We're excited to have Tarsus Pharmaceuticals here with us. For those of you who don't know me, I'm Glenn Santangelo. I'm the specialty pharmaceutical analyst at Jefferies. Representing the company, we're excited to have Aziz Motala, who's the Chief Commercial Officer, right to my left. To his left is Jeff Farrow, the CFO of the company, and sitting in the front row here is David Nakasone, who heads the investor relations function, for the company. So if anyone has any questions, David's your man, or you can hit us up and we're happy to try and help. Well, Tarsus has been an exciting story year to date for anyone paying attention. They've had a very successful product launch. They're moving up to the big room now, right? Seeing plenty of investor interest, so a lot of good things.
Well, listen, why don't we start... We'll, we'll start with financials, Jeff. How about that?
Yeah.
'Cause we got a lot of questions for the Chief Commercial Officer-
No doubt, yeah.
Around the launch, so let's hit Jeff up first. I mean, the ink on the Q1 press release is barely dry, right? So let's just talk about, you know, the fact that the product was launched in the fall.
Yeah.
You reported, you know, some revenues in the September quarter.
Yeah.
You know, it was at $13 million in the December quarter-
Right
... and now 24 and change in this quarter, so it speaks to, but let me, let me let you give the, the first quarter highlights and, and the financial highlights, really, year to date since the launch.
Yeah, sure, happy to do so. So, thanks, Glenn, for having us here. We appreciate the invitation. As you highlighted, we had recorded product sales of about $24.7 million, almost $25 million. Really, our second full quarter of revenues since the launch. And it's, you know, we are very pleased with, you know, how the launch has progressed. I think, you know, Aziz and his team have really done a nice job setting the trajectory for the commercial launch, you know, a year in advance, really doing the disease education. So out of the gate, when we got approval, we were able to start generating revenues, and that's been, you know, super helpful. The other aspect of the disease, it's very easy to diagnose.
You know, you take a look down at the eyelashes when the patient is in the slit lamp. And then thirdly, you know, the patients feel and look better, which is always a good thing when you've got a therapeutic. And then finally, payers are seeing the value prop here. So all of that's really added to our continuing revenue growth there. On a dispense perspective, we dispensed 26,000 bottles, which was nice growth over the prior quarter.
Our gross to net discount was about 55%, which, you know, quite frankly, at the beginning of the year, it's sitting where we were, or actually, at the beginning of the launch, we were not expecting such a robust gross to net yield at this stage, so we're quite pleased with where we are on that aspect of it. So all in all, we're looking, you know, for next quarter to see similar growth to what we saw in the dispensed bottles between Q4 to Q1. So we expect to see some nice dispensed bottle growth as a result of that.
You know, Aziz, since this is sort of a general meeting, maybe it's worth taking a step back, and maybe I should have did this first, but, you know, can you talk about XDEMVY and Demodex blepharitis and sort of what it is, how big, you know, of a market opportunity it is, and just give people a little bit of background? And then we'll sort of talk about pricing, commercial coverage, and that sort of thing.
Yeah, sure. So Demodex blepharitis, I think, is a really interesting disease in that blepharitis as a whole has been a key disease area for eye doctors, and an area that we uncovered several years ago is that Demodex mites, these little microscopic bugs, are actually the root cause of the vast majority of blepharitis that doctors see in the clinic. And that's really key because with lotilaner, with XDEMVY, we have a drug that targets that root cause. This disease affects 25 million Americans. These are people that are seeing the eye doctor on a regular basis, and of those 25 million, we really focus our efforts on 7 million that we say are sort of at the bottom of the funnel. And this includes patients that are already diagnosed.
This is about 1.5 million patients that are already diagnosed with Demodex blepharitis, and prior to XDEMVY being available, they had no good solution. This includes patients that are on dry eye medications. About two-thirds of patients that are on an active dry eye medication actually have either concomitant disease or were misdiagnosed, and they have Demodex blepharitis, and they're getting treated inadequately. And then we see another opportunity with patients that are coming in to improve their vision. So they're coming in for cataract surgery or because their contact lenses don't feel good. They can't stay on their contact lenses, and both of these patient populations have a large percentage of patients who actually have Demodex blepharitis. So if you're coming in for cataract surgery, this could be a confounding factor or if you can't stay in your contact lenses.
So these are all patients that are actively in the clinic looking to enhance outcomes, and these are the areas we see doctors utilizing XDEMVY first. They typically start with the diagnosed patient, and then they quickly move to dry eye, cataract, and/or contact lenses. So those represent clear market opportunities at the bottom of the funnel, but they also represent the use cases where doctors are starting to see traction with the product.
So, Aziz, I mean, you're talking 25 million people. That's 78.8% of the people in the United States, right? There's a big portion of us that wear glasses, right, and have been to the optometrist or ophthalmologist. Could you talk about how difficult it is to diagnose Demodex blepharitis?
Yeah, this is one of the most interesting parts because this disease is actually very easy to diagnose. One of the hallmark signs of the disease is collarettes or crusting on the eyelids, and what that crusting is-- and I think we're far enough after lunch where I can talk about this. This is actually the waste material of the mites. So these mites live at the base of your eyelashes. They live in the follicles, and as they propagate, they die. Their exoskeletons, their waste material all extrudes and forms a resin-like crusting on the base of your lashes, and that's called the collarette. The doctor can see the collarette during a normal eye exam. They use a slit lamp or a microscope to look at the eye.
All they need to do is have the patient look down so they can look at the upper eyelid, and if they see this crusting, they can make a definitive diagnosis that you have this disease. The crusting or collarettes are important because that's the easiest way to diagnose. That's how every doctor diagnoses it, and this is also the primary endpoint in our clinical studies. In our clinical studies, we looked at the clearance of these collarettes as the primary endpoint. Clear efficacy on the most ideal way to diagnose this disease. Every doctor, every eye doctor can do it. Takes about 10 seconds at most, and you have a definitive diagnosis, and you have a definitive treatment.
Before XDEMVY, what was the treatment protocol?
Yeah. So before XDEMVY, if a doctor diagnosed this, they would typically defer to a homeopathic approach, as they tell you, put a warm compress on it. In some cases, they would tell the patient to use things like lid scrubs or tea tree oil. The goal there is to debride or kind of eliminate some of the crusting, but nothing they could do would get to the root cause.
To eradicate the mites.
To eradicate the mites, exactly. So this is where XDEMVY, so everybody that we've talked to, if they were managing it that way, they would switch all their patients to XDEMVY, and a lot of our early use was that, right? "Hey, I, I was doing this before. I was already treating it with what was available, and I'm using XDEMVY because it's twice-a-day drop for six weeks, and it gets to the root cause.
Okay. Can you talk about the pricing strategy for the drug, and let's talk about the payer coverage to this point and how those conversations are trending?
Yeah. So the two things that really allowed us, so we spent a lot of time with the payer upfront, right? To really understand the value that we can drive, and that helped us set the WAC price, which is $1,850 per course of treatment. And it's different, right? Because this is a single course of treatment that the patient would take once a year, in some cases, maybe twice a year, if it recurs. Eventually, it will recur, but what we say is, you know, 1-2 treatments a year is how we model this. $1,850 WAC, and what we've said is a steady state gross to net, we expect of about 50%. That was all done with work with the payers.
We've done a lot of research there, and what we've said now, based on all the work we've done, is that 2024, we'd built commercial coverage. And we've already had some really big wins there. We've announced in the last couple of quarterly calls. We're continuing to make progress with the commercial payers, and we expect to have sort of steady state, full throttle commercial coverage by the end of this year. And we're, we're also in active negotiations with Part D payers, and we expect the Part D coverage to kick in in 2025. And once we get both commercial and Part D in tow, that's the ticket to us getting to that 50% steady-state gross to net, where you're gonna yield anywhere of upwards of $900 a bottle.
All right. Could you talk about your field sales force, and sort of the prescribers, you know, the unique prescribers at this point?
Yeah. So we have a sales force that's out there currently of about 100 people. We're in the process of actually expanding that by about 50%. So, by the end of the third quarter, we'll have about 150 in our sales organization, and we're focused on 15,000 doctors who are ophthalmologists and optometrists that actively manage disease. They're front-of-the-eye doctors. So these are doctors that manage things like dry eye, allergy, cataract surgery, contact lenses. What we're seeing so far is about 60% of our volume is coming from optometry. About 40% is coming from ophthalmology. We're seeing great uptake across both, because these patients are ubiquitous in these clinics. We've announced on our last call, we had about 8,000, just over 8,000 doctors.
So well over 50% of our prescriber base in just a couple of quarters have already trialed the product, and our repeat prescribing rate is over 50%. So this isn't a case where doctors are writing one script and then not doing it. They typically write one, two scripts. They typically get to 5 or 10, and once they get to 5 or 10, they really take off. So this is a product that, as the doctors get more and more experienced, it potentiates more utilization in the practice. And a lot of things that Jeff said, right? Why is that? It's because it's a new product, it's a new disease category that they're managing, but as they do this, they're seeing really robust results.
So as they see those positive results in those follow-ups, really stark contrasts from pre and post, then they're starting to look for the next patient. They're starting to expand the utilization in their practice, and we really see a takeoff point. Once they get past 10 cases, doctors really start to take off.
You said 15,000 eye care professionals. Is that split pretty evenly between optometrists and ophthalmologists?
Yeah, it's about 50/50.
Can you talk about the physician education efforts at this point? How well do you think DB is known at this point? How well do you think XDEMVY is known? I mean, you said you're expanding the commercial sales force by 50%. Do you feel like there's a lot more work to do in terms of physician education or?
Yeah. So, you know, the physician education is something we started a couple of years back. Even prior to the launch, we started educating the marketplace on the disease state. We have a MSL team that's comprised of all eye doctors, so we had all optometrists, medical sales force, or medical, science liaisons that are out there, so they were out there educating the market. So I think in terms of disease awareness, we've done a remarkable job. You can't go to an eye clinic, a doctor's not aware of it. I think doctors are very well aware of XDEMVY as well. So I think disease education is shifting focus from disease awareness to really thinking about where to use the product, and that's really where the sales force expansion comes into play. We can reach all the 15,000 doctors with our current sales force.
Where we see an opportunity is to see these doctors more often and educate them on, "Did you know that it's prevalent more so in your practice than you think? You should think about your cataract patients. You should think about your dry eye patients, your contact lens patients." So I think the disease education is still important as we build the new category. It's really focused now pivoting towards where in the practice you use it versus just broad awareness of the disease. So I think doctors are aware of the disease, but we need to continue to educate them on, "Hey, you know the disease is there, but it's also ubiquitous in these certain patient types where you can get great success.
You know, speaking of my own personal experience, right? Every time I go to the optometrist, I have my head in, yeah, my eye in the slit lamp, you know, the whole time I'm there. You know, outside of just normal good health and hygiene standards, I mean, is there a financial reason why an optometrist or an ophthalmologist might be incented to want to look for this and ultimately prescribe XDEMVY?
... Yeah, this is one of Jeff's favorite dynamics of this product in the marketplace, so we like talking about it. So for an ophthalmologist, they are really seeing lots and lots of volumes, right? So cataract surgery is becoming more and more common as we have an aging population, and they need to stay in the clinic or they need to stay in the OR and do surgeries. And if they have patients that are not adequately treated in the clinic, this eats into their OR time. So for an ophthalmologist, this really optimizes the practice. They have a clear diagnosis, a clear solution, and that gets a patient good outcomes and then optimizes the ophthalmologist's time to get them back in the OR. So it's a clear practice optimizer.
For an optometrist, what we're seeing is a trend towards optometrists wanting to shift towards medical management, right? So if you're just doing vision care as an optometrist, you're getting paid via VSP. And if you can shift patients, more and more patients, to medical management in your practice, medical patients typically reimburse twice what a vision patient does, right? Because you're actively managing a disease. So if I can code an ICD-10 code for, say, Demodex blepharitis, I now have a patient who's a medical patient that gets reimbursed twice as much. So there's an incentive for an optometrist, and more and more optometrists are now shifting their practice focus. And this is a dynamic you see, because as contact lenses go to online ordering, as frames and lenses go to things like retail, like Warby Parker, those are becoming commoditized.
A way to sustain and grow your practice is really taking on more medical management, and they see Demodex blepharitis as a real catalyst to driving greater utilization in the medical side of their practice, and it reimburses better.
Jeff, just putting some numbers behind that, and you touched on some of these before. But when we go back to 4Q, the scripts were 17,400, I think, and that jumped to 26,000 in 1Q. At the same time, gross to net went from 58% to sort of 55%-
Yeah
... percent. I think, you know, you guys have said that should settle in around sort of 50%. But listen, not, not that you want to talk about 2Q at all, but, you know, when we looked at the April scripts on IQVIA, it looks like we saw a nice bump in April sequentially from March of about 16%. And so is it fair to say that the hope is that you just continue to sequentially build as awareness builds, and we should see some continuous improvement on the gross to net as you sign more of these contracts, ultimately reaching that 50% by the time we, you know, you get to the government contract, in the second quarter? The Part D contracts in the second quarter of 2025. Am I thinking about the progression correctly?
You are, yeah. No, we are well on our way to get the broad coverage on the commercial side of the house by the end of this year, and then we're starting, you know, to have the formulary discussions with the Medicare agencies now. We should get that coverage start to kick in, in the beginning of 2025, and we'll pull that through, through the middle of 2025 and should get to that 50% gross to net yield by that middle of next year.
Well, you know, early on in the launch, there were some criticisms around the IQVIA data, and people were looking at Symphony and looking at sort of other things. You know, has the quality of the IQVIA data, at least as it relates to XDEMVY, improved with each passing month?
I wouldn't say it's improved with each passing month. I'd say it's improved from since the launch. There's always gonna be a delta there. They're always making, you know, an estimate of a couple weeks ahead. So I would say it's gotten. The error bars have gotten narrower, but they're still not perfect, and sometimes they're up a week, and sometimes the following week they're off but in a negative territory. So, what we guide people to do is when they think about. If you have to look at IQVIA, we say don't look at it weekly, but look at the trend over a period of a month. You know, that's the right way to look at it.
Okay. All right. Jeff, maybe let's talk for a quick second about the balance sheet, right? You've done some financing already this year. Can you talk about the level of cash on the balance sheet at this point and some of the additional financing that may be available to the company? Because I think where I'm gonna go next, diseases, we're gonna talk about the increase in the operating expenses with the salesforce expansion. I think you have some DTC plans, but I think it's important for us to understand how well-capitalized the company is.
Yeah, sure.
We're not well-capitalized.
Yeah. No, we are well-capitalized.
Okay, well, that's right.
So, we ended Q1 with about $300 million in cash and investments. We also refinanced our existing debt and entered into a term loan with Pharmakon, drawing down an incremental $40 million that actually came in in Q2. So we have $75 million on our balance sheet in terms of debt right now, and we have the ability to tap into $125 million, you know, should we desire to. There's no immediate need to do so. In fact, I think what you're gonna come on here in a few minutes is, you know, we're capitalized enough as is without tapping into that term loan to support some of those initiatives on the commercial side as well.
Can we talk about some of the, I mean, you talked about the sales force expansion. What about DTC advertising or how you're thinking about ramping up the marketing efforts in the back half of the year?
Yeah, absolutely. So one of the hallmarks of how we've approached this launch is being very thoughtful and purposeful in how we scale our efforts. We started with a very focused footprint in our sales force, and as we've gotten momentum and seeing the traction, now we're expanding the sales force. And I think, where we really see an opportunity is to increase the frequency to the doctors. We know where we can put these reps now because we've got good market insight. We know exactly what messages resonate, so we're gonna be able to deploy these reps even more effectively than how we deployed our initial wave of field force. And then once you do that, you're gonna have an even more sort of primed physician audience, where you've gotten even-...
broader depth of prescribing, more utilization, and that sets the stage for then, a consumer effort. So you've got more doctors writing. The doctors have made this a habit in their practice, so when you're pushing patients into the practice, you've got a doctor that's ready to sort of make the diagnosis and treatment. So we think that Q4 is a great time to think about that. We should have great momentum. The reps are gonna be trained, deployed, and out there. They're gonna have some time to get up to speed in their territories, and they should have, you know, kinda hitting that critical momentum, and then you start to drive the, the DTC. The other advantage of timing the DTC there is we should, as you brought up earlier, see some steady improvements in gross to net, so we're gonna be netting out even more per script.
So the ROI per script we generate is gonna be better. So that's a great time to do it. And all the research we've seen so far tells us that patients are gonna be very responsive. If you think about it, right, "Hey, your eyes don't feel good. They don't look good. They're red and crusty. Did you know the root cause of this disease is a mite? Would you want to see your doctor?" "Yes, please, right away." So it's very intuitive, right? It's an easy story to tell. It's one that elicits a very strong motivating response from a patient, and we're gonna be doing it at a time where we've really set the stage on the prescriber audience.
We've set the stage with the payers and really gotten to a great gross to net into 2025, and that's a great time to do it, and we think that this is a market that's primed, and this is a great way to continue to build and carry momentum.
But Aziz, can you help us-
Yeah
... also think about the patient TAM, right? Because you talked about expanding the prescriber base, right? And you know, we talked about the 1.5 million Demodex blepharitis patients, but you also mentioned dry eye patients, cataract patients, people, their contact lenses. And so, you know, you build a patient TAM that's significantly bigger than just Demodex blepharitis, right?
That's exactly right. So I think that DTC is gonna be a catalyst to, you know, we say there's 7 million in the clinic out of the 25 today. Can we grow that 7 million beyond, right? Can we get 10, 12 million in the clinic that are actively raising their hand, saying, "Hey, screen my lids," and in all these categories? So we see this as a way to really feed the bottom of the funnel, from the top. And I think that, again, it's thinking about those three levers, right? You got the prescriber base going. You've got your payers lined up, and then you can really open up this TAM and, and really open the funnel up to bring more patients to the bottom of the funnel. So you're right.
But there's also opportunity here for label expansion, right? You have three pipeline programs, TP-03, TP-04, and TP-05, and in MGD, rosacea, and Lyme disease. Could you maybe talk about those pipeline programs and how you think about over the next kinda couple, few years, what those opportunities could mean commercially for the company?
Sure, yeah. No, they, we had a lot of data cards turn over last quarter, as well as early December. The MGD data card turned over in December, and that's perhaps the most synergistic opportunity for us. It's essentially the mites get into the lower eyelid and cause MGD and the blockage of the glands, and we showed two very compelling data points when we turned the data card over. The improvement and these are objective measures of evidence of improvement. The MGSS score, it was improved not only statistically significantly but also in a clinically meaningful manner.
And then also the number of glands that were secreting the optimal secretion, which is a score of three, also improved from, you know, below one to about six, and, you know, anything that's greater than two is considered clinically meaningful. So beyond being stat sig, it was also very clinically meaningful. So that is exciting data, and the KOLs we've talked to are very enthusiastic about that. There is a discussion we're gonna be having with the FDA about the path forward on that one. We could potentially seek a label-enhancing opportunity, but there could also be a scenario where we take a disease education approach and publish this data, get it out in the public domain, and perhaps deal with it that way.
The other two pipeline products that you talked about, TP-04, was in rosacea. This is a type of rosacea. It's called papulopustular rosacea, and we showed clinically meaningful improvements in the resolution of the lesions and also the overall appearance of the rosacea. But even more interesting, when we showed that data publicly, several of the eye care professionals came to us and said, "Hey, I would be very interested in seeing a product like this for ocular rosacea." They see this rosacea around the eyes, which there's nothing out there. It's a complete white space. So we're exploring this to see if there's a potential market there. We're gonna develop a TPP, do some market research, think about pricing.
But that would also, if it does look like there's something there, that would be something that would be synergistic with our sales force and that we could detail our eye care professionals on. Highly likely, we'll partner the derm indication of that, since it's a different call point and a different sort of infrastructure that would be required for that. And then finally, TP-05 is our Lyme program, a really exciting program. It's a Lyme disease prophylactic. We showed some data in February that showed that we killed 98% of the ticks before the window of transmission of the Lyme bacteria that happens. And so, that's not only within tick kill rate within 24 hours, it was durable for 30 days.
So in essence, you could be taking this out before going on a hike and be covered the next morning from, you know, potentially catching Lyme disease. So we're gonna have a discussion with the agency on that, and think about next steps forward. But again, because of the high number of patients that we'll have to enroll for a phase III study, plus the commercial infrastructure, probably better suited for somebody else's hands.
All right. We're pretty much out of time, but I just want to ask this last question. I mean, it seems like there's a lot of data points that are sort of lined up in your favor, and it's really down to a commercial execution story. And is there anything on your radar screen that you're concerned about, you're hearing any negative feedback, anything that you're paying extra attention to? And then I want to give the two of you guys the last word. Anything you want to leave with the investment community here?
So I think from the launch perspective, I think this has exceeded even our own expectations. I think we've got great tailwinds here. I think as Jeff said, the, the prescriber experience has been phenomenal. The doctors literally send us messages and images every day of patients that have great outcomes. I think that's a great testament. We're able to help a lot of patients that way. I think that is continuing. I think our efforts in expanding the sales force will help continue that momentum, and then I'm really excited about being able to empower the consumer because I do think, as you mentioned earlier, Brian, this is gonna be a way to open up this TAM and treat even more patients.
To us, I think it's, it's really a clear path forward of continuing to execute in a smart way, make really measured bets of where we can accelerate this launch. I think the last piece is the payer piece is coming online, and I think that's just gonna facilitate a high-value outcome for all the efforts we're doing. I think we've got a clear plan in place. We're gonna continue to execute that, and if we do that, I think we've got a lot of room to continue to grow this product and build a really high-value market.
Okay, great. Well, we'll leave it there. Aziz and Jeff, thank you very much. And David, thank you all very much for coming, and we thank you all for your participation today.