Tarsus Pharmaceuticals, Inc. (TARS)
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Guggenheim 5th Annual Healthy Altitudes Summit

Mar 13, 2024

Eddie Hickman
Biotech Analyst, Guggenheim Partners

Good morning, everyone. My name is Eddie Hickman. I'm one of the biotech analysts here, and I'm joined this morning by Bobby Azamian, CEO of Tarsus Pharmaceuticals. Bobby, thanks again for joining us here. Maybe before we get started with questions, do you want to introduce yourself and maybe give us a background of Tarsus leading up to the approval of your first drug last year?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Sure, and it's great to be back here. Been a very eventful year. Many of you have met my eight-month-old son. And, we now have a first medicine at Tarsus that we've launched, so, thanks for having me back here. A lot, a lot going on. Tarsus is a company that is devoted to category creation. So this is not easy, but when it works out, it's very rewarding. Basically, we're pioneering new medicines for diseases that have not had medicines before. And our lead medicine, XDEMVY, was approved about six months ago. It is for the treatment of Demodex blepharitis, a condition affecting 25 million Americans. Blepharitis is something we've known about for a long time, but there's never been a drug until ours. We also have a pipeline, that just read out three phase II trials positively, each of which is a category-creating medicine.

I'm really proud of our start to our launch. It's really exceeded our own expectations. And we think about the stakeholders we're serving: patients, doctors, and payers. And we've found that by creating a new category, we have the chance to actually really serve and accelerate a launch in each of those dimensions. We had over 17,500 bottles dispensed in the fourth quarter last year, so a very strong start. Obviously, there's millions of patients to serve here. We had over 6,000 eye care provider doctors have experience with the medicine. And that's out of our target core audience of about 15,000 eye care providers. And then we had a gross net discount of 58%, which is well ahead, I think, of what we had projected. And you know, we have a fair and reasonable value for our drug because it's a six-week dose that really has lasting effects.

So in each of those dimensions, patient, doctor, and payer, we feel like we're off to a very strong start. We are planning to do some things to shift the curve left and really find the peak of this product. I think that's not yet clear. There are millions of patients. We think it's a multi-billion-dollar market opportunity. We are going to do some things to really have doctors get educated more quickly, get more rapid experience with the drug. We're certainly seeing that once a doctor has experience with a medicine, they start raving about it and they start prescribing it more and more. Our pipeline also, we're thoughtfully advancing beyond those positive phase II readouts, and that's in eye care, dermatology, and Lyme prevention, each really, I think, underserved markets where we think we can lead.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

Great, thanks for that. So starting with XDEMVY, obviously, strong, strong launch above expectations. And there's sort of two parts of that: the volume in terms of the prescription growth, but also on the gross net discount that you spoke about, which was sort of better than many expected. So starting with the volume aspect, you talked about 25 million potential patients, but you've also sort of quoted at 1.5 sort of diagnosed patients. How well have you penetrated that market, and how much more sort of within that known market of patients, do you have to go before you sort of can expand beyond into that sort of other sort of 20 million plus?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Yeah, we think about the market just as you said. So there are 1.5 million patients that are already diagnosed with Demodex blepharitis, and they're getting over-the-counter therapies that are poorly effective. And so that's where we've seen the majority, of the traction early on. It's easy for doctors to say, you know, I had these patients that have been suffering, let me convert them from Tetral or lid wipes to XDEMVY. We're not seeing as much of that after the first month or so. We're seeing that, sure, patients are coming in complaining of itching, burning, redness. Those are the hallmarks of this disease: crusting, and they may not have been diagnosed yet, but they're coming in complaining. So my mom's one of these patients, actually. She tried Tetral before XDEMVY was approved. That didn't work out for her so well.

Then she got XDEMVY, but she actually presented with a common thing, a stye, a red inflamed nodule in the eye. The eye doctor looked at her eyelids, saw that she had the pathognomonic sign. We actually have a precision medicine. There's a pathognomonic sign called collarettes that, when you have that, you know you have Demodex blepharitis. And then her doctor put her on XDEMVY. So we're hearing and seeing lots of cases like that, not necessarily, you know, stably diagnosed, but now coming in with complaints and getting diagnosed. And then I think where we want to move is toward patients who have comorbid conditions but also have Demodex blepharitis. And we know there are seven million patients already in the eye care provider offices with those conditions. Those are dry eye.

So a lot of patients are on dry medicines that probably have collarettes and should be on XDEMVY. That's patients presenting for cataract surgery, and that's patients with contact lens intolerance like me, a contact lens wearer that, you know, can't stand their lenses all day. And what we plan to do is generate evidence in those segments to really drive adoption. But to, you know, to answer your question, Eddie, we are starting to see some doctors using this in their pre-cataract patient population or looking at their patients that are coming in with dry eye and starting to see that they have collarettes. So that's where the power, I think, of a doctor having five or 10 prescriptions; they really start saying, wow, look at the results I'm seeing. Patient looks better. They feel better.

Let me see how I can serve other patients in my clinic. So that's where we're going.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

So you talk about the 6,000 sort of physicians that you've targeted, and I think you've said about half of them have written only one script, and then, you know, the only a couple more have written sort of two or more. Is there sort of a bolus or a sort of concentration of doctors that are writing this? And if so, like, is there pushback? What is the education that's needed among doctors that haven't yet adopted? And what are you sort of hearing that you need to do sort of education-wise with your salesforce to sort of increase that number and penetration?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Yeah. So let me let me unpack that a little bit. I mean, first off, we're really pleased with the 6,000 doctors that are prescribed. That's well ahead of our schedule. There's 15,000 we're serving. We have an 85 rep salesforce. So they're hustling, and they're really getting to these doctors. To your point, there's certainly early adopters, middle adopters, and later adopters. And we see that physician journey unfolding. We now see that it takes a few visits to get a doctor prescribing XDEMVY because they need to understand, okay, why should I look at the lids? What do I see when I look at the lids? There's this type of debris. Okay, let me go back and do that. And then the rep comes back and says, did you look for patients? What did you see? And then after a few visits, they try one.

And then we see after they try one, they try five or 10. And once they get to that point, they become champions. So that's the type of adoption that we want to drive with our salesforce. Now, to your point, once we get beyond 6,000 and even within that 6,000, we want to increase depth and ultimately breadth. And so what we see is, only half of those 6,000 prescribe more than one. And there are some that have prescribed 20 a week, candidly. I mean, half the patients in an eye care clinic have this disease, and they're suffering in different ways. So one of the things we do plan to do later this year is expand our salesforce, about 50%.

We think that'll allow us to primarily increase frequency and increase that depth of prescribing amongst the 6,000 and also over time help us reach the broader audience.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

When we're thinking about sort of volume of script inflection, when do you think that increased salesforce would sort of, you know, come to fruition when we look at sort of you the expected inflection, or do you just expect that sort of ramp to continue or to increase?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

We expect steady, consistent growth. I mean, this is category creation. And certainly the product seems to be even better than we thought in the real world. We're hearing those stories from doctors. They're starting to share their experiences, their images. We've certainly seen that at recent conferences in ophthalmology and optometry. So that tone has changed. But I see steady, consistent growth, and I think expanding the salesforce would really help continue that. When we talk about, you know, shifting that curve left and finding the peak, it's really about driving adoption first and foremost within the existing prescribers. So, you know, it's not easy to penetrate a market of millions of patients where no one has done it before. So that's where we see the utility of expanding the salesforce.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

Last question on the script part. You know, this is a trackable launch on IQVIA, at least not Symphony. You know, can you comment on sort of the accuracy of that and if you were impacted at all by the sort of recent, you know, Cardinal Health hack at all and sort of how should we think about going forward, whether we should, you know, how accurately we can track the launch using those public measures?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Yeah. So, there are third parties that track our scripts. That's because we have a medicine that's serving millions of patients. We have four pharmacies that we work through, specialty pharmacies. That channel has worked out really well. It also makes tracking the scripts a little imperfect. We're not, you know, broadly at retail pharmacies like a lot of medicines that these third parties track. So what we say is, look at it over time. Look at it on a monthly basis. Don't necessarily look at it on a weekly basis. And, you know, it might get better. It might actually get less accurate, you know, as we proceed. So, the third party that we see now, IQVIA, has done a pretty good job in recent weeks tracking it. And you see that steady growth really month-over-month.

We are impacted by, you know, some of the doctors being at conferences one week, but then they come back and they prescribe a lot more, once they have this top of mind. So we've seen that. We've seen winter storms. I mean, there's certainly an impact of week-to-week events. To your point, United's Optum had one of their pharmacies Change impacted. That was a minimal impact to us. We don't see that impacting us going forward. And again, one of the benefits of having, I think, four pharmacies versus some companies have had just one pharmacy out of the gates, and then you're really at risk for anything that happens to that one pharmacy.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

Good. That's really helpful. Thanks. So moving to the sort of gross- to- net and the payer dynamic, obviously, it was better than many expected, and you commented that was sort of non-contracted contracts, but you've also sort of spoken positively about some of the contracts that you have gotten on board. Can you talk about the two pieces of that, gross- to- net, and sort of what you think the trajectory of that will be, you know, throughout the next year or two?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Yeah. So this is a chronic disease. It's primarily driven by aging. My eight-month-old son probably already has mites because he got it from his mom and me, but it's really with aging that you get that overgrowth. So that means our population's half Medicare, half commercial. And what we anticipate is getting the majority of commercial patients contracted this year in 2024, and then next year having Medicare come on board. To your point, we've seen that great gross-to-net out of the gates without contracting. We have secured about a handful of contracts, including one from a very large payer, 19 million lives, on preferred status. Those contracts will help us, I think, both steadily improve that gross-to-net, but also, you know, really lock in the right prior authorization.

Ultimately, we want to assure that every patient gets this medicine for about $50 or less out of pocket. So, we do anticipate that steady increase in coverage over the course of this year and into next year, given the commercial Medicare dynamics. We expect to see, you know, steadily building on that gross-to-net that we've achieved today.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

Great. And you've quoted sort of towards a 50%, you know, gross-to-net. Is there any sort of possibility that you can improve on that even further with these discussions, just given how well they're going so far, it seems?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Yeah. No, they've been very strong. You know, we want to see how Q1 goes. There's, obviously, a deductible reset for patients in Q1. So we're not yet saying, you know, we're looking at something greater than 50%, but we do expect to build toward that 50% at steady state over the course of this year and into early next year.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

Great. Just in the last minute here, I want to just touch on the pipeline. You had positive data in MGD and Lyme disease and rosacea. Can you just quickly sort of talk about your plans for FDA meetings and sort of which of those programs you're most excited about taking forward?

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Yeah. No, they're all new categories. I mean, MGD, a disease maybe not everybody's heard about. That's Meibomian gland disease, the oily glands in the back of our eyelids. They're also impacted by mites. They can cause dry eye disease and other forms of irritation. We showed in a groundbreaking study that by delivering an antiparasitic, XDEMVY, you can actually improve Meibomian gland function. You can restore basically normal oil secretion and also, improve, back to normal, essentially, the function of those glands. So we don't want to be in dry eye, candidly. We're a Demodex blepharitis company. We see strong value with payers there. I think our next step is to talk to the agency. How do they see MGD, even with a phase IV data set, we think that's very powerful evidence to expand utilization of XDEMVY.

So we model that as about a 20%-40% increase in the market potential of XDEMVY. Rosacea, that's something a lot of people have heard about, hasn't been too exciting a space, candidly. Our medicine targets a specific subtype of rosacea, acne rosacea. That's caused by mites. It's the same biology as Demodex blepharitis. And we see an opportunity, as a beachhead, looking at the ophthalmic component of rosacea, essentially rosacea around the eye. And so that could be a very differentiating indication. We hear from our eye doctor customers that that's something they would like to treat their patients with. So we are looking at FDA conversations to really think about, is there a differentiated pathway in rosacea given the novelty of our medicine?

And that's a skin cream, TP-04, with the same API, lotilaner in the compound, in the product. And then finally, Lyme disease, a very intriguing opportunity, I think many of you in this room would say, if you could take something on demand as you go to a Lyme-affected area, whether you're golfing or hiking or vacationing, and you don't have to go get shots and it would work, over time, you'd take that. And so that's what we offer, an on-demand, durable prophylactic tablet. And so this has been proven in animals to work. We recently showed that we have over 90% tick-killing rate in healthy volunteers taking this medicine, TP-05, in tablet form. So we're very excited about that program. Candidly, it's something that's out of our wheelhouse commercially.

So we do want to talk to other, expert companies in vaccines and infectious disease. But that's an area where we need to define the path, right? When you're creating new categories, you have to actually have those regulatory conversations yourself and define what would a study look like, what would an indication look like, before I think you get real value for those programs. And frankly, that's what we've seen with XDEMVY. We've had to prove it, but we're seeing quarter-on-quarter that there's still a lot of people that aren't aware of the story and a lot of upside to come.

Eddie Hickman
Biotech Analyst, Guggenheim Partners

Great. I think that's our time. Appreciate you joining us, and congrats on all the progress.

Bobby Azamian
CEO, Tarsus Pharmaceuticals

Thank you, Ed.

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