艾伯維 (ABBV) 2024 Q1 法說會逐字稿

內容摘要

艾伯維與高階主管召開電話會議,討論現任執行長的退休和強勁的財務表現。他們強調了各個治療領域的成長、全球美容銷售以及 III 期研究的積極成果。該公司公佈的調整後收益超出了預期,並上調了全年預期。

高管們討論了對市場份額、關鍵產品合約以及生物相似藥對 Humira 銷售的潛在影響的擔憂。他們對未來的成長前景,特別是 2025 年和 2026 年表示信心。

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 First Quarter 2024 Earnings Conference Call. (Operator Instructions) Today's call is also being recorded. If you have any objections, you may disconnect at this time.

    早安,感謝您的支持。歡迎參加艾伯維 2024 年第一季財報電話會議。 (操作員說明)今天的通話也正在錄音。如果您有任何異議,您可以此時斷開連接。

  • I would now like to introduce Ms. Liz Shea, Senior Vice President of Investor Relations. Ma'am, 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。女士,您可以開始了。

  • 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 Roopal Thakkar, Senior Vice President, Chief Medical Officer, Global Therapeutics. Joining us for the Q&A portion of the call is Tom Hudson, Senior Vice President, Chief Scientific Officer, Global Research.

    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 Global Therapeutics 資深副總裁兼首席醫療官 Roopal Thakkar。全球研究部高級副總裁兼首席科學官 Tom Hudson 參加了電話會議的問答部分。

  • 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.

    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。

  • 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 our regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions.

    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. I'm extremely pleased with our start to 2024 with first quarter results exceeding our expectations. Before we discuss our performance in more detail, I'd like to share my perspective on the planned CEO transition that was announced earlier this year. After serving more than 11 years as AbbVie's first CEO, I have decided to retire from the role effective July 1 of this year, and will continue to serve AbbVie as Executive Chairman of the Board.

    謝謝你,莉茲。大家早安,感謝您今天加入我們。我對 2024 年的開局感到非常滿意,第一季的業績超出了我們的預期。在我們更詳細地討論我們的業績之前,我想分享一下我對今年早些時候宣布的執行長換屆計劃的看法。在擔任艾伯維首任執行長超過 11 年後,我決定從今年 7 月 1 日起退休,並將繼續擔任艾伯維董事會執行主席。

  • As you've heard me say before, it is important that we choose the right time to make this critical leadership transition. The Board and I have been long planning for my eventual succession, and now is the opportune time to move forward with the transition as our business is performing very well and is in a strong position for the long term. We are successfully navigating the Humira U.S. loss of exclusivity. We have built an outstanding company culture, an important priority and competitive advantage. And our productive R&D engine, which has yielded numerous innovative new medicines for patients, will continue to fuel our robust pipeline for years to come.

    正如您之前聽我說過的,我們選擇正確的時間來進行這一關鍵的領導層過渡非常重要。董事會和我一直在為我的最終繼任計畫進行長期規劃,現在是推進過渡的最佳時機,因為我們的業務表現非常良好,並且長期處於有利地位。我們正在成功應對 Humira 在美國失去獨家經營權的情況。我們建立了優秀的企業文化、重要的優先事項和競爭優勢。我們高效的研發引擎為患者帶來了許多創新藥物,並將在未來幾年繼續為我們強大的產品線提供動力。

  • After a multiyear process, our Board has unanimously selected Rob Michael, our current President and Chief Operating Officer as AbbVie's next CEO. I have known and worked with Rob for many, many years, and he is an excellent choice as my successor. He brings the experience, the leadership and the strategic vision to build on AbbVie's past successes, advance our strategy and enhance shareholder value. Since our inception, Rob has held several important leadership positions that have collectively had a tremendous impact on AbbVie, from establishing our financial planning organization to navigating the end of exclusivity for Humira in the U.S. to driving key business development opportunities that have been critical to diversify our business and support long-term growth, including the acquisitions of Allergan and ImmunoGen and the pending Cerevel transaction.

    經過多年的努力,我們的董事會一致選擇現任總裁兼營運長 Rob Michael 擔任艾伯維的下一任執行長。我認識 Rob 並與他共事多年,他是我的繼任者的絕佳選擇。他帶來了經驗、領導力和策略願景,以鞏固艾伯維過去的成功,推動我們的策略並提高股東價值。自公司成立以來,Rob 擔任過多個重要領導職位,這些職位對艾伯維產生了巨大影響,從建立我們的財務規劃組織到結束Humira 在美國的獨家經營權,再到推動對多元化至關重要的關鍵業務發展機會我們的業務並支持長期成長,包括收購 Allergan 和 ImmunoGen 以及懸而未決的 Cerevel 交易。

  • Looking back, AbbVie has evolved tremendously as an independent company, and our performance has truly been exceptional. Since our inception, we've grown our revenue from $18 billion to $55 billion. Our market capitalization has increased substantially from $54 billion to roughly $300 billion today. We achieved a total shareholder return of more than 675%, which is top tier relative to our peers. And importantly, we have substantially increased our investments in R&D to discover and develop new medicines that have the potential to improve the lives of patients. As I look ahead, our company has never been stronger and our future has never been brighter. We are executing well across all aspects of our business, and our long-term growth prospects remain very strong.

    回顧過去,艾伯維作為一家獨立公司已經取得了巨大的發展,我們的業績確實非常出色。自成立以來,我們的營收已從 180 億美元成長到 550 億美元。我們的市值已從 540 億美元大幅增加到今天的約 3,000 億美元。我們實現了超過675%的股東總回報率,在同業中處於領先水準。重要的是,我們大幅增加了研發投資,以發現和開發有潛力改善病患生活的新藥。展望未來,我們的公司從未如此強大,我們的未來也從未如此光明。我們業務的各個方面都執行良好,我們的長期成長前景仍然非常強勁。

  • In summary, it has been a privilege and immensely gratifying to serve with all of my AbbVie colleagues for the past 11 years, growing AbbVie into what it is today. And I look forward to continuing to work with Rob and the leadership team to create meaningful value for our shareholders and all of our stakeholders. And I also would like to take this opportunity to thank all of our shareholders for the trust and confidence you put in me as AbbVie's CEO.

    總之,在過去 11 年裡與我所有的艾伯維同事一起服務,使艾伯維成長為今天的樣子,我感到非常榮幸和非常高興。我期待著繼續與 Rob 和領導團隊合作,為我們的股東和所有利害關係人創造有意義的價值。我也想藉此機會感謝所有股東對我作為艾伯維執行長的信任和信心。

  • With that, I'll turn the call over to Rob for comments on our recent business performance. Rob?

    接下來,我將把電話轉給 Rob,請他對我們最近的業務表現發表評論。搶?

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Thank you, Rick. Before I comment on our first quarter performance, I want to congratulate Rick on his exceptional leadership of AbbVie over the past 11 years. During his tenure, Rick made several strategic moves that have positioned AbbVie to have a bright future beyond Humira, consistently drove the organization to deliver very strong performance and demonstrated that genuine care for our employees, patients, shareholders and communities that has defined who we are as a company today. It has been my privilege to work closely with Rick over many years, and I look forward to working with him in his role as Executive Chairman. AbbVie's outlook is very strong, and I am excited about the remarkable impact that we will continue to have on patients' lives.

    謝謝你,瑞克。在評論我們第一季的業績之前,我想祝賀 Rick 在過去 11 年裡對艾伯維 (AbbVie) 的卓越領導。在任職期間,Rick 採取了多項策略舉措,使艾伯維(AbbVie) 擁有了超越修美樂(Humira) 的光明未來,持續推動該組織取得非常強勁的業績,並證明了對員工、患者、股東和社區的真誠關懷,這也決定了我們的定位今天作為一家公司。多年來我很榮幸與 Rick 密切合作,我期待與他作為執行主席一起工作。艾伯維的前景非常樂觀,我對我們將繼續對患者生活產生的顯著影響感到興奮。

  • Turning to first quarter performance. We're off to an excellent start to the year with strong top and bottom line results. We reported adjusted earnings per share of $2.31, which is $0.11 above our guidance midpoint. Total net revenues were $12.3 billion, approximately $400 million ahead of our expectations. This overachievement was driven by our ex-Humira growth platform, which delivered revenue growth of more than 15% this quarter and includes continued robust sales from Skyrizi and Rinvoq with combined growth above 50% in their fifth full year on the market as well as double-digit revenue growth from several other key products, including Venclexta, Vraylar, Ubrelvy and Qulipta. This broad-based sales momentum clearly demonstrates the strength of our diversified portfolio with multiple growth drivers to support our long-term outlook.

    轉向第一季的業績。我們今年取得了良好的開局,並取得了強勁的營收和淨利。我們公佈的調整後每股收益為 2.31 美元,比我們的指導中位數高出 0.11 美元。總淨收入為 123 億美元,比我們的預期高出約 4 億美元。這一超常成績是由我們的前Humira 增長平台推動的,該平臺本季度收入增長超過15%,其中Skyrizi 和Rinvoq 的銷售持續強勁,在市場第五個完整年度中綜合增長超過50%,並且實現了兩倍以上的成長。這種廣泛的銷售勢頭清楚地表明了我們多元化投資組合的實力,以及支持我們長期前景的多種成長動力。

  • We are also making excellent progress with several of our near-term priorities. We recently completed the acquisition of ImmunoGen, which accelerates our entry into the solid tumor market and strengthens our oncology pipeline. The integration has been seamless, and we are impressed by the caliber of talent we have welcomed into AbbVie. We also remain on track with the pending acquisition of Cerevel, which we anticipate will close in the middle of the year. Cerevel's pipeline of differentiated assets will further augment our neuroscience portfolio.

    我們在幾個近期優先事項方面也取得了顯著進展。我們最近完成了對ImmunoGen的收購,這加速了我們進入實體瘤市場並加強了我們的腫瘤產品線。整合是無縫的,我們對艾伯維歡迎的優秀人才印象深刻。我們也持續推動即將進行的 Cerevel 收購,預計該收購將在今年年中完成。 Cerevel 的差異化資產管道將進一步擴大我們的神經科學產品組合。

  • In addition, we continue to advance our R&D pipeline and invest for long-term growth. This progress includes the FDA's full approval of Elahere for FR alpha-positive, platinum-resistant ovarian cancer, a meaningful first-in-class treatment for patients and a significant long-term growth opportunity for AbbVie in solid tumors. We also gained U.S. approval of Juvederm Voluma XC for temple hollows, further strengthening our leadership in aesthetic fillers. And we executed several business development opportunities, adding novel early-stage programs and partnerships in oncology and immunology. Given the strong results this quarter, we are raising our full year adjusted earnings per share guidance by $0.16, and now expect adjusted EPS between $11.13 and $11.33.

    此外,我們繼續推動研發管道並投資於長期成長。這項進展包括 FDA 完全批准 Elahere 用於治療 FR α 陽性、鉑類抗藥性的卵巢癌,這是對患者有意義的一流治療方法,也是艾伯維在實體瘤領域的重要長期成長機會。我們也獲得了美國批准用於太陽穴空洞的 Juvederm Voluma XC,進一步加強了我們在美容填充劑領域的領導地位。我們也執行了多項業務發展機會,在腫瘤學和免疫學領域增加了新穎的早期計畫和合作關係。鑑於本季的強勁業績,我們將全年調整後每股收益指引上調 0.16 美元,目前預計調整後每股收益將在 11.13 美元至 11.33 美元之間。

  • In summary, this is an exciting time for AbbVie, and I am extremely pleased with the momentum of our diverse portfolio. We're off to an excellent start to the year, and we are well positioned to deliver a high single-digit revenue CAGR through the end of the decade.

    總之,這對艾伯維來說是一個令人興奮的時刻,我對我們多元化投資組合的勢頭感到非常滿意。我們今年有一個良好的開端,並且我們有能力在本十年末實現高個位數的收入複合年增長率。

  • With that, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff?

    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. I'll start with the quarterly results for immunology, which delivered total revenues of approximately $5.4 billion, exceeding our expectations. Skyrizi global sales were $2 billion, reflecting operational growth of 48%. We continue to see exceptional momentum across all of the approved indications. In psoriasis, Skyrizi is the clear market leader in the U.S. biologic psoriasis market with a total prescription share now above 35%. That's more than double the share of the next closest biologic therapy.

    謝謝你,羅布。我將從免疫學的季度業績開始,該季度的總收入約為 54 億美元,超出了我們的預期。 Skyrizi 全球銷售額為 20 億美元,營運成長 48%。我們繼續看到所有已批准適應症的強勁勢頭。在乾癬領域,Skyrizi 是美國生物乾癬市場明顯的市場領導者,目前總處方份額超過 35%。這是排名第二的生物療法的兩倍多。

  • Share is also ramping nicely in PsA, especially in the dermatology segment, where we are now capturing 1 out of every 4 new or switching in-play biologic patients. Globally, Skyrizi has achieved psoriatic in-play share leadership in nearly 30 key countries. In IBD, Skyrizi is on track to add more than $1 billion of incremental sales growth this year. We are seeing tremendous performance in Crohn's disease, where our compelling head-to-head data versus Stelara is driving a meaningful inflection of patient share. As a result, we have now achieved in-play share leadership in Crohn's across all lines of therapy in both the U.S. and Japan as well as other key markets around the world.

    乾癬性關節炎的份額也在快速增長,尤其是在皮膚科領域,我們現在每 4 個新的或正在轉換的生物製劑患者中就有 1 個被捕獲。在全球範圍內,Skyrizi 在近 30 個主要國家的銀屑病市場份額中處於領先地位。在 IBD 領域,Skyrizi 今年預計將實現超過 10 億美元的增量銷售成長。我們看到克羅恩病的巨大表現,我們與 Stelara 相比令人信服的頭對頭數據正在推動患者份額發生有意義的變化。因此,我們現在在美國和日本以及世界其他主要市場的克隆氏症所有治療領域都取得了市場份額領先地位。

  • And finally, we are preparing for the launch of Skyrizi in ulcerative colitis, which represents another substantial long-term growth driver. We expect approval decisions in the middle of this year and anticipate rapid access in the U.S. following our launch. Given the robust frontline capture for Skyrizi in Crohn's and the exceptional bio-naïve data we have generated in UC, we anticipate a strong launch.

    最後,我們正在準備推出治療潰瘍性結腸炎的 Skyrizi,這是另一個重要的長期成長動力。我們預計將在今年年中做出批准決定,並預計在我們推出後將迅速在美國上市。鑑於 Skyrizi 在克羅恩病中的強大前線捕獲以及我們在 UC 中生成的出色的生物數據,我們預計會出現強勁的推出。

  • Turning now to Rinvoq with global sales of approximately $1.1 billion, reflecting operational growth of 61.9%. In rheum, we continue to see strong prescription growth across each of the 4 approved indications, and I'm especially pleased with our performance in rheumatoid arthritis, where Rinvoq has achieved in-play share leadership in nearly 20 key international markets. Atopic dermatitis is tracking in line with our expectations with continued market share momentum globally.

    現在轉向 Rinvoq,其全球銷售額約為 11 億美元,營運成長率為 61.9%。在大黃方面,我們繼續看到 4 個已批准適應症的處方增長強勁,我對我們在類風濕關節炎方面的表現尤其滿意,Rinvoq 在近 20 個主要國際市場中取得了實際份額領先地位。異位性皮膚炎的發展符合我們的預期,全球市佔率持續成長。

  • Importantly, we recently announced positive results from LEVEL UP, our second head-to-head study in AD. LEVEL UP demonstrated Rinvoq's superiority for patients starting therapy on the 15-milligram dose versus Dupixent across key efficacy parameters, including the high levels of skin clearance and itch reduction. We anticipate these strong head-to-head results will support additional share capture, especially given Rinvoq's label use in the U.S., which requires that initiation with a 15-milligram dose.

    重要的是,我們最近宣布了 LEVEL UP 的積極結果,這是我們在 AD 領域的第二項頭對頭研究。 LEVEL UP 證明了 Rinvoq 對於以 15 毫克劑量開始治療的患者在關鍵療效參數(包括高水平的皮膚清除和瘙癢減少)方面優於 Dupixent。我們預計這些強勁的正面交鋒結果將支持額外的份額捕獲,特別是考慮到 Rinvoq 在美國的標籤使用,這需要以 15 毫克劑量啟動。

  • And in IBD, Rinvoq's uptake continues to be very strong. Rinvoq is capturing high-teens in-play patient share in ulcerative colitis as well as mid-teens in-play patient share in Crohn's disease. This performance is especially encouraging, recognizing that we are still relatively early in the launch phase for both the UC and CD indications, and the lines of therapy are also expanding with second line plus growing even faster as patients cycle to newer, higher-efficacy agents like Rinvoq and IBD.

    在 IBD 領域,Rinvoq 的應用仍然非常強勁。 Rinvoq 正在統計青少年中患有潰瘍性結腸炎的患者比例以及中青少年患有克隆氏症的患者比例。這一表現尤其令人鼓舞,因為我們認識到我們仍處於UC 和CD 適應症的啟動階段相對較早的階段,並且治療範圍也在隨著二線的擴大而擴大,而且隨著患者循環使用更新、更有效率的藥物,治療範圍甚至會更快例如 Rinvoq 和 IBD。

  • Turning now to Humira, which delivered global sales of approximately $2.3 billion, down 35.2% on an operational basis due to biosimilar competition. Erosion in the U.S. played out slightly better than our expectations in the quarter with the vast majority of the impact this quarter driven by price. As previously communicated, the recent changes to the CVS template formularies were anticipated in our full year outlook for U.S. Humira, and the volume impact is tracking in line with our expectations. Our guidance has also contemplated the impact of additional formulary changes that are expected to go into effect over the course of the year. We continue to anticipate that Humira will maintain parity access to biosimilars for a significant majority of patient lives this year.

    現在談談 Humira,由於生物相似藥的競爭,該公司的全球銷售額約為 23 億美元,營運基礎上下降了 35.2%。本季美國的侵蝕情況略優於我們的預期,本季的絕大多數影響是由價格驅動的。正如之前所傳達的,我們對美國 Humira 的全年展望中預計了最近 CVS 模板處方集的變化,並且數量影響符合我們的預期。我們的指導方針還考慮了預計將在今年生效的其他處方變更的影響。我們繼續預計,修美樂今年將維持絕大多數患者獲得生物相似藥的平等機會。

  • Moving now to oncology, where total revenues were more than $1.5 billion, exceeding our expectations. Imbruvica global revenues were $838 million, down 4.5%, reflecting continued competitive pressure in CLL. Venclexta global sales were $614 million, up 16.3% on an operational basis, and we are seeing robust momentum internationally with strong performance for both CLL and AML. Elahere generated $64 million of sales to AbbVie, reflecting a partial quarter of revenue following the February close of the ImmunoGen acquisition. The Elahere sales and marketing team is executing very well, and I'm pleased with the smooth integration into our commercial organization.

    現在轉向腫瘤學,總收入超過 15 億美元,超出了我們的預期。 Imbruvica 全球營收為 8.38 億美元,下降 4.5%,反映出 CLL 領域持續的競爭壓力。 Venclexta 全球銷售額為 6.14 億美元,營運基礎上成長 16.3%,我們看到國際上的強勁勢頭,CLL 和 AML 都有強勁的表現。 Elahere 為 AbbVie 帶來了 6,400 萬美元的銷售額,反映了 2 月份完成 ImmunoGen 收購後收入的部分季度。 Elahere 銷售和行銷團隊執行得非常好,我很高興能夠順利融入我們的商業組織。

  • We anticipate that the recent positive updates in the NCCN Guidelines for both platinum-sensitive and platinum-resistant ovarian cancer patients as well as the full label approval which, of course, includes the compelling overall survival data that has never been achieved before in these platinum-resistant patients will continue to drive strong Elahere uptake. Lastly, the global launch of Epkinly in third-line plus DLBCL is also performing well, and we remain on track for the potential label expansion for follicular lymphoma later this year.

    我們預計 NCCN 指南最近針對鉑類敏感和鉑類抗藥性卵巢癌患者的積極更新,以及全面的標籤批准,當然,其中包括以前從未在這些鉑類藥物中獲得的令人信服的總體生存數據耐藥物患者將持續推動Elahere 的強勁吸收。最後,Epkinly 在三線+ DLBCL 的全球上市也表現良好,我們仍有望在今年稍後擴大濾泡性淋巴瘤的標籤。

  • Neuroscience total revenues were nearly $2 billion, up 16% on an operational basis, again, ahead of our expectations. This robust performance is driven by continued double-digit growth of Vraylar with global sales of $694 million, Ubrelvy with total revenue of $203 million and Qulipta with global sales of $131 million. Each of these leading assets continue to gain share and remain competitively well positioned. Botox Therapeutic is also performing well, especially in chronic migraine. Total global sales were $748 million, up 4.5% on an operational basis.

    神經科學總收入接近 20 億美元,營運基礎上成長 16%,再次超出我們的預期。這一強勁業績的推動因素包括:Vraylar(全球銷售額為 6.94 億美元)、Ubrelvy(總收入為 2.03 億美元)和 Qulipta(全球銷售額為 1.31 億美元)持續兩位數成長。這些領先資產中的每一項都在繼續擴大份額並保持競爭優勢。 Botox Therapeutic 也表現良好,尤其是在慢性偏頭痛方面。全球總銷售額為 7.48 億美元,營運基礎上成長 4.5%。

  • And finally, we are very excited about 951, which will be commercialized as VYALEV in the U.S. and represents a potentially transformative next-generation therapy for advanced Parkinson's disease. Feedback from the launches in Japan and Europe have been very encouraging, and we remain on track for commercial approval in the U.S. later this year. So overall, I'm extremely pleased with the strong and balanced growth across our therapeutic portfolio this quarter, a testament to our differentiated product profiles and commercial execution.

    最後,我們對 951 感到非常興奮,它將在美國以 VYALEV 商品化,代表了晚期帕金森氏症的潛在變革性下一代療法。日本和歐洲的上市回饋非常令人鼓舞,我們仍有望在今年稍後在美國獲得商業批准。總體而言,我對本季我們的治療產品組合強勁且平衡的成長感到非常滿意,這證明了我們差異化的產品概況和商業執行力。

  • And with that, I'll turn the call over to Carrie for additional comments on aesthetics. Carrie?

    這樣,我會將電話轉給 Carrie,以獲取有關美學的更多評論。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. First quarter Global aesthetics sales were over $1.2 billion, reflecting a modest decline on an operational basis. In the U.S., aesthetics sales of $776 million were roughly flat versus the prior year. We continue to see sustained momentum in the facial injectable market recovery that emerged in the back half of last year. Consistent with the past few quarters, the toxin market grew by mid-single-digit percentage. We saw similar year-over-year increases in the number of facial filler procedures, representing a return to quarterly market growth for the first time since early 2022.

    謝謝你,傑夫。第一季全球美容銷售額超過 12 億美元,反映出營運基礎上的小幅下滑。在美國,美容產品銷售額為 7.76 億美元,與去年基本持平。我們繼續看到去年下半年出現的臉部注射市場復甦的持續勢頭。與過去幾季一致,毒素市場以中個位數百分比成長。我們看到臉部填充手術數量出現了類似的同比增長,這意味著自 2022 年初以來首次恢復季度市場成長。

  • From a competitive perspective, our U.S. aesthetics portfolio continues to perform well. Market share for both Botox Cosmetic and Juvederm was stable in the first quarter as these assets remain the clear market leaders. While we're pleased that the market and share trends across U.S. facial injectables are aligned with our previous expectations, our first quarter results were impacted by customers holding lower-than-normal inventory levels at quarter end. This dynamic relates to a decision made during the quarter to shift the timing of certain promotional activities into the second quarter. We, therefore, expect inventory levels to normalize in the second quarter and remain on track to deliver full year aesthetics sales growth in the U.S.

    從競爭角度來看,我們的美國美容產品組合持續表現良好。 Botox Cosmetic 和 Juvederm 的市佔率在第一季保持穩定,因為這些資產仍然是明顯的市場領導者。雖然我們很高興美國臉部注射劑的市場和份額趨勢與我們先前的預期一致,但我們第一季的業績受到季度末客戶庫存水準低於正常水準的影響。這種動態與本季做出的將某些促銷活動的時間轉移到第二季的決定有關。因此,我們預計第二季庫存水準將正常化,並有望實現美國全年美容銷售成長。

  • Internationally, first quarter aesthetics sales were $473 million, reflecting an operational decline of 5.5%. Consistent with our expectations, growth in China was impacted by persistent economic headwinds as well as a challenging comparison versus the first quarter of last year, which benefited from a robust recovery post COVID. We are monitoring the economic developments across China and continue to anticipate a recovery in the second half of this year.

    在國際範圍內,第一季美容銷售額為 4.73 億美元,營業收入下降 5.5%。與我們的預期一致,中國的成長受到持續的經濟逆風以及與去年第一季相比具有挑戰性的影響,去年第一季受益於新冠疫情後的強勁復甦。我們正在監測中國各地的經濟發展,並繼續預計今年下半年將出現復甦。

  • Our pipeline continues to generate important new assets. Uptake of our recently launched VOLUX and SkinVive products remain strong, underscoring the importance of innovation within aesthetics. Given this context, we are excited for the upcoming launch of Juvederm Voluma XC for the treatment of temple hollows. As the only HA dermal filler approved for use in the upper face, we anticipate the Voluma XC introduction will activate more consumers and support the long-term growth of our filler portfolio.

    我們的管道繼續產生重要的新資產。我們最近推出的 VOLUX 和 SkinVive 產品的接受度依然強勁,凸顯了美學創新的重要性。有鑑於此,我們對即將推出用於治療太陽穴空洞的 Juvederm Voluma XC 感到興奮。作為唯一被批准用於上面部的 HA 真皮填充劑,我們預計 Voluma XC 的推出將吸引更多消費者並支持我們填充劑產品組合的長期成長。

  • And within our toxin pipeline, we continue to expect FDA approval of the platysma prominence indication for Botox near the end of this year, enhancing Botox growth potential as a noninvasive treatment to reduce the appearance of vertical neck bands and improve jawline definition. We also remain on track to submit a new drug application for our short-acting toxin BoNT/E before the end of this year. This novel toxin has demonstrated a rapid onset of action as well as a short duration of effect, meaningfully lowering the barrier for toxin adoption across consumers who have been considering but hesitant to try Botox. Given this profile, BoNT/E has significant market expansion potential as satisfied patients would naturally convert to Botox. Overall, the underlying trends across our aesthetics portfolio align well with our previous expectations, and we remain on track to deliver high single-digit global aesthetics growth this year.

    在我們的毒素管道中,我們繼續預計 FDA 將在今年年底批准 Botox 的頸闊肌突出適應症,從而增強 Botox 作為非侵入性治療的增長潛力,以減少垂直頸帶的出現並改善下巴輪廓。我們也將繼續在今年年底前提交短效毒素 BoNT/E 的新藥申請。這種新型毒素已表現出起效快、作用持續時間短的特點,顯著降低了那些一直在考慮但猶豫是否嘗試使用肉毒桿菌的消費者採用毒素的障礙。有鑑於此,BoNT/E 具有巨大的市場擴張潛力,因為滿意的患者自然會轉向使用 Botox。總體而言,我們的美學產品組合的基本趨勢與我們先前的預期非常吻合,並且我們今年仍有望實現全球美學的高個位數成長。

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

    這樣,我會將電話轉給 Roopal。

  • Roopal Thakkar - Senior VP & Chief Medical Officer of Global Therapeutics

    Roopal Thakkar - Senior VP & Chief Medical Officer of Global Therapeutics

  • Thank you, Carrie. I'll start with immunology. We recently announced positive top line results from 2 Phase III studies for Rinvoq in dermatology and rheumatology. In the LEVEL UP study, which evaluated Rinvoq against dupilumab in atopic dermatitis, Rinvoq demonstrated superiority on the primary endpoint at week 16, which was a composite endpoint measuring skin clearance and itch reduction. Twice as many Rinvoq patients achieved this very stringent endpoint compared to dupilumab. Rinvoq also demonstrated superiority on all ranked secondary endpoints in this trial.

    謝謝你,嘉莉。我將從免疫學開始。我們最近宣布了 Rinvoq 在皮膚病學和風濕病學領域的兩項 III 期研究的積極頂線結果。在評估 Rinvoq 與 dupilumab 治療異位性皮膚炎的 LEVEL UP 研究中,Rinvoq 在第 16 週的主要終點(衡量皮膚清除和瘙癢減少的複合終點)上表現出優越性。與 dupilumab 相比,達到這一非常嚴格終點的 Rinvoq 患者數量是其兩倍。在此試驗中,Rinvoq 還在所有排名次要終點上表現出了優越性。

  • LEVEL UP was a study in which patients started on Rinvoq 15 milligrams and could escalate to 30 milligrams if they did not achieve treatment goals, which is how Rinvoq is prescribed for atopic dermatitis in the U.S. We also saw very rapid responses with Rinvoq demonstrating superiority on itch as early as week 2 and on skin lesions as early as week 4. Rinvoq's safety profile in the level of trial was consistent with what has been observed in previous studies. There were no serious infections in patients treated with Rinvoq and one in the dupilumab group. The rate of serious adverse events was similar across treatment arms. There were no malignancies, MACE events or VTEs reported in either treatment group. Based on these data as well as results from previous Phase III studies, we remain very confident in Rinvoq's profile in atopic dermatitis, and we believe it offers meaningful advantages over other products on the market today.

    LEVEL UP 是一項研究,患者開始服用15 毫克Rinvoq,如果沒有達到治療目標,則可以升級至30 毫克,這就是Rinvoq 在美國用於治療異位性皮膚炎的方式。反應,顯示出在以下方面的優越性:最早在第 2 週就出現瘙癢,最早在第 4 週就出現皮膚損傷。 Rinvoq 治療組和 dupilumab 組的 1 名患者均未出現嚴重感染。各治療組的嚴重不良事件發生率相似。兩個治療組均未報告惡性腫瘤、MACE 事件或 VTE。根據這些數據以及先前的 III 期研究結果,我們對 Rinvoq 在異位性皮膚炎方面的表現仍然非常有信心,並且我們相信它比當今市場上的其他產品具有有意義的優勢。

  • We also announced positive top line results from our Phase III SELECT giant cell arteritis trial, which evaluated Rinvoq in combination with a 26-week steroid taper regimen compared to patients receiving placebo in combination with a 52-week steroid taper. In this study, Rinvoq 15 milligrams met the primary and key secondary endpoints, demonstrating superiority on sustained remission from week 12 through week 52 as well as on disease flare and reduction in cumulative steroid exposure at week 52.

    我們也宣布了 III 期 SELECT 鉅細胞動脈炎試驗的積極頂線結果,該試驗評估了 Rinvoq 聯合 26 週類固醇逐漸減量方案與接受安慰劑聯合 52 週類固醇逐漸減量方案的患者的情況。在這項研究中,Rinvoq 15 毫克達到了主要和關鍵的次要終點,證明了在第 12 週至第 52 週持續緩解以及第 52 週疾病發作和累積類固醇暴露減少的優越性。

  • Importantly, Rinvoq's safety profile was consistent with what has been observed in more than 15,000 patients previously studied across controlled trials. The mean age in this population was 71, which is the oldest population studied to date with Rinvoq, and the average prednisone equivalent dose at baseline was almost 35 milligrams. Rates of serious adverse events and VTEs were similar across treatment groups. There were no MACE events in the Rinvoq arm, while there were 2 in the placebo group. Based on the results from the SELECT-GCA trial, we believe Rinvoq has the potential to be a safe and tolerable oral treatment option. We plan to submit our regulatory applications for this indication later this year.

    重要的是,Rinvoq 的安全性與先前在對照試驗中研究的 15,000 多名患者中觀察到的結果一致。該族群的平均年齡為 71 歲,這是迄今為止 Rinvoq 研究中最年長的族群,基線時的平均潑尼松當量劑量幾乎為 35 毫克。各治療組的嚴重不良事件和靜脈血栓栓塞發生率相似。 Rinvoq 組沒有發生 MACE 事件,而安慰劑組則有 2 起。根據 SELECT-GCA 試驗的結果,我們相信 Rinvoq 有潛力成為安全且可耐受的口服治療選擇。我們計劃在今年稍後提交針對該適應症的監管申請。

  • We continue to make very good progress with our inflammatory bowel disease programs. We anticipate several advancements this year, including the initiation of a Phase II study for lutikizumab in ulcerative colitis; the start of our Phase II Crohn's disease platform study, which will evaluate combinations of Skyrizi with lutikizumab and other novel biologics. And we remain on track for approval decisions for Skyrizi in ulcerative colitis, with the U.S. expected in the second quarter and Europe in the second half of the year.

    我們的發炎性腸道疾病計畫持續取得良好進展。我們預計今年將取得幾項進展,包括啟動 lutikizumab 治療潰瘍性結腸炎的 II 期研究;我們的 II 期克隆氏症平台研究開始,該研究將評估 Skyrizi 與 lutikizumab 和其他新型生物製劑的組合。我們仍在為治療潰瘍性結腸炎的 Skyrizi 做出批准決定,預計美國將在第二季批准,歐洲將在今年下半年批准。

  • We also continue to invest in external innovation to expand our immunology pipeline, as evidenced by 4 deals that we announced in the first quarter. These include the acquisition of Landos Biopharma, which brings an oral NLRX1 agonist currently in Phase II for ulcerative colitis; a partnership with OSE Immunotherapeutics to develop a novel ChemR23 agonist antibody for inflammatory conditions, such as IBD and RA; a collaboration with Parvus Therapeutics to utilize their immune tolerization platform to develop novel therapies for IBD; and a collaboration with Tentarix Biotherapeutics to develop conditionally active, multi-specific biologics in immunology and oncology. We are excited to partner with these companies who are all pursuing very innovative approaches to developing transformative therapies.

    我們也繼續投資外部創新,以擴大我們的免疫學產品線,我們在第一季宣布的 4 筆交易證明了這一點。其中包括收購 Landos Biopharma,該公司帶來了目前處於 II 期治療潰瘍性結腸炎的口服 NLRX1 激動劑;與 OSE Immuntherapeutics 合作開發一種新型 ChemR23 激動劑抗體,用於治療 IBD 和 RA 等發炎性疾病;與 Parvus Therapeutics 合作,利用其免疫耐受平台開發 IBD 新型療法;並與 Tentarix Biotherapeutics 合作開發免疫學和腫瘤學領域的有條件活性、多特異性生物製劑。我們很高興與這些公司合作,他們都在尋求非常創新的方法來開發變革性療法。

  • Moving to oncology, where in the quarter, we closed the ImmunoGen transaction, which brings exciting programs in both solid and blood cancers. Last month, Elahere received full approval from the FDA for FR alpha-positive, platinum-resistant ovarian cancer in patients treated with up to 3 prior therapies. This conversion to full approval was based on data from the confirmatory Phase III MIRASOL trial, where Elahere demonstrated an overall survival benefit and significantly reduce the risk of cancer progression.

    轉向腫瘤學,在本季度,我們完成了ImmunoGen 交易,該交易帶來了實體癌症和血癌令人興奮的項目。上個月,Elahere 獲得 FDA 的全面批准,用於治療多達 3 種既往療法的 FR α 陽性、鉑抗藥性卵巢癌患者。此次轉為完全批准是基於 MIRASOL 驗證性 III 期試驗的數據,其中 Elahere 證明了整體生存獲益,並顯著降低了癌症進展的風險。

  • We expect to see results from additional ImmunoGen programs this year, including data from the Phase II PICCOLO study evaluating Elahere as a monotherapy in FR alpha-positive, third-line plus, platinum-sensitive ovarian cancer patients who are not eligible for retreatment with platinum-based therapies. And we expect to see data in the second half of the year from a potentially registration-enabling Phase II trial for our CD123-targeting ADC PVEK in a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm.

    我們預計今年將看到更多的ImmunoGen計畫的結果,包括II期PICCOLO研究的數據,該研究評估了Elahere作為單一療法治療不符合鉑類復治資格的FR α陽性、三線+、鉑類敏感卵巢癌患者的情況為基礎的療法。我們預計將在今年下半年看到我們的 CD123 靶向 ADC PVEK 在一種稱為母細胞性漿細胞樣樹突狀細胞腫瘤的罕見血癌中進行的可能註冊的 II 期試驗的數據。

  • Now moving to program updates in hematologic oncology. Based on the totality of the data from our TRANSFORM-1 trial and following recent feedback from regulators, we will not be submitting navitoclax for approval in myelofibrosis, and we will wind down the TRANSFORM-2 study in the relapsed refractory setting. In other areas of hem/onc, we remain on track for several regulatory and clinical milestones this year, including regulatory approvals in the U.S. and Europe for a Epkinly in relapsed/refractory follicular lymphoma.

    現在轉向血液腫瘤學計畫更新。根據我們 TRANSFORM-1 試驗的全部數據以及監管機構最近的回饋,我們將不會提交 navitoclax 申請批准治療骨髓纖維化,並且我們將逐步結束針對復發難治性疾病的 TRANSFORM-2 研究。在血液/腫瘤的其他領域,我們今年仍有望實現多個監管和臨床里程碑,包括美國和歐洲監管機構批准 Epkinly 用於治療復發/難治性濾泡性淋巴瘤。

  • The Phase III readout from the VENCLEXTA VERONA trial in treatment-naïve, higher-risk MDS and initiation of a Phase III monotherapy study for ABBV-383 in third-line multiple myeloma. We remain very excited about this asset's potential to become a best-in-class BCMA CD3 bispecific by providing deep, durable responses and low incidence and severity of CRS with the potential for outpatient administration, limited or no step-up dosing and monthly administration from the beginning of treatment.

    VENCLEXTA VERONA 試驗針對未經治療的高風險 MDS 的 III 期讀數,以及針對 ABBV-383 三線多發性骨髓瘤的 III 期單藥治療研究的啟動。我們仍然對這項資產成為一流的BCMA CD3 雙特異性藥物的潛力感到非常興奮,因為它提供了深入、持久的反應以及CRS 的低發生率和嚴重程度,並且有可能進行門診給藥、有限或無需逐步劑量以及每月給藥。

  • Moving to other areas of our pipeline. In aesthetics, we remain on track to submit our regulatory application for BoNT/E in the second half of the year. Our rapid onset short-acting toxin as a highly differentiated clinical profile compared to currently available neurotoxins. BoNT/E is designed for patients that are considering using facial toxins for the first time or for a special event and will allow them to experience results over a very short period of time. This novel toxin will complement our existing business, as patients would naturally transition to Botox following experience with this trial toxin.

    轉移到我們管道的其他領域。在美學領域,我們仍有望在今年下半年向 BoNT/E 提交監管申請。與目前可用的神經毒素相比,我們的快速起效短效毒素具有高度差異化的臨床特徵。 BoNT/E 專為考慮首次使用臉部毒素或參加特殊活動的患者而設計,可讓他們在很短的時間內體驗到效果。這種新型毒素將補充我們現有的業務,因為患者在使用這種試驗毒素後會自然過渡到肉毒桿菌。

  • And in neuroscience, we continue to make good progress with 951, where we have received regulatory approvals in 33 countries thus far and anticipate an approval decision in the U.S. in the second quarter. As Rob mentioned, we remain on track to close the Cerevel transaction in the middle of this year. Cerevel recently announced positive top line results from their Phase III TEMPO-3 trial evaluating Tavapadon as adjunctive therapy to levodopa in patients with Parkinson's disease. In the study, Tavapadon met the primary endpoint, demonstrating a 1.1-hour increase in total on-time without troublesome dyskinesia compared to patients treated with levodopa and placebo.

    在神經科學領域,我們繼續在 951 方面取得良好進展,迄今為止我們已在 33 個國家獲得監管部門的批准,預計第二季在美國將做出批准決定。正如 Rob 所提到的,我們仍有望在今年年中完成 Cerevel 交易。 Cerevel 最近宣布了其 III 期 TEMPO-3 試驗的積極頂線結果,該試驗評估了 Tavapadon 作為左旋多巴輔助治療帕金森氏症患者的效果。在該研究中,Tavapadon 達到了主要終點,與接受左旋多巴和安慰劑治療的患者相比,Tavapadon 的總用藥時間增加了 1.1 小時,且沒有麻煩的運動障礙。

  • Tavapadon also met the key secondary endpoint in the trial, providing a significant reduction in off-time compared to levodopa and placebo. Two additional Phase III studies for Tavapadon in Parkinson's disease are expected to read out later this year. The emraclidine pivotal studies in schizophrenia remain on track to begin reading out later this year as well. We look forward to providing updates on these programs once the transaction has closed.

    Tavapadon 也達到了試驗中的關鍵次要終點,與左旋多巴和安慰劑相比,停工時間顯著減少。 Tavapadon 治療帕金森氏症的另外兩項 III 期研究預計將於今年稍後公佈。恩拉克定治療精神分裂症的關鍵研究仍有望在今年稍後開始宣讀。我們期待在交易結束後提供這些計劃的最新資訊。

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

    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, Roopal. Starting with our first quarter results. We reported adjusted earnings per share of $2.31, which is $0.11 above our guidance midpoint. These results include an $0.08 unfavorable impact from acquired IPR&D expense. Total net revenues were $12.3 billion, $400 million ahead of our guidance and reflecting a return to growth of 1.6% on an operational basis, excluding a 0.9% unfavorable impact from foreign exchange. Importantly, these results reflect more than 15% sales growth from our ex-Humira growth platform. The adjusted operating margin ratio was 42.2% of sales. This includes adjusted gross margin of 82.9%, adjusted R&D expense of 14.7%, acquired IPR&D expense of 1.3% and adjusted SG&A expense of 24.6%. Adjusted net interest expense was $429 million. The adjusted tax rate was 14.8%.

    謝謝你,魯帕爾。從我們第一季的業績開始。我們公佈的調整後每股收益為 2.31 美元,比我們的指導中位數高出 0.11 美元。這些結果包括收購的 IPR&D 費用帶來的 0.08 美元不利影響。總淨收入為 123 億美元,比我們的指引高出 4 億美元,反映出營運基礎上恢復了 1.6% 的成長,排除了 0.9% 的外匯不利影響。重要的是,這些結果反映了我們前 Humira 成長平台超過 15% 的銷售額成長。調整後的營業利益率為銷售額的42.2%。其中調整後毛利率為 82.9%,調整後研發費用為 14.7%,收購智慧財產權與研發費用為 1.3%,調整後銷售、一般管理費用為 24.6%。調整後淨利息支出為 4.29 億美元。調整後的稅率為14.8%。

  • Turning to our financial outlook. We are raising our full year adjusted earnings per share guidance to between $11.13 and $11.33. This increase of $0.16 at the midpoint includes $0.26 of operating overperformance, partially offset by $0.10 of higher dilution due to the earlier close of ImmunoGen. As previously communicated, this earnings per share guidance includes $0.42 of dilution related to the recently closed acquisition of ImmunoGen and the pending acquisition of Cerevel. Please also note that this guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the first quarter. We now expect total net revenues of approximately $55 billion, an increase of $800 million. At current rates, we expect foreign exchange to have a 0.9% unfavorable impact on full year sales growth.

    轉向我們的財務前景。我們將全年調整後每股盈餘指引提高至 11.13 美元至 11.33 美元之間。中間值增加 0.16 美元,其中包括 0.26 美元的營運超額表現,部分被 ImmunoGen 較早收盤導致的稀釋度提高 0.10 美元所抵消。如同先前所傳達的,此每股收益指引包括與最近完成的ImmunoGen 收購和即將收購Cerevel 相關的0.42 美元稀釋。另請注意,本指南不包括第一季之後可能發生的收購智慧財產權和研發費用的估計。我們現在預計總淨收入約為 550 億美元,增加 8 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 0.9% 的不利影響。

  • This revenue forecast includes the following updated assumptions with the entire sales increase driven by our ex-Humira growth platform. We now expect Skyrizi global revenue of $10.7 billion, an increase of $200 million due to strong momentum across all approved indications; Rinvoq total sales of $5.6 billion, an increase of $100 million, reflecting robust uptake in IBD; Imbruvica total revenue of $3.1 billion, an increase of $200 million, reflecting lower erosion; and Elahere total sales to AbbVie of $450 million, an increase of roughly $200 million, reflecting a partial year of revenue following the February close of the ImmunoGen acquisition.

    此收入預測包括以下更新的假設,整個銷售成長由我們的前 Humira 成長平台推動。我們目前預計 Skyrizi 全球收入將達到 107 億美元,由於所有已批准適應症的強勁勢頭,該收入將增加 2 億美元; Rinvoq 總銷售額達 56 億美元,增加 1 億美元,反映出 IBD 的強勁成長; Imbruvica 總收入為 31 億美元,增加了 2 億美元,反映侵蝕減少; Elahere 向 AbbVie 的總銷售額為 4.5 億美元,增加了約 2 億美元,反映了 2 月完成 ImmunoGen 收購後的部分年度收入。

  • Moving to the P&L for 2024. We continue to forecast adjusted gross margin of approximately 84% of sales, adjusted R&D investment of 14%, adjusted SG&A expense of 23.5% and an adjusted operating margin ratio of roughly 46.5%. We now expect adjusted net interest expense of $2.2 billion, which includes the partial year cost in 2024 to finance the ImmunoGen and Cerevel transactions.

    轉向2024 年的損益表 我們持續預測調整後的毛利率約為銷售額的84%,調整後的研發投資為14%,調整後的SG&A 費用為23.5%,調整後的營業利潤率約為46.5 %。我們現在預計調整後的淨利息支出為 22 億美元,其中包括 2024 年為 ImmunoGen 和 Cerevel 交易融資的部分年度成本。

  • Turning to the second quarter. We anticipate net revenues of approximately $14 billion, which includes U.S. Humira erosion of approximately 32%, reflecting a step-up in volume erosion with the recent CVS formulary change, partially offset by a onetime price benefit, also associated with that change. At current rates, we expect foreign exchange to have a 1.3% unfavorable impact on sales growth. We are forecasting adjusted operating margin ratio of approximately 49.5% of sales, and we are also modeling a non-GAAP tax rate of 16.4%. We expect adjusted earnings per share between $3.05 and $3.09. This guidance does not include acquired IPR&D expense that may be incurred in the quarter.

    轉向第二季。我們預期淨收入約為140 億美元,其中包括美國修美樂(Humira) 約32% 的侵蝕,反映出最近CVS 處方變更導致銷量侵蝕加劇,部分被同樣與該變化相關的一次性價格優勢所抵消。依照目前的匯率,我們預期外匯將對銷售成長產生 1.3% 的不利影響。我們預測調整後的營業利潤率約為銷售額的 49.5%,我們也對 16.4% 的非 GAAP 稅率進行建模。我們預計調整後每股收益在 3.05 美元至 3.09 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。

  • In closing, I'm very pleased with the excellent start to the year. We are demonstrating strong momentum across the portfolio, and our financial outlook remains very strong.

    最後,我對今年的良好開局感到非常滿意。我們的整個投資組合展現出強勁的勢頭,我們的財務前景仍然非常強勁。

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

    這樣,我會將電話轉回給莉茲。

  • Elizabeth Shea - SVP of IR

    Elizabeth Shea - SVP of IR

  • Thanks, Scott. (Operator Instructions) Operator, first question, please.

    謝謝,斯科特。 (操作員指示)操作員,第一個問題,請回答。

  • Operator

    Operator

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

    我們的第一個問題來自富國銀行的 Mohit Bansal。

  • Mohit Bansal - Senior Equity Analyst

    Mohit Bansal - Senior Equity Analyst

  • Congrats on the progress and congrats, Rob, as well. So maybe let's just start with 2024. I mean so thanks for this guidance. But when we look from 2024 to '25, there are a couple of headwinds that you have highlighted in the past. So obviously, IRA Part D redesign will be there and Humira may have another leg down. And given the volume erosion here, people are a little bit concerned there. Can you help us understand that what is your current thinking on the trough, '24 versus '25? And could you give us some confidence that you can continue to grow in '25 despite these headwinds from IRA and Humira?

    恭喜你所取得的進步,也恭喜羅布。所以也許我們就從 2024 年開始。但當我們展望 2024 年至 25 年時,您過去曾強調過一些不利因素。顯然,IRA D 部分將進行重新設計,修美樂 (Humira) 可能還會有另一條腿。考慮到這裡的體積侵蝕,人們有點擔心那裡。您能否幫助我們了解您目前對「24 與 25」低谷的看法是什麼?儘管存在 IRA 和 Humira 的不利因素,您能否給我們一些信心,讓我們相信您可以在 25 年繼續成長?

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • So Mohit, this is Rob. I'll take that question. So if you think about '24, '25, I mean, clearly, the ex-Humira growth platform is demonstrating great momentum. If you just think about Skyrizi and Rinvoq alone are growing by more than $4 billion per year. Aesthetics will recover to high single-digit growth. Our neuroscience franchise will grow by over $1 billion this year on the heels of strong momentum for Vraylar and our migraine portfolio, and we will have incremental contributions from VYALEV and Elahere in '25. So we have several drivers that will offset Humira erosion next year as well as the Part D benefit redesign impact and allow us to still deliver robust revenue growth.

    莫希特,這是羅布。我來回答這個問題。因此,如果你想想“24”、“25”,我的意思是,很明顯,前 Humira 成長平台正在展現出巨大的勢頭。如果你想想 Skyrizi 和 Rinvoq 每年的成長就超過 40 億美元。美學將恢復到高個位數成長。繼 Vraylar 和我們的偏頭痛產品組合的強勁勢頭之後,我們的神經科學特許經營今年將增長超過 10 億美元,並且我們將在 25 年獲得 VYALEV 和 Elahere 的增量貢獻。因此,我們有幾個驅動因素將抵消修美樂明年的侵蝕以及 D 部分福利重新設計的影響,並使我們仍然能夠實現強勁的收入成長。

  • When you think about that redesign impact, it will really spread across our business, most concentrated in immunology and oncology. And we would estimate that, that total revenue impact could be worth several points of growth. While we'll still deliver robust revenue growth, we will have that headwind in '25. But keep in mind, for us, the IRA impact really hits us in '25 and isn't a significant headwind in the years that follow, as products that are subject to negotiation will not have that Part D cost share impact. So the way to think about it is despite that headwind in '25, we will still deliver robust growth, with that growth rate accelerating in the years that follow.

    當你想到重新設計的影響時,它確實會蔓延到我們的整個業務,最集中在免疫學和腫瘤學領域。我們估計,總收入影響可能值得幾個百分點的成長。雖然我們仍將實現強勁的收入成長,但我們將在 25 年遇到這種阻力。但請記住,對我們來說,IRA 的影響在25 年確實對我們產生了影響,並且在接下來的幾年裡並不是一個重大的阻力,因為需要談判的產品不會產生D 部分成本分攤的影響。因此,我們的思考方式是,儘管 25 年遇到了逆風,我們仍將實現強勁增長,並且在接下來的幾年中增長率會加快。

  • And then if you think about on a margin perspective, we're going to continue to expand operating margins. So that will be a tailwind. You should be though modeling annualization of interest expense from these transactions. And keep in mind that we essentially would have -- think of it as a roughly half year for Cerevel and 10.5 months this year for ImmunoGen. So that should be something that you do model for '25. So we'll have robust revenue growth. We'll have earnings growth, not quite at the rate of the revenue growth because of that annualization impact. But then when you get to '26 and beyond, you have even faster revenue growth and very robust earnings growth. So that's probably the best way to think about the profile of the company. But when you look at that ex-Humira growth platform, there's a lot of momentum there, and we are very well positioned to deliver very robust growth.

    然後,如果你從利潤率的角度考慮,我們將繼續擴大營業利潤率。所以這將是一個順風。您應該對這些交易的利息支出進行年化建模。請記住,我們基本上會將 Cerevel 視為大約半年,而今年的 ImmunoGen 則視為 10.5 個月。所以這應該是你為 25 年做的模型。因此,我們將實現強勁的收入成長。由於年化影響,我們將實現獲利成長,但不會完全達到收入成長的速度。但當你到了 26 歲及以後,你的收入成長會更快,獲利成長也會非常強勁。因此,這可能是考慮公司概況的最佳方式。但是,當你看到前 Humira 成長平台時,你會發現那裡有很大的動力,而且我們處於非常有利的位置,可以實現非常強勁的成長。

  • Operator

    Operator

  • The next question is from Vamil Divan with Guggenheim.

    下一個問題來自古根漢的瓦米爾·迪萬。

  • Vamil Kishore Divan - MD of Healthcare Research & Senior Equity Research Analyst

    Vamil Kishore Divan - MD of Healthcare Research & Senior Equity Research Analyst

  • So maybe I could just ask a couple on the aesthetics side. It sounds like your commentary is pretty generally in line with what you said before, but obviously, the number was a little lighter this quarter than even your guidance on what people are expecting. So can you maybe just talk a little bit more about that? You mentioned some shift in promotional efforts to the second quarter and maybe inventory levels then as a result being lower, and maybe I don't know if you can quantify that a little bit. And was this sort of planned when you gave your guidance back in February? Or is this something that's sort of evolved over the course of the quarter? Maybe just kind of why the decision, maybe it would be helpful to give us some comfort on the outlook there.

    所以也許我可以問一些美學上的問題。聽起來您的評論與您之前所說的基本一致,但顯然,本季度的數字甚至比您對人們預期的指導要少一些。那你能多談談這個嗎?您提到第二季促銷工作發生了一些轉變,可能導致庫存水準降低,也許我不知道您是否可以對此進行量化。當您在二月提供指導時,這是有計劃的嗎?或者這是本季發生的一些變化?也許這只是為什麼做出這個決定,也許這會讓我們對那裡的前景感到一些安慰。

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

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

  • This is Carrie. Thanks for the question. So first, I'll give a little bit of context to the fundamentals in terms of market growth and market share, which were in line with our expectations. So our market share continues to be strong and stable. For Botox Cosmetic, despite a new competitor, strong stable share at high levels. And then for our Juvederm line, continued share strength, even some share pickup in the past few quarters as we launch our new products. So like you said, those fundamentals are in line with our expectations.

    這是嘉莉。謝謝你的提問。首先,我將介紹市場成長和市場佔有率的基本面背景,這符合我們的預期。因此,我們的市場份額持續保持強勁和穩定。對於Botox Cosmetic來說,儘管有新的競爭對手,但市佔率仍保持在高水準。然後,對於我們的 Juvederm 系列,份額持續強勁,甚至在過去幾個季度,隨著我們推出新產品,份額有所回升。正如您所說,這些基本面符合我們的預期。

  • As we were going through the quarter, we really realized that the aesthetics market is quite sensitive to seasonality with Q2 and Q4 typically having the highest volume. And after a few years of COVID and economic disruption, we're now anticipating a return to that typical seasonality. So we shifted investment in some of our sales and marketing efforts into Q2, which impacted customer and sales promotional timing and activities, which then resulted in lower inventory held by our customers in Q1. And we do expect that to come back in Q2 and the rest year.

    當我們經歷這個季度時,我們真正意識到美容市場對季節性非常敏感,第二季和第四季的交易通常最高。經過幾年的新冠疫情和經濟混亂,我們現在預計會回到那種典型的季節性。因此,我們將部分銷售和行銷工作的投資轉移到第二季度,這影響了客戶和銷售促銷時間和活動,從而導致第一季客戶持有的庫存減少。我們確實預計這種情況會在第二季和餘下的一年中恢復。

  • And I'll let Scott address the rest of that question.

    我將讓斯科特回答這個問題的其餘部分。

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Sure. Thanks, Carrie. So Vamil, to quantify the inventory impact in the first quarter, it was a little bit more than $50 million between Juvederm and Botox. And you can think of that as being split roughly 2/3 to Botox and 1/3 to Juvederm. And I think as Carrie mentioned in her remarks, that impact of that inventory will -- we expect that to turn in the second quarter.

    當然。謝謝,嘉莉。因此,Vamil 量化了第一季的庫存影響,Juvederm 和 Botox 之間的成本略高於 5,000 萬美元。您可以將其視為大約 2/3 分配給 Botox,1/3 分配給 Juvederm。我認為,正如嘉莉在她的演講中提到的那樣,庫存的影響將——我們預計這種影響將在第二季扭轉。

  • Operator

    Operator

  • The next question comes from Chris Shibutani with Goldman Sachs.

    下一個問題來自高盛的 Chris Shibutani。

  • Chris Shibutani - Research Analyst

    Chris Shibutani - Research Analyst

  • Great. When we think about the 2024 upcoming contracting season, which obviously has been quite dynamic for Humira over the past year plus, can you provide us with any insights in terms of structural aspects within your contracts that you build in that may help provide offsets? We often have limited visibility. We're looking at the prescription volume trends, and it feels as if our calculus is sometimes incomplete. But what can you reassure us in terms of the dynamics as we're seeing this year to play out and how you're approaching contracting for the forward?

    偉大的。當我們考慮即將到來的 2024 年合約季節時,修美樂在過去一年中顯然非常活躍,您能否向我們提供有關您合約中結構方面的任何見解,這些見解可能有助於提供補償?我們的能見度常常有限。我們正在研究處方量趨勢,感覺我們的計算有時是不完整的。但是,就今年我們所看到的動態以及您如何處理前鋒合約而言,您能向我們保證什麼嗎?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Chris, it's Jeff. So the contracting season typically starts April or May. And frankly, as we've highlighted before, can run in the immunology category really through the end of the year. So we have a few philosophies that we look towards, which are we want to continue to basically make sure that patients, if possible, based on our pricing concessions aren't disrupted because when you start to disrupt patients, they do struggle with the change. It's a change in their treatment course. And so as we look to that, we've historically highlighted that we are negotiating for parity contracts with Humira. And we do put some controls in place in some cases, but not all. We seek multiyear contracts with our payers to try to establish the relationship, the pricing, et cetera. And we will think of ways to make sure that those contracts can hold. So they have some teeth in them. They can't just be willy-nilly discarded. And so it is a long term, in some cases, partnership over a couple of years with these payers.

    克里斯,這是傑夫。因此,合約季節通常從四月或五月開始。坦白說,正如我們之前所強調的那樣,免疫學類別確實可以運行到今年年底。因此,我們有一些我們所追求的理念,即我們希望繼續基本上確保患者(如果可能的話)基於我們的定價優惠不會受到干擾,因為當你開始乾擾患者時,他們確實會為這種變化而掙扎。這是他們治療過程的改變。因此,當我們考慮這一點時,我們歷來強調我們正在與 Humira 就平價合約進行談判。我們確實在某些情況下採取了一些控制措施,但不是全部。我們尋求與付款人簽訂多年期合同,以嘗試建立關係、定價等。我們會想辦法確保這些合約能夠有效。所以他們裡面有一些牙齒。它們不能被隨意丟棄。因此,在某些情況下,與這些付款人是幾年的長期合作關係。

  • I can't go into the details over exactly how those controls work. But suffice it to say that there's terms and timing and limits in terms of when contracts can be changed, even maybe some clawbacks in some cases. So because we want these more sustained relationships because of our position in the category with these great brands, we typically use those sort of techniques, and that's how we go for it. So again, it's hard to look forward too much because it is dynamic as we look to '25. But we've been quite successful in maintaining good access for our brands and certainly, Humira is tracking in line with our expectations.

    我無法詳細說明這些控制項的工作原理。但只要說一下,合約的變更是有條款、時間和限制的,甚至在某些情況下可能會有一些回扣。因此,因為我們希望與這些偉大品牌在該類別中的地位建立更持久的關係,所以我們通常使用這些技術,而這就是我們的做法。再說一次,我們很難對未來抱持太多期待,因為當我們展望 25 世紀時,它是充滿活力的。但我們在保持我們品牌的良好准入方面非常成功,當然,Humira 的追蹤符合我們的預期。

  • 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 a couple more on the Humira front. I think in Humira, you had mentioned that in 2024, you expected most of the impact would be price versus volume. But I think The Street has been concerned that we're seeing more volume erosion, particularly with the CVS book of business. I'm just interested in your latest thinking as we think about price versus volume for the remainder of this year. As we consider CVS, Cigna, et cetera, how should we think about that balance just so there's kind of surprises as, I guess, we watch these volume trends playing out? And then maybe just on a related topic, can you talk at all about the tail for Humira sales in the U.S.? I guess [the heart of] the question, do you expect that you'll see most players or payers eventually switch out Humira like we're seeing at CVS? And if so, is it still reasonable to think about there being a kind of a decent tail of revenue, I guess, for this product in the U.S. over time?

    Humira 方面還有一些。我想在 Humira 中,您曾提到,到 2024 年,您預計大部分影響將是價格與銷售。但我認為華爾街一直擔心我們會看到更多的交易量下降,尤其是 CVS 的業務。我只是對您的最新想法感興趣,因為我們正在考慮今年剩餘時間的價格與數量。當我們考慮 CVS、Cigna 等公司時,我們應該如何考慮這種平衡,以便在我們觀察這些成交量趨勢的發展時會出現一些意外?然後也許只是在一個相關的話題上,您能談談 Humira 在美國銷售的尾巴嗎?我想問題的核心是,您是否期望大多數玩家或付款人最終會像我們在 CVS 看到的那樣放棄 Humira?如果是這樣,我想,隨著時間的推移,該產品在美國會有一個不錯的收入尾部,這樣的想法是否仍然合理?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. Great question. There's a lot in there. Let me go through it in a systematic fashion. So I think, first, to directly answer your question. We still, as we look forward, believe that the significant majority of our lives will be at parity. So that means our guidance around the majority being price is still holding in our go-forward look. Let me give you some perspective. I had some in my opening remarks over what's happening with CVS. So the first is that, as I mentioned, the step-down in volume was really anticipated. And based on our analysis of the data, which I'll highlight, it's really right in line with our expectations.

    是的。很好的問題。裡面有很多東西。讓我有系統地講一下。所以我想,首先,直接回答你的問題。展望未來,我們仍然相信,我們生活的大部分時間將保持平等。因此,這意味著我們對價格的指導仍然是我們的未來展望。讓我給你一些觀點。我在開場白中談到了 CVS 的情況。首先,正如我所提到的,成交量的下降確實是預料之中的。根據我們對數據的分析(我將強調這一點),它確實符合我們的預期。

  • Now one of the things in my remarks, I often talk about new to brand or our in-play share capture, and that's a really good way to look at performance, particularly early in launch cycles when you're looking at capture rate or competitive dynamics. I think it's important that investors and analysts need to be very mindful. When you have a dislocation or disruption or switching, you can get very, very fooled at looking at NRx or NBRx because it sort of overinflates what you might be looking at. So I think that's important.

    現在,我的演講中的一件事是,我經常談論品牌新事物或我們在遊戲中的份額捕獲,這是查看性能的一個非常好的方法,特別是在發布週期的早期,當您考慮捕獲率或競爭力時動力學。我認為投資者和分析師需要非常謹慎,這一點很重要。當您遇到錯位、中斷或切換時,您可能會因為查看 NRx 或 NBRx 而感到非常非常愚蠢,因為它有點誇大了您可能正在查看的內容。所以我認為這很重要。

  • The other fact base that we look at is in terms of the step-down is we look at other analogs, and we look at the COSENTYX Taltz analog or Taltz was advantaged in ESI for COSENTYX back in 2019. And we see that typically in this category, almost 90% of the erosion tracks within the first 2 to 3 weeks. And that's actually what we're starting to see, we believe, with the CVS template following that similar pattern.

    我們研究的另一個事實基礎是在降壓方面,我們研究了其他類似物,我們研究了 COSENTYX Taltz 類似物,或者 Taltz 在 2019 年的 COSENTYX 的 ESI 中具有優勢。幾乎90% 的侵蝕是在前2 至3 週內發生的。我們相信,這實際上是我們開始看到的,CVS 模板也遵循類似的模式。

  • So if you can't really look at NRx or NBRx, you really have to look at TRx in this case, Chris. And this is very interesting. And we would make sure to guide folks to look at what's happening with the TRx data in the market. And what we see is that not all of the Humira prescriptions are moving to a biosimilar. And if you look at the first 2 weeks, it's pretty meaningful. Over 20% of the Humira prescriptions are moving to other mechanisms of actions, including Skyrizi and Rinvoq. And in fact, while we haven't studied this week as much, it actually seems to have accelerated a bit from there. And that actually makes some sense because if you think it from the physician's perspective, when patients are being switched, they often take a break in a pause to say, "Are these patients really under control? Should I consider an alternative." And that's actually what we see playing out in the market.

    因此,如果您無法真正查看 NRx 或 NBRx,那麼在這種情況下您確實必須查看 TRx,Chris。這很有趣。我們將確保引導人們了解市場上 TRx 數據的情況。我們看到的是,並非所有 Humira 處方都轉向生物相似藥。如果你看看前兩週,你會發現這是非常有意義的。超過 20% 的 Humira 處方正在轉向其他作用機制,包括 Skyrizi 和 Rinvoq。事實上,雖然我們本週沒有研究那麼多,但實際上似乎從那時起有所加速。這其實是有一定道理的,因為如果你從醫生的角度思考,當病人被調換時,他們經常會停下來問,「這些病人真的得到控制了嗎?我應該考慮另一種選擇嗎? 」這實際上就是我們在市場上看到的情況。

  • So the pure degradation or step-down from Humira is in line with what we see, but we are seeing a fairly significant move to other mechanisms, as I mentioned, including our own Skyrizi and Rinvoq.And that could be very, very good for patients who are probably getting better care for control of their disease. Now having said that as well, if we look through the rest of '24, we have very solid contracts with our payers through 2024. And remember that these payers can add biosimilars at parity whenever they choose. We saw that last year in the middle of the year, and that's really not different now. So when we look at the structure and controls of our existing agreements, we do not see widespread exclusions for the rest of the year as we go forward. And so I think we've been pretty consistent with that, that select clients will move towards biosimilars over the course of the year.

    因此,Humira 的純粹退化或降級與我們所看到的一致,但正如我所提到的,我們看到其他機制的相當重大的轉變,包括我們自己的 Skyrizi 和 Rinvoq。得到更好的照護以控制疾病的患者。現在話雖如此,如果我們回顧 24 年剩餘的時間,我們與付款人之間的合約非常牢固,直到 2024 年。我們去年年中就看到了這一點,現在也沒什麼不同。因此,當我們審視現有協議的結構和控制措施時,我們並沒有看到今年剩餘時間出現廣泛的排除。因此,我認為我們的觀點非常一致,即精選客戶將在今年內轉向生物相似藥。

  • Last year, we saw that with Kaiser and Medicaid plans. We talked about the CVS exclusion for the template business. And we do see that some select plans may take another approach, which we've contemplated as the year goes on, which is they may move new patients to the biosimilar, but maintain the large existing base. And that's quite manageable because really only about 14% or 15% of the patients are new patients that cycle into Humira. So overall, that's our perspective. We're confident things are tracking in line. We're quite interested in this shift to other mechanisms, which is frankly somewhat anticipated, but maybe operating a little higher than we thought. And we still believe that a significant majority of Humira will sit at parity lives in '24.

    去年,我們在凱撒和醫療補助計劃中看到了這一點。我們討論了模板業務的 CVS 排除。我們確實看到一些選定的計劃可能會採取另一種方法,隨著時間的推移,我們已經考慮過這種方法,即他們可能會將新患者轉移到生物仿製藥,但保持現有的龐大基礎。這是相當容易控制的,因為實際上只有大約 14% 或 15% 的患者是循環使用 Humira 的新患者。總的來說,這就是我們的觀點。我們有信心一切都在按部就班地進行。我們對向其他機制的轉變非常感興趣,坦白說,這在某種程度上是預料之中的,但可能運作得比我們想像的要高一些。我們仍然相信,絕大多數 Humira 將在 24 年實現同等生活。

  • Tail. Oh, the tail. Okay. So the tail, we're going to be negotiating '25. And what we've highlighted is we are going to watch exactly how the interchangeables play out. We think we've got a good understanding of that. And so it will probably become more apparent as we move through '25 where that tail may sit. And we've highlighted that it may start to emerge in '25 and probably be much more visible by '26. And that's going to ultimately depend on how, over the course of '25, the price volume fully plays out in the marketplace.

    尾巴。哦,尾巴。好的。所以最後,我們將在 25 年進行談判。我們強調的是,我們將觀察可互換產品的具體表現。我們認為我們對此已經有了很好的理解。因此,當我們進入 25 年時,它可能會變得更加明顯。我們已經強調,它可能會在 25 年開始出現,到 26 年可能會更加明顯。這最終將取決於 25 年期間價格量如何在市場上充分發揮作用。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • And Chris, this is Rob. On your question regarding the guidance for this year. I think it's important to note, yes, we've said that the vast majority of the erosion is price. We've talked about that dynamic. If you think about first half, second half, we have the annualization impact given the midyear step-up in rebates last year. So the annualization impact comes through in the first half, you'd expect price erosion to be greater in the first half or the second half. But at the same time, we did contemplate volume erosion because we were very well aware of the CVS contract. We gave you that guidance. And so we have contemplated that volume erosion, but that's more of a second half versus first half as well as the potential for we knew that interchangeable coming in, there could be some marginal amount of volume pickup there. So we did put in volume erosion in our guidance, but the vast majority of it is price, but I don't want investors to think that we didn't put any volume into our guidance. We were very well aware of the CVS contract. And I think we made some prudent assumptions on potentially other impacts. But overall, we're still tracking in line with that guidance.

    克里斯,這是羅布。關於你提到的今年指導意見的問題。我認為值得注意的是,是的,我們已經說過,絕大多數的侵蝕是價格。我們已經討論過這種動態。如果您考慮上半年和下半年,考慮到去年年中回扣的增加,我們會產生年化影響。因此,年化影響會在上半年顯現,您預計上半年或下半年的價格侵蝕會更大。但同時,我們確實考慮了交易量的侵蝕,因為我們非常了解 CVS 合約。我們給了你這樣的指導。因此,我們已經考慮到了銷量的下降,但這更多的是下半年與上半年的情況,以及我們知道可互換產品進入的潛力,那裡的銷量可能會有一些邊際回升。因此,我們確實在指引中加入了成交量侵蝕,但其中絕大多數是價格,但我不希望投資者認為我們沒有在指引中加入任何成交量。我們非常了解 CVS 合約。我認為我們對潛在的其他影響做出了一些謹慎的假設。但總體而言,我們仍在按照該指導進行追蹤。

  • Operator

    Operator

  • Our next question comes from Terence Flynn with Morgan Stanley.

    我們的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

  • Congrats to Rick, and best of luck to Rob in the new role. Just wondering if you could maybe frame a little bit for us the opportunity for Skyrizi in UC versus Crohn's disease. I think last time, we heard from J&J, Crohn's represented about $7 billion of Stelara sales. Obviously, you guys have made decent inroads there based on your comments. But just wondering how to think about the dollar opportunity in ulcerative colitis.

    恭喜 Rick,並祝 Rob 在新職位上好運。只是想知道您是否可以為我們介紹一下 Skyrizi 在 UC 與克羅恩病中的機會。我想上次我們從強生那裡聽說,克羅恩病的 Stelara 銷售額約為 70 億美元。顯然,根據您的評論,您已經在這方面取得了不錯的進展。但只是想知道如何看待潰瘍性結腸炎的美元機會。

  • And then when you were talking through some of the latest Rinvoq data, I was just wondering if there's an opportunity down the road as you generate more clinical data, but also commercial data to potentially revisit the restrictions on line of therapy on the label at some point. Or if we shouldn't think about that as a possibility.

    然後,當您討論一些最新的 Rinvoq 數據時,我只是想知道,隨著您產生更多臨床數據以及商業數據,是否有機會在某些時候重新審視標籤上治療系列的限制觀點。或者我們是否不應該考慮這種可能性。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. Thanks, Terence. It's Jeff. I'll take the first question. So Crohn's is larger than UC. I mean if you look at the overall market or revenue, I think it's 65%, 70%. So it's -- Crohn's is very, very significant. Having said that, ulcerative colitis is a multibillion-dollar opportunity for us. It's still a very, very underpenetrated and substantial indication. So it's weighted about 65-35, 70-30, but still, I wouldn't underestimate what ulcerative colitis means.

    是的。謝謝,特倫斯。是傑夫。我來回答第一個問題。所以克隆氏症比 UC 更大。我的意思是,如果你看一下整體市場或收入,我認為是 65%、70%。所以克隆氏症非常非常重要。話雖如此,潰瘍性結腸炎對我們來說是一個價值數十億美元的機會。這仍然是一個非常非常未充分滲透和實質的跡象。所以它的權重約為 65-35、70-30,但我仍然不會低估潰瘍性結腸炎的意義。

  • And I think I would add in concert with my prepared remarks, we've seen very, very significant acceleration into frontline Crohn's disease with Skyrizi. And what's remarkable, we studied a very, very difficult population in ulcerative colitis, but we still had substantial amount of naïve patients. And the performance in that naïve population is exceptional. I mean it is at the very, very top of the league table in terms of overall ability to get to endoscopic clearance and symptom control.

    我想我想補充一點,與我準備好的發言一致,我們已經看到 Skyrizi 在克羅恩病一線的進展非常非常顯著。值得注意的是,我們研究了患有潰瘍性結腸炎的非常非常困難的人群,但我們仍然有大量的初治患者。在那些天真的人群中,表現非常出色。我的意思是,就內視鏡清除和症狀控制的整體能力而言,它處於排行榜上非常非常靠前的位置。

  • And so we like that setup because, obviously, we have exactly the same representatives who are establishing the Crohn's indication in frontline, and we know that we can bring UC very fast afterwards when we get the approval this year. So it's a substantial global opportunity. Not the size that we'll see over the LRP with Crohn's, but still one of our largest opportunities that we have in the category. And I'll ask Roopal, based on the safety data he highlighted, to comment on the second question.

    所以我們喜歡這種設置,因為顯然,我們有完全相同的代表在前線建立克羅恩病適應症,而且我們知道,當我們今年獲得批准時,我們可以很快推出 UC。因此,這是一個巨大的全球機會。雖然不是我們在克羅恩病 LRP 上看到的規模,但仍然是我們在這個類別中擁有的最大機會之一。我將請魯帕爾根據他強調的安全數據對第二個問題發表評論。

  • Roopal Thakkar - Senior VP & Chief Medical Officer of Global Therapeutics

    Roopal Thakkar - Senior VP & Chief Medical Officer of Global Therapeutics

  • Yes. Thank you. So the data we keep generating continues to at least drive confidence for sure that the original Phase III that came out with their safety profile, and what we continue to learn even with longer-term data, even in more high-risk patients, confirms what we've always seen. And that will continue to drive confidence, I think, with our clinicians.

    是的。謝謝。因此,我們不斷產生的數據至少會繼續增強人們的信心,確保最初的III 期試驗的安全性,以及我們在長期數據(即使是在更高風險的患者中)中繼續了解到的內容,證實了這一點我們一直都看到。我認為,這將繼續增強我們臨床醫生的信心。

  • Now from a health authority standpoint, I think the position there is that you have this oral surveillance study with tofacitinib, and they're going to apply those findings to the other assets in a similar class probably until there's another outcome study to sort of argue against that. That's kind of how we see it. Now that's in the U.S. I would say globally, there's still an opportunity for many jurisdictions where JAK inhibitors can be at parity. So you might start seeing some more movement there in earlier lines.

    現在,從衛生當局的角度來看,我認為目前的情況是,您對託法替布進行了這項口服監測研究,他們將把這些發現應用於類似類別的其他資產,可能直到有另一項結果研究可以爭論為止反對這一點。我們就是這麼看的。我想說的是,現在在美國,在全球範圍內,許多司法管轄區仍然有機會實現 JAK 抑制劑的平等。所以你可能會開始在前面的線路中看到更多的動作。

  • But as Jeff stated in his prepared remarks, the second line and even third line of many of these indications continues to grow as people now have options where in the past, if all you had was a TNF, maybe you were cycling. But now that you know that there's other therapies, you're starting to see people break sooner. So I think that second and third line is still a huge opportunity, and we'll continue to grow with this emerging data.

    但正如傑夫在他準備好的演講中所說,隨著人們現在有選擇,其中許多適應症的第二線甚至第三線繼續增長,而在過去,如果你只有 TNF,也許你正在騎自行車。但既然你知道還有其他療法,你就會開始看到人們更快崩潰。所以我認為二線和三線仍然是一個巨大的機會,我們將隨著這些新興數據繼續成長。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • And Terence, it's Jeff again. One more comment. I mentioned how we're excited about the naïve position for both Skyrizi, CD and UC coming. But what's also nice is those same representatives are in the office and are able to highlight basically a one-two punch, where you use Skyrizi first in earlier lines based on this exquisite data. And then obviously, for later lines, you can use Rinvoq. And so we actually see in the marketplace that, that combination and that positioning is allowing us right now in real time, capturing almost towards 40% of all in-play share with Skyrizi first and Rinvoq second. So it's an encouraging position as we fill out that portfolio.

    特倫斯,又是傑夫。還有一則評論。我提到我們對 Skyrizi、CD 和 UC 的幼稚定位感到非常興奮。但同樣好的一點是,這些代表在辦公室裡,能夠突出顯示基本上是一打二拳,您可以根據這些精美的數據在早期的線路中首先使用 Skyrizi。顯然,對於後面的行,您可以使用 Rinvoq。因此,我們實際上在市場上看到,這種組合和定位使我們現在能夠即時獲得幾乎 40% 的遊戲份額,其中 Skyrizi 第一,Rinvoq 第二。因此,當我們填寫該投資組合時,這是一個令人鼓舞的位置。

  • Operator

    Operator

  • The next question comes from Carter Gould with Barclays.

    下一個問題來自巴克萊銀行的卡特·古爾德。

  • Carter Lewis Gould - Senior Analyst

    Carter Lewis Gould - Senior Analyst

  • I wanted to circle back on the prior commentary around some of the TRx data. And I guess the overarching question is, is that, I guess, appropriately kind of capturing all the volume you're really seeing? And just clearly, with your part of your agreement with CVS and the Cordavis there, there is the potential for some Humira volume to potentially be shifting there. Is that being captured by TRx? So I guess any commentary there on sort of the accuracy of that data that we're all seeing. And then maybe if you just go back and I wanted to circle back on the EPS commentary on '25, sort of the way you framed that growth, is that sort of ex IPR&D? Any color there would be appreciated.

    我想回顧一下之前對一些 TRx 數據的評論。我想最重要的問題是,我想,這是否適當地捕捉了您真正看到的所有體積?很明顯,根據您與 CVS 和 Cordavis 的協議,部分 Humira 的銷售有可能轉移到那裡。這是被 TRx 捕獲的嗎?所以我想對我們所看到的數據的準確性有任何評論。然後也許如果你回去,我想回顧一下 25 年的 EPS 評論,就像你描述增長的方式一樣,這屬於前知識產權與發展嗎?任何顏色都會受到讚賞。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. It's a great question. So it's early, but we believe the data is accurate. I mean if you look at the first 2 weeks to give you some sense, and this is inclusive of the Cordavis Humira. There was a downdraft of about 13,000 prescriptions for Humira from baseline. And the biosimilars captured about -- which was primarily the Cordavis HYRIMOZ captured about 10. So there's 3,000 prescriptions or over 20% that we can see in our data moving to other mechanisms of action, including our Skyrizi and Rinvoq.

    是的。這是一個很好的問題。所以現在還為時過早,但我們相信數據是準確的。我的意思是,如果你看看前兩週會給你一些感覺,這包括 Cordavis Humira。與基線相比,修美樂的處方數量減少了約 13,000 個。捕獲的生物相似藥——主要是 Cordavis HYRIMOZ 捕獲了大約 10 個。

  • And again, it's very logical because this is just not a one-to-one type of switch, like these physicians are interviewing and discussing with patients their care path forward. And so we think that clearly, some are moving to other mechanisms, and we've seen that in other analogs as well. So we believe the data is accurate. Again, it's early. We're going to continue to monitor it. Where that ultimately lands, we'll have to see. Again, I want to reiterate the pure Humira downdraft is within line with what we assumed, and we are seeing this other market behavior that's taking place.

    再說一遍,這是非常合乎邏輯的,因為這不是一對一類型的轉換,就像這些醫生正在採訪患者並與患者討論他們的護理路徑一樣。因此,我們認為顯然,一些機制正在轉向其他機制,我們也在其他類似機制中看到了這一點。所以我們相信數據是準確的。再說一遍,時間還早。我們將繼續對其進行監測。最終會落到哪裡,我們拭目以待。我想再次重申,修美樂的純粹下降符合我們的假設,我們正在看到正在發生的其他市場行為。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • And Carter, this is Rob. Just to clarify my earlier comments. Yes, it is ex IPR&D. We always guide to ex IPR&D. What I was trying to highlight is you should expect robust revenue growth in '25, and that growth accelerating in '26 and beyond given that Part D benefit redesign impact in '25. And given that operating margin will expand, you typically would expect our earnings to grow faster than our revenue. And that is generally true with one exception in '25 being that we will have an annualization impact from net interest expense. We will still deliver at a very solid earnings growth. But as you model it, just keep in mind that while you expect typically earnings to outpace revenue growth given expanding operating margin, you do have that dynamic in '25 that's important for your modeling.

    卡特,這是羅布。只是為了澄清我之前的評論。是的,它是前 IPR&D。我們始終引導前知識產權與發展。我想強調的是,考慮到 D 部分福利重新設計對 25 年的影響,您應該預期 25 年的收入將強勁增長,並且 26 年及以後的增長將加速。鑑於營業利潤率將會擴大,您通常會預期我們的收益成長速度快於營收成長速度。這通常是正確的,但 25 年有一個例外,那就是我們將受到淨利息支出的年化影響。我們仍將實現非常穩健的獲利成長。但在建模時,請記住,雖然您預計由於營業利潤率不斷擴大,收益通常會超過收入成長,但 25 年確實存在這種動態,這對您的建模很重要。

  • Operator

    Operator

  • Our next question comes from Simon Baker with Redburn Atlantic.

    我們的下一個問題來自 Redburn Atlantic 的 Simon Baker。

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • Two quick ones, if I may. Just going back to Humira, but in a slightly broader sense. There's been a degree of political noise around the role of PBMs in blocking or rather than assisting biosimilar uptake. I just wondered if you expect that to come to anything in terms of structural changes within the market? And then secondly, on Rinvoq and the LEVEL UP deal -- LEVEL UP data. I wonder how you see the competitive dynamics evolving in that space? Is this about switches? Or is this about market expectation -- expansion? I asked because this morning, Sanofi said that they welcome competition as a way of expanding the number of people treated in an area that's still relatively unpenetrated. So I just wonder how you see the opportunity commercially.

    如果可以的話,兩個快點。回到修美樂(Humira),但是在更廣泛的意義上。關於 PBM 阻止或促進生物相似藥的採用的作用存在一定程度的政治噪音。我只是想知道您是否期望這會帶來市場結構性變化?其次,關於 Rinvoq 和 LEVEL UP 交易-LEVEL UP 資料。我想知道您如何看待該領域的競爭動態?這是關於開關的嗎?或者這與市場預期——擴張有關?我之所以問這個問題,是因為今天早上,賽諾菲表示,他們歡迎競爭,以此作為擴大在一個相對未普及的領域接受治療的人數的一種方式。所以我只是想知道你如何看待這個商業機會。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. Thank you for the questions. It's Jeff again. I would say that we're not anticipating like a wholesale restructure of the PBM industry, for example. I mean we certainly think that there's very reasonable chance of sort of transparency reform, exactly how some of the economics are working, maybe transparencies to the government or downstream to the clients. That's very possible. But a major wholesale change, we don't see that happening in the near term. Obviously, we are continuing to monitor that and would make adjustments as we might need to.

    是的。謝謝你的提問。又是傑夫。例如,我想說的是,我們並不期望對 PBM 產業進行大規模重組。我的意思是,我們當然認為存在非常合理的機會進行某種透明度改革,確切地說,某些經濟學是如何運作的,也許是對政府或下游客戶的透明度。這很有可能。但我們認為短期內不會有重大的整體變化。顯然,我們正在繼續監控這一情況,並將根據需要進行調整。

  • Regarding your atopic dermatitis question, I think the answer is really a bit of both. I think as we've highlighted before, the market here is exceptional in terms of the low bio penetration or oral and bio penetration. It's really only about 4% or 5%. So I think Sanofi's comments are very well timed. I mean this marketplace is going to grow significantly as this innovation is able to be delivered to the global population with this very serious disease. But we also think this LEVEL UP study is good for our market share penetration, and I'll give you some perspective.

    關於你的異位性皮膚炎問題,我認為答案實際上是兩者兼而有之。我認為正如我們之前強調的那樣,這裡的市場在生物滲透率低或口服和生物滲透率方面非常出色。實際上只有 4% 或 5% 左右。所以我認為賽諾菲的評論非常及時。我的意思是,隨著這項創新能夠為全球患有這種非常嚴重疾病的人們提供服務,這個市場將會顯著成長。但我們也認為這項 LEVEL UP 研究有利於我們的市佔率滲透,我會給你一些觀點。

  • Our U.S. market share is lower. It's around 9%. So typically, where our countries have been able to highlight more direct comparisons, we couldn't do that because of the starting dose I highlighted. We see that most of our international affiliates have market shares in the mid-teens, in some cases in the low 20s. And so the ability to bring a comparative study that's directly linked to the U.S. label and show the physicians how you can get to higher levels of control. And really, patients want -- they want no disease on their skin and they really don't want itch if they can get there. And that's what we studied in LEVEL UP. So we think it's certainly going to help with both market expansion and in particular, around the world with our ability to capture some more share. So I hope that helps.

    我們的美國市場佔有率較低。大約是9%。因此,通常情況下,我們的國家能夠強調更直接的比較,但由於我強調的起始劑量,我們無法做到這一點。我們發現,我們大多數的國際附屬公司的市佔率都在十幾歲左右,有些甚至在二十多歲左右。因此,能夠進行與美國標籤直接相關的比較研究,並向醫生展示如何達到更高水準的控制。事實上,患者希望——他們不希望自己的皮膚出現任何疾病,如果他們能到達那裡,他們真的不希望發癢。這就是我們在《LEVEL UP》中所研究的內容。因此,我們認為這肯定有助於市場擴張,特別是在全球範圍內,我們有能力獲得更多份額。所以我希望這會有所幫助。

  • Operator

    Operator

  • Our next question comes from Tim Anderson with Wolfe Research.

    我們的下一個問題來自沃爾夫研究公司的蒂姆·安德森。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • I have questions on contracting for Skyrizi in '25. How many lives do you already have locked up through your general multiyear contracting? And then do you continue to think that the availability of cheap versions of Humira, either brand or biosimilar, won't lead to any increase in step edits on Skyrizi? Under the idea that while Skyrizi is better, something like Humira or biosimilar Stelara might be just fine. That same argument can be made in the statin category, for example, Crestor is the best, Zocor might do just fine.

    我對 25 年 Skyrizi 合約有疑問。您已經透過多年期合約鎖定了多少人的生命?然後,您是否仍然認為廉價版 Humira(無論是品牌藥還是生物仿製藥)的可用性不會導致 Skyrizi 的步驟編輯增加?儘管 Skyrizi 更好,但像 Humira 或生物相似藥 Stelara 這樣的藥物可能也不錯。同樣的論點也適用於他汀類藥物,例如,Crestor 是最好的,而 Zocor 可能也不錯。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. I think we'll probably pass on the number of lives locked up. I mean we are confident, given the market position TAM of Skyrizi and Rinvoq, I think, in particular around the momentum that we have across the Skyrizi indication that we're going to have very favorable access in 2025 and beyond. I think the other thing that we've highlighted is I'm very pleased with how the adoption of Skyrizi is going in IBD. I mean it's very, very clear that we're taking significant share from Stelara, and the doctors are voting with their pen or they're basically electronic prescribing, because the ability to get these very sensitive patients under significant control, the world's really never seen anything like the SEQUENCE trial in terms of the ability to control the most difficult aspect of this challenging disease. So as time goes by, we think that differentiation is going to aid us significantly as we think about the formulary positions relative to not only Humira, but also to Stelara.

    是的。我想我們可能會傳遞被關的人數。我的意思是,考慮到 Skyrizi 和 Rinvoq 的 TAM 市場地位,我認為我們很有信心,特別是 Skyrizi 的勢頭表明我們將在 2025 年及以後獲得非常有利的准入機會。我認為我們強調的另一件事是我對 Skyrizi 在 IBD 中的採用感到非常滿意。我的意思是,很明顯,我們從Stelara 那裡獲得了很大的份額,醫生們正在用筆投票,或者他們基本上是電子處方,因為能夠讓這些非常敏感的患者受到嚴格控制,世界上真的從來沒有在控制這種具有挑戰性的疾病最困難的方面的能力方面,我們看到了類似 SEQUENCE 試驗的情況。因此,隨著時間的推移,我們認為,當我們考慮相對於 Humira 和 Stelara 的處方位置時,差異化將對我們有很大幫助。

  • Operator

    Operator

  • The 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 & Global Pharma Analyst

    Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team & Global Pharma Analyst

  • It's on Elahere. I wonder whether you might be able to tell us the full quarter of sales. And then any commentary around penetration rate of Elahere and how much off-label use you think may be happening with the guideline inclusion?

    這是在埃拉赫爾。我想知道您能否告訴我們整個季度的銷售額。然後,關於 Elahere 的滲透率以及您認為納入指南可能會發生多少超說明書使用的評論?

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Sure. Thanks, Luisa. It's Scott. With respect to the Elahere full quarter of sales, so we closed midyear in February. Prior to that, there were -- according to what we've seen approximately, just let me just double-check here, $70 million -- I'm sorry, $110 million in the full quarter, $113 million in the full quarter.

    當然。謝謝,路易莎。這是斯科特。就 Elahere 整個季度的銷售額而言,我們在二月年中關閉。在此之前,根據我們所看到的大約情況,請讓我在這裡仔細檢查一下,7000 萬美元,對不起,整個季度為 1.1 億美元,整個季度為 1.13 億美元。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • And it's Jeff. What we also see in the marketplace, a big catalyst that we saw in the first quarter was the movement from the accelerated approval to the full approval that Roopal highlighted with the MIRASOL data. So we were rapidly able to basically integrate that into all the material, of the medical liaisons and certainly, the account managers and sales folks. And having that definitive table in the label and the ability to go deeper into our call plan is going to be very positive to continue the growth rates through the rest of the year.

    這是傑夫。我們在市場上也看到,我們在第一季看到的一個重要催化劑是 Roopal 在 MIRASOL 數據中強調的從加速批准到全面批准的轉變。因此,我們很快就能將其基本上整合到所有資料中,包括醫療聯絡人員,當然還有客戶經理和銷售人員。在標籤中擁有這個明確的表格以及更深入地了解我們的通話計劃的能力對於在今年剩餘時間裡繼續保持增長率將是非常積極的。

  • In terms of off-label, that's difficult to say. We think that the majority of the sales thus far are in that platinum-resistant population. However, the guidelines do allow for reimbursement with different levels of FRA alpha, some of the updates that I mentioned in my prepared remarks. So we'll continue to monitor it, but there's certainly significant headroom in terms of the populations that are coming in terms of the ovarian cancer marketplace.

    就標籤外而言,這很難說。我們認為迄今為止大部分銷量都來自對鉑金有抵抗力的人群。然而,該指南確實允許以不同級別的 FRA alpha 進行報銷,這是我在準備好的發言中提到的一些更新。因此,我們將繼續對其進行監測,但就卵巢癌市場的人口而言,肯定還有很大的發展空間。

  • 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

  • When looking at the strong performance of the neuro franchise of Vraylar and migraine in particular, talk about the competitive dynamics there in those markets. And how did the gross to net impact you in 1Q versus what you expected? And how should that trend for the rest of the year? And then with respect to Cerevel, just your confidence that it will still close by midyear, and how FTC is viewing the schizophrenia market and how much overlap there might be between emraclidine and Vraylar? Just the latest thinking on that based on your conversations with FTC.

    當看到 Vraylar 的神經特許經營權特別是偏頭痛的強勁表現時,請談談這些市場的競爭動態。與您的預期相比,第一季的總淨值對您有何影響?今年剩餘時間這種趨勢該如何?然後,關於 Cerevel,您是否相信它仍將在年中關閉,FTC 如何看待精神分裂症市場以及 emraclidine 和 Vraylar 之間可能有多少重疊?這是根據您與 FTC 的對話得出的最新想法。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. It's Jeff. I'll take the competitiveness comment in terms of what we're looking at. We're very pleased with the competitive -- our ability to gain market share in these segments. I'll start off with migraine. We continue to be the new-to-brand share leader in Botox for chronic migraine, and we see that Qulipta is accelerating significantly. So Qulipta is now the leading preventative agent. And what's nice is there's very little interaction with Botox because if you're an injector, you use Botox; if you're not an injector, you have access to a fantastic drug with Qulipta. So Qulipta is really clearly taking over the market leadership position among the injectable and the oral CGRPs.

    是的。是傑夫。我將根據我們正在關注的內容來看待競爭力評論。我們對我們在這些領域獲得市場份額的競爭力感到非常滿意。我將從偏頭痛開始。我們繼續成為治療慢性偏頭痛的 Botox 的新品牌份額領導者,我們看到 Qulipta 的發展速度顯著加快。因此,Qulipta 現在是領先的預防劑。好的一點是,與 Botox 的相互作用非常少,因為如果你是注射者,你就使用 Botox;如果你是注射者,你就使用 Botox。如果您不是注射者,您可以透過 Qulipta 獲得一種神奇的藥物。因此,Qulipta 確實明顯佔據了注射劑和口服 CGRP 領域的市場領導地位。

  • Ubrelvy continues to have a very meaningful and substantial lead over the main competitor, Nurtec, and we are seeing some increased penetration into the larger triptan segment, which is key to our long-term growth. Vraylar continues to perform very well, ongoing market growth. And it's really because we have -- if we look at our perceptions, Gary, of our key prescribers, you're at the very, very top of the table, the league table in terms of perceptions around the efficacy around adjunctive major depression, which is our most recent indication. And we have probably the best scope of indications for bipolar I. And so both of those are allowing us to continue to gain share. So we're in a pretty good position. We also feel that the gross to net, our vouchers, our co-pay, which sometimes can get a little funky in the first quarter, we have strong controls there and we're seeing a lot of stability. So overall, those businesses are performing very well.

    Ubrelvy 相對於主要競爭對手 Nurtec 繼續保持著非常有意義和實質的領先優勢,我們看到更大的曲普坦細分市場的滲透率有所增加,這是我們長期成長的關鍵。 Vraylar 繼續表現出色,市場持續成長。這確實是因為我們——加里,如果我們看看我們對主要處方醫生的看法,你就處於非常非常靠前的位置,就輔助性重度抑鬱症療效的看法而言,您處於排行榜的首位,這是我們最新的跡象。我們可能擁有 I 型雙相情感障礙的最佳適應症範圍。所以我們處於一個非常好的位置。我們還認為,毛淨額、我們的代金券、我們的自付額,有時在第一季可能會變得有點奇怪,我們在那裡有強有力的控制,並且我們看到了很大的穩定性。總的來說,這些企業的表現都非常好。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Gary, I'll take your question. This is Rob. I'll take your question on the FTC. We are working closely with the agency on their additional requests. I mean keep in mind that we do not have any overlapping MOAs with Cerevel, and Vraylar's share in schizophrenia is very low. The vast majority of Vraylar sales comes from the bipolar and AMDD indications. In the case of Tavapadon, it will serve the early Parkinson's segment, which Duodopa and VYALEV do not participate in. So we don't have any concerns with the merits of the transaction and continue to expect closing it in the middle of the year.

    加里,我來回答你的問題。這是羅布。我將向聯邦貿易委員會回答你的問題。我們正在與該機構密切合作,滿足他們的額外要求。我的意思是請記住,我們與 Cerevel 沒有任何重疊的 MOA,而且 Vraylar 患有精神分裂症的比例非常低。 Vraylar 的絕大多數銷售來自躁鬱症和 AMDD 適應症。就 Tavapadon 而言,它將服務於早期帕金森氏症細分市場,而 Duodopa 和 VYALEV 不參與其中。

  • Operator

    Operator

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

    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

  • And I apologize in advance for asking you to clarify on Humira. But you mentioned several times that things are playing out as planned. But in the prepared remarks, you said U.S. erosion played out slightly better than you thought in Q1. So is the conclusion that whatever was better is temporary? You also mentioned volume pressure, but price -- offset by price benefit. Can you quantify that? But when you sum it all up, it sounds like you expect volumes to underperform the expectations you set 3 months ago. And is that in part maybe due to the Accredo news from yesterday? So that's a big -- that's a long question, but that's only one question. And the second question is curious if the FDA has contacted AbbVie about the potential safety issues with emraclidine post the competitor issue with convulsions in rabbits. And have you seen this with your agent?

    對於要求您澄清 Humira 的問題,我提前表示歉意。但你多次提到事情正在按計劃進行。但在準備好的演講中,您表示美國第一季的侵蝕情況比您想像的要好一些。那麼,更好的結論是否只是暫時的呢?您還提到了數量壓力,但價格壓力被價格優勢所抵消。你能量化一下嗎?但當你總結這一切時,聽起來你預計成交量將低於你 3 個月前設定的預期。這是否部分是由於昨天 Accredo 的新聞?所以這是一個很大的問題——這是一個很長的問題,但這只是一個問題。第二個問題是,在競爭對手引起兔子抽搐的問題之後,FDA 是否已聯繫艾伯維(AbbVie)了解恩拉克定的潛在安全問題。你和你的經紀人看過這個嗎?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. So it's Jeff. So I'll try to take that. So the first part was the first quarter. I mean it was marginally better in terms of overall performance because we didn't see -- obviously, we didn't see any volume disruption until 4/1. Now when you look at 4/1 and we look -- after 3 weeks, we look at our model in terms of the expectation around retention of Humira with the CVS template, that's largely tracking in line with what our expectations were with a bit of the surprise that some of that Humira is not going to the biosimilar. As I mentioned, it's going to other mechanisms, including Skyrizi and Rinvoq.

    是的。所以是傑夫。所以我會嘗試接受這一點。所以第一部分是第一季。我的意思是,就整體性能而言,它稍微好一些,因為我們沒有看到——顯然,直到 4 月 1 日我們才看到任何數量中斷。現在,當您查看4/1 時,我們會看到- 3 週後,我們根據對使用CVS 模板的Humira 保留的預期來查看我們的模型,這在很大程度上與我們的預期一致,但有一點令人驚訝的是,其中一些 Humira 不會用於生物相似藥。正如我所提到的,它將轉向其他機制,包括 Skyrizi 和 Rinvoq。

  • So overall, as we look to the balance of the -- really the first quarter, what we're seeing play out in the second quarter and look to the full year, our commentary, and I'll ask Rob to highlight if he has anything to add, is very much in line with what we've guided at the beginning of the year. So no material change in what we're seeing in the marketplace.

    總的來說,當我們關注第一季的平衡時,我們看到第二季度的情況以及全年的情況,我們的評論,我會請羅布強調他是否有需要補充的內容與我們年初的指導非常一致。因此,我們在市場上看到的情況沒有實質變化。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Yes. This is Rob. I'll confirm that, what Jeff is saying. I mean it's tracking in line with our expectations. We are not saying that volume is worse than we originally guided. We're saying this is tracking in line with our expectations. We try to characterize for you the price versus volume dynamics. [As I was saying], it's the price erosion is the vast majority of the decline, but there is volume, and it's tracking exactly as we anticipated. So there isn't an additional downside here. And as Jeff mentioned, we did have slightly better performance in the first quarter. But again, it was -- I mean, I think, to the tune of $30 million to $40 million on this book of business, not overly material, but ahead of the initial expectation.

    是的。這是羅布。我會證實傑夫所說的。我的意思是它的追蹤符合我們的預期。我們並不是說成交量比我們最初指導的還要差。我們說這符合我們的預期。我們試著為您描述價格與成交量動態的關係。 [正如我所說的],價格下跌佔了跌幅的絕大部分,但成交量是存在的,而且它的走勢完全符合我們的預期。所以這裡沒有額外的缺點。正如傑夫所提到的,我們第一季的表現確實稍微好一點。但同樣,我的意思是,我認為,這本商業手冊的金額約為 3000 萬至 4000 萬美元,不太重要,但超出了最初的預期。

  • Roopal Thakkar - Senior VP & Chief Medical Officer of Global Therapeutics

    Roopal Thakkar - Senior VP & Chief Medical Officer of Global Therapeutics

  • Steve, it's Roopal. I can take the next question. We did a thorough diligence. And when we look at data sets that offer clinical data, obviously, we do a deep dive there, also look at blinded data. But we also do a deep dive looking at toxicology, animal tox, in particular. And we didn't observe anything that was consistent with what has been described thus far. And as I mentioned, when we look at blinded safety data either from the Ib or the current pivotals that are running, we don't see an adverse event like this that would be related. And as far as we know, no health authority has reached out to ask any further questions about this.

    史蒂夫,我是魯帕爾。我可以回答下一個問題。我們進行了徹底的調查。當我們查看提供臨床數據的數據集時,顯然,我們會進行深入研究,也會查看盲數據。但我們也深入研究毒理學,特別是動物毒素。我們沒有觀察到任何與迄今為止所描述的內容一致的情況。正如我所提到的,當我們查看來自 Ib 或當前正在運行的關鍵點的盲態安全資料時,我們沒有看到類似這樣相關的不良事件。據我們所知,目前還沒有衛生當局就此詢問任何進一步的問題。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Steve, this is Rob. I'm going to come back to your previous question, and maybe I understand where the confusion could be. That onetime price benefit is a year-over-year dynamic. It was contemplated in our guidance. When you have a formulary change, you essentially have those rebates go away and you recognize that. That was part of our guidance. That was not a benefit versus our guidance, that's a benefit in the year-over-year. So if you look at Scott guided to, I think it was 32%.

    史蒂夫,這是羅布。我將回到你之前的問題,也許我明白困惑可能在哪裡。這種一次性的價格優勢是逐年變動的。我們的指導中已經考慮到了這一點。當你的處方改變時,你基本上就會取消這些回扣,並且你意識到這一點。這是我們指導的一部分。這並不是相對於我們的指導的好處,而是逐年的好處。所以如果你看看 Scott 的指導,我認為是 32%。

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • That's right.

    這是正確的。

  • Robert A. Michael - President & COO

    Robert A. Michael - President & COO

  • Erosion in the second quarter, which is lower than -- it was around 40% in the first quarter. So naturally, you'd wonder why would you have less erosion. Well, there's that year-over-year dynamic, but that was how we planned the year. We anticipated it because we knew about the change that was coming in April 1. So I don't want you to interpret that as a benefit versus our guidance, that's a benefit in the year-over-year calculation.

    第二季的侵蝕程度低於第一季的 40% 左右。因此,您自然會想知道為什麼侵蝕會減少。嗯,年復一年的動態是存在的,但這就是我們今年的計畫。我們預料到了這一點,因為我們知道 4 月 1 日即將發生的變化。 所以我不希望您將其解釋為相對於我們指導的收益,這是同比計算中的收益。

  • Operator

    Operator

  • The next question comes from Trung Huynh with UBS.

    下一個問題來自瑞銀集團的 Trung Huynh。

  • Trung Chuong Huynh - Analyst

    Trung Chuong Huynh - Analyst

  • Trung Huynh from UBS. Congratulations, Rick, on the next chapter of your life and role to moving AbbVie forward. Again, on biosimilar Humira. In your remarks, you mentioned post the expected CVS contract, there was a step-up in price for Humira. Is that simply because you're giving away more price to CVS at the contract at the time? And you mentioned additional contracts moving to biosimilar like CVS this year. Are there any meaningful contracts here that you can flag so we're not surprised? And is it possible we could see actually a pricing increase by year-end because of this?

    瑞銀 (UBS) 的 Trung Huynh。恭喜 Rick,您開啟了人生的新篇章,並在推動艾伯維 (AbbVie) 向前發展方面發揮了重要作用。再次,關於生物仿製藥 Humira。在您的演講中,您提到在預期的 CVS 合約簽訂後,Humira 的價格有所上漲。這僅僅是因為您當時在合約中向 CVS 提供了更多價格嗎?您提到今年有更多合約轉向 CVS 等生物相似藥。這裡是否有任何有意義的合約可供您標記,以便我們不會感到驚訝?我們是否有可能因此在年底看到價格上漲?

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Trung, this is Scott. I'll start with your question regarding the price benefit. So in my remarks, I indicated that with the formulary change in CVS and the volume step-down we saw there, that there's a onetime price benefit associated with that. And you can think of this as, as we have the volume declines, that volume had been associated with price that we would have been paying in terms of rebate, that those rebates will no longer be paid. Therefore, there's a onetime price benefit associated with that initial step-down in the quarter. So that's what that relates to.

    特朗,這是史考特。我將從你關於價格優勢的問題開始。因此,在我的演講中,我指出,隨著 CVS 的配方變化以及我們看到的交易量下降,存在與此相關的一次性價格優勢。您可以將其視為,當我們的銷售量下降時,該銷售與我們本應以回扣形式支付的價格相關聯,這些回扣將不再支付。因此,本季最初的降價帶來了一次性的價格優勢。這就是相關的內容。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. And in terms of what we see going forward, as I highlighted, we don't see a significant exclusionary action where Humira would be removed from a formulary going forward. We did plan for, obviously, that smaller plans may make some adjustments to their formularies. That's all within the volume degradation and the pricing dynamics that we put into our guidance. And as I mentioned in one of the comments, some of the payers, not super large, would maybe consider this idea of starting new patients on the biosimilars versus maintaining all the existing patients on Humira. So if you were to see that, you shouldn't be surprised about that. And that would be within the contemplated approaches that we're taking as we look across '24 with our knowledge of what's happening in the marketplace.

    是的。就我們未來的情況而言,正如我所強調的,我們沒有看到任何重大的排他性行動,將修美樂從未來的處方集中刪除。顯然,我們確實計劃較小的計劃可能對其處方集進行一些調整。這一切都在我們納入指引的銷售下降和定價動態範圍內。正如我在其中一條評論中提到的,一些付款人(規模不是很大)可能會考慮讓新患者使用生物相似藥,而不是讓所有現有患者繼續使用 Humira。因此,如果您看到這一點,您不應該感到驚訝。當我們根據市場上正在發生的事情來展望 24 世紀時,這將屬於我們正在採取的預期方法。

  • Operator

    Operator

  • And our final question comes from Evan Seigerman with BMO Capital Markets.

    我們的最後一個問題來自 BMO 資本市場的 Evan Seigerman。

  • Evan David Seigerman - MD & Senior BioPharma Research Analyst

    Evan David Seigerman - MD & Senior BioPharma Research Analyst

  • On the aesthetics business, maybe talk to me about some of the dynamics you're seeing in China. I know that there's a lot of macro headwinds, and this is a pretty big part of your business. And then a bit of housekeeping on Skyrizi. Last quarter, you disclosed the $1.9 billion cash payment for royalties. Can you provide us any color on what this quarter's royalty was? And I believe that was for the full year last year, but maybe just for this quarter.

    關於美學業務,也許可以和我談談你在中國看到的一些動態。我知道存在著許多宏觀阻力,而這是您業務的一個相當大的部分。然後是 Skyrizi 上的一些內務管理工作。上季度,您揭露了 19 億美元的特許權使用費現金支付情況。您能否向我們提供有關本季特許權使用費的任何資訊?我相信這是去年全年的情況,但也許只是本季的情況。

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

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

  • This is Carrie. I'll address your question on aesthetics in China. And we do expect economic headwinds that we're seeing in China to persist over the near term with the China aesthetics market flat overall for 2024. So the way to think about it is to expect negative market until the recovery starts to begin in the second half of 2024. China does remain a very important market for our aesthetics business. And as the market there starts to recover, we will continue to invest in consumer activation, injector training and continue to launch new products in this important market.

    這是嘉莉。我來回答你關於中國美學的問題。我們確實預計,中國的經濟逆風將在短期內持續存在,而 2024 年中國美容市場總體持平。 。隨著那裡的市場開始復甦,我們將繼續投資於消費者活化、注射器培訓,並繼續在這個重要市場推出新產品。

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • It's Scott. So you're right. With respect to the Skyrizi royalty payments, so you have to remember that these are on a bit of a lag, so they don't track each quarter sales. But the $400 million was the amount in the first quarter that we paid in cash payment.

    這是斯科特。所以你是對的。關於 Skyrizi 特許權使用費,您必須記住,這些費用有點滯後,因此他們不會追蹤每個季度的銷售額。但這4億美元是我們第一季以現金支付的金額。

  • Elizabeth Shea - SVP of IR

    Elizabeth Shea - SVP of IR

  • Well, thanks, Evan. 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.

    嗯,謝謝,埃文。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. That concludes today's conference. You may all disconnect at this time.

    謝謝。今天的會議到此結束。此時你們都可以斷開連線。