艾伯維 (ABBV) 2026 Q3 法說會逐字稿

內容摘要

  1. 摘要
    • Q3 營收達 174 億美元,年增 10.5%,調整後 EPS 為 3.82 美元,超出指引中值 0.07 美元
    • 再次上調 2026 全年營收與 EPS 指引,全年營收預估提升至 678 億美元,EPS 指引區間上調至 13.95-13.99 美元
    • 宣布自 2027 年 2 月起季度現金股息提高 5.2%;盤後市場反應未特別提及
  2. 成長動能 & 風險
    • 成長動能:
      • SKYRIZI、RINVOQ、VRAYLAR、UBRELVY、QULIPTA、VENCLEXTA 等九大產品皆實現雙位數成長
      • SKYRIZI、RINVOQ 在免疫學領域持續強勁增長,並有新適應症(如 RINVOQ 的 vitiligo、alopecia areata)推動未來成長
      • 神經科學事業群(VRAYLAR、Botox Therapeutic、JUVMO 等)年增 19.5%,新藥 JUVMO(帕金森氏症)已上市,預期帶來長期增長
      • 腫瘤學新藥(etentamig、EPKINLY)臨床數據亮眼,預計 2027 年起成為重要成長催化劑
      • R&D 管線進展順利,Apogee 併購帶來多項差異化資產,SKYRIZI 組合療法、lutikizumab、bretisilocin 等多項新藥推進中
    • 風險:
      • HUMIRA 全球銷售年減 30.6%,受生物相似藥競爭持續衝擊
      • 醫美事業群(JUVÉDERM 等)受經濟不確定性與消費信心低迷影響,銷售下滑 1.8%
      • 340B 政策與 IRA 價格壓力持續,部分產品(如 VRAYLAR、Botox)未來面臨定價與法規不確定性
  3. 核心 KPI / 事業群
    • 免疫學營收:92 億美元,年增 16.6%,SKYRIZI 銷售 58 億美元(+22.9%),RINVOQ 銷售 27 億美元(+24.3%)
    • 神經科學營收:34 億美元,年增 19.5%,VRAYLAR 銷售 11 億美元(+14.3%),Botox Therapeutic 11 億美元(+9.8%),UBRELVY 4.49 億美元(+26.9%),QULIPTA 3.98 億美元(+38%)
    • 腫瘤學營收:17 億美元,年增 0.9%,VENCLEXTA 8.03 億美元(+10.7%),IMBRUVICA 銷售下滑 26.1%
    • 醫美營收:12 億美元,年減 1.8%,Botox Cosmetic 6.69 億美元(+4.1%),JUVÉDERM 2.22 億美元(-11.8%)
    • 調整後毛利率:85.1%,調整後營業利潤率:48.7%
  4. 財務預測
    • 2026 全年營收預估 678 億美元(上調 2 億美元)
    • 2026 調整後毛利率預估超過 84%
    • 2026 調整後 R&D 費用約 98 億美元,SG&A 約 145 億美元
    • Q4 營收預估 184 億美元,調整後 EPS 介於 3.83-3.87 美元
  5. 法人 Q&A
    • Q: 2027 年展望與主要成長動能?RINVOQ 的 payer access 狀況?
      A: 2026 年銷售與獲利成長在同業中排名第二,2027 年預期維持頂尖成長。SKYRIZI、RINVOQ 雖競爭加劇但仍強勁成長,明年有多項催化劑(如 SKYRIZI sub-Q、RINVOQ 新適應症)。神經科學事業群需求強勁,JUVMO 長期貢獻大。RINVOQ 與其他產品在 payer access 上維持強勢,預期低個位數折讓,未來新適應症也將有良好進入。
    • Q: SKYRIZI sub-Q induction 在 Crohn's 的市場機會與市佔動態?SKYRIZI + alpha-4 beta-7 在 IBD 的定位?
      A: SKYRIZI sub-Q 數據優於自家 IV 劑型,特別在治療新手病患。預期 sub-Q 劑型將加速 Crohn's 市佔提升,約 60 天內取得完整市場准入。SKYRIZI + alpha-4 beta-7 組合在早期與後線病患皆展現強效,未來將同時布局 Crohn's 與 UC 早期與後線治療。
    • Q: emraclidine 劑量調整信心來源?有哪些被市場低估的 pipeline 資產?
      A: 150mg 劑量有更佳藥物動力學與受體佔有率,副作用低,預期療效更佳。被低估資產包括 etentamig(多發性骨髓瘤)、Temab-A、神經科學三大 50 億美元以上事業群,以及 zumilokibart 等,長線成長潛力未完全反映在市場預期。
    • Q: 340B 試點參與動機與財務影響?TrenibotE(Boey)醫美新產品進度?
      A: 340B 試點旨在提升透明度與問責,抑制濫用,短期財務影響尚難評估。TrenibotE CRL 原因為 CMC,預計年底補件,明年中美國有望審結,歐洲與加拿大已上市。
    • Q: EPKINLY 在一線大 B 細胞淋巴瘤的競爭力與上市展望?
      A: EPKINLY + R-CHOP 療程簡單、全球熟悉,僅需加入一項新藥,臨床數據強勁,預期全球快速採納。美日等地採利潤分成模式,對營收線有不同影響。

完整原文

使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good morning, and thank you for standing by. Welcome to the AbbVie third-quarter 2026 earnings conference call. (Operator Instructions) Today's call is also being recorded. If you have any objections, you may disconnect at this time.

    早安,感謝各位撥冗等候。歡迎參加 AbbVie 2026 年第三季財報電話會議。(接線員指示)今天的電話會議也將錄音。如有任何異議,您可於此時中斷連線。

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

    現在我想介紹投資人關係資深副總裁 Liz Shea 女士。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Good morning, and thanks for joining us.

    早安,感謝各位加入我們。

  • Also on the call with me today are Rob Michael, Chairman and 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.

    今天與我一同出席電話會議的還有:董事長兼執行長 Rob Michael;執行副總裁兼首席商務長 Jeff Stewart;執行副總裁、研發主管兼首席科學長 Roopal Thakkar;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. AbbVie undertakes no obligation to update these forward-looking statements except as required by law.

    在開始之前,我先說明我們今天所做的部分陳述,可能基於目前的預期而被視為前瞻性陳述。AbbVie 提醒,這些前瞻性陳述存在風險與不確定性,可能導致實際結果與前瞻性陳述所示有重大差異。關於這些風險與不確定性的更多資訊,已載於我們向 SEC 提交的文件中。除法律要求外,AbbVie 不承擔更新這些前瞻性陳述的義務。

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

    在今天的電話會議中,我們將使用非 GAAP 財務衡量指標,以協助投資人了解 AbbVie 的業務表現。這些非 GAAP 財務衡量指標已在我們今日發布的財報新聞稿與監管申報文件中,與可比的 GAAP 財務衡量指標進行調節對照;相關資料可於我們網站查閱。

  • Following our prepared remarks, we'll take your questions.

    在我們的準備發言結束後,將開放提問。

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

    接下來,我把電話交給 Rob。

  • Robert Michael - Chairman of the Board & Chief Executive Officer

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • Thank you, Liz. Good morning, everyone, and thank you for joining us.

    謝謝你,Liz。各位早安,也感謝各位加入我們。

  • AbbVie continues to perform above our expectations, with another quarter of outstanding results. We are delivering top-tier sales and earnings growth and making significant progress advancing our pipeline. Given the strength of our business and our promising outlook, we are once again raising our full-year guidance and increasing our quarterly dividend.

    AbbVie 持續表現優於我們的預期,再度交出一季亮眼成果。我們實現頂尖水準的營收與獲利成長,並在推進研發管線方面取得顯著進展。鑑於我們業務的強勁表現與可期的展望,我們再次上調全年財測指引,並提高季度股利。

  • Turning to our third-quarter performance, we achieved adjusted earnings per share of $3.82, which is $0.07 above our guidance midpoint. Total net revenues were $17.4 billion dollars, beating our expectations by $200 million and reflecting robust sales growth of more than 10%. This includes nine key products that delivered double-digit growth. Based on the strong performance across our business, including SKYRIZI, RINVOQ, VRAYLAR, UBRELVY, QULIPTA, and VENCLEXTA, we are raising our full-year revenue guidance by $200 million and have now raised total revenue by $800 million since the start of the year.

    回到第三季表現,我們達成調整後每股盈餘(EPS)3.82 美元,較指引中位數高出 0.07 美元。總淨營收為 174 億美元,較我們預期高出 2 億美元,反映超過 10% 的強勁銷售成長。其中包含 9 項關鍵產品實現雙位數成長。基於我們整體業務的強勁表現,包括 SKYRIZI、RINVOQ、VRAYLAR、UBRELVY、QULIPTA 與 VENCLEXTA,我們將全年營收指引上調 2 億美元;自年初以來,我們已將總營收上調累計 8 億美元。

  • Further underscoring our confidence in our long-term outlook, today we announced a 5.2% increase in our quarterly cash dividend, beginning with the dividend payable in February 2027. Since inception, we have grown our quarterly dividend by more than 350%.

    為進一步彰顯我們對長期展望的信心,我們今天宣布自 2027 年 2 月可支付的股利起,季度現金股利提高 5.2%。自公司成立以來,我們的季度股利已成長超過 350%。

  • Turning now to R&D, we are making excellent progress advancing our pipeline to help drive growth in the 2030s and beyond. In Immunology, we completed the acquisition of Apogee Therapeutics, adding multiple differentiated assets in dermatology, respiratory, and other related inflammatory diseases with significant sales potential. The lead asset, zumilokibart, will be starting Phase 3 development in atopic dermatitis later this year.

    接著談研發方面,我們在推進研發管線上取得極佳進展,將有助於帶動 2030 年代及更長遠的成長。在免疫學領域,我們已完成收購 Apogee Therapeutics,新增多項具差異化的資產,涵蓋皮膚科、呼吸道及其他相關發炎性疾病,具備可觀的銷售潛力。其領先資產 zumilokibart 預計將於今年稍晚在異位性皮膚炎啟動第三期臨床開發。

  • Also in Immunology, we received US approval for SKYRIZI sub-Q induction in Crohn's. This new dosing option demonstrated exceptional efficacy and further strengthens SKYRIZI's robust growth outlook. We also continue to make substantial progress with our strategy to combine SKYRIZI with complementary mechanisms to further elevate the standard-of-care for patients with IBD. We have now started a large Phase 2-B program in both Crohn's and UC, with SKYRIZI plus our alpha-4 beta-7 ‘382, as well as SKYRIZI plus our TL1A -‘701.

    同樣在免疫學領域,我們取得 SKYRIZI 用於克隆氏症的皮下(sub-Q)誘導治療之美國核准。此一新的給藥選項展現卓越療效,並進一步強化 SKYRIZI 強勁的成長展望。我們也持續在策略上取得重大進展,將 SKYRIZI 與互補機轉結合,以進一步提升 IBD 病患的照護標準。我們現已在克隆氏症與潰瘍性結腸炎(UC)同步啟動大型第二期 B(Phase 2-B)計畫,包含 SKYRIZI 加上我們的 alpha-4 beta-7 ‘382,以及 SKYRIZI 加上我們的 TL1A-‘701。

  • Moving to Neuroscience, we recently expanded our Parkinson's portfolio with the FDA approval of JUVMO. JUVMO provides physicians and patients with a meaningful new treatment option and represents a sizable commercial opportunity for AbbVie. Along with VYALEV and DUOPA, we expect our Parkinson's therapies to collectively deliver peak sales of more than $5 billion dollars.

    再來談神經科學領域,我們近期透過 JUVMO 的 FDA 核准,擴充了帕金森氏症產品組合。JUVMO 為醫師與病患提供具意義的新治療選項,並代表 AbbVie 一項可觀的商業機會。連同 VYALEV 與 DUOPA,我們預期帕金森氏症療法合計可帶來超過 50 億美元的峰值銷售額。

  • We are also making excellent progress with our Oncology pipeline. Etentamig in multiple myeloma has demonstrated very high efficacy, as well as differentiated safety and convenience. We have now submitted our application for etentamig in the US and anticipate approval in 2027. In addition, we reported positive Phase 3 data for EPKINLY in frontline DLBCL and expect regulatory submission next year.

    我們在腫瘤研發管線方面也取得極佳進展。Etentamig 用於多發性骨髓瘤已展現非常高的療效,以及具差異化的安全性與便利性。我們現已在美國提交 etentamig 的申請,並預期於 2027 年獲准。此外,我們公布 EPKINLY 用於一線 DLBCL 的第三期正向數據,並預期於明年進行法規申報。

  • In summary, we are delivering strong execution across our business and see numerous opportunities to drive long-term growth.

    總結而言,我們在各項業務上展現強勁的執行力,並看到多項推動長期成長的機會。

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

    接下來,我把電話交給 Jeff,請他就商業面亮點補充說明。Jeff?

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Thank you, Rob.

    謝謝你,Rob。

  • I'll start with the quarterly results for Immunology, which delivered total revenues approaching $9.2 billion dollars, reflecting operational sales growth of 16.6%. SKYRIZI and RINVOQ continue to exceed our expectations, demonstrating robust growth across all indications.

    我先從免疫學本季表現談起,該業務總營收接近 92 億美元,反映營運層面銷售成長 16.6%。SKYRIZI 與 RINVOQ 持續超越我們的預期,在所有適應症上皆展現強勁成長。

  • SKYRIZI total sales were nearly $5.8 billion dollars, up 22.9% on an operational basis. In psoriasis, SKYRIZI prescription trends remain very strong. Our recent oral competition is not having a substantive impact on our in-play patient share, with SKYRIZI continuing to capture roughly one out of every two new or switching psoriasis patients.

    SKYRIZI 總銷售額接近 58 億美元,以營運基礎計成長 22.9%。在乾癬方面,SKYRIZI 的處方趨勢仍然非常強勁。我們近期的口服競品並未對我們在治療中的病患市占造成實質影響;SKYRIZI 仍持續拿下約每兩位新增或轉換治療的乾癬病患中的一位。

  • We believe that SKYRIZI's best-in-class profile, which delivers 100% skin clearance for the majority of psoriasis patients, high durability of response, very convenient quarterly dosing, exceptional long-term safety, and robust joint protection in psoriatic arthritis with strong data through five years of treatment, sets a very high bar relative to other therapies on the market or in development for psoriasis.

    我們認為 SKYRIZI 的同級最佳(best-in-class)產品特性——包括為多數乾癬病患帶來 100% 皮膚清除率、高反應持久性、非常便利的每季一次給藥、卓越的長期安全性,以及在乾癬性關節炎中具備強勁的關節保護效果(並有長達五年治療數據支持)——相較於市面上或開發中的其他乾癬療法,樹立了非常高的門檻。

  • In IBD, SKYRIZI is growing very robustly as well, and continues to capture half of the new patient starts in the class. And we are very excited to be launching the subcutaneous induction dosing for Crohn's disease, which further strengthens our competitive position. The data supporting this new delivery is striking, including impressive rates of endoscopic response and remission, particularly for CD patients in the frontline setting. This efficacy is clearly differentiated relative to our own SKYRIZI IV formulation, and will allow us to be very competitive versus all induction therapies available for Crohn's today.

    在 IBD 方面,SKYRIZI 也同樣呈現非常強勁的成長,並持續拿下該類別中新病患起始治療的一半。我們也非常期待推出用於克隆氏症的皮下誘導給藥,這將進一步強化我們的競爭地位。支持此一新給藥方式的數據相當亮眼,包括令人印象深刻的內視鏡反應與緩解率,尤其是在一線治療情境下的 CD 病患。相較於我們自家的 SKYRIZI 靜脈注射(IV)劑型,這項療效具明顯差異化,並將使我們在今日可用於克隆氏症的所有誘導治療中保持高度競爭力。

  • Our sub-Q induction regimen is delivered with the same on-body injector as our IBD maintenance dose, which has received very favorable feedback from gastroenterologists and patients both, including overall ease of use, dosing speed, and comfort. While access typically takes a couple months to ramp, our commercial and medical teams have already hit the ground running, and we expect the sub-Q induction will accelerate our new patient share in Crohn's over the next several quarters.

    我們的皮下(sub-Q)誘導療程使用與我們 IBD 維持劑量相同的貼身式注射器(on-body injector)給藥,且已獲得腸胃科醫師與患者的高度正面回饋,包括整體易用性、給藥速度與舒適度。雖然取得用藥可近性通常需要幾個月時間逐步提升,但我們的商業與醫療團隊已迅速展開行動,我們預期皮下誘導將在未來幾個季度加速我們在克隆氏症新患者份額的提升。

  • Overall, we remain very competitively positioned in gastro and psoriatic disease. We are raising our SKYRIZI full-year sales guidance for the third time this year, and we see a substantial opportunity for both market and share growth well into the next decade.

    整體而言,我們在腸胃科與乾癬性疾病領域仍具備非常強的競爭定位。我們今年第三次上調 SKYRIZI 全年銷售指引,並且我們看到在未來十年乃至更久期間,市場規模與市占率成長都存在可觀機會。

  • Turning now to RINVOQ, which delivered global sales of $2.7 billion dollars, reflecting operational growth of 24.3%. RINVOQ is also exceeding our expectations, with particularly strong momentum in both RA and IBD, where we continue to see growing in-play patient share. We are also excited for the indication expansion opportunities in dermatology, with commercialization of RINVOQ for vitiligo and alopecia areata underway already in Europe, and approvals expected for both diseases in the US over the next several months. Recall these two new indications combined are expected to contribute nearly $2 billion of peak sales.

    接著談 RINVOQ,其全球銷售額達 27 億美元,按營運基礎計算成長 24.3%。RINVOQ 也持續超出我們的預期,在 RA 與 IBD 兩個領域動能尤其強勁,我們持續看到正在治療中的患者市占率提升。我們也對皮膚科適應症擴展機會感到振奮,RINVOQ 用於白斑症(vitiligo)與圓形禿(alopecia areata)的商業化已在歐洲展開,且預期未來幾個月內在美國可望取得兩項疾病的核准。請記得,這兩項新適應症合計預期可貢獻接近 20 億美元的峰值銷售額。

  • Lastly, in Immunology, HUMIRA global sales were $683 million dollars, down 30.6% on an operational basis, reflecting continued biosimilar competition.

    最後,在免疫學方面,HUMIRA 全球銷售額為 6.83 億美元,按營運基礎計算下滑 30.6%,反映生物相似藥競爭持續。

  • Moving to Neuroscience, where we continue to outperform expectations across our leading portfolio. Total revenues were nearly $3.4 billion dollars, up 19.5% on an operational basis.

    接著來到神經科學領域,我們在核心產品組合上持續優於預期。總營收接近 34 億美元,按營運基礎計算成長 19.5%。

  • In psychiatry, VRAYLAR global sales were nearly $1.1 billion, up 14.3%. Performance in both bipolar disorder and adjunctive MDD continues to be very strong, reflecting VRAYLAR's well-defined profile in terms of dosing flexibility, low sedation, and the ability to treat a full spectrum of symptoms.

    在精神醫學方面,VRAYLAR 全球銷售額接近 11 億美元,成長 14.3%。在雙相情感障礙與作為重度憂鬱症(MDD)輔助治療的表現持續非常強勁,反映 VRAYLAR 在劑量調整彈性、低嗜睡,以及可治療完整症狀光譜等方面具備明確的產品特性。

  • In migraine, we continue to deliver robust sales growth, driven by share gains and underlying market growth as well. Botox Therapeutic global revenues were approximately $1.1 billion dollars, up 9.8%. UBRELVY global sales were $449 million, up 26.9%, and QULIPTA global revenues were $398 million, up more than 38%.

    在偏頭痛領域,我們持續實現強勁的銷售成長,動能來自市占提升以及底層市場成長。治療用 Botox(Botox Therapeutic)全球營收約 11 億美元,成長 9.8%。UBRELVY 全球銷售額為 4.49 億美元,成長 26.9%;QULIPTA 全球營收為 3.98 億美元,成長超過 38%。

  • Menstrual migraine prevention represents another opportunity to further strengthen our leading CGRP profiles. Recent positive data for QULIPTA and forthcoming results for UBRELVY in this new potential indication could support approval and commercialization in late 2027.

    經期偏頭痛預防代表另一項可進一步強化我們領先 CGRP 產品特性的機會。QULIPTA 近期的正面數據,以及 UBRELVY 在此一潛在新適應症即將公布的結果,可能支持於 2027 年底取得核准並推動商業化。

  • We also have substantial momentum in Parkinson's disease. VYALEV total sales were $286 million, reflecting double-digit growth. We remain on track to exceed $1 billion in revenue this year.

    我們在帕金森氏症方面也具備顯著動能。VYALEV 總銷售額為 2.86 億美元,呈現雙位數成長。我們仍按計畫在今年使營收超過 10 億美元。

  • We are also launching JUVMO, another exciting new treatment for patients with Parkinson's. JUVMO selectively activates the D1/D5 dopamine receptors involved in motor control, and can be prescribed now as both a monotherapy in Parkinson's, as well as an add-on to standard of care. And given JUVMO's distinct profile, including strong durable motor control and low rates of debilitating side effects, such as impulse control disorder, somnolence, and dyskinesia, it represents a sizable commercial opportunity. Sales for JUVMO are expected to ramp gradually over the next several quarters as we work to establish commercial and Medicare coverage, which is expected to be more broadly available starting in 2028.

    我們也正在推出 JUVMO,這是另一項令人振奮、用於帕金森氏症患者的新療法。JUVMO 可選擇性活化與運動控制相關的 D1/D5 多巴胺受體,目前可作為帕金森氏症單一療法處方,也可加用於標準治療。此外,鑑於 JUVMO 具備差異化特性,包括強勁且持久的運動控制,以及較低的致殘性副作用發生率(例如衝動控制障礙、嗜睡與異動症),因此代表相當可觀的商業機會。隨著我們致力於建立商業與 Medicare 給付覆蓋,JUVMO 的銷售預期將在未來幾個季度逐步爬升;預期自 2028 年起可更廣泛取得給付。

  • Turning now to Oncology, total revenues were $1.7 billion, up 0.9% on an operational basis. VENCLEXTA is performing very well, especially in CLL, as combination use with BTK inhibitors is a preferred fixed-duration treatment globally. Total sales were $803 million, up 10.7%. Continued double-digit sales growth from ELAHERE and EPKINLY also helped to offset the expected revenue decline for IMBRUVICA, which was down 26.1% due to IRA pricing and competitive share pressure.

    接著談腫瘤學,總營收為 17 億美元,按營運基礎計算成長 0.9%。VENCLEXTA 表現非常出色,尤其在 CLL,因其與 BTK 抑制劑的合併使用已成為全球偏好的固定療程(fixed-duration)治療。總銷售額為 8.03 億美元,成長 10.7%。ELAHERE 與 EPKINLY 持續的雙位數銷售成長,也有助於抵銷 IMBRUVICA 預期的營收下滑;IMBRUVICA 因 IRA 定價影響與競爭性市占壓力而下滑 26.1%。

  • I am also very excited for our developing portfolio in hematology, following positive data for both etentamig in multiple myeloma and EPKINLY in frontline DLBCL. We anticipate their potential approvals will be an important catalyst for next year and immediately supported by our existing commercial resources, including a substantial heme sales force and medical affairs team.

    我也對我們在血液腫瘤領域的研發產品組合感到非常振奮,因為 etentamig 在多發性骨髓瘤以及 EPKINLY 在一線 DLBCL 的正面數據相繼出爐。我們預期其潛在核准將成為明年的重要催化劑,並可立即由我們既有的商業資源支援,包括規模可觀的血液腫瘤銷售團隊與醫療事務團隊。

  • Lastly, in Aesthetics, global sales were nearly $1.2 billion, down 1.8% on an operational basis. Botox Cosmetic total revenues were $669 million, up 4.1% operationally, reflecting improving market growth globally. JUVÉDERM global sales were $222 million, down 11.8% operationally, reflecting continued headwinds in key dermal filler markets.

    最後,在醫學美容(Aesthetics)方面,全球銷售額接近 12 億美元,按營運基礎計算下滑 1.8%。Botox Cosmetic 總營收為 6.69 億美元,按營運基礎計算成長 4.1%,反映全球市場成長正在改善。JUVÉDERM 全球銷售額為 2.22 億美元,按營運基礎計算下滑 11.8%,反映關鍵皮膚填充劑市場持續面臨逆風。

  • While economic uncertainty and lower consumer confidence have pressured the aesthetics category over the last several quarters, we are starting to see signs of stability. And we think that bringing forward innovation, like our new fast-acting, short-duration toxin, Boey, represents a meaningful opportunity for more new patients to initiate aesthetic treatment. The commercial rollout of Boey is now underway in Europe and Canada, and patient satisfaction has been very high, particularly with the rapid onset, which is consistent with the data from our clinical program.

    儘管經濟不確定性與消費者信心下滑在過去幾個季度對醫美品類造成壓力,我們開始看到穩定的跡象。我們也認為,提前推出創新產品(例如我們新的起效更快、作用時間更短的肉毒毒素 Boey)代表一個有意義的機會,可讓更多新患者開始接受醫美治療。Boey 的商業上市推廣目前已在歐洲與加拿大展開,患者滿意度非常高,尤其是對於快速起效的感受,這也與我們臨床計畫的數據一致。

  • So overall, I am very pleased with the execution and the continued strong performance across our commercial portfolio.

    因此整體而言,我對我們的執行力以及商業產品組合持續強勁的表現感到非常滿意。

  • Now I will turn the call over to Roopal for comments on our R&D highlights. Roopal?

    接下來我將把電話會議交給 Roopal,請她就我們研發(R&D)重點進行說明。Roopal?

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

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

  • Thank you, Jeff.

    謝謝你,Jeff。

  • I will begin with gastroenterology programs in immunology. We further strengthened our leadership position in inflammatory bowel disease with the FDA approval of SKYRIZI subcutaneous induction in Crohn's disease, which was based on the Phase 3 AFFIRM study. Detailed results from this trial were presented at the recent ACG and UEG meetings, demonstrating exceptional results across all clinical and endoscopic measures. We are extremely pleased with SKYRIZI's strong performance, particularly in patients who had not previously experienced advanced therapy.

    我將先從免疫學中的腸胃科計畫開始。基於第三期 AFFIRM 研究結果,FDA 已核准 SKYRIZI 用於克隆氏症的皮下誘導治療,我們也因此進一步鞏固在發炎性腸道疾病領域的領導地位。此試驗的詳細結果已在近期 ACG 與 UEG 會議上發表,顯示在所有臨床與內視鏡指標上皆有卓越成果。我們對 SKYRIZI 的強勁表現感到非常滿意,尤其是在先前未接受過進階治療的患者族群中。

  • In this patient segment, unprecedented results were observed after just 16 weeks of therapy, with 60% endoscopic response, 43% endoscopic remission, and 74% for clinical remission. These results highlight the potential of subcutaneous induction to further enhance SKYRIZI's position in earlier lines of Crohn's disease. Additionally, the SKYRIZI label was updated to provide healthcare providers greater discretion in determining whether tuberculosis evaluation is appropriate prior to treatment initiation, rather than requiring mandatory TB evaluation for all patients.

    在此患者族群中,僅治療 16 週後即觀察到前所未見的結果:內視鏡反應率 60%、內視鏡緩解率 43%,以及臨床緩解率 74%。這些結果凸顯皮下誘導有潛力進一步強化 SKYRIZI 在克隆氏症較早治療線別中的地位。此外,SKYRIZI 的標籤也已更新,讓醫療照護提供者在決定治療開始前是否需要進行結核病(tuberculosis)評估時擁有更大的裁量權,而非要求所有患者都必須強制進行 TB 評估。

  • Also, at the UEG conference, results were presented from the Phase 2 TARGET-CD study evaluating SKYRIZI plus our novel anti-alpha-4 beta-7 antibody, ABBV-382, in Crohn's disease. The combination resulted in a near doubling of endoscopic remission at week 24 compared to either monotherapy.

    另外,在 UEG 會議上也發表了第二期 TARGET-CD 研究結果,該研究評估 SKYRIZI 與我們新型抗 alpha-4 beta-7 抗體 ABBV-382 於克隆氏症的合併治療。與任一單藥治療相比,該合併療法在第 24 週的內視鏡緩解率幾乎倍增。

  • Additionally, gut gene expression data showed a clear improvement from active disease at baseline to early intestinal healing at week 12, followed by broader tissue restoration at week 24. Early changes reflected repair of the intestinal lining and restoration of the gut barrier, effects not observed with monotherapy. By week 24, these changes evolved into signatures associated with tissue repair, nerve recovery, and normalization of metabolic function. We believe this progression from inflammation to healing, and ultimately tissue restoration, may represent an important step toward modifying the underlying disease rather than simply controlling symptoms.

    此外,腸道基因表達數據顯示,從基線時的活動性疾病到第12週的早期腸道癒合有明顯改善,並在第24週進一步出現更廣泛的組織修復。早期變化反映了腸道黏膜修復與腸道屏障功能恢復,而這些效果在單藥治療中未見。至第24週,這些變化進一步演變為與組織修復、神經恢復及代謝功能正常化相關的特徵訊號。我們相信,這種由發炎走向癒合,最終達到組織修復的進程,可能代表朝向改變疾病根本病程的重要一步,而不僅僅是控制症狀。

  • These results support our strategy of combining SKYRIZI with complementary mechanisms to achieve meaningfully higher levels of efficacy in IBD. A large multi-arm Phase 2b trial is underway evaluating SKYRIZI plus 382 and SKYRIZI plus 701, an extended half-life anti-TL1A antibody, in both Crohn's disease and ulcerative colitis. In parallel, co-formulation work is ongoing in preparation for Phase 3 trials.

    這些結果支持我們將 SKYRIZI 與具互補作用機制的療法合併使用,以在 IBD 中達到實質更高療效的策略。目前一項大型多臂第2b期試驗正在進行中,評估 SKYRIZI+382 以及 SKYRIZI+701(一種延長半衰期的抗 TL1A 抗體)在克隆氏症與潰瘍性結腸炎中的表現。同時,為第3期試驗做準備的共同配方(co-formulation)工作也在進行中。

  • Moving to dermatology. Positive top-line results were recently announced from a Phase 3 study evaluating lutikizumab in hidradenitis suppurativa. At week 16, lutikizumab demonstrated statistically significant and clinically meaningful improvements across multiple measures of disease activity. HiSCR-75, which is a rigorous bar for defining clinical response, was achieved by 31% of lutikizumab patients. Lutikizumab also significantly improved skin pain, disease flares, and quality of life measures, with improvement in pain reported as early as week one.

    接著談皮膚科。近期已公布一項評估 lutikizumab 用於化膿性汗腺炎(hidradenitis suppurativa)的第3期研究之正向主要結果。在第16週,lutikizumab 在多項疾病活動度指標上展現具統計顯著性且具臨床意義的改善。HiSCR-75(用於界定臨床反應的嚴格門檻)在 31% 的 lutikizumab 患者中達成。Lutikizumab 亦顯著改善皮膚疼痛、疾病發作(flare)及生活品質指標,且疼痛改善最早在第1週即有回報。

  • HS remains one of the most underserved diseases in dermatology, and these results support lutikizumab's potential to become an important new treatment option for patients with HS. Results from the 36-week blinded extension period will be available next year, with regulatory submissions to follow in the second half of 2027.

    HS 仍是皮膚科中最未被充分滿足需求的疾病之一,而這些結果支持 lutikizumab 有潛力成為 HS 患者重要的新治療選項。36週盲態延伸期的結果將於明年取得,後續預計在 2027 年下半年進行法規申請。

  • Based on these results, we plan to begin an HS platform study later this year to evaluate lutikizumab in combination with our long-acting amylin analog, 295. Other mechanisms, such as anti-TL1A antibody, are also being considered. The Phase 3 program for RINVOQ in HS is also nearing completion, where we remain on track for 16-week top-line results near the end of the year.

    基於這些結果,我們計畫於今年稍晚啟動一項 HS 平台研究,評估 lutikizumab 與我們的長效胺淋(amylin)類似物 295 的合併治療。也正在考慮其他作用機制,例如抗 TL1A 抗體。RINVOQ 用於 HS 的第3期計畫也接近完成,我們仍按進度預期在年底前後取得第16週的主要結果。

  • Moving to atopic dermatitis, zumilokibart Phase 2 results were presented at the EADV Congress, demonstrating rapid and meaningful skin clearance and itch relief. Phase 3 studies are on track to begin later this year.

    在異位性皮膚炎方面,zumilokibart 的第2期結果已於 EADV 大會發表,顯示皮膚清除與止癢效果快速且具臨床意義。第3期研究預計於今年稍晚如期啟動。

  • Turning to Neuroscience, where in the third quarter, JUVMO was approved by the FDA for Parkinson's disease. Dopamine agonists have long been used to help manage symptoms and reduce reliance on oral levodopa escalation. However, currently available agents primarily target D2, D3 receptors, and their use has been limited by adverse events. As a selective D1, D5 receptor agonist, JUVMO demonstrated strong motor control and a favorable tolerability profile, with low rates of dyskinesia, sedation, and impulse control disorder, which have historically impacted the use of dopamine agonists.

    接著談神經科學領域:在第三季,JUVMO 已獲 FDA 核准用於帕金森氏症。多巴胺致效劑長期以來用於協助控制症狀並降低對口服左旋多巴(levodopa)加量的依賴。然而,目前可用藥物主要作用於 D2、D3 受體,其使用常受不良事件所限制。作為選擇性 D1、D5 受體致效劑,JUVMO 展現強勁的運動控制與良好的耐受性特徵,不自主運動(dyskinesia)、嗜睡與衝動控制障礙的發生率偏低;而這些問題過去一直影響多巴胺致效劑的使用。

  • Additionally, long-term data continue to support a reduced reliance on oral levodopa when taking JUVMO. After more than a year and a half on JUVMO, 93% of patients had not increased their levodopa dose, and 94% of patients with early Parkinson's disease had not started oral levodopa. Physicians and patients now have a treatment option that targets dopamine pathways differently and may reduce the difficult trade-offs associated with D2, D3 agonists.

    此外,長期數據持續支持在使用 JUVMO 時可降低對口服左旋多巴的依賴。使用 JUVMO 超過一年半後,93% 的患者未增加其左旋多巴劑量,而 94% 的早期帕金森氏症患者尚未開始使用口服左旋多巴。醫師與患者如今有一種以不同方式作用於多巴胺路徑的治療選項,並可能降低與 D2、D3 致效劑相關的艱難取捨。

  • In psychiatry, the emraclidine dose escalation study has completed. The 150-milligram dose will be utilized in the monotherapy and adjunctive Phase 2 studies in schizophrenia, with enrollment expected to begin by the end of this year. This new dose is 5 times the highest dose evaluated in the previous two pivotal trials. The 150-milligram dose was well-tolerated, and no new safety signals were identified.

    在精神醫學方面,emraclidine 的劑量遞增研究已完成。150 毫克劑量將用於思覺失調症的單藥與加成治療第2期研究,預計於今年底前開始收案。此新劑量為先前兩項關鍵試驗中評估之最高劑量的 5 倍。150 毫克劑量耐受性良好,且未發現新的安全性訊號。

  • We look forward to advancing this higher dose for schizophrenia, which may result in greater efficacy compared to prior studies. Doses have also been selected for the psychosis program, where Phase 2 studies in Alzheimer's and Parkinson's disease are expected to begin early next year.

    我們期待推進此用於思覺失調症的較高劑量,與先前研究相比可能帶來更高療效。同時也已為精神病性症狀(psychosis)計畫選定劑量,預計於明年初啟動阿茲海默症與帕金森氏症的第2期研究。

  • Moving to our psychedelic asset, bretisilocin. A Phase 3 trial evaluating a single-course acute treatment in major depressive disorder is expected to begin later this year. We also remain on track for additional Phase 2 data in monotherapy MDD by year-end, which will help inform the Phase 2 study evaluating repeat dosing for chronic use. This MDD study, as well as Phase 2 proof of concepts in post-traumatic stress, generalized anxiety, and obsessive-compulsive disorders, are expected to begin in 2027.

    接著談我們的迷幻藥資產 bretisilocin。一項評估單一療程急性治療用於重度憂鬱症(MDD)的第3期試驗,預計於今年稍晚開始。我們也仍按進度預計在年底前取得單藥治療 MDD 的更多第2期數據,這將有助於為評估重複給藥、以供慢性使用的第2期研究提供資訊。此 MDD 研究,以及在創傷後壓力症候群、廣泛性焦慮症與強迫症的第2期概念驗證研究,預計於 2027 年開始。

  • In migraine, positive top-line results were announced from the Phase 3 LUNA study, which evaluated QULIPTA for the preventive treatment of menstrual migraine. No medicines are currently approved for menstrual migraine attacks, which are considered more difficult to treat, more disabling, tend to last longer, and have a higher tendency to recur. This underscores the need for effective treatment strategies for this distinct disorder.

    在偏頭痛方面,已公布第3期 LUNA 研究的正向主要結果;該研究評估 QULIPTA 用於經期偏頭痛的預防性治療。目前尚無藥物獲核准用於經期偏頭痛發作;此類發作被認為更難治療、更具失能性、往往持續更久,且更容易復發。這凸顯了針對此一獨特疾病需要有效治療策略。

  • In the LUNA trial, QULIPTA demonstrated meaningful and statistically significant reductions in migraine days associated with the menstrual period, meeting the primary and all eight ranked secondary endpoints versus placebo. A regulatory application will be submitted soon in Europe. Additionally, Phase 3 results for UBRELVY in menstrual migraine prevention are expected near the end of the year, which will potentially support a submission in the US in early 2027.

    在 LUNA 試驗中,QULIPTA 對與經期相關的偏頭痛天數展現具臨床意義且具統計顯著性的降低,相較安慰劑達成主要終點與全部八項排序次要終點。歐洲的法規申請將於近期提交。此外,UBRELVY 用於經期偏頭痛預防的第3期結果預計在年底前後公布,並可能支持於 2027 年初在美國提交申請。

  • Moving to hematologic oncology. Positive top-line results were announced from the Phase 3 CERVINO trial evaluating etentamig monotherapy versus standard of care in heavily pre-treated triple-class exposed multiple myeloma patients. Etentamig delivered statistically significant and clinically meaningful improvements in progression-free survival and overall response rates, with a manageable safety profile, supporting its potential to become an important new treatment option for multiple myeloma.

    接著談血液腫瘤。已公布第3期 CERVINO 試驗的正向主要結果;該試驗評估 etentamig 單藥相較標準治療,用於多線治療後且已暴露於三大類療法(triple-class exposed)的多發性骨髓瘤患者。Etentamig 在無惡化存活期與總反應率方面帶來具統計顯著性且具臨床意義的改善,且安全性特徵可控,支持其有潛力成為多發性骨髓瘤的重要新治療選項。

  • BCMA-directed bispecifics and CAR T therapies have transformed multiple myeloma treatment. However, their adoption, particularly among community-based centers, remains limited by adverse events such as CRS, neurotoxicity, and serious infections, as well as the need for specialized monitoring. With a differentiated safety profile, simplified onboarding, and a more convenient once-monthly dosing schedule after a single step-up dose, etentamig has the potential to streamline treatment and expand access across settings, including community-based clinics. A regulatory application was recently submitted to the FDA, with an approval decision anticipated next year.

    以 BCMA 為標的的雙特異性抗體與 CAR T 療法已改變多發性骨髓瘤的治療。然而,其採用率(特別是在社區型醫療中心)仍受限於細胞激素釋放症候群(CRS)、神經毒性與嚴重感染等不良事件,以及需要專門監測的要求。憑藉差異化的安全性特徵、較簡化的導入流程,以及在一次遞增劑量(step-up dose)後改為每月一次的更便利給藥頻率,etentamig 有潛力簡化治療並擴大不同場域(包括社區診所)的可近性。近期已向 FDA 提交法規申請,預計明年作出核准決定。

  • Beyond the CERVINO program, two new Phase 3 trials were recently initiated for etentamig, one in combination with pomalidomide in second-line plus multiple myeloma, and another as a monotherapy in patients with newly diagnosed light chain amyloidosis. And at the upcoming ASH meeting, early results from a Phase 2 study evaluating etentamig plus daratumumab in frail, transplant-ineligible, frontline multiple myeloma will be presented, with a third Phase 3 study potentially starting next year.

    除 CERVINO 計畫之外,近期亦啟動了兩項針對 etentamig 的第三期臨床試驗:一項是在二線及以上多發性骨髓瘤中與泊馬度胺(pomalidomide)聯合使用,另一項則是在新診斷輕鏈類澱粉沉積症患者中作為單藥治療。此外,在即將召開的 ASH 年會上,將公布一項第二期研究的早期結果,該研究評估 etentamig 聯合 daratumumab 用於體弱、無法接受移植的一線多發性骨髓瘤患者;第三項第三期研究亦可能於明年啟動。

  • Continuing with other heme-onc programs, positive top-line results were announced from the Phase 3 EPCORE DLBCL-2 trial evaluating EPKINLY in combination with R-CHOP in frontline DLBCL. The study demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to R-CHOP alone.

    接著談其他血液腫瘤(heme-onc)計畫:評估 EPKINLY 聯合 R-CHOP 用於一線 DLBCL 的第三期 EPCORE DLBCL-2 試驗公布了正向的主要結果。該研究顯示,相較於單用 R-CHOP,無進展存活期(PFS)有統計上顯著且具臨床意義的改善。

  • EPKINLY plus R-CHOP showed an overwhelming treatment benefit at this interim analysis, reducing the risk of disease progression or death by 51% in a broad population covering patients with international prognostic index scores between 2 and 5. Importantly, this is the first Phase 3 study with a bispecific antibody combination to demonstrate a progression-free survival benefit in frontline supporting the potential for EPKINLY plus R-CHOP to become a new standard of care in this setting. Regulatory submissions are anticipated early next year.

    在本次期中分析中,EPKINLY 聯合 R-CHOP 顯示出壓倒性的治療效益,使疾病進展或死亡風險降低 51%,涵蓋國際預後指數(IPI)分數介於 2 至 5 的廣泛患者族群。重要的是,這是首個以雙特異性抗體聯合療法在一線治療中證實具無進展存活期獲益的第三期研究,支持 EPKINLY 聯合 R-CHOP 有潛力成為此治療情境的新照護標準。預計將於明年初提交監管申請。

  • Turning to solid tumors. At the World Conference on Lung Cancer, results from a Phase 1 study evaluating our PD-1 VEGF bispecific antibody, ABBV-1480, in frontline non-small cell lung cancer were presented. These early data were particularly encouraging given the activity observed in PD-L1 negative patients, a group which has traditionally been more difficult to treat. A Phase 3 study was recently initiated to evaluate 1480 in combination with chemotherapy in frontline squamous and non-squamous non-small cell lung cancer.

    接著談實體腫瘤。在世界肺癌大會上,公布了一項第一期研究結果,該研究評估我們的 PD-1/VEGF 雙特異性抗體 ABBV-1480 用於一線非小細胞肺癌。鑑於在 PD-L1 陰性患者(傳統上較難治療的族群)中觀察到的活性,這些早期數據尤其令人鼓舞。近期已啟動一項第三期研究,評估 1480 聯合化療用於一線鱗狀與非鱗狀非小細胞肺癌。

  • We also intend to move quickly to evaluate ABBV-1480 in combination with our ADCs across several tumor types. Two Phase 2 studies evaluating ABBV-1480 plus Temab-A were recently initiated, one in non-small cell lung cancer and another in colorectal cancer. A Phase 2 combination study with ABBV-706, our SEZ6 ADC, will begin next year in small cell lung cancer.

    我們也計畫迅速推進評估 ABBV-1480 與我們的 ADC 在多種腫瘤類型中的聯合使用。近期已啟動兩項第二期研究,評估 ABBV-1480 聯合 Temab-A:一項在非小細胞肺癌,另一項在大腸直腸癌。與 ABBV-706(我們的 SEZ6 ADC)的第二期聯合研究將於明年在小細胞肺癌中開始。

  • Moving to obesity. Detailed results were presented at EASD from a Phase 1 multiple ascending dose study evaluating ABBV-295 in adults with a mean BMI of less than 30. We continue to be encouraged by the emerging profile for this long-acting amylin analog.

    接著談肥胖。在 EASD 上公布了一項第一期多次遞增劑量研究的詳細結果,該研究評估 ABBV-295 用於平均 BMI 低於 30 的成人。我們持續對這款長效胰淀素(amylin)類似物逐步呈現的特性概況感到鼓舞。

  • In the study, 295 demonstrated meaningful weight loss across multiple dosing regimens, a manageable tolerability profile, and a PK profile that supports potentially differentiating dosing intervals of every other week or monthly. A Phase 1-B study in obese patients is ongoing, with interim data anticipated around the end of this year. Additionally, a Phase 2 trial in obese patients was recently initiated.

    在該研究中,295 在多種給藥方案下展現具意義的體重下降、可管理的耐受性概況,以及支持可能具差異化給藥間隔(每兩週一次或每月一次)的藥物動力學(PK)概況。一項在肥胖患者中的第一期 B(Phase 1-B)研究正在進行中,預計於今年年底前後取得期中數據。此外,近期亦已啟動一項在肥胖患者中的第二期試驗。

  • Turning to Aesthetics. We continue to work closely with the FDA to resolve outstanding matters related to the complete response letter for Boey. Resubmission to the FDA is anticipated before the end of this year, with a regulatory decision expected in mid-2027.

    接著談醫學美容(Aesthetics)。我們持續與 FDA 密切合作,以解決與 Boey 完整回覆函(complete response letter)相關的未決事項。預計在今年年底前向 FDA 重新提交,並預期於 2027 年年中取得監管決定。

  • Additionally, we are exploring a combination of Botox with Boey, which has the potential to deliver differentiated efficacy by combining the rapid onset of Boey with the durable effects of Botox. A Phase 2 study recently began to evaluate this combination in glabellar lines.

    此外,我們正在探索 Botox 與 Boey 的聯合方案,透過結合 Boey 的快速起效與 Botox 的持久效果,有望帶來具差異化的療效。近期已啟動一項第二期研究,以評估此聯合療法用於眉間紋(glabellar lines)。

  • In summary, we continue to make meaningful progress across all stages and therapeutic areas of our pipeline, and look forward to several more important pipeline milestones during the remainder of this year and into 2027.

    總結而言,我們在研發管線的各階段與各治療領域持續取得具意義的進展,並期待在今年剩餘時間以及至 2027 年期間迎來更多重要的管線里程碑。

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

    接下來,我把電話交給 Scott。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • Thank you, Roopal.

    謝謝你,Roopal。

  • Starting with our third quarter results, we reported adjusted earnings per share of $3.82, which is $0.07 above our guidance midpoint. These results include an $0.11 unfavorable impact from acquired IPR&D expense. Total net revenues were $17.4 billion dollars, reflecting robust operational growth of 10.5%, excluding a 0.2% unfavorable impact from foreign exchange.

    先從第三季業績開始,我們公布的調整後每股盈餘為 3.82 美元,較我們指引中點高出 0.07 美元。這些結果包含因併購取得之在製研發(IPR&D)費用帶來的 0.11 美元不利影響。淨營收總額為 174 億美元;若排除外匯帶來的 0.2% 不利影響,反映強勁的營運成長 10.5%。

  • Adjusted gross margin was 85.1% of sales, adjusted R&D expense was 13.9% of sales, and adjusted SG&A expense was 21.2% of sales. The adjusted operating margin was 48.7% of sales, which includes a 1.2% unfavorable impact from acquired IPR&D expense. Adjusted net interest expense was $688 million dollars. The adjusted tax rate was 13.6%.

    調整後毛利率為銷售額的 85.1%,調整後研發費用為銷售額的 13.9%,調整後銷售、一般及行政(SG&A)費用為銷售額的 21.2%。調整後營業利益率為銷售額的 48.7%,其中包含因併購取得之 IPR&D 費用造成的 1.2% 不利影響。調整後淨利息費用為 6.88 億美元。調整後有效稅率為 13.6%。

  • Turning to our financial outlook, we are raising our full-year adjusted earnings per share guidance range by $0.11 at the midpoint to between $13.95 and $13.99. This guidance does not include acquired IPR&D expense that may be incurred beyond the third quarter. We now expect total net revenues of approximately $67.8 billion dollars, an increase of $200 million. At current rates, we continue to expect a roughly 0.5% favorable impact from foreign exchange on full-year sales growth.

    接著談財務展望:我們將全年調整後每股盈餘指引區間的中點上調 0.11 美元至 13.95 至 13.99 美元。此指引未包含第三季之後可能發生的併購取得 IPR&D 費用。我們目前預期淨營收總額約為 678 億美元,上調 2 億美元。以目前匯率計算,我們仍預期外匯將對全年銷售成長帶來約 0.5% 的有利影響。

  • Our revenue forecast now includes the following approximate assumptions for several of our key products and therapeutic areas. For Immunology, we are increasing our global sales outlook to $34.9 billion dollars. This assumes SKYRIZI revenue of $21.8 billion dollars and RINVOQ revenue of $10.3 billion dollars, reflecting increases for both brands based on continued strong momentum. In Neuroscience, we now anticipate global revenues of $13 billion dollars, an increase of $300 million, reflecting VRAYLAR sales of $4.2 billion, Botox Therapeutic sales of $4.2 billion, and total oral CGRP sales of $3.1 billion.

    我們的營收預測目前包含以下對多項關鍵產品與治療領域的大致假設。在免疫學方面,我們將全球銷售展望上調至 349 億美元。此假設 SKYRIZI 營收為 218 億美元、RINVOQ 營收為 103 億美元,反映兩個品牌在持續強勁動能下的上調。在神經科學方面,我們目前預期全球營收為 130 億美元,上調 3 億美元,反映 VRAYLAR 銷售 42 億美元、Botox 治療用途(Botox Therapeutic)銷售 42 億美元,以及口服 CGRP 總銷售 31 億美元。

  • For Oncology, we are raising our global sales guidance to $6.6 billion dollars. This now contemplates higher VENCLEXTA sales of $3.1 billion, as well as lower IMBRUVICA sales of $2.1 billion. In Aesthetics, our global sales outlook remains unchanged at $5 billion dollars and now assumes higher Botox Cosmetic sales of $2.8 billion, offset by lower expected revenues across products in other aesthetics.

    在腫瘤學方面,我們將全球銷售指引上調至 66 億美元。此一預期納入較高的 VENCLEXTA 銷售 31 億美元,以及較低的 IMBRUVICA 銷售 21 億美元。在醫學美容方面,我們的全球銷售展望維持不變,為 50 億美元,並假設 Botox Cosmetic 銷售較高至 28 億美元,但被其他醫美產品預期營收較低所抵銷。

  • Moving to the P&L for 2026, we continue to forecast full-year adjusted gross margin above 84% of sales, adjusted R&D expense of approximately $9.8 billion dollars, and adjusted SG&A expense of approximately $14.5 billion dollars. We also anticipate an adjusted operating margin of approximately 46.7% of sales, which includes a roughly 1.8% unfavorable impact from acquired IPR&D expense incurred through the third quarter.

    接著談 2026 年損益表(P&L):我們仍預測全年調整後毛利率高於銷售額的 84%,調整後研發費用約為 98 億美元,調整後 SG&A 費用約為 145 億美元。我們亦預期調整後營業利益率約為銷售額的 46.7%,其中包含截至第三季所發生之併購取得 IPR&D 費用帶來約 1.8% 的不利影響。

  • Turning to the fourth quarter, we anticipate net revenues of approximately $18.4 billion dollars, which includes a modestly unfavorable impact from foreign exchange. We also forecast adjusted earnings per share between $3.83 and $3.87. This guidance does not include acquired IPR&D expense that may be incurred in the quarter.

    展望第四季,我們預期淨營收約為184億美元,其中包含外匯帶來的輕微不利影響。我們也預估調整後每股盈餘介於3.83至3.87美元之間。此指引未包含本季可能發生的已收購IPR&D(在製研發)費用。

  • Finally, AbbVie's strong business performance continues to support our capital allocation priorities. Our cash balance at the end of September was $10.8 billion dollars, and we generated approximately $14 billion dollars of free cash flow in the first nine months of the year, which includes nearly $2.7 billion dollars of SKYRIZI royalty payments. This robust free cash flow supports a strong and growing quarterly dividend, which we are increasing 5.2% to $1.82 per share, beginning with the dividend payable in February 2027, as well as capacity for additional business development, where we continue to assess external innovation across all of our key growth areas.

    最後,AbbVie強勁的業務表現持續支持我們的資本配置優先事項。截至9月底,我們的現金餘額為108億美元,且今年前九個月我們產生約140億美元的自由現金流,其中包含近27億美元的SKYRIZI權利金收入。這股強勁的自由現金流支持我們穩健且持續成長的季度股利;我們將股利提高5.2%至每股1.82美元,自2027年2月支付的股利起適用;同時也提供額外業務發展的能力,我們持續在所有關鍵成長領域評估外部創新。

  • Following the recent close of the Apogee transaction, we remain on track to achieve a net leverage ratio of 2 times over the next two to three years.

    隨著Apogee交易近期完成交割,我們仍按計畫在未來兩到三年內達成淨槓桿比率2倍的目標。

  • In closing, AbbVie has once again delivered outstanding top and bottom-line results, and our financial outlook remains very strong.

    總結而言,AbbVie再次交出亮眼的營收與獲利表現,我們的財務展望依然非常強勁。

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

    接下來我把電話交回給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. (Event Instructions)

    謝謝,Scott。我們現在開放提問。(活動說明)

  • Operator, we'll take the first question, please.

    接線員,請讓我們進行第一個問題。

  • Operator

    Operator

  • (Operator Instructions) Vamil Divan, Guggenheim Securities.

    (接線員指示) Guggenheim Securities的Vamil Divan。

  • Vamil Divan - Equity Analyst

    Vamil Divan - Equity Analyst

  • Maybe if I could, just as I know you're not getting formal guidance for next year yet, but if I could just ask about, as we think about updating our models today, any sort of key pushes or pulls as we think about next year in terms of dynamics to keep in mind? Also just at this point, anything you can share around payer discussions or RINVOQ and how we should think about?

    或許我可以問一下:我知道你們還沒有提供明年正式指引,但就我們今天要更新模型而言,針對明年的動態,有沒有任何需要留意的關鍵推力或拉力因素?另外,就目前而言,關於付款方(payer)討論或RINVOQ方面,你們有沒有任何可以分享、以及我們應該如何看待的資訊?

  • Robert Michael - Chairman of the Board & Chief Executive Officer

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • Okay. Thanks, Vamil. This is Rob. I'll take the first question, and Jeff will take the second question. As we typically do, we'll provide 2027 guidance on the Q4 call, but we are certainly exiting this year in a very strong position. Our sales and earnings growth in 2026 will be the second highest relative to our peers, and we expect to deliver top-tier growth again next year.

    好的,謝謝你,Vamil。我是Rob。我先回答第一個問題,Jeff會回答第二個問題。如同我們一貫作法,我們會在第四季電話會議提供2027年的指引;不過,我們今年收官時的態勢確實非常強勁。我們2026年的銷售與獲利成長在同業中將是第二高,我們也預期明年再次交出同級領先的成長。

  • When I look at SKYRIZI and RINVOQ, they're delivering incredible growth of $6 billion combined this year, despite already being on the market for eight years and with more competition. If you think about where that growth is coming from, that $6 billion, $3 billion of it is in IBD across RINVOQ and SKYRIZI, with obviously competitive entry in that space. $2 billion of that growth is in SKYRIZI psoriatic, with the competitive entry in that space as well. So we're seeing, despite increased competition, just tremendous growth from SKYRIZI and RINVOQ.

    就SKYRIZI與RINVOQ而言,儘管它們已上市八年且競爭更為激烈,今年兩者合計仍帶來令人驚豔的60億美元成長。若看這60億美元成長的來源,其中30億美元來自RINVOQ與SKYRIZI在IBD(發炎性腸道疾病)領域的表現,而該領域顯然也有競品進入。其中20億美元的成長來自SKYRIZI在乾癬性關節炎(psoriatic)領域,而該領域同樣也有競品進入。因此,即便競爭加劇,我們仍看到SKYRIZI與RINVOQ帶來非常可觀的成長。

  • We have several catalysts that will help drive their growth next year and beyond, including sub-Q induction for SKYRIZI in Crohn's with higher efficacy and more convenient dosing that will give us an even stronger competitive position. We'll see SKYRIZI head-to-head data versus ENTYVIO, which will bolster our position in UC, and we will launch two new derm indications for RINVOQ, both vitiligo and alopecia areata. We have very strong momentum in immunology to continue delivering robust growth next year and beyond.

    我們有數個催化劑可望推動它們在明年及更長期的成長,包括SKYRIZI在克隆氏症(Crohn's)的皮下(sub-Q)誘導治療,具更高療效與更便利的給藥方式,將使我們的競爭地位更為強勢。我們也將看到SKYRIZI與ENTYVIO的頭對頭(head-to-head)數據,這將強化我們在UC(潰瘍性結腸炎)的地位;此外,我們將為RINVOQ推出兩個新的皮膚科適應症,分別是白斑症(vitiligo)與圓形禿(alopecia areata)。我們在免疫學領域動能非常強,將持續在明年及更長期交出強勁成長。

  • Then in neuroscience, we're on track to deliver growth of 20% this year, which has made us the industry leader. I expect the strong demand to continue for VRAYLAR, UBRELVY, QULIPTA, and VYALEV, in addition to Botox Therapeutic. JUVMO, as was mentioned on the call today, it's our new Parkinson's therapy. That will also contribute to the growth, although the ramp will be more significant in '28 and beyond, given timing of Medicare coverage.

    接著在神經科學方面,我們今年可望達成20%的成長,這使我們成為產業領導者。我預期VRAYLAR、UBRELVY、QULIPTA與VYALEV,以及Botox治療性產品(Botox Therapeutic)的強勁需求將持續。如同今天會議中提到的,JUVMO是我們新的帕金森氏症療法。它也將貢獻成長,不過由於Medicare給付時程的關係,較顯著的放量將落在2028年及之後。

  • I would also keep in mind that the IRA price for VRAYLAR will begin in 2027, so you should be modeling that in as well, though I'd say many of the sell-side models have appeared to have modeled that in. Clearly, we have a lot of momentum across our business to drive strong top-tier growth again next year.

    另外也請留意,VRAYLAR的IRA(通膨削減法案)價格將於2027年開始生效,因此你們在建模時也應納入此因素;不過我會說,許多賣方模型看起來已經把這點納入了。很明顯地,我們在各項業務上都有很強的動能,將在明年再次推動強勁、同級領先的成長。

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah. Hi, Vamil. It's Jeff. We are beginning to close all of the arrangements with the large PBMs and payers. And I would say overall, it's a very consistent story as prior years. Our portfolio of products will have very strong access, and it's based on a lot of the demand and the profiles that we have. The physicians really like these products. They're leading products across almost all of our categories, so we anticipate very good payer access.

    是的,嗨,Vamil。我是Jeff。我們正開始完成與大型PBM(藥品福利管理機構)及付款方的所有安排。整體而言,我會說這與往年非常一致。基於我們產品的需求與產品特性,我們的產品組合將享有非常強的可近性(access)。醫師非常喜歡這些產品。它們在我們幾乎所有類別中都是領先產品,因此我們預期將有非常好的付款方可近性。

  • In terms of the immunology approach, that low single-digit sort of rebate concession is something that I would continue to think about in your modeling. Channels move around a bit, but that's typically been our pattern, and we continue to think that that's a good level of guidance there in terms of as we move into 2027 in terms of payer access.

    就免疫學的作法而言,那種低個位數(low single-digit)的回扣讓利(rebate concession)是我建議你在模型中持續納入的假設。通路組合會有些變動,但這通常一直是我們的模式;就付款方可近性而言,當我們邁入2027年時,我們仍認為這是合理的指引水準。

  • And I couldn't fully hear your question, but in terms of RINVOQ, very consistent answer, and we anticipate, with the pending approvals of vitiligo and alopecia areata as we move into '27, that those new indications will also be reflected with favorable access as we move into the new year.

    另外我沒有完全聽清楚你的問題,但就RINVOQ而言,答案非常一致;而且隨著我們在2027年推進白斑症與圓形禿的待核准事項,我們預期這些新適應症在進入新年度時也會反映在有利的可近性上。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Vamil。接線員,請下一題。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    JPMorgan的Chris Schott。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • I just wanted to follow up on the full data from the SKYRIZI sub-Q induction in Crohn's and that recent approval. Can you just help frame out the opportunity here? I guess specifically, how are you thinking about market share dynamics going forward? And I guess how quickly do you think that could play through as you think about just kind of the ramp of SKYRIZI from here?

    我想追問一下SKYRIZI在克隆氏症皮下(sub-Q)誘導治療的完整數據以及近期核准。你們能否協助界定這裡的機會?更具體地說,你們如何看待未來的市占率動態?以及你們認為,從現在起SKYRIZI的放量(ramp)大概會以多快的速度反映出來?

  • My second question was on the pipeline and the role of SKYRIZI and the alpha-4 beta-7 in IBD. Just following the Phase 2 data, are you thinking of this as a drug that's for later lines of therapy or something that could be earlier in the treatment paradigm? Just maybe kind of talk a bit more about how you're seeing that fit relative to SKYRIZI and just other products being developed in the space.

    我的第二個問題是關於研發管線,以及SKYRIZI與alpha-4 beta-7在IBD中的角色。就第二期數據之後,你們是把它視為較後線治療用藥,還是可能更早納入治療策略(treatment paradigm)的選項?也請多談一些你們如何看待它相對於SKYRIZI以及此領域其他開發中產品的定位與契合度。

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah. Hi, Chris. It's Jeff. I'll take the commercial stuff, and maybe Roopal can give a quick flavor over the new data that was announced at ACG and UEGW.

    是的。嗨,Chris。我是Jeff。我先回答商業面的部分,另外也許Roopal可以就ACG和UEGW上公布的新數據做個簡短說明。

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

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

  • Yeah. So on the sub-Q dataset, what you heard from us was very strong data, and when we compare it with our own SKYRIZI IV induction, it's numerically higher and quite substantially higher in that treatment-naive setting, which is the current positioning of SKYRIZI currently in Crohn's and UC. It'll further support that exact positioning, because recall, with RINVOQ having a little bit of a label expansion, that has allowed us, for those patients that are deemed inappropriate for an anti-TNF, who can then use RINVOQ potentially right after SKYRIZI. So that positioning, I should say, has been further substantially strengthened with this subcutaneous offering. So that's one point.

    好的。關於皮下(sub-Q)資料集,你們從我們這裡聽到的是非常強勁的數據;當我們把它與我們自家的SKYRIZI靜脈注射(IV)誘導期數據相比時,數值上更高,而且在治療天真(treatment-naive)的族群中高出相當多——而這正是SKYRIZI目前在克隆氏症與潰瘍性結腸炎(UC)的定位。這將進一步支持同樣的定位;因為請記得,RINVOQ的適應症標籤有些許擴增後,使得對於那些被認為不適合使用抗TNF的病人,可以在SKYRIZI之後很快就可能改用RINVOQ。因此,我應該說,隨著這個皮下給藥選項推出,這樣的定位已被進一步大幅強化。這是第一點。

  • Maybe I'll touch on the alpha-4 beta-7 combo and then go back to Jeff. So Chris, what we saw here was very strong efficacy in later lines, including patients who already used p19s, already used JAK inhibitors like RINVOQ. However, we also saw strong data in earlier lines, and we anticipate being able to see that in Crohn's, and in particular, a lot of excitement from our thought leaders in how this combination can look in earlier lines of ulcerative colitis.

    我可能先談一下alpha-4 beta-7的聯合療法,然後再交回給Jeff。Chris,我們在這裡看到的是在後線治療中非常強的療效,包括已經用過p19類藥物、也已經用過像RINVOQ這類JAK抑制劑的病人。不過,我們也在較前線治療看到強勁數據;我們預期在克隆氏症也能看到這點,特別是在潰瘍性結腸炎的較前線治療中,這種組合可能呈現的樣貌,讓我們的意見領袖非常興奮。

  • Can we get much stronger disease control early in patients rather than waiting for a step-up in care. This can potentially modify the disease, as I was describing, based on gene expression. Could you have much better outcomes in the longer term, reductions in hospital visits and surgeries. So as we move this forward, we would be looking at early patients and in later lines of patients, and that's in Crohn's and UC. We would explore that with 382, which is alpha-4 beta-7, as well as with our TL1A antibody as well.

    我們能否在病人早期就達到更強的疾病控制,而不是等到逐步升階治療(step-up)之後才做到。如我先前根據基因表現所描述的,這可能改變疾病進程。長期而言,你是否能有更好的結果、減少住院就診與手術。因此,當我們推進這項計畫時,我們會同時在早期病人與後線病人中評估,涵蓋克隆氏症與UC。我們會用382(也就是alpha-4 beta-7)以及我們的TL1A抗體來探索。

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah. Chris, in terms of your commercial question, so we are excited about the recent sub-Q approval, and our field teams already are out there promoting this AFFIRM data that's now reflected in the US label. So I think what's important, as Roopal said, these endoscopic endpoints are really resonating for several years now with the gastroenterologists, and that's the single largest market value driver of what preference is.

    是的。Chris,就你問到的商業面而言,我們對近期皮下(sub-Q)核准感到振奮,我們的前線團隊也已經在外推廣這些AFFIRM數據,而這些數據現在已反映在美國標籤上。所以我認為重要的是,如Roopal所說,這些內視鏡終點多年來一直非常能引起腸胃科醫師共鳴,而這也是偏好形成的最大市場價值驅動因素。

  • So when our experts and our IBD experts, our gastros, look at this AFFIRM data, it's quite striking. So it's sort of very high rates, higher than our IV. And when they look, of course, it's cross-study comparisons. When they look across not just IL-23 induction, but every single induction study that's been done to date, it really stands out.

    因此,當我們的專家與IBD專家、腸胃科醫師看到這些AFFIRM數據時,確實相當醒目。也就是說,達到的比率非常高,甚至高於我們的IV。當然,他們看的也是跨研究比較。當他們不只看IL-23誘導期研究,而是看迄今為止做過的每一項誘導期研究時,這些結果確實非常突出。

  • As we've talked about over the last few quarters, the in-play share is roughly 50/50 in IBD versus the main competitor. We would anticipate certainly an acceleration in Crohn's, where we have that approval. Now, in terms of timing as to when we'd see that, it will take us probably 60 days, maybe a little bit longer to get full access. That's just the normal cycle of the approval of something like this with our contracts. So certainly, the first part of the year into the second quarter, we anticipate a pretty rapid share acceleration there.

    如同我們過去幾季談到的,在IBD領域的「進行中(in-play)」市占大約是我們與主要競爭對手各半、約50/50。我們預期在克隆氏症會明顯加速,因為我們已取得該適應症核准。至於何時會看到這個變化,我們可能需要大約60天,或許再久一點,才能取得完整的給付/通路可及性(full access)。這只是像這類核准在合約端的正常週期。因此,在今年前段到第二季,我們預期市占會相當快速地加速提升。

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

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

  • Chris, let me add, we're also very pleased with the updated tuberculosis language that gives physicians more flexibility. So that was important based on years of data. So we're excited about that. Then recall, having the sub-Q option upfront and then having every eight-week dosing, that's another area we can continue to emphasize that makes SKYRIZI so unique.

    Chris,我再補充一下,我們也對更新後的結核病(tuberculosis)用語感到非常滿意,這讓醫師有更大的彈性。基於多年數據,這點很重要。所以我們對此感到興奮。另外請記得,一開始就有皮下(sub-Q)選項,之後又能每8週給藥一次,這也是我們可以持續強調、讓SKYRIZI如此獨特的另一個面向。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝,Chris。接線員,請下一題。

  • Operator

    Operator

  • Louise Chen, Scotiabank.

    Scotiabank的Louise Chen。

  • Louise Chen - Analyst

    Louise Chen - Analyst

  • I wanted to ask you for emraclidine, what gives you confidence that the underdosing was really the issue in the prior studies, and what you're thinking, or related thinking on the market opportunity?

    我想請教關於emraclidine,什麼讓你們有信心認為先前研究的問題確實是劑量不足(underdosing),以及你們對市場機會的想法或相關看法?

  • The other thing I wanted to ask you is that you have a lot of potentially best-in-class assets in your pipeline. Maybe if you could highlight to us which one or which ones you're most excited about that you think are underappreciated by the Street, that would be very helpful.

    另外我想問的是,你們的研發管線裡有很多可能是同類最佳(best-in-class)的資產。如果可以的話,能否請你們指出哪一個或哪些是你們最興奮、且你們認為華爾街(the Street)可能低估的?這會很有幫助。

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

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

  • Hey, Louise. This is Roopal. I'll take that. With emraclidine, we did observe lower receptor occupancy and variability in PK, and again, that's 1/5 of the dose that we're going to take forward at 150 milligram. So the confidence is more around the PK and receptor occupancy and less heterogeneity at the higher dose. So that will drive, hopefully, more predictability there, and we continue to like the benefits of once-a-day dosing and the fact that we don't need another complementary drug to offset adverse events. And thus far, we've seen low GI adverse events. So we think that will be a nice benefit in monotherapy and adjunctive. We are going into Phase 2, so we'll be able to test this out.

    嗨,Louise。我是Roopal。我來回答。就emraclidine而言,我們確實觀察到較低的受體佔有率(receptor occupancy)以及藥物動力學(PK)的變異性;而且再次強調,那只是我們接下來要推進之150毫克劑量的五分之一。因此,我們的信心更多是來自於在較高劑量下,PK與受體佔有率會更好、異質性更低。這將有望帶來更高的可預測性;我們也持續看好每日一次給藥的優勢,以及我們不需要再搭配另一種互補藥物來抵銷不良事件。截至目前,我們看到的腸胃道(GI)不良事件很低。所以我們認為,無論是單藥治療或加成治療(adjunctive),這都會是很好的優勢。我們正要進入第二期(Phase 2),因此將能夠驗證這些假設。

  • So that's, I would say, drug-specific, and then also study-specific. We were able to do deep dives into the EMPOWER studies and our own VRAYLAR studies, and from that, we can learn better approaches to reducing placebo responses. So there's a variety of factors that we're going to implement in all of our trials going forward, and hopefully that will also support favorable outcomes in the future. And if we see that, we would pivot very rapidly to Phase 3.

    所以我會說,這一方面是藥物本身的因素,另一方面也是研究設計層面的因素。我們得以對EMPOWER研究以及我們自家的VRAYLAR研究做深入分析,並從中學到更好的方法來降低安慰劑反應。因此,我們會在未來所有試驗中導入多項因素;希望這也能支持未來出現有利的結果。如果我們看到那樣的訊號,我們會非常迅速地轉進第三期(Phase 3)。

  • Some things that we're excited about, staying in psychiatry, you heard us talk about bretisilocin, MDD is important, but also PTSD, anxiety, and OCD are where we're going to look at Phase 2. So that's potentially underappreciated.

    有些我們感到興奮的項目——仍以精神醫學領域來說——你們聽到我們談到bretisilocin;重度憂鬱症(MDD)很重要,但我們也會在第二期(Phase 2)評估PTSD、焦慮症以及強迫症(OCD)。所以這可能是市場較低估的部分。

  • But I do have to, I would say, mention again, etentamig, and that one is in our pipeline. We have multiple additional Phase 3s that are prepared and ready to go, and this asset is quite near-term, has a potential to launch around the middle of next year, and that is a very exciting asset, as we've described. The CRS rates are very low and almost all Grade 1 and very few Grade 2, and just a single case of ICANS after a single step-up dose, and then you can immediately go to monthly dosing. So this is very well differentiated across anything available currently in the TCE space.

    不過我也必須再次提到etentamig,這個資產在我們的研發管線中。我們已準備好多個額外的第三期(Phase 3)試驗,隨時可以啟動;而且這個資產相當接近近期里程碑,可能在明年年中左右具備上市潛力,正如我們所描述的,這是一個非常令人振奮的資產。CRS發生率非常低,且幾乎都是第1級(Grade 1),第2級(Grade 2)非常少;ICANS也僅有單一案例,且是在一次階梯式加量(step-up)劑量後發生,之後就可以立即改為每月給藥。因此,在目前TCE領域所有可用方案中,這項產品具備非常明顯的差異化。

  • So we're very excited about that one, and we believe that the Street continues to underappreciate that asset and our opportunity in myeloma with etentamig, and then even potentially with our anti-CD38 BCMA T-cell engager trispecific, which we are trying to move very quickly into Phase 3. That's also a very unique opportunity.

    因此我們對這個項目非常振奮,我們相信華爾街仍持續低估該資產,以及我們在多發性骨髓瘤領域透過 etentamig 的機會,甚至也可能包括我們的抗 CD38/BCMA T 細胞接合器三特異性藥物,我們正嘗試非常快速地推進至第 3 期。這同樣是一個非常獨特的機會。

  • Maybe Jeff wants to make a comment.

    也許 Jeff 想補充幾句。

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah. I would agree. We've been surprised, maybe less so more recently, but etentamig is a fantastic profile. Not only will it allow us to enter myeloma, I think, very, very rapidly here, we have multiple drugs behind it. So this is a clear strategy that's underappreciated.

    是的,我同意。我們一直感到驚訝——最近可能沒那麼驚訝了——但 etentamig 的特性非常出色。它不僅能讓我們進入骨髓瘤領域,我認為在這裡我們可以非常、非常快速地推進,而且在它後面我們還有多個藥物。因此,這是一個明確但被低估的策略。

  • I think more recently, because Roopal had such a phenomenal discussion over some of these readouts, very excited about EPKINLY in frontline NHL. This is really the big market value driver in terms of that particular product, and the readout was spectacular.

    我認為最近,因為 Roopal 就其中一些讀出結果進行了非常精彩的討論,我們對 EPKINLY 在一線 NHL 的表現非常興奮。這在該產品的市場價值驅動因素上確實是最大的部分,而讀出結果非常亮眼。

  • I would have to say as well, which is maybe not as big a surprise, but the ability to continue to raise the standard of care in IBD with 466, this combination platform. And we've got multiple shots on goal there with combination TL1A that is very, very close. So the ability to bring multiple assets to basically navigate really the exceptional performance of SKYRIZI as we move into the 2030s is also a profound opportunity for the company.

    我也必須提到,這或許不算太大的驚喜,但我們能夠透過 466 這個組合平台在 IBD 領域持續提高照護標準。而且我們在那裡有多次成功機會,包含非常、非常接近的 TL1A 組合。因此,當我們邁向 2030 年代時,能夠帶來多個資產以因應 SKYRIZI 的卓越表現,對公司而言同樣是深具意義的機會。

  • Robert Michael - Chairman of the Board & Chief Executive Officer

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • Louise, this is Rob, just to add on here. We have mentioned etentamig is a multi-billion dollar opportunity that is significantly undercalled in many street models. I would add Temab-A to that as well, similar, a multi-billion-dollar opportunity, significantly undercalled in many street models. Then, if you look at the neuroscience business, we have said we believe we have three $5 billion-plus franchises covering psychiatry, migraine, and Parkinson's, and we are still not seeing that reflected in longer-term consensus.

    Louise,我是 Rob,補充一下。我們曾提到 etentamig 是一個數十億美元等級的機會,但在許多華爾街模型中被嚴重低估。我也要把 Temab-A 加進來,同樣是數十億美元等級的機會,在許多華爾街模型中也被顯著低估。另外,如果你看神經科學業務,我們說過我們相信我們有三個年銷售額 50 億美元以上的特許經營,涵蓋精神醫學、偏頭痛與帕金森氏症,但我們仍未看到這在較長期的市場共識中反映出來。

  • I would also add zumilokibart as upside to the street versus what we are expecting. As I look at the portfolio we have, as we look at longer-term growth in the 2030s, we have a number of upside opportunities that are not yet reflected in street models.

    我也會把 zumilokibart 視為相較於華爾街預期的上行空間。就我們目前的產品組合來看,當我們展望 2030 年代的長期成長時,我們有多個尚未反映在華爾街模型中的上行機會。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Louise。接線員,請下一個問題。

  • Operator

    Operator

  • Trung Huynh, RBC.

    Trung Huynh,RBC。

  • Trung Huynh - Analyst

    Trung Huynh - Analyst

  • My first question is just on 340B. It has been a persistent challenge for the industry, so it was interesting to see that earlier in this month that you are taking part in this 340B pilot launch for next year. That is for IMBRUVICA, Linzess, and VRAYLAR. Can you just walk us through the strategic rationale for participating there? Are there any potential growth improvements from the reduced duplicate discounts, or do you think we could still expect a headwind from the broader 340B exposure? Just really wondering how material the benefits could be here.

    我的第一個問題是關於 340B。這一直是產業的持續性挑戰,因此本月稍早看到你們將參與明年啟動的 340B 試點計畫很有意思。該計畫涵蓋 IMBRUVICA、Linzess 與 VRAYLAR。你們能否帶我們了解一下參與其中的策略性理由?由於重複折扣降低,是否可能帶來任何成長改善,或者你們認為整體 340B 曝險仍會帶來逆風?我主要想了解這裡的效益可能有多大。

  • Then on aesthetics, could you just give us an update on TrenibotE following the CRL and your just timelines for resubmission? Just how should we think about that?

    另外在醫美方面,能否就 TrenibotE 在收到 CRL 之後提供最新進展,以及你們重新提交的時間表?我們應該如何看待這件事?

  • Robert Michael - Chairman of the Board & Chief Executive Officer

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • This is Rob. I will take your first question on 340B. Yes, we are very focused on curbing the abuse in the program, and we are very supportive of the original intent of the program, which was to help safety net hospitals serve the most vulnerable populations. Unfortunately, today we have an outdated and overly broad definition of a 340B patient, which has led to significant program abuse. That ultimately drives higher healthcare costs for employers, taxpayers, and patients, and it takes R&D investment away from the industry.

    我是 Rob。我先回答你關於 340B 的第一個問題。是的,我們非常專注於遏止該計畫中的濫用行為,同時我們也非常支持該計畫的初衷,也就是協助安全網醫院為最弱勢族群提供服務。不幸的是,現今對 340B 病患的定義已過時且過於寬泛,導致計畫被大量濫用。這最終推升雇主、納稅人與病患的醫療成本,並且使產業的研發投資被挪走。

  • That said, we are encouraged by the bipartisan support we are seeing across both the House and Senate on a few proposals that can bring greater transparency and accountability. And that is really what it is about. It is about driving more transparency and accountability, which is also what I believe this rebate pilot will accomplish. It is another opportunity to provide that transparency to ensure that this program ultimately serves its original intent to benefit patients and not steal investment away from R&D.

    話雖如此,我們對目前在眾議院與參議院看到的兩黨支持感到鼓舞,因為有幾項提案可以帶來更高的透明度與問責。而這正是重點所在。重點在於推動更高的透明度與問責,我也相信這個回饋金試點將能達成。這是另一個提供透明度的機會,以確保該計畫最終能回到其原始目的——讓病患受益,而不是把投資從研發中抽走。

  • I think it is too early to call a financial impact. We will have to see how this plays out. We certainly manage the duplicate discounts well. We have good visibility to that, so I would say we have been managing through it. There has been, though, profound growth in this program that I think the entire industry has been seeing, which is why we are advocating for policies that curb the abuse that we are seeing.

    我認為現在要判斷財務影響還太早。我們必須看看後續如何發展。我們確實把重複折扣管理得很好。我們對此有良好的可視性,所以我會說我們一直在妥善應對。不過,這個計畫的成長確實非常顯著,我想整個產業都看到了,這也是為什麼我們倡議能遏止我們所見濫用情況的政策。

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

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

  • It is Roopal on the TrenibotE question. Recall that the CRL was not due to any particular issues around safety or efficacy. It was on CMC assessments, and we are gathering that data for the agency, and we will resubmit at the end of this year, and we anticipate a six-month review, so we think the middle of next year in the US. And while this is ongoing, we are also submitting in other countries across the globe. We already have European approval and as well as Canada.

    我是 Roopal,回答 TrenibotE 的問題。請記得,CRL 並不是因為任何特定的安全性或有效性問題。它是針對 CMC 評估,我們正在為主管機關蒐集相關資料,並將在今年底重新提交;我們預期審查期為六個月,因此我們認為在美國大約是明年年中。同時在此進行期間,我們也正在全球其他國家提交申請。我們已經取得歐洲核准,也取得加拿大核准。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Trung。接線員,請下一個問題。

  • Operator

    Operator

  • Jason Gerberry, Bank of America.

    Jason Gerberry,美國銀行。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Mine was just on 466, and if you could talk about, are there any triggers to potentially move this into Phase 3 faster? I know you have the interim data for the Phase 2b with the higher dose integrin. Imagine that's something that you're curious to see the results from before going to Phase 3, but wondering to the extent that you might be rate limited just by the co-formulation work, and that's put the hard and fast kind of 2028 start on the Phase 3 program.

    我的問題是關於 466。你們能否談談,是否有任何觸發因素可能讓你們更快把它推進到第 3 期?我知道你們有第 2b 期、較高劑量 integrin 的期中數據。我想那可能是你們在進入第 3 期前很想看到的結果,但我也想了解,在多大程度上你們可能會受到共同配方(co-formulation)工作的限制,因而把第 3 期計畫的啟動時間硬性定在 2028 年。

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

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

  • Hey, Jason. It's Roopal. So we do have built-in interims in this next dataset that's going forward. A few things that we're going to do to assess the 382 exposure response. One thing to help speed things up is look at the data and run assays more often than you typically would and not waiting for the end.

    嗨,Jason。我是 Roopal。因此,我們在接下來要推進的這組資料中確實內建了期中分析。我們會做幾件事來評估 382 的暴露量—反應關係。其中一個加速方式,是更頻繁地查看數據並執行檢測(assays),而不是等到最後才做。

  • The other thing we will also see is for the Phase 2 study that we were just talking about here today, we've shown about 80% of the data. We'll get 100% of that data by the end of this year, early next year, and that'll let us rerun some of these models and to see if we continue to observe that exposure response lack of plateau for 382. Sometimes with greater sample size, you could see things move in either direction. While that's occurring, we'll start generating more data on the combo.

    另外,我們也會看到:就我們今天剛談到的第 2 期研究而言,我們已經展示了大約 80% 的數據。我們將在今年底、明年初取得 100% 的數據,這將讓我們重新跑一些模型,看看我們是否仍持續觀察到 382 的暴露量—反應關係沒有出現平台期。有時候樣本數增加後,你可能會看到結果往任一方向變動。在此同時,我們也會開始產生更多關於組合療法的數據。

  • If something is looking good, then we can speed up the trial in a way by dropping the arm that's the current standard dose. Alternatively, if we are seeing that the efficacy is shouldering at a particular dose, then we don't have to continue the high dose, and then we can pivot to the standard dose that we've already studied, gather some more data there, be ready for regulators, and then potentially move into Phase 3 sooner.

    如果某些結果看起來不錯,那麼我們可以透過取消目前標準劑量的治療組,以某種方式加快試驗進度。或者,如果我們看到療效在某個劑量出現平台期,那麼我們就不必繼續高劑量,接著可以轉向我們已經研究過的標準劑量,在那裡再收集更多數據,為監管機關做好準備,並且可能更早進入第三期。

  • It's hard to commit now. I would say there is some potential that we could start Phase 3s at the end of 2027. We'll come back to see if that's possible, but I haven't ruled that out based on our ability to look at the data on an interim basis.

    現在很難做出承諾。我會說,我們確實有一些可能性在2027年底啟動第三期試驗。我們會再回頭評估這是否可行,但基於我們能夠以期中方式檢視數據的能力,我並沒有把這個可能性排除。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Jason.

    謝謝你,Jason。

  • Operator

    Operator

  • Simon Baker, Rothschild & Co, Redburn.

    Simon Baker,Rothschild & Co,Redburn。

  • Unidentified Participant

    Unidentified Participant

  • This is [Keith] for Simon Baker. I have a quick question on EPKINLY in first-line large B-cell lymphoma. So given your competitors developing a different combination regimen, any thoughts about the competitiveness of EPKINLY-based regimen? Maybe just a quick follow-up on EPKINLY as well. How should we think about the launch trajectory of EPKINLY in first-line large B-cell lymphoma?

    我是[Keith],代替Simon Baker提問。我有一個關於EPKINLY在一線大型B細胞淋巴瘤的簡短問題。鑑於競品正在開發不同的聯合用藥方案,你們對以EPKINLY為基礎的方案競爭力有何看法?另外也想就EPKINLY再追問一下。我們應該如何看待EPKINLY在一線大型B細胞淋巴瘤的上市推進軌跡?

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

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

  • Maybe I'll start, and then Jeff will comment. What we like about the approach with EPKINLY with R-CHOP is that R-CHOP is very familiar, it's very well-known across the globe, and there's a simplicity of just adding EPKINLY to a very well-known treatment regimen. So we think there's already a benefit there.

    也許我先回答,然後Jeff再補充。我們喜歡EPKINLY搭配R-CHOP這個策略的原因是,R-CHOP非常熟悉、在全球也非常廣為人知,而且只是在一個眾所周知的治療方案上加上EPKINLY,做法很簡單。因此我們認為這本身就已經有優勢。

  • Then you also don't have to add two novel agents to a regimen. This would just be a single novel to R-CHOP that people understand very well. So from an R&D standpoint, we're excited about that, and that's what we hear from clinicians, that for them, it'll be relatively a simple approach.

    此外,你也不需要在方案中加入兩個新型藥物。這只是把單一新型藥物加入到大家非常了解的R-CHOP。所以從研發角度來看,我們對此感到很振奮;而且我們從臨床醫師那裡聽到的回饋是,對他們而言,這會是一個相對簡單的做法。

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah, and I think that, as I mentioned, that frontline potential is clearly the largest commercial opportunity. We had always known that that was a larger commercial opportunity with our partner, Genmab, but to see the strength of the data, it's quite striking. We do believe, despite what we may see from the competitor readout, that this is a very, very simple approach. It's going to play extremely well around the world because there's a variability over countries on how they view POLIVY, the reimbursement of POLIVY.

    是的,而且我認為,正如我提到的,一線治療的潛力顯然是最大的商業機會。我們一直都知道,與合作夥伴Genmab一起推進時,這是一個更大的商業機會;但看到數據的強度,確實相當令人印象深刻。我們確實相信,儘管我們可能會看到競品的讀出結果,這仍是一個非常、非常簡單的做法。它在全球各地會非常吃香,因為各國對POLIVY的看法以及POLIVY的給付/報銷存在差異。

  • Again, you have two novel novels, it starts to build up the cost. So the exquisite simplicity of what we've done in frontline with EPKINLY has resonated very much with the thought leaders around the world, and I think it will resonate very rapidly with the HTAs and other payers. And so we anticipate, as we move towards approvals, as Roopal mentioned, we will be moving quickly with the regulatory filings here. I would expect quite a rapid adoption of that transformational indication.

    再者,如果你有兩個新型藥物,成本就會開始堆疊上去。因此,我們在一線治療中以EPKINLY所做的這種極致簡潔性,已經非常打動全球的意見領袖;我認為它也會很快打動HTA機構與其他支付方。所以我們預期,隨著我們朝核准邁進,正如Roopal所提到的,我們會在此快速推進監管申報。我預期這個具變革性的適應症會被相當快速地採用。

  • Scott Reents - Executive Vice President, Chief Financial Officer

    Scott Reents - Executive Vice President, Chief Financial Officer

  • This is Scott. I would just make sure everyone recalls that with respect to that product and the partnership that we have with Genmab, there is partnership economics, so we are not booking sales, the full sales in the US, Puerto Rico, and Japan. We are booking a profit share, so it is a little bit of a different impact on the revenue line.

    我是Scott。我只是想提醒大家,關於該產品以及我們與Genmab的合作夥伴關係,存在合作的經濟分配機制,因此我們在美國、波多黎各與日本並不是認列全部銷售額。我們認列的是利潤分成,所以對營收線的影響會有些不同。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thank you for the question. Operator, next question, please.

    謝謝你的提問。接線員,請下一題。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    Terence Flynn,摩根士丹利。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Maybe a two-part for me. I guess, Rob, now that you've integrated Apogee, could you just provide your latest perspective on M&A and business development appetite and how you're thinking about size of potential deals from here?

    我這邊可能有兩個部分。我想,Rob,在你們整合Apogee之後,你能否分享一下你們對併購(M&A)與業務開發(BD)意願的最新看法,以及你們接下來如何思考潛在交易的規模?

  • Then relatedly, on obesity, a question we get a lot is, does AbbVie need a GLP-1 to be able to compete at scale in this market? Obviously, you have the amylin. You talked about an interesting combination approach today. But how do you think about need for a GLP-1?

    另外,關於肥胖症,我們常被問到的一個問題是:AbbVie是否需要GLP-1,才能在這個市場以規模化方式競爭?顯然你們有amylin。你們今天也談到一個有趣的聯合用藥策略。但你們如何看待對GLP-1的需求?

  • Robert Michael - Chairman of the Board & Chief Executive Officer

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • Thanks, Terence. I'll take the first question, and Roopal will take the second one. I would point to the Apogee deal and really the PD-1/VEGF from RemeGen as great examples of the BD priorities that we've been communicating for a while now.

    謝謝你,Terence。我先回答第一個問題,第二個由Roopal回答。我會指出Apogee這筆交易,以及來自RemeGen的PD-1/VEGF,都是我們一段時間以來一直在對外溝通的BD優先事項的很好例子。

  • Our focus really continues to be on differentiated assets in our core areas, immunology, neuroscience, and oncology. But we're also looking to expand in obesity as well. I'd say, across the portfolio, it could be an early-stage deal, late stage, or even on market. Again, given that our existing products and pipeline give us a clear line of sight to strong, durable growth into the 2030s, we have ample financial capacity to pursue the deals we're interested in.

    我們的重點確實仍然放在核心領域中具差異化的資產:免疫學、神經科學與腫瘤學。但我們也在尋求擴展到肥胖症領域。我會說,就整體產品組合而言,可能是早期交易、後期交易,甚至是已上市產品。同樣地,鑑於我們現有產品與研發管線讓我們清楚看到可延續到2030年代的強勁且持久成長,我們有充足的財務能力去追求我們感興趣的交易。

  • Now, I would expect these to be more bolt-on additions versus a large transformational deal like Allergan, and that's because our business already has good breadth. For us, it's really more about adding further depth to these areas to drive that long-term growth.

    我預期這些會更偏向補強型(bolt-on)的併入,而不是像Allergan那樣的大型變革性交易,因為我們的業務本身已經具有良好的廣度。對我們而言,更重要的是在這些領域增加更深的厚度,以推動長期成長。

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

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

  • Yeah, and it's Roopal. Yeah, we continue to have interest to build out obesity assets. We are open to anything that has a profile that's differentiated that could match potentially our 295, especially when it comes to a co-formulation. That could be incretin class or anything else. And we want to continue to drive efficacy, but very importantly, tolerability, because patients still continue to start and stop and spin off.

    是的,我是Roopal。是的,我們仍然有興趣擴充肥胖症資產。我們對任何具差異化特徵、且可能與我們的295相匹配的項目都持開放態度,特別是在共同配方(co-formulation)方面。這可以是腸泌素(incretin)類別或其他任何類別。我們希望持續提升療效,但同樣非常重要的是耐受性,因為病人仍然會持續出現開始用藥、停藥、以及中途流失的情況。

  • If we had other combo agents that continues to open the door in other indications that we already have leadership in, psoriasis, psoriatic arthritis. I already mentioned HS with an amylin, but if we had another agent, you could imagine us going into HS.

    如果我們有其他聯合用藥的藥物,這也會為我們在其他適應症打開大門,而那些適應症我們本來就具領導地位,例如乾癬、乾癬性關節炎。我已經提到以amylin用於HS(化膿性汗腺炎),但如果我們還有另一個藥物,你可以想像我們會進一步切入HS。

  • Just for context, the mean BMI of our study with lutikizumab was almost 34. So on average, it already fits a category where one could anticipate either amylin use in the future or incretin use today.

    補充一下背景資訊:我們lutikizumab研究的平均BMI接近34。因此平均而言,它已經符合一個類別,在未來可以預期使用amylin,或是在今天使用腸泌素類藥物。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Terence。接線員,請下一題。

  • Operator

    Operator

  • Steve Scala, TD Cowan.

    Steve Scala,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • I have two questions. Can you help us create an expectation for the RINVOQ efficacy readout in HS, specifically on HiSCR50 placebo-adjusted benefit? Should we be thinking about something closer to 10% or 25%? That's the first question.

    我有兩個問題。你們能否協助我們建立對RINVOQ在HS中的療效讀出預期,特別是HiSCR50在扣除安慰劑後的效益?我們應該把它想成更接近10%還是25%?這是第一個問題。

  • Second question is, what should be our expectation for Botox IRA pricing, both in percentage as well as issues revolving around the litigation? Presumably, AbbVie already knows the discount, so what can you tell us?

    第二個問題是,對於 Botox 在 IRA 下的定價,我們應該有什麼樣的預期——不論是百分比幅度,還是與訴訟相關的議題?推測 AbbVie 已經知道折扣幅度,所以你們能告訴我們什麼?

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

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

  • Hey, Steve, it's Roopal. For HS and RINVOQ, we still anticipate the readout later this year, and as you mentioned, the primary endpoint is HiSCR50. I would say it's difficult to know what the exact delta could be. We do see that drift in placebo. We observed it ourselves with lutikizumab. That's probably driven by heterogeneity, larger patient populations, more sites, more countries. It's difficult to know until we see the Phase 3 data.

    嗨,Steve,我是 Roopal。就 HS 與 RINVOQ 而言,我們仍預期今年稍晚會有讀出;如你所提到,主要終點是 HiSCR50。我會說,很難知道確切的差異(delta)會是多少。我們確實看到安慰劑組有漂移。我們在 lutikizumab 上也親自觀察到這點。這可能是由異質性、更大的病人族群、更多試驗中心、更多國家所驅動。在看到第三期數據之前,很難下定論。

  • The way we think about it is that HiSCR is just one parameter, and really, the key driver, the number one symptoms that patients have and that clinicians also reiterate is pain. What we saw with luti has us very encouraged because the pain started to -- patients had relief from pain as early as week one over the course of therapy. Quality of life is also important. Lack of flares is very important. And these are the things that we would look to in the RINVOQ study as well. It'll come down to totality of data and what are these key drivers for patients and for clinicians.

    我們的看法是,HiSCR 只是其中一個參數;真正的關鍵驅動因素、病人最主要的症狀,也是臨床醫師一再強調的,是疼痛。我們在 luti 看到的結果讓我們非常受鼓舞,因為在治療過程中,病人的疼痛緩解最早在第一週就開始出現。生活品質也很重要。沒有復發(flares)也非常重要。這些也都是我們在 RINVOQ 研究中會關注的面向。最終會取決於整體數據的全貌,以及哪些是對病人與臨床醫師而言的關鍵驅動因素。

  • What I can say is we will be capturing this evidence in the RINVOQ study, just as we did in the lutikizumab study. And what RINVOQ brings is an oral, and recall that it's also coming in as a second line post other advanced therapies like other biologics. So the setup there and the positioning is consistent with PSA, Crohn's, and UC, where we have a biologic today, it's SKYRIZI, that goes into more frontline earlier patients, and then RINVOQ comes in later. Same thing could develop here with lutikizumab going early and then RINVOQ coming in later.

    我可以說的是,我們會在 RINVOQ 研究中蒐集這些證據,就像我們在 lutikizumab 研究中所做的一樣。而 RINVOQ 的特點是口服;並且請記得,它也會以第二線治療的定位切入,也就是在其他進階療法(例如其他生物製劑)之後使用。因此,這樣的設計與定位,與 PSA、克隆氏症以及 UC 的情況一致:我們目前有一個生物製劑 SKYRIZI,會更偏向前線、較早期的病人;接著 RINVOQ 會在後線進入。同樣的模式也可能在這裡形成:lutikizumab 先在前線使用,之後 RINVOQ 再於後線切入。

  • Robert Michael - Chairman of the Board & Chief Executive Officer

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • Steve, this is Rob. I'll take your question on Botox IRA. Look, we feel the IRA is very clear that products derived from human blood or plasma are not eligible for selection. One of Botox's three ingredients is human serum albumin, which is a protein extracted from human blood plasma.

    Steve,我是 Rob。我來回答你關於 Botox IRA 的問題。你看,我們認為 IRA 的規定非常清楚:源自人類血液或血漿的產品不符合被選定(selection)的資格。Botox 的三種成分之一是人血清白蛋白(human serum albumin),這是一種從人類血漿中萃取的蛋白質。

  • Botox has 100,000 times more human serum albumin than toxin, which is why we believe Botox is not eligible for selection under the IRA. A federal district court just yesterday ruled in our favor. Now that ruling is subject to appeal by the government, so we'll have to wait to see if there are any more proceedings. But in the meantime, we would not expect a price to be published while this plays out.

    Botox 中的人血清白蛋白含量是毒素的 100,000 倍,這也是我們認為 Botox 在 IRA 下不符合被選定資格的原因。聯邦地方法院就在昨天裁定我們勝訴。當然,該裁定仍可能被政府上訴,因此我們必須等待是否會有後續程序。但在此期間,我們不預期在此事尚未明朗前會公布價格。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Steve。接線員,請下一題。

  • Operator

    Operator

  • Dave Risinger, Leerink Partners.

    Leerink Partners 的 Dave Risinger。

  • David Risinger - Analyst

    David Risinger - Analyst

  • I have a question for Roopal, please. Roopal, can you just talk about I&I pipeline candidate trial results to watch in 2027 after the RINVOQ HS results in coming months?

    我想請教 Roopal 一個問題。Roopal,你能談談在未來幾個月 RINVOQ HS 結果出來之後,2027 年有哪些 I&I 研發管線候選藥物的試驗結果值得關注嗎?

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

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

  • Hey, thanks. It's Roopal here. I would say after we see this dataset, that's the RINVOQ HS, we're going to be keeping a close eye on the IBD combos. And as I stated before, we'd be looking for interim data to see if we can accelerate even further.

    嗨,謝謝。我是 Roopal。我會說,在我們看到這個資料集(也就是 RINVOQ HS)之後,我們會密切關注 IBD 的聯合療法(combos)。而且如我先前所說,我們會尋找期中數據,看看是否能進一步加速。

  • The other important outcome next year is RINVOQ in lupus. So I would be looking for that. Then we can anticipate, hopefully, some data out of our B-cell depletion portfolio that includes a CD19 depleting antibody, the CD19 with an ADC, and of course, our in vivo CAR T against CD19. So we're starting to see some patients starting to enroll post the first in human in healthies. That could be other very important data sets that we would see next year.

    明年另一個重要的結果是 RINVOQ 在狼瘡上的數據。所以我會關注那個。接著,我們也可以期待(希望)從我們的 B 細胞耗竭(B-cell depletion)產品組合中看到一些數據,其中包括一個 CD19 耗竭抗體、CD19 的 ADC,以及當然還有我們針對 CD19 的體內(in vivo)CAR T。我們在健康受試者的首次人體試驗之後,已開始看到一些病人開始入組。這些都可能是我們明年會看到的其他非常重要的資料集。

  • Other readouts potentially are in rheumatoid arthritis, combos with luti and psoriatic arthritis as well. I would say, not necessarily readout, but we are going to be kicking off plenty of studies post the Apogee acquisition. And you will see the Phase 3 study starts with Zumi in atopic dermatitis.

    其他可能的讀出還包括類風濕性關節炎(rheumatoid arthritis),luti 的聯合療法,以及乾癬性關節炎(psoriatic arthritis)。我會說,不一定是讀出,但在完成 Apogee 併購之後,我們將啟動大量研究。你們也會看到 Zumi 在異位性皮膚炎(atopic dermatitis)的第三期研究啟動。

  • We are also going to be doing either Phase 2-B work quickly, I would say, and then moving into Phase 3 for pruritus, urticaria, prurigo nodularis, and then combination work with the TSLP in EoE, asthma, COPD, sinusitis. Then imagining as those move forward, eight distinct Phase 3 programs that would be reading out in late '29 across into the mid-2030s. So quite a bit to keep an eye on in immunology.

    我們也會很快進行第二期 B(Phase 2-B)的工作,然後推進到第三期,用於搔癢(pruritus)、蕁麻疹(urticaria)、結節性癢疹(prurigo nodularis);另外也會在嗜酸性食道炎(EoE)、氣喘、COPD、鼻竇炎(sinusitis)等適應症上,進行與 TSLP 的聯合研究。接著可以想像,隨著這些計畫推進,將會有 8 個不同的第三期計畫在 2029 年下半年開始讀出,並延伸到 2030 年代中期。因此在免疫學領域有相當多值得關注的進展。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Dave。接線員,請下一題。

  • Operator

    Operator

  • Mohit Bonsal, Wells Fargo.

    Wells Fargo 的 Mohit Bonsal。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Just wanted to touch upon tavapadon a little bit. It does seem like in the trials you have done, longer-term data suggest that the drug was able to spare patients from levodopa for a long time. So would love to understand how you are thinking about positioning this drug. I mean, you have a $5 billion guidance for the entire Parkinson's franchise, and tavapadon is a smaller part of this. What could be a surprise for us from the upside point of view? Where are you positioning it, and what is the feedback you are getting so far from the physicians as you are launching this product?

    我想稍微談一下 tavapadon。看起來在你們做過的試驗中,較長期的數據顯示,這個藥能讓病人很長一段時間不需要使用左旋多巴(levodopa)。所以我很想了解你們如何思考這個藥的定位。我的意思是,你們對整個帕金森氏症產品線給出的指引是 50 億美元,而 tavapadon 只是其中較小的一部分。從上行角度來看,對我們而言可能有哪些驚喜?你們把它定位在哪裡?以及在你們推出這個產品的過程中,目前從醫師那邊得到什麼回饋?

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

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

  • Yeah. Mohit, it's Roopal. I'll make a few comments, and then Jeff can speak about the opportunity here. Yeah, you caught onto something very interesting, and that's what our experts are quite excited about, that if you're an early patient and you start taking tavapadon, very rarely will you need, and this is, I think, around 85 weeks or so, that you would need to start levodopa-carbidopa. Many clinicians are interested in keeping that in pocket as long as possible due to the adverse events that can happen later.

    是的。Mohit,我是 Roopal。我先做幾點評論,然後 Jeff 可以談談這裡的機會。你抓到了一個非常有趣的點,也是我們的專家相當興奮的地方:如果你是早期病人並開始服用 tavapadon,在很長一段時間內你很少需要開始使用左旋多巴-卡比多巴(levodopa-carbidopa)——我想大約是 85 週左右。許多臨床醫師有興趣盡可能把那個選項留在口袋裡,因為後期可能會出現不良事件。

  • We saw that same thing plays out in a little different format on patients that were currently on levodopa-carbidopa. You can effectively freeze that dose with tavapadon for the same period of time, approximately a year and a half. So you have this setup in those patients that are trying to optimize oral therapy, and giving tavapadon allows them to do that very quickly, which is really nice to see because that efficacy is observed early on.

    我們也看到,在目前已經使用左旋多巴-卡比多巴的病人身上,同樣的效果以稍微不同的形式呈現。使用 tavapadon,你可以在同樣的時間範圍內有效地把左旋多巴-卡比多巴的劑量「凍結」住,大約一年半。因此,對於那些想要最佳化口服治療的病人,你就有這樣的治療配置;加入 tavapadon 能讓他們很快做到這點,這點很令人欣慰,因為我們很早就觀察到療效。

  • Then as time goes by, because this is likely, and Jeff will talk about this, where likely it will first get utilized, and people will then recognize that there is a potential in earlier parts, and this is due to access elements that Jeff can now speak about.

    接著隨著時間推移,因為這很可能會發生,而 Jeff 也會談到這點:它很可能會先在最先被採用的地方開始使用,之後人們會認知到在更早期階段也存在潛力;這與 Jeff 現在可以談到的可近性(access)要素有關。

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah. Mohit, the market feedback has been quite strikingly positive so far, and it is exactly that. There's two elements of it. The first is this data that Roopal described where, when you add it on, you essentially freeze any dose escalations in almost all the patients for 85 weeks and counting. So the movement disorder experts and the neurologists, they know that as they continue to dose up and you have to escalate levodopa-carbidopa dosing, it just leads to the dyskinesia, and it's not good.

    是的。Mohit,到目前為止市場回饋相當顯著地正面,正是如此。這裡面有兩個要素。第一個是 Roopal 所描述的數據:當你把它加上去時,基本上在幾乎所有患者身上,你可以在 85 週且仍在持續計算中,幾乎凍結任何劑量上調。因此,動作障礙專家與神經科醫師都知道,當他們持續加量、必須提高左旋多巴-卡比多巴(levodopa-carbidopa)的劑量時,只會導致異動症(dyskinesia),而這並不好。

  • So the efficacy from the trials has been quite striking, and that's balanced really well with these low rates of really, we call it somnolence, but the Parkinson's experts know it's like a sleep attack. The patients can really get in trouble with the sleepiness, the sedation, and these sleep attacks, and very little to no observed impulse control disorders. That's what really harmed the first generation of the agents that didn't focus on D1, D5, but D2, D3. So we actually have been quite surprised at how strong the profile has been reacted to. Now, it's only been a matter of a few weeks.

    因此,試驗所呈現的療效相當令人印象深刻,而這也與非常低的發生率取得了很好的平衡——我們稱之為嗜睡(somnolence),但帕金森氏症領域的專家知道那就像是「睡眠突襲」。患者可能會因為嗜睡、鎮靜以及這些睡眠突襲而真的陷入麻煩;同時幾乎沒有觀察到衝動控制障礙。這正是第一代藥物真正受挫的原因:它們並非聚焦於 D1、D5,而是 D2、D3。所以我們其實對市場對這個特徵組合反應如此強烈感到相當意外。

  • What we also see that's been surprising is patients are aware of it, and they're pushing some of their neurologists and movement disorder experts. In terms of upside, we know that we've missed sort of the Medicare window for '27. We'd love to be able to sort of see if we can get some early adds. That's sort of speculative at this point. But we are very, very encouraged at the initial market reaction that we're seeing.

    另外一個讓我們意外的是,患者也知道這件事,並且正在推動他們的一些神經科醫師與動作障礙專家。就上行空間而言,我們知道我們已經錯過了 2027 年的 Medicare 視窗期。我們很希望能看看是否可以爭取一些提前納入。目前這仍屬推測。但我們對目前看到的初期市場反應感到非常、非常振奮。

  • And right now, because there is no access, all we can see is sort of enrollments and people are going through medical exception processes. The high-level demand in the funnel has been exceeding our initial expectations. So stay tuned. It looks like a very, very strong asset, and we'll just continue to watch it and press over time.

    而目前因為尚無可近性(access),我們能看到的只有類似入組(enrollments)的情況,以及人們正在走醫療例外(medical exception)流程。漏斗(funnel)中的高層級需求已超出我們最初的預期。所以敬請期待。看起來這是一項非常、非常強的資產,我們會隨時間持續觀察並推進。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Mohit. We are cognizant that another peer call is starting shortly, so we just have time for one final question.

    謝謝你,Mohit。我們也注意到另一場同業電話會議很快就要開始,因此我們只剩下一個最後問題的時間。

  • Operator

    Operator

  • Gary Nachman, Canaccord Genuity.

    Canaccord Genuity 的 Gary Nachman。

  • Gary Nachman - Equity Analyst

    Gary Nachman - Equity Analyst

  • With the new indications for RINVOQ in vitiligo and alopecia areata, will it be positioned as first line for both of those conditions? I know you said $2 billion plus for that in terms of the market opportunity, but review how big those markets are a little bit more specifically, and how much you will be increasing your presence even more with the derms after those approvals.

    隨著 RINVOQ 在白斑症(vitiligo)與圓形禿(alopecia areata)的新適應症獲批,它是否會在這兩種疾病中都被定位為第一線治療?我知道你提到就市場機會而言是 20 億美元以上,但請更具體地回顧一下這些市場的規模有多大,以及在獲批後你們將如何進一步提升在皮膚科醫師(derms)中的佈局與能見度。

  • Jeff Stewart - Executive Vice President, Chief Commercial Officer

    Jeff Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah. Thanks, Gary. Great questions. As you know, as I mentioned in my remarks, we did raise the long-term targets for both of those based on the quality of the data. So alopecia data was substantially better than we anticipated, really transformationally. This is that you have the ability on the so-called SALT score, in some cases, to completely regrow hair or get 90% hair regrowth at rates that we have not seen before. So that is been positive.

    是的。謝謝你,Gary。問題很好。如你所知,正如我在發言中提到的,我們確實基於數據品質,上調了這兩個適應症的長期目標。因此,圓形禿的數據明顯優於我們的預期,幾乎具有變革性。也就是說,在所謂的 SALT 評分上,在某些情況下,你有能力讓頭髮完全再生,或達到 90% 的毛髮再生率,這是我們以前未曾見過的水準。所以這是正面的。

  • Vitiligo data, when we look at it, is going from strength to strength. So we continue to see through 76 weeks that we are progressively improving the repigmentation. As you may recall, it will be the first ever systemic treatment. There are some topical creams, but it is the one for higher body surface areas. So both of these markets are very, very small right now.

    白斑症的數據方面,我們觀察到它是愈來愈強。因此,我們持續看到在 76 週時,復色(repigmentation)仍在逐步改善。如你可能記得,這將會是史上第一個全身性(systemic)治療。目前有一些外用乳膏,但這個治療是針對較大體表面積的患者。所以這兩個市場目前都非常、非常小。

  • I mean, if you look at the sales, they are in the small hundreds of millions of dollars. But if you look at their prevalence, they are quite high. That is the same way Crohn's was back in the day, and ulcerative colitis, et cetera. So we see that we are going to have to build the market. We see that RINVOQ will have the most favorable data in the category for the foreseeable future, so that is also very positive.

    我的意思是,如果你看銷售額,它們只有數億美元、且屬於較小的規模。但如果你看盛行率(prevalence),其實相當高。這就像當年克隆氏症(Crohn's)與潰瘍性結腸炎等疾病一樣。因此我們認為我們將必須去建立市場。我們認為在可預見的未來,RINVOQ 會在同類別中擁有最有利的數據,因此這也非常正面。

  • We are anticipating with the label that we will have more, now for moderate to severe patients, more of a frontline-type approach versus stepping through, because there is really nothing to step through. You sort of have a naive market. It is quite similar to what we saw with our GCA label, which is the smallest of the next ones. So we believe that these markets can become quite meaningful.

    我們預期在標籤(label)上,對於中度至重度患者,我們將能採取更偏向第一線的策略,而不是必須逐步嘗試其他治療,因為其實沒有什麼可逐步嘗試的。你面對的是一個相對「未開發/未被治療」的市場。這與我們在 GCA 標籤上看到的情況非常相似,而那是接下來幾個之中規模最小的一個。因此我們相信這些市場可以變得相當有意義。

  • We have increased our guidance based on the quality of the data. We will be the ones with the heavy lifting, and we plan to do that with expanding our dermatology sales forces around the world, and that has been underway. So we are going to invest into these indications.

    我們已基於數據品質上調了我們的指引。我們會是承擔主要開拓工作的那一方,我們計畫透過在全球擴大皮膚科銷售團隊來做到這點,而這項工作已在進行中。因此我們將投資於這些適應症。

  • And certainly, in the US, we would also anticipate pretty robust consumer activation, because we find that the vitiligo and alopecia patients, there has been nothing for them, so they are sort of sitting on the sidelines. That is the combination of the approaches there. We are certainly encouraged with the data and our ability to build those markets into the LRP.

    當然,在美國,我們也預期會有相當強勁的消費者端推廣(consumer activation),因為我們發現白斑症與圓形禿患者一直以來都沒有治療選項,所以他們某種程度上一直在觀望。這就是我們在此採取的組合式策略。我們對這些數據以及我們將這些市場建構並納入 LRP 的能力,確實感到鼓舞。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Gary。今天的電話會議到此結束。如果你想收聽會議重播,請造訪我們的網站 investors.abbvie.com。再次感謝各位加入。

  • Operator

    Operator

  • This concludes today's call. Thank you for your participation. You may now disconnect.

    今天的電話會議到此結束。感謝各位的參與。你現在可以掛線。