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Glaukos Corp (GKOS) FY 2021 Earnings Call Transcript | The Motley Fool

Glaukos Corp ( GKOS -3.28% )
FY 2021 Earnings Call
Nov 29, 2021, 3:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Chris CooleyAnalyst

Well, good afternoon, everyone. I’m Chris Cooley. I’m the Senior Medical Device Analyst here at Stephens. I’d like to thank you all for joining us here today for our virtual conference today. We hope to see all of you live with us in Nashville starting off this Wednesday and running through Friday. But for those that can’t join us then, we have a great lineup today and I can think of no better way to round out the medical device track today than closing with Glaukos Corporation.

Today, we’re honored to have Chris Calcaterra, the Company’s Chief Operating Officer; and Joe Gilliam, the Company’s Chief Financial Officer and Senior Vice President of Corporate Development; as well as Chris Lewis, the Senior Director of Investor Relations and Corporate Strategy and Development joining us from the Company.

Gentlemen, I just want to say thank you so much for joining us here right after the Thanksgiving Holiday. We really appreciate you being with us and being a part of this virtually.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Thanks for having us, Chris.

Chris CooleyAnalyst

Sure.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Appreciate the opportunity.

Questions and Answers:

Chris CooleyStephens Inc. — Analyst

Well, just as a quick reminder too, before we get started. I’m going to start off with just a few questions, but we’d love to have this as interactive of a discussion as possible. So it’s value-added for you as well. So if you have questions, feel free to either raise your hand there via the chat and we’ll get you called on or alternatively if you prefer, you can email me here at [email protected], and I’m happy to ask those questions for you anonymously.

So gents, let’s get started here with the obligatory COVID question. During the most recent third quarter call, the Company indicated that COVID-19 does continue to create some volatility and headwinds globally, but you saw improvement. I think you characterized it as encouraging in July and August. Since then we’ve seen Australia lockdown, we’ve talked about some limitations now in New York potentially on elective surgeries and obviously, over the weekend, we had the Omicron variant raise its head. I’m assuming we’ll take Omicron off the table. You weren’t exhuming that here in the back half of the year, but overall, is this kind of the general — what level of activity that you assumed when you contemplated the fourth quarter and then looking into calendar 2022, just from a COVID perspective?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Sure, Chris, thanks for the question. I — when we look back, similar to most companies I think across the medtech and healthcare space, we saw the impact over the course of later July, August through a variety of markets globally, and we did see a somewhat more encouraging trend in September and October emerge. When we went into our third quarter earnings call, what we said was the assumptions we’re making for the remainder of the year are a degree of conservatism around COVID. We didn’t know whether it would be the Delta variant or now this latest Omicron variant. But we sort of made the assumption that to a degree, similar to what we saw last year, where September and October were a little stronger followed by a bit of weakness in November and December, that we may see a little bit of that again, right? Vaccination rates help mute some of that, but the reality is we continue to have a bit of an unknown as we enter into the winter months in the Northern Hemisphere. So, we try to factor that in. I guess, we’ll see what this latest variant has in store for us in terms of lockdowns or shutdowns in different geographies. But we certainly did try to incorporate some of that thinking into how we thought about the remainder of the year.

Chris CooleyStephens Inc. — Analyst

And maybe just to level set the room just to make sure we’re on the same page. When we think about the Company’s businesses, both in terms of complex cataract on the glaucoma side with MIGS, as well as the corneal front, one more susceptible or less susceptible to the impact of COVID here in the United States, just generally speaking?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Both susceptible, but if you look back at the depth of the lockdowns and shutdowns in 2020, the US glaucoma franchise was clearly more impacted. I think we troughed in that business at down around 97% when everything was shutdown, whereas in the corneal health side of things in the US, we were — we troughed at around down 75%, 80%. So, meaningful, both of which can be deferred for a period of time when forced to do so. But the impact seems to be a bit greater in the glaucoma side.

Chris CooleyStephens Inc. — Analyst

Understood. Well, let’s shift gears to the competitive front and let’s start with MIGS. Obviously, Alcon recently announced their intent to acquire Ivantis. Modest purchase price of $465 million plus some undisclosed milestones. So I really want to start here with the fact that Hydrus has been in the market for about four years approximately. I’m curious if you think this is a known and well-understood technology, both not only within the glaucoma community, but also within the comprehensive ophthalmology space. And why or why not? I guess, really what I’m trying to get at here is, is there some wood to chop from Alcon’s perspective to really get — raise awareness and drive utilization or is this something that’s a technology, which you think has already kind of semi-embedded by the marketplace?

Chris M. CalcaterraChief Operating Officer

Chris, I would say that it’s a technology that is certainly understood and doctors are well aware of. It did — it was launched in, I would say — excuse me, August of 2018. We have paved the way with trabecular bypass with the introduction of iStent in 2012 and then subsequent to that iStent inject and iStent inject W. I think you also had Alcon purchasing CyPass. So MIGS is certainly now certainly now a category that’s understood and that people accept and that doctors, for the most part, are trying, are utilizing. So we created the category and people are well aware of the Hydrus product. The advantage of Alcon taking this over for them is that, they have a much bigger voice and a much bigger presence and a much bigger promotional budget. So, I would expect that they will be promoting this quite a bit. Hopefully that all high tides — boats rise with the high tide with the — of them promoting and talking about trabecular bypass and the advantages of trabecular bypass versus some of the other technologies, tissue disruptive technologies that are out there. So I think awareness is there, but I still think there is an opportunity for the category to grow by having a player like Alcon involved with this technology.

Chris CooleyStephens Inc. — Analyst

Let me just follow up to that briefly and to your point, I think there is a good bit of angst on the part of the Street right now just as to how first half of next year will shape up, there is a number of variables here. Obviously, the change in the pro fee, the close of this — or the anticipated close of this acquisition. So, maybe if we just look at the latter part of that, do you think this is something that as we kind of get through the first half of the year, we can start to discern whether there is an ability for, to use your analogy, all boats rise with the tide here and we’re seeing the category grow or accelerate? Or is this something that probably takes maybe longer to play through, just in terms of understanding the impact of Alcon owning Hydrus or Ivantis, excuse me?

Chris M. CalcaterraChief Operating Officer

I think it will take time. I think it’s more of the latter that it’ll take time to figure out the impact it will have. But I do believe that with the attention that Alcon certainly going to have on the Hydrus and trabecular bypass that it will help to grow the category. We haven’t — Joe hasn’t or nor have I defined that and we’re not prepared to be able to get into specifics around that. But that’s how I view it at least that with a player like Alcon in here too [Phonetic] which we have great respect for, I believe that this will bring more attention to advantages of trabecular bypass. I would say, for us, the fact that we’re continuing to expand our bag with different products, including hopefully PreserFlo and iPRIME and infinite, in the not too distant future, that that will help us in terms of being able to go to accounts into physicians, into ASCs and hospitals with a fulsome product offering that they’ll be able to purchase those products from us in a one-stop type of purchasing option.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Hey, Chris, I’ll just add. I think it will be difficult to isolate that single variable, right? I mean, the reality is, is that, that’s one piece of an evolving landscape, both from a competitive standpoint, product offerings, COVID as we are talking about, right? What that does or doesn’t do to the underlying market in the course of a single quarter or even the year. And then ultimately, as Chris was alluding to, us moving beyond combo cataract MIGS into a much larger pool of opportunity with the various products that we hope to bring to market in 2022. So, I think there will just be — there’ll be a series of puts and takes, and it will be hard to isolate that one specificity.

Chris CooleyStephens Inc. — Analyst

Good. Maybe one final question on this front before we move forward. Chris, I know you remember the early days of LASIK very, very well and we talked about the pros and cons of multiple systems and then the consumers heard the pros and cons of multiple systems out there. Alcon has come out with an initial message of safety, when we think about the Ivantis’ story. And so, when we look at it from a relative efficacy standpoint, two devices versus the original iStent are essentially the same 77% versus 76% when we look at the trial data, but when we think about hyphema, in particular, it’s almost 4x higher, when you sort of — the raw data from the trials or Ivantis and the Hydrus. I’m just kind of curious how you think this message stacks up in the end marketplace. And do we — are we potentially at risk? It seems something much like we saw in the early days of LASIK where there is concern or there is noise in the end marketplace by the surgeon, which device do I use, which is more efficacious, which is the safest device for myself to use? I’m assuming that’s going to vary a little bit by the glaucoma surgeon versus the comprehensive ophthalmologist but would love to hear your thoughts there.

Chris M. CalcaterraChief Operating Officer

Yeah. There’s a lot in there, Chris.

Chris CooleyStephens Inc. — Analyst

Sorry. Let’s break it up.

Chris M. CalcaterraChief Operating Officer

Yeah, yeah, I’ll break it up. I am in agreement with you that from an efficacy standpoint, very, very similar. We feel very good about our efficacy both in our pivotal and with the real world data that’s been out there. We’ve got over 20,000 stents out there in study eyes [Phonetic]. We’ve got papers that now go back 20 years. And we have over 100 published articles and a lot of the real world data that’s coming out here, there was recently in ARVO, really shows the benefits of iStents from both an efficacy and a safety standpoint over Hydrus. You mentioned hyphema, there was independent paper by Wills, very reputable institution that showed a hyphema rate of I think 11% for us and 42% for Hydrus. That’s significant when you consider that this is being done in accommodation with cataract surgery and cataract surgery is the primary objective of that is for a good visualization as soon as possible.

Chris CooleyStephens Inc. — Analyst

Right.

Chris M. CalcaterraChief Operating Officer

And when you have hyphemas, that is difficult to get that kind of outcome. So we look at that as a big benefit. I think to your seeing — well, you saw it in the pivotal, there was a big difference. And PAS, peripheral anterior synechiae, where in their study, their pivotal, I think it was at a 19% versus our 1.8% and there is other independent studies out there that shows high as 30%. So, I believe that the majority of people out there see the iStent inject W is the safest alternative when it comes to trabecular bypass and that that’s a big advantage for us. It’s the most micro-invasive technology out there for trabecular bypass, there is fewer challenges associated with AEs, as it relates to our product versus the Hydrus.

Chris CooleyStephens Inc. — Analyst

Great answer. Maybe Joe, help me with maybe one other quickie here. When you just think about the pro fee, in particular or Chris, if you want to opine on this as well. I’m sorry to exclude you there. But I think first and foremost, maybe help us level set when we think about what percentage of the business is actually impacted directly by these changes or proposed changes in the pro fee from CMS? And what percentage, obviously, didn’t goes through the ASC when we think about just the MIGS? And then against that, there was a lot of discussion on the Street, when we think about why wouldn’t a profit-minded surgeon maybe pursue goniotomy instead or use GAP [Phonetic], what are kind of my restricting factors there if — on that front?

So two-part question. One, what’s my exposure, if I’m really worried about the pro fee being cut to approximately $135? And then two, help me think about why I wouldn’t just do one versus the other from just a pure profit perspective?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Let me start, Chris and then you can…

Chris M. CalcaterraChief Operating Officer

Yeah. I’ve got a lot. I can answer that, Joe. Why don’t you start?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Yeah. You can add on the second part of his question.

Chris M. CalcaterraChief Operating Officer

Yeah.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Okay. So first in terms of the numbers, Chris, let me start very high level. US glaucoma business is roughly 60% of our overall revenues currently. Within that, in the US, about 80% — 75% to 80% of the procedures are done in Medicare patients. So that’s who we were talking about with the professional fee changes that have been made. So I would — we would say, first and foremost, all of those are a consideration, whether they’re doing it at the site, at the hospital, or whether they’re doing it in the ASC, professional fee consideration is one that plays that plays in both sides of that. So about 80% of the overall procedure volume in the US is Medicare-based. Chris, I don’t know if you want to talk about the dynamics around that relative to the other procedures.

Chris M. CalcaterraChief Operating Officer

Yeah. I think, Chris, your point was why wouldn’t doctors go to more profitable procedures where they make more in the pro fee and so forth. I’d like to believe that most doctors will pick their technologies that they utilize for mild-to-moderate glaucoma in combination with cataract surgery based on what’s best for the patient. And things such as goniotomy, while there is more, certainly, more profit available that’s a procedure that is disruptive. It strips the TM, it breaks down the blood-aqueous barrier, it’s a procedure that’s been around for over 100 years and it creates a lot of hyphema as you would expect. It reduces the ability to do other technologies down the road. The Schlemm’s canal serves to pump fluid through the canal, it’s an organism that moves fluid in and out. When you strip the TM, you lose that function. I’d like to believe that most surgeons will look beyond the profitability of that procedure and focus on what’s best for the patient. You’re always going to have some doctors that are profit-motivated and they can convince themselves that that’s the best procedure for the patient. But in my mind, trabecular bypass is the way to go, and I believe that that will prevail with most of the surgeons long term.

Chris CooleyStephens Inc. — Analyst

That’s a great color. I appreciate that. So let’s take a little bit about next year’s outlook. Right now, in Street consensus and I know our model as well, all have Glaukos declining year-over-year in terms of total revenue on the top line. And when we see that a number of investors that we speak with just the start site not interested, it’s a non-starter when I think about that kind of year-over-year decline. I know you don’t have formal guidance for 2022 yet and we won’t get that till next year. But help me just think a little bit about kind of the potential catalysts and risks as I look ahead to 2022 relative to consensus? And maybe if we do that, let’s maybe just think about the big ticket items first, let’s think about procedure volume, pricing of these devices, and also a regulatory — potential regulatory timing as well. So let’s kind of maybe rank order these in terms of their respective impacts. I’m assuming it’s going to be volume first. So let’s maybe talk about procedure volume and the pros and cons there relative to expectations just based on COVID and also the change in the pro fee.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

A lot in that, Chris, I’ll try to do a justice as I make my way through it. First, I think to that investor who maybe is less than willing to take a look at it, I would point to two things. The first being the pipeline, which I know I’m sure we’ll get to here in a bit and the long-term opportunity associated with Glaukos, the significant investments we’ve been making for some time to drive long-term value creation here.

Second, I think before — when we talk about the puts and takes, let’s start with what should be hopefully continued strong performance, COVID aside in our corneal health and international glaucoma franchises. And so, what we’re really talking about here then is largely the US glaucoma franchise in that context of your question and what’s going on there. And within that, what I’ve said is, this is one of those environments where there are enough moving parts that the bell curve of outcomes is a little wider and a little flatter than typically when we look at these situations. What I mean by that is, when investors ask me why not this? Why not this number for next year? Why not that number? I can’t necessarily argue against those on either direction. The reality is that there is a wide band of potential outcomes as we think about next year and what’s driving that. Well, as you said, again, setting aside COVID because I think that’s a broader macro fee, what impact does the pro fee reduction have on the utilization of trabecular bypass? What strategies will we or when Alcon owns Ivantis do to mitigate that, right? What FDA approvals will we achieve to help both supplement our existing core offerings, as well as move us into a much broader category of stand-alone surgery, in particular, late-stage surgery with PreserFlo and iStent infinite?

From a pricing standpoint, obviously, we were pleased with where the facility fee came in after the revisions in the final rule. So we’ll have to see how that plays out in the context of the overall competitive dynamics. So, I think there is a number of variables in play there, depending upon how your diligence, if you will, pans out between now and early next year, you could draw very different conclusions on what 2022 may look like. From our standpoint, we’re busy doing the work, right? We’re doing our own analysis. We’re doing our own analytics. We’re doing our own assessments of what we think can or will or will not play out, and we want to see some of that execution because there’s a lot there, and I want to see that execution before we start putting a number behind it for investors to coalesce around. So hopefully, I covered most of what you were asking in that question, Chris.

Chris CooleyStephens Inc. — Analyst

I think it was a great point. So maybe just unpack that a little bit and summarize it, it sounds like, while we and the Street, at large, are basically modeling a decline year, there is clearly catalyst which exists or potential catalysts, I should say, which exists, which could maybe make a different outlook there — quite feasible as we play through the year.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

I think that’s fair. And quite frankly, we want to see it emerge as well given the number of things that we’re trying to execute on, as well as the variables that are facing the market overall. So, we’ll continue to be conservative as we think about that from a public standpoint and continue to try to execute toward something that looks much better.

Chris CooleyStephens Inc. — Analyst

Super. Let’s switch gears maybe to the corneal franchise for just a moment. I can remember back, I guess, that’s 1st of August when — of 2019, when you guys acquired Avedro, you talked about a $3 billion potential TAM at the time. And, of course, you had Photrexa with orphan drug status through 2030. If you fast forward to present, integration was gone, I think, extremely well, especially considering COVID-19 and the growth has been impressive. So, I guess, my question is, how do you further develop the market opportunity just for keratoconus first coming out of COVID? And then I want to kind of get an update just in terms of Epi-on and then how that can potentially extend the orphan drug status there when we think about CXL therapy? So just, coming out of COVID, how do you continue to drive awareness and adoption, we’ll just — when we think about just the COVID — I mean, sorry, the keratoconus opportunity?

Chris M. CalcaterraChief Operating Officer

I’ll take that part, Joe.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Do you want to start, Chris?

Chris M. CalcaterraChief Operating Officer

Yeah.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Okay.

Chris M. CalcaterraChief Operating Officer

So in terms of — to your question, creating awareness and growing the market, there are so many different strategies that we’ve initiated that in combination with each other have helped to grow their business and during a difficult time, COVID time. And they really center around early diagnosis at the optometry level and we’ve approached that with different strategies from going to their congresses and their meetings to digital presence to geo-marketing within specific areas to calling on optometrists to webinars, etc. We’ve put a lot of resources behind education with optometry so that they diagnose this earlier. Many, many times, they were diagnosing this as progressive myopia versus keratoconus. So there is that initiative.

And then part two is, once it’s diagnosed, getting those patients funneled into practices who have our iLink technology. So we’re helping with the referral patterns to get them into our practices to do the procedure to — then other areas is getting doctors — more doctors involved with the iLink procedure and making the capital equipment no longer an impediment to entering into this category. So we’ve done a lot of things, and we’re going to continue to do those and build on those strategies and continue to execute around the strategies so that we can continue to build this business, to increase the awareness, to increase the number of procedures that are being done because there is a need for it. And right now, we believe strongly that there is a lot more cases of keratoconus out there that are being — that are being — that are not being diagnosed. And so, we’ll continue those strategies.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

I think I would add to that. So, I think Chris framed it right in that — to date, so I think [Phonetic] aside, again, COVID an impact that had on sort of executing on some of the strategies. Maybe think about it, we closed this in November 2019. We had our first sales meeting with the combined organization in February. Thankfully, it was in February and then the world changed a bit in March, right? And so, to date, I think we’ve done a terrific job on the first leg of that growth story, which is opening up doors, getting organized, putting in the seeds for a lot of things Chris is talking about and ultimately, now as we move forward, we’ll continue to open up doors. But I think a lot of it comes into what Chris is talking about in terms of early diagnosis, education and awareness and these things that we’ve been doing but we’ll continue to put more and more investment behind to help drive that diagnosis and those referral patterns to get these patients taken care of and identified as a part of the process. That’s going to be essential for us in the years ahead.

Chris CooleyStephens Inc. — Analyst

Got it. And then maybe just with broad strokes here, when we think about at Epi-on in the future, I know our research and I think many others as well, all have come back kind of with a conclusion that surgeons very excited about having the opportunity to perform this procedure Epi-on versus Epi-off. I’m not saying that it gates the adoption right now but certainly, they’d be a lot more interested in it as an Epi-on type procedure. So as we think about the trial there in that moving forward, can you just give us an update there from timing? And then kind of as a quick follow-on, I think all of us think about it from an adoption perspective, but is this also a capital opportunity as well? Is there an upgrade cycle here on the systems, in the future or is this just a pricing for Photrexa coming in under the procedure as it stands today and maybe just broader use? Help us think about that.

Chris M. CalcaterraChief Operating Officer

Joe, why don’t you start, then I’ll add to it?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Okay. Well, first, no change to what we’ve said historically around the timing there. That’s a 2022 submission, 2023 approval around Epi-on is our expectation. The gating item there is obviously not the conclusion of the clinical trial, but the shift that we made from a CMO perspective to support the business successful commercial launch. That’s first and foremost.

As we think about the revenue opportunity associated with this, I think it has more to do with some of what Chris was saying earlier around opening up the patient population, surgeons feeling confident in intervening perhaps a bit more prophylactic lead for patients than they would have possibly before in waiting to do the Epi-off procedure. And I wouldn’t necessarily call out, Chris, the device upgrade capital cycle as a meaningful revenue driver. As you’ve seen in our hands, our strategy has been to take the capital equipment piece as much out of the equation as we can because this is really about driving adoption of the technology in the procedure and getting that pull-through that it is about the initial outlay. So we’ll do everything we can to make that not an impediment as we go through the conversion to Epi-on for these surgeons.

Chris M. CalcaterraChief Operating Officer

Yeah. I was going to talk about the capital equipment as well, Chris, that actually, we’re going to want to make it as easy of a transition for our existing customers as possible. It is a separate piece of equipment, but we’re not looking at it as an opportunity, a big opportunity for revenue. We’re running it to make it convenient for our customers.

I do think, to answer another part of your question, that Epi-on will be an inflection point around this procedure, patients are educated, doctors are educated around the advantages of Epi-on in terms of the healing being quicker and the pain being less with the procedure. So, I think it will be an inflection point. I think it’d be a great opportunity to continue to expand the market.

Chris CooleyStephens Inc. — Analyst

I agree. Look forward to seeing that move forward. Let’s talk a little bit more about the pipeline, because I mean, I think that’s clearly, not only a huge potential driver for growth going forward, but it’s also pretty transformative when we think about from once the Company has come been originally just to MIGS device, which has been obviously revolutionary but you have iDose coming up, iDose TR, we have iPRIME, we have infinite, and we have PreserFlo. Hopefully, I’m not leaving anything else out since we already touched on Epi-on here just in the near term, plus we have a number of other I know pharmaceuticals that are under development as well. So, all of these really in and of themselves can change the growth in the margin profile of the business. So if we could maybe just start with iDose, still on track for an NDA submission in 2022 approval, I’m assuming in 2023, no change in those timelines, but I’m curious, just more so from your perspective, what do you need to see on a relative basis versus bimatoprost to have a huge commercial success here? What do you think the two key ingredients are or the single ingredient that you have to demonstrate to have commercial success?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

First, Chris, nothing has changed, right? We — I think we gave an update on the third quarter call that we’re talking about a late 2022 submission, hopefully, 2023 approval around iDose. And I’m not sure if things have changed much in the context of the way we position what success would look like or what is required. I think back to the earliest days that Tom talked about iDose and pretty consistently, we said it’s a three-month endpoint for FDA approval. But the reality is, we felt like we needed six months of efficacy to have a product and if you got to a year and beyond, it started to look like a pretty good product, right, if not great.

And then, obviously, we’ve been encouraged by the data we’ve shown thus far in the Phase 2 study and we hope that that translates into similar, if not, better data as we think about the pivotal and then ultimately, obviously, the real world results. I mean, the idea that a patient could — instead of taking multiple drops a day, have a single injection that could last multiple years is a pretty compelling value proposition relative to all therapies, including DURYSTA or other bimatoprost delivery systems.

Chris CooleyStephens Inc. — Analyst

Got it. Can we maybe switch gears to PRIME then to iPRIME? No formal timeline really that I’m aware of at this point, it’s been provided on that technology. Should we think about omni as the appropriate predicate here? And should we need to see head-to-head? Or is there another known control that we should think about when we’re thinking about the development of this? And I know you updated us on the conference call. But I’ll push once again here on our fireside when could we maybe expect to see some updates as to the regulatory timeline for iPRIME?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Sure. Well, I think first, really the area itself was first developed over 20 years ago, right, by — the company’s name has changed a few times, but it’s the iTrack procedure, it’s been out there and it’s undergone various changes throughout time. In the context of iPRIME, we are in late-stage development as we’ve said. And ultimately, all I’ll really say on this is that, we’re committed to pursuing truly micro-invasive procedures. We think that’s the right thing, you heard Chris say this earlier, we think it’s the right thing for patients for their long-term care. And so, our focus and approach with iPRIME is to make sure that we’re delivering on our promise of something that’s truly minimally invasive.

Chris CooleyStephens Inc. — Analyst

Great. And then maybe similarly on just on infinite, I know a number of us were initially very focused on PreserFlo, you had much stronger results and I think all at large had anticipated with infinite. And so, now, if we think about this kind of refractory population, help us think a little bit more about positioning once both — assuming both are approved between both infinite and PreserFlo, how do I think about that patient as they come through the continuum where the two devices fall? Is PreserFlo really just a replacement, essentially for XEN and I see infinite earlier stage, or do I think about them maybe equally — early on — earlier stage in terms of adoption?

Chris M. CalcaterraChief Operating Officer

I’ll take that, Joe. I think, first of all, we got to wait for the label — labels, excuse me. But I think as you do your research and you talk to ophthalmologists, I think, to your point, Chris, people were really pleased with the data that came out of the infinite study. We have really good results with really sick eyes. And I think doctors will see this as an opportunity to try one more thing, trabecular bypass, iStent infinite prior to moving to a more invasive surgery and have external procedure, whether it’d be a trab or PreserFlo or some other type of shunt. They want to give it give it one more try before they get to that place where they have to put — doing invasive procedure, cutting back to conj [Phonetic], opening up the eye and placing a device or putting — or doing a trabeculectomy. So I think there is a natural separation positioning that will take place that we will advocate for that PreserFlo, there’s always going to be a need for that type of procedure for those end-stage therapy but the infinite fits nicely right before that. And who knows where it goes from there. And again, we’ll have to see what the labels are but that’s how I see the product being utilized — products, excuse me.

Chris CooleyStephens Inc. — Analyst

Understood. And if we think about longer-term, I mean, I realize we can’t quantify this today, but you have dry eye, AMD, uveitis and even presbyopia, all in the proverbial pipeline here and multiple shots on goal. As a device analyst, I know I don’t include these in my potential upside scenarios or valuation scenarios at present, I’ll be [Phonetic] should. So I want to give you the opportunity to say what would you highlight when you think about these opportunities? I think we’ve all can size these markets. But what can you highlight in terms of what you have in the pipeline today that should give us some confidence in giving you credit for this pipeline’s potential, not to be condescending in that or adversarial, the way we phrase that but these are really big markets and sure, it would be great if you execute it? But what can you point to that should give us some early stage confidence that what you have in the development has a pretty good shot at being a commercial success?

Chris M. CalcaterraChief Operating Officer

Joe?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Well, first, I’m not even sure folks have even included all of our device pipeline yet in their numbers, let alone the drug side. And that’s OK because I think ultimately what matters is how we execute and the runs we’ve put on the board over time. So we’re understanding of that, we’re playing this for the long-term and not necessarily the next quarter or two. But as we think about the next even 12 months, if you take a step back and we’ve already talked about potentially multiple new product approvals and introductions if they happen, but we also expect to submit two NDAs. We expect, as we’ve said publicly, to advance at least three pharmaceutical drug candidates in the clinical trials. That’s a pretty significant sea change in the context of the Glaukos of old to the Glaukos of new, right? And it starts to become much more real I think for folks during that timeframe.

So, we’re preparing to do what you might expect as that becomes more real, we will start doing more education, right? We’ll provide a bit more of that information that you’re looking for around how to think about the positioning, how to think about the opportunity, how to think about the rationale behind why we’re proceeding with these particular candidates and shots on goal. But what I can say behind the scenes is that, the same thing and the same mentality that drove us to pioneer or innovate in MIGS is driving our thinking in these other categories. If you notice what we’re really doing is taking differentiated approaches, they may not all work. We’re OK with that, right? What we’re trying to do is take meaningfully differentiated shots on goal here and see if we can make a difference, and time will tell. And between now and then, we’ll do a little bit more in terms of educating investors to make up their own minds on multiple of these candidates.

Chris CooleyStephens Inc. — Analyst

Makes perfect sense. Maybe one last one for me, I want to make sure you guys have some time for concluding remarks. But just when we think a little bit about the Company going forward and you touched one of this then, potentially transformative, not all will hit, but some of these opportunities likely will, to some varying degree of partial success. So, if we think about Glaukos longer-term, say, three years, five years from now, how important is glaucoma or what percentage is glaucoma of this business versus maybe cornea and these other opportunities longer-term? I’m assuming this business materially evolves, but how would you characterize that?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Well, a little bit depends, Chris, on how far out you look, right? And glaucoma will always be a meaningful part of our portfolio both because of the products we have today, but also what we expect to bring forward in the coming years, including iDose and successive generations of that technology and others around it. But you can’t ignore the size of the markets — the already established size of the markets that we’re going after with some of the other pipeline products. The reality is, is that, if you had a hit in just one of these, right, whether it was dry eye or whether it was presbyopia or whether it was one of the AMD or retina conditions, any one of those could end up potentially dwarfing the existing glaucoma franchise. So, we’re preparing to build franchises in each of the three main areas, glaucoma, corneal health and retina. And I can say that if we’re successful in half of these, we’ll be a fundamentally different Company in the coming years, whether you measure that in three-, five- or 10-year period — time periods.

Chris CooleyStephens Inc. — Analyst

And I’ll fit [Phonetic] and just squeeze one other quick one in here. Can you just update us again, I think this is important to highlight as well, just when you think about the R&D line, and what’s in-house now in terms of headcount and expertise? How has the bench evolved, just in terms of, not only number of individuals they’re supporting that R&D function, but just in terms of where their skill sets lie?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

I would say, Chris, it’s been nothing short of a complete transformation in terms of our capabilities over the last, I don’t know, three, four, five years. I mean, a lot of these things were happening in some form, seeded prior to that but they’ve really accelerated in the last three to five years. Over the last three years alone, we’ve self-funded over $259 million worth of R&D, $250 million. We’ve expanded our headcount in virtually every area of R&D from pilot operations through to original sort of core development quality around that, regulatory around that, clinical around that. Now, I would say a significant percentage as you might expect a bit on the pharmaceutical side, probably the majority, actually, I — for sure, the majority have been on the pharmaceutical side of that and we’ve been really fortunate attracting world-class people throughout the organization. I mean, it’s well over 50 people now that are working on various aspects of our pharmaceutical development and that continues to grow every day. So, I’d say, we continue to serve, really put a lot of fuel in that [Indecipherable].

Chris CooleyStephens Inc. — Analyst

Super. Well, gentlemen, this has been great today. I want to be good to my word and give you the final say here. So, Chris and Joe, what would you leave us with today when we think about the Glaukos story? How — what should be our key takeaways?

Chris M. CalcaterraChief Operating Officer

Joe?

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

So I think it’s a little bit of an extension of what I was just saying. I think the reality of our businesses that we’re in a pretty transformational period of time. It’s not something and while investors may start to focus on it more over the next 12 and 24 months, the reality is it’s been a long time coming in terms of investments we’ve been making behind the scenes in building the business. Building the business both for the near-term, right, in terms of 2022, but also the long-term in terms of the shots on goal that we hope to take forward here over the coming months.

So, we’ve established a pretty good track record. I think of self-funding our ambitions and they’re pretty grand ambitions. And ultimately, we hope to commercialize these in what we think is a pretty leverageable commercial channel and we like ophthalmology, not just because it’s an area that some of us, in the case of Chris and Tom, have spent their entire careers, but it actually is a pretty attractive end market when you think about the commercial infrastructure required to commercialize these products. If we’re successful, the profitability that comes from that is pretty significant. So, we’re excited about what the next 12 months and beyond has in store.

Chris CooleyStephens Inc. — Analyst

Super. [Speech Overlap]

Chris M. CalcaterraChief Operating Officer

I would just add, Chris, that I’m looking forward to commercializing these new products that are coming next year in 2022. And in 2023, we have — I would consider a pretty good track record for introducing new technologies, new strategies, new approaches and I’m looking forward to that challenge.

Chris CooleyStephens Inc. — Analyst

Super. Well, thank you, gentlemen. On behalf of Stephens and myself, I just can’t say thanks enough. We really appreciate you joining us here for our virtual day. And for everyone else out there, we look forward to hopefully seeing you join us in Nashville come this Wednesday through Friday. Thanks so much, everyone. Be safe.

Chris M. CalcaterraChief Operating Officer

Thanks for having us.

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Thanks, Chris.

Duration: 46 minutes

Call participants:

Joseph E. GilliamChief Financial Officer, Senior Vice President, Corporate Development

Chris M. CalcaterraChief Operating Officer

Chris CooleyStephens Inc. — Analyst

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