Tarsus Pharmaceuticals, Inc. (TARS) announced robust third-quarter results for 2024, with a record $48 million in net product sales for XDEMVY, an eye care treatment for demodex blepharitis (DB) and meibomian gland disease (MGD). The company has expanded its sales force and secured extensive commercial and Medicare coverage.
Tarsus also aims for FDA approval of two additional treatments by the end of 2024 and expects European approval for XDEMVY by the second half of 2027. Financially, the quarter was strong with $48.1 million in net sales, 41,400 bottles dispensed, and a cash reserve of $317 million. The company expects to dispense up to 55,000 bottles in Q4 2024 despite seasonal headwinds and remains optimistic about continued growth.
Key Takeaways
- Record $48 million in net product sales for XDEMVY with over 41,000 bottles delivered to patients.
- Sales force increased from 100 to 150, leading to higher prescribing rates among eye care professionals.
- Over 80% coverage secured through commercial and Medicare contracts.
- Direct-to-consumer campaign launched and strategic shift towards data dissemination.
- Anticipated FDA approval for two new treatments and European approval for XDEMVY without a Phase 3 study requirement.
- Strong Q3 financials with $48.1 million in net sales and $317 million in cash reserves.
- Operating expenses were approximately $73.3 million.
- A 20% capture rate over time is expected, with a focus on educating physicians and expanding market share.
Company Outlook
- Tarsus anticipates further growth as it continues to educate eye care professionals and patients.
- Plans for more data dissemination and potential expansion into international markets.
- A strategic shift towards enhancing patient access to XDEMVY is expected to increase the patient population by over 20%.
- Tarsus is optimistic about capturing a larger market share as it navigates market dynamics.
Bearish Highlights
- IQVIA data shows fluctuations up to 10%, causing uncertainty in precise capture rates.
- Seasonal headwinds expected to affect bottle dispensing in Q4.
- Doctors visiting offices less frequently may challenge Q1 2025 performance due to deductible resets and patient influx.
Bullish Highlights
- Significant clinical improvements observed with XDEMVY, including a 51% enhancement in meibomian gland secretion.
- Substantial reductions in symptoms like fluctuating vision and itching reported.
- Strong commercial and Medicare Part D coverage, with over 80% of lives covered.
- The company expects minimal pushback from payers regarding patient retreatment patterns.
Misses
- Despite strong sales, operating expenses remain high at approximately $73.3 million.
- The effectiveness of new sales representatives and the impact on treatment initiation are still being evaluated.
Q&A Highlights
- The management discussed the Medicare donut hole impact, expecting a smoother effect in 2025 due to new out-of-pocket caps.
- Gross to net adjustments are expected to stabilize around a 42% to 43% discount by mid-2025.
- The company is investing in understanding European reimbursement dynamics and is preparing for potential seasonal impacts on sales.
- Tarsus is focusing on increasing the depth of prescribing among existing prescribers and is optimistic about M&A opportunities in ophthalmology.
Dr. Elizabeth Yeu's transition to Chief Medical (TASE:PMCN) Officer (CMO) and the addition of Dr. Kate Goodrich to the Board of Directors were highlighted as strategic moves to enhance the leadership team. The company is committed to expanding its offerings while keeping a strong focus on XDEMVY's growth and market presence.
InvestingPro Insights
Tarsus Pharmaceuticals' (TARS) strong third-quarter performance is reflected in several key metrics from InvestingPro. The company's revenue growth is particularly noteworthy, with InvestingPro data showing a remarkable 566.99% increase in the last twelve months as of Q2 2024. This aligns perfectly with the record $48 million in net product sales for XDEMVY reported in the article.
InvestingPro Tips highlight that Tarsus "holds more cash than debt on its balance sheet" and "liquid assets exceed short term obligations." These factors contribute to the company's solid financial position, supporting its $317 million cash reserve mentioned in the article. This strong liquidity position enables Tarsus to fund its expansion plans and invest in future growth initiatives.
Another relevant InvestingPro Tip indicates that analysts anticipate sales growth in the current year, which corroborates the company's optimistic outlook and expectations for continued growth in XDEMVY sales. The tip suggesting that Tarsus is "trading near 52-week high" (with the price at 92.85% of its 52-week high) further underscores the market's positive reception of the company's recent performance and future prospects.
It's worth noting that while Tarsus is experiencing significant growth, the InvestingPro data shows an operating income margin of -187.55% for the last twelve months as of Q2 2024. This reflects the high operating expenses of $73.3 million mentioned in the article, indicating that the company is heavily investing in its growth strategy.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for Tarsus Pharmaceuticals, providing a deeper understanding of the company's financial health and market position.
Full transcript - Tarsus Pharmaceuticals Inc (TARS) Q3 2024:
Operator: 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. Thank you.
David Nakasone: Before we begin, I encourage everyone to go to the investor 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 three, 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.
Bobby Azamian: 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 am 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 extend XDEMVY and DB patients. These repeat visits, combined with ease of access and shared evidence, are accelerating that prescribers 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 dataset 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 two remaining large Medicare contracts, bringing total covered lives to more than 80% a remarkable statistic this early in the launch in. Turning to our world class leadership team, you may have noted that we added two 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 Advisor 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 two 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 (NYSE:HUM) 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 in our commercial progress. Aziz, over to you.
Aziz Mottiwala: 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 healthcare, 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 salesforce, 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 digits from a sales rep to convert an ECP from XDEMVY trial list 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 you write XDEMVY five or more times per week, which speaks to the depth of prescribing we are 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 two 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 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 session 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 suggest 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.
Sesha Neervannan: Thank you, Aziz. It gives me great pride to see the impact of XDEMVY on patients and the potential of a 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 Rare 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 [indiscernible] 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 externally 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 we 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 us 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 Europeans Medicines Agency or EMA, who informed us that in addition. Phase 3 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 TPO 4 for rosacea and TPO 5 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.
Jeff Farrow: Thanks, Sesha. Q3 marked our strongest quarter to date, highlighted by $48.1 million in extending net product sales, more than 41,400 bottles dispensed to patients, a gross net discount of approximately 40% and securing additional commercial and the two 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 salesforce 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 growth 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 genetic rules 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 one to two 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 salesforce, our new DTC campaign and other extended 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.
Bobby Azamian: 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].
Bobby Azamian: Before we take the first question, I just want to make a few points highlighting the great quarter in progress to come. First, we're already seeing great growth from our strategic levers of education, 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 winds. 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: Thank you. Our first question comes from Eddie Hickman with Guggenheim.
Eddie Hickman: Congrats on a really great quarter. Just a few questions from me, will the MGD expansion that you're planning require another salesforce 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? Thanks.
Aziz Mottiwala: Hey, Eddie, this is 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 fall panel that we have with our salesforce. So we're able to reach all these doctors. You can 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, 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: Thanks for that. Just one 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, it'll sort of maintain in that range. Thanks.
Jeff Farrow: Hi, Eddie. It's Jeff, and as we've always cautioned, IQVIA is imperfect data at best, in its 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 weeks here.
Operator: Our next question comes from Lachlan Hanbury-Brown with William Blair.
Lachlan Hanbury-Brown: 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?
Jeff Farrow: Sure thing, thanks for the question. Obviously, with the sales reps, we look at a myriad of different metrics. You know, 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 salesforce is out there toward the very end of Q3 and I think we started off Q4 with really great momentum with that expanded salesforce 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: Got it. Thanks, 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 need, not providing '25 guidance, but is there any commentary you have on maybe just like the cadence of the donut hole over 2025 of those changes?
Jeff Farrow: 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. You know, 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 on the back half of the year. Our current expectations is it will probably see it more evenly spread throughout the years, instead of these sort of peaks and valleys.
Operator: Our next question comes from Andrea Newkirk with Goldman Sachs.
Andrea Newkirk: Thanks for taking the questions. 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 populations of 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?
Sesha Neervannan: Thanks, Andrea. This is Sesha. I'll take that question. Thank you for that. You know. So the study that we did was focused on MGD, who have DB patients. And so the data strongly, 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 extend be to treat DB and in MGD patients. At this point, we because the data is so compelling, and we have, as Aziz mentioned earlier, significant segment of the patient 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.
Bobby Azamian: And I just want to add on that, having been at, you know, the academies recently and talked to a number of physicians, there's 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 go
Andrea Newkirk: And then Jeff, maybe one 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. Thanks so much.
Jeff Farrow: Sure. We looked at some traditional analogs in the eye care space, and that's why we initially estimated, you know, 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, 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, sometimes starting in the middle of, say, 2025
Operator: Our next question comes from Oren Livnat with HC Wainwright
Oren Livnat: Thanks for taking the question 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 a reduction in perhaps bridging supply or free drug that's maybe going to previously uncovered patients. Is that coming out of SG&A now, you know, maybe if it was previously almost like sampling. So we're seeing that benefit in Q3 already, kind of a follow up. Thanks.
Bobby Azamian: 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, you know, 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 ETC campaign ramping up. And then, of course, we'll have the full quarter impact of the sales force at that point.
Oren Livnat: 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 category creating product in eye care and in Europe, should we assume that that's going to be more favorable than the extreme compression on pricing we've seen in other eye care products that are in competitive markets relative to U.S. pricing?
Aziz Mottiwala: Yes when we look at Europe, we see a couple 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's 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 patient 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 to value provides 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.
Operator: Our next question comes from Balaji Prasad with Barclays (LON:BARC).
Balaji Prasad: Hi, good evening, and thanks for the questions. Couple from me. Firstly, could you with around one 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 at summer holidays being called out. So how should we think about broad seasonality during the 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 an incremental impact with the salesforce? Thank you.
Bobby Azamian: Great. I'll start on the question on seasonality. I think Balaji I think, you know, while it's still, you know, you're in relatively early as we're continuing to build this market, I think there's a couple of things that that we do know, right? We do know that what we saw over the summer was a little bit of slowing we saw, you know, 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 looked at 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 two areas to look for, you know, 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 two big things that I think about, first quarter recess 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.
Sesha Neervannan: Yes, thanks, Balaji. So as Bobby mentioned, you know, we got really positive feedback from all the conferences, and as we continue to hear more 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 segments with contact lens intolerance that could 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--
Operator: Our next question comes from Jason Gerberry with Bank of America Merrill Lynch (NYSE:BAC).
Jason Gerberry: Hey guys, thanks for taking my questions. A couple for me, just on the part detail ones [ph] trying to think about that going into next year. I guess the previous assumption was that, you know, 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.
Bobby Azamian: And in terms of Part D, I think, you know, I 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 auth, etc. 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 it worked through their recess in Q1 the plan resets it, 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 B 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 two 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's getting retreated 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 of proven the value is there. So we've worked that into our negotiations and discussions with payers.
Operator: Our next question comes from Corey Jubinville with Life Sci Capital.
Corey Jubinville: Congrats yet again, this one's been quite exciting to watch. You know, one from us you mentioned 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 15k into prescriber segments that might be less overlapping, or is it more so to concentrate on the rate of repeat prescribers, we've seen that increased quarter over quarter up to about 70%. And I guess as a follow up to that, you know 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.
Bobby Azamian: Great. Thanks. Corey, yeah, 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 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, yeah, 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, 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 this salesforce expansion we put in right is how quickly we could 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.
Corey Jubinville: And on patient retreatment. You know from the field, what if prescriber What if 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
Bobby Azamian: Right. So I'll start with the second part of that. When we are talking to the doctors, we remind them what we saw in the clinical studies, which is at about month 12, 40% or so the patients do recur, and we remind them of the biology of the disease, right? That XDEMVY is very effective at getting rid of mites on the eyes, but mites live on other parts of the body, and they eventually migrate back to the eyes. 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 six 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 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 towards XDEMVY because it's been effective in the past.
Operator: Our next question comes from Francois Brisebois with Oppenheimer.
Francois Brisebois: Hi. Thanks for the question. Sorry for the background noise. Not to put doctor on you on the spot, but I was just wondering if you maybe discuss a little bit. You know, what a try. I know you were always involved with Tarsus, but you know what? What? Why the move now to join as CMO, you know, how do you view the launch? And you know, the future potential of XDEMVY. And then I have one follow up.
Elizabeth Yeu: Well, thank you, Francois. I have been working with Tarsus now for four years, first as a core advisor, and it's been wonderful. And then for the past three 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 medicine 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 two 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.
Aziz Mottiwala: And Frank, sitting next to Liz here is a privilege. And you know, when we talk about evidence and education, you know two areas that Liz will lead, I think it just couldn't be better time for her to join and really lead in educating more and more doctors of great evidence. So really proud to call Liz now a colleague and an executive.
Francois Brisebois: That's great. Thank you. And then maybe one last one that I don't think has been brought up, but you know, MGD obviously gives you another touch point. It seems like doctors are very responsive to the sales team. But I was just wondering any thoughts, as you guys are doing well here about M&A, and if so, would it be, you know, are we sticking to ophthalmologys? Are we seeing back of the front of the eye, just any color on M&A would be helpful? Thank you.
Aziz Mottiwala: Yes 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 two things. I think, you know, 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 our doctors. So stay tuned and know that our focus is on XDEMVY the squarely, but we are spooling up the wheels to be prepared to broaden our ultimate ability to serve patients.
Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect you.
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