market is a different market given payer and reimbursement structure, but we feel confident that we'll be able to establish good access and coverage for AMJEVITA early in the launch life cycle. And we think that PBMs and payers are interested in ensuring that their patients and members have biosimilar availability and options. So all going well and according to plan. Thanks.

薩爾文，關於AMJEVITA，我們當然很高興能在美國率先推出，時間定於明年1月底。我們對AMJEVITA在美國以外市場的表現感到滿意，我們憑藉高市佔率確立了市場領導地位，儘管面臨競爭，我們仍然保持了這一優勢。顯然，鑑於支付方和報銷結構，美國市場與其他國家/地區有所不同，但我們相信能夠在AMJEVITA上市初期就為其建立良好的市場准入和覆蓋範圍。我們認為，藥品福利管理機構（PBM）和支付方都希望確保他們的患者和會員能夠獲得生物相似藥的供應和選擇。所以，一切進展順利，都在照計畫進行。謝謝。

Our next question comes from Umer Raffat with Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Umer Raffat。

I'll ask 2 today, if I may. One on your deal and one on the quarter. Maybe starting with the quarterly update. I saw your partner as well as your press release talked about the safety issue in the -- sorry, talked about the lack of safety issue on the OX40 program, however, the need to perhaps change the dosing regimen. I guess my question is, if there's no safety issue, is it fair to assume there's a biomarker change, maybe a severe TH drop in the subset of patients, which could be prompting this regulatory feedback? And if you could remind us what dose were you currently using every 2 weeks in Phase III?

今天想問兩個問題，可以嗎？一個是關於你們的交易，一個是關於季度報告的。或許可以先從季度報告開始。我看到你們的合作夥伴以及你們的新聞稿都提到了OX40項目的安全性問題——抱歉，是提到了該項目不存在安全性問題，但提到可能需要調整給藥方案。我想問的是，如果沒有安全性問題，是否可以合理地假設存在生物標記變化，例如部分患者的甲狀腺激素（TH）水平嚴重下降，從而引發了監管機構的回饋？另外，能否提醒一下，在三期臨床試驗中，你們目前每兩週使用的劑量是多少？

And then on ChemoCentryx deal, I think it's an interesting case study on sort of where the clinical data stood versus how good the commercial receptivity has been. But is it fair to assume that you wouldn't have moved forward with the deal unless they were already at perhaps 700-plus patients by now and their peak patient guidance was 6,000?

至於ChemoCentryx的交易，我認為這是一個有趣的案例研究，它展現了臨床數據與商業接受度之間的關係。但如果他們現在還沒有700多名患者，而他們的患者峰值預期是6000人，那麼我們是否可以合理地假設你們不會推進這筆交易呢？

Okay. Dave, do you want to take the first?

好的。戴夫，你想先開第一局嗎？

Yes. So -- yes, thanks, Umer. In regards to OX40, yes, no safety issue, no biomarker issue either, no change in any kind of patient subset. As I said in my prepared remarks beginning -- this is really driven by ongoing discussions with the FDA to explore broader range of doses, and we took that opportunity to, we think, improve patient convenience. I wouldn't overthink it or read anything more into it than that. And we don't think that this will affect overall program time lines.

是的。所以——是的，謝謝你，Umer。關於OX40，是的，沒有安全問題，也沒有生物標記問題，對任何患者群體都沒有影響。正如我在準備好的發言稿開頭所說——這實際上是基於我們與FDA正在進行的討論，旨在探索更廣泛的劑量範圍，我們藉此機會，我們認為可以提高患者的用藥便利性。我不會過度解讀或做任何其他解讀。而且我們認為這不會影響整個專案的進度。

Yes. And, Umer, I'm not exactly sure what you're looking for in your specific question. But Murdo, go ahead and feel free to jump in.

是的。還有，烏默，我不太確定你具體想問什麼。不過默多，請儘管插話吧。

Yes. Umer, we've been following the TAVNEOS journey for a while. And I think what everybody has to remember here is the nature of this disease. I mean this is a severe acute autoimmune inflammation that involves the lungs, the kidneys and sometimes skin and other organs and can cause permanent end organ damage, if not treated effectively and efficiently and quickly. And the current standards of care are difficult treatments for patients to tolerate. And if you can intervene and improve that patient's potential to remain relapse-free over the first 52 weeks, as a rheumatologist or a nephrologist, if you -- all you have to do is add TAVNEOS to their base regimen, you're going to do that. So I think the behavioral change here is one that many physicians are choosing to do. And that, as you alluded to, has been encouraging to see in the early phase of this launch.

是的，Umer，我們一直在關注TAVNEOS的進展。我認為大家必須記住這種疾病的本質。這是一種嚴重的急性自體免疫炎症，會涉及肺、腎，有時還會涉及皮膚和其他器官，如果不及時有效治療，可能會造成永久性終末器官損傷。目前的標準治療方案對患者來說耐受性很差。如果你作為風濕病學家或腎臟科醫生，能夠幹預並提高患者在最初52週內保持無復發狀態的可能性，那麼你只需將TAVNEOS添加到他們的基礎治療方案中，你就會這麼做。所以我認為，許多醫生正在選擇改變這種治療方案。正如你所提到的，在TAVNEOS上市初期，看到這樣的結果令人鼓舞。

But the reason we like TAVNEOS is it helps reduce the potential relapse for patients by adding TAVNEOS to the current standard of care and potentially reducing glucocorticoid use. So this is a disease area that, if we were doing the development on our own, it would fit squarely in our strategy. And so it comes into a strong inflammation portfolio, and it's one that we think our scale and commercial and medical capabilities will allow us to accelerate what has already been a good launch.

但我們看好TAVNEOS的原因在於，它透過將TAVNEOS加入現有標準治療方案，並有可能減少糖皮質激素的使用，從而幫助降低患者復發的可能性。因此，如果我們獨立進行研發，這個疾病領域的藥物將完全符合我們的策略。它豐富了我們強大的發炎產品組合，我們相信憑藉我們的規模、商業和醫療能力，能夠加速推進這款已經取得良好上市成果的產品。

And I'd say, Umer, that we're obviously attractive in the fact that it's still in an early stage of its launch, and we think we can add value to that, and the feedback from the marketplace has been encouraging. The prescriber and patient-based marketplace that is.

烏默爾，我想說，我們顯然很有吸引力，因為它仍處於早期推廣階段，我們認為我們可以為其增添價值，而且來自市場的反饋也令人鼓舞。這裡指的是以處方醫生和病人為中心的市場。

The next question comes from Michael Yee with Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

Maybe for David. I know the upcoming data, you talked about a challenge in combination with PD-1. So maybe you could just right size your expectations. Is the bar fairly high there to move forward due to tox? And is your focus on frontline really in the combination with chemo? So maybe just make a comment there.

或許對大衛來說是這樣。我知道即將公佈的數據，你之前也提到與PD-1合併用藥的挑戰。所以，或許你可以調整一下預期。由於毒性，推進該療法的門檻是否很高？你一線治療的重點真的是與化療合併嗎？所以，或許你可以就此發表一下看法。

And if you could just sneak in a second one. You actually talked about AMG 133 on your slide deck. I know there's a lot of focus, obviously, on obesity. Can you just comment on what we're supposed to know there to be advancing that forward?

如果您能再補充一點就更好了。您在幻燈片裡提到了AMG 133。我知道現在大家都很關注肥胖問題。您能否談談我們應該了解哪些面向才能推動這個議題的發展？

Yes, sure. So in terms of the LUMAKRAS/PD-1 combination, obviously, I can't say much because of the embargo. We're presenting these data Sunday afternoon in Vienna. As you -- as we think about development in first line, I like to think of kind of 3 buckets of patients, those whose tumors are PD-L1 negative, those who are PD-L1 low to intermediate and those that are PD-L1 high expressers. As I mentioned and as you picked up on in the PD-L1 negative population, we're moving forward with a LUMAKRAS plus chemotherapy Phase III trial. And then we will disclose the results of the checkpoint inhibitor data in Vienna and outline our plans for further development in this space. I think that's probably all I can say right now. But I would really think about this as different groups of patients where the therapy will be tailored to their particular tumor based on PD-L1 expression.

是的，當然。關於LUMAKRAS/PD-1聯合療法，由於保密協議的限制，我目前無法透露太多資訊。我們將在周日下午於維也納公佈這些數據。如您所說，在考慮第一線治療方案的研發時，我傾向於將患者分為三類：PD-L1陰性腫瘤患者、PD-L1低表達至中表達腫瘤患者以及PD-L1高表達腫瘤患者。正如我之前提到的，也正如您所注意到的，在PD-L1陰性患者群體中，我們正在推進LUMAKRAS聯合化療的III期臨床試驗。之後，我們將在維也納公佈免疫檢查點抑制劑的數據，並概述我們在該領域的後續研發計畫。我想目前我只能透露這麼多。但我認為，應該將患者分為不同的群體，並根據PD-L1表達水平為他們量身定制治療方案。

And on AMG 133, yes, very pleased with our progress there. As I mentioned, we completed enrollment in the Phase I. We hope to present that. We're submitting -- in the process of submitting that to a medical congress. And we're very actively planning what the Phase II program will look like, and we'll have more to say about that as our plans are finalized over the coming months.

關於AMG 133，是的，我們對目前的進展非常滿意。正如我之前提到的，我們已經完成了I期臨床試驗的受試者招募。我們希望能夠展示相關結果。我們正在向醫學大會提交申請。同時，我們也積極規劃II期臨床試驗方案，隨著未來幾個月方案的最終確定，我們將公佈更多資訊。

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。

Great. Bob, if I could just ask your sort of outlook on BD and M&A. We see you do 2 modestly sized deals for assets with a bit of a pipeline over the course of the last year. How do you think about continuing to do more deals of that size versus something larger and more transformational? And just how do you think about where you are in terms of adding assets versus where you'd like to be?

好的。鮑勃，請問您對業務拓展和併購有什麼看法？我們看到您在過去一年完成了兩筆規模適中的交易，並收購了一些有一定儲備的項目。您如何看待繼續進行這類規模的交易，還是會考慮規模更大、更具變革性的項目？您如何看待目前在資產收購方面的位置，以及您希望達到的目標？

Matt, I don't think anything has changed. We continue to look for ways to invest in the business. And our focus is on trying to find the best innovation and to try to advance that particularly in the areas where we've been clear about our stated interest, so inflamm, oncology and in the general medicine area. So we continue to look. There are obviously many more opportunities in the small and medium size than there are in the large size. But we, as I've said consistently through my tenure, Matt, we feel responsibility to look at all the options to add value for our shareholders, and we'll continue to do that.

馬特，我認為情況沒有改變。我們一直在尋找投資公司業務的途徑。我們的重點是尋找最佳創新，並努力推動這些創新，尤其是在我們明確表示感興趣的領域，例如發炎、腫瘤和普通醫學領域。所以我們會繼續尋找機會。顯然，中小企業比大型企業擁有更多機會。但是，正如我在任期間一直強調的，馬特，我們有責任考慮所有能夠為股東創造價值的方案，我們將繼續這樣做。

Our next question comes from David Risinger with SVB Securities.

下一個問題來自SVB證券的David Risinger。

So my question is related to understanding interchangeable biosimilars. And there are 2 parts, please. So first, obviously, AMJEVITA is in a great position in the first half of next year. But could you talk about that product's ability to compete with interchangeable biosimilars that are launching in the second half of '23 since AMJEVITA won't have that designation?

我的問題與理解可互換生物相似藥有關。問題分為兩部分。首先，很顯然，AMJEVITA 在明年上半年處於非常有利的地位。但是，由於 AMJEVITA 屆時還沒有獲得可互換生物相似藥的認證，您能否談談該產品與 2023 年下半年上市的其他可互換生物類似藥的競爭能力？

And then the other part is news just hit a couple of days ago that the FDA-approved biosimilar Lucentis as interchangeable even though there was never a switching study conducted. So I'm wondering if that's a sign that your ABP 938 or biosimilar EYLEA is likely to also be approved as an interchangeable?

另一方面，幾天前剛有消息稱，FDA批准了生物相似藥Lucentis作為可互換藥物，儘管從未進行過轉換研究。所以我想知道，這是否意味著您的ABP 938或生物相似藥EYLEA也可能被批准為可互換藥物？

Thanks, David, for the question. I would say right now that in our conversations with payers and insurers and, for that matter, physicians, interchangeability has not been a barrier to have them consider AMGEVITA as an option and an alternative to the innovator. We are pursuing interchangeability with AMGEVITA, and we'll expect those data to read out later on in the launch. So I think our incumbent position being first to launch will help weather additional competition as they enter if they have interchangeability. And our expectation is at least a couple will. But we'll follow quickly with our own interchangeability data. So it will be a short period in time where that competitive advantage may exist or persist in the market. As for ABP 938, I won't speculate on what the FDA might say about that. Thank you.

謝謝David的提問。我想說的是，在我們與支付方、保險公司以及醫生的溝通中，互換性並沒有成為他們將AMGEVITA視為創新藥物替代方案的障礙。我們正努力實現AMGEVITA的互換性，預計相關數據將在產品上市後公佈。因此，我認為我們作為首批上市的供應商，其優勢將有助於我們抵禦其他競爭對手的挑戰，前提是他們也具備互換性。我們預計至少會有幾家競爭對手具備互換性。但我們會迅速公佈我們自身的互換性數據。因此，這種競爭優勢在市場上存在或持續的時間可能很短。至於ABP 938，我不會對FDA的表態妄加猜測。謝謝。

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。

And maybe a question on LUMAKRAS Phase III study. So Dave, what do you think could be clinically meaningful benefit over docetaxel in this particular study? And the other question, the other part of the question is basically, if you think about chemo post IO, chemo tends to do well. Do you think placebo response could be better than historical in this particular trial?

還有一個關於LUMAKRAS III期研究的問題。 Dave，你認為在這項研究中，與多西他賽相比，LUMAKRAS可能有哪些具有臨床意義的優勢？另一個問題是，如果你考慮免疫療法後的化療，化療通常效果不錯。你認為在這項試驗中，安慰劑效應會優於歷史數據嗎？

So yes, in terms of the Phase III study, it's on track to report out this quarter. It's an event-driven trial. If we see behavior of LUMAKRAS consistent with what we've observed really across the program to date in advanced lung cancer, I think we'll be well positioned there. The trial has 90% power to detect a significant difference in progression-free survival. So it's very well powered. I'm sure it will be a well-conducted study. And so we look forward to having those data soon.

是的，就III期研究而言，它正按計劃進行，預計將於本季公佈結果。這是一項事件驅動型試驗。如果我們觀察到LUMAKRAS在晚期肺癌患者中的表現與我們迄今為止在整個計畫中觀察到的結果一致，我認為我們將處於有利地位。該試驗有90%的把握度來檢測無惡化存活期的顯著差異。因此，它的統計效力非常高。我相信這將是一項高品質的研究。我們期待盡快獲得這些數據。

In terms of the placebo response, that -- I think it's hard to speculate on that. The trial that we are conducting in the PD-L1 negative is chemotherapy plus LUMAKRAS against what would be considered a standard therapy arm, where the addition of checkpoint inhibitors has a relatively modest additive benefit. So based on preliminary data that we've seen looking at LUMAKRAS in combination with chemotherapy, that's what's given us the confidence to move into Phase III, and we've had productive discussions with regulators about that trial design.

至於安慰劑效應，我覺得很難推測。我們正在PD-L1陰性患者中進行的試驗是化療合併LUMAKRAS治療，並與標準治療組進行比較。在標準治療組中，添加免疫檢查點抑制劑的額外益處相對較小。基於我們目前觀察到的LUMAKRAS聯合化療的初步數據，我們有信心推進到III期臨床試驗，並且我們已就該試驗設計與監管機構進行了富有成效的討論。

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

下一個問題來自美國銀行的傑夫‧米查姆。

I had one on LUMAKRAS, I guess, Murdo, for you commercially. When you look at the U.S. trends over the past, say, 3 quarters or so, maybe just help us with kind of are you reaching peak sort of saturation for G12C testing. How do you think about that in terms of the timing of getting to that same level outside the U.S.? And then maybe a lot of people have asked about kind of the Phase III combo studies that maybe if there is at a high level kind of an incremental opportunity that you would envision as you look to the combination study data.

我之前問過你一個關於LUMAKRAS的問題，Murdo，是關於商業方面的。你觀察一下過去三個季度左右的美國市場趨勢，能不能幫我們分析一下G12C檢測是否已經達到飽和？你認為美國以外地區何時才能達到同樣的水準？還有，很多人可能問過關於III期聯合療法研究的問題，你認為從聯合療法研究的數據來看，是否有潛在的成長機會？

Yes. Thanks for the question, Geoff. I would say it's less about peak testing in the U.S., where we've already got about 85% of frontline patients being tested and receiving a KRAS G12C status. Right now, what we know is only half of the tested patient population in second line has the test result available when they're progressing. So that's really what we're focused on. We're focused on where is that test result for that progressing patients so that treating oncologist can give the patient the benefit of LUMAKRAS. And when they have that test is, again, half the time, 85% of those patients get LUMAKRAS. So we're getting a very high percentage penetration of those second-line patients when the prescribing physician knows their test result. So we are not peaking yet. We've got headroom for more improvement there. Currently, about half of those patients are not getting their KRAS G12C test result reviewed upon progression. So that's an important thing that teams are focused on. That's what we think we can do to continue to drive some revenue growth in the U.S.

是的，謝謝你的提問，Geoff。我認為目前的問題不在於美國的檢測率是否達到峰值，因為目前已有大約85%的第一線患者接受了檢測並獲得了KRAS G12C狀態。我們現在知道的是，在二線治療的患者中，只有一半在病情進展時能夠獲得檢測結果。所以，這才是我們真正關注的重點。我們關注的是如何讓病情進展的患者盡快獲得檢測結果，以便主治腫瘤醫師能夠讓患者受益於LUMAKRAS化療。而當患者獲得檢測結果後，約有85%的患者最終接受了LUMAKRAS化療。因此，當處方醫生了解患者的檢測結果時，二線治療患者的覆蓋率非常高。所以我們還沒有達到峰值，還有很大的提升空間。目前，大約有一半的患者在病情進展後沒有獲得KRAS G12C檢測結果的複查。這也是團隊正在努力解決的重要問題。我們認為，透過這種方式，我們可以繼續推動美國市場的收入成長。

Now outside the U.S., what we're seeing is really, again, a tale of 2 types of markets. In markets like Germany, Switzerland and France, where biomarker testing is very well developed and their clinical information systems are also very well developed so that, that test is available and retrievable upon progression in second line, we're seeing very rapid lift and uptake. In places where that's not quite as well developed, think Spain, Italy, to some extent, the U.K., the uptake resembles more what we've seen in the U.S. So...

現在，在美國以外，我們看到的市場情況其實又分為兩種。在德國、瑞士和法國等市場，生物標記檢測技術非常成熟，臨床資訊系統也十分完善，因此，在二線治療進展時，檢測結果可以隨時取得和檢索，我們看到檢測的普及率和應用速度都非常快。而在生物標記檢測技術發展相對落後的地區，例如西班牙、義大利，以及在某種程度上還有英國，其應用情況更類似美國的情況。所以…

And just to clarify, this is in our expanded access programs.

需要澄清的是，這是我們擴大准入計畫的一部分。

Yes. In our expanded access programs where we've seen clinical utilization, but I'm also talking about other experience with other targeted therapies. You're going to see a slower uptake in some markets than you will and others because of that testing infrastructure. So we're working on that with those markets. We're changing that behavior with clinicians. And I think we'll be able to successfully grow this product in second line. And then, of course, if we get confirmatory data in Phase III, what that does is it makes it easier to promote because we're no longer on an accelerated approval. And hopefully, the data set are compelling and continue to reinforce the value of LUMAKRAS.

是的。在我們擴大用藥計畫中，我們已經看到了臨床應用，但我也想談談其他標靶療法的經驗。由於檢測基礎設施的限制，某些市場的接受度會比其他市場低。所以我們正在與這些市場合作，努力改變臨床醫師的用藥習慣。我認為我們能夠成功地將該產品推廣到二線治療領域。當然，如果我們在三期臨床試驗中獲得確證性數據，這將使我們更容易推廣該產品，因為我們不再處於加速審批階段。希望這些數據能令人信服，並持續鞏固LUMAKRAS的價值。

The next question comes from Yaron Werber with Cowen.

下一個問題來自 Cowen 公司的 Yaron Werber。

Great. David, it's for you. With respect to TAVNEOS, the drug was tested in C3 glomerulopathy and also severe HS, in ACCOLADE and AURORA. And that data was a bit mixed. I think they were looking for FDA feedback on C3G, and they're thinking about lupus nephritis as well, potentially starting another study. Any thoughts of that --are these indications that you are supportive of?

太好了，David，這是給你的。關於TAVNEOS，這款藥物在ACCOLADE和AURORA研究中針對C3腎絲球病變和重度化膿性汗腺炎進行了測試。但數據有點喜憂參半。我想他們當時正在尋求FDA對C3腎絲球病的回饋，而且他們也在考慮狼瘡性腎炎，可能還會啟動另一項研究。你對此有什麼看法？你支持這些適應症嗎？

Yes. Thanks, Yaron. Yes. So there are other disorders, as you're indicating, in which TAVNEOS has been investigated where activation of this limb of the complement cascade may play a role in the inflammatory disease process such as C3 glomerulopathy and hidradenitis suppurativa. We'll look at all of those data, look at the programs with our new colleagues from ChemoCentryx and determine what the best path forward is to potentially address, again, diseases where there's currently very little effective therapy.

是的，謝謝，亞倫。是的。正如您所指出的，TAVNEOS 也已被用於研究其他一些疾病，在這些疾病中，補體級聯反應的這一環節的激活可能在炎症性疾病過程中發揮作用，例如 C3 腎小球病和化膿性汗腺炎。我們將研究所有這些數據，並與來自 ChemoCentryx 的新同事一起研究相關項目，以確定最佳的前進方向，從而有可能解決目前幾乎沒有有效療法的疾病。

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。

Great. So I wanted to come to your heme/onc franchise. You still have BLINCYTO and KYPROLIS, but we saw the discontinuation of the latest kind of BiTE you had in myeloma. Amgen had a multiyear effort to try to extend its myeloma franchise. Is that still -- where does that rank in terms of priorities? And I guess, just speaking more broadly, what does this say about the sort of the innovation jumps required to compete in heme/onc going forward?

好的。所以我想談談你們的血液腫瘤產品線。你們目前還有BLINCYTO和KYPROLIS，但我們注意到你們在多發性骨髓瘤領域最新推出的BiTE藥物已經停產。安進曾投入多年精力試圖拓展其多發性骨髓瘤產品線。目前這項計劃還在進行中嗎？它在你們的優先事項中處於什麼位置？另外，更廣泛地說，這說明未來在血液腫瘤領域保持競爭力需要怎樣的創新飛躍？

We can take this in 2 parts. I think, with respect to KYPROLIS, obviously, we're encouraged by the ongoing performance of that. And more generally, the heme/onc portfolio, as you referred to, you talk about ongoing success of BLINCYTO. Again, we're very encouraged by what we see and what we think we can continue to do for patients in relapsed/refractory ALL. But I think you also raised the important point, which is that multiple myeloma is a very crowded space. And our decision with respect to 701 had a lot to do with our ability to get to market ahead of the competition or not. So we're prioritizing on those medicines where we think we can be best in class and first in class. And we have other programs underway that may be useful in multiple myeloma. And Dave, why don't you jump in.

我們可以分成兩部分來討論。首先，關於KYPROLIS，顯然，我們對它目前的良好表現感到鼓舞。其次，正如您所提到的血液腫瘤產品組合，您也提到了BLINCYTO的持續成功。我們對目前所看到的以及我們認為能夠繼續為復發/難治性ALL患者帶來的益處感到非常振奮。但您也提出了一個重要的觀點，那就是多發性骨髓瘤領域競爭非常激烈。我們關於701的決定很大程度上取決於我們能否搶在競爭對手之前將產品推向市場。因此，我們優先研發那些我們認為能夠成為同類最佳或同類首創的藥物。此外，我們還有其他一些正在進行的項目，這些項目可能對多發性骨髓瘤有效。 Dave，您不妨也說說您的看法。

Yes. So as an area, look, we're guided by the science and the biology that we uncover. AMG 701, that was a strategic decision of multiple agents targeting BCMA. And we chose to focus our efforts on, for example, tarlatamab, the DLL3 program, where we've got a substantial lead. We've got a molecule that's extremely active. Same platform is AMG 701, and so I think you'll see this kind of prioritization going forward.

是的。所以，作為一個領域，我們始終以所發現的科學和生物學為指導。 AMG 701 的研發是一個策略決策，當時我們考慮了多種針對 BCMA 的藥物。我們選擇將精力集中在例如 tarlatamab 和 DLL3 專案上，因為我們在這個專案中擁有顯著的領先優勢。我們已經研發出一種活性極高的分子。 AMG 701 也採用了相同的平台，所以我認為未來你會看到類似的優先順序。

Our next question comes from Evan Seigerman with BMO.

我們的下一個問題來自 BMO 的 Evan Seigerman。

Congrats on the deal earlier today. I actually want to touch on your prostate cancer efforts. Can you just walk me through some of the details around you deprioritizing 160 for the lower affinity T-cell BiTE? And just given the recent data we've seen in this space with maybe newer technologies, bispecific targeting CD28 and PSMA, how do you think your efforts can remain competitive here?

恭喜您今天早些時候達成的交易。我想談談您在前列腺癌領域的研究進展。您能否詳細解釋一下，為什麼您放棄了160號靶點，轉而研發親和力較低的T細胞雙特異性抗體（BiTE）？鑑於我們最近在這個領域看到的數據，以及一些可能更新的技術，例如靶向CD28和PSMA的雙特異性抗體，您認為您的研究如何保持競爭力？

Yes. Thanks for the question. So we've got now a pair of molecules targeting prostate cancer, actually 3, if you include neuroendocrine prostate cancer where we're conducting a tarlatamab study where DLL3 expression is quite frequent in neuroendocrine tumors. But first, AMG 509 targeting STP1 continue to be impressed with the data we're generating in that trial, and we are moving ahead with all deliberate speed to advance that program. We hope to be able to share data either late this year or sometime into next year from that dose escalation in first-in-human study.

是的，謝謝你的提問。目前我們有兩款針對攝護腺癌的分子藥物，如果算上神經內分泌性攝護腺癌，其實是三款。我們正在進行一項tarlatamab的研究，DLL3在神經內分泌腫瘤中表達相當普遍。但首先，AMG 509靶向STP1，我們對試驗中獲得的數據感到非常滿意，並以最快的速度推進該計畫。我們希望能在今年稍後或明年某個時候分享首次人體試驗劑量遞增階段的數據。

And then as we -- as I had indicated all along, we would take a look at the accumulating data from AMG 160, Acapatamab and AMG 340, which came to us through the TeneoBio acquisition. And based on what we saw, we elected to prioritize AMG 340 targeting PSMA going forward. The data you're alluding to from a few days ago is a handful of patients. We've seen similar things in early phases. I think what you need is more patients and, in particular, prolonged follow-up, especially in this disease. And in that regard, I'm quite encouraged with what I'm seeing from AMG 509, for example. So that portfolio of 3 medicines is advancing. I feel actually very optimistic about what we may be able to do in prostate cancer.

正如我之前一直提到的，我們會仔細研究AMG 160、Acapatamab和AMG 340的累積數據，這些藥物是透過收購TeneoBio獲得的。根據我們觀察到的情況，我們決定優先研發標靶PSMA的AMG 340。您幾天前提到的數據僅來自少數患者。我們在早期階段也觀察到了類似的情況。我認為我們需要更多患者，尤其是需要更長時間的隨訪，尤其是在這種疾病領域。在這方面，例如，我對AMG 509的進展感到非常鼓舞。因此，這三種藥物的研發組合正在穩步推進。我對我們在前列腺癌領域可能取得的成就感到非常樂觀。

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。

I had one on Aimovig. Just wondering if you could comment on market dynamics here, just given the 11% volume decline. Is that a function of competitive dynamics? Or does it have to do with pricing? And how should we think about peak potential given those trends?

我之前在Aimovig投了一票。鑑於銷量下降了11%，我想請您談談目前的市場動態。這是競爭格局變化的結果嗎？還是定價策略的問題？考慮到這些趨勢，我們應該如何看待其峰值潛力？

Yes. Thanks for the question, Michael. I think our focus on Aimovig has been one where we're making sure that we address the patient population, the prevention patient population in a way in which we provide good access but at a reasonable net price. And I think, strategically, we've been able to do that well. We did lose 1 major PBM to the -- at the end of last year into this year, and that's affected the volume evolution. But we've also been able to improve our net pricing year-on-year. So from a profitability standpoint, Aimovig is doing better. And I think longer term, it's early in the marketplace. CGRP class should be growing faster than it is given that the antibodies are much, much better than what's available in the market and the older non-CGRP class. And of course, we've got the advent of the orals. So it's early days. We're still watching it play out. We continue to focus on promoting for the preventive patients that have high-frequency migraine, and we continue to do well there. So longer term, I think there's just a lot to wait and see.

是的，謝謝你的提問，Michael。我認為我們對Aimovig的關注點在於，確保我們能夠以合理的淨價，為預防性患者群體提供良好的用藥途徑。我認為，從戰略角度來看，我們在這方面做得很好。去年年底到今年年初，我們失去了一家主要的藥品福利管理機構（PBM），這影響了銷售成長。但我們也實現了淨價的逐年提升。因此，從獲利角度來看，Aimovig的表現較好。我認為從長遠來看，它還處於市場早期階段。鑑於抗體藥物比市面上現有的藥物以及較老的非CGRP類藥物好得多，CGRP類藥物的成長速度應該更快。當然，口服藥物的出現也帶來了新的機會。所以現在還處於早期階段，我們仍在密切關注市場發展。我們將繼續專注於推廣針對高頻偏頭痛患者的預防性治療，並且我們在這方面也取得了不錯的成績。所以從長遠來看，我認為還有很多事情需要拭目以待。

Our next question comes from Robyn Karnauskas with Truist.

下一個問題來自 Truist 的 Robyn Karnauskas。

I Just had 1 question on Otezla and a follow-up question on the BiTE platform. So for Otezla, just talk a little bit about, given the lower price topicals and some of the data, new drugs that are going to be approved in September, I mean, your thoughts on pricing and how we should think about that over the next year or 2 because I know you need more volume on those new drugs, but they could put some pricing pressure.

我剛才有一個關於Otezla的問題，還有一個關於BiTE平台的後續問題。關於Otezla，鑑於其價格較低的外用製劑以及一些數據，還有即將於9月獲批的新藥，您能否談談定價方面的看法？未來一兩年我們該如何思考定價問題？我知道你們需要這些新藥的銷售量，但它們可能會給價格帶來一些壓力。

And then on the BiTE platform in general, just to follow-up to Evan's question, I mean, so at what point do you -- seeing the new bispec data coming out across the board from other companies at the Co-stim from Regeneron as well, like at what point you deprioritize BiTE versus, say, the new bispec that are out there and put the money toward other things?

然後，關於 BiTE 平台，我只是想接著 Evan 的問題問一句，我的意思是，當看到其他公司（包括 Regeneron 的 Co-stim）也發布了新的 bispec 數據時，你會在什麼情況下降低 BiTE 的優先級，轉而將資金投入到其他方面？

So thanks for the question, Robyn. I'll start with the Otezla question on how the topical entry into the market is affecting our business. I think, overall, we've been really pleased with the expansion of our own label to include the mild patient population. And what I'm encouraged by is in our conversations with payers and PBMs, we were able to have that label expansion, include those patients in our current contracted coverage without adding any value to our deals with the payers. So we didn't have to increase our rebate rate to have the mild patient population included. And in fact, what we've seen is more and more PBMs and plans are removing prior authorization requests for Otezla. So overall, I'd say our access is improving quite a bit without a deterioration in the rates having to pay for it. Where I think you'll see continued price pressure, net price pressure, is in our co-pay assistance that we provide to patients in affordability. That's really what we see as a dynamic on the net price of Otezla in the U.S.

謝謝你的提問，Robyn。我先回答關於Otezla的問題，即局部用藥進入市場對我們業務的影響。總的來說，我們對擴大適應症範圍，將輕症患者群體納入其中感到非常滿意。更令人鼓舞的是，在與支付方和藥品福利管理機構（PBM）的溝通中，我們成功地擴大了適應症範圍，將這些患者納入我們現有的合約承保範圍，而無需增加與支付方的任何額外費用。因此，我們無需提高回饋率即可將輕症患者群體納入其中。事實上，我們看到越來越多的PBM和保險計劃正在取消Otezla的預先授權申請。所以總的來說，我認為我們的用藥可及性得到了顯著改善，而支付成本並未增加。我認為持續的價格壓力，也就是淨價格壓力，將體現在我們為病人提供的共同支付援助上，以降低他們的負擔能力。這才是我們認為影響Otezla在美國淨價格的主要因素。

What we're not seeing, though, is pressure on the net price because of the topical entrants. The challenge with the topical entrants is they don't have broad payer coverage yet. And so until that happens, I think Otezla will continue to do well on the access coverage and rate that we pay for it. Longer term, I think it remains to be seen whether these are in direct competition or complementary to the patient types that we treat. If you talk to the dermatologists, patients fall into categories where they don't want to move into a systemic treatment and stay on topicals and those that are willing to try a topical because the body surface area involvement, the location of their psoriasis, many factors come into play. And that's really where we are competing is people who have already decided they want a systemic agent. So I think they're nonoverlapping populations for the most part, and we don't necessarily see the topicals as applying pricing pressure.

然而，我們目前並未看到外用藥物的出現對淨價構成壓力。外用藥物面臨的挑戰在於，它們尚未獲得廣泛的醫療覆蓋範圍。因此，我認為在健保覆蓋率和我們支付的價格方面，Otezla 將繼續保持良好的市場表現。從長遠來看，這些藥物究竟是與我們治療的患者群體構成直接競爭還是互補，還有待觀察。如果你與皮膚科醫生交流，你會發現患者大致可以分為兩類：一類是不願接受系統性治療，堅持使用外用藥物的患者；另一類是願意嘗試外用藥物的患者，因為受累體表面積、銀屑病部位等諸多因素都會影響他們的選擇。而我們真正的競爭對手是那些已經決定使用系統性藥物的患者。因此，我認為這兩類人群在很大程度上是互不重疊的，我們不認為外用藥物會對價格造成壓力。

Dave, do you want to address Evan's question?

戴夫，你想回答艾文的問題嗎？

Yes. Thanks, Robyn. Yes, in regards to the BiTE platform, we've been working for some time on new-generation technologies that will incorporate things like logic gates with multiple targets where either an and gate or an or gate is engineered into the BiTE for activation. The real goal here is to do 2 things: one, try and enhance efficacy; and two, increase the therapeutic window so that you have as little normal tissue targeting as possible from the agent. So first molecules are moving towards the clinic, and we'll have more to say about that as we get ready to launch.

是的，謝謝，Robyn。關於BiTE平台，我們一直在研發新一代技術，它將整合邏輯閘等多標靶元件，在BiTE中設計一個與閘或或閘來實現活化。我們真正的目標是兩點：一是提高療效；二是擴大治療窗口，盡可能減少藥物對正常組織的標靶作用。目前，首批分子正處於臨床試驗階段，我們將在上市前公佈更多資訊。

Okay, Jason. I know we're a little bit past the top of the hour, but we've got a couple of more questions in the queue. So why don't we take a couple more? And then if we don't get to you, Arvind and his team will be around this evening for some time.

好的，傑森。我知道現在已經過了整點，但我們還有幾個問題等著回答。不如我們再問幾個吧？如果沒輪到你，阿文德和他的團隊今晚還會在這裡待一段時間。

Our next question is from Dane Leone with Raymond James.

下一個問題來自 Raymond James 的 Dane Leone。

I just wanted to get at what's obviously a focus of everyone of estimating what the real opportunity for LUMAKRAS is in the U.S. here. Could you maybe just define your understanding of patients that might be eligible for LUMAKRAS that are in the current studies, the current clinical studies or other patients that might be in assistance co-pay or other schemes where they would be on drug, but just not on commercial paid for a drug? I think that would be helpful is, again, obviously, the run rate is well below what the estimates would be and people are just trying to triangulate over time what the peak sales could really be here in the U.S.

我只是想了解大家顯然都很關注的問題，那就是LUMAKRAS在美國的實際市場機會到底有多大。您能否解釋一下您對LUMAKRAS適用族群的理解，包括目前參與臨床試驗的患者，以及其他可能享受醫療補助或透過其他方式獲得藥物治療但並非由商業機構支付的患者？我認為這會很有幫助，因為很明顯，目前的銷售速度遠低於預期，大家都在嘗試透過長期的市場調查來推導出LUMAKRAS在美國的銷售高峰究竟能達到多少。

Yes, Dane, I think I understand your question, but please ask for clarification if I don't address it. The clinical trial [steel] rate, if you will, patients who are not in commercial drug treatment but are enrolled in other clinical trials, is relatively small as a percentage of the total second-line non-small cell lung cancer patients. I'd say less than 10% would be an estimate. It does vary. It goes up and down depending on the clinical activity of other investigational drugs and trials that are happening. As I was answering a question earlier, the major challenge in growing LUMAKRAS in second line is ensuring that the prescribing physician has the KRAS G12C test result available to them when the lung cancer patient is progressing from frontline to second line. That's the gap in the treatment patient journey. And right now, our estimate is that, that happens about 50% of the time, and we are working to increase that. When that does occur when the prescribing physician has the KRAS G12C result, 8.5x out of 10, that patient gets LUMAKRAS. So we know that the profile of the product is conducive to that second-line treatment choice. We just have to make sure we close down the administrative challenges of having that test result and patient in second-line meet at the same time.

是的，Dane，我想我理解你的問題了，但如果我沒回答到，請隨時提問。臨床試驗參與率（或參與其他臨床試驗的患者比例）相對較低，佔二線非小細胞肺癌患者總數的比例很小。我估計不到10%。這個比例會根據其他在研藥物和試驗的臨床活性而波動。正如我之前回答的問題，LUMAKRAS在二線治療中推廣應用的主要挑戰在於，確保處方醫生在肺癌患者從一線治療過渡到二線治療時能夠獲得KRAS G12C檢測結果。這是患者治療過程中的一個缺口。目前，我們估計這種情況發生率約為50%，我們正在努力提高這個比例。當處方醫師獲得KRAS G12C檢測結果時，十有八九（8.5%）的患者會接受LUMAKRAS治療。因此，我們知道該產品的特性適合作為二線治療方案。我們只需確保解決檢測結果與患者接受二線治療同時出現的行政難題即可。

We're also driving awareness and usage of our liquid biopsy for retesting and reassessment of that patient as they progress to second line. I hope that answers your question.

我們也積極推廣液體切片技術，以便在患者接受二線治療時進行複檢和重新評估。希望這能解答您的疑問。

Our next question comes from Tim Anderson with Wolfe Research.

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

Can I go back to AMJEVITA and biosimilar HUMIRA in the U.S.? Our sense is that payers may view the imperative is simply being to offer the best-priced product to their constituents. And I'm wondering whether with enough additional rebate, maybe branded HUMIRA ends up being that lowest-priced product. So my question -- 2 questions, really. Do you agree that the most important driver of what product payers choose to prioritize going to be net price? Or are there other factors at play? And then is it in the realm of possibilities that branded HUMIRA ends up being that lowest-priced product?

我還能在美國重新選擇安傑維他（AMJEVITA）和生物類似藥修美樂（HUMIRA）嗎？我們感覺，支付方可能認為首要任務是為他們的患者提供價格最優的產品。我想知道，如果能獲得足夠的額外回扣，品牌藥修美樂最終會不會成為價格最低的產品。所以我的問題——實際上是兩個問題。您是否同意，支付方選擇優先考慮哪種產品的最重要驅動因素是淨價？還是還有其他因素在作用？品牌藥修美樂最終成為價格最低的產品是否可能？

Yes, thanks. It's an important driver, obviously. Net price is definitely something that the pharmacy benefit managers are focused on as are the upstream insurers, but not the only one. And I think this is where we've been able to successfully differentiate our biosimilars in the past, and we are confident we'll be able to do that on a go-forward basis. And what I would describe, and I've described this before, is that we can go to a pharmacy benefit manager and say, "We can make the transition from brand HUMIRA to AMJEVITA as seamless as possible." We have field force deployed that call on prescribing rheumatologists and GI physicians that treat these patients. We have patient programs that rival the innovative compound because we're also in the marketplace with innovative compounds, and we've designed these programs over many years. We have patient support to help that patient understand how to administer the product and use their device. We have world-class manufacturing of biologics and sustainability of supply. And we have a really good additional benefit coming with the interchangeability that I mentioned in progress. So that actually does improve confidence on the part of the PBM and the payer because they don't want to have their patients have a bad experience transitioning from brand to biosimilar.

是的，謝謝。這顯然是一個重要的驅動因素。淨價無疑是藥品福利管理機構和上游保險公司關注的重點，但並非唯一關注點。我認為，這正是我們過去能夠成功實現生物相似藥差異化的關鍵所在，而我們有信心在未來繼續保持這一優勢。我之前也提到過，我們可以向藥品福利管理機構表示：「我們可以盡可能地讓患者從品牌藥阿達木單抗（HUMIRA）過渡到阿達木單抗（AMJEVITA）。」我們已部署了專門的銷售團隊，拜訪治療這些患者的風濕病專家和消化科醫生。我們擁有與原廠藥相媲美的患者支援項目，因為我們本身也在市場上銷售原廠藥，而這些項目是我們多年來精心設計的。我們提供患者支持，幫助患者了解如何使用產品和相關設備。我們擁有世界一流的生物製劑生產能力和可持續的供應保障。而且，正如我剛才提到的，互換性還會帶來一個非常好的額外好處。這確實能增強藥品福利管理機構（PBM）和支付方的信心，因為他們不希望患者在從品牌藥過渡到生物相似藥的過程中遇到不良體驗。

Now is it possible that the biosimilar -- that the brand retains a substantial share even with biosimilars in the market? Yes, of course, that's possible, but we'll wait and see how that plays out.

現在，生物相似藥是否有可能——即該品牌在生物相似藥上市的情況下仍能保持相當大的市場份額？是的，當然有可能，但我們會拭目以待。

Closing comments?

總結發言？

Yes. Thank you, Arvind. And again, thank you all for joining our call. We feel we've been executing well through the first half of the year, and we're looking forward to carrying that momentum into the second half of the year and obviously excited about the ChemoCentryx announcements and what that represents for the future of our inflamm and nephrology franchises as well. So thanks for joining. We look forward to catching up with you after the third quarter.

是的。謝謝你，Arvind。再次感謝各位參加我們的電話會議。我們覺得上半年各項工作進展順利，期待將這股動能延續到下半年。當然，我們也對ChemoCentryx的公告以及它對我們發炎和腎臟病業務未來發展的重要意義感到興奮。感謝各位的參與。我們期待在第三季結束後與大家再次交流。

Great. Thanks, everybody.

太好了，謝謝大家。

This concludes our 2022 Q2 earnings call. You may now disconnect.

本次2022年第二季財報電話會議到此結束。您可以斷開連線了。