美國安進 (AMGN) 2020 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • My name is Erica, and I will be your conference facilitator today for Amgen's Second Quarter 2020 Financial Results Conference Call. (Operator Instructions) I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may begin.

    我叫艾莉卡,今天我將擔任安進公司 2020 年第二季財務業績電話會議的主持人。(操作員指示)現在我謹向大家介紹投資人關係副總裁 Arvind Sood。蘇德先生,你可以開始了。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Thank you, Erica. Good afternoon, everybody, and welcome to our Q2 call. This call is going to feel a bit different than our previous earnings calls because we are making some changes. As a matter of fact, in response to feedback from many of you that our prepared comments are too long, we are going to limit our prepared comments to around 20 minutes. We'll also limit the duration of the call to 1 hour. Now that doesn't mean that we are scaling back on disclosure. You'll notice our press release has been enriched to provide explanations that were previously included in our prepared comments. We think this approach will free up time for Q&A. But to make sure that everyone has an opportunity to ask a question, we are still going to request that you stick to asking only 1 question.

    謝謝你,艾麗卡。各位下午好,歡迎參加我們的第二季電話會議。由於我們做出了一些改變,這次的財報電話會議會和以往有所不同。事實上,鑑於許多人回饋我們準備的發言稿太長,我們將把發言稿的時長限制在 20 分鐘左右。我們也會將通話時間限制在 1 小時以內。但這並不意味著我們會減少資訊揭露。您會注意到,我們的新聞稿內容已進行擴充,加入了先前已包含在我們準備好的評論中的解釋。我們認為這種方法可以騰出時間來進行問答環節。但為了確保每個人都有機會提問,我們仍然要求您每次只提出一個問題。

  • The slides have been posted but will not match up to our prepared comments, given the brevity. Just a quick reminder that we'll use non-GAAP financial measures in our presentation and some of the statements will be forward-looking. Our 10-K and other filings identify factors that could cause our actual results to differ materially. So with that, I would like to turn the call over to Bob.

    投影片已經發布,但由於篇幅有限,與我們準備的發言內容並不完全一致。提醒一下,我們的簡報將使用非GAAP財務指標,其中一些陳述將具有前瞻性。我們的 10-K 和其他文件列出了可能導致我們的實際結果與預期結果有重大差異的因素。那麼,接下來我將把電話交給鮑伯。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Thank you, Arvind, and thank you, everyone, for joining today's call. As we look back at the first 6 months of the year and project forward to the second half, I'm very aware that we're still in the midst of a really significant global public health challenge and deep economic downturn. In that context, our results, which includes 6% revenues growth and driven by 13% volume growth. These are strong results, and they reflect the resilience of our people, strength of our operating systems and our success in continuing to supply every patient every time with the medicines they need.

    好的。謝謝 Arvind,也謝謝各位參加今天的電話會議。回顧今年前六個月並展望下半年,我非常清楚我們仍然處於非常重大的全球公共衛生挑戰和嚴重的經濟衰退之中。在此背景下,我們的業績包括 6% 的營收成長,其中銷量成長了 13%。這些都是非常出色的成績,體現了我們員工的韌性、我們營運系統的實力以及我們始終如一地為每位患者提供所需藥品的成功。

  • We remain confident in the long-term growth potential of innovative medicines like Otezla, Repatha, Prolia, EVENITY and Aimovig as well as our expanding portfolio of marketed biosimilars. Even in the second quarter, when we felt the depths of the pandemic, we delivered. Murdo will have more to say about that later and also about how we're navigating commercially through what remains a very dynamic week-by-week situation, especially in the U.S. and other parts of the world.

    我們對 Otezla、Repatha、Prolia、EVENITY 和 Aimovig 等創新藥物的長期成長潛力以及我們不斷擴大的上市生物相似藥產品組合仍然充滿信心。即使在第二季度,當我們感受到疫情最嚴峻的時刻,我們也實現了目標。Murdo 稍後會就此發表更多看法,也會談到我們如何在當前瞬息萬變的情況下進行商業決策,尤其是在美國和世界其他地區。

  • As we find new ways to meet the needs of current patients, we're excited about the potential of the medicines in our pipeline to enable us to serve many more patients in the future. We expect readouts in the second half of the year for sotorasib, which, of course, is our AMG 510 in non-small cell lung cancer; tezepelumab in severe asthma; and omecamtiv mecarbil in heart failure. Encouragingly, we've restarted many of the earlier-stage clinical trials that we put on hold due to COVID-19 at the end of the first quarter and beginning of the second. We're also exploring Otezla as a potential treatment for patients with COVID-19, and you'll hear Dave say more about that in a moment.

    隨著我們不斷探索滿足當前患者需求的新方法,我們對正在研發中的藥物的潛力感到興奮,這些藥物將使我們能夠在未來服務更多的患者。我們預計在今年下半年將公佈 sotorasib(當然,它是我們用於治療非小細胞肺癌的 AMG 510)、tezepelumab(用於治療重度氣喘)和 omecamtiv mecarbil(用於治療心臟衰竭)的試驗結果。令人鼓舞的是,我們已於第一季末和第二季初重新啟動了許多因 COVID-19 而暫停的早期臨床試驗。我們也在探索 Otezla 作為 COVID-19 患者的潛在治療方法,稍後您將聽到 Dave 對此做更多說明。

  • In an environment of ongoing uncertainty, our strong financial position provides us with competitive flexibility. And as Peter will discuss in a moment, our financial strength enables us to continue to invest in the long-term growth of our business internally and externally, while also returning capital to our shareholders.

    在當前充滿不確定性的環境下,我們雄厚的財務實力為我們提供了競爭優勢和靈活性。正如彼得稍後將要討論的那樣,我們的財務實力使我們能夠繼續投資於公司內部和外部的長期發展,同時也能為股東帶來回報。

  • We demonstrated tight control of expenses in the first half of the year. With health care systems operating more normally now, we expect to increase expenses, including for activities that were curtailed in parts of the first and second quarters.

    今年上半年,我們對各項開支進行了嚴格的控制。隨著醫療保健系統目前運作更加正常,我們預計支出將會增加,包括第一季和第二季部分活動所受到的限制。

  • We're in a strong position heading into the second half of the year, and I just want to take a moment to thank the Amgen staff all around the world in their steadfast support of our mission. I also want to express our profound appreciation for all our partners in the health care community for the support that they've shown to the patients that we're trying to serve together. Look forward to answering your questions later on our call. But right now, let me turn it over to Murdo.

    進入下半年,我們處於有利地位,我謹藉此機會感謝安進公司世界各地的員工對我們使命的堅定支持。我也要向醫療保健界的各位合作夥伴表達我們由衷的感謝,感謝他們對我們共同服務的病人所給予的支持。期待稍後在通話中回答您的問題。但現在,讓我把麥克風交給默多。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thank you, Bob. We continue to focus on growing volume across our diverse portfolio, while expanding our business geographically. Despite the challenges introduced by COVID-19, we executed effectively in Q2, growing year-over-year global revenues by 6%, with 13% from volume. Our U.S. business grew 7% with 14% from volume, and our ex U.S. business grew volume by 11%, posting nearly $1.5 billion in sales.

    謝謝你,鮑伯。我們將持續專注於提升多元化產品組合的銷售量,同時拓展業務的地理範圍。儘管面臨 COVID-19 帶來的挑戰,我們在第二季度仍有效執行了各項工作,全球營收年增 6%,其中銷量成長 13%。我們的美國業務成長了 7%,銷量成長了 14%;美國以外的業務銷量成長了 11%,銷售額接近 15 億美元。

  • As expected, during Q2, we experienced varying degrees of impact from COVID-19 across our portfolio. Exiting Q1 and through the first part of Q2, we saw interruptions to physician-patient interactions that led to delays in diagnosis and treatment. During the quarter, certain professional medical societies, such as NCCN and others, introduced treatment guidelines to assist in decision-making during the pandemic. Implementation of those guidelines had varying degrees of impact on prescribing for some of our products. For example, Prolia, which addresses an older, more vulnerable patient population and requires in-office administration, experienced greater negative impact early in the quarter.

    正如預期的那樣,在第二季度,我們的投資組合受到了 COVID-19 不同程度的影響。在第一季末和第二季初,我們看到醫患互動中斷,導致診斷和治療延誤。本季度,一些專業醫學協會,如 NCCN 等,推出了治療指南,以幫助在疫情期間做出決策。這些指導方針的實施對我們某些產品的處方產生了不同程度的影響。例如,Prolia 針對的是年齡較大、較脆弱的患者群體,並且需要在診室內進行管理,因此在本季度初受到了更大的負面影響。

  • In the case of Nplate, we saw a transition to competing oral alternatives as patients look to limit their visits to doctors' offices. XGEVA was also impacted by fewer patient visits and NCCN's recent recommendation to prioritize primary cancer treatments over bone-targeting agents. In contrast, Neulasta Onpro benefited during the quarter as it provides a convenient solution to help patients avoid additional visits to their site of care post chemotherapy. As physicians and patients learned more about ways to reduce the risk of COVID infections, and as local conditions improved in many countries and states, we saw some recovery during the second half of the quarter.

    以 Nplate 為例,我們看到,隨著患者希望減少去醫生診所的次數,人們開始轉向使用與之競爭的口服替代方案。XGEVA 也受到了患者就診次數減少以及 NCCN 最近建議優先考慮原發性癌症治療而非骨靶向藥物的影響。相比之下,Neulasta Onpro 在本季度受益,因為它提供了一種便捷的解決方案,可以幫助患者在化療後避免再次前往治療地點。隨著醫生和患者對降低 COVID 感染風險的方法有了更多了解,並且許多國家和地區的當地情況有所改善,我們在本季度後半段看到了一些復甦。

  • Let me just spend a few minutes discussing steps we've taken to provide continuity of care for patients during the pandemic. In bone health with Prolia, we implemented programs to address issues such as identifying alternate sites of care, mobile nurse-administered injections and prescription fills at specialty and retail pharmacies. Given Prolia's 6-month dosing schedule, we're keeping a close eye on further disruptions for the balance of 2020 and into 2021.

    請容許我花幾分鐘時間談談我們在疫情期間為患者提供持續照護所採取的措施。在 Prolia 的骨骼健康方面,我們實施了多項計劃,以解決諸如尋找替代護理地點、移動護士注射以及在專科藥房和零售藥房配藥等問題。鑑於 Prolia 的給藥週期為 6 個月,我們將密切關注 2020 年剩餘時間和 2021 年可能出現的進一步幹擾。

  • With EVENITY, we continue to see this product as a complementary growth opportunity with its unique bone-building profile and usage in high-risk post-fracture patients.

    我們繼續將 EVENITY 視為一種補充性的成長機會,因為它具有獨特的骨骼建構特性,並且適用於高風險骨折後患者。

  • Within cardiovascular, total Repatha prescriptions grew quarter-over-quarter, in part because of access and affordability improvements. We experienced a reduction in new prescriptions in April due to COVID-19, but saw improvements later in the quarter. While we're pleased with the new patient growth in Repatha, we're disappointed by CVS's decision to remove Repatha from its national formulary as of July 1, which will negatively impact total prescription growth in the third quarter. However, even with this formulary change, we continue to have segment-leading coverage in the PCSK9 class, with 75% of lives covered. And given the significant unmet medical need in treating high-risk cardiovascular patients, we remain very confident in our ability to grow Repatha.

    在心血管領域,Repatha 的總處方量較上季成長,部分原因是可近性和可負擔性增加。由於新冠疫情的影響,4 月新處方數量有所減少,但本季後期情況有所改善。雖然我們對 Repatha 的新患者成長感到高興,但我們對 CVS 決定從 7 月 1 日起將 Repatha 從其全國處方集中移除感到失望,這將對第三季度的總處方增長產生負面影響。然而,即使進行了此次藥品目錄變更,我們在 PCSK9 類藥物的覆蓋範圍仍然處於行業領先地位,覆蓋了 75% 的患者。鑑於在治療高風險心血管疾病患者方面存在巨大的未滿足醫療需求,我們對 Repatha 的發展能力仍然充滿信心。

  • Moving to inflammation portfolio, Otezla TRx growth remains strong in the quarter. Otezla grew in new-to-brand prescriptions and maintained a leading NBRx share, despite a decline in NBRx volume for the overall psoriasis market due to COVID-19. Otezla has proved to be a convenient option for patients due in part to its oral administration and lack of required lab monitoring. Otezla performance is tracking ahead of our original expectations in part due to exceptional integration.

    從發炎治療產品組合來看,Otezla TRx 在本季依然保持強勁成長。儘管受 COVID-19 疫情影響,銀屑病市場整體新藥處方量有所下降,但 Otezla 的新藥處方量卻有所增長,並保持了領先的新藥處方份額。由於 Otezla 可口服給藥且無需實驗室監測,因此已被證明是患者的一種便捷選擇。Otezla 的業績超出了我們最初的預期,部分原因是其卓越的整合能力。

  • With Enbrel, the pace of growth in the RA market slowed this quarter, causing a greater decline in overall market unit volume than past quarters. Consistent with prior results, we anticipate volume and net price trends for Enbrel to continue through 2020. Enbrel is a cornerstone of our inflammation therapeutic area, behind which we continue to invest, especially given the reaffirmation of Enbrel's intellectual property. We also continue to find promotional synergies across our inflammation portfolio of Otezla, Enbrel, AMGEVITA and recently launched AVSOLA, our biosimilar to infliximab.

    受恩利(Enbrel)的影響,本季類風濕關節炎(RA)市場的成長速度放緩,導致整體市場單位銷售量比過去幾季下降幅度更大。與以往的結果一致,我們預期 Enbrel 的銷售和淨價趨勢將在 2020 年持續維持。Enbrel 是我們發炎治療領域的基石,我們將繼續加大投入,尤其是在 Enbrel 的智慧財產權得到重申之後。我們也繼續在我們的發炎產品組合 Otezla、Enbrel、AMGEVITA 以及最近推出的 AVSOLA(我們的英夫利西單抗生物相似藥)中尋找推廣協同效應。

  • Moving to our biosimilar products. They generated $357 million in sales in Q2. As a reminder, these products are promoted by the same teams as our branded products, making for an efficient commercial model. As we talk with customers, they increasingly recognize the value proposition of Amgen's biosimilars, given their high quality, reliable supply and cost savings they provide.

    轉向我們的生物相似藥產品。第二季度,他們的銷售額為 3.57 億美元。再次提醒,這些產品由與我們的品牌產品相同的團隊進行推廣,從而形成了高效的商業模式。在與客戶的溝通中,他們越來越意識到安進生物類似藥的價值主張,因為它們品質高、供應可靠,還能節省成本。

  • In late Q1 and early Q2, social distancing measures also led to medical distancing. Looking ahead, we see a different pattern in the second half of 2020. While social distancing remains a critical behavior to minimize the risk of COVID infection, we see providers and payers encouraging patients to stay in touch with their doctors and to continue to seek medical care, either by telemedicine or through in-person appointments.

    第一季末和第二季初,保持社交距離的措施也導致了保持醫療距離。展望未來,我們看到2020年下半年將呈現不同的模式。雖然保持社交距離仍然是最大限度降低 COVID 感染風險的關鍵行為,但我們看到醫療服務提供者和支付方鼓勵患者與醫生保持聯繫,並繼續尋求醫療服務,無論是透過遠距醫療還是親自就診。

  • While certain parts of the U.S. and other countries have observed an increase in COVID-19 infections, our conversation with customers indicates that they are better prepared to handle spikes in cases as compared to 4 months ago. We continue to be vigilant and watch the spread of the virus as additional patient care disruptions could occur.

    雖然美國部分地區和其他一些國家的 COVID-19 感染病例有所增加,但我們與客戶的交流表明,與 4 個月前相比,他們現在更有能力應對病例激增的情況。我們將繼續保持警惕,並密切關注病毒的傳播,因為這可能會對患者的照護造成進一步的影響。

  • I am very appreciative of the hard work of Amgen employees through these challenging times. We remain focused on ensuring continuity of care for patients, including executing on investments in the second half of 2020 to drive growth of our markets and products, continue our geographic expansion and prepare for potential new product launches. And with that, I'll turn it over to Dave Reese.

    我非常感謝安進員工在這些充滿挑戰的時期所付出的辛勤努力。我們將繼續專注於確保患者護理的連續性,包括在 2020 年下半年執行投資,以推動市場和產品的成長,繼續我們的地域擴張,並為潛在的新產品上市做好準備。接下來,我將把麥克風交給戴夫‧里斯。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Thanks, Murdo. Good afternoon, everyone. I'll begin with an update on our clinical trial execution as we look forward to important data sets in the second half of 2020. Enrollment in our clinical studies has rebounded in recent weeks, and we have resumed enrollment to most of the studies that we paused due to COVID-19. Going forward, we expect to make additional investments in the second half of the year as enrollment increases in our clinical studies and work in our research labs approaches pre-COVID levels. We're also putting in place strategies to mitigate the uncertainties in clinical research created by any potential regional outbreaks of COVID-19.

    謝謝你,默多。大家下午好。首先,我將報告我們的臨床試驗執行情況,我們期待在 2020 年下半年獲得重要的資料集。最近幾週,我們的臨床研究入組人數有所回升,我們已經恢復了因 COVID-19 而暫停的大部分研究的入組工作。展望未來,隨著臨床研究的參與人數增加,以及研究實驗室的工作量接近新冠疫情前的水平,我們預計將在今年下半年進行更多投資。我們也在製定策略,以減輕 COVID-19 可能在區域內爆發所帶來的臨床研究的不確定性。

  • Importantly, our pivotal studies for sotorasib, tezepelumab and omecamtiv mecarbil remain on track, and we continue to expect high-quality data sets from these trials later in the year. We have also initiated new trials, including the sotorasib Phase III lung cancer study and several sotorasib Phase I combination cohorts. Finally, we continue to make progress with our half-life extended BiTE programs, and as previously communicated, anticipate sharing initial data for AMG 701 targeting BCMA; AMG 757 targeting DLL3 at meetings in the second half of 2020.

    重要的是,我們對 sotorasib、tezepelumab 和 omecamtiv mecarbil 的關鍵性研究仍在按計劃進行,我們繼續期待在今年稍後獲得這些試驗的高品質數據集。我們也啟動了新的試驗,包括 sotorasib III 期肺癌研究和幾個 sotorasib I 期聯合治療隊列研究。最後,我們繼續推進延長半衰期的 BiTE 項目,並如先前所溝通的那樣,預計將在 2020 年下半年的會議上分享針對 BCMA 的 AMG 701 和針對 DLL3 的 AMG 757 的初步數據。

  • Initial data from the AMG 160 program targeting prostate-specific membrane antigen, or PSMA, will be presented at the virtual ESMO meeting in September. We will be presenting an update on our sotorasib Phase I non-small cell lung cancer cohort, including initial biomarker data at ESMO as well.

    針對前列腺特異性膜抗原(PSMA)的 AMG 160 項目的初步數據將於 9 月在虛擬 ESMO 會議上公佈。我們將在 ESMO 上介紹 sotorasib I 期非小細胞肺癌隊列的最新進展,包括初步生物標記數據。

  • In our mid-stage pipeline, based on encouraging Phase I data in patients with elevated Lp(a), AMG 890 or short interfering RNA or siRNA has now entered Phase II development. In inflammation, with AstraZeneca, we made a strategic decision to discontinue the Phase II trial of tezepelumab in atopic dermatitis after reviewing the 16-week top line data. No new safety signals were observed, and this decision has no impact on the ongoing studies in asthma and COPD.

    在我們的中期研發管線中,基於 Lp(a) 水平升高患者的令人鼓舞的 I 期數據,AMG 890 或短幹擾 RNA 或 siRNA 現已進入 II 期開發階段。在發炎領域,我們與阿斯特捷利康合作,在審查了 16 週的主要數據後,做出了停止 tezepelumab 治療異位性皮膚炎的 II 期試驗的戰略決定。沒有觀察到新的安全訊號,該決定對正在進行的氣喘和慢性阻塞性肺病研究沒有影響。

  • Let me conclude by saying a few words about our efforts against COVID-19. We are investigating Otezla in multiple platform trials as a potential immunomodulatory treatment in patients hospitalized with viral infection, and the first of these studies should be announced in the coming days. In our pursuit of therapeutic antibodies, we are taking an orthogonal approach by focusing our efforts on the development of antibodies against targets other than the SARS-CoV-2 receptor binding domain, the RBD. The goal here being to develop an antibody complementary to the first generation therapies.

    最後,我想簡單談談我們對抗新冠肺炎疫情的努力。我們正在多個平台試驗中研究 Otezla 作為病毒感染住院患者的潛在免疫調節療法,其中第一項研究結果應該會在未來幾天內公佈。在研發治療性抗體的過程中,我們採取了一種正交的方法,將精力集中在開發針對 SARS-CoV-2 受體結合域 (RBD) 以外的標靶的抗體上。此處的目的是開發一種與第一代療法互補的抗體。

  • I'll be happy to discuss these or any other topics further in the Q&A session. Before I hand off to Peter, I'd like to thank all of our staff for continuing to deliver for patients during a difficult and important time. Peter?

    我很樂意在問答環節進一步討論這些或其他任何主題。在將發言權交給彼得之前,我想感謝我們所有的員工,感謝他們在這樣一個艱難而重要的時期繼續為病人提供服務。彼得?

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • Thank you, Dave. Good afternoon. Hope everyone is healthy and safe. Let's turn to the business. Our confidence in the growth potential of our business remains strong. This is exemplified by our solid execution in the second quarter. You will find our detailed Q2 results in the press release.

    謝謝你,戴夫。午安.希望大家都健康平安。讓我們進入正題。我們對公司的發展潛力依然充滿信心。第二季我們穩健的執行力就充分體現了這一點。您可以在新聞稿中找到我們第二季的詳細業績報告。

  • Let me provide some summary comments on how I view the quarter. On a year-over-year basis, we delivered 6% revenue growth and 7% non-GAAP EPS growth during the second quarter in a challenging environment. We are particularly pleased with revenue growth, driven largely by unit volume increases in Otezla, biosimilars, EVENITY and Repatha.

    讓我就我對本季的看法做一些總結性評論。在充滿挑戰的環境下,我們第二季實現了年比 6% 的營收成長和 7% 的非 GAAP 每股盈餘成長。我們對營收成長尤其感到滿意,這主要得益於 Otezla、生物相似藥、EVENITY 和 Repatha 的銷售成長。

  • Operating expenses increased 2% year-over-year as we continue to invest to drive growth, while recognizing COVID-19-related expense slowdowns. These slowdowns were pronounced in the second quarter, including a slowing of clinical trial activity. However, we exited the second quarter with an acceleration of activity as most trials were initiating clinical sites and enrolling patients.

    由於我們持續投資以推動成長,同時考慮到與 COVID-19 相關的支出放緩,營運支出較去年同期成長 2%。第二季這些放緩趨勢尤其明顯,包括臨床試驗活動的放緩。然而,隨著大多數試驗啟動臨床試驗點並招募患者,我們在第二季末加快了活動步伐。

  • Overall, we expect to increase investment in the second half of the year.

    總體而言,我們預計下半年將增加投資。

  • We have a strong balance sheet and cash position. This position was further strengthened in the second quarter with free cash flow of $2.7 billion and our debt issuance of $4 billion at attractive rates. Our capital allocation principles and plans remain unchanged and uninterrupted. Investment in both internal and external innovation remains the cornerstone of our long-term growth.

    我們擁有穩健的資產負債表和充裕的現金流。第二季度,該公司自由現金流達到 27 億美元,並以優惠利率發行了 40 億美元的債券,進一步鞏固了這一地位。我們的資本配置原則和計畫保持不變,不會中斷。對內部和外部創新的投入仍然是我們長期發展的基石。

  • Earlier this month, we announced an additional $421 million of investment in BeiGene, reflecting our confidence in our ongoing collaboration with them. Further underscoring our confidence in generating free cash flow, we continue to return capital to shareholders through both growing dividends and opportunistic share repurchases.

    本月初,我們宣布向百濟神州追加投資 4.21 億美元,這體現了我們對與百濟神州持續合作的信心。為了進一步彰顯我們對創造自由現金流的信心,我們將繼續透過提高股利和擇機回購股票的方式向股東返還資本。

  • Let me now share some thoughts on our outlook going forward. We experienced a negative impact from COVID-19 on our sales early in the second quarter, but began to see a general recovery in the second half of the quarter. The more recent resurgence of COVID-19 infection in parts of the United States and certain other countries creates significant uncertainty, both in the magnitude and the specific timing of the recovery. This could cause fluctuation in our quarterly revenues and earnings over the duration of the pandemic.

    現在我想和大家分享我對未來發展的一些看法。第二季初,新冠疫情對我們的銷售額產生了負面影響,但在第二季後半段開始出現整體復甦。美國部分地區和其他一些國家近期新冠疫情的再次爆發,為疫情的規模和恢復的具體時間都帶來了極大的不確定性。這可能會導致我們在疫情期間季度收入和利潤出現波動。

  • Despite this uncertainty, we are reaffirming our revenue guidance of $25.0 billion to $25.6 billion. We are updating our non-GAAP earnings per share guidance to $15.10 to $15.75 versus prior guidance of $14.85 to $15.60. This reflects our confidence in our underlying business continuing to deliver for patients.

    儘管存在這種不確定性,我們仍重申營收預期為 250 億美元至 256 億美元。我們將非GAAP每股盈餘預期從先前的14.85美元至15.60美元調整為15.10美元至15.75美元。這體現了我們對公司核心業務能夠持續為患者提供優質服務的信心。

  • For the full year, we continue to expect total non-GAAP operating expenses to grow in the high-single-digit percentage range year-over-year with the breakdown as follows: cost of sales as a percent of product sales to be generally consistent with 2019; in R&D, we plan to increase investments in the second half of the year, including in our innovative pipeline and as clinical trial and lab activity accelerate; SG&A spend is projected to increase primarily due to Otezla, geographic expansion and launch preparations for our late-stage pipeline.

    全年來看,我們仍然預期非GAAP營運總支出將同比增長,增幅在個位數百分比範圍內,具體構成如下:銷售成本佔產品銷售額的百分比將與2019年基本持平;研發方面,我們計劃在下半年增加投資,包括對創新產品線的投資,以及隨著臨床試驗和實驗室活動的加速產品;預計

  • I would reemphasize that we expect operating expenses to meaningfully increase in the second half of the year as the recovery continues. This increase reflects, first, investments in our pipeline as well as launch preparations. And secondly, the typical historical spend pattern for our business.

    我想再次強調,隨著經濟復甦的持續,我們預計下半年營運費用將大幅增加。這一成長首先反映了我們對產品線的投資以及上市準備。其次,是我們公司典型的歷史支出模式。

  • We anticipate non-GAAP other income and expense to be a net expense of about $1.4 billion. We continue to expect share repurchases at an amount at the lower end of our previously disclosed range of $3 billion to $5 billion. And I, too, would like to thank all of my colleagues around the world for their commitment to the Amgen difference to patients. This concludes the financial update.

    我們預計非GAAP其他收入和支出淨額約為14億美元。我們仍然預期股票回購金額將處於我們先前披露的 30 億美元至 50 億美元範圍的下限。我也要感謝世界各地的同事們,感謝他們對安進為病人帶來卓越療效的承諾。財務更新到此結束。

  • I'll turn it back to Bob to get to our Q&A.

    我將把麥克風交還給鮑勃,讓他進入問答環節。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Okay. Erica, can you remind our callers of the procedures for asking their questions?

    好的。艾莉卡,你能提醒一下來電者提問的流程嗎?

  • Operator

    Operator

  • (Operator Instructions) And your first question is from Evan Seigerman with Crédit Suisse.

    (操作說明)您的第一個問題來自瑞士信貸的 Evan Seigerman。

  • Evan David Seigerman - VP & Senior Equity Research Analyst

    Evan David Seigerman - VP & Senior Equity Research Analyst

  • And I appreciate the new format of the call. So I'm looking at the -- I'm curious on the tezepelumab Phase II atopic dermatitis data. Did you see any signal in this trial? And more importantly, is there any read-through to the Phase III asthma trial expected later this year?

    我很喜歡這種新的通話形式。所以我正在查看——我對tezepelumab II期異位性皮膚炎的數據很感興趣。你在這次試驗中看到任何訊號了嗎?更重要的是,今年稍後即將進行的 III 期氣喘試驗的結果是否有任何參考價值?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Thanks, Evan, this is Dave. I'll take that question. While there was some evidence of activity on some disease measures, we just have top line data right now. We've got a number of additional analyses, including biomarker analyses to do. Importantly, I really don't think there's much read-through at all to asthma and, in fact, the best insights that we have into the activity of the drug in asthma are the large Phase II study that we previously conducted in asthma across the range of patients with both eosinophil high and eosinophil low forms of the disease. So we're on track, as I mentioned, for the readout of those data, and this doesn't really change our point of view on asthma.

    謝謝你,埃文,我是戴夫。我來回答這個問題。雖然一些疾病指標顯示出一定的活動跡象,但目前我們只有整體數據。我們還有一些其他的分析工作要做,包括生物標記分析。重要的是,我真的不認為氣喘能從中得到太多啟示,事實上,我們對該藥物在氣喘中的活性所了解的最好見解,是我們之前在氣喘患者中開展的大型 II 期研究,該研究涵蓋了嗜酸性粒細胞高表達型和嗜酸性粒細胞低表達型氣喘患者。正如我之前提到的,我們正按計劃推進這些數據的解讀,但這並不會真正改變我們對氣喘的看法。

  • Operator

    Operator

  • Your next question is from Yaron Werber with Cowen.

    下一個問題來自 Cowen 公司的 Yaron Werber。

  • Yaron Benjamin Werber - MD & Senior Biotechnology Analyst

    Yaron Benjamin Werber - MD & Senior Biotechnology Analyst

  • Great. I have maybe a quick question on biosimilars. And again, you continue to really capture a lot of share. You're sort of in the 30s already with MVASI and KANJINTI. You've had some destocking, and now it sounds like you obviously are continuing to expect some competition coming in. So I want to know, give us a sense kind of, if you can, where are you sitting with inventories? And how much competition or how impactful of a competition do you think will be given that you're capturing share? And how quickly would AVSOLA really be a meaningful contributor?

    偉大的。我可能有個關於生物相似藥的小問題。再次強調,你們繼續佔據了很大的市場。你已經和 MVASI 和 KANJINTI 一起達到了 30 多歲了。你們已經進行了一些清倉,現在看來你們顯然還在期待一些競爭的到來。所以我想知道,如果可以的話,請您大致介紹一下,您目前的庫存狀況如何?鑑於你們正在搶佔市場份額,你認為競爭會有多激烈,或者說競爭的影響會有多大?AVSOLA究竟要多久才能真正發揮重要作用?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Yaron, it's Murdo. We are very pleased with the performance of the biosimilar portfolio and, specifically, the 2 that you highlighted, MVASI and KANJINTI, which, quite frankly, in the period of time that's been disrupted by COVID. I think providers are looking for a lot of places where they can extract more value in the health care system, so we've been pleased with the uptake. As you mentioned, we're in the high 30s with MVASI, mid-30s with KANJINTI, and we don't see those trends slowing right now given competition. So that's the first comment I would make.

    是的。謝謝,亞倫,我是默多。我們對生物相似藥產品組合的表現非常滿意,特別是您重點提到的兩款產品 MVASI 和 KANJINTI,坦白說,在 COVID 疫情造成的這段時間裡,它們的表現尤其令人滿意。我認為醫療服務提供者正在尋找許多能夠從醫療保健系統中獲得更多價值的地方,因此我們對目前的接受度感到滿意。正如您所提到的,MVASI 的銷量已經接近 30%,KANJINTI 的銷量也達到了 30 多,考慮到目前的競爭形勢,我們認為這些趨勢不會放緩。這是我的第一條評論。

  • And overall inventories, there's been no real build there over the last few weeks. So we continue to see normal inventory levels in the biosimilars market. I would say, to your point on competitive dynamics overall, as more entrants come into the market, I would say we're less challenged on share, but you might see some net price effects of multiple competitors entering.

    總體而言,過去幾週庫存並沒有真正增加。因此,我們看到生物相似藥市場庫存水準繼續保持正常水準。關於您提到的整體競爭動態,我認為隨著更多競爭者進入市場,我們在市場份額方面面臨的挑戰會減少,但您可能會看到多個競爭對手進入市場對淨價格產生一些影響。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Murdo, do you want to touch on AVSOLA, which was one of the other questions Yaron asked.

    Murdo,你想談談AVSOLA嗎?這是Yaron提出的另一個問題。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks for the prompt, Bob. Yes, we're pleased. We just recently launched AVSOLA at the beginning of July, our biosimilar to infliximab. It's early days, so I don't really have any performance metrics to provide with you. It is a nice addition to our strong inflammation portfolio with Enbrel, Otezla, AVSOLA and soon some other biosimilars as well, as hopefully, tezepelumab, so really strengthening our portfolio overall.

    謝謝你的及時回复,鮑伯。是的,我們很高興。我們在 7 月初剛推出了 AVSOLA,這是我們的英夫利西單抗生物相似藥。現在還處於早期階段,所以我目前還沒有任何績效指標可以提供給您。它很好地補充了我們強大的發炎產品組合,其中包括 Enbrel、Otezla、AVSOLA,而且很快還會有其他一些生物類似藥,希望還能有 tezepelumab,因此真的能全面加強我們的產品組合。

  • We are a little late on this one. So we're going to see how we do in the market versus the existing competitors, but we have a strong team there. And just like we did with oncology, where we use our innovative field force who have existing relationships with providers to commercialize our biosimilars, we're doing the same thing in inflammation.

    我們在這件事上稍微晚了一點。所以我們將看看我們在市場上與現有競爭對手相比表現如何,但我們擁有一支強大的團隊。就像我們在腫瘤領域所做的那樣,我們利用與醫療服務提供者建立現有關係的創新銷售團隊來推廣我們的生物相似藥,我們在發炎領域也正在做同樣的事情。

  • Operator

    Operator

  • Your next question is from Jay Olson with Oppenheimer.

    下一個問題來自奧本海默公司的傑伊·奧爾森。

  • Jay Olson - Executive Director & Senior Analyst

    Jay Olson - Executive Director & Senior Analyst

  • Congratulations on an impressive quarter during difficult times. I'm curious about the comments you made regarding mobile administration of Prolia. Is that a temporary strategy to navigate the pandemic? Or is that something you consider more of a permanent arrangement? And if so, would you also consider providing home infusion for other Amgen drugs besides Prolia?

    恭喜你們在如此艱難的時期取得了令人矚目的季度業績。我對您之前關於Prolia行動端管理的評論很感興趣。這是應對疫情的臨時策略嗎?或者您認為這是一種更長期的安排?如果可以的話,除了Prolia之外,您是否也會考慮為安進的其他藥物提供家庭輸液服務?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks for the question, Jay. The Prolia story is one that I'm really thankful for. That team mobilized very quickly around the world, wasn't just in the U.S. Prolia is, in many markets, actually a hospital-administered product. And if I can use Italy as an example, we actually were able to do home delivery of Prolia for Italian patients, if you recall, with the spike that they had with COVID in Northern Italy.

    謝謝你的提問,傑伊。我真的很感激Prolia的故事。該團隊迅速在全球範圍內動員起來,不僅限於美國。在許多市場,Prolia 實際上是一種由醫院管理的藥物。如果以義大利為例,我們當時確實能夠為義大利患者提供 Prolia 的送貨上門服務,如果你還記得的話,當時義大利北部 COVID 病例激增。

  • In the U.S., we worked closely actually with CMS and even the FDA to ensure that we were appropriately opening up alternate sites of care for Prolia patients. And we were successful in securing this mobile nurse platform that you alluded to. We also actually opened up the possibility of home infusion or injection in this case with Prolia and, potentially, even self-administration. We've developed, with input from the FDA, a self-administration kit.

    在美國,我們與 CMS 甚至 FDA 密切合作,以確保我們為 Prolia 患者適當地開設替代護理場所。我們成功獲得了您提到的那個行動護理師平台。在這種情況下,我們實際上也開啟了使用 Prolia 進行居家輸液或註射的可能性,甚至有可能實現自我給藥。我們在FDA的指導下開發了一種自我給藥套裝。

  • I would say it this way, I would say the vast majority of Prolia administrations are still in-office and continue to be as long as we have relatively open access to physician practices and physicians have evolved and are adapting to COVID by helping create safe waiting rooms and safe care environment for patients.

    我會這樣說,我認為絕大多數的普羅利亞政府仍然在位,並且只要我們能夠相對開放地接觸醫生,醫生們也已經發展並適應了新冠疫情,幫助為患者創造安全的候診室和安全的護理環境,那麼這些政府就會繼續運作下去。

  • However, should there be additional spikes in COVID or additional disruption to that patient care, we believe we've opened up other channels that we feel good about in helping patients have continuity of care.

    但是,如果新冠疫情再次出現高峰,或者患者護理再次受到干擾,我們相信我們已經開闢了其他管道,我們對此感到滿意,這些管道可以幫助患者獲得持續的護理。

  • And as to the long-term possibility of this, I think, look, we see a lot of innovations during COVID that could persist. There are definitely some reimbursement mechanisms with Prolia being a Part B product that make that a little more difficult. But with time and experience, we'll know more on how to continue to make Prolia available to patients.

    至於這種做法的長期可能性,我認為,你看,我們在新冠疫情期間看到了許多創新,這些創新可能會持續下去。由於 Prolia 屬於 B 部分產品,因此其報銷機制肯定會使報銷變得更加困難。但隨著時間和經驗的積累,我們會更了解如何繼續為患者提供 Prolia。

  • Operator

    Operator

  • Your next question is from Terence Flynn with Goldman Sachs.

    下一個問題來自高盛的 Terence Flynn。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • Dave, I was just wondering as you think about your BiTE platform here, is your confidence level in the platform the same in terms of the heme indications versus the solid tumor indications? Just wanted to kind of get a sense from you. I know you've made some comments before about solid tumor activity, but just curious on kind of how you view that lately.

    Dave,我只是想問,你對你的 BiTE 平台有什麼看法?你對該平台在血液腫瘤適應症和實體腫瘤適應症的信心程度是否相同?我只是想了解你的想法。我知道你之前發表過一些關於實體瘤活動性的評論,但我只是好奇你最近對此有何看法。

  • And then can you just remind us of the design of the 160 Phase I study that's going to be at ESMO, and maybe what you're hoping to see to advance into Phase II?

    那麼,您能否簡要介紹即將在 ESMO 會議上公佈的 160 例 I 期研究的設計,以及您希望看到哪些結果推進到 II 期?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. Thanks for the question. As I mentioned, we're going to be presenting at ESMO the 160 data. We've got 2 of the BiTE programs moving along in solid tumors, that one and the program targeting DLL3 in small cell lung cancer. Both of those are in dose escalation, so you're going to see the initial dose escalation from 160 at ESMO.

    是的。謝謝你的提問。正如我之前提到的,我們將在 ESMO 上展示這 160 項數據。我們有 2 個 BiTE 計畫正在實體瘤領域推進,一個是針對小細胞肺癌中 DLL3 的計畫。這兩種藥物都在進行劑量遞增試驗,所以你將在 ESMO 會議上看到初始劑量從 160 開始遞增。

  • I would say we're seeing interesting hints of activity. You'll get a look at those data as we move forward. It's still early days, and we're still dose ranging. But I think we remain confident in the half-life extended BiTE platform, and we're looking forward to pushing those studies through dose escalation.

    我認為我們看到了一些有趣的活動跡象。隨著我們接下來的進展,您將會看到這些數據。現在還處於早期階段,我們仍在進行劑量範圍的探索。但我認為我們仍然對半衰期延長的 BiTE 平台充滿信心,我們期待著推進這些研究,進行劑量遞增。

  • Operator

    Operator

  • Your next question is from Geoff Meacham with Bank of America.

    下一個問題來自美國銀行的傑夫‧米查姆。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • Bob, I wanted to get your thoughts on the drug pricing and other executive orders. I didn't hear much about it in the prepared remarks. And so the question is would you expect implementation in its current form? And as written, where would you imagine would be the greatest exposure relative to the Amgen portfolio?

    鮑勃,我想聽聽你對藥品定價和其他行政命令的看法。我在準備好的發言稿中並沒有聽到太多關於這方面的內容。所以問題是,您是否期望它以目前的形式實現?根據目前的陳述,您認為相對於安進的投資組合而言,風險敞口最大的領域在哪裡?

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • Geoff, I would just say it's early days still. We're looking forward to seeing the actual language behind these executive orders. And we're pleased that one of the executive orders addresses the rebate mechanism. And we're very focused on, as you know, our view is the nation needs more innovation, not less. And the nation needs to have less innovations sitting stock on pharmacy shelves and making its way to patients. And one way to do that is to try to bring down the out-of-pocket cost for, in particular, seniors at the pharmacy. And we think the rebate rule, the executive order, as we understand it anyway, opens the door for that. So that feels constructive.

    傑夫,我只想說現在下結論還太早。我們期待看到這些行政命令的原文。我們很高興其中一項行政命令涉及退款機制。如您所知,我們非常關注的是,我們認為國家需要更多創新,而不是更少創新。國家需要減少藥局貨架上積壓的創新藥品,讓它們能夠盡快送到患者手中。其中一個方法是努力降低老年人在藥局的自付費用。我們認為,退稅規則,也就是我們所理解的行政命令,為這種情況打開了方便之門。感覺這樣挺有建設性的。

  • Obviously, there's a lot of focus as well, Geoff, on this most favored nation or IPI-like executive order. But as far as I'm aware, the language on that is not available yet. And obviously, for us and I think for all the innovators in our industry, the idea of importing prices from socialized medicine countries where there are all kinds of other access problems for innovative medicines like ours, unlike those which U.S. citizens have access to, we think, is problematic.

    顯然,傑夫,人們也非常關注這項最惠國待遇或類似國際保護倡議的行政命令。但據我所知,目前還沒有相關的語言版本。顯然,對於我們以及我認為對於我們行業的所有創新者來說,從實行社會化醫療的國家引進價格,而這些國家在獲取像我們這樣的創新藥物方面存在各種各樣的其他問題,這與美國公民能夠獲得的藥物不同,我們認為這是有問題的。

  • Now the good news for seniors in the United States is virtually all the innovative cancer medicines that you ask us about and that we're so excited about are available to our citizens. And it's a very different picture in other parts of the world, including other parts of the world that that order might reference. So we will watch with concern, but we think there are better ways to address the issue than that approach. So stay tuned. I'm sure there'll be more information on it as time passes.

    現在,對於美國的老年人來說,好消息是,你們詢問的、我們非常興奮的幾乎所有創新癌症藥物,我們的公民都可以獲得。世界其他地區的情況則截然不同,包括該命令可能提及的其他地區。所以我們會密切關注,但我們認為解決這個問題有比這種方法更好的方法。敬請期待。我相信隨著時間的推移,會有更多相關資訊公佈。

  • Operator

    Operator

  • Your next question is from Chris Raymond with Piper Sandler.

    下一個問題來自克里斯·雷蒙德和派珀·桑德勒。

  • Christopher Joseph Raymond - MD & Senior Research Analyst

    Christopher Joseph Raymond - MD & Senior Research Analyst

  • Just with regard to Aimovig. Some of our checks we've done recently indicate there's a pretty decent level of receptivity to oral CGRPs in the prevention setting once those options are labeled. Maybe, Murdo, maybe just sort of talk about your view of sort of the longevity of subcu CGRPs in general, and maybe Aimovig in particular, even when there's an oral option available in that setting.

    僅就Aimovig而言。我們最近進行的一些檢查表明,一旦口服 CGRP 被貼上標籤,人們在預防方面對這些藥物的接受度就相當高。或許,默多,或許可以談談你對皮下注射 CGRP 藥物的長期療效的看法,特別是 Aimovig 的療效,即使在這種情況下有口服藥物可供選擇。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks for the question, Chris. Yes. The overall, we have to just reflect on the huge unmet need with migraine here. We are barely penetrating roughly a 4 million incident patient population where there's a significant amount of usage of older medications that just do not provide the migraine relief that Aimovig can. And so far, we're pleased with the evolution of penetrating that unmet need with Aimovig and we're definitely very pleased with the impact we've had on patients' lives.

    謝謝你的提問,克里斯。是的。總而言之,我們必須反思偏頭痛領域巨大的未滿足需求。我們目前僅勉強滲透到約 400 萬新發偏頭痛患者群體中,而這些患者群體中很大一部分人仍在使用老藥,這些老藥無法像 Aimovig 那樣有效緩解偏頭痛。到目前為止,我們對 Aimovig 在滿足這一未被滿足的需求方面取得的進展感到滿意,並且我們對我們對患者生活產生的影響感到非常滿意。

  • What we're seeing so far with the oral agents is really they're used more as add-on treatment options given their current indications. And I think that's actually helping further strengthen Aimovig's perception in clinical experience for patients from neurologists. It will be interesting to see what the data look like on the prevention side and what labeling looks like as well.

    就目前來看,口服藥物更多是作為輔助治療方案使用,因為它們的適應症有限。我認為這實際上有助於進一步加強神經科醫生對 Aimovig 在臨床經驗方面的患者認知。預防方面的數據以及標籤情況將會很有趣。

  • But overall, I think there's a lot of room for more patients to benefit from a CGRP-based therapy. And we think we've got the one of the best, if not the best, given the convenient once-a-month injection, the really strong coverage that we now have across the U.S. in terms of insured benefit and great patient support programming to help patients, possibly even titrate up in their dosing on Aimovig. So I think a lot of growth yet to be realized even with additional entrants in the market.

    但總的來說,我認為基於 CGRP 的療法還能讓更多患者受益。我們認為,鑑於其每月一次的便捷注射、目前在美國擁有的強大的保險福利覆蓋範圍以及出色的患者支持計劃,我們擁有最好的產品之一,甚至可能是最好的,可以幫助患者逐步增加 Aimovig 的劑量。所以我認為,即使有更多企業進入市場,仍有很大的成長空間尚未實現。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. This is Dave. Chris, this is Dave. I would just add that, obviously, we'll be looking at long-term safety with the small molecules when you get to chronic administration. And we're very happy with the long-term safety profile now extending 4 years in some patients with Aimovig.

    是的。這是戴夫。克里斯,這是戴夫。我還要補充一點,顯然,在進行長期用藥時,我們會考慮小分子藥物的長期安全性。我們對 Aimovig 的長期安全性非常滿意,目前部分病患的用藥時間已延長至 4 年。

  • Operator

    Operator

  • Your next question is from Ronny Gal with Bernstein.

    下一個問題來自伯恩斯坦的羅尼·加爾。

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • Question is for David. First, if you don't mind clarifying, you kind of mentioned the tezepelumab data in atopic dermatitis. You haven't mentioned the safety side in the Phase II in asthma. You did see a case in Guillain-Barre, and I guess, stroke, and there's always a concern of anaphylaxis in this population. I was wondering if you could just clarify if we are seeing this signal repeating themselves in the atopic dermatitis trial.

    這個問題是問大衛的。首先,如果您不介意澄清一下,您剛才提到了 tezepelumab 在異位性皮膚炎方面的數據。您沒有提到氣喘二期臨床試驗中的安全性問題。你確實見過格林-巴利症候群的病例,我想還有中風,而且在這個人群中總是存在過敏性休克的擔憂。我想請您澄清一下,我們在異位性皮膚炎試驗中是否也看到了這種訊號。

  • And then on the mutualizing antibody strategy, is the strategy that you're having to find in antibodies which are complementary to the spike proteins is that coming instead of the previous strategy was to look for the high specificity antibody? Or is this an additional strategy?

    那麼,在互惠抗體策略中,您現在需要尋找與刺突蛋白互補的抗體,而不是像以前那樣尋找高特異性抗體嗎?或者,這是一種額外的策略?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. Thanks, Ronny. So in regard to the teze data, I would say there were no concerning safety signals at all in the Phase II atopic dermatitis trial. The Phase III trial, as is standard, has an independent data monitoring committee that, of course, periodically evaluates safety. And they have always indicated the trial should proceed as planned, and we fully expect that that will happen to completion over the coming few months.

    是的。謝謝你,羅尼。因此,就 Teze 數據而言,我認為在 II 期異位性皮膚炎試驗中完全沒有出現任何令人擔憂的安全訊號。按照慣例,III 期試驗設有一個獨立的資料監測委員會,該委員會當然會定期評估安全性。他們一直表示審判將按計劃進行,我們完全相信審判將在未來幾個月內完成。

  • In terms of our COVID-19 therapeutic antibody strategy, we -- as we have looked at the rapid evolution of the field, most of the antibodies, as I'm sure you're aware, that have gone into the clinic, target the RBD, receptor binding domain, of the spike protein. Our technical assessment of those antibodies is that some of them appear to be quite good. And our belief is that we could potentially add value here to the therapeutic armamentarium by developing an antibody, targeting another epitope, nonoverlapping, and that could potentially be added to an antibody or a cocktail from that first generation. So that is the strategy. We were open to that from the start, and we are now focusing on that, I would say, as we've watched the evolution of the field.

    就我們的 COVID-19 治療抗體策略而言,正如我們所看到的,該領域的快速發展表明,大多數已進入臨床的抗體,正如我相信您所知,都以刺突蛋白的受體結合域 (RBD) 為靶點。我們對這些抗體的技術評估是,其中一些似乎相當不錯。我們相信,透過開發一種針對另一個非重疊表位的抗體,我們可以為治療手段增添價值,這種抗體可以添加到第一代抗體或混合抗體中。這就是我們的策略。我們從一開始就對此持開放態度,可以說,隨著我們觀察該領域的發展,我們現在正專注於此。

  • Aaron Gal - Senior Research Analyst

    Aaron Gal - Senior Research Analyst

  • Care to share with us who's antibody you're particularly impressed with?

    您能否和我們分享一下,您對哪家公司的抗體印象最深刻?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • You know I'm not going to comment on that one. I'll leave you to assess that.

    你知道我不會對此事發表評論。這個問題就留給你來評估吧。

  • Operator

    Operator

  • Your next question is from Matthew Harrison with Morgan Stanley.

    下一個問題來自摩根士丹利的馬修·哈里森。

  • Matthew Kelsey Harrison - Executive Director

    Matthew Kelsey Harrison - Executive Director

  • Dave, I was hoping to ask about the IL-2 mutein program. It seems like you made a decision not to move ahead in RA, but there are obviously some GI indications that you and other companies are studying. Can you just talk a little bit about your excitement or lack thereof around those other indications, and any data you got from RA, which may influence the profile in those other indications?

    Dave,我原本想問關於IL-2突變體計畫的問題。看來您已經決定不再推進類風濕關節炎(RA)的研發,但顯然您和其他公司正在研究一些胃腸道(GI)方面的適應症。您能否談談您對其他適應症的興奮程度(或缺乏興奮程度),以及您從類風濕性關節炎中獲得的任何可能影響其他適應症特徵的數據?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes, Matt, thanks for the question. We remain quite interested in this molecule, which, again, to remind everyone, is designed to enhance the number and function of T regulatory cells and restore some of the dysregulation of the immune system that occurs in certain autoimmune diseases.

    是的,馬特,謝謝你的提問。我們仍然對這種分子非常感興趣,再次提醒大家,這種分子旨在增強 T 調節細胞的數量和功能,並恢復某些自體免疫疾病中發生的免疫系統失調。

  • We knew from the start that it's a high bar in rheumatoid arthritis, given existing therapies and based on the emerging data, elected not to go forward in that indication. I think there are a variety of other autoimmune diseases where this is of interest, and we're continuing to push that program forward. As we move towards additional trials, of course, we will share that with you. And we've got ongoing studies in diseases like lupus or where there remains a significant unmet medical need.

    從一開始我們就知道,鑑於現有的療法和新出現的數據,類風濕性關節炎的治療門檻很高,因此我們選擇不在該適應症上繼續前進。我認為這項研究對其他多種自體免疫疾病也很有意義,我們將繼續推進該計畫。當然,當我們進行更多試驗時,我們會與您分享相關資訊。我們目前正在進行一些疾病的研究,例如狼瘡,或其他仍存在重大未滿足醫療需求的疾病。

  • Operator

    Operator

  • Your next question is from Michael Yee with Jefferies.

    下一個問題來自傑富瑞集團的麥可葉。

  • Michael Jonathan Yee - Equity Analyst

    Michael Jonathan Yee - Equity Analyst

  • A question for David on omecamtiv mecarbil, of course, a big Phase III readout and has a unique mechanism and elegant science. Could you just put into context for us what maybe 1 or 2 things you specifically like from the prior data and what degree of confidence you have given a high bar for a CV outcomes study, clinical meaningful magnitude of benefit? Maybe just talk a little bit about that and how you uncap that. Appreciate it.

    當然,我有一個關於 omecamtiv mecarbil 的問題要問 David,它正在進行一項重要的 III 期臨床試驗,具有獨特的機制和精妙的科學原理。您能否為我們簡要介紹一下,您特別喜歡先前數據中的哪一兩點?您對心血管結果研究的高標準、臨床意義上的效益程度有多大的信心?或許可以稍微談談這件事,以及你是如何突破這個限制的。謝謝。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. Thanks, Mike. As you mentioned, there's -- it's a novel mechanism of action. It's the first drug that directly affects contractility of myocardial cells, and that's, of course, one of the primary dysfunctions in advanced heart failure. So that's obviously a priori, one of the things that we like about the molecule.

    是的。謝謝你,麥克。正如您所提到的,這是一種全新的作用機制。它是第一種直接影響心肌細胞收縮力的藥物,而心肌細胞收縮力當然是晚期心臟衰竭的主要功能障礙之一。所以這顯然是我們喜歡這個分子的原因之一。

  • In addition, I think the Phase II data, what caught our eye was the fact that there was internal consistency when you looked across physiologic measures, the various physiologic outcome measures that are used in mid-stage heart failure programs as well as various biomarkers. And to see that sort of internal consistency is another thing that gives you confidence. But I would point out that we're now doing the definitive experiment, a Phase III trial in over 8,000 patients. It's well powered. And there will be sufficient follow-up. And so I think we're going to know the answer as to the utility of omecamtiv mecarbil in advanced heart failure by the end of the year.

    此外,我認為第二階段的數據最吸引我們的是,當你查看生理指標、中期心臟衰竭計畫中使用的各種生理結果指標以及各種生物標記時,會發現其內部一致性。看到這種內部一致性,也會讓人更有信心。但我要指出的是,我們現在正在進行一項決定性的實驗,一項涉及 8000 多名患者的 III 期試驗。它動力強勁。後續會有充分的跟進。因此,我認為到今年年底,我們就能知道 omecamtiv mecarbil 在晚期心臟衰竭中的療效了。

  • Operator

    Operator

  • Your next question is from Robyn Karnauskas with SunTrust.

    下一個問題來自 SunTrust 的 Robyn Karnauskas。

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • So I guess 2 quick ones. What are the trends that you're seeing in the doctor's office as far as ease of reimbursement given the economic climate? Are you having to give more free drugs? And second question, given the environment, you talked about spending more in the back half of the year, what about your -- any changes or new thought on -- updated thoughts on your appetite for M&A or business development?

    所以我想應該是兩個簡短的問題。鑑於當前的經濟形勢,您在醫生診所觀察到的報銷便利性方面有哪些趨勢?你們是不是需要發放更多免費藥物?第二個問題,鑑於目前的情況,您提到下半年會增加支出,那麼您對併購或業務拓展的意願是否有任何變化或新的想法?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Okay. Robyn, why don't I start with the first -- Yes. I'll start with the first part of your question and turn it over to Bob for your second part of your question. Overall, we're actually pretty pleased with what we're seeing, particularly in the latter part of the second quarter in patients accessing reimbursements for their medications. We do have generous programs that we provide. But given the fairly significant expansion in Repatha, Aimovig and EVENITY coverage with a permanent J code, we really have seen less need for those programs currently. Now that could change in the longer term as some of the patients who are maybe currently furloughed could become displaced or laid off or as patients who may be securing COBRA could end up lapsing.

    好的。羅賓,我先從第一個開始吧——好的。我先回答你問題的第一部分,然後把第二部分交給鮑伯來回答。總的來說,我們對目前的情況相當滿意,尤其是在第二季後半段,病患獲得藥品報銷的情況。我們確實提供一些慷慨的福利項目。但鑑於 Repatha、Aimovig 和 EVENITY 的覆蓋範圍已大幅擴大,並獲得了永久 J 代碼,我們目前確實沒有看到對這些計劃的需求減少。從長遠來看,這種情況可能會發生變化,因為一些目前可能暫時停工的患者可能會失業或被解僱,或者一些可能獲得 COBRA 保險的患者最終可能會失去保險資格。

  • Also, many patients end up going off of their own benefits to a spousal benefit. So there's multiple layers of how people who are losing their insurance coverage might be able to bridge through different mechanisms. We're also hopeful and maybe even optimistic that some additional stimulus would be provided so that patients can seek continuity of their health care coverage. But overall, I would say, so far, so good, despite significant disruption, obviously, in our economy.

    此外,許多患者最終會放棄自己的醫療福利,轉而享受配偶福利。因此,失去保險保障的人們可以透過多種不同的機制來獲得幫助,這涉及多個層面。我們也希望,甚至樂觀地認為,政府會提出一些額外的刺激措施,以便患者能夠繼續獲得醫療保健服務。但總的來說,儘管我們的經濟顯然受到了極大的衝擊,但到目前為止,一切都還不錯。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • And on business development, Robyn, I wouldn't point to any changes in our approach. We address this, I think, pretty consistently on prior calls. We're looking for licensing or acquisition opportunities in the areas of our focus. So we'll continue, I think, in particular, scowering the licensing landscape at the moment. So we'll keep you posted as opportunities develop.

    至於業務拓展方面,Robyn,我不會指出我們的方法有任何改變。我認為,我們在之前的電話會議中已經相當一致地討論過這個問題。我們正在尋找我們重點關注領域的授權或收購機會。所以我認為,我們將繼續,特別是,密切關注當前的許可格局。我們會隨時向您通報最新機會。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • (Operator Instructions) Erica, go ahead.

    (操作說明)艾麗卡,請開始。

  • Operator

    Operator

  • Your next question is from Geoffrey Porges with SVB Leerink.

    您的下一個問題來自 SVB 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 on continuing with the business in trying circumstances. Just to follow up on the earlier question on omecamtiv, Dave, could you give us a sense of, it's a very well-powered study, so what sort of hazard ratio are you aiming for to achieve statistical significance? And then more importantly, perhaps, what sort of hazard ratio or benefit do you think is clinically significant, given quite a few other products that are advancing in that setting right now?

    恭喜您在如此艱困的環境下依然堅持經營。Dave,關於 omecamtiv,我想接著之前的問題問一下,這是一項非常有統計效力的研究,那麼你們的目標風險比是多少才能達到統計意義呢?更重要的是,考慮到目前該領域還有許多其他產品正在取得進展,您認為什麼樣的風險比或獲益才具有臨床意義?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes, Geoff, thanks for the question. What I would say is that the study is powered to detect what we would consider a clinically meaningful difference in outcome. The primary end point as a standard for these sorts of trials, as a composite heart failure events and cardiovascular death on the order of 15%-or-so improvement on those measures are the sorts of things that cardiologists will typically look for and consider clinically meaningful. And the study has been designed to detect those sorts of differences.

    是的,傑夫,謝謝你的提問。我想說的是,這項研究有足夠的統計效力來檢測我們認為具有臨床意義的結果差異。對於這類試驗而言,主要終點指標(複合心臟衰竭事件和心血管死亡)的標準是,這些指標改善約 15% 左右,這是心臟科醫師通常會尋找並認為具有臨床意義的指標。這項研究旨在發現這類差異。

  • Operator

    Operator

  • Your next question is from Umer Raffat with Evercore ISI.

    您的下一個問題來自 Evercore ISI 的 Umer Raffat。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I just wanted to focus on KRAS for a second. A, maybe gauge your expectations on durability of response, how you would prepare the street heading into your data? And b, if you could catch us up on whether there's any early evidence emerging on your BID dosing, and if you're seeing possible efficacy differentiation with the higher AUC at BID?

    我只想稍微集中精力談談KRAS。A,或許可以評估一下您對回應持久性的預期,以及您會如何為進入資料階段做好準備?其次,能否請您介紹一下,關於您的每日兩次給藥方案,是否有任何早期證據出現?您是否觀察到每日兩次給藥方案的 AUC 值較高,可能會帶來療效差異?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Thanks, Umer. In terms of duration of response, it's still early. As I mentioned, we're going to have an update on Phase 1 data at ESMO in roughly 6 or 7 weeks. So in that -- by the time we have those data sets, we'll get some look at duration. In BID dosing, we continue to examine. I would expect it's going to be later in the year or first part of the next year until we would have enough data to thoroughly examine both safety and then whether there's any sort of efficacy difference between monotherapy and BID dosing.

    謝謝你,烏默。就反應持續時間而言,現在還為時過早。正如我之前提到的,我們將在大約 6 到 7 週後在 ESMO 會議上公佈 1 期數據的最新進展。所以,等到我們拿到這些資料集的時候,我們就能對持續時間進行一些研究了。在每日兩次給藥方案中,我們繼續進行研究。我預計要到今年稍後或明年上半年,我們才能獲得足夠的數據來徹底檢查安全性,以及單藥治療和每日兩次給藥之間是否存在任何療效差異。

  • I would reiterate that based on everything we've seen, we remain comfortable with the monotherapy dose that we've chosen to go forward with, in terms of KRAS inhibition and, certainly, in lung cancer, that is our primary focus right now.

    我想重申,根據我們所看到的一切,我們仍然對我們選擇繼續推進的 KRAS 抑制單藥治療劑量感到滿意,當然,在肺癌方面,這是我們目前的主要關注點。

  • Operator

    Operator

  • Your next question is from Alethia Young with Cantor Fitzgerald.

    你的下一個問題來自坎托·菲茨杰拉德的阿萊西亞·楊。

  • Alethia Rene Young - Head of Healthcare Research

    Alethia Rene Young - Head of Healthcare Research

  • Congrats on the progress during the quarter. Another one on omecamtiv. I know there's roughly about 3 million people with heart failure with reduced ejection fraction, but I was hoping, Murdo, maybe you can drill that down a little bit and help us think about maybe kind of an initial population based on how the study is designed.

    恭喜你在本季的進展。omecamtiv 上還有另一個。我知道大約有 300 萬射血分數降低的心臟衰竭患者,但我希望,默多,你能再深入分析一下,幫助我們根據研究的設計來考慮初始人群。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Alethia. I would say this, and Dave's already touched on it, given that this is a slightly sicker population than some of the other recent heart failure trials, our focus is really in the institutional setting. We have made investments over the course of last year and this year to expand our cardiovascular hospital presence.

    是的。謝謝你,阿萊西亞。我想說的是,戴夫已經提到過這一點,鑑於這部分人群比最近的一些心臟衰竭試驗中的患者病情稍重,我們的重點實際上在於機構環境。過去一年和今年,我們進行了投資,以擴大我們在心血管醫院的業務。

  • We've established a cardiovascular account management team who will focus really on the more severe hospital frequent flyer, if you will, heart failure patients who really need some symptomatic improvement and need some functional improvement so that they can reduce the amount of hospitalization that they have. We also think that's where, quite frankly, the greatest value in treating heart failure can exist in the health care system. So hopefully, we have a successful trial in our hands because we still see a really good opportunity for that type of patient.

    我們已經成立了一個心血管客戶管理團隊,他們將專注於病情更嚴重的醫院常客,也就是心臟衰竭患者,這些患者確實需要一些症狀改善和功能改善,以便減少住院次數。我們也認為,坦白說,這正是醫療保健系統中治療心臟衰竭最有價值的地方。所以,希望我們能成功完成試驗,因為我們仍然看到這類患者有很大的機會。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • And I would add, Alethia, that the trial includes initiation of therapy in both hospitalized patients and nonhospitalized patients. So as Murdo mentioned, it is a little sicker population than some of the other trials that have read out recently. And heart failure is typically the leading or top handful of causes of hospitalization in most countries now. It's almost always the leading cause of rehospitalization within 30 days, which has huge economic implications. And so as Murdo mentioned, these factors really have informed our thinking about how the drug might be positioned going forward.

    我還要補充一點,Alethia,這項試驗包括對住院患者和非住院患者啟動治療。正如默多所提到的那樣,這個試驗人群的健康狀況比最近公佈的其他一些試驗人群要差一些。目前,心臟衰竭通常是大多數國家住院的主要原因或前幾大原因之一。它幾乎總是導致患者在 30 天內再次入院的主要原因,這會造成巨大的經濟影響。正如默多所提到的那樣,這些因素確實影響了我們對該藥物未來定位的思考。

  • Operator

    Operator

  • Your next question is from Cory Kasimov with JPMorgan.

    下一個問題來自摩根大通的科里·卡西莫夫。

  • Cory William Kasimov - Senior Biotechnology Analyst

    Cory William Kasimov - Senior Biotechnology Analyst

  • This one is probably for Murdo. I'm curious if you anticipate a longer-term tailwind for Neulasta Onpro that might extend beyond COVID-19 given that more providers may see the value of the product than they have previously. Just curious if you're able to gather any feedback from the field on this front during the pandemic.

    這大概是給默多的。我很好奇您是否預期 Neulasta Onpro 會獲得長期利好,這種利好可能會延續到 COVID-19 疫情之後,因為越來越多的醫療服務提供者可能會比以前更清楚地認識到該產品的價值。我只是好奇,在疫情期間,您是否能夠從第一線收集到這方面的任何回饋。

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks, Cory. The experience so far, I mean, there's really -- there's 2 drivers of that tailwind you alluded to. One is the overall utilization of long-acting filgrastim, in general, has gone up. And then, of course, the innovation that is Onpro, which allows patients to have less frequent visits to their site of care has driven some share preference for Onpro. I think we'll be able to hold quite a bit of that improvement in our share. But I'm also hoping that oncologists remain vigilant and continue to increase their usage of long-acting filgrastim in general, consistent with the NCCN guidelines.

    謝謝你,科里。就目前的經驗而言,我的意思是,確實——你提到的順風有兩個驅動因素。一是長效非格司亭的整體使用量整體上有所上升。當然,Onpro 的創新之處在於,它允許患者減少前往治療地點的次數,這在一定程度上提高了人們對 Onpro 的偏好。我認為我們能夠將相當一部分成長成果保留在我們的股份中。但我也希望腫瘤科醫師保持警惕,並繼續增加長效非格司亭的使用,這與 NCCN 指南一致。

  • Clearly, as long as COVID is out there, people should be using care strategies to minimize patients' exposure, particularly immunocompromised patients' exposure to risk. And of course, for Onpro, minimizing their exposure to the site of care where they may pick up an infection. So overall, I think we're pretty enthusiastic about what we're seeing with Neulasta and with Onpro specifically.

    顯然,只要新冠疫情仍然存在,人們就應該採取護理策略來最大限度地減少患者的暴露風險,特別是免疫功能低下的患者的暴露風險。當然,對於 Onpro 來說,也要盡量減少他們在護理場所接觸感染源的機會。總的來說,我認為我們對 Neulasta 和 Onpro 的發展前景感到非常興奮。

  • Operator

    Operator

  • Your next question is from Mohit Bansal with Citigroup.

    下一個問題來自花旗集團的莫希特·班薩爾。

  • Mohit Bansal - VP and Analyst

    Mohit Bansal - VP and Analyst

  • Congrats on the progress. One quick one on Aimovig. One of the common feedback we get from doctors is that many of these patients, migraine patients, get treated by primary care physicians and not just by a headache specialist. And that may be the reason why the penetration remains low for these agents. To that end, how do you see current subcu CGRPs expanding to primary care? Is it even possible? And what could a company like Amgen could do to make it possible?

    恭喜你取得進展。簡單介紹一下Aimovig。我們從醫生那裡得到的常見回饋之一是,許多偏頭痛患者是由初級保健醫生治療的,而不是由頭痛專家治療的。這或許就是這些藥劑滲透率仍然很低的原因。為此,您認為目前皮下CGRPs如何擴展到初級保健領域?這有可能嗎?像安進這樣的公司可以做些什麼來實現這一點呢?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Yes. Thanks, Mohit. We do have experience with primary care physician promotion. And we do have primary care physicians in our target audience. And there are those that specialize in treating migraine that become good at it. And I would say that their openness to using Aimovig is actually quite good and quite high.

    是的。謝謝,莫希特。我們在基層醫師晉升方面確實有經驗。我們的目標受眾中確實包括全科醫生。還有一些專門治療偏頭痛的醫生,他們在這方面非常擅長。我認為他們對使用 Aimovig 的接受度其實相當高。

  • I think one point that I would make that's adjacent to what you're describing is we definitely saw, in COVID and even post-COVID, some bottlenecking on the part of the neurologist and to some extent, these headache clinics in getting caught up with patient care after the March, April period of COVID disruption. And so I think we continue to watch that closely. We're seeing good improvements, but this is a stretched specialty, neurologists take care of a lot of different conditions, as you know. And the more we can expand care into primary care community-based treatment, the better, I think it will be for the growth of the category. So I would align with your observation that we need to expand the prescribing population of physicians for CGRP. And I actually see that. That's what's happening in our data.

    我認為我想提出的一點與你所描述的情況相關,那就是我們確實看到,在新冠疫情期間甚至在新冠疫情之後,神經科醫生和一些頭痛診所在應對三月、四月新冠疫情造成的混亂之後,在恢復患者護理方面出現了一些瓶頸。所以我認為我們會繼續密切關注此事。我們看到了一些不錯的改善,但是這是一個資源緊張的專科,正如你所知,神經科醫生要治療很多不同的疾病。我認為,我們越能將護理擴展到以社區為基礎的初級保健治療領域,就越有利於該領域的成長。因此,我同意你的觀點,我們需要擴大 CGRP 的處方醫生群體。我確實看到了這一點。我們的數據也反映了這一點。

  • Operator

    Operator

  • Your next question is from Carter Gould with Barclays.

    下一個問題來自巴克萊銀行的卡特·古爾德。

  • Carter Lewis Gould - Senior Analyst

    Carter Lewis Gould - Senior Analyst

  • I have a question for Peter. I was hoping he could walk through the cost of goods progression in the quarter. I appreciate the full year guidance. But in the quarter, I mean, volume was up mid-teens, biosimilars were up meaningfully. And I believe you have a meaningful royalty in that and yet non-GAAP COGS was only up 3%. Is this strictly sort of a COVID-19-related ability to sort of downshift? Or is there some other nuance I'm missing? Or does it speak to some sort of broader COGS story?

    我有個問題想問彼得。我希望他能詳細介紹一下本季商品成本的變化。感謝您提供的一整年的指導。但就本季而言,我的意思是,銷量成長了15%左右,生物相似藥的銷量也顯著成長。我相信你從中獲得了可觀的版稅,然而非GAAP銷售成本僅成長了3%。這是否完全是與新冠疫情相關的某種程度上的「放慢節奏」的能力?或者我忽略了其他一些細節?或者,這是否反映了更廣泛的成本問題?

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • Yes. Thank you, Carter. Yes. On cost of goods sold, it was just product mix in the first -- in the second quarter, rather. And so we would expect it, as we said, to be consistent with 2019 on an overall basis for the year.

    是的。謝謝你,卡特。是的。銷售成本方面,第一季主要是產品組合的問題——更精確地說,第二季的問題就出在第二季了。因此,正如我們所說,我們預計全年整體情況將與 2019 年保持一致。

  • Operator

    Operator

  • Your next question is from Salim Syed with Mizuho Securities.

    下一個問題來自瑞穗證券的Salim Syed。

  • Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research

    Salim Qader Syed - MD, Senior Biotechnology Analyst of Equity Research & Head of Biotechnology Research

  • I'll also throw in my thanks for being a leader in the industry here in shortening the prepared remarks, hopefully others can follow suit as well. I just had one question on omecamtiv, maybe for David. So David, it sounds like you're pretty bold up on this trial working and hitting the 15% bogey that you mentioned. I just want to know if there was one thing that you had to take into trial design, whether it's the sicker patients you mentioned or maybe the slight troponin elevation that we saw in cosmic, if there was one reason why this trial failed and didn't hit that 15% bogey, I'm curious what you believe that reason would be.

    我還要感謝您在縮短發言稿方面發揮了行業領導作用,希望其他人也能效仿。我有一個關於omecamtiv的問題,也許可以問David。所以大衛,聽起來你在這次試打中相當大膽,而且打出了你提到的 15% 的柏忌。我只是想知道,在試驗設計中,您是否必須考慮某個因素,無論是您提到的病情較重的患者,還是我們在 Cosmic 中看到的輕微肌鈣蛋白升高,如果有什麼原因導致這項試驗失敗,沒有達到 15% 的目標,我很想知道您認為原因是什麼。

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. Thanks, Salim. It's hard to speculate on a specific reason. Look, advanced heart failure is high-risk by its nature, and we fully recognize that. We think we've done methodologically a very good trial. But at this point, it is up to the molecule in mother nature, and we're going to know that answer in a few months.

    是的。謝謝你,薩利姆。很難推測具體原因。你看,晚期心臟衰竭本身就是高風險的,這一點我們完全體認到。我們認為,從方法論上來說,我們已經完成了一個非常好的試驗。但就目前而言,這取決於大自然中的分子,幾個月後我們就會知道答案。

  • Operator

    Operator

  • Your next question is from Dane Leone with Raymond James.

    您的下一個問題來自 Raymond James 的 Dane Leone。

  • Dane Vincent Leone - Research Analyst

    Dane Vincent Leone - Research Analyst

  • Congrats on navigating the difficult macro environment. So my one question, I just want to focus on Otezla. Clearly, the results in the mild to moderate psoriasis setting were good. You're building up an effort to go-to-market in that setting. The question we get is just how do you actually tackle that market from where the drug is being used now? And specifically and mechanistically, how are you going to open up the formularies to actually really unlock the more mild patient phenotype versus more of the moderate where you already do have penetration now?

    恭喜你成功應付了複雜的宏觀環境。所以我的問題只有一個,我只想專注於奧特茲拉。顯然,對於輕度至中度乾癬患者,治療效果良好。你正在努力在這種環境下進入市場。我們常被問到,如何才能真正從藥物目前的使用市場著手,開拓這個市場?具體來說,從機制上講,您將如何開放處方集,從而真正釋放出更多輕症患者的表型,而不是像現在這樣更多地滲透到中度患者群體中?

  • So I guess, one, on the label, how will it really read differently and open up? And then two, how are you going to work with payers, and how is that going to change the formulary status?

    所以我想,首先,從標籤來看,它究竟會如何變化,如何展現其內涵?其次,你們將如何與支付方合作,這將如何改變藥品目錄狀態?

  • Murdo Gordon - Executive VP of Global Commercial Operations

    Murdo Gordon - Executive VP of Global Commercial Operations

  • Thanks for the question, Dane. Overall, we see there's a very large population of mild to moderate patients out there, but we're really focused on those patients that tend to have larger surface area of the skin involved in their psoriasis, where they're really finding the topical treatments incompatible with the nature of their disease and looking for something better, like an oral option. And I think given the strength of the results in the clinical trial, we feel that we would be able to target and motivate that population of patients to seek an alternative to topical treatments.

    謝謝你的提問,丹恩。總的來說,我們發現輕度至中度銀屑病患者群體非常龐大,但我們真正關注的是那些銀屑病累及皮膚面積較大的患者,他們發現局部治療與他們的疾病性質不相符,並正在尋找更好的治療方法,例如口服藥物。我認為,鑑於臨床試驗結果的強勁性,我們感覺我們能夠有針對性地激勵這部分患者尋求局部治療的替代方案。

  • Much the way Otezla is currently used today, which is post-topical, pre-biologic, we think it's really a logical expansion of our current positioning. From our interactions with prescribers, we've been encouraged by their enthusiasm for what Otezla might offer these individuals, these patients.

    就像 Otezla 目前在局部用藥後、生物製劑用藥前使用一樣,我們認為這確實是我們目前定位的合乎邏輯的擴展。從我們與處方醫生的交流中,我們深受鼓舞,他們對 Otezla 可能為這些患者帶來的益處充滿熱情。

  • The other thing I would say is we did, at the end of last year, initiate a primary care promotional effort on Otezla, something that our legacy Celgene colleagues couldn't do or had not done, and we were able to try that out. And we actually saw a good promotional response there. So we have the ability, given the scale of our primary care field force, to add Otezla to the mix there. I think that will help grow our commercial presence. We also are cross-training all of our Enbrel field force on Otezla to ensure that we have maximum presence for, hopefully, an approved indication in not-too-distant future.

    我還要補充一點,去年年底,我們啟動了一項針對 Otezla 的初級保健推廣活動,這是我們以前的 Celgene 同事無法做到或沒有做到的,我們得以嘗試一下。事實上,我們看到了不錯的推廣效果。鑑於我們基層醫療團隊的規模,我們有能力將 Otezla 也納入其中。我認為這將有助於擴大我們的商業影響力。我們也對所有 Enbrel 銷售人員進行 Otezla 的交叉培訓,以確保我們擁有最大的市場影響力,希望在不久的將來 Otezla 能夠獲得批准適應症。

  • With respect to access, which you mentioned specifically, because again -- because of the very good cost benefit of Otezla compared to particularly to biologic options, we've actually got very good coverage in this patient population today, not mild to moderate, but in the moderate to severe patient population today that we think we will be able to expand without too much gross-to-net erosion. So we're feeling pretty good about this growth opportunity. I'm pleased with how Otezla has performed since we integrated into our portfolio. It is performing ahead of our expectations in TRx, and that's with some nominal COVID pandemic impact on the overall dermatology category. So so far, so good.

    關於您特別提到的獲取途徑,因為 Otezla 的成本效益非常好,尤其與生物製劑相比,我們目前在這個患者群體中擁有非常好的覆蓋率,不是輕度到中度,而是中度到重度患者群體,我們認為我們能夠在不造成太大毛利到淨利利損失的情況下擴大覆蓋範圍。所以我們對這個成長機會感到非常樂觀。我對 Otezla 加入我們的投資組合後的表現感到滿意。在 TRx 領域,它的表現超出了我們的預期,而且這還是在 COVID 疫情對整個皮膚科領域造成輕微影響的情況下。目前為止,一切順利。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Erica, we have 4 minutes remaining. Let's take 1 last question, after which Bob is going to make some concluding comments.

    艾麗卡,我們還有4分鐘。我們來看最後一個問題,之後鮑伯將做一些總結性評論。

  • Operator

    Operator

  • Yes. Your final question is from Michael Schmidt with Guggenheim Securities.

    是的。最後一個問題來自古根漢證券的邁克爾·施密特。

  • Michael Werner Schmidt - Senior Analyst & Senior MD

    Michael Werner Schmidt - Senior Analyst & Senior MD

  • I had a follow-up on the KRAS program. Sotorasib is obviously being also evaluated in multiple combinations with other agents. How do you see those various combinations positioned relative to each other, for example, if there's indication overlaps such as in lung cancer potentially? And secondly, I guess, what do we need to see from the KEYTRUDA combination in lung cancer, which I believe is most advanced in development, to advance that particular combination into the next development phase?

    我有一個關於 KRAS 計畫的後續研究。顯然,Sotorasib 也正在與其他多種藥物進行聯合用藥的評估。您如何看待這些不同的組合之間的相對位置,例如,如果存在適應症重疊,例如肺​​癌方面?其次,我想問的是,在肺癌治療中,KEYTRUDA聯合療法(我認為是目前研發進展最快的療法)需要達到怎樣的水平,才能將其推進到下一個研發階段?

  • David M. Reese - EVP of Research & Development

    David M. Reese - EVP of Research & Development

  • Yes. Thanks for the question. The combinations, as you indicate, would potentially cover a range of indications or diseases as well as different lines of therapy. Other maybe partial overlap as these data sets emerge, of course, we would go -- we will evaluate them and determine where we think the most promise-wise, I think it's too early. It's early days, and too early to call horses there.

    是的。謝謝你的提問。正如您所指出的,這些組合藥物可能涵蓋一系列適應症或疾病,以及不同的治療方案。隨著這些資料集的出現,其他資料集之間可能存在部分重疊,當然,我們會對其進行評估,並確定我們認為最有前景的資料集,但我認為現在還為時過早。現在下結論還為時過早,現在就斷言那裡的情況好轉還為時過早。

  • The KEYTRUDA combination started first, but there are a half dozen in the clinic now. And as we move along in the coming months, we'll give guidance, and we look forward to sharing those data. We know they're not in their interest for this program and for the entire field as this program moves forward. It continues to move quite quickly.

    KEYTRUDA 聯合療法最早推出,但現在臨床上已經有六種不同的合併療法了。在接下來的幾個月裡,我們將提供指導,並期待與大家分享這些數據。我們知道,隨著該計畫的推進,他們的行為不符合他們自身的利益,也不符合整個領域的利益。它依然快速移動。

  • Robert A. Bradway - Chairman, CEO & President

    Robert A. Bradway - Chairman, CEO & President

  • All right, everyone. I want to wrap up so that we can close here at the top of the hour as promised. But let me just simply thank you for your ongoing interest and support of our company. I know we're all operating in unprecedented times here. But we feel like we're in a strong position, operating the company well and particularly grateful with our staff worldwide who are as engaged as they are in our mission even in this challenging time we find ourselves in.

    好了,各位。我想盡快結束今天的節目,以便我們能按約定在整點準時結束。但請容許我簡單地感謝您一直以來對我們公司的關注與支持。我知道我們現在都身處前所未有的時代。但我們感覺我們處於有利地位,公司運作良好,尤其感謝我們遍布全球的員工,即使在我們面臨如此充滿挑戰的時期,他們仍然全心投入我們的使命。

  • So thank you again for your ongoing support. We will be available to answer your questions if you have any follow-on after our call. And we look forward to connecting with you after the third quarter. Thank you.

    再次感謝您一直以來的支持。通話結束後,如果您有任何後續問題,我們將隨時為您解答。我們期待在第三季結束後與您聯繫。謝謝。

  • Peter H. Griffith - Executive VP & CFO

    Peter H. Griffith - Executive VP & CFO

  • Great. Thank you, everybody.

    偉大的。謝謝大家。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes Amgen's Second Quarter 2020 Financial Results Conference Call. You may now disconnect.

    女士們、先生們,安進公司2020年第二季財務業績電話會議到此結束。您現在可以斷開連線了。