Tarsus Pharmaceuticals, Inc. ($TARS)

All right. I think we're ready to get started. Good afternoon, everyone. Welcome to the Barclays Miami Healthcare Conference. I'm Jenna Davidner. I'm one of the analysts here on the specialty pharmaceuticals team and very pleased to have Tarsus Pharmaceuticals on the stage with me this afternoon. From the company, we have Jeff Farrow, the CFO; and Dave Nakasone, who is the Head of Investor Relations. Thank you both for taking the time.

Well, thank you, Jenna. It's great to be here.

So just to level set the conversation, the company is a couple of years into the launch of XDEMVY. So maybe for people that are newer to the story, can you give us an overview of Tarsus and maybe talk about the time line of when XDEMVY was approved and launched, and I'm going to get into a couple of questions about the product itself and the condition and things like that.

Sure, happy to. So Tarsus Pharmaceuticals is a biopharmaceutical company that is headquartered in Southern California in Irvine, California. And we are a commercial company, as I mentioned, that has a product on the market called XDEMVY for the treatment of demodex blepharitis. It's a disease of the eye that is caused by over-proliferation of these demodex mites, and we kill the demodex mites very efficaciously with XDEMVY. We got approval in August of '23. So this is really our -- start of our third year of launch. Last year, we recorded revenues of about $450 million and treated about 500,000 patients out of the 9 million sort of available market to us. That -- these are patients that are actively going in and seeking eye care professional assistance. Overlaying that, there's actually 25 million patients that are impacted by demodex blepharitis. So it's a highly prevalent disease. This year, we provided guidance -- the annual guidance for the first time, and we guided to top line revenue of between $690 million and $700 million. And from long-term perspective, we think the peak guidance is around $2 billion in ultimate profitability or off of top line revenue. And then we also have a couple of products in the pipeline as well. We've initiated 2 Phase II studies, the first one using the same active ingredient that's in XDEMVY, except in the sterile topical gel for the treatment of ocular rosacea. And then in an oral tablet, the same active ingredient for the prophylactic prevention of Lyme disease. It's another exciting program that we're going to be kicking off here shortly as well.

Awesome. Thank you for that great overview. So what's interesting is you mentioned how broad the DB market opportunity is. And I remember from around the time of the launch, some of the pushback. People weren't really familiar because there is no -- there was no FDA-approved product to treat this. And if you just think about that in combination with how strong your launch has been in this revenue trajectory in the first 2 full years. Maybe can you talk about things like the diagnostic process and maybe from the 25 million, how do you think about what your more near long-term addressable patient population is within that. And just anything, the launch has gone -- has exceeded expectations on everything from volume growth to also gross-to-net. So maybe just in the context of the first 2 years. putting together all of those before we get into the 2026 outlook and the peak sales and longer-term trajectory?

Sure. Yes. We like to think of ourselves as being a category-creating organization, and we've really created a new category here that nobody had ever heard of demodex blepharitis before and even the doctors weren't very familiar with it. And so the treatment paradigm before was patients would come in complaining about itchy, red, burning eyes. And the only therapies that were available at the time were sort of these homeopathic therapies, including tea tree oil, which causes stinging and burning or these lid scrubs kind of basically wipe off the scruff, neither voice got to the root cause of the disease, which is the demodex mites. And so the founder and CEO, Bobby Azamian was the one that identified this as a potential therapeutic area and took it through clinical development. And as part of that clinical development pathway, it was really getting out there and educating the eye care physicians on this is really a disease that is caused by these demodex mites. And if you kill the mites then you can cure the disease. And so through that clinical process, the education paradigm was going forward. The team did a really nice job on the payer side, the market access group of going out there, educating the payers on this huge unmet need and the fact that there's a lot of off-label usage of products like dry eye that they're paying for that aren't benefiting the patients. So if you had a product that could be a 6-month or 6-week treatment period and cured the disease for a period of time, that made sense for them to cover that. And so we were able to get really broad payer coverage ultimately, now we're at 90% prior payer coverage. That evolved over time, when we got out of the gate, it was initially commercial coverage that came online over time. And the gross to nets were somewhat higher than they are now as a result of that because we're covering a lot more of the patients with free goods or co-pay assistance. And then in 2025, the start of 2025, we had Medicare come online. And so that was really a helpful tailwind for 2025 as well. So that helped us really evolve the gross to net, kind of where we're at steady state, we exited Q4 at a gross to net discount of about 44%. And we expect the long-term gross to net sort of in the 43% to 45% range. Absent the Q1 dynamics where the deductibles typically reset. There's usually more payers assist or co-pay assistance in other programs that we might implement. So it's going to be slightly higher in Q1, but it will evolve over time.

Awesome, and it's just kind of fascinating to think of even doctors being less familiar with DB at the start of your launch and approval. And in year 2, you're nearing $500 million. Year 3, you're approaching $700 million. It just really speaks to how prevalent this condition is and how well the drug worked. Then on top of that, you have a very strong commercial team within Tarsus that's done a great job. So I wanted to focus on that because it's played a huge role in the launch. So maybe from the beginning, can you talk about the sales infrastructure you started with? And along the way, what has -- where have you added? And maybe where do we stand currently?

Yes. Thanks, Jenna. So we started with about 100-person sales force, and it was really targeted. And about a year into the launch, we added about 50% more. And we knew the size of the market or roughly 15,000 prescribing eye care professionals, half of them being optometrists and half of being ophthalmologists. And to your earlier point, we really saw the sales starting to take off. Most recently and earlier this year, we announced that we're adding about 15 to 20 key account leaders. And the expectation here is they're going to be input into the highest producing territories. These are the best of the best that we have and really going to expand and drive depth amongst our current prescribers.

And since you brought up the prescriber base, it's interesting how it's very targeted. There's -- maybe you can talk about the group that you're targeting and why? How many of them are currently prescribing and maybe how you think about the frequency of these prescribers and maybe increasing that utilization over time?

So we have about, I'd say a little over 20,000 who are prescribing today, prescribing XDEMVY today, but about 15,000 represent about 85% of all prescriptions in the eye. And like I said earlier, half are optometrists and half are ophthalmologists. And so when you look at that landscape, we have about 40% who are writing weekly. And then our daily prescribers are those that write 5 or more per week has grown 20% since the last quarter. So our focus is on that core audience of prescribers and really driving depth of utilization in the practice. So providing them with evidence, providing them with further education. It's a segue into the direct-to-consumer advertising as well to help drive even more patients. But ideally, we want to get as many of those 15,000 to write weekly and eventually daily.

Yes, interesting because we've talked to some eye care professionals that are writing daily and they tell us we see these patients all the time. So it just -- with the 40% you mentioned and the very well-known target population. It's just there's still such a way to keep increasing the utilization within the group you already have your touch points with and you also mentioned DTC. So I wanted to go there next. And I don't know in the audience who else has seen the commercial, but it's a great commercial and it's very motivating, next time you go to the eye doctor to have them check and look down in slit lamp. So can you talk about the DTC campaign, when you kick that off and maybe what impact if or what impact it might be having now or could in the future, just given maybe more of a delayed response as you target the consumers and they kind of fall through the funnel?

Yes. No, I'll start and Dave, feel free to chime in. But it is a very impactful commercial. And one of the byproducts of it is actually sort of destigmatized the fact that people -- one of the challenges that doctors had at one point was like how do you bring it up to patients that they've got mites in their eyes without freaking them out. And so this helps sort of destigmatize it a little bit, but it's been very impactful, and we started the program last year. And we've -- it's a combination of the streaming TV, where you can get very targeted, very good data. Actually, when a commercial airs to when the patient picks it up. It's scary how much information you could actually garner from those smart TVs. And then the network TV, we initiated shortly thereafter and there's more eyeballs on the ad there, but it's a little bit less targeted there, but it helps us have a broad reach between sort of the commercial consumer as well as the older Medicare patients as well by sort of having those different targets. And so we learned a lot last year. We're going to spend the same amount this year in 2026. But we -- because of the learnings we had, we know which programs seem to resonate and drive the most utilization and what time slots. And so we're able to target it more -- even more efficiently. So those dollars have even a greater ROI. And this is sort of an aggregate type of thing. The more you have it out there with a good commercial, the more impact it has. And so we've already surpassed our cost to do this commercial and it's continuing to grow, and we're looking at a multiple on return at this point.

Awesome. And maybe can we also just differentiate between the 25 million TAM, the 9 million? Because then when we tie the DTC, I think it's -- the 25 million patients is a massive opportunity. So having more of them fall into that more realistic or addressable near-term population? Just can you break those and give the difference for investors?

Yes. So Jenna, the 9 million are essentially those that are immediately addressable. They're either diagnosed already with demodex blepharitis or they're coming in for a complementary condition. Dry eye, Meibomian gland disease, contact lens intolerance, or they're coming in for cataract procedures. And so essentially about 60% of everybody walking through the eye doctor probably has demodex blepharitis. So that's how you get to that 9 million and DTC is really helping to drive those above the 9 or essentially not 25 million and helping to grow the addressable market. Because patients are coming in, asking for XDEMVY by name or asking the doctor to check for collarettes and we see this also in our unaided awareness. So before we started the campaign, I'm sure like many of you, you probably never heard of demodex blepharitis. Now we have essentially 1 in 4 patients coming into the doctor's office and asking for it by name.

Awesome. And so we talked about the launch trajectory today. We talked a lot about the commercial. So now let's focus a little bit on guidance, which Jeff, you mentioned in the beginning. So very strong 50% plus growth expected this year. You're investing. Still potential for positive EBITDA. So can you just help us understand what gives you the most confidence in that outlook for this year and maybe refresh us on the spending outlook and maybe what some of the drivers are on that side?

Sure. Yes. So we -- our philosophy on guidance has always been, we're not going to give guidance until we can give good guidance. And as you highlighted, there really wasn't a good analog out there before Tarsus came along. And so there was nothing we could sort of say, well, let's take a look at this launch trajectory. So we wanted to get some history. And now we have about 2 years of historical data that we can draw upon. And that includes kind of where we exited in the fourth quarter on scripts. We -- now we have a stable payer base now. So we know what the gross to nets are within patient mixes. We have a good sense of the seasonality. So there's no seasonality of the disease, but we do know since we're primarily an NRx product or a new script product as opposed to a chronic disease that gets refills. Whenever there's a doctor not in the office, we see a drop in scripts. Usually recovers subsequent to the doctor coming back. But whenever there's a vacation or a big conference or bad weather, we'll see a drop in the scripts as a result of that. So based on that, we made some assumptions on either sort of out of offices, gross to net assumptions and continued growth as it relates to our DTC campaign that got us to the $670 million to $700 million in range there. So we feel really good about where we're going to land, and that's basically how we came up with the assumptions there.

Perfect. And then just to double click on the cadence question. Can you just remind us, obviously, you were pretty explicit about 1Q. But then can you remind us of which quarters kind of maybe step up or down through the rest of the year?

Sure. Yes. So over the last 2 years, we've seen a familiar pattern. And we've looked at this and other companies in the eye care space, too. So it's not really isolated just to Tarsus. But if you look at the NRx pattern on some of these other eye care, you'll see the same thing. So in Q1, you'll typically see patients deferring doctor visits because they have their deductibles reset. And so they'll usually come back at a later stage once they've kind of gotten through those deductibles. We'll also see some erosion on the gross to net discount, which we talked about. It usually will come down a couple of points as a result of deductibles resetting us providing more co-pay assistance. So we'll see a drop in scripts as well as maybe an impact of the top line revenue because of the gross to net impact. And then in Q2, we'll see a nice ramp up again in growth. So in the summertime in the third quarter, we'll see a little bit of a tempering of growth. We'll continue to see growth, but it will be not at the same pace as between Q1 and Q2. And -- and then over the last couple of years, we've seen a nice rocket ship in the fourth quarter where patients have gotten through their deductible. They want to use up their FSAs. And so that tends to be our best quarter, quite frankly.

Awesome. Okay. So let's shift gears a little bit into your peak sales and total opportunity here. I think in the beginning, as we've touched on multiple times. This opportunity was maybe a little bit underappreciated or misunderstood. And then you've done so well with this launch trajectory approaching $700 million in just year 3. So sometimes what we hear a little bit of pushback on is the overall runway in this product, just given how big it already is, and we're still very early. And I think you also mentioned this in the beginning, but just remind us really how early we are in terms of the patients that you've treated to date and it helps people also frame, you're generating over $1,000 per script. And so I think sometimes that gets a little bit lost in translation as well. And then after, we'll get into the numbers on the peak sales.

Yes. So I think one of the most profound stats is launch to date, we've treated about 500,000 patients, and it's a really great start. And -- but that's what it is. There's still 25 million out there that we're looking to serve. So when you think about how much runway there really is, there's a long way to go. And when we talk to ECPs, nobody said they've reached their limits. They're not even close. And you see it on the podiums. You see it in medical meetings. You see it in field rides. And so for us, it's really about driving on that message. You really -- you need to have every patient look down in the slit lamp because there's a really good chance they have demodex blepharitis.

So now focusing on the numbers. At the time of launch, the peak sales was $1 billion plus. You recently just doubled that to $2 billion plus. I mean, what gives -- what gave you the confidence to increase that peak sales estimate. And I would just love to hear your thoughts on that.

Yes. We've been -- we knew it's been tracking higher, and the launch has even exceeded our high expectations nice to see. But it's been sort of multifactorial. But one of the things that we have seen is doctors even better than what we saw in the clinical study are saying, this is helping all my patients, right? And there's a lot of doctor talk within this community, the eye care community in terms of have you heard about XDEMVY? Oh, yes, it's been great. So that's been super helpful. And as Dave highlighted, these doctors are -- most written prescribers say they have still tons of more patients that they could write for. So big unmet opportunity there. And then the DTC, the activation of the consumers has been really impactful. We see that this has been something that really resonates in the consumer side. And so that's been driving in patients that we weren't really initially modeling for. So it's -- and the trajectory of the launch is a little bit steeper than what we anticipated. So all of those things and the fact that we're just sort of scratching the surface on the opportunity here make us think that the $2 billion is an achievable number.

Awesome. And then even beyond that, as we think about the pipeline, you have 2 programs in development. So maybe as we're starting to run out of time here, can you touch on these programs, what the opportunity is and maybe what the next catalysts are for those?

Yes. So we're really excited about these programs. It's all sort of cliched, but it's a pipeline in a product, all the same active ingredient. So ocular rosacea is probably the nearest term one. So this is a type of rosacea that's around the orbital eye area, that KOLs tell us they see this all the time. It's much more awareness out there than, say, demodex blepharitis at the same time. And what we are doing is we've built a sterile gel formulation of the same active ingredient that's in XDEMVY and we know XDEMVY is very good at killing the mites. And so the theory here is this ocular rosacea is about 15 million to 18 million patients. It's caused by demodex mites by the most part. So if we can kill the mites, we should see a reduction in the rosacea or the redness. But there's also another hallmark of the disease, which is this pronounced vessels on the eyelids. And so what we're doing is designed to study that could show a reduction in the redness or a reduction in the vessels based on the FDA discussion. Either of those would be valid endpoints for a pivotal study. And so we've kicked that study off here in December, and we'll have top line readout in the first half of next year. And then Lyme disease, you want to touch on Lyme disease?

Yes. So we're excited to get the Phase II study for Lyme disease prevention. It's an oral tablet. It is probably going to be about 700 patients. We plan to enroll it in 1 tick season. And it's a pretty -- as many of you folks know, Lyme disease is a pretty prevalent disease. It costs the U.S. health care system well over $1 billion. And we should have data similar to ocular rosacea in the first half of next year.

Awesome. And just to wrap things up. And I also wanted to make a comment on your balance sheet, which I think is underappreciated. This is a newer launch company. You have a very strong balance sheet with over $400 million in cash and equivalents, very little debt, and you're on the cusp of profitability. And as I mentioned, these scripts generate over $1,000 per script, it just feels like you have such high financial flexibility here and just a very strong operating model and future outlook. So with those things in mind, and with the way the launch trajectory has gone with the new peak sales, the 2026 guidance and your new peak sales, which is double what you had before. Help us in your mind, what do you think is the most dislocated in terms of maybe how the stock has responded and we've talked about this throughout the year. People follow the weekly script trends and you have been very clear about 1Q seasonality, just all of that mumbo jumbo that I just said. Like maybe put into context for people what you think is the most underappreciated right now.

I think you highlighted it in terms of the opportunity here in XDEMVY itself, right? I think there's been always a skepticism, nobody heard about this disease. We've demonstrated a strong launch, but people focus on the weekly scripts, despite us telling them that there's going to be weakness. We told people that Q1 is going to be flat to down, right? But nevertheless, people are sort of reacting to some of the decrease in IQVIA scripts there. So I -- we view this as a buying opportunity, knowing that we've given very strong guidance from $650 million to $700 million. So I think that's one of the big misses here is just listen to the guidance, take a look at the big opportunity that we're just scratching the surface here. And that this is a big multibillion dollar opportunity.

Awesome. And hopefully, with having the full year guidance out, it helps provide an anchor for people to maybe not need to focus as much on those weekly scripts. But thank you guys so much for attending the conference and congratulations on a great launch so far.

Thank you, Jenna. It's great to be here.

Thank you, Jenna.