Integra LifeSciences Holdings Corporation (IART) Earnings Call Transcript & Summary

All right. Good afternoon, everybody. Thanks so much for joining us. Matt O'Brien. I cover medical technology here at Piper Sandler. I'm very fortunate to have Integra with us here. From the company is Jan, who is the CEO, and then a couple of folks from IR are out in the audience. So thanks so much for coming out. I really do appreciate it.

Great to be here, Matt.

Excellent. So maybe start a little bit with Q3. It was a little bit better than you expected, a little more stable than I think a lot of folks, I guess, generally, were expecting for Medtech. So what did you see in Q3? And then the early days of Q4 that, prior to the earnings call, what were you seeing from your end markets?

Yes. One, we're, I mean, happy with the markets that we see, right? And that's both in our neuro parts as well as our tissue technologies, including international. So yes, market is there. We get confirmation. Our product portfolio is as distinctive as we like to think it is. We are winning where we want to win. And we've got our commercial team focused on getting the most out of the market's potential. So it has led in the third quarter. If you exclude for a minute the impact of Boston to growth numbers, 5 or above, which we see as a benchmark and an indicator for where we want to be with our long-range planning. Of course, Boston is keeping us -- is busy, it's obscuring some of those numbers. But we remain laser focused on executing the remediation, staying on track there. While, in parallel, we continue to focus also on the several new product initiatives and growth initiatives that we have, and that really are strong pillars under the business for the next LRP period to come.

Okay. And then the Boston recall did take some folks by surprise in Q3. It seemed like it had a bigger impact than expected. There was more of a return provision that I think some of us were expecting. Can you just talk a little bit about what dynamic hit you there that you weren't expecting? And then just the customer attrition and your ability to hold on to those customers eventually?

Yes. So 2 questions. First, on the recall, which, in the essence, was a misestimate based on limited information in the month of June, July when we called a recall. Yes, I had to give guidance -- I want to give guidance on what we assumed would be called back. At that point in time, we did have pretty much no visibility to what do our customers have on the shelf, okay, in their books. And so we made a number of assumptions that, based on some of the bigger customers where we do have access, made sense. It's only in the month of August, September, October when our sales force started to work with customers to call the products back and document what's there that we start to see that, specifically on the smaller customers that had more inventory in months of supply than what we had assumed. And that's where the 7 million surprise pretty much came from. It's the smaller, where we misestimated what they had on their shelves.

And you're still comfortable with that 7 million, that's the number that there's -- it's not going to creep higher if you had those?

Yes, because that number was made with pretty much full insight now on what's on the shelf. Because this is based on discussions that our sales reps had with the other customers.

Okay. And then how have the customers responded to the recall? Is it -- I mean recalls happen in Medtech. This isn't surprising. Have they been reasonable as far as their frustration levels? Or is that something that could be a headwind for you guys as you head into next year?

I would say reasonable as it comes with frustration level. It's credit to our sales force, the relationships that they've built, the credibility that the Integra brand has in the market. And like you said, customers know that this will happen now and then. The fewer, the better. We've put our effort in making sure that, with our customers, we help them through this tough period. We put them in as smooth as we can, okay? What we've done internally to accomplish that is, one, make sure that we protect our sales force. Our sales force is a major relationship linked to the customers. We've made sure in their compensation, how we incentivize them, that we gave them some protection, at the same time, incentivize them for working the substitution products. In Integra, we have the benefit of not being a one-trick pony. We have a broad portfolio, both for SurgiMend as well as for PriMatrix. There's other Integra products that could be good substitutes. So our sales force has worked with customers to -- where we could substitute. And we're confirming that 10% to 15% of sales revenue which will come back to other products. The other parts where we can't substitute is going to other players. We're now at talks with our sales force. And the more information and -- they get as they continue working with customers is that they feel good about getting that business back. And pretty much for the same reasons that we got the business in the first place, which is the products, SurgiMend and PriMatrix, are really exceptional in what it brings to the patients from a perspective of strength, uniformity, conformity, ability to deliver bigger sizes and at price points which are competitive to the alternatives. And so as we recalled the product, okay, the discussions with our customers became interesting because they told us why they wanted to keep that product. They essentially made a sales pitch for us, which we're going to be using as we get back into the market, why they like SurgiMend, why they like PriMatrix. And so today, okay, we plan based on those insight. And from the moment where we get back into the market to when we get our revenue level back where we were before, it's going to be about 12 months to get back to that. And that's, again, based on what we learned from customers and based also on what we learned from some cases in the past.

Okay. How confident are you in the progress we're making on the Boston manufacturing side and getting back to the point where you're able to manufacture as much as you need?

Yes, it's a tough question, right? Because I can't tell you what you want, it's -- but what's behind my confidence, okay? There's -- yes, what definitely has made me confident is that along the path, at several points in time, we brought in external auditors to assess the progress we're making, both from a perspective of are we forgetting anything? And second, what we're doing, does it meet the standard that FDA or any other auditor will hold us against? And so that, for me, is the major factor of, hey, I feel good with the progress we make, but I also feel good with the quality of the process we're making. As some of you may remember, when we had the earnings call in October, okay, we put a couple of milestones down, okay, to measure or to communicate that progress. The first one was this first phase from June, July until October, where we made a holistic plan, leveraged all the inputs, feedbacks we've gotten from FDA and other auditors and internal. Made a plan, progressed well on that plan, and kicked our own tires along the way to make sure we -- so then we said, okay, the next big step is to turn the factory back up. Very important because remediating your quality management system, there's a lot of people work. It's upgrading your process description, upgrading your design history files and so on. A lot of paperwork, but then the reality still has to happen. So turning on the factory is important for fine-tuning, for validating processes, validating product and starting to train or retrain our operators in the factory, okay? So we said we want to do that before the end of the year. In essence, we turned on the factory a bit more than 2 weeks ago already, okay? So I'm happy with the fact that we're creating additional time for us to iterate, to drive improvement, to double check, triple check on the different changes we make and creating more time to ramp up our operators back in a factory that hasn't been running for pretty much 9 months now. So then the next phase is going to be in the first quarter, okay, where, as part of the plan and agreed with the FDA, we will have a external auditor do an end-to-end audit for us, commissioned by us, okay, on a positive outcome, which we drive for. We communicated to the FDA, at that point in time, we can go commercial, okay, which would mean we start first building inventory, enough inventory to have a smooth commercial house. Yes, be back in the market mid-second quarter and second quarter. So that's another important milestone, say, end of Q1. Part of what we're doing in the beginning of Q1, probably January, early Feb, is a bit of a dress rehearsal. So we're bringing in another auditor to do an end-to-end audit of the facility, okay? The last time to kick all tires, just to make sure that there's nothing that we may have forgotten. And so it's that process that gives me confidence that we're not making only progress, we're checking. We're checking the quality of the process from a perspective of does it meet the standard that external regulators will put on us.

Yes. Okay. So it sounds like everything is in pretty good shape as those things go. I mean finger's crossed it's [ not something ] whatever you want to call it.

I'll be paranoid until we get the products in the market.

Got it. Okay. Okay. And then where can your customers go, from a competitive perspective, for a SurgiMend or a PriMatrix? And why are you confident you can get those [ booked ]?

Yes. So for SurgiMend, at least part of that business is in the breast reconstruction market. It's a $600 million big market, attractive market, but dominated by one player who has more than 90% share in that market. Now we were growing faster than the market before the recall. So we were taking share. That share that we've taken, in many cases, goes back to the incumbents. Our sales force feels confident that the volume will come back for the same reason that customers came to us in the first place, okay, which is the qualities of the product, the strength, the size, conformity and step change, lower price level. So that's a clear area on where to focus. PriMatrix, which is about room reconstruction, that's a more fragmented competitive space. So volume is going to different players. One thing that we have learned during the recall is that the product is probably better than we ourselves thought, based on why customers really didn't want to give it up. And so that insight will help us to further dimension how and where we plan the relaunch of PriMatrix.

Let's move on to other areas of the business that are perking up nicely, although I do want to talk about China for a minute. But CereLink, that has relaunched in certain international markets. Just love to hear about how that's going there and then the domestic relaunch and thoughts there.

Yes. So CereLink relaunched in first international countries end of September, it was. Over the fourth quarter, one country after another, based on their regulatory pathway, we're getting them back. We should be, by the end of the fourth quarter, be back in all international markets where we had CereLink. Good experience with the customers. You may remember, when we had a recall, we had the insight that, for the surgeon, it was important to be able to maintain working with the Microsensor, the feel, the rigidity. And remember, Microsensor is what the surgeon will put in your brain. So they want something that they know how it's going to bend in and react. And so as part of the recall, we ensured that we brought the earlier product, ICP EXPRESS, off the shelf and made it available again to our customers. So we solved their issue. They could continue to work the way they wanted to work. Today, we see, as we're back in the market, that customers have been waiting for CereLink to come back. And we have seen very little returns of CereLink. So customers like the product, and given, at the time, to wait for CereLink, which is a step change better product than anything else in the market. So that's the dynamic we see in international. With existing customers, we start to see competitive wins again, where we take out competitive [ sockets ] in international. We expect the same to happen in U.S. There, the 510(k) got submitted at the end of the third quarter. It's a normal 510(k), not a special. So we fall into the normal time lines, which point us to getting back in the market somewhere in the first quarter next year.

Okay. Excellent. Best of luck with that. And then on the China anticorruption topic of conversation right now. Can you just maybe remind us your percentage of sales that comes out of China? And then how impactful is everything that's going on over there to your business?

Yes. So China volume is about 6% of our top line kind of growth. Yes, it's more important than that 6%. So China is an important opportunity for us. From a government action in anticorruption, I think, like everybody, in the month of August, they were like a certain freeze because nobody knew what was happening. So nobody dared to do anything. Government in September took more time to explain what they were trying to accomplish. That had created a bit of normality back. We've seen September relatively little impact. No material impact in October and after. Now part of that is explained by the type of business we're in, okay? We're essentially -- it's a neurosurgery business in China, which are very much procedure-driven. As a doctor, the judgment calls and what technology you're going to use are kind of limited. And there's also limited opportunity for overuse or abuse of, right? You're only going to use 1 sensor, not 2. So that makes it a kind of a more predictable type of area, where the risk for doctors to make choices is lower than in other parts of health care, where there's bigger money at stake. So that has helped us in not seeing too much of an impact. In addition, we are building out China with U.S.-based standards. So from a perspective of how we set up our education events, how we remunerate KOLs that come in and speak and educate, that's all following the processes that we have here, which are the right ones. And essentially, that's what China wants to happen. But we don't need to change our own process there. I'm not disrupting my own sales force in China because I got them where they need to be from a compliance perspective.

Okay. Okay. Good to hear. As far as the breast recon PMA goes, I'm trying to remember off the top of my head, which is not good, but just where that stands, especially with the Boston facility? And then can -- you can't progress ahead with that PMA until the manufacturing facility is back up and running. Is that right?

That's right. So there's 2 parts to the PMA, right? There's the clinical part, clinical study, and then there's the manufacturing certification to declare your manufacturing is certified for PMA products. On the clinical side, we submitted in July the last pieces of data that the FDA wanted to have. So that's kind of -- that data is in. The critical part is now getting the certification of the Boston plant, okay? Before that to happen, the Boston plan needs to be up and running. It needs to be back in the market, yes? Then we will probably invite the FDA to come and audit. Hopefully, in the fourth quarter of 2004 -- at '24, if not in the first quarter of 2025 for that PMA audits. To then get this PMA, we aim for the first half of '25.

Okay. How big a deal do you think the PMA is going to be in terms of transitioning market share to SurgiMend because you have that big provider that's been there for a long time and people have used forever?

Tough to see what kind of further acceleration it would give, right? So today, with SurgiMend, which is -- let's make a choice based on the capabilities for soft tissue reinforcement. We can't commercialize specifically for breast. But that is -- alone resulted already in growing faster than the market. When we will have the PMA, we will be ahead of competition. And the question is how much? Is it, 1 year, 2 years, more? So we can actually really educate customers on the benefits of SurgiMend as compared to alternatives. So yes, we expect a significant impact. At the same time, we're also going for PMA with our DuraSorb resorbable synthetic, which, I would say, is 1 year behind SurgiMend. So we're aiming for a position where, during a certain time, we're the only one with 2 PMA products in the market that have complementarity. And that, for our sales force, will be a fantastic situation to offer that choice and capability with a PMA label to surgeons. So we're really focused that time and whatever advance we have, we aim to make the moves out of that advance.

Got it. Okay. All right. Well, fingers crossed there as well. What about on the top line side of things? Again, things are steady in Q3. I think The Street is modeling you like kind of 4%, 5% top line growth next year. That's kind of in line with the LRP that you laid out at the Analyst Day. Is that what we should continue to expect on the top line from Integra?

So this year, if you look year-to-date, apart from Boston, we're above the 5%. So our core starts to show numbers that start to point towards those LRP expectations. Now with Boston coming back next year, there's going to be some year-over-year that may probably make the number look a bit higher than that. But overall, and that's why we keep communicating around our core, we started to see the 5% to 7% growth expectation into the core of our products. And so we'll definitely make our plans. I depends on what we see the market and our capability to deliver to that market.

Okay. Is there going to be a scenario where the 5% to 7% over the LRP period, but when you get SurgiMend and PMA approval and DuraSorb as well, I mean, could there be a stretch where you're at the high end of that range or even higher for a little bit, just given the opportunity for that product?

Yes, it's too early to give kind of further guidance on LRP, right? I think at this point in time, we try to get beyond the disruption that Boston gets in every number, every protection. Yes, at that point in time, we'll, both on growth, but also our margin evolution, start updating that trajectory and those end points.

Yes. Well, that was the next question because of -- I'm assuming those are higher-margin products. So just talking about the mix shift that you could see from those products as well as CereLink and then Aurora, et cetera, going forward, how can mix benefit you guys going forward?

Well, most of the -- whether you talk CereLink, whether you talk our breast, all of them is mix accretive, right? There's other NPIs, new product introductions that are coming. Aurora, we'll get full commercial now with Aurora. Yes, there's -- probably end of next year, there's the combo catheter, the products that come. So all of these should be products that are margin accretive and growth accretive to the business. That's where we pointed them and why we prioritize them for.

Got it. Okay. And then just lastly, last couple of minutes here, just on the M&A side of things. I think you ended Q3 at about 3x levered. That's the bottom end of the range you typically operate in. Are you open for business as far as M&A goes? Or hey, let's get through Boston first and then hopefully revisit it?

It's a mix of those 2 answers. We're -- one, we have a strong balance sheet, and we have a good financial rigor. And M&A remains a key lever of our strategy, growth in tissue tech as well as in CSS. Tissue tech. Okay, there, we made a decision until we got Boston back. Yes, we got a lot on our hands, leadership focus on Boston. On the CSS side, the Codman side, looking at opportunities, we may be, at this point, a bit less aggressive than we typically would be if Boston would be back. At the same time, we know strategic targets that we would like to have in the portfolio. Sometimes, we can't control the timing, okay? So between now and Boston, if something happens, yes, it would be on the CSS side with deals that are clear strategic adjacencies or tuck-ins.

Okay. Still smaller, though, most likely than some that are a little more bulkier? And then does the interest rate environment kind of change your view as far as what you'd be interested in?

Not too much impact of the interest rates. Yes, there's definitely -- I mean, this is not the time to do something that's really big, transformational.

Are there areas of CSS that are growthy areas? Because I know Tissue Tech is a faster growth area for you guys.

So the answer is yes, right? And part of how we filter in our game board is what are the growth-accretive segments, okay? And which, at the same time, has synergistic capabilities, technology or channel, so we can drive value and not just growth acceleration.

Okay. Well, as I look at the clock here, we're out of time, so I have to go ahead and end it there. Jan, thanks so much for all feedback. Appreciate it.

Thanks for the opportunity.

You bet.