施貴寶 (BMY) 2022 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day, and welcome to the Bristol-Myers Squibb Second Quarter Results Conference Call. Today's conference is being recorded.

    美好的一天,歡迎參加百時美施貴寶第二季度業績電話會議。今天的會議正在錄製中。

  • At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir.

    此時,我想將會議轉交給投資者關係副總裁 Tim Power 先生。請繼續,先生。

  • Timothy Power - VP & Head of IR

    Timothy Power - VP & Head of IR

  • Thanks, Sarah, and good morning, everyone. Thanks for joining us this morning for our second quarter 2022 earnings call.

    謝謝,莎拉,大家早上好。感謝您今天早上參加我們的 2022 年第二季度財報電話會議。

  • I'm joined this morning with prepared remarks by Giovanni Caforio, our Board Chair and Chief Executive Officer; and by David Elkins, our Chief Financial Officer. And also taking part in today's call are Chris Boerner, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development.

    今天上午,我們的董事會主席兼首席執行官喬瓦尼·卡福里奧 (Giovanni Caforio) 準備發表講話。以及我們的首席財務官 David Elkins。我們的首席商業官 Chris Boerner 也參加了今天的電話會議;以及我們的首席醫療官兼全球藥物開發主管 Samit Hirawat。

  • You'll note that we posted slides to bms.com that you can use to follow along with for Giovanni and David's remarks. But before we get started, I'll read our forward-looking statements.

    您會注意到我們在 bms.com 上發布了幻燈片,您可以使用這些幻燈片來了解 Giovanni 和 David 的評論。但在我們開始之前,我將閱讀我們的前瞻性陳述。

  • During this call, we will make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should be not relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change.

    在本次電話會議中,我們將對構成前瞻性陳述的公司未來計劃和前景發表聲明。由於各種重要因素,包括公司提交給美國證券交易委員會的文件中討論的因素,實際結果可能與這些前瞻性陳述所表明的結果存在重大差異。這些前瞻性陳述代表我們截至今天的估計,不應被視為代表我們對任何未來日期的估計。即使我們的估計發生變化,我們也明確表示不承擔更新前瞻性陳述的義務。

  • We'll also focus our comments on our non-GAAP financial measures, which were adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com.

    我們還將把我們的評論集中在我們的非公認會計原則財務指標上,這些指標經過調整以排除某些特定項目。 bms.com 上提供了某些非 GAAP 財務指標與最具可比性的 GAAP 指標的對賬。

  • And I'll hand it over now to Giovanni.

    我現在把它交給喬瓦尼。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Tim, and good morning, everyone. Let's start with our second quarter performance on Slide 4.

    謝謝蒂姆,大家早上好。讓我們從幻燈片 4 的第二季度表現開始。

  • We are midway through 2022, and we've made great progress during an important year for the company. We continued to grow our in-line franchises, expand our new product portfolio, advance our pipeline and execute important business development activities. Our foundation is strong and positions us well for growth.

    我們已經進入 2022 年,在公司重要的一年裡,我們取得了長足的進步。我們繼續發展我們的在線特許經營權,擴大我們的新產品組合,推進我們的管道並執行重要的業務發展活動。我們的基礎很牢固,為我們的增長做好了準備。

  • With respect to our commercial performance, we delivered continued sales growth, with revenue up 5%, adjusting for foreign exchange, and non-GAAP EPS increasing by 18%. The strong revenue growth was driven by excellent commercial execution, with solid year-over-year growth for our in-line brands, particularly for Eliquis and our I-O franchise and significant momentum from our new product portfolio.

    就我們的商業業績而言,我們實現了持續的銷售增長,收入增長了 5%,經外匯調整後,非公認會計準則每股收益增長了 18%。強勁的收入增長是由出色的商業執行推動的,我們的在線品牌,尤其是 Eliquis 和我們的 I-O 特許經營權,以及我們新產品組合的強勁勢頭,實現了穩健的同比增長。

  • Within our new product portfolio, Opdualag, our third I-O agent, is off to a great start, and we are pleased with the team's early execution. Opdualag strengthens our position in I-O and accelerates the sustainability and growth of our I-O franchise.

    在我們的新產品組合中,我們的第三個 I-O 代理 Opdualag 有了一個良好的開端,我們對團隊的早期執行感到高興。 Opdualag 加強了我們在 I-O 中的地位,並加速了我們 I-O 特許經營權的可持續性和增長。

  • We are also establishing a strong foundation for Camzyos as the first agent that effectively treats the underlying condition of symptomatic obstructive HCM. We see a lot of potential to drive significant penetration in this large underserved and underdiagnosed population.

    我們還為 Camzyos 作為第一個有效治療症狀性阻塞性 HCM 潛在疾病的藥物奠定了堅實的基礎。我們看到在這一龐大的服務不足和診斷不足的人群中推動重大滲透的潛力很大。

  • We also made great progress advancing our broad set of pipeline opportunities through regulatory approvals and clinical trial readouts during the quarter. In hematology, we received U.S. FDA approval for Breyanzi, with a best-in-class label in second-line large B-cell lymphoma as well as EMA validation. With this approval, Breyanzi now has the broadest patient eligibility of any CAR T cell therapy in relapsed or refractory LBCL. This reinforces our opportunity for leadership in cell therapy and further strengthens our view of Breyanzi as a key growth driver for the company, with over $3 billion in nonrisk-adjusted revenue potential in 2029.

    我們還在本季度通過監管批准和臨床試驗讀數在推進我們廣泛的管道機會方面取得了巨大進展。在血液學方面,我們的 Breyanzi 獲得了美國 FDA 的批准,在二線大 B 細胞淋巴瘤中獲得了同類最佳的標籤以及 EMA 驗證。有了這項批准,Breyanzi 現在在復發或難治性 LBCL 中擁有任何 CAR T 細胞療法的最廣泛患者資格。這加強了我們在細胞治療領域處於領先地位的機會,並進一步加強了我們對 Breyanzi 作為公司關鍵增長動力的看法,2029 年非風險調整後的收入潛力超過 30 億美元。

  • In cardiovascular, we delivered positive Phase II data for milvexian in secondary stroke prevention. And we're looking forward to this data being presented at the European Society of Cardiology meeting next month. With this data in hand, we plan to initiate our Phase III program by the end of the year, which provides an important opportunity to improve outcomes for patients and extend our world-leading antithrombotic business into the next decade.

    在心血管方面,我們為 milvexian 在卒中二級預防中提供了積極的 II 期數據。我們期待著在下個月的歐洲心髒病學會會議上公佈這些數據。有了這些數據,我們計劃在今年年底前啟動我們的 III 期計劃,這為改善患者的預後和將我們世界領先的抗血栓形成業務擴展到下一個十年提供了重要機會。

  • And in oncology, we continue to strengthen the growth outlook for Opdivo with another indication in GI cancers, where it now has a leading position.

    在腫瘤學方面,我們繼續加強 Opdivo 的增長前景,並在 GI 癌症中佔據領先地位。

  • During the quarter, our financial results were strong, with growth in our in-line and new product businesses. Our financial strength continues to provide us with significant flexibility to deploy capital in a balanced way, including for business development. And during the quarter, we announced an agreement to acquire Turning Point Therapeutics, a leading precision oncology company.

    在本季度,我們的財務業績強勁,在線和新產品業務增長。我們的財務實力繼續為我們提供顯著的靈活性,以平衡的方式部署資本,包括用於業務發展。在本季度,我們宣布了一項收購領先的精準腫瘤學公司 Turning Point Therapeutics 的協議。

  • On Slide 5, let's discuss Turning Point's lead asset, repotrectinib, which is a next-generation potential best-in-class TKI, targeting the ROS and NTRK driver mutations of non-small cell lung cancer and advanced solid tumors. Importantly, as you can see on the slide, the key first-line lung cancer data that has been announced for repotrectinib is differentiated from potential competitors on duration of response and safety profile.

    在幻燈片 5 上,讓我們討論 Turning Point 的主要資產 repotrectinib,它是下一代潛在的同類最佳 TKI,針對非小細胞肺癌和晚期實體瘤的 ROS 和 NTRK 驅動突變。重要的是,正如您在幻燈片上看到的那樣,已公佈的用於 repotrectinib 的關鍵一線肺癌數據在反應持續時間和安全性方面與潛在競爭對手不同。

  • This acquisition will broaden our portfolio in precision oncology and in solid tumors, and it is a strategic fit for the company. We expect the transaction to close in the third quarter of this year and believe it would support our medium- to long-term growth strategy, with accretion to non-GAAP EPS beginning in 2025. We plan to continue to leverage our financial strength to pursue transformational science through business development.

    此次收購將擴大我們在精準腫瘤學和實體瘤領域的投資組合,對公司而言是戰略契合。我們預計該交易將在今年第三季度完成,並相信它將支持我們的中長期增長戰略,並從 2025 年開始增加非公認會計準則每股收益。我們計劃繼續利用我們的財務實力追求通過業務發展轉變科學。

  • Turning to our execution scorecard on Slide 6. We know the importance of continued delivery of key pipeline milestones, and we have made tremendous progress across therapeutic areas this year. In addition to the key milestones I already mentioned for Breyanzi and milvexian, we have reached mid- to late-stage pipeline, and we are accelerating the next generation of potential medicines. Over time, we believe iberdomide and CC-480 or mezigdomide have the potential to play an important role in multiple myeloma. In that regard, we made good progress during the quarter, having moved iberdomide into its first registrational trial in the second-line setting of multiple myeloma.

    轉到幻燈片 6 上的執行記分卡。我們知道繼續交付關鍵管道里程碑的重要性,今年我們在治療領域取得了巨大進展。除了我已經提到的 Breyanzi 和 milvexian 的關鍵里程碑外,我們已經進入了中後期管道,我們正在加速下一代潛在藥物的開發。隨著時間的推移,我們相信 iberdomide 和 CC-480 或 mezigdomide 有可能在多發性骨髓瘤中發揮重要作用。在這方面,我們在本季度取得了良好進展,已將 iberdomide 轉移到多發性骨髓瘤二線環境中的首次註冊試驗。

  • Looking ahead, I am encouraged by the breadth of opportunities for the rest of this year and beyond. We look forward to the PDUFA date for deucravacitinib in psoriasis in September. We're excited for the opportunity to bring this oral-of-choice medicine to moderate-to-severe psoriasis patients soon. With multiple indications on the horizon beyond psoriasis, we believe that this asset has greater than $4 billion in nonrisk-adjusted revenue potential in 2029.

    展望未來,我對今年餘下時間及以後的廣泛機會感到鼓舞。我們期待 9 月 deucravacitinib 治療銀屑病的 PDUFA 日期。我們很高興有機會將這種口服首選藥物很快帶給中度至重度銀屑病患者。隨著銀屑病以外的多種跡像出現,我們認為該資產在 2029 年具有超過 40 億美元的非風險調整收入潛力。

  • In addition, we also expect to see data to support important expansion opportunities for other key medicines over time. These include key data for Abecma, Opdivo, Opdualag and Reblozyl. We hope that this data will enable these medicines to benefit more patients and further expand their commercial potential. I remain excited about the multiple opportunities we have across our pipeline, and I look forward to continuing to update you on our progress.

    此外,隨著時間的推移,我們還希望看到數據支持其他關鍵藥物的重要擴張機會。其中包括 Abecma、Opdivo、Opdualag 和 Rebrozyl 的關鍵數據。我們希望這些數據能讓這些藥物惠及更多患者,進一步擴大其商業潛力。我仍然對我們在管道中擁有的多種機會感到興奮,我期待繼續向您通報我們的進展。

  • As I review our performance during the first half of 2022, I'm very proud of the employees of Bristol-Myers Squibb around the world. Together, we have built the foundation for an even stronger company, with a more diversified portfolio of growth products and increased durability across each of our 4 key therapeutic areas. Our performance in the quarter continues to demonstrate the resiliency of our business and our continued financial strength. We believe this positions us well to continue to grow our business in an increasingly complex external environment. This includes macroeconomic factors, such as the strengthening U.S. dollar and accelerating inflation as well as legislative headwinds in the U.S. Given our growing and rapidly diversifying business and our continued financial flexibility, we remain very well positioned for the future.

    當我回顧我們在 2022 年上半年的表現時,我為全球百時美施貴寶的員工感到非常自豪。我們共同為一家更強大的公司奠定了基礎,在我們的 4 個關鍵治療領域中,我們擁有更多樣化的增長產品組合和更高的耐用性。我們在本季度的表現繼續證明我們業務的彈性和我們持續的財務實力。我們相信這使我們能夠在日益複雜的外部環境中繼續發展我們的業務。這包括宏觀經濟因素,例如美元走強和通脹加速,以及美國的立法逆風。鑑於我們不斷增長和迅速多樣化的業務以及我們持續的財務靈活性,我們為未來做好了充分的準備。

  • With that, I'll turn it over to David to walk you through the financials in detail. David?

    有了這個,我會把它交給大衛,讓你詳細了解財務狀況。大衛?

  • David V. Elkins - Executive VP & CFO

    David V. Elkins - Executive VP & CFO

  • Thank you, Giovanni, and thanks, again, for all of you joining our second quarter earnings call. Let's turn to Slide 8 to discuss our solid top line performance. Unless otherwise stated, I will discuss our sales performance growth rates on an underlying basis, which excludes the impact of foreign exchange.

    謝謝喬瓦尼,再次感謝大家參加我們的第二季度財報電話會議。讓我們轉到幻燈片 8 來討論我們穩健的頂線表現。除非另有說明,否則我將在不包括外匯影響的基礎上討論我們的銷售業績增長率。

  • Second quarter revenues were approximately $11.9 billion, growing 5% year-over-year. This performance was driven by robust growth of our in-line and new product portfolio of 16%, more than offsetting our recent LOEs.

    第二季度收入約為 119 億美元,同比增長 5%。這一業績是由我們在線和新產品組合 16% 的強勁增長推動的,超過了我們最近的 LOE。

  • Let's now double-click on our new product portfolio performance on Slide 9. Global revenues were nearly $500 million, more than doubling revenue versus prior year. Growth over prior quarter was also very strong, up 38%, primarily due to strong launches of Abecma and Opdualag, which I will touch on in a moment. I'm very pleased with the performance of our new product portfolio and its future potential, with 2 additional launches year-to-date and deucravacitinib's anticipated approval in 6 weeks. Our new product portfolio has significant expansion opportunities and the potential to generate greater $25 billion in revenue on a nonrisk-adjusted basis in 2029. I look forward to updating you on these products as they continue to realize their full potential.

    現在讓我們在幻燈片 9 上雙擊我們的新產品組合表現。全球收入接近 5 億美元,收入比去年增加了一倍多。與上一季度相比,增長也非常強勁,增長了 38%,這主要是由於 Abecma 和 Opdualag 的強勁推出,我稍後會談到。我對我們新產品組合的表現及其未來潛力感到非常滿意,今年迄今還有 2 次推出,預計 deucravacitinib 將在 6 週內獲得批准。我們的新產品組合具有顯著的擴展機會,並且在 2029 年非風險調整基礎上可能產生 250 億美元的收入。隨著這些產品繼續發揮全部潛力,我期待著向您介紹這些產品的最新信息。

  • The performance of our solid tumor portfolio, shown on Slide 10, was strong. Opdivo sales in the quarter continued to grow globally, driven by demand for our newly launched and core indications. In the U.S., we delivered 12% growth for Opdivo versus prior year, driven by demand in first-line lung, renal and gastric cancer as well as adjuvant esophageal and bladder cancers, partially offset by some -- Opdualag in first-line melanoma.

    我們在幻燈片 10 上展示的實體瘤產品組合表現強勁。在對我們新推出的核心適應症的需求的推動下,本季度 Opdivo 的銷售額在全球範圍內繼續增長。在美國,由於一線肺癌、腎癌和胃癌以及輔助食道癌和膀胱癌的需求,我們為 Opdivo 實現了 12% 的增長,但部分被一線黑色素瘤中的 Opdualag 所抵消。

  • Internationally, revenues were also strong, growing 13% primarily due to growth from new indications, particularly first-line lung and renal cancers as we continue to secure reimbursement in many countries. Looking forward, we expect continued growth from Opdivo from our new and expanding indications in both early and late-stage cancers.

    在國際上,收入也很強勁,增長了 13%,主要是由於新適應症的增長,特別是一線肺癌和腎癌,因為我們繼續在許多國家獲得報銷。展望未來,我們預計 Opdivo 將繼續增長,因為我們在早期和晚期癌症方面的新適應症和不斷擴大的適應症。

  • Yervoy sales grew 7% globally, and in the U.S., revenues were consistent with prior year as we experienced some variability in RCC and melanoma as well as higher inventory burn and gross-to-net adjustments this year. Importantly, sequential revenues grew 5%, primarily driven by demand in first-line lung cancer, and we continue to expect growth for the brand.

    Yervoy 的全球銷售額增長了 7%,在美國,收入與上一年保持一致,因為我們今年經歷了 RCC 和黑色素瘤的一些變化,以及更高的庫存消耗和總淨值調整。重要的是,連續收入增長了 5%,主要受一線肺癌需求的推動,我們繼續預計該品牌的增長。

  • Now to our strong launch of Opdualag, the first fixed-dose combination of a LAG-3 and PD-1 inhibitor. While still early in the launch, we have already generated $58 million of sales in the quarter, driven primarily by robust demand and $10 million of stocking. The robust demand for Opdualag has mainly been in line with our strategy, taking share from PD-1 monotherapy and, as expected, some use in place of Opdivo-Yervoy combination. Internationally, we are pleased with the recent CHMP positive opinion in Europe and look forward to realizing Opdualag's potential to be a new standard of care in patients with metastatic melanoma around the world.

    現在我們強勢推出 Opdualag,這是第一個 LAG-3 和 PD-1 抑製劑的固定劑量組合。雖然仍處於發布初期,但我們在本季度已經產生了 5800 萬美元的銷售額,這主要得益於強勁的需求和 1000 萬美元的庫存。對 Opdualag 的強勁需求主要符合我們的戰略,從 PD-1 單一療法中獲得份額,並且正如預期的那樣,一些用於代替 Opdivo-Yervoy 組合。在國際上,我們對歐洲最近 CHMP 的積極意見感到高興,並期待著實現 Opdualag 成為全球轉移性黑色素瘤患者新護理標準的潛力。

  • Turning to our growing cardiovascular portfolio on Slide 11, starting with Eliquis, our leading OAC globally, with strong revenue growth of 20% year-over-year. In the U.S., sales increased 27% versus prior year, driven primarily by demand growth and favorable gross-to-net adjustments. As a reminder, looking to the third and fourth quarters, we expect the usual dynamics for Medicare coverage gap, with second half revenues being lower than first half as we've seen in previous years.

    在幻燈片 11 上轉向我們不斷增長的心血管產品組合,從我們全球領先的 OAC Eliquis 開始,收入同比增長 20%。在美國,銷售額同比增長 27%,主要受需求增長和有利的毛淨值調整的推動。提醒一下,展望第三和第四季度,我們預計醫療保險覆蓋缺口的通常動態,下半年收入低於我們在前幾年看到的上半年。

  • Internationally, sales grew 9% versus a year ago. This growth was primarily driven by increased share across key markets as the brand continues to be the #1 OAC in multiple countries. This was partially offset by pricing actions in many markets as demand grows and, to a smaller extent, at-risk generic launch in the U.K. and the Netherlands. For the second half of the year, we expect the impact of at-risk generic launch to be approximately $250 million.

    在國際上,銷售額與一年前相比增長了 9%。這一增長主要是由於該品牌在多個國家/地區繼續成為排名第一的 OAC,因此在主要市場的份額增加。隨著需求的增長,許多市場的定價行動部分抵消了這一影響,在較小程度上,英國和荷蘭面臨風險的仿製藥上市。今年下半年,我們預計風險仿製藥上市的影響約為 2.5 億美元。

  • Now turning to our most recent launch, Camzyos. As you know, the vast majority of patients initiating treatment on Camzyos are starting on a free trial offer for at least 30 days. And then the $3 million recorded in revenue in the quarter was mainly due to stocking. During the second quarter, we have successfully laid the foundation, leveraging our strong CV leadership in REMS to certify over 1,000 health care professionals. We are now focused on broadening our user base and supporting the initiation of patients on Camzyos. We are pleased with the physician feedback thus far and look forward to helping more patients living with symptomatic oHCM.

    現在轉向我們最近推出的 Camzyos。如您所知,絕大多數在 Camzyos 上開始治療的患者都開始免費試用至少 30 天。然後本季度錄得的 300 萬美元收入主要是由於庫存。在第二季度,我們已經成功奠定了基礎,利用我們在 REMS 中強大的 CV 領導力,為 1,000 多名醫療保健專業人員提供了認證。我們現在專注於擴大我們的用戶群並支持在 Camzyos 上啟動患者。到目前為止,我們對醫生的反饋感到滿意,並期待幫助更多患有症狀性 oHCM 的患者。

  • Moving on to a few of our hematology products on Slide 12, starting with Revlimid. Sales in the quarter were approximately $2.5 billion. Sales were primarily impacted by generic entry, particularly in international markets. In the U.S., while we did experience demand softness from the volume-limited generic entry in the quarter, we understand that specialty pharmacies are mainly utilizing the current generic for new patients to ensure continuity of treatment. As mentioned in the past, we know there will be variability quarter-to-quarter based on how generics will deploy their volume. As additional entrants will be coming to the market in the U.S. in the third quarter, we expect Q3 revenues to be approximately $2.1 billion. We maintained our full year global sales guidance of $9 billion to $9.5 billion.

    在幻燈片 12 上繼續介紹我們的一些血液學產品,從 Revlimid 開始。本季度的銷售額約為 25 億美元。銷售主要受到仿製藥進入的影響,尤其是在國際市場。在美國,雖然我們確實經歷了本季度數量有限的仿製藥進入的需求疲軟,但我們了解到專業藥房主要將當前的仿製藥用於新患者,以確保治療的連續性。正如過去所提到的,我們知道根據仿製藥將如何部署其數量,每個季度都會有變化。由於第三季度將有更多的進入者進入美國市場,我們預計第三季度的收入約為 21 億美元。我們維持 90 億至 95 億美元的全年全球銷售指導。

  • Pomalyst global revenues grew 9% versus prior year, primarily driven by demand for triple-base regimens in earlier lines and extending duration of treatment.

    Pomalyst 全球收入較上年增長 9%,主要是由於對早期產品線中三基療法的需求和延長治療持續時間。

  • Now moving to Reblozyl, which generated $172 million in the quarter, up a strong 36% versus prior year. In the U.S., we are seeing encouraging trends in patient adherence and extended treatment duration. Outside of the U.S., Reblozyl continues to grow, driven by demand in both MDS and beta thalassemia-associated anemia and as we obtained reimbursement in additional countries.

    現在轉向 Rebrozyl,該季度產生了 1.72 億美元,比去年同期增長了 36%。在美國,我們看到了患者依從性和延長治療時間方面令人鼓舞的趨勢。在美國以外,Rebrozyl 繼續增長,這得益於 MDS 和 β 地中海貧血相關性貧血的需求以及我們在其他國家獲得了報銷。

  • Finally, turning to our cell therapy assets, Abecma and Breyanzi. Abecma generated strong revenues in the quarter, equaling $89 million. This represents a 36% sequential increase over last quarter, driven by expanded capacity and vector supply. Though we're encouraged to treat more multiple myeloma patients, demand continues to outpace supply, and we are focused on further expanding capacity, including additional manufacturing sites in the future.

    最後,轉向我們的細胞治療資產 Abecma 和 Breyanzi。 Abecma 在本季度創造了強勁的收入,達到 8900 萬美元。這比上一季度環比增長 36%,這主要得益於產能和載體供應的擴大。儘管我們被鼓勵治療更多的多發性骨髓瘤患者,但需求繼續超過供應,我們專注於進一步擴大產能,包括未來增加生產基地。

  • As it relates to Breyanzi, sales in the quarter were $39 million. Demand remained strong for the brand, although sales were impacted by lower-than-expected manufacturing success rates, which now have been addressed. Importantly, as Giovanni mentioned, we are very pleased to have received a differentiated broad second-line label in large B-cell lymphoma patients. We are working hard and investing to expand capacity early next year to enable uptake for this indication. As we work through building additional capacity to treat more patients in earlier lines, we expect revenues in the third and fourth quarters to be largely similar to the first quarter of this year.

    由於與 Breyanzi 有關,本季度的銷售額為 3900 萬美元。儘管銷售受到低於預期的製造成功率的影響,但該品牌的需求仍然強勁,該問題現已得到解決。重要的是,正如 Giovanni 所提到的,我們很高興在大 B 細胞淋巴瘤患者中獲得了差異化的廣泛二線標籤。我們正在努力工作並投資於明年初擴大產能,以實現這一跡象。隨著我們努力建立額外的能力以治療更多早期患者,我們預計第三和第四季度的收入將與今年第一季度基本相似。

  • Moving on to our immunology product summary on Slide 13. Orencia global sales grew 11% versus prior year due to expanded U.S. sales driven by increased market share as well as demand in international markets.

    繼續我們在幻燈片 13 上的免疫學產品摘要。由於市場份額增加和國際市場需求推動美國銷售擴大,Orencia 全球銷售額比上年增長 11%。

  • Turning to Zeposia, global sales for the quarter were $66 million, more than doubling sales versus last year, primarily due to expansion of Zeposia into ulcerative colitis. Sequentially, in the U.S., sales were primarily driven by a combination of favorable gross to net and wholesale buying patterns of approximately $20 million. Importantly, we're encouraged by the 24% demand growth over the previous quarter, and we remain focused on working to for expand volume, so we can continue to improve access in 2023. Internationally, Zeposia continues to secure reimbursement in other markets for MS and UC.

    談到 Zeposia,該季度的全球銷售額為 6600 萬美元,是去年銷售額的兩倍多,這主要是由於 Zeposia 擴展到潰瘍性結腸炎。隨後,在美國,銷售額主要由有利的總淨額和約 2000 萬美元的批發購買模式共同推動。重要的是,我們對上一季度 24% 的需求增長感到鼓舞,我們仍然專注於擴大銷量,因此我們可以在 2023 年繼續改善准入。在國際上,Zeposia 繼續確保 MS 在其他市場的報銷和加州大學。

  • Closing out on immunology. We very much look forward to broadening our portfolio with another first-in-class asset, our selective TYK2 inhibitor, deucravacitinib. Our commercial and medical teams are in place, and we're ready for launch.

    結束免疫學。我們非常期待通過另一種一流的資產——我們的選擇性 TYK2抑製劑 deucravacitinib 來擴大我們的產品組合。我們的商業和醫療團隊已經到位,我們已經準備好發射。

  • Now let's turn to Slide 14 to discuss the second quarter P&L. I've already discussed our revenue, so I'll now focus on the other key line item -- non-GAAP line items. Gross margins decreased primarily due to product mix, partially offset by foreign exchange and related hedging settlements.

    現在讓我們轉到幻燈片 14 來討論第二季度的損益。我已經討論了我們的收入,所以我現在將關注另一個關鍵項目——非 GAAP 項目。毛利率下降主要是由於產品組合,部分被外彙和相關對沖結算所抵消。

  • Our operating expenses, excluding acquired in-process R&D, were broadly in line with prior year, driven by higher investments around our new product portfolio and pipeline, offset primarily by foreign exchange.

    我們的運營費用(不包括獲得的進行中的研發)與上一年基本持平,這是由於圍繞我們的新產品組合和管道的投資增加,主要被外匯抵消。

  • Acquired in-process R&D charges in the quarter were $400 million, primarily driven by the buyout of a royalty obligation for Camzyos of $295 million as well as a $90 million upfront for BridgeBio. This accounted for a 17% impact to diluted EPS. Acquired in-process R&D charges in the prior year were approximately $793 million, which accounted for a $0.30 impact to diluted EPS.

    本季度獲得的進行中研發費用為 4 億美元,主要是由於收購了 Camzyos 2.95 億美元的特許權使用費義務以及 BridgeBio 的 9000 萬美元預付款。這對攤薄每股收益造成了 17% 的影響。上一年獲得的進行中研發費用約為 7.93 億美元,對攤薄每股收益產生 0.30 美元的影響。

  • The second quarter tax rate was impacted by earnings mix. And lastly, we delivered strong non-GAAP EPS growth in the quarter, up 18% year-over-year. This includes the $0.14 impact of acquired in-process R&D. Excluding acquired in-process R&D, non-GAAP EPS would have grown 7%.

    第二季度稅率受到盈利組合的影響。最後,我們在本季度實現了強勁的非公認會計原則每股收益增長,同比增長 18%。這包括獲得的進行中研發的 0.14 美元影響。不包括收購的進行中研發,非公認會計原則每股收益將增長 7%。

  • Now moving to the balance sheet and capital allocation on Slide 15. The company's balance sheet remains strong, with $13.2 billion in cash and market securities on hand as of June 30. Cash flow from operations in the first half of the year was $6.1 billion. In the quarter, it was approximately $2.3 billion, which is impacted by a cash tax payment, and we expect cash flow from operations to rebound in Q3 and Q4.

    現在轉到幻燈片 15 上的資產負債表和資本配置。該公司的資產負債表依然強勁,截至 6 月 30 日手頭有 132 億美元的現金和市場證券。今年上半年的運營現金流為 61 億美元。本季度約為 23 億美元,受現金稅影響,我們預計運營現金流將在第三季度和第四季度反彈。

  • Our capital allocation priorities remain unchanged. Business development continues to be a top priority, and we continue to execute on this priority with the announcement of the planned acquisition of Turning Point Therapeutics.

    我們的資本配置重點保持不變。業務發展仍然是重中之重,我們通過宣布計劃收購 Turning Point Therapeutics 繼續執行這一優先事項。

  • We remain committed to continued debt reduction. In the quarter, we repaid $2.9 billion of debt.

    我們仍然致力於繼續減少債務。本季度,我們償還了 29 億美元的債務。

  • And we remain committed to returning capital to shareholders. We executed a $5 billion ASR earlier this year and remain opportunistic about repurchases in the future.

    我們仍然致力於向股東返還資本。今年早些時候,我們執行了 50 億美元的 ASR,並且對未來的回購持機會主義態度。

  • Now turning to our 2022 non-GAAP guidance on Slide 16. We are updating our revenue guidance to be approximately $46 billion this year, reflecting the significant appreciation of the U.S. dollar to other global currencies. Excluding the effects of currency, the underlying sales growth for the business is expected to be 2% versus 2021. We estimate the FX impact to full year sales at today's spot rate to be about $1.5 billion.

    現在轉向我們在幻燈片 16 上的 2022 年非 GAAP 指導。我們將今年的收入指導更新為約 460 億美元,這反映了美元對其他全球貨幣的大幅升值。排除貨幣影響,預計該業務的基本銷售額將比 2021 年增長 2%。我們估計,以今天的即期匯率計算,外匯對全年銷售額的影響約為 15 億美元。

  • We continue to expect our in-line and new product portfolio to grow in the low double-digit range and reaffirm our LOE guidance, including Revlimid's guidance of $9 billion to $9.5 billion for the year.

    我們繼續預計我們的在線和新產品組合將在低兩位數範圍內增長,並重申我們的 LOE 指導,包括 Revlimid 的全年指導,即 90 億美元至 95 億美元。

  • Gross margin is expected to be approximately 79%, up 100 basis points from previous guidance due to favorable impact of currency and related hedging settlements.

    由於貨幣和相關對沖結算的有利影響,毛利率預計約為 79%,比之前的指導高 100 個基點。

  • Our operating expense guidance, excluding acquired in-process R&D remained unchanged, declining in the low single digits versus prior year. This is primarily driven by favorability in FX as well as cost discipline. In terms of phasing for the second half of the year, we expect a more even phasing of expenses than in prior years.

    我們的運營費用指引(不包括獲得的進行中研發)保持不變,與去年相比下降了低個位數。這主要是由外匯市場的好感度以及成本紀律驅動的。就下半年的分階段而言,我們預計費用的分階段將比往年更加均衡。

  • All said, we are reaffirming our non-GAAP adjusted EPS guidance based on the underlying strength of our portfolio, mitigating currency translation from our natural hedges and hedging program.

    總而言之,我們正在根據我們投資組合的潛在實力重申我們的非公認會計原則調整後的每股收益指導,減少我們自然對沖和對沖計劃的貨幣轉換。

  • Before we move to Q&A, I just wanted to express my gratitude to all our colleagues around the world for continuing to deliver strong commercial, clinical and financial results. The resiliency of our company and exciting catalysts ahead make me energized by the growth opportunity ahead of us.

    在我們進行問答之前,我只想對我們在世界各地的所有同事繼續提供強大的商業、臨床和財務成果表示感謝。我們公司的彈性和未來令人興奮的催化劑使我對我們面前的增長機會充滿活力。

  • I'll now turn the call back over to Tim and Giovanni for Q&A.

    我現在將電話轉回給 Tim 和 Giovanni 進行問答。

  • Timothy Power - VP & Head of IR

    Timothy Power - VP & Head of IR

  • Thanks, David. Sarah, could we go to our first question, please?

    謝謝,大衛。莎拉,我們可以回答第一個問題嗎?

  • Operator

    Operator

  • (Operator Instructions) And we'll take our first caller from Chris Shibutani with Goldman Sachs.

    (操作員說明)我們將接聽來自高盛的 Chris Shibutani 的第一個來電。

  • Unidentified Analyst

    Unidentified Analyst

  • This is Dan on for Chris. Two from us. First on the milvexian readout. If you could maybe frame some areas of focus into the ESC data and provide any additional color into how you're thinking about the Phase III program as the data is in-house.

    這是克里斯的丹。我們兩個。首先是 milvexian 讀數。如果您可以將一些重點領域納入 ESC 數據中,並為您如何考慮第三階段計劃提供任何額外的顏色,因為數據是內部的。

  • And then second, on Camzyos, if there's any additional feedback you can provide on some of the early launch dynamics and your expectations into the second half of the year and early next year.

    其次,關於 Camzyos,如果您可以就一些早期發布動態以及您對下半年和明年初的期望提供任何額外的反饋。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Dan. Samit will answer your question on milvexian, and Chris, provide some incremental color on Camzyos. Thanks.

    謝謝你,丹。 Samit 將回答您關於 milvexian 的問題,而 Chris 將在 Camzyos 上提供一些增量顏色。謝謝。

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Sure. Thank you, Giovanni, and thank you, Dan, for the question on milvexian. Certainly looking forward to having the data presented at ESC and discussing the results. And of course, as you know, we'll go into the details with the other specifics of the data itself.

    當然。謝謝你,喬瓦尼,謝謝你,丹,關於 milvexian 的問題。當然期待在 ESC 上展示數據並討論結果。當然,如您所知,我們將詳細介紹數據本身的其他細節。

  • But I think there are 2 questions that probably are important to answer. Then we look at the data. And that would be, one, related to the efficacy, specifically when it comes to impact on clinically proven ischemic strokes. And the second, of course, is to look at bleeding rates, and more specifically, over there, one that physicians and patients would be interested to know about would be probably related to intracranial bleeds where patients with strokes have a propensity to have -- bleed as well as if there are any fatal bleeds. And so those are the kinds of questions that we set out to answer. And I think those are the questions that people will be very interested to know.

    但我認為有兩個問題可能很重要。然後我們看數據。這與療效有關,特別是對臨床證實的缺血性中風的影響。第二個,當然,是看出血率,更具體地說,在那裡,醫生和患者有興趣知道的可能與腦出血有關,腦卒中患者有這種傾向——流血以及是否有任何致命的流血。所以這些就是我們要回答的問題。我認為這些是人們非常有興趣知道的問題。

  • For Camzyos, let me pass it on to Chris to take you through.

    對於 Camzyos,讓我將其傳遞給 Chris 以帶您完成。

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • Thanks, Samit, and thanks, Dan, for the question. We are very pleased with the early launch of Camzyos. While it's still very early days, we're off to a very good start. And what I would say is that, by and large, the performance that we're seeing is aligned to our expectations. And I would highlight maybe 2 or 3 things.

    謝謝 Samit,謝謝 Dan 的提問。我們對 Camzyos 的提前推出感到非常高興。雖然現在還很早,但我們已經有了一個很好的開始。我想說的是,總的來說,我們所看到的表現符合我們的預期。我會強調兩三件事。

  • First, awareness is very good. We've seen incredibly strong enthusiasm for the product from both physicians and patients. Importantly, the feedback that we're getting on the clinical program has been overwhelmingly positive and consistent. I'm going to give you some vignette on that. Patients are seeing significant benefit, both in terms of feel and function. And that benefit is being seen very early, in fact, as early as 4 weeks post initiating treatment. And that's really important because it's driven a lot of enthusiasm, both from patients, and it's given physicians a reason to believe that the product is living up to the promise that we have.

    首先,意識非常好。我們已經看到醫生和患者對該產品的強烈熱情。重要的是,我們在臨床項目中獲得的反饋非常積極和一致。我會給你一些小插曲。患者在感覺和功能方面都看到了顯著的益處。事實上,早在開始治療後的 4 週就可以看到這種益處。這非常重要,因為它激發了患者的極大熱情,並且讓醫生有理由相信該產品正在兌現我們的承諾。

  • In terms of physician experience, the feedback has been very positive. The REMS education that we've initiated is intuitive. Getting on and certified for REMS has been straightforward. And as David mentioned, that's translated to over 1,400 HCPs being REMS-certified. And one thing I would highlight is that this is probably the most important leading indicator for this product launch. Given the fact that you don't have a history of REMS in the cardiovascular space, physicians are going to be REMS-certified if they have intent to use.

    就醫師經驗而言,反饋非常積極。我們發起的REMS教育是直觀的。獲得REMS並獲得認證非常簡單。正如大衛所說,這意味著超過 1,400 名 HCP 獲得了 REMS 認證。我要強調的一件事是,這可能是該產品發布的最重要的領先指標。鑑於您在心血管領域沒有 REMS 病史,如果醫生有意使用,他們將獲得 REMS 認證。

  • The last thing I would highlight is we're seeing a healthy increase in the number of centers prescribing week-over-week. We don't see any access issues on the horizon that would prevent these patients who are getting on to therapy converting to drug.

    我要強調的最後一件事是,我們看到每週開處方的中心數量健康地增加。我們沒有看到任何會阻止這些正在接受治療的患者轉變為藥物的訪問問題。

  • And so if I sum it up, performance is in line with expectations. We're happy with what we're seeing, and we very much look forward to the continued uptake of this product over the course of the year.

    因此,如果我總結一下,性能符合預期。我們對所看到的感到滿意,我們非常期待在這一年中繼續採用該產品。

  • Operator

    Operator

  • And next, we'll take Andrew Baum with Citi.

    接下來,我們將把 Andrew Baum 帶到花旗銀行。

  • Andrew Simon Baum - Global Head of Healthcare Research and MD

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • First question on milvexian. Is there any possibility you could expedite what's going to be a very large and long-duration clinical trial program through the adoption of MRI-defined silent strokes within a composite end point, either to expedite the trial or to decrease the (inaudible) required for the trials?

    關於milvexian的第一個問題。您是否有可能通過在復合終點內採用 MRI 定義的無聲中風來加快將要進行的非常大型和長期的臨床試驗計劃,以加快試驗或減少所需的(聽不清)審判?

  • Second, could you comment on whether you are exploring your CD19, CD3 -- or your CD19 CAR T, excuse me, Breyanzi, for autoimmune indications given some of the recent data in lupus.

    其次,您能否評論一下您是否正在探索您的 CD19、CD3 或您的 CD19 CAR T,對不起,Breyanzi,考慮到狼瘡的一些近期數據,用於自身免疫適應症。

  • And then finally, one of your competitors announced some intriguing data with an [AP-postulated] CTLA-4 in MSS colorectal cancer. I know that Bristol has one in, I think, Phase II. If you could provide us any update on that, that would be useful.

    最後,您的一個競爭對手公佈了一些有趣的數據,其中包括 [AP 假設的] CTLA-4 在 MSS 結直腸癌中的應用。我知道布里斯托爾有一個,我認為,第二階段。如果您可以向我們提供任何更新,那將很有用。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Andrew. I'll ask Samit to answer your 3 questions.

    謝謝你,安德魯。我會請 Samit 回答你的 3 個問題。

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Yes. Thank you, Giovanni, and thank you, Andrew. Very thoughtful questions, as always. For milvexian, look, we're not obviously going to get into the Phase III indications right now. But from a Phase II perspective, you will certainly get to see the data. And what is important is -- from a physician's perspective, what matters really is the clinical strokes, and those certainly will be the questions to discuss when the data are presented.

    是的。謝謝你,喬瓦尼,謝謝你,安德魯。非常周到的問題,一如既往。對於 milvexian,看,我們現在顯然不會進入 III 期適應症。但從第二階段的角度來看,你肯定會看到數據。重要的是——從醫生的角度來看,真正重要的是臨床中風,這些肯定是在提供數據時要討論的問題。

  • On the CD19 side, certainly very intriguing data in the autoimmune disease, especially in the [early-phase] SLE patients who are severely impacted by the disease. Those are the things that we continue to discuss from a scientific perspective, how to explore, where to explore and certainly not hidden from us. And as we evolve in our thinking, we'll share with everyone where we are going with that, the German data were very intriguing, I have to say, and as we presented earlier this year.

    在 CD19 方面,自身免疫性疾病的數據當然非常有趣,尤其是在受疾病嚴重影響的 [早期] SLE 患者中。這些是我們從科學的角度繼續討論的事情,如何探索,在哪裡探索,當然不會對我們隱藏。隨著我們思維的發展,我們將與每個人分享我們的目標,德國的數據非常有趣,我不得不說,正如我們今年早些時候介紹的那樣。

  • For CTLA-4, we've seen the data on CRC from a competitor. From our perspective, we have 3 CTLA-4 antibodies in development: the nonfucosylated, Probody as well as the nonfucosylated Probody. So there are 3 that are in development. The way we think about it is, number one, we have an ongoing study in MSS CRC for that, that we just initiated with Opdualag comparing to the standard of care. And for future developments for CTLA-4 antibodies, we have to think about combination strategies because we know that many a times even in the past, when single agents have been used, the response rates, ultimately in registration trials, have really been single digit or low single digits in fact.

    對於 CTLA-4,我們從競爭對手那裡看到了關於 CRC 的數據。從我們的角度來看,我們有 3 種 CTLA-4 抗體正在開發中:非岩藻糖基化的 Probody 以及非岩藻糖基化的 Probody。所以有3個正在開發中。我們的想法是,第一,我們在 MSS CRC 中正在進行一項研究,我們剛剛開始與 Opdualag 進行比較,與護理標准進行比較。對於 CTLA-4 抗體的未來發展,我們必須考慮組合策略,因為我們知道,即使在過去,很多時候,當使用單一藥物時,最終在註冊試驗中的反應率確實是個位數或實際上是低個位數。

  • So we will obviously be able to share the data once we have these combination studies completed. They are currently ongoing. Too early to talk about the data at this time. But certainly aware of the CRC data.

    因此,一旦我們完成了這些組合研究,我們顯然將能夠共享數據。他們目前正在進行中。現在談數據還為時過早。但肯定知道CRC數據。

  • Operator

    Operator

  • We'll take our next question from Geoff Meacham with Bank of America.

    我們將向美國銀行的 Geoff Meacham 提出下一個問題。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • I had a commercial one and a pipeline one. Chris, on Reblozyl, can you talk about the U.S. trends. What does duration of therapy look like today versus, say, a year ago? And does demand support upside for your peak forecast?

    我有一個商業的和一個管道的。克里斯,關於 Rebrozyl,你能談談美國的趨勢嗎?今天的治療時間與一年前相比如何?需求是否支持您的峰值預測?

  • And then Samit or Giovanni, I know Turning Point hasn't closed yet. But how much of a focus is I-O plus targeted therapy for Bristol looking forward? I know you ROS1 combos are probably more likely than not to come -- to play out in the pipeline. But beyond that, do you guys see this as sort of a new type of modality to sort of bolt on to an I-O strategy?

    然後是 Samit 或 Giovanni,我知道 Turning Point 還沒有結束。但是,I-O 加靶向治療對布里斯托爾的期待有多少關注點呢?我知道你們 ROS1 組合可能更有可能出現——在管道中發揮作用。但除此之外,你們是否認為這是一種新的模式來加強 I-O 策略?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Geoff. Chris, why don't you start on Reblozyl? And then Samit will comment on oncology strategy.

    謝謝你,傑夫。克里斯,你為什麼不從 Rebrozyl 開始?然後 Samit 將評論腫瘤學策略。

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • Yes. Thanks for the question, Geoff. We're very pleased with the continued uptake that we're seeing with Reblozyl. We had good growth in the quarter versus prior year as well as sequentially. I would highlight a few things.

    是的。謝謝你的問題,傑夫。我們對 Rebrozyl 的持續吸收感到非常高興。與去年同期相比,我們在本季度以及環比都有良好的增長。我要強調幾點。

  • First, we're continuing to see good acquisition of new patients for this product. One of the things that we look very carefully at is what are physicians' perceptions of the product and, importantly, how quickly they're moving patients off of ESAs to get on Reblozyl therapy. That time on ESAs when patients are not getting an adequate response continues to shorten, which is a leading indicator of the number of patients that will be within the indication that we have.

    首先,我們繼續看到該產品很好地獲得了新患者。我們非常仔細研究的一件事是醫生對產品的看法,重要的是,他們將患者從 ESA 轉移到 Rebrozyl 治療的速度有多快。當患者沒有得到足夠的反應時,在 ESA 上的時間繼續縮短,這是我們所擁有的適應症範圍內的患者數量的領先指標。

  • And importantly, we're seeing nice trends in both dosing and administration. The average MDS dose by cycle has grown steadily during the course of this launch and has increased this year. That's resulted in improved efficacy and longer duration of therapy, which, to your question, has been up 6% this year relative to where we were in 2021.

    重要的是,我們在劑量和給藥方面都看到了良好的趨勢。在本次發布期間,每個週期的平均 MDS 劑量穩步增長,並在今年有所增加。這提高了療效並延長了治療時間,根據您的問題,與 2021 年相比,今年的治療時間增加了 6%。

  • And while your question was mainly focused, I think, on the U.S., I would highlight that ex U.S., the launch is early. But we're seeing very good uptake in the early launch markets, notably markets like Germany. And then we'll have additional access and reimbursement decisions ex U.S.

    雖然您的問題主要集中在美國,但我想強調的是,在美國之前,發佈時間還早。但我們看到早期推出市場的吸收非常好,尤其是德國等市場。然後我們將在美國以外獲得額外的訪問權限和報銷決定。

  • So overall, we feel very good about where we are. And we look forward to continued uptake of this product as we go through the remainder of the year.

    所以總的來說,我們對自己所處的位置感覺很好。我們期待在今年剩下的時間裡繼續採用這種產品。

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • And thanks, Chris, and Geoff, maybe I can take on the Turning Point question. So first of all, excited about the acquisition of Turning Point Therapeutics and looking forward to bringing repotrectinib to patients in the second half of next year.

    謝謝,克里斯和傑夫,也許我可以回答轉折點問題。因此,首先對收購 Turning Point Therapeutics 感到興奮,並期待在明年下半年將 repotrectinib 帶給患者。

  • Your question around the combinations. Those are all going to be always data-dependent, and so explorations will continue. Although at this time, certainly, there is a lot of knowledge and lots of emergence of data, TKI combinations or tyrosine kinase inhibitors, which are not necessarily mutation-specific tyrosine [collagens], which have generated a lot of interest and a lot of data and have been approved in multiple indications when combined with I-O therapies, but it does provide additional opportunities in the future to look at these sorts of combinations and more specific prespecified populations and selected patient populations. But those will be data that will need to be generated at the current time. Too early to tell.

    你關於組合的問題。這些都將始終依賴於數據,因此探索將繼續。雖然在這個時候,當然,有很多知識和大量數據出現,TKI 組合或酪氨酸激酶抑製劑,不一定是突變特異性酪氨酸 [膠原蛋白],引起了很多興趣和很多數據,並且在與 I-O 療法相結合時已被批准用於多種適應症,但它確實為未來研究這些類型的組合以及更具體的預先指定的人群和選定的患者人群提供了額外的機會。但這些將是當前需要生成的數據。說得太早了。

  • Operator

    Operator

  • We'll take our next question from Chris Schott with JPMorgan.

    我們將向摩根大通的 Chris Schott 提出下一個問題。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • I guess the first one for me was on Breyanzi in terms of what's the latest on maybe the timing and, maybe as importantly, the magnitude of your capacity expansion. It sounds like this might have been getting pushed out into 2023 versus I think previously, you were talking about maybe a 4Q target. I just wanted to elaborate a bit more on what's happening there.

    我想對我來說第一個是關於 Breyanzi 的最新消息,也許是時間,也許同樣重要的是,你的產能擴張幅度。聽起來這可能會被推遲到 2023 年,而我之前認為,您可能在談論 4Q 目標。我只是想詳細說明那裡發生的事情。

  • And the second question was on Camzyos. I know there's a bit of a lag between when docs get certified for the REMS and when Bristol actually starts to generate sales for the drug. But as we just kind of think about the sales ramp from here, should we be thinking about this as a fairly gradual process? Or is this a product that could see a steeper ramp starting sometime later this year, given the 30-some identified kind of patients out there? I'm just trying to see in terms of expectation setting of how to think about the ramp given some of the, I guess, the promising initial data in terms of the number of physicians getting certified, et cetera.

    第二個問題是關於 Camzyos。我知道從醫生獲得 REMS 認證到布里斯托爾真正開始為該藥物帶來銷售之間存在一些滯後。但是,當我們只是考慮從這裡開始的銷售增長時,我們是否應該將其視為一個相當漸進的過程?或者,考慮到已經確定的 30 多位患者,這款產品是否會在今年晚些時候開始出現更陡峭的增長?我只是想看看如何考慮斜坡的期望設置,我猜,一些有希望的初始數據,如獲得認證的醫生數量等。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Chris. Chris?

    謝謝你,克里斯。克里斯?

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • Thanks for the question, Chris. On Breyanzi, what I would say just at the outset around cell therapy in general, is that the demand in the quarter for both of these products, Abecma and Breyanzi, was strong. We continue to be very pleased with the feedback on the profiles of these products and, importantly, how those profiles position us competitively.

    謝謝你的問題,克里斯。關於 Breyanzi,我一開始就圍繞細胞療法要說的是,本季度對這兩種產品 Abecma 和 Breyanzi 的需求都很強勁。我們繼續對有關這些產品配置文件的反饋感到非常滿意,更重要的是,這些配置文件如何使我們具有競爭力。

  • With respect to Breyanzi, as David mentioned earlier, we had underlying demand that was very strong. We're obviously very pleased with the second line approval and the fact that it's given us the broadest label of any CAR T in DLBCL. But as David also mentioned, sales were impacted in the quarter by manufacturing success rates. Those success rates, the issue underlying that was resolved, and we expect success rates to improve as we head into this quarter.

    關於 Breyanzi,正如大衛之前提到的,我們的潛在需求非常強勁。我們顯然對二線批准感到非常滿意,並且它為我們提供了 DLBCL 中任何 CAR T 中最廣泛的標籤。但正如大衛也提到的那樣,該季度的銷售受到製造成功率的影響。這些成功率,即已解決的潛在問題,我們預計隨著我們進入本季度,成功率將會提高。

  • More generally around manufacturing with Breyanzi, given the broader label, we had obviously hoped to have increased capacity in the second half of this year. We're now anticipating that in Q1 of 2023. Delivering that capacity is a top priority. The focus here is on increasing both vector and drug product supply. I will note that we've seen a nice increase in the capacity for Abecma, driven by successful drug product expansion and increasing vector supply, and we anticipate that, that same focus will be now applied to Breyanzi and have every expectation that we'll be able to deliver on that. That capacity is going to be important because given the broad label with this product and the compelling profile, slot availability is going to be critical. So the good news is we have a very strong manufacturing team focused on increasing the supply, and we look forward to delivering that supply in the first part of the year.

    更廣泛地說,在 Breyanzi 的製造方面,考慮到更廣泛的標籤,我們顯然希望在今年下半年增加產能。我們現在預計在 2023 年第一季度實現這一目標。提供這種能力是重中之重。這裡的重點是增加載體和藥品供應。我會注意到,在成功的藥物產品擴張和增加載體供應的推動下,我們已經看到 Abecma 的產能有了很好的增長,我們預計,同樣的重點現在將應用於 Breyanzi,並且完全期望我們會能夠實現這一點。這種容量將很重要,因為鑑於該產品的廣泛標籤和引人注目的配置,插槽可用性將至關重要。所以好消息是我們有一個非常強大的製造團隊,專注於增加供應,我們期待在今年上半年交付供應。

  • As for Camzyos and the pace of launch, I would view this as a steady increase in the number of patients. There are going to be 4 things that are really going to determine the pace of this launch: physician and patient demand, the volume of REMS-certified physicians, how quickly those patients come to get on Camzyos therapy and then, obviously, the conversion of those patients to commercial drug. And I would say really across all of those dimensions, we're happy with what we're seeing. And as I referenced earlier, it's in line with where we expected to be this early in the launch.

    至於 Camzyos 和推出的速度,我認為這是患者數量的穩步增長。將有 4 件事真正決定此次發布的速度:醫生和患者的需求、REMS 認證醫生的數量、這些患者接受 Camzyos 治療的速度,然後顯然是轉換那些病人要商業用藥。我想說的是,在所有這些方面,我們對我們所看到的感到滿意。正如我之前提到的,它符合我們在發布初期的預期。

  • As I mentioned earlier, the demand for the product is very strong. We're getting great feedback from both patients and physicians. I spoke to the volume of users and the fact that we're seeing a nice increase in the number of REMS-certified physicians every week. We had told you previously -- I think, in fact, last quarter that we expected patients to initiate therapy during their routine visits. And that's largely playing out. Though I would say, we've seen a number of accounts, including some of our smaller- and medium-sized accounts quickly getting multiple patients on the drug. We're also seeing some of our larger accounts organizing Camzyos clinic days so that they can efficiently bring larger volumes of patients, initiate them and monitor them. So again, that's where we thought it would be.

    正如我之前提到的,對該產品的需求非常強勁。我們從患者和醫生那裡得到了很好的反饋。我談到了用戶的數量,以及我們看到每週獲得 REMS 認證的醫生數量大幅增加的事實。我們之前已經告訴過你——我認為,事實上,上個季度我們預計患者會在他們的例行就診期間開始治療。這在很大程度上正在發揮作用。儘管我想說,我們已經看到了許多賬戶,包括我們的一些中小型賬戶,它們迅速讓多名患者服用該藥物。我們還看到我們的一些較大的客戶組織了 Camzyos 診所日,以便他們能夠有效地吸引更多的患者、啟動他們並監控他們。再說一次,這就是我們認為的地方。

  • And then finally, as I referenced earlier, access is going to be an important consideration here. Virtually, all oral specialty products like Camzyos go through this period of 2 to 6 months of getting on to formulary. During that period, the majority of patients are going to go on to free product. That's what we're seeing here. But again, the good news is we're not seeing any access issues. So we don't foresee any challenges converting those patients to commercial drug. So when you add it up, we expect the volume is going to increase over the course of the year. And then you'll see those patients convert to commercial sales as formulary status is achieved.

    最後,正如我之前提到的,訪問將是這裡的一個重要考慮因素。實際上,像 Camzyos 這樣的所有口腔專業產品都會經歷 2 到 6 個月的進入處方集的階段。在此期間,大多數患者將繼續免費產品。這就是我們在這裡看到的。但同樣,好消息是我們沒有看到任何訪問問題。因此,我們預計將這些患者轉變為商業藥物不會有任何挑戰。因此,當您將其加起來時,我們預計該數量將在一年中增加。然後您會看到這些患者在達到處方集狀態後轉為商業銷售。

  • But bottom line, we're very happy with what we're seeing thus far. Very much in line with expectations.

    但最重要的是,我們對迄今為止所看到的感到非常滿意。非常符合預期。

  • Operator

    Operator

  • We'll take our next call from Steve Scala with Cowen.

    我們將接聽 Steve Scala 和 Cowen 的下一個電話。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • A couple for Samit. First, in your deucravacitinib FDA discussions to date, has there been any mention of a box warning whatsoever? Or has that not come up in any conversation? And also given the time frame involved, can we assume there won't be an AdCom?

    薩米特的一對。首先,在迄今為止的 deucravacitinib FDA 討論中,有沒有提到任何警告框?還是在任何談話中都沒有提到這一點?並且考慮到所涉及的時間框架,我們可以假設不會有 AdCom 嗎?

  • And then the second question is based on available data. Does Bristol think other cardiac myosin inhibitors will have black box warning? Or do you think they could avoid that?

    然後第二個問題是基於現有數據。 Bristol 是否認為其他心臟肌球蛋白抑製劑會有黑框警告?或者你認為他們可以避免這種情況嗎?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Steve. Before I ask Samit to answer both of your questions, let me just say, as you know, we don't comment on ongoing discussion with regulatory authorities, but Samit will provide his perspective on both. Samit?

    謝謝你,史蒂夫。在我請 Samit 回答您的兩個問題之前,我只想說,如您所知,我們不對與監管機構正在進行的討論發表評論,但 Samit 將提供他對這兩個問題的看法。薩米特?

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Yes. Thank you. Steve, as Giovanni already mentioned, no specifics to be provided here. What I can repeat, I think, from the past conversations we've had is our confidence in the data itself for deucravacitinib when we think about from an efficacy perspective, differentiation and superiority that has been proven through the Phase III trial versus Otezla; from a safety perspective, showing differentiation when we think about the JAK inhibitors versus deucravacitinib, first-in-class TYK2 inhibitor. And this is that profile that has continued to evolve through multiple other trials that has given us the confidence to initiate the programs, as you know, in psoriatic arthritis, 2 Phase III trials ongoing, and also now looking forward to initiation of the SLE Phase III trials at the end of the year, beginning of next year. So overall, we're looking forward to September 10 PDUFA date and bringing this new medicine to patients.

    是的。謝謝你。史蒂夫,正如喬瓦尼已經提到的,這裡沒有提供任何細節。我認為,從我們過去的對話中,我可以重複的是,當我們從療效的角度、差異性和優勢考慮時,我們對 deucravacitinib 的數據本身充滿信心,這已通過 III 期試驗與 Otezla 的比較得到證明;從安全性的角度來看,當我們考慮 JAK 抑製劑與一流的 TYK2 抑製劑 deucravacitinib 時顯示出差異。這就是通過多項其他試驗不斷發展的概況,這使我們有信心啟動項目,如您所知,銀屑病關節炎正在進行 2 項 III 期試驗,現在也期待 SLE 階段的啟動三期試驗年底,明年初。所以總的來說,我們期待 9 月 10 日的 PDUFA 日期,並將這種新藥帶給患者。

  • In a similar way, I would say, in the cardiac myosin inhibitors, it is difficult and not appropriate probably for us to comment on other people's drug as to what a profile is going to look like and if they will have any warning and precautions in the label or not. What we can say though is, again, I believe in Camzyos as already alluded to by Chris as well and David in his remarks. Our belief in the data and how physicians how acting in terms of getting trained and prescribing it to the patients. So overall, looking forward to the initiation of our nonobstructive hypertrophic cardiomyopathy Phase III program towards the end of the year.

    以類似的方式,我會說,在心臟肌球蛋白抑製劑中,我們很難也可能不恰當地評論其他人的藥物配置文件的外觀以及他們是否會有任何警告和預防措施標籤與否。不過,我們可以說的是,我再次相信 Chris 和 David 在他的講話中已經提到的 Camzyos。我們對數據的信念以及醫生如何在接受培訓和給患者開處方方面如何行事。因此,總體而言,期待我們的非梗阻性肥厚性心肌病 III 期計劃在年底前啟動。

  • Operator

    Operator

  • We'll go on to Seamus Fernandez with Guggenheim.

    我們將與古根海姆一起去西莫斯費爾南德斯。

  • Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

    Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

  • So just a couple of quick questions. First off, this is really for Giovanni. Should Congress pass the Medicare pricing reform? Can you just help us understand what impacts you think this is likely to have, whether it be on innovation but also on your own long-term guidance from that perspective? And are you hopeful that there might be -- should this go through potential changes that could temper the impact, perhaps a pushout of this small molecule argument of 9 years of protection and perhaps maybe push that out to 12 or 13 years. Just wondering if there's -- there are any opportunities to think a little bit more constructively about this.

    所以只是幾個簡單的問題。首先,這真的是給喬瓦尼的。國會應該通過醫療保險定價改革嗎?您能否幫助我們了解您認為這可能產生的影響,無論是對創新還是對您自己從這個角度來看的長期指導?你是否希望可能會有 - 如果這經歷可能緩和影響的潛在變化,也許會推出這種 9 年保護期的小分子論點,也許會將其延長到 12 年或 13 年。只是想知道是否有機會對此進行更具建設性的思考。

  • And then separately, hoping to just get a little bit of color on the launch dynamics around deucravacitinib. You guys are commenting on your enthusiasm to kind of get this product to market and to patients. Just wanted to get a better sense of should the label actually have a JAK box warning, which we don't necessarily anticipate. But should that occur, what are you hearing from physicians with regard to the opportunity to kind of work around that? Maybe just as a clarifying question. We've gotten a lot of questions from investors on the possibility that if there were a JAK warning, could it actually be post biologic. Doesn't make a lot of sense to us. Just wondering where you guys stand on that proposal.

    然後分別,希望能對 deucravacitinib 的發布動態有所了解。你們正在評論你們將這種產品推向市場和患者的熱情。只是想更好地了解標籤是否真的有 JAK 框警告,我們不一定會預料到。但如果發生這種情況,您從醫生那裡聽到的關於有機會解決這個問題的信息是什麼?也許只是一個澄清的問題。我們從投資者那裡收到了很多問題,即如果有 JAK 警告,它實際上是否是生物後的。對我們來說沒有多大意義。只是想知道你們對那個提議的立場。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Seamus. Let me start on pricing reform, and then Chris will comment on deucravacitinib. So first of all, as you know, discussions are ongoing in Congress, and it's difficult to speculate exactly on the bill and some of the details. They will be included in the bill. There will also be obviously a long period during which implementation of some of the measures will be clarified and some of the dynamics would be really important to understand.

    謝謝你,西莫。讓我從定價改革開始,然後克里斯將評論 deucravacitinib。首先,如你所知,國會正在進行討論,很難準確推測該法案和一些細節。他們將被包括在賬單中。顯然,在很長一段時間內,一些措施的實施情況將得到澄清,其中一些動態對於理解是非常重要的。

  • So with respect to your question on would there be an impact to innovation. So first of all, we've consistently said that the elements of reform that improve affordability for patients, we are supportive of. And so as an example, the redesign of the Part D benefit and establishing another pocket cap for patients, that's very beneficial. And we are definitely very supportive of that.

    因此,關於您的問題,是否會對創新產生影響。因此,首先,我們一直表示,我們支持提高患者負擔能力的改革要素。舉個例子,重新設計 D 部分福利並為患者建立另一個口袋帽,這是非常有益的。我們絕對非常支持這一點。

  • There are elements in the bill, however, which are obviously very detrimental to innovation. And particularly, price setting by the government at 9 and 13 years, obviously, have the potential to have a negative impact on innovation overall. I would say that with respect to the impact for our company, there's 2 things I can say at this point. First of all, it's really not helpful to look at our exposure to the channel today. I think it's important to really understand the dynamics that will develop over the next few years before these policies are implemented.

    然而,該法案中的某些內容顯然對創新非常不利。尤其是政府在 9 年和 13 年的定價,顯然有可能對整體創新產生負面影響。我想說,關於對我們公司的影響,我現在可以說兩件事。首先,看看我們今天對頻道的曝光率真的沒有幫助。我認為在這些政策實施之前,真正了解未來幾年將發展的動態非常重要。

  • And a couple of things I'd like to say. First of all, obviously, as you know, Revlimid revenues in the U.S. are declining rapidly. Eliquis, we share that 50% with Pfizer. And then importantly, as you think about Opdivo, that loses exclusivity at the end of the decade.

    還有幾件事我想說。首先,顯然,如您所知,Revlimid 在美國的收入正在迅速下降。 Eliquis,我們與輝瑞分享了這 50%。然後重要的是,當你想到 Opdivo 時,它在本世紀末失去了排他性。

  • So what I can say is that our rapidly diversifying portfolio and a significant number of new medicines that we're launching today and would be launching before some key elements of this policy are implemented position us well to navigate the challenges associated with reform for the entire industry. But obviously, there is much more than we need to learn: first of all, through a potential finalization of the bill; and second, really understanding better some of the elements of its implementation.

    所以我能說的是,我們迅速多樣化的產品組合和我們今天推出的大量新藥,並將在該政策的一些關鍵要素實施之前推出,這使我們能夠很好地應對與整個改革相關的挑戰行業。但顯然,我們需要了解的遠不止這些:首先,通過可能的法案最終確定;其次,真正更好地理解其實施的一些要素。

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • So maybe I'll pick up, Seamus, on the question regarding deucravacitinib and the launch. So we're, as you know, very excited about the opportunity to launch this product. As was referenced previously, the commercial and medical teams are in place. They're ready to go. They're very experienced.

    所以也許我會接聽,Seamus,關於 deucravacitinib 和發布的問題。因此,如您所知,我們對有機會推出該產品感到非常興奮。如前所述,商業和醫療團隊已經到位。他們準備好了。他們非常有經驗。

  • What I've said previously, I think, is where we'll start this conversation, which is that we explore every meaningful scenario as we think about the launch of any new product, but we continue to index heavily on the scenario where we think that the preclinical and clinical data support, and that is that this is a unique mechanism of action that is clearly differentiated from other products in the class.

    我認為,我之前所說的是我們將開始這次對話的地方,即我們在考慮推出任何新產品時探索每一個有意義的場景,但我們繼續對我們認為的場景進行大量索引臨床前和臨床數據支持,即這是一種獨特的作用機制,與同類產品中的其他產品明顯不同。

  • And actually, when we talk to customers, we get an almost uniform alignment that that's the right way to think about deucravacitinib that the mechanism based on all of the data that we've seen is unique and it is differentiated. It's differentiated not only from JAKs, but it's differentiated, most importantly, from the current standard of care for oral agents treating moderate-to-severe patients. And so as we step back and think about this product, we anticipate very strong demand for deucravacitinib based on the clinical profile from 2 Phase III studies that show clear superiority relative to the existing standard of care. We have a unique mechanism of action that's clearly differentiated and, we think, positions us well to become the oral branded of choice for these moderate-to-severe psoriasis patients.

    實際上,當我們與客戶交談時,我們得到了幾乎一致的一致意見,這是思考 deucravacitinib 的正確方式,即基於我們所看到的所有數據的機制是獨一無二的並且是有區別的。它不僅不同於 JAK,而且最重要的是,它不同於目前治療中度至重度患者的口服藥物護理標準。因此,當我們退後一步考慮這個產品時,我們預計對 deucravacitinib 的需求將非常強勁,這基於 2 項 III 期研究的臨床概況,這些研究顯示出相對於現有護理標準的明顯優勢。我們有一種獨特的作用機制,這種機制明顯不同,我們認為,這使我們能夠很好地成為這些中度至重度銀屑病患者的首選口服品牌。

  • And as was implied in the premise of your question, we're very excited to launch this product. And we look forward to the PDUFA date in September.

    正如您問題的前提所暗示的那樣,我們很高興推出這款產品。我們期待 PDUFA 日期在 9 月。

  • Operator

    Operator

  • Next, we'll take Luisa Hector with Berenberg.

    接下來,我們將帶 Luisa Hector 和 Berenberg。

  • Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team

    Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team

  • You showed your slide on business development, highlighting the importance there. I just wanted to check. Has there been any shift in the activity, the trends in companies coming to you versus you approaching other companies? Just any more recent trends given the longer duration now of depressed valuations, just whether you're seeing any shift in those dialogues that you're having with targets.

    你展示了關於業務發展的幻燈片,強調了那裡的重要性。我只是想檢查一下。活動是否有任何變化,公司找你的趨勢與你找其他公司的趨勢有什麼不同嗎?鑑於現在估值低迷的持續時間較長,只是最近的趨勢,只是你是否看到與目標的對話有任何轉變。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thanks, Luisa. I would say nothing has changed there, continues to be an area of great focus for us. We're looking at bringing new science into the company. You are right, the valuations are resetting now for a longer period of time, and we plan on continuing to be very active in this field. It's always been a priority for us.

    謝謝,路易莎。我想說那裡沒有任何改變,仍然是我們非常關注的一個領域。我們正在考慮將新科學引入公司。你是對的,現在估值正在重新調整更長的時間,我們計劃繼續在這個領域非常活躍。這一直是我們的首要任務。

  • Operator

    Operator

  • We'll move on to Tim Anderson with Wolfe Research.

    我們將繼續討論沃爾夫研究公司的蒂姆安德森。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • I have a question on milvexian, which is historically, when companies have added together antiplatelet therapies or anticoagulant therapies to try to achieve better results, it pretty much always results in higher bleeding, and that calculation is whether that higher bleeding is more than offset by higher efficacy. So in SSP setting, just theoretically ignoring any data you already have at hand, shouldn't we expect that same sort of thing where we would likely see at least some additional bleeding and then we'd have to wait against efficacy? Or is it in the realm of possibilities that you really don't see any additional bleeding in that triple therapy arm?

    我有一個關於 milvexian 的問題,從歷史上看,當公司將抗血小板療法或抗凝劑療法結合在一起以試圖達到更好的效果時,它幾乎總是會導致更高的出血,而計算是更高的出血是否超過了更高的功效。因此,在 SSP 設置中,理論上忽略您手頭已有的任何數據,難道我們不應該期待同樣的事情,我們可能會看到至少一些額外的出血,然後我們不得不等待療效嗎?還是在這種可能性的範圍內,您真的看不到三聯療法組有任何額外的出血?

  • And then on TYK2, you guys expressed high confidence in the molecule. I'm wondering why you haven't advanced yet to mild-to-moderate patients. If you're fairly confident in the label, why not push ahead in Phase III and start to expand the market like Otezla has already done?

    然後在 TYK2 上,你們表達了對分子的高度信心。我想知道為什麼您還沒有發展到輕中度患者。如果你對這個標籤相當有信心,為什麼不像 Otezla 那樣在第三階段推進並開始擴大市場呢?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Tim. Let me just ask Samit to answer your question, both on milvexian and also plans for deucravacitinib.

    謝謝你,蒂姆。讓我請 Samit 回答您關於 milvexian 和 deucravacitinib 計劃的問題。

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Yes. Thank you. And certainly looking forward to, again, the presentation of the milvexian data. I obviously cannot get into specifics of the data itself. But let me just reiterate that the 2 questions that would be important from everybody's perspective is on the efficacy, looking at the clinical strokes. And secondly, from a bleed perspective, it becomes very important, what kind of bleed and especially when we think about the fatal bleed, intracranial bleed, meaning bleed that become important. If you look at the past, what you will see is those kinds of things that made people a little bit worried. So again, we can discuss more when we have the data presented at ESC around milvexian.

    是的。謝謝你。並且當然期待再次展示 milvexian 數據。我顯然無法深入了解數據本身的細節。但是讓我重申一下,從每個人的角度來看,兩個重要的問題是關於療效,看看臨床中風。其次,從出血的角度來看,它變得非常重要,什麼樣的出血,特別是當我們考慮致命出血時,顱內出血,意義出血變得重要。如果你回顧過去,你會看到那些讓人有點擔心的事情。因此,當我們在 ESC 上提供有關 milvexian 的數據時,我們可以進行更多討論。

  • On TYK2, certainly, we are very pleased with the profile for the oral TYK2 inhibitor that has obviously evolved and continues to evolve in multiple other indications as well. As we look to the mild-to-moderate psoriasis, as we've said before, we are looking to bring in the topical formulation, the Phase II trials that are about to begin from the Phase II -- or from the TYK2 perspective, and that's our foray into the mild-to-moderate psoriasis. As you know, the POETYK trial was conducted in a moderate-to-severe plaque psoriasis patients. And then, of course, multiple Phase III trials in various indications, first of all, in psoriatic arthritis that are ongoing and then SLEs starting later this year, and Phase II trials are ongoing in UC as well as in Crohn's disease.

    當然,在 TYK2 上,我們對口服 TYK2 抑製劑的概況感到非常滿意,該抑製劑已經明顯進化並繼續在多種其他適應症中進化。正如我們之前所說,當我們著眼於輕度至中度銀屑病時,我們正在尋求引入局部配方,即將從 II 期或從 TYK2 的角度開始的 II 期試驗,這就是我們對輕度至中度牛皮癬的嘗試。如您所知,POETYK 試驗是在中度至重度斑塊狀銀屑病患者中進行的。當然,還有針對各種適應症的多項 III 期試驗,首先是針對正在進行的銀屑病關節炎,然後是今年晚些時候開始的 SLE,以及針對 UC 和克羅恩病的 II 期試驗。

  • Operator

    Operator

  • We'll move on to Evan Seigerman with BMO.

    我們將繼續討論 BMO 的 Evan Seigerman。

  • Evan David Seigerman - MD & Senior BioPharma Research Analyst

    Evan David Seigerman - MD & Senior BioPharma Research Analyst

  • I want to talk on the kind of dynamics between Opdivo and Opdualag. Can you provide more color as to the split between patients who are switched from Opdivo to Opdualag?

    我想談談 Opdivo 和 Opdualag 之間的動態。您能否提供更多關於從 Opdivo 切換到 Opdualag 的患者之間的差異?

  • And then one on Turning Point. I know kind of the -- when you announced the deal, it was still kind of TBD on the pre-NDA discussions with FDA. Any update on that, that maybe will give us more confidence that you're able to launch in the second half of next year.

    然後是轉折點。我知道——當你宣布這筆交易時,與 FDA 的 NDA 前討論仍然是一種待定。對此的任何更新,可能會讓我們更有信心您能夠在明年下半年推出。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thanks, Evan. Let me just answer quickly your question on Turning Point before Chris addresses your Opdualag question.

    謝謝,埃文。在 Chris 回答您的 Opdualag 問題之前,讓我快速回答您關於 Turning Point 的問題。

  • So as you know, we continue to operate as 2 separate companies at the same time. As we've mentioned before, first of all, we remain confident in the ability to close in the third quarter of this year. And we're still looking at the launch of repo in the second half of next year. So all good there. Chris?

    如您所知,我們繼續同時作為兩家獨立的公司運營。正如我們之前提到的,首先,我們對今年第三季度結束的能力仍然充滿信心。我們仍在關註明年下半年推出回購協議。所以那裡一切都很好。克里斯?

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • Sure. So we're very pleased with where we are with the Opdualag approval and the early uptake. The execution of the team has been very strong, and physician reaction has been quite positive.

    當然。因此,我們對 Opdualag 的批准和早期採用感到非常滿意。團隊的執行力非常強,醫生的反應也相當積極。

  • In terms of the dynamics within the market, shares in first-line metastatic melanoma are in the low double digits for Opdualag. We have seen some early use in second-line-plus patients that's mainly driven by the fact that, remember, the flow of newly diagnosed metastatic melanoma patients can be somewhat staggered just given the volume of patients you have in this market. And so what we're seeing is not only are physicians using the product in first line, but they're also looking to use it in second line as patients either progress or they're willing to switch patients.

    就市場動態而言,Opdualag 在一線轉移性黑色素瘤中的份額處於兩位數的低位。我們已經在二線以上的患者中看到了一些早期使用,這主要是由於以下事實驅動的,記住,考慮到您在這個市場上的患者數量,新診斷的轉移性黑色素瘤患者的流量可能會有些交錯。因此,我們看到的不僅是醫生在一線使用該產品,而且他們還希望在患者進展或願意更換患者時將其用於二線。

  • In terms of who those patients are, that dynamic is playing out largely as expected. We're mostly displacing PD-1 monotherapy. That's to be expected, just given the strength of the clinical data with a more than 2x improvement in PFS and a strong trend towards overall survival relative to PD-1 monotherapy. We are seeing some modest conversion of Opdivo, Yervoy to Opdualag. But at this point, that's very much within the -- what we had expected.

    就這些患者是誰而言,這種動態在很大程度上正如預期的那樣發揮作用。我們主要是在取代 PD-1 單一療法。這是意料之中的,只是考慮到臨床數據的強度,PFS 提高了 2 倍以上,並且相對於 PD-1 單藥治療的總體存活率有很強的趨勢。我們看到 Opdivo、Yervoy 向 Opdualag 的一些適度轉換。但在這一點上,這非常符合我們的預期。

  • So overall, I would say Opdualag, first, the performance continues to be very good. It's early days, but certainly, we have strong momentum. And the interplay between dual I-O, single-agent I-O and Opdualag is largely as expected.

    所以總的來說,我會說 Opdualag,首先,性能仍然非常好。現在還為時尚早,但可以肯定的是,我們的勢頭強勁。雙 I-O、單代理 I-O 和 Opdualag 之間的相互作用在很大程度上符合預期。

  • Operator

    Operator

  • We'll take our next question from Terence Flynn with Morgan Stanley.

    我們將向摩根士丹利的特倫斯弗林提出下一個問題。

  • Terence C. Flynn - Equity Analyst

    Terence C. Flynn - Equity Analyst

  • Maybe Samit, as we think ahead to milvexian and the various Phase III opportunities, would just welcome your perspective on why the Xarelto COMPASS data didn't really change the treatment paradigm in patients with CAD/PAD. Again, I know you're not going to comment in terms of where you're going right now in terms of Phase III opportunities, but just trying to think about risk, benefit in some of these other populations where Eliquis hasn't really found much usage.

    也許 Samit,正如我們對 milvexian 和各種 III 期機會的看法一樣,會歡迎您對 Xarelto COMPASS 數據為何沒有真正改變 CAD/PAD 患者的治療模式的看法。再說一次,我知道您不會就第三階段機會方面的進展發表評論,而只是嘗試考慮風險,並在 Eliquis 尚未真正發現的其他一些人群中受益很多用法。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Terence. Samit?

    謝謝你,特倫斯。薩米特?

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Yes. Look, again, milvexian is a Factor XI inhibitor and the first of its kind. Certainly, there are others that are in development as well. So looking forward to the presentation of the data and then discussing the Phase III plans, which will be towards the end of this year, the initiation, as Giovanni mentioned in his comments early on.

    是的。再看一遍,milvexian 是一種因子 XI 抑製劑,並且是同類中的第一個。當然,還有其他正在開發中。因此,期待數據的呈現,然後討論第三階段計劃,這將在今年年底開始,正如喬瓦尼在他早些時候的評論中提到的那樣。

  • I obviously cannot comment on why Xarelto, but certainly, Eliquis with this indication, you've heard Chris and David mentioned early on as to what has been accomplished with Eliquis and continues to accomplish, very effective treatment. We are trying to solve the Factor XIa inhibitors, some of the shortcomings that have been left behind for -- from the Factor Xa inhibitors and especially -- and from the Phase II trial, we're looking at also the combination of it with dual antiplatelet therapies.

    我顯然無法評論為什麼 Xarelto,但可以肯定的是,有這個跡象的 Eliquis,你已經聽到 Chris 和 David 很早就提到 Eliquis 已經完成並繼續完成非常有效的治療。我們正在努力解決因子 XIa 抑製劑,一些被遺留下來的缺點——來自因子 Xa 抑製劑,尤其是——以及來自 II 期試驗,我們也在研究它與雙重的組合抗血小板治療。

  • So that's the overall intent for the future development to look at multiple other opportunities in the arterial as well as on the venous side for milvexian as a single agent as well as in the combination with the background therapy. So more to follow. And certainly, after the data presentation, we can have a wider dialogue on the indications and the plans.

    因此,未來發展的總體意圖是考慮將 milvexian 作為單一藥物以及與背景療法組合在動脈和靜脈方面的多種其他機會。所以更多的關注。當然,在數據展示之後,我們可以就適應症和計劃進行更廣泛的對話。

  • Operator

    Operator

  • We'll take our next caller from Matthew Phipps with William Blair.

    我們將接聽來自 Matthew Phipps 和 William Blair 的下一位來電者。

  • Matthew Christopher Phipps - Senior Biotechnology Research Analyst

    Matthew Christopher Phipps - Senior Biotechnology Research Analyst

  • Another melanoma landscape question. The results of DREAMseq were presented at the recent ASCO showing Opdivo, Yervoy maybe should be used even ahead of BRAF-inhibitor combinations. Do you think that's enough to drive more uptake of Opdivo and Yervoy in that setting in the front line? Or is this saying you're going to explore with additional trials, maybe newer CTLA-4 antibodies?

    另一個黑色素瘤景觀問題。 DREAMseq 的結果在最近的 ASCO 上展示了 Opdivo,Yervoy 甚至應該在 BRAF 抑製劑組合之前使用。你認為這足以在前線的環境中推動 Opdivo 和 Yervoy 的更多采用嗎?或者這是否是說您將通過其他試驗進行探索,也許是更新的 CTLA-4 抗體?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you. Chris?

    謝謝你。克里斯?

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • Sure. Well, thanks for the question, Matthew. We have long believed that I-O has promised in improving the outcome of BRAF-mutant positive patients. Today, as you may know, the use of I-O particularly as a first-line treatment in that population is still somewhat limited. It's around 30% to 35% of that population. The DREAMseq data that were presented actually last year at ASCO are potentially practice informing in that they provide, I think, important insights into how to best sequence dual I-O therapy relative to targeted therapy. And in particular, they show that the use of dual I-O before targeted TAF MEK therapy led to a significant improvement in -- to your overall survival.

    當然。好吧,謝謝你的問題,馬修。我們一直相信 I-O 有望改善 BRAF 突變陽性患者的預後。今天,您可能知道,在該人群中使用 I-O 特別是作為一線治療仍然有些有限。約佔該人口的 30% 到 35%。去年在 ASCO 上實際展示的 DREAMseq 數據可能會為實踐提供信息,因為我認為它們提供了關於如何最好地對雙 I-O 治療相對於靶向治療進行排序的重要見解。特別是,他們表明,在靶向 TAF MEK 治療之前使用雙 I-O 可以顯著提高您的總體生存率。

  • So in that regard, the data are compelling, and it can inform practice. The one big caveat to keep in mind here is that targeted therapy combination used for first-line BRAF-mutant patients has been very sticky. And so while we may see some use of dual I-O in the frontline setting based on DREAMseq, I would anticipate that would be mainly an academic setting, primarily because that's where the data are going to be most known. Remember, we can't promote to this data. So I think it's unlikely you're going to see broader adoption. That said, it's encouraging data, and it could have an impact on selected customers.

    所以在這方面,數據是令人信服的,它可以為實踐提供信息。這裡要記住的一個重要警告是,用於一線 BRAF 突變患者的靶向治療組合非常棘手。因此,雖然我們可能會在基於 DREAMseq 的一線環境中看到一些雙 I-O 的使用,但我預計這將主要是學術環境,主要是因為這是數據最廣為人知的地方。請記住,我們無法推廣到此數據。所以我認為你不太可能看到更廣泛的採用。也就是說,這是令人鼓舞的數據,它可能會對選定的客戶產生影響。

  • Operator

    Operator

  • We'll move on next to Carter Gould with Barclays.

    我們將繼續與 Barclays 一起在 Carter Gould 旁邊。

  • Carter Lewis Gould - Senior Analyst

    Carter Lewis Gould - Senior Analyst

  • Great. I wanted to go to Eliquis and exactly kind of what's -- which countries are baked into sort of the second half headwind. You mentioned the $250 million headwind on the quarter. You made some inter-quarter comments. And we've seen some additional countries have generics like Canada. And I guess, just bigger picture, is it more appropriate to still think about Eliquis as a tailwind to overall company growth in '23? Given some of these headwinds, it seems like every month, there's a new country sort of launching generics.

    偉大的。我想去 Eliquis,確切地說是什麼——哪些國家在下半年陷入了逆風。您提到了本季度 2.5 億美元的逆風。您發表了一些季度間評論。我們已經看到一些其他國家有仿製藥,比如加拿大。而且我想,從更大的角度來看,將 Eliquis 視為 23 年整體公司增長的順風是否更合適?鑑於其中一些不利因素,似乎每個月都有一種新的國家推出仿製藥。

  • And I guess then secondly, just on deucravacitinib, how are you guys thinking about those IBD indications right now and specifically sort of the viability of those higher doses and if anything is shifted based on your conversations with FDA around psoriasis?

    其次,我想,就德烏拉伐替尼而言,你們現在如何考慮這些 IBD 適應症,特別是那些更高劑量的可行性,以及根據你們與 FDA 關於銀屑病的對話是否有任何變化?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Let me just start on Eliquis, and then David will provide some more insight. And Chris answer your second question.

    讓我從 Eliquis 開始,然後 David 將提供更多見解。克里斯回答你的第二個問題。

  • So what's referred to by David in terms of the impact of EU generics for the rest of the year at this point is the U.K. and the Netherlands. So let me just step back and remind you where we are. In the U.K., as you know, the high courts had found our composition of (inaudible) to be invalid. And obviously, we strongly disagree with that ruling because that's the same patent that was actually upheld and reaffirmed in both the U.S. and Canada last year, and we're seeking permission to appeal.

    因此,David 提到的歐盟仿製藥對今年剩餘時間的影響是英國和荷蘭。所以讓我退後一步,提醒你我們在哪裡。如您所知,在英國,高等法院認定我們的(聽不清)構成無效。顯然,我們強烈不同意該裁決,因為這與去年在美國和加拿大實際上得到維護和重申的專利相同,我們正在尋求上訴許可。

  • The Netherlands is very different because in the Netherlands, generic company decided to launch before the trial actually took place on the merits. And obviously, that trial is still ongoing.

    荷蘭則大不相同,因為在荷蘭,仿製藥公司決定在試驗實際發生之前就推出了案情。顯然,該試驗仍在進行中。

  • There are generics of Eliquis that we expect to enter the market in Canada that was planned later this year. And as we've communicated before, there are similar lawsuits ongoing in other EU countries, and every country actually is completely independent. And each jurisdiction will make a decision independent. From our perspective, we continue to be very much convinced about the strength of our IP and will defend every case in every country. David?

    Eliquis 的仿製藥預計將在今年晚些時候進入加拿大市場。正如我們之前所傳達的,其他歐盟國家也有類似的訴訟正在進行,每個國家實際上都是完全獨立的。每個司法管轄區將獨立做出決定。從我們的角度來看,我們仍然非常相信我們知識產權的實力,並將為每個國家的每一個案件辯護。大衛?

  • David V. Elkins - Executive VP & CFO

    David V. Elkins - Executive VP & CFO

  • And Carter, also just recall, the vast majority of our growth comes from the U.S., and we have patent protection until April 1, 2028. So feel really strong about the growth potential -- continued growth potential of Eliquis by that.

    卡特也請回想一下,我們的絕大多數增長來自美國,並且我們在 2028 年 4 月 1 日之前享有專利保護。因此,對增長潛力感到非常強烈——Eliquis 的持續增長潛力由此而來。

  • But just to contextualize our business in the U.K. is about $500 million. And what we said is it will be about -- between the U.K. and the Netherlands, it will be about $250 million this year. And as Giovanni talked about in the other European markets, we'll continue to vigorously defend our intellectual property in there. And hopefully, that provides some context on how we're thinking about the growth potential of Eliquis despite this.

    但僅將我們在英國的業務背景化,大約需要 5 億美元。我們所說的是,在英國和荷蘭之間,今年將達到 2.5 億美元左右。正如喬瓦尼在其他歐洲市場所說的那樣,我們將繼續在那里大力捍衛我們的知識產權。希望這能為我們如何考慮 Eliquis 的增長潛力提供一些背景信息。

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • And then maybe I'll just say something very briefly on IBD and turn it over to Samit to talk about the development. IBD is obviously a large and underserved market. Some elements are more competitive than others, but in general, there's still a need for multiple oral options here. And given the profile that we've seen with deucrava, certainly through the psoriasis program, I think from a commercial standpoint, there would certainly be an intriguing opportunity for us. But Samit can speak more directly to the clinical plans.

    然後也許我會在 IBD 上簡單說幾句,然後交給 Samit 談論發展。 IBD 顯然是一個龐大且服務不足的市場。有些元素比其他元素更具競爭力,但總的來說,這裡仍然需要多種口頭選擇。鑑於我們在 deucrava 中看到的概況,當然是通過銀屑病計劃,我認為從商業角度來看,我們肯定會有一個有趣的機會。但 Samit 可以更直接地談論臨床計劃。

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Yes. So just to keep it very brief, that both trials are ongoing in Phase II right now: one in Crohn's disease, one in ulcerative colitis. And based on data, we will be making decisions on development as well as the doses. But I would say it has no bearing at all in terms of the approvability of the deucravacitinib in September for the psoriasis program. So rest assured that. Thank you.

    是的。因此,為了保持簡短,兩項試驗目前都在第二階段進行:一項針對克羅恩病,一項針對潰瘍性結腸炎。根據數據,我們將決定開發和劑量。但我想說,就 9 月 deucravacitinib 對銀屑病項目的批准而言,這完全沒有關係。所以放心吧。謝謝你。

  • Operator

    Operator

  • We'll move on next to Dane Leone with Raymond James.

    我們將與雷蒙德·詹姆斯一起在 Dane Leone 旁邊繼續前進。

  • Dane Vincent Leone - MD & Biotechnology Analyst

    Dane Vincent Leone - MD & Biotechnology Analyst

  • Two strategy ones for me, and this is something that comes up in almost every investor conversation. For you guys to win with milvexian, the view is that you really have to have that head-to-head comparative trial versus riva in AFib, and AFib is going to represent the majority of the addressable market for milvexian. And so the question is, from a lot of people's perspectives, from a time line, it seems like you guys might be behind there on that front. Could you just maybe address what your strategy is to get into AFib, what you view as the time lines for success and then, generally, how you view head-to-head trials is potentially mitigating the LOE associated with Eliquis as we go through this decade?

    對我來說,有兩個策略,這幾乎是每個投資者談話中都會提到的。為了讓你們與 milvexian 一起獲勝,我們的觀點是,您確實必須在 AFib 中與 riva 進行面對面的比較試驗,而 AFib 將代表 milvexian 的大部分潛在市場。所以問題是,從很多人的角度來看,從時間線來看,你們似乎在這方面可能落後。您能否談談您進入 AFib 的策略是什麼,您認為成功的時間線是什麼,然後,一般來說,您如何看待面對面試驗可能會在我們經歷此過程時減輕與 Eliquis 相關的 LOE十年?

  • And then kind of to the same point, there's a lot of questions of how you preserve the Opdivo revenues going forward and how much you can actually swap out with further studies of Opdualag. And you have a number of ongoing. But what do you really see as the potential of Opdualag peak sales from what you know now between what's going to cannibalize Opdivo and potentially Yervoy versus where are going to be de novo markets for pure growth?

    然後在同一點上,還有很多關於如何保持 Opdivo 收入的問題,以及你實際上可以通過對 Opdualag 的進一步研究來交換多少。而且你有一些正在進行的。但是,從您現在所知道的將蠶食 Opdivo 和潛在的 Yervoy 與將成為純增長的從頭市場之間的情況來看,您真正認為 Opdualag 銷售高峰的潛力是什麼?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you. Let me just answer your Opdualag question, first, and then Samit is best positioned to comment on milvexian.

    謝謝你。讓我先回答您的 Opdualag 問題,然後 Samit 最適合評論 milvexian。

  • So on Opdualag, as we've stated before, we see great potential for Opdualag. And as you look at -- and in fact, we've articulated our perspective that peak sales for the asset can be from a nonrisk-adjusted basis above $4 billion in revenue, and that, of course, comes from a number of indications. And when you look at the indications that we are currently studying, of course, melanoma is the entry for Opdualag, but there are trials ongoing in colorectal cancer, liver cancer and lung cancer. And in some cases, those are indications where we currently have a presence with Opdivo. In some cases, there are new indications. You are right that we look at Opdualag as an opportunity to provide durability to our I-O franchise. And assuming continued successful development, there is clearly a potential for Opdualag to be playing in a meaningful part of the current revenue space for Opdivo.

    因此,正如我們之前所說,在 Opdualag 上,我們看到了 Opdualag 的巨大潛力。正如你所看到的 - 事實上,我們已經闡明了我們的觀點,即資產的峰值銷售額可能來自超過 40 億美元的非風險調整基礎,當然,這來自許多跡象。當你看到我們目前正在研究的適應症時,當然,黑色素瘤是 Opdualag 的入口,但在結直腸癌、肝癌和肺癌方面正在進行試驗。在某些情況下,這表明我們目前在 Opdivo 有業務。在某些情況下,有新的跡象。您是對的,我們將 Opdualag 視為為我們的 I-O 特許經營權提供持久性的機會。假設繼續成功發展,Opdualag 顯然有可能在 Opdivo 目前的收入空間中發揮重要作用。

  • With respect to milvexian, again, Samit will comment. Let me just remind you that as he said before, we'll be able to provide much more insights into develop -- the development program once you've seen that we presented the data. And obviously, we're looking at a broad set of indications well beyond AFib. But Samit?

    關於 milvexian,Samit 將再次發表評論。讓我提醒您,正如他之前所說,一旦您看到我們提供了數據,我們將能夠提供更多關於開發的見解 - 開發計劃。顯然,我們正在研究一系列遠遠超出 AFib 的跡象。但是薩米特?

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Just very briefly. Thank you, Giovanni. What I would say is that there will be data presentation, both from the competitor molecule and ourselves at the same time at ESC. Neither of the 2 companies have started the Phase III program, and our partners, Janssen and BMS, we are, of course, looking forward to initiation of that program later this year, as I said earlier, both on the venous and arterial side of things, single-agent combinations. And then we'll be able to talk about the competitors as well. So thank you.

    只是非常簡短。謝謝你,喬瓦尼。我想說的是,在 ESC 將同時展示來自競爭對手分子和我們自己的數據。兩家公司都沒有啟動 III 期計劃,我們的合作夥伴楊森和 BMS,當然,正如我之前所說,我們期待在今年晚些時候啟動該計劃,無論是在靜脈還是動脈方面事物,單代理組合。然後我們也可以談論競爭對手。所以謝謝。

  • Operator

    Operator

  • We'll move on to Colin Bristow with UBS.

    我們將繼續與 UBS 一起討論 Colin Bristow。

  • Colin Nigel Bristow - Analyst

    Colin Nigel Bristow - Analyst

  • Congrats on the quarter. On mezigdomide, when should we expect to see the fourth-line update on this asset? And could you just walk us through the broader development plan and timing around this, please?

    祝賀本季度。在 mezigdomide 上,我們應該什麼時候看到該資產的第四行更新?您能否向我們介紹一下更廣泛的開發計劃和時間安排,好嗎?

  • And then maybe just a follow-up on business development. Just how should we think about this going forward in terms of your therapeutic areas or mechanisms of interest? And what are you now thinking as your sort of sweet spot for deal size?

    然後也許只是對業務發展的跟進。就您感興趣的治療領域或機製而言,我們應該如何考慮這一點?你現在認為什麼是交易規模的最佳選擇?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you. Samit?

    謝謝你。薩米特?

  • Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

    Samit Hirawat - Executive VP & Chief Medical Officer of Global Drug Development

  • Sure. I will start with mezigdomide. And certainly, the data that we presented already in single-agent and combination has been quite interesting and certainly very helpful in terms of thinking of longer-term development plan for mezigdomide. The data update will be, I think, at ASH or at the next press conference that we will be able to find for the ongoing single-arm, open-label study.

    當然。我將從mezigdomide開始。當然,我們已經在單劑和組合中提供的數據非常有趣,並且對於考慮 mezigdomide 的長期發展計劃當然非常有幫助。我認為,數據更新將在 ASH 或下一次新聞發布會上進行,我們將能夠為正在進行的單臂、開放標籤研究找到這些數據。

  • More importantly, as you have seen in this scorecard that was presented by Giovanni earlier, mezigdomide has 2 Phase III trials planned to start in the coming -- in 2023 to look at the combination of (inaudible) as well as to look at the combination in the (inaudible) comparison versus pomalidomide. So those 2 are the second-line-plus indications where mezigdomide is going to be tested, and we're looking forward to those initiations in 2022.

    更重要的是,正如您在 Giovanni 早些時候提出的這張記分卡中看到的那樣,mezigdomide 計劃在即將開始的 2 項 III 期試驗——在 2023 年查看(聽不清)的組合以及查看組合在(聽不清)與泊馬度胺的比較中。因此,這兩個是二線以上的跡象,將測試 mezigdomide,我們期待 2022 年的這些啟動。

  • I'll give it back to Giovanni for the BD question.

    我會把它還給 Giovanni 的 BD 問題。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • And from a BD perspective, what I can say is we remain size-agnostic. We have tremendous financial flexibility. What we look at is compelling science in areas that we know well and the opportunity to continue to further strengthen the outlook of the company in the second half of the decade and beyond and, obviously, do that through deals that generate value for patients and for shareholders.

    從 BD 的角度來看,我能說的是我們仍然與規模無關。我們擁有巨大的財務靈活性。我們看到的是在我們熟知的領域中引人注目的科學,以及在本世紀下半葉及以後繼續進一步加強公司前景的機會,顯然,通過為患者和為患者創造價值的交易來做到這一點股東。

  • Timothy Power - VP & Head of IR

    Timothy Power - VP & Head of IR

  • Great. I know we're running short on time. I think maybe it's time to squeeze 2 last ones and maybe go to the next one, please, Sarah.

    偉大的。我知道我們的時間不多了。莎拉,我想也許是時候擠掉最後兩個了,也許可以去下一個,拜託了。

  • Operator

    Operator

  • Absolutely. We'll take our next question from Mohit Bansal with Wells Fargo.

    絕對地。我們將向富國銀行的 Mohit Bansal 提出下一個問題。

  • Mohit Bansal - Senior Equity Analyst

    Mohit Bansal - Senior Equity Analyst

  • Maybe a question on -- another question on Camzyos. So when we spoke to cardiologists, there were some concerns raised by general cardiologists talking about ramps and how maybe only cardiomyopathy clinics, which [have] more patients, are better equipped to handle this. So one, is it true? And number two, like to what end Bristol can help make it easy for doctors? And the last one is like, do you know how -- what percentage of patient population is treated at specialty cardiomyopathy clinics?

    也許是關於Camzyos 的另一個問題。因此,當我們與心髒病專家交談時,普通心髒病專家提出了一些關於坡道的擔憂,以及如何可能只有擁有更多患者的心肌病診所才能更好地處理這個問題。所以一,是真的嗎?第二,布里斯托爾可以為醫生提供什麼幫助?最後一個是,你知道嗎——有多少百分比的患者在心肌病專科診所接受治療?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you. Chris?

    謝謝你。克里斯?

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • Sure. So with respect to the REMS and sort of how that's been received, as I mentioned earlier, the feedback on the REMS process has been very favorable from physicians. It's straightforward to get certified. We've spent a lot of time working with Samit's team before approval to make sure that the REMS program generally was intuitive and fit into how cardiologists generally treat patients. And so far, that work upfront as well as the education we've done is paying off.

    當然。因此,關於 REMS 及其接收方式,正如我之前提到的,醫生對 REMS 流程的反饋非常有利。獲得認證很簡單。在獲得批准之前,我們花了很多時間與 Samit 的團隊合作,以確保 REMS 程序總體上是直觀的,並且適合心髒病專家治療患者的一般方式。到目前為止,這項前期工作以及我們所做的教育正在得到回報。

  • Cardiologists are generally seeing it as not a barrier. In fact, the fact that we have seen a large number of medium and small clinics get not only REMS-certified but get patients onto therapy and, in many cases, get multiple patients on therapy is an indicator of the fact that the REMS program is, by and large, being seen as something that's very manageable for physicians and hasn't proven to be a barrier at all. Moreover, I think that the REMS program when we designed it was important to make sure that patients are initiated and initiated safely and monitored over the course of their disease. And that's exactly how this process is playing out at this point. So very happy with respect to what we're hearing playback from physicians on REMS.

    心髒病專家通常認為這不是障礙。事實上,我們已經看到大量中小型診所不僅獲得了 REMS 認證,而且讓患者接受治療,而且在許多情況下,讓多名患者接受治療,這表明 REMS 計劃是一個事實。 ,總的來說,被視為對醫生來說非常易於管理的東西,並且根本沒有被證明是一個障礙。此外,我認為當我們設計 REMS 計劃時,重要的是要確保患者在疾病過程中安全啟動和啟動並進行監測。這正是這個過程在這一點上的表現。對於我們在 REMS 上聽到醫生的回放,我們感到非常高興。

  • Timothy Power - VP & Head of IR

    Timothy Power - VP & Head of IR

  • Thanks, Chris. Sarah, could we get to our last question, please?

    謝謝,克里斯。莎拉,我們可以回答最後一個問題嗎?

  • Operator

    Operator

  • Yes. We will take our last question today from Robyn Karnauskas with Truist Securities.

    是的。今天,我們將回答 Truist Securities 的 Robyn Karnauskas 提出的最後一個問題。

  • Robyn Kay Shelton Karnauskas - Research Analyst

    Robyn Kay Shelton Karnauskas - Research Analyst

  • All right. So quickly on Breyanzi. I mean (inaudible) suggests still there's like a small fraction, maybe 20% of people eligible that can get the drug. So given that you have a really broad label, you're going into second line, how do you think you can improve this? What steps are you taking to improve the vein to vein or brain to vein time?

    好的。 Breyanzi 這麼快。我的意思是(聽不清)表明仍然有一小部分,可能有 20% 的符合條件的人可以獲得這種藥物。因此,鑑於您的標籤非常廣泛,您將進入第二線,您認為如何改進這一點?您正在採取哪些措施來改善靜脈到靜脈或腦到靜脈的時間?

  • And on deucrav, just a quick question there. For the moderate patients, how are you viewing -- how it will be positioned versus Dermavant or [Arcus'] drug? The TAM came in at a lower price, pretty clean safety profile. How are you viewing any step edits that might be required there?

    在 deucrav 上,只是一個簡單的問題。對於中度患者,您如何看待——與 Dermavant 或 [Arcus'] 藥物相比,它將如何定位? TAM 的價格較低,安全性非常好。您如何查看那裡可能需要的任何步驟編輯?

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Robyn. Chris?

    謝謝你,羅賓。克里斯?

  • Christopher S. Boerner - Executive VP & Chief Commercialization Officer

    Christopher S. Boerner - Executive VP & Chief Commercialization Officer

  • Sure. What I would say is that on Breyanzi, I think, in general, the focus that we've had continues to be on -- if your question is around continuing to improve on the manufacturing side, the focus there has been on making sure that we're really on 3 things.

    當然。我想說的是,關於 Breyanzi,我認為,總的來說,我們一直關注的焦點仍然是——如果你的問題是關於繼續改進製造方面,那麼重點一直是確保我們真的在做三件事。

  • First, on Breyanzi, you have to -- on cell therapy generally, you have to stay focused on operational issues. Obviously, we spoke about the issue that hit the success rates with this program in the quarter. But clearly that's going to be one area of focus for us. And as part of that, you obviously are continuing to stay focused on improving turnaround time, and that's a clear focus for the manufacturing team.

    首先,在 Breyanzi 上,你必須——一般來說,在細胞療法上,你必須專注於運營問題。顯然,我們在本季度談到了影響該計劃成功率的問題。但很明顯,這將是我們關注的一個領域。作為其中的一部分,您顯然將繼續專注於縮短周轉時間,這顯然是製造團隊的重點。

  • Above and beyond that, though, what I would say is most critical for us at this stage in the launch for both of Abecma and Breyanzi is to continue to be focused on vector supply and drug product supply, continue to increase that. We're working hard with health authorities to increase capacity on drug supply for Breyanzi at our existing facilities. We're also bringing on 2 state-of-the-art facilities in Devens, Massachusetts and at Leiden in the Netherlands that, I think, are going to be an important component of how we continue to expand the capacity for that product coming into the first part of next year.

    不過,除此之外,我想說的是,在 Abecma 和 Breyanzi 的啟動階段,對我們來說最關鍵的是繼續專注於載體供應和藥品供應,並繼續增加這一點。我們正在與衛生當局合作,以提高我們現有設施的 Breyanzi 藥物供應能力。我們還將在馬薩諸塞州德文斯和荷蘭萊頓引進 2 個最先進的設施,我認為這將成為我們如何繼續擴大該產品的產能的重要組成部分。明年上半年。

  • And then with respect to deucravacitinib, I think the focus, as we look at deucravacitinib, is, first and foremost, recognizing that the most important thing with this asset as you think about access generally is going to be the value story that you have to tell. And we have a very strong story to tell with deucravacitinib. As I mentioned earlier, we anticipate demand is going to be strong for this, also recognize that you have 2 Phase III studies that show head-to-head data against the current standard of care for the patients who are being treated with moderate-to-severe psoriasis. So we have a very strong story to tell with payers.

    然後關於 deucravacitinib,我認為重點是,當我們看 deucravacitinib 時,首先要認識到,當您考慮訪問時,該資產最重要的事情將是您必須了解的價值故事告訴。我們有一個非常強大的故事要講述 deucravacitinib。正如我之前提到的,我們預計對此的需求將會很強勁,同時也認識到您有 2 項 III 期研究顯示了與目前正在接受中度至中度治療的患者的護理標準的頭對頭數據- 嚴重的牛皮癬。因此,我們有一個非常強大的故事要與付款人講述。

  • And then in terms of those dynamics, I'm actually less concerned about competition with topicals and in particular because remember, a lot of topicals are going to stay on board as you move into oral therapies and psoriasis. So I think the dynamics that we're most looking at are, first, making sure that we provide very quick access for patients who have plans with open access. And as we talked about last quarter, in this market as opposed to other markets that we've talked about, many patients are covered by plans that will have open access at launch. And then obviously, we're going to have to continue to build volume in order to expand coverage for those plans that don't have open access at launch. And there, it's going to be all about driving volume and then leveraging that volume to get into a better access position over time.

    然後就這些動態而言,我實際上不太關心與外用藥物的競爭,特別是因為請記住,當你進入口服治療和牛皮癬時,很多外用藥物會留在船上。所以我認為我們最關注的動態是,首先,確保我們為有開放訪問計劃的患者提供非常快速的訪問。正如我們在上個季度談到的那樣,在這個市場中,與我們談到的其他市場不同,許多患者都被計劃覆蓋,這些計劃將在發佈時開放訪問。然後很明顯,我們將不得不繼續增加數量,以擴大那些在發佈時沒有開放訪問的計劃的覆蓋範圍。在那裡,一切都是為了提高音量,然後利用該音量隨著時間的推移進入更好的訪問位置。

  • Giovanni Caforio - Chairman of the Board & CEO

    Giovanni Caforio - Chairman of the Board & CEO

  • Thank you, Chris. And from my perspective, let me just say again that what we are hearing from physicians all the time is that they consider Breyanzi as the best-in-class CD19 in CAR T, and I look forward to the opportunity to have a significant increase in capacity at the beginning of next year, which will be important for us.

    謝謝你,克里斯。從我的角度來看,讓我再說一遍,我們一直從醫生那裡聽到的是,他們認為 Breyanzi 是 CAR T 中同類最佳的 CD19,我期待有機會顯著增加明年年初的產能,這對我們來說很重要。

  • Now more broadly, I want to thank all of you for participating in the call. This was a strong quarter for the company. We have good momentum with our in-line business. There are very positive dynamics with our new product portfolio, and that positions us well for the second half of the year, which again, will be very important for the company. I look forward to continuing to answer your questions, and our IR team will be available for any follow-up you have. So thanks again, and have a good day.

    現在更廣泛地說,我要感謝大家參加電話會議。這對公司來說是一個強勁的季度。我們的在線業務發展勢頭良好。我們的新產品組合有非常積極的動態,這使我們在下半年處於有利地位,這對公司來說也非常重要。我期待繼續回答您的問題,我們的 IR 團隊將隨時為您提供任何後續服務。所以再次感謝,祝你有美好的一天。

  • Operator

    Operator

  • Thank you. And that does conclude today's teleconference. We do appreciate your participation. At this time, you may now disconnect.

    謝謝你。這確實結束了今天的電話會議。我們非常感謝您的參與。此時,您現在可以斷開連接。