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)

我叫傑森，今天我將擔任安進公司 2022 年第二季度財務業績電話會議的會議主持人。 （操作員說明）

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

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

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，歡迎來到我們的第二季度電話會議。今天要講的內容很多，所以我們將繼續前進。

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.

您今天將聽到的一些關鍵主題包括持續的銷量驅動增長、我們尋求內部和外部創新的戰略，後者在我們今天上午宣布收購 ChemoCentryx 時得到了體現。最後，在困難的宏觀環境中導航。我們已經發布了您的背景幻燈片，我們將在今天的演示文稿中使用非公認會計原則財務指標，其中一些陳述將是前瞻性的。我們向美國證券交易委員會提交的文件確定了可能導致我們的實際結果出現重大差異的因素。

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

因此，我想將電話轉給我們的董事長兼首席執行官 Bob Bradway。鮑勃？

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，感謝您加入我們的電話。今天，我們將討論我們第二季度的業績以及我們計劃收購的 ChemoCentryx，我們在座的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.

從我們的經營業績開始。我們在第二季度實現了強勁的銷量增長，單位銷量增長了 10%。我們的創新產品在全球表現良好。 Repatha、Otezla、Prolia 和 EVENITY 在本季度均實現了兩位數的銷售額增長，而我們創新的血液學/腫瘤學組合中的 KYPROLIS、Nplate 和 BLINCYTO 均創造了創紀錄的季度銷售額。

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.

我們的 2 款最新產品 LUMAKRAS 和 TEZSPIRE 都取得了良好的開端。 LUMAKRAS 現在正在全球 25 個國家為非小細胞肺癌患者開處方。 TEZSPIRE 在短時間內為美國廣大的嚴重哮喘患者群體產生了重大影響。隨著我們計劃收購 ChemoCentryx，我們將在我們的產品組合中添加另一款新推出的創新產品 TAVNEOS，該產品用於ANCA 相關性血管炎，這是一種嚴重且有時會危及生命的自身免疫性疾病。 TAVNEOS 是一種了不起的藥物，是 10 多年來該領域的第一項創新，鑑於舊療法的嚴重副作用和疾病的嚴重性，它非常需要。該產品也正好適合安進的戰略優勢。我們在免疫學和腎髒病學領域數十年的領先地位將使我們能夠為 TAVNEOS 的推出增加價值，以比其他方式更快的速度接觸到更多的患者。

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.

稍後你會聽到 Murdo 的消息，但我只想說，這樣的機會並不經常出現。我們非常期待與來自 ChemoCentryx 的高技能和敬業的團隊合作，以實現這一非常創新產品的全部潛力。我們認為我們可以為患者帶來改變，並從這項投資中為我們的股東獲得可觀的回報。

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.

戴夫將很快談論管道。我們的創新和生物仿製藥分子正在通過管道順利進行。當然，重點包括我們的心血管分子 olpasiran 的真正令人鼓舞的數據，我們預計該分子將進入 III 期測試。在腫瘤學方面，來自我們的 BiTE 或幾種實體瘤中的雙特異性藥物的數據讓我們越來越相信這些分子可以在小細胞肺癌和前列腺癌等仍然存在很大未滿足醫療需求的疾病中發揮作用。總體而言，我們的生物仿製藥正在按計劃推進，為我們未來推出該業務的增長做好了準備。

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.

現在讓我談談華盛頓目前的藥品定價辯論。到目前為止，聽到我們對擬議的立法感到失望，你不會感到驚訝。一段時間以來，我們一直在倡導尊重創新並提供更好的創新途徑的改革。擬議的法案也沒有。該法案將實施價格控制，而價格控制將阻礙創新。在我們國家需要更多創新的時候，這項法案的結果將更少。更糟糕的是，該法案對提高患者的藥品負擔能力幾乎沒有什麼幫助。因此，在創新和可負擔性方面，該法案對患者來說是雙輸的。

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，最近的事態發展並不令人意外。一段時間以來，我們一直在將業務定位於壓縮生命週期和價格的世界。如果通過，這項立法將加速這些趨勢，我們將相應地進行調整。我們仍然相信世界需要更多的創新，而不是更少，我們的重點將繼續放在推進更多創新上。在炎症、腫瘤學和普通醫學領域，我們擁有廣泛的創新和生物仿製藥產品組合，可滿足全球患者的需求，我們對長期增長前景仍然感到鼓舞。上半年，我們的團隊表現良好，滿足了我們所服務患者的需求。我感謝他們對我們使命的奉獻。

And let me turn now over to Peter.

現在讓我交給彼得。

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.

謝謝你，鮑勃。首席財務官組織歡迎 ChemoCentryx 加入安進，我們很高興能夠幫助這些團隊為患者服務。我們對本季度的表現感到滿意，並且我們有望實現我們的長期目標。我們繼續看到該公司成功應對外匯逆風、利率上升、通貨膨脹、供應鏈壓力和歐洲戰爭，同時應對 COVID 變種激增。我們感謝安進公司 24,000 名以使命為導向的同事的辛勤工作，並為全球數百萬患者提供服務。

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%.

在討論我們的 2022 年指導之前，我將介紹我們的第二季度財務業績。財務結果顯示在幻燈片的幻燈片 6 上。我們在第二季度有效執行，同比銷量增長 1%，產品銷售增長 3%。剔除外匯影響，收入增長和產品銷售增長分別為3%和5%。與我們重新調整的 2021 年第二季度相比，我們的每股收益增長了 163%，這受到了 2021 年 15 億美元的 Five Prime 進行中研發費用的有利影響。不包括 15 億美元的 Five Prime 費用，非公認會計原則每股收益增長了 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.

轉向產品銷售。 Repatha、Prolia、LUMAKRAS 和 EVENITY 以及產品組合中的許多其他產品推動了 10% 的強勁銷量增長。同比銷量增長被淨售價下降 6% 和外匯逆風 2% 部分抵消。我們已建立的產品組合產生了近 10 億美元的產品銷售額，並繼續提供強大的現金流來為內部和外部創新提供資金，就像今天的 ChemoCentryx 交易一樣。

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.

過渡到我們的生物仿製藥。 AMGEVITA 仍然是歐洲處方最多的阿達木單抗生物類似藥，我們正在為 2023 年 1 月在美國推出該產品做準備和興奮。其他約 3 億美元的收入同比下降 24%，主要受 COVID-19 抗體下降的推動協作收入與 2021 年第二季度相比。非 GAAP 運營費用同比下降，主要是由於我之前提到的 2021 年 15 億美元的 Five Prime 相關費用。回想一下我們第一季度的討論，我們已經更新了我們的非公認會計原則政策，不再根據美國證券交易委員會今年發布的指南將此類費用從我們的非公認會計原則結果中排除。

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.

出於比較目的，我們 2021 年的非 GAAP 運營費用現在將包括之前排除的 2 個項目。首先，記錄在 2021 年第二季度與 Five Prime 相關的 15 億美元在收購過程中的研發。其次，記錄在與 2021 年第三季度從協和麒麟公司獲得 AMG 451 許可權的預付款有關的研發中記錄的 4 億美元。 21 年第二季度，Five Prime 進行中的研發費用為 15 億美元的影響，第二季度非 GAAP 總運營費用同比下降 5%，反映了數字化、流程簡化和自動化推動的持續改進，超過抵消投資以推進我們的管道和支持產品發布。

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.

在非公認會計原則的基礎上，銷售成本佔產品銷售額的百分比同比下降 2.2 個百分點至 14.7%，主要是由於 COVID-19 抗體出貨量和直接製造成本下降，部分被不斷發展的成本所抵消產品組合。第二季度非 GAAP 研發支出同比下降 2%，主要是由於市場產品支持減少，部分被研究和早期管道支出增加所抵消。第二季度非 GAAP SG&A 費用同比下降 2%。我們繼續專注於優先考慮關鍵投資和活動，同時提高生產力。

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.

非 GAAP 其他收入和支出在第二季度淨支出 4.1 億美元。這是由於我們使用權益會計法而產生的淨利息費用和我們在百濟神州業績中的份額。我們擁有強大的資產負債表，產生大量現金流，並保持顯著的財務靈活性，以執行戰略業務發展機會。我們繼續執行我們的資本配置優先事項。首先，今天宣布收購 ChemoCentryx 是投資最佳創新的一個很好的例子，無論是內部還是外部。其次，通過資本支出投資我們的業務，包括我們在俄亥俄州和北卡羅來納州正在建設的新環保設施。第三，通過增加股息向股東返還資本，包括本季度每股 1.94 美元，比上一季度增加 10%。第四，機會性股票回購。雖然我們在 2022 年第二季度沒有股票回購，但到 2022 年第一季度為 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.

讓我們轉向 2022 年的業務前景。我們對 2022 年上半年取得的進展感到高興，我們繼續對我們成長品牌的軌跡充滿信心。根據最近的匯率，我們現在預計全年將吸收 5 億美元的外匯逆風來應對產品銷售，其中我們在上半年吸收了 2 億美元。反映我們迄今為止的有效執行，同時考慮到具有挑戰性的外匯動態，我們將 2022 年的收入指導範圍縮小至 255 億美元至 264 億美元。我們的 17 美元至 18 美元的非公認會計原則每股收益範圍保持不變。根據最近的外匯匯率，這一範圍包括全年約 3% 或 0.45 美元的外匯逆風。在這 0.45 美元中，我們在上半年經歷了大約 0.20 美元，因此我們預計下半年每股收益的外匯逆風將增加 0.25 美元。我們的非公認會計原則每股收益範圍還包括與我們收購 ChemoCentryx 相關的成本。外彙和 ChemoCentryx 都會影響我們在該範圍內的表現。

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.

我將分享一些在 2022 年剩餘時間內需要考慮的其他要點，特別關注這些趨勢可能如何影響第三季度和第四季度。首先，我們預計第三季度和第四季度產品銷售的外匯逆風每季度約為 1.5 億美元，下半年總計 3 億美元。這些不利因素在美國以外規模較大的品牌中最為明顯，例如 Prolia、Aranesp、AMGEVITA、Vectibix 和 XGEVA。其次，預計 MVASI 和 KANJINTI 的負定價趨勢將在下半年繼續。我們預計這些產品在今年剩餘時間裡的產品銷售額將出現環比下降。我們預計 KANJINTI 全年銷售額約為 3 億美元，MVASI 全年銷售額約為 8.5 億美元。正如我們所指出的，生物仿製藥的增長將受到新產品和新地區的推動，我們期待成為 2023 年 1 月與 AMGEVITA 在美國推出的 HUMIRA 的第一個生物仿製藥。第三，我們預計第三季度 ENBREL 產品銷售額接近第二季度 ENBREL 產品銷售額。四、全年，我們現在預計 Neulasta 產品銷售額將在 10 億美元至 11 億美元之間。這與我們之前的 9 億美元至 10 億美元不同。我們預計 Neulasta 的負面定價趨勢將在下半年繼續。第五，儘管我們預計這些因素的淨影響將導致第三季度的收入和每股收益低於第二季度，但我要重申，我們的全年每股收益指引保持在 17 美元至 18 美元不變。我們現在預計 2022 年的其他收入將在 14 億美元至 16 億美元之間，而我們之前的範圍為 14 億美元至 17 億美元。我們對 2022 年非 GAAP 總運營費用的預期與我們上次談話時沒有變化。我們繼續預計，與今年上半年相比，今年下半年的運營費用將增加，包括對我們管道的重要投資以及當前和即將推出的產品，包括 23 年 1 月的 AMGEVITA 和增加研發第三季度和第四季度的支出。我們繼續預計 2022 年非 GAAP 營業利潤率佔產品銷售額的百分比約為 50%。我們繼續預計非 GAAP 銷售成本佔產品銷售額的百分比為 15.5% 至 16.5%。根據我們重鑄的 2021 年結果，我們對 2022 年非 GAAP 研發的預期保持不變，其中現在包括第三季度與 KKC 獲得 AMG 451 許可相關的 4 億美元費用，我們預計 2022 年非 GAAP 研發費用現在相當於同比下降 4% 至 6%。我們預計非 GAAP SG&A 支出佔產品銷售額的百分比將同比持平或略有下降。我們繼續預計其他收入和支出將在 16 億美元至 18 億美元之間，由於利率上升和我們在百濟神州業績中的份額，第三季度將比前兩個季度的運行率增加。

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，對於全年，我們預計非 GAAP 稅率範圍為 14.0% 至 15.0%，高於我們之前的 13.5% 至 14.5% 的指導。儘管逆風持續，我們仍將在 2022 年剩餘時間內有效執行。我們將繼續投資於最好的創新。我們期待在 23 年 1 月推出 AMGEVITA，推動 TEZSPIRE 和 LUMAKRAS 的推出，推進我們的管道，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。我會把它交給默多。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，彼得。在銷量增長 10% 的推動下，第二季度產品銷售額同比增長 3%。剔除外匯影響，全球產品銷售額增長 5%。我們為 Prolia、EVENITY、AMGEVITA、KYPROLIS、Nplate 和 BLINCYTO 實現了創紀錄的季度銷售額，並為包括 Repatha 和 LUMAKRAS 在內的幾種其他產品實現了兩位數的銷量增長。我們的前美國業務增長 5%，銷量同比增長 20%。除了強勁的第二季度，我個人還對我們宣布收購 ChemoCentryx 以及有機會幫助患有嚴重活動性 ANCA 相關血管炎（一種嚴重且可能危及生命的自身免疫性疾病）的患者感到興奮。當我評論我們的炎症產品組合的表現時，我會更多地談論 TAVNEOS。

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.

我將從我們的普通醫藥業務開始，其中包括 Prolia、EVENITY、Repatha 和 Aimovig。在銷量增長 24% 的推動下，該投資組合的總收入同比增長 17%。在骨骼健康方面，Prolia 的銷售額同比增長 13%。由於新患者和重複患者的增加，銷量增長了 12%。 EVENITY 本季度銷售額達到創紀錄的 1.91 億美元，主要受美國銷量增長 60% 和美國以外地區銷量增長 37% 的推動。第二季度 ENBREL 銷售額同比下降 8%，主要是由於淨銷售額下降銷售價格和數量。由於其長期的療效和安全性記錄，ENBREL 仍然是一種常用的處方療法。

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.

我們推出的 TEZSPIRE 開局非常強勁，第二季度銷售額為 2900 萬美元。我很高興地看到，過敏症專家和肺病學家都為廣泛的嚴重哮喘患者開出了 TEZSPIRE。我們還看到在未接受過生物治療的患者和先前接受過治療的患者中開始使用。在准入方面，TEZSPIRE 是一種醫療福利產品，截至 7 月 1 日，我們獲得了永久報銷編碼。醫生承認 TEZSPIRE 獨特的差異化特徵及其在治療全球 250 萬不受控製或符合生物學條件的嚴重哮喘患者方面的廣泛潛力沒有任何表型和生物標誌物限制。

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，我們收購 ChemoCentryx 的協議為我們領先的炎症和腎髒病學組合與 TAVNEOS 帶來了一個令人信服的機會，TAVNEOS 是最近推出的針對 ANCA 相關血管炎或 AAV 的一流治療方法。讓我花點時間談談我認為 TAVNEOS 對患者的重要性。 AAV 是一種嚴重的全身性自身免疫性疾病。它會導致炎症並最終破壞小血管。這種炎症過程會導致永久性器官損傷，在某些嚴重的情況下，可能會危及生命。 TAVNEOS 代表了每年 8,000 至 10,000 名發生嚴重活動性疾病或經歷 AAV 嚴重複發的美國患者的治療選擇的重大進步。我們期待與 ChemoCentryx 的才華橫溢的團隊會面並合作，我相信通過應用安進在炎症和腎髒病學方面的豐富經驗以及大量的市場佔有率，我們可以通過 TAVNEOS 幫助更多的 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.

轉向我們的血液學和腫瘤學業務。我們的 6 款創新產品同比增長 14%，銷量增長 11%。這是由 KYPROLIS、Nplate 和 BLINCYTO 的強勁銷量增長推動的，我們預計這一趨勢將持續到今年。 XGEVA 第一季度銷量下降 2%，第二季度同比持平。我們推出的 LUMAKRAS 進展順利，第二季度收入為 7700 萬美元，環比增長 24%。在美國，1,900 多名醫生為 3,000 多名患者開出了 LUMAKRAS 處方，我們已經看到在大多數非小細胞肺癌患者接受治療的社區環境中得到廣泛採用。不幸的是，雖然美國有 85% 的患者接受了 KRAS G12C 狀態檢測，但只有 50% 的時間腫瘤學家可以得到這些檢測結果來支持二線治療決策。我們的團隊正在消除障礙，以確保腫瘤科醫生能夠在患者進展超過一線治療時審查 KRAS G12C 狀態。我們已經看到，當在二線環境中已知 KRAS G12C 狀態時，85% 的患者接受 LUMAKRAS。在美國以外，LUMAKRAS 現已在 40 多個國家獲得批准，我們正在 25 個市場積極推出，並在其餘國家迅速尋求報銷。

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.

我們的腫瘤生物仿製藥銷售額同比下降 24%，而我們的 MVASI 和 KANJINTI 生物仿製藥均持有領先份額。我們預計，在競爭加劇的推動下，淨售價將繼續惡化，銷量將繼續下降。總的來說，我們的生物仿製藥產品組合已成為行業領先的特許經營權，累計貢獻了 55 億美元的產品銷售額。展望未來，我們對即將於 2023 年 1 月在美國推出的 AMGEVITA 感到興奮，隨後將推出下一波針對 STELARA、EYLEA 和 SOLIRIS 的生物仿製藥。

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，我對我們在本季度的執行和銷量增長、我們不斷擴大的國際影響力和多樣化的產品組合感到非常滿意，包括令人興奮的 TAVNEOS 的加入使我們能夠很好地實現我們的長期增長戰略。

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

有了這個，我會把它交給戴夫。

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。我想首先分享我對我們今天宣布的交易的興奮。如您所知，ANCA 相關性血管炎是一種嚴重且有時會危及生命的疾病。在親自治療了這些患者之後，我完全理解他們面臨的挑戰以及 TAVNEOS 在解決這一重大未滿足需求方面的好處。我期待與 ChemoCentryx 的團隊合作。

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.

對於研發，第二季度是持續執行的一個季度，我們宣布了幾個項目的新數據，並繼續推進我們強大的創新臨床管道。

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.

從炎症開始。 7 月，TEZSPIRE 被歐盟人用藥品委員會推薦用於治療嚴重哮喘，並在加拿大獲得批准。我們啟動了 SUNRISE III 期研究，旨在評估 TEZSPIRE 在減少口服皮質類固醇依賴型哮喘成人患者中使用口服皮質類固醇的有效性和安全性。 ROCKET III 期計劃在 6 月啟動了評估 rocatinlimab （一種創新的抗 OX40 單克隆抗體）在中度至重度特應性皮炎患者中的療效。在與監管機構和我們的合作夥伴進行進一步討論後，我們正在修改這些研究，以進一步提高患者的便利性並研究一系列劑量。沒有出現安全性或有效性問題。我們繼續對該項目在特應性皮炎方面的廣泛潛力感到非常興奮。

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.

在腫瘤學方面，我們將在即將召開的世界肺癌大會上展示我們兩個胸科項目的數據。第一個是 tarlatamab，一種針對 DLL3 的 HLE BiTE 分子，正在對經過大量預處理的小細胞肺癌患者進行研究，這是一個幾乎沒有治療選擇的人群。在這種情況下，tarlatamab 表現出有希望的抗腫瘤活性和顯著的反應持久性。我們期待在世界會議上展示更新的數據集，並繼續在本研究中招募患者參加一項潛在的註冊 II 期試驗——在這種情況下。

We're also investigating tarlatamab in combination with standard of care in first-line small cell lung cancer in combination with AMG 404, a PD-1 inhibitor, in patients with second line or later small cell lung cancer and in neuroendocrine prostate cancer.

我們還在研究 tarlatamab 與一線小細胞肺癌護理標準聯合 AMG 404（一種 PD-1 抑製劑）在二線或晚期小細胞肺癌和神經內分泌前列腺癌患者中的應用。

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.

我還將介紹我們的 LUMAKRAS 檢查點抑製劑和 SHIP2 組合研究的數據。前者的數據被禁運到 8 月 7 日，所以我們今天不能討論結果。我們可以說的是，由於耐受性問題，PD-1 很難與其他靶向藥物結合使用。我們將展示這項研究的綜合數據集。提醒一下，我們正在研究一線治療非小細胞肺癌的多種潛在途徑，其中 LUMAKRAS 可能按 PD-L1 表達水平分割，其中非小細胞肺癌群體分解為大約 1/3 PD-L1高表達、低表達和PD-L1陰性表達。我們已經在 PD-L1 陰性人群中看到了有希望的早期數據。根據與監管機構的討論，我們計劃啟動 LUMAKRAS 聯合化療一線治療晚期或轉移性非小細胞肺癌的 III 期研究。

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.

雖然數據集較小，但我們對 LUMAKRAS 與 Revolution Medicines 的 SHIP2抑製劑 RMC-4630 組合的有效性和安全性感到非常鼓舞。在既往未接受 KRAS G12C 抑製劑治療的患者中，接受最高 2 劑 RMC-4630 聯合 LUMAKRAS 的 4 名非小細胞肺癌患者中有 3 人確認部分緩解，所有 4 人疾病控制。

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.

在胃腸道癌方面，我們也很高興地宣布，LUMAKRAS 聯合 Vectibix 在難治性 KRAS G12C 突變的結直腸癌中的全劑量擴展 Ib 期研究的數據被接受在 9 月舉行的歐洲醫學腫瘤學會大會上發表。 FIGHT 研究的最終分析，II 期隨機、雙盲、對照試驗評估 bemarituzumab、成纖維細胞生長因子受體 2b、FGFR2b、靶向單克隆抗體和改良 FOLFOX6 用於先前未治療的晚期胃癌和胃食管結合部癌患者已完成.這些結果繼續證明 bemarituzumab 加改良的 FOLFOX6 改善了 FGFR2b 表達腫瘤患者的臨床結果，沒有新的安全問題。隨著 FGFR2b 表達水平的增加，觀察到了更大的生存益處。

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，我們公佈了 Olpasiran 的 II 期研究的頂級數據，我們的小干擾 RNA 靶向 Lp(a)。這些數據表明，在主要終點第 36 周和治療期結束的第 48 週，Lp(a) 從基線顯著降低高達或超過 90%，對於大多數劑量，範圍從每一次給藥頻率為 12 周至每 24 週一次。在此治療期間未發現新的安全問題。這些結果預計將在今年下半年的醫學大會上公佈。我們對這種創新分子感到非常興奮，並正在迅速啟動 III 期結果研究。

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.

AMG 133 是我們的多特異性藥物，可抑制胃抑制多肽受體 GIPR 並激活胰高血糖素樣肽 1 GLP-1 受體，已完成註冊。我們計劃向今年晚些時候舉行的醫學大會提交 I 期研究的初始隊列數據，並正在積極規劃該分子的 II 期計劃。

In conclusion, with an innovative portfolio where approximately 3/4 of our clinical stage programs have first-in-class potential and a growing portfolio of biosimilars, we are well positioned to continue to deliver important new medicines for patients and growth for shareholders over the near and long term.

總之，憑藉我們約 3/4 的臨床階段項目具有一流潛力的創新產品組合和不斷增長的生物仿製藥產品組合，我們有能力繼續為患者提供重要的新藥並為股東提供增長近期和長期。

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

有了這個，我將把它轉回給 Bob 詢問問題和答案。

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

好的。謝謝你，戴夫。 Jason，你能提醒我們的來電者提問的過程嗎？

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

（操作員說明）我們的第一個問題來自 Jay Olson 和 Oppenheimer。

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?

祝賀 ChemoCentryx 的交易。這看起來是一個非常令人興奮的機會，可以治療 AAV 中醫療需求未得到滿足的患者。您能否談談協同效應，特別是收入協同效應潛力以及 ChemoCentryx 在您組織內的戰略契合度？

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。我們——正如你所知道的，我們對合身感到興奮。我們希望我們在炎症和腎髒病學領域的團隊能夠將這種產品添加到安進公司中而感到興奮。就協同效應而言，顯然，這是一個非常合適的選擇，但我們專注於投資和發展這個機會。我們認為我們看到了一些機會，可以幫助 ChemoCentryx 的團隊接觸到比目前更多的患者。所以我們的重點將放在這一點上。因此，除了重申我們對此感到興奮之外，我認為目前我們真的沒有太多要說的了。我認為它解決了市場的一個重要需求。對於那些沒有很好的替代方案的患者來說，這有很大的不同。

Our next question comes from Chris Raymond with Piper Sandler.

我們的下一個問題來自 Chris Raymond 和 Piper Sandler。

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.

也許就在——還有另一個問題可能涉及到 TAVNEOS。另外，如果我可以談談，鮑勃，您對與這筆交易相關的藥品定價立法的評論。所以我認為你們指出，在商業方面，腎病和炎症的存在對你們來說是獨一無二的。也許只是給你更多的顏色，你打算如何利用這兩種力量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.

然後也許是第二部分，這種藥物定價語言，有相當多的焦慮，特別是圍繞著針對小分子的規定，並允許 CMS 在第 9 年進行談判。所以 ChemoCentryx 主要是一家小分子公司。如果你願意的話，也許只是解決這兩個問題。

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

當然。默多，你為什麼不從第一個問題開始？

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。謝謝你的問題，克里斯。我們顯然對 TAVNEOS 在我們的產品組合中的非常好的戰略契合感到滿意。 ChemoCentryx 團隊主要專注於風濕病學，並且有風濕病學家的亞專科治療了很多 AAV 患者。所以到目前為止，他們一直非常專注於他們的商業努力。我們可以更廣泛地擴展。鑑於我們目前的在線炎症業務，我們在風濕病學方面擁有全國足跡。我們還可以添加腎髒病學。我應該說，鑑於 AAV 的表現之一是腎功能損害或腎臟炎症，這些患者中約有 1/3 最終被腎科醫生診斷出來。這就是直接的好處。

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.

但我們也有資源，比如我們的患者支持計劃、我們的醫療團隊、我們的機構大客戶經理、我們與付款人合作的能力，以確保醫療政策和事先授權對提供者和患者來說是無縫的。因此，除了目前非常專注但非常有效的 ChemoCentryx 工作之外，我們還可以帶來很多東西。

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.

關於華盛頓，克里斯，顯然，我們在立法的背景下評估了這一點，目前正在通過參議院的潛在立法。雖然正如您所指出的，這是一種小分子產品，但與其他可能受到立法中隱含或隱含的價格控制的小分子相比，我們預計該產品不會有任何特殊風險。因此，我們再次認為這是一款有吸引力的產品。臨床概況看起來非常適合市場需求，我們很高興能與他們一起加入團隊。

Our next question comes from Salveen Richter with Goldman Sachs.

我們的下一個問題來自高盛的 Salveen Richter。

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?

也許只是這裡的後續行動。我很想更深入地挖掘你在準備好的評論中所說的關於這項立法的通過加速了重新定位業務和管理生命週期的趨勢。鑑於您的財務實力，您認為這會增加併購的緊迫性嗎？如果是這樣，鑑於關於非孤兒產品與孤兒產品的爭論，哪些類型的目標可能有意義？還有一個關於 AMJEVITA 的第二個問題，作為第一個進入市場的人，也許您可以讓我們了解一下您和這裡的早期付款人討論如何定位？

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，你會抓住第二個，默多？我將再次討論第一個問題，即關於華盛頓的 Salveen，如你所知，這仍然是一項潛在的立法。所以我們會仔細觀察它是否被通過，如果是，究竟是什麼被通過了。所以我認為在這一點上，我們不會說比我在開幕詞中所說的更具體的內容，那就是我們一直在倡導改革，以促進創新並改善患者獲得它的機會，我們會擔心通過的立法沒有做這兩件事。

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.

Salveen 在 AMJEVITA 上，顯然，我們很高興我們在明年 1 月底在美國推出 AMJEVITA 時率先走出大門。我們對AMGEVITA在美國以外的表現感到滿意，在那裡我們以高份額建立了市場領導地位，儘管存在競爭，我們仍然能夠保持這一地位。顯然，鑑於付款人和報銷結構，美國市場是一個不同的市場，但我們相信我們能夠在啟動生命週期的早期為 AMJEVITA 建立良好的訪問和覆蓋範圍。我們認為 PBM 和付款人有興趣確保他們的患者和成員擁有生物類似藥的可用性和選擇。所以一切順利，按計劃進行。謝謝。

Our next question comes from Umer Raffat with Evercore ISI.

我們的下一個問題來自於 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?

我今天會問2，如果可以的話。一個在您的交易上，一個在季度上。也許從季度更新開始。我看到您的合作夥伴以及您的新聞稿中談到了安全問題——抱歉，談到了 OX40 計劃缺乏安全問題，但是，可能需要改變給藥方案。我想我的問題是，如果沒有安全問題，是否可以假設生物標誌物發生變化，可能是患者子集的 TH 嚴重下降，這可能會促使這種監管反饋？如果您能提醒我們您目前在 III 期每 2 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?

然後關於 ChemoCentryx 的交易，我認為這是一個有趣的案例研究，關於臨床數據的位置與商業接受度的好壞。但是可以公平地假設你不會推進這筆交易，除非他們現在已經有 700 多名患者，並且他們的最高患者指導是 6,000 人？

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

好的。戴夫，你想拿第一個嗎？

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，Umer。關於 OX40，是的，沒有安全問題，也沒有生物標誌物問題，任何類型的患者亞群都沒有變化。正如我在開始準備的評論中所說的那樣——這實際上是由與 FDA 正在進行的討論以探索更廣泛的劑量範圍推動的，我們認為，我們藉此機會提高了患者的便利性。我不會想太多，也不會讀到比這更多的東西。而且我們認為這不會影響整個計劃時間線。

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。而且，Umer，我不確定您在具體問題中要尋找什麼。但是默多，繼續前進，隨時加入。

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 之旅。我認為這裡每個人都必須記住的是這種疾病的性質。我的意思是這是一種嚴重的急性自身免疫性炎症，涉及肺、腎，有時還涉及皮膚和其他器官，如果不進行有效、高效和快速的治療，可能會導致永久性終末器官損傷。目前的護理標準是患者難以忍受的治療方法。而且，如果您可以乾預並提高該患者在前 52 週內保持無復發的潛力，作為風濕病學家或腎病學家，如果您 - 您所要做的就是將 TAVNEOS 添加到他們的基礎治療方案中，您將去做。所以我認為這裡的行為改變是許多醫生選擇做的。正如您所提到的，在此次發布的早期階段，這一點令人鼓舞。

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.

但我們喜歡 TAVNEOS 的原因是它通過將 TAVNEOS 添加到當前的護理標準中並可能減少糖皮質激素的使用來幫助減少患者的潛在復發。所以這是一個疾病領域，如果我們自己進行開發，它將完全符合我們的戰略。所以它進入了一個強大的炎症組合，我們認為我們的規模、商業和醫療能力將使我們能夠加速已經很好的發布。

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.

我想說，Umer，我們顯然很有吸引力，因為它仍處於發布的早期階段，我們認為我們可以為此增加價值，來自市場的反饋一直令人鼓舞。開處方者和基於患者的市場。

The next question comes from Michael Yee with Jefferies.

下一個問題來自 Jefferies 的 Michael Yee。

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.

也許對大衛來說。我知道即將發布的數據，您談到了與 PD-1 結合的挑戰。所以也許你可以適當地調整你的期望。由於毒物，前進的標準是否相當高？您對前線的關注真的與化療相結合嗎？所以也許只是在那裡發表評論。

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?

如果你能偷偷溜進去第二個。您實際上在幻燈片上談到了 AMG 133。我知道有很多焦點，顯然，肥胖。你能評論一下我們應該知道什麼來推動這一進程嗎？

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。所以就 LUMAKRAS/PD-1 組合而言，很明顯，由於禁運，我不能說太多。我們將在周日下午在維也納展示這些數據。正如你——當我們考慮一線發展時，我喜歡考慮 3 類患者，那些腫瘤是 PD-L1 陰性的，那些 PD-L1 低到中等的和那些 PD-L1高表達者。正如我所提到的，正如您在 PD-L1 陰性人群中所了解的那樣，我們正在推進 LUMAKRAS 加化療 III 期試驗。然後我們將在維也納披露檢查點抑製劑數據的結果，並概述我們在該領域的進一步發展計劃。我想這大概就是我現在能說的了。但我真的會將其視為不同的患者群體，其中將根據 PD-L1 表達針對他們的特定腫瘤量身定制治療方法。

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.

在 AMG 133 上，是的，對我們在那裡取得的進展非常滿意。正如我所提到的，我們完成了第一階段的註冊。我們希望展示這一點。我們正在提交——正在提交給醫學大會的過程中。我們正在非常積極地規劃第二階段計劃的樣子，隨著我們的計劃在未來幾個月內最終確定，我們將有更多話要說。

Our next question comes from Matthew Harrison with Morgan Stanley.

我們的下一個問題來自摩根士丹利的 Matthew Harrison。

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?

偉大的。鮑勃，如果我能問一下您對 BD 和併購的看法。我們看到您在去年進行了 2 筆規模適中的資產交易，其中包含一些管道。你如何看待繼續做更多這樣規模的交易而不是更大、更具變革性的交易？您如何看待您在添加資產方面的位置與您想要的位置？

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，我不認為有什麼改變。我們繼續尋找投資業務的方法。我們的重點是試圖找到最好的創新，並努力推進這一點，特別是在我們已經明確表示感興趣的領域，比如炎症、腫瘤學和普通醫學領域。所以我們繼續看。顯然，中小型企業的機會比大型企業多得多。但是，正如我在任職期間一直所說的那樣，馬特，我們感到有責任考慮所有為股東增加價值的選擇，我們將繼續這樣做。

Our next question comes from David Risinger with SVB Securities.

我們的下一個問題來自 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?

所以我的問題與理解可互換的生物仿製藥有關。請有兩部分。首先，很明顯，AMJEVITA 在明年上半年處於有利地位。但是，您能否談談該產品與 23 年下半年推出的可互換生物仿製藥競爭的能力，因為 AMJEVITA 沒有該名稱？

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?

然後另一部分是幾天前剛剛發布的消息，即使從未進行過轉換研究，FDA 批准的生物仿製藥 Lucentis 也可以互換。所以我想知道這是否表明您的 ABP 938 或生物仿製藥 EYLEA 也可能被批准為可互換產品？

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，大衛，這個問題。我現在想說的是，在我們與付款人和保險公司以及醫生的對話中，可互換性並不是讓他們將 AMGEVITA 視為創新者的一種選擇和替代方案的障礙。我們正在追求與 AMGEVITA 的互換性，我們預計這些數據將在發布的晚些時候讀出。因此，我認為，如果它們具有可互換性，我們首先推出的現有職位將有助於在他們進入時抵禦額外的競爭。我們的期望至少是一對夫婦的意願。但我們將快速跟進我們自己的可互換性數據。因此，競爭優勢可能在市場上存在或持續存在的時間很短。至於 ABP 938，我不會推測 FDA 可能會說什麼。謝謝你。

Our next question comes from Mohit Bansal with Wells Fargo.

我們的下一個問題來自富國銀行的 Mohit Bansal。

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?

也許還有關於 LUMAKRAS III 期研究的問題。那麼戴夫，您認為在這項特定研究中，與多西他賽相比，您認為有什麼臨床意義的益處？另一個問題，問題的另一部分基本上是，如果你考慮 IO 後的化療，化療往往會做得很好。你認為在這個特定的試驗中安慰劑反應會比歷史更好嗎？

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.

所以是的，就第三階段研究而言，它有望在本季度報告。這是一個事件驅動的試驗。如果我們看到 LUMAKRAS 的行為與我們迄今為止在整個項目中觀察到的晚期肺癌的行為一致，我認為我們將在那里處於有利位置。該試驗有 90% 的功效來檢測無進展生存期的顯著差異。所以它的動力非常好。我相信這將是一項進行良好的研究。因此，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.

就安慰劑反應而言，我認為這很難推測。我們在 PD-L1 陰性患者中進行的試驗是化療加 LUMAKRAS，對照被認為是標準治療組，其中添加檢查點抑製劑具有相對適度的附加益處。因此，根據我們看到的 LUMAKRAS 與化療聯合的初步數據，這讓我們有信心進入 III 期，我們已經與監管機構就該試驗設計進行了富有成效的討論。

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

我們的下一個問題來自美國銀行的 Geoff Meacham。

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.

我想我在 LUMAKRAS 上有一個，Murdo 是商業版的。當您查看過去 3 個季度左右的美國趨勢時，也許只是幫助我們了解您是否達到了 G12C 測試的峰值飽和度。您如何看待在美國以外達到同樣水平的時機？然後，也許很多人都詢問過 III 期組合研究的類型，如果您在查看組合研究數據時會設想高水平的增量機會。

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。謝謝你的問題，傑夫。我想說這與美國的峰值檢測無關，我們已經有大約 85% 的一線患者接受了檢測並獲得了 KRAS G12C 狀態。目前，我們所知道的是，只有一半的二線檢測患者在進展時可以獲得檢測結果。所以這才是我們真正關注的重點。我們專注於那些進展中的患者的測試結果在哪裡，以便治療腫瘤學家可以讓患者受益於 LUMAKRAS。當他們再次進行該測試時，有一半的時間，這些患者中有 85% 會得到 LUMAKRAS。因此，當開處方的醫生知道他們的測試結果時，這些二線患者的滲透率非常高。所以我們還沒有達到頂峰。我們在那裡有更多改進的空間。目前，這些患者中約有一半沒有在進展時對其 KRAS G12C 測試結果進行審查。所以這是團隊關注的重要事情。這就是我們認為我們可以做的事情，以繼續推動美國的一些收入增長。

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，我們再次看到的是兩種市場的故事。在德國、瑞士和法國等市場，生物標誌物測試非常發達，他們的臨床信息系統也非常發達，因此，該測試在二線進展時可用和檢索，我們看到非常迅速的提升和吸收.在不太發達的地方，想想西班牙、意大利，在某種程度上，英國的吸收量更像我們在美國看到的那樣。所以......

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

澄清一下，這是在我們擴展的訪問計劃中。

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。在我們擴大的訪問計劃中，我們已經看到了臨床應用，但我也在談論其他靶向治療的其他經驗。由於測試基礎設施，您將看到某些市場的吸收速度比其他市場慢。所以我們正在與這些市場合作。我們正在與臨床醫生一起改變這種行為。而且我認為我們將能夠成功地在二線生產該產品。然後，當然，如果我們在第三階段獲得確認數據，這樣做會更容易推廣，因為我們不再處於加速批准狀態。希望該數據集具有吸引力，並繼續加強 LUMAKRAS 的價值。

The next question comes from Yaron Werber with Cowen.

下一個問題來自 Yaron Werber 和 Cowen。

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?

偉大的。大衛，這是給你的。關於 TAVNEOS，該藥物在 C3 腎小球病和嚴重 HS、ACCOLADE 和 AURORA 中進行了測試。這些數據有點混雜。我認為他們正在尋找 FDA 對 C3G 的反饋，他們也在考慮狼瘡腎炎，可能會開始另一項研究。有什麼想法——這些跡象表明你支持嗎？

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，亞龍。是的。因此，正如您所指出的，還有其他疾病，其中 TAVNEOS 已被研究，其中補體級聯的這一分支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。我們將查看所有這些數據，與來自 ChemoCentryx 的新同事一起查看項目，並確定可能再次解決目前幾乎沒有有效治療的疾病的最佳前進道路。

Our next question comes from Carter Gould with Barclays.

我們的下一個問題來自於 Barclays 的 Carter Gould。

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?

偉大的。所以我想來你的血紅素/onc特許經營權。您仍然有 BLINCYTO 和 KYPROLIS，但我們看到您在骨髓瘤中使用的最新類型的 BiTE 已停止使用。安進多年來一直在努力擴大其骨髓瘤專營權。這仍然是 - 在優先級方面排名在哪裡？而且我想，更廣泛地說，這對未來在血紅素/onc 競爭所需的創新跳躍有何影響？

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.

我們可以把它分成兩部分。我認為，就 KYPROLIS 而言，顯然，我們對其持續的表現感到鼓舞。更一般地說，血紅素/onc 產品組合，正如您所提到的，您談到了 BLINCYTO 的持續成功。同樣，我們對我們所看到的以及我們認為可以繼續為複發/難治性 ALL 患者做的事情感到非常鼓舞。但我認為你也提出了重要的一點，即多發性骨髓瘤是一個非常擁擠的空間。我們對 701 的決定與我們能否在競爭中領先於市場有很大關係。因此，我們優先考慮那些我們認為我們可以成為一流和一流的藥物。我們正在進行其他可能對多發性骨髓瘤有用的項目。戴夫，你為什麼不跳進去。

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。因此，作為一個領域，看，我們以我們發現的科學和生物學為指導。 AMG 701，這是針對 BCMA 的多個代理的戰略決策。我們選擇將精力集中在 tarlatamab、DLL3 程序上，我們在這方面取得了巨大的領先優勢。我們有一個非常活躍的分子。同一平台是 AMG 701，所以我認為你會看到這種優先級。

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?

祝賀今天早些時候的交易。我實際上想談談您在前列腺癌方面所做的努力。您能否簡單介紹一下您周圍的一些細節，將 160 優先用於較低親和力的 T 細胞 BiTE？剛剛考慮到我們在這個領域看到的最新數據，可能是更新的技術，針對 CD28 和 PSMA 的雙特異性，你認為你的努力如何能在這方面保持競爭力？

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。謝謝你的問題。所以我們現在有一對針對前列腺癌的分子，實際上是 3 個，如果你包括神經內分泌前列腺癌，我們正在進行一項 tarlatamab 研究，其中 DLL3 在神經內分泌腫瘤中的表達非常頻繁。但首先，針對 STP1 的 AMG 509 繼續對我們在該試驗中生成的數據印象深刻，我們正在以所有審慎的速度推進該計劃。我們希望能夠在今年晚些時候或明年某個時候分享首次人體研究中劑量增加的數據。

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.

然後，正如我一直指出的那樣，我們將查看來自 AMG 160、Acapatamab 和 AMG 340 的累積數據，這些數據是通過收購 TeneoBio 獲得的。根據我們所看到的，我們選擇優先考慮未來針對 PSMA 的 AMG 340。您幾天前提到的數據是少數患者。我們在早期階段也看到過類似的事情。我認為您需要的是更多的患者，特別是延長隨訪時間，尤其是在這種疾病中。在這方面，例如，我對我從 AMG 509 看到的東西感到非常鼓舞。因此，這 3 種藥物的組合正在推進。實際上，我對我們在前列腺癌中可能做的事情感到非常樂觀。

Our next question comes from Michael Schmidt with Guggenheim.

我們的下一個問題來自古根海姆的邁克爾施密特。

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?

我在 Aimovig 上有一個。只是想知道您是否可以在這裡評論市場動態，只是考慮到 11% 的銷量下降。這是競爭動態的函數嗎？還是跟定價有關？鑑於這些趨勢，我們應該如何看待峰值潛力？

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。謝謝你的問題，邁克爾。我認為我們對 Aimovig 的關註一直是我們確保我們以合理的淨價格提供良好訪問的方式來解決患者群體、預防患者群體的問題。而且我認為，從戰略上講，我們已經能夠做到這一點。從去年年底到今年，我們確實損失了 1 個主要的 PBM，這影響了銷量的演變。但我們也能夠逐年提高我們的淨定價。所以從盈利的角度來看，Aimovig 做得更好。而且我認為從長遠來看，它在市場上還處於早期階段。考慮到抗體比市場上可用的抗體和較舊的非 CGRP 類抗體要好得多，CGRP 類的增長速度應該更快。當然，我們已經有了口服藥物的出現。所以現在還早。我們仍在觀察它的發展。我們繼續專注於為患有高頻偏頭痛的預防性患者進行推廣，並且我們繼續在這方面做得很好。所以從長遠來看，我認為還有很多等待和觀察。

Our next question comes from Robyn Karnauskas with Truist.

我們的下一個問題來自與 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.

我剛剛有一個關於 Otezla 的問題和一個關於 BiTE 平台的後續問題。所以對於 Otezla 來說，鑑於價格較低的主題和一些數據，將在 9 月批准的新藥，我的意思是，你對定價的想法以及我們應該如何考慮下一個一年或兩年，因為我知道這些新藥需要更多的銷量，但它們可能會給定價帶來一些壓力。

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?

然後在一般的 BiTE 平台上，為了跟進 Evan 的問題，我的意思是，你在什麼時候 - 看到來自 Regeneron 的 Co-stim 的其他公司全面發布的新 bispec 數據好吧，就像你在什麼時候將 BiTE 與新的 bispec 相比，然後將錢用於其他事情？

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.

所以謝謝你的問題，羅賓。我將從 Otezla 的問題開始，即主題進入市場如何影響我們的業務。我認為，總的來說，我們對將自己的標籤擴大到包括輕度患者群體感到非常滿意。令我感到鼓舞的是，在我們與付款人和 PBM 的對話中，我們能夠擴大標籤，將這些患者包括在我們目前的合同保險範圍內，而不會為我們與付款人的交易增加任何價值。因此，我們不必提高回扣率即可將輕度患者群體包括在內。事實上，我們已經看到越來越多的 PBM 和計劃正在取消對 Otezla 的事先授權請求。所以總的來說，我會說我們的訪問權限正在改善很多，而必須支付的費用沒有惡化。我認為你會看到持續的價格壓力，淨價格壓力，是我們以負擔能力向患者提供的共同支付援助。這確實是我們認為 Otezla 在美國的淨價格的動態。

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，我們沒有看到的是由於主題進入者對淨價格的壓力。主題進入者面臨的挑戰是他們還沒有廣泛的付款人覆蓋面。因此，在這種情況發生之前，我認為 Otezla 將繼續在我們為其支付的訪問覆蓋範圍和費率方面做得很好。從長遠來看，我認為這些是直接競爭還是與我們治療的患者類型互補還有待觀察。如果您與皮膚科醫生交談，患者屬於他們不想進行全身治療並繼續使用外用藥物的類別，以及那些願意嘗試外用藥物的類別，因為體表面積受累、牛皮癬的位置、許多因素起作用。這就是我們真正競爭的地方是那些已經決定他們想要一個系統性代理的人。所以我認為他們在很大程度上是不重疊的人群，我們不一定認為這些主題會施加定價壓力。

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

戴夫，你想解決埃文的問題嗎？

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，羅賓。是的，關於 BiTE 平台，我們已經在新一代技術上工作了一段時間，這些技術將結合諸如具有多個目標的邏輯門之類的東西，其中一個和門或一個或門被設計到 BiTE 中以進行激活。這裡真正的目標是做兩件事：一，嘗試提高功效；第二，增加治療窗口，使藥物對正常組織的靶向作用盡可能少。因此，第一批分子正在走向臨床，當我們準備推出時，我們將有更多話要說。

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。我知道我們已經過了一點點，但我們還有幾個問題在排隊。那我們為什麼不多拿幾個呢？然後，如果我們沒有聯繫到您，Arvind 和他的團隊將在今晚出現一段時間。

Our next question is from Dane Leone with Raymond James.

我們的下一個問題來自 Dane Leone 和 Raymond James。

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.

我只是想了解每個人的重點，即估計 LUMAKRAS 在美國的真正機會是什麼。您能否僅定義您對當前研究、當前臨床研究中可能符合 LUMAKRAS 資格的患者的理解，或其他可能參與共同支付援助或其他計劃的患者，他們將接受藥物治療，但只是沒有在商業上支付了藥物？我認為這將是有幫助的，同樣，很明顯，運行率遠低於估計值，人們只是試圖隨著時間的推移對美國的峰值銷售量進行三角測量。

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，但如果我不解決這個問題，請要求澄清。臨床試驗[鋼]率，如果你願意的話，那些沒有參加商業藥物治療但參加其他臨床試驗的患者，在二線非小細胞肺癌患者總數中所佔的百分比相對較小。我會說少於 10% 將是一個估計。它確實有所不同。它會根據其他研究藥物的臨床活動和正在進行的試驗而上下波動。正如我之前回答的一個問題，在二線培養 LUMAKRAS 的主要挑戰是確保當肺癌患者從一線進展到二線時，處方醫生可以獲得 KRAS G12C 測試結果。這就是治療患者旅程中的差距。目前，我們的估計是，大約 50% 的時間會發生這種情況，我們正在努力增加這種情況。當開處方的醫生獲得 KRAS G12C 結果時確實發生了這種情況，10 分中有 8.5 倍的患者獲得 LUMAKRAS。所以我們知道產品的外形有利於那個二線治療的選擇。我們只需要確保我們解決了讓測試結果和二線患者同時會面的管理挑戰。

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.

我們還在提高人們對液體活檢的認識和使用，以便在患者進入二線時對其進行重新測試和重新評估。我希望這能回答你的問題。

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?

我可以回到美國的 AMJEVITA 和生物仿製藥 HUMIRA 嗎？我們的感覺是，付款人可能認為當務之急就是向他們的選民提供價格最優惠的產品。我想知道是否有足夠的額外折扣，也許品牌 HUMIRA 最終會成為價格最低的產品。所以我的問題—— 2 個問題，真的。您是否同意支付者選擇優先考慮的產品的最重要驅動因素是淨價？還是有其他因素在起作用？那麼，品牌 HUMIRA 是否最終成為價格最低的產品？

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.

對了謝謝。顯然，這是一個重要的驅動因素。淨價格絕對是藥房福利經理和上游保險公司關注的重點，但不是唯一的。我認為這是我們過去能夠成功區分我們的生物仿製藥的地方，我們相信我們將能夠在前進的基礎上做到這一點。我要描述的是，我之前已經描述過，我們可以去找藥房福利經理說，“我們可以盡可能無縫地從品牌 HUMIRA 過渡到 AMJEVITA。”我們部署了現場力量，呼籲為這些患者開處方的風濕病學家和胃腸道醫師。我們有與創新化合物相媲美的患者計劃，因為我們也在市場上擁有創新化合物，而且我們已經設計了這些計劃多年。我們有患者支持來幫助患者了解如何管理產品和使用他們的設備。我們擁有世界一流的生物製劑製造和供應的可持續性。我在進行中提到的可互換性帶來了一個非常好的額外好處。因此，這實際上確實提高了 PBM 和付款人的信心，因為他們不希望他們的患者有從品牌過渡到生物仿製藥的糟糕經歷。

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.

現在生物仿製藥是否有可能——即使在市場上使用生物仿製藥，該品牌也能保持相當大的份額？是的，當然，這是可能的，但我們會拭目以待。

Closing comments?

結束評論？

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，阿文德。再次感謝大家加入我們的電話會議。我們覺得我們在今年上半年一直表現良好，我們期待將這種勢頭延續到下半年，並且顯然對 ChemoCentryx 的公告以及這對我們炎症的未來代表著什麼感到興奮和腎髒病專營權。所以感謝您的加入。我們期待在第三季度之後與您聯繫。

Great. Thanks, everybody.

偉大的。謝謝大家。

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

我們的 2022 年第二季度財報電話會議到此結束。您現在可以斷開連接。