Conference Transcript - TARS 2026-06-02

Lachlan Hanbury-Brown, Analyst — William Blair

Hi, morning everybody. I'm Lachlan Hanbury-Brown, one of the biotech analysts here. I cover Tarsus Pharmaceuticals. Before we get started, please visit williamblair.com for any and all relevant disclosures. With that, I will hand it off. We have Jeff Farrow, the Chief Financial Officer and Chief Strategy Officer, and Dave Nakasone, Head of IR. I'll pass it off to Jeff for a brief presentation and then we'll jump into Q&A. So when we get to the Q&A portion, and feel free to chime in if you have any questions.

Jeff Farrow, CFO

Perfect, thank you, Lachlan, and I appreciate the invitation to attend the meeting here. As Lachlan highlighted, we're Tarsus Pharmaceuticals. I do encourage you to take a look at our most recent SEC filings, if you consider an investment, and take a look at the risk factors in there, and here's our forward-looking statement. So, Tarsus is a commercial-stage organization that is based in Southern California, Irvine. We've been very intentional about how we have done everything in terms of this organization. We're intentional about how we developed the clinical studies, how we've commercialized, and I think we're well on our way to becoming an eye care leader. XTEMV is basically in its third year of launch and has done extremely well. we've guided to $670 to $700 million in revenue for the year, and the commercial trajectory has been up and to the left ever since we started. We also have an interesting pipeline, considered to be pipeline in a product. It's really the same active ingredient that's utilized in Xtemvi. We're also purposing for something called ocular rosacea, and then also a prophylactic treatment of Lyme disease. So Xtemvi is the only FDA approved therapeutic on the market for the treatment of demodex blephritis and it targets the root cause of the disease. It kills very selectively and safely the mites by targeting the GABA chloride channel and we've shown very strong clinical efficacy and safety in our clinical study. It's a six-week course of treatment and it essentially, as I highlighted, targets the root cause, it kills the mites that caused damodexplothridae. We also have very strong IP, we've got Composition of Matter that gets us to 2032 with two years of Hatch-Waxman extension included in that, and then we also have nine issued and orange book listed method of use and manufacturing patents that get us to 2038, so a very nice long runway. way. So we recently gave updated guidance on Xdem-V. We had previously assumed that this was going to be a blockbuster plus or a billion dollar plus opportunity, but given the trajectory of the launch, we've now given updated peak guidance that we think we can get to $2 billion plus just in the United States, just with Xdem-V in demodex blephritis. It is a breakthrough therapeutic there's nothing else out there for the treatment of demodex blephritis previously there was use of homeopathic methods including tea tree oil and lint scrubs that just weren't efficacious nor did they get to the root cause of the disease so people have asked us you know how do you continue to grow this franchise and demodex blephritis in particular and it's really the drug is just delivers on all fronts. It's 85% of the patients saw clinically meaningful results. And if you do your KOL checks, you will find that many of the doctors will tell you that it's even better than that in real world. So it's very efficacious, very safe. And we're seeing nearly half of the targeted eye care professionals that we're pursuing, which is about 15,000, half of which are ophthalmologists, half of which are optometrists, are prescribing on a weekly basis. And our goal is to continue to educate on the front that all patients that have cholerets, that's pathogenic for the disease, and there's no such thing as an asymptomatic patient. And then we started a DTC campaign effort last year, and we've got a very unique commercial that seems to be resonating out there and driving more awareness about demodex blephritis. So it essentially moved from 0% awareness of demodex blephritis to one in four of the patients that are presenting at the eye care professional now know what demodex blephritis is from an unadded awareness perspective. So it's pretty amazing when you think about this campaign just started a year ago. And we're also continuing to drive depth by providing more reasons for the eye care professionals to treat. So there are phase four studies that we have kicked off that will provide more clinical data that will provide more ammunition for the eye care professionals to treat. We recently had some data that came out last quarter showing that patients that have Hortiola or Chalasia have a high prevalence of demodexplothritis. So 70% of those patients have also demodexplothritis. So it's another reason for these doctors to treat. And we're really just scratching the surface on the total addressable market here. So we've only treated 600,000, and we're initially targeting these 9 million that are in the smaller circle here. These are the patients that are actively going in and seeing their eye care professionals, not just for demodexpulthritis, but for things like contact lens intolerance, cataract surgery. And so these are the doctors, those 15,000 doctors that we're really educating and targeting here with our 150 sales reps but beyond that there's 25 million patients that are thought to have demodex blephritis and so we're opening up the top of the funnel by our DTC efforts here so both through expansion through education on the eye care professional side as well as DTC campaigns driving the top of the funnel is essentially contributing to the increased revenues that we're seeing quarter over quarter I touched on this already so we did highlight that we expect peaks revenues of about two billion and these are some of the key initiatives that we're talking about driving deepening utilization we're seeing retreatment rates come up it's essentially what we saw is that we kill the mites but within six to twelve months about 40% of the patients see reinfestation in the eye follicles and get the disease again so we've guided to long-term retreatment rates of about 20 percent so that's included in our baseline uh peak revenue adjustment uh peak revenue assessments of two billion dollars as well and this is the first year we've given guidance like i highlighted we expect to have uh revenues of net sales of about 670 to 700 million we do see seasonality in our business in q1 there's typically a dip in the number of patients that go in to see their eye care professionals and we did see that in q1 but i would say less so than what we saw in the competitive dynamics of other eye drops that saw decreases in dispenses as much as 20%, we saw about a 4% drop. So we're still exceeding expectations when you think about the eye care spaces alone. Q2, we typically see an upramp in the number of visits and the dispenses and we've seen that since the start of the quarter and we actually have just recently hit an all-time high in dispenses as well. So we're very confident about achieving that revenue guidance for the year. Typically in the summertime we do see a drop in growth. We still continue to see growth but typically what happens is patients and eye care professionals go on holiday and since we're generally an NRX business we do see a drop in Scripps as a result of that but fourth quarter again tends to be one of our highest dispense numbers as well so we expect to see that seasonality as well and that's all based into our guidance. And then finally we do have some exciting pipeline opportunities as I highlighted earlier we've got the Lyme prophylactic, potential prophylactic. The theory here is we would kill the tick before it transmits the bacteria that causes Lyme disease and we showed in an earlier study that we killed 95% of the ticks within 24 hours so that's before the transmission of the bacteria there. So an exciting opportunity for a oral prophylactic that's on demand and durable that lasts 30 days. And then inocular rosacea is also another program that we basically listened to our eye care professionals. They were saying this is a disease that we see all the time. There's nothing else out there. And the incidence of this is pretty high. It's about 15 to 18 million patients that have this disease. And the vast majority of of those diseases is caused by Demetix mites and we know we're very efficacious at killing mites. And so it's another exciting opportunity. Both of those pipeline products will read out in the second half of next year, or the first half of 27. And so, you know, we think this does create an opportunity for us to be an eye care leader. We've got an exciting pipeline that's based on the same active ingredient that's in Lodalaner and we're really excited about, you know, continuing to grow Extenvy as well as to turn these data cards over at the pipeline. With that, I'll turn it over to Lachlan again.

Lachlan Hanbury-Brown, Analyst — William Blair

All righty, thank you, and again, feel free to raise your hands if you have any questions. But maybe to start, you know, you touched on some of the updates you recently provided with both giving guidance for the first time, increasing peak sales guidance, talking about the increases in unaided awareness you've seen with DTC so far.

Jeff Farrow, CFO

So maybe if we just go through them one by one, on the 2026 guidance, maybe it's 50ish percent growth at the midpoint, what are the pushes and pools there yeah that get you to that level either up or down no exactly as you highlighted is about 50 growth which is a nice growth to see coming from year two to year three and it's multifactorial for what we think is going to continue to drive that growth in not just in 26 but beyond so it's the DTC campaign you know that's going to be increasing the top of the funnel you know driving more patients into that nine million TAM and then secondly it is is just continuing to educate eye care professionals that they should look for colorets, which are the hallmark for the disease. And there's no such thing as an asymptomatic patient. So all these patients suffer if they have the colorets. And so they should be looking at not just the patients that are coming in complaining about demodexpulthritis, but they should be looking at their contact lens patients, patients that have MGD, patients that are going under cataract surgery. So just looking across the board and continuing to treat. We recently hired about 15 to 20 key account leaders that will be focused on the highest potential eye care professionals. And they will be working with those territory leaders to increase that depth of prescribing. And then there'll be additional phase four studies that we'll be reading out, much like the Chilesia hordiola study, that will provide more reasons for these doctors to treat. So theoretically, they understand that having cholerets you know could be implicated on these diseases but having phase four studies that actually show that data I think is going to be compelling reasons for them to continue to treat.

Lachlan Hanbury-Brown, Analyst — William Blair

Okay so how much of an impact of those sort of incremental investments being the new key account leaders the new patient segments having this year versus just this is really just sort of continuing the growth rate you had last year?

Jeff Farrow, CFO

Yeah no we think it's going to continue to continue to add you know, ROI on those particular investments. So the 15 to 20 KALs that we've hired, you know, will really hit in the back half of this year and continue to see growth. And then, of course, that will continue in 2027. And then the DTC campaign, we've invested about $80 million in that in terms of a budget this year. And that ROI is already at a multiple of that investment. And we think that ROI will continue to expand over the year. We just recently have put out a few initiatives we've got some refreshed commercials that will be coming out both on the disease education and then we've also had a recent partnership with John Cena that you might have seen that he was talking about his disease experience there where he had red itchy eyes and he basically was saying I kind of self diagnosed I thought I was just getting older wasn't getting enough sleep went to the eye care professional and found out I had an XMV and he's been a passionate believer in it ever since then and so so that has increased you know website traffic and continued understanding of the disease but it also makes it more human too right if John Cena feels comfortable about talking about the disease then you know people don't feel uncomfortable talking about it as well so it's resonating on multiple fronts there and continuing to drive I think patients into the top of the funnel yeah I mean thanks to some of of the reactions down here.

Lachlan Hanbury-Brown, Analyst — William Blair

I think it's definitely resonating. So I mean, how should we, obviously the DTC as you sort of touched on has had a pretty big impact so far, both in terms of the unaided awareness, but also the ROI that you're seeing and website clicks and so on. How should we think about these refreshes, both the John Cena element and the other refreshes you've done, like the incremental impact of them on top of the existing impact that you were having with the DTC campaign?

David Nakasone, Head of Investor Relations

Yeah, so, thanks a lot. I think a good way to think about it is that they should be incremental and almost like steps. So, you know, John Cena, we started him maybe a couple of weeks ago, and you're already seeing the impact to website visits, click-throughs, et cetera. You know, the things that we really triangulate towards are what are people doing on the website? Are they just clicking through it? Are they taking the quiz? Are they looking for a doctor? All these things help drive more patients into the funnel, and that's kind of how we view it. When you think about the key account leaders, again, it's we didn't expand any territories. They're really there to be additive, dropping into their specific accounts and helping out the sales reps in all the territories and really driving depth of adoption. These folks have tremendous amounts of experience across all of iCare, and to see that come to fruition probably more, as Jeff alluded to, in the second half of the year, we just onboarded them, so we're going to give them a little time to get up to speed, but the expectation is, Lachlan, that they're going to be pretty additive in the back half of And then, yeah. Yeah. Go ahead. So for those not in the room, the question was essentially around reimbursement, co-pay, what do patients typically pay, I think is what you're asking, right, Miles? Yeah, so look, we have really great coverage. There's essentially 90% coverage across commercial, Medicare, Medicaid, and other. Our goal when we launched was to have everybody pay around or no more than $50. In many cases, most patients pay around $30. There's assistance programs to help. I think in Miles' case, he got it for even less than that. So it just goes to the, it just shows the quality of the reimbursement landscape that we've, our team has established with all the payers. It's, and the other thing I think Miles didn't ask, but it's pretty easy to get. So when you go to the doctors and they diagnose you, they see the colorets, when you're walking out the door essentially you're gonna get either a phone call or some sort of text message or communication and essentially it's gonna be how do you want the product. We can either ship it to your house or your office or you can come into a brick-and-mortar. So it's it's pretty seamless and pretty affordable.

Lachlan Hanbury-Brown, Analyst — William Blair

So what causes the disease and what causes it to come back? Oh, yeah.

Jeff Farrow, CFO

Everybody has mites on their face and in their hair. Just some people have an over-proliferation of it. And it's not caused by hygiene. It's not any ethnicity that has a higher propensity of it. The only thing that has a higher correlation seems to be aging. And that's probably because of the facial sort of conformations that happen. Your eyeballs tend to sink into your sockets a little bit more. Some of the skin gets a little bit more lax. So there seems to be a higher correlation in as you age and that's why we have about 45% of our patient population is is Medicare as a result of that and it's just unknown as to why more people have or some people have an over proliferation of it but it does tend to these mites like this oily sebaceous environment so they really like to get into the back of the the eyelashes there and so once you do you go through a course of treatment, you kill the mites, you get to the root cause. We saw in our clinical study between month six and month 12, about 40% of the patients recur. And so what typically would happen is the mites just migrate back up into the eyelashes and ultimately cause reinfestation and see the demodex blephritis reoccur there. And what we've done is guided. So our clinical study saw about 40% of those patients saw recurrence within month six to month 12 but clinical environment tends to be you know the perfect place you know to measure these things in real world it's probably less and so we got it to expect a retreatment rate of around 20% you know per year yeah happy to so the question was described a little bit more about the ocular rosacea program and the Lyme program as well as the the change in the formulation so the great question we did highlight that it's the same active ingredient they are in different formulations so the ocular rosacea is in a sterile gel formulation so when we think about treating these diseases we're very intentional about how we choose which formulation to do it we knew you know for Xtem-V and for demodexpulphritis to get into the back of the the eyelashes and the follicles an eye drop is the preferred method there we also did the similar thought on the rosacea side and so having a sterile gel formulation that sits on the skin for a while allows for better penetration of the active ingredient into the eye but we also wanted to make sure that it absorbed and didn't hamper people that wanted to wear makeup as well so that was part of the formulation considerations there and then the Lyme disease is a small oral pill that you would take in the theory here is you would take it once a month and over the course of the tick season and so you could think about maybe once a month for four months to cover you for the tick season and so the nice thing about it is it's it's almost on demand you could take it the night before going into an infested area and have therapeutic levels within eight hours and it's durable for 30 days on the Lyme disease program we're enrolling 700 patients. The key endpoints that we'll be looking at is safety because it is a prophylactic and that's why we have a fairly large phase 2 study. And then we'll also be looking at drug levels within the system as well, the PKPD, because we knew based on our phase 2a study, this tick kill study, that we have to get to certain levels in order to get to that 95% efficacy rate. So we'll be measuring that and then we'll also be looking at some key biomarkers as well for Lyme disease. On the ocular rosacea side will be it's a 16-week course of treatment with the sterile gel and what we'll be measuring are the two components that I mentioned earlier that are really the chief complaints of the patients that is this redness as well as the pronounced vessels that are on the eyelid that's those two of the hallmarks of the disease and what our conversations with the agency said was you know if we show improvement we don't have to show cure but show improvement in either of those endpoints that could be a phase three approvable endpoint and so we've developed a proprietary scale that is measuring improvements in the redness as well as the reduction in the vessels and so that's the purpose of this this study here so then both of those will read out in the first half of 2027. Yes, so the market size on the ocular rosacea, there's thought to be about 15 to 17 million patients. So it's a big unmet need. There's nothing out there from an FDA approved therapeutic. And the vast majority is thought to be caused by Demodex mites. So another white space opportunity that really has nothing out there to help these patients. And then the Lyme disease, Pfizer has a vaccine that they just recently read out on they did not hit their primary endpoint they still state they're going to file but they have said that they believe it's a billion dollar plus opportunity so uh two big potential opportunities the nice thing about the ocular rosacea opportunity the call point is synergistic with our extend v call point so it'll be detailing those same doctors there so very synergistic from that perspective okay so it's good transition to the pipeline um you know with the ocularization program one of the things you've had to do was basically develop your own end point to measure these two manifestations so can you maybe talk about the work you

Lachlan Hanbury-Brown, Analyst — William Blair

did there to develop that but also validate it and ensure that each site is sort of measuring it consistently and a score of X at this site is going to be the same at all the other sites exactly yeah no I think that's really key to our success here is really making sure since we're developing a scale that you know essentially proprietary, there's nothing out there that's commercial off the shelf that we can utilize.

Jeff Farrow, CFO

So we spent a lot of time essentially taking photos of patients in the slit lamp environment and having examples of each of these type of things. Grade one redness reduction, you know, grade five pronounced vessels. So spent a lot of time getting a good variety of patients to take a look at and took pictures and then we've had a finite number of clinical sites that we're working with such that we can really make sure that they are well trained on these different levels and we also take photographs as well so we do internal reviews as well just to see how they're scoring compared to the clinicians at the clinical sites as well so very tailored approach to this because we think that's one of the key factors of success here.

Lachlan Hanbury-Brown, Analyst — William Blair

I was going to ask if there was a central review there. Maybe on sort of inclusion exclusion criteria this is a disease that presumably hasn't been that well known because there are no drugs for it so probably a lot of patients aren't formally diagnosed or I'm not actually sure if there are formal diagnostic criteria how do you approach sort of defining enrollment criteria to ensure that you're getting the right patients yeah we take a pretty broad approach here because we could potentially so we've taken a pretty broad approach here but we're of course you know going

Jeff Farrow, CFO

to be noting the characteristics of the patients that enter as well right so we're going to be noting the patients whether they have cholerates and whether they have demodexplophritis so that'll be one of the key things that we'll be taking a look at and then from an inclusion exclusion criteria you know they can't be taking steroids or anything else that could be treating the rosacea as well so those are the key sort of exclusion criteria and then you know I know you did a phase 2a study in papulopustula rosacea that's right similar but maybe not quite the same how should I think about the read-through from that maybe what's what is similar and what differs as you move to technically maybe a different disease different manifestation different skin Yeah, no, that helps us as we thought about developing this clinical study. So this PPR study is a type of rosacea that's actually caused by mites as well. And we showed a phase 2A study that showed a clinically meaningful reduction in, and significantly meaningful reduction in the redness as well as the pustules. And we also showed that we, through skin sort of samples, that we were killing the mites as well. so we think that gives a nice read-through in terms of this ocular rosacea program you know while they don't have the pustules they do have the redness and so you know that'll be you know that went into sort of our thinking on the powering side of things but also how to think about the formulation as well too so so those were really I think give us some better confidence on the potential outcome here okay so you touched on formulation maybe what what's changed from that formulation and have you done testing to see how much Lodolanus still gets into the skin? Yeah we do test to see you know how what gets into the skin this is a sterile formulation the PPR gel was not sterile this is also the orbital area is a more delicate area as well so we want to make sure that the excipients don't cause any irritation that could result in a placebo effect or actually irritate the eyes and the patients that maybe have rosacea so we've reduced the number of excipients there so those were the key things that really really went into the thinking on the gel formulation.

Lachlan Hanbury-Brown, Analyst — William Blair

Awesome then on TPO5 Lyme disease probably said the exact same thing last year but that's something that's interesting to me having spent a lot of time in the northeast you're always worried about the ticks so you know I understand the study isn't powered for efficacy As you said, that's probably more of a vaccine-sized trial to get a real efficacy signal. But you said you're looking at biomarkers for Lyme disease. Obviously, one of the things you'll be looking at is the PK, just to check that you're getting the levels needed. Are there other biomarkers of the disease that you will be looking at to, again, maybe not give a significant read one way or the other, but show trends that you were impacting infection rates?

Jeff Farrow, CFO

That's right. Yeah, there's some exploratory endpoints we're looking at. that are essentially not approvable biomarkers in the FDA's eyes. There is an effort, as you highlighted, there's a lot of interest in Lyme disease these days. And there's a initiative that HHS put forward called LymeX really focused on trying to get consensus around some of these biomarkers. And is there a way to see approval more quickly versus a disease prevention approach, which can take you know multiple years to enroll and then of course go through the regulatory pathway and so this is one of the initiatives that the agency is trying to put forth is taking a look at some of these biomarkers and testing them out and seeing if there is a approach in which you can take a biomarker approach and perhaps an accelerated approval approach where you get approved on a biomarker that is likely to predict clinical benefit and then you run a confirmatory study subsequently to show disease prevention type of thing and so we're taking some of these biomarkers that are being explored and using them as exploratory at this point so.

Lachlan Hanbury-Brown, Analyst — William Blair

Yeah I certainly feel like I see a headline about Lyme disease more or less every day now. It seems like it. Because we're coming into the season. Yeah so on the on the topic of accelerated development it sounds like that's obviously still pretty early the Lymex program and and what they're talking about maybe do you have any sense of what that might look like or when you may get a sense from them of if there is a possibility for an accelerated development I mean are they they doing work to validate biomarkers or something or is it still more the sort of ideation phase I think it's early days at this point right and I think the Lymex initiative got kicked off a couple months ago so I think it's more in the ideation phase but they're really wanting to move forward as quickly as they can on trying to develop something and get it on market.

Jeff Farrow, CFO

That said you know we are having conversations with the you know the agency and in various other government affairs perspectives to just highlighting you know the importance of getting treatment for these patients and so you know we're having multiple dialogues as this goes on I mean we we have some time in which to have these conversations and maybe have a different outcome prior to partnering this, you know, ahead of a Phase III study and so you know this is something that could be helpful as you think about a partnering pathway as well.

Lachlan Hanbury-Brown, Analyst — William Blair

I realize we're over time so I will leave it there but if anybody has further Q&A we have a breakout session in Burnham B starting in 10 minutes.