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.

早安，感謝您的支持。歡迎參加 AbbVie 2022 年第二季財報電話會議。 （操作員指示）現在，我想介紹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.

早安，感謝您加入我們。今天與我一起參加電話會議的還有董事會主席兼首席執行官 Rick Gonzalez；羅布·邁克爾（Rob Michael），副董事長兼總裁；傑夫·斯圖爾特 (Jeff Stewart)，執行副總裁、首席商務官；以及研發高級副總裁兼首席科學官湯姆·哈德森（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.

參加電話會議問答環節的有外部事務副主席、首席法律官兼公司秘書 Laura Schumacher；艾爾建美學業務高級副總裁兼全球總裁 Carrie Strom；斯科特·布倫 (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，我要指出的是，我們今天所作的一些聲明可能被視為符合 1995 年《私人證券訴訟改革法案》的前瞻性聲明。

AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Additional information about these risks and uncertainties is included in our SEC filings.

AbbVie 警告稱，這些前瞻性陳述受風險和不確定性的影響，可能導致實際結果與前瞻性陳述中所示的結果有重大差異。有關這些風險和不確定性的更多資訊包含在我們的美國證券交易委員會 (SEC) 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聲明的義務。在今天的電話會議上，將採用非公認會計準則財務指標來幫助投資者了解 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.

這些非公認會計準則財務指標與我們今天的收益報告和監管文件中的可比公認會計準則財務指標進行了協調，可在我們的網站上找到。在我們發表準備好的發言之後，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，莉茲。大家早安，感謝大家今天的參與。我將簡要評論我們的整體表現，然後傑夫、湯姆和羅布將更詳細地回顧我們第二季度的業務亮點、渠道進展和財務業績。

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.

AbbVie 又一個季度表現強勁，調整後每股收益為 3.37 美元，超出我們的預期。總淨收入約為 146 億美元，以營運基礎計算成長 6.1%，符合我們的預期。這項業績反映了免疫學領域強勁的兩位數營運銷售成長，而 Skyrizi 在牛皮癬和 PSA 領域都取得了令人矚目的市佔率成長，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 最近在美國獲得批准用於治療克羅恩病，這將為其帶來另一個長期增長來源。由於今年上半年的強勁表現，我們上調了 Skyrizi 的全年業績預期。 RINVOQ 也表現出強勁的成長動能。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、異位性皮膚炎和潰瘍性結腸炎，這些適應症共同代表著重要的長期成長機會。

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、（聽不清楚）、QULIPTA 均實現了兩位數的連續銷售成長。治療重度憂鬱症的 Vraylar、治療慢性偏頭痛的 QULIPTA 和治療晚期帕金森氏症的 ABBV-951 均有待監管部門批准，這為我們的神經科學產品組合帶來了額外的近期成長機會。

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.

現在來談談美學。 Botox Cosmetic 再次表現出色，營業銷售額成長超過 20%。儘管通膨率居高不下，但美國毒素需求依然強勁，成長率高達十幾倍。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，我們去年舉辦的促銷活動與前一年相比很困難。由於經濟壓力，本季我們也看到一定程度的影響。我們繼續預期 Juvederm 將全年實現正成長，這得益於中國新冠疫情影響的減弱和美國推出 2 種新的填充劑，這將有利於下半年的成長。

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.

在血液腫瘤學領域，Imbruvica 繼續受到 CLL 新患者開始治療的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，我們將調整全年業績預期以反映這些影響。 Venclexta 在 CLL 和 AML 領域持續展現強勁的份額表現，營運銷售額實現了兩位數成長。 Venclexta 也正在針對其他具有吸引力的適應症進行註冊研究，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，旨在解決血癌和實體腫瘤領域尚未滿足的關鍵需求，並有望支持 AbbVie 在腫瘤學領域的下一波成長。總而言之，儘管我們在 CLL 市場面臨挑戰且 Imbruvica 競爭日益激烈，但我們投資組合的多樣性再次使我們能夠取得強勁的業績。

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 表現非常出色，今年的總銷售額預計將達到約 75 億美元。神經科學領域呈現出均衡的兩位數增長，由偏頭痛和Vraylar推動，而肉毒桿菌美容領域持續強勁的增長抵消了美國通膨對我們的填充劑和身體塑形產品組合的部分影響。

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預期為 13.78 美元至 13.98 美元，中間值成長超過 17%。說完這些，我將把電話轉給傑夫，請他對我們的商業亮點發表更多評論。傑夫？

Thank you, 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，里克。我對我們的治療產品組合的發展勢頭感到非常高興，包括我們在新產品和最近適應症發布方面取得的持續進展。首先介紹我們的免疫學產品組合，其總收入為 72 億美元，營運成長率為 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.

Humira 全球銷售額約為 54 億美元，以營運基礎計算成長 6.8%，其中美國市場成長 9.6%，但國際績效部分抵銷了這一成長，由於生物相似藥的競爭，國際市場營運收入下降 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。全球營收超過 12 億美元，季增 33%。我們繼續提昇在牛皮癬領域的領導地位，Skyrizi 在美國生物市場的總處方份額已增加到約 26%，這得益於新患者和轉換患者的使用份額目前接近 50%。

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.

我們也在日本、德國、法國、加拿大和澳洲等 23 個主要國際市場取得了遊戲市場份額的領先地位。乾癬性關節炎也大大增強了 Skyrizi 的勢頭，目前該藥物已在 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.

在美國皮膚病學領域，約 30% 的患者同時出現皮膚和關節問題，Skyrizi 的患者份額已達到近 20%。我們還推出了用於治療風濕病學 PSA 的 Skyrizi，我們看到該藥物的使用率很高，這推動了其份額加速成長。

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了用於治療克羅恩病的 Skyrizi，這是該領域六年來首個獲得批准的新生物製劑，該領域仍然存在大量未滿足的醫療需求。

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一種高度有效和差異化的治療選擇，包括透過新穎和不頻繁的給藥提供有意義的內視鏡改善水平的潛力。預計未來幾個月內，針對此適應症的管理式醫療服務將大幅增加。

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.

現在談談 Rinvoq，我們看到其在每項核准適應症方面都呈現良好的勢頭。全球銷售額達 5.92 億美元，季增逾 27%。處方藥和 RA 依然保持強勁，在美國佔 5.8% 的總市場份額，在主要國際市場佔據約 6% 的市場份額。

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 目前在美國實現了約 13% 的 RA 份額。在 PSA 中，Rinvoq 繼續呈現良好的上升趨勢，尤其是在房間細分市場，商業訪問現已與 RA 持平。我們最近也獲得了 FDA 對僵直性脊椎炎治療的批准以及歐洲對非放射性中軸脊椎關節炎治療的批准，進一步擴大了 Rinvoq 在風濕病學領域的潛力。

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.

在異位性皮膚炎方面，新患者的開始狀況符合我們的預期，Rinvoq 的患者份額達到了十幾歲。 AD 領域強大的商業准入（目前也與 RA 和 PSA 領域相當）預計將在今年剩餘時間內大幅增加這一滲透率極低的市場的付費處方量。

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。最近，我們剛剛獲得歐洲對同一適應症的批准。美國的商業化管道正在強勁成長，我們看到，新的患者開始接受治療。

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 領域的批准情況的反饋是積極的，尤其是考慮到我們在 UC 開發計劃中展示的非常高的緩解率和內視鏡改善率。 Rinvoq 在 UC 中的目標患者群體相當龐大，其中近 50% 的患者目前正在接受或曾經使用過 TNF 療法。

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.

現在談談血液腫瘤學，其總收入為 16.5 億美元，營運收入下降 7.9%。 Imbruvica 全球營收約 11 億美元，下降 17.1%，低於我們的預期。美國的 CLL 市場仍面臨挑戰，新患者數量與疫情前的水平相比下降了兩位數。您可能還記得，我們​​最初的 2022 年 Imbruvica 銷售指引預計市場將部分復甦，但不幸的是，我們尚未觀察到這種情況。事實上，最新數據顯示，與去年相比，美國新患者數量實際上下降了個位數。

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復甦是明智的。因此，我們將從 2022 年指引中刪除這項假設。此外，其他 BTK 抑制劑以及我們自己的 Venclexta 等新療法的競爭日益激烈，也繼續降低 Imbruvica 在新患者中的份額，尤其是在一線 CLL 領域。儘管競爭壓力日益增大，Imbruvica 仍佔據 CLL 所有治療領域總市場份額的領先地位。

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 全球銷售額為 5.05 億美元，以營運基礎計算成長 21.2%。在 CLL 方面，我們繼續看到美國和所有主要國際市場的份額成長。我們也看到反洗錢業務持續表現強勁。 Venclexta 目前已在 80 個國家獲得批准，在許多市場已被視為不適合接受強化化療的第一線 AML 患者的新治療標準。

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.

因此，我們看到，在我們推出產品的各個國家，市佔率都在不斷攀升。在神經科學領域，收入超過 16 億美元，營運成長 15.2%。 Vraylar 再次強勁成長。銷售額為 4.92 億美元，按營運基礎計算成長了 13.9%，反映了美國非典型抗精神病藥物市場的份額持續成長。

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中，預計將於第四季度獲得 MDD 批准。這是一個潛在的巨大跡象，代表我們對 Vraylar 的當前預測將出現增量上行。

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 仍然是治療急性偏頭痛的口服 CGRP 藥物市場領先，營收為 1.85 億美元，較上季成長 34%。當我們考慮付費和橋接量時，QULIPTA 在美國預防性 CGRP 類藥物中繼續增加其領先的新品牌份額。我們在擴大商業通路方面繼續取得良好進展，這將支持 QULIPTA 在今年剩餘時間內實現強勁的銷售成長。我們也正在尋求 QULIPTA 的商業批准，將其作為美國慢性偏頭痛患者的預防性治療藥物以及歐洲的新療法。

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.

有可能進一步增強我們的競爭產品形象和長期成長機會。 BOTOX Therapeutic 在慢性偏頭痛及其它適應症的治療方面也表現良好，總銷售額達 6.78 億美元，營運利潤成長 14.5%。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正在實現強勁的收入成長。接下來，我將把電話轉給湯姆，請他對我們的研發計畫提出更多評論。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 Skyrizi 和 Rinvoq 發炎性腸道疾病計畫中進行了幾項值得注意的管道更新。我們最近獲得了 FDA 批准 Skyrizi 用於治療克羅恩病，我們對該標籤感到非常滿意，它反映了 Skyrizi 作為這種疾病的誘導和維持治療所展示出的強大益處風險特徵。

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.

根據其特性，我們相信 Skyrizi 將成為克羅恩病患者的高效差異化治療選擇。我們針對克羅恩病的 Skyrizi 的監管申請仍在歐洲接受審查，預計將在今年年底做出批准決定。

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.

此外，在發炎性腸道疾病領域，我們最近獲得了歐洲批准使用 Rinvoq 治療潰瘍性結腸炎。我們很高興能為患有這種常常使人衰弱的疾病的患者帶來這種新的、高效的口服藥物。

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.

本季度，我們也完成了 Rinvoq 治療克羅恩病的註冊項目，並報告了我們第三階段維持研究的正面頂線結果。我們最近提交了 Rinvoq 用於該適應症的監管申請，預計明年將收到批准決定。

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.

一旦獲準用於治療克羅恩病，Rinvoq 將完成 HUMIRA 涵蓋的所有主要風濕病和胃腸道適應症以及異位性皮膚炎的開發項目。我們臨床計畫中產生的數據的強度應該使 Rinvoq 成為這種廣泛適應症範圍內高度差異化的治療方法，並使 Rinvoq 能夠長期為 AbbVie 帶來巨大價值。

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 用於治療非放射學中軸性脊椎炎已獲得歐洲批准，這完善了 Rinvoq 在風濕病學領域的應用範圍。現在轉到我們的腫瘤學產品組合，我們在產品線的各個階段繼續取得優異進展。

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，我們展示了 II 期研究中大型 B 細胞淋巴瘤擴增隊列的結果，該研究評估了 epcoritamab 對接受過至少 2 種先前治療的患者的效果。在這項研究中，epcoritamab 耐受性良好，並產生了非常深遠和持久的反應，並且對於治療高度難治的大 B 細胞淋巴瘤患者俱有挑戰性。

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，並基於數據的強度，我們打算在今年稍後提交監管申請，以加速批准 epcoritamab 用於治療復發/難治性大 B 細胞淋巴瘤患者。我們預計批准決定將於 2023 年做出。

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.

我們在 Venclexta 適應症擴展計劃方面繼續取得良好進展，並預計在今年下半年看到針對 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，我們在先前的臨床研究中已經看到了該族群的非常有希望的結果，Venclexta 顯示出較高的總體反應率和延長無惡化存活期的顯著趨勢。

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.

我們所看到的療效水平表明，t(1114) 患者可能對 Venclexta 特別敏感，並且該藥物有可能成為多發性骨髓瘤市場中重要的生物標記驅動治療選擇。

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，在成功完成第三階段慢性偏頭痛預防研究後，我們向 FDA 提交了 QULIPTA 治療慢性偏頭痛的監管申請。慢性偏頭痛的定義是每月頭痛天數為 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，影響近 10% 的偏頭痛患者，嚴重影響他們的生活品質。如果獲得批准，這將成為 QULIPTA 的另一個差異化特徵，因為它將是唯一獲準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.

我們也提交了慢性和發作性偏頭痛 III 期預防研究的數據，以支持美國以外市場的監管申請。我們預計美國和歐洲將於 2023 年做出批准決定。本季度，我們在美國提交了 ABBV-951 的監管申請，這是我們用於治療晚期帕金森氏症的新型皮下左旋多巴卡比多巴輸送系統。

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.

這種創新的輸送系統有可能成為晚期帕金森氏症患者的變革性治療選擇，透過微創非手術給藥提供類似 Duodopa 的療效。

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.

我們也預計今年稍晚在歐洲提交監管申請，預計美國和歐洲將於 2023 年做出批准決定。

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，我想提供一些有關我們擁有新數據的一些早期項目以及我們正在開發的推進中的項目的最新進展。

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，我們最近在評估 Rinvoq 治療系統性紅斑狼瘡（一種自體免疫性多系統疾病）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發作次數的減少。

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長期數據，這將使我們能夠決定是否將 Rinvoq 推進至狼瘡治療的 III 期。在腫瘤學領域，我們擁有一系列針對實體腫瘤的有前景的早期項目，我們開始從幾個項目中看到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，進而增強腫瘤微環境中的T細胞效應功能。這會重新活化針對腫瘤的免疫系統，增強 PD-1 抑制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 期計劃中，我們將 ABBV-151 與 PD-1 檢查點抑制劑結合，用於治療對 PD-1 有抵抗力或復發的癌症患者，並對 PD-1 無反應性腫瘤中的這種組合進行評估。根據我們在多種實體腫瘤的劑量擴展組中看到的初步療效，包括隨時間的加深反應和延長的持久性，我們最近宣布了 ABBV-151 的概念驗證。

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.

我們計劃對幾種實體腫瘤進行 II 期研究，首先是尿路上皮癌，我們還預計今年晚些時候將在其他實體腫瘤適應症中獲得更多數據，包括結直腸癌，這可能使這種難以治療的癌症類型的研究得到進一步擴展。

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.

我們還將進行新的研究，探索更廣泛的實體腫瘤，其中基於腫瘤組織分析表明 GARP 是關鍵的免疫抑制途徑。我們的下一代 cMet ADC ABBV-400 也取得了巨大進展，其新興臨床數據對多種實體腫瘤的治療非常有前景。

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 Teliso-V，一種使用微管蛋白抑制劑有效載荷的 cMeT ADC。 Teliso-V 因治療 cMet 過度表現水準高的肺癌亞型患者而獲得突破性療法認定。

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 的毒素彈頭使用了更有效的拓樸異構酶抑制劑有效載荷，類似於用於治療大腸直腸癌的化療藥物伊立替康。透過使用具有不同彈頭的 ADC 來靶向 cMeT 陽性腫瘤，我們相信可以擴大可使用 cMet 療法的實體腫瘤範圍。

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 期計畫中，我們看到晚期大腸直腸癌患者的良好反應，這些早期療效訊號仍然令我們感到鼓舞。總而言之，我們在今年上半年的各個階段都取得了巨大進展，並且我們仍有望在 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，請他對我們的第二季業績和財務前景發表進一步評論。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。 AbbVie 第二季的表現證明了我們多元化投資組合的實力。儘管 Imbruvica 的市場動態、通膨上升和美元走強，但新產品和新推出的適應症帶來的動力使我們能夠維持我們的獲利前景。

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，較上年增長 11.2%，比我們的預期中位數高出 0.11 美元。這些結果包括收購 IPR&D 費用帶來的 0.14 美元不利影響。

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，扣除外匯帶來的 1.6% 不利影響，以營運基礎計算成長 6.1%。調整後的營業利潤率為銷售額的51％，比上年提高了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.

其中包括調整後毛利率佔銷售額的 84.7%、調整後研發投入佔銷售額的 11%、獲得知識產權與開發費用佔銷售額的 1.8% 以及調整後銷售、一般及行政費用佔銷售額的 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%。談談我們的財務前景。我們確認全年調整後每股收益預期在 13.78 美元至 13.98 美元之間。該每股收益預期並不包括第二季後可能產生的收購知識產權與開發費用估計。

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，反映出營運成長率為 6.5%。以當前匯率計算，我們預計外匯將對全年銷售成長產生 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.

本指南包括以下更新的假設。我們現在預計 Skyrizi 全球銷售額約為 48 億美元，由於強勁的市佔率表現，將增加 4 億美元。對於 Imbruvica，鑑於 CLL 市場缺乏復甦且競爭日益激烈，我們現在預計全球收入約為 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％。展望第三季。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.

以當前匯率計算，我們預期外匯將對銷售成長產生 2.1% 的不利影響。我們預計調整後的每股盈餘將在 3.55 美元至 3.59 美元之間。本指引不包括本季可能產生的收購知識產權與開發費用。

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，本季我們再次取得了強勁的業績，包括新產品和最近推出的適應症帶來的有意義的貢獻。鑑於我們業務的發展勢頭以及產品線的進步，我們已為長期發展做好了準備。說完這些，我就把電話轉回給 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，羅布。我們現在開始回答問題。為了在通話的剩餘時間裡聽取盡可能多的分析師的意見，我們要求您將問題限制為 1 或 2 個。接線員，我們將回答第一個問題。

Our first question is Andrew Baum, Citi.

我們的第一個問題是花旗的 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對 HUMIRA 在美國預期發展軌蹟的指導範圍，假設您已經完成與醫療保險和商業的合同，您能否就 '23 甚至 '24（聽不清楚）兩年期合同提供進一步的指導？

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?

第二，關於抗 GARP 單株抗體的一個問題，您花了很長時間對其進行優化或推進。我只是好奇，考慮到其他 TGF β 標靶藥物的失敗，您是否使用任何分子標記來將風險降至最低，特別是在使用 CMS 4 的結腸直腸癌或總人群的一個亞群中？

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者那裡。有建議說它（聽不清楚）再告知生物標誌物？

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，這是里克。感謝您的提問。我來介紹第一個，然後湯姆可以介紹第二個。因此，正如我們之前所指出的，我們現在正在與管理式醫療組織和 PBM 進行談判，以確定我們在 2023 年的 Humira 合約地位。

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.

在正常情況下，您都會經歷這樣的情況。事情正在按照我們預期的那樣進展。我想說我們現在正處於這個過程的一半。我預計它將在第三季末或第四季初完成。從這一點來看，這是完善我們 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，我們在 2023 年對 Humira 的處方地位，這將幫助我們清楚地定義它的數量方面。一切進展順利，這將是我們改進模型的重要部分。

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，隨著我們在這過程中不斷前進，我們將有能力完善現有的模型。現在，要記住的一件重要的事情是價格是這裡的另一個關鍵因素。

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.

並且，在實際事件發生之前，我們無法知道真實的價格。因此，我們將對該價格做出假設。我認為這些都是有根據的假設，但他們只是假設而已。因此，在我們看到 2023 年情況開始顯現之前，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，將有更多生物相似藥進入市場。因此，隨著我們獲得更多信息，我們可以提供更清晰的解釋，我們肯定會盡力做到這一點，但我認為這就是我們現在的情況。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，我會嘗試將問題分解成不同的部分，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-β 資產要麼作用於針對活性形式 TGF-β 受體的抗體，要麼作用於細胞中循環的 TGF-β 本身。但是 GARP 在 TGF-beta 釋放之前會阻斷其非活性形式。 我們相信這實際上也是一種差異化機制，它使得對腫瘤中 TGF-β 發生的變化具有特異性，而不是對身體其他系統的影響。一開始，我們認為已經有人發表過文章稱存在非常好的 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 簽名與 TGF-beta 簽名遵循相同的軌跡。這在所有表達這些途徑的實體腫瘤或敏感腫瘤中都很常見。這是一種非常常見的免疫抑制機制。這就是為什麼人們和我們對此感興趣。

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患有熱腫瘤但對 PD-1 沒有反應的人通常具有更高的 TGF-beta 特徵，至少從已發表的研究來看是如此。

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.

因此，我們認為這就是這些熱腫瘤患者對藥物沒有反應的原因，我們最初的許多臨床策略實際上就是針對 PD-1 復發或具有抗藥性的熱腫瘤。

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.

我們認為透過這種組合我們可以增強 PD-1 檢查點反應。我們沒有看到單一療法的效果，但是聯合療法的效果我們卻看到了。這就是為什麼我們的第一批資料集和擴展，就像我剛才在尿路上皮癌中討論的那樣，這個計畫啟動得比較早，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，才能得到反應。

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.

我們再次在多種腫瘤類型中看到了這些反應，並且正在取得進展。同時，如果我們能將其帶到結腸，我們也可以在冷腫瘤中看到 TGF-β 和 GARP 的相同特徵，但由於它們對腸內腫瘤沒有反應，我們不確定我們是否會得到反應——我們會得到臨床反應。

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，我們確實看到了冷腫瘤的一些反應。它們會隨著時間的推移而發生，（聽不清楚）有時腫瘤似乎會穩定 3 個月，甚至 6 個月。然後你就會看到這些回應出現。

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。非常不尋常。這些是患有晚期疾病的患者，在第一階段的研究中預後非常差，因此我們看到了一些，我想說——我們有時會在學術專欄中說是特殊的反應者。因此我們決定擴大規模。

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.

因此這些數據集比較新，並且正在發生。我大概在今年底就會有數據。但是的，我們已經看到——我們已經看到了對這種組合的反應。並回答你的問題。因此，我們所看到的特徵不是 CMS 或基於腫瘤組織學的特徵。 它是我們在腫瘤中可以測量的更多發炎反應的特徵，它既與具有殺傷作用的發炎 T 細胞有關，也與抑制性 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，我們會繼續調查此事。我今天還不能全部回答你們的問題，但看到這個計畫的發展確實令人興奮。

Thanks, Andrew.

謝謝，安德魯。

Our next question is Terence Flynn with Morgan Stanley.

下一個問題是摩根士丹利的特倫斯弗林 (Terence Flynn)。

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.

對我來說也許應該是 2。只是想確保您能維持 2022 年 59 億美元的美學指導目標。羅布，我沒有聽到你這麼說，所以我假設那是重申，只是根據你在美國看到的 Juvederm 的情況。

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.

然後我的第二個問題更像是一個戰略問題，里克。我知道您仍在與Humira討論2023年的事情。但是，當您考慮提供指引更新時，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一些對 2024 年的展望，因為我認為投資者現在正在討論的是，如果影響的可能性在 24 年更大，我們應該如何看待 24 年與 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.

所以只是想知道您現在從戰略上是如何考慮這個問題的，不尋求指導，更多的只是思考過程。

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 Terence，我會回答這兩個問題，然後如果 Rob 有什麼想補充的話，他當然也可以加入。正如我們所指出的，我們正在維持美學指導。當然，我們看到毒素業務方面表現良好、強勁，我們預計這種情況將會持續下去。

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.

正如您所注意到的，當我們看一下填充料業務時，本季的業務比歷史上要低。我認為這是由幾個問題引起的。這無疑是由美國以外的中國-俄羅斯問題所推動的。因此與去年相比，這是一個困難的比較。但我也想說，我們已經看到了一些跡象，表明該業務可能面臨通膨壓力，或者有被壓抑的度假需求。

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，Carrie 當然可以更詳細地講解。但我認為，從整體來看，我們現在願意維持這項指導方針。我們相信 BOTOX 將繼續表現良好。 顯然，我們正在採取更多措施來推動毒素業務的發展。目前的物價水準對通膨壓力應該不太敏感。我認為毒素的價格約為 500 美元，對的，加里。而填充物的價格幾乎是這個數字的兩倍，甚至可能略高於兩倍。因此顯然，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，這就是背後的原因。

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，我們會發現如果我們最終遇到問題，我們多元化的投資組合將有足夠的機會彌補任何潛在的不足。這就是我們樂意維持該指導的原因。 我認為，我們需要觀察更多的時間才能準確了解美國通膨的影響程度。

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 年的更新以及 24 年的潛在更新有關。我認為您的描述方式是準確的。 當我們獲得更多資訊時，我們會盡力提供。當我們確定第四季度電話會議中的情況時，我們肯定會為您提供有關 2023 年將發生什麼的指導。 我認為這不是一個好的期望。但可以肯定的是，我們可能會更清楚地了解當時我們的合約狀況如何，以及這將如何轉化為我們的想法。如果我們能夠在更大程度上完善模型，我們肯定會提供這一點。

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.

至於 2024 年，當然，我不會——我們現在還不宜談論 2024 年。我認為這不太可能，因為並非所有這些合約都是兩年合約。因此，您實際上並不知道此時您的音量處於什麼位置。 正如我所說的，你不會知道特別是在年中的時候價格會是多少。所以我認為，這些都是了解預測走向的重要因素。我想說的是，總的來說，我們對我們所處的承包地位感到滿意。

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.

然後我想說的另一件事是，我知道投資者真的想嘗試在 23 年和 24 年之間模擬這種情況。我了解你為什麼想這麼做。當然，我們顯然希望盡最大努力做到這一點。

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.

但當你退一步並真正看看 AbbVie 的表現，你就會知道你如何評價 AbbVie 以及 AbbVie 未來的發展方向。它與 Humira 以及 23 年和 24 年之間的曲線形狀關係不大。當然，到 24 年底，我們應該在 Humira 的尾部達到一定程度的穩定。

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%.

AbbVie 關注的是其他產品，例如 Skyrizi、Rinvoq、Vraylar 和（聽不清楚）美學業務 QLEPTA，這些將成為推動其發展的動力。因此，如果你想要專注於某件事，而我們內部關注的就是那個潛在的成長引擎，無論 Humira 受到什麼侵蝕，在達到某種穩定水平之前最終遭受什麼侵蝕，它都會出現，而尾部就是那些資產，然後是它從管道中出來的東西。這些是實現25%至30%成長率的關鍵因素。

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.

這就是我們要做的——我想說的是，我們顯然正在盡最大努力管理 Humira。但這是我們團隊關注的部分，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.

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 Rick 和 Jeff 需要更深入地探討一下 Humira 的問題。所以您說競爭對手的定價將是明年的關鍵未知數。因此，當您今年簽訂合約時，對於明年，當 PBM 意識到生物相似藥的定價為 X 或 Y 時，這些合約從定價的角度來看有多嚴格或靈活？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，讓我嘗試一下，當然，傑夫更接近這個目標。所以 Jeff，如果你想添加任何內容，請隨意添加。通常，對於 Humira 等資產的新合同，您是在簽訂處方集合約。

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.

還有數量要求或其他類型的要求。我認為，明智的做法是假設生物相似藥將包含在這些合約中，無論是一種還是多種與 Humira 共存的藥物。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.

所以我想說——當情況變得不確定時，你必須決定如何處理它。維護您想要維護的磁碟區類型。我們一直說，我們在美國採取的策略與我們在國際上的策略類似，那就是在盡可能高的利潤水準上保持盡可能多的銷售量。

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?

這就是我們將要採用的邏輯。但這並不意味著我們不需要對 Humira 的市場價格做出反應。傑夫，您還有什麼要補充嗎？

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——里克，從這些談判的進展情況以及我們對 23 年前景的看法來看，這是一種非常合理的方式。我的意思是，就我們的看法而言，真正重要的是兩種大情況，即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，我們將排除生物仿製藥。 這基本上就是我們在完善 23 年模型時所考慮的價格和數量。這就是我們整個夏天和秋天要做的工作。

Next question is Gary Nachman with BMO Capital Markets.

下一個問題是 BMO 資本市場的 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?

因此，Skyrizi 在第二季度表現非常強勁，而且你很好地提高了預期。到目前為止，您從乾癬性關節炎適應症中獲得了多少益處？您期望克羅恩病今年會帶來什麼影響？這些對上調後的指導價有多大影響？

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，您是否會重新審視 Skyrizi 的長期指導？然後只是關於 hem/onc 特許經營權。您是否保持基礎設施完好無損，為新產品的投入做好準備？也許您可以談談您看到的 epcoritamab 和 navitoclax 等產品的近期機遇，這些產品在多大程度上可以貢獻並潛在地抵消 Imbruvica 帶來的一些壓力？

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。是傑夫。謝謝你的提問。所以你的直覺和觀察是正確的。這裡 Skyrizi 的巨大動態變化，主要是您所看到的來自銀屑病關節炎適應症。並且顯然看到了非常非常大的連續走勢。讓我介紹一下我們正在關注的事情。

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，我們在銀屑病領域總體份額排名中佔有越來越大的空間，也就是銀屑病加上 PSA。因此，我們的 TRx 總份額為 26%，並且正在穩步上升。這是由 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.

首先，請記住 PSA 指示，我們實際上是最後一種沒有該指示的大型產品。首先，它開始在皮膚病學領域產生非常積極的影響。正如我所提到的那樣，大約 30％ 的患者同時患有皮膚和關節疾病 - 因此，儘管我們的牛皮癬患者比例最高，但我們的牛皮癬患者比例實際上較低，因為我們沒有受到具有這種指徵的關節的影響。

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，正如我所強調的，我們的整體皮膚病業務立即得到了非常快速的成長。其次，對績效具有策略重要性的是我們能夠在風濕病學領域推出 Skyrizi 的 PSA 適應症。因此，它開始與 Rinvoq PSA 適應症一起工作，並且風濕病部分是皮膚病部分的 3 倍大。

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，在談到克羅恩病之前，就我們在兩個大領域的發展勢頭而言，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，Skyrizi 是一種非常特殊的產品，劑量非常獨特，非常穩定，療效令人難以置信，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.

現在查看數字等等還為時過早。但這一切都與羅布所說的加薪有關。

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，這是羅布。僅提供指導。所以如果你還記得，今年早些時候，我們被問到這個問題，我說 Skyrizi 的 PSA 今年將貢獻約 2 億美元。鑑於我們看到的 PSA 非常不錯的成長，按照指導範圍來看，現在這個數字可能更接近 4 億美元。

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.

但這次指引上調的部分原因也在於牛皮癬領域強勁的市佔率表現。因此它包括兩者。就克隆氏症而言，情況並沒有改變。我們今年已投入約 1 億美元擴大克隆氏症的治療管道。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.

或許我也可以回答第二個問題。當然，新資產是我們血液/腫瘤業務成長故事中非常重要的一部分。當然，正如我所提到的，我們仍將繼續在世界各地推廣 CLL。 我們擁有越來越多令人印象深刻的數據，特別是在不適合使用 Venclexta 的第一線治療人群中，我們擁有適合使用 Venclexta 一線治療的人群 5 年的數據。我們對骨髓瘤數據感到鼓舞，就 t（1114）的生物標記驅動方法而言，它非常獨特，Navitoclax 實際上是骨髓纖維化治療領域的首批新進入者之一，而就該市場而言，實際上只有 [RUX]。

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 的數據越來越令人鼓舞，因為它提供了簡單的皮下注射非常快速的方法，可以將這種藥物用於後期治療，然後用於一線治療。因此，我們感到非常鼓舞，儘管我們看到 Imbruvica 面臨一些壓力，但 Venclexta 基礎的新適應症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.

然後我們開始利用這些近期的血紅素資產進行建設，並且對於我們所看到的實現這一目標的可能性感到非常鼓舞。

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

下一個問題來自摩根大通 (J.P. Morgan) 的克里斯·肖特 (Chris Schott)。

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?

首先，我只是想回顧一下美國真皮填充劑市場的動態。我想具體來說，您能否量化我們看到的疲軟程度——或者同比下降是由於去年的促銷活動造成的，還是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.

我想在同樣的背景下，您是否看到歐洲業務出現疲軟跡象？我們只是想了解您所談論的通貨膨脹或對該業務的經濟敏感性的影響程度。

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.

我的第二個問題是思考隨著生物相似藥 Humira 進入市場，Rinvoq 和 Skyrizi 的處方集和定價動態。我想，您是否預料到，或者您是否透過討論聽說，當我們考慮價格下降時，付款人對這些產品的看法是否發生了重大轉變，這顯然是該領域最大的產品類型。

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 Carrie。我來回答您關於 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，非常成功，增加了銷售領域的銷售額，這使得與去年同期的銷售額相比更具挑戰性。

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.

所以這是關鍵驅動因素。但正如你所說，還存在這種影響，經濟影響表明消費者行為發生了一些早期變化。考慮到可支配收入面臨的通膨壓力，這確實並不奇怪。正如里克所說，由於一些原因，填充物市場對此比毒素更敏感。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，其價格接近 1,000 美元，而毒素的價格為 500 美元。此外，從患者動態和治療動態來看，填充物業務的性質與毒素不同，並且填充物的治療間隔比毒素的治療間隔更長，這有點像每年幾次的更常規的治療模式。

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，患者群體也不同。當您考慮毒素患者群和那些擁有化妝品的患者群時，大多數患者群都是持續性患者，而不是更依賴新患者的獲取。因此，當我們考慮第二季填充劑市場減速時，這些就是我們考慮的一些因素，但儘管市場已經放緩並且儘管第二季度表現不佳，但我們仍然預計美國 Juvederm 下半年將實現正成長。 第四季度確實等待更多，因為我們將在第四季度推出 2 種新填充劑，這兩種新填充劑將使我們進入 HA 填充劑的增量類別，包括下顎線和皮膚質量，這將有助於在年底推動一些增量需求。

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.

至於您提到的對美國以外地區經濟的影響，我們正在密切關注，但我們尚未在美國以外地區看到這種影響。

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。謝謝。我們 — — 我們沒有看到 Skyrizi 和 Rinvoq 面臨重大壓力。現在我們總是與付款人進行討論，研究我們的承包策略。但我認為我們應該依靠我們所掌握的關於這兩項主要資產的臨床證據。

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，我們已經與其他主要競爭對手就 Skyrizi 進行了 4 次正面交鋒試驗，結果發現，無論是 IL-17，還是 Humira（未來有一天會成為生物仿製藥），還是 STELARA 等等，我們都具有明顯的優勢。

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，僅從其純粹的表現和勢頭來看，它顯然是一筆傑出的資產。在克隆氏症領域，我們將率先開拓新領域並在那裡建立市場。我認為，就 Rinvoq 而言，在某種程度上，只有一種其他 JAK 抑制劑不具備適應症範圍，那就是 Xeljanz。而根據口服監測數據，Xeljanz 已經受到嚴重損害。

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，就我們建構、保護和發展 Skyrizi 和 Rinvoq 進入下一階段發展的能力而言，我們非常有信心我們有能力做到這一點。

Our next question is from Steve Scala, Cowen.

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，里克，過去你曾列出過 4 個將決定 Humira 在 2023 年發展軌蹟的因素。

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.

但後兩家公司在這些生物相似藥方面具有競爭力，您說這部分是可互換性，也是生物相似藥供應市場的能力。因此，這兩個因素、第三和第四個因素是不會波動的，想必您現在對此已經有一定的了解。

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什麼不尋常的事情。在討論中，與付款人的互換性有多重要。第二個問題是，如果我錯過了，我很抱歉，但是有沒有關於 TNF 類固醇結合物的任何更新，今年是否仍預計會有 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。這是里克。我將介紹第一個。而 Roopal 可以覆蓋第二個。所以你是對的。這就是我在一兩次會議前所描述的四個變數。我想說，當你考慮可互換性時，我認為你必須在不僅可互換性的背景下考慮它，而且還要考慮當今最接近 Humira 的概況是什麼？

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相似藥，並且非常清楚其概況。我想說的是，要獲得一個可互換的、與目前市場上占主導地位的 Humira 一致的配置文件，這可能會在 2023 年夏天實現。

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 種生物相似藥。他們的個人資料看起來像那樣。這將使組織的轉變變得更容易一些。所以我認為這將發揮重要的作用。

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，該資料的外觀沒有任何變化。顯然，供應是一個重要方面，任何考慮對 Humira 的立場做出重大改變的人，都會希望確保他們選擇的公司有能力大規模生產 Humira，並且能夠持續地做到這一點。

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.

所以我想說有些球員顯然有能力做到跟我們一樣的事。當然，沒有人能像我們一樣，或在任何地方接近我們。但我認為，還有很多小參與者，供應將是一個重要方面，並且會在一定程度上限制其對廣泛市場產生影響的能力。

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，我們正在與他們討論這些事情。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。正如您所說，154 是我們的抗 TNF 結合類固醇，它能夠將類固醇直接遞送至發炎細胞。因此，我們確實在 II 期臨床試驗中對數百名患者進行了研究，我們仍預計今年稍後將獲得 [大麻]，然後在明年追蹤進一步的數據。

Our next question is Chris Raymond, Piper Sandler.

下一個問題是派珀桑德勒 (Piper Sandler) 的克里斯雷蒙德 (Chris Raymond)。

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。也許其中一個是更廣泛的政策，然後另一個可能更為詳細一些。所以對 Rick 來說可能是第一個。我知道你們非常密切關注醫療保健政策。這只是參議院民主黨在和解法案中最新的有關藥品定價的語言。

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.

從價格控制的直接影響來看，這些規定表面上看起來相當容易管理，但有人擔心這只是更大規模價格控制措施的開始。如果你們對此有任何想法，我將不勝感激。

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?

然後也許是關於 ABBV-951 的一個更詳細的問題。我知道你們還沒有就此或關於 Duodopa 提供具體的指導，但運動障礙 KOL 似乎對 ABBV-951 給予了很大的認可，認為它在克服 Duodopa 的沉默方面有了真正的進步。如果獲得批准，我們應該如何看待 ABBV-951 與 Duodopa 的比較？

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。我來回答第一個問題。我的意思是，如果你看看現有的藥品定價方案，你會發現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的問題。我認為，如果我看一下該法案，並且我假設其中有些內容能夠獲得通過，那麼它將與參議院財政法案中的內容保持一致。

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，看起來是這樣的，但隨著我們的進展，顯然會發生一些變化。如果我從總體上看，我會說其中有一些積極的東西。當然，最值得注意的是，2,000 美元限制了患者自付費用並能夠平滑支付。我認為這是提高負擔能力的重要一步，特別是對於參加聯邦醫療保險 D 部分的患者而言，因此我們一直支持這一點。我們一直表示，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.

但我想說，總的來說，這項法案的負面影響遠大於正面影響。坦白說，我認為，儘管這可能不是短期的，從財務角度來看這並非一個挑戰，但我認為這項法案的長期影響相當重大。

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.

它們實際上圍繞著其中的所謂談判條款及其實施方式，特別是對於小分子而言。如果您熟悉它，那麼它本質上說的就是 CMS 或者我們假設 CMS 在某個時間點有能力就一組藥品的價格進行協商。

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.

到那時，他們就能擁有一大批可以進行談判的藥品了。關鍵問題是，從本質上講，他們有充分的自主權來決定藥品的價格。

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.

我不會稱之為談判，因為製造商唯一的選擇就是接受 95% 的收入罰款，或本質上接受 95% 的折扣。所以這不是一場談判。我們應該直呼其名。如果語言保持不變，他們基本上就會實施價格控制。

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對這個行業進行投資創新。如果以小分子為例，我將帶您了解一個例子，說明我將在這裡提出的計劃。以小分子藥物為例，規定在首次批准後的第 9 年，CMS 有權就該藥物的價格進行協商。

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，我們該行業該如何開發腫瘤藥物呢？監管機構通常要求我們做什麼才能開發我們的腫瘤藥物。嗯，他們通常會要求你這樣做，而我們通常會做的是，我們會治療所有現有療法都失敗的患者、四線患者、五線患者。 無論我們服用什麼藥物，我們都會確定對患者群體是否有積極的效益風險。

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.

如果我們發現確實如此，那麼我們就會尋求批准該藥物用於該患者群體，以便這些患者能夠從該藥物中受益。然後我們開始向前線努力，那些難治性患者通常只是極少數患者，對嗎？ 而你永遠不可能只從那群患者身上獲得藥物回報。然後你努力爬到前線。或第二行，無論你最終在哪裡，這個過程通常需要 7 到 9 年，因為試驗的時間很長。因此從本質上講，透過這種方式，當你涵蓋更大的人群時，CMS 可以在一兩年內改變價格。

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.

但首先，你不可能知道回報是多少，那你該如何投資呢？二是，這確實會給你帶來負面壓力，使你不再繼續發展新的適應症。但最有害的是對於那些需要這些藥物或小適應症或晚期的患者。

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.

因為你面臨困境，無論對公司或病人來說，這都是一個可怕的困境。你面臨著一個兩難的情況：我是否選擇不為那些晚期患者尋求批准，這樣我就不開始計時，而是等到我更接近前線後再開始計時。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.

我想說，總的來說，這項法案有一些對病人有利的內容，我完全支持。但除非國會想要傷害患者並損害該行業的創新，否則他們需要改變這一部分。這沒有意義。這是目光短淺的。

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法來改變它。他們可以確定每年的底價或最高折扣，然後你就可以計算出該藥品的投資回報率，或者至少可以使其與 13 年來生物製劑的回報率保持一致。

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，這些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會受到影響。

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。所以這不是我說的話或業界所說的。事實上，如果有的話，我想說他們可能低估了影響的程度。

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得醫療保險的機會非常重要。但你不需要在過程中破壞創新模式。為了提供這一點。因此我希望我們能看到一些進展和理性的體現。

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。針對您的 ABBV-951，我是 Jeff。謝謝你的提問。因此我認為從全球角度來看，Duodopa 是一個價值約 5 億美元的品牌。當然，我們已經說過，我們相信 ABBV-951 肯定可以使這個數字翻倍甚至更多，我會告訴你我們為什麼這麼認為。

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.

如果你觀察晚期帕金森氏症患者，大約 85% 的患者在繼續服用通用口服藥物時會進入週期性發作，而藥物的療效會越來越低。他們真正能做的唯一一件事，也就是約 15% 的市場，即晚期帕金森氏症市場，就是轉向深部腦部刺激或 Duodopa，但你必須通過手術障礙。因此，家屬和患者不得不思考，我是否需要改善症狀和生活質量，我被迫思考，做胃部手術是否會在我的頭上或胃上開一個洞。這將是一個子立方體。因此，我們在市場調查中發現，至少有 40% 到 60% 的人不想使用 DBS 或 Duodopa。

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，我們認為這是我們開始擴展和創建新細分市場的一種方式，本質上是一個皮下細分市場，您不必承擔手術風險。正如您所提到的運動障礙中心，有許多專家對這個新選擇感到興奮，我們相信對於無需手術的患者來說，這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，這是羅布。正如傑夫所說，我的意思是，我們預計這將會擴大市場。在今年稍早的摩根大通會議上，我們確實給出了 ABBV-951 的最高收入預期超過 10 億美元。顯然，Duodopa 現在價值 5 億美元。如果你對它進行建模，顯然，我會說，Duodopa 上會有一定程度的 [管道化]，較小程度的管道化。但當你考慮 ABBV-951 和 Duodopa 的組合時，顯然，它將增加公司的收入並擴大市場。

It's Tim Anderson with Wolfe Research.

我是 Wolfe Research 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?

如果我可以回顧整個 23 對 24 的事情。我認為，過去你們曾說過，獲利將在 2023 年觸底，然後在 2024 年恢復成長。還是這是不可能的？

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 ABBY-154 化合物的抗體藥物偶聯物。我們知道時間安排仍在按計劃進行，但我只是感覺大家對這個項目明顯缺乏熱情，儘管它很新穎，但你們似乎並沒有提到太多，或者根本沒有提到。儘管它是免疫學領域中最關鍵的領域。那麼，在過去幾年裡，這種熱情是否已經消退了呢？

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.

那麼提姆，這是羅布。關於您的第一個問題，我們已經說過——我們討論的是這個 45% 的範圍，大約在正負 10% 之間。顯然，我們以歐洲類似物為例。在這種情況下，由於 1923 年和 2023 年的急劇侵蝕，您可以預期低谷將出現在 2023 年，並在 2024 年恢復增長。隨著事態的發展，我們會看到結果如何。

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24年有更多這樣的情況發生，那麼顯然您所有的成長品牌都會再獲得一年的成長。因此，在這種情況下，你的底線會有所不同。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.

當你以我們擁有的成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成長，這是業界領先的。在本世紀下半葉，我們的 LOE 風險敞口將達到業界最低水準。因此，我們著眼於長遠發展，並且我們對這項業務的前景非常看好。

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.

但就目前情況而言，我們給出的最新方向是預計第一年會出現侵蝕，即45%上下浮動10%，然後在24年恢復成長。我們顯然會根據明年的市場發展更新資訊。

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.

也許我會選擇這個。這是湯姆·哈德森。我是臨床免疫學家，我知道我們是如何使用類固醇的，它們可以產生非常深刻的免疫抑製作用，減少炎症，這通常用於患者出現的嚴重病例。

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.

因此，我們知道反應非常強烈，但也有很多副作用。我們面臨的問題一直是臨床上逐漸停止使用類固醇。因此，再次強調，TNF 等免疫調節劑和類固醇的組合有可能讓我們非常迅速地產生深層反應，從而消除免疫抑制。

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.

根據我們在第一階段臨床前研究中看到的數據，我們沒有在腦骨、皮質醇或其他物質中看到那些生物標記或副作用。所以我們已經證明了這一點，而且我們有很好的數據——其他的——這就是我的熱情。我們期望看到深度反應、持久反應且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.

我們的項目，我們已經證明了這一點，我們確實相信這個平台，我們正在為其他目標開發類固醇 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。 這些計劃正在推進中。我們認為這是免疫學領域的一個深刻平台，可以利用不同的生物學手段對不同特定免疫細胞類型進行非常有針對性的類固醇抑制，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記物，以進入其他特定的免疫細胞類型。當然，我們保持沉默是因為我們需要查看數據，所有研究都已完全招募完畢，實際上進展比我們預期的要快。且日期是隨機的。我們將在秋季看到數據，因為這是一項盲法研究。但熱情仍然存在。

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了對克隆氏症的研究。我們稍後會看到這些數據，但是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，我們相信使用 TNF 進行深度類固醇抑制實際上可能會為患者帶來新的解決方案。

Our next question is Geoff Meachem, Bank of America.

下一個問題是美國銀行的傑夫‧米切姆 (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.

非常感謝您的提問。我不想過多地討論Humira的問題，但我想問一下，我們本季在歐洲看到的Humira的4年趨勢是否符合長期趨勢。這是否仍然是一個很好的代理，或者你們如何看待 Humira 的尾部，只是考慮到我們在歐洲已經度過了 4 年，而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.

所以我想問您對美國後續情況的預期。

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，這是羅布。我來回答你的第一個問題。我們談到了 Humira 在歐洲的侵蝕情況，我們發現第一年的侵蝕非常嚴重，而幾年後侵蝕情況則比較溫和。在我們現在的建模中，可能最好的思考方式是第一年的深度侵蝕較為溫和。您將在第二年感受到年度化影響，但此後影響將變得更加溫和。

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 [第一波] 國家中，當我們看歐洲時，我們今年的收入水準相對於 LOE 之前的收入水準仍然佔比約 30%。這樣你就能了解四年後歐洲的狀況。顯然，當我們對美國進行建模時，它將來會更加具體，但現在，我們使用歐洲作為類比。

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看到的情況來看。它基本上是按照我們預測的那樣發展。因此，我們確實看到，在標籤改變後，部分醫生對 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，我們開始看到二線及 RA 的復甦。還有新的適應症，因為實際上我們將成為唯一具有 RA、PSA、AS 四大適應症和非放射學適應症的 JAK 抑制劑，最終將在秋季推出。 這只是增強了醫生的信心程度。這就是我們在現場感受到的。我可能會提到一些關於潰瘍性結腸炎的內容。我提到我們對潰瘍性結腸炎的開始感到鼓舞。所以我們在本季度看到了這一點，因為我們在四月初推出了它。我們看到 600 位獨特的胃腸病學家開始開處方，這非常有趣而且很好，具有積極意義。其中約有一半的客戶從未使用過 JAK 抑制劑。因此 Xeljanz 獲得了批准。

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，我們顯然看到這些客戶能夠理解 Rinvoq 相對於另一種 JAK 抑制劑的整體風險效益。因此，我覺得我們的溝通進展順利，而且我們在落實通話中強調的跡象時也看到了正面的回饋。

Our next question is (inaudible) with UBS.

我們的下一個問題是（聽不清楚）有關瑞銀的。

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.

另一個是關於'23 Humira 指導。您能否向我們介紹一下—在第三季末，您已經確認的合約或交易量佔比是多少？然後聽起來——當你獲得全年結果時，你仍然預計可能會發生有意義的變化。

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?

您能否確認這是一個公正的描述。然後就使用 AbbVie-154。您希望看到我們在年底獲得的第二階段數據是什麼？那麼，你需要超越什麼門檻才能繼續前進呢？

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，如果我們看看我們和 Rick 強調的討論，我認為它們的進展正如我們預期的那樣。通常它們在春末開始。你看，這些都是複雜的談判。它們會持續很多、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.

很多年後，我們至少會完成大型 PBM 談判，也就是 10 月之前完成的絕大部分談判。在某些情況下，您可能知道，付款人會公佈此資訊。但很多時候（並非總是如此），在免疫學和發炎領域，這些談判可能會持續更長時間，而且它們通常會在以前所謂的排除處方集中以 TBD 的形式發布。

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 所提到的那樣，我們將能夠看到 10 月份的交易量狀況。這是一個合理的假設。再次，我也不確定，因為生物相似藥談判非常複雜，這種情況以前從未發生過。

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 所強調的那樣，這是一種合理的思考方式，可以讓我們開始了解成交量組件。

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.

關於 ABBY-154 的問題，請聽聽 Roopal 的發言。與湯姆剛才講到的相吻合，我們希望看到的事情與我們在免疫學領域的發展一致，這肯定會提高護理標準。因此，設計此方案的方式是使用抗 TNF，然後直接輸送，以避免類固醇的全身副作用。所以你會看到湯姆所描述的那種連續打擊，也看到反應的深度。

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，一旦我們看到這類資訊以及從類固醇的角度看，代謝影響、骨骼影響等，我們就能很好地了解它在抗 TNF 之前的應用，即使在我們研究了 II 期研究中抗 TNF 治療失敗的患者之後。

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.

所以綜合起來，我們會很清楚知道該去哪裡。然後請記住，我們還將獲得有關多發性肌痛的風濕性肌痛的數據。這不是一種罕見的疾病，這些患者——其中許多都依賴類固醇，50％ 左右已經使用 3 年了，並且無法停用類固醇，也許有 1/3 的患者已經使用 5 到 6 年了。

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.

他們被困在類固醇中。因此，我們將看到能夠防止其發作的數據，並能夠減少其全身性類固醇劑量。因此，這個問題有多個方面，可能存在著許多機會，並且以後在克隆氏症中也會出現同樣的情況。

Thanks, Colin.

謝謝，科林。

Our next question is from Chris Shibutani with Goldman Sachs.

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.

如果可以的話，我有兩個問題。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。我認為 Skyrizi 記得您說過 75 億美元，其中約 60 億美元來自銀屑病綜合症。但目前你已經接近 50 億美元了。 那麼您能告訴我們您是如何看待這一點對長期思考有何影響的嗎？然後對於 epcoritamab，在整體治療範式中定位該治療。您如何看待這與 CAR-T 療法治療前後的治療方案的關係？

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，這是羅布。我來回答這個問題。所以，我們對 Skyrizi 持續強勁的表現感到非常鼓舞。我們仍有信心能夠實現或超越 2025 年的指導目標。現在請記住，我的意思是——華爾街也反映了這一點，華爾街的估值比 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.

話雖如此，我們並不打算頻繁更新該指南。顯然，我們會每兩年提供一次指導更新，或在發生事件或出現重大脫節時提供指導更新。因此顯然，如果華爾街的預測完全錯誤，我們會指出這一點。

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 的接受度感到非常高興。它清楚地展示了其推動 AbbVie 長期成長的能力，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。以及有關 epcoritamab 的問題。所以我不會詳細討論所有的數據點，我們已經在公共領域對它們描述過好幾次了。我想提醒你的是，我們在接受過大量治療的人群中觀察到了極其強大的療效。

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.

現在可以肯定地說，其中 40% 的患者 CAR-T 治療失敗，但其中 60% 的患者並未 CAR-T 治療失敗。因此，我們的期望、我們的意圖，正如我們之前在湯姆的準備好的演講中提到的那樣，我們預計將在下半年申請加速批准。

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.

我認為，您可以期待的是，我們相信，由於整體數據的可靠性，總人口，總復發/難治性人口，無論他們是否接受 CAR-T 治療失敗，都應該能夠使用 epcoritamab。

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.

在未來定位方面，我們過去也討論過我們啟動多階段的意圖——額外的 III 期，DLBCL 應用的確認性研究，III 期研究正在進行中。 這是復發/難治的情況。我們預計，我們將在未來 12 到 18 個月內啟動針對 DLBCL 和其他適應症的多個額外 III 期研究。

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，我是傑夫。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可以在社區中心治療。因此，從我們目前的研究中至少在高層聽到的是，哇，即使在 CAR-T 之後，其療效仍然令人印象深刻。

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.

但他們去的地方是，這種簡單的 epcoritamab 皮下注射可能是向我正在治療的患者輸送 T 細胞的最快方法。因此，根據 Neil 的觀點，這些數據看起來並不像是針對該藥物的。 事實上，它看起來似乎有助於人們認識到這是一種治療淋巴瘤的民主化藥物。因此，我們與醫師合作的初步工作非常令人鼓舞。

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

謝謝，克里斯。接線員，我們還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，感謝您在今天的電話會議中提供的所有詳細資訊。里克，我希望你能幫助我們了解當前的併購形勢，你能如何概括地描述它？然後，如果您能就 AbbVie 的交易機會更具體地發表評論。

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.

如果你看一下併購環境，你會發現許多參與者都在試圖擴大自己的投資組合。我認為目前整個產業對於大額交易的興趣普遍較低。

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.

其中部分原因可能是，美國聯邦貿易委員會 (FTC) 對大型交易以及您通過這些交易的能力的措辭一直非常嚴厲。我認為這與我們有關，我的意思是，我們將繼續執行在 Allergan 交易後製定的策略。

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.

艾爾建顯然為我們帶來了巨大的多樣性。那次交易非常成功，確實改變了 AbbVie 的外觀和形態，明顯提高了我們的業績，我們做得相當好。

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機會在我們認為有機會引入策略資產的領域中充實我們的投資組合。我們可能會更致力於早期資產的開發以擴充我們的研發管道。 Epcoritamab 是我們一直在尋找和發現的可以補充整體產品線的一個很好的例子，我認為這個策略非常有效，我們也將繼續推行這個策略。謝謝。

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，請造訪我們的網站 investor.abbvie.com。再次感謝您的加入。

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

謝謝你。通話就此結束。您可以斷開您的線路，感謝您的參與。