嬌生 (JNJ) 2023 Q1 法說會逐字稿

內容摘要

強生公司公佈了 2022 年第一季度的強勁業績,在其製藥和醫療技術業務增長的推動下,全球銷售額增長了 5.6%,達到 247 億美元。該公司上調了 2023 年全年的指引,並宣布將股息提高 5.3%。

該公司還討論了其膝關節產品和機器人技術領域的進展,以及其管理房顫的方法。一家製藥公司的高管表示有信心超過共識目標,並討論了一項比較他們的藥物 RYBREVANT 與 TAGRISSO 在治療非小細胞肺癌方面的研究進展。

另一家製藥公司的首席執行官更正了之前的聲明,並對他們第一季度的業績以及投資於確保 MedTech 和 Pharmaceuticals 未來的機會的潛力表示樂觀。該公司專注於各種類型癌症的聯合治療,並探索膀胱癌的潛在數據。

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 morning, and welcome to Johnson & Johnson's First Quarter 2023 Earnings Conference Call. (Operator Instructions) This call is being recorded. If anyone has any objections, you may disconnect at this time. (Operator Instructions) I will now turn the conference call over to Johnson & Johnson. You may begin.

    早上好,歡迎來到強生公司 2023 年第一季度收益電話會議。 (接線員說明)此通話正在錄音中。如果有人有異議,此時您可以斷開連接。 (操作員說明)我現在將電話會議轉交給強生公司。你可以開始了。

  • Jessica Moore - VP of IR

    Jessica Moore - VP of IR

  • Good morning. This is Jessica Moore, Vice President of Investor Relations for Johnson & Johnson. Welcome to our company's review of the 2023 first quarter business results and full year financial outlook.

    早上好。我是強生公司投資者關係副總裁傑西卡摩爾。歡迎閱讀我們公司對 2023 年第一季度經營業績和全年財務展望的回顧。

  • Joining me on today's call are Joe Wolk, Executive Vice President, Chief Financial Officer; and Ashley McEvoy, Executive Vice President, Worldwide Chairman of MedTech. Unfortunately, Jennifer Taubert, Executive Vice President, Worldwide Chairman of Pharmaceuticals, is not feeling well and is unable to join us today.

    和我一起參加今天電話會議的還有執行副總裁兼首席財務官 Joe Wolk; MedTech 執行副總裁兼全球主席 Ashley McEvoy。不幸的是,執行副總裁兼製藥全球主席 Jennifer Taubert 身體不適,今天無法加入我們。

  • A few logistics before we get into the details. As a reminder, you can find additional materials, including today's presentation and associated schedules, on the Investor Relations section of the Johnson & Johnson website at investor.jnj.com.

    在我們進入細節之前先了解一些物流。提醒一下,您可以在強生公司網站 investor.jnj.com 的投資者關係部分找到其他材料,包括今天的演示文稿和相關時間表。

  • Please note that today's meeting contains forward-looking statements regarding, among other things, the company's future operating and financial performance, product development, market position and business strategy and the anticipated separation of the company's Consumer Health business. You are cautioned not to rely on these forward-looking statements, which are based on current expectations of future events using the information available as of today's date and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.

    請注意,今天的會議包含有關公司未來經營和財務業績、產品開發、市場地位和業務戰略以及公司消費者健康業務的預期分離等方面的前瞻性陳述。請注意不要依賴這些前瞻性陳述,這些陳述基於使用截至今天日期可用的信息對未來事件的當前預期,並受到某些風險和不確定性的影響,這些風險和不確定性可能導致公司的實際結果與這些結果存在重大差異預計。

  • A description of these risks, uncertainties and other factors can be found in our SEC filings, including our 2022 Form 10-K, which is available at investor.jnj.com and on the SEC's website. Additionally, several of the products and compounds discussed today are being developed in collaboration with strategic partners or licensed from other companies. This slide acknowledges those relationships.

    這些風險、不確定性和其他因素的描述可以在我們提交給美國證券交易委員會的文件中找到,包括我們的 2022 年 10-K 表格,可以在 investor.jnj.com 和美國證券交易委員會的網站上找到。此外,今天討論的一些產品和化合物是與戰略合作夥伴合作開發的,或者是從其他公司獲得許可的。這張幻燈片確認了這些關係。

  • Moving to today's agenda, I will review the first quarter sales and P&L results for the corporation and highlights related to the 3 segments. Joe will then provide additional business and financial commentary before sharing an overview of our cash position, capital allocation priorities and updated guidance for 2023. The remaining time will be available for your questions. We anticipate the webcast will last approximately 60 minutes.

    轉到今天的議程,我將回顧公司第一季度的銷售和損益結果以及與 3 個部門相關的亮點。然後,Joe 將提供額外的業務和財務評論,然後分享我們的現金狀況、資本分配優先事項和 2023 年更新指南的概述。剩餘時間將用於回答您的問題。我們預計網絡廣播將持續大約 60 分鐘。

  • Now let's turn to our first quarter results. Worldwide sales were $24.7 billion for the first quarter of 2023, an increase of 5.6% versus the first quarter of 2022. Operational sales, which excludes the effect of translational currency, increased 9% as currency had a negative impact of 3.4 points.

    現在讓我們來看看我們的第一季度業績。 2023 年第一季度全球銷售額為 247 億美元,比 2022 年第一季度增長 5.6%。排除換算貨幣影響後的營業銷售額增長 9%,因為貨幣帶來了 3.4 個百分點的負面影響。

  • In the U.S., sales increased 9.7%. In regions outside the U.S., our reported sales increased 1.8%. Operational sales outside the U.S. increased 8.3% with currency negatively impacting our reported OUS results by 6.5 points. Excluding the net impact of acquisitions and divestitures, adjusted operational sales growth was 7.6% worldwide, 7.4% in the U.S. and 7.9% outside the U.S. with all 3 segments growing sequentially over the fourth quarter.

    在美國,銷售額增長了 9.7%。在美國以外的地區,我們報告的銷售額增長了 1.8%。美國以外的營業銷售額增長了 8.3%,匯率對我們報告的 OUS 結果產生了 6.5 個百分點的負面影響。排除收購和資產剝離的淨影響,調整後的運營銷售額在全球範圍內增長 7.6%,在美國增長 7.4%,在美國以外增長 7.9%,所有 3 個部門在第四季度都實現了連續增長。

  • Turning now to earnings. For the quarter, net loss was $68 million, and basic loss per share was $0.03 versus diluted earnings per share of $1.93 1 year ago primarily driven by the $6.9 billion charge related to the talc settlement proposal. Excluding after-tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $7.1 billion, and adjusted diluted earnings per share was $2.68, representing a decrease of 0.9% and an increase of 0.4%, respectively, compared to the first quarter of 2022. On an operational basis, adjusted diluted earnings per share increased 3%.

    現在轉向收益。本季度淨虧損為 6800 萬美元,每股基本虧損為 0.03 美元,而一年前的稀釋後每股收益為 1.93 美元,主要原因是與滑石結算提案相關的 69 億美元費用。剔除稅後無形資產攤銷費用和特殊項目後,本季度調整後淨收益為 71 億美元,調整後攤薄每股收益為 2.68 美元,分別下降 0.9% 和上升 0.4%,相比之下到 2022 年第一季度。在運營基礎上,調整後的攤薄每股收益增長了 3%。

  • I will now comment on business segment sales performance highlights for the quarter. Unless otherwise stated, percentages quoted represent the operational sales change in comparison to the first quarter of 2022 and therefore, exclude the impact of currency translation.

    我現在將評論本季度業務部門的銷售業績亮點。除非另有說明,否則所引用的百分比表示與 2022 年第一季度相比的營業銷售額變化,因此不包括貨幣換算的影響。

  • Beginning with Consumer Health. Worldwide Consumer Health sales of $3.9 billion increased 7.4% with an increase of 11.4% in the U.S. and an increase of 4.4% outside the U.S. Worldwide operational sales increased 11.3%. And outside the U.S., operational sales increased 11.3%. Results were primarily driven by global strategic price increases across all franchises.

    從消費者健康開始。全球消費者保健品銷售額為 39 億美元,增長 7.4%,其中美國增長 11.4%,美國以外地區增長 4.4%。全球運營銷售額增長 11.3%。在美國以外,營業銷售額增長了 11.3%。結果主要是由所有特許經營權的全球戰略價格上漲推動的。

  • Volume growth in OTC was due to an exceptionally strong cough, cold and flu season most pronounced in Europe coupled with some onetime retailer restocking primarily in the U.S. related to low inventory levels due to tripledemic demand. Skin Health/Beauty delivered double-digit growth driven by price actions lapping prior year supply constraints and current quarter restocking as well as strong NEUTROGENA and AVEENO e-commerce and club channel performance and new product innovations.

    場外交易的銷量增長是由於咳嗽、感冒和流感季節在歐洲最為明顯,再加上一些曾經的零售商主要在美國補貨,這與三次需求導致的低庫存水平有關。皮膚健康/美容業務實現了兩位數的增長,這得益於去年供應限制和本季度補貨的價格走勢,以及強勁的 NEUTROGENA 和 AVEENO 電子商務和俱樂部渠道表現以及新產品創新。

  • Moving on to our Pharmaceutical segment. Worldwide Pharmaceutical sales of $13.4 billion increased 4.2% with growth of 5.9% in the U.S. and 2.4% outside of the U.S. Worldwide operational sales increased 7.2%. And outside the U.S., operational sales increased 8.6%. Excluding the COVID-19 vaccine sales, worldwide operational sales increased 4.9%. U.S. operational sales increased 7.1%, and outside the U.S., operational sales increased 2.4%.

    繼續我們的製藥部門。全球醫藥銷售額為 134 億美元,增長 4.2%,其中美國增長 5.9%,美國以外增長 2.4%。全球運營銷售額增長 7.2%。在美國以外,營業銷售額增長了 8.6%。不包括 COVID-19 疫苗銷售,全球運營銷售額增長 4.9%。美國營業銷售額增長 7.1%,美國以外的營業銷售額增長 2.4%。

  • Pharmaceutical growth excluding the COVID-19 vaccine was driven by our key brands and continued uptake in our recently launched products with 8 assets delivering double-digit growth. We continue to drive strong sales growth for both DARZALEX and ERLEADA with increases of 25.7% and 40.3%, respectively.

    不包括 COVID-19 疫苗在內的藥物增長是由我們的主要品牌推動的,並且我們最近推出的產品繼續採用,其中 8 項資產實現了兩位數的增長。我們繼續推動 DARZARLEX 和 ERLEADA 的強勁銷售增長,分別增長 25.7% 和 40.3%。

  • STELARA grew 9.6% driven by market growth and share gains in Crohn's disease and ulcerative colitis with gains of 2.2 points and 4.8 points in the U.S., respectively, partially offset by unfavorable patient mix and price. TREMFYA grew 11% driven by market growth and share gains in psoriasis and psoriatic arthritis with gains of 0.9 points and 2.1 points in the U.S., respectively, partially offset by unfavorable patient mix.

    STELARA 在克羅恩病和潰瘍性結腸炎市場增長和份額增長的推動下增長了 9.6%,在美國分別增長了 2.2 個百分點和 4.8 個百分點,部分被不利的患者組合和價格所抵消。受牛皮癬和銀屑病關節炎市場增長和份額增長的推動,TREMFYA 增長了 11%,在美國分別增長了 0.9 點和 2.1 點,部分被不利的患者組合所抵消。

  • Turning to newly launched products. We are excited to disclose CARVYKTI and SPRAVATO sales for the first time this quarter. We continue to make progress on our thoughtful and phased launch of CARVYKTI and continue to expand access and reimbursement for SPRAVATO. Also, we are encouraged by the early success of our launch of TECVAYLI, sales of which are included in other oncology.

    轉向新推出的產品。我們很高興在本季度首次披露 CARVYKTI 和 SPRAVATO 的銷售額。我們繼續在深思熟慮和分階段推出 CARVYKTI 方面取得進展,並繼續擴大 SPRAVATO 的准入和報銷。此外,我們對 TECVAYLI 推出的早期成功感到鼓舞,其銷售額包含在其他腫瘤學中。

  • This sales growth was partially offset by the loss of exclusivity in REMICADE and ZYTIGA, along with a decrease in IMBRUVICA sales due to competitive pressures. IMBRUVICA maintains its market leadership position worldwide.

    這一銷售增長部分被 REMICADE 和 ZYTIGA 失去獨家經營權以及 IMBRUVICA 銷售因競爭壓力而下降所抵消。 IMBRUVICA 保持其全球市場領導地位。

  • I'll now turn your attention to the MedTech segment. Worldwide MedTech sales of $7.5 billion increased by 7.3% with growth of 16.6% in the U.S. and a decline of 0.6% outside of the U.S.

    我現在將你的注意力轉向 MedTech 部分。全球醫療科技銷售額為 75 億美元,增長 7.3%,其中美國增長 16.6%,美國以外地區下降 0.6%。

  • Worldwide operational sales increased 11%. And outside the U.S., operational sales increased 6.2%.

    全球運營銷售額增長了 11%。在美國以外,營業銷售額增長了 6.2%。

  • Abiomed contributed 4.6% to operational growth. Excluding the impact of acquisition and divestitures, worldwide adjusted operational sales growth was 6.4%.

    Abiomed 為運營增長貢獻了 4.6%。排除收購和資產剝離的影響,全球調整後的運營銷售額增長率為 6.4%。

  • Sales in the first quarter accelerated sequentially from Q4 for all 4 MedTech businesses driven by global procedure growth, continued uptake of recently launched products and commercial execution. As anticipated, in China, procedure volumes improved as the quarter progressed. Partially offsetting growth in the quarter was the impact of volume-based procurement in China as well as supply constraints.

    受全球程序增長、最近推出的產品的持續採用和商業執行的推動,第一季度的銷售額從第四季度開始連續加速增長。正如預期的那樣,在中國,隨著本季度的進展,手術量有所增加。中國批量採購的影響以及供應限制部分抵消了本季度的增長。

  • The Interventional Solutions franchise delivered operational growth of 41.9%, which includes $324 million related to Abiomed. We are excited about the progress of the integration to which Joe will provide additional context. Excluding the impact of the acquisition, this franchise delivered another quarter of double-digit worldwide growth at 12.3%.

    Interventional Solutions 特許經營業務實現了 41.9% 的運營增長,其中包括與 Abiomed 相關的 3.24 億美元。我們對集成的進展感到興奮,Joe 將為其提供額外的背景信息。排除收購的影響,該特許經營權在全球範圍內實現了另外四分之一的兩位數增長,增長率為 12.3%。

  • As we continue to increase our reporting transparency, beginning this quarter, we are providing visibility to electrophysiology sales. Electrophysiology continued to deliver double-digit sales growth in all regions with the exception of Asia Pacific, which reflects impacts related to volume-based procurement in China.

    隨著我們繼續提高報告透明度,從本季度開始,我們將提供電生理學銷售的可見性。電生理學繼續在除亞太地區以外的所有地區實現兩位數的銷售增長,這反映了與中國批量採購相關的影響。

  • Orthopaedics operational growth of 5.1% reflects the strong procedure recovery and success of recently launched products especially digital and enabling technologies driving pull-through sales in areas like hips and knees. Growth was partially offset by the impact of volume-based procurement in China, primarily in hips and spine.

    骨科業務增長 5.1%,反映出強勁的手術恢復和最近推出的產品的成功,尤其是數字和支持技術推動了臀部和膝蓋等領域的銷售。增長部分被中國批量採購的影響所抵消,主要是在臀部和脊柱。

  • Global growth of 9.3% in contact lens and other reflects continued penetration of our ACUVUE OASYS 1-Day family of products, including the recent launch of ACUVUE OASYS MAX 1-Day, strong commercial execution and strategic price actions. Growth in contact lens and U.S. surgical vision was tempered by continued supply challenges.

    隱形眼鏡和其他產品的全球增長 9.3% 反映了我們 ACUVUE OASYS 1 天系列產品的持續滲透,包括最近推出的 ACUVUE OASYS MAX 1 天、強大的商業執行力和戰略價格行動。持續的供應挑戰抑制了隱形眼鏡和美國手術視力的增長。

  • Now turning to our consolidated statement of earnings for the first quarter of 2023. I'd like to highlight a few noteworthy items that have changed compared to the same quarter of last year. Cost of products sold deleveraged by 150 basis points driven by onetime COVID-19 vaccine manufacturing exit-related costs in the Pharmaceutical business and commodity inflation and acquisition-related items in the MedTech business.

    現在轉向我們 2023 年第一季度的綜合收益表。我想強調一些與去年同期相比發生變化的值得注意的項目。受製藥業務中一度與 COVID-19 疫苗製造退出相關的成本以及醫療技術業務中的商品通脹和收購相關項目的推動,銷售產品的成本去槓桿化了 150 個基點。

  • Selling, marketing and administrative margins leveraged by 60 basis points driven by proactive management of costs given the current inflationary environment. We continue to invest strategically in research and development at competitive levels, investing 14.4% of sales this quarter. The $3.6 billion invested was a 2.9% increase versus the prior year.

    鑑於當前的通貨膨脹環境,在主動成本管理的推動下,銷售、營銷和行政利潤率提高了 60 個基點。我們繼續在競爭水平上對研發進行戰略投資,本季度投資佔銷售額的 14.4%。投資額為 36 億美元,較上年增長 2.9%。

  • The other income and expense line was an expense of $7.2 billion in the first quarter of 2023 compared to net income of $100 million in the first quarter of 2022. The increase in expense was the result of the $6.9 billion charge related to the talc settlement proposal recorded in the first quarter of 2023 as previously disclosed.

    其他收入和支出項目在 2023 年第一季度的支出為 72 億美元,而 2022 年第一季度的淨收入為 1 億美元。支出增加的原因是與滑石結算提案相關的 69 億美元費用如前所述,記錄在 2023 年第一季度。

  • Regarding taxes in the quarter, our effective tax rate was 90.8% versus 12.2% in the same period last year primarily driven by the $6.9 billion accrual for the talc settlement proposal. Excluding special items, the effective tax rate was 16.5% versus 13.3% in the same period last year. I encourage you to review our upcoming first quarter 10-Q filing for additional details on specific tax matters.

    關於本季度的稅收,我們的有效稅率為 90.8%,而去年同期為 12.2%,這主要是受滑石結算提案的 69 億美元應計收入的推動。扣除特殊項目,實際稅率為 16.5%,去年同期為 13.3%。我鼓勵您查看我們即將發布的第一季度 10-Q 文件,了解有關特定稅務事項的更多詳細信息。

  • Lastly, I'll direct your attention to the boxed section of the slide, where we have also provided our income before tax, net earnings and earnings per share adjusted to exclude the impact of intangible amortization expense and special items.

    最後,請注意幻燈片的方框部分,我們還提供了稅前收入、淨收益和調整後的每股收益,以排除無形攤銷費用和特殊項目的影響。

  • Now let's look at the adjusted income before tax by segment. In the first quarter of 2023, our adjusted income before tax for the enterprise as a percentage of sales decreased from 35.1% to 34.2%. Pharmaceutical margins declined from 44.1% to 43.2% driven primarily by mix, partially offset by proactive management of costs. MedTech margins remained flat at 27% driven primarily by inflationary impacts, offset by proactive management of costs. Finally, Consumer Health margins improved from 22.1% to 22.3% driven primarily by strategic price actions, partially offset by input cost inflation.

    現在讓我們按部門查看調整後的稅前收入。 2023 年第一季度,我們調整後的企業稅前收入佔銷售額的比例從 35.1% 下降到 34.2%。製藥利潤率從 44.1% 下降到 43.2%,這主要是由於產品組合的原因,部分被積極的成本管理所抵消。 MedTech 的利潤率持平於 27%,這主要是受通貨膨脹影響的推動,但被積極的成本管理所抵消。最後,消費者健康業務的利潤率從 22.1% 提高到 22.3%,主要受戰略價格行動的推動,部分被投入成本通脹所抵消。

  • This concludes the sales and earnings portion of the Johnson & Johnson first quarter 2023 results. I am now pleased to turn the call over to Joe Wolk. Joe?

    強生公司 2023 年第一季度業績的銷售和收益部分到此結束。我現在很高興將電話轉給 Joe Wolk。喬?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Thank you, Jess, and thank you all for joining today's call. We are pleased to report another quarter of strong operational performance across our business. The results reflect the strength and versatility of Johnson & Johnson and our commitment to improving health care outcomes around the world.

    謝謝 Jess,也感謝大家參加今天的電話會議。我們很高興地報告我們業務又一個季度的強勁運營業績。這些結果反映了 Johnson & Johnson 的實力和多才多藝以及我們對改善全球醫療保健成果的承諾。

  • 2023 has many important catalysts that can drive meaningful near- and long-term value for Johnson & Johnson shareholders. We remain focused on the successful separation of our Consumer Health business, Kenvue, which will position both companies to be more agile, focused and competitive. We are also expecting a number of pipeline advancements that will provide increased confidence in our Pharmaceutical and MedTech businesses.

    2023 年有許多重要的催化劑可以為強生股東帶來有意義的近期和長期價值。我們仍然專注於我們的消費者健康業務 Kenvue 的成功分離,這將使兩家公司更加敏捷、專注和更具競爭力。我們還期待一系列管道改進,這將增強我們對製藥和 MedTech 業務的信心。

  • Our Pharmaceutical segment delivered a strong first quarter. Growth from our Pharmaceutical business continues to be driven by key assets in our existing portfolio, including DARZALEX, TREMFYA, ERLEADA, INVEGA SUSTENNA and UPTRAVI as well as uptake from new launches such as SPRAVATO, CARVYKTI and TECVAYLI.

    我們的製藥部門第一季度表現強勁。我們製藥業務的增長繼續受到我們現有產品組合中的關鍵資產的推動,包括 DARZARLEX 、 TREMFYA 、 ERLEADA 、 INVEGA SUSTENNA 和 UPTRAVI 以及 SPRAVATO 、 CARVYKTI 和 TECVAYLI 等新產品的吸收。

  • 2023 is an important year of scientific innovation for our Pharmaceutical business. And in Q1, we announced that CARVYKTI, our BCMA cell therapy, met its primary endpoint in the CARTITUDE-4 study, a Phase III trial in multiple myeloma patients who have received 1 to 3 prior lines of therapy. We look forward to presenting these results in an upcoming major medical meeting.

    2023年是我們醫藥事業科技創新的重要一年。在第一季度,我們宣布我們的 BCMA 細胞療法 CARVYKTI 在 CARTITUDE-4 研究中達到了主要終點,這是一項針對已接受 1 至 3 線治療的多發性骨髓瘤患者的 III 期試驗。我們期待在即將召開的大型醫學會議上展示這些結果。

  • Additionally, our partners at Protagonist Therapeutics announced positive top line results from the Phase IIb Frontier 1 study of our oral IL-23 in patients with moderate to severe plaque psoriasis. We look forward to sharing this data and future development plans at an upcoming medical meeting.

    此外,我們在 Protagonist Therapeutics 的合作夥伴宣布了我們在中度至重度斑塊狀銀屑病患者中口服 IL-23 的 IIb 期 Frontier 1 研究的積極頂線結果。我們期待在即將舉行的醫學會議上分享這些數據和未來的發展計劃。

  • Finally, as we continually review our portfolio to prioritize the most transformational assets for ongoing investment and an assessment of the RSV vaccine landscape, the company made the decision to discontinue its investigational RSV adult vaccine program. This decision is part of a broader effort to make strategic choices for our pipeline and R&D investments to focus on medicines with the greatest potential benefit to patients.

    最後,隨著我們不斷審查我們的投資組合以優先考慮最具變革性的資產進行持續投資和對 RSV 疫苗前景的評估,該公司決定停止其研究性 RSV 成人疫苗計劃。這一決定是為我們的管道和研發投資做出戰略選擇的更廣泛努力的一部分,以專注於為患者帶來最大潛在利益的藥物。

  • Looking at the rest of the year, we expect important data from key pipeline assets such as Nipocalimab and TREMFYA as well as the potential approval of Talquetamab. Importantly, I want to mention 2 additional highlights. First, the MARIPOSA study of RYBREVANT plus lazertinib in frontline non-small cell lung cancer remains on track with the potential for final analysis later in the year.

    展望今年剩餘時間,我們預計來自關鍵管道資產的重要數據,如 Nipocalimab 和 TREMFYA 以及 Talquetamab 的潛在批准。重要的是,我想提兩個額外的亮點。首先,RYBREVANT 加 lazertinib 在一線非小細胞肺癌中的 MARIPOSA 研究仍在進行中,並有可能在今年晚些時候進行最終分析。

  • We are also excited to present data from the SunRISe-1 study of TAR-200 in muscle invasive bladder cancer at the American Urological Association's Annual Meeting this month, which demonstrated a promising complete risks and safety profile.

    我們也很高興在本月的美國泌尿外科協會年會上展示 TAR-200 治療肌肉浸潤性膀胱癌的 SunRISe-1 研究的數據,該研究展示了有希望的完整風險和安全性概況。

  • Regarding our Pharmaceutical business, I'd like to reiterate some comments I recently made at the Cowen Investor Conference in March related to the strengthening of the U.S. dollar and the impact on the 2025 Pharmaceutical sales goal the team put forth during the 2021 Investor Day. While we don't speculate on currency, based on the current rates, the 2025 sales target of $60 billion is approximately $57 billion on a constant currency basis.

    關於我們的製藥業務,我想重申我最近在 3 月份的 Cowen 投資者會議上發表的一些評論,這些評論涉及美元走強以及團隊在 2021 年投資者日提出的 2025 年製藥銷售目標的影響。雖然我們不推測貨幣,但根據當前匯率,2025 年 600 億美元的銷售目標在固定匯率基礎上約為 570 億美元。

  • In 2022 alone, FX had a negative impact of roughly $3 billion in Pharmaceuticals. While that is the math qualitatively since 2021, a number of things have changed in our portfolio. On the plus side, we've seen acceleration of some current and potential upcoming launches like TECVAYLI and Talquetamab. But to be balanced, we've also experienced competitive pressure on IMBRUVICA above what was anticipated in 2021. So many push and pulls, but we are striving to attain our operational goals. We are confident in our ability to exceed 2025 estimates The Street has out there today of approximately $54 billion.

    僅在 2022 年,外匯就對製藥產生了大約 30 億美元的負面影響。雖然這是自 2021 年以來的定性數學,但我們的投資組合中發生了許多變化。從好的方面來說,我們已經看到一些當前和潛在的即將推出的藥物加速上市,如 TECVAYLI 和 Talquetamab。但為了平衡,我們在 IMBRUVICA 上也經歷了超過 2021 年預期的競爭壓力。如此多的推拉,但我們正在努力實現我們的運營目標。我們相信我們有能力超過 2025 年的估計,而華爾街今天估計的價值約為 540 億美元。

  • MedTech delivered a strong quarter of sales growth. We continued to advance key pipeline programs. For example, within our electrophysiology business, we reached a few milestones this quarter related to our pulse field ablation pipeline programs, including the European clinical study Inspire, which achieved early success by meeting both primary safety and efficacy endpoints.

    MedTech 實現了強勁的季度銷售增長。我們繼續推進關鍵管道項目。例如,在我們的電生理學業務中,本季度我們實現了與我們的脈衝場消融管道計劃相關的幾個里程碑,包括歐洲臨床研究 Inspire,該研究通過滿足主要安全性和有效性終點取得了早期成功。

  • Additionally, we announced completion of the first procedures in the European Smartfire clinical study evaluating the safety and effectiveness of our investigational dual energy catheter, which combines both pulse field and Radiofrequency ablation capabilities. As you know, we continue to prioritize investment in high-growth areas, as demonstrated by our acquisition of Abiomed, which closed this past December.

    此外,我們還宣布完成了歐洲 Smartfire 臨床研究的第一個程序,該研究評估了我們研究性雙能量導管的安全性和有效性,該導管結合了脈衝場和射頻消融功能。如您所知,我們繼續優先投資高增長領域,正如我們在去年 12 月完成的對 Abiomed 的收購所證明的那樣。

  • With Abiomed, MedTech now has 12 platforms with over $1 billion annual sales. While it is still early days, we are pleased with the integration and performance of Abiomed. Patient utilization of Abiomed technologies grew mid- to high teens in both Europe and the United States and over 30% in Japan.

    憑藉 Abiomed,MedTech 現在擁有 12 個平台,年銷售額超過 10 億美元。雖然現在還處於早期階段,但我們對 Abiomed 的整合和表現感到滿意。患者對 Abiomed 技術的使用在歐洲和美國都有中高青少年的增長,在日本則超過 30%。

  • We continue to see strong adoption of newer technologies, such as Impella 5.5, and we achieved record quarterly enrollment in both the STEMI DTU and PROTECT 4 pivotal trials as we continue to advance efforts in pursuit of Class I guidelines.

    我們繼續看到新技術的廣泛採用,例如 Impella 5.5,並且隨著我們繼續努力追求 I 類指南,我們在 STEMI DTU 和 PROTECT 4 關鍵試驗中實現了創紀錄的季度註冊。

  • For perspective, operational sales growth compared to the same quarter last year reported by Abiomed as a standalone company was 22%. In Orthopaedics, just this month, we obtained CE Mark for the VELYS Robotic-Assisted Solution, positioning us to expand our international footprint with this differentiated solution in total knee.

    從長遠來看,與 Abiomed 作為獨立公司報告的去年同期相比,營業銷售額增長了 22%。在骨科領域,就在本月,我們的 VELYS 機器人輔助解決方案獲得了 CE 標誌,使我們能夠通過這種差異化的全膝關節解決方案擴大我們的國際足跡。

  • Finally, the MedTech team is excited by the progress being made in regards to the Ottawa general surgery robotic solution, and we remain on track to share more information in the second half of this year.

    最後,MedTech 團隊對渥太華普外科機器人解決方案取得的進展感到興奮,我們將繼續按計劃在今年下半年分享更多信息。

  • Our Consumer Health business delivered double-digit first quarter sales growth driven by strategic price actions, strong demand and some stock replenishment. We remain on track to complete the separation of this business in 2023, assuming accommodative market conditions.

    在戰略性價格行動、強勁需求和一些庫存補充的推動下,我們的消費者健康業務在第一季度實現了兩位數的銷售額增長。假設市場條件寬鬆,我們仍有望在 2023 年完成這項業務的分離。

  • Since the start of the year, we have been operating our Consumer Health business as a company within a company and continue to update our Form S-1 filing with the Securities and Exchange Commission, giving us the opportunity to pursue an initial public offering as a potential first step in the separation. Standup cost and stranded costs remain consistent with what we have stated previously with an active program well underway to reduce the stranded costs.

    自今年年初以來,我們一直以公司內公司的形式經營消費者健康業務,並繼續更新我們向美國證券交易委員會提交的 S-1 表格,使我們有機會進行首次公開募股,作為分離的潛在第一步。站立成本和擱淺成本與我們之前所說的保持一致,並且正在進行一項積極的計劃以減少擱淺成本。

  • Turning to notable enterprise events. I'd like to briefly touch LTL's refiling for bankruptcy on April 4. Neither LTL's original filing nor this refiling is an acknowledgment of wrongdoing nor an indication that the company has changed its long-standing position that its talcum powder products are safe. Our goal continues to be for an equitable and efficient resolution of the cosmetic talc litigation against the company, and we believe this refiling represents progress towards that goal.

    轉向著名的企業事件。我想簡單談談 LTL 在 4 月 4 日重新申請破產。無論是 LTL 的原始申請還是這次重新申請,都不是承認不當行為,也不是表明該公司改變了其滑石粉產品安全的長期立場。我們的目標仍然是公平有效地解決針對該公司的化妝品滑石粉訴訟,我們相信此次重新提交代表了朝著該目標邁進的進展。

  • As a reminder, LTL's bankruptcy filing will not have an impact upon the Kenvue separation, and the talc liabilities in the United States and Canada will remain with Johnson & Johnson. As part of the refiling, we have proposed a reorganization plan that had significant support from claimants and includes a payment of $8.9 billion in present value over a 25-year period. LTL will continue to work through the process set forth by the bankruptcy court and expects to present the reorganization plan to the court in mid-May.

    提醒一下,LTL 的破產申請不會對 Kenvue 的分離產生影響,美國和加拿大的滑石粉債務將由強生公司承擔。作為重新申報的一部分,我們提出了一項重組計劃,該計劃得到了索賠人的大力支持,其中包括在 25 年期間按現值支付 89 億美元。 LTL 將繼續完成破產法庭規定的程序,並預計在 5 月中旬向法庭提交重組計劃。

  • Our capital allocation priorities remain consistent. And in 2022, we successfully executed against all pillars. R&D investment remains our #1 priority and driver of long-term growth and value creation. We know the value our investors place on our dividend, and we were pleased to announce this morning that our Board of Directors has authorized a 5.3% increase, marking our 61st consecutive year of dividend increases.

    我們的資本配置重點保持一致。在 2022 年,我們成功地針對所有支柱執行了。研發投資仍然是我們的第一要務,也是長期增長和價值創造的驅動力。我們知道投資者對我們股息的重視,今天早上我們很高興地宣布,我們的董事會已批准將股息增加 5.3%,這標誌著我們連續第 61 年增加股息。

  • In addition, we continuously evaluate strategic business development opportunities that enable Johnson & Johnson to create value for patients, customers and shareholders. Our final priority is share repurchase programs when appropriate. In fact, this past quarter, we completed the $5 billion share repurchase program announced late last year.

    此外,我們不斷評估戰略業務發展機會,使強生能夠為患者、客戶和股東創造價值。我們的最終優先事項是在適當的時候進行股票回購計劃。事實上,在上個季度,我們完成了去年底宣布的 50 億美元股票回購計劃。

  • We are confident in our strong financial position, including our AAA-rated balance sheet and our ability to deploy capital across all strategic priorities. We believe this strength differentiates Johnson & Johnson and enables us to pull the appropriate levers to set us up for long-term success.

    我們對我們強大的財務狀況充滿信心,包括我們的 AAA 級資產負債表和我們在所有戰略重點上部署資本的能力。我們相信,這種優勢使強生與眾不同,並使我們能夠採取適當的槓桿措施,為我們的長期成功做好準備。

  • Moving on to our full year 2023 guidance for the enterprise. Based on our strong start to the year, we are pleased to raise our guidance. We now expect operational sales growth for the full year 2023 up 1 percentage point in the range of 5.5% to 6.5% or up $1 billion in a range of $97.9 billion to $98.9 billion on a constant currency basis and adjusted operational sales growth up 1 percentage point in the range of 4.5% to 5.5%.

    繼續我們對企業的 2023 年全年指導。基於我們今年的強勁開局,我們很高興提高我們的指導。我們現在預計 2023 年全年的營業銷售額增長 1 個百分點,在 5.5% 至 6.5% 的範圍內,或在 979 億美元至 989 億美元的範圍內增加 10 億美元,按固定匯率計算,調整後的營業銷售額增長 1 個百分點點在 4.5% 至 5.5% 的範圍內。

  • Our sales guidance continues to exclude contribution from the COVID-19 vaccine. As you know, we don't speculate on future currency movements. Last quarter, we noted that we utilized the euro spot rate relative to the U.S. dollar at 1.08. The euro spot rate as of late last week was 1.10. We continue to estimate there would be minimal impact from foreign currency translation on reported sales for the year as the dollar has strengthened versus other select currencies.

    我們的銷售指南繼續排除 COVID-19 疫苗的貢獻。如您所知,我們不推測未來的貨幣走勢。上個季度,我們注意到我們使用的歐元兌美元即期匯率為 1.08。截至上週晚些時候,歐元即期匯率為 1.10。我們繼續估計,由於美元兌其他選定貨幣走強,外幣換算對本年度報告銷售額的影響微乎其微。

  • We are maintaining the guidance we provided in January for our adjusted pretax operating margin, other income and expense, interest expense and tax rate. We are also increasing our adjusted earnings per share guidance by $0.05 per share and tightening the range to $10.50 to $10.60 or $10.55 at the midpoint on a constant currency basis, reflecting operational or constant currency growth of approximately 3.5% to 4.5% or 4% at the midpoint.

    我們維持 1 月份為調整後的稅前營業利潤率、其他收入和支出、利息支出和稅率提供的指引。我們還將調整後的每股收益指引提高了 0.05 美元,並將範圍收緊至 10.50 美元至 10.60 美元或 10.55 美元(按固定匯率計算的中點),反映了運營或固定貨幣增長約 3.5% 至 4.5% 或 4%中點。

  • While not predicting the impact of currency movements, assuming recent exchange rates I previously referenced, our reported adjusted earnings per share for the year would be favorably impacted by approximately $0.05 per share. This favorable currency impact, coupled with our strong operational outlook, results in an increase to our reported adjusted earnings per share for the year by $0.10 per share and tightening the range to $10.60 to $10.70 or $10.65 at the midpoint, reflecting growth of approximately 4.5% to 5.5% or 5% at the midpoint.

    雖然沒有預測貨幣變動的影響,但假設我之前提到的近期匯率,我們報告的年度調整後每股收益將受到約每股 0.05 美元的有利影響。這種有利的貨幣影響,加上我們強勁的運營前景,導致我們今年報告的調整後每股收益增加 0.10 美元,並將範圍收緊至 10.60 美元至 10.70 美元或中點 10.65 美元,反映出約 4.5% 的增長到中點的 5.5% 或 5%。

  • While we do not provide guidance by segment or on a quarterly basis, I'd like to provide some qualitative considerations for your modeling. In Pharmaceuticals, we maintain our expectation of delivering above-market growth in 2023 driven by key assets and continued uptake of our newly launched products. This growth considers the potential composition of matter patent expiry of STELARA, which we currently assume will occur in late 2023 in the United States.

    雖然我們不按細分或按季度提供指導,但我想為您的建模提供一些定性考慮因素。在製藥領域,我們維持我們的預期,即在關鍵資產和我們新推出的產品的持續採用的推動下,在 2023 年實現高於市場的增長。這種增長考慮了 STELARA 的物質專利到期的潛在組成,我們目前假設這將在 2023 年底在美國發生。

  • Further, we continue to expect 2023 impact from other post-LOE products, including REMICADE, ZYTIGA and XEPLION as well as increased austerity measures across Europe. Regarding our COVID-19 vaccine, we do not anticipate material sales beyond that which were recorded in the first quarter as our contractual commitments are complete.

    此外,我們繼續預計 2023 年其他後 LOE 產品的影響,包括 REMICADE 、 ZYTIGA 和 XEPLION 以及整個歐洲增加的緊縮措施。關於我們的 COVID-19 疫苗,由於我們的合同承諾已經完成,我們預計材料銷售額不會超過第一季度記錄的銷售額。

  • In MedTech, we expect continued competitive growth fueled by increased procedures and commercial uptake of recently launched products. We anticipate relatively stable procedure volumes and health care staffing levels for the remainder of the year with normal seasonality.

    在 MedTech 中,我們預計由於程序的增加和最近推出的產品的商業採用,將推動持續的競爭增長。我們預計今年剩餘時間的手術量和醫療保健人員配備水平將相對穩定,季節性正常。

  • Regarding quarterly phasing, given the strength of our first quarter results, we now expect relatively consistent performance throughout the year from our Pharmaceutical and MedTech businesses. When modeling Consumer Health growth rates in 2023, it is important to take into consideration prior year comparisons as well as the robust cough, cold and flu season and the onetime restocking that occurred in the first quarter. As a reminder, the first half of 2022 was impacted by supply constraints.

    關於季度階段,鑑於我們第一季度的強勁業績,我們現在預計我們的製藥和 MedTech 業務在全年的業績將相對穩定。在為 2023 年的消費者健康增長率建模時,重要的是要考慮前一年的比較以及強勁的咳嗽、感冒和流感季節以及第一季度發生的一次性補貨。提醒一下,2022 年上半年受到供應限制的影響。

  • A few brief announcements before we take your questions. Continuing our efforts to increase our transparency and assist with your modeling, we are planning to post a patent table, including U.S. pharmaceutical patents, to our investor website in the quarter.

    在我們回答您的問題之前,先發布一些簡短的公告。我們將繼續努力提高透明度並協助您進行建模,我們計劃在本季度向我們的投資者網站發布專利表,包括美國藥品專利。

  • In addition, please mark your calendars for December 5 as we will be hosting an enterprise business review at the New York Stock Exchange focused on the new Johnson & Johnson, highlighting both our Pharmaceutical and MedTech businesses. We will provide additional details about the event in the coming months.

    此外,請將您的日曆標記為 12 月 5 日,因為我們將在紐約證券交易所舉辦一次企業業務回顧,重點關注新的強生公司,重點介紹我們的製藥和 MedTech 業務。我們將在未來幾個月內提供有關該活動的更多詳細信息。

  • Before we turn to your questions, let me state how proud we are regarding our team's continued hard work and unwavering commitment. Our sights are set on the future, focused on delivering competitive growth for the new Johnson & Johnson. We are confident that our current plans position us for near-term success, long-term growth and value creation for our shareholders.

    在我們回答您的問題之前,讓我先聲明一下,我們對我們團隊的持續努力和堅定不移的承諾感到非常自豪。我們著眼於未來,專注於為新的強生公司帶來有競爭力的增長。我們相信,我們目前的計劃將使我們能夠在短期內取得成功、實現長期增長並為股東創造價值。

  • I'll now turn the discussion to the Q&A portion of the call. Kevin, can you please provide instructions for those wishing to ask a question?

    我現在將討論轉到電話的問答部分。凱文,你能為那些想問問題的人提供指導嗎?

  • Operator

    Operator

  • (Operator Instructions) Our first question is coming from Chris Schott from JPMorgan.

    (操作員說明)我們的第一個問題來自摩根大通的 Chris Schott。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Just maybe a 2-parter on the pharma side. First, on the $57 billion target for pharma, I think your comments are very clear in terms of your confidence of exceeding consensus of $54 billion. Are you still confident though in that $57 billion target as we think about kind of the pushes and pulls that you just outlined there?

    也許只是製藥方面的一個 2 夥伴。首先,關於製藥業 570 億美元的目標,我認為你的評論非常明確,你有信心超過 540 億美元的共識。當我們考慮您剛才概述的那種推動和拉動時,您仍然對 570 億美元的目標充滿信心嗎?

  • And then maybe just a specific question on RYBREVANT. Just want to make sure the comments correctly there. I think you mentioned there's a final analysis of MARIPOSA later this year. Does that mean the interim has passed at this point? And maybe just put some context of what you think you need to show in that study to dislodge share from TAGRISSO.

    然後可能只是一個關於 RYBREVANT 的具體問題。只是想確保那裡的評論正確。我想你提到了今年晚些時候對 MARIPOSA 的最終分析。這是否意味著此時過渡期已經過去?也許只是把你認為你需要在該研究中展示的一些內容放在一起,以取代 TAGRISSO 的份額。

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Thanks, Chris. I appreciate the questions. So first, with respect the $57 billion, I wanted to make sure that I was clear on the record since I had the opportunity to do that about a month ago that everybody understood the message around the math component of it.

    謝謝,克里斯。我很欣賞這些問題。所以首先,關於 570 億美元,我想確保我在記錄中清楚,因為我有機會在大約一個月前這樣做,每個人都理解圍繞它的數學部分的信息。

  • We feel very good about our pipeline. We continue to work towards some really good data that came out this quarter around multiple myeloma, MARIPOSA, which we'll talk about in a minute. We continue to see some uptake of some of our newer products. And the goal is still that for us. But you'll have a much better and much more informed and probably timely update once we hit the December 5 meeting at the New York Stock Exchange. So stay posted on that.

    我們對我們的管道感覺很好。我們繼續努力爭取本季度圍繞多發性骨髓瘤 MARIPOSA 出現的一些非常好的數據,我們將在一分鐘內討論這些數據。我們繼續看到一些新產品的使用。目標仍然是我們的目標。但是,一旦我們於 12 月 5 日在紐約證券交易所召開會議,您將獲得更好、更知情、可能更及時的更新。所以請繼續關注。

  • What I do feel comfortable though is that we're moving certainly in the right direction. I wanted to take out the unclarity that maybe was created by currency and the dramatic movements that occurred over the last 18 months.

    不過,讓我感到舒服的是,我們確實在朝著正確的方向前進。我想消除可能由貨幣和過去 18 個月發生的戲劇性變動造成的不確定性。

  • So for MARIPOSA, I would say the study of RYBREVANT, lazertinib in frontline non-small cell lung cancer versus TAGRISSO remains very much on track. It's an event-driven trial. So there's the potential for final analysis later this year, which is actually 2 quarters ahead than what we had originally expected, was originally expected to be second quarter of 2024.

    因此,對於 MARIPOSA,我想說 RYBREVANT、lazertinib 在一線非小細胞肺癌中與 TAGRISSO 的研究仍然非常順利。這是一個事件驅動的試驗。所以有可能在今年晚些時候進行最終分析,實際上比我們原先預期的要提前兩個季度,原先預計是 2024 年第二季度。

  • The accrual to the study we can say is very rapid as there was tremendous interest. And the interim analysis was specified in the protocol with a significantly limited follow-up and supported the continuation of the study.

    我們可以說這項研究的增長非常迅速,因為人們對此非常感興趣。並且中期分析在協議中指定,隨訪非常有限,並支持研究的繼續進行。

  • We were blinded to that interim analysis. And as far as what we need to show, I think we're just going to let the science dictate, let the trial results come out. But we feel pretty comfortable where we're at now and pleased with how quickly the trial enrolled.

    我們對中期分析視而不見。就我們需要展示的內容而言,我認為我們只是讓科學來決定,讓試驗結果出來。但我們對我們現在的處境感到非常滿意,並且對試驗的註冊速度如此之快感到滿意。

  • Operator

    Operator

  • Next question is coming from Matt Miksic from Barclays.

    下一個問題來自巴克萊銀行的 Matt Miksic。

  • Matthew Stephan Miksic - Research Analyst

    Matthew Stephan Miksic - Research Analyst

  • I have, if I could, just one question on knees and a quick follow-up, kind of a general strategy question on STELARA pharma if I could. So on knees in the U.S., obviously, very strong growth. And just wondering if you could -- and I think expectations have been strong throughout Q1.

    如果可以的話,我只有一個問題和快速跟進,如果可以的話,這是一個關於 STELARA 製藥公司的一般戰略問題。所以在美國屈膝,顯然,非常強勁的增長。只是想知道你是否可以——我認為整個第一季度的期望都很高。

  • I just was wondering if you could maybe give a little bit of color as to what's driving that strength? How much of that is maybe the robot? How much of that is on other product launches? And then one quick follow-up on pharma if I may.

    我只是想知道你是否可以給出一些關於驅動這種力量的顏色?其中有多少可能是機器人?其中有多少用於其他產品發布?如果可以的話,然後對製藥公司進行快速跟進。

  • Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

    Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

  • Matt, thank you for the question. And before I turn it to Joe and STELARA, it's really nice to see 12% growth in the U.S. for knees. We haven't seen that in a while. But before I get into specifically knees, maybe just a quick frame on like the quarter.

    馬特,謝謝你的提問。在我轉向 Joe 和 STELARA 之前,很高興看到美國的膝蓋增長了 12%。我們有一段時間沒看到了。但在我特別跪下之前,也許只是像四分之一的快速框架。

  • Obviously, first, the industry I think continues to remain strong and growing. Procedures are well in recovery mode. It's awesome to see an 11% operational performance and 6.4 adjusted ops for the first quarter.

    顯然,首先,我認為該行業繼續保持強勁和增長。程序處於恢復模式。看到第一季度 11% 的運營績效和 6.4 調整後的運營,真是太棒了。

  • It was our first quarter with Abiomed. So if you look at them on like-for-like periods, it's a standalone of 22% growth. But I think when I look at all of the math, if you will, for the quarter, what I'm most pleased about is really the balanced growth.

    這是我們與 Abiomed 的第一個季度。因此,如果你在類似時期看它們,它是獨立的 22% 的增長。但我認為,當我查看所有數學時,如果你願意的話,對於本季度,我最高興的是真正的平衡增長。

  • And we had our BWI business up 13%. Our global vision, up 8%. And our U.S. business, the largest market, growing north of 8% really fueled by ortho performance, up 6% as well as surgery up 6. And you hear us talk about this 12 $1 billion platform, but 6 of those grew double digit in the United States in the quarter.

    我們的 BWI 業務增長了 13%。我們的全球視野,增長了 8%。我們的美國業務是最大的市場,在矯形性能的推動下增長了 8% 以上,增長了 6%,手術增長了 6%。你聽到我們談論這個 12 億美元的平台,但其中 6 個增長了兩位數美國在本季度。

  • EMEA was strong, and Asia was a little bit softer going by China. Obviously, Jan and Feb was a bit softer. We were encouraged with March procedures recovered in March. But I would call it 3 specific innovations, and then I'll go deeper into knees.

    歐洲、中東和非洲地區表現強勁,而亞洲在中國的表現略微疲軟。顯然,1 月和 2 月要軟一些。我們對 3 月份恢復的 3 月份程序感到鼓舞。但我會稱之為 3 項具體創新,然後我會更深入地討論。

  • One is our pulse field ablation. So we're very pleased with the data that an AFib that it's promising. We have 4 clinical trials ongoing. 2 out of the 4, we've completed enrollment, and we shared the data from the INSPIRE trial where we met the primary endpoint for both safety and efficacy.

    一個是我們的脈衝場消融。因此,我們對 AFib 有希望的數據感到非常滿意。我們正在進行 4 項臨床試驗。 4 人中有 2 人已經完成註冊,我們分享了 INSPIRE 試驗的數據,我們在該試驗中達到了安全性和有效性的主要終點。

  • Our Abiomed, as we've talked about, we're about 90 days in. They continue to advance the innovation pipeline. They're in clinic in 4 clinical trials to expand new products and to expand indications to get on designation.

    正如我們所談到的,我們的 Abiomed 已經進行了大約 90 天。他們繼續推進創新管道。他們正在進行 4 項臨床試驗,以擴展新產品並擴大適應症以獲得指定。

  • And last, I would say, Matt, we are in all things robotics. So let's talk about VELYS. We just received CE Mark positioning it for expansion to more global markets. Right now, we're in 5. But I'm pleased to say that it's now the fastest-growing knee robotic system in the United States.

    最後,我想說,馬特,我們涉及機器人技術。那麼讓我們談談VELYS。我們剛剛收到 CE 標誌,將其定位為擴展到更多的全球市場。現在,我們在 5。但我很高興地說,它現在是美國增長最快的膝關節機器人系統。

  • We've completed over 20,000 procedures. And we're taking a systems approach to our business in hips to shoulders and the spine. Our Monarch platform is the first and only multispecialty flexible robotics solution with FDA clearance in bronchoscopy as well as endo-urology.

    我們已經完成了 20,000 多個程序。我們正在對我們從臀部到肩膀和脊柱的業務採取系統方法。我們的 Monarch 平台是第一個也是唯一一個在支氣管鏡檢查和泌尿外科領域獲得 FDA 批准的多專業柔性機器人解決方案。

  • We've completed 25,000 procedures and are in clinic right now combining the Monarch and [Alumina] navigation with ablation treatment technology on NeuWave. And just recently, in February, we were -- the first patient received robotic-assisted removal of kidney stone. We're trying to get a higher kidney stone clearance rate than the standard of care.

    我們已經完成了 25,000 個程序,目前正在臨床上將 Monarch 和 [Alumina] 導航與 NeuWave 上的消融治療技術相結合。就在最近,在二月份,我們是——第一位接受機器人輔助移除腎結石的患者。我們正在努力獲得比護理標準更高的腎結石清除率。

  • And last, as we talked about our team in Ottawa is really progressing significantly, really looking forward to a back half of the year update with the team. So VELYS is really a combination of having access to cementless, both on fixed bearing and rotating platform, revision, our new introduction of the stabilized knees and most importantly, not just coupled with the robotic system of VELYS, but coupled with the most modern knee implant in the world.

    最後,當我們談到我們在渥太華的團隊時,確實取得了顯著進步,真的很期待與團隊一起進行今年後半年的更新。所以 VELYS 真的是結合了無骨水泥,固定軸承和旋轉平台,翻修,我們新推出的穩定膝蓋,最重要的是,不僅與 VELYS 的機器人系統相結合,而且與最現代的膝蓋相結合植入世界。

  • Matthew Stephan Miksic - Research Analyst

    Matthew Stephan Miksic - Research Analyst

  • Well, that was a fantastic overview. Congrats on innovation and the significant change in momentum across all those businesses. Just a quick question, I guess, I had on pharma was -- I mean, it's a big question, and I think it's on a lot of investors' minds is if we turn into the end of the year and you think about STELARA, and you think about sort of the actions that you expect to take whether organic, the pipeline that you have and as it comes through, and some of these new products launch and get bigger. And then strategic, if you could maybe give a sense of what are your goals over the next 12, 18 months as you sort of weather that LOE, and what sort of mix of action should we expect you to take to kind of manage through that?

    嗯,這是一個很棒的概述。祝賀所有這些企業的創新和勢頭的重大變化。只是一個簡短的問題,我想,我對製藥業的看法是——我的意思是,這是一個大問題,我認為很多投資者都在想,如果我們到了年底,你會考慮 STELARA,你會考慮你希望採取的行動,無論是有機的,你擁有的管道和它通過的管道,以及這些新產品中的一些推出並變得更大。然後是戰略性的,如果你能在接下來的 12 個月、18 個月內了解你的目標是什麼,因為你有點天氣那 LOE,以及我們應該期望你採取什麼樣的行動組合來管理它?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Sure. Thanks, Matt, for the question. A lot to maybe unpack possibly there. But let me first start with our base assumption, the guidance, which has the underlying assumption that in the U.S., STELARA will lose exclusivity in the late third quarter, early fourth quarter of this year. And that's kind of the assumption that we're going on.

    當然。謝謝馬特提出這個問題。可能在那裡打開很多東西。但讓我首先從我們的基本假設開始,即指導,其基本假設是在美國, STELARA 將在今年第三季度末、第四季度初失去獨家經營權。這就是我們正在進行的假設。

  • What I would say is that's somewhat fluid. At this point, there are currently no biosimilars approved. In terms of our planning, we are expecting -- despite learning a lot over the last few years with REMICADE, we're expecting a steeper erosion curve than what was experienced there because this is a self-administered subcutaneous product.

    我要說的是,這有點不穩定。在這一點上,目前還沒有批准的生物仿製藥。就我們的計劃而言,我們預計——儘管在過去幾年中從 REMICADE 中學到了很多東西,但我們預計侵蝕曲線會比那裡經歷的更陡峭,因為這是一種自我管理的皮下產品。

  • There will be multiple competitors on the market at some point, and they may have the affordability of interchangeability. But we may remain committed to growing through the patent exploration. One of the great things about our portfolio, whether we're talking within Pharmaceuticals or across the broader businesses, we've got 30 products or platforms that generate over $1 billion in annual revenue. So we're not dependent on one product the way others may have.

    某個時候市場上會有多個競爭者,他們可能具有互換性的承受能力。但我們可能會繼續致力於通過專利探索實現增長。無論是在製藥行業還是在更廣泛的業務範圍內,我們的產品組合的一大優點是,我們擁有 30 種產品或平台,年收入超過 10 億美元。所以我們不像其他人那樣依賴一種產品。

  • In terms of unpacking your question maybe a little bit further, I got the sense you were heading towards M&A. Certainly, we always remain vigilant and look at a number of opportunities, making sure there's a strategic fit before we act. If there's strategic fit, then we're going to look to deploy capital in the way that returns to shareholders to compensate them, quite frankly, for the risk that we're bearing on their behalf.

    就進一步解開你的問題而言,我覺得你正在走向併購。當然,我們始終保持警惕並尋找許多機會,確保在我們採取行動之前有一個戰略契合點。如果有戰略契合,那麼我們將尋求以回報股東的方式部署資本,以補償他們,坦率地說,我們代表他們承擔的風險。

  • But we're not going to do anything out of desperation based on the breadth of our product portfolio. We are lucky in that we've got a strong balance sheet to do whatever we'd like, but we want to make sure it makes good strategic and financial sense. So that's probably the best way to answer that.

    但基於我們產品組合的廣度,我們不會出於絕望而做任何事情。我們很幸運,因為我們擁有強大的資產負債表,可以做任何我們想做的事,但我們希望確保它具有良好的戰略和財務意義。所以這可能是回答這個問題的最佳方式。

  • I know Jennifer and the team are very committed to growing through STELARA whenever that may occur. And the pipeline data that we're generating now as well as really the early success we're having in some of these newer products, I think, positions us well to meet those goals.

    我知道 Jennifer 和團隊非常致力於在可能發生的情況下通過 STELARA 發展。我認為,我們現在正在生成的管道數據以及我們在其中一些新產品中取得的早期成功,使我們能夠很好地實現這些目標。

  • Operator

    Operator

  • Your next question today is coming from Terence Flynn from Morgan Stanley.

    您今天的下一個問題來自摩根士丹利的 Terence Flynn。

  • Terence C. Flynn - Equity Analyst

    Terence C. Flynn - Equity Analyst

  • Great. Maybe a 2-part one for me as well. Thanks for the update on the talc litigation, Joe. I was just wondering if you could comment at all about additional progress towards that 75% threshold, specifically the denominator and kind of where that's shaking out?

    偉大的。也許對我來說也是一個兩部分的。感謝您更新滑石粉訴訟,喬。我只是想知道您是否可以對朝著 75% 的門檻取得的額外進展發表評論,特別是分母以及正在發生變化的地方?

  • And then on the oral IL-23 program there, just wondering if you can confirm if you're going to advance into Phase III and where that drug might be positioned ultimately in the treatment paradigm based on the data you guys have seen thus far?

    然後關於那裡的口服 IL-23 計劃,只是想知道你是否可以確認你是否要進入 III 期,以及根據你們迄今為止看到的數據,該藥物最終可能定位在治療範例中的什麼位置?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Great. Thanks for the question, Terence. Let me start with the second one first with respect to the oral IL-23, where our partners at Protagonist announced some very encouraging data out of the Phase II Frontier 1 study. So we do plan to present data from various preclinical and clinical studies on this compound at medical conferences beginning in the second quarter of this year.

    偉大的。謝謝你的問題,特倫斯。讓我從第二個開始,首先是關於口服 IL-23,我們在 Protagonist 的合作夥伴宣布了 II 期 Frontier 1 研究中的一些非常令人鼓舞的數據。因此,我們確實計劃在今年第二季度開始的醫學會議上展示該化合物的各種臨床前和臨床研究數據。

  • We believe this could be very much a important and underappreciated asset within our immunology portfolio. With respect to the litigation, we thought that this could come up as a question. So we're very pleased to have Andrew White, our Assistant General Counsel, here with us today.

    我們相信這可能是我們免疫學產品組合中非常重要且未被充分認識的資產。關於訴訟,我們認為這可以作為一個問題提出來。因此,我們很高興今天有我們的助理總法律顧問安德魯·懷特 (Andrew White) 和我們在一起。

  • But let me say a little maybe a couple of qualitative things from my seat, and then we can have Andrew either clean it up or give you some more specifics. But it is important to note that these cases and we stand by the safety of the product, there's decades of independent research conducted by reputable government agencies, patient advocacy groups as well as academic institutions that support the safety of cosmetic talc.

    但是讓我在座位上說一些定性的事情,然後我們可以讓安德魯清理它或給你一些更具體的信息。但重要的是要注意這些案例,我們支持產品的安全性,知名政府機構、患者權益團體以及支持化妝品滑石粉安全性的學術機構進行了數十年的獨立研究。

  • Furthermore, it was only 2 years ago at Dahlberg hearing where the judge really restricted the use of many of the claims, supposedly scientific claims that were being made by the plaintiffs attorneys in this case and many pundits even classified it as junk science at that point. Here, we have the support of 60,000 to 70,000 claimants that would vote for the proposal as it's currently presented.

    此外,僅在 2 年前的達爾伯格聽證會上,法官才真正限制使用許多主張,據稱是原告律師在本案中提出的科學主張,當時許多專家甚至將其歸類為垃圾科學.在這裡,我們得到了 60,000 到 70,000 名索賠人的支持,他們將投票支持目前提出的提案。

  • But curiously, we've got a small number of plaintiff's attorneys who don't even want to give their claimants the right to vote. So we're simply asking that they get the right to vote.

    但奇怪的是,我們有一小部分原告律師甚至不想給原告投票權。所以我們只是要求他們獲得投票權。

  • Now from my chair as CFO, it is unfortunate that we've got to put dollars towards, quite frankly, baseless scientific claims. However, litigation is inherently costly when it's protracted. And it's also inherently uncertain. And our proposal really aims to bring certainty in a very efficient manner for all really involved, something that would otherwise take probably decades to resolve. So let me turn it over to Andrew in terms of maybe any of the specifics that you can add.

    現在,從我擔任首席財務官的角度來看,很不幸,我們必須坦率地說,把錢花在毫無根據的科學主張上。然而,訴訟一旦拖延,成本自然會很高。而且它本身也具有不確定性。我們的提議真正旨在以一種非常有效的方式為所有真正參與的人帶來確定性,否則這可能需要數十年才能解決。因此,讓我根據您可以添加的任何細節將其轉交給安德魯。

  • Andrew White

    Andrew White

  • Thanks, Joe. As Joe mentioned, we are very confident in the position that we stand today in terms of support for the plan. We have well over 60,000 that have expressed a desire to vote for this plan. And the expectation is that we will move forward with a reorganization plan to present to the court within the next 30 days and hope to quickly move to a vote.

    謝謝,喬。正如 Joe 所提到的,我們對我們今天在支持該計劃方面所處的立場非常有信心。我們有超過 60,000 人表示希望投票支持該計劃。預計我們將在未來 30 天內向法院提交重組計劃,並希望盡快進行表決。

  • And we believe once we put that plan out for a vote, we'll gain even more support from a small, but I would say, vocal minority of attorneys. So we believe we're going to reach that 75% threshold and look forward to getting that plan out to a vote.

    我們相信,一旦我們將該計劃付諸表決,我們將獲得少數但我要說的少數律師的更多支持。因此,我們相信我們將達到 75% 的門檻,並期待將該計劃付諸表決。

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Thank you, Andrew.

    謝謝你,安德魯。

  • Operator

    Operator

  • Next question today is coming from Larry Biegelsen from Wells Fargo.

    今天的下一個問題來自 Wells Fargo 的 Larry Biegelsen。

  • Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst

    Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst

  • Joe, 2 for you on the guidance. I heard you on CNBC this morning, and you said you turned from cautious in January to optimistic now about 2023. So I was curious about 2 things. One, on the guidance you previously expected second half to be better than the first half in MedTech and pharma because of the growth drivers you -- on the Q4 call. So what changed there? Why do you expect growth to be more stable through the year?

    Joe, 2 為您指導。我今天早上在 CNBC 上聽到你說你從 1 月份的謹慎轉變為現在對 2023 年的樂觀。所以我對兩件事感到好奇。第一,在第四季度的電話會議上,由於您的增長動力,您之前預計下半年在 MedTech 和製藥行業的表現會好於上半年。那麼那裡發生了什麼變化?為什麼您預計今年的增長會更加穩定?

  • And second, Joe, on the margins. Q1 was up about 60 basis points year-over-year in Q1 on the operating margin but you expect -- and you expect gross margins to improve through 2023 as inflation wanes. So why would the operating margin be flat for the full year?

    第二,喬,在邊緣。第一季度營業利潤率同比增長約 60 個基點,但您預計 - 隨著通貨膨脹減弱,您預計到 2023 年毛利率將有所改善。那麼,為什麼全年的營業利潤率會持平呢?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Yes. Thanks, Larry. Well, first, I do want to correct the record a little bit on you. Responsibly was in front of both cautious as well as optimistic. So we've moved from responsibly cautious to responsibly optimistic.

    是的。謝謝,拉里。好吧,首先,我確實想糾正一下你的記錄。 Responsibly 既謹慎又樂觀。因此,我們已經從負責任的謹慎轉變為負責任的樂觀。

  • Why do I say that? It's because we did see some dynamics within our P&L, the team's great ability to really manage our resources effectively with the backdrop of really a company separation that could lend itself to some stranded costs. We're managing those extremely well.

    我為什麼這麼說?這是因為我們確實在我們的損益表中看到了一些動態,團隊在真正的公司分離的背景下真正有效地管理我們的資源的強大能力可能會導致一些擱淺的成本。我們對這些管理得非常好。

  • There is still inflation within the P&L. I don't think we should say that it's now behind us. We have a good data point with respect to where we landed Q1. I'm very pleased with the first quarter results and the strength of that and why we've maybe moved from a little bit more of a consistent approach throughout the year versus a stronger second half from the first half is really around the first quarter results.

    損益表中仍然存在通貨膨脹。我認為我們不應該說它現在已經過去了。關於我們在第一季度登陸的地方,我們有一個很好的數據點。我對第一季度的結果及其優勢感到非常滿意,以及為什麼我們可能在全年從更一致的方法轉向下半年從上半年開始變得更強勁的原因實際上是圍繞第一季度的結果.

  • So in terms of Pharmaceutical pricing, it was still unfavorable as you might expect with respect to Pharmaceutical, but not as unfavorable as we anticipated. And then maybe we can talk here, too. When we came out in January, there was -- the pandemic was kind of full-blown in the Asia Pacific region. And we did see a very positive data point in March with respect to China specifically. I don't know, Ashley, anything to add there?

    因此,就藥品定價而言,它仍然像您對藥品的預期那樣不利,但並不像我們預期的那樣不利。然後也許我們也可以在這裡談談。當我們在 1 月份出來時,亞太地區的大流行病已經全面爆發。我們確實在 3 月份看到了一個非常積極的數據點,特別是與中國有關的數據點。我不知道,Ashley,有什麼要補充的嗎?

  • Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

    Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

  • Yes. No, Larry, what I would share is I would say that procedures are trending well above all pre-COVID levels. It was up until December with the exception of China. China in December, January and February were well below pre-COVID levels. In January trending neck down 50%.

    是的。不,拉里,我要分享的是,程序的趨勢遠高於 COVID 之前的所有水平。除中國外,一直持續到 12 月。中國在 12 月、1 月和 2 月的數據遠低於 COVID 前的水平。 1 月份趨勢頸部下降了 50%。

  • So I am encouraged to see in March that they're back up. They're back up a little bit ahead of pre-COVID levels. And so that's why we're kind of rebalancing the year. I think that we're going to have more stability throughout the balance to go year versus earlier thinking that we would be having a stronger second half versus first half.

    所以我很高興看到他們在三月份恢復了。他們比 COVID 之前的水平有所回升。這就是為什麼我們要重新平衡這一年。我認為,與之前認為下半年比上半年更強勁的想法相比,我們將在今年的平衡中更加穩定。

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Yes. And Larry, with respect to operating margins, it's still very early in the year. It's still only April. If we have the opportunity to manage these macroeconomic headwinds that we ended the year with and then maybe provide the flexibility for further investment for great opportunities down the road that fortify the future, we'll certainly look to do that.

    是的。拉里,就營業利潤率而言,今年還很早。現在還只是四月。如果我們有機會管理我們在年底遇到的這些宏觀經濟逆風,然後可能會為進一步投資提供靈活性,以獲得鞏固未來的巨大機會,我們當然會這樣做。

  • You guys know us well enough that if we don't find those meaningful opportunities, we'll probably have the opportunity to take up guidance down the road. But my first preference would be to deploy that in investment opportunities that secure both MedTech and Pharmaceuticals for the future.

    你們非常了解我們,如果我們找不到那些有意義的機會,我們可能會有機會在未來接受指導。但我的首選是將其部署在能夠確保未來醫療技術和製藥業的投資機會中。

  • Operator

    Operator

  • Next question today is coming from Louise Chen from Cantor Fitzgerald.

    今天的下一個問題來自 Cantor Fitzgerald 的 Louise Chen。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So I had a Pharmaceutical question for you. You've built a really strong oncology franchise. And what are some unique approaches you think you can take to create combos and regimens that might not be available to other companies? And are there any additional areas in oncology that you would like to be involved in that you are not now currently involved in?

    所以我有一個藥學問題要問你。你已經建立了一個非常強大的腫瘤專營權。您認為可以採用哪些獨特的方法來創建其他公司可能無法使用的組合和方案?在腫瘤學中,是否有您希望參與但目前尚未參與的其他領域?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Yes. Thanks for the question, Louise. So I think we're always looking at combinations. The one that's most prolific at this point now is certainly the one for non-small cell lung cancer, which really impacts about 20% of -- until it's diagnosed today with a certain mutation.

    是的。謝謝你的問題,路易絲。所以我認為我們一直在尋找組合。目前最多產的肯定是非小細胞肺癌,它真正影響了大約 20%——直到今天被診斷出具有某種突變。

  • We're very much looking forward to the data that may read out later this year with respect to that. In terms of new areas, I know that the teams are looking very much. I would say some of the new areas that we're coming into now would be some of the bispecific antibodies with respect to multiple myeloma rounding out that portfolio.

    我們非常期待今年晚些時候可能會讀出的相關數據。在新領域方面,我知道團隊非常期待。我想說的是,我們現在進入的一些新領域將是一些與多發性骨髓瘤相關的雙特異性抗體,以完善該產品組合。

  • We know how I want to say almost personalized that disease is and having multiple options for treatments and maybe even someday potentially cures certainly lends itself with the multiple options that we have. We're going to be focused on multiple myeloma, obviously, prostate cancer, lung cancer. We're very excited about some of the data that could read out on what I'll call the MedTech pharma combo of -- for bladder cancer and with the TARIS device with the drug eluting Balversa. So there's multiple plays within oncology, which is now our biggest franchise with immunology in terms of sales contribution to the pharmaceutical success.

    我們知道我想說的幾乎是個性化的疾病,並且有多種治療選擇,甚至有朝一日可能治愈,這肯定會為我們提供多種選擇。我們將專注於多發性骨髓瘤,顯然是前列腺癌、肺癌。我們對一些數據感到非常興奮,這些數據可以讀出我稱之為 MedTech 製藥組合的數據——用於膀胱癌和帶有藥物洗脫 Balversa 的 TARIS 裝置。因此,腫瘤學領域有多種玩法,就銷售對製藥成功的貢獻而言,這是我們目前最大的免疫學專營權。

  • Jessica Moore - VP of IR

    Jessica Moore - VP of IR

  • The only aspect that I'd add, Louise, is as you know, our multiple myeloma platform is extremely strong. And we're looking at some multiple clinical trials about not cannibalizing those products, but rather looking at combination treatments as well as sequences of those products between TECVAYLI, DARZALEX, CARVYKTI and then hopefully our soon to be approved talquetamab.

    Louise,我唯一要補充的是,正如你所知,我們的多發性骨髓瘤平台非常強大。我們正在研究一些關於不蠶食這些產品的多項臨床試驗,而是研究 TECVAYLI、DARZARLEX、CARVYKTI 之間的聯合治療以及這些產品的序列,然後希望我們即將獲得批准的 talquetamab。

  • Operator

    Operator

  • Next question is coming from Josh Jennings from TD Cowen.

    下一個問題來自 TD Cowen 的 Josh Jennings。

  • Joshua Thomas Jennings - MD & Senior Research Analyst

    Joshua Thomas Jennings - MD & Senior Research Analyst

  • Had a question for Ashley just on the FARAPULSE PFA platform. I was hoping that just get an update on commercial time lines. Anything you can share just in terms of CE Mark and then FDA approvals.

    剛剛在 FARAPULSE PFA 平台上向 Ashley 提問。我希望只是獲得有關商業時間表的更新。您可以僅根據 CE 標誌和 FDA 批准分享任何內容。

  • And then maybe digging a little bit deeper, just helping us understand. I mean, our expectation is that FARAPULSE will be third to market in the United States, but what percentage of Biosense revenues are levered to the ablation catheter segment within the EP industry? And what drives your optimism that FARAPULSE will maintain -- be able to maintain license leadership position in the ablation catheter segment?

    然後可能會挖掘得更深一點,只是幫助我們理解。我的意思是,我們的預期是 FARAPULSE 將在美國市場上排名第三,但是 Biosense 收入中有多少百分比用於 EP 行業的消融導管部分?是什麼讓您對 FARAPULSE 將保持樂觀——能夠在消融導管領域保持許可領導地位?

  • Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

    Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

  • Thank you, Josh. Listen, it's a really important space. And we always say at J&J, we're always trying to intercept disease before it advances. And this is one example of managing atrial fibrillation, which is the leading cause of cardiac arrhythmia and unmanaged, that could lead to a stroke.

    謝謝你,喬希。聽著,這是一個非常重要的空間。我們總是在 J&J 說,我們總是試圖在疾病發展之前攔截它。這是控制心房顫動的一個例子,心房顫動是心律失常的主要原因,如果不加以控制,可能會導致中風。

  • So what gives us confidence that we can lead and compete and have a source of differentiation, I would say kind of the following. I'd say, one, we have a 20-year track record of being a world leader in cardiac ablation. We have 5,000-plus installed base.

    那麼是什麼讓我們有信心我們可以領先和競爭並擁有差異化的來源,我想說的是以下幾種。我想說,第一,我們在心臟消融領域擁有 20 年的世界領先地位。我們擁有 5,000 多個安裝基礎。

  • We do see the promise of PFA. We are actively engaged in 4 clinical trials. 2 of those trials have completed enrollment, the European and the Inspire as well as the U.S. We've shared data in February in the international AFib symposium that we met the primary endpoint.

    我們確實看到心理急救的承諾。我們正積極參與 4 項臨床試驗。其中 2 個試驗已經完成註冊,歐洲和 Inspire 以及美國。我們在 2 月份的國際 AFib 研討會上分享了我們達到主要終點的數據。

  • And I would tell you, our approach is really what's differentiated, Josh. So we're kind of leveraging a deep expertise and the insights into the various ablation strategies. So we have a portfolio of PFA catheters, which are fully integrated into their CARTO 3 system and it's powered kind of our true pulse generator.

    我會告訴你,我們的方法確實與眾不同,Josh。因此,我們在某種程度上利用了深厚的專業知識和對各種消融策略的洞察力。因此,我們擁有一系列 PFA 導管,它們完全集成到他們的 CARTO 3 系統中,並且由我們真正的脈衝發生器提供動力。

  • So we really underscore the importance of how important mapping is and vision to know where operators are and what they're doing in the heart anatomy. And kind of the bottom line for us is we actually think access to radio frequency, which has like 20-plus years of safety and efficacy coupled with the newer generation of PFA is really going to be the winning combo for electrophysiologists.

    因此,我們真正強調了映射的重要性以及了解操作員所在位置以及他們在心臟解剖學中正在做什麼的願景的重要性。對我們來說,底線是我們實際上認為獲得射頻,它具有 20 多年的安全性和有效性,再加上新一代 PFA,真的將成為電生理學家的成功組合。

  • It's really why we are in clinic right now with the dual energy solution because we think it could offer the relative safety of the PFA and really the proven durability of radio frequency. So we're not issuing specific timelines, but you can know that we've completed enrollment in 2 of those 4 clinical trials.

    這就是我們現在在臨床上使用雙能量解決方案的真正原因,因為我們認為它可以提供 PFA 的相對安全性和真正經驗證的射頻耐用性。所以我們沒有發布具體的時間表,但你可以知道我們已經完成了這 4 項臨床試驗中的 2 項的註冊。

  • Operator

    Operator

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

    您的下一個問題來自美國銀行的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • I have 2 related ones in pharma. So on IMBRUVICA, how do you guys view the impact from the indication withdrawal? And is there a risk of other non-CLL indications like follicular being pulled? And then related to your hematology business, do you guys have a status update on CARVYKTI supply after or was this quarter a really good quarter?

    我在製藥業有 2 個相關的。那麼在 IMBRUVICA 上,你們如何看待退出適應症的影響?是否存在其他非 CLL 適應症的風險,如毛囊被拉扯?然後與您的血液學業務相關,你們是否有關於 CARVYKTI 供應的狀態更新,或者本季度是一個非常好的季度?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Yes. Thanks for the question, Jeff. So with respect to IMBRUVICA, I would say that we're not expecting any more withdrawals at this point. It is obviously based on our performance encountering competitive pressures. But it's really the competition that's been the biggest driver in terms of the performance that we're not seeing there, quite frankly. But it's -- the withdrawal was a very small part of our business to begin with, but we don't anticipate other withdrawals at this point.

    是的。謝謝你的問題,傑夫。因此,關於 IMBRUVICA,我想說我們目前預計不會再有任何提款。這顯然是基於我們遇到競爭壓力的表現。但坦率地說,就我們在那裡沒有看到的表現而言,真正的競爭才是最大的驅動力。但它 - 撤回一開始只是我們業務的一小部分,但我們目前預計不會有其他撤回。

  • With respect to your second question and supply on CARVYKTI, I would say that you probably did read the announcement recently that we did sign on for additional capacity to scale up some production and increase availability moving forward. The manufacturing is ramping up to supply markets.

    關於您關於 CARVYKTI 的第二個問題和供應,我想說您最近可能確實閱讀了我們確實簽署了額外產能以擴大一些生產並增加可用性的公告。製造業正在加速供應市場。

  • We have really tremendous demand given some of the data that supports this -- the CARVYKTI, the CAR-T for Johnson & Johnson. And we're committed to doing everything we can to accelerate our manufacturing abilities to meet that demand. We work in our facility and again continues to progress. And it will serve as an important part of our supply chain network for not just this but other cell therapies in the future.

    鑑於一些支持這一點的數據——CARVYKTI,強生公司的 CAR-T,我們確實有巨大的需求。我們致力於盡我們所能來加快我們的製造能力以滿足這一需求。我們在我們的設施中工作,並再次繼續進步。它將成為我們供應鍊網絡的重要組成部分,不僅適用於此,而且適用於未來的其他細胞療法。

  • Operator

    Operator

  • Our final question today is coming from Danielle Antalffy from UBS.

    我們今天的最後一個問題來自瑞銀集團的 Danielle Antalffy。

  • Danielle Joy Antalffy - Analyst

    Danielle Joy Antalffy - Analyst

  • It's good to be back talking to you all. Actually, just a quick question for you on the Orthopaedics number. A very good quarter. I was just wondering, I know this is really hard to parse out, but what is -- from your sense, what does backlog work down versus real underlying growth and/or more specific to J&J share gain? Anything you can say on how to think about what's happening in the Orthopaedics market right now in the U.S.

    很高興回來與大家交談。實際上,只是想問你一個關於骨科號碼的簡短問題。一個非常好的季度。我只是想知道,我知道這真的很難解析,但從你的角度來看,積壓與實際潛在增長和/或更具體的強生股票收益相比是什麼?關於如何思考目前美國骨科市場正在發生的事情,您可以說些什麼

  • Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

    Ashley A. McEvoy - Executive VP & Worldwide Chairman of MedTech

  • Thank you, Danielle. It's great to hear your voice. Listen, it's really a combination of both. Procedures are accelerating, particularly like even as recently as March in China, as an example, U.S. working through some of the backlog. So I do think that the market is in our favor.

    謝謝你,丹妮爾。很高興聽到你的聲音。聽著,這真的是兩者的結合。程序正在加速,尤其是最近的 3 月在中國,例如,美國正在處理一些積壓的案件。所以我確實認為市場對我們有利。

  • But at the same time, I have to give huge acknowledgment to the Orthopaedics team, who has really built a very differentiated portfolio. And they are now participating in the fastest-growing segments within the Orthopaedics category.

    但與此同時,我必須對骨科團隊表示衷心的感謝,他們確實建立了一個非常差異化的產品組合。他們現在正參與骨科類別中增長最快的細分市場。

  • So if the category is going 3 to 4, they're competing in areas that are high single digit. And what are those areas? It's all things robotics. It's around new sites of care like ASCs. It's around extremities.

    因此,如果類別是 3 到 4,他們將在高個位數的領域競爭。這些領域是什麼?都是機器人技術。它圍繞著像 ASC 這樣的新護理場所。它在四肢周圍。

  • I'm very pleased with our recent acquisition of CrossRoads, a foot and ankle. It's what we talked about around revision needs and cementless needs. Those are really the faster-growing segments in Orthopaedics, and we are well positioned to take advantage of that demand. Thank you for the question.

    我很高興我們最近收購了 CrossRoads,一隻腳和腳踝。這就是我們圍繞修訂需求和非水泥需求所討論的內容。這些確實是骨科增長更快的部分,我們有能力利用這一需求。感謝你的提問。

  • Jessica Moore - VP of IR

    Jessica Moore - VP of IR

  • Thank you, Danielle, and thanks to everyone for your questions and your continued interest in our company. We apologize to those that we couldn't get to because of time, but don't hesitate to reach out to the Investor Relations team with any remaining questions that you may have. Enjoy the rest of your day.

    謝謝你,丹妮爾,感謝大家提出的問題和對我們公司的持續關注。對於因時間原因我們無法聯繫到的人,我們深表歉意,但如有任何遺留問題,請隨時與投資者關係團隊聯繫。享受你剩下的一天。

  • Operator

    Operator

  • Thank you. This concludes today's Johnson & Johnson's First Quarter 2023 Earnings Conference Call. You may now disconnect.

    謝謝。今天的強生公司 2023 年第一季度收益電話會議到此結束。您現在可以斷開連接。