Conference Transcript - ARQT 2026-03-02

Tyler Van Buren, Analyst — TD Cowan

All right. Good afternoon, everyone. Tyler Van Buren here, Senior Biotech Analyst at TD Cowan. Thank you very much for joining TD Cowan's 46th Annual Healthcare Conference. For our next session, I'm very excited to host Arcudis for a hybrid presentation and fireside chat style Q&A. It's my pleasure to introduce Frank Watanabe, the CEO, and Todd Edwards, the Chief Commercial Officer of Arcudis. Frank and Todd, it's a privilege to have you here. Thank you for joining me. I'll go ahead and pass it over to you for the presentation.

Frank Watanabe, CEO

Always a pleasure. We'll try and keep the presentation part short so we can talk more, but standard legal disclaimer. We just had our quarterly earnings call last week, and these slides were all in the slide If anyone's interested, it's on the website, but just maybe a couple of recaps. We had a very strong Q4, very strong 2025, printed 127.5 for the fourth quarter, which was about 15 million, I think, over consensus, as I recall. so that was 372 for the year which was a really nice number I think from our standpoint you can see the growth you know doubling effectively in our TRX is last year we have now grown we have almost 50% of the branded non-steroidal market share so that's you know us and the other branded non-steroidal topicals on the market I won't go through all of the list of achievements on the other side but you know I think one of the things that has been a hallmark of this company from the outset has been very strong execution very strong on time execution and the team continued that throughout 2025 with a couple of additional approvals as well you know and the q3 earnings call we we laid out sort of framework for how we think about sustaining the growth of this company and we put that into three broad buckets growing our existing Zareev business expanding our Zareeve business and then building our pipeline and this is just highlights of some of the concrete actions that we've taken around each one of those dimensions of our strategy in the last quarter or so on the growth side you know we reported very very good data from the integument infant trial looking at Zareeve in three to twenty four month olds and we have said that we plan on finding an NDA for that in the second quarter of this year we also announced an expansion of our dermatology sales force for about 20 percent and Todd can go into a little more detail later about the expansion and why we're doing that and finally we announced excuse me that we were ending our primary care partnership and we were taking that in-house and building our own primary care and pediatric dedicated sales force in addition to our derm specialty sales force so some very nice concrete action on the growth front and we've got more to come in 2026 as well. On the expand side, you know, we announced that we were going to start looking at additional uses for Zarev beyond our currently proved indications. We have ongoing phase two trials right now in HS and vitiligo. I think the early case reports from both of those diseases are very, very promising. We think we've got a very compelling value proposition for patients with Zarev in those indications. And we're also currently looking at other indications where clinicians have told us, hey, Zareev works here, and trying to decide which ones of those would be worth running POC studies on and potentially moving into phase three as well, which is really the point of us doing the POC studies. And then lastly, on the build side, we continue to advance ARQ-234, which is our very novel treatment for atopic dermatitis. We will have that in the clinic this quarter, so sometime in the next four weeks, by definition. And we're really excited to get some data from that you know there was another company that was pursuing this target as well put out some very good data on the target which led to our excitement about the target and i think with some of the changes in the systemic space in atopic dermatitis in particular you know the developments with the ox 40s i think this this could be a very very compelling new opportunity in the atopic dermatitis space so i think the next one i'm going to turn over to todd yeah thank you frank shifting gears to net revenue you can see we had a very strong fourth quarter with 127.5 million in net revenue.

Todd Edwards, Other

This is 29 percent quarter over quarter growth versus Q3. Within that quarter over quarter growth, it was some robust demand growth of 19 percent. Important thing about that demand growth is the entire portfolio grew. All products within the portfolio grew Q4 versus Q3. In addition to that, we continue to manage and maintain our gross net net within the 50s, and as Frank mentioned, for the full year, it was $372 million. As we roll forward, you know, say we look at 2026 and Q1, we do expect the typical seasonality, and the way I'll frame that is that we see the copay deductible resets, a little bit of the refills are pulled in from Q1 to Q4, and we did have a little bit of an impact due to winter storm fern for the q1 but nonetheless we expect our growth in that to be stable within the 50s throughout 2026 and looking forward to a very strong year switch into this is a very important slide here looking at some of the data relative to the non-steroidal topical market as well as steroids on your left we'll start there we'll look at the non-steroidal topical market You can see in the yellow the robust growth of Zareeve over several quarters. You look at the gray line, that's the total non-steroidal topical market. And the bottom, the steroid market. So what's important here is to see the acceleration in Zareeve as we continue to promote and engage in steroid conversions. That's where our opportunity sits. And the market is for our continued growth versus the steroid market being basically flat to declining. So really good, I'm saying, signals relative to steroid conversion and Zareeve's growth. In addition, the non-serototopical market continues to grow. Moving to the center, there were 24 million topical prescriptions written in dermatology for the three inflammatory skin diseases that Zareva's indicated for. It's important to note here the non-serototopicals market is now 7%. Last time we showed this a few quarters ago, it was around 4%, so there's good growth for the non-serototopical market. but also importantly if you look at the 64 that's of top topical steroid prescriptions so a robust opportunity for that steroid conversion you look at the 19 that's ketoconazole which is important to our separate dermatitis indication and we can continue to transition those patients over to zarive so if you look at the seven percent growth there um the share on the the market if go to the far right this is the market share within the non-steroid topical market you can see that zarive has a very leading market share so as we move this stairway conversion

Tyler Van Buren, Analyst — TD Cowan

as a non-steroid topical market grows we're getting a lion's share of that growth that lines up to to zarive so once again great indicators here relative to the performance of zarive and topical steroid conversion i think that's i think that's it it's on the slides fire away thanks for the presentation so the q4 results that you elaborated on really surprised people to the upside people thought you would have pre-announced earlier in the year but you wanted to wait just before our conference which i appreciate but can you elaborate on the health of the franchise going into 26 and which demand drivers you think are most durable as we think about continued growth?

Todd Edwards, Other

Yeah, I'll take that. So going into 2026, I think it's important that we have substantial organic growth and momentum as we move into 2026. And what I mean by that is in the fourth quarter, we did see a robust NRX growth with Zuri, which is very important for our business. In addition to that, we're going to expand the dermatology sales force by 30 representatives. That will take us to a footprint of 160 representatives within dermatology. The primary reason that we're expanding the dermatology sales force is to be able to have a higher frequency on the mid-decile prescribers. With the prior launches that we've had with Cereve, our frequency has really been focused on the high-decile prescribers because that's where you see the early adoption of innovative branded products. And we've had great success there. So we want to be able to have higher frequency on the mid-deciles. Why not diluting frequency on the high-deciles? And therefore, we're going to expand by 30 representatives for the field sales organization to continue to drive that growth in 26.

Frank Watanabe, CEO

And then I might just add, we just announced a partnership with Max Homa, a PGA golfer, to raise awareness about seborrheic dermatitis specifically, and Zareev, he's a Zareev, very satisfied Zareev patient. As I mentioned before, we're taking over primary care, so we'll be building out our primary care team and I think we'll eventually see some significant growth there. And then I think it's really notable that January 1, we picked up about a third of all Medicare lives now have access to Zareev, and we're the only branded topical on the Medicare formulary. So I think as time goes on, that will also become a contributor to growth. So we've got a lot of catalysts coming up in 26 on the commercial side. And then on the R&D side, we expect approval in plaque psoriasis for ages two to five in end of June. And then we will file for atopic dermatitis in three to 24-month-olds in the second quarter. We'll see how quickly the FDA reviews that file. But, you know, I think that will also be an important driver of growth for us going forward.

Tyler Van Buren, Analyst — TD Cowan

Right. So all of that led to your increase in the annual guidance on the back of the Q4 results. But, you know, you reiterated your confidence in Zareef reaching five to 20% of the 24 million prescriptions written across psoriasis, subderm, and AD. You're currently at three to three and a half percent probably.

Frank Watanabe, CEO

So we all know what that would due to the 500 million or almost 500 million of guided sales um what do you think needs to happen over the next few years for that inflection to occur for you guys to reach 15 plus of the 24 million prescriptions yeah i mean i think as we look at this market the slide says it all here right the opportunity is conversion of topical steroids right that's where most of the patients are uh it's what you know two-thirds of all the scripts are topical steroid patients uh and so So that's a patient that's already in a dermatologist's office, is already receiving prescription topical treatments, but they're on a less than ideal treatment. And I think we've seen in the last year or so, really, even just since this time last year, a fairly significant shift in discussions in dermatology from steroids are fine, we know what we're doing, we can manage this, to we really need to rethink what we're doing with these topical steroids. Todd and I have probably been to four or five medical conferences since January 1 already. derms like early year meetings. And, you know, it's a consistent drumbeat that you're hearing from the stage over and over and over again, coupled with, I think, a growing level of concern in the general public fed by TikTok and Instagram and things like that about steroid withdrawal syndrome, about all the safety effects with steroids, which is just amplifying the existing steroid phobia in the general public. So all of those things, I think, combined really are tailwinds for us in driving the steroid conversion. And as Todd said, you know, given our share of the non-steroidal market, we differentially benefit from that shift as it happens. But that's really going to be the key. You know, you think about it, we're sitting at, as you said, three and a half percent today. We go to 15 percent. It's simple math. We're a multi-billion dollar drug at that point.

Tyler Van Buren, Analyst — TD Cowan

Yep.

Todd Edwards, Other

So you've highlighted continued momentum across all SKUs, but just maybe elaborate on that how do you think about portfolio mix evolving over time and you expect incremental growth to come from all skews or some skews going to be bigger than others yes so first we we expect growth from all skews as we roll forward but if you look at today relative to the breakdown between the skews first is the foam which is about 50% of our business today that's primarily because there's there's two indications there separate dermatitis as well as scalp and body psoriasis, and that the foam is a highly differentiated product with the foam formulation. From there, you can take the Zareve Cream 0.3% for psoriasis, as well as our 280 products, the Zareve 0.15% and 00.5%. Those are about equal. However, we do see the foam continuing to grow and be a leader within the SKUs, but also robust growth from the atopic dermatitis products because that market is so big but nonetheless all three skews will grow over time and uh given um the approval in ad potentially later in the year um can you talk about that opportunity relative to uh the younger patients and psoriasis and how you're thinking about those launches yeah so in in psoriasis uh psoriasis is actually fairly uncommon in kids um that's one of the challenges with doing studies is it's really hard to find the patients but there isn't anything

Frank Watanabe, CEO

approved currently for the group right and that's really why the FDA pushed us to study it in such young kids you know normally you study it down to 18 maybe 12 and they're like no no no we would just study it down to two okay so you know I feel very confident about the approval I don't think it's going to be a major catalyst in and of itself but I think there's also a halo on the overall business you know if it's proved down to two it you know it really must be safe for my patients i think the more exciting opportunity on the pediatric side is the atopic dermatitis two to five which we already have and we're growing and then the 83 to 24 month old there's hardly anything approved by the fda in three to 24 month olds it's basically just a couple of topical steroids and if you're a parent that's the last place that you want to use a steroid right because of all the safety risks of of a steroid on a very young kid so being able to have a very safe very effective once a day i think equally important or also very important option for the three to 24 month kids is going to be a big hit we know already uh just from you know the release of our top line data the pediatricians and the pediatric dermatologists are just chomping at the bit to get their hands on this drug for their patients in the uh 82 to 5 are you seeing existing scripts there and are those coming from peds even though you guys haven't really fully focused on those practices yet with your sales force expansion yeah we do we see we see um one we're very pleased with the and very encouraged with the growth of the 0.05 for two to five year olds we do see a primary

Tyler Van Buren, Analyst — TD Cowan

driven by dermatologists but we see scripts within the pediatric sector as well got it and as we think about uh your pede sales force expansion as well as the 20 expansion of the derm sales force How long do you think it's going to take to get a meaningful impact on sales from those expansions?

Todd Edwards, Other

Yeah, with the Dermatology of Salesforce, our goal is to have the Dermatology Expansion of Salesforce hired, onboarded, and in the field by July 1st. We typically see about three months from the time that Salesforce has launched, the time to impact. With primary care and PDs, we're in the midst of recruiting for that. we likewise want to have that sales force of 30 sales personnel hired and launched by july 1st but we expect a longer time to be able to impact that likely the latter half of back half of the of the year for the pcpmp it's a little bit more time to get into those offices establish our shelf and get the right frequency going and i think it's important you know to just remind investors that that this initial tranche of 30 or so primary care uh team uh is as a pilot right they're gonna cover 4 000 roughly so a very small chunk of that market as we work out the kinks and figure

Frank Watanabe, CEO

out our go-to-market strategy we will probably scale that into more and more pediatricians and pcts um you know by taking this approach we can scale it in a way that's that's accretive to us versus building it all out at once. But as that expands, that will also add to the contribution from primary care and pediatrics.

Tyler Van Buren, Analyst — TD Cowan

And I guess we should know if it's accretive probably by the end of the year?

Frank Watanabe, CEO

I don't have any doubt that it's going to be accretive. The question is going to be how quickly it becomes accretive and how accretive it is, which is going to drive then how big the ultimate primary care opportunity is. But there's way too many patients in that population for it not to be worthwhile as to it.

Todd Edwards, Other

Yeah, if you think of the total patient population, about across the three inflammatory skin diseases, 50% of it sits in derm and 50% of it sits in other. And the bulk of that other is within primary care and pediatrics. And so we're gonna take a very focused targeted approach to the most highest opportunistic providers with this 30 cells team personnel team.

Tyler Van Buren, Analyst — TD Cowan

Got it. And the recent Medicare win was a great announcement, not necessarily anticipated by folks. I've been telling you guys all along. You just didn't believe me. You've been setting expectations low, though. But I guess on Medicare, when are you guys going to get the next third and the next third after that? What's, you know, how is that going to progress? Obviously, commercial coverage has been great for some time. Is there anything else we should think about on the coverage front as well?

Todd Edwards, Other

Yeah, I think, as mentioned, commercial coverage, we've had exceptional coverage there with the vast majority of that coverage through a single step through a steroid for the commercial insurance. and a lot of that preferred business. Within Medicaid, one in two patients that are Medicaid beneficiaries have access to Zareve through a single step through a steroid. As mentioned, we've just picked up the Medicare one third of the beneficiaries, so we're very excited about this. We're the only non-steroidal topical now available on Medicare, which is great success. And I lend that to the way we priced Zareve in the market from the beginning. We very strategically priced Zareve so that we could not only pick up commercial coverage, but likewise Medicaid and Medicare so that providers don't have to worry about insurance coverage. We have it whether it's government or commercial. As far as picking up the additional one-third or two-thirds, we have to contract with each PBM repair that's a Part D plan. They typically do that annually, so we're looking forward to picking up some additional Medicare January 1st of 2027 with an option to be able to pull that forward into 2026.

Tyler Van Buren, Analyst — TD Cowan

Great. And I wanted to ask you about competitive landscape. Just latest thoughts on that. Obviously, you guys have done quite well there to date with the launches, but there's also been a recent competitor PD4 approval, so it would be helpful to get your latest understanding there.

Frank Watanabe, CEO

Well, I would, first of all, point to the chart on the right. I think this has really become a marketplace of two products now, and I don't expect that will change. This most recent product that was approved, I'm not losing any sleep over it. It's a very weak PDE4 inhibitor. Reflumol acid is between 25 and 250 times more potent, depending on the PDE4 isoform. And I think we saw with Eucrissa that that potency does matter. It's twice a day, whereas we're once a day. It's an ointment versus we're being a water-based cream. It's only approved in atopic dermatitis. It doesn't have a foam formulation. And this is a company that doesn't have any presence in dermatology, so it's going to be really interesting to see where they find a niche that they can compete. It looks to me like Eucrissa 2.0, and we all know how well Eucrissa did, so we'll just leave it at that yep fair enough so IP what's the latest thoughts on IP yeah you know obviously so you know we built a very strong IP portfolio around Zareev we have 27 US issued US patents now covering various aspects of Zareev we actually picked up a new one last year that extended the patent life on the phone to it for another year so we have patent coverage through 2042 now on the foam 2037 on the cream which hasn't changed um and i think that you know we had nanda filer two years ago uh just about almost exactly two years uh from right now you know that uh their experience i think is indicative of the difficulty of working around our patent portfolio right um it's it's a very extensive set of patents uh which someone we either have to invalidate or design around and if you don't do that then you're probably not a generic and you can't get approved um and uh you know just to update everyone we did have an and a filer they ran an issue with the fda couldn't get approval they asked us to stay the litigation and in return for that stay they're tolling the the 30-month hatch waxman exclusivity so should they restart their program which i'm not convinced that they will uh we will restart our litigation and we have 17 months then to complete that that litigation before they can launch their product and I'm very confident that will prevail in court great profitability you guys are reaching you know profitability obviously can you elaborate on that and cash position cash runway especially as you have lifecycle management and kind of other pipeline opportunities that are emerging how you're thinking about managing that yeah so I you know I think from our standpoint probably more More important than profit is cash flow. We hit cash flow breakeven last quarter. We have said that we will maintain cash flow breakeven on a quarterly basis going forward. And that includes, that guidance includes all of the Zarev Life Cycle Management and the development of 234. We're already getting operating leverage on the business at, you know, I think last year top line grew at twice the rate of the expense base. And we expect that to expand as time goes on. So we have a lot of resources to invest in the business and invest in the pipeline short of us doing some really significant business development, we have infinite cash runway right we're, we put $26 million of cash on the balance sheet last quarter. Profitability we've had profits on q3 and q4 last year we had small profits, you know that may fluctuate from quarter to quarter based on non cash items like. bonus payments or an equity payment, excuse me, expensive equity payments, and milestones. But again, we've made a commitment to manage our cash so that we can stay cash flow positive.

Tyler Van Buren, Analyst — TD Cowan

Do you foresee Arcudis doing some really significant business development?

Frank Watanabe, CEO

If we find something good. I think I've been very consistent. We're always looking. We've been looking since the company started. But I think I've been pretty consistent in making clear I see business development as a nice-to-have, not a must-have, right, given all of the opportunities we have with our existing pipeline and portfolio, but, you know, we have a great development organization, and we have the resources to do things, so if our team finds an asset that we think we can create shareholder value with, absolutely I would do business development. What I won't do is a dumb deal that ends up wasting shareholder money. um what is an asset that could create value that is something good ah let me think it goes from zero to a billion dollars and you know um you know like i think um our our strategy from the outset has been to focus on targets that are have biological validation right to reduce the the ptrs risk um we focus on large markets we're not a rare disease company and we look for differentiated assets, right? I don't think the world needs a bunch of me too products or me less products as in the case of that new topical you mentioned a minute ago. So, you know, if something checked all three of those boxes, we absolutely would be interested in it. And, you know, again, I think given, think about the track record of this company and this team. We have six on-time FDA approvals, four Canadian on-time approvals, no CRLs in the history of the company, nine successful phase threes. There aren't many big companies that can claim that, right? And this is a small but very mighty team that's been able to do this over and over again. So an asset, a good asset, that's maybe in the hands of someone who can't really bring it forward or optimize it is the ideal kind of asset for us because we can take it over and we can make us and them and our shareholders a lot of money in the process.

Tyler Van Buren, Analyst — TD Cowan

That's helpful. Sorry for putting you on the spot there. Maybe we'll refocus. Gotta keep me on my toes. exactly to assets in your hands vitiligo HS obviously very meaningful opportunities that could inflect the commercial franchise so can you elaborate on what you saw in the case reports that makes you all so excited about vitiligo and HS and why you chose those two yeah sure so you know dermatologists the one dermatologists do two things right they write topical steroids and they use drugs off-label that's the it's like a joke that that's That's all dermatologists really do.

Frank Watanabe, CEO

It's maybe an exaggeration, but so they got a hold of Zareev and they just started using it everywhere. And we have case reports or case series now for 43 different diseases that respond to Zareev, at least in clinical practice. Now, you know, you don't know the denominator, you don't know, you know, of these five patients who responded, how many didn't respond, and you don't have a good sense of how quickly they responded either. So that's what we're really looking at in the POC studies. But, you know, with vitiligo, you know, there's a case series that was published last year, five recalcitrant pediatric vitiligo patients all on their face. The patients had all failed topical steroids and they were responding to Zareev. One of those patients that we presented in the slide had failed on the topical JAK inhibitor and responded to Zareev. That starts getting pretty exciting, right? And what we also heard from clinicians is that the response seemed to be pretty quick, which I think has been one of the challenges with vitiligo is how slowly the disease responds to treatment. So we could have a really compelling profile for a lot of patients who have vitiligo. HS, PD-4 has been a well-established mechanism of action in HS, especially oral PD-4 inhibitors. We didn't think that our drug would work because of the depth of inflammation in H.S., but sure enough, George Washington University published a case series in January, I think it was, of three cases with not only a remarkable response, but a very, very rapid response. All three of those patients had responded within four weeks, and I think all three of them had no pain and no itch at the end of four weeks. So that really got us excited about an indication that we had sort of written off. We're now running two small POC studies to look at HS more in detail, a traditional POC study, and then we're looking at gene expression in another study. But, you know, you think about the HS market is, you know, getting very competitive, but they're all biologics, right? No one's developing something for the mild patients who don't qualify for a biologic. And even the biologics, they don't completely get patients clear, right? So if you take someone from a Hurley 3 to Hurley 1, they still have disease, you can use Zareev to clean it up, which is exactly, a lot of the AD people call Zareev the touch-up paint. You put them on a 413, they get a lot better, but they still have some disease. You just get out your touch-up paint and you clean up what's left over. I think that same kind of paradigm could work for us in HS, especially because we don't have any limitation on our use concomitantly with a biologic or another systemic therapy like a jack-in-the-door. that's great and and we'll get both of those phase two uh readouts uh early phase two readouts by early next year so we'll read out uh vitiligo probably in the fourth quarter of this year um and at that point we'll also make a decision about whether we're going to advance into phase three or not and then we expect to see results from the second hs study which is really the key one for us in the first quarter of next year and same thing we would expect to make a decision at that point about whether to advance to phase three or not i would also say we will probably start a couple more POCs this year in other diseases as well. We have a lot of options, right? And it's really just a matter of us prioritizing and picking where to place bets. Perfect.

Tyler Van Buren, Analyst — TD Cowan

And finally, 234, just maybe elaborate on why you guys are excited by that target, why the asset is differentiated. Yeah, sure.

Frank Watanabe, CEO

So 234, what we're doing is we're agonizing an immune checkpoint, right? So the opposite of Keytruda, right? Instead of inhibiting a checkpoint in the immune system, and we're agonizing a checkpoint, the science would suggest that when you agonize these checkpoints, you reset activated immune cells. CD200 is only expressed on an activated immune cells, nowhere else in the body. So we should be able to normalize the immune system without immunosuppressing. What I think got us really excited was that there was another company that was also pursuing this target, and they showed that by drugging this target, you could show improvement and then stop the drug, and the improvement lasted while the patient was off the drug. So essentially, you were putting them into remission. That's what really got us excited about it. We think this could be paradigm changing in autoimmune diseases if it works out. And again, I think particularly with developments with OX40s who just are not living up to their promise, CD200 could be the next big thing in autoimmune disorders. It should be very highly differentiated from the 413s, both in terms of dosing, but also it's a completely different mechanism of action. And so it might work in patients who have inadequate or no response to 413s. We could see a difference in dosing intervals. I think there's a number of opportunities to differentiate. And, you know, it's such a big market. When you look at the psoriasis market, there's 13 biologics in psoriasis market. They're all doing well, right? There's plenty of room in the AD market, which is a bigger market, I think, for additional mechanisms beyond 413.

Tyler Van Buren, Analyst — TD Cowan

Yep. 80 could be a $50 billion market. Could be. So we're up on time. So maybe in closing, we'll ask you both. What aspect of the arcutist story do you believe is most underappreciated by investors?

Frank Watanabe, CEO

I would say I think, I don't think investors have really fully baked in the fact that this is a multi-billion dollar product. You know, we said two and a half to three and a half billion at peak. and I don't think that there's been a lot of work done or attention on the pipeline yet which you know effectively are free options for for our investors yeah the only one I would say is relative to the stairway conversion just continuing to have a greater appreciation for the opportunity that sits there great Frank Todd thank you so much for your time you bet all right thank you good to see