艾伯維 (ABBV) 2021 Q4 法說會逐字稿

Good morning and thank you for standing by. Welcome to the AbbVie Fourth Quarter 2021 Earnings Conference Call. (Operator Instructions) I would now like to introduce Ms. Liz Shea, Vice President, Head of Investor Relations.

早上好，感謝您的支持。歡迎參加艾伯維 2021 年第四季度收益電話會議。 （操作員須知）我現在想介紹一下副總裁兼投資者關係主管 Liz Shea 女士。

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; Michael Severino, Vice Chairman and President; Rob Michael, Vice Chairman, Finance and Commercial Operations and Chief Financial Officer; and Jeff Stewart, Executive Vice President, Chief Commercial Officer. Joining us for the Q&A portion of the call is Laura Schumacher, Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary.

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； Michael Severino，副主席兼總裁； Rob Michael，財務和商業運營副主席兼首席財務官；和執行副總裁兼首席商務官 Jeff Stewart。與我們一起參加電話問答環節的是勞拉·舒馬赫（Laura Schumacher），她是對外事務副主席、首席法務官兼公司秘書。

Before we get started, some statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. 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 the forward-looking statements. Additional information about these risks and uncertainties is included in our SEC filings. AbbVie undertakes no obligation to update these forward-looking statements, except as required by law.

在我們開始之前，我們今天所做的一些陳述可能被視為 1995 年《私人證券訴訟改革法案》的前瞻性陳述。艾伯維警告說，這些前瞻性陳述受到可能導致實際結果不同的風險和不確定性的影響實質上來自前瞻性陳述中指出的內容。有關這些風險和不確定性的更多信息包含在我們提交給美國證券交易委員會的文件中。除非法律要求，否則 AbbVie 不承擔更新這些前瞻性陳述的義務。

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

在今天的電話會議上，非 GAAP 財務指標將用於幫助投資者了解 AbbVie 的業務表現。這些非公認會計原則財務指標與我們從今天開始的收益發布和監管文件中的可比公認會計原則財務指標相一致，可以在我們的網站上找到。

Unless otherwise noted, our commentary on sales growth is on a comparable basis, which includes full current year and historical results for Allergan. For this comparison of underlying performance, all historically reported Allergan revenues have been recast to conform to AbbVie's revenue recognition accounting policies and exclude the divestitures of Zenpep and Viokace. References to operational growth further excludes the impact of exchange. Following our prepared remarks, we'll take your questions.

除非另有說明，否則我們對銷售增長的評論是在可比基礎上進行的，其中包括艾爾建 (Allergan) 的全年業績和歷史業績。對於基本業績的這種比較，所有歷史報告的艾爾建（Allergan）收入都已重新計算，以符合艾伯維（AbbVie）的收入確認會計政策，不包括 Zenpep 和 Viokace 的剝離。對運營增長的提及進一步排除了交換的影響。在我們準備好的評論之後，我們將回答您的問題。

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

因此，我現在將電話轉給 Rick。

Thank you, Liz. Good morning, everyone, and thank you for joining us today. I'll provide perspective on our overall performance and outlook. And then Jeff, Mike and Rob will review our quarterly business highlights, pipeline progress, financial results and guidance for 2022 in more detail.

謝謝你，麗茲。大家早上好，感謝您今天加入我們。我將就我們的整體表現和前景發表看法。然後 Jeff、Mike 和 Rob 將更詳細地審查我們的季度業務亮點、管道進展、財務業績和 2022 年指導。

Our performance this quarter tops off another excellent year for AbbVie, with results well above our initial expectations. We delivered full year 2021 adjusted earnings per share of $12.70, representing growth of more than 20% versus the prior year. Full year adjusted net revenues were more than $56 billion, up 10.5% on a comparable operational basis. These results demonstrate balanced performance across each of our major growth franchises, including double-digit comparable operational revenue growth from immunology, aesthetics and neuroscience.

我們本季度的表現為艾伯維（AbbVie）又一個出色的一年畫上了句號，其結果遠高於我們最初的預期。我們實現了 2021 年全年調整後每股收益 12.70 美元，較上年增長 20% 以上。全年調整後淨收入超過 560 億美元，在可比運營基礎上增長 10.5%。這些結果證明了我們每個主要增長專營權的平衡表現，包括來自免疫學、美學和神經科學的兩位數可比運營收入增長。

I'm extremely pleased with our momentum, and we've entered this year in a strong position, which is reflected in our guidance. We anticipate 2022 adjusted earnings per share of $14 to $14.20, representing growth of 11% at the midpoint. Longer term, we remain well positioned with an impressive set of diversified growth assets.

我對我們的勢頭感到非常滿意，今年我們進入了強勢地位，這反映在我們的指導中。我們預計 2022 年調整後每股收益為 14 美元至 14.20 美元，中點增長 11%。從長遠來看，我們仍然擁有一系列令人印象深刻的多元化增長資產。

In immunology, Skyrizi and Rinvoq are already contributing meaningful revenue, including $4.6 billion in combined sales last year with substantial growth anticipated in 2022 and beyond. Over the next few months, we expect to add several new indications to the list of approved uses for these 2 assets. At which point, Skyrizi and Rinvoq will be commercialized across all of Humira's major indications plus atopic dermatitis. With the strong performance that we're seeing in their initial indications and the robust data we've demonstrated across our broad development programs, we expect combined peak sales for Skyrizi and Rinvoq to exceed the peak revenues achieved by Humira.

在免疫學領域，Skyrizi 和 Rinvoq 已經貢獻了可觀的收入，包括去年 46 億美元的合併銷售額，預計 2022 年及以後將出現大幅增長。在接下來的幾個月中，我們預計將在這兩項資產的批准用途列表中添加幾個新的適應症。屆時， Skyrizi 和 Rinvoq 將在 Humira 的所有主要適應症和特應性皮炎中實現商業化。憑藉我們在初步跡像中看到的強勁表現以及我們在廣泛的開發計劃中展示的強大數據，我們預計 Skyrizi 和 Rinvoq 的合併峰值銷售額將超過 Humira 實現的峰值收入。

In hematological oncology, we've established a leading position with Imbruvica and Venclexta, which are both expected to remain important revenue contributors through the decade. To support our next wave of growth, we also have an exciting and diverse pipeline of promising new therapies to address critical unmet needs in both blood cancers and solid tumors. Notable opportunities from our mid- to late-stage oncology pipeline include: navitoclax for myelofibrosis, which has the potential to provide disease modification in a market where current treatments only address symptoms; epcoritamab, a potentially best-in-class CD3xCD20 for B-cell malignancies, including DLBCL and follicular lymphoma; ABBV-383, our BCMA CD3 bispecific, which has the potential to become a best-in-class treatment in multiple myeloma; and Teliso-V, our promising c-Met ADC being studied for nonsquamous non-small cell lung cancer, which was recently granted Breakthrough Therapy Designation.

在血液腫瘤學領域，我們與 Imbruvica 和 Venclexta 建立了領先地位，預計這兩家公司在未來十年仍將是重要的收入貢獻者。為了支持我們的下一波增長，我們還擁有令人興奮且多樣化的有前景的新療法管道，以解決血癌和實體瘤中未滿足的關鍵需求。我們中後期腫瘤學管道的顯著機會包括：用於骨髓纖維化的 navitoclax，它有可能在當前治療僅針對症狀的市場中提供疾病改良； epcoritamab，一種潛在的同類最佳 CD3xCD20，用於治療 B 細胞惡性腫瘤，包括 DLBCL 和濾泡性淋巴瘤； ABBV-383，我們的 BCMA CD3 雙特異性藥物，有潛力成為治療多發性骨髓瘤的同類最佳療法；和 Teliso-V，我們有前途的 c-Met ADC 正在研究非鱗狀非小細胞肺癌，最近被授予突破性治療指定。

In neuroscience, we have a portfolio of compelling and differentiated therapies to support robust long-term growth in migraine, Parkinson's disease and psychiatric conditions. Ubrelvy and QULIPTA are both demonstrating strong launch trajectories in migraine, with each treatment expected to contribute more than $1 billion in peak sales. Vraylar continues to have a significant opportunity with currently approved indications with peak sales expected to approach $4 billion. An approval in major depressive disorder represents upside to our current projections. In 951, a potentially transformative improvement to our current treatment options for patients with advanced Parkinson's disease with peak sales also anticipated to be more than $1 billion.

在神經科學領域，我們擁有一系列引人注目的差異化療法，以支持偏頭痛、帕金森病和精神疾病的長期穩健增長。 Ubrelvy 和 QULIPTA 都展示了偏頭痛的強勁啟動軌跡，每種治療預計將貢獻超過 10 億美元的峰值銷售額。 Vraylar 繼續擁有重大機遇，目前已獲批准的適應症，峰值銷售額預計將接近 40 億美元。對重度抑鬱症的批准代表了我們當前預測的上行空間。在 951 中，我們目前針對晚期帕金森病患者的治療方案的潛在變革性改進預計銷售額將超過 10 億美元。

Our leading aesthetics portfolio represents another extremely attractive growth opportunity. This business is performing well above expectations, delivering full year 2021 sales of more than $5.2 billion, $700 million higher than our initial guidance. AbbVie's increased promotional investments are driving accelerated category growth, especially in toxins and fillers, where there is substantial room for additional market penetration globally.

我們領先的美學產品組合代表了另一個極具吸引力的增長機會。該業務的表現遠超預期，2021 年全年銷售額超過 52 億美元，比我們最初的指導高出 7 億美元。艾伯維（AbbVie）增加的促銷投資正在推動品類的加速增長，尤其是在毒素和填充劑領域，在全球市場滲透的空間很大。

Dedicated resources are also focused on delivering new product innovation within aesthetics with several exciting R&D programs internally, including both short-acting and long-acting toxins as well as novel fillers with biostimulatory or regenerative features. And we remain active with business development to pursue promising external technologies and complementary opportunities, including the recently closed Soliton acquisition, which further expands our body contouring portfolio. Given this focused investment, we expect our aesthetics franchise to deliver high single-digit revenue growth through the end of the decade, including sales of more than $9 billion in 2029.

專門的資源還專注於通過內部幾個令人興奮的研發計劃提供美學領域的新產品創新，包括短效和長效毒素以及具有生物刺激或再生功能的新型填充劑。我們繼續積極開展業務，以尋求有前景的外部技術和互補機會，包括最近完成的對 Soliton 的收購，這進一步擴大了我們的身體輪廓產品組合。鑑於這項集中投資，我們預計我們的美學專營權將在本十年末實現高個位數的收入增長，包括到 2029 年的銷售額超過 90 億美元。

Lastly, we've developed a robust pipeline, including numerous attractive late-stage programs, novel early-stage therapies and a growing range of potential platform technologies, which we expect will collectively contribute to our growth through the decade. With the actions that we've taken to diversify our sources of growth, we remain very confident in the long-term outlook for our business. Following the U.S. Humira LOE event in 2023, we expect to quickly return to growth in 2024 and deliver a high single-digit growth from 2025 to the end of the decade. This is a testament to the strength of AbbVie's broad and balanced portfolio.

最後，我們已經開發了一個強大的管道，包括許多有吸引力的後期項目、新穎的早期療法和越來越多的潛在平台技術，我們預計這些技術將共同為我們在十年內的增長做出貢獻。通過我們為實現增長來源多元化而採取的行動，我們對業務的長期前景仍然充滿信心。繼 2023 年美國 Humira LOE 事件之後，我們預計將在 2024 年迅速恢復增長，並在 2025 年至本世紀末實現高個位數增長。這證明了 AbbVie 廣泛而平衡的投資組合的實力。

In summary, this is an exciting time for our company. We're demonstrating excellent execution across our portfolio, and our long-term growth prospects remain very strong.

總之，這對我們公司來說是一個激動人心的時刻。我們在我們的投資組合中展示了出色的執行力，我們的長期增長前景仍然非常強勁。

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

有了這個，我會把電話轉給傑夫。傑夫?

Thank you, Rick. Looking at our quarterly results, we continue to demonstrate excellent commercial execution across our therapeutic portfolio. I'll start with immunology, which delivered global revenues of more than $6.7 billion, reflecting growth of 13.3% on an operational basis. Global Humira sales were $5.3 billion, up 3.5%, with 6% revenue growth in the U.S., offset by biosimilar competition across the international markets where revenues were down 8.8% on an operational basis.

謝謝你，瑞克。從我們的季度業績來看，我們繼續在我們的治療產品組合中展示出色的商業執行力。我將從免疫學開始，它帶來了超過 67 億美元的全球收入，在運營基礎上反映了 13.3% 的增長。全球 Humira 銷售額為 53 億美元，增長 3.5%，其中美國的收入增長 6%，但被國際市場的生物仿製藥競爭所抵消，其中收入在運營基礎上下降了 8.8%。

Skyrizi is performing extremely well. Global sales of nearly $900 million were up 12.4% on a sequential basis, reflecting continued market share gains. Skyrizi has now surpassed Humira as the leader for total prescriptions in the U.S. psoriasis biological market with share of approximately 20%. We are also now leading the market in several international geographies, including Japan.

Skyrizi 的表現非常出色。近 9 億美元的全球銷售額環比增長 12.4%，反映出市場份額的持續增長。 Skyrizi 現在已經超過 Humira 成為美國銀屑病生物市場總處方的領導者，份額約為 20%。我們現在還在包括日本在內的多個國際地區引領市場。

Total in-play share, which includes both new and switching patients, remains very strong and now reflects roughly 37% patient share in the U.S. as well as leadership in nearly 20 key countries around the world. Skyrizi is also now approved for its second major indication, to treat adults with active psoriatic arthritis, further enhancing its compelling profile in dermatology. Field promotion is now active globally, and early feedback from physicians has been very positive, given Skyrizi's demonstrated skin clearance and joint efficacy in our PsA clinical program. With nearly 30% of patients visiting dermatologists having both skin and joint involvement, this new approval will sustain Skyrizi's strong momentum.

包括新患者和轉換患者在內的總在場份額仍然非常強勁，現在反映了美國約 37% 的患者份額以及在全球近 20 個主要國家/地區的領導地位。 Skyrizi 現在也被批准用於其第二個主要適應症，用於治療患有活動性銀屑病關節炎的成人，進一步增強其在皮膚病學中的引人注目的形象。鑑於 Skyrizi 在我們的 PsA 臨床項目中表現出的皮膚清除和聯合療效，目前全球範圍內的現場推廣活動十分活躍，醫生的早期反饋非常積極。近 30% 的患者到皮膚科就診時有皮膚和關節受累，這一新批准將維持 Skyrizi 的強勁勢頭。

In addition, we are preparing for the launch of Skyrizi in Crohn's disease, an indication with very meaningful long-term revenue potential, with regulatory approvals in both the U.S. and Europe anticipated this year.

此外，我們正準備在克羅恩病中推出 Skyrizi，這是一個具有非常有意義的長期收入潛力的跡象，預計今年將在美國和歐洲獲得監管批准。

Rinvoq also continues to demonstrate robust growth. Global sales of more than $500 million were up 14% on a sequential basis. Prescriptions in RA remain strong, with a total market share of more than 5.5% in the U.S. and nearly 5% across key international markets. We're very pleased with the competitive labels for both PsA and atopic dermatitis, where we are making excellent progress with their launches globally.

Rinvoq 也繼續表現出強勁的增長。全球銷售額超過 5 億美元，環比增長 14%。 RA 處方仍然強勁，在美國的總市場份額超過 5.5%，在主要國際市場的總市場份額接近 5%。我們對 PsA 和特應性皮炎的競爭標籤感到非常滿意，我們在全球範圍內的推出取得了巨大進展。

In atopic dermatitis, dermatologists appreciate key elements of Rinvoq's new label, including the incorporation of stringent skin and itch end points, reflective of the performance in our registrational trials, as well as an adolescent indication and dosing flexibility. Managed care access is expected to ramp fairly quickly for both atopic dermatitis and PsA in the U.S. We are also preparing for the launches of Rinvoq in ulcerative colitis and axial SpA, with regulatory approvals for both indications anticipated this year as well.

在特應性皮炎方面，皮膚科醫生讚賞 Rinvoq 新標籤的關鍵要素，包括納入嚴格的皮膚和瘙癢終點，反映了我們註冊試驗的表現，以及青少年適應症和劑量靈活性。預計美國的特應性皮炎和 PsA 的管理式護理訪問將相當快地增加。我們還準備推出 Rinvoq 治療潰瘍性結腸炎和軸性 SpA，預計今年這兩種適應症也將獲得監管批准。

Overall, we continue to feel very good about the performance and progress we are making with both Rinvoq and Skyrizi, which are expected to contribute more than $15 billion in combined risk-adjusted global sales in 2025.

總體而言，我們繼續對 Rinvoq 和 Skyrizi 的業績和進展感到非常滿意，預計到 2025 年，這兩家公司的風險調整後全球總銷售額將超過 150 億美元。

In hematologic oncology, global revenues were nearly $1.9 billion, up 4.7% on an operational basis. Venclexta once again delivered robust growth. Sales were up 34% on an operational basis with strong share performance across all approved indications. Imbruvica global revenues were down 2.7%, reflecting a slower-than-anticipated market recovery in CLL and increased share pressure from newer therapies.

在血液腫瘤學領域，全球收入接近 19 億美元，在運營基礎上增長 4.7%。 Venclexta 再次實現強勁增長。銷售額在運營基礎上增長了 34%，在所有批准的適應症中表現強勁。 Imbruvica 全球收入下降 2.7%，反映出 CLL 市場復甦慢於預期以及新療法帶來的份額壓力增加。

In neuroscience, revenues were more than $1.6 billion, up 19% on an operational basis, including robust double-digit growth for both Vraylar and Botox Therapeutic.

在神經科學領域，收入超過 16 億美元，在運營基礎上增長 19%，其中 Vraylar 和 Botox Therapeutic 均實現了兩位數的強勁增長。

I'm also very pleased with our performance in migraine, where we have a portfolio of multiple distinct therapies to address the full spectrum of this disease. This includes our 2 leading oral CGRP therapies: Ubrelvy for acute migraine, which delivered total sales of $183 million, up 13% on a sequential basis. We anticipate robust sales growth again this year based on Ubrelvy's competitive profile, continued strong new patient starts and a rapidly expanding CGRP segment.

我也對我們在偏頭痛方面的表現感到非常滿意，我們有多種不同的療法來解決這種疾病的全部範圍。這包括我們的兩種領先的口服 CGRP 療法：治療急性偏頭痛的 Ubrelvy，其總銷售額為 1.83 億美元，環比增長 13%。基於 Ubrelvy 的競爭優勢、持續強勁的新患者啟動和快速擴張的 CGRP 細分市場，我們預計今年銷售將再次強勁增長。

And we also have QULIPTA, the only oral CGRP treatment specifically developed for the prevention of episodic migraine. The launch is going extremely well. When considering both paid and bridge volume, QULIPTA is already capturing nearly 20% of the new-to-brand share in the preventative CGRP class. Roughly 3 months post launch, this is an incredible accomplishment, and it's a testament to QULIPTA's demonstrated efficacy, including rapid and meaningful reduction in migraine days. We expect commercial access for QULIPTA to ramp quickly in the first half of this year.

我們還有 QULIPTA，這是唯一一種專門為預防發作性偏頭痛而開發的口服 CGRP 治療。發射進展非常順利。在考慮付費和過橋交易量時，QULIPTA 已經在預防性 CGRP 類別中佔據了近 20% 的新品牌份額。發布後大約 3 個月，這是一項令人難以置信的成就，它證明了 QULIPTA 已證明的功效，包括快速且有意義地減少偏頭痛天數。我們預計 QULIPTA 的商業准入將在今年上半年迅速增加。

In eye care, revenues of $960 million were up 3.9% on an operational basis, including $364 million in sales from Restasis. Lastly, Mavyret sales were $427 million, down 10.1% on an operational basis as treated patient volumes remain suppressed compared to pre-COVID levels.

在眼部護理方面，營業收入為 9.6 億美元，增長 3.9%，其中包括來自 Restasis 的 3.64 億美元的銷售額。最後， Mavyret 的銷售額為 4.27 億美元，在運營基礎上下降了 10.1%，因為與 COVID 之前的水平相比，治療的患者數量仍然受到抑制。

Overall, I'm very pleased with the performance and the momentum across the therapeutic portfolio. And with that, I'll turn the call over to Mike for additional comments on our R&D programs. Mike?

總的來說，我對整個治療組合的表現和勢頭感到非常滿意。有了這個，我將把電話轉給 Mike，以獲得對我們研發計劃的更多評論。麥克風？

Thank you, Jeff. We made significant advancement across all stages of our pipeline in 2021, and we expect continued progress again this year. In immunology, we had several recent important regulatory updates. We implemented safety and indication updates to our RA label for Rinvoq and also received FDA approval in psoriatic arthritis and atopic dermatitis, securing strong labels that highlight Rinvoq's favorable benefit-risk profile in both new indications.

謝謝你，傑夫。 2021 年，我們在管道的所有階段都取得了重大進展，我們預計今年將再次取得進展。在免疫學方面，我們最近有幾項重要的監管更新。我們對 Rinvoq 的 RA 標籤實施了安全性和適應症更新，並在銀屑病關節炎和特應性皮炎方面獲得了 FDA 的批准，確保了強有力的標籤，突出了 Rinvoq 在這兩種新適應症中的有利利益風險概況。

In atopic dermatitis, we received approval for both the 15- and 30-milligram doses. And based on the impressive levels of skin clearance and itch reduction demonstrated in our development program, we believe Rinvoq will be an important new treatment option for adult and adolescent patients with moderate-to-severe atopic dermatitis who have not responded well to other systemic agents such as cyclosporine, methotrexate, azathioprine or biologics.

在特應性皮炎中，我們獲得了 15 和 30 毫克劑量的批准。基於我們的開發計劃中顯示的令人印象深刻的皮膚清除和瘙癢減少水平，我們相信 Rinvoq 將成為對其他全身性藥物反應不佳的中度至重度特應性皮炎成人和青少年患者的重要新治療選擇如環孢素、甲氨蝶呤、硫唑嘌呤或生物製劑。

We also have regulatory applications under review for Rinvoq in ulcerative colitis, ankylosing spondylitis and non-radiographic axial SpA. We expect an FDA approval decision next month for ulcerative colitis, in the second quarter for ankylosing spondylitis and in the fourth quarter for non-radiographic axial SpA. In Europe, we anticipate approval decisions for ulcerative colitis and non-radiographic axial SpA in the second half of the year.

我們還在審查 Rinvoq 在潰瘍性結腸炎、強直性脊柱炎和非放射軸性 SpA 中的監管申請。我們預計 FDA 將在下個月批准潰瘍性結腸炎，第二季度批准強直性脊柱炎，第四季度批准非放射軸性 SpA。在歐洲，我們預計將在今年下半年做出潰瘍性結腸炎和非放射軸性 SpA 的批准決定。

We're nearing completion of Rinvoq's registrational program in Crohn's disease, which is the last major indication expansion program for Rinvoq. We recently announced positive top line results from the first Phase III Crohn's induction study, where Rinvoq demonstrated a very strong impact on clinical remission and endoscopic response in a difficult-to-treat refractory patient population. We expect to see results from the second Phase III Crohn's induction study and from the maintenance study in the first half of this year with regulatory submissions anticipated in the second half of 2022.

我們即將完成 Rinvoq 在克羅恩病中的註冊計劃，這是 Rinvoq 的最後一個主要適應症擴展計劃。我們最近公佈了首個 III 期 Crohn 誘導研究的積極頂線結果，其中 Rinvoq 在難以治療的難治性患者群體中表現出對臨床緩解和內窺鏡反應的強烈影響。我們預計將在今年上半年看到第二階段 III 克羅恩的誘導研究和維持研究的結果，並預計在 2022 年下半年提交監管文件。

Also in immunology, we recently received FDA approval for Skyrizi in psoriatic arthritis, an important indication expansion for this asset. Based on the strong joint efficacy and the high level of skin clearance that Skyrizi provided in our registrational trials, we believe Skyrizi will be very competitively positioned as an effective new treatment option for psoriatic arthritis patients.

同樣在免疫學方面，我們最近獲得了 FDA 批准 Skyrizi 治療銀屑病關節炎，這是該資產的重要適應症擴展。基於 Skyrizi 在我們的註冊試驗中提供的強大的聯合療效和高水平的皮膚清除率，我們相信 Skyrizi 將作為銀屑病關節炎患者的一種有效的新治療選擇極具競爭力。

We also have regulatory applications under review for Skyrizi in Crohn's disease with approval decisions expected in the U.S. next month and in Europe later this year. We've seen impressive results in our Crohn's disease program, and we believe Skyrizi has the potential to become an important new therapy in this market where there continues to be considerable unmet need.

我們還在審查克羅恩病中 Skyrizi 的監管申請，預計下個月在美國和今年晚些時候在歐洲作出批准決定。我們已經在克羅恩病項目中看到了令人印象深刻的成果，我們相信 Skyrizi 有潛力成為這個市場上重要的新療法，在這個市場上仍有相當大的未滿足需求。

We're making very good progress with our early-stage immunology pipeline as well, where we are developing novel agents with the goal of significantly advancing the standard of care across our core areas by providing deeper and more durable responses.

我們的早期免疫學管道也取得了非常好的進展，我們正在開發新的藥物，目標是通過提供更深入和更持久的反應來顯著提高我們核心領域的護理標準。

Our anti-TNF steroid ADC, ABBV-154, is a novel approach for delivering a potent steroid that has the potential to provide durable remission in diseases such as RA, PMR and Crohn's disease. We expect to see preliminary data from our Phase II dose-ranging study in RA in the fourth quarter of this year. We also expect to see Phase II proof-of-concept data in PMR and Crohn's disease in 2023.

我們的抗 TNF 類固醇 ADC ABBV-154 是一種新方法，用於提供一種強效類固醇，有可能為 RA、PMR 和克羅恩病等疾病提供持久緩解。我們希望在今年第四季度看到我們在 RA 的 II 期劑量範圍研究的初步數據。我們還希望在 2023 年看到 PMR 和克羅恩病的 II 期概念驗證數據。

In dermatology, our early-stage efforts are focused on developing oral agents that can provide clear skin with durable responses. Our RORgamma t inverse agonist, ABBV-157, is designed to more effectively inhibit IL-17 production compared to pure antagonists, which has the potential to result in a greater impact on skin inflammation. We recently began a Phase II dose-ranging study for 157 in psoriasis.

在皮膚病學方面，我們的早期工作重點是開發能夠提供清晰皮膚和持久反應的口服藥物。與純拮抗劑相比，我們的 RORgamma t 反向激動劑 ABBV-157 旨在更有效地抑制 IL-17 的產生，這有可能對皮膚炎症產生更大的影響。我們最近開始了一項針對 157 名銀屑病患者的 II 期劑量範圍研究。

Moving to oncology, where we continue to make good progress across all stages of our pipeline. We recently received an FDA Breakthrough Therapy Designation for Teliso-V and second-line-plus advanced or metastatic nonsquamous non-small cell lung cancer based on the encouraging results we've seen to date in our clinical program. Treatment options for patients who have exhausted platinum-based chemotherapy, immunotherapy and targeted therapy are limited to single-agent chemo, which typically provides response rates of only 15% to 20% with a median overall survival of less than 1 year. Prognosis for these patients is very poor.

轉向腫瘤學，我們繼續在管道的所有階段取得良好進展。基於我們迄今為止在臨床項目中看到的令人鼓舞的結果，我們最近收到了 FDA 對 Teliso-V 和二線加晚期或轉移性非鱗狀非小細胞肺癌的突破性治療指定。已用盡鉑類化療、免疫治療和靶向治療的患者的治療選擇僅限於單藥化療，其反應率通常僅為 15% 至 20%，中位總生存期不到 1 年。這些患者的預後非常差。

While targeted therapies have been approved by the FDA for the 3% to 4% of non-small cell lung cancer patients harboring MET exon 14 skipping mutations, there are currently no therapies approved, specifically for the much larger group of patients who exhibit c-Met protein overexpression. Patients with overexpressed c-Met represent about 25% to 30% of the advanced or metastatic nonsquamous non-small cell lung cancer population with wild-type EGFR, which corresponds to an incidence of approximately 35,000 patients each year in the U.S.

儘管 FDA 已批准靶向治療用於 3% 至 4% 的攜帶 MET 外顯子 14 跳躍突變的非小細胞肺癌患者，但目前還沒有批准的治療方法，特別是針對錶現出 c- Met 蛋白過表達。過表達 c-Met 的患者約佔具有野生型 EGFR 的晚期或轉移性非鱗狀非小細胞肺癌人群的 25% 至 30%，這相當於美國每年約 35,000 名患者的發病率。

In Stage 1 of our Phase II study, we saw promising efficacy in heavily pretreated patients who received Teliso-V, including a 54% objective response rate in those with highly expressed c-Met. The second stage of the Phase II study is ongoing and has the potential to support an accelerated approval in second-line-plus advanced metastatic nonsquamous non-small cell lung cancer. We expect to see additional data from this study next year.

在我們 II 期研究的第 1 階段，我們在接受 Teliso-V 的大量預處理患者中看到了有希望的療效，包括在 c-Met 高表達患者中的 54% 的客觀反應率。 II 期研究的第二階段正在進行中，並有可能支持加速批准二線加晚期轉移性非鱗狀非小細胞肺癌。我們預計明年會從這項研究中看到更多數據。

We also recently began the clinical program for our next-generation c-Met ADC, ABBV-400, which utilizes a more potent topoisomerase inhibitor payload to potentially drive deeper tumor responses in patients with both intermediate and high levels of c-Met expression.

我們最近還開始了我們的下一代 c-Met ADC ABBV-400 的臨床計劃，它利用更有效的拓撲異構酶抑製劑有效載荷來潛在地驅動具有中等和高水平 c-Met 表達的患者的更深層次的腫瘤反應。

We also expect to see data this year from several important indication expansion programs for Venclexta, including results from the Phase III CANOVA trial in relapsed/refractory multiple myeloma patients with a t(11;14) mutation as well as results from our program for Venclexta in previously untreated higher-risk MDS patients, where we received a Breakthrough Therapy Designation.

我們還預計今年將看到 Venclexta 的幾個重要適應症擴展計劃的數據，包括在具有 at(11;14) 突變的複發/難治性多發性骨髓瘤患者中進行的 III 期 CANOVA 試驗的結果以及我們在 Venclexta 的計劃的結果以前未經治療的高危 MDS 患者，我們獲得了突破性治療指定。

We plan to submit our regulatory applications to the FDA in the first half of this year for an accelerated approval in MDS and late in '22 or early '23 for multiple myeloma. Both indications represent important expansion opportunities for Venclexta and will help drive long-term growth for our oncology portfolio.

我們計劃在今年上半年向 FDA 提交我們的監管申請，以加速 MDS 的批准，並在 22 年末或 23 年初多發性骨髓瘤。這兩個跡像都代表了 Venclexta 的重要擴張機會，並將有助於推動我們腫瘤學產品組合的長期增長。

We are also making very good progress with epcoritamab, where we continue to generate strong data in early-stage studies to support our view that epcoritamab has the potential to become a differentiated and best-in-class CD3xCD20 bispecific across several B-cell malignancies, including diffuse B cell and follicular lymphomas.

我們在 epcoritamab 方面也取得了非常好的進展，我們繼續在早期研究中產生強大的數據，以支持我們的觀點，即 epcoritamab 有可能成為一種分化和同類最佳的 CD3xCD20 雙特異性藥物，用於多種 B 細胞惡性腫瘤，包括瀰漫性B細胞淋巴瘤和濾泡性淋巴瘤。

We'll see monotherapy data in the third quarter from the Phase II expansion cohort in DLBCL, which has the potential to support a submission for accelerated approval in the second half of this year. We also have a Phase III study ongoing in third-line relapsed/refractory DLBCL, and we plan to initiate several additional Phase III trials this year, including studies in earlier lines of therapy for diffuse B-cell lymphoma in multiple combinations, as well as in follicular lymphoma in combination with rituximab and Revlimid.

我們將在第三季度看到來自 DLBCL 的 II 期擴展隊列的單藥治療數據，這有可能支持在今年下半年提交加速批准。我們還在三線復發/難治性 DLBCL 中進行了一項 III 期研究，我們計劃在今年啟動幾項額外的 III 期試驗，包括早期治療多種組合的瀰漫性 B 細胞淋巴瘤的研究，以及與利妥昔單抗和 Revlimid 聯合用於濾泡性淋巴瘤。

This year, we'll also see additional data maturing from our cohort expansion studies for ABBV-383, both as a monotherapy and in combinations with standard of care and novel agents in multiple myeloma. We believe our BCMA CD3 bispecific has the potential to be differentiated on efficacy, safety and dosing interval and can be best-in-class across multiple lines of therapy. We plan to initiate Phase III studies later this year in relapsed/refractory multiple myeloma.

今年，我們還將看到來自 ABBV-383 的隊列擴展研究的更多數據成熟，無論是作為單一療法，還是與多發性骨髓瘤的標準護理和新型藥物組合。我們相信，我們的 BCMA CD3 雙特異性有可能在療效、安全性和給藥間隔方面有所區別，並且可以在多個治療線中成為同類最佳。我們計劃在今年晚些時候啟動復發/難治性多發性骨髓瘤的 III 期研究。

We also continue to make good progress with navitoclax in myelofibrosis, where we've seen strong mid-stage data supporting our view that navitoclax has the potential to provide disease modification, which we believe will lead to improved and durable clinical outcomes for patients. We expect a Phase III data readout and regulatory submissions in the first half of next year, with approval anticipated near the end of 2023.

我們還在 navitoclax 治療骨髓纖維化方面繼續取得良好進展，我們已經看到強大的中期數據支持我們的觀點，即 navitoclax 有可能提供疾病改善，我們相信這將為患者帶來改善和持久的臨床結果。我們預計明年上半年將進行 III 期數據讀出和監管提交，預計將在 2023 年底附近獲得批准。

Moving to neuroscience, where we expect several important pipeline events in 2022 as well. We recently completed discussions with the FDA and are preparing to submit our application for Vraylar as an adjunctive treatment for major depressive disorder. Based on the totality of the data and the strong benefit-risk profile demonstrated in our clinical program, we believe Vraylar has the potential to be competitively positioned as an adjunctive treatment for major depressive disorder. We expect a submission in the first quarter and an approval decision by the end of the year.

轉向神經科學，我們預計 2022 年還將有幾項重要的管道事件。我們最近完成了與 FDA 的討論，並準備提交我們的 Vraylar 申請，作為重度抑鬱症的輔助治療。基於全部數據和我們臨床項目中展示的強大的收益-風險概況，我們相信 Vraylar 有可能成為重度抑鬱症的輔助治療藥物。我們預計將在第一季度提交申請，並在年底前做出批准決定。

We've also completed our registration-enabling program for ABBV-951, our novel subcutaneous levodopa/carbidopa delivery system for treatment of advanced Parkinson's disease. In our Phase III studies, 951 proved superior to oral levodopa/carbidopa in reducing motor fluctuations in this advanced population, and we believe our innovative new delivery system represents a potentially transformative improvement to current treatment options. We remain on track to submit our regulatory applications in the first half of this year in the U.S. and Europe, with both approval decisions anticipated in early 2023.

我們還完成了 ABBV-951 的註冊授權計劃，這是我們用於治療晚期帕金森病的新型皮下左旋多巴/卡比多巴給藥系統。在我們的 III 期研究中，951 在減少這一先進人群的運動波動方面被證明優於口服左旋多巴/卡比多巴，我們相信我們創新的新遞送系統代表了對當前治療方案的潛在變革性改進。我們仍有望在今年上半年在美國和歐洲提交監管申請，預計將在 2023 年初做出兩項批准決定。

And we expect to see Phase III data for QULIPTA in chronic migraine prevention later in the first quarter and plan to submit our regulatory applications in both the U.S. and Europe this summer, with approval decisions expected in the first half of 2023.

我們預計將在第一季度晚些時候看到 QULIPTA 在慢性偏頭痛預防方面的 III 期數據，併計劃於今年夏天在美國和歐洲提交我們的監管申請，預計將在 2023 年上半年做出批准決定。

So in summary, we remain focused on continuing to execute on our pipeline programs and anticipate numerous important regulatory and clinical milestones across all stages of our pipeline in 2022. This includes important indication expansion for on-market drugs and data readouts and regulatory actions for key late-stage assets as well as proof-of-concept data from several early-stage NME programs.

因此，總而言之，我們仍然專注於繼續執行我們的管道計劃，並預計在 2022 年我們管道所有階段的許多重要的監管和臨床里程碑。這包括對上市藥物和數據讀出的重要適應症擴展以及關鍵的監管行動後期資產以及來自幾個早期 NME 計劃的概念驗證數據。

With that, I'll turn the call over to Rob for additional comments on our fourth quarter performance and our 2022 financial outlook. Rob?

有了這個，我將把電話轉給 Rob，以徵求對我們第四季度業績和 2022 年財務前景的更多評論。搶？

Thank you, Mike. AbbVie once again delivered outstanding performance while also advancing our strategic priorities. The strong results across our portfolio continue to support AbbVie's long-term growth outlook.

謝謝你，邁克。艾伯維（AbbVie）再次表現出色，同時也推進了我們的戰略重點。我們投資組合的強勁業績繼續支持艾伯維的長期增長前景。

Starting with fourth quarter results. We reported adjusted earnings per share of $3.31, up 13.4% compared to prior year and $0.05 above our guidance midpoint. Total adjusted net revenues were $14.9 billion, up 7.5% on an operational basis, excluding a 0.1% unfavorable impact from foreign exchange.

從第四季度的結果開始。我們報告調整後的每股收益為 3.31 美元，比去年同期增長 13.4%，比我們的指導中點高 0.05 美元。調整後的總淨收入為 149 億美元，在運營基礎上增長 7.5%，不包括外匯帶來的 0.1% 的不利影響。

The adjusted operating margin ratio was 49.3% of sales, an improvement of 240 basis points versus the prior year. This includes adjusted gross margin of 83.6% of sales, adjusted R&D investment of 12.1% of sales and adjusted SG&A expense of 22.2% of sales. Net interest expense was $571 million, and the adjusted tax rate was 12.5%.

調整後的營業利潤率為銷售額的 49.3%，比上年提高 240 個基點。這包括調整後的毛利率佔銷售額的 83.6%，調整後的研發投資佔銷售額的 12.1%，調整後的 SG&A 費用佔銷售額的 22.2%。淨利息支出為 5.71 億美元，調整後稅率為 12.5%。

Shifting to 2022. Our full year adjusted earnings per share guidance is between $14 and $14.20, reflecting growth of 11% at the midpoint. Excluded from this guidance is $4.74 of known intangible amortization and specified items. We expect adjusted net revenue of approximately $60 billion. At current rates, we expect foreign exchange to have a 0.8% unfavorable impact on full year sales growth.

轉移到 2022 年。我們全年調整後的每股收益指引在 14 美元至 14.20 美元之間，反映了中點 11% 的增長。本指南不包括 4.74 美元的已知無形攤銷和指定項目。我們預計調整後的淨收入約為 600 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 0.8% 的不利影響。

This revenue forecast comprehends the following approximate assumptions for our key products and therapeutic areas. We expect immunology global sales to grow double digits, including U.S. Humira growth of 8%, international Humira revenue of $2.6 billion at current exchange rates, Skyrizi global sales of $4.4 billion and Rinvoq global sales of $2.7 billion.

該收入預測包含以下對我們的主要產品和治療領域的近似假設。我們預計免疫學全球銷售額將增長兩位數，包括美國 Humira 增長 8%，按當前匯率計算的國際 Humira 收入為 26 億美元，Skyrizi 全球銷售額為 44 億美元，Rinvoq 全球銷售額為 27 億美元。

In hematologic oncology, we expect Venclexta global sales of $2.3 billion and Imbruvica global revenue of $5.4 billion. The Imbruvica forecast assumes market recovery in CLL, offset by share erosion from increased competition.

在血液腫瘤學領域，我們預計 Venclexta 的全球銷售額為 23 億美元， Imbruvica 的全球收入為 54 億美元。 Imbruvica 的預測假設 CLL 市場復甦，但被競爭加劇導致的份額侵蝕所抵消。

For aesthetics, we expect global sales of $5.9 billion, including $2.6 billion for Botox Cosmetic and $1.7 billion from Juvederm.

在美學方面，我們預計全球銷售額為 59 億美元，其中 Botox Cosmetic 的 26 億美元和 Juvederm 的 17 億美元。

For neuroscience, we expect global revenue of $6.9 billion, including Botox Therapeutic sales of $2.7 billion, Vraylar sales of $2.2 billion, Ubrelvy sales of $800 million and QULIPTA sales up $200 million with commercial access increasing rapidly in the first half of the year.

對於神經科學，我們預計全球收入為 69 億美元，其中肉毒桿菌治療銷售額為 27 億美元，Vraylar 銷售額為 22 億美元，Ubrelvy 銷售額為 8 億美元，QULIPTA 銷售額增長 2 億美元，上半年商業准入迅速增加。

For eye care, we expect global sales of $2.9 billion, including $700 million from Restasis, which assumes no generic competition in the first half of 2022. Lastly, we expect Mavyret global revenue of $1.7 billion.

對於眼部護理，我們預計全球銷售額為 29 億美元，其中來自 Restasis 的 7 億美元，假設 2022 年上半年沒有仿製藥競爭。最後，我們預計 Mavyret 的全球收入為 17 億美元。

Looking at the P&L for 2022. We are forecasting full year adjusted gross margin of approximately 84% of sales, adjusted R&D investment of approximately $6.8 billion and adjusted SG&A expense of approximately $12.7 billion. This guidance includes approximately $2.5 billion in expense synergies from the Allergan acquisition. We are forecasting the adjusted operating margin ratio to expand by 120 basis points to approximately 51.5% of sales. We expect adjusted net interest expense approaching $2.2 billion, our non-GAAP tax rate to be approximately 12.7% and our share count to be roughly flat to 2021.

看看 2022 年的損益。我們預計全年調整後的毛利率約為銷售額的 84%，調整後的研發投資約為 68 億美元，調整後的 SG&A 費用約為 127 億美元。該指引包括來自艾爾建（Allergan）收購的約 25 億美元的費用協同效應。我們預計調整後的營業利潤率將擴大 120 個基點，達到銷售額的約 51.5%。我們預計調整後的淨利息支出接近 22 億美元，我們的非公認會計原則稅率約為 12.7%，我們的股票數量與 2021 年大致持平。

Turning to the first quarter. We anticipate net revenue approaching $13.5 billion. At current rates, we expect foreign exchange to have a 1.3% unfavorable impact on sales growth. This revenue forecast comprehends the following approximate assumptions for our key therapeutic areas: immunology sales of $6.2 billion, hem/onc revenue of $1.7 billion, aesthetic sales of $1.3 billion, neuroscience revenue of $1.5 billion and eye care sales of $900 million. We are forecasting an adjusted operating margin ratio of approximately 51% of sales, and we model a non-GAAP tax rate of 12.4%. We expect adjusted earnings per share between $3.10 and $3.14, excluding approximately $1.22 of known intangible amortization and specified items.

轉向第一季度。我們預計淨收入接近 135 億美元。按照目前的匯率，我們預計外匯將對銷售增長產生 1.3% 的不利影響。這一收入預測包含了我們主要治療領域的以下近似假設：免疫學銷售額為 62 億美元，hem/onc 收入為 17 億美元，美容銷售額為 13 億美元，神經科學收入為 15 億美元，眼科銷售額為 9 億美元。我們預測調整後的營業利潤率約為銷售額的 51%，我們對 12.4% 的非 GAAP 稅率進行建模。我們預計調整後的每股收益在 3.10 美元至 3.14 美元之間，不包括大約 1.22 美元的已知無形攤銷和指定項目。

Finally, AbbVie's strong business performance and outlook continue to support our capital allocation priorities. We expect to generate adjusted free cash flow of approximately $24 billion in 2022, which is net of roughly $1 billion in Skyrizi royalty payments. This cash flow will fully support a strong and growing dividend, which we have increased by more than 250% since inception; continued debt repayment, where we expect to pay down just above $12 billion of debt in 2022 and estimate a net leverage ratio of 1.8x by the end of the year. Our strong cash flow also allows for continued business development, with approximately $2 billion allocated annually to augment our pipeline with the most promising external technologies and innovative therapies.

最後，艾伯維強勁的業務表現和前景繼續支持我們的資本配置優先事項。我們預計到 2022 年將產生約 240 億美元的調整後自由現金流，其中扣除了約 10 億美元的 Skyrizi 特許權使用費。這種現金流將完全支持強勁且不斷增長的股息，自成立以來我們已經增加了 250% 以上；繼續償還債務，我們預計到 2022 年將償還略高於 120 億美元的債務，並估計到年底淨槓桿率為 1.8 倍。我們強勁的現金流還允許持續的業務發展，每年分配約 20 億美元用於使用最有前途的外部技術和創新療法來擴大我們的管道。

In closing, we are very pleased with AbbVie's strong results in 2021. And we expect to deliver robust performance in 2022 and over the long term. With that, I'll turn the call back over to Liz.

最後，我們對艾伯維在 2021 年的強勁業績感到非常滿意。我們預計將在 2022 年和長期提供強勁的業績。有了這個，我會把電話轉回給 Liz。

Thanks, Rob. We will now open the call for questions. (Operator Instructions) Operator, we'll take the first question.

謝謝，羅伯。我們現在將打開問題的電話。 （操作員說明）操作員，我們將回答第一個問題。

Our first question comes from Chris Schott with JPMorgan.

我們的第一個問題來自摩根大通的 Chris Schott。

I just have a couple here digging into Rinvoq in a little bit more detail. I guess, first in rheumatoid arthritis, can you just -- it looks like volumes have plateaued a little bit. It's probably not hugely surprising given label revision, but just elaborate a little bit more on the feedback you're getting from physicians there and when you anticipate you'll start to see sequential growth again in that indication.

我這裡有一對夫婦更詳細地研究了 Rinvoq。我想，首先是類風濕性關節炎，你能不能 - 看起來體積已經有點穩定了。考慮到標籤修訂，這可能並不令人驚訝，但只需詳細說明您從那裡的醫生那裡獲得的反饋，以及當您預計您將在該跡像中再次開始看到連續增長時。

The second question I had on Rinvoq was then on atopic derm. Just elaborate again a little bit more on the ramp you're expecting here. Is this something that's going to take some time? Or do you view that there's some low-hanging fruit maybe with some of the dupi failures? I'm really just trying to get to with all of these is, I guess, the $2.7 billion guidance, how much of that's RA? How much of it is new indication? Just a little bit more color on that front.

我對 Rinvoq 的第二個問題是關於特應性皮膚。只需再次詳細說明您在這裡期望的坡道。這是需要一些時間的事情嗎？或者您是否認為某些 dupi 的失敗可能會帶來一些唾手可得的成果？我真的只是想解決所有這些問題，我猜是 27 億美元的指導，其中有多少是 RA？其中有多少是新的適應症？只是在前面多一點顏色。

Yes. Thanks. It's Jeff. I'll give you some sense on what's happening with RA. So the RA market after the drug safety and label is progressing as we anticipated. So I'll give you some sense, and I'll refer to sort of in-play share because you have to be a little bit careful in the December, January time frame with overall volumes in the market.

是的。謝謝。是傑夫。我會給你一些關於 RA 發生了什麼的感覺。因此，藥物安全和標籤之後的 RA 市場正如我們預期的那樣發展。所以我會給你一些意義，我會提到某種在場份額，因為你必須在 12 月和 1 月的時間框架內對市場的整體交易量保持謹慎。

But right before the Drug Safety Communication, we had about a 16% in-play share in RA, which was just right behind Humira. So very, very strong. If we look at where that's trended over the fourth quarter, it's dropped about 20%, okay? So it's about 14% reported in October, just over 13% in November, very consistent with what we thought would happen. So about a 20% shift in new-to-brand starts over that time period.

但就在藥物安全通訊之前，我們在 RA 中擁有大約 16% 的在場份額，正好在 Humira 之後。非常非常強大。如果我們看看第四季度的趨勢，它下降了大約 20%，好嗎？因此，10 月份報告的比例約為 14%，11 月份略高於 13%，這與我們認為會發生的情況非常一致。因此，大約 20% 的新品牌在此期間開始轉變。

And what we see from the market is it's exactly as we would expect, very, very stable, no change really in second line plus and doctors start to suppress their starts in first-line consistent with the label. So what we're going to see is that as basically the promotion kicks back in here after December in the first quarter, we're going to see that type of stability, which we can see is very, very clear from our overall share in our weeklies and start to progress as we shift and pivot towards that second line plus. So the market is responding very similar to our expectations that we've been talking about in terms of overall RA.

而我們從市場上看到的正是我們所期望的，非常非常穩定，二線確實沒有變化，而且醫生開始壓制他們在一線的開始，與標籤一致。所以我們將看到的是，基本上促銷活動在 12 月之後的第一季度重新開始，我們將看到這種穩定性，我們可以從我們的整體份額中看到非常非常清楚我們的周刊並開始進步，因為我們轉向並轉向第二條線加。因此，市場對整體 RA 的反應與我們一直在談論的預期非常相似。

Obviously, PsA is going to help build upon that RA dynamic and then ultimately, later in the year, the big axial approvals as well. So everything is progressing as we thought it would progress from a market perspective.

顯然，PsA 將幫助建立在 RA 動態的基礎上，然後最終在今年晚些時候獲得大的軸向批准。所以一切都在進步，因為我們認為從市場的角度來看它會進步。

In terms of atopic dermatitis, listen, I said in my prepared remarks, we're very pleased with the label. We have those stringent end points of the EASI 90, the high skin clearance. Very powerful itch reduction are reflected in our label. We obviously have both doses approved. The market, I can tell you, has been very pleasantly surprised about the adolescent indication, which is -- it's very important.

關於特應性皮炎，聽我說，我在準備好的評論中說，我們對這個標籤非常滿意。我們有 EASI 90 的嚴格終點，即高皮膚清除率。我們的標籤中反映了非常強大的止癢效果。我們顯然已經批准了兩種劑量。我可以告訴你，市場對青少年適應症感到非常驚喜，這非常重要。

So that's basically -- we're going to start to see that ramp. It won't -- we don't think it's going to be slow. And to your point, in terms of our ability to start to capture patients, it's happening already. We obviously haven't reported any of the TRxs yet, but we can see it in the market. And typically, it's falling into a couple of areas. First, dupi failures, not a surprise, and there's a reasonably significant number of people after 4 or 5 years that just have failed and exited the market. They're going to come back in. We have reports from our research and our teams over partial responders to dupi that just aren't doing well, in particular with the itch. We see some early starts there.

所以這基本上是 - 我們將開始看到那個斜坡。它不會——我們認為它不會很慢。就您而言，就我們開始捕獲患者的能力而言，這已經發生了。我們顯然還沒有報告任何 TRx，但我們可以在市場上看到它。通常，它分為幾個領域。首先，dupi 失敗，這並不奇怪，而且在 4 或 5 年後，有相當多的人剛剛失敗並退出市場。他們會回來的。我們有來自我們的研究和我們的團隊的報告，其中部分響應者對 dupi 的反應並不好，尤其是瘙癢。我們在那裡看到了一些早期的開始。

And then, of course, challenging patients in general, we are seeing starts there as well with those higher levels of skin involvement. So the market seems to be progressing as we expected. It's not surprising that as we look at the development of the second-line market, we're going to see initially most of the starts in the dupi partial responders or the nonresponders, which is a fairly significant population.

然後，當然，一般來說，挑戰患者，我們看到從那裡開始，以及那些更高水平的皮膚參與。因此，市場似乎正如我們預期的那樣發展。毫不奇怪，當我們觀察二線市場的發展時，我們最初會看到大部分在 dupi 部分響應者或非響應者中開始，這是一個相當重要的人群。

Also, as I mentioned, that we will start to see our access ramp fairly quickly here over the first part of the year. So we're encouraged. Maybe I can turn it over to Rob to give a sense over the relative magnitude of the sales.

此外，正如我所提到的，我們將在今年上半年開始相當快地看到我們的訪問量增加。所以我們很受鼓舞。也許我可以把它交給 Rob，讓他了解銷售的相對規模。

Thanks, Jeff. Chris, this is Rob. So of the Rinvoq guidance of $2.7 billion, the AD and spine indications will each contribute a couple of hundred million dollars, while UC will contribute around $100 million. You need to keep in mind -- in terms of sequential growth, keep in mind, in the U.S., you tend to see from Q4 to Q1, it's a sequential decline. So that's just a seasonal dynamic that we see across the business. So you would see sequential growth resume in Q2 and beyond.

謝謝，傑夫。克里斯，這是羅伯。因此，在 Rinvoq 的 27 億美元指導中，AD 和脊柱適應症將各貢獻幾億美元，而 UC 將貢獻約 1 億美元。你需要記住——就連續增長而言，請記住，在美國，你往往會看到從第四季度到第一季度，這是一個連續下降。所以這只是我們在整個業務中看到的季節性動態。因此，您會看到第二季度及以後的連續增長恢復。

Our next question comes from Ronny Gal from Bernstein.

我們的下一個問題來自 Bernstein 的 Ronny Gal。

Nice quarter. First question is around Humira. I was wondering if you guys will be in a position to give us some sort of a floor number in 2023 based on payer contracts. Sometimes this year, obviously, the market is looking for that. And then when I talk to payers, it seems a lot of the decisions about what product they would use longer term will not happen in 2023. That will happen in 2024. You kind of talked about kind of like a decline and then a quick ramp-up. Do you see the floor here in 2023? Or do you see it in 2024?

漂亮的季度。第一個問題是關於修美樂。我想知道你們是否能夠根據付款人合同在 2023 年向我們提供某種樓層號碼。今年有時，顯然，市場正在尋找這一點。然後當我與付款人交談時，似乎很多關於他們將長期使用什麼產品的決定不會在 2023 年發生。這將在 2024 年發生。你談到的有點像下降，然後是快速上升-向上。您看到 2023 年的地板了嗎？或者你會在 2024 年看到它嗎？

And then if I could sneak one more. You have one of the largest differences between GAAP and non-GAAP earnings in the industry because of that Allergan acquisition. As you look at the amortization period and so forth, when do you think this thing will begin to narrow in a significant way just because that's a concern for some investors?

然後，如果我可以再偷偷摸摸一次。由於收購艾爾建，您擁有業內公認會計準則和非公認會計準則收益之間最大的差異之一。當您查看攤銷期等時，您認為這件事什麼時候會因為一些投資者的擔憂而開始顯著縮小？

Okay. Ronny, this is Rick Gonzalez. I'll take the Humira questions. I think if you look at the guidance we provided thus far, I mean, I think that's consistent with how we see the market playing out overall. We've said basically you should be thinking about 45% erosion, plus or minus 10%, that's probably a reasonable range. Nothing has really given us any indication that it should be different than that at this point.

好的。羅尼，這是里克岡薩雷斯。我會回答 Humira 的問題。我認為，如果您查看我們迄今為止提供的指導，我的意思是，我認為這與我們對市場整體表現的看法一致。我們已經說過，基本上你應該考慮 45% 的侵蝕，正負 10%，這可能是一個合理的範圍。沒有任何跡象表明它應該與此時有所不同。

I think we will be in a position as we move later on this year to potentially be able to provide some more specificity around that. We should be through all of the contracting at that point, in a better position to be able to understand the ramp and the change that will occur over that period of time, and we certainly want to provide guidance when we have confidence that we can give you a high degree of specificity of what that guidance looks like.

我認為我們將在今年晚些時候採取行動，以便有可能提供更多的具體細節。我們應該在那個時候完成所有的合同，處於更好的位置，以便能夠理解在這段時間內將發生的變化和變化，當我們有信心可以提供指導時，我們當然希望提供指導您對該指南的外觀有高度的特異性。

As it relates to your question about will the floor for Humira -- I think your question is, what will the floor for Humira be in '23 or '24? And I believe you'll see further erosion from '23 to '24 on the Humira business alone. But what we have described is we returned to growth on the overall business. So you have to think about it from the perspective of this underlying growth engine that gets suppressed in '23 by the significant erosion that you see around Humira, both price and some volume. And then as that continues, it continues at a slower pace when we get into '24. So the overall business has the ability to be able to drive growth for the total company. But yes, Humira would continue to decline in '24. And then Rob, why don't you cover the third one?

因為它與您關於 Humira 的地板的問題有關——我認為您的問題是，Humira 的地板在 23 年或 24 年會是什麼？而且我相信，從 23 年到 24 年，僅 Humira 業務就會進一步受到侵蝕。但我們所描述的是我們恢復了整體業務的增長。所以你必須從這個潛在的增長引擎的角度來考慮它，它在 23 年被你在 Humira 周圍看到的顯著侵蝕所抑制，無論是價格還是一些數量。然後隨著這種情況的繼續，當我們進入 24 年時，它會以較慢的速度繼續下去。因此，整體業務有能力推動整個公司的增長。但是，是的，修美樂會在 24 年繼續下降。然後 Rob，你為什麼不報導第三個？

Sure. Ronny, this is Rob. So when you look at our adjustments to specified intangible amortization, I'd say intangible amortization is like 70% of it. This is on the $4.74 guidance that we've given this year. And that will continue. Obviously, those things fall off over a number of years. But I would say that's probably a level that I would assume would be present for the next several years.

當然。羅尼，這是羅布。因此，當您查看我們對指定無形攤銷的調整時，我會說無形攤銷就像其中的 70%。這是我們今年給出的 4.74 美元指導。這將繼續下去。顯然，這些東西會在幾年後消失。但我會說這可能是我認為未來幾年會出現的水平。

Another big component is Skyrizi contingent consideration given that we're -- that's purchase accounting, and we record that accretion as such. That will certainly fluctuate over time. But I'd say those are the 2 biggest components of the guide this year. And certainly, integration costs are starting to wind down. So you would expect to see those come down. But it is going down from last year. And so you would expect it potentially trend down. But overall, I think you can model this level going forward.

另一個重要組成部分是 Skyrizi 或有考慮，因為我們是 - 那是採購會計，我們記錄了這種增長。這肯定會隨著時間的推移而波動。但我想說這些是今年指南的兩個最大組成部分。當然，整合成本開始下降。所以你會期望看到那些下降。但比去年有所下降。所以你會預期它可能會下降。但總的來說，我認為你可以在未來對這個級別進行建模。

Our next question comes from Andrew Baum with Citi.

我們的下一個問題來自花旗銀行的 Andrew Baum。

A couple of questions. Firstly, on Imbruvica. As we move into 2022 and the COVID dynamic shakes out, we'll be able to see the impact of competition versus COVID. Assuming that a significant chunk of the U.S. slowing growth rate or decline is due to competition, what can be done to recoup the momentum against the narrative, particularly of Calquence?

幾個問題。首先，關於因布魯維卡。隨著我們進入 2022 年和 COVID 動態的變化，我們將能夠看到競爭與 COVID 的影響。假設美國經濟增長放緩或下降的很大一部分是由於競爭，那麼可以做些什麼來彌補這種說法，尤其是 Calquence 的勢頭？

And then second, in terms of your aesthetics business, you terminated your contract with Medytox in your liquid formulation. There are competitive products coming to market as well as increasing price competition. How much of that is concerned -- or is your franchise and the breadth of the portfolio enough to minimize any impact of novel formulations?

其次，就您的美容業務而言，您終止了與 Medytox 的液體配方合同。有競爭力的產品進入市場，價格競爭也越來越激烈。其中有多少是值得關注的——或者您的特許經營權和產品組合的廣度是否足以將新配方的任何影響降至最低？

Yes. It's Jeff. So thanks. And you're right that we still have the continuing lingering effect with COVID, and Rob addressed that in his comments. So we still see the market versus '19 levels down about 10% and even marginally down from 2020 in Q4. So we anticipate that, that will moderate go forward. And then we're left to manage the competitive impact. So we are seeing competitive BTKs have some impact on Imbruvica, but we're also seeing the competitive impact from our own Venclexta. So we have to start to think about looking at the combination of the AbbVie position, which is still very, very strong.

是的。是傑夫。那謝謝啦。你說得對，我們仍然對 COVID 產生持續揮之不去的影響，Rob 在他的評論中談到了這一點。因此，我們仍然看到市場相對於 19 年的水平下降了約 10%，甚至比第四季度的 2020 年略有下降。因此，我們預計，這將適度向前發展。然後我們要管理競爭影響。因此，我們看到有競爭力的 BTK 對 Imbruvica 產生了一些影響，但我們也看到了我們自己的 Venclexta 的競爭影響。所以我們必須開始考慮看組合的 AbbVie 位置，它仍然非常非常強大。

To give you some sense in second line, we have 45% share of the market, and it's even higher in third line, and it's in the 30s for frontline. So we have to continue, which is our strategy, to highlight where we have a lot of distinction, which is the strength of our data across every comparator in CLL, the overall survival benefit and then also bring the strength of our overall portfolio. So that's how we plan to mitigate it. As Rob mentioned, we see market recovery offset by some share pressure on Imbruvica, mitigated by positive ven impact. So that's how we see the market develop as we go into 2022.

在二線，我們有 45% 的市場份額，三線甚至更高，前線是 30 多歲。所以我們必須繼續，這是我們的戰略，突出我們有很多區別的地方，這是我們在 CLL 中每個比較器的數據強度，總體生存收益，然後也帶來了我們整體投資組合的實力。這就是我們計劃減輕它的方式。正如 Rob 所提到的，我們認為市場復甦被 Imbruvica 的一些股票壓力所抵消，而正面的 ven 影響則減輕了這種壓力。這就是我們在進入 2022 年時看到市場發展的方式。

We also are seeing some pricing pressure in some select segments that are also contributing to the share loss for Imbruvica. And obviously, we -- as much as we can, we keep the pricing discipline in the market moving forward. So I hope that context helps.

我們還看到一些特定細分市場的定價壓力也導致了 Imbruvica 的份額損失。顯然，我們盡可能地保持市場的定價紀律向前發展。所以我希望上下文有所幫助。

This is Rick. I'll cover the aesthetics questions for you. Certainly, as you look at Botox, both here in the U.S. and internationally, it competes today against a significant number of competitive alternatives that are available. I think it's a pretty impressive position that Botox has in the market. When you look at the brand equity that it has, when you look at the confidence that injectors have in using the product, they tend to describe it as the most forgiving of all the toxins that they have experience with.

這是瑞克。我將為您解決美學問題。當然，當您查看肉毒桿菌毒素時，無論是在美國還是在國際上，它今天都在與大量可用的競爭性替代品競爭。我認為肉毒桿菌在市場上的地位令人印象深刻。當您查看它擁有的品牌資產時，當您查看注射器對使用該產品的信心時，他們傾向於將其描述為他們所體驗過的所有毒素中最寬容的。

And then there's obviously a fairly significant customer loyalty aspect to Botox with the loyalty programs, and Allergan has a very significant loyalty program that offers patients incentives to be able to use the product and to go back and get repeat procedures. Having said all of that, we feel confident in the position that we have competitively against the competitive alternatives that we see out there and those that we see coming.

然後，通過忠誠度計劃，肉毒桿菌毒素顯然具有相當重要的客戶忠誠度方面，艾爾建 (Allergan) 有一個非常重要的忠誠度計劃，為患者提供激勵，讓他們能夠使用該產品並返回並獲得重複程序。說了這麼多，我們對我們在與我們看到的競爭性替代品和我們看到的未來的競爭性替代品中的競爭地位充滿信心。

We have a very active R&D effort in the aesthetics R&D group now that's looking at next-generation toxins. Two in particular that we highlighted in the comments earlier are we had a short-acting toxin that's in development that's progressing very nicely, and we have a true long-acting toxin that's in development as well. And we believe that those will help grow the market.

現在，我們在美學研發小組中進行了非常積極的研發工作，正在研究下一代毒素。我們在前面的評論中特別強調了兩個特別是我們有一種正在開發中的短效毒素，並且進展非常順利，我們還有一種真正的長效毒素也在開發中。我們相信這些將有助於擴大市場。

But if I look at the market now, obviously, we've seen significant acceleration in the market since we've activated many of the strategies that we put in place after acquiring Allergan. But if I look at our overall share, overall share has stayed very steady, in fact, might have ticked up 1 point in the latest set of data. So that tells you that we're not only growing the market very rapidly, but we're continuing to compete quite effectively against the alternatives that are out there.

但如果我現在看市場，很明顯，我們已經看到市場顯著加速，因為我們已經啟動了我們在收購 Allergan 後實施的許多策略。但是如果我看我們的整體份額，整體份額一直保持非常穩定，實際上在最新的一組數據中可能已經上升了 1 個百分點。所以這告訴你，我們不僅在非常迅速地發展市場，而且還在繼續與現有的替代品進行相當有效的競爭。

So I'm not overly concerned about what I see on the horizon. I think we have the opportunity to build the market even larger with some of the next-generation toxins that we're working on when we bring those to the marketplace. So I feel good about our position in toxins and in fillers as we move forward.

所以我並不過分擔心我在地平線上看到的東西。我認為，當我們將一些下一代毒素推向市場時，我們有機會利用我們正在研究的一些下一代毒素來建立更大的市場。因此，隨著我們前進，我對我們在毒素和填充劑方面的地位感到滿意。

Our next question comes from Vamil Divan from Mizuho Securities.

我們的下一個問題來自瑞穗證券的 Vamil Divan。

So a couple -- I always appreciate all the guidance you guys give, both near term and longer term. Just a couple of questions I have related to more of the longer-term guidance you've given. In the past, you had talked about your hem/onc franchise sort of in peak sales or sales, I guess, in 2025 of around $13 billion. When you updated some of your numbers earlier last month, I don't think you updated that one. So I'm just curious if you still think that, that's a reasonable sort of 2025 expectation.

所以一對夫婦——我總是感謝你們提供的所有指導，無論是短期還是長期。我有幾個問題與您提供的更多長期指導有關。過去，您曾談到您的 hem/onc 特許經營權的銷售高峰，我猜想，2025 年的銷售額約為 130 億美元。當你上個月早些時候更新你的一些數字時，我認為你沒有更新那個。所以我很好奇你是否仍然認為，這是對 2025 年的合理預期。

And then the other one is around Ubrelvy, where you've sort of stayed with this guidance of sort of more than $1 billion in peak sales. But you're already guiding to $800 million of sales just in this current year pretty early in the launch. So I'm just wondering if you can maybe give a little better sense of how you're viewing sort of the longer-term opportunity for Ubrelvy. And maybe if you want to mention QULIPTA, although I know that's early, but at least for Ubrelvy, if you think there's significant upside to that $1 billion number you've mentioned before.

然後另一個是在 Ubrelvy 附近，在那裡你一直在接受超過 10 億美元的峰值銷售額的指導。但是，就在今年剛剛發布的早期，您已經指導了 8 億美元的銷售額。所以我只是想知道你是否可以更好地了解你如何看待 Ubrelvy 的長期機會。也許如果你想提到 QULIPTA，雖然我知道這還為時過早，但至少對於 Ubrelvy，如果你認為你之前提到的 10 億美元的數字有很大的上升空間。

This is Rick. So I'll cover the first one, and then I'm going to have Jeff cover the Ubrelvy question that you've asked. So it's a good question. Obviously, the hem/onc market, in the areas that we participate in, in particular, I would say, CLL, has changed over the last several years. I think one of the -- certainly, one of the things that was not ever anticipated in that guidance was the impact that COVID would have on the market and the reduction that we saw in the number of new patients, which was quite sizable and obviously wasn't contemplated in it. And the second thing is we are seeing certainly more competitive pressure, both from price and some volume, than we anticipated in that time frame.

這是瑞克。因此，我將介紹第一個問題，然後讓 Jeff 介紹您提出的 Ubrelvy 問題。所以這是一個很好的問題。顯然，在我們參與的領域，特別是 CLL，hem/onc 市場在過去幾年中發生了變化。我認為其中之一——當然，該指南中從未預料到的一件事是 COVID 將對市場產生的影響以及我們看到的新患者數量的減少，這是相當可觀且明顯的沒有考慮到它。第二件事是，我們從價格和一些數量上看到的競爭壓力肯定比我們在那個時間範圍內的預期要大。

Having said all of that and -- well, I'd say a third item is, certainly, Venclexta is performing well as well. And I'd say it's tended to exceed some of our expectations, at least at this point, within the launch trajectory of the brand. So all of those have factors in what we're describing here.

說了這麼多，我想說第三個項目當然是 Venclexta 的表現也很好。而且我想說它往往超出了我們的一些預期，至少在這一點上，在品牌的發布軌跡中。所以所有這些都有我們在這裡描述的因素。

I'd also say we have done a nice job of building out our hem/onc portfolio from an R&D standpoint. When I look at some of those assets that I described in my opening comments, I think they're going to have a very significant opportunity. As an example, one that I didn't mention there would be Venclexta and the t(11;14) multiple myeloma population. That could be a very significant opportunity. We feel good about that. We should get a readout on that. And we think that could be a significant contributor to both improvement in patient therapy, but also a significant improvement in the overall revenue in the franchise. And then you have things like navitoclax and epcoritamab and 383, those are all significant opportunities to be able to drive growth. So I still feel confident in the overall ability for us to grow our hem/onc franchise.

我還要說，從研發的角度來看，我們在構建我們的 hem/onc 產品組合方面做得很好。當我查看我在開場評論中描述的一些資產時，我認為它們將有一個非常重要的機會。例如，我沒有提到的一個是 Venclexta 和 t(11;14) 多發性骨髓瘤人群。這可能是一個非常重要的機會。我們對此感覺良好。我們應該得到一個讀數。我們認為這可能是改善患者治療的重要因素，也是特許經營權整體收入的顯著改善。然後你有像 navitoclax 和 epcoritamab 和 383 這樣的東西，這些都是能夠推動增長的重要機會。所以我仍然對我們發展 hem/onc 特許經營權的整體能力充滿信心。

Having said that, I would say Imbruvica is under more pressure than we anticipated when we put that guidance out. At that point, we didn't even contemplate follow-on BTKs in any meaningful way. But we do see more competitive pressure there. But overall, I'd say I still feel very confident in our ability to be able to grow that, that it will be a growth franchise for the company over the long term.

話雖如此，我想說 Imbruvica 在發布該指南時承受的壓力比我們預期的要大。那時，我們甚至沒有以任何有意義的方式考慮後續的 BTK。但我們確實在那裡看到了更大的競爭壓力。但總的來說，我想說我仍然對我們能夠實現增長的能力充滿信心，這將是公司長期增長的特許經營權。

It's Jeff. So just to answer your question on Ubrelvy in the overall market. Certainly, we're very pleased, as I mentioned in my remarks, over the momentum on Ubrelvy. We continue to lead in that acute space. And the early results for QULIPTA are also very strong. Now a lot of it is going to depend on how that CGRP market develops. So if you think about it in this way, and this is how we think about it is, it's about -- in terms of new patient capture for the total Ubrelvy market, where we also compete with another player from Biohaven, it's about 18% to 19% of the market. And the market is also with the expanded triptan market, of course.

是傑夫。所以只是為了回答你在整個市場上關於 Ubrelvy 的問題。當然，正如我在講話中提到的，我們對 Ubrelvy 的發展勢頭感到非常高興。我們繼續在這個緊迫的領域處於領先地位。 QULIPTA 的早期結果也非常強勁。現在，其中很大一部分將取決於 CGRP 市場的發展方式。因此，如果您以這種方式考慮它，這就是我們的想法，它是關於 - 就整個 Ubrelvy 市場的新患者捕獲而言，我們還與 Biohaven 的另一家參與者競爭，大約是 18%佔市場的 19%。當然，市場也與擴大的曲坦市場有關。

So if you look at that, the payers certainly like you to step through one or more triptans. When you look at the population that may not be eligible for a triptan or fails a triptan, the estimates are typically up to 30% to 35%. And so the market has potential room to sort of double into that epidemiology. So you can kind of run the numbers there.

因此，如果您看一下，付款人肯定希望您逐步使用一種或多種曲坦類藥物。當您查看可能沒有資格使用曲坦或未使用曲坦的人群時，估計值通常高達 30% 到 35%。因此，市場有可能在這種流行病學中翻倍。所以你可以在那裡計算數字。

I mean we often get the question, is it over $1 billion? Is it closer to $1 billion? Or is it closer to a higher number? But nonetheless, we're pleased. Certainly, it's exceeded our expectations so far, and QULIPTA has as well. So I think there's more room for the market to run, but we'll have to see. I mean there are payer pressures in the market, as I mentioned, in terms of the step-through therapy.

我的意思是我們經常會遇到這樣的問題，是否超過 10 億美元？是否接近 10 億美元？還是更接近更高的數字？但儘管如此，我們很高興。當然，到目前為止，它已經超出了我們的預期，QULIPTA 也是如此。所以我認為市場還有更多的運行空間，但我們必須拭目以待。我的意思是，正如我所提到的，就逐步治療而言，市場上存在付款人壓力。

Our next question comes from Steve Scala from Cowen.

我們的下一個問題來自 Cowen 的 Steve Scala。

I have a couple of questions. At a high level, I struggle to understand why 2022 won't be a stronger year than the guide on the earnings line. Skyrizi and Botox are doing phenomenally. Rinvoq is holding its own. Humira will still be exclusive in the U.S. for the whole year and should be at peak profitability and the pandemic, less an obstacle. So why won't 2022 look more like or even better than 2021 in terms of earnings power?

我有一些問題。在較高的層面上，我很難理解為什麼 2022 年不會比收益線上的指引更強勁。 Skyrizi 和 Botox 的表現非常出色。 Rinvoq 擁有自己的。 Humira 全年仍將在美國獨家銷售，並且應該處於盈利能力和大流行的高峰，而不是障礙。那麼，在盈利能力方面，為什麼 2022 年看起來不會比 2021 年更像甚至更好呢？

And secondly, there was no mention of the CF program even in the upcoming milestones. Any thoughts on the timing of the triplet data? In the past, I would describe AbbVie confidence as being no more than moderate. Has it changed one way or the other?

其次，即使在即將到來的里程碑中，也沒有提到 CF 計劃。關於三元組數據的時間安排有什麼想法嗎？過去，我將 AbbVie 的信心描述為不超過適度。它改變了一種方式或另一種方式嗎？

This is Rick. Maybe Rob and I will tag team your first question, and then Michael will cover your second question. I think if I look at 2022 and I look at our overall performance coming off of a strong year in 2021, it's pretty impressive performance. When I look at the EPS growth, certainly, do we have an opportunity to drive it harder? I can tell you, every year, we endeavor to drive it as hard as we can drive it. And when I look at all of the businesses individually and I look at their ability to be able to perform, I'm extremely confident in the trajectory that we have going forward.

這是瑞克。也許 Rob 和我會標記你的第一個問題，然後 Michael 會回答你的第二個問題。我認為，如果我回顧 2022 年，並看看我們在 2021 年強勁的一年之後的整體表現，那將是非常令人印象深刻的表現。當我看到每股收益增長時，當然，我們有機會更努力地推動它嗎？我可以告訴你，每年，我們都會盡我們所能努力推動它。當我單獨查看所有業務並查看它們的執行能力時，我對我們前進的軌跡非常有信心。

Specifically, we're assuming, as an example, in HCV -- that there's still a COVID impact in HCV. So I wouldn't say the pandemic is completely gone in 2022. And -- but I'd say overall, the brands are performing well. We're investing in the business to ensure that we continue to be able to drive long-term performance. And so certainly, that obviously drives some expectations around what the EPS growth will be year-over-year. I don't know, Rob, anything you'd like to add?

具體來說，我們假設，例如，在 HCV 中——HCV 中仍然存在 COVID 影響。所以我不會說大流行在 2022 年完全消失。而且——但我想說的是，總體而言，這些品牌表現良好。我們正在對該業務進行投資，以確保我們能夠繼續推動長期業績。當然，這顯然推動了對每股收益同比增長的一些預期。我不知道，Rob，你有什麼要補充的嗎？

I mean I think it's a good point and that we are fully investing to support the long-term growth. If you think about -- we're launching -- AD, that's a new area for us. QULIPTA and Vuity, we're also going to fully invest there. Aesthetics, we've seen that -- the strength of the investment in aesthetics, the way we've been able to grow the market. So that's really important.

我的意思是我認為這是一個很好的觀點，我們正在全力投資以支持長期增長。如果您考慮 - 我們正在推出 - AD，那對我們來說是一個新領域。 QULIPTA 和 Vuity，我們也將在那裡進行全面投資。美學，我們已經看到了——美學投資的力量，我們能夠發展市場的方式。所以這真的很重要。

At the same time, we're expanding operating margin. We're exceeding our expectations for synergies. And so you're seeing us deliver another year of operating margin expansion. So I'd say we're top tier in operating margin, very healthy P&L profile.

與此同時，我們正在擴大營業利潤率。我們超出了我們對協同效應的期望。因此，您將看到我們又實現了一年的營業利潤率擴張。所以我想說我們在營業利潤率方面是一流的，損益表非常健康。

And then the other thing that you probably have to factor in here is that we've assumed half year Restasis as well. We don't really have visibility to the generic until we make an assumption every time we update guidance 6 months out. So that's something that as you look at year-over-year that you should figure into your comparisons. But overall, we're very pleased with delivering double-digit growth in earnings and seeing another year of very strong operating margin expansion while fully investing to support the growth of the business.

然後你可能需要考慮的另一件事是我們也假設了半年的恢復。直到每次我們在 6 個月後更新指南時做出假設，我們才能真正了解通用性。因此，當您逐年查看時，您應該在比較中考慮到這一點。但總體而言，我們很高興實現兩位數的收益增長，並看到又一年非常強勁的營業利潤率增長，同時全面投資以支持業務增長。

And this is Mike. I'll take the question on CF. I think it's important to keep in mind that this is a pre proof-of-concept program that doesn't contribute in any meaningful way to our long-term outlook and doesn't factor into our thinking about the long-term potential in the pipeline. And the way we have discussed it is consistent with that view. We've always said that it represents significant upside if it were to hit, but it's an early program.

這是邁克。我會回答關於 CF 的問題。我認為重要的是要記住，這是一個概念驗證程序，不會以任何有意義的方式對我們的長期前景做出貢獻，也不會影響我們對長期潛力的思考。管道。我們討論它的方式與這種觀點是一致的。我們一直說，如果它被擊中，它代表著巨大的上升空間，但這是一個早期的計劃。

With respect to the timing of the data, we continue to track towards the timing that we've described previously. We would expect to have data from the triple, sufficient to enable a go/no-go decision later on this quarter.

關於數據的時間安排，我們繼續跟踪我們之前描述的時間安排。我們預計將獲得來自三重奏的數據，足以在本季度晚些時候做出通過/不通過的決定。

Our next question comes from Tim Anderson with Wolfe Research.

我們的下一個問題來自 Wolfe Research 的 Tim Anderson。

A couple of questions. I'm guessing that as we move through 2022, investors are going to start to have some concerns about 2023 earnings, what the impact from Humira could be, and you talked about having more visibility on Humira contracting later this year. My question is, is it possible you'll actually give us 2023 earnings guidance sometime this year, like at Q3 results as an example?

幾個問題。我猜隨著我們進入 2022 年，投資者將開始對 2023 年的收益以及 Humira 的影響可能產生一些擔憂，並且您談到了今年晚些時候 Humira 合同的更多可見性。我的問題是，您是否有可能在今年某個時候向我們提供 2023 年的收益指導，例如以第三季度的業績為例？

And then my second question, just going back to CF data. You said in mid-November that you would actually have that data in-house by the end of the year. So here we are 4 weeks later, we haven't really seen anything. My question is, do you actually have that data in-house? Did you hit that time line of end of year. If not, what's going on? What changed in that short window?

然後我的第二個問題，回到 CF 數據。你在 11 月中旬說過，到年底你實際上會在內部擁有這些數據。所以我們在這裡是 4 週後，我們還沒有真正看到任何東西。我的問題是，你內部真的有這些數據嗎？你是否達到了年底的時間線。如果不是，那是怎麼回事？那個短暫的窗口發生了什麼變化？

Okay. Tim, this is Rick. I'll cover your first question. Mike can address the second one. We certainly are in a position now to be able to commit that we would give earnings guidance in the third quarter. I think clearly, we'll be able to give a better feel for what that erosion curve looks like. And could that ultimately end up being at least a pretty good perspective for us to be able to build off of what earnings guidance would look like? It might. I think if we're in a position where we can confidently provide that guidance, we would provide it.

好的。蒂姆，這是瑞克。我會回答你的第一個問題。邁克可以解決第二個問題。我們現在當然可以承諾我們將在第三季度提供收益指導。我清楚地認為，我們將能夠更好地了解侵蝕曲線的樣子。這最終是否會最終成為我們能夠建立在盈利指引的基礎上的一個很好的視角？它可能。我認為，如果我們能夠自信地提供指導，我們會提供指導。

But I certainly think we'll be in a position where we have very good visibility as to what that erosion curve will look like. And at that point, we can tighten it a bit and be able to provide a higher level of specificity. We understand it's an important issue for investors.

但我當然認為我們將處於一個非常清楚地了解侵蝕曲線會是什麼樣子的位置。到那時，我們可以稍微收緊一點，並能夠提供更高水平的特異性。我們知道這對投資者來說是一個重要問題。

As far as EPS is concerned, in 2023 -- we have said that we expect EPS to decline in 2023. So I don't think any investor is -- that would be a surprise to any investor. But obviously, it's important for us to be able to frame it as accurately as we can for the investment community and be able to provide direction around that. And at the point at which we think we can do that in a reliable way, we're committed to be able to do that.

就每股收益而言，在 2023 年——我們已經說過，我們預計每股收益將在 2023 年下降。所以我認為任何投資者都不會——這對任何投資者來說都是一個驚喜。但顯然，重要的是我們能夠為投資界盡可能準確地構建它並能夠圍繞它提供方向。在我們認為我們可以以可靠的方式做到這一點的時候，我們承諾能夠做到這一點。

So let's see how it plays out. And certainly, as we get to the third quarter call, that would be the position at -- the point at which, I think, we'd be in a position to be able to provide more clarity. Mike?

那麼讓我們看看它是如何發揮作用的。當然，當我們進入第三季度電話會議時，這將是我認為我們能夠提供更多清晰度的位置。麥克風？

So on CF, what we said towards the end of last year is that data would begin to come in-house around the end of the year, and we would have sufficient data to make a go/no-go in the first quarter. And we're still tracking to that overall time line.

所以在 CF 上，我們在去年年底說的是，數據將在年底左右開始進入內部，我們將有足夠的數據在第一季度做出決定。我們仍在跟踪整個時間線。

There were some challenges toward the end of the year, where a number of patients were expected from Australia, for example, and Australia shut down because of COVID and we had to shift that enrollment. So we perhaps have slightly less data than we would have hoped to have had at this point in the year. But again, we're still tracking to be able to make that go/no-go decision by the end of the year because it's important to keep in mind that these are short studies. And so once you get those patients in, you can turn the data around and make a decision pretty quickly. But the overall timing hasn't changed substantially from what we described at the end of last year.

到年底時遇到了一些挑戰，例如，預計會有一些來自澳大利亞的患者，而澳大利亞因 COVID 而關閉，我們不得不改變招生計劃。因此，我們的數據可能比我們希望在今年這個時候擁有的數據略少。但同樣，我們仍在跟踪是否能夠在今年年底之前做出決定，因為重要的是要記住這些都是短期研究。因此，一旦您讓這些患者參與進來，您就可以轉換數據並很快做出決定。但總體時間安排與我們去年年底所描述的相比沒有太大變化。

Our next question comes from Mohit Bansal from Wells Fargo.

我們的下一個問題來自富國銀行的 Mohit Bansal。

Congrats on the quarter. Maybe a question on Rinvoq and other oral competitions in -- competitors in IBD. Where do you see Rinvoq fitting versus other orals such as SNP inhibitor? I mean now they are more than -- there could be more than one. And KOLs, I mean, they kind of suggested some kind of induction with one drug and maintenance with other drug, a kind of treatment paradigm in IBD. Do you think it is even a possibility in any of these diseases?

祝賀本季度。也許是關於 Rinvoq 和其他口語比賽的問題——IBD 的競爭對手。您認為 Rinvoq 與其他口服藥物（如 SNP 抑製劑）相比在哪裡適合？我的意思是現在它們不止——可能不止一個。而 KOL，我的意思是，他們有點建議用一種藥物進行某種誘導，用另一種藥物進行維持，這是 IBD 中的一種治療範式。您認為這些疾病中的任何一種都有可能嗎？

I think if -- this is Mike. I'll take that question. If you look at the performance of Rinvoq in inflammatory bowel diseases, both in UC where we have the full data set and in Crohn's disease, where we have an important component of the induction data set, the performance across the board is very, very strong. Not only in terms of just overall response rates that are measured, but particularly when one looks at deeper measures of response, clinical remission, mucosal healing, major clinical response, which is the combination of remission and endoscopic improvement.

我想如果——這是邁克。我會回答這個問題。如果你看看 Rinvoq 在炎症性腸病中的表現，無論是在我們擁有完整數據集的 UC 中，還是在我們擁有誘導數據集的重要組成部分的克羅恩病中，整體表現都非常非常強.不僅在測量的整體反應率方面，而且特別是當人們觀察更深入的反應測量時，臨床緩解，粘膜癒合，主要臨床反應，即緩解和內窺鏡改善的組合。

And across the board, we're driving very high levels of disease control. And we think that feature of the drug, combined with the overall benefit risk, position us to compete very effectively against not only oral competitors but many competitors, all competitors in the field. When we look at those data, to our eye, given the limitations of cross-study comparisons, we see response rates that just aren't paralleled in the field. And so we think that there is a very real opportunity for Rinvoq, and our view of its role in IBD reflects that.

我們正在全面推動疾病控制的高水平。而且我們認為，該藥物的這一特點，再加上整體收益風險，使我們能夠非常有效地與口服競爭對手以及該領域的所有競爭對手進行競爭。當我們查看這些數據時，在我們看來，鑑於交叉研究比較的局限性，我們看到的響應率在該領域並不平行。因此，我們認為 Rinvoq 有一個非常真實的機會，我們對其在 IBD 中的作用的看法反映了這一點。

With respect to mixed induction and maintenance regimens, it's important to keep in mind that there are no data to support those sorts of regimens. All of the programs look at induction, followed by maintenance, which is usually a step-down in dose from the induction dose. And that's the data set that physicians will have.

關於混合誘導和維持方案，重要的是要記住沒有數據支持這些方案。所有的程序都著眼於誘導，然後是維持，這通常是從誘導劑量開始降低劑量。這就是醫生將擁有的數據集。

Now it's important to keep in mind that in the long term, patients often lose control and then they need to be reinduced with a new agent. And one of the very strong features of Rinvoq and quite frankly, Skyrizi also shares this characteristic, is it has very durable response. So it does maintain response for a very long period of time in the studies that we have continued to follow, including our long-term extensions from Phase II and our Phase III program. So we think those are also very strong attributes to the products.

現在重要的是要記住，從長遠來看，患者經常會失去控制，然後需要用新的藥物重新誘導。而 Rinvoq 的一個非常強大的特性，坦率地說，Skyrizi 也有這個特性，它具有非常持久的響應。因此，它確實在我們繼續遵循的研究中保持了很長一段時間的響應，包括我們從第二階段和第三階段計劃的長期擴展。所以我們認為這些也是產品非常強大的屬性。

Our next question comes from Gary Nachman from BMO Capital Markets.

我們的下一個問題來自 BMO Capital Markets 的 Gary Nachman。

Aesthetics has been a big source of upside in 2021. So I'm curious, did you see any real impact from Omicron in the fourth quarter? Do you see a tailwind maybe from that further recovery this year? Is that baked into the aesthetics guidance of $5.9 billion that you have for 2022? And you've talked about high single-digit long-term aesthetics guidance, but this year should be double digits. So should we be thinking more along the lines of double-digit growth maybe for the next few years if you're still investing a lot in that space?

美學一直是 2021 年上漲的一大來源。所以我很好奇，您是否看到 Omicron 在第四季度的任何真正影響？您是否認為今年的進一步復甦可能會帶來順風？這是否包含在您 2022 年 59 億美元的美學指導中？而且你已經談到了高個位數的長期美學指導，但今年應該是兩位數。那麼，如果您仍在該領域進行大量投資，我們是否應該更多地考慮未來幾年的兩位數增長？

And then just one other quick one on QULIPTA for the chronic migraine prevention indication. That data is coming soon sometime this quarter. So just talk about how meaningful you think that indication will be and how that's factored into the peak targets that you talked about.

然後是 QULIPTA 上的另一個快速預防慢性偏頭痛適應症。該數據即將在本季度的某個時候發布。因此，只需談談您認為該指示將有多大意義，以及如何將其納入您談到的峰值目標。

Gary, it's a good question on Omicron in aesthetics because it is something we track very carefully in every major geography around the world as well as by state here in the United States. And I will tell you that, at least as far as the U.S. is concerned, there has not been much of an impact on aesthetic volume, unlike what we saw when there was an actual shutdown. And obviously, you would think shutdown, you're going to see the volume go down. But I'd say here, we're seeing very little impact on the volume. So we have factored in that we don't expect a major disruption going forward. And I think the data would clearly support that, that's a reasonable position to take.

加里，這是一個關於 Omicron 美學的好問題，因為我們在世界各地的每個主要地理區域以及美國這裡的州都非常仔細地跟踪它。我會告訴你，至少就美國而言，這對審美量沒有太大影響，這與我們在實際停工時看到的情況不同。顯然，你會認為關機，你會看到音量下降。但我要在這裡說，我們看到對音量的影響很小。因此，我們已經考慮到我們預計未來不會出現重大中斷。我認為數據會清楚地支持這一點，這是一個合理的立場。

And as far as the business overall, I mean, I can tell you, we're very pleased with how the business is performing. I think that group is executing at a very high level. And certainly, the resourcing and the dedicated structure that we put in place, I think, are helping a lot in major geographies like the U.S. and China.

就整體業務而言，我的意思是，我可以告訴你，我們對業務的表現非常滿意。我認為該團隊的執行水平非常高。當然，我認為，我們建立的資源和專門的結構在美國和中國等主要地區有很大幫助。

We're obviously comfortable with the guide that we provided. It is an area that we're going to continue to invest in and continue to drive. And I think it's a market that, I think, is extremely attractive. And it's going to require both us to continue to execute and invest in it appropriately to grow the market, but also to build out more assets that meet patients' needs to be able to expand the market. And so we've almost doubled the R&D investment that we have in aesthetics since we took it over.

我們顯然對我們提供的指南感到滿意。這是我們將繼續投資並繼續推動的領域。我認為這是一個極具吸引力的市場。這將需要我們繼續執行和適當投資以擴大市場，還需要建立更多滿足患者需求的資產，從而能夠擴大市場。因此，自從我們接管它以來，我們在美學方面的研發投資幾乎翻了一番。

And we have a number of programs that, I think, are very exciting programs. Some of the biostimulatory and regenerative fillers that we're working on now, I think, could be exciting opportunities like tropoelastin. To be able to stimulate tropoelastin in patients using fillers is an exciting program that continues to advance. And so it's going to require both. It's something that we're absolutely committed to continue to drive. And I think this can be -- as we indicated in our comments, I think this can be a strong business for AbbVie over the long term. Jeff, do you want to cover QULIPTA?

我們有許多計劃，我認為這些計劃非常令人興奮。我認為，我們現在正在研究的一些生物刺激性和再生性填充劑可能是令人興奮的機會，例如原彈性蛋白。能夠使用填充劑刺激患者體內的原彈性蛋白是一項令人興奮的計劃，並且還在繼續推進。所以這兩者都需要。這是我們絕對致力於繼續推動的事情。而且我認為這可能 - 正如我們在評論中指出的那樣，我認為從長遠來看，這對 AbbVie 來說可能是一項強大的業務。傑夫，你想報導 QULIPTA 嗎？

Yes. Thanks, Gary, for your question on QULIPTA. It's an important new indication if we see -- when we see the data and it were to be approved. And I'll give you some perspective. Obviously, we've talked about how much we really like our portfolio of migraine. You got Botox on chronic with the injectors. Obviously, you have QULIPTA right now in episodic and, of course, Ubrelvy in acute. So the QULIPTA chronic gives us quite a bit of flexibility, and it's a nice catalyst. Even though episodic is a bigger market in terms of patients, obviously, chronic patients do consume a lot of medication.

是的。謝謝，加里，關於 QULIPTA 的問題。如果我們看到 - 當我們看到數據並且它被批准時，這是一個重要的新跡象。我會給你一些觀點。顯然，我們已經討論過我們有多喜歡我們的偏頭痛產品組合。你用注射器注射了肉毒桿菌毒素。顯然，你現在有 QULIPTA，當然，Ubrelvy 是急性的。所以 QULIPTA 慢性病給了我們相當多的靈活性，它是一個很好的催化劑。儘管就患者而言，間歇性是一個更大的市場，但顯然，慢性患者確實會消耗大量藥物。

Largely, if you think about the market structure, you've got injectors, meaning they inject Botox, or you have noninjectors. So to bring in the first oral that -- for people that don't choose to have a Botox-injectable practice, that's quite attractive. And we think it builds in our story over the strength of QULIPTA first-in-class designed specifically for these indications. So it's a very nice catalyst if it were to be approved. And so we're anxiously looking forward to that.

很大程度上，如果你考慮市場結構，你有註射器，這意味著他們注射了肉毒桿菌毒素，或者你有非注射器。因此，引入第一個口服藥物——對於那些不選擇進行肉毒桿菌注射實踐的人來說，這非常有吸引力。我們認為它建立在我們的故事中，建立在專為這些適應症設計的一流 QULIPTA 的實力之上。因此，如果要獲得批准，這是一個非常好的催化劑。因此，我們焦急地期待著這一點。

The other thing I would note, which is further off, and it's obviously something that would have to play out through the studies in Mike's organization, was chronic migraine is so difficult that the potential for patients to have combination treatment, so in other words, a Botox Therapeutic plus a simple oral drug like QULIPTA, could bring this concept to that segment of the market called migraine freedom where you're really trying to get the headaches down to as low as possible. And so again, it's further off, but it shows you the flexibility that we have as we continue to build out QULIPTA across our migraine portfolio. So we're pretty excited about the potential for CM.

我要注意的另一件事，離得更遠，顯然必須通過邁克組織的研究來發揮作用，慢性偏頭痛是如此困難，以至於患者有可能接受聯合治療，換句話說，一種肉毒桿菌毒素治療藥物加上像 QULIPTA 這樣的簡單口服藥物，可以將這一概念帶入被稱為無偏頭痛的市場領域，在那裡你真的想把頭痛降到盡可能低的程度。同樣，它離我們更遠了，但它向您展示了我們在繼續在我們的偏頭痛產品組合中構建 QULIPTA 時所擁有的靈活性。所以我們對 CM 的潛力感到非常興奮。

Our next question is from Geoff Meacham from Bank of America.

我們的下一個問題來自美國銀行的 Geoff Meacham。

Just had a couple of quick ones for Rick or for Rob. The first one is when you look at your our modified 2025 guidance for Skyrizi and Rinvoq, were there any changes to your assumptions on duration of therapy or the pricing environment? I'm just thinking about the payer landscape with many more biosimilars coming up and what impact that could have on switching or price increases.

剛剛為 Rick 或 Rob 準備了幾個快速的。第一個是當您查看我們針對 Skyrizi 和 Rinvoq 修改後的 2025 年指南時，您對治療持續時間或定價環境的假設是否有任何變化？我只是在考慮即將出現更多生物仿製藥的支付方格局，以及這可能對轉換或價格上漲產生什麼影響。

And then the second question is on the BD front, we've obviously seen valuations come down quite a bit in SMID-cap biotech in the past 6 months. And I know you've usually talked about $2 billion earmarked for BD, but does the current environment make things like bringing new TAs or newer technologies in-house more attractive?

然後第二個問題是在 BD 方面，我們顯然已經看到過去 6 個月中 SMID-cap 生物技術的估值下降了很多。而且我知道您通常會談到 20 億美元的專項資金用於 BD，但當前的環境是否會使諸如引入新的 TA 或內部新技術這樣的事情更具吸引力？

Rob?

搶？

Yes, Geoff. So obviously, when we go through our long-range plan, we consider the various dynamics of the pricing environment. So we factor that into our 2025 guidance. I would not say that there's really been an assumption change for duration of therapy. But we did -- we certainly took into account the impact of label on RA, AD and SpA, but then that was offset by the stronger performance OUS as well as the stronger IBD data that we saw for Rinvoq and just the overall performance of Skyrizi in psoriasis. It was all factored into that updated guidance, but we did not make an assumption change for duration of therapy, and we certainly factor in various pricing assumptions as we go through our long-range plan.

是的，傑夫。所以很明顯，當我們制定長期計劃時，我們會考慮定價環境的各種動態。因此，我們將其納入 2025 年指導。我不會說治療持續時間的假設確實發生了變化。但我們做到了——我們當然考慮了標籤對 RA、AD 和 SpA 的影響，但這被 OUS 更強的性能以及我們看到的 Rinvoq 更強的 IBD 數據以及 Skyrizi 的整體性能所抵消在牛皮癬中。這一切都被考慮到了更新的指導中，但我們沒有對治療持續時間做出假設改變，而且在我們制定長期計劃時，我們當然會考慮各種定價假設。

And maybe Mike and I will tag team #2. I mean, certainly, as we -- you've seen us pay down debt at a very significant pace. We're continuing to commit to pay down significant debt this year. And we'll certainly be in a position where we could do larger opportunities, if that was something that we desired and we thought it was the right kind of opportunity, as we move forward in '23 and '24. Certainly, the $2 billion that we've allocated has been sufficient to be able to cover the things that we're looking for. Mike has responsibility for business development so I think he's probably a little closer to the valuation question. Mike?

也許邁克和我會標記第 2 隊。我的意思是，當然，正如我們 - 你已經看到我們以非常顯著的速度償還債務。我們將繼續承諾在今年償還大量債務。我們肯定會處於一個可以創造更大機會的位置，如果這是我們想要的，並且我們認為這是正確的機會，我們將在 23 年和 24 年繼續前進。當然，我們分配的 20 億美元足以滿足我們正在尋找的東西。邁克負責業務發展，所以我認為他可能更接近估值問題。麥克風？

Well, what I would say is that valuations have certainly come down, and that brings opportunities into the focus that might previously been outside of that range of $2 billion a year that we had contemplated. And as Rick said, as we pay down debt, we have some more flexibility. But we're going to continue to look at BD in the same way that we always have, which is that it is an important component of adding innovation to our pipeline and needs to be coupled with our internal innovation.

好吧，我想說的是，估值肯定已經下降，這帶來了以前可能超出我們預期的每年 20 億美元範圍的機會。正如里克所說，當我們償還債務時，我們有更多的靈活性。但我們將繼續以與以往相同的方式看待 BD，即它是為我們的管道增加創新的重要組成部分，需要與我們的內部創新相結合。

So we're going to match what's out there. The innovation we see, the therapeutic areas that are most promising with what's going on in our early pipeline and use that to make sure that, overall, we have a very strong and very innovative pipeline. And you can see that, for example, in the way that we have built our hem/onc franchise, where we have a nice-blended, internally discovered and partnered programs from Venclexta and Imbruvica, obviously our lead programs, to the significant programs behind that, things like navitoclax, epcoritamab, 383 and now Teliso-V demonstrating extremely strong data in non-small cell lung cancer. So that's a blend of internal and external innovation.

所以我們要匹配那裡的東西。我們看到的創新，在我們早期管道中最有希望的治療領域，並使用它來確保總體而言，我們擁有一個非常強大和非常創新的管道。你可以看到，例如，在我們建立 hem/onc 特許經營權的方式中，我們有來自 Venclexta 和 Imbruvica 的很好的混合、內部發現和合作的項目，顯然是我們的主要項目，以及背後的重要項目諸如 navitoclax、epcoritamab、383 和現在的 Teliso-V 之類的東西在非小細胞肺癌中展示了極其強大的數據。所以這是內部和外部創新的結合。

And we're going to continue to look at areas in that same way. And it's principally going to be the fit for our overall situation, the strength of the innovation and that balance between internal and external innovation that we look at.

我們將繼續以同樣的方式看待領域。它主要是適合我們的整體情況，創新的力量以及我們所關注的內部和外部創新之間的平衡。

Our next question comes from Josh Schimmer from Evercore.

我們的下一個問題來自 Evercore 的 Josh Schimmer。

First, I'm a little surprised the contingent consideration adjustment is not higher considering your recently revised Skyrizi forecast. Am I not understanding that line correctly? Or should we be expecting a more meaningful revision in the first quarter?

首先，考慮到您最近修訂的 Skyrizi 預測，我對或有對價調整沒有更高感到有點驚訝。我沒有正確理解那條線嗎？還是我們應該期待在第一季度進行更有意義的修訂？

And then you mentioned a couple of times the novel biostimulatory dermal fillers you have in the aesthetics pipeline. Can you elaborate on how you expect those to differentiate versus the current offering and whether you expect those to expand the market for fillers?

然後您多次提到您在美學管道中擁有的新型生物刺激性真皮填充劑。您能否詳細說明您希望這些產品與當前產品有何不同，以及您是否希望這些產品能夠擴大填充物市場？

So Josh, this is Rob. I'll take your first question. So we did actually record in Q2 of last year additional accretion for higher sales forecast for Skyrizi. That was really tied to both our long-range plan as well as because it's a fair value measure. You have to take external forecast into account. And obviously, Street numbers have moved up as well. We came out with -- publicly with the updated guidance in December, but we already contemplated that in our contingent consideration accretion in Q2 of last year. So that's already accounted for.

喬什，這是羅伯。我會回答你的第一個問題。因此，我們確實在去年第二季度記錄了 Skyrizi 更高銷售預測的額外增長。這確實與我們的長期計劃相關，並且因為它是一種公允價值衡量標準。您必須考慮外部預測。很明顯，街道數量也增加了。我們在 12 月公開發布了更新後的指引，但我們已經在去年第二季度的或有考慮增加中考慮到了這一點。所以這已經佔了。

So on the biostimulatory fillers, I think the way to think about it, there are multiple programs, but I'll talk about 2 areas specifically. Certainly, one of the areas that you want to be able to look at is your ability to be able to stimulate collagen so that your own body can produce collagen to be able to provide support and filling in a specific area that you desire. And there are some products on the market today that provide that.

所以關於生物刺激性填充劑，我認為考慮它的方式，有多個程序，但我會具體談談兩個領域。當然，您希望能夠看到的領域之一是您能夠刺激膠原蛋白的能力，以便您自己的身體可以產生膠原蛋白，從而能夠提供支持和填充您想要的特定區域。今天市場上有一些產品可以提供這一點。

One of the negatives of those products is you don't get the immediate filling effect that you normally get with a filler, where you get physical filling immediately upon the procedure. You get a little bit of swelling that occurs. So for a very short period of time, you will get what looks to be filling, but then that swelling goes down. And then for a period of time, the patient has to wait in order for them to get the collagen impact, and that takes a significant period of time.

這些產品的缺點之一是您無法獲得通常使用填充物獲得的即時填充效果，您可以在手術後立即獲得物理填充。你會出現一點腫脹。所以在很短的時間內，你會得到看起來正在充盈的東西，但隨後腫脹就會消退。然後在一段時間內，患者必須等待才能獲得膠原蛋白的影響，這需要相當長的一段時間。

So we have a technology in-house that we acquired and we're further developing that combines both physical filling and collagen stimulation in one product. So you get the immediate filling effect of a normal filler. And then as that starts to resolve over time, you get the collagen impact that's building over that same period of time to provide long-term filling. So I would say that most of these technologies that we're working on are market expansion opportunities. So that's one example.

因此，我們擁有一項我們獲得的內部技術，並且我們正在進一步開發將物理填充和膠原蛋白刺激結合在一個產品中。因此，您可以獲得普通填充物的即時填充效果。然後隨著時間的推移開始解決，你會得到在同一時間段內建立的膠原蛋白影響，以提供長期填充。所以我想說，我們正在研究的大多數技術都是市場擴張的機會。這就是一個例子。

The second example would be one of the areas that is important for patients is what we describe as skin quality, the smoothness of your skin essentially. And one of the things that provides smoothness of your skin is the elasticity of the skin. So tropoelastin is an example of a product that we have in development that will allow the body to be able to produce more elastin.

第二個例子是對患者很重要的領域之一，即我們所說的皮膚質量，本質上是皮膚的光滑度。使您的皮膚光滑的一件事是皮膚的彈性。因此，原彈性蛋白是我們正在開發的產品的一個例子，它可以讓身體能夠產生更多的彈性蛋白。

So you can inject this product and it will provide, we believe, we have to prove this in the clinical studies, that would provide not only some level -- not a dramatic level of filling but an ability to be able to provide elastin formation along those areas and be able to smooth the skin out. That would clearly be a market expansion opportunity today. There really aren't fillers that do that. They can stretch the skin with the physical filling, but they don't really provide smoothing of the skin. And so those are 2 examples of what we're working on.

所以你可以注射這種產品，它會提供，我們相信，我們必須在臨床研究中證明這一點，這不僅會提供一定程度的——不是顯著水平的填充，而是能夠提供彈性蛋白形成的能力這些區域並能夠使皮膚光滑。這顯然是今天的市場擴張機會。真的沒有填充物可以做到這一點。它們可以用物理填充物拉伸皮膚，但它們並不能真正使皮膚光滑。這些是我們正在努力的兩個例子。

Our next question comes from Chris Raymond with Piper Sandler.

我們的下一個問題來自 Chris Raymond 和 Piper Sandler。

Just 2 questions. First, on the migraine franchise, noticed that you have a Phase III trial looking at QULIPTA in Botox in a combo therapy for migraine -- for chronic migraine prevention. Our doc checks indicate actually growing interest. Docs sort of highlight that as proactively -- as something they're interested in. I guess, was this trial in response to that feedback? Or maybe just talk about the rationale and how you're looking at combo in this space.

就2個問題。首先，在偏頭痛專營權方面，您注意到您有一項 III 期試驗，正在研究 Botox 中的 QULIPTA 用於偏頭痛的聯合治療——用於慢性偏頭痛的預防。我們的文檔檢查表明興趣確實在增長。文檔有點主動地強調了這一點——就像他們感興趣的東西一樣。我猜，這次試驗是為了回應那個反饋嗎？或者也許只是談論基本原理以及您如何看待這個領域的組合。

And then just a question on a drug that doesn't come up that you just launched, Vuity. Presbyopia represents a huge TAM. Maybe just talk about initial uptake trends. And what is it about this market, I guess, that you're seeing that you're not making a bigger deal out of this launch?

然後只是一個關於你剛剛推出的藥物的問題，Vuity。老花眼代表一個巨大的TAM。也許只是談談最初的吸收趨勢。我猜這個市場是怎麼回事，你看到你沒有從這次發布中賺到更大的錢？

So this is Mike. I'll start with the question on QULIPTA and Botox combo use, and then Jeff may want to add and take the second question. With respect to that combination, it really goes back to what Jeff said before, this concept of migraine freedom. Now if you think about chronic migraine, these are patients who have 15 or more migraine days a month. That's a migraine every other day, and these are debilitating attacks.

這就是邁克。我將從 QULIPTA 和 Botox 組合使用的問題開始，然後 Jeff 可能想要添加並回答第二個問題。關於這種組合，它真的可以追溯到傑夫之前所說的偏頭痛自由的概念。現在，如果您考慮慢性偏頭痛，這些患者每月有 15 天或更多偏頭痛天數。每隔一天就會發生一次偏頭痛，這些都是使人衰弱的攻擊。

So a substantial reduction in that is great. But what patients and physicians are really seeking is an elimination of the migraine so that they can be free to go across their daily lives -- to go about their daily lives. And given the options that are out there today to really get to that level in those most severely affected patients, combination therapy is an obvious place to go, particularly when it's complementary approaches that work through completely different mechanisms. And so you would expect their effects to be independent and additive.

因此，大幅減少這一點非常好。但患者和醫生真正尋求的是消除偏頭痛，這樣他們就可以自由地度過他們的日常生活——開始他們的日常生活。考慮到今天可以在那些受影響最嚴重的患者中真正達到這一水平的選擇，聯合治療是一個明顯的選擇，特別是當它是通過完全不同機制發揮作用的互補方法時。所以你會期望它們的影響是獨立的和相加的。

And where you have a treatment like Botox, it has a long track record, it's infrequently administered and has a long duration. So it's that thinking that led to that combination trial. And I do think we would also agree that there is significant interest in treating physicians around these approaches.

如果你有像肉毒桿菌毒素這樣的治療方法，它有很長的記錄，很少使用並且持續時間很長。所以正是這種想法導致了組合試驗。而且我確實認為我們也會同意圍繞這些方法治療醫生有很大的興趣。

Yes. Just to add to that, that's exactly right, is the -- it's so logical and there's so much unmet need, to Mike's point, in chronic migraine with half a month -- sometimes these migraines last for days. And so there's a lot of desperation. And when the thought leaders and the headache specialists see the impact of Botox and how simple QULIPTA is and how strong that is, they go right there. So I think we are encouraged, as Mike mentioned, to sort of see the outcome of those studies for migraine freedom. It would -- if it works, it would be a real advance for patients.

是的。補充一點，這是完全正確的，在邁克看來，這是非常合乎邏輯的，並且有很多未滿足的需求，在半個月的慢性偏頭痛中 - 有時這些偏頭痛會持續數天。所以有很多絕望。當思想領袖和頭痛專家看到肉毒桿菌毒素的影響以及 QULIPTA 的簡單性和強度時，他們就會去那裡。因此，正如邁克所提到的，我認為我們受到鼓勵，可以看到這些研究對偏頭痛自由的結果。它會——如果它有效，這對患者來說將是一個真正的進步。

And so on Vuity, you're right, we didn't comment on it on this meeting. We typically wouldn't comment on a product that's of this size. And I mean it's a very interesting product. I think it clearly has a unique fit in the market. I'll have -- I'll let Jeff talk a little bit about the total available market, what we see as far as the size of that market going forward. But the reason we didn't highlight it is, like I said, if we look at what we think peak sales will be here, it's not a product of the magnitude that we would typically highlight.

等等 Vuity，你說得對，我們沒有在這次會議上發表評論。我們通常不會評論這種尺寸的產品。我的意思是這是一個非常有趣的產品。我認為它顯然在市場上有獨特的契合度。我會 - 我會讓 Jeff 談談整個可用市場，以及我們對未來市場規模的看法。但是，就像我說的那樣，我們沒有強調它的原因是，如果我們看一下我們認為這裡會出現什麼銷售高峰，那並不是我們通常會強調的那種規模的產品。

Yes. And what we see is that there is excitement about Vuity. I mean it's different than the -- obviously, the market is basically over-the-counter or prescription eyeglasses or readers, right? So this is the first-ever product that basically is a drop or a reading drop, right? So when we start to break down the data and you take a really, really big market, tens and tens of millions of patients with presbyopia but we also largely see from the clinical study, it really works the best for moderate to severe younger people, not older people.

是的。我們看到的是，Vuity 令人興奮。我的意思是它不同於——顯然，市場基本上是非處方眼鏡或處方眼鏡或閱讀器，對吧？所以這是有史以來第一個基本上是水滴或閱讀水滴的產品，對吧？因此，當我們開始分解數據時，您會看到一個非常非常大的市場，數以千萬計的老花眼患者，但我們也主要從臨床研究中看到，它確實對中度至重度的年輕人最有效，不是老年人。

So as we basically make the cuts, it's still a substantial market size, but it's not as large as you might think if you just look at all the presbyopes that are better in the United States. But nonetheless, it's early days where we have a sales force that's calling on our optometrist, also ophthalmologists. What we see from the early results is significant interest. We haven't started our big consumer push, which will come later in this quarter.

因此，當我們基本上進行削減時，它仍然是一個可觀的市場規模，但它並沒有你想像的那麼大，如果你只看美國所有更好的老花眼。但儘管如此，我們還處於早期階段，我們的銷售團隊正在召集我們的驗光師和眼科醫生。我們從早期結果中看到的是極大的興趣。我們還沒有開始大力推動消費者，這將在本季度晚些時候推出。

It is an older glaucoma product that's been reformulated. So there's a little bit of learning from the ophthalmologists who really understand glaucoma products. But overall, the early results are it works as anticipated. It works quickly within 15 minutes. It lasts for 6 to 8 hours. And so again, when we look at the price point, it's not a reimbursed product. It's a cash pay product. We have, to Rick's point, fairly modest expectations, and we'll continue to watch the trajectory here over the next quarter or so.

它是一種較舊的青光眼產品，經過重新配製。所以有一點點向真正了解青光眼產品的眼科醫生學習。但總的來說，早期的結果是它按預期工作。它在 15 分鐘內快速生效。它持續6到8個小時。同樣，當我們查看價格點時，它不是報銷產品。這是一種現金支付產品。就 Rick 而言，我們有相當溫和的預期，我們將在下個季度左右繼續關注這裡的發展軌跡。

I think the big assumption that you have to look at here is what is the utilization per month that a patient would actually use it for. I mean, as an example, I keep bugging the guys that I have to go get a prescription for it. Now what do I want it for? When I go to a restaurant, I have trouble reading in low light. So I'll use it for that purpose. And so it's very difficult to come up with the frequency at which it will be used. If it's used at a high frequency, it will obviously be a bigger product. If it's used at a relatively low frequency, it will be a smaller product. So we'll have to see how it plays out.

我認為您必須在這裡查看的一個重要假設是患者每月實際使用它的利用率是多少。我的意思是，作為一個例子，我一直在煩擾那些我必須去為它開處方的人。現在我要它幹什麼？當我去餐館時，我在光線不足的情況下閱讀有困難。所以我會用它來達到這個目的。所以很難想出它的使用頻率。如果使用頻率高，顯然會是一個更大的產品。如果它的使用頻率相對較低，它將是一個較小的產品。所以我們必須看看它是如何發揮作用的。

Our final question comes from Matthew Harrison from Morgan Stanley.

我們的最後一個問題來自摩根士丹利的 Matthew Harrison。

I guess 2 for me, if I may. So first, on epco, could you just comment around your confidence around accelerated approval here in DLBCL and how you're thinking about that opportunity in the near term? And then on Vraylar, maybe just comment on what FDA conversations are ongoing there and how you're thinking about the potential for an AdCom or not.

如果可以的話，我猜對我來說是 2 個。那麼首先，關於 epco，您能否就您對 DLBCL 加速批准的信心發表評論，以及您如何看待短期內的這個機會？然後在 Vraylar 上，也許只是評論那裡正在進行的 FDA 對話以及您如何考慮 AdCom 的潛力。

So on epco -- we have a high degree of confidence in epco overall. It continues to deliver very strong results, high overall response rates, very deep responses, good complete response rates across a number of indications, DLBCL and follicular lymphoma both.

所以關於 epco——我們對 epco 整體有很高的信心。它繼續提供非常強大的結果、高總體反應率、非常深的反應、在許多適應症、DLBCL 和濾泡性淋巴瘤兩者中的良好完全反應率。

With respect to the confidence in accelerated approval for diffuse large B-cell lymphoma, when we look at the data, we think it clearly exceeds the benchmarks of available therapies in highly pretreated refractory patients. So we would think that accelerated approval should be supported by those data. We'll allow the data to continue to mature from the expansion cohorts and have our final regulatory discussions later on this year to set up that accelerated approval submission. So it certainly is in our planning, and we think it's very supportable based on the data.

關於加速批准瀰漫性大 B 細胞淋巴瘤的信心，當我們查看數據時，我們認為它明顯超過了高度預處理的難治性患者可用療法的基準。所以我們認為這些數據應該支持加速批准。我們將允許數據從擴展隊列中繼續成熟，並在今年晚些時候進行最終的監管討論，以建立加速批准提交。所以它肯定在我們的計劃中，我們認為根據數據它是非常可支持的。

With respect to confidence in Vraylar in MDD, we're confident in that. We've been confident. We were confident when we saw the data and looked at the strength of those data and looked at the relevant precedents for molecules that have achieved indications, not only in depression, broadly speaking, but in adjunctive treatment of major depressive disorder. We've completed all of the regulatory discussions that we need to have for the submission, and we're planning the submission shortly, as we described in my prepared remarks.

關於在 MDD 中對 Vraylar 的信心，我們對此充滿信心。我們一直很有信心。當我們看到數據並查看這些數據的強度並查看已取得適應症的分子的相關先例時，我們充滿信心，不僅在抑鬱症中，廣義上，而且在重度抑鬱症的輔助治療中。正如我們在準備好的評論中所述，我們已經完成了提交所需的所有監管討論，並且我們正在計劃盡快提交。

In terms of potential for an AdCom, it's really too early to comment on that. We typically start to have those conversations with the agency a few months into the review process. But based on the data and based on the precedence, it's not something that we would anticipate. However, if the agency were to have one, it wouldn't concern us either. We think the data package is very strong and would hold its own.

就 AdCom 的潛力而言，現在評論還為時過早。我們通常會在審查過程的幾個月後開始與該機構進行這些對話。但是根據數據和優先級，這不是我們所期望的。但是，如果該機構有一個，我們也不會擔心。我們認為數據包非常強大並且會擁有它自己。

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

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

Thank you. That concludes today's conference call. Thank you for your participation. You may disconnect at this time.

謝謝你。今天的電話會議到此結束。感謝您的參與。此時您可以斷開連接。