Sight Sciences, Inc. (SGHT) Earnings Call Transcript & Summary

Perfect. Thank you very much, everyone. Really pleased today to have the team from Sight Sciences here. We've got Paul Badawi, CEO; and Ali Bauerlein, CFO. Thank you so much. Before we get started, I have to read you some fun disclosures here. So for important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures.

Paul, obviously, probably a bit busy day. Maybe provide us some high-level overviews of the update you provided to us yesterday.

On the LCD?

Let's start on the LCDs, and then we can get over to Matt afterwards.

Sure. Yes. So just a quick background on what's happening on the reimbursement front. In June, as many of you know, 5 of the MACs proposed noncoverage for a number of non-implantable glaucoma surgeries and procedures, including 2 of our products and procedures, OMNI and SION. We obviously believe that there is plenty of clinical evidence supporting our procedures, and we had a very effective, we believe, effective response throughout the summer. And the open comment period for all 5 MACs, comment period closed August 5. We presented plenty of clinical evidence, hundreds of surgeons who use our products every day to take care of their glaucoma patients, wrote in letters. There was very broad, strong society support. So we feel like the MACs have all of the evidence that they need clinically to make the correct determination on continued coverage, especially for the OMNI Surgical System. It's in their court now. The comment period closed August 5th. There are 5 MACs. This is maybe a little bit more complex, it might take them a little bit longer than it might otherwise if it was just 1 MAC as it was back in 2020, but we have to wait and see. We still have very strong conviction that we'll make it through this, and OMNI will continue to have coverage. We believe it's becoming a standard of care. Comprehensive and refractive cataract surgeons as well as glaucoma specialists use OMNI every day to take care of their glaucoma patients, and it's consistently delivering robust outcomes. That product procedure and those outcomes shouldn't be taken out of the hands of any surgeons.

And maybe just talk to us about the guidance cut. What's been driving that?

Yes. Happy to take that one. And obviously, yesterday, we announced that we did have to take down guidance and provided a guidance range for Q3 that was below expectations, both externally and also internally, where we were quite looking at coming in for the third quarter. And really, that is driven based on what we're seeing in terms of buying patterns in the quarter. And typically, we start with kind of seasonal slowness in the summer months, where July tends to be lower in terms of volumes with lower procedure volumes, and that is what we saw in July. And then typically, we see a rebound in August and September associated with more procedure volumes. And in August and September, thus far, we really haven't seen the same size of rebound that we've seen in prior periods. And so when we looked at where we were coming in for the quarter, it is a significant miss versus expectations. And that primarily is associated with reduced utilization and then secondarily, also the impact of fewer new surgeons being trained in the period as they await clarity on the MACs. And so those are the 2 items we are seeing significant and strong customer retention. So customers are still buying, but they're buying at lower rates than what we expected. And that's really the impact of the guidance change. And when we looked at what we're seeing in the third quarter, we thought that it was prudent to not extrapolate what we would normally see in the fourth quarter to be improved seasonality where typically, there are higher utilization of procedures in the fourth quarter versus the third quarter because of this LCD impact. We said it's -- when we are resetting guidance, let's just assume that level, that $19 million to $20-ish million is the appropriate level until we get resolution on the MACs. So that's why you saw not only Q3 guidance below expectations, but also a reset of the full year guidance because we are assuming in guidance that the MACs are -- provide clarity on the LCDs in time to have impact in 2023. Now from a practical standpoint, we do expect MAC resolution in the fourth quarter. That's our current expectations based on consultants and advice from people who are experts in this, but they are not required to respond in the fourth quarter. They could respond any time between now and June of 2024. So because of that uncertainty, we thought that, that was prudent from a guidance perspective to really set an appropriate level expectation moving forward.

And has there been any specific MACs in particular that the impact has been from? Or has it just been spread across all of them?

It's been relatively broad in nature although, of course, more concentrated with the 5 MACs that are experiencing these proposals on the LCD front.

And those docs that are currently, I guess, using competitor products, how are you planning to get those back come 2024, assuming the coverage is back in play?

Yes. I think it always comes down to clinical outcomes, usability. OMNI, again, our account retention has been very strong. OMNI is a necessary product for, again, comprehensive cataract and refractive surgeons in the more mild-to-moderate segment, and the glaucoma specialists use it typically on their more moderate-to-advanced patients. So we see the clinical utility of OMNI is going to continue, clarifying coverage will restore not account retention because that's there. For those use cases where a doctor has to have OMNI, those are still happening. Volumes are affected right now. And as Ali mentioned, training of new doctors is affected. We think that clarity on LCD remedies both of those things. If you look at our second quarter, we had our strongest quarter. So we were talking earlier in some of the investor meetings. In May, our outlook near-, mid-, long-term outlook on both everything we're doing in MIGS as well as everything we're doing in the dry eye space, our outlook was as good as it's ever been. So we can't wait to get back to the outlook that we had just a few months ago in May.

I know this is now like the second time an occurrence like this has happened. What needs to stop this from happening again in the future?

Yes. So the first time, Palmetto, I think you're referring to 2020, similar proposal. It was a 3-month process, started in September 2020, I believe. And by the end of November, they had pulled it down. This time, a lot of people ask why are they looking at it again if there was already a review. And we think that we believe there was a spike in claims in 2022, primarily on the goniotomy side. And any time there is a spike in claims, often that will trigger a review. I think this is a pretty thorough review, frankly. I think 5 MACs doing a deep dive, all of these open meeting, it's a rigorous process. We were happy that it was rigorous because we have very strong clinical data to share that was not considered. When these things were proposed in June, it was clear that all of the clinical evidence, frankly, we were successful proving our clinical evidence back in 2020. Since then, we're 3 years of clinical evidence stronger. We have a much stronger indication for use from the FDA. In fact, the irony in all of this, we have the strongest indication in the MIGS category. So OMNI is labeled for mild, moderate or advanced intervention in terms of severity of disease and regardless of lens status, phakic, combo cataract, pseudophakic. So we feel like we have presented everything that we can present. This review is extremely thorough, [ calm ]. And I think 5 MACs deep dive by all of them, we feel like hopefully, we come out of this soon. And I think the market would think this review was thorough, and I don't think there'll be a concern that this could happen any time because one, the review is thorough; two, we're not stopping on our clinical data generation, right? All of these OMNI cases getting done. Real-world data, we didn't talk about that. We've submitted for a 2-year publication on real-world evidence from the American Academy of Ophthalmology's IRIS Registry. We've pulled data from OMNI, and the 2 stent products in large scale looks very favorable for OMNI as expected due to its comprehensive mechanism of action, and now we're starting to look at the 3-year data. So when you think about this review, this did happen this summer and all of the clinical data that we already have and all of the clinical data that we're going to continue to generate at large scale, for me, it's almost impossible to understand how someone could then go back down the road and, again, argue that OMNI is investigational, okay. I can't comprehend that.

Yes. And now moving on to the other announcement yesterday. So Matt Link hired then as Chief Commercial Officer. Maybe talk to us about the process there and why you think Matt is the right guy.

Sure. Excited to talk about that. I'm excited to talk about growth. That's what we're all about. And I'd say we -- our bar is high. We're trying to build a leading eye care company. We've got 2 tremendous opportunities in MIGS as well as dry eye and pioneering market access in this category that needs -- patients need access to procedures that treat dry eye. So who's going to lead the growth of these 2 significant categories? Well, we had specific criteria, kind of looking for a unicorn, I'd say, and I think we did the same with Ali. When we searched earlier this year for our CFO, we wanted someone who had public experience, had scaled the business, had been very hands-on and operational and had seen a business grow, hopefully, into the hundreds of millions of dollars and have led that growth. Found Ali and fortunately, she decided to join Sight, and I think it's been tremendous ever since. And with Matt, similar criteria, right, who is someone who could take us from where we are today and help us scale into, hopefully, the hundreds of millions, if not beyond, somebody who has developed markets, someone who have changed practice patterns. And so we were looking for all these specific criteria, kind of looking for a needle in a haystack. Got introduced to Matt ultimately, and having looked at his history at NuVasive and then having met him personally. He started there, I think, as an area manager back in 2006. It was a small public company doing about $50 million in revenue, and had to prove to the world that the historical approaches to spine surgery could be different and better. Sounds familiar to what we're trying to do in glaucoma and dry eye. So they had pioneered a lateral approach to spine surgery. He helped drive that business and that growth over the coming years, from $50 million to well over $1 billion in revenue and developed a market and transformed patient care in the process. It's exactly what we want to do here at Sight. I think Matt is a perfect fit as our new CCO, and we're really looking forward to working with him and watching what he can do in terms of scaling our business. I think on a personal front, many of you probably already know Matt. Terrific guy as well.

Great. Moving on to products now. Maybe just talk to us about OMNI and what you're seeing there on the standalone and combination categories. Any trends worth calling out?

Well, if we step away from the current LCD, the general trends, we have been seeing good growth in both combo cataract and standalone. Standalone is obviously earlier days. We estimate that if overall, the MIGS market in terms of revenue today is probably 95% combo cataract; 5% standalone. Our mix is a little different since we are kind of pioneered the development of the standalone market. We estimate our mix is probably 85% combo cataract; OMNI, 15% standalone OMNI. But we're seeing growth. Again, it's off of a base of small numbers with roughly 25% to 30% growth consistently in standalone annually.

And what's the plan to take that standalone growth for the next level, away from alleviating those reimbursement pressures?

Yes. Continued education, continued messaging to the market, continued clinical evidence generation, sharing the clinical data that says, tells doctors intervening earlier on a standalone patient who might be on 2 meds, their pressures uncontrolled, you can either prescribe a third med or refer them to a glaucoma specialist for a more invasive surgery. It's so clear that the time is now for a minimally invasive, safe and effective, comprehensive MIGS procedure that can hopefully not only get patients' pressures down but also get them off of their meds. And so it's a lot of education. There's other players that are entering the market I think hopefully continue. Multiple companies educating the market, I think, will help. It's a $4 billion to $5 billion total market opportunity. It's 4 to 5x bigger than the current MIGS market, primarily MIGS performing combination with cataract surgery, which is estimated at $1 billion. So two tremendous growth opportunities. We're going to continue doing what we've been doing, which is educating the market, training surgeons on OMNI. As they get very familiar with OMNI, they get a lot of confidence in the consistent clinical outcomes. It's those consistent clinical outcomes that give our surgeons the confidence to have new kinds of discussions with new kinds of patients. You have glaucoma, you've already had cataract surgery, your pressure is rising, you're on a med or two. I've got a good surgical option for you called OMNI.

And looking at the MIGS market as a whole, I know a lot of activity on there on the pharma side at the moment for glaucoma. Do you think that could be a threat to the conversion over to surgical procedures?

I think MIGS arrived because there was a need. MIGS has never existed in the absence of medications, MIGS has never existed in the absence of lasers, MIGS has never existed in the absence of invasive surgery. It fits in between the noninvasive approaches which are meds and lasers, and the invasive approaches which are trabeculectomies, valves and filters. So I see those things as they live and they've always existed in harmony. I see them as complementary. I think we wish all the success in the world for sustained release. We think that it's the right way to deliver meds, but we view it more as a better way of delivering medications. And medications have always been around. I don't see that sustained release moving meds into another category.

Got you. That makes sense. And on SION, product released just over a year ago, I believe. How has that been performing? What are you seeing maybe? Any trends? Has that been cannibalizing any of the OMNI growth?

That's, again, LCDs aside, SION's trends have been great, not cannibalizing OMNI. It fits in the surgeon's tool kit. Again, OMNI was launched in 2018 in a market that already had goniotomy. So OMNI's never existed in a market that did not have goniotomy. So when we launched SION, we never had much concern about cannibalization because there's -- if we weren't going to win an account because of goniotomy or if OMNI wasn't going to be the preferred choice, that was already happening with those goniotomy accounts that preferred goniotomy for whatever reason. Maybe the surgeon was more comfortable with an easier procedure or the facility was more comfortable with goniotomy for whatever reason. So SION has fit nicely to help us get into those accounts or those cases where OMNI may not, for whatever reason, have had the strongest product market fit. And frankly, I think some of the data shows that in our -- in those accounts that we couldn't formally get in, where we get in with SION, we're actually able to convert some of those surgeons, at least part of their business over to OMNI. So helping us actually win OMNI business, yes.

So moving over to TearCare. I know there's a higher RCT, results were out recently, a good development there. Maybe some high-level thoughts on that, why the trial design, why RESTASIS?

Yes. Thanks. Another exciting topic for us right on the heels of our 6-month superiority endpoint. So we -- just to rewind, we -- this is our second RCT TearCare, our product for evaporative dry eye. It's one of the most prevalent problems in eye care. It's the leading cause of dry eye disease. Meibomian gland in your eyelids, they're oil-producing glands in the eyelids. When they're healthy, they produce a liquid oil called meibum. With every blink, a little bit of this liquid oil is expressed out of the glands, coat your tear, ensures that the tear has enough integrity to stick around long enough and protect the cornea. The market today is dominated by artificial tears and prescription Rx. And there's no reimbursement, there's -- patients don't have access to procedure for the eyelids for the meibomian glands, which is really the underlying cause of the majority of the patients who are suffering from dry eye disease. So we recognize that. We've got very elegant technology. It works really well. We've done a number of studies with TearCare, very consistent improvements in all signs and all symptoms across our studies. So we saw that we had something different. We saw that we could be ambitious and try to transform this category. How do we do that? We need to create patient access. We need to create reimbursement in this category so that millions of patients with dry eye can get these procedures. We talked to payers before designing the SAHARA RCT. We said what data do you need to see so that if we can deliver it, it will arrive -- you will arrive at a successful coverage determination? And their interest was randomized against the market leader, randomized against the product that they know very well, randomized against what they're paying the most for today, and that was RESTASIS. So we said, "Okay, we're going to randomize against RESTASIS. What endpoints do you need to see?" And they said, "Well, check signs and symptoms ideally show superiority and show durability of treatment effect." So how long does TearCare last? If we decide to cover it, how many procedures are we covering per year? So the study is a very robust, ambitious study. It's a 2-year trial in dry eye, unheard of. Our first endpoint we've already met, that was a 6-month superiority endpoint. We just announced it this summer, superior on the primary sign of tear breakup time. As it relates to the other signs and symptoms, TearCare showed clinically and statistically significant improvements in every single sign and every single symptom measured at every single time point. So very compelling clinical data. We're hoping to get it published by the end of the year. With that publication in hand and in parallel, a health economics analysis and publication that we're preparing, which should hopefully also be published by the end of the year, our market access team is super excited right now. They're planning for our market access strategy, kicking off first thing in 2024, where we're going to talk to payers and try to work on getting coverage for TearCare pioneering patient access, to evaporative dry eye, interventional dry eye procedures.

And longer term, how would you be thinking assuming those pay discussions go well about the mix between OMNI and TearCare?

I think long term, both are huge market opportunities for us. And what we've talked about is that on the TearCare side of the business, a $2.5 billion core addressable market here, really focused on patients with MGD with moderate-to-advanced MGD. And so that's really our focus out of the gate is this $2.5 billion market. Obviously, in the glaucoma side, we're addressing this $5 million -- $5 billion opportunity. So from both stage of the market, I would expect for the foreseeable future that the glaucoma side would be the bigger portion of the business. But I do expect, once we start getting some of those market access areas, that we could start seeing TearCare being a faster grower. And so when we think longer term in the 3 to 5 years out, that may be what you're kind of looking at, obviously, we're not giving specific guidance on that today. But both are very large opportunities for us, both are opportunities for us to have high growth in those areas and really be a market leader in those spaces. So that's what we're looking to execute, and I would expect both to be material contributors to our business over time.

Great. And obviously, a lot of activity in the dry eye market at the moment at Xiidra, Eysuvis. How do you plan to switch those existing treatment paradigms over to your unique asset in TearCare?

Yes. I think it's kind of similar to your previous question, Kallum, around OMNI and sustained release. Again, I think we love seeing all the innovation in any space we're in. I think meds getting better, generally a good thing. TearCare has -- again, has never existed in a market that didn't have a leading medication or several good medications or several great artificial tears. So I see those things as improving that standard, which is start someone off in an artificial tear. Not working, try a prescription. Not working, move to a procedure. Over time, will we move procedures earlier? Yes, I think so. But for now, moderate to advanced, as Ali mentioned, $2.5 billion market opportunity. We've got a lot of work to do to penetrate that market. The reality, again, these products do not address the root underlying cause. Ultimately, that the disease-obstructed meibomian glands, the inflamed meibomian glands can benefit from an interventional procedure. And so we have a lot of work to do and tremendous growth ahead of us in a noncompetitive segment. Will it one day get competitive where we're bumping into, moving to the left into mild to moderate? Yes, in due course, but that's years away and lots of value away.

Sure. Would there be any longer-term plans of comparing TearCare to these newer dry eye assets, these newer dry eye drugs?

Great question. When we were talking to -- we talked to, I think, 8 different insurance companies prior to the design of SAHARA a few years ago. And I was sure I went in thinking we're going to randomize against Xiidra because at the time, that was like the newer product that was poised to like take share and be the next big thing in dry eye. I was surprised to learn that the payers were all pretty unanimous saying do it against what we know most, what we've been covering the longest, the product that we spend the most on. And the feedback was, we'll kind of apply that whatever those clinical outcomes are just generally to TearCare versus prescription Rx. So from a payer perspective, I think this SAHARA trial is exactly what we need. From a market perspective, might we randomize against other products? Maybe. I think there's also an opportunity, frankly, to do studies where you're looking at the combinations of these things actually produce better outcomes. It doesn't need to be necessarily this or that. Who knows?

Okay. Great. International business, a small part of the company at the moment. And what's the plan to expand here? What's the strategy?

Yes. So on the international front, right now, our focus is the U.K. and Germany. Those are the markets where we're direct outside of the U.S. As you said, small business for us, growing business. We see large potential. Obviously, we see MIGS, in general, having success outside of the U.S. So our strategy will be to invest in market access in those areas. This will take time. It will take the appropriate clinical trials. It will take us really working with the various agencies in each of the countries to establish appropriate access. So this is part of our long-term plan and something that is part of our existing SG&A investments, but not something that we would expect to have material contributions in the near term. So something we're very excited about. But today, not prepared to talk about the next opportunities. We'll keep those to ourselves. And as we get closer to launches in markets, we'll be able to discuss those plans.

Great. And just on the thoughts of the direction of future investments, right, are you planning on getting any more products into the mix? Where is the key for you to invest in at the moment?

Very generally, we're a very innovative company. Our roots are in innovation. Founders of the company still here, our early engineers are still at Sight doing their thing. And I think we've proven our ability to innovate disruptively several times now across OMNI, TearCare and SION. And I'll say we've been thinking for years of better ways to solve some remaining important problems in glaucoma and dry eye. In the future, if you look far out, where do we want to build towards? Do we want to be the leading player in glaucoma and dry eye? We'd like to have a best if we don't want to do, me too anything. So whenever we innovate, the goal is disrupt and elevate the standard of care. So we'd like to have disruptive technology solutions ultimately at every stage, from first diagnosis to end-stage disease. We need to be thoughtful in how and when we get there. We're obviously focused right now on OMNI and SION and then TearCare reimbursement. But we are always thinking of better ways of doing things. We've got a pretty robust portfolio of IP, and things working in research mode and progressing nicely quietly. But in terms of like actual plans to step on the gas, I think moving target right now. Ali can maybe talk more about that, but right now, it's -- let's get through the LCDs and get back on our growth trajectory.

Absolutely. And final question, just over a minute left. What's something that you believe is important to the Sight Sciences story that investors typically ignore?

Well, it's harder right now in the face of these LCDs and some of the disruption we just talked about to remember the big picture here. And the best way to remember the big picture is, let's just go back to May prior to the LCDs. Team, on top of the world. OMNI, growing very nicely. SION, growing very nicely. TearCare, looking at the data, right? At that point, we were looking at the 6-month data. So OMNI, continuing to grow in combo cataract based on a differentiated efficacy profile. That differentiated efficacy profile lends itself to developing the standalone market effectively, where efficacy is the top determinant of product market fit. OMNI has the strongest product market in standalone where efficacy is critical. Evaporative dry eye, one of the top needs. As you know, you're seeing lots of new products in the space. A procedure, providing patients with access to a procedure has to happen. We're far ahead in that. We have a technology that's capable of creating reimbursement, and we have a thoughtful strategy that we've been investing behind to get there. We're way ahead of anybody. So there's so much to be excited about as we're building this leading eye care company. What are investors missing right now? I think it's hard for anybody in the face of this surprising LCD uncertainty that's calling OMNI investigational are hard to really wrap your head around that when we're thinking of it as we're building, we're developing a standard of care. We're furthest from something investigational.

Great. Paul, Ali, thank you so much. Really appreciate your time.

Thank you.

Thank you.