Integra LifeSciences Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 5, 2025
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Operator

Good day, and thank you for standing by. Welcome to the Integra Life Sciences first quarter two thousand twenty five financial results call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press 11 on your telephone.

Operator

You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. 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.

Christopher Ward
Christopher Ward
Senior Director of Investor Relations at Integra LifeSciences

Good morning, and thank you for joining the Integra Life Sciences' first quarter twenty twenty five earnings conference call. With me on the call are Moiz DePaul, President and Chief Executive Officer and Leah Knight, Chief Financial Officer. Earlier this morning, we issued a press release announcing our first quarter twenty twenty five 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 twenty twenty five Earnings Call Presentation. Before we begin, I want to remind you that many of the statements made during this call may be considered forward looking.

Christopher Ward
Christopher Ward
Senior Director of Investor Relations at Integra LifeSciences

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 inorganic revenue growth. Organic revenue growth excludes the effects of foreign currency, acquisitions and divestitures. Unless otherwise stated, all disaggregated and franchise level revenue growth rates are based performance. Lastly, our comments today will include certain non GAAP financial measures.

Christopher Ward
Christopher Ward
Senior Director of Investor Relations at Integra LifeSciences

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 eight ks filed today with the SEC. With that, I will now turn the call over to Moshe.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

Our year has started out largely as we expected. On our first quarter performance, revenue came in at $383,000,000 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 McLaren 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. Adjusted EPS for the quarter came in at $0.41 also within our guidance range.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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. 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 to be impressed by our team's strong commitment to our customers and our customers' consistent positive recognition of the value of our differentiated portfolio. I have also gained a more nuanced understanding of where organizational inefficiencies exist and where improvements are needed.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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 a portfolio prioritization strategy that clearly defines the role and expectations of each part of our portfolio within the enterprise. 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 and D. This alignment and focused execution is the underlying intent for our newly established transformation and program management office.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

Our future is an organization that is disciplined and unified behind successful execution of the highest, most impactful priorities for the enterprise. 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 prioritization and program management efforts must be driven holistically and in relation to one another rather than individually. We made important progress this quarter on the compliance master plan, particularly in plant level assessment and early stages of remediation.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

To date, from a site assessment standpoint, we've completed 10 of our manufacturing sites and remain on track to complete the remaining four sites by the end of third quarter. 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 remediations 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. As you may recall, during the Q4 earnings call, we reported we had identified approximately 27,000,000 in ship holds for the full year of 2025 related to the execution of the compliance master plan.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

We have made meaningful progress in addressing these holds 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 and $70,000,000, which we are working diligently to resolve. 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 products first. Our plan is guided to address gaps and findings related to quality system regulations, FDA warning letters, and form four eighty three observations.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

Based on the scope outlined in CMP, we are on track to complete the implementation of our actions outlined in the December warning letter by year end. In connection with PMA approvals, we are working diligently to resolve all warning letter observations 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 programs at the enterprise level and a more disciplined approach to program management and execution. 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.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

This office will lead efforts to instill a more rigorous enterprise wide program management discipline, ensuring programs are properly prioritized, scoped, and resource with clear milestones, KPIs, and oversight to ensure timely and complete execution. Rick Mavis 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 twenty years of experience, including leadership roles at three m and most recently at Solventon, he has a proven track record in business execution planning and program management. This capability will be foundational to how we operate going forward. 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.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

Valerie is a seasoned executive with extensive global operations and supply chain experience across health care, automotive, industrial, and consumer goods industry. 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 three m, 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 three m, experiencing firsthand her expertise in operation strategy, Lean Six Sigma, as well as driving continuous improvement in safety, quality, service, cost, and working capital. Valorant'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 deliver costs, and most importantly, delivering quality products to our customers.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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 Surgimen and Primetric. Our goal is to bring the facility online in the first half of twenty twenty six. We plan to provide a project status and launch time on update for the five ten k cleared products in q four of this year. 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 q one.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

However, we did deliver production and revenue performance in line with our q one expectations. A comprehensive set of Integra skin manufacturing resiliency programs initiated last year to improve yields, upgrade equipment, and optimize site utilization are beginning to pay off. We can see this already in Q2 and have experienced steady yield improvements for this product since Q4. We expect production and revenue run rates 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 $390,000,000 to $400,000,000 representing a reported decline of approximately minus 6.8% to minus 4.4% and includes, based on the recent exchange rate movements, an approximate 80 basis points tailwind versus the prior year due to foreign currency translation.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

We expect organic decline in the range of minus 7.5 to minus 5.1. As a reminder, we lapped the acquisition of Aclaren's on April 1, so Aclaren's revenue will be included in our organic growth metrics beginning in Q2. We are maintaining our full year revenue guidance of $1,650,000,000 to $1,720,000,000 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. We expect adjusted EPS for the second quarter to be in the range of zero four zero to zero four five dollars 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 tariff. While the tariff situation continues to rapidly evolve, we have incorporated the financial impact of tariffs into our updated 2025 guidance based on what we know today, which is obviously subject to change based on any future announcement.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

Most of our manufacturing takes place in The United States and Europe. Still, we source 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 on products manufactured in The US and exported into China, as well as tariffs on raw materials and components imported from China into The US. 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.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

In addition, we are carefully managing our expenses to help protect profitability. 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. Lia will now provide more specifics on the first quarter financial results and share additional details on our guidance and the impact of tariffs. Leah?

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Thank you, Moshe. Let's take

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

a more detailed look at our first quarter financial highlights, starting on slide five. Total revenues for the first quarter were approximately 383,000,000 representing growth of 3.7% on a reported basis and a decline of 3.5% on an organic basis compared to the same period last year. Reported revenues include approximately $29,000,000 from the Aclaren acquisition and a 60 basis point FX headwind. Organic revenue performance was negatively impacted by several supply disruptions provided for in our guide, including ship holds amounting to approximately 18,000,000, production timing impact to Integra Skin of about 9,000,000 stemming from a private label component supply issue. Our adjusted EPS for the quarter was 41¢, down 25% compared to 2024.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

As we look down the P and L, gross margins were 52.2% for the first quarter, down two twenty 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 two ninety 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 $11,300,000. Turning to slide six.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

We'll now discuss revenue highlights from our Codman Specialty Surgical segment. CSS reported first quarter revenues of $281,000,000 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. These holds particularly affected performance across our advanced energy, CSF management, dural access and repair, and neuro monitoring product line. However, demand across the neurosurgery portfolio remains strong, particularly in areas not affected by these holes.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

We were encouraged to see double digit growth in key products such as and Mayfield capital equipment. In our ENT business, we continue to be pleased with the progress of the Aclaren integration, which contributed approximately 29,000,000 in revenue for the quarter. Organic growth in our ENT 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 twelve months following the close of the Aclaren acquisition. First quarter capital sales declined by low single digits, primarily due to a tough prior year comparison from Ferrelink.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Excluding Ferrelink, 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 CSS declined by high single digits with the decline primarily attributable to the timing and duration of the ship hold. The resolution of these holds has taken longer in the international markets than in The US, limiting our ability to fulfill customer demand.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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. Moving to our tissue technology segment on slide seven. Tissue technologies revenues were 102,000,000, 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 chip holds on other products, which were implemented late in the first quarter. We continue to see double digit growth for DuraZorb and our UBM platform.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

In private label, sales were down 13% versus last year due to component supply delays. Finally, international sales and tissue technologies were down low double digits due to the forecasted production ramp up on Integra skin. Moving to slide eight, I will now review our balance sheet, capital structure and cash flow. During the first quarter, our operating cash flow was negative $11,300,000 and free cash flow was negative $40,200,000 reflecting higher capital expenditures as we continue to invest in key infrastructure. As of March 31, net debt was 1,600,000,000.0, and our consolidated total leverage ratio was 4.3 times within our current maximum allowable leverage ratio of five times.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

The current maximum allowable leverage ratio will remain at five through the third quarter of twenty twenty five, stepping down to 4.25 for q four of twenty twenty five. We ended the first quarter with total liquidity of 1,200,000,000.0, including 273,000,000 in cash and short term investments with the remaining liquidity available under our revolving credit facility. If you turn to slide nine, 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

We also believe it's helpful to quantify the specific effects and highlight the key drivers of the tariff in our lives. 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. 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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. We estimate an impact of approximately $22,000,000 in 2025 or 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 ninety day pause on July 9. The estimate also includes the new China specific tariff of 125% on US exports to China and a 45 on Chinese exports to The United States.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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 recognized 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. We expect a progressive impact to our gross margin and adjusted EPS across the final three quarters of twenty twenty five with an adjusted EPS impact in the second quarter of approximately 4¢.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Turning to our guidance for the second quarter of twenty twenty five, we expect revenues to be in the range of 390,000,000 to $400,000,000, representing a reported decline between minus 6.8% and minus 4.4%, and based on a recent exchange rate movement, includes an estimated 80 basis point tailwind versus the prior year from foreign currency translation. 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 25,000,000 in expected revenue impact from ship holds in the quarter related to execution of the compliance master plan. For the full year, we are reaffirming our revenue guidance in the range of 1,650,000,000.00 to $1,720,000,000.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

This forecast reflects sustained demand for our portfolio and remains consistent with our original guidance assumptions around the potential impact of ship holds. To date, cumulative full year revenue impact of identified ship holds is approximately 55 to 70,000,000. As a reminder, our full year guidance range contemplated between 90 and a hundred and $50,000,000 of ship holds associated with the compliance master plan. Our updated guidance also reflects an approximate $10,000,000 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 point 4% to 4.4.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Our 2025 revenue forecast assumes four primary drivers of sequential improvements throughout the year. First, we expect to benefit from typical seasonal volume increases. Second, we expect a moderating impact from the currently known ship holds 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Turning to adjusted earnings per share for the second quarter, we expect EPS to be in the range of 40 to 45¢, reflecting the effects of the ship holds, 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. 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 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Before we move to q and 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. With that, we'll now open the line for questions. Operator, please open the line.

Operator

As a reminder, if you'd like to ask a question at this time, please press 11 on your touch tone phone and wait for your name to be announced. Our first question comes from Matt Taylor with Jefferies.

Young Li
Young Li
Senior VP - Equity Research at Jefferies

All right, great. Thanks for taking our questions. This is actually Yelm Li in for Matt. I guess to start, maybe just on the two q guidance, you know, a little bit bigger than expected, but, you know, some of that is related to the shipment delay. Wanted to hear a little bit more about, you you know, what you found sort of late in one q for you to up that number even though it's within annual guidance.

Young Li
Young Li
Senior VP - Equity Research at Jefferies

And then just the assumptions for end 2Q guidance, and then just, you know, the confidence level for the second half of the year, given that it'll be a bigger ramp.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Certainly. Thank you for the question. So, to your point on Q2, it does reflect the newly identified the impact of the newly identified chip 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 shipwolves during the course of the year, right, 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

At the midpoint, the Q2 guide now reflects a step up of about $12,000,000 versus Q1, That reflects improved Entegra production, 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 $10,000,000 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 the second half of your question was with respect to the second half lift, from a second half perspective again at the midpoint, our guide reflects a step up of about $125,000,000 second half versus first half. Drivers of that are about 30% due to the combination of Entegra skin production continue 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 on that part of the business as well.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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 see about 15% of that lift driven by a net supply improvement, so while we did see supply 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.

Young Li
Young Li
Senior VP - Equity Research at Jefferies

Very good, very helpful. And then I guess to follow-up on a second question on tariff impact, You know, you called out 22,000,022 impact for '25. And just kind of wondering, you know, how much mitigation efforts are built into that? And then how should we do that number for 2026? Should we annualize it?

Young Li
Young Li
Senior VP - Equity Research at Jefferies

Will there be Thank

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

you for your question. So, we have several mitigations that we're pursuing when it comes to tariffs. You know, in the near term obviously we're continuing to apply for tariff exemptions and we're considering pricing, selective pricing increases as well as surcharges where appropriate and possible. 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 are building.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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. Leah, if you want to.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Yeah, let me take the second part of the question. So, to your point, the $22,000,000 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.

Young Li
Young Li
Senior VP - Equity Research at Jefferies

All right. Thank you very much.

Operator

Our next question comes from Ryan Zimmerman with BTIG.

Analyst

Hi, everyone. This is Izzy on for Ryan. Thanks for taking the questions. I heard your commentary on the expectation for private label to step up in the back half of the year, but

Analyst

I was just

Analyst

curious what kind of line of sight you have into demand and what is contributing to your confidence there.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Thank you for the question. Yes, we do anticipate a second half step up. The order of magnitude is about a $10,000,000 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 would get back to flat.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

That said, we still believe as this business moves forward into 2026, it will continue to perform at a mid single digit growth trajectory.

Analyst

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 in that line from tariffs.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

So, general, our instrument business tends to be lumpy, so we do have quarters to quarters where 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.

Analyst

Great. Thanks for taking the questions.

Operator

Our next question comes from Vik Chopra with Wells Fargo.

Vik Chopra
Vik Chopra
Analyst at Wells Fargo

Hey, good morning and thanks for taking the question. Moshe, you know, you've been there for, I guess, about a quarter, and I just love to hear kind of what has surprised you to the upside to the downside. And then I had

Vik Chopra
Vik Chopra
Analyst at Wells Fargo

a quick follow-up question, please.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

Hi, Vic. It's good to hear your voice. Yes, I 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 part of the challenges that we were facing, yes.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

That was not a surprise to me. The board had been very transparent with me about that. I think my findings 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 opportunity for significant improvement, 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.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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.

Vik Chopra
Vik Chopra
Analyst at Wells Fargo

Got it. Thank you. That's very insightful. My follow-up question is for Leah. You have a convert maturing in August of this year.

Vik Chopra
Vik Chopra
Analyst at Wells Fargo

Any thoughts on how you plan to satisfy that commitment? Thanks for taking the questions.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Thanks, Vic. Appreciate the question. Yes, 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

So that's how we'll manage that and we'll have that position through the end of twenty twenty seven. We'll then look to determine a more permanent financing structure in 2026.

Operator

Our next question comes from Robbie Marcus with JPMorgan.

Lilia-Celine Lozada
Lilia-Celine Lozada
Analyst at JP Morgan

Hi, this is actually Lily 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 $22,000,000 is from your exposure to China and how much of it is from Europe and other international import?

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

So let me answer that by giving you kind of a sense of how tariffs are showing up in the P and L, and I think that'll give you a sense of kind of relative sizing. So first, the cost associated with products manufactured outside The US and imported into The US, we capitalize that into inventory and we recognize that cost through the P and L and cost of goods sold, typically over a four to seven month kind of horizon. 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. In Q2, we're seeing about a $04 impact, which is largely China.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

As we progress throughout the balance of the year, you'll see more of that cost start to be reflected from the goods that we import into The US, but in the immediate it'll be more so China based.

Lilia-Celine Lozada
Lilia-Celine Lozada
Analyst at JP Morgan

Got it. And just as a follow-up on the guide, the 55,000,000 to $70,000,000 in ship holds is a pretty big step up from the $27,000,000 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

No worries. So, to your point, our guide that we communicated back in February did allow constructed with the intent to allow us to absorb about 90 to 150,000,000 in supply disruptions. Based on that and where we currently are, we could absorb an incremental 20,000,000 in supply disruptions for the balance of the year and still hit the high end of our guide. So the high end remains possible from us. 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 in demand that we're seeing from other parts of our portfolio that aren't impacted by supply.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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.

Lilia-Celine Lozada
Lilia-Celine Lozada
Analyst at JP Morgan

Great, thank you.

Operator

Our next question comes from Richard Newitter with Truist.

Ravi Misra
Ravi Misra
Associate Analyst - Medtech Equity Research at Truist Securities

Hi, good morning. This is Ravi for Rich. Thank you for taking the questions. I guess my first question, is around, some of the remediation commentary that you're talking about. Sounds like, Moshe, you put in some of the personnel that are needed to kind of take this to the finish line.

Ravi Misra
Ravi Misra
Associate Analyst - Medtech Equity Research at Truist Securities

But regarding the 2026 commentary around, you know, that can is 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?

Ravi Misra
Ravi Misra
Associate Analyst - Medtech Equity Research at Truist Securities

And then I have a follow-up.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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 four are going to be completed by the end of the third quarter. And then in the fourth quarter is where we're evaluating the findings as well as, strategizing with the remediation plans. And then also in Q4, we are doing the assessments in our key finished goods suppliers.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

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. 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. However, there's only certain parts of it that's in our control, 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.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

And we have been in regular dialogue with the FDA. 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 May. So we've been in dialogue with them working diligently to address, all the findings.

Ravi Misra
Ravi Misra
Associate Analyst - Medtech Equity Research at Truist Securities

Great, thank you. That was super helpful, commentary. And then I guess my second one is on skin substitutes and LCD push outs, 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, 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.

Mojdeh Poul
Mojdeh Poul
President & Chief Executive Officer at Integra LifeSciences

Sure, thank you for your question. Just a reminder that majority of our business is 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, we look forward to the implementation of it in January, hopefully.

Operator

Our next question comes from Joanne Wuensch with Citi.

Analyst

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 Braintree up by next year? Thanks.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Yeah, Anthony, thanks for the question. So to your point, again, we are in the process of implementing those tariff 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 CNP or those remediation efforts. 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 and incremental to C and P measures without conflict.

Operator

Our next question comes from Jason Bedford with Raymond James.

Jayson Bedford
Jayson Bedford
Managing Director - Medical Technology at Raymond James Financial

Good morning. Just a couple of questions that probably require quick answers. I think they're all for Leah. First, on the 22,000,000 in tariffs, is it fair to say that half of the impact is China if I just carry the $04 through the year?

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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

Jayson Bedford
Jayson Bedford
Managing Director - Medical Technology at Raymond James Financial

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

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

No, not based on what we see right now.

Jayson Bedford
Jayson Bedford
Managing Director - Medical Technology at Raymond James Financial

Okay. And then last one, is there a 2Q revenue impact from skin and private label component? Apologize if I missed it earlier.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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, we'll still not see the lift in Q2. That lift will begin in Q3.

Jayson Bedford
Jayson Bedford
Managing Director - Medical Technology at Raymond James Financial

Thank you.

Operator

Our next question comes from the line of Craig Bijou with Bank of America.

Craig Bijou
Equity Research Analyst at Bank of America Securities

Good morning. Thanks for taking the questions. A couple of follow ups for me. Lee, 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 $10,000,000 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?

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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 to 43. So, if you recall in our February call, at that point in time we had identified annual impacts of about 27,000,000, 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 fifty five to seventy million is what we're currently projecting as the annual impact for ship holds. So, I hope that answers that part of the question. And then, your second question, Craig, or the

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

second part of your Yeah,

Craig Bijou
Equity Research Analyst at Bank of America Securities

organic growth. Think in the bridge, goes from three to 2.4. So, is that just the ship hold impact?

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

Yes, so we held the reported range of our February guide flat, and it does reflect a $10,000,000 tailwind from FX that was absorbed into organic piece.

Craig Bijou
Equity Research Analyst at Bank of America Securities

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

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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

Craig Bijou
Equity Research Analyst at Bank of America Securities

Okay, and then one quick follow-up. On your debt leverage, 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.

Lea Knight
Lea Knight
Executive VP & CFO at Integra LifeSciences

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, 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.

Craig Bijou
Equity Research Analyst at Bank of America Securities

Great, thanks for taking the questions.

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.

Executives
    • Christopher Ward
      Christopher Ward
      Senior Director of Investor Relations
    • Mojdeh Poul
      Mojdeh Poul
      President & Chief Executive Officer
    • Lea Knight
      Lea Knight
      Executive VP & CFO
Analysts
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Key Takeaways

  • In Q1, revenue of $383M was at the top end of guidance, with reported growth of 3.7% but organic revenue declining 3.5% due to ship holds and supply constraints, and adjusted EPS of $0.41.
  • The Compliance Master Plan has completed assessments at 10 of 14 manufacturing sites, with total 2025 ship holds now expected to be $55–70M (up from $27M) and most remediations targeted by year-end 2025.
  • A new Transformation and Program Management Office has been established to embed disciplined execution across operations, quality, and R&D, led by Rick Mavis, alongside a new Global Supply Chain VP, Valerie Young.
  • Recently announced global tariffs are estimated to cost ~$22M in 2025 (22¢ per share), with mitigation strategies including sourcing optimization, pricing actions, and pursuing exemptions.
  • For Q2, revenue guidance is $390–400M (reported decline of 6.8% to 4.4%; organic decline of 7.5% to 5.1%) and EPS of $0.40–0.45, while full-year revenue is reaffirmed at $1.65–1.72B with EPS of $2.19–2.29.
AI Generated. May Contain Errors.
Earnings Conference Call
Integra LifeSciences Q1 2025
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