Good morning. Welcome to the approval webcast of XDEMVY, formerly known as TP-03, for the treatment of Demodex blepharitis. Before we begin, I encourage everyone who has not launched the webcast to proceed to the Investors and News section of our website to find the link to this webcast and the related slides. As a reminder, this webcast is being recorded, and a replay will be available on the Investor and News section of the Tarsus website later today. We have one Q&A session at the end of today's program, and to ask a question, please submit your questions in the question and answers chat box, and then click Send. Today's slides may also be downloaded from the presentations section of our website or directly from the webcast. For technical assistance, click on the help icon.
I'd like to draw your attention to slide 3, which contains our forward-looking language statement. We will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional details. With me on today's webcast are Bobak Azamian, our Chief Executive Officer and Chairman, Aziz Mottiwala, our Chief Commercial Officer. With that, I'll turn the webcast over to Bobby, our CEO and Chairman. Bobby?
Thank you so much, Dave. What an exciting day for us here at Tarsus. You know, a week ago to the day, I welcomed my first child, August, held my son in my arms. That was the best day of my life, and I think today, with the approval, birth of XDEMVY, it's really the best day in our lives at Tarsus. That's because we now get to get this product to millions of patients. I'm so proud of XDEMVY. We'll hear more about the brand, the label, and talk about what we're doing next to get this to patients. Of course, this represents now the first and only approved treatment for Demodex blepharitis. I think many of you are familiar with the disease.
We've made incredible strides on building awareness of Demodex blepharitis, but let's talk about that to level set. Blepharitis has been known about for a long time. This is a disease that affects millions of patients in the US. Doctors, companies have known about blepharitis. Demodex blepharitis is really the main cause of blepharitis, and Demodex blepharitis affects 25 million Americans. We'll talk a little bit more today about how we're going to address those segments of patients in need progressively in our launch. This is a disease that creates a substantial burden for patients. On a daily basis, patients suffer inflammation, redness, irritation. This disease impacts daily life of patients suffering with it. The key to diagnosing this disease is a very simple test.
It's simply looking down a slit lamp, you can see this image on the left, collarettes forming in the base of the eyelashes. It's amazing. The more we know about this, we see our family members, our friends, people we know with this disease. It's so common and prevalent. Now, at last, we have an approval for Demodex blepharitis with XDEMVY. We're thrilled with the label. We're thrilled with the information we have in the label, so let me go over that. We have an indication that allows broad usage, that allows us simply to serve the millions of Americans with Demodex blepharitis.
We have efficacy data that includes really broadly all the data that we've had in our pivotal trials. That's an improvement in lids with a grade zero collarette reduction, eradication of mites down to zero mites per lash, and a cure of erythema down to grade zero. We know this is a safe and well-tolerated drug that's reflected in our label. From the start, we wanted a very convenient product profile, an eye drop twice daily for 6 weeks, a single course that delivered lasting value. You'll hear more about the product name, but I just want to comment for a second. XDEMVY. This is a product name that really gets to what this drug is doing, eradicating Demodex mites, the underlying cause, giving patients and doctors a sense of accomplishment, a sense of victory.
As we dig into the data, we see why that is. This is data from our label now, we see this collarette improvement, the portion of patients getting two or less collarettes. That is a change from cure, but that really reflects the complete resolution of collarettes, two or fewer, which is very consistent with all of the discussions we've had with the FDA and with all the data in our pivotal trials. We also see now in the label that many patients respond within two weeks, a very rapid onset of effect of XDEMVY. We get to talk about the broad effects of our drug, XDEMVY.
That includes mite eradication in over 50% of patients across 2 pivotal trials, a cure of redness, grade zero redness, which is very rarely seen with any drug, with any eye drop, and a very well-tolerated, well-demonstrated safety profile with AE rates of 10% or less. We now have all the information we need to get this drug on the market. We are ready to do that, and I will pass to Aziz Mottiwala, our Chief Commercial Officer, to talk about what's next, and finally, how we can realize our vision to serve millions of patients at Tarsus. Aziz?
Wonderful. Thank you, Bobby. Thanks for those on the call. Really delighted to share with you our plans to launch XDEMVY to the eye care community and be on our way to launch the next potential blockbuster in the eye care space. That, of course, starts today with the approval of the first therapeutic for the treatment of Demodex blepharitis. A product that uniquely gets to the underlying cause of disease and will enable us to unlock one of the most significant unmet needs in the eye care space.
There's one here for this one.
We'll do this with an effective and durable therapeutic, with no competitions.
Questions.
That will provide us a definitive standard of care. This has been established in two pivotal trials, where we've been able to show efficacy across multiple parameters. That compelling product profile creates a value position-
I will come.
For patients, doctors, and payers. We've already seen high receptivity from the eye care community. Ophthalmologists and optometrists are anxiously awaiting getting this product in their patients' hands. This product profile also will enable broad reimbursement potential. The feedback we've received from payers we've met with and surveyed indicate that all payers will cover this product. Knowing that, we've been ready. Our commercial platform is prepared for a rapid launch. We intend to have product available and our sales force deployed by the end of August, so that we can quickly and rapidly serve this market and get this product into the hands of the doctors and patients that are so anxiously awaiting this drug. We've seen this. We know that the doctors are ready. They see the disease, they believe that it's important to treat. They certainly intend to do so.
Through our market research, we've seen that over two-thirds of physicians recognize the importance of screening patients for collarettes, the pathognomonic sign of disease. It's also the primary endpoint in our clinical studies. When these physicians see collarettes, they know that it means the patient has Demodex blepharitis, and 93% indicate that they would prescribe an FDA-approved therapeutic for Demodex blepharitis. Now, I've been in the eye care space and working in therapeutics for a long time, and to see an intent to prescribe over 90% is truly remarkable, and I think, again, reflects the need in the market, as well as the compelling product profile that XDEMVY offer the eye care community. Knowing that need in the market, we've mobilized our commercial organization. We'll be ready within weeks with a best-in-class sales force to meet the needs of our eye care partners.
We've already established a strong leadership base, a team that has hundreds of years of experience across eye care, as well as launching new innovative products. We're in the process of building out the remainder of our sales force, 85 territory leaders, who will meet the needs of 15,000 eye doctors across the country, who account for over 80% of all the eye care prescriptions.
You see the question coming in?
We're actually in the process of interviewing those people today, and we've gotten over 4,000 resumes.
Let's see.
-from, for those 85 territories.
You can put it over here if you want to see them.
We'll be ready to deploy that sales force in the next couple of weeks and be ready to go. Previously, we've shared our plans around pricing. As I mentioned earlier, the feedback from the payer community has been quite positive. Payers understand that there's nothing available today. They like the profile that XDEMVY offers in terms of being able to address multiple aspects of disease with the definitive standard of care potential. To that end, we took that feedback into account as we priced XDEMVY. We looked across the eye care spectrum of drugs, thinking about the drugs that are highly commoditized, such as in glaucoma or dry eye, where prescriptions are about $300-$600 per script.
Also looking at the other end, where you have drugs to treat retinal disease, which often go for $2,000 per injection, where patients require multiple injections per year. With XDEMVY, we established a new category, pricing XDEMVY at $1,850 per prescription. Knowing the impact this drug has on patients, we expect to see one script per patient per year, which provides significant pharmacoeconomic value for payers, and our research and conversations thus far have reflected that sentiment. While we do expect one treatment per year, we do expect those retreatments to start coming in, but given the durability of effect, we don't expect those retreatments to come in until 2025. Again, a pricing that reflects the profile of the product and the strong value it provides the payer community.
To ensure that we're able to get this product in the patient's hands, we've also established a unique and innovative distribution model. A model that leverages a high-touch approach across digital and retail access points. This means patients can get the drug sent directly to them, or they can go to one of 18,000 retail pharmacy chains and get the product in their hands. The host of services we intend to offer these patients should lead to a higher fill rate, as well as a simplified patient experience, as well as a simplified experience for the doctors. We're going to be able to optimize the access we expect over time, and we're also implementing a robust set of assistance programs to help support these patients at launch.
Through these efforts, we intend to make the patient out-of-pocket cost for XDEMVY $100 or less per course of treatment. This is important because this is below the threshold we've seen in our research in which we see abandonment. Again, reflecting our commitment to make XDEMVY affordable and accessible for the patients that need it. At the top of the call, Bobby mentioned the 25 million Americans that suffer from Demodex blepharitis. We see that as a tremendous market potential. Near term, we've focused our efforts on the 7 million patients that are currently in eye care clinics looking for relief. These 7 million patients represent a multi-billion dollar market opportunity. That market segment is comprised of the 1.5 million patients who are already diagnosed with Demodex blepharitis, who are seeking treatment and have no good approved therapies until today.
It also includes dry eye patients who are on a prescription but have Demodex blepharitis and are not on the ideal treatment. Beyond that, we think about patients who want to enhance their vision, either through visiting their ophthalmologist to be consulted for cataract surgery or visiting their optometrist to optimize their contact lens use. All of these patients that have Demodex blepharitis could potentially benefit from XDEMVY. At a WAC price of $1,850 per script and a steady-state gross-to-net assumption of 50%, we can easily see the total market potential. Even treating a fraction of these patients, it's easy to do the math to see a billion-dollar peak sales potential in the next four to six years. The journey on that ramp begins today.
Between now and the end of the year, we will be focused on driving demand through early adoption and a positive experience. We want physicians and patients to see the full benefit of this treatment. We want them to have a great experience and build adoption through that experience. To that end, we'll be supporting that use through patient bridge programs and discounts to ensure patients can easily access the product as we build coverage. As we run into 2024, we expect to build our demand curve as well as our reimbursement curve. We'll establish commercial coverage throughout the year, with coverage coming on sequentially every quarter in 2024 on the commercial side. As that coverage builds, we expect our demand to build, as well as the prescribing depth and breadth.
As that coverage builds, we'll also begin to wind down our discounting programs, with 2025 representing the opportunity to access the Medicare coverage market. Once we establish Medicare coverage, we can continue to accelerate our revenue curve, optimize our gross to nets, and wind down our discounting programs. A very thoughtful, stepwise approach to a successful launch and building that potential to a billion-dollar peak sales. With that, I'll tell you that we are delighted to be here today. We're ready, and we're anxiously awaiting getting the product into patients' hands in the coming weeks. With that, I'll turn it back over to Bobby for closing comments. Thank you.
Thank you very much, Aziz. With today, we are poised to launch the next blockbuster drug in eye care. That's because, as Aziz has described, we have created a new category in the approval of XDEMVY, and we will show that category to be a blockbuster with all of the launch metrics that Aziz has described. As I reflect, it was less than 6 years ago that this was an idea, the process of category creation is pretty rare, pretty unique, going from a big unmet need to a very powerful drug, to proving that building a great team and now getting the product approved is a skill set that we need more of in eye care. I reflect on the team and really the village that has gotten this drug to this point.
I'm so grateful for the world-class Tarsus team, combining experts in eye care like Aziz, with true experts in biotech across our company. I'm also extremely grateful for the patients, the hundreds of patients who have helped us on our journey in our clinical trials. I'm grateful for those very first investigators and now literally thousands of doctors who are aware of XDEMVY, aware of Tarsus. I'm grateful for all the other stakeholders that helped us along the way, the FDA, whose clear and consistent collaboration has gotten us to this point. Many investors who have believed in our journey, I know will be rewarded as we look forward to the next couple of years. Finally, I want everybody to know that this is really the start. We are already looking beyond XDEMVY in terms of our company horizon.
We currently have three products in Phase 2, and they're all targeting a root cause of disease, creating new categories in different diseases, MGD, Lyme disease, rosacea. What you'd expect to see from Tarsus is us to do more of category creation in eye care, because there are so many patients in need, so many diseases that need better solutions. Thank you so much for your time today, and we will field your questions now.
Thanks, Bobby. Our first question comes from Dane, from Raymond James. Bobby, can you take us through the commercial process and expectations for access over the coming year?
Yeah. Aziz, could you please take that?
Sure thing. As we mentioned, between now and the end of the year, we'll get the product out there. There will be some significant discounting and bridging for those patients as we build coverage. The way to think about this is the market is about half commercial and half Part D. We intend to build that commercial coverage throughout 2024. We'd expect coverage to kick in early in the year and then build every quarter, and hitting sort of that major stride at the end of 2024. Part D, we're sort of waiting for the annual cycle there, right? That's an annual cycle that we need to go through, and we're going to put the bids in for that annual cycle to be on the formularies in early 2025....
The way to think about it is early experience and utilization in 2023, commercial coverage building in 2024, and Part D coming in in 2025, with commercial representing about half the market potential and Part D representing the other half in that market potential.
Thanks, Aziz. The next question comes from Tim Lugo. Can you discuss the eye irritation included in the label, and also remind us to the extent of irritation which is symptomatic of the disease?
Thank you, Tim. As mentioned, our label really gives us a broad representation of the product. Improvement in lids, mite eradication, erythema cure, and that provides breadth and completeness in terms of representation of the efficacy of our drug. You know, the irritation is something that patients experience. All our endpoints in our trials were very objective. We didn't include more subjective, symptomatic endpoints in our label. Our primary endpoints really focused on collarettes, which patients do notice. It's a form of debris that patients notice. It's a pathognomonic sign of disease, and that's how eye doctors are going to identify and diagnose this disease. Aziz, I'll ask for any additional comments that you can provide on really the irritation that patients see with this disease.
Yeah, I think, Bobby, you mentioned it, right? It's not uncommon to see that in patients that have Demodex blepharitis or other ocular diseases. I think when you look at the totality of this product profile, I think we're going to be in really great shape considering the tolerability and AEs. The tolerability is great, and the AEs are quite low. And, you know, you compare and contrast that to other eye drops where burning and stinging rates are significantly higher. I think we feel really good about the overall safety and AE profile of the product, and I think that the physician community will respond as well.
Our next question comes from Balaji Prasad of Barclays. What are the key points that excite you the most in the label? What do you think about the broad-based access with this label? Bobby?
Yeah, thank you. I mean, we are so happy with this label. Firstly, we have a broad indication, treatment of Demodex blepharitis, that will enable us to reach all the patients suffering from this disease. Secondly, really excited that all the data got included, and that includes the primary and two secondaries. It also includes the time course that I showed on the collarette primary. We can truly speak to the broad value and efficacy of this drug. That's what excites me the most. In terms of broad-based access, I'll again ask Aziz to comment. I think our patient distribution access is a really unique part of our strategy here.
Yep. Thanks, Bobby. I think when it comes to the label and access, the three things I would focus on are, 1, there's no restrictions or limitations on the patient population, so we'll be able to serve all the Demodex blepharitis patients that are out there. 2, to Bobby's point, we've got all the data in there, so we've got multiple efficacy endpoints, as well as the mechanism, which speaks to the direct and targeted nature of the drug. 3, we're going to be able to couple this with our robust distribution and patient savings programs to ensure access and affordability for these patients. I think when it comes to the payers, they're going to respond very favorably to the profile of the product and the label.
Again, the most important thing here is there's no restrictions on the label, no limitations on who can use this. It's a broad-based label that would allow us to treat these patients across the board. I think we're going to be in really good shape, given the nature of the label that we have.
Great. Our next question comes from Tim Lugo of William Blair. What is the status of the preservative-free formulation of XDEMVY, and will you also bring that formulation to the US after Europe?
Thank you, Tim. Preservative-free is something we're developing really exclusively for Europe, and that's because that's really the standard with any eye drop in Europe, is preservative-free. To be clear, there's nothing clinically adverse about a preservative, and we have a very commonly used and very soft preservative in sorbate, in XDEMVY. We do not intend to bring that formulation to the U.S. That's strictly for Europe.
Great. Next question comes from Hartaj, from Oppenheimer. Bobby, would you please compare and contrast dry eye disease to Demodex blepharitis in terms of launch?
Yeah, we have, Aziz, who's uniquely qualified to talk about that, having built, the dry eye market and now launching DB. So, Aziz.
Sure thing. Thanks for that question, Frank. You know, the way to think about this is there's a lot of similarities, but there's some key differences as well. Let's talk about the similarities. Large, underserved market that is likely to see diagnoses and treatments increase now that there's an approved product. Again, eye care focused. I think beyond that, we think about the differences here. When the dry market opened up, it was primarily driven by ophthalmology. Today, we have both ophthalmology and optometry driving prescriptions, which really creates a larger landing pad for these patients to get diagnosed and eventually treated. We have a much more rich prescribing audience, if you will. Secondly, I think the impact on patients is uniquely different.
With dry eye, it's a disease that the patients feel, and the doctors have to sort of explore to understand what's going on. With Demodex blepharitis, it's a disease that patients feel, but they can also see, and it's one that physicians can make a definitive diagnosis of by just doing a slit lamp exam, by looking for collarettes. You've got sort of a disease you can see and feel, which I think, again, will facilitate easier and more definitive diagnoses for these patients... lastly, I think that we're launching into a market where there's nothing available today. There's no standardized over-the-counter, there's no competition, so it's really incumbent upon us to build this market without any competition.
I think that's very different where we see dry eye, where even with the first prescription product, there was a tremendous amount of over-the-counter options for these patients that worked quite well. In fact, in my prior life, we marketed both those products, which gave patients significant alternatives. Here, there's really no alternatives, and I think that sets us up for a compelling value proposition with a product that has a standard of care potential. Again, just to summarize, a much more rich prescribing audience, a disease that allows for more intuitive diagnoses, and one with truly no other alternatives for these patients, I think will facilitate strong uptake in the market.
Thanks, Aziz. A follow-up from Frank: Do you intend to have the entire sales force ready and hired by the end of August?
Aziz?
Sure thing. The plan is, as we've talked about, is we expect to have product available by the end of August. Our sales force deployment will coincide with that product availability by the end of August. We expect to deploy the entire sales force at that time.
Great. Our next question comes from Jason of B of A. Can you talk about the SG&A step-up in the second half post-approval? Should we factor in additional costs beyond the 100-person sales group?
Yeah. We're not giving that formal guidance today. I think, what you can expect to see is about 20%-30% quarter-over-quarter increase in our total OpEx as we launch the product. I will ask Aziz to comment on additional costs beyond the 100-person sales group.
Yeah, without getting into the gory details here, you know, there are gonna be marketing costs, obviously, on getting the product out there, et cetera. I think, Bobby, the guidance you're giving here is probably appropriate, but, yeah, the other costs you're thinking about just the marketing costs that go into launching a product beyond just the sales force as well.
Great. A follow-up, from Jason: How do you expect XDEMVY to be used prior to full year 2024 broader payer coverage? Can you talk about the phasing of select plan coverage and/or ability to secure reimbursement via medical exemptions?
Aziz?
I think the question there kind of intimates what we expect to happen, right? Early days, between now and the end of the year, we'll be encouraging physicians to prescribe this. If coverage is absent, we'll obviously provide discounting and bridging to help meet the needs of the patients to get the product in hand. There are mechanisms through exceptions or letters of medical necessity, where we can tap into coverage, and we'll certainly look at those options to meet the needs of those patients. Beyond that, 2024 is really the year to build that commercial coverage. Each of these payers that we talk to in the commercial side all have different timelines, where P&T committees meet, you know, when they allow products to get on formulary.
I think the way to think about this is that we should expect coverage to start to build as early as the first quarter of 2024, and then build consecutively each quarter thereafter, reaching critical mass, the vast majority of commercial lives before the end of the year in 2024.
Thanks, Aziz. Our next question comes from Patrick Dolezal of LifeSci. Digging into the payer survey indicating 100% coverage of XDEMVY, does this include all the major payers, and how does Medicare fit into this picture?
Aziz, please.
Yeah, so that reflects research we've done across a wide swath of payers, as well as through our direct engagements, where we've engaged the vast majority of major payers, both on the commercial and Part D side. As it applies to Part D, the way I think about it is it's not a if, it's a when. The payers have indicated that they would cover this, particularly because there's nothing else available today. Obviously, we've talked about the robust product profile. With Part D, it's really a matter of going through the annual bid cycle, which is going to be active now for 2025. The 2024 bids are essentially set. Those formularies are locked in, so we'd anticipate putting in bids for the 2025 formulary. Again, it's just a matter of time that we have to wait through that process to get there.
Great. The next question comes from Tim Lugo: What's your intent on building out the data around retreatment with XDEMVY?
Yeah. We have a very active medical affairs effort, that will include phase IV studies. We're not commenting specifically on those at this time. I'll say that, Saturn-1 had great extension data, that we published, and, that shows that the drug, XDEMVY lasts for at least 6 months, and by a year, about 40% of patients recur. That's really the foundation of the data that we'll continue to build out around retreatment.
Great. Thanks, Bobby. Our next question comes from Jason, from B of A. What do you view as a good comp for XDEMVY? Does the topical Opzelura serve as a good comp, and why?
Aziz, you want to take that?
I think, you know, when we think about XDEMVY, comps are really interesting, right? I think this is first in class, no competition, and obviously the unique part of this drug is the fact that it's a treatment that is used probably once a year, and you don't have those refills. I think that's one thing to keep in mind when we think about comps. I think the Opzelura one's an interesting one.
I think where that really applies is, I think that team had done a really nice job of demonstrating the ability to discount early on and then phase that down as coverage builds. I think that's a great proxy for how we're thinking about our coverage and discounting scheme in terms of as coverage increases, discounting should come down. I think that's a good proxy for that being executed well, right? Where each quarter you saw them build coverage, then each quarter the discounting came down. I think that's a good way to think about gross-to-net appreciation over time, coinciding with that script curve building up over time.
Thanks, Aziz. Our next question comes from Eddie Hickman of Guggenheim. Given your coverage plans and expected uptake, how should we think about the gross-to-net improvement? If the goal is at 50%, where do you expect to start, and what is the cadence over the first few quarters? Will uptake in the Medicare population only pick up when you have coverage in 2025?
Aziz, keep rolling.
Sure thing. I think, from a gross perspective, we're not giving specific guidance on that. What I would say is that gross-to-net should be improving every quarter. I think we expect to be comparable to other recent launches in the first couple of quarters, and then rapidly build as commercial coverage kicks in through 2024, and obviously hitting steady state in 2025 when Part D coverage kicks in. To the question around Part D coverage, yeah, we expect that coverage to hit in 2025. Between now and then, there should be avenues in which patients can access this, either through discount programs or, through letters of medical necessity or formulary exceptions, all of which, we'll be providing assistance for and guidance to for those patients to help facilitate, an easy process to getting on product.
It isn't that these patients won't be able to access the drug at all, it's that it'll be easier and obviously, from a gross-to-net perspective, more beneficial for Tarsus, once that coverage kicks in in 2025.
Great. Thanks, Aziz. We have time for one more question. The last question comes from Oren, from H.C. Wainwright. Is there anything in the label regarding retreatments? Since you've highlighted the WAC price, and it assumes one treatment per year, what do you expect regarding insurance coverage for retreatments?
Yeah. Nothing in the label limiting retreatments. I'll ask Aziz to comment on the insurance coverage question.
Yeah, I think the way to think about this, to Bobby's point, is the label really enables us to promote this product for anybody that has active disease, right? If you have, essentially, if you have collarettes. I think that's gonna be the requirement that payers will look at. If the patient has active disease, they'd be eligible for treatment. Based on the studies we've seen so far, that durability lasts anywhere from 6 to 12 months. I think the trigger for patients getting coverage here is, do they have collarettes? Do they have active disease? As long as that's identified by a clinician, they should be eligible to receive reimbursement for that treatment.
Thanks, Aziz. Thanks, Bobby, again. This concludes our webcast. Thank you again, and have a great week.