嬌生 (JNJ) 2023 Q3 法說會逐字稿

內容摘要

強生公司投資者關係副總裁傑西卡·摩爾 (Jessica Moore) 回顧了公司第三季度的業務成果和財務前景。

該公司在第三季度取得了強勁的業績,完成了 Kenvue 的分離,並提高了全年銷售額和每股收益指引。

他們專注於創新醫學和醫療技術業務,同時保持對患者的承諾。強生公司正在採取四管齊下的策略來解決滑石粉索賠問題,並對新的業務發展機會持開放態度。

他們在生產 CARVYKTI 療法方面取得了進展,並在臨床試驗中看到了有希望的結果。該公司有信心在 2025 年實現製藥業 570 億美元的目標。

他們對利潤率提高方面的進展感到高興,並預計 2024 年將有類似的業績。強生公司預計中國將出現強勁成長,並將其免疫產品組合視為成長的關鍵驅動力。

他們也專注於醫療技術的創新,特別是在機器人輔助手術方面。

總體而言,該公司相信他們在未來幾年的成長中處於有利地位。

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 Third Quarter 2023 Earnings Conference Call. (Operator Instructions) This call is being recorded. (Operator Instructions)

    早安,歡迎參加強生 2023 年第三季財報電話會議。 (操作員說明)此通話正在錄音。 (操作員說明)

  • I would now like to turn the call over to Johnson & Johnson. You may begin.

    我現在想把電話轉給強生公司。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 third quarter business results and full year financial outlook.

    早安.我是潔西卡摩爾,強生公司投資人關係副總裁。歡迎關注本公司對2023年第三季經營業績及全年財務展望的回顧。

  • 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.

    在我們詳細介紹之前,先介紹一些後勤工作。請注意,您可以在強生公司網站 Investor.jnj.com 的投資者關係部分找到更多資料,包括今天的簡報和相關時間表。

  • Please note that this presentation contains forward-looking statements regarding, among other things, the company's future operating and financial performance, market position and business strategy. 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 the date of this recording and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected. 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.

    請注意,本簡報包含有關公司未來營運和財務績效、市場地位和業務策略等的前瞻性陳述。請注意,不要依賴這些前瞻性陳述,這些陳述基於使用截至本記錄之日的可用資訊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,可能導致公司的實際結果有所不同實質上來自那些預計的。有關這些風險、不確定性和其他因素的描述可以在我們向 SEC 提交的文件中找到,包括我們的 2022 年 10-K 表格,該表格可在 Investor.jnj.com 和 SEC 網站上取得。

  • 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.

    此外,今天討論的幾種產品和化合物正在與策略合作夥伴合作開發或從其他公司獲得許可。這張投影片承認了這些關係。

  • Moving to today's agenda. I will start by reviewing the third quarter sales and P&L results for the corporation and highlights related to our two businesses. Joe Wolk, our CFO, will then provide additional business and financial commentary before sharing an overview of our cash position, capital allocation priorities and updated guidance for 2023.

    轉到今天的議程。我將首先回顧公司第三季的銷售和損益結果以及與我們兩項業務相關的亮點。然後,我們的財務長 Joe Wolk 將提供額外的業務和財務評論,然後概述我們的現金狀況、資本配置優先事項和 2023 年最新指導。

  • The remaining time will be available for your questions. Joaquin Duato, our Chairman and CEO; John Reed; and Ahmet Tezel, our Innovative Medicine and MedTech R&D leaders; as well as Erik Haas, our VP of Litigation, will be joining us for Q&A. To ensure we provide enough time to address your questions, we anticipate the webcast will last approximately 60 minutes.

    剩下的時間可以回答您的問題。 Joaquin Duato,我們的董事長兼執行長;約翰·里德;以及我們的創新醫學和醫療技術研發領導者 Ahmet Tezel;我們的訴訟副總裁 Erik Haas 將參加我們的問答。為了確保我們有足夠的時間來解決您的問題,我們預計網路廣播將持續約 60 分鐘。

  • As a reminder, on August 23, 2023, Johnson & Johnson announced the final results of the exchange offer and completion of the separation of Kenvue Inc. Unless otherwise stated, the financial results and guidance highlighted today reflect the continuing operations of Johnson & Johnson. We will report the Consumer Health financial results as discontinued operations. Additionally, going forward, the Pharmaceuticals segment will be referred to as Innovative Medicine.

    謹此提醒,強生公司於 2023 年 8 月 23 日宣布了換股要約的最終結果以及 Kenvue Inc 分拆的完成。除非另有說明,否則今天強調的財務業績和指引反映了強生公司的持續運營。我們將把消費者健康業務的財務表現報告為已終止業務。此外,今後,製藥部門將被稱為創新醫學。

  • Starting with Q3 2023 sales results. Worldwide sales were $21.4 billion for the third quarter of 2023, an increase of 6.8% versus the third quarter of 2022. Operational sales growth, which excludes the effect of translational currency, increased 6.4% as currency had a positive impact of 0.4 points. In the U.S., sales increased 11.1%. In regions outside the U.S., our reported growth was 1.6%. Operational sales growth outside the U.S. was 0.7%, with currency positively impacting our reported OUS results by 0.9 points.

    從 2023 年第三季的銷售結果開始。 2023 年第三季全球銷售額為 214 億美元,較 2022 年第三季成長 6.8%。由於匯率產生了 0.4 個百分點的正面影響,排除換算貨幣的影響,營運銷售額成長了 6.4%。在美國,銷售額成長了 11.1%。在美國以外的地區,我們報告的成長率為 1.6%。美國以外地區的營運銷售額成長了 0.7%,匯率對我們報告的 OUS 業績產生了 0.9 個百分點的正面影響。

  • It is important to note that operational sales in Europe were negatively impacted by the COVID-19 vaccine and loss of exclusivity of ZYTIGA. Excluding the net impact of acquisitions and divestitures, adjusted operational sales growth was 4.9% worldwide, 8.9% in the U.S. and 0.3% outside the U.S.

    值得注意的是,歐洲的營運銷售受到了 COVID-19 疫苗和 ZYTIGA 獨家經營權喪失的負面影響。排除收購和資產剝離的淨影響,調整後的全球營運銷售額成長率為 4.9%,美國為 8.9%,美國以外地區為 0.3%。

  • Turning now to earnings. For the quarter, net earnings were $4.3 billion, and diluted earnings per share was $1.69 versus diluted earnings per share of $1.62 a year ago. Excluding after-tax intangible asset amortization expense and special items for both periods, adjusted net earnings for the quarter were $6.8 billion and adjusted diluted earnings per share was $2.66, representing increases of 14.1% and 19.3%, respectively, compared to the third quarter of 2022. On an operational basis, adjusted diluted earnings per share increased 13.9%.

    現在轉向收益。該季度淨利潤為 43 億美元,稀釋後每股收益為 1.69 美元,而一年前稀釋後每股收益為 1.62 美元。剔除兩個時期的稅後無形資產攤銷費用和特殊項目,該季度調整後淨利潤為 68 億美元,調整後稀釋每股收益為 2.66 美元,分別較第三季度增長 14.1% 和 19.3%。2022年。在營運基礎上,調整後稀釋每股收益成長13.9%。

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

    我現在將評論業務銷售業績。除非另有說明,所引用的百分比代表與 2022 年第三季相比的營運銷售額變化,因此排除了貨幣換算的影響。

  • Beginning with Innovative Medicine. Worldwide Innovative Medicine sales of $13.9 billion increased 5.1% with growth of 10.9% in the U.S. and a decline of 2.3% outside of the U.S. Operational sales growth increased 4.3% as currency had a positive impact of 0.8 points. Excluding COVID-19 vaccine sales, worldwide operational sales growth was 8.2% with growth of 10.9% in the U.S. and growth of 4.3% outside of the U.S. Sales outside the U.S., excluding the COVID-19 vaccine, were negatively impacted by approximately 500 basis points due to the loss of exclusivity of ZYTIGA in Europe.

    從創新醫學開始。全球創新藥物銷售額達 139 億美元,成長 5.1%,其中美國成長 10.9%,美國以外地區下降 2.3%。由於匯率帶來 0.8 個百分點的正面影響,營運銷售額成長 4.3%。不包括 COVID-19 疫苗銷售,全球營運銷售成長 8.2%,其中美國成長 10.9%,美國以外成長 4.3%。美國以外的銷售(不包括 COVID-19 疫苗)受到約 500 個基數的負面影響由於ZYTIGA 失去在歐洲的獨家經營權而積分。

  • Innovative Medicine growth was driven by our key brands and continued uptake from our recently launched products, with 11 assets delivering double-digit growth. We continue to drive strong sales growth for both DARZALEX and ERLEADA with increases of 20.7% and 27%, respectively, due to continued share gains and market growth. Within Immunology, we saw growth in STELARA and TREMFYA with increases of 15.8% and 21.5%, respectively. This growth was predominantly driven by favorable patient mix and market growth.

    創新醫學的成長是由我們的主要品牌和我們最近推出的產品的持續吸收所推動的,有 11 項資產實現了兩位數的成長。由於份額持續成長和市場成長,我們繼續推動 DARZALEX 和 ERLEADA 的銷售強勁成長,分別成長 20.7% 和 27%。在免疫學領域,我們看到 STELARA 和 TREMFYA 的成長分別為 15.8% 和 21.5%。這一增長主要是由有利的患者組合和市場成長所推動的。

  • Turning to newly launched products. We continue to make progress on our launches of CARVYKTI and SPRAVATO. We are also encouraged by the early success of our launches of TECVAYLI and TALVEY, sales of which are driving the growth in other oncology. We expect to begin disclosing TECVAYLI sales in Q1 2024.

    轉向新推出的產品。我們在 CARVYKTI 和 SPRAVATO 的推出方面繼續取得進展。我們也對 TECVAYLI 和 TALVEY 的早期成功感到鼓舞,這兩種藥物的銷售正在推動其他腫瘤學的成長。我們預計將於 2024 年第一季開始揭露 TECVAYLI 銷售額。

  • Total Innovative Medicine sales growth was partially offset by the loss of exclusive of ZYTIGA and REMICADE, along with a decrease in IMBRUVICA sales due to competitive pressures.

    創新藥物總銷售額的成長被 ZYTIGA 和 REMICADE 獨家銷售的損失以及因競爭壓力導致 IMBRUVICA 銷售額下降所部分抵消。

  • I'll now turn your attention to MedTech. Worldwide MedTech sales of $7.5 billion increased to 10% with growth of 11.6% in the U.S. and 8.3% outside of the U.S. Operational sales growth increased 10.4% as currency had a negative impact of 0.4 points. Abiomed contributed 4.6% to operational growth. Excluding the impact of acquisition and divestitures, worldwide adjusted operational sales growth was 6%. On a pro forma basis, utilizing sales in the prior year from Abiomed as a stand-alone company, MedTech's growth for the quarter would be 6.4%.

    現在我將把你們的注意力轉向醫療科技。全球醫療科技銷售額為 75 億美元,成長 10%,其中美國成長 11.6%,美國以外成長 8.3%。 由於匯率負面影響 0.4 個百分點,營運銷售額成長 10.4%。 Abiomed 對營運成長貢獻了 4.6%。排除收購和資產剝離的影響,全球調整後營運銷售額成長率為 6%。根據預估,利用 Abiomed 作為獨立公司上一年的銷售額,MedTech 本季的成長率將為 6.4%。

  • MedTech was negatively impacted across all platforms by international sanctions in Russia worth approximately 60 basis points and volume-based procurement in China, primarily in 5 MedTech platforms: Spine, trauma, endocutters, energy and electrophysiology. As communicated last quarter, we saw the return to more normalized seasonality with moderate deceleration in the third quarter.

    由於俄羅斯國際制裁約 60 個基點以及中國的批量採購,所有平台的醫療技術均受到負面影響,主要集中在 5 個醫療技術平台:脊椎、創傷、內切刀、能源和電生理學。正如上個季度所傳達的那樣,我們看到第三季季節性回歸更加正常化,並出現適度減速。

  • The Interventional Solutions franchise delivered operational growth of 48.1%, which includes $311 million related to Abiomed. This reflects growth in Abiomed patient procedures in the high teens and continued strong adoption of Impella 5.5 technology in surgery. Electrophysiology is a major contributor to this growth with a double-digit increase of 20.3%. This reflects strong growth in all regions, including Europe, driven by our global market-leading portfolio, including the most recently launched QDOT RF ablation and OPTRELL mapping catheters.

    介入解決方案特許經營業務實現了 48.1% 的營運成長,其中包括與 Abiomed 相關的 3.11 億美元。這反映了 Abiomed 患者手術數量的成長以及 Impella 5.5 技術在手術中的持續強勁採用。電生理學是這一增長的主要貢獻者,增長了 20.3% 的兩位數。這反映出包括歐洲在內的所有地區的強勁成長,這得益於我們全球市場領先的產品組合(包括最近推出的 QDOT 射頻消融和 OPTRELL 標測導管)。

  • Operational growth of 3.2% in Surgery was driven primarily by procedure recovery and strength of our biosurgery and wound closure portfolios. Growth was partially offset by the impacts of volume-based procurement in China and supply challenges.

    外科手術業務成長 3.2%,主要是由於手術恢復以及我們生物外科和傷口閉合產品組合的實力。成長被中國批量採購和供應挑戰的影響部分抵消。

  • Global growth of 5.4% in Vision was driven by price actions in contact lenses and other as well as strength of new products, including ACUVUE OASYS 1-Day family of products in contact lenses and TECNIS Eyehance, our monofocal interocular lens in surgical vision. Growth of contact lenses was partially offset by strategic portfolio choices and supply challenges, although these continue to improve. Global Vision growth was negatively impacted by 100 basis points due to the Blink divestiture.

    全球視力成長 5.4% 是由隱形眼鏡和其他產品的價格走勢以及新產品的實力推動的,其中包括 ACUVUE OASYS 1-Day 系列隱形眼鏡產品和 TECNIS Eyehance(我們用於手術視力的單焦點人工水晶體)。隱形眼鏡的成長部分被策略性投資組合選擇和供應挑戰所抵消,儘管這些情況仍在繼續改善。由於 Blink 剝離,Global Vision 的成長受到了 100 個基點的負面影響。

  • Orthopedics operational growth of 2.6% reflects procedure growth; success of recently launched products, such as the global expansion of our VELYS digital solutions; and expansion in ambulatory surgical centers; partly offset by the impacts of volume-based procurement in China in spine and trauma.

    骨科業務成長 2.6% 反映了手術數量的成長;最近推出的產品取得成功,例如我們 VELYS 數位解決方案的全球擴張;並擴大門診手術中心;部分被中國批量採購對脊椎和創傷的影響所抵消。

  • Now turning to our consolidated statement of earnings for the third 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 margin was flat due to favorable patient mix and lower COVID-19 vaccine supply network-related exit costs in the Innovative Medicine business, partially offset by commodity inflation, unfavorable product mix and restructuring related to excess inventory costs in the MedTech business.

    現在轉向我們 2023 年第三季的合併損益表。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。由於創新醫學業務中有利的患者組合以及與COVID-19 疫苗供應網絡相關的退出成本較低,產品銷售利潤成本持平,但部分被商品通膨、不利的產品組合以及與醫療科技業務中的過剩庫存成本相關的重組所抵消。

  • Selling, marketing and administrative margins deleveraged 40 basis points, driven by increased expenses across enterprise. We continue to invest strategically in research and development at competitive levels, investing $3.4 billion or 16.2% of sales this quarter. R&D was leveraged by 120 basis points, primarily driven by portfolio prioritization, partially offset by higher milestone payments in the Innovative Medicine business. Additionally, IP R&D impairments were $206 million in the third quarter of 2023.

    由於整個企業支出增加,銷售、行銷和管理利潤率去槓桿化了 40 個基點。我們繼續在具有競爭力的水平上對研發進行策略性投資,本季投資 34 億美元,佔銷售額的 16.2%。研發槓桿率提高了 120 個基點,主要是由投資組合優先順序推動的,但部分被創新醫學業務更高的里程碑付款所抵消。此外,2023 年第三季智慧財產權研發減損額為 2.06 億美元。

  • Interest income was $182 million in the third quarter of 2023 as compared to $99 million of income in the third quarter of 2022. The increase in income was driven by higher interest rates earned on cash balances, partially offset by higher interest rates on debt balances.

    2023 年第三季的利息收入為1.82 億美元,而2022 年第三季的收入為9,900 萬美元。收入的增長是由現金餘額賺取的利率上升推動的,但部分被債務餘額利率上升所抵消。

  • The other income and expense line was an expense of $499 million in the third quarter of 2023 compared to an expense of $226 million in the third quarter of 2022. This was primarily driven by higher unrealized mark-to-market losses on public securities, partially offset by the lower COVID-19 vaccine-related exit costs and lower litigation expense.

    其他收入和支出項目 2023 年第三季的支出為 4.99 億美元,而 2022 年第三季的支出為 2.26 億美元。這主要是由於公共證券未實現的按市值計算的損失增加,部分原因是與COVID-19 疫苗相關的退出成本降低和訴訟費用降低所抵消。

  • Restructuring in the third quarter was $158 million, primarily related to the Innovative Medicine restructuring program announced in the first quarter.

    第三季重組金額為1.58億美元,主要與第一季宣布的創新醫學重組計畫相關。

  • Regarding taxes in the quarter. Our effective tax rate was 17.4% versus 16.7% in the same period last year. This increase was primarily driven by a non-deductible, non-recurring pretax charge that occurred in the current quarter. Excluding special items, the effective tax rate was 15.6% versus 15.9% in the same period last year.

    關於本季的稅收。我們的有效稅率為 17.4%,而去年同期為 16.7%。這一增長主要是由本季發生的不可扣除、非經常性稅前費用所推動的。不計特殊項目,實際稅率為15.6%,去年同期為15.9%。

  • As a result of the completion of the exchange offer, Johnson & Johnson is presenting the Consumer Health business financial results as discontinuing operations, including a gain of approximately $21 billion. I encourage you to review our upcoming third quarter 10-Q filing for additional details on specific tax and separation-related matters.

    交換要約完成後,強生公司將消費者健康業務作為終止經營業務公佈財務業績,其中包括約 210 億美元的收益。我鼓勵您查看我們即將發布的第三季 10-Q 備案文件,以了解有關特定稅務和離職相關事宜的更多詳細資訊。

  • Lastly, I'll direct your attention to the box 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,我將引導您注意幻燈片的方框部分,其中我們還提供了調整後的稅前收入、淨利潤和每股收益,以排除無形攤銷費用和特殊項目的影響。

  • Now let's look at adjusted income before tax by segment. In the third quarter of 2023, our adjusted income before tax for the enterprise as a percentage of sales increased from 35.3% to 37.6%, primarily driven by favorable patient mix in Innovative Medicine, partially offset by unfavorable product mix and commodity inflation in MedTech. Innovative Medicine margins improved from 41.4% to 45.4%, primarily driven by favorable patient mix and R&D portfolio prioritization. MedTech margins declined from 25% to 24.7%, primarily driven by commodity inflation and unfavorable product mix, partially offset by a divestiture gain.

    現在讓我們按部門查看調整後的稅前收入。 2023年第三季度,我們調整後的企業稅前收入佔銷售額的百分比從35.3%上升至37.6%,這主要是受到創新醫學領域有利的患者組合的推動,部分被醫療科技領域不利的產品結構和商品通膨所抵銷。創新醫學利潤率從 41.4% 提高至 45.4%,主要得益於有利的患者組合和研發組合優先順序。醫療科技利潤率從 25% 下降至 24.7%,主要是由於大宗商品通膨和不利的產品組合推動的,但部分被資產剝離收益所抵消。

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

    這就是強生公司第三季業績的銷售和獲利部分。我現在很高興將電話轉給喬·沃克。喬?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Thank you, Jessica, and thanks, everyone, for joining us today. This quarter's call marks a new era for Johnson & Johnson with a sharpened focus on Innovative Medicine and MedTech. What has remained consistent is our credo and our commitment to patients. We are privileged to build upon our 137-year legacy of tackling the world's most complex health care challenges and helping patients with serious unmet health needs around the world. As we look forward, we are well positioned to grow our business and innovate across the spectrum of health care. We are excited about what's ahead and what we can achieve in the future.

    謝謝傑西卡,也謝謝大家今天加入我們。本季度的電話會議標誌著強生公司進入了一個新時代,重點關注創新醫學和醫療技術。始終如一的是我們的信條和對病人的承諾。我們很榮幸能夠繼承 137 年的傳統,應對世界上最複雜的醫療保健挑戰,並幫助世界各地嚴重未滿足健康需求的患者。展望未來,我們處於有利地位,可以在醫療保健領域發展業務並進行創新。我們對未來以及未來能夠取得的成就感到興奮。

  • Before we dive into our performance, I want to briefly touch upon other items important to our business. The first is a brief recap of the Kenvue separation which was formally completed during the quarter. The transaction was executed within our targeted time frame and under budget while generating significant cash and value for our shareholders.

    在我們深入探討我們的業績之前,我想先簡單談談對我們業務重要的其他事項。第一部分是對本季度正式完成的 Kenvue 分離的簡要回顧。該交易在我們的目標時間範圍內並在預算範圍內執行,同時為我們的股東創造了大量現金和價值。

  • Through this separation, we raised $13.2 billion in cash proceeds through the Kenvue debt offering and IPO. We reduced Johnson & Johnson's outstanding share count by 191 million shares or approximately 7% without the use of cash and in a tax-free manner. We maintained our current quarterly dividend per share, and we retained approximately 180 million shares of Kenvue stock that provides cash proceeds for future flexibility. We will see the full impact to EPS of the share reduction in 2024.

    透過這次分離,我們透過 Kenvue 債務發行和 IPO 籌集了 132 億美元的現金收益。我們在不使用現金且以免稅方式的情況下,將強生公司的流通股數量減少了 1.91 億股,約 7%。我們維持目前的每股季度股息,並保留了約 1.8 億股 Kenvue 股票,為未來的靈活性提供了現金收益。我們將在 2024 年看到股份減持對每股盈餘的全面影響。

  • Another item warranting comment is the Inflation Reduction Act. We continue to believe the IRA's price-setting provisions are damaging to innovation and will prevent the delivery of transformative therapies and cures to patients. As we await adjudication of legal proceedings initiated by us and others, we did submit all requested information in compliance with CMS' drug price-setting scheme to continue supporting patients' access to our medicines that help them stay healthy and live longer.

    另一個值得評論的項目是《減少通貨膨脹法案》。我們仍然認為 IRA 的定價條款正在損害創新,並將阻礙向患者提供變革性療法和治癒方法。在我們等待我們和其他人發起的法律訴訟的裁決時,我們確實按照 CMS 的藥品定價計劃提交了所有要求的信息,以繼續支持患者獲得我們的藥物,幫助他們保持健康並延長壽命。

  • Moving to segment highlights in the quarter. As Jessica previously shared, our teams delivered strong results in the third quarter while continuing to advance our pipeline to enhance future growth.

    轉向本季的細分亮點。正如傑西卡之前分享的那樣,我們的團隊在第三季度取得了強勁的業績,同時繼續推進我們的產品線以促進未來的成長。

  • Within the Innovative Medicine business, two important regulatory milestones were announced during the quarter. Specifically, we received the European Commission approval for a reduced biweekly dosing frequency for TECVAYLI for eligible patients with relapsed and refractory multiple myeloma, and U.S. FDA and European Commission approval of TALVEY, a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma.

    在創新藥物業務中,本季宣布了兩個重要的監管里程碑。具體來說,我們獲得了歐盟委員會的批准,減少了符合條件的複發性難治性多發性骨髓瘤患者的TECVAYLI 每兩週一次的給藥頻率,以及美國FDA 和歐盟委員會批准了TALVEY,這是一種用於治療多發性骨髓瘤患者的一流雙特異性療法。大量預處理的多發性骨髓瘤。

  • Regarding clinical data, we are excited to have an unprecedented seven late-breaking abstracts, including three featured in the Presidential Symposium being presented at the European Society of Medical Oncology meeting this weekend. Highlights will include the results from all three Phase III studies of RYBREVANT in lung cancer, including MARIPOSA, MARIPOSA-2 and PAPILLON.

    關於臨床數據,我們很高興收到前所未有的七篇最新摘要,其中三篇是本週末在歐洲腫瘤內科學會會議上發表的主席研討會上的專題文章。重點內容將包括 RYBREVANT 治療肺癌的所有三項 III 期研究的結果,包括 MARIPOSA、MARIPOSA-2 和 PAPILLON。

  • Additionally, updated data from the SunRISe-1 study of TAR-200 in non-muscle-invasive bladder cancer will be shared, as well as the first-ever data of TAR-210 in patients with FGFR mutations.

    此外,還將分享 TAR-200 在非肌肉層浸潤性膀胱癌中的 SunRISe-1 研究的最新數據,以及 TAR-210 在 FGFR 突變患者中的首個數據。

  • We also look forward to presenting Phase II data for nipocalimab in rheumatoid arthritis at the American College of Rheumatology Annual meeting in November and have already launched a Phase II combination study in RA.

    我們也期待在 11 月的美國風濕病學會年會上展示尼泊卡利單抗治療類風濕關節炎的 II 期數據,並且已經啟動了 RA 的 II 期聯合研究。

  • Lastly, we plan to initiate multiple clinical development programs for our targeted oral peptide JNJ-2113. This includes the initiation of the ANTHEM Phase IIb study in ulcerative colitis, which will begin this month; and the Phase III clinical program titled ICONIC, for adults with moderate to severe plaque psoriasis, expected to begin in November.

    最後,我們計劃針對我們的標靶口服勝肽 JNJ-2113 啟動多個臨床開發項目。這包括啟動潰瘍性結腸炎的 ANTHEM IIb 期研究,該研究將於本月開始;名為 ICONIC 的 III 期臨床計畫預計將於 11 月開始,該計畫針對患有中度至重度斑塊型乾癬的成年人。

  • Moving to MedTech. Notable highlights in the quarter include significant advancements in electrophysiology across our cardiac ablation platform. We received FDA clearance for multiple atrial fibrillation ablation products in our portfolio to be used in a workflow without fluoroscopy. This FDA indication is unique to Johnson & Johnson and is a significant advancement where caregivers and patients are not exposed to harmful fluoroscopy-related radiation during their cardiac ablation procedures. It also allows for the removal of heavy lead protective equipment that may lead to orthopedic complications for care teams.

    轉向醫療科技。本季的顯著亮點包括我們的心臟消融平台在電生理學方面的重大進步。我們的產品組合中的多種心房顫動消融產品已獲得 FDA 批准,可用於無需透視的工作流程。 FDA 的這種適應症是強生公司獨有的,是一項重大進步,使護理人員和患者在心臟消融手術期間不會暴露於有害的透視相關輻射。它還允許拆除可能導致護理團隊出現骨科併發症的重型鉛防護設備。

  • In pulse field ablation, we have completed our clinical trial in Europe and submitted for CE Mark for our VARIPULSE catheter. We expect the completion for our U.S. VARIPULSE study to occur in the fourth quarter. We are also simultaneously advancing clinical studies for two additional pulse field ablation catheters, the STSF dual energy catheter capable of delivering both PF and RF energy through the same device; and OMNYPULSE, a large-tip focal catheter.

    在脈衝場消融方面,我們已經在歐洲完成了臨床試驗,並為我們的 VARIPULSE 導管提交了 CE 標誌。我們預計美國 VARIPULSE 研究將於第四季完成。我們也同時推進另外兩種脈衝場消融導管的臨床研究,即 STSF 雙能量導管,能夠透過同一設備提供 PF 和 RF 能量; OMNYPULSE,一種大尖端焦點導管。

  • Beyond electrophysiology, we have completed enrollment in the Abiomed Impella ECP clinical study, a landmark pivotal trial designed to demonstrate the safety and efficacy of the Impella ECP during high-risk PCI procedures. Impella ECP is the world's smallest heart pump and the only heart pump compatible with small-bore access and closure techniques.

    除了電生理學之外,我們還完成了 Abiomed Impella ECP 臨床研究的註冊,這是一項具有里程碑意義的關鍵試驗,旨在證明 Impella ECP 在高風險 PCI 手術中的安全性和有效性。 Impella ECP 是世界上最小的心臟泵,也是唯一與小口徑接入和閉合技術相容的心臟泵。

  • While not a clinical advancement, we have also taken steps in the quarter to improve MedTech's future margin profile, implementing a restructuring program designed to simplify and focus the operations of our Orthopedic business. As part of this 2-year program, we expect to exit certain markets and product lines across that business. We anticipate some short-term modest revenue deduction in Orthopedics of approximately $250 million in total over the next 2 years, given the market and product line exits, but believe these actions will improve our ability to meet demand, resulting in accelerated growth and enhanced profitability. The program is expected to be completed by the end of 2025 with total program costs estimated to be between $700 million and $800 million.

    雖然不是臨床進步,但我們在本季度也採取了措施來改善 MedTech 的未來利潤狀況,實施旨在簡化和集中我們骨科業務營運的重組計劃。作為這個兩年計畫的一部分,我們預計將退出該業務的某些市場和產品線。鑑於市場和產品線的退出,我們預計未來兩年骨科業務的短期收入將減少約 2.5 億美元,但相信這些行動將提高我們滿足需求的能力,從而加速成長並提高獲利能力。該計劃預計將於 2025 年底完成,計劃總成本估計在 7 億至 8 億美元之間。

  • Let's now turn to cash and capital allocation. We ended the third quarter with approximately $24 billion of cash and marketable securities and approximately $30 billion of debt for a net debt position of $6 billion. Free cash flow year-to-date through the third quarter was approximately $12 billion, up from the $5 billion we reported year-to-date in the second quarter of 2023.

    現在讓我們轉向現金和資本配置。第三季末,我們擁有約 240 億美元的現金和有價證券以及約 300 億美元的債務,淨債務部位為 60 億美元。今年迄今第三季的自由現金流約為 120 億美元,高於我們在 2023 年第二季報告的年初至今的 50 億美元。

  • Our capital allocation priorities remain unchanged. We will continue to execute a strategic and disciplined approach, utilizing our strong credit profile and robust free cash flow generation to prioritize continued investment in our business, increasing dividends on an annual basis, executing strategic business development initiatives for inorganic growth and executing share repurchases when appropriate.

    我們的資本配置重點維持不變。我們將繼續執行策略和紀律方法,利用我們強大的信用狀況和強勁的自由現金流生成,優先考慮對我們業務的持續投資,每年增加股息,執行無機增長的戰略業務發展計劃,並在適當的時候執行股票回購合適的。

  • Moving on to our 2023 guidance update. Based on the strong results delivered in the quarter and the first 9 months of this year, balanced with planned investments in the fourth quarter, we are raising the ranges for full year sales and EPS guidance. We now expect operational sales growth for the full year 2023 to be in the range of 8.5% to 9.0% or up $600 million at the midpoint in the range of $84.4 billion to $84.8 billion on a constant currency basis, and adjusted operational sales growth in the range of 7.2% to 7.7%.

    繼續我們的 2023 年指導更新。基於本季和今年前 9 個月的強勁業績,與第四季度的計劃投資相平衡,我們正在提高全年銷售額和每股收益指導範圍。我們現在預計 2023 年全年的營運銷售成長將在 8.5% 至 9.0% 之間,即以固定匯率計算,成長 6 億美元,中間值為 844 億美元至 848 億美元,調整後的營運銷售成長為範圍為7.2%至7.7%。

  • Just a reminder, our sales guidance continues to exclude any COVID-19 vaccine revenue. While we do not speculate on future currency movements, utilizing the euro spot rate as of last week at $1.06, we now anticipate an incremental negative currency impact of $400 million, resulting in a full year impact of negative 1% or $800 million.

    請注意,我們的銷售指南繼續不包括任何 COVID-19 疫苗收入。雖然我們不推測未來的貨幣走勢,但利用截至上週 1.06 美元的歐元即期匯率,我們現在預計貨幣負面影響將增加 4 億美元,從而導致全年負面影響 1% 或 8 億美元。

  • Looking across the P&L. Adjusted pretax operating margin is still expected to improve by approximately 50 basis points versus prior year, driven by stronger margin profile and business mix. Net other income is also being maintained, ranging from $1.7 billion to $1.9 billion. Due to higher interest rates earned on our cash, we now expect net interest income in the range of $300 million to $400 million. And finally, based on current tax law, our estimate for the effective tax rate for 2023 will be between 15.0% and 15.5%.

    縱觀損益表。在利潤率狀況和業務組合更強勁的推動下,調整後的稅前營業利潤率預計仍將較上年提高約 50 個基點。其他淨收入也維持在 17 億美元至 19 億美元之間。由於我們的現金利率較高,我們現在預計淨利息收入將在 3 億至 4 億美元之間。最後,根據現行稅法,我們預計 2023 年的有效稅率將在 15.0% 至 15.5% 之間。

  • These revised estimates translate to an increase in our adjusted operational earnings per share guidance by $0.10 at the midpoint. Our new range is $10.02 and to $10.08, or 12.5% growth at the midpoint; and adjusted reported earnings per share in the range of $10.07 to $10.13, or 13% growth at the midpoint.

    這些修訂後的估計意味著我們調整後的每股營運收益指引中位數增加了 0.10 美元。我們的新區間為 10.02 美元至 10.08 美元,即中點成長 12.5%;調整後的每股盈餘在 10.07 美元至 10.13 美元之間,中間值成長 13%。

  • Since January, we've been able to increase our guidance throughout the year for a cumulative impact of $3 billion on operational sales and $0.25 on adjusted operational earnings per share, which includes absorbing $0.10 for our licensing deal with Cellular Biomedicine Group announced in the second quarter of 2023.

    自1 月以來,我們已經能夠提高全年指導,對營運銷售額累計影響30 億美元,調整後每股營運收益0.25 美元,其中包括我們在第二季度宣布的與Cellular Biomedicine Group 的許可協議吸收0.10美元2023 年第四季。

  • Now I appreciate that many of you are turning your attention to 2024, and our team is actively finalizing our plans for next year. With that context, allow me to provide some preliminary perspectives for you to consider.

    現在,我很高興你們中的許多人將注意力轉向 2024 年,我們的團隊正在積極敲定明年的計劃。在此背景下,請容許我提供一些初步的觀點供您考慮。

  • For Innovative Medicine, we remain confident in our ability to deliver growth from key brands and anticipate continued progress from our newly launched products, all while advancing our robust pipeline with many exciting data readouts, filings and approvals ahead of us. This includes data presentation and regulatory submissions for TREMFYA in IBD, presenting data from our Phase III study of nipocalimab in myasthenia gravis and readouts from two Phase III ERLEADA trials in early stage prostate cancer. We do not expect entry of STELARA biosimilars in the United States during 2024. However, as a reminder, STELARA does have a composition of matter patent expiry in mid-2024 in Europe.

    對於創新醫學,我們對實現主要品牌成長的能力仍然充滿信心,並預計我們新推出的產品將繼續取得進展,同時透過許多令人興奮的數據讀出、備案和批准來推進我們強大的產品線。這包括 TREMFYA 治療 IBD 的數據展示和監管提交,展示了我們尼泊卡利單抗治療重症肌無力的 III 期研究的數據,以及早期前列腺癌的兩項 III 期 ERLEADA 試驗的讀數。我們預計 STELARA 生物相似藥不會在 2024 年進入美國。不過,提醒一下,STELARA 在歐洲的物質成分專利確實將於 2024 年中期到期。

  • For MedTech, we expect our commercial capabilities and continued adoption of recently launched products across all MedTech businesses will continue to drive our growth and improve competitiveness while continuing to advance our pipeline programs, including innovation in pulse field ablation, Abiomed and surgical robotics. We expect procedures in 2024 to remain consistent with elevated 2023 levels.

    對於MedTech 而言,我們預計我們的商業能力以及所有MedTech 業務中最近推出的產品的持續採用將繼續推動我們的成長並提高競爭力,同時繼續推進我們的管道項目,包括脈衝場消融、Abiomed 和手術機器人方面的創新。我們預計 2024 年的程序將與 2023 年提高的水準保持一致。

  • With respect to tax. As you may be aware, the European Union member states are in the process of enacting the EU's Pillar Two directive, which generally provides for a 15% minimum tax rate as established by the OECD Pillar Two framework. The first EU effective date for certain aspects of the law is January 1, 2024. As a result, we currently estimated up to a 1% tax rate increase in 2024. In addition, the U.S. Treasury's current perspective on Pillar Two will be harmful as it relates to the treatment of U.S. incentives for innovation and will result in U.S.-based multinational companies paying more tax revenue to foreign governments.

    關於稅收。如您所知,歐盟成員國正在製定歐盟第二支柱指令,該指令通常規定 OECD 第二支柱框架規定的 15% 最低稅率。該法某些方面的歐盟首個生效日期是2024 年1 月1 日。因此,我們目前估計2024 年稅率最多將增加1%。此外,美國財政部目前對第二支柱的看法將是有害的,因為它涉及美國對創新激勵措施的處理,並將導緻美國跨國公司向外國政府繳納更多稅收。

  • Regarding share count given the Kenvue separation. The full benefit of the approximately 191 million net share reduction in Johnson & Johnson shares outstanding from the exchange offer will be reflected in our 2024 financials.

    關於 Kenvue 分離後的股份數量。此次交換要約使強生公司流通股淨減少約 1.91 億股,其全部收益將反映在我們 2024 年的財務數據中。

  • And finally, while we don't speculate on future currency impact, utilizing the current euro spot rate would yield an approximate $0.15 negative currency impact on 2024 full year adjusted earnings per share.

    最後,雖然我們不推測未來的貨幣影響,但利用當前的歐元即期匯率將對 2024 年全年調整後每股收益產生約 0.15 美元的負面貨幣影響。

  • We are pleased with our strong performance during the first 9 months of this year and have positive momentum as we move into 2024. We look forward to sharing more about the strength of our business, promise of our Innovative Medicine and MedTech pipelines and the long-term strategy of Johnson & Johnson at our upcoming Enterprise Business Review on December 5 at the New York Stock Exchange. More information, including an overview of the day's schedule, will be shared shortly. We hope you will be able to join us either in person or on the available webcast.

    我們對今年前 9 個月的強勁表現感到滿意,並在邁入 2024 年時保持積極勢頭。我們期待更多地分享我們的業務實力、創新醫學和醫療技術產品線的承諾以及長期合作夥伴關係。我們將於12 月5 日在紐約證券交易所舉行的《企業商業評論》中介紹強生公司的長期策略。更多信息,包括當天日程安排的概述,將很快分享。我們希望您能夠親自或透過可用的網路廣播加入我們。

  • I want to conclude my remarks by thanking our teams around the world for their continued hard work and unwavering commitment to excellence on behalf of our patients. We are confident that our strategy will position us to deliver long-term growth and create significant value for our shareholders.

    在結束演講時,我想感謝我們世界各地的團隊為我們的患者所做的持續辛勤工作和對卓越的堅定承諾。我們相信,我們的策略將使我們能夠實現長期成長並為股東創造巨大價值。

  • With that, it's my pleasure to turn to Kevin and begin the Q&A portion of the call.

    至此,我很高興轉向凱文並開始電話的問答部分。

  • Operator

    Operator

  • (Operator Instructions) Our first question is coming from David Risinger from Leerink Partners.

    (操作員說明)我們的第一個問題來自 Leerink Partners 的 David Risinger。

  • David Reed Risinger - Senior MD

    David Reed Risinger - Senior MD

  • Congrats on the strong financial performance. So my question is on benchmarking MARIPOSA results, please. Could you share your thoughts on key considerations, including AstraZeneca's recent FLAURA2 results, which included a 9-month PFS benefit?

    祝賀強勁的財務業績。我的問題是關於 MARIPOSA 結果的基準測試。您能否分享您對關鍵考慮因素的看法,包括阿斯特捷利康最近的 FLAURA2 結果(其中包括 9 個月的 PFS 益處)?

  • John C. Reed - EVP of Pharmaceuticals, R&D

    John C. Reed - EVP of Pharmaceuticals, R&D

  • John Reed here. It's great to join the call. This is my first time as a newcomer to J&J. And before I answer your question, David, I would just like to say I have to tell you, I'm really enjoying being a new member of the J&J team. I've really been impressed with the culture inspired by our credo, with the caliber of our talent, our people here at J&J, and with the really strong performance of the pipeline.

    約翰·里德在這裡。很高興加入通話。這是我第一次當強生的新人。在回答你的問題之前,大衛,我想說我必須告訴你,我真的很高興成為強生團隊的新成員。我們的信條所激發的文化、強生的人才、員工以及產品線的強勁表現給我留下了深刻的印象。

  • We've already launched two NMEs this year, AKEEGA for prostate cancer and TALVEY for myeloma, continuing our tradition bringing new therapies in those agents. And we're positioned to deliver an average of more than two NMEs per year between now and the close of the decade, 2030. So the pipeline is very robust, and it's exciting to be here and to be a part of it.

    今年我們已經推出了兩種 NME,用於治療前列腺癌的 AKEEGA 和用於治療骨髓瘤的 TALVEY,繼續我們的傳統,為這些藥物帶來新療法。從現在到 2030 年這個十年結束時,我們的目標是平均每年提供兩個以上的 NME。因此,我們的產品線非常強大,能夠來到這裡並成為其中的一部分真是令人興奮。

  • So on to your question. The data will be presented at ESMO in a Presidential session, so we're embargoed until then. Abstracts will be available on Wednesday. I can only say that the RYBREVANT-lazertinib combo did perform well head-to-head against osimertinib. Our regimen is a chemo-free option for patients, which we think is important, and we'll present those data at ESMO.

    那麼關於你的問題。這些數據將在 ESMO 主席會議上公佈,因此在此之前我們將被禁止。摘要將於週三提供。我只能說 RYBREVANT-lazertinib 組合在與奧西替尼的正面交鋒中確實表現良好。我們的治療方案是患者的免化療選擇,我們認為這一點很重要,我們將在 ESMO 上展示這些數據。

  • Operator

    Operator

  • Next question today coming from Matt Miksic from Barclays.

    今天的下一個問題來自巴克萊銀行的馬特·米克西奇。

  • Matthew Stephan Miksic - Research Analyst

    Matthew Stephan Miksic - Research Analyst

  • I think most folks may look at the orthopedic results in medical devices as maybe being a little bit softer than expected, and I know that's not everything by a long shot for J&J. But given expectations were for kind of continued strength heading into Q3, if you could talk maybe a little bit about your comment on more traditional seasonality and thoughts on the sustainability of that strength, as well as the sort of divestiture and sort of realignment plan, Joe, that you described.

    我認為大多數人可能會認為醫療設備的整形外科結果可能比預期的要軟一些,而且我知道這對強生來說並不是全部。但考慮到對進入第三季度的持續強勢的預期,如果你能談談你對更傳統的季節性的評論和對這種強勢的可持續性的想法,以及某種剝離和某種重組計劃,喬,你所描述的。

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • So thank you for the question. And yes, I mean, our results in Orthopedics were 2.6% growth overall. And part of it, as you mentioned, is driven by seasonality. As we have commented, we are in a journey of improvement in Orthopedics. We want to be #1 and #2 in every segment we compete. And that is a place where we are not there yet, but we are very confident that we are going to continue to make improvements by investing and by growing in the highest-growth segments.

    謝謝你的提問。是的,我的意思是,我們在骨科領域的表現整體成長了 2.6%。正如您所提到的,其中一部分是由季節性驅動的。正如我們所評論的,我們正處於骨科的改進之旅中。我們希望在我們競爭的每個細分市場中成為第一和第二。我們還沒有達到這個目標,但我們非常有信心,我們將透過投資和在成長最快的領域發展來繼續取得進步。

  • We have made improvements in our portfolio. For example, on the [ME] side, we have a complete portfolio now. On the revision side, on the cementless side, we are launching now our VELYS Orthopedics total knee surgery replacement in Europe. And we already have about 30,000 procedures that have been performed with our VELYS robotic system.

    我們對我們的產品組合進行了改進。例如,在[ME]方面,我們現在擁有完整的產品組合。在翻修方面,在非骨水泥治療方面,我們現在正在歐洲推出我們的 VELYS Orthopedics 全膝關節置換手術。我們已經使用 VELYS 機器人系統執行了約 30,000 例手術。

  • Overall, we are increasing our penetration also in the ASCs, which is a fast-growing segment. And we see our performance continue to improve in the U.S. and globally. In this particular quarter, we also had some impact due to the impact of [value-based] procurement in China and also because of the impact of the Russia sanctions that was mentioned already in the prepared remarks.

    總體而言,我們正在提高在 ASC 中的滲透率,這是一個快速成長的細分市場。我們看到我們在美國和全球的業績持續改善。在這個特定的季度,由於中國[基於價值的]採購的影響以及準備好的發言中已經提到的俄羅斯制裁的影響,我們也產生了一些影響。

  • So overall, in Orthopedics, we are determined to continue our journey of improvement. We are focusing in having the right portfolio. We have a very strong team in the field. And as Joe has announced, and Joe can comment that we have a plan to be able to continue to improve our margins in Orthopedics.

    因此,總的來說,在骨科領域,我們決心繼續我們的改進之旅。我們專注於擁有正確的投資組合。我們在該領域擁有一支非常強大的團隊。正如喬所宣布的那樣,喬可以評論說,我們有一個能夠繼續提高骨科利潤率的計劃。

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Yes. Just very quickly, Matt. Thanks for the question. With respect to the restructuring program that we announced specifically in Orthopedics, we're looking to exit those less-profitable markets and product lines. So we'll have some, clearly, inventory write-downs as a result of that over the next 2 years. There will be some modest revenue disruption. But we actually do think these actions not only accelerate growth going forward, but will improve profitability.

    是的。很快,馬特。謝謝你的提問。關於我們在骨科領域專門宣布的重整計劃,我們希望退出那些利潤較低的市場和產品線。因此,很明顯,我們將在未來兩年內進行一些庫存減記。收入將會受到一些輕微的干擾。但我們實際上確實認為這些行動不僅會加速未來的成長,而且會提高獲利能力。

  • Operator

    Operator

  • Your next question is from Chris Shibutani from Goldman Sachs.

    您的下一個問題來自高盛的 Chris Shibutani。

  • Chris Shibutani - Research Analyst

    Chris Shibutani - Research Analyst

  • Can you provide us with some insight into updates on the talc litigation process?

    您能為我們提供一些有關滑石粉訴訟流程最新情況的見解嗎?

  • And then secondly, if you could just comment, Joe, you used the word voracious last time with your appetite for business development opportunities. How does that word stand, still, in terms of your appetite on the forward?

    其次,喬,如果你能評論一下,你上次用了「貪婪」這個詞來表達你對業務發展機會的渴望。就你對前鋒的興趣而言,這個詞仍然如何?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • So Erik, why don't I turn it over to you to discuss the talc litigation matter? And then I'll come back and answer Chris' second question.

    那麼艾瑞克,我為什麼不把滑石粉訴訟問題交給你來討論呢?然後我會回來回答克里斯的第二個問題。

  • Erik Haas

    Erik Haas

  • Great. Thanks, Joe. The short answer is that we continue to pursue the four-pronged strategy that we communicated back in July. So let me quickly summarize those four prongs and highlight the salient development and perhaps anticipate some follow-up questions about talc.

    偉大的。謝謝,喬。簡而言之,我們將繼續推行我們在 7 月傳達的四管齊下的策略。因此,讓我快速總結這四個方面,並強調其顯著的發展,或許還可以預測一些有關滑石粉的後續問題。

  • So the first prong, we are pursuing the appeal to the Supreme Court of the United States of the July ruling by the New Jersey Bankruptcy Court that dismissed LTL's bankruptcy case. Notably, our appeal recently was joined by counsel representing the vast majority of the talc claimants. Also thereafter, the bankruptcy court certified the case for a direct appeal to the Third Circuit, bypassing the District Court because the bankruptcy court found that the appeal raises matters of significant public interest, the resolution of which would materially advance the progress of the case, and we fully agree with that assessment.

    因此,首先,我們正在就新澤西州破產法院 7 月駁回 LTL 破產案的裁決向美國最高法院提出上訴。值得注意的是,代表絕大多數滑石粉索賠人的律師最近加入了我們的上訴。此後,破產法院認證該案件繞過地方法院直接向第三巡迴法院上訴,因為破產法院認為上訴提出了重大公共利益問題,該問題的解決將大大推進案件的進展,我們完全同意這一評估。

  • On the merit, the appeal challenges both the validity as well as the application of the novel standard that was imposed by the Third Circuit that requires a showing of "immediate financial distress" to proceed with the bankruptcy case. That immediate financial distress requirement, which the Third Circuit did not specifically define, is nowhere in the Bankruptcy Code and is contrary to the standards that are employed by other circuits. Moreover, under any reasonable interpretation of that standard, we believe the record has fully established that LTL faced immediate financial distress due to the large volume of talc claims that were asserted against it.

    就案情而言,上訴對第三巡迴法院施加的新標準的有效性和適用性提出了質疑,該標準要求表現出「立即財務困境」才能繼續破產案件。第三巡迴法院沒有具體定義這一立即財務困境要求,但它在《破產法》中沒有任何規定,並且與其他巡迴法院採用的標準相悖。此外,根據對該標準的任何合理解釋,我們認為記錄已充分證明 LTL 由於針對其提出的大量滑石索賠而面臨直接財務困境。

  • In terms of timing. The Third Circuit could rule at any moment whether it will take the direct appeal or not. If it does, we expect briefing to take place over the next couple of months with a decision in the early 2024 time frame. And because we do anticipate the Third Circuit will summarily affirm the application of its standards, we will immediately thereafter request the Supreme Court to resolve the circuit split and decide if the Third Circuit's novel approach is an appropriate standard for deciding a motion to dismiss. We do not think it is. We hope to squeeze the served petition to the Supreme Court into the first term in 2024. But if not, we will raise it in the second term.

    從時間安排上來說。第三巡迴法院可以隨時裁定是否接受直接上訴。如果確實如此,我們預計將在未來幾個月內進行簡報,並在 2024 年初做出決定。由於我們確實預期第三巡迴法院將立即確認其標準的適用,因此我們將立即請求最高法院解決巡迴法院的分歧,並決定第三巡迴法院的新穎方法是否是決定駁回動議的適當標準。我們不這麼認為。我們希望將向最高法院送達的請願書壓縮到2024年的第一屆任期內。但如果沒有,我們將在第二屆任期內提出。

  • The second prong of our strategy involves working with the counsel representing the vast majority of the talc payments, more than we had previously that were along with us, along with the -- and in addition to the future claims representatives. And together with the counsel and the future claims representatives, we're pursuing a consensual resolution of the talc claims through another bankruptcy. And that is exactly what the bankruptcy court, the New Jersey Bankruptcy Court, urged and strongly recommended that we do in its decision that actually dismissed the case. And the New Jersey Court made those recommendations having found that LTL had made remarkable progress towards an equitable and efficient resolution to date. So we are continuing on in that process.

    我們策略的第二個方面是與代表絕大多數滑石粉付款的律師合作,比我們以前與我們一起的律師以及未來的索賠代表一起合作。我們正在與律師和未來索賠代表一起,透過另一次破產尋求雙方同意的滑石索賠解決方案。這正是破產法院新澤西州破產法院在其實際上駁回此案的決定中敦促並強烈建議我們採取的做法。新澤西州法院提出這些建議是因為發現 LTL 迄今為止在公平有效的解決方案方面取得了顯著進展。所以我們正在繼續這個過程。

  • In terms of timing on the second prong. The consensual resolution is on the same trajectory as the initial bankruptcy plan with a vote expected in the next 6 months to determine whether the requisite supermajority of claimants support the plan.

    就第二爪的計時而言。協商一致的決議與最初的破產計劃的軌跡相同,預計將在未來 6 個月內進行投票,以確定是否獲得必要的絕大多數索賠人支持該計劃。

  • Third. While those negotiations are proceeding, we will continue to vigorously defend the meritless talc claims in the tort system. As you may have seen just this last week, we had a significant favorable ruling in that regard with the New Jersey's Appellate Court in the Barden case, reversing a $223 million verdict against the company.

    第三。在這些談判進行期間,我們將繼續大力捍衛侵權體系中毫無根據的滑石粉主張。正如您上週可能已經看到的那樣,新澤西州上訴法院在巴登案中做出了一項重大的有利裁決,推翻了針對該公司 2.23 億美元的判決。

  • The appellate court reversed because it determines the opinions of the leading plaintiff's experts were unsound, were unscientific and were unsubstantiated. And it is that baseless nature of those expert opinions why we have prevailed in the vast majority of the cases that have been tried to date.

    上訴法院推翻了原告的裁決,因為它認為主要原告專家的意見不合理、不科學且缺乏證據。正是這些專家意見毫無根據的性質,使得我們在迄今為止審理的絕大多數案件中獲勝。

  • In terms of timing of the litigation. There are two additional mesothelioma cases that we expect will be tried this year, with more to come in 2024. As with the Barden case, it's important to keep in mind that the ultimate resolution of those matters often is determined at the appellate level, not at the trial level, which is the place and which occur in the forms that the plaintiff lawyers choose.

    從訴訟時間來看。我們預計今年還將審理另外兩起間皮瘤案件,2024 年還會審理更多案件。與巴登案一樣,重要的是要記住,這些問題的最終解決方案通常是在上訴層面決定的,而不是在上訴層面決定的。在審判層面,這是原告律師選擇的地點和形式。

  • Finally, we will aggressively challenge the abuses of the judicial system by the mass tort claims bar and its experts, with our own affirmative litigation. We mentioned last time that we brought two actions against the plaintiff's bar's lead experts for defaming our talc products with publications premised on knowingly false propositions. And those are moving forward. They've been fully briefed with respect to the initial case motions. And in terms of timing, we expect ruling shortly from the Federal District Court in New Jersey whether those matters may proceed to the discovery phase.

    最後,我們將透過我們自己的平權訴訟,積極挑戰大規模侵權索賠律師協會及其專家濫用司法系統的行為。我們上次提到,我們對原告律師事務所的首席專家提起了兩項訴訟,因為他們在故意發表虛假主張的出版物中誹謗我們的滑石粉產品。這些正在向前推進。他們已經充分了解了最初的案件動議。就時間而言,我們預計新澤西州聯邦地方法院很快就會對這些事項是否可以進入證據開示階段做出裁決。

  • So that's a quick summary. I'd be happy to answer any follow-up questions you may have regarding the strategy.

    這是一個快速總結。我很樂意回答您有關該策略的任何後續問題。

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Great. Thank you, Erik. Chris, regarding your second question. If J&J had a nickel for every time voracious was quoted back to me since the second quarter earnings, we probably could have taken up guidance even a little bit more. And while that's often associated with wanting or devouring great quantities, I think it's really the second definition in Webster's, where having a very eager approach to an activity, the construct in which I meant that term in the second quarter.

    偉大的。謝謝你,埃里克。克里斯,關於你的第二個問題。如果自第二季財報以來,強生公司每次向我反饋「貪婪」的報價時都能得到五分錢,那麼我們可能會更多地接受指引。雖然這通常與想要或吞噬大量的東西聯繫在一起,但我認為這實際上是韋氏詞典中的第二個定義,即對一項活動有一種非常熱切的態度,我在第二季度的意思是這個術語的結構。

  • So we -- I could have said that 5 years ago, 10 years ago. My predecessors could have said that. We routinely, almost weekly, meet on new opportunities that may complement our existing portfolio or our future pipeline in both MedTech and Innovative Medicines, and the current moment is no different. In fact, we're in a very good position, given the low levels of net debt, the cash we were able to raise, to fulfill one of our capital allocation priorities, which you're probably very, very familiar with at this point in time.

    所以我們——我可以在 5 年前、10 年前就這麼說。我的前任可能會這麼說。我們幾乎每週都會定期會面,討論可能補充我們現有投資組合或未來在醫療科技和創新藥物領域的產品線的新機會,當前也不例外。事實上,考慮到淨債務水平較低,我們處於非常有利的位置,我們能夠籌集到現金,以實現我們的資本配置優先事項之一,此時您可能非常非常熟悉及時。

  • But we're not going to compromise our principles in making sure that it's a strategic fit. So it fits into the scientific expertise, the commercial capabilities or the global reach that will add value to that asset in our hands versus someone else. And we're going to make sure that we're disciplined in that approach financially by ensuring that we have a return that's commensurate with the risk that we're bearing on behalf of shareholders.

    但我們不會在確保戰略契合的原則上妥協。因此,它符合科學專業知識、商業能力或全球影響力,這將增加我們手中的資產相對於其他人的價值。我們將確保我們的回報與我們代表股東承擔的風險相稱,從而確保我們在財務上遵守這種方法。

  • So we'd much rather have an okay deal pass us by than make a bad deal. And that's kind of the principles that we'll live into. There's no deal that's too big, given our credit rating as well as our financial strength and annual cash flow generation. But as you know, we've had great success doing smaller earlier-stage deals as well.

    因此,我們寧願錯過一筆好的交易,也不願達成一筆糟糕的交易。這就是我們將遵循的原則。考慮到我們的信用評級、財務實力和年度現金流量,沒有什麼交易是太大的。但如您所知,我們在較小的早期交易方面也取得了巨大成功。

  • We're agnostic with respect to whether it be -- the next one being MedTech or Innovative Medicines. We are simply looking for the best qualified deal that meets both strategic and financial parameters. So hopefully, that answers your question.

    我們不知道下一個是醫療科技還是創新藥物。我們只是在尋找同時滿足策略和財務參數的最合格的交易。希望這能回答你的問題。

  • Operator

    Operator

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

    我們的下一個問題來自美國銀行的傑夫·米查姆。

  • Geoffrey Christopher Meacham - MD

    Geoffrey Christopher Meacham - MD

  • I'll stick with one. So on CARVYKTI, can you talk about the commercial backdrop just with respect to new centers or prescribers? And related on manufacturing, you guys have any update on the vector constraints and maybe when that could be relieved?

    我會堅持使用一個。那麼在 CARVYKTI 上,您能談談新中心或處方醫生的商業背景嗎?與製造相關,你們有關於向量約束的任何更新嗎?也許什麼時候可以緩解?

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • Thank you, Geoff. And as you have seen in the progression quarter-over-quarter of CARVYKTI, we continue to have, on one hand, strong demand; and on the other hand, progress in our manufacturing. We're also very encouraged by the data that came out with CARTITUDE-4 that eventually, we make CARVYKTI also a medicine in earlier lines of therapy.

    謝謝你,傑夫。正如您在 CARVYKTI 季度環比增長中所看到的那樣,我們一方面仍然有強勁的需求;另一方面,我們也看到了這一點。另一方面,我們的製造業取得了進步。我們也對 CARTITUDE-4 得出的數據感到非常鼓舞,最終我們使 CARVYKTI 也成為早期治療中的藥物。

  • So when it comes to our manufacturing progress, I'm going to let John explain what are we doing in order to be able to supply the strong demand that we are seeing in CARVYKTI today. Overall, what you can expect, Geoff, is that we -- you will continue to see quarter-over-quarter improvement in 2023 into also 2024.

    因此,當談到我們的製造進展時,我將讓約翰解釋我們正在做什麼,以便能夠滿足我們今天在 CARVYKTI 看到的強勁需求。總的來說,Geoff,您可以期待的是,您將在 2023 年和 2024 年繼續看到季度環比的改善。

  • John C. Reed - EVP of Pharmaceuticals, R&D

    John C. Reed - EVP of Pharmaceuticals, R&D

  • Yes, to follow-up on Joaquin's comments. We've been progressively adding more and more capacity. That's included at our original launch site in New Jersey, but we're close to having an additional manufacturing site up and rolling in Europe in Belgium, and also have recently increased our capacity by using some excess capacity that Novartis had to further bolster the number of slots that we can accommodate.

    是的,跟進華金的評論。我們一直在逐步增加越來越多的容量。這包括在我們位於新澤西州的最初發射基地,但我們即將在比利時的歐洲建立一個額外的生產基地,並且最近還通過使用諾華必須進一步增加數量的一些過剩產能來增加我們的產能我們可以容納的插槽數。

  • One of the traditionally rate-limiting components of the therapy has been the lentivirus component. And there, we've made really outstanding progress in-house mastering that technology, increasing the scale at our factory in Switzerland. And we're in the process -- we're building, and I think it will be available next year, another factory in the Netherlands to support the lentivirus component, which has sometimes been one of the rate-limiting aspects.

    傳統上該療法的限速成分之一是慢病毒成分。在那裡,我們在內部掌握該技術方面取得了非常出色的進展,擴大了瑞士工廠的規模。我們正在這個過程中——我們正在荷蘭建造另一家工廠,我認為它將在明年投入使用,以支持慢病毒成分,有時是限制速度的方面之一。

  • So altogether, the capacity continues to ramp up, and we continue to perfect the technology, I would say. Same thing with the number of centers that are qualified to administer the therapy, and we're also making progress on a number of countries where CARVYKTI will be available. So very excited, obviously, about the momentum with that. Really best-in-class CAR therapy.

    總而言之,我想說的是,產能持續增加,我們繼續完善技術。與有資格實施該療法的中心數量相同,我們也在一些將提供 CARVYKTI 的國家方面取得了進展。顯然,我對這種勢頭感到非常興奮。真正一流的 CAR 療法。

  • The CARTITUDE-4 data, as you know showed unprecedented progression-free survival benefit, a hazard ratio of 0.26, overall response rate of 99%, 86% complete response. Very durable for a one-and-done therapy that was well tolerated. The Grade 3 or above cytokine release syndrome was only 1.1%. So this is really, I think, now emerging as the preferred second-line therapy. And we hope to do more, such as bringing to front line as a possible alternative to stem cell transplant.

    如您所知,CARTITUDE-4 數據顯示了前所未有的無惡化存活獲益,風險比為 0.26,整體緩解率為 99%,完全緩解率為 86%。對於一種耐受性良好的一次性治療非常耐用。 3級或以上細胞激素釋放症候群僅佔1.1%。所以我認為,這現在確實成為首選的二線療法。我們希望做更多的事情,例如將其作為幹細胞移植的可能替代方案。

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • And Geoff, to your point, in multiple myeloma new product launches, we are also very encouraged by the launch of TECVAYLI and also the recent [approval] of TALVEY. The progression of these medicines is exceeding our internal expectations. And we already have about 2,000 health care professionals in the U.S. that are REMS-certified to be able to administer TECVAYLI and TALVEY. So very encouraging progress in these two medicines in multiple myeloma. And we expect to be able to break out TECVAYLI sales beginning in 2024.

    Geoff,就您的觀點而言,在多發性骨髓瘤新產品的發布中,我們也對 TECVAYLI 的推出以及最近 TALVEY 的[批准]感到非常鼓舞。這些藥物的進展超出了我們的內部預期。我們在美國已有約 2,000 名醫療保健專業人員經過 REMS 認證,能夠管理 TECVAYLI 和 TALVEY。這兩種藥物在治療多發性骨髓瘤方面取得了非常令人鼓舞的進展。我們預計 TECVAYLI 的銷售將從 2024 年開始突破。

  • Operator

    Operator

  • Your next question is coming from Josh Jennings from TD Cowen.

    您的下一個問題來自 TD Cowen 的 Josh Jennings。

  • Joshua Thomas Jennings - MD & Senior Research Analyst

    Joshua Thomas Jennings - MD & Senior Research Analyst

  • Was hoping to ask on STELARA and the biosimilar competition in the U.S. now expected in 2025. That's not new news. But wanted to check in on how beneficial is the extra year for the Innovative Medicine business' defense strategy? I guess, focusing on just the potential for TREMFYA to take share from STELARA in psoriasis and psoriatic arthritis and inflammatory bowel disease indications. And does timing shift provide more confidence in the potential hit to constant currency revenue target set for 2025 for the pharma unit?

    希望詢問 STELARA 以及目前預計 2025 年在美國進行的生物相似藥競爭。這不是什麼新消息。但想了解額外的一年對創新醫學業務的防禦策略有多大好處?我想,重點關注的是 TREMFYA 在銀屑病、銀屑病關節炎和發炎性腸道疾病適應症方面從 STELARA 手中奪取份額的潛力。時間轉變是否讓製藥部門對實現 2025 年固定貨幣收入目標的潛在影響更有信心?

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • Thank you for the question. Certainly, we have always been very confident in being able to hit our $57 billion target in 2025 for pharma. As I have explained before, there are a number of factors there are. The first one and most important is the growth that we're having in our key assets: TREMFYA; ERLEADA; UPTRAVI; our long-acting injectables; and especially DARZALEX, which continue to have a tremendous trajectory gaining share in first line. We are encouraged, as I just commented, by the launches of CARVYKTI; the progression of SPRAVATO; and also the recent launches, too, also in multiple myeloma of TECVAYLI and TALVEY.

    感謝你的提問。當然,我們一直對 2025 年能夠實現 570 億美元的製藥目標充滿信心。正如我之前所解釋的,有很多因素。第一個也是最重要的是我們的關鍵資產的成長:TREMFYA;埃爾利達;烏普特拉維;我們的長效注射劑;尤其是 DARZALEX,其在一線市場的份額繼續以驚人的速度成長。正如我剛才所說,CARVYKTI 的推出令我們深受鼓舞; SPRAVATO 的進展;還有最近推出的 TECVAYLI 和 TALVEY 治療多發性骨髓瘤的藥物。

  • And looking into 2024, the remainder of the year, and also into 2025, we have some very exciting news in our pipeline. Some of them have been already commented. For example, the first chemo-free regimen as first-line in EGFR-mutated non-small lung cancer. We will be presenting the data of MARIPOSA in -- at ESMO, and that potentially will be a filing and an approval in 2025. This would be a new standard of therapy in this line of therapy in this very important need for patients.

    展望 2024 年、今年剩餘時間以及 2025 年,我們正在準備一些非常令人興奮的消息。其中一些已經發表了評論。例如,首個作為 EGFR 突變非小細胞肺癌一線治療的無化療方案。我們將在 ESMO 上展示 MARIPOSA 的數據,這可能會在 2025 年進行備案和批准。這將是該療法的新標準,滿足患者的這一非常重要的需求。

  • We also continue to be encouraged by the progress in our TARIS drug delivery platform. You are also going to see data being presented at ESMO. Very important for us, in two existing products, we will be presenting data on TREMFYA in IBD, both in Crohn's and in ulcerative colitis, for a potential approval later in 2024. That's going to be a very significant growth driver for TREMFYA. Take into consideration that in the STELARA case, IBD represents 75% of the sales.

    我們也持續對 TARIS 藥物輸送平台的進展感到鼓舞。您還將看到 ESMO 上展示的數據。對我們來說非常重要的是,在兩款現有產品中,我們將提供TREMFYA 在IBD(克羅恩病和潰瘍性結腸炎)中的數據,以便於2024 年晚些時候獲得批准。這將成為TREMFYA 非常重要的成長動力。考慮到在 STELARA 案例中,IBD 佔銷售額的 75%。

  • So we still have a lot of growth in front of us with TREMFYA as we do also in ERLEADA, in which we will present data in localized high-risk prostate cancer. We're also going to be able to present some data of nipocalimab in myasthenia gravis, end of this year. So all in all, very good news for our pipeline in 2024 and 2025.

    因此,我們的 TREMFYA 仍然有很大的成長空間,就像我們在 ERLEADA 中所做的那樣,我們將在其中展示局部高風險前列腺癌的數據。今年底,我們也將能夠提供尼泊卡利單抗治療重症肌無力的一些數據。總而言之,這對我們 2024 年和 2025 年的管道來說是非常好的消息。

  • Certainly, the entrance of the biosimilars in 2025 in the U.S. is another factor that builds our confidence that we are going to be able to meet the $57 billion.

    當然,生物相似藥將於 2025 年進入美國是增強我們信心的另一個因素,讓我們相信我們將能夠實現 570 億美元的目標。

  • For me, the most important thing now is to look forward and to think about the growth profile of our Innovative Medicine group into the second half of the decade. We have a number of growth drivers that are already there that I've described, but also the strength of our pipeline, both in immunology, in oncology and in neuroscience, profiles us as a strong company that has a strong growth profile into the second half of the decade. And that's part what we will be looking forward to discussing with you in our upcoming enterprise business review, focusing what is going to be the growth profile in the second half of the decade.

    對我來說,現在最重要的是展望並思考我們創新醫學集團在本世紀下半葉的成長狀況。正如我所描述的,我們已經擁有許多成長動力,而且我們在免疫學、腫瘤學和神經科學領域的產品線實力也使我們成為一家強大的公司,在第二季度具有強勁的成長勢頭。十年的一半。這就是我們期待在即將到來的企業業務回顧中與您討論的部分內容,重點關注本十年後半段的成長概況。

  • Operator

    Operator

  • Next question is coming from Chris Schott from JPMorgan.

    下一個問題來自摩根大通的克里斯·肖特。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Maybe, Joe, just a little bit more color on 2024. I appreciate the details you provided, seems like a year of another healthy top line growth. But can you just give us some directional color on margins next year? I know there are some dis-synergies with Kenvue this year. I'm just trying to get a sense of how you think about margin progression here as you kind of balance some of these, kind of the pipeline opportunities and some of these top line growth initiatives, versus kind of dropping that to the bottom line. So just any directional color would be appreciated.

    喬,也許 2024 年會更加豐富多彩。我很欣賞你提供的細節,看起來又是營收健康成長的一年。但你能給我們一些關於明年利潤的方向性色彩嗎?我知道今年與 Kenvue 存在一些不協同效應。我只是想了解您如何看待這裡的利潤增長,因為您在平衡其中一些、管道機會和一些頂線增長計劃時,而不是將其降至底線。所以任何方向性的顏色都會受到讚賞。

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • Yes. Sure, Chris. Thanks for the question. So first off, we're very pleased with the margin progress that we've been able to make in 2023. I think we started the year to -- roughly flat to now improving by 50 basis points. A lot of that has really gone -- is directly attributable to the efforts of many people in the organization who really took the to look at our infrastructure as a two-segment company versus a three-segment company.

    是的。當然,克里斯。謝謝你的提問。首先,我們對 2023 年的利潤率進展感到非常滿意。我認為我們年初的利潤率大致持平,現在提高了 50 個基點。其中許多確實已經消失,這直接歸功於組織中許多人的努力,他們真正將我們的基礎設施視為兩部門公司與三部門公司。

  • So the dis-synergies that we warned about and talked about early on in the Kenvue separation process really haven't come to manifest. In fact, as we look out to 2024, we see minimal to almost no impact from dis-synergies from the separation. We are in the process of finalizing our business plans for 2024. I'd like to get a little bit better assessment of how the clinical development pipeline is shaping up, what the investments are required there.

    因此,我們在 Kenvue 分離過程中早期警告和談論的反協同效應實際上還沒有顯現出來。事實上,展望 2024 年,我們認為分離帶來的綜效影響極小甚至幾乎沒有。我們正在最終確定 2024 年的業務計劃。我希望更好地評估臨床開發管道的形成以及那裡需要哪些投資。

  • But we're a larger company. We take the opportunity to look each and every year at efficiencies. So we're not in a position to give you margin guidance right now, but I would expect that something similar to where we started this year would not be a bad starting point for next year. Again, it's going to depend on the investments that the R&D teams from both MedTech and Innovative Medicines can bring forth. And we'll obviously look to accelerate bringing some great products to patients sooner if we have that opportunity.

    但我們是一家更大的公司。我們每年都會藉此機會審視效率。因此,我們現在無法為您提供保證金指導,但我預計與我們今年開始的情況類似的情況對於明年來說不會是一個糟糕的起點。同樣,這將取決於醫療科技和創新藥物研發團隊所能帶來的投資。如果有機會的話,我們顯然會加快速度,更快地為患者提供一些優質產品。

  • Operator

    Operator

  • Your next question is coming from Larry Biegelsen from Wells Fargo.

    你們的下一個問題來自富國銀行的拉里·比格爾森。

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

    Lawrence H. Biegelsen - Senior Medical Device Equity Research Analyst

  • Joe, just -- could you just clarify what you meant by flat procedures in '24 in MedTech? Are you assuming -- does that mean flat in MedTech growth? And just for my question, can you talk about what you're seeing with bariatrics? For GLP-1, this is. And how you're thinking about the potential impact of GLP-1s across your device business, long term, especially in cardio and ortho?

    Joe,您能否澄清一下 24 年 MedTech 中的扁平程序是什麼意思?您是否假設—這是否意味著醫療科技成長持平?對於我的問題,您能談談您對減肥治療的看法嗎?對 GLP-1 來說,是這樣的。您如何看待 GLP-1 對您的設備業務的長期潛在影響,特別是在有氧運動和矯形方面?

  • Joseph J. Wolk - Executive VP & CFO

    Joseph J. Wolk - Executive VP & CFO

  • So I'll give the second half of that question to Joaquin, but thanks for the clarifying question with respect to market growth. We are not suggesting flat market -- or flat market in MedTech next year. What we do is -- are foreseeing right now, based on what we know today, is the elevated levels, the market overall being 5% to 7% versus what traditionally has been maybe 4% to 6%. We see that same 5% to 7% next year.

    因此,我將把這個問題的後半部分交給華金,但感謝您澄清有關市場成長的問題。我們並不是建議明年醫療科技市場持平。我們所做的是——根據我們今天所知道的情況,目前的預測是更高的水平,市場整體為 5% 至 7%,而傳統上可能為 4% 至 6%。我們預計明年也會有 5% 到 7% 的成長。

  • Joaquin?

    華金?

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • Thank you, Larry. And taking a step back, we see the evolution of our MedTech business in a very positive way. One of our key goals for us is to be a top-tier grower in MedTech. When I look at the results of MedTech this year, we are delivering on that. Our growth in the quarter pro forma was 6.4% when you compare with Abiomed as a stand-alone company. And when you look at our pro forma growth year-to-date in MedTech, it's 7.9%.

    謝謝你,拉里。退一步來說,我們看到醫療科技業務正在以非常積極的方式發展。我們的主要目標之一是成為醫療科技領域的頂級種植者。當我看到今年 MedTech 的業績時,我們正在兌現這一目標。與 Abiomed 作為獨立公司相比,我們預計本季的成長率為 6.4%。當你看到我們今年迄今為止在醫療科技領域的預估成長率時,你會發現它是 7.9%。

  • So very pleased with the performance of our MedTech business. And we have expectations to continue our progression into 2024, in part fueled by the procedural growth that we see and also by our continued improvement in our execution and the launch of new products. Some of them we can discuss later. For example, we will be launching our first PFA catheter in Europe into 2024.

    對我們醫療技術業務的表現非常滿意。我們預計到 2024 年將繼續取得進展,部分原因是我們所看到的程式成長,以及我們在執行方面的持續改進和新產品的推出。其中一些我們可以稍後討論。例如,我們將於 2024 年在歐洲推出第一款 PFA 導管。

  • When it comes to GLP-1s, it's good for patients to have new options for treatment, especially in obesity, which, at times, has been a stigmatized disease in which patients were not looking for treatment due to the stigmatization of that. Certainly, as you commented, we're seeing some impact in our bariatric business in the short term as some patients are reconsidering surgery, expecting to get treatment.

    當談到 GLP-1 時,患者有新的治療選擇是件好事,尤其是對於肥胖症,肥胖有時是一種被污名化的疾病,患者因為這種污名化而不會尋求治療。當然,正如您所評論的,我們的減肥業務在短期內會受到一些影響,因為一些患者正在重新考慮手術,希望得到治療。

  • But overall, when we talk to surgeons, bariatric surgeons, what is a complementary role of surgery and GLP-1s and many of them comment on the fact that they could see a tailwind for bariatric surgery down the road given this complementary nature, the increased awareness about obesity, more patients seeking treatment. And many of the patients, about 30% of them, are not going to be tolerating these medications, so they would be another funnel for our bariatric business.

    但總體而言,當我們與外科醫生、減肥外科醫生交談時,手術和GLP-1 的互補作用是什麼,他們中的許多人評論說,鑑於這種互補性,他們可能會看到減肥手術的順風車。對肥胖的認識,更多的病人尋求治療。許多患者(約 30%)不會耐受這些藥物,因此它們將成為我們減肥業務的另一個管道。

  • In the rest of our MedTech business, at this point, we continue to see robust procedure increase, and we don't anticipate that change that -- think that then changing in the foreseeable future.

    在我們的其他醫療技術業務中,目前,我們繼續看到程序的強勁增長,我們預計不會發生這種變化 - 認為在可預見的未來會發生變化。

  • Operator

    Operator

  • Next question is coming from Terence Flynn from Morgan Stanley.

    下一個問題來自摩根士丹利的特倫斯·弗林。

  • Terence C. Flynn - Equity Analyst

    Terence C. Flynn - Equity Analyst

  • I was just wondering if you could elaborate a little bit more, John, on nipocalimab in RA. I know we're going to see the full data here at ACR. But is this a drug that you see potentially working in a broad population? Or is there a biomarker subset, group, that's more likely to respond? And then how are you thinking about Phase III plans here in this indication?

    約翰,我只是想知道您能否詳細闡述 RA 中的尼泊卡利單抗。我知道我們將在 ACR 上看到完整的數據。但您認為這種藥物可能對廣泛人群有效嗎?或者是否存在更有可能產生反應的生物標記子集、群體?那麼您如何看待這個跡像中的第三階段計劃?

  • John C. Reed - EVP of Pharmaceuticals, R&D

    John C. Reed - EVP of Pharmaceuticals, R&D

  • Yes. Thanks for the question, and we look forward to sharing those data at the ACR in November in San Diego. The -- we're looking at nipo as either a monotherapy, combined with a precision medicine strategy, or as a combination for a broad population where we aim to combine with an anti-TNF agent. And we see those two mechanisms as being very complementary, reducing the levels of autoantibodies with nipo, and then inhibiting inflammatory mechanisms with the TNF. That so-called DAISY study, the Phase II, is underway now, and we'll test that combination.

    是的。感謝您提出問題,我們期待 11 月在聖地牙哥的 ACR 上分享這些數據。我們將 nipo 視為單一療法,與精準醫療策略相結合,或作為針對廣泛人群的組合療法,我們的目標是與抗 TNF 藥物相結合。我們認為這兩種機制非常互補,用 nipo 降低自體抗體水平,然後用 TNF 抑制發炎機制。所謂的 DAISY 研究,即第二階段,現在正在進行中,我們將測試這種組合。

  • So that, in general, has been the way we're looking at RA, not only for nipo, but other agents in our pipeline, where we see the future being monotherapies that are targeted in a precision medicine way or broad therapies that are combos that can bring together synergistic mechanisms in a safe way.

    因此,總的來說,這就是我們看待 RA 的方式,不僅適用於 nipo,也適用於我們管道中的其他藥物,我們認為未來是以精準醫學方式針對的單一療法或以組合方式進行的廣泛療法可以以安全的方式整合協同機制。

  • We're excited to be launching the DAISY program to look at that combo. And we're hoping that, that will bring deeper, more durable remissions for patients as we bring those new mechanisms together.

    我們很高興能夠啟動 DAISY 計劃來研究這個組合。我們希望,當我們將這些新機制結合在一起時,這將為患者帶來更深入、更持久的緩解。

  • Operator

    Operator

  • Next question is coming from Joanne Wuensch from Citibank.

    下一個問題來自花旗銀行的 Joanne Wuensch。

  • Joanne Karen Wuensch - MD

    Joanne Karen Wuensch - MD

  • Is it possible to give us a little bit more detail on a couple of things? You mentioned headwinds from VBP. And I'm just curious if there's, a, a way to quantify it? And b, a way to say if it's at least better or worse or the same as it has been in the last couple of quarters?

    能否為我們提供一些更詳細的資訊?您提到了 VBP 的不利因素。我只是好奇是否有一種方法可以量化它? b,如何判斷情況是否至少比過去幾季更好、更差或相同?

  • And then similarly in other aspects of China, we've been hearing a lot about anti-corruption policies, et cetera. If you could comment on that, that would be great.

    同樣,在中國的其他方面,我們也聽到了很多有關反腐敗政策等的內容。如果您能對此發表評論,那就太好了。

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • Thank you, Joanne. And first, let me say that China for us is a key market and a market in which we are delivering growth now, and we are going to continue to deliver strong growth into 2024. So it's a key growth driver for us.

    謝謝你,喬安妮。首先,我要說的是,中國對我們來說是一個關鍵市場,也是我們現在正在實現成長的市場,我們將在 2024 年繼續強勁成長。因此,它是我們的關鍵成長動力。

  • So on one hand, certainly, VBP represents a headwind in price. And on the other hand, it also represents an opportunity as you can expand quality products, medical technologies into more patients. So there are a number of MedTech platforms now currently undergoing VBP headwinds, electrophysiology, spine, trauma, endocutters and energy. And these effects will last during 2023 and part of 2024. We have already anniversary our large joints VBP, so at this point, we have about 80% of our platforms that have been already affected by VBP. Again, as we look into 2024, we expect continue to deliver a strong growth in China and China remaining a key part of our growth.

    因此,一方面,VBP 無疑代表著價格的逆風。另一方面,它也代表著一個機會,因為您可以將優質產品、醫療技術擴展到更多患者。因此,目前有許多醫療技術平台正在經歷 VBP、電生理學、脊椎、創傷、內切刀和能源方面的逆風。這些影響將持續到 2023 年和 2024 年的部分時間。我們已經迎來了大型關節 VBP 週年紀念日,所以目前我們大約 80% 的平台已經受到了 VBP 的影響。展望 2024 年,我們再次預期中國將繼續強勁成長,並且中國仍然是我們成長的關鍵部分。

  • When it comes to question that you were asking in anti-corruption side, we have a strong culture of compliance in our business. And at this point, we may see some limitations related to physician and surgeon access, but we are not seeing any material impact in any part of our business due to that, and we'll continue to monitor the situation. Overall, as I said, we continue to see China as a key driver of our growth and also as a key source of innovation moving into the future.

    當談到您在反腐敗方面提出的問題時,我們的業務有很強的合規文化。目前,我們可能會看到與醫生和外科醫生的准入相關的一些限制,但我們沒有看到因此對我們業務的任何部分產生任何實質影響,我們將繼續監控情況。總的來說,正如我所說,我們仍然將中國視為我們成長的關鍵驅動力,也是走向未來的創新的關鍵來源。

  • Operator

    Operator

  • Your next question is coming from Vamil Divan from Guggenheim Securities.

    您的下一個問題來自古根漢證券公司的瓦米爾·迪萬。

  • Vamil Kishore Divan - Research Analyst

    Vamil Kishore Divan - Research Analyst

  • Great. I just want to maybe dive a little deeper on the immunology side. Appreciate some of the comments you made there already. But for the quarter, the performance was very strong for several of your products there. So I'm just curious if there were any sort of onetime items there that we should be aware of. It sounded like it was a lot about patient mix and market growth that you guys were commenting on. I'm curious if you can just highlight any major stocking or sort of onetime pricing adjustments that we should take into account as we look at future quarters.

    偉大的。我只是想在免疫學方面更深入一些。感謝您已經在那裡發表的一些評論。但在本季度,你們的幾種產品的表現非常強勁。所以我只是好奇是否有任何我們應該注意的一次性物品。聽起來你們評論的內容很多是關於患者組合和市場成長的。我很好奇您能否強調我們在展望未來幾季時應考慮到的任何主要庫存或一次性定價調整。

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • Thank you. We are very pleased with the performance of our immunology business. Especially, we're pleased with the performance of TREMFYA with 25.1% growth in the quarter, which shows our ability to drive growth there. As I said before, TREMFYA currently is now indicated in psoriatic arthritis and psoriasis. As an analog, in the case of STELARA, that represents about 25% of the sales.

    謝謝。我們對免疫學業務的表現非常滿意。尤其是,我們對 TREMFYA 本季成長 25.1% 的業績感到滿意,這表明我們有能力推動該領域的成長。正如我之前所說,TREMFYA 目前適用於乾癬性關節炎和乾癬。與此類似,就 STELARA 而言,這約佔銷售額的 25%。

  • So with the upcoming readouts, filing and potential approvals of ulcerative colitis and Crohn's disease, we expect to have significant growth in TREMFYA. We talk about TREMFYA as a $5 billion product earlier in our Analyst Day in 2021. Now you can see clearly that we're going not only to meet that, but to clearly exceed that benchmark for TREMFYA.

    因此,隨著潰瘍性結腸炎和克羅恩病即將公佈、備案和潛在批准,我們預計 TREMFYA 將顯著增長。我們在 2021 年分析師日早些時候將 TREMFYA 視為一款價值 50 億美元的產品。現在您可以清楚地看到,我們不僅要滿足這一目標,而且要明顯超過 TREMFYA 的基準。

  • So when it comes to STELARA, we had also a very robust growth of close to 16%. In that case, there is a prior period adjustment in the quarter a year ago that represents about 600 basis points. So you should take that into consideration when you think about the STELARA growth.

    因此,就 STELARA 而言,我們也實現了接近 16% 的強勁成長。在這種情況下,一年前該季度的前期調整約為 600 個基點。因此,當您考慮 STELARA 的成長時,您應該考慮到這一點。

  • We are very pleased overall, as I said, with our immunology portfolio. Overall, our immunology portfolio in the quarter grew 12.4%, which is very strong considering that we also have headwinds there of REMICADE biosimilars.

    正如我所說,我們總體上對我們的免疫學產品組合非常滿意。總體而言,本季度我們的免疫學產品組合成長了 12.4%,考慮到我們在 REMICADE 生物相似藥方面也面臨阻力,這一增長非常強勁。

  • And we remain very excited about the immunology portfolio as a key driver for J&J. Our Innovative Medicines are going to be bringing significant improvements in IBD with TREMFYA, as I recall. But also staying there, we have our target oral peptide which is going to be presenting some data soon, that we already presented data in psoriasis. And also, we have the combination of guselkumab and golimumab in IBD, which has presented also groundbreaking.

    我們仍然對免疫學產品組合作為強生的關鍵驅動力感到非常興奮。我記得,我們​​的創新藥物將透過 TREMFYA 顯著改善 IBD。但我們也有目標口服勝肽,很快就會提供一些數據,我們已經提供了牛皮癬的數據。此外,我們還有古塞奇尤單抗(guselkumab)和戈利木單抗(golimumab)合併治療IBD,也是具有開創性的。

  • So very encouraged about our immunology portfolio and the ability to drive growth in the second half of the decade. More to be seen in our EBR later in the year.

    我們對我們的免疫學產品組合以及在本世紀下半年推動成長的能力感到非常鼓舞。更多內容將於今年稍後在我們的 EBR 中看到。

  • Operator

    Operator

  • Your next question is coming from Danielle Antalffy from UBS.

    您的下一個問題來自瑞銀 (UBS) 的丹妮爾·安塔菲 (Danielle Antalffy)。

  • Danielle Joy Antalffy - Analyst

    Danielle Joy Antalffy - Analyst

  • Ahmet, I wanted to actually bring you into the conversation here and ask about some of the innovation in MedTech. And specifically, you guys have an Ottava Day coming up. And just curious what you can say about, a, what we get to see? Obviously, appreciating you're not going to totally open the kimono and front-run the day. But b, and probably most importantly, sort of where you see Ottava ultimately fitting into the robotics landscape and helping contribute to a continued move higher in robotics penetration?

    艾哈邁德,我實際上想邀請您參與這裡的對話,詢問醫療技術領域的一些創新。具體來說,你們即將迎來渥太華日。只是好奇你能說些什麼,我們會看到什麼?顯然,欣賞你不會完全打開和服並在這一天搶先。但是,也許最重要的是,您認為 Ottava 最終會融入機器人領域並幫助機器人技術滲透率不斷提高嗎?

  • Ahmet Tezel

    Ahmet Tezel

  • So first of all, thank you for the question. Similar to John, this is my first call as well. So really excited to be here, equally excited to be leading a team of talented scientists, engineers and physicians as we do smarter, less invasive and more personalized solutions for our patients.

    首先,謝謝你提出這個問題。與約翰類似,這也是我的第一通電話。很高興來到這裡,同樣很高興能夠領導一支由才華橫溢的科學家、工程師和醫生組成的團隊,為我們的患者提供更聰明、侵入性更小、更個性化的解決方案。

  • So with respect to Ottava, we have made great progress on the platform. The team is really focused on combining a really differentiated architecture, based on its software and hardware, together with our best-in-class instruments. And we believe that combination of a differentiated architecture with instruments is going to enable us to have high value from day 1.

    所以就Ottava而言,我們在平台上取得了很大的進展。團隊真正專注於將基於軟體和硬體的真正差異化架構與我們一流的儀器相結合。我們相信,差異化架構與工具的結合將使我們從第一天起就獲得高價值。

  • Now we will have more updates on Ottava next month, as you mentioned. And at that time, we will provide a lot more detail. But the one point I'll make is that, even today, robotic-assisted surgery penetration is in single digits. So there's still a lot of growth left in that segment. And we're really excited because Ottava brings a lot of differentiation. So we're very excited that we can make a big kind of path. We can open our path and growth there in that segment as well.

    正如您所提到的,下個月我們將在渥太華發布更多最新消息。到時候,我們將提供更多細節。但我要指出的一點是,即使在今天,機器人輔助手術的滲透率也只有個位數。因此,該領域仍有很大的成長空間。我們真的很興奮,因為 Ottava 帶來了很多差異化。因此,我們非常高興能夠開闢一條偉大的道路。我們也可以在該領域開闢我們的道路和成長。

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • Danielle, if I may interject here on Ottava. I've been in touch with multiple surgeons around the world. And one common comment that I find is that they all want, they all are rooting for Johnson & Johnson to come into the robotic surgical space. They want to have the service and the support that they have accustomed doing decades with our Ethicon business, and they also want to be able to utilize the advanced instruments with whom they have grown. So what I see in the surgical space is that the surgeons want to have alternatives, and they are all looking forward to having Johnson & Johnson play an important role in robotic surgery.

    丹妮爾,請容許我插話渥太華。我已經與世界各地的多名外科醫生取得了聯繫。我發現的一個常見評論是,他們都希望、都支持強生進入機器人手術領域。他們希望獲得幾十年來在我們的 Ethicon 業務中所習慣的服務和支持,並且他們還希望能夠利用與他們一起成長的先進儀器。所以我在手術領域看到的是,外科醫生希望有替代方案,他們都期待強生公司在機器人手術中發揮重要作用。

  • Jessica Moore - VP of IR

    Jessica Moore - VP of IR

  • Thank you, Danielle. We have time for one last question.

    謝謝你,丹妮爾。我們還有時間回答最後一個問題。

  • Operator

    Operator

  • Our final question today is coming from Louise Chen from Cantor Fitzgerald.

    我們今天的最後一個問題來自 Cantor Fitzgerald 的 Louise Chen。

  • Louise Alesandra Chen - MD & Senior Research Analyst

    Louise Alesandra Chen - MD & Senior Research Analyst

  • I wanted to ask you on the FLAURA2 results, if they impacted at all your thinking on your market opportunity for MARIPOSA? And why or why not?

    我想問您關於 FLAURA2 結果的問題,它們是否影響了您對 MARIPOSA 市場機會的所有想法?為什麼或為什麼不呢?

  • John C. Reed - EVP of Pharmaceuticals, R&D

    John C. Reed - EVP of Pharmaceuticals, R&D

  • No, I don't think it influences because it's really important to pay attention not only to progression-free survival, but also overall survival as well as the PFS to the survival on the second line of therapy.

    不,我認為這不會產生影響,因為不僅要關注無惡化存活期,還要關注整體存活期以及二線治療存活期的 PFS,這一點非常重要。

  • Unfortunately, with today's therapies, almost all lung cancer patients will eventually relapse, they will need a second line therapy. And we think chemo was best reserved for that circumstance, where the patient now has failed the frontline targeted therapies.

    不幸的是,採用當今的治療方法,幾乎所有肺癌患者最終都會復發,他們將需要二線治療。我們認為化療最適合這種情況,因為患者現在的第一線標靶治療已經失敗。

  • So I would really say, pay attention to overall survival, pay attention to that progression-free survival, too, endpoint because these are going to be, I think, really things that matter in terms of what the long-term outcome is for patients with EGF receptor mutant lung cancer.

    所以我真的想說,要注意總生存期,也要注意無進展生存期,終點,因為我認為這些對於患者的長期結果來說確實很重要患有EGF受體突變型肺癌。

  • The -- we believe, based on the data we'll present in the Presidential session at ESMO, that the combination of RYBREVANT, our bispecific antibody, the first bispecific ever approved for a solid tumor indication, incidentally, fully human; as well as the third-generation small molecule oral EGF receptor, lazertinib, which is brain-penetrant. In our mind, we believe that, that will become the new frontline standard of care for EGF receptor mutant lung cancer and offer patients durable remissions that are achieved in a chemo-free regimen.

    - 我們相信,根據我們將在ESMO 主席會議上展示的數據,我們的雙特異性抗體RYBREVANT 的組合是第一個被批准用於實體瘤適應症的雙特異性抗體,順便說一句,是完全人源化的;以及第三代小分子口服EGF受體lazertinib,具有腦部滲透性。我們認為,這將成為 EGF 受體突變型肺癌的新第一線護理標準,並為患者提供透過非化療方案實現的持久緩解。

  • Jessica Moore - VP of IR

    Jessica Moore - VP of IR

  • Thank you, 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 you may have.

    謝謝您,也感謝大家提出的問題以及您對我們公司的持續關注。對於因時間因素無法聯繫的人士,我們深表歉意,但如果您還有任何疑問,請隨時聯繫投資者關係團隊。

  • I will now turn the call back to Joaquin for some brief closing remarks.

    現在我將把電話轉回給華金,請他發表一些簡短的結論。

  • Joaquin Duato - CEO & Chairman

    Joaquin Duato - CEO & Chairman

  • Thank you, Jess, and thank you to all of you for joining us today. I'm proud to present today the company's performance. This is the first quarter that we report as a new J&J, focused in health care innovation, in MedTech and in Pharmaceuticals. And I believe this new J&J has a better foundation to continue to drive growth for the next decades.

    謝謝你,傑西,也謝謝大家今天加入我們。我很自豪今天能夠介紹公司的業績。這是我們作為新強生公司報告的第一季度,專注於醫療保健創新、醫療技術和製藥領域。我相信這個新的強生公司擁有更好的基礎來繼續推動未來幾十年的成長。

  • We are achieving strong results in 2023 with our 7.5% adjusted operational growth in the quarter. It's the second quarter in a row that we have a beat and a raise of our guidance. And we continue to believe that we're going to have a very strong finish into 2023, and that reads well for a strong 2024, too.

    我們將在 2023 年取得強勁業績,本季調整後的營運成長為 7.5%。這是我們連續第二個季度業績好轉並提高了指導值。我們仍然相信,我們將在 2023 年取得非常強勁的成績,這也預示著 2024 年將取得強勁的成績。

  • We have a dedicated team, both in Innovative Medicines and in MedTech. And we think we are very well positioned, as I said, to carry the momentum that you are seeing in 2023 into 2024.

    我們在創新藥物和醫療技術領域擁有一支敬業的團隊。正如我所說,我們認為我們處於非常有利的位置,可以將 2023 年看到的勢頭延續到 2024 年。

  • Finally, we are looking forward to engaging all of you at our Enterprise Business Review on December 5. Thank you very much and enjoy the rest of your day.

    最後,我們期待與大家一起參加 12 月 5 日的企業業務回顧。非常感謝你們,祝你們有個愉快的一天。

  • Operator

    Operator

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

    謝謝。今天強生公司 2023 年第三季財報電話會議到此結束。您現在可以斷開連線。