在電話會議上,公司高層討論了強勁的銷售成長、Skyrizi 和 Rinvoq 等關鍵產品的成功,以及創新藥物管道的進展。它們解決了美容市場的挑戰、生物相似藥的競爭以及市場擴張的機會。
該公司在免疫學、腫瘤學、神經科學和美學等多個治療領域取得了進展。他們對實現關鍵治療領域的長期目標和策略成長充滿信心。
此次電話會議還涵蓋了最近的事件、收購和即將進行的試驗。總體而言,該公司專注於長期成長和創新。
使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning and thank you for standing by. Welcome to the AbbVie third quarter 2024 earnings conference call. (Operator Instructions) Today's call is being recorded.
早安,感謝您的支持。歡迎參加艾伯維 2024 年第三季財報電話會議。 (操作員說明)今天的通話正在錄音。
I would now like to introduce Mrs. Liz Shea, Senior Vice President, Investor Relations.
現在我想介紹投資者關係高級副總裁 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, Chief Executive Officer Jeff Stewart, Executive Vice President, Chief Commercial Officer Rle Thacker, Executive Vice President, Research and Development, Chief Scientific Officer Scott Rents, Executive Vice President, Chief Financial Officer and Carry Strom, senior Vice President and President Global Allergan Aesthetics.
早安.感謝您加入我們。今天與我通話的還有 Rob Michael,執行長 Jeff Stewart,執行副總裁兼首席商務官 Rle Thacker,執行副總裁,研發部,首席科學官 Scott Rents,執行副總裁、首席財務官和 Carry Strom,資深副總裁兼全球艾爾建美學總裁。
Before we get started, I'll note that some statements we make today may be considered forward-looking statements based on our current expectations. Ay 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.
在我們開始之前,我要指出的是,根據我們目前的預期,我們今天發表的一些聲明可能被視為前瞻性聲明。 Ay 警告說,這些前瞻性陳述存在風險和不確定性,可能導致實際結果與我們前瞻性陳述中所示的結果有重大差異。
Additional information about these risks and uncertainties included in our sec filings, Abby 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 Abby'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. So with that, I'll turn the call over to Rob.
有關這些風險和不確定性的更多資訊包含在我們的SEC 文件中,Abby 不承擔更新這些前瞻性聲明的義務,除非法律要求在今天的電話會議上,非GAAP 財務指標將用於幫助投資者了解Abby 的業務表現。這些非公認會計原則財務指標與我們今天發布的收益報告和監管文件中的可比較公認會計原則財務指標進行了協調一致,這些數據可以在我們準備好的評論之後在我們的網站上找到。我們會回答您的問題。因此,我會將電話轉給 Rob。
Robert Michael - Chief Executive Officer
Robert Michael - Chief Executive Officer
Thank you, Liz. Good morning everyone and thank you for joining us. Ay is performing exceptionally well and I'm extremely pleased with the execution against our strategic priorities including continued double digit sales growth from our ex Humera platform, the closing and integration of cerebral therapeutics and the progress we are making to build and advance a compelling pipeline of innovative medicines.
謝謝你,莉茲。大家早安,感謝您加入我們。 Ay 的表現非常出色,我對我們的策略重點的執行感到非常滿意,包括我們的前Humera 平台的持續兩位數銷售成長、腦治療的關閉和整合以及我們在建立和推進引人注目的管道方面所取得的進展的創新藥物。
Turning to our results, Abby's diversified portfolio delivered sales that were 260 million above our expectations and reflect robust mid single digit operational sales growth. Our ex Humer platform drove this overachievement including growth of nearly 18%.
就我們的業績而言,Abby 的多元化產品組合實現的銷售額超出我們的預期 2.6 億美元,反映出強勁的中個位數營運銷售額成長。我們的前 Humer 平台推動了這項超凡成就,包括近 18% 的成長。
The momentum of Skyrizi and Rinvoq is especially impressive with combined sales expected to exceed $17 billion this year, which is 1.3 billion above our initial expectations and we see substantial opportunity for continued strong growth well into the next decade. Several other key products also delivered double digit sales growth including Beleta Rear ubrelvy and cypto.
Skyrizi 和 Rinvoq 的勢頭尤其令人印象深刻,今年的總銷售額預計將超過 170 億美元,比我們最初的預期高出 13 億美元,我們看到了未來十年持續強勁增長的巨大機會。其他幾個主要產品也實現了兩位數的銷售成長,包括 Beleta Rear ubrelvy 和 cypto。
This broad based performance further demonstrates the strength of our commercial portfolio for the third time. This year, we are raising our full year revenue and adjusted EPS guidance. We are increasing our full year revenue guidance by $500 million and have now raised total revenue by 1.8 billion. Since our initial guidance in February, we are also raising our full year adjusted earnings per share guidance by 15¢ and now expect adjusted EPS between $10.90 and $10.94.
這一廣泛的業績第三次進一步證明了我們商業投資組合的實力。今年,我們提高了全年收入並調整了每股收益指引。我們將全年收入指引提高了 5 億美元,目前總收入已提高 18 億美元。自 2 月的初步指引以來,我們也將全年調整後每股盈餘指引提高了 15 美分,目前預計調整後每股盈餘將在 10.90 美元至 10.94 美元之間。
In addition to achieving strong quarterly results, we have been very focused on investing in the business to generate sustainable long term performance in the 2030 s and beyond. During the quarter, we successfully completed the acquisition of cerebral therapeutics, strengthening our neuroscience pipeline.
除了取得強勁的季度業績外,我們還非常注重業務投資,以在 2030 年代及以後實現可持續的長期業績。本季度,我們成功完成了腦治療藥物的收購,加強了我們的神經科學產品線。
Cerebral enhances our ability to help patients suffering from devastating conditions such as Parkinson's and Schizophrenia. The integration has been seamless and we are excited to have the talented cerebral team join our organization within the cerebral pipeline. We are very pleased with the positive phase three results and emerging profile of Tavapadon in Parkinson's and we remain on track to read out both pivotal studies for amidine in schizophrenia in the fourth quarter.
Cerebral 增強了我們幫助患有帕金森氏症和精神分裂症等毀滅性疾病的患者的能力。整合是無縫的,我們很高興有才華橫溢的大腦團隊加入我們的大腦管道內的組織。我們對 Tavapadon 治療帕金森氏症的積極第三階段結果和新的概況感到非常滿意,我們仍有望在第四季度宣讀脒治療精神分裂症的兩項關鍵研究。
More broadly on the pipeline, we have been advancing key R&D programs across all stages of development. Some notable highlights include the US approvals of V AEV for advanced Parkinson's and Botox for platysma bands. The US regulatory submission of to lio V for non squamous, non small cell lung cancer and the start of our phase two crn's platform study which is evaluating skyrizi in combination with several novel biologics.
更廣泛地說,我們一直在各個發展階段推動關鍵研發專案。一些值得注意的亮點包括美國批准用於治療晚期帕金森氏症的 V AEV 和用於治療頸闊肌帶的 Botox。美國監管機構向 lio V 提交了治療非鱗狀、非小細胞肺癌的申請,並啟動了我們的第二階段 crn 平台研究,該研究正在評估 skyrizi 與幾種新型生物製劑的組合。
In summary, Abby continues to demonstrate strong commercial operational and R&D execution. The robust performance of our growth platform once again exceeded our expectations and we see numerous opportunities to drive long term growth further underscoring our confidence in that growth. Today, we announced a 5.8% increase in our quarterly cash dividend beginning with the dividend payable in February 2025. Since inception, we have increased our quarterly dividend by more than 300%.
總而言之,艾比持續展現強大的商業營運和研發執行力。我們成長平台的強勁表現再次超出了我們的預期,我們看到了推動長期成長的眾多機會,進一步增強了我們對這種成長的信心。今天,我們宣布從 2025 年 2 月的應付股利開始,季度現金股利增加 5.8%。
With that, I'll turn the call over to Jeff for additional comments on our commercial highlights, Jeff.
接下來,我會將電話轉給傑夫,請他對我們的商業亮點發表更多評論,傑夫。
Jeffrey Stewart - Executive Vice President, Chief Commercial Officer
Jeffrey Stewart - Executive Vice President, Chief Commercial Officer
Thank you, Rob. I'm extremely pleased with the continued strong momentum across the therapeutic portfolio. I'll start with the quarterly results for immunology which delivered total revenues of more than $7 billion up 4.8% on an operational basis.
謝謝你,羅布。我對整個治療組合持續強勁的勢頭感到非常高興。我將從免疫學的季度業績開始,該季度的總收入超過 70 億美元,在營運基礎上成長了 4.8%。
Skyrizi global sales were $3.2 billion up 51.5% on an operational basis. Exceeding our expectations. We are seeing robust prescription growth across psoriatic disease with Skyrizi achieving in play biologic share leadership in approximately now 30 key countries in the US. We continue to capture nearly one out of every two in play psoriatic disease patients on biologic therapy and we see substantial room for further total share growth.
Skyrizi 的全球營業銷售額為 32 億美元,成長 51.5%。超出我們的預期。我們看到,隨著 Skyrizi 在美國目前約 30 個主要國家的生物製劑市場份額中取得領先地位,銀屑病領域的處方藥數量強勁增長。我們繼續捕獲近二分之一的銀屑病患者接受生物治療,並且我們看到總份額進一步增長的巨大空間。
We believe that Skyrizi's best in class profile with nearly complete skin clearance, high durability of response, easy onboarding and quarterly dosing for maintenance therapy sets a very high bar relative to other therapies on market or in development.
我們相信,Skyrizi 具有同類最佳的特性,具有幾乎完全的皮膚清除、高反應持久性、易於上手和維持治療的季度劑量,相對於市場上或正在開發的其他療法來說,設定了非常高的標準。
Skyrizi has also demonstrated a compelling clinical profile in IBD including strong endoscopic data paired with convenient dosing this differentiated profile as well as our compelling head to head sequence data versus Stelara is supporting very rapid uptake in Crohn's disease where Skyrizi continues to gain market share globally. Achieving in play, patient leadership across all lines of therapy in the US, Japan and Canada Skyrizi's US. In play. Patient share is now approximately 32% more than double the share of the second biologic treatment.
Skyrizi 在IBD 方面也展示了令人信服的臨床特徵,包括強大的內視鏡數據與方便的劑量相結合,這種差異化特徵以及我們與Stelara 相比令人信服的頭對頭序列數據支持克羅恩病的快速普及,Skyrizi 繼續在全球獲得市場份額。在美國、日本和加拿大 Skyrizi's US 的所有治療領域中,實現了患者的遊戲領導地位。比賽中。目前,患者所佔比例約為 32%,是第二種生物治療比例的兩倍以上。
And with Skyrizi's total prescription share of approximately 8% we see significant opportunity for revenue inflection in Crohn's going forward while we are still very early in our launch in the US and Europe, we also anticipate robust uptake for Skyrizi in ulcerative colitis. The new indication, initial prescription trends as well as feedback from gastroenterologists have been overwhelmingly positive. Physicians are particularly impressed with the data that has been demonstrated for naive patients who have not been exposed yet to biologics where Skyrizi achieved very high results for clinical remission and endoscopic response.
由於Skyrizi 的總處方份額約為8%,我們看到克羅恩病未來收入拐點的重大機會,而我們在美國和歐洲的推出仍處於早期階段,我們也預期Skyrizi 在潰瘍性結腸炎中的強勁應用。新的適應症、最初的處方趨勢以及胃腸病學家的回饋都非常積極。醫生對尚未接觸過生物製劑的初治患者所展示的數據印象特別深刻,其中 Skyrizi 在臨床緩解和內視鏡反應方面取得了非常高的結果。
We have now secured broad formulary access for Skyrizi in UC with sales in this indication expected to ramp meaningfully over the next several quarters. So given the momentum we are seeing across all of these indications, we will be raising our full year sales guidance once again for Skyrizi turning now to RVO, which is also demonstrating robust growth. Global sales were $1.6 billion up 47.4% on an operational basis.
我們現在已經在 UC 中獲得了 Skyrizi 的廣泛處方准入,預計該適應症的銷售額將在未來幾個季度大幅增長。因此,鑑於我們在所有這些跡像中看到的勢頭,我們將再次提高 Skyrizi 的全年銷售指導,現在轉向 RVO,這也顯示出強勁的成長。全球營運銷售額達 16 億美元,成長 47.4%。
We continue to see strong prescription growth across all seven of Rinvoq's approved indications. I'm especially pleased with our performance in IBD where Rinvoq's uptake is exceeding our expectations. RVO is now capturing double digit in play. Patient share in the US for ulcerative colitis as well as Crohn's disease. Both indications are now available in more than 75 countries with reimbursement and share continuing to increase.
我們繼續看到 Rinvoq 批准的所有七個適應症的處方增長強勁。我對我們在 IBD 中的表現特別滿意,Rinvoq 的採用超出了我們的預期。 RVO 現在在比賽中取得了兩位數的成績。在美國,潰瘍性結腸炎和克隆氏症患者所佔比例。這兩種適應症現已在超過 75 個國家提供,報銷和份額持續增加。
I also wanted to highlight our recent performance in atopic dermatitis where Rinvoq is seeing an acceleration of in play share following recent positive data from our second head to head study versus Dupixent as an oral option that provides rapid skin clearance and itch relief. We believe Rinvoq's strong differentiated profile will continue to compete well in this highly underpenetrated ad market as a result of this continued strong performance, we will also be increasing the full year sales guidance. Once again for RVO looking forward, we see substantial momentum for both Skyrizi and Rinvoq including continued share gains across existing indications on top of the typical underlying market growth across room derm and Gastro.
我還想強調一下我們最近在異位性皮膚炎方面的表現,在我們的第二次頭對頭研究與Dupixent 作為口服選擇提供快速皮膚清除和瘙癢緩解的近期積極數據之後,Rinvoq 看到了遊戲份額的加速。我們相信,由於持續強勁的業績,Rinvoq 強大的差異化形象將繼續在這個高度滲透的廣告市場中保持良好競爭,我們還將提高全年銷售指導。展望 RVO 的未來,我們再次看到 Skyrizi 和 Rinvoq 的強勁勢頭,包括除了 Room derm 和 Gastro 的典型基礎市場成長之外,現有適應症的份額持續增長。
Additionally, we are making excellent progress with several new indications for Rinvoq across sizable markets that will have the potential to provide another significant revenue inflection in the second half of this decade and into the 2030.
此外,我們在 Rinvoq 的幾個新適應症方面取得了巨大進展,這些適應症在相當大的市場中將有可能在本十年後半葉和 2030 年帶來另一個重大的收入拐點。
From a competitive perspective, a key element of Skyrizi. And Rinvoq's success has been their strong differentiation with compelling head to head data against several novel therapies. This includes Skyrizi's superiority versus Humira coex Otezla and Stelara in psoriasis, as well as Stelara in Crohn's disease. And Rinvoq's superiority versus Humira and Orencia in rheumatoid arthritis as well as dupixent in atopic dermatitis to further support our differentiation. We have another head to head study ongoing for Skyrizi versus SOIC in psoriasis with plans also underway now for a study comparing Skyrizi versus IV in ulcerative colitis.
從競爭的角度來看,這是 Skyrizi 的關鍵要素。 Rinvoq 的成功在於其強大的差異化能力,以及針對幾種新型療法的令人信服的頭對頭數據。這包括 Skyrizi 在治療牛皮癬方面相對於 Humira coex Otezla 和 Stelara 的優越性,以及在治療克羅恩病方面相對於 Stelara 的優越性。 Rinvoq 在類風濕性關節炎方面相對於 Humira 和 Orencia 以及在異位性皮膚炎方面相對於 dupixent 的優越性進一步支持了我們的差異化。我們正在進行另一項針對 Skyrizi 與 SOIC 治療牛皮癬的頭對頭研究,目前也計劃進行一項比較 Skyrizi 與 IV 治療潰瘍性結腸炎的研究。
So given all of these factors, we feel very confident about the long term growth prospects for both Skyrizi and Rinvoq. Turning now to Humera which delivered global sales of $2.2 billion down 36.5% on an operational basis due to biosimilar competition.
因此,考慮到所有這些因素,我們對 Skyrizi 和 Rinvoq 的長期成長前景充滿信心。現在轉向 Humera,由於生物相似藥的競爭,該公司的全球銷售額為 22 億美元,營運基礎上下降了 36.5%。
While Humira's share erosion to biosimilars in the US is largely in line with our expectations. We are now seeing more Humira molecule volume moving to other novel mechanisms than previously anticipated. So while this has an unfavorable impact to Humira sales, we are seeing a benefit to Skyrizi and Rinvoq, which is a very favorable dynamic or immunology portfolio now. And certainly over the long term moving now to oncology where total revenues were approximately $1.7 billion in Beruvia, global revenues were $828 million down 8.8% reflecting continued competitive dynamics in cll partially offset by higher persistency rates for existing patients.
而修美樂(Humira)在美國對生物相似藥的份額侵蝕基本上符合我們的預期。我們現在看到更多的 Humira 分子體積轉向其他新機制,比之前預期的要多。因此,雖然這對 Humira 的銷售產生不利影響,但我們看到 Skyrizi 和 Rinvoq 受益,它們現在是非常有利的動態或免疫學產品組合。當然,從長遠來看,現在轉向腫瘤學領域,貝魯維亞的總收入約為17 億美元,全球收入為8.28 億美元,下降8.8%,反映出cll 領域持續的競爭動態,部分被現有患者較高的持續率所抵消。
Venclexta is performing extremely well. Global sales were $677 million. Up 18.2% on an operational basis. This reflects strong momentum in CLL especially in Europe where recent guideline changes recommend combination use of NLEX plus BTK inhibitors as a preferred fixed duration treatment versus continuous BTK treatment alone growth is also supported by a very strong share position in frontline AML where Van Kle is the leading treatment for patients who are ineligible for intensive induction chemotherapy.
Venclexta 的表現非常出色。全球銷售額為 6.77 億美元。營運基礎上成長 18.2%。這反映了CLL 的強勁勢頭,特別是在歐洲,最近的指南變化建議聯合使用NLEX 加BTK 抑製劑作為首選的固定療程治療,而不是單獨連續使用BTK 治療。增長,其中Van Kle 是對於不適合強化誘導化療的患者來說,這是一種領先的治療方法。
We are also seeing nice sequential revenue growth from Ella here and at Kle which are both demonstrating strong launch trajectories. Turning now to Neuroscience where total revenues were more than $2.3 billion up 16% on an operational basis. Rlar is demonstrating robust performance sales were $875 million up 16.6% on an operational basis, reflecting continued new prescription growth in both bipolar disorder and adjunctive MDD.
我們也看到 Ella 這裡和 Kle 的營收連續成長,這都展示了強勁的發布軌跡。現在轉向神經科學,其總收入超過 23 億美元,營運收入成長 16%。 Rlar 展現了強勁的業績銷售額,在營運基礎上成長了 16.6%,達到 8.75 億美元,反映出雙相情感障礙和輔助性 MDD 的新處方持續成長。
Within migraine, our leading oral CGRP therapies contribute $445 million in combined revenue. This quarter reflecting growth of approximately 22%. As we continue to see increasing prescription demand for both Ubrelvy and CPTA Global Botox therapeutic sales were $848 million reflecting strong performance in chronic migraine as well as the other approved indications.
在偏頭痛領域,我們領先的口服 CGRP 療法貢獻了 4.45 億美元的綜合收入。本季成長約 22%。隨著我們繼續看到 Ubrelvy 和 CPTA 的處方需求不斷增加,全球 Botox 治療銷售額達到 8.48 億美元,反映出在慢性偏頭痛以及其他批准適應症方面的強勁表現。
Finally, we are very excited for the recent us approval of vi aev a transformative therapy for patients with advanced Parkinson's disease, who are uncontrolled on oral therapy alone as a less invasive nonsurgical delivery system that can provide meaningful improvements in on time and off time. We believe VEV has the potential to significantly expand use beyond current device aided therapies. Sales in the US for VEV are expected to ramp gradually over the next several quarters as we work to establish the appropriate Medicare coverage and benefit determination.
最後,我們對最近美國批准vi aev 感到非常興奮,這是一種針對晚期帕金森氏症患者的變革性療法,這些患者僅靠口服療法無法控制,作為一種侵入性較小的非手術給藥系統,可以在按時和停藥時提供有意義的改善。我們相信 VEV 有潛力大幅擴大目前設備輔助療法的使用範圍。隨著我們努力建立適當的醫療保險覆蓋範圍和福利確定,預計 VEV 在美國的銷售將在未來幾季逐漸增加。
At the same time, we are very encouraged by the interest and uptake internationally where we have approval. Now in 35 countries with several 1,000 patients already on treatment. Longer term, we anticipate peak sales of viol e to exceed $1 billion.
同時,我們對國際上對我們的認可的興趣和採用感到非常鼓舞。目前已有 35 個國家的 1,000 名患者正在接受治療。從長遠來看,我們預計 viol e 的峰值銷售額將超過 10 億美元。
So overall, I'm very pleased with the continued commercial execution and performance across the therapeutic portfolio. And with that, I'll turn the call over to Carrie for additional comments on aesthetics carry.
總的來說,我對整個治療組合的持續商業執行和表現感到非常滿意。接下來,我會將電話轉給 Carrie,以獲取有關美學攜帶的更多評論。
Carrie Strom - Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Carrie Strom - Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Thank you, Jeff third quarter, global aesthetic sales were more than $1.2 billion representing growth of 1.8% on an operational basis in the US. Aesthetic sales of $791 million increased by 3.9% driven by growth from Botox Cosmetic as well as other brands across our broad portfolio. Us, Botox cosmetic sales were $414 million an increase of 6.5% versus the prior year favorable pricing dynamics and facial toxin market growth. More than offset modest share erosion. Botox cosmetic remains the clear market leader US Tuder sales were 100 $5 million. Tubi's market leading share was consistent with last year and the overall seller market was roughly flat to the prior year.
謝謝傑夫,第三季全球美容銷售額超過 12 億美元,在美國的營運基礎上成長了 1.8%。受 Botox Cosmetic 以及我們廣泛產品組合中其他品牌成長的推動,美容銷售額達到 7.91 億美元,成長 3.9%。在美國,Botox 化妝品銷售額為 4.14 億美元,與前一年相比成長 6.5%,有利的定價動態和臉部毒素市場成長。足以抵銷適度的份額侵蝕。 Botox 化妝品仍然是明顯的市場領導者,美國 Tuder 銷售額為 100 美元 500 萬美元。 Tubi 的市場領先份額與去年持平,整體賣家市場與去年基本持平。
While the US facial injectable market remains largely stable growth is below historical rates. As a result, there is a reluctance from customers to maintain traditional toxin and filler inventory levels based upon the relatively higher price point of filler procedures in a still challenging us economic environment, Juvederm is more impacted by this dynamic which can be seen in third quarter results internationally aesthetic sales were $448 million reflecting a decline of 1.6% on an operational basis within China. The economic dynamics that weighed on our results during the first half of the year have continued to impact consumer spending.
儘管美國臉部注射市場基本上保持穩定,但成長低於歷史水準。因此,在美國經濟環境仍然充滿挑戰的情況下,由於填充程序的價格相對較高,客戶不願意維持傳統的毒素和填充劑庫存水平,喬雅登受到這種動態的影響更大,這一點可以在第三季看到國際美容銷售額為 4.48 億美元,中國境內營運銷售額下降 1.6%。上半年影響我們業績的經濟動態持續影響消費者支出。
This has created challenging aesthetic market conditions that have been particularly impactful to Juve Derm's performance. Primarily due to this circumstance, we are moderating our Juvederm sales outlook for the year. We are encouraged by the recently announced government stimulus in China. We will continue to monitor for any further developments and how it could positively impact consumer discretionary spending and aesthetic market growth.
這造成了具有挑戰性的美學市場條件,對 Juve Derm 的業績影響尤其大。主要由於這種情況,我們調整了 Juvederm 今年的銷售前景。我們對中國政府最近宣布的刺激措施感到鼓舞。我們將繼續關注任何進一步的發展,以及它如何對消費者可自由支配支出和美容市場成長產生積極影響。
Although the current dynamics in China are challenging, its potential remains attractive and we are committed to bring innovation to this market that will drive long term growth along those lines. In China. We recently received approval for the Botox Cosmetic indication and master or muscle prominence marking the first toxin in the world to have this indication.
儘管中國目前的情況充滿挑戰,但其潛力仍然有吸引力,我們致力於為這個市場帶來創新,從而推動長期成長。在中國。我們最近獲得了肉毒桿菌化妝品適應症和主肌突出症的批准,這標誌著世界上第一個具有這種適應症的毒素。
This approval enables us to market and train to this important treatment option that addresses a top aesthetic concern among many Asian patients in the US. We are pleased that we received FDA approval for the use of Botox cosmetic to treat plasma bands. This approval positions Botox as the only cosmetic toxin with four distinct indications and enables us to market and train beyond the face for the improvement of neck and jaw line appearance.
這項批准使我們能夠行銷和培訓這項重要的治療方案,解決美國許多亞洲患者最關心的美學問題。我們很高興獲得 FDA 批准使用 Botox 化妝品來治療血漿帶。這項批准使肉毒桿菌成為唯一具有四種不同適應症的美容毒素,使我們能夠在臉部之外進行行銷和培訓,以改善頸部和下巴線條的外觀。
We also remain excited about the opportunity for bont E based upon its rapid onset and short acting profile font E has the potential to activate new, new patients that are hesitant to try facial toxins. Driving long term market expansion. Looking to the future, we continue to see significant growth potential for our aesthetics portfolio based upon low market penetration rates, our commitment to introduce novel treatments, our strong customer relationships and our position as the global aesthetics leader.
我們也對 Bont E 的機會感到興奮,因為它起效快且作用時間短,Font E 有潛力激活那些猶豫是否嘗試面部毒素的新患者。推動長期市場擴張。展望未來,基於較低的市場滲透率、我們對引入新穎治療方法的承諾、我們強大的客戶關係以及我們作為全球美容領導者的地位,我們繼續看到我們的美容產品組合具有巨大的成長潛力。
With that, I'll turn the call over to Rle.
這樣,我會將電話轉給 Rle。
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Thank you, Carrie, starting with immunology where we recently began our phase two Crohn's Disease platform study which will evaluate Skyrizi in combination with several other novel biologics. This study will initially look at combinations of skyris with our anti I one alpha beta by specific li and our novel anti alpha four beta seven antibody A BBV 382. We are planning to include additional novel biologics in the future.
謝謝你,Carrie,從免疫學開始,我們最近開始了第二階段克羅恩病平台研究,該研究將評估 Skyrizi 與其他幾種新型生物製劑的組合。這項研究將首先研究 Skyris 與我們的抗 I α β by 特異性 li 和我們的新型抗 α 4 β 7 抗體 A BBV 382 的組合。
Our approach in immunology has been to pursue therapies that are well differentiated and have the potential to elevate standard of care. We have clearly achieved this with Rinvoq and Skyrizi across multiple indications including Crohn's disease and ulcerative colitis. As we think about how the IBD market will evolve, we view dual mechanism approaches as having the greatest potential to achieve levels of efficacy that are above current standard of care.
我們在免疫學方面的方法一直是尋求差異化且有可能提高護理標準的療法。我們透過 Rinvoq 和 Skyrizi 在克羅恩病和潰瘍性結腸炎等多種適應症上顯然實現了這一目標。當我們思考 IBD 市場將如何發展時,我們認為雙重機制方法最有潛力實現高於目前護理標準的療效水準。
We are very excited about the potential for these combination therapies in IBD. And we look forward to sharing updates as the data mature in oncology. We continue to make very good progress across all stages of our hem and solid tumor pipeline in the area of solid tumors. We recently submitted our application to the FDA for accelerated approval of Teleo V as a monotherapy in patients with previously treated cmet overexpressing E GFR wild type, non squamous non small cell lung cancer.
我們對這些聯合療法在 IBD 中的潛力感到非常興奮。隨著腫瘤學數據的成熟,我們期待分享最新資訊。我們在實體瘤領域的業務和實體瘤管道的各個階段繼續取得非常好的進展。我們最近向 FDA 提交了申請,要求加速批准 Teleo V 作為單一療法,用於治療先前治療過的 cmet 過度表現 E GFR 野生型非鱗狀非小細胞肺癌患者。
Once approved Talisa V will become the first cmet targeted A DC to enter non small cell lung cancer, a segment with limited options and where patients tend to have a very poor prognosis, especially if their tumors express cmet.
一旦獲得批准,Talisa V 將成為第一個進入非小細胞肺癌的cmet 靶向A DC,非小細胞肺癌是一個選擇有限的細分市場,患者往往預後很差,特別是如果他們的腫瘤表達cmet 。
We anticipate an approval decision in the first half of 2025 in the quarter, we also received a positive chmp opinion recommending here for the treatment of platinum resistant ovarian cancer in patients with high expression of FR alpha and treated with up to three prior therapies. This decision was based on the positive phase three Mirasol trial where elahe demonstrated an overall survival benefit and significantly reduced the risk of cancer progression.
我們預計將在 2025 年上半年本季做出批准決定,我們也收到了 chmp 的積極意見,建議用於 FR α 高表達且接受過最多三種既往療法的患者治療鉑耐藥性卵巢癌。這項決定是基於 Mirasol 第三階段試驗的積極結果,其中 elahe 證明了整體存活獲益,並顯著降低了癌症進展的風險。
We anticipate an approval decision in Europe in the fourth quarter. At the recent ESMO Congress, we presented new phase one data for ABBV 400 in advanced nonsmallcell lung cancer and gastroesophageal cancer early efficacy data from the lung cohort are promising with an objective response rate of 48% across all patients in the study and response rates ranging from 60 to 78% in patients with overexpressed cmet.
我們預計歐洲將在第四季做出批准決定。在最近的ESMO 大會上,我們展示了ABBV 400 在晚期非小細胞肺癌和胃食道癌中的新一期數據,來自肺部隊列的早期療效數據令人鼓舞,研究中所有患者的客觀緩解率為48%,緩解率範圍cmet 過度表現的患者中,這一比例為 60% 至 78%。
We are very pleased with the level of activity we're seeing from our next generation CMET 80 C which compares favorably to TAES OV where we've seen objective response rates ranging from 23% in medium cmet expressors to 35% in patients with high cmet expression. 400 has the potential to expand our cmet portfolio into earlier lines of therapy and lower levels of cmat expression in lung cancer.
我們對下一代 CMET 80 C 的活動量感到非常滿意,與 TAES OV 相比,我們看到客觀緩解率範圍從中等 cmet 表達者的 23% 到高 cmet 患者的 35%表達。 400 有潛力將我們的 cmet 產品組合擴展到肺癌的早期治療和較低水平的 cmat 表達。
Similarly, in patients with advanced gastroesophageal cancer, 400 demonstrated promising activity with an objective response rate of 29% across all patients. This compares well against combination and single agent chemotherapy, which are the standards of care for patients in second line and third line of therapy respectively.
同樣,在晚期胃食道癌患者中,400 名患者表現出了有希望的活性,所有患者的客觀緩解率為 29%。這與合併化療和單藥化療相比效果很好,後者分別是第二線和第三線治療患者的護理標準。
Based on these encouraging preliminary data, we plan to begin phase two studies for 400 in both non small cell lung cancer and gastroesophageal cancer recall. We've also advanced 400 in late line colorectal cancer and we remain on track to begin a phase three study later this year in the area of hematologic oncology, we received approval in Europe for Tep Kinley as a monotherapy treatment for patients with relapsed refractory follicular lymphoma. After two or more lines of therapy, epcoritamab is now the only T cell engaging bispecific approved in the US and Europe to treat both follicular lymphoma and diffuse large B cell lymphoma.
基於這些令人鼓舞的初步數據,我們計劃開始對 400 例非小細胞肺癌和胃食道癌進行第二階段研究。我們在晚期結直腸癌方面也取得了400 的進展,我們仍有望在今年稍後開始血液腫瘤學領域的第三階段研究,我們在歐洲獲得了Tep Kinley 的單一療法治療復發難治性濾泡癌患者的核准淋巴瘤。經過兩種或多種療法後,epcoritamab 現在是美國和歐洲批准的唯一一種雙特異性 T 細胞治療濾泡性淋巴瘤和瀰漫性大 B 細胞淋巴瘤的藥物。
Moving to Neuroscience, we recently received FDA approval for viol as the first subcutaneous 24 hour infusion of levodopa based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease. Our novel subcutaneous levodopa carbidopa delivery system offers meaningful benefits over current treatment options and others that are in development.
轉向神經科學,我們最近獲得 FDA 批准 viol,作為第一個基於左旋多巴的皮下 24 小時輸注療法,用於治療患有晚期帕金森氏症的成人的運動波動。我們的新型皮下左旋多巴卡比多巴給藥系統比目前的治療方案和其他正在開發的治療方案具有更有意義的優勢。
Velev delivers significant improvements in on time and off time with a nonsurgical 24 hour delivery system. It can deliver high levadopa doses similar to the amount provided by Duopa and it doesn't require combination with oral drugs to achieve efficacy. We're extremely excited to bring this transformative therapeutic option to patients in the US. We also recently announced positive top line results from the phase three Temple one trial which evaluated fixed doses of monotherapy to vapi in early Parkinson's disease.
Velev 透過非手術 24 小時輸送系統顯著改善了準時和停工時間。它可以提供與 Duopa 相似的高左旋多巴劑量,並且不需要與口服藥物組合即可達到療效。我們非常高興能為美國患者帶來這種變革性的治療選擇。我們最近也宣布了第三階段 Temple 一號試驗的積極頂線結果,該試驗評估了 vapi 單一療法治療早期帕金森氏症的固定劑量。
In the study, both doses of Tavapadon met the primary endpoint demonstrating a significant reduction in the severity of Parkinson's disease symptoms compared with placebo at week 26 as measured by decreases in the combined scores for parts two and three of the Unified Parkinson's disease rating scale, key secondary endpoints were also met in this study, we are very pleased with the emerging profile for Tavapadon which shows it is generally safe and well tolerated and it can drive strong efficacy as a monotherapy in early Parkinson's and as an adjunctive treatment in patients with more advanced disease results from the two phase three studies thus far look favorable compared to other dopamine agonist on the market. And we believe Tavapadon has the potential to become an important new treatment option as a monotherapy for Parkin Parkinson's patients as well as an adjunct to oral levo carbidopa.
在這項研究中,兩種劑量的Tavapadon 均達到了主要終點,顯示與安慰劑相比,第26 週時帕金森氏症症狀的嚴重程度顯著降低,這是透過統一帕金森氏症評分量表第二部分和第三部分的綜合評分下降來衡量的。作為早期帕金森氏症的單一療法和作為更多帕金森氏症患者的輔助治療可以帶來強大的療效。不錯。我們相信 Tavapadon 有潛力成為一種重要的新治療選擇,作為帕金森氏症患者的單一療法以及口服左旋卡比多巴的輔助療法。
We expect to see results from temple two later this year, which is our phase three monotherapy study, evaluating a flexible dose of Tapon results from our long term safety study. Tempo four are expected next year. As Rob mentioned, we remain on track to share data from the two and Mirali pivotal studies in the fourth quarter.
我們預計今年稍後會看到第二個項目的結果,這是我們的第三階段單一療法研究,評估我們長期安全性研究中靈活劑量的 Tapon 結果。預計明年推出 Tempo 4。正如 Rob 所提到的,我們仍將在第四季度分享這兩項研究和 Mirali 關鍵研究的數據。
We also continue to invest in external innovation to strengthen our Neuroscience pipeline. We recently announced two deals in this area including an expanded collaboration with Gideon Richter to develop novel targets for neuropsychiatric conditions. And the acquisition of ALIAA brings an anti pyroglutamate abeta antibody which uses a unique blood brain barrier crossing, an amyloid aggregate clearing technology.
我們也繼續投資外部創新,以加強我們的神經科學管道。我們最近宣布了該領域的兩項交易,包括與 Gideon Richter 擴大合作,開發神經精神疾病的新標靶。收購ALIAA帶來了抗焦谷氨酸abeta抗體,該抗體採用獨特的血腦屏障穿越技術,即澱粉樣蛋白聚集物清除技術。
Aa's lead antibody has been able to achieve encouraging levels in cerebrospinal fluid with an extended half life and the potential to be delivered subcutaneously. This molecule could become a best in class treatment for Alzheimer's disease.
Aa 的先導抗體已能夠在腦脊髓液中達到令人鼓舞的水平,半衰期延長,並且具有皮下輸送的潛力。這種分子可能成為治療阿茲海默症的最佳藥物。
Aad's novel technologies for enabling therapeutics to access the central nervous system also have the potential to be used with other programs across our neuroscience pipeline in aesthetics. We recently received approval for Botox in the US for moderate to severe platis bans marking the first global approval in this indication for any neurotoxin.
Aad 的新技術使治療能夠進入中樞神經系統,也有可能與我們美學神經科學管道中的其他項目一起使用。我們最近在美國獲得了對 Botox 的中度至重度 platis 禁令的批准,這標誌著全球首次批准適應症用於任何神經毒素。
There is currently a lack of nonsurgical treatments available to improve the appearance of prominent platysma bands. And we believe Botox will represent an important new treatment option for patients who are looking to reduce the appearance of vertical neck bands and improve jawline definition in our novel toxin portfolio. We remain on track to submit our regulatory application for BTI around the end of this year. Our rapid onset short acting toxin has a highly differentiated clinical profile and once approved will offer patients a novel option compared to currently available neurotoxins.
目前缺乏可用於改善突出頸闊肌帶外觀的非手術治療方法。我們相信,對於那些希望減少垂直頸帶的出現並改善我們新型毒素組合中下巴輪廓的患者來說,肉毒桿菌將成為重要的新治療選擇。我們仍有望在今年年底左右提交 BTI 監管申請。我們的速效短效毒素具有高度差異化的臨床特徵,一旦獲得批准,與目前可用的神經毒素相比,將為患者提供一種新的選擇。
So in summary, this has been a very productive year thus far for our R&D organization and we are pleased with the progress we've made advancing our broad pipeline.
總而言之,到目前為止,對於我們的研發組織來說,這是非常富有成效的一年,我們對我們在推動廣泛的產品線方面取得的進展感到高興。
With that. I'll turn the call over to Scott.
就這樣。我會把電話轉給史考特。
Scott Reents - Chief Financial Officer, Executive Vice President
Scott Reents - Chief Financial Officer, Executive Vice President
Thank you, Ruple. Starting with our third quarter results, we reported adjusted earnings per share of $3 which is 10¢ above our guidance midpoint. These results include a 4% unfavorable impact from acquired IP R&D expense. Total net revenues were nearly $14.5 billion reflecting robust growth of 4.9% on an operational basis excluding a 1.1% unfavorable impact from foreign exchange.
謝謝你,魯普爾。從第三季業績開始,我們報告調整後每股收益為 3 美元,比我們的指導中點高出 10 美分。這些結果包括來自收購的知識產權研發費用的 4% 的不利影響。總淨收入接近 145 億美元,反映出營運基礎上 4.9% 的強勁成長,排除了 1.1% 的外匯不利影響。
Our ex Humer growth platform which covers more than 80% of the total sales delivered reported growth of nearly 18%. Once again exceeding our expectations, the adjusted operating margin ratio was 46.7% of sales. This includes adjusted gross margin of 84.4% adjusted R&D expense of 14.2% acquired IP R&D expense of 0.6% and adjusted SG and a expense of 23% net interest expense was $591 million. The adjusted tax rate was 16.2%.
我們的前 Humer 成長平台涵蓋了總銷售額的 80% 以上,報告成長了近 18%。調整後的營業利益率為銷售額的 46.7%,再次超越我們的預期。其中包括調整後的毛利率 84.4%、調整後的研發費用 14.2%、收購的智慧財產權研發費用 0.6% 以及調整後的銷售費用和 23% 的淨利息費用為 5.91 億美元。調整後的稅率為16.2%。
Turning to our financial outlook, we are raising the midpoint of our full year adjusted earnings per share guidance by 15¢ and now expect adjusted earnings per share between $10.90 and $10.94. Please note that this guidance does not include an estimate for acquired IP R&D expense that may be incurred beyond the third quarter.
談到我們的財務前景,我們將全年調整後每股收益指引的中點上調 15 美分,目前預計調整後每股收益將在 10.90 美元至 10.94 美元之間。請注意,本指南不包括第三季之後可能發生的收購知識產權研發費用的估計。
We now expect total net revenues of approximately $56 billion. An increase of $500 million at current rates. We expect foreign exchange to have a 0.7% unfavorable impact on full year sales growth. This revenue forecast includes the following updates to select key products and therapeutic areas.
我們現在預計總淨收入約為 560 億美元。以當前匯率計算增加 5 億美元。我們預計外匯將對全年銷售成長產生0.7%的不利影響。此收入預測包括對選定的關鍵產品和治療領域的以下更新。
We now approximate skyrizi global sales of $11.5 billion an increase of 500 million due to continued strong performance across all approved indications RVO total revenue of $5.8 billion. An increase of 100 million reflecting robust uptake in IBD us total us Humira total sales of $7.4 billion. A decrease of 400 million reflecting more Humira molecule volume. Moving to other novel mechanisms including Skyrizi and Rinvoq.
由於所有批准適應症的持續強勁表現,我們目前預計 Skyrizi 全球銷售額為 115 億美元,增加了 5 億美元,RVO 總收入為 58 億美元。增加 1 億美元反映了 IBD 的強勁成長,美國 Humira 總銷售額達到 74 億美元。減少 4 億,反映出 Humira 分子體積增加。轉向其他新穎的機制,包括 Skyrizi 和 Rinvoq。
In Brua total revenue of $3.3 billion an increase of 200 million reflecting higher persistency rates for existing patients. Venclexta total sales of $2.6 billion. An increase of 100 million reflecting momentum in both us and international markets. Aesthetics, global revenue of $5.3 billion. A decrease of 200 million almost entirely due to lower Juvederm volume which continues to be impacted by challenging economic conditions in key markets.
Brua 的總收入為 33 億美元,增加了 2 億美元,反映出現有患者的持續率更高。 Venclexta 總銷售額達 26 億美元。增加了 1 億,反映了美國和國際市場的動能。美學,全球營收53億美元。減少 2 億美元幾乎完全是由於 Juvederm 銷量下降,而主要市場經濟形勢嚴峻,繼續影響了 Juvederm 銷售。
Our total sales of $3.3 billion. A decrease of 100 million reflecting continued strong prescription demand partially offset by modestly unfavorable channel mix. And for Botox, we now expect global revenue in the therapeutic space of $3.3 billion. An increase of 100 million reflecting robust demand across all indications.
我們的總銷售額為 33 億美元。減少 1 億,反映出持續強勁的處方需求,但部分被通路組合適度不利所抵消。對於 Botox,我們現在預計治療領域的全球收入為 33 億美元。增加 1 億,反映出所有適應症的強勁需求。
Moving to the P&L for 2024. We continue to forecast a full year adjusted gross margin of approximately 84% of sales adjusted R&D investment of 14% adjusted SG and a expense of 23.5% as well as well as an adjusted operating margin ratio of roughly 44.5% of sales, which includes a 2.1% unfavorable impact from acquired IP R&D expense.
轉向 2024 年損益表 我們繼續預測全年調整後毛利率約為 84%,調整後研發投資為 14%,調整後銷售成本和費用為 23.5%,調整後營業利潤率約為 44.5佔銷售額的百分比,其中包括收購的知識產權研發費用帶來的2.1% 的不利影響。
Turning to the fourth quarter, we anticipate net revenues approaching $14.8 billion at current rates. We expect foreign exchange to have a neutral impact on sales growth. We expect adjusted earnings per share between $2.94 and $2.98. This guidance does not include acquired IP R&D expense that may be incurred in the quarter and excludes any potential impact from the recently announced acquisition of Alliata therapeutics.
談到第四季度,我們預計以當前匯率計算淨收入將接近 148 億美元。我們預期外匯對銷售成長的影響為中性。我們預計調整後每股收益將在 2.94 美元至 2.98 美元之間。該指引不包括本季可能發生的收購知識產權研發費用,也不包括最近宣布收購 Alliatatherapys 的任何潛在影響。
Finally, Avi's robust business performance continues to support our capital allocation priorities. Our cash balance at the end of September was nearly $7.3 billion and we generated more than $11 billion of free cash flow which includes approximately $1.5 billion of skyrizi royalty payments in the first nine months of the year.
最後,Avi 強勁的業務業績持續支持我們的資本配置優先事項。截至 9 月底,我們的現金餘額接近 73 億美元,我們產生了超過 110 億美元的自由現金流,其中包括今年前 9 個月約 15 億美元的 skyrizi 特許權使用費。
This free cash flow fully supports a strong and growing quarterly dividend which we are increasing 5.8% to $1.64 per share beginning with the dividend payable in 2025 as well as debt repayment where we remain on track to pay down the roughly 7 billion of maturities this year and anticipate achieving a net leverage ratio of two times by the end of 2026.
這種自由現金流完全支持強勁且不斷增長的季度股息,從2025 年的應付股息以及債務償還開始,我們將股息增加5.8% 至每股1.64 美元,我們仍有望償還今年約70 億美元的到期債務預計到2026年底,淨槓桿率將達到兩倍。
Our strong cash flow also provides capacity for additional business development. We have executed more than a dozen early stage deals so far this year and we continue to assess external innovation across all of our key growth areas.
我們強勁的現金流也為額外的業務發展提供了能力。今年到目前為止,我們已經執行了十多項早期交易,我們將繼續評估所有關鍵成長領域的外部創新。
In closing, Abby has once again delivered strong top and bottom line results. I'm very pleased with the momentum of our ex humera growth platform including continued robust performance from Skyrizi and Rinvoq, which further supports Abby's long term outlook.
最後,艾比再次取得了強勁的營收和利潤表現。我對我們的 ex humera 成長平台的勢頭感到非常滿意,包括 Skyrizi 和 Rinvoq 的持續強勁表現,這進一步支持了 Abby 的長期前景。
With that. I'll turn the call back over to Liz.
就這樣。我會把電話轉回給麗茲。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks, Scott. We will now open the call for questions. We are aware of a peer earnings call that begins at 9 a.m. central. So we will do our best to wrap up our Q&A right around the top of the hour. So in the interest of hearing from as many analysts as possible, please limit yourself to just one question operator. First question, please.
謝謝,斯科特。我們現在開始提問。我們獲悉,同行財報電話會議將於中部時間上午 9 點開始。因此,我們將盡力在本小時結束時結束我們的問答。因此,為了聽取盡可能多的分析師的意見,請限制自己只回答一個問題操作員。第一個問題,請。
Operator
Operator
Thank you. Our first question comes from Chris shot with JP Morgan. Let me ask your question.
謝謝。我們的第一個問題來自克里斯與摩根大通的合作。讓我問你的問題。
Chris Schott - Analyst
Chris Schott - Analyst
Great. Thanks so much for the question and congrats on the results. My question was really just center around 2025 and just some preliminary outlook there. I guess a specific question you mentioned Humira volumes are maybe shifting over to newer drugs. You comment at all about just in terms of where the street sits currently with Humera. I think the consensus number is about 6.8 billion.
偉大的。非常感謝您的提問並祝賀結果。我的問題實際上只是圍繞 2025 年左右進行,並且只是一些初步的展望。我想你提到的一個特定問題 Humira 的銷售可能正在轉向更新的藥物。您對 Humera 所在街道目前的位置進行了評論。我認為共識數量約68億。
Is that a reasonable forecast or is that something you could see higher erosion given what's happening with Humira and then bigger picture kind of tied to that the mid single digit top line growth. It sounds like the trends you're seeing here may be a net positive where maybe Humira volumes are declining, but that's largely moving over to Skyrizi and RVO. I just want to get some context of, is that mid single digit target still a reasonable one to think about for the next year. Thank you.
這是一個合理的預測,還是考慮到 Humira 的情況,你可能會看到更高的侵蝕,然後更大的前景與中個位數的收入成長有關。聽起來您在這裡看到的趨勢可能是一個淨積極的趨勢,也許 Humira 的銷量正在下降,但這很大程度上轉移到了 Skyrizi 和 RVO。我只是想了解一些背景信息,中個位數目標是否仍然是明年值得考慮的合理目標。謝謝。
Robert Michael - Chief Executive Officer
Robert Michael - Chief Executive Officer
Thanks for the question, Chris. This is Rob. I'll start and then I'll have, I'll have Jeff supplement. So yes, we are very confident in that robust mid single digit growth. Both top line bottom line for 2025 I think you've interpreted correctly that the trends we're seeing are net positive and that we're seeing overperformance from Skyrizi and Rinvoq more than offsetting the dynamics with Humira.
謝謝你的提問,克里斯。這是羅布。我會開始,然後我會有傑夫補充。所以,是的,我們對強勁的中個位數成長非常有信心。我認為您對 2025 年的兩個頂線底線的解釋是正確的,即我們看到的趨勢是淨積極的,並且我們看到 Skyrizi 和 Rinvoq 的超額表現不僅僅是抵消了 Humira 的動態。
And so, you know, as we look at consensus that's probably not reflected. So I think it's fair to say there's a shift that's required there, but we're very pleased with the strong uptake for Skyris and RBO. As I mentioned in my remarks, we have now delivered guidance increases of 1.3 billion for Skyrizi and RBO. In total. We're seeing tremendous momentum, particularly with the IBD indications across really all indications, but particularly in IBD. And we are starting to see this dynamic with the overall humera molecule where there is the switching that we're seeing.
所以,你知道,當我們審視可能沒有被反映的共識時。因此,我認為可以公平地說,那裡需要進行轉變,但我們對 Skyris 和 RBO 的強勁採用感到非常滿意。正如我在演講中提到的,我們現在已為 Skyrizi 和 RBO 提供了 13 億美元的成長指引。總共。我們看到了巨大的勢頭,特別是 IBD 適應症幾乎涵蓋了所有適應症,尤其是 IBD。我們開始看到整個肱骨分子的動態變化,我們看到了這種變化。
Now to other mechanisms including Skyris RBU, which is a long term, very positive benefit. So, you know, as we look at the business, we're very well positioned, you know what essentially two years after the US loe will be returning to robust top line and bottom line growth and really performance, you know, across many parts of the business, not just Skyris Rbu, you've seen us perform very nicely in oncology. We've, you know, obviously overperformed our expectations in oncology. Very pleased with the early returns on a here, Van Kle is performing exceptionally well.
現在談談包括 Skyris RBU 在內的其他機制,這是一個長期的、非常積極的利益。所以,你知道,當我們審視業務時,我們處於非常有利的位置,你知道,基本上兩年後,美國羅伊將在許多方面恢復強勁的營收和利潤增長以及真正的業績不僅僅是Skyris Rbu,您已經看到我們在腫瘤學方面表現非常出色。你知道,我們在腫瘤學方面的表現顯然超出了我們的預期。 Van Kle 對這裡的早期回報非常滿意,表現非常出色。
The guidelines changes in Europe are positive as we think about the combination opportunities with BTK inhibitors. So Van Kle is going to be strong. Kinley is performing very nicely as well and then when I look across the Neuroscience franchise, you know, rear is a strong grower. We're very pleased with the migraine portfolio, obviously, very excited about terrible and doing a number of deals.
當我們考慮與 BTK 抑制劑的組合機會時,歐洲的指南變化是積極的。所以范克萊會變得很強大。金利的表現也非常好,當我瀏覽神經科學系列時,你知道,後部是一個強大的種植者。顯然,我們對偏頭痛投資組合非常滿意,對糟糕的交易感到非常興奮。
Now on the early pipeline, both with Gideon Richter and Aada that really fortifies the long term view for neuroscience as well. And then with aesthetics, while it's below our expectations for this year, obviously, the economic conditions have dictated that we still have tremendous confidence in the long term outlook for that business. But as we look at 2025 we're very confident in our ability to return to that robust mid single digit growth.
現在,吉迪恩·里克特 (Gideon Richter) 和阿達 (Aada) 都處於早期研發階段,這也確實強化了神經科學的長期觀點。然後是美學,雖然低於我們今年的預期,但顯然,經濟狀況表明我們對該業務的長期前景仍然充滿信心。但展望 2025 年,我們對恢復強勁的中位數成長的能力非常有信心。
Jeffrey Stewart - Executive Vice President, Chief Commercial Officer
Jeffrey Stewart - Executive Vice President, Chief Commercial Officer
Yeah, thanks Rob and I'll just add a little bit more flavor it's Jeff. So we saw this trend start to emerge in terms of this compression of the, let's say the atom molecule or the atom market that Humira plus biosimilars just prior to the CV S event. And then it accelerated over Q2. And again, we saw it throughout Q3. So that's why we, we've adapted our approach here. Other than this dynamic, the biosimilar dynamics are playing out really exactly as we anticipated.
是的,謝謝羅布,我會添加一點更多的味道,這是傑夫。因此,我們看到這種趨勢開始出現,就在 CV S 事件之前,修美樂加生物相似藥的原子分子或原子市場的壓縮。然後它在第二季度加速。我們在第三季再次看到了這一點。這就是為什麼我們在這裡調整了我們的方法。除了這種動態之外,生物相似藥的動態也完全符合我們的預期。
And you can, you can see this compression in the Aia data. So really the shrinking of the, of the Humira or the atom market is something that's, that's, that's quite clear. It's a little difficult to quantify over time with full precision, but we can see that the molecule continues to decline sequentially and we continue to see strong share gains as I highlighted for Skyrizi and Rinvoq.
您可以在 Aia 資料中看到這種壓縮。因此,修美樂(Humira)或原子市場的萎縮確實是非常明顯的。隨著時間的推移,要完全精確地量化有點困難,但我們可以看到該分子繼續連續下降,並且我們繼續看到強勁的份額增長,正如我為 Skyrizi 和 Rinvoq 強調的那樣。
So this incremental flow from the molecule compression, it's clearly a contributing factor to some of the overperformance that we saw in Q2 and Q3. But it's really only one of several. We've also had significant incremental investments in the consumer space. The salesforce approaches, we've taken Chris the integration of the head to head data I talked about and certainly now we're starting to see the impact of the UC launch. So when we, when we put all that together, we think that the dynamics are our net net quite positive overall. And as Rob said, we're still, we're still looking good for 25.
因此,分子壓縮帶來的增量流量顯然是我們在第二季和第三季看到的一些超性能的促成因素。但這其實只是其中之一。我們也在消費領域進行了大量增量投資。銷售團隊接近了,克里斯,我們已經整合了我談到的頭對頭數據,當然現在我們開始看到 UC 推出的影響。因此,當我們將所有這些放在一起時,我們認為我們的淨網整體動態非常積極。正如 Rob 所說,25 歲的我們仍然看起來很好。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thank you, Chris Operator. Next question please.
謝謝你,克里斯接線員。請下一個問題。
Operator
Operator
Thank you. And next question comes from Mohit Bezel. Your line is open. You may ask your question.
謝謝。下一個問題來自 Mohit Bezel。您的線路已開通。你可以問你的問題。
Mohit Bansal - Analyst
Mohit Bansal - Analyst
Awesome. Thank you very much for taking my question. Just wanted to touch upon the trial. You are running head to head against TV. Could you help us understand based on pre clinical or early data? What gives you confidence there? And are you looking at non inferiority or, or, or potential superiority over TV there? Thank you.
驚人的。非常感謝您回答我的問題。只是想談談審判。你正在與電視正面交鋒。您能根據臨床前或早期數據幫助我們了解嗎?是什麼給了你信心?你是否在尋找相對於電視的非劣勢或潛在優勢?謝謝。
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
A O head. It's ruple. I'll take that one. So when we look at the data, in particular, I think Jeff highlighted this in ulcerative colitis with Skyrizi in this naive patient population. This is a patient population that hasn't seen biologics or other advanced therapies like Jack inhibitors, the the endoscopic improvement and this is in label is 76% in the maintenance portion of this. So it was quite high in, in fact, higher than what we've observed even with RVO.
一個O頭。是盧布。我會接受那個。因此,當我們查看數據時,我認為 Jeff 特別強調了 Skyrizi 在這一天真的患者群體中的潰瘍性結腸炎中的這一點。這是一個尚未見過生物製劑或其他先進療法(如 Jack 抑制劑)的患者群體,內視鏡改善和標籤中的維持部分佔 76%。事實上,即使使用 RVO,它也比我們觀察到的要高。
So that gave us a good amount of confidence that we have the potential to differentiate with all other assets. You heard about the Sky Rizzy versus Eakin a head to head in Crohn's disease. But this one gives us a unique opportunity there to go head to head with Veto Liz especially looking at endoscopic improvement. So for that particular end point, you asked about the type of endpoint there, we would think about superiority because of it being an objective endpoint, sometimes with symptoms like clinical remission, these could bounce around. That may be one where we consider as non inferiority. But I would say endoscopic improvements in the field are now believed to be highly predictive of long term outcomes. So that would be how we're looking at this moment.
因此,這給了我們很大的信心,我們有潛力與所有其他資產區分開來。您聽說過 Sky Rizzy 與 Eakin 在克隆氏症方面的正面交鋒。但這給了我們一個獨特的機會,可以與 Veto Liz 正面交鋒,特別是在內視鏡改進方面。因此,對於那個特定的終點,您詢問那裡的終點類型,我們會考慮優越性,因為它是一個客觀終點,有時伴隨臨床緩解等症狀,這些可能會反彈。這可能是我們認為不自卑的一個。但我想說的是,該領域的內視鏡改進現在被認為可以高度預測長期結果。這就是我們目前的看法。
Thank you very much. Appreciate it.
非常感謝。欣賞它。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks Mohit operator. Next question, please.
感謝 Mohit 接線生。請下一個問題。
Operator
Operator
[Vamil Divan, Guggenheim Securities].
[Vamil Divan,古根漢證券]。
Vamil Divan - Analyst
Vamil Divan - Analyst
Great. Thanks for taking the question. So y'all keep it just one on M Radine. Just getting a lot of questions from investors kind of leading up to that data release. So maybe you can just for level set expectations on what you're hoping to see you know, from the data, especially obviously, now we have the approval from Bristol with just kind of what are you thinking in terms of FC safety profile relative to that competitor and also the deliverr testing requirement that they had it initiation? Is that something you'd expect as well based on your data? And then just to tie into that just in terms of the data releases, what do you expect to give one press release or do you think you're combining both studies or should we still expect the two separate releases? Thank you.
偉大的。感謝您提出問題。所以你們都只保留 M Radine 上的一個。在數據發布之前,我收到了許多投資者的問題。因此,也許您可以根據數據對您希望看到的情況設定期望水平,特別是顯然,現在我們已經獲得了布里斯托爾的批准,您對 FC 安全狀況的看法是什麼?對手以及他們提出的交付者測試要求?根據您的數據,這也是您所期望的嗎?然後,就數據發布而言,您希望發布什麼新聞稿,或者您認為您正在結合這兩項研究,還是我們仍然應該期待這兩個單獨的發布?謝謝。
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
You Iel it. I'll take that one. So a couple of things maybe, maybe starting with what we've observed with the approval. So we were encouraged by the lack of a boxed warning. Meaning there's a recognition that this is a unique mechanism of action looking specifically at the muscarinic class. So we were pleased to see that. I think what was notable for us was the G I adverse events including how that would play out in terms of longer term tolerability, also anticholinergic effects, bladder retention. That was something I guess we did not anticipate. You mentioned hepatic monitoring. That was something that we didn't anticipate. The other thing that was notable is along with the B ID dosing, there is a food effect. So you have to wait a certain period amount of time when you eat and after you eat, when you can take the pill.
你就知道了。我會接受那個。因此,可能有幾件事,也許從我們在批准中觀察到的情況開始。因此,我們對沒有黑框警告感到鼓舞。這意味著人們認識到這是一種專門針對毒蕈鹼類的獨特作用機制。所以我們很高興看到這一點。我認為對我們來說值得注意的是 G I 不良事件,包括長期耐受性、抗膽鹼能作用、膀胱保留方面的影響。我想這是我們沒有預料到的。您提到了肝臟監測。這是我們沒有預料到的。另一件值得注意的事情是,除了 B ID 劑量外,還有食物效應。所以吃飯時和飯後一定要等一段時間才能吃藥。
So when we think about our profile, we continue to be encouraged with the radine being a single agent. Well, once a day, no food effect, we don't see the extent of G I effects. We don't, we have not observed in the phase one B data, any bladder issues. And when we had looked at that one B data, we didn't see any hepatic issues. So we don't anticipate any type of laboratory monitoring. Also, we were also thinking about neurodegeneration associated psychosis and these patients are typically older and likely more sensitive to anticholinergic effects. So we continue to see an opportunity in that patient population as well. So we've stated that the data will read out here in the next couple of months in the quarter.
因此,當我們考慮我們的概況時,我們繼續對拉丁作為單一藥物感到鼓舞。嗯,每天一次,沒有食物影響,我們看不到 G I 影響的程度。我們沒有,我們在第一階段 B 數據中沒有觀察到任何膀胱問題。當我們查看該 B 數據時,我們沒有發現任何肝臟問題。因此,我們預計不會進行任何類型的實驗室監測。此外,我們也考慮了神經退化相關的精神病,這些患者通常年齡較大,可能對抗膽鹼能作用較敏感。因此,我們也繼續在患者群體中看到機會。因此,我們已經聲明,數據將在本季接下來的幾個月內在這裡讀出。
You know, the the same team is working on wrapping up these two studies. So depending on how far apart the data are, will probably determine as you stated. Is it one or two press releases? It's a little early right now for us to tell you, is it going to be one or two? But if they're going to be close together, it's potentially going to be one.
你知道,同一個團隊正在努力完成這兩項研究。因此,根據數據相距多遠,可能會如您所述確定。是一篇還是兩篇新聞稿?現在我們告訴你還太早,是一還是兩個?但如果他們要走得很近,那很可能會成為一個。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thank you VML operator. Next question, please.
謝謝VML操作員。請下一個問題。
Operator
Operator
Thank you. Our next question comes from Terence Flynn with Morgan Stanley. You may ask your question.
謝謝。我們的下一個問題來自摩根士丹利的特倫斯·弗林。你可以問你的問題。
Terence Flynn - Analyst
Terence Flynn - Analyst
Hi. Thanks for taking the question. Maybe a two part for me is just wondering if you can. I'm assuming contractings now wrapped up if you can comment at all on, on how to think about Skyrizi and Rinvoq formula positioning and pricing just high level for 2025. Thank you.
你好。感謝您提出問題。也許對我來說分兩部分只是想知道你是否可以。如果您能評論如何考慮 Skyrizi 和 Rinvoq 配方定位以及 2025 年的高水準定價,我假設合約現在已經完成。
Jeffrey Stewart - Executive Vice President, Chief Commercial Officer
Jeffrey Stewart - Executive Vice President, Chief Commercial Officer
Yeah. Hi, it's Jeff. So yeah, contracting is, is very, very close to wrapping up. We have, we have a few more nuances and so typically that may take another month or so. Overall, we're making very good progress on contracting next year. So in terms of, of what we've highlighted in the past is we, we do not anticipate any material change for Skyrizi and Rinvoq in terms of the access for next year across Medicare or the commercial plans we have, we have quite high, very broad access.
是的。嗨,我是傑夫。所以,是的,合約已經非常非常接近結束了。我們有,我們還有一些細微差別,因此通常可能還需要一個月左右的時間。總體而言,我們明年在合約方面取得了很好的進展。因此,我們過去強調的是,我們預計 Skyrizi 和 Rinvoq 在明年的醫療保險准入或我們擁有的商業計劃方面不會發生任何重大變化,我們有很高的期望,非常廣泛的訪問。
And we, we assume that that will continue in terms of what we've highlighted to anticipate, you know, we've, we've said that we, we do have over our near term and LRP sort of a negative pricing environment, but it's modest. It's nothing like we saw, you know, many quarters ago where we had seven indications. So we said from a rebate perspective, you know, low single digit changes is a reasonable assumption that we, that we feel confident. And despite we're not fully complete, I think that's a fair assessment at this point.
我們認為,就我們所強調的預期而言,這種情況將繼續下去,你知道,我們已經說過,我們在短期內和 LRP 確實面臨著一種負面的定價環境,但這是適度的。這與我們在許多季度前看到的那樣不同,當時我們有七個跡象。所以我們從回扣的角度來看,你知道,低個位數的變化是一個合理的假設,我們感到有信心。儘管我們尚未完全完成,但我認為目前這是一個公平的評估。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks Terence operator. Next question, please.
謝謝特倫斯接線生。請下一個問題。
Operator
Operator
Thank you. And this question comes from Chris Citan with Goldman Sachs. You may ask your question.
謝謝。這個問題來自高盛的 Chris Citan。你可以問你的問題。
Hey, Chris Sujai, your line is open. You may ask your question.
嘿,Chris Sujai,您的線路已接通。你可以問你的問題。
Chris Shibutani - Analyst
Chris Shibutani - Analyst
Apologies. I was on mute. Thank you for the question. All the comments you've made about Skyris, your invo and the molecule switching. Very helpful. Just curious as we think on the forward about other potential mechanisms and modalities in particular. I think we have competitor oral data that's coming up interested to hear your thoughts in terms of that modality difference as well as you know, how you might rank your optimism for some of the new mechanisms of action. I believe you have a tl one A as well in your pipeline. The earlier stage. Thank you.
抱歉。我當時處於靜音狀態。謝謝你的提問。你對 Skyris、你的 invo 和分子轉換所做的所有評論。非常有幫助。當我們思考其他潛在機制和模式時,我們只是感到好奇。我認為我們有競爭對手的口頭數據,他們有興趣聽聽您對這種模式差異的想法,以及您知道如何評價您對某些新行動機制的樂觀態度。我相信您的管道中也有一個 tl one A。早期階段。謝謝。
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Hi, Chris. It's RPA. I'll take that one with respect to the oral I'll, I'll take us back to the Skyrizi head to head that occurred with the premias, which is also an oral. The, the data were substantially higher from an efficacy standpoint for Skyrizi. As was the tolerability along with when we asked patients, what did they prefer? They actually preferred quarterly subcutaneous dosing.
嗨,克里斯。這是 RPA。我將帶我們回到與 premias 發生的 Skyrizi 頭對頭,這也是一場口頭賽。從功效的角度來看,Skyrizi 的數據要高得多。當我們詢問患者時,他們更喜歡什麼?他們實際上更喜歡每季皮下給藥。
So, I would think about it that way as well. Now, the question would be, it's a similar mechanism. Could the efficacy be better than what has been observed with a premias in psoriasis? Well, what we saw in the phase two data, my recollection still is that Skyrizi is a full 50% higher when it comes to full skin clearance at a pase 100. And that's where the bar is now at Patsy 90 Pasi 100.
所以,我也會這樣想。現在的問題是,這是一個類似的機制。其療效是否會比在乾癬中觀察到的效果更好?嗯,我們在第二階段的數據中看到的,我仍然記得 Skyrizi 在 Pase 100 的全皮膚清除率方面高出整整 50%。
So we still see an efficacy advantage. Also, the data I'm sharing are phase three Skyrizi data. The data that we saw for the oral 23 was from phase two. So there is a reasonable potential that the efficacy data tend to settle down when you go to a broader patient population, especially those that have had longer standing disease or have seen other therapies like other biologics. So we continue to feel very good and optimistic about our profile versus any emerging competition.
所以我們仍然看到功效優勢。另外,我分享的數據是 Skyrizi 第三階段的數據。我們看到的口頭 23 資料來自第二階段。因此,當你研究更廣泛的患者群體時,尤其是那些患有長期疾病或已經接受過其他療法(如其他生物製劑)的患者,療效數據有可能趨於穩定。因此,與任何新興競爭對手相比,我們仍然對自己的形象感到非常良好和樂觀。
Also, we we we think about our assets from a global standpoint and when you think about the majority of the countries, they are very driven by efficacy to gain access and in the oral space, we don't really see it across the globe. Maybe there's a couple of countries, I think Jeff has mentioned the US but that that space may be referred to as a prebiologic space. So maybe more of an influence on the on the T two or on a pre is, is how we see it in terms of other mechanisms that we like.
此外,我們從全球的角度來考慮我們的資產,當你想到大多數國家時,他們非常受到獲得訪問權的效率的驅動,而在口頭空間中,我們並沒有真正在全球範圍內看到它。也許有幾個國家,我想傑夫提到了美國,但那個空間可能被稱為前生物空間。因此,也許對 T 2 或 pre 的影響更大的是我們如何看待我們喜歡的其他機制。
As I mentioned, we like anti L 23 the way it's delivered with Skyrizi, the depth of response, the high durability and the convenience with quarterly dosing if we can couple that with other assets. As part of our combination approach, we think that's going to be extremely competitive in the future mechanisms like TL One A we think are going to be important, especially from a combination approach which we have one internally.
正如我所提到的,我們喜歡抗 L 23,因為它與 Skyrizi 一起提供的方式、響應深度、高耐用性以及季度給藥的便利性(如果我們可以將其與其他資產結合)。作為我們組合方法的一部分,我們認為這在我們認為很重要的 TL One A 等未來機制中將極具競爭力,特別是從我們內部擁有的組合方法來看。
We think the ulcerative colitis data are encouraging but from a monotherapy standpoint, not differentiated, especially when you look at the Skyrizi data that I mentioned earlier and RVO and then in chros, something like TL one A, we think it really does need a combo. So that will be part of our platform along with our novel alpha four beta seven. We think that's also a good combo. And then we've also provided very strong data in hydrid niis TIVA with our Il one alpha beta Lhi.
我們認為潰瘍性結腸炎的數據令人鼓舞,但從單一療法的角度來看,沒有差異化,特別是當你查看我之前提到的Skyrizi 數據和RVO 以及chros 中的數據(例如TL one A)時,我們認為它確實需要組合。因此,這將與我們的小說 alpha 4 beta 7 一起成為我們平台的一部分。我們認為這也是一個很好的組合。然後我們也透過我們的 Il one alpha beta Lhi 提供了非常強大的 Hydrid niis TIVA 數據。
And we've seen some preclinical signals that il 11 beta could be a driver of disease and resistance to other biologics. So Lhi will also be part of the combo in our IBD platform. So that's just some of the mechanisms that we're excited about. There's several others that are early in the pipeline and we will give you more information about those as the data mature.
我們已經看到一些臨床前訊號表明 il 11 beta 可能是疾病和對其他生物製劑產生抗藥性的驅動因素。因此,Lhi 也將成為我們 IBD 平台組合的一部分。這只是我們感到興奮的一些機制。還有其他幾個項目正處於早期開發階段,隨著數據的成熟,我們將向您提供有關這些項目的更多資訊。
Operator
Operator
Question, please.
請提問。
Thank you. Our next question comes from Tron Win with U Bs. You may ask your question.
謝謝。我們的下一個問題來自 Tron Win 和 U Bs。你可以問你的問題。
Trung Huynh - Analyst
Trung Huynh - Analyst
Hi guys. Thanks for taking my question. Just on the aesthetics business in the Q&A you did mention that you still have a tremendous amount of confidence hitting that longer term guide here. I'm curious on how dependent this is on the economic environment is getting better and getting better quickly. So you've moderated your Juvederm outlook this year because it's not being good. If next year is another challenging economic year, could we see that 9 billion in 2029 being moderated or even pulled? Just what's giving you confidence? Thank you.
嗨,大家好。感謝您提出我的問題。就美學業務而言,您在問答中確實提到,您仍然對此處的長期指南充滿信心。我很好奇這對經濟環境的改善和快速改善有多大的依賴。因此,您今年對 Juvederm 的前景進行了調整,因為情況不佳。如果明年又是一個充滿挑戰的經濟年,我們是否會看到2029年的90億會被放緩甚至拉低?是什麼給了你信心?謝謝。
Robert Michael - Chief Executive Officer
Robert Michael - Chief Executive Officer
So thanks for the question. This is Rob, I'll take that one. So, you know, as we think about the long term guy that is greater than 9 billion by 2029 you need to believe that you can have essentially a compound growth of around 11% to get there. If we look at the historical growth of this market, it's been, let's say call it low double digits, low 10s as we look at it going forward, we think probably a more prudent assumption is when we see the recovery something more in the high single digits, right?
謝謝你的提問。這是羅布,我選那個。所以,你知道,當我們考慮到 2029 年人口將超過 90 億的長期目標時,你需要相信基本上可以實現 11% 左右的複合成長率才能實現這一目標。如果我們看看這個市場的歷史成長,我們可以說它是低兩位數、低10 位數,當我們展望未來時,我們認為可能更謹慎的假設是,當我們看到復甦時,會出現更多的高位成長。
So, so you need something beyond just the market recovery to get there. And when we look at the innovation that we're bringing, particularly with the the short onset, short acting or fast onset short acting BTI that we expect to launch in 26 that could really transform the market. Because if you think about the number one barrier for, for patients is fear of an unnatural look that could really unlock a part of the market that's dormant right now. Plus it could also lead to share gains.
因此,要實現這一目標,您需要的不僅僅是市場復甦。當我們看到我們帶來的創新時,特別是我們預計在 26 年推出的短起效、短效或快速起效短效 BTI,它們可能真正改變市場。因為如果你考慮一下,對患者來說,最大的障礙是擔心不自然的外觀,這可能會真正釋放目前休眠的部分市場。此外,它還可能帶來股票收益。
And so I think we need to see one how the market recovers, I would say 25 and 26 and then ultimately see the, how the BTI launch ramps in 26. At that point, we'll have a better sense of, you know, the 9 billion as we sit here today, if you believe that the market will recover to high single digits, and we have a lot of confidence in BTI, we still believe we can get there, which is why we're not updating that guidance. But I would expect us to reflect more on that more likely in the 26 time frame than in 25.
因此,我認為我們需要看到市場如何復甦,我想說的是 25 和 26,然後最終看到 BTI 的推出如何在 26 中加速。我們坐在這裡的90 億美元,如果您相信市場將恢復到高個位數,並且我們對BTI 有很大信心,我們仍然相信我們可以實現這一目標,這就是為什麼我們不更新該指引。但我希望我們在 26 年的時間框架內比在 25 年的時間框架內更有可能對此進行更多反思。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks Trung Operator. Next question, please.
感謝特朗接線生。請下一個問題。
Operator
Operator
Thank you. And next question comes from Jeff Meacham with city. You may ask your question.
謝謝。下一個問題來自傑夫·米查姆(Jeff Meacham)和城市。你可以問你的問題。
Geoff Meacham - Analyst
Geoff Meacham - Analyst
Good morning, everyone. Thanks for the question. Had a bigger picture one for, for Rob. So when, when I look at your therapeutic areas, you know, ICA stands out as one that's pretty modest contributed today and, and also down the road, you know, how would you rank that, that business strategically and then related when you look at BD going forward, are there other tas that you're looking at that could be additive just thinking specifically maybe metabolic or, or cardio? Thank you.
大家早安。謝謝你的提問。羅布有一個更大的願景。因此,當我查看您的治療領域時,您知道,ICA 脫穎而出,因為它在今天做出了相當適度的貢獻,而且在未來,您知道,您會如何從戰略上對該業務進行排名,然後當您查看時相關聯在 BD 展望未來,您是否正在考慮其他可以附加的任務,只是具體考慮可能是代謝或有氧運動?謝謝。
Robert Michael - Chief Executive Officer
Robert Michael - Chief Executive Officer
Thanks for the question, Jeff. So this is Rob. So, so yeah, I mean, if you, our main focus is our five key growth areas, which includes eyecare includes immunology, oncology, neuroscience, aesthetics, and eye care. And we, you know, we participate in large markets with high unmet need that have great growth potential. And within those five verticals, you know, we're building depth across 24 core areas that does include eye care as as well. If you think about diabetic retinopathy, wet AMD, prescription, dry eye medications. And so eyecare does play an important role, but albeit it's not as high of a growth driver as the other four verticals, but it is part of our five and that ultimately guides both our internal R&D investments as well as our BD efforts which as you know, continue to be very active.
謝謝你的提問,傑夫。這就是羅布。所以,是的,我的意思是,如果您的話,我們的主要關注點是我們的五個關鍵增長領域,其中包括眼保健,包括免疫學、腫瘤學、神經科學、美學和眼保健。你知道,我們參與的大型市場存在大量未滿足的需求,並且具有巨大的成長潛力。您知道,在這五個垂直領域中,我們正在 24 個核心領域建立深度,其中也包括眼部護理。如果您考慮糖尿病視網膜病變、濕性 AMD、處方藥、乾眼藥。因此,眼保健確實發揮著重要作用,但儘管它的成長動力不如其他四個垂直行業,但它是我們五個垂直行業的一部分,最終指導我們的內部研發投資以及我們的業務拓展工作,知道,繼續非常活躍。
You know, so far this year, we've executed 15 deals along those lines, really focus more on, you know, early stage opportunities to drive growth in the next decade. So that's our primary focus. Now, if we see an opportunity for differentiation in a large market with high need like metabolics, we would consider pursuing it, especially if we can help drive growth in the next decade. But again, it would be more opportunistic. We'd have to see differentiation and, and right now, it's not our primary focus. But again, you know, we're open to more sources of growth for the next decade. If we see differentiation that we can create value and we certainly have the financial wherewithal to pursue those opportunities.
你知道,今年到目前為止,我們已經執行了 15 筆此類交易,真正更專注於推動未來十年成長的早期機會。這是我們的首要關注點。現在,如果我們在新陳代謝等高需求的大市場中看到差異化的機會,我們會考慮追求它,特別是如果我們能夠幫助推動未來十年的成長。但同樣,這將更加機會主義。我們必須看到差異化,而現在這不是我們的主要關注點。但同樣,你知道,我們對未來十年的更多成長來源持開放態度。如果我們看到差異化,我們就可以創造價值,而我們當然有財力去追求這些機會。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks, Jeff Operator. Next question, please.
謝謝,傑夫接線員。請下一個問題。
Operator
Operator
Thank you. Our next question comes from James Shin with Deutsche Bank. Let me ask you a question.
謝謝。我們的下一個問題來自德意志銀行的 James Shin。讓我問你一個問題。
James Shin - Analyst
James Shin - Analyst
Good morning guys. Thanks for taking our question for INRS read out. I think there's a question on how much erosion could be anticipated. And I know you mentioned that the team, same team that was originally working on the phase one B wrapping up studies and so forth. But, you know, there's been some other data that has copied some of cerebral strategies such as high baseline pans and so forth and placebo effect was still kind of surprisingly higher than it should be. Is there any insight on managing this placebo effect? Thank you.
早安,夥計們。感謝您提出我們的問題,以便 INRS 讀出。我認為存在一個問題,即可以預見到多少侵蝕。我知道你提到過這個團隊,最初從事 B 階段研究等工作的團隊。但是,你知道,還有一些其他數據複製了一些大腦策略,例如高基線平底鍋等等,而安慰劑效應仍然令人驚訝地高於應有的水平。對於管理這種安慰劑效應有什麼見解嗎?謝謝。
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Thanks, James. It's ruple. You know, when we did our, our, our thorough diligence, that was a major question that we and the broader team had. So you, you bring up a good point. Some things that we we observed in those two studies that will be the pivotal readouts were what SVAL was strategically doing. One thing was limiting the number of countries limiting the number of sites. Central review for eligibility criteria, training of Raiders, certifying those Raiders recertifying Raiders monitoring blinded data with respect to site activity.
謝謝,詹姆斯。是盧布。你知道,當我們進行徹底的盡職調查時,這是我們和更廣泛的團隊面臨的一個主要問題。所以你提出了一個很好的觀點。我們在這兩項研究中觀察到的一些事情將成為關鍵讀數,而這正是 SVAL 策略上所做的事情。一件事是限制國家數量,限制網站數量。對資格標準進行集中審查,對襲擊者進行培訓,對襲擊者進行認證,對襲擊者進行重新認證,監視有關站點活動的盲數據。
So I think those are, those are important factors that could drive placebo in either direction. So what we observed was I we would say a good control or at least the, the best one could do to manage, manage placebo responses. So, you know, it, it's hard to know what if there's any erosion until we see the data. But the effect size that we did see in the phase one B was a little over 12 points. So we think that was a strong separation and even if that were to go down a little bit, we still feel that based on the, the safety profile and tolerability profile, this could still be very, very competitive even if we saw a droppage in, in some point on the efficacy side.
所以我認為這些都是可能推動安慰劑朝任一方向發展的重要因素。所以我們觀察到的是,我們會說這是一個很好的對照,或至少是最好的對照,可以管理安慰劑反應。所以,你知道,在我們看到資料之前,很難知道是否有侵蝕。但我們在第一階段 B 中看到的效應大小略高於 12 點。因此,我們認為這是一個很強的分離,即使下降了一點,我們仍然認為,基於安全性和耐受性,即使我們看到了下降,這仍然可能非常非常有競爭力。功效方面。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks James operator. Next question, please.
感謝詹姆斯接線生。請下一個問題。
Operator
Operator
Thank you. Our next question comes from Carter Gold with Barclays. Your line is open. You may ask your question.
謝謝。我們的下一個問題來自巴克萊銀行的卡特‧戈爾德。您的線路已開通。你可以問你的問題。
Carter Gould - Analyst
Carter Gould - Analyst
Great, good morning. Thanks for taking the questions. I was hoping to you know, follow up a little bit on the the ATA acquisition sort of, you know, what differentiation you saw over some of the other enhanced brain deliver kind of approach is there to give you confidence. And maybe, you know, we've seen a take a number of shots on goal across Alzheimer's here, just seems pretty central to your longer term neuroscience portfolio. Can you maybe just again, put put that in some, some broader context as you think about the T A strategy longer term? Thank you.
太好了,早安。感謝您提出問題。我希望你知道,對 ATA 收購進行一些跟進,你知道,你看到的與其他一些增強型大腦交付類型方法相比的差異可以給你信心。也許,你知道,我們已經看到了阿茲海默症患者的多次射門,這似乎對你的長期神經科學投資組合非常重要。當您考慮長期 T A 策略時,您能否再次將其放在更廣泛的背景下?謝謝。
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Sure. It's RPO. I, I'll take that. Yes, we've been investing for a number of years in the space and in addition to the, to the recent deal, we'll, we'll have an option read out with Elector and Trem two. Coming up, we have a SV two A molecule that would look at cognition and other symptoms. Mirali could participate in that space from an Alzheimer's psychosis standpoint.
當然。這是恢復點目標。我,我會接受的。是的,我們已經在這個領域投資了很多年,除了最近的交易之外,我們還將與 Elector 和 Trem 兩個一起讀出選擇權。接下來,我們有一個 SV 兩個 A 分子,可以觀察認知和其他症狀。從阿茲海默症精神病的角度來看,米拉利可以參與這個領域。
We have other pipeline assets that are looking at at Tau intracellular and even an approach looking at extracellular tau, we did have our own a beta monotherapeutic antibody, which we did read out, it did look good, but it wasn't fully differentiated and moving on to the alta deal. What, what we see there is the ability to access the CS F at what we would say at this stage at higher concentrations than maybe other competitors. So we think that's a good thing.
我們還有其他正在研究細胞內Tau 的管道資產,甚至還有一種研究細胞外tau 的方法,我們確實有自己的β 單藥治療抗體,我們確實讀出了它,它看起來確實不錯,但它沒有完全分化,繼續討論阿爾塔交易。我們看到的是,我們現階段能夠以比其他競爭對手更高的濃度進入 CS F。所以我們認為這是一件好事。
The other aspect that we like is a extended half life so that could lead to a convenient dosing. And if this approach plays out then one could consider having subcutaneous dosing, even even getting out to monthly. And if the efficacy is, is high because of deeper brain penetration, that could result in lower levels faster and a better able to see cognition benefits in a year or 18 months. So those are some of the benefits that we would see the the other benefit would be getting to the pereny tissue more broadly.
我們喜歡的另一個方面是延長半衰期,這樣可以方便給藥。如果這種方法有效,那麼人們可以考慮皮下給藥,甚至每月一次。如果由於大腦滲透更深而功效很高,那麼可能會更快地降低水平,並且能夠在一年或 18 個月內更好地看到認知益處。這些是我們會看到的一些好處,另一個好處是更廣泛地惠及多年生組織。
And that could have a reduction in Aria, which is, is probably what is disallowing this to really take off. It's very challenging to take an elderly family member to get multiple scans and worry about them having stroke like symptoms. So that would be something else we believe we can address with this asset of having a strong safety profile, tolerability, ease of onboarding and high efficacy and ultimately strong benefits on cognition.
這可能會導致 Aria 的減少,這可能是阻礙它真正起飛的原因。帶老年家庭成員進行多次掃描並擔心他們出現中風樣症狀是非常具有挑戰性的。因此,我們相信我們可以利用這項資產來解決這個問題,即具有強大的安全性、耐受性、易於上手和高功效,並最終對認知產生巨大的好處。
Robert Michael - Chief Executive Officer
Robert Michael - Chief Executive Officer
And this is Rob, I'll just add on here as we think about strategically about the Neuroscience franchise. I mean, I think about it as having really four main segments, you have psychiatry, migraine Parkinson's then neurodegeneration. And if you look at what we've done to build out the long term growth outlook for this franchise, obviously, in Psychiatry between Creval Gideon Richter, we also had the early stage opportunity with Gilgamesh, you know, really investing in longer term growth in psychiatry.
這是羅布,當我們從戰略上思考神經科學特許經營權時,我將在這裡補充一下。我的意思是,我認為它實際上有四個主要部分,包括精神病學、偏頭痛、帕金森病,然後是神經退化性疾病。如果你看看我們為這個系列的長期成長前景所做的工作,顯然,在Creval Gideon Richter 之間的精神病學領域,我們也與吉爾伽美甚一起獲得了早期階段的機會,你知道,真正投資於長期增長在精神醫學。
We have actually a very strong franchise in Migraine with the Oral cgrps as well as Botox Therapeutic and Parkinson's now with the launch of Vial, which is performing very nicely outside the US. And we expect we will also perform nicely in the US, the early phase three data we've seen so far for Divad on the mito and disease modifying approach. It's early and Parkinson's another investment we've made.
實際上,我們在偏頭痛方面擁有非常強大的專營權,包括口服 cgrps 以及肉毒桿菌治療和帕金森氏症治療,現在推出了 Vial,該藥物在美國以外的地區表現非常出色。我們預計我們在美國也將表現出色,這是我們迄今為止看到的 Divad 關於粒線體和疾病修飾方法的早期三期數據。現在還為時過早,帕金森氏症是我們所做的另一項投資。
And then in Alzheimer's now with Alla is another, you know, another I say long term investment we're making to grow the Neuroscience franchise. There's also adjacencies like a S MS that we're interested in that we have some partnerships that we continue to pursue. And so we see neuroscience is an important long term growth driver for the company. We're obviously investing heavily across a number of areas, but we think about it really in those four categories. And so it's one that we're obviously very excited about the future prospects for.
現在與 Alla 一起治療阿茲海默症是另一項,你知道,我說的是我們為發展神經科學特許經營權而進行的另一項長期投資。我們也對諸如 S MS 之類的鄰接關係感興趣,我們將繼續尋求一些合作夥伴關係。因此,我們認為神經科學是該公司重要的長期成長動力。顯然,我們在多個領域進行了大量投資,但我們實際上是在這四個領域進行思考。因此,我們顯然對未來前景感到非常興奮。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks Carter operator. Next question, please.
感謝卡特接線生。請下一個問題。
Operator
Operator
Thank you. And this question comes from Steve Scala with Cowen. May I ask your question?
謝謝。這個問題來自 Steve Scala 和 Cowen。我可以問你的問題嗎?
Steve Scala - Analyst
Steve Scala - Analyst
Thank you so much. I'm a bit surprised at how Sabel was such a focus in the prepared remarks given the pending Irakly data, which very much will color views of the cerebral acquisition. Should we conclude you have increased confidence in or insight into the pending data and related to that KOL seem to be looking for an effect size of 0.6 but based on what was just said, that doesn't even seem to be a possibility. So, and any thoughts would be appreciated.
太感謝了。考慮到即將公佈的伊拉克數據,薩貝爾在準備好的評論中如此關注,我有點驚訝,這在很大程度上會為大腦採集的觀點帶來色彩。如果我們得出結論,您對待定資料的信心或洞察力增強,而與 KOL 相關的資料似乎正在尋找 0.6 的效應大小,但根據剛才所說的,這似乎根本不可能。因此,任何想法將不勝感激。
Robert Michael - Chief Executive Officer
Robert Michael - Chief Executive Officer
Thank you. This is Rob and RPA can take the second part. I'll take the first part of the question. So Steve, you know, in the prepared remarks, we're talking about the quarter, we obviously closed the cerebral transaction in the quarter. That's a significant event. We also did see the phase three trial results for TVA on. So that was important to comment as well as we've mentioned, we expect the two pivotals from RLI to read out in the fourth quarter. So I wouldn't read too much into it other than it was an important event to highlight in the quarter.
謝謝。這是 Rob 和 RPA 可以參加的第二部分。我將回答問題的第一部分。所以史蒂夫,你知道,在準備好的演講中,我們談論的是本季度,我們顯然在本季度結束了大腦交易。這是一個重大事件。我們也確實看到了 TVA 的第三階段試驗結果。因此,評論和我們提到的一樣重要,我們預計 RLI 的兩個關鍵數據將在第四季度公佈。因此,除了這是本季度需要強調的重要事件之外,我不會對其進行過多解讀。
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 ruple, I agree. We have two positive phase three studies with Tavapadon and in the oral space, I don't know if we've seen a new mechanism that could have this type of approach in, in, in a very long time. So it is important to discuss that because the unmet need continues to be very, very high. And Parkinson's is a place where we believe we can meaningfully participate in.
是的。我同意,它是盧布。我們對 Tavapadon 和口腔空間進行了兩項積極的第三階段研究,我不知道我們是否已經看到了一種新的機制,可以在很長一段時間內採用這種類型的方法。因此,討論這一點很重要,因為未滿足的需求仍然非常非常高。我們相信我們可以有意義地參與帕金森氏症的治療。
And the, and the effect size question, I I, you know, when we look at the one B data, it was more than a 12 point differential. So we have observed sometimes the detriment and the question was around if placebo responses move up a little bit. So that being said, we still think we can maintain a very strong effect size coupled with the safety profile. Remember that the issue here in in therapy isn't just about efficacy. It's about maintaining these patients on a drug that they can tolerate.
以及效應大小問題,我,你知道,當我們查看 1 個 B 數據時,差異超過 12 個百分點。因此,我們有時會觀察到這種損害,問題是安慰劑反應是否會上升一點。話雖這麼說,我們仍然認為我們可以保持非常強的效應大小和安全性。請記住,治療中的問題不僅僅是療效。這是為了讓這些患者繼續服用他們可以耐受的藥物。
And the majority of these patients don't last very long and cycle through these assets and even stop these especially atypicals without even letting their physicians know and then go on to have a flare and end up in the hospital. So we think about this as a, as a benefit risk and tolerability profile and from a weight, metabolic motor symptoms, sedation. These are major problems with atypicals and with something like a mirali, we feel that we can still fully differentiate. So I I don't know if I'd read into any concerns other than maybe seeing an effect that's slightly different than what we saw in phase one B. But beyond that, we think this could still be very competitive.
這些患者中的大多數都不會持續很長時間,並且會循環使用這些資產,甚至在沒有讓醫生知道的情況下停止這些特別非典型的治療,然後繼續發作並最終住院。因此,我們將其視為一種獲益風險和耐受性概況以及體重、代謝運動症狀和鎮靜作用。這些是非典型的主要問題,對於像 mirali 這樣的東西,我們認為我們仍然可以完全區分。所以我不知道除了可能看到的效果與我們在第一階段 B 中看到的略有不同之外,我是否會理解任何擔憂。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Thanks, Steve. Do we have time for one final question?
謝謝,史蒂夫。我們有時間問最後一個問題嗎?
Operator
Operator
Thank you. Our final question comes from Louisa Hector with Berenberg. You may ask your question.
謝謝。我們的最後一個問題來自路易莎·赫克托和貝倫貝格。你可以問你的問題。
Luisa Hector - Analyst
Luisa Hector - Analyst
Hello. Thanks for taking my question just on railer. Could you expand a little on, on the comments of the channel mix pressure in Q3 and how that will play out just as we move forward and perhaps just a quick comment on the extension of the collaboration with Gideon Rita and why you went down that route? Thank you.
你好。感謝您在railer 上提出我的問題。您能否詳細談談對第三季度頻道組合壓力的評論,以及我們前進時這種壓力將如何發揮作用,也許只是簡單評論一下與 Gideon Rita 合作的擴展以及您為什麼走這條路?謝謝。
Scott Reents - Chief Financial Officer, Executive Vice President
Scott Reents - Chief Financial Officer, Executive Vice President
I'll take the question regarding bra. So it was essentially it was a channel mix change. It was slight, I would tell you that really kind of had accumulated over the course of the year. And that's why we made, we decided it made sense to make the adjustment. So as that channel makes change, we saw a little bit of negative price as a result of that. So we took down the rail guidance by $100 million. Now, I would note in neuroscience in totality that was offset by the rays and Botox therapeutic. So, neuroscience and in our therapeutic or growth area guide is stable. So maybe the second question will go to Rupal.
我來回答關於胸罩的問題。所以本質上這是渠道組合的改變。我告訴你,這只是輕微的,確實是一年來累積的。這就是我們決定進行調整的原因。因此,當該通路發生變化時,我們看到了一些負價格。因此,我們將鐵路指導方針下調了 1 億美元。現在,我要指出的是,在神經科學中,射線和肉毒桿菌療法抵消了這一點。因此,神經科學和我們的治療或成長領域指南是穩定的。所以也許第二個問題會問魯帕爾。
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Roopal Thakkar - Executive Vice President, Research & Development and Chief Scientific Officer
Yeah, we it's Rupal. We, we, we expanded further. We, we've had a strong partnership. They're a terrific organization. We have a follow on to that's more D three leaning that will start entering the clinic quite soon in phase two, looking at bipolar depression and MD D as well as generalized anxiety disorder. As Rob described as part of our Neuroscience strategy Psychiatry is a big part of that. And having a deeper relationship with Gideon Richter will allow us to have potentially even more assets in depression in bipolar disorder in schizophrenia and anxiety and potentially other adjacent indications that we continue to be interested in because the unmet need continues to be very high.
是的,我們是魯帕爾。我們,我們,我們進一步擴大。我們,我們已經建立了牢固的合作關係。他們是一個很棒的組織。我們有一個後續的“更多 D 三傾向”,將很快在第二階段開始進入臨床,研究雙相抑鬱症、MD D 以及廣泛性焦慮症。正如羅布所描述的,作為我們神經科學策略的一部分,精神病學是其中的重要組成部分。與吉迪恩·里克特(Gideon Richter)建立更深入的關係將使我們在抑鬱症、雙相情感障礙、精神分裂症和焦慮症以及我們繼續感興趣的其他潛在適應症方面擁有更多的資產,因為未滿足的需求仍然非常高。
Liz Shea - Senior Vice President, Investor Relations
Liz Shea - Senior Vice President, Investor Relations
Well, thank you. And thanks Shirley, that concludes our conference conference call today. If you'd like to listen to a replay of the call, please visit our website at investors dot Abby dotcom. Thanks again. For joining us.
嗯,謝謝。感謝雪莉,我們今天的電話會議到此結束。如果您想收聽電話會議的重播,請造訪我們的網站:investors dot Abby dotcom。再次感謝。加入我們。
Operator
Operator
Thank you. And this concludes today's call, we thank you for your participation. And at this time you may disconnect your lines.
謝謝。今天的電話會議到此結束,我們感謝您的參與。此時您可以斷開線路。