Good day, and welcome to the Integra LifeSciences Second Quarter 2021 Financial Results Call. Today's call is being recorded. At this time, I'd like to turn the call over to Mike Beaulieu, Director of Investor Relations. Please go ahead..

Thank you, Stephanie. Good morning, and thank you for joining the Integra LifeSciences Second Quarter 2021 Earnings Conference Call. Joining me on the call are Peter Arduini, President and Chief Executive Officer; Glenn Coleman, Chief Operating Officer; and Carrie Anderson, Chief Financial Officer..

Thank you, Mike, and good morning, everyone. I'm pleased to report strong results this morning, reflecting the continued momentum in the business, which enabled us to raise our full year guidance. If you'll turn to Slide 5 in the deck, I'll begin with a review of our second quarter performance.

Total revenues were $390 million, representing reported growth of 51% and organic growth of 49% compared to the prior year. Our growth rates were above the high end of the guidance we provided in April and represent organic growth of approximately 3.7% compared to 2019.

The gradual recovery in our business, coupled with growth acceleration in products launched over the last 18 months drove much of our strong performance in the second quarter. Sales were particularly robust across a vast majority of our franchises in both segments.

Sales of capital equipment and products in some of our indirect markets are still early in their recovery and showing encouraging trends. Based on feedback from our commercial teams, we expect year-over-year improvement in the second half, especially with respect to capital.

Profitability was also very strong in the second quarter with EBITDA margins of nearly 26% and adjusted earnings per share of $0.79. Higher revenue, favorable mix and integration savings drove much of our performance, offset somewhat by normalization of our expenses..

Thanks, Pete. Good morning, everyone. Please turn to Slide 8. As Pete indicated, our second quarter operating performance was better than expected. I'd like to highlight a few of the factors that contributed to our results and some of the progress we made during the quarter, including an update to the catalyst we discussed at our May Investor Day.

Our performance in the second quarter sequentially increased $30 million or 8%. It was led by a recovery in our core portfolio of products in neurosurgery, instruments, burn trauma and surgical reconstruction..

Thanks, Glenn, and good morning, everyone. I'd like to start with a summary of our second quarter highlights on Slide 10. Second quarter total revenues were $390 million, representing an increase of 51% on a reported basis and 49% on an organic basis compared to the prior year.

Compared to 2019, organic growth was 3.7% in the quarter and was broad-based, including positive organic growth in both segments as well as in both our U.S. and international markets. Revenues were approximately $12 million above the high end of the guidance range.

Adjusted gross margins in the second quarter was 68.1%, an improvement of 190 basis points compared to 2020 and an improvement of 70 basis points compared to 2019. These gains were driven by a better-than-expected recovery in our revenues and favorable U.S. product mix, including the addition of ACell.

Our Q2 adjusted gross margins came in slightly better than expectations. But as mentioned on our Q1 earnings call, our adjusted gross margins in the first half were impacted by higher manufacturing costs related to tight labor supply. We are also experiencing longer lead times for select sourced materials, resulting in some increases in freight.

These labor and supply chain challenges will likely persist into the second half, and will keep us near the lower end of our full year adjusted gross margin range of 68.2% to 68.5% that was provided during our Investor Day meeting. Consistent with this outlook, though, second half adjusted gross margin should be modestly higher than the first half.

We are closely watching material cost inflation and have supply contracts to largely reduce near-term exposure..

Thanks, Carrie. If you turn to Slide 15, I'd like to summarize a few of the takeaways. Our first half performance in COVID recovery were very strong. And when coupled with our outlook for the second half, gives us confidence to raise our full year outlook on both the top and bottom line.

We'd all hope that the pandemic would be completely behind us as we begin the second half of the year. But it's now clear that the lingering effects are going to be with us globally for the coming months.

That said, we're seeing very healthy recovery trends across all our businesses and geographies, and we remain optimistic about a strong second half of the year and full recovery in 2022. Our teams are adopting to a hybrid environment.

And while we're returning to more in-person meetings, we'll continue to leverage all the digital tools that we've implemented over the last 16 months.

In the second quarter, growth in many parts of our business exceeded pre-pandemic levels, our new products will drive growth in '21 and beyond, and we believe many of these products in both neuro and regenerative tissue business represent breakthrough technologies that will deliver better patient outcomes through innovative therapeutic advances.

We look forward to the launches of CereLink, our neuro critical care monitor and the Aurora scope, a first product from our minimally invasive surgical platform. Each of these products raises the bar in their respective markets and advances our leadership position within neurosurgery. For the second half of the year, we remain focused on execution.

We've sharpened our strategy and put in place the operational capabilities and leadership team to drive faster growth and greater value for shareholders in '21 and into the future. So that concludes our prepared remarks. Thanks for listening. And operator, if you wouldn't mind, please open up the lines for questions..

Our first question comes from Steve Lichtman with Oppenheimer & Company..

I guess first question I wanted to touch on with CereLink with the launch pending here in 3Q. Can you give us a sense of what the outlook on the rollout is you've talked in the past about a lot of potential targets out there of both old Codman systems and competitive systems.

How are you seeing CereLink potentially contributing to growth in the second half and then into 2022?.

Steve, it's Glenn. I'll start off and maybe just first highlight some of the differentiating features of CereLink and why we're excited about it. First, it's more accurate than other products that are on the market as less microsensor drift. It's MR compatible. The sensor durability and flexibility is the best on the market.

So it doesn't have kinking or bending because you can coil it, you can tunnel it and surgeons really like that capability. And then it's got this advanced data presentation, which -- think of it as a waveform on the actual product versus point-in-time reading. So you can measure ICP burden over time.

And measuring that pressure and having some historical data can really inform clinical decisions, which is an important part of this new product rollout. And keep in mind, why we are excited about it in addition to those features is we have the largest neuro sales force that's going to be rolling this out.

So in terms of the launch itself, we're going to do a controlled market release here in the third quarter, both in the U.S. and a handful of sites outside the U.S. So don't expect a lot of revenue in the third quarter associated with the controlled market release. We expect to then pivot though to a full market release in the fourth quarter.

We do have some pent-up demand, so we should see a nice uptick in revenues in the fourth quarter once we move to a full market release. What I really like about this product, though, is we talk about hitting peak year sales 3 to 5 years out. And that's probably where we'll be in the U.S. market in 2025 or 2026.

The nice thing is, though, we're going to then be launching in China around that same time frame, which will drive additional growth for really the next 10 years when we look at CereLink.

So we see a real nice path here for a number of years relative to CereLink, the growth it's going to bring to us, not just on the upfront capital purchase but also the disposable side of this as well. So Hopefully, that gives you some color on how we're seeing it. But there's probably something close to 9,000 units out there that we could replace.

Almost half of those are in China. So that's why we're excited about the longer-term aspects of not just the next 3 to 5 years, but the next 10 years, we have a real big opportunity here to upgrade the installed base and take the market share from others that are in the market today..

I think it's fair to say as well, I mean, both our existing installed base and most of the competitive installed base is over 10 years old. I mean some of these items are out 15 to 18. And so there's clearly a need I think a lot of you know that this idea of cerebral pressure, brain swelling is one of the most critical metrics.

And so having the features Glenn talked about is a pretty big deal. So we're excited about what this can represent really over the next 3 or 5 years..

Got it. Great. And then just secondly, with the higher sales performance in the first half and the EBITDA coming in higher, that's translated, as Carrie mentioned, on to cash.

Do you anticipate the use of cash in terms of M&A to pick up again here in the coming quarters with -- are you comfortable now with the leverage ratio where we could see some more tuck-in M&A on the technology side?.

Yes. I think, Steve, you're right on in terms of understanding that we've got a lot of flexibility on the balance sheet now with -- our target leverage window is usually 2.5 to 3.5, and we're at 2.4x now. So really good flexibility to give us to be opportunistic on M&A. I'll let Glenn talk about some of the areas that we're focused on, on that side.

But M&A has always prominently been part of our capital allocation strategy. We want to continue to be opportunistic in M&A and certainly can support that with the balance sheet.

Glenn?.

It's great to see the performance of the cash flows of the business over the past 6 months to 9 months and Carrie and team have done a real nice job. And that does provide a lot of flexibility. And we take a balanced approach to it.

So what I mean by that is what investments are needed to fuel growth in the actual core business, including the catalyst that I walked through in some of my prepared remarks. And then, obviously, M&A is a big part of that as well. As we talked about during the Investor Day, acquisitions and integrations are a core competency for us as a company.

And so as we look at the M&A landscape right now, we're focused on doing tuck-in acquisitions. I'd love to be able to get a couple done before the end of the year, but we'll have to see how that plays out. We're looking at adjacent opportunities in neurosurgery along with our regenerative business.

And then still looking at international partnerships, so not necessarily going on acquiring technologies, but licensing deals where we can leverage our large commercial channels in places like Japan and China, to name two. But listen, we're going to remain very disciplined on M&A.

We've got great cash flows, as we talked about during our prepared remarks. We've got a number of things that are in the pipeline. But expectations around valuations are quite high right now. So we'll have to see how some of that plays out. But we're in a really good position from a balance sheet and flexibility point of view..

Our next question comes from Dave Turkaly with JMP Securities..

Just to start with, you mentioned ACell and I think you highlighted sort of restricted access in terms of the delta of the $13 million or so that we're looking for, for the year now.

And I'm just curious, is that -- should we think of it as like headcount turnover some as well? I know there's a lot going on in the biologics space, but when you say that, are you talking about duplicative folks? Or how should we just kind of think about that specifically? Is it they can't get in or is it that there's going to be fewer reps?.

Dave, it's Glenn. Let me take a shot at this one. So I think, first off, ACell is a great asset, and it has a really nice synergistic fit into our overall business. In terms of the integration itself, all the integration activities are on or ahead of schedule. All the functional areas are really running well.

So think of that as 2 plants that we inherited, quality organization, distribution, all the back office functions, that's all going really well. So let me take you back to the beginning of the year. And one of the key assumptions that we had was we had to do a sales force integration in order to get this business to be profitable.

As a stand-alone business, this was not a profitable business. And I would just tell you that, that sales force integration has actually gone really well.

The short-term challenge that we're facing is as our reps are handing off the relationships and selling these new products, it's been more difficult to get face-to-face in-person selling versus a virtual environment.

I think as we start to see more and more access being lived and getting access into the hospital theater, that's going to really help to get the momentum we need for the ACell business. But it's been a challenge because we have had restricted access. And the good news is month-to-month, we are seeing improvement. Having said that, the sales will come.

The sales growth will happen. And so we feel quite confident around the ACell business, like I mentioned before, it's a great fit. And one of the nice things and positives around this is also the fact that it's enabled us to have new conversations with our existing portfolio and complex wound and surgical reconstruction.

And you saw that performance in our base business in the current quarter. If you just look at our U.S. sales performance, we grew over 20% in our PRS or plastic and reconstructive business, mid-single-digit growth in wound reconstruction in the U.S. And so getting some positive benefits in the base business as well.

So Carrie, I don't know if you want to add anything to it..

Yes. I would just say the way I look at it is everything that Glenn mentioned, but from a guidance perspective, I look at we derisk the second half. we had a slower start in ACell. The guidance reflects an improvement from the second quarter, but a slower ramp for the rest of the year.

It doesn't change my outlook for 2022 and hitting our accretion target. So everything is on track there. But we derisk the second half. And because of the fact that the rest of the business, the organic base of the business is really performing really quite nicely. So when you think about guidance, we took guidance up by $15 million.

ACell came off a little bit, but the underlying base organic business was up $28 million to $29 million embedded in that guidance..

Great. I guess as a follow-up, neuro and instruments, your Codman side has been really strong and kind of always thought of those as sort of lagging. But as you sort of look at the performance, some of the things you called out, CSF, dural access.

I mean, do you think these markets are accelerating or is it your portfolio? Or I guess just any thoughts around some of the strength there..

Yes. In Q1, those were -- certainly, the neuro side of the business was a little weak. And it was mainly due to some of the surgeries that we saw in the wintertime and went in with storms in February. So a little bit weaker on the procedure side of the business.

And our expectation was the second quarter, we would see some improvement in the neuro side of the business, the procedure-based pieces of the business, which we absolutely did. We saw that in burn and trauma and surgical reconstruction as well.

And then instruments, particularly in the doctor office side of the instrument side, saw some nice lift as well. Whether that's deferrals or pent-up demand, it's really hard to know for sure, but I'm sure there was a piece of that, that we benefited in the second quarter but ultimately saw some nice recovery.

And we think it bodes well for the second half of the year. Dave, there are parts of the business that are still not at 100%, like capital, like our indirect markets. And so as we move into the second half, I think and move to more -- getting everything on all cylinders, I think it bodes well for a strong second half..

Dave, I would just add, keep in mind, in 2019, we've launched a number of new products coming out of the Codman portfolio that have a multiyear ramp to them and then COVID hit. And so we never saw the benefit of that first, second year ramp which we're starting to see now.

So in addition to these procedures coming back, we look at our CSF portfolio, a number of the Certas valve enhancements that we rolled out, the toolkit, our surgical headlamp, DuraGen in Japan, all these products are really gaining momentum now that we're coming out of COVID.

And so that's another driver of what you're seeing in terms of the stellar performance in our neurosurgery business..

Our next question comes from Kaila Krum with Truist Securities..

Great. So I guess just at the midpoint of your third quarter guidance, I mean you're assuming a step down from Q2. And to me, that makes sense because of traditional seasonality that you're also effectively assuming that Q3 is only up about 2% relative to the third quarter of 2019.

And I think your goal is to -- or has been to grow the business higher than that.

So can you just walk me through sort of how you're thinking about your guidance specific to the third quarter and just some of the puts and takes there?.

Yes, Kaila, I'll take that one. And I think you're thinking about it exactly correct. If you look at historical patterns of seasonality, typically, Q2 to Q3 is about flattish. Because there's European holidays, U.S. holiday, summer vacations that happen, and that's kind of comprehended within our guidance there.

In addition, again, I do think that we benefited from some deferrals of pent-up demand in the second quarter as it relates to some of the performance, as I responded to Dave's question. And so as you normalize that, you kind of get to that flattish type of Q3 number.

And I would say at the low end of our guidance, we are -- do comprehend some variability related to recovery as it relates to continuing delta variant impacts potentially. The variability and the vaccination rates.

And at the same time, we did take down ACell a little bit within those numbers, which implies a 6% organic growth compared to 2020 on the base business. So we think Q3 is set up nicely and certainly, the trends that we've seen thus far would support that. And -- but overall, I think you've got -- you're thinking about it correct, Kaila..

Okay. Great. That makes sense. And then you guys are lifting guidance for the full year. But as you've mentioned, you're cutting the ACell contribution. The base business is doing a lot better than expected.

But I mean, what is it that is performing so much better than you guys had expected in the organic business? And then gives you confidence that you can recover those lost revenues in ACell over the next sort of 12 to 18 months?.

Yes. So relative to the full year guidance numbers and why we are confident in our base business, we're really seeing it across the board in our disposables businesses. So outside of capital, we've seen really good strength in our nerve repair business. We've seen good strength in our CSF Management business. Instruments has come back very nicely.

And on the tissue side of the business, we're seeing some really strong growth, both on the wound reconstruction side as well as our PRS side. So I would just say, in general, all those areas are doing quite well.

The 2 laggards are still the indirect markets piece that Carrie mentioned in capital, which both are actually showing positive trends, but are still not where we'd like them to be in terms of a normal spending environment.

Pete, I don't know if you want to add anything to that?.

Yes. I would just think on the neuro bigger picture side, if you remember the charts Carrie showed, I mean, last year about where it fits on the scale of elective versus emergent. It's obviously one of the first-in-line emergents.

If you look at our 2 businesses, the first sales reps that really could get back into the hospital in the OR by far was our neuro team because those procedures had some level of pent-up necessity. Obviously, people only have a certain time to wait on many of these procedures. And.

Then as things opened up, TBIs or traumatic brain injuries and those type of procedures have increased. And so we think, again, with the breadth of our product portfolio, that's going to continue. And then with the addition of these new products, that's going to continue to fuel it. So we're actually in quite a good spot.

But neuro, in some cases, had a 6-month running start over kind of TT as far as access from at least our perspective of the world..

Yes. And I would just say, too, and why we're confident in raising our guidance is we are seeing better than expected in our direct markets outside the U.S., which have outperformed and we're expecting that to continue. So certain markets in Asia, such as Japan and China that we've talked about are performing really well. We expect that to continue.

And certain direct markets in Europe are also outperforming. And so I would just highlight the international performance has been quite good, and we're expecting that to continue. Kaila, you also had a question ACell.

Can you just repeat that?.

Yes, sure.

Just what gives you guys confidence that you can recover those lost revenues in ACell? Again, over sort of the next 12, 18 months going into next year?.

Yes. No. Listen, again, we think this is a great asset. The team has done a real nice job in terms of the integration work. The issue that we're facing at the moment is short term just because of the rep access being challenging and not being able to do face-to-face in-person selling.

And I think that will subside over the next few months, and we'll start to see better performance sequentially in the business. And then moving into next year, you'll start to see the growth that we expect.

And so we're very confident that this is a great asset and that we'll work through the short-term challenges that are really caused by COVID at the moment..

Our next question comes from Matt Miksic with Crédit Suisse..

And I should say congrats Pete on the opportunity and good luck to the team in sorting out succession, but look forward to seeing that all come into play. So a couple of follow-ups just on -- I'm sorry to ask after the ACell changes and the rep access comments that you made.

But since we haven't heard a lot of that type of -- those types of challenges from other folks in the space. Just to maybe clarify, is this the difference between -- you point out emergent and critical ICU cases for cranial surgery and so on, being some of the first cases that came back.

We hear a lot about reps in ortho and spine and cardio being also given access. But is this the difference between sort of rep support for acute care surgeries is one thing.

But reps and access to selling new products or bringing new products to a new call point just has a different set of priorities around it, and that's what you're facing? I don't want to put words in your mouth, but I'm just trying to understand the difference..

Yes, Matt, it's a very good question. So first of all, the emerging nature of neuro has definitely the need for a surgeon to ask for a rep to come in and be invited in more often in neurosurgery than the rest of our portfolio. So that's clearly some of it.

But your other point is a really important one here is, if you have a -- if you're a rep that's been in an account and you inherit a new product, either an NPI that we created or one that we buy, there needs to be some time for discussing with the doctor.

There needs to be some time to get it on the shelf, particularly if it wasn't a stocked item, it was a carried-in item. And so that takes a little bit more time. In the case of ACell, look, we transitioned this in the midst of COVID.

We knew that in the January time period, and we handed off in certain territories the product from a legacy ACell rep to an Integra rep. And that Integra rep needs to get in and see those doctors that were using it, with the access to those doctors was reasonably limited for really most of the first quarter and most into second.

It's now opening up significantly. And that's really at the core of it. I think it's equalized out now. But as Carrie said, our guidance reflects the increase in the second half, but we're also kind of positioning it in such a way that we want to make sure that we come back appropriately.

And I think longer term for this product, there's no reason why it won't be a wildly successful product in our portfolio. It complements everything we do. And we had a slow start, but we'll get it fixed and be back up where we expect to be here as we head into '22..

That's great. And then 1 follow-up, if I could, on margins. So Carrie, I appreciate the color on sort of the mix and progress on the gross margin line. And great to see sort of the -- it sounds like slightly better, expanding opportunity in EBITDA.

Can you talk a little bit about the ACell reduction in expectations? Feels like maybe you were clear about this as sort of a headwind to gross margins.

Is there anything else happening in the integration process that's coming in better or worse or different, whether it's related to the pace or the slowness of the access or anything else that you can comment on in terms of EBITDA contribution, specifically from ACell..

Yes. Matt, I would say from a gross margin perspective, it actually was additive, meaning it comes in a very healthy, high gross margin in our portfolio. So it does support a favorable mix as it continues to grow. So as we move from the second quarter and we start to see a bigger ramp and obviously get back on track in 2022.

It will continue to drive favorable mix. So from that perspective, it's contributing to some gross margin. And then on the -- just overall, what I would call SG&A type of synergies, we're -- we've accelerated that. I mean we're well on track on that. We've seen some benefit of that in the second quarter.

So it is definitely tracking ahead of schedule in terms of realization of our synergies. Remember that business when we acquired it, it was breakeven. And part of what we needed to do was to rightsize that business. A big piece of that was on the sales channel. And obviously, we've achieved those synergies.

As Glenn mentioned, we're well on track, and I've seen the benefit in our second quarter numbers. So yes, I mean, certainly, from a dollar perspective, you lose a little bit when you don't hit the revenue. But overall, the margin mix is favorable..

Our next question comes from Anthony Petrone with Jefferies..

And I want to second, Peter, congratulations on the move. And also good luck to the team as the transition gets underway. Maybe one, just on the broader strategy.

It sounds like from the prepared remarks, Peter, as it relates to your transition to the Board really has a mindset where the strategy that has been in place over the last several years, which has largely been a portfolio reshuffle sort of strategy is going to remain intact.

But as you look ahead, does that accelerate? Does it slow down? Maybe anything from the Board level as they're thinking about this transition. And I'll have a couple of follow-ups..

Yes, Anthony, I think I've kind of communicated pretty much everything I can relative from that standpoint. From a Board standpoint, obviously, we have a very active integrated Board, they're heavily involved with our strategy.

And again, a big part of what we've been trying to do over the last x years was to bring assets in or only keep assets where we know we can be a strong player.

And the reason for that is because as hospitals continue to consolidate, competition consolidates, having areas where you can have a leadership position, we think is the way that future growth, both top and bottom is going to come. And I think we've been able to demonstrate that.

So from that standpoint, I think the Board is obviously very much aligned. On a future standpoint, we have obviously adjacency areas to neurosurgery. You can argue that from the neck up, we have expertise at some level. And so there's lots of interesting scenarios there.

And on TT now, we -- as we mentioned at the Investor Day, moving broader than wound care is a big opportunity. We've talked about breast. We talked about nerve. We talked about hernia. We've talked about other areas within plastics. All of those have accretive margins and growth rates.

And so I think whoever comes into the role, I think they'll have plenty of opportunities with the base business to continue to grow and a pretty nice pallet to expand into other faster-growing areas. And I think that's kind of how I see it.

And I think I can't speak for the Board, but I think the Board is very much aligned with what we've laid out at this point in time..

And again, congratulations to you and the team and good luck on the transition. The follow-up would be on margins. Just going back to the LRP target, the 28% to 30% adjusted EBITDA margin for 2023. Just trying to get a handle on that just given the ACell revision here.

Where does the ACell margin profile sit in that LRP target? Perhaps in the near term as a headwind. But the offset, certainly, Pete, you mentioned the new product categories, Aurora, SurgiMend, breast, CereLink, of course, those all seem to be set as margin tailwinds. So just maybe the complexion and mix as you approach that 28% to 30%.

Where does ACell now sit in that equation and where the new products contribute in that equation?.

Yes, Anthony, I'll take that one. And as we mentioned, ACell, our expectation is that we will be back on track in 2022. That's our expectation for our accretion being additive in year 2. There's nothing that would suggest that we will not hit that target in terms of additive from an EPS perspective.

And it favorably contributes to our margin profile, both in gross margin as well as the SG&A cost savings that we've been able to achieve. As I think about the long-term 28% EBITDA margin, 70% gross margins, all of those levers are still intact. And so just as a reminder, just refresh on what those levers are.

Starting with gross margins, there's a number of things that continue to be tailwinds for us in gross margins. Let's start with the mix piece of those pieces. First of all, you think about revenue recovery, as we mentioned, not all of our portfolio is yet at 100% in direct capital still have positive growth opportunity for them.

And as Glenn mentioned, CereLink, that should be a very nice 2022 lift for us as we think about next year in terms of revenue as well as margin opportunity for us. You have, overall, the TT side of the business, which has higher margins than CSS. And so as that business continues to recover, including ACell bringing strong favorable mix to that.

And then as we again wind down out of those discontinued products that carry lower margins, all of that is helping. And 1 last lever on the gross margin side is around manufacturing. Productivity efficiency, we've got 2 big initiatives there.

One is exiting the TSA agreement with the Codman integration at the end of the year that will provide some gross margin lift. As well as we're closing a facility in France by the end of 2022, which help -- should help as well. And then we've got just overall, just SG&A leverage as our revenue recovers productivity improvement.

So all of that would allows us to stay on the path of a 28% type of EBITDA margin..

Yes. And I would just highlight the fact that these new product introductions and these key catalysts that I walked through in some of the prepared remarks are all accretive to the company average. And so when you look at those growth drivers in the short to midterm, those are all going to be nice tailwinds for us relative to our margins..

Our next question comes from Ryan Zimmerman with BTIG..

Congrats, Pete, and the team. So I just want to ask on the margin side a little bit. Carrie, you mentioned just some of the inflationary pressures that you're seeing and higher freight costs. And you talked a little bit about just adding potential for price.

Wondering where you could specify kind of where you can pass that along, specifically within the product category versus maybe other areas where you intend to absorb some of those inflationary pressures?.

Yes. So right now, I'd say the biggest impact is around the tight labor market. Certainly, a couple of different things. We have open positions in our factories.

We have open positions in our SG&A areas where it's happening in our factories, that creates some idle capacity cost because of the fact that you don't have a full team as you're trying to ramp up production. However, it helps on the SG&A side because you don't have all your positions filled.

And the second area on the labor side is we are seeing some select wage pressure at certain sites where we're trying to ramp up. As we think about Boston, as an example, that's an important side as we're trying to ramp up there and seeing some wage pressure there.

In terms of the supply side, it's really right now limited to just longer lead times as it relates to select sourced materials that creates some amount of expedited freight costs that we're dealing with. But for the most point, I think we've been successful. We've got long-term contracts.

We have opportunities to offset some of that internally with initiatives. So we haven't seen a lot of, what I'd call, material inflation yet. It's something we're watching very, very carefully. We do have the opportunity to price. We have been successful there, and I'll have Glenn maybe talk a little bit there our approach to price.

But I would say we have the opportunity both on the CSS side as well as the TT side to look at opportunities to pass through in terms of pricing.

Glenn?.

Yes. No, the only thing I'd add is, first, on the cost side, yes, we are seeing some, obviously, headwinds as it relates to cost pressures. But I want to recognize our global operations and procurement teams. They've done a real nice job to identify a number of cost savings initiatives over the last 12 months to offset some of these cost pressures.

And so I want to recognize the team that's been working hard to minimize the impact of what you're seeing. As it relates to pricing, again, there's opportunity for some limited price increases given the increase in the materials that we're seeing coming into our sites.

And Carrie mentioned, we're fortunate that we've got some longer-term contracts where we can offset some of the short-term headwinds around this. But I would anticipate -- in certain cases, we'll have some select price increases to also mitigate the effect on both sides of the portfolio..

Got it. And then, Glenn, for you, as a follow-up.

Can you give us kind of a state of -- the state on PriMatrix just following that study? I mean, in terms of kind of covered lives and where you're at and where you need to get to and how to think about your reimbursement strategy with PriMatrix given the study?.

Yes. So keep in mind, we had pretty good reimbursement prior to the study. So I think of that as over 100 million covered lives, but we really didn't have a lot of covered lives with the commercial payers.

And so what this does for us with this clinically and statistically differentiated data that is significant and the results are showing significant improvement in DFU closure in 12 weeks versus standard of care enables us to now go to the commercial payers over the next 6 to 12 months and increase the amount of reimbursement.

So you could think of it as doubling the amount of covered lives from what I just said as a rough order of magnitude. And so that's obviously going to open up more sales opportunities and more revenue growth for PriMatrix. And it's been a product that's been very well received, both inpatient and outpatient.

And so this should be a real nice opportunity for us as we move forward. But again, think of it as doubling the amount of covered lives once we get through going to all these commercial payers and getting reimbursement..

And just to put a finer point on that as the last, Glenn.

I mean doubling over what period in your mind?.

So the base number of covered lives today is over 100 million, so going over 200 million. Over, call it, 12 months. I think it's fair to say in 12 months, we'll have -- whatever we're going to have from a reimbursement perspective in place..

Our next question comes from Robbie Marcus with JPMorgan..

Two for me. Maybe first, Carrie, we've touched on it a bit, but I wanted to just dig into it a little further, particularly as it relates to the guidance raise and what's implied for third and fourth quarter here. The beat was a very nice beat, but we're now looking at third quarter guidance that captures the street at the high end.

And what's implied for fourth quarter is also capturing the street, but at the high end. So I was just trying to get a better sense of exactly what's going into it, how much is conservatism versus lowered thoughts on second half. How much of the impact is from lower ACell.

And if FX or anything else played into the decision here?.

Yes. No, FX did not factor into any change in our thinking there. And so we're not assuming any significant FX tailwinds in the second half of the year. But I would look at it -- again, I'll go back to that math equation. I said $15 million raise.

Within that, embedded within that $15 million raise is taking ACell down about $13 million to $14 million, which implies that the base business, the organic base business is up $28 million to $29 million. So we've derisked ACell. We've had a slower start. I think Glenn and Pete have talked about that.

I'm not sure that I would characterize it as conservative. I'd say it's balanced. I would say that we've derisked the second half. We think that what we're seeing in the base business is really some really nice trends. Still have the opportunity to see some further growth in indirect and capital as we exit the year and move into 2022.

So I would look at it more just from timing. I answered Kaila's question on the Q3 that the $382 million to $389 million does capture some normal seasonality in the third quarter as well as maybe some pent-up demand in the second quarter.

But the base business is a 6% organic growth in the third quarter to 2020 and some nice growth in the fourth quarter as well compared to either 2019 or 2020. I think overall, we're very pleased with the performance of the business thus far..

Sorry, maybe I should have been a little clear. I meant more focused on the bottom line..

Yes. On the bottom line, I would say the thing, Robbie, to consider is that we'll probably see some additional normalization of OpEx in the fourth quarter -- sorry, in the third quarter. We have some -- as I think about the second half, we've got some investments we need to do around new product launches. Glenn talked about CereLink.

We're obviously looking at opportunities on the breast side. And so we want to continue to invest in Aurora. So lots of new product opportunities there that we want to continue to invest in growth with clinical studies. So I would say the third quarter does comprehend some additional investments that we want to do in the third quarter.

I think -- I expect that we've got plenty of room to make those investments, but it is a priority for us in terms of investment. From a gross margin perspective, Robbie, I would say second half will be modestly higher than first half.

I think some of the manufacturing pressures around the tight labor supply and some pressure on the long lead times will continue to persist into the second half. But even with that said, I do think that we'll see some modest improvements in gross margin into the second half compared to the first half..

Robbie, I would just add that Glenn mentioned this earlier, and we talked about it at the Investor Day, the 5 big kind of we view as breakthrough technology opportunities that we have are all on track.

And what that means is the ramp of their spend will begin here in the second half, which is great news because all of those have the opportunity for significant growth profile, everything from being in a position to file a PMA for breast to the discussion on Aurora.

And so again, if you think about Aurora, this is really the first platform that can be a regularly used product to actually minimally and invasively remove a brain tumor.

And so the work with clinicians on all the big names that you've heard in neuro institutes doing work on that, how we customize our instruments, including CUSA and other things, that's going to generate some added tweaks and work, which we want so that we can create this really differentiated custom set.

And in the case of that, no other player out in the marketplace will have something like that. And so a lot of that work to optimize it starts here within Q3 for all of those..

Great. And maybe just 1 last one. On R&D, you guided at the Analyst Day to get that up to 6% of sales in the next few years. It came in lower than expected or at least we expect in the second quarter.

How do we think about when we start to see that tick up? And really what projects is that going to be focused on?.

Yes. Robbie, I think it's really consistent with Pete's comments that I would expect that you'll start to see that R&D investments move up in the second half of the year as we, again, continue to advance some of those new product opportunities.

So that would be -- my expectation is that consistent with some of the spend increase that will be -- a piece of that will definitely be in the R&D side..

Our next question comes from Matthew O'Brien with Piper Sandler..

And I'll just stick with 1 question. And I'm sorry to kind of beat a dead heart here on ACell. But you guys kind of swapped out extremities for ACell. And so there's a lot of attention on it. That's why I wanted to ask a bit more. That was a $101 million business back in '19, and I get the pandemic and access to accounts now.

But now we're down about 30% as far as what that did in '19. So I guess for investors as they're really focused on this asset based on what I just said.

Can you give us any more just commentary about sales rep attrition, account attrition versus what you had expected? Is it much better on those 2 metrics? Are you guys -- is it anything on the accretion side? Things seem to be moving faster there.

So maybe you're cutting a little bit faster and that's affecting the top line a little bit? And then when do you think you can get back to about $100 million in sales in that business? Is that kind of 2023 or beyond?.

Yes, Matt, thanks for the question. Just to set some of the groundwork on the $101 million reference point for ACell. A couple of things to keep in mind. We had about 1 month less of sales this year. So when you look at that 30% reduction, obviously, you should factor that in.

And then there's certain accounting for GPO fees that are different within Integra versus how they were treating it. So those are 2 factors. But relative to the business itself, listen, I think the attrition has been as expected. We've taken the necessary actions around synergizing the sales force. For us, it's really just around access.

And I think once we start getting better access in these face-to-face meetings in the second half of this year, we'll start to see the pickup in the business. So it will come. I'm very confident in that. When we get back to something that's close to $100 million, we'll have to talk about as we get into 2022.

I don't think we're ready to commit to anything other than expect to see a sequential improvement in the business, and we expect long term, this business to be growing in line with the overall Tissue Tech business, which is in the 7% to 9% range..

Okay, Glenn. But just to be clear, you're not seeing anything from an attrition perspective on the sales force side or account side competition getting a little bit more elevated here. I don't know if TEI is an analog you can use as well as far as how you did on the integration side there, but I think that went pretty well..

Yes. No, just normal attrition. So nothing abnormal that we've seen in the first 5 months that we've own the asset..

Yes, and I would further say as you look at Q1 to Q2, I mean, they're not comparable periods because we didn't own ACell for the full quarter. But as you look at kind of on a daily kind of run rate, we didn't see any deterioration in the business. We just didn't see the growth that we expected.

But I don't think there was any deterioration from the first quarter to the second quarter. It's just that we just have had more limited access. And it just didn't allow us to ramp as fast as we expected to..

Our next question comes from Joanne Wuensch with Citi..

So many have been already answered. But very briefly, what kind of CEO do you think is the right person for the next phase, given how much progress you've made over your tenure? And then my secondary question was -- and again, I'm going to apologize, but I feel like we're all circling the same question.

If you lower ACell, raise total revenue, what is it that's giving you the confidence in that raise of the lower revenue? Is it new products? Is it momentum in the recovery? Any sort of like that would be helpful..

Yes. Joanne, I'll take the second part of your question, and I'll defer to Pete on the first part. But I think in terms of the underlying business, it's very broad-based. I think with the exception of the indirect markets and capital that isn't yet at full recovery, most of the other parts of the business has recovered very, very nicely.

The procedure-based pieces of our business in neurosurgery, as Glenn mentioned, the disposable, the consumable pieces of the business, our IDRT skin products, SurgiMend products all are seeing some really nice rebound in growth.

And even instruments, as I mentioned in my second quarter prepared remarks here, 4% organic growth compared to 2019 when that's a business that would probably grow low single digits. So very nice performance there.

And so as we think about going into the second half, I go back to all of -- some of those comments that Glenn made about products that we launched in the middle of 2019. We had about 7 products that we launched in the middle of 2019. And COVID interrupted that opportunity to really see that nice ramp on them.

And that's what you're seeing is you're seeing a lot of those products really taking hold as the recovery comes back in. So it's the combination of international growth and the combination of some NPIs as well.

And certainly some pent-up demand and deferred procedures that kept some of that recovery handcuffed in the second half helping us in the first half as well.

Glenn, anything else you want to add?.

Yes. The only other thing I'd highlight is and why we feel more confident in the second half of the year as capital has lagged, but the actual capital funnels themselves are really strong right now. So we've got a lot of things going on relative to trialing and advancing our capital through the selling cycles.

And so I believe once we start to see that open up, we're going to see a really nice windfall on the capital front in the second half of the year. And again, that's lagged in the first half of the year. But when I just look at the activity, I look at the progress in terms of the funnel, it's the strongest I've seen in a very long time.

So that's why we're also confident..

Joanne, just on the point, look, I would say that the key here is the company is in very good shape. I think for you followed it, everything from our systems and the speed that we can access data to close to the product pipeline that we have.

And so finding someone that can come in and obviously take what's here and be able to make it better, but have a vision for the future about how to find faster growth.

I think we're at -- and we use this term inflection point for a reason, the amount of things that need to be kind of fixed internally versus the opportunities to take things and focus on them grow. The scale has clearly tilted to more tools in the bucket to be able to focus on to have the company grow faster.

And I think we talked about that in the Investor Day and I think finding the right leader that can come in and balance the 2 of those is ultimately what I would hope for. It's obviously the Board's decision to do so and find that.

And I think there's a lot of interest and excitement about the company, and I think we'll come out here before the year is over with the right leader..

Our next question comes from Shagun Singh with Wells Fargo..

So you indicated that the base business was up about $28 million, $29 million. How much benefit did you see from backlog in Q2? And what are your expectations for the second half? And then with respect to U.S.

capital, can you give us the growth rate, and I'm sorry if I missed it, relative to the double-digit pace of decline that you had posted within advanced energy in Q1?.

Yes. Shagun, I'll take that.

In terms of the $28 million to $29 million, the question was regarding -- what was it?.

The backlog..

The backlog. Yes. The backlog, in terms of some of that pent-up demand, we -- I think there was a piece of that. It's hard to be able to quantify how much of the $12 million beat the upside of our -- the high end of our guidance range came from deferrals or pent-up demand.

But certainly, a portion of that did as we think about the surgical reconstruction side of our business was down in the first quarter year-over-year, and it came back really nicely in the second quarter. Instruments saw a really nice recovery in the second quarter. So certainly, there was elements of that pent-up demand benefit in the second quarter.

And as we think about the third quarter, we tended to try to normalize that in our third quarter revenue guidance there. But overall, we're just seeing some nice recovery in most parts of the business.

And as Glenn mentioned, really where we think the opportunity in the second half will be seeing more normalization of capital, seeing a really full pipeline and expect capital to be a contributor, which goes to your next question, Shagun, which is capital in the U.S. was still -- was down in the first quarter.

It's still down in the second quarter, about single digits -- high single digits. But sequentially, it was up from Q1 to Q2 in the U.S.

And so as we think about, again, going into the second half, seeing those full pipelines and capital gives us some nice comfort that capital will rebound nicely in the second half, coupled with the clinical launch of CereLink into Q3 and then following full market release in Q4..

Our final question comes from Jayson Bedford with Raymond James..

Congrats, Pete. I'll just -- just a couple of questions that require, I think, pretty quick answers. You mentioned restricted access.

Is this restricted access dynamic negatively impacting sales in your base tissue technology business?.

No, because again, they have the existing relationships. So it's much easier to do the sale with our existing portfolio. So we haven't seen that impact our base business. It's really around new products and obviously, the transition of the relationships from the ACell portfolio. So the answer is no..

Okay.

And then what is the level of discontinued revenue implied in the organic growth guidance for the year? And then also, what's the assumption for FX in '21?.

Yes. For FX, let me start with that. We saw probably $11 million to $12 million of benefit of FX in the first half. We're not assuming a tailwind or a headwind in FX in the second half of the year. So depending on where rates go, we're not really counting on FX to be a benefit in the second half.

So about $11 million to $12 million was the FX for the first half of the year. And then for discontinued products, discontinued product revenue has been a little bit higher, again, as people continue to do some last time buys there. So probably about a $10 million to $11 million type of year-over-year change in the discontinued revenue.

About $20 million of revenue and discontinued products in 2020 and about $10 million to $11 million in 2019. So essentially, that year-over-year delta is probably about $10 million to $11 million..

This concludes our question-and-answer session. I'd like to now turn it back to Peter Arduini for closing remarks..

Thanks, Stephanie, and thanks, everyone, for your questions. Look, I'll just close by saying that there's never been a more exciting time at Integra. We're clearly at an inflection point to accelerate scale and growth and really market leadership.

We're now aligned to faster growth markets with the changes we've made and the discussions we've had on the pipeline. Hopefully, you can see that not only do we have a lineup of products with faster growth but higher margins, which will drop through. So thank you for your continued interest in Integra.

Look forward to speaking with many of you here in the near future and providing an update on our progress at the next quarter. But in the meantime, please enjoy your summer, and that concludes our call. Thank you..

Thank you, ladies and gentlemen. This concludes today's presentation. You may now disconnect..