Integra Lifesciences Holdings Corp (IART) 2025 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the Integra LifeSciences first-quarter 2025 financial results call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your host today, Chris Ward. Senior Director of Investor Relations. Please go ahead.

    您好,感謝您的支持。歡迎參加 Integra LifeSciences 2025 年第一季財務業績電話會議。(操作員指示)請注意,今天的會議正在錄音。現在我想將會議交給今天的主持人克里斯沃德 (Chris Ward)。投資者關係高級總監。請繼續。

  • Chris Ward - Investor Relations

    Chris Ward - Investor Relations

  • Good morning, and thank you for joining the Integra LifeSciences first-quarter 2025 earnings conference call. With me on the call are Mojdeh Poul, President and Chief Executive Officer; and Lea Knight, Chief Financial Officer. Earlier this morning, we issued a press release first quarter 2025 financial results. The release and corresponding earnings presentation, which we will reference during the call, are available at integralife.com under Investors, Events and Presentations in the file named First Quarter 2025 Earnings Call Presentation.

    早安,感謝您參加 Integra LifeSciences 2025 年第一季財報電話會議。與我一起參加電話會議的還有總裁兼執行長 Mojdeh Poul 和財務長 Lea Knight。今天早些時候,我們發布了2025年第一季財務業績新聞稿。我們將在電話會議中參考的新聞稿和相應的收益介紹可在 integralife.com 的「投資者、活動和介紹」下的名為「2025 年第一季財報電話會議介紹」的文件中查閱。

  • Before we begin, I want to remind you that many of the statements made during this call may be considered forward looking. Factors that could cause actual results to differ materially are discussed in the company's Exchange Act reports filed with the SEC and in the release. Also in our prepared remarks, we will reference reported in organic revenue growth. Organic revenue growth excludes the effects of foreign currency, acquisitions and divestitures.

    在我們開始之前,我想提醒大家,本次電話會議中的許多聲明可能被視為前瞻性的。該公司向美國證券交易委員會提交的《交易法》報告和新聞稿中討論了可能導致實際結果出現重大差異的因素。此外,在我們準備好的評論中,我們將參考報告的有機收入成長。有機收入成長不包括外幣、收購和資產剝離的影響。

  • Unless otherwise stated, all this aggregated and franchise-level revenue growth rates are based on organic performance. Lastly, include certain non-GAAP financial measures. Reconciliations of non-GAAP financial measures can be found in today's press release, which is an exhibit to Integra's current report on Form 8-K filed today with the SEC. With that, I will now turn the call over to Mojdeh.

    除非另有說明,所有這些總體和特許經營級別的收入增長率均基於有機表現。最後,包括某些非 GAAP 財務指標。非公認會計準則 (non-GAAP) 財務指標的對帳表可在今天的新聞稿中找到,該新聞稿是 Integra 今天向美國證券交易委員會 (SEC) 提交的 8-K 表格當前報告的附件。說完這些,我現在將電話轉給 Mojdeh。

  • Mojdeh Poul - President, Chief Executive Officer, Director

    Mojdeh Poul - President, Chief Executive Officer, Director

  • Good morning, everyone. Thank you for joining us on the call today. During today's call, I will provide a brief overview of our operating results for the first quarter, followed by an update on our compliance master plan new initiatives and key leadership appointments that will strengthen our auditions, overall execution and enterprise discipline. I will also provide remarks on the recent tariffs. Lea will then walk through our financial results in more detail and provide commentary on our financial look for the second quarter and full year.

    大家早安。感謝您今天參加我們的電話會議。在今天的電話會議上,我將簡要概述我們第一季的營運業績,然後介紹我們的合規總體規劃、新舉措和關鍵領導層的任命,這些將加強我們的審核、整體執行和企業紀律。我還將就最近的關稅發表評論。然後,Lea 將更詳細地介紹我們的財務業績,並對第二季和全年的財務狀況發表評論。

  • Our year has started out largely as we expected. On our first quarter performance, revenue came in at $383 million, near the top end of our guidance range. Reported revenue grew 3.7%, while organic revenue declined 3.5%, primarily due to the expected impact of ship hold. Even with those constraints, we saw positive reported revenue contribution from clearance and solid double-digit growth across many product lines not impacted by supply availability, which speaks to the strength of our underlying demand for our portfolio.

    今年的開局大致上與我們預期的一致。我們第一季的業績表現為營收 3.83 億美元,接近我們預期範圍的最高值。報告收入成長 3.7%,而有機收入下降 3.5%,主要由於船舶滯留的預期影響。即使有這些限制,我們仍然看到清倉帶來的積極收入貢獻,以及許多產品線的穩健兩位數增長,且不受供應情況的影響,這說明了我們對產品組合的潛在需求強勁。

  • Adjusted EPS for the quarter came in at $0.41, also within our guidance range. We continue to operate in healthy end markets and remain confident in the long-term growth potential of our specialized product portfolio. While we recognize we're not yet achieving the full potential of this business, our compliance master plan, along with targeted investments in our manufacturing infrastructure are positioning us for long-term sustainable growth through improved supply chain excellence.

    本季調整後的每股收益為 0.41 美元,也在我們的指導範圍內。我們繼續在健康的終端市場運營,並對我們的專業產品組合的長期成長潛力充滿信心。雖然我們認識到我們尚未充分發揮這項業務的潛力,但我們的合規總體規劃以及對製造基礎設施的有針對性的投資,使我們透過改善供應鏈卓越性實現長期可持續增長。

  • Since our fourth quarter call in February, I've had the opportunity to dig deeper and spend more time with our teams across manufacturing, quality, regulatory and commercial functions as well as our customers. I continue pressed by our team's strong commitment to our customers and our customers' consistent positive recognition of the value of our differentiated portfolio.

    自從二月召開第四季度電話會議以來,我有機會進行更深入的交流,並花更多時間與我們的製造、品質、監管和商業職能團隊以及客戶進行溝通。我繼續強調我們團隊對客戶的堅定承諾以及客戶對我們差異化產品組合價值的一貫積極認可。

  • I have also the more where organizational inefficiencies exist and where improvements are needed. As should be evident, we have embarked on a turnaround here at Integra, and I see two foundational elements in executing a successful turnaround. The first element is driving the portfolio prior position strategy that clearly defines the role and expectations of each part of our portfolio within the enterprise.

    我還了解到組織中存在哪些效率低下的地方以及哪些地方需要改進。顯而易見的是,我們已經在 Integra 開始了轉型,我認為成功轉型需要兩個基本要素。第一個要素是推動投資組合優先定位策略,明確定義企業內投資組合各部分的角色和期望。

  • This is critical as we make intentional capital allocation decisions to drive short and long-term performance by maximizing our portfolio's potential to drive growth and profitability. The second element is embedding disciplined program management and execution consistent with our enterprise priorities across operations, quality and R&D.

    這至關重要,因為我們有意做出資本配置決策,透過最大限度地發揮投資組合推動成長和獲利的潛力來推動短期和長期績效。第二個要素是嵌入與我們在營運、品質和研發方面的企業優先事項一致的規範的專案管理和執行。

  • This alignment on focused execution is the underlying intent for our newly established transformation and program management office. Our future is an organization that is disciplined and unified behind successful execution of the highest, most impactful priorities for the enterprise.

    這種對重點執行的協調是我們新成立的轉型和專案管理辦公室的根本意圖。我們的未來是一個紀律嚴明、團結一致的組織,能夠成功執行企業最高、最有影響力的優先事項。

  • We must execute and reliably serve our customers today -- we must transform our quality management system, and we must create room to selectively invest in a few impactful innovation opportunities. Going forward, these two foundational elements our portfolio rent, and program management efforts must be driven holistically and in relation to one another rather than individually.

    我們必須立即執行並可靠地為我們的客戶提供服務——我們必須轉變我們的品質管理體系,我們必須創造空間來有選擇地投資一些有影響力的創新機會。展望未來,我們的投資組合租金和專案管理工作這兩個基礎要素必須整體推動,相互關聯,而不是單獨推動。

  • We made important progress this quarter on the compliance master plan, particularly in plant level assessments and early stages of remediation. To date, from a site assessment standpoint, we've completed 10 of our manufacturing sites and remain on track to complete the remaining 4 sites by the end of third quarter.

    本季我們在合規總體規劃方面取得了重要進展,特別是在工廠級評估和補救的早期階段。到目前為止,從場地評估的角度來看,我們已經完成了 10 個製造場地,並預計在第三季末完成剩餘 4 個場地的建設。

  • We will need much of the fourth quarter to develop remaining actions from the findings and complete assessments at our key finished good suppliers. We anticipate that remediation will continue throughout 2025, and based on early findings, some remediations will continue into 2026. While there is still a significant amount of work to be done, I'm encouraged by the rigor of our process and confident in our ability to deliver sustained improvements in compliance and supply reliability.

    我們將需要第四季度的大部分時間來根據調查結果制定剩餘行動並完成對主要成品供應商的評估。我們預計修復工作將持續到 2025 年,根據早期調查結果,一些修復工作將持續到 2026 年。雖然仍有大量工作要做,但我對我們流程的嚴謹性感到鼓舞,並對我們在合規性和供應可靠性方面實現持續改進的能力充滿信心。

  • As you may recall, during the Q4 earnings call, we reported we had identified approximately $27 million in ship holds for the full year of 2025 related to the execution of the compliance master plan. We have made meaningful progress in addressing these holes and continue to expect they will be principally remediated in the second half of this year. Late in the first quarter, we identified additional ship holds for certain products within the CSS and Tissue Technologies businesses. Based on our current assessment, we now expect total ship holds for the year to be between $55 million and $70 million, which we are working diligently to resolve.

    您可能還記得,在第四季度收益電話會議上,我們報告稱,我們已經確定了與執行合規總體規劃有關的 2025 年全年約 2700 萬美元的船舶艙位。我們在解決這些漏洞方面已經取得了重大進展,並預計今年下半年這些漏洞將得到基本修復。在第一季末,我們為 CSS 和 Tissue Technologies 業務中的某些產品找到了額外的船艙。根據我們目前的評估,我們預計今年的船舶總艙等成本將在 5,500 萬美元至 7,000 萬美元之間,我們正在努力解決這個問題。

  • As we've said before, our compliance master plan is designed to address the highest risk areas of our operations and not necessarily prioritized by our highest revenue product first. Our plan is guided to address GAAP and findings related to quality system regulations, FDA warning letters and Form 483 observations. Based on the scope outline in CMP, we are on track to complete the implementation of our actions outlined in the December warning letter by year-end.

    正如我們之前所說,我們的合規總體規劃旨在解決我們營運中風險最高的領域,而不一定優先考慮我們收入最高的產品。我們的計劃旨在解決 GAAP 以及與品質系統法規、FDA 警告信和 483 表格觀察相關的發現。根據 CMP 中的範圍概述,我們預計在年底前完成 12 月警告信中概述的行動實施。

  • In connection with PMA approval, we are working diligently to resolve all warning letter of divisions to the FDA satisfaction. While our quality, resilience and capacity efforts move forward, my deep engagement across the organization has also revealed the need for more effective prioritization of our program at the enterprise level and a more disciplined approach to program management and execution.

    就 PMA 批准而言,我們正在努力解決所有部門的警告信,以使 FDA 滿意。在我們的品質、彈性和能力努力不斷向前發展的同時,我在整個組織的深入參與也表明,需要在企業層面更有效地確定我們的專案的優先順序,並採取更規範的專案管理和執行方法。

  • This need spans not only major strategic initiatives, but also the company's broader execution capability. To address this, I have established a transformation and program management office reporting directly to me. This office will lead efforts to instill a more rigorous enterprise-wide program management discipline, ensuring programs are properly prioritized scope and resource with clear milestones, KPIs and oversight to ensure timely and complete execution.

    這項需求不僅涵蓋重大策略舉措,也涵蓋公司更廣泛的執行能力。為了解決這個問題,我成立了一個直接向我報告的轉型和專案管理辦公室。該辦公室將致力於在企業範圍內建立更嚴格的專案管理紀律,確保專案得到適當的優先排序、範圍和資源分配,並設定明確的里程碑、關鍵績效指標 (KPI) 和監督機制,以確保專案及時、完整地執行。

  • Rick Maveus will be leading our enterprise Transformation and Program Management Office and brings with him strong expertise in leading complex business transformation, advancing operational excellence and driving financial performance. With over 20 years of experience, including leadership roles at 3M and most recently at Solventum, he has a proven track record in business execution planning and program management. This capability will be foundational to how we operate going forward.

    Rick Maveus 將領導我們的企業轉型和專案管理辦公室,並帶來其在領導複雜業務轉型、推進卓越營運和推動財務績效方面的豐富專業知識。他擁有超過 20 年的經驗,包括在 3M 和最近在 Solventum 擔任領導職務,在業務執行規劃和專案管理方面有著良好的記錄。這種能力將成為我們未來營運的基礎。

  • We have also further strengthened our operations and supply chain organization with the appointment of Valerie Young as Corporate Vice President, Global Operations and Supply Chain. Valerie is a seasoned executive with extensive global operations and supply chain experience across health care, automotive, industrial and consumer goods industry.

    我們也任命瓦萊麗楊 (Valerie Young) 為全球營運和供應鏈公司副總裁,進一步加強了我們的營運和供應鏈組織。Valerie 是一位經驗豐富的主管,在醫療保健、汽車、工業和消費品行業擁有豐富的全球營運和供應鏈經驗。

  • In addition to her recent work in supply chain strategy and transformation consulting, she served as Senior Vice President of Global Supply Chain Operations at 3M, where she was responsible for manufacturing and supply chain strategy and ERP deployment. I had the privilege of working closely with Valerie during my tenure at 3M, experiencing firsthand her expertise in operational strategy, Lean Six Sigma as well as driving continuous improvement in safety, quality, service, cost and working capital.

    除了最近在供應鏈策略和轉型諮詢方面的工作外,她還曾擔任 3M 公司全球供應鏈營運資深副總裁,負責製造和供應鏈策略以及 ERP 部署。在 3M 任職期間,我有幸與 Valerie 密切合作,親身體驗了她在營運策略、精益六西格瑪方面的專業知識,以及如何推動安全、品質、服務、成本和營運資金的持續改進。

  • Valerie's mandate is to strengthen the operations and supply chain leadership team and culture, while also partnering with our quality organization to ensure successful implementation of the compliance master plan. Valerie is also establishing a continuous improvement organization to drive operational excellence throughout our end-to-end supply chain network, optimizing asset management, reducing total delivery costs and most importantly, delivering quality products to our customers.

    Valerie 的職責是加強營運和供應鏈領導團隊和文化,同時與我們的品質組織合作,確保成功實施合規總體規劃。Valerie 還建立了一個持續改進組織,以推動我們端到端供應鏈網路的卓越運營,優化資產管理,降低總交付成本,最重要的是,向我們的客戶提供優質的產品。

  • As part of our investments in operational excellence, we continue to make progress on the Braintree facility which will enable us to restart production of SurgiMend and PriMatrix. Our goal is to bring the facility online in the first half of 2026. We plan to provide the project status and launch time on update for the 510(k) clear product in Q4 of this year.

    作為我們對卓越營運投資的一部分,我們繼續在布倫特里工廠取得進展,這將使我們能夠重新啟動 SurgiMend 和 PriMatrix 的生產。我們的目標是讓該設施在 2026 年上半年投入使用。我們計劃在今年第四季更新510(k)透明產品的專案狀態和發佈時間。

  • We are also making investments to enhance production capabilities for Integra Skin. As we shared on our fourth quarter call, Scheduled maintenance and equipment upgrades prevented us from fully meeting demand in Q1. However, we did deliver production and revenue performance in line with our Q1 expectations. The comprehensive set of Integra skin manufacturing resiliency program initiated last year to improve yields, upgrade equipment and optimized site utilization are beginning to pay off.

    我們也正在進行投資以提高 Integra Skin 的生產能力。正如我們在第四季度電話會議上所分享的,定期維護和設備升級使我們無法完全滿足第一季的需求。不過,我們的生產和營收表現確實符合第一季的預期。去年啟動的 Integra 表皮製造彈性計畫綜合方案旨在提高產量、升級設備和優化場地利用率,目前已開始取得成效。

  • We can see this already in Q2 and have experienced steady yield improvement for this product since Q4. We expect production and revenue run rate to return to normal this quarter and begin rebuilding safety stock in the second half of the year. Turning to our guidance. We expect second quarter revenue in the range of $390 million to $400 million, representing a reported decline of approximately minus 6.8% to minus 4.4% and includes based on the recent exchange rate movements and approximate 80 basis points tailwind versus the prior year due to foreign currency translation.

    我們在第二季度就看到了這一點,並且自第四季度以來該產品的產量一直在穩步提高。我們預計本季生產和收入運行率將恢復正常,並在下半年開始重建安全庫存。轉向我們的指導。我們預計第二季營收將在 3.9 億美元至 4 億美元之間,年減約 -6.8% 至 -4.4%,其中包括基於近期匯率變動以及由於外幣折算導致的與上年同期相比約 80 個基點的順風因素。

  • We expect organic decline in the range of minus 7.5% to minus 5.1%. As a reminder, we lapped the acquisition of Acclarent on April 1. So Acclarent revenue will be included in our organic growth metrics beginning in Q2. We are maintaining our full year revenue guidance of $1.65 billion to $1.72 billion. While the newly identified ship holds at the end of Q1 will have an impact the anticipated revenue headwinds fall within the assumptions we made when setting the guidance range.

    我們預計有機下降幅度將在-7.5%至-5.1%之間。提醒一下,我們在 4 月 1 日完成了對 Acclarent 的收購。因此,從第二季開始,Acclarent 營收將納入我們的有機成長指標。我們維持全年營收預期 16.5 億美元至 17.2 億美元不變。雖然第一季末新發現的船舶庫存將產生影響,但預期的收入阻力在我們設定指導範圍時所做的假設範圍內。

  • We expect adjusted EPS for the second quarter to be in the range of 40% to 45%. For the full year, we now expect adjusted EPS between $2.19 and $2.29. With the only adjustment to prior guidance being the impact of the recently announced global tariffs. While the tariff situation continues to rapidly evolve, we have incorporated the financial impact of the tariffs into our updated 2025 guidance based on what we know today which is obviously subject to change based on any future announcements.

    我們預計第二季調整後的每股盈餘將在 40% 至 45% 之間。我們目前預計全年調整後每股收益將在 2.19 美元至 2.29 美元之間。此前預期的唯一調整是近期宣布的全球關稅的影響。雖然關稅情況繼續快速發展,但根據我們目前所知,我們已將關稅的財務影響納入了我們更新後的 2025 年指導中,而該指導顯然可能會根據未來的任何公告而發生變化。

  • Most of our manufacturing takes place in the United States and Europe. Still, we saw certain components and finished goods from Canada, Mexico, China and other countries not subject to new tariffs. Our tariff exposure in China includes [reciprocal] tariffs from products manufactured in the US and exported into China as well as tariffs on raw materials and components important from China into the US.

    我們的大部分製造業務都在美國和歐洲進行。不過,我們發現來自加拿大、墨西哥、中國和其他國家的某些零件和成品並未受到新關稅的約束。我們在中國面臨的關稅風險包括對美國製造並出口到中國的產品徵收的[互惠]關稅,以及對從中國進口到美國的重要原料和零件徵收的關稅。

  • Our China facility currently under construction is not yet operational and is designed to serve the local Chinese market. In response to the dynamic tariff environment, we are proactively evaluating and implementing strategies to mitigate the financial impact, including optimizing sourcing, exploring pricing changes and surcharges managing landed costs and seeking potential tariff exemption. In addition, we are carefully managing our expenses to help protect profitability.

    我們目前正在建設的中國工廠尚未投入運營,旨在服務中國本土市場。為了應對動態的關稅環境,我們正在積極評估和實施減輕財務影響的策略,包括優化採購、探索價格變化和附加費、管理到岸成本以及尋求潛在的關稅豁免。此外,我們正在謹慎管理開支以幫助保護獲利能力。

  • This includes disciplined expense prioritization, closely monitoring discretionary spending and strategically allocating resources while continuing to invest in critical business initiatives. These strategies will take time to implement thoughtfully, but our focus remains on minimizing operational disruption and maintaining continuity of supply to our customers during this period of uncertainty.

    這包括嚴格確定費用優先順序、密切監控可自由支配的支出以及策略性地分配資源,同時繼續投資於關鍵業務計劃。這些策略需要時間來深思熟慮地實施,但我們的重點仍然是盡量減少營運中斷,並在這段不確定時期保持對客戶的供應連續性。

  • Lea will now provide more specifics on the first quarter financial results and share additional details on our guidance and the impact of tariffs. Lea?

    Lea 現在將提供有關第一季財務業績的更多細節,並分享有關我們的指導和關稅影響的更多細節。莉亞?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Thank you, Mojdeh. Let's take a more detailed look at our first quarter financial highlights, starting on slide 5. Total revenues for the first quarter were approximately $383 million, representing growth of 3.7% on a reported basis a decline of 3.5% on an organic basis compared to the same period last year. Reported revenues include approximately $29 million from the Acclarent acquisition and a 60 basis point FX headwind.

    謝謝你,Mojdeh。讓我們從第 5 張投影片開始更詳細地了解第一季的財務亮點。第一季總營收約 3.83 億美元,與去年同期相比,報告成長 3.7%,有機下降 3.5%。報告的收入包括來自 Acclarent 收購的約 2,900 萬美元和 60 個基點的外匯逆風。

  • Organic revenue performance was negatively impacted by several supply disruptions provided for in our guide, including ship hold amounting to approximately $18 million production timing impact to Integra Skin of about $5 million, and $4 million stemming from a private label component supply issue.

    我們的指南中提到的幾次供應中斷對有機收入表現產生了負面影響,包括船舶扣留金額約為 1800 萬美元,對 Integra Skin 的生產時間影響約為 500 萬美元,以及因自有品牌組件供應問題而產生的 400 萬美元。

  • Our adjusted EPS for the quarter was $0.41, down 25% compared to 2024. As we look down the P&L, gross margins were 62.2% for the first quarter, down 220 basis points versus 2024. Gross margins in the first quarter were negatively impacted by manufacturing variances carrying over from supply challenges in 2024, inefficiencies related to our private label supply and an increase in network optimization spend. Our adjusted EBITDA margins were 16.6%, down 290 basis points compared to 2024, reflecting the decline in gross margins and increased investment in our quality organization. Operating cash flow for the first quarter was negative $11.3 million.

    本季調整後的每股收益為 0.41 美元,較 2024 年下降 25%。從損益表中可以看出,第一季的毛利率為 62.2%,較 2024 年下降了 220 個基點。第一季的毛利率受到 2024 年供應挑戰帶來的製造差異、自有品牌供應相關的效率低下以及網路優化支出增加的負面影響。我們的調整後 EBITDA 利潤率為 16.6%,與 2024 年相比下降了 290 個基點,反映了毛利率的下降和對品質組織的投資增加。第一季經營現金流為負1130萬美元。

  • Turning to slide 6. We'll now discuss revenue highlights from our Codman Specialty Surgical segment. CSS reported first quarter revenues of $281 million, which reflects growth of 9.4% on a reported basis and a decline of 1.1% on an organic basis. Global neurosurgery revenues declined 4.7% organically, largely driven by the impact of ship holds.

    翻到幻燈片 6。我們現在將討論 Codman Specialty Surgical 部門的收入亮點。CSS 公佈第一季營收為 2.81 億美元,報告期間內成長 9.4%,有機成長率為 1.1%。全球神經外科收入有機下降 4.7%,主要受船舶滯留的影響。

  • These holds particularly affected performance across our Advanced Energy, CSF Management, dural access and repair and neuromonitoring product lines. However, demand across the neurosurgery portfolio remains strong, particularly in areas not affected by these holes. We were encouraged to see double-digit growth in key products such as DuraGen and Mayfield Capital equipments. In our E&P business, we continue to be pleased with the progress of the Acclarent integration, which contributed approximately $29 million in revenue for the quarter.

    這些暫停尤其影響了我們先進能源、腦脊髓液管理、硬腦膜通路和修復以及神經監測產品線的表現。然而,整個神經外科領域的需求依然強勁,特別是在未受這些空缺影響的領域。我們欣慰地看到 DuraGen 和 Mayfield Capital 設備等主要產品實現了兩位數的成長。在我們的 E&P 業務中,我們繼續對 Acclarent 整合的進展感到滿意,該整合為本季度貢獻了約 2,900 萬美元的收入。

  • Organic growth in our E&P reporting segment was approximately flat due to supply constraints on MicroFrance ENT. As a reminder, this organic growth reflects only the performance of the MicroFrance ENT instrument portfolio for the first 12 months following the close of the Acclarent acquisition. First quarter capital sales declined by low single digits, primarily due to a tough prior year comparison from CereLink.

    由於 MicroFrance ENT 的供應限制,我們的 E&P 報告部門的有機成長基本上持平。提醒一下,這種有機成長僅反映了 MicroFrance ENT 儀器產品組合在 Acclarent 收購結束後的前 12 個月的表現。第一季資本銷售額下降了個位數,主要原因是與 CereLink 去年同期相比較為艱難。

  • Excluding CereLink, the remainder of the capital portfolio delivered low single-digit growth. Our global capital funnel remains strong and well positioned to support future growth. We also saw a strong performance in our instruments portfolio, which delivered 15% growth driven by continued demand in both the hospital and alternate site settings as well as a favorable prior year comparable. International performance within CFS declined by high single digits with the decline primarily attributable to the timing and duration of the ship hold.

    除 CereLink 外,其餘資本組合均實現了低個位數成長。我們的全球資本管道依然強勁,並有能力支持未來的成長。我們的儀器產品組合也表現強勁,由於醫院和替代站點環境的持續需求以及去年同期的良好表現,該組合實現了 15% 的成長。CFS 的國際業績下降了個位數,主要原因是船舶停留的時間和持續時間。

  • The resolution of these holes have taken longer in the international markets than in the US limiting our ability to fulfill customer demand. Addressing these international delays is among our highest operational priorities, and we have directed significant resources to meet the continued underlying demand from our international customers.

    在國際市場上解決這些問題所花的時間比在美國更長,這限制了我們滿足客戶需求的能力。解決這些國際延誤是我們最高的營運重點之一,我們已投入大量資源來滿足國際客戶持續的潛在需求。

  • Moving to our Tissue Technologies segment on slide 7. Tissue Technologies revenues were $102 million, down approximately 9% on a reported and organic basis compared to the prior year. Sales in wound reconstruction were down due to Integra Skin and ship holds on other products, which were implemented late in the first quarter.

    前往投影片 7 上的組織技術部分。紙巾技術業務收入為 1.02 億美元,與前一年相比,報告收入和有機收入下降約 9%。由於第一季末實施的 Integra Skin 和其他產品的停運,傷口重建業務的銷售額下降。

  • We continue to see double-digit growth for DuraSorb and our UBM platform. In Private Label, sales were down 13% versus last year due to component supply delays. Finally, international sales in Tissue Technologies were down low double digits due to the forecasted production ramp-up on Integra Skin. Moving to slide 8. I will now review our balance sheet, capital structure and cash flow.

    我們繼續看到 DuraSorb 和我們的 UBM 平台實現兩位數成長。在自有品牌方面,由於零件供應延遲,銷售額較去年同期下降了 13%。最後,由於 Integra Skin 產量預計將增加,Tissue Technologies 的國際銷售額下降了兩位數。移至幻燈片 8。我現在將審查我們的資產負債表、資本結構和現金流。

  • During the first quarter, our operating cash flow was negative $11.3 million and free cash flow was negative $40.2 million, reflecting higher capital expenditures as we continue to invest in key infrastructure. As of March 31, net debt was $1.6 billion, and our consolidated total leverage ratio was 4.3 times within our current maximum allowable leverage ratio of 5 times. The current maximum allowable leverage ratio remained at 5 through the third quarter of 2025, stepping down to 4.25 for Q4 of 2025. We ended the first quarter with total liquidity of $1.2 billion, including $273 million in cash and short-term investments, with the remaining liquidity available under our revolving credit facility.

    第一季度,我們的營運現金流為負 1,130 萬美元,自由現金流為負 4,020 萬美元,這反映出我們繼續投資於關鍵基礎設施,導致資本支出增加。截至 3 月 31 日,淨負債為 16 億美元,我們的合併總槓桿率為 4.3 倍,而我們目前的最大允許槓桿率為 5 倍。目前允許的最大槓桿率在 2025 年第三季仍維持在 5,到 2025 年第四季將降至 4.25。截至第一季末,我們的總流動資金為 12 億美元,其中包括 2.73 億美元的現金和短期投資,其餘流動資金可透過循環信貸安排獲得。

  • If you turn to slide 9, I will provide our consolidated revenue and adjusted earnings per share guidance for the second quarter and full year 2025. Before doing so, I'd like to take a moment to provide some background on the recently announced tariffs and how we're approaching them in our outlook. Although there is still uncertainty surrounding the administration's ongoing global trade negotiations, we have included the impact of the new tariffs in our second quarter and full year guidance.

    如果您翻到第 9 張投影片,我將提供 2025 年第二季和全年的綜合收入和調整後每股盈餘指引。在此之前,我想花點時間介紹一下最近宣布的關稅背景以及我們在展望中如何處理這些關稅。儘管圍繞政府正在進行的全球貿易談判仍然存在不確定性,但我們已將新關稅的影響納入第二季和全年指引中。

  • We also believe it's helpful to quantify the specific effects and highlight the key drivers of the tariffs in our guides. To provide context, we operate a global manufacturing network consisting of 14 facilities. The majority of our manufacturing occurs in the United States and Europe with key international sites in Ireland, Switzerland, France and Israel.

    我們也認為,量化具體影響並在指南中強調關稅的關鍵驅動因素是有幫助的。為了提供背景信息,我們運營著一個由 14 個工廠組成的全球製造網絡。我們的製造業務大多在美國和歐洲進行,主要國際工廠位於愛爾蘭、瑞士、法國和以色列。

  • We also contract a portion of manufacturing in Germany, Costa Rica, Japan, Mexico and Canada. Approximately half of our global revenue is generated from products manufactured in the United States. In China, which accounts for approximately 5% of our total revenue, roughly half of the products we sell are manufactured in the United States. While we are building a China-based manufacturing facility to support long-term growth in the region, it is not expected to be operational in 2025.

    我們也在德國、哥斯大黎加、日本、墨西哥和加拿大承包了部分製造業務。我們全球約一半的收入來自美國製造的產品。中國約占我們總收入的 5%,我們銷售的產品中約有一半是在美國製造的。雖然我們正在中國建造製造工廠以支持該地區的長期成長,但預計它不會在 2025 年投入運作。

  • We estimate an impact of approximately $22 million in 2025 or $0.22 per share on an after-tax basis. This estimate assumes the application of the global 10% tariff on goods entering the United States with rates increasing to various country-specific rates following the 90-day pause on July 9. The estimate also includes the new China specific tariff of 125% on US exports to China and 145% from Chinese exports to the United States.

    我們估計 2025 年的影響約為 2,200 萬美元,或稅後每股 0.22 美元。這項估計假設對進入美國的商品徵收全球 10% 的關稅,並且在 7 月 9 日 90 天的暫停期後,稅率將提高到各國特定的稅率。該估算還包括對美國出口到中國的商品徵收 125% 的特定關稅,以及對中國出口到美國的商品徵收 145% 的特定關稅。

  • Our teams are focused on developing and implementing mitigation solutions that are both timely and sustainable. Tariff costs will be accounted for within our cost of goods sold and will be capitalized in inventory and recognize as those products are sold. Inventory associated with products manufactured outside the US and imported into the US turnover in approximately four to seven months. Finished goods imported into China from the US turnover in approximately one month.

    我們的團隊致力於開發和實施及時且可持續的緩解解決方案。關稅成本將計入我們的銷售成本中,並將在庫存中資本化,並在這些產品售出時確認。與美國境外生產並進口到美國的產品相關的庫存週轉期約為四到七個月。從美國進口到中國的成品週轉時間約為一個月。

  • We expect a progressive impact to our gross margin and adjusted EPS across the final three quarters of 2025 with an adjusted EPS impact in the second quarter of approximately $0.04. Turning to our guidance for the second quarter of 2025. We expect revenues to be in the range of $390 million to $400 million, representing a reported decline between minus 6.8% and minus 4.4% and based on recent exchange rate movements, includes an estimated 80 basis point tailwind versus the prior year from foreign currency translation.

    我們預計,這將對2025年最後三個季度的毛利率和調整後每股盈餘產生漸進性影響,第二季調整後每股盈餘的影響約為0.04美元。以下是我們對2025年第二季的業績預期。我們預計收入將在 3.9 億美元至 4 億美元之間,代表報告的下降幅度在-6.8% 至-4.4% 之間,並且根據最近的匯率變動,包括與上一年相比因外幣折算而預計的 80 個基點的順風。

  • We expect an organic decline between minus 7.5% and minus 5.1%. Our forecast reflects continued strong global demand for our products, normal seasonal sequential improvement and the benefit of improved production yields for Integra Skin. These gains will be more than offset by approximately $25 million in expected revenue impact from ship holds in the quarter related to execution of the compliance master plan.

    我們預計有機下降幅度將在-7.5%至-5.1%之間。我們的預測反映了全球對我們產品的持續強勁需求、正常的季節性連續改善以及 Integra Skin 生產產量提高的好處。這些收益將被本季與執行合規總體規劃相關的船舶停泊預計產生的約 2,500 萬美元收入影響所抵銷。

  • For the full year, we are reaffirming our revenue guidance in the range of $1.65 billion to $1.72 billion. This forecast reflects sustained demand for our portfolio and remains consistent with our original guidance assumptions around the potential impact of ship hold. To date, cumulative full year revenue impact of identified ship holds is approximately $55 million to $70 million.

    對於全年,我們重申營收預期在 16.5 億美元至 17.2 億美元之間。這項預測反映了對我們產品組合的持續需求,並與我們最初關於船舶艙位潛在影響的指導假設一致。迄今為止,已確定的船艙對全年收入的累積影響約為 5,500 萬至 7,000 萬美元。

  • As a reminder, our full year guidance range contemplated between $90 million and $150 million of ship holds associated with the compliance master plan. Our updated guidance also reflects an approximate $10 million benefit from FX since our February earnings call. Based on our guidance range, we expect full year reported revenue growth of 2.4% to 6.5% and organic growth of approximately 0.4% to 4.4%.

    提醒一下,我們的全年指導範圍預計與合規總體規劃相關的船舶貨艙價值在 9,000 萬美元至 1.5 億美元之間。我們更新後的指引也反映出自二月收益電話會議以來外匯業務帶來的約 1,000 萬美元收益。根據我們的指導範圍,我們預計全年報告收入將增長 2.4% 至 6.5%,有機增長約為 0.4% 至 4.4%。

  • Our 2025 revenue forecast assumes four primary drivers of sequential improvement throughout the year. First, we expect to benefit from typical seasonal volume increases. Second, we expect a moderating impact from the currently known ships later in the year. Third, we anticipate a step-up in Integra Skin sales as production continues to ramp. Finally, we project stronger private label sales in the second half of the year.

    我們對 2025 年收入的預測假設全年收入連續改善的四個主要驅動因素。首先,我們預計將受益於典型的季節性銷售成長。其次,我們預計今年稍後目前已知的船隻的影響將會減緩。第三,隨著產量不斷增加,我們預計 Integra Skin 的銷售量將會上升。最後,我們預期下半年自有品牌銷售將會更加強勁。

  • Turning to adjusted earnings per share. For the second quarter, we expect EPS to be in the range of $0.40 to $0.45, reflecting the effects of the ship hold, increased investments tied to compliance initiatives and the tariff impact. For the full year 2025, we expect adjusted earnings per share in the range of $2.19 to $2.29. This outlook reflects the underlying revenue growth of the business, compliance investments and manufacturing variances and our commitment to careful cost management to preserve key strategic priorities while maintaining profitability.

    轉向調整後每股收益。對於第二季度,我們預計每股收益將在 0.40 美元至 0.45 美元之間,這反映了船舶滯留、與合規舉措相關的投資增加以及關稅影響的影響。我們預計2025年全年調整後每股盈餘將在2.19美元至2.29美元之間。這一預期反映了公司業務的潛在收入成長、合規投資和製造差異,以及我們致力於謹慎的成本管理,以在保持獲利能力的同時,確保關鍵策略重點的實現。

  • The only change to the full year EPS outlook from prior guidance is to account for the impact of the recently announced tariffs, which we estimate may be up to $0.22 per share. For your reference, slide 10 outlines the key assumptions supporting both our second quarter and full year guidance, along with relevant modeling inputs and initial assumptions regarding tariff-related impacts in our guidance.

    與先前的指引相比,全年每股收益預期唯一的變化是考慮到最近宣布的關稅的影響,我們估計關稅可能高達每股 0.22 美元。供您參考,投影片 10 概述了支持我們第二季度和全年指引的關鍵假設,以及相關模型輸入和有關我們指引中與關稅相關的影響的初步假設。

  • Before we move to Q&A, we want to take a moment to thank all of our employees for their hard work and the progress we continue to make together. Your dedication and perseverance are critical to driving our momentum and strengthening our foundation for the future. We would also like to thank our investors for joining us today and for your continued support and partnership.

    在進入問答環節之前,我們想花點時間感謝所有員工的辛勤工作以及我們共同的進步。您的奉獻和毅力對於推動我們的發展勢頭和鞏固我們未來的基礎至關重要。我們也要感謝我們的投資者今天的加入以及你們一直以來的支持和合作。

  • With that, we'll now open the line for questions. Operator, please open the line.

    現在,我們將開放問答熱線。接線員,請接通線路。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Matt Taylor, Jefferies.

    馬特泰勒,傑富瑞。

  • Unidentified Participant

    Unidentified Participant

  • All right. Great. Thanks for taking our questions. This is actually [Yao Ling] in for Matt. I guess to start, maybe just on the 2Q guidance, a little bit more than expected, but some of that is related to the shipping delays. I wanted to hear a little bit more about what you found sort of late in 1Q for you to up that number even though it's within the annual guidance. And then just the assumptions on the end of 2Q guidance? And then just the confidence level for the second half of the year, given that it will be a bigger ramp.

    好的。偉大的。感謝您回答我們的問題。這實際上是 [姚玲] 取代馬特。我想首先,也許只是第二季的指導,比預期多一點,但其中一些與運輸延遲有關。我想多聽聽您在第一季末發現的情況,儘管該數字在年度指導範圍內,但您還是提高了該數字。那麼,第二季末的指引有何假設?然後是下半年的信心水平,因為這將是一次更大的增長。

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Certainly. Thank you for the question. So to your point, on Q2, it does reflect the newly -- the impact of the newly identified ship holds which did bring down kind of our original expectation of Q2. That said, we did as part of our February call and the full year guidance, we did contemplate the risk of finding additional ship holds during the course of the year, right?

    當然。謝謝你的提問。所以就您的觀點而言,第二季確實反映了新發現的船舶滯留的影響,這確實降低了我們對第二季的最初預期。也就是說,作為二月份電話會議和全年指導的一部分,我們確實考慮過在一年內找到額外船艙的風險,對嗎?

  • And that was part of the work we were doing as part of the compliance master plan. So we saw that play out in Q2. It's reflected in the guide that you heard for Q2 at the midpoint, the Q2 guide now reflects a step-up of about $12 million versus Q1. That reflects improved Integra production.

    這是我們作為合規總體規劃的一部分所進行的工作。我們在第二季度看到了這一情況。這反映在您聽到的第二季中期指南中,第二季指南現在反映出與第一季相比增加了約 1200 萬美元。這反映了 Integra 產量的提高。

  • So we'll see that step up in Q2 versus Q1. It does reflect a little bit of normal seasonality that we see in Q2 versus Q1 of about $10 million. And then it is offset by kind of the net incremental shipping holds that I discussed. As it relates to the balance of the year because I believe your second half of your question was with respect to the second half lift.

    因此,我們會看到第二季相對於第一季有所提升。它確實反映了我們在第二季度看到的一些正常的季節性變化,與第一季相比約為 1000 萬美元。然後它被我討論過的淨增量運輸量所抵消。因為它與今年的餘額有關,因為我相信你問題的後半部分是關於下半年的提升。

  • From a second half perspective, again, at the midpoint, our guide reflects a step-up of about $125 million second half versus first half. And drivers of that are about 30% due to the combination of Integra skin production continued to improve throughout the balance of the year, along with the resolution of our private label supply constraints. So we'll see a step up in that part of the business as well.

    從下半年的角度來看,同樣,在中點,我們的指南反映出下半年與上半年相比增加了約 1.25 億美元。其中約 30% 的驅動因素是由於 Integra 皮膚產量在全年持續改善,以及我們自有品牌供應限制的解決。因此,我們也將看到該部分業務的進步。

  • Another 30% of that has to do with stronger demand that we're seeing from parts of our portfolio that have not been impacted by supply. We'd be about 15% of that lift driven by a net supply improvement. So while we did see supply or ship holds in Q1 and Q2, they'll start to abate a bit in the second half, so we'll see improvement there. And the final 25% driven by our seasonal demand.

    另外 30% 與我們投資組合中未受到供應影響的部分產品的需求強勁有關。其中約 15% 的增幅是由淨供應改善所推動的。因此,雖然我們在第一季和第二季確實看到了供應或船舶滯留的情況,但下半年這種現象將開始減弱,因此我們會看到情況有所改善。最後的 25% 則由季節性需求驅動。

  • Unidentified Participant

    Unidentified Participant

  • Great. Very helpful. And then, I guess, to follow up on second question on tariff impact. And you called out $22 million, $0.22 impact for '25 and kind of wondering how much mitigation efforts are built into that? And then how should we view that number for 2026. Should we annualize it? Will there be (inaudible)

    偉大的。非常有幫助。然後,我想,我們來回答關於關稅影響的第二個問題。您預計 25 年的損失為 2,200 萬美元,影響為 0.22 美元,您想知道其中有多少緩解措施?那我們該如何看待2026年的這個數字呢?我們應該將其年度化嗎?會有(聽不清楚)

  • Mojdeh Poul - President, Chief Executive Officer, Director

    Mojdeh Poul - President, Chief Executive Officer, Director

  • Thank you for your question. So we have several mitigations that we're pursuing when it comes to tariffs. In the near term, obviously, we're continuing to apply for tariff exemptions and we're considering pricing -- selected pricing increases as well as surcharges where appropriate and possible.

    感謝您的提問。因此,在關稅問題上,我們正​​在採取幾項緩解措施。顯然,短期內我們將繼續申請關稅豁免,我們正在考慮定價——在適當和可能的情況下選擇提高價格以及徵收附加費。

  • And then when it comes to longer-term actions, it's about sourcing optimization and also optimizing our supply chain network and value streams and obviously, we do have the manufacturing facility in China that we're building. We are actively pursuing all these mitigations, both short and long term, but we haven't built the impacts of them into our guide at this point. Lea, if you want to?

    然後,當涉及長期行動時,它是關於採購優化以及優化我們的供應鏈網路和價值流,顯然,我們確實在中國建造了製造工廠。我們正在積極尋求所有這些緩解措施,包括短期和長期的,但目前我們還沒有將它們的影響納入我們的指南中。莉亞,你願意嗎?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Yeah. Let me take the second part of the question. So to your point, the $22 million that we characterized is specific to 2025. At this point, we think it's a little premature to provide guidance specific to 2026, we'll need to wait to understand more about how the tariff policy is finalized in the coming weeks and months.

    是的。我來回答問題的第二部分。所以正如您所說,我們所說的 2200 萬美元是針對 2025 年的。目前,我們認為提供針對 2026 年的具體指導還為時過早,我們需要等待以了解更多有關未來幾週和幾個月內關稅政策如何最終確定的資訊。

  • Unidentified Participant

    Unidentified Participant

  • Great. Thank you very much.

    偉大的。非常感謝。

  • Operator

    Operator

  • Ryan Zimmerman, BTIG.

    Ryan Zimmerman,BTIG。

  • Unidentified Participant

    Unidentified Participant

  • Hi, everyone. This is Izzy on for Ryan. Thanks for taking the question. I heard your commentary on the expectation for private label to step up in the back half of the year. But I was just curious what kind of line of sight you have into demand and what is contributing to your confidence there.

    大家好。這是 Izzy 為 Ryan 表演的。感謝您回答這個問題。我聽到了您對自有品牌在下半年有望崛起的評論。但我只是好奇您對需求有什麼樣的看法,以及是什麼增強了您的信心。

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Thank you for the question. Yes, we do anticipate a second half step up. The order of magnitude is about a $10 million step up second half versus first half. On a full year basis, we are adjusting our private label forecast down a bit. So we are now calling it to be about a low single-digit decline. Previously, we thought it'd get back to flat. That said, we still believe that this business is forward into 2026, it will continue to perform at a mid-single-digit growth trajectory.

    謝謝你的提問。是的,我們確實預計下半年會有所進步。與上半年相比,下半年的數量級增加了約 1,000 萬美元。從全年來看,我們稍微下調了自有品牌的預測。因此我們現在稱之為低個位數下降。此前,我們以為它會恢復平穩。儘管如此,我們仍然相信這項業務在 2026 年將繼續保持中等個位數的成長軌跡。

  • Unidentified Participant

    Unidentified Participant

  • Thank you, that's helpful. And then instruments had pretty strong growth this quarter with the double digits. We were curious if there was any pull forward in demand that -- in that line from tariffs.

    謝謝,這很有幫助。本季度,儀器銷量實現了兩位數的強勁成長。我們很好奇,關稅是否會對需求產生任何拉動動作用。

  • Mojdeh Poul - President, Chief Executive Officer, Director

    Mojdeh Poul - President, Chief Executive Officer, Director

  • So not -- so in general, our instrument business tends to be lumpy. So we do have quarter-to-quarter and we'll see variations in terms of growth and performance, not necessarily driven by tariffs per se. On a full year basis, we would expect that business to continue to be kind of the low, mid-single-digit growth trajectory that we typically see on that business.

    所以,總的來說,我們的儀器業務往往不太穩定。因此,我們確實存在季度間差異,我們會看到成長和業績方面的變化,而這不一定是由關稅本身驅動的。從全年來看,我們預計該業務將繼續保持我們通常在該業務上看到的低、中個位數成長軌跡。

  • Unidentified Participant

    Unidentified Participant

  • Great. Thanks for taking the questions.

    偉大的。感謝您回答這些問題。

  • Operator

    Operator

  • Vik Chopra, Wells Fargo.

    喬普拉(Vik Chopra),富國銀行。

  • Vik Chopra - Analyst

    Vik Chopra - Analyst

  • Hey, good morning, and thanks for taking my question. Mojdeh, you've been there for, I guess, about a quarter. And I'd just love to hear kind of what has surprised you to the upside to the downside? And then I had a quick follow-up question, please.

    嘿,早上好,感謝您回答我的問題。Mojdeh,我猜你已經在那裡待了大約四分之一了。我很想聽聽哪些事情讓您感到驚訝,無論是好的方面還是壞的方面?然後我有一個快速的後續問題,請問。

  • Mojdeh Poul - President, Chief Executive Officer, Director

    Mojdeh Poul - President, Chief Executive Officer, Director

  • Yeah. Hi, Vik, it's good to hear your voice. Yes, I'd like to answer that question in the context of the what and the how. What in the sense of, did I know everything that was going on here regarding the supply chain challenges and quality work that's being done. So the answer to what was the part of the challenges that we were facing.

    是的。你好,維克,很高興聽到你的聲音。是的,我想從什麼和如何的角度來回答這個問題。從什麼意義上說,我是否了解這裡發生的有關供應鏈挑戰和正在進行的品質工作的一切。那麼答案就是我們面臨的挑戰是什麼。

  • Yes, that was not a surprise to me. The Board had been very transparent with me about that. I think my finding during the time that I have been here is more around how we operate and move forward our priorities. So to me, that's about execution. I think that's where I see the opportunities for significant improvement.

    是的,這對我來說並不令人意外。董事會對此事向我非常坦誠。我認為我在這裡任職期間的發現更多地與我們如何運作和推進我們的優先事項有關。所以對我來說,這就是執行的問題。我認為這就是我看到的重大改進機會。

  • And that's why I have actually established the Office of Transformation program management because what I'm trying to drive is to have prioritization of our key initiatives and programs at the enterprise level so the organization has clarity around what's the most important for us to drive short- and long-term performance for the company.

    這就是我設立轉型專案管理辦公室的原因,因為我想要推動的是在企業層面對我們的關鍵舉措和專案進行優先排序,以便組織能夠清楚地了解對於我們推動公司短期和長期業績而言最重要的事情。

  • And then how do we scope those programs? How do we resource them adequately and how do we put in place the governance that's required to make sure we manage them to the key milestones and deliverables that they have to deliver in order to execute those programs and initiatives on time and in full. So for us, it's about advancing the foundational capabilities that are required to make performance and operational excellence part of the fabric of what we do and how we do things at Integra.

    那我們要如何確定這些計劃的範圍呢?我們如何為他們提供充足的資源,以及如何實施必要的治理,以確保我們管理他們實現他們必須交付的關鍵里程碑和可交付成果,以便按時、全面地執行這些計劃和舉措。因此,對我們來說,這是為了提升所需的基礎能力,使績效和卓越營運成為我們在 Integra 所做工作和做事方式的一部分。

  • Vik Chopra - Analyst

    Vik Chopra - Analyst

  • Got it. Thank you. That's very insightful. My follow-up question is for Lea. I have a convert maturing in August of this year. Any thoughts on how you plan to satisfy that commitment? Thanks for taking the questions.

    知道了。謝謝。這很有見地。我的後續問題是針對 Lea 的。我有一個皈依者,今年八月就成熟了。您計劃如何履行這項承諾?感謝您回答這些問題。

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Thanks, Vik. I appreciate the question. Yeah. So the convert that is maturing in August, we intend to satisfy that maturity on our revolver. We do also have a swap portfolio that comes online around that time as well. That portfolio will allow us to fix about over half of our debt outstanding at that time with an interest rate that will be in the low 3% range. So that's how we'll manage that, and we'll have that position through the end of 2027. And we'll then look to determine a more permanent financing structure in 2026.

    謝謝,維克。我很感謝你提出這個問題。是的。因此,對於 8 月到期的轉換,我們打算透過我們的循環信貸來滿足這項到期要求。我們確實也有一個掉期投資組合,也是在那個時候上線的。該投資組合將使我們能夠以 3% 以下的利率償還當時未償還債務的一半以上。這就是我們的管理方式,我們將保持這一地位直到 2027 年底。然後,我們將在 2026 年確定更永久的融資結構。

  • Operator

    Operator

  • Robbie Marcus, JPMorgan.

    摩根大通的羅比·馬庫斯。

  • Unidentified Participant

    Unidentified Participant

  • Hi. This is actually Lilly on for Robbie. Thanks for taking the question. One follow-up on tariffs. I was wondering if you could break down the different components of the tariff impact and what's assumed in the guide? How much of that $22 million is from your exposure to China? And how much of it is from Europe and other international imports?

    你好。這實際上是 Lilly 為 Robbie 所做的。感謝您回答這個問題。關於關稅的後續問題。我想知道您是否可以分解關稅影響的不同組成部分以及指南中的假設是什麼?這 2,200 萬美元中有多少來自您在中國的投資?其中有多少來自歐洲和其他國際進口?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Yes. So let me answer that by giving you kind of a sense of how we -- how tariffs are showing up in the P&L. And I think that will give you a sort of kind of relative side thing. So first, -- the costs associated with products manufactured outside the US and import it into the US, we capitalize that into inventory, and we recognize that cost through the P&L and cost of goods sold, typically over a four- to seven-month kind of horizon.

    是的。因此,讓我透過讓您了解關稅在損益表中是如何體現的來回答這個問題。我認為這會給你提供一種相對的東西。首先,我們將在美國境外生產並進口到美國的產品的相關成本資本化為庫存,並透過損益表和銷售成本確認該成本,通常是在四到七個月的時間範圍內。

  • Second, the tariffs on goods imported into China from the US, we recognize also through cost of goods sold as those products are sold, and that's typically with a one-month horizon. So as you'll see, the cost associated with goods exported to China will be realized on a much more immediate basis.

    其次,對於從美國進口到中國的商品的關稅,我們也透過銷售這些產品時的銷售成本來確認,這通常以一個月為一個週期。因此,正如您所看到的,出口到中國的商品的相關成本將會更直接地反映出來。

  • In Q2, we're seeing about a $0.04 impact, which is largely China. As we progress throughout the balance of the year, you'll see more of that start costs start to be reflected from the goods that we import into the US. But in the immediate, it will be more so China-based.

    在第二季度,我們看到的影響約為 0.04 美元,主要來自中國。隨著我們全年餘額的不斷增加,您會看到更多的起始成本開始反映在我們進口到美國的商品上。但就目前而言,它將更多地以中國為基礎。

  • Unidentified Participant

    Unidentified Participant

  • Got it. And just as a follow-up on the guide, the $55 million to $70 million in ship holds is a pretty big step up from the $27 million previously. So I'm just trying to get a sense for how conservative you feel this guide is how derisked do you think this updated outlook is? And what gives you the confidence in the ramp over the rest of the year? Thanks so much.

    知道了。作為指南的後續內容,5500 萬美元至 7000 萬美元的船艙空間比之前的 2700 萬美元有了相當大的提升。所以我只是想了解您認為這份指南有多保守,您認為更新後的展望有多低風險?那麼,是什麼讓您對今年剩餘時間的成長充滿信心呢?非常感謝。

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • No worries. So to your point, our guide that we communicated back in February did allow us was constructed with the intent to allow us to absorb about $90 million to $150 million in supply disruptions. Based on that and where we currently are, we could absorb an incremental $20 million in supply disruptions for the balance of the year and still hit the high end of our guide.

    不用擔心。所以正如您所說,我們在二月份傳達的指南確實允許我們吸收約 9,000 萬至 1.5 億美元的供應中斷。基於此以及我們目前的狀況,我們可以在今年餘下的時間裡吸收增量的 2000 萬美元的供應中斷,並且仍然達到我們指導的高端。

  • So the high end remains possible from a -- as we look across the other parts of the business, we're also seeing strong momentum from an Integra Skin production perspective. Our expectations on how private label supply constraints will be alleviated along with strength and demand that we're seeing from other parts of our portfolio that aren't impacted by supply that momentum also gives us confidence that the high end of our range is still possible. So in short, just felt it was too premature at this point to bring down the high end of the guide.

    因此,從業務的其他部分來看,高端產品仍然是可能的,我們也從 Integra Skin 的生產角度看到了強勁的發展勢頭。我們對自有品牌供應限制將如何得到緩解的預期,以及我們從不受供應影響的其他產品組合中看到的強勁需求,這種勢頭也讓我們有信心,我們的高端產品系列仍然是可能的。簡而言之,我覺得現在降低指南的高端還為時過早。

  • Unidentified Participant

    Unidentified Participant

  • Great. Thank you.

    偉大的。謝謝。

  • Operator

    Operator

  • Richard Newitter, Truist.

    Richard Newitter,Truist。

  • Unidentified Participant

    Unidentified Participant

  • Hi, good morning. This is Ravi for Rich. Thank you for taking the question. I guess my first question is around some of the remediation commentary that you're talking about sounds like Mongo, put in some of the personnel that are needed to kind of take this to the finish line. But regarding the 2026 commentary around that -- can -- is there a goal or is there any color that you can give around remediation being completed by the time Braintree goes live? Like can we -- I guess what I'm trying to ask is, can we have a clearing event by that time potentially? And then I have a follow-up.

    嗨,早安。我是 Rich 的 Ravi。感謝您回答這個問題。我想我的第一個問題是關於您所談論的一些補救措施的評論,聽起來像 Mongo,投入一些需要的人員來完成這件事。但關於 2026 年的評論 —— 有沒有一個目標,或者您能否透露一下 Braintree 上線時補救措施是否已經完成?例如我們可以嗎——我想我要問的是,到那時我們有可能舉行一次清算活動嗎?然後我有一個後續問題。

  • Mojdeh Poul - President, Chief Executive Officer, Director

    Mojdeh Poul - President, Chief Executive Officer, Director

  • Yeah. Thank you for your question. So a couple of parts to your question. Regarding our efforts on compliance master plan and remediations. We, as stated, we have completed the assessments in 10 of our 14 manufacturing sites and the remaining 4 are going to be completed by the end of the third quarter. And then in the fourth quarter is where we'll be evaluating the findings as well as strategizing with the remediation plans.

    是的。感謝您的提問。您的問題有幾個部分。關於我們在合規總體規劃和補救措施方面的努力。正如我們所說,我們已經在 14 個製造基地中的 10 個完成了評估,其餘 4 個將在第三季末完成。然後在第四季度,我們將評估調查結果並制定補救計劃。

  • And then also in Q4, we are doing the assessments in our key finished goods suppliers. And so all the assessments are going to be completed by the end of the year. And most of the remediations we plan on completing by year-end, a few of them that may require process remediations may take into 2026. But that's more broadly around the remediation planning.

    同樣在第四季度,我們正在對主要成品供應商進行評估。所有評估都將在年底前完成。我們計劃在年底前完成大部分補救措施,其中一些可能需要流程補救的措施可能會持續到 2026 年。但這更廣泛地涉及補救計劃。

  • Now when it comes to the warning letter and the resolution of the warning letter, we are working very diligently to do our part in making sure that we complete our implementation actions in time for the FDA. And we are already working towards making sure that by the time that the manufacturing site is up and running in Braintree that we will have resolved the FDA warning letters.

    現在談到警告信和警告信的解決方案,我們正在非常努力地盡自己的一份力量,確保我們及時為 FDA 完成實施行動。我們正在努力確保在布倫特里生產基地投入運作時能夠解決 FDA 的警告信。

  • However, there's only a certain part of it that's in our control, which is us doing our part with delivering to the key action items that we have provided to FDA that's outlined in the warning letter and we are running on track with those. And we have been in regular dialogue with the FDA.

    然而,我們只能控制其中的一部分,也就是我們盡自己的努力向 FDA 提供警告信中概述的關鍵行動項目,而我們正在按照這些項目進行。我們一直與 FDA 保持定期對話。

  • We have submitted one update to them in actually in March, and there's another update that we're providing to them on our progress in the middle of May. So we've been with dialogue with them working diligently to address all the findings.

    實際上,我們在三月就已經向他們提交了一份更新報告,我們將在五月中旬向他們提供另一份有關我們進展的更新報告。因此,我們一直在與他們進行對話,努力解決所有發現的問題。

  • Unidentified Participant

    Unidentified Participant

  • Great. Thank you. That was super helpful commentary. And then I guess my second one is on skin substitutes and LCD pushouts, I guess, that were supposed to go into effect about a month ago, but not anymore. So can you maybe talk about what you're seeing in that space, maybe what the overall kind of view of the industry looks like right now and what you may be doing to get some more of your products on that list if you think that it's going to be coming back into effect potentially next year or later on in the future? Thank you.

    偉大的。謝謝。這是非常有用的評論。然後我想我的第二個是關於皮膚替代品和 LCD 推出的,我想,這些應該在大約一個月前生效,但現在不再生效了。那麼,您能否談談您在該領域看到的情況,也許目前整個行業的情況如何,以及如果您認為該法案可能會在明年或將來晚些時候重新生效,您可能會採取哪些措施讓更多產品列入該名單?謝謝。

  • Mojdeh Poul - President, Chief Executive Officer, Director

    Mojdeh Poul - President, Chief Executive Officer, Director

  • Sure. Thank you for your question. We -- just a reminder that majority of our business is on the -- in the inpatient and not outpatient, even though we have products that are on the list. But majority of our revenue is inpatient. However, we definitely think this is a positive that the products with the proven clinical evidence would be called out for being the products that get used. We think that's a great move, and we look forward to the implementation of it in January, hopefully.

    當然。感謝您的提問。我們——只是提醒一下,我們的大部分業務是在住院病人而不是門診病人,儘管我們有清單上的產品。但我們大部分的收入來自住院治療。然而,我們確實認為這是一件好事,具有經過驗證的臨床證據的產品將被稱為可以使用的產品。我們認為這是一個偉大的舉措,我們希望它能在一月實施。

  • Operator

    Operator

  • Joanne Wuensch, Citi.

    花旗銀行的 Joanne Wuensch。

  • Unidentified Participant

    Unidentified Participant

  • Hi, everyone. This is Anthony on for Joanne. Just one from us. With the tariff mitigation strategies, particularly the more disciplined expense management, how confident are you that this isn't going to impact any of your remediation efforts and the ability to get branch up by next year? Thanks.

    大家好。這是喬安妮的安東尼。我們只有一個。透過關稅減免策略,特別是更嚴格的費用管理,您是否有信心這不會影響您的任何補救措施和明年開展分支機構的能力?謝謝。

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Yeah, Anthony, thanks for the question. So to your point, again, we are in the process of implementing those tariffs mitigation actions. And given kind of the nature and materiality of it, there definitely is a high priority for us. At this point, we don't believe it will get in the way of our ability to do that as well as continue our progress on the CMP or those remediation efforts.

    是的,安東尼,謝謝你的提問。所以正如您所說,我們正在實施這些關稅減免措施。鑑於其性質和重要性,我們絕對將其放在優先地位。目前,我們認為這不會妨礙我們實現這一目標的能力,也不會妨礙我們繼續推進 CMP 或補救工作。

  • Again, as a reminder, our tariff mitigation actions are around pricing, sourcing, logistics, some local in China for China production ultimately. So we see those as initiatives or measures that we can take an incremental two CMP measures without conflict.

    再次提醒,我們的關稅減免行動最終是圍繞著定價、採購、物流以及中國本地生產。因此,我們將這些視為舉措或措施,我們可以採取漸進式兩項 CMP 措施而不會發生衝突。

  • Operator

    Operator

  • Jayson Bedford, Raymond James.

    傑森貝德福德、雷蒙詹姆斯。

  • Jayson Bedford - Analyst

    Jayson Bedford - Analyst

  • Good morning. Just a couple of questions that probably require quick answers. I think they're all for Lea. First, on the $22 million in tariffs, is it fair to say that half of the impact is China, if I just carry the $0.04 through the year.

    早安.僅有幾個問題可能需要快速回答。我認為他們都是為了 Lea。首先,關於 2,200 萬美元的關稅,如果我只將 0.04 美元計入全年,是否可以說其中一半的影響來自中國?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • For 2025, directionally, that's close. That's about right, yeah.

    對於 2025 年來說,從方向來看,已經很接近了。是的,差不多是這樣。

  • Jayson Bedford - Analyst

    Jayson Bedford - Analyst

  • Okay. And then on the guide for the year, the revenue guide, I think you mentioned a change in expectations for private label. Any other notable segment changes embedded in the '25 revenue guide?

    好的。然後關於年度指南、收入指南,我想您提到了對自有品牌的預期發生了變化。25 年收入指南中還包含其他值得注意的細分變化嗎?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • No, not based on what we see right now.

    不,根據我們目前所看到的情況來看並非如此。

  • Jayson Bedford - Analyst

    Jayson Bedford - Analyst

  • Okay. And then last one. Is there a 2Q revenue impact from Skin and Private Label that component? I apologize if I missed it earlier.

    好的。然後是最後一個。皮膚和自有品牌組件對第二季的收入有影響嗎?如果我之前錯過了,我深感抱歉。

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • So for Q2, actually for Integra Skin, that's when we'll start to see a pickup based on the production that we're seeing already. So we'll start to see that business pick up compared to Q1. Private Label, though, will still not see the lift in Q2. That lift will begin in Q3.

    因此,對於第二季度,實際上對於 Integra Skin 而言,根據我們已經看到的產量,我們將開始看到回升。因此,與第一季相比,我們將開始看到業務回升。不過,自有品牌在第二季仍不會出現成長。該提升將於第三季開始。

  • Jayson Bedford - Analyst

    Jayson Bedford - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Craig Bijou, Bank of America.

    美國銀行的克雷格‧比喬 (Craig Bijou)。

  • Craig Bijou - Analyst

    Craig Bijou - Analyst

  • Good morning. Thanks for taking the questions. A couple of follow-ups for me. So Lea, I guess I just wanted to understand, so is the ship hold increase that you guys saw or that you're expecting this year? Is that roughly $10 million? And then I did notice that organic growth for the full year in the guide came down by 60 basis points. So is that the -- is it just from the ship holds?

    早安.感謝您回答這些問題。對我來說還有幾項後續事宜。所以 Lea,我想我只是想了解一下,你們今年看到的船舶載貨量增加了嗎?或者你們預計今年船舶載貨量會增加嗎?那大約是 1000 萬美元嗎?然後我確實注意到指南中全年的有機成長率下降了 60 個基點。那麼,這只是──來自船艙嗎?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Thanks for the question, Craig. So the incremental ship holds that we identified late in Q1 have an annual impact that's projected to be $28 million to $43 million. So if you recall in our February call, at that point in time, we had identified annual impact of about $27 million. When you add on top of that what was newly identified, that's how you get to the range that we called out in our prepared remarks of about $55 million to $70 million is what we're currently projecting as the annual impact for ship holds.

    謝謝你的提問,克雷格。因此,我們在第一季末發現的增量船艙損失預計每年將產生 2,800 萬至 4,300 萬美元的影響。因此,如果您還記得我們二月的電話會議,當時我們已經確定年度影響約為 2700 萬美元。如果再加上新確定的金額,那麼就會得出我們在準備好的評論中提到的範圍,即目前我們預測的每年對船舶艙位的影響約為 5500 萬至 7000 萬美元。

  • So I hope that answers that part of the question. And then -- your second question, Craig or the second part of your question?

    我希望這能回答問題的這一部分。然後──你的第二個問題,克雷格,或是你問題的第二部分?

  • Craig Bijou - Analyst

    Craig Bijou - Analyst

  • Yeah, organic growth. I think in the bridge, it goes from $3 million to $2.4 million. So I was just -- is that just the ship hold impact?

    是的,有機成長。我認為,在橋樑上,這個數字將從 300 萬美元上升到 240 萬美元。所以我只是──那隻是船艙的撞擊嗎?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Yeah. So we held the reported range of our February guide flat, and it does reflect a $10 million tailwind from FX. That was absorbed into the organic piece.

    是的。因此,我們維持了 2 月指南報告範圍的平穩,這確實反映了 FX 帶來的 1000 萬美元的順風。它被有機部分吸收了。

  • Craig Bijou - Analyst

    Craig Bijou - Analyst

  • Okay. But the organic -- I guess I'm just asking because I think in the bridge, you have organic growth -- you had organic growth of 3% for '25 and now it's 2.4%. So I don't know if it was just a ship holder or if there was something else that we should be considering on the underlying growth.

    好的。但有機成長——我想我只是想問一下,因為我認為在橋樑上,你有有機成長——25 年你的有機成長率為 3%,現在是 2.4%。所以我不知道它是否只是一個船舶持有者,或者在潛在的成長方面我們是否應該考慮其他因素。

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Yeah. It was more just -- we kept our reported range flat, and the offset is FX became a tailwind, so the offset is the organic growth did come down slightly.

    是的。這更加公正——我們保持了報告範圍的平穩,而外匯的抵消作用成為了順風,因此有機增長的抵消作用確實略有下降。

  • Craig Bijou - Analyst

    Craig Bijou - Analyst

  • Okay. And then one quick follow-up on the -- on your debt leverage. And I believe that you said that the covenant goes to 4.25 in Q4 and I think you said at the end of Q1, you were at 4.3. So maybe just help us think about how you're thinking about the capital structure, the debt structure going forward?

    好的。然後快速跟進一下您的債務槓桿。我記得您說過,第四季的契約利率會升至4.25,而您在第一季末也說過,當時的契約利率是4.3。所以,能否請您幫我們想想,您對未來的資本結構和債務結構有何看法?

  • Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

    Lea Knight - Chief Financial Officer, Executive Vice President, Principal Financial Officer

  • Certainly. So first, we fully expect to remain within our covenant levels through the end of the year. We are managing our OpEx spend at the low end of our revenue range. So we're pacing our spend to manage profitability very closely. We do have the ability, if necessary to drive incremental OpEx reductions should that become necessary.

    當然。因此,首先,我們完全希望在年底前保持我們的契約水準。我們將營運支出控制在收入範圍的低端。因此,我們正在嚴格控制支出,以管理獲利能力。如果有必要,我們確實有能力推動營運支出的逐步減少。

  • And then we're also keeping open transparent dialogues with our bank partners and lending groups, long-standing investors that we've had to make sure that they also understand how we're closely managing the business for profitability this year. And so for all those reasons, fully believe we'll be able to remain within our covenant levels even with the step down that you noted in Q4.

    然後,我們也與我們的銀行合作夥伴和貸款集團以及長期投資者保持公開透明的對話,我們必須確保他們也了解我們今年如何密切管理業務以實現盈利。因此,基於所有這些原因,我們完全相信,即使出現您在第四季度提到的下降,我們也將能夠保持在我們的契約水平之內。

  • Craig Bijou - Analyst

    Craig Bijou - Analyst

  • Great. Thanks for taking the question.

    偉大的。感謝您回答這個問題。

  • Operator

    Operator

  • I'm showing no further questions in queue at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.

    目前隊列中沒有其他問題。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。