All right, good afternoon, everyone. Tom Stefan with Stifel. Very excited to have Sight Sciences here with us today. Pleased to be joined by Paul Badawi, CEO, and Ali Bauerlein, CFO. I'll dive right into things if that's okay, and I'll start with surgical glaucoma, some near-term related questions. To begin with the first quarter, Ali, you initially guided to 1Q surgical glaucoma down roughly 10%-15% year-over-year. You beat that nicely, down only, I think, 6% year-over-year. Ali or Paul, maybe if you can start by talking about observations in the quarter specific to surgical glaucoma and Omni, and maybe dynamics that trended a bit better than your expectations in the first quarter?
Yeah, I can take that, Tom, to start. You know, obviously we're in a pretty dynamic MIGS environment with the new MIGS restrictions in place that limit the combination of multiple MIGS at the same time as cataract surgery. When we put guidance in place, we assume the industry and Sight Sciences would experience that overall decline in MIGS devices used, even while you still have the similar or same number of overall MIGS visits happening. There's just less claims occurring. That was, you know, kind of consistent with our expectations. We've now seen the Q1 claims data and, you know, consistent themes there. We did, obviously, you know, when we set guidance, we wanted to be prudent with it, given the fact that it was still early in that transition and we didn't know exactly how many of those multiple MIGS we would win.
We do think that both Omni and Scion are performing very well in this new environment, and both are performing slightly above the levels that we had expected. You know, Omni with its strong clinical efficacy, surgeon preference, long-term customer relationships, and then, of course, now with the launch of Omni Edge, I think all of those are really helping it, you know, take a slightly more than its fair share in this conversion down to one MIGS world.
Got it. That's really helpful. You said you've seen maybe some claims data and that Omni may be taking a bit more of its fair share. Maybe if you can just elaborate a bit further on, you know, kind of the trends you're seeing or the tendencies that you're observing from a share standpoint, talk about just kind of surgeon behavior and maybe if there's any data around the claims that you can back that with, that would be very helpful?
I would just start off clinically, Tom, and procedurally with Omni and what we're seeing in the market. Omni was designed to be multimodal in nature, offering the surgeon more functionality with a single device, a more comprehensive procedure indicated for canaloplasty followed by trabeculotomy. Omni by itself stands alone in that regard that it can, it can address all three points of resistance in the conventional outflow pathway. In a one MIGS world, while, you know, the transition is underway and devices used, the market is contracting for a period of time from a relative competitive positioning, Omni is strong. Some surgeons were using part of Omni's functionality and combining it with, for example, a stent, to address the diseased trabecular meshwork. Now we can go to those surgeons and say, in a one MIGS world, you can use more of Omni's functionality.
You can use the canaloplasty in addition to the trabeculotomy and address all three points of resistance as you were doing with these combination MIGS in the past. We have felt good about our competitive position entering the year, recognizing that all of us in MIGS would have a headwind until these restrictions are lapped in the fourth quarter of this year. We are going to continue to execute with excellence commercially. As Ali mentioned, we have long-term relationships with our customers and proven technology. You know, Omni is a very mature product and we are continuing to innovate on it. As you mentioned, we have released Omni Edge, which I think is getting very good reception from the market, and we continue to innovate on the Omni platform and we will be releasing additional innovations on that platform in due course.
Got it. And it seems like from a share standpoint, Omni and Scion doing well, Omni primarily canaloplasty, Scion, goniotomy. So, is it stents who may be kind of losing more than their fair share, from a market share standpoint, or talk to what you're seeing, across the different types of MIGS procedures within the claims data year to date in this new kind of MIGS environment?
Yeah, I think that's right, Tom, that maybe stents are losing a little bit and goniotomy is losing a little bit as well. I think that those are trends that we'll have to watch over more than just a quarter or two because, you know, these will take some time to fully play out. We do think that we're well positioned in this environment. Omni also can bill under goniotomy, so it's not, Omni doesn't have a unique code. And so because of that, we can't say specifically how Omni is trending in terms of share gains or losses more than, you know, kind of how we see the competitive players play. We do see that when we look at visits that include these multiple MIGS, as we said prior to these LCDs going into effect, it peaked at about 15% of the volume.
That's now in Q1 down to about 5% of the volume. Now, obviously that's still allowed in a couple max and then commercial plans as well. That big shift from 15% to 5% has occurred in that first quarter, and you see the mass majority of the volume coming out as expected.
Great. That's a great segue into my next question, which was, you know, as we think about these LCDs more broadly in the context of MIGS volume, to your point, Ali, upon implementation, they were somewhat disruptive in 4Q 2024. Again, in 1Q 2025, there was a full quarter impact, but you guys at least seem to manage it effectively. Talk about how the LCD impact is trending just in terms of the magnitude of this impact. Are we seeing improvements? Is it worsening of late? Is it getting better? How is it sort of trending of late in terms of the impact more broadly on MIGS volume? It seems like, kind of the stacking headwind has already come from 15% all the way down to 5%. Maybe it's digesting a little quicker than anticipated. Maybe if you can talk about that.
Yeah, happy to. You know, first of all, what I would say is, you know, it kind of has to happen quickly because there is no payment associated with the stacked procedures anymore. That happening quickly is not a surprise to us. This is consistent with kind of what we had expected in terms of net impact here. Of course, the headwind will continue until we get all the way through the fourth quarter where we'll have the smallest headwind, and then the first quarter of 2026 is when we'll have the first, you know, kind of clean year-over-year comp. I think what's important is that we still are seeing, you know, in the trailing 12 month growth in total MIGS visits. In that, you know, mid to high single digit level.
You know, we did not see a fall off in visits associated with, you know, these changes in coverage, which, you know, previously, a few years ago when the stent reimbursement was cut, there also was a pullback in procedure volume initially. We did not see that here. That is a good indication that the market is healthy. They see a value in a place for MIGS in the treatment paradigm for these patients, and those patients are still getting care even without these stacked procedures. I think all of that has been, you know, relatively consistent with what we had expected really since the start of the first quarter, and we are just continuing to, you know, progress through this process.
Got it. That's great.
I think, I think stepping back a bit, just it's worth the reminder, glaucoma is world's leading cause of irreversible blindness. Minimally invasive glaucoma surgery is a proven treatment, whether it's canaloplasty or goniotomy or stents. The market is not fully penetrated. Combination cataract market is the majority of MIGS revenue today. There's still plenty of runway and market expansion available in combo cataract. There are hundreds of thousands of patients per year that have glaucoma and are undergoing cataract surgery that today are not getting a MIGS. There's an opportunity there, and we're working on that to expand the combo cataract segment. Obviously, we've discussed the standalone market opportunity at length, and there's, you know, millions of patients that can benefit from a minimally invasive procedural intervention sooner. It's a space that's here to stay.
I think the bar has been elevated and raised in terms of clinical requirements, and I think Omni's got a terrific product market fit in that regard. We feel good about the space over the long term.
Got it. That's great. Ali, you mentioned that patient visits really haven't deteriorated at all, which, at least we view very encouraging in the context of, as we lap these LCD headwinds to device unit volume, maybe we can return to at least some level of normal volume growth. Maybe if you can just talk to the U.S MIGS market longer term as we lap these headwinds kind of exiting this year, it sounds like just based on this kind of, call it MIGS eye growth, maybe we can get back to a normal level of market growth. Maybe if you can touch on that.
Yeah, happy to. You know, as you said, like we really start lapping the headwinds in the fourth quarter, fully lap it first quarter of 2026. You know, we're really focused on how do we make sure patients are getting treated at the right time for, you know, these very serious, you know, needs. One of our focuses is really on how do we make sure that unmet need of pseudophakic patients continues to see increased penetration. We also are focused on the combination cataract market. When we think about engagement with cataract surgeons, there's still a significant portion of patients that have glaucoma and have a cataract procedure in a given year, and, you know, almost half of them still don't get a MIGS procedure at the time of cataract surgery.
That's really a large potential, and we need to get to those surgeons to really understand why they aren't also trying to make an improvement on the glaucoma outside of the cataract procedure. We do think that we can see a return to growth here in the MIGS segment, both in the combination cataract kind of core market, as well as really addressing the standalone pseudophakic patient population that is highly underpenetrated at this point. Obviously, that will have to include a continued shift in mindset of surgeons, of their willingness to intervene procedurally to improve outcomes. I do think that we have confidence that this market can return to higher growth rates as we lap those MIGS stacking, but we as an industry also have to do work educating surgeons on why MIGS is an important part of the treatment paradigm.
Got it. That's great. A couple more on glaucoma. I'll shift back a little more near term, but for 2Q 2025, Ali, surgical glaucoma, you guided to revenue down, high single digit to low double digit %, year-over-year growth, revenue declined by only 6% in 1Q, and in this quarter in 2Q, you're facing an easier comp. Are there any factors we should be cognizant of that would drive a deceleration in year-over-year growth, as well as the two year stacks? Is it competition? Is it the LCD headwinds worsening? Is it maybe just simple conservatism? If you can touch on the 2Q guide, that'd be great.
Yeah. I mean, I think that's in the range of outcomes of what we saw in the first quarter. What I would say is that, you know, obviously the second quarter tends to be the highest quarter seasonally. Sometimes that can be impacted by summer vacations. I do think we wanted to be a little bit more conservative given competitive factors as well, timing of launches and making sure that we didn't get out ahead of the market. I think it is important to set appropriate revenue guidance and, you know, making sure that we don't get caught there.
The other thing I would note that I don't think is necessarily understood very well is that the headwind, as we talked about the stacked procedures, as we were running up to the deadline there, we saw an increase in stacked procedures in Q1 and Q2 and Q3 of 2025. The headwind of stacking procedures on a year-over-year comp basis actually peaks in Q3 of 2025, in terms of headwind. Q2 does see more stacked procedures than Q1 did, in that comparative comp. That, I think, is another factor that when we thought about guidance is part of it.
Okay. Okay. That's helpful. That makes sense. You mentioned new launches, maybe just to finish here on glaucoma, a VIA 360 from New World, kind of a new fairly direct competitor to Omni. You have talked in the past about potential trialing and that some of that had been contemplated in your outlook. Maybe if you can just briefly, briefly touch on how VIA 360 trialing has tracked relative to your expectations? I will have one more follow-up on glaucoma.
I'll jump in there on, just a reminder that we, we too have launched Omni Edge into the market, and our surgeon customers are very pleased. We've been listening to the market as the pioneers of the category, and we've been innovating on behalf of our surgeon customers and patients for a decade now. Omni Edge is the latest. It's being very well received. We're proud of that, and we continue to innovate on the Omni platform, as I mentioned, and Omni Edge will not be the last elegant ab interno canaloplasty or trabeculotomy device from Sight Sciences. Stay tuned for more. As it relates to competitive products, yeah, we've seen them, Tom, before, every, every, yeah. The ophthalmic community likes to try new things. I think that's, you know, consistent with most specialties. New products are released.
Let me try it. There's trialing disruption for sure. I think with any product, we've seen it in the past. In this case, I think there've been prior ab interno canaloplasty attempts here. None of those have really broken through into the mainstream. Time will tell. Yeah, there's trialing disruption. We had expected it. We knew that this product would be likely coming to market this year and have prepared accordingly. Again, we're doing, we feel very good about Omni Edge, and we are in ORs across the country today, delivering great clinical outcomes.
Got it. Got it. That's helpful. Last one on surgical glaucoma, and I want to leave some time for dry eye, but saw you commenced, I believe it was a pilot study on the Helix micro stent. Paul, maybe if you can talk about that product, its differentiating factors, and any rough sense for timelines, milestones, et cetera, that'd be very helpful.
Sure. Yeah. Sight Sciences actually, we started off as a canalicular scaffold company many, many years ago, shifted to non-implantable solutions, which ultimately resulted in Omni. Think of, to make a cardiovascular analogy, angioplasty and stent. Angioplasty came first in the 1970s, and then stents, bare metal stents came later in the 1980s and 1990s, and then drug-eluting stents. We shifted to Omni. I think that was a great decision. Omni has been transformative to the MIGS category, and now we are working to bring an elegant canalicular scaffold to market. As you mentioned, the Helix, I think the differentiating qualities, I think it, we're trying to ace both procedural ease and usability coupled with efficacy.
We have seen from the various stent products on the market, you know, some have better attributes on the procedural side, some have, you know, claim to have better efficacy from the circumferential approach. We are trying to marry the procedural ease of your favorite micro stent with the circumferential efficacy that comes with treating more of the diseased outflow pathway versus less. That is what you have in the Helix micro stent. It is a very elegant helical design, can be delivered into the canal in a very efficient and straightforward manner. It props open the canal effectively while minimizing contact with the walls of the canal, to ideally optimize outflow.
Got it. That's great. Super helpful. Shifting to dry eye, I'll dive right in, and Paul, maybe if you can start by talking about how payer discussions are going, any payers maybe in the later stages of discussions. You reiterated, on the 1Q call, expectations for 2025 payer wins. Do you still expect some to begin coming through this year? Maybe if we can start there.
Yeah, we remain very excited about the TearCare opportunity and the opportunity to pioneer a significant new category of interventional or procedural dry eye. There are no reimbursed treatments. Patients do not have reimbursed access to procedures that address the root underlying cause of the vast majority of their dry eye disease, which are obstructed meibomian glands. We are many years into a long-term strategy and a significant investment we've made, primarily with the Sahara RCT, two-year RCT in dry eye, which has concluded now. We are having very productive conversations with payers, Tom, as we've discussed in the past. Those conversations are progressing. This includes small commercial payers, large national commercial payers, as well as a handful of MACs. We have stage one and stage two of Sahara published. We have a budget impact model published.
We've completed stage three to two-year endpoint for Sahara. That is in the peer review process, and we expect publication this year along with a cost utility analysis. We have shared the high-level clinical outcomes of the two-year data at the recent ASCRS conference. The results were as we had expected and as we've seen over the years in the cash pay market, in the 65,000-plus cash pay cases that we've seen. TearCare is proven to be efficacious, consistently efficacious on all signs and all symptoms, not just immediately, but also over the long term. With that foundation of clinical data and the health economics that come with that, and the superiority to the leading prescription eye drop, we've really made a strong case for payers to want to cover this.
Better clinical outcomes for patients, better value to the system, better value for payers, value for patients, value for eye care providers, obviously value for Sight Sciences and shareholders as well. Because of that value that's readily apparent, our conversations have progressed nicely. We continue to state that we believe we will have coverage policies and/or payment decisions this year and 2025. Hopefully that's more than one. It will take several years to get, you know, complete coverage of, you know, all of the potential covered lives. But we think that, that first coverage policy and/or payment decision will be a very significant milestone in our journey to pioneer this new very significant category. I would say it's probably one of the biggest categories in all of medicine where the prevalence is already significant. It's growing.
Our obsession with screens and smartphones and Zoom, just like we're all on Zoom right now, it's exacerbating the problem. A publication out of Europe from some cornea professors in Europe called it a lifestyle epidemic. We have a very proven treatment with rigorous RCT data behind it to suggest intervening earlier with TearCare is good for patients immediately and over the long term. Again, stay tuned for some progress this year. We do believe we'll put up some coverage decisions, successful coverage decisions or payment decisions this year.
That's great. No, super compelling, super comprehensive. Appreciate that, Paul. You have talked about customers upon kind of coverage and/or payment decisions ramping quickly. You have smart hubs in the field today, but where does, remind us where the dry eye sales force stands today and how important is that to the ramp up as reimbursement starts to come through hopefully sometime this year?
Yeah, we have a lean infrastructure, commercial infrastructure with TearCare, but they're very tenured and that's important. We are not starting a, you know, this will not be a launch, cold into the market. We've been in this space for years, carefully paying close attention to it, learning a ton, understanding the market, understanding the customer, understanding office throughput, having long-term relationships with those customers. This team of 10-15, you know, maybe 10 reps, maybe 15 all in with marketing resources, while it's smaller, it's a highly effective lean team because of the tenure in the market and their expertise. I would say we've been more focused on procedural dry eye or interventional MGD than any other company out there over a long period of time.
When we get coverage and/or payment decisions, we have that installed base, as you mentioned, of 1,500 plus smart hubs trained. These folks have been trained on the TearCare procedure. We have reps that are ready to go. We have those established relationships. We have customers that are waiting, frankly, for the reimbursement determinations. We are excited about the kind of acceleration we can see. We will make investments as we go. We'll feel it out. We'll see how it's performing and the rate of acceleration and the opportunity to invest and grow better, faster. Again, we will not be starting from a standstill when we get the reimbursement.
Okay. Got it. Potential investments, i.e., maybe sales force expansion as you kind of feel out payment decisions coming through, but there is an openness to kind of scaling that sales force footprint.
There is, but I think most importantly, I think we're gonna have market performance in hand before we have to make those decisions because we have that existing customer base and that existing commercial infrastructure. So it's a lot easier to make informed investment decisions when you're already seeing, you really like what you see.
Got it. That makes perfect sense. I think we're at time, but I'll squeeze one more in if that's okay. Maybe just to wrap up here on dry eye, you know, we look back and at peak, your customers were performing roughly 20,000 total TearCare procedures annually, but cash pay likely had limitations just given cost constraints since the procedure out of pocket wasn't inexpensive. Have you quantified how the TAM may expand with coverage and reimbursement? Maybe if you can just talk to us about, you know, where volumes could escalate to, as you start to, you know, as these coverage and payer decisions start to come through.
Yeah, I'm happy to take that. We did peak at over 20,000 procedures in 2023, and in total, as we said, done about 65,000 procedures. We estimate there's over 19 million diagnosed patients in the United States with dry eye disease. Up to 86% of those have some form of MGD. That's, you know, up to almost 17 million patients, and about half of those are moderate to severe. That's, you know, call it 7 to 8 million patients. You know, that is a significant patient opportunity. We estimate one procedure per year for moderate patients, two procedures per year for severe patients. Now, obviously the actual TAM will depend on what the reimbursement rate is, and that's still TBD. This is a very large market opportunity. There's poor compliance with prescriptions and over-the-counter eye drops.
Not only is this a better solution for patients, much easier from a compliance perspective to go once or twice a year, it's a lower cost for payers, as we've shown in the budget impact analysis, and the providers can participate in the procedural economics. We think this is really a win, win, win in a huge, and as Paul said, growing market, where patients are really looking for a better option.
Got it. That's a great note to end on. Paul, Ali, thank you guys so much for participating, and hope you both have a great summer. Thanks.
Tom, thanks a lot. Appreciate it.
Take care.
Thanks, Tom.