Glaukos Corporation (GKOS) Earnings Call Transcript & Summary

So let's get started. It's closing out this Tuesday. I'm really happy to be introducing members of the management team of Glaukos. We have CEO, Tom Burns; COO, Joe Gilliam; and Alex Thurman, CFO. So we'll start with some prepared remarks, and then I will join them for a Q&A.

Okay. Thank you. Good evening and thank you for coming here tonight to learn more about Glaukos. Our founding mission at Glaukos has been to devise a facile implantable injectable procedure that could liberate glaucoma patients from a lifelong consignment to glaucoma for topical drop therapy. And in doing so, we have -- really had been, from the very beginning, it's been -- our birthright has been interventional glaucoma. From the beginning, we sought to transform glaucoma therapy by devising a portfolio of products that would treat patients across the full range of glaucoma disease stage severity. Our 2 major products within the first 5 years were iStent and iStent inject. And those products were both the harbinger and the catalysts that help drive the entire global MIGS marketplace that we know today. But our ambitions were unabated. In 2008, we started to look, can we take this form factor and could we devise a drug delivery system that would hold a complement of an anti-glaucoma medication that could treat patients for several months with a single injection. Our first challenge was coming up with the appropriate prostaglandin analog to be able to place resident within the vessel. We chose travoprost, a highly potent prostaglandin analog, and a prostaglandin analog that rapidly hydrolyzed from an ester into a free acid within the eye. The problem was travoprost was only available in a [ lifeless ] form. So we had to figure out how to look at and create an intermediate form in a travoprost oil, which took several months and some heavy sledding. From there, we had to figure out how do we take and preserve this product in situ because I worried that the parent compound would decay in situ into inactive ketone analogs. And so we had to then figure out how to take an antioxygen and make it stable. And finally, we had to figure out how to take a membrane made of ethyl vinyl acetate, determine thickness and percentage to be able to precisely be able to calibrate what the dilution rate should be to be able to achieve minimum inhibitory concentrations within the eye. From there, it got even harder. Then we had to figure out who's going to make this product. And in our first clinical trials, you've seen the size of these devices. We actually had to hand fill them and hand cap them in a sterile setting to be able to show proof of concept. And over several years, we looked at several contract manufacturers to try to make this product for us. We got no bids from everybody. Nobody wanted to take on the pain and hassle and the complication of transferring this technology. So we had to internalize it and bring it ourselves, and we did so by creating, as you see here, 134,000 nano manufacturing facility, which is state-of-the-art in San Clemente. And importantly, for a company that was a device company that was then transitioning into a pharmaceutical company, we came away from the preapproval inspection with 0 483s, an unblemished track record. So we continue to produce those today. We've produced our clinical lots there. Those clinical lots went into 2 pivotal trials. We had to do 1,150 patients in order to get this product approved. We did that with the hangover of COVID. So we had to recruit these patients and then monitor them closely to make sure that they didn't come in outside their windows because the FDA was going to be unforgiving, if that happened. And then finally, following the Genus ruling, which then obligated companies to be able to approach both the drug and the device division for a combination product, we had to do both and have the equivalent of an NDA and a PMA and over 100,000 patients -- or sorry, pages that we submitted to the FDA to get final approval. So I thought you would want to hear that journey. It's been herculean. It's put years on my life. I wanted to share that. So you shared the burden with you tonight. And we made it. So in December, we were very pleased to be able to get a final approval of the iDose TR. It is the first intracameral drug delivery device that has a sustained capability of treating patients out to 3 years. As we look at device, it closely follows the form factor that we achieved with iStent and iStent inject, which we believe are the smallest devices that have ever been FDA approved and injected into the human body. It's incredibly small and yet houses this complement of prostaglandin analog of travoprost, which is 25,000 times more concentrated and potent than the travoprost eye drop. That's why we're able to get the extended duration we see. Complicated mechanism of membrane delivery to achieve a Fickian 0 order distribution over time, a very facile application system. And most importantly, we took a risk early on. The conventional wisdom would say, come up with a biorotable that elutes and then goes away. That's what the market wants. And we were, in retrospect, prescient to be able to think about what would happen with a biorotable in the narrow angle that bounced around and could cause endothelial cell loss. So we ended up creating a product that could be anchored and has no migration within the anterior chamber. It meets an impressive market need. It's clearly our position and many others that the current standard of care is broken. Surgeons reflectively put patients on medical therapy and drops when they are diagnosed with glaucoma. But it's our contention that while topical drops work in clinical trials, they don't work very well when patients don't take them. And we know from retrospective and prospective studies that the rate and ubiquitous rate of noncompliance is extraordinary. 90% in a recent study of patients are not inherent to their topical medications that makes sense. This is an asymptomatic disease. And these drops just cause a malady of side effects. Patients don't take them. In fact, 50% of patients don't even refill their scripts after 6 months. So what that leads is a sanguine response from surgeons who continue to write scripts, but patients, the underlying progression continues. These patients get work -- get worse. And in a recent study in Minnesota they followed patients over 20 years that were diagnosed, treated for glaucoma, and 14% of those patients became blind at one eye. These are patients under active observation and being treated. There has to be a better way. One of the fortuitous outcomes of us choosing travoprost is that we were able to submit our regulatory pathway under a 505(b)(2) designation. And we prospectively powered the design of our study to achieve noninferiority to topical timolols what the FDA obligated us to, and we did so handily in 3 months. Importantly though, when we look at patients that were on prostaglandins prior to treatment, 125 patients were selected that were on a single prostaglandin. They were washed out. You see their pressures go up to near 24 millimeters. They were then placed on iDose. After being placed on iDose, we then looked at their pressures, and they did far better, significantly better with iDose in the intracameral approach rather than with topical medications. Pretty extraordinary finding. And then when we looked further, of our 1,150 patients that we enrolled in our 2 pivotal trials, the most important observation was that 81% of these patients were on 0 medications, well controlled and on 0 medications at a year. Even though 23% presented with 2 or more medications pretreatment, that was an unexpected and surprising and delightful finding. Interestingly as well, 93% of these patients were well controlled on the same or fewer meds at 1 year. That tracks nicely with the Phase IIb data that you've already seen where nearly 70% of patients at 3 years were well controlled on the same or fewer meds. And you can see that that far outpaced timolol eye drops in the 3-year observation. I think an important component as well is justifying the sustainability and durability of this product. We actually looked at patients, 210 patients that we tracked over 2 years. And every 3 months, we expanded an iDose, and we took and we looked at how much of the juice remained in the implant. And we also took aqueous taps to look at the travoprost free acid concentration over a 2-year period. And you can see here, throughout 2 years, we had far -- we had extraordinary travoprost free acid concentrations, which were well above the minimum inhibitory concentrations necessary, and we still had juice in the tank at the end of 2 years, which then doesn't surprise me when we see the data that we're seeing all the way after 3 years with a control with a single injection. This is a great validation of the work that we saw from the Phase IIb study. I think one of the most important and underappreciated aspects of iDose is its safety. So -- because we avoid the iron curtain, we don't have to go through the cornea to be able to achieve substantial values within the -- inside of the eye. We can have a very micro-elution rate inside the eye to be able to achieve an effective outcome. And because of that, you can see here we saw no adverse events of periorbital fat atrophy, very low conjunctival hyperemia, 3% versus what we see with topical prostaglandins, which is on the order of 30% to 50%. No adverse events of corneal endothelial cell loss. And then finally, a very low incidence. I think the incidence was a couple of patients that had iris color change, which is an adverse event associated with prostaglandins. Overall, an extremely powerful and safe product with mild to moderate low incidence of the intraocular pressure spikes, iritis, dry eye, et cetera, that all resolved at very, very early time points. So this completes -- this iDose product completes what I've been talking about for years, which is to have -- Glaukos have a portfolio of products that serve the full range of disease stage severity, which give us a compelling approach into the marketplace at scale and the ability to attract the attention and the devotion of surgeons. You know that the iDose TR has a label indication that's wide open. It allows us to implant patients all the way from ocular hypertension where they see no perioptic damage, all the way through refractory eye disease. We think that this product will form a catalyst for us to create this whole new mindset of interventional glaucoma where surgeons start to intervene far earlier in the treatment cycle of treating glaucoma rather than reflexively adding med after med until they fail, until they go to surgery. It's going to happen. We built the MIGS marketplace worldwide. We're going to build what we call the IG or the interventional glaucoma marketplace. We're doing so serially. First, we introduced the iStent in combination with cataract surgery, looking at a TAM of about 500,000 patients, comorbid glaucoma and cataract surgery patients. We added the iStent infinite, which as you know, is used in patients who failed on medical and surgical therapy, looking at 200,000 annual patients and iDose is the big kahuna. It allows us to treat wide scale and to go after patients across the full spectrum of disease stage severity. And we're going to do so the way we've always done so. I think predictably, responsibly and with success, we'll have a controlled clinical launch. We'll look to do superb training. We're going to focus in on glaucoma specialists first, which are the high priest within ophthalmology. They control some of the mindset and the adoption rates, and so we'll focus there first. And then we'll spend the first 6 months or so heavy on market access. So we'll look to be able to cross walk the procedural code over to a Category I design procedure so that we can get the highest benefit and payment for surgeons on the professional fee side. We will be assigned an APC in the second quarter. And then we'll look and we've already filed for a J-code, and we'll expect to have a formal J-code by the second half of the year. And then it's open field running. And we'll be expanding rapidly into the core of ophthalmology and into comprehensive ophthalmologists, where the appetite is very, very strong to use this product. We're going to put this in the hands of, obviously, a skilled sales force. And so this becomes something where we've already achieved scale. We've got now 200-plus boots on the ground, 70 quota-carrying reps out in the field. And rather than giving kind of a blanket approach, we are going to be a far more sophisticated marketer and be able to segment the market to areas where this has the greatest resolution and adoption rate with surgeons. And that goes all the way from patients who are noncompliant who have been shown intolerance to topical drops that have underlying comorbidities like dry eye and patients with Parkinson's and other diseases that have difficulty putting the drug in their eye. These are the areas that will receive a prominent reception and where the product will be used extensively. And then finally, the patient has to be at the core and patient access. And so make no mistake, we're aware of this. And so we have already established a full infrastructure of billing and coding support. We've got reimbursement liaisons, which are at the ready to help our clients, our customers be able to adjudicate any claims adjudication that they need to with commercial payers and with MAX. We've got a glaucoma patient services approach, which walks patients through the patient journey, so people actually will call up and say, Allen, we understand you have glaucoma, you've been diagnosed. Let me talk to you about the iDose procedure and what it can mean. These are important components. They're done successfully in rare disease. We're going to be implementing this here because there's so much ground that we'll be able to gain. We'll have co-pay assistance programs for commercial payers. So make no mistake, we'll be able to mitigate any co-pay issues with consumers. And we'll have specialty pharma available for those surgeons who don't choose to buy and bill and would rather go through and have someone else take care of business and seek adjudication of claims. And then finally, important to me and to the senior team, we're establishing an iDose Your Dose program. I don't know if many of you are familiar, but there's a company out there that has [ Tom's ] shoes where they make shoes available when they sell a pair, they make a pair of shoes available to send them to indigen people in developing countries. We're going to set aside an iDose. For every iDose we sell, we will set one aside for those patients who have financial hardship here in the states or overseas and make it available for them. So iDose is a huge game changer for us. It's a lead in the platform. Again, I've talked about these 5 platforms, which we think will be the font and throw off cascades of generational devices. This small company has invested almost $0.5 billion in these organic programs since the beginning and look at the payoff. When some of you were with me back when we launched the IPO in 2015, we had 4 programs that we were walking through the paces of regulatory approval. Today, we're looking at 14 programs that are well in development or actually going through a regulatory process as we speak. So we have made, I think, prominently good use of our capital and moving forward, what I think is one of the broadest and extensive pipelines in ophthalmology. So let's talk about that pipeline and what we've achieved. Just in the course of this year, it's an important redundancy to talk about the iDose TR approval after 15 years of hard effort and herculean approaches. iStent infinite, we began in a program this year to broaden the label from its current label of failing on medical and surgical therapy to patients who have mild to moderate glaucoma. I'm convinced that if we're talking about this in some period of time in the planning period, we're going to be talking about patient or surgeons that are using the iDose in combination with iStent infinite to achieve the lowest pressure as possible in glaucoma patients. It makes sense. You've got iStent infinite, which is a trabecular bypass, which restores physiologic outflow. You have iDose, which works on the side door, the uveoscleral pathway. In conjunction, this should be additive and bring patients down to the lowest pressure as possible. We began an approach with iLution Travoprost, which is this transdermal cream, which we put on the surface of the eye to be able to achieve intracameral values to be able to treat glaucoma. This is -- could be a paradigm-changing technology if it works. We think that it will. It's already shown promise in dry eye and presbyopia, but we've already started a clinical trial in the use of glaucoma. And we think that this will add in compliance and certainly take away all the issues or many of the issues of preservative toxicity that plagues topical eye drops. In cornea, we went through and recruited our Epioxa trial in record time, less than 6 months. We do the full trial. And as we've talked about iLution, we continue to look at the dry eye and presbyopia data, we're impressed. We're making decisions on how we move forward there. And then finally, in the area of retina, I've been talking about this for some time, we've been looking at these implants in a rabbit vessel leakage model for over 2 years. We are just in a position now where we open up the clinical trial to look at an axitinib TKI in the treatment of AMD. And that clinical trial has just commenced in the fourth quarter of this year as promised. For 2024, let's look at some of the key milestones. iDose TREX, this is our second generation, which we think will hold twice the amount of medication that the first iDose has. If you think about this, if we're successful getting this product approved in 2028 or earliest late 2027, this becomes the reimplantation product for the people that are getting iDose today. So we're already on board. We contemplated this. We've been working hard to make this available, and we expect to begin that clinical trial before the end of the year. IStent infinite will be in -- deep in the clinical trial enrollment and PRESERFLO is a device that we continue to negotiate with the FDA and hope to be able to enter that clinical trial in the first half of this year, certainly in 2024. And then finally, we have a second-generation product, which is a laser-guided approach to the treatment of keratoconus, which we think will be an important second-generation product in the keratoconus marketing. And make no mistake people ask me, who my favorite child is. Clearly, iDose has just been born, and so I'm spending a lot of time with him. But as we look forward, Epioxa will be an accelerant. So stay tuned. We expect to be able to file that NDA by the end of the year and have that product available by the tail end of 2025 in the U.S. market. So you see the comp on what we've accomplished. How many companies come from a standing start to where we are today across glaucoma, cornea and retina. I think there probably are very few. We're proud of what we have and what we've accomplished and where we're going and not only that the progress because none of these have fallen out to date, right? We continue to move forward with hopes, not all will end up working, but we are actually very, very delightfully proud of where we are at this stage. And on the operational side, let's think about where we've come from. From 2015 where we had 2 markets where we participated in today, we have 17 vertically integrated international marketplaces with 275 employees and some really prominent and great work being done outside the state so much so that if you look at our current revenues, now over half come from outside the United States or from cornea. And that's what we saw is to diversify our portfolio to be able to give us -- and mitigate any potential risk. We've grown the business precipitously. A 20% CAGR growth over the last 8 years. And think of these margins we've held now at 83% since we started talking now well before 2015. And that's led to what I think is a nice balance sheet, which we continue to hold at over $300 million. So we think our future is happening as we speak. The iDose approval was a 15-year odyssey, which ended in tremendous success. Interventional glaucoma, you're going to hear more and more about this in the future. This, again, is a change of mindset. It will not happen overnight. It will take years. But we built the MIGS marketplace. We will build this marketplace as well, and that's just going to mean an accelerant and an opportunity for us to continue to gain ground in this unmet market need in glaucoma. International continues to perform well in several marketplaces, as you see, and we've already talked about the significant progress we've made across the board in our pipeline. So what's next? So in 2024, we're well positioned. Obviously, our crystalline focus is going to be on taking iStent infinite and bringing that forward and creating a position where that becomes with reimbursement adaptation behind it, a prominent product in the treatment of glaucoma. And then the iDose TR, we will be focused on from day 1, we are focused on, and we expect that to be a highly successful launch and probably one of the top launches within ophthalmology in the last decade. We talked about interventional glaucoma and we also talked about Epioxa. Again, stay tuned on Epioxa. I do believe that will be the next accelerant, the next [indiscernible] event in addition to iDose, which will move this company forward while we continue to bake a number of these items within the pipeline. So we use this mantra we'll go first, and it's important because to me, it's less a statement of aspiration, it's a statement of fact. We led the entire and built the entire MIGS marketplace. We're building an entire marketplace based on intracameral drug delivery systems. We're building from a standing start of marketplace using cross-linking treatment. We're taking a risk and moving into transdermal treatment of ophthalmic anterior segment disease, which I think will pay off handsomely. And we're among the first companies to look at small molecules for the treatment of AMD, DME and RVO. So we do go first in all aspects. And because of that, I do believe that this company will become the next powerful strategic player within ophthalmology. So with that, I thank you, and we'll open up to questions.

Okay. Thank you for that. Before we kind of dive into iDose, which I'm sure most people here want to talk about, I do want to kind of cover over the results that you preannounced this morning and your reiterated guide. So relative to where Street expectations were at, you came in roughly $5 million above. So a really strong exit to the year. You were worried that there might be a little bit of noise around the LCDs. So I guess relative to your expectations, what ended up coming in a bit better than expected? And should we think about that momentum continuing into 2024?

Sure. I mean I think we outperformed really across the board really in each of the 3 franchises, and we'll get more granular on that when we obviously release the results in February. But you sort of led into the conversation on some of the things that we were concerned about. And I think really for each of those concerns that we expressed as a part of the call and then again with the iDose approval call, most of those, we were successful in holding off. And so from an LCD perspective, I think the combination originally been pushing that out a little bit in terms of the deadline combined within ultimately them pulling it. We saw less of the disruption in the channel from at least our perspective as a company. Others may have seen it a little bit differently. But from our standpoint, it was pretty much a normal finish to the quarter where we were concerned about some of that -- the bumpiness there. And we were also a bit concerned as we were making the transition with some of our operating teams around the spillover effect it might have on the cornea side. And we were pretty successful at navigating that throughout the quarter. And as a result, we're pleased with the results there as well.

So you touched upon the LCD situation. And it's been kind of an ongoing saga. They finally just decided, hey, we're just rolling back to the previous LCDs that we had. Is that something that, one, you see them revisiting in the near term? And do you think that kind of desire like clearly, there was some desire to maybe crack down on some of the other technologies canaloplasty going [indiscernible] combination use. So is that something that could come up again, maybe with a bit more of a nuanced take?

I think at this point, anything is possible in the context of the way you're asking that question. I don't think we know what the next step for the MAX are in that. Thankfully, we're in a position where, as we said, even when the original proposal was put out there, it's sort of a net neutral for us, right? We have the full portfolio. Our focus throughout this whole thing has been about getting it to a better place in the context of our customers and then being able to make the clinical decision-making with the products. And so from that standpoint, then pulling it back is not a bad thing in terms of the long-term health of our industry that we care so much and we're delivering these products into. And I think we'll continue to play that role in trying to lead both with the societies as well as where possible with the MAX. But the next steps, we'll have to see. What we do know is we still have a valid LCD reconsideration request that we ask, which is very specific to iStent infinite, and we look forward to them resolving that in the months and quarters ahead.

Got it. So moving on to iDose. When you announced the approval, I think apart from the fact that you got the approval on time, which was great, I think one of the real exciting things that was announced that day was the price, right? The WAC of $13,950 I think, was significantly higher than what investors and the Street were really expecting. So that's good, but it's also led to some questions, some concerns from people who maybe aren't as familiar with that reimbursement process. So just to kind of clear the air, is there any point during the J-code process when you're trying to establish reimbursement for this, where there could be pushback against that number? I know you framed it in terms of an annual benefit and from that perspective, it looks reasonable. But just to kind of clear the air on that question.

Yes, I was going to say. So we don't think so. So as you look at how we frame this and how we approach the treatment as I said from the beginning, one of the things -- the enviable things that we had was our Phase IIb data that we had in hand to show the length and duration. And the other favorable thing is the precedent. So if you look at some of the procedural pharmaceuticals that we are now compared against, we are in the mid to lower range to some of those higher paying procedure pharmaceuticals. So I don't anticipate any issues with the J-code process. Clearly, when we get out in the field, we'll see our typical issues and challenges with commercial payers and others that will take a similar position as they've taken with [ Arista ], which typically may edit and limit the use of iDose to patients who failed on a medication or 2. But other than that, we think this has been fairly priced given the game-changing mechanism, given the comparable procedural pharmaceuticals against which we weighed, given the internal pharmacoeconomic analysis that we've done pretty extensively over the last couple of years. So I'm confident we're going to be in good shape.

That's exactly the answer. I would just add that we have a respect for why investors were where they were at in the context [ I expect ]. We never leaned into that part of the conversation. So we understand why that might have been where the Street was at coming into it. But candidly, from our standpoint, as a management team, as we evaluated all the scenarios, and we worked with our external advisers and the various things, those pricing scenarios were not really significantly considered on the table. I mean they were a part of all the scenarios. But I will tell you, there were folks around the table from an advisory standpoint who thought we could, quite frankly, go higher. And ultimately, we landed in a spot that Tom, myself and others felt comfortable with.

Got it. And when we think about your current -- your current patient base is largely Medicare, I want to say around 80%. So when we think about coinsurance for that for iDose at this potential price, is that something you seem to be working on some patient assistant programs and payment programs? Is that something that you're kind of ready to address as well?

It's certainly a significant factor as we thought about all the scenarios around price and access to the patients who will rely on iDose. You have to break them into their individual constituent buckets, the largest of which is obviously traditional Medicare or Medicare fee-for-service and nearly all, I mean, not all will come with a Medigap supplemental coverage where the out-of-pocket dynamics are more limited for those patients. Especially patients who are dealing with a lifelong progressive disease like glaucoma, it's very common for them to carry a supplemental insurance, whether it's Medigap or secondary commercial or even Medicaid dual eligible citizens or patients. So you have that group. On the commercial side, you referenced it, as we get coverage there, you solve that through co-pay assistance programs. And then on the Medicare Advantage side, for those patients who have higher deductible components, you tend to see them come to the procedures of this magnitude later in the year as their deductibles have already been met in a significant way throughout the year with other procedures and things that are going on [ in the way ].

When I think about the guidance that you put out, that $350 million to $360 million that you put out initially with the iDose approval and that you reiterated today, I understand that this is probably something you're not going to be able to explicitly talk about. But how should we think about the contribution of directionally, if we take your base business today, how you perform in 2023, we grow that by some percentage, iDose is on top of that? How are you thinking about the growth of the base business and then we can kind of back into what iDose is on top of that, [ I suppose ]?

Well, I'm not sure I would get that granular. So you're -- it's not surprising. And as we -- we'll get to a little bit more of that granularity on the February call. But I would say that when we set that number, and obviously, it's very early for us to do it, but we felt like it was important to establish a baseline for investors given such a pivotal announcement for the company going into next year and a lot of the uncertainty of what it would mean to our top line, we were factoring in sort of as many as 5 different scenarios. You have everything that you've got going on already with your cornea franchise, everything you've got going on already with your international franchise, when products are coming and reimbursement shifts, all the normal stuff that are going on there. And then I know a lot of the attention has been focused attention on the U.S. side where there were 3 major things that we're factoring in. What does the LCD dynamic mean driving interventional glaucoma through iStent infinite as we now start to turn on the right coverage and recurring payments of the various MAX, which we are seeing towards the latter part of the year and then, of course, the most material, which was iDose. And so I think rather than get into the specifics of the legacy or however you want to reference it, we've taken into all of those scenarios into consideration. And there's a wide band within each one of them that we've tried to factor in to land on what we felt comfortable with the $350 million to $360 million.