艾伯維 (ABBV) 2022 Q1 法說會逐字稿

Good morning, and thank you for standing by. Welcome to the AbbVie First Quarter 2022 Earnings Conference Call. (Operator Instructions) Today's conference is being recorded. If you have any objections, you may disconnect at this time. 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 2022 年第一季度收益電話會議。 （操作員說明）今天的會議正在錄製中。如果您有任何異議，您可以在此時斷開連接。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; Rob Michael, Vice Chairman, Finance and Commercial Operations and Chief Financial Officer; Jeff Stewart, Executive Vice President, Chief Commercial Officer; and Tom Hudson, Senior Vice President, R&D and Chief Scientific Officer. Joining us for the Q&A portion of the call are Carrie Strom, Senior Vice President and President, Global Allergan Aesthetics; Neil Gallagher, Vice President and Chief Medical Officer; and Roopal Thakkar, Vice President, Global Regulatory Affairs.

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； Rob Michael，財務和商業運營副主席兼首席財務官； Jeff Stewart，執行副總裁兼首席商務官；以及研發高級副總裁兼首席科學官 Tom Hudson。與我們一起參加電話問答環節的還有艾爾建全球美學高級副總裁兼總裁 Carrie Strom； Neil Gallagher，副總裁兼首席醫療官；以及全球監管事務副總裁 Roopal Thakkar。

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

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 GAAP 財務指標與我們今天的收益發布和監管文件中的可比 GAAP 財務指標相一致，可以在他們的網站上找到。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 briefly comment on our overall performance, then Jeff, Tom and Rob will review our first quarter business highlights, pipeline progress and financial results in more detail.

謝謝你，麗茲。大家早上好，感謝您今天加入我們。我將簡要評論我們的整體業績，然後 Jeff、Tom 和 Rob 將更詳細地回顧我們第一季度的業務亮點、管道進展和財務業績。

I'm pleased with the excellent start to 2022. It further reinforces our confidence in the long-term fundamentals of the business. We reported adjusted earnings per share of $3.16, exceeding our expectations. Total net revenue of more than $13.5 billion was up 5.4% on an operational basis, also above our expectations. These results demonstrate strong momentum across several key products and portfolios, including robust double-digit operational revenue growth from Skyrizi, Rinvoq, Neuroscience and Aesthetics.

我對 2022 年的良好開端感到高興。這進一步增強了我們對業務長期基本面的信心。我們報告的調整後每股收益為 3.16 美元，超出了我們的預期。在運營基礎上，總淨收入超過 135 億美元，增長 5.4%，也高於我們的預期。這些結果顯示了幾個關鍵產品和投資組合的強勁勢頭，包括來自 Skyrizi、Rinvoq、Neuroscience 和 Aesthetics 的強勁兩位數運營收入增長。

Skyrizi is performing exceptionally well. We are achieving impressive market share gains in psoriasis, which remains a significant market opportunity. Skyrizi's recent launch in psoriatic arthritis as well as the anticipated regulatory approval in Crohn's disease should also serve as important growth drivers over the long term.

Skyrizi 的表現非常出色。我們在銀屑病領域取得了令人矚目的市場份額增長，這仍然是一個重要的市場機會。 Skyrizi 最近推出的銀屑病關節炎以及克羅恩病的預期監管批准也應成為長期的重要增長動力。

Rinvoq is also contributing compelling sales growth. Subscription trends in RA have recently stabilized as we expected and we're making excellent progress repositioning the brand as the leading second-line agent based on the robust data generated across our broad development programs. The early launch trends for Rinvoq in both atopic dermatitis and psoriatic arthritis are highly encouraging, with commercial access and paid prescriptions expected to ramp significantly over the coming months. We anticipate that these 2 new indications, along with the recent U.S. approval in ulcerative colitis, should add substantial revenue growth for Rinvoq over the long term.

Rinvoq 也貢獻了引人注目的銷售增長。正如我們預期的那樣，RA 的訂閱趨勢最近已經穩定下來，並且我們正在根據我們廣泛的開發計劃產生的強大數據將品牌重新定位為領先的二線代理，取得了巨大的進展。 Rinvoq 在特應性皮炎和銀屑病關節炎方面的早期推出趨勢非常令人鼓舞，預計未來幾個月商業准入和付費處方將顯著增加。我們預計，這兩個新的適應症，以及美國最近批准的潰瘍性結腸炎，應該會在長期內為 Rinvoq 帶來可觀的收入增長。

Neuroscience remains an exciting opportunity for our company. Vraylar continues to have strong momentum across our currently approved indication and the pending regulatory approval in major depressive disorder represents a significant upside to current projections. In migraine, our portfolio of distinct therapies with Ubrelvy, Qulipta and Botox Therapeutic is demonstrating robust double-digit sales growth. With the migraine market anticipated to roughly double in size over the next several years, there is significant headroom for continued revenue growth with these compelling therapies.

神經科學對我們公司來說仍然是一個令人興奮的機會。 Vraylar 在我們目前批准的適應症中繼續保持強勁勢頭，並且正在等待監管部門批准的重度抑鬱症對目前的預測有很大的好處。在偏頭痛方面，我們與 Ubrelvy、Qulipta 和 Botox Therapeutic 的獨特療法組合顯示出強勁的兩位數銷售增長。預計未來幾年偏頭痛市場的規模將大約翻一番，這些引人注目的療法有很大的持續收入增長空間。

Aesthetics is once again exceeding expectations. The category continues to grow robust double digits, especially in toxins and fillers, where there is substantial opportunity for further market penetration. Our commercial team is executing at a high level with targeted promotion and enhanced digital services, including our Alle loyalty program driving strong market share performance across our major brands.

美學再次超出預期。該類別繼續保持兩位數的強勁增長，特別是在毒素和填充劑方面，它們有很大的進一步市場滲透機會。我們的商業團隊正在高水平執行有針對性的促銷和增強的數字服務，包括我們的 Alle 忠誠度計劃，推動我們主要品牌的強勁市場份額表現。

In summary, this is an exciting time for AbbVie, and I'm extremely pleased with the evolution and momentum of our diverse portfolio. We're making excellent progress with the launches of several new products and indications, which will collectively add meaningful revenue for AbbVie as commercial access ramps for each of these opportunities over the remainder of this year. We're off to another exceptional start, and our long-term growth prospects remain strong.

總之，這對 AbbVie 來說是一個激動人心的時刻，我對我們多元化產品組合的發展和勢頭感到非常高興。我們在推出幾款新產品和適應症方面取得了巨大進展，這將共同為艾伯維（AbbVie）增加可觀的收入，因為在今年剩餘時間內這些機會的商業准入坡道。我們迎來了另一個非凡的開端，我們的長期增長前景依然強勁。

I'd now like to take a brief moment to thank Mike Severino for his contributions to the success of AbbVie over the last 8 years. As you know, Mike has decided to leave AbbVie at the end of May to pursue another career opportunity, and we wish him all the best. I'd also like to take this opportunity to formally introduce to you Tom Hudson. Tom joined AbbVie back in 2016 as the Head of Discovery and Early Development. In 2018, Tom undertook responsibilities for AbbVie's entire discovery organization. Then in 2019, was promoted to the Head of AbbVie R&D and Chief Scientific Officer, where he assumed responsibility for all of AbbVie's R&D.

我現在想花一點時間感謝 Mike Severino 在過去 8 年中為 AbbVie 的成功所做的貢獻。如您所知，邁克已決定在 5 月底離開艾伯維，以尋求另一個職業機會，我們祝他一切順利。我也想藉此機會向大家正式介紹一下湯姆·哈德森。 Tom 於 2016 年加入 AbbVie，擔任發現和早期開發主管。 2018 年，Tom 負責 AbbVie 的整個發現組織。然後在 2019 年，晉升為艾伯維研發負責人兼首席科學官，負責艾伯維的所有研發工作。

Tom has an impressive background as a clinical scientist. His medical specialty is in clinical immunology and allergy. Tom played a critical role in the human genome project while working at both the Whitehead Institute and MIT, where Tom led the team that mapped the human genome. Tom was also instrumental in the International HapMap Project to refine the genetic architecture of the human genome. Tom went on to further lead the Ontario Institute for Cancer Research, which included discovery and translational cancer research with a clinical network of more than 1,000 investigators.

湯姆作為一名臨床科學家有著令人印象深刻的背景。他的醫學專長是臨床免疫學和過敏。湯姆在懷特黑德研究所和麻省理工學院工作期間，在人類基因組計劃中發揮了關鍵作用，湯姆領導了繪製人類基因組圖譜的團隊。湯姆還在國際 HapMap 項目中發揮了重要作用，以完善人類基因組的遺傳結構。湯姆繼續領導安大略癌症研究所，其中包括發現和轉化癌症研究，其臨床網絡由 1,000 多名研究人員組成。

Tom will be providing an update on our continued pipeline progress to you later in the call. But first, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff?

Tom 將在稍後的電話會議中向您提供有關我們持續管道進展的最新信息。但首先，我將把電話轉給 Jeff，以徵求對我們商業亮點的更多評論。傑夫?

Thank you, Rick. We continue to demonstrate strong commercial execution across our therapeutic portfolio. I'll start with Immunology, which delivered global revenues of more than $6.1 billion, reflecting growth of 8.1% on an operational basis. Humira global sales were approximately $4.7 billion, down 1.8% on an operational basis with low single-digit revenue growth in the U.S., offset by biosimilar competition across international markets, where revenues were down 17.9% operationally.

謝謝你，瑞克。我們繼續在我們的治療組合中展示強大的商業執行力。我將從 Immunology 開始，該公司的全球收入超過 61 億美元，在運營基礎上實現了 8.1% 的增長。 Humira 的全球銷售額約為 47 億美元，在運營基礎上下降 1.8%，美國的收入增長率較低，但被國際市場的生物仿製藥競爭所抵消，其運營收入下降了 17.9%。

Skyrizi global revenues were $940 million, reflecting positive momentum in both approved indications. In psoriasis, Skyrizi is demonstrating impressive market share gains globally. Skyrizi now accounts for approximately 23% of the total prescription share in the U.S. biologic market. Skyrizi's in-play psoriasis share, which includes both new and switching patients, also remains very, very strong and now reflects roughly 40% patient share in the U.S. and a clear #1 leadership position.

Skyrizi 全球收入為 9.4 億美元，反映了兩個獲批適應症的積極勢頭。在銀屑病方面，Skyrizi 在全球範圍內展示了令人印象深刻的市場份額增長。 Skyrizi 現在約占美國生物市場處方藥總份額的 23%。 Skyrizi 的銀屑病在場份額（包括新患者和轉換患者）也仍然非常非常強勁，現在反映了美國大約 40% 的患者份額和明確的第一領導地位。

Skyrizi is performing exceptionally well internationally, where we have now achieved approximately 10% psoriasis share across our top 12 markets as well as in-play share leadership in more than 20 key countries. While we were early in our launch in psoriatic arthritis, we are encouraged by the uptake in this indication. In the dermatology segment, Skyrizi has already achieved in-play patient share of more than 10% in the U.S.

Skyrizi 在國際上的表現非常出色，我們現在已經在我們的前 12 個市場中實現了約 10% 的銀屑病份額，並在 20 多個主要國家/地區佔據領先地位。雖然我們在銀屑病關節炎方面處於起步階段，但我們對這一適應症的接受感到鼓舞。在皮膚科領域， Skyrizi 已經在美國實現了超過 10% 的在場患者份額。

Internationally, Skyrizi PSA is now approved in 45 countries, with reimbursement expected to increase throughout the year. Importantly, we are also preparing for the launch of Skyrizi in Crohn's disease, which represents another important long-term growth driver with approval decisions anticipated this year.

在國際上，Skyrizi PSA 現已在 45 個國家獲得批准，預計全年報銷額將增加。重要的是，我們還準備在克羅恩病中推出 Skyrizi，這是另一個重要的長期增長動力，預計今年將做出批准決定。

Turning now to Rinvoq, which delivered global sales of $465 million, demonstrating continued strong growth. As anticipated, we have seen an impact on new patient starts following the label update and Rinvoq prescriptions have now stabilized in the U.S., with in-play market share currently 12% in RA. We expect growth in the second line plus RA setting going forward where our field force is now focused on leveraging compelling data from 2 important Phase III trials.

現在轉向 Rinvoq，它實現了 4.65 億美元的全球銷售額，展示了持續的強勁增長。正如預期的那樣，我們已經看到標籤更新後對新患者開始的影響，並且 Rinvoq 處方現已在美國穩定下來，目前在 RA 中的有效市場份額為 12%。我們預計二線加 RA 設置將繼續增長，我們的現場部隊現在專注於利用來自 2 個重要的 III 期試驗的令人信服的數據。

First, SELECT-CHOICE, which demonstrated Rinvoq's superiority versus ORENCIA across key efficacy parameters, including clinical remission in previously treated RA patients. And second, the open-label extension of SELECT-COMPARE which demonstrated that many RA patients with an inadequate response to Humira are able to achieve remission after switching to Rinvoq. Early feedback suggests this updated Rinvoq RA messaging is resonating very well with health care practitioners. Internationally, Rinvoq share continues to ramp in RA with a total market share of approximately 5.5% across key geographies.

首先是 SELECT-CHOICE，它證明了 Rinvoq 在關鍵療效參數方面優於 ORENCIA，包括先前治療的 RA 患者的臨床緩解。其次，SELECT-COMPARE 的開放標籤擴展表明，許多對 Humira 反應不足的 RA 患者在改用 Rinvoq 後能夠實現緩解。早期反饋表明，更新後的 Rinvoq RA 信息與醫療保健從業者產生了很好的共鳴。在國際上，Rinvoq 在 RA 的份額繼續上升，在主要地區的總市場份額約為 5.5%。

We are also making excellent progress with Rinvoq's newly launched indications, including atopic dermatitis, psoriatic arthritis and ulcerative colitis. Managed care access is expected to ramp strongly for each of these indications over the coming months. As we build access, initial prescriptions are covered by our bridge program. which provides free patients or free goods to patients until formulary coverage is established. As a reminder, the volume from our bridge program is not captured in third-party prescription data.

我們還在 Rinvoq 新推出的適應症方面取得了出色的進展，包括特應性皮炎、銀屑病關節炎和潰瘍性結腸炎。預計在未來幾個月內，這些適應症中的每一個都將獲得管理式醫療服務。在我們建立訪問權限時，我們的橋樑計劃涵蓋了初始處方。向患者提供免費患者或免費商品，直至建立處方集覆蓋範圍。提醒一下，我們的橋樑計劃的數量並未包含在第三方處方數據中。

I'll start with atopic dermatitis. We are seeing new patient starts accelerating as we build access. When you include prescriptions from our bridge program, Rinvoq's total in-play AD share is already in the mid-teens. So we are pleased with the early adoption and repeating prescribers. As an oral option that provides significant skin clearance and itch relief, we believe Rinvoq has a strong differentiated position in this highly underpenetrated AD market.

我將從特應性皮炎開始。隨著我們建立訪問權限，我們看到新患者開始加速。當您加入我們橋牌計劃的處方時，Rinvoq 的遊戲中廣告總份額已經在十幾歲左右。因此，我們對早期採用和重複開藥者感到滿意。作為一種提供顯著皮膚清除和止癢的口服選擇，我們相信 Rinvoq 在這個高度滲透的 AD 市場中具有強大的差異化地位。

In PSA, we are seeing a nice uptake in Rinvoq's in-play share, especially in the room segment, where the severity of joint or skin manifestations of the disease can vary significantly by patients. And importantly, we have also launched Skyrizi in the room PSA segment this quarter, giving us 2 very compelling therapies to address the wide range of PSA patient types, regardless of how their symptoms present.

在 PSA 中，我們看到 Rinvoq 在遊戲中的份額得到了很好的吸收，特別是在房間部分，疾病的關節或皮膚表現的嚴重程度可能因患者而異。重要的是，本季度我們還在房間 PSA 部門推出了 Skyrizi，為我們提供了 2 種非常引人注目的療法來解決各種 PSA 患者類型，無論他們的症狀如何。

We have also launched our first indication in the IBD segment, Rinvoq for ulcerative colitis, where we are seeing a significant long-term opportunity in the second-line plus setting. Nearly 50% of UC patients are currently on or have used TNF therapy, so the addressable patient population is substantial. Given the strong benefit risk in this indication, we believe Rinvoq will be a welcome therapeutic option for UC patients and physicians.

我們還在 IBD 領域推出了第一個適應症，即用於潰瘍性結腸炎的 Rinvoq，我們在二線加環境中看到了重要的長期機會。近 50% 的 UC 患者目前正在接受或已經使用 TNF 治療，因此可尋址的患者群體非常可觀。鑑於這一適應症的巨大獲益風險，我們相信 Rinvoq 將成為 UC 患者和醫生的受歡迎的治療選擇。

Turning now to Hematologic Oncology. Global revenues were more than $1.6 billion, down 0.6% on an operational basis. Imbruvica global revenues were approximately $1.2 billion, down 7.4%. There are 2 factors impacting our Imbruvica results. First, we are seeing greater market share erosion in new patient starts than originally anticipated from newer therapy, including other BTK inhibitors as well as our own Venclexta.

現在轉向血液腫瘤學。全球收入超過 16 億美元，在運營基礎上下降 0.6%。 Imbruvica 的全球收入約為 12 億美元，下降 7.4%。有兩個因素會影響我們的 Imbruvica 結果。首先，我們看到新患者開始市場份額的侵蝕比新療法最初預期的要大，包括其他 BTK 抑製劑以及我們自己的 Venclexta。

Second, we continue to see higher-than-expected COVID suppression on new patient starts in CLL, which as a treat-to-progression therapy, has impacted the total BTK treated patient market. Our guidance assumes a market recovery over the course of this year, but it's too early to determine exactly how this may play out given the continued impact from recent COVID variant.

其次，我們繼續看到 CLL 對新患者開始的 COVID 抑制高於預期，作為一種治療到進展的治療，已經影響了 BTK 治療的患者市場。我們的指導假設今年市場會復蘇，但鑑於最近 COVID 變種的持續影響，現在確定這可能會如何發展還為時過早。

Despite these dynamics, Imbruvica remains the market-leading therapy for total patients across CLL and several other major blood cancers. Based on the magnitude of clinical data and real-world evidence generated for Imbruvica, showing sustained disease control as well as overall patient survival, we are confident it will continue to be a meaningful product for AbbVie over the long term.

儘管存在這些動態，但 Imbruvica 仍然是 CLL 和其他幾種主要血癌患者的市場領先療法。基於為 Imbruvica 生成的大量臨床數據和真實世界證據，顯示持續的疾病控制以及患者的總體存活率，我們相信從長遠來看，它將繼續成為 AbbVie 的有意義的產品。

Venclexta, however, is helping to offset some of the headwinds facing Imbruvica. Global sales were $473 million, up 21.1% on an operational basis. In the U.S., Venclexta is the clear market share leader in frontline AML among patients who are ineligible for intensive induction chemotherapy and recently achieved leading new patient share in second line plus CLL. We are also seeing robust momentum internationally with strong performance across all approved indications.

然而，Venclexta 正在幫助抵消 Imbruvica 面臨的一些不利因素。全球銷售額為 4.73 億美元，按運營計算增長 21.1%。在美國，Venclexta 是不符合強化誘導化療資格的患者中一線 AML 市場份額明顯的領導者，最近在二線加 CLL 中取得了領先的新患者份額。我們還在國際上看到了強勁的勢頭，在所有批准的適應症中表現強勁。

Additionally, we continue to make excellent progress building out our hem/onc portfolio with several compelling late-stage assets, such as epcoritamab for B-cell malignancies, navitoclax for myelofibrosis and ABBV-383 for multiple myeloma, expected support -- expected to support sustainable long-term growth.

此外，我們繼續在構建我們的 hem/onc 產品組合方面取得出色進展，其中包括幾個引人注目的晚期資產，例如用於 B 細胞惡性腫瘤的 epcoritamab、用於骨髓纖維化的 navitoclax 和用於多發性骨髓瘤的 ABBV-383，預期支持 - 預計將支持可持續的長期增長。

Turning now to Neuroscience, where revenues were approximately $1.5 billion, up more than 20% on an operational basis, including robust double-digit growth from Vraylar, Botox Therapeutic and Ubrelvy. Ubrelvy is performing very well and continues to be the market-leading oral CGRP treatment for acute migraine, with sequential demand growth observed.

現在轉向神經科學，其收入約為 15 億美元，在運營基礎上增長超過 20%，其中包括來自 Vraylar、Botox Therapeutic 和 Ubrelvy 的強勁兩位數增長。 Ubrelvy 表現非常好，繼續成為市場領先的急性偏頭痛口服 CGRP 治療藥物，並觀察到需求連續增長。

Qulipta is also demonstrating exceptional uptake in migraine prevention, with recent total prescriptions performing ahead of comparable branded launches. Qulipta is now capturing nearly 25% on of the new-to-brand share in the U.S. preventative CGRP class when we consider both paid and bridge volume. We expect commercial access to continue to ramp strongly over the remainder of the year.

Qulipta 在偏頭痛預防方面的表現也非常出色，最近的總處方表現優於同類品牌的推出。當我們考慮付費和過橋量時，Qulipta 現在在美國預防性 CGRP 類別中佔據了近 25% 的新品牌份額。我們預計商業准入將在今年剩餘時間內繼續強勁增長。

Qulipta has also recently demonstrated positive results from a registration-enabling study for the preventative treatment of chronic migraine, which we plan to submit to the agency for potential expanded use in the U.S. as well as to support regulatory applications across the international markets. This indication, if approved, will provide added differentiation for Qulipta as the only oral CGRP therapy for the preventative treatment of both episodic and chronic migraine.

Qulipta 最近還展示了一項預防性治療慢性偏頭痛的註冊研究的積極結果，我們計劃將其提交給該機構，以在美國擴大使用，並支持國際市場的監管申請。如果獲得批准，這一適應症將為 Qulipta 作為預防性治療發作性和慢性偏頭痛的唯一口服 CGRP 療法提供額外的差異化。

In our other notable therapeutics, Eye Care revenues of $771 million were down 2.8% on an operational basis with recent generic competition for Restasis unfavorably impacting our results. Mavyret sales were $380 million, down 4.6% on an operational basis as treated patient volumes remain depressed compared to pre-COVID levels.

在我們其他值得注意的療法中，眼部護理業務收入為 7.71 億美元，在運營基礎上下降了 2.8%，最近對 Restasis 的仿製藥競爭對我們的業績產生了不利影響。 Mavyret 銷售額為 3.8 億美元，在運營基礎上下降 4.6%，因為與 COVID 之前的水平相比，治療的患者數量仍然低迷。

So overall, I'm extremely pleased with our execution across the therapeutic portfolio, including the progress we are making with recent new product launches. We remain on track to deliver strong revenue growth once again in 2022.

因此，總的來說，我對我們在整個治療組合中的執行感到非常滿意，包括我們在最近推出的新產品方面取得的進展。我們仍有望在 2022 年再次實現強勁的收入增長。

And with that, I'll turn the call over to Tom for additional comments on our R&D program. Tom?

有了這個，我將把電話轉給湯姆，以徵求對我們研發計劃的更多評論。湯姆?

Thank you, Jeff. I'll start with immunology. We recently received FDA approval for Rinvoq in ulcerative colitis, a disease where there continues to be a significant unmet need for therapies that can provide high response rates and durable remission. In our UC development program, Rinvoq demonstrated some of the highest rates of remission and endoscopic improvements seen in Phase III studies. Importantly, Rinvoq also provided durable responses sustained through 1 year of treatment. Given the strong benefit risk profile, we believe Rinvoq will be an important new medicine for patients. Our regulatory applications for Rinvoq in UC remain under review in Europe and Japan, with approval decisions expected in the second half of this year.

謝謝你，傑夫。我將從免疫學開始。我們最近獲得了 FDA 對 Rinvoq 治療潰瘍性結腸炎的批准，在這種疾病中，對於能夠提供高反應率和持久緩解的治療方法的需求仍然存在巨大的未滿足需求。在我們的 UC 開發計劃中，Rinvoq 展示了 III 期研究中出現的一些最高緩解率和內窺鏡改善率。重要的是，Rinvoq 還提供了持續 1 年治療的持久反應。鑑於強大的收益風險狀況，我們相信 Rinvoq 將成為患者的重要新藥。我們在歐洲和日本對 UC 的 Rinvoq 監管申請仍在審查中，預計將在今年下半年做出批准決定。

Also in the area of inflammatory bowel disease, we recently reported positive top line results from the second Phase III induction study for Rinvoq in Crohn's disease. Similar to results from the first induction trial, in this induction study, Rinvoq demonstrated a very strong impact on the disease as measured by clinical remission and endoscopic response. We expect to see results from the Phase III maintenance study later in the quarter with our regulatory submissions for Rinvoq in Crohn's disease expected in the third quarter and approval decisions anticipated in 2023.

同樣在炎症性腸病領域，我們最近報告了 Rinvoq 在克羅恩病中的第二階段 III 誘導研究的陽性頂線結果。與第一次誘導試驗的結果相似，在這項誘導研究中，通過臨床緩解和內窺鏡反應來衡量，Rinvoq 對疾病產生了非常強烈的影響。我們預計將在本季度晚些時候看到 III 期維護研究的結果，我們預計在第三季度提交 Rinvoq 治療克羅恩病的監管文件，並預計在 2023 年做出批准決定。

Rounding out Rinvoq's development programs in rheumatology, we also have regulatory applications under review in ankylosing spondylitis and nonradiographic axial SpA. We expect an FDA approval decision in the second quarter for AS and decisions in the fourth quarter for non-radiographic axial SpA.

完善 Rinvoq 在風濕病學方面的開發計劃，我們還在審查強直性脊柱炎和非放射軸性 SpA 的監管申請。我們預計 FDA 將在第二季度對 AS 做出批准決定，並在第四季度做出對非放射軸向 SpA 的決定。

Moving to Skyrizi, where in the quarter, we announced an update regarding our regulatory application for Crohn's disease in the U.S. Following an FDA request for additional information primarily related to the on-body injection device used for maintenance dosing, we provided additional data for the device from an ongoing real life use study, which showed that patients can safely and effectively use the on-body device to self-administer Skyrizi. After responding to the agency's request, we received a 3-month extension of our Skyrizi submission in Crohn's disease. We remain confident in a strong benefit risk profile for Skyrizi in Crohn's disease and we now expect a decision in June.

轉到 Skyrizi，在本季度，我們宣布了有關我們在美國克羅恩病監管申請的更新。在 FDA 要求提供主要與用於維持給藥的體內註射裝置相關的其他信息之後，我們為來自正在進行的現實生活使用研究的設備，該研究表明患者可以安全有效地使用身體上的設備來自我管理 Skyrizi。在響應該機構的要求後，我們收到了將 Skyrizi 提交的克羅恩病申請延期 3 個月。我們仍然對 Skyrizi 在克羅恩病中的強大收益風險狀況充滿信心，我們現在預計將在 6 月做出決定。

Moving now to our oncology portfolio, where we continue to make excellent progress across all stages of our heme and solid tumor pipeline. We recently announced positive top line results from the first expansion cohort of the Phase II study, evaluating epcoritamab in patients with aggressive B-cell lymphoma who have received at least 2 prior lines of therapy.

現在轉到我們的腫瘤學產品組合，我們繼續在血紅素和實體腫瘤管道的所有階段取得出色進展。我們最近宣布了來自 II 期研究的第一個擴展隊列的陽性頂線結果，評估了 epcoritamab 對已接受至少 2 條先前治療線的侵襲性 B 細胞淋巴瘤患者的療效。

Epcoritamab performed extremely well as a monotherapy in these heavily pretreated and high-risk patients, demonstrating an overall response rate of 63% with a median duration of response of 12 months. These results are particularly encouraging given that nearly 40% of patients had failed CAR-T therapy. We plan to discuss these results with regulatory agencies about the potential to support submission for accelerated approval in the second half of this year.

Epcoritama 作為單藥治療在這些經過大量預處理和高風險的患者中表現非常好，顯示總體反應率為 63%，中位反應持續時間為 12 個月。鑑於近 40% 的患者 CAR-T 治療失敗，這些結果尤其令人鼓舞。我們計劃與監管機構討論這些結果，討論支持在今年下半年提交加速批准的可能性。

We continue to make good progress with the indication expansion programs for Venclexta and remain on track to see results from the Phase III CANOVA trial in relapsed/refractory multiple myeloma patients with a t(11;14) mutation in the second half of this year. In our Venclexta MDS program, based on feedback from the FDA, we have recently modified our regulatory strategy and now intend to submit data from our ongoing Phase III program. Venclexta remains under Breakthrough Therapy Designation for MDS and we continue to have a high degree of enthusiasm for Venclexta in this indication. We expect data readout from the Phase III study and our regulatory submission for MDS in 2024.

我們繼續在 Venclexta 的適應症擴展計劃方面取得良好進展，並有望在今年下半年看到針對具有 t(11;14) 突變的複發/難治性多發性骨髓瘤患者的 III 期 CANOVA 試驗的結果。在我們的 Venclexta MDS 計劃中，根據 FDA 的反饋，我們最近修改了我們的監管策略，現在打算提交我們正在進行的 III 期計劃的數據。 Venclexta 仍處於 MDS 的突破性治療指定下，我們繼續對 Venclexta 在這一適應症方面充滿熱情。我們預計 III 期研究的數據讀出和我們在 2024 年提交的 MDS 監管文件。

In Neuroscience, the FDA recently accepted our application for Vraylar as an adjunctive treatment for major depressive disorder. Based on the strong benefit-risk profile demonstrated in our clinical program, we believe Vraylar will be an important new therapy in this patient population, and we look forward to bringing this new treatment option to patients suffering from major depressive disorders.

在神經科學領域，FDA 最近接受了我們將 Vraylar 作為重度抑鬱症輔助治療的申請。基於在我們的臨床項目中展示的強大的收益-風險特徵，我們相信 Vraylar 將成為這一患者群體的重要新療法，我們期待為患有重度抑鬱症的患者帶來這種新的治療選擇。

In the area of migraine, we recently reported positive top line results from a Phase III study evaluating Qulipta for the prevention of chronic migraine. Qulipta performed very well in this study with both doses meeting the primary and all secondary endpoints, demonstrating Qulipta's ability to significantly reduce migraine days for patients suffering from chronic migraine. This summer, we plan to submit our regulatory application to the FDA for Qulipta in chronic migraine and also plan to submit data from our Phase III studies in both chronic migraine and episodic migraine to support regulatory applications in markets outside the U.S.

在偏頭痛領域，我們最近報告了一項評估 Qulipta 預防慢性偏頭痛的 III 期研究的積極頂線結果。 Qulipta 在這項研究中表現非常好，兩種劑量都滿足主要和所有次要終點，證明 Qulipta 能夠顯著減少慢性偏頭痛患者的偏頭痛天數。今年夏天，我們計劃向 FDA 提交 Qulipta 治療慢性偏頭痛的監管申請，併計劃提交我們在慢性偏頭痛和發作性偏頭痛方面的 III 期研究數據，以支持美國以外市場的監管申請。

In our cystic fibrosis program, we recently completed an interim analysis of a Phase II proof-of-concept study evaluating our triple combination therapy. The results -- the efficacy results from this interim analysis did not meet our prespecified criteria for advancing this triple therapy in development. This study was designed with a 28-day run-in treatment period with a dual combination therapy containing our C1 corrector and potentiator followed by a 28-day treatment period with a triple combination, which included the addition of our C2 corrector, ABBV-119.

在我們的囊性纖維化項目中，我們最近完成了對評估我們的三聯療法的 II 期概念驗證研究的中期分析。結果——該中期分析的療效結果不符合我們在開發中推進這種三聯療法的預定標準。本研究設計為 28 天磨合治療期，採用包含我們的 C1 校正劑和增強劑的雙重聯合治療，然後是 28 天的三聯治療期，其中包括添加我們的 C2 校正劑 ABBV-119 .

This allowed us to independently assess the therapeutic potential of our C2 corrector. The results showed that the addition of 119 did not provide a meaningful improvement in FEV1 or reduction in sweat chloride concentration over our dual combination therapy. During the run-in treatment period, we were able to again assess the efficacy of our dual therapy, which performed well providing efficacy consistent with results for the existing dual combination therapy. So based on the performance of our dual therapy, we plan to continue our CF program.

這使我們能夠獨立評估我們的 C2 校正器的治療潛力。結果表明，與我們的雙重聯合治療相比，添加 119 並未顯著改善 FEV1 或降低汗液氯化物濃度。在磨合治療期間，我們能夠再次評估我們的雙重治療的療效，其表現良好，提供的療效與現有雙重聯合治療的結果一致。因此，根據我們雙重療法的表現，我們計劃繼續我們的 CF 計劃。

We have an additional C2 corrector, ABBV-576 in Phase I studies that we plan to advance into a new triple therapy with our existing C1 corrector and potentiator. 576 is structurally distinct from our previous C2 corrector 119 and has a better PK profile and provides higher drug exposure, which has the potential to deliver better efficacy. Our plan is to begin a Phase II study for this new triple combo by early next year.

我們在 I 期研究中有一個額外的 C2 校正劑 ABBV-576，我們計劃使用我們現有的 C1 校正劑和增強劑推進新的三聯療法。 576 在結構上與我們之前的 C2 校正劑 119 不同，具有更好的 PK 曲線並提供更高的藥物暴露，這有可能提供更好的療效。我們的計劃是在明年初開始對這個新的三聯組合進行 II 期研究。

And in Aesthetics, we recently began the Phase III program for our short-acting toxin in glabellar lines. This novel toxin is designed to provide rapid onset of action and a short duration of effect, which would lower the barrier for adoption for certain segment of consumers. We expect to see data from this program next year with regulatory applications also anticipated in 2023.

在美學方面，我們最近開始了我們在眉間線中的短效毒素的 III 期計劃。這種新型毒素旨在提供快速起效和短效作用，這將降低某些消費者採用的障礙。我們預計明年將看到該計劃的數據，預計監管申請也將在 2023 年進行。

So in summary, we've continued to make significant progress with our pipeline to start the year, and we look forward to many more data readouts, regulatory submissions and approvals throughout the remainder of 2022. With that, I'll turn the call over to Rob for additional comments on our first quarter performance and financial outlook. Rob?

總而言之，我們在今年開始的管道方面繼續取得重大進展，我們期待在 2022 年剩餘時間裡有更多的數據讀出、監管提交和批准。有了這個，我將把電話轉過來Rob 就我們的第一季度業績和財務前景發表更多評論。搶？

Thank you, Tom. AbbVie's first quarter results demonstrate the strength of our broad portfolio, including double-digit growth from Skyrizi, Rinvoq, Venclexta, Neuroscience and Aesthetics. We also continue to deliver strong P&L performance, with another quarter of robust operating margin expansion while fully funding the business for long-term growth.

謝謝你，湯姆。艾伯維第一季度的業績證明了我們廣泛的投資組合的實力，包括 Skyrizi、Rinvoq、Venclexta、Neuroscience 和 Aesthetics 的兩位數增長。我們還繼續提供強勁的損益表業績，營業利潤率又實現了強勁增長，同時為業務的長期增長提供了充分的資金。

We reported adjusted earnings per share of $3.16, reflecting growth of 9.3% compared to prior year and $0.04 above our guidance midpoint. This includes an $0.08 unfavorable impact of acquired IPR&D expense that was not factored into our original guidance. Total net revenues were more than $13.5 billion, up 5.4% on an operational basis, excluding a 1.3% unfavorable impact from foreign exchange. Net revenues came in above our guidance despite the entry of generic competition for Restasis.

我們報告調整後的每股收益為 3.16 美元，與去年相比增長 9.3%，比我們的指導中點高 0.04 美元。這包括我們最初的指導中未考慮到的收購 IPR&D 費用的 0.08 美元不利影響。總淨收入超過 135 億美元，在運營基礎上增長 5.4%，不包括外匯帶來的 1.3% 的不利影響。儘管 Restasis 進入仿製藥競爭，但淨收入仍高於我們的預期。

The adjusted operating margin ratio was 51.4% of sales, an improvement of 150 basis points versus the prior year. This includes adjusted gross margin of 84.5% of sales, adjusted R&D investment of 10.9% of sales, acquired IPR&D expense of 1.1% of sales, and adjusted SG&A expense of 21.1% of sales. Net interest expense was $539 million, and the adjusted tax rate was 12.1%.

調整後的營業利潤率為銷售額的 51.4%，比上年提高 150 個基點。這包括調整後毛利率佔銷售額的 84.5%、調整後的研發投入佔銷售額的 10.9%、獲得的 IPR&D 費用佔銷售額的 1.1%，調整後的 SG&A 費用佔銷售額的 21.1%。淨利息支出為 5.39 億美元，調整後稅率為 12.1%。

Turning to our financial outlook. We are updating our full year adjusted earnings per share guidance to include the $0.08 for acquired IPR&D expense that was incurred during the first quarter. As a result, we now expect full year adjusted earnings per share between $13.92 and $14.12. This earnings per share guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the first quarter.

轉向我們的財務前景。我們正在更新我們的全年調整後每股收益指引，以包括第一季度發生的 0.08 美元收購 IPR&D 費用。因此，我們現在預計全年調整後每股收益在 13.92 美元至 14.12 美元之間。該每股收益指引不包括對可能在第一季度之後發生的已收購 IPR&D 費用的估計。

We now expect net revenues of approximately $59.4 billion. At current rates, we expect foreign exchange to have a 1.4% unfavorable impact on full year sales growth. This revenue guidance includes updated Restasis sales of approximately $400 million.

我們現在預計淨收入約為 594 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 1.4% 的不利影響。該收入指導包括約 4 億美元的最新 Restasis 銷售額。

Moving to the P&L. We now expect adjusted gross margin of 84.5% of sales, adjusted SG&A expense of $12.5 billion and an adjusted operating margin ratio of 51.8% of sales.

轉到損益表。我們現在預計調整後的毛利率為銷售額的 84.5%，調整後的 SG&A 費用為 125 億美元，調整後的營業利潤率為銷售額的 51.8%。

Turning to the second quarter. We anticipate net revenues of approximately $14.6 billion. At current rates, we expect foreign exchange to have a 1.5% unfavorable impact on sales growth. We expect adjusted earnings per share between $3.38 and $3.42. This guidance does not include acquired IPR&D expense that may be incurred in the quarter.

轉入第二季。我們預計淨收入約為 146 億美元。按照目前的匯率，我們預計外匯將對銷售增長產生 1.5% 的不利影響。我們預計調整後的每股收益在 3.38 美元至 3.42 美元之間。本指南不包括本季度可能發生的收購 IPR&D 費用。

In closing, we are off to an excellent start to the year with strong performance across multiple areas. We are making significant progress with new product launches and the pipeline, underscoring our confidence in AbbVie's long-term growth outlook.

最後，我們以在多個領域的強勁表現迎來了一個良好的開端。我們在新產品發布和管道方面取得了重大進展，突顯了我們對艾伯維（AbbVie）長期增長前景的信心。

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

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, please.

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

Our first question comes from Mohit Bansal from Wells Fargo.

我們的第一個問題來自富國銀行的 Mohit Bansal。

And maybe to begin with on Imbruvica. So I mean, the script trends are down, and you mentioned that we are -- so for new starts, you are losing some share to the competition. When you think -- can you please characterize how much share you are losing? And do you think it will stabilize over time? And when you look at Imbruvica and Venclexta combined, do you think the franchise can grow going forward from here?

也許從 Imbruvica 開始。所以我的意思是，劇本趨勢下降了，你提到我們是 - 所以對於新的開始，你正在競爭中失去一些份額。當你想——你能描述一下你失去了多少份額嗎？你認為它會隨著時間的推移而穩定嗎？當你把 Imbruvica 和 Venclexta 結合起來看時，你認為這支球隊可以從這裡發展嗎？

Yes. Thank you for the question. So as I mentioned in my comments, we are seeing greater share erosion. Imbruvica continues to be the leading share in the later lines, although we have lost our frontline share position to Calquence. And obviously, Venclexta is also moving there. So we see a couple of things that are taking place. So we have that share erosion that's putting some pressure on the brand. And then clearly, we see the continued suppression of the market. So it's kind of like a double hit.

是的。感謝你的提問。因此，正如我在評論中提到的那樣，我們看到了更大的份額侵蝕。 Imbruvica 繼續在後期產品線中佔據領先地位，儘管我們的一線市場份額已輸給 Calquence。很明顯，Venclexta 也在搬到那裡。所以我們看到了一些正在發生的事情。因此，我們的份額侵蝕給品牌帶來了一些壓力。然後很明顯，我們看到了市場的持續壓制。所以這有點像雙重打擊。

if we think of our -- if we think of this over the short, mid and longer term, what I would say would be this. So in the short term, meaning this year, we projected the share decline, and that includes some stabilization, but we still think the brand is under some pressure from other BTKs and Venclexta. And basically, we have flat guidance this year. And some of that includes a recovery of the market back to sort of more normal levels and we'll have to see how that progresses over the year.

如果我們考慮我們的 - 如果我們在短期、中期和長期考慮這個，我會說的是這個。所以在短期內，也就是今年，我們預計份額會下降，其中包括一些穩定，但我們仍然認為該品牌受到其他 BTK 和 Venclexta 的壓力。基本上，我們今年的指導方針持平。其中一些包括市場恢復到更正常的水平，我們將不得不看看這一年的進展情況。

If I think more about the midterm, I think what's important context there is new patient starts essentially make up roughly 13% to 15% of Imbruvica. So it's got a very, very large installed base, about 85%, maybe a little bit more in terms of what that's going to happen. We're not seeing any changes in persistency or items like that. So we think that we have a very good sense of stability for the brand over time in terms of what this may mean. And so that's basically how we think about it.

如果我更多地考慮中期，我認為新患者開始的重要背景基本上構成了 Imbruvica 的大約 13% 到 15%。所以它有一個非常非常大的安裝基礎，大約 85%，就將要發生的事情而言，可能還要多一點。我們沒有看到持久性或類似項目的任何變化。因此，我們認為隨著時間的推移，我們對品牌有很好的穩定性，這可能意味著什麼。所以這基本上就是我們的想法。

To answer your other question, if you look at the combined share, AbbVie has quite a strong position. We have roughly 33% of total share in the front line and we have between 42% and 46% of second-line plus. So clearly, Venclexta is able to offset, as I commented in my remarks, some of those pressures. So it's very important for AbbVie. It's going to be a very big brand over the long term. In the short term here and midterm, the growth is going to be more challenged moving forward.

要回答您的另一個問題，如果您查看合併後的份額，艾伯維（AbbVie）擁有相當強大的地位。我們在一線擁有大約 33% 的總份額，在二線以上我們擁有 42% 到 46% 的份額。很明顯，正如我在評論中評論的那樣，Venclexta 能夠抵消其中的一些壓力。所以這對艾伯維來說非常重要。從長遠來看，這將是一個非常大的品牌。在短期和中期，增長將面臨更大的挑戰。

Our next question comes from Terence Flynn from Morgan Stanley.

我們的下一個問題來自摩根士丹利的 Terence Flynn。

I was just wondering, obviously, you guys have been speaking with payers about the Humira positioning for 2023. Are you willing to give us any update in terms of how you're thinking about that guidance figure that you put out a couple of years ago? Any change in thinking there? And then are you able to disclose the CR rate for the recent epcoritamab Phase II trial? Just wondering how that factors into the decision about whether to seek accelerated approval here.

我只是想知道，顯然，你們一直在與付款人討論 Humira 2023 年的定位。你們是否願意就幾年前發布的指導數據的看法向我們提供任何最新信息?那裡的想法有什麼變化嗎？然後你能透露最近 epcoritamab II 期試驗的 CR 率嗎？只是想知道這對是否在此處尋求加速批准的決定有何影響。

So Terence, this is Rick. I'll take the first question for you. And I'm probably going to answer a little broader because I think it is important. I understand the interest in trying to understand how to model 2023, it's obviously important to us to model 2023 as accurately as possible. And I think if you step back, obviously, contracting is one portion of a variable that will impact the speed at which biosimilars are able to adopt -- be adopted in the market. If you step back and look, there's probably 4 key variables that will impact what that adoption rate looks like.

特倫斯，這是瑞克。我會為你回答第一個問題。我可能會回答更廣泛的問題，因為我認為這很重要。我理解嘗試了解如何為 2023 建模的興趣，對我們來說，盡可能準確地建模 2023 顯然很重要。而且我認為，如果你退後一步，顯然，合同是影響生物仿製藥能夠採用速度的變量的一部分——被市場採用。如果你退後一步看，可能有 4 個關鍵變量會影響採用率。

One of them is obviously what will Humira's access be post biosimilars entering the marketplace. And this is the period where you would normally be doing the contracting around that. I think we'll do well in being able to be co-positioned versus biosimilars in the vast majority of covered lives here in the United States. But that process isn't done, and we're not in a position to be able to ultimately give you any further update until we're a little further along in that process.

其中之一顯然是 Humira 在生物仿製藥進入市場後的准入。這是你通常會圍繞它進行合同的時期。我認為我們能夠在美國絕大多數被覆蓋的生活中與生物仿製藥共同定位方面做得很好。但是這個過程還沒有完成，在我們在這個過程中走得更遠之前，我們無法最終為您提供任何進一步的更新。

The second variable that will impact what 2023 looks like is how will the biosimilars price? We don't know that. Obviously, we have seen how they price in markets outside the U.S., but there's no market exactly like the U.S. internationally. And so that's a variable. We're making some projections of what we believe that pricing will look like. But that's ultimately something we're going to have to see how it plays out.

影響 2023 年情況的第二個變量是生物仿製藥的價格如何？我們不知道。顯然，我們已經看到了它們在美國以外市場的定價方式，但在國際上沒有與美國完全一樣的市場。所以這是一個變量。我們正在對我們認為定價的樣子做出一些預測。但這最終是我們將不得不看看它是如何發揮作用的。

I'd say the third variable is how competitive will these biosimilars be. It's going to be -- by the summer of 2023, there's going to be a lot of biosimilars in the U.S. market, but they're not all the same. And how competitive will they be against what is Humira today? And what do the bulk of patients use as it relates to Humira. And what I mean by that is interchangeability and a number of other factors are going to play into the competitiveness of those biosimilars.

我想說第三個變量是這些生物仿製藥的競爭力。這將是——到 2023 年夏天，美國市場上將會有很多生物仿製藥，但它們並不完全相同。他們與今天的 Humira 相比有多大的競爭力？以及與修美樂相關的大部分患者使用什麼。我的意思是可互換性和許多其他因素將影響這些生物仿製藥的競爭力。

And I'd say the fourth variable, and it's not something that people think about that much, and that is the ability of a biosimilar to be able to supply the U.S. market. There's no market like the United States for Humira anywhere around the world. In the United States, it's significantly larger than any other market around the world. There are certainly biosimilar players that are like an AbbVie, and I would expect them to have manufacturing capacity. There are generic players that could have sufficient manufacturing capacity, and then there are very small companies.

我會說第四個變量，這不是人們想那麼多的東西，那就是生物仿製藥能夠供應美國市場的能力。 Humira 在世界任何地方都沒有像美國這樣的市場。在美國，它比世界上任何其他市場都要大得多。肯定有像艾伯維（AbbVie）這樣的生物仿製藥廠商，我希望他們具備製造能力。有可能有足夠製造能力的通用參與者，然後是非常小的公司。

But I think anybody, any payer that's going to want to convert in any significant way to a biosimilar, they're going to want confidence that they can have a reliability of supply of that biosimilar. And we've spent years building the network that we have. We have full redundancy of every aspect of the manufacturing process on Humira. And we've never had a problem supplying the U.S. market. So I think we can be viewed as kind of the gold standard.

但我認為任何人，任何想要以任何重要方式轉換為生物仿製藥的付款人，他們都會希望有信心相信他們可以可靠地供應這種生物仿製藥。我們花了數年時間建立我們擁有的網絡。我們對 Humira 製造過程的各個方面都有充分的冗餘。而且我們從來沒有遇到過供應美國市場的問題。所以我認為我們可以被視為一種黃金標準。

So those are the variables that are going to impact what this transition looks like. The guidance we've given so far is this 45%, plus or minus 10%. I think at this point, that's still the best information that we can provide. Later this year, I think some of these variables will be clearer to it. And we may be in a position to be able to provide some more information to investors, and we would do that.

因此，這些變量將影響這種轉變的樣子。到目前為止，我們給出的指導是 45%，正負 10%。我認為在這一點上，這仍然是我們可以提供的最佳信息。今年晚些時候，我認為其中一些變量會更清楚。我們可能能夠向投資者提供更多信息，我們會這樣做。

Some will not. Pricing will not be clear at that point. We're not going to know how they're going to price until we actually get into -- they actually get into the marketplace. So I think that's the way to think about these variables. Rob, anything you'd add?

有些不會。屆時定價將不清楚。在我們真正進入之前，我們不會知道他們將如何定價——他們真正進入市場。所以我認為這是考慮這些變量的方式。 Rob，你有什麼要補充的嗎？

Yes. So this is Rob. I would just add that we've been trying to give investors some directional guidance on how to think about '23 and beyond just for Humira, 45%, plus or minus 10%. We've talked about Aesthetics growing high single digits annually over the next decade. You can get a sense based on Jeff's response today and the way to think about Imbruvica, in terms of operating margin, I've talked about that pulling back to the 46% to 47% range with no cuts to investment because we're going to return to growth very quickly. So we're going to continue to invest in this business.

是的。所以這是羅布。我只想補充一點，我們一直在努力為投資者提供一些關於如何考慮 23 年及以後的方向性指導，僅適用於 Humira，45%，正負 10%。我們已經談到了美學在未來十年中每年都以高個位數增長。您可以根據 Jeff 今天的回應以及對 Imbruvica 的思考方式有所了解，就營業利潤率而言，我已經談到在不削減投資的情況下回落到 46% 到 47% 的範圍，因為我們要去迅速恢復增長。因此，我們將繼續投資於這項業務。

And as I look at Street consensus, I see modeling of cuts in SG&A not necessarily reflecting the appropriate operating margin levels. So it's something just to keep in mind. And then even -- we've talked about the tax rate growing 1 point per year on average. Obviously, you saw this year, it only grew 0.2 points. Other years, it may go higher. So we've tried to give the Street some ideas of the way to think about '23 model in advance of our formal guidance.

當我查看華爾街共識時，我發現 SG&A 削減的模型不一定反映適當的營業利潤率水平。因此，請記住這一點。然後甚至 - 我們已經談到稅率平均每年增長 1 個百分點。顯然，你看到今年，它只增長了 0.2 個百分點。其他年份，它可能會更高。因此，我們試圖在我們的正式指導之前給華爾街一些關於思考 '23 模型的方式的想法。

Okay. Number 2, Neil?

好的。 2號，尼爾？

This is Neil Gallagher. I'll take the question regarding epcoritamab. So we recently reported data from the expansion cohort of relapsed/refractory DLBCL patients. We reported an overall response rate of 63% with a median duration of response of 12 months. One thing that's really important to bear in mind is that this is a pretty refractory patient population with a median number of prior therapies of 3.5 in a range up to 11 at the upper end.

這是尼爾加拉格爾。我會回答關於 epcoritamab 的問題。因此，我們最近報告了來自複發/難治性 DLBCL 患者擴展隊列的數據。我們報告的總體反應率為 63%，中位反應持續時間為 12 個月。需要牢記的一件非常重要的事情是，這是一個相當難治的患者群體，先前治療的中位數為 3.5，最高可達 11 個。

And importantly, just under 40% of these patients have failed prior therapy with the CAR-T. Overall, the safety profile remains manageable with the vast majority of the cases of CRS at class effect with these agents being grade 1 and 2. To directly address your question, we are not yet ready to reveal additional detail about the data. They will be revealed at a forthcoming medical meeting. And in fact, I was just in contact with the team yesterday, and I know that they're working very diligently to get those data on a podium in a meeting in the very near future.

重要的是，這些患者中只有不到 40% 的 CAR-T 先前治療失敗。總體而言，安全狀況仍然可控，絕大多數 CRS 病例在類效應中，這些藥物為 1 級和 2 級。為了直接解決您的問題，我們還沒有準備好透露有關數據的更多細節。他們將在即將舉行的醫學會議上公佈。事實上，我昨天剛剛與團隊聯繫，我知道他們正在非常努力地工作，以便在不久的將來在一次會議上將這些數據放在講台上。

Our next question is from Tim Anderson from Wolfe Research.

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

This is Alice Nettleton on for Tim Anderson. A question on Rinvoq. Where could in-play market share in atopic eventually get in your view? And are you seeing any switching away from Dupixent at all?

這是蒂姆安德森的愛麗絲內特爾頓。關於 Rinvoq 的問題。在您看來，特應性病的實際市場份額最終會在哪裡？你有沒有看到任何從 Dupixent 的轉變？

Yes. Thank you for the question. I'll give you some context. I mentioned that we see roughly in the mid-teens now after about 3 months, which we're very pleased in and some more flavor on that. If you think about the HCPs and the doctors that prescribe in the U.S. now, you've got about 9,000. Those are the dermatologists and some allergists. There's about 3,000 of those physicians that are the big prescribers. They're very productive. Those 3,000 are the ones that are driving Skyrizi, for example, or other big brands in psoriasis.

是的。感謝你的提問。我會給你一些背景信息。我提到，大約 3 個月後，我們現在大致看到了 10 歲左右，我們對此感到非常高興，並且對此有了更多的了解。如果你想想現在在美國開處方的 HCP 和醫生，你有大約 9,000 名。那些是皮膚科醫生和一些過敏症專家。大約有 3,000 名醫生是大處方者。他們非常有生產力。例如，這 3,000 人是推動 Skyrizi 或其他銀屑病大品牌的動力。

So we see after just about 3 months, we see almost 1,000 doctors that have prescribed Rinvoq. And so that's driving that 15%. Some of it depends in terms of where the in-play share ends up, how many of the competitors come in. We're not really sure that baricitinib will come into the market. We'll have to see. We haven't seen much Pfizer activity yet. To give you some sort of international perspective, in the Canadian market, we're seeing where there's really just Dupi and Rinvoq at this point after a couple of quarters, we're seeing a 30% in-play share in Canada.

所以我們看到僅僅 3 個月後，我們看到近 1000 名醫生開了 Rinvoq。這推動了 15% 的增長。其中一些取決於遊戲中的份額最終在哪裡，有多少競爭對手進入。我們不確定巴瑞替尼是否會進入市場。我們得看看。我們還沒有看到太多輝瑞的活動。為了給你某種國際視角，在加拿大市場，我們看到幾個季度後，此時真的只有 Dupi 和 Rinvoq，我們看到加拿大 30% 的遊戲份額。

So we are, as I mentioned, very, very encouraged with the early adoption. In particular, my comment around how fast, once you see the first prescription take place with some of those productive doctors, how fast they go to the second or third. To give you some flavor of what we see in the U.S., and again, the data is early, we see, as expected, the majority of our use so far in that dynamic market are not switches necessarily. We see about, let's say, 1/3, believe it or not, that are not even exposed to Dupi.

因此，正如我所提到的，我們對早期採用感到非常非常鼓舞。特別是，我的評論是關於多快，一旦你看到一些高效的醫生開出第一個處方，他們到第二個或第三個的速度有多快。為了讓您了解我們在美國看到的情況，而且數據還很早，我們看到，正如預期的那樣，到目前為止，我們在這個充滿活力的市場中的大部分使用不一定是開關。我們看到，比如說，1/3，信不信由你，甚至沒有接觸到 Dupi。

And the doctors are saying, look, I've already given another oral systemic, for example, but the itch in the skin is so severe that they're going to go, I'm going to go right and get the relief with Rinvoq. And then maybe the other 2/3, you see Dupi partial responders, particularly related to the itch just isn't suppressed as much, and they still have some skin involvement. Or there is, as we've highlighted before, a warehouse of Dupi nonresponders that has been built up over the last 4 years. So that's the behavior that we see. Again, I'm very encouraged on the early results, not just in the U.S. but around the world. Rinvoq is going to be a real player in this underserved market.

醫生說，看，我已經給了另一種口服系統，例如，但是皮膚瘙癢非常嚴重，他們會去的，我會去正確的，用 Rinvoq 來緩解.然後也許另外 2/3，你會看到 Dupi 部分反應者，特別是與瘙癢有關的，只是沒有被抑制得那麼好，而且他們仍然有一些皮膚受累。或者，正如我們之前強調的那樣，在過去 4 年中建立了一個 Dupi 無響應者倉庫。這就是我們看到的行為。同樣，我對早期結果感到非常鼓舞，不僅在美國，而且在世界各地。 Rinvoq 將成為這個服務不足的市場的真正參與者。

Our next question is from Steve Scala from Cowen.

我們的下一個問題來自 Cowen 的 Steve Scala。

Two questions. First on epcoritamab, the data looks great. Could this molecule immediately start taking share from CAR-T? Or do you think physicians will want to see durability data before selecting a bispecific ahead of a cell therapy? So that's the first question.

兩個問題。首先在 epcoritamab 上，數據看起來很棒。這種分子能否立即開始從 CAR-T 中分一杯羹？或者您認為醫生在選擇雙特異性細胞療法之前會希望查看耐久性數據嗎？所以這是第一個問題。

The second question is, I'm trying to sift through the answer to the Humira question just a moment ago. On the one hand, it seems we need to consider that Humira could be more resilient in 2023 than expected. On the other hand, the Street needs to raise spending assumptions. So would you object to either of those conclusions based on what was stated?

第二個問題是，我正在嘗試篩選剛才 Humira 問題的答案。一方面，我們似乎需要考慮到 Humira 在 2023 年可能比預期更具彈性。另一方面，華爾街需要提高支出假設。那麼，您會根據所陳述的內容反對這些結論中的任何一個嗎？

Thanks, Steve. This is Neil. I'll take the first question on epcoritamab. The fact that we saw such remarkable activity in a patient population that had failed CAR-T does not imply that the medicine should be positioned after failure of CAR-T. I think they are 2 very different classes of medicines, as you know. CAR-T has significant challenges with respect to the need for -- prior to administration. Whereas the safety profile with epcoritamab is extremely manageable. And again, I don't want to repeat what I said earlier on around CRS.

謝謝，史蒂夫。這是尼爾。我將回答關於 epcoritamab 的第一個問題。我們在 CAR-T 失敗的患者群體中看到如此顯著的活動這一事實並不意味著藥物應該在 CAR-T 失敗後定位。如您所知，我認為它們是兩種截然不同的藥物。 CAR-T 在給藥前的需求方面面臨著重大挑戰。而 epcoritamab 的安全性非常易於管理。再說一次，我不想重複我之前在 CRS 上所說的話。

So overall, we see a very strong benefit risk profile emerging for the medicine. And therefore, our intention is to move the medicine into earlier lines of therapy initially gain an approval with respect to -- gain approval in relapsed/refractory DLBCL and after that move to the -- move to medicine into earlier lines of therapy.

因此，總體而言，我們看到該藥物出現了非常強大的收益風險特徵。因此，我們的意圖是將藥物轉移到早期治療線，最初獲得批准——在復發/難治性 DLBCL 中獲得批准，然後轉移到——將藥物轉移到早期治療線。

Steve, this is Rick. I think Rob and I will handle the second question for you. Yes. Look, I think it's a great question, and we've gotten that question a lot. What's the erosion going to be in '23? And is it going to be lighter in '23 and therefore, spill more into '24. And I think that's a reasonable question to start to think through. I'd say as I step back and look at it, I would tell you this. Look, at the end of the day, it could be lighter in '23. That would force more of it out into '24.

史蒂夫，這是瑞克。我想 Rob 和我會為你處理第二個問題。是的。看，我認為這是一個很好的問題，我們已經收到了很多這個問題。 23 年會發生什麼侵蝕？它會在 23 年變得更輕，因此會更多地溢出到 24 年。我認為這是一個開始思考的合理問題。我會說，當我退後一步看它時，我會告訴你這個。看，在一天結束時，它可能會在 23 年變得更輕。這將迫使更多的它進入'24。

If I look at the business, that's a good thing. It would give us higher cash flows in '23 than what we would be projecting now. Ultimately, I think there will be a settling out between '23 and '24. We'll still get to the levels that we have described or at least that we are modeling. And I think the important thing is, look, Humira is going to play out over these 2-year period of time. What's important to AbbVie, though, is what's that underlying growth that's driving the business and is going to sustain the growth on the other side of the LOE. That's the critical aspect of it.

如果我看一下業務，那是一件好事。這將使我們在 23 年的現金流量高於我們現在的預期。最終，我認為在 23 年和 24 年之間會有一個解決方案。我們仍然會達到我們所描述的水平，或者至少是我們正在建模的水平。我認為重要的是，看，修美樂將在這 2 年的時間內發揮作用。不過，對 AbbVie 來說重要的是，推動業務發展的潛在增長是什麼，並將維持 LOE 另一側的增長。這是它的關鍵方面。

Skyrizis, the Rinvoqs, our Neuroscience pipeline, Aesthetics, it's all of those major growth drivers that we have because that growth is going to be suppressed in '23 and somewhat maybe in '24. But as soon as that pressure is off, that's when it will reemerge and be able to deliver growth on the other side of it. And so what we're focused on is, obviously, we're going to try to manage the '23-'24 dynamic to the extent that we're able to. But that's not the most critical part for the business. The most critical part is driving these growth brands and delivering on the pipeline.

Skyrizis、Rinvoqs、我們的神經科學管道、美學，這都是我們擁有的所有主要增長動力，因為這種增長將在 23 年受到抑制，在某種程度上可能會在 24 年受到抑制。但一旦這種壓力消失，它就會重新出現，並能夠在它的另一邊實現增長。因此，我們關注的是，顯然，我們將嘗試在我們能夠做到的範圍內管理“23-24”動態。但這並不是企業最關鍵的部分。最關鍵的部分是推動這些增長品牌並在管道中交付。

And this is Rob. What I would add, Steve, just to clarify, I mean, we have a business that's going to deliver high single-digit growth during 2025. It doesn't make sense to be cutting investment in '23. And that's what the Street consensus is modeling currently. So we expect to invest in this business, invest in R&D, invest in SG&A to drive that long-term growth. And given how quickly we'll return to that growth, I wouldn't expect us to be cutting investments in '23.

這是羅伯。史蒂夫，我要補充的是，我的意思是，我們的業務將在 2025 年實現高個位數增長。在 23 年削減投資是沒有意義的。這就是華爾街共識目前正在建模的內容。因此，我們希望投資於這項業務，投資於研發，投資於 SG&A 以推動長期增長。考慮到我們恢復增長的速度有多快，我不認為我們會在 23 年削減投資。

Our next question comes from Andrew Baum from Citi.

我們的下一個問題來自花旗的 Andrew Baum。

Question for Jeff. Perhaps you could comment on the impact of IL-31 inhibitor in atopic dermatitis where we're expecting additional Phase II data, which obviously don't have the JAK labeling associated with how you think it's going to impact the market in terms of delaying the onset of JAK therapy?

傑夫的問題。也許您可以評論 IL-31 抑製劑對特應性皮炎的影響，我們預計會有更多的 II 期數據，這些數據顯然沒有與您認為它將如何影響市場相關的 JAK 標籤延遲JAK 治療的開始？

And then second for Neil, could you talk to how large you see the commercial potential for Venclexta in t(11;14) myeloma, which is due to reported Phase III this year?

然後是 Neil，您能否談談您認為 Venclexta 在 t(11;14) 骨髓瘤中的商業潛力有多大，這將在今年報告為 III 期？

Yes. Thank you, Andrew. So important question. So the way that we see the market for the other ILs, I do think that there will be a segment of conservative dermatologists that will attempt to sequence. And I think that largely that they'll be disappointed because it seems the newer agents are very, very difficult to distinguish from Dupixent. I think certainly, there could be market access dynamics that start to appear with subsequent ILs, I think that's something that we will watch and you would want to watch.

是的。謝謝你，安德魯。這麼重要的問題。因此，從我們看待其他 IL 市場的方式來看，我確實認為會有一部分保守的皮膚科醫生會嘗試進行測序。而且我認為很大程度上他們會感到失望，因為新代理似乎非常非常難以與 Dupixent 區分開來。我認為當然，隨著後續 IL 的出現，市場准入動態可能會開始出現，我認為這是我們將要觀察的事情，你會想觀察的。

I think what's, again, maybe not appreciated as we watch the early quarters of performance in Europe and the first quarter of performance here in the U.S. is that there's significant amount of early adopters and dermatologists that will go right to a JAK inhibitor, as I mentioned. They're not always sequencing through Dupi. And it's because of the severity of some of these patients and the level of the clinical involvement is very, very significant. And so we do see what you would call a significant amount of naive use based on the profile of the JAK inhibitor.

我認為，當我們觀察歐洲早期幾個季度的表現和美國第一季度的表現時，我認為可能不值得讚賞的是，有大量的早期採用者和皮膚科醫生會直接使用 JAK 抑製劑，因為我提及。他們並不總是通過 Dupi 進行排序。這是因為其中一些患者的嚴重程度以及臨床受累程度非常非常重要。因此，根據 JAK 抑製劑的概況，我們確實看到了您所說的大量幼稚使用。

Now these are early adopters. These are people that have already contemplated the risk benefit, and I think that's important. And so the way that we see the market developing is that when physicians would start with Dupi, which will be in a significant proportions of patients, it's not clear at all that their next step will be another IL that has been approved or will be approved. In fact, we think it's more likely that they will move towards the best JAK that can get to these high levels of skin clearance, the easy 90 plus, almost no perceived itch. And I think that's the endpoint that this market is going to move towards and Rinvoq is the drug that clearly can deliver on that promise. And so that's how we see the market developing, and that's why we remain encouraged on the early results around the world from what we're seeing with the agent.

現在這些都是早期採用者。這些人已經考慮過風險收益，我認為這很重要。因此，我們看到市場發展的方式是，當醫生從 Dupi 開始時，這將在相當大比例的患者中使用，完全不清楚他們的下一步將是另一個已獲批准或將獲批准的 IL .事實上，我們認為他們更有可能朝著能夠達到這些高水平皮膚清除率的最佳 JAK 前進，即簡單的 90 歲以上，幾乎沒有明顯的瘙癢。我認為這是這個市場將要走向的終點，而 Rinvoq 顯然是可以兌現這一承諾的藥物。這就是我們如何看待市場發展的方式，這就是為什麼我們仍然對我們與代理所看到的世界各地的早期結果感到鼓舞。

This is Neil. With respect to the question on Venclexta, venetoclax CANOVA. So the CANOVA study is a study of venetoclax in multiple myeloma patients with a particular translocation, t(11;14). We're making extremely good progress with the study, and we fully anticipate having a Phase III data from the study during the course of 2022. We know from this particular patient population that were included in earlier studies with Venclexta that they are explicitly sensitive to treatment with the medicines in various combinations.

這是尼爾。關於 Venclexta 的問題，venetoclax CANOVA。因此，CANOVA 研究是一項針對具有特定易位 t(11;14) 的多發性骨髓瘤患者的維奈托克的研究。我們在這項研究中取得了非常好的進展，我們完全預計在 2022 年期間將獲得該研究的 III 期數據。我們從 Venclexta 早期研究中包含的這一特定患者群體中得知，他們對用各種組合的藥物進行治療。

The prevalence of this population is around 20% of multiple myeloma and multiple myeloma, as you know, is the commonest hematologic malignancy. So this is a very significant proportion of the multiple myeloma population that could gain benefit from Venclexta. And as mentioned, we're looking forward to being able to communicate the Phase III data during the course of 2022. Thanks for the question.

這一人群的患病率約為多發性骨髓瘤的 20%，而眾所周知，多發性骨髓瘤是最常見的血液系統惡性腫瘤。所以這是可以從 Venclexta 中受益的多發性骨髓瘤人群中的一個非常重要的比例。如前所述，我們期待能夠在 2022 年期間傳達 III 期數據。感謝您的提問。

Our next question comes from Chris Schott from JPMorgan.

我們的下一個問題來自摩根大通的 Chris Schott。

First one for me is just can you elaborate a bit more on Rinvoq coverage, both in AD and UC. I guess just trying to get a sense of where we are today and what's the outlook for the next few quarters? And maybe as part of that, it seems like you're seeing some nice uptake in your bridge programs. Can you just comment when you expect we should start to think about those translating over to third-party Rxs and that would be maybe more visible to the outside world in terms of how that uptick you're seeing?

對我來說，第一個問題是您能否詳細說明 Rinvoq 的覆蓋範圍，包括 AD 和 UC。我想只是想了解我們今天所處的位置以及未來幾個季度的前景如何？也許作為其中的一部分，您似乎在您的橋樑計劃中看到了一些很好的吸收。當您期望我們應該開始考慮將那些轉換為第三方 Rxs 的時候，您能否發表評論，並且就您所看到的上升情況而言，這可能對外界更加明顯？

And then my second question was just on Q1 itself. Were there any notable either payer adjustments or gross to net issues? I guess Humira, for example, it seems like the low single-digit growth was a departure from recent trends. I'm just trying understand a little bit better what happened in the quarter. Is there anything we should just be kind of keeping in mind as we consider the Q1 results?

然後我的第二個問題就在第一季度本身。是否有任何值得注意的付款人調整或總淨問題？例如，我猜 Humira 的低個位數增長似乎與最近的趨勢背道而馳。我只是想更好地了解本季度發生的事情。在考慮第一季度的結果時，有什麼我們應該記住的嗎？

Yes. Thank you, Chris. It's Jeff. So with your first question is -- we're very confident that we are going to get to high levels of paid access for Rinvoq and Skyrizi's new indications. So typically, what we'll see based on the approval time line, we'll be ramping up into the -- by the middle of the year up into the -- up in the high 90s in terms of our access -- for commercial access. So I think that everyone should be confident that, that's where you're going to start to see this bridge program start to fully convert as the months go by into the paid prescription. So typically, that's the timing we're looking at. You're going to see very strong momentum on paid access by -- towards the end of next quarter is what we've guided towards. So that's the answer to your first question.

是的。謝謝你，克里斯。是傑夫。所以你的第一個問題是——我們非常有信心，我們將為 Rinvoq 和 Skyrizi 的新適應症提供高水平的付費訪問。因此，通常情況下，我們將根據批准時間線看到，我們將加速到 - 到今年年中 - 在我們的訪問權方面達到 90 年代的高點 - 用於商業使用權。所以我認為每個人都應該相信，隨著幾個月的時間推移，你將開始看到這個過渡計劃開始完全轉換為付費處方。所以通常情況下，這就是我們正在考慮的時間。到下個季度末，您將看到付費訪問的強勁勢頭，這是我們的指導方針。這就是你第一個問題的答案。

I think if you think about -- and maybe just to frame the Humira question. The Humira fundamentals are, and the market fundamentals are quite strong. You see the markets are performing nicely. Our market share growth trends, we haven't seen any trend shift. They've been largely stable. There's some sequential decline based on the size of the market and actually our own brand, Skyrizi and Rinvoq that are playing very strongly into these markets.

我想如果你考慮一下——也許只是為了框定 Humira 的問題。 Humira 的基本面是，市場基本面相當強勁。您會看到市場表現良好。我們的市場份額增長趨勢，我們沒有看到任何趨勢轉變。他們基本上是穩定的。基於市場規模，實際上我們自己的品牌 Skyrizi 和 Rinvoq 在這些市場中發揮了非常強大的作用，因此出現了一些連續下降。

What I would say is that, in some cases, Q1 can be quite unique over the years. You've got the issue with the plans resetting their deductibles, you've got issues with doctors that have to put in another prior authorization for the year. And so you do see some co-pay and sort of deductible dynamic. But we think that's really a first quarter type of event, and it's largely been very consistent with what we expected. So maybe I don't know, Rob, if you want to build on that a little bit.

我想說的是，在某些情況下，Q1 多年來可能非常獨特。您遇到了計劃重置其免賠額的問題，您遇到了醫生的問題，必須在該年度進行另一項事先授權。所以你確實看到了一些共同支付和免賠額的動態。但我們認為這確實是第一季度的活動，並且在很大程度上與我們的預期非常一致。所以也許我不知道，Rob，如果你想在此基礎上再做一點。

Yes. I would just add that if you look back to our guidance for the quarter, and we gave guidance to the therapeutic area level, we pretty much came in line with that guidance. And so we expected this dynamic, and we're also -- we're not changing our full year outlook for U.S. Humira, 8% growth. And that, again, will be driven by market driving volume growth. And so -- it's in line with our expectations. I understand Street consensus had a different point of view, but we weren't surprised by that.

是的。我只想補充一點，如果您回顧我們對本季度的指導，並且我們對治療領域水平提供了指導，我們幾乎與該指導一致。因此，我們預計會出現這種動態，而且我們也沒有改變對美國 Humira 全年增長 8% 的展望。這將再次受到市場推動銷量增長的推動。所以——這符合我們的預期。我知道街頭共識有不同的觀點，但我們對此並不感到驚訝。

Our next question comes from Chris Shibutani from Goldman Sachs.

我們的下一個問題來自高盛的 Chris Shibutani。

If I could ask on Vraylar, the product, I think you comment expectations for an MDD approval and yet they'll frame it as potential for upside. Can you help us understand perhaps some of the potential there? Just thinking back to some of the scale of the peak sales opportunity that, that drug was characterized previously, MDD certainly seems as if it's a potential significant opportunity.

如果我可以詢問產品 Vraylar，我認為您會評論對 MDD 批准的期望，但他們會將其視為潛在的上行空間。您能幫助我們了解其中的一些潛力嗎？回想一下高峰銷售機會的一些規模，即該藥物之前的特徵，MDD 似乎肯定是一個潛在的重要機會。

Yes. Thank you for the question. And it is a significant opportunity. So as we highlighted and Tom highlighted, the NDA has been accepted, and we're confident in the approval. I think what we said in the past is that just with the base indication. So before we get that approval, I mean, the FDA has to still approve it towards the end of the year. We believe that we can ramp towards a $4 billion opportunity.

是的。感謝你的提問。這是一個重要的機會。因此，正如我們強調和 Tom 強調的那樣，NDA 已被接受，我們對批准充滿信心。我認為我們過去所說的只是基本指示。因此，在我們獲得批准之前，我的意思是，FDA 仍然必須在年底前批准它。我們相信我們可以實現 40 億美元的機會。

So that would mean our share just in the base indications of a unique profile with the mania, the mixed manian depression, the bipolar depression, we moved somewhere up sort of doubling our share penetration. So right now, we're at about 2.7% TRx share. So we'd really get close to doubling that based on the momentum. And then MDD would build on top of that.

因此，這意味著我們的份額只是在躁狂症、混合性躁狂抑鬱症、雙相抑鬱症的獨特特徵的基本跡像中，我們移動到某個地方，使我們的份額滲透率翻了一番。所以現在，我們的 TRx 份額約為 2.7%。因此，根據勢頭，我們真的會接近翻倍。然後 MDD 將建立在此之上。

And so it's significant. I mean, the physicians that we've talked to when we show them the profile are very pleased. First, they know Vraylar, they like Vraylar. They like the strong efficacy, they highlight -- it's nonsedating. They highlight, at least verbally, a brightening effect of the agent, minimal weight gain, metabolic effects. And so as they think about that, how that would translate to adjunctive MDD, they like that profile.

所以這很重要。我的意思是，當我們向他們展示個人資料時，我們與之交談過的醫生非常高興。首先，他們了解 Vraylar，他們喜歡 Vraylar。他們喜歡強大的功效，他們強調——它沒有鎮靜作用。他們至少在口頭上強調了該藥劑的增亮效果、最小的體重增加和代謝效果。因此，當他們考慮這一點時，這將如何轉化為輔助 MDD，他們喜歡這種配置文件。

The other piece that we hear is they like the starting dose. They like that starting dose, so the 1.5 milligram dose, which is what we believe that ultimately will be approved. We'll have to see. So easy to start, easy to take, well tolerated. And so to your point, we believe that MDD will offer some upside and acceleration to the brand's momentum when we achieve it.

我們聽到的另一件事是他們喜歡起始劑量。他們喜歡那個起始劑量，所以 1.5 毫克的劑量，我們相信這最終會被批准。我們得看看。如此容易上手，易於服用，耐受性好。因此，就您的觀點而言，我們相信，當我們實現這一目標時，MDD 將為品牌的發展勢頭帶來一些好處和加速。

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。

Just maybe get back to some of what we were just talking about around the pricing in 1Q. But I had a couple of questions regarding the migraine franchise. So the Ubrelvy scripts from [recently] publicly, third-party data, it looks like the gross to net -- so net pricing is back to where we were in 1Q '21. I'm just trying to understand if this is just a seasonality things or 4Q to 1Q dynamic or maybe there might be something broader where net pricing for these products is going down.

只是也許回到我們剛剛談論的第一季度定價的一些內容。但我有幾個關於偏頭痛專營權的問題。因此，來自 [最近] 公開的第三方數據的 Ubrelvy 腳本看起來像是總淨值 - 所以淨定價回到了我們在 21 年第一季度的水平。我只是想了解這只是季節性因素還是 4Q 到 1Q 的動態變化，或者這些產品的淨定價可能會出現更廣泛的下降。

And then tied to that, with Qulipta, as you mentioned, the prescription numbers are pretty good as it builds up here. I'm curious now that you have sort of 2 products in that market, does that impact how you're thinking about the opportunity, especially from a pricing side or sort of payer negotiation side? Is there any thoughts on sort of bundling the 2 together in any way to potentially getting even better access than what you have right now? So any thoughts you could share there would be helpful as well.

然後與 Qulipta 聯繫起來，正如你所提到的，處方數量非常好，因為它在這裡建立起來。我現在很好奇你在那個市場上有兩種產品，這是否會影響你對機會的看法，尤其是從定價方面或付款方談判方面？是否有任何想法以任何方式將兩者捆綁在一起以可能獲得比您現在擁有的更好的訪問權限？因此，您可以在那里分享的任何想法也會有所幫助。

So Vamil, this is Rob. I'll take your first question. So when you look at, yes, there is seasonality in this market in the U.S., and so you do see a shift from Q4 to Q1. If you look at year-over-year, you'd see that in Q4, as you mentioned, Q1 year-over-year is relatively flat. I would think about it that way for the full year as well. So you do tend to see a suppression in Q1 because of plans resetting that dynamic we see in the U.S. market. But then over the course of the rest of the year, you do see higher pricing. So on average, the way to think about it is price is relatively stable.

所以瓦米爾，這是羅布。我會回答你的第一個問題。所以當你看時，是的，美國這個市場存在季節性，所以你確實看到了從第四季度到第一季度的轉變。如果你看同比，你會發現在第四季度，正如你所提到的，第一季度同比相對持平。我也會這樣想一整年。因此，由於計劃重置我們在美國市場看到的動態，您確實傾向於在第一季度看到抑制。但是在今年剩下的時間裡，你確實會看到更高的定價。所以平均而言，考慮它的方式是價格是相對穩定的。

And Vamil, it's Jeff now. So I think -- look, we are pleased with the Ubrelvy momentum. I mean, actually, since we launched Qulipta, Ubrelvy has accelerated. So we have to -- because we can't see the competitor because you can see the whole thing. But when we factor Nurtec by 8 versus 16, and we try to understand the acute dynamic, we can see that we're clearly the market-leading acute CGRP and that's nice to see. The physicians really like Ubrelvy, the markets are robust. I think what you're seeing is what Rob highlighted in terms of the overall performance.

Vamil，現在是 Jeff。所以我認為 - 看，我們對 Ubrelvy 的勢頭感到滿意。我的意思是，實際上，自從我們推出 Qulipta 以來，Ubrelvy 已經加速發展。所以我們必須——因為我們看不到競爭對手，因為你可以看到整個事情。但是，當我們將 Nurtec 分解為 8 對 16 時，我們試圖了解急性動態，我們可以看到我們顯然是市場領先的急性 CGRP，這很高興看到。醫生真的很喜歡 Ubrelvy，市場很強勁。我認為您所看到的是 Rob 在整體性能方面所強調的。

I didn't really fully appreciate your second question in terms of the access, I can give you a broad overview. Obviously, we're seeing great momentum with the brand. Much of the brand is still because the access that's ramping is still bridged, just like we discussed there with the immunology agent. So we think, again, by the middle of the year, we're going to see commercial access really start to ramp, and you'll see the conversion start to take place.

關於訪問權限，我並沒有完全理解你的第二個問題，我可以給你一個廣泛的概述。顯然，我們看到了該品牌的強勁勢頭。大部分品牌仍然是因為正在增加的訪問仍然是橋接的，就像我們在那裡與免疫學代理討論的那樣。因此，我們再次認為，到今年年中，我們將看到商業訪問量真正開始增加，您會看到轉換開始發生。

What's nice is that we're confident in that. We think that our price points and net price or negotiations are going well. And because of its unique profile, as an agent, basically, the strength of the drug is really significant in terms of its performance against episodic migraine. We feel like we're in good shape. And we're going to build on top of that, basically 25% in-play share, which is right now at the top of the league table. So that's how we see it. We're confident in the access ramp.

好的是我們對此充滿信心。我們認為我們的價格點和淨價或談判進展順利。而且由於其獨特的特徵，作為一種藥物，基本上，該藥物的強度在其對抗發作性偏頭痛的表現方面非常重要。我們覺得我們的狀態很好。我們將在此基礎上再接再厲，基本上是 25% 的比賽中份額，目前處於聯賽榜首。這就是我們的看法。我們對入口坡道充滿信心。

Maybe just to clarify the second question I'm just [thinking for] Ubrelvy, is there any advantage of another strategy you might have now because you have 2 approved migraine oral therapies? Or is it pretty much similar it would be if you had one or the other?

也許只是為了澄清第二個問題，我只是 [思考] Ubrelvy，因為您有 2 種批准的偏頭痛口服療法，您現在可能擁有的另一種策略是否有任何優勢？或者如果你有一個或另一個，它會非常相似嗎？

Yes. It's pretty similar based on the way that the pricing and the different dynamics work on the other CGRP. It's not -- it's just sort of a straight -- it's a straight play on the access there.

是的。基於定價方式和不同動態在其他 CGRP 上的工作方式非常相似。這不是——它只是一種順子——它是在那裡的入口處的順子。

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

我們的下一個問題來自美國銀行的 Geoff Meacham。

I just had another one on the INI landscape. Rick, when you look at the market disruption that you'll see in '23 and '24, presumably, that's going to have an indirect effect on Skyrizi and Rinvoq when you think pricing and share. What would you guys view as a win over this period from a new start or switch perspective or a growth perspective is the first question. And the second part of it is, what gives you guys confidence when the market really normalizing after a 2024 period?

我剛剛在 INI 領域又多了一個。里克，當你看到 23 年和 24 年的市場混亂時，大概，當你考慮定價和份額時，這將對 Skyrizi 和 Rinvoq 產生間接影響。第一個問題是，從新的開始或轉換的角度或增長的角度來看，你們會如何看待這一時期的勝利。第二部分是，當市場在 2024 年之後真正恢復正常時，是什麼讓你們有信心？

I think as we look at our long-range plan, we don't see or anticipate a dramatic impact. We've provided that 2025 guidance and I think it's reflective of significant growth of Skyrizi and Rinvoq. If you look at those assets and you look at their clinical performance, they really stand out. And that's what's driving the kind of volume and growth that we're seeing. And I think you will see obvious price disruption in the Humira market from biosimilars. But I don't anticipate that you're going to see that bleed over in a significant way to those other assets. Jeff, do you see any differently?

我認為，當我們審視我們的長期計劃時，我們看不到或預計不會產生巨大的影響。我們已經提供了 2025 年的指導，我認為這反映了 Skyrizi 和 Rinvoq 的顯著增長。如果您查看這些資產並查看它們的臨床表現，它們真的很突出。這就是推動我們所看到的數量和增長的原因。而且我認為你會看到生物仿製藥對 Humira 市場的明顯價格干擾。但我預計您不會看到這種情況對其他資產產生重大影響。傑夫，你有什麼不同嗎？

Yes. I don't see, Geoff, much difference. I mean if you think of it in some ways, even on -- let's take Rinvoq, for example. I mean, you could say, wow, in prior viewpoints, maybe everyone will step behind a biosimilar at some point in the future. Well, one, we didn't think that, that would happen wide scale as the market develops anyway. But even if it did, our label is already behind a TNF. And so when you look at the level of efficacy that Rinvoq's bringing in those later lines, I mean it's -- we're really quite insulated from that, I would put forth.

是的。傑夫，我看不出有什麼不同。我的意思是，如果你以某種方式考慮它，甚至是——讓我們以 Rinvoq 為例。我的意思是，你可以說，哇，在以前的觀點中，也許每個人都會在未來的某個時候落後於生物仿製藥。嗯，一，我們不認為，隨著市場的發展，這種情況會大規模發生。但即使是這樣，我們的標籤也已經落後於 TNF。因此，當您查看 Rinvoq 帶來的那些後期線路的效力水平時，我的意思是——我們真的完全不受此影響，我會提出。

And second Skyrizi is just -- is a phenomenal asset. I mean the level of performance and what it's doing to transform certainly psoriasis today, PSA right now and what we think will happen with Crohn's and ultimately, IBD, when you look at the level of healing and sort of restating that standard of care, we think the assets themselves are quite well positioned for the middle part of the decade, and that sort of goes to the elements of the planning that Rick talked about.

第二個 Skyrizi 只是 - 是一項非凡的資產。我的意思是性能水平以及它在今天改變銀屑病的作用，現在的 PSA 以及我們認為克羅恩病和最終 IBD 會發生的事情，當您查看癒合水平並重申該護理標準時，我們認為資產本身在本世紀中期的定位相當不錯，這與 Rick 談到的規劃要素有關。

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。

First, just following on that last response. Can you talk more broadly about how you see the expansion of Rinvoq and Skyrizi into the IBD indication? So how is the initial launch for Rinvoq in ulcerative colitis going? I know it's early days, but what's the outlook there given physician receptivity around the product? Are physicians saying they're excited to have Rinvoq for Crohn's as well? And also, how do you see Skyrizi fitting in with Crohn's versus Rinvoq? And then secondly, on Aesthetics, it was strong in the first quarter, but did you see any impact in the early part of 1Q from Omicron? And what have the trends been more recently in March and April in the Aesthetics business?

首先，只是按照最後的回應。您能否更廣泛地談談您如何看待 Rinvoq 和 Skyrizi 擴展到 IBD 適應症？那麼 Rinvoq 在潰瘍性結腸炎中的首次發布進展如何？我知道現在還為時尚早，但是鑑於醫生對該產品的接受度，那裡的前景如何？醫生們是否說他們很高興 Rinvoq 也能治療克羅恩病？此外，您如何看待 Skyrizi 與 Crohn's 與 Rinvoq 的關係？其次，在美學方面，第一季度表現強勁，但您是否看到 Omicron 在第一季度早期有任何影響？ 3 月和 4 月美容行業的最新趨勢是什麼？

Yes. Thank you for the question. It's Jeff again. So we are very, very encouraged by the IBD momentum that we can build. And we're right on the cusp of it. And to give some sense is basically this market -- the market of Crohn's and you see that -- it actually has fairly high biologic penetration. When we do our research and our engagement with the physicians, what they typically have done for more than a decade since the availability of Remicade and then Humira, they really hang on as much as possible to their first-line use.

是的。感謝你的提問。又是傑夫。所以我們對我們可以建立的 IBD 勢頭感到非常非常鼓舞。我們正處於風口浪尖。並且給出一些意義基本上是這個市場 - 克羅恩病的市場，你看到 - 它實際上具有相當高的生物滲透率。當我們進行研究並與醫生接觸時，自 Remicade 和 Humira 上市以來他們通常已經做了十多年的工作，他們真的盡可能多地堅持一線使用。

They try to intensify, they do all sorts of things because it's quite scary for the physicians and the patients because no one set a different standard of care. So when you start to look at the healing rates that we start to see with Rinvoq in UC, the healing of the bowel, the remission rate, the combination of what we can see, this market looks very, very good to have both of those assets come in with higher standards of care. So we're very, very encouraged, and we think that the IBD market is probably underappreciated in terms of what that looks like.

他們試圖加強，他們做各種各樣的事情，因為這對醫生和病人來說都很可怕，因為沒有人設定不同的護理標準。因此，當您開始查看我們在 UC 中使用 Rinvoq 開始看到的治愈率、腸道的治愈率、緩解率，以及我們所看到的組合時，這個市場看起來非常非常好，同時擁有這兩者資產具有更高的護理標準。所以我們非常非常鼓舞，我們認為 IBD 市場可能被低估了。

And the patients are so challenged with their disease because it's quite severe with the bowel preparations, the hospitalizations, all of these things, having 2 assets is a great thing to bring to the market. Certainly, in the U.S., it's likely we see that with UC today that you're going to have later line use based on the labeling. Skyrizi is not going to have that limitation. So you can imagine that you have an ability to co-position to sequence appropriately, to think about how you bring that whole portfolio around the world, and that's how we see it. We're quite encouraged that we would have both Rinvoq for Crohn's and Rinvoq for Skyrizi in the market.

患者的疾病如此嚴峻，因為腸道準備，住院治療，所有這些事情都非常嚴重，擁有兩項資產是推向市場的好東西。當然，在美國，我們很可能會看到今天的 UC，您將根據標籤在以後使用線路。 Skyrizi 不會有這種限制。所以你可以想像你有能力共同定位以適當地排序，考慮如何將整個投資組合帶到世界各地，這就是我們的看法。我們感到非常鼓舞的是，我們將在市場上同時擁有適用於 Crohn 的 Rinvoq 和適用於 Skyrizi 的 Rinvoq。

And it's kind of very similar to my comments I made on what's happening with PSA today in rheumatology, where both of those assets Rinvoq for PSA and Skyrizi PSA are in the market together working as a portfolio. To get to your first point, it's been only a month or so with our UC launch, but the physicians gastros are very encouraged with the profile. They've not seen the level of remission or the level of healing, before, in any asset. So there's quite a wow reaction to the efficacy profile.

這與我對 PSA 今天在風濕病學中發生的事情的評論非常相似，其中 Rinvoq for PSA 和 Skyrizi PSA 的這些資產在市場上作為一個投資組合一起工作。說到你的第一點，我們的 UC 發布僅過了一個月左右，但是醫生們對這個簡介感到非常鼓舞。他們之前沒有看到任何資產的緩解水平或癒合水平。所以對功效概況有相當大的反應。

They realize that they have to think about, I've got to think through my patients that are not doing well on TNF or have cycled through a TNF and are struggling. And I mentioned that's a pretty large addressable population. It's at least 50% of the market today. So early qualitative results are quite strong. And the bridge results are also quite strong. So we're pleased with the gastro launches thus far.

他們意識到他們必須考慮，我必須考慮我的患者在 TNF 上表現不佳或已經通過 TNF 循環並且正在苦苦掙扎。我提到這是一個相當大的可尋址人群。它至少佔當今市場的 50%。所以早期的定性結果是相當強的。而且橋牌效果也相當強。因此，我們對迄今為止的 Gastro 發布感到滿意。

Carrie?

嘉莉？

Gary, this is Carrie Strom, President of Global Allergan Aesthetics, and I'll take your question about the aesthetics market. And in Q1, we did see U.S. toxin and filler markets, both growing in the mid-20s percent. And we expect that sort of growth to continue for the rest of 2022. And the way to think about it is similar amount of absolute volume growth as '21, but of course, off of a larger base.

加里，我是艾爾建全球美學總裁 Carrie Strom，我會回答你關於美學市場的問題。在第一季度，我們確實看到了美國毒素和填充劑市場，兩者都在 20% 左右增長。我們預計這種增長將在 2022 年剩餘時間內繼續。考慮它的方式是與 21 年類似的絕對銷量增長量，但當然，基數更大。

And in terms of what's driving that market growth, we're seeing very strong demand trends supported by our increased commercial investments, for example, increased consumer activation for acquisition and retention, field force expansions in key markets. And we see these trends also supported just by fundamentals and aesthetics that will continue in the long term. People think about aesthetics more like health and wellness. It's been much more destigmatized, and we see factors like social media and word of mouth continuing to drive aesthetics in the future.

就推動市場增長的因素而言，我們看到了非常強勁的需求趨勢，這得益於我們增加的商業投資，例如，為獲取和保留而增加的消費者激活，關鍵市場的現場力量擴張。我們看到這些趨勢也得到了長期持續的基本面和美學的支持。人們認為美學更像是健康和保健。它的污名化程度更高，我們看到社交媒體和口碑等因素在未來繼續推動美學。

Your question around the pandemic, I would say that we are seeing an impact right now in China, and we anticipate that, this recent surge of COVID cases in China, which has resulted in lockdowns across several major cities, has reduced patient traffic into aesthetic offices in China. And China is a top market for aesthetics. So we expect this to impact our near-term international performance for both toxins and fillers.

關於大流行的問題，我想說的是，我們現在在中國看到了影響，我們預計，最近中國的 COVID 病例激增，導致幾個主要城市的封鎖，減少了進入美容院的患者流量在中國的辦事處。中國是美學的頂級市場。因此，我們預計這將影響我們近期在毒素和填充劑方面的國際表現。

I should also mention that Russia is a key market for fillers globally. And as the tragic events in the Ukraine have unfolded, we have suspended operations for our Aesthetics business in Russia. So although absolute aesthetic sales in Russia are modest, like I said, Russia is among one of the largest filler markets in the world. So we expect to see an impact on our filler performance in coming quarters. But despite these dynamics, we do not need to change our total guidance for aesthetics. So we see our continued robust toxin performance in the U.S. to offset this anticipated transitory impact in both China and Russia.

我還應該提到，俄羅斯是全球填料的主要市場。隨著烏克蘭悲劇事件的展開，我們暫停了俄羅斯美容業務的運營。因此，儘管俄羅斯的絕對美容銷售額並不如我所說，但俄羅斯是世界上最大的填充物市場之一。因此，我們預計未來幾個季度我們的填料性能會受到影響。但是儘管有這些動態，我們不需要改變我們對美學的總體指導。因此，我們看到我們在美國繼續保持強勁的毒素表現，以抵消這種預期的對中國和俄羅斯的短暫影響。

Our next question comes from Robyn Karnauskas from Truist Securities.

我們的下一個問題來自 Truist Securities 的 Robyn Karnauskas。

So for epcoritamab, I just have a question on the product approval. Given the recent FDA discussion around the PI3 kinase class and sort of hinting that they want controlled data for accelerated approval, how do you view that in light of that panel, the likelihood of accelerated approval?

所以對於 epcoritamab，我只是對產品批准有疑問。鑑於最近 FDA 圍繞 PI3 激酶類的討論，並暗示他們希望獲得受控數據以加速批准，您如何看待加速批准的可能性？

And then second, just a little bit more questions around the bridge program. I think you said that you're going to expect more payment reimbursement coming online in the middle of the year. Just talk to me how long people stay in the bridge program and how you expect that bridge program to continue? And what -- how many people might continue to use it after payers come online.

其次，關於橋牌項目的問題再多一點。我想你說過你會期待更多的付款報銷在今年年中上線。只是告訴我人們在過渡計劃中停留了多長時間以及您希望過渡計劃如何繼續？還有什麼——在付款人上線後，有多少人可能會繼續使用它。

Robyn, it's Neil. I'll start off with the question around epcoritamab, but maybe just a comment -- a general comment on accelerated approval overall. I think as we're all aware, it prompted your question that the agencies in the course of -- in the process of updating its guidance with respect to accelerated approval. We haven't seen the totality of that guidance, but we anticipate hearing more from them during the course of '22.

羅賓，是尼爾。我將從有關 epcoritamab 的問題開始，但也許只是一個評論——對整體加速批准的一般性評論。我想我們都知道，這引發了你的問題，即機構在更新其關於加速批准的指導的過程中。我們還沒有看到該指導的全部內容，但我們預計在 22 年期間會聽到更多來自他們的信息。

As I alluded to, and I'm not going to repeat what I said earlier on about the epco data, but we are extremely pleased with how the molecule is performing, and it is our intent to engage with the agency based on the data that we've toplined recently. It is our intent to engage with the agency in a conversation to explore a path to accelerated approval.

正如我所提到的，我不會重複我之前所說的關於 epco 數據的內容，但我們對分子的表現非常滿意，我們打算根據數據與該機構合作我們最近已經頂線了。我們打算與該機構進行對話，以探索加速批准的途徑。

And likewise, with some of our other programs, we recently got a BTD designation for Teliso-V, for example, earlier this year with a 54% response rate in c-Met high non-small-cell lung cancer. Again, it is our intent when we have data that are this strong to continue to engage with the agency on those programs to explore potential costs to accelerated approval. So thanks for the question.

同樣，在我們的其他一些項目中，我們最近獲得了 Teliso-V 的 BTD 指定，例如，今年早些時候，在 c-Met 高非小細胞肺癌中的反應率為 54%。同樣，當我們擁有如此強大的數據時，我們的意圖是繼續與該機構就這些計劃進行合作，以探索加速批准的潛在成本。所以謝謝你的問題。

Okay. It's Jeff. Just to comment on your bridge question. Thank you for that. So the bridge transition will be very efficient. So what I mean by that is because of the connections that we have with the payers and our specialty pharmacy network, we're able to -- once access is achieved rapidly and appropriately transition patients from the bridge to basically their paid pharmacy in their prescription.

好的。是傑夫。只是為了評論你的橋牌問題。謝謝你。所以橋接過渡會非常有效。所以我的意思是因為我們與付款人和我們的專業藥房網絡建立了聯繫，我們能夠 - 一旦實現快速和適當的訪問，將患者從橋樑轉移到他們處方中的付費藥房.

So there's not going to be lingering bridge effects, particularly in the immunology space. So once it starts to move and that access ramps, the bridge transition is quite fast. And that can be within weeks or a month. And we know that that's the case because we have the models from our earlier launches from Skyrizi and Rinvoq. So ultimately, once you start to achieve those high levels of access, bridge programs drop very, very fast, and the vast majority -- the very vast majority is paid prescriptions. So it's very efficient, and I hope that helps.

所以不會有揮之不去的橋樑效應，尤其是在免疫學領域。因此，一旦它開始移動並且進入坡道，橋樑過渡非常快。這可能在幾週或一個月內。我們知道情況確實如此，因為我們擁有 Skyrizi 和 Rinvoq 早期發布的模型。所以最終，一旦你開始實現那些高水平的訪問，橋接程序下降得非常非常快，而且絕大多數——絕大多數是付費處方。所以它非常有效，我希望這會有所幫助。

Operator, we have time for one final question.

接線員，我們有時間回答最後一個問題。

Our final question comes from Josh Schimmer from Evercore ISI.

我們的最後一個問題來自 Evercore ISI 的 Josh Schimmer。

And congrats to both Mike and Tom. For Skyrizi, did your long-term outlook improve again? Or am I misunderstanding the contingent consideration line item?

並祝賀邁克和湯姆。對於 Skyrizi，您的長期前景是否再次改善？還是我誤解了或有對價行項目？

So Josh, it's Rob. If you look at the continued consideration, actually, it's a fair value liability, it went down this quarter because of discount rate. So we always have to pay attention to discount rate movement. So we saw the average discount rate increase by about 130 basis points. You're seeing, obviously, as rising interest rates are taking hold of the market, that's something we have to take into account because we had to mark this to market every quarter.

所以喬希，是羅布。如果您繼續考慮，實際上，這是一項公允價值負債，由於貼現率，它在本季度下跌。所以我們總是要注意貼現率的變動。因此，我們看到平均貼現率增加了約 130 個基點。很明顯，隨著利率上升正在佔據市場，這是我們必須考慮的事情，因為我們必須每個季度都將其標記為市場。

If you look at our release, we had a similar -- we had a decrease last year as well. Again, we had discount rates increase in Q1 of last year, albeit to a lesser extent. So that's what you're seeing is just really the discount rate movement. No other real fundamental changes to the valuation of that liability.

如果你看一下我們的發布，我們也有類似的情況——去年我們也有下降。同樣，我們在去年第一季度的貼現率有所增加，儘管幅度較小。所以這就是你所看到的只是貼現率的變動。該負債的估值沒有其他真正的根本變化。

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

好吧，謝謝你，喬希。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。