Earnings Labs

Arcutis Biotherapeutics, Inc. (ARQT)

Q3 2022 Earnings Call· Mon, Nov 14, 2022

$23.28

-0.62%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+3.90%

1 Week

-2.73%

1 Month

-11.87%

vs S&P

-8.22%

Transcript

Operator

Operator

Good day, and thank you for standing by. Welcome to the Arcutis Biotherapeutics, Inc. Q3 2022 Earnings Conference Call. [Operator Instructions]. I would now like to hand over the conference to your first speaker today, Eric McIntyre, Head of Investor Relations. Please go ahead.

Eric McIntyre

Analyst

Thank you, Chris. Good afternoon, everyone, and thank you for joining Arcutis' first quarterly earnings call. On today's call, we have Frank Watanabe, President and CEO; Scott Burrows, Chief Financial Officer; Ken Lock, Chief Commercial Officer; and Patrick Burnett, Chief Medical Officer. During this call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. We will then go to Q&A after our prepared remarks. With that, I'll hand the call to Frank.

Todd Watanabe

Analyst

Thanks, Eric. Yes, I'll just add my thanks as well for joining us for our very first earnings call. Today, we're going to be talking about our third quarter performance as well as providing some general updates to you all on our business and the progress that we've made so far this year. So you should have access to the deck on our investor webpage. I'm on Slide 5 to start with. We've been talking all year along about 2022 being a transformational year for Arcutis. We've already delivered on a number of very important catalysts and we've got one very big one coming up just ahead of us. As you look at this slide, I think it's really remarkable, everything that our organization has been able to accomplish just in the last 3 quarters -- and last 3 months, excuse me, last quarter. Obviously, first and foremost, was the launch of ZORYVE 0.3% cream for plaque psoriasis. This is a massive step forward for us in fulfilling our mission of helping patients and bringing meaningful innovation to dermatology. The launch continues to progress really well and momentum is building. And we've got the right team. We're confident we have the right strategy and we certainly know that we've got the right product profile in ZORYVE continue to prove all of that and then to seek out additional reformat indications as we've talked about before, seborrheic dermatitis, atopic dermatitis and scalp psoriasis. And Ken is going to be talking a little bit more about the launch in just a few minutes. I want to take just a minute to talk about the very exciting access wins that we just announced about an hour ago. I think that this is a validation of our responsible pricing strategy and is delivering on…

Kenneth Lock

Analyst

All right. Thanks, Frank, and for following along, we're on Slide 10. So thanks, Frank. And since our approval at the end of July, we've made strong and steady progress in driving the uptake of ZORYVE and really changing the mindset of what a non-steroidal topical agent can do for a psoriasis patient. In particular, a next-generation PDE4 that can break away from the pack and do what others couldn't, powerful efficacy in tough-to-treat areas coupled to an incredible tolerability and safety profile. Firstly, I'd like to note how quickly we were out of the gate with drug and channel post-approval, credit to the teams and manufacturing and commercial operations for making that happen. I've been pleased with our commercial execution and leading indicators of all continuing to point upwards, whether they be talking about awareness, from a physician notation standpoint, intend to prescribe and overall receptivity to our profile. The feedback from the field continues to be incredibly positive, building goodwill with all the patients we've been able to treat to date, and that's the read is delivering on its promise. And lastly, we've seen adoption, not just from topical corticosteroids as anticipated, but also other categories and products, which I'll get into shortly. We've now seen over 4,000 prescriptions of ZORYVE since our mid-August launch with some very healthy double-digit growth over the last 6 weeks since our full field team has been out. We're also making positive strides on the payer front, securing our first major commercial payer win with the formula inclusion on a top PBM plus a large national health plan. This is ultimately the true gating factor in the path towards meaningful growth inflection and growth in improvement and where we can really judge what the longer-term prospects of ZORYVE can be. Lastly, we…

Patrick Burnett

Analyst

Thanks, Ken. I'm on Slide 17, and I'm just going to touch on some accomplishments and upcoming milestones for us. But first, I just want to echo the remarkable list of accomplishments that we have here in the third quarter that Frank mentioned. And I want to give credit to the entire team that was supporting our R&D efforts. And touching on that top milestone, the FDA approval of ZORYVE, Ken has already spoken about the progress of our launch. But I think it's also important to note that dermatologists like myself, we've been waiting for this moment of meaningful innovation in the topical space for decades. And there's really a palpable excitement that only continues to grow as patients and physicians garner experience with ZORYVE. They're being out in the field and being at some of the medical meetings and hearing how this is changing dermatology. I think you can feel a real shift in the field and it's very exciting to be a part of that. So moving on to what we've done in the third quarter. It's been a great quarter for our phone program as well. In the third quarter, we released our top line Phase III ARRECTOR data in September. I'm going to touch a little bit on giving more data out there than what we had just in the press release. In addition for foam, we had the opportunity to present the STRATUM Late-Breaker at the European EADV meeting. STRATUM is our Phase III seb derm study. And did a fantastic job of being able to present this for us and got a really nice response and some great awareness for our data in seborrheic dermatitis for the foam product. Moving on to cream. As you know, we've completed enrollment in the INTEGUMENT-1 and…

Scott Burrows

Analyst

Thanks, Patrick. We had a couple of very important and exciting financial milestones in the third quarter. First, with the ZORYVE launch in August, the quarter represents our first as a revenue-generating company. And second, we were able to bolster our financial strength in the quarter by raising an additional $285 million on the back of the psoriasis approval leaving us very well-positioned to continue investing in support of both the ZORYVE launch and the continued progress of our pipeline. Turning to the financial results for Q3 on Page 28 of the slide deck. Net product revenues were $725,000 for the quarter. The revenues were driven roughly equally from end customer demand in the quarter as well as the expected initial wholesaler inventory build. Our gross to net discount rate in the quarter was high as expected, given we are still working to secure payer reimbursement, but our discount rate was materially better than other recent branded topical launches given our differentiated pricing and access strategy. We expect modest improvement in the gross to net discount rate in the fourth quarter given the timing of our recently announced formulary coverage with continued progress on delivering more value per script expected throughout 2023. We also expect continued demand growth as the launch accelerates and more formulary coverage is added for ZORYVE. Cost of sales was approximately $270,000 in the quarter. We paid a $7.5 million milestone payment to in the quarter related to the FDA approval of ZORYVE. This payment was capitalized and will be amortized straight line over 10 years to the cost of sales P&L line. So that amortization charge for Q3 has an overweighted impact on our cost of sales percentage in the quarter given the modest revenues. We continue to expect our cost of sales margin to…

Todd Watanabe

Analyst

Okay, Scott. So thank you for listening to the prepared comments, and I think we're going to now transition to a Q&A system. Back over to you, Eric.

Eric McIntyre

Analyst

Yes. Chris, can you open lines for questions?

Operator

Operator

[Operator Instructions]. Our first question comes from the line of Ken Cacciatore from Cowen.

Kenneth Cacciatore

Analyst

Real exciting time. I know big major data coming up. But I wanted to focus on the ZORYVE launch and some of Ken's comments. You really are taking a different approach here versus your competitor. And Ken hit on some points -- actually, I wrote one of them down, which was in just saying we're doing it without accelerants, which is a new term, but I think very descriptive. But maybe you guys could take some time and Ken review a little bit of why it's so important you're taking the strategy that you're taking, why you are not being a bit more aggressive on sampling and buy-downs? And what does that mean in terms of your preservation of long-term value? And I guess a corollary to that is, as you approach the strategy, you talk about these nice contract wins. Can you try to contextualize -- is it the value that you thought in these first contracts? So is it validation early on that strategy? So just wanted to hear a fuller articulation of your choices versus theirs?

Kenneth Lock

Analyst

Sure, Ken. Great question. So I'll try to break them apart, starting with the accelerant. So I think there are many ways to fuel Rx growth obviously, organic demand built on the backs of their clinical profile. But there are many things that one can do to enhance your shift trends. And we've seen that with other products out there where they better buy down opportunities, very, very long the packets, cash offers, things that have -- don't really represent, I think, sort of the long-term sustainable type of demand that you won in the sense that at some point in time, that will have a material impact to your gross finance. And we've seen kind of learning from the past, we've seen some companies that have gotten deep and tolls and sort of ultimately cease to exist as an organization based on their inability to claw their way out of these scenarios. So that was kind of the approach we're taking. It is very different. And I think, obviously, it remains to be seen. But we're very confident in the sense that even without generating kind of this massive uptake at the beginning and sort of the value proposition of our clinical profile was very clear. And the decision to cover us, both at the PBM and planned level, they could see our proposition, our value, our clinical profile and the approach we were taking and sort of I think we were rewarded for that. So we did not necessarily have to take the traditional generate volume in all costs and then rebate massively off of a very high price to try to secure access. So it is a different playbook. We're very happy that we're able to report today the output of that. But it really just must…

Kenneth Cacciatore

Analyst

It did. You did. It was very comprehensive, and congrats on the progress.

Operator

Operator

The next question comes from the line of Seamus Fernandez from Guggenheim Securities.

Seamus Fernandez

Analyst

So just two quick questions. Just from an expectation perspective, wanted to just get a sense of as it relates to the data that have been presented so far in AD and the data that were presented in your presentation of the FDA's endpoint. Just wanted to clarify as we speak with investors, some are kind of looking at the difference of 1 or 2 point change rather than the 1 or 2-point changed with the 2-point differential as the primary endpoint. And just wanted to make sure that that was clarified for investors in terms of what you guys saw in your Phase II results and maybe even provide the slide to refer back to from your 2020 presentation. Just because I think it's important that people have the sort of right metrics in place. Separately, just also wanted to get a sense of what you guys actually think the AD data means for your potential to perhaps more aggressively promote ZORYVE cream heading into the potential approval of that product. Would you change anything related to your promotional strategy at all with regard to couponing and getting more aggressive with the experience that physicians are gaining with ZORYVE? Are you happy with the experience that they're gaining in psoriasis and just looking forward to the new indication? And then just the last question was really, congrats on the early formulary win here. Can you just clarify, is the competitor product TAMA also on formulary? Or are you guys exclusively the product as the formulary win there? And do you see additional formulary wins in the relative near term that could surprise to the upside?

Todd Watanabe

Analyst

There's a lot of questions, Seamus. Okay. We're going to turn it over to -- we'll turn it over to Patrick to address your first question about the INTEGUMENT.

Patrick Burnett

Analyst

Yes, Seamus. Happy to kind of make it very clear what the endpoints are there. So the primary endpoint for INTEGUMENT-1, INTEGUMENT-2, and INTEGUMENT-PED is IGA success. And so when we're enrolling mild and moderate patients, those patients need to have a 2-point improvement and get to clear or almost clear. So clear, almost clear means is 0 or 1, mild and moderate on the IGA is 2-3 and severe, which we're not enrolling into these trials, would be 4. So that means that a patient who comes in at a mild needs to get to clear in order to meet that IGA success criteria. The other endpoint that you had mentioned, which does appear in much more communication around this trial because it really is the easiest one to communicate to patients because there's 2-step improvement and to doctors. The 2-step improvement involved in the IGA success can sometimes be a little bit trickier people to get their heads around. Whereas when you're talking to a patient or a physician, you say, listen, we're going to get this patient to clear or almost clear. They know what that means. Clear means they don't have any disease and almost clear means they have very little and processible disease that's remaining on them. So just kind of coming back to our data, we showed about 50% of patients between the 0.05 and the 0.15 in our Phase II study, getting to clear or almost clear and around a 30% vehicle rate on that endpoint. For IGA success, 0.05 and 0.15 were both around 37% to 38%. And so the vehicle also there demonstrated 22% for IGA success. So it was that 15% difference between -- on the IGA success that we use to power our Phase III studies because our expectation INTEGUMENT-1, INTEGUMENT-2 is that we'll be able to demonstrate similar efficacy to what we've shown previously. And just to confirm, our expectation is not to somehow reduce that vehicle rate. We think that's an important intrinsic part of our product. So with that, I'll turn it over to Ken to address the latter part of your question.

Kenneth Lock

Analyst

Yes. So Seamus, good to talk to you. So I'm going to try to tackle the question regarding kind of more aggressive promotion with respect to atopic dermatitis. So clearly, we're a learning organization and I think many things are up for grabs. One thing I'd point you to, though, is obviously the temporal nature of our launch is AD is a little bit farther out and we'd have to sort of understand the landscape with respect to coverage. As you know, with add-on indications, sometimes you're able to kind of leverage the decisions made on earlier products in the portfolio. And if that were the case, you could certainly imagine a different approach, owing to the fact that we have several quarters under our belt with the sensor earnings and be in a different position to maintain kind of sustainability. So I think the shorter answer is, it depends and I think we would reserve the right to kind of dial up and dial down the level of sort of the tactics and approaches we could take. And certainly, I think the competitive intensity would have something to do with that as well. So I can't tell you that we will [indiscernible] other than to say all eyes -- all things are on the table. But clearly, the access picture and kind of where we are as an organization given the downstream launches would play a role in terms of how "aggressively" we would play that. Now with respect to the formulary, I only speak to us. I think we're still working with our partners to sort of get to the point where we'll fully disclose the details. But I will say that once that comes out, you will have a better picture of kind of the situation we're in. That look for those details soon, but right now we're not at the point where we can sort of fully disclose the position only that we are covered on the PBN and the national level.

Operator

Operator

Our next question comes from the line of Vikram Purohit from Morgan Stanley.

Vikram Purohit

Analyst

So from our side, both on the ZORYVE launch. So first, on inventory, what's the typical steady state of inventory you'd expect to have maintained for ZORYVE in the coming quarters? And then secondly, at this point of the launch, do you feel like you've seen enough kind of patient experiences at this point to understand how many tubes per year might be reasonable for people on ZORYVE to kind of work through on an annual basis?

Scott Burrows

Analyst

Sure. Vikram, it's Scott. Good to hear from you. On your question around the wholesale inventory piece, it was certainly noticeable, I think I mentioned in my prepared comments, about half of the sales in the quarter related to the build. I think I would just say that we don't expect it to be a meaningfully -- a meaningful contributor. We expect the pickup in demand-driven strips to be the main portion of sales going forward. Now you've probably seen from other companies, wholesale inventories do fluctuate. It's just hard to predict these things. And so we'll be sure to call out when wholesaler inventory impacts the sales in the quarter. But again, the proportion we saw in Q3 was driven by the initial build-out launch. I'll hand it off to Ken to talk about your second question.

Kenneth Lock

Analyst

Yes. So refill rates, still very early in launch. And so I don't know that we have any confirmatory or data that suggests that we would back off of our earlier comments regarding the 3 to 4 tubes. I think it's very early days. The vast majority of patients have really only received their first tube. And so in many cases, depending on the body surface area that too can last 2 to 3 months. So it will take some time. What's encouraging is that we aren't seeing refills. And again, that's always confirmatory feedback that the patients have a lot of experience. They're seeing the efficacy they're looking for. And really, those are good signs, but -- and we feel good about our tube guidance at the moment. So probably far too early to change that assumption.

Operator

Operator

Our next question comes from the line of Louise Chen from Cantor.

Louise Chen

Analyst

Congratulations to all success this quarter. I had a few questions for you. So first one I had for you was that I know there has been a lot of focus on the initial launch prescriptions and it's probably too early to draw any conclusions here on peak sales potential. But when do you think you'll actually hit your stride here? And then second question I had for you is physician feedback on ZORYVE. Why do people like it? Why are they prescribing it? What drugs are they switching from? And then last question I had was just on AD. The INTEGUMENT-1 and 2, are you filing with that data? Or are you going to wait for PED?

Kenneth Lock

Analyst

Sure. Hey, Louise, it's Ken. So I think what we said earlier was we think that the momentum that we have, coupled with the payer access coming into play will really help be that inflection point. I don't know exactly -- I don't know if you're asking me when hitting stride, what stride means, meaning like peak. But I think that we're hitting on also is at this point. And clearly there's a few more -- there's still more work to do with respect to the payers. So today is a great marker for us, but we've got many more wins to sort of fully unlock the potential. And really, we really think that the reduction in prescriber burden is really one of the biggest keys to the success and widespread adoption of our products. So until that work is done, it was hard for me to say we sort of like hit on all cylinders that we're running at full speed quite yet on that. So I think that's really the marker that you should then look to sort of see if we're executing fully. With respect to the feedback on the drug, I mean, I think I mentioned earlier, there's been a lot of positive feedback. We've been out in the field quite a bit, listening, learning. And I think earlier in my slide deck I talked about the products from which people are switching from. So I think on Slide 12 in the deck, you can see there's a whole host of products in there. Again, the majority of which is what we would assume, topical corticosteroid that sort of the goal, I think all the products that newer topical products are sort of gunning for that same topical corticosteroid market. But you are also seeing some of the both newer branded products as well as some of the alternative steroids like vitamin D and calcineurin inhibitors being displaced as well. So there's a pretty healthy mix. There's no one thing. Again, the overwhelming modality from which people are coming from is topical -- are topical steroids. Patrick, anything else to add in terms of the feedback or what else you'd be thinking about using?

Patrick Burnett

Analyst

Yes. I mean the only thing is I would say, just from our kind of discussions with dermatologists and other health care providers right now is it -- we're hearing it not from like a single type of patients. So it's not really -- we're not seeing it being niched as like the intertriginous drug or something like that. We're hearing broadly patients who are being planned to be put over on to a biologic. They're putting some patients on to this, on to ZORYVE. We're hearing a lot of patients switching over from topical corticosteroids. And so I think that the breadth of where those patients are coming from is really supportive of the clinical profile that we saw. It is strong enough to work on knees and elbows, but it also is able to be used on some of the more sensitive areas like the face and intertriginous. And that's something that is very differentiating, especially to the topical steroids for the vast majority of patients out there. Yes, Louise, I'll take the third one as well, which is about our AD submission plan. So we're planning on reading out the INTEGUMENT-1, INTEGUMENT-2 studies, as mentioned, those will come before the end of this year. Our plan is to make a supplemental NDA to the cream for ages 6 and above, which will include just the data of those ages. So we will not be including the INTEGUMENT-PEDs trial. That's at a different dose of 0.05 and ages 2 to 5-year olds. So we would move through the submission and approval for ages 6 and above. And then after gaining that initial approval, then we would come back with another supplemental that would take the data from ages 2 to 5 and extend the label into that lower age group. That's our plan right now.

Operator

Operator

Our next question comes from the line of Chris Shibutani from Goldman Sachs.

Unidentified Analyst

Analyst

This is on for Chris. We have one on ZORYVE and then one of the upcoming Atopic Derm data. On ZORYVE with the recent formulary and PBM wins, can you speak to the percent of covered lives on a national basis? And then for the INTEGUMENT studies, the Phase III studies are recruiting a slightly younger age than was studied in the Phase II. Can you just remind us what went into that decision and how you expect that to affect the ultimate outcome?

Kenneth Lock

Analyst

Steven, this is Ken. So we won't be speaking to covered lives today. Look for a future announcement on that front with all the details once we work through with our partner. So that's not something we're announcing at this moment, but hang tight on that one. Patrick?

Patrick Burnett

Analyst

Yes. So with regard to atopic dermatitis, the difference in the ages. In our Phase II study, we studied down to ages 12 and above. This submission for INTEGUMENT-1 and INTEGUMENT-2 and the upcoming data readout will be ages 6 and above. So we don't really see this as a significant risk to the program. When we've looked over other data from both PDE4 inhibition in atopic dermatitis, topical treatments as well as systemic treatments, we're not really seeing how patients across these different age groups are responding differentially to therapies. And in particular, AD treatment with PDE4, there's a lot of history there that really gives us support that we anticipate the similar kind of effect even going down into those younger age groups. So we're very confident about the consistency of our results and especially with this next readout, we're only extending the age from 12 and above down to 6 and above.

Operator

Operator

Our next question comes from the line of Uy Ear from Mizuho Group.

Uy Ear

Analyst

So I guess my first question is, I think you previously mentioned that depending on how quickly you can analyze the data, you're not committed to reading out INTEGUMENT-1 and 2 at the same time. Just wondering if this is still true. And I guess my second question is, could you sort of help us understand why you wouldn't decide not to submit, I guess, the ARRECTOR data and the STRATUM data for the foam formulation at the same time? Is it primarily just because of the speed and analysis? Or is it something else? Because it seems that waiting a couple of months, it's probably better than maybe 10 months or more, I guess. And my third question is, given everything that we know today, particularly with respect to the formulary win, could you sort of help us understand a little bit what you think the gross to net could be next year?

Kenneth Lock

Analyst

So Patrick, do you want to maybe take the first 2 and then Scott, you can address the GTM. Thanks for the question, Uy.

Patrick Burnett

Analyst

Yes, this is Patrick. So yes, as you know, we ended recruitment in INTEGUMENT-1, INTEGUMENT-2 about 3 weeks off from each other in August. And so our expectation is that that differential in the readout will continue through kind of the final data to top line. And so our plan is not to hold the 2 studies to be read out together unless something were to happen, which would cause them to be closer than the current 3-week separation that they had coming into -- through the recruitment. So that's our plan right now is that if that continues, that we would read one out and then read the second one out separately. With regard to the timing of ARRECTOR and STRATUM and kind of foam submission. Our feeling, given the differential in the time between when we read out the seb derm data and scalp psoriasis, especially with seborrheic dermatitis being an indication where there really hadn't been any development going on and patients are very much waiting for this treatment, we hear that when we talk to investigators, we hear that when we talk to patients who were in the trial. We felt that holding that at all really wasn't best for patients and really wasn't best for us as a company as well. So we're going to move straightforward with getting the seb derm submission in. And then as quickly as possible on the heels of an approval there that we would file a supplemental for the scalp psoriasis.

Todd Watanabe

Analyst

Yes. I would just -- maybe I would add, I think Wall Street still does not appreciate just how big an opportunity seborrheic dermatitis is. I think the level of excitement in the dermatology community about the foam in seborrheic dermatitis is probably the highest of any of our indications. This is a disease that has been almost entirely neglected for 40 years. Patrick and Ken and I were out in the field last week and we heard consistently that dermatologists are seeing more seb derm patients than psoriasis patients every day. They are pun intended foaming at the mouth for the foam for seborrheic dermatitis. And so as Patrick said, we didn't think it was right for patients or for the company to hold that submission by a single day. We want to get it out as quickly as possible so that we can start helping dermatologists treat their seb derm patients. And I think Wall Street will start to realize just how big an opportunity this is for us for 154 in seb derm.

Kenneth Lock

Analyst

Scott, do you want to…

Scott Burrows

Analyst

Yes. Thanks a lot for the question. So looking at Q3, if you triangulate between the commentary that we made on the inventory build and then the demand -- the script demand data that you see week to week, I think you would come to a gross net range in the quarter of about 70% to 80%. So that's for Q3. When we look ahead to Q4, very exciting announcements we made today around the formulary coverage. I would say that given the time kind of within the quarter that it occurred, the improvement in gross to net for Q4, the expectation there should be relatively modest. But then when we get into 2023, I think we're on a good path. We expect additional formulary coverage to take hold over time. And so that would put us on the path to -- I think what we've talked about in the past is, call it, 40%, 50% long-term gross to net discount rate. And that, hopefully, I think we've given a base case of maybe 12 to 18 months from launch. Obviously we're doing everything we can to accelerate it. And the announcement we made today is a good down payment on that.

Operator

Operator

Our next question comes from the line of Greg Fraser from Truist.

Gregory Fraser

Analyst

I wanted to ask about the feedback. Curious, specifically for feedback that you've been hearing from docs that have been prescribing the other new drug in the class B TAMA. And on the switching, what are the reasons that you've heard for docs switching patients from the TAMA? Are the switches happening for efficacy reasons or more about side effects? Any color there would be helpful.

Todd Watanabe

Analyst

Yes. So I would just say we don't have any direct feedback from doctors on why they might switch from 1 drug to another drug. The switching data we're getting through secondary sources, yes, I don't know that there's a whole lot more we can say about that at this point in the game.

Gregory Fraser

Analyst

What about feedback from docs?

Todd Watanabe

Analyst

Well, I mean, in terms of feedback, I think what we've heard very consistently is that they're impressed with the rapidity of ZORYVE's effect and the efficacy that they're seeing on -- particularly on tough to treat plaques. And then the thing that we really never hear about is any tolerability issues with ZORYVE. And I think that that is a significant difference from really every other topical on the market. Every single topical product they have other than ZORYVE is associated with fairly significant local tolerability issues, whether that's steroids or TCIs or vitamin D or vitamin A or any of the other products. And so I think doctors have been very pleasantly surprised at how well patients tolerate ZORYVE and that's been something that's come up very consistently in our discussions with users.

Operator

Operator

Our next question comes from the line of Serge Belanger from Needham.

Serge Belanger

Analyst

A couple of quick questions. I guess for Ken on the coverage of ZORYVE. I know it's only been a couple of months since the approval and the launch. But curious if your initial assumptions of being at steady state coverage and gross to nets of 40% to 50% within 12 to 18 months are still intact? And then secondly, since ZORYVE is launching and competing directly with another topical product for the same indications, should we expect to see some exclusive formulary wins for either ZORYVE or the other products?

Kenneth Lock

Analyst

Sure. So start with the first question. So I think Scott said earlier, we do expect within the time frame that we've talked about before 12 to 18 months that we would achieve that sort of steady-state growth that industry-wide, the benchmark is about 50%, which would represent great performance, frankly. And so we're on the way to that path in terms of achieving that. So I think the timing has been excellent in this case. I can't really talk about when those [indiscernible] will come. But certainly, I think it's validating the [indiscernible] trying to accelerate that. It would be perhaps atypical for a product to come out and receive that kind of coverage that quickly. So we are pleased, but it's certainly -- I don't know that you can sort of read that through that sort of the next one and the next one quite yet. So I'd say 12 to 18 months is very reasonable. With respect to kind of exclusivity in general, I think payers are typically loath to give exclusive contracts or try to lock out on other products early in the lifecycle. You tend to see that a little bit more in more mature markets or when there's sort of a clear incentive to do so. So early on, I think payers are watching kind of the volume uptake, the way in which that volume is generated. And also, I'm kind of looking for those dynamics. And then ultimately may cost that out. And we've seen this in other competitive markets in derm, biologics space, in particular, we see a lot of the activity, but it's often not quite at the beginning. And so again, they also don't necessarily want to pick the wrong horse, so to speak. So you typically don't see that. And I think generally, companies aren't looking to sort of bid for the access either very early in the launch. So I would not expect to see that emerge too quickly.

Operator

Operator

I would now like to turn it back to Frank Watanabe, CEO, for closing remarks.

Todd Watanabe

Analyst

Okay. Well, I know we're a little over time, so I'll keep it brief. I just want to thank everyone who joined us on the call today. Thanks to all the people who had some very probing questions for us. And I also wanted to take just a moment to thank the Arcutis staff and we started off by talking about everything that we've accomplished in 2022 and in Q3 and we would not have been able to accomplish any of that without the brilliance and hard work of the entire Arcutis team. Patrick and Ken and I just -- we're the front men, but it's the folks in the trenches who are doing all the work. And so I want to thank all of them for their hard work and their contributions in realizing our mission and bringing these therapies to patients. So thanks a lot for joining us and we look forward to talking to you all again next quarter.

Operator

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.