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. Then we'll jump into Q&A. When we get to the Q&A portion, feel free to chime in if you have any questions.
Perfect. Thank you, Lachlan. 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. Here's our forward-looking statement. Tarsus is a commercial stage organization that is based in Southern California, in 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. XDEMVY is basically in its third year of launch and has done extremely well. We've guided to $670 million-$700 million in revenue for the year, 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 XDEMVY. We're also purposing for something called ocular rosacea, then also a prophylactic treatment of Lyme disease. XDEMVY is the only FDA-approved therapeutic on the market for the treatment of Demodex blepharitis, it targets the root cause of the disease. It kills very selectively and safely the mites by targeting the GABA-gated chloride channel. We've shown very strong clinical efficacy and safety in our clinical study. It's a six-week course of treatment, it essentially, as I highlighted, targets the root cause. It kills the mites that cause Demodex blepharitis. 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.
We also have nine issued and Orange Book-listed method of use and manufacturing patents that get us to 2038. A very nice long runway. We recently gave updated guidance on XDEMVY. We had previously assumed that this was going to be a blockbuster plus or a billion-dollar-plus opportunity. Given the trajectory of the launch, we've now given an updated peak guidance that we think we can get to $2+ billion just in the U.S., just with XDEMVY in Demodex blepharitis. It is a breakthrough therapeutic. There's nothing else out there for the treatment of Demodex blepharitis. Previously, there was use of homeopathic methods, including tea tree oil and lid scrubs that just weren't efficacious, nor did they get to the root cause of the disease.
People have asked us, how do you continue to grow this franchise and Demodex blepharitis in particular? It's really the drug just delivers on all fronts. 85% of the patients saw clinically meaningful results. 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. It's very efficacious, very safe. 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. Our goal is to continue to educate on the front that all patients that have chalazions, that's pathognomonic for the disease, and there's no such thing as an asymptomatic patient.
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 blepharitis. Essentially moved from 0% awareness of Demodex blepharitis to one in four of the patients that are presenting at the eye care professional now know what Demodex blepharitis is from an unaided awareness perspective. It's pretty amazing when you think about this campaign just started a year ago. We're also continuing to drive depth by providing more reasons for the eye care professionals to treat. There are phase IV 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 hordeola or chalazia have a high prevalence of Demodex blepharitis. 70% of those patients have also Demodex blepharitis, it's another reason for these doctors to treat. We're really just scratching the surface on the total addressable market here. 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 Demodex blepharitis, but for things like contact lens intolerance, cataract surgery. These are the doctors, those 15,000 doctors that we're really educating and targeting here with our 150 sales reps.
Beyond that, there's 25 million patients that are thought to have Demodex blepharitis, we're opening up the top of the funnel by our DTC efforts here. 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, we did highlight that we expect peak revenues of about $2 billion, and these are some of the key initiatives that we're talking about. Driving, deepening utilization. We're seeing retreatment rates come up. Essentially what we saw is that we kill the mites, within 6- 12 months, about 40% of the patients see reinfestation in the eye follicles and get the disease again.
We've guided to long-term retreatment rates of about 20%, so that's included in our baseline peak revenue assessments of $2 billion as well. This is the first year we've given guidance. Like I highlighted, we expect to have revenues of net sales of about $670 million-$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. We're still exceeding expectations when you think about the eye care spaces alone.
Q2, we typically see an up-ramp in the number of visits and the dispenses. We've been seeing that since the start of the quarter. We actually have just recently hit an all-time high in dispenses as well. 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. Typically what happens is patients and eye care professionals go on holiday. Since we're generally an NRx business, we do see a drop in scripts as a result of that. Fourth quarter, again, tends to be one of our highest dispense numbers as well. We expect to see that seasonality as well. That's all based into our guidance. 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. We showed in an earlier study that we killed 95% of the ticks within 24 hours. That's before the transmission of the bacteria there. An exciting opportunity for a oral prophylactic that's on demand and durable that lasts 30 days. Ocular 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. The incidence of this is pretty high. It's about 15 million-18 million patients that have this disease.
The vast majority of those diseases is caused by Demodex 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 2024 or the first half of 2027. 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 lotilaner, and we're really excited about continuing to grow XDEMVY as well as turn these data cards over in the pipeline. With that, I'll turn it over to Lachlan again.
All righty. Thank you. Again, feel free to raise your hands if you have any questions. Maybe to start, 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 we've seen with DTC so far. Maybe if we just go through them one by one. On the 2026 guidance, maybe it's 50%ish growth-
Yeah
at the midpoint. What are the pushes and pulls there?
Yeah
that get you to that level and either up or down?
No, exactly. As you highlighted, it is about 50% growth, which is a nice growth to see coming from year two to year three, and it is multifactorial for what we think is going to continue to drive that growth, and not just in 2026, but beyond. It is the DTC campaign that is going to be increasing the top of the funnel, driving more patients into that nine million TAM. Secondly, it is just continuing to educate eye care professionals that they should look for collarettes, which are the hallmark for the disease, and there is no such thing as an asymptomatic patient. All these patients suffer if they have the collarettes.
They should be looking at not just the patients that are coming in complaining about Demodex blepharitis, but they should be looking at their contact lens patients that have MGD, patients that are going under cataract surgery. Just looking across the board and continuing to treat. We recently hired about 15- 20 key account leaders that will be focused on the highest potential eye care professionals. They will be working with those territory leaders to increase that depth of prescribing. There will be additional phase IV studies that we will be reading out, much like the chalazia/hordeola study, that will provide more reasons for these doctors to treat.
Theoretically, they understand that having collarettes could be implicated on these diseases, but having phase IV studies that actually show that data, I think, is going to be compelling reasons for them to continue to treat.
Okay. How much of an impact are 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?
Yeah. No, we think it's going to continue to add ROI on those particular investments. The 15-20 KALs that we've hired will really hit in the back half of this year and continue to see growth, and then of course, that will continue in 2027. The DTC campaign, we've invested about $80 million in that in terms of a budget this year. 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 XDEMVY. He's been a passionate believer in it ever since then. That has increased website traffic and continued understanding of the disease. It also makes it more human too, right? If John Cena feels comfortable about talking about the disease, then people don't feel uncomfortable talking about it as well.
It's resonating on multiple fronts there and continuing to drive, I think, patients into the top of the funnel.
Yeah. Based on some of the reactions down here, I think it's definitely resonating. 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?
Take it.
Thanks, Lachlan. I think a good way to think about it is they should be incremental and almost like steps. 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. 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, 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 eye care, and to see that come to fruition, probably more, and 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. The expectation is, Lachlan, that they're going to be pretty additive in the back half of the year.
Okay, awesome. Yeah.
Yeah. Question.
Yeah, I'll ask the question. What are you seeing in terms of co-pay requirements here? I actually used the product in September, and I'm quite lucky back at my primary. I got something from Blue Cross, so it was pretty easy to get. I did have a $0 copay. I was told by my ophthalmologist if I saw an astronomical copay, I wouldn't use the product. I was pretty glad $0 copay. I think done. What were you seeing on that use?
Yeah, no, go ahead.
So-
You forget the question.
For those not in the room, the question was essentially around reimbursement, copay. What do patients typically pay, I think is what you were asking, right, Miles?
Yes.
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's case, he got it for even less than that. It just shows the quality of the reimbursement landscape that our team has established with all the payers. The other thing, I think Miles didn't ask, but it's pretty easy to get. When you go to the doctors and they diagnose you, they see the collarettes. When you're walking out the door, essentially, you're going to get either a phone call or some sort of text message or communication, and essentially it's going to 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. It's pretty seamless and pretty affordable.
Right. What causes the disease, and what causes it to come back? Is it an environmental thing? What causes the disease, and what causes it to come back?
Oh, yeah. 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. There seems to be a higher correlation as you age. That's why we have about 45% of our patient population is Medicare as a result of that. It's just unknown as to why more people have, or some people have an over-proliferation of it.
These mites like this oily, sebaceous environment, so they really like to get into the back of the eyelashes there. Once you do 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. What typically would happen is the mites just migrate back up into the eyelashes and ultimately cause reinfestation and see the Demodex blepharitis reoccur there. Our clinical study saw about 40% of those patients saw recurrence within month six to month 12. Clinical environment tends to be the perfect place to measure these things. In real world, it's probably less. We guided to expect a retreatment rate of around 20% per year.
Could you discuss the rosacea and Lyme disease opportunities in terms of the timeframe for you to get there, the potential market, and whether there's any change of the drug itself?
Yeah, happy to. The question was, describe a little bit more about the ocular rosacea program and the Lyme program, as well as the change in the formulation. Great question. We did highlight that it's the same active ingredient. They are in different formulations. The ocular rosacea is in a sterile gel formulation. When we think about treating these diseases, we're very intentional about how we choose which formulation to do it. We knew for XDEMVY and for Demodex blepharitis, to get into the back of the eyelashes and the follicles, an eye drop is the preferred method there. We also did the similar thought on the rosacea side, having a sterile gel formulation that sits on the skin for a while allows for better penetration of the active ingredient into the eye.
We also wanted to make sure that it absorbed and didn't hamper people that wanted to wear makeup as well. That was part of the formulation considerations there. The Lyme disease is a small oral pill that you would take, and the theory here is you would take it once a month over the course of the tick season. You could think about maybe once a month for four months to cover you for the tick season. The nice thing about it is 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. That's why we have a fairly large phase II study. Then we'll also be looking at drug levels within the system as well, the PK/PD, because we knew, based on our phase II-A study, this tick kill study, that we have to get to certain levels in order to get to that 95% efficacy rate. 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, it's a 16-week course of treatment with the sterile gel. 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 two of the hallmarks of the disease. What our conversations with the agency said was, if we show improvement, we don't have to show cure, but show improvement in either of those endpoints, that could be a phase III approvable endpoint. We've developed a proprietary scale that is measuring improvements in the redness as well as the reduction in the vessels. That's the purpose of this study here. Both of those will read out in the first half of 2027.
What are those markets in their size in participants?
Yes. The market size on the ocular rosacea, there's thought to be about 15 million-17 million patients, it's a big unmet need. There's nothing out there from an FDA-approved therapeutic, the vast majority is thought to be caused by Demodex mites. Another white space opportunity that really has nothing out there to help these patients. 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, they have said that they believe it's a billion-dollar-plus opportunity. Two big potential opportunities. The nice thing about the ocular rosacea opportunity, the call point is synergistic with our XDEMVY call point, it'll be detailing those same doctors there. Very synergistic from that perspective.
Okay. That's a good transition to the pipeline.
With the ocular rosacea program, one of the things you've had to do was basically develop your own endpoint to measure these two manifestations that you want to measure. Can you maybe talk about the work you 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's essentially proprietary, there's nothing out there that's commercial off-the-shelf that we can utilize. 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 1 redness reduction, Grade 5 pronounced vessels. Spent a lot of time getting a good variety of patients to take a look at and took pictures. 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. We do internal reviews as well just to see how they're scoring compared to the clinicians at the clinical sites as well.
Very tailored approach to this because we think that's one of the key factors of success here.
I think 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 defining enrollment criteria to ensure that you're getting the right patients?
Yeah. We've taken a pretty broad approach here, but we're of course going to be noting the characteristics of the patients that enter as well. We're going to be noting the patients, whether they have collarettes and whether they have Demodex blepharitis. That'll be one of the key things that we'll be taking a look at. From an inclusion/exclusion criteria, they can't be taking steroids or anything else that could be treating the rosacea as well. Those are the key exclusion criteria.
Okay. I know you did a phase II-A study in papulopustular rosacea.
That's right.
Similar, maybe not quite the same.
Yeah.
How should we think about the read-through from that? Maybe what is similar and what differs as you move to technically maybe a different disease, different manifestation for the skin?
No, that helps us as we thought about developing this clinical study. This PPR study is a type of rosacea that's actually caused by mites as well, and we showed a phase II-A study that showed a clinically meaningful reduction and significantly meaningful reduction in the redness as well as the pustules. We also showed that through skin samples, that we were killing the mites as well. We think that gives a nice read-through in terms of this ocular rosacea program. While they don't have the pustules, they do have the redness, that went into our thinking on the powering side of things, also how to think about the formulation as well, too. Those give us better confidence on the potential outcome here.
Okay. You touched on formulation. Maybe what's changed from that formulation, and have you done testing to see how much lotilaner still gets into the skin?
We do test to see 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 in the patients that maybe have rosacea. We've reduced the number of excipients there. Those were the key things that really went into the thinking on the gel formulation.
Okay. Awesome. On TP-05, 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.
Yeah.
You're always worried about the ticks. 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. 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.
Right.
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?
Right
Show trends that you were impacting infection rates?
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 an 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 multiple years to enroll and then, of course, go through the regulatory pathway.
This is one of the initiatives that the agency's trying to put forth, is taking a look at some of these biomarkers and testing them out and seeing if there is an approach in which you can take a biomarker approach or 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. We're taking some of these biomarkers that are being explored and using them as exploratory at this point.
Okay. Yeah. I certainly feel like I see a headline about Lyme disease more or less every day now.
It seems like it.
We're coming into the season.
Yeah.
Yeah. On the topic of accelerated development, sounds like that's obviously still pretty early, the LymeX program 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? Are they doing work to validate biomarkers or something, or is it still more the ideation phase?
I think it's early days at this point. I think the LymeX initiative got kicked off a couple months ago, I think it's more in the ideation phase, they're really wanting to move forward as quickly as they can on trying to develop something and get it on market. That said, we are having conversations with the agency and various other government affairs perspectives, too, just highlighting the importance of getting treatment for these patients. We're having multiple dialogues as this goes on. We have some time in which to have these conversations and maybe have a different outcome prior to partnering this ahead of a phase III study. This is something that could be helpful as you think about a partnering pathway as well.
Awesome. I realize we're over time, so I will leave it there. If anybody has further Q&A, we have a breakout session in Burnham B starting in 10 minutes.