So that process will be ongoing over the course of many years as you try to optimize the coverage within that channel to benefit those commercial patients who will rely upon it. But we’re ready to go. It’s much more about us really unlocking or releasing the commercial side of our iDose business before we start meaningfully making a change in the Specialty Pharmacy side.
Operator: Your next question will come from the line of Sam Brodovsky with Truist Securities.
Sam Brodovsky: Just two quick ones on iDose and then I’ll try and sneak in an international one as well. First, just any update or any color you can provide on incremental data on when we may get a replacement label or how those conversations with the FDA are evolving?
Tom Burns: Thanks for allowing me to engage after all the questions on iDose commercial. Yes, as we talked about, we have, I believe, prepared a really compelling proposal to submit to the FDA. We waited as you know there’s been a change in the guard at the FDA and so that dust is still settling. So we will be proposing the movement towards re-administration and really in the coming days. We’re hopeful to be able to get a positive response, but we’re not counting on it. And I will tell you, as I’ve said before, one of the things that investors and analysts should be reassured by is that we have TREX, which we’re on track for beginning that clinical trial by the end of the year. And when you do any kind of chronology of when our expectation is to have that commercially available, as we talked about before best case would be at the end of ’27 to ’28.
And so any patient that is undergoing an iStent implantation typically or invariably by the end of this year or early into 2025, we believe that the TREX will become a compelling offering for re-administration for those patients.
Sam Brodovsky: And then also, is there going to be any constraints as you roll out to more doctors? Any constraints we should be considering in terms of how much they can adopt over the coming months before the J-code, whether that be supply or otherwise?
Tom Burns: Well, I think that it’s at least in the I think the way you asked that question in the context of the Q2 ahead of the J-code, I think it’s honestly more of the same as we experienced in the second half of February. You’ll see of the second half of the first quarter. You’re going to see some who are more confident and will continue to adopt based upon the clinical flow of their practice and obviously folks on Medicare patient population. And you’ll see others who will start and do some trying and ultimately for payment to adopt. I don’t expect there to be a meaningful inflection in the context of the second quarter as it relates to iDose other than the fact that we’ll continue to solely expand access to those surgeons.
Operator: Your next question will come from the line of Anthony Petrone with Mizuho.
Anthony Petrone: So I saw on your summary, you have had some initial educational meetings with the MAX as part of your efforts to secure professional fee coverage. Can you give us any updates from these talks? Do you have better insight on the timing of when this professional fee coverage will come through? And could they come all at once from the MAX or be a bit staggered? I’ll have a quick follow-up.
Tom Burns: I think this is ordinary course activity as we do anytime we launch new products. There’s an education process just to make sure those MAX who are open to being educated on a new product like iDose, they understand what it is and the procedure associated with the drug. And so we’ve been executing on those as an ordinary course. If you look back at the history of Glaukos as we’ve launched products, professional fees tend to take somewhere between six to nine months on average to start being at least more consistent in what they’re being paid and ultimately then be put on fee schedules. And they rarely happen all at once. They tend to happen on whatever schedule and timeline the MAX themselves individually are on versus it being one fell swoop across multiple MAX at a single point in.
Anthony Petrone: And quickly on gross margin, I know you came in a bit lower than expectations, and I know that’s kind of due to the launch. Do you just see that do you see it stepping down next quarter or we see step up next quarter and kind of through the rest of the year?
Alex Thurman: I would say TBD, right, we would just take — I’m kind of guiding that you keep in mind a range, maybe between 80 to 84 over the course of the year because of the volatility or potential volatilities rollout iDose. And so but we again all affirm that we are confident in the accretive nature of iDose, the gross margin over time and we should start to see that more full suddenly as we exit this year and enter next year.
Operator: Your next question will come from the line of Steve Lichtman with Oppenheimer & Company.
Steve Lichtman: I wanted to ask about the core U.S. glaucoma business and market. One of the things you had highlighted in your summaries is potential volatility from all of the MAC movement late at the latter part of 2023. Are you still seeing some aftershocks from that one way or the other? And also if you could talk about what your expectations are looking forward? Are you hearing anything with regard what might be next, excuse me, on the MAC front?
Tom Burns: Yes. I think it’s been relatively quiet in the context of the impact. There’s probably a modest benefit to the stent side of our business as some surgeons or practices have reevaluated the tools that are being deployed based upon the objective data that’s behind those tools. But I think it’s a much smaller negligible impact to the quarter versus as we’ve spent a lot of time here talking about the growing standalone utilization for example. As we go forward, it’s status quo for now. The MAC next steps and the timing remain unclear. But as we’ve said before, we do expect to hear from them again. And that stance is really unchanged. And so, as always, it’s been the case historically, we’ll continue to support the right of the physicians to make clinical decisions on behalf of their patients, if and when we see something from these MACs.
Steve Lichtman: And Joe just quickly on OpEx, should we still target about 10% growth year-over-year this year?
Alex Thurman: I’ll take that one. The answer is, yes. I think the easiest way to think about it is from over the next three quarters, you should think of some kind of reasonable sequential increases over time that you land at the year at about a 10% growth in OpEx compared to the base in 2023, which was 360 excluding IP R&D.
Operator: Our final question will come from the line of Michael Sarcone with Jefferies.
Michael Sarcone: Just another follow-up on iDose, going back through the first few years of the initial iStent launch, I know you talked about you had a year or two where you did 700 new reps train. You also often talked about, I guess, in 2015, the average rep training three surgeons per quarter. If you think about it kind of along those metrics, do you expect that the average rep today could train more surgeons than that, given that a lot of these surgeons are already trained in open angle procedures or would it be something less than that because maybe they have more products in the back to sell. Just wanted to get your thoughts on how you’re thinking about that metric?
Tom Burns: Well, I think you largely framed it the right way. And so that’s why I’m a little bit hesitant to get too specific on the pace of that training. I’ll call it the tailwind from a comparable standpoint is that as you alluded to, we’re not training the majority of these surgeons on angle based surgery. So from that standpoint, some of the harder elements of that training, we don’t have to spend as much time on. The offset to that is exactly what you said and that we’re not just simply launching a single product here in the case of iDose. We have a portfolio, there’s a lot of activity around iStent infinite. And so I think we’ll have to feel our way through as the reps start hitting their full stride in terms of iDose trainings and onboarding as we kind of exit this year and go into next year. And we’ll provide a little bit more, I think, context to that as we refine our own expectations.
Michael Sarcone: And just one quick one. You talked about you’re commencing early initiatives to secure commercial coverage for iDose. Do you give us a download on any types of conversations you’re having in these early days with commercial payers and what the feedback and or receptivity is?
Tom Burns: Yes. Those efforts are really just beginning, but there are a lot of conversations going on. In fact, there’s actually a fair number of policies that have already been issued out there, even though we’re not commercially trying to drive that side. Coverage has started to turn on in a variety of the commercial payer and other settings around that. I think to date, what you’ve seen from those policies is exactly what we’d expect and quite frankly not all that dissimilar than if you look at the coverage policies that are out there for [Derista], today of which there are plenty. So, in terms of the interventional procedural pharmaceutical approaches, I think the payer committee thus far has been following the playbook that they established with [Derista] as they think about that coverage for iDose TR.
Operator: I will now turn the call back over to the company for any closing remarks.
Tom Burns: I want to thank all of you for your time and attention today and continue to thank you for your continued interest and support of Glaukos. And with that, goodbye.
Operator: That will conclude today’s call. Thank you all for joining. You may now disconnect.
