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spk09: Good day and welcome to the Arcutis Biotherapeutics third quarter 2023 earnings 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference 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.
spk15: Thank you, Abigail. Good morning, everyone, and thank you for joining this morning to discuss our Q3 2023 financial results. The slides for today are available on the investor section of our website. On the call this morning, we have Frank Watanabe, President and CEO, Todd Edwards, our Chief Commercial Officer, Patrick Burnett, Chief Medical Officer, and John Smith, our Chief Financial Officer. I remind everyone that we will be making forward-looking statements during this call. These statements are subject to certain risks and uncertainties, and our actual results may differ. With that, let me hand the call over to Frank.
spk02: Thanks, Eric. So I'm on slide five of the deck now. So we're really pleased with the Arceus team and our execution in the quarter. We made remarkable progress since the last time we spoke regarding our Q2 earnings. Starting off with the Zareve launch and psoriasis, that continues to gain momentum. And we now have over 110,000 prescriptions and about 9,000 unique prescribers launched to date as our product delivers positive clinical experience for healthcare providers and their patients. This positive tailwind sets us up to launch our future topical reflomalase formulations as well from a position of strength. We also saw significant gross net improvements in the quarter, averaging in the low 70s for the quarter. Once again, we had swallow execution against our clinical and regulatory milestones with a steady flow of successes this past quarter. Patrick will go into a lot more detail in his remarks, but during the quarter we received FDA approval for an expanded psoriasis indication down to the age of six. We filed a supplemental NDA for atopic dermatitis down to the age of six with an expected approval in early Q3 of 2024. We announced positive PISVOTO phase three data for AD in the two to five year old range And we released some really exciting long-term data in AD that demonstrated efficacy continues and actually improves with treatment with Zarif long-term out to 52 weeks, along with a very favorable long-term safety and dependable disease control. We also strengthened our capital position with a follow-on raise we completed in October, as well as the upfront from the out-licensing deal we executed in Huadong for Greater China and Southeast Asia. And John will go into more details in just a minute. John, we'll also talk about some more positive news around positive revisions in our SLR debt agreement that we've recently concluded. And we expect to, we continue to expand our intellectual property estate with the receipt of a new formulation patent in October, which is already listed in the Orange Book, very importantly. And we have a number of additional pending applications that we expect that we'll issue soon, and which will further build on the breadth and depth of our patent protection. Moving on to slide six, we're also very excited about 2024 as we are on the cusp of a very significant expansion of the opportunity for topical reflumelast in the coming year, which will translate into a substantial acceleration in our revenue trajectory. In the next 12 months, roughly, we will expand the total addressable market for Zareve potentially about tenfold. expanding our patient opportunity in the US from roughly 1.3 million commercial psoriasis patients today to over 13 million patients as we add about 1.2 million patients, commercial patients with seborrheic dermatitis and about 1.4 million commercial patients with atopic dermatitis treated by dermatologists following the anticipated approval for those indications. We could also add another 3 million patients across these same indications who have Medicare or Medicaid coverage and who are also treated by a dermatologist. And then finally, we are actively working towards a strategic partnership that could allow us to expand into the roughly 6 million patients treated by primary care or pediatrics across those indications. We know there have been some questions about the pace of conversion from topical steroids to the new or non-steroidals. We talked about this back in Q1 about other similar markets with established generic standards of care and how those conversions to newer class of drugs occurred over time. And the topical dermatology market is right on track with these earlier prior examples with roughly 5% conversion one year in. We remain optimistic that the topical market will continue to convert and will eventually reach roughly 50% conversion. I'm also delighted to have Todd Edwards on board as our new Chief Commercial Officer, and his leadership and proven credentials in the topical dermatology market will only further enhance our commercial execution. Under Todd's leadership, we have a robust plan to further accelerate Xareeb growth and are investing in our commercial operations to drive that growth. With that, let me turn it over to Todd to provide some further commentary around the Xareeb psoriasis launch.
spk12: Thanks, Frank. I'm very enthusiastic about joining Arcuda's team and looking forward to the tremendous opportunity ahead. It is great to be speaking with all of you today to provide a brief commercial update. Moving to slide eight. The Zareve psoriasis launch continues to progress nicely, and we have specific plans to further accelerate the launch trajectory, laying a solid foundation for sustained growth in psoriasis and further growth in new indications. As I come on board, I see healthy, steady Zareve demand that is driven by the strength of the clinical profile. After spending the last several weeks in meetings with dermatologists, MPs, and PAs currently using Xareeb, the feedback I received about the product is exceptional. These prescribers spoke to me about the patients being delighted by the results achieved with Xareeb. The NRX and TRX prescription volume is growing every quarter, and Xareeb has over 100,000 RXs launched to date. We are starting to see a preference for Zareev relative to non-steroidal competitor, and 8 in 10 Zareev riders are increasing their utilization of Zareev. The new pediatric label expansion down to six years of age incrementally expands our opportunity for growth and further strengthens Zareev's safety and tolerability profile. We expect demand growth as we capitalize on our investments in the launch and strengthen our field execution. One very large incremental opportunity to accelerate prescription growth is expansion into Medicaid and Medicare, beginning in early 2024. Roughly a third of psoriasis patients and nearly a half of septderm and atopic dermatitis patients are on Medicare or Medicaid. Xere's pricing falls below the CMS specialty threshold, unlike other branded topicals, so we are much better positioned to access these patient segments. I am now on slide nine. Zareed's differentiated pricing and access strategy continues to resonate with payers, with over 130 million commercial lines covered, 90% without a prior authorization. It was great to see the Arcutis team had secured coverage with all three large PBMs in the U.S. within 12 months of the launch. And most recently, Express Scripts modified the criteria for Zareed coverage, removing the double-step edit for patients who have intertergenous plaques in recognition of Zareef's unique indication for treating these patients. We anticipate further improvements in Zareef commercial coverage as we go into 2024, as well as accelerated commercial coverage for the foam at launch, with two of the top three PBMs expected to cover the product at approval as a line extension. We will continue to build upon the improvement seen in gross-to-net for Q3 and Q4. and expect that progress to continue in subsequent quarters, with us approaching our target gross to net for the psoriasis indication by the second half of 2024. From my experience, I am confident in the opportunity to improve gross to net with DERM products. We are already seeing very encouraging trends in the percentage of prescriptions being covered by insurers, with a clear opportunity to expand on this by enhancing our collaboration with contracted pharmacy partners to ensure willingness to improve coverage rates. I'm now on slide 10. The team has been focused on three pillars of commercial success for sustaining Zuri growth. Firstly, driving healthcare provider awareness and use. The prescriber base is growing steadily, with now about 9,000 unique prescribers since launch. And we just completed a 15% increase in field floor size, focused on high volume geographies. The field team will drive a broad efficacy messaging to move physicians along the adoption curve from initial trial in specific regions of the body to expanded use for patients who have psoriasis plaques across their larger body surface area. Secondly, patient engagement as refills continue to be an important driver of long-term growth. The number of refills in the third quarter increased by 50% versus the second quarter. which continues to be encouraging and in line with what we want and expect to see, given the positive experience patients have with CEREV. As mentioned, we also went live in September with a targeted DTC campaign to drive further branded requests. And finally, the broad high-quality access in both commercial and incremental Medicare and Medicaid coverage creates the opportunity for more patients to experience CEREV. We are also looking forward to upcoming launches and new indications. And so we'll hand it over to Patrick to cover that.
spk04: Thank you, Todd. I'm now on slide 12. As Frank highlighted, it's been a very busy quarter, and I'm extremely proud of the team's performance in delivering on the promise of topical reflux to the dermatology community and hitting all of our timelines with regard to regulatory milestones. So starting with psoriasis first, here we announced the approval down to the age of six This expands our current indication and the overall opportunity in pediatrics, and we look forward to adding two to five-year-olds in psoriasis, which will be the subject of a future FDA review pending some additional data. Moving on to sebderm, which will be the first indication for the foam, where we have an upcoming PDUFA on December 16th, with an early 2024 launch being planned. Physician excitement for sebderm is palpable, driven both by our unprecedented efficacy with this once-a-day foam and an area where there has been no innovation in decades and no branded competition. All this in a market as big as psoriasis. So moving on to slide 13, where I want to highlight a few points on the efficacy in Cebderm. On the left, I'm showing the 80% of patients got the IGA success. This means that they reached clear or almost clear on the IGA scale in eight weeks, and they started from a baseline of moderate or severe. But what's really generated a lot of excitement is on the right where we show that we've got 50% of patients to completely clear. This means they had no erythema, no scaling, no evidence of disease. Not shown on this slide, but also we saw improvement in itch in as little as 48 hours after initiating treatment. Itch is a primary symptom of subderm and really drives an impact on quality of life. So moving on to slide 14 now. Here, patient surveys highlight the significant negative impact that sebderm has on everyday life. Anxiety and a very negative impact on both social and work life with over three in four patients expressing anxiety about their disease. Over 90% say it negatively impacts their social life. In addition, HTPs have expressed to me that they feel like they're failing their patients in many instances because patients keep returning and docs don't have anything to offer beyond the same topical steroids and antifungals that they've been treating them with previously. We also recently reported quality of life data at the AMCP conference, which showed the meaningful benefit rifumelast foam had in improving patient quality of life, as measured by the Dermatology Life Quality Index, or DLQI. Moving on to slide 15. I see Subderm as having some dynamics that are favorable for rapid adoption. We have significant pent-up demand for this novel non-steroidal foam offering, primarily due to lack of branded competition and lack of innovation, but also higher patient dissatisfaction than what we see in psoriasis and a greater need for better treatment options, as many patients are on impractical treatment regimens composed of topical corticosteroids and antifungals that have significant limitations of use. We also have an opportunity to leverage the positive experience in psoriasis with those already prescribing and to leverage foam to further expand the Zareve prescriber base. As Todd mentioned, the benefits of accelerated commercial coverage for the foam at approval also help with HCP confidence in prescribing. Finally, moving on to atopic dermatitis, we made our submission of a supplemental NDA down to the age of six with an anticipated approval in early Q3 2024. It also released a positive PEDE, integument PEDE readout for patients ages two to five in September. On slide 16, we're highlighting Our recent release is some very exciting long-term data in atopic dermatitis that demonstrated efficacy continues to improve with long-term use, meaning four weeks in the pivotal trial and then an additional 52 weeks for a total of 56 weeks. Here we're showing EZ75, which is a very clinically relevant endpoint, where the proportion of respondents grows from about 43% at week four, which is the end of the pivotal, to roughly 66% of patients achieving a 75% improvement at the end of treatment, which is 56 weeks. This is really exciting where patients see an increased benefit over time and disease under better control. But what makes these data even more impactful is that we achieve this disease control with a less frequent maintenance regimen where patients were switched to twice weekly treatment if they were completely clear. Very happy with this response. It fits nicely with clinical practice and it's been very well received by dermatologists. I'm very excited about Flumilast clinical profile and the significant opportunity in this large growing market. The dynamics here are favorable also for rapid adoption, showing some of the same positive tailwinds as seb derm. In particular, in pediatric patients, there's a propensity to adopt non-steroidals, which is higher than in psoriasis, and this is driven largely by the desire of patients to avoid topical steroids. With that, I'll hand it over to John.
spk03: Thank you, Patrick. Good morning, everybody. I'm beginning on slide 18. For the third quarter, we reported net product revenue of $8.1 million, reflecting a 70% growth quarter over quarter on top of the about 70% growth in Q2. This was largely driven by substantial gross to net percentage improvements down to the lower 70s, particularly with the CVS coverage win and the team's execution to ensure prescriptions are covered by insurers. We also saw healthy demand growth in the quarter. Looking forward to Q4, we expect further Zoriv demand growth and gross to net improvement versus Q3. On slide 19, I'll walk you through the rest of the P&L. We reported total revenues of $38 million for the quarter, which included in other revenues the upfront payment we received from Huadong Collaboration and License Agreement, R&D expenses of $26.2 million were down significantly from Q3 2022 due to the upfront milestone payment for the docentis acquisition, as well as continued decrease of development costs of topical rafumilase programs. We expect Q4 R&D to be on par with Q3 and expect fiscal year 2024 R&D expense to decline versus fiscal year 2023. FG&A is a result of higher commercialization expense year over year, which reflects our continued investment in the Zoriv launch and upcoming launches in subderm and atopic dermatitis. As Todd mentioned, additional sales force will drive modest incremental SG&A growth in Q4 versus Q3. Lastly, net loss per share of 73 cents improved by over $1.15 per share year over year. Moving on to slide 20, on the balance sheet, cash and marketable securities of $228 million as of the end of the quarter, which obviously does not include the recent raise of $100 million that we completed in early October. That raise provides a path to expand our psoriasis launch as well as capitalize on the significant expansion in market opportunity for topical rufumilase into seb derm and AD. We also recently undertook a reorganization to resize all non-commercial efforts to align with R&D prioritization. You can expect us to continue to refine and sharpen our efforts around cash burn as we make continued progress on expanding Zareve and all indications. The net proceeds of the capital raised recently in October plus our existing cash plus what we believe to be our forecasted revenue provides a runway into 2025. We also remain confident in progressing an outlicensed deal in Japan, potentially by the end of 2030, to bring in additional non-dilutive capital, which would further extend our runway. I also want to provide some important updates on our amended loan terms, which we recently agreed to with our lender, SLR. As many of you are aware, on the existing $200 million we have on the balance sheet that we've drawn down, there were two, in particular, financial covenants in place, a market cap covenant and a revenue covenant. I'm glad to report that the market cap covenant has been removed and has been replaced with a capital covenant wherein the company has to obtain $31 million by the end of Q1 2024, which could largely come from an upfront payment that I just mentioned around the Japanese outlicense. The revenue covenant has been modified, requiring us to achieve at least 75% of our agreed upon product revenue forecast, which replaces the previous minimum net product revenue table. For year end 2023, this has an effect of reducing the $30 million trailing revenue requirement to below $25 million. Finally, the final loan tranche of $25 million has been eliminated. We appreciate SLR's continued partnership and are delighted with these changes and feel they provide the company significant operating flexibility going forward. With that, I will hand back to Frank, the speaker, and for some closing comments, and then we will open for Q&A.
spk02: Thanks, John. As John mentioned, we continue to evaluate all of our activities as we transition from a development stage to a commercial stage company in order to effectively manage our expenses. Back in Q1, we announced a deprioritization of a number of our R&D programs. And then based on those changes, and as our ongoing large phase three trials are winding down, earlier this quarter, we completed a limited restructuring to better align our organization with their ongoing activities. Today, with the expected approval of reflumilast foam and the successful submission of the AD-SMDA, we're announcing some further changes in our leadership to further align our organization with our priorities. Patricia Turney will be stepping down as our Senior Vice President of Operations, and David Osborne will be retiring as our Chief Technical Officer. Both Patricia and David will continue on as consultants to the company to facilitate this organizational transition and to lend their extensive expertise in the future. We will be merging our technical operations and product development organizations, and Bethany Dudek is being promoted to the role of Chief Technical Officer overseeing the range of these activities. We're excited to have Bethany taking over our technical operations. She's been with Arcutus for the past three years as the head of quality and has done an outstanding job. I would add I've worked with Bethany off and on for the past 15 years. She's an outstanding executive, and I feel very confident about her. She brings to her new position extensive experience across product development, quality, and manufacturing, built over a 28-year career at Arcutus, Kite, Novartis, and Amgen. So with the ongoing Zareeb launch and all of the additional opportunities ahead of us, I believe we are incredibly well positioned to execute on our mission of building the preeminent immunodermatology company and continuing to build shareholder value. And with that, we'll open it up for Q&A.
spk09: Thank you. At this time, we'll conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment for our first question.
spk10: Our first question comes from Tyler VanBuren with TD Cowan.
spk09: Your line is open.
spk08: Hey, guys. Good morning and congratulations on all the progress during the quarter. I have a couple for you related to subderms. So, for the potential topical reflux approval for subderm, can you elaborate on where you are with the regulatory review and if you've started labeling discussions? And then the second question, just regarding the launch trajectory and the coverage relative to Zorii, I think you mentioned that two of the three major PBMs expect to approve it as a line extension. So, does that happen immediately upon approval, or what's the timeframe and logistics? And then also, how long do you think it will take to get the third PBM online?
spk02: Yeah, Todd, great to hear from you. With regard to Cevderm, as a policy, we don't comment on ongoing reviews with the FDA, so I don't feel it would be appropriate for me to make any comments on the process. I will say that I think we feel very confident about the upcoming PDUFA date, and we think that the data speaks for itself. With regard to the coverage, I think I'd ask Todd to respond to that one, if you could, both to clarify around the first two and then our timing on the third.
spk12: Yeah, absolutely, Frank. Thank you. And a good question relative to the contracts and the subterms. As mentioned, with two of the large PBMs within our contracts today, the subterm launch will be treated as a line extension. So what that translates to is that we're starting this launch at a position of strength, meaning that at launch, Those two PBMs will cover Cepterm as a covered product, which will help us also with a good start to our growth to net. The third PBM we are currently in negotiations with, and those negotiations are very positive right now. So we look to further those conversations with the ambition of having coverage at launch with that third PBM.
spk07: Thanks, Abigail. We can go to the next question.
spk10: Thank you. One moment for our next question.
spk09: Our next question comes from Seamus Fernandez with Guggenheim Securities. Your line is open.
spk14: Oh, great. Thanks for the question. So maybe just as a first discussion point, would you guys mind sort of comparing and contrasting the launch of Zareve and where you are in the launch relative to the impact of the, you know, sort of vitiligo launch for the brand that you used to work with. I think it's, you know, sort of an important and interesting comparison, you know, relative to the coverage dynamics as well as the opportunity for warehousing and sort of accelerated growth. So just trying to get a relative sense of where you feel awareness is as a comparison, what this could mean for the overall brand, because unique indications really do seem to accelerate brands overall. And then just maybe if you can provide us a little bit of color on how – you see the, you know, this sort of extension of coverage impacting gross to net, should we be thinking about overall gross to net having a, you know, step down or even a slight movement down in the fourth quarter to kind of accommodate that case. And then just a question for John, you know, it does state, you know, in terms of the covenants, the 75% of, can you just clarify the 75% of revenue target, is that just for this year or is it the sort of sequential targets that are laid out? So 75% of all of the targets that are laid out in that sort of revenue planning phase. Thanks.
spk02: So, Seamus, always good to hear from you. So, just so we're clear, you were asking Todd about Zareve and sort of the dynamics between psoriasis and seb derm and how that compares to Opsalura and the dynamics with atopic dermatitis and vitiligo? Yes. I just didn't name the product. Yep. Yeah, that's okay. I can say that.
spk12: So go ahead, Todd. Yeah, great. No, thank you. So first thing relative to CibDermLaunch, so currently we're working on some disease state awareness activity for both patients and dermatologists. It's a targeted education, which will likely be focused, obviously, pre-launch, with the emphasis on the frustration of the condition, the impact on quality of life, as well as the polypharmacy that occurs here. We're talking about five to six treatments per patient, and often it takes 15 to 30 minutes a day spent with this regimen. So it's a very frustrating situation for patients. There's been no innovation, branded products within this space for over two decades. And if you think about the number of available patients, but you talked about a warehouse of patients, so there is a ready pool of patients that are yearning for a product like Zoriv. that provides a very unique value proposition because this product you can use, you know, once a day product that you can use. It's one product versus Polypharmacy and delivers long-term disease control. If you think about it, there's about 10 million patients that are diagnosed with seborrheic dermatitis. Of that, about 7 million of them are treated with an Rx. If you continue to break it down, about 4 million are treated with an RxNederm setting, and of that, 3.2 million are treated with a TCS. And if you drop it into our treatment zone, 2.2 million of those are moderate to severe patients that are currently taking a TCS. So there's significant opportunity here to really bring Zorib to life. Furthermore, you know, we're starting from a position of strength with this formulary position, as mentioned, where two of the three PBMs will cover as a line extension at launch. And you asked a question about gross to net. So we expect that with the SEDDRN launch, we're not starting from ground zero launching a new asset into the market where you have to provide a free goods program that's going to have an adverse impact on your gross to net. We'll have coverage with the two PBMs. Those will be reimbursed claims and a positive gross to net. So the gross to net will, for Cebderm at launch, will be higher relative to the gross to net that we have in psoriasis. But nonetheless, we believe that that gap will rapidly close over time in 2024 as we bring on that third PBM coverage and maximize our covered claims.
spk03: Hi, Seamus. It's John. To answer your question on the covenants, the 75% applies to the year-end number for 2023, or the year plan number, and then it's a monthly calculation in 2024 with a six-month lagging average. So whatever that number is, you apply 75%. If we're above it, we're good. And that's measured each month in 2024. Great.
spk14: Thank you. And maybe just as just a quick final follow-up, In terms of the stocking necessary to really have this be executed as a robust launch, when should we anticipate the sort of official launch of the foam, you know, regardless of the sort of PDUFA approval timelines? You know, is this a, you know, day of kind of PDUFA hitting the ground running, or should we think about this as, you know, more of a... a potential sort of stocking the pharmacies event in the last few weeks of the year, you know, followed by, you know, maybe a mid-January to, you know, kind of February launch timeframe, just trying to get a little bit of incremental granularity before we get too excited to track the subderm scripts. Thanks.
spk12: Yeah, absolutely. So as mentioned, yeah, the PDUFA December 16th with a full commercial launch anticipated to be mid to late January. So we want to make certain we have ample time to be able to stop the channel, make certain pharmacies have product on shelf as we launch this and drive demand.
spk02: And maybe just to put a fine point on that, you know, Seamus, as you know, with topicals, it's a little challenging because of labeling. It's more challenging than pills or biologics. So I don't think you should anticipate to see any stocking in Q4.
spk07: Perfect. Thanks so much. Yeah, we can go to the next question.
spk10: One moment for our next question. Our next question comes from Vikram Piroit with Morgan Stanley.
spk09: Your line is open.
spk13: Hi, good morning. Thanks for taking our questions. We had two. First, on Zareve and psoriasis specifically, could you just unpack for us in a bit more detail what drove the quarter-to-quarter growth-to-net change we saw from 2Q to 3Q? And then specifically, what needs to happen from here on out to compress growth-to-net from where it is now to kind of steady state? And I think you mentioned second half of next year. And then secondly, on seborrheic dermatitis, apologies if you mentioned this in a response to a previous question and I missed it, but how do you think the actual uptake and script trajectory, excuse me, for sebderm for the initial couple of quarters could compare to what we saw with Zarif for psoriasis post the launch of that product? Thanks.
spk02: Yeah, so I think those probably are both for Todd.
spk12: Yeah, absolutely. So let me first cover off on relative to the gross net and what drove the change in gross net, what we need to continue to do to amplify improvement. So the improvement in cover access we saw in Q2, obviously accelerated in Q3. So we saw an improvement in the percentage of cover prescriptions across all the major PBMs in Q3 with CVS driving the most dramatic improvement. Also see an improvement across the other two large PBMs. You think about it, this translates into reduced co-pay expenses and provides us a springboard to continue to improve gross to net and leverage this progress further. We expect our field force execution and to be a continued focus on pulling through our coverage to produce improved gross to net in Q4 and beyond. And as we roll forward, we're going to be building and working, developing partnerships with dermatology pharmacies, which reinforces our conviction that we can achieve our target gross to net. So through approved coverage, through our partnerships with these independent derm pharmacies will translate into further improvements as we go forward with our gross to net. And then the other question was? Subderm uptake relative to psoriasis. Yeah, subderm uptake relative to psoriasis. As mentioned, there's a ready pool of patients that are journeying for new treatment options with subderm. There's no branded competition within the market, no innovation in the market for over two decades. And so I would anticipate a robust uptake. at launch with Cevderm, whereas compared to the psoriasis market, you know, it's a highly competitive market, multiple competing products within there, which Cevderm is very much unlike that.
spk02: And, Vikram, I just remind you, you know, to Todd's point, we picked up that CVS coverage 7.1, so right at the beginning of Q3, so that was certainly a major contributor but not the only contributor to the improvements in gross to net.
spk07: Understood. Thank you.
spk10: One moment for our next question. Our next question comes from Oi Ear with Mizzou.
spk09: Your line is open.
spk01: Hey guys, congrats on the good quarter and all the progress. I guess my question is for Todd. You know, you've been there for a little while now and just wondering what are some of the changes that are different that you're looking into executing? I know that you've already added some Salesforce, increased the Salesforce size, but what are some other changes that you might put in play to improve script uptakes for psoriasis and maybe, you know, as well as for the CEP DERM upcoming launch? Thanks.
spk12: Yeah, absolutely. And just a few things. You know, after many years in dermatology, I see a tremendous opportunity to change the treatment paradigm in these three largest disease areas that we've been talking about here today to include psoriasis, eventually septum and atopic dermatitis. If you think about it, the dermatology community, they've been yearning for non-steroidal options that still fit with their, what I'll call their topical first mentality. are oriented towards their local treatment. You think about a series data package, especially the long-term data, PSO, or CEPDRM or AD, and it's exceptional in my view, and it really hits the outcomes that dermatologists and patients are looking for. So I see a ready opportunity advancing the competitive share of voice, our messaging, which of course are known levers that can drive utilization within the dermatology community. In addition to that, if you look at the perceptions of efficacy, they're very encouraging, and the differentiating attributes of Xareve are resonating with prescribers. And as mentioned, the long-term data, I think, is extremely meaningful and really differentiates that long-term value of Xareve. But dermatologists, they're well-ingrained. They're creatures of habits, and it takes time to get them to critical mass... of patients that affirms Zuri's place within the treatment paradigm. And by creating depth within our current prescriber base, moving them along the adoption curve, and moving up the average number of Zuri patients per prescriber will continue to accelerate the uptake in Zuri. And as mentioned, we've hired the representatives to amplify our share of voice. In September, we launched a targeted direct-to-consumer campaign, which we will continue to move forward And we're going to have an expansion on the efficacy message to dermatologists to include a broader target patient with a higher BSA. And then I think as mentioned earlier, there's an exceptional opportunity for expansion within Medicare and Medicaid, and that's also to mention that expanded pediatric indication down to the age of six will provide us with another expansion opportunity in psoriasis.
spk02: Maybe I'll just add, because Todd is modest. You know, we ran a very extensive search for our new chief commercial officer, and it was very clear to me that Todd was the right person to join this team. I believe that leadership matters, and we chose Todd because, you know, look, he has a proven track record. He's done this before. He's successfully launched other topical products in the space very recently, has very effectively driven demand, and has also very effectively managed gross to nets. And I have complete confidence in him and his ability to lead our commercial team. We also did announce the promotion of Aisha Jeter to head both marketing and market access. She had been previously, well, she was the interim chief commercial officer and had been running market access. And I think along with Todd, I have real confidence in their ability to launch these additional indications and continue to drive the growth of xereve and psoriasis.
spk01: Can I follow up with just a question on gross to net? So I guess if your target is to reach steady state somewhere sometime in the second half of next year, it sort of implies that the you know, the quarterly pace improvement is pretty significant. I was just wondering if you can sort of just talk a bit, perhaps, you know, help us quantify what the improvement could be in the fourth quarter, at least. Thanks.
spk06: You know, I'm thinking about it.
spk02: We tend not to give forward guidance on growth sets. I would say, you know, we saw a very significant improvement in Q3 over Q2. We saw a nice improvement Q2 over Q1. I think we will see further improvement in Q4 versus Q3. I won't commit that it will be of a similar magnitude as what we saw in Q3 because that was a pretty big move. But I think Q4, you may see a little bit of noise in Q1 with the copay recess, but we'll continue to make progress there in Q2 next year as well. I think it's not a miracle occurs here sort of phenomenon for us to get to our target gross to net situation. with continued execution against the programs we already have in place and the coverage we have in place.
spk01: Okay. Thank you.
spk10: One moment for our next question. Our next question comes from Chris Shibutani with Goldman Sachs.
spk09: Your line is open.
spk05: Thank you very much. On the commercialization effort, the increase in the sales footprint that you have, can you give us a sense for how maybe more specifically the composition of this group might be able to be impactful, and what's the appropriate way to think about the timing for a potential inflection from that? And then, Frank, I think historically you've acknowledged how AD as a market is certainly quite vast, and to market to a primary care type potential market, it would contemplate a partnership for that market specifically. Can you talk about what your latest thinking is there? Thank you.
spk02: Yeah, sure. Maybe I'll take the second question first, and then I'll ask Todd to talk about the sales force. Yes, Shiv, you are absolutely correct. You recall correctly our previous comments. About half of the atopic dermatitis market and also about half of the seborrheic dermatitis market exists out of dermatology. A lesser portion of the psoriasis market, there's not insignificant number of psoriasis patients also treated outside of dermatology. The challenge for the primary care and pediatrics markets, which is where most of those patients sit, is just the breadth of the prescriber base. You're talking 250,000 prescribers versus 13,000 prescribers. It's not economically viable for a company like ours to build a primary care sales force. And so we have been saying all along our intention was to find a partner that had an existing primary care sales force that could do a co-promote for us in those markets. That continues to be our plan. And I would just say at this point that we're in active discussions with potential partners to try and strike an agreement. We also have said in the past that You know, from a timing standpoint, ideally we want to have that partnership in place sometime around the atopic dermatitis approval. And I say around because, you know, the PCPs are going to be looking to the dermatologist for guidance. And so we have to win with the dermatologist first. I don't think we need to have that PCP partnership in place at launch, but you would want to have it sometime shortly after that launch or there wouldn't be any downside to having it before either. So I think you should really be thinking about us hoping to have that in place in the second half of 2022, 2024, excuse me. And then, Todd, do you want to talk a little bit about the Salesforce expansion?
spk12: Yeah, relative to the Salesforce expansion, the 15% increase in share of voice. So that 15%, we took that 15% and we overlaid the current Salesforce. What we did is look at the high prescribing geographies to make certain that we can continue to obtain the desired frequency and reach and engagement with those high prescribing physicians. So we overlaid that 15% into those geographies. In addition to that, as we move through 2024 and the atopic dermatitis launch, we'll at that time give consideration to potentially another expansion to make certain that we have the share of voice required to be able to engage across the three indications. And don't forget the 2023 RQDIS aligned a group called the Pharmacy Access Managers within the field. This team engages directly with the independent pharmacies as well as the staff within the dermatology offices to ensure that we're getting appropriate prescription fulfillment. So I feel that the organization's at a very good place right now to have the appropriate shared voice that we need to be able to continue the acceleration of xeribs or psoriasis and make certain that we start from a position of strength and a quick start to the septum launch.
spk02: And that expansion we completed October 1. So, you know, I mean, I think we'll see some impact even in the fourth quarter and, you know, that will continue on into 24. Yes, absolutely.
spk05: Great, thank you. Look forward to the momentum from that new sales force.
spk10: One moment for our next question. Our next question comes from Sean Kim with Jones Trading.
spk09: Your line is open.
spk11: Hi, congratulations on the quarter, and thank you for taking my questions. I guess just a few quick questions on my end. So first question is, As you look to move into government, Medicare, Medicaid, patient populations, can you comment on the potential additional operational efforts and maybe financial burden that will be required to tap into that market and maybe potential sales opportunities there? And my second question is about the Salesforce extension as you look to launch Cepterm and also atopic dermatitis. I believe you mentioned about 9,000 unique prescribers that have prescribed Zorif so far. So I just wanted to hear your thoughts on the efficiency of Salesforce. It looks like a little over 10 prescriptions per prescriber. So I'm just wondering if there's opportunities to expand the number of prescriptions per prescriber and also the potential expansion to reach that 13,000 target that you mentioned last time around. My last question is about the SLR loan agreement, the modifications to the financial covenants. I just want to make sure that I understand correctly that the original threshold, the minimum threshold, remains for year 2025 and 2026. Thank you.
spk02: Great. Maybe let me take your second question and then I'll have Todd addressed your first question and John addressed your third question. So, yeah, look, I think with regard to our breadth and depth, we've talked about this before. There are about 13,000 targets that we are targeting with our sales force. They represent over 90% of the relevant prescriptions in dermatology. Out of that 13,000, about 9,000 are currently writing. So, you know, there clearly is an opportunity to expand the breadth of our prescribing base. You know, I don't think we will ever get all 13,000 of them because, you know, you have some doctors who just, you know, are... ultra conservative and are never going to change from using their old topical steroids. But I think we'll eventually get very high penetration. And we've been adding roughly about 500 doctors a month for quite some time now to that prescribing base. I think we were sitting at 7,000, I think, in the last quarter, something like that. So we will continue to expand the prescribing base. I'm confident of that. And I think, as Todd mentioned, I think the foam could actually help us with that broadening of the prescriber base. And then I think you also are correct that there is an opportunity for a lot of deepening of the prescribing base. You know, if you look at the topical steroid market today compared to the topical non-steroidal market, you know, the topical steroid market is about 20 times the size of the non-steroidal market, right? So even doctors who are writing, you know, 10 Zarev scripts, you know, are probably writing 20 times that in topical steroids. And so there's immense opportunity for us to continue to expand that market. And that really gets back to my earlier comment about the conversion. We're in early stages of the conversion process, but we're exactly where we'd expect we would be in terms of conversion. And if you look at any number of other markets, you can get a pretty good sense of how that's going to progress in the coming quarters and coming years. And we feel very confident that conversion will happen as it's happened in other markets. just because the new non-steroidals offer doctors and patients so many benefits. Todd, do you want to maybe talk about what sort of the lift looks like for us getting into Medicare and Medicaid both financially and operationally?
spk12: Yeah, well, Medicare and Medicaid, as I mentioned in the opening remarks, there's approximately 3 million patients that are employed here. And if you think about Cepterm, it's more so on the Medicare side and atopic dermatitis on the Medicaid side. We've been actively engaging in the Medicaid space to be able to secure coverage for patients in 2024 in preparation for the atopic dermatitis launch. In addition to that, we're having conversations with the big three PBMs relative to the Part D plans in Medicare with the ambition to secure that coverage in the first half of 2024. I think what's very important to note here, especially with the Medicare, is that the RQ, this is a repricing strategy. Given where our price point is, and it's below the CMS specialty tier, we will very likely be able to gain this coverage in Medicare with a nominal impact on our gross to net. So we're actively engaged, and those conversations are progressing.
spk03: Let me take the – yeah, and then if you want to – on the SLR covenant, the way it works is, you know, if you were to look at it today, there is a table with specific revenue targets that – prior to the amendment, we were held to with respect to the loan agreement. That's been replaced with an agreement around a plan, which we do every year as due course. And there's agreement and approval of that plan by our board and SLR. And whatever that plan is, you apply this 75%. And if we're above the 75%, we've met the covenant is how it mechanically works.
spk10: Thank you.
spk09: That concludes the question and answer session. At this time, I would like to turn the call back to Frank Watanabe for closing remarks.
spk02: Okay. Well, I appreciate everyone making the time to call into our earnings call this quarter, and we look forward to talking to you all in another quarter with an update on further progress at Arcutis. Thanks again.
spk09: Thank you for your participation in today's conference. This does conclude the program. Goodbye.
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