艾伯維 (ABBV) 2025 Q1 法說會逐字稿

內容摘要

AbbVie 公佈​​第一季業績強勁,在各個治療領域均超乎預期。他們正在提高全年獲利預期,並在未來成長的計劃方面取得進展。該公司正在投資肥胖症等新領域,並已製定策略交易以實現長期成長。

AbbVie 已做好充分準備,將在未來八年繼續實現成長。他們正積極與華盛頓領導層就關鍵政策重點進行溝通,並密切關注 FDA 的互動和潛在的貿易政策變化。該公司對其產品和即將推出的產品的表現持樂觀態度,特別是在腫瘤學領域。

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

  • Welcome to the AbbVie first-quarter 2025 earnings conference call. (Operator instructions) As a reminder, this call is being recorded.

    歡迎參加 AbbVie 2025 年第一季財報電話會議。(操作員指示)提醒一下,此通話正在被錄音。

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

    現在我想介紹投資者關係資深副總裁 Shea 女士。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Good morning, and thanks for joining us. Also on the call with me today are Rob Michael, Chief Executive Officer; Jeff Stewart, Executive Vice President, Chief Commercial Officer; Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer; and Scott Reents, Executive Vice President, Chief Financial Officer.

    早安,感謝您加入我們。今天與我一起參加電話會議的還有執行長 Rob Michael;傑夫‧史都華 (Jeff Stewart),執行副總裁、商務長; Roopal Thakkar,研發執行副總裁、首席科學官;以及執行副總裁兼財務長 Scott Reents。

  • 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.

    在我們開始之前,我要指出的是,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。AbbVie 警告稱,這些前瞻性陳述受風險和不確定性的影響,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的美國證券交易委員會 (SEC) 文件中。

  • AbbVie undertakes no obligation to update these forward-looking statements, except as required by law. On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions.

    除非法律要求,否則 AbbVie 不承擔更新這些前瞻性聲明的義務。在今天的電話會議上,將採用非公認會計準則財務指標來幫助投資者了解 AbbVie 的業務表現。這些非公認會計準則 (non-GAAP) 財務指標與我們今天的收益報告和監管文件中的可比較 GAAP 財務指標相協調,可在我們的網站上找到。在我們準備好發言之後,我們將回答您的問題。

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

    因此,我將把電話轉給 Rob。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • Thank you, Liz. Good morning, everyone, and thank you for joining us. AbbVie is off to an excellent start to the year with first quarter results exceeding expectations across several of our therapeutic areas. We also continue to advance our promising internal pipeline and add external opportunities to further strengthen our business and long-term outlook.

    謝謝你,莉茲。大家早安,感謝大家的收看。艾伯維今年開局良好,第一季業績在多個治療領域均超乎預期。我們也將繼續推進我們有前景的內部管道,並增加外部機會,以進一步加強我們的業務和長期前景。

  • Turning to our first quarter performance. We delivered adjusted earnings per share of $2.46, which is $0.10 above our guidance midpoint. Total net revenues were more than $13.3 billion, nearly $550 million ahead of our expectations.

    談談我們第一季的表現。我們實現的調整後每股收益為 2.46 美元,比我們的指導中位數高出 0.10 美元。總淨收入超過 133 億美元,比我們的預期高出近 5.5 億美元。

  • I'm especially pleased with the performance of our ex-Humira platform, which delivered robust sales growth of more than 21%. Immunology, neuroscience, oncology and aesthetics are all performing at or above our expectations, and we are well positioned to exceed our previous peak revenue in just the second full year following the US Humira LOE.

    我對我們除 Humira 之外的平台的表現尤其滿意,其銷售額實現了超過 21% 的強勁增長。免疫學、神經科學、腫瘤學和美學方面的表現均達到或超出了我們的預期,我們有望在美國 Humira LOE 之後的第二個整年內超越之前的峰值收入。

  • Based on this strong performance, we are raising our full year adjusted earnings per share guidance by $0.10 and now expect adjusted EPS between $12.09 and $12.29. As you are aware, there is speculation that sectoral tariffs could be forthcoming, any related impact from these tariffs as well as other potential new or reciprocal tariffs, have not been contemplated in our guidance.

    基於這一強勁表現,我們將全年調整後每股收益預期上調 0.10 美元,目前預計調整後每股收益在 12.09 美元至 12.29 美元之間。如您所知,有人猜測行業關稅可能即將出台,但我們的指導意見並未考慮這些關稅以及其他潛在的新關稅或互惠關稅的任何相關影響。

  • To the extent there is an impact, we believe it would be in line with our peers, given that AbbVie has an extensive manufacturing presence in the United States, including API, biologics, toxins and small molecules. And over the next decade, we anticipate investing more than $10 billion of capital in the US to support our volume growth and our expansion into new areas such as obesity.

    如果產生影響,我們認為其影響程度將與我們的同行一致,因為 AbbVie 在美國擁有廣泛的製造業務,包括 API、生物製劑、毒素和小分子。未來十年,我們預計將在美國投資超過 100 億美元的資金,以支持我們的銷售成長和向肥胖症等新領域的擴張。

  • Turning back to our performance. I'm very pleased with the excellent progress we are making with several pipeline programs that have the potential to be meaningful sources of growth. These include lutikizumab across several immunology indications. 383 and multiple myeloma, and our next-generation ADCs, including Temab-A for several solid tumor types and 706 for small cell lung cancer. We also continue to add depth to our pipeline with strategic transactions that can help drive growth in the next decade.

    回到我們的表現。我很高興看到我們在多個管道項目上取得了出色的進展,這些項目有可能成為有意義的成長來源。其中包括針對多種免疫學適應症的魯替珠單抗。 383 和多發性骨髓瘤,以及我們的下一代 ADC,包括用於幾種實體腫瘤類型的 Temab-A 和用於小細胞肺癌的 706。我們也將繼續透過策略交易來擴大我們的管道深度,以幫助推動未來十年的成長。

  • This includes the recent acquisition of Nimble Therapeutics to expand our immunology portfolio with oral peptides, as well as the license agreement with Gubra to develop an amylin analog for the treatment of obesity. Obesity represents a significant global health concern with high unmet need.

    其中包括最近收購 Nimble Therapeutics,以透過口服勝肽擴展我們的免疫學產品組合,以及與 Gubra 達成協議,開髮用於治療肥胖症的胰淀素類似物。肥胖是全球重大的健康問題,並且存在大量未滿足的需求。

  • This market will continue to evolve with improved offerings. And we believe our program with Gubra has a potential to deliver a differentiated asset. Going forward, we plan to invest further in obesity, along with other opportunities across our existing five key growth areas.

    隨著產品的不斷改進,這個市場將繼續發展。我們相信,我們與 Gubra 的合作項目有潛力帶來差異化的資產。展望未來,我們計劃進一步投資肥胖症領域以及我們現有五個關鍵成長領域的其他機會。

  • In summary, the fundamentals of our business are strong, and we are well positioned for the long term. AbbVie has a clear runway to growth for at least the next eight years, including a high single-digit revenue CAGR through 2029.

    總而言之,我們的業務基礎強勁,並且我們已做好長期發展的準備。艾伯維在未來至少八年內擁有清晰的成長軌跡,包括到 2029 年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?

    接下來,我將把電話轉給傑夫,請他對我們的商業亮點發表更多評論。傑夫?

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Thank you, Rob. I'll start with the quarterly results for immunology, which delivered total revenues of more than $6.2 billion, exceeding our expectations. Skyrizi and Rinvoq are performing exceptionally well, contributing $5.1 billion in combined sales this quarter, reflecting growth of more than 65%. I'm especially encouraged with our portfolio performance across IBD, where Skyrizi and Rinvoq continue to capture significant share given their efficacy, safety and dosing profiles.

    謝謝你,羅布。我先介紹免疫學的季度業績,該部門的總收入超過 62 億美元,超出了我們的預期。Skyrizi 和 Rinvoq 表現非常出色,本季總銷售額達 51 億美元,增幅超過 65%。我對我們在 IBD 的投資組合表現感到特別鼓舞,其中 Skyrizi 和 Rinvoq 憑藉其功效、安全性和劑量特性繼續佔據重要份額。

  • In Crohn's disease, which is roughly two-third of the overall IBD market, these two treatments together are capturing roughly one out of every two in-play patients in the US and total prescription share is now in the mid-teens.

    克隆氏症約佔整個 IBD 市場的三分之二,這兩種治療方法加起來大約佔據了美國每兩名 IBD 患者中的一名,總處方份額目前已達到十幾歲。

  • Internationally, our Crohn's portfolio has achieved in-play leadership in nearly a dozen key countries. In ulcerative colitis, Skyrizi has already achieved the leading in play share in the US following the launch in the second half of last year. Skyrizi and Rinvoq together are now capturing one out of every three in-play UC patients. A very strong leadership position for AbbVie.

    在國際上,我們的克隆氏症產品組合已在近十幾個主要國家取得了領先地位。在潰瘍性結腸炎領域,Skyrizi 自去年下半年上市以來,已在美國佔據領先地位。目前,Skyrizi 和 Rinvoq 聯手治療的 UC 患者佔總患者的三分之一。艾伯維 (AbbVie) 的領導地位非常強大。

  • We are also seeing strong momentum across indications in dermatology and rheumatology as well. For Skyrizi, we continue to gain share in Psoriatic disease, where we have achieved the leading in-play share of new and switching patients in nearly 30 countries and see substantial room for total share growth.

    我們也看到皮膚病學和風濕病學領域出現強勁發展勢頭。對於 Skyrizi,我們在銀屑病領域的份額持續增長,我們在近 30 個國家/地區的新患者和轉換患者中取得了領先的份額,並且看到了總份額的巨大增長空間。

  • For Rinvoq, we are seeing increasing prescription demand globally across each of the room indications, as well as additional momentum in atopic dermatitis, the fastest-growing immunology market where we have two compelling head-to-head studies versus (technical difficulty). We are also preparing for the global launch of giant cell arteritis, another new source of growth for Rinvoq.

    對於 Rinvoq,我們看到全球範圍內針對各個適應症的處方需求都在不斷增長,並且在異位性皮膚炎領域也呈現出了額外的增長勢頭,這是增長最快的免疫學市場,我們在該市場進行了兩項引人注目的頭對頭研究,(技術難度)。我們也正在為鉅細胞動脈炎的全球上市做準備,這是 Rinvoq 的另一個新的成長源。

  • We received European approval earlier this month and expect FDA approval soon. The addition of this indication further rounds out Rinvoq's rheumatology label and gives patients with GCA access to a new compelling oral therapeutic option. Overall, Skyrizi and Rinvoq are demonstrating impressive results across all of their approved indications, and we will be raising our full year sales guidance for both products.

    我們本月初獲得了歐洲的批准,預計很快就會獲得 FDA 的批准。此適應症的加入進一步完善了 Rinvoq 的風濕病學標籤,並為 GCA 患者提供了一種新的引人注目的口服治療選擇。總體而言,Skyrizi 和 Rinvoq 在所有核准適應症中均表現出令人印象深刻的結果,我們將提高這兩種產品的全年銷售預期。

  • Turning now to Humira, which delivered global sales of $1.1 billion, down 49.5% on an operational basis, below our expectations, primarily due to faster share erosion from biosimilar competition as well as as well as further molecule compression in the US. As a result, we will be lowering our full year sales guidance for US Humera.

    現在來看看 Humira,其全球銷售額為 11 億美元,按營運基礎計算下降了 49.5%,低於我們的預期,這主要是由於生物仿製藥競爭導致的市場份額更快侵蝕以及美國分子進一步壓縮。因此,我們將下調美國 Humera 的全年銷售預期。

  • Moving to oncology, where total revenues were $1.6 billion exceeding our expectations. In Bruvica Global sales were $738 million down 11.9%, reflecting competitive dynamics in CLL. Then collects the global revenues were $665 million, up 12.3% on an operational basis.

    轉向腫瘤學,總收入達到 16 億美元,超出了我們的預期。Bruvica Global 的銷售額為 7.38 億美元,下降 11.9%,反映了 CLL 領域的競爭動態。全球營業收入為 6.65 億美元,較去年同期成長 12.3%。

  • This strong performance reflects continued momentum in CLL, as well as shared leadership in frontline AML among patients who are ineligible for intensive induction chemotherapy. We also have an emerging commercial portfolio in solid tumors.

    這一強勁表現反映了 CLL 領域的持續發展勢頭,以及在不適合接受強化誘導化療的患者中,在一線 AML 領域的共同領導地位。我們在實體腫瘤領域也擁有新興的商業產品組合。

  • This includes Elahere here, our leading ADC for ovarian cancer with global sales of $179 million, as well as (technical difficulty) COV, a potential new medicine for late-line non-small cell lung cancer patients with US regulatory approval and commercialization expected in the next couple of months.

    其中包括 Elahere,這是我們治療卵巢癌的領先 ADC,全球銷售額達 1.79 億美元,以及(技術難度)COV,這是一種針對晚期非小細胞肺癌患者的潛在新藥,預計在未來幾個月內獲得美國監管部門的批准並實現商業化。

  • (inaudible) will be supported by a dedicated sales force and medical affairs team which will target academic and community cancer treatment centers to reinforce the importance of CMET as a biomarker and build relationships that support our emerging solid tumor franchise.

    (聽不清楚)將得到專門的銷售團隊和醫療事務團隊的支持,該團隊將針對學術和社區癌症治療中心,以加強 CMET 作為生物標誌物的重要性,並建立支持我們新興實體瘤特許經營的關係。

  • Turning now to aesthetics, which delivered global sales of $1.1 billion down 10.2% on an operational basis. This was in line with our expectations. Botox cosmetic global revenues were $556 million down 10.7% on an operational basis, and Juvederm sales were $231 million, down 20% on an operational basis.

    現在談談美學,其全球銷售額為 11 億美元,按營運基礎計算下降了 10.2%。這符合我們的預期。保妥適化妝品全球營收為 5.56 億美元,營運下降 10.7%,而 Juvederm 銷售額為 2.31 億美元,營運下降 20%。

  • As we have seen over the last several quarters, economic headwinds have continued to impact market conditions. Based on the trends we are seeing, including a decline in recent consumer sentiment, we are moderating our assumptions for category growth globally and adjusting our full year sales guidance for aesthetics accordingly.

    正如我們在過去幾季所看到的那樣,經濟逆風持續影響著市場狀況。根據我們看到的趨勢,包括近期消費者情緒的下降,我們正在調整對全球類別成長的假設,並相應地調整我們對美學的全年銷售指導。

  • While near term aesthetics market conditions remain challenging, the long term prospects for the category remain attractive, given high consumer interest and low penetration rates for facial injectables. I'm particularly excited about BoNT/E, our fast acting short duration toxin which we recently submitted for US regulatory review.

    儘管短期美容市場狀況仍然充滿挑戰,但鑑於消費者興趣高漲且臉部注射滲透率低,該類別的長期前景仍然具有吸引力。我對 BoNT/E 感到特別興奮,這是我們最近提交給美國監管機構審查的速效短效毒素。

  • This first in class toxin represents a distinctive innovation for the treatment of glabellar lines and has the potential to be an important catalyst for new patient activation into the facial aesthetics category. We anticipate commercialization next year.

    這種首創的毒素代表了治療眉間紋的獨特創新,並有可能成為吸引新患者進入臉部美學領域的重要催化劑。我們預計明年將實現商業化。

  • Moving now to neuroscience, where total revenues were approximately $2.3 billion, up 17% on an operational basis, with all key products exceeding our expectations. Raylar Global sales were $765 million up 10.3%, reflecting share capture in both bipolar 1 disorder and adjunctive major depression. We continue to get very positive feedback on Raylar's profile in terms of dosing flexibility, low sedation, and the ability to treat a full spectrum of symptoms.

    現在轉向神經科學,總收入約為 23 億美元,營運成長 17%,所有主要產品均超出我們的預期。Raylar 全球銷售額達 7.65 億美元,成長 10.3%,反映出其在 1 型雙相情感障礙和輔助性重度憂鬱症領域的市場份額。我們不斷收到關於 Raylar 在劑量靈活性、低鎮靜作用以及治療各種症狀的能力方面的非常積極的反饋。

  • We are very competitively positioned with our migraine portfolio where all three of our therapies continue to deliver double-digit operational growth. Botox therapeutic global revenues were $866 million up 17%. Ubrelvy Global sales were $240 million up 18%, and Qulipta Global revenues were $193 million up 48.3%.

    我們的偏頭痛產品組合極具競爭力,我們的三種療法均持續實現兩位數的營運成長。肉毒桿菌治療全球收入為 8.66 億美元,成長 17%。Ubrelvy 全球銷售額為 2.4 億美元,成長 18%,Qulipta 全球營收為 1.93 億美元,成長 48.3%。

  • And in Parkinson's disease, Violev global sales were $63 million reflecting continued strong uptake in Japan and Europe. We are also pleased with the early launch feedback in the US, where revenues are expected to ramp gradually over the next couple of quarters as we work to establish the appropriate medicare coverage and benefit determination.

    在帕金森氏症領域,Violev 的全球銷售額為 6,300 萬美元,反映出日本和歐洲市場持續強勁成長。我們也對美國早期推出的回饋感到滿意,隨著我們努力建立適當的醫療保險覆蓋範圍和福利確定,預計未來幾季的收入將逐步增加。

  • Lastly, we are making excellent progress with the development of Tavapodon in Parkinson's disease. This first in class D1D5 selective dopamine agonist has a favorable benefit risk profile and the potential to differentiate in several areas such as sedation and impulse control.

    最後,我們在帕金森氏症藥物Tavapodon的研發方面取得了巨大進展。這種首創的 D1D5 選擇性多巴胺激動劑具有良好的效益風險特徵,並有可能在鎮靜和衝動控制等多個領域實現差異化。

  • Tavapodon could potentially be used as a monotherapy for early Parkinson's disease, as well as an adjunctive therapy to Levodopa for more advanced patients, which would be a complementary addition to our existing PD portfolio with Violev and DOA. We expect to submit to Tavapodon for regulatory review later this year, with commercialization expected in 2026. Overall, I'm extremely pleased with the execution and strong momentum across our commercial portfolio.

    Tavapodon 有可能被用作早期帕金森氏症的單一療法,以及針對較晚期患者的左旋多巴的輔助療法,這將對我們現有的 Violev 和 DOA PD 產品組合形成補充。我們預計今年稍後向 Tavapodon 提交監管審查,並預計於 2026 年實現商業化。總體而言,我對我們的商業投資組合的執行情況和強勁勢頭感到非常滿意。

  • And with that, I'll turn the call over to Roopal for comments on our R&D highlights. Roopal.

    接下來,我將把電話轉給 Roopal,請他們對我們的研發亮點發表評論。羅帕爾。

  • Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

    Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

  • Thank you, Jeff. I will start with immunology. We received European approval for Rinvoq in GCA and expect FDA approval soon. We remain on track for several important data readouts this year as well, including Phase 3 data for Rinvoq and Alopecia areata and Vitiligo and data from Skyrizi's head-to-head study in psoriasis versus (inaudible)

    謝謝你,傑夫。我將從免疫學開始。我們已獲得歐洲對 Rinvoq 在 GCA 治療方面的批准,並預計很快將獲得 FDA 批准。今年我們仍將繼續發布幾項重要的數據,包括 Rinvoq 和斑禿及白斑的 3 期數據,以及 Skyrizi 在銀屑病與(聽不清楚)

  • Our early and mid-stage immunology pipeline continues to advance. Recent initiations include, a Phase 2 study evaluating Skyrizi in combination with Vedolizumabin psoriatic arthritis. And a Phase 1 study for our next-generation TL1A antibody which is designed to have less frequent dosing compared to other TL1A's in development and will be evaluated in combination with Skyrizi in both Crohn's disease and ulcerative colitis.

    我們的早期和中期免疫學管道繼續推進。最近啟動的一項 2 期研究評估 Skyrizi 與 Vedolizumabin 聯合治療乾癬性關節炎的療效。我們的下一代 TL1A 抗體正在進行第一階段研究,與正在開發的其​​他 TL1A 相比,該抗體的給藥頻率較低,並將與 Skyrizi 聯合用於治療克羅恩病和潰瘍性結腸炎。

  • This summer, we will start a Phase 2 study evaluating a combination of lutukizumab and our anti-CD40 Ravagalimab in rheumatoid arthritis. Moving to our ADCs and oncology. We anticipate accelerated approval in the second quarter for Teliso-V as a monotherapy in previously treated nonsquamous non-small cell lung cancer with high c-Met expression.

    今年夏天,我們將啟動一項 2 期研究,評估魯妥珠單抗和抗 CD40 Ravagalimab 聯合治療類風濕性關節炎的效果。轉向我們的 ADC 和腫瘤學。我們預計 Teliso-V 將在第二季度獲得加速批准,作為治療先前接受過治療且 c-Met 表達較高的非鱗狀非小細胞肺癌的單一療法。

  • This is a segment of lung cancer with high unmet need, and when approved, Teliso-V will be the first c-Met directed ADC for these patients. We're also making good progress with Tmab-A, our next-generation c-Met ADC.

    這是肺癌領域中未滿足需求較高的領域,一旦獲得批准,Teliso-V 將成為該類患者首個針對 c-Met 的 ADC。我們的下一代 c-Met ADC Tmab-A 也取得了良好進展。

  • A Phase 2 dose optimization study evaluating Tmab-A with a PD-1 inhibitor as a frontline combination therapy in EGFR wild-type non-small cell lung cancer was recently initiated. In the EGFR mutant segment, we plan to initiate studies for Tmab-A as a monotherapy in the second-line setting and in combination with osimertinib in the first-line setting.

    最近啟動了一項 2 期劑量優化研究,評估 Tmab-A 與 PD-1 抑制劑作為 EGFR 野生型非小細胞肺癌一線聯合療法。在 EGFR 突變部分,我們計劃啟動 Tmab-A 作為二線單一療法以及一線與奧希替尼聯合療法的研究。

  • Preliminary Phase 1 results will be presented at the upcoming ASCO meeting. This year, Phase 2 data from our CRC study evaluating Tmab-A in combination with bevacizumab will be available, which could enable a Phase 3 study in an all comers population. Progress also continues with ABBV 706 in small cell lung cancer.

    第一階段的初步結果將在即將召開的 ASCO 會議上公佈。今年,我們將獲得評估 Tmab-A 與貝伐單抗聯合治療的 CRC 研究的第 2 階段數據,這可以為針對所有人群的第 3 階段研究提供支持。ABBV 706 在小細胞肺癌治療中也持續取得進展。

  • Recall this ADC utilizes the same topo warhead and linker technology as Tmab-A, but with an antibody that targets says (inaudible) In the Phase 1 study, 706 was efficacious across doses with an objective response rate of approximately 60% in patients with relapsed or refractory small cell lung cancer.

    回想一下,這種 ADC 採用與 Tmab-A 相同的拓樸彈頭和連接技術,但帶有一種標靶抗體(聽不清楚)在第 1 期研究中,706 在各個劑量下均有效,在復發或難治性小細胞肺癌患者中的客觀反應率約為 60%。

  • Based on maturing duration of response, and progression-free survival data, we plan to advance 706 into a trial in a relapsed/refractory population, and a dose optimization study, in combination with a PD-L1 in the front line, with the goal of establishing a chemo-sparing regimen as a new standard of care.

    根據成熟的反應持續時間和無惡化存活期數據,我們計劃將 706 推進到復發/難治性人群的試驗和劑量優化研究,結合一線 PD-L1,目標是建立化療節約方案作為新的護理標準。

  • In the area of hematologic oncology, the data readout remains on track for the Phase 3 Venclexta MDS trial. And if positive, our regulatory submissions would follow later in the year. The regulatory submission for PVC in BPDCN is also planned for this year.

    在血液腫瘤學領域,第 3 階段 Venclexta MDS 試驗的數據讀取仍在按計劃進行。如果結果呈陽性,我們將在今年稍後向監管部門提交申請。BPDCN 也計劃於今年提交 PVC 的監管申請。

  • We continue to make good progress with our BCMA CD3 bispecific ABBV 383 in multiple myeloma. Recruitment is going well in the Phase 3 monotherapy study in later lines, and we are on track to be fully enrolled by early next year.

    我們的 BCMA CD3 雙特異性 ABBV 383 在治療多發性骨髓瘤方面持續取得良好進展。後期的 3 期單一療法研究的招募工作進展順利,我們預計在明年年初完成全部招募。

  • Additionally, we continue to evaluate 383 in various companies, including with pomalift, Revlimid, (inaudible) and Iberdomide. We'll begin seeing data from these combinations next year, which could enable Phase 3 studies in earlier lines of therapy. Now moving to neuroscience. Term data from the long-term Tempo Phase 3 study, we continue to support tavapadon's favorable benefit risk profile.

    此外,我們繼續評估各公司的 383,包括 pomalift、Revlimid、(聽不清楚)和 Iberdomide。我們將於明年開始看到這些組合的數據,這可能有助於進行早期治療的 3 期研究。現在轉向神經科學。根據長期 Tempo 第 3 階段研究的長期數據,我們繼續支持 tavapadon 良好的效益風險狀況。

  • Efficacy in both early and advanced Parkinson's patients was maintained beyond a year and the safety profile was consistent with that observed in the previous Phase 3 studies, with no new safety concerns identified. Rates of adverse events of special interest remained low, with impulse control disorders and peripheral edema, less than 1%.

    對早期和晚期帕金森氏症患者的療效可維持一年以上,其安全性與先前的 3 期研究觀察到的一致,沒有發現新的安全性問題。特別值得關注的不良事件發生率仍然很低,其中衝動控制障礙和周邊水腫發生率不到 1%。

  • Dyskinesia approximately 2% and sedation less than 5%. These results underscore tavapadon's potential to become an important new treatment option for patients with Parkinson's disease. Our regulatory application is planned earlier in the year.

    運動障礙約佔 2%,鎮靜少於 5%。這些結果強調了 tavapadon 成為帕金森氏症患者重要新治療選擇的潛力。我們的監管申請計劃在今年稍早提出。

  • Moving to other areas of our pipeline. In aesthetics, the regulatory application for a rapid onset, short-acting toxin BoNT/E was recently submitted. We also began the clinical program to evaluate co-administration of BoNT/E and Botox which has the potential to be co-formulated as a novel product, offering the combined benefits of rapid onset and Botox-like duration.

    轉移到我們管道的其他區域。在美學領域,最近提交了快速起效、短效毒素 BoNT/E 的監管申請。我們還啟動了臨床項目,評估 BoNT/E 和 Botox 的聯合使用,這有可能共同配製為一種新產品,提供快速起效和類似 Botox 的持續時間的綜合優勢。

  • In obesity, our partner, Gubra recently announced positive interim results from the first part of a multiple ascending dose study for our long-acting amylin analog, ABBV 295. This initial phase of the study tested 1 and 2 milligrams, dosed once weekly for six weeks in healthy lean and overweight patients.

    在肥胖症領域,我們的合作夥伴 Gubra 最近宣布了我們的長效胰淀素類似物 ABBV 295 的多次遞增劑量研究的第一部分取得了積極的中期結果。研究的初始階段對健康瘦弱和超重患者進行了 1 毫克和 2 毫克的測試,每週服用一次,持續六週。

  • The study showed 295 performed well, demonstrating a dose-dependent mean weight loss compared to placebo, and a tolerability profile consistent with the results from the single ascending dose study. Mean weight loss in the 2-milligram cohort which had a mean BMI of 24 was 7.8%, compared to a weight gain of 2% in the placebo arm on day 43.

    研究表明,295 表現良好,與安慰劑相比表現出劑量依賴性平均體重減輕,且耐受性特徵與單次遞增劑量研究的結果一致。服用 2 毫克且平均 BMI 為 24 的組別的平均體重減輕了 7.8%,而服用安慰劑的組別在第 43 天的體重增加了 2%。

  • The second phase of this study is ongoing and is evaluating higher doses in overweight and obese patients with 12-week dosing. Titration and longer dosing intervals will also be assessed. Full data from this part of the study are expected next year. To summarize, significant progress continues with our pipeline, and we look forward to important data readouts with regulatory submissions and approvals throughout 2025.

    這項研究的第二階段正在進行中,正在評估超重和肥胖患者 12 週的較高劑量治療效果。還將評估滴定和更長的給藥間隔。預計明年將公佈該部分研究的全部數據。總而言之,我們的產品線繼續取得重大進展,我們期待在 2025 年全年獲得監管提交和批准的重要數據。

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

    說完這些,我會把電話轉給史考特。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • Thank you, Roopal. Starting with our first quarter results. We reported adjusted earnings per share of $2.46, which is $0.10 above our guidance midpoint. These results include a $0.13 unfavorable impact from acquired IP R&D expense. Total net revenues were more than $13.3 billion, reflecting robust growth of 9.8% on an operational basis, excluding a 1.4% unfavorable impact from foreign exchange.

    謝謝你,Roopal。從我們的第一季業績開始。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。這些結果包括因收購 IP 研發費用而產生的 0.13 美元不利影響。總淨收入超過 133 億美元,反映出營運基礎上 9.8% 的強勁成長,不包括 1.4% 的外匯不利影響。

  • Adjusted gross margin was 84.1% of sales. Adjusted R&D expense was 15.4% of sales, and adjusted SG&A expense was 24.6% of sales. The adjusted operating margin ratio was 42.3% of sales, which includes a 1.9% unfavorable impact from acquired IP R&D expense. Net interest expense was $627 million. The adjusted tax rate was 14.2%.

    調整後的毛利率為銷售額的84.1%。調整後的研發費用佔銷售額的 15.4%,調整後的銷售、一般及行政費用佔銷售額的 24.6%。調整後的營業利益率為銷售額的42.3%,其中包括收購智慧財產權研發費用帶來的1.9%的不利影響。淨利息支出為 6.27 億美元。調整後的稅率為14.2%。

  • Turning to our financial outlook. We are raising our full year adjusted earnings per share guidance to between $12.09 and $12.29. Please 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 $59.7 billion, an increase of $700 million. This reflects an estimated 0.6% unfavorable impact from foreign exchange on full year sales growth.

    談談我們的財務前景。我們將全年調整後每股盈餘預期上調至 12.09 美元至 12.29 美元之間。請注意,本指南不包括可能在第一季之後產生的收購智慧財產權與開發費用的估計。我們現在預計總淨收入約為 597 億美元,增加 7 億美元。這反映出外匯對全年銷售成長預計產生 0.6% 的不利影響。

  • This updated revenue forecast includes the following approximate assumptions for several of our key products. We now expect Skyrizi global revenues of $16.5 billion, an increase of $600 million, reflecting share gains in psoriasis and IBD.

    此更新的收入預測包括我們幾種主要產品的以下近似假設。我們現在預計 Skyrizi 的全球收入將達到 165 億美元,增加 6 億美元,這反映了牛皮癬和 IBD 市場的份額成長。

  • Rinvoq global sales of $8.2 billion, an increase of $300 million, reflecting momentum across all approved indications. US Humira revenues of $3.5 billion, a decrease of $500 million, reflecting higher erosion from biosimilar competition as well as further molecule compression.

    Rinvoq 全球銷售額為 82 億美元,成長 3 億美元,反映出所有核准適應症的強勁成長動能。美國 Humira 的營收為 35 億美元,減少了 5 億美元,反映出生物相似藥競爭的加劇以及分子進一步壓縮。

  • Botox Therapeutic global sales of $3.6 billion, an increase of $100 million, reflecting growth in chronic migraine and other indications. Total oral CGRP revenues of $2.2 billion, an increase of $100 million, reflecting strong prescription demand. Imbruvica global revenues of $2.8 billion, an increase of $100 million, reflecting lower erosion.

    肉毒桿菌治療全球銷售額為 36 億美元,增加了 1 億美元,反映了慢性偏頭痛和其他適應症的成長。口服 CGRP 總收入為 22 億美元,增加了 1 億美元,反映出強勁的處方需求。Imbruvica 全球營收為 28 億美元,增加 1 億美元,反映侵蝕減少。

  • Venclexta global sales of $2.7 billion, an increase of $100 million, reflecting continued uptake in both CLL and AML across our key countries. And for aesthetics, we now expect global sales of $5.1 billion as we are moderating our assumptions for market growth globally. As a result, total sales guidance for Botox and Juvederm will each be lower by roughly $100 million.

    Venclexta 全球銷售額為 27 億美元,增加了 1 億美元,反映了我們主要國家對 CLL 和 AML 的持續吸收。對於美學方面,我們現在預計全球銷售額為 51 億美元,因為我們正在調整對全球市場成長的假設。因此,Botox 和 Juvederm 的總銷售額預期將分別下降約 1 億美元。

  • Moving to the P&L for 2025. We continue to forecast full year adjusted gross margin of approximately 84% of sales, and adjusted SG&A expense of approximately $13.2 billion. We now expect adjusted R&D expense of approximately $8.9 billion, reflecting additional investment in our robust pipeline for long-term growth. We also now anticipate an adjusted operating margin ratio of roughly 46.5% of sales, in line with our previous expectations, after including the 0.4% and an unfavorable impact of acquired IPR&D expense incurred through the first quarter.

    轉到 2025 年的損益表。我們持續預測全年調整後毛利率約為銷售額的 84%,調整後的銷售、一般及行政費用約為 132 億美元。我們現在預計調整後的研發費用約為 89 億美元,這反映了我們為實現長期成長而進行的強大研發管線的額外投資。我們也預計,調整後的營業利潤率約為銷售額的 46.5%,與我們先前預期的一致,其中計入了 0.4% 的不利影響以及第一季產生的收購智慧財產權與開發費用。

  • Turning to the second quarter. We anticipate net revenues of approximately $15 billion. This reflects an estimated 0.3% unfavorable impact from foreign exchange on full year sales growth. We are forecasting an adjusted operating margin ratio of roughly 49.5%. We expect adjusted earnings per share between $3.26 and $3.30.

    轉向第二季。我們預計淨收入約為 150 億美元。這反映出外匯對全年銷售成長約 0.3% 的不利影響。我們預測調整後的營業利益率約為 49.5%。我們預計調整後的每股盈餘將在 3.26 美元至 3.30 美元之間。

  • This guidance does not include acquired IPR&D expense that may be incurred in the quarter. Our guidance is based on current trade rules and does not reflect the impact of any additional trade policy shifts, including pharmaceutical sector tariffs.

    本指引不包括本季可能產生的已收購知識產權與開發費用。我們的指導是基於當前的貿易規則,並不反映任何額外貿易政策變化的影響,包括製藥業關稅。

  • While it's difficult to quantify in the absence of actual policy details, it's worth noting, any related unfavorability in 2025 would reflect a partial year given the time line for a 232 investigation. We are actively preparing for a number of potential scenarios and would expect to put into place mitigation strategies as we have more information. Relevant to these dynamics, I would also highlight that AbbVie has a significant US manufacturing presence that spans 11 sites with plans to add four new manufacturing plants to our network, expanding our production for API, drug product, peptides and devices in the United States.

    雖然在缺乏實際政策細節的情況下很難量化,但值得注意的是,考慮到 232 調查的時間線,2025 年的任何相關不利因素都只能反映一年中的部分時間。我們正在積極為多種潛在情況做準備,並希望在獲得更多資訊後製定緩解策略。與這些動態相關,我還要強調的是,AbbVie 在美國擁有重要的製造業務,遍及 11 個地點,並計劃在我們的網路中增加四個新的製造工廠,擴大我們在美國 API、藥品、勝肽和設備的生產。

  • As we continue to invest and grow our US operational footprint, we believe a more competitive tax policy, building on what was accomplished through 2017 tax reform will incur a sustainable shift towards US manufacturing over the long term. In closing, I'm very pleased with the excellent start to the year. We are demonstrating strong momentum across the portfolio and continue to be well positioned to deliver robust growth in 2025 and beyond.

    隨著我們繼續投資並擴大美國業務,我們相信,在 2017 年稅制改革的基礎上,更具競爭力的稅收政策將長期持續地推動製造業轉移到美國。最後,我對今年的好開始感到非常高興。我們的整個投資組合都展現出強勁的發展勢頭,並將繼續保持有利地位,在 2025 年及以後實現強勁增長。

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

    說完這些,我就把電話轉回給 Liz。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝,斯科特。我們現在開始提問。為了在通話的剩餘時間裡盡可能多地聽取意見,我們要求您將問題限制為一兩個。接線員,請問第一個問題。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    摩根大通的克里斯·肖特。

  • Chris Schott - Analyst

    Chris Schott - Analyst

  • Great. Thanks for the question and congrats on the results. Just two for me. Maybe first on Skyrizi and Rinvoq. Obviously, some big step-up in the guidance here. Can you just elaborate a little bit more on which of the indications are most attributable to the upside we're seeing right now? And maybe just talk a little bit about the competitive landscape, maybe particularly Tremfya more broadly launching in IBD and how you're thinking about that dynamic?

    偉大的。感謝您的提問,並祝賀取得的成果。對我來說只要兩個。也許首先是 Skyrizi 和 Rinvoq。顯然,這裡的指導已經有了很大的進步。您能否更詳細地說明哪些跡象最能歸因於我們目前看到的上行趨勢?也許您可以稍微談談競爭格局,特別是 Tremfya 在 IBD 中更廣泛地推出的情況,以及您如何看待這種動態?

  • And then just my second question was on (inaudible) immunology on Humira. Can you just talk a bit more about how you're thinking about the tail for Humira in light of some of the erosion that you're seeing this year? Thanks so much.

    我的第二個問題是關於 Humira 的免疫學(聽不清楚)。有鑑於今年您看到的一些下滑趨勢,您能否再多談談您對 Humira 未來前景的看法?非常感謝。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • Chris, this is Scott. I'll start with kind of where we saw the increase attribute to for the various indications, and I'll turn it to Jeff for your other questions. So we raised Skyrizi by $600 million to $16.5 billion, and that's split between $200 million in psoriatic and $400 million in IBD indications.

    克里斯,這是斯科特。我將從我們看到的各種跡象表明屬性增加的地方開始,然後我會把問題交給傑夫回答你的其他問題。因此,我們將 Skyrizi 的銷售額提高了 6 億美元,達到 165 億美元,其中 2 億美元用於治療乾癬,4 億美元用於治療 IBD 疾病。

  • And then with respect to Rinvoq, we raised that $300 million, and that's across all of the approved indications. So you can attribute that to $100 million for rheumatology $100 million for derm and the remaining $100 million for IBD.

    關於 Rinvoq,我們籌集了 3 億美元,涵蓋了所有核准的適應症。因此,你可以將其歸因於 1 億美元用於風濕病學、1 億美元用於皮膚病學以及剩餘的 1 億美元用於 IBD。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yes. Thanks, Chris. It's Jeff. And maybe I'll give some sense. We're obviously very, very pleased with the performance of Skyrizi and Rinvoq in immunology, as you've seen from the report. Maybe to give some perspective, it's not uncommon to start to see in-class competition. We've seen that in psoriasis. We've seen that across the board.

    是的。謝謝,克里斯。是傑夫。也許我會給一些解釋。正如您從報告中看到的,我們顯然對 Skyrizi 和 Rinvoq 在免疫學方面的表現非常滿意。也許從某個角度來看,開始看到課堂競爭並不罕見。我們在牛皮癬中看到過這種情況。我們已經全面看到了這一點。

  • And maybe I'll just give a little bit of a perspective over sort of the historical dynamics that we've seen with the IL-23 category. So for example, if you go back to like 2018, 2019, when the IL-23s were starting to come in psoriasis, the total patient share at that time in the early days was about 7% of the IL-23 class.

    也許我可以稍微介紹一下我們在 IL-23 類別中看到的歷史動態。例如,如果回顧 2018 年、2019 年,當 IL-23 開始用於治療牛皮癬時,當時早期患者總數約為 IL-23 類的 7%。

  • Now it's over [60]. And if we look at where IBD is, obviously, we launched first with Skyrizi in Crohn's and everything is recently launching here in UC, it's about 7% of the total patient share in IBD. So you can imagine as we start to watch what this category is going to mean to transform IBD, we remain very confident.

    現在一切都結束了[60]。如果我們看看 IBD 的情況,顯然,我們首先在克羅恩病中推出了 Skyrizi,並且最近在 UC 中也推出了其他藥物,它約佔 IBD 總患者份額的 7%。因此,你可以想像,當我們開始觀察這個類別對於轉變 IBD 意味著什麼時,我們仍然非常有信心。

  • It's not a zero-sum game. We feel very confident in our profile and what we're able to deliver if we look across UC, if we look across our head-to-head data versus sequence, versus the other trials. And so net-net, we see very, very strong momentum across the board regardless of competitors that may come in.

    這不是一場零和遊戲。如果我們縱觀 UC,如果我們縱觀我們的頭對頭資料與序列,以及其他試驗,我們對我們的概況和我們能夠提供什麼感到非常有信心。因此,總體而言,無論競爭對手如何,我們都看到了非常強勁的發展勢頭。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • And then my thoughts on the Humira tail, again, as I highlighted and Scott highlighted in his remarks, we are seeing a bit of faster erosions as the biosimilar start to play out. And this is, of course, the third year of the biosimilar event.

    然後我對 Humira 尾部的想法是,正如我和 Scott 在他的評論中所強調的那樣,隨著生物相似藥開始發揮作用,我們看到了更快的侵蝕。當然,這是生物相似藥活動舉辦的第三年。

  • So it's really not too surprising. We also do continue to see the molecule continue to erode. So as we look -- and we don't have full visibility, and we'll be monitoring the '26 access as we go throughout the year, we do expect it to step down again.

    所以其實不太令人驚訝。我們也確實看到分子繼續受到侵蝕。因此,當我們觀察時——雖然我們沒有完全的了解,但我們將全年監控 26 個訪問權限,我們確實預計它會再次下降。

  • It just makes sense. That will be the fourth full year. So we'll have deeper visibility of that tail sometime over the course of the year. But as we said before, the real impact of the tail is when Humira does not have a meaningful headwind to our overall growth as a corporation. So we expect that to start to develop over that '26 time period.

    這很有道理。這將是第四個完整的年。因此,我們將在今年的某個時候對這個尾巴有更深入的了解。但正如我們之前所說,尾部的真正影響是當 Humira 對我們作為一家公司的整體成長沒有造成重大阻力時。因此我們預計這種情況將在 26 年期間開始發展。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Okay. Thank you, Scott. Operator, thank you, Chris, operator, next question, please.

    好的。謝謝你,斯科特。接線員,謝謝,接線員克里斯,請問下一個問題。

  • Operator

    Operator

  • Terrence Flynn, Morgan Stanley.

    摩根士丹利的特倫斯弗林。

  • Terrence Flynn - Analyst

    Terrence Flynn - Analyst

  • Great, thanks so much. Congrats on the quarter. And maybe two questions for me as well. You alluded to some of the mitigation strategies you're taking with respect to tariffs potentially. Could you just elaborate a little bit more there in terms of what that means for maybe inventory and then any contemplation on any changes to IP domiciling?

    太好了,非常感謝。恭喜本季取得佳績。對我來說也許還有兩個問題。您提到了您可能針對關稅採取的一些緩解策略。您能否更詳細地闡述這對庫存意味著什麼,以及對 IP 註冊地發生的任何變化有何考慮?

  • And the second question I had is on the your Amylin program there. I know you talked a little bit about next steps, but I was just wondering if you can elaborate in terms of how much higher you're going on doses, what you'd expect that to translate to in efficacy and maybe the size of those cohorts? Like how many more patients will we get in the next update? Thank you.

    我的第二個問題是關於你們的 Amylin 計劃。我知道您談到了下一步措施,但我只是想知道您是否可以詳細說明您將要增加多少劑量,您預計這會轉化為什麼樣的療效,以及這些群體的規模?例如,下次更新時我們會新增多少患者?謝謝。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • Thanks, Terence. This is Rob. So Scott and I will handle your first question. Then Roopal will handle your second question. So just to, I think, back up and maybe talk about AbbVie's manufacturing network and then what I can mention how we're thinking about potential mitigation.

    謝謝,特倫斯。這是羅布。因此,斯科特和我將處理您的第一個問題。然後 Roopal 將處理您的第二個問題。因此,我認為,回顧一下,也許可以談談 AbbVie 的製造網絡,然後我可以提一下我們如何考慮潛在的緩解措施。

  • I think it's important to know that we have a broad footprint that allows us to ensure supply for our patients around the world. And that's really why you've been able to see us avoid supply disruptions during events like the COVID pandemic.

    我認為重要的是要知道我們擁有廣泛的業務範圍,這使我們能夠確保為世界各地的患者提供供應。這就是為什麼您能夠看到我們在新冠疫情等事件期間避免供應中斷的原因。

  • I mean -- and today, we have a robust US manufacturing network with more than 6,000 American workers across 11 sites. As I mentioned in my remarks, that includes manufacturing of API, biologics, toxins and small molecules.

    我的意思是——今天,我們擁有強大的美國製造網絡,在 11 個地點擁有超過 6,000 名美國工人。正如我在演講中提到的,這包括 API、生物製劑、毒素和小分子的製造。

  • For example, our largest product, Skyrizi is made in the US for the domestic market. And given our expected volume growth and our expansion into areas like obesity, as I mentioned, we'll continue increasing our US footprint with over $10 billion in planned capital invest during the next decade. In terms of potential mitigation, in the near term, we could take inventory management actions or secure alternate sources of API.

    例如,我們最大的產品 Skyrizi 是在美國製造,面向國內市場。鑑於我們預期的銷售成長以及我們在肥胖等領域的擴張,正如我所提到的,我們將繼續擴大我們在美國的業務範圍,在未來十年內計劃投資超過 100 億美元。就潛在的緩解措施而言,在短期內,我們可以採取庫存管理措施或確保 API 的替代來源。

  • We could also look at cost efficiencies and productivity initiatives as a source of mitigation, which we always do. I think what's more challenging is trying to pass the tariff impacts to our customers, especially with penalties in the government channel and with existing contracts in the commercial setting. So I don't see that as a viable source for mitigation. Now longer term, we will add more US manufacturing capacity, which is part of the planned capital investment of over $10 billion.

    我們也可以將成本效率和生產力措施視為緩解措施的來源,我們一直都是這樣做的。我認為更具挑戰性的是試圖將關稅影響轉嫁給我們的客戶,特別是政府管道的處罰和商業環境中的現有合約。所以我不認為這是一種可行的緩解方法。從長遠來看,我們將增加美國的製造產能,這是超過 100 億美元計畫資本投資的一部分。

  • So specific to 2025, we would look to mitigate the impact as much as possible with a combination of supply chain actions, cost efficiencies and any additional overperformance from our growth platform. But in the meantime, we have enough confidence in the momentum of our business to raise our guidance this year, which should be viewed as a positive.

    因此,具體到 2025 年,我們將透過供應鏈行動、成本效率以及成長平台的任何額外超額表現來盡可能減輕影響。但同時,我們對業務發展勢頭有足夠的信心,因此提高了今年的業績預期,這應該被視為積極的一面。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • Yes. then, Dave, with respect to IP. IP has been looked at, I think, when people try to assess the impact of potential tariffs on our sector. IP has been looked at as kind of a proxy as to what that impact might be. And certainly, directionally, I think that is something that would be somewhat telling.

    是的。然後,戴夫,關於 IP。我認為,當人們試圖評估潛在關稅對我們行業的影響時,智慧財產權就受到了關注。IP 已被視為衡量這種影響的代理。當然,從方向來看,我認為這是有一定說明意義的。

  • That said, when we look at our profile overall, Rob mentioned the strong US presence that we have. But we don't see our profile suggesting any sort of outsized impact for us as a company. The tax rate is something that you can look at, which is essentially when you think of the bookends of the minimum tax for earnings outside the US, for tax earned -- or income earned in the US, that really kind of aligns with where that IP is structured. And that blending of your income is kind of produces generally, directionally your tax rate you see us being relatively in line with our peers.

    話雖如此,當我們從整體上看我們的形象時,羅布提到了我們在美國強大的影響力。但我們並不認為我們的形象會對我們公司產生任何巨大影響。稅率是您可以查看的內容,本質上,當您考慮美國境外收入的最低稅率、所得稅款或在美國獲得的收入時,這實際上與 IP 的結構相符。而您的收入的混合通常會產生方向性的稅率,您會看到我們的稅率與同行相對一致。

  • And so that suggests that we have a similar IP profile from an overall perspective. I'd also just quickly point out that sometimes with Allergan, as that was a company that we [redomiciled] back to the US, it was a foreign headquarter company. We call that Allergan was a series of several companies that were put together over a few years. And those companies all have significant US presence as well.

    這顯示從整體角度來看我們擁有相似的 IP 概況。我還要快速指出的是,對於艾爾建公司來說,由於該公司是我們遷回美國的公司,因此它是一家外國總部公司。我們稱艾爾建為一系列經過數年時間組成的公司。這些公司在美國也都佔有重要地位。

  • So Allergan profile is not dissimilar from ours as a whole either. So I think when you think about that IP profile, it is important from a tariff perspective. It's also very important from a tax reform perspective. There was a lot of progress made in leveling the playing field for US companies in 2017 tax reform that did a lot of good things and really helped invest in the US as well as a competitive environment for our companies.

    因此,艾爾建公司的整體情況與我們的情況並無不同。因此我認為,當你考慮 IP 概況時,從關稅角度來看它很重要。從稅改的角度來看這也非常重要。2017 年稅改在為美國企業創造公平競爭環境方面取得了很大進展,這產生了許多積極影響,確實促進了對美國的投資,也為我國企業創造了一個競爭環境。

  • We see it as an important piece of building upon that tax reform to encourage further and long term, as I mentioned in my remarks, a sustainable investment. So I see a tax reform initiative building on 2017, coupled with tariffs as something that will encourage US manufacturing over the long term, and we feel very good about our profile right now.

    我們認為這是稅務改革的重要組成部分,旨在鼓勵進一步的長期永續投資,正如我在演講中提到的那樣。因此,我認為 2017 年的稅改措施加上關稅將長期促進美國製造業的發展,我們對目前的狀況感到非常滿意。

  • Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

    Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

  • Hi, it's Roopal, and I'll answer the 295 question regarding the multiple ascending dose study. Currently, with the data you've seen, we're at 1 and 2 milligrams, and we have the opportunity here in this study to go several fold higher than the 2 milligrams. And we also have the opportunity to go beyond six weeks, namely around 12 weeks before we get into formal Phase 2b, which I would say, around next year, which we would go quite a bit longer. The sample size, what you've seen here may be a little bit larger because of the multiple ascending dose format here. we'll see larger sample sizes once we get into the formal Phase 2b.

    你好,我是 Roopal,我將回答有關多次遞增劑量研究的第 295 個問題。目前,根據您所看到的數據,我們的濃度為 1 毫克和 2 毫克,而在本研究中,我們有機會將濃度提高到 2 毫克以上的幾倍。我們也有機會超越六週,也就是在進入正式的第 2b 階段之前大約 12 週,我想說,大約在明年,我們會持續更長時間。樣本量,您在這裡看到的可能稍微大一些,因為這裡採用了多劑量遞增格式。一旦進入正式的第 2b 階段,我們將看到更大的樣本量。

  • The other opportunities here are also to look at titration at the 1 milligram or maybe even lower. We don't see any adverse events beyond suppression of appetite. So there's an opportunity to be able to start low and start titrating up to doses quite a bit higher than 2 milligrams, but we're open to watch this study and be flexible.

    這裡的其他機會也是觀察 1 毫克甚至更低濃度的滴定。除了抑制食慾之外,我們沒有看到任何不良事件。因此,有機會從低劑量開始,然後逐漸增加劑量至遠高於 2 毫克的劑量,但我們願意觀察這項研究並保持靈活性。

  • The other important findings would be around muscle and bone. So those would be other things that will be evaluated as well as looking at dosing, the half-life is around 270 hours. So that could give us an opportunity to go twice a month and even potentially monthly. So all that will be captured in this data set. We expect to see some data next year, and then that will allow us to best design a more formal Phase 2b study.

    其他重要發現與肌肉和骨骼有關。因此,除了劑量之外,還需要評估其他事項,半衰期約 270 小時。這樣我們就有機會每個月去兩次,甚至每個月去一次。所以所有這些都將被捕獲在這個資料集中。我們預計明年會看到一些數據,然後這將使我們能夠最好地設計更正式的 2b 期研究。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝,特倫斯。接線員,請問下一個問題。

  • Operator

    Operator

  • Carter Gould, Cantor.

    卡特·古爾德,領唱者。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • Good morning. Thanks for taking the question. Obviously, there's been a lot of discussion around drug pricing kind of resurfacing and some rumblings around most favored nation, kind of bubbling back to the surface. I wanted to get a sense of understanding of your expectations and flexibility, if need be to take actions outside the US?

    早安.感謝您回答這個問題。顯然,有關藥品定價的討論已經重新浮出水面,而有關最惠國待遇的一些爭論也再次浮出水面。我想了解您的期望和靈活性,如果需要在美國境外採取行動?

  • And then maybe more of a commercial question as we think about the potential co-administration of BoNT/E and Botox. Can you kind of help frame how you think that would impact the market? Is this something that could just grow the overall pie, move share, et cetera? Any thoughts on that front would be appreciated. Thank you.

    當我們考慮 BoNT/E 和 Botox 的潛在聯合使用時,這可能更多的是一個商業問題。您能否解釋一下這會對市場產生什麼影響?這是否可以增加整體份額、提高市場佔有率等等?任何有關這方面的想法都將受到讚賞。謝謝。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • Hey, Carter, it's Rob. I'll take your first question, and then Jeff will take the second question. I think the -- as we've study the environment. I mean we are very supportive of a balanced approach that addresses affordability while also encouraging innovation. And you've seen many of our peers reinforcing the importance for the EU to properly value innovation, which we echo and would support any policies that had encouraged that outcome.

    嘿,卡特,我是羅布。我來回答你的第一個問題,然後傑夫來回答第二個問題。我認為——我們已經研究過環境了。我的意思是,我們非常支持一種平衡的方法,既解決可負擔性問題,又鼓勵創新。你已經看到我們的許多同行都在強調歐盟正確重視創新的重要性,我們對此表示贊同,並支持任何鼓勵這項結果的政策。

  • That said, we hope the administration contemplates the harm that international reference pricing could have on US health care, the US health care industry and future innovation. I think anything like price controls cost increases or higher tax, it just leaves less investment available across the industry to advance new innovative medicines. That said, I'm very encouraged by the administration's willingness to address the pill penalty in the IRA and is fixing that would support long-term innovation in our industry.

    儘管如此,我們希望政府能考慮國際參考定價可能對美國醫療保健、美國醫療保健產業和未來創新造成的危害。我認為,任何諸如價格控制、成本增加或提高稅收的行為都會導致整個產業用於推進新創新藥物的投資減少。話雖如此,我對政府願意解決 IRA 中的藥丸懲罰問題感到非常鼓舞,並且正在修復該問題以支持我們行業的長期創新。

  • And so as we look at the push, I think, for the EU to more properly value. The innovation is an absolute appropriate push. We're encouraged by some of the policies that really support innovation. And Scott also talked about tax reform. And I think that's an important lever as well as we think about one of the things that will drive investment in the US and drive more innovation.

    因此,當我們審視這項推動力時,我認為,歐盟應該更加重視這一點。這項創新絕對是適當的推動。一些真正支持創新的政策令我們感到鼓舞。斯科特也談到了稅制改革。我認為這是一個重要的槓桿,也是我們考慮推動美國投資和推動更多創新的因素之一。

  • I think if you just look at AbbVie as an example, we've invested over $5 billion of capital since tax reform in 2017. I mean, that includes a new oncology research center in South San Francisco. That includes Skyrizi manufacturing capabilities in the US, eye care capacity expansion in Waco, Texas and technology infrastructure upgrades across our footprint, just to name a few.

    我認為,如果僅以 AbbVie 為例,自 2017 年稅制改革以來,我們已經投資了超過 50 億美元的資金。我的意思是,這包括位於南舊金山的一個新的腫瘤學研究中心。其中包括在美國的 Skyrizi 製造能力、在德克薩斯州韋科的眼保健能力擴張以及我們業務範圍內的技術基礎設施升級,僅舉幾例。

  • And importantly, as Scott mentioned, tax reform allowed us to acquire Allergan, an Irish domicile company, that we then redomiciled into the US. I mean, that transaction enabled AbbVie to continue increasing our R&D investment through the Humira LOE, which is unprecedented.

    重要的是,正如史考特所提到的,稅制改革使我們能夠收購愛爾蘭公司艾爾建 (Allergan),然後我們將該公司遷至美國。我的意思是,這筆交易使 AbbVie 能夠透過 Humira LOE 繼續增加我們的研發投資,這是前所未有的。

  • That will ultimately -- that will help us really lead to more innovation in our pipeline and ultimately impact patients in the future. So when we think about policy, we think tax reform has provided the right incentives to invest more in the US and more in innovation. And that's what we would encourage.

    這最終將幫助我們真正引領我們的產品線的更多創新,並最終對未來的患者產生影響。因此,當我們考慮政策時,我們認為稅改提供了正確的激勵措施,以增加對美國和創新的投資。這正是我們所鼓勵的。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yes. And thank you for the question. So let me give a quick update on the BoNT/E and the combination approach in terms of how we're starting to think about it. Obviously, we're super pleased with the recent filing on BoNT/E. And as we've highlighted before, the short-acting toxin will operate on two different levels for us.

    是的。感謝您的提問。因此,讓我對 BoNT/E 和組合方法的現狀做一個簡要的介紹,說明我們是如何開始思考這個問題的。顯然,我們對最近關於 BoNT/E 的備案感到非常滿意。正如我們之前強調的那樣,短效毒素會在兩個不同的層面上發揮作用。

  • First, it will stimulate the funnel. It will basically be a market stimulator because we know there's lots of considerers in the marketplace that are just worried about going to a full strength toxin because it lasts for three to four months. So the approachability of a short-acting toxin that works in about 8.5 hours and has gone in 2.5 weeks makes the market much more approachable for the people in the consideration phase. So we think it's going to work on the market and our share because, obviously, we've done studies with Botox after BoNT/E.

    首先,它將刺激漏斗。它基本上會成為一種市場刺激因素,因為我們知道市場上有很多考慮者只是擔心毒素會達到全強度,因為它的效果會持續三到四個月。因此,一種在約 8.5 小時內起效並在 2.5 週內消失的短效毒素的可接近性使得市場對於處於考慮階段的人來說更容易接受。因此我們認為它將對市場和我們的份額產生作用,因為顯然我們在 BoNT/E 之後對 Botox 進行了研究。

  • Now in the combination use, Carter, it's very interesting. This is more of a pure sort of share play. When we talk to the consumers, many of the consumers are using a lot of Botox and you start saying, can you imagine a Botox that works almost immediately, so an immediate acting Botox.

    現在,卡特,組合使用非常有趣。這更像是一種純粹的股份遊戲。當我們與消費者交談時,許多消費者都在使用大量的肉毒桿菌毒素,你開始說,你能想像一種幾乎立即起效的肉毒桿菌毒素嗎,所以是一種立即起效的肉毒桿菌毒素。

  • That gives us the potential, and we'll have to see how those trials and those studies play out to actually restate the whole market. Because what's remarkable about BoNT/E is that we can see a two-grade change in the glabellar lines in 8.5 hours. So nothing has ever worked even close to that fast.

    這給了我們潛力,我們必須看看這些試驗和研究如何發揮作用,才能真正重塑整個市場。因為 BoNT/E 的顯著特徵是,我們可以在 8.5 小時內看到眉間紋發生兩級變化。因此,沒有任何東西可以達到如此快的速度。

  • So we could even have a premium toxin that sits alongside Botox one day, or a replacement product for just simply a better Botox and immediate acting Botox. So it gives us a lot of flexibility, and it's certainly very exciting as Roopal has highlighted, the program that will begin here for the combination.

    因此,我們甚至可能有一天會擁有一種與肉毒桿菌素相媲美的優質毒素,或者一種替代產品,即更好的肉毒桿菌和速效肉毒桿菌。因此,它為我們提供了巨大的靈活性,而且正如 Roopal 所強調的那樣,這個組合計劃將從這裡開始,這當然非常令人興奮。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Carter. Operator, next question please.

    謝謝,卡特。接線員,請問下一個問題。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    考特尼·布林,伯恩斯坦。

  • Courtney Breen - Analyst

    Courtney Breen - Analyst

  • Hi, thanks for taking the question today. I wanted to look back to kind of part of the inventory and tariff conversation. We've been able to get some explicit answers from some of the peer companies. So I just wanted to see if you were able to give us context as to whether you have enough inventory in the US to support products like Rinvoq, Botox, VRAYLAR or Humira for the rest of this year? And what about '26 and '27?

    嗨,感謝您今天回答這個問題。我想回顧一下庫存和關稅的討論部分。我們從一些同業公司得到了一些明確的答案。所以我只是想看看您是否能夠告訴我們您在美國是否有足夠的庫存來支援今年剩餘時間內的 Rinvoq、Botox、VRAYLAR 或 Humira 等產品?那麼 26 年和 27 年的情況如何?

  • And then the second question is just on the back of the prior BoNT/E question. Can you give us a little bit of context as to the pricing strategy for that kind of tester market because arguably kind of with a shortage or acting time horizon, you have kind of less value. And so I'd love to see -- understand a little bit more about how you're thinking about placing these products together? Thank you.

    第二個問題正好與先前的 BoNT/E 問題相關。您能否向我們介紹一下這種測試市場定價策略的背景,因為可以說,如果出現短缺或作用時間範圍,您的價值就會降低。所以我很想看看——進一步了解一下您是如何考慮將這些產品組合在一起的?謝謝。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • This is Rob. I'll take your first question, and Jeff will take the second. Look, absent policy details, we're not going to get into speculating on the impact. I think you've known us to be a company that once we have a full understanding, we're very transparent and detailed.

    這是羅布。我來回答你的第一個問題,傑夫來回答第二個問題。你看,由於缺乏政策細節,我們不會對其影響進行猜測。我想您已經知道我們是一家一旦有了充分了解就會非常透明和詳細的公司。

  • If you think about how we approach the Part D benefit redesign, as soon as we understood that impact, we were well in advance of the implementation of that discussing the impact on the company. But with tariffs, we don't have the policy details for the sectoral tariffs. So it's premature to speculate on the impact. And once we have that information, we'll communicate at the appropriate time.

    如果您想想我們如何對待 D 部分福利重新設計,那麼一旦我們了解了其影響,我們就會提前討論其對公司的影響。但關稅,我們沒有分產業關稅的政策細節。因此,現在推測其影響還為時過早。一旦我們獲得這些訊息,我們將在適當的時候進行溝通。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yes. And regarding the pricing, obviously, it's -- since we just had the filing, it's premature. We go through a very rigorous pricing analysis as we would get closer to the launch. And some of the considerations that we would look for, which is, obviously, as I mentioned, the rotation of even more patients into the aesthetic practices brings a lot of value to those practices.

    是的。至於定價,顯然,由於我們剛剛提交文件,所以現在還為時過早。隨著產品發布的臨近,我們會進行非常嚴格的定價分析。我們會尋找的一些考慮因素,顯然,正如我所提到的,讓更多的患者輪流接受美容治療會為這些治療帶來很多價值。

  • And if you think about it, the lifetime value of those new patients is very meaningful. So that could play into dynamics ultimately how we price the BoNT/E once we ultimately make that decision sometime next year. Obviously, it does work shorter. So that might imply a different or lower price point to start the trial. But those are all considerations commercially that we will go through as we go through our launch readiness process over the course of the year to really optimize the impact of that product as we bring it to the market.

    如果你仔細想想,這些新病人的終身價值是非常有意義的。因此,一旦我們最終在明年某個時候做出決定,這最終可能會影響我們如何為 BoNT/E 定價。顯然,它確實能縮短工作時間。因此這可能意味著開始試用的價格點會有所不同或更低。但這些都是商業上的考慮,我們將在今年的發布準備過程中考慮這些因素,以便在將產品推向市場時真正優化其影響力。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝,考特尼。接線員,請問下一個問題。

  • Operator

    Operator

  • Mohit Bonsal, Wells Fargo.

    富國銀行的 Mohit Bonsal。

  • Mohit Bonsal - Analyst

    Mohit Bonsal - Analyst

  • Okay, thank you very much for taking my question. Congrats on all the progress. I would love to understand a little bit more about your thought process around Gubra handling and there have been a couple of strategies. So of course, Novo is trying to combine (inaudible), but then there is a strategy or thought process that Amlin could be a good agent as a stand-alone agent. So how are you thinking about this, especially with the longer-acting version? Do you think there is a strategy to just use this as a single agent, especially among patients who cannot tolerate (inaudible)? Would love to get your thoughts here. Thank you.

    好的,非常感謝您回答我的問題。祝賀你取得的所有進展。我很想進一步了解您對 Gubra 處理的思考過程,並且已經提出了一些策略。因此,Novo 當然正在嘗試結合(聽不清楚),但有一個策略或思考過程,即 Amlin 可以成為一種優秀的獨立藥物。那麼您對此有何看法,尤其是對於長效版?您認為是否存在一種策略可以僅將其作為單一藥物使用,特別是對於無法耐受的患者(聽不清楚)?我很想聽聽您的想法。謝謝。

  • Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

    Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

  • Mohit, it's Roopal. I'll take that. So thanks for highlighting some of the potential here. And I think, we're thinking about it quite broadly. So as you stated, there's an opportunity here as a monotherapy. I think the way we think about it is tolerability is key. We see a number of dropouts, upwards of 30% even after a month of starting with the current set of assets.

    Mohit,我是 Roopal。我會接受的。所以感謝您強調這裡的一些潛力。我認為我們正在對此進行廣泛的思考。因此,正如您所說,這裡存在作為單一療法的機會。我認為我們思考這個問題的方式是耐受性是關鍵。我們發現,即使使用目前資產一個月後,退出率仍高達 30% 以上。

  • And then when we look over the course of the year, 60% to 70% of the patients will drop. Now there's a variety of factors that drive that discontinuation, but a key component is tolerability. So to have a monotherapy that's tolerable, that provides meaningful weight loss, and potentially has other potential benefits. We've seen preclinically preservation of muscle.

    然後,當我們回顧這一年時,我們發現患者人數會下降 60% 到 70%。現在有多種因素導致停藥,但一個關鍵因素是耐受性。因此,需要一種可以耐受的單一療法,可以顯著減輕體重,並可能具有其他潛在益處。我們已經看到了臨床前的肌肉保存。

  • We will have to see if that plays out. But that could be another benefit in the long term. When this launches, we do anticipate many of the patients will have already been on assets that are available today. So it could serve as a nice follow-on for folks that couldn't tolerate or came off for other reasons and want to go somewhere else.

    我們將拭目以待,看看結果是否如此。但從長遠來看,這可能是另一個好處。當這項服務啟動時,我們確實預期許多患者已經使用了目前可用的資產。因此,對於那些無法忍受或因其他原因離開並想去其他地方的人來說,它可以成為一個很好的後續選擇。

  • Now in terms of combinations, recall, when we did this deal, one thing we liked about it was also the neutral pH of the formulation. So that could enable combinations with a variety of mechanisms. And as Rob stated, we are interest -- continue to be interested in this space, and we'll be thinking about other potential opportunities, which could include combinations that may drive further weight loss. But key for us would be tolerability and durable durability of use.

    現在就組合而言,回想一下,當我們做這筆交易時,我們喜歡的一件事也是配方的中性pH值。這樣就可以實現與多種機制的組合。正如羅布所說,我們感興趣——繼續對這個領域感興趣,我們會考慮其他潛在的機會,其中可能包括可能進一步推動減肥的組合。但對我們來說關鍵的是耐受性和持久耐用性。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Mohit. Operator, next question please.

    謝謝,Mohit。接線員,請問下一個問題。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉 (Steve Scala),TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Thank you so much. Two questions. First of all, Bristol appears to think there's a path forward with (inaudible) in adjuvant schizophrenia, based on existing data. Where does AbbVie stand in its analysis of the future of emaracladine, for instance, has a path forward become more clear in the last few months?

    太感謝了。兩個問題。首先,根據現有數據,布里斯托似乎認為輔助治療精神分裂症有一條前進的道路(聽不清楚)。例如,AbbVie 對 emaracladine 未來的分析立場如何?過去幾個月中,前進的道路是否變得更加清晰?

  • Secondly, I believe AbbVie has more plants in Ireland than any other company. Curious how you think about that as well as your overall OUS footprint? Do you cut back OUS to invest in the US? Or do you maintain the presence OUS given the fact that in four years, we could have a different administration with very different views?

    其次,我相信 AbbVie 在愛爾蘭的工廠比其他公司都多。好奇您對此有何看法以及您的整體 OUS 足跡?您是否削減 OUS 以在美國投資?或者,考慮到四年後我們可能會迎來一個持有截然不同觀點的不同政府,您是否會維持 OUS 的存在?

  • And related to this topic, yesterday, Roche said that their US plants are 50% utilized. I'm wondering if AbbVie would share a similar percentage? Thank you.

    與此主題相關,昨天,羅氏表示其美國工廠的利用率為 50%。我想知道 AbbVie 是否會分享類似的百分比?謝謝。

  • Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

    Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

  • It's Roopal. I'll start with the schizophrenia questions. In terms of the recent data, it's difficult for us to comment. I think that will be a discussion between the company and health authorities regarding the utility of a failed study that's -- that would be their discussion to have. How we look at emaracladine is that we do still see potential, and we want to approach this in a stepwise manner.

    是 Roopal。我將從精神分裂症的問題開始。就最近的數據而言,我們很難發表評論。我認為這將是公司和衛生當局之間關於失敗研究的效用的討論——這將是他們的討論。我們對 emaracladine 的看法是,我們確實仍然看到潛力,我們希望逐步實現這一目標。

  • The first step would be to look to see if we can further dose escalate beyond what was previously studied. We saw variable PK levels in those patients from the pivotal studies. Some were low, and we think there's an opportunity to raise that. So a multiple ascending dose study will be initiated this year. And that would apply to potentially monotherapy in schizophrenia as well as the adjunctive setting.

    第一步是觀察是否可以進一步提高劑量,超越先前的研究範圍。我們從關鍵研究中看到了這些患者的不同 PK 水平。有些水平較低,我們認為有機會提高這一水平。因此,今年將啟動一項多次遞增劑量研究。這可能適用於精神分裂症的單一療法以及輔助治療。

  • So as that data rolls out and if we're able to utilize a higher dose then we would again stepwise go forward into a Phase 2 setting to further derisk and apply our learnings in terms of trial design. And then if we see strong data there, which could be as a monotherapy, it could be as an adjunct and also in neurodegeneration psychosis, then we would move into the Phase 3 setting. But I would say we still believe there's opportunity here.

    因此,隨著數據的推出,如果我們能夠使用更高的劑量,那麼我們將再次逐步進入第二階段,以進一步降低風險並將我們的經驗應用於試驗設計。然後,如果我們看到強有力的數據,它可以作為單一療法,可以作為輔助療法,也可以用於治療神經退化性精神病,那麼我們就會進入第 3 階段。但我想說我們仍然相信這裡有機會。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • Then Steve, this is Rob. I'll take your question on the manufacturing footprint. As I mentioned in my remarks earlier, obviously, AbbVie, we have a very broad footprint. An important part of the strategy is to assure supply. And as I mentioned earlier, we went through a global pandemic without any supply disruptions and that strategy certainly paid off.

    那麼史蒂夫,這是羅布。我將回答您關於製造足跡的問題。正如我之前在評論中提到的,顯然,AbbVie 的業務範圍非常廣泛。該戰略的一個重要部分是保證供應。正如我之前提到的,我們經歷了一場全球大流行,但供應沒有中斷,這項策略無疑取得了成效。

  • We also have, I'd say, a very robust manufacturing network in the US. I think what's been widely misunderstood is, Skyrizi as an example, our largest product is made in the US. And so when we look at our global footprint, we consider assurance of supply.

    我想說,我們在美國還擁有非常強大的製造網絡。我認為人們普遍誤解的是,以 Skyrizi 為例,我們最大的產品是在美國製造的。因此,當我們審視我們的全球足跡時,我們會考慮供應保證。

  • As Scott mentioned earlier, clearly, obviously, tax has an influence on longer term, how you'd want to structure your supply chain. So certainly, I think with a more competitive tax policy that sort of provide the appropriate incentives.

    正如史考特之前提到的,顯然,稅收會對你的長期供應鏈結構產生影響。因此,我認為更具競爭力的稅收政策可以提供適當的誘因。

  • We try to say -- we have obviously been ramping our volume considerably. You look at just the performance just with -- think about biologics capacity and just the tremendous ramps we've seen for Skyrizi and Rinvoq. And so we stay ahead of the curve. We ensure that we are investing appropriately so we can keep up with that demand. I'd say the commercial team puts a lot of pressure on operations because they're performing so well, but operations stays ahead of the curve and invest appropriately.

    我們試圖說——我們顯然已經大幅提高了我們的銷量。你只需看看性能——想想生物製劑的產能以及我們看到的 Skyrizi 和 Rinvoq 的巨大增長。因此我們始終保持領先地位。我們確保進行適當的投資,以便能夠滿足此需求。我想說的是,商業團隊對營運施加了很大的壓力,因為他們的表現非常好,但營運始終保持領先地位並進行適當的投資。

  • And so when we look at the investment, and when I mentioned the greater than $10 billion investment, that takes into account in the US that takes into account our volume growth that we expect, in addition to new areas that we will invest.

    因此,當我們考慮投資時,當我提到超過 100 億美元的投資時,這考慮到了美國,考慮到了我們預期的銷售成長,以及我們將投資的新領域。

  • For example, peptide manufacturing as an example, as we enter that space, obviously, now as we enter into obesity, it makes sense to add that capability. And so that will also be part of our supply chain strategy here. So that's the way we're thinking about it.

    例如,以勝肽製造為例,當我們進入這個領域時,顯然,現在當我們進入肥胖領域時,添加這種能力是有意義的。這也將成為我們供應鏈策略的一部分。這就是我們思考這個問題的方式。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • All right, thanks Steve. Operator, next question please.

    好的,謝謝史蒂夫。接線員,請問下一個問題。

  • Operator

    Operator

  • Dave Risinger, Leerink Partners.

    Dave Risinger,Leerink Partners。

  • Dave Risinger - Analyst

    Dave Risinger - Analyst

  • Thanks very much and congrats on the performance. So I have two questions, please. and they're both a bit high level. So the first is the industry is facing three major US government risks, actions that are harming biopharma innovation, including significant FDA disruption and questioning of proven medical science, tariff threats and also the Trump administration's agenda to take prices down more than the Biden administration took down drug prices.

    非常感謝,並祝賀您的表演。我有兩個問題。而且他們的水平都有點高。因此,首先,該行業面臨美國政府的三大風險,這些行動正在損害生物製藥創新,包括 FDA 的嚴重干擾和對已證實的醫學科學的質疑、關稅威脅,以及川普政府降低價格的議程,其幅度超過了拜登政府降低藥品價格的議程。

  • So considering what appears to be a lack of appreciation in Washington of the benefits that the biopharmaceutical industry brings to Americans, can you please comment on how your executive team and Board are engaging differently today with Washington leadership to change the political agenda for the better?

    因此,考慮到華盛頓似乎對生物製藥行業為美國人帶來的好處缺乏認識,您能否評論一下您的執行團隊和董事會今天如何以不同的方式與華盛頓領導層接觸,以改變政治議程?

  • And then second, the press release mentions that guidance doesn't reflect any trade policy shifts, including pharmaceutical sector tariffs. Can you describe the potential trade policy shifts that you're considering or thinking of beyond tariffs? Thank you.

    其次,新聞稿中提到,該指南並未反映任何貿易政策變化,包括製藥業關稅。您能否描述一下除了關稅之外您正在考慮或正在考慮的潛在貿易政策變化?謝謝。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • I'll take the first question, Roopal, you can certainly add on as it relates to FDA, and then Scott, you can take that the last question. So we're obviously not a member of pharma today, AbbVie, but we do continue to communicate with the association really to seek alignment on the most critical issues for the industry. Now AbbVie has a large government affairs organization that engages with lawmakers and the administration on our top policy priorities. And that includes tax reform. We've talked about that quite a bit today.

    我來回答第一個問題,Roopal,你當然可以補充與 FDA 相關的內容,然後 Scott,你可以回答最後一個問題。因此,我們今天顯然不是製藥公司 AbbVie 的成員,但我們確實會繼續與協會溝通,以尋求在行業最關鍵問題上的一致性。現在,艾伯維擁有一個大型政府事務組織,負責與立法者和政府就我們的首要政策重點進行溝通。其中包括稅改。我們今天已經談論過這個問題很多次了。

  • IRA, 340B and patient affordability in Medicare. And we have actually seen some positive results from that engagement. I mean, just this week, Congress released a report on 340B, which included a recommendation that changed the lot to more clearly define a patient which should help address the abuse that is occurring with this program.

    IRA、340B 和醫療保險中的病患負擔能力。我們確實看到了此次合作的一些正面成果。我的意思是,就在本週,國會發布了一份關於 340B 的報告,其中包括一項建議,對所有內容進行了修改,以更明確地定義患者,這應該有助於解決該計劃中發生的濫用問題。

  • I would also view the 340B policies in the latest executive order is a positive. I also previously mentioned that seeking to eliminate the pill penalty is a positive for innovation. So we will continue to work with lawmakers as we always have on policies that support a healthy US biopharma industry, continued innovation and patient affordability.

    我還認為最新行政命令中的 340B 政策是積極的。我之前也提到過,尋求消除藥丸懲罰對創新來說是件好事。因此,我們將一如既往地繼續與立法者合作,制定支持美國生物製藥產業健康發展、持續創新和患者可負擔能力的政策。

  • Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

    Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

  • Hi, it's Roopal regarding FDA interactions. I would say our teams have been in active discussions with the FDA on multiple programs across therapeutic areas, sometimes daily interactions and no signals of a slowdown. We are monitoring the situation closely. However, thus far, we haven't experienced any delays to our time lines.

    你好,我是 Roopal,關於 FDA 相互作用。我想說的是,我們的團隊一直在與 FDA 就多個治療領域的計畫進行積極討論,有時每天都進行互動,而且沒有放緩的跡象。我們正在密切關注局勢。然而,到目前為止,我們的時間表還沒有出現任何延誤。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • And it's Scott, just with respect to your question on my initial comments. It's just the trade policy shift we're talking about here is the pharmaceutical sector tariff with the potential pharmaceutical sector tariffs. It's not any additional things that we were contemplating. Certainly, the environment has some uncertainty out there, but specific to that comment, we were speaking of the pharmaceutical sector tariffs.

    我是斯科特,關於你對我最初的評論提出的問題。我們在這裡談論的貿易政策轉變是製藥業關稅和潛在的製藥業關稅。我們所考慮的並不是其他的事情。當然,環境存在一些不確定性,但具體到該評論,我們談論的是製藥業的關稅。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks David. Operator, next question please.

    謝謝大衛。接線員,請問下一個問題。

  • Operator

    Operator

  • Vamil Divan, Guggenheim Securities.

    瓦米爾·迪萬,古根漢證券公司。

  • Vamil Divan - Analyst

    Vamil Divan - Analyst

  • Hi, thanks for taking my questions. Congrats on the quarter. And I don't think you addressed this. Sorry if I missed some of this, but one of the tariff discussions. I was curious about the aesthetics side. I know pharmaceutical products that's (inaudible) and Juvederm may be included right now. So curiosities the case or not? And if it is and why wouldn't there be some -- how you put that in your new guidance, or maybe you just absorb it within your guidance? Any impact there?

    你好,謝謝你回答我的問題。恭喜本季取得佳績。我不認為你提到了這一點。抱歉,我錯過了一些內容,但這是其中一次關稅討論。我對美學方面很好奇。我知道現在可能包括醫藥產品(聽不清楚)和 Juvederm。那麼這是否令人好奇呢?如果是的話,為什麼不會有一些——您如何將其納入您的新指導中,或者您只是將其吸收到您的指導中?有影響嗎?

  • And then second (inaudible) aesthetic side, I appreciate the macro issues and all the macroeconomic pressures. But I'm just curious if you can comment on the market share dynamics? And is there any sort of share shift that you're seeing either in toxins or pillars that may be impacting things beyond the macro compose? Thanks.

    然後第二個(聽不清楚)美學方面,我欣賞宏觀問題和所有宏觀經濟壓力。但我只是好奇您是否可以評論一下市場份額動態?您是否看到毒素或支柱方面的任何份額轉變可能會對宏觀構成以外的事物產生影響?謝謝。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • Thanks, Vamil, it's Scott. You are right. It's a great question regarding the current tariff rules that are in place. So in general, pharmaceutical products and our products are exempt from those similar to our peers. However, there was a couple of exceptions to that.

    謝謝,瓦米爾,我是史考特。你是對的。關於現行關稅規則,這是一個很好的問題。所以一般來說,醫藥產品和我們的產品都不受與同業類似的產品的影響。然而,也有幾個例外。

  • And then specific to aesthetics, yes, there are some application of the rules to aesthetics. But we have absorbed the aesthetics impact in the guidance. And I would tell you it's modest. It's something approximately $30 million. So something fairly modest in the current rules, and that's something that we have absorbed. So all of the guidance that I gave and reaffirmed today from the margin profiles and otherwise includes us absorbing that.

    然後具體到美學,是的,有一些規則可以應用於美學。但我們在引導中吸收了美學的影響。我會告訴你這是謙虛的。大約是 3000 萬美元。因此,現行規則中有些內容相當溫和,我們已經吸收了這些內容。因此,我今天從保證金概況和其他方面給出和重申的所有指導都包括我們吸收這一點。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yes. And Vamil, it's Jeff. So I'll go over your market share, give you some flavor on that, and I'll for our two big markets, the US and China. So as I mentioned, we were right on our guidance, right on our forecast for the first quarter.

    是的。瓦米爾 (Vamil),就是傑夫 (Jeff)。因此,我將介紹一下你們的市場份額,讓你們對此有所了解,我還將介紹我們的兩個大市場,美國和中國。正如我所提到的,我們的指導和對第一季的預測都是正確的。

  • Remember, the biggest impact there was the price because we reversed the alley redesign from last year. And so when we looked at basically what happened from the third quarter to the first -- the fourth quarter to the first quarter, we know we took a market share hit in toxins in that fourth quarter.

    請記住,最大的影響是價格,因為我們推翻了去年的小巷重新設計。因此,當我們回顧第三季度到第一季、第四季度到第一季度發生的情況時,我們知道我們在第四季度的毒素市場份額受到了打擊。

  • The good news is we've seen a complete reengagement in the -- basically the old alley program with all of our accounts. So things are quite stable. And we actually had a one market share point gain back from where we were.

    好消息是,我們已經看到舊的小巷計劃已經完全恢復,並且覆蓋了我們所有的帳戶。所以情況相當穩定。我們的市場份額實際上比之前增加了一個點。

  • Now we still have to gain some more share over the course of the year to come back to where we were pre the change to alley. So we have lost year-over-year some share in toxins. In the US and filler, our share is very, very stable. We did not see a significant share impact on the filler side of the business. It's just been sort of a double-digit market pressure there.

    現在我們仍然需要在這一年中獲得更多份額,才能回到改道前的水平。因此,我們的毒素份額逐年減少。在美國和填充物中,我們的份額非常非常穩定。我們沒有看到填充劑業務的份額受到顯著影響。那裡的市場壓力一直達到兩位數。

  • Now in China, I'm quite pleased with the share performance. We've recently had a couple of significant approved pools sequentially. We have the masseter approval for Botox, which is sort of in the lower face and jaw line and also Volux which is in Juvederm.

    現在在中國,我對股票表現非常滿意。我們最近連續批准了幾個重要的資金池。我們已獲得咬肌注射 Botox 的批准,該注射位於下臉部和下顎線,此外還獲得了 Juvederm 中的 Volux 的批准。

  • So we've actually seen significant positive momentum in Botox share in China as well as positive share in filler. So it's a little variable across the board. Our big push will be to recover that share over the course of the year in the US toxin space. I hope that helps.

    因此,我們實際上看到肉毒桿菌在中國的份額以及填充劑的份額均呈現顯著的積極勢頭。所以整體來說這是一個有點變數的情況。我們的大力努力將是今年內恢復美國毒素領域的份額。我希望這能有所幫助。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Vam. Operator, next question please.

    謝謝,Vam。接線員,請問下一個問題。

  • Operator

    Operator

  • Alexandria Hammond, Wolfe Research.

    亞歷山大‧哈蒙德,沃爾夫研究公司。

  • Alexandria Hammond - Analyst

    Alexandria Hammond - Analyst

  • Thanks for taking the question and congrats on the quarter. So Skyrizi and Rinvoq have conditionally surpassed expectations, but we've been getting some questions on what might drive long-term growth in I&I as it relates to these assets. Could you comment on when we should start seeing results from your Skyrizi and Rinvoq combination trials? And as a follow-up, what combination are you most excited about from a mechanistic perspective? Thank you.

    感謝您提出這個問題,並祝賀本季取得佳績。因此,Skyrizi 和 Rinvoq 有條件地超出了預期,但我們一直在思考,與這些資產相關的哪些因素可能推動 I&I 的長期成長。您能否評論一下我們何時可以開始看到 Skyrizi 和 Rinvoq 組合試驗的結果?接下來,從機械角度來看,您最感興趣的組合是什麼?謝謝。

  • Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

    Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

  • Hi, it's Roopal. I'll start on the Skyrizi question and the combinations. So the studies have initiated and we would anticipate next year starting to see early data readouts. And I would say we're excited about several of these mechanisms. We've utilized quite a bit of data that we've already collected to see what could be the best combination.

    你好,我是 Roopal。我將從 Skyrizi 問題及其組合開始。因此研究已經開始,我們預計明年就能開始看到早期數據讀數。我想說我們對其中幾種機制感到非常興奮。我們利用已經收集的大量數據來尋找最佳組合​​。

  • And ultimately, clinical data will guide that path. But we use biopsy data, the team has applied machine learning to these data sets (inaudible), a variety of different techniques. And the ones that we like are, one, the alpha 4 beta 7 combination, we think that could be a good combination. We like ludicizumab, which is a bispecific to anti-IL-1 alpha and importantly, IL-1 beta. We see that overexpression in patients with IBD that have failed other advanced therapies.

    最終,臨床數據將指導這一進程。但是我們使用活檢數據,團隊已經將機器學習應用於這些數據集(聽不清楚),各種不同的技術。我們喜歡的是 alpha 4 beta 7 組合,我們認為這可能是個很好的組合。我們喜歡 ludicizumab,它是一種針對抗 IL-1 alpha 和重要的 IL-1 beta 的雙特異性抗體。我們發現,在其他晚期療法失敗的 IBD 患者中存在這種過度表達。

  • We see something similar for TRIM I which would be another potential combination. And then we -- as I mentioned, we also have a longer-acting an agent designed to be longer-acting TL1A that could also be a very good fit with IL-23 like Skyrizi.

    我們看到 TRIM I 也有類似的情況,這是另一個潛在的組合。然後,正如我所提到的,我們還有一種長效藥物,旨在作為長效 TL1A,它也可以與 IL-23(如 Skyrizi)很好地匹配。

  • The other thing we'll be doing since I mentioned a variety of different combinations is also capturing a number of biomarkers to see if there's any potential for treatment segmentation in the future, consistent with what we do in oncology. Thus far, no real successes. I would say maybe there's hints in TLA-1 but we're going to generate that data as well to see if there's opportunities to be able to use biomarkers in the future to segment these patients.

    既然我提到了各種不同的組合,我們要做的另一件事就是捕捉一些生物標記物,看看未來是否有治療細分的潛力,這與我們在腫瘤學領域所做的工作一致。到目前為止,還沒有真正的成功。我想說 TLA-1 中可能有一些提示,但我們也會產生該數據,看看未來是否有機會使用生物標記來細分這些患者。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • And maybe, Alexanderia, I might add, when we look at Skyrizi and Rinvoq, certainly, we're very, very pleased with the strong demand in the quarter, and that led to us taking a combined $900 million of increased guidance for the year. We've also given the long-term guidance in 2027, which we feel -- continue to feel very confident in.

    也許,亞歷山大,我想補充一點,當我們看看 Skyrizi 和 Rinvoq 時,我們當然對本季度的強勁需求感到非常非常高興,這導致我們今年的指導金額總計增加了 9 億美元。我們也給了 2027 年的長期指導,我們對此仍然充滿信心。

  • And also, I think it's worthwhile to think about -- Rinvoq has -- we'll have a second wave of indications towards the end of the decade, that will add a couple of billion dollars of sales. And we really see these two products even before the combination that Roopal spoke about as having a long runway of at least for at least the next eight years, and we feel very good about that from that perspective.

    而且,我認為值得考慮的是——Rinvoq 已經——我們將在本世紀末迎來第二波跡象,這將增加數十億美元的銷售額。而且,即使在 Roopal 所說的合併之前,我們確實也看到這兩款產品至少在未來八年內擁有很長的發展空間,從這個角度來看,我們對此感到非常滿意。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • And this is Rob. I'll just -- to add on to that. I think from strategically, we look at the company, and we have this clear runway to growth for at least the next eight years, we can use that time. And obviously, we're looking to elevate the standard of care for immunology patients. We think these combination studies are a way to accomplish that.

    這是羅布。我只是——補充一下這一點。我認為從策略角度來看,我們看待公司,我們有至少未來八年明確的成長跑道,我們可以利用這段時間。顯然,我們正在尋求提高免疫學患者的護理標準。我們認為這些組合研究是實現這一目標的一種方法。

  • But we're going to use that time to -- just as we did with Humira, we came up with Skyrizi and Rinvoq as a way to elevate the standard of care and that was the second -- that really launched into a second chapter of the company.

    但我們會利用這段時間——就像我們對 Humira 所做的那樣,我們推出了 Skyrizi 和 Rinvoq,以此來提高護理標準,這是第二次——真正開啟了公司的第二篇章。

  • The third chapter is going to be as you think about the growth beyond Skyrizi and Rinvoq, and we have the time and we're investing appropriately to identify what those drivers will be and within immunology and outside of it. I mean we have five key growth areas that we're very confident can drive growth. But obviously, you've now seen us enter the obesity space as we think about more sources of growth. And we think that's also an opportunity. So we think the company is very well positioned to grow very nicely for at least the next eight years and then use that time and the investment that's available to grow beyond that.

    第三章將探討 Skyrizi 和 Rinvoq 以外的成長,我們有時間並且正在進行適當的投資,以確定這些驅動因素是什麼,以及在免疫學內部和外部。我的意思是,我們有五個關鍵成長領域,我們非常有信心推動成長。但顯然,您現在已經看到我們進入肥胖領域,因為我們正在考慮更多的成長來源。我們認為這也是一個機會。因此,我們認為該公司完全有能力在未來至少八年內實現良好成長,然後利用這段時間和可用的投資實現超越。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks Alexandria. Operator, next question please.

    謝謝亞歷山大。接線員,請問下一個問題。

  • Operator

    Operator

  • James Shin, Deutsche Bank.

    德意志銀行的詹姆斯辛 (James Shin)。

  • James Shin - Analyst

    James Shin - Analyst

  • Hey guys, good morning. Thank you for the question. I had a question on current immunology price volume dynamics. Specifically, is the low single-digit headwind being realized? If so, is it somehow being blended where Humira is seeing outsized headwinds while Skyrizi and Rinvoq are seeing tailwinds? Or is there some sort of co-pay shifted -- or is there a shift in co-pay utilization year-over-year or sequentially? Thank you.

    大家好,早安。謝謝你的提問。我對當前免疫學價格成交量動態有疑問。具體來說,低個位數逆風是否正在實現?如果是這樣,那麼這是否在某種程度上是混合的,Humira 面臨著巨大的逆風,而 Skyrizi 和 Rinvoq 則面臨著順風?或者是否存在某種形式的共同支付轉變 - 或者共同支付利用率是否逐年或連續變化?謝謝。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • James, it's Scott. So I think I'll start with Skyrizi and Rinvoq. If you look at the first quarter, those were both driven by strong demand. Now we've talked about pricing being slightly negative for those two products on a full year basis. We did see a little bit of favorable price in the quarter, and that's just a gating issue.

    詹姆斯,我是史考特。所以我想我會從 Skyrizi 和 Rinvoq 開始。如果你看一下第一季度,你會發現這些都是由強勁的需求所推動的。現在我們討論的是,從全年來看,這兩款產品的定價略有下降。我們確實看到本季價格有一點優惠,但這只是一個門檻問題。

  • So in the quarter, probably two things. One, Jeff's organization continues to do a very good job of focusing on co-pay utilization and effectively managing that. So we saw a little bit of benefit from co-pay utilization. And then in addition, we had anticipated some channel mix changes later in the year. But those actually came to fruition a little bit earlier than we thought.

    因此本季可能會發生兩件事。首先,傑夫的組織繼續出色地專注於共同支付利用率並對其進行有效管理。因此,我們看到了共同支付利用率的一些好處。此外,我們預計今年稍後通路組合將發生一些變化。但實際上,這些目標的實現比我們想像的還要早。

  • And those factors, I would say, along with some other gating issues combined to being price favorability, but we still anticipate negative pricing headwinds on a full year basis. With respect to Humira, we talked about in the quarter and on the full year that there's a decrease in volume associated with share erosion as well as the compression of the overall molecule, so that volume is going to continue.

    我想說,這些因素以及其他一些限制問題共同影響了價格的有利性,但我們仍然預計全年價格將面臨不利因素。關於 Humira,我們在本季度和全年討論過,由於市場份額的下降以及整體分子的壓縮,其銷量有所下降,因此銷量將會持續下降。

  • I think you'll see that volume a little bit more pronounced throughout the year, but there certainly continues to be some price. You've got some unwinds of accruals that cause price impact, but you also have just the changing of the rebating dynamics as we entered into a new contract year.

    我認為,您會看到全年交易量都會更加明顯,但價格肯定會繼續上漲。有些應計項目的取消會對價格產生影響,但隨著我們進入新的合約年,回扣動態也發生了變化。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝,詹姆斯。接線員,請問下一個問題。

  • Operator

    Operator

  • Geoff Meacham, Citibank.

    花旗銀行的傑夫‧米查姆。

  • Geoff Meacham - Analyst

    Geoff Meacham - Analyst

  • Hey guys, thanks for the question. Rob, I had another one on policy. I wanted to get your perspective on PBM reform, which is often mentioned as how likely to happen this year. What would you say are the main elements that you'd want to see in reform?

    嘿夥計們,謝謝你的提問。羅布,我還有一個關於政策的問題。我想了解您對 PBM 改革的看法,人們經常提到 PBM 改革在今年發生的可能性有多大。您認為改革中希望看到的主要內容是什麼?

  • And the second one on BD. Is there a therapeutic area that you guys feel like you still have to add to? I wasn't sure if neuro remains one of the top priorities just post (inaudible), and it does seem like multiple shots on goal and metabolic disease as kind of the approach a lot of other biopharmas are taken, but I wanted to get your perspective? Thank you.

    第二部在 BD 上。你們覺得還有什麼治療領域需要補充嗎?我不確定神經學是否仍然是剛發布的首要任務之一(聽不清楚),它確實看起來像是針對目標和代謝疾病的多重嘗試,就像許多其他生物製藥公司採取的方法一樣,但我想聽聽你的看法?謝謝。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • Jeff, I'll take those questions. So on PBM reform, I think we're supportive of anything that helps with patient affordability. And so to the extent that, that improves the dynamic on patient affordability that, that is truly realized in their pockets, that's favorable. So we are supportive of the efforts there, but it's really all about making sure that we're addressing patient affordability. As it relates to business development, we obviously really like the five key growth areas that we have today.

    傑夫,我會回答這些問題。因此,關於 PBM 改革,我認為我們支持任何有助於提高患者負擔能力的措施。因此,從某種程度上來說,這提高了患者的負擔能力,真正體現在他們的口袋裡,這是有利的。因此,我們支持那裡的努力,但實際上這一切都是為了確保我們解決患者的負擔能力。就業務發展而言,我們顯然非常喜歡目前擁有的五個關鍵成長領域。

  • As I mentioned, those will certainly drive very strong growth for at least the next eight years. I think sometimes there's a misconception about neuroscience for AbbVie. It's more than just psychiatry. We have a very strong migraine franchise. It's performing exceptionally well.

    正如我所提到的,這些肯定會推動至少未來八年內非常強勁的成長。我認為有時人們對 AbbVie 的神經科學有誤解。這不僅僅是精神病學。我們擁有非常強大的偏頭痛治療特許經營權。它的表現非常出色。

  • In Parkinson's, we're seeing great results. And we've been in Parkinson's for a long time with Duopa. But as you think about the ramps we're seeing in VYALEV, the innovation we've brought those -- for those patients and then tavapadon which came from cereal, we could really start to see our Parkinson's franchise emerge. And so when I think about neuroscience, I would think about it really in four segments, their psychiatry. It's an important segment.

    在帕金森氏症治療方面,我們看到了顯著的成果。我們與 Duopa 合作研究帕金森氏症已有很長時間。但是,當你想到我們在 VYALEV 中看到的坡道,我們為那些患者帶來的創新,以及來自穀物的 tavapadon,我們真的可以開始看到我們的帕金森氏症特許經營權的出現。因此,當我思考神經科學時,我會將其分為四個部分,即精神病學。這是一個重要的部分。

  • There's migraine. There's Parkinson's and there's all of their neuro degeneration. And we obviously are investing in Alzheimer's. And so if you just look at the business development activity since the beginning of last year in neuroscience. We extended our discovery collaboration in psychiatry with getting Richter who discovered VRAYLAR.

    有偏頭痛。有帕金森氏症,還有各種神經退化疾病。我們顯然正在投資阿茲海默症。因此,如果您看一下自去年年初以來神經科學領域的業務發展活動。我們與發現 VRAYLAR 的 Richter 合作,擴大了在精神醫學領域的探索合作。

  • We added a novel mechanism for mood disorders with (inaudible) We acquired a next-generation A-beta antibody that's very promising for Alzheimer's from Alyata, and we're also investing in novel approaches for migraine disease. So we are actively investing in neuroscience. We obviously, added obesity because we do think of ourselves as being a company that's going to be very large in the next decade. So it doesn't hurt to have another source of growth and we have evaluated various options beyond the five, and we chose to move into obesity for a number of reasons.

    我們透過(聽不清楚)為情緒障礙添加了一種新機制,我們從 Alyata 獲得了一種對治療阿茲海默症非常有前景的下一代 A-beta 抗體,而且我們也正在投資治療偏頭痛疾病的新方法。因此我們正在積極投資神經科學。我們顯然增加了肥胖問題,因為我們確實認為自己是一家在未來十年內規模會非常大的公司。因此,擁有另一個成長來源並不會有什麼壞處,我們已經評估了五個以外的各種選擇,並且由於多種原因,我們選擇進入肥胖領域。

  • It's obviously an extremely attractive market. It has high prevalence and plenty of headroom for growth. It's a market that has ample space for multiple players and new entrants, and I think we're also uniquely positioned with our aesthetics business to access that channel in addition to therapeutics.

    這顯然是一個極具吸引力的市場。它具有很高的普及率和很大的成長空間。這個市場有足夠的空間容納多個參與者和新進者,而且我認為,除了治療學之外,我們的美容業務也具有獨特的優勢,可以進入這個管道。

  • And importantly, and it's something we always focus on is where are the high areas of unmet need. As we think about our portfolio, that's really what our strategy is to drive a remarkable impact for our patients by elevating standard of care. When we look at obesity, there's plenty of opportunity, whether it's, reducing GI side effects, improving body composition, a more consistent weight loss across patient types, longer lasting weight loss.

    重要的是,我們始終關注的是哪些領域存在著未被滿足的需求。當我們考慮我們的產品組合時,我們的策略實際上是透過提高護理標準為我們的患者帶來顯著的影響。當我們研究肥胖症時,有很多機會,無論是減少胃腸道副作用、改善身體組成、讓不同類型的患者更一致地減肥,還是讓減肥更持久。

  • And so as we evaluate that opportunity, we found the amylin class to be very attractive, given it's the most validated non-GLP1 mechanism for obesity and has very encouraging early data, and we believe the (inaudible) opportunity with Gubra has the potential to deliver a differentiated asset. So we will continue investing in obesity. We'll continue investing in our five key growth areas, and we think that gives us the right mix to drive growth for the long term.

    因此,當我們評估這個機會時,我們發現胰淀素類藥物非常有吸引力,因為它是治療肥胖症最有效的非 GLP1 機制,並且有非常令人鼓舞的早期數據,我們相信 Gubra 的(聽不清楚)機會有可能帶來差異化的資產。因此我們將繼續投資於肥胖問題。我們將繼續投資於我們的五個關鍵成長領域,我們認為這為我們提供了推動長期成長的正確組合。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝,傑夫。接線員,請問下一個問題。

  • Operator

    Operator

  • Tim Anderson, Bank of America.

    美國銀行的蒂姆·安德森。

  • Tim Anderson - Analyst

    Tim Anderson - Analyst

  • Thank you I have a question on drug advertising. So AbbVie is the number one spender on this. It's hard to turn on TV without seeing something like (inaudible) and that you see a very positive ROI from that level of spending. As you know, there's some occasional talk by the administration about limiting such advertising. So my question is, do you think there's any basis in reality for that?

    謝謝!我有一個關於藥品廣告的問題。因此,AbbVie 是這方面支出最多的公司。打開電視很難不看到類似(聽不清楚)的東西,而且你會看到這種支出水準帶來了非常正面的投資報酬率。如你所知,政府偶爾會談論限制此類廣告。所以我的問題是,您認為這有現實依據嗎?

  • I know you'll say it shouldn't happen, but that doesn't mean that it won't potentially happen? Then on obesity, as you noted, amylyn is long acting. Does that imply that really kind of key next part of the portfolio is a long-acting GLP. Or are you not interested in the GLP-1 space at all?

    我知道你會說這不應該發生,但這並不意味著它不會發生?至於肥胖問題,正如您所說,amylyn 具有長效作用。這是否意味著投資組合的下一個關鍵部分是長效 GLP。或者您對 GLP-1 領域根本不感興趣?

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yes. Thanks, Tim. It's Jeff. And you're right. It's difficult to know if DTC reform would take place or what it might look like. I think you're right. We're very supportive of the first amendment rights to be able to advertise. And obviously, we work with the FDA on every single claim that we make on television. If there were to be a change, we would be able to pivot. I mean we could shift our investment to disease awareness.

    是的。謝謝,蒂姆。是傑夫。你是對的。很難知道 DTC 改革是否會發生或會是什麼樣子。我認為你是對的。我們非常支持第一修正案賦予的廣告宣傳權利。顯然,我們會與 FDA 合作,就我們在電視上提出的每一個聲明進行溝通。如果發生變化,我們就能做出調整。我的意思是我們可以將投資轉向疾病意識。

  • That could help us drive because we have such leading in-place share to continue to basically invest in the right way to consumers. We certainly can move to other channels because it's not really clear if it would just be mass media or et cetera.

    這可以幫助我們推動,因為我們擁有如此領先的現有份額,可以繼續以正確的方式向消費者進行投資。我們當然可以轉向其他管道,因為目前還不清楚它是否只是大眾媒體還是等等。

  • So certainly, the whole market would take a step back if that were to happen and our brands would still be very, very competitive in terms of our ability to pivot and toggle were that to happen. So difficult to predict, but we would be, of course, planning for any of those contingencies were they to take place.

    因此,如果發生這種情況,整個市場肯定會倒退,如果發生這種情況,我們的品牌在轉變和切換能力方面仍然非常具有競爭力。很難預測,但是,如果發生任何意外情況,我們當然會做好準備。

  • Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

    Roopal Thakkar - Executive Vice President, Research & Development, Chief Scientific Officer

  • And Tim, it's Roopal regarding different mechanisms. So as stated previously, we think there's opportunity as a monotherapy and also as a potential combination. I would say we haven't ruled out any particular mechanism that we would combine with.

    提姆,這是關於不同機制的 Roopal。因此,如前所述,我們認為它既有作為單一療法的機會,也有作為潛在組合的機會。我想說的是,我們並沒有排除任何可以結合的特定機制。

  • The other thing to mention, I think I already stated this, but we do have a neutral pH in the current formulation for 295. So that potentially makes it more amenable to combinations. But mechanisms that you mentioned and potentially others, I would say, are on the table for us.

    另一件要提的事情是,我想我已經說過了,但我們在 295 的當前配方中確實有一個中性 pH 值。因此,這可能使其更適合組合。但我想說,您提到的機制以及其他可能的機制我們都已考慮過。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝,蒂姆。接線員,請問下一個問題。

  • Operator

    Operator

  • Trung Huynh, UBS.

    Trung Huynh,瑞銀。

  • Trung Huynh - Analyst

    Trung Huynh - Analyst

  • Great, thanks. I've got two questions, if I can. So first, just very quickly, you did touch on the pricing dynamics with Skyrizi and Rinvoq, but did the strong performance include any notable onetime contributions, inventory build or pull-forward effects?

    太好了,謝謝。如果可以的話,我有兩個問題。首先,您確實快速談到了 Skyrizi 和 Rinvoq 的定價動態,但強勁的表現是否包括任何顯著的一次性貢獻、庫存建設或前拉效應?

  • And then second, similar to Vamil's aesthetics question. But China reciprocal tariffs have been enacted. Is that contemplated in your guide? And is that material to your aesthetics business? And then just -- I know it's early days, but are you seeing any shifts in demand there? Thank you.

    第二,類似於 Vamil 的美學問題。但中國已經實施了互惠關稅。您的指南中考慮到這一點了嗎?這對您的美學業務重要嗎?然後——我知道現在還為時過早,但您是否看到那裡的需求有任何變化?謝謝。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • Trung, it's Scott. I'll answer your questions. Thanks for the questions. So with respect to Skyrizi and Rinvoq, I would say the one item that I would point to, again, this was strong demand overall. The one thing that also helped the growth in the quarter was with respect to the retailer destocking.

    Trung,我是 Scott。我會回答你的問題。感謝您的提問。因此,關於 Skyrizi 和 Rinvoq,我想說的是,我要再次指出的一點是,整體需求強勁。零售商去庫存也對本季的成長起到了推動作用。

  • So in the past, we've talked about there's some retail inventory buildup as a form of price speculation in the fourth quarter. I talked about on the fourth quarter call that we didn't see a lot of that. And then that was again confirmed, we did not see -- there was no unwind like there has been in prior years. So there was a year-over-year benefit from the lack of destocking from the retail build up in the first quarter. But again, that was fairly modest.

    過去,我們曾討論過第四季度零售庫存增加是一種價格投機。我在第四季電話會議上說過,我們並沒有看到太多這樣的情況。然後這再次得到證實,我們沒有看到——沒有像前幾年那樣出現放鬆。因此,由於第一季零售業庫存沒有減少,因此同比增長。但同樣,這還是相當溫和的。

  • When we talk about our overall growth globally, 72% operationally, the demand was really in the 60s. And so you just saw a small portion from that retail destock backing. With respect to the China tariff, yes, you're right. There is some impact for aesthetics in those products in those numbers. But again, that impact is fairly modest. We've contemplated that in our guidance.

    當我們談論全球整體成長時,營運成長了 72%,而需求實際上在 60% 左右。因此,您只看到了零售去庫存支援的一小部分。關於中國關稅,是的,你是對的。這些數字對這些產品的美學有一定影響。但同樣,這種影響相當小。我們在指導中已經考慮到了這一點。

  • And so I would say, overall, the existing tariffs, you're talking about $30 million approximately globally. And a decent component of that is with respect to the aesthetics business. And then maybe I don't know if Jeff would like to comment on -- I think you had asked if there's -- if we see any demand changes in China?

    所以我想說,總體而言,現有的關稅在全球範圍內約為 3000 萬美元。其中很大一部分與美容行業有關。然後也許我不知道傑夫是否願意評論 - 我想你問過我們是否看到中國的需求有任何變化?

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • No, we haven't over the last 30 days. I mean, obviously, things are -- things change quickly. But as I mentioned, if we look at the -- if we look at the quarter, we've been encouraged by the share growth we've seen in China based on the recent approvals for both the toxin and the filler category.

    沒有,過去 30 天我們沒有這樣做。我的意思是,顯然,事情變化很快。但正如我所提到的,如果我們看一下——如果我們看一下本季度,我們會對中國最近對毒素和填充劑類別的批准所看到的份額增長感到鼓舞。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Trung. Operator, we have time for one final question.

    謝謝,Trung。接線員,我們還有時間回答最後一個問題。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    艾文‧塞格曼 (Evan Seigerman),蒙特婁銀行資本市場。

  • Connor MacKay - Analyst

    Connor MacKay - Analyst

  • Hi there, This is Connor MacKay on for Evan. Congrats on a great quarter. VYALEV and VRAYLAR were two products that outside of your I&I business came in sort of meaningfully ahead of analyst expectations. Can you maybe walk us through what's driving the strength for each of those? Thank you.

    大家好,我是 Connor MacKay,代表 Evan。恭喜本季取得優異成績。VYALEV 和 VRAYLAR 是 I&I 業務之外的兩款產品,其業績遠遠超出了分析師的預期。您能否向我們介紹一下推動這些力量發展的因素?謝謝。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yes, maybe I'll start on your question, and thank you for that. So certainly, as I mentioned in the prepared remarks and Rob as well, VYALEV is emerging as a very, very important product, and we communicated certainly that it could continue to exceed expectations. So it's quite remarkable. We continue to see strong uptake in Japan, across Europe.

    是的,也許我會開始回答你的問題,謝謝你。因此,正如我在準備好的演講中提到的以及 Rob 也提到的那樣,VYALEV 正在成為一種非常非常重要的產品,我們確實表示它可能會繼續超出預期。所以這是非常了不起的。我們繼續看到日本和整個歐洲的強勁成長。

  • And while we're only in the commercial market, which is about 30% of the market in the US because we're still waiting on the full Medicare reimbursement. The market feedback is exceptional. I mean this is a really amazing product to help patients sleep through the night, control on movement disorders. It's unlike Duopa, it lasts for 24 hours. It's a more simple subq injection versus surgery that you might get. So it's playing out exactly as we had hoped.

    雖然我們只處於商業市場,但約占美國市場的 30%,因為我們仍在等待全額醫療保險報銷。市場反饋非常好。我的意思是,這確實是一個令人驚奇的產品,可以幫助患者整夜安睡,並控制運動障礙。它與 Duopa 不同,持續時間為 24 小時。與您可能接受的手術相比,這是一種更簡單的皮下注射。事情正如我們所希望的那樣。

  • And so you're just seeing some strength of that in the quarter. And that's also why we remarked that we're excited to bring tavapadon which is also showing some very nice data here, and we're getting ready for the file to start to really build out a more meaningful Parkinson's category.

    因此,您在本季度看到了一些優勢。這也是為什麼我們說我們很高興帶來 tavapadon,它也在這裡顯示了一些非常好的數據,我們正準備讓文件開始真正建立一個更有意義的帕金森氏症類別。

  • And then alley here, we continue to see uptake, very unique product. Obviously, it's got a 30% approval and overall survival, it's well tolerated, nonchemo. So the US business continues to perform very well, and we are starting to see the interternational launches. We've pulled forward significant international launches from the time that we had done the deal with ImmunoGen, and we're going to start to see those international launches ramp here over the next several quarters. So that gives some sense over that brand as well.

    然後在這裡的小巷裡,我們繼續看到吸收的非常獨特的產品。顯然,它獲得了 30% 的認可度和整體生存率,耐受性良好,無需化療。因此,美國業務持續表現良好,我們也開始看到國際業務的推出。自從我們與 ImmunoGen 達成交易以來,我們就提前進行了重要的國際發布,我們將在接下來的幾個季度中看到這些國際發布活動的加速。這也讓我們對該品牌有了一定的了解。

  • Robert Michael - Chief Executive Officer

    Robert Michael - Chief Executive Officer

  • Colin, this is Rob. I'm glad you asked the question about Elahere because oncology doesn't get enough attention for the company. Elahere came to us through the ImmunoGen acquisition. It was a very successful acquisition. It basically combined their ADC capabilities with our now you're starting to see the AbbVie internally discovered ADCs emerge.

    科林,這是羅布。我很高興你問了 Elahere 的問題,因為腫瘤學並沒有得到公司足​​夠的重視。Elahere 是透過收購 ImmunoGen 而加入我們的。這是一次非常成功的收購。它基本上將他們的 ADC 功能與我們現在開始看到的 AbbVie 內部發現的 ADC 功能結合起來。

  • We've talked about (inaudible). We're very excited about Tmab-A706. You think about long-term growth drivers for AbbVie oncology with that emerging pipeline. And Roopal and I both mentioned 383, the bispecific for multiple myeloma. We have, I think, a very exciting emerging oncology pipeline that could be an important growth driver for the company, so I appreciate the specific question about Elahere.

    我們討論過(聽不清楚)。我們對 Tmab-A706 感到非常興奮。您認為新興產品線將為 AbbVie 腫瘤學帶來長期成長動力。Roopal 和我都提到了 383,一種針對多發性骨髓瘤的雙特異性藥物。我認為,我們擁有非常令人興奮的新興腫瘤學產品線,它可能成為公司的重要成長動力,因此我很感謝你關於 Elahere 的具體問題。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Connor, 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,康納,今天的電話會議到此結束。如果您想收聽電話會議重播,請造訪我們的網站 investors.abbvie.com。再次感謝您的加入。

  • Operator

    Operator

  • Thank you all for joining the AbbVie first-quarter 2025 earnings conference call. That concludes today's conference. Please disconnect at this time, and we hope you have a wonderful rest of your day.

    感謝大家參加 AbbVie 2025 年第一季財報電話會議。今天的會議到此結束。請立即斷開連接,我們希望您今天剩餘的時間過得愉快。