艾伯維 (ABBV) 2023 Q3 法說會逐字稿

內容摘要

艾伯維 (AbbVie) 公佈了強勁的季度業績,這得益於其免疫學、神經科學、腫瘤學和美學增長平台的推動。該公司有效管理了 HUMIRA 的生物相似藥競爭並提高了財務前景。艾伯維強調了有前途的研發計劃,並宣布增加股利。

公司基礎業務表現超出預期,SKYRIZI 和 RINVOQ 營收大幅成長。美容產品銷售額下降,但艾伯維對其長期成長前景仍充滿信心。

該公司在免疫學和腫瘤學領域取得了重要的里程碑,並且在管道的所有階段都取得了進展。艾伯維上調了全年指引,並預計 2025 年營收將強勁成長。

該公司專注於擴大現有特許經營權並尋求併購機會。他們對自己管理生物相似藥侵蝕和應對市場挑戰的能力充滿信心。

艾伯維仍然致力於實現股息成長,並擁有強勁的財務前景。

完整原文

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

  • Operator

    Operator

  • Good morning, and thank you for standing by. Welcome to the AbbVie Third Quarter 2023 Earnings Conference Call. (Operator Instructions)

    早安,感謝您的支持。歡迎參加艾伯維 2023 年第三季財報電話會議。 (操作員說明)

  • I would now like to introduce Ms. Liz Shea, Senior Vice President, Investor Relations. Thank you. You may begin.

    現在我想介紹一下投資者關係資深副總裁Liz Shea女士。謝謝。你可以開始了。

  • Elizabeth Shea - SVP of IR

    Elizabeth Shea - SVP of IR

  • Good morning, and thanks for joining us. Also on the call with me today are Rick Gonzalez, Chairman of the Board and Chief Executive Officer; Rob Michael, President and Chief Operating Officer; Jeff Stewart, Executive Vice President, Chief Commercial Officer; Scott Reents, Executive Vice President, Chief Financial Officer; Carrie Strom, Senior Vice President, AbbVie and President, Global Allergan Aesthetics; and Tom Hudson, Senior Vice President, R&D and Chief Scientific Officer.

    早安,感謝您加入我們。今天與我通話的還有董事會主席兼執行長 Rick Gonzalez;羅布·邁克爾,總裁兼營運長; Jeff Stewart,執行副總裁暨商務長; Scott Reents,執行副總裁兼財務長; Carrie Strom,艾伯維資深副總裁兼全球艾爾建美學總裁;以及研發資深副總裁兼首席科學官 Tom Hudson。

  • Joining us for the Q&A portion of the call is Roopal Thakkar, Senior Vice President, Development and Regulatory Affairs and Chief Medical Officer. Before we get started, I'll note that some statements we make today may be considered forward-looking statements based on our current expectations. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in our forward-looking statements. Additional information about these risks and uncertainties is included in our SEC filings. AbbVie undertakes no obligation to update these forward-looking statements, except as required by law. On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions.

    開發和監管事務高級副總裁兼首席醫療官 Roopal Thakkar 參加了電話會議的問答部分。在我們開始之前,我要指出的是,根據我們目前的預期,我們今天發表的一些聲明可能被視為前瞻性聲明。艾伯維警告說,這些前瞻性陳述存在風險和不確定性,可能導致實際結果與我們前瞻性陳述中所示的結果有重大差異。有關這些風險和不確定性的更多資訊包含在我們向 SEC 提交的文件中。艾伯維不承擔更新這些前瞻性聲明的義務,除非法律要求。在今天的電話會議上,將使用非公認會計準則財務指標來幫助投資者了解艾伯維的業務表現。這些非公認會計原則財務指標與我們今天發布的收益報告和監管文件中的可比較公認會計原則財務指標進行了協調一致,這些資料可以在我們的網站上找到。在我們準備好的發言之後,我們將回答您的問題。

  • So with that, I'll turn the call over to Rick.

    因此,我會將電話轉給 Rick。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Thank you, Liz. Good morning, everyone, and thank you for joining us today. AbbVie continues to perform exceptionally well. We once again delivered an excellent quarter with results ahead of our expectations. We are now several quarters into the U.S. biosimilar event for HUMIRA and continue to effectively manage erosion. We've been able to maintain significant volume with the majority of the impact to date driven by lower price.

    謝謝你,莉茲。大家早安,感謝您今天加入我們。艾伯維(AbbVie)繼續表現出色。我們再次交付了出色的季度業績,超出了我們的預期。目前,我們的 HUMIRA 生物相似藥事件已進入幾個季度,並將繼續有效控制侵蝕。我們已經能夠保持大量的銷售量,迄今為止大部分的影響都是由較低價格所推動的。

  • Importantly, our growth platform, the base business, excluding HUMIRA which includes a well-diversified portfolio with multiple leading products in highly attractive markets across Immunology, Neuroscience, Oncology and Aesthetics continues to demonstrate robust performance and outperform expectations. This platform, which is the critical driver in our return to rapid growth in 2025 and beyond, delivered strong double-digit revenue growth this quarter, a considerable acceleration from the first half of this year. We anticipate this platform, which is led by SKYRIZI, RINVOQ, VRAYLAR and BOTOX will continue to drive significant revenue growth going forward.

    重要的是,我們的成長平台、基礎業務(不包括HUMIRA)包括一個多元化的產品組合,在免疫學、神經科學、腫瘤學和美學等極具吸引力的市場中擁有多種領先產品,繼續表現出強勁的業績並超乎預期。該平台是我們在 2025 年及以後恢復快速成長的關鍵驅動力,本季實現了強勁的兩位數營收成長,較今年上半年大幅加速。我們預計這個由 SKYRIZI、RINVOQ、VRAYLAR 和 BOTOX 領導的平台將繼續推動未來營收的顯著成長。

  • At the same time, we have several promising R&D programs with the potential to contribute meaningfully in the latter part of this decade and into the 2030s. This includes next-generation approaches in immunology, a focus on bispecifics, ADCs and novel IO in oncology as well as innovative therapies to potentially treat a range of neuropsychiatric and neurodegenerative disorders.

    同時,我們有幾個有前景的研發項目,有可能在本十年後半段和 2030 年代做出有意義的貢獻。這包括下一代免疫學方法,重點關注雙特異性藥物、ADC 和腫瘤學中的新型 IO,以及潛在治療一系列神經精神和神經退化性疾病的創新療法。

  • In summary, I'm extremely pleased with the continued strong momentum and execution across our business. The growth platform is substantially outperforming our expectations, giving us the confidence to once again raise our financial outlook, including upgraded guidance for floor earnings, which Rob will share momentarily and further underscoring our confidence in AbbVie's long-term outlook. Today, we also announced an increase in our quarterly dividend, which we have grown by more than 285% since our inception. With that, I'll turn the call over to Rob for additional comments on our business performance. Rob?

    總之,我對我們業務持續強勁的勢頭和執行力感到非常滿意。這個成長平台的表現大大超出了我們的預期,使我們有信心再次提高我們的財務前景,包括上調底線收益指引,羅布將立即分享這一點,並進一步強調我們對艾伯維長期前景的信心。今天,我們也宣布增加季度股息,自成立以來我們的股息成長了 285% 以上。這樣,我會將電話轉給 Rob,以獲取有關我們業務績效的更多評論。搶?

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Thank you, Rick. Our results once again demonstrate the strength of our broad portfolio and support AbbVie's long-term growth outlook. We reported adjusted earnings per share of $2.95, which is $0.14 above our guidance midpoint. Total net revenues were $13.9 billion, roughly $225 million ahead of our guidance. The performance of our ex-HUMIRA growth platform continues to be very strong with revenue growth above 12% this quarter, including more than 50% growth from both SKYRIZI and RINVOQ, our best-in-category immunology medicines. We continue to anticipate that these 2 products will collectively exceed HUMIRA peak revenues by 2027 with robust growth expected into the next decade.

    謝謝你,瑞克。我們的業績再次證明了我們廣泛投資組合的實力,並支持艾伯維的長期成長前景。我們公佈的調整後每股收益為 2.95 美元,比我們的指導中位數高出 0.14 美元。總淨收入為 139 億美元,比我們的指引高出約 2.25 億美元。我們的前 HUMIRA 成長平台的業績持續非常強勁,本季營收成長超過 12%,其中我們的同類最佳免疫藥物 SKYRIZI 和 RINVOQ 的營收成長超過 50%。我們繼續預計,到 2027 年,這兩種產品的收入將共同超過 HUMIRA 的峰值收入,並預計在未來十年實現強勁增長。

  • Neuroscience also delivered strong performance, with operational sales growth of more than 20% this quarter, driven by our leading portfolio for migraine and psychiatric conditions. And lastly, Aesthetics performance was highlighted by the return to growth of the U.S. toxin market. This outstanding execution across our well-diversified portfolio gives us the confidence to once again raise our near-term financial outlook. We are increasing our full year revenue guidance by $600 million and have now raised total revenue by $2 billion since our initial guidance in February, including more than $1.4 billion from our ex-HUMIRA growth platform. As a result, we are also raising our full year adjusted earnings per share guidance by $0.25, and now expect adjusted EPS between $11.19 and $11.23.

    神經科學業務也表現強勁,在我們領先的偏頭痛和精神疾病產品組合的推動下,本季營業銷售額成長超過 20%。最後,美國毒素市場恢復成長凸顯了美容領域的表現。我們多元化投資組合的出色執行使我們有信心再次提高近期財務前景。我們將全年收入指引提高了 6 億美元,自 2 月的初步指引以來,目前總收入已提高了 20 億美元,其中包括來自我們前 HUMIRA 成長平台的超過 14 億美元。因此,我們也將全年調整後每股收益指引提高了 0.25 美元,目前預計調整後每股收益將介於 11.19 美元至 11.23 美元之間。

  • Given the strong momentum of our growth platform, which is significantly outperforming our expectations this year, we are now raising the floor guidance for 2024 adjusted EPS to $11, which is $0.30 better than our previous expectations. This floor guidance continues to exclude any impact from IPR&D expense. As is our typical practice, we'll provide our formal EPS guidance range for 2024 on the fourth quarter call. Finally, today, we are announcing a 4.7% increase in our quarterly cash dividend from $1.48 to $1.55 beginning with the dividend payable in February 2024. Since inception, we have grown our quarterly dividend by more than 285%. In summary, I am very pleased with the strong execution across our portfolio. We remain confident in our long-term outlook including a return to robust revenue growth in 2025 with a high single-digit CAGR to the end of the decade. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff?

    鑑於我們成長平台的強勁勢頭,大大超出了我們今年的預期,我們現在將 2024 年調整後每股收益的下限指導提高至 11 美元,比我們之前的預期高出 0.30 美元。本底線指南繼續排除知識產權與研發費用的任何影響。按照我們的典型做法,我們將在第四季度電話會議上提供 2024 年正式每股收益指引範圍。最後,今天,我們宣布,從 2024 年 2 月支付的股息開始,我們的季度現金股息從 1.48 美元增加到 1.55 美元,增加 4.7%。自成立以來,我們的季度股息增加了 285% 以上。總之,我對我們投資組合的強勁執行力感到非常滿意。我們對長期前景仍然充滿信心,包括在 2025 年恢復強勁的收入成長,並在本十年末實現高個位數的複合年增長率。這樣,我會將電話轉給傑夫,請他對我們的商業亮點發表更多評論。傑夫?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Thank you, Rob. We once again delivered strong results across our therapeutic portfolio this quarter. I'll start with Immunology, which delivered total revenues of nearly $6.8 billion, exceeding our expectations. SKYRIZI and RINVOQ continue to demonstrate impressive growth and are now on pace to deliver approximately $11.6 billion in combined sales this year. This performance is especially encouraging, recognizing that we are still in the early launch phase for both assets in IBD, an area of high unmet need where we are very competitively positioned with 2 complementary assets each having generated strong response rates and durable remission across our development programs. SKYRIZI total sales were $2.1 billion, reflecting operational growth of more than 50%.

    謝謝你,羅布。本季我們的治療組合再次取得了強勁的業績。我將從免疫學開始,它的總收入接近 68 億美元,超出了我們的預期。 SKYRIZI 和 RINVOQ 繼續展現出令人矚目的成長勢頭,今年的合併銷售額預計將達到約 116 億美元。這一表現尤其令人鼓舞,因為我們認識到IBD 的這兩種資產仍處於早期啟動階段,這是一個需求未被滿足的領域,我們在這兩個互補資產中處於非常有競爭力的地位,每個資產在我們的開發過程中都產生了強勁的反應率和持久的緩解程序。 SKYRIZI 總銷售額為 21 億美元,營運成長超過 50%。

  • This robust performance includes further share gains in psoriasis, where we remain the clear market leader, capturing roughly 1/3 of the total prescriptions in the U.S. biologic market and approximately 50% of in-play patients who are either new to therapy or switching, increasing momentum in psoriatic arthritis, where SKYRIZI is now the leading in-play biologic therapy in the U.S. dermatology segment as well as continued rapid uptake in Crohn's disease, where we are capturing roughly 1 out of every 4 in-play patients. Importantly, we recently announced positive results from sequence, the ninth and perhaps the most impactful head-to-head study across our development program for SKYRIZI and RINVOQ.

    這種強勁的業績包括在銀屑病領域的份額進一步增長,我們仍然是該領域明顯的市場領導者,佔據了美國生物製劑市場總處方量的約1/3 以及約50% 的新治療或轉換治療的在用患者,銀屑病關節炎的勢頭不斷增強,SKYRIZI 目前是美國皮膚科領域領先的生物療法,並且克羅恩病的治療持續快速發展,我們大約每4 名在場患者中就有1名患克隆氏症。重要的是,我們最近宣布了 SKYRIZI 和 RINVOQ 開發計劃中的第九次、也許是最具影響力的頭對頭研究序列的積極結果。

  • SEQUENCE is a Phase III head-to-head study in Crohn's, which demonstrated SKYRIZI superiority versus STELARA across key efficacy parameters, including impressive statistically significant differences in both clinical and endoscopic remission. The detailed data from this trial were presented earlier this month, and we plan to share the findings more broadly now via our medical personnel and representatives in the field. We anticipate these strong head-to-head results will clearly support SKYRIZI as the best-in-category therapy for Crohn's, which is important for continued rapid share capture. So based on this very positive data as well as our continued momentum, we will be once again raising the full year sales outlook for SKYRIZI. Moving now to RINVOQ, which delivered global sales of $1.1 billion reflecting operational growth of nearly 60% with increasing prescriptions across each of the approved indications.

    SEQUENCE 是一項針對克羅恩病的 III 期頭對頭研究,證明了 SKYRIZI 在關鍵療效參數上優於 STELARA,包括臨床和內視鏡緩解方面令人印象深刻的統計顯著差異。這項試驗的詳細數據已於本月早些時候公佈,我們計劃現在透過我們的醫務人員和現場代表更廣泛地分享研究結果。我們預計這些強勁的頭對頭結果將明確支持 SKYRIZI 作為克羅恩病的最佳治療藥物,這對於持續快速佔領市場份額非常重要。因此,基於這些非常積極的數據以及我們持續的勢頭,我們將再次提高 SKYRIZI 的全年銷售預期。現在轉向 RINVOQ,該公司的全球銷售額達到 11 億美元,反映出隨著每個已批准適應症的處方數量不斷增加,營運增加了近 60%。

  • In particular, I'm very excited about RINVOQ's growth potential in gastroenterology where uptake is exceeding our expectations. In ulcerative colitis, RINVOQ is now capturing more than 25% total in-play patient share in the U.S. second-line plus setting, nearly at parity to the current market-leading therapy. And in Crohn's disease, RINVOQ is ramping very significantly. The inflection we are seeing is even faster when compared to our time-align launch in UC just last year. Given this impressive momentum in IBD, we will now be raising our full year sales outlook for RINVOQ. Global HUMIRA sales were more than $3.5 billion, down 36.2% due to biosimilar competition. The erosion impact in the U.S. played out largely in line with our expectations this quarter, while performance across our international markets is trending better than expected. Turning now to oncology, where total revenues were $1.5 billion. IMBRUVICA global revenues were $908 million, down 20% and consistent with our expectations.

    特別是,我對 RINVOQ 在胃腸病學領域的成長潛力感到非常興奮,該領域的應用超出了我們的預期。在潰瘍性結腸炎方面,RINVOQ 目前在美國第二線及以上治療中佔據了超過 25% 的患者總份額,幾乎與當前市場領先的療法持平。在克隆氏症方面,RINVOQ 的療效非常顯著。與去年我們在 UC 推出的時間調整相比,我們看到的變化甚至更快。鑑於 IBD 的強勁勢頭,我們現在將提高 RINVOQ 的全年銷售預期。由於生物相似藥競爭,全球 HUMIRA 銷售額超過 35 億美元,下降 36.2%。美國的侵蝕影響在本季基本符合我們的預期,而我們國際市場的表現趨勢比預期好。現在轉向腫瘤學,其總收入為 15 億美元。 IMBRUVICA 全球營收為 9.08 億美元,下降 20%,與我們的預期一致。

  • VENCLEXTA global sales were $590 million, up 14% on an operational basis with strong demand for both CLL and AML across our key countries. The U.S. launch of Epkinly in third line plus DLBCL is also tracking well with commercialization also now underway in Europe and Japan, following the recent respective approvals. In Neuroscience, total revenues were more than $2 billion, up 22% on an operational basis. VRAYLAR continues to demonstrate robust growth Global sales of $751 million were up 35.4%, and we have seen a significant uplift in new prescriptions across all indications following the approval as an adjunctive treatment for major depressive disorder late last year.

    VENCLEXTA 全球銷售額為 5.9 億美元,在營運基礎上成長了 14%,主要國家對 CLL 和 AML 的需求強勁。 Epkinly 在美國推出的第三線加 DLBCL 的上市也進展順利,繼最近分別獲得批准後,歐洲和日本的商業化也正在進行中。神經科學領域的總收入超過 20 億美元,營運收入成長 22%。 VRAYLAR 繼續展現出強勁的成長勢頭,全球銷售額達7.51 億美元,成長了35.4%,自去年年底被批准作為重度憂鬱症的輔助治療藥物後,我們看到所有適應症的新處方數量顯著增加。

  • Our leading oral CGRP portfolio for migraine contributed $365 million in combined sales this quarter, reflecting growth of nearly 65% as we continue to see strong demand for both UBRELVY and Qulipta. Atogepant was also recently approved as a new therapy in Europe, branded as Aquipta where it is the only once-daily oral CGRP for prevention of both episodic and chronic migraine, further strengthening our competitive product profile and long-term growth opportunity. Lastly, total BOTOX Therapeutic global sales were $748 million, up 7.4% on an operational basis, reflecting momentum in chronic migraine as well as other approved indications. So overall, I'm extremely pleased with commercial execution across the therapeutic portfolio, especially with our growth platform, which is demonstrating strong revenue growth. And with that, I'll turn the call over to Carrie for additional comments on Aesthetics. Carrie?

    我們領先的偏頭痛口服 CGRP 產品組合本季貢獻了 3.65 億美元的合併銷售額,成長了近 65%,因為我們繼續看到對 UBRELVY 和 Qulipta 的強勁需求。 Atogepant 最近也在歐洲被批准為一種新療法,品牌為 Aquipta,它是唯一每天一次的口服 CGRP,用於預防陣發性和慢性偏頭痛,進一步增強了我們的產品競爭力和長期成長機會。最後,BOTOX Therapeutic 的全球總銷售額為 7.48 億美元,營運基礎上成長 7.4%,反映了慢性偏頭痛以及其他核准適應症的動能。總的來說,我對整個治療組合的商業執行非常滿意,特別是我們的成長平台,它顯示出強勁的收入成長。接下來,我會將電話轉給嘉莉,徵求更多有關美學的評論。嘉莉?

  • Carrie C. Strom - Senior VP of AbbVie & President of Global Allergan Aesthetics

    Carrie C. Strom - Senior VP of AbbVie & President of Global Allergan Aesthetics

  • Thank you, Jeff. Third quarter global Aesthetics sales were approximately $1.2 billion, an operational decline of 4%. In the U.S., Aesthetics sales of $759 million were roughly flat to last year as growth for BOTOX Cosmetic was offset by declines in other brands that continue to be impacted by lower consumer spending related to inflationary pressures. U.S. BOTOX Cosmetic sales were $388 million, an increase of 5%. We are beginning to see a recovery in the U.S. toxin market, which posted positive year-over-year growth in the third quarter following 3 consecutive quarters of declines due to economic pressures.

    謝謝你,傑夫。第三季全球美容銷售額約 12 億美元,營運下降 4%。在美國,美容產品銷售額為 7.59 億美元,與去年基本持平,因為 BOTOX 化妝品的成長被其他品牌的下滑所抵消,而其他品牌繼續受到與通膨壓力相關的消費者支出下降的影響。美國BOTOX化妝品銷售額為3.88億美元,成長5%。我們開始看到美國毒素市場的復甦,在因經濟壓力而連續三個季度下滑之後,第三季較去年同期出現正成長。

  • BOTOX continues to perform very well despite increasing competition. It remains the clear market leader with a strong and stable share, and we have seen little to no share impact from new competitive entrants. U.S. Juvederm sales were $116 million in the third quarter, a decline of 6.4% versus prior year as recovery in the facial filler market continues to lag the cosmetic toxin market. The filler market is improving, however, as a higher priced, more deferrable procedure relative to toxins. This segment of the Aesthetics market continues to be suppressed by lower consumer spending. In the third quarter, the U.S. facial filler market was down low teens percentage compared to the prior year.

    儘管競爭日益激烈,但 BOTOX 仍然表現出色。它仍然是明顯的市場領導者,擁有強大而穩定的份額,而且我們幾乎沒有看到新競爭者對份額的影響。美國 Juvederm 第三季銷售額為 1.16 億美元,比去年同期下降 6.4%,因為臉部填充劑市場的復甦持續落後於化妝品毒素市場。然而,填充劑市場正在改善,因為相對於毒素而言,填充劑市場價格更高、更容易延遲。美容市場的這一部分繼續受到消費者支出下降的抑制。第三季度,美國臉部填充劑市場的百分比與去年同期相比下降了十幾歲。

  • Juvederm remains the market-leading facial filler in the U.S. and share was stable in the quarter. While the U.S. facial injectable markets continue to be impacted by lower consumer spending in this inflationary environment, we are seeing signs of stabilization and even a return to growth in the cosmetic toxin segment. This gives us confidence in a stable to improving outlook in the U.S. as we end this year and enter 2024. Internationally, third quarter Aesthetics sales were $480 million, representing an operational decline of 9.7%. As anticipated, year-over-year performance in the quarter was impacted by a shipment timing benefit we experienced in the third quarter of last year. Results were also impacted by softening economic conditions across major international Aesthetics markets, primarily China.

    Juvederm 仍然是美國市場領先的臉部填充劑,本季份額保持穩定。儘管美國臉部注射市場繼續受到通膨環境下消費者支出下降的影響,但我們看到化妝品毒素領域出現穩定甚至恢復成長的跡象。這讓我們對今年底進入 2024 年時美國前景穩定改善充滿信心。在國際上,第三季美容銷售額為 4.8 億美元,營運下降 9.7%。正如預期的那樣,本季的年比業績受到我們去年第三季經歷的發貨時間優勢的影響。結果也受到主要國際美容市場(主要是中國)經濟狀況疲軟的影響。

  • Despite the economic pressures that are currently impacting our Aesthetics portfolio, we remain very confident in its long-term growth outlook. In September, we began launching SkinVive in the U.S. And in the next few years, we plan to launch new indications for BOTOX in the lower face segment, and our novel fast-onset, short-duration toxin BoNT/E. In addition to our R&D programs, we have a robust Alle technology pipeline, which will bring new tech products into the U.S. market to help our customers acquire, retain and cross-sell more Aesthetics patients. Our strong leadership positions in both cosmetic toxins and facial fillers combined with the significant investments we're making to drive market acceleration will position us for strong growth going forward.

    儘管目前經濟壓力正在影響我們的美容產品組合,但我們對其長期成長前景仍充滿信心。 9月份,我們開始在美國推出SkinVive。在接下來的幾年裡,我們計劃在下面部推出BOTOX的新適應症,以及我們新型的快速起效、短持續時間的毒素BoNT/E。除了我們的研發項目之外,我們還擁有強大的 Alle 技術管道,它將把新技術產品引入美國市場,幫助我們的客戶獲得、留住和交叉銷售更多的美容患者。我們在化妝品毒素和臉部填充劑領域的強大領導地位,加上我們為推動市場加速而進行的重大投資,將為我們未來的強勁成長奠定基礎。

  • With that, I'll turn the call over to Tom.

    這樣,我就把電話轉給湯姆。

  • Thomas J. Hudson - Senior VP of Research & Development and Chief Scientific Officer

    Thomas J. Hudson - Senior VP of Research & Development and Chief Scientific Officer

  • Thank you, Carrie. In Immunology, we had 2 important milestones in the third quarter for SKYRIZI in inflammatory bowel disease. Following completion of the Phase III maintenance trial in ulcerative colitis. We submitted our regulatory applications for SKYRIZI in this indication in the U.S. and Europe with approvals anticipated in 2024. We also recently presented results from the sequence head-to-head trial comparing SKYRIZI to STELARA in patients with moderate to severe Crohn's disease. We're extremely pleased with how SKYRIZI performed in this study, which enrolled very difficult-to-treat patients who all failed anti-TNF therapy. SKYRIZI met the primary and all secondary endpoints in the trial, demonstrating clear superiority to STELARA on all endpoints at week 48 with a more than doubling of effect in endoscopic remission at 32% of SKYRIZI versus 16% for STELARA and endoscopic response at 45% versus 22% for STELARA.

    謝謝你,嘉莉。在免疫學方面,第三季 SKYRIZI 在發炎性腸道疾病方面取得了兩個重要的里程碑。潰瘍性結腸炎 III 期維持試驗完成後。我們在美國和歐洲提交了針對該適應症的SKYRIZI 監管申請,預計將於2024 年獲得批准。我們最近也公佈了在中度至重度克羅恩病患者中比較SKYRIZI 與STELARA 的序列頭對頭試驗的結果。我們對 SKYRIZI 在這項研究中的表現非常滿意,該研究招募了抗 TNF 治療均失敗的非常難以治療的患者。 SKYRIZI 達到了試驗中的主要和所有次要終點,在第48 週的所有終點上均表現出明顯優於STELARA,SKYRIZI 的內視鏡緩解效果提高了一倍多,SKYRIZI 為32%,STELARA 為16% ,內視鏡緩解為45%,而STELARA 則為45%。STELARA 為 22%。

  • Furthermore, steroid-free clinical remission was 61% for SKYRIZI versus 40% for STELARA. So these compelling head-to-head Crohn's data combined with the additional indication approval for ulcerative colitis expected next year will further position SKYRIZI as a highly effective, durable, safe and well-tolerated treatment option for patients with moderate to severe inflammatory bowel disease. We continue to make very good progress with the second wave of RINVOQ development programs as well in addition to the ongoing Phase III programs in GCA, lupus and HS, we recently began the Phase III program for RINVOQ in alopecia areata. We also recently announced positive top line results from a Phase II study for RINVOQ in vitiligo. In this study, RINVOQ met the primary and all secondary endpoints at week 24, demonstrating a significant improvement in both facial and total body vitiligo scoring measures compared to placebo.

    此外,SKYRIZI 的無類固醇臨床緩解率為 61%,而 STELARA 為 40%。因此,這些令人信服的克羅恩數據,加上預計明年獲得的潰瘍性結腸炎的額外適應症批准,將進一步將SKYRIZI 定位為中度至重度發炎性腸道疾病患者的高效、持久、安全和耐受性良好的治療選擇。我們的第二波 RINVOQ 開發計劃繼續取得非常好的進展,除了正在進行的 GCA、狼瘡和 HS 的 III 期計劃外,我們最近還開始了 RINVOQ 在斑禿領域的 III 期計劃。我們最近也宣布了 RINVOQ 治療白斑症的 II 期研究的正面頂線結果。在這項研究中,RINVOQ 在第 24 週達到了主要和所有次要終點,顯示與安慰劑相比,臉部和全身白斑症評分指標均顯著改善。

  • Importantly, these results continued to improve through week 52 of the study, illustrating RINVOQ's potential to provide significant skin repigmentation to patients suffering from vitiligo. Based on these results, we're advancing RINVOQ to Phase III in this indication with studies expected to begin soon. Moving to Oncology, where in the quarter, we received approval in Europe and Japan for epcoritamab as a monotherapy treatment for patients with relapsed or refractory DLBCL, who have received 2 or more systemic therapies. These approvals represent important regulatory milestones for EPCO, and we look forward to bringing this new subcutaneous treatment option to patients in these international markets. We also continue to make good progress with the development programs in earlier lines of DLBCL and follicular lymphoma and we look forward to providing updates on these programs as the data mature.

    重要的是,這些結果在研究的第 52 週持續改善,說明 RINVOQ 具有為白斑症患者提供顯著皮膚色素沉著的潛力。基於這些結果,我們正在將 RINVOQ 推進到該適應症的 III 期研究,預計很快就會開始。轉向腫瘤學,本季度,我們在歐洲和日本獲得了 epcoritamab 的批准,作為單一療法治療已接受 2 種或以上全身治療的複發性或難治性 DLBCL 患者。這些批准代表了 EPCO 的重要監管里程碑,我們期待為這些國際市場的患者帶來這種新的皮下治療選擇。我們也繼續在早期 DLBCL 和濾泡性淋巴瘤系列的開發項目上取得良好進展,我們期待隨著數據的成熟提供這些項目的更新。

  • In our VENCLEXTA multiple myeloma program, we recently announced top line results of a Phase III CANOVA trial evaluating VENCLEXTA plus dexamethasone compared to PomDex in relapsed/refractory patients with a t(11;14) mutation. In this study, the primary endpoint of IRCSS PFS was longer with VenDex versus PomDex but did not meet statistical significance. The VENCLEXTA combination also resulted in numerically higher response rates and longer overall survival compared to PomDex. While the differences in efficacy measures were not statistically significant, we believe the totality of the data show a benefit with the VENCLEXTA combination and we plan to discuss the results with regulatory agencies. We'll provide updates on the program as they become available.

    在我們的VENCLEXTA 多發性骨髓瘤計畫中,我們最近公佈了一項III 期CANOVA 試驗的主要結果,該試驗評估了VENCLEXTA 加地塞米鬆與PomDex 在具有t(11;14) 突變的複發/難治性患者中的比較。在這項研究中,VenDex 的 IRCSS PFS 主要終點比 PomDex 更長,但未達統計顯著性。與 PomDex 相比,VENCLEXTA 組合也帶來了更高的緩解率和更長的總存活期。雖然療效指標的差異在統計上不顯著,但我們相信所有數據都顯示了 VENCLEXTA 組合的益處,我們計劃與監管機構討論結果。我們將在該計劃可用時提供更新。

  • Behind VENCLEXTA, we have several exciting multiple myeloma programs emerging from our earlier stage pipeline. We continue to make good progress with our BCMA-CD3 bispecific ABBV-383 where we're nearing completion of the dose optimization work and are on track to begin Phase III studies in the first half of next year. At an upcoming medical meeting, we plan to present updated Phase I efficacy and safety results as well as monthly administration dose -- data. We're also making good progress with our next-generation BCL2 inhibitor, ABBV-453, which is currently in Phase I studies and we'll provide updates as the data become available. Now moving to Neuroscience, where in the quarter, we received approval for Aquipta in Europe, which is now the only oral CGRP antagonist approved in Europe for prevention of both episodic and chronic migraine.

    在 VENCLEXTA 背後,我們有幾個令人興奮的多發性骨髓瘤計畫正在從我們的早期管道中湧現。我們的 BCMA-CD3 雙特異性 ABBV-383 繼續取得良好進展,我們即將完成劑量優化工作,並有望在明年上半年開始 III 期研究。在即將召開的醫學會議上,我們計劃展示更新的 I 期療效和安全性結果以及每月給藥劑量資料。我們的下一代 BCL2 抑制劑 ABBV-453 也取得了良好進展,該藥物目前正處於 I 期研究,我們將在數據可用時提供更新。現在轉向神經科學,本季度我們在歐洲獲得了 Aquipta 的批准,它是目前歐洲唯一批准用於預防陣發性和慢性偏頭痛的口服 CGRP 拮抗劑。

  • And lastly, in our Aesthetics pipeline, we recently announced top line results from a second Phase III study evaluating BOTOX in platysma prominence, similar to results from the first Phase III study, all primary and secondary endpoints were met with BOTOX demonstrating a significant reduction in platysma prominence and vertical neckband. We anticipate a regulatory submission in the U.S. near the end of the year. In addition to indication expansion for BOTOX, we continue to advance our novel toxin pipeline. We recently announced positive top line results from 2 Phase III trials evaluating BoNT/E, our rapid onset, short-acting novel toxin in glabellar lines. BoNT/E performed very well in both studies meeting the primary and all secondary endpoints compared to placebo. BoNT/E was well tolerated and no safety concerns were identified. We're very pleased with these results, which demonstrate this toxin's rapid onset of action and short duration of effect. Patients treated with BoNT/E showed an improvement in glabellar lines as early as 8 hours following injection and a duration of effective 2 to 3 weeks.

    最後,在我們的美容產品線中,我們最近發表了第二項III 期研究的主要結果,該研究評估了BOTOX 在頸闊肌突出方面的效果,與第一項III 期研究的結果類似,所有主要和次要終點均透過BOTOX 實現,顯示肉毒桿菌顯著減少頸闊肌突出,頸帶垂直。我們預計將於年底向美國監管部門提交申請。除了擴大 BOTOX 的適應症外,我們還繼續推進我們的新型毒素管道。我們最近宣布了兩項評估 BoNT/E 的 III 期試驗的積極頂線結果,BoNT/E 是我們的快速起效、短效的眉間線新型毒素。與安慰劑相比,BoNT/E 在兩項研究中均表現良好,滿足主要和所有次要終點。 BoNT/E 耐受性良好,未發現任何安全性問題。我們對這些結果非常滿意,這表明這種毒素起效快且作用持續時間短。使用 BoNT/E 治療的患者早在註射後 8 小時就顯示出眉間紋的改善,且有效持續時間為 2 至 3 週。

  • This highly differentiated clinical profile could offer patients a novel option compared to currently available neurotoxins. We plan to complete the remaining development work over the course of the next few quarters and anticipate submitting our regulatory applications in the second half of next year. So in summary, we continue to make good progress across all stages and therapeutic areas of our pipeline, and we look forward to several more important milestones in the remainder of this year, including Phase II data for Teliso-V and second line plus advanced non-squamous non-small cell lung cancer, which has the potential to support an accelerated approval. Phase II proof-of-concept data for our anti-IL-1 alpha beta bispecific antibody, lutikizumab in hidradenitis suppurativa, and regulatory approval in Europe for ABBV-951, our novel subcutaneous levodopa/carbidopa delivery system for advanced Parkinson's disease. We also plan to submit updated 951 data in the U.S. near the end of the year. With that, I'll turn the call over to Scott.

    與目前可用的神經毒素相比,這種高度差異化的臨床特徵可以為患者提供新的選擇。我們計劃在接下來的幾個季度內完成剩餘的開發工作,並預計在明年下半年提交監管申請。總而言之,我們繼續在管道的所有階段和治療領域取得良好進展,我們期待在今年剩餘時間內實現幾個更重要的里程碑,包括 Teliso-V 和二線加先進非-鱗狀非小細胞肺癌,有可能支援加速批准。我們的抗IL-1 αβ 雙特異性抗體lutikizumab 治療化膿性汗腺炎的II 期概念驗證數據,以及ABBV-951(我們用於治療晚期帕金森氏症的新型皮下左旋多巴/卡比多巴遞送系統)在歐洲的監管批准。我們也計劃在年底前在美國提交更新的 951 資料。這樣,我會將電話轉給史考特。

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Thank you, Tom. I'm very pleased with the momentum of our business. The strong performance we are demonstrating from our ex-HUMIRA growth platform continues to support AbbVie's long-term growth outlook. Starting with our third quarter results. We reported adjusted earnings per share of $2.95, which is $0.14 above our guidance midpoint. These results include a $0.04 unfavorable impact from acquired IPR&D expense. Total net revenues were $13.9 billion, roughly $225 million ahead of our guidance and down 5.8% on an operational basis excluding a 0.2% unfavorable impact from foreign exchange. Importantly, these results reflect double-digit sales growth from our ex-HUMIRA growth platform.

    謝謝你,湯姆。我對我們業務的發展勢頭感到非常滿意。我們的前 HUMIRA 成長平台所展現的強勁業績持續支持艾伯維的長期成長前景。從我們第三季的業績開始。我們公佈的調整後每股收益為 2.95 美元,比我們的指導中位數高出 0.14 美元。這些結果包括收購的 IPR&D 費用帶來的 0.04 美元不利影響。總淨收入為 139 億美元,比我們的指引高出約 2.25 億美元,在營運基礎上下降 5.8%(不包括 0.2% 的外匯不利影響)。重要的是,這些結果反映了我們前 HUMIRA 成長平台的兩位數銷售成長。

  • The adjusted operating margin ratio was 46.7% of sales. This includes adjusted gross margin of 83.5% of sales, adjusted R&D investment of 12.4% of sales, acquired IPR&D expense of 0.5% of sales and adjusted SG&A expense of 23.9% of sales. Net interest expense was $398 million. The adjusted tax rate was 15.7%. Turning to our financial outlook. We are raising the midpoint of our full year adjusted earnings per share guidance by $0.25 and now expect adjusted earnings per share between $11.19 and $11.23.

    調整後的營業利益率為銷售額的46.7%。其中包括調整後毛利率佔銷售額的 83.5%、調整後研發投資佔銷售額的 12.4%、收購的 IPR&D 費用佔銷售額的 0.5% 以及調整後的 SG&A 費用佔銷售額的 23.9%。淨利息支出為 3.98 億美元。調整後的稅率為15.7%。轉向我們的財務前景。我們將全年調整後每股盈餘指引的中點上調 0.25 美元,目前預計調整後每股盈餘在 11.19 美元至 11.23 美元之間。

  • This guidance does not include an estimate for acquired IPR&D expense that may be incurred in the fourth quarter. We now expect total net revenues of approximately $54 billion, an increase of $600 million. At current rates, we expect foreign exchange to have a 0.5% unfavorable impact on full year sales growth. The updated revenue forecast contemplates a full year sales increase of $300 million, roughly split evenly between SKYRIZI and RINVOQ, reflecting strong uptake in IBD. The remaining $300 million of full year sales increase is primarily attributed to better-than-expected performance of international HUMIRA and RESTASIS.

    本指引不包括第四季度可能發生的收購知識產權研發費用的估計。我們現在預計總淨收入約為 540 億美元,增加 6 億美元。按照目前的匯率,我們預計外匯將對全年銷售成長產生 0.5% 的不利影響。更新後的營收預測預計全年銷售額將增加 3 億美元,大致由 SKYRIZI 和 RINVOQ 平分,反映出 IBD 的強勁成長。全年銷售額剩餘 3 億美元的成長主要歸功於國際品牌 HUMIRA 和 RESTASIS 優於預期的業績。

  • Moving to the P&L. We continue to forecast an adjusted operating margin ratio of approximately 46.5% of sales. We now expect adjusted net interest expense of roughly $1.7 billion. And we forecast our non-GAAP tax rate to be approximately 15.5%, reflecting IPR&D incurred through the third quarter. Turning to the fourth quarter. We anticipate net revenues of approximately $14 billion. At current rates, we expect foreign exchange to have a modest unfavorable impact on sales growth. We expect adjusted earnings per share between $2.87 and $2.91. This guidance does not include acquired IPR&D expense that may be incurred in the quarter. Finally, AbbVie's strong business performance continues to support our capital allocation priorities. We generated more than $16.5 billion of adjusted free cash flow which is net of approximately $1.1 billion of SKYRIZI royalty payments in the first 9 months of the year.

    轉向損益表。我們繼續預測調整後的營業利潤率約為銷售額的 46.5%。我們現在預計調整後的淨利息支出約為 17 億美元。我們預計非 GAAP 稅率約為 15.5%,反映了第三季發生的智慧財產權和研發費用。轉向第四季。我們預計淨收入約為 140 億美元。依照目前的匯率,我們預期外匯將對銷售成長產生適度的不利影響。我們預計調整後每股收益將在 2.87 美元至 2.91 美元之間。本指引不包括本季可能發生的收購知識產權與研發費用。最後,艾伯維強勁的業務表現持續支持我們的資本配置優先事項。今年前 9 個月,我們產生了超過 165 億美元的調整後自由現金流,其中扣除了約 11 億美元的 SKYRIZI 特許權使用費。

  • And our cash balance at the end of September was approximately $13.3 billion. Underscoring our confidence in AbbVie's long-term outlook, today we announced a 4.7% increase in our quarterly cash dividend, beginning with the dividend payment in February of 2024, and we remain on track to achieve by the end of this year, $34 billion of cumulative debt paydown since the Allergan transaction, maintaining a net leverage ratio around 1.8x. In closing, AbbVie has once again delivered outstanding results and our financial outlook remains very strong.

    截至 9 月底,我們的現金餘額約為 133 億美元。為了強調我們對艾伯維長期前景的信心,今天我們宣布將季度現金股息增加 4.7%,從 2024 年 2 月支付股息開始,我們仍有望在今年年底前實現 340 億美元的股息自艾爾建交易以來累計債務償還,淨槓桿率維持在1.8 倍左右。最後,艾伯維再次取得了出色的業績,我們的財務前景仍然非常強勁。

  • With that, I'll turn the call over to Liz.

    這樣,我就把電話轉給莉茲。

  • Elizabeth Shea - SVP of IR

    Elizabeth Shea - SVP of IR

  • Thanks, Scott. (Operator Instructions) Operator, we'll take the first question, please.

    謝謝,斯科特。 (接線員指示)接線員,我們將回答第一個問題。

  • Operator

    Operator

  • First question comes from Chris Shibutani with Goldman Sachs.

    第一個問題來自高盛的 Chris Shibutani。

  • Chris Shibutani - Research Analyst

    Chris Shibutani - Research Analyst

  • The 2024 earnings guidance, it seems as if you were quite confident heading in that $11 floor. As we await further details from top line and other margin structures, can you maybe identify some of the key push-pulls that actually gave you that conviction to go to above and where directionally we should be thinking about the source of further growth on the forward?

    2024 年的獲利指引,似乎你對邁向 11 美元的底線很有信心。當我們等待營收和其他利潤結構的更多細節時,您能否找出一些真正讓您有信心繼續前進的關鍵推動力,以及我們應該考慮未來進一步增長的來源的方向?

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Chris, it's Rob. I'll take that question. So since we provided that guidance in February, recall we gave a $10.70 EPS floor to really help investors model earnings regardless of whether the trough recurred in '23 or '24, we've raised growth platform sales by $1.4 billion covering Immunology, Neuroscience and Aesthetics. We're seeing the IBD indications for SKYRIZI and RINVOQ very nicely, and we continue to capture more share in their other indications, both VRAYLAR and our migraine portfolio have outperformed our share forecast and the strong recovery of BOTOX has led us to raise guidance for Aesthetics twice this year. So given the clear overperformance of the growth platform, we decided to raise the floor to $11 ex IPR&D. We hope this provides investors the view of the low end of the 2024 guidance range and also confirms that '24 will indeed be the trough year. And given that we expect to deliver a high single-digit CAGR from '24 to the end of the decade, it should allow investors to value the company with a better growth multiple.

    克里斯,這是羅布。我來回答這個問題。因此,自從我們在2 月提供這項指導以來,回想一下,我們給出了10.70 美元的每股收益下限,以真正幫助投資者建模收益,無論低谷是否在23 年或24 年再次出現,我們已將成長平台銷售額提高了14 億美元,涵蓋免疫學、神經科學和美學。我們很好地看到了SKYRIZI 和RINVOQ 的IBD 適應症,並且我們繼續在其他適應症中獲得更多份額,VRAYLAR 和我們的偏頭痛投資組合的表現都超出了我們的份額預測,而BOTOX 的強勁復甦促使我們提高了對今年美容兩次。因此,鑑於成長平台的明顯超額表現,我們決定將底價提高至 11 美元(不含 IPR&D)。我們希望這能讓投資者了解 2024 年指導範圍的低端,並確認 24 年確實將是低谷年。鑑於我們預計從 24 年到本十年末將實現高個位數的複合年增長率,這應該能讓投資者以更好的成長倍數來評估該公司。

  • Operator

    Operator

  • Our next question comes from Mohit Bansal with Wells Fargo.

    我們的下一個問題來自富國銀行的 Mohit Bansal。

  • Mohit Bansal - Senior Equity Analyst

    Mohit Bansal - Senior Equity Analyst

  • I have a question regarding Aesthetic. So it seems like you are keeping the guidance here. So the first part of the question is it seems like across the board, there is a 10% quarter-over-quarter decline on all the products. Can you help us understand what's happening sequentially? And then if you are keeping the guidance, it seems like there would be quite a bump in fourth quarter. So how should we think about that?

    我有一個關於美學的問題。所以看來你在這裡保留了指導。所以問題的第一部分是,似乎所有產品都出現了 10% 的季度環比下降。你能幫助我們理解依序發生的事嗎?如果你保持指引,第四季似乎會有相當大的成長。那我們該如何思考呢?

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Maybe I'll start -- this is Rob. I'll start with your question. So one thing to keep in mind is that we mentioned in the last call that we had some dynamics in the international market when you look at the growth rates where we had more difficult comparison because of some of the -- some stocking that occurred in the prior year, is that something to keep in mind. We also do have a certain amount of seasonality that occurs in our business in the U.S. in particular. So those are things to keep in mind. I'd say as we look at it, we're very encouraged by the return to growth of the U.S. toxin market.

    也許我會開始——這是羅布。我將從你的問題開始。因此,要記住的一件事是,我們在上次電話會議中提到,當您查看成長率時,我們在國際市場上有一些動態,我們很難進行比較,因為一些庫存發生在前一年,這是值得記住的事。我們的業務也確實存在一定的季節性,尤其是在美國。所以這些都是需要記住的事情。我想說,當我們看到它時,我們對美國毒素市場的恢復成長感到非常鼓舞。

  • BOTOX is performing very well, and we're certainly doing a very nice job maintaining our share position despite competitive pressure. So I'd say we're very pleased there. I'd say on pillars, what we're seeing is probably more of a lag in the recovery. And if we've studied this market historically, we do tend to see a lag and that's really relative to thinking about the price point for fillers versus toxins, it's natural to assume that the recovery will take a little bit longer. So we are seeing that recovery take a little bit longer. We're still very, very encouraged by the trends we're seeing. We're very excited about the new fillers we've launched, both SkinVive and VOLUX. We're starting to see some nice share momentum come from those new introductions. And so from that standpoint, we feel very good. And then as we've been monitoring the situation in China, as all of you I'm sure have been watching very carefully.

    BOTOX 的表現非常出色,儘管存在競爭壓力,但我們在維持市場佔有率方面確實做得非常出色。所以我想說我們對此非常滿意。我想說的是,我們看到的可能更多的是復甦的滯後。如果我們從歷史上研究這個市場,我們確實傾向於看到滯後,這確實與考慮填充劑與毒素的價格點有關,自然假設復甦將需要更長的時間。所以我們看到恢復需要更長的時間。我們仍然對我們所看到的趨勢感到非常非常鼓舞。我們對推出的新填充劑 SkinVive 和 VOLUX 感到非常興奮。我們開始看到這些新產品帶來了一些不錯的份額動力。所以從這個角度來看,我們感覺非常好。然後,當我們一直在監視中國的局勢時,我相信你們所有人都在非常仔細地觀察。

  • We saw, as you recall, a very strong recovery in the first half of the year. We've seen it moderate, and we're keeping a close eye on that. And so that's something we're obviously paying a lot of attention to. Now we look at the rest of the international business, it's growing nicely. And so as I think about the guidance for this year, I'd say we're fairly close. We're not overly concerned. We don't adjust guidance for plus or minus $100 million. If it was greater than that, we would consider it. So that's something to keep in mind. But as we look at this, the long-term outlook for this business, we're very confident. When you think about the U.S. toxin market, it's historically grown in the mid-teens and it's still heavily underpenetrated in the low single digits.

    正如您所記得的那樣,我們在今年上半年看到了非常強勁的復甦。我們已經看到它的溫和,我們正在密切關注這一點。這顯然是我們非常關注的事情。現在我們來看看其他的國際業務,它成長得很好。因此,當我思考今年的指導時,我想說我們已經相當接近了。我們並不過度擔心。我們不會將指導值調整為正負 1 億美元。如果大於這個值,我們就會考慮。所以這是需要記住的事情。但當我們看到這個業務的長期前景時,我們非常有信心。想想美國的毒素市場,它的歷史成長速度是十幾歲左右,但滲透率仍然嚴重不足,只有個位數。

  • And market growth is really the key to deliver on our long-term outlook. We've seen this market rebound very strongly following a period of economic pressure, and we've demonstrated time and again that we can increase new patient starts for our promotional efforts. And something I think probably isn't appreciated is that we do have several innovations that can accelerate that growth. And when you think about the master and platysma indications for BOTOX, those can each add a few hundred million dollars. Our novel short-acting toxin BoNT/E has the potential to activate new patients that could really drive an inflection in market growth. As you think about one of the biggest barriers for new patients is fear of an unnatural look, and the short-acting toxin opportunity is a great way to unlock that. And then if you look at our regenerative fillers pipeline, those are aimed at providing both short- and long-term treatment benefits for consumers.

    市場成長確實是實現我們長期前景的關鍵。我們看到這個市場在經歷一段時期的經濟壓力後出現了非常強勁的反彈,並且我們已經一次又一次地證明我們可以透過我們的促銷活動增加新的患者開始數量。我認為可能沒有被重視的是,我們確實有一些可以加速這種成長的創新。當你考慮到 BOTOX 的主適應症和頸闊肌適應症時,這些適應症都可以增加數億美元。我們的新型短效毒素 BoNT/E 有潛力激活新患者,從而真正推動市場成長。當你想到新患者最大的障礙之一是害怕不自然的外觀時,短效毒素機會是解決這個問題的好方法。然後,如果您查看我們的再生填充劑管道,您會發現這些管道旨在為消費者提供短期和長期的治療益處。

  • And as I mentioned, we're also very excited about the new fillers we've launched both SkinVive and VOLUX. So with this business, you see us go through some cycles with economic pressure. But over the long term, we feel very confident that we can certainly deliver very robust growth and deliver on that real than $9 billion expectation for 2029.

    正如我所提到的,我們也對推出 SkinVive 和 VOLUX 的新填充劑感到非常興奮。因此,在這項業務中,您會看到我們經歷了一些經濟壓力的週期。但從長遠來看,我們非常有信心,我們一定能夠實現非常強勁的成長,並實現 2029 年超過 90 億美元的實際預期。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Mohit, this is Rick. The other thing that you're looking at sequentially, you have to keep in mind is we do BOTOX today in the fourth quarter. So that elevates revenue in the fourth quarter, and that occurs every year. So if you're looking at third quarter to fourth quarter and trying to understand why is there a big step up, part of that step-up is that.

    莫希特,這是瑞克。您必須記住的另一件事是我們今天在第四季度進行了肉毒桿菌治療。因此,這會增加第四季度的收入,而且這種情況每年都會發生。因此,如果您正在研究第三季到第四季並試圖理解為什麼會出現重大進步,那麼進步的一部分就是這樣的。

  • Operator

    Operator

  • Our next question comes from Chris Schott with JPMorgan.

    我們的下一個問題來自摩根大通的克里斯·肖特。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Just maybe a 2-parter really focused on Immunology for 2024. So maybe first on SKYRIZI and RINVOQ, I guess, with more of the '24 formulary discussions complete, we're seeing some great volume trends. But are you still comfortable that we should expect more normalized price erosion for those 2 products versus the high single digits we're seeing this year? And then the second one was on HUMIRA for 2024. And I think, Rob, you might have commented last quarter of your comfort with where consensus sits. And again, maybe a similar question with maybe more color about formulary for next year. Is that something you're still comfortable? And just how should we think about dynamics there?

    也許一個 2 人真正專注於 2024 年的免疫學。因此,我想,也許首先是 SKYRIZI 和 RINVOQ,隨著更多 24 年處方討論的完成,我們看到了一些巨大的銷售趨勢。但是,與今年我們看到的高個位數價格相比,我們應該預期這兩種產品的價格會出現更正常化的侵蝕,您是否仍然感到滿意?然後第二個是 2024 年的 HUMIRA。我想,Rob,你可能在上個季度對共識的位置發表了評論。再說一遍,也許是一個類似的問題,可能對明年的處方集有更多的色彩。那是你仍然感到舒服的事情嗎?我們該如何思考那裡的動態?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. It's Jeff. I'll take the first question. Yes, we're very comfortable as we see things start to evolve and close here as we move into 2024. I mean if you think about all the indications that we've had, 7, over the last 18 months, I highlighted in my remarks, 9 head-to-head trials. We're just in a very, very nice position for SKYRIZI and RINVOQ as we move into '24 to continue some very strong momentum that we're seeing in the actual. So quite confident in terms of how we're looking at that. And to your key point there on the price, we continue to see that we're not going to have a repeat of what we saw this year. And remember, the background there were those 7 indications that came very fast all on top of each other. And so that was the root cause of that -- of those concessions that won't repeat. Next year, we have really 1 more big indication, not 7, and that's SKYRIZI you see that Tom highlighted. So we'll see the normalized price erosion more in line with industry norms versus what we saw this year.

    是的。是傑夫。我來回答第一個問題。是的,當我們看到事情開始發展並在進入2024 年時結束時,我們感到非常舒服。我的意思是,如果你考慮一下我們在過去18 個月裡7 所發現的所有跡象,我在我的報告中強調了這一點。備註,9次正面交鋒。當我們進入 24 年時,我們對 SKYRIZI 和 RINVOQ 來說處於一個非常非常好的位置,以繼續我們在實際中看到的非常強勁的勢頭。對於我們如何看待這個問題非常有信心。關於價格的關鍵點,我們繼續看到今年的情況不會重演。請記住,背景中有 7 個跡象,它們的出現速度非常快,而且相互疊加。所以這就是那些不會重複的讓步的根本原因。明年,我們確實還有 1 個重大跡象,而不是 7 個,這就是 Tom 強調的 SKYRIZI。因此,與今年的情況相比,我們將看到正常化的價格侵蝕更符合產業規範。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • And then, Chris, this is Rob. On HUMIRA, I think if you think about the annualization rebates that given the (inaudible) increase in the second half of this year, so you have an annualization impact, and the additional rebates to secure parity access next year, really price should be the main driver of the erosion in '24. I mean volume will have an impact, particularly in wax sensitive accounts, but price will make up the vast majority of the erosion next year. And while we're not giving '24 guidance today, as you've mentioned, Chris, I've highlighted the average, it was about $7 billion when I mentioned that was a reasonable expectation for U.S. HUMIRA next year. Now there are a few analysts who have forecasted U.S. HUMIRA above $8 billion next year, which is just not a reasonable expectation given the price dynamic.

    然後,克里斯,這是羅布。關於 HUMIRA,我認為,如果你考慮到今年下半年(聽不清楚)成長的年化回扣,那麼你會產生年化影響,以及確保明年平價訪問的額外回扣,真正的價格應該是24 年侵蝕的主要驅動力。我的意思是數量會產生影響,特別是在對蠟敏感的帳戶中,但明年價格將彌補絕大多數的侵蝕。雖然我們今天沒有給出 24 小時指導,但正如你所提到的,克里斯,我強調了平均值,當我提到這是明年美國 HUMIRA 的合理預期時,該平均值約為 70 億美元。現在有一些分析師預測美國 HUMIRA 明年的銷售額將超過 80 億美元,考慮到價格動態,這並不是合理的預期。

  • Operator

    Operator

  • Next question comes from Terence Flynn with Morgan Stanley.

    下一個問題來自摩根士丹利的特倫斯·弗林。

  • Terence C. Flynn - Equity Analyst

    Terence C. Flynn - Equity Analyst

  • Obviously, you guys are very well positioned coming out of the HUMIRA LOE in terms of the growth franchise. But I think there's focus from investors on maybe bolstering the pipeline. So as you guys think about M&A and business development, maybe you could just walk us through your latest thoughts and anything in terms of therapeutic areas of interest and stage of development.

    顯然,從 HUMIRA LOE 出來的你們在成長方面處於非常有利的位置。但我認為投資者的注意力可能集中在加強管道上。因此,當您考慮併購和業務發展時,也許您可以向我們介紹您的最新想法以及有關感興趣的治療領域和發展階段的任何資訊。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Okay. Terence, this is Rick. I'll cover that question for you. Yes, I think as we look at the business, as Rob indicated, we're extremely comfortable with how the growth platform is performing. And I'd say how we're managing the biosimilar erosion, which gives us a lot of confidence that we can deliver this high single-digit going forward -- from '25 and going forward through the end of the decade. So I'd say the bulk of what we're looking at, and we're in a fortunate position from that standpoint. There are many companies in our sector we need to go out and do lots of BD to be able to drive the growth that they're trying to achieve. We're not in that position. But I'd say the bulk of what we're looking at is we're looking to add assets that could give us incremental pipeline and revenue growth towards the end of this decade and into the '30s. That's what our -- the bulk of our focus is on.

    好的。特倫斯,這是瑞克。我會為你解答這個問題。是的,我認為,正如羅布所指出的那樣,當我們審視業務時,我們對成長平台的表現感到非常滿意。我想說的是我們如何管理生物相似藥的侵蝕,這給了我們很大的信心,我們可以在未來實現這一高個位數的增長——從 25 年開始一直到本世紀末。所以我想說的是我們正在關注的大部分內容,從這個角度來看,我們處於一個幸運的位置。我們行業中有很多公司,我們需要走出去,做大量的業務發展,才能推動他們想要實現的成長。我們不處於那個位置。但我想說的是,我們關注的大部分內容是我們希望增加資產,這些資產可以在本世紀末和 30 年代為我們帶來增量管道和收入成長。這就是我們的重點。

  • And I'd say if I look at AbbVie's track record, certainly, BD has been a critical part of how we've grown this company over the last 11 years. And I'd say, for the most part, we have done a pretty good job when we acquire assets and bring them in, we can make them perform quite well. SKYRIZI is a good example of that. Certainly, Allergan was another good example of that, and there are many others. So I'd say we value BD as a very important tool and how we should grow the business and how we should position our leadership positions in these franchises. Our primary focus is within the franchises that we're operating in. So let's take immunology as an example.

    我想說,如果我看看艾伯維 (AbbVie) 的業績記錄,毫無疑問,BD 一直是我們在過去 11 年裡發展這家公司的關鍵部分。我想說,在很大程度上,當我們收購資產並引進它們時,我們做得相當不錯,我們可以讓它們表現得很好。 SKYRIZI 就是一個很好的例子。當然,艾爾建(Allergan)是另一個很好的例子,還有很多其他例子。所以我想說,我們將 BD 視為一個非常重要的工具,以及我們應該如何發展業務以及我們應該如何在這些特許經營中定位我們的領導地位。我們的主要關注點是我們正在經營的特許經營範圍內。所以讓我們以免疫學為例。

  • I would say our greatest focus in immunology is to continue to add additional mechanisms in particular, that could be used in combination in order to create deeper levels of clinical response in areas like IBD, rheumatology and other areas. So we continue to look for those. We have several already that are in development now, like (inaudible), like RIPK1 and several others in our pipeline, but we'll continue to look for additional assets that we could add to that. And like I said, especially focused on combination therapy because we think that is the way to get much deeper clinical remission or responses in those patients who aren't responding to things like SKYRIZI and RINVOQ, which obviously performed exceptionally well.

    我想說,我們在免疫學方面最大的重點是繼續添加額外的機制,特別是可以組合使用的機制,以便在 IBD、風濕病學和其他領域產生更深層的臨床反應。所以我們繼續尋找那些。我們現在已經有幾個正在開發中,例如(聽不清楚)、RIPK1 和我們管道中的其他幾個,但我們將繼續尋找可以添加到其中的其他資產。正如我所說,特別關注聯合治療,因為我們認為這是使那些對 SKYRIZI 和 RINVOQ 等藥物沒有反應的患者獲得更深入的臨床緩解或緩解的方法,而 SKYRIZI 和 RINVOQ 顯然表現得非常好。

  • So that's a big area. Oncology is another big area. We have a high level of interest in next-generation CAR T technology. We have a high level of interest in T-cell engagers beyond our BCMA product. I think as we look at that asset continue to develop, we are very convinced it has a best-in-class profile. And it shows us that for the right indication, T-cell engagers can be extremely effective, and they're much easier to use and can be much more broadly brought to patients and CAR Ts, at least the current version of CAR T. So I'd say that's an area that we have a high level of interest. In Psychiatry, we're interested in additional assets in anxiety and mood, and a variety of other assets, but that gives you some feel for it. And we obviously have the financial wherewithal to go out and do transactions. We need to make sure we find the right transaction. So it's a value-enhancing asset for the company. And when we find them, we will act on and we will act on quickly.

    所以這是一個很大的區域。腫瘤學是另一個大領域。我們對下一代 CAR T 技術非常感興趣。除了我們的 BCMA 產品之外,我們對 T 細胞參與者也非常感興趣。我認為,當我們看到該資產的持續發展時,我們非常確信它擁有一流的配置。它向我們表明,對於正確的適應症,T 細胞接合器可以非常有效,而且它們更容易使用,並且可以更廣泛地應用於患者和 CAR T,至少是當前版本的 CAR T。我想說這是我們非常感興趣的領域。在精神病學中,我們對焦慮和情緒方面的其他資產以及各種其他資產感興趣,但這會給你一些感覺。我們顯然有足夠的財力出去進行交易。我們需要確保找到正確的交易。因此,它對公司來說是一項增值資產。當我們找到它們時,我們將採取行動,而且我們將迅速採取行動。

  • Operator

    Operator

  • Next question comes from Tim Anderson with Wolfe Research.

    下一個問題來自沃爾夫研究公司的提姆·安德森。

  • Alice Jennifer Nettleton - Research Analyst

    Alice Jennifer Nettleton - Research Analyst

  • This is Alice Nettleton on for Tim Anderson. A question on obesity and its interface with INI and a lot of other drug categories, frankly, (inaudible) that payers have to cover obesity medicines. And if that's correct, it's a big expense, and payers will be looking for offsets. One-off that would be for payers to squeeze other therapeutic areas as hard as they can. An example could be INI, where there's now a really good product, your own HUMIRA at a much lower price. So we're wondering how much payers might start to force a step edit for products like SKYRIZI. It's a relevant question because yesterday, one of the issues Bristol noted with its (inaudible) product is step edits and they cite biosimilar HUMIRA as the reason.

    我是愛麗絲·內特爾頓 (Alice Nettleton) 替蒂姆·安德森 (Tim Anderson) 發言。關於肥胖及其與 INI 和許多其他藥物類別的相互作用的問題,坦白說,(聽不清楚)付款人必須支付肥胖藥物的費用。如果這是正確的,這將是一筆巨大的開支,付款人將尋求補償。其中之一就是付款人會盡可能擠壓其他治療領域。一個例子是 INI,現在有一個非常好的產品,您自己的 HUMIRA,價格低得多。因此,我們想知道有多少付款人可能會開始強制對 SKYRIZI 這樣的產品進行步驟編輯。這是一個相關的問題,因為昨天,布里斯托爾注意到其(聽不清楚)產品的問題之一是步驟編輯,他們引用了生物相似藥 HUMIRA 作為原因。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Thank you for the question. It's Jeff. And I think you've got to take a step back regardless of the obesity issues and think about the overall strategy that we pursued, which was one of fundamental distinction. And I'll take your point over some of these head-to-head trials, and there's 9 of them, right? So if you take SKYRIZI, just in psoriasis, we have gross superiority versus every mechanism in the category. So a head-to-head of gross superiority versus HUMIRA versus the leading IL-17 Cosentyx versus the oral Otezla, and we also have versus STELARA. So fundamentally, when payers think about stepping or not stepping or how they would think about that, there's a medical dynamic there and that distinctiveness that we have across our program is very, very important to help manage maybe the urge of the payers to think of formulary structures like that. If you think about your comments that you have -- that you heard yesterday or the day before, that's a very different dynamic.

    感謝你的提問。是傑夫。我認為,無論肥胖問題如何,你都必須退後一步,思考我們所追求的整體策略,這是根本區別之一。我將透過其中一些面對面的試驗來闡述您的觀點,其中有 9 個,對吧?因此,如果您服用 SKYRIZI,僅在牛皮癬方面,我們相對於該類別中的每種機制都具有明顯的優勢。因此,與 HUMIRA 相比,與領先的 IL-17 Cosentyx 相比,與口服 Otezla 相比,我們也與 STELARA 相比,具有明顯的優勢。因此,從根本上說,當付款人考慮是否繼續付款或他們會如何考慮時,就會存在一種醫學動態,而我們整個計劃的獨特性對於幫助管理付款人考慮的衝動非常非常重要像這樣的公式結構。如果你想想你昨天或前天聽到的評論,那就是一個非常不同的動態。

  • I mean, if you're not that different or you have the same efficacy as a HUMIRA, it's not going to go that well on some of these formularies. And so I think you got to take a step back and look at the fundamental distinctiveness that we have on both SKYRIZI and RINVOQ. And I think my last comment would be, let's take RINVOQ, which is growing very fast, 60%, okay? All of that is in the second-line plus setting. So from a strategic standpoint, it's already stepped. And so when you take a look at those dynamics, we remain quite confident that as we rely on the power of raising the standard of care, that will help us navigate any of these scenarios, whether it's related to obesity or not.

    我的意思是,如果您沒有那麼不同,或者您與 HUMIRA 具有相同的功效,那麼其中一些處方藥的效果就不會那麼好。因此,我認為您必須退後一步,看看我們 SKYRIZI 和 RINVOQ 的基本獨特性。我想我最後的評論是,讓我們以 RINVOQ 為例,它增長非常快,增長了 60%,好嗎?所有這些都在二線加設定中。所以從戰略的角度來看,它已經邁出了一步。因此,當你看到這些動態時,我們仍然非常有信心,因為我們依靠提高護理標準的力量,這將幫助我們應對任何這些情況,無論它是否與肥胖有關。

  • Operator

    Operator

  • Next question comes from Vamil Divan with Guggenheim Securities.

    下一個問題來自古根漢證券公司的瓦米爾·迪萬。

  • Vamil Kishore Divan - Research Analyst

    Vamil Kishore Divan - Research Analyst

  • I hope you can hear me. I'm in transit right now. But the 2 questions I have actually, one is maybe building on Terence's question around business development base in the pipeline. I think we get a lot of other questions just around sort of the underappreciated assets within your pipeline. I don't know if you can maybe just comment on that. I know there's a couple of assets that you pointed out, do you think people are overlooking where they might be some underappreciated upside? And then the second one is just on the charge you took today or this quarter on IMBRUVICA regarding the Medicare drug pricing program.

    我希望你能聽到我的聲音。我現在正在過境。但我實際上有兩個問題,其中一個可能是建立在特倫斯關於管道中的業務發展基礎的問題之上的。我認為我們也收到了很多關於您的管道中未被充分重視的資產的其他問題。我不知道你是否可以對此發表評論。我知道您指出了一些資產,您認為人們是否忽略了它們可能被低估的優勢?第二個是您今天或本季在 IMBRUVICA 上收取的有關 Medicare 藥品定價計劃的費用。

  • And obviously, I understand why you did. I'm curious on the amount and the timing of why you're doing now, I suppose I may be willing to see how the losses play out or the negotiation process plays out. And then in terms of the amount or how you -- what your assumptions were that you can share on the competitive dynamics for sort of what you're assuming around the impact of this program would have on the pricing of (inaudible) charge.

    顯然,我明白你為什麼這麼做。我很好奇你現在這樣做的金額和時間,我想我可能願意看看損失的結果或談判過程如何進行。然後就金額或如何 - 您的假設是,您可以分享競爭動態,以及您對該計劃對(聽不清楚)費用定價的影響的假設。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Divan, this is Rick. I'll take the first question, and then Scott will take the second question. So on the pipeline, I think as I look at the pipeline and how we built the pipeline and how it's playing out, I think -- I don't know that I would call it underappreciated because you don't necessarily have access to all the data that we have on some of these programs. But we obviously invested significantly over the last several years in rapidly developing the indications for RINVOQ and SKYRIZI and a lot of our focus had been built around that. But in parallel, we were advancing a number of other programs along the way.

    迪萬,這是瑞克。我將回答第一個問題,然後斯科特將回答第二個問題。因此,在管道方面,我認為當我查看管道以及我們如何構建管道以及它如何發揮作用時,我認為- 我不知道我會稱其為“未被充分重視”,因為你不一定有權訪問所有內容我們擁有的其中一些項目的數據。但顯然,我們在過去幾年中投入了大量資金來快速開發 RINVOQ 和 SKYRIZI 的適應症,並且我們的許多重點都是圍繞這一點建立的。但同時,我們也在推動許多其他項目。

  • And I would say the investment that we made on SKYRIZI and RINVOQ are pretty clear kind of return that we are getting for those assets. I mean, they're growing at a phenomenal rate. In fact, in the not-too-distant future, the combination of those 2 products on a running rate basis will be larger than HUMIRA, to give you some idea of how rapidly those products are growing and how large they are. But if I look at our pipeline, the real meaningful programs that we have in our pipeline that will be true needle movers for the company. There are several of them that are advancing now that I think we have a high level of confidence in 400, our (inaudible) platform, with our c-Met version of that.

    我想說的是,我們對 SKYRIZI 和 RINVOQ 的投資是我們從這些資產中獲得的非常明顯的回報。我的意思是,它們正在以驚人的速度成長。事實上,在不久的將來,這兩種產品的運行率組合將比 HUMIRA 更大,讓您了解這些產品的成長速度和規模。但如果我看看我們的管道,我們管道中真正有意義的專案將成為公司真正的推動者。現在其中有幾個正在取得進展,我認為我們對 400、我們的(聽不清楚)平台以及我們的 c-Met 版本充滿信心。

  • We're seeing very encouraging data in CRC. We'll follow that with non-small cell lung cancer. And that platform is demonstrating to us that it is a broad-based platform that we can expand to a number of other areas. And that should be a fairly significant opportunity for us going forward. Later sort of the '27, '28 kinds of time frame, I think, is when we'll have meaningful benefit play through. And then I'd say the second one is 383, our BCMA bispecific. As we indicated earlier, we're seeing more and more data out of that program that clearly tells us this has a best-in-class profile, high levels of efficacy and very good safety and very convenient dosing.

    我們在 CRC 中看到了非常令人鼓舞的數據。我們將關注非小細胞肺癌。該平台向我們表明,它是一個基礎廣泛的平台,我們可以擴展到許多其他領域。這對我們前進來說應該是一個相當重要的機會。我認為,稍後的「27」、「28」時間框架是我們將獲得有意義的利益的時候。然後我想說第二個是 383,我們的 BCMA 雙特異性抗體。正如我們之前指出的,我們從該計劃中看到越來越多的數據,這些數據清楚地告訴我們,該計劃具有一流的性能、高水平的功效、非常好的安全性和非常方便的劑量。

  • We think it has that ideal profile to be able to enter this market. And as you know, multiple myeloma is a very large market. There are very significant products in this market. So those are 2 opportunities. I would obviously say, 916. And some of our TAL programs are also exciting programs that are running in parallel to these. We'll be getting more data on those next year. And I think those have significant opportunities as well. The third program I talked about is in our eye care business. It's our REGENXBIO program for both wet AMD and diabetic retinopathy. We're seeing some very, very encouraging data out of that program, and that could be a nice opportunity for us as well, and it continues to advance well. So there are a number of important programs that you'll start to see more and more data as we go through '24 and into '25 that I think will give the market an opportunity to be able to better assess those.

    我們認為它具有能夠進入這個市場的理想形象。如您所知,多發性骨髓瘤是一個非常大的市場。這個市場上有非常重要的產品。所以這是兩個機會。我顯然會說,916。我們的一些 TAL 專案也是與這些專案並行運行的令人興奮的專案。明年我們將獲得更多相關數據。我認為這些也有重要的機會。我談到的第三個項目是我們的眼保健業務。這是我們針對濕性 AMD 和糖尿病視網膜病變的 REGENXBIO 計畫。我們從該計劃中看到了一些非常非常令人鼓舞的數據,這對我們來說也可能是一個很好的機會,並且它繼續取得良好進展。因此,隨著我們進入 24 世紀和 25 世紀,您將開始看到許多重要計劃的數據,我認為這將使市場有機會更好地評估這些數據。

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Vamil, this is Scott. With respect to your question on the IMBRUVICA charge. So I think a couple of things. As we have signaled in some of our regulatory filings, our last 10-Q, for instance, we had indicated that if we were -- IMBRUVICA were to be selected in the negotiation process under the Inflation Reduction Act, that there would likely trigger an impairment. And so we had anticipated that this would be happening. So the timing really relates to the fact that under the rules, you have to look at the fair value of that intangible asset with respect to future cash flows. And so the accounting rules would require that we would make that analysis upon selection as we had kind of previewed in our filings. And so we went through the process under that triggering event to determine what the impairment should be.

    瓦米爾,這是史考特。關於您關於 IMBRUVICA 費用的問題。所以我想有幾件事。正如我們在一些監管文件中所表明的那樣,例如,我們在最近的 10-Q 報告中表示,如果我們 - IMBRUVICA 在《通貨膨脹減少法案》的談判過程中被選中,那麼可能會引發損害。所以我們預料到會發生這種情況。因此,時機確實與以下事實有關:根據規則,您必須考慮該無形資產相對於未來現金流量的公允價值。因此,會計規則要求我們在選擇時進行分析,就像我們在文件中預覽的那樣。因此,我們在該觸發事件下完成了整個過程,以確定損害應該是什麼。

  • And I would say that when you look at that impairment, the magnitude of the impairment is driven by a number of factors, but really one of the biggest factors that you're seeing there is it requires you to discount the future cash flow. So as we calculate the future cash flows, looked at what we had assumed was a reasonable assumption on the price, we discount those back. And so that creates part of the magnitude of this adjustment. In terms of the negotiated price that we assumed, I think we're in the middle of these negotiations, and it really wouldn't be appropriate for us to talk about what that is. But we looked at a number of factors, and we think that process is going to play out. Certainly, we will see on February 1 in a private conversation with CMS what they anticipate at least an initial thought on price, but it won't be finalized until September 1 of next year. And so we will see what that price is as the process plays out.

    我想說,當你考慮減損時,減損的程度是由許多因素驅動的,但實際上你看到的最大因素之一是它要求你對未來現金流進行折現。因此,當我們計算未來現金流量時,看看我們所假設的合理價格假設,我們會對其進行折現。因此,這造成了這次調整的部分幅度。就我們假設的協商價格而言,我認為我們正處於這些談判的中間,我們確實不適合談論它是什麼。但我們考慮了許多因素,我們認為這個過程將會結束。當然,我們將在 2 月 1 日與 CMS 進行私下對話時看到他們預計至少對價格的初步想法,但要到明年 9 月 1 日才能最終確定。因此,隨著流程的展開,我們將看到這個價格是多少。

  • Operator

    Operator

  • Our next question comes from Steve Scala with TD Cowen.

    我們的下一個問題來自 Steve Scala 和 TD Cowen。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I have 2 questions and 1 clarification. First, a clarification. Is the base year for the high single-digit revenue growth to the end of the decade is the base year 2023 -- or excuse me, 2024 or 2025? I think it's '25, but maybe you can clarify that. Second, given AbbVie's stated interest in building the Oncology business, I assume that AbbVie took a hard look at the ADC deal that Merck signed with Daiichi. I'm just curious what about it didn't you like? Was it the profile of the products? Was it the price? Or do you feel you have everything you need already? And then the last question is at least one other company has changed its tax rate guidance stemming from a recent IRS document clarifying Section 174 tax legislation. Do you have any perspective on this update and why it doesn't impact AbbVie?

    我有 2 個問題和 1 個澄清。首先,澄清一下。到本十年結束時實現高個位數收入成長的基準年是 2023 年,還是 2024 年或 2025 年?我認為現在是 25 年,但也許你可以澄清一下。其次,考慮到艾伯維表示有興趣建立腫瘤業務,我認為艾伯維認真考慮了默克與 Daiichi 簽署的 ADC 協議。我只是好奇你不喜歡什麼?是產品的簡介嗎?是價格嗎?或者你覺得你已經擁有你需要的一切了嗎?最後一個問題是,至少還有一家公司根據最近的 IRS 文件澄清了第 174 條稅收立法而改變了其稅率指引。您對此更新有何看法以及為什麼它不會影響艾伯維?

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Steve, this is Rob. I'll take your first question. So the base year is '24. And if you think about it, we signaled that we expect to return a robust growth in '25. And so that high single-digit CAGR really would pick up that first year of robust growth of 25%. If you start in '25, you miss that year of growth. So our intention has always been '24 is a base year and that high single-digit CAGR starts from '24 to the end of the decade.

    史蒂夫,這是羅布。我來回答你的第一個問題。所以基準年是'24。如果你仔細想想,我們曾表示我們預計將在 25 年實現強勁成長。因此,高單位數複合年增長率確實會帶來第一年 25% 的強勁成長。如果你從 25 世紀開始,你就會錯過那一年的成長。因此,我們的意圖始終是「24 年是一個基準年,高單位數複合年增長率從 24 年開始到本十年末」。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Steve, this is Rick. I'll take the second question. Obviously, I'm not going to comment on whether we looked at that same transaction and that probably wouldn't be appropriate. But what I can tell you is we knew it was there. So maybe that gives you some idea of our perspective on it. But the reality is, we believe we have what we need with 400. We believe that platform, and we own that platform, we developed it internally. We give us everything that we need in that area. And so it wasn't something that we were looking at. Scott?

    史蒂夫,這是瑞克。我來回答第二個問題。顯然,我不會評論我們是否查看了同一筆交易,這可能是不合適的。但我可以告訴你的是我們知道它就在那裡。也許這能讓您了解我們對此的看法。但現實是,我們相信 400 已經滿足了我們的需求。我們相信這個平台,並且我們擁有這個平台,我們在內部開發了它。我們為我們提供該領域所需的一切。所以這不是我們正在考慮的事情。史考特?

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Yes. It's Scott. So with respect to the tax legislation, I certainly -- when I can talk about what our facts are. But when we've looked at -- certainly, this results out of tax reform legislation a few years ago. The tax rules, there's always a little bit of uncertainty. And what happened this quarter, there was guidance that came out that, I would say, clarified a certain approach in treatment. Prior to that guidance, though, there was a little bit of a diversity of opinion amongst advisers as to -- and ourselves as to how we might implement. So I would tell you that we were already implementing consistent with how that guidance ultimately came out, and that's why you're not seeing any impact to us on our tax rate.

    是的。這是斯科特。因此,關於稅收立法,我當然會——當我可以談論我們的事實時。但當我們看到——當然,這是幾年前稅改立法的結果。稅收規則總是存在一些不確定性。本季發生的事情,我想說的是,出現了指導,澄清了某種治療方法。然而,在該指導之前,顧問和我們自己對於如何實施存在一些不同的意見。因此,我想告訴您,我們已經按照該指導意見的最終結果進行了實施,這就是為什麼您沒有看到我們的稅率受到任何影響。

  • Operator

    Operator

  • The next question comes from Gary Nachman with Raymond James.

    下一個問題來自加里·納赫曼和雷蒙德·詹姆斯。

  • Gary Jay Nachman - MD & Senior Life Sciences Analyst

    Gary Jay Nachman - MD & Senior Life Sciences Analyst

  • So first, back to the trough raise in 2024. How are you thinking about spending levels for both SG&A and R&D into the trough year next year to set up for growth in '25 and beyond. And do you have a better sense of where the operating margin might end up next year? And then secondly, SKYRIZI and RINVOQ have been doing very well in the IBD indications, talk about how much headroom you see for those products in UC and Crohn's with that landscape likely getting more competitive in the coming years? And any updated thoughts on 2025 guidance for those products?

    首先,回到 2024 年的低谷成長。您如何考慮明年低谷年度的 SG&A 和研發支出水平,以便為 25 年及以後的成長做好準備。您是否對明年的營業利潤率可能會達到什麼水準有更好的了解?其次,SKYRIZI 和 RINVOQ 在 IBD 適應症方面表現非常好,談談您認為這些產品在 UC 和克羅恩病領域的發展空間有多大,未來幾年該領域可能會變得更具競爭力?對於這些產品的 2025 年指南有何最新想法?

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Gary, it's Scott. I'll start with your question regarding operating margin. So when we've looked at the operating margins we talked about in the past, for '23 and '24, we talked about those being very, very similar. So when you think about the operating margin that we've talked about for this year and next year, it's really about 46% to 47% range. This year, our guidance is 46.5% and we would expect operating margin in '24 to be very similar to what we're seeing this year. And then I think as a result, roughly the gross margin is going to be in line in '24 with what we're seeing this year as well as the expense profile. So very consistent with this year. And of course, we'll refine that when we come out with guidance.

    加里,這是斯科特。我將從你關於營業利潤率的問題開始。因此,當我們查看過去討論過的 23 年和 24 年的營業利潤率時,我們發現它們非常非常相似。因此,當你考慮我們今年和明年討論的營業利潤率時,你會發現它實際上在 46% 到 47% 的範圍內。今年,我們的指導值為 46.5%,我們預計 24 年的營業利潤率將與今年的情況非常相似。然後我認為,24 年的毛利率大致將與我們今年看到的情況以及費用狀況保持一致。所以與今年非常一致。當然,當我們推出指導時,我們會對其進行完善。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. This is Jeff. I'll highlight the -- your comment on the head space and IBD. I mean the IBD market is very, very attractive. If we think back historically, we were always, frankly, a little surprised at how fast HUMIRA back in the day grew when we started to achieve the UC and the Crohn's indications. And again, I would say we're very, very pleasantly encouraged about the momentum. The momentum is very, very significant. So there is significant headroom. And what we see in the market dynamic is that unlike what you might think that patients would always want to rotate off of their medications because of the severity of the disease, actually physicians haven't been able to really move the market very much over the years, simply because it's very dangerous to try to go to another drug that hasn't provided any increase in benefit for those patients. It's put those patients at risk.

    是的。這是傑夫。我將重點放在您對頭部空間和 IBD 的評論。我的意思是 IBD 市場非常非常有吸引力。如果我們回顧歷史,坦白說,當我們開始實現 UC 和克羅恩病的適應症時,我們總是對 HUMIRA 的成長速度感到有點驚訝。我想說,我們對這種勢頭感到非常非常高興。勢頭非常非常大。因此,還有很大的空間。我們在市場動態中看到的是,與您可能認為的那樣,患者總是因為疾病的嚴重性而想要輪換藥物,實際上醫生無法真正推動市場在很大程度上改變。多年來,僅僅因為嘗試使用另一種沒有為這些患者帶來任何益處的藥物是非常危險的。這使這些患者處於危險之中。

  • So when you look at what Tom had highlighted, our ability with 2 complementary assets, for example, in the U.S., SKYRIZI position in the early lines, RINVOQ position in later lines, both of which have exceptional performance criteria versus the market. That gives us a lot of confidence. The other thing that gives us a lot of confidence, because there will be more competitive entries in the future, is we think our profiles are going to hold up exceptionally well. And then there's the commercial executional component, in most of the countries around the world, we have dual sales forces that basically will carry 2 products with 4 big indications. So our ability to compete in the market for share even as it gets a little more competitive over time, is still going to be very, very strong. So lots of headroom in the market, lots of unmet need in the market, and we believe we have the best position in the market for the foreseeable future.

    因此,當你看到Tom 強調的內容時,我們擁有2 個互補資產的能力,例如在美國,SKYRIZI 在早期生產線中的位置,RINVOQ 在後期生產線中的位置,這兩個資產相對於市場都具有卓越的績效標準。這給了我們很大的信心。另一件給我們很大信心的事情是,因為未來會有更多競爭性的參賽作品,我們認為我們的個人資料將保持得非常好。然後是商業執行部分,在世界上大多數國家,我們都有雙重銷售隊伍,基本上會銷售 4 個大適應症的 2 種產品。因此,即使隨著時間的推移,我們在市場上競爭份額的能力會變得更加強大,但仍然會非常非常強大。市場上有很大的空間,市場上有很多未滿足的需求,我們相信在可預見的未來我們在市場上處於最佳位置。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • And Gary, this is Rob. On your question regarding 2025 guidance, we do periodically update the long-term guidance for our portfolio. We're obviously very pleased with the momentum we're seeing both from SKYRIZI and RINVOQ, particularly in IBD. If you recall when we provided -- last time we provided guidance for SKYRIZI, we had about $2.5 billion of revenue in IBD in 2025 and it was $1.8 billion for RINVOQ. And those are obviously ramping very nicely. We have a lot of confidence. We periodically update that guidance, we'll find the right time to provide a holistic update to our long-term guide. But clearly, the momentum is there. And the Street reflects that, too. I mean if I look at consensus, not for SKYRIZI, I think it's around $11 billion. So it's $1 billion higher than our 2025 guide. So I think the market is recognizing the strong momentum, and we'll update that long-term guide holistically at the appropriate time.

    加里,這是羅布。關於您有關 2025 年指導的問題,我們會定期更新我們投資組合的長期指導。顯然,我們對 SKYRIZI 和 RINVOQ 的勢頭感到非常滿意,特別是在 IBD 領域。如果您還記得我們上次為 SKYRIZI 提供的指導,我們在 2025 年 IBD 的收入約為 25 億美元,而 RINVOQ 的收入為 18 億美元。這些顯然進展得非常好。我們有很大的信心。我們定期更新該指南,我們將找到合適的時間對我們的長期指南進行全面更新。但顯然,勢頭就在那裡。華爾街也反映了這一點。我的意思是,如果我看共識,而不是 SKYRIZI,我認為這個數字約為 110 億美元。因此,這比我們的 2025 年指南高出 10 億美元。因此,我認為市場正在認識到強勁的勢頭,我們將在適當的時候全面更新長期指南。

  • Operator

    Operator

  • Next question comes from Luisa Hector with Berenberg.

    下一個問題來自 Luisa Hector 和 Berenberg。

  • Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team

    Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team

  • To continue with IBD, I just wondered if you could talk a little bit more about the AbbVie pipeline emerging behind SKYRIZI and RINVOQ and how we think about that and maybe potential combinations with SKYRIZI. And with the recent competitor launch in psoriasis with a label where the FDA has asked to mention it at CNS, safety warnings. I wondered whether the FDA has mentioned anything to you about the review of label in that regard.

    繼續 IBD,我只是想知道您是否可以多談談 SKYRIZI 和 RINVOQ 背後出現的艾伯維 (AbbVie) 管道,以及我們如何看待這一點,以及與 SKYRIZI 的潛在組合。最近,競爭對手推出了針對牛皮癬的藥物,其標籤上 FDA 要求在 CNS 上提及安全警告。我想知道 FDA 是否向您提到有關這方面標籤審查的內容。

  • Roopal Thakkar - SVP of Development & Regulatory Affairs and Chief Medical Officer

    Roopal Thakkar - SVP of Development & Regulatory Affairs and Chief Medical Officer

  • It's Roopal. I'll take the IBD question. So you've heard already some mention of lutikizumab. That's our IL-1 alpha beta bispecific antibody. That's an in-house antibody. And we have observed data where there's resistance to anti-TNF and other biologics with patients with 1 beta signal. So we'll be entering into ulcerative colitis looking at a potential biomarker approach. But in addition to that, we will also be looking at a set of combinations as was already mentioned, for example, with SKYRIZI, we have lutikizumab. We have other agents as well. RIPK1 was also mentioned. There's also some partnerships that we have. GLP-2 is another mechanism we're interested in. And another one I'll mention is an IL-2 mutein.

    是魯帕爾。我來回答IBD問題。所以您已經聽說過一些關於 lutikizumab 的提及。這就是我們的 IL-1 αβ 雙特異性抗體。那是一種內部抗體。我們觀察到的數據顯示,具有 1β 訊號的患者對抗 TNF 藥物和其他生物製劑存在抗藥性。因此,我們將進入潰瘍性結腸炎,尋找潛在的生物標記方法。但除此之外,我們還將研究已經提到的一組組合,例如,我們有 SKYRIZI,我們有 lutikizumab。我們還有其他代理商。也提到了 RIPK1。我們還有一些合作關係。 GLP-2 是我們感興趣的另一個機制。我要提到的另一個機制是 IL-2 突變蛋白。

  • All of these are under assessment. And we do believe either you find a biomarker approach where you can see the high efficacy or if you want to see real transformational efficacy, you're going to have to go with a combination approach. So those are the assets we'll be looking at. Now moving on to the question, I think it was around depression and suicidal ideation if I heard it correctly. This was in an IL-17 class agent that was recently approved. We've also observed a similar warning and precaution previously also in the IL-17 class. In fact, that previous asset, in fact, had a REMS in place. Remember, SKYRIZI is an anti-IL-23 very different class. And to date, with all the data that's been generated across numerous indications, we don't see that type of signal at all nor do we have any of that in our label.

    所有這些都在評估中。我們確實相信,要么您找到一種可以看到高功效的生物標記方法,要么如果您想看到真正的轉化功效,則必須採用組合方法。這些就是我們將要關注的資產。現在繼續討論這個問題,如果我沒聽錯的話,我認為這是關於憂鬱症和自殺意念的。這是最近批准的 IL-17 類藥劑。我們先前也在 IL-17 類中觀察到類似的警告和預防措施。事實上,先前的資產實際上已經安裝了 REMS。請記住,SKYRIZI 是一種非常不同的抗 IL-23 類別。到目前為止,根據多種適應症產生的所有數據,我們根本沒有看到這種類型的訊號,我們的標籤中也沒有任何此類訊號。

  • And as we look at psoriasis therapy, that particular agent that's been mentioned has been available in Europe and our physicians really don't tell us that there's much of an uptake there. So SKYRIZI continues to perform well. Also, our label does not have the high rate of fungal infections that have been observed with the new one in the 17 class. And also, we've talked a lot about IBD. We -- the SKYRIZI doesn't also lead to IBD, which is another risk for the IL-17 class. And also with our dosing regimen, you get it at 0 and week 4, and then it's quarterly after that. With the new one, I think there's 5 doses that are required and potentially every 8 weeks or in heavier patients every 4 weeks. So we're very confident in SKYRIZI's position across indications, especially in psoriasis.

    當我們研究牛皮癬治療時,所提到的特定藥物已在歐洲上市,而我們的醫生實際上並沒有告訴我們那裡有很多採用。所以SKYRIZI繼續表現良好。此外,我們的標籤沒有像 17 類新標籤那樣出現高真菌感染率。而且,我們已經討論了很多關於 IBD 的問題。我們—SKYRIZI 也不會導致 IBD,這是 IL-17 類藥物的另一個風險。另外,按照我們的給藥方案,您可以在第 0 週和第 4 週注射一次,之後每季注射一次。對於新的一劑,我認為需要 5 劑,可能每 8 週注射一次,體重較重的患者每 4 週注射一次。因此,我們對 SKYRIZI 在各個適應症方面的地位非常有信心,尤其是在牛皮癬方面。

  • Operator

    Operator

  • Our next question comes from David Risinger with Leerink Partners.

    我們的下一個問題來自 Leerink Partners 的 David Risinger。

  • David Reed Risinger - Senior MD

    David Reed Risinger - Senior MD

  • Can you expand upon your vision for Oncology? Clearly, the company has compelling assets. But in light of an increasingly complex and competitive oncology landscape. Could you just paint a picture of how you see your portfolio evolving and opportunities to acquire assets when it may be difficult to see what's around the corner from, let's say, an emerging Oncology competitor in 3 to 4 years?

    您能擴展您對腫瘤學的願景嗎?顯然,該公司擁有引人注目的資產。但鑑於腫瘤學領域日益複雜和競爭激烈。您能否描繪一下您如何看待您的投資組合的演變以及收購資產的機會,因為您可能很難預見新興的腫瘤學競爭對手在 3 到 4 年內會發生什麼?

  • Thomas J. Hudson - Senior VP of Research & Development and Chief Scientific Officer

    Thomas J. Hudson - Senior VP of Research & Development and Chief Scientific Officer

  • This is Tom Hudson. We've been -- we certainly -- when we talk about 400, we're also talking about going in different space than lung and breast, where there's a lot of competition, like colon cancer, gastric cancer, pancreas. So seeing that as a target that's expressed in many other tumors, and that's why we've developed this with (inaudible), so we can go to a broader set of tumors. And that's where we're seeing a very good data with ABBV-400, even unselected patient population, third line plus, we saw a 22% response versus 2% to 3%. What's also interesting about this is, it's not just for colon cancer, but most chemos, most treatments and GI tumors have a lot of toxicity, a lot of diarrhea.

    這是湯姆·哈德森。我們一直在——當然——當我們談論 400 時,我們也在談論與肺癌和乳腺癌不同的領域,那裡有很多競爭,例如結腸癌、胃癌、胰腺癌。因此,將其視為在許多其他腫瘤中表達的靶標,這就是為什麼我們開發了它(聽不清楚),這樣我們就可以研究更廣泛的腫瘤。這就是我們在 ABBV-400 上看到的非常好的數據,即使是未經選擇的患者群體、三線以上,我們也看到了 22% 的緩解率和 2% 至 3% 的緩解率。有趣的是,它不僅適用於結腸癌,大多數化療、大多數治療方法和胃腸道腫瘤都有很多毒性,而且很多腹瀉。

  • And one of the things that excite the clinicians about this program is actually a very low rate of diarrhea. So what makes that not only can we see some efficacy in third line, but it sees we can move to earlier lines and combine with other therapies that have higher efficacy. So there's a lot of unmet need in GI tumors. And so this data, again, we're going to have more data in our next cohort at the end of this year. In CRC, we'll have different doses, and we'll also have potential cutoffs of biomarkers. So moving very well, but to actually in a big space, in GI tumors, as I've mentioned, even our GARP program, also where we've shown the best data is in liver cancer, which c-Met has also expressed.

    該計劃令臨床醫生興奮的事情之一實際上是腹瀉率非常低。那麼,是什麼使得我們不僅可以在第三線中看到一些療效,而且可以轉向早期線並與其他療效更高的療法相結合。因此,胃腸道腫瘤還有很多未滿足的需求。因此,這些數據,我們將在今年年底的下一批數據中獲得更多數據。在大腸直腸癌中,我們將採用不同的劑量,我們也將對生物標記進行潛在的限制。所以進展非常順利,但實際上在一個很大的空間,在胃腸道腫瘤中,正如我所提到的,甚至我們的GARP 項目,我們也顯示了肝癌的最佳數據,c-Met 也表達了這一點。

  • We have opportunities to go explore places where there's a big unmet need and the competition is not the same. Now the other targets because we talked about (inaudible) platform. We have others, 706, which is already in the clinic with success. Next year, we'll be going to 2 other indications, which -- for which there's less competition in terms of ADC space. So our strategy is actually to go and bring this an offering to a lot more cancer patients. I'll stop there, I'll stop there. Then maybe the team -- Roopal.

    我們有機會去探索那些有大量未滿足需求且競爭不一樣的地方。現在是其他目標,因為我們談到了(聽不清楚)平台。我們還有其他的,706,已經在臨床上取得成功。明年,我們將關注另外 2 個適應症,這兩個適應症在 ADC 領域的競爭較少。所以我們的策略其實是把這個產品帶給更多的癌症患者。我會停在那裡,我會停在那裡。然後也許是球隊——魯帕爾。

  • Roopal Thakkar - SVP of Development & Regulatory Affairs and Chief Medical Officer

    Roopal Thakkar - SVP of Development & Regulatory Affairs and Chief Medical Officer

  • It's Roopal. Let me add on a little bit. I think you may be also reflecting on some of the ESMO data that came out. I will mention long a little bit, we still see an opportunity with Teliso-V. We're going to get data later this year. But what we've already observed is 50% ORRs in a biomarker-selected population in the EGFR wild type. If you look at some of the data that has come out, the ORRs are probably right around 20% to 30%. We don't have all the breakdown of all the different lung subtypes. But one approach is to use a biomarker and then select the patient population rather than going so broadly that was observed at ESMO. The other thing I would say reflecting on the data that came out, if you looked at EGFR mutants in lungs, you see some higher levels of efficacy, either in the frontline or second line in that space. But that comes at a cost, and that's a chemo-like adverse event profile.

    是魯帕爾。讓我補充一點。我想您可能也在反思 ESMO 發布的一些數據。我會稍微提一下,我們仍然看到 Teliso-V 的機會。我們將於今年稍後獲得數據。但我們已經觀察到,在 EGFR 野生型生物標記選擇群體中,ORR 為 50%。如果你看一些已經出來的數據,ORR 可能在 20% 到 30% 左右。我們沒有所有不同肺部亞型的詳細資料。但一種方法是使用生物標誌物,然後選擇患者群體,而不是像 ESMO 觀察到的那樣廣泛選擇。我想說的另一件事是,根據得出的數據,如果你觀察肺部的 EGFR 突變體,你會看到一些更高水平的功效,無論是在該領域的一線還是二線。但這是有代價的,那就是類似化療的不良事件概況。

  • And those are things like nausea, vomiting, stomatitis, alopecia, fatigue. These are things that you may see slight increases in efficacy, but clearly, patients don't want that. And like -- as Tom was mentioning with our platform and including Teliso-V, we have an opportunity there in the mutant side to combine with osimertinib, which has a nice profile. And those mutant patients when they progress, half of them have highly expressed c-Met. So that's where a combo looks good. And then we're also seeing 50% ORR in that segment as well. And we have a plan to get into Phase III into that next year. And then as we think about heme, we spoke about 383, which we feel has best-in-class potential. And one of the things that we're observing with that one is the high level of efficacy. CRS, we're driving down past grade 3 and now driving down to get past grade 2.

    這些症狀包括噁心、嘔吐、口腔炎、掉髮、疲勞等。這些是你可能會看到療效略有增加的東西,但顯然,病人不希望這樣。就像 Tom 在我們的平台(包括 Teliso-V)中提到的那樣,我們有機會在突變體方面與具有良好特性的奧西替尼結合。而那些突變的患者,當病情進展時,其中一半的人c-Met高表達。這就是組合看起來不錯的地方。然後我們也看到該細分市場的 ORR 達到 50%。我們計劃明年進入第三階段。然後,當我們想到血紅素時,我們談到了 383,我們認為它具有同類最佳的潛力。我們觀察到的一件事是它的高效率。 CRS,我們正在駛過三年級,現在駛過二年級。

  • So that enables the potential where you may not need hospitalization. And what you see now with the BCMA dual engagers is not just hospitalization but a REMS. And what we would add to that is dose spacing potentially every other month. So that one is a very nice profile, and we're moving into Phase III with that one, and we continue to conduct a variety of combinations there so we can move into earlier lines of therapy in multiple myeloma. We are still moving into earlier lines in Phase IIIs with Epkinly in heme, which is another dual engager. We have an asset called 453, which is our next-gen BCL2 blocker. And then we have a BTK degrader called 101 that's also in clinic. So quite a comprehensive approach across oncology.

    這樣您就有可能不需要住院治療。現在,您在 BCMA 雙重接合器中看到的不僅僅是住院治療,還有 REMS。我們要補充的是可能每隔一個月的劑量間隔。因此,這是一個非常好的概況,我們正在進入第三階段,我們繼續在那裡進行各種組合,以便我們可以進入多發性骨髓瘤的早期治療。我們仍在進入第三階段的早期生產線,血紅素中的 Epkinly 是另一種雙重參與劑。我們有一個名為 453 的資產,它是我們的下一代 BCL2 阻斷劑。我們還有一款名為 101 的 BTK 降解劑,也已投入臨床使用。這是一種非常全面的腫瘤學方法。

  • Operator

    Operator

  • 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傑夫·米查姆。

  • Geoffrey Christopher Meacham - MD

    Geoffrey Christopher Meacham - MD

  • Just have a couple of quick ones, one on Immunology. So you guys have evaluated the impact from HUMIRA biosimilars beyond even 25%, is it your view that tail revenues are likely to be better than you initially modeled? And what, if anything, do STELARA, the delay in STELARA biosimilars impact this? And the second question, just on capital deployment. Just given your higher guidance, I know you guys just raised the dividend, but would you also say that the deal capacity is higher? I know you recently raised kind of M&A range and wondering if that's even going higher.

    只要有幾個快速的,一個是關於免疫學的。你們評估了 HUMIRA 生物相似藥的影響甚至超過 25%,你們認為尾部收入可能會比你們最初模型的更好嗎?如果有的話,STELARA、STELARA 生物相似藥的延遲會對此產生什麼影響?第二個問題,關於資本配置。鑑於你們更高的指導,我知道你們剛剛提高了股息,但你們是否也會說交易能力更高?我知道您最近提高了併購範圍,並想知道是否還會更高。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. It's -- Geoff, it's Jeff here. And we continue to study the tail. I mean it's something that we're -- we look very closely at. We continue to think that the HUMIRA tail will emerge sometime in '25 or '26. And that's looking at some of the international analogs, how we think we see pricing may move. I mean the one thing that we do believe is that you're not going to have a small molecule like tail, which is virtually nothing. There's going to be a subsegment of patients that are going to stay on HUMIRA. It's going to be modest, whether it's low price or low volume, but it will be there even in an interchangeable world.

    是的。這是——傑夫,我是傑夫。我們繼續研究尾巴。我的意思是,我們正在密切關注這一點。我們仍然認為 HUMIRA 尾部將在 25 或 26 年的某個時候出現。我們正在考慮一些國際類似情況,我們認為定價可能會改變。我的意思是,我們確實相信的一件事是,你不會有像尾巴這樣的小分子,它實際上什麼都不是。將會有一部分患者繼續使用 HUMIRA。無論是低價格還是低銷量,它都將是適度的,但即使在可互換的世界中,它也會存在。

  • We don't necessarily believe that since we've outperformed here in volume in '23 that that's going to fundamentally change our view on the tail at this point. And again, we're still highlighting that. In terms of STELARA, obviously, we think in the U.S. that will not come until -- and I think it was recently confirmed this week until sometime in '25. And so overall, we think that's a modest net positive for AbbVie in terms of how that may play out. But that's not the primary driver of our strategy. Our primary driver of the strategy is how distinctive we are across our indications with SKYRIZI versus STELARA, which I've already highlighted. So I hope that helps.

    我們不一定相信,既然我們在 23 年的成交量上表現出色,那麼這將從根本上改變我們對尾部的看法。我們仍然強調這一點。就 STELARA 而言,顯然,我們認為在美國,直到 25 年的某個時候,這才會在本週得到證實。總的來說,我們認為這對艾伯維來說是一個適度的淨利好,就其結果而言。但這並不是我們策略的主要驅動力。我們該策略的主要驅動力是我們的 SKYRIZI 與 STELARA 的適應症的獨特性,我已經強調過這一點。所以我希望這會有所幫助。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • And Geoff, this is Rob. You're right. We did lift the cap. We had put that $2 billion BD cap in place, although we are rapidly paying down debt. And we lifted that at the beginning of this year because we essentially -- by the end of this year, we're going to have paid off all the incremental financing from the Allergan transaction. As Scott mentioned, our net leverage ratio is around 1.8x. And I have said previously that as long as we're going to pass back to 2x that leverage in 2 to 3 years, that's the way we're thinking about balance sheet capacity. So as we look at it, there's nothing from a balance capacity standpoint that would limit us today for pursuing the opportunities we'd be interested in. So that's not a limiting factor. And to the extent that we continue to raise guidance and perform more strongly. That just means there's even more capacity. But there's -- at this point, that's not a rate limiter for the types of opportunities we'd be interested in.

    傑夫,這是羅布。你說得對。我們確實解除了限制。儘管我們正在迅速償還債務,但我們已經設定了 20 億美元的 BD 上限。我們在今年年初取消了這項限制,因為我們基本上 - 到今年年底,我們將還清艾爾建交易的所有增量融資。正如史考特所提到的,我們的淨槓桿率約為 1.8 倍。我之前說過,只要我們在 2 到 3 年內將槓桿率恢復到 2 倍,這就是我們考慮資產負債表能力的方式。因此,當我們看待它時,從平衡能力的角度來看,沒有什麼會限制我們今天追求我們感興趣的機會。所以這不是限制因素。我們繼續提高指導並表現得更強勁。這只是意味著有更多的容量。但目前,這並不是我們感興趣的機會類型的限制因素。

  • Operator

    Operator

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

    我們的下一個問題來自 BMO 資本市場的 Evan Seigerman。

  • Evan David Seigerman - MD & Senior BioPharma Research Analyst

    Evan David Seigerman - MD & Senior BioPharma Research Analyst

  • Congrats on the progress. I just wanted to touch on the dividend growth. So at first line, it seems that your dividend growth, while impressive, is slowing a bit relative to other recent periods. Maybe you could help us understand kind of what's driving this dynamic at play? Is it concerns around near-term performance of key products, HUMIRA erosion continuing next year? Or are you preserving capital for you (inaudible)? Maybe some color on that would be very helpful.

    祝賀取得的進展。我只想談談股息成長。因此,首先,您的股息成長雖然令人印象深刻,但相對於最近的其他時期,似乎有點放緩。也許您可以幫助我們了解是什麼推動了這種動態的發揮?是否擔心關鍵產品的近期表現,HUMIRA 明年將繼續受到侵蝕?還是你正在為你保留資本(聽不清楚)?也許一些顏色會很有幫助。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • So Evan, it's Rob. If you think about it, we're delivering dividend growth both in '23 and '24, while earnings are not growing, right? So then you look at the payout ratio we're at, we're going to be in the mid-50s. And we have said that over the long term, if you look at just across the industry as well, I'd say a good target is in, say, the mid- to high 40% payout ratio, which would mean that during this period where you see our payout ratio go up in the future, we're very committed to growing the dividend. We'll continue to grow the dividend, but we would expect then earnings would grow faster than dividend increases. So I would say we've gone through this period for a couple of years where we are still delivering a very nice dividend growth despite earnings declining.

    埃文,是羅布。如果你想一想,我們在 23 年和 24 年都實現了股息增長,而收益卻沒有增長,對嗎?那你看看我們目前的支付率,我們將在 50 多歲左右。我們說過,從長遠來看,如果你也看看整個產業,我會說一個好的目標是,比如說,中高40%的支付率,這意味著在此期間如果你看到我們的派息率在未來上升,我們將非常致力於增加股利。我們將繼續增加股息,但我們預期收益成長將快於股息成長。所以我想說,我們已經經歷了這個時期好幾年了,儘管獲利下降,但我們仍然實現了非常好的股息成長。

  • But given our commitment to that dividend, we're going to continue growing it. We'll likely see it step up from here, but not at the same rate as earnings growth because that payout ratio right now will be sitting in the mid-50s. So that's the way we think about it. Over the long term, we want to deliver a healthy, sustainable, growing dividend. And so we have a long view on this, and we are committed to delivering that growth to investors. And so that's the way we're thinking about it. We're going through a period of a couple of years here where earnings aren't growing. And then we see us return a robust growth, we'll step up that dividend again, but it's -- that's a dynamic that we're balancing here.

    但鑑於我們對股利的承諾,我們將繼續增加股利。我們可能會看到它從這裡開始上升,但與獲利成長的速度不同,因為目前的派息率將在 50 多歲左右。這就是我們的想法。從長遠來看,我們希望提供健康、可持續、不斷增長的股息。因此,我們對此有長遠的眼光,並致力於為投資者帶來這種成長。這就是我們思考的方式。我們正在經歷幾年收入沒有成長的時期。然後我們看到我們恢復了強勁的成長,我們將再次提高股息,但這就是我們在這裡平衡的動態。

  • Operator

    Operator

  • Our last question comes from Trung Huynh with UBS.

    我們的最後一個問題來自瑞銀集團的 Trung Huynh。

  • Trung Chuong Huynh - Analyst

    Trung Chuong Huynh - Analyst

  • I've got 2. Just one confirmation on the trough and then one on Aesthetics. So on the trough in '24, you mentioned that costs you will have the same margin in '24 is '23. So is it going to be a trough year on sales rather than the trough being driven by costs? And then second, again, just lots of noise on GLP-1s impacting Aesthetics. You've commented before on fillers and Ozempic face in the past, but there's potential impact on body sculpting. Is this actually anything that you're seeing coming through yet in the sales? And overall, is this trend a net positive or a net negative for you?

    我有 2 個。只有一個關於波谷的確認,然後一個關於美學的確認。因此,在 24 年的低谷中,您提到 24 年的成本與 23 年的利潤率相同。那麼,今年是否會是銷售的低谷一年,而不是成本驅動的低谷呢?其次,GLP-1 上的大量噪音影響了美觀。您過去曾評論過填充劑和臭氧臉部,但對塑身有潛在影響。這實際上是您在銷售中看到的情況嗎?整體而言,這種趨勢對您來說是淨利還是淨利?

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Trung, this is Rob. So clearly, we've communicated a floor for earnings. And Scott previously mentioned that expect a similar level of operating margin year-over-year. And so you can model the sales accordingly. It should be fairly clear.

    特朗,這是羅布。很明顯,我們已經傳達了獲利下限。史考特先前提到,預計營業利潤率將達到類似的年比水準。這樣您就可以相應地對銷售進行建模。這應該是相當清楚的。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Operating margin profile.

    營業利潤率概況。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Operating margin profile, yes. So we said the 46% to 47% is the way to think about operating margin profile in '23 and '24. We've given you the $11 EPS ex-IPR&D as a floor for next year. So I was just using those parameters to model revenue.

    營業利潤率概況,是的。所以我們說 46% 到 47% 是考慮 23 年和 24 年營業利益率的方法。我們已經為您提供了 11 美元的每股收益(不包括 IPR&D)作為明年的底線。所以我只是使用這些參數來模擬收入。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Carrie?

    嘉莉?

  • Carrie C. Strom - Senior VP of AbbVie & President of Global Allergan Aesthetics

    Carrie C. Strom - Senior VP of AbbVie & President of Global Allergan Aesthetics

  • And this is Carrie. For your question around the weight loss products and the impact on the Aesthetics business, I mean as we look at the long-term view of this market, we continue to think that anything that gets a subset of patients engaged in their appearance, which these weight loss products can do, that is a positive tailwind for our business. And we hear that from our customers and many of our customers are bringing these GLP-1s into their practice, and they see it as a natural opportunity to cross-sell. Now that said, in the short term, especially in an environment where discretionary spending is pressured and there could be trade-offs for higher-priced products such as fillers or body contouring. Now we're not necessarily seeing that as a driver.

    這是嘉莉。對於您關於減肥產品及其對美容業務影響的問題,我的意思是,當我們從長遠角度看待這個市場時,我們仍然認為,任何能讓一部分患者關注自己外表的東西,這些減肥產品能做到這一點,這對我們的業務來說是一個積極的推動力。我們從客戶那裡聽說,我們的許多客戶正在將這些 GLP-1 納入他們的實踐中,他們認為這是一個自然的交叉銷售機會。話雖如此,但從短期來看,尤其是在可自由支配支出受到壓力的環境下,可能需要對填充劑或塑身產品等價格較高的產品進行權衡。現在我們不一定將其視為驅動因素。

  • Right now, what we're seeing is the broader macroeconomic dynamics. But in the short term, that could be a trade-off in terms of share of wallet. But absolutely in a long term, this is something that is going to help patients get engaged in Aesthetics and be an opportunity for cross-selling.

    目前,我們看到的是更廣泛的宏觀經濟動態。但從短期來看,這可能是錢包份額的權衡。但絕對從長遠來看,這將有助於患者參與美容並成為交叉銷售的機會。

  • Elizabeth Shea - SVP of IR

    Elizabeth Shea - SVP of IR

  • And that concludes today's conference call. If you'd like to listen to a replay of the call, please visit our website at investors.abbvie.com. Thanks again for joining us.

    今天的電話會議到此結束。如果您想收聽電話會議的重播,請造訪我們的網站 Investors.abbvie.com。再次感謝您加入我們。

  • Operator

    Operator

  • Thank you, and that concludes today's conference. You may all disconnect at this time.

    謝謝大家,今天的會議到此結束。此時你們都可以斷開連線。