Glaukos Corporation (NYSE:GKOS) Q4 2023 Earnings Call Transcript

Glaukos Corporation (NYSE:GKOS) Q4 2023 Earnings Call Transcript February 21, 2024

Glaukos Corporation misses on earnings expectations. Reported EPS is $-0.63 EPS, expectations were $-0.56. Glaukos Corporation isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Welcome to the Glaukos Corporation’s Fourth Quarter and Full Year 2023 Financial Results Conference Call. Copies of the company’s press release and quarterly summary document, both issued after the market closed today, are available at www.glaukos.com. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

Chris Lewis: Thank you and good afternoon. Joining me today are Glaukos’ Chairman and CEO, Tom Burns; President and COO, Joe Gilliam; and CFO, Alex Thurman. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key facts associated with the quarter, the state of the company’s business objectives and strategies, any forward statements or guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call.

As such, for this call, we will make brief prepared remarks and transition into a question-and-answer session. To ensure ample time and opportunity to address everyone’s questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations as well as the expected impact of general macroeconomic conditions including foreign currency fluctuations on our business and operations.

These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today’s press release and our recent SEC filings for more information about these risk factors. You’ll find these documents in the Investors section of our website at www.glaukos.com. Finally, please note that during today’s call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos’ ongoing results of operations, particularly when comparing underlying results from period-to-period.

Please refer to the tables in our earnings press release available in the Investor Relations section of our website for a reconciliation of these measures to the most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos’ Chairman and CEO, Tom Burns.

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Q&A Session

Thomas W. Burns: Okay. Thank you, Chris. Good afternoon, and thank you all for joining us today. Glaukos reported today record fourth quarter consolidated net sales of $82.4 million up 16% on a reported basis and 15% on a constant currency basis versus the year ago quarter. For the full-year 2023, consolidated net sales of nearly $315 million grew 11% on a reported basis and 12% on a constant currency basis versus 2022. We are also reaffirming our full-year 2024 net sales guidance range of $350 million to $360 million. These record results, which further exceeded our preliminary pre-announcement from early January were driven by broad-based double-digit growth across our Glaucoma and Corneal Health franchises globally. Our strong fourth quarter performance caps-off a successful year of execution, both from a commercial and development perspective, leaving us ideally positioned as we enter into what should be a transformative period for our company in the years to come.

From a commercial perspective, strong execution of key strategies within each of our core franchises drove this out performance. Within our U.S. Glaucoma franchise we drove over sales of $38.7 million and growth of 10% year-over-year, driven primarily by the continued commercial rollout of iStent infinite. Market receptivity and adoption of iStent infinite remains strong with surgeon feedback most commonly highlighting the benefits of its three stent solution favorable safety profile and streamlined injector system. Alongside our commercial efforts, we also continue to advance key market access initiatives for iStent infinite with all MAC covering on a case-by-case basis, including two with LCAs in place. We will continue to monitor the various MAC processes and policies as we remain supportive of expanding broad access to interventional glaucoma tools for physicians and for patients.

Moving on, our international glaucoma franchise delivered sales of $21.9 million on strong year-over-year growth of 25% on a reported basis and 23% on a constant currency basis. The strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MIGS forward as a standard of care in each region and every major market in the world. And finally, our Corneal Health franchise delivered record sales of $21.8 million, a 19% year-over-year growth, including Photrexa record sales of $19.2 million on a year-over-year growth of 26%, as our key initiatives continue to take hold in support of this important business. Shifting gears to the development front, as you know, during the fourth quarter, we were delighted to announce FDA approval of iDose TR, our revolutionary micro-invasive, injectable therapy designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

iDose TR is a first of its kind intracameral procedural pharmaceutical designed to deliver glaucoma drug therapy for up to three years. Following approval, our teams have been hard at work executing the initial phases of our detailed coordinated launch plan. In conjunction with these efforts, we’re pleased to announce that just last week, multiple surgeons successfully completed their first commercial cases of iDose TR. We’re happy to report all of these cases went extremely well and early feedback from the small group of surgeons has been very positive. Looking ahead, we plan to continue advancing a methodical controlled launch over the first half of 2024 with a primary focus on surgeon training and establishing market access. As we refine and optimize our training and skill transfer to our sales force and surgical community, we will continue to expand our training and broader launch efforts over the course of 2024.

We are in a powerful position to leverage our established best-in-class glaucoma sales force and commercial organization to drive the iDose launch. Speaking of which, earlier this month, we held our global sales meetings where most of the focus here in the U.S. was on iStent infinite and iDose TR. It was evident throughout the productive meeting that our glaucoma sales force is excited and prepared to execute our plan. Alongside that, we are progressing several market access reimbursement initiatives designed to drive fulsome coverage and payment for the iDose TR procedural pharmaceutical over time. On that front, first, we successfully submitted our permanent J-code application in late December, which should allow for it to become effective in the second half of 2024 based on the CMS cycle for J-codes.

Until then, we are launching iDose TR with a temporary miscellaneous C-code anticipate measured adoption over this initial period until the permanent J-code is in place and we’ve expanded our surgeon training initiatives. Next, we are working to establish payment for the new Category III code 0660T that will cover the procedural component of iDose TR. This includes the establishment of the facility fee through an APC classification from CMS, which we expect to become effective April 1. We will also be working with MAC to secure professional fee coverage and payment over the course of 2024. Finally, our iDose TR commercial launch will be supported by robust set of peer-reviewed literature. During the fourth quarter, the first iDose TR publication was published in the Journal of Drugs and summarizes the Phase 2b three year outcomes.

More recently, another TR manuscript published in ophthalmology and therapy highlighted favorable Phase 3 12-month results. Looking ahead, there are an additional ten articles planned to be published in leading journals, including a manuscript that was just accepted by ophthalmology, which highlights iDose’s TR’s Phase 3 three month results. So to summarize, the response we received from surgeons in the broader ophthalmic community since we announced FDA approval for iDose TR has been overwhelmingly positive and reaffirms our view that with the launch of iDose TR, we are pioneering a brand new category of procedural pharmaceuticals that has the potential to reshape glaucoma management as we know it today. We’re excited to now be in the initial phases of bringing this transformative technology to market and in doing so expanding the treatment alternatives for patients suffering with glaucoma and ocular hypertension.

Beyond iDose, we continue to prudently invest in and successfully advance our robust pipeline of novel promising platform technologies that we believe have the abilities to significantly expand our addressable markets and fundamentally transform our company over time. This includes Epioxa, our next generation corneal cross-linking therapy for which we continue to progress towards trial completion in the second Phase 3 pivotal study and remain on-track for data readout in the second half of this year, supporting our targeted NDA submission by the end of 2024. In terms of our earlier stage pipeline, we commenced three new clinical trials during the fourth quarter of 2023, including one, a PMA clinical trial for iStent infinite in mild-to-moderate glaucoma patients.

Two, a Phase 2a study for iLution Travoprost. And three, a first-in-human clinical development program for GLK-401, our intravitreal multi-kinase inhibitor retinal program in wet AMD patients. In 2024, we’ll continue to drive our robust pipeline forward with additional plans, which include commencing a U.S. IDE trial for the PreserFlo MicroShunt, commencing a Phase 3 study for iDose TREX, our next-generation iDose therapy, and finally completing enrollment in our Phase 2 trials for our iLink third-generation therapy. So, as you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create. At the same time, as we’ve discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based spending and our capital position now and in the future.

In conclusion, I think it’s fitting to remind you of our company mantra, “We’ll Go First”, which for us is more than just a company tagline. Rather, it’s something that defines who we are as an organization and how we lead every day. We are ready to deliver in 2024 and beyond as we execute our commercial launch plans for iDose TR along with iStent infinite. Our foundation is strong and we’re ideally positioned to continue transforming vision for the benefit of patients worldwide. So with that, I’ll open the call to questions. Operator?

Operator: Thank you. [Operator Instructions] We’ll go first to Tom Stephan at Stifel.

Tom Stephan: Great. Hey, guys. Thanks for the questions. Maybe I’ll start with guidance. Joe or Alex, any framework you can provide on how much of iDose is factored into 2024 guidance? And then also what are some of the key inputs supporting that outlook?

Joseph E. Gilliam: Sure. Hey, Tom, it’s Joe. I’ll start off and Alex will add some color he can. Maybe first I’ll start from a macro perspective on the guidance itself. I mean, obviously, we were pleased to see the business continue to deliver and the momentum as we exited 2023, we’re entering 2024. And, I think that the guidance we established overall really implies another year of accelerating growth as we focus on putting in place really the foundational building blocks that we believe will enable the next really decade of growth for our company. I said this, I think, on one of the calls either around the Investor Conference earlier this year or in December when we first gave guidance. There are a variety of scenarios and drivers for our business in 2024 and even within the U.S. Glaucoma franchise of which iDose is really one of those.

And so, I certainly acknowledge and respect the importance of trying to dive a little bit deeper on the specificity around the numbers associated with iDose. I think it’s a little early to get too granular there. Clearly, it’s going to be an increasingly material driver as we make our way through the year and certainly as we enter 2025. And at some point here in the coming quarters, we’ll provide additional disclosure on the actual revenues of iDose as we really transition from, as Tom said, the early access phase into a full launch.

Tom Stephan: Got it. Makes sense. That’s fair. And then just on the iDose label, I know it’s only been a couple of months since approval, but Tom, any updates on the label as it relates to single administration? Have you been able to gather, I guess, any additional color from FDA on their decision? And then maybe more importantly, what the path forward for Glaukos is from here in that regards? Thanks for taking the questions.

Thomas W. Burns: Yes, Tom. I’d be happy to answer it. And so, let me first say that we’re poised for success today given the current label. Even with the current limitation in all our channel checks with our clinicians and surgeons, we see no impediment to the appetite for the use of the iDose product. And so, that’s very encouraging. But to answer your question directly, we’re in the process of repetition to the FDA for re-administration of the iDose device. And, as you’re probably aware within CDER right now, the drug division, there’s a change in the guard. And so, we’re waiting for that transition to happen and the dust to settle, and then we’ll put our petition before that court. And we’re hopeful for a successful conclusion.

In the event that we’re not, remember that we already have iDose TREX, which again contains approximately twice the amount of medication of the iDose that’s planned to enter clinical trial by the end of the year. And so, by our best thinking, we’re targeting a commercial approval for that product in 2028. So, if you think about it, that iDose TREX could become the next re-implantation product for our current iDose products and initiatives. So, I feel like we’re covered in all respects. I feel good about our path forward. We’re hopeful to be successful on repetition in the FDA. We have a sophisticated argument to make to them, but having said that, we’re covered in either of that.

Tom Stephan: Very helpful. Thanks, Tom.

Thomas W. Burns: You’re welcome. Thanks, Tom.

Operator: We’ll go next to Ryan Zimmerman at BTIG.

Ryan Zimmerman: All right. I’m going to try and ask a similar question on iDose in a different way and press my luck here a little bit. But, when you talk about the controlled launch guys, what does that mean? How many surgeons are you trying to get comfortable with an iDose? At what point do you transition to a broader launch regardless of maybe the reimbursement milestones that are up ahead? Just to help us kind of frame how much experience you’re looking for with iDose initially?

Joseph E. Gilliam: Hey, Ryan. It’s Joe. We’ll try not to have you hit a whammy here, but I will give you a little bit of color around kind of where we’re at, where we’re going. Hopefully, it’s consistent with what we talked about during the original approval call. Right now, we’re officially in the early access phase of the launch. And the great news, as Tom mentioned in the prepared remarks, we now have the first procedures having been completed last week as a part of that. That’s a big step organizationally or through our national sales meeting. We’ve begun that early access phase with a handful of docs. And, I think it’s important to note that it is limited in the scope. The goal of that early access phase is really designed to help us refine our training algorithms and establish confidence within our sales force and iron out, any early market access challenges that inevitably come with a product launch like this.

We will transition in the coming months to a broader launch. But like we’ve said in the past, that really goes from, crawling to walking to jogging to running. The objective there is that as we move into those early launch phase that we’ve got all of our reps out, starting with their starter cases, training, one, maybe two doctors at the beginning. And then as they continue to refine their algorithms and their experience, we’ll open that up more broadly as we get into the second half. It clearly, as we’ve said before, starts to hit a stride as you get into the fourth quarter and that’s by design because that also happens to match up with where you expect the market access side of the equation to start to provide a little bit more clean path forward too as you’ve got a fully established J-code, a published ASP and all the things that come alongside that.

So, it really will be a somewhat, I’ll call it linear release, if you will, of our efforts between now and that fourth quarter time frame where we hope to start really running as we then sprint into 2025.

Ryan Zimmerman: Okay. Second question for me, turning to infinite, you guys are going to pursue a label expansion in mild-to-moderate patients. How much of that a gating factor do you think to adoption in current usage of infinite? When you think about how it’s being used today, where it can go and maybe kind of talk about it in the context of both combo cataract and also standalone, as you pursue that label?

Thomas W. Burns: Yes, Ryan. I’m happy to address that. So first of all, let’s talk about the study itself. So, we’re going to do a multi-center prospective study, which will be looking at mean our IOP reduction of greater than 20% from baseline in 12-months with a pre-specified endpoint that we negotiate with the FDA. And so we feel like we’re in a confident position targeting approval at the tail end of this clinical trial given the demonstrable performance we’ve had with the product up-to-date. I think when we look at the marketplace in the LATAM serially, we know that the current marketplace for patients who failed on surgical and medical therapy we’re estimating at about 200,000 patients, right. And so, when we expand and we look at going to mild-to-moderate patients, we believe by our estimations that we’ll be looking at additional 400,000 to 500,000 patients that we would be covering by doing so.

So that, in and of itself gives an expression of how we intend to expand the market. I think the product will be used equally. I think as we get these get the approvals, I think there’ll be a strong initiative as we move forward with interventional glaucoma where people will start to feel strong confidence in using this in standalone cases. And certainly, our upgrade to 5493 on the APC side doesn’t hurt us as a financial incentive for surgeons to be doing the right therapy for their patients. I think as well on the combo cataract side, it makes sense, whereas particularly when we have a broad label that surgeons will feel very comfortable down to the very early innings of glaucoma and using this product in combination with cataract surgery.

Why wouldn’t you? You have three stents versus two stents in this case, and we showed demonstrable additive effect with those different products. So, I feel like that’s the way this will come on. And one of the things that I feel very strongly about is that over time, surgeons will begin to use iStent infinite in conjunction with iDose. And so, why do I say that? Because iStent infinite is showing a strong ability to re-establish physiologic outflow through the trabecular meshwork. iDose works on a different part of the eye, the uveoscleral system. And so, using these products in combination should provide a very robust combinatorial care and procedure therapy for surgeons as they move forward. And we think that within the Medicare fee for service system, there’s going to be no impediments.

There’s two separate CPT codes, different mechanisms of action and these are different product classes. And when you think about it, 50% of patients right now that use topical meds are on two or more medications. So, combination therapy rules half of the current identified diagnosed glaucoma patients. And so, we think that this will be an extraordinary opportunity in combination therapy. As we get into commercial payers and Medicare advantage, there’ll be some restrictions just like there is with standalone treatments with infinite and with iDose. But we’re highly encouraged. I love the double whammy of having both these harbingers and catalysts giving us the fulcrum to create the interventional glaucoma market space.

Ryan Zimmerman: Thanks, Tom. Thank you for taking the question.