Integra LifeSciences Holdings Corporation (IART)
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38th Annual J.P Morgan Healthcare Conference

Jan 15, 2020

Robbie Marcus
Managing Director and Senior Analyst, JPMorgan

Hello, everyone. I'm Robbie Marcus, the Medical Device Analyst here at JP Morgan. I'm very happy to introduce our next speaker, Peter Arduini, the CEO of Integra LifeSciences. Peter.

Peter Arduini
CEO, Integra LifeSciences

Thanks, Robbie. Good afternoon, everyone. Hope everyone's doing well. I'll start off with giving a little bit of overview. We have some safe harbor statements here, as well as I'll be using some non-GAAP financial metrics to talk a little bit about our numbers. Integra, by the numbers, for those that may not know the company that well, we are a company that, based on our 2019 numbers, roughly about $1.5 billion of revenue, of which 65% is in our Codman Specialty Surgical business, which is a combination of specialty instrumentation as well as a broad array of products that a neurosurgeon would use on a regular basis, and then 35% of the business is our Orthopedics and Tissue Technologies business.

The orthopedics business, which is primarily focused on extremities, and the broader portfolio of tissue technologies is a regenerative portfolio from chronic wound, acute wound, into plastic and reconstructive surgery. I'll talk a little bit more about our pre-announcement we made last evening, but guided towards 2020 of roughly 5% organic growth and double-digit earnings per share growth here for 2020. What makes the company special, as well, that kind of brings things together of why neurosurgery and a tissue business is over 40% of our sales come from regenerative technology products, which are either based on amniotic, they're either based on bovine, engineered collagen-based products, and they're sold either in neurosurgical applications or in a broad range of tissue applications.

And since we've been really building a portfolio of new products, 25% of our revenue growth here is going to be coming in from new products that we've launched within the last 18 months. We also have now 30% of our revenues coming from outside the United States. That's doubled, really, in the last five years. And now we have a platform with the integration of Codman that can allow us to even accelerate that faster. So where are we going? We've got leading marketing positions. We're the number one player globally in neurosurgery. We've got leading positions in plastic and reconstructive surgery. We touch into podiatry. We touch into, definitely, trauma areas. But the use of products that regenerate within the body to either solve wound-based issues or deal with post-surgical applications relative to regenerating tissue in the body, we play a leadership role in.

Our acceleration of growth is focused on, as we show here, new product launches. We've launched about 10 new products in the last year. They typically have a three- to four-year life cycle to peak your sales, and we're only about nine months into those. Secondly, on margin expansion, not only are we focused on accelerating our top-line growth, but we have a very focused pathway to take us from about 24% EBITDA margins to 28%-30% by 2022, something we laid out strategically a few years ago. A lot of that's tied to faster growth products in the mix of some of the new products you brought out, a very conscious and methodical focus on product portfolio rationalization, which also involves rationalizing some of our footprint, and then G&A leverage. Some of that tied to scale.

Some of that tied to restructuring how we run the company based on, for some of you that have followed us for many years, having 30 ERP systems, and this year we ended up with just one global ERP system, which, as you can imagine, has enabled us to be more agile and faster, and how we think about our business, and financial strength, strong balance sheet, and a capital allocation strategy that's focused on debt reduction, acquisitions, which we plan to be active this year, and, as we announced last evening, a share buyback program as well, so this is a snapshot of our business and our composition. You can get a quick look. We run it in two global segments: CSS, again, our Codman Specialty Surgical business, and OTT, Orthopedics and Tissue Technologies. The boxes there on the left kind of show you the breakout.

65% of our business, again, is in Codman Specialty Surgical. You can see neurosurgery represents the largest segment of 46%, instruments at 19%. If you get down to OTT, orthopedics, which we many times get a lot of questions about, at this point in time only represents about 7% of our total business within OTT, and excuse me, within the company, and regenerative and skin tissue products represents about 28%, and you can see the 30% of the combination, which is international. One of the things that you notice is we benefit from some healthy growth markets, particularly in neurosurgery. We've seen growth pushing 5%. That range of that market has been 2%-3% over the years, but we've seen some acceleration mainly drive to new product introductions and expansion around the world. In areas such as tissue technologies, you see nice double-digit growth within those areas.

I'll talk a little bit about each of the segments now. Codman Specialty Surgical, as I'd mentioned, we are a leader within the segment. We've got now over 14 number one leading position brands. You could go into pretty much any neurosurgical institution around the world, and they would know Integra. In particular, they would know Codman, which is one of the key reasons we branded our segment with the Codman name post the acquisition from Johnson & Johnson. Any type of procedure done, we may have 10, 12, 13 different products being utilized within any given procedure. Because of that, then, we've been able to build out the largest direct sales force really around the world. In many markets, as you can imagine, in the Middle East and Asia, we have a combo or hybrid structure with distributor partnerships. Some that have extended for many years.

But between Western Europe, the United States, even markets such as Japan, we've been able to actually now move forward and build out direct organizations, which has helped us significantly in our clinical sales. The business here is just about $1 billion of our $1.5 billion. And an interesting component here is that you'll see down below I mentioned that the market for neurosurgery worldwide isn't a huge market. It's been about $3.5 billion, growing 2%-3%. We've been able to accelerate that with innovation. And with some of the new technologies that have come into the space for us, as we look at it, such as some recent acquisitions that can bring us into intracerebral hemorrhage and also bring more minimally invasive technologies into traditional neurosurgery, we see that addressable market over the next few years expanding from $3.5-$4.5 billion.

Also, that additional growth, that additional $1 billion in growth, actually having a faster growth rate than the traditional core business. Those are some of the things that we're excited about. We did two acquisitions last year. I'll talk a little bit more about those. This is a really great business for us. The acquisition, the integration is fundamentally completed and has just been a great success. We bought the business originally from Codman. It was about a 1-2% grower. Ours was roughly 3%. Together, they've been growing. We represented 3-5% range, and we've been growing in the upper end of that range since the acquisition. This is a good chart to show you where we've been with the integration activities.

For those of you who follow a company that do carve-out acquisitions, which is kind of shorthand for 60% of what you need to run the business you didn't get, and you need to build that for a period of time to stand up the business, and then over a weekend flip a switch and shut everything off and come onto your systems, we accomplished all of that last year. We did the United States fundamentally in 2018 and 2019. We did the rest of the world. We had a few hiccups here or there, but I think the teams built the right hedges and appropriate approach to make sure that we could deliver on our numbers while making those transitions.

Really what's last is the gray box at the bottom, which is product line by product line out of one individual plant to our new facility 30 minutes up the road. We will migrate products over. As we migrate those products over, we'll bring up the new line, make sure it's running well, then shut the old line down. We view that as a low-risk move. Also in our hands, we believe we'll be able to actually make those products at a lower cost, which will have benefits in the long run. Orthopedics and Tissue Technologies at a glance. We've got top positions here as well, primarily within our tissue portfolio. When it comes to either chronic burns, when it comes to chronic wounds, or it comes to tissues that are used for trauma-based procedures, we have the leading and most broadest portfolio in the marketplace.

We also bring in some other key leading products for dealing with chronic and also acute wounds. We've spent a lot of energy and focus in 2018 into 2019 of getting our channels right. We've got four dedicated channels now that have focus particularly within inpatient and outpatient wound. We also have a group that calls into plastic and reconstructive surgeons primarily for upper chest wall and breast-type reconstructive work, as well as in hernia repair, and then a dedicated channel into extremities orthopedics. You can see our breakout here with wound reconstruction being the largest, extremities being 19% of OTT, if you recall, 7% of the total company. And private label, which is a combination of different regenerative tissue products primarily that we've deemed that we're not going to go into certain markets that we will make for other partners, primarily other large global med tech partners for us.

And that opportunity, as you can see here, market-wise, is quite large at about $6 billion. We had some major capacity expansion that we did here in 2019. I would argue that if we had the capacity in 2019, the orthopedics and tissue business could have grown at a much faster rate. We pretty much had a governor or control on that based on the supply. We've been able to actually add capacity in multiple plants as we exit this year. So we're in good shape here to begin ramping that growth back up in 2020. And so between stable sales force, some new products, and added capacity, those are really the growth vehicles we see and add confidence into our projections for orthopedics and tissue technologies in 2020. Our international business, as a subset of each of the areas, has just done really well.

So, over the last year, we've really been able to kind of step up and see the benefits of the platform growth. I've mentioned in the past the acquisition of Codman, which over 50% of the revenues were outside the United States, enabled us with the right amount of EBITDA to put the infrastructure in markets to build that out. And so we advanced our international strategy by at least seven to eight years by having that. What does that mean? You can see some of the numbers over doubling the revenues. And just to give you examples in Japan and China, markets where we had either two or three people or a handful, now we have 70-100 direct reps. And as far as dedicated distributor reps in a country like China, we may have up to 150-200 on top of that.

And so we've pretty transformed our look and who we are and really have become one of the largest players relative to our focus markets there, which is primarily neurosurgery. So a lot of exciting things going on in that area. And as you can imagine, if you've been indirect and going through a distributor, you capture X dollars, you now go direct, bring some of your leading products that you've had in the United States for many years in, you double that dollar amount, and you also capture a larger percentage of the share. So products that you might have heard of, such as our CUSA tissue ablation device, number one device used in the world to remove brain tumors, our dural sealant products to close up the dura after a craniotomy. In many cases, our brand new introductions into some of those markets.

As an example, we just introduced the dural product DuraGen into Japan, the first ever product of that type, and it's off to the races doing quite well. That was just in the fourth quarter. So this is an important chart. If you think about the company and kind of where we are with capacity and capabilities, this chart labeled the execution of our strategic initiatives really just kind of gives you a view of the big chunks of work that we've knocked off or have yet to do over the past few years. And I think if you think about it, and we're honest how we think about our growth profile, we've been shy of 5% growth in 2018 and 2019. And a lot of that has to do with the massive changes and implementation of needed changes within the company.

So whether it be fundamentally all of our sales territory structures in 2018, heavily tied to Orthopedics we changed, but then also the integration of Codman, which meant every sales territory was changed in 2018 going into 2019. The global integration coming off of all the J&J systems, adding customer service centers in areas we had never been before, or a logistics provider, or a labeling and RA structure, and all of those things, that was all completed during that time period. And you can see things that I mentioned, such as the tissue technologies capacity. The takeaway I want you to have from this chart, though, is that 2020 is really the first year where 90% of this is behind us.

That really gives us added capacity both in leadership from my team and their ability to focus on growth initiatives as opposed to integration initiatives, as well as taking out many factors that drive just instability or drive ability to actually have more fluctuation in your overall results. So we're very excited about having many of these things in place. Again, a lot of these items, particularly things like the IT system stuff, are events that set us up to be a more agile company, grow at a lower G&A percentage, and really set us up to be a faster growth company in the future. From a new products launch standpoint, as you all know, the lifeblood of med tech companies is to bring out new technologies that solve critical issues for patients. During all this integration, we've also kept our R&D teams quite busy.

What you see on this list here is almost 90% of these products were launched really in T minus nine to six months ago. Pretty much all of these products have peak year sales at year three or four, so we have a lot of gas in the tank here to kind of take these to the next level, and when you think about what's going to drive a majority of the incremental growth in 2020, as an example, products as you see on this list will do it. We also have some new products that will be contributing this year, such as the AmnioExcel Plus product, which we did an early launch last year, but we're constrained by supply. That will change as supply constraints are lifted.

And our CereLink monitoring system, which we have a very large captive base of neurocritical monitors that are in dire need of upgrades, and our base of customers are very excited about seeing that. But this is a great list of products. We have a nice pipeline of more coming out behind this, but this is kind of the underbelly of some of the growth items that will be driving our 2020 plans. I mentioned that we did two acquisitions last year, really important ones that fit into neurosurgery. They were a little different than what we traditionally do. They're technology deals that didn't have revenue or profitability at the time, but they solve some interesting scenarios. Arkis was a technology that reduces occlusion or clogging of catheters or other type devices when you place them into the brain.

One of the biggest challenges for neurosurgeons for evacuation catheters or long-term wear catheters, such as a shunt, over time they get plugged up. And they have to be removed. That's expensive. It's risky. It's challenging. This technology and coating we have access for to apply to all of our different product lines, and we think is going to be a very interesting game changer. We also have a leading platform already of anti-infective coatings, and so if you put those two together, that will be a very exclusive platform that nobody else in the industry has, and so we're working diligently on those. Some of those products will start coming out in late 2020, but the majority here is in the 2021 range when we'll see impact, and then we also have platform evolutions out into 2022 and 2023.

Rebound Therapeutics is kind of a game changer expander for us. This is the one that I talked about could expand our market by over $1 billion pending on how far we go. It's a platform technology that in some ways takes items that were too expensive to be utilized in previous years and because of the cost curve and commercial, now comes together in a healthcare environment where we can take basically a scope that can be added into the head through a burr hole, a small drill hole, a little bit bigger than a pencil. In that device can be integrated LED lights, very high output lighting to provide channel lighting, which we have intellectual property on, and also a high-definition CCD camera on top that can record.

And that can be all plugged in, plugged into your standard monitors in your OR theater, and it's a one-use device that's thrown out after it's done. Today, to use something like that now, you either need expensive microscopes, you need other types of capital equipment, and once you get outside of a tertiary large neuro account, most people aren't going to spend that money, let alone in markets around the world. But being able to have a product that you can actually open a sterile pack and use in smaller institutions as well as locations around the world, this is very exciting. That's the underlying component of the technology. With it also, there will be different tools that will be used. And so there's two market areas. One is called intracerebral hemorrhage, which are deep bleeds in the brain.

These are ones that you cannot reach through endovascular routes because the vessels are too small to get there. Many of those patients today receive a blood thinner or put in the ICU to see how they recover. There's a lot of emerging facts that show that if you can evacuate that out in a very fast period of time, the patient will have a much faster outcome. This is the realm of a neurosurgeon, not typically a vascular or interventional radiologist, and that's our call point so we're very excited about that opportunity, and there's a lot of work going on there. In the photograph, you can see a handheld device. That's an evacuator or a suction evacuator that will have other features on it as well that will allow cauterization, suction, again, utilize down this working channel with lighting and filming integrated.

That's one set. The other set out of this technology is creating a better minimally invasive neurosurgery suite. What do I mean by that? For those who have seen neurosurgery, it's still rather primitive with a craniotomy. It's a wide open access with a port. Again, being able to have a little bit larger port to work down, but take products such as our CUSA and many of other instrumentations and adapting them to work in this minimally invasive access port is something we're very excited about. Again, two examples that we're funding aggressively and moving forward with that in the 2022, 2023 time range, we believe will have some strong impact within our growth and our portfolio.

So kind of wrapping up here in a few pages here, this for those that haven't seen our press release that we put out last night, our preliminary 2019 revenue and 2020 results. I've commented on some of these already, but we commented last night that we will be at or near the low end of our previously communicated revenue range, which was $395 million-$400 million. Our organic revenue growth then will be slightly less than 5% for Q4. And we also announced our preliminary 2020 financial guidance where we said that for 2020, our reported revenue range will be in the range of $1,550-$1,570, and our organic revenue will be approximately 5%, and our reported range of growth will be at 3%.

The delta between there is divested or discontinued products, which we can talk about if you'd like a little bit more when we touch the Q&A. And we also announced that we have double-digit earnings growth per share and reaffirmed that in our press release. And again, that's also in conjunction while funding R&D at an aggressive rate. We also communicated that based on the quality of our balance sheet, many of the costs from the integration, as I'd mentioned, behind us that we've also planned to utilize a previously approved share repurchase program that had an authorization up to $225 million. And so we feel quite good about how we're positioned as we finish up 2019 and again, how we're well positioned to accelerate growth both in top line and bottom line in 2020.

And so my last slide here just kind of wraps up on something that is our beacon and our focus. Since we've laid out our strategic goals back in 2017, we're very focused on 5%-7% organic growth. In 2018 and 2019, we didn't fully get there. Why? Probably the biggest integration changes in our company history. Those are behind us, and now we see the growth within that segment to be very clear. Many of those things tied to the products that I spoke about. 70% gross margins, the combination of the mix of the new products that we're bringing in, and also the acceleration of our regenerative products. 28%-30% EBITDA margins, a goal we laid out then. We're well on track to that, which means that we'll have incremental increases here over the next three years.

Combination of the margin mix as well as other base cost initiatives. The portfolio component is an important one of those. And then double-digit adjusted EPS growth, which we've obviously reconfirmed. So some of the items here on the right-hand side, I think the Codman integration complete, as we mentioned, is a very important component, and we see growth continuing across that product line. Got a great pipeline in front of us here to take advantage of with a lot of legs on it yet over the next few years to continue to grow. I mentioned Japan and China, two markets that are growing above 20% and we think are going to continue to be big contributors in our international pipeline. And our tissue technologies investment and supply. We believe the supply component alone is going to bring incremental growth across multiple segments within tissue technologies.

I've already mentioned our margin expansion plans tied to the portfolio optimization. All that being done, many of you know we've been an acquisitive company. We plan to be focused on tuck-in acquisitions going forward. We've got the balance sheet to do it. We look forward to bringing in products here in the United States, but also now with our scale to bring in deals that might be internationally focused only as we now have this larger base. With that, I'll wrap up, and we have questions and answers, I believe, just down the hall, just across the hall. Thank you.

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