艾伯維 (ABBV) 2023 Q2 法說會逐字稿

Good morning, and thanks for joining us. Also on the call with me today are Rick Gonzalez, Chairman of the Board and Chief Executive Officer; Rob Michael, President and Chief Operating Officer; Jeff Stewart, Executive Vice President and Chief Commercial Officer; Scott Reents, Executive Vice President and Chief Financial Officer; Carrie Strom, Senior Vice President, AbbVie and President, Global Allergan Aesthetics; and Tom Hudson, Senior Vice President, R&D and Chief Scientific Officer. Joining us for the Q&A portion of the call is Roopal Thakkar, Senior Vice President, Development and Regulatory Affairs and Chief Medical Officer.

早上好，感謝您加入我們。今天與我通話的還有董事會主席兼首席執行官 Rick Gonzalez；羅布·邁克爾，總裁兼首席運營官； Jeff Stewart，執行副總裁兼首席商務官； Scott Reents，執行副總裁兼首席財務官； Carrie Strom，艾伯維高級副總裁兼全球艾爾建美學總裁；以及研發高級副總裁兼首席科學官 Tom Hudson。開發和監管事務高級副總裁兼首席醫療官 Roopal Thakkar 參加了電話會議的問答部分。

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.

在我們開始之前，我要指出的是，根據我們當前的預期，我們今天發表的一些聲明可能被視為前瞻性聲明。艾伯維警告說，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.

有關這些風險和不確定性的更多信息包含在我們向 SEC 提交的文件中。艾伯維不承擔更新這些前瞻性陳述的義務，除非法律要求。在今天的電話會議上，將使用非公認會計準則財務指標來幫助投資者了解艾伯維的業務表現。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公認會計原則財務指標進行了協調一致，這些資料可以在我們的網站上找到。在我們準備好的發言之後，我們將回答您的問題。

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

因此，我會將電話轉給 Rick。

Thank you, Liz. Good morning, everyone, and thank you for joining us today. 2023 is an important year for AbbVie as we experience Humira biosimilar competition in the U.S. market, and as we execute our long-term diversification growth strategy. Now roughly 7 months into the year, I'm extremely pleased with the progress that we're making against these objectives.

謝謝你，莉茲。大家早上好，感謝您今天加入我們。 2023 年對於艾伯維來說是重要的一年，因為我們在美國市場經歷了 Humira 生物仿製藥的競爭，並且我們執行了長期多元化增長戰略。今年已經過去大約 7 個月了，我對我們在實現這些目標方面取得的進展感到非常滿意。

The U.S. Humira biosimilar impact is playing out as projected and slightly better than our planning assumptions. We are competing very effectively with the various biosimilar offerings. We have exceeded our guidance in burst in second quarters with the overachievement predominantly driven by our growth platform, the base portfolio, excluding Humira which, as you know, is the critical driver in our rapid return to growth in 2025 and beyond. To that point, this platform demonstrated operational revenue growth of nearly 8% this quarter with growth expected to further accelerate in the second half of this year. We are also once again raising our full year revenue guidance by $1 billion, which is on top of the $400 million sales increase we delivered in the first quarter for a total overachievement of $1.4 billion. And lastly, we are making good progress with our pipeline, across all stages of development, including recent strong data for Skyrizi in ulcerative colitis as well as the recent U.S. approvals for Rinvoq in Crohn's disease and Epkinly in relapsed or refractory DLBCL, both important new therapies for patients.

美國 Humira 生物仿製藥的影響正在按預期發揮，並且略好於我們的計劃假設。我們正在與各種生物仿製藥產品進行非常有效的競爭。我們在第二季度突然超出了我們的指導，超額業績主要是由我們的增長平台、基本投資組合（不包括修美樂）推動的，如您所知，修美樂是我們在 2025 年及以後快速恢復增長的關鍵驅動力。截至目前，該平臺本季度運營收入增長近 8%，預計今年下半年增長將進一步加速。我們還再次將全年收入指導提高了 10 億美元，這是在第一季度銷售額增加 4 億美元的基礎上，總超額業績達到 14 億美元。最後，我們的產品線在各個開發階段都取得了良好進展，包括最近 Skyrizi 在潰瘍性結腸炎方面的強勁數據，以及最近美國批准 Rinvoq 用於克羅恩病和 Epkinly 用於復發或難治性 DLBCL，這都是重要的新藥物為患者提供治療。

So in summary, I'm extremely pleased with the strong momentum and execution across the business. It reinforces our confidence in our ability to return to robust growth in 2025 with high single-digit compounded growth rate to the end of the decade.

總而言之，我對整個業務的強勁勢頭和執行力感到非常滿意。這增強了我們對 2025 年恢復強勁增長的信心，並在本十年末保持高個位數複合增長率。

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

這樣，我會將電話轉給 Rob，以獲取有關我們業務績效的更多評論。搶？

Thank you, Rick. AbbVie delivered excellent results once again this quarter. We are demonstrating strong execution across our business with each of our 5 key therapeutic areas beating expectations. We reported adjusted earnings per share of $2.91, which is $0.11 above our guidance midpoint.

謝謝你，瑞克。艾伯維本季度再次取得了優異的業績。我們在整個業務中展示了強大的執行力，我們的 5 個關鍵治療領域均超出了預期。我們公佈的調整後每股收益為 2.91 美元，比我們的指導中值高出 0.11 美元。

Total net revenues were nearly $13.9 billion, more than $350 million ahead of our guidance with the vast majority of the beat coming from our ex Humira growth platform. In immunology, Skyrizi and Rinvoq are demonstrating impressive growth with sales for both therapies up more than 50% versus the prior year. These 2 agents have achieved differentiated clinical profiles, including head-to-head data versus Humira and other novel therapies. Skyrizi and Rinvoq are now collectively approved across 10 large indications, and we are forecasting combined revenue growth of more than $3.5 billion this year with ongoing programs in several additional disease areas, we expect both Skyrizi and Rinvoq to deliver robust growth into the next decade and significantly exceed Humira peak revenue.

總淨收入接近 139 億美元，比我們的指引高出 3.5 億美元以上，其中絕大多數增長來自我們的前 Humira 增長平台。在免疫學領域，Skyrizi 和 Rinvoq 的增長令人印象深刻，兩種療法的銷售額比上一年增長了 50% 以上。這兩種藥物已經實現了差異化的臨床特徵，包括與 Humira 和其他新療法相比的頭對頭數據。 Skyrizi 和 Rinvoq 目前已在 10 個主要適應症中集體獲得批准，我們預計今年的綜合收入增長將超過 35 億美元，加上在其他幾個疾病領域正在進行的項目，我們預計 Skyrizi 和 Rinvoq 都將在未來十年實現強勁增長，顯著超過 Humira 峰值收入。

U.S. Humira is also performing well. The first half erosion coming in better than our expectations due to volume. We have been carefully analyzing the biosimilar marketplace, where the total number of competitors has now expanded to 8. While many of these biosimilars have been added to payer formularies, Humira continues to maintain strong parity access. Based on the volume trends and parity access, we now anticipate U.S. Humira erosion of approximately 35%, an improvement of 2 points versus our original guidance.

美國修美樂（Humira）也表現良好。由於成交量的原因，上半年的侵蝕情況好於我們的預期。我們一直在仔細分析生物仿製藥市場，該市場的競爭對手總數現已擴大到 8 個。雖然其中許多生物仿製藥已添加到付款人處方集中，但 Humira 繼續保持強大的平價准入。根據銷量趨勢和平價准入，我們現在預計美國 Humira 的侵蝕約為 35%，比我們最初的指導提高了 2 個百分點。

Neuroscience is another area that is outperforming expectations. Based on the current run rate, this portfolio is now on pace to add more than $1 billion of incremental revenue this year. with continued strong growth from Vraylar as well as our leading migraine portfolio. In aesthetics, the outlook continues to improve. We delivered positive growth this quarter, driven by strong international performance and stabilizing trends in the U.S. These positive trends give us the confidence to once again raise our full year guidance for aesthetics. And as a clear market leader, we are focused on expanding the aesthetics category with increased commercial investment and continued innovation to support robust long-term growth.

神經科學是另一個表現超出預期的領域。根據目前的運行速度，該投資組合今年有望增加超過 10 億美元的增量收入。隨著 Vraylar 以及我們領先的偏頭痛產品組合的持續強勁增長。在美學方面，前景不斷改善。在強勁的國際業績和美國穩定趨勢的推動下，我們本季度實現了正增長。這些積極趨勢使我們有信心再次提高全年美學指導。作為明顯的市場領導者，我們致力於通過增加商業投資和持續創新來擴大美學類別，以支持強勁的長期增長。

Given the strong and balanced performance across our diverse portfolio, we are raising our full year adjusted earnings per share guidance by $0.23 and now expect adjusted earnings per share between $10.90 and $11.10. In closing, our operational execution has been outstanding, and we are very well positioned to deliver on our commitments in 2023 and beyond.

鑑於我們多元化投資組合的強勁和平衡表現，我們將全年調整後每股收益指導上調 0.23 美元，目前預計調整後每股收益在 10.90 美元至 11.10 美元之間。最後，我們的運營執行非常出色，我們完全有能力在 2023 年及以後兌現我們的承諾。

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

這樣，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？

Thank you, Rob. I'll start with immunology, which delivered total revenues of $6.8 billion, exceeding our expectations. Skyrizi continues to perform exceptionally well. Global sales were approximately $1.9 billion, reflecting very strong operational growth of 51%. Our performance in psoriasis continues to be impressive. Total prescription share in the U.S. biologic market is now at 32%, double the share of the next closest biologic therapy.

謝謝你，羅布。我將從免疫學開始，該領域的總收入達到 68 億美元，超出了我們的預期。 Skyrizi 繼續表現出色。全球銷售額約為 19 億美元，反映出 51% 的強勁運營增長。我們在牛皮癬方面的表現仍然令人印象深刻。美國生物製劑市場的總處方份額目前為 32%，是排名第二的生物療法份額的兩倍。

When you consider that Skyrizi is capturing roughly 1 out of 2 every in-play patients, which are either new to therapy or switching, there remains substantial opportunity for continued robust sales growth. And based on the available clinical data we are seeing from emerging competitive therapies in psoriasis, including orals. We feel very confident in Skyrizi's long-term potential with robust sales growth expected through the early part of the next decade. We are also seeing very nice prescription growth in psoriatic arthritis, especially in the U.S. dermatology segment where Skyrizi is approaching the leading new patient biologic market share. Skyrizi's momentum across psoriatic disease is very solid globally as well. with total in-play share leadership in nearly 30 key countries.

當您考慮到 Skyrizi 捕獲了大約二分之一的參與治療患者（這些患者要么是剛開始接受治療，要么是轉換治療）時，仍然存在持續強勁銷售增長的巨大機會。根據現有的臨床數據，我們從新興的銀屑病競爭療法（包括口服療法）中看到。我們對 Skyrizi 的長期潛力充滿信心，預計在下一個十年初期銷售將強勁增長。我們還看到銀屑病關節炎的處方增長非常好，特別是在美國皮膚科領域，Skyrizi 正在接近領先的新患者生物製劑市場份額。 Skyrizi 在全球範圍內治療銀屑病的勢頭也非常強勁。在近 30 個主要國家/地區的實際份額中處於領先地位。

Turning now to IBD, where Skyrizi has demonstrated a very compelling clinical profile, including strong endoscopic data paired with convenient dosing. Uptake in Crohn's disease has been rapid, with total in-play patient share of approximately 25% in the U.S., roughly at parity leadership with Stelara. This uptake is very encouraging for Skyrizi's potential in ulcerative colitis, where we recently reported positive maintenance data with approval and commercialization anticipated next year.

現在轉向 IBD，Skyrizi 展示了非常引人注目的臨床特徵，包括強大的內窺鏡數據和方便的劑量。克羅恩病的治療速度很快，在美國，在場患者的比例約為 25%，與 Stelara 大致持平。這種吸收對於 Skyrizi 在潰瘍性結腸炎方面的潛力非常令人鼓舞，我們最近報告了積極的維持數據，預計明年獲得批准和商業化。

Given the momentum we are seeing across all of the approved indications, we will be raising our full year sales outlook for Skyrizi.

鑑於我們在所有批准的適應症中看到的勢頭，我們將提高 Skyrizi 的全年銷售預期。

Moving now to Rinvoq which delivered global sales of $918 million, reflecting operational growth of nearly 57%. A key element of Rinvoq's success is its strong differentiation. It is now approved across 7 distinct indications, including 4 in rheumatology, 2 in IBD as well as atopic dermatitis. It's the only potent daily oral medication with compelling head-to-head data against multiple novel therapies, including superiority to Humira in RA and Dupixent in AD. It's the only JAK inhibitor now approved to treat both Crohn's disease and ulcerative colitis. And we have established strong and broad commercial access for each of the core diseases with formulary coverage for Crohn's expected to ramp quickly over the next months. As it pertains to Rinvoq's performance, we are seeing increasing prescriptions across each of the room indications globally, further market share momentum in atopic dermatitis, including now high-teens in-play patient share in the U.S. and robust uptake in IBD, where Rinvoq has demonstrated strong rates of remission and endoscopic improvement. Rinvoq is now capturing roughly 1 out of every 4 in-play ulcerative colitis patients in the second line plus setting.

現在來看 Rinvoq，其全球銷售額達到 9.18 億美元，運營增長近 57%。 Rinvoq 成功的一個關鍵因素是其強大的差異化優勢。目前該藥物已獲批用於 7 種不同的適應症，其中 4 種用於風濕病、2 種用於 IBD 以及特應性皮炎。它是唯一一種有效的每日口服藥物，具有針對多種新型療法的令人信服的頭對頭數據，包括在治療 RA 方面優於 Humira 和在 AD 方面優於 Dupixent。它是目前唯一被批准用於治療克羅恩病和潰瘍性結腸炎的 JAK 抑製劑。我們已經為每種核心疾病建立了強大而廣泛的商業准入，克羅恩病的處方覆蓋範圍預計將在未來幾個月內迅速增加。就 Rinvoq 的業績而言，我們看到全球每種房間適應症的處方量都在增加，特應性皮炎的市場份額進一步增長，包括目前在美國的高青少年患者份額，以及 Rinvoq 在 IBD 領域的強勁增長顯示出很高的緩解率和內鏡改善率。 Rinvoq 現在在二線及以上環境中捕獲了大約四分之一的比賽中潰瘍性結腸炎患者。

And the early data for Crohn's, which launched just in May, also shows a very strong ramp in new patient starts. We remained well positioned for continued momentum in this new indication as the only JAK inhibitor approved to treat Crohn's disease. This level of performance, along with the development of ongoing projects across several other diseases, such as giant cell arteritis and systemic lupus in rheumatology and multiple additional derm indications, reinforces the long-term potential for Rinvoq with strong sales growth expected through the early part of the next decade.

五月份剛剛推出的克羅恩病的早期數據也顯示出新患者數量的強勁增長。作為唯一被批准用於治療克羅恩病的 JAK 抑製劑，我們在這一新適應症中保持著良好的持續發展勢頭。這種水平的業績，加上針對其他幾種疾病（例如風濕病中的鉅細胞動脈炎和系統性狼瘡以及多種其他皮膚適應症）正在進行的項目的開發，增強了 Rinvoq 的長期潛力，預計早期銷售將強勁增長下一個十年。

Global Humira sales were $4 billion, down 24.8% on an operational basis due to biosimilar competition. erosion in the U.S. remains slightly better than our expectations due to volume with the vast majority of the impact this quarter driven by price.

由於生物仿製藥競爭，修美樂全球銷售額為 40 億美元，運營基礎上下降 24.8%。美國的侵蝕仍然略好於我們的預期，因為本季度的影響絕大多數是由價格驅動的。

Turning now to hematologic oncology, where total revenues were approaching $1.5 billion. Imbruvica global revenues were $907 million, down 20.8%, consistent with our expectations. Venclexta global sales were $571 million, up 15% on an operational basis with strong demand for both CLL and AML, and we are particularly pleased with the international performance here, following continued reimbursement progress in the EU and inclusion in China's national reimbursement list. We also recently received the U.S. approval for Epkinly in third line plus DLBCL further expanding our on-market portfolio in hem/onc. Early prescription trends have been encouraging, with a more robust opportunity expected as we progress development in earlier lines of therapy. We also anticipate approval and commercialization in Europe and Japan later this year. In neuroscience, revenues were nearly $1.9 billion, up 14.2% on an operational basis.

現在轉向血液腫瘤學，該領域的總收入接近 15 億美元。 Imbruvica 全球收入為 9.07 億美元，下降 20.8%，與我們的預期一致。 Venclexta 全球銷售額為 5.71 億美元，在 CLL 和 AML 需求強勁的情況下增長了 15%，隨著歐盟報銷持續取得進展並納入中國國家報銷清單，我們對國際表現尤其滿意。我們最近還獲得了美國對 Epkinly 的三線治療和 DLBCL 的批准，進一步擴大了我們在 hem/onc 的市場產品組合。早期處方趨勢令人鼓舞，隨著我們在早期療法中取得進展，預計會有更強勁的機會。我們還預計今年晚些時候在歐洲和日本獲得批准和商業化。在神經科學領域，營業收入接近 19 億美元，增長 14.2%。

Vraylar continues to exceed our expectations. Sales of $658 million were up 33.9% on an operational basis with increasing momentum across all indications following the MDD approval late last year. Within migraine, we remain the clear market leader with unique treatment options for both acute and chronic conditions. Our oral CGRP portfolio contributed $292 million in combined sales this quarter reflecting growth of more than 30% as we continue to see strong prescription demand for both Ubrelvy and Qulipta.

Vraylar 繼續超出我們的預期。自去年年底獲得 MDD 批准後，所有適應症的勢頭均呈增長勢頭，營業銷售額達 6.58 億美元，增長了 33.9%。在偏頭痛領域，我們仍然是明顯的市場領導者，為急性和慢性疾病提供獨特的治療方案。我們的口服 CGRP 產品組合本季度貢獻了 2.92 億美元的合併銷售額，增長超過 30%，因為我們繼續看到 Ubrelvy 和 Qulipta 的處方需求強勁。

Lastly, total Botox Therapeutic sales were $748 million, up 11.3% on an operational basis, reflecting nice momentum in chronic migraine as well as other approved indications. This franchise continues to outperform our expectations, and we will be raising our full year guidance for the collective neuroscience portfolio. So overall, I'm extremely pleased with the performance and execution across the therapeutic portfolio with growth expected to accelerate through the second half of the year.

最後，Botox Therapeutics 的總銷售額為 7.48 億美元，運營基礎上增長 11.3%，反映出慢性偏頭痛以及其他批准適應症的良好勢頭。該系列產品的表現繼續超出我們的預期，我們將提高對集體神經科學產品組合的全年指導。總的來說，我對整個治療組合的表現和執行非常滿意，預計下半年增長將加速。

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

這樣，我會將電話轉給 Carrie，以獲取有關美學的更多評論。嘉莉？

Thank you, Jeff. Second quarter global aesthetics sales were approximately $1.4 billion, up 2.9% on an operational basis with strong performance from our international portfolio offsetting the economic impact in the U.S.

謝謝你，傑夫。第二季度全球美容銷售額約為 14 億美元，運營基礎上增長 2.9%，我們的國際產品組合的強勁表現抵消了美國經濟的影響。

U.S. aesthetic sales were $829 million, down 6.2%. Our U.S. portfolio continues to perform well from a competitive perspective. And as expected, the aesthetics markets continued to be impacted by lower consumer spending related to inflationary pressures, which weighed on year-over-year growth rates.

美國美容銷售額為 8.29 億美元，下降 6.2%。從競爭角度來看，我們的美國投資組合繼續表現良好。正如預期的那樣，美容市場繼續受到與通脹壓力相關的消費者支出下降的影響，這拖累了同比增長率。

U.S. Botox cosmetic sales were $420 million, a decline of 6.5% versus the prior year. While the U.S. cosmetic toxin market declined low single digits in the second quarter on a year-over-year basis, growth rates improved through the quarter, with June showing a return to positive year-over-year market growth.

美國Botox化妝品銷售額為4.2億美元，比上年下降6.5%。儘管美國化妝品毒素市場第二季度同比下降了低個位數，但整個季度的增長率有所改善，其中 6 月份市場恢復了同比正增長。

Botox Cosmetic continues to be the clear market leader, maintaining strong and stable share despite new competitive entrants. U.S. Juvederm sales were $125 million, down 14.5% on a year-over-year basis as we continue to see a more pronounced impact from inflationary dynamics on higher-priced, more deferrable procedures such as Filler. The U.S. Filler market declined approximately 20% in the quarter on a year-over-year basis due to the persistent inflationary environment. Our Juvederm collection remains market leader and share was stable in the quarter. The economic metrics that we track for the U.S. have largely stabilized. Our consumer market research shows a meaningful recovery from last summer and those intending to get treated with toxins and fillers. Additionally, we have now lapped the beginning of the market downturn, which occurred in the second quarter of last year. Based on these factors, we expect growth rates for the U.S. facial injectables to improve in the second half of this year.

Botox Cosmetic 仍然是明顯的市場領導者，儘管有新的競爭者進入，但仍保持強勁和穩定的份額。美國 Juvederm 銷售額為 1.25 億美元，同比下降 14.5%，因為我們繼續看到通脹動態對 Filler 等價格更高、更可延期的手術產生更明顯的影響。由於持續的通脹環境，本季度美國填料市場同比下降約 20%。我們的 Juvederm 系列仍然是市場領先者，本季度份額保持穩定。我們追踪的美國經濟指標已基本穩定。我們的消費者市場研究顯示，從去年夏天開始，以及那些打算接受毒素和填充劑治療的消費者出現了有意義的複蘇。此外，我們現在已經度過了去年第二季度發生的市場低迷的開始。基於這些因素，我們預計今年下半年美國面部注射劑的增長率將有所改善。

Our international aesthetics portfolio continues to perform exceptionally well with strong results in many key markets. Second quarter sales were $555 million, reflecting operational growth of nearly 20%. The International Botox cosmetic sales of $265 million increased approximately 14% on an operational basis and International Juvederm sales were $243 million, up approximately 28% on an operational basis.

我們的國際美學產品組合繼續表現出色，在許多關鍵市場取得了強勁的業績。第二季度銷售額為 5.55 億美元，運營增長近 20%。國際 Botox 化妝品銷售額為 2.65 億美元，按運營基礎增長約 14%，國際 Juvederm 銷售額為 2.43 億美元，按運營基礎增長約 28%。

Growth in the Asia Pacific region was particularly robust as aesthetic treatment rates in China have fully recovered to pre-COVID levels. We continue to anticipate strong normalized growth through the remainder of the year in China. We are very pleased with the strong performance of our international aesthetics portfolio over the first half of the year and continue to expect similarly strong results in the second half. In the third quarter, we will be facing a challenging year-over-year comparison due to a shipment timing benefit we saw in the third quarter of 2022. This is expected to result in relatively flat growth for our international portfolio in the third quarter.

由於中國的美容治療率已完全恢復到新冠疫情前的水平，亞太地區的增長尤其強勁。我們繼續預計中國在今年剩餘時間內將實現強勁的正常增長。我們對上半年國際美學產品組合的強勁表現感到非常滿意，並繼續期望下半年取得同樣強勁的業績。在第三季度，由於我們在 2022 年第三季度看到了發貨時間優勢，我們將面臨具有挑戰性的同比比較。這預計將導致我們第三季度的國際投資組合相對平穩的增長。

On a full year basis, we expect our international aesthetics sales to grow high single digits. We continue to invest to drive future growth for our aesthetics portfolio with a focus on enhanced promotional activities improve digital products and services through our Alle platform, Salesforce expansion and injector training. We continue to invest in our pipeline as well. And we remain committed to a regular cadence of new product introductions and indication expansions for Botox cosmetic in Juvederm.

全年來看，我們預計我們的國際美容銷售額將實現高個位數增長。我們繼續投資以推動我們的美容產品組合的未來增長，重點是加強促銷活動，通過我們的 Alle 平台、Salesforce 擴展和注射器培訓改進數字產品和服務。我們也繼續投資於我們的管道。我們仍然致力於定期推出 Juvederm 的 Botox 化妝品新產品和適應症擴展。

We recently announced the FDA approval of SkinVive the first hyaluronic acid Filler in the U.S. for improved skin smoothness of the cheeks, which, along with the recently launched Volux Filler for jawline contouring will help sustain our leadership position in the U.S. Filler market. Our investments will allow us to maintain a strong leadership position in the highly underpenetrated and rapidly growing global aesthetics markets. We remain very confident in the long-term outlook for our aesthetics portfolio and continue to expect to deliver greater than $9 billion in 2029. In the near term, the improving aesthetics outlook in the U.S. and continued robust international performance gives us confidence to once again raise our full year aesthetics guidance with an expectation for continued operational growth over the back half of the year.

我們最近宣布 FDA 批准 SkinVive，這是美國第一個用於改善臉頰皮膚光滑度的透明質酸填充劑，它與最近推出的用於下頜輪廓的 Volux Filler 一起將有助於維持我們在美國填充劑市場的領導地位。我們的投資將使我們能夠在高度滲透且快速增長的全球美容市場中保持強大的領導地位。我們對美容產品組合的長期前景仍然充滿信心，並繼續預計 2029 年將實現超過 90 億美元的收入。短期內，美國美容前景的改善和持續強勁的國際表現讓我們再次有信心提高我們的全年美學指導，預計下半年運營將持續增長。

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

這樣，我就把電話轉給湯姆。

Thank you, Carrie. We've continued to make very good progress with our pipeline over the quarter. We had a substantial amount of activity across our R&D pipeline, resulting in new approvals and advancements of several programs.

謝謝你，嘉莉。本季度我們的管道繼續取得良好進展。我們在整個研發管道中開展了大量活動，導致多個項目獲得新的批准和進展。

In immunology, we received FDA approval for Rinvoq in Crohn's disease, marking its seventh FDA approval across gastroenterology, rheumatology and dermatology. In our Crohn's development program, Rinvoq demonstrated a very rapid and strong impact on symptoms as well as endoscopic improvement. Given its strong benefit risk profile, we believe Rinvoq will be an important new medicine for patients suffering from moderate to severe Crohn's disease. While Crohn's disease approval marks the completion of the core indications, we believe Rinvoq has this -- the potential to become a highly effective therapy in several additional important diseases. We recently began Phase III studies for Rinvoq in systemic lupus, a hidradenitis, suppurativa, and we remain on track to begin Phase III studies in Alopecia areata later this year.

在免疫學領域，我們的 Rinvoq 治療克羅恩病獲得 FDA 批准，這是 FDA 在胃腸病學、風濕病學和皮膚病學領域第七次獲得批准。在我們的克羅恩病開發計劃中，Rinvoq 表現出對症狀以及內窺鏡改善的非常快速和強烈的影響。鑑於其強大的獲益風險特徵，我們相信 Rinvoq 將成為患有中度至重度克羅恩病患者的重要新藥。雖然克羅恩病的批准標誌著核心適應症的完成，但我們相信 Rinvoq 有潛力成為幾種其他重要疾病的高效療法。我們最近開始了 Rinvoq 治療系統性狼瘡、汗腺炎、化膿性的 III 期研究，並且我們仍有望在今年晚些時候開始斑禿的 III 期研究。

We'll also see later this year from a Phase II study in vitiligo, which could support advancement to Phase III in this indication as well.

我們還將在今年晚些時候看到白癜風的 II 期研究，該研究也可以支持該適應症進入 III 期研究。

Moving to Skyrizi, where in the quarter, we announced positive top line results from our Phase III maintenance trial in ulcerative colitis. In this study, Skyrizi met the primary and key secondary end points at week 52 compared to the withdrawal arm, demonstrating that patients continuing treatment with Skyrizi maintain high levels of clinical remission as well as more stringent endpoints such as endoscopic improvement, histologic endoscopic mucosal improvement and steroid-free remission.

轉向 Skyrizi，本季度我們宣布了潰瘍性結腸炎 III 期維持試驗的積極頂線結果。在這項研究中，與停藥組相比，Skyrizi 在第 52 周達到了主要和關鍵次要終點，表明繼續接受 Skyrizi 治療的患者保持了高水平的臨床緩解以及更嚴格的終點，例如內窺鏡改善、組織學內窺鏡粘膜改善和無類固醇緩解。

It's important to note that approximately 75% of the patients in this study had failed advanced therapy, including not only anti-TNFs, but also other biologics, JAK inhibitors and S1P modulators. This represents a very difficult-to-treat population in ulcerative colitis. Skyrizi's strong performance in patients with and without failure to advanced therapies including patients who were naive to advanced therapy demonstrate its utility across the spectrum of moderate to severe UC patients. We remain on track to submit our regulatory applications in the third quarter with approvals anticipated in 2024.

值得注意的是，這項研究中大約 75% 的患者接受了先進治療失敗，這些治療不僅包括抗 TNF 藥物，還包括其他生物製劑、JAK 抑製劑和 S1P 調節劑。這代表了潰瘍性結腸炎中非常難以治療的人群。 Skyrizi 在接受過或未接受過高級治療的患者（包括未接受過高級治療的患者）中的強勁表現證明了其在中度至重度 UC 患者中的實用性。我們仍有望在第三季度提交監管申請，預計將於 2024 年獲得批准。

We also recently published results from a head-to-head trial comparing Skyrizi to Otezla in patients with moderate psoriasis with Skyrizi demonstrating clear superiority to Otezla on all primary and ranked secondary endpoints at week 16 and 52. At week 52 of this study, 64% of patients achieved absolute skin clearance as measured by PASI 100 an sPGA clear compared to just 3% for Otezla, underscoring Skyrizi's ability to drive very high and durable responses in these moderate patients.

我們最近還發表了一項頭對頭試驗的結果，該試驗在中度銀屑病患者中比較了 Skyrizi 和 Otezla，在第 16 周和第 52 週，Skyrizi 在所有主要終點和排名次要終點上均明顯優於 Otezla。在本研究的第 52 週，64 % 的患者實現了 PASI 100 和 sPGA 清除的絕對皮膚清除率，而 Otezla 的這一比例僅為 3%，這突顯了 Skyrizi 在這些中度患者中產生非常高且持久的反應的能力。

In addition to higher clinical efficacy outcomes, the patients treat with Skyrizi which is a self-injectable administered quarterly reported improvements in health-related quality of life measures and greater treatment satisfaction compared to those treated with Otezla, which is an oral administered twice daily. Additionally, Skyrizi demonstrated favorable safety and tolerability compared to Otezla. The rates of adverse events, including serious and severe AEs were numerically higher with Otezla than with Skyrizi treatment. Previous to -- similar to previous studies, Otezla treatment was associated with high rates of gastrointestinal distress such as nausea, diarrhea and vomiting, which resulted in a 7% discontinuation rate in the first 16 weeks of treatment compared to no discontinuations for Skyrizi patients.

除了更高的臨床療效結果之外，與接受每天兩次口服給藥的 Otezla 治療的患者相比，接受 Skyrizi（一種每季度注射一次的自我注射劑）治療的患者報告稱，與健康相關的生活質量指標有所改善，並且治療滿意度更高。此外，與 Otezla 相比，Skyrizi 表現出良好的安全性和耐受性。 Otezla 治療的不良事件（包括嚴重和重度 AE）發生率在數量上高於 Skyrizi 治療。與之前的研究類似，Otezla 治療與噁心、腹瀉和嘔吐等胃腸道不適發生率較高有關，導致治療前 16 週內有 7% 的停藥率，而 Skyrizi 患者則沒有停藥。

We're incredibly pleased with these results, which further underscores Skyrizi's position as the best in category treatment for moderate-to-severe psoriasis, providing very high efficacy, durable responses a safe and tolerable profile and convenient quarterly administration.

我們對這些結果感到非常滿意，這進一步強調了 Skyrizi 作為中重度銀屑病最佳治療藥物的地位，提供非常高的療效、持久的反應、安全和可耐受的特徵以及方便的季度給藥。

In oncology, we received accelerated approval in the U.S. for Epkinly as a monotherapy treatment for patients with relapsed or refractory DLBCL who had received 2 or more systemic therapies. We also recently received positive CHMP opinion with an approval decision in Europe expected later this year. DLBCL is a very aggressive disease where later-line patients have limited options. We're extremely excited to bring this new subcutaneous treatment option to patients. In the quarter, we also announced positive top line results from the follicular lymphoma cohort of a Phase II trial evaluating Epkinly in patients who have received at least 2 [prior lines] of therapy. In this study, Epkinly performed very well as a monotherapy, demonstrating an overall response rate of 82%.

在腫瘤學方面，我們在美國加速批准 Epkinly 作為單一療法治療已接受 2 種或以上全身治療的複發性或難治性 DLBCL 患者。我們最近還收到了 CHMP 的積極意見，預計將於今年晚些時候在歐洲做出批准決定。 DLBCL 是一種侵襲性很強的疾病，晚期患者的選擇有限。我們非常高興能為患者帶來這種新的皮下治療選擇。在本季度，我們還宣布了一項 II 期試驗的濾泡性淋巴瘤隊列的積極頂線結果，該試驗在至少接受過 2 種[先前線]治療的患者中評估 Epkinly。在這項研究中，Epkinly 作為單一療法表現非常好，總體緩解率為 82%。

We are pleased these results and plan to discuss these data with regulatory agencies about the potential to support a submission for accelerated approval. Beyond the mid-stage studies supporting accelerated approvals in [later lines] of therapy. We also have Phase III trials ongoing in earlier lines of DLBCL and for lymphoma, and we look forward to providing updates on these programs as the data mature.

我們對這些結果感到高興，併計劃與監管機構討論這些數據，探討支持加速批准提交的潛力。除了支持加速批准[後期]治療的中期研究之外。我們還在早期 DLBCL 和淋巴瘤系列中正在進行 III 期試驗，我們期待隨著數據成熟提供這些項目的更新。

In our Navitoclax program, we recently saw top line results from the Phase III TRANSFORM 1 trial, evaluating Navitoclax in combination with ruxolitinib in for patients with treatment naive myelofibrosis. This study met the primary endpoint at week 24, demonstrating a statistically significant improvement in the percentage of patients who achieved complete volume reduction of at least 35% compared to Rux plus placebo. For the primary endpoint, the Navitoclax combination showed a doubling of improvement over Rux alone with 63% of patients on the Navitoclax combination achieving SVR35 compared to 32% in the Rux plus placebo combination. In this study, the Navitoclax combination did not achieve the first ranked secondary endpoint, which was improvement in total symptom score at week 24. We additional follow-up data on SVR and TSS as well as other endpoints are expected in the fourth quarter of this year. We plan to wait for these more mature data before engaging with regulatory agencies in order to have a more comprehensive picture of the patient's clinical response and clinical benefit that Navitoclax can provide.

在我們的 Navitoclax 項目中，我們最近看到了 III 期 TRANSFORM 1 試驗的主要結果，該試驗評估了 Navitoclax 與魯索替尼聯合治療對初治骨髓纖維化患者的療效。這項研究在第 24 周達到了主要終點，表明與 Rux 加安慰劑相比，實現體積完全減少至少 35% 的患者百分比有統計學上的顯著改善。對於主要終點，Navitoclax 組合的改善效果比單用 Rux 翻倍，使用 Navitoclax 組合的患者有 63% 達到 SVR35，而 Rux 加安慰劑組合的患者為 32%。在這項研究中，Navitoclax 組合沒有達到排名第一的次要終點，即第 24 週總症狀評分的改善。我們預計在本研究第四季度獲得有關 SVR 和 TSS 以及其他終點的額外後續數據。年。我們計劃等待這些更成熟的數據，然後再與監管機構合作，以便更全面地了解患者的臨床反應和 Navitoclax 可以提供的臨床益處。

Looking to the remainder of this year. We remain on track for several additional data readouts from our late-stage oncology programs, including Phase III data from Venclexta's CANOVA trial in relapsed/refractory multiple myeloma patients with t(1114) mutation. As a reminder, this is an event-driven study, and we're just waiting -- we're waiting for just a handful of remaining events. So we'd expect to have these data in-house in the coming months. And we remain on track to see Phase II data for Teliso-V in second-line plus advanced non-squamous non-small cell lung cancer in the fourth quarter. We're also making very good progress with several earlier line, earlier stage solid tumor programs. We recently initiated a Phase II study for ABBV-151, our anti-GARP antibody in Hepatocellular carcinoma and plan to begin Phase II in several additional solid tumors over the course of the next 12 months.

展望今年剩餘時間。我們仍在跟踪後期腫瘤學項目的一些額外數據讀數，包括來自 Venclexta 的 CANOVA 試驗的 III 期數據，該試驗針對具有 t(1114) 突變的複發/難治性多發性骨髓瘤患者。提醒一下，這是一項事件驅動的研究，我們只是在等待——我們只是在等待少數剩餘的事件。因此，我們預計將在未來幾個月內獲得這些數據。我們仍有望在第四季度看到 Teliso-V 在二線及晚期非鱗狀非小細胞肺癌中的 II 期數據。我們在幾個早期線、早期實體瘤項目上也取得了非常好的進展。我們最近啟動了 ABBV-151（我們在肝細胞癌中的抗 GARP 抗體）的 II 期研究，併計劃在未來 12 個月內開始在其他幾個實體瘤中進行 II 期研究。

At the recent ASCO meeting, we presented promising initial results from a Phase I study evaluating our next-generation c-Met ADC, ABBV-400 in several advanced solid tumor types. We're seeing responses across multiple tumors, indicating broad activity. Results in late-line colorectal patients were particularly encouraging, where monotherapy treatment with 400 resulted in a confirmed overall response rate of 22% well in excess of standard of care, which is typically less than 2% to 3%. We're also encouraged by the doability of response seen in these early results. These patients had an average of 5 prior lines of therapy, so this level of efficacy is very encouraging. Based on these results, we plan to start our Phase II program later this year, beginning with a second line colorectal cancer study.

在最近的 ASCO 會議上，我們展示了一項 I 期研究的有希望的初步結果，該研究評估了我們的下一代 c-Met ADC ABBV-400 在幾種晚期實體瘤類型中的作用。我們看到多個腫瘤都有反應，表明活性廣泛。晚期結直腸患者的結果尤其令人鼓舞，其中 400 的單藥治療導致確認的總體緩解率為 22%，遠遠超過護理標準，通常低於 2% 至 3%。我們還對這些早期結果中所看到的響應的可行性感到鼓舞。這些患者之前平均接受過 5 種治療，因此這種療效水平非常令人鼓舞。基於這些結果，我們計劃在今年晚些時候啟動我們的二期項目，從二線結直腸癌研究開始。

Now moving to neuroscience, where in the quarter, we received a positive CHMP opinion recommending approval of atogepant for migraine prevention. We anticipate a decision in the coming months. And if approved, atogepant would be the only oral CGRP antagonist approved in Europe for prevention of both episodic and chronic migraine. This is a debilitating condition that impacts tens of millions of people in Europe, and we look forward to making this new oral treatment option available to patients once approved.

現在轉向神經科學，在本季度，我們收到了 CHMP 的積極意見，建議批准 atogepant 用於預防偏頭痛。我們預計將在未來幾個月內做出決定。如果獲得批准，atogepant 將成為歐洲唯一批准用於預防陣發性和慢性偏頭痛的口服 CGRP 拮抗劑。這是一種使人衰弱的疾病，影響著歐洲數千萬人，我們期待在獲得批准後為患者提供這種新的口服治療選擇。

Also in the area of neuroscience, ABBV-916, our Abeta antibody for Alzheimer's disease is rapidly advancing to dose escalation studies. This antibody is demonstrating a long half-life and very low antidrug antibodies, both important attributes to achieve a best-in-class profile for our Abeta antibody. Dose selection in Phase II is expected to begin early next year. And lastly, in our aesthetics pipeline, we recently submitted our regulatory application for Botox in masseter muscle prominence in China, which is the initial focus for our program given the prevalence of masseter muscle prominence in Asian populations and a significant unmet need for minimally invasive treatment options.

同樣在神經科學領域，我們針對阿爾茨海默病的 Abeta 抗體 ABBV-916 正在迅速推進劑量遞增研究。該抗體具有較長的半衰期和非常低的抗藥抗體，這兩個特性對於我們的 Abeta 抗體實現一流的特性來說都是重要的屬性。第二階段的劑量選擇預計將於明年初開始。最後，在我們的美容產品線中，我們最近提交了肉毒桿菌在中國治療咬肌突出症的監管申請，鑑於亞洲人群咬肌突出症的普遍性以及對微創治療的重大未滿足的需求，這是我們項目的最初重點選項。

In our Platysma prominence program for Botox, we remain on track to see data from 2 additional Phase III studies later this year with our regulatory submission in the U.S. expected near the end of the year. So in summary, we had a very productive first half of the year across all stages and therapeutic areas of our pipeline, and we look forward to the second half of 2023 with several important clinical and regulatory milestones.

在我們針對 Botox 的 Platysma 突出計劃中，我們仍有望在今年晚些時候看到另外兩項 III 期研究的數據，預計我們將在年底向美國監管機構提交申請。總而言之，今年上半年我們在管道的所有階段和治療領域都取得了非常富有成效的成果，我們期待 2023 年下半年實現幾個重要的臨床和監管里程碑。

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

這樣，我會將電話轉給斯科特。

Thank you, Tom. I'm very pleased with the performance and outlook of the business, including the strong momentum from our ex-Humira growth plan.

謝謝你，湯姆。我對公司的業績和前景感到非常滿意，包括我們的前 Humira 增長計劃帶來的強勁勢頭。

Starting with our second quarter results. We reported adjusted earnings per share of $2.91, which is $0.11 above our guidance midpoint. These results include a $0.15 unfavorable impact from acquired IP R&D expense. Total net revenues were nearly $13.9 billion, more than $350 million ahead of our guidance and down 4.2% on an operational basis, excluding a 0.7% unfavorable impact from foreign exchange.

從我們第二季度的業績開始。我們公佈的調整後每股收益為 2.91 美元，比我們的指導中值高出 0.11 美元。這些結果包括收購的知識產權研發費用帶來的 0.15 美元不利影響。總淨收入接近 139 億美元，比我們的指引高出 3.5 億美元以上，並且在運營基礎上下降 4.2%（不包括 0.7% 的外匯不利影響）。

Importantly, these results reflect high single-digit sales growth from our growth platform. The adjusted operating margin ratio was 47% of sales. This includes adjusted gross margin of 84.7% of sales, adjusted R&D investment of 12.5% of sales, acquired IP R&D expense of 2% of sales and adjusted SG&A expense of 23.2% of sales. Net interest expense was $454 million, the adjusted tax rate was 15.8%.

重要的是，這些結果反映了我們的增長平台的高個位數銷售增長。調整後的營業利潤率為銷售額的47%。其中包括調整後的毛利率佔銷售額的 84.7%、調整後的研發投資佔銷售額的 12.5%、收購的知識產權研發費用佔銷售額的 2% 以及調整後的 SG&A 費用佔銷售額的 23.2%。淨利息支出為4.54億美元，調整後稅率為15.8%。

Turning to our financial outlook. We are raising the midpoint of our full year adjusted earnings per share guidance by $0.23 and now expect adjusted earnings per share between $10.90 and $11.10. This guidance does not include an estimate for acquired IP R&D expense that may be incurred beyond the second quarter. We now expect total net revenues of approximately $53.4 billion, an increase of $1 billion. At current rates, we expect foreign exchange to have a modest unfavorable impact on full year sales growth. This guidance includes the following updated assumptions with more than half of the sales improvement attributed to our ex-Humira growth platform.

轉向我們的財務前景。我們將全年調整後每股收益指引的中點上調 0.23 美元，目前預計調整後每股收益在 10.90 美元至 11.10 美元之間。本指南不包括對第二季度之後可能發生的收購知識產權研發費用的估計。我們現在預計總淨收入約為 534 億美元，增加 10 億美元。按照目前的匯率，我們預計外匯將對全年銷售增長產生適度的不利影響。該指南包括以下更新的假設，其中一半以上的銷售增長歸因於我們的前 Humira 增長平台。

We now expect Skyrizi global sales of approximately $7.6 billion, an increase of $200 million due to continued strong performance across all approved indications. We now expect neuroscience sales of approximately $7.7 billion, an increase of $300 million, reflecting robust prescription growth for Vraylar following the MDD approval as well as better-than-expected performance of Botox Therapeutics and Qulipta. And for aesthetics, we now expect global revenue of approximately $5.4 billion, an increase of $100 million, primarily reflecting momentum from Botox Cosmetic. Lastly, we now anticipate U.S. Humira erosion of approximately 35%, resulting in a sales guidance increase of $400 million based on volume trends and strong parity access.

我們目前預計 Skyrizi 全球銷售額約為 76 億美元，由於所有批准適應症的持續強勁表現，該銷售額將增加 2 億美元。我們目前預計神經科學銷售額約為 77 億美元，增加 3 億美元，反映出 MDD 批准後 Vraylar 處方藥的強勁增長以及 Botox Therapeutics 和 Qulipta 的業績好於預期。在美容方面，我們現在預計全球收入約為 54 億美元，增加 1 億美元，主要反映了 Botox Cosmetic 的增長勢頭。最後，我們現在預計美國 Humira 的侵蝕約為 35%，根據銷量趨勢和強大的平價准入，銷售指導將增加 4 億美元。

Moving to the P&L. We continue to anticipate adjusted gross margin of 84% of sales and now expect adjusted R&D expense of $6.9 billion, SG&A expense of $12.7 billion and an adjusted operating margin ratio of approximately 46.5% of sales.

轉向損益表。我們繼續預計調整後的毛利率將達到銷售額的 84%，目前預計調整後的研發費用為 69 億美元，SG&A 費用為 127 億美元，調整後的營業利潤率約為銷售額的 46.5%。

Turning to the third quarter. We anticipate net revenues of approximately $13.7 billion, which includes U.S. Humira erosion of approximately 40%. And rates, we expect foreign exchange to have a modest unfavorable impact on sales growth. We expect adjusted earnings per share between $2.80 and $2.90. This guidance does not include acquired IP R&D expense that may be incurred in the quarter.

轉向第三季度。我們預計淨收入約為 137 億美元，其中美國修美樂 (Humira) 的侵蝕約為 40%。就利率而言，我們預計外匯將對銷售增長產生適度的不利影響。我們預計調整後每股收益在 2.80 美元至 2.90 美元之間。本指引不包括本季度可能發生的收購知識產權研發費用。

In closing, AbbVie has once again delivered strong top and bottom line performance, and we are very pleased with the momentum of the business heading into the second half of the year.

最後，艾伯維再次實現了強勁的營收和淨利潤表現，我們對進入今年下半年的業務勢頭感到非常滿意。

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

這樣，我會將電話轉回給莉茲。

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

謝謝，斯科特。我們現在將開始提問，以便在電話會議的剩餘時間內聽取盡可能多的分析師的意見，我們要求您將問題限制為 1 或 2 個。接線員，我們將回答第一個問題。

Vamil Divan, Guggenheim Securities. .

瓦米爾·迪萬，古根海姆證券公司。 。

So one, I'm just curious, given the strong quarter and the guidance raise, in terms of that you talked about your floor EPS, is that -- do you still see a floor of $10.70 or is it different? And can you talk anymore at this point or when you see that floor happening? And then my second question is around IRA, and you obviously a lot of focus there. I'm curious if you have any thoughts around if we look at the first list of products around September 1. Are you expecting AbbVie products to be included in that first group of 10.

所以，我只是很好奇，考慮到強勁的季度和指導性的提高，就您談到的每股收益底線而言，您是否仍認為底線為 10.70 美元，還是有所不同？此時或者當您看到該樓層正在發生時，您還能再說話嗎？我的第二個問題是關於 IRA 的，顯然您非常關注這一點。我很好奇，如果我們在 9 月 1 日左右查看第一批產品清單，您是否有任何想法。您是否期望艾伯維 (AbbVie) 產品包含在第一組 10 種產品中。

And then infused just on Rinvoq specifically and how you see that might be at risk from IRA, given you bring obviously a lot of life cycle development there. And is there a chance that a life cycle may not be quite as long? Or kind of how are you thinking about prioritizing investing in a small molecule like Rinvoq?

然後專門在 Rinvoq 上註入，以及您如何看待 IRA 可能面臨的風險，因為您顯然在那裡帶來了很多生命週期開發。生命週期是否有可能不會那麼長？或者您如何考慮優先投資像 Rinvoq 這樣的小分子？

Vamil, this is Rick. I'll take the first question and then maybe Rob and I can also tag team on the first one and the second one as well. So if you look at the floor, if you step back and look at how the business is performing. Obviously, the business is performing extremely well. And a significant part of the over achievement is not the Humira business. In fact, of the $1.4 billion we're raising, as Scott said, only $400 million of it is Humira. So $1 billion of it is the growth platform.

瓦米爾，這是瑞克。我會回答第一個問題，然後也許羅伯和我也可以在第一個問題和第二個問題上標記團隊。因此，如果你看看地板，如果你退一步看看業務的表現如何。顯然，該業務的表現非常出色。超額成就的一個重要部分並不是 Humira 業務。事實上，正如斯科特所說，在我們籌集的 14 億美元中，只有 4 億美元是 Humira。因此，其中 10 億美元是增長平台。

So all that speaks. We have very strong momentum going into 2024. And we talked before on these calls about, well, when will the trough year occur. And as you think about the floor, I think you have to sort of think about the trough year at the same time. We said in the past that if we significantly overachieved in 2023, that would increase the probability that the trough year was in 2024. And we said that in the backdrop of primarily thinking about it as Humira overachieving. And obviously, now what we're seeing that it's the majority of the other products that are overachieving the growth platform.

所以說的都是這些。進入 2024 年，我們的勢頭非常強勁。我們之前在這些電話會議上討論過，低谷年何時會發生。當你考慮地板時，我認為你必須同時考慮低谷年份。我們過去曾說過，如果我們在 2023 年取得了顯著的超額業績，那麼 2024 年是低谷年的可能性就會增加。我們說這番話的背景主要是認為修美樂（Humira）取得了超額業績。顯然，現在我們看到的是大多數其他產品都超出了增長平台。

So as we look at '24 and as we look at the trough, I think we have to let the year play out a little bit further to see where we're going. But I would say that we're feeling pretty -- we're feeling very good about '24. And the growth of that non-Humira business could more than offset the over performance that we're seeing this year, especially the over performance that we're seeing on Humira. So it's too early to raise the floor. But what I would tell you is the performance that we're seeing now gives us a tremendous amount of confidence of what '24 looks like. Rob, anything you'd add?

因此，當我們展望 24 年以及低谷時，我認為我們必須讓這一年繼續發展下去，看看我們將走向何方。但我想說我們感覺很好——我們對 24 感覺非常好。非 Humira 業務的增長可能足以抵消我們今年看到的超額業績，尤其是我們在 Humira 上看到的超額業績。因此現在提出意見還為時過早。但我要告訴你的是，我們現在看到的表現讓我們對 '24 的樣子充滿了信心。羅布，你還有什麼要補充的嗎？

I'd just add that we've now collectively raised revenue guidance by $1.4 billion, as Rick mentioned, we raised $400 million in the first quarter, $1 billion this quarter. When you look at it, it's really across the key therapeutic areas that will drive long-term growth. We've raised Skyrizi, aesthetics, neuroscience, and also Humira. So we do feel very good about the performance of the business. We've debated when we update the floor that will come at some point may not come until we actually give the Q4 guidance -- on the Q4 call of 2024 guidance, but as we look at it, the fundamentals of the business are very, very strong, and we're seeing performance across all of the therapeutic areas.

我想補充一點，我們現在已經將收入指引集體提高了 14 億美元，正如 Rick 提到的，我們在第一季度籌集了 4 億美元，本季度籌集了 10 億美元。當你仔細觀察時，你會發現它確實跨越了將推動長期增長的關鍵治療領域。我們提出了 Skyrizi、美學、神經科學以及 Humira。所以我們對業務的表現確實感覺非常好。我們一直在爭論何時更新下限，但在我們真正給出第四季度指導之前（在 2024 年第四季度電話會議上發布指導），可能不會出現這一情況，但當我們看到它時，業務的基本面非常，非常強勁，我們看到了所有治療領域的表現。

On your second question, IRA. I think it's very difficult to predict. In our planning assumptions, we have assumed for some products to be impacted here early on. Imbruvica is obviously one product that we're looking at carefully. I would say it's right from how you would calculate it based on the data that we would have, it would be right on the bubble of where the cutoff would occur in those first 10 products.

關於你的第二個問題，IRA。我認為這很難預測。在我們的規劃假設中，我們已經假設某些產品很早就會受到影響。 Imbruvica 顯然是我們正在仔細研究的一種產品。我想說，根據我們現有的數據計算它是正確的，它就在前 10 個產品中發生截止的泡沫上。

So it could be 10, it could be 9, it could be 11, depending upon how some other products. And I say it that way because remember, we're using the data that we have, we're not 100% sure that, that is the data that CMS is going to use. So there's not perfect clarity around it. But I would say that's one that we obviously have on the radar screen and we're looking at carefully. Anything you'd add, Rob?

所以它可能是 10、可能是 9、可能是 11，具體取決於其他產品的情況。我這樣說是因為請記住，我們正在使用現有的數據，但我們不能 100% 確定 CMS 將使用這些數據。所以它並不完全清晰。但我想說，這顯然是我們雷達屏幕上的一個，我們正在仔細觀察。羅布，你還有什麼要補充的嗎？

When IRA was passed a year ago, we obviously modeled the impact and we reaffirmed the long-term guidance expectation of high single-digit growth in the second half of this decade. That remains. We looked at what it means in terms of inflation penalties, party benefit redesign, negotiations. So we did make assumptions around that. I think Rick is correct in that there is still enough uncertainty we're going to know soon, right? September 1 is when they expect to announce the first list.

一年前通過 IRA 時，我們顯然對其影響進行了建模，並重申了本十年後半期高個位數增長的長期指導預期。剩下的就是這個了。我們研究了它在通貨膨脹懲罰、政黨福利重新設計和談判方面的意義。所以我們確實對此做出了假設。我認為里克是正確的，因為我們很快就會知道仍然存在足夠的不確定性，對嗎？他們預計 9 月 1 日將公佈第一份名單。

We have modeled it, but we feel good even with IRA although it does have an impact . It has impacted everyone in the industry, we can still deliver on our long-term growth expectations. On your question -- and I think keep in mind, too, when you look at the Medicare percent of business for AbbVie. In the U.S., it's about 20%. Globally, it's a little bit lower, obviously. And so you look at us relative to our peers, we have a lower percent of the business as exposed to Medicare.

我們已經對其進行了建模，但即使使用 IRA，我們也感覺良好，儘管它確實有影響。它影響了行業中的每個人，我們仍然可以實現我們的長期增長預期。關於你的問題——當你查看艾伯維的醫療保險業務百分比時，我想也請記住。在美國，這一比例約為 20%。顯然，從全球範圍來看，這個數字要低一些。因此，與同行相比，我們的業務中接受醫療保險的比例較低。

And then when we look at specific at Rinvoq, I think you have to keep in mind with Rinvoq with indication expansion, the percent of sales you're talking about by the time it potentially be selected for negotiation, potentially in the later part of the decade, you're talking about something where like 10% to 12% because if you keep in mind, new indications, in many cases, serve younger patient population. And so that's the way we're looking at Rinvoq continuing to develop it. We obviously have a number of indications that could launch later in the decade. We feel very good about that. those indications can collectively contribute a couple of billion dollars of revenue. We'll continue to drive that robust growth we expect from Rinvoq and Skyrizi as well. And so, even we've modeled the impact of IRA, we don't expect it to impact the development plans for Rinvoq.

然後，當我們查看 Rinvoq 的具體情況時，我認為您必須牢記 Rinvoq 的適應症擴展，即您所談論的銷售百分比，它可能被選擇進行談判，可能是在談判的後期。十年，你談論的是 10% 到 12% 左右的東西，因為如果你記住的話，在許多情況下，新的適應症是為年輕的患者群體服務的。這就是我們看待 Rinvoq 繼續開發它的方式。顯然，我們有許多跡象可能會在本十年晚些時候推出。我們對此感覺非常好。這些跡象總共可以貢獻數十億美元的收入。我們將繼續推動 Rinvoq 和 Skyrizi 的強勁增長。因此，即使我們已經對 IRA 的影響進行了建模，我們也不認為它會影響 Rinvoq 的開發計劃。

Thank you, Vamil. Operator, next question, please.

謝謝你，瓦米爾。接線員，請下一個問題。

Chris Schott, JPMorgan.

克里斯·肖特，摩根大通。

Just two questions for me. I guess first, can you just elaborate in terms of what you're seeing with biosimilar Humira as we think about kind of the price and volume dynamics. I guess specifically, any surprises from your side in terms of how this is playing out? And then just any qualitative comments you can provide about how you see this kind of translating as we kind of think out to 2024? And then my second question was just on the Skyrizi updated guidance. Just a little bit more color on that $7.6 billion of at this point, how much is coming from psoriasis versus psoriatic arthritis versus this Crohn's launch that seems to be off to such a strong start. So just directional color of like the mix of the indications would be very helpful.

對我來說只有兩個問題。我想首先，當我們考慮價格和銷量動態時，您能否詳細說明一下您對生物仿製藥 Humira 的看法。我想具體來說，您對此事的進展有什麼意外嗎？然後，您可以就我們對 2024 年的設想如何看待這種翻譯提供任何定性評論嗎？然後我的第二個問題是關於 Skyrizi 更新的指南。目前，這 76 億美元的資金有多少來自銀屑病、銀屑病關節炎，以及克羅恩病的推出，這似乎有一個良好的開端。因此，像指示的混合那樣的定向顏色會非常有幫助。

Yes. Chris, it's Jeff. And I'll answer your first question. So in a nutshell, we haven't been surprised at any of the dynamics that we've seen play out, we've called it very, very accurately. So again, nothing that's really other than some small volume holding on a little bit better that's really different. So we're quite pleased with how our contracting and access has played out. And that parity access for Humira has been important.

是的。克里斯，是傑夫。我會回答你的第一個問題。簡而言之，我們對所看到的任何動態都沒有感到驚訝，我們非常非常準確地稱之為。再說一次，除了一些小成交量保持得更好一點之外，沒有什麼真正不同的。因此，我們對簽約和訪問的效果非常滿意。 Humira 的平價使用非常重要。

And again, it's what we believe would happen -- we think it's good for patients, obviously, who can maintain their therapy with very little volatility, and it certainly provided us with a lot of predictability. And so I think we've managed sort of the first half with the Amgen launch and then the second half dynamics very, very well. And if you look to '24, as I've highlighted before, we do have 2-year agreements with some of our accounts.

再說一遍，這就是我們相信會發生的事情——顯然，我們認為這對患者有好處，他們可以在波動很小的情況下維持治療，而且它確實為我們提供了很多可預測性。因此，我認為我們在安進的推出方面已經完成了上半年的工作，然後下半年的動態也非常非常好。如果你看看 24 年，正如我之前強調的那樣，我們確實與一些賬戶簽訂了 2 年協議。

And we negotiated those in good faith, and we expect them to be honored. And remember, these are parity contracts for both '23 and '24 and with Humira access coexisting with these multiple biosimilars. So I would say based on these dynamics, we're confident that Humira access will remain quite meaningful in 2024. And we know that as more biosimilars become established, we're also, as we've highlighted, appropriately planning for some volume loss in those certain so-called wax-sensitive accounts over time. So really no surprises in terms of what we've seen overall. So we're quite pleased.

我們是真誠地進行談判的，我們希望他們能夠得到尊重。請記住，這些是 '23 和 '24 的平價合同，並且 Humira 與這些多種生物仿製藥共存。因此，我想說，基於這些動態，我們相信 Humira 的使用在 2024 年仍將非常有意義。而且我們知道，隨著更多生物仿製藥的出現，正如我們所強調的那樣，我們也在適當計劃一些銷量損失隨著時間的推移，在那些所謂的蠟敏感賬戶中。因此，就我們所看到的總體情況而言，確實沒有什麼意外。所以我們很高興。

Chris, this is Rob. Just to give you some color, both in terms of the '23 guidance and the erosion assumptions around that, and then I'll talk about '24 briefly as well. In the first half of the year, obviously, the vast majority of that erosion came from price. We saw very little volume impact. But now with 8 biosimilars on the market and some pursuing a low act strategy, we have assumed high single-digit volume erosion in the second half of the year, which would put the full year volume impact at mid-single digits.

克里斯，這是羅布。只是為了給大家提供一些關於“23 年指導”和相關侵蝕假設的信息，然後我也會簡要討論“24 年”。顯然，今年上半年，絕大多數侵蝕來自價格。我們看到銷量影響非常小。但現在市場上有 8 種生物仿製藥，其中一些採取低劑量策略，我們假設今年下半年的銷量會出現高個位數的侵蝕，這將使全年銷量影響達到中個位數。

The rest of the 35% comes from prices. We've negotiated those higher rebates and maintain strong parity access. Now while we're not providing '24 guidance today for U.S. Humira, it is reasonable to assume that there will be additional price erosion. Some will come from the annualization of the rebates that increased in the second half of this year and some will come from rebate increases negotiated for 2024 parity access. I'd also expect more volume erosion in '24, given the midyear entry of biosimilars this year, especially those that are pursuing a low act strategy. We've taken a close look at consensus estimates, analyst estimates have a very wide range the difference between the lowest estimate and the highest estimate approach is $4 billion.

剩下的35%來自於價格。我們已經協商了更高的回扣並保持強大的平價准入。現在，雖然我們今天沒有為美國 Humira 提供 24 日指導，但可以合理地假設將會出現額外的價格侵蝕。其中一些將來自今年下半年增加的回扣年化，一些將來自為 2024 年平價准入而協商的回扣增加。鑑於今年年中生物仿製藥的上市，尤其是那些奉行低效策略的生物仿製藥，我預計 24 年銷量將出現更多下滑。我們仔細研究了共識估計，分析師的估計範圍非常廣泛，最低估計和最高估計方法之間的差異為 40 億美元。

However, I'd say the average of those estimates appears to be a reasonable expectation for next year. Obviously, we'll give formal guidance likely on the Q4 call, which is our customary practice. But if you look at the average of those estimates, it should give you a good sense.

然而，我想說，這些估計的平均值似乎是明年的合理預期。顯然，我們可能會在第四季度電話會議上提供正式指導，這是我們的慣例。但如果你看看這些估計的平均值，你應該會有一個很好的感覺。

Thanks, Chris. Operator? No, sorry.

謝謝，克里斯。操作員？不，抱歉。

Yes. And then I'll take -- this is Rob on to your question on Skyrizi. So of the $200 million, it's split evenly between psoriatic $100 million and IBD a $100 million -- so that $7.6 billion psoriatics, about $6.7 million and IBD is around $900 million.

是的。然後我會回答你關於 Skyrizi 的問題。因此，在這 2 億美元中，銀屑病患者 1 億美元和 IBD 患者 1 億美元各平分 — 這樣，銀屑病患者 76 億美元，大約 670 萬美元，IBD 大約 9 億美元。

Operator, next question, please.

接線員，請下一個問題。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Congrats on the quarter. One clarification question and then one question. So clarification. So Rick, you mentioned that you think, like, again, at this point, you're not talking about increasing the floor, but you feel comfortable about the floor EPS range of $10.70. Is that fair, be it in 2023 or '24, that's the first clarification question. And then second one is, when we talk to investors, they do feel comfortable about the ex-Humira portfolio. But one question that cuts up all the time is that, I mean, the lack of shiny object or pipeline beyond Skyrizi and Rinvoq. To the extent you agree with that assessment, how do you plan to mitigate that? Or is there anything in the pipeline that investors are missing at this point?

恭喜本季度。一個澄清問題，然後一個問題。所以澄清一下。 Rick，你提到你認為，在這一點上，你並不是在談論增加下限，但你對 10.70 美元的下限 EPS 範圍感到滿意。無論是 2023 年還是 24 年，這公平嗎？這是第一個需要澄清的問題。第二個問題是，當我們與投資者交談時，他們確實對前 Humira 投資組合感到滿意。但我的意思是，有一個一直存在的問題是，除了 Skyrizi 和 Rinvoq 之外，缺乏閃亮的物體或管道。如果您同意該評估，您計劃如何緩解這種情況？或者目前投資者還缺少什麼？

Okay. This is Rick. So as far as the $10.70, I would tell you that we feel highly confident in the $10.70. So there shouldn't be any concern there. And as I said, with how the growth platform is performing, we would expect to update at some point the floor. And obviously, by the way I'm saying it, the update would be in an upward direction. So hopefully, that gives some clarity around the floor. .

好的。這是瑞克。因此，就 10.70 美元而言，我會告訴您，我們對 10.70 美元非常有信心。所以那裡不應該有任何擔心。正如我所說，根據增長平台的表現，我們預計會在某個時候更新樓層。顯然，順便說一句，更新將是向上的。希望這能讓大家更加清楚。 。

I think when you think about the pipeline, what I tell you about the way we operate is we design our investment in R&D to be able to deliver the kind of growth that we expect for the business over the long term, both short term and the long term. Our expectations of the business haven't changed. Our expectations are to build a strategy that allows this business to grow at the top tier and be able to do it over the long term and do it in a consistent way. And I'd say, as I look at our historical performance, we've obviously delivered on that. But as I look at forward-looking performance through the end of this decade and into the early part of the 30s, we're highly confident we can deliver high single-digit growth with the pipeline that we have now, and ultimately, with the assets that we have in the marketplace and how they're performing in the marketplace and their ability to be able to drive significant growth.

我認為，當您考慮管道時，我告訴您我們的運營方式是，我們設計研發投資，以便能夠實現我們對業務長期（短期和長期）預期的增長。長期。我們對業務的期望沒有改變。我們的期望是製定一項戰略，使該業務能夠在頂級發展，並能夠長期持續地發展。我想說，當我回顧我們的歷史表現時，我們顯然已經實現了這一目標。但當我展望本世紀末和 30 年代初期的前瞻性業績時，我們非常有信心能夠利用我們現在擁有的管道實現高個位數增長，並最終通過我們在市場上擁有的資產以及它們在市場上的表現以及它們推動顯著增長的能力。

And you see that in the performance that we're delivering now. If you look at the growth -- platform's growth in first quarter, and then look at it in the second quarter, it's accelerating at a very good pace, and it will continue to accelerate as we go through the rest of this year. And that once we get to a stable tail relatively stable tail on Humira will be that growth that emerges to be able to drive the company, and that's what gives us such a high level of confidence. But I think when you look at our pipeline, Certainly, we invested significantly in Skyrizi and Rinvoq, and that investment is paying off extremely well. We have a number of assets in our pipeline that will continue to help accelerate that growth as we move forward. So venetoclax for t(1114) and MDS are in samples of that.

您可以從我們現在提供的性能中看到這一點。如果你看看第一季度平台的增長，然後再看看第二季度的增長，你會發現它正在以非常好的速度加速，並且在今年剩下的時間裡它將繼續加速。一旦我們達到穩定的尾部，修美樂相對穩定的尾部將成為能夠推動公司增長的因素，這給了我們如此高的信心。但我認為，當你看看我們的管道時，當然，我們在 Skyrizi 和 Rinvoq 上投入了大量資金，而且這些投資得到了非常好的回報。我們擁有大量資產，這些資產將在我們前進的過程中繼續幫助加速增長。因此 t(1114) 的 Venetoclax 和 MDS 都在其中的樣本中。

ABBV-951, we should do any submission and get that product on the marketplace.

ABBV-951，我們應該進行任何提交並將該產品推向市場。

This a huge need for that product in the marketplace. And a number of other assets, I won't go through every one of them. the rest of our investment in R&D has really been focusing on assets that are designed to be able to sustain our growth from 2030 forward. And so as I look at our pipeline, and I know you don't have as much visibility as we do [it on other our] pipeline for things like the ABBY-400 platform and the cement platform that we have, the data we're seeing in CRC, non-small cell, that's a significant opportunity for us or is another significant opportunity for us.

市場對該產品的巨大需求。還有許多其他資產，我不會逐一介紹。我們在研發方面的其餘投資實際上一直集中在旨在能夠維持 2030 年以後增長的資產上。因此，當我查看我們的管道時，我知道您對我們擁有的 ABBY-400 平台和水泥平台等管道以及我們的數據的了解不如我們[在其他]管道上那樣多。在 CRC（非小基站）領域，這對我們來說是一個重要的機會，或者說是另一個對我們來說重要的機會。

Our neuroscience portfolio is ABBV-916 and other assets is another significant opportunity for us that will emerge in that time frame. We have a next-generation BTK degrader that we're excited about. We have a second-generation BCL-2 that we're very interested in pursuing in multiple myeloma. And so there's a number of assets here that just haven't emerged to the point that you have clear visibility on all that data, but we do have visibility to where they're progressing. And so I think it's just hard for you to assess that earlier pipeline, but it's really designed to deliver on that long-term growth. So we're confident between now and the early 30s. And as that pipeline matures and the data comes out, is another good example of where we have a lot of data now that is demonstrating that is probably best in class for a bispecific in myeloma. And so as that data emerges, you're going to get more visibility to it. And then obviously, we have the ability to go out and acquire things and we find things that we're interested in.

我們的神經科學投資組合是 ABBV-916，其他資產是我們在這段時間內出現的另一個重要機會。我們擁有令我們興奮的下一代 BTK 降解器。我們有第二代 BCL-2，我們對治療多發性骨髓瘤非常感興趣。因此，這裡有許多資產還沒有出現，以至於您可以清楚地了解所有這些數據，但我們確實可以了解它們的進展情況。所以我認為你很難評估早期的管道，但它確實是為了實現長期增長而設計的。所以我們對現在到 30 歲出頭充滿信心。隨著該管道的成熟和數據的出現，這是另一個很好的例子，我們現在擁有大量數據，這些數據證明這可能是骨髓瘤雙特異性藥物中最好的。因此，當這些數據出現時，您將獲得更多的可見性。顯然，我們有能力出去獲取東西，並且找到我們感興趣的東西。

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

好的。謝謝你，莫希特。接線員，請下一個問題。

Terence Flynn, Morgan Stanley.

特倫斯·弗林，摩根士丹利。

Maybe a couple for me. maybe Rick, just to follow-up on that last comment, maybe just an update on your M&A BD appetite here, particularly assets that can contribute more near term to growth? And then again, I want to see what you guys are hearing out there regarding the long-acting Botox competitor. It sounds like you're seeing stable market share, but any feedback on that product?

也許對我來說有幾個。也許 Rick，只是為了跟進最後的評論，也許只是介紹一下您的併購 BD 興趣的最新情況，特別是可以在短期內為增長做出更多貢獻的資產？再說一遍，我想看看你們對長效肉毒桿菌競爭對手的看法。聽起來您看到了穩定的市場份額，但是對該產品有任何反饋嗎？

Okay. So M&A, I mean, obviously, we have a very active group who's constantly working in the area of business development. We're primarily focused in the areas that we operate in franchises. So think of things like immunology, neuroscience, certain areas of neuroscience, oncology, aesthetics, as an example, we constantly look at and then eye care would be, I would say, the key areas of focus. As I said before, we don't need anything to be able to drive that high single digits. Obviously, if we can grow even faster, that's a good thing. I think all of us recognize that.

好的。所以，併購，我的意思是，顯然，我們有一個非常活躍的團隊，他們一直致力於業務發展領域。我們主要關注我們特許經營的領域。因此，以免疫學、神經科學、神經科學的某些領域、腫瘤學、美學為例，我們不斷地關注，然後我想說，眼睛護理將是重點關注的領域。正如我之前所說，我們不需要任何東西就能驅動如此高的個位數。顯然，如果我們能夠增長得更快，那是一件好事。我想我們所有人都認識到這一點。

If we find assets that are out there that are later-stage assets, and they fit our strategy and they fit the kind of target product profile that we would expect because we only look for assets that can significantly change standard of care. That's what we're good at. And so we evaluate lots of things, but many of them don't meet that threshold that we're looking for. But if we find something, we would obviously pursue it. If it was in an area that we thought we could maximize the value of it. And so, we'll continue to do that. So like I said, I feel good about where we are and what we can drive, and I feel good about how we're looking at assets that are in the outside. We certainly have the financial wherewithal to be able to acquire assets that are out there. And as we've mentioned before, we obviously acquire larger assets. And so we continue to look at those. But they have to meet our criteria and they have to be able to deliver a good return to the business. On DAXI, I feel very good about how the team -- Harry and the team are performing against that. But I'll let Carrie actually describe to you how it looks.

如果我們發現現有的資產是後期資產，並且它們符合我們的戰略，並且符合我們期望的目標產品概況，因為我們只尋找可以顯著改變護理標準的資產。這就是我們所擅長的。因此，我們評估了很多事情，但其中許多都沒有達到我們正在尋找的閾值。但如果我們發現了什麼，我們顯然會去追求它。如果它位於我們認為可以最大化其價值的領域。因此，我們將繼續這樣做。所以就像我說的，我對我們所處的位置以及我們可以推動的東西感到滿意，並且我對我們如何看待外部資產感到滿意。我們當然有足夠的財力來收購現有的資產。正如我們之前提到的，我們顯然收購了更大的資產。所以我們繼續關注這些。但他們必須符合我們的標準，並且必須能夠為業務帶來良好的回報。在 DAXI 上，我對 ​​Harry 和團隊的表現感到非常滿意。但我會讓嘉莉實際向你描述它的樣子。

Thanks, Rick. So in terms of DAXI, it's been more than 6 months since their launch and the uptake has been quite limited from our perspective in the low single digits.

謝謝，瑞克。因此，就 DAXI 而言，自推出以來已經過去 6 個多月了，從我們的角度來看，其使用量非常有限，只有低個位數。

So for context, as we benchmark our competitive launches. And you would benchmark this launch versus the most recent toxin to enter the U.S. market you would see it's tracking to about 25% of where another product would be at the same point in its launch. And in terms of customer feedback, we continue to hear that expectations are just not being met on duration, that expectations on the customer side and on the consumer side. So we have yet to see impact on Botox share and Botox will continue to be the clear market leader as the other toxins compete for the #2, 3, 4 position in our customers' offices. We are very pleased with the team's ability to execute on these competitive strategies here. And actually, their clear focus not only on the competitive strategies, but also on the broader focus and vision to grow the entire toxin market in the U.S., which we continue to see as biggest opportunity now and in the future.

因此，就背景而言，我們對我們的競爭產品進行了基準測試。如果您將這次發布的產品與最近進入美國市場的毒素進行基準比較，您會發現它的跟踪速度約為其他產品在同一時間發佈時的水平的 25%。在客戶反饋方面，我們不斷聽到客戶和消費者的期望在持續時間內沒有得到滿足。因此，我們尚未看到對 Botox 份額的影響，隨著其他毒素在我們客戶辦公室爭奪第二、第三、第四的位置，Botox 將繼續成為明顯的市場領導者。我們對團隊執行這些競爭策略的能力感到非常滿意。事實上，他們不僅明確關注競爭戰略，而且還關注發展美國整個毒素市場的更廣泛的關注和願景，我們仍然認為這是現在和未來的最大機遇。

Thank you, Carrie. Operator, next question, please.

謝謝你，嘉莉。接線員，請下一個問題。

Evan Seigerman, BMO.

埃文·西格曼，BMO。

I wanted to just talk about kind of how you think about market share across the growth portfolio, specifically Skyrizi and Rinvoq kind of going forward. Is there a potential ceiling for them in [one] market share you can realize in these markets? Or maybe comment on some of the gating factors for market share growth in each of the patient provider or reimbursement agreements.

我想談談您如何看待整個增長投資組合的市場份額，特別是 Skyrizi 和 Rinvoq 的未來發展。您在這些市場中可以實現的[一個]市場份額是否存在潛在上限？或者可以評論每個患者提供者或報銷協議中市場份額增長的一些限制因素。

Yes. Evan, it's Jeff. I'll take that one. One of the aspects that we have that I highlight and we look very carefully at, we look at both sort of in-play capture which I often refer to, for example, right now, the in-play capture for Skyrizi in psoriasis is about 50%. So we're capturing one out of every 2 patients. And our market share is about 32%, as I highlighted. So theoretically, as we study these markets that if there's not major innovation or major disruption that comes in place. And we really don't see that in psoriasis. You get such a high level of efficacy with Skyrizi, your market share, so the 32% starts to ramp up over time towards your in-play capture because you get the persistency effects and the fall off that take place in the market. So really, when you look at that, I could say the same thing, for example, with Rinvoq.

是的。埃文，是傑夫。我會接受那個。我強調並非常仔細地觀察的一個方面是，我們觀察了我經常提到的兩種遊戲中捕捉，例如，現在，牛皮癬中 Skyrizi 的遊戲中捕捉是關於50%。因此，我們捕獲了二分之一的患者。正如我所強調的，我們的市場份額約為 32%。因此，從理論上講，當我們研究這些市場時，如果沒有出現重大創新或重大顛覆。我們在牛皮癬中確實沒有看到這一點。你通過 Skyrizi 獲得瞭如此高水平的功效，你的市場份額，因此隨著時間的推移，32% 開始向你的遊戲中捕獲增加，因為你得到了市場上發生的持久性效應和下降。所以說真的，當你看到這一點時，我可以對 Rinvoq 說同樣的話。

I mentioned that it's capturing 25% of second line plus in-play share. It has like a 3% market share. So in terms of the ability to sort of grow that market share over time, we really monitor that capture rate in the early years, and then you just sort of -- the in place sort of pulls up your market share over time. So that's why we're quite encouraged at the speed of the ramps that we're seeing there and the ability to move that market share. Now when we study the models, you don't fully get there because typically, something else launches, time goes by. But we can feel very, very encouraged as we look at our in-play momentum that the market share starts to approach that over our long-range planning cycle.

我提到過它佔據了二線市場份額的 25%。它的市場份額約為 3%。因此，就隨著時間的推移增加市場份額的能力而言，我們在最初幾年確實監控了捕獲率，然後隨著時間的推移，就地拉動了您的市場份額。因此，這就是為什麼我們對我們所看到的增長速度和移動市場份額的能力感到非常鼓舞。現在，當我們研究模型時，你並沒有完全到達那裡，因為通常情況下，其他東西會啟動，時間會流逝。但當我們看到我們的實際勢頭時，我們會感到非常非常鼓舞，因為市場份額在我們的長期規劃週期中開始接近這一目標。

The only other thing I would add, this is Rick, is with Otezla head-to-head. I would say currently, Skyrizi is not competing much against Otezla, which is a pretty sizable opportunity. And we're very pleased with this head-to-head data. So that will open up another pool of patients that today Skyrizi doesn't necessarily compete against. So that data will obviously allow us to be able to position it quite effectively against Otezla.

我要補充的唯一一件事是，我是瑞克，他正在與奧特茲拉進行正面交鋒。我想說，目前 Skyrizi 與 Otezla 的競爭並不激烈，這是一個相當大的機會。我們對這些面對面的數據非常滿意。因此，這將開闢另一個今天 Skyrizi 不一定能與之競爭的患者群體。因此，這些數據顯然將使我們能夠非常有效地對抗 Otezla。

All right. Thank you, Chris. Operator, next question, please.

好的。謝謝你，克里斯。接線員，請下一個問題。

Chris Raymond, Piper Sandler.

克里斯·雷蒙德，派珀·桑德勒。

Just maybe a pipeline line of questioning here. Rick, I heard you mention maybe ABBV-951, but it wasn't in your prepared comments. Maybe -- I know you guys were saying you're working to respond to the CRL later this year with PDUFA in the first half. Is that still the case. And then maybe also on the pipeline. A couple of quarters ago, I think you guys talked about an interesting combo opportunity in IBD with that GLP-2 in-licensed, I think, from Scripps. Any updated thoughts here with this sort of mechanism as a combo agent?

也許這裡只是一條提問的管道。 Rick，我聽說你可能提到了 ABBV-951，但它不在你準備好的評論中。也許——我知道你們說你們正在努力在今年下半年通過 PDUFA 來回應 CRL。現在還是這樣嗎。然後也許也在醞釀之中。幾個季度前，我想你們談論了 IBD 中一個有趣的組合機會，我認為 GLP-2 是從 Scripps 獲得許可的。對於這種機製作為組合代理，有什麼更新的想法嗎？

It's Roopal. I can take those. So for ABBV-951, the team is still on track for a resubmission this year, consistent with what you just stated. And in fact, we've launched in Japan, and there's already commercial patients receiving it. So the team is very excited about that. And what was described earlier. The unmet need is still quite high, and we still believe in a very strong profile in that asset. Along the lines of combinations, as you mentioned, on GLP-2, we feel with -- something like Skyrizi, the data that we've seen in Crohn's and ulcerative colitis there's still potentially an opportunity to even increase endoscopic or mucosal healing even higher. We're seeing high ranges already 50%, 60%. But we can still potentially go higher and something like a GLP-2 can directly address mucosal healing.

是魯帕爾。我可以接受那些。因此，對於 ABBV-951，該團隊今年仍有望重新提交，與您剛才所說的一致。事實上，我們已經在日本推出，並且已經有商業患者接受它。所以團隊對此感到非常興奮。以及前面所描述的內容。未滿足的需求仍然相當高，我們仍然相信該資產的前景非常強勁。正如您提到的，在 GLP-2 上，沿著組合的思路，我們覺得像 Skyrizi 一樣，我們在克羅恩病和潰瘍性結腸炎中看到的數據仍然有可能進一步提高內窺鏡或粘膜的癒合速度。 。我們看到的高範圍已經達到了 50%、60%。但我們仍然可以走得更高，像 GLP-2 這樣的東西可以直接解決粘膜癒合問題。

So that could be a potential combo. There's other assets in our immunology pipeline that we are also considering for a combination. But when you have an asset like Skyrizi and the safety profile that we continue to observe that creates, I would say, multiple opportunities.

所以這可能是一個潛在的組合。我們的免疫學管道中還有其他資產，我們也在考慮進行組合。但是，當你擁有像 Skyrizi 這樣的資產以及我們持續觀察到的安全狀況時，我想說，這會創造多個機會。

If I can just add, we didn't really opt in yet. Our collaboration with Caliber, which we expanded this week to more programs includes them doing a Phase Ia study which is almost finished. We're going to see the data and make that decision. It does fall into our -- part of our immunology program, which is in epithelial repair, which Roopal just mentioned. And so this is one of the assets which we think if you get a healthier gut to prepare that there will be in combination with immunomodulators will get a better response over time. We have another program called RIPK1, which also is involved in epithelial repair. So as multiple strategies, but this is one where we'll be making a decision and announcing a later time this year.

如果我可以補充一下，我們還沒有真正選擇加入。我們與 Calibre 的合作本週擴展到更多項目，其中包括他們正在進行一項即將完成的 Ia 期研究。我們將查看數據並做出決定。它確實屬於我們免疫學計劃的一部分，即上皮修復，魯帕爾剛才提到了這一點。因此，這是我們認為的資產之一，如果你有一個更健康的腸道，與免疫調節劑結合使用，隨著時間的推移會得到更好的反應。我們還有另一個名為 RIPK1 的程序，它也參與上皮修復。因此，作為多種策略，但這是我們將在今年晚些時候做出決定並宣布的策略。

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

謝謝你，克里斯。接線員，請下一個問題。

Steve Scala, TD Cowen.

史蒂夫·斯卡拉，TD·考恩。

A couple of questions. This morning, Takeda noted weakness in the U.S. GI market, and it seemed to be mainly on patient levels as opposed to competition. Wondering if you're seeing this and to what do you attribute it? So that's the first question. On the second question, on the Q1 call, the company said it would narrow the EPS range when it had clarity on biosimilar Humira and the landscape for that. .

有幾個問題。今天早上，武田注意到美國地理標誌市場的疲軟，這似乎主要是在患者層面，而不是競爭層面。想知道您是否看到了這一點以及您將其歸因於什麼？這是第一個問題。關於第二個問題，在第一季度的電話會議上，該公司表示，當生物仿製藥 Humira 及其前景變得清晰時，它將縮小每股收益範圍。 。

So you narrowed that range today despite most biosimilars having been on the market for only 3 weeks, what do you know now that you didn't know when you reported in April that gives you the confidence to narrow the range today or is it all about the performance of the rest of the portfolio and really not about Humira?

因此，儘管大多數生物仿製藥上市僅 3 週，但您今天縮小了該範圍，您現在知道什麼是您在 4 月份報告時所不知道的，這讓您有信心今天縮小範圍，或者這一切都是關於投資組合其餘部分的表現真的與 Humira 無關嗎？

Steve, it's Jeff. No, we don't see any slowdown in the IBD market. I mean this market has been just one of the highest growth markets we've seen from a CAGR perspective over many, many years. There's such unmet need. And so no, we're not seeing any patient slowdown. I would say, look, if we look at our particular data, I mean, you're seeing very fast ramps on this in-place share from Skyrizi and Crohn's disease. .

史蒂夫，我是傑夫。不，我們沒有看到 IBD 市場出現任何放緩。我的意思是，從多年來複合年增長率的角度來看，這個市場一直是我們看到的增長最快的市場之一。有這樣未滿足的需求。所以不，我們沒有看到任何病人的放緩。我想說，如果我們看一下我們的特定數據，我的意思是，您會看到 Skyrizi 和克羅恩病的就地份額增長非常快。 。

Now you're seeing an equally fast ramp in the early weeks from Rinvoq and Crohn's disease. And again, we're capturing up to 25% of the second line plus patients in ulcerative colitis. So I don't know what data Takeda is looking at, but we're seeing that the competitors in that space. And the leading competitors are Stelara and Entyvio and of course, our own Humira, but it's Stelara and Entyvio, they're under pressure in terms of incremental patient capture since our launch, and we'll continue to monitor. But we don't see any patient flow issues in the marketplace.

現在，您會看到 Rinvoq 和克羅恩病在最初幾週內同樣快速增長。再次，我們捕獲了多達 25% 的二線及以上潰瘍性結腸炎患者。所以我不知道武田正在查看哪些數據，但我們看到了該領域的競爭對手。主要競爭對手是 Stelara 和 Entyvio，當然還有我們自己的 Humira，但自我們推出以來，他們在增加患者捕獲量方面面臨壓力，我們將繼續監控。但我們在市場上沒有看到任何患者流動問題。

And Steve, this is Rob. On your second question. I think it's a combination of both. We're seeing very strong performance from the ex-Humira growth platform, as you can see by the guidance raise, that's really a contributor. But now that we're beyond the middle of the year. We know the biosimilars that have entered the market, we know they're facing prices. We've maintained strong parity access. And so that also increased our confidence which is why we've narrowed the range to $0.20. But it's a combination of both the ex-Humira growth platform performing very strongly as well as where we sit today with biosimilar competition for Humira.

史蒂夫，這是羅布。關於你的第二個問題。我認為這是兩者的結合。我們看到前 Humira 增長平台的表現非常強勁，正如您從指導性提高中看到的那樣，這確實是一個貢獻者。但現在已經過了年中了。我們知道已經進入市場的生物仿製藥，我們知道它們面臨著價格上漲的問題。我們一直保持強大的平價訪問。這也增強了我們的信心，這也是我們將範圍縮小至 0.20 美元的原因。但這是前 Humira 增長平台表現非常強勁以及我們今天面臨的 Humira 生物仿製藥競爭的結合。

Thanks, Steve. Operator, next question, please.

謝謝，史蒂夫。接線員，請下一個問題。

Carter Gould, Barclays.

卡特·古爾德，巴克萊銀行。

I guess, two, acknowledging all your comments on the pipeline and previous comments on BD. Rick, was looking to get your thoughts on how the more assertive FTC here is limiting your target list on BD or your ability to complete deals? And then maybe just on Botox. Just was hoping for a little bit more color on the sustainability of the ex-U.S. trends versus maybe some of that demand getting pushed into the quarter after some of the shutdowns, COVID impacts and whatnot ex-U.S.

我想，有兩個，感謝您對管道的所有評論以及之前對 BD 的評論。 Rick，想了解您對這裡更加自信的 FTC 如何限制您在 BD 上的目標清單或您完成交易的能力有何看法？然後也許只需要注射肉毒桿菌即可。只是希望對前美國的可持續性有更多的了解。相比之下，在一些停工、新冠疫情影響以及美國以外地區的影響之後，部分需求可能會被推到本季度。

Okay. So I'll take the first question. Obviously, the FTC appears to be applying a lot more scrutiny to transactions. Having said that, I would say even before this happened, we would always evaluate an acquisition of a product or a company in the backdrop of what we thought the competitive environment would be our position in that market, meaning we didn't necessarily go out and try to do transactions that we thought would be extremely difficult from an FTC standpoint. .

好的。那麼我來回答第一個問題。顯然，聯邦貿易委員會似乎正在對交易進行更多審查。話雖如此，我想說，即使在這種情況發生之前，我們總是會在我們認為競爭環境將是我們在該市場中的地位的背景下評估對產品或公司的收購，這意味著我們不一定會走出去並嘗試進行我們認為從聯邦貿易委員會角度來看極其困難的交易。 。

So I think the way we think about the FTC situation now is, look, it may require more time to get acquisitions through it may even require that you're willing to pursue litigation in order to get those through. But in the end, if your position is that what you're trying to do is not anticompetitive. You will be able to ultimately prevail in that process. And I think we're seeing that as some of these transactions go to court. Some not in our own industry, but in other industries, I think that's playing out. And so I think ultimately, it will end up being more of a delay, but not something that staples your ability to do things that are appropriate to do. That's my perspective on it. Carrie?

所以我認為我們現在考慮聯邦貿易委員會情況的方式是，看，它可能需要更多時間來完成收購，甚至可能需要你願意提起訴訟才能完成這些收購。但最終，如果你的立場是你想做的事情並不反競爭。你將能夠最終在這個過程中獲勝。我認為隨著其中一些交易告上法庭，我們正在看到這一點。有些不是在我們自己的行業，而是在其他行業，我認為這正在發揮作用。所以我認為最終，這將更多地是一種延遲，但不會增強你做適當事情的能力。這就是我的看法。嘉莉？

Sure. In terms of the aesthetics market internationally, like we said, we've been very pleased with the performance so far, and we expect to -- we continue to expect to see that type of strong performance through the rest of the year. We're continuing to invest in key growth markets like Japan and in markets like Brazil. And of course, China has become our second biggest market globally. And in China, in the first quarter, we did see significant growth as the market was reopening from COVID and some pent-up demand that came through in Q1 and early Q2.

當然。就國際美容市場而言，正如我們所說，我們對迄今為止的表現非常滿意，並且我們預計 - 我們繼續期望在今年剩餘時間內看到這種強勁的表現。我們將繼續投資日本等主要增長市場和巴西等市場。當然，中國已經成為我們的全球第二大市場。在中國，第一季度，隨著市場從新冠疫情中重新開放，以及第一季度和第二季度初出現的一些被壓抑的需求，我們確實看到了顯著增長。

And now China has returned to normalized high growth rates. And so despite some economic pressures there, we really continue to see strong growth as we continue to invest and expand our promotional footprint there through field force, through injector training and our consumer efforts. And China will continue to be a really attractive market for us. Based on that commercial expansion and also, we're going to have a steady flow of new product launches throughout the decade in that market. One thing to note, which we did mention in our prepared remarks is that we do expect Q3 to be relatively flat internationally based on shipment timing from last year with that return to growth in Q4 and high single-digit growth for the full year internationally.

現在中國已經恢復正常的高增長率。因此，儘管那裡存在一些經濟壓力，但隨著我們繼續投資並通過現場人員、注射器培訓和消費者努力擴大我們的促銷足跡，我們確實繼續看到強勁的增長。中國將繼續成為對我們來說非常有吸引力的市場。基於這種商業擴張，我們將在十年內在該市場上穩定地推出新產品。需要注意的一件事是，我們在準備好的發言中確實提到了這一點，我們確實預計，根據去年的出貨時間，第三季度國際市場將相對持平，第四季度將恢復增長，全年國際市場將實現高個位數增長。

And then, Carter, you were specifically asking about international Botox. I think if you just look at the run rate through the 6 months of the year, that's probably a good proxy for where we expect international Botox to land. We're holding strong share positions. [Force] is very, very good. So there's really no dynamic there. As Carrie mentioned, I mean you have to keep in mind that fillers a very large market for us, business for us internationally. We do have the Q3 dynamic. But when you look at the full year for international, that high single-digit growth, is certainly a way to think about the international business for aesthetics.

然後，卡特，您專門詢問了國際肉毒桿菌素。我認為，如果你只看一年中 6 個月的運行率，這可能是我們預期國際肉毒桿菌毒素落地的一個很好的指標。我們持有強勁的股票頭寸。 【力】非常非常好。所以那裡真的沒有動力。正如嘉莉提到的，我的意思是你必須記住，這為我們填補了一個非常大的市場，為我們提供了國際業務。我們確實有第三季度的動態。但當你審視全年的國際業務時，你會發現這種高單位數增長無疑是思考國際美學業務的一種方式。

Thanks, Carter. Operator, next question, please.

謝謝，卡特。接線員，請下一個問題。

David Risinger, Leerink Partners.

大衛·瑞辛格 (David Risinger)，Leerink 合夥人。

Yes. So I have two questions. Rick, you had mentioned that you're expecting stabilization of Humira sales at some point. Could you provide some perspective on when you might expect that? And then second, with respect to the Filler franchise, obviously, it's performing strongly, could you discuss the prospects including the driver of weight loss drug patients seeking to compensate for facial hallowing?

是的。所以我有兩個問題。里克（Rick），您曾提到您預計修美樂（Humira）的銷售將在某個時候趨於穩定。您能否就您預計何時會出現這種情況提供一些看法？其次，關於 Filler 專營權，顯然它表現強勁，您能否討論一下前景，包括尋求補償面部空洞的減肥藥物患者的司機？

On the Humira tail, as Rob mentioned earlier, obviously, you have the annualization of the impact that we have this year, the second half annualization that's going to roll into '24. We're going to have further price erosion in '24, both based on the contracts that we have and how we're expecting the market to play out. And I'd say the pricing in the marketplace has been consistent with what our original assumptions were. .

在 Humira 尾部，正如 Rob 之前提到的，顯然，你有今年影響的年化，下半年年化將進入 24 年。根據我們現有的合同以及我們對市場走勢的預期，我們將在 24 年進一步降低價格。我想說市場上的定價與我們最初的假設是一致的。 。

So I think the expectation you'll start to see stabilization of that tail in '25. And benefit operates similar to what we see in the international markets, which I think would probably be low at that point. it becomes relatively stable, I'd say, in '26 going forward. And it should be still a substantial tail that we maintain. But see less erosion pressure on it at that point. Carrie, do you want to talk a little bit about the Otezla impact?

所以我認為你會在 25 年開始看到尾巴的穩定。效益的運作與我們在國際市場上看到的類似，我認為屆時可能會很低。我想說，26 年以後它會變得相對穩定。它應該仍然是我們維持的一個實質性的尾巴。但此時看到的侵蝕壓力較小。 Carrie，你想談談 Otezla 的影響嗎？

Sure. So in terms of the Filler opportunity and outlook, I guess, it was that big -- I'll start -- I'll zoom out a little bit and just comment on that the Filler market continues to be really attractive, especially internationally, as you've already seen here right now. with China driving some strong growth.

當然。因此，就填充劑機會和前景而言，我想，它就那麼大——我將開始——我將縮小一點，只是評論填充劑市場仍然非常有吸引力，尤其是在國際上，正如您現在已經在這裡看到的那樣。中國推動了一些強勁的增長。

And really some of the key Juvederm brand have just become available in China in the past few years, and we'll continue to have, like I said, a cadence of Juvederm launches in China. And then our increased investment all over the world and continues to drive our Filler business and gives us a lot of optimism there internationally.

事實上，喬雅登的一些主要品牌在過去幾年剛剛在中國上市，正如我所說，我們將繼續在中國推出喬雅登產品。然後我們在世界各地增加了投資，並繼續推動我們的填料業務，並給我們帶來了國際上的很多樂觀情緒。

Now in the U.S., we have said that the inflationary dynamics have impacted the U.S. market for Filler and more than toxin just by the nature of the Filler pricing and procedure. And also in terms of the patient journey patients tend to start on toxin before they add Filler. And so for all those reasons, we believe that the top -- the Filler market will continue to improve in the second half of the year. although it will lag the toxin market recovery a bit.

現在在美國，我們已經說過，通貨膨脹動態對美國填充劑和毒素市場的影響不僅僅是填充劑定價和程序的性質。而且就患者旅程而言，患者往往在添加填充劑之前就開始使用毒素。因此，出於所有這些原因，我們相信頂級填料市場將在今年下半年繼續改善。儘管它會稍微滯後於毒素市場的複蘇。

Now in terms of the question around Ozempic, we have been keeping an eye on that and how these weight loss products could have an impact on the aesthetics market. And what we see is that really anything that gets a consumer engaged in their appearance, including products like Ozempic are a positive tailwind for the aesthetics business.

現在，關於 Ozempic 的問題，我們一直在關注這個問題以及這些減肥產品如何對美容市場產生影響。我們看到的是，任何能讓消費者關注自己外表的東西，包括 Ozempic 這樣的產品，都是美容行業的積極推動力。

And we are hearing some customers say that this facial hollowing for fillers -- or for -- that's a result of these products is an opportunity for fillers. We see that on social media. We're tracking it in other forms of media. And we think that like many other consumer trends around aesthetics, this will just continue to be a tailwind and the positive dynamic of the business.

我們聽到一些顧客說，這些產品導致的面部凹陷對於填充劑來說是一個機會。我們在社交媒體上看到了這一點。我們正在通過其他形式的媒體對其進行追踪。我們認為，就像許多其他圍繞美學的消費趨勢一樣，這將繼續成為業務的順風和積極動力。

Thanks, David Risinger. Operator, next question, please.

謝謝，大衛·瑞辛格。接線員，請下一個問題。

Tim Anderson, Wolfe Research.

蒂姆·安德森，沃爾夫研究中心。

A couple of questions. How much uncertainty is there in terms of contracting in the I&I category in 2024 from a pricing standpoint for Skyrizi and Rinvoq. And when will you be able to provide an update on how those pricing discussions are going for those 2 brands. So not the formal sales guidance for those products, but how the pricing discussions are going. And what is your expectation today for that level of price erosion in 2024 relative to what it's been in 2023?

有幾個問題。從 Skyrizi 和 Rinvoq 的定價角度來看，2024 年 I&I 類別的合同存在多少不確定性。您什麼時候能夠提供有關這兩個品牌的定價討論進展情況的最新信息。因此，不是這些產品的正式銷售指南，而是定價討論的進展情況。您對 2024 年相對於 2023 年的價格下跌水平有何預期？

Okay. So I think Jeff and I will tag team this one. It's a great question because, look, I think we all know there has been some question out in the marketplace since the first quarter about I&I pricing. And so let me try to frame our perspective on the pricing because I think there's some misconception that's developed in the marketplace to some extent around I&I pricing. I guess the first thing I'd say to you, this is a market we know well. We've been in this market for a long time. We're obviously a leader in this market.

好的。所以我想傑夫和我會標記這個團隊。這是一個很好的問題，因為我想我們都知道自第一季度以來市場上就存在一些關於 I&I 定價的問題。因此，讓我嘗試闡述一下我們對定價的看法，因為我認為市場上在某種程度上對 I&I 定價存在一些誤解。我想我要對你說的第一件事是，這是一個我們非常了解的市場。我們已經進入這個市場很長時間了。我們顯然是這個市場的領導者。

So it's a market we know extremely well. And obviously, we know any trend that's occurring in this market to a high degree of detail. And what I would tell you is that we see no fundamental change in the way pricing is being dealt with in this marketplace nor do we expect to see any fundamental change that occurs in the foreseeable future. So that brings me to the rebate question in the first quarter.

所以這是一個我們非常了解的市場。顯然，我們非常詳細地了解這個市場中正在發生的任何趨勢。我要告訴你的是，我們認為這個市場的定價方式不會發生根本性的變化，也不希望看到在可預見的未來發生任何根本性的變化。這讓我想到了第一季度的回扣問題。

And I would tell you that we're operating exactly the same way we have historically operated in this segment as it relates to rebating or discounting. When we get a new indication or when we get a new product, one of the things that we evaluate is -- okay, what level of rebating should we do in order to maximize 2 things for the product. The speed at which we can drive the ramp and the ultimate peak sales that we can drive for that asset. We weigh those 2 things against how we look at contracting and getting on formulary. And so when you get an indication, you make a trade off.

我想告訴你，我們的運營方式與我們歷史上在該領域的運營方式完全相同，因為它涉及回扣或折扣。當我們得到一個新的適應症或當我們得到一個新產品時，我們評估的事情之一是——好吧，我們應該採取什麼水平的回扣才能最大限度地提高產品的兩件事。我們可以推動該資產的增長速度以及最終的峰值銷售。我們會根據我們如何看待簽約和加入處方集來權衡這兩件事。因此，當您得到指示時，您就會做出權衡。

Do I want to be on formulator? I don't. If I do, I have to provide some level of incremental rebates. Is that a financially positive decision for the asset in the company. And if it is, we make that decision. And I would say that Skyrizi and Rinvoq are classic examples of that strategy. And I would say, look at how they're performing. We're going to grow those 2 assets despite the increased rebates, $3.5 billion this year. And that's a pretty good trade-off. I don't know, Jeff, anything you'd add?

我想成為配方師嗎？我不。如果我這樣做，我必須提供一定程度的增量回扣。這對公司資產來說是一個財務上積極的決定嗎？如果是的話，我們就會做出決定。我想說 Skyrizi 和 Rinvoq 是該策略的典型例子。我想說，看看他們的表現如何。儘管今年回扣增加了 35 億美元，但我們仍將增加這兩項資產。這是一個非常好的權衡。我不知道，傑夫，你還有什麼要補充的嗎？

Yes. Maybe just to build on that point, Rick. I mean this fact base of 7 indications in one year in one category with one firm, it's just -- it's really unprecedented. It's not going to happen again. And I think it's important to think about how it works. I mean, when you get a new indication and they're sequencing over time, you've got to clear the payer's P&T clinical committee, and they don't meet every day.

是的。也許只是為了建立這一點，里克。我的意思是，一家公司一年內在一個類別中出現 7 個跡象的事實基礎，這確實是前所未有的。這種事不會再發生了。我認為思考它是如何運作的很重要。我的意思是，當你得到一個新的適應症並且他們隨著時間的推移進行測序時，你必須批准付款人的 P&T 臨床委員會，而他們不會每天開會。

They meet every couple of months. So there's a process there. And then you've got to be added to the formulary structure. So you either have to somehow gain a new spot by indication or replace a competitor. And that's not easy as well. And so that's why what we see in the marketplace. Many competitive firms have to offer these free or bridge programs and not just for a quarter or 2, sometimes there are multiple quarters or years until that access ramps.

他們每隔幾個月見面一次。所以那裡有一個過程。然後你必須添加到公式結構中。因此，你要么必須通過指示以某種方式獲得新的位置，要么取代競爭對手。這也並不容易。這就是我們在市場上看到的原因。許多有競爭力的公司必須提供這些免費或過渡計劃，而且不僅僅是一個季度或兩個季度，有時需要多個季度或幾年，直到訪問量增加。

And I would say, in contrast, Rick, as you noted, on average, we achieved fully paid access for those 7 indications in about 60 days, really, really unprecedented. So that means we had to give very little free goods we had almost immediate paid access and profit flow and then, of course, that rapid revenue accumulation that you highlighted. So definitely the right trade-off, and we don't see that recurring. .

我想說的是，相比之下，Rick，正如您所指出的，平均而言，我們在大約 60 天內實現了這 7 種適應症的完全付費訪問，這真的非常前所未有。因此，這意味著我們必須提供很少的免費商品，我們幾乎可以立即付費訪問和利潤流，當然，還有您強調的快速收入積累。所以這絕對是正確的權衡，而且我們沒有看到這種情況再次出現。 。

And Tim, on your second question, I mean we've said this before, the high single-digit price impact this year is a function, again, as Jeff mentioned, 7 new indications. We do not expect that type of price erosion going forward. It should not be what investors are modeling. So I wouldn't be concerned about high single-digit price erosion in '24.

蒂姆，關於你的第二個問題，我的意思是我們之前說過，今年高個位數的價格影響是一個函數，正如傑夫提到的，有 7 個新跡象。我們預計未來不會出現這種類型的價格侵蝕。這不應該是投資者所建模的。因此，我不會擔心 24 年高個位數的價格侵蝕。

Thanks, Tim. Operator, we have time for one final question.

謝謝，蒂姆。接線員，我們有時間回答最後一個問題。

And that will be from Geoff Meacham, Bank of America.

這將是美國銀行傑夫·米查姆 (Geoff Meacham) 的發言。

On OUS Humira, you're obviously well past the initial biosimilar way, but you're still seeing some sequential decline. So what's the context here? And is there a dynamic that could impact Skyrizi or Rinvoq even indirectly OUS?

對於 OUS Humira，您顯然已經遠遠超過了最初的生物仿製藥方式，但您仍然看到一些連續下降。那麼這裡的背景是什麼？是否有一種動態可能會影響 Skyrizi 或 Rinvoq，甚至間接影響 OUS？

And then on Navitoclax, I know you guys have more details to come, but is there a threshold you're looking for and TRANSFORM-1 to move forward or even to inform development in other indications, just thinking about maybe the tolerability profile and the comps in that?

然後關於 Navitoclax，我知道你們還有更多細節，但是你們正在尋找和 TRANSFORM-1 是否有一個閾值來向前推進，甚至為其他適應症的開發提供信息，只需考慮可能的耐受性概況和在那方面比較？

So Jeff, this is Rob. I'll answer your question on International Humira. If you look at the '23 erosions, Its's about $600 million it's really split in, I'd say, 3 buckets. About $300 million of it is new biosimilar markets, markets like Canada, Puerto Rico, Mexico. Those are -- remember, we have additional waves coming in. So that's the next wave coming in so about half of it is that. And then I characterize about $200 million being really the impact of new agents like Skyrizi and Rinvoq, right?

傑夫，這是羅布。我會回答你關於國際修美樂的問題。如果你看看 23 年的侵蝕，它大約是 6 億美元，我想說，它實際上被分成了 3 個桶。其中約 3 億美元來自新的生物仿製藥市場，如加拿大、波多黎各、墨西哥等市場。記住，我們還有更多的浪潮湧入。這就是下一波湧入的浪潮，所以大約有一半是這樣的。然後我認為大約 2 億美元實際上是像 Skyrizi 和 Rinvoq 這樣的新代理的影響，對吧？

So you have agents that deliver higher standard of care, and so you're going to see share erosion just through that dynamic. And fortunately, we've brought forward our own products that do that. And so I'd say of that $600 million, $200 million is roughly that. And then in the international markets, you typically see some, I'd say, low to mid-single-digit price erosion, just typically year-over-year.

因此，您擁有提供更高標準護理的代理，因此您將通過這種動態看到份額侵蝕。幸運的是，我們已經推出了自己的產品來做到這一點。所以我想說，6 億美元，大約就是 2 億美元。然後在國際市場上，我想說，你通常會看到一些低到中個位數的價格侵蝕，通常是逐年下降。

So that's about another $100 million. So it's important to characterize it the right way. It's not so much markets that were biosimilar several years ago. It's more recent biosimilar markets, our own competition from our own agents as well as the typical price erosion you see in the international market.

大約還有 1 億美元。因此，以正確的方式表徵它很重要。幾年前，生物仿製藥的市場並不多。這是最近的生物仿製藥市場、我們自己來自代理商的競爭以及您在國際市場上看到的典型價格侵蝕。

It's Roopal. I'll take the Navitoclax question. So we'll continue to monitor the spleen volume reduction and see how that looks towards the end of the year. And if it maintains the high level that Tom described, that's something that definitely a positive. The other things that we'll get that will reveal themselves over the longer term as the marrow fibrosis and that, along with the spleen volume reduction and actually some of our earlier data may be correlative for survival events.

是魯帕爾。我來回答納維托克的問題。因此，我們將繼續監測脾臟體積的減少情況，看看年底時的情況如何。如果它保持湯姆所描述的高水平，那絕對是積極的。我們將得到的其他信息將在長期內揭示出來，如骨髓纖維化，以及脾臟體積縮小，實際上我們早期的一些數據可能與生存事件相關。

So we'll get an early look at those. And then in terms of tolerability, what we've seen thus far is consistent with what we've seen initially, and it is a titratable dosing. So the clinicians can tailor in the study to what the patient needs. So more to come by year-end.

所以我們會儘早了解這些。然後就耐受性而言，到目前為止我們所看到的與我們最初所看到的一致，並且是可滴定劑量。因此，臨床醫生可以根據患者的需求定制研究。到年底還會有更多。

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

好的。謝謝，傑夫。今天的電話會議到此結束。如果您想收聽電話會議的重播，請訪問我們的網站 Investors.abbvie.com。再次感謝您加入我們。

As we are concluded. Again, thank you for your participation. You may please disconnect at this time.

正如我們得出的結論。再次感謝您的參與。此時您可以斷開連接。