Company Name: Cardiovascular Systems, Inc. (CSII) Event: Stifel 2019 - - PDF document

Company Name: Cardiovascular Systems, Inc. (CSII) Event: Stifel 2019 Healthcare Conference Date: November 19, 2019 <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> All right. Well, good afternoon everyone. Thank you so much for attending the 2019 Stifel Healthcare Conference. My name is Mat Blackman. I’m part of the Stifel Healthcare Medtech Research Team. And today, we have Cardiovascular Systems, Inc., and Chairman, President and CEO, Scott Ward. Thank you for Scott for joining us. Scott is going to kick off with some

• pening comments, and then we could dive right into Q&A. And please don’t be shy if you guys

have questions, raise your hand and come up and thank you, Mr. Scott, the floor is yours. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> Hi, good afternoon everybody. Thanks for being here this afternoon. I’m just going to give you just a few quick opening remarks and then from there, we will go into a Q&A session. CSI is a market leader in coronary and peripheral atherectomy. We’re focused on treating patients that have complex peripheral or coronary artery disease. First quarter, we had a very good start to our year. We delivered revenue of about $64.5 million, which represented 14.5% growth over the same period the prior year. Yeah, that was our sixth straight quarter of double-digit growth. So, we have really tried to build this business to deliver a good, strong, sustainable growth over time. We’ve delivered on that mainly through a few

• strategies. One is really sustaining 10% plus growth rate in our core business, which is our U.S.

atherectomy business. We’re broadening our business to grow outside of the United States. So, we’ve launched our coronary business in Japan. We’ve launched coronary and peripheral in Asia and Pacific markets and Middle East, and we’re preparing to launch coronary in Europe this coming spring. The third major growth driver for us is really launching new products. And over the course of the past year, we’ve been launching what we considered to be interventional support devices, balloons, wires, and catheters that are used in combination with our coronary and peripheral atherectomy devices. We’ve launched most of the devices. We launched all the devices in coronary. So, over the course of the past year, we’ve launched the 1.0-millimeter Sapphire balloon, which is the smallest coronary balloon in the marketplace. We’ve launched the Teleport Microcatheter, which is the smallest Torqueable Microcatheter in the market and we’ve also just launched our nitinol coronary guidewire, the ViperWire, which is the only coronary – the only nitinol guidewire in the coronary market. That combined with some advances in our core device called GlideAssist and other advancements have really created a whole new product offering in coronary. Now, we’re in the process of doing the same thing in peripheral, and later this year, we’ll launch a full line of PTA balloons, and we’ll launch our radio toolkit that will also drive the growth of

• ur peripheral business. So, as we look forward, those are the primary growth drivers, growth in
• ur core business of 10% new expansion to new geographic markets, and then thirdly new

products. So, as we’ve projected about a year ago, we put out a five-year strategic plan, and we projected that we would deliver $435 million to $500 million of revenue by our FY2023. We’re about right

• n track to deliver that. If you think about that, that once again, is composed of a 10% CAGR in
• ur core business, about $75 million to $100 million coming from new products and about $25

million to $50 million generated from new markets. So that’s a quick overview of kind of who we are? Where our recent performance has been and then what our strategic intent is going forward? And I think from there, we’ll just take any

• questions. Can I sit by you or sit back in…

<<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> Yeah. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> All right. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> So that is actually a great intro, start looking at your reports. Now, I think about CSI started four primary components and actually, I’ll give off through a little bit more detail. So, let’s start with the base business again, that’s just the peripheral atherectomy franchises in the U.S., that’s the faster joining markets in MedTech is made just with basic level, what are the key drivers for market growth? <<Scott R. Ward, Chairman, President and Chief Executive Officer>>

• Sure. So, let’s think about first start of our peripheral market. In peripheral arterial disease, we

really face epidemic in this country. There’s probably somewhere in the order of 18 million patients that have PAD. There’s about two million that have peripheral ischemia, which is where we focus. So, we’re focusing on patients that have long and severely-calcified peripheral arterial lesions that marketplace is projected to grow and has been growing in the high single-digits. So, we had this underlying growth rate in that market of, let’s say, 8% to 9% range and that’s largely driven by the incidence of diabetes and obesity. So, unfortunate, but that is the – that’s what drives the epidemic. In the case of coronary – treatment of coronary artery disease, we focus on severely-calcified lesions. And today, probably, only about 4% to 5% of patients that have PCI are being treated for their severely- calcified patients.

If you look at that marketplace in total, probably around 15% of the patients should be cared for. So, the current penetration is 4% to 5% total addressable market, let’s say, it’s probably in that 15% range. So, there’s an opportunity, it’s probably a 3X expansion of market development for

• ur coronary business.

<<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And maybe, so at the most basic level, both of these markets are under-penetrated. My basic question is why is there a lack of clinical data? I think that’s part of it, but just help us understand how you can, for instance, take coronary from 4% to 5% penetration to maybe 3X that over the next every year? <<Scott R. Ward, Chairman, President and Chief Executive Officer>>

• Yeah. So in coronary, we have very strong medical evidence that we generated through three

different clinical trials that have been performed, but there still is a question on seeking level one medical evidence, so that is the comparison of orbital atherectomy to a balloon angioplasty for the treatment of these severely-calcified lesions. To address that, we launched a large scale clinical trial called ECLIPSE, which is we’ve enrolled about 1,100 patients in that study now. And in that trial, we’ll be comparing a balloon angioplasty to atherectomy for these severely- calcified lesions, two primary endpoints, minimum stent area, which is just are we making that lumen larger after the procedure. And then finally, targeted vessel failure, which is at one year, are we improving clinical

• utcomes? So that’s a trial that we’ll drive growth there. I think in peripheral, what’s – peripheral

is really most remarkable in that it is so fragmented. So, the care pathways there are incredibly

• fragmented. The referral patterns are fragmented and the way these patients are treated is largely
• fragmented. So, what we’ve done is, we haven’t designed and conducted clinical trials that

demonstrate that we get really strong outcomes. So, we just finished our Liberty 360 trial. We reported the three-year follow-up on that study and for Rutherford 4-5 cases; these are fairly severely affected patients. We achieved a 95% freedom from amputation and major adverse events at three years with no incremental amputations after two years. And in Rutherford 6 patients, these are patients that when they present have a large enough wound on their foot that they could be a candidate for an amputation at the time they present. We achieved an 89% freedom from amputation and major adverse events at three years. So, really strong clinical

• utcome data in a real world environment and really that that’s very important in terms of

sustaining our position in that marketplace. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And you’ve brought up the cliffs, and also we’ll just touch on it quickly. You will finish enrolling when, and you said there are two end points, one of them is an acute endpoint I mean though longer term. When might we see that endpoint in that data end would that acute endpoint do you think in and of itself without the target vessel failure data be enough to perhaps drive accelerating adoption of coronary atherectomy?

<<Scott R. Ward, Chairman, President and Chief Executive Officer>> I don’t think it will be. I think that it probably is most important part. Well, first of all, let me answer your first question. I think we would expect to complete patient enrollment in this study. By the end of this fiscal year, we expect to have about 1,500 patients enrolled. So, let’s say we complete patient enrollment in that trial, a year from now, maybe, a little bit longer than that, probably the end of the calendar year. We would then be in a position to report on those results some time in our FY 2021 or FY 2022 and then the clinical results probably in 2022. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> Okay. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> I think both of these questions are important to answer. We’ve got to be able to demonstrate for the physician that they get a good outcome from the acute procedure, but physicians also want to know that what they’re doing ultimately changes outcomes. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> Yeah. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> And that’s what really distinguishes this study from any other studies that anybody else is performing is that we have a really strong clinical endpoint that can prove not only are you getting a better MSA, but that you’re getting a better patient outcome. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And you also have safety and clients, acute safety endpoints too. I think that’s also one of the headwinds perhaps in adoption of atherectomy. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> And that is all included in the target vessel failure endpoint. It includes a MACE; it’s a composite endpoint that includes major adverse cardiac events as well. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>>

• Okay. And then just again, in general, and we’re going to talk about some of these new growth

initiatives that are accelerating growth in both of these franchises. But even before you start laying in like international expansion and these new products, you still have outgrown the U.S.

market pretty consistently. Why, I guess is sort of the short answer and how sustainable is that? And maybe, talk a little bit about the competitive environment why you’re in there? <<Scott R. Ward, Chairman, President and Chief Executive Officer>>

• Yeah. So, I think certainly this medical evidence is a key part of it. Our – we have the strongest

medical evidence in the marketplace. We also have a very large and highly-skilled distribution

• channel. So, we have 200 sales reps in the United States that support this market. We also have

about 125 clinical specialists that support cases. We cover about 70% of our cases, at least in first quarter; we covered 70% of our cases. So, we have this deep clinical acumen that we also provide support to our physicians with. We have a great core technology; really orbital atherectomy is the only technology that has a dual mode of action. We both opened the vessel and we treat the calcium in the medial portion of the vessel, because of the orbital action of our device. So really, we think about medical evidence, we have this very strong field support channel and we have a great core technology and we invest heavily in medical education. We are – we arguably provide more medical education to this marketplace than any of our competitors. And that’s because it’s what we focus on and we’re the market leaders. So as a result of, I think really, those four components are really the key drivers that help us sustain at/or above market growth. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And that’s another good segue, you brought up case coverage called out 70% this last quarter. Give some context where had that been historically? And I guess the takeaway there; this is a high-touch business. And I’m just curious as you would sort of think about the next couple of years, does that 70% need to have to go to 100%, just help you understand with that? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> Well, I think I have been targeting this kind of two thirds of our case is metric and the reason why is we compete against really big players. We compete against Boston Scientific and the coronary end market and we compete against Medtronic, Boston Scientific, and Phillips in the peripheral market. These are companies that are very large bundles. We have to compete against the bundle every day and we always have had to. The way we do it is we’re a physician preference company. We want to be standing shoulder-to-shoulder with our customers performing cases and getting great outcomes that helps us get more pull through of our support devices, but it also assures that physicians get really good outcomes when they use our products. That is an important point of differentiation in comparison to our competitors. So, at a time when they’re moving away from the cath lab, we’re moving into the cath lab. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> Got it. Are you allowed to have a rep in the procedure in an OBL or is that…

<<Scott R. Ward, Chairman, President and Chief Executive Officer>> Certainly, in the OBL, and in most hospital cases, there are some hospitals that do restrict access to the cath lab. Our sales reps are most often invited in, because they’re doing procedure support. There is a device that, in our case, the atherectomy device, it’s not an implantable device. It is done at the hands of the physician. So, the procedure support and in particular, supporting the use of that device in the room, setting the device up, making sure the techs are ready to go and doing all of that is really critically important. So, our reps play an important role in the conduct

• f those cases.

<<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> You also mentioned on this last quarter call that you’ve begun to expand that they dedicated coronary sales force; it was 20 before you’re taking it to 40. Maybe, help us understand what the role of that sales force is to begin with why you’ve carved that out and why now at the time to expand that? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> So, what we see in our marketplace, the vast majority of interventional cardiologists actually perform both coronary and peripheral procedures. Those physicians only want one sales rep. They don’t want to be called on by two different reps for whether it’s coronary or peripheral. That said, there are a number of accounts throughout the United States that are very high volume coronary accounts, who really focus on the treatment of complex coronary artery disease and the vast majority of their patients that they see have severely-calcified lesions. By dedicating reps to those accounts and to that market segment, we feel like we can not only take more share, but better position ourselves to expand the marketplace. So, that’s really what’s driving it – driving the expansion in coronary. We also are preparing for the launch of our pVAD device, which will come some years out, but we’ll be a vastly different company when that happens, because we’re not going to be an atherectomy company. We’re not even going to be a coronary artery disease company. We’re going to be a complex coronary company and we’ll be providing both support and intervention for that patient population. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And how do we think about that expansion? Is that growth sustaining? Could it accelerate growth as we think about the coronary franchise as you build out that a specialized sales force? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> We expect that that will sustain growth. I think, I think that, naturally we wouldn’t be adding reps if we didn’t think we could accelerate that coronary segment. But we’re trying to sustain growth in that low double-digit pace for our coronary business and sustaining that means you’ve got to add channel, you have to add channel strength. And so we’ll just do this as it makes sense.

We’re very selective. We only add really the addition of reps is determined at a local level based upon the local determination of demand and the ability to drive the growth of the business. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And are those reps are also helping, you said with the procedure, but case selection too, are they sitting in those offices saying, hey, there’s an – I can see calcium there that you should be doing this orbital or is it really, no, just more on the procedures for that? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> So, I would say in these larger centers that are really treating a lot of complex coronary lesions, it isn’t necessary for us to provide case planning support, because it’s a natural part of what the physicians are doing in that case. When we’re out in the community setting however and we’re supporting physicians, who are doing both coronary and peripheral, they at times, can come into a case that maybe, had no advanced CT scan or there was no advanced angio and all of a sudden they find themselves on a Friday afternoon looking at a severely-calcified patient. That’s when it’s really great to have our sales rep present and supporting that particular institution. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And maybe, talk a little bit about the new products in both the PAD and the CAD portfolios that I’m just going to call it a couple of the exchangeable platform on the peripheral side radial

• access. But help us first, maybe, introduce those products and help us understand where they fit

into the whole continuum of care. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> Well, so if you don’t mind, let me start with coronary. And over the course of the past year, we launched a series of products that I described in my opening comments that started with

• GlideAssist. So, GlideAssist is a feature in our device that allows us to spin our atherectomy

crown at about 5 RPM. And what that does is it allows that, that crown to really access lesions that are otherwise in let’s say, very tight locations. They might be following a corkscrew in an angulated lesion. By spinning that device at a really low rate, the physician can access that lesion more effectively. We then have launched the Teleport Microcatheter, which can also allow that physician to get closer to the lesion. And then we have our nitinol coronary guidewire, which has a flexible tip and allows you to access lesions that let’s say are more like an STO. So, each of those are important on their own, but when taken in combination, it really gives us a very competitive offering versus let’s say the RotoProne. So, completely renewed that coronary

• ffering. Now in a position, where we could generate probably, somewhere on the order of $800

to $1,000 more per case. Total, we wouldn’t – we don’t expect to do that in every case and we don’t expect every institution to adopt all of our support products. But if you think about the total potential, it would be about $800 to $1,000 per case. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>>

And let’s assume, give people some context what you’re generating just for an atherectomy. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> So, our every selling price in coronary right now is about $3,600. So certainly, that’s an important part of our growth plan is to increase their revenue per case in coronary. Now, we now are just now starting to do exactly the same thing in peripheral. So, we have had the radial site of

• access. An important competitive differentiator for CSI versus others is that we have the smallest

profile device on the market. We can access through a four French sheath. So, using a four and five French sheath means that we can do radial access, and we can do tibial and pedal access. Nobody else can do that. And as a result of that, that we can, like if we use pedal access, we can actually do retrograde treatment of a below-the-knee lesion, very important to not only achieve a great outcome, but be able to do it fast and efficient. So, as we look at this coming year now, we’ve launched radial and we just now have launched a product called the exchangeable device. And what exchangeable allows a physician to do is to exchange crowns during a case. So, let’s say that they would start with pedal access, you have a patient that has a lesion below the knee, they have a lesion in their fem-pop, and they have a lesion, let’s say in the SFA, where before you might only be able to treat one of those at a time. Now, you can have total leg revascularization, because you can access through the pedal artery. You can use a 1.25 crown to treat that below-the-knee lesion, you then can change out that crown, use a 20 and now treat the fem-pop lesion and the SFA, and you can get all that done in less than an hour. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And how would that compare if you were doing it one-off, one at a time? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> Most often, 95% of the time, they are only treating one level of the lesion. Now, what that does

• f course, is you still have disrupted blood flow to that foot and you have to bring that patient

back eventually to treat that. Now, to treat that as a lesion, now it would have to be more than 90 days later and these patients, especially those that have CLI are in a much more tentative state than being able to last 90 days before the next intervention. So, we charge a premium for the exchangeable device, about a 10% premium and we sell the subsequent crowns at a discount to having to purchase a full device. The physician receives a 100% payment on the first level; they treat 50% payment on the second level; and 25% payment on the third level. So, the physician is also providing great care. There’s an economic benefit for them and there’s certainly an economic benefit for us as we look at revenue per procedure. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And multilevel disease you think is – I think you said about 50% of cases, probably…

<<Scott R. Ward, Chairman, President and Chief Executive Officer>>

• Yeah. All the time, I think it could become probably 50% of our hospital segment business,

which is where these more complex patients are principally being treated. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And where are you on the rollout with exchange? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> Just launched it. So, we launched that device in September and it’s still quite early days. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And is this like a typical med tech multi-quarter type launch, it takes time for these sort of gain traction or if we didn’t get enough out in the field or maybe we could start seeing some sort of benefit in the next couple of quarters. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> No, I think we’ll start seeing benefit of this more quickly than that, because this is a known

• entity. Where we have work to do is training an education of physicians on how to use the device

and also really how do you do these alternate sites of access. So, all of this really is unique core competitive advantage for CSI, the only ones with a total leg revascularization. We are the only

• nes who have this exchangeable type of device and the only ones, who can access through the

pedal artery. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And then maybe, just to wrap on the base franchises, talk a little bit about the competitive environment, you compete against some larger – much larger players and some smaller upstart

• folks. So, just maybe, give us a couple of minutes on the state of the competitive landscape. And

then I think the last point, two points to add, I’ll just throw it out there and ask you about the drug coated balloon tailwind. And I guess the most recent clinical trial data in coronary that maybe, some folks are concerned about an impact on stenting procedures, the ischemia trial and what your – what your views are on that? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> So, a competitive dynamic really hasn’t changed our market. Our competitive dynamic has been fairly stable for quite a period of time. We compete, as I said earlier, against very large players. In coronary, we compete against Boston Scientific. We probably have 55% revenue share and mid-30s in terms of unit share. They rote approach has been around for a very long time and as a result, a lot of physicians during their fellowship training over the course of the past 20 plus

years were trained and educated on rotational atherectomy. So, our job is to get out, and train and educate new accounts and then support those accounts, make sure they get great outcomes. In the case of the peripheral, we compete against Medtronic, Boston Scientific and Phillips, all three very big players. And we probably have high-30% market share. Medtronic probably in that low-30s, high-20s, Boston scientific in the low-20s and then Phillips, let’s say, and the teams in Phillips with the lasers mainly focused on independent recent analysis. So, we include them in that bundle, but that’s really where that laser is largely being used. So that’s a very standard dynamic of course, I’m going to start up coming into the marketplace as

• Shockwave. Shockwave has largely been focused on treatment of the iliac arteries, which is an

area that we really don’t participate in, and we haven’t seen them too much in the rest of our peripheral market. They’ll be launching apparently below the knee here soon and that is a device that we could very – we should very effectively compete against. Average lesion length below the knee is about 90 mm. As I said, we can treat that type of lesion in about three to five minutes using one device. Average selling price is about $2,600. If you want to treat that same 90 mm lesion using a Shockwave balloon, you’ll have to use three balloons, because they can treat 30 mm segments at a time per balloon and it will probably take you 20 to 25 minutes. Now, there is no medical evidence necessarily to support the use of their device below the knee. There’s really no incremental reimbursement for that. It’s not atherectomy, it’s a balloon and frankly, the device is much more difficult to use. So, I feel we match up pretty well against them and we should be able to compete effectively against Shockwave in that segment. Ischemia, the ischemia data was released at AHA. This was a study that compared stents versus medical management in patients that have stable coronary artery disease. These are patients that have some angina, but it’s stable angina. And the results of that trial demonstrated that while there was improvements in quality of life and perhaps a signal towards a reduction in mortality and MI related to stents late largely the two proved to be about equivalent. That is a patient population that once again is stable and presents with a lower burden of disease. Our patient population is the patient population that has multi-vessel disease, usually – always severely- calcified, usually multi-vessel and oftentimes involving the left main artery. So, we treat a much more complex patient population and the results of ischemia. We’re never really going to read on

• ur applications in any case. The DCB, I’m doing pretty good remembering you had a lot of…

<<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> That’s really impressive. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> The DCB tailwind historically, physicians prior to the introduction of drug-coated balloons, physicians were trained to access the lesion, debulk lesion, balloon it to get the largest lumen possible and to try to get in and out without causing a dissection and without leaving anything

• behind. If they could avoid using a stent, that would be the best outcome. Along come drug-

coated balloons and anti-restenotic option, so that now they could do all the same procedure but

they have a device that they can use to prevent restenosis in the long run and you see an adoption

• f drug-coated balloons.

Now along comes the Katsanos review that demonstrates that there seems to be a signal for an increased rate of mortality related to paclitaxel drug-coated balloons. Personally, I don’t know if that’s really there, but nonetheless, the FDA has chosen to implement a series of warning letters regarding this and causing physicians to have informed consent prior to the use of a drug-coated

• balloon. That requirement, which started in the March timeframe, caused some physicians, who

were trained originally on debulking lesions effectively and they nothing left behind the concept to return to their original source of practice. So for us, that created what we think is a small tailwind that is related to the hospital segment of

• ur business that is above the knee, represents about 30% of our peripheral revenue, at about

20% of our overall revenue. So, a small tailwind there, we think as we move towards the annualization, that probably started in March of last year, because there’s a strong underlying growth rate in this marketplace anyway. We think, we’ll probably move past that without much impact and the benefit that we’re seeing is slight, but it’s real and it’s there, and it’s because physicians are just going back to standard of care and the best available practice for debulking these lesions. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>>

• Okay. We got about 32 seconds left. So, let me just quickly end on the pipeline. You’ve got a

very interesting intermediate and longer term pipeline. I’m just going to call out the circulatory support pump and maybe, in the 16 seconds that remain, where are you in the development of that product, where are the points of differentiation and when could we expect some commercial? <<Scott R. Ward, Chairman, President and Chief Executive Officer>> So we’ve completed our third pre-sub meeting with the FDA for our IDE. We’re expecting our first-in-human experience with this in our fiscal year 2021, which will be about a year plus from now. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> Okay. <<Scott R. Ward, Chairman, President and Chief Executive Officer>> But progressing very well in animal trials and verification and validation testing. <<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>> And that’s a very large incremental opportunity for you.

<<Scott R. Ward, Chairman, President and Chief Executive Officer>>

• Yeah. We get upside, of course.

<<Mathew Blackman, Analyst, Stifel, Nicolaus & Company, Inc.>>

• Okay. Well thank you very much, Scott. Appreciate it. Thank you everyone for attending.

<<Scott R. Ward, Chairman, President and Chief Executive Officer>> Thanks, Matt. Thanks for all the support. Appreciate that. Thank you.