艾伯維 (ABBV) 2020 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good morning, and thank you for standing by. Welcome to the AbbVie Second Quarter 2020 Earnings Conference Call. (Operator Instructions) I would now like to introduce Ms. Liz Shea, Vice President of Investor Relations.

    早安,感謝您的支持。歡迎參加 AbbVie 2020 年第二季財報電話會議。 (操作員指示)現在,我想介紹投資者關係副總裁 Liz Shea 女士。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Good morning, and thanks for joining us. Also on the call with me today are: Rick Gonzalez, Chairman of the Board and Chief Executive Officer; Michael Severino, Vice Chairman and President; and Rob Michael, Executive Vice President and Chief Financial Officer. Joining us for the Q&A portion of the call is Laura Schumacher, Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary.

    早安,感謝您加入我們。今天與我一起參加電話會議的還有:董事會主席兼執行長 Rick Gonzalez;邁克爾·塞維裡諾(Michael Severino),副董事長兼總裁;以及執行副總裁兼財務長 Rob Michael。參與本次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勞拉‧舒馬赫 (Laura Schumacher)。

  • Before we get started, I remind you that some statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act 1995. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results 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 2019 annual report on Form 10-K and in our other SEC filings. AbbVie undertakes no obligation to update these forward-looking statements except as required by law.

    在我們開始之前,我提醒您,我們今天做出的一些聲明可能被視為《1995 年私人證券訴訟改革法案》規定的前瞻性聲明。有關這些風險和不確定性的更多資訊包含在我們的 2019 年 10-K 表年度報告和我們的其他 SEC 文件中。除法律要求外,AbbVie 不承擔更新這些前瞻性聲明的義務。

  • On today's conference call, as in the past, non-GAAP financial measures will be used to help investors understand AbbVie's ongoing business performance. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in our earnings release and regulatory filings from today which can be found on our website. Please note that the second quarter financial results and guidance provided on today's call for sales, EPS and line items of the P&L reflect a full period of legacy AbbVie operations and a partial year of contribution from the Allergan portfolio since the transaction closed in early May of this year.

    在今天的電話會議上,與過去一樣,將採用非 GAAP 財務指標來幫助投資者了解 AbbVie 的持續業務表現。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相協調,可在我們的網站上找到。請注意,今天的銷售電話會議上提供的第二季度財務業績和指引、每股收益和損益表項目反映了自今年 5 月初交易完成以來 AbbVie 傳統運營的整個時期以及 Allergan 產品組合的部分年度貢獻。

  • In addition, we have provided a quarterly comparable historical trend analysis for key product revenues of the newly combined company as a supplemental table in our earnings release this quarter. This table supports the comparison of sales growth on a comparable operational basis, including full quarter, current year and historical results for Allergan on a pro forma basis. Comparable operational percent changes are presented at a constant -- at constant currency rate. For this comparison of underlying performance, all historically reported Allergan revenues have been recast informed to conform to AbbVie's revenue recognition accounting policies and exclude the recent divestitures of ZENPEP and VIOKACE.

    此外,我們在本季度的收益報告中提供了新合併公司主要產品收入的季度可比較歷史趨勢分析作為補充表格。此表支援在可比較營運基礎上比較銷售成長情況,包括艾爾建的整個季度、當年和歷史業績(以預測為基礎)。可比營運百分比變化以恆定匯率表示。為了對基礎績效進行比較,所有歷史報告的 Allergan 收入均已重新調整,以符合 AbbVie 的收入確認會計政策,並排除最近對 ZENPEP 和 VIOKACE 的資產剝離。

  • Following our prepared remarks, we'll take your questions. So with that, I will now turn the call over to Rick.

    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。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Thank you, Liz. Good morning, everyone, and thank you for joining us. Today, I'll discuss our second quarter performance and highlights. And for the first time, I'll provide our 2020 outlook for the newly combined company. Mike will then discuss recent advancements across R&D programs. And Rob will review the quarter and our updated guidance in more detail. Following our remarks, we'll take your questions.

    謝謝你,莉茲。大家早安,感謝大家的收看。今天,我將討論我們第二季的業績和亮點。我將首次為新合併後的公司提供 2020 年的展望。然後,麥克將討論研發項目的最新進展。 Rob 將更詳細地回顧本季和我們更新的指引。在我們發言之後,我們將回答您的問題。

  • I'd like to start off by recognizing all of our employees, including those joining AbbVie from Allergan, for all of their hard work and dedication during this pandemic. The AbbVie team has been working diligently and carefully within our facilities and remotely to ensure that our business continues to operate properly and our patients continue to receive their medicines.

    首先,我要感謝我們所有的員工,包括從艾爾建加入艾伯維的員工,感謝他們在這次疫情期間的辛勤工作和奉獻精神。 AbbVie 團隊一直在我們的設施內和遠端勤奮、謹慎地工作,以確保我們的業務繼續正常運作並且我們的患者繼續收到他們的藥品。

  • Before I speak to the strong financial performance this quarter, I'd like to characterize the state of the recovery of the business from the COVID crisis. Let me start with the legacy AbbVie side of the business, which has demonstrated robust performance leading into the pandemic and has remained resilient. The impact on continuing patients for HUMIRA and new patients for RINVOQ, SKYRIZI and VENCLEXTA were not as pronounced as we had previously anticipated. While patient flow has not recovered in most therapeutic segments, we're encouraged by the level of stabilization and the recent positive demand trends.

    在談到本季強勁的財務表現之前,我想先描述一下業務從 COVID 危機中恢復的情況。讓我先從艾伯維 (AbbVie) 的傳統業務開始吧,該業務在疫情爆發前表現強勁,並且依然保持著韌性。對於 HUMIRA 的持續患者以及 RINVOQ、SKYRIZI 和 VENCLEXTA 的新患者的影響並不像我們之前預期的那麼明顯。儘管大多數治療領域的患者流量尚未恢復,但穩定水平和最近的積極需求趨勢令我們感到鼓舞。

  • Overall, the legacy AbbVie business continues to perform very well with stand-alone revenue growth in the second quarter of approximately 8.5% on an operational basis, excluding the negative impact from COVID. On the legacy Allergan side of the business, we saw significant COVID-related impacts on BOTOX Therapeutic and our aesthetics business in the second quarter. Both businesses are seeing a rapid recovery and are now performing near pre-COVID levels. Other key brands, such as VRAYLAR and UBRELVY, were impacted in a manner similar to the AbbVie-based business. And we're pleased with the recent trends and progress.

    總體而言,AbbVie 傳統業務持續表現良好,第二季獨立收入成長約 8.5%(不包括 COVID 帶來的負面影響)。在傳統的艾爾建業務方面,我們在第二季度看到 COVID 對 BOTOX 療程和我們的美容業務產生了重大影響。兩家公司業務均迅速復甦,目前業績已接近疫情前的水平。 VRAYLAR 和 UBRELVY 等其他主要品牌受到的影響與 AbbVie 業務類似。我們對最近的趨勢和進展感到滿意。

  • Overall, COVID had a substantial impact on second quarter reported revenues with an estimated net unfavorable impact of more than $900 million. However, by the end of June, the total business had recovered to more than 90% of pre-COVID levels. So I'm pleased with the resilience and the rapid recovery across our portfolio. And I'm confident in the continued strong underlying demand and performance of the combined new company.

    總體而言,COVID 對第二季報告的收入產生了重大影響,估計淨不利影響超過 9 億美元。然而,截至 6 月底,整體業務已恢復至疫情前的 90% 以上。因此,我對我們的投資組合的彈性和快速復甦感到滿意。我對合併後的新公司持續強勁的潛在需求和業績充滿信心。

  • Despite the impact from COVID, we delivered a strong second quarter performance. Adjusted earnings per share of $2.34 were well above our expectations. The $0.21 beat included $0.11 of net accretion from Allergan as well as $0.10 of favorable performance versus the midpoint of our stand-alone guidance. Total revenues were $10.4 billion, including approximately $8.4 billion of legacy AbbVie sales, significantly above our expectations for the standalone portfolio, with continued robust performance in both hem/onc and immunology despite the impact from COVID.

    儘管受到新冠疫情的影響,我們第二季的業績仍然強勁。調整後每股收益為 2.34 美元,遠高於我們的預期。超出預期 0.21 美元的收益包括來自 Allergan 的 0.11 美元淨增值以及與我們獨立指引中點相比高出 0.10 美元的業績。總收入為 104 億美元,其中包括約 84 億美元的傳統 AbbVie 銷售額,大大高於我們對獨立產品組合的預期,儘管受到 COVID 的影響,但在血液/腫瘤和免疫學方面仍保持強勁表現。

  • Hem/onc revenues of approximately $1.6 billion were up strong double digits again this quarter. IMBRUVICA sales grew approximately 17% on an operational basis, reflecting continued strong performance in CLL, where we remain the clear market leader. VENCLEXTA sales were up more than 80% on an operational basis with strong growth in CLL and AML. During the quarter, we also announced a strategic collaboration with Genmab to further build our oncology portfolio with a CD3xCD20 bispecific antibody. It has the potential to be a best-in-class therapy across B-cell malignancies.

    本季血液學/腫瘤學收入約為 16 億美元,再次實現強勁的兩位數成長。 IMBRUVICA 的銷售額在營運基礎上成長了約 17%,反映了我們在 CLL 領域的持續強勁表現,我們仍然是該領域的明顯市場領導者。 VENCLEXTA 的營業銷售額成長了 80% 以上,CLL 和 AML 的成長十分強勁。本季度,我們也宣布與 Genmab 建立策略合作,以 CD3xCD20 雙特異性抗體進一步建構我們的腫瘤學產品組合。它有可能成為治療 B 細胞惡性腫瘤的最佳療法。

  • Our leading immunology business delivered revenues of more than $5.3 billion, reflecting growth of more than 8.5% on an operational basis. U.S. HUMIRA revenue growth remained strong, up 5% with continued demand from the large installed patient base, partially offset by the impact of COVID-19. International HUMIRA biosimilar dynamics in the quarter were better than our expectations.

    我們領先的免疫學業務實現了超過 53 億美元的收入,營運成長率超過 8.5%。美國 HUMIRA 營收成長保持強勁,成長 5%,得益於大量已安裝患者群體的持續需求,但部分抵消了 COVID-19 的影響。本季國際HUMIRA生物相似藥動態優於我們的預期。

  • SKYRIZI continues to perform well and has maintained its leading in-play psoriasis patient share, which includes both new and switching patients at more than 30%. As expected, we saw modest delays to new patient starts during the quarter as a result of the COVID-19 dynamics. However, recent prescription trends and increasing enrollment in our ambassador program, 2 leading indicators, demonstrate a strong growth trajectory and support our full year guidance of $1.4 billion.

    SKYRIZI 繼續表現良好,並保持了領先的銀屑病患者份額,其中包括超過 30% 的新患者和轉治患者。如預期,由於 COVID-19 疫情的影響,本季新患者就診時間略有延遲。然而,最近的處方趨勢和我們大使計畫的不斷增加這兩個領先指標顯示出強勁的成長軌跡並支持我們全年 14 億美元的指導目標。

  • We're also seeing very encouraging trends for RINVOQ, where rheumatology office visits are approaching pre-COVID levels. RINVOQ revenues were up more than 70% on a sequential basis and currently reflect 15% in-play RA patient share, which is now nearly at parity to HUMIRA, the market leader in, in-play share and above all other agents in the segment. We're also making excellent progress with our immunology pipeline, which Mike will discuss further momentarily.

    我們也看到 RINVOQ 的趨勢非常令人鼓舞,風濕病科就診量已接近新冠疫情之前的水平。 RINVOQ 的收入環比增長超過 70%,目前反映了 15% 的 RA 患者份額,現在幾乎與 HUMIRA 持平,HUMIRA 是市場領導者,其份額高於該領域的所有其他藥物。我們的免疫學管道也取得了巨大進展,Mike 稍後將進一步討論。

  • As I noted during the quarter, we successfully completed the acquisition of Allergan, creating a stronger and a more diverse AbbVie. The transaction significantly expands and diversifies AbbVie's revenue base and complements our existing leadership positions in immunology and hematological oncology with additional growth franchises in aesthetics and neuroscience. We have growth opportunities in neuroscience with BOTOX Therapeutics, VRAYLAR and UBRELVY. And we have the leading global aesthetics business with flagship brands, including BOTOX Cosmetics and JUVÉDERM.

    正如我在本季所指出的,我們成功完成了對 Allergan 的收購,從而創造了更強大、更多元化的 AbbVie。這項交易大大擴展並多樣化了 AbbVie 的收入基礎,並透過美學和神經科學領域的額外成長特許經營補充了我們在免疫學和血液腫瘤學領域的現有領導地位。憑藉 BOTOX Therapeutics、VRAYLAR 和 UBRELVY,我們在神經科學領域擁有成長機會。我們擁有全球領先的美容業務,其旗艦品牌包括 BOTOX Cosmetics 和 JUVÉDERM。

  • I'll start with neuroscience, which had sales of roughly $735 million to AbbVie in the second quarter. VRAYLAR continues to demonstrate rapid growth and is well on its way to surpassing $1 billion in annual revenues. Underlying demand has remained resilient despite the COVID-19 pandemic with strong double-digit growth again this quarter. We see significant room for continued expansion within VRAYLAR's existing indications, bipolar disorder and schizophrenia. Major depressive disorder, or MDD, represents another potential large indication with 2 Phase III trials well underway.

    我先從神經科學開始,該領域在第二​​季度為 AbbVie 帶來了約 7.35 億美元的銷售額。 VRAYLAR 持續保持快速成長勢頭,年收入可望突破 10 億美元。儘管出現了新冠疫情,但基本需求依然保持彈性,本季再次實現強勁的兩位數成長。我們認為 VRAYLAR 在現有適應症(躁鬱症和精神分裂症)方面還有很大的持續擴展空間。重度憂鬱症(MDD)是另一種潛在的重大適應症,目前有兩項 III 期試驗正在進行中。

  • Also within neuroscience, we now have a portfolio of migraine therapies that have the potential to support long-term growth in a highly attractive and underserved market. Our migraine portfolio is anchored with BOTOX Therapeutic, which had revenues of roughly $300 million to AbbVie in the second quarter. Despite multiple new competitive entrants, BOTOX Therapeutic has largely retained its total treated patient base, a testament to its efficacy, safety and brand recognition. Like many physician-administered products, BOTOX Therapeutics saw a significant impact from COVID-19 in the second quarter with global sales down approximately 20% on a comparable operational basis. However, we're pleased by the recent data trends, which demonstrate a fast recovery and performance is now close to pre-COVID levels.

    此外,在神經科學領域,我們現在擁有一系列偏頭痛治療方法,這些方法有潛力支持這個極具吸引力且服務不足的市場的長期成長。我們的偏頭痛產品組合以 BOTOX Therapeutic 為基礎,該公司第二季為 AbbVie 帶來了約 3 億美元的收入。儘管有多個新的競爭對手進入,BOTOX Therapeutic 基本上保留了其總治療患者群,證明了其有效性、安全性和品牌認知度。與許多由醫生管理的產品一樣,BOTOX Therapeutics 在第二季度受到了 COVID-19 的重大影響,全球銷售額在可比營運基礎上下降了約 20%。然而,我們對最近的數據趨勢感到滿意,這表明復甦速度很快,而且業績目前接近疫情之前的水平。

  • The launch of UBRELVY, the first-to-market in leading oral CGRP for acute migraine is off to an excellent start. Feedback from physicians has been very positive, given UBRELVY's efficacy, safety and convenient dosing profile relative to current standards of care. Commercial access for UBRELVY is now at 70%, which along with increased consumer promotion, will further support the product's launch trajectory. We're also developing atogepant for the prevention of episodic and chronic migraine. We recently disclosed positive top line results from a Phase III study in episodic migraine, which will support regulatory submission early next year.

    UBRELVY 是首個上市用於治療急性偏頭痛的領先口服 CGRP 藥物,其上市取得了良好的開端。鑑於 UBRELVY 的有效性、安全性以及相對於現行治療標準的便捷劑量特性,醫生的回饋非常積極。 UBRELVY 的商業覆蓋率目前已達到 70%,再加上消費者推廣的加強,將進一步支持該產品的推出軌跡。我們也正在開發用於預防發作性和慢性偏頭痛的 atogepant。我們最近披露了發作性偏頭痛 III 期研究的積極頂線結果,這將支持明年初的監管提交。

  • As a fourth pillar of growth, we now have the world's leading global aesthetics franchise, which generated sales of roughly $480 million to AbbVie in second quarter. As anticipated, we saw a decline in year-over-year comparable operational growth with aesthetics health care providers closed during the initial phase of COVID. It's now been roughly 2 months since most major geographies have begun to reopen. And we're pleased with the strong recovery trends we're seeing. As of the end of June, the vast majority of our aesthetics accounts have reopened in the U.S. and we're seeing considerable pent-up demand.

    作為第四大成長支柱,我們現在擁有世界領先的全球美學特許經營權,該特許經營權在第二季度為 AbbVie 創造了約 4.8 億美元的銷售額。正如預期的那樣,由於在 COVID 初期美容保健提供者關閉,我們看到年比可比營運成長下降。目前,大多數主要地區已開始重新開放約 2 個月。我們對所看到的強勁復甦趨勢感到非常高興。截至 6 月底,我們絕大多數的美學帳戶已經在美國重新開放,我們看到了相當大的被壓抑的需求。

  • Current U.S. aesthetic revenues have recovered and are approaching 95% of pre-COVID levels. Outside the U.S., we're also seeing steady recovery trends in China and Western Europe. Current international aesthetics revenues have recovered to approximately 90% of pre-COVID levels. Overall, we're very pleased with the momentum we're seeing on our aesthetics franchise. More broadly, we see aesthetics as a durable cash pay business with an opportunity for significant market growth as well as continued new innovation driving long-term performance.

    目前美國美容收入已恢復,接近疫情前水準的95%。在美國以外,我們也看到中國和西歐呈現穩定復甦的趨勢。目前國際美容收入已恢復至疫情前水準的約90%。總的來說,我們對美學特許經營的發展勢頭感到非常滿意。更廣泛地說,我們認為美學是一項持久的現金支付業務,具有顯著的市場成長機會以及持續的創新推動長期業績。

  • While strategically important, the acquisition of Allergan will also drive strong financial benefits. Integration has been relatively seamless, and we're impressed by the caliber of talent that we've welcomed into AbbVie. We remain on track with our synergy target of more than $2 billion in expense rationalization by the third year from transaction closing, which Rob will discuss further in his prepared remarks here momentarily. When you take these synergies into consideration, along with the continued P&L leverage from our expected sales growth, we expect further operating margin expansion over the next couple of years.

    收購艾爾建不僅具有戰略重要性,還將帶來強勁的財務效益。整合過程相對順利,AbbVie 所吸收的人才水準給我們留下了深刻的印象。我們仍有望實現協同效應目標,即在交易結束後的第三年實現超過 20 億美元的費用合理化,Rob 稍後將在準備好的發言中進一步討論這一點。考慮到這些綜效,再加上預期銷售成長帶來的持續損益槓桿,我們預期未來幾年營業利潤率將進一步擴大。

  • While the COVID crisis remains a fluid situation, our business continues to remain resilient and demonstrate strong underlying growth. Although we continue to carefully watch COVID-related events in the U.S., we're pleased with our recent business trends and the progress we're making towards recovery. And we expect performance will continue to ramp to normalized levels over the course of the second half of 2020.

    儘管新冠疫情危機情勢依然不明朗,但我們的業務依然保持韌性並展現出強勁的潛在成長。儘管我們繼續密切關注美國的新冠疫情相關事件,但我們對近期的業務趨勢和復甦進展感到滿意。我們預計,2020 年下半年業績將繼續回升至正常水準。

  • With these current assumptions and based on our recent outperformance of our base business, today, we're issuing full year 2020 adjusted earnings per share guidance for our new combined company of $10.35 to $10.45, reflecting growth of 16.3% at the midpoint. This guidance assumes $0.70 of net accretion from the Allergan transaction in 2020, which represents 11% accretion on an annualized basis, ahead of our initial projections for the transaction, despite the COVID impact that I outlined earlier.

    根據這些當前假設以及我們近期基礎業務的優異表現,今天,我們發布了合併後新公司的 2020 年全年調整後每股收益指引,即 10.35 美元至 10.45 美元,中間值增長率為 16.3%。該指引假設 2020 年 Allergan 交易的淨增值為 0.70 美元,按年率計算為 11% 的增值,儘管受到我之前概述的 COVID 的影響,但仍高於我們對該交易的初步預測。

  • Overall, we continue to see good momentum across our total portfolio and across our pipeline. We reported a very strong second quarter performance and remain encouraged by the recent recovery trends, which are faster than we expected. We continue to expect the COVID pandemic will have a transient impact on our business with further recovery continuing through the second half of 2020. With the closing of the Allergan transaction, AbbVie is well positioned for enhanced long-term growth potential, a growing dividend, rapid debt repayment and strong investment in innovation across our therapeutic categories.

    總體而言,我們的整個投資組合和整個產品線繼續保持良好的發展勢頭。我們報告了第二季的強勁業績,並且對近期的復甦趨勢感到鼓舞,復甦速度快於我們的預期。我們仍然預計,COVID 疫情將對我們的業務產生短暫影響,​​並將持續進一步復甦至 2020 年下半年。

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

    說完這些,我將把電話轉給麥克。麥克風?

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • Thank you, Rick. We had a very productive quarter with continued progress across all stages of our pipeline. Additionally, with the recent closing of the Allergan acquisition, we added promising pipeline assets in the areas of aesthetics and neuroscience. We look forward to sharing updates as those programs progress through development.

    謝謝你,里克。我們度過了一個非常有成效的季度,我們的產品線各個階段都繼續取得進展。此外,隨著最近完成對 Allergan 的收購,我們在美學和神經科學領域增加了有前景的資產。我們期待在這些專案開發過程中分享更新資訊。

  • In immunology, we continue to advance our programs for RINVOQ and SKYRIZI in several new disease areas. This year, we intend to submit regulatory applications for 3 additional indications for RINVOQ. In June, we submitted applications for RINVOQ in psoriatic arthritis. We expect to file applications for atopic dermatitis and ankylosing spondylitis later this year.

    在免疫學方面,我們繼續在幾個新的疾病領域推進 RINVOQ 和 SKYRIZI 的計畫。今年,我們打算為 RINVOQ 提交另外 3 種適應症的監管申請。 6月份,我們提交了RINVOQ治療乾癬性關節炎的申請。我們預計將於今年稍後提交針對異位性皮膚炎和僵直性脊椎炎的申請。

  • We also recently reported top line results from our 3 registrational trials for RINVOQ in atopic dermatitis. 2 of these Phase III studies, Measure Up 1 and Measure Up 2, evaluated RINVOQ as a monotherapy for the treatment of adolescent and adult subjects with moderate to severe atopic dermatitis for candidates for systemic therapy. In the Measure Up 1 and Measure Up 2 studies, both doses of RINVOQ met all primary and secondary endpoints, demonstrating significant improvement in skin clearance and itch compared to placebo.

    我們最近也報告了 RINVOQ 治療異位性皮膚炎的 3 項註冊試驗的首要結果。其中兩項 III 期研究(Measure Up 1 和 Measure Up 2)評估了 RINVOQ 作為單一療法治療適合全身治療的中度至重度異位性皮膚炎青少年和成年受試者的療效。在 Measure Up 1 和 Measure Up 2 研究中,兩種劑量的 RINVOQ 均達到了所有主要和次要終點,與安慰劑相比,皮膚清除和瘙癢有顯著改善。

  • In Measure Up 1, roughly 70% of patients receiving the 15-milligram dose and 80% of patients on the 30-milligram dose achieved a 75% or greater improvement in skin lesions by week 16. We saw a similar rates of skin clearance in the Measure Up 2 study with roughly 60% of patients receiving the low dose and 73% of patients on the high dose, achieving a 75% or greater improvement by week 16. We also saw very rapid responses in these studies with clinically meaningful reductions in itch observed as early as 1 day after the first dose in patients receiving 30 milligrams and 2 days after the first dose in patients receiving 15 milligrams in both studies.

    在 Measure Up 1 中,大約 70% 的 15 毫克劑量患者和 80% 的 30 毫克劑量患者在第 16 週時皮膚病變改善了 75% 或更多。 ,在兩項研究中,接受 30 毫克的患者在第一次服用後 1 天就觀察到了臨床意義上的瘙癢減少,接受 15 毫克的患者在第一次服用後 2 天就觀察到了臨床意義上的瘙癢減少。

  • We also saw very strong results in our third registrational trial, the AD Up study, which evaluated RINVOQ in combination with topical corticosteroids. Similar to the results from the 2 Measure Up trials, RINVOQ met all primary and secondary endpoints in the AD Up study with patients who received RINVOQ showing significant improvements in skin clearance and reduction in itch compared to patients receiving placebo plus topical steroids following 16 weeks of treatment. Treatment with RINVOQ also led to a significant increase in the number of steroid-free days. And more patients receiving RINVOQ were able to stop topical corticosteroids altogether.

    我們也在第三次註冊試驗 AD Up 研究中看到了非常強勁的結果,該研究評估了 RINVOQ 與局部皮質類固醇的聯合使用。與 2 Measure Up 試驗的結果相似,RINVOQ 達到了 AD Up 研究中的所有主要和次要終點,經過 16 週的治療,與接受安慰劑加外用類固醇治療的患者相比,接受 RINVOQ 治療的患者皮膚清除情況顯著改善,瘙癢減少。 RINVOQ 治療還可顯著增加不使用類固醇的天數。更多接受 RINVOQ 治療的患者能夠完全停止使用外用皮質類固醇。

  • We're very encouraged by both the level of efficacy and the safety profile we've seen across all 3 Phase III atopic dermatitis studies. And we remain very confident that RINVOQ has the potential to provide a strong benefit-risk profile in moderate to severe atopic dermatitis. In addition to these 3 registrational studies, we are also evaluating RINVOQ in a head-to-head Phase III trial against dupilumab and expect to see data from this study later this year. In the area of inflammatory bowel disease, our Phase III program for RINVOQ in ulcerative colitis is progressing ahead of schedule. And we now expect to see top line data from the first Phase III induction study later this year.

    我們對全部 3 個 III 期異位性皮膚炎研究中看到的療效和安全性水準感到非常鼓舞。我們仍然非常有信心,RINVOQ 有可能在中度至重度異位性皮膚炎中提供強大的效益風險特徵。除了這 3 項註冊研究之外,我們還在對 RINVOQ 與 dupilumab 進行頭對頭 III 期試驗中對其進行評估,預計今年稍後會看到這項研究的數據。在發炎性腸道疾病領域,我們針對潰瘍性結腸炎的 RINVOQ 的 III 期計畫正在提前進展。我們預計今年稍後將看到第一階段 III 期誘導研究的頂線數據。

  • We also recently reported top line results from a proof-of-concept study, evaluating our novel TNF steroid conjugate, ABBV-3373 in RA. In this study, our goal is to drive a greater reduction in disease activity beyond the levels that can be achieved with HUMIRA or other high-efficacy agents, such as RINVOQ. To achieve adequate statistical power, we used preplanned historical HUMIRA data in combination with in-trial data when comparing ABBV-3373 to HUMIRA. The study used 2 analyses for the primary endpoint, which evaluated improvement from baseline in DAS28 score.

    我們最近也報告了概念驗證研究的頂線結果,該研究評估了我們的新型 TNF 類固醇結合物 ABBV-3373 在 RA 中的應用。在這項研究中,我們的目標是進一步降低疾病活動性,使其超越使用 HUMIRA 或其他高效藥物(如 RINVOQ)所能達到的水平。為了獲得足夠的統計能力,在比較 ABBV-3373 與 HUMIRA 時,我們使用了預先規劃的歷史 HUMIRA 資料與試驗資料。該研究對主要終點採用了 2 種分析,評估了 DAS28 評分相對於基線的改善。

  • The first analysis used a propensity matching strategy to compare 3373 with historical HUMIRA data. This analysis showed a greater change in DAS28 from baseline to week 12 for 3373 compared to the prespecified HUMIRA data. The second analysis used the Bayesian approach to compare 3373 to a combined in-trial and historical HUMIRA data set. And this analysis predicted with a 90% probability that 3373 was associated with a greater improvement in DAS28. Based on these encouraging results, we plan to advance the TNF steroid conjugate program in RA with a Phase IIb dose-ranging study expected to begin in the first half of 2021.

    第一個分析採用傾向配對策略將 3373 與歷史 HUMIRA 資料進行比較。分析顯示,與預先指定的 HUMIRA 數據相比,3373 的 DAS28 從基線到第 12 週發生了較大變化。第二項分析採用貝葉斯方法將 3373 與試驗中和歷史 HUMIRA 資料集進行比較。該分析以 90% 的機率預測 3373 與 DAS28 的更大改善相關。基於這些令人鼓舞的結果,我們計劃推進 RA 中的 TNF 類固醇結合物計劃,並預計於 2021 年上半年開始 IIb 期劑量範圍研究。

  • We also plan to begin clinical studies next year in other immune-mediated diseases. Also in the area of immunology, we're making good progress advancing the programs for SKYRIZI in new disease areas. We expect to see data from Phase III studies in psoriatic arthritis later this year and in Crohn's disease at the end of this year or early next year with regulatory submissions for both indications expected in 2021.

    我們也計劃明年開始針對其他免疫介導疾病的臨床研究。此外,在免疫學領域,我們在推進 SKYRIZI 在新疾病領域的計畫方面取得了良好進展。我們預計將在今年稍後看到銀屑病關節炎 III 期研究的數據,並在今年年底或明年初看到克羅恩病 III 期研究的數據,預計這兩種適應症的監管提交將於 2021 年完成。

  • In oncology, we continue to advance our hem/onc strategy with several important data readouts and study starts occurring this year. We've established a leading hem/onc portfolio with IMBRUVICA and VENCLEXTA in areas such as CLL and AML. And we will continue to generate data to demonstrate the utility of both drugs across a wide range of patient populations and cancer types.

    在腫瘤學領域,我們繼續推進我們的血液/腫瘤學策略,今年有幾項重要的數據讀數和研究開始進行。我們已透過 IMBRUVICA 和 VENCLEXTA 在 CLL 和 AML 等領域建立了領先的血液/腫瘤產品組合。我們將繼續產生數據來證明這兩種藥物對廣泛患者群體和癌症類型的效用。

  • At the recent EHA Congress, detailed results from the Phase III VIALE-A study were reported, which showed the treatment with a combination of VENCLEXTA plus azacitidine resulted in a 34% reduction in the risk of death compared to azacitidine plus placebo in AML patients, who are ineligible for intensive chemotherapy. The median overall survival for patients in the VENCLEXTA arm was 14.7 months versus 9.6 months in the placebo arm.

    在前不久召開的EHA大會上,報告了第三階段VIALE-A研究的詳細結果,結果顯示,對於不適合接受強化化療的AML患者,使用VENCLEXTA和阿扎胞苷聯合治療,與阿扎胞苷加安慰劑相比,可使死亡風險降低34%。 VENCLEXTA 組患者的中位總存活期為 14.7 個月,而安慰劑組患者的中位總存活期為 9.6 個月。

  • Patients in the VENCLEXTA arm also showed more than double the rate of composite complete remission compared to those treated with azacitidine alone. This filing is currently being reviewed by the FDA under the real-time oncology review program in Project Orbis. To date, the AML program has focused on VENCLEXTA's use as a frontline treatment in transplant-ineligible patients. This year, we are expanding the program into other patient segments with the goal of establishing VENCLEXTA as a gold standard across the AML patient spectrum.

    與單獨接受阿札胞苷治療的患者相比,VENCLEXTA 組患者的綜合完全緩解率也高出一倍以上。目前,FDA 正在根據 Project Orbis 中的即時腫瘤學審查計劃對該申請進行審查。到目前為止,AML 計畫一直專注於將 VENCLEXTA 用於不適合移植的患者的第一線治療。今年,我們將該計畫擴展到其他患者群體,目標是將 VENCLEXTA 確立為整個 AML 患者群體的黃金標準。

  • Earlier this year, we initiated 2 Phase III studies evaluating VENCLEXTA as a maintenance therapy in AML: one trial in fit patients with AML who have received stem cell transplant but remain at high-risk for relapse; and a second trial in patients with AML who are in first remission after receiving conventional induction and consolidation chemotherapies. In addition, building upon the survival advantage observed in the transplant-ineligible population, we are planning to initiate a new randomized study later this year testing VENCLEXTA in combination with intensive chemotherapy in patients who are eligible for more intensive induction regimens. Our comprehensive development program will position VENCLEXTA as a foundation for combination therapies in AML across all patient segments.

    今年早些時候,我們啟動了兩項 III 期研究,評估 VENCLEXTA 作為 AML 維持療法的效果:一項試驗針對的是已接受幹細胞移植但仍處於高復發風險的健康 AML 患者;第二項試驗針對的是接受常規誘導和鞏固化療後處於第一次緩解的 AML 患者。此外,基於在不適合移植的人群中觀察到的生存優勢,我們計劃在今年稍後啟動一項新的隨機研究,在適合接受更強化誘導方案的患者中測試 VENCLEXTA 與強化化療相結合的療效。我們的綜合開發計劃將使 VENCLEXTA 成為所有患者群體的 AML 聯合療法的基礎。

  • We also recently announced a broad oncology collaboration with Genmab to jointly develop and commercialize 3 next-generation bispecific antibody products and establish a discovery collaboration to create additional differentiated antibody-based therapeutics for cancer. The lead asset in this partnership, epcoritamab, a CD3xCD20 bispecific antibody, has demonstrated a strong efficacy profile, favorable safety and a more convenient dosing regimen in early phase trials. We believe epcoritamab has the potential to become a best-in-class therapy across a number of B-cell malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. And we are rapidly advancing it to Phase III trials.

    我們最近也宣布與 Genmab 進行廣泛的腫瘤學合作,共同開發和商業化 3 種下一代雙特異性抗體產品,並建立發現合作關係,以創造更多基於抗體的差異化癌症治療方法。此次合作的主要資產epcoritamab是一種CD3xCD20雙特異性抗體,在早期試驗中表現出了強大的療效、良好的安全性和更方便的給藥方案。我們相信 epcoritamab 有可能成為治療多種 B 細胞惡性腫瘤(包括瀰漫性大 B 細胞淋巴瘤和濾泡性淋巴瘤)的最佳治療方法。我們正在迅速推進其第三階段試驗。

  • And lastly, a few updates from other areas of our pipeline. We previously presented positive progression-free survival data from 2 Phase III studies for veliparib in frontline ovarian cancer and BRCA breast cancer. Based on developments in the field and additional discussions with the FDA, we will not be submitting regulatory applications without mature overall survival data. We will continue to follow patients in the ongoing trials as overall survival data mature.

    最後,我們來看看我們管道其他領域的一些更新。我們先前公佈了 2 項 III 期研究的 veliparib 在治療一線卵巢癌和 BRCA 乳癌方面的積極無惡化存活期數據。根據該領域的發展以及與 FDA 的進一步討論,我們不會在沒有成熟的整體生存數據的情況下提交監管申請。隨著整體生存數據的成熟,我們將繼續追蹤正在進行的試驗中的患者。

  • In eye care, we recently announced receipt of a complete response letter from the FDA for the abicipar BLA. The CRL indicated that the rate of intraocular inflammation observed in the Phase III program resulted in an unfavorable benefit-risk ratio. We are currently reviewing the abicipar program to determine next steps and will provide updates as they become available. In women's health, in the quarter, we received FDA approval of ORIAHNN as the first nonsurgical oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This new nonsurgical treatment represents an important therapeutic option for women suffering from uterine fibroids.

    在眼科護理方面,我們最近宣布收到了 FDA 關於 abicipar BLA 的完整回信。 CRL 表明,在 III 期計畫中觀察到的眼內發炎發生率導致不利的效益風險比。我們目前正在審查 abicipar 計劃以確定下一步行動,並將在可用時提供更新。在婦女健康方面,本季度,我們獲得 FDA 批准 ORIAHNN,作為首個用於治療停經前婦女子宮肌瘤相關月經過多出血的非手術口服治療方法。這種新的非手術治療方法為患有子宮肌瘤的女性提供了重要的治療選擇。

  • And in neuroscience, we recently reported top line results from a Phase III study evaluating atogepant for the prevention of episodic migraine. In this study, all 3 doses of atogepant met the primary endpoint, evaluating the change from baseline in mean monthly migraine days across the 12-week treatment period. The 2 higher doses, 30 milligrams and 60 milligrams, also met all secondary endpoints while the 10-milligram dose met 4 out of 6 of the secondaries. Allergan had previously reported positive results from one registration-enabling study. And following this second positive study, we plan to submit our regulatory applications in episodic migraine prevention in the first quarter of 2021.

    在神經科學領域,我們最近報告了評估 atogepant 預防發作性偏頭痛的 III 期研究的重要結果。在這項研究中,所有 3 種劑量的 atogepant 均達到了主要終點,評估了 12 週治療期間平均每月偏頭痛天數相對於基線的變化。兩個較高劑量(30 毫克和 60 毫克)也滿足了所有次要終點,而 10 毫克劑量滿足了 6 個次要終點中的 4 個。艾爾建先前曾報告了一項註冊研究的積極成果。在第二次積極研究之後,我們計劃在 2021 年第一季提交發作性偏頭痛預防的監管申請。

  • 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 2020. With that, I'll turn the call over to Rob for additional comments on our second quarter performance and financial outlook. Rob?

    總而言之,我們在上半年的各個階段都取得了巨大進展,並且我們仍有望在 2020 年剩餘時間內取得進一步進展。搶?

  • Robert A. Michael - Executive VP & CFO

    Robert A. Michael - Executive VP & CFO

  • Thank you, Mike. Starting with second quarter results. We delivered top and bottom line performance ahead of expectations. We reported adjusted earnings per share of $2.34, above our guidance midpoint by $0.21. This includes $0.10 of stronger performance from legacy AbbVie and $0.11 of accretion from Allergan. Total net revenues were $10.4 billion, including $2 billion in sales contribution from the Allergan portfolio. Legacy AbbVie was approximately $300 million ahead of our stand-alone sales guidance, driven by RINVOQ, SKYRIZI and HUMIRA. COVID-related inventory stocking for the first quarter largely reversed as expected.

    謝謝你,麥克。從第二季的業績開始。我們實現的營收和淨利潤均超乎預期。我們報告調整後每股收益為 2.34 美元,比我們的指導中位數高出 0.21 美元。這包括來自傳統 AbbVie 的 0.10 美元的強勁表現和來自 Allergan 的 0.11 美元的增值。總淨收入為 104 億美元,其中包括來自 Allergan 產品組合的 20 億美元銷售貢獻。在 RINVOQ、SKYRIZI 和 HUMIRA 的推動下,原 AbbVie 的銷售額比我們的獨立銷售預期高出約 3 億美元。第一季與疫情相關的庫存囤積基本上如預期逆轉。

  • U.S. HUMIRA sales were approximately $4 billion, ahead of expectations due to the lower impact from COVID on continuing patient prescriptions. Wholesaler inventory levels remained below 0.5 month in the quarter. International HUMIRA sales were $863 million, down 17.4% operationally, reflecting biosimilar competition across Europe and other international markets and ahead of our expectations.

    美國 HUMIRA 的銷售額約為 40 億美元,由於 COVID 對患者持續處方的影響較小,超出預期。本季批發商庫存水準仍低於 0.5 個月。 HUMIRA 的國際銷售額為 8.63 億美元,營運下降 17.4%,反映了歐洲和其他國際市場的生物相似藥競爭,並且超出了我們的預期。

  • SKYRIZI global sales were $330 million with continued strong U.S. in-play market share. We also continue to see robust demand for RINVOQ with sales of $149 million in the quarter and a rapid increase in U.S. in-play market share. Hematologic oncology global sales were nearly $1.6 billion, up 25.8% on an operational basis, with continued strong performance of both IMBRUVICA and VENCLEXTA.

    SKYRIZI 全球銷售額為 3.3 億美元,美國遊戲市場持續保持強勁成長。我們也繼續看到對 RINVOQ 的強勁需求,本季的銷售額為 1.49 億美元,美國遊戲市佔率迅速增加。血液腫瘤學全球銷售額接近 16 億美元,按營運基礎成長 25.8%,IMBRUVICA 和 VENCLEXTA 繼續表現強勁。

  • IMBRUVICA global net revenues were approximately $1.3 billion, up 17.2%, driven by continued strong performance in CLL. VENCLEXTA revenues were $303 million with strong demand across all approved indications. Global MAVYRET sales were $376 million, down 51.4% on an operational basis as treated patient volumes have declined during the COVID pandemic.

    IMBRUVICA 全球淨收入約為 13 億美元,成長 17.2%,這得益於 CLL 持續強勁的表現。 VENCLEXTA 的營收為 3.03 億美元,所有核准適應症的需求均強勁。由於 COVID 大流行期間治療的患者數量下降,MAVYRET 的全球銷售額為 3.76 億美元,按營運基礎計算下降 51.4%。

  • Allergan Aesthetics contributed sales of $481 million in the quarter. BOTOX Cosmetic with sales of $226 million and JUVÉDERM with sales of $113 million are both seeing a faster-than-expected recovery from the COVID pandemic. Neuroscience global revenues were $734 million. These results were led by BOTOX Therapeutic, VRAYLAR and UBRELVY with combined sales of more than $500 million. We also saw a significant contribution from our eye care business, which had global sales of $417 million.

    艾爾建美學公司本季貢獻了 4.81 億美元的銷售額。銷售額為 2.26 億美元的 BOTOX Cosmetic 和銷售額為 1.13 億美元的 JUVÉDERM 均從新冠疫情中實現了比預期更快的復甦。神經科學全球收入為 7.34 億美元。這些業績由 BOTOX Therapeutic、VRAYLAR 和 UBRELVY 領先,它們的總銷售額超過 5 億美元。我們的眼部護理業務也做出了重大貢獻,全球銷售額達 4.17 億美元。

  • Turning now to the P&L profile for the second quarter. Adjusted gross margin was 82.8% of sales, adjusted R&D investment was 12.8% of sales and adjusted SG&A expense was 22.9% of sales. The adjusted operating margin ratio was 47% of sales, including a negative impact of 70 basis points due to the reversal of COVID-related inventory stocking from the first quarter. Adjusted net interest expense was $484 million and the adjusted tax rate was 11.4%.

    現在來看看第二季的損益狀況。調整後的毛利率為銷售額的 82.8%,調整後的研發投入為銷售額的 12.8%,調整後的銷售、一般及行政費用為銷售額的 22.9%。調整後的營業利潤率為銷售額的 47%,其中包括因第一季與 COVID 相關的庫存備貨逆轉而產生的 70 個基點的負面影響。調整後淨利息支出為4.84億美元,調整後的稅率為11.4%。

  • Today, we are issuing combined company guidance for the first time. As Rick previously discussed, we are closely monitoring the impact of the COVID pandemic and have factored the latest trends into our updated forecast. We now expect full year adjusted earnings per share between $10.35 and $10.45, including $0.70 of accretion from the Allergan transaction, which represents an annualized contribution of 11%. Excluded from this guidance is $6.23 of known intangible amortization and specified items.

    今天,我們首次發布合併公司指引。正如 Rick 之前所討論的,我們正在密切關注 COVID 大流行的影響,並將最新趨勢納入我們更新的預測中。我們現在預計全年調整後每股收益將在 10.35 美元至 10.45 美元之間,其中包括 Allergan 交易的 0.70 美元增值,這相當於年化貢獻率為 11%。本指引不包括 6.23 美元的已知無形資產攤銷和指定項目。

  • This guidance now contemplates full year revenue of approximately $45.5 billion. At current rates, we now expect foreign exchange to have a 30 basis point unfavorable impact on full year reported sales growth. Included in this revenue guidance are the following updated full year assumptions.

    該指引目前預計全年營收約 455 億美元。以當前匯率計算,我們預計外匯將對全年報告銷售成長產生 30 個基點的不利影響。本收入指引包括以下更新的全年假設。

  • We now expect U.S. HUMIRA sales growth of approximately 8%. We now expect international HUMIRA sales of approximately $3.5 billion. For RINVOQ, we now expect global revenues of approximately $600 million. For global HCV, we now expect sales of approximately $2.1 billion as treatments remain below pre-COVID levels. For aesthetics, we expect global sales of approximately $2.4 billion, including approximately $1 billion from BOTOX Cosmetic and approximately $650 million from JUVÉDERM.

    我們現在預計美國HUMIRA的銷售額成長約為8%。我們現在預計 HUMIRA 的國際銷售額約為 35 億美元。對於 RINVOQ,我們現在預計全球營收約為 6 億美元。對於全球 HCV,由於治療費用仍低於 COVID 之前的水平,我們現在預計銷售額約為 21 億美元。在美容方面,我們預計全球銷售額約為 24 億美元,其中 BOTOX Cosmetic 銷售額約 10 億美元,JUVÉDERM 銷售額約 6.5 億美元。

  • For neuroscience, we expect global sales of approximately $3.5 billion, including approximately $1.4 billion from BOTOX Therapeutic and approximately $950 million from VRAYLAR. For eye care, we expect global revenues of approximately $2.1 billion, including approximately $700 million from RESTASIS, which assumes no generic competition in 2020. And for women's health, we expect global revenues of approximately $700 million. All other full year product guidance assumptions remain unchanged.

    對於神經科學方面,我們預計全球銷售額約為 35 億美元,其中 BOTOX Therapeutic 銷售額約 14 億美元,VRAYLAR 銷售額約 9.5 億美元。對於眼科護理,我們預計全球收入約為 21 億美元,其中包括來自 RESTASIS 的約 7 億美元,假設 2020 年沒有仿製藥競爭。所有其他全年產品指導假設保持不變。

  • Moving to the P&L. We now forecast adjusted gross margin just above 82% of sales, adjusted R&D investment to be approximately $5.8 billion, adjusted SG&A expense to be approximately $9.9 billion and adjusted operating margin of approximately 48% of sales. This P&L guidance includes approximately $600 million in expense synergies for the partial year in 2020. We remain on track to deliver greater than $2 billion in expense synergies by 2022. We now expect adjusted net interest expense of approximately $2 billion, which includes the cost of financing the Allergan transaction. We now model a non-GAAP tax rate of just above 11% for the newly combined company. Finally, we now expect our full year average share count to approach 1.7 billion shares, including the equity issue to finance the Allergan acquisition.

    轉到損益表。我們現在預測調整後的毛利率略高於銷售額的 82%,調整後的研發投資約為 58 億美元,調整後的銷售、一般及行政費用約為 99 億美元,調整後的營業利潤率約為銷售額的 48%。本損益指引包括 2020 年部分年度約 6 億美元的費用綜效。 我們仍有望在 2022 年前實現超過 20 億美元的費用綜效。我們現在為新合併後的公司製定了一個略高於 11% 的非 GAAP 稅率。最後,我們現在預計全年平均股數將接近 17 億股,其中包括為收購 Allergan 而發行的股票。

  • As we look ahead to the third quarter, we anticipate adjusted revenue of approximately $12.8 billion. At current rates, we expect foreign exchange to have a modest unfavorable impact on reported sales growth. We are forecasting an adjusted operating margin ratio of just above 48% of sales. We model a non-GAAP tax rate of 11.6% and we expect the average share count to approach 1.8 billion shares. We expect adjusted earnings per share between $2.73 and $2.77, excluding approximately $1.59 of known intangible amortization and specified items.

    展望第三季度,我們預計調整後營收約為 128 億美元。以當前匯率計算,我們預期外匯將對報告的銷售成長產生適度不利影響。我們預測調整後的營業利益率將略高於銷售額的48%。我們模擬的非公認會計準則稅率為 11.6%,預計平均股數將接近 18 億股。我們預計調整後的每股收益在 2.73 美元至 2.77 美元之間,不包括約 1.59 美元的已知無形資產攤銷和特定項目。

  • AbbVie remains well positioned to execute on our capital allocation priorities, including rapidly paying down debt, supporting a strong and growing dividend and pursuing additional innovative mid- to late-stage pipeline assets. We generated $6.9 billion of operating cash flow in the first half of the year. And our cash balance at the end of June was $6 billion. We are on track to pay down $15 billion to $18 billion of combined company debt by the end of 2021, of which nearly $7 billion has already been repaid. We expect to achieve a net debt-to-EBITDA ratio of 2.5x by the end of 2021 with further deleveraging through 2023.

    AbbVie 仍然處於有利地位,可以執行我們的資本配置重點,包括迅速償還債務、支持強勁且不斷增長的股息以及尋求更多創新的中後期管道資產。我們上半年創造了69億美元的營運現金流。六月底我們的現金餘額為 60 億美元。我們預計在 2021 年底前償還 150 億至 180 億美元的公司合併債務,其中近 70 億美元已經償還。我們預計到 2021 年底淨負債與 EBITDA 比率將達到 2.5 倍,到 2023 年將進一步去槓桿。

  • In closing, AbbVie's performance and financial condition remain strong. We are very pleased with the momentum of the business heading into the second half of 2020. With that, I'll turn the call back over to Liz.

    最後,AbbVie 的業績和財務狀況依然強勁。我們對 2020 年下半年業務的發展勢頭感到非常滿意。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Thanks, Rob. We will now open the call for questions. Operator, first question, please.

    謝謝,羅布。我們現在開始提問。接線員,請問第一個問題。

  • Operator

    Operator

  • (Operator Instructions) Our first question today is from Randall Stanicky from RBC Capital Markets.

    (操作員指示)我們今天的第一個問題來自 RBC Capital Markets 的 Randall Stanicky。

  • Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

    Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

  • I just have two, one for Rick and one for Rob. Rick, a bigger-picture question, a huge part of the AbbVie story is...

    我只有兩個,一個給 Rick,一個給 Rob。瑞克,一個更大層面的問題,艾伯維故事的很大一部分是...

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Randall, sorry to interrupt. We can't hear you very well. Is there any way you can turn up your mic or speak up?

    蘭德爾,抱歉打擾了。我們聽不清楚你的聲音。有什麼辦法可以調高麥克風音量或大聲說話嗎?

  • Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

    Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

  • Great. Is that better?

    偉大的。這樣好些了嗎?

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Yes.

    是的。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • It's okay.

    沒關係。

  • Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

    Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

  • Great. Rick, I wanted to ask, a big part of the AbbVie story is growth on the other side of HUMIRA in 2023. There's still some trepidation with -- from investors in getting comfortable with the step-down. What would you say to those investors to get people comfortable that there's a growth story on the other side of HUMIRA? And what do you need to do specifically between now and then strategically to position the business for that?

    偉大的。里克,我想問一下,艾伯維故事的很大一部分是 2023 年 HUMIRA 的另一面的增長。您想對那些投資人說些什麼,讓他們相信 HUMIRA 的另一面也有一個成長故事?那麼從現在到那時,您需要具體做些什麼來從策略上定位業務呢?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Okay. Randall, did you have a second question? Or is that...

    好的。蘭德爾,你還有第二個問題嗎?或者是...

  • Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

    Randall S. Stanicky - MD of Global Equity Research & Lead Analyst

  • Yes. The second question, I'll ask it upfront for Rob. Just if you could help us understand the steady state, the run rate for R&D. I think you said $5.8 billion for this year that will go higher on an annualized basis. But you're also pulling $1 billion of R&D synergies out of that as well.

    是的。第二個問題,我會提前為 Rob 詢問。如果您能幫助我們了解穩定狀態,即研發的運作率。我認為您說的是今年的 58 億美元,以年率計算還會更高。但您也從中獲得了 10 億美元的研發綜效。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Okay. I'll cover your first question, Randall, and then Rob can jump in and talk through the R&D funding question that you had. So look, I think it's a great question. It is one that, obviously, the vast majority of investors are interested in. We have described, I think, to investors the rationale of why we were excited about doing the Allergan transaction. It obviously gives us a tremendous amount of ability to be able to manage our way through the loss of exclusivity in the U.S. of HUMIRA. It provides us with 2 more major growth franchises for the company to help drive growth. And it allows us to continue to invest aggressively, both in internal R&D as well as external. And so I think it provides the framework to allow us to continue to perform as we have performed over the last number of years. I mean, clearly, we have -- we certainly have a track record of showing that we can grow this business and we can build on this business. We've demonstrated that since 2013, when we spun out.

    好的。蘭德爾,我將回答你的第一個問題,然後羅布可以加入討論你提出的研發資金問題。所以我認為這是一個很好的問題。顯然,絕大多數投資者都對此感興趣。顯然,這給了我們巨大的能力來應對 HUMIRA 在美國失去獨家經營權的問題。它為我們提供了另外兩個主要的成長特許經營權,以幫助推動公司成長。這使我們能夠繼續大力投資內部研發和外部研發。因此,我認為它提供了一個框架,使我們能夠繼續像過去幾年那樣表現。我的意思是,很明顯,我們確實有良好的記錄,證明我們可以發展這項業務,並且可以在此基礎上再接再厲。自 2013 年分拆以來,我們就已經證明了這一點。

  • So what makes me excited and what makes me comfortable that I can ultimately grow the business through the LOE? I think it starts with, look, we have 6 major growth assets in our business today if you step back and you look at them, 6 medicines that have tremendous opportunity to be able to grow: SKYRIZI, RINVOQ, IMBRUVICA, VENCLEXTA, VRAYLAR, UBRELVY. We'll probably have atogepant here in the not-too-distant future. So we'll have a seventh asset, all in markets that have a significant opportunity to be able to grow. When I look at our R&D productivity, both in the indication expansion area as well as new assets, and I'll talk about that here in a second, I'm very comfortable with our ability to be able to continue to drive the pipeline.

    那麼,是什麼讓我感到興奮和安心,相信我最終能夠透過 LOE 發展業務?我認為首先要看的是,如果退一步來看,我們今天的業務中有 6 項主要成長資產,這 6 種藥物具有巨大的成長機會:SKYRIZI、RINVOQ、IMBRUVICA、VENCLEXTA、VRAYLAR 和 UBRELVY。在不久的將來,我們可能會在這裡擁有一個。因此,我們將擁有第七種資產,所有這些資產都位於具有巨大成長機會的市場中。當我審視我們的研發生產力時,無論是在適應症擴展領域還是在新資產方面,我稍後會談到這一點,我對我們能夠繼續推動管道發展的能力感到非常滿意。

  • When you look at the projections that we made for RINVOQ and SKYRIZI as an example, when we made those projections a year or 2 ago, those peak projections for 2025, we based those projections on the fact that those assets had to achieve roughly high single-digit market share positions. As we mentioned, right now, if you look at SKYRIZI, it's achieving in-play share of 30%. RINVOQ has really stood up and rapidly started to capture share. It's at 15% and growing at a very aggressive clip. I would predict that it will quickly become the in-play market leader above HUMIRA here in the not-too-distant future. But they're already significantly above what those estimates were. The longer you stay at in-play shares that look like that, obviously the greater you're going to exceed that. If you get to 20% instead of high single digits, obviously the revenue will be approximately 2x what we had originally projected. So that gives me a high level of comfort.

    以我們對 RINVOQ 和 SKYRIZI 所做的預測為例,當我們在一兩年前做出這些預測時,那些對 2025 年的峰值預測,是基於這些資產必須實現大約個位數的高市場份額地位這一事實而做出的。正如我們所提到的,現在,如果你看看 SKYRIZI,它的遊戲份額已經達到了 30%。 RINVOQ 確實站起來了,並開始迅速佔領市場份額。其成長率為 15%,且速度非常快。我預測,在不久的將來,它將迅速成為超越 HUMIRA 的遊戲市場領導者。但它們的數量已經遠高於預期。您在這種遊戲中停留的時間越長,顯然您超出該範圍的幅度就越大。如果達到 20% 而不是高個位數,顯然收入將是我們最初預期的 2 倍左右。這讓我感到非常舒服。

  • When I look at VENCLEXTA, as an example, there's still a significant opportunity to grow there. If we get an indication expansion, both broadening AML as well as the t(11;14) in multiple myeloma, those are 2 significant opportunities that we'll continue to be able to drive growth. IMBRUVICA still has significant opportunity to be able to drive growth. When I look at VRAYLAR, as an example, that's a very interesting asset, has a great profile in that market, the drug does. It's obviously growing significantly. I mean it's been growing now at the rate of about 80% to 90% year-over-year. There's still plenty of room to grow in bipolar and schizophrenia. And if 1 of those 2 Phase III studies plays out effectively, MDD will be a very large additional indication, which will allow us to be able to drive significant growth there.

    以 VENCLEXTA 為例,我發現它仍有很大的發展機會。如果我們獲得適應症擴展,包括擴大 AML 以及多發性骨髓瘤中的 t(11;14),那麼這兩個重要的機會將使我們能繼續推動成長。 IMBRUVICA 仍然具有巨大的推動成長的機會。以 VRAYLAR 為例,我發現它是一項非常有趣的資產,在該市場上享有很高的聲譽,而這種藥物確實如此。顯然,它正在大幅增長。我的意思是現在它的成長率約為每年 80% 到 90%。雙極性情感障礙和精神分裂症的治療仍有很大的發展空間。如果這兩項 III 期研究中的一項有效進行,MDD 將是一個非常大的附加適應症,這將使我們能夠在該領域實現顯著成長。

  • And then there's the migraine franchise. I think migraine is something that's underappreciated. If you look at the penetration right now of oral agents in the acute area, it's running about 12% to 14% of total scripts. So obviously, there's a significant opportunity to be able to continue to expand that market. We think we have the asset to be able to do that. And obviously, we think we have the promotional ability to do it. So I think we have the tools right now to be able to drive significant growth through the LOE.

    然後還有偏頭痛。我認為偏頭痛是一種尚未被充分重視的疾病。如果你看看目前口服藥物在急性病領域的滲透率,它約佔總處方量的 12% 至 14%。因此顯然,這是一個繼續擴大該市場的巨大機會。我們認為我們有能力做到這一點。顯然,我們認為我們有能力做到這一點。因此我認為我們現在擁有透過 LOE 推動顯著成長的工具。

  • On the other side of the LOE, obviously, our pipeline will continue to play out with the additional indications. You're starting to see assets like our TNF steroid. Of all, I think the Genmab collaboration is an important collaboration to continue to build out. Our hem/onc can potentially sell 2 more platforms. And so there's a lot of exciting opportunities. So I feel very confident in, one, how the business is running now despite all of the disruption associated with COVID. But I look at the part of the business that we control directly, I feel very good about how the business is running. And so I believe we will navigate our way through it. And I think as we get a little closer, investors will gain an even greater appreciation of that.

    在 LOE 的另一端,顯然我們的管道將繼續發揮額外的指示作用。您開始看到像我們的 TNF 類固醇這樣的資產。總而言之,我認為 Genmab 合作是一項值得繼續前進的重要合作。我們的 hem/onc 有可能再銷售 2 個平台。因此,存在著許多令人興奮的機會。因此,儘管受到了新冠疫情帶來的諸多幹擾,但我對目前的業務運作非常有信心。但我看了我們直接控制的業務部分,我對業務的運作感到非常滿意。所以我相信我們能夠找到解決之道。我認為,隨著我們之間的距離越來越近,投資人將會更加理解這一點。

  • Robert A. Michael - Executive VP & CFO

    Robert A. Michael - Executive VP & CFO

  • So Randall, this is Rob. On your question on R&D, so if you think through the partial year synergies, the $600 million, about $400 million of that comes from R&D. And by 2022, about 50% of the greater than $2 billion in synergies will come from R&D. So while I would expect the expenses to annualize obviously with the partial year close, we'll also see those synergies ramp up. So the best way to think about it is a steady-state R&D level in the $6 billion range.

    蘭德爾,這是羅布。關於研發的問題,如果您考慮部分年度綜效,這 6 億美元中約有 4 億美元來自研發。到 2022 年,超過 20 億美元的綜效中約有 50% 將來自研發。因此,雖然我預計費用顯然會在年末時實現年度化,但我們也將看到這些協同效應的增強。因此,最好的思考方式是將穩定的研發水準控制在 60 億美元左右。

  • Operator

    Operator

  • And our next question is from Navin Jacob from UBS.

    下一個問題來自瑞銀的 Navin Jacob。

  • Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

    Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

  • Just wanted to expand on some of the opportunities that Rick had just mentioned.

    只是想擴大 Rick 剛才提到的一些機會。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Again, Navin, can you speak up a little bit?

    再說一次,Navin,你能大聲說一點嗎?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Well, let's see if we can turn our end up.

    好吧,讓我們看看是否能扭轉局面。

  • Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

    Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

  • Sure. So is this okay? Can you hear me okay?

    當然。這樣可以嗎?你聽得到我說話嗎?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • That's better.

    這樣就更好了。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

  • Better. Thank you.

    更好的。謝謝。

  • Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

    Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

  • Okay. I will yell. So with regard to...

    好的。我會大喊。因此關於…

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • We can hear you now. We turned our end up. So you don't need to yell.

    我們現在能聽到你的聲音了。我們扭轉了局面。所以你不需要大喊大叫。

  • Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

    Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic

  • All right. Fair enough. With regards to the VENCLEXTA opportunity in multiple myeloma, the CANOVA trial, wondering if you could give us an update there and how large could that potential opportunity be. Obviously, relapsed/refractory multiple myeloma is pretty competitive. So just wondering what sort of -- how we should be thinking about that, where that excitement is coming from. And then if you could remind us also about your subcutaneous version -- pump version of DUOPA that's supposed to read out in the first half of 2021. How should we be thinking about that opportunity? Could that be a blockbuster opportunity?

    好的。很公平。關於 VENCLEXTA 在多發性骨髓瘤中的應用機會,即 CANOVA 試驗,想知道您是否可以提供最新情況,以及這個潛在機會有多大。顯然,復發/難治性多發性骨髓瘤的競爭相當激烈。所以只是想知道我們應該如何思考這個問題,這種興奮來自哪裡。然後,如果您可以提醒我們關於您的皮下版本 - DUOPA 的幫浦版本,應該會在 2021 年上半年讀出。這會不會是一個一鳴驚人的機會呢?

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • This is Mike. I'll take those. With respect to VENCLEXTA, we see very real potential in the t(11;14) multiple myeloma population. If we look across our trials, early phase trials and then some set analyses of later phase trials, where we have data from t(11;14), we see very consistent responses. We see high response rates and we see long progression-free survival in the t(11;14) population. And that makes sense because that t(11;14) population has a transformed cell that has a B-cell-like phenotype and it's BCL-2 high. So it would be expected to be uniquely sensitive to VENCLEXTA and to BCL-2 inhibition. So we have the Phase III study well underway now. It's an event-driven trial. But we would hope to have data in the near future in '21. And that study is designed to confirm those earlier observations.

    這是麥克。我會接受這些。就VENCLEXTA而言,我們看到其在t(11;14)多發性骨髓瘤族群中具有非常大的潛力。如果我們回顧我們的試驗、早期試驗以及後期試驗的一些集合分析,我們有來自 t(11;14) 的數據,我們會看到非常一致的反應。我們看到 t(11;14) 族群的反應率很高,且無惡化存活期很長。這是有道理的,因為 t(11;14) 群體具有轉化細胞,該細胞有 B 細胞樣表型並且 BCL-2 水平高。因此,預計它對 VENCLEXTA 和 BCL-2 抑制具有獨特的敏感性。因此,我們現在正在順利進行第三階段的研究。這是一場事件驅動的試驗。但我們希望在21年不久的將來獲得數據。這項研究旨在證實早期的觀察結果。

  • In terms of how large an opportunity it can be, the t(11;14) population is about 20% of multiple myeloma. And multiple myeloma is a big indication. So 20% of that is a lot. Now as you mentioned, it's becoming a competitive space. But one of the advantages of having a biomarker-driven therapy is that we can identify and physicians can identify in practice what patients are likely to respond to VENCLEXTA. So we'll know what a VENCLEXTA patient looks like. And we think that will be a real opportunity and a real advantage. So we're very optimistic about that aspect of the program, and we think it represents an important additional role for VENCLEXTA.

    就其機會有多大而言,t(11;14) 族群約佔多發性骨髓瘤的 20%。多發性骨髓瘤是重要指徵。所以 20% 已經很多了。正如您所說,它現在正成為一個競爭激烈的領域。但是,生物標記驅動療法的優勢之一是,我們可以識別,醫生在實踐中也可以識別哪些患者可能對 VENCLEXTA 產生反應。這樣我們就會知道 VENCLEXTA 病人是什麼樣子的。我們認為這將是一個真正的機會和真正的優勢。因此,我們對該計劃的這個方面非常樂觀,我們認為它代表了 VENCLEXTA 的一個重要的附加作用。

  • With respect to 951, that is a program that's designed to deliver DUOPA-like efficacy through a subcutaneous insulin pump-like device. And so to do that, we had to develop 2 novel prodrugs. These are NMEs that are rapidly converted to the active agents in circulation. And they allow delivery of levodopa and carbidopa ultimately through this insulin pump-like device that you just can't do with the parent compounds because of their physical properties and chemical limitations and local tolerability limitations. So it really does represent a real breakthrough.

    就 951 而言,這是一個旨在透過皮下胰島素幫浦類裝置提供類似 DUOPA 功效的計畫。為了做到這一點,我們必須開發兩種新型前驅藥物。這些 NME 可在循環中快速轉化為活性劑。它們最終可以透過這種類似胰島素幫浦的裝置輸送左旋多巴和卡比多巴,而由於母體化合物的物理特性和化學限制以及局部耐受性限制,則無法做到這一點。所以它確實代表著一個真正的突破。

  • What we know about the efficacy of DUOPA is that it is very, very strong. It really is transformational. But it takes a lot to get that efficacy. Patients have to have a gastric tube placed to then thread it down into the small bowel. They have to maintain that. So this is a much more patient-accessible, patient-friendly, if you will, way to deliver the same sort of efficacy. And so we think that has a potential to really expand the number of patients who would be willing to consider a therapy such as 951.

    我們知道 DUOPA 的功效非常非常強。這確實具有變革性。但要達到這種功效還需要付出很多努力。患者必須放置胃管,然後將其穿入小腸。他們必須堅持這一點。因此如果你願意的話,這是一種更患者可及、更患者友善的方式來達到同樣的療效。因此我們認為這有可能真正增加願意考慮 951 等療法的患者數量。

  • And it's a big market. If you look at DUOPA, despite all the limitations, it's doing about $0.5 billion in sales. If you look at deep brain stimulation, there's also considerable use. In aggregate, this market today is well over $1 billion, probably $1.5 billion. And not all patients who would qualify by their patient profile are willing to undergo these therapies. So we think that 951 can be a very real opportunity and can be quite substantial.

    而且這是一個很大的市場。如果你看看 DUOPA,儘管有種種限制,但它的銷售額仍達到約 5 億美元。如果你觀察深部腦部刺激,你也會發現它有相當明顯的用途。整體而言,目前這個市場的規模遠遠超過 10 億美元,可能達到 15 億美元。並非所有符合條件的患者都願意接受這些治療。因此我們認為 951 是一個非常現實的機會,而且價值相當可觀。

  • Operator

    Operator

  • And our next question is from Chris Schott from JPMorgan.

    下一個問題來自摩根大通的 Chris Schott。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Great. So just two for me. The first, can you just elaborate a little bit more about how you're thinking about the size of the opportunity for RINVOQ in atopic derm now that we have the Phase III? I guess just a little bit more just how you see this fitting into the treatment paradigm. And then my second question was on the 2020 guidance. If I back out the $0.70 of Allergan accretion, it seems like the base AbbVie numbers are unchanged despite what looked like very, very strong results in the first half of the year. So just help me understand a little bit the dynamics that are happening with that kind of underlying AbbVie set of assumptions.

    偉大的。所以對我來說只有兩個。首先,您能否詳細說明一下,現在我們已經進入了第三階段,您如何看待 RINVOQ 在異位性皮膚病領域的機會規模?我想您還能再多了解一下您如何看待它與治療模式的契合。我的第二個問題是關於 2020 年的指導。如果我剔除 Allergan 增值的 0.70 美元,那麼儘管 AbbVie 上半年的業績看起來非常強勁,但其基本數字似乎沒有變化。所以請幫我稍微理解一下 AbbVie 的一系列基本假設下正在發生的動態。

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • This is Mike. I'll take the first one and then I'll hand it over to Rick for the second one. With respect to atopic dermatitis, we're very pleased with the results that we demonstrated across the Phase III trials. They actually exceeded our expectations based on the Phase IIb results. And those IIb results were very strong and had earned us a breakthrough therapy designation. And we're pleased not only with the efficacy but also with the safety profile. We've said for quite some time that one needs to look at the safety of a drug in the intended population. Because things like background therapies, risk factors in the population can have a substantial influence on what that profile looks like, not only for the active agent but for the comparator or for placebo. And if you look at the profile in the AD studies, it looks very favorable to our eye. And these were substantial studies and a substantial program overall. This wasn't a quick study to get an indication expansion. We ran a Phase III program for atopic dermatitis that could standalone for an additional submission. So we think that very strong data package will be a real advantage when we bring this indication to market.

    這是麥克。我會拿第一個,然後我會把它交給 Rick 拿第二個。關於異位性皮膚炎,我們對第三階段試驗中所展示的結果非常滿意。根據 IIb 期結果,他們實際上超出了我們的預期。這些 IIb 結果非常強勁,並為我們贏得了突破性治療的稱號。我們不僅對其功效感到滿意,而且對其安全性也感到滿意。我們早就說過,人們需要考慮藥物對目標族群的安全性。因為諸如背景療法、人群中的風險因素等因素會對該概況產生重大影響,不僅對於活性藥物如此,而且對於對照劑或安慰劑也是如此。如果你看一下 AD 研究中的概況,它在我們看來非常有利。總的來說,這些都是實質的研究和實質的計劃。這並非一項為了擴大指徵而進行的快速研究。我們開展了一項針對異位性皮膚炎的 III 期項目,該項目可以獨立進行額外提交。因此,我們認為,當我們將這項指標推向市場時,非常強大的資料包將是一個真正的優勢。

  • If you look at the size of the market overall, I think it's been underappreciated for years. Now that's changing now. There are a large number of patients who would be eligible for systemic therapy. Obviously, dupilumab is off to a good start over the past several years in that indication. But if you look at their efficacy, only about half of patients achieve an adequate response, if you consider that adequate response in EASI-75. And so in our study, we drove very good numbers there, higher than that roughly 50%, albeit there through cross-trial comparisons. So we think that there is a real opportunity for a high-efficacy agent in this space. And so it really can play on both ends of the spectrum. Patients who don't achieve an adequate response with earlier therapies, this is an obvious choice. But with the efficacy and the safety profile that we've observed, we see no reason why it wouldn't be used upfront as well. And of course, we'll have head-to-head data against dupilumab later on this year, as we said in our prepared remarks.

    如果你看一下整個市場的規模,我認為它多年來一直被低估。如今,情況正在改變。有大量患者適合接受全身性治療。顯然,dupilumab 在過去幾年中在該領域取得了良好的開端。但如果你看看它們的療效,只有大約一半的患者獲得了足夠的反應,如果你考慮到 EASI-75 中的足夠反應。因此,在我們的研究中,我們獲得了非常好的數字,高於大約 50%,儘管是透過交叉試驗比較得出的。因此我們認為,高效藥物在這一領域確實存在發展機會。因此它確實可以在光譜的兩端發揮作用。對於早期治療未能達到足夠效果的患者來說,這是一個顯而易見的選擇。但根據我們觀察到的功效和安全性,我們認為沒有理由不事先使用它。當然,正如我們在準備好的評論中所說的那樣,我們將在今年稍後獲得與 dupilumab 的正面交鋒數據。

  • Robert A. Michael - Executive VP & CFO

    Robert A. Michael - Executive VP & CFO

  • So Chris, this is Rob. I'll take your question on guidance. So if you take that $0.70 of accretion and you back off the midpoint of $10.40, it gives you a standalone of $9.70 EPS, which is $0.04 higher than our previous guidance. And it's really driven by the sales changes that we've made today. So for U.S. HUMIRA, we took that up 1%, which equals about $150 million because we're seeing less impact of COVID on continuing patients. HUMIRA OUS, we've taken up $100 million. We're seeing less erosion than we initially had planned. On RINVOQ, that's up $100 million as well, really driven by the rapid in-play share that we're seeing. And that's partially offset by MAVYRET as we've seen the market really decline during COVID. But net-net, revenue is up about $150 million, EPS, up $0.04 versus our previous guidance for stand-alone AbbVie.

    克里斯,這是羅布。我將回答您的指導問題。因此,如果您拿走 0.70 美元的增值部分,並從 10.40 美元的中點回落,那麼您的獨立每股收益將為 9.70 美元,比我們之前的預期高出 0.04 美元。這實際上是由我們今天所做的銷售變化所推動的。因此,對於美國 HUMIRA,我們將其提高了 1%,相當於約 1.5 億美元,因為我們發現 COVID 對繼續治療患者的影響較小。 HUMIRA OUS,我們已經投資了 1 億美元。我們看到的侵蝕比我們最初預期的要少。在 RINVOQ 上,這一數字也增加了 1 億美元,這實際上是由於我們看到的快速的遊戲內份額增長所致。由於我們看到市場在 COVID 期間確實下滑,因此 MAVYRET 部分抵消了這一影響。但淨收入增加了約 1.5 億美元,每股收益比我們先前對獨立 AbbVie 的預期增加了 0.04 美元。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • And the only thing I'd add on that is, obviously, we were more favorable on base AbbVie in the quarter than the $0.04. But there's still uncertainty as it relates to COVID. And so we're keeping some coverage there to see how things play out in the third quarter.

    我唯一要補充的是,顯然,本季我們對 AbbVie 的基礎評級比 0.04 美元更為看好。但與 COVID 相關的不確定性仍然存在。因此,我們會繼續關注,看看第三季的情況如何。

  • Operator

    Operator

  • And our next question is from Steve Scala from Cowen.

    下一個問題來自 Cowen 公司的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • First, congratulations on delivering ahead of expectations in the midst of a major integration, new launches and a global pandemic. It's really impressive. Rick, you stated that the impact of the pandemic was less than expected. That certainly hasn't been the case at other companies. You also said that you're seeing recovery in the aesthetics portfolio, which sounds as though it snapped back faster than the legacy AbbVie.

    首先,恭喜您在重大整合、新產品發布和全球疫情的背景下仍超出預期地完成了交付。這確實令人印象深刻。里克,您說疫情的影響比預期的要小。其他公司肯定不存在這樣的情況。您還說過,您看到美學產品組合正在復蘇,聽起來它的恢復速度比傳統的 AbbVie 更快。

  • So I'm just curious, to what do you attribute these dynamics? And do you expect the second half of the year to look more like the first half or more like May and June relative to patient volumes, clinic traffic and so forth? And then secondly, you stated that you expect margin improvement over the next few years. Could you provide some parameters around that expectation?

    所以我很好奇,您認為這些動態的原因是什麼?您是否預計,從患者數量、診所流量等方面來看,下半年的情況會更像上半年,還是更像 5 月和 6 月?其次,您表示預計未來幾年利潤率會提高。您能否提供一些符合該期望的參數?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Okay. So this is Rick. I'll take the first one. Your observation is correct. So I think the way to think about it is that both in the second quarter, many of the assets didn't drop as far as we expected. That was part of the favorability. I'd say that was particularly the case in a number of areas in the legacy AbbVie portfolio associated with the business. On the aesthetics, it is pretty much the way you're describing it. What we saw happening in the aesthetics business and to a very similar extent to BOTOX Therapeutic is that we saw a rapid drop in the case of aesthetics as those practices virtually closed. I'd say almost all, if not all of the practices had closed. So aesthetic revenues dropped significantly for a period of time in that mid-April time frame. As we started to see geographies remove the shelter-in-place orders around the U.S., we saw the aesthetics practices quickly put in place safety measures to be able to allow patients to come back into their offices. And I'd say the vast majority of those practices ramped back up and went back into doing procedures fairly quickly.

    好的。這就是里克。我選擇第一個。你的觀察是正確的。因此,我認為應該這樣考慮:第二季度,許多資產的跌幅並沒有像我們預期的那麼大。這也是有利因素的一部分。我想說,在與該業務相關的傳統 AbbVie 產品組合中的許多領域中,情況尤其如此。從美學角度來看,它幾乎就像您所描述的那樣。我們看到美容行業發生的情況與 BOTOX 治療非常相似,隨著美容行業實際上已經關閉,美容行業的情況急劇下降。我想說,幾乎所有(如果不是全部的話)診所都關閉了。因此,四月中旬的一段時間內,美容收入大幅下降。當我們開始看到美國各地取消「就地避難」的命令時,我們看到美容診所迅速採取了安全措施,以便讓患者返回診所。我想說,絕大多數此類業務都已恢復正常,並很快恢復了正常運作。

  • As we approached that mid-May time frame, we actually saw -- let's take BOTOX as an example. And BOTOX would be the leading indicator because it's the procedure -- BOTOX Cosmetic, it is the procedure that people would go to first. It ramped back up, went well over 100% of pre-COVID levels to around 120%, 125%. And then it -- and that was obviously pent-up demand that was coming back into the channel, so patients returned quickly. And then as that pent-up demand started to burn off as we got through June, you started to see it drop back down. And now it's settled in sort of in the mid-90s right now. We think it will reach -- it will stabilize back up over the course of third quarter, back close to pre-COVID levels and then start growing again. And so I can tell you, I'm extremely pleased with how both aesthetics and BOTOX Therapeutics had returned. I think it's a testament of those brands and those patients.

    當我們接近五月中旬時,我們實際上看到了——讓我們以 BOTOX 為例。而 BOTOX 將成為領先指標,因為它是 BOTOX 美容程序,是人們首先會採用的程序。它又回升了,遠遠超過了新冠疫情之前水準的 100%,達到 120% 到 125% 左右。然後 — — 這顯然是被壓抑的需求重新回到了管道,所以患者很快就回來了。然後,隨著 6 月被壓抑的需求開始消退,你會看到它開始回落。現在它已經穩定在 90 年代中期了。我們認為它將在第三季度重新穩定下來,回到接近疫情之前的水平,然後再次開始成長。因此我可以告訴你,我對美學和 BOTOX 治療的恢復感到非常高興。我認為這是對這些品牌和這些患者的證明。

  • As far as the assumptions we made in the second half, obviously, we're assuming the second half performs a lot better than the first half. We're not assuming any kind of a broad-based shelter in-place activity. And we'll continue to see more and more patients come back into physicians' offices. On the AbbVie side of the business, we are monitoring those patients by individual practice. It's appropriate for our particular businesses. And I'd say, for the most part, they are returning close to pre-COVID levels. They do vary a little bit by specialty. As an example, rheum and GI have come back faster than medical derm has. But medical derm has returned as well, to some extent, and we're continuing to see it return. Oncology practices in certain conditions, we've seen -- we saw some tailing off of CLL treatment in the second quarter. That's now returning back to normalized levels. So I think the second half will obviously be much better than the first half. And I think we should return to normalized levels as we proceed through the second half of the year. Rob, anything you want to add on that?

    就我們對下半年所做的假設而言,顯然,我們假設下半年的表現會比上半年好得多。我們不假設會採取任何形式的大範圍的就地避難活動。我們將繼續看到越來越多的患者回到醫生的辦公室。在 AbbVie 業務方面,我們透過個別實踐監控這些患者。它適合我們的特定業務。我想說,總體而言,它們已恢復到接近疫情之前的水平。它們確實因專業不同而略有不同。例如,風濕病和胃腸病的恢復速度比醫學皮膚病學的恢復速度要快。但在某種程度上,醫學皮膚科也已經回歸,而且我們正在繼續看到它的回歸。在某些情況下,我們看到腫瘤學實踐——第二季度 CLL 治療有所減少。現在已恢復到正常水平。所以我認為下半年顯然會比上半年好很多。我認為,隨著今年下半年的到來,我們應該會恢復正常水準。羅布,你還有什麼要補充嗎?

  • Robert A. Michael - Executive VP & CFO

    Robert A. Michael - Executive VP & CFO

  • I can answer the question on margin. Steve, this is Rob. On operating margin, I think when you think about we have a partial year of synergies and a top line that's been pressured by COVID, we have a 48% operating margin profile. As you think about '21 and '22, we're going to obviously run -- we're going to ramp those synergies as well as we'll see top line growth and where you'd see the P&L leverage that we've demonstrated in past year. So I would expect to see our operating margin expand in '21 and '22. With 2023, with the U.S. HUMIRA event, obviously, we would see operating margin pulled back. But I would expect it to be in the 45% range, which still puts us top tier in the industry.

    我可以回答有關保證金的問題。史蒂夫,這是羅布。關於營業利益率,我想,當你考慮到我們在一年中部分時間的協同效應和受到 COVID 壓力的營收時,我們的營業利潤率為 48%。當您想到'21和'22時,我們顯然會運行--我們將增強這些協同效應,同時我們將看到營收成長,以及您將看到我們在過去一年中展示的損益槓桿。因此,我預計我們的營業利潤率將在21年和22年擴大。隨著 2023 年美國 HUMIRA 事件的發生,顯然我們會看到營業利潤率回落。但我預計它會在 45% 的範圍內,這仍然使我們處於行業領先地位。

  • Operator

    Operator

  • Our next question is from Geoffrey Porges from Leerink.

    我們的下一個問題來自 Leerink 的 Geoffrey Porges。

  • Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

    Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst

  • Congratulations. Very helpful to get the guidance. Could you talk a little bit about atogepant? Particularly, what's the size of the addressable opportunity for the full portfolio of oral migraine medicines? And perhaps how much of an issue is the constipation data that you've seen? And then Rick, look, there's a massive economic disruption going on. And I'd be interested in your commentary about how consumers and payers are reacting to that disruption and how that's factored into your guidance. Are we seeing switches from IV to oral, from generic to brand? How is that playing out in your experience and observation?

    恭喜。獲得指導非常有幫助。可以談談 atogepant 嗎?具體來說,口服偏頭痛藥物的全部產品組合的潛在機會有多大?也許您所看到的便秘數據有多大問題?然後里克,你看,大規模的經濟混亂正在發生。我很想知道您對消費者和付款人如何應對這種中斷的評論,以及這對您的指導有何影響。我們是否正在經歷從靜脈注射到口服、從仿製藥到品牌藥的轉變?從您的經驗和觀察來看,這是如何發生的?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • All right. Great. So maybe we'll have Mike talk a little bit about the profile of the drug. And what I'd say is I think we probably want to come back at a later date once we've had a little better opportunity to analyze the chronic migraine market. And it's going to depend, to a great extent, on the profile of the drug, obviously. But it's a very large market, a very significant market. And -- but Mike, maybe if you want to talk a little bit about constipation and then I'll come back and talk about the payer dynamics.

    好的。偉大的。因此我們或許應該讓麥克談談這種藥物的概況。我想說的是,一旦我們有了更好的機會來分析慢性偏頭痛市場,我們可能會希望稍後再回來。顯然,這在很大程度上取決於藥物的特性。但這是一個非常大的市場,一個非常重要的市場。而且 — 但是麥克,也許你想談談便秘,然後我會回來談談付款人動態。

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • Sure. I'll talk about atogepant. We're very pleased with the data we've seen. And of course, this fits into an important part of our migraine portfolio with UBRELVY for acute migraine, now with atogepant with 2 data readouts in episodic migraine and an ongoing program in chronic migraine. And of course, there's BOTOX Therapeutic in chronic migraine, so it really rounds out our portfolio. The efficacy that we saw was very strong. As we said in our prepared remarks, we hit the primary and all secondaries across the 2 upper doses and the primary and 4 out of 6 secondaries for the lowest dose studied. So that is an efficacy profile that I think exceeded our expectations going into the study.

    當然。我來談談 atogepant。我們對所看到的數據非常滿意。當然,這屬於我們偏頭痛產品組合的重要組成部分,該組合包括用於治療急性偏頭痛的 UBRELVY,現在又增加了用於治療發作性偏頭痛的 atogepant(有 2 個數據讀數)和用於治療慢性偏頭痛的正在進行的項目。當然,我們也有用於治療慢性偏頭痛的 BOTOX 治療劑,因此它確實完善了我們的產品組合。我們看到的功效非常強。正如我們在準備好的評論中所說的那樣,我們在研究的 2 個較高劑量中達到了主要劑量和所有次要劑量,在研究的最低劑量中達到了主要劑量和 6 個次要劑量中的 4 個。所以,我認為該功效概況超出了我們研究時的預期。

  • With respect to the safety, our view of the safety profile looks very favorable. The constipation that was observed in the overwhelming majority of cases was mild or moderate. It didn't limit treatment. So patients stayed on treatment. They could be managed easily with interventions like stool softeners or fiber supplementation. So we don't see it as something that is limiting, particularly in light of the very strong efficacy that we have demonstrated. And the only other point I'd add is that we have a good understanding of it and it's on target. So it comes with the efficacy, you get a very strong efficacy and you have this manageable tolerability profile that I described.

    就安全性而言,我們對其安全性的看法非常樂觀。絕大多數病例中觀察到的便秘是輕度或中度的。它沒有限制治療。因此患者繼續接受治療。可以透過大便軟化劑或纖維補充劑等乾預措施輕鬆控制這些問題。因此,我們並不認為它有什麼限制,特別是考慮到我們已經證明的非常強的功效。我唯一想補充的另一點是,我們對此有很好的理解,並且達到了目標。因此,它具有功效,您可以獲得非常強的功效,並且具有我所描述的可管理的耐受性。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Geoff, on the -- on your second question, you probably recall back on our first quarter guidance, when we outlined that we had built in to our forecast for the remainder of the year some impact for some channels shifting that we thought could occur due to the high unemployment. And essentially, we haven't seen much of that at all. In fact, I would tell you, we haven't seen any of it to any material effect right now. And one of the things that we do to watch that carefully is our PAP program. We've been advertising extensively to consumers to make sure that they know if they lost their insurance or they lost their jobs and they don't have insurance coverage and they can't afford their AbbVie medicines to come to us. We have a very extensive patient assistance program. And we're not seeing any significant increase in those requests. It could be because of the furloughs. We're not 100% sure yet. And potentially, we could see some increase as we go further here, depending upon what happens with stimulus programs going forward. We have still maintained some level of coverage in our forecast that we're providing now. So we believe we have sufficient coverage to deal with it, and we'll just have to see how it sorts itself out.

    傑夫,關於你的第二個問題,你可能還記得我們第一季的指引,當時我們概述了我們已經將對今年剩餘時間的預測納入了我們認為由於高失業率可能會發生的一些管道轉變的影響。但實際上,我們根本沒看到太多這樣的情況。事實上,我想告訴你,我們目前還沒有看到任何實質的影響。我們為密切關注這一情況所採取的措施之一就是我們的 PAP 計劃。我們一直在向消費者廣泛宣傳,確保他們知道,如果他們失去保險或失業,沒有保險保障,就無法負擔 AbbVie 藥品的費用。我們有一個非常廣泛的病人援助計劃。但我們並未看到這些請求有任何明顯增加。這可能是因為休假。我們還不是100%確定。而且,隨著我們進一步推進,我們可能會看到一些成長,這取決於未來刺激計畫的進展。我們現在提供的預測仍然保持了一定程度的覆蓋範圍。因此我們相信我們有足夠的保障來處理這個問題,我們只需要看看它如何自行解決。

  • Operator

    Operator

  • Our next question is from Vamil Divan from Mizuho.

    下一個問題來自瑞穗的 Vamil Divan。

  • Vamil Kishore Divan - MD

    Vamil Kishore Divan - MD

  • Maybe just to continue on the migraine question. You mentioned UBRELVY and the potential there. Can you maybe just talk a little bit about the net pricing that you're thinking about in that space? I guess maybe relative to the injectable antibodies that are helpful for prevention already, there's only the 2 players, it sounds like, here between you and Biohaven -- or on the injectable side. So just trying to get a sense how you see this sort of pricing dynamic play out. We're getting a lot of questions on that front.

    也許只是繼續討論偏頭痛的問題。您提到了 UBRELVY 及其潛力。您能否稍微談談您在該領域考慮的淨定價?我想也許相對於已經有助於預防的注射抗體而言,聽起來只有你和 Biohaven 之間的兩個參與者——或者在註射方面。所以只是想了解您如何看待這種定價動態的發揮作用。我們收到了很多這方面的疑問。

  • And then maybe for Rick, I'm just curious around some of the executive orders we've seen on the drug pricing side for the administration. I don't know if I may have missed your comments earlier, but just curious if you have any sort of additional thoughts about what you heard from some of your peers on this issue this week on their calls. But every company obviously has a different product mix and maybe some different perspectives. So curious what your views are especially as it relates to the rebate rule order.

    然後也許對里克來說,我只是對我們在政府藥品定價方面看到的一些行政命令感到好奇。我不知道我是否錯過了您之前的評論,但我只是好奇您是否對本週在電話中聽到的一些同事就此問題發表的看法還有其他想法。但顯然每家公司都有不同的產品組合,也許還有不同的看法。我很好奇您的觀點,特別是與回扣規則命令相關的觀點。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Right. Okay. I'll cover both of those questions. So on migraine, I mean, obviously, we don't publicly talk about our net price. We have fairly significant managed care coverage on the asset already. I think it's about 70%. And obviously, it had to be priced in a way that was appropriate to be able to get that level of coverage. This is a market where market expansion is important. As I said, I think if you look at the penetration right now of acute migraine products, against the -- or at least the oral CGRPs against the total migraine acute market, it's about 12% penetrated right now.

    正確的。好的。我將回答這兩個問題。因此,關於偏頭痛,我的意思是,顯然,我們不會公開談論我們的淨價。我們已經對該資產提供了相當重要的管理式護理覆蓋。我認為大約是 70%。顯然,它必須以合理的價格才能獲得這種程度的覆蓋。這是一個市場擴張非常重要的市場。正如我所說的,我認為,如果您看看現在急性偏頭痛產品的滲透率,相對於——或者至少是口服 CGRP 相對於整個偏頭痛急性市場的滲透率,目前的滲透率約為 12%。

  • So there's a significant opportunity to be able to grow that market. And it gives you some idea of the magnitude of this market. So you certainly want it to be in a position where it can have access to be able to allow patients to be able to use the products. These products certainly have demonstrated that they have strong demand from patients to be able to provide them appropriate levels of relief. And so I would just tell you that, that's an important aspect of the overall strategy here is to be able to grow this market over the long term.

    因此,有很大機會能夠擴大該市場。它可以讓您了解這個市場的規模。所以你肯定希望它能讓患者能夠使用這些產品。這些產品確實顯示了它們對患者有強烈的需求,希望能為患者提供適當程度的緩解。所以我想告訴你,這是整體策略的一個重要方面,就是能夠長期發展這個市場。

  • On the executive orders, as you have probably seen, they're pretty high level at this point and they provide some high-level direction. So I think until we see them sort of start to sort out, I think it's a little difficult to give you a lot of specificity around what they look like. Now I will say, if I look at them in the backdrop of AbbVie's business, I would say I don't think they will have a significant impact on our business. If you look at Part B, as an example, we have a very small Part B business. I think it's around 2% to 3%. 3%, I guess, is the right number now. So it's a very insignificant part. If you look at the importation bill or executive order, it's very similar to what's already been given out to the states. And it excludes biologics, which obviously is an important part of our business. If you look at the third one, it's insulin and EpiPen. We're not in that business.

    關於行政命令,正如你可能已經看到的,它們目前的級別相當高,並且提供了一些高層指導。因此我認為,直到我們看到它們開始理清思緒之前,我們很難具體地知道它們是什麼樣子。現在我想說,如果我從 AbbVie 的業務背景來看它們,我會說我認為它們不會對我們的業務產生重大影響。以 B 部分為例,我們的 B 部分業務非常小。我認為大概在 2% 到 3% 左右。我想,3% 是現在的正確數字。所以這只是非常微不足道的部分。如果你看進口法案或行政命令,你會發現它與已經發給各州的法案或行政命令非常相似。並且它不包括生物製劑,但這顯然是我們業務的重要組成部分。如果你看第三個,它是胰島素和EpiPen。我們不從事那項業務。

  • And then the rebate rule. Certainly, as we look at rebates, we're absolutely supportive of patients being able to get the benefit of the discount associated with the rebate or discount. As we've said many times before, for us, whether it's a rebate or a discount is not very material to us. What I would say is, when I look at that executive order, it does say that you have to be able to implement it without increasing premiums. And everything I know about how rebates are redistributed, I would say that I think that, that will be difficult to do. So I don't know how that will ultimately play out, so -- I mean at a high-level look at what we think about them right now. But I think right now, I wouldn't anticipate that they have a significant risk associated with AbbVie.

    然後是折扣規則。當然,當我們考慮回扣時,我們絕對支持患者能夠獲得與回扣或折扣相關的折扣優惠。正如我們之前多次說過的,對我們來說,回扣或折扣對我們來說都不是很重要。我想說的是,當我看到那項行政命令時,它確實說你必須能夠在不增加保費的情況下實施它。就我所知,關於回扣如何重新分配,我想說的是,我認為這將很困難。所以我不知道最終結果會如何,所以——我的意思是從高層次看看我們現在對它們的看法。但我認為現在,我不會預料到他們會面臨與 AbbVie 相關的重大風險。

  • Operator

    Operator

  • And our next question is from David Risinger from Morgan Stanley.

    下一個問題來自摩根士丹利的 David Risinger。

  • David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst

    David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst

  • Great. And congrats on all of the encouraging updates. So first, Rick, could you please discuss maybe in a little bit more detail the most significant revenue synergy opportunities you see as a result of the combination with Allergan? I know that the combined company can do more with certain franchises. But if you could put some finer points on that, that would be very helpful.

    偉大的。並恭喜所有令人鼓舞的更新。首先,里克,您能否詳細討論一下與 Allergan 合併後您認為最重要的收入協同機會?我知道合併後的公司可以在某些特許經營方面做得更多。但如果你能對此提出一些更詳細的說明,那將會非常有幫助。

  • Then second, with respect to next year's readouts, AbbVie has a very large pipeline of Phase II candidates with proof-of-concept readouts in 2021. But could you point us to the ones that have the biggest commercial potential? So if there is validation in 2021, what are the biggest product opportunities that we should be paying attention to? And then one little tidbit. The UBRELVY number was $22 million in the quarter. That was strong. How much stocking was in there?

    其次,關於明年的讀數,AbbVie 擁有大量 II 期候選藥物,並將於 2021 年獲得概念驗證讀數。那麼,如果 2021 年得到驗證,我們應該關注的最大產品機會是什麼?接下來是一個小花絮。本季的 UBRELVY 數字為 2,200 萬美元。那很強。裡面有多少襪子?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Okay. So I'll cover the first one and then I'll have Mike cover the second and Rob can cover the third. So if I look at the business overall, I said that the integration has gone very seamlessly. And I think that's a tribute to all the planning that we did. We had some extra time to be able to do it and I think that benefited us. And so I think the 2 organizations have come together in a way that's been quite good. Now I would say I think the places where we have an opportunity to be able to provide some synergy and benefit, certainly, when you look at our therapeutic businesses, when you look at our -- many of the tactical kinds of execution techniques that we use in the marketplace, I think many of those are applicable to the Allergan therapeutic portfolio. Certainly, when you look at managed care, that's an area that we have demonstrated that we're quite skilled at being able to effectively manage our way through that.

    好的。因此我將負責第一個,然後讓 Mike 負責第二個,Rob 負責第三個。因此,如果我從整體上看業務,我會說整合進行得非常無縫。我認為這是對我們所做所有規劃的讚揚。我們有一些額外的時間來完成這項工作,我認為這對我們有好處。因此我認為,這兩個組織之間的合作非常好。現在我想說,我認為我們有機會提供一些協同效應和利益的地方,當然,當你看看我們的治療業務時,當你看看我們在市場上使用的許多戰術執行技術時,我認為其中許多都適用於艾爾建的治療產品組合。當然,當您看一下管理式醫療時,我們已經證明,我們非常擅長有效地管理這一領域。

  • And then the third area I'd say is if I look at aesthetics, aesthetics is a very attractive market. It has a significant opportunity to be able to grow that market, which I mean by bringing in more people into the market more quickly. You can do that several different ways. Obviously, some of it is driven by promotional activity. I'd say Allergan is very skilled from a social media standpoint. And I think that's an area that's probably been underfunded. Historically, it's an area that we have a high level of interest in funding to a greater extent. And we obviously have the financial wherewithal to be able to do that.

    我想說的第三個領域是,如果從美學的角度來看,美學是一個非常有吸引力的市場。它有很大機會能夠擴大該市場,我的意思是透過更快地吸引更多人進入市場。您可以透過多種不同方式來實現這一點。顯然,其中一些是由促銷活動推動的。我想說,從社群媒體的角度來看,艾爾建非常熟練。我認為這個領域可能資金不足。從歷史上看,我們對該領域有很高的資助興趣。而我們顯然有足夠的財力來實現這一點。

  • The second thing is being able to bring more new innovation more rapidly into that market. And I think that's an area that we'll also be able to provide a benefit both in the way we operate R&D and the ability to be able to rapidly innovate. I think that will be a benefit to the overall business. And I think we have an opportunity to be able to accelerate the growth of that business in a meaningful way over time. And it's a market I like a lot, I think, both based on demographics, the cash pay aspects of it and how it responds to appropriate innovation in that market. So that's an area that I think, over time, you can expect us to continue to make sure that we're doing what we know how to do to be able to ultimately grow that market over the long term. Those would be some of the things I'd tell you at a high level. Mike?

    第二件事是能夠更快地將更多新創新引入該市場。我認為,我們也可以在研發運作方式和快速創新能力方面提供益處。我認為這對整個業務有利。我認為我們有機會隨著時間的推移以有意義的方式加速該業務的成長。我認為我非常喜歡這個市場,既基於人口統計,也基於它的現金支付方面,以及它如何響應該市場的適當創新。因此,我認為,隨著時間的推移,你可以期待我們繼續確保我們正在做我們所知道該做的事情,以便最終能夠長期發展這個市場。這些就是我想從高層告訴你的一些事情。麥克風?

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • I'll take the second question. So we do, as you point out, have a number of data readouts from Phase II studies or other proof-of-concept studies in 2021 and also in the following years, in 2022 and beyond. And a number of these are very large opportunities. I'd point to our oncology programs. We have a number of immuno-oncology programs that would be large opportunities if they hit. Our GARP program, I think, is a very good example of that. Our bispecifics, I think, are a very good example of that. We just brought in, through the Genmab collaboration, epcoritamab, which is a large opportunity. Obviously, that's post proof of concept. But there are 2 additional molecules there that are just a little bit earlier in development that could be large opportunities. We have bispecifics in BCMA, more than one program that could be very large opportunities if they were, in fact, best-in-class. And we think they have the potential to be best-in-class.

    我來回答第二個問題。因此,正如您所指出的,我們確實擁有 2021 年以及接下來幾年(2022 年及以後)的 II 期研究或其他概念驗證研究的大量數據讀數。其中很多都是巨大的機會。我想指出我們的腫瘤學課程。我們有多個免疫腫瘤學項目,如果成功,將帶來巨大的機會。我認為,我們的 GARP 計劃就是一個很好的例子。我認為,我們的雙特異性抗體就是一個很好的例子。我們剛剛透過與 Genmab 的合作引進了 epcoritamab,這是一個巨大的機會。顯然,這是概念驗證的後續。但還有另外兩種分子處於開發初期,可能帶來巨大的機會。我們在 BCMA 中擁有多個雙特異性抗體項目,如果它們確實是同類最佳,那麼可能會帶來非常大的機會。我們認為他們有潛力成為同類中的佼佼者。

  • The last thing I would point to in oncology is our novel, so targeted ADC technology with ABBV-155 being in the lead in non-small cell lung cancer. That is a BCL-XL warhead targeted by a B7-H3 antibody. If that were to hit, and we'd see those data next year, that would be a large opportunity. Obviously, in immunology, we're advancing our TNF steroid program. But I think those are data that we've already reported out. And then the last thing that I would mention is in our neuroscience portfolio. Obviously, Alzheimer's disease, if those programs were to hit, they would be a very large opportunity, given the enormous unmet medical need. Now obviously, in Alzheimer's disease, it's higher risk, higher reward. But if we got favorable data, it would be a very, very meaningful opportunity.

    在腫瘤學方面我要指出的最後一件事是我們新穎的、有針對性的 ADC 技術,其中 ABBV-155 在非小細胞肺癌領域處於領先地位。那是一枚以 B7-H3 抗體為目標的 BCL-XL 彈頭。如果這一目標實現,並且我們明年能看到這些數據,那麼這將是一個巨大的機會。顯然,在免疫學方面,我們正在推進我們的 TNF 類固醇計劃。但我認為這些是我們已經報告的數據。我最後要提到的是我們的神經科學組合。顯然,對於阿茲海默症來說,如果這些計畫能夠成功,那麼考慮到巨大的未滿足的醫療需求,這將是一個非常大的機會。顯然,阿茲海默症的風險更高,回報也更高。但如果我們獲得有利的數據,這將是一個非常非常有意義的機會。

  • Robert A. Michael - Executive VP & CFO

    Robert A. Michael - Executive VP & CFO

  • And David, this is Rob. On UBRELVY. If you look at just the full quarter revenue of $27 million, it really follows the prescription growth on a sequential basis. So there's really a negligible stocking impact. And we'd expect to see continued sequential growth for that product.

    大衛,這是羅布。在 UBRELVY 上。如果只看整個季度 2700 萬美元的收入,它實際上是按照處方藥的連續增長來計算的。因此,庫存影響實際上可以忽略不計。我們預計該產品將繼續連續成長。

  • Operator

    Operator

  • Our next question is from Chris Raymond from Piper Sandler.

    下一個問題來自 Piper Sandler 的 Chris Raymond。

  • Christopher Joseph Raymond - MD & Senior Research Analyst

    Christopher Joseph Raymond - MD & Senior Research Analyst

  • Just back to atogepant in sort of a competitive setup. So Rick, I heard your comments on how this is underappreciated. We've done some checks to see if it indicated that, that's the case. And I know this -- it's not approved yet. So pardon, if you don't mind, the commercial question here. But there's been some chatter out there, especially from some Biohaven [bulls] that placebo-adjusted migraine days maybe don't matter as much as absolute days. And so just maybe, you're in the field with UBRELVY, from a rep-to-doc dialogue perspective, what do you guys see as the most important attribute, especially as you'll be positioning this in the prevention setting versus subcus and the other oral therapies -- or the other oral therapy that happens to be a dissolving tablet?

    剛剛回到 atogepant 的一種競爭設置中。所以里克,我聽到了你關於這一點被低估的評論。我們進行了一些檢查,看看是否表明確實如此。我知道這一點——它尚未獲得批准。所以如果您不介意的話,請原諒我這裡問的是商業問題。但外界也有一些議論,尤其是一些 Biohaven [支持者] 認為,安慰劑調整後的偏頭痛天數可能不如絕對天數那麼重要。因此,也許您在 UBRELVY 領域,從代表與醫生對話的角度來看,您認為最重要的屬性是什麼,尤其是當您將其定位在預防環境中而不是皮下注射和其他口服療法 - 或者恰好是溶解片的其他口服療法時?

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • Well, this is Mike. I'll take the first part of that and then Rick may want to add. With respect to efficacy, the most important attribute is the placebo-adjusted migraine days. If one were solely to look at the total days, one could conclude that placebo is, in fact, a good therapy for these patients because we see reductions. And so you have to account for that. And there are differences from study-to-study based on design, population enrolled and what that placebo difference is. So it absolutely has to be taken into account. And when you look at our placebo-adjusted results, they're very strong. They range between 1.2 and 1.7 days, which in this disease area is a very meaningful response rate. And it's higher than what has been reported with other oral agents, obviously with the caveat of a cross-trial comparison. So we think that on the most important efficacy parameter, we performed very, very well. And of course, we've hit all the secondaries across 2 of those 3 doses, as I've described. And as we get the data out into the public domain, you'll get more color on that.

    嗯,這是麥克。我將討論第一部分,然後 Rick 可能會進行補充。就療效而言,最重要的特性是安慰劑調整的偏頭痛天數。如果只看總天數,就可以得出結論,安慰劑實際上是這些患者的良好治療方法,因為我們看到了減少。所以你必須考慮到這一點。而且,根據研究設計、研究對像以及安慰劑差異,各項研究之間也存在差異。因此絕對必須考慮到這一點。當您查看我們經過安慰劑調整的結果時,您會發現它們非常強勁。它們的範圍在 1.2 到 1.7 天之間,在這個疾病領域,這是一個非常有意義的反應率。而且它高於其他口服藥物的報告水平,顯然需要進行交叉試驗比較。因此我們認為,在最重要的功效參數上,我們的表現非常非常好。當然,正如我所描述的,我們在 3 劑中的 2 劑中達到了所有次要效果。當我們將資料發佈到公共領域時,您將獲得更詳細的資訊。

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Yes. I would just reiterate what Mike says. I mean physicians are well skilled in understanding what placebo rates are. And I just don't even think it's appropriate not to represent a product's efficacy without looking at the placebo rate. So I mean I think that will be the way doctors look at it. And I think that is the way the products will be marketed. And certainly, if I had a lower rate, I may have an interest in that. But at the end of the day, I think that is the appropriate way to look at it.

    是的。我只是想重申麥克所說的話。我的意思是醫生非常了解安慰劑率。我甚至認為,不看安慰劑率就不能說明產品的功效。所以我的意思是我認為這將是醫生看待此事的方式。我認為這就是產品的營銷方式。當然,如果我的利率較低,我可能會對此感興趣。但最終,我認為這是看待這個問題的正確方法。

  • Operator

    Operator

  • Our next question is from Tim Anderson from Wolfe Research.

    我們的下一個問題來自 Wolfe Research 的蒂姆·安德森。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • A few pipeline questions, please. On the TNF steroid conjugate, some KOLs have a mixed view of that approach. For those that are skeptical, what's the most common reason that you hear? Second question on VRAYLAR, what are your odds of regulatory success in depression? Even just qualitatively, is this a high-risk, medium-risk or low-risk endeavor? And then can you clarify why your Genmab CD3xCD20 would be best-in-class?

    請問幾個管道問題。對於TNF類固醇結合物,一些KOL對此方法有不同的看法。對於那些持懷疑態度的人,您聽到的最常見的原因是什麼?關於 VRAYLAR 的第二個問題,您在憂鬱症治療方面成功的幾率有多大?即使僅從品質來看,這是一個高風險、中等風險還是低風險的事業?那麼您能解釋一下為什麼您的 Genmab CD3xCD20 是同類產品中最好的嗎?

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • Okay. I'll take those questions. With respect to the TNF steroid conjugate, what I would say is, it's important to keep in mind that this is an early phase trial and this was intended to be a proof-of-concept trial. One can't do a fully powered head-to-head against an active competitor like HUMIRA in Phase I or Phase II because that typically requires or always requires essentially a large Phase III study. Head-to-head studies are often amongst the largest studies in a Phase III program. So what we were looking for was evidence to support the profile that I described, which is that we had a high probability of success in those trials downstream. If folks have a mixed view, then what we hear is they'd like to see those later data. And what I would say is we're well on the path to generating them. We're pleased with the results that we've seen, and we think it's a very promising platform, and we're going to be advancing into larger-scale trials and people will get the data that they're looking for.

    好的。我將回答這些問題。關於 TNF 類固醇結合物,我想說的是,重要的是要記住這是一個早期試驗,並且旨在作為概念驗證試驗。在第一階段或第二階段,人們無法與 HUMIRA 這樣的活躍競爭對手進行全面正面交鋒,因為這通常需要或總是需要進行大規模的第三階段研究。頭對頭研究通常是 III 期計畫中規模最大的研究之一。因此,我們正在尋找證據來支持我所描述的情況,即我們在後續試驗中取得成功的機率很高。如果人們有不同的看法,那麼我們聽到的是他們希望看到後續數據。我想說的是,我們已經在創造這些能力的道路上取得了巨大的進展。我們對所看到的結果感到滿意,我們認為這是一個非常有前景的平台,我們將推進更大規模的試驗,人們將獲得他們想要的數據。

  • With respect to VRAYLAR in the adjunctive treatment of major depressive disorder, I think the question was how would I characterize the risk there? There already is one positive study in hand. And so of the 2 studies that are underway, we would need one additional study to read out positive to support the indication. I think that historically, this has been a challenging indication. But I think the -- both the rationale and the data from earlier studies in the VRAYLAR program are strong. So I would probably put it in the moderate probability range. We didn't build it into our model. Our success with VRAYLAR was not dependent on it. But we think it represents a very attractive upside opportunity if, in fact, it hits.

    關於 VRAYLAR 在重度憂鬱症輔助治療中的作用,我認為問題在於我如何描述其風險?目前已有一項積極的研究。因此,在正在進行的兩項研究中,我們還需要一項額外研究來得出積極結論以支持該指徵。我認為從歷史上看,這是一個具有挑戰性的跡象。但我認為 VRAYLAR 計畫早期研究的理由和數據都很有力。所以我可能會把它放在中等機率範圍內。我們沒有將其納入我們的模型中。我們與 VRAYLAR 的成功並不依賴它。但我們認為,如果它真的實現,這將代表一個非常有吸引力的上行機會。

  • And with respect to why Genmab CD3xCD20 has the potential to be best-in-class? I would point to 2 things. One is the efficacy data reported from the early phase trials, particularly in DLBCL, which is a very difficult-to-treat tumor type, puts it at the higher end of efficacy. And the safety profile has been very favorable in terms of what's been observed to date, both with respect to cytokine release syndrome and the lack of occurrence in the early phase trials of higher-grade CRS and also with respect to the neurological symptoms that can accompany this class of therapy. So it seems to have threaded that sweet spot between achieving very strong efficacy with a good safety profile. It also has subcu administration with its existing formulation. Others are working towards that. But Genmab already has the data in hand. And the dosing schedule fits very well into the regimens that will be used in the diseases that we'd study, particularly DLBCL and follicular lymphoma. So we see aggregate of that, that we think gives it a very, very strong profile.

    為什麼 Genmab CD3xCD20 有可能成為同類最佳產品?我要指出兩件事。一是早期試驗報告的療效數據,特別是在 DLBCL 這種極難治療的腫瘤類型中,其療效處於較高水平。從迄今為止的觀察來看,其安全性非常好,無論是在細胞激素釋放綜合徵方面,還是在早期試驗中沒有出現高級別 CRS,還是在可能伴隨此類治療的神經系統症狀方面。因此,它似乎在實現非常強的療效和良好的安全性之間找到了最佳平衡點。它也可以採用現有的配方進行皮下給藥。其他人也正在為此努力。但 Genmab 已經掌握了數據。且給藥方案非常符合我們研究的疾病(特別是 DLBCL 和濾泡性淋巴瘤)的治療方案。因此,我們認為,綜合起來看,這賦予了它非常非常強大的形象。

  • Operator

    Operator

  • Our final question today is from Terence Flynn from Goldman Sachs.

    今天的最後一個問題來自高盛的特倫斯弗林 (Terence Flynn)。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • Congrats on the Allergan integration. You mentioned in your comments that RINVOQ uptakes accelerating here, was just wondering if you could provide a little bit more color on that. Is that being driven by COVID and maybe teleprescribing having an advantage over some of the injectables? And if so, do you see that as being a durable change here as we come out of the pandemic? And then the second one I had was just on VENCLEXTA. I noticed you're running some trials for solid tumors. Maybe just remind us of the rationale here behind that approach. And how optimistic are you there as you move into later stages?

    恭喜與 Allergan 的整合。您在評論中提到 RINVOQ 的吸收在這裡正在加速,我只是想知道您是否可以提供更多詳細資訊。這是由 COVID 推動的嗎?如果是這樣,您是否認為當我們走出疫情後,這將帶來持久的變化?然後我第二次服用的是VENCLEXTA。我注意到您正在進行一些針對實體腫瘤的試驗。也許只是提醒我們這種方法背後的理由。當進入後期階段時,您有多樂觀?

  • Richard A. Gonzalez - Chairman & CEO

    Richard A. Gonzalez - Chairman & CEO

  • Okay. Thanks. I'll take the first question. Mike can cover the second one. So RINVOQ clearly has started to ramp in a fairly significant way. I think it's associated with 2 things. One is any time you see a pro -- it's about 8 months into its launch, you typically start to see that inflection point on successful products. As you go out and you present the data to physicians and start to educate physicians and they start to get some use, you tend to see that inflection point start to happen around 6 months. So I think it's the natural inflection point that we would have expected if the product was being successfully accepted into the marketplace the way we hoped as a high-efficacy agent. I think there is some benefit that we're seeing during the COVID crisis that it is an oral, so it's a little easier to prescribe than an injectable might be. So we're probably getting some collateral benefit associated with that. But I don't think that's the fundamental benefit that we're seeing. Mike?

    好的。謝謝。我來回答第一個問題。麥克可以負責第二個。因此,RINVOQ 顯然已經開始以相當顯著的方式發展。我認為這與兩件事有關。一是任何時候你看到一個專業人士——大約在產品推出 8 個月後,你通常會開始看到成功產品的轉捩點。當你出去將數據呈現給醫生並開始教育醫生並且他們開始使用時,你往往會看到拐點開始出現在 6 個月左右。因此我認為,如果該產品能夠像我們所希望的那樣,作為高效藥物成功進入市場,那麼這就是我們所期望的自然轉折點。我認為,我們在新冠肺炎危機期間看到了口服藥物的一些好處,因此比注射藥物更容易開處方。因此我們可能會獲得與此相關的一些附帶利益。但我不認為這是我們所看到的根本好處。麥克風?

  • Michael E. Severino - Vice Chairman & President

    Michael E. Severino - Vice Chairman & President

  • Right. So I'll take the question with respect to VENCLEXTA in solid tumors. I think there's 2 different lines of evidence. In breast cancer, there are -- there is an investigator-sponsored study that showed promise in breast cancer. And so there's a follow-up study there to confirm that. And if that were confirmed, it would be obviously a substantial opportunity, given the unmet need there. And then there are other solid tumors, such as both small cell lung cancer and non-small cell lung cancer, where there's preclinical rationale that warrants exploration. And so I would characterize the solid tumor program as higher risk but high reward, worthy of exploration. The solid tumor program in VENCLEXTA has not been baked into our thinking and isn't necessary for any of the success that we have talked about with the molecule. But if something were to hit there, represents very nice upside. And I think there's enough rationale to warrant the exploration.

    正確的。所以我想回答有關 VENCLEXTA 在實體腫瘤中的問題。我認為有兩種不同的證據。在乳癌方面,有一項由研究者發起的研究顯示了其在乳癌治療方面的前景。因此有一項後續研究來證實這一點。如果這一結論得到證實,那麼考慮到尚未滿足的需求,這顯然將是一個巨大的機會。還有其他實體腫瘤,例如小細胞肺癌和非小細胞肺癌,其臨床前原理值得探索。因此,我認為實體瘤計畫風險較高但回報較高,值得探索。 VENCLEXTA 中的實體腫瘤計畫尚未被納入我們的考慮範圍,而且對於我們談到的該分子的任何成功來說都不是必需的。但如果有東西攻擊那裡,那就代表著非常好的上行潛力。我認為有足夠的理由進行探索。

  • Elizabeth Shea - VP of IR

    Elizabeth Shea - VP of IR

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

    好的。謝謝。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。

  • Operator

    Operator

  • Thank you. This does conclude today's conference. You may disconnect at this time.

    謝謝。今天的會議到此結束。您現在可以斷開連線。