Earnings Labs

Integra LifeSciences Holdings Corporation (IART)

Q4 2023 Earnings Call· Wed, Feb 28, 2024

$10.70

+0.05%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-4.55%

1 Week

-6.62%

1 Month

-12.34%

vs S&P

-15.48%

Transcript

Operator

Operator

Good day, and thank you for standing by. Welcome to the Integra LifeSciences Fourth Quarter 2023 Financial Results. [Operator Instructions] Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Chris Ward, Senior Director of Investor Relations. Please go ahead.

Christopher Ward

Analyst

Good morning, and thank you for joining the Integra LifeSciences Fourth Quarter 2023 Earnings Conference Call. Joining me on the call this morning are Jan De Witte, President and Chief Executive Officer; Lea Knight, Chief Financial Officer; Mathieu Aussermeier, Senior Vice President of Corporate Finance, Investor Relations and Treasurer. This morning, we issued a press release announcing our fourth quarter 2023 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 a file named Fourth Quarter 2023 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. 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 reporting an organic revenue growth and organic revenue growth, excluding Boston. For 2023 results, organic revenue growth excludes the effects of foreign currency, acquisitions, divestitures and discontinued products. For 2024 guidance and reporting, organic revenue growth will no longer exclude discontinued products. Organic revenue growth, excluding Boston excludes the revenues from products manufactured in our Boston facility in both periods. Management believes that excluding revenue from all products manufactured at the Boston plant provides useful information when evaluating the company's organic growth because of the unusual nature of the manufacturing stoppage and voluntary global recall. Unless otherwise stated, all disaggregated and franchise-level growth rates are based on organic performance. Lastly, our comments today will include certain non-GAAP financial measures. Reconciliations of the 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 with the SEC. And with that, I will now turn the call over to Jan.

Jan De Witte

Analyst

Thank you, Chris, and good morning, everyone. Before we dive into our financial results, I first want to acknowledge the commitment of our teams working to strengthen our operational capabilities, while capitalizing on the growth of our markets and building out our strategic potential. Total sales for the fourth quarter were $397 million, representing a year-over-year organic decline of 1.2%, or growth of 3.6% if we exclude the Boston products. Our fourth quarter adjusted earnings per share were $0.89. Both results were within our guidance at the low end of the range. For the full year, sales were $1.54 billion, flat on an organic basis and up 5.5%, excluding Boston, with full year adjusted EPS of $3.10 per share, and Lea will take us deeper into these financials in a few minutes. So let's turn to slide number four to cover an update on Boston and our strategic highlights for the year. Although the Boston recall weighed on our financial results for the year, we're pleased with the significant and steady progress we have made towards bringing the Boston portfolio back on the market by mid to late second quarter. We restarted the factory in November. And in January, we successfully completed an initial external review following the factory restart, the dress rehearsal we referred to in earlier calls. We're now preparing for the external audit, which will take place in March. Successful audit will allow us to start building finished goods inventory to resume distribution mid to late second quarter. When we look at the broader performance of our business, excluding Boston, we are encouraged by our results and resilience of our markets and the strength of our broad portfolio. Full year growth in Codman Specialty Surgical and Tissue Technologies was approximately 5% and 7%, respectively, in line with…

Lea Knight

Analyst

Thanks, Jan. We'll move on to our full year financial results, starting with slide five. Two primary themes characterize our financial results for 2023. First, we have seen a full recovery in our markets and growth in line with our mid-single-digit growth expectation. There is strong demand for our broad and diverse portfolio of products, with several parts of our business growing by double digits, and we continue to make investments that will deliver value to shareholders. The second theme was the impact of the Boston recall, which drove significant operational challenges in 2023. Our full year revenues were $1.542 billion, down approximately 1% on a reported basis, with organic growth flat for the year and within our guidance range communicated in October. The Boston recall represented an approximate $67 million headwind to our reported revenues. Excluding Boston, organic growth across the remainder of our business was approximately 5.5%, demonstrating the continued robustness of our diverse portfolio and the markets that we serve. We delivered double-digit growth across many product lines in our portfolio. In CSS, we saw double-digit growth in CUSA Clarity disposables, Certas Programmable Valves, DuraGen, Mayfield Capital, BactiSeal, CerebroFlo EVD catheters and ICP microsensors. Our specialty surgical instruments saw double-digit growth in our Jarit and MicroFrance ENT products. In Tissue Technologies, we delivered double-digit growth in DuraSorb, Gentrix and MediHoney. Our adjusted EPS for the year was $3.10, down 7.7% versus 2022 and within the guidance range communicated in October. The Boston recall negatively impacted full year adjusted EPS by approximately $0.42, including the impact of spending reductions we implemented during the year. Looking at the middle of the P&L, our gross margins were 66.1% for the year, down 110 basis points versus 2022. The Boston recall impacted gross margins by approximately 150 basis points due to…

Jan De Witte

Analyst

Thank you, Lea. Please turn to Slide 12 to conclude our prepared remarks. Looking back at 2023, we saw our unique technologies and commercial strength deliver resilient growth across several parts of our portfolio. However, this achievement was obscured by the Boston recall. Organic growth, excluding the impact from Boston, which landed at 5.5% for the year, continues to give us confidence in the growth potential of our markets and our portfolio. Although the recall has required a significant amount of our team's focus and attention, we are confident we will bring this part of our portfolio back to our customers and their patients in mid to late second quarter. We remain committed to delivering reliable long-term business performance, consistently executing our commercial and operational plans and building our capabilities to achieve profitable growth. We have strengthened our quality management system with critical investments in talent and process capabilities across our manufacturing network. We're also making investments across our manufacturing plants and supply chain to ensure reliable supply for our commercial teams, our customers and their patients. In parallel, we launched projects to realize our operational efficiency opportunities and achieve sustainable margin expansion. We also continued building out our new product development capabilities and remain focused on leveraging organic and inorganic projects to drive improved business performance. We're executing our implant-based breast reconstruction strategy, progressing the Aurora minimally invasive neurosurgery platform and preparing to launch the BactiSeal-Endexo combo catheter. We continue to expand our international portfolio and commercial capabilities. And the work to close the Acclarent acquisition by second quarter remains on track, and we look forward to welcoming the Acclarent team to Integra. As we strengthen our operational resilience, advance our organic portfolio and successfully execute on our M&A imports we're well positioned to deliver strong top and bottom…

Operator

Operator

[Operator Instructions] Our first question comes from Vik Chopra with Wells Fargo. Your line is open.

Vik Chopra

Analyst

Hey good morning and thanks for taking the question. Jan, I just want to congratulate you on your retirement, and I'm sure we will all miss working with you. So it sounds like it's a personal decision. I just wanted to see if you could shed some additional color into that. And then I had a follow-up question, please.

Jan De Witte

Analyst

Yes. Thank you, Vik, for your question. Yes, it's a personal decision driven by family requirements. It's a decision that I discussed with the Board over the past several weeks and given -- I wanted to make a decision early to allow all of us to manage a very smooth transition over the year, okay, my main concern is to make sure that we execute our 2024 plan, keep on track with our short and our longer-term strategic objectives.

Vik Chopra

Analyst

Great. And just as a follow-up. So I think the Q1 guidance was obviously well below expectations. Can you maybe highlight some of the puts and takes and what gets you to the top versus the bottom end of the guidance range and how confident you are in resolving the supply backlog issue starting in Q2? Thank you.

Lea Knight

Analyst

Thank you, Vik. Appreciate the question. So a couple of dynamics, right? As we look at kind of Q1 and the organic growth outside of Boston, that's where we're seeing the impact as a result of the Integra Skin supply constraint that I talked about in our Q4 results as well. And so just kind of a bit of background on that, we did have an issue that impacted the throughput on one of our production lines for Integra Skin. That's resulting in the supply constraint that I mentioned. It first appeared kind of in that or -- yes, appeared in the December time frame and continued into early Q1. We've since resolved that supply constraint and are starting to rebuild inventory. But as you can imagine, it's going to take us a while to catch up to kind of the demand. And so that's impacting the growth that we would have anticipated in our portfolio outside of Boston. The other dynamic that I would call out is related to our CUSA Clarity. As I mentioned, what we saw in Q4 is we're in the later stages of our refresh cycle on CUSA Clarity. And so the rate of growth is slowing on that -- for that part of the business. So that's an element. But also in Q1 of 2023, we had a fairly big comp. We had some pretty large buy-ins for CUSA Clarity in Q1 a year ago that we're now comping, that is also impacting kind of the overall growth rate for the quarter. And then I think -- so those are the elements that are impacting kind of base growth outside of Boston. Obviously, we also are lapping $15 million of a comp of having Boston revenue in a year ago, not in the first quarter of 2024. And so those are kind of the key elements. I think just to follow on, and I think you asked kind of as we progress throughout the year in terms of supply, getting back into full supply, because we now are in a position of resolving the supply constraints, rebuilding our inventories, we would anticipate, as we move into Q2, that we are, from a growth perspective, getting back into the mid-single-digit growth expectations for the business. And then certainly, as we bring Boston portfolio back online and get to the back half of the year, that's when we would -- might see kind of even stronger mid-single-digit growth for the balance of the year. So we do believe that you'll start to see that turnaround in Q2.

Operator

Operator

Thank you. One moment for our next question. Our next question comes from Kristen Stewart with CL King. Your line is open.

Kristen Stewart

Analyst · CL King. Your line is open.

Hi, thanks for taking my questions. I was wondering if we could just discuss a little bit more in detail the gross margin and just thinking about the cadence of when you guys think you can get back to a more normalized gross margin and what you kind of see that as.

Lea Knight

Analyst · CL King. Your line is open.

Yes, certainly. So -- and I'll talk about it through the lens of kind of -- I'll start first on kind of full year 2023. So on a full year basis, gross margins were down 110 basis points. And as I mentioned, a big driver of that is due to the Boston recall. As we move forward into 2024, we are anticipating a modest improvement in gross margins. So we'll start to see some of the benefit come back as we bring the Boston portfolio back online. We won't see the full benefit, and we won't see the full benefit for a couple of reasons. One, the Boston portfolio will only be back in for 2024 for a portion of the year. So that higher gross margin portfolio, again, we won't see the full benefit. Two, from a remediation cost perspective, which is part of the reason why we were down in 2023, we're still incurring remediation costs until we're fully up and running. And so while that should be less in 2024, it's still going to be a factor. And I think the other dimension is from some of the supply constraints on Integra Skin, it is also creating a headwind for our gross margins. So net-net, we are starting to see some of the benefit come back from Boston. We won't realize the full benefit, and that's why we're calling a modest improvement. That said though, Kristen, that I think to your point, we are not waiting for the Boston portfolio to come back to drive overall gross margin improvement. We are actively adding additional resources to launch projects in 2024 aimed at extracting the value that we've talked about that exists in terms of improving our margins through better operational efficiency as well as yield and productivity improvements. And so that work is also very much underway. And so we'd expect to see the benefits from that work, along with the benefit from the full Boston portfolio coming back online as we move into 2025.

Kristen Stewart

Analyst · CL King. Your line is open.

Thank you. And just a quick refresh on the Acclarent acquisition. I know that's not in your guidance now, but do you still feel comfortable that, that's going to be neutral to 2024?

Lea Knight

Analyst · CL King. Your line is open.

Yes, yes. That was kind of what we shared at the time that we announced the acquisition. We are working diligently to close that. Still anticipate planning to close it by Q2. And at this point still project that it will be EPS neutral in 2024.

Kristen Stewart

Analyst · CL King. Your line is open.

Okay, perfect. Thank you for taking my questions.

Operator

Operator

One moment for our next question. Our next question comes from Ryan Zimmerman with BTIG. Your line is open.

Ryan Zimmerman

Analyst · BTIG. Your line is open.

Good morning, thanks for taking my question. Maybe just to start, you do expect to close Acclarent in -- at the end of 2Q. Is that right? And I just want to ask that because -- sorry, go ahead.

Lea Knight

Analyst · BTIG. Your line is open.

By Q2. Yes, by Q2, Ryan.

Ryan Zimmerman

Analyst · BTIG. Your line is open.

Okay. So I mean, I recognize that we're not including Acclarent guidance for current estimates. But just to be clear and just to ground everyone, we should expect something in the range of maybe $50 million to $60 million in sales in the back half of the year in organic sales that is on Acclarent, just based on kind of their current run rate and profile. Or are you expecting anything different just because of that integration?

Lea Knight

Analyst · BTIG. Your line is open.

Yes. So we're not providing guidance right now on what Acclarent will do to our overall call at this point. I think what we have shared is revenue based on that business in J&J's hands as of 2022 was in the order of magnitude of $110 million in revenue. So obviously, depending on when we actually complete the acquisition, we'll have a partial year. And so...

Ryan Zimmerman

Analyst · BTIG. Your line is open.

All right. Well, we'll put something in there for it. I assume you'll get it closed. Maybe just turning to Tissue for a moment. I mean, I recognize that you guys have faced tremendous challenges, and I think everyone in the Street recognizes that. When Tissue comes back, though, implied in your guidance, net of Acclarent and so forth, is a sizable ramp in the back half of 2024 on Tissue products. And so I appreciate some color on why that happens and why it's not more gradual and why -- it's a pretty competitive environment. I mean, people are probably seizing on the opportunity. And so just help us understand kind of your thinking around the back half of 2024 in terms of the recovery in Tissue.

Jan De Witte

Analyst · BTIG. Your line is open.

So let me take that one. I mean, first, a big part of that ramp is linked with Boston getting back on -- our sales force is looking forward to that and are ready to take the projects when they are up and running. They feel good about winning our customers back. Two factors playing there. One, the relationship has been maintained over the past 9 months, plus given the breadth of our portfolio, our sales force is still with our customers, serving them with other products. In terms of getting the product back, I mean, this is an area where customers now and then do trial other products, and so they have no issue switching back. We know that our products out of the Boston factory are differentiated, differentiated from a strength, the size, conformability, price perspective. Our sales force feels strongly they can win their customers back based on the strength of that portfolio.

Ryan Zimmerman

Analyst · BTIG. Your line is open.

Okay. Let me just sneak one more in, and I'll hop back in queue real quick. Just because -- China has been a growth area. We know that China VBP, particularly in neurosurgery, has been an area of focus. Can you just talk about what's happening in China, the impact of pricing on your neuro business within China and when your China-for-China strategy can take hold?

Jan De Witte

Analyst · BTIG. Your line is open.

So on China, the big driver behind our China success is that, one, this is a big growing market where we are geographically and from a penetration in hospitals, we're still have plenty of opportunity to further penetrate. And so that's what we're doing from perspective of strengthening our sales capability. That's also the backdrop to our in-China-for-China strategy to be seen as a more local player doing high level or late-stage assembly there. That factory by the end of this year should start to produce products for product qualifications. So somewhere near the end of 2025, we should be feeding part of the products for that market out of our local factory. And so this is a dynamic, the China opportunity that, as we look at new hospital builds, new geographies, it's a continuation over the next years of going after that opportunity. From a VBP perspective, we've seen limited impact. Our products are differentiated, a limit number of local players, plus it's not a massive market where we play. Therefore, not as much on the radar screen for the VBP pressure.

Ryan Zimmerman

Analyst · BTIG. Your line is open.

Thank you.

Operator

Operator

One moment for our next question. Our next question comes from Jayson Bedford with Raymond James. Your line is open.

Jayson Bedford

Analyst · Raymond James. Your line is open.

Good morning. Thanks for taking the questions. Just a couple for me. I think there's a lot of moving parts here, but it does look like you pulled back on your assumptions for the contribution from the Boston facility in 2024 relative to last call. I think on the call today, you made a comment referring to only including SurgiMend and PriMatrix. Why the change, if I am correct here?

Lea Knight

Analyst · Raymond James. Your line is open.

Yes. Thank you, Jayson. And yes, you are correct. So our guidance right now reflects SurgiMend and PriMatrix, which is pretty much the majority -- which is our commercial business out of Boston. What we've excluded from the guidance for now is the private label business. And so that describes why the tailwind that you may have been expecting is lower in our guidance. And so let me kind of step back and explain why. At this -- as you know, we've been partnering with our private label partners throughout to keep them apprised of our time lines, progress on the remediation and have given them access to kind of assess the progress we're making at our manufacturing site in Boston. But at this point, we are not producing salable finished goods yet, and we don't have orders from our private label partners. And so we have not included it in guidance, but anticipate that as we get closer to our commercial relaunch, we have an opportunity to update this kind of audience and our guide as appropriate based on what transpires between now and then. And I would expect that timing to be in and around our Q1 earnings call.

Jayson Bedford

Analyst · Raymond James. Your line is open.

Okay. But to date, there hasn't been any private label relationships that have been severed. Is that fair?

Jan De Witte

Analyst · Raymond James. Your line is open.

I would say that's fair to say. We are continuing to discuss. We know that our private label customers are evaluating their different options that they have in terms of deciding on final option. I think that will happen the moment where we really get into commercial shipping, and both they and us have more certainty on what's coming out and when.

Jayson Bedford

Analyst · Raymond James. Your line is open.

Okay. Just one quickie, I apologize if I missed it. What's the expectation for the first quarter gross margin?

Lea Knight

Analyst · Raymond James. Your line is open.

We did not provide gross margin guidance for the quarter, just for the year and I think kind of a modest improvement, 2024 over 2023.

Jayson Bedford

Analyst · Raymond James. Your line is open.

Okay, thank you.

Operator

Operator

One moment for our next question. Our next question comes from Robbie Marcus with JPMorgan. Your line is open.

Robert Marcus

Analyst · JPMorgan. Your line is open.

Great. Thanks for taking the questions. And Jan, I'll add as well, sorry to see you go. Wish you all the best. Maybe a couple of questions again on the guide just to help clarify because there are a lot of moving pieces here. Maybe if you start with first quarter and the full year, and you look at sell-side numbers and you look at your current expectations, what do you think are the biggest deltas between it? Because the EPS came in fairly materially lower as did first quarter, particularly. So what are you assuming for the supply constraint headwind in first quarter? And where do you really see the biggest delta versus sell-side numbers right now?

Lea Knight

Analyst · JPMorgan. Your line is open.

So let me break that down into a couple of pieces. Again, from a first quarter perspective -- and actually, let me start from kind of how we ended 2023. So on a full year basis, the portfolio outside of Boston grew in that mid-single-digit range that we said is kind of the right place for this business, right? So as you move into 2024, I think that becomes the starting point of what this business has the potential to do. What we're seeing in Q1, as I mentioned earlier, was the impact of the supply constraints. There's also the impact of the kind of CUSA Clarity dynamic that I mentioned for Q1. That's lowering the growth rate that we're experiencing on the business outside of Boston. And so that kind of describes why we have a lower start to the year. As we move into Q2 and we resolve the supply constraint, we get back into mid-single -- sorry, yes, mid-single-digit growth on the business and continue through the balance of the year, that's when we'll really see the business operating back at the levels that we were operating in, in 2023. So I would say the largest kind of deviation between what you were anticipating and what you're seeing on a revenue top line basis has to do with that. Clearly, there is a profitability implication because the nature of the gross margin on skin are definitely kind of higher gross margin products in our portfolio, so that is a contributor to why there is likely a gap from an EPS perspective. And then the final thing I'd mention, as we are bringing Boston back up online, we are returning to more normal OpEx levels probably about a quarter sooner than we had originally anticipated. We see the Boston relaunch as an opportunity to take an aggressive kind of marketing, advertising approach to getting back into the market with our products. And so that is feeling kind of becoming -- operating at more normal levels prior to what we really anticipated.

Robert Marcus

Analyst · JPMorgan. Your line is open.

Great. Maybe just as a follow-up on free cash flow. You guys did about a 40% conversion rate in 2023. There were a lot of exclusions that lowered the cash flow. How should we be thinking about cash flow in 2024 here and not just the full year, but also the progression through the year? And if I could just squeeze one more. On the last question, you talked about the difference between the prior commitment of what products and you're leaving out private label. I believe before, it was a 100% run rate of sales within 12 months. Now excluding the private label, do you know what that percentage of sales is? Thanks.

Lea Knight

Analyst · JPMorgan. Your line is open.

Let me deal with the cash flow question first. To your point, cash -- free cash flow for the quarter in 2023 was about $34 million. Our free cash flow conversion rate on a trailing 12-month basis was 29.5%. As we move into 2024, we do -- we'll have to overcome some of the headwinds that I've talked about in Q1, which will actually drive our trailing 12-month conversion down slightly. So think of it being kind of in the low 20s. And then as we progress through the year, we resolve the supply constraint on Integra, we relaunch Boston, we start to comp, some of the lower growth period that we saw in 2023, specifically in Q4, that's when we would expect our trailing 12-month to get back up to about 58% by the end of the year. So it's a progression up, with Q1 being kind of the low point and then improving every quarter thereafter. So that's the cash flow. I think your other question was with respect to how to think about the Boston business through the lens of how long it's going to take us to get the Boston business back, right, now that we've removed private label. There is actually no -- yes, there is no change to that thinking because, again, previously, when we've talked about our relaunch and talked about regaining kind of our run rate trajectory, it was through the lens of the commercial business, right? And so that's kind of the frame that we've talked about. And we still anticipate, while we think there's a slightly longer ramp initially for -- in terms of the 2024 impact, as we get into 2025 and we have all products relaunched out of Boston, that's when we think in kind of that Q3 time frame is when we'll be back at the run rate we left it at in 2022.

Robert Marcus

Analyst · JPMorgan. Your line is open.

Appreciate it. Thank you very much.

Operator

Operator

One moment for our next question. Our next question comes from Ron Feiner with Oppenheimer. Your line is open.

Steven Lichtman

Analyst · Oppenheimer. Your line is open.

This is Steve Lichtman. Jan, I was wondering if you could provide some more color coming out of the external review in Boston, what some of the learnings there, why that gives you confidence on the resumption of sales starting in the second quarter.

Jan De Witte

Analyst · Oppenheimer. Your line is open.

So on Boston, just as a reminder, we restarted that factory in November and then in January had an external review, which we call the dress rehearsal. I call it a successful dress rehearsal because what we got were the confirmations, but also the learnings that we hoped to get based on the work done and its guidance, the learnings have been guiding us since the end of January over February into the preparation for that external audit, which will take place in March. The audits pretty much cover every aspect of our quality management system, I mean, from beginning to end. We got, I would say, limited observations on things that we could have improved. The main learnings, in fact, were on how people were conducting the interactions with the different auditors. And that's why we called it a dress rehearsal. Part of successful audit is not just having your quality management system processes documentation where it needs to be. It's also making sure that in the question and answering with the auditors, you make sure that all that work is readily visible. So overall, like I said, since end of January, we're now, let's say, finishing on the lessons learned and preparing pretty much in a straight line to that external audit, which will start the first week of March.

Steven Lichtman

Analyst · Oppenheimer. Your line is open.

Got it. Great. And then what are you assuming with regard to incremental CereLink sales in 2024 with the 510(k) and CE mark in hand now? And can you remind us of that opportunity through over the medium to long term now that it's back on the market?

Lea Knight

Analyst · Oppenheimer. Your line is open.

Yes. Thank you for the question. So CereLink, as you saw, we did achieve a clearance in the U.S. in early February. And so we are relaunching that in the U.S. market. Because of timing of when we got the clearance, we're assuming about 10 months of U.S. sales in our guide. And so just as a reminder, on an annual basis, what we've said is the monitors are about $12 million globally. And so a portion and the U.S. market being the largest market. So hopefully, it's enough to dimensionalize kind of what the 2024 implication is. In terms of that business going forward, I think, annually, we would expect monitor sales to be in and around that same level, with the real opportunity being on the disposables that we'd be able to sell through as a result of increasing our installed base for the monitors. And in past experience, we've seen that business grow at about kind of high single, low double digit, and we would expect similar performance here.

Jan De Witte

Analyst · Oppenheimer. Your line is open.

Maybe just one addition to that, looking over the next couple of years, because you've seen when we talk about strategies, CereLink is one of those multiyear global growth catalyst. I think we've learned during the recall that this is a great product. Customers that we had stayed with us because they like the microsensors and were willing to wait for CereLink to come back. Prospects that we had before the recall also waited because CereLink is pretty much the most innovative product in the market. And so we see our sales force now picking up those leads and those prospects that they had before. We're at this point focused on U.S. and Europe. CereLink will be launched in probably 2-plus years in Asia, with China being another important market for CereLink at that point.

Steven Lichtman

Analyst · Oppenheimer. Your line is open.

Got it. Thank you.

Operator

Operator

One moment for our next question. The next question comes from Richard Newitter with Truist Securities. Your line is open.

Richard Newitter

Analyst · Truist Securities. Your line is open.

Hi, thanks for taking the questions. Maybe just going back to Kristen's gross margin question. I think you had suggested that by first half 2025, gross margin should be more normalized. First, did I hear that correctly? And then, I guess, just looking beyond second half 2024, is there any reason that you wouldn't be back to historical levels, say, 2022 margin levels? And then I have a follow-up.

Lea Knight

Analyst · Truist Securities. Your line is open.

Yes, certainly. So -- and just to be clear, we are not providing guidance with respect to 2025. So our data guidance is that we would expect a modest improvement in gross margin in 2024 over 2023. For 2025, again, as we bring the full product portfolio back online for Boston, we'd expect some of the headwinds that we saw in 2023 to reverse, right, especially from a mix perspective. So that's the improvement that I was referencing. On top of that, there are these additional projects that I mentioned that we're launching in 2024 to extract additional value out of our supply chain and operational efficiency that should also contribute to gross margin improvement in 2025 over 2024. But at this point, we would not dimensionalize exactly how much that value would be. We have more work to do before we're in a position to determine that. And we got a follow-on...

Richard Newitter

Analyst · Truist Securities. Your line is open.

I'm sorry. Go ahead.

Lea Knight

Analyst · Truist Securities. Your line is open.

I thought there was a second part to your question.

Richard Newitter

Analyst · Truist Securities. Your line is open.

Yes, yes. Sorry. Yes. So just one on CUSA. Is that all just comps year-over-year? Or are there competitive pressures potentially to be considering as well? And does that mean that growth snaps back in the back half on easier comps? And then also just if you -- I'm not sure if I have heard. Did you indicate whether or not you -- or timing of FDA PMA inspection for SurgiMend? Thank you.

Lea Knight

Analyst · Truist Securities. Your line is open.

So I'll take the CUSA comp question, and then I'll let Jan respond on the SurgiMend. From a CUSA perspective, so in Q1, yes, what we are seeing are much more difficult comps based on what happened in Q1 2023, and that is the primary driver. There is -- because we are in the later stages of our refresh cycle, the growth rates do naturally slow as a result of that. And so that's a contributing factor as well. Again, it doesn't impact the size of our installed base. That is still growing. It's just growing at a lower rate than what we've seen previously.

Jan De Witte

Analyst · Truist Securities. Your line is open.

Okay. On the SurgiMend inspection, so the pre-approval inspection, we still expect that to happen in the second half of this year in light of getting PMA in 2025 for SurgiMend.

Richard Newitter

Analyst · Truist Securities. Your line is open.

Thank you.

Operator

Operator

One moment for our next question. Our next question comes from Craig Bijou with BofA Securities. Your line is open.

Craig Bijou

Analyst · BofA Securities. Your line is open.

Good morning. Thanks for taking the question. So I wanted to go back to the Boston impact and just kind of what you guys are assuming for the second half SurgiMend and PriMatrix. I mean, if I look at the numbers, including the Q1 impact and then the full year impact, it looks like it may be $25 million or so in the second half -- of about $25 million of revenue in the second half. So I wanted to see if that was right. And then if I remember correctly, the Boston products were run rating a little bit over $80 million, I think, as of -- in 2022. So wanted to know what piece or what percentage of that was private label. I think you've talked about that in the past.

Lea Knight

Analyst · BofA Securities. Your line is open.

Yes, yes. So -- and so let me back up and just frame out. So you're right. The business in Boston, we size it about kind of 5% of our total business, which is roughly the $80 million. Within that, the private label piece is about 20%, and commercial business is about 80%, right? When we first talked about the potential impact in 2024 as a result of Boston, we frame that out as a $50 million impact. So off of an $80 million starting point, you get to an expectation that for 2024, we'll be about $30 million. But that -- and the guidance we're providing now takes out of that the private label piece, which is why our guidance in terms of the tailwind that Boston is providing in 2024 is 60 basis points versus what should have been closer to or could have been closer to 150 to 200 basis points.

Craig Bijou

Analyst · BofA Securities. Your line is open.

Got it. Thanks. That's helpful. And then on Codman, so understand and appreciate the color that you're giving with CUSA and the comps and where you are in that replacement -- or the placement cycle. How should we think about Codman growth in 2024? Is it going to be at the lower end given some of the dynamics, the lower end of your LRP, that 3% to 5%, I believe?

Lea Knight

Analyst · BofA Securities. Your line is open.

Yes. So Codman actually had really strong growth. And again, if I could just step back and look at 2023. On a full year basis, our growth across that division was 4.8%, which is actually at the higher end of the range that we anticipate for that business. And as we continue into 2024, we'll continue to see that business operate in that strong mid-single-digit sort of area. And so, yes, definitely don't anticipate any kind of slowing down, if you will, for that part of our business.

Craig Bijou

Analyst · BofA Securities. Your line is open.

Great. Thanks for taking the questions.

Operator

Operator

One moment for our next question. Our next question comes from Dave Turkaly with Citizens JMP. Your line is open.

David Turkaly

Analyst · Citizens JMP. Your line is open.

Hi, good morning. I think, last quarter, we talked about expecting sort of a 10% to 15% replacement rate maybe for the products that were off. And I was just curious, based on the comments and maybe even on Skin, are you running a little bit below that? Or any update you can give us there?

Jan De Witte

Analyst · Citizens JMP. Your line is open.

Yes. That replacement rate is still around that range definitely in the wounds. And yes, it's one of the factors that drove a strong Skin demand and why our inventories over that -- the past several quarters have further depleted, a bit more vulnerable to some yield effects on the line. Yes. Overall, that replacement was in that range.

David Turkaly

Analyst · Citizens JMP. Your line is open.

And then maybe for Lea, appreciate the headwinds in 1Q. But if you look at the Skin supply and then CUSA -- and I was wondering if you might rank them or quantify them maybe in terms of that revenue and/or the EPS impact do you think they're going to have in that first quarter, again, recognizing that EPS number was certainly the most impacted.

Lea Knight

Analyst · Citizens JMP. Your line is open.

Yes. So I think if I had dimensionalize for you the impact, the Skin impact is probably the larger determinant for why, on a Q1 basis, our growth outside of Boston is not what we would anticipate in terms of single-digit growth, with CUSA Clarity being kind of the next element. And again, part -- a big part of that being the comp.

David Turkaly

Analyst · Citizens JMP. Your line is open.

Great. Thanks.

Operator

Operator

One moment for our next question. Our last question comes from Joanne Wuensch with Citi. Your line is open.

Joanne Wuensch

Analyst

Thank you very much for taking the question. And Jan, congratulations on retirement. I'm just sort of curious, as you go about the search what you're thinking the next CEO should bring to the table and what he or she may do differently. And then I'll toss my second question in now. There was commentary during the call about it sounds like you're refocused or an increased focus on international opportunities. Can you sort of frame that and how you think about funding it and the time frame to accelerating it? Thank you.

Jan De Witte

Analyst

So on the CEO succession, like we communicated, I mean, the Board has put a search committee in place. We're working with Heidrick & Struggles to do a thorough and deliberate search to find a CEO successor that. On the one hand, it comes with proven track record of driving profitable growth businesses and, at the same time, further building out a high-performing organization. From a strategy perspective, I mean, the strategy that we've been driving over the past couple of years, the strategy that we built with the executive leadership team and our Board going after commercial acceleration with new product development, digital, building out our position in the care pathways, both organic and inorganic and driving international, that strategy remains intact. And my focus this year with the leadership team is making sure not just to deliver the 2024 plan, but also further drive that momentum behind that strategy. And expectation is that we'll continue in that direction. In terms of international, we had a great international year. It is one of the strategic levers, and it will remain one of the strategic levers where we can further drive our penetration and commercial execution, not just in China, but in the breadth of international countries outside the U.S.

Joanne Wuensch

Analyst

Thank you.

Operator

Operator

Thank you. Ladies and gentlemen, this does conclude today's presentation for today. You may now disconnect, and have a wonderful day.