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

Good morning, and welcome to Tarsus' commercial webcast, where we plan to provide an overview of our strategy, plan and progress to bring TP-03 for Demodex Blepharitis to market and achieve commercial success. Before we begin, I encourage everyone who has not launched the webcast to proceed to the Investors & News section of our website to find the link to this webcast and the related slides. As a reminder, this webcast is being recorded and a replay will be available on the Investors & News section of the Tarsus' website later today. We have 1 Q&A session at the end of today's program, and to ask a question, please submit your questions in the question-and-answers chat box and then click send. Today's slides may also be downloaded from the Presentations section of our website or directly from the webcast. For technical assistance, click on the help icon. I would like to draw your attention to Slide 3, 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 me on today's webcast are Bobby Azamian, our Chief Executive Officer and Chairman. Providing their perspectives on prevalence, impact and diagnosis of Demodex Blepharitis, I'm excited to introduce 2 leading KOLs; Dr. Selina McGee and Dr. Marjan Farid. Dr. McGee is the visionary founder of BeSpoke Vision, specializing in dry eye disease, specialty contact lenses and aesthetics. She is also the Co-Founder of Precision Vision of Midwest City, an MD-OD practice specializing in premium intraocular lenses and cataract surgery, and Vice President of Intrepid Eye Society, an emerging group of OD thought leaders committed to advancing innovation and promoting growth and excellence in optometry. Our second KOL is Dr. Farid, Professor of Clinical Ophthalmology, Director of Cornea, Refractive and Cataract Surgery, Vice Chair of ophthalmic faculty at the Gavin Herbert Eye Institute, University of California at Irvine. Her clinical practice is divided between patient care, teaching and research, which is focused on corneal surgery. Dr. Farid serves as a Board member on SightLife eye bank, serves as the Chair of the Corneal Clinic Committee of ASCRS and the Program Chair for the EBAA. Sharing our commercial plans as we prepare to launch the next frontier in eye care, we have Aziz Mottiwala, our Chief Commercial Officer; and Neera Clase, Vice President, Market Access. Joining us during the Q&A session is Jeff Farrow, our Chief Financial and Strategy Officer. And with that, I'll turn the webcast over to Bobby, our CEO and Chairman.

Thank you, Dave. I'm Bobby Azamian, the Co-Founder, CEO and Chairman of Tarsus Pharmaceuticals, and it's my pleasure to be with you here today. And this is a really pivotal moment for me and for our company. Personally, this is so gratifying because we can finally get our drug to millions of patients. We are now a commercial company. I've been working at this for a number of years. I'm so pleased with how the progress has gone. But when I take a step back, what does this mean? Well, I started out in this business because I really wanted to serve the most patients I could, the most profoundly that I could. And it really involved getting to the root causes of things. I was a physical scientist first. And then it involved addressing the biggest chronic disease that was unserved or underserved that I could. And now, with TP-03 on the cusp of launch, with the team that you'll meet today, I think you'll see that we are now ready to serve millions and create the next blockbuster eye care drug. We've done things differently. We value diversity at Tarsus, and we'll continue to do things differently because we need to. We're creating a new category, and we're doing that with a curative product. Two things that really haven't been seen in eye care in a long time. I know our launch will be successful because we have 2 rare advantages. We have a large damaging disease in Demodex Blepharitis that represents a multi-billion dollar new underserved category and TP-03 will be the very first drug. Beyond being first, it has very strong outcomes, and that yields to value and pricing at a premium, as you'll hear today. So, we understand deeply how to launch this drug. And one of the things I'm proudest and most grateful for is our team. We have special leaders with special skills, and they blend the best in biotech with the best in eye care. That blend, as you'll see, is going to be essential for launching our drug. Beyond our launch, we are on a path to becoming the next eye care pharma leader. We have a very unique platform to build around, and we're already working on that. As we launch blockbuster 1, TP-03, we're already working on blockbuster 2 through our pipeline and through the opportunity we see in this space. So let's talk about our eyes. We all know how important our eyes are. What's not often that well known is that the front of our eyes is the bigger opportunity because that's where some of the most common diseases are found. And if you look at the blockbusters in eye care, they're, firstly, created with new categories like TP-03 will create. And secondly, most of these actually have been to address diseases of the front of the eye. And you can go back to the first Prostaglandin in glaucoma, obviously the first dry eye drug where we see a lot of parallels and a lot of opportunities even beyond. And also, more recently, the first thyroid eye disease drug. So, the eyelids are the next frontier in eye care, and we are charting that course. There's never been a blockbuster for the eyelids until now. And the reasons are there's an extremely large need with eyelid diseases, and it's extremely pressing. So, we understand this launch, we're also ready to launch this drug. We've seen that patients, doctors and payers, all the key stakeholders, are aware of this category and eager for our medicine. And that's because, I'm proud to say, we've taken a very high-touch engagement, focused really on the essence of the drug, which is the value that it delivers. You'll hear more about that today. We've educated all the target eye care providers with disease education and on all clinician medical team, eye doctors educating eye doctors. We have a targeted sales force that will address over 80% of all the prescribers, and we have broad payer engagement, and you'll hear more about that today. Because this disease affects millions of patients, we need to broadly engage the payers, And now is the time to learn more. There's a lot of value to be created here in the near term. By the end of this year, we'll have the first full quarter of prescriptions under our belt. So let's talk about Demodex Blepharitis. When you take a step back and say, what is this disease? It's very simply mange of our eyelids. Think about that. Animals have mange, and it's mostly caused by mites. Our eyelids get an infestation of mites. So Blepharitis isn't new. Companies, clinicians, we've known about this disease for decades. The burden's been very long appreciated, inflammation, redness, irritation, a negative impact every day for patients. Only recently, however, has the root cause of the majority of Blepharitis been described, and that's Demodex mites. We also have a tremendous advantage with this disease. Sure, it's really gross to look at lashes under the microscope and see mites squirming around, but we have an easier diagnosis, a beacon, if you will, in a collarette that's the image shown on the left. So instead of looking under the microscope, doctors can easily and quickly diagnose patients by simply having them look down and looking at the base of their eyelashes. And this is a very visual disease. So, think about what we've all experienced going to an eye care doctor. The first thing they do is they have us put our chin in that slit-lamp microscope. And what does that allow? Well, that allows the doctor to look at our eyes and look at them under illumination and magnification. And you can easily see a red eyelid, but it just takes having a patient look down to look at the margin of the eyelid and see collarettes, and that belies real disease under the surface. It gets even grosser. When you look at the surface of the eyelashes, you see these collarettes. They're composed of dead mites of debris, and that really represents pathology underneath the surface. As you dig deeper, you see eyelashes crowded with mites. Half a dozen, dozen are not unusual. And that causes real disease, inflammation by mechanical obstruction, by chemical irritation, by bacterial translocation. And all this can be diagnosed very easily and simply within seconds, by simply looking for collarettes. That allows us to unlock an immediate opportunity. We believe TP-03 will be a $1 billion peak product in a new multi-billion dollar market category. And that's because there are waves of patients already seeking care from their eye doctor that we will serve with TP-03. We talked about it. Over 25 million in the U.S., but over 7 million of these patients actively seeking treatments and really low-hanging fruit, really high unmet need of 1.5 million already diagnosed patients with Blepharitis that have Demodex and collarettes. We see opportunity that's immediate beyond that. 1.2 million dry patients who, in fact, have collarettes and likely need a different prescription. So even a fraction of this market creates a blockbuster, as you'll hear more later today. So, the time is now, we finally have this incredible product ready for the market in TP-03. And let's talk about the product. From the start, we wanted a convenient and easy-to-use product, and we have that in an eye drop, used twice a day for 6 weeks. We've seen, in multiple trials, 2 large pivotal trials in fact, the majority of patients cured of their disease, their collarettes, their mites, even their redness, which is really hard to do with any eye drop because it shows that we're curing inflammation. Beyond those cures in half or more patients, we're seeing that nearly every patient responds. So a doctor knows when they treat a patient with TP-03, they're going to see a clinically meaningful response, and we see those responses and cures to be durable, lasting 6 months, and we do see some recurrence, which is natural for this disease by 1 year. So, in short, these strong outcomes lead to strong economics. You'll hear more about that, the value this drug confers for patients, doctors and payers. And we're so motivated to get this drug out there. We will have it in doctor's hands within weeks of approval, and we intend to create a standard of care that will last for a very long time to come. So, can't wait for you to hear more from our team. First, with 2 very compelling doctors, with very compelling stories. I met both of these doctors in the last couple of years and I'll never forget meeting them. Dr. Selina McGee, a college athlete now at the cutting edge of medical optometry, a leader in external ocular diseases. She'll talk about that, how she constructed her clinic to be able to serve the most patients with the most diseases and an entrepreneur in her own right, which I really admire and respect. And Dr. Marjan Farid, an immigrant who overcame adversity early in her life and has become one of the most sought-after corneal surgeons, a pioneer in corneal transplant surgery and also a leader in managing some of the most severe ocular surface diseases. So with that, Dr. McGee, it's my pleasure to pass to you.

Thank you, Bobby, for having me. I am excited to be here. I am Dr. Selina McGee, as Bobby said, and I am here to provide our physician perspective in prevalence, impact, and diagnosis of Demodex Blepharitis, along with Dr. Marjan Farid. I'm super excited to be here and talk about this, and I want to give you all just some background about me and why I am passionate about eye care and partnering with Tarsus and working towards helping a condition that we see all the time. But I want to give you a little bit of background about how I got here. So, I've been in practice for almost 22 years. I am an optometrist. I practice in Edmond, Oklahoma. And I am in private practice. I'm very active all across optometry. But why we're all here and why we want to share this with you is at the end of the day, it's really about helping my patients look and see their very best. So that's how I've gotten here. And with that, I am in private practice. This is my practice, bespoke vision. And a lot of my patients often ask, "How did you get to the word bespoke?" And so, I want to share that with you because you'll see a recurring theme as we talk here. And as you know or may not know, bespoke means customized, and that's exactly how we treat each and every one of our patients. We customize our solutions to the patient. It's not a cookie-cutter kind of practice. There is no number to the patient. We see each patient and want to expand and help them absolutely see and look their very best. So, I practice medical optometry. I have a very specific focus around dry eye and ocular surface conditions. We also treat corneal diseases that require custom and special contact lenses that traditionally patients have either not been able to wear contact lenses or they need a special contact lens to be able to achieve functional vision. And then several years ago, we actually added eye rejuvenation services, and that's going to be important too, as we have this conversation, because Demodex Blepharitis very much affects not only how patients feel, but also how much and how they look. So, let's talk about Demodex Blepharitis and what I experience every day with my patients. This has been a disease that has been prevalent for decades and it's been often overlooked because, honestly, we didn't have any good way to treat it, and we still don't. That's why we're so excited about TP-03. And many times, diseases that we are diagnosing a patient with, we have to go through several diagnostic tests, alongside medical history, alongside their clinical exam to ascertain what diagnosis the patient has. And what I'm excited about and happy to tell you is, Demodex Blepharitis is very easy to diagnose with one small change to your slit-lamp exam, which all of us in eye care have a slit-lamp. There's no extra diagnostic testing. All we have to do is simply have the patient look down and look for the presence of collarettes. So I have a couple of pictures pulled up here that I want you all to be able to see the way that I see behind the slit-lamp. And the picture on your left is the same patient as the picture on the right. But when you look at the patient and they're looking straight at you, you're not seeing a whole lot of their lid, and you're certainly not seeing the base of their lash. So with that one instruction of having the patient look down, and that's what we're seeing on the right picture. So looking there, we can uncover lots of things, but a very easy one, and I'm going to point out is collarettes. We know that the presence of collarettes is pathognomonic for Demodex Blepharitis. It that simple. And so, when you just do that 1 test, it takes about a thousandth of a second -- up to a second, to be able to do that. And you can see those collarettes. This patient also has some inflammation and redness and that's creeping towards all of those Demodex that have created inflammation along the eyelid margin, which is redness. And that's why this is important to me too, because, again, patients don't always understand that there's a correlation with this inflammatory process and their eyes being red. So, this is a very simple way to diagnose a very prevalent condition. And in fact, looking at the studies that Tarsus has ascertained around 25 million people in the U.S. have Demodex Blepharitis, because I see patients all day, I think it's actually higher. When I started looking for this a few years ago, because Tarsus has done such a good job around disease education and disease awareness. I look for this on every patient now. And what I noticed is, it is highly prevalent, and it can happen in children all the way up to my oldest patient, which is about 105. It does not have a preference for gender. It happens in males, females of all ages. And that's why it's so important for us to have a simple way to look for this, which is just having the patient look down. That is the prevalence of Demodex Blepharitis. But I also want to share some cases with you and really bring this to life of why this treatment with TP-03 is so important. So, my first case is a 42-year old female, and she came in with complaints of difficulty wearing her contact lenses. And for those of you that are watching right now, if you wear contact lenses, imagine not being able to wear them for as long as you like or not as comfortable or being able to wear them for years, and then all of a sudden, it seems like, gosh, I just can't seem to wear these the way that I want to. And she was very much frustrated by that, as you can imagine. And also frustrated with redness. I mean, when you look at that very prominent vessel and you see all of those collarettes on her lashes, you can imagine that she would have issues with redness. She also complained of itching, and patients will often describe my eyes itch, and they'll show you how they scratch their lashes. Burning and misdirected lashes, you'll see that on the picture. She's missing lashes. She was just really overall unhappy with the appearance of her eyes and how they felt. So, this is a patient that I see really every day. And currently, what I'm able to offer her is, in-office lid exfoliation. So, I'm able to do a procedure to remove that debris, and I'm also able to do a procedure called Intense Pulsed Light or short for IPL, and that will start to target those unnecessary blood vessels that you saw in her upper lid that are leaking more inflammation. I talked to her about doing lid hygiene at home, making sure she had the right type of cleanser, the right way to remove her eye makeup. And then, we also talked about specific ingredients in her eye makeup so that we didn't exacerbate the problem. She was asked to come back to our clinic in 4 weeks to follow up with another IPL treatment. So what you need to know about these treatments is it takes multiple treatments, and patients often are in our clinics at least 4 to 5 times a week or 2 apart. And then they have to have maintenance treatment about every 6, 8, 12 months, depending on their disease state and how well they respond to the treatment. When she came back, she saw some improvements in redness, but her contact lens wear was still limited. So, this is frustrating for me and the patient because there's no easy way to treat her. We're doing multiple things, and she still didn't get the desired result that she really wanted. So that's why I'm excited about TP-03, because now I will have a drop that I can give her on that very first visit. She's going to do it twice a day for 6 weeks, and then we're going to decide, do we need to move forward with any other treatment. And it's very different. I don't have that option right now. So that's why I'm excited about TP-03. That's the first case. Here is a second case. So this is a 60 year old male, and he was actually referred to me. So I have a -- as you learned, a large dry eye practice, so I often get referrals from other physicians. And he presented with eyes that burned, itched, watered. He had already been diagnosed with dry eye disease, and he was referred to our clinic for a further assessment because he hadn't really gotten where he wanted to be. If you look at this picture, again, you'll notice that we're very easily just having the patient look down, and we see those collarettes that are sheathing the base of his eyelashes, and you see eyelashes that are, again, growing in the wrong direction, and were missing lashes. This patient has undiagnosed Demodex Blepharitis. He had never heard of this, and it is easily missed and easily overlooked if we don't have those patients look down. So when we look at him, I did some additional testing to ascertain, does he really have dry eye disease or does he have Demodex Blepharitis that was misdiagnosed? And when we looked at his tear film osmolarity, which is basically the salt content of the tears, and also we look for an inflammatory marker, those were both normal. And that tells us that his ocular surface is actually fine. The problem is actually with his lids and the fact that he has Demodex Blepharitis. So, this patient was a bit frustrated in the fact that he had been misdiagnosed, and now he has a condition that I don't have a really good treatment for yet. And so, I did the best that we could with what we have today, which is basic home lid hygiene with a prescribed cleanser to help with the debulking of collarettes. He was asked to come back in 4 weeks. And what we often find with patients is, we're asking them to do a lot of things at home, and they often will be non-compliant with that. And this was a patient that responded in that way. He came back in 4 weeks. When we asked how he was doing with his lid cleanser, he's like, "Oh, I used it for a couple of days, and then I kind of got out of my routine and I forgot about it." And that is a story that gets told over and over in our clinics, and he was still complaining of eyes that didn't feel good; they itch, they burn, they water. And he's like, "Don't you think maybe this could be allergy? And -- so we go back through the education piece, no you have Demodex Blepharitis. The special part about this patient is, today, I don't have really a good way to treat him. But fast forward in a few months, I'm going to have TP-03 that I could have prescribed him the very first moment that I saw him. Again, twice a day for 6 weeks. And that's what's exciting about this. And the more disease education that we do, along with this, maybe that patient even doesn't get referred to me because he gets properly diagnosed before he ever came to my clinic and was treated in that way. And -- so that's why we're all here, and that's what's really exciting about TP-03. Our patient outcomes are going to be different. When we look at my last patient, this is a patient that presented, and in his words exactly, "I'm absolutely miserable." And the reason he is miserable is because over the last 18 months, he's had Chronic Chalazia. So that's something that you might have heard of as a Stye. If you've ever experienced that, they're painful, they're very cosmetically unappeasing and very frustrating for the patient. So this poor man has had this going on for 18 months, not just 1 or 2, like 2 or 3 bumps per eyelid at a time. So at any given moment, he's had 2 bumps on the upper lid of his right eye, left lower lid, just a constant Chalazia recurrence all over his eyelids. And we know, based on studies that Demodex Blepharitis leads to Chalazia. So, this is a patient that, at the moment, the only way that I can treat him is 3 ways. I can use a needle and put steroid in his eyelids to help with the redness and try to reduce the inflammation; I can actually do a blade and cut into his eyelid and remove some of that inflammatory tissue; or I can use a non-invasive approach, which is with light therapy, still not super pleasant for the patient because they have to do this about every week for 5 to 6 weeks to try to get control over this. And this was a patient that we had to do that with. So he opted not to have the blade or the needle, but have the light therapy. We did 5 to 6 treatments 1 week apart. And then for us to get him really stable where he wasn't suffering with this constantly, we did another treatment at 4 weeks, another treatment at 8 weeks, another one at 12, another one at 16, and we finally have gotten him where he hasn't had a Chalazia or Hordeola in the last 6 months. But as you can imagine, for this patient, this is very much affecting his quality of life. All of those doctors' appointments, his appearance and how he felt. When I have TP-03 and he comes into my clinic and says, "I am absolutely miserable." That's the first thing that I'm going to reach for. And now I will have a way to help patients who have experienced this. This is so important, and this treatment is going to change lives because I've given you 3 examples of patients who needed something more than what I was able to provide them. So that's why I'm excited. Hopefully, you'll have questions, and I will be around for questions and answers. I would, at this point, like to turn it over to Dr. Marjan Farid. She is an amazing ophthalmologist and I know you all will learn lots from her.

Thank you so much, Dr. McGee. My name is Marjan Farid. I'm from the University of California, Irvine, Gavin Herbert Eye Institute. I'm the Director of Cornea, Cataract & Refractive Surgery. And my practice really is a surgical practice, but it is a diverse surgical practice. I focus on corneal transplant surgery, cataract surgery and refractive surgery, such as LASIK, severe ocular surface disease. And I also manage the more severe refractive dry eye and lid margin disease as well. And as a surgeon and really focusing on surgical patients, Demodex Blepharitis is really of utmost importance because really it can impact surgical outcomes, both from patient satisfaction outcomes as well as safety because Demodex Blepharitis as a vector for bacteria can really harbor infectious pathogenic bacteria that can put surgical patients at risk for infections. So with that, I wanted to kind of go over a couple of cases where we see Demodex Blepharitis and its impact. So when it comes to Demodex Blepharitis specifically, all of these areas that I treat, Demodex Blepharitis impacts them pretty strongly. And we see this day-in and day-out, and we see it more and more now that we are really honing in on the pathology and pathophysiology of lid margin disease. And I think that area in dry eye disease management, ocular surface disease management, we're becoming more knowledgeable. The fund of evidence-based medicine is increasing in this area. And -- so we're really learning more than we used to know in the area of lid margin health. And so, as patients come in with problems, we're able to hone in a little bit better with better diagnostics and better education around diseases such as Demodex Blepharitis. So this is one of my very common patients. This is a 24-year-old young woman who is a contact lens wearer, a chronic contact lens wearer. She's just starting out her career as a software engineer, and she comes in really upset. She gets really chronic red eyes, irritated on the inability to wear her soft contact lenses for a period of time. And she gets these recurrent styes or chalazion we call it. This is an image -- a representative image. This is not an image of her eye specifically. But these chronic chalazion which are basically the oil glands and the lid margin getting clogged up. And many of us may have experienced a chalazion or a stye in our life, and we tell patients, put hot compresses on it and they go away. But in some patients, these are very recurrent, and they're very annoying, especially in a young woman. They can also be very cosmetically, a nuisance. So she's gone to her optometrist, who gives her, her contact lenses many times. They've tried switching her contact lens brand, but really to no avail, she's still suffering significantly. And -- so she comes in and sees me. Again, she is having difficulty working at her job, always feeling irritated and gritty and her eyelids are always red and irritated. And so we kind of do this deep dive now where we actually have patients. We're looking at their glands. We're having patients look down so we can appreciate the base of the lashes and we pick up a significant number of collarettes, and those are those greasy sleeves that we see at the base of the lashes that are really pathognomonic for Demodex Blepharitis. We also squeeze the oil glands to see the quality of the secretions that are coming from the oil glands, and those are clogged up as well. So we're not getting good, clean secretions of oils, and that goes to her inability to have a good tear film, a good oil layer, and why she's unable to maintain a good quality vision at the computer and long-term ability to wear her contact lenses. So, with this, we basically hone in on the fact that her underlying issue is Demodex Blepharitis. And Demodex Blepharitis really, not just the Demodex mites being an issue, but the fact that these are a vector for bacteria that can get into those Meibomian Glands and create long-term Meibomian Gland disease and stasis of the meibum or the oily secretions from the lids that then go on to produce or be a risk factor for recurrent chalazion. So, what do we do for her? We basically started doing these lid exfoliation treatments in the office, and this is a device with almost like a spinning -- almost like a toothbrush at the end of it. But it's non bristled. And it's fairly safe, but the procedure can only be done in the office because it can cause a corneal abrasion. It's not -- you can't do this at home. Don't try this at home. And -- so, we do this procedure on her, just to get the bulk of those collarettes cleaned up. So, we want to really decrease the burden of her mite load on her lids. We started her on-home tea tree oil lid scrubs, commercial formulations of these lid wipes. We started her on hot compresses to get the meibum moving a little bit, and then artificial tears as well to improve her dry eye -- secondary dry eye as well. So, she comes back. She does have some relief in symptoms because we've decreased the burden and the load of the Demodex mites. But still, she's not fully happy. She can't wear her contact lenses for more than a few hours. And she really has to come in every few months to get this exfoliation treatment done in the office, which is not ideal for a young person who wants to move on with her life, and compliance is a huge issue with young patients and all patients really, because they just -- they might start out doing these lid wipes and lid washes at home, but it really doesn't carry through long term. And these mites, as we know, regrow, and so it sort of becomes the cycle. And so -- she is very frustrated. Many of my patients are like this and in the same boat. Her work and her quality of life are significantly impacted as well, because she really can't go back into her contact lenses for any significant period of time. So this is one of my very common type of patients I see in the younger category. And then, on the older side and the side that really, for me, is very scary are my surgical patients. These are patients I want to do cataract surgery on or corneal transplant surgery on and who come in also with significant lid margin disease. And you can see this patient when he looks down, he is one of our cataract patients, significant collarettes on that upper lid margin, those greasy sleeves that harbor these mites that are vectors for bacteria, and these bacteria have toxins and can really increase the risk of surgical infections as well. So, for me, this is also an area where I really try to hone in and try to clear up as much of the bacterial and the mite load as possible before we get these patients into surgery. So, these are typical patients. They come in. They have red itchy eyes and usually, it's their eyelids that are itching. So, when we kind of hone in on where the itching is, it's usually in their eyelids and that's really a hallmark also of Demodex Blepharitis. But he just wants cataract surgery because he thinks that really it all comes down to the fact that it's his cataract that's causing all of these symptoms. So, really a lot of education is required in these patients to kind of, yes, you have a cataract, but actually, I can't do your cataract surgery yet because we have to improve your ocular surface disease. We have to improve your lid margin health in order to safely do cataract surgery on you. And a lot of our older patients don't want to buy this. They just want to get their surgery done and be done with it. But we really have to put the brakes on and initiate a real treatment plan for these patients to clean up their lid margin disease. So, again, I've offered him this exfoliation treatment in the office. He said, no. He declines to do it because it is an out-of-pocket cost as well to patients to have that procedure. So he declined that, but we did start him on some home treatments. Again, patients are sort of moderately compliant early on and the compliance goes down with time. But after 12 weeks of sort of being on his tail to get this lid margins cleaned up, he looked better. We were able to proceed with cataract surgery. But of course, lid margin disease, it's -- you can't just do the cataract surgery and then drop it because the mite load recurs and the bacterial load and the dry eye symptoms secondary to all of this recur. So, postoperatively, he has significant ocular surface disease symptoms. He has morning stickiness of his lids, really a recurrence of the Blepharitis, redness, foreign body sensation. So we've instructed him to continue his lid hygiene, again, with limited success due to compliance and it's really difficult because these patients are on medications at home for other illnesses, and it just becomes a real burden on their life. They're able to do eye drops, so we give them artificial tears, they're able to continue those, but scrubbing their lids at night and doing hot compresses really falls to the wayside for these patients. But at the end of the day, he feels the cataract surgery made him feel worse because his dry eye symptoms and his lid margin disease symptoms got worse. And so, we end up with an unhappy patient. So we turn sort of an asymptomatic patient into a symptomatic patient. We know that cataract surgery patients tend to, even with successful cataract surgery, dry eye symptoms and lid margin symptoms actually get worse after cataract surgery because of multiple reasons, because of the preservatives in the post operative eye drops we use, patients tend to not touch their eyes or do any of their hygiene right after surgery because they're afraid, they're going to injure their eyes after surgery. So any mild Blepharitis tends to actually get worse postoperatively. So we have to do a lot of education to get these patients to kind of get back to their baseline treatment. So, we see these Demodex Blepharitis patients in the young category, and in the older category, non-surgical as well as surgical patients, and it really impacts their quality of life significantly as well as safety for surgery, ability to do their work, ability to really be in contact lenses. And it's so much more prevalent than we realize. Certainly, as surgeons, sometimes we just want to dive in and surgically manage things, but we really learned as an ophthalmic industry and society to step back and treat ocular surface disease, treat lid margin disease first to improve impacts and outcomes in surgical patients as well. Thank you so much for your attention. And with that, I'm going to turn it to Aziz.

Well, it's so motivating and inspiring to hear from clinicians who are on the frontline treating their patients. In fact, I've spent half of my 25 year career in the eye care space, working with doctors like Dr. Farid and Dr. McGee, launching new products and building new categories in the eye care space. And I'm looking forward to doing just that with the approval of TP-03 later this year, building a new category that will serve 25 million Americans with a product profile that is curative in nature. We're also looking forward to sharing with you our detailed plans of how we intend to commercialize TP-03 and put it on the path to blockbuster success. What you're going to see in our plans is 2 things. One, a thoughtful, creative and detailed plan ensuring that we'll get out of the gates quickly post approval. Two, that we put the patient and physician at the core of everything we've done in our launch planning. It's imperative that they get to see the benefits of this product and that we make that process smooth and seamless for both of those key audiences. There's 4 key elements about what we're going to talk about today. We're going to talk about the platform we've built, all the work we've done to prepare for launch. Neera Clase, our Head of Market Access, is going to talk to you about our pricing, our payer feedback and our innovative high-touch approach to distribution, ensuring that patients can get this product in their hands easily. And I'll come back at the end and talk to you about what you can expect to see post approval and in the months and quarters to come. As Bobby mentioned earlier, it is all about education, driving that awareness in the marketplace, and we've done just that. We've launched 2 innovative campaigns. We started with the physician audience with a Look at the Lids campaign, which launched late last year. This campaign employs every eye care doctor to start an eye exam by looking at the lids, having the patient look down and looking for those collarettes, that tell-tale sign of disease so that when they see them, they know that patient has Demodex Blepharitis and would be apt for treatment. That campaign has garnered over 2 million media impressions, and it's driving action. Over 200,000 visits to our website. Both of these metrics are increasing, so we're seeing lots of positive momentum. In fact, building on that momentum is what prompted us to launch, "Don't Freak out. Get Checked Out!", a campaign that's targeted towards empowering patients, patients like the ones you heard from Dr. McGee and Dr. Farid, ones that are experiencing that frustration, that build-up on their eyes, the redness, the debris, imploring them to go see their doctor and have a conversation to understand that if the root cause of this disease is a mite infestation that can be treated. These campaigns have built significant momentum and are really priming the market for our product launch. We've coupled our disease ed efforts with high-impact education on the scientific side as well. In fact, these efforts have reached our target audience multiple times. We've done this through building an MSL team that is comprised of all optometrists. So as we said at the top of the call, doctors educating other doctors. We've also helped build the scientific evidence in this space, multiple posters presented at major conferences and multiple peer-reviewed articles in major journals. Lastly, we've also had continuing education to the marketplace. 35,000 learners, meaning we've gotten to this audience multiple times. We've built tremendous momentum and deep understanding of the disease, and we see that the physician audience is ready for a solution. In fact, we've measured this time and time again. We've done this through market research, and we see that ophthalmologists and optometrists see it, believe it, and intend to treat it. Meaning, when we do our awareness, trial and usage research, we see that over 2/3 of physicians surveyed say that they understand looking for collarettes is an important part of the eye exam, and that when they see collarettes, over 70% know that this means the patient has Demodex Blepharitis. And when they know that the patient has Demodex Blepharitis, over 90% said they would treat it. with an approved product. Now, this is really remarkable. I've been doing this a long time. And to see an intent to prescribe number over 90% is rare. It speaks to the need in the marketplace, and it speaks to the powerful product profile we have in TP-03. And most importantly, it speaks to the readiness of the market for a solution. So, you can imagine that we're eagerly building our sales force to meet the needs of this physician community. We intend on building an experienced, nimble and knowledgeable salesforce that will be targeting 15,000 doctors that make up 80% of all the prescribing in this space. We've already built the sales force leadership, a group that has strong frontline experience, launch expertise, and of course, depth in eye care. In fact, these 15 sales leaders have a combined 100 years plus of eye care experience. Now they're tasked with hiring the next 85 sales representatives around the country that will serve this audience. We've equipped them with all the data needed to punch above our weight. We know where these diagnosed patients sit today. We know who the early adopters are and we know where the volume sits today in terms of prescribing. So we're going to be able to direct this sales force in a very targeted and precision manner to best serve this physician audience. And now that we've gone through the platform, understanding the platform we've built, the team we're building from a sales force perspective, the next step is ensuring that we can get this product in patients' hands. I'm pleased to turn this over to Neera Clase, our Head of Market Access, someone who has built her career on launching innovative products and creating new categories in biotech. I'm sure you'll see that creativity and thoughtfulness as she walks you through our reimbursement and pricing plans. Neera, over to you.

Thank you, Aziz. In this section, we're going to highlight Tarsus' approach to access to reimbursement and how we are focused on establishing a new standard of care. As you all have heard from Aziz and Bobby, Tarsus is gaining commercial traction through our impactful and creative disease education campaign. Equally important is that the product needs to be priced right, covered by payers and affordable and accessible to patients who are at the center of everything we do. In my 25 years of doing this, this is my first opportunity to launch a potential curative product with no other competition, and I'm thrilled to share with you our disciplined approach to access and affordability, covering 3 main areas: First, patient distribution; second, payer response; and third, pricing. Our TP-03 pricing approach reflects innovation and category creating value. In this chart, we're looking at the eye care space. On the left, you see commoditized drugs for glaucoma and dry eye disease, which are in competitive and generic areas and range in price between $300 and $600. As you move to the right, you see drugs that become more specialized and target conditions such as retinal disease. That can run over $2,000 per injection. Given the curative product profile and defined course of treatment for TP-03, we intend to price it between $1,500 and $2,000 per prescription, which places us in a whole new category that reflects our standard of care potential. Additionally, when you look at the annual prescription cost, our pricing also provides a great pharmacoeconomic value for payers with many patients needing 1 prescription per year. Over time, starting in 2025, we will likely see retreatments. To reiterate, at the pricing band of between $1,500 and $2,000, we are establishing a pricing category that reflects our curative product profile while still providing value for payers. With our pricing strategy established, we are actively engaging payers in discussions, including pricing and access. From launch in 2023 to steady state in 2025, payer coverage will build over time. In 2024, with half of our payer mix being commercial, you will see some early payer coverage wins with the majority of commercial lives being covered by the end of 2024. And in 2025, we will be building our Med-D coverage and phasing out our bridge program. Our gross to net discounts will be higher in 2023 and improve as we build payer coverage throughout 2024, ultimately reaching steady state in 2025 as we build and secure Med-D coverage. As you are aware, payers often take a critical lens to new products. However, we are seeing strong payer interest and a desire to cover TP-03. To date, we have engaged key payers, driving 95% of all prescription volumes. I personally have been at each of these meetings and heard consistent, positive payer feedback. Some of these quotes and their reasons to support the product are shared on this slide. What has stood out for me, the most comes from one of the largest Med-D national plans, who shared, "This is really a very nice product that addresses a true unmet need, and we will absolutely cover it." The most important key takeaway from our payer engagement is that 100% of payers have expressed a willingness to cover TP-03. With the strong payer response, we need to also make sure that patients have access to TP-03. Patient distribution and financial support are paramount because this is what ensures we get product in patients' hands. Our unique approach blends a breadth of retail pharmacy with a patient-centric model that leverages tech-enabled services, ultimately driving 2x the fill rate versus a traditional retail approach. This model also provides patients like Zach, who you saw on my first slide, and providers like doctors McGee and Farid with support and services to get patients on therapy affordably and broadly. This is also important financially as it allows us to take a more disciplined approach in optimizing gross-to-net and our discounting strategy. Before I turn it back to Aziz, I want to emphasize the value of TP-03 and Tarsus. One, payers have expressed a willingness to cover TP-03. Two, we have an innovative approach to distribution, ensuring patients get the product affordably. And three, we are creating a new standard of how to price this product. All of these things will help lay the foundation for TP-03 to be a blockbuster and Tarsus' success. With that, I will turn it back to Aziz.

Well, thanks so much, Neera. I think you all see a very detailed and thoughtful plan to pricing and reimbursement that Neera shared. You've also seen the momentum we built heading into this launch. So what can you expect to see post August? Well, in 2023, we're going to get out of the gates quickly on that path to blockbuster potential. This year is all about driving demand through early adoption, optimizing that physician and patient experience, ensuring that physicians can get this product in the patient's hands and that that process is seamless and easy for patients. We'll, of course, be using discount programs and bridging to make that process easy for patients, but that will continue to evolve as we develop reimbursement and ramp our revenue in 2024. Each quarter, as we win commercial lives of coverage, we'll continue to ramp our revenue in accordance. That ramp will continue in 2025 when we expect to get broad Medicare coverage. Therefore, being able to accelerate our demand and net revenues as well as optimize profitability, on that clear path to $1 billion potential. So, how do we intend to get there? By addressing the patient population we talked about earlier. There are over 7 million patients in the clinic today looking for relief. This includes 1.5 million patients that are already diagnosed with Demodex Blepharitis. Also includes 1.2 million patients with dry eye who have Demodex Blepharitis and can use a different treatment than they're getting today. We can quickly establish usage there and then build also in patients coming in for cataract surgery or patients like the one Dr. McGee talked about, that can't stay in their contact lenses. Those segments combined equal a large multi-billion dollar market opportunity. But if we only took just the diagnosed patients, that 1.5 million patients that are in the clinic today diagnosed at the WAC price that Neera mentioned earlier, $1,500 to $2,000 per script, at a conservative 50% gross-to-net. In 4 to 6 years, you can easily see us being at $1 billion in peak sales. We've built tremendous momentum pre-launch. We put all the plans in place, and we have a clear and thoughtful approach to commercializing TP-03 post approval. We are well on our way and we intend to serve this 25 million patient population as we commercialize our first product. With that, I'd like to turn it back over to our CEO, Bobby to wrap us up.

Thank you, Aziz. Wow, we covered a lot today. As you can see, we're built for this. We have special leadership with special skills in launching products. We understand this launch and we're ready for this launch. And we are going to pioneer a new category with a cure. By doing that, eyecare will have its next blockbuster in TP-03. There are 2 keys to our success in this launch. First, premium pricing, because we have a product that really delivers value. Secondly, broad patient access, because we have millions that we need to serve. So there's a real opportunity, as you've seen today, to drive near-term value, through FDA approval and launch of TP-03. We will have a successful launch. And beyond that, we are on a path to creating the next leading eye care pharma company. That's because we have a strategy to do more. We have pipeline programs this year reading out Phase II proof-of-concept studies. We also see a lot of opportunity in the eye care space to create new categories with great new products. So, thank you for your time today and looking forward to questions.

Thanks, Bobby. As a reminder, to ask a question, please submit your questions in the Q&A chat box and then click send. Our first question, Bobby, can you talk about your disease education efforts and how you believe these activities will translate into launch success?

Thank you, Dave. We're creating a new category. That was central in starting the company that was very motivating, how can we serve millions of patients that have no drug, and that's required, from the start, thinking about how to educate patients, doctors and payers. So on the physician education side, it's really been about getting the messaging out there in an action-oriented way. We heard from Aziz about that. "Look at the Lids" "Don't Freak Out. Get Checked Out!" for the patients, and then having doctors educating doctors. So we're going to continue to do those efforts and you'll see those ramping as we get into launch.

Thanks, Bobby. Your next question. If DB is such a big market opportunity, why have other companies in eye care not pursued a treatment for this?

Yes, that's something we get asked a lot. And it goes back for me to 6 years ago when Michael Ackermann and I were thinking about this together. And we saw that Blepharitis had been understood for a long time, but we saw this uptick in literature around Demodex mites. And in fact, we heard over the years, companies have thought about Demodex mites, but nobody had ever thought about it with a drug. So we're timed well and we have an incredible drug. As you've seen, the drug really delivers curative outcomes, durable outcomes. So we feel blessed. We feel fortunate that we're in this time at the right time with the right drug, right team, as you've heard today, to deliver this to millions.

Next question. Do you think there is any economic impediment to prescribe TP-03?

We've talked about strong outcomes leading to strong economics. We have an incredible commercial team. So I will ask Neera to expand upon that further.

Yes. From an economic perspective, there is a tremendous amount of value for this product. And basically, the product is going to be reaching many patients affordably. We've gotten a lot of positive response, and we are preparing really thoughtful and thorough patient services, and payer engagements.

Yes. And I'd add to that too. From a physician perspective, you think about practice dynamics. What we hear from both ophthalmologists and optometrists is that these great outcomes are good for the practice. If you're an ophthalmologist, this is going to help patients that are -- you heard from Dr. Farid, these patients keep coming back in and they take up time. They take up a lot of chair time because there's not a good solution today. So, actually, having a good solution, what we hear is actually potentially a benefit to these physicians that these patients are going to get served in a more efficient manner. In optometry, I look at what you saw in dry eye, where optometrists are building dry eye practices around a whole category. With the advent of a new category on lid disease, I think that could be a big practice expander for optometry. And as you heard Dr. McGee mentioned, she's at the forefront of medical optometry, which is becoming the next wave of growth in optometry. So I think this will be a great hook for optometrists to continue to drive down that medical pathway, and you could easily see this becoming a really key pillar. So actually, I think it's the opposite, right? Where, to your point, this is going to be pretty easy to access for patients in the long term. I don't think it's going to be an economic impediment. Actually, in many ways, it could be a practice expander or a growth opportunity because these physicians are now able to serve a patient population that they haven't effectively been able to do before.

And I'll just add to that. We heard from Dr. Farid about her diverse practice, and essential to that is actually performing surgery. So she and a lot of the ophthalmologists are telling us that they see these patients, they don't have a therapy for them. And if they can give them something that works durably, they can actually really spend their time doing what they love doing, which is performing surgery and having that immediate effect and vision that surgery confers.

Great. Your next question comes from Patrick Dolezal from LifeSci. We know that following the approval of RESTASIS, the dry eye market grew a multiple fold. What level of market growth do you expect following an approval in Demodex Blepharitis? And are there any learnings from the dry eye experience that are being used in your commercialization strategy?

Dry eye is such a great parallel for us. But remember, it was over 20 years ago that that drug was launched. And Aziz and I had been talking about that really for years before he joined us. And I've learned from Aziz so much about how that market was built. The product was not a blockbuster until it got into Aziz's hands. And -- so I'll pass to Aziz to talk about the parallels that he sees in this.

Yes, thanks for reminding. That was 20 years ago. But there are a lot of parallels there. But there's also some differences, right? So what are the parallels? It's a large underserved market, very similar patient prevalence, population size, no solution prior to the approval of the first product. But with Demodex Blepharitis, there's some key differences, and I think there's really 3. One is, in dry eye, you had a very large over-the-counter market that works really well. I mean, that was a big selling product for a lot of companies. Here, you don't have a standardized route of care, right? There's no standard. There's no place where patients get an easy solution. So this is truly meeting an unmet need. Two, we have a much more developed physician audience now. Back when dry eye products were first approved, it was really driven by ophthalmology only. So you only had about half the audience versus today, where you have deep prescribing and patient management in optometry. So you have a much broader base of physicians that are actively diagnosing and treating. We think that's going to be an accelerant. And then lastly, the disease is a little different, right? With Demodex Blepharitis, you're not only feeling disease, but you can see it. It's a visual disease, right? The collarettes, the redness, it can be seen at the slit lamp. The patients are aware of it. And the last part of it is, it's a mite, right? It's a pretty motivating component of disease. We've seen this in all of our research, and as you can imagine, once a patient finds out, root cause of the disease is the mite, they're pretty motivated to go see their doctor and pretty motivated to get on therapy. So, lots of similarities, but a few key differences that I think actually work very well in our favor as we think to build this market over the next several years.

Great. Your next question. Given the PDUFA is right around the corner, what is the latest dialogue with the FDA? And can you talk about expectations on the label?

Yes, we get asked that a lot. I'm so proud to have Sesha Neervannan leading that effort, our COO. I think this will be his 13th, if I'm not mistaken, NDA approval, most of those in eye care. And what we've heard from the FDA is just clear, consistent feedback and dialogue, great engagement. One thing I can say is, we do not expect to have an ADCOM. And I think what you see from us is, we are getting the product out there within weeks of approval. We will have the sales force out there at approval. And so we're extremely confident about the progress toward ultimate approval of TP-03.

Great. I think this one might be for Aziz. How do you intend to manage DTC marketing campaign spend? Is there going to be more immediate ramp post approval? Or do you intend to wait for some insurance coverage to come online?

Yes, it's a great question, right? I mean, what we said earlier, right. This is very motivating to a patient in terms of understanding the disease state. Our approach is to take a very methodical and thoughtful approach. It's just like everything we showed earlier today. Our focus right now is primarily on that patient -- sorry, the physician education and getting payer coverage, right? We're not ignoring the patient. We actually launched the "Don't Freak Out" campaign. The way to think about that, that's patient education. It's priming for that physician visit. Broader DTC, I think that's going to come online more likely when you have 2 things. One, broad physician adoption. So getting that physician experience that we talked about, getting that really fleshed out, getting doctors very comfortable and actively prescribing the product. And then secondly, getting to the coverage that Neera is working so hard on right now, and we talked about getting to that commercial coverage in '24; '25 having Part-D come on. That would be a great time to think about then ramping up our consumer efforts. When you've got broad physician adoption, you've got broad coverage, you've really opened up the funnel and it would be a real opportune time to start ramping up our patient education and driving more patients into the practice now.

Great. Switching gears to payers. How have discussions with payers been progressing?

Yes, thank you for that question. As we mentioned earlier, we've had tremendous payer response. We've engaged with all the top payers. And what we're finding is a strong, keen interest in the product profile, the curative nature of the product profile, the defined course of treatment and the pharmacoeconomic value. So, to-date, we're in really great discussions. And as we've mentioned, really expect broad coverage by the end of 2024 commercially, and then we'll be building and ramping up Med-D coverage in 2025.

Great. Next set of questions comes from [ Dane ] from Raymond James. Based on your current market research, the number of target ECPs and insurance coverage expectations you just talked about, can you give us a little sense on manufacturing capacity at launch and how quickly you can get to the market?

So, we've taken a really data-driven approach. You've heard Aziz and Neera speak to that. And we've done that with respect to how we're going to get the product to market as well. So we know where these patients are, the majority of them. We know the prescribers, and we are going to get that product out within weeks, and we're going to start with where the patients are most in need. And so, that's how you should expect to see us get the product out within weeks and get it to the doctors who are really ready to treat patients.

Great. Your next question comes from Eddie from Guggenheim. Bobby, can you walk us through the anticipated patient journey?

Yes, that's a great question. I mean, we've seen patients come into our trials. We've studied the epidemiology here and I'll high level it and Aziz has really driven these efforts. We see that, first off, the majority of patients with Blepharitis have collarettes. We saw that in our Titan. Over 2/3 have collarettes. And I think that's central to the patient journeys, how do they come into the office? How they get diagnosed? And I'll ask Aziz to expand further.

Yes, that's great. And we've obviously done a ton of research here. We've actually all spent lots of time in clinics, myself, Bobby, our marketing teams and MSLs are out there in clinics. So we're getting real first-hand experience as well. And I think it will parallel a lot of what you see -- what you heard Dr. McGee and Dr. Farid talk about, which is patients will come in, they'll have some type of complaint. That's going to be the trigger for the doctor to do the slit-lamp exam and look for the collarettes. And we're seeing that -- we saw that in our research, right, 70% of the time, doctors know that if they see collarettes, that they know there's Demodex Blepharitis. It's a very intuitive diagnosis. It can be done very easily at the slit-lamp. So, we see we see complaint, diagnosis, and then when the product is available, we see -- treat it. So the way I think about it is complaint, see it, treat it. It's actually really simple. And then I think you think about those patient segments, right? So there are different entry points. What's that complaint? If you've already diagnosed the patient, it's clear. The patient might be masquerading as dry eye, like Dr. Farid gave an example of. That's a great example. We talked a little bit about patients presenting for cataract surgery. Doctors want really good outcomes. So if you're coming in for cataract surgery, doctor is going to ensure they've got everything covered, including the lid disease. And as you've heard the doctors talk about and we see this a lot, is one of the chief complaints in an optometry practice is contact lens intolerance. So that's another entry point, right? What's my complaint? I can't wear my contacts. Okay, let me look at your eyelids. You have Blepharitis. Let's treat it. So, I think there's 3 things I take away from that. One is intuitive diagnosis. Two is very clear patient segments that we're already working with doctors to think about. And three, doctors are telling us if they see it, they're going to treat it.

Great. Great segue to the next question. You talked about cataracts. You talked about contact lens intolerance. Can you talk about timing and how long you expect penetration to take in those markets?

I think what's one of the take homes from today is, we only need a fraction of those 7 million to get to $1 billion plus peak. And I think as Aziz described clearly those segments, and maybe you could expound further on where the high value is, where the immediate low-hanging fruit is, and then how we're going to get the cataract surgery patients, the contact lens patient?

Yes. And I think, Bobby, you hit the nail on the head, right. It's only going to take a small fragment of these. But you could think about the 1.5 million already diagnosed. I mean, that is obviously the lowest hanging fruit, right? These are patients just like the case studies we heard earlier. They're frustrated. They're ready for something easy and simple and effective. And so I think we're going to see a lot of traction there early on. Dry eye is another example where patients are cycling through meds, and there's a great point of time to intervene between switching what are essentially similar medications in the space. How do you get to cataract and contact lens? I think once doctors start to see a great response in those core patient segments, they're going to quickly say, "Okay, let me be proactive and screen every cataract patient." I put contact lens patients in that same bucket like a dry eye patient, they're complaining. It's a functional issue, I can't wear my contact lenses. So I think that's an area that we'll probably see traction pretty quickly in an optometry practice. Again, if they hear the complaint, they're going to look at the lids, and I think it's pretty intuitive. So, I think there's an obviously low hanging fruit opportunity with diagnosed patients, but I don't think the lag is there for those other segments. I think we're going to see adoption across those segments pretty quickly.

And I want to add a couple of points. So that really goes to the evidence that we're going to continue to generate around TP-03. And we've talked about our pipeline a little bit. We have a study called Ersa that's investigating the effect of TP-03 in MGD Meibomian Gland Disease, which, as you know, is the main cause of dry eye disease. So we're eager to see that data. We're looking at that overlap between Demodex Blepharitis and MGD. And we're looking at a range of outcomes associated with MGD. So that'll be really novel data. The other thing we're going to continue to do is, right in line with those segments Aziz outlined, we're going to continue to generate evidence post market with TP-03.

Great. Your next question comes from Oren from HC Wainwright. This is really targeted towards Selina, who's also on the line and ready to answer questions. But Bobby I'll address to you first. Are you already examining for collarettes now routinely only in Blepharitis or not at all? And what portion of Blepharitis symptomatic patients do you believe are likely actually due to Demodex Blepharitis?

Yes. And Selina is such an expert, and I've really enjoyed her insights today and over the last couple of years. I'll just say that the doctors I speak to, Aziz talked about it, we're at conferences every month or more, and they are just telling us, "Wow, I had no idea until I started having patients look down." We're hearing that, frankly, from investors who talk to doctors that they know. And -- so, Selina, you can talk, I'd love for you to talk about your experience and just how you see that patient coming in, what's their chief complaint? Even if it's not their chief complaint, how do you fit that collarettes exam into your practice and ultimately determine who is a great candidate?

So, 18 months ago, I wasn't looking for this on every single patient. But with this knowledge that we now have and because it is so easy to screen, I look for it on every single patient. So whether they're coming in for their annual comprehensive exam with no complaints or they're coming in for their contact lens exam to renew their contact lens exam. Also, maybe they don't have complaints that unless solicited, they're not going to chime up and say, "Hey, I'm having trouble with my eyelids and how my contact lenses feel." So, now the way that I approach it is every single patient that comes into my practice, we are screening and looking for Demodex and looking for collarettes. So every patient behind the slit lamp, every single time I'm having the patient look down so that I can assess collarettes. And now that I have done that over the last 18 months, we are so much more aware of how [Technical Difficulty] I ask really specific questions to tie it back to their symptomology. So it might be, can you wear your contact lenses as comfortably as you want to be able to? Not how are you doing in your contact lenses? Because they're going to answer fine. So let's just ask questions in a different way, too. But it's really simple, like we've talked about today, just having the patient look down, you have the presence of collarettes. It's 100% pathognomonic for Demodex Blepharitis. And now I have a treatment that I can reach for, where currently we're doing lots of things to try to attack this problem in a not efficient way. And we've talked about that, too, inefficiencies. It's really important when you look at what's happening in the eye care space, we need to be able to see more patients efficiently and we need to take better care of them around the surgical space. So this lets us do that because we can see patients efficiently. We're not using ineffective medications or ineffective therapies over the counter. They're not coming in for multiple visits. So, again, it's going back to that disease education and having the patient look down, and now we're going to have a specific treatment for it. I don't have to do any guesswork.

That's awesome, Selina. Thank you.

One thing on that too Bobby. We talk to all these physicians, and one thing we've heard too is, when there's a solution, the likelihood to screen patients goes up, right? The likelihood to look for something when you don't have a good answer is not as high, even though we're seeing it high in our research. But what we hear very consistently is what Dr. McGee just said, right, which is, if I have a solution, I'm much more likely to look for this because I have a very clear and easy answer. So I think that's going to help us as well.

And you saw that in building the dry eye market, right? So that's a really important point.

That's right.

Maybe a follow-up question. Based on your experience in other diseases that you utilize eye drops, are you confident that Demodex Blepharitis patients will be compliant with an eye drop medication?

It's a central question. Frankly, when we thought about the optimal product, we thought an eye drop with a defined course, twice a day, right, morning and night. That would be the most convenient product for everyone, for the eye doctor and for the patient. And so, we've seen that patients are really adherent in our trials. And I'll ask Aziz and Dr. McGee to comment on how they see that profile as we do our market research, as they think about prescribing that for patients.

Yes. I think that's having a fixed course, that 6-week course. We hear that a lot from our physician colleagues that that's a really important part. But I'm sure we'd like to hear from Selina on that and what your take is compared to maybe some of the other things you're doing in your practice.

It's such a great question. And when you look at chronic therapies, we do see patients start to fall off from that. But we're talking about a medication that a patient is going to use twice a day. That's really key for those contact lens patients, for example, because a patient that you are putting a drop in twice a day, they can put it in first thing in the morning, put their contact lenses in, go about their day, take their contact lens out at night and then apply the second drop. If this was a 3 times or 4 times a day drop, that becomes a much bigger challenge, and it could limit how we use this. But that's not the case because it's twice a day. And then the second piece of this is just taking dry eye, for example, that's a chronic progressive disease that patients are going to be on a medication typically for the rest of their life and we see compliance really go down around month 6, month 8, month 9. But when you have this, that's going to be 6 weeks. And I can tell patients directly, I need you to use this drop twice a day for the next 6 weeks, and then we'll come back and look at everything and reassess. That's really kind to the patient to hear when they know we have a solution and we can set proper expectations of what to expect. So, compliance is going to be different with this because it is a finite amount of time over that 6-week period.

And I'd just remind everyone, right, the presentation that we expect at launch is a 6-week course in a single bottle. So it's, to Bobby's point, very patient-friendly, right, the full course of therapy in 1 script so that the patient doesn't have to make multiple trips to the pharmacy. They get that one script, and that fills that entire course of 6 week therapy.

Great. Next question comes from Frank from Oppenheimer. Can you talk about the potential overlap between Demodex Blepharitis patients and dry eye patients?

Absolutely. I think Dr. Farid mentioned it sometimes with patients masquerading as dry eye disease. And we've talked about the segments that we will address. The 1.5 million with Demodex Blepharitis and the 1.2 million that are on a dry med but have collarettes. So, we see a lot of overlap. In our Titan study, we looked at that, and we found 60% of the patients that had a dry eye prescription had collarettes, meaning they had Demodex Blepharitis. We're, again, looking at that in our Ersa study on MGD, which MGD being the main cause of dry eye. And I think I'll ask Aziz to comment a little further on how we see that overlap in terms of prioritization of the doctors and patients that we intend to treat.

Yes. I think it's spot on, Bobby. I think that it's a high area of focus for us, right? When we think about that patient population of 1.2 million, that's 2/3 of patients that are on a prescription dry eye medication today. And those individuals have collarettes, meaning they have Demodex Blepharitis, meaning they need either a different or an additional treatment. And in many of the cases, like you heard Dr. Farid share, they need a different treatment altogether. And those patients typically, as you heard Selina mentioned, cycle off therapy, right. They drop off because they're not getting the relief they need. And we see that as a really core opportunity, right, addressing a true need for these patients, getting the; one, the right diagnosis; and two, getting the right treatment to hit the need. And you could have concomitant disease, and that's an important opportunity as well, because they're not going to get optimally treated. You're not going to get the optimal outcome unless you're treating the lid disease component of this. So it might be the core disease to your point, right, masquerading or it might be concomitant disease. Either way, I think you're going to see physicians have a patient come in and say, "Okay, you're complaining of this, let me look at the eyelids, make a definitive diagnosis with the collarettes." That works in our favor, clarity. And then they're going to be able to treat the patient appropriately.

Great. Your next question comes from Jason from BofA. What are your plans for post-marketing studies and the importance of generating data to validate mite eradication and how that translates to symptom improvement?

Yes. And I'll reiterate, we are going to continue to generate evidence with TP-03 in post-market Phase IV studies. Those are really going to look progressively at those waves of patients that are coming in with collarettes and generating additional evidence around dry eye, cataract surgery, contact lens intolerance. We're already doing that with Ersa, with the MGD overlap with Demodex Blepharitis study. So, you should expect to see continued robust data from us around TP-03.

Great. A follow-up from Patrick. Could you elaborate on the payer response or payer responses regarding the expected pricing you disclosed earlier today?

Yes. And as you've heard from Neera, we've made that front and center. We've gotten to all the payers, half commercial, half Medicare. And maybe, Neera, you could speak a little bit more about what we've heard.

Sure. Thank you for the question. So, both in payer research and in our live engagements, we have obviously tested the pricing in research, multiple rounds. And then, as we are now having active engagements with payers, we're getting some really good feedback from them. There has been very little to no pushback on our pricing. We are talking with the top payers responsible for driving 95% of all the volume. So we're feeling like they see a great pharmacoeconomic value in it. And as we mentioned earlier, the definitive course of treatment, plus the curative product profile alongside that make this a really good value overall for payers.

Great. Next question from Jason. Back to Jason. Can you share your views, and this is really for Selina, can you share your views on patients likely motivation to treat?

Please, Selina?

Sure. So, patients are going to be motivated to treat for multiple reasons. One, when you tell them that they have a skin mite on their eyelids, that's a high motivation. Number two is how it affects their day-to-day life. So if they're a contact lens wearer and they cannot wear their contact lenses all day, every day, that's a problem. If they have to delay their cataract surgery and they want to see better and they want to move forward with their surgical procedure, they're going to be motivated to treat and be able to do that when they need to do that. Just for example, patients that experience a lot of redness with Demodex Blepharitis, their movie is they don't like the way that they look. And you saw that in one of my cases. And then, of course, patients that have Chronic Chalazia and chronic lumps and bumps, it's the day-to-day, that affects their quality of life, not only how they feel, but how they look. And for me and my patients, and when they come in and they say, "I don't even want to go out in public, I don't -- I need to be able to work and do a meeting like this where patients are focused on -- or people are focused on my face, and I can't put my best face forward because I have this Chalazia on my lid." So, those are all going to be motivating factors. And then when you look at the dry eye patient, we need targeted, specific therapy when they have concomitant disease. That's another big motivating factor because when their tear film is not stable, that affects how they see and their vision fluctuates. So, there's multiple reasons that patients are going to be motivated. And that's why this, to me, translates into the clinic so easily because it's so clear. Patient has collarettes, this is the symptoms, and now, we have this treatment twice a day for 6 weeks.

Thanks. Selina, I love how you said that. We've heard that from other doctors. Look, feel and see, those are really motivating factors for all of us.

Great. Maybe time for one last question from Oren. Sorry, the font is pretty small here. It sounds like in '23 and '24 will require some patient assistance while onboarding coverage. Will there also be some sort of sampling program?

Yes. And as the last question, I want to have Jeff speak to that. I'm so excited to have Jeff aboard. He's launched new categories outside of eye care, and I think having him here to lead this effort is just going to be so impactful for patients. So maybe, Jeff, you could use that to talk about, just in general, how we see the next couple of years.

Sure. Yes. No, as Neera highlighted earlier, we're going to have a very robust bridging program. I mean, really 2023 is going to be about patient access, patient experience, physician experience. And so we do anticipate really just having a very high gross to net during that time frame because of that program. As 2024 comes on, we do anticipate more commercial coverage of about 45% of our patient population is commercial, and that will ramp up quarter-over-quarter until we have broad coverage at the end of the year. And then Medicaid or Medicare will come on in 2025, again sort of ramping up until we get broad coverage towards the end of the year. So, as we start to see payer coverage come on board in 2024, we anticipate conversely reducing our bridging program because we'll have payer access at that point. So that's kind of how we see it over the next 3 years and ultimately broad, broad coverage at the end of '25.

That concludes our question-and-answer session. I'll turn it back to Bobby for a few closing remarks.

I just want to reiterate some key points from today. Firstly, we have an incredible product with an incredible unmet need, a new category, delivering a cure. We've talked about what that means. 25 million Americans, 7 million already in the clinic facing their doctor with real complaints and then 1.5 million really low-hanging fruit, leading to that $1 billion plus peak opportunity. Our cure, I mean, this product delivers really strong outcomes and strong values for every stakeholder involved. The patient who can say, "Gosh, I have relief. I don't have to go back to the doctor every month and get something that's not working." The doctor who can either build their practice or get back to really doing what they love doing in surgery. And very importantly, the payer, who can see the value in this product, a defined course of therapy, at least 6 months of effect. And ultimately something that will recur over the course of the year. So, that value is central. And I think the team that you see here is so built for this launch. We have the capabilities to deliver this to patients, to serve the payer, and we have the capabilities to do a lot more. And so, we are actively working in that pipeline to add another product to the bag that really delivers another category with a great profile. So, a lot more to come. I know we didn't cover a lot of things today, but I can't wait to be back with each of you talking about our anticipated approval and the early days of our launch.