Great. Good morning, everyone, and thanks for joining us for the Tarsus fireside chat. It's our pleasure to have Jeff Farrow with us, CFO and Chief Strategy Officer of Tarsus. To kick it off, you know, to start with, you've had a very successful development of XDEMVY, which is now commercial execution. Maybe just to get everyone on the same page, can you just start with an overview, make sure everybody knows exactly what XDEMVY is, and how you've been so successful?
Thanks, Annabella. It's great to be here, and thanks for having us here. We are a commercial stage company, as you highlighted, and we launched XDEMVY in September of 2023. The launch, as you said, has gone very, very well. We've seen increases and growth in underlying demand and corresponding revenues quarter- over- quarter since that launch. Importantly, you know, we've seen great payer coverage. You know, it was much earlier than we anticipated, and we're about over 90% coverage across the payer spectrum, and that includes Medicare, commercial, and you know, I think that really goes to the value prop for the drug. I think the launch, you know, to your point, has gone well for, you know, several things.
One, you know, the team did a great job about a year ahead of launch, really educating the payers and the eye care professionals on Demodex blepharitis, you know, the sort of unmet need there, the pharmacoeconomic benefit of treating, and you know, that's paid off right after the fact that we got the approval. We were able to hit the ground running with some physicians that were aware of it. Demodex blepharitis is caused by something called Demodex mites, and we all have it on our face and in our hair and kind of gross, you know, but some people just have an overproliferation of it.
These folks that have an overproliferation, you know, see it in the eyelashes, and it's basically these parasites getting into the glands of the eyelashes and, you know, excreting waste and eggs and things like that that can lead to bacterial infections, and it's readily seen by inflammation. You see redness in the eyes or itching and burning. The nice thing about it is it can be very easily diagnosed. Most people that have gone in to see their eye care professionals have gone into a slit lamp. It's essentially the thing you put your chin on, and they look at the back of the eye. If the ECPs ask the patients to look down, you can see these collarettes, which are this waxy cylindrical scrub that builds up around that, and that is pathognomonic for the disease.
It is very easy to diagnose, and it is shown to be, our drug is shown to be very efficacious. We saw over 85% of the patients see clinically meaningful results in our phase III study, and it has got a very safe safety profile as well. I'd be remiss if I did not talk about our pipeline as well. We have got a couple other pipeline assets that we can talk about as well. We have got something for ocular rosacea, again, another sort of groundbreaking potential therapeutic where there are no approved FDA treatments for it. We have got something rather unique for Lyme disease as well.
Great. That was a great introduction. Just going back to the Demodex blepharitis, this is clearly a very large market. You've only started scratching the surface of it, and you're targeting first, I think, only a segment of patients who are treated. I guess, how do patients respond when they realize that they have this underlying condition? And it's not just your standard dry eye, but it's from like Demodex blepharitis. It's from these mites. I imagine uptake would be very rapid. From a commercial perspective, why are you just segmenting the market? I imagine you would be able to go after the entire market very quickly, but maybe you can talk about how you strategize this and how you're staging this expansion into the market.
Sure, sure. Yeah, as you highlighted, there's a lot of patients out there. There's about 25 million patients that are thought to have this disease in the United States. We're initially going after 9 million patients, and these are patients that are actively going in to see their eye care professionals for some underlying disease. About 1.5 million are going in for Demodex blepharitis. We have another 1.5 million that are seeking treatment for MGD, and as you highlighted, also dry eye, contact lens intolerance, as well as cataracts. Those are our initial target, those 9 million patients. We do think as time goes on, some of those 25 million patients will come down and start asking, you know, their physicians about Demodex blepharitis, and that's one of the reasons we kicked off the DTC campaign as well. That 9 million is our initial.
I think the low hanging fruit for us have been the 1.5 million patients that have already been described Demodex blepharitis or already been diagnosed with Demodex blepharitis. These were patients that were coming in complaining about it, probably seeking, you know, therapies that were not efficacious. That is really kind of our, you know, probably our go-to patients out of the gate, but we've seen more and more patients in those different segments get treated as well.
You know, the way we're continuing to sort of expand into that patient category, we call it our four E's, you know, is really education of the eye care professionals as well as the patients, you know, ease of access now that we've got 90% payer coverage, and we've got a sort of specialty pharma-like channel that really sort of helps the patients through that payer process and helps remind them when things are ready for them to pick up or be shipped. Evidence generation, we've got some phase IV studies that will continue to sort of go into those different segments. Just operational excellence, right? Just making sure that we're really sort of playing whack-a-mole and all these things that kind of come up there. That's really kind of how we're sort of doing our plan on that 9 million patients.
The patients, as you asked the question about how do patients react, you know, I think the doctors have learned, you know, to be, you know, cautious how they describe this, making sure that people think that it's not, you know, a hygiene issue or, you know, something that's, you know, wrong with them that really we're all, you know, have this on us. It's just one of those things that some people have more of it than others. In fact, some people don't even mention mites. You know, you just have this disease called Demodex blepharitis, and now we have therapy to help treat you.
Initially, we were hearing things that, you know, some patients were cutting off their eyelashes or shaving their eyebrows, you know, because of their, you know, I don't want to have mites, but I think the doctors and the eye care professionals have learned to sort of really think about how to sort of treat this a little more, you know, I think cautiously when they talk to their patients.
Got it, got it. Just speaking to the segmentation, as you see it, 1.5 for Demodex, others GED, and then cataract, you mentioned that you're penetrating some of these other areas. Have you disclosed how much is in each of the different, what kind of penetration you have in each of these different segments of the population? If the other segments that you've cited have kind of sped up based on, or penetration has sped up based on the success that these physicians have been having for Demodex specifically?
Right. Yeah, we have in the fourth quarter, we disclosed that 40% of our 15,000 targeted eye care professionals have gone into these other segments. It's not something that we have data on sort of real time. It's really having to go back and doing chart reviews is where we get that information in ATUs. So that's the last time we've done that, but we were encouraged, you know, a year into launch that we were seeing these incremental impact on those different other segments. Our sales force, we've got 150 sales reps that are targeting those 15,000 docs, and you know, they're tasked with going through the depth, you know, asking their physician contacts and optometrists to take a look at all their patients.
We know there's no such thing as an asymptomatic patient, and really take a look while the patients are in the slit lamp, do they have collarettes? If they do have collarettes, that's pathognomonic for the disease, and you should consider treating them with XDEMVY as a result of that. That's really some of the effort that we've been seeing in the growth. We started, we hired an incremental 50 sales reps right after Labor Day, and that is, that's we're seeing some nice room in the depth as a result of that roll out of the incremental sales reps.
Okay. Just on that point, why did you feel like you had to hire 50 more sales reps? Is it because of a rapid adoption, or was there difficulty in education? How did you determine the right size for the market?
Yeah, when you launch, you always want to be thoughtful about how we roll out, you know, certain initiatives in the thing. And what we wanted to do is make sure, you know, we had a good number of reps. So we started with 100. As time went on, and because of the payer coverage coming on much more quickly, we realized that it was a good time to pull in our incremental 50 hires. We had originally planned on bringing them in in 2025, but instead brought them in in the summer, you know, 2024 is when we started recruiting for it. And it really was to reduce what we call windshield time. You know, we had some reps that, for example, there was one rep that covered Phoenix, but also covered San Diego, right?
It is probably not the best use of this individual's time to be on a flight or driving around in that territory. It essentially reduced the territory size in half and made it much more efficient for these sales reps to detail the eye care professionals as a result of that, and again, sort of drive that message about looking at all your patients, and if they've got the collarettes, you should consider treating them.
Okay. Has that education, have physicians been rapid to change their, I guess, diagnostic approach to these patients?
Yeah.
Because physicians get stuck in their ways for a while, so I'm just curious how they've adapted.
No, I think that's exactly right. You know, it's a little bit of a journey, right? We had some physicians and eye care professionals that were ready out of the gate and knew about XDEMVY, knew about Demodex blepharitis, and then there were some that weren't that were just, you know, that we had to educate them and, you know, did that with literature and further evidence. What the, you know, the plan now is we've gotten essentially scripts from all 15,000 of our targeted sales reps, and that represents about 85% of all eye care professionals that write scripts for the front of the eye. It is really a targeted, you know, group of ECPs that we're doing.
You know, and there's some that are writing daily, but then there's some that are writing, you know, monthly, and we want to get them going from monthly to weekly to daily. That really is the plan here. It's not, you know, expanding to beyond the 15,000. It's really just getting into the depth of the 15,000 that we're targeting.
Okay. Are they finding their patients readily? Are they in the screening, or have they all had a handful of patients that have been sort of the low hanging fruit for them?
I think initially it was some of the ones that were probably, you know, previously diagnosed with Demodex blepharitis and maybe had, you know, a lot of collarettes and were complaining a lot. As time went on, you know, they've been sort of identifying other patients. You know, one of the things we did early on was, you know, you hear some pushback. It's like, yeah, I know about the disease, but we don't, I don't have a lot of patients that have this. We challenged them and said, okay, here's a little stamp pad that you can sort of stamp every time you see a patient that has collarettes, want to do a stamp. That was really sort of a light bulb going on with some of these ECPs.
It's like, wow, I really do, as much as 50% of the patients coming in daily have these collarettes. You know, that kind of observational effort really did seem to help. As a result of that, I think people are realizing how prevalent this disease is.
Okay. This is a, I guess this is an eradication type of treatment. How should we think about the dynamic where you're treating to a potential eradication? Do you see retreatment of these patients at all? Do they have recurrence of it, or is it a one treatment and done, and then most of them are pretty good going forward?
No, the treatment is a six-week treatment. It's an eye drop that you take in the morning and once in the evening for a period of six weeks. What we saw in the clinical study is subsequent to them stopping, between month six and month 12, we saw about 40% of the patients start to see recurrence of the collarettes in the disease. That's our best evidence at this point that, you know, we expect these patients to see some recurrence. What we've guided the street to think about is not all 40% of those patients are going to come back, you know, the following year. We said, you know, think about 20% of those coming back in the subsequent year. We're collecting real-world evidence as we speak.
At that point, I think we can give some, you know, better guidance on what the recurrence rate is. We do know patients are coming back for retreatment. I would say there's been no pushback on the payer front as it relates to that. There's nothing in our payer contracts that limits refills. What the data shows in IQVIA is it's a high single % retreatment rate. If you go back to the actual cohort data, so go back a year from now and see which patients, you know, are being retreated, you know, we're seeing a higher number, you know, in the low teens. I think we're well on our way to getting to that 20% steady state, and it could even be higher, you know, beyond that.
Got it. I guess while we're talking about reimbursement, you know, maybe we can talk about, obviously it was a very rapid uptake from the payers. You said 90% commercial. Just maybe you can talk about how these patients were clinically treated before that, you know, I guess motivated the payers to take this up so quickly. I mean, people tend to stay away from these specialty pharma drugs because of, you know, payer pushback, reimbursement restrictions, but this seems to have picked up very nicely. Maybe you can talk about what the pharma economic benefit was to the payers, given that I think most people were treated with tea tree oil or compresses really at no cost to them. Maybe you can put it in that context a little bit.
Sure. Yeah, no, you're exactly right. Previously, they were treated with tea tree oil, which is stinging and, you know, patients don't like it, or lid wipes or warm compresses, neither of which were efficacious. What the really the benefit of our medical fair, our access team was getting out there early and educating, you know, ahead of the launch on the disease and the fact that, you know, these patients were likely coming back, you know, multiple times a year to their eye care professionals to seek treatment because there's no efficacious treatment. There's no FDA-approved treatments. This was the only thing you could use. Ours gets to the root cause of the disease, which is killing the mites, and it does that very efficaciously and safely.
It was basically showing the payers that, look, you're getting these multiple visits to the eye care professionals, and it's not helping them. We also saw off-label usage of dry eye medications as well, which are not inexpensive, and they frequently switched. They would maybe try for three months and didn't see anything happening there, so they switched to another dry eye drug. It was really showing them that this was a situation that you treat them for a period of six weeks, you know, in essence, that would be, you know, good for a course of a year.
Okay, excellent. There is no, I don't know, restrictions, step-throughs. You don't need to show that you've been treating off-label with dry eye meds. You don't need to show that you've been using compresses. They are not causing any, giving you any restrictions here.
That's right. Yeah, that's right. The prior auth, you know, in any sort of like, you know, drug like this, that's not generic nowadays, is prior auth the label. We've got a very broad label, you know, for the treatment of Demodex blepharitis. Basically, there's an attestation that the patient has collarettes, which we know are pathognomonic, and in some cases, it has to be treated by an eye care professional, either an optometrist or an ophthalmologist, but that's been the general PAs. In fact, in a couple of payers, we have zero PAs, so they can directly do that. We do things to help out, you know, in terms of making it easy for the physicians. You don't want this to be a burden on the back office for the physicians.
We utilize something called Cover My Meds, which, you know, is very specific for the insurance company. They can just say, all right, Blue Cross Blue Shield requires this. They print it out and then sign it and fax it off. We also have this sort of specialty light program where we have folks in the pharmacies help go through this payer adjudication process for them as well.
Okay, got it. Have you laid out any guidance with regard to gross-to-net? How much sampling are you able to do? How much have you had to do? And do you have a gross-to-net expectation that's been laid out? I think I remember it's been pretty moderate for this day and age, especially for.
Yeah, no, you're exactly right. We're very pleased with how things have gone. We had in the last quarter a gross-to-net discount of about 47%. As you know, there's usually Q1 dynamics with copay resetting and things like that. We expect it to decrease quarter- over- quarter throughout this year to get into the low 40s by Q4. We expect to exit in the low 40s there, say 42%-43%. That should be more or less our steady state gross-to-net discount absent that Q1 dynamics that you typically see there. To your point, it's much better than typical eye care products in dry eye. You can see, you know, 70%-80% gross-to-net discount. We're pleased where we landed there.
Okay. Did you say you had sampling or no sampling?
We have very limited sampling. You know, there are some doctors that, you know, want to try it out, but we do not really have much sampling as we see. Most of the doctors have tried it already. They have gotten good feedback from their patients. You know, we really do not see a need to do much sampling there.
Okay, great. Maybe we can talk about other segments of the market you're looking at outside of Demodex. Do you need to generate any additional data for, say, meibomian gland dysfunction for dry eye? What kind of phase IV's are we looking at here?
Yeah, we're looking at phase IV for all of those other segments. We recently demonstrated some really nice data in MGD. You know, something that, you know, I don't think has been demonstrated before, actually seeing patients that have Demodex blepharitis and MGD, you know, seeing an improvement in meibomian gland secretion score and seeing a real improvement going from sort of the, you know, either completely blocked glands or the sort of toothpastey secretion that comes out of the MGD to a nice olive oil type secretion. We saw an improvement in the secretion scores, as well as the number of glands that actually, you know, were able to produce this optimal secretion as well too. That has really resonated with the eye care professionals. They haven't seen anything before like that.
That has been encouraging data for the patients, as well as the eye care professionals that treat MGD there. We're also looking at, you know, other phase IV studies in things like contact lens intolerance, down the road, maybe cataract surgery, treating patients, you know, before they go in for cataracts such that you get a better outcome subsequent to the cataract surgery. There is some literature out there that you do tend to see a balloon in Demodex blepharitis and the Demodex mite subsequent to the surgery. We're going to be looking at potential studies in cataract surgery as well.
Got it. Okay. Is this part of the 25 million that you're talking about, or are we talking about a separate market?
This would be part of that 25 million. These would be patients that have been thought to have Demodex blepharitis.
Okay, got it. Maybe in the little time we have left, you can talk about the other ocular conditions that you're branching out to, ocular rosacea and Lyme disease is a little bit not ocular.
Right.
Perhaps you could talk about that as well.
Exactly. That was probably better suited for somebody else, somebody else's hand ultimately. Ocular rosacea is something we're excited about. This is something, you know, that we had a phase II study in derm rosacea. We hit our primary endpoints, but it is a very competitive space there, and we were thinking about partnering it. When we shared this with the eye care professionals, they said, "Have you thought about ocular rosacea? Something I see in my practice all the time, and there's just nothing out there from an FDA-approved process or FDA-approved therapeutic." There are about 15 million-18 million patients that have this disease, and the vast majority are caused by Demodex mites. We know we're very efficacious in killing these mites. It was something that we did a further market research, and there really was a bear there.
We are going to be initiating a study later this year in ocular rosacea, focusing on, you know, really what right now we're developing the primary endpoints. This is a brand new study that nobody's done in ocular rosacea before. Two telltale signs, one is the redness that's around the eyes, as well as essentially these veins that build up on the upper eyelid that you typically don't see in patients that don't have ocular rosacea. We're developing a scale that can be utilized by all clinicians that are going to be in our study that can reproducibly say, "Okay, I see this as being a grade three. I see this as being a grade four." Once we've developed that scale, we can move into that phase two study.
You know, we think there's a high probability of success there just given our experiments with Demodex blepharitis. And then on Lyme, we're looking at an oral prophylactic for the treatment of Lyme disease. It kills the mite before it transmits the bacteria that causes Lyme. You know, we showed a great study called a tick kill study that killed over 98% of the ticks within the 24 hours of treatment, which is the, you know, prior to the window that it transmits it. So we're looking at a phase II-B study there, but ultimately we think this should be probably better detailed with, you know, somebody else like a big pharma company.
Got it. Since you're the CFO, I'm going to ask you to talk about financials, cash runway to profitability, and what you might need to, what kind of sales level you need to reach to hit break even.
Sure. Yeah, no, we ended Q1 with a nice balance sheet. We had about $408 million in cash, and we believe that's sufficient to, you know, continue on, you know, this growth path that we have for XDEMVY and then also take those two studies into phase II studies, as well as the phase IV program. We haven't guided to profitability yet because we haven't guided to revenue yet. This is really a category creating. There's not a good analog out there. The big unknown right now is the impact to DTC on the back half of the year. I think until we get our arms around that, we have not provided that revenue guidance at this point, but maybe in the future.
Great. I think we are out of time, but that was a great overview. Thank you very much, and congratulations on such a great launch.
Thank you, Annabella. Appreciate it.
Thank you so much.