艾伯維 (ABBV) 2022 Q2 法說會逐字稿

Good morning, and thank you for standing by. Welcome to the AbbVie Second Quarter 2022 Earnings Conference Call. (Operator Instructions) I'd 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 年第二季度收益電話會議。 （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; Rob Michael, Vice Chairman and President; Jeff Stewart, Executive Vice President, Chief Commercial Officer; and Tom Hudson, Senior Vice President, R&D and Chief Scientific Officer.

早上好，感謝您加入我們。今天與我通話的還有董事會主席兼首席執行官 Rick Gonzalez； Rob Michael，副主席兼總裁； 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。

Joining us for the Q&A portion of the call are Laura Schumacher, Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary; Carrie Strom, Senior Vice President and President of Global Allergan Aesthetics; Scott Brun, Senior Vice President and Chief Financial Officer; Neil Gallagher, Vice President, Development and Chief Medical Officer; and Roopal Thakkar, Vice President, Global Regulatory affairs. Before we get started, I'll note that some statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.

與我們一起參加電話問答環節的有對外事務副主席、首席法務官兼公司秘書勞拉·舒馬赫（Laura Schumacher）； Carrie Strom，高級副總裁兼全球艾爾建美學總裁； Scott Brun，高級副總裁兼首席財務官； Neil Gallagher，開發副總裁兼首席醫療官；以及全球監管事務副總裁 Roopal Thakkar。在我們開始之前，我要指出，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。

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.

艾伯維警告說，這些前瞻性陳述存在風險和不確定性，可能導致實際結果與前瞻性陳述中的結果大相徑庭。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。

AbbVie undertakes no obligation to update these forward-looking statements, except as required by law. On today's conference call, non-GAAP financial measures will be used to help investors understand AbbVie's business performance.

除非法律要求，否則 AbbVie 不承擔更新這些前瞻性陳述的義務。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。

These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today, which can be found on our website. Following our prepared remarks, we'll take your questions. So with that, I'll now turn the call over to Rick.

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。在我們準備好的評論之後，我們將回答您的問題。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 second 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二季度的業務亮點、管道進展和財務業績。

AbbVie delivered another strong quarter with adjusted earnings per share of $3.37, exceeding our expectations. Total net revenues of approximately $14.6 billion was up 6.1% on an operational basis, in line with our expectations. This performance reflects robust double-digit operational sales growth from immunology and where Skyrizi is exceeding our expectations with impressive market share gains in both psoriasis and PSA.

艾伯維（AbbVie）又一個強勁的季度實現了調整後每股收益 3.37 美元，超出了我們的預期。運營基礎上的總淨收入約為 146 億美元，增長 6.1%，符合我們的預期。這一業績反映了免疫學強勁的兩位數運營銷售增長，以及 Skyrizi 在銀屑病和 PSA 市場份額的顯著增長超出了我們的預期。

Skyrizi's recent U.S. approval in Crohn's disease will add yet another source of long-term growth. As a result of the strong performance we've seen in the first half of the year, we are raising our full year guidance for Skyrizi. RINVOQ is also demonstrating strong growth. RA continues to perform in line with our expectations following the label update, and we're making very good progress with all of the newly launched indications, including PSA, AS, atopic dermatitis and ulcerative colitis which collectively represent a significant long-term growth opportunity.

Skyrizi 最近在美國獲得克羅恩病的批准將增加另一個長期增長的來源。由於我們在上半年看到的強勁表現，我們正在提高對 Skyrizi 的全年指導。 RINVOQ 也顯示出強勁的增長。在標籤更新後，RA 的表現繼續符合我們的預期，我們在所有新推出的適應症方面都取得了非常好的進展，包括 PSA、AS、特應性皮炎和潰瘍性結腸炎，它們共同代表了一個重要的長期增長機會.

Neuroscience is another area with outstanding performance, Vraylar, Botox Therapeutics, (inaudible), QULIPTA each demonstrated double-digit sequential sales growth. Pending regulatory approvals for Vraylar in major depressive disorder, QULIPTA in chronic migraine and ABBV-951 for the treatment of advanced Parkinson's disease represent additional near-term growth opportunities for our neuroscience portfolio.

神經科學是另一個表現突出的領域，Vraylar、Botox Therapeutics、（聽不清）、QULIPTA 均實現了兩位數的連續銷售增長。 Vraylar 治療重度抑鬱症、 QULIPTA 治療慢性偏頭痛和 ABBV-951治療晚期帕金森病的待監管批准為我們的神經科學產品組合提供了額外的近期增長機會。

Turning now to Aesthetics. Botox Cosmetic once again performed very well, with sales up more than 20% on an operational basis. Demand for toxins remains strong with high teens growth in the U.S. despite inflation dynamics. As expected, Juvederm's performance was negatively impacted by COVID-related lockdowns in China as well as the suspension of our operations in Russia.

現在轉向美學。 Botox Cosmetic 再次表現出色，營業額增長超過 20%。儘管存在通脹動態，但隨著美國青少年的高速增長，對毒素的需求仍然強勁。正如預期的那樣，Juvederm 的業績受到中國與 COVID 相關的封鎖以及我們在俄羅斯的業務暫停的負面影響。

Additionally, in the U.S., we had a difficult prior year comparison with the promotional event that we ran last year. We also saw a modest impact in the quarter due to economic pressures. We continue to expect positive full year growth for Juvederm driven by the lessening COVID impact in China and 2 new filler launches in the U.S., which will benefit growth in the second half of the year.

此外，在美國，與我們去年舉辦的促銷活動相比，我們在前一年遇到了困難。由於經濟壓力，我們在本季度也看到了適度的影響。在中國 COVID 影響減弱和美國推出 2 款新填料的推動下，我們繼續預計 Juvederm 全年實現正增長，這將有利於下半年的增長。

In hematological oncology, Imbruvica continues to be unfavorably impacted by a delayed market recovery for new patients starting therapy in CLL and increasing competition. These ongoing dynamics will have an impact on Imbruvica's projected 2022 revenues.

在血液腫瘤學方面， Imbruvica 繼續受到新患者開始治療 CLL 市場復甦延遲和競爭加劇的不利影響。這些持續的動態將對 Imbruvica 預計的 2022 年收入產生影響。

As a result, we will be adjusting our full year guidance to reflect these impacts. Venclexta continues to demonstrate robust share performance in both CLL and AML, with sales up double digits on an operational basis. Venclexta also has registrational studies ongoing in additional attractive indications such as multiple myeloma in the t(1114) patient population with Phase III data forthcoming as well as high-risk MDS.

因此，我們將調整全年指導以反映這些影響。 Venclexta 在 CLL 和 AML 中繼續表現出強勁的股票表現，在運營基礎上實現了兩位數的銷售額。 Venclexta 還在其他有吸引力的適應症中進行註冊研究，例如 t(1114) 患者群體中的多發性骨髓瘤，即將獲得 III 期數據以及高風險 MDS。

Additionally, we have an exciting and diverse pipeline of promising new therapies to address critical unmet needs in both blood cancers and solid tumors which are expected to support the next wave of AbbVie's growth in oncology. In summary, the diversity of our portfolio once again allowed us to deliver another strong performance despite the challenges we see in the CLL market and increasing Imbruvica competition.

此外，我們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，預計這將支持艾伯維（AbbVie）在腫瘤學領域的下一波增長。總之，儘管我們在 CLL 市場看到了挑戰並且 Imbruvica 競爭加劇，但我們產品組合的多樣性再次使我們能夠提供另一個強勁的表現。

Skyrizi and Rinvoq are performing exceptionally well and are on pace to deliver approximately $7.5 billion in combined sales this year. Neuroscience demonstrated balanced double-digit growth driven by migraine and Vraylar and continued robust Botox Cosmetic growth offset some of the U.S. inflationary impact to our filler and body contouring portfolios.

Skyrizi 和 Rinvoq 的表現非常出色，今年的合併銷售額有望達到 75 億美元。神經科學顯示出由偏頭痛和 Vraylar 推動的平衡兩位數增長，以及肉毒桿菌毒素化妝品持續強勁的增長抵消了美國通脹對我們的填充物和塑身產品組合的一些影響。

As a result, we are confirming our full year 2022 adjusted earnings per share guidance of $13.78 to $13.98 representing growth of more than 17% at the midpoint. With that, I'll turn the call over to Jeff for additional comments on our commercial highlights. Jeff?

因此，我們確認 2022 年全年調整後每股收益指引為 13.78 美元至 13.98 美元，中點增長超過 17%。有了這個，我將把電話轉給 Jeff，就我們的商業亮點發表更多評論。傑夫?

Thank you, Rick. I'm very pleased with the momentum across our therapeutic portfolio, including the continued progress we're making with new product and recent indication launches. I'll start with our immunology portfolio which delivered total revenues of $7.2 billion, reflecting growth of 19.2% on an operational basis.

謝謝你，瑞克。我對我們治療組合的發展勢頭感到非常滿意，包括我們在新產品和最近的適應症推出方面取得的持續進展。我將從我們的免疫學產品組合開始，該產品組合的總收入為 72 億美元，在運營基礎上增長了 19.2%。

Global Humira sales were approximately $5.4 billion, up 6.8% on an operational basis with 9.6% growth in the U.S., partially offset by international performance, where revenues were down 7.3% operationally due to biosimilar competition.

全球 Humira 銷售額約為 54 億美元，在運營基礎上增長 6.8%，其中美國增長 9.6%，部分被國際業績所抵消，由於生物仿製藥競爭，國際業務收入下降 7.3%。

Skyrizi is performing extremely well, well ahead of our expectations. Global revenues were more than $1.2 billion, up 33% on a sequential basis. We continue to advance our leadership position in psoriasis, where Skyrizi's total prescription share of the U.S. biological market has increased to approximately 26%, driven by an in-play share of new and switching patients that is now approaching 50%.

Skyrizi 的表現非常出色，遠遠超出了我們的預期。全球收入超過 12 億美元，環比增長 33%。我們繼續提升我們在銀屑病領域的領導地位，Skyrizi 在美國生物市場的總處方份額已增加到約 26%，這得益於目前接近 50% 的新患者和轉換患者的在用份額。

We have also achieved in-play market share leadership in 23 key international markets, including Japan, Germany, France, Canada and Australia. Psoriatic arthritis is also adding significantly to Skyrizi's momentum, where we are now approved in 54 countries.

我們還在日本、德國、法國、加拿大和澳大利亞等 23 個主要國際市場取得了實時市場份額領先地位。銀屑病關節炎也大大增加了 Skyrizi 的發展勢頭，我們現在在 54 個國家獲得批准。

In the U.S. Dermatology segment, where approximately 30% of patients exhibit both skin and joint involvement, Skyrizi is already achieving an in-play patient share of nearly 20%. We have also launched Skyrizi for PSA in rheumatology, where we're seeing strong utilization, which is driving accelerated share growth.

在美國皮膚科領域，大約 30% 的患者同時出現皮膚和關節受累，Skyrizi 已經實現了近 20% 的在場患者份額。我們還為風濕病學領域的 PSA 推出了 Skyrizi，我們看到該領域的利用率很高，這推動了份額的加速增長。

Our recent launch of Skyrizi for Crohn's disease in the U.S. represents the first new biologic approval in 6 years for an area where there continues to be considerable unmet need.

我們最近在美國推出的用於克羅恩病的 Skyrizi 代表了 6 年來針對該領域仍有相當大的未滿足需求的第一個新的生物批准。

We believe Skyrizi represents a highly effective and differentiated treatment option for Crohn's patients, including the potential to provide meaningful levels of endoscopic improvement with novel and infrequent dosing. Managed care access is expected to ramp strongly for this indication in the coming months.

我們相信 Skyrizi 代表了克羅恩病患者的一種高效和差異化的治療選擇，包括通過新穎和不頻繁的給藥提供有意義的內窺鏡改善水平的潛力。預計在未來幾個月內，管理式醫療服務的訪問量將強勁增長。

Turning now to Rinvoq, where we're seeing good momentum across each of the approved indications. Global sales of $592 million were up more than 27% on a sequential basis. Prescriptions and RA remained strong with a total market share of 5.8% in the U.S. and approximately 6% across key international markets.

現在轉向 Rinvoq，我們看到每個批准的適應症都有良好的勢頭。全球銷售額為 5.92 億美元，環比增長超過 27%。處方藥和 RA 保持強勁，在美國的總市場份額為 5.8%，在主要國際市場的總市場份額約為 6%。

Rinvoq is now achieving an in-play RA share of approximately 13% in the U.S. In PSA, Rinvoq continues to see nice uptick, especially in the room segment with commercial access now equal to RA. We also recently received FDA approval for ankylosing spondylitis and European approval for non-radiographic axial SpA, further expanding Rinvoq's potential across rheumatology.

Rinvoq 現在在美國實現了大約 13% 的在用 RA 份額。在 PSA 中，Rinvoq 繼續看到良好的增長，特別是在商業訪問現在等於 RA 的房間部分。我們最近還獲得了 FDA 對強直性脊柱炎的批准和歐洲對非放射軸性 SpA 的批准，進一步擴大了 Rinvoq 在風濕病領域的潛力。

In atopic dermatitis, new patient starts are tracking in line with our expectations with Rinvoq in-play patient share in the mid-teens. Strong commercial access in AD, which is also now equal to RA and PSA is expected to considerably increase paid prescription volume in this highly underpenetrated market over the remainder of the year.

在特應性皮炎中，新患者的開始跟踪符合我們的預期，Rinvoq 在場患者在青少年中的份額。 AD 中強大的商業准入，現在也等於 RA 和 PSA，預計將在今年剩餘時間內大大增加這個高度滲透市場的付費處方量。

Lastly, our recent launch of Rinvoq for ulcerative colitis in the U.S. is progressing well. and we recently just received European approval for the same indication. Commercial access in the U.S. is ramping strongly, and we are seeing, encouraging new patient starts.

最後，我們最近在美國推出的用於治療潰瘍性結腸炎的 Rinvoq 進展順利。我們最近剛剛獲得了歐洲對相同適應症的批准。美國的商業准入正在強勁增長，我們看到，鼓勵新的患者開始。

Physician feedback regarding Rinvoq's approved profile in UC has been favorable, especially given the very high rates of remission and endoscopic improvement demonstrated across our UC development program. The addressable patient population for Rinvoq in UC is substantial, with nearly 50% of patients currently on or having used TNF therapy.

醫生對 Rinvoq 在 UC 中獲得批准的資料的反饋是有利的，特別是考慮到我們的 UC 開發計劃中顯示的非常高的緩解率和內窺鏡改善率。 UC 中 Rinvoq 的可尋址患者群體很大，近 50% 的患者目前正在或曾經使用 TNF 治療。

Turning now to hematologic oncology, where total revenues were $1.65 billion, down 7.9% on an operational basis. Imbruvica global revenues were approximately $1.1 billion, down 17.1% and below our expectations. The CLL market continues to remain challenging in the U.S. with new patient starts down double digits relative to pre-pandemic levels. Now as you may recall, our initial 2022 Imbruvica sales guidance contemplated a partial market recovery, which, unfortunately, we have not yet observed in fact, the latest data reflects new patient starts in the U.S. were actually down high single digits versus last year.

現在轉向血液腫瘤學，其總收入為 16.5 億美元，在運營基礎上下降 7.9%。 Imbruvica 的全球收入約為 11 億美元，下降 17.1%，低於我們的預期。在美國，CLL 市場繼續面臨挑戰，新患者的開工率相對於大流行前水平下降了兩位數。現在，您可能還記得，我們最初的 2022 年 Imbruvica 銷售指導考慮了部分市場復甦，但不幸的是，我們實際上尚未觀察到，最新數據反映美國的新患者開始實際上與去年相比下降了高個位數。

So based on recent trends, we no longer believe it's prudent to anticipate a meaningful market recovery in CLL over the second half of this year. Therefore, we will be removing this assumption from our 2022 guidance. In addition, increasing competition from newer therapies, including other BTK inhibitors as well as our own Venclexta also continue to lower Imbruvica's share of new patient starts, especially in frontline CLL. Despite this increasing competitive pressure, Imbruvica continues to be the total market share leader across all lines of therapy in CLL.

因此，根據最近的趨勢，我們不再認為預計今年下半年 CLL 市場將出現有意義的複蘇是明智的。因此，我們將從 2022 年的指導中刪除這一假設。此外，來自新療法的競爭日益激烈，包括其他 BTK 抑製劑以及我們自己的 Venclexta，也繼續降低 Imbruvica 新患者開始的份額，特別是在一線 CLL 中。儘管競爭壓力越來越大，但 Imbruvica 仍然是 CLL 所有治療線的總市場份額領導者。

Venclexta global sales were $505 million, up 21.2% on an operational basis. In CLL, we continue to see share gains in the U.S. and across all major international markets. We're also seeing continued strong performance in AML. Venclexta is now approved in 80 countries and in many markets is already considered the new standard of care for frontline AML patients who are ineligible for intensive chemotherapy.

Venclexta 的全球銷售額為 5.05 億美元，在運營基礎上增長 21.2%。在 CLL 中，我們繼續看到美國和所有主要國際市場的份額增長。我們還看到 AML 的持續強勁表現。 Venclexta 現在已在 80 個國家獲得批准，並且在許多市場上已被視為不適合接受強化化療的一線 AML 患者的新護理標準。

As a result, we are seeing ramping market share throughout the countries where we have launched. In neuroscience, revenues were more than $1.6 billion, up 15.2% on an operational basis. Vraylar once again delivered strong growth. Sales of $492 million were up 13.9% on an operational basis reflecting continued share gains in the U.S. atypical antipsychotic market.

結果，我們看到在我們推出的國家/地區的市場份額不斷增加。在神經科學領域，收入超過 16 億美元，在運營基礎上增長 15.2%。 Vraylar 再次實現強勁增長。 4.92 億美元的銷售額在運營基礎上增長了 13.9%，反映了美國非典型抗精神病藥物市場份額的持續增長。

Our launch preparations remain well underway in anticipation of our MDD approval in the fourth quarter. This is a potentially large indication that would represent incremental upside to our current projections for Vraylar.

我們的發布準備工作仍在順利進行，預計我們將在第四季度獲得 MDD 批准。這是一個潛在的大跡象，將代表我們目前對 Vraylar 的預測的增量上升。

Within migraine, Ubrelvy remains the market-leading oral CGRP treatment for acute migraine with revenue of $185 million, up 34% on a sequential basis. QULIPTA continues to increase its leading new-to-brand share in the U.S. preventative CGRP class when we consider both paid and bridge volume. We continue to make good progress with expanded commercial access, which will support strong QULIPTA sales growth over the remainder of this year. We are also pursuing the commercial approval for QULIPTA as a preventative treatment in patients with chronic migraine in the U.S. as well as a new therapy for Europe.

在偏頭痛領域，Ubrelvy 仍然是市場領先的急性偏頭痛口服 CGRP 治療藥物，收入為 1.85 億美元，環比增長 34%。當我們考慮付費和過橋量時，QULIPTA 繼續增加其在美國預防性 CGRP 類別中領先的新品牌份額。我們繼續在擴大商業准入方面取得良好進展，這將支持 QULIPTA 在今年剩餘時間內的強勁銷售增長。我們還在尋求 QULIPTA 作為美國慢性偏頭痛患者的預防性治療以及歐洲的新療法的商業批准。

Potentially further strengthening our competitive product profile and long-term growth opportunity. BOTOX Therapeutic is also performing well in chronic migraine as well as its other indications with total sales of $678 million, up 14.5% on an operational basis. So overall, I'm pleased with the commercial execution across the therapeutic business.

有可能進一步加強我們具有競爭力的產品形象和長期增長機會。 BOTOX Therapeutic 在慢性偏頭痛及其其他適應症方面也表現良好，總銷售額為 6.78 億美元，在運營基礎上增長 14.5%。所以總的來說，我對整個治療業務的商業執行感到滿意。

Our broad portfolio of differentiated therapies and new launches is demonstrating strong revenue growth. And with that, I'll turn the call over to Tom for additional comments on our R&D programs. Tom?

我們廣泛的差異化療法和新產品組合顯示出強勁的收入增長。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, where we had several notable pipeline updates in our inflammatory bowel disease programs for both Skyrizi and Rinvoq. We recently received FDA approval for Skyrizi in Crohn's disease, and we're very pleased with the label which reflects a strong benefit risk profile that Skyrizi demonstrated as an induction and maintenance treatment for this condition.

謝謝你，傑夫。我將從免疫學開始，我們在針對 Skyrizi 和 Rinvoq 的炎症性腸病項目中進行了幾個值得注意的管道更新。我們最近獲得了 FDA 對 Skyrizi 治療克羅恩病的批准，我們對該標籤感到非常滿意，該標籤反映了 Skyrizi 作為這種疾病的誘導和維持治療所證明的強大的益處風險特徵。

Based on its profile, we believe Skyrizi will be a highly effective and differentiated treatment option for patients with Crohn's disease. Our regulatory application for Skyrizi in Crohn's disease remains under review in Europe with an approval decision expected near the end of this year.

基於其概況，我們相信 Skyrizi 將成為克羅恩病患者的一種高效且差異化的治療選擇。我們在克羅恩病中的 Skyrizi 監管申請仍在歐洲審查中，預計將在今年年底附近作出批准決定。

Also in the area of inflammatory bowel disease, we recently received European approval for Rinvoq in ulcerative colitis. And we're excited to bring this new, highly efficacious oral option to patients suffering from this often debilitating disease.

同樣在炎症性腸病領域，我們最近獲得了歐洲批准 Rinvoq 治療潰瘍性結腸炎。我們很高興為患有這種經常使人衰弱的疾病的患者帶來這種新的、高效的口服選擇。

In the quarter, we also completed a registrational program for Rinvoq in Crohn's disease, reporting positive top line results from our Phase III maintenance study. We recently submitted our regulatory applications for Rinvoq in this indication and expect approval decisions next year.

在本季度，我們還完成了 Rinvoq 在克羅恩病中的註冊計劃，報告了我們 III 期維持研究的積極頂線結果。我們最近在這個適應症中提交了我們對 Rinvoq 的監管申請，並期待明年的批准決定。

Once approved for Crohn's disease, Rinvoq will have completed development programs for all of the major rheum and gastro indications covered by HUMIRA plus atopic dermatitis. The strength of the data generated in our clinical programs should position Rinvoq as a highly differentiated treatment across this broad indication set and enable Rinvoq to deliver significant value to AbbVie over the long term.

一旦獲批用於克羅恩病，Rinvoq 將完成 HUMIRA 和特應性皮炎涵蓋的所有主要類風濕和胃腸道適應症的開發計劃。在我們的臨床項目中產生的數據的強度應該將 Rinvoq 定位為跨越這一廣泛適應症集的高度差異化的治療方法，並使 Rinvoq 能夠長期為 AbbVie 提供顯著價值。

And just this morning, we announced that we received European approval for Rinvoq in non-radiographic axial SpA which rounds out Rinvoq's label in rheumatology. Moving now to our oncology portfolio, where we continue to make excellent progress across all stages of our pipeline.

就在今天早上，我們宣布 Rinvoq 在非放射軸向 SpA 中獲得歐洲批准，這完善了 Rinvoq 在風濕病學領域的標籤。現在轉到我們的腫瘤學產品組合，我們將繼續在我們管道的所有階段取得出色進展。

At the recent EHA meeting, we presented results from the large B-cell lymphoma expansion cohort in the Phase II study evaluating epcoritamab in patients who have received at least 2 prior lines of therapy. In this study, epcoritamab was well tolerated and drove very deep and durable responses and challenging to treat highly refractory patients with large B-cell lymphoma.

在最近的 EHA 會議上，我們在 II 期研究中展示了大型 B 細胞淋巴瘤擴增隊列的結果，該研究評估了 epcoritamab 在接受過至少 2 種先前治療線的患者中的作用。在這項研究中，epcoritamab 耐受性良好，對治療高度難治性大 B 細胞淋巴瘤患者俱有非常深刻和持久的反應，具有挑戰性。

We recently discussed these results with regulatory agencies and based on the strength of the data, we intend to submit regulatory applications later this year for accelerated approval of epcoritamab in patients with relapsed/refractory large B-cell lymphoma. We expect approval decisions in 2023.

我們最近與監管機構討論了這些結果，基於數據的優勢，我們打算在今年晚些時候提交監管申請，以加速批准 epcoritamab 用於復發/難治性大 B 細胞淋巴瘤患者。我們預計將在 2023 年做出批准決定。

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(1114) mutation in the second half of this year. As a reminder, we've seen very promising results in this population in prior clinical studies with Venclexta showing high overall response rates and meaningful trends towards prolonged progression-free survival.

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(1114) 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。提醒一下，在之前的臨床研究中，我們已經在這一人群中看到了非常有希望的結果，Venclexta 顯示出較高的總體反應率和延長無進展生存期的有意義的趨勢。

The level of efficacy we've seen suggest that t(1114) patients may be particularly responsive to Venclexta and this agent has the potential to become an important biomarker-driven treatment option in the multiple myeloma market.

我們所見的療效水平表明 t(1114) 患者可能對 Venclexta 特別敏感，這種藥物有可能成為多發性骨髓瘤市場中一種重要的生物標誌物驅動的治療選擇。

In neuroscience, following successful completion of our Phase III chronic migraine prevention study, we submitted our regulatory application to the FDA for QULIPTA in chronic migraine. Chronic migraine is defined as 15 or more headache days per month with at least 8 of those days associated with migraines.

在神經科學領域，在成功完成我們的 III 期慢性偏頭痛預防研究後，我們向 FDA 提交了用於慢性偏頭痛的 QULIPTA 的監管申請。慢性偏頭痛定義為每月頭痛 15 天或以上，其中至少 8 天與偏頭痛有關。

This is a debilitating disease that affects nearly 10% of people suffering from migraine significantly impacting their quality of life. If approved, this would be another differentiating feature for QULIPTA as it would be the only oral CGRP approved for prevention in patients with chronic migraine.

這是一種使人衰弱的疾病，影響了近 10% 的偏頭痛患者，嚴重影響了他們的生活質量。如果獲得批准，這將是 QULIPTA 的另一個差異化特徵，因為它將是唯一被批准用於預防慢性偏頭痛患者的口服 CGRP。

We also submitted data from our Phase III prevention studies in both chronic and episodic migraine to support regulatory applications in markets outside the U.S. We expect approval decisions in the U.S. and in Europe in 2023. In the quarter, we submitted our regulatory application in the U.S. for ABBV-951, our novel subcutaneous levodopa carbidopa delivery system for treatment of advanced Parkinson's disease.

我們還提交了針對慢性和發作性偏頭痛的 III 期預防研究的數據，以支持在美國以外市場的監管申請。我們預計 2023 年美國和歐洲的批准決定。在本季度，我們在美國提交了監管申請。 ABBV-951，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。

This innovative delivery system has the potential to become a transformative treatment option for patients with advanced Parkinson's disease by providing Duodopa-like efficacy with less invasive nonsurgical administration.

這種創新的給藥系統有可能成為晚期帕金森病患者的一種變革性治療選擇，通過提供類似 Duodopa 的療效和侵入性較小的非手術給藥。

We also expect to submit our regulatory application in Europe later this year with approval decisions anticipated in both the U.S. and Europe in 2023.

我們還預計將於今年晚些時候在歐洲提交我們的監管申請，預計 2023 年美國和歐洲都會做出批准決定。

Now I'd like to provide a few updates on some earlier-stage programs where we have new data and our advancing programs in development.

現在我想提供一些關於我們有新數據的早期項目的更新以及我們正在開發的推進項目。

In immunology, we recently obtained encouraging data in a Phase II study evaluating Rinvoq in systemic lupus, an autoimmune multisystem disease. In our study, Rinvoq demonstrated greater response rates as well as a reduction in flares compared with placebo.

在免疫學方面，我們最近在一項評估 Rinvoq 在系統性狼瘡（一種自身免疫性多系統疾病）中的 II 期研究中獲得了令人鼓舞的數據。在我們的研究中，與安慰劑相比，Rinvoq 表現出更高的反應率以及耀斑減少。

We'll see longer-term data in the coming months, which will allow us to make a decision on moving Rinvoq into Phase III for lupus. In oncology, where we have a pipeline of promising early-stage programs aimed at solid tumors, we are beginning to see very exciting data from several programs.

我們將在未來幾個月看到更長期的數據，這將使我們能夠決定將 Rinvoq 轉移到狼瘡的 III 期。在腫瘤學領域，我們有一系列針對實體瘤的有前途的早期項目，我們開始看到來自幾個項目的非常令人興奮的數據。

Our anti-GAR antibody, ABBV-151 is designed to block the immunosuppressive activity of regulatory T cells, which leads to increased T-cell effector functions in the tumor microenvironment. This reactivates the immune system against tumors, enhancing the antitumor immune response triggered by a PD-1 inhibitor.

我們的抗 GAR 抗體 ABBV-151 旨在阻斷調節性 T 細胞的免疫抑制活性，從而提高腫瘤微環境中的 T 細胞效應功能。這會重新激活針對腫瘤的免疫系統，增強由 PD-1 抑製劑引發的抗腫瘤免疫反應。

In our Phase I program, we're combining ABBV-151 with a PD-1 checkpoint inhibitor in cancer patients who are refractory to or relapsed after a PD-1 as well as evaluating this combination in PD-1 nonresponsive tumors. Based on the preliminary efficacy we've seen in the dose expansion cohorts for multiple solid tumors, including a deepening of responses over time and prolonged durability we recently declared proof of concept for ABBV-151.

在我們的 I 期項目中，我們將 ABBV-151 與 PD-1 檢查點抑製劑聯合用於 PD-1 後難治或複發的癌症患者，並在 PD-1 無反應性腫瘤中評估這種組合。基於我們在多個實體瘤的劑量擴展隊列中看到的初步療效，包括隨著時間的推移反應加深和持久性延長，我們最近宣布 ABBV-151 的概念證明。

We plan to advance to Phase II in several solid tumors, starting with urothelial cancer, we're also expecting additional data readouts later this year in other solid tumor indications, including colorectal cancer, which may enable further expansion studies in this hard-to-treat cancer type.

我們計劃在幾個實體瘤中推進到 II 期，從尿路上皮癌開始，我們還期待今年晚些時候在其他實體瘤適應症（包括結直腸癌）中獲得更多數據讀數，這可能會在這個難以實現的領域進行進一步的擴展研究。治療癌症類型。

We will also begin new studies to explore a broader set of solid tumors where GARP is implicated as a critical immunosuppressive pathway based on tumor tissue analyses. We're also making excellent progress with our next-generation cMet ADC ABBV-400 where the emerging clinical data is very promising in several solid tumors.

我們還將開始新的研究，以探索更廣泛的實體瘤，其中 GARP 被認為是基於腫瘤組織分析的關鍵免疫抑制途徑。我們的下一代 cMet ADC ABBV-400 也取得了出色的進展，其中新興的臨床數據在幾種實體瘤中非常有希望。

This asset is similar to Teliso-V a cMeT ADC that uses a microtubulin inhibitor payload. Teliso-V received breakthrough therapy designation for the treatment of patients with a subtype of lung cancer with high levels of cMet overexpression.

該資產類似於使用微管蛋白抑製劑有效載荷的 cMeT ADC Teliso-V。 Teliso-V 獲得了突破性療法認定，用於治療具有高水平 cMet 過表達的肺癌亞型患者。

The toxin warhead for ABBV-400 uses a more potent topoisomerase inhibitor payload, which is similar to irinotecan, a chemotherapy that is used in the treatment of colorectal cancer. By targeting cMeT-positive tumors with ADCs bearing different warheads we believe we can broaden the range of solid tumors where cMet therapies can be used.

ABBV-400 的毒素彈頭使用更有效的拓撲異構酶抑製劑有效載荷，類似於用於治療結腸直腸癌的化療藥物伊立替康。通過使用帶有不同彈頭的 ADC 靶向 cMeT 陽性腫瘤，我們相信我們可以擴大可以使用 cMet 療法的實體瘤的範圍。

In our Phase I program, we are seeing good responses in patients with advanced colorectal cancer and remain encouraged by these early efficacy signals. So in summary, we've seen tremendous progress across all stages of our pipeline in the first half of the year, and we remain on track for further advancements in the remainder of 2022.

在我們的 I 期項目中，我們看到晚期結直腸癌患者的良好反應，並繼續受到這些早期療效信號的鼓舞。總而言之，我們在今年上半年在管道的所有階段都取得了巨大進展，我們仍有望在 2022 年剩餘時間內取得進一步進展。

So with that, I'll turn the call over to Rob for additional comments on our second quarter performance and financial outlook. Rob?

因此，我將把電話轉給 Rob，以徵求對我們第二季度業績和財務前景的更多評論。搶？

Thank you, Tom. AbbVie's second quarter results demonstrate the strength of our diversified portfolio. Momentum from new products and recently launched indications allows us to maintain our earnings outlook despite market dynamics for Imbruvica, higher inflation and the stronger U.S. dollar.

謝謝你，湯姆。艾伯維第二季度的業績證明了我們多元化投資組合的實力。儘管 Imbruvica 的市場動態、通脹上升和美元走強，新產品的勢頭和最近推出的跡象使我們能夠維持盈利前景。

We reported adjusted earnings per share of $3.37, reflecting growth of 11.2% compared to prior year and $0.11 above our guidance midpoint. These results include a $0.14 unfavorable impact from acquired IPR&D expense.

我們報告調整後的每股收益為 3.37 美元，與去年相比增長 11.2%，比我們的指導中點高 0.11 美元。這些結果包括從獲得的 IPR&D 費用中產生的 0.14 美元的不利影響。

Total net revenues were $14.6 billion, up 6.1% on an operational basis, excluding a 1.6% unfavorable impact from foreign exchange. The adjusted operating margin ratio was 51% of sales, an improvement of 220 basis points versus the prior year.

總淨收入為 146 億美元，在運營基礎上增長 6.1%，不包括外匯帶來的 1.6% 的不利影響。調整後的營業利潤率為銷售額的 51%，比上一年提高了 220 個基點。

This includes adjusted gross margin of 84.7% of sales, adjusted R&D investment of 11% of sales, acquired IPR&D expense of 1.8% of sales and adjusted SG&A expense of 20.8% of sales.

這包括調整後的毛利率佔銷售額的 84.7%，調整後的研發投資佔銷售額的 11%，獲得的 IPR&D 費用佔銷售額的 1.8%，調整後的 SG&A 費用佔銷售額的 20.8%。

Net interest expense was $532 million, and the adjusted tax rate was 13.4%. Turning to our financial outlook. We are confirming our full year adjusted earnings per share guidance between $13.78 and $13.98. This earnings per share guidance does not include an estimate for acquired IPR&D expense that may be incurred beyond the second quarter.

淨利息支出為 5.32 億美元，調整後的稅率為 13.4%。轉向我們的財務前景。我們確認我們的全年調整後每股收益指引在 13.78 美元至 13.98 美元之間。該每股收益指引不包括對可能在第二季度之後發生的已收購 IPR&D 費用的估計。

We now expect net revenues of approximately $58.9 billion, reflecting growth of 6.5% on an operational basis. At current rates, we expect foreign exchange to have a 1.7% unfavorable impact on full year sales growth.

我們現在預計淨收入約為 589 億美元，在運營基礎上增長 6.5%。按照目前的匯率，我們預計外匯將對全年銷售增長產生 1.7% 的不利影響。

Included in this guidance are the following updated assumptions. We now expect Skyrizi global sales of approximately $4.8 billion, an increase of $400 million due to strong market share performance. For Imbruvica, we now expect global revenue of approximately $4.7 billion, given the lack of recovery in the CLL market and increasing competition.

本指南中包括以下更新的假設。我們現在預計 Skyrizi 的全球銷售額約為 48 億美元，由於強勁的市場份額表現，增加了 4 億美元。鑑於 CLL 市場缺乏復甦和日益激烈的競爭，我們現在預計 Imbruvica 的全球收入約為 47 億美元。

Moving to the P&L we now expect adjusted gross margin of 84.7% of sales and continue to forecast an adjusted operating margin ratio of 51.8% of sales. Turning to the third quarter. We anticipate net revenues of approximately $14.8 billion.

轉向損益表，我們現在預計調整後的毛利率為銷售額的 84.7%，並繼續預測調整後的營業利潤率為銷售額的 51.8%。轉眼到第三季。我們預計淨收入約為 148 億美元。

At current rates, we expect foreign exchange to have a 2.1% unfavorable impact on sales growth. We expect adjusted earnings per share between $3.55 and $3.59. This guidance does not include acquired IPR&D expense that may be incurred in the quarter.

按照目前的匯率，我們預計外匯將對銷售增長產生 2.1% 的不利影響。我們預計調整後的每股收益在 3.55 美元至 3.59 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 delivered strong performance again this quarter, including meaningful contributions from new products and recently launched indications. Given the momentum of our business as well as our pipeline advancements, we are well positioned for the long term. With that, I'll turn the call back over to Liz.

最後，我們在本季度再次取得了強勁的業績，包括來自新產品和最近推出的跡象的有意義的貢獻。鑑於我們業務的勢頭以及我們的管道進步，我們在長期內處於有利地位。有了這個，我會把電話轉回給 Liz。

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

謝謝，羅伯。我們現在將打開問題的電話。為了在電話會議的剩餘時間裡盡可能多地聽取分析師的意見，我們要求您將問題限制在 1 或 2 個。接線員，我們將回答第一個問題。

Our first question is Andrew Baum, Citi.

我們的第一個問題是花旗銀行的 Andrew Baum。

First question is on the guidance range you've given for anticipated trajectory of HUMIRA in the U.S. presumably you're finishing contracting, both with Medicare and commercial, could you provide any guidance further on '23 and even '24 (inaudible) 2-year contracts?

第一個問題是關於您為 HUMIRA 在美國的預期軌跡給出的指導範圍，大概您正在完成與 Medicare 和商業的合同，您能否在 23 年甚至 24 年（聽不清）提供任何進一步的指導 2-年合同？

And then second, a pipeline question in relation to your anti-GARP monoclonal, which you've taken a long time to sort of optimize or move forward. I'm just curious whether you're using any molecular markers in order to minimize risk given the failures of other TGF beta targeted agents, particularly in colorectal using CMS 4 or a subgroup of the total population?

其次，關於您的抗 GARP 單克隆抗體的管道問題，您已經花了很長時間來優化或推進。我只是好奇，鑑於其他 TGF beta 靶向藥物的失敗，特別是在使用 CMS 4 或總人口亞組的結直腸癌中，您是否正在使用任何分子標記物來最大限度地降低風險？

Or are you putting it in new comers. There is a suggestion it (inaudible) again informed biomarkers?

或者你把它放在新來的人身上。有一個建議它（聽不清）再次告知生物標誌物？

Okay. Andrew, this is Rick. Thank you for the questions. I'll cover the first one, and then Tom can cover the second one. So we are in the process now, as we've indicated before, of negotiating with the managed care organizations and the PBMs to establish our contract position for Humira in 2023.

好的。安德魯，這是瑞克。謝謝你的提問。我會介紹第一個，然後湯姆可以介紹第二個。因此，正如我們之前所指出的，我們現在正處於與管理式醫療組織和 PBM 談判的過程中，以確定我們在 2023 年與 Humira 的合同位置。

This has been a normal time that you would go through that. It is progressing as we would expect. I would say we're midway through that process right now. I would expect it to conclude near the end of the third quarter, early of the fourth quarter. At that point, that's an important part of refining our model for 2023 in particular.

這是你會經歷的正常時期。正如我們所期望的那樣，它正在取得進展。我想說我們現在正處於這個過程的中途。我預計它將在第三季度末，第四季度初結束。在這一點上，這尤其是完善我們的 2023 年模型的重要部分。

And what that will tell us is that the positions that we have formulary status for 2023 in for Humira, and that will help us define clearly the volume aspect of it. And so that's going well, and that's going to be an important part of us being able to refine that model.

這將告訴我們的是，我們在 Humira 中擁有 2023 年處方狀態的位置，這將有助於我們清楚地定義它的數量方面。所以進展順利，這將成為我們能夠完善該模型的重要部分。

And so as we get further along in that process, that will give us the ability to be able to potentially refine the model that we have. Now the one thing that's important to remember in all of this is price is the other key aspect here.

因此，隨著我們在這個過程中走得更遠，這將使我們能夠潛在地改進我們擁有的模型。現在，在所有這一切中要記住的重要一件事是價格，這是這裡的另一個關鍵方面。

And there, we won't know real pricing until the actual event starts to occur. So we will make assumptions around what that price looks like. And I think those will be informed assumptions, but they are just at their assumptions. And so that's the 1 piece that will still be somewhat of an unknown until we see the landscape start to play out in 2023.

在那裡，在實際事件開始發生之前，我們不會知道實際定價。因此，我們將圍繞該價格的樣子做出假設。我認為這些都是有根據的假設，但它們只是在他們的假設上。因此，在我們看到 2023 年景觀開始上演之前，這仍然是一個未知數。

And particularly in midway through 2023 when more biosimilars enter the market. So as we get more information, we can provide more clarity, we'll certainly try to do that, but I think that's where we are right now. Tom?

特別是在 2023 年中期，更多的生物仿製藥進入市場。因此，隨著我們獲得更多信息，我們可以提供更清晰的信息，我們當然會嘗試這樣做，但我認為這就是我們現在所處的位置。湯姆?

Andrew, I'll try to break down the question in different parts because you're right, there are many TGF-beta assets. This one is unique GARP. Most of the TGF beta assets work either antibodies against receptors to the active form of TGF-beta or TGF-beta itself that's in circulation on cells. But GARP blocks the inactive form of TGF-beta before it's released from TGF-beta. And we believe that actually is a differentiated mechanism also that allows that specificity to what's happening in TGF-beta in the tumor as opposed to other systems in the body. At the beginning of this, we thought we had already had people that published that there are very good TGF-beta signatures that exist.

安德魯，我將嘗試在不同的部分分解這個問題，因為你是對的，有很多 TGF-beta 資產。這是一個獨特的 GARP。大多數 TGF-beta 資產要么是針對 TGF-beta 活性形式的受體的抗體，要么是在細胞上循環的 TGF-beta 本身。但 GARP 在 TGF-beta 釋放之前阻斷了 TGF-beta 的非活性形式。我們相信這實際上是一種差異化的機制，它允許對腫瘤中 TGF-β 中發生的事情的特異性，而不是身體中的其他系統。在這開始時，我們認為我們已經有人發表過存在非常好的 TGF-beta 特徵。

And I can tell you that GARP signature follows tracks with TGF-beta signatures. And that's often seen in all solid tumors or susceptive tumors that express these pathways. It's a very common immunosuppressive mechanism. That's why people and us are interested in it.

我可以告訴你，GARP 簽名遵循 TGF-beta 簽名的軌跡。這在所有表達這些途徑的實體瘤或易感腫瘤中都很常見。這是一種非常常見的免疫抑制機制。這就是人們和我們對它感興趣的原因。

We learned -- initially, from data, we kind of suspected that people who actually had a nice hot tumors, but we're not responding to PD-1s often had, at least from published work actually had a higher TGF-beta signature.

我們了解到——最初，從數據中，我們有點懷疑那些實際上有很好的熱腫瘤但我們對 PD-1 沒有反應的人通常有，至少從已發表的工作中實際上有更高的 TGF-β 特徵。

So we thought that was a reason to mechanism why these patients with hot tumors were not responding and a lot of our initial clinical strategy there was actually to go after hot tumors where PD-1s had relapsed or refractory.

所以我們認為這是解釋為什麼這些熱腫瘤患者沒有反應的原因，我們最初的許多臨床策略實際上是針對 PD-1 復發或難治的熱腫瘤。

And we thought we could augment the PD-1 checkpoint response by doing this combination. We did not see monotherapy activity, but in combination, we did. And that's why our first data sets and expansions like I've just discussed in urothelial cancer, this project started earlier, we're seeing data that's suggesting that this is correct that you need to flex both the pathway of TGF Beta and PD-1, to get a response.

我們認為我們可以通過這種組合來增強 PD-1 檢查點響應。我們沒有看到單一療法的活動，但結合起來，我們看到了。這就是為什麼我們的第一個數據集和擴展，就像我剛剛在尿路上皮癌中討論的那樣，這個項目開始得更早，我們看到的數據表明這是正確的，你需要同時調整 TGF Beta 和 PD-1 的途徑, 得到回應。

And those, again, in multiple tumor types we're seeing these responses and we're moving forward. At the same time, if we could bring it to colon, we could also see the same signatures of TGF-beta and GARP in cold tumors, but we weren't sure that since they're not IO-responsive, whether we'd get a response -- we would get a clinical response.

同樣，在多種腫瘤類型中，我們看到了這些反應，我們正在向前邁進。同時，如果我們能把它帶到結腸，我們也可以在冷腫瘤中看到相同的 TGF-β 和 GARP 特徵，但我們不確定因為它們對 IO 沒有反應，我們是否會得到回應——我們會得到臨床回應。

But we did start some investigations. And yes, we did see some responses in cold tumors. They happen over time, (inaudible) sometimes it appear the tumors are stable for 3 months, maybe 6 months. And then you see these responses appear.

但我們確實開始了一些調查。是的，我們確實在冷腫瘤中看到了一些反應。它們會隨著時間的推移而發生，（聽不清）有時腫瘤似乎穩定了 3 個月，也許 6 個月。然後你會看到這些響應出現。

They're very durable, 1 year, 2 year. Very unusual. These are patients with advanced disease that have very poor prognosis in Phase I studies, so we saw some, I would say -- we sometimes say in academic column exceptional responders. And so we decided to expand.

它們非常耐用，1 年，2 年。很不尋常。這些是在 I 期研究中預後非常差的晚期疾病患者，所以我們看到了一些，我想說 - 我們有時在學術專欄中說特殊反應者。所以我們決定擴大。

So those data sets are newer, are happening right now. I probably will have the data at the end of this year. But yes, we've seen -- we've seen responses to this combination. And to answer your question. So the signatures we're looking at are not the CMS or kind of histology-based signatures on the tumor. It's more signatures of the inflammatory response that we can measure in the tumor, and it has to do with both inflammatory T cells, which are there for the killing, but also the inhibitory TGF-beta signatures.

所以這些數據集是更新的，現在正在發生。我可能會在今年年底得到數據。但是，是的，我們已經看到了——我們已經看到了對這種組合的反應。並回答你的問題。因此，我們正在查看的特徵不是腫瘤上的 CMS 或基於組織學的特徵。我們可以在腫瘤中測量更多的炎症反應特徵，它與用於殺傷的炎症 T 細胞以及抑制性 TGF-β 特徵有關。

And of course, we're going to continue to investigate this. I don't have all the answers for you today, but it certainly has been exciting to see how this program has evolved.

當然，我們將繼續對此進行調查。今天我並沒有給你所有的答案，但是看到這個程序是如何演變的，肯定是令人興奮的。

Thanks, Andrew.

謝謝，安德魯。

Our next question is Terence Flynn with Morgan Stanley.

我們的下一個問題是摩根士丹利的特倫斯弗林。

Maybe 2 for me. Just wanted to make sure that you are maintaining your 2022 Aesthetics guidance of $5.9 billion. Rob, I didn't hear you call it out, so I'm assuming that was a reiteration, just given what you're seeing with Juvederm's in the U.S.

對我來說可能是 2 個。只是想確保您維持 59 億美元的 2022 年美學指導。 Rob，我沒有聽到你說出來，所以我假設這是一個重申，只是考慮到你在美國看到的 Juvederm's

And then the second question I had relates more of a, I guess, strategic one, Rick. I know you're still going through the conversations with 2023 for Humira. But as you think about providing an update to guidance, whether that happens with the 3Q results or with the 4Q results, do you think you'll be able to provide some outlook on 2024 because I think something investors are discussing now is just if the possibility of the impact is more in '24, how we should think about revenue margins in '24 versus '23.

然後我提出的第二個問題更多地涉及一個，我想，戰略問題，里克。我知道您仍在為 Humira 與 2023 進行對話。但是，當您考慮提供指導更新時，無論是第三季度業績還是第四季度業績，您是否認為您能夠提供 2024 年的一些展望，因為我認為投資者現在正在討論的事情是24 年影響的可能性更大，我們應該如何考慮 24 年和 23 年的收入利潤率。

So just wondering strategically how you're thinking about that at this point, not asking for guidance, more just thought process.

所以只是從戰略上想知道你在這一點上是如何考慮的，而不是尋求指導，更多的是思考過程。

So Terence, I'll take both of those questions, and then Rob can certainly jump in here if he has something he wants to add. We are maintaining the Aesthetics guidance as we've indicated. Certainly, we have seen good, strong performance on the toxin side of the business, and we would expect it to continue.

所以特倫斯，我會回答這兩個問題，然後如果羅伯有他想補充的東西，他當然可以跳到這裡來。正如我們所指出的，我們正在維護美學指導。當然，我們已經看到該業務在毒素方面的良好、強勁表現，我們預計它會繼續下去。

As we look at the filler side of the business, as you've noted, it was lighter this quarter than we've seen historically. And I'd say that was driven by a couple of issues. It was certainly driven by the China Russia issue outside the U.S. In the U.S., we did have a very successful promotional program that we ran last year. So it was a tough comparison versus last year. But I'd also say we have seen some glimpses of what could be inflationary pressure on that business or it could be pent-up demand for vacations.

正如您所指出的，當我們查看業務的填充方面時，本季度的情況比我們歷史上看到的要輕。我會說這是由幾個問題驅動的。這當然是由美國以外的中俄問題推動的。在美國，我們去年確實有一個非常成功的促銷計劃。因此，與去年相比，這是一個艱難的比較。但我還要說，我們已經看到了一些可能對該業務造成通脹壓力的情況，或者可能是被壓抑的假期需求。

And Carrie can certainly go through in more detail if there's a follow-up question. But I think as we look at the business overall, we're comfortable maintaining the guidance now. We believe that BOTOX will continue to perform very well. And obviously, we're doing more things to be able to drive the toxin side of the business. It's at a price point where it should be less sensitive to inflationary pressures. The price point for toxin is about $500, I think, right, Gary. And where fillers are almost twice that or maybe even a little more than twice that. So clearly, from a disposable income standpoint, fillers are more challenging for people than toxins are and so that's the rationale behind it.

如果有後續問題，嘉莉當然可以更詳細地討論。但我認為，當我們審視整個業務時，我們現在可以放心地維持指導。我們相信 BOTOX 將繼續表現出色。顯然，我們正在做更多的事情來推動業務的毒素方面。它的價格點應該對通脹壓力不那麼敏感。毒素的價格大約是 500 美元，我想，對，加里。填充物幾乎是它的兩倍，甚至可能是它的兩倍多一點。很明顯，從可支配收入的角度來看，填充物對人們來說比毒素更具挑戰性，這就是它背後的理由。

And certainly, as we look at the overall performance of the AbbVie business, we have plenty of opportunities with the diversity of our portfolio to cover any potential shortfall if we ended up having an issue at all. So that's why we're comfortable maintaining the guidance. And I think we need to see more time playout here to see exactly where we are from a U.S. inflationary impact.

當然，當我們審視 AbbVie 業務的整體表現時，如果我們最終遇到問題，我們有很多機會利用我們的投資組合的多樣性來彌補任何潛在的不足。所以這就是為什麼我們很樂意維護指導。而且我認為我們需要在這裡看到更多的時間播出，以確切地了解我們在美國通脹影響中所處的位置。

On the second question, as it relates to an update on '23 and potentially something on '24. I think the way you've described it is accurate. When we have more information we'll try to provide that. And when we've gotten to a point that certainly by the fourth quarter call, we're going to provide you guidance on what we think will happen in 2023. But if we can provide something on the third quarter call, I wouldn't be looking for guidance. I think that's not a good expectation. But certainly, potentially a little more clarification on what our contracting status looks like at that point and how that will translate into what we think. And if we can refine the model to a greater degree, we would certainly provide that.

關於第二個問題，因為它與 '23 的更新以及 '24 的更新有關。我認為你描述的方式是準確的。當我們有更多信息時，我們會盡力提供。當我們確定到第四季度電話會議時，我們將為您提供我們認為 2023 年會發生什麼的指導。但如果我們可以在第三季度電話會議上提供一些東西，我不會正在尋求指導。我認為這不是一個好的期望。但可以肯定的是，我們可能會進一步澄清當時我們的合同狀態是什麼樣的，以及這將如何轉化為我們的想法。如果我們可以在更大程度上改進模型，我們當然會提供。

As it relates to 2024, certainly, I'm not going to -- we're not in a position we're going to talk about 2024 right now. And I think that would be a little bit unlikely because not all these contracts will be 2-year contracts. And so you really won't know what your volume position is at that point. And as I said, you won't know what the pricing is going to be particularly midway through the year. And so I think those will be important things to be able to dial in to where the forecast is going. I say, overall, we feel good about the contracting position that we're in.

因為它與 2024 年有關，我當然不會——我們現在還不能談論 2024 年。而且我認為這不太可能，因為並非所有這些合同都是 2 年期合同。所以你真的不知道那時你的音量位置是什麼。正如我所說，你不會知道今年年中的定價會是多少。因此，我認為這些將是重要的事情，以便能夠撥入預測的走向。我說，總的來說，我們對我們所處的合同位置感覺很好。

And then I'd say the other thing is, I know investors really want to try to model this between '23 and '24. I understand why you want to do that. Certainly, we obviously would like to do that to the greatest degree possible.

然後我要說另一件事是，我知道投資者真的想嘗試在 23 年和 24 年之間進行建模。我明白你為什麼要這樣做。當然，我們顯然希望盡最大可能做到這一點。

But when you step back and you actually look at the performance of AbbVie and how you will value AbbVie and where AbbVie moves going forward. It has relatively little to do with Humira and that shape of that curve between '23 and '24. And certainly, by the end of '24, we should reach a point where we've achieved some level of stability on the tail of Humira.

但是，當您退後一步，您會真正看到 AbbVie 的表現，以及您將如何評價 AbbVie 以及 AbbVie 未來的發展方向。它與 Humira 以及 '23 和 '24 之間的曲線形狀關係不大。當然，到 24 年底，我們應該達到在 Humira 的尾部實現某種程度的穩定性的地步。

What AbbVie is all about is these other products like Skyrizi and Rinvoq and Vraylar and (inaudible), the Aesthetics business, QLEPTA, those are going to be the things that drive it. So if you want to focus on something and it's what we focus on internally is that underlying growth engine that will emerge on the other side of whatever erosion Humira ends up suffering before it hit some level of stability and tail is those assets and then what it comes out of the pipeline. Those are the key things that are going to create that growth between 25% and 30%.

艾伯維的全部內容是 Skyrizi、Rinvoq 和 Vraylar 等其他產品，以及（聽不清）美學業務 QLEPTA，這些將成為推動它的因素。因此，如果您想專注於某件事，而我們內部關注的是潛在的增長引擎，它將出現在任何侵蝕的另一邊，Humira 在達到某種程度的穩定之前最終會遭受痛苦，而尾巴就是這些資產，然後是什麼從管道中出來。這些是將創造 25% 到 30% 之間增長的關鍵因素。

And that's the part that we -- I would say, we're obviously managing Humira to the greatest extent we can. But that's the part that we as a team are focusing on and I think that's the most important part because that is the AbbVie going forward.

這就是我們 - 我會說，我們顯然正在盡最大努力管理 Humira。但這是我們作為一個團隊關注的部分，我認為這是最重要的部分，因為這是 AbbVie 的未來。

Thanks, Terence.

謝謝，特倫斯。

Our next question is Mohit Bansal with Wells Fargo.

我們的下一個問題是富國銀行的 Mohit Bansal。

Maybe dwelling a little bit more on the Humira question for Rick and Jeff. So you said that pricing from the competition will be key unknown for next year. So as you get into contracts this year, for the next year, how rigid or flexible these contracts are from the pricing point of view, when PBMs realize that the biosimilar is giving an X or Y pricing? Or would that be more of a 2024 issue rather than 2023?

也許更多地關注 Rick 和 Jeff 的 Humira 問題。所以你說競爭定價將是明年的關鍵未知數。因此，當您今年簽訂合同時，明年，當 PBM 意識到生物仿製藥給出 X 或 Y 定價時，從定價的角度來看，這些合同的剛性或靈活性如何？或者這更像是 2024 年的問題而不是 2023 年的問題？

Well, let me take a shot at that, certainly, Jeff is closer to it. So Jeff, if you want to add anything in, feel free to jump in and add. Typically, new contracts for an asset like Humira, you're contracting for a formulary position.

好吧，讓我試一試，當然，傑夫更接近它。因此，傑夫，如果您想添加任何內容，請隨時加入並添加。通常，對於像 Humira 這樣的資產的新合同，您是在為一個公式頭寸簽訂合同。

And there are volume requirements or other kinds of requirements. I think it's also -- it would be prudent to assume that biosimilars will be on these contracts whether it's one or more than one that will coexist with Humira. So price plays an important role in that because they will coexist.

並且有數量要求或其他類型的要求。我認為這也是——謹慎的做法是假設生物仿製藥將出現在這些合同中，無論是一種還是多種與 Humira 共存的產品。因此，價格在其中起著重要作用，因為它們將共存。

And so I'd say -- and as that becomes fluid, you would have to make decisions around how you try to deal with that. To maintain the kinds of volumes that you want to maintain. And we've said all along, the strategy that we'll have in the U.S. in similar to the strategy that we had internationally and that is maintain as much volume as we can at the highest level of profit that we can maintain it at.

所以我會說——隨著情況變得不穩定，你將不得不圍繞如何處理它做出決定。維護您想要維護的各種卷。我們一直在說，我們在美國的戰略類似於我們在國際上的戰略，那就是在我們可以維持的最高利潤水平上保持盡可能多的銷量。

And that is the logic that we will employ. But that doesn't mean we won't have to be somewhat responsive to prices in the marketplace on Humira. Jeff, anything you'd add?

這就是我們將採用的邏輯。但這並不意味著我們不必對 Humira 市場上的價格有所反應。傑夫，你有什麼要補充的嗎？

No, I think that's -- Rick, that's a very reasonable way to look at it in terms of how these negotiations are going and how we see '23 playing out. I mean the real big ones in terms of how we look at it is the 2 big scenarios are, you are likely coexisting with one or more biosimilars or if the negotiations don't go the way that we anticipate that were excluded in favor of biosimilars. And that's basically where price and volume in terms of refining our model, for '23. That's the work that we're doing over the summer and then into the fall.

不，我認為那是——里克，從這些談判的進展情況以及我們如何看待 23 年的結果來看，這是一個非常合理的方式來看待它。我的意思是，就我們如何看待它而言，真正的大事件是兩個大場景，您可能會與一種或多種生物仿製藥共存，或者如果談判沒有按照我們預期的方式進行，這些生物仿製藥被排除在外.這基本上就是 23 年改進我們模型的價格和數量。這就是我們在夏天和秋天所做的工作。

Next question is Gary Nachman with BMO Capital Markets.

下一個問題是 BMO Capital Markets 的 Gary Nachman。

So Skyrizi was very strong in the second quarter, and you raised guidance nicely. How much of a benefit are you getting from the psoriatic arthritis indication thus far? What are you expecting Crohn's to contribute this year? How much are those playing into the raised guidance?

所以 Skyrizi 在第二季度非常強大，你很好地提出了指導。到目前為止，您從銀屑病關節炎適應症中獲得了多少好處？你期望克羅恩今年做出什麼貢獻？那些參與提出的指導的人有多少？

And are you revisiting the long-term guidance on Skyrizi at this point given the strong performance? And then just on the hem/onc franchise. Are you keeping the infrastructure intact preparing for new products to contribute? And maybe you could talk about the near-term opportunities you see for products like epcoritamab and navitoclax, how much of those could contribute and potentially offset some of the pressure you've been seeing from Imbruvica?

鑑於強勁的表現，您是否正在重新審視 Skyrizi 的長期指導？然後就在 hem/onc 特許經營權上。您是否保持基礎設施完好無損，為新產品的貢獻做準備？也許你可以談談你看到的 epcoritamab 和 navitoclax 等產品的近期機會，其中有多少可以貢獻並可能抵消你從 Imbruvica 看到的一些壓力？

Yes. Thank you. It's Jeff. Thanks for the question. So your instinct and observation is right. The big dynamic change for Skyrizi here, largely what you're seeing is from the psoriatic arthritis indication. And obviously saw very, very large sequential moves. And let me give you some sense of what we're looking at.

是的。謝謝你。是傑夫。謝謝你的問題。所以你的直覺和觀察是對的。 Skyrizi 的巨大動態變化，主要是您所看到的來自銀屑病關節炎的適應症。並且顯然看到了非常非常大的連續動作。讓我讓你了解一下我們在看什麼。

So we're seeing that we're putting more and more basically headroom into the overall share position first in psoriatic disease, so that's psoriasis plus PSA. So we're at 26% in terms of total TRx share and moving very, very nicely up. So that's being driven by this PSA acceleration.

因此，我們看到我們在銀屑病疾病中將越來越多的基本空間放在整體份額位置上，這就是銀屑病加 PSA。因此，我們的總 TRx 份額為 26%，並且非常非常好地上升。所以這是由這種 PSA 加速推動的。

So first, remember that the PSA indication, we were the -- really the last large product that didn't have that indication. So first, what happens is it starts to interact very positively in the dermatology segment. So as I mentioned, about 30% of patients both have skin and joint involvement -- and so we actually had a lower despite the fact that we had the leading psoriasis share, we had a lower psoriasis share because we weren't covered with the joints with that indication.

因此，首先，請記住 PSA 指示，我們是 - 實際上是最後一個沒有該指示的大型產品。因此，首先，它開始在皮膚科領域產生非常積極的影響。正如我所提到的，大約 30% 的患者都有皮膚和關節受累——儘管事實上我們擁有領先的銀屑病份額，但實際上我們的銀屑病份額較低，我們的銀屑病份額較低，因為我們沒有被覆蓋具有該指示的關節。

So you see an immediate, very rapid acceleration of our overall derm business that I highlighted. Secondly, strategically important to the performance is that we're able to launch the PSA indication for Skyrizi in rheumatology. So it starts to work together with the Rinvoq PSA indication, and the Rheum segment is 3x as large as the Derm segment.

因此，您會看到我強調的我們整體皮膚業務的立即、非常快速的加速。其次，對業績具有戰略意義的是，我們能夠為 Skyrizi 推出風濕病學的 PSA 適應症。所以它開始與 Rinvoq PSA 適應症一起工作，大黃段是真皮段的 3 倍。

So it's a very, very good dynamic in terms of our momentum in 2 large segments even before we get to Crohn's. Now I would say that as we've talked about before, I mean, Skyrizi is a very special product, very unique dosing, very stable, incredible efficacy and so we are encouraged on the early results of Crohn's.

因此，即使在我們到達克羅恩病之前，就我們在兩大細分市場的勢頭而言，這是一個非常非常好的動態。現在我想說，正如我們之前談到的，我的意思是，Skyrizi 是一種非常特殊的產品，非常獨特的劑量，非常穩定，令人難以置信的功效，因此我們對克羅恩病的早期結果感到鼓舞。

It's too early to start to see what numbers are, et cetera. But all of that is playing into the raise that Rob talked about.

現在開始看數字是什麼還為時過早，等等。但所有這些都在 Rob 談到的加註中發揮作用。

And Gary, this is Rob. Just on the guidance. So if you recall earlier in the year, we got asked the question, I said PSA for Skyrizi was going to contribute about $200 million this year. It's probably closer to $400 million now with the guidance range given the very nice uptick we've seen in PSA.

加里，這是羅伯。就在指導上。所以如果你記得今年早些時候，我們被問到一個問題，我說 Skyrizi 的 PSA 今年將貢獻約 2 億美元。鑑於我們在 PSA 看到的非常好的上漲，現在可能接近 4 億美元的指導範圍。

But part of that guidance raise is also the strong share performance in psoriasis. So it includes both. In terms of Crohn's, that hasn't changed. We've set approximately $100 million this year as we ramp access for Crohn's. But obviously, the long-term potential for it is tremendous, and we're very excited about that.

但該指導性提高的一部分也是牛皮癬的強勁股票表現。所以它包括兩者。就克羅恩而言，這並沒有改變。今年我們已經為克羅恩病增加了大約 1 億美元的資金。但顯然，它的長期潛力是巨大的，我們對此感到非常興奮。

And maybe I can also then chime in on the second question. Certainly, that is a -- the new assets are a very important part of our growth story for hem/onc. Certainly, as I mentioned, we're still continuing to ramp around the world with CLL. We have more and more impressive data, particularly in the unfit frontline population, we have 5 years of data in the fit population for frontline for Venclexta. We're encouraged with the myeloma data, which is very unique in terms of biomarker driven approach for the t (1114), Navitoclax would be really one of the first new entrants for myelofibrosis, where there's really only been [RUX] in terms of that market.

也許我也可以插話第二個問題。當然，這是 - 新資產是我們 hem/onc 增長故事中非常重要的一部分。當然，正如我所提到的，我們仍在繼續使用 CLL 在全球範圍內推廣。我們有越來越多令人印象深刻的數據，特別是在不適合的一線人群中，我們在適合 Venclexta 的一線人群中有 5 年的數據。我們對骨髓瘤數據感到鼓舞，這在 t (1114) 的生物標誌物驅動方法方面非常獨特，Navitoclax 確實是骨髓纖維化的首批新進入者之一，就那個市場。

Epcoritamab, increasingly encouraging data in terms of the simple subcu very rapid ways to get this medication in later lines and then building into frontline. So we are very, very encouraged while we see some pressure on Imbruvica the new indications in base for Venclexta helps to offset that.

Epcoritamab，在簡單的 subcu 非常快速的方法方面越來越令人鼓舞的數據，可以在後期生產這種藥物，然後進入一線。因此，當我們看到 Imbruvica 面臨一些壓力時，我們感到非常非常鼓舞，Venclexta 基礎的新跡像有助於抵消這種壓力。

And then we start to build with those near-term heme assets and super encouraged in terms of what we're seeing in terms of the probability that we can get there.

然後我們開始使用那些近期的血紅素資產進行構建，並且就我們所看到的我們能夠到達那裡的可能性而言，我們感到非常鼓舞。

Our next question is from Chris Schott J.P. Morgan.

我們的下一個問題來自 Chris Schott J.P. Morgan。

First one, I just wanted to come back to dynamics on the U.S. dermal filler market. I guess specifically, can you just quantify how much of the weakness we saw this -- or the decline year-over-year was due to the promotion events last year versus the impact from the economic pressures that you're seeing?

第一個，我只是想回到美國真皮填充劑市場的動態。我想具體來說，您能否量化一下我們看到的這種疲軟 - 或者同比下降是由於去年的促銷活動與您所看到的經濟壓力的影響？

And I guess in the same context, are you seeing any signs of weakness in the European business? And just and we're just trying get your hands around what type of magnitude of impact you're talking about here in terms of either its inflation or economic sensitivity to that business.

我猜在同樣的背景下，您是否看到歐洲業務有任何疲軟跡象？只是，我們只是想了解你在這裡談論的影響程度，無論是通貨膨脹還是對該業務的經濟敏感性。

My second question was just thinking about Rinvoq and Skyrizi formulary and pricing dynamics going forward as biosimilar Humira enters the market. I guess are you are expecting or are you hearing through discussions, any major shifts in the way payers are thinking about those products as we think about pricing coming down in obviously, the largest kind of product in the space there.

我的第二個問題只是考慮隨著生物仿製藥 Humira 進入市場，Rinvoq 和 Skyrizi 的處方和定價動態。我猜你是在期待還是通過討論聽到，當我們考慮到價格明顯下降時，付款人對這些產品的看法發生了任何重大轉變，這是該領域最大的產品。

This is Carrie. I'll take your first question around Juvederm and as Rick said, there was a onetime promotional event that we ran in the U.S. for Juvederm in Q2 of last year, and it was highly successful and it increased sales in the sales space, which created this challenging prior year comparison.

這是嘉莉。我會回答你關於 Juvederm 的第一個問題，正如 Rick 所說，去年第二季度我們在美國為 Juvederm 舉辦了一次促銷活動，它非常成功，它增加了銷售空間的銷售額，這創造了這個具有挑戰性的上一年比較。

So that was the key driver. But as you noted, there is also this impact, economic impact that is suggestive of some early changes in consumer behavior. And that really isn't surprising in light of the inflationary pressures that we're seeing on discretionary income. And as Rick said, the filler market is slightly more sensitive to that than toxins for a few reasons. We mentioned the price point.

所以這是關鍵的驅動力。但正如你所指出的，也存在這種影響，經濟影響暗示了消費者行為的一些早期變化。鑑於我們看到的可自由支配收入的通脹壓力，這真的不足為奇。正如 Rick 所說，由於幾個原因，填充劑市場對它的敏感性比毒素稍微高一些。我們提到了價格點。

So a price point of closer to $1,000 versus $500 for toxin. Also the nature of the filler business is different than toxin from a patient dynamic and treatment dynamic and that there is a longer interval between treatments for fillers versus toxins, which is sort of like a more regular treatment paradigm a few times a year.

因此，與毒素 500 美元相比，價格接近 1,000 美元。此外，填充劑業務的性質不同於患者動態和治療動態的毒素，填充劑治療與毒素治療之間的間隔更長，這有點像一年幾次更常規的治療範例。

Also, the patient bases are different. When you think about the toxin patient base and those have cosmetics, the majority of the patient base is continuing patients versus more of a reliance on new patient acquisition. And so those are some of the factors we're thinking about when we think about the deceleration of the filler market in Q2 but while the market has slowed and despite the performance in Q2, we do continue to expect a positive second half growth for U.S. Juvederm. Really waited more in the fourth quarter as we're going to launch 2 new fillers in the fourth quarter and those 2 new fillers will get us into incremental categories for HA fillers, including jawline and skin quality which will help to drive some incremental demand at the end of the year.

此外，患者基礎不同。當您考慮毒素患者群和那些有化妝品的患者時，大多數患者群是繼續患者，而不是更多地依賴新患者獲取。因此，當我們考慮第二季度填料市場的減速時，這些是我們正在考慮的一些因素，儘管市場已經放緩並且儘管第二季度表現良好，但我們確實繼續預計美國下半年將出現正增長。尤文登。第四季度真的等待了更多，因為我們將在第四季度推出 2 種新填充劑，這 2 種新填充劑將使我們進入 HA 填充劑的增量類別，包括下頜線和皮膚質量，這將有助於推動一些增量需求年底。

And in terms of your question around economic impact outside of the U.S., we are watching that very closely, and we really have not seen that yet outside of the U.S.

關於你關於美國以外的經濟影響的問題，我們正在密切關注這一點，我們真的還沒有在美國以外看到這一點。

In terms of your second question, again, it's Jeff. Thanks for that. We're -- we don't see some significant pressures on Skyrizi and Rinvoq. Now we always have a discussions with the payers, we look at our contracting strategy. But I think we fall back on our clinical evidence that we have on these 2 major assets.

關於你的第二個問題，還是傑夫。感謝那。我們 - 我們沒有看到 Skyrizi 和 Rinvoq 面臨一些重大壓力。現在我們總是和付款人討論，我們看看我們的承包策略。但我認為我們依賴於我們在這兩項主要資產上擁有的臨床證據。

I mean we have 4 head-to-head trials against other major competitors with Skyrizi, where we have just really gross superiority versus whether it's an IL-17, whether it's Humira, which one day will be biosimilar, STELARA, et cetera.

我的意思是，我們與 Skyrizi 進行了 4 次與其他主要競爭對手的正面交鋒試驗，與它是否是 IL-17、是否是 Humira、哪一天將是生物仿製藥、STELARA 等相比，我們確實具有明顯的優勢。

So just the pure performance there and the momentum, it's clearly a distinguished asset. We're going to be first in terms of Crohn's to start to establish that new area and build the market there. And I think on Rinvoq to some degree, there's only one other JAK inhibitor that is not going to have the scope of indications and it's Xeljanz. And Xeljanz has been significantly wounded based on the oral surveillance data.

因此，僅僅是那裡的純粹表現和勢頭，它顯然是一項傑出的資產。就克羅恩而言，我們將率先開始建立新領域並在那裡建立市場。而且我認為在某種程度上，在 Rinvoq 上，只有另一種 JAK 抑製劑不具有適應症範圍，它是 Xeljanz。根據口述監測數據，Xeljanz 已經受了重傷。

So in terms of our ability to build and protect and grow Skyrizi and Rinvoq into the next stage of development, we're quite confident that we have the assets to be able to do that.

因此，就我們建立、保護和發展 Skyrizi 和 Rinvoq 進入下一發展階段的能力而言，我們非常有信心擁有能夠做到這一點的資產。

Our next question is from Steve Scala, Cowen.

我們的下一個問題來自 Cowen 的 Steve Scala。

Two questions. First, Rick, in the past, you have laid out 4 factors that will dictate Humira's trajectory in 2023. The first 2 were Humira access and biosimilar price, and it's clear, it's too early for any news on either of those points.

兩個問題。首先，Rick，在過去，您已經列出了 4 個因素將決定 Humira 在 2023 年的發展軌跡。前兩個是 Humira 的准入和生物仿製藥價格，很明顯，關於這兩個方面的任何消息都為時過早。

But the second 2 were competitive in these biosimilars, which you said in part was interchangeability and also the biosimilar ability to supply the market. So those 2 factors, 3 and 4 are things that won't fluctuate and presumably, you have some visibility on that now.

但是後兩個在這些生物仿製藥中具有競爭力，您說的部分原因是可互換性以及供應市場的生物仿製藥能力。因此，這 2 個因素，3 和 4 是不會波動的，大概你現在對此有所了解。

So I'm just wondering if there's anything unusual occurring there. And in discussions, how important is interchangeability with payers. The second question is, and I apologize if I missed it, but are there any updates on the TNF steroid conjugate and is Phase II RA data still expected this year?

所以我只是想知道那裡是否發生了任何不尋常的事情。在討論中，與付款人的互換性是多麼重要。第二個問題是，如果我錯過了，我深表歉意，但是關於 TNF 類固醇偶聯物是否有任何更新，今年是否仍有望獲得 II 期 RA 數據？

All right. Thanks, Steve. This is Rick. I'll cover the first one. And Roopal can cover the second one. So you are correct. That is what I described a meeting or 2 ago as the 4 variables. I would say when you think about interchangeability, I think you have to think about it in the backdrop of not just interchangeability, but also what is the profile that is the closest to Humira today?

好的。謝謝，史蒂夫。這是瑞克。我將介紹第一個。而 Roopal 可以覆蓋第二個。所以你是對的。這就是我將一次或 2 年前的會議描述為 4 個變量。我想說當你想到互換性時，我認為你不僅要在互換性的背景下考慮它，還要考慮到今天最接近修美樂的輪廓是什麼？

And we can look at all the biosimilars and have -- we have pretty good visibility as to what that profile looks like. And what I would say is to get a profile that is interchangeable and is consistent with the current Humira that's predominantly in the marketplace today, that's probably going to occur in the summer of 2023.

我們可以查看所有的生物仿製藥，並且我們可以很好地了解該配置文件的外觀。我想說的是獲得一個可互換的配置文件，並且與目前主要在市場上的 Humira 一致，這可能會在 2023 年夏天發生。

There should be 1 or 2 biosimilars. They have a profile that looks like that. And that would make it somewhat easier for an organization to make a switch. So I think that will play an important variable.

應該有 1 或 2 種生物仿製藥。他們有一個看起來像這樣的個人資料。這將使組織更容易進行轉換。所以我認為這將起到一個重要的變數。

Nothing has changed in the last few months in what that profile looks like. And then obviously, supply is an important aspect that certainly, anyone that we're looking at making a significant change in their position with Humira is going to want to make sure that they're going with a company that has the ability to be able to produce volume at significant volumes, Humira, and they can do it sustainably.

在過去的幾個月裡，該配置文件的外觀沒有任何變化。然後很明顯，供應是一個重要方面，當然，我們正在考慮對其在 Humira 的立場做出重大改變的任何人都希望確保他們與一家有能力的公司合作大批量生產，修美樂，他們可以可持續地做到這一點。

So there are certain players that I would say clearly have that ability to be able to do it similar to us. Certainly, no one does it at the scale of us or anywhere close to the scale of us. But there are also a lot of small players that I think supply is going to be an important aspect and going to somewhat limit the ability to be able to have broad market impact.

所以有些球員我會說清楚地有能力像我們一樣做到這一點。當然，沒有人以我們的規模或接近我們規模的任何地方這樣做。但也有很多小企業，我認為供應將是一個重要方面，並且會在一定程度上限制能夠產生廣泛市場影響的能力。

And so those are going to be important dynamics as we negotiate with the various managed care organizations. I can tell you that we're talking through those kinds of things with them. Roopal?

因此，當我們與各種管理式醫療組織進行談判時，這些將成為重要的動力。我可以告訴你，我們正在和他們討論這些事情。羅帕爾？

Thanks. Yes. So 154 is our anti-TNF conjugated steroid, as you mentioned, and it's enabled to target delivery steroid directly to inflammatory cells. So we do have that Phase II running several hundred patients, and we still anticipate getting [the weed] later this year and then further data to follow next year.

謝謝。是的。所以 154 是我們的抗 TNF 結合類固醇，正如你所提到的，它能夠將類固醇直接靶向炎症細胞。所以我們確實有數百名患者的第二階段，我們仍然預計今年晚些時候會得到[雜草]，然後明年會有更多的數據。

Our next question is Chris Raymond, Piper Sandler.

我們的下一個問題是派珀桑德勒的克里斯雷蒙德。

Two questions. Maybe one that's more broad policy and then another one that's maybe a little bit more detailed. So maybe first for Rick. I know you guys keep pretty close tabs on health care policy. Just on the most recent Senate Democrat drug pricing language in the reconciliation bill.

兩個問題。也許一個更廣泛的政策，然後另一個可能更詳細一點。所以也許首先是 Rick。我知道你們密切關注醫療保健政策。就在和解法案中最新的參議院民主黨藥物定價語言。

The provisions on the face of it seemed pretty manageable in terms of direct impact from pricing controls, but there's been some concern around this being just the start of something larger in terms of price controls. Any thoughts from you guys on this would be appreciated.

就價格控制的直接影響而言，表面上的規定似乎很容易管理，但有人擔心這只是價格控制方面更大範圍的開始。你們對此的任何想法將不勝感激。

And then maybe a more detailed question on ABBV-951. I know you guys haven't provided specific guidance on this or On Duodopa, but there seems to be a lot of recognition of ABBV-951 among movement disorder KOLs as a real improvement in terms of overcoming reticence around Duodopa. Just how should we be thinking about ABBV-951 vis-a-vis Duodopa, if approved?

然後可能是關於 ABBV-951 的更詳細的問題。我知道你們還沒有提供關於這個或關於 Duodopa 的具體指導，但似乎有很多運動障礙 KOL 對 ABBV-951 的認可是在克服 Duodopa 沉默方面的真正改進。如果獲得批准，我們應該如何考慮 ABBV-951 與 Duodopa？

Okay. So I'll take the first question. I mean, I think if you look at the drug pricing proposal that's out there, it's certainly an important issue for us. And I think it's an important issue for patients. I think if I look at that bill, and I'm assuming that if there were something that were to pass, it would be somewhat consistent with what was in the build back better for the Senate Finance text.

好的。所以我會回答第一個問題。我的意思是，我認為如果您查看現有的藥品定價提案，這對我們來說肯定是一個重要問題。我認為這對患者來說是一個重要問題。我認為，如果我查看該法案，並且我假設如果有什麼要通過的話，它將與參議院財政文本中更好的構建內容保持一致。

And so far, it looks like that, but obviously evolving a bit here as we go along. And if I look at it in total, what I'd say is there's a couple of positive things in there. Certainly, most notably, the $2,000 cap out-of-pocket costs for patients and the ability to be able to smooth. I think that's an important step in increasing affordability, especially for patients in Medicare Part D and so that's something we've been supportive of. We've been vocal that we think that's an important step forward.

到目前為止，它看起來像這樣，但隨著我們的進行，這裡顯然會發生一些變化。如果我從整體上看，我想說的是那裡有一些積極的東西。當然，最值得注意的是，2,000 美元的患者自付費用上限和能夠順利進行的能力。我認為這是提高負擔能力的重要一步，特別是對於醫療保險 D 部分的患者，所以這是我們一直支持的事情。我們一直直言我們認為這是向前邁出的重要一步。

But I'd say on balance, this is a bill that has far more negatives that it has positive in it. And I think, frankly, although it may not be short term, that challenging from a financial standpoint, I think the long-term implications of this bill are pretty significant.

但總的來說，我想說的是，這項法案的負面因素遠多於正面因素。我認為，坦率地說，雖然這可能不是短期的，但從財務角度來看具有挑戰性，我認為該法案的長期影響非常重要。

And they really hinge around this so-called negotiation clause that's in there and how that's being implemented, particularly for small molecules. And if you're familiar with it, essentially what it says is that CMS or we're assuming it will be CMS has the ability at a certain point in time to be able to negotiate a price on a set of drugs.

他們真的圍繞著這個所謂的談判條款以及它是如何實施的，特別是對於小分子。如果您熟悉它，基本上它所說的是 CMS 或者我們假設 CMS 有能力在某個時間點就一組藥物協商價格。

And by the time you get there, it will be a big set of drugs that they'll have the ability to be able to negotiate on. And the key issue is this, essentially, they have full latitude to basically decide whatever price they want the drug to pay.

當你到達那裡時，他們將有能力談判一大堆藥物。關鍵問題是，基本上，他們有充分的自由來決定他們希望藥物支付的任何價格。

And I wouldn't necessarily call it a negotiation because the only alternative that the manufacturer has is to accept a 95% penalty on their revenues or, in essence, take a 95% discount. So it's not a negotiation. We should just call it what it is. It's price control is what they're basically putting in place if the language stays the same.

而且我不一定將其稱為談判，因為製造商唯一的選擇是接受對其收入的 95% 的罰款，或者實質上是 95% 的折扣。所以這不是談判。我們應該稱它為它是什麼。如果語言保持不變，他們基本上會實施價格控制。

And ultimately, I think the real challenge is how we invest in this as an industry in innovation. If you take small molecules as an example, I'll walk you through an example that illustrates the plan that I'm going to raise here. Take a small molecule, it says at year 9 after the first approval, CMS has the right to be able to negotiate the price on that drug.

最終，我認為真正的挑戰是我們如何將其作為一個創新行業進行投資。如果你以小分子為例，我將通過一個例子來說明我將在這裡提出的計劃。以一個小分子為例，它表示在第一次批准後的第 9 年，CMS 有權就該藥物的價格進行談判。

So if you take an oncology drug as an example, how do we develop oncology drugs in this industry? And what the regulatory authorities typically require us to do to be able to develop our oncology drug. Well, they typically require you to do and what we typically do is we go into patients who have failed on all the existing therapies, fourth-line patients, fifth-line patients. And we take whatever drug we have, and we determine do we have a positive benefit risk in that patient population.

那麼如果以腫瘤藥物為例，我們如何在這個行業開發腫瘤藥物呢？以及監管機構通常要求我們做什麼才能開發我們的腫瘤藥物。好吧，他們通常要求您做，而我們通常做的是我們進入所有現有療法均失敗的患者，四線患者，五線患者。我們服用我們擁有的任何藥物，並確定我們在該患者群體中是否具有積極的受益風險。

If we find that we do, then we seek approval for that drug in that patient population so that those patients will get the benefit of that drug. And then we start to work our way up towards front line, those who are refractory patients are typically very small populations of patients, right? And you can never get a return on a drug just on that patient population. And then you work your way up to front line. Or second line, wherever you end up, that process typically takes 7 to 9 years because of the length of the trials. So essentially, with this, by the time you got to the larger populations, you'd be within a year or 2 of when CMS could change the price.

如果我們發現我們這樣做了，那麼我們會在該患者群體中尋求對該藥物的批准，以便這些患者將從該藥物中受益。然後我們開始向一線前進，那些難治性患者通常是非常小的患者群體，對吧？而且，您永遠無法僅針對該患者群體獲得藥物回報。然後你就一路上前線。或者第二線，無論你最終到達哪裡，由於試驗的長度，這個過程通常需要 7 到 9 年。所以基本上，有了這個，當你接觸到更多的人群時，你會在一兩年內 CMS 可以改變價格。

But one, it's impossible to figure out what the return is going to be, so how do you invest. Two, it really puts negative pressure on you not to continue to develop new indications. But the most detrimental part of it is to patients who need these drugs or small indications or in later stage.

但是第一，不可能弄清楚回報是多少，那麼你如何投資。第二，它確實給你帶來了負面壓力，不要繼續開發新的適應症。但其中最不利的部分是對需要這些藥物或小適應症或後期的患者。

Because you're faced with the dilemma, and this is a horrible dilemma, right, as a company and for patients. You're faced with a dilemma of do I choose not to seek approval in those late-stage patients, so I don't start the clock and wait until I'm closer to frontline before I start the clock. That is not the right policy.

因為你面臨著兩難境地，這是一個可怕的兩難境地，對，作為一家公司和患者。你面臨著我是否選擇不為那些晚期患者尋求批准的兩難選擇，所以我不開始計時，等到離一線更近了才開始計時。這不是正確的政策。

And I would say on balance, this bill will have a couple of things that are good for patients that I'm fully supportive of. But unless Congress wants to harm patients and harm innovation in this industry, they need to change that part of it. It doesn't make sense. It's shortsighted.

總的來說，我想說的是，這項法案將有幾件事對我完全支持的患者有好處。但除非國會想要傷害患者並傷害該行業的創新，否則他們需要改變這部分內容。這沒有意義。這是短視的。

Now they can change it in a couple of different ways. They can determine, okay, what is a floor price or a maximum discount by year and then you can calculate the return on investment that you're going to have on the drug or they can at least make it consistent with biologics that are out of 13 years.

現在他們可以用幾種不同的方式改變它。他們可以確定，好的，每年的底價或最大折扣是多少，然後你可以計算你將在藥物上獲得的投資回報，或者他們至少可以使其與生物製劑相一致。 13年。

Otherwise, the investment in small molecule oncology drugs or neuroscience drugs, which Medicare patient populations are highly dependent on new innovative drugs in those areas because their elderly patients are going to suffer.

否則，對小分子腫瘤藥物或神經科學藥物的投資，醫療保險患者群體高度依賴這些領域的新創新藥物，因為他們的老年患者將受到影響。

And the [CBO] report that was published back in April of last year, clearly pointed that out. So this isn't something I'm just saying or industry is just saying. And in fact, if anything, I'd say they probably undercall the magnitude of the impact.

去年 4 月發布的 [CBO] 報告明確指出了這一點。所以這不是我只是在說什麼，或者行業只是在說。事實上，如果有的話，我想說他們可能低估了影響的嚴重性。

So this is an important issue. We all know the affordability and access for Medicare patients is important. But you don't need to destroy the innovation model in the process. in order to provide that. And so I'm hopeful that we'll see some movement here and some rationality will play out.

所以這是一個重要的問題。我們都知道醫療保險患者的負擔能力和獲取途徑很重要。但是你不需要在這個過程中破壞創新模式。為了提供這一點。所以我希望我們能在這裡看到一些動靜，一些理性會發揮出來。

Okay. And to address your ABBV-951, it's Jeff. Thanks for the question. So I think some perspective is globally, Duodopa is about $0.5 billion brand. And certainly, we've said that we believe that ABBV-951 could certainly double that up or more I'll give you the perspective of why we think that way.

好的。為了解決您的 ABBV-951，我是 Jeff。謝謝你的問題。所以我認為從全球來看，多多巴是一個價值 5 億美元的品牌。當然，我們已經說過，我們相信 ABBV-951 肯定可以翻倍或更多。我會告訴你為什麼我們會這樣想。

So if you look at the advanced Parkinson's patients, about 85% sort of cycle when they stay on these generic orals that become less and less and less effective. And the only thing they can really do, and that's about 15% of the market, the advanced Parkinson market, is they can move to either deep brain stimulation or Duodopa, but you got to go through a surgical barrier. So the families and the patients are forced to think if I need to get improvement in my symptoms and my quality of life, I'm forced to basically think about do I get a hole in my head or a hole in my stomach with a gastric surgery. This is going to be a subcu. And so we see in our market research that at least 40% to 60% of people never want to move towards DBS or Duodopa.

因此，如果您查看晚期帕金森病患者，大約 85% 的循環是當他們繼續使用這些變得越來越無效的通用口服藥物時。他們唯一真正能做的，大約 15% 的市場，先進的帕金森市場，是他們可以轉移到深部腦刺激或 Duodopa，但你必須通過手術障礙。所以家屬和病人不得不考慮我是否需要改善我的症狀和生活質量，我不得不基本上考慮是我的頭上有個洞還是胃裡有個洞？手術。這將是一個子庫。因此，我們在市場研究中看到，至少有 40% 到 60% 的人不想轉向星展銀行或多多巴。

So we think this is a way where we can start to expand and create a new market segment, in essence, a subcutaneous segment where you don't have to take that risk on the surgery. And like you mentioned in the movement disorder centers, there's a significant amount of experts that are excited about this new option, and we believe that it's going to be a real innovation for patients without having the surgery.

因此，我們認為這是我們可以開始擴展和創建新細分市場的一種方式，本質上是一個無需承擔手術風險的皮下細分市場。就像你在運動障礙中心提到的那樣，有大量專家對這個新選擇感到興奮，我們相信這對於沒有手術的患者來說將是一項真正的創新。

And Chris, this is Rob. As Jeff said, I mean, we expect this to be market expanding. At the JPMorgan conference earlier this year, we did give peak revenue guidance from ABBV-951 greater than $1 billion. Obviously, Duodopa is $0.5 billion now. If you're modeling it, obviously, there'll be some level of [canalization] I'd say, minor level of canalization on Duodopa. But when you think about the combination between ABBV-951 and Duodopa, obviously, it's going to grow the revenue for the company and expand the market.

克里斯，這是羅伯。正如傑夫所說，我的意思是，我們預計這將擴大市場。在今年早些時候的摩根大通會議上，我們確實給出了 ABBV-951 超過 10 億美元的最高收入指導。顯然，多多巴現在是 5 億美元。如果你在建模，很明顯，我會說會有一定程度的[管道化]，在 Duodopa 上會有輕微的管道化。但是，當您考慮 ABBV-951 和 Duodopa 的結合時，顯然，它將增加公司的收入並擴大市場。

It's Tim Anderson with Wolfe Research.

是沃爾夫研究公司的蒂姆·安德森。

If I could just go back to the whole 23 versus 24 thing. I thought that in the past, you guys have said earnings would trough in 2023 and then return to growth in 2024. Is that still the case? Or is that off the table?

如果我可以回到整個 23 對 24 的事情。我以為過去你們說收益會在2023年觸底，然後在2024年恢復增長，現在還是這樣嗎？或者這不在桌面上？

And then second question goes back to the ABBY-154 compound your antibody drug conjugate. We understand that the timing is still on track, but I just it feels like to me there's a distinct lack of enthusiasm towards this program, you don't seem to mention that much or at all really, despite its novelty. And despite it being in your most critical franchise of immunology. So has the enthusiasm waned over, let's say, the last couple of years?

然後第二個問題回到您的抗體藥物偶聯物的 ABBY-154 化合物。我們知道時間安排仍在軌道上，但我只是覺得我對這個項目明顯缺乏熱情，儘管它很新穎，但你似乎沒有提及太多或根本沒有提及。儘管它是您最關鍵的免疫學專營權。那麼，比方說，在過去的幾年裡，熱情是否已經減弱？

So Tim, this is Rob. On your first question, what we've said -- we've talked about this 45% with a range around that plus or minus 10%. And using, obviously, the Europe analog as an example. And in that case, with the steep erosion year 1 and '23, you would expect then the trough to be in '23 and return to growth in '24. As this plays out, we'll see how that shakes out.

所以蒂姆，這是羅伯。關於你的第一個問題，我們所說的——我們已經談到了這 45%，其範圍在正負 10% 左右。顯然，以歐洲模擬為例。在這種情況下，隨著第 1 年和 23 年的急劇侵蝕，您會預計到 23 年將出現低谷並在 24 年恢復增長。隨著這種情況的發生，我們將看到它是如何發生的。

Ultimately, if more of it happens in '24, you obviously have another year of growth for all your growth brands. And so you have a different floor in that scenario. But most importantly, it's what happens in '25 and beyond.

最終，如果更多的情況發生在 24 年，那麼您的所有增長品牌顯然還有一年的增長。所以在那種情況下你有不同的樓層。但最重要的是，這是 25 年及以後發生的事情。

When you look at this company with the growth drivers we have, we'll be delivering high single-digit growth in '25 and beyond, which is industry-leading. We'll have the lowest LOE exposure in the industry in the second half of this decade. And so we're focused on the long term, and we feel very good about the prospects of this business.

當您以我們擁有的增長動力來看待這家公司時，我們將在 25 年及以後實現高個位數增長，這是行業領先的。在本世紀後半葉，我們將擁有業內最低的 LOE 風險敞口。所以我們專注於長期，我們對這項業務的前景感覺非常好。

But as it stands now, the most recent direction we've given is expect that first year erosion, so that 45% plus or minus 10%, which then play out to return to growth in '24. We'll obviously update the market as we see it play out next year.

但就目前而言，我們給出的最新方向是預計第一年的侵蝕，即 45% 正負 10%，然後在 24 年恢復增長。我們顯然會更新市場，因為我們看到它在明年發揮作用。

Maybe I'll take this one. This is Tom Hudson. I'm a clinical immunologist, and I know how we've been using steroids, they can give very profound and deep immunosuppression, decrease inflammation, and that's often used in severe cases when patient shows up.

也許我會拿這個。這是湯姆哈德森。我是一名臨床免疫學家，我知道我們是如何使用類固醇的，它們可以提供非常深刻和深度的免疫抑制，減少炎症，這通常在患者出現的嚴重病例中使用。

So we know that the response is very strong, but there are a lot of side effects. And wherein our problem is always weaning the steroids out in the clinic. So here, again, the combination of immunomodulator like TNF and steroid have that potential of giving us that deep, deep response very quickly to remove the immunosuppression.

所以我們知道反應很強烈，但是副作用也很多。其中我們的問題總是在診所中停止使用類固醇。所以在這裡，再一次，像 TNF 和類固醇這樣的免疫調節劑的組合有可能讓我們非常迅速地做出深刻的反應，以消除免疫抑制。

And based on the data we've seen preclinically in our Phase I studies, we're not seeing those biomarkers or side effects in the bone of brain, or cortisol or others. So we've already demonstrated that, and we had nice data -- the other -- so that's my enthusiasm. We expect to see deep responses, durable responses with much well better tolerated than steroids.

根據我們在 I 期研究中看到的臨床前數據，我們沒有在大腦骨骼、皮質醇或其他物質中看到這些生物標誌物或副作用。所以我們已經證明了這一點，我們有很好的數據——另一個——所以這就是我的熱情。我們希望看到深度反應、持久反應，其耐受性比類固醇好得多。

Our program, and we've shown this also is that we've actually believed in the platform and we're developing steroid ADCs for other targets to target other immune systems -- other immune cells, more specifically around some T cells or some B cells or some fibroblasts. These programs are coming forward. We think this is a profound platform in immunology to go after different biologies in a very targeted steroid suppression of different specific immune cell types, and that's going to play out over the next couple of years.

我們的計劃，我們也證明了這一點，我們實際上相信該平台，我們正在開髮用於其他目標的類固醇 ADC，以針對其他免疫系統——其他免疫細胞，更具體地說是圍繞一些 T 細胞或一些 B細胞或一些成纖維細胞。這些計劃正在向前推進。我們認為這是免疫學領域的一個重要平台，可以通過非常有針對性的類固醇抑制不同的特定免疫細胞類型來追求不同的生物學，這將在未來幾年內發揮作用。

So based on the data we saw, we expanded the platform to other biomarkers getting into other specific immune cell types. Of course, we're quiet because we need to see the data, all the study has been fully recruited, actually moved faster than we expected. And the day was randomized. We're just going to see the data in the fall because it's a blinded study. But the enthusiasm is there.

因此，根據我們看到的數據，我們將平台擴展到其他生物標誌物進入其他特定免疫細胞類型。當然，我們之所以安靜，是因為我們需要看數據，所有的研究都已經全部招募完畢，實際上移動的速度比我們預期的要快。這一天是隨機的。我們將在秋季看到數據，因為這是一項盲研究。但是熱情是有的。

And we also, of course, seeing that data, and then we have PMR because we also started studies there and Crohn's disease. We'll see that data later, but the more data we have, the more likely we're going to expand this program to other indications where we believe that deep steroid suppression with TNF might actually bring new solutions for patients.

當然，我們也看到了這些數據，然後我們有了 PMR，因為我們也在那裡開始研究克羅恩病。我們稍後會看到這些數據，但我們擁有的數據越多，我們就越有可能將該計劃擴展到其他適應症，我們認為用 TNF 進行深度類固醇抑制實際上可能為患者帶來新的解決方案。

Our next question is Geoff Meachem, Bank of America.

我們的下一個問題是美國銀行的 Geoff Meachem。

Thank you so much for the question. Not to belabor the point on Humira but I wanted to ask you is the long-term meeting the 4-year kind of trends that we saw this quarter for Humira in Europe. Is that still a good proxy or how you guys are thinking about the tail for Humira, just given we're coming up on 4 years in Europe and we're talking about high single-digit erosion still.

非常感謝你的問題。不是在 Humira 上強調這一點，但我想問你是長期滿足我們本季度在歐洲看到的 Humira 的 4 年趨勢。這仍然是一個很好的代理嗎，或者你們如何考慮修美樂的尾巴，因為我們在歐洲即將迎來 4 年，而且我們仍在談論高個位數的侵蝕。

So I wanted to kind of ask you about the tail piece of what you expect in the U.S. And the second question, just on Rinvoq, I wanted to ask you also on the -- since the FDA labeling change, you just see any changes with regard to persistent rates or new starts just on your feedback from the field and how docs view the safety of the JAK class.

所以我想問你關於你對美國的期望的最後部分。第二個問題，就在 Rinvoq 上，我還想問你——因為 FDA 的標籤發生了變化，你會看到任何變化關於持續費率或新開始僅取決於您從該領域的反饋以及文檔如何看待 JAK 類的安全性。

Jeff, this is Rob. I'll take your first question. And the way we've talked about Humira erosion where it's played out in Europe as we saw that steep erosion in year one, more moderate erosion years beyond. In our modeling now, that's probably the best way to think about it is deep erosion year 1, more moderate. You'll have an annualization impact in year 2, but more moderate beyond that.

傑夫，這是羅伯。我會回答你的第一個問題。以及我們談到修美樂侵蝕的方式，它在歐洲上演，因為我們在第一年看到了陡峭的侵蝕，幾年後的侵蝕更加溫和。在我們現在的建模中，這可能是考慮它的最佳方式是深度侵蝕第 1 年，更溫和。您將在第 2 年產生年化影響，但除此之外更為溫和。

And specifically within the [wave 1] countries, when we look at Europe, and the level of revenue we have this year relative to pre-LOE we still have about 30% of the revenue footprint. So it gives you a sense of where Europe is after 4 years. Obviously, as we model the U.S. out, and it will be more specific in the future, but right now, we're using Europe as an analog.

特別是在 [wave 1] 國家，當我們看歐洲時，我們今年的收入水平相對於 LOE 之前的收入，我們仍然擁有大約 30% 的收入足跡。因此，它讓您了解 4 年後歐洲的位置。顯然，當我們模擬美國時，它會在未來更加具體，但現在，我們正在使用歐洲作為模擬。

And regarding Rinvoq in terms of perceptions from the field or what we're seeing. It's largely developing as we predicted. So we do see segments of physicians that are more wary of the JAKs after the label change. However, we anticipated that.

關於 Rinvoq 從現場的看法或我們所看到的方面。正如我們預測的那樣，它在很大程度上正在發展。因此，我們確實看到部分醫生在標籤更改後對 JAK 更加警惕。然而，我們預料到了這一點。

So we are starting to see a recovery in second line plus in RA as we anticipated. And the new indications because really we'll be the only JAK inhibitor with the 4 big indications of RA, PSA, AS and then non-radiographic ultimately in the fall. That just builds upon the confidence level of the physician. So that's what we're feeling from the field. I'll mention maybe some color on ulcerative colitis. I mentioned that we're encouraged on the ulcerative colitis start. So we saw in the quarter because we launched in early April. We saw 600 unique gastroenterologists start to write prescriptions, which is quite interesting and good, it is positive. And about half of those customers had never written a JAK inhibitor. So Xeljanz was approved.

因此，正如我們預期的那樣，我們開始看到二線和 RA 的複蘇。以及新的適應症，因為我們將成為唯一具有 RA、PSA、AS 和非放射學四大適應症的 JAK 抑製劑，最終在秋季。這只是建立在醫生的信心水平之上。這就是我們在現場的感受。我會提到潰瘍性結腸炎的一些顏色。我提到我們鼓勵潰瘍性結腸炎開始。所以我們在本季度看到了，因為我們在 4 月初推出。我們看到600個獨特的腸胃科醫生開始寫藥方，這很有趣，很好，很積極。大約一半的客戶從未編寫過 JAK 抑製劑。所以 Xeljanz 被批准了。

And so we're seeing, obviously, the ability of these customers to understand the overall risk benefit of Rinvoq relative to, let's say, another JAK inhibitor. So I feel that our communication is on track, and we're seeing positive feedback as we build the indications that we've highlighted in the call.

因此，我們顯然看到了這些客戶了解 Rinvoq 相對於另一種 JAK 抑製劑的整體風險收益的能力。因此，我覺得我們的溝通正在走上正軌，並且在我們建立我們在電話中強調的跡象時，我們看到了積極的反饋。

Our next question is (inaudible) with UBS.

我們的下一個問題是（聽不清）瑞銀。

Another one on the '23 Humira guidance. Could you just walk us through -- at the point at the end of 3Q, what percentage of contracts or volume will you have confirmed at that point? And then it sounds like that by the -- by the time you have the full year results, you're still anticipating that there could be a meaningful change.

'23 Humira 指南中的另一個。您能否簡單介紹一下——在第三季度末，您將在那個時候確認多少百分比的合同或交易量？然後聽起來像 - 當你有全年的結果時，你仍然預計可能會有有意義的變化。

Could you just confirm that's a fair characterization. And then just on AbbVie-154. What are you hoping to see with the Phase II data that we're going to get at year end? And what's the threshold here you need to surpass to move forward?

你能否確認這是一個公平的描述。然後就在 AbbVie-154 上。您希望通過我們將在年底獲得的第二階段數據看到什麼？你需要超越什麼門檻才能繼續前進？

Yes. So if we look at the discussions that we've highlighted and Rick highlighted, I think and they're progressing as we would expect. So typically, they start in the late spring. And look, these are complex negotiations. They go on for many, many months.

是的。因此，如果我們看看我們強調的和 Rick 強調的討論，我認為他們正在按照我們的預期進行。因此，它們通常在晚春開始。看，這些都是複雜的談判。他們持續了很多很多個月。

In many years, we would have completed the -- at least the large PBM negotiations, which is the vast majority of the volume by that October time frame. In some cases, as you probably know, the payers would publish this information. But very often, not always, the immunology and inflammatory segment, those negotiations can go on longer, and they're very often published as a TBD in what used to be called the exclusionary formulary.

多年後，我們將完成 - 至少是大型 PBM 談判，這是 10 月份時間框架內的絕大多數。在某些情況下，您可能知道，付款人會發布此信息。但很多時候，並非總是如此，在免疫學和炎症部分，這些談判可以持續更長時間，並且它們經常作為 TBD 發佈在過去被稱為排他性處方集的地方。

So we would -- as Rick mentioned, we would have visibility to sort of the status on the volume in that October timeframe. That's a reasonable assumption. Again, I don't know for sure, given the complexity of biosimilar negotiation, which has never taken place before.

所以我們會 - 正如 Rick 提到的那樣，我們可以在 10 月份的時間範圍內對交易量的狀態進行排序。這是一個合理的假設。同樣，鑑於生物仿製藥談判的複雜性，我不確定，這是以前從未發生過的。

But that's a reasonable way to think about when we'd start to have the visibility to the volume component, as Rick highlighted.

但正如 Rick 強調的那樣，這是一種合理的方式來考慮我們何時開始看到體積組件。

And it's Roopal on the ABBY-154 question. Dovetailing on what Tom just walked through, things that we want to see are consistent with how we develop in immunology, certainly raising standard of care. So the way this was designed was to have that anti-TNF and then that direct delivery to avoid systemic side effects of the steroids. So you'd see sort of that one-two punch as Tom was describing and see that depth of response.

這是關於 ABBY-154 問題的 Roopal。與湯姆剛剛經歷的事情相吻合，我們希望看到的事情與我們在免疫學方面的發展方式一致，當然也提高了護理標準。因此，設計的方式是使用抗 TNF，然後直接給藥，以避免類固醇的全身副作用。所以你會看到湯姆描述的那種一兩拳，並看到反應的深度。

So once we see that type of information along with how it looks from a steroid standpoint, metabolic effects, bone effects taken together will give us a great sense of where it could fit before anti-TNFs even after we're studying patients that have failed anti-TNFs in this Phase II study.

因此，一旦我們看到這種類型的信息以及從類固醇的角度來看它的外觀、代謝效應、骨骼效應，我們就會很好地了解它在抗 TNF 之前的適用範圍，即使在我們研究失敗的患者之後也是如此本 II 期研究中的抗腫瘤壞死因子。

So taken together, that will give us a really good sense of where to go. And then remember, we're also going to get data on polymyalgia rheumatica. It's not an uncommon disease, and these patients are -- many of them are steroid-dependent, 50% or so 3 years and going and they can't withdraw from steroids and maybe 1/3, can be 5 plus 6 years.

綜上所述，這將使我們對要去哪裡有一個很好的了解。然後請記住，我們還將獲得有關風濕性多肌痛的數據。這不是一種罕見的疾病，這些患者是——他們中的許多人依賴類固醇，50% 左右 3 年左右，他們不能退出類固醇，也許 1/3，可能是 5 加 6 年。

They're stuck on steroids. So we'll see that data where we're able to prevent them from flaring and to be able to reduce their systemic steroid dose. So there's multiple facets to this and potentially a number of opportunities and then later on in Crohn's disease as well.

他們被類固醇困住了。因此，我們將看到能夠防止它們燃燒並能夠減少其全身性類固醇劑量的數據。因此，這涉及多個方面，並可能帶來許多機會，然後在克羅恩病中也是如此。

Thanks, Colin.

謝謝，科林。

Our next question is from Chris Shibutani with Goldman Sachs.

我們的下一個問題來自高盛的 Chris Shibutani。

Two questions, if I could. For Skyrizi, if I could just return to this question is how you're thinking about the long-term guidance. I think Skyrizi recalling that you said $7.5 billion, consisting of about $6 billion from the psoriatic complex. And yet you're almost already approaching something close to $5 billion. So can you tell us how you're thinking about how that could factor in any long-term thinking? And then for epcoritamab, positioning of that treatment in the overall treatment paradigm. How are you thinking about that in relation to, for instance, CAR-T therapy treatment options before, after.

兩個問題，如果可以的話。對於 Skyrizi，如果我可以回到這個問題，那就是您如何考慮長期指導。我想 Skyrizi 記得你說過 75 億美元，其中約 60 億美元來自銀屑病綜合症。然而，您幾乎已經接近 50 億美元。那麼你能告訴我們你是如何考慮這會如何影響任何長期思考的嗎？然後對於 epcoritamab，將該治療定位在整體治療範式中。您如何看待與之前和之後的 CAR-T 治療方案相關的問題。

So Chris, this is Rob. I'll take that question. So look, we're very encouraged by Skyrizi's continued strong performance. We remain confident in our ability to achieve or exceed that 2025 guidance. Now keep in mind, I mean, -- the Street also reflects that too, the Street is about $400 million higher than that $7.5 billion.

克里斯，這是羅伯。我會回答這個問題。所以看，我們對 Skyrizi 持續強勁的表現感到非常鼓舞。我們對實現或超過 2025 年指導方針的能力仍然充滿信心。現在請記住，我的意思是，華爾街也反映了這一點，華爾街比那 75 億美元高出約 4 億美元。

That said, we don't intend on frequently updating that guidance. Obviously, we'll provide that guidance update every 2 years or if there's an event or there's a major disconnect. So obviously, if the Street was way off, we want to point that out.

也就是說，我們不打算經常更新該指南。顯然，我們將每 2 年提供一次指導更新，或者如果發生事件或存在重大脫節。很明顯，如果這條街很遙遠，我們想指出這一點。

But overall, we're very encouraged about the uptake for Skyrizi. It's clearly demonstrating its ability to drive long-term growth for AbbVie, and we'll provide an update to long-term guidance at the appropriate time.

但總的來說，我們對 Skyrizi 的採用感到非常鼓舞。它清楚地展示了其推動 AbbVie 長期增長的能力，我們將在適當的時候提供長期指導的更新。

Thanks. And on the epcoritamab question. So I'm not going to go through all of the data points and we've described them several times in the public domain. What I would remind you of is that we've observed extremely robust efficacy in a heavily pretreated population.

謝謝。關於 epcoritamab 問題。所以我不會遍歷所有數據點，我們已經在公共領域多次描述過它們。我要提醒您的是，我們在經過大量預處理的人群中觀察到了極其強大的功效。

Now it's true to say that 40% of those patients have [failed] CAR-Ts, but 60% of those patients didn't [fail] CAR-T. Therefore, our expectation, our intention, rather, and as we've mentioned earlier on in Tom's prepared remarks, we are anticipating filing for accelerated approval during the second half year.

現在可以說，這些患者中有 40% 的 CAR-T [失敗]，但其中 60% 的患者沒有 [失敗] CAR-T。因此，我們的期望，我們的意圖，正如我們之前在湯姆準備好的評論中提到的那樣，我們預計在下半年提交加速批准。

And I think that what you can expect is that we believe that the total population, the total relapsed/refractory population, whether or not they fail CAR-Ts should have access to epcoritamab because of the strength of the data overall.

而且我認為你可以期待的是，我們相信總人口，總復發/難治人口，無論他們是否失敗 CAR-T，都應該能夠使用 epcoritamab，因為整體數據的強度。

In terms of future positioning, we've also discussed in the past our intention of initiating multiple phase -- additional Phase III, the confirmatory study for the DLBCL application what would be the confirmatory study, the Phase III study is ongoing. That's in the relapsed/refractory setting. And our anticipation is that we will initiate multiple additional Phase III, both in DLBCL and other indications over the coming 12 to 18 months.

在未來的定位方面，我們過去也討論過我們啟動多個階段的意圖——額外的 III 期，DLBCL 應用的確認性研究什麼是確認性研究，III 期研究正在進行中。那是在復發/難治性設置中。我們的預期是，我們將在未來 12 至 18 個月內啟動多個額外的 III 期臨床試驗，包括 DLBCL 和其他適應症。

Maybe I could just build on that, Chris, it's Jeff. So we've started to talk to different types of physicians, whether they're in the CAR-T centers or certainly the community centers. We're increasingly believing that this lymphoma is treated in the community centers. And so what we hear, at least at a high level from our research so far is wow, that efficacy is incredibly impressive, even after CAR T.

也許我可以在此基礎上再接再厲，克里斯，傑夫。因此，我們開始與不同類型的醫生交談，無論他們是在 CAR-T 中心還是社區中心。我們越來越相信這種淋巴瘤在社區中心得到治療。所以我們聽到的，至少在我們迄今為止的研究中的高水平是哇，這種功效令人難以置信的令人印象深刻，即使在 CAR T 之後也是如此。

But where they go is this simple subcu of epcoritamab may be the fastest way to deliver T cells to my patients I'm dealing with. So to build on Neil's point, that data doesn't look like it's niching the drug. In fact, it looks like it's sort of contributing to the idea of like this is a democratized type of medication for the lymphoma. So it's very encouraging from our initial work that we're doing with physicians.

但是他們去的地方是這種簡單的 epcoritamab 子庫可能是將 T 細胞輸送給我正在處理的患者的最快方法。因此，以尼爾的觀點為基礎，這些數據看起來不像是在利用藥物。事實上，它似乎在某種程度上促成了這樣一種想法，即這是一種用於治療淋巴瘤的民主化藥物。因此，從我們與醫生一起做的初步工作來看，這是非常令人鼓舞的。

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

謝謝，克里斯。接線員，我們有時間回答最後一個問題。

And that question comes from David Risinger with SBB Securities.

這個問題來自 SBB 證券公司的 David Risinger。

Yes. Thanks very much, and thanks for all the details on today's call. Rick, I was hoping that you could help us to understand the current M&A landscape, how would you characterize it broadly? And then if you could also comment more specifically on AbbVie with respect to the transaction opportunity set for AbbVie.

是的。非常感謝，感謝今天電話會議的所有細節。 Rick，我希望你能幫助我們了解當前的併購形勢，你會如何概括地描述它？然後，如果您還可以就為 AbbVie 設置的交易機會更具體地評論 AbbVie。

I think if you look at the M&A environment, I think many players are trying to add to their portfolios. I think there's less of an appetite for larger transactions right now in general across the industry.

我認為，如果你看看併購環境，我認為許多參與者都在嘗試增加他們的投資組合。我認為現在整個行業對大宗交易的興趣不大。

Some of that's probably predicated on the fact that the FTC has been pretty tough in their language around larger kinds of transactions and your ability to be able to get those through. And I think as it relates to us, I mean, we have continued to execute the strategy that we put in place after the Allergan transaction.

其中一些可能是基於這樣一個事實，即 FTC 對大型交易的語言非常強硬，並且您有能力通過這些交易。我認為這與我們有關，我的意思是，我們繼續執行我們在艾爾建交易後實施的戰略。

Allergan, obviously brought us a tremendous amount of diversity. That transaction has been highly successful and has really changed the look and the shape of AbbVie and it has clearly enhanced our performance, and we've done quite well.

艾爾建顯然給我們帶來了巨大的多樣性。這筆交易非常成功，確實改變了 AbbVie 的外觀和形狀，它明顯提高了我們的業績，我們做得很好。

Our focus is continuing to look for opportunities to be able to fill out our portfolio in areas that we believe there are opportunities to bring in strategic assets. We're probably working more on earlier-stage assets add to our R&D pipeline. Epcoritamab is a good example of the kinds of things that we're out looking for and finding to supplement the overall pipeline and I think that strategy has worked well, and it's a strategy that we'll continue to do going forward. Thank you.

我們的重點是繼續尋找能夠在我們認為有機會引入戰略資產的領域填補我們的投資組合的機會。我們可能正在更多地研究添加到我們研發管道中的早期資產。 Epcoritamab 是一個很好的例子，說明我們正在尋找和尋找補充整個管道的東西，我認為該策略運作良好，這是我們將繼續推進的策略。謝謝你。

Thanks, David. 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，大衛。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。

And thank you. This does conclude the call. You may disconnect your lines, and thank you for your participation.

謝謝你。這確實結束了通話。您可以斷開您的線路，並感謝您的參與。