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spk13: Good day, and thank you for standing by. Welcome to the Arcutis Biotherapeutics second quarter 2023 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your speaker today, Eric McIntyre, Head of Investor Relations. Please go ahead.
spk02: Thank you, Corey. Good afternoon, everyone, and thank you for joining our QDSIS second quarter earnings call. Slides for today are available on the investor section of our website. On the call today, we have Frank Watanabe, President and CEO, Ayesha Jeter, our Interim Chief Commercial Officer, Patrick Burnett, Chief Medical Officer, and Scott Burrows, Chief Financial Officer. I'd remind everyone that we'll be making forward-looking statements during this call. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to review the information disclosed in our latest SEC filings. With that intro, I'll hand the call over to Frank.
spk05: Thanks, Eric. And I'm going to make some brief introductory comments, and then I'll turn it over to the experts here. So I'm on slide five of the slide deck. I'm really proud that our team is effectively executing on our strategy. to build the leading innovation-driven dermatology company. The Zareve launch is strengthening on all fronts, laying a solid foundation for sustained long-term growth. Physician and patient feedback remains exceedingly positive, and the launch is building momentum. We're really encouraged by our script growth as clinicians gain positive real-world experience with Zareve, and in Q2, we saw around 40% growth in TRXs versus Q1, and we've seen even further growth so far in Q3. And remember, we're just scratching the surface here on the broader topical steroid opportunity, which is still roughly 20 times the size of the current non-steroidal market. One key element to unlocking the long-term conversion from topical steroids is our success in obtaining broad, high-quality access, and we're thrilled to have announced the CVS coverage decision in early July. In less than 12 months from launch, we've now secured coverage at all three of the large national PBMs, as well as other large downstream health plans, which is unusually fast for any launch, and we think is validation of our pricing and access strategy. Currently, more than 130 million commercially insured patients have access to Zareve, and over 90% of those patients have access without any prior authorization, which meets our goals for high-quality access. I'm also pleased to report that gross to net has improved in the second quarter, as we had previously indicated. And so far in Q3, we are seeing additional improvement, in part due to the expanded coverage, as well as our focused execution, with a percentage of scripts being covered reaching all-time highs, and we expect further gross net improvement in Q3 and additional improvement in Q4. Beyond the Zareve US launch, we're also executing to build for the future. In June, we launched Zareve in Canada, and thus far we've had an excellent reception from physicians and patients, as well as rapid progress in building the same high-quality access that we've achieved in the U.S. It's still early days, but the script growth has been healthy, and we've already secured coverage for Zarev with the top three private payers, representing more than half of the Canadian private market. We also strengthened our overall patent estate with the recent issuance of a new patent covering methods of treatment of seborrheic dermatitis with reflumilase foam, and that's a U.S. patent, by the way. We already enjoyed very strong IP protection on topical reflumelast foam and cream through 2037, and this new patent extends protection for the foam in seborrheic dermatitis through 2041, which we're obviously delighted with. So, turning now to slide six, you know, we've shown this slide previously, but I think it's a good reminder of the true opportunity for topical reflumelast and also what makes it a very unique molecule with potentially four products in one as we execute multiple launches in the quarters ahead. With Zareve today, we're competing in a market of about 2 million patients topically treated for their psoriasis in U.S. dermatology offices. Then we have potential upcoming launches every two to three quarters with Cevderm at the beginning of 24, AD in the second half of 24, and then scalp and body psoriasis in 2025. We also have a very large opportunity outside of the dermatology office, particularly with the expected approvals in atopic dermatitis and seborrheic dermatitis, both of which are frequently treated in a primary care setting. As we've indicated before, we do not intend to build our own primary care sales force, but we'll look for a partnership to help us access this market in a cost-effective way. So when you factor in all those opportunities we're pursuing, both inside dermatology and out, that's a 13 million patient addressable market and more than a six-fold increase over the current psoriasis market we're competing in. Now I want to turn the call over to Ayesha Jeter, our interim chief commercial officer, to provide more details on the Zareve launch. But before I do, I want to comment on how impressed I've been with her performance as our interim CCO over the past few months. I had no doubt about Ayesha's ability to fill in as an interim CCO when we appointed her to that role, and she's done incredibly well filling in while we search for a permanent chief commercial officer. She's providing strong leadership, and our commercial team has not missed a beat, as you can see in our recent sales performance. And with that, Aisha, go ahead.
spk11: Thanks, Frank. Moving to commercial performance on slide eight. We are proud of the growing momentum across all aspects of our launch. Everything starts with Zareve's strong product profile at the core, which continues to pay dividends with patients, physicians, and payers. We are seeing steady prescription growth as more clinicians gain experience and determine in the real world how Zareve can perform for a variety of their patients. As we've said in the past, to successfully launch drugs, companies need to constantly evaluate tactics and adjust as needed, and our team is doing just that. Our results in Q2 reflect our ongoing adjustments and improvements, and we will look for ways to further optimize our performance going forward. On this slide, we're showing IQVIA demand data. Now approaching one year into launch, we see healthy, consistent growth trends with nearly 40% TRX growth quarter over quarter in Q2, plus further growth in the third quarter to date, surpassing all-time highs in both TRX and NRX post the Fourth of July holiday. HCP and patient feedback on Zareve's performance in the real world remains exceptional, especially its rapid efficacy with the once-daily treatment that can be used anywhere on the body, the ability to use it in endotrigenous and sensitive areas, as well as very positive feedback on its effectiveness in treating the most difficult plaques in areas like elbows and knees. And, of course, clinicians and patients really appreciate the favorable tolerability profile of Zareve as well. Moving to slide nine, since launch, we've made great strides in unblocking broad, high-quality access for Zareve that will drive further patient demand and growth to net improvement. As Frank mentioned, Zareve is now covered on the top three largest commercial PBMs on their national formularies, which gives HCPs peace of mind about how easy it is for their commercially insured patients to obtain Zareve. With over 130 million commercial lives now covered, we have secured access for 80% of commercial lives in the U.S. With this broad coverage, HCPs don't have to think about where Zareve may or may not be reimbursed. Importantly, of that 80% of commercial lives, over 90% are covered without a prior authorization, which reduces the hassle factor that typically limits prescribers from putting pen to paper. We believe this distinction, along with our product profile, is critical to facilitating the long-term conversion from topical steroids. We also expect that the high-quality coverage enjoyed by Zareeb will also help with our expected launches in seborrheic dermatitis and atopic dermatitis in 2024. On slide 10, the slide details our broad, high-quality commercial coverage for Zareeb on the national formularies of the three largest PBMs. Payers are responding favorably to Xere's clinical profile with the most recent example being CVS not requiring a step for patients with psoriasis in sensitive areas. Certainly a nod to our differentiated label and aligned with what is best for these patients in practice. Our pricing and access strategy is resonating with payers as evidenced by a growing number of instances where we have an advantage in utilization management criteria, preferential tier status, and certainly our time to coverage compares favorably to other recently launched branded topical agents. We're also making progress with coverage outside of the commercially insured population. The VA just recently updated its clinical guidelines where we see another example of payers valuing the clinical profile of Zareve. Like CVS, there is no step requirement for patients with plaques in sensitive areas, and the VA also imposed a requirement to step through Zareve to get to the other new branded non-steroidal. As we said all along, this differentiated high-quality coverage ultimately makes Zareeb less burdensome for healthcare providers to write, which is critical to converting the topical steroid market over the long term. Additionally, we're also starting to see benefits of our improved coverage and focused field execution on our growth to net. Our field reimbursement team is now fully on board. We have further fine-tuned our co-pay offerings and our sales team is making positive stride in pulling through covered prescriptions. We have the right plan and tactics in place and are executing against that. In Q2, we saw improvement in the percentage of prescriptions covered, and that improvement has accelerated in Q3. In fact, in July, we've seen our best month yet in terms of covered prescriptions, giving us confidence in our plans and team's execution. We are seeing improvement in the percentage of covered prescriptions across all major PBMs. Most notably, since the CVS coverage decision in early July, we have seen a more than doubling in the percentage of prescriptions reimbursed by CVS. We expect our improved coverage coupled with filled force execution to produce improved growth to nets in Q3 with further improvement in Q4, which reinforces our conviction that we can achieve our target steady state growth to net over time. On slide 11, I will remind you all of the three pillars to commercial success that we set out for sustained Zareve growth. First, driving HCP awareness and expanding the prescriber base. we have now seen over 7,500 unique riders since launch. We remain focused on increasing our reach and frequency with the highest prescribing healthcare providers. At the same time, there is still a lot of headroom for further expansion of providers, and we're actively targeting those HCPs who have yet to begin prescribing the newer non-steroidals. Second, patient engagement and experience. Refills are growing very nicely. In Q1, we averaged approximately 20%. It increased in Q2 to 27%. And for the month of July, our refills were approximately 33%. Sustained growth here is important to achieve the long-term potential of Zareve and also is an encouraging indicator of patient adherence to Zareve. We previously said that we would look at enhancing our DTC efforts as access comes on board more broadly. With our recent progress on coverage, we feel the time is right to fuel the next leg of the Zareve launch into 2024 and beyond. And as a result, we will be going live with a focused, connected TV campaign later this quarter, which will activate patients to ask their dermatologist for Zareve. In closing, we look forward to delivering on the long-term promise of Zareev. And with that, I will hand it over to Patrick.
spk17: Thank you, Aisha. From my end, I just wanted to provide a quick update on our near-term clinical and regulatory milestones, and these are on slide 13. These all remain on track, building significant sustained long-term growth potential, as Frank mentioned earlier. So starting off with Atopic Derm, we have the integument peed readout on track for later this quarter. And as a reminder, this study is in the two to five-year-old AD population. We also look forward to submitting the SNDA in late Q3, early Q4 for atopic dermatitis for ages six and above based on the integument one and two positive readouts. Journey to seborrheic dermatitis, we have our PDUFA set for December 16th. And HCP excitement is already incredibly high And right now we're doing a lot of disease state awareness with the medical team in the field. Briefly on psoriasis, we look forward to the potential approval for a label expansion for Zurich down to the age of two in the fourth quarter. And this builds on our existing label for adolescents and adults in psoriasis. And one additional update on the early pipeline recall that we started a phase one B study with our unique topical Jack for alopecia areata initially in healthy volunteers, And now we've progressed to enrollment of our first alopecia areata subject in that study. We'll have more to share on this study as it nears enrollment completion. With that, I'll turn it over to Scott.
spk04: Thanks, Patrick. Turning to page 15 of the slide deck, total revenues were $5.2 million in the second quarter. Net product revenues were $4.8 million, driven by nearly 40% quarter-over-quarter demand growth, as well as improved growth to net. Recall we communicated in our last earnings call that we expected most of our second quarter growth would be driven by demand, but we are pleased to see gross-to-net improvements meaningfully contributing to revenue growth as well in Q2. Based on the expanded insurance coverage that Aisha highlighted, as well as our efforts to ensure prescriptions are appropriately processed as covered prescriptions, we expect further gross-to-net improvement in Q3 and continued improvement in Q4. In the second quarter, we also recognized $400,000 in other revenues, which was the value of an equity stake received from a previous collaboration partner. Turning to the rest of the P&L, research and development expenses were $25 million in the second quarter. The decrease year-over-year is primarily due to lower clinical development costs as we wind down our topical reflumilast programs. In addition to lower reflumilast development costs, The comparison versus the first quarter also benefited from the $3 million seborrheic dermatitis FDA filing fee in the first quarter, some one-time favorable clinical study true-ups, and our broader efforts to reduce spend in our early-stage R&D programs. For Q3, we would expect R&D to tick back up closer to $30 million, as we do not expect the same one-time favorability from study true-ups. We expect a further step down in R&D expenses in 2024. SG&A expenses were $46 million for the quarter, reflecting our continued investment in the Zareve launch and the upcoming launches in seborrheic dermatitis and atopic dermatitis. As Aisha mentioned, we will begin our focused, connected TV efforts later this quarter and into Q4, driving some additional SG&A expense growth. Net loss per share was $1.16 for the quarter, compared to $1.31 in the same quarter last year. Turning to our final slide on page 16, We provide some key balance sheet and cash flow items. We remain well capitalized with cash of $270 million as of June 30th. Our burn decreased in the second quarter, driven by lower R&D costs and the timing of certain payments. Similar to my operating expense comments, we would expect cash burn to tick back up slightly in the third quarter as we invest in the psoriasis and upcoming seb derm launches. Over time, we'd expect a general downward trend in quarterly cash burn as revenues continue to grow and as we benefit from sales across multiple indications. We also remain confident in our near-term ability to further strengthen the balance sheet with non-dilutive capital through our ex-US health licensing efforts. This concludes the financial update. I'll now turn the call back to Frank.
spk05: Thanks, Scott. So, just in closing, first of all, I would like to thank all the members of the Arcutus team for As you can imagine, folks are working incredibly hard to deliver these results, and I am constantly impressed by the dedication of our team. I also want to thank every one of you for taking the time out of your day to call in on our quarterly earnings call. And with that, we will wrap up and open things up to questions and answers.
spk13: Thank you. We will now conduct a question and answer session. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from Tyler Van Buren of TD Cohen. Your line is open.
spk12: Hey, guys. Good afternoon. It's great to see the improvement in coverage that occurred over the last quarter. And you mentioned the percent of covered prescriptions are at an all-time high. So, the first question is, what was the percent of covered prescriptions during Q2? and July separately relative to Q1. And then for a second question, which is kind of related, but just for additional detail on the quarter, can you talk about the cadence of improvement of gross to net during Q2? I presume May and June were better than April as the second PBM came online on May 1st. But as we think about the trajectory heading into Q3, was the gross to net during June significantly improved relative to May?
spk05: So, Tyler, thanks for your questions. Maybe I'll take the first one, and then I'll ask Ayesha to go into a little more detail on your second question. In terms of percentage-covered prescriptions, that's a level of detail that we probably aren't comfortable really getting into, but I will say that we are seeing a steady trend upwards every quarter in the percentage-covered, and that includes, as I mentioned earlier, since the end of Q2, we've seen further improvement. Ayesha, do you want to maybe talk about what we saw within the quarter in terms of the cadence of improvements?
spk11: Sure. So first off, what I would note is that as it relates to, there was a couple of different components. One was the deductible resets. We did start to see an improvement there as patients actually got through their deductible. Secondly, as it relates to PBM number two coming on board, once that implementation was in place, we saw improvement. And then further thereafter, then we started to see some improvements with the pull-through related to the reimbursement field team.
spk14: I think, Corey, we can go to the next question.
spk15: One moment for our next question. Go ahead, Corey. Corey, go ahead. Our next question comes from Vikram Porhot of Morgan Stanley.
spk16: Hi, good afternoon. Thanks for taking our questions. We had two both on Dereave and psoriasis. First, could you just provide a bit of color on how the mix of patients being prescribed Dereave might be changing over time since the launch in terms of line of use, prior treatment status, things like that. And then secondly, back to gross to net, but taking a step back, what's your current thinking on what a steady state gross to net could look like? And what do you think your timeline is for getting there? Thanks.
spk05: Yeah, so maybe I'll take the second one, then I'll ask Aisha to talk about mix of patients. Although, you know, I will say, you know, our granular in that data is, you know, isn't perfect, but You know, I think we've continued to say that we remain confident in our ability to get to a steady state gross net and somewhere in the 40 to 60% range. And, you know, we still believe that today, particularly with the improvement that we're seeing in Q2 and in Q3. You know, I think it's probably going to take us a little bit longer to get there than what we had initially anticipated. But certainly we think that's well within our reach. You know, the exact timing I think is really difficult to predict. you know, we're in, I think, a somewhat unusual circumstance that, you know, we're launching multiple products in the same window of time before we get to steady state, you know, with the expected seb derm launch in early 24, and then AD in mid 24, and then scalp in early 24, sometime in 25. And, you know, every time you launch a new product that has impact on your growth to net trend. So I think it's difficult at this point for us to say exactly when we will get to a steady state. You know, I said before, it certainly won't be in 23, but I also don't think it's going to be, you know, 2028. But at this point, I think it's too early to call, and we'll update you guys as we get more clarity going forward on that. Ayesha, can you maybe talk about the mix of patients that we're seeing?
spk11: Absolutely. So, Vikram, as it relates to the patient, so first off, it's similar to what we've discussed in the past. First, it's the patients that have tried a steroid and or other topicals, and then also it's been a mix of patients that have tried a single steroid for the most part.
spk05: Thank you. I just add just as a reminder, you know, in any given year, you know, 95% of psoriasis patients are continuing patients. There's not a huge amount of new patients coming into the system every year. And so, you know, most patients have been on something previously for their plaque psoriasis. Sure. Understood.
spk16: Thank you.
spk13: Thank you. One moment for our next question. Our next question comes from Seamus Fernandez of Guggenheim Securities. Your line is open.
spk03: Great. Thanks for the question. So, just two quick questions. Can you guys help us understand the number of accounts that you are currently in and marketing to at this point in time? Just trying to get a better sense of that. Some of the survey work that we've done has shown actually pretty strong penetration among physicians and users of both Dereave and Vitama with good growth expectations. for their internal use, but it seems like the kind of growth that that would deliver if there isn't a lot of additional growth in the practices that you're promoting to that, you know, it really is kind of practice growth and greater experience that's going to drive script growth for Zareeb. And then separate and incremental to that, Can you just help us understand whether you believe you're fully resourced with the current sales force and kind of the marketing efforts to launch the foam once the seb derm indication is approved? Thanks.
spk05: Sure. Seamus, when you say accounts, you're talking about physician accounts, right? Correct. Yeah, yeah, exactly. So, you know, I think Aisha mentioned on the call that right now about 7,000 unique physicians have prescribed Xareeb, and that's out of about 13,000 targets. So, you know, there's still quite a bit of headroom in terms of bringing new doctors on to prescribing Xareeb. And then, you know, I think the other facet, and I made reference to this, you know, if you think about the size of the topical steroid market today being 20 times the size of the non-steroidal market, Even in those markets or those offices that have started to adopt, you know, Zareeb, there's still a great deal of upside in terms of deepening the prescribing base as well. So, you know, we think about growth as being both of those, both an expansion of the base as well as the deepening of the prescribing base. And, you know, I think, as I mentioned, I think in my introductory comments, we really think that we're just scratching the surface, particularly as, you know, I think the momentum around the move away from steroids builds in the dermatology community. And then with regard to your same question around resourcing for SAB Durham launch, maybe again, I'll ask Aisha to comment on that as CCO.
spk11: Absolutely, Frank. So as it relates to the resourcing, the team is well resourced from a Salesforce as well as a marketing perspective. Right now, we're hyper-focused on doing the disease state awareness education to providers and ensuring that it's more focused on not just providers, but more importantly, are to patients. So definitely feel very confident in the resources that we currently have right now to help us to accelerate our approvals, excuse me, not approvals, our launch for seborrheic dermatitis.
spk14: Great. Thanks for the questions.
spk13: Thank you. One moment for our next question. Our next question comes from Oyir of Mizuho. Your line is open.
spk08: Guys, thanks for taking my question. Just a quick one. Could you sort of, I don't know if it's probably too early, but can you kind of speak to the persistent rate? Like, I think you mentioned number, what is it, 33% refills or something, but are you seeing a lot more patients, you know, are patients also going off, you know, continuing to use the therapy or not? And I guess the second question, financially, I think, Scott, you mentioned that 2024, you're going to see a downturn. Could you sort of help us quantify that in terms of R&D spend? Thank you.
spk05: Yeah. Okay. Yeah. So, you know, in terms of persistence rate on Zareef, I think it's still, you know, very early days to gauge exactly what that is. You know, Aisha mentioned that that refills in July have grown now to 33% of total volume. And so we certainly have seen a steadily increasing number of refills from patients. You know, there are some patients who are refilling quite frequently. I think Ken previously mentioned, you know, that we've seen patients refill as many as five times. But, you know, I think that's really at the skinny end of the tail and bell-shaped curve. You know, we continue to think that it's probably something like three tubes a year And so, you know, the bulk of patients, you know, may be just coming up on their first prescription refill right now. But that's something that we'll continue to monitor. You know, in terms of discontinuation due to a lack of efficacy or due to side effects and tolerability, I think that's one of the really encouraging things we continue to hear from clinicians is that they very rarely, if ever, see non-response to Zareve, which I think is consistent with the data that we've shared in the past. where 95% of patients in our clinical trial improved on Zareed. And the side effect profile, what we hear anecdotally is that it's at least as good, if not better, than what's in the label. And again, in our long-term extension study, you probably recall, we saw about 50% higher adherence in our long-term study than what has been historically the case in topical trials. So we are definitely encouraged by the early signs around adherence. And then, Scott, can you maybe take the least question around the expenses?
spk04: Yeah. Yeah. Hi, O.A. So on R&D spend of 2024, I'd say it's a bit early to get too specific, but the key drivers would be, you know, we still have – Our pediatric AD study and our long-term extension study ongoing, that spend will reduce again in 2024. And until we're approved in SebDerm, some of our ongoing, for example, like manufacturing efforts, continue to hit the R&D line. So once that's approved, that will come out of the R&D line. And so those are kind of the key drivers that we'd expect going into 2024.
spk13: Okay. Thank you. Thank you. One moment for our next caller. Our next question comes from the line of Chris Shibutani at Goldman Sachs. Your line is open.
spk06: Hey, team. This is Steven on for Chris. Thanks for taking our question. Two from us. Can you help us characterize the physicians who have not yet prescribed Zoriv and how you think about gaining mindshare among that group of physicians to the extent that they're either they don't see the value in the product versus they haven't been adequately detailed to this point? And then our second question is, Can you just talk about why you think now is the right time to do TV marketing ads? I think you had talked previously about until you felt you had a sufficient level of peer coverage. So that would make sense. But yeah, I just want to hear your thoughts there. Thank you.
spk05: Yes, sir. Aisha, can you maybe take those two?
spk11: Yeah, absolutely. So I think as it relates to the prescribers that have yet, those prescribers that have yet to write Zareed, I think we do have to at first recognize that there are just ingrained habits that with providers that are using topical steroids. So our team is consistently going in and helping them to understand what the value proposition is of Zareeb and reminding them of the importance. Because as we have a reminder is that out there when you're talking to prescribers, those that have utilized Zareeb absolutely love and are bought in on the clinical profile. Now, secondly, as it relates to your question on DTC, you are correct that, you know, in the fact that we've been evaluating this tactic for quite some time, but we wanted to wait for our Zareeb coverage to be in place, and we are now at that critical mass where we feel great to go ahead and flip the switch and turn it on.
spk06: Perfect. Thank you very much.
spk13: Thank you. One moment for our next question. Our next question comes from Louise Chen of Cantor. Your line is now open.
spk09: Hi, thank you for taking my question. So I wanted to ask you on CEP Durham, what gives you confidence that you can build a greenfield opportunity here? Secondly, can you leverage any of the payer work you did for Zareeb and psoriasis for your atopic Durham opportunity? And then lastly, how do you think about a primary care partner? What would be an ideal company for you? And any thoughts on timing of when we might see something? Would it be this year, more likely next year, and beyond? Thank you.
spk05: Sure. So I'll address the PCP piece, and then I'll ask Aisha to talk a little bit about our thoughts around SebDerm. And then, sorry, excuse me. I think around SebDerm, I'm going to make sure Patrick's not asleep, and I'm going to ask him to talk about that as a clinician. Okay. And then we'll ask Aisha to talk about the coverage piece. You know, just with regard to the PCP partnership, you know, I think from a timing standpoint, you know, we've been saying consistently we feel like that is something that we really want to have in place around the atopic dermatitis launch, which, you know, is probably the second half of next year. You know, there could be a benefit to doing it earlier. Again, seb derm is often treated in the primary care setting as well. But, you know, but we didn't feel like we had to rush to get the partnership ready for Seb Derm. It'll contribute, I think, as we get momentum going. So yeah, I would look to something second half of next year probably is the most likely timeframe. And then in terms of the ideal partner, in an ideal world, it's a company with a very capable and large primary care sales force calling on both primary care physicians, internists, and GPs, as well as pediatricians who are seeing a lot of of the atopic dermatitis patients. And if there is a little bit of allergists in the mix, that would be great too, but I think that that's less critical just because of the sheer relative size of the three opportunities. I think for us, the most important thing is having someone who's very good at execution and someone who works well with our team. And then Patrick, can you maybe talk a little bit about the Sebderm opportunity and how much building we really need to do versus just stepping into an existing market?
spk17: Yeah, absolutely. I think one of the key things about seborrheic dermatitis patients is that they're already in dermatologists' office. And we heard this very early when we started talking to them, and it's been borne out by repeated ad boards and just more and more conversations. They have just as many seb derm patients in their office as they do psoriasis. And that's just people coming in. Keep in mind that there hasn't been a new drug for seborrheic dermatitis for decades. And so now we're going to be bringing a non-steroidal treatment that is really kind of the first opportunity for them as HCPs to be able to offer something new to their patients. For the entirety of most of their practice, they've been using topical steroids and antifungals in some combination And when a patient gets referred to them with seborrheic dermatitis, they've oftentimes been treated with these already, and now they don't really have anything new to offer them. So, you know, I think that's one of the reasons I mentioned that we have just very high HCP excitement over this launch is because it really fits with patients that they're already seeing, and now it's going to give them something new to be able to treat them. And I think that's, you know, that's one of the things that makes being a physician rewarding. I think it fits really nicely with the current practice.
spk05: And then, Ayesha, do you want to talk a little bit about coverage and how psoriasis and cefderm might interact?
spk11: Yes, absolutely. So what we've done to date is we built the groundwork with certain key payer agreements with psoriasis that's actually going to help us to build the foundation for our access with seborrheic dermatitis. I know in the past that we have alluded to having agreements already in place, and so that is what's going to be able to provide us with the access, the foundation that we need in order to secure the access for seborrheic dermatitis.
spk09: Thank you.
spk14: Thank you. One moment for our next call. Our next call comes from Sean Kim of Jones Trading.
spk13: Your line is open.
spk01: Hi, thank you for taking my questions. I guess just one follow-up question on the prescriber base. So of the 13,000 dermatologists that you mentioned earlier in the call, how many are considered high prescribers? And of the 7,500 unique prescribers that you mentioned, How many are also considered high prescribers? And if you're seeing any improvements in terms of the number of prescriptions per prescriber. And one question on pipeline is, as for alopecia areata, just wondering what the timing of top-down readout might be and if there are any efficacy endpoints for that program. Thank you.
spk05: Sure. So, you know, with regard to prescriber base, you know, I think it's a relative term. You know, there are probably around 20,000 clinicians Working in dermatology, that's MDs, DOs, as well as nurse practitioners and physician's assistants. So the 13,000 that we're targeting already are the higher prescribing clinicians. And then, you know, within that, there obviously are gradations as well. You know, there's a relatively small group of the very highest physician prescribers or clinician prescribers, you know, the so-called, you know, decile 8, decile 9, decile 10 doctors. That's a relatively small number. And then, you know, you've got middling doctors and then the lower end of the high prescribing volume, right, if you can think about it. And, you know, I think, as Aisha mentioned, you know, there's no correlation between likeliness to use the newer nonsteroidals and volume. You have some very large volume doctors who aren't using the new nonsteroidals. You have some very low volume doctors or relatively low volume doctors who are. And then, fortunately, you have high-volume doctors who are writing a lot of the newer non-steroids, including Xareeb as well. But, you know, it really, it comes back to just looking at their total volume across the entirety of the prescribing basket, right, the relevant prescription basket. Ayesha, I don't know if you have any additional comments that you wanted to add about the characterization of the prescriber base.
spk10: Nothing else, Frank. I think you've covered it.
spk05: And then, Patrick, can you maybe talk a little bit about the Phase 1 study?
spk17: Yeah, absolutely. So, yeah, this is a Phase 1B trial, so it's not really designed to give us a clear read on efficacy. We're really looking at PK profiles, safety tolerability data, as well as certain biomarkers that we would use to potentially inform our efficacy expectations within the next trial, a Phase 2 trial. You know, we've completed the healthy volunteer portion, and, you know, we're enrolling alopecia areata patients right now, as I mentioned. You know, with regard to the timing of that study, I think as we get further into the enrollment and we have a clearer idea of exactly what that timeline will be, we'll come back to you with a little bit more information on that. But as of right now, given where we are in the study, we're just not ready to say anything more about it.
spk01: Thank you.
spk13: Thank you. One moment for our last question. Next question comes from Rohit Bhasin of Needham. Your line is open.
spk07: Hi, this is Rohit, officer. Thanks for taking our questions. Can you just talk about where you currently stand in terms of managed care coverage and where you expect to be down the line? And then what are your expectations for the upcoming integument PEDE trial? Should we expect different results than previous phase three trials?
spk05: Sure. Ayesha, can you maybe address the managed care question and then Patrick talk about it and take it to Pete?
spk11: Sure. So, first off, as it relates to our managed care coverage, as it relates to commercial, as Ed noted earlier in our remarks, we have 80% of commercial coverage for our patients for plaque psoriasis, for xerae, excuse me. And then of the 80%, 90% of those patients do not have to, there is no prior authorization. Additionally, I will say as outside of the commercial patient population, we did receive notice from the VA that we did receive access for Zareve, and so the clinical guidelines have been updated where there is no step required for patients with Zareve that have plaques in sensitive areas.
spk17: Yeah, and I can pick up on integument P. So just as a reminder, that is a study in two- to five-year-olds. with atopic dermatitis, and it's with the 0.05% dose. The 0.05 and the 0.15% were both studies in the phase two, and the efficacy looked similar between those two doses in that trial. And our expectation for the readout of integument P is that we would see a very similar safety and efficacy profile to what we showed in integument one and two with ages six and above. In general, atopic dermatitis tends to have similar efficacy across the different age ranges when looking at earlier clinical development programs.
spk14: Thank you.
spk13: Thank you. At this time, I would now like to turn the conference back to Frank Watanabe, CEO.
spk05: Okay. Well, first of all, thanks once again to everyone for calling in, and thank you for, as usual, a group of really good questions. I think we're blessed with a wonderful group of analysts that are covering the company. And we look forward to talking to everyone again in about 90 days for the next quarterly call. Thanks a lot.
spk13: Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect.
spk09: Goodbye.
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