Integra Lifesciences Holdings Corp (IART) 2025 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Integra Lifesciences second quarter 2025 financial results call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Integra Lifesciences 2025 年第二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。

I would now like to hand the conference over to your first speaker today, Chris Ward, Senior Director of Investor Relations. Please go ahead.

現在，我想將會議交給今天的第一位發言者，投資者關係高級總監克里斯沃德 (Chris Ward)。請繼續。

Good morning, and thank you for joining the Integra Lifesciences second 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 announcing our second quarter 2025 financial results. The release and corresponding earnings presentations, which we will reference during the call, are available at integralife.com under Investors, Events and Presentations in a file named second quarter 2025 earnings call presentations. Before we begin, I want to remind you that many of the statements made during this call may be considered forward-looking.

早安，感謝您參加 Integra Lifesciences 2025 年第二季財報電話會議。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，我們發布了一份新聞稿，宣布了我們 2025 年第二季的財務表現。我們將在電話會議中參考的新聞稿和相應的收益簡報可在 integralife.com 的「投資者、活動和簡報」下的名為「2025 年第二季收益電話會議簡報」的文件中查閱。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。

Factors that could cause actual results to differ materially are discussed in the company's Exchange Act Report that are filed with the SEC and in the LOOP. Also in our prepared remarks, we will reference reported inorganic revenue growth. Organic revenue growth excludes the effects of foreign currency, acquisition and divestment. Unless otherwise stated, all disaggregated and franchise-level revenue growth rates are based on organic performance. Lastly, in our comments today, we will reference 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.

該公司向美國證券交易委員會 (SEC) 和 LOOP 提交的《交易法報告》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，我們將參考報告的無機收入成長。有機收入成長不包括外幣、收購和撤資的影響。除非另有說明，所有分類和特許經營等級的收入成長率均基於有機表現。最後，在我們今天的評論中，我們將參考某些非 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。

With that, I will now turn the call over to Mojdeh.

說完這些，我現在將電話轉給 Mojdeh。

Thank you, Chris. Good morning, everyone, and thank you for joining us for our second quarter 2025 earnings call. I would like to start by acknowledging the tremendous work done by our teams across the company to deliver a strong second quarter performance while advancing our priorities. Our transformation is underway and I'm encouraged by the progress we're making in establishing the foundation for operational excellence and a culture of continuous improvement that will drive long-term performance, consistency and reliability across our business. Today, I will walk through the progress we're making on our Compliance Master Plan, provide an update on our operational excellence efforts and close with an overview of our financial results and updated guidance.

謝謝你，克里斯。大家早安，感謝大家參加我們的 2025 年第二季財報電話會議。首先，我要感謝我們公司各團隊所做的大量工作，他們在推進我們的優先事項的同時，取得了強勁的第二季業績。我們的轉型正在進行中，我們在建立卓越營運基礎和持續改進文化方面所取得的進展令我感到鼓舞，這將推動我們整個業務的長期績效、一致性和可靠性。今天，我將介紹我們在合規總體規劃方面取得的進展，介紹我們卓越營運工作的最新情況，最後概述我們的財務表現和最新指引。

Lea will then take you through the financials and our revised outlook in more detail. Let's begin with our progress on the Compliance Master Plan. We continue to execute our Compliance Master Plan as a cornerstone of our turnaround. I'm pleased to share that we completed assessments at all of our internal manufacturing sites ahead of our original Q3 time line with zero related shipholds identified or initiated since our last earnings call. This is a key milestone in our risk reduction and operational readiness efforts.

然後，Lea 將向您更詳細地介紹財務狀況和我們修訂後的展望。讓我們從合規總體規劃的進展開始。我們將繼續執行合規總體規劃，作為我們扭轉局面的基石。我很高興地告訴大家，我們在原定的第三季度時間表之前完成了對所有內部製造基地的評估，自上次收益電話會議以來，沒有發現或啟動任何相關的船舶扣押。這是我們降低風險和營運準備工作的一個重要里程碑。

We have taken the learnings from our site assessments and have begun remediation planning and execution. Our quality, engineering and operations teams working closely with the newly formed transformation and program management office have built a detailed risk-based execution road map that prioritizes efforts aligned with the FDA Quality System Regulations and previous observations.

我們從現場評估中吸取了教訓，並已開始製定補救計劃並實施。我們的品質、工程和營運團隊與新成立的轉型和專案管理辦公室密切合作，制定了詳細的基於風險的執行路線圖，優先考慮符合 FDA 品質系統法規和先前觀察的努力。

This office oversees execution of the risk mitigation plan, including resource allocations, time lines and deliverables. Some of the remediation work will extend into 2026 with continuous improvement becoming a standard element of operating in highly regulated industry. We remain fully committed to transforming our quality management system across our supply chain network and recognize there is still significant work ahead.

該辦公室負責監督風險緩解計畫的執行，包括資源分配、時間表和可交付成果。部分補救工作將延續到 2026 年，持續改善將成為高度監管產業營運的標準要素。我們仍然全力致力於轉變整個供應鏈網路的品質管理體系，並認識到未來仍有大量工作要做。

We are encouraged by the positive outcomes from recent FDA inspections at two of our facilities not covered by the warning letters. Related to our warning letters, we continue to provide regular updates on our actions committed to the FDA. The progress we're making in quality compliance supports our advancement towards the operational strength and agility required to execute consistently across our global network. Together, these capabilities are critical to delivering the reliability and performance our stakeholders expect. Moving to operations, we remain focused on strengthening execution across our global network.

我們對美國食品藥物管理局 (FDA) 最近對我們兩家未被警告信覆蓋的工廠進行的檢查取得了積極結果感到鼓舞。與我們的警告信相關，我們將繼續定期向 FDA 提供我們承諾採取的行動的最新情況。我們在品質合規方面取得的進展支持我們向全球網路一致執行所需的營運實力和敏捷性邁進。總之，這些功能對於實現利害關係人期望的可靠性和性能至關重要。在營運方面，我們仍然專注於加強全球網路的執行力。

We have implemented a new supply chain control tower to drive enhanced visibility, accountability and performance management throughout our global supply chain. We are making good progress at our Braintree facility, which will support the relaunch of SurgiMend and PriMatrix. We remain on track to bring the site online in the first half of 2026 and plan to share our relaunch time lines by the end of this year. The facility's quality management system is on schedule for implementation with equipment installation and qualifications underway. In addition, the site's staffing model has transitioned to its long-term operating structure, ensuring readiness to resume manufacturing operations.

我們實施了新的供應鏈控制塔，以增強整個全球供應鏈的可視性、責任感和績效管理。我們的布倫特里工廠進展順利，這將支援 SurgiMend 和 PriMatrix 的重新推出。我們仍有望在 2026 年上半年上線網站，並計劃在今年年底前分享我們的重新啟動時間表。該設施的品質管理系統正在按計劃實施，設備安裝和資格認證正在進行中。此外，該工廠的人員配置模式已轉變為長期營運結構，確保為恢復生產營運做好準備。

Turning to our financial performance in the second quarter, we delivered global revenue of $415.6 million, exceeding the high-end of our guidance. Reported and organic revenue growth were both down slightly versus the prior year, which was expected and previously communicated during our Q1 earnings call. This was largely due to the impact of shipholds offsetting healthy mid-single digit growth across the portfolio, which underscores continued demand for our differentiated products. Adjusted EPS came in at $0.45 at the top of our guidance range, reflecting strong revenue execution and OpEx management offset by higher remediation costs. A standout this quarter was Integra Skin.

談到我們第二季的財務業績，我們的全球收入達到 4.156 億美元，超過了我們預期的最高水準。報告收入和有機收入成長均較上年略有下降，這是預料之中的，並且在我們第一季收益電話會議上已經傳達過。這主要是由於船艙的影響抵消了整個投資組合中健康的個位數成長，這凸顯了對我們差異化產品的持續需求。調整後的每股盈餘達到 0.45 美元，處於我們指導範圍的上限，反映出強勁的收入執行和營運支出管理，但補救成本的上升有所抵消。本季的佼佼者是 Integra Skin。

Through our manufacturing resiliency and yield improvement efforts, we achieved the company's highest ever production levels in Q2 and expect to maintain normal revenue run rate through the rest of the year. We are also rebuilding safety stocks to improve supply reliability moving forward. As the reimbursement and access dynamic shift in wound care, we are well-positioned with a clear path to restore our full wound reconstruction portfolio. The timing of our Integra Skin production recovery, along with our preparations to restart PriMatrix next year, align well with the recent proposed changes for wound care reimbursement in the outpatient and physician office settings. The established clinical evidence across our portfolio strongly supports the opportunity for us to deliver care beyond the acute care setting.

透過我們的製造彈性和產量提高努力，我們在第二季度實現了公司有史以來最高的生產水平，並預計在今年剩餘時間內保持正常的收入運行率。我們也正在重建安全庫存，以提高未來的供應可靠性。隨著傷口護理的報銷和獲取動態變化，我們已做好準備，擁有明確的途徑來恢復我們的全部傷口重建產品組合。我們的 Integra Skin 生產恢復時間以及我們明年重啟 PriMatrix 的準備工作與最近提出的門診和醫生辦公室環境中傷口護理報銷的變化相吻合。我們產品組合中已建立的臨床證據有力地支持了我們在急性護理環境之外提供護理的機會。

Our continued investments in further clinical evidence will also provide additional support for broader reimbursement. Looking ahead to our financial expectations for the third quarter, we expect revenue between $410 million and $420 million, representing approximately 8% to 10% reported growth. For the full year, we are updating our revenue guidance to a range of $1.655 billion to $1.68 billion. This reflects increased visibility into our shipholds and remediation outlook, including an expectation that we will not experience any material new holds related to the Compliance Master Plan for the remainder of the year. For Q3, we expect adjusted EPS between $0.40 and $0.45 and we are maintaining our full year EPS guidance range of $2.19 to $2.29.

我們對進一步臨床證據的持續投資也將為更廣泛的報銷提供額外支持。展望第三季的財務預期，我們預期營收在 4.1 億美元至 4.2 億美元之間，成長約 8% 至 10%。我們將全年營收預期上調至 16.55 億美元至 16.8 億美元。這反映了我們對船舶持有量和補救前景的更加清晰的認識，包括我們預期在今年剩餘時間內我們不會遇到與合規總體規劃相關的任何重大新持有量。對於第三季度，我們預計調整後的每股盈餘將在 0.40 美元至 0.45 美元之間，並將全年每股收益預期範圍維持在 2.19 美元至 2.29 美元之間。

Before turning the call over to Lea, I want to emphasize the long-term focus and an initiative we are taking to drive additional shareholder value. We remain confident in our leadership positions in neurosurgery and tissue technology and the sustained demand in the attractive market we serve. We are laying the foundation for sustainable growth and profitability through strategic investments and disciplined cost management. This includes enhancing supply chain reliability and executing on our Compliance Master Plan. Additionally, as part of our broader transformation, we are optimizing our operating model to accelerate decision-making, strengthen accountability and enable scalable execution while embedding a culture of continuous improvement.

在將電話轉給 Lea 之前，我想強調一下我們的長期關注點以及我們為增加股東價值而採取的舉措。我們對自己在神經外科和組織技術領域的領導地位以及我們所服務的有吸引力的市場的持續需求充滿信心。我們透過策略性投資和嚴格的成本管理為永續成長和獲利奠定基礎。這包括提高供應鏈可靠性和執行我們的合規總體規劃。此外，作為我們更廣泛轉型的一部分，我們正在優化我們的營運模式，以加快決策、加強問責制並實現可擴展的執行，同時植入持續改進的文化。

These efforts will allow us to move with greater agility, reduce complexity and unlock meaningful value in quarters ahead. Based on our preliminary work in the initial phase of this initiative, we expect to deliver minimum annualized savings of $25 million to $30 million over the next 12 to 18 months by driving out inefficiencies and redundant costs. Optimizing our cost structure is essential to maintaining long-term competitiveness, particularly in light of the evolving tariff and macroeconomic environment. This is a foundational first step in a larger strategic initiative to drive sustained margin expansion. I look forward to keeping you updated on this initiative in the coming quarters.

這些努力將使我們能夠更靈活地行動，降低複雜性並在未來幾季釋放有意義的價值。根據我們在該計劃初始階段的初步工作，我們預計透過消除低效率和冗餘成本，在未來 12 至 18 個月內實現每年至少 2500 萬至 3000 萬美元的年度節省。優化我們的成本結構對於維持長期競爭力至關重要，尤其是在不斷變化的關稅和宏觀經濟環境下。這是推動利潤率持續擴張的更大策略舉措的基礎性的第一步。我期待在未來幾季內向您通報這項舉措的最新進展。

With that, I will now turn the call over to Lea.

說完這些，我現在將電話轉給 Lea。

Thank you, Mojdeh. Let's take a more detailed look at our second quarter financial highlights starting on slide 5. Total revenues for the quarter were $415.6 million, representing a decline of approximately 0.6% on a reported basis and 1.4% on an organic basis compared to the same period last year. Reported revenues included a foreign exchange tailwind of approximately 80 basis points. Organic revenue performance exceeded our expectations despite supply disruptions related to remediation efforts under our Compliance Master Plan.

謝謝你，Mojdeh。讓我們從第 5 張投影片開始更詳細地了解第二季的財務亮點。本季總營收為 4.156 億美元，與去年同期相比，報告基礎下降約 0.6%，有機基礎下降 1.4%。報告的收入包括約 80 個基點的外匯順風。儘管由於我們的合規總體規劃下的補救措施而導致供應中斷，但有機收入表現仍超出了我們的預期。

Adjusted earnings per share for the quarter were $0.45, representing a 29% decline compared to the second quarter of 2024. On a GAAP basis, we reported a goodwill impairment charge of approximately $511 million during the quarter. This charge was identified through our goodwill testing and was primarily driven by macroeconomic uncertainties such as tariff and risks around the supply recovery efforts, which were reflected in the decline of our market capitalization over Q2. I want to emphasize that this impairment charge is noncash and reflects accounting requirements under GAAP. It has no impact on our cash position or liquidity and will not affect our ongoing operations or our ability to execute our strategic priorities.

本季調整後每股收益為 0.45 美元，與 2024 年第二季相比下降 29%。根據 GAAP 計算，我們本季報告的商譽減損費用約為 5.11 億美元。這項費用是透過我們的商譽測試確定的，主要是由關稅等宏觀經濟不確定性和供應恢復工作風險所驅動，這反映在我們第二季度的市值下降中。我想強調的是，這筆減損費用是非現金的，反映了 GAAP 下的會計要求。它不會影響我們的現金狀況或流動性，也不會影響我們正在進行的營運或執行策略重點的能力。

Gross margin for the quarter was 60.7%, down 450 basis points year over year, primarily due to higher operational costs associated with shipholds remediation. Adjusted EBITDA margin was 17.1%, down 290 basis points, reflecting the decline in gross margin. This was partially offset by disciplined expense management as we continue to prioritize investments in our quality systems in efforts to build operational resilience and execution capability. Operating cash flow for the quarter was $9 million.

本季毛利率為 60.7%，年減 450 個基點，主要原因是與船艙修復相關的營運成本增加。調整後 EBITDA 利潤率為 17.1%，下降 290 個基點，反映了毛利率的下降。由於我們繼續優先投資於品質體系，以增強營運彈性和執行能力，因此嚴格的費用管理在一定程度上抵消了這種影響。本季經營現金流為 900 萬美元。

Turning to slide 6, let's review the revenue highlights from our Codman Specialty Surgical segment. CSS reported second quarter revenue of $304 million, reflecting growth of 0.7% on a reported basis and a decline of 0.3% on an organic basis. Global neurosurgery revenues increased 0.3% organically, driven by strong performance in our CUSA platform, the Aurora Surgiscope, Mayfield cranial stabilization systems, DuraSeal, BactiSeal and CereLink monitors.

翻到第 6 張幻燈片，讓我們回顧一下 Codman Specialty Surgical 部門的收入亮點。CSS 公佈第二季營收為 3.04 億美元，報告期間內成長 0.7%，有機成長率為 0.3%。全球神經外科收入有機成長 0.3%，這得益於我們的 CUSA 平台、Aurora Surgiscope、Mayfield 顱骨穩定係統、DuraSeal、BactiSeal 和 CereLink 監視器的強勁表現。

This growth was offset by the impact of shipholds, which particularly affected our advanced energy, dural access and repair and neuro-monitoring franchises. Despite these challenges, demand across the neurosurgery portfolio remained strong, with mid-single digit growth in products not experiencing supply constraints. In our ENT business, we remain encouraged by the ongoing integration of Acclarent, which contributed approximately $30 million in revenue this quarter.

這一成長被船艙的影響所抵消，這尤其影響了我們的先進能源、硬腦膜通路和修復以及神經監測特許經營權。儘管面臨這些挑戰，神經外科產品組合的需求依然強勁，未受供應限制的產品實現了中等個位數成長。在我們的耳鼻喉科業務中，我們對 Acclarent 的持續整合感到鼓舞，該公司本季貢獻了約 3,000 萬美元的收入。

While we're pleased with the overall integration progress and prospects for this business, growth for the quarter came in below our expectations. This was primarily due to reimbursement-driven market pressure in the Sinuplasty Balloon segment, as well as timing of capital cut sales. These headwinds offset double digit growth in AERA Eustachian Tube Balloon Dilation and our TruDi navigated disposables. Second quarter capital sales grew low single digits primarily due to CUSA capital sales. Our global capital funnel remains strong and well-positioned to support future growth.

雖然我們對該業務的整體整合進展和前景感到滿意，但本季的成長低於我們的預期。這主要是由於鼻竇成形球囊領域的報銷驅動市場壓力，以及資本削減銷售時機。這些不利因素抵消了 AERA 咽鼓管球囊擴張術和我們的 TruDi 導航一次性設備的兩位數成長。第二季資本銷售額成長低個位數，主要因為 CUSA 資本銷售額。我們的全球資本管道依然強勁，並有能力支持未來的成長。

In our Instruments portfolio, revenue declined low single digits driven by a difficult comparison in the alternate site channel following strong performance in the prior year. This was partially offset by growth across our acute care business. International performance within CSS declined by low single digits primarily attributable to the shiphold, which offset strong underlying demand from our international markets, including high single digit growth in China.

在我們的儀器產品組合中，由於前一年表現強勁，替代站點管道的比較困難，導致收入出現低個位數下降。這被我們的急性護理業務的成長部分抵消了。CSS 的國際業績下降了低個位數，主要原因是船舶庫存下降，抵消了我們國際市場強勁的潛在需求，包括中國高個位數的成長。

Moving to our Tissue Technology segment on slide 7. Tissue Technology revenues were $111.6 million, down approximately 4% on both a reported and organic basis compared to the prior year. Within wound reconstruction, we saw strong underlying growth across the portfolio, including double digit growth from DuraSorb and Integra Skin. Growth in Integra Skin was supported by both continued demand strength and improved production output, while DuraSorb's performance was driven primarily by sustained market demand. We also saw high single digit growth in MicroMatrix and Cytal.

前往投影片 7 上的組織技術部分。紙巾技術收入為 1.116 億美元，與前一年相比，報告收入和有機收入均下降約 4%。在傷口重建領域，我們看到整個產品組合都實現了強勁的潛在成長，其中包括 DuraSorb 和 Integra Skin 的兩位數成長。Integra Skin 的成長得益於持續強勁的需求和產量的提高，而 DuraSorb 的業績主要受到持續的市場需求的推動。我們也看到 MicroMatrix 和 Cytal 實現了高個位數成長。

However, this growth was offset by the impact of previously announced shipholds specifically related to MediHoney. In our private label business, sales declined 5.9% year over year primarily due to a component supply delay and softer commercial demand experienced by one of our private label partners. International sales in Tissue Technology has declined low double digits, reflecting strong growth in Integra Skin that was more than offset by the impact of the MediHoney shiphold.

然而，這一增長被先前宣布的與 MediHoney 特別相關的船舶持有量的影響所抵消。在我們的自有品牌業務中，銷售額年減 5.9%，主要原因是我們的一個自有品牌合作夥伴遭遇零件供應延遲和商業需求疲軟。組織科技業務的國際銷售額下降了兩位數，反映出 Integra Skin 業務的強勁成長被 MediHoney 控股公司的影響所抵消。

Turning to slide 8, I'll now review our balance sheet, capital structure and cash flow. During the second quarter, operating cash flow was $8.9 million and free cash flow was negative $11.2 million, reflecting our continued capital investments in key infrastructure. As of June 30, net debt stood at $1.59 billion and our consolidated total leverage ratio was 4.5 times, which remains within our current maximum allowable leverage ratio of 5 times. This ratio extends through the second quarter of 2026 following the amendment to our credit agreement executed during the second quarter.

翻到第 8 張投影片，我現在將回顧我們的資產負債表、資本結構和現金流。第二季度，營運現金流為 890 萬美元，自由現金流為負 1,120 萬美元，這反映了我們對關鍵基礎設施的持續資本投資。截至 6 月 30 日，淨債務為 15.9 億美元，我們的合併總槓桿率為 4.5 倍，仍在我們目前允許的最高槓桿率 5 倍範圍內。在我們於第二季實施信貸協議修訂後，該比率將延續至 2026 年第二季。

We fully anticipate being well below our maximum allowable leverage ratio when the amendment expires. We ended the quarter with total liquidity of $1.1 billion including $254 million in cash and short-term investments with the remainder available under our revolving credit facility. As a reminder, we plan to use this facility to satisfy the convertible bond maturity in the third quarter.

我們完全預計，修正案到期後，槓桿率將遠低於我們允許的最大槓桿率。截至本季末，我們的總流動資金為 11 億美元，其中包括 2.54 億美元的現金和短期投資，其餘部分可透過我們的循環信貸安排使用。提醒一下，我們計劃使用此工具來滿足第三季的可轉換債券到期。

If you turn to slide 9, that will provide our consolidated revenue and adjusted earnings per share guidance for the third quarter and full year 2025. For the full year, we are updating our revenue guidance to a range of $1.655 billion to $1.68 billion. This updated range reflects a more refined view of the full year impact on shipholds informed by the progress we've made in executing the Compliance Master Plan and the increased visibility that has come with it. When we issued our original guidance, we included a broad range of $90 million to $150 million to account for potential shipping impacts related to the Compliance Master Plan.

如果您翻到第 9 張投影片，它將提供我們對 2025 年第三季和全年的綜合收入和調整後每股盈餘的指引。我們將全年營收預期上調至 16.55 億美元至 16.8 億美元。這項更新範圍反映了我們對全年船舶影響的更細緻的了解，這一了解源於我們在執行合規總體規劃方面取得的進展以及隨之而來的可見性的提高。當我們發布最初的指導意見時，我們納入了 9,000 萬至 1.5 億美元的廣泛範圍，以考慮與合規總體規劃相關的潛在航運影響。

As we have said previously, that range was intentionally wide given the early stage of our plan and the number of unknowns at the time. Since then, we've completed our site assessments and now have a clear picture of the full year impact. We've refined our assessment of shipholds and related remediation for the year to be approximately $100 million, which is $30 million more than reported last quarter.

正如我們之前所說，考慮到我們計劃的早期階段以及當時未知數的數量，這個範圍是故意設得很寬的。從那時起，我們完成了現場評估，現在對全年影響有了清晰的了解。我們對今年船舶停泊處及相關修復的評估已調整至約 1 億美元，比上一季報告的數字高出 3,000 萬美元。

This increase is solely due to extended remediation time line for a few of our previously communicated shipholds. We have not identified any new Compliance Master Plan related shipholds since our first quarter earnings call. Importantly, based on completion of manufacturing site assessment, we do not anticipate any new material shipholds in the second half of the year. The lower end of our updated guidance range reflects extended time lines required to complete remediation efforts already communicated and in progress, while the top end of our range reflects the potential for stronger demand and a more rapid return to market for select products in our portfolio. Based on this revised outlook, we now expect full year reported revenue growth of approximately 2.8% to 4.3% and organic growth of approximately 0.6% to 2.1%.

此次增加完全是由於我們先前通報的幾艘船艙的修復時間延長所致。自第一季財報電話會議以來，我們尚未發現任何新的與合規總體規劃相關的船舶持有。重要的是，根據製造現場評估的完成情況，我們預計下半年不會有任何新的材料船艙。我們更新後的指導範圍的下限反映了完成已經傳達和正在進行的補救措施所需的延長時間，而我們範圍的上限反映了我們產品組合中的部分產品需求更強勁和更快重返市場的潛力。根據這項修訂後的展望，我們現在預計全年報告營收成長約為 2.8% 至 4.3%，有機成長約為 0.6% 至 2.1%。

For the full year 2025, we are maintaining our adjusted EPS guidance in the range of $2.19 to $2.29. This outlook incorporates our updated revenue expectations, remediation costs, ongoing compliance and manufacturing costs and increased interest expense. These pressures are being offset by disciplined cost management and updated tariff-related policy changes and mitigation since our May guidance. For the third quarter, we expect revenues to be in the range of $410 million to $420 million, representing reported growth between 7.7% and 10.3%. We expect organic growth between 7.3% and 9.9%.

我們將2025年全年調整後每股盈餘預期維持在2.19美元至2.29美元之間。該預期涵蓋了我們更新後的收入預期、補救成本、持續的合規和製造成本以及增加的利息支出。自從我們在五月發布指導意見以來，這些壓力正被嚴格的成本管理和更新的關稅相關政策變更和緩解措施所抵消。對於第三季度，我們預計營收將在 4.1 億美元至 4.2 億美元之間，成長率在 7.7% 至 10.3% 之間。我們預計有機成長率在 7.3% 至 9.9% 之間。

Our forecast reflects continued strong global demand for our products, normal second half seasonal sequential improvement and the benefit of improved production yields for Integra Skin and others supply recovery. For the third quarter, we expect EPS to be in the range of $0.40 to $0.45, reflecting the effects of longer remediation and the impact of (inaudible).

我們的預測反映了全球對我們產品的持續強勁需求、下半年正常的季節性環比改善以及 Integra Skin 和其他供應恢復的生產收益提高的好處。對於第三季度，我們預計每股收益將在 0.40 美元至 0.45 美元之間，這反映了長期補救措施的影響以及（聽不清楚）。

For additional details, please refer to slide 10, which outlines the key assumptions supporting both our third quarter and full-year guidance.

有關更多詳細信息，請參閱幻燈片 10，其中概述了支持我們第三季度和全年指引的關鍵假設。

I will now turn the call over to Mojdeh to conclude our prepared remarks.

現在我將把電話交給 Mojdeh 來結束我們準備好的演講。

Thank you, Lea. To close, this quarter was all about focus, execution and momentum. We made real measurable progress in building the foundation for what comes next. While there is more work ahead on transformation of our quality management system, the Compliance Master Plan is proceeding as planned and remediation efforts are underway. At the same time, we're focused on restoring supply reliability, strengthening operational discipline and delivering on our financial commitments.

謝謝你，Lea。總而言之，本季的重點是重點、執行力和動力。我們在為下一步工作奠定基礎方面取得了真正可衡量的進展。雖然我們在品質管理系統轉型方面還有更多工作要做，但合規總體規劃正在按計劃進行，補救工作正在進行中。同時，我們致力於恢復供應可靠性、加強營運紀律和履行財務承諾。

We're also driving cost efficiencies to restore the earnings power of the business and generate margin expansion, reinforcing our ability to deliver meaningful return to our shareholders. This marks a significant step in our shift from stabilization to transformation and the opportunity ahead is exciting. We operate in highly attractive markets with strong fundamentals and durable long-term demand for our differentiated portfolio. Our plans for obtaining PMA approval for SurgiMend and DuraSorb are underway, unlocking our potential in implant-based breast reconstruction. In addition, the proposed Medicare payment and LTD changes will favor evidence-backed cost-effective wound reconstruction products, positioning us well for future growth in multiple types of care.

我們也致力於提高成本效率，恢復業務獲利能力並擴大利潤率，增強我們為股東帶來豐厚回報的能力。這標誌著我們從穩定到轉型中邁出了重要一步，未來的機會令人興奮。我們在極具吸引力的市場中運營，市場基本面強勁，並且對我們差異化產品組合有著長期持久的需求。我們正在進行 SurgiMend 和 DuraSorb 的 PMA 批准獲取計劃，以釋放我們在基於植入物的乳房重建方面的潛力。此外，擬議的醫療保險支付和 LTD 變更將有利於有證據支持的具有成本效益的傷口重建產品，為我們未來在多種類型的護理中的增長做好準備。

I remain energized by the significant opportunity to position the company for sustainable growth and long-term value creation. The foundational work we're doing today will allow us to fully realize the value of our portfolio, accelerate growth and drive long-term value for our shareholders.

我仍然對公司實現可持續成長和長期價值創造的重大機會感到振奮。我們今天所做的基礎工作將使我們能夠充分實現投資組合的價值，加速成長並為股東創造長期價值。

Operator, please open the line for questions.

接線員，請打開熱線以回答問題。

(Operator Instructions)

（操作員指示）

Vik Chopra, Wells Fargo.

喬普拉（Vik Chopra），富國銀行。

Two for me. First, I would love to get your thoughts around the CMS' proposed 2026 reimbursement changes aimed to control overutilization and spending on skin substitutes. Can you maybe just remind us what impact this has on Integra and what percentage of your products are exposed? And then I had a quick follow-up, please.

對我來說是兩個。首先，我很想聽聽您對 CMS 提出的 2026 年報銷變化的看法，該變化旨在控制皮膚替代品的過度使用和支出。您能否提醒我們這對 Integra 有什麼影響以及您的產品暴露的百分比是多少？然後我再快速跟進。

Yeah. So I just want to make sure that I mention, first of all, a reminder that majority of our business is in the in-hospital setting, in the acute care. And so we don't see an immediate short-term impact of these changes. However, long term, for sure, we are very encouraged by the changes that they're proposing because obviously, it's going to favor the products that are cost-effective as well as having strong evidence behind them. So we are encouraged by that.

是的。因此，我首先要提醒大家的是，我們的大部分業務是在院內環境中，在急性照護中。因此，我們不會看到這些變化的直接短期影響。然而，從長遠來看，我們肯定會對他們提出的改變感到非常鼓舞，因為顯然，這將有利於具有成本效益且有強有力證據支持的產品。所以我們對此感到鼓舞。

And long term, there's definitely a lot more opportunity for our wound reconstruction portfolio as we leverage the clinical evidence that we have been putting behind this product line as well as continuing to strategize as we move forward into our long-range plan, what the longer-term opportunity would be for us to be able to leverage the changes that are being proposed. So that's the way we see the opportunity right now. It will be mainly in the future and we're building towards it.

從長遠來看，隨著我們利用該產品線背後的臨床證據，並在推進長期計劃時繼續制定策略，我們的傷口重建產品組合肯定會有更多機會，長期機會將是什麼，讓我們能夠利用正在提出的變革。這就是我們現在看到的機會。這將主要發生在未來，我們正在為此努力。

Great. And then my follow-up question, your Q3 EPS guide, I think, came in below the Street, but you maintained your guide for the full year. That implies a pretty significant step-up in the fourth quarter. Maybe just walk us through what's going on there and how we should think about modeling the back half of the year, specifically Q4.

偉大的。然後我的後續問題是，我認為您的第三季每股盈餘指引低於華爾街的預期，但您維持了全年的指引。這意味著第四季將出現相當顯著的成長。也許只是向我們介紹那裡發生的事情以及我們應該如何考慮對下半年，特別是第四季度進行建模。

Yeah. So a couple of things. So let me talk about -- a little bit about the revenue step-up in the back half and then address specifically the EPS question. So as you look at our Q3 guide from a revenue perspective, we're guiding to revenue that is consistent with what we delivered in Q2. And that's actually very consistent with what we've seen in the past in years where we haven't had significant supply disruption.

是的。有幾件事。因此，讓我先談談下半年的營收成長情況，然後再具體討論每股盈餘的問題。因此，當您從收入角度查看我們的第三季指南時，我們指導的收入與第二季的收入一致。這實際上與我們過去幾年所看到的情況非常一致，當時我們沒有嚴重的供應中斷。

As we get into Q4, we are calling a revenue step-up of about $38 million going from Q3 to Q4. That's driven by two factors. 60% of that is going to be driven by the normal seasonal lift that we see on our business, combined with the very strong momentum that we've been seeing on Integra Skin. The other 40% is going to be driven by the supply recovery. So we've talked about shipholds.

隨著我們進入第四季度，我們預計第四季度的收入將從第三季度增加約 3800 萬美元。這是由兩個因素驅動的。其中 60% 將受到我們業務中看到的正常季節性成長的推動，加上我們在 Integra Skin 上看到的非常強勁的發展勢頭。其餘 40% 將由供應復甦推動。我們已經討論了船艙。

Earlier in the year, we do anticipate seeing recovery on some of those items and that will help contribute to the lift that we're expecting for Q4. And seeing that sort of step-up behind the supply recovery is not unusual. We did also see that in Q4 a year ago. So it's going to be the revenue lift that drives kind of that, also the EPS lift that we're seeing in the back half. We'll also get beyond some of the headwinds that we saw from a gross margin perspective. That will contribute to overall EPS. And in total, EPS for Q4 will be order of magnitude, not too different than where we were a year ago.

今年早些時候，我們確實預計其中一些產品將出現復甦，這將有助於實現我們預期的第四季成長。供應復甦背後的這種加速並不罕見。我們在去年第四季也看到過這種情況。因此，推動這一成長的將是收入的成長，也是我們在下半年看到的每股盈餘的成長。我們還將克服從毛利率角度看到的一些阻力。這將有助於整體每股收益。總體而言，第四季的每股盈餘將呈現數量級成長，與一年前相比不會有太大差別。

(Operator Instructions)

（操作員指示）

Matt Taylor, Jefferies.

馬特泰勒，傑富瑞。

Great. This is Young Li in for Matt. I guess to begin, just on the shipholds and the related compliance programs, I mean, it seems like the manufacturing review came in a little bit earlier and better than expected. I wanted to just get a better sense about related to the shipholds, how much lingers and impacts can happen in 4Q '25 and exiting the year? And how much potential risk is there to 2026?

偉大的。這是取代 Matt 的 Young Li。我想先談談船艙和相關的合規計劃，我的意思是，製造審查似乎比預期來得更早一些，而且更好一些。我只是想更了解與船艙相關的情況，在 2025 年第四季和年底會發生多少持續影響？到 2026 年還有多少潛在風險？

So to your point, and as Mojdeh shared in her prepared remarks, we've seen great progress from a site assessment perspective. We are kind of a little more than halfway through the year at this point. We've completed those site assessments and that has given us greater confidence in the estimate that we provided. Again, our current estimate is about $100 million of an impact in this year. That confidence is also supported by the strong execution of our teams.

所以正如你所說，正如 Mojdeh 在她準備好的演講中分享的那樣，從現場評估的角度來看，我們已經看到了巨大的進展。到目前為止，今年已經過了一半多一點。我們已經完成了這些現場評估，這使我們對所提供的估算更有信心。再次，我們目前估計今年的影響約為 1 億美元。這種信心也得到了我們團隊強大執行力的支持。

We prioritize the highest work stream areas first. That's how we said we would execute. That's how we did and that also is contributing to our confidence, coupled with the fact that we didn't find any new CMP-related holds in Q2. So all of those things are allowing us to identify what we believe the impact for 2025 will be, which is $100 million. And at this point, aren't projecting any additional unidentified holds as part of that number.

我們首先優先考慮工作流程最高的領域。這就是我們所說的執行方式。我們就是這麼做的，這也增強了我們的信心，再加上我們在第二季度沒有發現任何新的與 CMP 相關的持有情況。因此，所有這些因素使我們能夠確定我們認為 2025 年的影響，即 1 億美元。目前，我們還沒有預測到還有任何未確定的額外持有量。

The increase that we are reflecting this quarter of about $30 million from what we communicated last quarter is purely due to remediation time lines for the holds that were already identified as of Q1. So that speaks to basically for the balance of the year, we'll see a delay in some of the supply recovery. But again, as I mentioned, in our second half lift, we do expect Q4 to see a step-up in part due to some of those shipholds being released. As we -- from a remediation standpoint, as you talk about 2026, we do see -- there will be some carryover remediation work into 2026. But at this point, we're not providing any additional -- we're not providing guidance today on 2026.

本季我們反映的成長比上一季增加了約 3000 萬美元，這純粹是由於截至第一季度已經確定的暫停的補救時間表。因此，這基本上意味著，就今年的餘額而言，我們將看到部分供應恢復的延遲。但正如我所提到的，在下半年的成長中，我們確實預期第四季會出現成長，部分原因是部分船舶被釋放。從補救的角度來看，正如您所說，2026 年我們確實看到，一些補救工作將會延續到 2026 年。但目前，我們不會提供任何額外的資訊——我們今天不會提供有關 2026 年的指導。

We'll do that as part of our Q4 call in February. But from a shiphold perspective, given the greater visibility and clarity that we now have around the CMP, we don't plan to continue to talk about shiphold separately. This will be kind of baked in as part of how we guide going forward now that we have a better view of what's in front of us.

我們將在二月的第四季電話會議上討論此事。但從船艙角度來看，鑑於我們現在對 CMP 的了解和清晰度更高，我們不打算繼續單獨討論船艙問題。現在我們對眼前的事物有了更好的認識，這將成為我們未來指導方式的一部分。

If I can add a couple of points to Lea's answer. We have spent and come a long way in -- so far this year in terms of focusing our efforts on mitigating risks and also work on improving the predictability that we have on our performance. And I think we are at a stage right now, as Lea explained, that we feel comfortable about our line of sight for the rest of the year. Come 2026, my expectation of our entire team is to continue the momentum that we built in Q2 in order to deliver, first of all, our commitments on the second half and then bring in 2026 even a more ramped-up accelerated momentum in order for us to be able to reliably predict the results that -- and the expectations that the Street should have of us. So just wanted to make sure that I mention that.

如果我可以對 Lea 的回答補充幾點的話。今年到目前為止，我們在集中精力降低風險和提高業績可預測性方面已經付出了很多努力，也取得了很大進展。正如 Lea 所解釋的那樣，我認為我們現在處於一個階段，我們對今年剩餘時間的前景感到滿意。到 2026 年，我對我們整個團隊的期望是繼續保持我們在第二季度建立的勢頭，首先兌現我們對下半年的承諾，然後在 2026 年帶來更加強勁的加速勢頭，以便我們能夠可靠地預測結果——以及華爾街對我們的期望。所以只是想確保我提到了這一點。

Great. That's very helpful. And then I guess a follow-up, wanted to get your view on basically your ability to win back customers and accounts and the amount of investment you might have to potentially do to do that. How is the feedback so far from some of your reps as well as customers and sort of their confidence that after supply shows up, they will be able to win back some of these lost customers?

偉大的。這非常有幫助。然後我想問後續問題，我想了解您對贏回客戶和帳戶的能力的看法，以及為了實現這一目標您可能需要進行的投資金額。到目前為止，你們的一些銷售代表和客戶的回饋如何？他們對供貨到位後能否贏回部分流失顧客的信心如何？

Yeah. Great question. When -- if you're considering the products that we put on shipholds, we have seen consistently quarter after quarter that once the products come off shipholds, we see the product move unless there have been products that get used immediately on a particular case where you may have lost that case. But for the most part, as we have production and supply available, we have not encountered any problems being able to get that business back. Now when you talk about products like PriMatrix and SurgiMend that have been off the market, of course, there's other substitutes that are being used instead of them.

是的。好問題。如果您考慮我們放在船艙中的產品，我們每個季度都會看到，一旦產品從船艙中運出，我們就會看到產品移動，除非有些產品在特定情況下立即使用，否則您可能會輸掉該案件。但在大多數情況下，由於我們有生產和供應，我們在恢復業務方面沒有遇到任何問題。現在，當您談論已經退出市場的 PriMatrix 和 SurgiMend 等產品時，當然，還有其他替代品可以取代它們。

And we have more work to do there. Once we bring those products into the market, reintroduce them, we are not underestimating the lift that's going to be required for us to gain some of that business back -- all of that business back. But we're very confident. It's a very strong market, $800 million market. It's growing at high single, low double digit.

我們還有更多的工作要做。一旦我們將這些產品帶入市場並重新推出它們，我們就不會低估重新獲得部分業務——所有業務——所需的提升。但我們非常有信心。這是一個非常強大的市場，價值 8 億美元。它正以高個位數到低兩位數的速度成長。

We have a great position with the products that have that clinical support behind them and we are confident in our ability to be able to do it. It may take us some time, but we are very confident in our ability to be able to take the share back.

我們的產品擁有良好的市場地位，並且擁有臨床支持，我們有信心能夠做到這一點。這可能需要一些時間，但我們對奪回份額的能力非常有信心。

Robert Marcus, JPMorgan.

摩根大通的羅伯特馬庫斯。

This is Lily on for Robbie. Maybe just starting on revenue growth. The reported range is moving up, but on an organic basis, the midpoint is moving a meaningful step lower. So can you talk through that a bit? It sounds like you have better visibility into supply. There shouldn't be any incremental shipholds. So what's driving the step-down for the full year?

這是 Lily 為 Robbie 表演的。收入成長可能才剛開始。報告的範圍正在上升，但從有機基礎來看，中點正在顯著下降。能稍微談一下嗎？聽起來您對供應有了更好的了解。不應有任何增量船舶停泊。那麼，是什麼原因導致全年油價下跌呢？

So to your point, from a shiphold -- our previous range did allow for a range of about $90 million to $150 million in shipholds. We're now at $100 million, which puts us kind of slightly below our previous top end of the range. And so that was the reason to adjust it down. To your point, in addition to that, we also have reflected about a $25 million to $30 million market demand decline expectation and that is a combination of a few things. It's the slowdown that we've seen in private label related specifically to one of our private label partners who is seeing demand headwinds due to competitive pressures, coupled with the Q2 performance we saw on ENT and while we still believe the back half will drive higher growth than what we saw in Q2, it won't entirely overcome that headwind.

所以就您的觀點而言，從船艙角度來看——我們之前的範圍確實允許船艙價值在 9000 萬美元到 1.5 億美元之間。現在我們的估值為 1 億美元，略低於之前的最高估值。這就是將其調低的原因。正如您所說，除此之外，我們還反映了約 2500 萬至 3000 萬美元的市場需求下降預期，這是多種因素的綜合作用。我們在自有品牌領域看到的放緩，具體與我們的一家自有品牌合作夥伴有關，由於競爭壓力，該合作夥伴面臨著需求逆風，再加上我們在 ENT 上看到的第二季度表現，雖然我們仍然相信下半年將推動比第二季度更高的增長，但它不會完全克服這種逆風。

And so that's factored in as part of that. And then the last piece is just a slightly slower ramp on market recapture for our supply recovery. Again, part of our shiphold increase is a reflection of longer remediation time lines on some of the recoveries. And so we've also put in there an assumption that we'll have slightly slower market recapture on that piece.

因此，這是其中的一部分。最後一點是，我們的供應恢復的市場重新佔領速度會稍微慢一些。再次，我們船舶保有量增加的部分原因是部分恢復作業的補救時間延長。因此，我們也假設我們在這方面的市場重新佔領速度會稍微慢一些。

Got it. That's helpful. And then just as a follow-up, gross margin came in softer and you're pointing to a lower number for the full year as well. So can you talk about the softness in the quarter and what's changing on a full year basis when tariffs are better than when you last reported and supply should hopefully continue to improve?

知道了。這很有幫助。然後作為後續問題，毛利率有所下降，全年毛利率也較低。那麼，您能否談談本季的疲軟表現以及全年情況有何變化？今年的關稅比您上次報告時有所改善，供應有望繼續改善嗎？

Absolutely. So for Q2 gross margins, the decline was driven largely by manufacturing variances. We were down about 450 basis points year-on-year, about 400 basis points of that driven by manufacturing variances. And that's largely attributable to overhead inefficiencies that we saw related to our shipholds, some under-absorption due to the private label volume changes that I mentioned, coupled with tariffs from a year-on-year perspective. We also saw higher E&O and scrap, again, associated with the remediation work that's underway and that was slightly offset by some favorable mix, specifically on Integra Skin with a much stronger performance in Q2 this year versus a year ago.

絕對地。因此，第二季毛利率的下降主要是由於製造差異造成的。與去年同期相比，我們的利潤下降了約 450 個基點，其中約 400 個基點是由於製造差異造成的。這在很大程度上歸因於我們發現的與船艙相關的間接費用效率低下，由於我提到的私人品牌數量變化導致的一些吸收不足，再加上同比關稅。我們也看到 E&O 和廢品率上升，這同樣與正在進行的修復工作有關，但被一些有利因素稍微抵消了，特別是 Integra Skin，今年第二季度的表現比去年同期強勁得多。

So to your point, we expect our second half gross margins to remain largely flat to what we've seen in the first half as we continue to work through our remediation efforts. On a full year basis, we are now projecting gross margins to be down by about 300 basis points versus 2024. That said, I think it's also noteworthy that the headwinds we experienced in gross margins for Q2 were offset by much better OpEx management, which allowed us to deliver EBITDA margins that were very consistent with our expectations. And that also will largely be true for the balance of the year.

所以正如您所說，隨著我們繼續採取補救措施，我們預計下半年的毛利率將與上半年基本持平。從全年來看，我們目前預計毛利率將比 2024 年下降約 300 個基點。話雖如此，我認為同樣值得注意的是，我們在第二季度毛利率方面遇到的阻力被更好的營運支出管理所抵消，這使我們能夠實現與我們的預期非常一致的 EBITDA 利潤率。這對於今年餘下的時間來說也基本如此。

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

This is Izzy on for Ryan. Just to start with the ENT business, I heard your commentary about how the growth in the quarter came in below expectations. So I was just curious if you could provide a little bit more color around the headwinds that you called out and the expectations for the back half of the year. Additionally, if we think about a little bit longer term, where do you see a sustainable growth rate for the ENT business?

這是 Izzy 為 Ryan 表演的。首先從耳鼻喉科業務開始，我聽到了您關於本季成長低於預期的評論。所以我只是好奇您是否可以提供更多關於您所指出的不利因素以及對今年下半年的預期的信息。此外，如果我們考慮得更長遠一些，您認為耳鼻喉業務的可持續成長率是多少？

Yeah, we did have a softer Q2 growth, but it was mainly due to a tough comp, which was last year, we had strong capital sales in the same period. We saw strong double digit growth in AERA for Eustachian Tube Balloon Dilation as well as the TruDi navigated disposables. On the Balloon Sinuplasty side, even though there has been growth volume-wise in the market, we have seen increased payer pressure over the last year and it happens to be varied by geography as well. And our health economics teams are working with our field organization to help them navigate through that dynamic. But we remain excited about the addition of Acclarent to our portfolio.

是的，我們第二季的成長確實有所放緩，但這主要是由於去年同期的艱難競爭，我們的資本銷售強勁。我們看到，用於咽鼓管球囊擴張的 AERA 產品以及 TruDi 導航一次性產品均實現了強勁的兩位數成長。在球囊鼻竇成形術方面，儘管市場規模有所增長，但我們看到去年付款人的壓力增加，而且不同地區的情況也存在差異。我們的衛生經濟團隊正在與我們的現場組織合作，以幫助他們解決這個問題。但我們仍然對 Acclarent 加入我們的投資組合感到興奮。

We see huge opportunity for us. We're the only company that has a pediatric indication for the Eustachian Tube Balloon Dilation and we continue to invest in evidence for it, much like the announcement that you recently saw on the registry -- Pediatric Registry that we have launched. And when it comes to the second half of the year, our expectation is mid-single digit growth. And moving forward, again, we don't see any reason to be changing our outlook for this product -- for this business as we have had before. We're making investments in new products. We're making investments in clinical evidence and it's an important part of our portfolio.

我們看到了巨大的機會。我們是唯一一家擁有兒科適應症的耳咽管球囊擴張術的公司，我們將繼續投資於該技術的證據，就像您最近在登記處看到的公告——我們已經啟動的兒科登記處一樣。對於下半年，我們預計會實現中等個位數的成長。展望未來，我們再次認為沒有理由改變我們對這款產品的展望——就像我們之前對這項業務的展望一樣。我們正在對新產品進行投資。我們正在對臨床證據進行投資，這是我們投資組合的重要組成部分。

That's helpful. And then just one point of clarification. We saw a couple of recalls come in from the FDA during the quarter. I was just curious if these have been contemplated in guidance? And if not, if there's any impact you could call out, that would be great.

這很有幫助。然後只需澄清一點。本季度，我們看到 FDA 發布了數起召回通知。我只是好奇這些是否已在指導中考慮過？如果沒有，但如果您能指出其影響，那就太好了。

Yeah, happy to do so. So I think what you're referencing is a recall notice on MicroMyst and perforators. And those were products that we were aware of and had contemplated in our guide even as of May. So yes, that is not new news from a guidance perspective.

是的，很高興這麼做。所以我認為您所引用的是有關 MicroMyst 和穿孔器的召回通知。這些都是我們在五月就已​​經知道並且已經在指南中考慮過的產品。所以是的，從指導角度來看這並不是什麼新鮮事。

(Operator Instructions)

（操作員指示）

Richard Newitter, Truist.

Richard Newitter，Truist。

This is Ravi here for Rich. I guess a couple of questions for me here. First, can you kind of remind us as PriMatrix and SurgiMend, we're starting to look at them coming back in 2026. Can you just remind us what the revenue contribution from these products was or the growth contribution or the end market kind of contribution was before they went off market?

我是 Ravi，為 Rich 服務。我想這裡有幾個問題要我回答。首先，您能否提醒我們，PriMatrix 和 SurgiMend 預計會在 2026 年回歸。您能否提醒我們這些產品在退出市場之前對收入、成長或終端市場的貢獻是多少？

Certainly. So 2022 was the last full year before they went off market and they were about $64 million on an annual basis.

當然。因此，2022 年是它們退出市場前的最後一年，年銷售額約為 6,400 萬美元。

Great. And then as they went off market, I mean, was that entire kind of $54 million lost? Or were there products that you had in the portfolio replacing that? Just trying to get a sense in terms of the incrementality of what could potentially come back. Then I guess the second question is just on Acclarent. Is that something you're still having high single digit growth expectations for this year?

偉大的。然後當它們退出市場時，我的意思是，那 5400 萬美元就全部損失了嗎？或者你們的產品組合中有沒有可以取代它的產品？只是想了解可能回歸的增量。那我想第二個問題只是關於 Acclarent 的。您是否對今年仍抱持較高的個位數成長預期？

So with respect to PriMatrix and SurgiMend, when they -- we initially initiated the recall, there was a substitution strategy that allowed for potential growth on Integra Skin for PriMatrix and then Gentrix for SurgiMend. Given the -- some of the production issues that we had with Integra Skin, while you did say some initial uptake in terms of substitution, it wasn't significant. And then as it relates to Gentrix, similarly, the nature of the areas in which we could substitute was relatively narrow, so also not a significant amount of substitution or necessarily different either. As it relates to Acclarent, our expectations for full year 2025 is that that business will deliver or our ENT segment will deliver mid-single digit growth.

因此，就 PriMatrix 和 SurgiMend 而言，當我們最初發起召回時，有一個替代策略，允許 Integra Skin 取代 PriMatrix，然後 Gentrix 取代 SurgiMend 實現潛在成長。考慮到我們在使用 Integra Skin 時遇到的一些生產問題，雖然您確實說過在替代方面有一些初步的吸收，但並不重要。然後，就 Gentrix 而言，同樣，我們可以替代的領域的性質相對較窄，因此替代量也不大，也不一定有所不同。就 Acclarent 而言，我們對 2025 年全年的預期是，該業務或我們的 ENT 部門將實現中等個位數成長。

Okay. Great. And then just my last one, just on the tariffs. I think last quarter it was about $0.22 for the year. Kind of the way to think about it now with the kind of delta between last quarter and this quarter, just take that gross margin impact and that's going to be the new run rate?

好的。偉大的。最後我想問的是關稅問題。我認為上個季度全年數字約為 0.22 美元。現在想想，上個季度和本季之間的差異，只考慮毛利率的影響，這就是新的運行率嗎？

No. Let me step through that a bit because there are a couple of factors to consider. So to your point, in May, we had announced that the tariff assumption reflected in our guidance at that time was about $22 million or $0.22. Our current EPS outlook incorporates an anticipated headwind from tariffs totaling about $13 million or $0.13 with most of that impact expected to materialize in Q4. Beyond this year, though, we're not providing an estimate as obviously, we, like others, are watching an ever-changing tariff landscape.

不。讓我稍微解釋一下，因為有幾個因素需要考慮。正如您所說，我們在5月宣布，當時的業績指引中反映的關稅假設約為2,200萬美元，即每股收益0.22美元。我們目前的每股盈餘預期已包含預期的關稅負面影響，總額約為1,300萬美元，即每股收益0.13美元，預計大部分影響將在第四季顯現。不過，今年以後我們不會提供預估，因為顯然我們和其他人一樣，都在關注不斷變化的關稅狀況​​。

And so as that stops moving and we start understanding a little bit more the impact to our business, we'll come back and share expectations for any 2026 impact. That said, we are not standing still. As we mentioned in our remarks, we understand that optimizing our cost structure is essential to maintaining long-term competitiveness and the broader margin initiatives that Mojdeh talked about in her remarks will help us do just that.

因此，當這種情況停止發生並且我們開始更多地了解其對我們業務的影響時，我們將回來分享對 2026 年影響的預期。話雖如此，我們並沒有停滯不前。正如我們在評論中提到的，我們明白優化成本結構對於保持長期競爭力至關重要，而 Mojdeh 在她的評論中談到的更廣泛的利潤舉措將幫助我們做到這一點。

I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

我目前沒有其他問題。感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。