Going here with our next company presenter at the B of A annual healthcare conference. Pleased to be introducing Tarsus Pharmaceuticals. Bobby Azamian, Chief Executive Officer, and Jeff Farrow, CFO. So, gentlemen, thanks for joining us at the conference. And, I guess, you know, hot off of the 1Q update. For those less familiar, you know, you guys were launching XDEMVY for treatment of Demodex blepharitis, a new ophthalmology category. So, you know, maybe the initial impressions of how the launch is going relative to expectation, and we could start there and then jump into more specific questions.
That's great, Jason. Thanks for having me and Jeff here. It's a pleasure to be here. Now two full quarters into our launch. So we're, as Jason said, creating a new category of medicine, and we're bringing that to eye care. So we're treating a condition called Demodex blepharitis with our drug XDEMVY. And we're really pleased with how the launch is going. So we just announced our first quarter results last week. And I'm really proud that, you know, category creation as a small company is going really, really well. We've really been diligent about serving the patient, serving the doctor, and serving the payer. And we have a drug that has a very strong value proposition for each of those stakeholders. So $24.7 million in sales in Q1. A really strong trajectory: 90% increased revenue from Q4 and 26,000 patients served.
Over 8,000 doctors, over 8,000 eye care providers, optometrists and ophthalmologists, now having experience with XDEMVY. Over half of those having multiple prescriptions. A strong continued gross-to-net discount of 55%. So just really, really pleased with the second quarter of our launch, and we're looking forward to more good things to come.
What do you see as, you know, I guess the obvious would be you're building a new category and you got to create awareness, you got to drive a paradigm shift. But, like, the unique hurdles that you face, and then maybe the tailwinds that you see as reimbursement comes online and some of this heavy lifting occurs in the first kind of, call it, year of the launch and then, you know, as we look ahead to 25+ .
Yeah. No, I mean, we're mindful that this is going to take time. We're building a new category. We're serving more and more doctors. So in terms of tailwinds and headwinds, you know, I think of it as we've got a lot more patients to serve and we're just getting started with a number of these doctors. I'm in the field a lot.
Yeah.
So I see that firsthand. I see that, you know, doctors that have had experience for a few months, they're prescribing more and more. They're getting to more and more patients that might not be, you know, raging Demodex blepharitis coming in the door, but still are suffering and still have collarettes. And, I also see that as access gets better, that gets easier for doctors that, don't have experience yet. So I think of it as we've got segments of patients to serve. We've got 7 million patients that are presenting to eye care clinics with Demodex blepharitis. There's 1.5 million of those that are already diagnosed. We are serving patients today, vast majority in those 1.5 million. So we've got a lot more segments to serve.
And then as we get more and more doctors educated and as access gets better and better, we expect that to be more, more downhill sledding. So what we anticipate is really steady growth quarter-over-quarter from here, and really demonstrating the blockbuster potential of XDEMVY.
Yep. Now maybe, one of the big challenges, I think, with forecasting the peak revenue opportunity is getting a handle on the prevalence in the epidemiology, right? You know, in terms of the number of patients out there, it could be substantial versus your best understanding of where we are with patients and how you define the top of the funnel, right? So, you know, maybe if you can help frame where your current understanding of things are and the work you're doing to better understand and communicate that to investors so that you can, you know, give investors a better handle on that.
Yeah. No, thanks, Jason. We, we think there's about 25 million patients in the United States impacted by Demodex blepharitis. We're really focused on about 7 million at this stage. And what we consider to be the immediate target is the 1.5 million patients that have been diagnosed and seeking treatment for DB. These folks, you know, are actively going into the office and seeking treatment. They, before XDEMVY came along, they really didn't have an efficacious therapy. It was tea tree oil, lid wipes, which resulted in them coming back more frequently into the office and sometimes being off-label prescribed, dry eyes, which again isn't efficacious. So that's the obvious, you know, area that we're focused on now and seeing the biggest penetration. But we also see dry eye as being a potential opportunity for us.
We know that there's patients that have DB that are, you know, also seeing dry eye indications. The other two areas that we're focused on are contact lenses. There's a lot of folks that can't tolerate contact lens wearing or can only wear it for a fraction of the time that they should be able to use it. And then finally, cataract patients. We know that a lot of these patients that are coming in for cataract surgery have the collarettes, have these symptoms of DB. So with a better potential therapy prior to cataract surgery, you might get a better outcome following the cataract surgery. So those are the initial areas that we're focused on. You know, we do think that 1.5 million patients that have DB is probably going to expand now that there are therapies out there right now.
But that's been our biggest area of penetration today.
Okay. And from a market creation or building exercise perspective, talk about how you sequence. It sounds like maybe the physician and expanding the prescriber base is sort of that next push. And then, utilizing DTC, social media, whatever, to pull through patients, at some point once the clinician is brought on board and acclimated and, you know, has an operating history, so to speak, of prescribing this so that they're not getting inundated with patients requesting the drug, but maybe they're resistant to it. Is that, is that how that evolves over time?
That's right. Very simply, in that cadence and sequencing, it's doctor, payer, patient. So we actually started two years before launch educating doctors. And that's really paid off with momentum out of the gates. And we have 8,000 that have had direct prescribing experience, direct experience with their patients experiencing XDEMVY. And that starts to feed back positively as they get those patients coming back. They look for more patients, as Jeff said. The payer side is so critical to get, you know, access at affordable costs for patients throughout the country. We've been very pleased with our progress there. We had 18 million lives from two major payers on preferred status that came on board recently. And that 55% gross-to-net really tells that story positively.
I think what you're getting at is how do we actually expand that reach within the physician targets we have, and how do we actually drive patients to the clinic? So we actually have two initiatives that we're sequencing later this year. We are recruiting the next wave of sales reps. That'll be about a 50% expansion of sales force that'll come online in the field by the end of Q3. Then to your point, we also have some direct-to-patient campaigns that are kicking off. We have a Mite Party campaign. Mite Party is the one party you don't want to be invited to, right? Mite's having a party literally on your eyelids. That's resonating. That's just about a month live at this point.
We are considering more significant investments in direct-to-consumer marketing after the expansion of the sales force as we have coverage really fully on board.
Yep. Okay. And how does the Part D coverage come online? You know, does it, is it all at the start of the year? Does it stagger between different Part D chunks of plans? How could you maybe frame that?
Yeah. No, so there's typically a formulary review that happens in the springtime. And we'll get a readout of that formulary review probably September, October timeframe. But the impact will really start in January of 2025. But to your point, it'll take time for that. It's not a light switch. It's a pull-through. So we'll probably see the broad coverage by middle of 2025. And at that point, we expect to be at that sort of steady state of gross-to-net of about 50%.
Right. And to that point around gross-to-net, I guess some could look at that as high for an uncompetitive category. There are no FDA-approved alternatives. You know, what I guess why so conservative on the gross-to-net ultimately is the question?
Yeah. Yeah. No, it's a good question. And I asked it day one of my joining Tarsus as well because, you know, I've come from the rare disease space .
That's right at gross-to-net.
Right. Exactly. There was no rebate, right? It's just different. The eye care space, you know, there's an expectation of the payers that there is going to be a heavy discount. I mean, to put it in context, you know, the dry eye drugs are typically a gross-to-net discount of around 80%. So we're significantly better than that. But, you know, fundamentally, you know, despite the competition and some of the other aspects of, of our drug, there's just an expectation of a higher gross-to-net discount. And that is, you know, we're not curing blindness. We're not, you know, prolonging life. So there's that sort of pushback that we get from the payers.
Yeah. And I heard it. I mean, I was here actually two weeks ago, the same hotel for a Asembia big payer conference. And our head of market access, you know, really is so well connected there. And you see it in the conversations, right? I mean, okay, why should we cover this? Well, it's the only drug. How much is it going to cost? Well, it's one course. And you'll probably save money on some of the other medicines that the patients are taking that they don't need to. And I think with that approach, we can really drive the best deals with payers. And that's why we talk about gross-to-net rather than covered lives because we want to get coverage in the vast majority of cases, but there may be some instances where non-contracted coverage just is good.
So we're really looking payer by payer and really trying to get access for patients throughout the country.
So given how expansive some of the epidemiology, you know, numbers are, analysts are very forced to kind of focus on the script trends, right? And so you talked about sort of seeing a similar, I guess, absolute TRX or bottles add in 1Q, as you saw, I'm sorry, in 2Q, as you saw in 4Q. But we've been 5 weeks through now, and we saw, like, really good print last Friday on TRX. And it seems mathematically a little challenging to get to only 10,000 bottles adds. So, I don't know. I guess the question is, like, what do you know about the next 7 weeks that maybe is kind of implied in that guidance, or are you just trying to be conservative?
No, I think we take a very sort of mathematical, model approach to, to our guidance. And we look at potentially holidays. We take a look at conferences, you know, that could pull the doctors out and not able to write the script.
As more are they coming and.
Exactly. And so that's some of the calculus that we go through there. But, I mean, to your point, we gave a bottle growth of, you know, about 10,000 over what we landed at in Q2 of 25,000. I think the important thing to keep in mind there is that's not inclusive of refills, right? So that is new scripts. So yeah, no, we think that's appropriate guidance. And we take a very systematic approach to that.
It seems like the relationship to bottles and TRXs have kind of shown some consistency of trend. Do you feel like we're at a point now where it's no longer the Wild West looking at scripts every week or so and having some comfort around the reliability of that as a data trend point?
Yeah, I think it's better to take a look at it over a month trend. You know, week to week, there could be some significant fluctuations. You know, it could be up 15% and then the following week down 10% in terms of inaccuracy. So better to take an aggregate of four weeks and take a look at the trend. It's consistently moving upward, which is what we want to see.
Yeah. Maybe just as you guys think about retreatment, it's obviously too early to talk about retreatment, but it would be more of a thing that patients treated now in 2025, 2026 maybe, start to come back into the treatment system. Have you, how do you characterize that dynamic? Any analogs, things that you might point investors to?
Yeah. I think the best guide is the data. In our Saturn-1 phase III study, we saw that by a year, about 40% of patients had recurred. And the biology actually makes sense. We have mites throughout our body. We're getting an eradication of the eyelids, but patients are at risk of having that infestation. And so the mites are going to find the eyelids over time. So what we expect is in about a year, 40% plus patients will be retreated. And with the volumes we're seeing in Q1, we expect that in 2025, we'll start to see some of those retreatments. And then we'll get a sense for really what that looks like in the real world. But we're thinking maybe it's 20%-30% of patients will be retreated over the course of approximately a year.
I'm sorry. So if you're treated, today, you know, in a year to two years' time, there's a 20%-30% of those would have a retreatment like a year, a year or a year and a half later?
That's a good way to think about it. Yeah.
Okay. And then can you just talk a little bit about the, the increase in selling and marketing investment here? How much of that will go to DTC? What mediums will that be exactly?
Yeah. No, so we haven't kicked off that process. We're doing the planning as we speak. It probably wouldn't hit until the fourth quarter, assuming we hit the metrics that Bobby referred to in terms of, you know, the number of reps, the touchpoints, and payer coverage. But, you know, a typical Hulu streaming TV ad, you know, would, that would maybe run for a couple quarters was anywhere from $10 million-$15 million. So if you think about modeling that, you know, happening in the fourth quarter, rolling over into the first quarter is a good way to sort of think about that.
Is this pulse or is this table stakes to being in the space and driving like a blockbuster brand? You're just going to have an annual investment in the DTC side?
Yeah, I think if we see a great return on an investment here, it's probably some sort of annual spend that we'll see there. So, yeah. So we're really using this DTC program to see if we want to go broader into network. So we want to make sure we get it right before we make that decision there.
All right. Well, we're at time here. So thank you, gentlemen, for joining us. And hopefully, you have a good rest of your conference.
Thank you, Jason. Appreciate the opportunity. Much more to come with our pipeline too. We're happy to talk about that in the future.
Great. All right, guys.
Thank you.