艾伯維 (ABBV) 2026 Q2 法說會逐字稿

內容摘要

  1. 摘要
    • Q2 營收近 170 億美元,年增 10.2%,超出預期 3 億美元;調整後 EPS 為 3.65 美元,超出指引中值 0.06 美元
    • 上修 2026 全年營收指引至約 676 億美元,全年 EPS 指引上調至 13.87-14.07 美元,反映業務動能與 Apogee 併購稀釋
    • 市場反應未明確揭露,但管理層強調業績超預期、產品組合動能強勁
  2. 成長動能 & 風險
    • 成長動能:
      • Skyrizi、Rinvoq 與神經科學產品組合均維持 20% 以上成長,推動整體營收動能
      • Skyrizi 在全球超過 30 國取得市佔領導,於乾癬、IBD 等適應症持續擴大滲透率
      • Rinvoq 在腸胃、皮膚科領域持續擴張,歐洲已獲批新適應症(白斑、斑禿),美國審查中
      • 神經科學事業群(Vraylar、Botox Therapeutic、Qulipta、VYALEV)均有雙位數成長,Parkinson’s pipeline(tavapadon)具長線潛力
      • Apogee Therapeutics 併購案將強化免疫學產品線,帶來皮膚、呼吸及相關炎症疾病新資產
    • 風險:
      • Humira 全球銷售年減 36.1%,受生物相似藥競爭影響,符合預期但為營收下行壓力
      • 美國與歐洲市場競爭加劇,部分產品(如 Juvederm、IMBRUVICA)面臨價格與市佔壓力
      • Apogee 併購帶來短期 EPS 稀釋與利息費用增加
      • 部分新藥(如 Skyrizi、Rinvoq)未來專利保護期與競爭動態需持續關注
  3. 核心 KPI / 事業群
    • Skyrizi 全球銷售:55 億美元,年增 24%,乾癬與 IBD 滲透率持續提升
    • Rinvoq 全球銷售:25 億美元,年增 23.7%,腸胃領域預計全年成長 30%
    • Humira 全球銷售:7.56 億美元,年減 36.1%,受生物相似藥影響
    • 神經科學事業群營收:32 億美元,年增約 20%
    • Vraylar 全球銷售:近 11 億美元,年增約 19%
    • VYALEV(Parkinson’s):2.56 億美元,季增 27%,預計今年達 blockbuster
    • Oncology 營收:16 億美元,年減 2.4%;VENCLEXTA 銷售 7.71 億美元,年增 9.6%
    • Aesthetics 營收:13 億美元,年減 0.9%;Botox Cosmetic 銷售 7.28 億美元,年增 3.4%;Juvederm 銷售 2.45 億美元,年減 6.6%
  4. 財務預測
    • 2026 全年營收預估約 676 億美元,上修 3 億美元
    • 全年調整後毛利率預估超過 84%
    • 全年 CapEx 未明確揭露
  5. 法人 Q&A
    • Q: Skyrizi subcutaneous induction(皮下注射誘導劑型)審查進度與信心?Skyrizi + alpha4 beta7 組合數據何時發表?
      A: 審查進度順利,無製程疑慮,資料完整;alpha4 beta7 組合數據預計今年秋季或明年大型醫學會發表
    • Q: Skyrizi 在乾癬市場競爭動態與成長空間?對 HS(膿瘍性汗腺炎)luti 與 Rinvoq 的信心?
      A: Skyrizi 乾癬市佔與新病患啟動率持續提升,競品上市未見負面影響,市場仍有顯著成長空間;luti 適用於早期患者,Rinvoq 聚焦於生物製劑失敗後患者,兩者定位互補
    • Q: Tavapadon(Parkinson’s)上市展望?CNS pipeline(如 brain shuttle)差異化優勢?
      A: Tavapadon 為首個選擇性 D1/D5 激動劑,數據顯示長期療效佳且副作用低,上市初期因給付流程預期成長較緩,但長線潛力大;brain shuttle 技術可顯著提升藥物進入腦脊液濃度,利於 Alzheimer’s 等適應症
    • Q: Oncology 策略與 Temab-A、PD-1 VEGF 進展?
      A: ADC 產品線已上市三項,Temab-A 在多適應症展現高反應率,將依數據推進至更早線治療並採生物標記導向策略,PD-1 VEGF 預計於 World Lung 會議公布數據,若數據佳將快速進入 Phase 3 並與 ADC 組合
    • Q: Rinvoq 在白斑、斑禿等新適應症面對競爭的信心?Bretasilisen(精神科新藥)定位?
      A: Rinvoq 為首個系統性治療白斑藥物,長期安全數據與多適應症推進具領先優勢;Bretasilisen 具短效、良好耐受性與潛在慢性用藥優勢,與現有精神科新藥差異化明顯

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

    早安,感謝各位稍候。歡迎參加艾伯維(AbbVie)2026 年第二季財報電話會議。(接線員指示)本次電話會議亦將錄音。如有任何異議,您可於此時中斷連線。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. 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 and Chief Financial Officer.

    早安,感謝各位加入。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.

    在開始之前,我先說明我們今天所做的部分陳述,可能會被視為基於目前預期的前瞻性陳述。艾伯維提醒,這些前瞻性陳述受風險與不確定性影響,可能導致實際結果與前瞻性陳述所示存在重大差異。

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

    關於這些風險與不確定性的更多資訊,已載於我們向美國證券交易委員會(SEC)提交的文件中。除法律要求外,艾伯維不承擔更新這些前瞻性陳述之義務。在今天的電話會議中,我們將使用非 GAAP 財務衡量指標,以協助投資人了解艾伯維的業務表現。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,相關資料可於我們網站查閱。在我們的準備發言後,將開放提問。

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

    那麼,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. AbbVie delivered another excellent quarter, with results once again exceeding our expectations. I'm especially pleased with the execution across our business, including double-digit sales growth from our diverse portfolio, the advancement of our compelling pipeline of innovative medicines and our planned acquisition of Apogee Therapeutics, which represents an exciting opportunity to bolster AbbVie's leading immunology portfolio. .

    謝謝你,Liz。各位早安,感謝各位加入。艾伯維再度交出一個非常出色的季度,業績再次超出我們的預期。我特別滿意我們在各項業務上的執行力,包括多元產品組合帶來的雙位數銷售成長、具吸引力的創新藥物研發管線持續推進,以及我們計畫收購 Apogee Therapeutics;這代表一個令人振奮的機會,可強化艾伯維在免疫學領域的領先產品組合。.

  • Turning to our second quarter performance. We achieved adjusted earnings per share of $3.65, which is $0.06 above our guidance midpoint. Total net revenues were nearly $17 billion dollars, beating our expectations by $300 million and reflecting robust sales growth of 10.2%. The performance of Skyrizi, Rinvoq and our Neuroscience portfolio continues to be very strong, with each delivering growth above 20%. Based on this momentum, we are raising our full year revenue guidance by $300 million, and have now raised total revenue by $600 million since the start of the year.

    接著談第二季表現。我們達成調整後每股盈餘(EPS)3.65 美元,較指引中位數高出 0.06 美元。總淨營收接近 170 億美元,較我們預期高出 3 億美元,並反映 10.2% 的強勁銷售成長。Skyrizi、Rinvoq 以及我們的神經科學產品組合表現持續非常強勁,三者成長率皆超過 20%。基於此動能,我們將全年營收指引上調 3 億美元;自年初以來,我們已累計上調總營收 6 億美元。

  • Turning now to R&D. We continue to make excellent progress advancing our pipeline. Recent highlights from our late-stage programs include the US approval of Decnupaz, a treatment for a rare form of blood cancer. This represents AbbVie's first marketed ADC in hematology.

    接著談研發(R&D)。我們持續在推進研發管線方面取得極佳進展。近期後期(late-stage)計畫的亮點包括:Decnupaz 在美國獲批,用於治療一種罕見血液癌症。這是艾伯維在血液腫瘤領域首個上市的 ADC(抗體藥物複合體)。

  • We also received European approval for Qulipta to treat acute migraine, Epkinly for second-line follicular lymphoma as well as Boey a first-in-class short-acting toxin in Aesthetics. In addition, we received European approvals for Rinvoq in both vitiligo and alopecia areata with U.S. regulatory decisions forthcoming. Based on the compelling data generated for each of these programs, we now anticipate the combined peak sales for these two indications alone to approach $2 billion, which is meaningfully above our prior expectations.

    我們也在歐洲取得多項核准:Qulipta 用於治療急性偏頭痛;Epkinly 用於二線濾泡性淋巴瘤;以及 Boey——美學領域首創(first-in-class)的短效毒素。此外,Rinvoq 亦在歐洲獲批用於白斑症與圓形禿,並將陸續迎來美國監管決定。基於各項計畫所產生的具說服力數據,我們目前預期僅這兩個適應症合計的峰值銷售額就可接近 20 億美元,顯著高於我們先前的預期。

  • During the quarter, we also announced the acquisition of Apogee Therapeutics which will add multiple differentiated assets in dermatology, respiratory and other related inflammatory diseases with significant sales potential. The acquisition will add even more depth to our robust pipeline in Immunology, which we expect will be a major growth driver for AbbVie over the long term.

    本季期間,我們也宣布收購 Apogee Therapeutics,將在皮膚科、呼吸道及其他相關發炎性疾病領域新增多項具差異化的資產,並具備可觀的銷售潛力。此收購將為我們在免疫學領域的強勁研發管線增添更深厚的布局;我們預期免疫學將在長期成為艾伯維的重要成長動能。

  • This transaction is an excellent fit with our strategy to build and advance a compelling pipeline with new sources of growth to support AbbVie's performance in the 2030s and beyond. We have ample financial capacity for more business development and remain focused on adding both early and late-stage opportunities across our core disease areas. In summary, we are delivering outstanding execution across our business, and our long-term outlook remains very strong.

    這筆交易非常符合我們的策略:打造並推進具吸引力的研發管線,開拓新的成長來源,以支撐艾伯維在 2030 年代及更長遠的表現。我們具備充足的財務能力進行更多業務開發,並持續聚焦於在核心疾病領域中,同時補強早期與後期的機會。總結而言,我們在各項業務上展現卓越的執行力,而我們的長期展望依然非常強勁。

  • 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?

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Thank you, Rob. I'll start with the quarterly results for Immunology, which delivered total revenues of nearly $8.8 billion dollars, reflecting very strong operational sales growth of 14.6%. And Skyrizi total sales were $5.5 billion dollars, up 24% on an operational basis, once again exceeding our expectations. I'm very pleased with our performance in psoriasis, where we continue to capture robust in-place share of new and switching patients at a rate which is impressively four times higher than any other biologic or oral treatment in the U.S.

    謝謝你,Rob。我先從免疫學的季度表現談起:總營收接近 88 億美元,反映非常強勁的營運面銷售成長 14.6%。Skyrizi 總銷售額為 55 億美元,以營運面計成長 24%,再次超出我們的預期。我對我們在乾癬領域的表現非常滿意;我們持續在新治療與換藥病人中取得強勁的既有市場份額(in-place share),其速度令人印象深刻,為美國任何其他生物製劑或口服治療的四倍。

  • We have achieved market share leadership now in more than 30 countries and see substantial room for continued growth globally. We do not expect a material impact to our robust outlook in psoriasis from existing or new therapies given Skyrizi's very distinct profile. This includes high and very durable skin clearance from head to toe, widely demonstrated superior efficacy in head-to-head trials versus five different mechanisms, including both biologics and oral agents.

    我們目前已在超過 30 個國家取得市占領先地位,並看到全球仍有相當大的持續成長空間。鑑於 Skyrizi 非常鮮明的產品特性,我們不預期現有或新療法會對我們在乾癬領域的強勁展望造成重大影響。這些特性包括:從頭到腳的高且非常持久的皮膚清除效果;以及在與五種不同作用機轉(包含生物製劑與口服藥物)的頭對頭試驗中,廣泛證實的優異療效。

  • Simple and convenient quarterly dosing and extremely strong long-term data in psoriatic arthritis, extending now to five years which is very important to prescribers as roughly 30% of psoriasis patients ultimately develop PsA as well as now our recent approval for pediatric use with the new weight-based dosing option.

    此外,Skyrizi 具備簡單便利的每季一次給藥;在乾癬性關節炎(PsA)方面也有極為強勁的長期數據,目前已延伸至五年,這對處方醫師非常重要,因為約 30% 的乾癬患者最終會發展為 PsA;同時,我們近期也獲得兒科使用核准,並提供新的依體重調整劑量選項。

  • In IBD, Skyrizi's fastest-growing indication, we continue to capture a leading share of total new patient starts in the U.S. in the quarter, including substantial leadership in the front-line setting; the clearest signal of physician preference. Competitive dynamics remain in line with our expectations with the IL-23 category seeing very robust growth in both Crohn's Disease and ulcerative colitis.

    在發炎性腸道疾病(IBD)方面,Skyrizi 的成長最快適應症,我們本季持續在美國取得總新病人起始治療(new patient starts)的領先份額,且在第一線治療情境中也具顯著領先;這是醫師偏好的最明確訊號。競爭態勢仍符合我們的預期,IL-23 類別在克隆氏症與潰瘍性結腸炎兩者中皆呈現非常強勁的成長。

  • Importantly, we are also preparing for the potential approval of our subcutaneous induction dosing option for Crohn's later this fall, which is supported by very strong data, particularly in the front-line where we observed the highest levels of endoscopic response seen in the category.

    重要的是,我們也正為今年秋季稍晚可能核准的克隆氏症皮下誘導劑量(subcutaneous induction dosing)選項做準備;該選項有非常強勁的數據支持,尤其在第一線治療中,我們觀察到該類別中最高水準的內視鏡反應率。

  • Turning now to Rinvoq which is also performing above our expectations. Global sales were more than $2.5 billion dollars, up 23.7% on an operational basis. I'm especially pleased with the momentum we see in gastroenterology, where Rinvoq is on pace to deliver 30% global sales growth this year. Rinvoq has set a very high bar for efficacy in both ulcerative colitis and Crohn's disease, demonstrating strong rates of remission and endoscopic improvement.

    接著談 Rinvoq,其表現同樣優於我們的預期。全球銷售額超過 25 億美元,以營運面計成長 23.7%。我特別滿意我們在腸胃科領域所見的動能;Rinvoq 今年有望達成全球銷售成長 30%。Rinvoq 在潰瘍性結腸炎與克隆氏症兩者的療效門檻已設得非常高,展現出強勁的緩解率與內視鏡改善率。

  • And we continue to see a nice inflection of in-play patient share following the recently expanded label supporting access to Rinvoq earlier in the treatment paradigm for IBD patients. More broadly, we continue to see strong demand across all of Rinvoq’s indications, and we are very excited about the growth potential in dermatology with vitiligo, alopecia areata now approved in Europe, with U.S. approval decisions anticipated over the next few quarters. Rinvoq's profile is competitively positioned for both of these chronic diseases where our recently expanded U.S. derm field force will support both launches.

    我們持續看到,隨著近期擴大適應症標籤、支持讓 IBD 患者在治療流程中更早取得 Rinvoq,用藥中的患者市占率出現良好拐點。更廣泛而言,我們持續看到 Rinvoq 在所有適應症上需求強勁;我們也對皮膚科在白斑症(vitiligo)與圓形禿(alopecia areata)的成長潛力感到非常振奮,圓形禿目前已在歐洲獲批,且預期未來幾季將迎來美國的核准決策。Rinvoq 的產品特性在這兩種慢性疾病上具備良好的競爭定位;我們近期擴編的美國皮膚科外勤團隊將支援兩項上市推進。

  • Lastly, in Immunology, Humira global sales were $756 million dollars, down 36.1% on an operational basis, reflecting biosimilar competition and in-line with our expectations. Moving to Neuroscience, where we once again, outperformed our expectations. Total revenues were more than $3.2 billion dollars, up approximately 20% on an operational basis.

    最後,在免疫學方面,Humira 全球銷售額為 7.56 億美元,按營運基礎下降 36.1%,反映生物相似藥競爭,且符合我們的預期。接著談神經科學,我們再次表現優於預期。總營收超過 32 億美元,按營運基礎約成長 20%。

  • All three of our leading neuro pillars continue to demonstrate robust sales growth. In psychiatry, Vraylar global sales were nearly $1.1 billion dollars, up approximately 19%, reflecting share gains in both bipolar disorder and adjunctive MDD. In migraine, our leading portfolio continues to deliver outstanding results with Botox Therapeutic, Ubrelvy and Qulipta each delivering double-digit sales growth again this quarter.

    我們三大核心神經領域支柱皆持續展現強勁的銷售成長。在精神醫學方面,Vraylar 全球銷售額接近 11 億美元,約成長 19%,反映其在雙相情感障礙與作為重鬱症(MDD)輔助治療上的市占提升。在偏頭痛方面,我們的領先產品組合持續交出亮眼成果;Botox Therapeutic、Ubrelvy 與 Qulipta 本季再次皆達成雙位數銷售成長。

  • Qulipta is now approved in Europe for adults as both an acute treatment option for migraine attacks and as a once-daily preventative treatment option for chronic or episodic migraine. The acute indication expansion in international markets for Qulipta further supports our long-term outlook for our oral CGRPs to collectively achieve more than $5 billion dollars of peak sales.

    Qulipta 現已在歐洲獲准用於成人,既可作為偏頭痛發作的急性治療選項,也可作為每日一次的慢性或發作性偏頭痛預防治療選項。Qulipta 在國際市場的急性適應症擴展,進一步支持我們對口服 CGRP 類藥物長期展望:合計峰值銷售額可望超過 50 億美元。

  • Moving to Parkinson's disease, another substantial long-term growth driver for AbbVie. Total sales for VYALEV were $256 million dollars, up more than 27% on a sequential basis. VYALEV is well on track to achieve blockbuster sales this year. And we expect continued robust momentum in Parkinson's with the anticipated U.S. approval and launch of Tavapadon in the third quarter.

    接著談帕金森氏症,這也是 AbbVie 另一項重要的長期成長驅動因素。VYALEV 總銷售額為 2.56 億美元,較前一季成長超過 27%。VYALEV 今年有望如期達成重磅藥(blockbuster)銷售。此外,隨著預期 Tavapadon 將於第三季在美國獲批並上市,我們預期帕金森氏症領域將延續強勁動能。

  • Feedback from key opinion leaders has been very positive with Tavapadon demonstrating strong efficacy as both a monotherapy as well as an add-on to standard of care. Overall, we believe our Parkinson's portfolio with Vyalev, Tavapadon, and Duopa will be a substantial commercial opportunity. We continue to expect collective Parkinson's peak sales of more than $5 billion dollars.

    關鍵意見領袖的回饋非常正面;Tavapadon 無論作為單一療法或加用於標準治療,皆展現強勁療效。整體而言,我們相信由 Vyalev、Tavapadon 與 Duopa 組成的帕金森氏症產品組合將帶來可觀的商業機會。我們仍預期帕金森氏症合計峰值銷售額將超過 50 億美元。

  • Turning now to Oncology, where total revenues were more than $1.6 billion dollars, down 2.4% on an operational basis. Total Venclexta sales were $771 million dollars, up 9.6% on an operational basis. Performance in CLL continues to be strong as Venclexta use in combination with BTK inhibitors and is expanding as a preferred fixed duration treatment globally. Double-digit sales growth from Elahere, Epkinly, and Emrelis also helped to partially offset the sales decline for Imbruvica, which was down 29.4% as expected due to IRA pricing and competitive share pressure.

    接著談腫瘤科,總營收超過 16 億美元,按營運基礎下降 2.4%。Venclexta 總銷售額為 7.71 億美元,按營運基礎成長 9.6%。在慢性淋巴性白血病(CLL)方面表現持續強勁;Venclexta 與 BTK 抑制劑的合併使用正在擴大,並在全球逐步成為偏好的固定療程(fixed duration)治療。Elahere、Epkinly 與 Emrelis 的雙位數銷售成長,也部分抵銷了 Imbruvica 的銷售下滑;Imbruvica 按預期下降 29.4%,主要因 IRA 定價影響與競爭性市占壓力。

  • We also launched Decnupaz, a new therapeutic option for patients living with BPDCN, an ultra-rare form of blood cancer, further expanding AbbVie's emerging ADC portfolio. Moving now to Aesthetics, which delivered global sales of nearly $1.3 billion dollars, down 0.9% on an operational basis. Botox Cosmetic total revenues were $728 million dollars, up 3.4% operationally, reflecting modest market growth globally. Juvederm Global sales were $245 million dollars, down 6.6% operationally, reflecting continued headwinds in key dermal filler markets.

    我們也推出 Decnupaz,為罹患 BPDCN(極罕見的血液癌症)患者提供新的治療選項,進一步擴充 AbbVie 新興的 ADC 產品組合。接著談醫學美容(Aesthetics),全球銷售額接近 13 億美元,按營運基礎下降 0.9%。Botox Cosmetic 總營收為 7.28 億美元,按營運基礎成長 3.4%,反映全球市場溫和成長。Juvederm 全球銷售額為 2.45 億美元,按營運基礎下降 6.6%,反映主要皮膚填充劑市場持續面臨逆風。

  • As the industry leader, we continue to invest in this highly underpenetrated market to support long-term growth. I'm especially pleased with the recent Europe and Canada approvals of Boey our fast-acting short-duration toxin -- while we complement our toxin portfolio very nicely and represents a new way for patients to initiate an aesthetic treatment. We expect Boey will meaningfully expand the toxin market and look forward to potentially bringing this exciting innovation to the U.S. overall, we continue to demonstrate outstanding commercial execution.

    作為產業領導者,我們持續投資於這個滲透率仍偏低的市場,以支持長期成長。我尤其高興看到 Boey(我們的速效、短效肉毒毒素)近期在歐洲與加拿大獲批——它能非常好地補強我們的毒素產品組合,並為患者提供一種啟動醫美療程的新方式。我們預期 Boey 將顯著擴大毒素市場,並期待有機會將這項令人振奮的創新帶到美國。整體而言,我們持續展現卓越的商業執行力。

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

    接下來,我把電話會議交給 Roopal,請她分享我們研發(R&D)的重點進展。Roopal?

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

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

  • Thank you, Jeff. I'll begin with dermatology programs in Immunology. Rinvoq was approved in Europe for the treatment of severe alopecia and non-segmental vitiligo. Applications are also under review in the U.S. with approval decisions anticipated later this year for vitiligo and early next year for alopecia areata.

    謝謝你,Jeff。我先從免疫學中的皮膚科專案談起。Rinvoq 已在歐洲獲准用於治療重度圓形禿與非節段型白斑症。相關申請也正在美國審查中;預期白斑症將於今年稍晚做出核准決策,而圓形禿則預期在明年初。

  • In hidradenitis suppurativa, we remain on track for 16-week data later this year from both Rinvoq and Lutikizumab Phase 3 trials. In our early-stage dermatology pipeline, three programs were recently advanced into the clinic, including an IL-13, IL-31 receptor bispecific antibody for atopic dermatitis, an oral IL-23 receptor inhibitor for psoriasis and a long-acting IL-1 alpha beta bispecific antibody for hidradenitis suppurativa.

    在化膿性汗腺炎(hidradenitis suppurativa)方面,我們仍按計畫於今年稍晚取得 Rinvoq 與 Lutikizumab 第三期試驗的 16 週數據。在早期皮膚科研發管線方面,近期有三個專案推進至臨床階段,包括:用於異位性皮膚炎的 IL-13/IL-31 受體雙特異性抗體、用於乾癬的口服 IL-23 受體抑制劑,以及用於化膿性汗腺炎的長效 IL-1α/β 雙特異性抗體。

  • Turning to gastroenterology. The U.S. application for Skyrizi subcutaneous induction in Crohn's disease is under review with an approval decision expected later this fall. The subcutaneous regimen demonstrated very high levels of endoscopic response and clinical remission, with rates on both measures 25 points higher than placebo in the overall population and 45 points higher in patients who had not previously experienced advanced therapy.

    接著談腸胃科。Skyrizi 用於克隆氏症的皮下誘導治療之美國申請正在審查中,預期將於今年秋季稍晚做出核准決策。該皮下療程在內視鏡反應與臨床緩解方面皆展現非常高的水準;在整體族群中,兩項指標的比率均較安慰劑高出 25 個百分點,而在先前未接受過進階治療的患者中則高出 45 個百分點。

  • To our knowledge, these results in patients naive to advanced therapies are the highest reported for induction therapies in Crohn's disease, comparing very favorably to Skyrizi IV and other approved agents. Full results from the study will be presented this fall, which will include additional important endpoints, such as endoscopic remission.

    據我們所知,這些在未曾接受進階治療患者中的結果,是克隆氏症誘導治療中所報告的最高水準,與 Skyrizi 靜脈注射(IV)以及其他已核准藥物相比也非常有利。本研究的完整結果將於今年秋季發表,內容將包含其他重要終點,例如內視鏡緩解。

  • Startup activities are underway for our Phase 2B combination trial in IBD. This multi-arm study will evaluate Skyrizi plus a higher dose of our novel anti-alpha4 beta7 antibody and extended half-life TL1A antibody in both Crohn's disease and ulcerative colitis. Interim results for Skyrizi plus anti-alpha4beta-7 in Crohn's disease demonstrated a doubling of endoscopic remission at week 24 and compared to either monotherapy.

    我們針對 IBD 的第 2B 期合併治療試驗已啟動前期作業。這項多臂研究將在克隆氏症與潰瘍性結腸炎中,評估 Skyrizi 合併較高劑量的新型抗 α4β7 抗體,以及延長半衰期的 TL1A 抗體。Skyrizi 合併抗 α4β7 用於克隆氏症的期中結果顯示:第 24 週的內視鏡緩解率較任一單藥治療提高一倍。

  • This study is expected to complete this fall, and final results will be submitted for presentation at a future medical meeting. And lastly, in Immunology, we announced the planned acquisition of Apogee Therapeutics, which adds a portfolio of long-acting biologics targeting atopic dermatitis, respiratory conditions and other immune-mediated diseases. These novel assets are highly complementary to our Immunology strategy and further strengthen an already robust pipeline.

    預期本研究將於今年秋季完成,最終結果將提交至未來的醫學會議發表。最後,在免疫學方面,我們宣布計畫收購 Apogee Therapeutics,將新增一系列針對異位性皮膚炎、呼吸道疾病及其他免疫介導疾病的長效生物製劑產品組合。這些新型資產與我們的免疫學策略高度互補,並進一步強化原本就相當穩健的研發管線。

  • Moving to Neuroscience. Qulipta was approved in Europe for the acute treatment of migraine, expanding options for patients. In Parkinson's disease, an FDA approval decision is expected in the third quarter for tavapadan. Results from three Phase 3 trials demonstrated that this novel selective D1, D5 dopamine agonist has the potential to be a highly effective treatment for motor symptoms with low rates of dyskinesia, edema, sedation and impulse control disorder. We look forward to bringing this innovation to patients later this year.

    接著談神經科學。Qulipta 已在歐洲獲准用於偏頭痛的急性治療,為患者擴增治療選擇。在帕金森氏症方面,tavapadan 的 FDA 核准決定預計將於第三季出爐。三項第 3 期試驗結果顯示,這款新型選擇性 D1、D5 多巴胺致效劑,有望以低比例的異動症、水腫、嗜睡與衝動控制障礙,對運動症狀提供高度有效的治療。我們期待在今年稍晚將這項創新帶給患者。

  • In our early-stage Neuroscience pipeline, multiple new trials were recently initiated, including a Phase 2 study for a novel toxin Jemmy Made in essential tremor and a Phase 1b study for ABBV-1758, a blood-brain barrier crossing anti-pyroglutamate, A-beta antibody in Alzheimer's disease.

    在我們早期階段的神經科學研發管線中,近期啟動了多項新試驗,包括:針對原發性顫抖症之新型毒素 Jemmy Made 的第 2 期研究,以及針對 ABBV-1758 的第 1b 期研究;ABBV-1758 為可穿越血腦障壁、針對阿茲海默症之抗焦麩胺酸化 Aβ 抗體。

  • In schizophrenia, the multi-ascending dose study for emraclidine is nearing completion. The 100-milligram dose retained a safe and tolerable profile, and now 150 milligrams is being evaluated. Dose selection for both schizophrenia and psychosis programs is expected in the coming months, and we remain on track to begin Phase 2 studies in the fourth quarter.

    在思覺失調症方面,emraclidine 的多重遞增劑量研究已接近完成。100 毫克劑量維持安全且可耐受的特性,目前正評估 150 毫克。預計未來數月內將完成思覺失調症與精神病性疾患兩項計畫的劑量選擇,我們也仍按計畫於第四季啟動第 2 期研究。

  • Moving to solid tumor programs. Progress with Temab-A continues across a broad range of tumor types. In colorectal cancer, breakthrough therapy designation was granted for Temab-A in combination with bevacizumab in refractory metastatic CRC. This designation supports our Phase 3 strategy in an all-comer third-line plus setting. And the trial is now actively recruiting.

    接著談實體腫瘤計畫。Temab-A 在多種腫瘤類型中持續取得進展。在大腸直腸癌方面,Temab-A 與 bevacizumab 併用於難治性轉移性 CRC 已獲授予突破性療法認定。此認定支持我們在第三線以上、全人群(all-comer)情境下的第 3 期策略。該試驗目前正積極招募中。

  • In second-line CRC data are expected later this year from a Phase 2 study evaluating Temab-A combinations versus chemotherapy. These results will help inform the development strategy for Temab-A in first- and second-line CRC as in irinotecan replacement. Early-stage results in ovarian and head and neck cancers were presented at the recent ASCO meeting, demonstrating Temab-A’s potential in both tumor types.

    在第二線 CRC 方面,預計今年稍晚將公布一項第 2 期研究數據,該研究評估 Temab-A 聯合療法相較於化學治療的表現。這些結果將有助於制定 Temab-A 在第一線與第二線 CRC 的開發策略,例如作為 irinotecan 的替代方案。在近期 ASCO 年會上亦發表了卵巢癌與頭頸癌的早期結果,顯示 Temab-A 在兩種腫瘤類型皆具潛力。

  • In platinum-resistant ovarian cancer, Temab-A showed strong anti-tumor activity, particularly in c-MET selected patients where response rates reached as high as 80%. The Temab-A also demonstrated a 50% response rate in clear cell carcinoma, a segment with high unmet need that typically does not respond well to cytotoxic therapy. Plans to advance Temab-A in ovarian cancer will be discussed with regulators over the coming months. In C-MET selected patients with advanced head and neck cancer, Temab-A demonstrated a 31% response rate and a median overall survival of 15.3 months, which compares favorably to standard of care.

    在鉑類抗藥性卵巢癌中,Temab-A 顯示強勁的抗腫瘤活性,尤其在 c-MET 篩選患者中,反應率最高可達 80%。Temab-A 在透明細胞癌中亦展現 50% 的反應率;此族群未滿足醫療需求高,且通常對細胞毒性治療反應不佳。未來數月內將與監管機關討論推進 Temab-A 於卵巢癌的計畫。在 c-MET 篩選之晚期頭頸癌患者中,Temab-A 顯示 31% 的反應率與 15.3 個月的中位總存活期,與標準治療相比具相對優勢。

  • A Phase 2 study evaluating Temab-A plus pembrolizumab in frontline will start soon. And in pancreatic cancer, a Phase 2 study evaluating Temab-A with FOLFOX as a frontline combination therapy was recently initiated. Turning to hematologic oncology. Progress continues with etentamig across lines of therapy in multiple myeloma. An interim analysis is planned in the third quarter or progression-free survival from the monotherapy third line plus trial.

    一項評估 Temab-A 併用 pembrolizumab 作為第一線治療的第 2 期研究將於近期啟動。此外,在胰臟癌方面,近期也已啟動一項第 2 期研究,評估 Temab-A 與 FOLFOX 作為第一線聯合治療。接著談血液腫瘤。etentamig 在多發性骨髓瘤的多個治療線別中持續推進。我們計畫於第三季針對單藥第三線以上試驗的無惡化存活期進行期中分析。

  • If this interim analysis is positive, regulatory submission would occur later this year. A Phase 3 study evaluating etentamig in combination with pomalidomide in second line plus patients, including those that were exposed or refractory to an anti-CD38 antibody or who lost response to an anti-BCMA CAR-T or AC, will begin by year-end.

    若該期中分析結果正向,將於今年稍晚進行法規申請送件。一項第 3 期研究將於年底前啟動,評估 etentamig 與 pomalidomide 併用於第二線以上患者,包括曾接受或對抗 CD38 抗體暴露/難治者,或對抗 BCMA CAR-T 或 AC 失去反應者。

  • Additionally, encouraging early-stage results for etentamig in relapsed-refractory light chain amyloidosis were presented at a recent EHA Congress. At the 40-milligram dose, 100% of patients achieved hematologic complete response with a promising safety profile that included no CRS or ICANS. Based on these results, a Phase 3 trial in newly diagnosed patients is being planned.

    此外,近期 EHA 大會亦公布了 etentamig 用於復發/難治性輕鏈類澱粉沉積症的早期鼓舞人心結果。在 40 毫克劑量下,100% 患者達到血液學完全緩解,且安全性概況具前景,未出現 CRS 或 ICANS。基於這些結果,正規劃在新診斷患者中進行第 3 期試驗。

  • Also in hematology, Decnupaz received FDA approval for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer as a new treatment alternative providing durable responses with a manageable safety profile and outpatient administration Decnupaz offers a meaningful benefit to patients with this rare cancer.

    同樣在血液領域,Decnupaz 已獲 FDA 核准用於芽細胞樣漿細胞樣樹突細胞腫瘤(BPDCN),這是一種極罕見且侵襲性的血液癌症;作為新的治療替代方案,Decnupaz 可提供持久反應、具可管理的安全性概況,並可於門診給藥,為此罕見癌症患者帶來具意義的效益。

  • Moving to Aesthetics. Our rapid onset and short duration toxin Boey was approved in Europe and Canada for the temporary improvement in appearance of glabellar lines. This marks an important milestone in aesthetic medicine. Boey was developed to allow patients to temporarily preview the benefits of cosmetic toxins without worrying about long-lasting results.

    接著談美學醫療。我們起效快速且作用時間短的肉毒桿菌毒素 Boey 已在歐洲與加拿大獲准,用於暫時改善眉間紋外觀。這是美學醫療的重要里程碑。Boey 的開發目的,是讓患者能在不必擔心效果持續過久的情況下,暫時預覽醫美肉毒毒素的效益。

  • Clinicians and patients now have another option to tailor treatment to individual needs and goals. In summary, we are making meaningful progress with our pipeline and look forward to additional important data readouts, regulatory submissions and approvals throughout the remainder of 2026.

    臨床醫師與患者如今多了一項選擇,可依個別需求與目標量身調整治療。總結而言,我們的研發管線正取得具意義的進展,並期待在 2026 年剩餘期間陸續迎來更多重要數據讀出、法規送件與核准。

  • 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. Starting with our second quarter results. We reported adjusted earnings per share of $3.65, which is $0.06 above our guidance midpoint. These results include a $0.17 unfavorable impact from acquired IPR&D expense. Quarterly net revenues were nearly $17 billion, reflecting robust growth of 10.2%, including a 0.7% favorable impact from foreign exchange.

    謝謝你,Roopal。先從第二季業績開始。我們公布的調整後每股盈餘為 3.65 美元,較我們指引中位數高出 0.06 美元。這些結果包含因併購取得之 IPR&D 費用帶來的 0.17 美元不利影響。單季淨營收接近 170 億美元,反映 10.2% 的強勁成長,其中包含外匯帶來的 0.7% 有利影響。

  • Adjusted gross margin was 84.7% of sales, adjusted R&D expense was 13.6% of sales and adjusted SG&A expense was 21% of sales. The adjusted operating margin was 48.3% of sales which includes a 1.7% unfavorable impact from acquired IPR&D expense. Net interest expense was $679 million dollars. The adjusted tax rate was 14.7%.

    調整後毛利率為銷售額的 84.7%,調整後研發費用為銷售額的 13.6%,調整後銷售、一般及行政費用(SG&A)為銷售額的 21%。調整後營業利益率為銷售額的 48.3%,其中包含併購取得之 IPR&D 費用帶來的 1.7% 不利影響。淨利息費用為 6.79 億美元。調整後有效稅率為 14.7%。

  • Turning to our financial outlook. We are updating our full year adjusted earnings per share guidance to between $13.87 and $14.07. This update reflects a $0.10 improvement in the outlook of our existing business based on strong second quarter results and continued momentum. It also now includes $0.14 of anticipated dilution related to the planned Apogee acquisition that is more than offsetting our underlying overperformance. We continue to expect that the Apogee transaction will close in the third quarter.

    接著談我們的財務展望。我們將全年調整後每股盈餘指引更新為 13.87 至 14.07 美元。此更新反映在第二季強勁表現與持續動能帶動下,既有業務展望上調 0.10 美元。同時也納入與規劃中的 Apogee 併購相關、預期 0.14 美元的稀釋影響,但該影響已被我們基本面超預期表現所抵銷並有餘。我們仍預期 Apogee 交易將於第三季完成交割。

  • This guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the second quarter. We now expect total net revenues of approximately $67.6 billion dollars, increase of $300 million dollars. This assumes a roughly 0.5% favorable impact from foreign exchange on full year sales growth, reflecting less benefit than our previous expectation.

    本指引未包含第二季之後可能發生的併購取得 IPR&D 費用估計。我們目前預期全年淨營收約為 676 億美元,上調 3 億美元。此預估假設外匯對全年銷售成長約有 0.5% 的有利影響,反映其帶來的助益低於我們先前的預期。

  • Our increased revenue forecast includes the following approximate assumptions for several of our key products and therapeutic areas. We now expect Skyrizi global revenues of $21.7 billion, an increase of $100 million based on momentum across psoriatic and IBD indications. Total Neuroscience revenues of $12.7 billion, an increase of $100 million, now reflecting Vraylar sales approaching $4.1 billion and Botox Therapeutic sales approaching $4.2 billion. The remaining $100 million increase reflects momentum from Rinvoq and Venclexta. Moving to the P&L for 2026.

    我們上調的營收預測包含對數項關鍵產品與治療領域的以下約略假設。我們目前預期 Skyrizi 全球營收為 217 億美元,較前次增加 1 億美元,主要基於其在乾癬性關節炎與 IBD 適應症的動能。神經科學總營收為 127 億美元,增加 1 億美元;其中反映 Vraylar 銷售額接近 41 億美元,以及 Botox 治療用途銷售額接近 42 億美元。其餘增加的 1 億美元反映 Rinvoq 與 Venclexta 的動能。接著看 2026 年的損益表(P&L)。

  • We continue to forecast full year adjusted gross margin above 84% of sales. We now expect adjusted R&D expense of approximately $9.8 billion dollars, an increase of $100 million dollars reflecting Apogee related pipeline investments. We expect adjusted SG&A expense of approximately $14.5 billion dollars as we continue to support our significant commercial momentum.

    我們持續預測全年調整後毛利率將高於銷售額的84%。我們目前預期調整後研發費用約為98億美元,增加1億美元,反映與Apogee相關的研發管線投資。我們預期調整後銷售、一般及行政(SG&A)費用約為145億美元,因我們持續支持強勁的商業動能。

  • We anticipate an adjusted operating margin ratio approaching 47% of sales. We also expect adjusted net interest expense of approximately $2.9 billion dollars, an increase of $200 million, which reflects the partial year financing cost of the planned Apogee transaction.

    我們預期調整後營業利益率接近銷售額的47%。我們也預期調整後淨利息費用約為29億美元,增加2億美元,反映規劃中的Apogee交易之部分年度融資成本。

  • Finally, we now forecast our non-GAAP tax rate to be approximately 14.5% and which reflects the impact of acquired IPR&D. Turning to the third quarter. We anticipate net revenues of approximately $17.2 billion dollars which includes an estimated 0.4% unfavorable impact from foreign exchange. We also forecast adjusted earnings per share between $3.84 and $3.88. This guidance contemplates a partial quarter of dilution related to the planned Apogee transaction, but does not include acquired IPR&D expense that may be incurred in the quarter.

    最後,我們目前預測非GAAP稅率約為14.5%,並反映已收購的在研研發(IPR&D)影響。接著談第三季。我們預期淨營收約為172億美元,其中包含外匯帶來約0.4%的不利影響。我們也預測調整後每股盈餘介於3.84至3.88美元之間。此指引考量了規劃中的Apogee交易所帶來的部分季度稀釋,但不包含本季可能發生的已收購IPR&D費用。

  • Finally, AbbVie is financially well positioned to complete the planned Apogee acquisition. We have secured interim financing and expect to issue long-term debt in the coming months. We remain committed to achieving a net leverage ratio of 2 times, within two-to- three years following the deal close. Importantly, based on our strong cash flows, balance sheet and business outlook, we continue to have substantial financial flexibility to pursue additional innovative business development. In closing, AbbVie continues to deliver outstanding performance, and we are carrying significant momentum into the second half of 2026.

    最後,AbbVie在財務上具備完成規劃中Apogee收購案的良好條件。我們已取得過渡性融資,並預期在未來幾個月發行長期債務。我們仍致力於在交易完成後兩到三年內,達成淨槓桿比率2倍的目標。重要的是,基於我們強勁的現金流、資產負債表與業務展望,我們仍具備充足的財務彈性,以推動更多創新型業務發展。總結而言,AbbVie持續交出卓越表現,並在邁入2026年下半年時保持強勁動能。

  • 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. In the interest of hearing from as many analysts as possible over the remainder of the call, we ask that you please limit your questions to one or two. Operator, we'll take the first question.

    謝謝,Scott。我們現在開放提問。為了讓在接下來的時間能聽到更多分析師的提問,請將問題限制在一到兩個。接線員,我們先接第一個問題。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Terence Flynn, Morgan Stanley.

    Morgan Stanley的Terence Flynn。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Great. Congrats on all the progress. Maybe a two part for me on Skyrizi I know you have the FDA action on the subcutaneous formulation for induction coming up this fall. Maybe Roopal, you could just speak through confidence in that approval. There's everything on manufacturing lined up?

    很好。恭喜各項進展。我這邊可能有兩個問題,關於Skyrizi——我知道今年秋天FDA將對用於誘導治療的皮下劑型做出決定。Roopal,也許你可以談談你對該核准的信心。製造方面都已就緒了嗎?

  • Just want to make sure there's no issues there. And then on Skyrizi plus alpha4 beta7, some very exciting data looking forward to seeing that. Can you confirm yet if that will be at the UEGW conference in the fall? Thank you.

    只是想確認那邊沒有任何問題。另外,關於Skyrizi加上alpha4 beta7,數據非常令人振奮,期待看到更多。你能否確認這是否會在秋季的UEGW會議上發表?謝謝。

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

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

  • Thanks, Terence. It's Roopal. So on the CD subcutaneous Skyrizi as I highlighted, very strong data. It is with Skyrizi. So it's asset well known to health authorities and manufacturing is very well known to us.

    謝謝你,Terence。我是Roopal。關於CD(克隆氏症)皮下Skyrizi,如我所強調的,數據非常強勁。這是Skyrizi。因此它是主管機關非常熟悉的資產,而製造也為我們所非常熟悉。

  • So we have a very complete submission that's in front of the agency. And so far, that review is going according to plan. So no concerns at this moment. And then on the alpha4 beta7 combo data I didn't specifically call out a meeting because of the timing. What we provided earlier was interim data.

    因此我們已向主管機關提交非常完整的申請資料。截至目前,審查進度符合計畫。所以目前沒有疑慮。至於alpha4 beta7聯合治療數據,我沒有特別點名某個會議,主要是時間安排的關係。我們先前提供的是期中數據。

  • So as the rest of it comes in we would obviously try for later this fall. And if we're unable to get into that window, then it would go into next year congresses. So either way, we're very excited to show more of that data. And like I said, could be in the fall and if not possible, we'll see it next year.

    隨著其餘數據陸續出爐,我們當然會嘗試在今年秋季較晚的時間發表。如果無法趕上那個時間窗口,就會安排在明年的各項學術會議上發表。無論如何,我們都非常期待展示更多數據。如我所說,可能在秋天;若不可行,我們明年再見。

  • 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,請下一個問題。

  • Operator

    Operator

  • Carter Gould, Cantor Fitzgerald.

    Cantor Fitzgerald的Carter Gould。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • Great. Good morning. Thanks for taking the question. A follow-up for Roopal. The Phase 2 that you've talked about starting with the alpha4 beta7. It's a bit of a beast; 2,000 patients across a number of settings. Can you maybe just set the stage there. In the past, you've talked about speed, not the -- not waiting potentially for the full Phase 3 data or Phase 2 data before moving to Phase 3. Is that still in the cards? And in that study, it also talks about ABB466 with Skyrizi and Trosinilumab, is that a co-formulation or just a co-administration?

    很好。早安。謝謝讓我提問。我有一個給Roopal的追問。你提到將以alpha4 beta7啟動的第二期試驗。規模相當龐大;在多個情境下共2,000名病人。你能否先幫我們鋪陳一下背景。過去你談到速度——也就是在進入第三期前,可能不必等待完整的第三期數據或第二期數據。這個策略仍然適用嗎?另外,在該研究中也提到ABB466與Skyrizi及Trosinilumab,這是共劑型(co-formulation)還是僅為共同給藥(co-administration)?

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

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

  • Yeah. Thanks for the question. Yes, it's a large study. It's a platform study that -- similar to what we've run before. Skyrizi is the anchor asset will be combining Trosu or the alpha4 beta7 at even a higher dose than we studied previously. We are in parallel working on co-formulations. So the intent at launch for any of these assets in combination with Skyrizi and IBD would be a co-formulation.

    是的。謝謝你的問題。沒錯,這是一項大型研究。這是一個平台式試驗——類似我們過去執行過的設計。Skyrizi是核心(anchor)資產,將與Trosu或alpha4 beta7以比先前研究更高的劑量進行聯合。我們也同步在進行共劑型的開發。因此,這些資產未來若與Skyrizi在IBD(發炎性腸道疾病)中聯合上市,我們的目標會是共劑型。

  • So that data would be collected in Crohn's and ulcerative colitis in combination with Skyrizi. And then also the reasoning for the scale of that study is also the TL1A is in that trial as well, combined with Skyrizi in Crohn's disease and ulcerative colitis. The enrollment should be starting any moment where a patient will be entered. The trial is ready to go. The other question was around when we can start seeing data.

    因此,相關數據將在克隆氏症與潰瘍性結腸炎中,以與Skyrizi聯合的方式收集。此外,該研究之所以規模如此之大,也因為TL1A也納入此試驗,並與Skyrizi在克隆氏症與潰瘍性結腸炎中聯合評估。收案應該隨時會開始,也就是會有病人被納入。試驗已準備就緒。另一個問題是我們何時能開始看到數據。

  • We don't have an intention to wait until the end. If we will take a couple of interim snapshots. And if we see, for example, the higher dose of Trosu or the alpha4 beta7 agent is supporting higher efficacy, then we would start making plans to move into Phase 3 with that combination. And the same goes to the TL1A, if we start seeing really strong data, we would start moving quickly into Phase 3. We would anticipate right now, hopefully, in the first half of 2028 being able to kick off Phase 3 programs in IBD.

    我們不打算等到試驗結束才看結果。我們會進行幾次期中檢視。例如,如果我們看到較高劑量的Trosu或alpha4 beta7藥物能帶來更高療效,我們就會開始規劃將該聯合療法推進到第三期。TL1A也是同樣邏輯,如果開始看到非常強勁的數據,我們會快速推進到第三期。以目前來看,我們希望能在2028年上半年啟動IBD的第三期計畫。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

  • Thanks, Carter. Operator, next question please.

    謝謝你,Carter。接線員,請下一個問題。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    Chris Schott,摩根大通(JPMorgan)。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Great, thanks so much for the questions guys can I just come back to Skyrizi in psoriasis. I know you made some comments in terms of the launch of Icotyde and the impact or lack of impact that's had there. Just can you elaborate a bit more on just what you're seeing in terms of dynamics in psoriasis? And just how much more growth opportunity there is for Skyrizi in the setting given the higher penetration rates.

    很好,非常感謝各位的提問。我想回到乾癬(psoriasis)的 Skyrizi。我知道你們就 Icotyde 的上市以及它在那邊造成的影響或未造成的影響做了一些評論。能否再多談一點你們在乾癬市場看到的動態?另外,考量到較高的滲透率,在這個情境下 Skyrizi 還有多少成長空間?

  • Just then a quick second question is looking ahead to the upcoming readouts for Luti and Rinvoq in HS. Can you just talk about your relative confidence in those two assets and the role you see each playing in the market there?

    接著第二個簡短問題是,展望即將公布的 Luti 與 Rinvoq 在 HS 的讀出結果。能否談談你們對這兩個資產的相對信心,以及你們認為它們各自在該市場將扮演的角色?

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Hi, it's Jeff. I'll take the first question. And as I mentioned, the profile is very, very strong, as you know, the skin clearance, the joint protection, the safety, the convenience, it's a very unique product. And that's why I think we have such a high capture rate. We see a couple of things in the market, and I'll highlight them we've not seen a material change in our momentum since the launch of ICO.

    嗨,我是 Jeff。我先回答第一個問題。如我提到的,這個產品特性非常、非常強,你也知道:皮膚清除、關節保護、安全性、便利性——這是一個非常獨特的產品。這也是為什麼我認為我們有這麼高的捕捉率。我們在市場上看到幾件事,我來重點說明:自 ICO 上市以來,我們沒有看到我們的動能出現實質變化。

  • So one of the things that we look at, I'll give you a couple of data points. We have a fairly detailed Symphony model, which looks at sort of sequential share. And what we can see since the launch of ICO, the vast majority of ICO share that we see is being sourced from the two other orals in the marketplace. And that's pretty similar to what we had expected. I think the other thing, which is even more important, it's sort of a quantum measurement.

    所以我們觀察的一件事,我給你幾個數據點。我們有一個相當細緻的 Symphony 模型,用來看類似逐期(sequential)的市占。而我們可以看到,自 ICO 上市以來,我們看到的 ICO 市占絕大多數是從市場上另外兩個口服藥轉移而來。這與我們原先的預期非常相近。我認為另一件更重要的事,是某種「量子式」的衡量。

  • So just to put a fine point on it. When we can track, we can actually see our raw NBRx data in the derm and psoriasis market. And this, of course, is our new starts as well as our switching starts, classical NBRx. And when we look at the data from the launch of ICO we've absolutely seen no degradation in any of our NBRx trends. In fact, they've actually grown from the launch of ICO in March.

    所以把重點講清楚。當我們能追蹤時,我們其實可以看到在皮膚科與乾癬市場的原始 NBRx 數據。當然,這包含新起始用藥以及轉換起始用藥,也就是典型的 NBRx。而當我們看 ICO 上市後的數據,我們完全沒有看到任何 NBRx 趨勢的惡化。事實上,自 ICO 於 3 月上市以來,這些數據反而成長了。

  • So that leads to another point that's probably accurate as we continue to monitor is there still significant headroom in the moderate-to-severe psoriatic space. A large percentage of patients in the United States and around the world are still not on an advanced therapy. So we do, of course, factor in competitive dynamics into our competitive set and we'll continue to monitor. But we're quite pleased with the Skyrizi momentum, and we think it will continue given the robustness of this marketplace.

    因此也引出另一個重點:隨著我們持續監測,在中重度乾癬領域仍有顯著的成長空間(headroom)。在美國以及全球,仍有很大比例的病人尚未使用進階治療(advanced therapy)。所以我們當然會把競爭動態納入我們的競品集合並持續監測。但我們對 Skyrizi 的動能相當滿意,也認為在這個市場的強韌性之下,動能會持續。

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

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • And Chris, this is Rob. I'll just add. We always view this as a market expanding competitive launch, and that's exactly how we're seeing it. Obviously, we're still investing. I mean, I think you've seen some disease awareness investments that we've made.

    Chris,我是 Rob。我補充一下。我們一直把這視為一個「擴大市場」的競爭性上市,而我們看到的情況正是如此。顯然我們仍在持續投資。我的意思是,我想你們也看到我們做了一些疾病認知(disease awareness)的投資。

  • And so we are seeing very nice momentum continue. And I think Jeff's point that is highlighting here that we're actually seeing an acceleration of NBRx growth for Skyrizi since the launch of ICO just further supports our view that is more of a market-expanding opportunity.

    因此我們確實看到非常好的動能延續。而 Jeff 剛才強調的一點——自 ICO 上市以來,我們其實看到 Skyrizi 的 NBRx 成長加速——更進一步支持我們的看法:這更像是一個擴大市場的機會。

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

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

  • Chris, it's Roopal regarding the HS questions. We have observed other failures in the space in HS over the years. And we did our best to design two very robust studies and enrollment has gone very well. I would say training is very important for the sites. Patient selection is very important to make sure you're picking up moderate and severe disease.

    Chris,我是 Roopal,關於 HS 的問題。過去幾年我們在 HS 領域觀察到其他失敗案例。我們已盡最大努力設計兩項非常穩健的研究,且收案進展非常順利。我會說,對研究中心的訓練非常重要。病人篩選也非常重要,以確保納入的是中度與重度疾病。

  • As we look at the distinction between Luti and Rinvoq, the Lutikizumab studies are enrolling patients that were naive to advanced therapies or biologics, along with those that had failed, for example, let's say, anti-TNFs. And the primary endpoint there is high score 75 so of more stringent endpoint while including more naive patients. When we look at the Rinvoq design, that is coming post biologics.

    在看 Luti 與 Rinvoq 的差異時,Lutikizumab 的研究收納對進階治療或生物製劑(biologics)尚未使用過(naive)的病人,以及曾治療失敗的病人,例如抗 TNF。其主要終點是 HiSCR 75,因此是在納入較多 naive 病人的同時,採用更嚴格的終點。而我們看 Rinvoq 的設計,則是生物製劑之後(post biologics)。

  • So for example, post HUMIRA. And given that, that's 100% after -- that one has a high score 50, and we'll have secondary endpoints that will look at High Score 75. So these are things that we are doing to manage the trial outcomes to ensure a high -- as high a probability of success as we can. And how I describe the eligibility criteria for these two trials will be our go-to-market strategy, which is very consistent with what we have executed, I would say, very well.

    例如在 HUMIRA 之後。在此情況下,那項試驗是 100% 在……之後——那一項的主要終點是 HiSCR 50,並會有次要終點觀察 HiSCR 75。這些都是我們為了管理試驗結果、盡可能確保高——也就是盡可能高的成功機率——所做的設計。而我對這兩項試驗納入標準的描述,也將會是我們的上市策略(go-to-market strategy),這與我們過去的執行方式非常一致,我會說我們執行得很好。

  • Jeff's team has done a fantastic job in IBD with Skyrizi and Rinvoq and something similar is how we're thinking here where Luti, based on the robust safety profile we observed in Phase 2, along with strong efficacy, could allow that to be in earlier lines of patients and Rinvoq as we've seen over the years across multiple indications, works well as a later line after advanced therapy. So based on those designs, you would see a similar profile in the market with those two agents just like you've seen very successfully in IBD.

    Jeff 的團隊在 IBD 領域推動 Skyrizi 與 Rinvoq 做得非常出色;我們在這裡的思考也類似:Luti 基於我們在第二期觀察到的穩健安全性特徵,加上強勁療效,可能使其可用於較前線的病人;而 Rinvoq 如同我們多年來在多個適應症所見,在進階治療之後作為後線治療表現良好。因此基於這些設計,你會在市場上看到這兩個藥物呈現類似的定位輪廓,就像你在 IBD 領域非常成功所看到的一樣。

  • 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

  • [Michael Yee, UBS].

    [Michael Yee,瑞銀(UBS)]。

  • Michael Yee - Analyst

    Michael Yee - Analyst

  • Thank you. Maybe just pivoting away from Immunology for one second. Can you just talk a little bit about your expectations on Tavapadon launch ultimately and how you see this playing out? And what could be a slow start, fast start. Maybe just talk a little bit about how you think about that.

    謝謝。也許先暫時從免疫學轉開一下。能否談談你們對 Tavapadon 最終上市的預期,以及你們認為會如何發展?以及什麼情況可能是慢起步、快起步?請稍微談談你們如何思考這件事。

  • And then similarly, in CNS, which you've talked a lot about seeking to grow. You also have a brain shuttle as well. And I just wanted to understand a little bit about how you think that's differentiated as there's obviously a lot of interest here given what's going on in Alzheimer's. Thank you.

    另外同樣在 CNS,你們談了很多想要成長。你們也有 brain shuttle。我想更了解你們認為它的差異化在哪裡——顯然在阿茲海默症目前的發展之下,這裡有很多關注。謝謝。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah, thanks for the question. I'm glad you brought up Tavapadon because it's a key piece of our overall long-term strategy for growth in Parkinson's, as I highlighted in my remarks. Tavapadon is a very, very unique product. There's nothing else like it in the marketplace.

    好的,謝謝你的問題。我很高興你提到 Tavapadon,因為如我在發言中強調的,它是我們在帕金森氏症長期成長整體策略中的關鍵一環。Tavapadon 是一個非常、非常獨特的產品。市場上沒有其他類似的產品。

  • It's the first selective D1/D5 agonist. And obviously, we'll have both a monotherapy indication as well as an add-on to Levodopa, Carbidopa orals, the standard of care. And it's quite remarkable data that we see. Certainly, one of the most impressive dynamics that the thought leaders are very excited about is after 85 weeks of long-term utilization of Tavapadon more than 90% plus of patients don't need to basically increase their dose of Levodopa, Carbidopa. So essentially, it kind of pauses the motor dysfunction, which is really, really critical.

    它是第一個選擇性 D1/D5 促效劑(agonist)。而且很明顯地,我們將同時擁有單藥治療(monotherapy)適應症,以及作為 Levodopa、Carbidopa 口服標準治療的加成用藥(add-on)。我們看到的數據相當令人驚豔。當然,思想領袖非常興奮、認為最令人印象深刻的動態之一是:在長期使用 Tavapadon 85 週之後,超過 90% 以上的病人基本上不需要增加 Levodopa、Carbidopa 的劑量。所以本質上,它有點像是讓運動功能障礙暫停,這點非常、非常關鍵。

  • And there's a belief that, that, of course, will then spare the dyskinesia. That's just the hallmark of what happens over time. So it's very impressive. The other thing that's impressive and very distinctive is low -- very low rates of sedation or so-called sleep attacks, which are very challenging in this population, low rates of edema and really impulse control disorder. So that profile of efficacy and safety and distinctiveness is quite attractive.

    而且有一種看法是,當然,這樣就能避免異動症。那正是隨著時間推移所發生情況的典型特徵。所以非常令人印象深刻。另一個同樣令人印象深刻且非常獨特的是鎮靜或所謂睡眠發作的發生率很低——非常低;在這個族群中那是非常棘手的問題;另外水腫的發生率也低,且衝動控制障礙確實也低。因此,這種療效與安全性兼具、且具差異化的特徵相當吸引人。

  • Now to get to the nub of your question, we do see that the ramp will be modest at first, and I'll tell you why. It's not the profile of the medication. It's largely because based on the timing of the approval, we will not be immediately added into the Medicare formularies. That's going to take some more time based on the way those negotiation works, et cetera. But nonetheless, we believe that this will be a substantial addition to the marketplace and a clear contributor to that greater than $5 billion dollar peak potential. So lots of excitement for Tavapadon.

    現在回到你問題的核心,我們確實看到一開始的爬坡會比較溫和,我來說明原因。這不是藥物本身的特徵所致。主要是因為依照核准的時間點,我們不會立刻被納入 Medicare 的處方集(formulary)。依照那些協商運作方式等,這還需要一些時間。但即便如此,我們相信這將會是市場上的一項重大補充,並且會明確貢獻於超過 50 億美元的峰值潛力。所以大家對 Tavapadon 都非常興奮。

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

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

  • And Michael, it's Roopal regarding the 1758 or the Aliada asset. So that has now entered into 1B setting, so patients who have disease and the molecule was built to have an extended half-life, and we've observed that with the PK data in the first-in-human studies. The other thing we wanted was a better cerebrospinal fluid penetration than we saw with a naked antibody, which, let's say, is around 0.1%, 0.2%. This is over 1%, so several fold higher. So the transport is working.

    Michael,我是 Roopal,來回應 1758 或 Aliada 資產的問題。它現在已進入 1B 試驗情境,也就是納入已患病的病人;而且這個分子在設計上就是要有延長的半衰期,我們在首次人體(first-in-human)研究的藥物動力學(PK)數據中也觀察到了。我們想要的另一點,是比我們在裸抗體上看到的更好的腦脊髓液(CSF)穿透率;裸抗體大概只有 0.1%、0.2%。而這個超過 1%,高出好幾倍。所以運輸機制正在發揮作用。

  • So if we're able to get more into the CSF and an extended half-life and you can take down plaque and specifically, this is targeting Abeta, the pyroglutamate type, which we think is the more toxic species. We think that could set up a potential for a subcutaneous agent that could be dosed monthly. So we're looking for simplicity in the patient experience. So I would say by next year, we should start seeing data in scans to see if we can clear the brain as much as possible. And if we see that, this would rapidly move.

    因此,如果我們能讓更多藥物進入 CSF、同時具備延長半衰期,並且能降低斑塊;而且特別是它鎖定的是 Aβ 的焦谷氨酸(pyroglutamate)型態,我們認為那是更具毒性的物種。我們認為這可能為一種可皮下注射、可每月給藥一次的藥物奠定潛力。所以我們在病人使用體驗上追求簡化。因此我會說,到明年我們應該會開始看到影像掃描的數據,以確認我們是否能盡可能清除腦部。如果我們看到那樣的結果,這個計畫就會快速推進。

  • And in parallel, we're also working on our anti-tau program utilizing siRNA and the same shuttle technology. What we've observed today is mostly intrathecal approaches. We think that can be challenging. And if we can deliver an siRNA using similar technology with -- from Aliada, that could be another benefit.

    同時,我們也在推進抗 tau 計畫,使用 siRNA 與相同的穿梭(shuttle)技術。我們目前看到的大多是鞘內(intrathecal)給藥的方式。我們認為那可能具有挑戰。而如果我們能用與 Aliada 類似的技術來遞送 siRNA,那可能會帶來另一項優勢。

  • Ultimately, down the road, I think everyone has commented on this to approach Alzheimer's will likely require a combination approach. And I would say AbbVie is well positioned to go after this and hopefully, one day help as many patients as possible.

    最終,從長遠來看,我想大家都提過:要處理阿茲海默症,很可能需要組合式策略。我會說 AbbVie 在這方面具備良好布局來推進這件事,並希望有一天能盡可能幫助更多病人。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

    謝謝你,Michael。接線生,請下一題。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    Mohit Bansal,富國銀行(Wells Fargo)。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Thank you very much for taking my question. So I want to come back to HS. And the biggest debate like when you talk to KOLs is that is this -- is IL-1 is simply another inflammatory mechanism for HS or it could become meaningfully superior to like IL-17 or everything that is out there also on fibrotic and all those components.

    非常感謝讓我提問。我想回到 HS。當你和 KOL 討論時,最大的爭論是:IL-1 對 HS 來說是否只是另一種發炎機制,或者它是否可能在療效上顯著優於例如 IL-17 或目前市面上其他同時涵蓋纖維化等各種組成面向的療法。

  • What evidence do today gives you confidence that Lutikizumab could be -- could actually break through the efficacy ceiling there? And then the second part on this one, same one is that how do you -- how are you managing the GLP-1 baseline use in your clinical trials because that could actually contribute to high placebo rates here? Thank you.

    目前有哪些證據讓你有信心 Lutikizumab 可能——或實際上能——突破那個療效天花板?第二部分同樣相關:你們在臨床試驗中如何管理 GLP-1 的基線使用,因為那可能會導致安慰劑反應率偏高?謝謝。

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

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

  • Yeah, thanks, Mohit. It's Roopal. Regarding the efficacy comparisons, I would say benefit-risk comparisons. So one, in the Phase 2 study with Lutikizumab, we saw very strong data, very high deltas that would position it very favorably against anti-TNFs and anti-IL-17s.

    好的,謝謝你,Mohit。我是 Roopal。關於療效比較,我會說是效益/風險的比較。第一,在 Lutikizumab 的第二期研究中,我們看到非常強的數據、非常高的差值(delta),使其相較於抗 TNF 與抗 IL-17 具有非常有利的定位。

  • We don't see fungal infections. We haven't seen flares in IBD. So we think all of that taken together creates a strong benefit/risk balance. And as I stated, you would have potentially strong data from Rinvoq as well. So that way, we would have a dual offering.

    我們沒有看到黴菌感染。我們也沒有看到 IBD 的惡化發作(flare)。因此我們認為,綜合以上因素,形成了強而有力的效益/風險平衡。而且如我所說,你也可能會從 Rinvoq 取得強勁的數據。如此一來,我們就能提供雙重選項。

  • Now when it comes to the GLP use, the trial is quite large. So if there is GLP-1 use, we would see that occurring in both arms. So if it's happening in placebo and driving up placebo responses, we would anticipate a similar effect in the active treatment arm as well. And then remember, most of these studies started a little bit before the rate of increase, I would say, with GLP-1 usage.

    至於 GLP 的使用,這個試驗規模相當大。因此如果存在 GLP-1 的使用,我們會看到它同時發生在兩個組別。所以如果它發生在安慰劑組並推高安慰劑反應,我們也預期在主動治療組會有類似影響。另外請記得,多數研究是在 GLP-1 使用率開始上升之前不久就已啟動。

  • But that being said, I think weight loss is a potential important driver of inflammation and pain in the disease and having our 295 asset, our amylin and potentially in combination with Luti is another approach that's under consideration. I've already mentioned blocking anti blocking 23 with Skyrizi and the combo with amylin in psoriasis. So I think your observations are spot on, on what's occurring, and we would like to build off of those observations even in our obesity franchise combined in our immunology franchise.

    但即便如此,我認為減重可能是此疾病中發炎與疼痛的重要驅動因素;而我們的 295 資產——我們的 amylin——以及可能與 Luti 的合併,是另一個正在考量的方向。我先前也提到以 Skyrizi 阻斷 IL-23,以及在乾癬中與 amylin 的合併。所以我認為你的觀察非常到位,確實反映了正在發生的情況;而我們也希望在肥胖產品線與免疫學產品線的結合上,進一步延伸這些觀察。

  • Operator

    Operator

  • Asad Haider, Goldman Sachs.

    Asad Haider,高盛(Goldman Sachs)。

  • Asad Haider - Analyst

    Asad Haider - Analyst

  • Great. Thanks for taking the question and congrats on the quarter. Maybe just if we can talk about oncology, Rob, I know you've said in the past that this doesn't get enough attention -- so maybe just a question on the broader oncology strategy and some of your key programs in the context of a rapidly evolving landscape where both ADCs and PD-1 VEGF programs are in high focus. So first, what are we going to learn about Temab-A in the upcoming readouts?

    很好。謝謝讓我提問,也恭喜本季表現。或許我們可以談談腫瘤領域,Rob。我知道你過去說過這部分沒有得到足夠關注——所以想問更廣泛的腫瘤策略,以及在快速演變的環境下你們的一些關鍵計畫;目前 ADC 與 PD-1/VEGF 計畫都備受關注。首先,在即將公布的讀出(readouts)中,我們會從 Temab-A 學到什麼?

  • And where do you see this ADC differentiating from others like Merck Sac-TMT or AstraZeneca's data DXd. And then related on the PD-1 VEGF compound that you licensed from RemeGen, I think Roopal, you've said that there will be some data world lung in a couple of months, and you've previously noted that you're considering accelerating that program into Phase 3 with chemo combos and ADC combos. So just any preview of what we can expect a World Lung and on your overall development strategy Thank you.

    你認為這個 ADC 相較於其他如 Merck 的 Sac-TMT 或 AstraZeneca 的 DXd 數據,差異化會在哪裡?另外,關於你們從 RemeGen 授權引進的 PD-1/VEGF 複方(compound),我想 Roopal 你曾說過幾個月後在 World Lung 會有一些數據;你也先前提到正在考慮把該計畫加速推進到第三期,並與化療合併、以及與 ADC 合併。所以能否先預告一下我們在 World Lung 可以期待什麼,以及你們整體的開發策略?謝謝。

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

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

  • Thanks, Asad. It's Roopal here. So regarding our ADC portfolio, if you look for a second, and it's happened pretty quickly, we have Elahere, Emrelis and Decnupaz market. So there's three ADCs already out there. The Emrelis asset is already in second-line lung.

    謝謝你,Asad。我是 Roopal。關於我們的 ADC 產品組合,如果你稍微回顧一下,而且這進展相當快,我們已經有 Elahere、Emrelis 和 Decnupaz 在市場上。所以目前已經有三個 ADC 上市。Emrelis 這個資產已經用於肺癌二線治療。

  • So physicians are already getting experience. So in terms of differentiation, it's already starting now with Emrelis because folks are now learning about c-Met testing, and they're seeing, I would say, a really reasonable uptake in Emrelis that is exceeding our expectations. So that's the first point.

    因此,醫師們已經在累積經驗。所以就差異化而言,隨著 Emrelis 的推進,現在就已經開始了,因為大家正在學習 c-Met 檢測,而且我們看到 Emrelis 的採用率相當合理,我會說,甚至超出我們的預期。所以這是第一點。

  • And as we move on to Temab-A, as I described, we are already well into Phase 3 in combination with bevacizumab in third-line colon cancer. And Colon, which is not all that different from ovarian, which is going to get crowded. But right now, it's all chemo-based. So it's a very broad market, and we see high rates of c-MET expression in these tumors, especially in later lines. So that's going to be in an all-comer population.

    接著談到 Temab-A,如我所述,我們已經在第三線結腸癌中,與 bevacizumab 聯合治療的第 3 期試驗進行得相當深入。而結腸癌其實與卵巢癌差異不大,未來也會變得擁擠。但目前仍以化療為主。因此這是一個非常廣泛的市場,而且我們在這些腫瘤中看到很高比例的 c-MET 表達,尤其是在後線治療。所以這將會是在不設限入組(all-comer)的人群中進行。

  • And recall in Phase 2 against standard of care, we saw 0% response rates with a 30% response rate with Temab-A plus BEV in that third line setting. What I mentioned earlier today was data readouts in second line CRC, a larger population, the therapy in front line and second line is similar.

    並且回想一下,在第 2 期與標準治療對照時,我們看到標準治療的反應率為 0%,而在第三線情境下 Temab-A 加上 BEV 的反應率為 30%。我今天稍早提到的是第二線 CRC 的數據讀出,那是一個更大的族群,而且一線與二線的治療相似。

  • And if we see strong data there against irinotecan, we're trying to replace irinotecan. If we see higher response rates and deeper response rates, then we are positioned to move Temab-A into the front- and second-line setting, which are large markets. Now what we'll be evaluating as you get into earlier lines is how c-MET expression looks we tend to see it quite high in later lines.

    如果我們在對照 irinotecan 時看到強勁數據,我們的目標是取代 irinotecan。如果我們看到更高的反應率以及更深的反應,那麼我們就具備條件把 Temab-A 推進到一線與二線治療情境,這些都是很大的市場。而當你往更早線別評估時,我們要看的就是 c-MET 表達的樣貌;我們往往在後線看到它相當高。

  • So what that could allow us then is to have a biomarker directed approach, which, as I stated, the community and academic centers are becoming very familiar with C-met testing, and that could be a strategy in frontline and second line, and that's another layer of differentiation. Physicians want to individualize care and maximize benefit risk.

    因此,這可能讓我們採取以生物標記導向的方法;如我所說,社區與學術中心對 C-met 檢測正變得非常熟悉,而這可以成為一線與二線的策略,並形成另一層差異化。醫師希望能個人化治療並最大化效益/風險。

  • And how that can occur in oncology with ADCs is first, we optimize the dose, select the right patients and then deliver a biomarker to the field so they can do exactly that as individualized care. So I would say these are distinctions that will further differentiate. Now we're also studying in head and neck, as I described, and ovarian, and we're positioned as those data read out to move into Phase 3.

    而在腫瘤學中,ADC 要做到這點的方式是:首先最佳化劑量、選對病人,接著把生物標記帶到臨床端,讓他們能以個人化照護的方式做到這些。所以我會說,這些差異將進一步拉開差距。另外,如我所述,我們也在頭頸癌與卵巢癌進行研究,並且在這些數據讀出後,具備推進到第 3 期的條件。

  • I would say, in particular, in ovarian, we know ovarian already in the FR alpha space. And if we do a C-MET directed approach in ovarian, that would be highly distinctive and differentiated from everyone else , let's say, majority pursuing FR alpha, we see little overlap between the two biomarker approaches.

    我會說,特別是在卵巢癌方面,我們知道卵巢癌在 FRα 領域已經很成熟。如果我們在卵巢癌採取 C-MET 導向的方法,那將會非常獨特,並且與其他人(例如多數人追逐 FRα)形成明顯差異;我們看到這兩種生物標記策略之間的重疊很少。

  • So another individualized approach. And if I step back further and look at the work that we're doing in lung with Temab-A, we're exceeding efficacy levels that we saw with Emrelis. So combinations in the frontline are going to be very important. And that's where PD-1 VEGF can come in and as we're establishing that early on, and you'll see that at World Lung, what you'll see is response rates and PFS in lung. And we anticipate seeing a very competitive profile when it comes to efficacy, tolerability, safety.

    所以這又是一種個人化的方法。再退一步看我們在肺癌用 Temab-A 所做的工作,我們的療效水準已經超過我們在 Emrelis 看到的。因此,一線的聯合治療將非常重要。而這正是 PD-1 VEGF 可以切入之處;我們正在早期建立這一點,你們會在 World Lung 看到,在肺癌中你們將看到反應率與 PFS。我們預期在療效、耐受性與安全性方面會呈現非常具競爭力的特徵。

  • And we think at this stage, if we have optimized dosing and we get concordance with regulators, we can move into Phase 3 very rapidly as a chemo combo. And then in parallel, start testing our ADCs in combination with that PD-1 VEGF across tumor types. So that would include lung as we already stated and also potentially ovarian amongst other tumor types.

    我們認為在這個階段,如果我們已最佳化劑量並與監管機構達成一致,我們可以非常快速地以化療聯合方案推進到第 3 期。同時,並行啟動在不同腫瘤類型中,測試我們的 ADC 與該 PD-1 VEGF 的聯合治療。因此這將包括我們已提到的肺癌,也可能包括卵巢癌等其他腫瘤類型。

  • I don't want to take up too much time, but 706 and SEZ6 is our ADC, which has shown very strong data in small cell lung cancer. That's in Phase 3 now. And I'll highlight our PSMA steep bispecific antibody 969 showed very strong data at ASCO, and that one is now well positioned to start moving into Phase 3 into prostate cancer and can be very competitive and will not have all the logistical challenges of radioligand therapy. So that's a snapshot, I would say, much more to come, and we're very excited about this portfolio in oncology.

    我不想占用太多時間,但 706 與 SEZ6 是我們的 ADC,在小細胞肺癌中顯示非常強勁的數據。目前已進入第 3 期。另外我想強調,我們的 PSMA 陡峭雙特異性抗體 969 在 ASCO 展示了非常強的數據,現在也已具備條件開始推進到前列腺癌的第 3 期,且具備很強的競爭力,並且不會有放射性配體治療(radioligand therapy)的各種物流挑戰。所以這是一個概覽;我會說後續還有很多內容,我們對這個腫瘤產品組合感到非常振奮。

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    David Amsellem,Piper Sandler。

  • David Amsellem - Senior Research Analyst

    David Amsellem - Senior Research Analyst

  • Thanks. So in light of your comments on Rinvoq in AA and Vitiligo, particularly regarding Vitiligo, just how do you square your expectations in terms of peak with an increasingly crowded development landscape, inclusive of other agents like IL-15 and CD-122. So that's number one. And then maybe switching gears to bretisilocinin the psychodelic/neuroplastogens, how are you thinking about positioning of that agent?

    謝謝。因此,鑑於你對 Rinvoq 在 AA 與白斑症(Vitiligo)的評論,特別是白斑症方面,在研發版圖愈來愈擁擠、也包含 IL-15 與 CD-122 等其他藥物的情況下,你如何調和你對峰值(peak)的預期?這是第一點。接著也許換個話題談 bretisilocinin 這類迷幻劑/神經可塑性促進劑(psychedelic/neuroplastogens),你們如何思考該藥物的定位?

  • I know there's a lot of development work ahead, but I wanted to get your thoughts on positioning, particularly in light of the recent MDD data for Definiums form ofLSD so, if you could comment on that would be helpful. Thank you.

    我知道前面還有很多開發工作要做,但我想聽聽你對定位的看法,特別是考量到近期 Definiums 的 LSD 形式在 MDD 的數據;如果你能評論一下會很有幫助。謝謝。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah, I'll take the Vitiligo question. It's Jeff. What we've seen, and I think the whole world has seen this over time is that these immunology markets are amazingly resilient and very expansive once these technologies come in. And I think we've seen that over and over and we've talked about how years ago, you start to establish immunology segment and then you start getting second line, third line, these are lifelong conditions. And I think the first key piece is Vitiligo, obviously there's no systemic treatments approved.

    好的,我來回答白斑症的問題。我是 Jeff。我們看到的、我想全世界也長期看到的是:一旦這些技術進來,這些免疫學市場的韌性驚人,而且規模會非常擴張。我們一再看到這種情況,也談過多年前你先建立免疫學分部,接著就會出現二線、三線;這些都是終身性疾病。我認為第一個關鍵點是:白斑症顯然目前沒有任何核准的全身性治療。

  • We will be the first. So in terms of that dynamic around being particularly effective for the higher body surface areas, which are quite common and obviously, the topical is just they don't make sense there, particularly if they're active. It's just very difficult to manage creams. And when you look at the efficacy that we start to see, particularly in the longer-term extensions that just builds over time the ability to really systematically clear the skin is quite striking.

    我們將會是第一個。因此,就「對較高體表面積(BSA)患者特別有效」這個動態而言,這類患者其實相當常見,而外用治療在那種情況下顯然不合理,特別是若病灶仍在活動期。要管理乳膏治療非常困難。而當你看到我們開始觀察到的療效,特別是在較長期的延伸試驗中,效果會隨時間累積,能夠真正以系統性方式清除皮膚病灶,這點相當令人印象深刻。

  • So that gives us a significant amount of confidence. And in terms of how these markets will cascade and our ability to manage it. Plus, we have an extremely strong position I mentioned in my remarks that we've already started to expand our -- essentially our Rinvoq sales force. So our ability to bring multiple indications with long-term safety data across the Board, whether it's atopic dermatitis, alopecia, vitiligo, we'll have, I think, an exceptionally strong position to lead this emergence of the vitiligo market. So that's how we see it. I'll let Roopal handle the bretisilocindynamic.

    因此這讓我們非常有信心。至於這些市場將如何擴散,以及我們管理的能力。此外,我們也具備非常強的布局;我在發言中提到,我們已經開始擴編——基本上是擴大我們的 Rinvoq 銷售團隊。因此,我們有能力在各適應症上帶來多項適應症,並提供跨適應症的長期安全性數據,不論是異位性皮膚炎、圓形禿、白斑症;我認為我們將具備極強的地位來引領白斑症市場的興起。這就是我們的看法。我會讓 Roopal 來回答 bretisilocin 的相關動態。

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

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

  • Hey, David, it's Roopal. And regarding vitiligo and alopecia areata, the head start is very beneficial. And at this stage, we don't know how all the other assets will play out in terms of longer-term safety and efficacy. Rinvoq is very well characterized with well over a decade of safety data, and the familiarity already exists in atopic derm and it will build further with alopecia areata and vitiligo. And then we also anticipate improving improvement in efficacy over time.

    嗨,David,我是Roopal。關於白斑症與圓形禿,搶先起跑非常有利。而在這個階段,我們還不清楚其他所有資產在較長期安全性與有效性方面會如何發展。Rinvoq 的特性已被充分描繪,擁有超過十年的安全性資料;而且在異位性皮膚炎領域已具備既有的熟悉度,並將隨著圓形禿與白斑症進一步建立。此外,我們也預期隨時間推移有效性會持續改善。

  • So that's to add to Jeff's comments. And then on bretisilocin, several areas of differentiation. One is the short time of the experience. Majority of the patients within two hours are ready to leave the clinic. So I think that's one advantage.

    以上是補充 Jeff 的評論。接著談 bretisilocin,它有幾個差異化面向。其中之一是體驗時間很短。多數病人在兩小時內就可以準備離開診所。所以我認為這是一項優勢。

  • The second advantage, I would say, is the experience itself, where with bretisilocin is described as visual and a rich experience some of these other assets that are being developed that are being developed can be quite intense. Some have described them as unpleasant and distressing. The clinics with some of these assets will observe loss of consciousness where a patient becomes unresponsive. So that's not something that we have observed with bretisilocinalong with that short duration of effect.

    第二個優勢,我會說是體驗本身;bretisilocin 被描述為具視覺性、且是豐富的體驗,而其他一些正在開發的資產可能相當強烈。有些人形容它們令人不適、造成痛苦與焦慮。使用其中部分資產的診所會觀察到失去意識,也就是病人變得沒有反應。但這並不是我們在 bretisilocin 上所觀察到的情況,同時它的作用持續時間也很短。

  • The other notable mechanistic quality is the fact that it's antagonistic at 5HD 2B and many of the others are still agonistic at that receptor. And recall, that's the receptor where you see cardiovascular toxicity, specifically with thickening of cardiovascular of the valves and regurgitation.

    另一個值得注意的機轉特性是:它在 5HD 2B 受體上具有拮抗作用,而許多其他藥物在該受體上仍是致效作用。請記得,這個受體與心血管毒性相關,特別是心臟瓣膜增厚與逆流。

  • So we don't see that as a problem, which could set up the potential for chronic use. And we are under study with MDD and also considering PTSD and amongst others. So hopefully, that gives you a good sense of why we like this asset and how it can be differentiated once hopefully it gets to market.

    因此我們不認為那會是問題,這也可能為慢性使用奠定潛力。我們目前正在進行 MDD 的研究,也在考慮 PTSD 等其他適應症。希望這能讓你更清楚我們為何喜歡這項資產,以及一旦(希望)上市後它如何實現差異化。

  • Operator

    Operator

  • Luisa Hector, Berenberg.

    Luisa Hector,Berenberg。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • Hello, thank you for taking my question. I wonder if you can give us any kind of early indication from formulary season, I'm hearing levels of confidence as usual on Skyrizi, Rinvoq just sort of checking around pricing environment and impact their head-to-head studies from competitors? And then just a quick check post the announcement of Apogee. Did you prioritize any of your own pipeline assets in AD around that time in connection with Apogee. Thank you.

    你好,謝謝讓我提問。我想請問你們是否能從處方集季(formulary season)提供任何早期訊號;我聽到市場對 Skyrizi、Rinvoq 的信心程度一如往常,只是想確認一下定價環境,以及競品頭對頭研究對它們的影響?另外也快速確認一下,在宣布 Apogee 之後。你們是否在那段時間、與 Apogee 相關地,優先排序了你們在 AD(異位性皮膚炎)領域的自有研發管線資產?謝謝。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah, thank you for the question. It's Jeff. And I would say that the progression of our discussions with payers, we obviously are in contracting season here. That typically starts in the early spring.

    好的,謝謝你的問題。我是 Jeff。我會說,我們與支付方的討論進展——顯然我們現在正處於簽約季。這通常在早春開始。

  • It seems like it starts earlier and earlier. But I would say we're while these negotiations are always tough negotiations with the payers. I would say they're relatively consistent, very consistent with what we've seen over the years.

    看起來一年比一年更早開始。但我會說,雖然這些與支付方的談判一向都很艱難,整體而言與我們多年來看到的情況相當一致、非常一致。

  • As you know, we've highlighted before that particularly in immunology that this is a volume-driven business, and we see sort of low single-digit concessions around rebates and price concessions as the standard, and our position really hasn't changed from that standpoint. So we are -- continue to be encouraged with how things will play out. We're not done yet, obviously. But we have a very strong capability here and our consistency should be appreciated.

    如你所知,我們之前強調過,特別是在免疫學領域,這是一個以量驅動的業務;我們看到回扣與價格讓利方面的標準大致是低個位數的讓步,而從這個角度來看,我們的立場並沒有真正改變。因此,我們——仍然對事情的發展感到鼓舞。當然我們還沒談完。但我們在這方面具備非常強的能力,而我們的一致性應該會被肯定。

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

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

  • Luisa, it's Roopal and also on the head-to-head question, what we've observed over time with these head-to-head against Skyrizi the data gap closes over time. So you see less and less of a separation. And clinicians really like the safety profile in patients like the quarterly dosing. So there's going to be continued strong demand for Skyrizi.

    Luisa,我是 Roopal。關於頭對頭的問題,我們長期觀察到,這些與 Skyrizi 的頭對頭數據差距會隨時間縮小。所以你會看到差異越來越小。而臨床醫師非常喜歡其安全性概況,病人也喜歡每季一次的給藥。因此 Skyrizi 仍將持續有強勁需求。

  • And on the question on our own atopic dermatitis assets, I would say we are running all of them in parallel and as quickly as we can. Obviously, we want to move the anti-IL-13 as quickly as possible and whatever we can do to help that post deal closure, we're going to do that. And we are in the clinic with our 1331 bispecific and should be shortly in the clinic with a 1318 bispecific in atopic dermatitis and then potentially even asthma.

    至於我們自有的異位性皮膚炎資產,我會說我們正讓它們全部並行推進,並盡可能加快速度。顯然,我們希望盡快推進抗 IL-13;在交易完成後,任何能協助加速的事情我們都會做。此外,我們的 1331 雙特異性抗體已在臨床中,且 1318 雙特異性抗體在異位性皮膚炎上也應該很快會進入臨床,之後甚至可能延伸到氣喘。

  • And then there's a 31 monoclonal that's coming with Apogee, and that's something else that we want to test as well. And all of these assets that we've mentioned are going to be long acting. So it will -- if they can deliver the efficacy that we want to see, we will also be able to deliver that convenience to patients as well.

    另外,Apogee 還有一個 31 單株抗體即將到來,這也是我們想要測試的項目。而我們提到的所有這些資產都將是長效型。因此——如果它們能提供我們希望看到的療效,我們也能同時為病人帶來那樣的便利性。

  • Operator

    Operator

  • Matt Phipps, William Blair.

    Matt Phipps,William Blair。

  • Matt Phipps - Analyst

    Matt Phipps - Analyst

  • I want to ask about AbbVie’s 859, the oral IL-23 receptor inhibitor. You talked a little bit about I could tie coming into the market. How do you see the differentiation for 859 and maybe how you'll position it across other indications.

    我想問 AbbVie 的 859,也就是口服 IL-23 受體抑制劑。你們稍早談到一些口服藥進入市場。你們如何看待 859 的差異化,以及可能如何在其他適應症上定位它?

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

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

  • Thanks, Matt. It's Roopal. So what we liked preclinically about this asset was the potency. And if that can play out that may be a way to allow the dose to be a little bit higher and to get much better coverage. Right now, when we see how Skyrizi provides coverage, it's much, much deeper and we see higher responses than the oral and many other assets.

    謝謝,Matt。我是 Roopal。我們在臨床前喜歡這項資產的一點是它的效力(potency)。如果這能在臨床上實現,可能就能讓劑量推得更高一些,並取得更好的覆蓋。目前我們看到 Skyrizi 的覆蓋更深、更深,而且反應率也高於口服藥與許多其他資產。

  • And we think that could be potency and how high you can push the dose that's still tolerated by the patient and still needs to make sense from a cost of goods standpoint. That's one aspect. The second aspect is around half-life. Many of our orals will have short half-lives. And if you have a drop what we call Cmin, that's when the concentration reaches a low, you could be losing efficacy.

    我們認為這可能與效力有關,以及你能把劑量推到多高、同時仍能被病人耐受,並且從製造成本(cost of goods)的角度仍然合理。這是一個面向。第二個面向是半衰期。我們許多口服藥的半衰期都很短。如果出現我們所稱的 Cmin 下滑,也就是濃度降到低點時,你可能會失去療效。

  • So with this one, we have a design element that allows for an extension of half-life -- and we'll start seeing that data, I would say, next year to see if we do see an extended duration of half-life that could exceed a day or two or even further and if you have that, you can have much better coverage, potentially drive higher efficacy where we would like to get it, hopefully, closer and closer to Skyrizi.

    因此在這個項目上,我們加入了一個設計元素來延長半衰期——我們大概明年會開始看到相關數據,看看是否真的能看到半衰期延長,可能超過一天或兩天,甚至更久;如果能做到,你就能有更好的覆蓋,並可能推動更高的療效,朝我們希望的方向前進,期望能越來越接近 Skyrizi。

  • And could there be -- the question mark still remains is could there be a question here, you may not require daily dosing if the half has extended long enough, could you run in quickly in a starter pack, and could you even take this once a week. And that's something we've observed preclinically. Now we'll have to see if it plays out in humans and that those studies are kicking off imminently.

    另外仍有一個問號是:如果半衰期延長得夠久,是否就不需要每日給藥?是否可以在起始包(starter pack)中快速達到目標,甚至可以每週服用一次?這是我們在臨床前所觀察到的。現在我們必須看看在人類身上是否也能成立,而這些研究即將啟動。

  • Operator

    Operator

  • Louise Chen, Scotia Bank

    Louise Chen,豐業銀行

  • Louise Chen - Analyst

    Louise Chen - Analyst

  • Hi, thanks for taking my question. I wanted to ask you on Skyrizi subcutaneous. If you get this approved in the fall, do you expect that to drive an acceleration of sales in the second half of the year for Skyrizi? And then on the runway for exclusivity for Skyrizi beyond 2033, any update there? Thank you.

    嗨,謝謝讓我提問。我想請教關於 Skyrizi 皮下注射(subcutaneous)。如果你們在秋季獲得核准,是否預期這會帶動 Skyrizi 在下半年銷售加速?另外,關於 Skyrizi 在 2033 年之後的獨占期(exclusivity)延伸跑道,有沒有最新進展?謝謝。

  • Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

    Jeffrey Stewart - Executive Vice President, Chief Commercial Officer

  • Yeah, thanks for the question. It's Jeff. Like we do expect a meaningful acceleration for Skyrizi because of this. And if you think about it, right, the number one market value driver in IBD is efficacy on these stringent endpoints we talked about, like endoscopic response, endoscopic healing.

    好的,謝謝你的問題。我是 Jeff。我們確實預期 Skyrizi 會因此出現顯著的加速成長。而且如果你想一下,在 IBD 領域,第一大市場價值驅動因素是我們談到的那些嚴格終點上的療效,例如內視鏡反應、內視鏡癒合。

  • And the whole aspect over the subcu induction, it allows a certain segment of physicians to not have to work across two different reimbursement channels like Part B or a medical channel and then a pharmacy channel for the subcu. So in that sense, it's convenient. So when we look at our data that Roopal and I highlighted, if you look at the availability of that induction, you're sort of hitting on all of the market value drivers.

    至於皮下誘導治療(subcu induction)這一點,它讓某一部分醫師不必在兩種不同的給付/報銷通路之間來回處理,例如 Part B 或醫療通路,然後皮下則走藥局通路。因此在這個意義上,它更便利。所以當我們看 Roopal 和我剛才強調的數據時,如果你看誘導治療的可及性,你基本上是同時命中了所有市場價值驅動因素。

  • So very strong efficacy and the stringent endpoints. More convenience on induction. So certain segments don't have to work across both reimbursement channels. And then lastly, we obviously have a very strong position for our maintenance convenience. So with that -- with those three things, we are planning for an acceleration of our capture rate.

    也就是非常強的療效與嚴格終點表現。誘導治療更便利。因此某些族群不必同時跨兩個報銷通路運作。最後,我們在維持治療(maintenance)的便利性方面顯然也有非常強的優勢。所以在這三點之下,我們正規劃提升我們的市占取得率(capture rate)的加速。

  • Now having said that, it will take a month or two or a few months to sort of fully ramp up the availability based on our contracts. So we'll probably start seeing that really early in 27’. But nonetheless, our ability to start to communicate and basically highlight this innovation will come here in the fourth quarter.

    不過話說回來,基於我們的合約安排,全面拉升供應可及性大概需要一到兩個月或幾個月的時間來逐步爬坡。所以我們可能會在 27 年初真正開始看到效果。但無論如何,我們從第四季開始就能對外溝通並重點凸顯這項創新。

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

    Robert Michael - Chairman of the Board & Chief Executive Officer

  • And Louise, this is Rob. I'll take your question on the Skyrizi LOE. I mean although Skyrizi's composition matter patent expires in 2033, as you noted, we do have later expiring IP granted and in process that embodies Skyrizi's significant innovation.

    Louise,我是 Rob。我來回答你關於 Skyrizi 專利到期(LOE)的問題。如你所提,雖然 Skyrizi 的成分專利(composition of matter patent)在 2033 年到期,但我們確實擁有已獲授權以及正在申請中的、到期更晚的智慧財產權(IP),涵蓋 Skyrizi 的重大創新。

  • And this includes patents expiring in the U.S. in the mid-2030s and later. Now it's important to note, though, that regulatory data protection for Skyrizi does not expire until 2031. So we do not expect to see biosimilar application filings until the end of this decade. Obviously, we have a strong track record of vigorously defending our patents and protecting our innovation, and I would expect that to continue.

    其中包括在美國於 2030 年代中期及更晚到期的專利。不過需要注意的是,Skyrizi 的法規資料保護(regulatory data protection)要到 2031 年才到期。因此我們預期直到本十年末期才會看到生物相似藥(biosimilar)的申請送件。當然,我們一向有強而有力的紀錄,會積極捍衛我們的專利並保護我們的創新,我也預期這會持續下去。

  • Operator

    Operator

  • Evan Singerman, BMO Capital Markets.

    Evan Singerman,BMO 資本市場。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Hi, I'm Malcom Hoffman on for Evan. For emraclidine, I know you had said 100 milligrams is safe and tolerable with further escalation plans -- can you speak to why you may be confident this increased dosing could translate into improved efficacy above what we had previously seen with the asset? Are you looking at receptor occupancy data? Just trying to get a sense of confidence here.

    嗨,我是代 Evan 出席的 Malcom Hoffman。關於 emraclidine,我知道你們先前提到 100 毫克是安全且耐受,並且有進一步加量的計畫——你能談談為什麼你們有信心提高劑量可能會轉化為比我們先前在這個資產上看到的更佳療效嗎?你們是否在看受體佔有率(receptor occupancy)數據?我只是想了解一下你們信心的來源。

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

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

  • Hi, It's Roopal, I'll take that. Yes, 100 milligrams is looking good, and that will be the lowest dose that we would take forward. Next is 150 milligrams and as you stated, receptor occupancy when we noted the previous empower data sets was lower than what we would have wanted. So as we're able to increase the dose, we do anticipate much higher receptor occupancy. The other observation is PK variability even within patients.

    嗨,我是 Roopal,我來回答。是的,100 毫克看起來表現良好,而這將會是我們往後推進的最低劑量。下一個是 150 毫克;正如你提到的,我們在先前提及的 empower 數據集中看到的受體佔有率低於我們希望的水準。因此,隨著我們能夠提高劑量,我們確實預期受體佔有率會顯著提高。另一個觀察是,即使在同一位病人之內,PK(藥物動力學)也存在變異性。

  • So if we can deliver a higher dose, we're going to have a better consistent PK dose to dose and then, over time, improved receptor occupancy. We still like this profile, if we can deliver on that efficacy, we are seeing good safety. It's once a day and we're not having the GI adverse events, I think that can be quite problematic today in schizophrenia. So more to come in Phase 2 is kicking off later this year.

    所以如果我們能提供更高劑量,我們就能在每次給藥之間取得更一致的 PK 表現,並且隨時間推進提升受體佔有率。我們仍然喜歡這個特性;如果我們能在療效上達標,我們看到的安全性是良好的。它是每日一次,而且我們沒有出現 GI(腸胃道)不良事件;我認為這在當今思覺失調症治療中可能相當棘手。更多資訊後續會有,第二期試驗將在今年稍晚啟動。

  • Liz Shea - Senior Vice President, Investor Relations

    Liz Shea - Senior Vice President, Investor Relations

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

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

  • Operator

    Operator

  • This does conclude 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。您現在可以掛線。