Tarsus Pharmaceuticals Inc

NASDAQ:TARS

Earnings Call Transcript 2024-Q3

[Operator]

Good afternoon, and welcome to Tarsus' Third Quarter 2024 Financial Results Conference Call. As a reminder, this call is being recorded.

At this time, I would like to turn the call over to David Nakasone, Head of Investor Relations, to lead off the call. David, you may begin.

[David Nakasone, executive]

Thank you. Before we begin, I encourage everyone to go to the Investors section of the Tarsus website to view the earnings release and related materials we will be discussing today.

Joining me on the call this afternoon are Bobby Azamian, our Chief Executive Officer and Chairman; Aziz Mottiwala, our Chief Commercial Officer; Sesha Neervannan, our Chief Operating Officer; Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer; and joining us for the first time, Dr. Elizabeth Yeu, our newly appointed Chief Medical Officer, for the Q&A portion.

I'd like to draw your attention to Slide 3, which contains our forward-looking statements. During this call, we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional detail.

With that, I will turn the call over to Bobby.

[Bobak Azamian, executive]

Good afternoon, everyone, and thank you for joining us. 2024 continues to be a year of tremendous growth for Tarsus as we execute on our vision to revolutionize treatments for patients in need. And I'm pleased to share the results of our most successful quarter to date.

In the fourth full quarter of our launch, we generated more than $48 million in XDEMVY net product sales, driven by more than 41,000 bottles delivered to patients impacted by Demodex blepharitis, or DB. As the launch continues to accelerate, we are even more confident in the potential of XDEMVY. This confidence stems from continuing to deliver on our strategy and adhering to our category-creating fundamentals. We are executing on all fronts with a sharp focus on education, ease of access and even more evidence generation to come.

We expanded our sales force from approximately 100 to 150 at the end of the third quarter and we are starting to see a meaningful increase in the number of eye care professionals or ECPs prescribing XDEMVY as well as the number of ECPs who write multiple times a week, a leading indicator that depth of prescribing is trending in the right direction. One of my passions as CEO is remaining connected to the field and engaging with ECPs in their clinics.

In my most recent field visit, I met with one of our top prescribers and saw firsthand the power of repeat interactions in further deepening the use of XDEMVY in DB patients. These repeat visits, combined with ease of access and shared evidence, are accelerating that prescriber's desire to look for and treat DB in all of their patients. This also illustrates that even our top prescribers haven't come close to reaching their limit.

While our sales force is doing great work to further build upon the solid foundation we have established, we are also generating additional evidence to further educate physicians and patients on the impact of DB and potential benefits of XDEMVY. Just last week, groundbreaking positive data in DB patients with meibomian gland disease, or MGD, was presented at the American Academy of Optometry. These data represent the first time a DB therapeutic has demonstrated statistically significant and clinically meaningful improvements in objective measures of MGD and in specific disease symptoms that impact how patients look, feel and ultimately see. Based on conversations with KOLs in the field and at the academy, this data set provides the evidence they have been waiting for as they look to expand their use of XDEMVY.

In addition to expanding our sales force and generating additional data, we also activated our first direct-to-consumer campaign on streaming television that leverages creative and memorable visuals to illustrate the damaging impact of the disease. The goal of the campaign, which you can view on xdemvy.com, is to support patients in their journey and understanding of DB and to encourage them to consult with an ECP to see if XDEMVY is right for them. If you haven't seen it, I encourage you to do so as it is truly a unique and motivating approach to patient education.

Finally, we made tremendous progress with payers again this quarter. We secured both additional commercial coverage and the 2 remaining large Medicare contracts, bringing total covered lives to more than 80%, a remarkable statistic this early in the launch.

Turning to our world-class leadership team. You may have noted that we added 2 very well-established, well-regarded clinical leaders who will further strengthen our position in eye care. It gives me great pleasure to welcome Dr. Elizabeth Yeu as our new Chief Medical Officer. Liz has supported us for many years as both our Chief Medical Adviser and a member of our Board of Directors, and we are pleased to apply her strategic expertise and leadership so directly to our efforts to improve patients' lives. Liz is a distinguished ophthalmologist with more than 2 decades of real-world experience and she will no doubt have a significant impact on our newly created medical organization, leading evidence generation, medical education and providing oversight of patient safety.

We are also delighted to welcome Dr. Kate Goodrich to our Board of Directors. As the Chief Medical Officer of Humana and former Chief Medical Officer of the Centers for Medicare and Medicaid Services, Kate brings a unique skill set and perspective to the Board that will help us think more creatively and broadly about ease of access, health equity and other value-based initiatives to ensure better patient outcomes.

Finally, you'll hear from Sesha about our robust pipeline of other category-creating assets that continues to advance.

Our accomplishments so far this year, our strength in leadership and the strategic investments we are making continue to move us closer to achieving our vision of becoming an eye care leader.

With that, I will turn the call over to our Chief Commercial Officer, Aziz Mottiwala, for more details on our commercial progress. Aziz, over to you.

[Aziz Mottiwala, executive]

Thanks, Bobby. Let me be one of the first to welcome Liz and Kate to Tarsus. Kate, your rich experience in both the government and private sector exploring innovative solutions to ensure health care access, equity and affordability will be a tremendous asset to the team. And Liz, I've known you for almost 20 years and it's been wonderful to witness all your contributions and accomplishments. I look forward to working with both of you as we continue delivering on the blockbuster potential of XDEMVY.

As Bobby noted, we are proud of the impact we're making on patients and the ongoing strong performance of XDEMVY. We've delivered on the promises we made and our differentiated and unique launch strategy is continuing to set the standard for product launches. Stepping into the next phase of growth, we are pouring even more fuel on the fire by deepening interactions with our expanded sales force, proactively communicating new DB data, which you'll hear more about later in the call, and launching an impactful and memorable DTC campaign that empowers patients.

This summer, we expanded our sales force by approximately 50%. While we're still in the early days of this expansion, I am pleased to report that we are already seeing the positive impact of more engagements with our ECP targets. As we've said, it can take about 5 to 10 visits from a sales rep to convert an ECP from XDEMVY trialist to prolific writer. More reps in the field means more quality time with ECPs, reinforcing the positive impact XDEMVY is having in their practice and encouraging them to think more broadly about the other patient segments we've talked about that might benefit from XDEMVY. As you can see from the growth in prescription volumes week-over-week, this increased engagement is having a meaningful impact. To date, more than 13,000 ECPs have started patients on XDEMVY and over 70% of those are prescribing XDEMVY to multiple patients. We've also seen a meaningful increase in the number of ECPs who write XDEMVY 5 or more times per week, which speaks to the depth of prescribing we're driving.

Furthermore, we are seeing increasing adoption and utilization in the additional DB patient segments of dry eye, cataracts and contact lens users. This is further validated by our latest market research, which shows that even at this early stage, approximately 40% of ECPs surveyed are already prescribing XDEMVY across each of these additional patient segments. And over 90% of these ECPs indicate they plan to increase utilization across these segments in the near term. In parallel with the increasing sales and prescriptions, we also made significant progress on the reimbursement front by securing additional commercial coverage and the 2 remaining large Medicare contracts, of which we should start to see the benefits in 2025.

With these wins, we are now covering more than 80% of patient lives. That's an exceptional achievement on its own, but I also want to note that we did it faster than we said we would, and faster than I've seen it ever happen in eye care.

Another significant growth driver we initiated this quarter was the activation of our first direct-to-consumer campaign on streaming television. And I'm pleased to report that the response has been incredibly positive. Like all of our educational initiatives, we listen and learn from our stakeholders, and this impactful and action-oriented campaign is the result of hundreds of conversations with patients. The campaign describes the root cause of DB in a way that is humorous and memorable without undermining the serious impact it can have on patients. It is also relatable and reassuring. For patients who may have struggled for years with red, crusty, itchy eyes, this ad provides both the why and a solution. And it's clear the message is resonating by the number of people watching the ad, as well as the volume of people visiting the XDEMVY website and the time they spend on the site engaging with the content materials. Although we are still in early days, we expect to see a measurable impact on sales in early 2025, at which time we would consider expanding into network TV.

Further driving the potential impact of XDEMVY is the exciting new MGD data in DB patients presented last week. You'll hear specific details from Sesha in a moment, but I have to say the initial response from KOLs has been tremendous. Several high-prescribing doctors sought me out during the recent academy conferences to say how excited they were to see such tangible patient outcomes. Everything we heard during these conferences suggests ECPs are highly motivated by the data and plan to increase the use of XDEMVY across a broader spectrum of patients. Based on the strength of these data and the reaction from the ECP community, we have made the strategic decision to pursue a data dissemination approach so that patients can benefit immediately.

We believe that an additional 1.5 million patients with MGD are presenting with DB and many are already in the office of our target physicians, which expands our potential patient population by at least 20% over time.

In closing, the strong progress we've made this quarter really speaks to the power of our category-creating fundamentals, our innovative approach, the right leadership team, and as Bobby mentioned, a clear focus on execution, education, ease of access and continued evidence generation. And with our new initiatives in place, we expect to see a strong close to the year and even more growth in 2025.

Thank you all for your time. I will now turn the call over to our Chief Operating Officer Sesha Neervannan, to share the key updates from our pipeline. Sesha?

[Seshadri Neervannan, executive]

Thank you, Aziz. It gives me great pride to see the impact of XDEMVY on patients and the potential of our pipeline to serve even more. As you've heard from Bobby and Aziz, we are very excited about the positive data from the Ersa and Rhea trials that were presented last week at the American Academy of Optometry or AAOpt, and it's my pleasure to tell you why.

First, a reminder about MGD. MGD is a chronic eyelid condition that occurs when the meibomian glands do not secrete enough high-quality oil. It is associated with Demodex infestation, which can lead to progressive gland loss and potentially affect vision.

The combined data from Ersa and Rhea shows that XDEMVY is the first pharmacologic treatment to demonstrate statistically significant and clinically meaningful improvements from baseline as well as when compared to vehicle across multiple objective measures of MGD and patient-reported symptoms.

I'll start with the objective measures of the disease. In addition to significant improvements in the meibomian gland secretion score and the number of glands secreting normal or clear liquid that we reported previously, this new XDEMVY data show unprecedented improvement in the number of meibomian glands yielding any liquid secretion.

As this graph illustrates, you can clearly see 51% improvement from baseline at day 43 with XDEMVY-treated patients, while the vehicles did not have any effect. In addition to the objective measures of the disease, we saw profound improvements in some of the most common and impactful patient symptoms, specifically fluctuating vision, itching, redness and burning. As these graphs highlight, XDEMVY demonstrated a 52% improvement in fluctuating vision and a 64% improvement in itching, both at day 43. In summary, this data really gets to how patients look, feel and what every patient cares about the most, how they see.

Given the clear and compelling results of these studies, plus FDA feedback that these patients are already covered under XDEMVY's comprehensive label, our medical affairs team is moving forward with broadly sharing these data with ECPs in an effort to help as many patients as quickly as possible. This is a very exciting new development for ECPs, patients and for Tarsus, and I look forward to partnering with Liz as we continue to generate even more evidence about the immense potential of XDEMVY across a range of patient types.

Beyond our efforts to expand the DB market and provide ECPs more reasons to treat, we are also pursuing opportunities outside of the U.S. We recently met with European Medicines Agency, or EMA, who informed us that an additional Phase III study will not be required for approval of XDEMVY in Europe. We remain on track for advancing XDEMVY with the potential for approval in the second half of 2027.

Similarly, in the U.S., we remain on track to bring both TP-04 for rosacea and TP-05 for prevention of Lyme disease to the FDA by the end of the year. We look forward to providing an update on these programs by our full year 2024 earnings call.

I'll now turn it over to Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer, to discuss our strong third quarter 2024 financial results. Jeff?

[Jeffrey S. Farrow, executive]

Thanks, Sesha. Q3 marked our strongest quarter to date, highlighted by $48.1 million in XDEMVY net product sales, more than 41,400 bottles dispensed to patients, a gross to net discount of approximately 40% and securing additional commercial and the 2 large remaining Medicare payer contracts. As Aziz mentioned in his remarks, these robust numbers are thanks in part to the deployment of the expanded sales force in the third quarter, beginning in the month of September.

With the sales force hard at work to increase the depth of prescribing among our more than 13,000 prescribing ECPs, we saw steady growth in prescriptions despite the headwinds we mentioned previously, the traditional summer slowdown in ECP offices, vacations and holidays, and time-out of the field onboarding the expanded sales force. The improved gross to net discount reflects the continued coverage we secured earlier in the year, as well as an adjustment to our estimate for the Medicare accrual for the first half of 2024, resulting in a reduction of our gross to net discount of approximately 3% or approximately $2 million. Absent this adjustment, our gross to net discount for the third quarter would have been about 43%, which is in line with what we guided to on our previous earnings call. As a reminder, our gross to net accruals in any given quarter are based upon estimates that are trued up upon subsequent invoices and data received.

Turning to our P&L. Total operating expenses were approximately $73.3 million for the third quarter of 2024 and remained relatively flat, inclusive of the expanded sales force, offset by other sales and marketing costs. Gross margins for the third quarter remained relatively flat at approximately 93%, which includes the royalty and the amortization of any milestones we paid to Elanco. Finally, we ended the third quarter with $317 million in cash and marketable securities.

Looking ahead to the fourth quarter, we expect continued growth in XDEMVY prescriptions with more frequent visits to our ECPs and patients working to maximize their insurance plan benefits before they reset in 2025. Specifically, we expect the number of bottles dispensed to patients to grow at a substantial rate and we are providing a range of approximately 50,000 to 55,000 bottles of XDEMVY to be delivered to patients in the fourth quarter. This guidance includes the traditional fourth quarter headwinds such as multiple eye care conferences and holidays, including Thanksgiving, Christmas and Hanukkah. In line with previous quarters, the vast majority of these bottles will be delivered to new patients as we are not yet seeing meaningful retreatment volumes.

Moving to the expected gross to net discount. Now that we have secured broad commercial and Medicare payer coverage, we reiterate a gross to net discount in the range of approximately 42% to 46%, exiting 2025 at the lower end of this range. Looking specifically at the fourth quarter of 2024, we expect to see the potential for a 1 to 2-point increase in the gross to net discount due to the anticipated impact from the donut hole for which we did see an increased trend in our third quarter. In other words, at the high end of the 42% to 46% range we are providing.

Moving through the P&L, we expect an increase in total OpEx due to the full quarter impact of the expanded sales force, our new DTC campaign and other XDEMVY-related marketing costs.

In summary, we expect to deliver increased sales growth as we close out 2024 and enter 2025 from a position of strength. We look forward to sharing more updates with you next year.

And I will now turn the call back to Bobby for final remarks.

[Bobak Azamian, executive]

Thanks, Jeff. As you heard today, we are incredibly proud of the impact we are having on patients, and it is an exciting time for the company as we initiate the next set of growth drivers for XDEMVY and our pipeline on our way to becoming a leading eye care company. We appreciate your time and engagement today.

Operator, please open the line for questions.

[Operator]

[Operator Instructions]

[Bobak Azamian, executive]

Before we take the first question, I just want to make a few points highlighting the great quarter and progress to come. First, we're already seeing great growth from our strategic levers of education and ease of access.

Secondly, I'm hearing continued broad enthusiasm from ECPs in a range of settings, conferences and their clinics. And to me, that illustrates the further gains to be had from depth of prescribing.

Third, we have not yet seen the potential of our sales force expansion and our access wins. And there's even more to come through our new DTC campaign and MGD and DB data shared today.

And finally, although not highlighted today, I'm confident that our pipeline contains additional category-creating opportunities.

Looking forward to your questions.

[Operator]

Our first question comes from Eddie Hickman with Guggenheim.

[Eddie Hickman, analyst]

Congrats on a really great quarter. Just a few questions from me. Will the MGD expansion that you're planning require another sales force expansion or another targeted DTC?

And then you noted you're not seeing too many impacts of retreatments. Can you talk about when you might expect to see that impact and sort of how payers are thinking about reimbursing those?

[Aziz Mottiwala, executive]

Eddie, it's Aziz. Thanks for the question. Yes, I think the thing to keep in mind with the MGD data in patients that have DB and I think the key opportunity here is going to be for clinicians to start screening their MGD patients more purposefully for Demodex blepharitis. So that falls in the current indication of the product. It also falls in the current call panel that we have with our sales force. So we're able to reach all these doctors. You could see that it would be a really clear message that we would have to expand how doctors think about DB permeating in their office, essentially another meaningful patient segment to look for this disease.

So we don't anticipate any changes to the sales force, nor do we anticipate any changes or requirements for additional DTC. I think the DTC overall will be driving patients in. And again, this will be another trigger for doctors to look for the disease more purposefully. So we think that those are both aligned and ready to capitalize on the opportunities that are in front of us.

And then in terms of your question on retreatment, I think what we're seeing right now is it's still pretty early. We see about a single-digit retreatment rate in this syndicated data. And I think that over time, we would expect that to get to about a 20% rate, as we stated before.

But I think it's still a little early to be able to lock down an exact number there. But I think that over time, we'll see that trend increase and probably settle in that 20% range.

[Eddie Hickman, analyst]

Just 1 quick follow-up. I noticed that the sort of IQVIA capture rate evolved a little bit this quarter. I'm wondering if you have any comments about that and if you think it'll sort of maintain in that range.

[Jeffrey S. Farrow, executive]

Eddie, it's Jeff. And as we've always cautioned, IQVIA is imperfect data at best, and it fluctuates up or down, sometimes as much as 10%. I would say, lately, we've seen a little bit more of a modest increase over what our actuals are. So I think we just don't know what that will translate into in subsequent months. But that's what we've seen over the last couple of weeks here.

[Operator]

Our next question comes from Lachlan Hanbury-Brown with William Blair.

[Lachlan Hanbury-Brown, analyst]

I'll add my congratulations. I guess I'd just be interested to know a bit more on how you're sort of measuring the effectiveness of the new sales reps. Like are there hard KPIs or metrics that you can talk about or share to kind of help us understand how you're evaluating the impact they're having?

[Bobak Azamian, executive]

Sure thing, Lachlan. Thanks for the question. Obviously, with the sales reps, we look at a myriad of different metrics. Internally, we look at things like call productivity, how often we're reaching the customers, how many calls we're making a day. Ultimately, the key measure here is the scripts that we're really focused on, right? What's the impact on this? I think you've seen already, as we talked about, the prescriber base continues to grow. We made comments on the doctors that are writing more often on a weekly basis.

So we're seeing those great indicators. But ultimately, we want to see continued patients getting on treatment. And I'm pleased to say that over the last few weeks, we've seen a real positive trend there, right? So sales force was out there towards the very end of Q3, and I think we started off Q4 with really great momentum with that expanded sales force being out there.

So more to come there. It's still very early. You can imagine those reps are just getting out there talking to the customers. But we're really pleased that we're already seeing a pretty immediate impact of having that expanded group of salespeople out there.

[Lachlan Hanbury-Brown, analyst]

Got it. And Jeff, if I could add one on just the Medicare donut hole is impacting the end of this year. But obviously, next year we've got changing dynamics there with the out-of-pocket caps. Is there any -- I know you're not providing '25 guidance, but is there any commentary you have on maybe just like the cadence of the donut hole over 2025 with those changes?

[Jeffrey S. Farrow, executive]

Sure. Yes. It remains to be seen in actual impact, but our expectation is it's going to smooth it out over the year as opposed to being sort of cyclical. Most companies typically run through it in the first half of the year, as we've highlighted. For some reason, our patient population seems to be hitting it more in the back half of the year. Our current expectations is we'll probably see it more evenly spread throughout the year instead of the sort of peaks and valleys.

[Operator]

Our next question comes from [ Andrea Newkirk ] with Goldman Sachs.

[Unknown Analyst]

Aziz, maybe a follow-up here regarding the strategy for these patients who have MGD and overlapping DB. Just curious if this suggests that you wouldn't look to expand to the broader MGD population for those who don't have the overlapping DB that would be already covered by your label? And then can you just remind us what would be needed to pursue such an expanded label if the latter is still the case?

[Seshadri Neervannan, executive]

Thanks, [ Andrea ]. This is Sesha. I'll take that question. Thank you for that. So the study that we did was focused on MGD who have DB patients. And so the data strongly supports that while you treat for a DB, you're improving MGD functions and patient-reported symptoms. So our plan -- and FDA also confirmed that this falls within the broad indication that we already have on XDEMVY. So our plan is to continue to educate the physicians on the use of XDEMVY to treat DB and -- in MGD patients. At this point, we -- because the data is so compelling, and we have, as Aziz mentioned earlier, a significant segment of the patients that are remaining to be treated. at this time, we don't have any plans to expand the label. And we are going to continue to educate ECPs on the new data to get to as many patients as possible.

[Aziz Mottiwala, executive]

And I just want to add on that. Having been at the academies recently and talked to a number of physicians, there is just really strong key opinion leader and ECP enthusiasm for this data. I really think it's going to cause more doctors to look for DB more broadly in their MGD patients. So we're really excited about the impact to come.

[Unknown Analyst]

Great. And then, Jeff, maybe 1 question just here on the gross to net adjustments. Can you just remind us what analogs you're using or maybe what assumptions you're making to get to that long-term estimate of 42% exiting 2025?

[Jeffrey S. Farrow, executive]

Sure. No, what -- we looked at some traditional analogs in the eye care space. And that's why we initially estimated probably most of the patients coming through in the first half of the year. But that wasn't the case. We saw that a lot of these patients are much healthier than a lot of the typical eye care patients.

And so what we're seeing is the impact in the back half of this year. We saw a trend in increase in Q3 despite the fact that we did reverse the accrual on the first half of the Medicare donut hole. But we did see a trend and we're expecting that trend to increase into the fourth quarter. So that's why we've guided to sort of the higher end, the mid- to higher end of that gross to net discount.

On the long-term impact, again, just based on what we see on the contracts coming through, we have now broad coverage in both Medicare and commercial. And so based on that and what we knew is what the contracting values are, we do expect to be at that low end of the range, somewhere around the 42% to 43% at steady state sometime starting in the middle of, say, 2025.

[Operator]

Our next question comes from Oren Livnat with H.C. Wainwright.

[Oren Livnat, analyst]

On SG&A, it's interesting to see that down quarter-over-quarter despite some onboarding of those reps and other investments. I'm just curious, is the -- if you can talk about the moving parts there, but specifically, the benefits you're seeing with the new contracts in Medicare and other commercial coverage, is the reduction in perhaps bridging supply or free drug that's maybe going to previously uncovered patients, is that coming out of SG&A now? Maybe it was previously almost like treated like sampling. So we're seeing that benefit in Q3 already? And I have a follow-up.

[Bobak Azamian, executive]

No. The primary impact, as you highlighted, was the onboarding of the commercial team, the incremental 50, and they started in September. Some of the down -- I would say, the offset to that is other sort of general sales and marketing. I wouldn't say there's one that we would specifically highlight, but a variety of that that did lead to the overall sort of flatness on that SG&A front.

I do anticipate in the fourth quarter, that's going to pick up with the DTC campaign ramping up. And then, of course, we'll have the full quarter impact of the sales force at that point.

[Oren Livnat, analyst]

Okay. And on Europe, can you give us your thinking? I know it's quite early. But what's your understanding of relative pricing for a category-creating product in eye care in Europe? Should we assume that that's going to be more favorable than the pretty extreme compression on pricing we've seen in other eye care products that are in competitive markets relative to U.S. pricing?

[Aziz Mottiwala, executive]

Yes, Oren, it's Aziz. So I think when we look at Europe, we see a couple of things. One is there's a market there that's very significant. The prevalence is very similar to that of the U.S. on a per population basis. So there's certainly a need. We've heard from thought leaders in Europe that there is a desire now that they're seeing the success XDEMVY is having for patients in the U.S. to see this product available more broadly.

To that end, we're starting to do some work on the educational front, investing in education, engagement with the thought leaders in Europe to really understand how we can get this product into more patients' hands. And part of that work is obviously understanding the reimbursement landscape a little bit better. So that's ongoing work.

I will say that given the effective product profile that XDEMVY brings to the table, the value it provides to patients, we definitely see that this is a unique and differentiated product. But obviously, a little bit more work to do in terms of really understanding the reimbursement dynamics as it varies by country, as you can much appreciate.

[Oren Livnat, analyst]

All right. So TBD.

[Operator]

Our next question comes from Balaji Prasad with Barclays.

[Balaji Prasad, analyst]

Couple from me. Firstly, could you, with around 1 year of launch now, provide some color on seasonality and trends one should expect to see? Asking as we had Q2 where you had commentaries around Memorial Day holidays and medical conferences and Q3 had summer holidays being called out. So how should we think about broad seasonality during the year? That is one.

Two, on the R&D side, can you comment on the nature of more evidence generation that you plan to provide? And how would you plan to leverage this for any incremental impact with the sales force?

[Bobak Azamian, executive]

Great. I'll start on the question around seasonality. I think -- Balaji, I think while it's still -- you're in relatively early as we're continuing to build this market. I think there's a couple of things that we do know, right? We do know that what we saw over the summer was a little bit of slowing. We saw during the summertime, both patients and doctors are not going into the office as often as they would other quarters. So that's something that we would definitely keep in mind as we look to 2025.

And I think the other key thing that we do know is that the first quarter across all markets is always a little challenging, right as you get deductible resets, plan resets and patients coming in. So I think those are the 2 areas to look for where we might have a little bit more than normal headwinds.

But other than that, I think that we'll learn more as we get into another full full year of launch here. But I think those are the 2 big things that I think about, first quarter resets and then the summertime sort of holidays and vacations that sort of impact people going into the office.

And then I'll let Sesha speak to the R&D piece.

[Seshadri Neervannan, executive]

Yes. Thanks, Balaji. So as Bobby mentioned, we got really positive feedback from all the conferences. And as we continue to hear more from physicians, real-world experience on XDEMVY, we are listening and learning about what additional evidence that they would like to see. And as you saw with the MGD data that we just shared, one of the key pieces of evidence we shared is the impact on symptoms, which is something that the physicians have been asking and that's an additional evidence that we generated.

As you may know, we also have a study ongoing in another patient segment with contact lens intolerance that would add additional evidence to XDEMVY use. And we'll continue to listen and learn and think of more areas to generate and we'll come back to you with [ data upfront ].

[Operator]

Our next question comes from Jason Gerberry with Bank of America.

[Jason Gerberry, analyst]

A couple for me. Just on the Part D tailwinds, trying to think about that going into next year. I guess the previous assumption was that there might be some slow play of the increased access over the course of '25. So should we think about half the market that wasn't in play in '24 kind of switching on the spigot in the beginning of 2025? If you could just kind of dimensionalize that, that would be helpful.

And then on the retreatment question, I'm wondering, are plans limiting these patients at all in any way through policy to single script per year and thus patients may get retreated, it just may not be in the same calendar year when they do get retreatment?

[Bobak Azamian, executive]

Great. Thanks for the questions, Jason. And in terms of Part D, I think I'd just highlight how pleased we are with the progress we made over the last quarter here, right? Being at over 80% of lives covered a full year out from launch is remarkable. And that means we've got great coverage on commercial as well as Part D now. I think the way to think about this is, as we mentioned before, a lot of these changes kick in in 2025. We do see that those things take a little bit of time as the plans push this through sort of their downstream clients. And I think that the other effect that you have, again, as I mentioned earlier, is the Q1 reset.

So I think that this would be definitely an opening of that second half of the market. We were seeing Part D scripts come through prior, right, through letters of medical necessity, prior auths, et cetera. This will ease that process and I think over time, we'll access more volume. But I don't think it's like a light switch. I think it's a steady build over the first few quarters of 2025, particularly as people got to work through their resets in Q1, the plan resets and those things and those dynamics affecting how quickly that ramps. But I do think throughout 2025, we'll be able to see that Part D volume really pick up over time.

And then in terms of retreatment, again, I think it is really early to speak to this. But in terms of the payer dynamic, we don't expect any pushback from the payers because, again, a lot of these are very spaced out. Obviously, in all of our contracting discussions with payers, we built that thought process in that there could be up to a couple of treatments a year for a patient, and it's still a great value for the payer, right? Even at 2 treatments per year, it's a tremendous value and the effectiveness is proven. And quite frankly, the great story here is that if a patient is getting retreated, it's because the doctor thought they had a great response. So you're not treating patients that are not working. You're actually typically treating patients where you had a great response. So the effectiveness is proven, the value is there. So we've worked that into our negotiations and discussions with payers.

[Operator]

Our next question comes from Cory Jubinville with LifeSci Capital.

[Cory Jubinville, analyst]

Congrats yet again. This one has been quite exciting to watch. One from us. You mentioned in your prepared remarks that you've now reached 13,000 ECPs out of that original target of 15,000. Curious as you approach those treatment goals or target goals, what's kind of next in terms of the goals for your sales force? Is the future to really expand even further beyond that 15,000 into prescriber segments that might be less overlapping? Or is it more sort of concentrate on the rate of repeat prescribers? We've seen that increase quarter-over-quarter up to about 70%.

And I guess as a follow-up to that of that prescriber base, 70% are repeat prescribers. But do you have a sense of what percentage of those prescribers fall within this prolific prescriber category or those that might have made it beyond that initial 5 to 10 script trial period? And then a follow-up from us on repeat prescribers after.

[Aziz Mottiwala, executive]

Great. Thanks, Cory. Yes. So I think we're really pleased with the physician adoption. I said this from very early in the launch that one of the most remarkable things here is how quickly physicians in the eye care space are adopting XDEMVY. And I think this speaks one, to the market need and two, to the great results they're having with the product.

As we look forward, yes, we're really close to that total target of 15,000 doctors. Our focus is really shifting towards depth of prescribing, getting this existing prescriber pool to write with more frequency, looking for these patients more often and putting pen to pad more often.

So that's where a lot of our focus is going to be. And I think you're seeing that because not only did we increase the number of prescribers, but we also increased the percentage of repeat prescribing. And then to your point, we do look at this by segment.

How many are writing x number a week? How many are writing on a daily basis, et cetera. It's a little early to share those metrics, but I do think that's the goal of the sales force expansion we put in, right, is how quickly we can progress this 13,000 prescriber base to doctors that are writing on a daily basis, on a weekly basis and treating multiple patients because we know even our top prescribers, and as Bobby mentioned, we were at conferences this past few weeks and even our top top prescribers have not capped out. They're telling us they're only treating a proportion of their patients.

So as you can imagine, as DTC kicks in, as this expanded payer coverage kicks in, it's going to really open up the opportunity for these physicians to treat even more patients. And we think that that depth of prescribing, that frequency of visit from our sales force is really going to help potentiate that further. So more to come in terms of the metrics there, but you're spot on.

Our focus going forward is taking that prescriber base and increasing that frequency of prescribing.

[Cory Jubinville, analyst]

And on patient retreatment, from the field, what have prescribers been reporting back to you in regard to their plans for patient retreatment? And I guess on the flip side, how are you presenting the idea of retreatment to them and pitching that?

[Aziz Mottiwala, executive]

Right. So I'll start with the second part of that. When we are talking to the doctors, we remind them of what we saw in the clinical studies, which is at about month 12, 40% or so of the patients do recur, and we remind them of the biology of the disease, right, that XDEMVY is very effective at getting rid of mice on the eyes, but mice live on other parts of the body, and they eventually migrate back to the eye. So that's a key part of our messaging to physicians around the disease education, right, that this is a chronic disease that will come back post treatment at some point.

In terms of how the physicians are going to react, we hear a few different things. You hear doctors that are very proactive, that are going to write the first script and then instruct the patient to come back in 6 months, and they're going to proactively treat.

And then you hear some doctors that are going to wait for the patient to come back with complaints. That might be at the annual exam or it might be at a subsequent follow-up. So thus, it is a little early to see how this is going to progress over time. But I think you're going to see a spectrum of doctors as you would, right? Doctors that are going to be very proactive about keeping the disease at bay and then other doctors are going to react to when the disease comes back and then, of course, reach back to XDEMVY because it's been effective in the past.

[Operator]

Our next question comes from Francois Brisebois with Oppenheimer.

[François Brisebois, analyst]

Sorry for the background noise. Not to put Dr. Yeu here on the spot, but I was just wondering if you can maybe discuss a little bit what -- I know you were always involved with Tarsus, but why the move now to join as CMO? Is this -- how do you view the launch and the future potential of XDEMVY? And then I have 1 follow-up.

[Elizabeth Yeu, executive]

Thank you, Francois. I have been working with Tarsus now for 4 years, first as a core adviser, and it's been wonderful. And then for the past 3 years as a Board member. And in my time working with Tarsus, I mean, I've really seen how they've demonstrated true excellence in its mission to create transformative medicines.

And XDEMVY is a great example of this from pre-launch with all its execution with high-quality clinical evidence that's been generated thus far, how they've really elevated disease state awareness and right now, we're in the midst of a commercial launch that is being executed with laser precision.

And as you can see, Tarsus has a very cohesive leadership team that I've been fortunate to work with. They have deep biotech and eye care experience and it really is inspirational. But ultimately, for me, it's about taking care of patients and I've had that good fortune of being able to do it for 2 decades. And now I'm able to -- with leading the medical arm of this organization, I can amplify and scale my abilities to care for patients.

[Bobak Azamian, executive]

And, Frank, sitting next to Liz here is a privilege. And when we talk about evidence and education, 2 areas that Liz will lead, I think it just couldn't be a better time for her to join and really lead in educating more and more doctors with great evidence. So really proud to call Liz now a colleague in the executive team.

[François Brisebois, analyst]

That's great. And then maybe one last one that I don't think has been brought up, but MGD obviously gives you another touch point. It seems like doctors are very responsive to the sales team. But I was just wondering, any thought as you guys are doing well here about M&A? And if so, would it be -- are we sticking to ophthalmology? Are we seeing back of the eye, front of the eye? Just any color on M&A would be helpful.

[Bobak Azamian, executive]

Yes. No, I appreciate that question. I mean, part of the reason I'm excited for Liz to join us is it really is a step toward becoming an eye care leader. And when I think about what we can achieve in Tarsus, I think about 2 things. I think first off, we've got an incredible medicine in a space that hasn't had a blockbuster in a long time. And also think about the great team we have that can do everything from development to commercialization.

And so when you think about us over time, adding assets, I think you should look at development stage opportunities where we can lead and create categories. And you should also start to think about, as we are, commercial opportunities where with our platform that's leading now in eye care, we can add more to that bag, serve more patients, serve more doctors. So stay tuned and know that our focus is on XDEMVY squarely, but we are spooling up the wheels to be prepared to broaden our ultimate ability to serve patients.

[Operator]

This concludes the conference. Thank you for your participation. You may now disconnect.