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spk13: Good day and welcome to the Arcudis Biotherapeutics 2023 fourth quarter and full year financial results conference call. At this time, all participants are in listen only mode. After the speaker 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 has been raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the call over to Derek Cole, Arcudis Investor Relations. Please go ahead.
spk08: Thank you, Andrew. Good morning, everyone. And thank you for joining us today to review 2023 financial results and a business update. Slides for today's call are available on the Investor section of the Arcudis website. On the call today, we have Frank Watanabe, president and CEO, Patrick Burnett, chief medical officer, Todd Edwards, chief commercial officer, and John Smither, chief financial officer. I'd 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. We encourage you to review all the company's filings with the Securities and Exchange Commission, including descriptions of our business and risk factors. With that, let me hand the call over to Frank.
spk11: Thanks, Derek. I'm now on slide five of the deck. We've had a lot of really exciting progress since we last spoke for our Q3 earnings call, and I couldn't be more pleased with the Arcudis team and our execution in the quarter, nor more excited about the foundation these results lay down for progress in 2024. We continue to see growing momentum in the Zareev cream launch and psoriasis as health care providers and their patients see how it addresses real needs in their treatment of psoriasis. We've now generated over 165,000 prescriptions and over 10,700 unique prescribers to launch to date as our product delivers positive clinical experience for HCPs and their patients. We continue to make significant progress on our growth to net each quarter with improvement in Q4 over Q3 of a similar magnitude as seeing Q3 over Q2 taking us to an average in the mid-60s for the fourth quarter. The solid growth and prescriptions coupled with continued growth to net improvements drove strong revenue growth in Q4, both versus Q3 and year over year with fourth quarter net revenue of $13.5 million. Coming on top of our progress with Zareev cream and psoriasis, we also received approval for Zareev foam for seborrheic dermatitis in December and launched in late January. I don't think I've ever seen comparable levels of excitement amongst patients and dermatologists as what we're hearing about Zareev foam. We also continue to execute against our clinical and regulatory milestones with a steady flow of successes this past quarter. Patrick will go into a little more details in a minute, but during the quarter, the FDA accepted our supplemental NDA for atopic dermatitis down to the age of six and assigned a target date of July 7th, 2024, potentially expanding our portfolio even further. We also released very exciting interim long-term data from our open label study in AD that demonstrated efficacy continues to improve with long-term use out to 52 weeks, along with favorable long-term safety and dependable disease control. We've seen robust, consistent and predictable efficacy across all targeted indications, including psoriasis, sebederm and atopic dermatitis in each of their respective pivotal trials. In addition, in October, 2023, the US Patent and Trademark Office awarded a new formulation patent that covers a means for inhibiting reformylase crystal growth that is not limited in hexylene glycol. And in November, 2023, the company was also awarded a new method of treatment patent covering a topical reformylase formulation with an extended half-life. Both patents do not expire until 2037. And then October, we completed a secondary offering that raised $102 million, putting us in a strong financial position to continue investing in the ongoing launches in Plaxoris and SebDerm, as well as the potential atopic dermatitis launch later this year, while continuing to development, the development of our pipeline. Moving on to slide six, a major reason why we're so excited for this year is that we are in the midst of a very significant expansion of the opportunity for topical reformylase, which we expect will translate into a substantial acceleration of our revenue trajectory. You've seen this before, but from the initial approval for psoriasis, the total addressable market for Zureve could grow around 10-fold this year alone to over 15 million patients in the United States. We have the right commercial team in place for success, and we have an excellent plan to execute against these opportunities. With that, let me turn it over to Todd to provide some further commentary around the Zureve cream launch and psoriasis and update you on how the foam is progressing in SebDerm.
spk03: Thank you, Frank, and I'm very enthusiastic about our growing commercial portfolio, recent progress, and the tremendous opportunity I see ahead. Moving to slide eight, the Zureve psoriasis launch is accelerating, and our execution strategies are showing signals that we are able to push the launch trajectory in psoriasis. These efforts also lay a solid foundation for sustained growth in SebDerm and potential further growth in new indications upon approval. The NRx and TRX prescription volume is growing every quarter, and Zureve has over 165,000 TRXs launched to date. Fourth quarter, 2023, TRXs were up 26% compared to Q3 2023, and over 290% compared to the fourth quarter of 2022. We're starting to see a preference for Zureve relative to the non-steroidal competitor as evidenced by our steady gains in market share, and eight in 10 Zureve riders are increasing their utilization of Zureve. The new pediatric label expansion down to six years of age incrementally expands our opportunity for growth and further strengthens Zureve's safety and tolerability profile. Refills continue to be an important driver of long-term growth. The number of refills in the fourth quarter increased by around 39% versus the third quarter, and now constitute more than one in three prescriptions, which is in line with what we want and expect to see given the positive experience patients have with Zureve. I am now on slide nine. There are multiple important dermatology conferences in January. After spending time with dermatologists, MPs, and PAs, currently using Zureve Cream, the feedback I receive about the product is exceptional. These prescribers spoke to me about their patients being delighted by the results achieved with Zureve. The prescriber feedback is clear that there are some distinct attributes of Zureve Cream that make it attractive. The ability to be used anywhere, once daily dosing, compelling efficacy data, favorable tolerability profile, safety and appropriateness for any psoriasis patient, and these attributes make Zureve Cream an attractive treatment for patients with different types of needs. The patient who is concerned about steroids, the patient who has been cycling through various topicals, or ones that are exploring different treatments to find that works for them long-term or to manage flares. We know that psoriasis patients have differing needs, depending on where they are in their journey, and see that Zureve Cream can really be a solution for most of these patients. I'm now on slide 10. The team has been focused on three pillars of commercial success for sustaining Zureve Cream growth in psoriasis. Firstly, driving ACP awareness and use. The prescriber base is growing steadily, with now over 10,700 unique prescribers since launch. Our experienced field sales team is focused on high volume geographies. The field team continues to deliver broad efficacy messaging to move physicians along the adoption curve from initial trial and specific regions of the body to expanded use for patients who have psoriasis plaques across a large body surface area. Secondly, patient engagement and positive use experience. Refill volume has increased to 38% of total volume, and Zureve patient awareness continues to improve. And finally, the broad high quality access in commercial and anticipated Medicare, Medicaid coverage creates the opportunity for more patients to experience Zureve. Zureve's differentiated pricing and access strategy continues to resonate with payers. With over 132 million commercial lives having access to Zureve Cream. The Arcutus team successfully secured coverage for Zureve Cream with all three large PBMs in the US within 12 months of the launch. And we anticipate further improvements in Zureve commercial coverage throughout 2024. And PAs and step edits are typical for branded products and dermatology. And for Zureve, this process is now well understood by pharmacies and dermatology offices. We are seeing very encouraging trends in percentage of cream prescriptions being covered by insurers. With a clear opportunity to expand on this by working with contracted pharmacy partners. From my experience, I am confident in our ability to continue to improve our growths to net. We saw very good improvements in growths to net during Q4, and expect that progress to continue in subsequent quarters. With us approaching our target growths to net in the 50s for the psoriasis indication by the second half of 2024. One very large incremental opportunity to accelerate prescription growth is the expansion into Medicaid and Medicare, which we expect to begin as early as 2024. Roughly a third of psoriasis patients and nearly half of septum and atopic dermatitis patients are on Medicare or Medicaid. So this is a very important opportunity for us. Zureve's pricing falls below the CMS specialty threshold tier unlike other branded topicals. So we are well positioned to access these segments. Now moving on to slide 11. We are seeing a tremendous early response to the launch of Zureve Foam, the first drug approved for septum dermatitis with a new mechanism of action in over two decades. As you have likely seen in ITUVIA data, we have a strong start to the launch with a very positive launch trajectory. The first approved treatment, unconstrained by severity, duration and location. Zureve Foam is different than anything else that the DERMS or patients have seen for this disease. With treatment success in eight in 10 patients in our pivotal trial, with over half of these patients completely clear in just eight weeks. Significant impact on itch, most bothersome symptom of this disease with improvements seen as early as 48 hours. Simple, once daily leave in application that's much more convenient than any other option. And taken together, we believe Zureve Foam can be the new standard of care in managing sederm. I'm now on slide 12. With a product profile offering rapid dramatic disease clearance and significant reduction in itch, with a simple single treatment, HCPs and patients are very enthusiastic about the availability of Zureve Foam. 81% of survey prescribers view this Zureve Foam profile as very compelling or compelling. They also recognize the attributes of applicability to any part of the body. The uniqueness of the vehicle and critical efficacy needs for this patient type of rapid response in itch and erythema. Which then helps to reduce the number of treatments in the regimen and potentially leads to improved compliance. On slide 13, as mentioned previously, we have secured access with the three national PBMs who recognize Zureve Foam as a line extension under the Zureve cream contracts. This has translated into an increased volume of covered prescriptions early in the launch period, with covered prescripts already near 50% of total volume. We continue to work with the downstream health plans to put them on board and this accelerated coverage will translate into a more rapid improvement in growth to net compared to what we saw with the cream launch, with the new germ products. Finally, all the key EMRs already have Zureve Foam available for electronic prescribing. Moving to slide 14, building on the strength label and product profile, we are confident that we have the ingredients in place for successful launch of Zureve Foam in CEDDerm. With relationships already built with dermatologists, a field team trained on the value proposition and ready to promote and educate, contracted pharmacies in place, familiarity with the copay card and processes that go with the product, and access with PBMs to ensure patients get the drug. I look forward to updating you further on our commercial progress throughout the year. We're also looking forward to upcoming launches and new indications. And so I will hand it over to Patrick to cover that.
spk09: Thanks, Todd. I'm extremely proud of the team's performance in delivering on the promise of topical flumeless in the dermatology community and hitting all our timelines with regard to our regulatory milestones. On slide 16, I'm gonna cover these according to indication with psoriasis first. Here we have approval down to the age of six after we've expanded the indication and the opportunity in pediatrics to reach the two to five year olds will be the subject of a future FDA review. Next for CEDDerm, with our approval in December and the recent launch, physician excitement is palpable and the feedback at medical congresses has been very positive. The profile here is unprecedented efficacy with a once a day foam in a market as big as psoriasis with no innovation in decades and no branded competition. So moving on to atopic dermatitis, as Frank mentioned, the FDA accepted our supplemental NDA for raffumelase cream as a potential treatment for atopic dermatitis for patients down to the age of six and they assigned a PDUFA action date of July 7th of this year. And finally, we're also expecting to submit another SNDA with the FDA for zerif foam in scalp and body psoriasis in the second half of 2024. On slide 17, I wanna highlight some recently released pooled data from our phase three AD studies in tegum at one and two. And it's quite notable and highly unusual that over 90% of patients saw improvement in their symptoms in just four weeks and nearly 70% seeing at least a 50% improvement. Looking at the more demanding easy 75 hurdle, almost 45% of patients achieved this large improvement at week four. And encouragingly, in the long-term study which we've released but aren't showing here, at the end of 56 weeks, two out of three patients had achieved a 75% improvement. It's really exciting to see where we have a high proportion of patients responding early and then seeing an increased benefit over time with long-term treatment. And in that long-term study, we also looked for the first time at our ability to control the disease with a less frequent maintenance regimen where patients were switched to twice weekly treatment if they reached complete clearance. We're really happy about the response there. This regimen fits nicely with the current clinical practice and these data have really resonated with dermatologists. We're excited about the -Las-Cream clinical profile for AD and the significant opportunity in this large and growing market. Dynamics here at AD are favorable towards rapid adoption and share some of the positive tailwinds as sub-derm. In pediatric patients especially, here in AD there's a propensity to adopt non-steroidals higher than in the psoriasis patient population and that's largely driven by parents' avoidance of steroids. So moving on to slide 18, I wanna highlight the itch response across our portfolio of products. So here we're showing WINRS, or Worst Itch Numeric Grading Scale results of our phase three studies. These are pooled results for psoriasis dermis and the AD entegument studies and these are individual study results for stratum and erector. Itch is a primary symptom for these conditions and a key driver of our quality of life impact. So there's rave cream and foam at .3% and topical or flumulast .15% cream for AD provided consistent and rapid improvements in itch across psoriasis, sub-derm and AD respectively with improvements as early as 24 to 48 hours as compared with vehicle treated patients. This includes scalp psoriasis in the erector study which is particularly difficult to control and only four weeks of treatment in the entegument studies. Across indications, we have a significant proportion of patients achieving an itch-free state. And with that, I'll pass it over to John.
spk14: Ladies and gentlemen, please stand by. Ladies and gentlemen, please stand by.
spk15: Operator, can you hear me? This is Frank. Yes, I can hear you
spk11: now. While we're working on John, I'll take over for him for just a minute. So if you're listening, so I'm on slide 20. So we achieved 29.2 million in net product revenue for Zuri for the full year 2023 with 13.5 million of that in Q4 reflecting a 67% growth from Q3 to Q4 which comes on top of the approximately 70% sequential growth we saw from Q2 to Q3. This was driven by substantial growth, growth in net, excuse me, percentage improvement down to the mid-60s and the team's success in pulling through covered prescriptions. We also saw healthy prescription growth in the quarter. So looking forward to 2024, we expect continued prescription growth and growth in net improvements for Zuri, criminal psoriasis and continued prescription momentum and GTN improvements for Zuri foam. Although there will likely be a temporary erosion in psoriasis growth in net improvements in Q1-24 versus Q4-23 due to the typical deductible resets and patients changing their coverage that always occurs at the beginning of the year. Turning to slide 21, you can see the strong performance in the fourth quarter with net product revenues for the quarter of 13.5 million up over 10 million from Q4 of 22. Our in the expenses for the fourth quarter were 23.8 million which is down significantly from Q4-22 due to continued decrease of development costs on topical reform last programs. And recall that our R&D expense includes research, operations and medical affairs spend. On slide 22, looking at full year, full year total revenues of 60 million with 29.2 million in net product revenues and 30 million in other revenues related to the upfront payment in connection with the Hwa-Dong collaboration and licensing agreement we received in Q3. R&D expenses for full year were 111 million which is down 70 million approximately due to the one time $30 million fee associated with the due census acquisition in 2022, winding down of our major reform last phase three studies and lower pre-commercial production. We expect full year 2024 R&D expense to decline meaningfully versus full year 23 as we continue completing the few remaining phase three studies, continue with regulatory filings, reduce our pre-launch production costs and maintain our medical affairs activities to support the launches. SG&A expenses for the year were 185 million primarily due to higher commercialization expenses year over year driven by continuing investments in Zareef cream and preparing for the ongoing launch of Zareef foam and the potential upcoming launch in atopic dermatitis if approved. As we head into 2024, we expect SG&A to increase over 2023 which aligns with the investment behind our syndrome launch and preparations for the atopic dermatitis launch including our previously announced incremental expansion in Salesforce. We will continue to focus on appropriate investments to support our commercial activities. Launching drugs properly requires substantial investments in staff and promotional investment and having multiple launches in a short period of time really magnifies these resource demands. It's important to note that we have made concerted efforts to adjust our operating expenses to reflect our transition from being exclusively a pre-commercial company to a commercial enterprise and ensuring we invest appropriately in current launches and if approved, ensuring the same for our future launches. We don't wanna be in a position of under investing and harming the trajectory for the ongoing launches in psoriasis and sebederm or future launches if approved. Earlier in the year, we undertook a reorganization and reprioritization of non-commercial efforts to align with our commercial execution focus in 2024, which will result in aggregate approximately 50 million of reduced expenses over the next two years as compared to previous internal forecasts. You can expect us to continue to focus on cash burn as we look for opportunities to maximize our OPEX while making continued progress on maximizing the Zareve opportunity across multiple unique indications. A top priority for our team is being good stewards of the investor capital entrusted to us and we believe we have demonstrated an excellent track record thus far. We have made appropriate levels of investment that established our pipeline, achieved nine positive phase three clinical trials and now two FDA approvals with a third potentially coming mid-year while launching two products to date and if approved, another in the second half of 2024 and a fourth in 2025. On slide 23, our final slide on the balance sheet, we had cash and marketable securities of 272.8 million as of December 31st. As I mentioned a previous slide, our current capital enables us to continue to invest appropriately in commercial initiatives. We also remain confident about concluding an out-licensing deal in Japan to bring in additional non-dilutive capital, which would further extend runway and largely address the capital requirement covenant with SLR. Additionally, we are actively pursuing a primary care partnership and are seeking and seeing early interest from our efforts there. So that's it for our comments today. If I step back for a minute, we founded Arcudis with a vision of bringing meaningful innovation to the medical dermatology space, especially the topical space. With our second launch in less than 18 months, I'm proud that our team is making that vision a reality and in the process is helping a growing number of people suffering from dermatologic conditions. As we continue to execute on the psoriasis and sebederm launches and hopefully adding the atopic dermatitis launch later this year, we look forward to helping millions of people allowing us to create additional shareholder value. We are confident that 2024 will be a transformational year for Arcudis. And with that, we will open it up for Q&A.
spk13: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, press star one one again. One moment, please. And our first question comes from Brian, I think we're
spk05: back on.
spk13: Tyler, thanks. With TD Cowan, your line is now open.
spk23: All right, I think that's me. Good morning, guys. Thanks for taking the question. So the subderm prescriptions for Zareve foam have gone vertical very early in the launch and have reached levels that Zareve, Creme, and Vatama took significant longer to reach. So I understand that having coverage from day one is a huge benefit and there's not a direct competitor, but what else would you attribute the success to early on? And do you think Zareve foam could ultimately end up being significantly larger than the Creme?
spk10: Yeah,
spk11: I think maybe Todd, if you could take that and then Patrick, see if you have any additional comments after Todd's comment from a commercial standpoint.
spk03: Yeah, thank you, Frank. And yeah, as mentioned, we're very pleased with the uptake of Zareve foam. And I mean, with the weekly demand trends, I'd say it's too early to comment on how much of that is coming from a warehouse of patients, but I would say that one big driver of this initial uptake is just that, that it's a ready pool of patients that are out there. And these patients have been waiting for Zareve foam. They've been waiting for a more convenient, more effective treatment. And so I think that that's been driving this, but we expect continued strong growth to the product, but I just caution that a linear progression based on the rate trend is probably overly optimistic, but I think that there's a long runway for Zareve foam and we're looking forward to continuing to grow this product.
spk00: Patrick,
spk09: any additional
spk03: medical thoughts?
spk10: Yeah, go ahead. Yeah,
spk09: I think just kind of adding the perspective of how this might fit into practice for dermatologists. Severe dermatitis patients can be a challenging patient type in the dermatology practice, just because you've had them in your practice for 10, 15 years sometimes. We know that there's a very long runway for patients. Before they actually get to a diagnosis. And oftentimes they've tried everything that's out there. And in this space where we haven't really had any innovation for 10, 20 years, remember this is the first new mechanism of action for a prescription topical in over two decades. Yeah, I think there really is a lot of interest in having a new therapy. And that translates into a level of frustration for the dermatologist that was kind of pent up prior to this, because when a patient would come back in, they just had nothing to offer them that wasn't a topical antifungal or a topical corticosteroid. So I think that this is simply a component of solving an unmet need where there are patients who are dissatisfied with the treatment and healthcare providers who haven't really had anything new to offer. And we've heard that in anticipation of the approval in launch for the two or three years while we were running our phase three studies, looking for the FDA to approve the drug and we think that there was a high level of anticipation for this
spk06: for those reasons.
spk13: Thank you. One moment please for our next question. And our next question comes from the line of Oye Ear with Mizuho.
spk18: Hey guys, yeah, thanks for taking my question. So just on the launch, the septum launch, could you, you speak of warehousing effect. Are you sort of suggesting primarily that these are kind of patients who have limited options and I guess are you seeing, what kind of patients are you seeing generally? Are they, do they tend to be more on the severe side or the mild side and could you sort of just maybe provide some of the demographics a little bit if you have such data? Yeah, so that's my first question. I'll follow up with a second question, thanks.
spk11: I think that the point we're trying to make is, think about it, it's been over 20 years since there was a truly new drug for seborrheic dermatitis and so there is a very large pool of patients as Patrick, or Todd mentioned, excuse me, who have been eagerly awaiting Zuree Foam's availability and I think some of the very early demand is probably these patients who have been, as Patrick mentioned, have been cycling for three years and have been just sitting in the office and now all of a sudden the doctor has a new option and they're gonna put them on Zuree Foam. So we think that there is this pool of ready-made patients that is helping the early launch but we wanna make sure that folks don't think that that pool will exist forever with this constant stream of very large patients. Having said that, our research suggests that dermatologists see about 75 sebederm patients a month so it's a very large population of patients which should sustain long-term growth for us. In terms of your question around the demographics, I think it's really too early for us to have any data on that. We'll be looking at adoption and where doctors are using it as we get farther into the launch and we'll be able to share some of those data in the future but at this point in the game we don't have any data on that yet.
spk18: Okay, and maybe even it may help us understand a little bit. So during the earlier call, the launch call, you indicated there were a script some that were waiting at the pharmacies. Are you still seeing significant number of scripts that have not been filled or shipped to consumers or at this point these scripts, they come in and they are, I guess, readily shipped. Just wondering if there's a large delta. And maybe along that line, could you kind of also help us understand in your Zareve direct program, is there any differences between the cream and the foam and in terms of getting it processed and if there's any, yeah, just wanting a little more clarity on that, thanks. Sure, yeah, sure. Todd, can you take those two?
spk03: Yeah, absolutely. As mentioned, prior to the commercial launch, there was a number of prescriptions that were sitting at the pharmacy but those prescriptions have all been filled and distributed to the patient. So we don't see what I'll call a warehouse of prescriptions sitting currently at the pharmacy today. And then relative to our Zareve direct program, I think this is a big strategic advantage for us, is that the program's identical. It's the same program for Zareve cream and psoriasis or for Zareve foam and seborrheic dermatitis. And that creates a great efficiency for the dermatology offices, given that two unique products for two distinct patient populations, psoriasis and sebderm, but one process in fulfilling that prescription. And so that is a common process across both products.
spk17: Okay, thank you.
spk13: Thank you. One moment please for our next question. And our next question comes from the line of Chris Shibutani with Goldman Sachs.
spk24: Hi, thanks for taking our question. This is Steven on for Chris. One on the subderm launch, curious if we should expect any inventory or channel stocking effects in the first quarter. And then as far as the commercial team goes, do you believe the team is currently right size for the psoriasis and sebderm opportunities? And if we should anticipate any changes ahead of atopic derm? Thank you.
spk10: John, do you wanna maybe take the channel question and then Todd, could you address the team?
spk15: With respect to Q1, no, we're not anticipating
spk07: any channel buildup with respect to Q1.
spk03: Yeah, and then a question relative to being right sized, especially for the potential atopic dermatitis launch. In anticipation of that launch, we will expand our field of cells organization. Today, roughly we have around 100 field of cells individuals within that team, and we'll likely expand that by approximately another 50 cells representatives to make certain that we can get the breadth and depth of prescribing across the two products that are approved today and potentially the atopic dermatitis products. So we will be expanding and that will be initiated shortly. Okay, thank you very much.
spk13: Thank you. One moment please for our next question. And our next question comes from the line of Seamus Fernandez with Guggenheim Securities.
spk20: Hi, this is Colleen for Seamus. Thanks for taking our question and congrats on the quarter. So we're seeing around 6,000 scripts per week for Zureve over the past few weeks. So as a conservative estimate, if we analyze those 6,000 scripts for 48 weeks and assume a 60% gross net by our math, that gives us a little under 100 million for Zureve cells. Are we thinking about this the right way for a conservative minimum for 2024, which also isn't taking the atopic dermatitis launch into account or are there other factors we should be considering for the year? Thanks.
spk11: Yeah, I think I'll let John answer that one.
spk07: Thanks, Frank. Specifically, we're not giving revenue guidance and the 6,000 number I believe you quoted is both cream and foam. As Todd had mentioned, we're seeing early signs of strong sep derm, we're seeing improvement around psoriasis. We're in the early part of the launch. So I think we're standing back and thoughtfully and looking at how that launch is going. We're quite enthusiastic about how the year will turn out, but we're not giving specific guidance on revenue. As it relates to gross to net, just as a reminder, we exited 2023, essentially in the mid-60s. And there is a reset that happens in Q1 as a result of folks deductible reset and as folks also changed their medical plans. So you'll see that probably pick up for psoriasis and sep derm, but we're confident as the year progresses that gross to net will continue to improve toward the end of 2024. And I believe in our script, we
spk15: mentioned our target is in the 50s. Great. Thank you. One moment, please, for our next question.
spk13: And our next question comes from the line of Serge Ballinger with Needham.
spk22: Hi, good morning. Thanks for taking our questions and congrats on the progress. I guess a question for Todd related to gross to net. I think you reiterated your target to be the mid-50s by the end of the year for, I believe it was Zoriv Cream in psoriasis. Just curious, I wish you think about the other products, especially Zoriv
spk19: Foam
spk22: and what will happen to overall gross to nets once the AD indication comes on board and the managed care component also expands, thanks.
spk03: Yeah, thank you. You as mentioned just by John earlier that we're anticipating the second half of the year to achieve that the 50s for the gross to net, that is for the indication of psoriasis. That's too early to comment on Zoriv Foam for septic dermatitis. I think the one signal that I mentioned earlier was relative to the coverage scripts approaching 50% now of the total volume. And then relative to atopic dermatitis, just as a reminder, these are three unique and distinct products have separate NDCs. So therefore they'll have separate unique gross to nets. But relative to the launch, potential launch in atopic dermatitis, the PVMs similar to what happened with Zoriv Foam will treat the AD launch as a line extension, which will be able to support rapid uptake of cover prescriptions
spk15: at
spk03: launch for
spk15: the atopic dermatitis product. Thank you. One moment please for our next question. Our next question comes from the line of Vikram Parohit
spk13: with Morgan Stanley.
spk02: Hi, good morning. Thank you for taking our questions. We had two, one on septum and one on AD. So for septum, could you remind us how many cans of product you expect patients on the foam to work through annually? Understanding it's still pretty early in the launch. And are there any interesting observations you're picking up from the initial phase of this launch on which areas of the body patients are using the product and how much they're using and whether they're using it either as monotherapy or as a combination agent. And then on AD, would just be curious what your latest thinking is on where Zoriv Cream could fit in if approved versus other branded topicals that are or may be on the market by the time Zoriv launches. Sure, yeah. Todd, you wanna maybe take Vikram's
spk10: question?
spk03: Yeah, for the first question relative to the anticipated number of units. So we're anticipating that per patient on average per year, a patient would use one to two septum units. And then relative to, it's a little bit early to be able to tell where patients are using this on the body. Our label's very open relative to anywhere on the body or scalp. And then relative to monotherapy or not. Once again, it's too early to tell specifically how dermatologists will likely be using this product. Although I will mention that there has been a lot of feedback from dermatologists relative to the convenience of this product being a monotherapy. And I think that leads back to patients really yearning for something that's more convenient and not having to use six products on average per week. And so I think that this is one significant difference here of the product to be able to use as a monotherapy highly effective product
spk15: anywhere on body and scalp. Thank you. One moment please for our next question.
spk13: And our next question comes from the line of Sean Kim with Jones Trading.
spk16: Yeah, hi, congratulations. And thank you for taking my questions. I guess one question on Medicaid and Medicare expansion opportunity. So just curious, what are some of the remaining getting steps to realize the expansion opportunity in the managed care? And my second question is about the patient awareness. You mentioned about 17% of patients aware of your branded product. Just curious to hear whether there's a demand for your products has been more on the doctors recommending the products to patients or vice versa, patients kind of requesting the products and your expectations going forward whether that awareness will further increase. Thank you.
spk11: Todd, sorry, but I think those probably both are to you too.
spk03: Yeah, thank you. And just clarification, the first question that was relative to the Medicaid expansion opportunity.
spk11: Medicaid and Medicare both.
spk03: Medicaid and Medicare both, fantastic. Yeah, relative to Medicare, we are currently in negotiations with a couple of the Part D Medicare plans and we're anticipating Medicare coverage at some of those Part D plans to be initiated in the second half of 2024. And in relative to Medicaid, a very similar timeframe. We're also actively talking and working with some of the state Medicaid plans and we anticipate that those plans will come online near the middle of the year to the second half of the year for the Medicaid plans. And then on the other relative to patient awareness and also whether it's a physician or doctor-driven, I think right now it's primarily, for the most part, doctor-driven given just a new product to market. There has not been any new innovation within this space in two decades and the enthusiasm by providers around this product. So I think there's a tremendous push by physicians to their patients to take this product. However, I think over time that paradigm will shift to the patient as we continue to engage more directly with patients, create awareness to patients through a different mode of engagement opportunities.
spk11: Sean, maybe just to clarify for you and the other animals, neither Medicare nor Medicaid are binary coverage decisions, right? So in Medicare, the majority of patients are covered by these Part D plans that are run by various PBMs or insurance companies. And so we'll get coverage with individual Medicare providers just as we have with commercial. It won't all come at once. We'll get a little bit here, a little bit there, a little bit the other place. And then in the case of Medicaid, that's administered as a state program through block grants from the federal government. And so you have to negotiate with individual states for Medicaid coverage. And so again, that will be kind of a piecemeal coverage process, in fact, even more fragmented since you're dealing with such a large number of states.
spk16: Okay, that's very cool.
spk11: Thank
spk16: you for the clarification.
spk13: Thank you. There are no further questions. Thank you for joining our Q-tis today. This does conclude the call and you may now disconnect.
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spk12: I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm
spk01: not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm
spk13: not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I'm not sure if I'm going to be able to do this. I would now like to hand the call over to Derek Cole, Arcudis Investor Relations. Please go ahead.
spk08: Thank you Andrew. Good morning everyone and thank you for joining us today to review 2023 financial results and a business update. Slides for today's call are available on the Investor section of the Arcudis website. On the call today we have Frank Watanabe, President and CEO, Patrick Burnett, Chief Medical Officer, Todd Edwards, Chief Commercial Officer, and John Smither, Chief Financial Officer. I'd 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. We encourage you to review all the company's filings with the Securities and Exchange Commission, including descriptions of our business and respectors. With that, let me hand the call over to Frank.
spk11: Thanks Derek. I'm now on slide five of the deck. We've had a lot of really exciting progress since we last spoke for our Q3 earnings call and I couldn't be more pleased with the Arcudis team and our execution in the quarter, nor more excited about the foundation. These results lay down for progress in 2024. We continue to see growing momentum in the Zareve cream launch and psoriasis as healthcare providers and their patients see how it addresses real needs in their treatment of psoriasis. We've now generated over 165,000 prescriptions and over 10,700 unique prescribers to launch to date as our product delivers positive clinical experience for HCPs and their patients. We continue to make significant progress on our growth to net each quarter with improvement in Q4 over Q3 of a similar magnitude as seeing Q3 over Q2 taking us to an average in the mid-60s for the fourth quarter. The solid growth and prescriptions coupled with continued growth to net improvements drove strong revenue growth in Q4 both versus Q3 and year over year with fourth quarter net revenue of $13.5 million. Coming on top of our progress with Zareve cream and psoriasis, we also received approval for Zareve foam for seborrheic dermatitis in December and launched in late January. I don't think I've ever seen comparable levels of excitement amongst patients and dermatologists as what we're hearing about Zareve foam. We also continue to execute against our clinical and regulatory milestones with a steady flow of successes this past quarter. Patrick will go into a little more details in a minute, but during the quarter, the FDA accepted our supplemental NDA for atopic dermatitis down to the age of six and assigned a target date of July 7, 2024, potentially expanding our portfolio even further. We also released very exciting interim long-term data from our open label study in AD that demonstrated efficacy continues to improve with long-term use out to 52 weeks, along with favorable long-term safety and dependable disease control. We've seen robust, consistent and predictable efficacy across all targeted indications, including psoriasis, sebederm and atopic dermatitis in each of their respective pivotal trials. In addition, in October 2023, the U.S. Patent and Trademark Office awarded the company a new formulation patent that covers a means for inhibiting reformylase crystal growth that is not limited to hexylene glycol. And in November 2023, the company was also awarded a new method of treatment patent covering a topical reformylase formulation with an extended half-life. Both patents do not expire until 2037. And in October, we completed a secondary offering that raised $102 million, putting us in a strong financial position to continue investing in the ongoing launches in Plaxris and sebederm, as well as the potential atopic dermatitis launch later this year, while continuing to the development of our pipeline. Moving on to slide six, a major reason why we're so excited for this year is that we are in the midst of a very significant expansion of the opportunity for topical reformylase, which we expect will translate into a substantial acceleration of our revenue trajectory. You've seen this before, but from the initial approval for psoriasis, the total addressable market for Zareth could grow around tenfold this year alone to over 15 million patients in the United States. We have the right commercial team in place for success, and we have an excellent plan to execute against these opportunities. With that, let me turn it over to Todd to provide some further commentary around the Zareth Cream Launch and psoriasis and update you on how the foam is progressing in sebederm.
spk03: Thank you, Frank. And I'm very enthusiastic about our growing commercial portfolio, recent progress, and the tremendous opportunity I see ahead. Moving to slide eight, the Zareth psoriasis launch is accelerating, and our execution strategies are showing signals that we are able to push the launch trajectory in psoriasis. These efforts also lay a solid foundation for sustained growth in sebederm and potential further growth in new indications upon approval. The NRx and TRX prescription volume is growing every quarter, and Zareth has over 165,000 TRXs launched to date. Fourth quarter 2023, TRXs were up 26% compared to Q3 2023 and over 290% compared to the fourth quarter of 2022. We're starting to see a preference for Zareth relative to the non-steroidal competitor, as evidenced by our steady gains in market share, and eight in 10 Zareth riders are increasing their utilization of Zareth. The new pediatric label expansion down to six years of age incrementally expands our opportunity for growth and further strengthens Zareth's safety and tolerability profile. Refills continue to be an important driver of long-term growth. The number of refills in the fourth quarter increased by around 39% versus the third quarter, and now constitute more than one in three prescriptions, which is in line with what we want and expect to see, given the positive experience patients have with Zareth. I am now on slide nine. There are multiple important dermatology conferences in January. After spending time with dermatologists, MPs, and PAs currently using Zareth Cream, the feedback I received about the product is exceptional. These prescribers spoke to me about their patients being delighted by the results achieved with Zareth. The prescriber feedback is clear that there are some distinct attributes of Zareth Cream that make it attractive. The ability to be used anywhere, once daily dosing, compelling efficacy data, favorable tolerability profile, safety and appropriateness for any psoriasis patient. And these attributes make Zareth Cream an attractive treatment for patients with different types of needs. The patient who is concerned about steroids, the patient who has been cycling through various topicals, or ones that are exploring different treatments to find that works for them long-term or to manage flares. We know that psoriasis patients have differing needs, depending on where they are in their journey, and see that Zareth Cream can really be a solution for most of these patients. I'm now on slide 10. The team has been focused on three pillars of commercial success for sustaining Zareth Cream growth in psoriasis. Firstly, driving ACP awareness and use. The prescriber base is growing steadily, with now over 10,700 unique prescribers since launch. Our experienced field sales team is focused on high-volume geographies. The field team continues to deliver 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 a large body surface area. Secondly, patient engagement and positive use experience. Refill volume has increased to 38% of total volume, and Zareth patient awareness continues to improve. And finally, the broad, high-quality access in commercial and anticipated Medicare-Medicaid coverage creates the opportunity for more patients to experience Zareth. Zareth's differentiated pricing and access strategy continues to resonate with payers, with over 132 million commercial lives having access to Zareth Cream. The Arcutus team successfully secured coverage for Zareth Cream with all three large PBMs in the U.S. within 12 months of the launch. And we anticipate further improvements in Zareth commercial coverage throughout 2024. And PAs and step edits are typical for branded products in dermatology. And for Zareth, this process is now well understood by pharmacies and dermatology offices. And finally, we are seeing very encouraging trends in percentage of cream prescriptions being covered by insurers, with a clear opportunity to expand on this by working with contracted pharmacy partners. From my experience, I am confident in our ability to continue to improve our approach to net. We saw very good improvements in growth to net during Q4 and expect that progress to continue in subsequent quarters. With us approaching our target growth to net in the 50s for the psoriasis indication by the second half of 2024. One very large incremental opportunity to accelerate prescription growth is the expansion into Medicaid and Medicare, which we expect to begin as early as 2024. Roughly a third of psoriasis patients and nearly half of septum and atopic dermatitis patients are on Medicare or Medicaid. So this is a very important opportunity for us. Zareth's pricing falls below the CMS specialty threshold tier, unlike other branded topicals. So we are well positioned to access these segments. Now moving on to slide 11. We are seeing a tremendous early response to the launch of Zarethome, the first drug approved for septum dermatitis with the new mechanism of action in over two decades. As you have likely seen in ITUVIA data, we have a strong start to the launch with a very positive launch trajectory. The first approved treatment unconstrained by severity, duration and location. Zarethome is different than anything else derms or patients have seen for this disease. With treatment success in eight and ten patients in our pivotal trial, with over half of these patients completely clear in just eight weeks. Significant impact on itch, most bothersome symptoms of this disease with improvements seen as early as 48 hours. Simple, once daily leave in application that's much more convenient than any other option. And taken together, we believe Zarethome can be the new standard of care in managing septum. I'm now on slide 12. With a product profile offering rapid, dramatic disease clearance and significant reduction in itch with a simple single treatment, HCPs and patients are very enthusiastic about the availability of Zarethome. Eighty-one percent of survey prescribers view the Zarethome profile as very compelling or compelling. They also recognize the attributes of applicability to any part of the body. The uniqueness of the vehicle and critical efficacy needs for this patient type of rapid response of itch and erythema, which then helps to reduce the number of treatments in the regimen and potentially leads to improved compliance. On slide 13, as mentioned previously, we have secured access with the three national PBMs who recognize Zarethome as a line extension under the Zarethome contracts. This has translated into an increased volume of covered prescriptions early in the launch period, with covered prescripts already near 50 percent of total volume. We continue to work with the downstream health plans, leading them on board, and this accelerated coverage will translate into a more rapid improvement in growth to net, compared to what we saw with the cream launch or what is knowledgeable with the new germ products. Finally, all the key EMRs already have Zarethome available for nocturnal prescribing. Moving to slide 14, building on the strength of label and product profile, we are confident that we have the ingredients in place for successful launch of Zarethome in SEDDerm. With relationships already built with dermatologists, a field team trained on the value proposition and ready to promote and educate, contracted pharmacies in place, familiarity with the copay card and processes that go with the product, and access with PBMs to assure patients get the drug. I look forward to updating you further on our commercial progress throughout the year. We are also looking forward to upcoming launches and new indications, and so I will hand it over to Patrick to cover that.
spk09: Thanks, Todd. I'm extremely proud of the team's performance in delivering on the promise of topical flumelast in the dermatology community and hitting all our timelines with regard to our regulatory milestones. On slide 16, I'm going to cover these according to indication with psoriasis first. Here we have approval down to the age of six after we have expanded the indication, and the opportunity in pediatrics to reach the two to -year-olds will be the subject of a future FDA review. Next for SebDerm, with our approval in December and the recent launch, physician excitement is palpable and the feedback at medical congresses has been very positive. The profile here is unprecedented efficacy with a -a-day foam in a market as big as psoriasis with no innovation in decades and no branded competition. So moving on to atopic dermatitis, as Frank mentioned, the FDA accepted our supplemental NDA for rafflumelast cream as a potential treatment for atopic dermatitis for patients down to the age of six, and they assigned a PDUFA action date of July 7th of this year. And finally, we're also expecting to submit another SNDA with the FDA for xerif foam in scalp and body psoriasis in the second half of 2024. On slide 17, I want to highlight some recently released pooled data from our phase III AD studies in tegumet 1 and 2. And it's quite notable and highly unusual that over 90% of patients saw improvement in their symptoms in just four weeks, and nearly 70% seeing at least a 50% improvement. Looking at the more demanding EZ75 hurdle, almost 45% of patients achieved this large improvement at week four. And encouragingly, in the long-term study which we've released but aren't showing here, at the end of 56 weeks, two out of three patients had achieved a 75% improvement. It's really exciting to see where we have a high proportion of patients responding early and then seeing an increased benefit over time with long-term treatment. And in that long-term study, we also looked for the first time at our ability to control the disease with a less frequent maintenance regimen, where patients were switched to twice weekly treatment if they reached complete clearance. We're really happy about the response there. This regimen fits nicely with the current clinical practice, and these data have really resonated with dermatologists. We're excited about the Rufunos-Cream clinical profile for AD and the significant opportunity in this large and growing market. Dynamics here at AD are favorable towards rapid adoption and share some of the positive tailwinds as sub-derm. In pediatric patients especially, here in AD there's a propensity to adopt non-steroidals higher than in the psoriasis patient population, and that's largely driven by parents' avoidance of steroids. So moving on to slide 18, I want to highlight the itch response across our portfolio of products. So here we're showing WINRS, or Worst Itch Numeric Grading Scale, results of our Phase III studies. These are pooled results for psoriasis dermis and the AD entegument studies, and these are individual study results for stratum and erector. Itch is a primary symptom for these conditions and a key driver of our quality of life impact. It says rave cream and foam at .3% and topical rufunolast .15% cream for AD provided consistent and rapid improvements in itch across psoriasis, sub-derm, and AD respectively, with improvements as early as $24 to $48 as compared with vehicle treated patients. This includes scalp psoriasis in the erector study, which is particularly difficult to control, and only four weeks of treatment in the entegument studies. Across indications, we have a significant proportion of patients achieving an itch-free state. And with that, I'll pass it over
spk15: to John. Operator, can you hear me? This is Frank. Yes, I can hear you
spk11: now. While we're working on John, I'll take over for him for just a minute. So if you're listening, so I'm on slide 20. So we achieved $29.2 million in net product revenue for Zuri for the full year 2023, with $13.5 million of that in Q4, reflecting a 67% growth from Q3 to Q4, which comes on top of the approximately 70% sequential growth we saw from Q2 to Q3. This was driven by substantial growth, growth in net, excuse me, percentage improvement down to the mid-60s and the team's success in pulling through covered prescriptions. We also saw healthy prescription growth in the quarter. So looking forward to 2024, we expect continued prescription growth and growth in net improvements for Zuri, criminoceriasis, and continued prescription momentum and GTN improvements for Zuri foam. Although there will likely be a temporary erosion in psoriasis growth demand improvements in Q1-24 versus Q4-23 due to the typical deductible resets and patients changing their coverage that always occurs at the beginning of the year. Turning to slide 21, you can see the strong performance in the fourth quarter with net product revenues for the quarter of $13.5 million, up over $10 million from Q4 of 22. R&D expenses for the fourth quarter were $23.8 million, which is down significantly from Q4-22 due to continued decrease of development costs on topical reform last programs. And recall that our R&D expense includes research, operations, and medical affairs spend. On slide 22, looking at full year, full year total revenues of $60 million with $29.2 million in net product revenues and $30 million in other revenues related to the upfront payment in connection with the HWADONG collaboration and licensing agreement we received in Q3. R&D expenses for full year were $111 million, which is down $70 million approximately due to the one-time $30 million fee associated with the due census acquisition in 2022, winding down of our major reform last phase three studies and lower pre-commercial production. We expect full year 2024 R&D expense to decline meaningfully versus full year 2023 as we continue completing the few remaining phase three studies, continue with regulatory filings, reduce our pre-launch production costs, and maintain our medical affairs activities to support the launches. SG&A expenses for the year were $185 million primarily due to higher commercialization expenses year over year driven by continuing investments in Zareef Cream and preparing for the ongoing launch of Zareef Foam and the potential upcoming launch in atopic dermatitis, if approved. As we head into 2024, we expect SG&A to increase over 2023, which aligns with the investment behind our SEDDM launch and preparations for the atopic dermatitis launch, including our previously announced incremental expansion in Salesforce. We will continue to focus on appropriate investments to support our commercial activities. Launching drugs properly requires substantial investments in staff and promotional investment and having multiple launches in a short period of time really magnifies these resource demands. It's important to note that we have made concerted efforts to adjust our operating expenses to reflect our transition from being exclusively a pre-commercial company to a commercial enterprise and ensuring we invest appropriately in current launches and if approved, ensuring the same for our future launches. We don't want to be in a position of underinvesting and harming the trajectory for the ongoing launches in psoriasis and SEDDM or future launches, if approved. Earlier in the year, we undertook a reorganization and reprioritization of non-commercial efforts to align with our commercial execution focus in 2024, which will result in aggregate approximately $50 million of reduced expenses over the next two years as compared to previous internal forecasts. You can expect us to continue to focus on cash burn as we look for opportunities to maximize our OPEX while making continued progress on maximizing the Zareve opportunity across multiple unique indications. A top priority for our team is being good stewards of the investor capital entrusted to us and we believe we have demonstrated an excellent track record thus far. We have made appropriate levels of investment that established our pipeline, achieved nine positive Phase III clinical trials and now two FDA approvals with a third potentially coming midyear while launching two products to date and if approved, another in the second half of 2024 and a fourth in 2025. On slide 23, our final slide, on the balance sheet, we had cash and marketable securities of $272.8 million as of December 31. And as I mentioned in a previous slide, our current capital enables us to continue to invest appropriately in commercial initiatives. We also remain confident about concluding an outlicensing deal in Japan to bring in additional non-dilutive capital, which would further extend runway and largely address the capital requirement covenant with SLR. Additionally, we are actively pursuing a primary care partnership and are seeking and seeing early interest from our efforts there. So that's it for our comments today. You know, if I step back for a minute, you know, we founded Arcudis with a vision of bringing meaningful innovation to the medical dermatology space, especially the topical space. With our second launch in less than 18 months, I'm proud that our team is making that vision a reality and in the process is helping a growing number of people suffering from dermatologic conditions. As we continue to execute on the psoriasis and sebederm launches and hopefully adding the atopic dermatitis launch later this year, we look forward to helping millions of people, allowing us to create additional shareholder value. We are confident that 2024 will be a transformational year for Arcudis. And with that, we will open it up for Q&A.
spk13: Thank you. 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, press star 1-1 again. One moment, please. And our first question comes from... Frank, I think we're
spk05: back on.
spk13: Tyler VanHuren with TD Cowan. Your line is now open.
spk23: All right. I think that's me. Good morning, guys. Thanks for taking the question. So the sebederm prescriptions for Zureve foam have gone vertical very early in the launch and have reached levels that Zureve, Cream, and Vitama took significant longer to reach. So I understand that having coverage from day one is a huge benefit and there's not a direct competitor, but what else would you attribute the success to early on? And do you think Zureve foam could ultimately end up being significantly larger than the Cream?
spk10: Yeah,
spk11: I think maybe, Todd, if you could take that and then Patrick, see if you have any additional comments after Todd's comment from a commercial standpoint.
spk03: Yeah, thank you, Frank. And yeah, as mentioned, we're very pleased with the uptake of Zureve foam. And I mean, you know, with the weekly demand trends, I'd say it's too early to comment on how much of that is coming from a warehouse of patients. But I would say that one big driver of this initial uptake is just that, that it's a ready pool of patients that are out there. And these patients have been waiting for Zureve foam. They've been waiting for a more convenient, more effective treatment. And so I think that that's been driving this. But, you know, we expect continued strong growth of the product, but I just cautioned that a linear progression based on the rate trend is probably overly optimistic. But I think that there's a long runway for Zureve foam and we're looking forward to continuing to grow this product.
spk00: Patrick,
spk09: any additional
spk03: medical thoughts?
spk09: Yeah, go ahead. Yeah, I think just kind of adding the perspective of how this might fit into practice for dermatologists. You know, seborrheic dermatitis patients can be a challenging patient type in the dermatology practice just because you've had them in your practice for 10, 15 years sometimes. You know, we know that there's a very long runway for patients before they actually get to a diagnosis. And oftentimes they've they've tried everything that's out there. And in this space where we haven't really had any innovation for 10, 20 years, remember, this is the first new mechanism of action for a prescription topical in over two decades. Yeah, I think there really is a lot of interest in having a new therapy. And that translates into a level of frustration for the dermatologist that was kind of pent up prior to this, because when a patient would come back in, they just had nothing to offer them that wasn't a topical antifungal or topical corticosteroid. So, you know, I think that this is simply a component of solving an unmet need where there are patients who are dissatisfied with the treatment and, you know, health care providers who haven't really had anything new to offer. And we've heard that in anticipation of the approval and launch, you know, for the two or three years while we were running our phase three studies looking for the FDA to approve the drug, that there was a high level of anticipation
spk06: for this for those reasons.
spk13: Thank you. One moment, please, for our next question. And our next question comes from the line of Oye Ear with Mizuho.
spk18: Hey, guys. Yeah, thanks for taking my question. So just on the launch, the septum launch, could you, you know, you speak of warehousing effect. Are you sort of suggesting primarily that these are kind of patients who have limited options? And I guess, are you seeing what kind of patients are you seeing generally? Are they they tend to be more on the severe side or the mild side? And could you sort of just maybe provide some of the demographics a little bit if you have such data? Yes, that's my first question. I'll follow up with a second question.
spk11: Thanks. You know, I think that the point we're trying to make is, you know, think about it. It's been over 20 years since there was a truly new drug for seborrheic dermatitis. And so, you know, there is a very large pool of patients as Patrick or Todd mentioned, excuse me, who have been eagerly awaiting Zuree Phelms availability. And, you know, I think some of the very early demand is probably these these patients who have been, as Patrick mentioned, you know, have been cycling for three years and have been just sitting in the office. And now all of a sudden, the doctor has a new option and they're going to put them on Zuree Phelms. So, you know, we don't we think that there is this pool of readymade patients that is helping the early launch. But we want to make sure that folks don't think that that that pool will exist forever with, you know, this this constant stream of very large patients. Having said that, you know, our research suggests that dermatologists see about 75 severe patients a month. So it's a very large population of patients which should sustain long term growth for us. In terms of your question around the demographics, I think it's really too early for us to have any data on that. We'll be looking at, you know, adoption and where doctors are using it as we get farther into the launch. And we'll be able to share some of those data in the future. But at this point in the game, we don't have any data on that yet.
spk18: OK, and maybe you can help us understand a little bit. So you during the earlier call, the launch call, you indicated there were a script some that were waiting at the pharmacies. Are you still seeing significant number of scripts that have not been have not been filled or shipped to consumers or at this point? These scripts, you know, they come in and they are, I guess, readily shipped. I'm just wondering if there's a large delta and maybe along that line, could you kind of also help us understand in your Zaree direct program? Is there any differences between the cream and the foam in terms of getting it processed? And if there's any, yeah, just wanting a little more clarity on that. Thanks. Sure. Yeah, sure. Todd, can you take those two?
spk03: Yeah, absolutely. As mentioned prior to the commercial launch, there was a number of prescriptions that were sitting at the pharmacy. But those prescriptions have all been filled and distributed to the patient. So we don't see what I'll call a warehouse of prescriptions sitting currently at the pharmacy today. And then relative to our Zaree direct program, I think this is a big strategic advantage for us is that the program is identical. It's the same program for Zaree cream and psoriasis or for Zaree foam and seborrheic dermatitis. And that creates a great efficiency for the dermatology offices, given that two unique products for two distinct patient populations, psoriasis and sebderm, but one process in fulfilling that prescription. And so that is a common process across across both products.
spk17: OK, thank you.
spk13: Thank you. One moment, please, for our next question. And our next question comes from the line of Chris Shibutani with Goldman Sachs.
spk24: Hi, thanks for taking our question. This is Stephen on for Chris. One on the subderm launch, curious if we should expect any inventory or channel stocking effects in the first quarter. And then as far as the commercial team goes, do you believe the team is currently right size for the psoriasis and subderm opportunities? And if we should anticipate any changes ahead of atopic derm? Thank you.
spk10: Yeah, John, do you want to maybe take the channel question and Todd, could you address the team?
spk15: With respect to Q1, no, we're not anticipating
spk07: any channel build up with respect to Q1.
spk03: Yeah, and then a question relative to being right sized, especially for the potential atopic dermatitis launch. In anticipation of that launch, we will expand our field cells organization. Today, roughly, we have around 100 field cells individuals within that team and we'll likely expand that by approximately another 50 cells representatives to make certain that we can get the breadth and depth of prescribing across the two products that are approved today and potentially the atopic dermatitis products. So we will be expanding and that will be initiated shortly. OK, thank you very much.
spk13: Thank you. One moment, please, for our next question. And our next question comes from the line of Seamus Fernandez with Guggenheim Securities.
spk20: Hi, this is Colleen for Seamus. Thanks for taking our question and congrats on the quarter. So we're seeing around 6,000 scripts per week for Zareve over the past few weeks. So as a conservative estimate, if we analyze those 6,000 scripts for 48 weeks and assume a 60% grossness by our math, that gives us a little under 100 million for Zareve sales. Are we thinking about this the right way for a conservative minimum for 2024, which also isn't taking the atopic dermatitis launch into account? Or are there other factors we should be considering for the year? Thanks.
spk11: Yeah, I think I'll let John answer that one.
spk07: Thanks, Greg. Specifically, we're not giving revenue guidance. And the 6,000 number I believe you quoted is both cream and foam. As Todd had mentioned, we're seeing early signs of strong septum. We're seeing improvement around psoriasis. You know, we're in the early part of the launch. So I think we're standing back and thoughtfully and looking at how that launch is going. We're quite enthusiastic about how the year will turn out, but we're not giving specific guidance on revenue. As it relates to gross to net, just as a reminder, we exited 2023 essentially in the mid-60s. And there is a reset that happens in Q1 as a result of folks deductible reset and as folks also change their medical plans. So you'll see that probably pick up for psoriasis and septum, but we're confident as the year progresses that gross to net will continue to improve toward the end of 2024. And I believe in our script we
spk15: mentioned our target is in the 50s. Great. Thank you. One moment, please, for our next question.
spk13: And our next question comes from the line of Surge Ballinger with Needham.
spk22: Hi, good morning. Thanks for taking our questions and congrats on the progress. I guess a question for Todd related to gross to net. I think you reiterated your target to be the mid-50s by the end of the year for, I believe it was Zoriv Cream in psoriasis. Just curious how we should think about the other products, especially Zoriv
spk19: Foam,
spk22: and what will happen to overall gross to net once the AD indication comes on board and the managed care component also expands.
spk03: Thanks. Yeah, thank you. As mentioned just by John earlier that we're anticipating the second half of the year to achieve that the 50s for the gross to net. That is for the indication of psoriasis. It's too early to comment on Zoriv Foam for septum dermatitis. I think the one signal that I mentioned earlier was relative to the coverage scripts approaching 50% now of the total volume. And then relative to atopic dermatitis, just as a reminder, these are three unique and distinct products have separate NDCs. So therefore they'll have separate unique gross to nets. But relative to the launch, potential launch and atopic dermatitis, the PBMs, similar to what happened with Zoriv Foam, will treat the AD launch as a line extension, which will be able to support rapid uptake of cover prescriptions at launch for
spk15: the atopic dermatitis product. Thank you. One moment, please, for our next question. Our next question comes from the line of Vikram Paroit
spk13: with Morgan Stanley.
spk02: Hi, good morning. Thank you for taking our questions. We had two, one on septum and one on AD. So for septum, could you remind us how many cans of product you expect patients on the foam to work through annually? Understanding it's still pretty early in the launch. And are there any interesting observations you're picking up from the initial phase of this launch on, you know, which areas of the body patients are using the product in, how much they're using, and whether they're using it either as monotherapy or as a combination agent. And then on AD, we'd just be curious what your latest thinking is on where Zoriv cream could fit in if approved versus other branded topicals that are or maybe on the market by the time Zoriv launches. Thanks. Sure. Yeah, Todd,
spk11: you want to maybe take Vikram's question?
spk03: Yeah, for the first question, relative to the anticipated number of units. So we're anticipating that per patient on average per year, a patient would use one to two septum units. And then relative to it's a little bit early to be able to tell where patients are using this on the body. It will, you know, our label is very open relative to anywhere on the body or scalp. And then relative to monotherapy or not. Once again, it's too early to tell specifically how dermatologists will likely be using this product. Although I will mention that there has been a lot of feedback from dermatologists relative to the convenience of this product being a model therapy. And I think that leads back to patients really yearning for something that's more convenient and not having to use, you know, six products on average per week. And so I think that, you know, this is one significant differentiator of the product to be able to use as a model therapy, highly effective product anywhere
spk15: on body and scalp. Thank you. One moment, please, for our next question.
spk13: And our next question comes from the line of Sean Kim with Jones Trading.
spk16: Yeah, hi, congratulations. And thank you for taking my questions. I guess one question on Medicaid and Medicare expansion opportunity. So just curious, what are some of the remaining getting steps to realize the expansion opportunity in the managed care? And my second question is about the patient awareness. You mentioned about 70 percent, 17 percent among patients aware of your brand product. Just just curious to hear whether there's a demand for your product has been more on the doctors recommending the product patients or vice versa patients kind of requesting the products and your expectations going forward, whether that awareness will further increase. Thank you.
spk11: I'm sorry, but I think those probably both are to you,
spk03: too. Yeah, thank you. And just clarification. The first question that was relative to the Medicaid expansion opportunity. Right.
spk11: Medicaid and Medicare both. Medicaid
spk03: and Medicare. Fantastic. Yeah. Relative to Medicare. So, we are currently in negotiations with a couple of the the party Medicare plans, and we're anticipating Medicare coverage at some of those party plans to be initiated in the second half of 2024. And a relative to Medicaid, a very similar time frame. We're at we're also actively talking and working with some of the state Medicaid plans, and we anticipate that those plans will come online near the middle of the year to the second half of the year for the Medicaid plans. And then on the other relative to to patient awareness and also whether it's a physician or doctor driven. I think right now it's primarily the most part doctor driven given just a new product to market. There has not been any new innovation within this space in two decades and the enthusiasm by providers around this product. So I think there's a tremendous push by physicians to their patients to to to take this product. However, I think over time that paradigm will shift to the patient as we continue to engage more directly with patients, create awareness to patients through a different mode of engagement opportunities.
spk11: And Sean, maybe just to clarify for for you and the other animals, you know, neither Medicare nor Medicaid are binary coverage decisions. Right. So, you know, in Medicare, the majority of patients are covered by, you know, these part D plans that are run by various. PBMs or insurance companies. And so, you know, we'll get coverage with individual Medicare providers, just as we have with commercial. It won't all come at once. We'll get a little bit here a little bit there a little bit the other place. And then in the case of Medicaid, you know, that's administered as a state program through block grants from the federal government. And so you have to negotiate with individual states for Medicaid coverage. And so, again, that will be kind of a piecemeal coverage process. In fact, even more fragmented since you're dealing with such a large number of states.
spk16: Okay, that's very cool.
spk11: Thank
spk16: you for the clarification.
spk13: Thank you. There are no further questions. Thank you for joining our Q. This does conclude the call and you may now disconnect.
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