艾伯維 (ABBV) 2023 Q1 法說會逐字稿

內容摘要

艾伯維(AbbVie)報告了 2023 年第一季度的強勁業績,其所有五個關鍵治療領域均達到或超過預期。公司的增長是由主要產品(包括 Skyrizi 、 Rinvoq 、 Venclexta 和 Vraylar )兩位數的銷售增長推動的。

艾伯維(AbbVie)的美容業務也表現出積極的勢頭,在國際上取得了強勁的成績,並穩定了美國的消費趨勢。該公司已將其全年調整後每股收益指引上調了 0.10 美元。

艾伯維(AbbVie)很好地應對了 Humira 的生物仿製藥侵蝕,並看到了其多元化產品組合推動長期增長的眾多機會。該公司正在探索不同的資產和機制,以找到能夠帶來強勁業績的資產和機制。

AbbVie 認為,從 FTC 的角度來看,它可以自由地在擁擠的免疫學市場的大部分領域開展業務。

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 2023 Earnings Conference Call. (Operator Instructions)

    早上好,謝謝你的支持。歡迎來到 AbbVie 2023 年第一季度收益電話會議。 (操作員說明)

  • I would now like to introduce Ms. Liz Shea, Senior Vice President, Investor Relations.

    我現在想介紹投資者關係高級副總裁 Liz Shea 女士。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP 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, Vice Chairman and President; Jeff Stewart, Executive Vice President and Chief Commercial Officer; Scott Reents, Executive Vice President and Chief Financial Officer; Carrie Strom, Senior Vice President and President, Allergan aesthetics; and Tom Hudson, Senior Vice President, R&D and Chief Scientific Officer. Joining us for the Q&A portion of the call is Roopal Thakkar, Senior Vice President, Development and Regulatory Affairs and Chief Medical Officer.

    早上好,感謝您加入我們。今天與我通話的還有董事會主席兼首席執行官里克·岡薩雷斯 (Rick Gonzalez); Rob Michael,副董事長兼總裁;執行副總裁兼首席商務官 Jeff Stewart; Scott Reents,執行副總裁兼首席財務官; Carrie Strom,艾爾建美學部高級副總裁兼總裁;以及研發高級副總裁兼首席科學官 Tom Hudson。與我們一起參加電話問答部分的是開發和監管事務高級副總裁兼首席醫療官 Roopal Thakkar。

  • 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,我會指出,我們今天所做的一些聲明可能被視為基於我們當前預期的前瞻性聲明。艾伯維警告說,這些前瞻性陳述受風險和不確定因素的影響,可能導致實際結果與我們的前瞻性陳述中所示的結果存在重大差異。我們向美國證券交易委員會提交的文件中包含有關這些風險和不確定性的更多信息。除法律要求外,艾伯維不承擔更新這些前瞻性陳述的義務。

  • On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions.

    在今天的電話會議上,將使用非 GAAP 財務指標來幫助投資者了解 AbbVie 的經營業績。這些非 GAAP 財務措施與我們今天發布的收益報告和監管文件中的可比 GAAP 財務措施相一致,這些措施可以在我們的網站上找到。在我們準備好的評論之後,我們將回答您的問題。

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

    因此,我將把電話轉給里克。

  • 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 2023. With first quarter total revenues and adjusted earnings per share both exceeding our expectations. This performance was driven by double-digit sales growth from several key products, including Skyrizi, Rinvoq, Venclexta and Vraylar. Positive momentum from our aesthetics business with strong results internationally and stabilizing consumer trends in the U.S. and in line performance from U.S. Humira where biosimilar erosion is tracking as expected with much of the impact driven by price.

    謝謝你,麗茲。大家早上好,感謝您今天加入我們。我對我們 2023 年的開局感到非常高興。第一季度的總收入和調整後的每股收益都超出了我們的預期。這一業績是由包括 Skyrizi 、 Rinvoq 、 Venclexta 和 Vraylar 在內的幾個關鍵產品的兩位數銷售增長推動的。我們的美容業務的積極勢頭在國際上取得了強勁的成果,並在美國穩定了消費者趨勢,在美國 Humira 的表現也符合預期,其中生物仿製藥的侵蝕正如預期的那樣受到價格驅動的影響。

  • Since our inception, we have successfully created a well-diversified portfolio with multiple growth platforms in highly attractive markets, including immunology, hematological oncology, neuroscience and aesthetics. Our commercial execution, including the launch of new products and expanded indications has been outstanding, especially across Skyrizi and Rinvoq and recently with Vraylar and MDD. Each of these assets are expected to contribute significant revenue growth over the decade. The breadth and the depth of our R&D pipeline also supports our long-term growth outlook and we anticipate numerous important pipeline milestones over the next 2 years.

    自成立以來,我們已在極具吸引力的市場(包括免疫學、血液腫瘤學、神經科學和美學)中成功創建了具有多個增長平台的多元化產品組合。我們的商業執行,包括新產品的發布和擴展適應症,一直非常出色,尤其是在 Skyrizi 和 Rinvoq 以及最近與 Vraylar 和 MDD 的合作中。預計這些資產中的每一項都將在未來十年內貢獻顯著的收入增長。我們研發管道的廣度和深度也支持我們的長期增長前景,我們預計未來 2 年將有許多重要的管道里程碑。

  • In summary, we are 1 quarter into the U.S. biosimilar event for Humira and are managing the erosion well. Most importantly, our growth platform is demonstrating strong performance, exceeding our expectations. We are executing well across all aspects of our business and see numerous opportunities for our diverse portfolio to drive long-term growth.

    總而言之,我們進入美國 Humira 生物仿製藥事件的第一個季度,並且正在很好地控制侵蝕。最重要的是,我們的增長平台表現強勁,超出了我們的預期。我們在業務的各個方面都表現良好,並看到我們多樣化的投資組合有許多機會來推動長期增長。

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

    有了這個,我會把電話轉給羅布,讓他對我們的業務績效發表更多評論。搶?

  • Robert A. Michael - Vice Chairman & President

    Robert A. Michael - Vice Chairman & President

  • Thank you, Rick. We're off to an excellent start in 2023 with each of our 5 key therapeutic areas meeting or exceeding our first quarter expectations, a testament to the strength of our broad portfolio. We delivered adjusted earnings per share of $2.46, which is $0.10 above our guidance midpoint. Total net revenues were $12.2 billion, approximately $400 million ahead of our expectations.

    謝謝你,里克。我們在 2023 年有了一個良好的開端,我們的 5 個關鍵治療領域中的每一個都達到或超過了我們第一季度的預期,這證明了我們廣泛的產品組合的實力。我們公佈的調整後每股收益為 2.46 美元,比我們的指導中點高出 0.10 美元。總淨收入為 122 億美元,比我們的預期高出約 4 億美元。

  • First quarter results include continued robust performance from Skyrizi and Rinvoq, which remain on track to contribute more than $11 billion in combined sales this year. Growth rates in the first quarter for both products are consistent with our full year expectations.

    第一季度的業績包括 Skyrizi 和 Rinvoq 的持續強勁表現,這兩家公司今年的合併銷售額有望貢獻超過 110 億美元。兩種產品第一季度的增長率都符合我們的全年預期。

  • Skyrizi and Rinvoq are demonstrating momentum across all approved indications and we expect to round out their opportunities in IBD later this year. This includes Rinvoq's anticipated U.S. approval in Crohn's disease as well as Skyrizi's European launch in Crohn's and its global regulatory submission in UC.

    Skyrizi 和 Rinvoq 在所有批准的適應症上都顯示出勢頭,我們預計將在今年晚些時候完成他們在 IBD 方面的機會。這包括 Rinvoq 在克羅恩病方面預期在美國獲得批准,以及 Skyrizi 在克羅恩病中的歐洲上市及其在 UC 的全球監管提交。

  • We are also performing exceptionally well in neuroscience. Total net revenues this quarter were nearly $200 million above our guidance with Vraylar sales accelerating following MDD approval and migraine delivering strong growth. As a result, we will be increasing our full year outlook for neuroscience.

    我們在神經科學方面也表現出色。本季度的總淨收入比我們的指導高出近 2 億美元,Vraylar 的銷售在 MDD 批准後加速增長,偏頭痛帶來強勁增長。因此,我們將提高對神經科學的全年展望。

  • Aesthetics is also performing better than expected. We are seeing positive recovery trends in China and some stability in the U.S. market, where we are closely monitoring several economic indicators that correlate with aesthetics procedures, including consumer confidence, personal consumption and Google searches. Although it's still early in the year, these positive trends, especially across our international markets, give us the confidence to increase our full year outlook for aesthetics as well. This continues to be an underpenetrated market with significant growth potential.

    美學方面的表現也好於預期。我們看到中國的積極復甦趨勢和美國市場的一些穩定,我們正在密切關注與美容程序相關的幾個經濟指標,包括消費者信心、個人消費和谷歌搜索。雖然現在還處於年初,但這些積極的趨勢,尤其是在我們的國際市場上,讓我們有信心增加全年的美學前景。這仍然是一個未充分滲透的市場,具有巨大的增長潛力。

  • Based on our robust performance this quarter and the continued strong outlook for our business, we are raising our full year adjusted earnings per share guidance by $0.10 and now expect adjusted earnings per share between $10.72 and $11.12.

    基於我們本季度的強勁表現和我們業務持續強勁的前景,我們將全年調整後每股收益指引上調 0.10 美元,現在預計調整後每股收益在 10.72 美元至 11.12 美元之間。

  • In closing, I'm extremely pleased with the performance of our diverse portfolio. We're off to a strong start to the year, which further reinforces our confidence in the long-term outlook of the business.

    最後,我對我們多元化投資組合的表現感到非常滿意。我們今年開局強勁,這進一步增強了我們對業務長期前景的信心。

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

    有了這個,我會把電話轉給傑夫,讓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'm very pleased with the strong commercial execution across our therapeutic portfolio. Immunology delivered total revenues of approximately $5.6 billion with continued robust double-digit growth from Skyrizi and Rinvoq. Skyrizi global sales were nearly $1.4 billion, reflecting operational growth of more than 46%, despite retail inventory destocking in the quarter. Skyrizi is the clear market leader in the U.S. biologic psoriasis market with a total prescription share now at 30%.

    謝謝你,羅布。我對我們治療產品組合的強大商業執行感到非常滿意。隨著 Skyrizi 和 Rinvoq 持續強勁的兩位數增長,Immunology 的總收入約為 56 億美元。儘管本季度零售庫存減少,但 Skyrizi 的全球銷售額接近 14 億美元,營業增長率超過 46%。 Skyrizi 是美國生物銀屑病市場明顯的市場領導者,目前處方藥的總份額為 30%。

  • In psoriasis, Skyrizi has set a very high bar relative to other therapies on the market or in development with differentiated attributes across the categories that physicians and patients deem most important. This includes the rapid onset of action after the first dose, nearly complete skin clearance with multifold higher rates on PASI 90 and PASI 100. High durability of response, which we have demonstrated can increase over time as well as quarterly dosing for maintenance therapy, a convenient alternative to daily oral or more frequently administered injectables. With a nearly 50% U.S. in-play share of new and switching patients, there is substantial room for Skyrizi's continued growth in psoriasis.

    在銀屑病方面,Skyrizi 相對於市場上或正在開發的其他療法設定了非常高的標準,在醫生和患者認為最重要的類別中具有差異化屬性。這包括首次給藥後起效迅速,幾乎完全清除皮膚,PASI 90 和 PASI 100 的清除率高出數倍。反應的持久性高,我們已經證明可以隨著時間的推移以及維持治療的季度給藥而增加,a每日口服或更頻繁注射的方便替代品。憑藉美國近 50% 的新患者和轉換患者的在場份額,Skyrizi 在牛皮癬方面的持續增長空間很大。

  • This best-in-class profile is supporting strong momentum now in psoriatic arthritis with Skyrizi achieving an in-play biologic share of roughly 20% in the U.S. dermatology segment. Skyrizi is also being co-positioned with Rinvoq in the U.S. room segment in PSA where we are seeing increasing utilization among rheumatologists as well. Globally, Skyrizi has achieved in-play psoriatic disease leadership in more than 25 countries and total market share leadership in nearly 20 of those key markets.

    這一一流的概況正在支持目前在銀屑病關節炎領域的強勁勢頭,Skyrizi 在美國皮膚病學領域的生物製劑份額達到約 20%。 Skyrizi 還與 Rinvoq 在 PSA 的美國房間部分共同定位,我們也看到風濕病學家的利用率也在增加。在全球範圍內,Skyrizi 在超過 25 個國家/地區的銀屑病治療領域處於領先地位,並在其中近 20 個主要市場的總市場份額處於領先地位。

  • In Crohn's disease, we are seeing very fast adoption of Skyrizi in the U.S., with a total in-play patient share at approximately 20%, second only to STELARA. Feedback from gastroenterologists is very positive, especially as it relates to Skyrizi's novel dosing and overall clinical profile. We see strong uptake in Japan and Canada as well with the European launch forthcoming.

    在克羅恩病方面,我們看到 Skyrizi 在美國的採用非常快,在場患者的總份額約為 20%,僅次於 STELARA。來自胃腸病學家的反饋非常積極,特別是因為它與 Skyrizi 的新穎劑量和整體臨床概況有關。隨著即將在歐洲推出,我們看到日本和加拿大的強勁增長。

  • We also recently reported strong induction data for Skyrizi in ulcerative colitis, which Tom will discuss momentarily. Based on the results of that trial, it is increasingly clear that Skyrizi represents a differentiated asset across inflammatory bowel disease and we look forward to bringing this potential new indication to physicians and patients next year.

    我們最近還報告了 Skyrizi 在潰瘍性結腸炎中的強大誘導數據,湯姆將立即討論。根據該試驗的結果,越來越清楚的是,Skyrizi 代表了炎症性腸病的差異化資產,我們期待明年將這一潛在的新適應症帶給醫生和患者。

  • Turning now to Rinvoq, which delivered global sales of $686 million, reflecting operational growth of more than 50% despite similar retail inventory destocking in the quarter. I'm very pleased with the performance in rheumatology with total prescriptions increasing across each of the 4 approved indications. Atopic dermatitis is also tracking in line with our expectations. We continue to see market share momentum globally, including in-play patient share increasing to approximately 17% in the U.S.

    現在轉向 Rinvoq,它實現了 6.86 億美元的全球銷售額,反映出儘管本季度類似的零售庫存去庫存,但運營增長超過 50%。我對風濕病學的表現感到非常滿意,4 個批准的適應症中的每一個都增加了總處方。特應性皮炎也符合我們的預期。我們繼續看到全球市場份額的增長勢頭,包括在美國的遊戲中患者份額增加到約 17%。

  • We are very excited about the growth potential in gastroenterology. Rinvoq has set a high bar for efficacy in both ulcerative colitis and Crohn's disease, demonstrating strong rates of remission and endoscopic improvement. We're seeing very strong momentum in UC, where adoption has been robust. Rinvoq is now achieving a 23% in-play share in the U.S. second-line plus setting, reflecting an impressive ramp since our launch in UC less than 1 year ago. This accelerated adoption among gastroenterologists is very encouraging for Rinvoq's pending outlook in Crohn's. We are currently launching this indication in the EU, a geography where Rinvoq is the only JAK approved to treat both IBD conditions, and we remain on track for CD approval and commercialization in the U.S. later this quarter with broad formulary access anticipated to ramp quickly over the back half of this year.

    我們對胃腸病學的增長潛力感到非常興奮。 Rinvoq 為潰瘍性結腸炎和克羅恩病的療效設定了很高的標準,顯示出很高的緩解率和內窺鏡改善率。我們看到 UC 的發展勢頭非常強勁,採用率一直很高。 Rinvoq 現在在美國二線及以上設置中取得了 23% 的在場份額,這反映出自我們在 UC 推出不到一年以來的驚人增長。這種在胃腸病學家中的加速採用對於 Rinvoq 在克羅恩病中的前景非常令人鼓舞。我們目前正在歐盟推出這一適應症,在該地區,Rinvoq 是唯一獲准治療兩種 IBD 病症的 JAK,我們仍有望在本季度晚些時候在美國獲得 CD 批准和商業化,預計廣泛的處方准入將迅速增加今年下半年。

  • So we see inflammatory bowel disease continues to be an area of high unmet need. Having 2 novel therapies in IBD with Skyrizi and Rinvoq that each deliver differentiated levels of efficacy is an important step forward for patients. And with these 2 complementary assets, we are very well positioned to compete against other oral or biological agents.

    因此,我們看到炎症性腸病仍然是一個高度未滿足需求的領域。 Skyrizi 和 Rinvoq 在 IBD 中擁有兩種新療法,每種療法都提供不同水平的療效,這對患者來說是向前邁出的重要一步。憑藉這兩項互補資產,我們非常有能力與其他口服或生物製劑競爭。

  • Global Humira sales were approximately $3.5 billion, down 24.3% on an operational basis due to biosimilar competition. Erosion in the U.S. remains in line with our expectations with most of the impact driven by price.

    由於生物仿製藥的競爭,修美樂的全球銷售額約為 35 億美元,在運營基礎上下降了 24.3%。美國的侵蝕仍然符合我們的預期,其中大部分影響是由價格驅動的。

  • Turning now to hematologic oncology, where total revenues were $1.4 billion with continued pressure on Imbruvica, partially offset by robust double-digit growth with Venclexta. Imbruvica global revenues were $878 million, down 25.2% due to increasing competition and the cumulative impact of a suppressed market. Venclexta global sales were $538 million, up 17.5% on an operational basis with strong momentum across both AML and CLL.

    現在轉向血液腫瘤學,總收入為 14 億美元, Imbruvica 的持續壓力,部分被 Venclexta 強勁的兩位數增長所抵消。 Imbruvica 全球收入為 8.78 億美元,下降 25.2%,原因是競爭加劇和市場受壓的累積影響。 Venclexta 的全球銷售額為 5.38 億美元,在運營基礎上增長了 17.5%,AML 和 CLL 的勢頭強勁。

  • In neuroscience, revenues were approximately $1.7 billion, up 15% on an operational basis. Vraylar is performing exceptionally well. Sales of $561 million were up 31.3% on an operational basis, above our expectations. We are very pleased with the AMDD label and the launch, which has resulted in a significant uplift in total new prescriptions for Vraylar. With a dedicated sales force that calls on both psychiatrists and primary care as well as ramping DTC promotion, we see an opportunity for accelerated growth across all approved indications. And we will be raising our full year guidance for Vraylar accordingly.

    在神經科學領域,收入約為 17 億美元,在運營基礎上增長了 15%。 Vraylar 表現異常出色。 5.61 億美元的銷售額在運營基礎上增長了 31.3%,超出了我們的預期。我們對 AMDD 標籤和發布感到非常滿意,這導致 Vraylar 的新處方總數顯著增加。憑藉一支敬業的銷售隊伍,呼籲精神科醫生和初級保健人員以及大力推廣 DTC,我們看到了在所有批准的適應症中加速增長的機會。我們將相應地提高對 Vraylar 的全年指導。

  • Within migraine, we remain uniquely positioned with a portfolio to support complete migraine freedom. Our leading oral CGRP therapies contributed $218 million in combined sales this quarter, reflecting growth of more than 45% as we continue to see strong prescription demand for both Ubrelvy and Qulipta. We recently expanded the label for Qulipta, which is now uniquely positioned as the only oral CGRP available as a preventative treatment for patients with both chronic and episodic migraine further strengthening our competitive profile.

    在偏頭痛領域,我們保持獨特的定位,擁有支持完全擺脫偏頭痛的產品組合。我們領先的口服 CGRP 療法本季度貢獻了 2.18 億美元的合併銷售額,反映了超過 45% 的增長,因為我們繼續看到對 Ubrelvy 和 Qulipta 的強勁處方需求。我們最近擴大了 Qulipta 的標籤,它現在被定位為唯一可作為慢性和發作性偏頭痛患者預防性治療的口服 CGRP,進一步加強了我們的競爭優勢。

  • Lastly, total Botox Therapeutic sales were $719 million, reflecting strong performance in chronic migraine as well as other approved indications. So overall, I'm extremely pleased with the performance across the therapeutic portfolio.

    最後,Botox Therapeutic 總銷售額為 7.19 億美元,反映出在慢性偏頭痛和其他獲批適應症方面的強勁表現。總的來說,我對整個治療組合的表現非常滿意。

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

    有了這個,我會把電話轉給嘉莉,徵求關於美學的更多評論。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 approximately $1.3 billion, which came in ahead of our guidance, primarily due to a faster reopening in China as well as a slightly stronger economy in the U.S. versus our planning assumption. In the U.S., aesthetics sales were $777 million, down 8.1% as we continue to see softness in aesthetics procedures related to inflationary dynamics. As a reminder, we saw a very robust performance for our U.S. performance in the first quarter of 2022, which created difficult comparison for growth in the first quarter of this year.

    謝謝你,傑夫。第一季度全球美容產品銷售額約為 13 億美元,超出了我們的預期,這主要是由於中國更快地重新開放以及美國經濟略高於我們的計劃假設。在美國,美容銷售額為 7.77 億美元,下降 8.1%,因為我們繼續看到與通貨膨脹動力學相關的美容程序疲軟。提醒一下,我們在 2022 年第一季度看到我們在美國的表現非常強勁,這與今年第一季度的增長形成了難以比較的局面。

  • U.S. Botox Cosmetic sales were $409 million, down slightly on a year-over-year basis. We continue to see a lesser impact from inflationary dynamics on Botox Cosmetic compared to other areas of our aesthetics portfolio due to its relatively lower price point and large install base of loyal repeat consumers.

    美國保妥適化妝品銷售額為 4.09 億美元,同比略有下降。與我們美學產品組合的其他領域相比,我們繼續看到通脹動態對 Botox Cosmetic 的影響較小,因為它的價格相對較低,而且忠實的回頭客的安裝基數很大。

  • The U.S. cosmetic toxin market was down low single digits in the first quarter on a year-over-year basis. Botox Cosmetic continues be the clear market leader and its share of the U.S. toxin market remains stable.

    美國化妝品毒素市場在第一季度同比下降了個位數。 Botox Cosmetic 仍然是明顯的市場領導者,其在美國毒素市場的份額保持穩定。

  • Sales for our U.S. Juvederm collection were down 18% as our dermal filler portfolio continues to be impacted by inflationary pressure on consumer spending. The U.S. filler market was down nearly 20% in the quarter on a year-over-year basis due to the persistent inflationary environment. Our Juvederm collection remains the clear market leader and share was stable in the quarter. The economic pressure on our U.S. dermal filler business is partially offset in the quarter by strong initial uptake for our recently launched Volux filler, which is approved for the improvement of jawline definition. We expect Volux combined with the upcoming launch of our skin quality injectable [Skinvive] to support long-term growth for our filler portfolio in the U.S.

    我們的美國 Juvederm 系列的銷售額下降了 18%,因為我們的真皮填充劑產品組合繼續受到消費者支出的通脹壓力的影響。由於持續的通貨膨脹環境,本季度美國填料市場同比下降近 20%。我們的 Juvederm 系列仍然是明顯的市場領導者,本季度的份額穩定。我們美國真皮填充劑業務的經濟壓力在本季度部分被我們最近推出的 Volux 填充劑的強勁初始吸收所抵消,該填充劑已獲准用於改善下巴輪廓。我們希望 Volux 與即將推出的皮膚質量注射劑 [Skinvive] 相結合,以支持我們的填充劑產品組合在美國的長期增長。

  • While the aesthetics category in the U.S. continues to be challenged due to the fast economy, the key external economic metrics that we track have remained relatively consistent with year-end 2022 levels.

    儘管美國的美學類別因經濟快速增長而繼續受到挑戰,但我們追踪的關鍵外部經濟指標與 2022 年底的水平保持相對一致。

  • Our international aesthetics portfolio continues to demonstrate robust growth with strong performance in Japan, which is rapidly growing and China, which is recovering faster than expected. Sales from our international aesthetics portfolio were $523 million, up 7.8% on an operational basis. International Botox Cosmetics sales grew approximately 17.5% operationally, and international Juvederm sales were down approximately 1.4% on an operational basis. China, which is our second largest market, was negatively impacted by COVID in January and February, but experienced a sharp recovery in March. We expect this level of activity to be sustained throughout the remainder of the year.

    我們的國際美容產品組合繼續表現強勁增長,在快速增長的日本和恢復速度快於預期的中國表現強勁。我們國際美容產品組合的銷售額為 5.23 億美元,在運營基礎上增長 7.8%。國際保妥適化妝品銷售額在運營方面增長了約 17.5%,而國際喬雅登銷售額在運營基礎上下降了約 1.4%。中國是我們的第二大市場,在 1 月和 2 月受到 COVID 的負面影響,但在 3 月經歷了急劇復甦。我們預計這一活動水平將在今年餘下時間持續。

  • Recall, our original guidance assumed we would not reach a full recovery until the second half of this year. And in Japan, which is an underdeveloped market and proving to be very responsive to promotion, we continue to make significant investments in injector training, our field force and consumer education. Overall, we are pleased with how our team has been executing through this dynamic environment and remain encouraged by improving trends internationally and stabilization across our U.S. portfolio. These positive trends and continued strong momentum give us the confidence to increase the full year outlook for our aesthetics business.

    回想一下,我們最初的指導假設我們要到今年下半年才能完全復甦。在日本,這是一個欠發達的市場,並且證明對促銷非常敏感,我們繼續在註射器培訓、現場工作人員和消費者教育方面進行大量投資。總的來說,我們對我們的團隊在這個充滿活力的環境中的表現感到滿意,並繼續受到國際趨勢的改善和我們美國投資組合的穩定性的鼓舞。這些積極的趨勢和持續強勁的勢頭使我們有信心提高我們美容業務的全年前景。

  • Longer term, we remain extremely confident in our ability to grow the aesthetics business and continue to expect to achieve total sales of more than $9 billion by the end of this decade. Aesthetics continues to be an extremely attractive underpenetrated market and our proven ability to drive consumer demand and develop a strong base of loyal customers as well as bring innovative new products to the market will support robust growth over the long term.

    從長遠來看,我們對我們發展美容業務的能力仍然充滿信心,並繼續期望到本十年末實現超過 90 億美元的總銷售額。美學仍然是一個極具吸引力的滲透率低的市場,我們在推動消費者需求、發展強大的忠誠客戶群以及將創新新產品推向市場方面的成熟能力將支持長期的強勁增長。

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

    有了這個,我會把電話轉給湯姆。

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

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

  • Thank you, Carrie. We've continued to make very good progress with our pipeline to start this year. In immunology, we recently received European approval for Rinvoq in Crohn's disease, making it the first JAK inhibitor approved for this indication. We continue to anticipate FDA approval for Rinvoq in Crohn's disease next month. We also recently announced positive top line results from our Phase III induction study for Skyrizi in ulcerative colitis, which is a disease with unpredictable symptoms and frequent players making it challenging to manage.

    謝謝你,嘉莉。從今年開始,我們的管道繼續取得很好的進展。在免疫學方面,我們最近獲得了歐洲對克羅恩病 Rinvoq 的批准,使其成為第一個獲批用於該適應症的 JAK 抑製劑。我們繼續期待下個月 FDA 批准 Rinvoq 治療克羅恩病。我們最近還宣布了我們針對 Skyrizi 治療潰瘍性結腸炎的 III 期誘導研究的積極頂線結果,這是一種症狀不可預測的疾病,頻繁的參與者使其難以管理。

  • In our study, Skyrizi met the primary and all secondary end points demonstrating a very strong impact on the disease as measured by clinical remission, clinical response and endoscopic improvement. We're particularly pleased with Skyrizi's impressive performance on the more stringent measures in this trial with approximately 37% of Skyrizi-treated patients achieving endoscopic improvement compared to 12% of patients on placebo. This level of efficacy has the potential to position Skyrizi as a highly effective therapy, and we believe it will be a welcome new treatment option for physicians and patients once approved. Detailed data from this induction study will be presented at a forthcoming medical meeting. We expect to see data from the Phase III maintenance study in the second quarter with our regulatory submissions planned for the second half of the year.

    在我們的研究中,Skyrizi 達到了主要終點和所有次要終點,表明通過臨床緩解、臨床反應和內窺鏡改善來衡量對疾病有非常強烈的影響。我們對 Skyrizi 在該試驗中更嚴格的措施方面令人印象深刻的表現感到特別滿意,大約 37% 接受 Skyrizi 治療的患者實現了內窺鏡改善,而接受安慰劑的患者只有 12%。這種療效水平有可能將 Skyrizi 定位為一種高效療法,我們相信一旦獲得批准,它將成為醫生和患者歡迎的新治療選擇。該入職研究的詳細數據將在即將召開的醫學會議上公佈。我們希望在第二季度看到來自 III 期維護研究的數據,我們計劃在下半年提交監管文件。

  • In oncology, we continue to make good progress across all stages of our hematology and solid tumor pipelines. We remain on track for several important regulatory and clinical milestones this year, including regulatory approval for epcoritamab in relapsed/refractory large B-cell lymphoma. Phase III data from Venclexta's CANOVA trial in relapsed/refractory in multiple myeloma patients with a t(1114) mutation and navitoclax's TRANSFORM-1 trial in frontline myelofibrosis. And Phase II data for Teliso-V in second line plus advanced non-squamous non-small cell lung cancer, which has the potential to support a regulatory submission for accelerated approval.

    在腫瘤學方面,我們在血液學和實體瘤管道的所有階段繼續取得良好進展。我們今年仍有望實現幾個重要的監管和臨床里程碑,包括監管部門批准 epcoritamab 治療復發/難治性大 B 細胞淋巴瘤。 III 期數據來自 Venclexta 的 CANOVA 試驗,該試驗用於治療具有 t(1114) 突變的多發性骨髓瘤患者的複發/難治性,以及 navitoclax 的 TRANSFORM-1 一線骨髓纖維化試驗。 Teliso-V 在二線加上晚期非鱗狀非小細胞肺癌的 II 期數據,有可能支持監管提交以加速批准。

  • We're also beginning to see very encouraging data for our next-generation c-Met ADC, which uses a more potent Topol payload than our Teliso-V ADC. Based on the data we've seen to date for ABBV-400 in our Phase I solid tumor basket study, we plan to expand the program to earlier lines in colorectal cancer as well as evaluate in other tumors where c-Met is expressed, including pancreatic and liver cancer.

    我們也開始看到我們下一代 c-Met ADC 的數據非常令人鼓舞,它使用比我們的 Teliso-V ADC 更有效的 Topol 有效載荷。根據我們迄今為止在 I 期實體瘤籃子研究中看到的 ABBV-400 數據,我們計劃將該計劃擴展到結直腸癌的早期細胞系,並在表達 c-Met 的其他腫瘤中進行評估,包括胰腺癌和肝癌。

  • Moving to our neuroscience pipeline, where we've recently received FDA approval for Qulipta as a preventive treatment for patients with chronic migraine, making it the only oral CGRP antagonist approved for prevention of both episodic and chronic migraine. In our Phase III study, Qulipta provided a significant reduction in migraine days as well as significant improvements in function and quality of life in patients with chronic migraine, a common and debilitating disease. As a highly effective oral treatment option, we believe Qulipta will be well positioned in a chronic migraine prevention market. In Europe, we continue to anticipate an approval decision in the third quarter for atogepant as a preventive treatment for patients with both chronic and episodic migraine.

    轉到我們的神經科學管道,我們最近獲得 FDA 批准 Qulipta 作為慢性偏頭痛患者的預防性治療,使其成為唯一被批准用於預防發作性和慢性偏頭痛的口服 CGRP 拮抗劑。在我們的 III 期研究中,Qulipta 顯著減少了偏頭痛天數,並顯著改善了慢性偏頭痛(一種常見的使人衰弱的疾病)患者的功能和生活質量。作為一種高效的口服治療選擇,我們相信 Qulipta 將在慢性偏頭痛預防市場中處於有利地位。在歐洲,我們繼續預計第三季度將批准 atogepant 作為慢性和發作性偏頭痛患者的預防性治療藥物。

  • Turning now to ABBV-951. We announced that we received a complete response letter for our regulatory application in the U.S. The FDA has not asked for additional efficacy or safety studies related to our drug delivery -- drug device delivery system, but rather they have requested additional information regarding the pump as well as updates to instruction for use. We are working to generate the necessary information, and we expect to respond to the CRL later this year with an FDA action anticipated in the first half of '24.

    現在轉向 ABBV-951。我們宣布,我們收到了一份針對我們在美國的監管申請的完整回复函。FDA 沒有要求對我們的藥物輸送——藥物設備輸送系統進行額外的療效或安全性研究,而是要求提供有關泵的額外信息,因為以及使用說明的更新。我們正在努力生成必要的信息,我們希望在今年晚些時候通過 FDA 預計在 24 年上半年採取的行動來回應 CRL。

  • In international markets, we've recently received approval for 951 in Japan, and we continue to expect approval in Europe in the fourth quarter of this year.

    在國際市場上,我們最近在日本獲得了 951 的批准,我們繼續期待今年第四季度在歐洲獲得批准。

  • In our early-stage neuroscience pipeline, we recently began Phase I studies of our selective D3 dopamine receptor agonist, ABBV-932. Our experience with Vraylar has highlighted the potential clinical benefit of achieving D3 selectivity, and we believe that a compound that more selectively engages the D3 dopamine receptor has the potential to provide enhanced efficacy. Our program will initially focus on general anxiety disorder with the potential to expand to other neuropsychiatric disorders.

    在我們的早期神經科學管道中,我們最近開始了選擇性 D3 多巴胺受體激動劑 ABBV-932 的 I 期研究。我們在 Vraylar 方面的經驗突出了實現 D3 選擇性的潛在臨床益處,我們相信一種更有選擇性地結合 D3 多巴胺受體的化合物有可能提供增強的療效。我們的計劃最初將側重於一般性焦慮症,並有可能擴展到其他神經精神疾病。

  • The programs under our collaboration with Calico are also progressing well. We now have 4 assets in clinical trials, including 2 PTPN2 inhibitors in Phase I in oncology. Our eIF2B activator for neurodegenerative diseases and an IGF-1 signaling pathway modulator that will be explored in aging-related diseases. Our most advanced program is the eIF2B activator 7262. The first patient was recently enrolled in the HEALEY ALS Platform Trial, a Phase II/III study conducted by the HEALEY Center for ALS at Mass General. This trial is designed to evaluate multiple therapies simultaneously with a goal to accelerate the development of potential breakthrough treatments for ALS.

    我們與 Calico 合作的項目也進展順利。我們現在有 4 項臨床試驗資產,包括腫瘤學 I 期的 2 種 PTPN2 抑製劑。我們用於神經退行性疾病的 eIF2B 激活劑和將在衰老相關疾病中探索的 IGF-1 信號通路調節劑。我們最先進的項目是 eIF2B 激活劑 7262。第一位患者最近參加了 HEALEY ALS 平台試驗,這是一項由 Mass General 的 HEALEY ALS 中心進行的 II/III 期研究。該試驗旨在同時評估多種療法,目的是加速 ALS 潛在突破性療法的開發。

  • Now I'd like to provide a brief update on 2 earlier stage programs in our therapeutic pipeline. In cystic fibrosis, we recently analyzed data from an ongoing proof-of-concept study, evaluating our triple combination therapy. The results from this interim analysis did not meet our criteria for advancing and we are discontinuing our cystic fibrosis program.

    現在我想簡要介紹一下我們治療管道中的 2 個早期項目。在囊性纖維化方面,我們最近分析了一項正在進行的概念驗證研究的數據,評估了我們的三聯療法。該中期分析的結果不符合我們的推進標準,我們將停止我們的囊性纖維化項目。

  • We also recently reviewed interim data from our exploratory studies for ABBV-154 in PMR in Crohn's disease. Similar to results from the RA study, while we observed efficacy with 154, we also observed some changes in biomarkers that are consistent with systemic steroid exposure at the higher doses. The benefit risk profile does not sufficiently differentiate 154 from other available treatments. So based on the totality of the data across RA, PMR and Crohn's disease studies, we will not be pursuing further development of this asset.

    我們最近還回顧了我們對克羅恩病 PMR 中 ABBV-154 探索性研究的中期數據。與 RA 研究的結果類似,雖然我們觀察到 154 的療效,但我們還觀察到生物標誌物的一些變化與較高劑量的全身類固醇暴露一致。收益風險概況不足以將 154 與其他可用治療區分開來。因此,基於 RA、PMR 和克羅恩病研究的全部數據,我們不會進一步開發該資產。

  • Now moving to our aesthetics pipeline. We recently saw data from our Phase III studies for Botox in platysma prominence and masseter muscle prominence. In our study for prominent neck muscles, Botox met all primary and secondary endpoints demonstrating a significant reduction in the unwanted appearance of platysma prominence on the neck and jaw line. This was the first of 3 Phase III studies in platysma prominence with data from the 2 remaining trials expected in the second half of the year, followed by regulatory submission in the U.S. near the end of 2023.

    現在轉向我們的美學管道。我們最近看到了肉毒桿菌素在頸闊肌突出和咬肌突出方面的 III 期研究數據。在我們針對突出的頸部肌肉的研究中,保妥適達到了所有主要和次要終點,表明頸部和下頜線上不希望出現的頸闊肌突出顯著減少。這是關於頸闊肌突出的 3 項 III 期研究中的第一項,其餘兩項試驗的數據預計將在今年下半年完成,隨後將在 2023 年底向美國提交監管申請。

  • Botox also performed very well in our study for prominent masseter muscles, meeting the primary and all secondary endpoints in the trial. Our program is initially focused on China and other Asian markets as masseter prominence is common in Asian populations and there is significant unmet need for minimally invasive treatment options. Based on the results from this trial, we expect to submit our regulatory application in China in the second half of the year. Once approved, we anticipate high demand for Botox in this novel indication, which will help to further build our portfolio in the lower phase segment.

    保妥適在我們針對突出的咬肌的研究中也表現出色,達到了試驗中的主要和所有次要終點。我們的項目最初專注於中國和其他亞洲市場,因為咬肌突出在亞洲人群中很常見,而且對微創治療方案的需求未得到滿足。根據此次試驗的結果,我們預計將於下半年在中國提交監管申請。一旦獲得批准,我們預計在這種新適應症中對保妥適的需求量很大,這將有助於進一步建立我們在後期階段的產品組合。

  • So in summary, we continue to demonstrate significant progress across all stages of our pipeline and anticipate numerous important regulatory and clinical milestones throughout the remainder of 2023.

    因此,總而言之,我們將繼續展示我們管道所有階段的重大進展,並預計在 2023 年剩餘時間內將出現許多重要的監管和臨床里程碑。

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

    有了這個,我會把電話轉給斯科特。

  • Scott T. Reents - Executive VP & CFO

    Scott T. Reents - Executive VP & CFO

  • Thank you, Tom. I will discuss our most recent financial results and guidance. Starting with our first quarter results, we delivered strong top and bottom line performance. We reported adjusted earnings per share of $2.46, which is $0.10 above our guidance midpoint. These results include an $0.08 unfavorable impact from acquired IPR&D expense. Total net revenues were $12.2 billion, $400 million ahead of our guidance and down 8.3% on an operational basis, excluding a 1.4% unfavorable impact from foreign exchange. The adjusted operating margin ratio was 45% of sales. This includes adjusted gross margin of 84.2% of sales, adjusted R&D investment of 13.6% of sales, acquired IPR&D expense of 1.2% of sales and adjusted SG&A expense of 24.4% of sales. Net interest expense was $454 million. The adjusted tax rate was 13.7%.

    謝謝你,湯姆。我將討論我們最近的財務結果和指導。從我們的第一季度業績開始,我們實現了強勁的頂線和底線業績。我們報告的調整後每股收益為 2.46 美元,比我們的指導中點高出 0.10 美元。這些結果包括 0.08 美元的收購 IPR&D 費用的不利影響。總淨收入為 122 億美元,比我們的指引高出 4 億美元,在運營基礎上下降 8.3%,不包括外匯帶來的 1.4% 的不利影響。調整後的營業利潤率為銷售額的 45%。這包括調整後的毛利率佔銷售額的 84.2%、調整後的研發投資佔銷售額的 13.6%、獲得的 IPR&D 費用佔銷售額的 1.2% 以及調整後的 SG&A 費用佔銷售額的 24.4%。淨利息支出為 4.54 億美元。調整後的稅率為 13.7%。

  • Turning to our financial outlook. We are raising our full year adjusted earnings per share guidance to between $10.72 and $11.12. This earning per share guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the first quarter. We now expect net revenues of approximately $52.4 billion, an increase of $400 million. At current rates, we expect foreign exchange to have a modest unfavorable impact on full year sales growth. This guidance includes the following updated assumptions. We now expect Vraylar sales of approximately $2.7 billion, an increase of $200 million, reflecting strong prescription growth following the MDD approval. And for aesthetics, we now expect global revenue of approximately $5.3 billion, reflecting the better-than-expected recovery in China and stable economic trends in the U.S.

    轉向我們的財務前景。我們將全年調整後每股收益指引上調至 10.72 美元至 11.12 美元之間。該每股收益指引不包括對第一季度之後可能發生的收購 IPR&D 費用的估計。我們現在預計淨收入約為 524 億美元,增加 4 億美元。按照目前的匯率,我們預計外匯會對全年銷售增長產生適度的不利影響。本指南包括以下更新的假設。我們現在預計 Vraylar 銷售額約為 27 億美元,增加 2 億美元,反映出 MDD 批准後處方藥的強勁增長。對於美學,我們現在預計全球收入約為 53 億美元,反映出中國好於預期的複蘇和美國穩定的經濟趨勢。

  • Turning to the second quarter, we anticipate net revenues of approximately $13.5 billion, which includes U.S. Humira erosion of 27%. At current rates, we expect foreign exchange to have a 0.6% unfavorable impact on sales growth. We are forecasting an adjusted operating margin ratio of 48.5% of sales. We are modeling a non-GAAP tax rate of 15.4%. We expect adjusted earnings per share between $2.90 and $3. This guidance does not include acquired IPR&D expense that may be incurred in the quarter.

    談到第二季度,我們預計淨收入約為 135 億美元,其中包括美國 Humira 侵蝕 27%。按照當前匯率,我們預計外匯會對銷售增長產生 0.6% 的不利影響。我們預測調整後的營業利潤率為銷售額的 48.5%。我們正在為 15.4% 的非 GAAP 稅率建模。我們預計調整後的每股收益在 2.90 美元至 3 美元之間。本指南不包括本季度可能發生的收購 IPR&D 費用。

  • In closing, we are off to an excellent start to the year with strong performance across the portfolio and financial results ahead of our expectations.

    最後,我們今年開局良好,整個投資組合的表現強勁,財務業績超出我們的預期。

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

    有了這個,我會把電話轉回給莉茲。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Scott. We will now open the call for questions. In the interest of hearing from as many analysts as possible over the remainder of the call, we ask that you please limit your questions to 1 or 2. Operator, first question, please.

    謝謝,斯科特。我們現在將開始提問。為了在接下來的電話會議中盡可能多地聽取分析師的意見,我們要求您將問題限制在 1 或 2 個以內。接線員,請問第一個問題。

  • Operator

    Operator

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

    我們的第一個問題來自摩根士丹利的 Terence Flynn。

  • Terence C. Flynn - Equity Analyst

    Terence C. Flynn - Equity Analyst

  • Great. Maybe 2 for me. Just on immunology, can you quantify the amount of destocking for both Skyrizi and Rinvoq in the quarter? I think Biogen on their call spoke to some tighter working capital requirements at wholesalers due to rising interest rates. So just wondering if you're seeing something similar here and just to want to be sure that it's not a pricing dynamic. And then can you elaborate at all about your ALS program when we might see some data there?

    偉大的。也許2對我來說。就免疫學而言,您能否量化一下本季度Skyrizi和Rinvoq的去庫存量?我認為百健(Biogen)在他們的電話會議上談到了由於利率上升而對批發商提出的一些更嚴格的營運資金要求。所以只是想知道您是否在這裡看到類似的東西,只是想確保它不是定價動態。那麼當我們在那裡看到一些數據時,您能否詳細說明您的 ALS 計劃?

  • Robert A. Michael - Vice Chairman & President

    Robert A. Michael - Vice Chairman & President

  • Terence, it's Rob. So on the retail inventory destocking, we do typically see this in the first quarter, so it wasn't a complete surprise. In fact, it was factored into our guidance. We did beat our guidance in immunology for the quarter. The impact was high single digits, both for Skyrizi and Rinvoq. In terms of absolute value, we're talking about around $70 million for Skyrizi and $30 million for Rinvoq.

    特倫斯,是羅布。因此,在零售庫存去庫存方面,我們通常會在第一季度看到這種情況,所以這並不完全出乎意料。事實上,它已被納入我們的指南。本季度我們確實超出了我們在免疫學方面的指導。 Skyrizi 和 Rinvoq 的影響都是高個位數。就絕對價值而言,我們談論的 Skyrizi 約為 7000 萬美元,Rinvoq 約為 3000 萬美元。

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • And it's Jeff. Just to clarify on your wholesale comment, I think, as Rob highlighted, it's in the retail. So it's in the specialty pharmacy channel. And you'll recall, as you know, there's about 18 specialty pharmacies that basically distribute the I&I products, and there are some big ones there. So it was not a wholesaler dynamic. It was a retail inventory dynamic, which, again, as these products get bigger, we do see and contemplate in our projections.

    是傑夫。只是為了澄清你的批發評論,我認為,正如 Rob 強調的那樣,它在零售中。所以它在專業藥房渠道。你會記得,正如你所知,大約有 18 家專業藥店基本上分銷 I&I 產品,那裡有一些大藥房。所以這不是批發商動態。這是一種零售庫存動態,隨著這些產品變得越來越大,我們確實在我們的預測中看到並考慮到了這一點。

  • Robert A. Michael - Vice Chairman & President

    Robert A. Michael - Vice Chairman & President

  • And then Terence, this is Rob. Just to more broadly answer the question that I'm sure many investors have. If you look at the growth in the quarter, so overall, U.S. demand was up just north of 60% for Rinvoq and Skyrizi. We saw very strong performance across all approved indications, as Jeff highlighted. We did have the 2 partial offsets, one being the retail inventory destock, which I've already quantified. And then price was down high single digits and that's really driven by rebate increases, which is typical when we see the type of volume increase.

    然後是 Terence,這是 Rob。只是為了更廣泛地回答我相信很多投資者都有的問題。如果你看一下本季度的增長,那麼總體而言,美國對 Rinvoq 和 Skyrizi 的需求增長了 60% 以上。正如 Jeff 強調的那樣,我們在所有批准的適應症中都看到了非常強勁的表現。我們確實有 2 個部分抵消,一個是零售庫存去庫存,我已經量化了。然後價格下降了高個位數,這實際上是由回扣增加推動的,這在我們看到數量增加的類型時很典型。

  • And we saw Skyrizi sales up 80% last year, Rinvoq in the U.S. up 40% last year. So when you see that kind of volume growth and couple that with the number of indications we had approved, we had 5 new indications for Rinvoq and 2 for Skyrizi. So it was something we were contemplating. It was factored into our guidance, but I don't know that The Street fully appreciated that in terms of the first quarter estimates that were put out there.

    我們看到 Skyrizi 去年的銷售額增長了 80%,美國的 Rinvoq 去年增長了 40%。因此,當你看到這種銷量增長並將其與我們批准的適應症數量相結合時,我們有 5 個新的 Rinvoq 適應症和 2 個 Skyrizi 新適應症。所以這是我們正在考慮的事情。它已被納入我們的指導方針,但我不知道華爾街在第一季度的估計中是否完全理解這一點。

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

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

  • This is Tom for the ALS question. I'd say about 2 years, we had to recruit the patients and there's about a year of follow-up that is needed. So I would say, late '24, early '25, all depends on the enrollment, which I understand is starting off on a good pace.

    我是湯姆,負責 ALS 問題。我想說大約 2 年,我們必須招募患者,並且需要大約一年的隨訪。所以我想說,24 年底,25 年初,一切都取決於入學人數,據我所知,這是一個良好的開端。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Terence. Operator, next question, please.

    謝謝,特倫斯。接線員,請問下一個問題。

  • Operator

    Operator

  • Our next question comes from Steve Scala with Cowen.

    我們的下一個問題來自 Steve Scala 和 Cowen。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • A couple of questions. Some of your peers have called out co-pay resets early in the year that have led to more modest performances in products such as Dupixent and Cosentyx. AbbVie has been less vocal on this point. How much was that a factor? Or are Skyrizi and Rinvoq different in some way? And then secondly, despite the solid performance in Q1, the EPS guidance range continues to be very wide. What factors would have to play out for you to hit the high end of that and the low end of that?

    幾個問題。你的一些同行在今年年初呼籲重新設置共同支付,這導致 Dupixent 和 Cosentyx 等產品的表現更為溫和。艾伯維(AbbVie)在這一點上一直不那麼直言不諱。這是一個多大的因素?或者 Skyrizi 和 Rinvoq 在某些方面有所不同?其次,儘管第一季度表現穩健,但 EPS 指導範圍仍然非常廣泛。哪些因素必鬚髮揮作用才能使您達到高端和低端?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes, Steve, it's Jeff, and thanks for the question. I'll take the co-pay one. Look, I mean, some of the peers are seeing the effects of the so-called maximizer programs or even some of the lingering accumulator programs which do sometimes as benefit designs are reset in the first quarter can apply some pressure. We don't see that. We've been managing that very tightly. And we're not seeing any significant sort of surge or creep in terms of that dynamic. The dynamic is exactly what Rob had highlighted, which is the modest price based on the number of indications and how fast the volume is moving and this destocking event that we talked through. So co-pay is very stable for AbbVie.

    是的,史蒂夫,我是傑夫,謝謝你提出這個問題。我會接受共付額。看,我的意思是,一些同行正在看到所謂的最大化程序的效果,甚至一些揮之不去的累加器程序有時會在第一季度重新設置福利設計時會施加一些壓力。我們看不到這一點。我們一直在非常嚴格地管理它。就這種動態而言,我們沒有看到任何明顯的激增或蠕變。這種動態正是 Rob 所強調的,這是基於跡象的數量和交易量移動的速度以及我們討論過的這個去庫存事件的適度價格。因此,艾伯維的共付額非常穩定。

  • Robert A. Michael - Vice Chairman & President

    Robert A. Michael - Vice Chairman & President

  • And Steve, this is Rob, on your EPS range question. We've typically given a $0.20 range; this year, we gave a $0.40 range. And the key driver of that is obviously the U.S. Humira dynamics. As we see that play out, particularly in the second half, we would typically tighten that range. Now keep in mind, that $0.20 wider range represents about 1% of U.S. Humira growth. So it's not as wide as you might think. But we did widen it given the dynamics of U.S. Humira. And I think we'll be able to give you more color as we see those 7, 9 biosimilars coming in the market in the middle of the year. We'll have more clarity for you on the second quarter call.

    史蒂夫,這是羅布,關於你的 EPS 範圍問題。我們通常給出 0.20 美元的範圍;今年,我們給出了 0.40 美元的區間。而其中的關鍵驅動因素顯然是美國 Humira 的動態。當我們看到這種情況發生時,尤其是在下半場,我們通常會收緊該範圍。現在請記住,0.20 美元的更寬範圍代表了美國 Humira 增長的 1% 左右。所以它並不像你想像的那麼廣泛。但考慮到美國 Humira 的動態,我們確實擴大了它。我認為,當我們看到年中有 7 種、9 種生物仿製藥進入市場時,我們將能夠為您提供更多的顏色。我們將在第二季度電話會議上為您提供更清晰的信息。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Steve. Operator, next question, please.

    謝謝,史蒂夫。接線員,請問下一個問題。

  • 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 Chris Schott。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Just coming back to Skyrizi and Rinvoq, I think you mentioned high single-digit price erosion beyond just those inventory changes. I guess is that a reasonable assumption to think about price as we progress through the rest of this year? And then maybe longer term, should we think about that level of price erosion as more like a onetime kind of issue this year given all the new indications and a more stable trend going forward? I'm just trying to kind of get my hands around the pricing a little bit more.

    回到 Skyrizi 和 Rinvoq,我想你提到了高個位數的價格侵蝕,而不僅僅是那些庫存變化。我想隨著今年剩餘時間的進展,考慮價格是否是一個合理的假設?然後也許從長遠來看,考慮到所有新的跡象和未來更穩定的趨勢,我們是否應該將這種價格侵蝕程度視為今年的一次性問題?我只是想多了解一下定價。

  • And my second question was on the aesthetics business. You obviously saw a very strong 1Q. Can you just elaborate a little bit more on your confidence in the sustainability of these trends? I know the market has been a little bit bumpy, but it seems like the tone is that you're encouraged with the trends you're seeing. But just how much, I guess, visibility you have in terms of sustainability of those favorable international trends we're seeing right now?

    我的第二個問題是關於美學業務的。您顯然看到了非常強勁的 1Q。您能否更詳細地說明您對這些趨勢的可持續性的信心?我知道市場有點顛簸,但似乎基調是你對所看到的趨勢感到鼓舞。但我想,就我們現在看到的那些有利的國際趨勢的可持續性而言,您有多少能見度?

  • Robert A. Michael - Vice Chairman & President

    Robert A. Michael - Vice Chairman & President

  • Chris, this is Rob. So on your question on price, yes, the way to think about 2023 price for the year for Skyrizi and Rinvoq would be down high single digits. Now we wouldn't expect high single digits to be the rate going forward given a big driver was the number of new indications that we launched. And so I would expect that to moderate over time.

    克里斯,這是羅伯。所以關於你關於價格的問題,是的,考慮 Skyrizi 和 Rinvoq 的 2023 年價格的方式是下降高個位數。現在我們不希望高個位數成為未來的增長率,因為一個重要的驅動因素是我們推出的新適應症的數量。所以我希望隨著時間的推移緩和。

  • Carrie?

    嘉莉?

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

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

  • This is Carrie. In terms of your questions around the aesthetics market, there are 2 key assumptions for the 2023 planning. One was around the U.S. economy and the other was around the recovery in China. When you think about the U.S. economy, we look at Q1 and we see some favorability to our planning assumptions with the metrics that we track, which Rob mentioned, include real personal consumption expenditure and Google.

    這是嘉莉。就您圍繞美學市場提出的問題而言,2023 年規劃有兩個關鍵假設。一個是圍繞美國經濟,另一個是圍繞中國的複蘇。當你考慮美國經濟時,我們看一下第一季度,我們看到我們跟踪的指標對我們的計劃假設有一些支持,羅伯提到,包括實際個人消費支出和谷歌。

  • And so in January and February, we saw favorability there. Although in March, there are some potential signs of softening. So we continue to have a cautious outlook for our U.S. business for the rest of the year. The way to think about market growth for the full year would be low -- for toxins, the market would be down low to mid-single digits until we lap the 2022 downturn, which happened around May. And then after that, we would expect flat market growth for the rest of the year. So that's how we think about the U.S.

    所以在 1 月和 2 月,我們在那裡看到了好感度。儘管在 3 月,有一些潛在的軟化跡象。因此,我們對今年剩餘時間的美國業務前景持謹慎態度。考慮全年市場增長的方式是低的——對於毒素,市場將下降到中個位數,直到我們在 2022 年的低迷時期結束,這發生在 5 月左右。然後在那之後,我們預計今年剩餘時間市場增長將持平。這就是我們對美國的看法

  • Our other -- our second biggest market is China. And recall, we had assumed that the aesthetics market in China would not recall -- would not fully recover until the second half of the year. Well, in actuality, what we saw was although January was significantly impacted, in February, we started to see improvement. And in March, there was a really steep recovery that we do expect will sustain through the rest of the year. And in other markets around the world, I guess, in Canada and U.K., we are seeing some high inflation impacting consumer demand, but the rest of Europe seems stable right now.

    我們的另一個 - 我們的第二大市場是中國。回想一下,我們曾假設中國的美容市場不會回想——要到今年下半年才能完全恢復。好吧,實際上,我們看到的是,雖然 1 月份受到了重大影響,但在 2 月份,我們開始看到改善。而在 3 月份,出現了非常急劇的複蘇,我們確實預計這一複蘇將持續到今年餘下的時間。在世界其他市場,我猜,在加拿大和英國,我們看到一些高通脹影響了消費者需求,但歐洲其他國家目前似乎很穩定。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thank you, Chris. Operator, next question, please.

    謝謝你,克里斯。接線員,請問下一個問題。

  • Operator

    Operator

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

    我們的下一個問題來自 Wells Fargo 的 Mohit Bansal。

  • Mohit Bansal - Senior Equity Analyst

    Mohit Bansal - Senior Equity Analyst

  • I have one clarification and one question. So clarification is regarding the price decline for I&I. You said that high single digit, but should we assume like going forward, year-over-year, we should -- versus volumes, should we assume high single-digit decline still going forward for at least for rest of the quarter and then more stable pricing quarter-over-quarter term, just that clarification.

    我有一個澄清和一個問題。所以澄清是關於 I&I 的價格下降。你說的是高個位數,但我們應該假設像往年一樣,與去年同期相比,我們應該 - 與交易量相比,我們是否應該假設至少在本季度剩餘時間甚至更多時間內仍會出現高個位數下降穩定的季度定價,只是澄清一下。

  • And the question is, regarding the I&I pipeline, so you have a leadership position with Skyrizi and Rinvoq, and they are growing. But some of the pipeline products like 154 and 157 did not pan out as you were hoping them to. So what is -- how should we think about the pipeline strategy beyond these 2 products? And can you even do M&A given the increased FTC scrutiny nowadays?

    問題是,關於 I&I 管道,你在 Skyrizi 和 Rinvoq 中處於領先地位,而且它們正在成長。但是一些管道產品,如 154 和 157,並沒有像您希望的那樣成功。那麼什麼是——我們應該如何考慮這兩種產品之外的管道戰略?鑑於如今 FTC 的審查越來越嚴格,您甚至可以進行併購嗎?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • So this is Rick. I'll cover number two and maybe just touch on number one. If you think about our pipeline, obviously, as we look at Skyrizi and Rinvoq, they clearly have restated the immunology market across most of the segments that we operate in. We view those assets as being able to drive strong growth through the early part of the next decade.

    這就是瑞克。我將介紹第二點,也許只涉及第一點。如果你想想我們的產品線,很明顯,當我們看到 Skyrizi 和 Rinvoq 時,他們顯然已經重申了我們經營的大部分細分市場的免疫學市場。我們認為這些資產能夠在早期推動強勁增長下一個十年。

  • Having said that, we're continuing to look for assets in areas where we believe there's still a significant opportunity to restate standard of care. And we obviously explore, as everyone in this industry does many different assets and different mechanisms to try to find those kinds of mechanisms that will deliver that kind of performance. It's interesting. When you look at the 154 platform, it did exactly what we thought it would do from the standpoint of efficacy. But it did it in a way only at the highest dose and at that highest dose, we did see it -- some effects of steroids on some of the biomarkers. And based on the way we think regulators would look at a label for those kinds of products, we didn't believe that would be a competitive profile.

    話雖如此,我們將繼續在我們認為仍有重要機會重申護理標準的領域尋找資產。我們顯然在探索,因為這個行業的每個人都在做許多不同的資產和不同的機制,試圖找到能夠提供那種性能的那些機制。這真有趣。當您查看 154 平台時,從功效的角度來看,它完全符合我們的預期。但它只在最高劑量和最高劑量下以某種方式做到了,我們確實看到了——類固醇對某些生物標誌物的一些影響。根據我們認為監管機構會查看此類產品標籤的方式,我們認為這不會成為具有競爭力的形象。

  • But the hypothesis certainly worked around the mechanism. So we continue to look for opportunities. We have lots of runway here to be able to get to those, but we do desire to find some additional mechanisms that will be the follow-on products that should be introduced hopefully near the end of this decade or early into the next decade as the next-generation immunology assets for AbbVie. So -- and I feel good about the progress that we're making there. We're continuing to explore a number of other areas. And we're continuing to look both internally and externally at different assets that we can bring into the company to be able to do that.

    但這個假設肯定圍繞著這個機制起作用。所以我們繼續尋找機會。我們在這裡有很多跑道可以實現這些目標,但我們確實希望找到一些額外的機制,這些機制將成為後續產品,有望在本十年末或下一個十年初推出,因為艾伯維的下一代免疫學資產。所以 - 我對我們在那裡取得的進展感到滿意。我們正在繼續探索其他一些領域。我們將繼續在內部和外部尋找不同的資產,我們可以將這些資產帶入公司,以便能夠做到這一點。

  • To your question of being able to bring assets into this market, we don't believe that we would be encumbered because immunology is a very crowded space from a competitive standpoint. And that's one of the most important criteria that you look at from an FTC standpoint. So we believe we have freedom to operate across most of those segments from an FTC standpoint as well.

    對於能夠將資產帶入這個市場的問題,我們認為我們不會受到阻礙,因為從競爭的角度來看,免疫學是一個非常擁擠的領域。從 FTC 的角度來看,這是最重要的標準之一。因此,我們相信,從 FTC 的角度來看,我們也可以自由地在其中大部分領域開展業務。

  • And on price, maybe Rob and I will tag team this one to make sure it's clear. It is common that when you go out and you add indications in this industry, that when you negotiate those contracts to be able to get access, it does require some level of price concession. I would say we're on the lower end of what you typically would have seen with the speed at which we got access for Skyrizi and Rinvoq for those indications and the breadth of that access. And so we certainly would expect this year and last year to be the areas where you saw the most significant amount of price because those are the years that we added the majority of the indications, you would expect that to moderate.

    在價格上,也許 Rob 和我會標記這個團隊以確保它是明確的。很常見的是,當你走出去並在這個行業中添加跡象時,當你談判這些合同才能獲得准入時,確實需要一定程度的價格讓步。我想說的是,我們在訪問 Skyrizi 和 Rinvoq 以獲得這些適應症的速度和訪問的廣度方面,處於你通常會看到的速度的低端。因此,我們當然希望今年和去年成為您看到價格最高的地區,因為那是我們添加了大部分跡象的年份,您會期望這種情況會緩和。

  • So then going forward, the way to think about it is, then it's only really driven by volume at that point. And volume typically requires much more modest kinds of price as you go forward. It's not 0 price. You shouldn't have that expectation. But I would not have an expectation of high single digits going forward.

    因此,展望未來,思考它的方式是,那時它只是真正由數量驅動。隨著您的前進,數量通常需要更適中的價格。不是0價。你不應該有這樣的期望。但我不希望未來出現高個位數。

  • Anything you'd add, Rob?

    羅伯,你有什麼要補充的嗎?

  • Robert A. Michael - Vice Chairman & President

    Robert A. Michael - Vice Chairman & President

  • Just to answer the question, Mohit, on the gating. Yes, I think it's safe to assume that you'll see high single-digit price in each of the quarters this year.

    只是為了回答問題,莫希特,關於門控。是的,我認為可以安全地假設你會在今年每個季度看到高個位數的價格。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thank you, Mohit. Operator, next question, please.

    謝謝你,莫希特。接線員,請問下一個問題。

  • Operator

    Operator

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

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

  • Alice Jennifer Nettleton - Research Analyst

    Alice Jennifer Nettleton - Research Analyst

  • This is Alice Nettleton on for Tim Anderson. So a question on PBMs, which are under renewed scrutiny. If there were material changes to the rebating structure currently in place, would that put big incumbent products at risk because it might remove the so-called rebate wall? And more generally, do you think there is any chance of some of the proposed legislative changes actually becoming law? And then secondly, any collateral impact you're seeing on Skyrizi or Rinvoq since Humira biosimilars have launched? And given the overlapping indications, do you think that you'll start to see some picking off of patients from these 2 brands to biosimilars in the second half of the year?

    這是蒂姆安德森的愛麗絲內特爾頓。所以關於 PBM 的問題,正在接受重新審查。如果當前的回扣結構發生實質性變化,是否會使現有的大型產品面臨風險,因為它可能會移除所謂的回扣牆?更一般地說,您認為某些擬議的立法變更是否有可能真正成為法律?其次,自 Humira 生物仿製藥推出以來,您對 Skyrizi 或 Rinvoq 有什麼附帶影響?考慮到重疊的適應症,你認為你會在今年下半年開始看到一些患者從這兩個品牌轉向生物仿製藥嗎?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes, it's Jeff. I'll give some comment on that. I think the way that we think about our brands is the first place that we look at is how distinctive they are. I mean we've got 4 head-to-head trials with Skyrizi and another one on the way where we can clearly differentiate the product. And we have many as well on Rinvoq. So we've really thought about it from a development standpoint. And I would say the perspective is somehow there was a restructuring of the PDMs, which I don't think is imminent. And the rebate sort of approach disappeared. It disappears for everybody. I mean all of these I&I products have a fairly reasonable rebate load and there would be a different basis of competition, which we would do very, very well. So we're not concerned about sort of a fundamental structural change relative to these 2 products, which are very distinctive.

    是的,是傑夫。我將對此發表一些評論。我認為我們看待品牌的方式首先是看它們的獨特性。我的意思是,我們已經與 Skyrizi 進行了 4 次面對面的試驗,而另一項試驗正在進行中,我們可以清楚地區分產品。我們在 Rinvoq 上也有很多。所以我們真的從發展的角度考慮過它。我想說的是,PDM 以某種方式進行了重組,我認為這不會迫在眉睫。並且回扣類方法消失了。它對每個人都消失了。我的意思是所有這些 I&I 產品都有相當合理的回扣負載,並且會有不同的競爭基礎,我們會做得非常非常好。因此,我們並不擔心與這兩種非常獨特的產品相關的基本結構變化。

  • If we look at your second part of your question, which is it's really the same answer, which is we don't see that there are going to be significant impacts of Humira biosimilars on the performance of Skyrizi and Rinvoq. And one perspective, let's take Rinvoq is sort of a very simple way of thinking about it. It's already in the United States, a step behind TNF and it's performing at that level because you see such expansion of second and third lines in that space. And Skyrizi is very, very distinctive. So no, in the second half, we do not anticipate sort of a knock-on effect of the emergent biosimilars to our 2 core brands.

    如果我們看一下你問題的第二部分,那就是它實際上是相同的答案,我們認為 Humira 生物仿製藥不會對 Skyrizi 和 Rinvoq 的性能產生重大影響。從一個角度來看,讓我們以 Rinvoq 為例,這是一種非常簡單的思考方式。它已經在美國,落後於 TNF 一步,並且它在那個水平上表現,因為你看到該空間中二線和三線的擴張。 Skyrizi 非常非常有特色。所以不,在下半年,我們預計新興生物仿製藥不會對我們的兩個核心品牌產生連鎖反應。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Alice. Operator, next question, please.

    謝謝,愛麗絲。接線員,請問下一個問題。

  • Operator

    Operator

  • Our next question comes from Carter Gould with Barclays.

    我們的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

  • Maybe a different spin on sort of the BE question there, just given sort of the volatility in the marketplace, as you kind of have those conversations or engage with potential targets. Just if you've seen a shift in sort of that bid-ask spread and the willingness of boards and management to consider deals. Any update on that front would be helpful.

    也許對那裡的 BE 問題有不同的看法,只是考慮到市場的波動性,當你進行這些對話或與潛在目標接觸時。只要您看到這種買賣差價發生變化,以及董事會和管理層考慮交易的意願就會發生變化。這方面的任何更新都會有所幫助。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • This is Rick. I'd say the environment hasn't changed materially in the last 24 months from my perspective. I still think it's certainly more difficult to raise money for biotech companies. So it probably makes them a bit more willing to engage with players like us or engage in a process, if they're at a point where they've generated data that makes them attractive. But I'd say the interest level in that engagement is similar to what has been for the last 12 to 24 months. And there's a lot of opportunity to be able to find assets that are in the biotech area. The question is you have to find the right kind of asset and you have to find one that's attractive and meet your needs. And I'd say being able to negotiate a transaction, I think, is a reasonable probability.

    這是瑞克。我想說,從我的角度來看,過去 24 個月環境沒有發生重大變化。我仍然認為為生物技術公司籌集資金肯定更加困難。因此,如果他們處於生成使他們具有吸引力的數據的地步,這可能會讓他們更願意與像我們這樣的玩家互動或參與流程。但我想說這種參與的興趣水平與過去 12 到 24 個月的水平相似。並且有很多機會能夠找到生物技術領域的資產。問題是您必須找到合適的資產類型,並且必須找到具有吸引力並滿足您需求的資產。我想說,我認為能夠通過談判達成交易是一種合理的可能性。

  • I'd say prices are still relatively high. And so valuations for good assets tend to go at a pretty high level. So again, it's got to be an asset that can demonstrate that it's going to provide significant value to justify that kind of a valuation and a return. But we continue to look for opportunities. And I think as we find those kinds of opportunities, as I've said in the past, we're certainly going to pursue them.

    我會說價格仍然相對較高。因此,優質資產的估值往往處於相當高的水平。因此,它必須是一種資產,可以證明它將提供重要的價值來證明這種估值和回報的合理性。但我們繼續尋找機會。我認為,正如我過去所說,當我們找到這些機會時,我們肯定會抓住它們。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Carter. Operator next question, please.

    謝謝,卡特。請接線員回答下一個問題。

  • Operator

    Operator

  • Our next question comes from Vamil Divan with Guggenheim Securities.

    我們的下一個問題來自古根海姆證券公司的 Vamil Divan。

  • Vamil Kishore Divan - Research Analyst

    Vamil Kishore Divan - Research Analyst

  • Maybe a couple from me as well. So one, just a couple of data points you have coming up this year that I think may be a little bit less focused on is on Navitoclax and Teliso-V. So maybe you can just sort of frame so what we should be looking for, what your expectations are, what you're hoping to see from those assets, especially Teliso-V given your comments on the sort of next-gen ABBV-400?

    也許我也有一對。所以,今年你提出的幾個數據點,我認為可能不太關注 Navitoclax 和 Teliso-V。因此,也許您可以對框架進行排序,以便我們應該尋找什麼,您的期望是什麼,您希望從這些資產中看到什麼,特別是 Teliso-V,考慮到您對下一代 ABBV-400 的評論?

  • And then the other question, I guess, would be for Rick and is more on succession planning. I know we've talked -- you've mentioned before that your plans to stick around through the Humira bench. I'm just wondering if you have any sort of updated sort of thoughts around timing on that now that we're in the middle of this process. We've been getting some questions there, too. Is this something we should expect some sort of announcement this year? Or is it more -- are you're looking for 2024 or later?

    然後另一個問題,我想,是給里克的,更多的是關於繼任計劃。我知道我們已經談過了——你之前提到過你計劃在 Humira 替補席上堅持下去。我只是想知道,既然我們正處於這個過程中,您是否對時間安排有任何更新的想法。我們也在那裡收到了一些問題。這是我們今年應該期待的某種公告嗎?還是更多——你在尋找 2024 年或更晚的時間?

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

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

  • It's Roopal. I'll take the ones on Navitoclax and Teliso-V. So for Navitoclax, it's the combination with the JAK2 in myelofibrosis. And there, we're looking to be better than monotherapy with JAK2 in that space and improving spleen size and symptoms like abdominal pain, fullness, fever, fatigue. Also, perhaps uniquely, what we've observed is also an improvement in bone marrow fibrosis and a decrease in variant allelic frequency. So that's what we would be looking for, and we should get a readout by midyear or so.

    是魯帕爾。我將使用 Navitoclax 和 Teliso-V 上的那些。因此,對於 Navitoclax,它與骨髓纖維化中的 JAK2 聯合使用。在那裡,我們正在尋找比 JAK2 在那個空間的單一療法更好的方法,並改善脾臟大小和腹痛、飽腹感、發燒、疲勞等症狀。此外,也許是獨一無二的,我們觀察到的還有骨髓纖維化的改善和變異等位基因頻率的降低。所以這就是我們要尋找的,我們應該在年中左右得到一個讀數。

  • For Teliso-V, in lung cancer, EGFR wild type with high c-Met and that's the indication where we have breakthrough therapy designation. Around the end of this year, I would say that's where we would see a readout. What we've seen in earlier data cuts is an ORR above 50%, which is quite a bit higher than what would be expected in standard of care in that second, third line setting. And if the data looks strong, there's a potential that we could submit next year for an accelerated approval.

    對於 Teliso-V,在肺癌中,具有高 c-Met 的 EGFR 野生型,這就是我們獲得突破性治療指定的適應症。大約在今年年底,我會說那是我們會看到讀數的地方。我們在早期數據削減中看到的 ORR 高於 50%,這比第二、第三線設置中護理標準的預期要高很多。如果數據看起來不錯,我們有可能在明年提交加速批准。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • I'll take the second question. And maybe I'll make a little bit of a comment on Teliso-V because I think you mentioned 400. I think the early data that we're seeing in 400 is impressive to us. There's no question about it. And I think we're going to have some data presented at this ASCO, right, where you'll have an opportunity to see that in CRC.

    我來回答第二個問題。也許我會對 Teliso-V 做一點評論,因為我認為你提到了 400。我認為我們在 400 中看到的早期數據給我們留下了深刻的印象。毫無疑問。我認為我們將在本次 ASCO 上展示一些數據,您將有機會在 CRC 中看到這些數據。

  • Now having said that, Teliso-V, as Roopal said, does get very good responses in c-Met highs. But to get a broader set of c-MET population, we do believe you need to move to the Topol warhead and seems to get deeper responses and more durable responses.

    話雖如此,正如 Roopal 所說,Teliso-V 確實在 c-Met highs 中獲得了很好的響應。但要獲得更廣泛的 c-MET 人群,我們確實認為您需要轉向白楊彈頭,並且似乎獲得更深入的反應和更持久的反應。

  • Data has to play out over time, but it appears to be a very good platform for c-MET. And so we need the data to mature, and we need to develop more data in that area. But I'd say the early data is pretty encouraging. You'll have a chance to see a snippet of that at this ASCO.

    數據必須隨著時間的推移而發揮作用,但它似乎是 c-MET 的一個非常好的平台。因此,我們需要數據成熟,我們需要在該領域開發更多數據。但我要說的是,早期數據非常令人鼓舞。您將有機會在本次 ASCO 上看到其中的片段。

  • As far as leadership changes, I'd say it's similar to what we've said in the first quarter or fourth quarter, I can't recall, last year around succession. We obviously have a process in place. We have a very experienced board. I've had many, many discussions with the Board about succession. The Board knows I'm committed to be here to ensure a successful and smooth transition. The criteria that we're operating against is we need to completely get through the transition for Humira biosimilars here in the U.S.

    就領導層變動而言,我想說這與我們在第一季度或第四季度所說的類似,我不記得去年的繼任情況。我們顯然有一個流程。我們有一個非常有經驗的董事會。我與董事會就繼任問題進行了很多很多討論。董事會知道我致力於確保成功和平穩的交接。我們所反對的標準是我們需要在美國完全完成 Humira 生物仿製藥的過渡。

  • I'd say, so far, I'm pretty pleased with how the transition is going. And I'm even more pleased with the way the growth platform is operating right now. And in fact, if you look at it this year, the growth platform is going to deliver mid-single digits and it's going to do it despite the headwinds that we see on Imbruvica and the headwinds that we're seeing from the economy on aesthetics. Once the aesthetics business returns to its normal growth rates and much of the pressure on Imbruvica starts to subside, we should see that growth rate increase significantly as we move into '24 for the growth platform.

    我想說,到目前為止,我對過渡的進展情況非常滿意。我對增長平台目前的運作方式更加滿意。事實上,如果你看看今年,增長平台將實現中等個位數的增長,儘管我們在 Imbruvica 上看到了逆風,而且我們在經濟上看到了美學上的逆風,但它還是會做到這一點.一旦美容業務恢復到正常增長率並且 Imbruvica 的大部分壓力開始消退,隨著我們進入增長平台的 24 世紀,我們應該會看到增長率顯著增加。

  • And obviously, returning to robust growth in '25 and deliver high single digit from that point forward. So that's the expectation that we're working against. So we want to make sure that the business is operating the way we want it to. We want to make sure that we're through the biosimilar erosion to the point that we believe it is predictable.

    顯然,在 25 年恢復強勁增長,並從那時起實現高個位數。所以這就是我們正在努力的期望。因此,我們要確保業務按照我們希望的方式運營。我們想確保我們已經度過了生物仿製藥的侵蝕期,達到我們認為可以預測的程度。

  • And then obviously, the second part of the criteria is ensuring that the candidate that will succeed me is ready to do that. We can make a successful transition. I've also told the Board that I'm willing to stay in any capacity that they would desire for whatever length of time they would. I think the expectation right now is that I would assume the Executive Chairman role for a period of time to finish the transition to the new CEO. You should not be expecting that, that transition is going to occur in '23.

    顯然,標準的第二部分是確保接替我的候選人準備好這樣做。我們可以成功過渡。我還告訴董事會,我願意以他們希望的任何身份留任多久。我認為現在的期望是我將擔任一段時間的執行主席,以完成向新 CEO 的過渡。您不應該期望這種轉變會在 23 年發生。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Vamil. Operator, next question, please.

    謝謝,瓦米爾。接線員,請問下一個問題。

  • Operator

    Operator

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

    我們的下一個問題來自 BMO Capital Markets 的 Evan Seigerman。

  • Evan David Seigerman - MD & Senior BioPharma Research Analyst

    Evan David Seigerman - MD & Senior BioPharma Research Analyst

  • Just on kind of Skyrizi and some of the dynamics you're seeing there, can you characterize about kind of how you're thinking about further penetration in the psoriasis indication, kind of some puts and takes in the dermatology market? And just a follow-up on the CF program, is it safe to assume that you're totally done investing in this area? Or do you have other assets kind of in earlier development that could emerge?

    就 Skyrizi 和你在那裡看到的一些動態而言,你能描述一下你是如何考慮進一步滲透牛皮癬適應症的,以及皮膚病學市場的一些投資和收購嗎?只是 CF 計劃的後續行動,是否可以安全地假設您已完全完成對該領域的投資?或者您是否有可能出現的早期開發中的其他資產?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. It's Jeff. I'll take your comment on psoriasis. I think that, as I mentioned, it's -- the share is very, very impressive. So we have a 30% total market share now which is really putting significant headroom against any other drug in that category by a lot. And one way to think about it is, I think what you're asking is how much further can it run? And it can run quite a bit further. To some degree, if you think about it, so we're capturing on the dynamic share roughly 50%. So 1 out of every 2 patients. And our market share is about 30.

    是的。是傑夫。我會接受你對牛皮癬的評論。我認為,正如我所提到的,它的份額非常非常令人印象深刻。因此,我們現在擁有 30% 的總市場份額,這確實為該類別中的任何其他藥物提供了很大的空間。一種思考方式是,我想你問的是它還能跑多遠?它可以跑得更遠。在某種程度上,如果你考慮一下,那麼我們捕獲了大約 50% 的動態份額。所以每 2 名患者中就有 1 名。我們的市場份額約為 30。

  • So theoretically, over time, right, unless there's some disruption, which we don't see significant disruption in the market, your total market share is going to move towards that in-play share. Now that takes many, many years. But as we look at the fundamental momentum that we can achieve, it's still very, very significant. Add on to that, that basically, we're still in the rest of the world, starting to really see the PSA ramp. And remember, PSA has a very significant impact because it's treated by derms and it was sort of the last remaining gap that we had, so you're going to see continued momentum in the international markets and the U.S. market and we have a long way to run.

    因此,從理論上講,隨著時間的推移,除非出現一些中斷,我們沒有看到市場出現重大中斷,否則您的總市場份額將朝著實際份額移動。現在這需要很多很多年。但當我們審視我們可以實現的基本勢頭時,它仍然非常非常重要。除此之外,基本上,我們仍在世界其他地方,開始真正看到 PSA 的增長。請記住,PSA 具有非常重要的影響,因為它經過真皮處理,這是我們最後剩下的差距,所以你會看到國際市場和美國市場的持續增長勢頭,我們還有很長的路要走跑步。

  • And I'd be remiss if I didn't say how fast again that we're growing in both Crohn's right now and very exciting data in UC. And that market is very, very dynamic. So we feel very secure in our ability to continue to create a lot of value with Skyrizi.

    如果我不說我們現在在克羅恩病和加州大學非常令人興奮的數據方面的增長速度有多快,那我就失職了。這個市場非常非常有活力。因此,我們對繼續通過 Skyrizi 創造大量價值的能力感到非常放心。

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

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

  • This is Tom. Regarding the question on our triplet program, yes, we are -- our C2 corrector that we just tested did not work. This was not our first attempt that producing one and we do not have another backup. So we don't have other options than to discontinue the CF program.

    這是湯姆。關於我們的三元組程序的問題,是的,我們是——我們剛剛測試的 C2 校正器沒有工作。這不是我們第一次嘗試製作一個,我們沒有另一個備份。所以我們除了停止 CF 程序之外別無選擇。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Evan. Operator, next question, please.

    謝謝,埃文。接線員,請問下一個問題。

  • Operator

    Operator

  • Our next question comes from Trung Huynh with Credit Suisse.

    我們的下一個問題來自瑞士信貸的 Trung Huynh。

  • Carson Wong - Research Analyst

    Carson Wong - Research Analyst

  • This is Carson on for Trung. Just on Imbruvica, how confident are you for the [5.7] hem-onc guide given the significant competitive pressures there? I mean I understand Brukinsa did particularly have legs in the U.S. until late January. What level of pricing pressures can we expect through the year? And is there a potential for further step downs in your guide for later in the year? And if you do that, could the trough be pushed out given the delay with 951 as well?

    這是 Trung 的 Carson。就 Imbruvica 而言,鑑於那裡存在巨大的競爭壓力,您對 [5.7] hem-onc 指南有多大信心?我的意思是,我知道 Brukinsa 在 1 月下旬之前在美國特別有影響力。我們可以預期全年的定價壓力是什麼水平?今年晚些時候,您的指南是否有可能進一步下調?如果你這樣做,考慮到 951 的延遲,是否可以將低谷推出?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • Yes. It's Jeff. And I think we think that's a very good call. And just as a reminder, we're not seeing significant pricing pressure in the market. This is really two effects, which is one, the cumulative effect as we've highlighted over the suppressed market over time, which looks to be normalizing. Actually, for the first time in 3 years, we actually saw a positive growth in the market. So that's encouraging.

    是的。是傑夫。我認為我們認為這是一個非常好的決定。提醒一下,我們沒有看到市場上存在巨大的定價壓力。這實際上是兩種效應,一種是累積效應,正如我們強調的隨著時間的推移市場受到抑制,這看起來正在正常化。實際上,這是 3 年來我們第一次真正看到市場出現正增長。所以這是令人鼓舞的。

  • The big driver is the share -- is the new patient share, which has been under pressure, initially under pressure by Calquence certainly from our own Venclexta and then the recent Brukinsa launch. And so when we put all of that into the calculus, we think we've got it right and it's probably unlikely that we're going to see any significant step down that would put that in jeopardy.

    最大的驅動力是份額——是新的患者份額,它一直承受著壓力,最初是來自 Calquence 的壓力,當然來自我們自己的 Venclexta,然後是最近推出的 Brukinsa。因此,當我們將所有這些都放入微積分中時,我們認為我們已經做對了,而且我們可能不太可能看到任何重大的下降都會危及它。

  • Robert A. Michael - Vice Chairman & President

    Robert A. Michael - Vice Chairman & President

  • Carson, this is Rob. I'll answer your second question. So I wouldn't consider Imbruvica in 951 to be variables that would push the trough out. It's really more about how the overall year plays out, particularly the second half with U.S. Humira. So if U.S. Humira does better and we outperform in '23, then we could see the trough in '24. I think the important thing to keep in mind is regardless of when the trough occurs, we wouldn't expect earnings to fall below the [1074 ex-IPR&D]. That's really what I would focus on, and we don't consider Imbruvica in 951 delays to be variables that would push that trough.

    卡森,這是羅伯。我會回答你的第二個問題。因此,我不會將 951 年的 Imbruvica 視為將低谷推出的變量。這實際上更多地是關於全年的表現,尤其是下半年美國 Humira 的表現。因此,如果美國 Humira 表現更好並且我們在 23 年表現出色,那麼我們可以在 24 年看到低谷。我認為要記住的重要一點是,無論何時出現低谷,我們都不會預期收益會低於 [1074 ex-IPR&D]。這才是我真正要關注的,我們不認為 951 年 Imbruvica 的延遲是會推動那個低谷的變量。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Carson. We are cognizant of a number of peers reporting today. And so in the interest of time, we have one last question.

    謝謝,卡森。我們知道今天有許多同行報告。為了節省時間,我們還有最後一個問題。

  • Operator

    Operator

  • Our last question comes from Geoff Meacham with Bank of America.

    我們的最後一個問題來自美國銀行的 Geoff Meacham。

  • Unidentified Analyst

    Unidentified Analyst

  • This is [Susan] on for Geoff Meacham. We had a follow-up on Imbruvica. Do you guys expect any changes to outlook following MCL/MDL withdrawal? And then do you expect any read-through to follicular lymphoma from that withdrawal?

    這是 Geoff Meacham 的 [Susan]。我們對 Imbruvica 進行了跟進。你們預計在 MCL/MDL 退出後前景會發生什麼變化嗎?那麼您是否期望從該撤回中讀出濾泡性淋巴瘤?

  • Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

    Jeffrey Ryan Stewart - Executive VP & Chief Commercial Officer

  • It's Jeff. Thank you for the question. First, these are very small indications. So to give you some sense of the relative size for Imbruvica, MCL is about 4% of the value. MDL is really less than 1% or about 1%. So we don't anticipate that those withdrawals due to the fact that we didn't get the confirmatory studies to clear, we'll have a material impact. I think it's also important to note that many physicians will continue these patients on the medication. They won't be all switched, for example, or taken off and put on another product. That's the market intelligence. There's no requirement that they need to do that for the physicians. And so net-net, this is not a really material issue given the size of those indications. And I think Roopal will address your point on follicle.

    是傑夫。感謝你的提問。首先,這些都是非常小的跡象。因此,為了讓您了解 Imbruvica 的相對規模,MCL 約為價值的 4%。 MDL 實際上小於 1% 或大約 1%。因此,我們預計,由於我們沒有明確確認研究這一事實,這些提款不會產生重大影響。我認為同樣重要的是要注意許多醫生將繼續對這些患者進行藥物治療。例如,它們不會全部切換,或取下並換上另一種產品。這就是市場情報。沒有要求他們需要為醫生這樣做。因此,考慮到這些跡象的規模,這並不是一個真正的實質性問題。我認為 Roopal 會解決你關於卵泡的觀點。

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

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

  • Yes, I can talk about FL here for a minute. So a Phase III readout is expected later this year. It's not clear if the MCL outcomes would be reflected in what we see there. But what I would say about FL is our focus would be with epcoritamab, or dual engager, which we expect DLBCL actions here soon. And then we have programs and we're seeing very high levels of response in FL with epco either as monotherapy or in combination, which we'll see some data in those combos in DLBCL and FL at ASCO as well.

    是的,我可以在這裡談談 FL。因此,預計今年晚些時候將進行 III 期讀數。目前尚不清楚 MCL 結果是否會反映在我們在那裡看到的內容中。但關於 FL,我要說的是,我們的重點將放在 epcoritamab 或雙重接合器上,我們預計 DLBCL 很快就會採取行動。然後我們有程序,我們看到 FL 與 epco 作為單一療法或聯合療法的反應非常高,我們也會在 ASCO 的 DLBCL 和 FL 中看到這些組合的一些數據。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

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

    謝謝,[蘇珊]。今天的電話會議到此結束。如果您想收聽通話重播,請訪問我們的網站 investors.abbvie.com。再次感謝您加入我們。

  • Operator

    Operator

  • Thank you for your participation. Participants, you may disconnect at this time.

    感謝您的參與。參與者,此時您可以斷開連接。