All right. Good afternoon, everybody. Thanks so much for joining us. My name's Matt O'Brien. I cover MedTech here at Piper. I'm really excited to have Sight Sciences here with us. From the company, we've got Paul, who's the CEO of the company, and then Ali, who is the CFO of the company. Thanks so much for making the trip all the way across the country for us. Appreciate it.
Thanks for having us.
Sure. So maybe starting, you know, just broader glaucoma landscape, you know, what do you think about, in terms of penetration in, in combo and then standalone? Where are we at today? And then I guess where are we going with that, especially on the standalone side?
Sure. I start off at the highest level. Glaucoma remains a significant unmet need in medicine. It's the world's leading cause of irreversible blindness. Standard of care is evolving. Historically, it was, you know, meds and lasers and invasive surgeries, and there's a need, an increasing need for procedural intervention that are safe, effective, and consistent and reliable, and can be employed earlier in the disease treatment progression. So I think that overall there remains a shift in the mindset of glaucoma surgeons to intervene earlier, procedurally. And so with that shift comes growth in combination cataract, comes growth in standalone. Obviously the combo cataract MIGS market is estimated at a billion-dollar market. It's more penetrated, estimated maybe 30%-40% penetrated. Standalone is a, you know, five- to six-billion-dollar market opportunity, less penetrated, growing.
I think with this increasing interventional mindset and education from Sight Sciences and other industry players helping to educate the surgeon community and the referring provider community, I think we can make a real difference in continuing to drive procedural adoption earlier in the treatment paradigm.
Got it. Are you still seeing most of the growth, those coming from combo cataract, or what are you seeing from the standalone side? And especially with OMNI, I mean, it would lend itself to both so well, but what are you seeing?
Yeah. I would normally it would be easier to answer that question in a normalized environment, hopefully soon. MIGS will be back into a normalized environment, but with the past year and the LCDs and the reimbursement disruption, it's a little trickier and that's still all have to settle. I'd say both combo cataract and standalone are growth segments, but there's some nuances in the coverage going forward with the LCDs that are now finalized as of November 17th, which is great because it provides a better understood pathway of what's being covered and what can be used to treat glaucoma patients. So on the one hand, that's more stable, but in the very near term, combinations of MIGS are being restricted.
Yep.
So we're moving from a multiple MIGS world in combination with cataract surgery to a one MIGS world in combination with cataract surgery. Now we obviously feel strongly that OMNI is the comprehensive procedure that it is, does quite well in a one MIGS world, but that's, that's gonna be a near-term headwind for everybody. So while combo cataract glaucoma patients are growing, maybe low double digits, the number of devices used isn't gonna follow that same growth trajectory because of that combination MIGS restriction.
Got it. And so how does OMNI fit in that situation? Because you're doing two procedures, right? But you don't get reimbursed for both of those. You only get one. So talk about the challenges there. And then do they typically use OMNI for canaloplasty or goniotomy? What do they do?
Yeah. So for OMNI, we feel very good that OMNI was designed to be comprehensive in nature. It's, I think the only MIGS device that's dually indicated, multimodal, multi-mechanistic. It's indication of canaloplasty followed by trabeculotomy. We designed it that way to offer the surgeon a device that would allow them to surgically intervene comprehensively with a single device that can address the disease trabecular meshwork, and the disease canal and disease collector channels. So when you shift from two MIGS to one MIGS, if you're using all of OMNI's functionality, you're already performing multiple mechanisms.
Yep.
Of action.
Okay.
So.
Got it. What about Q3 revenues? Came in basically where we were modeling, but the surgical glaucoma, you know, piece was a little bit softer than what we were modeling. Is that really a function of the LCDs not being finalized? And then now that they are finalized, you know, can we get to a point now where we're getting back to more clinical outcomes and just a more normalized, you know, growth rate from the surgical business?
Yeah. I'm happy to take that one. And, you know, Q3 was below our expectations in terms of our recovery as we've come out of this LCD uncertainty period. We did see lower utilization and lower accounts than we had expected in the period. However, it's a really dynamic environment with MIGS right now. Not only do we have the combination MIGS, changes in coverage, but we also have new competitive trialing and other factors, and a very dynamic environment. So we are working through those challenges. We think those are transient in nature, and we're focused on kind of the long-term opportunity, which we see as kind of multifactorial here.
We're obviously re-engaging with the accounts that we are, that we lost through the LCD process, getting those accounts back, working through those challenges with them, engaging new surgeons, working through, you know, why they should train on OMNI and the importance of that in the glaucoma treatment paradigm. We also, as we talked about on our earnings call, have a focused effort on, really having the standalone opportunity instead of being this giant $5 billion opportunity. How do we make that a compelling value proposition to our customers on why there are specific patients that they must treat? and that's really focused on patients that are multiple years past a cataract procedure, but are still seeing increased meds, increased pressures. These are patients that really need to be treated with a solution, not just another medication.
Yeah.
We're working with our surgeon partners to talk about these patients and not just put another med on them and have that interventional mindset and approach. We are taking a lot of different approaches. This will take some time for us to work through all of them, but we do believe in the long-term growth profile of the company and the compelling efficacy profile of OMNI.
Got it. Does that, I don't know if this question's for you, Paul, or not, but does that put you into the more moderate to severe patient population then if they're thinking about OMNI as a more comprehensive approach, and that kind of limits your opportunity in the mild to moderate group?
You know, if you look at the real-world evidence, we published, we analyzed glaucoma outcomes of the three leading MIGS procedures.
Yeah.
Two stents and OMNI.
Yep.
Actually, the patient's profile was split pretty evenly. There was significant use of OMNI in mild, moderate, and advanced. I'd say if you had to describe where it was skewed, yeah, OMNI was probably skewed more moderate to advanced, but there were still significant mild.
Yeah.
Stents were maybe skewed a little bit more mild to moderate, but OMNI is used in all severities.
Yeah.
Yeah. And this is not meant to be to say that we don't pursue standalone opportunities across the treatment spectrum here, but to really try and for surgeons who haven't adopted a standalone procedure mindset, don't want to do MIGS procedures in a standalone environment and just wanna do it combo cataract, to try and help them get over that hump of why this is an important part of the treatment.
Yep.
Paradigm. And if they're not treating those patients, they're really doing a disservice to them. So this is not meant to exclude other types of standalone, but to really help the market shift the mindset.
Okay. And then you mentioned, you know, some of the competitive dynamics that are going on. I mean, you've got Glaukos, they've got iDose, that's all the rage right now. Does it make it more difficult in pulling back clinicians just given, you know, the dynamic that's going on with iDose and a lot of clinical interest and economic interest in that product?
I think as it relates to sustained release, we believe in procedural interventions as opposed to daily eye drops.
Yeah.
Generally, and I think, I think the mindset shifting, the eye care provider's mindset to intervene earlier procedurally has to happen, and it is happening, and I think that's a good thing. It's a good thing, I think, for industry. It's a good thing for a glaucoma patient. It's a good thing for eye care providers themselves, so I think there is limited bandwidth and, you know, in terms of interactions with surgeons, so I think that, that sustained release has obviously had a lot of mind share lately. In terms of like direct competition, we're not seeing them, you know, competing directly.
Yeah. No, I just mean more, Paul, like just getting the physician's mind share, to be able to go out and really sell the benefits of OMNI.
Yeah. Which is clearly the best.
Yeah.
You know, efficacy technology that's out there. I think that's fair. I think there is a mind share. There's limited mind share available. And, we're obviously in the OR all day long, all the time, but, it's gonna get shared with other offerings. That's, that's natural.
Yeah. Okay. Fair enough. Device- intensive didn't come down as you were hoping for. Can you talk to us about how close you were to getting that, you know, that indication? And then, you know, what's been the response of users since that update?
Yeah. We were very close. The device offset threshold is 30%. We were just above it in the proposed rule. I mean, the code that is used for OMNI 66174, and it fell just below at 29.14%, I believe, in the final rule, which was unfortunate. Would've been a nice reimbursement tailwind on the facility side.
Yep.
For us, it's not a new headwind. It's a tailwind we didn't get. It's done annually. So we'll see what's proposed next summer.
Okay.
But we, you know, when we launched OMNI in 2018, it was with a comparable facility fee that we have today. So in terms of relative, you know, facility economic dynamics, we're in a relatively similar position.
Yeah.
We just didn't get the tailwind that we were hoping for.
Okay. And for.
But we do believe that OMNI deserves device- intensive status.
Yep.
That is, an expensive procedure and that it should qualify, but we're not the only product that builds canaloplasty.
Yep.
And so we're in a code that others use as well.
Okay.
So we will continue to work towards achieving device- intensive status for the things that we can control, in post.
Okay. Forgive me, I'm no reimbursement expert, which I'm sure you guys are at this point, after all this. But I mean, that delta from 31 down to 29.14, what caused that delta? And then how can you fix that for next year to get over the hump?
We think that in the proposed rule, they looked at a certain, you know, number of claims, and those claims suggested a device offset that was north of 30%. In the final rule, some additional claims must have been factored into their calculus, into the CMS equation, and those claims, unfortunately, if those new claims that came into the equation obviously, you know, would've pulled it down below the 30%.
Okay.
So what can we do, to help drive better probability of success with device- intensive going forward? Well, it's driven by the pricing of your device in the hospital setting. So ensuring that we maintain, as we always do, price discipline. We're a price discipline company generally, maintaining price discipline of OMNI in the hospital setting.
Okay.
two, making sure that the hospitals are submitting their claims when they use OMNI and submitting under 66174, that they're submitting to CMS accurately and that the cost of OMNI is captured clearly and accurately in those claim submissions. And then third, continuing to lead the category of canaloplasty to ensure that OMNI's pricing is driving the calculus in the device- intensive calculation. 'Cause as Ali mentioned, if there's lower price.
Yeah.
competition in that equation, it'll pull down the device offset.
Okay. And again, not to belabor this point, but aren't there a lot of other canaloplasty options out there? So you said you're trying to lead there, but if you don't have the most market share, then you can't. And then the number of claims is gonna be to the point where you can't get over that.
Yeah.
30%.
Yeah. No. Well, I think we created the category of ab interno canaloplasty. I think we're clearly the market leader. There are other players, often competing on price. There have been for a while, and there are some new ones. But I think we're still clearly like the standout market leader in the category.
Okay. Okay. All right. Fingers crossed there.
Yeah.
Ali, question for you. 2025 numbers. We're starting to get questions on this. Can you grow the surgical business double digits next year? Is that a good starting point for the surgical business?
Appreciate the question on 2025.
Yeah.
As you probably expected, we're not gonna provide 2025 guidance today. You know, we're obviously important for us to get back to growth here and understand that the market is evolving here. As we've talked about, the overall market for MIGS devices is growing in a healthy manner for patients. And then we have this headwind associated with the combo MIGS restrictions that will be a headwind for 2025.
Okay.
But we have this incredible opportunity on standalone that also should be growing next year as we pursue this market. So, we're not prepared to give any directional guidance on 2025, but we do think that we are putting the right foundation in place for us over time to continue to take share in both combo cataract and the standalone market opportunity. And of course, what we haven't talked about is the dry eye opportunity, which we think will also be an accelerant to growth as we get those market access wins. Of course, the big question is when those market access wins will come.
Got it. I will not push any further on that even though I want to. So let's go over to TearCare, which you did mention. Did you see a lot of stocking in Q3 as in front of the price increase?
We did see some stocking in the third quarter. Obviously, for those who aren't as familiar with it, we have price increase effective October 1st, increasing our list price to $1,200, really to reflect the value of the TearCare procedure, with the clinical efficacy and the budget impact analysis that we are finalizing now, so we do think that there was some level of that. Obviously, we tried to minimize that because the whole point is we want to be able to shift to a reimbursed market with appropriate reimbursement levels.
Okay.
And the purchases before were really to drive a cash pay type of market. But to us, that was a testament to how much people valued the TearCare procedure, that they were willing to stock up and buy and do these purchases in advance of the price change. And we also are really happy to see the engagement with the industry on pursuing these reimbursements, submitting claims, and trying to get a proper reimbursement established for this procedure, which we think is really the long-term value creation.
Yep.
So, we see that it was really a big positive. We didn't expect that level of interest, and that to us is, is a great sign for the future.
Okay. So maybe, should we expect the TearCare business then to be volatile the next several quarters until we get more reimbursement in place? Is that what you think about it?
Say that again?
Just the volatility of the TearCare business. I mean.
Oh.
What should we think about?
Yeah. So as we said, for the fourth quarter on our last earnings call, we expect less than $500,000 of revenue associated with TearCare after the price change effective October 1st. And that really is for a small volume of contracts still continuing at the lower rates as well as claims being processed for market access. And we would expect that level to continue until we get some reimbursement wins in place.
Okay, so Paul, you know, big kind of transition now to the TearCare side of things as far as strategically for the business in the future. You know, we've seen other devices here historically. Maybe a little bit helpful is just to talk about, you know, how TearCare measures up and why you're so confident in the outlook for that business.
Sure. You know, so TearCare, it's been a project we've been working on almost a decade now. We recognized early on the need for millions of dry eye patients to have access to safe and effective procedural interventions that address the root underlying cause of their dry eye disease. We spent, you know, years developing this technology to be the best dry eye procedural dry eye technology on the market. We believe that it is. We spoke with payers many, many years ago to make sure that we were addressing what their needs would be. And we asked them, "What clinical data do you need to see? This is the state of affairs in dry eye. It's mostly artificial tears. Then patients move to costly prescription Rx. You're paying a lot for that, by the way.
And these procedures with TearCare, we think, are more effective. And we're willing to do a randomized controlled trial to prove that. and patients need to have access. So we asked them, "What data do you need to see to effectively cover and pay for TearCare procedures?" They wanted us to do a randomized study against the market-leading prescription therapeutic, which is Restasis. And they also wanted us to show them durability of treatment effect. How long does the TearCare procedure last? How many TearCare procedures are we gonna be paying for on an average patient per year? And so that's why we designed a two-year highly rigorous RCT, SAHARA. Last patient, last visit, two-year endpoint was completed in October. We've published the six-month endpoint that has superiority on our primary endpoint.
signs, tear breakup time versus Restasis, clinically and statistically significant improvements on all signs and symptoms at six months, crossed over all the Restasis patients at six months, gave them a TearCare treatment, looked at their signs and symptoms at 12 months, clinically and statistically significant improvements again at 12 months, and now we're working on the final 24-month publication, so we are in a class of our own. We have been persistent in making significant investments in developing this category the right way, so I think we have better technology. I think we've demonstrated more rigorous, robust clinical outcomes compared to the standard of care. I don't think anyone has done that, and I don't think it's easy to do, and so when we create this category and when we're successful with reimbursement, others will indeed want to enter this significant category that we're gonna create.
It will be challenging in terms of the clinical bar that we're setting.
Yep.
Because we again the technology works like OMNI, which is comprehensive to the disease glaucoma outflow pathway. TearCare is also very comprehensive in addressing the root underlying cause of disease, obstructed meibomian glands, and clearing those glands comprehensively, very consistently across a broad base of patients.
Got it. And so you've been talking to these payers for a while now. They've told you what to do. You've done it. What can we think about in terms of coverage over the next year or so?
Yeah. So we have been having productive conversations with payers. Their response to the SAHARA RCT has been a favorable one. Not that that was a surprise, but it's nice to now be able to have those conversations and say, "Here is a significant RCT," not randomized against saline or vehicle control like most dry eye trials, but randomized against the therapeutic standard of care, the gold standard. So those conversations have been going very well. We have said, you know, leading up to those conversations earlier this year that we would have expected payer wins in 2025. Now that we're having those conversations, we continue to believe that we will have coverage policy wins in 2025, probably the back half of 2025. These things aren't predictable in terms of their timing, but in terms of the quality of the conversations, they're going as expected.
Okay. So you get coverage in 2025, and then payment and everything kind of gets into place in 2026. So TearCare can start to be a much more meaningful contributor in 2026. Is that the expectation?
I think with coverage would come payment.
Yeah. Okay.
When we get coverage wins, we'll be able to begin building the business. Now, we don't need to make significant investments like one normally would need to do if it was a product launch from scratch. The reality is we've been out in the market for several years now in a cash pay mode to set up an effective reimbursed launch and an effective execution of the SAHARA clinical trial and to have a number of dry eye KOLs help us with our reimbursement engagements. We've been in the cash pay world. We've been in the dry eye market for some time. We have 1,000 eye care providers, ophthalmologists, optometrists who have already been trained on TearCare. We've done over 60,000 procedures. The product-market fit is checked.
Yeah.
You know, proven. Doctors love using TearCare. Patients benefit from it immediately and for the long term. What's needed to unlock this market is reimbursement. I think we have the clinical data to support it. And so when we get that first coverage policy win, I think we can expect to see revenue accelerating soon thereafter.
Got it.
Now, in terms of when does it become a substantial business, depends on the total covered lives, which payers we win first. But it should start to scale, you know, as soon as we get that first coverage win and then meaningfully 2026, 2027, 2028.
Got it. Okay. All right. Fingers crossed there. Ali, Hydrus litigation, I think you're owed about $34 million. Is that right? And then where are we at on that? What kind of timeline can we think about in terms of you getting that?
Yeah, sure. So we had a successful jury trial verdict in April of this year for $34 million of damages incurred through trial. So there has not been any ruling on confirming that verdict yet. That is expected this month. So December is when the hearing will be. And we would expect shortly thereafter some type of ruling on this as well as any enhancements or any ongoing royalties or other remedies. So that is pending, but there should be some progress on that in the near term. And, of course, that ruling is subject to appeal.
Sure.
You know, we continue to feel very good about our position in the case.
Got it. Okay. All right. I'm looking at the clock. I took us a little over. So I'll have to cap it there.