Tarsus Pharmaceuticals, Inc. (TARS) Earnings Call Transcript & Summary

Good day, and welcome to the Revolutionizing Treatment for Demodex Blepharitis Patients Conference Call. [Operator Instructions] As a reminder, this call may be recorded. I would now like to turn the call over to David Nakasone, Head of Investor Relations. You may begin.

Thank you, Michelle. I would like to draw your attention to Slide 2, which contains our forward-looking language statement. We will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. With that, I'd like to turn the call over to Bobby, our President and Chief Executive Officer. Bobby?

Thank you very much, David. So I'm Bobak Azamian. I'm the CEO of Tarsus Pharmaceuticals, and I focused my career on solving important unserved diseases by building innovative therapeutics companies. And we aim to do just this at Tarsus to bring an innovative approach to pharma in eye care. We started with Demodex blepharitis, which affects 25 million Americans with no approved drug today, and we'll talk about this in detail today. Today marks a turning point for Tarsus and Demodex blepharitis as interest and awareness is building and enthusiasm is also building for our potential treatment for Demodex blepharitis, which is TP-03, and we're seeing this interest build across a range of eye care doctors. Today, I'm honored to have participating with us some of the very best doctors in eye care and great friends of Tarsus. Dr. Eric Donnenfeld, Dr. Paul Karpecki and Dr. Elizabeth Yeu. They will share their perspectives and personal experiences with Demodex blepharitis in their patients today. This webinar illustrates a collaboration between ophthalmology and optometry. Today that will be very important to serve Demodex blepharitis patients in the future. Since these patients, as you learn, are being seen actively in both clinical settings. In terms of our agenda, we're going to cover some of the common questions. How prevalent is Demodex blepharitis? How significant is Demodex blepharitis to patients in their daily life? Also in the clinics, which patients should doctors be looking for? And how can any doctor diagnose Demodex blepharitis quickly and simply by looking for a pathognomonic sign of this disease, a specific sign that is called collarettes. We'll talk about TP-03, our investigational drug, which is a highly effective novel drug in an easy and convenient eye drop. We'll share results from the pivotal Saturn-1 clinical trial. And these results show complete resolution of the signs of Demodex blepharitis and really set a precedent in this field. This webinar is also very timely because our second pivotal trial, the Saturn-2 Phase III trial has just completed enrollment with top line data to come in April followed by NDA submission. If successful, this will make TP-03, the first FDA-approved drug for Demodex blepharitis. We're not only developing TP-03 for Demodex blepharitis, but we also have a pipeline becoming real in 2022 with proof-of-concept trials starting and reading out across a range of other unmet need and important diseases with our best-in-class antiparasitic drug. But for now, let's get into Demodex blepharitis, so let's get started. First off, it's my honor to introduce Dr. Eric Donnenfeld. Dr. Donnenfeld currently serves as cornea, laser, cataract and refractive surgeon with OCLI vision. He is considered a pioneer in cornea and refractive surgery techniques. He has participated in over 40 FDA studies, authored more than 190 papers on cornea external disease than cataract or refractive surgery. And currently serves on the editorial board of 9 journals. Dr. Donnenfeld serves on the Executive Committee and is former President of the American Society of Cataract and Refractive Surgeons, ASCRS, which is the largest anterior segment society. He has been named America's #1 eye Doctor in 2021 by Newsweek based on quality of care, continuity of care and the quality of the technology used in his practice. It's really been an honor to get to know Eric over the past couple of years with the introduction of Dr. Elizabeth Yeu who you also meet, and I can think of no better person to talk about how widespread and important Demodex blepharitis is. Eric?

Thank you very much, Bobby. I appreciate the very kind introduction, and I'm just very pleased to be here today. My whole career has been served by looking for places where we can make a difference in patients' lives, and I truly believe that 1 of the most underserved markets is dry eye. Dry eye is the single most common reason why patients come into an eye Doctor's office. And we have a variety of drugs that are now approved by the FDA to treat dry eye, but one of the problems is that despite the therapies we have now, we really have not gotten a handle on managing dry eye sufficiently, and it still is an incredible problem affecting tens of millions of Americans on a daily basis. And that's why when I began to understand the importance of Demodex blepharitis, I started to believe that this could make a true difference in the way we manage them on the most common reason why patients come into our doctors' offices, and we can improve on the therapies that we're doing right now. Demodex is a large underserved market in eye care. It's estimated that there are 25 million Americans today who have Demodex blepharitis. Now previously, Demodex was considered to be a commensal organism, an organism, a parasite essentially living in our bodies that didn't really affect our bodies in a significant way. This has been the traditional understanding that's been around for a decade after decade. Now when you see the data that will be presented today, you'll understand why this is just not the case. Demodex blepharitis is an important part of managing ocular surface disease and arguably the single most important part of managing dry disease. And that's why the advent of a new therapy is so important. Demodex is caused by the infestation of Demodex. It's pathognomonic with collarettes, little expresses along the base elastins that tell you that you have might underneath, and patients suffer from eye lid itching and burning blurred vision and a negative impacts daily life, and it goes on for decades. Looking at the original study, the Titan study that looked at the incidence of blepharitis in an enroll population, it's postulated that there are 1.5 million blepharitis patients who have Demodex, another over 1 million who have dry eye, 2.2 million who have cataracts, 2.3 million who have contact lenses and another 18 million leading to an estimation that there are probably 25 million Americans who have Demodex blepharitis. Next slide, please, Bobby. So in the Titan study, there were 1,000 patients that were looked at. This was taken from optometric and ophthalmic practices, and it was a retrospective study that looked at the incidence of these diseases and patients coming in to routine visits. And what we found here as you see is that, there is a preponderance of patients who come in who have collarettes. 58% of patients coming in for routine visits have collarettes. And this is exactly the number of patients who also have dry eye as well. If you look at the overall population, 68% of the patients had overlap with blepharitis, 62% with dry eye and 55% of patients have mites. So Demodex and Demodex blepharitis are seen extraordinarily commonly in patients who are coming into our office on a routine basis who have a diagnosis of blepharitis, dry eye, patients come in for cataract surgery or patients who are coming in who are contact lens users. Next slide, please. Well, why is Demodex important? These are examples of the effect of Demodex on the ocular surface and Paul Karpecki contributed -- made this slide by -- reference and he'll be speaking later, and he's again, 1 of the world's experts in really my go to optometrists when I have an optometric question that I really want to have answered. But some of these slides just show the effect on the ocular surface. Well, first of all, erythema. Redness in and of itself doesn't sound like a very serious symptom, but patients take this very seriously. Patients who come in with red eyes feel cosmetically disadvantaged. I've had patients come in and they say they -- people say they look they've been drinking all night, their eyes are irritated, they're red. This is a classic finding in Demodex. There is an infection or an inflammation of lid called hordeolum or chalazion, that are very common, and Demodex plays a central role in development of these inflammation of lid margin that cause swelling and irritation. Our corneal scarring can occur associated with dry eye irritation and staph blepharitis also associated with Demodex. And finally, [indiscernible] rolls on to the content type on to the cornea are very commonly seen in the patients who have Demodex as well. So Demodex plays essential role in the most common ocular surface diseases that clinicians see on a daily basis. Next slide, please. So the follow-up to the Titan study was the Atlas study. And this was a multi-study observational analysis of patients who had Demodex blepharitis to evaluate the impact of Demodex on disease. Again, I was 1 of the believers 10 years ago that Demodex was a conventional organism that didn't really affect the ocular surfaces very much. And I was completely wrong, which is why I'm here today because I think this is an important message that we need to educate clinicians on about the importance of Demodex and how it actually impacts on patients' daily lives. Patients feel conscious of their eyes all day long. They have difficulty driving at night. They do additional lid hygiene. They think their eye lids look ugly. They consistently worry about their eyes or their eyelids and they have difficulty wearing makeup most of them among women. 80% of patients say that Demodex blepharitis negatively affects their lives. And this is not a short-term negative impact on their lives. This is a lifetime of this company and irritation that they have not been able to be treated with effectively. The single most common symptom that patients have with Demodex blepharitis is itching. And for, again, decades, we all believe that itching was a pathognomonic sign of allergy. Again, we were wrong. Itching of the lid margin itself is Demodex until proven otherwise. All those patients who weren't responding to antihistamines, all those patients were responding to tears because they had Demodex now have a solution in the future that can help resolve their problems. The second most common problem that was associated with Demodex is dryness. These are very bothersome symptoms that affect people on a routine basis. Next slide, please. Finally, I want to close my section here by saying that Demodex blepharitis is a serious burden to patients and the health care system. The Atlas study showed that patients who had Demodex blepharitis reported that they had a negative experience with the disease with half of them having symptoms for greater than 4 years. This is an opportunity for eye care professionals to change patients' lives there is nothing more rewarding than seen in the patients who've seen 4 or 5 different doctors has never had relief of their symptoms has never been diagnosed appropriately. And suddenly, they come in to a doctor who recognize the disease and hopefully, in the near future, for the first time, will have a therapy to treat their disease. Many patients are actually never even diagnosed with blepharitis, so that there is a significant burden to patients, patients have been diagnosed incorrectly or not diagnosed at all because they're not diagnosed correctly, they haven't been treated effectively. And the idea that we'll have a new therapy in the very near future, called, which will be able to treat Demodex blepharitis, which you'll hear about later on from my colleague, Liz Yeu offers an extraordinary advantage, which I believe will be a milestone event in the development of dry eye. I have been privileged to be part of the FDA trials of maybe a dozen FDA trials involved in tri-IOs. It was 1 of the original researchers with restasis and cyclosporine, I actually was 1 of the first people to use Xiidra. And when we first started using these medications, we had to explain the ophthalmologists and optometrists that inflammation played a significant role in dry eye. That was considered heresy at the time and now is considered standard of care. I believe that treating Demodex blepharitis, which was something that we never really even thought about a couple of years ago, well, again, just like the anti-inflammatory, cyclosporine, restasis and Xiidra will become main stem therapies, which will be used repeatedly and constantly to manage a chronic disease, which we haven't had good release for in the past. With that, Bobby, thank you, and I'll turn the slide deck over to you.

Thank you, Eric. Just a very compelling description of how common this is, how it matters in patients and really some of your experiences over the years that suggest Demodex blepharitis is trying to be a really important disease. So with that, I will introduce Paul Karpecki. So Dr. Karpecki currently serves as Director of Cornea and External Disease at Kentucky Eye Institute. He's also an Associate Professor of the Kentucky College of Optometry, at the University of Pikeville as a Medical Director for Kepler Vision. Dr. Karpecki has over 20 years of experience running 1 of the most expensive cornea and ocular surface plants in the U.S. and is a leader and pioneer in this dedicated area of optometry. He is also the Chief Clinical Editor for Review of Optometry, profession's most read journal and is on the Board of the charitable organization Optometry Giving Sight. Paul is actually 1 of the first doctors that we turned to a Tarsus about Demodex blepharitis. And this demonstrates the deep knowledge and passion that optometry brings to Demodex blepharitis and his diagnosis. And Paul will just masterfully speak to how simple it is for doctors to diagnose this by having patients look down. So Paul, I'll turn to you.

Thanks, Dr. Donnenfeld. A great introduction, Bobby, I'm honored. And I always love hearing Dr. Donnenfeld. He takes all this complex information and hones into the really key points that are so critical to our understanding of this. It's a true sign of intelligence when people can get to that level. I'm going to try to do the same thing here as I focus on kind of that diagnostic component that is that looking for Demodex. And I love the phrase maybe hiding in plain sight because the fascinating thing for me is that this is 1 of the more easy diagnostic diseases we can make, meaning that we don't have to have extra equipment. Every doctor already has the key equipment to look for it. We just have to look for 1 key sign, which he already described, and that is what we call collarettes. But I like the idea of hiding in plain sight because if you look at this image to your right here, you can't tell the patient has any pathology of the eye lids. You can't tell if there's a disease there or an infection or anything going on. Because what's great about Demodex in particular, is that the key signs are at the base lashes. It's only 1 place to look at. And as I mentioned, every doctor has a slit lab, which is your microscope to look at the eyes. So you don't have to add in anything. I remember the very first time I was introduced to making this diagnosis, probably close to 2 decades and I was visiting a top researcher and clinician named Donald Korb in Boston. And I was trying to learn what to do to build my dry eye clinic at that time and understand where it played a role and he was welcoming to his offset, flying down there and spending the day and he had a patient slightly look down. And he said, what you think that is? And I likely I'd remember enough from seeing textbooks and stuff and I said, is that Demodex. He said, "Yes." And it was my aha moment, my wow, that is all you have to look for. That is it. Then I went back to my clinic and now it's been over 20 years. I look for that on every patient. And I'm fascinated by how accurate that Titan study that Eric described with a 58% of patients having collarettes, which is pathognomonic for Demodex as being present. And certainly, it's the #1 form of blepharitis he mentioned in his clinic. It's also the #1 form of blepharitis in my clinic, but you can't see it there. But if you will have the patient simply look down slightly and you look at the base of the lashes, it's evident that you see it quite readily. And these are the collarettes. Look at those dots that are right at the base of the lashes. That's all you need to look for. And there is so much similarity here to dry eye or people talk about blepharitis is similar to dry eye, but there's 1 really significant difference -- and that is the dry eye, well, is complex. That's I've been working on it for more than 2 decades. And it still is a challenge and more challenged than almost anything I see in my cornea practice. And yet it is -- it requires extra testing and extra dice and all this stuff. And that's not the case here. In contrast to Demodex blepharitis, it doesn't require extra testing. It's not extremely complex, it requires 1 simple thing, and that's to look slightly down and just scan the base of the lashes. And there you see it, pathognomonic. In fact, as Eric said, if you have collarettes, you have Demodex blepharitis because what that is is a combination of the debris, the eggs, the tails of the Demodex might are all part of that little nub, so to speak, what we call collarettes at the base of the lash that clearly surrounds the lashes itself. Now it can get inside the oil glands as well, but this is so easy to make the diagnosis as we look at it at and its present here, and we know what it is. Just a slight change in a routine slit lab exam, no extra equipment what we're always doing and using -- and now we just have the patient look down. I love the expression when I'm training residents and fellows and they have their first time, first day because we're going to see at the very first day they're with me or with anyone. And they have the patient looks down like there it is, and they never forget it from that point. And that's what's going to make this so exciting. I think the most exciting technologies in my mind, the most exciting therapeutics are those where there's not complexity in making the diagnosis. I think that's why we don't therapeutically treat as many triage patients as we should because the complexity evident. That's not the case here because it's so easy to make this diagnosis. Doctors are going to pick up immediately. And then in the future, they're going to know they treated with lotilaner. Next slide, please. I did look at -- we talked about this pathognomonic sign. What are these collarettes. You can see 3 easy examples even you, as investors, about taking away from your medical sales, but you could see clearly what's going on here. You don't need a degree in eye care medicine or foundry ophthalmology to be able to pick that up. That's how obvious it is. And you can see in all 3 of these, it's present, that wouldn't be there if you didn't have Demodex blepharitis. The collarettes are composed of what we talked about, excremental waste products, they're the eggs, the knits. They are the epithelial cells, keratin that gets formed and can cover some of even the glands that are -- it contains digestive enzymes, but the point is this is a very easy diagnosis. 100% of the time, if you see collarettes, you have Demodex. There's no other -- or 2 and as mentioned earlier, 58% of eye care patients. 50% of patients who show up, whether it's for glasses or surgery or cataract evaluation or dry eye or their eyelids or itching, as Eric described, will have collarettes present. It's all comers, not just those who have itching alone. It's everybody who enters the optometric or ophthalmology office. So our task is simple education. We don't have to say you need to get new equipment. We don't have to say you need to have specialized dies. You don't have to have anything specialized. You've already got everything you need to diagnose to Demodex blepharitis, in fact just slit lab. But instead of looking straight on the patient and have them look slightly down. And there you see it in all 3 examples have a patient looking down. You can make that decision instantly. It's a very compelling visual and very easy and obvious to make the diagnosis. And I think that's -- that's half the key to success with therapeutics. If it's going to be complex, doctors won't get us involved as perhaps they could or they are too busy. They look at other things. This is the kind of simplicity. This is the kind of aha moments that they're looking for. This will drive a lot of the diagnosis which then drives the treatment. Next slide. Now having said that, if you take a look at a subset, which is part of the same Titan study that we looked at earlier, these were patients, let me say, 58% of all comers had collarettes when they present to an ophthalmology or optometry office. So that's just across the board. Now what's really interesting is that of the patients who are on tea tree, which has been our previous treatment for Demodex blepharitis an over-the-counter product, that you can apply to the eye lids or lid wipes. These are kind of a surfactant lid way cleaning that they used to brush off the breed that sort of thing. Amazingly, and you would think these numbers are anything, but 75% of the people who are on tea tree oil which is what we use to treat this condition, still had collarettes, still had active Demodex. And 57% of patients who are on lid scrubs, which doctors knew to make a diagnosis and say, we need the clean lids, still had collarettes present. So this tells us that the current options are at best partially effective. High percentage of collarettes observed in patient populations using the treatments we know to go to today as our, hopefully, most effective today options and look at how little of the Demodex they have cleared. So we know that there's great need for something. And if I take it even further, these agents, some of them like tea tree cause stinging and burning. Some can actually be toxic at certain concentrations and it themselves with chronic use -- and all of this can lead to damage of your oil glands over time. And so there's a huge need for a therapeutic agent that can treat and eradicate Demodex blepharitis. Obviously, what we have today is partially effective at best. Let me take you through a case study. I think this helps put in perspective a lot of what we're seeing on a regular basis. I'm going to get the first 1 since I'm already speaking, and then Dr. Donnenfeld is going to take the second 1 around a surgical patient. So let me show you a very common patient that presents in my clinic. And I'm not exaggerating. I would tell you that I probably saw as many as 20 of these patients this morning out of about 30 patients I saw before this call. And if you take a look at the image on the left, it's really hard to see the disease. A couple of reasons why. First of all, he has a little bit of loose skin on the eye lids. We call that dermatochalasis. But it means with age, things sag a little, and that's covering the lashes. But I'll tell you, even if I lifted that up, you wouldn't see Demodex very readily. But look at how easy it is to see it as the patient looks slightly down. And almost every lash is involved. This is a patient that was first sent to me over 4.5 years ago that had seen numerous doctors and had tried every possible treatment to date. I'd love to say that we've got a treatment for them now, but we don't. That's what we're waiting on the law to enter. But let me tell you, to show you a little bit of the history because this is real common with what almost all doctors deal with when we're managing this condition. Next slide. So looking at this history, 73-year-old gentlemen, secondary complaint of itching as Dr. Donnenfeld described so well. We actually think that was allergy, but what we have to ask the patient is where is the itching and they'll indicate their lashes, they'll kind of show move over the finger back and forth right on the lid lash area, and we now wait a minute, that's Demodex as opposed to in the corner, which could be allergies and tiering, he had mild levels, which is interesting because you look at how much debris and collarettes to be specific, are present, those are classic almost every lash is involved, and yet he described his symptoms as modern. And that's what makes this so wonderful is we only have to look for 1 sign. We don't have to dig into symptoms as much and dig into all these other components and no extra equipment. We just look for 1 thing with equipment we already have. The condition has been present for 3 years before the time I've seen him. I've seen him for 4 years since. So we're talking 7 years now. It seemed 2 previous doctors who had tried some of the current treatments like lids scrubs when you saw the Titan data on that and with little improvement. He had slightly high osmolarity, meaning some dryness that was in his eyes. He's using artificial tears, gels at night and he scrubs his eyes daily, at least once or twice a day. His vision is not correctable to 2020, and that's real common when this acts on the oil glands and affects the tear film. And that's a blurred vision, he's talking about that fluctuates as he blinks. Next slide. So what we'll see here is his most recent picture. So fast forward 4 years, and you're looking at that and you're saying, well, I guess it's a little better. Well, there's a couple of things that stand out in this image. One, slightly better, but not much. Most of the lashes still have collarettes present. And what's worse is he has more of a scalloped eyelid margin today. You can see that it's just much more irregular, and that's where it's damaging the tissue. And as Dr. Donnenfeld showed in earlier trials, very clear from the data that Demodex patients have significant impact on many aspects of their life. The quality of life, how they look, their redness, look at this lid and how thin the lashes are over time. And we've tried everything we knew of today. When we did an in-office treatment where we could use this high-speed device, it's very effective to treat some forms of blepharitis, it would clear it, but it would return and the patient would come back within about 2 months on average, 3 months if we were lucky. We tried tea tree. We tried lid scrubs, everything that we showed you in the earlier state. His most recent visit, as you see here is what we have. And this is very typical, there's no current truly effective options for this most common disease. His vision is still not correctable to 2020. His osmolarity is still high. And his eye lid margins probably look worse, as do as lashes, even though we might have treated a little bit of the collarettes. But I wanted to share this case because this is so common. It emphasizes 3 things. Number one, we don't have a good treatment. Number two, these patients continue to have further loss of quality of life and effects on their lid margins and on their lashes and women's lash is thin and fall out, which they never like have happened nor do man for that fact. And number three, just how easy it is to make the diagnosis now and even with the beginning, but how much we need a true therapeutic agent like lotilaner that can eradicate Demodex. With that, let me pass it back over to Dr. Donnenfeld.

Thanks, Paul. Great case. I'm going to do another case. I'll do a little more quickly. Just really outline exactly what I think everyone needs to know from an investment perspective. And this is just an everyday bread and butter case that would come into my office. And 1 of the things that I've learned after a decade is that all of the technologies we have in our ophthalmology, all the recent advances in multifocal lenses, femtosecond lasers, Lasik, all of these advances fade when the ocular surface is not good. If you have a port tear film, this gene is never the same. And I always have a saying from the bumper sticker, I put on my car. And that is vision starts with a tear film. So when a patient comes in for cataract or a Lasik evaluation for that matter, the first thing I do is I look at the tear film. And this is a 66-year-old male who presented for cataract evaluation in the history of chronic ocular irritation, I see about 10 patients like this every day. Vision was pretty good, but the glare was worsening, the patient complains of a foreign sensation and itching that path and amount of sign I told you about with redness upon awakening. The patient comes in for cataract evaluation, but has an ocular surface problem, what's advance. So the patient came in, and this was the history, and this is a history I see every day and Dr. Karpecki and Dr. Yeu, I'm sure, see exactly the same thing that I'm showing you right now. The patient had seen 6 eye doctors previously. They've seen doctors for relief of their chronic ocular irritation and the patients have been diagnosed with allergy. They have been diagnosed with dry eye, they had been diagnosed with Meibomian gland dysfunction. They've been treating with topical antihistamines and corticosteroids. They've been treated with Restasis and Xiidra. They've been treated from a Meibomian gland disease with hot compresses oral omega-3s and oral doxycycline. And with this patient had in common with all the doctors they've seen is that no 1 had made the diagnosis correctly and no one treated the patient appropriately. The patient came to see us. We diagnosed Demodex blepharitis, we treated Demodex blepharitis. The patient responded to conservative therapy with what we have available today. In the future, hopefully, will have much better therapy to treat this disease. The patient who responds to therapy, had uneventful cataract surgery sees well. And not only does the patient see well the patient now has white quiet eyes cosmetically, they look better, they feel better and they're able to function better. This is a story that's been repeated hundreds of thousands of times around the United States and just emphasizes that we need to train doctors to look for Demodex. And once we have a therapy, we can treat them effectively. I think this is going to be an amazing opportunity for our eye care professionals and our patients. Thank you.

Thank you so much Dr. Donnenfeld and Dr. Karpecki, always great to see what you're experiencing in your patients. Also just reminds me how visual this disease is for the doctor in diagnosing it and also for the patient, seeing redness, understanding they have mites and we believe those are 2 real keys for us in further developing awareness for this condition. So now that in cleanup is Dr. Elizabeth Yeu. And Dr. Yeu is just a remarkable doctor and partner to Tarsus. She currently practices at Virginia Eye Consultants, where she specializes in cataract and refractive surgery as well as corneal and ocular surface disease. Dr. Yeu is an executive committee member and the current Secretary for the American Society of Cataract and Refractive Surgery, ASCRS, and in 2023, she will become ASCRS President. She is a recognized leader and influential physician and educator in the eye care industry. She has authored hundreds of articles and is a frequent lecturer nationally and internationally. We at Tarsus count on Liz as a trusted voice in eye care in so many ways, and we're grateful to have Liz serve as our Chief Medical Adviser, and also recently be appointed as a member of our Board of Directors. From the first conversation that I'll never forget Liz over just 2 years ago. So I'll pass to Liz to cover TP-03 and the Saturn-1 clinical data.

Thank you so much, Bobby. And -- thank you, Dr. Karpecki, Dr. Donnenfeld. There have been several common themes that have been carried here demonstrating the lack of current effective management options, and there's no standardization, unfortunately, for Demodex blepharitis. The clinical patient anecdotes that you already heard of presented by Dr. Karpecki and Donnenfeld represent the truest perspective of what we see clinically on a daily basis. First of all, Demodex blepharitis is extremely common, and I see it in upwards of 80% of my clinic day. And number two, this disease is quite burdensome. It creates repeated visits to the eye care provider. And there is a negative self-awareness that often accompanies the redness and the other patient symptoms that they experience. And this is not dry eye disease. It is a lid margin disease that affects the ocular surface, which also represents why dry eye disease management is ineffective in managing patients with Demodex blepharitis. Lotilaner comes to us from veterinary medicine. It is the most specific isoxazoline that is available, which makes it extremely important in paralyzing and causing death of only invertebrates such as pigs and Demodex mites. TP-03 or topical lotilaner 0.25% solution is a highly lipophilic solution. During the 43-day study, only this transparent drop could be applied twice daily without any additional wiping or mechanical scrubbing of the eyes. Next slide, please. The efficacy endpoints measured were collarette cure mite eradication or live redness of improvement. And as you can see here, all endpoints were met with very high statistical significance, as demonstrated by the multiple zeros that you see to the right of the decimal point. This was done with an excellent safety profile, which was similar to vehicle alone. Next slide, please. The regulatory required endpoint of complete collarettes cure meaning 0 to 2 total collarettes across the upper lash margin was achieved in 44% of patients. Of note, this statistical difference was observed by as early as day 15. The baseline entrance collarettes grade was about a 3, meaning that all patients within the study had an average of 100 collarettes starting a baseline of the study. Next slide, please. Just as important or potentially more important to clinician scientists is the clinically meaningful collarette cure, which is defined as 10 or fewer collarettes. This is the commonly utilized threshold in past Demodex blepharitis literature as the thresholds to cross or truly clinical important improvement leading to a healthy eye lid. As you can see, this endpoint was observed in as early as week 1 in almost 1/4 of the patients. The statistical significance was carried on for each time point observed in the study with an impressive 81% achieving this endpoint by day 43. Next slide, please. Regarding mite eradication the baseline mite count was an average of 3 mites per lash. By day 43, 68% of patients experienced complete mite eradication. 1/3 of patients experienced complete mite eradication by week 2 of the study. Next slide, please. Efficacy profile presented in the slides before, is very impressive, but I also find the overall responder rates to be very promising for both collarette cure and significant reduction of mites to a clinically non-pathologic level. As you can see, the response of Demodex blepharitis to TP-03 is well represented in these 2 sets of rats, where over 92% of patients had at least 1 grade of collarettes reduction and a very significant mite elimination to a widely accepted low and less pathologic level over the 43-day course of the study. Next slide, please. Redness or clinically understood as erythema, as we all know from other eye disease studies is a tricky endpoint to me because it is a byproduct of inflammation. One in 5 patients experienced complete redness resolution over the course of the study, and this was achieved with high statistical significance. 45% or close to half of the patients experienced at least 1 grade of redness improvement over the course of the study as well. This further demonstrates to me as a clinician that Demodex mites and their pathologic activity leads to inflammation. And that lotilaner alone without the use of an anti-inflammatory can resolve that said inflammation. Next slide, please. This slide actually demonstrates the 4 and after images of lids taken directly from the Saturn-1 study eyes. The baseline collarettes and lid redness are observed across the top row and the collarette cure rates and redness improvement are represented in the bottom. It is clearly evident that a minimal to few collarettes across the lash margin are very similar between Grade 2, which is less than a total of 2 collarettes or grade 1, which is 3 to 10 collarettes. And then last slide. Regarding the adverse event profile, only discomfort upon drop installation was seen in more than 5% of all patients, and this was only mild in both groups. Very importantly, a majority or 92% of the patients found TP-03 to be neutral to very comfortable as a drop. Lastly, TP-03 also demonstrated an overall excellent safety profile without any compromise to vision or toxicity to corneal health.

Thank you very much, Liz. So I want to open the line soon for questions, but let me summarize and also point to a couple of things ahead for Tarsus. So what we heard today is Demodex blepharitis is really common, 25 million patients in the U.S., 7 million in already diagnosed patient segments in eye care providers clinics, and there are no approved drug treatments. He is diagnosing Demodex blepharitis with collarettes and it just requires patients to look down slightly, as we heard from Dr. Karpecki, and this has implications not only in blepharitis but also, as we heard from Dr. Donnenfeld dry eye cataract surgery and clearly in ophthalmology and optometry practices. Demodex blepharitis matters, with 80% of patients experienced an impact on the daily life, often being seen multiple times across multiple clinics and not getting released. And some patients, as we saw in some of the really memorable slides have advanced complications since this is a chronic and progressive disease. So hearing perspectives like we have today, how impactful Demodex blepharitis is to eye-care patients are really key motivators for us at Tarsus and keep us and our team keenly focused on bringing TP-03 to market. So what's next for Tarsus? Well, first off is the Saturn-2, Phase III trial. The take-home message here is, this is a very similar design to Saturn-1. So we expect similar results. We're proud and thankful to have completed enrollment in a really challenging environment due to COVID, which speaks to the urgent need the treatment for Demodex blepharitis. And you'll see we finished with 412 patients. We had a very strong finish and we're able to enroll several patients in the very last phase of the study. We believe the primary endpoint of a strict collarette cure, if met here, will satisfy the requirements for FDA approval. And we also hope to show complete resolution again of the signs of Demodex blepharitis mites and eyelid redness. Also, we're always careful and creative about how we finance Tarsus. Our goals are to broaden our range of investors, strengthen our cash position further and give ourselves options to finance our launch and pipeline is the most attractive capital possible. Some of you will recall that last year, we struck a pioneering deal in China to bring in nondilutive funds and we view this deal illustrated on this slide as another very favorable capital mechanism as our Phase III trial completes and 1 that is not often obtained by companies at our stage. So this credit facility with Hercules and Silicon Valley Bank provides a significant amount of capital up to $175 million to extend our runway well into commercialization of TP-03. It also allows us to control and stage our draws, and provides these funds non-dilutively. So I'll end with a snapshot of 2022. This is primed to be a year of incredible growth at Tarsus. As you can see on the top, we're advancing TP-03 for Demodex blepharitis through NDA submission. We're also advancing our pipeline, as shown in the middle, to clinical proof of concept in Meibomian gland dysfunction, rosacea and lyme prophylaxis, other conditions where our highly effective and safe antiparasitic molecule to make a difference. We also are focused on expanding investor interest, expanding our world-class team and we've characterized our team by blending leadership from both eye care and biotech. And we announced this week our Chief Medical Officer, who comes from biotech, for example, and also making a transition to becoming a commercial company. So we thank all of you for your time. We especially thank Eric, Paul and Liz and all of the other eye care physicians that have shared their feedback and growing excitement with us. And most importantly, we thank the investigators and patients that are taking part in all of our studies. So with that, I'll turn back to the operator for questions from the analysts, which I will direct.

[Operator Instructions] Our first question comes from Jason Gerberry with Bank of America.

My first question is just trying to think about the sort of extensive market building that's going to be required to establish Demodex blepharitis as a therapeutic market in dry eye disease is often talked about as an analog here. So I'm curious if some of the physicians on the phone could speak to sort of the degree to which bother some symptoms drive the diagnosis for Demodex blepharitis, how that compares to dry eye disease or with Demodex blepharitis, our physician is really going to need to be searching this out with the slit lamp test. And along those lines, if the symptoms with Demodex blepharitis are truly bothersome to a high degree wouldn't it be easy enough to capture this benefit in the patient reported outcome on symptoms? And how important would it be to have some PRO data? And then my last question is just if you can speak to willingness to retreat with TP-03 and the importance of data on endothelial cell count as a measure of corneal health post treatment. Just wondering what you might look at specifically when the detailed data are made available?

Yes. Great questions, Jason, as always. So let me triage these to Eric, and then Paul, and let me just tee it up. So I think you're right, this is a market building exercise, but we think this is as attractive as it comes in eye care. And dry eye is a great analog. So I think Dr. Donnenfeld will be able to speak to that and what he sees as the opportunities. You mentioned symptoms and no doubt these do drive patients into the clinic, but notably, we don't have to hit those patient reported outcomes for FDA approval. So we've kept our path very simple. Moreover, we talk a lot with our advisers about what might compel them to treat patients. And what we see is collarettes plus redness should do it because redness is something the patients notice. And so I'll just briefly address the willingness to repeat, we are preparing a package that will allow basically chronic intermittent treatment from a safety perspective with the FDA. So with that, Eric, and then Paul, could you please address Jason's questions.

Sure, Bobby. Those are great questions and the question that I think any 1 would be asking at this time. And my response to that is, number 1 is the low-hanging fruit on patients who are going to be looking for lotilaner is patients who have failed previous dry eye ocular surface disease therapies. There are literally millions of patients who have tried Restasis, Xiidra, who have failed it and have stopped using it. The average life span of the patient who's put on these drugs is 1.5 prescription refills. I strongly believe that the reason why patients have not responded to the therapy or stop the therapies that we've been treating the wrong disease for a decade now. So that I'm going to believe that there are almost every clinician out there who is managing dry eye right now is looking for a better therapy to manage this chronic disease. What makes lotilaner exciting is that it has a completely different mechanism of action of anything else that's out there right now. Almost drifting that's out there right now is an anti-inflammatory. The 4 different Cyclosporine analogs, Eysuvis, Xiidra or all anti-inflammatory. This works in a completely novel way. Not only will be primary therapy for a lot of patients, but will also be ancillary therapies to a lot of patients who are already out there using medications. So there will be education that's involved in the launch of this new Tarsus product, and we will have to educate our optometric and ophthalmic partners about the importance of looking at collarettes about the symptom of itching. So there'll be education that's involved, but it's a very simple education process. It's something that's easily recognizable, patients will respond quickly, and there's nothing more rewarding to a clinician than treating a disease that has been ineffectually treated in the past and those create converts to therapy that will fastly pace other doctors moving forward. So I think the landing strip is pretty clear here, for what Tarsus has to do, and that is to get the drug out there, let people use it, teach them about the importance of itching and collarettes. But I think that it's going to be a very successful launch. And I'm very impressed by the leadership team that I've seen here at Tarsus, Bobby and the whole team, Aziz, Melissa and Liz, are doing an amazing job, and I think they'll launch this very effectively. I personally think that this is going to be 1 of the more interesting launches that I've seen in ophthalmology and optometry over the last decade.

I mean Eric really answered that beautifully. I'm going to emphasize a few things he said to just tie that in. So my clinic is referral only. And -- the reason for that is we just were -- my schedule is getting backed up 4 or 5 months, and we thought 1 way to make it work a little better on need to take referred in patients from optometrist, ophthalmologist, rheumatologists, that sort of thing. So it's 100% referral-based. And just even this morning, to his point, I would say half the patients referred with the diagnosis of dry eye didn't have dry eye, they had Demodex blepharitis. So it is a common reason for nontreatable or patients who have been on other agents that have not seen resolution of their condition. I think that's going to be the largest group. I think though there is also going to be a very large -- I don't know which 1 is going to be larger. There going to be a large group that's symptom driven, which is what made your question is so good, that's kind of how you were to it. Patients who come in and say, I have itching, I have irritation, I have redness -- and doctors think of itching with allergy. They think of other conditions. And so many times that driven is actually Demadex. And knowing how easy it is to make the diagnosis is going to uncover so many more of those symptom-driven patients. And then the last, I think not only are those 2 huge numbers. The third is going to be the patient population where doctors get in the habit of just looking at the -- scanning the lid margin, it takes literally less than 2 seconds, have then looked down, scan across. And with that, they're going to pick up all kinds of patients. And I think they're going to treat that last group, whether they have mild symptoms or not because of the risk of progression of this pathogen based on what we understand in terms of the course of it, that it could get into my boning lands and cause severe chronic dry eye. It could cause lashes to thin and fall out, which no 1 likes. It could cause that scalloped eye lid margin in the case of the patient we showed earlier. There's so many reasons to treat a condition that could damage tissue and the eye lids and the patient's quality of life that we're going to be treating those that we diagnose. So I think it is all 3. I agree, it's going to be those previously untreatable or misdiagnosed patients that we thought were dry eye is going to be those symptomatically driven, and it's going to be those that are picked up like the Titan study showed 58% of all comers had collarettes that we treat rather than waiting for progression damage and significant symptoms.

Our next question comes from Frank Pinal with Jefferies.

I hope everyone is doing well. So I guess first for me on prevalence, broader view. What percentage of your patients do you currently write prescriptions for per week, I guess, as a mix for blepharitis or Demodex blepharitis, how is that trending? And -- what do you think is driving increasing prevalence rates.

Thank you, Frank. So obviously, Demodex blepharitis is being diagnosed, but it's not really being treated. There's really only over-the-counter therapy. So -- just to clarify your question, are you thinking about any prescriptions such as dry eye or other medications for patients with Demodex blepharitis?

I'm basically asking really Demodex blepharitis and a that and then sort of where that trends on the broader sort of prevalence pool of blepharitis? And how is that trending? And what sort of the underlying -- what's the underlying cause here? What's driving higher, I guess, rates?

Got it. Okay. Why don't we do a quick round of answers there, starting with Dr. Yeu and then going to Paul and Eric.

It's actually great question. Similar to dry eye as being an analog, it's not necessarily that the prevalence is truly increasing. What we're recognizing is the uncovery of the information based on our own clinical identification and going into the literature. So 80% of Demodex blepharitis literature has actually been performed and done in the last 5 years, which all started with recognizing the importance of what's going on with external disease. So I am taking care of about 70% of my patients are being attempt management of their Demodex blepharitis because I am getting them ready for cataract surgery. With that, I'll turn it over to Paul.

Yes. I think Dr. Yeu covered that beautifully. And it is a very important question. I believe the reason we are seeing slightly more patients and I agree with Dr. Yeu. I don't think it's that there are more developing. I think this is just such a significantly common condition that we didn't -- doctors didn't know what to look for. And we're treating it with what they could. And we don't have a really -- I mean, as I mentioned, the treatments now are partially effective at best. There's not a lot of options that work for these patients. But yes, we're doing more in-office treatments than we've ever done before, where we use a device to clear off the lashes. The problem is it doesn't eradicate the pathogen Demodex. It debulks it. That's a good way of putting it, and it knocks it kind of out there and then the patient gets by a little bit longer with some scrubs to kind of manifest. But then 2 months later, three months at best or back again. And they're frustrated by that. But I educate them, I say, we don't have a good agent to treat this. We have ways to kind of maybe knock it off and then kind of slow it down a little perhaps, but expect that within a couple of months that you're going to be back. And if a patient go 3 months, they're excited because it's a month more. But the point is that we're seeing so much more of it. And I think the reason why it's not that there's more of it, it's just the easy diagnosis of it and the prevalence. The fact that when you start looking for it, you're amazed at how much is there. It applies to the cataract patients, Dr. Yeu described, and Dr. Donnenfeld, it fills a great case. It applies to dry eye patients, which Dr. Donnenfeld described especially. And if you think about evaporative dry eye, the most common form of dry eye. The only time I really started getting success with this form of dry eye wasn't when we just treated the inflammation because that's a byproduct of the cost. It wasn't treating the tear film because that's a byproduct of the cause. It was only when we started treating as best we could to bulking this top of the eye lids, treating the obstructed glands, that we started to see some success. But until we could truly eradicate this pathogen, we're not going to have long-term success. We're getting this temporary effect, but it just emphasizes how important that blepharitis component, specifically Demodex is in the course of dry eye development as well, but the focus being on treating the blepharitis so you don't have that inflammation. And I think that's the key because Dr. Yeu showed beautifully how you could decrease redness, which is a sign of inflammation by getting rid of the pathology, the Demodex that causes it. You don't need a separate anti-inflammatory agent when you treat the cost, I think that's going to be key to the future. And we're going to -- as doctor started looking for this as easy it is to find it. I think we're going to see incredibly significant trends of growth diagnosis of this condition, but maybe it's already been there just hidden in plain sight.

Great. Just a quick follow-up, if I may. I guess outside of...

If I could just...

Oh, please, yes, go ahead.

A little bit of a different perspective on that. And that is very simply that for decades, always had immunomodulators for aqueous deficient dry eye. And whenever you -- when you only have a hammer, everything looks like a nail. So for a decade or 2 now, every form of ocular surface disease has been assumed to be aqueous deficient dry eye, which is completely wrong. Over 2/3 of dry eye is due to blepharitis and the Meibomian gland dysfunction. Now that we have another pool of toolbox other than a hammer, we're going to start looking for other diseases to manage the disease, to manage ocular surface disease. And once we understand the significance of Demodex you're going to see a huge swing towards therapy directed to managing Demodex. In the past, we don't have a therapy for Demodex. We didn't have anything to work for these patients, so we just didn't look for it. Now we're going to start looking for it because we understand the importance and we'll have a therapy.

Just I have time here for a follow-up. That would be great. I guess outside of what seems to be a pending regulatory approval once the Saturn-2 study is in. And I guess, obviously, patients getting insurance coverage, getting the approval from the CMS and other payers. Do you see any significant barriers to adoption from a patient/doctor standpoint? And how sort of easy or difficult would it be to educate patients on TP-03. We'll take a few conversations with the doctor will a direct-to-consumer campaign be effective in your view?

Yes. Great question. So why don't I have Liz cover that? I'll just say that we are certainly actively thinking about direct-to-patient and the broad education. And we are really working in advance on reimbursement as well. But from the doctor's perspective, Liz, what do you think it's going to take to spread awareness here?

That really is -- that's a hugely important part of the pre-commercialization piece. And what we are so fortunate is that there is a direct connection between what we see being the collarettes having just that slight adjustment, which is having patients go down, that is part of the normal examination of the lid, but the lid has been overlooked. We only started looking for Meibomian gland dysfunction at the lower lid in the last 5 years. Similarly, at education, plus recognizing that truly this is actually part of multiple protocols including the chief of twos as being second-level therapy for any ocular surface disease. For ASCRS and the clinical committee, the #1 rule of doing a good external exam is LLPP. The first part being, look, we just have to teach our doctors to look down. And that patient conversation we will have our expert doctors who are kind of very used to taking care of trying to manage Demodex blepharitis and finding that fine line between encouraging patients to get the treatment versus staring the patients about the idea of "mites". So there is that fine conversation of kind of broadening how we do message this to want to encourage our doctors as well as our patients to treat Demodex blepharitis as bugs that overgrow and can create symptoms as well as redness and doing our best to potentially eradicate this with TP-03.

Thank you, Liz. And I know we're a little over time, I want to make sure we get a couple more questions in. So operator, next question.

Our next question comes from Francois Brisebois with Oppenheimer.

Just a quick 1 here that might be a little different. Is there -- are there any physicians out there that might think that there's a reason that we need Demodex. And so eliminating them and doing a mite eradication might lead to issues.

Yes. So Eric, you spoke so eloquently about your knowledge there. Why don't you take that one?

Yes. We've published extensively. My partner Hank Perry might be the world's expert in Demodex. And the answer to your question is, no. Do you want me to pontificate on that a little bit more. I'd be very happy to. But in the past, there was an affiliate Demodex was a conventional organism. This has been totally refuted. The Saturn studies just show the effective Demodex. And if you understand the life cycle of Demodex and how Demodex causes inflammation, there is nothing comment about it. And I think that a little education is always needed. I think people don't really think about Demodex for the most part. They don't understand it. They don't think about it. They don't look for, but I don't think there'll be any issue with doctors believing that Demodex is something that we need to have.

Okay. Great. And then just lastly, on the -- in terms of the prevalence, you talked about the 25 million patients out there. Are they -- I think in the study, the baseline was Grade 3 for collarettes, is that where most patients are? Is it grade 3? Or I guess how -- we talked about how easy it is to see the collarettes, but is it easy to see when it's just a grade 1?

Liz, why don't you take that, please?

Spanning the upper lid margin is going to be key and if you just have the patients look down, the expresses are very, very easy to see at the lash base. Even a single collarette is easy to notice as long as we are actually scanning across the lid margin. I will say that an average of grade 1 to 2 is extremely common. But I see grade 4 in patients as young as 20 years old because they're coming in for Lasik evaluation, and they are concurrent contact lens users who are intolerant of contact lenses. So I definitely do see the expands of the different grades, but every grade level is easy to recognize if we just have the patients look down.

And Paul, in your clinic and your optometry clinics, any perspective that different?

I think Donnenfeld, you covered that beautifully. It is very easy to pick up. That's why there's that home moment the first time a doctor has a patient like down and they see it because it's just, wow, how could that have been so obvious. We've never been taught to just look that way. We look straight on, and you can't see it with the lash is culling around it. It's just no way to see it or even if they're straight. So I agree. I think that the majority of patients are going to be -- I mean, the ones that we are typically seeing in maybe grade 3 because they're so obvious. But when you do the simple test of looking down, all of a sudden Grade 1 is obvious. And even trace is obvious. And I think there are going to be many doctors like myself who recognize that any presence of this, to Eric's point, needs to be treated immediately. I don't want this progressing to where we'll take care of it when you lose all your lashes or they thin out or you've got evaporative dry eye because now it's in the Meibomian gland. So I think that the good thing is it's an easy diagnosis. The second thing is you pick up early stages because it's so easily diagnosed. And the third thing is, why wouldn't you trade it right away to prevent some of the sequela, we talked alone about let alone the quality of life effects over time.

Excellent. So 1 last question, please.

Our last question comes from Patrick Dolezal with LifeSci Capital.

This is Cory on for Patrick. So just a couple for the KOLs. First off, how cost sensitive are your patients given the availability of over-the-counter tea tree oil? And on that note, what out-of-pocket price point do you think the average patient would reasonably tolerate for a course of treatment? And do you think the genericization of the dry market will impact TP-03 adoption?

Great questions. Yes, we're going to certainly prioritize patient access here. But why don't we take Paul and then Eric, given the optometry/ophthalmology perspective.

Sure. Thank you. It is an excellent question. As all of them have been, I'm impressed with all the questions we've had. So first of all, I think the price point is going to be quite -- while I agree with Dr. Elizabeth and Bobby, you want to be able to make access a key. I think these patients suffer so much that I think they're willing to do whatever it takes. And I can tell you that because we do an in-office blood for exfoliation. Our typical price is close to 200. These patients are coming in every 2 to 3 months to get this done. There's a lot of price, one, plus they're using products in between to try and get this controlled plus we're adding in anti-inflammatories, plus we may be treating a little bit of the oil glands to kind of help. So all of these things are in there. And yet they don't miss their visits. They're back because of that. They don't like the feeling of it. They don't like having these microorganisms that are present. They don't like how their lashes of thin compared to what they used to be. My patients, I'll describe, I remember when I had these beautiful long lashes I had 2 patients this morning, say exactly that. And so it is a -- they're willing to do what's necessary for this, and it's evident by the fact that they're signing up for these in-office procedures, none of them are covered by insurance. They're the best we have right now. And they at least debulk it for a period of time. I don't think that the going to the generic cyclosporine that are going to change that dry market are going to have a lot of effect because these are different pathology. Now there's going to be many dry eye patients that had Demodex that didn't have -- they get some mild evaporative dry eye that may be a part of it because of the Demodex maybe affecting the glands, but they're not -- they've had the wrong diagnosis, the real cause of everything that's developed is Demodex. And so no generic form of cyclosporine has helped them -- no form of cyclosporine has helped them to date nor is any of these immunomodulators or inflammatory because of the cause was actually Demadex. And I see that frequently, as I'm sure Dr. Donnenfeld and Dr. Yeu do as well. And so for that reason, by treating the actual cause, you're going at what's necessary, and that will not be affected by a cyclosporine, whether it's branded or generic in any way. So I like the idea of making it accessible to patients for the benefit of my patients, in particular and everyone that needs this. But I also know that these patients, because of the effects on quality of life on chronic dry eye potential on how their eyelids look and lashes look, they're very motivated to the point. We're seeing that evidently by our procedures. And I think that a generic dry eye product is not necessarily therapeutic the cause here. And if we look at the cause, people are still going to need lotilaner should it get approved as the cause of the treatment rather than some downstream dry eye that may have resulted.

Yes. I'll just follow up by saying the success of our new drugs in the market is dictated by the effective of the drug, the side effects associated with the drug and the cost of the drug, and they all play a significant role in the success of a medication. I think the effectiveness here speaks for itself. We haven't really spoken about the side effects, and that's another major advantage of 1 liner, is that, it's very well tolerated, much better tolerated than immunomodulator, Cyclosporine and Xiidra. All have significant burning and irritation. This is an extremely well-tolerated medication. Now what will patients pay out a profit for this as Dr. Karpecki mentioned, it depends upon the severity of disease. We all know from experience that insurance coverage is really important to the success of a drug. And -- there are always going to be trials in the beginning of a new drug that meets the market and it takes time for insurance plans to adopt the new medication. But the advantage here of lotilaner, there's no generic equivalent. There's nothing even close. And if you want -- and I would have been considered tea tree oil to be a consideration here. It's not even close to as effective and it has many more side effects. So you're really dealing with first-in-class, only-in-class drug for managing a chronic disease, which is important to patients. So I see adoption as being very successful. But I think the insurance part of it will take some time and Bobby and the team know that. We've all looked through that in the past, but we'll all get through it together.

Very well said and helpful. And I'll just add as a reminder that this is not a chronic therapy. This is a rapid, complete and durable therapy as our Chief Commercial Officer, Aziz Mottiwala, likes to say, and that should have great benefit also from a payer perspective because it's not taking this monthly [ ad nosium ]. It's taking you once or twice a year. So -- thank you, and I'll pass back to the operator.

Thank you. At this time, I'd like to turn the call back over to Bobby for any closing remarks.

What a great first Tarsus webinar for the entire audience. I've really enjoyed it. I thank Dr. Donnenfeld, Dr. Karpecki, Dr. Yeu, and as we look forward to April and our Saturn-2 top line, we look forward to engaging with many folks on this call further. So thank you for your time this morning.

This concludes the program. You may now disconnect. Everyone, have a great day.