Good morning, everybody, and welcome to day two of Guggenheim's sixth annual Biotech Conference. I'm Seamus Fernandez, one of Guggenheim's senior analysts here. And I am really pleased to be joined by Revance Therapeutics CEO Mark Foley, to my left. Thanks, Mark, for joining us. Thanks for having me. So, you know, Mark, I think a lot of people are relatively familiar with the Revance story, but maybe you could just kind of give us a quick rundown of how kind of 2023 shook out for your aesthetics portfolio and the launches, and then, you know, what we're looking forward to in 2024. Sure, happy to do that. I think before I kind of talk about 2023, maybe put a little bit in the context too. So we, we licensed the RHA filler line from Teoxane, launched that beginning in 2020, in the middle of the pandemic. We just completed our third year of launch, and I would say that, you know, I'm really proud of the team and the work that they've done over the last three years. We exited December on about a 10% share, and so I think the team's done a great job of driving, you know, deeper penetration with the fillers in a market where we didn't have a toxin. And so I think that that execution went really well, and we grew at about 20% this year. And then on the toxin side, we just finished our first full year of launch, and again, I think it was a great year in terms of revenue performance. If you look at the consensus numbers back in November of 2022, after we were approved, consensus was sitting around $68 million, and we did $84 million in 2023 on the toxin side of it. And if you look at the first five quarters of launch, our first five quarters of launch compared to the last three competitors that have entered, Jeuveau, Xeomin, and Dysport, we sold more in our first five quarters than all other three combined. So I know there's a lot of focus, appropriately so, on the repricing strategy and the change, which all makes sense, but I, I actually think that 2023 was a really good year for us in terms of overall revenue delivery. Obviously, going forward, now there's a little bit of a reset in terms of expectations on the go-forward side of it. And when we came into the market, we had very robust glabellar lines data, some phase two data in upper facial lines, and a lot of market research that informed our, our strategy, which was based on a, a premium price in the marketplace. We also though set up the PrevU program, which was designed to say: How do we get real-world experience with a smaller subgroup of customers to make sure that we can use that to inform future decisions? I think what we heard loud and clear from the market when we got out there was, with a premium price, product expectations start to become elevated, and in a market where all toxins have some level of variability, if a premium product doesn't meet sort of that expectation, the switch becomes so much harder. Yeah. So we adjusted the price to be in line with other toxins. That has been very well received. In Q4, we saw the desired impact of that price change, where units were up on a 22% basis on a quarter-over-quarter, despite with still a very targeted focus of doubling back to those accounts versus trying to necessarily just go open up new accounts. And we also heard that, "Hey, we could be easier to do business with." And so we've made some changes in terms of engagement with KOLs, meeting support, some of those other things as well. So we actually feel like based on that feedback and the changes that we've made, you know, the... I think the revenue demonstrates there's a lot of interest in DAXXIFY. I think people see it as a differentiated product with really good performance characteristics and demand and interest from consumers. And now with this price change, we believe that we're making all the right changes to be able to really drive the type of penetration that we want to. So, you know, 2023 was bumpy in terms of the need to do the price and the strategy reset, but we actually come into 2024 with early validation of the change in strategy, and I think growing confidence in the provider community that with this change, that, you know, we can take meaningful share in the market. Got it. Can you talk a little bit about, you know, obviously we're now another month into the first quarter. I know first quarter kind of tends to be a little bit slower. Right. I don't know, I was just out at a couple of malls with my daughter and it doesn't look like there's a big slowdown in the economy. Right. - as far as I can tell. Right. You know, maybe you can just give us a sense of how things are tracking, at least from your perspective, in the first quarter. Yeah. So, you know, in terms of what's incremental from when we pre-announced, I would just say that we're very pleased with sort of how things are tracking relative to our internal expectations. As you mentioned, Q1 is a seasonally down quarter, partly because of procedures and partly because all of us in the aesthetic industry tend to have programs and other incentives that encourages buying at the end of the quarter. So some of it's a little bit of a stocking issue, where people buy a lot at the end to make numbers and other things, and then it's a little slower in the beginning. And to put in perspective, the last two years, our Q4 to Q1 change in the RHA filler line, which was more mature for us, was down 13%, yet we grew 50% two years ago, and we grew 20% last year, despite a down 13% quarter. Competitor toxins also see a down in Q4 to Q1. So we've tried to be clear. We would expect similar seasonality, more so on the filler side, which is a more mature brand. And then on the toxin side, we expect to see some seasonality, but given how early we are in the launch, we think that will be more muted. And in terms of kind of what we're seeing thus far, we do think that, you know, there's really good demand. And I think what's gonna impact us, you know, more around kind of what we're seeing in January, is just about our ability to execute. We did say that when we made the price change, that we expect it's probably about two quarters, where the focus in the first two quarters is doubling back to those existing accounts. Mm-hmm. 'Cause our belief that to create long-term, you know, stable growth, is that we need to have some of these anchor customers, who are, in most cases, RHA customers. We have good relationships with them. If they had a mixed experience, we think it's worth that extra time at the front end to go back and try and resolve what those issues are, as to get them going, versus just moving on and trying. And so we think, you know, Q1 will also be very focused, and then as we get into Q2, we'll kind of focus a little bit more on a traditional launch trajectory. Got it. And, you know, one of the things that I think had originally been sort of a call point and has shifted with the price strategy has been to focus exclusively on dermatologists. You know, how or what do you see as the opportunity to kind of expand the pool of accounts going forward, you know, as you sort of look at the revised price strategy? Yeah, you know, originally, and so we've long said that we believe there's around 40,000 aesthetic accounts in the U.S., and what we called sort of our prestige strategy was targeted at kind of this premium segment, which we said was about a third of the market, doing a little more than half of the procedures. I think now with our adjustment in the pricing to be more in line with other toxins, but deliver the value, we actually think all those 40,000 now come into play. Having said that, we think that there's just like with our filler, right? We were averaging on average 500 new accounts per quarter because that process of educating somebody, training them, going in and sampling them, doing a day where, you know, we're helping support the practice, is still fundamental to our strategy of bringing new and innovative products in there. But we do think that we will play in a much bigger part of the market now because of the change in strategy. Got it. Okay. Maybe we can just kind of talk about where, you know, your experience of the macro market. You know, when we run surveys of physicians, there's still some anxiety over, you know, how the macro environment's playing out. Just interested to know, you know, where you feel DAXXIFY is specifically gonna fit, you know, just maybe given some uncertainty with physicians, even though, you know, again, I don't-- I can't say that I personally see it. Yeah. Yeah, listen, I, I think that we saw what was a really healthy response coming out of the pandemic, where people were spending a lot of time on Zoom. They had a lot of discretionary income, and so I think we saw a little bit of an acceleration in the adoption, and then things, things sort of plateaued and settled back down. I think last year, if we look at some of the independent market research that we have access to, the filler market was a tough market last year for a lot of the major competitors. We had a great year in terms of growing, taking share. It does feel like that's starting to now get back to a normal trend, where we should see good, steady growth. I think the toxin market has proven to be more resilient. Yeah. Again, as we come in, I think, you know, the market seems to be in a good spot. I would argue that our ability to deliver revenue is gonna be less dependent on the economy and much more on our ability to execute. Because I think there's a compelling value proposition, even in a market that maybe is a little bit, you know, weak from an economic perspective, 'cause I think they can argue, "I'm gonna give you a product that's gonna cost you similar amount of money, yet has these performance attributes," and I almost think there's a better value story in that environment. When you say performance attributes, just trying to get a better understanding of how you are communicating that to physicians. What is it about this product? So, you know, as an example, you know, we know Evolus has done a great job kind of marketing Jeuveau to the millennials- Right. and we know that that is sort of a has been a really strong target market- Right ... for them. Right. Where do you feel DAXXIFY is kind of carving out its niche or, you know, broader than that? Yeah, so listen, every competitor kind of tries to figure out what they can offer in the market that's gonna separate them, whether it's price, segment of the market, or performance of the product. And I think we, we like where we're positioned in terms of the performance attributes of the product, where we're seeing it, it's long lasting, kicks in quickly, and really good skin quality. Yeah. And so we've intentionally focused more on the provider than on the consumer, 'cause we don't think that there's necessarily a subset where we have to just limit or focus on. We think that in talking to the providers, you know, there's a wide range of their consumers that can benefit from that. And so I think the, the value prop is, "Hey, I've got this new peptide-enhanced technology. It's the only one on the market. It's long lasting, kicks in quickly, better skin quality. It's not gonna cost you any more money. Do you want to give it a try?" And then as consumers get experience with that and feel like they're gonna get more value for the same dollar. So that's kind of our play, is more that we're adding, you know, something new, better product, and that's kind of our positioning. Got it. When we think about just sort of the account expansion- Mm-hmm ... and then sort of the... You know, it seems like you're starting to kind of report, account expansion and retention. Correct. And so how do you sort of see that evolving going forward? I think the account expansion and retention had maybe, you know— Do you see that, that gap narrowing materially as, as we move through the year? Well, I think it's gonna look a lot like the RHA launch- Okay ... which would be the desired, where you, you're constantly onboarding new accounts, but figuring out ways to continue to go deeper with existing accounts. Again, we spent a lot of time doubling back on the accounts that we had onboarded for the reasons I mentioned earlier. And so, yeah, we've got 7,000 accounts that we have a relationship with. We've sold DAXXIFY into 3,000. We've doubled back and spent a lot more time with those 3,000.... but we obviously now have this group of additional 4,000 accounts that we have a relationship with, that we can bring DAXXIFY to. And there's gonna be accounts that were outside of that 7,000 too, that for whatever reason, sort of felt like maybe RHA wasn't the right fit for them at that time, but now DAXXIFY might be that entrée in there. So that is part of the hope, that those accounts that maybe are RHA customers that were a little uncertain about whether or not they wanted to bring DAXXIFY in, we can now, with the pricing strategy change, reopen those discussions. Or we certainly had a number of accounts that, for whatever reason, weren't ready to engage with RHA, but are intrigued by DAXXIFY, which could be a way to start with DAXXIFY and then bring RHA in. Got it. Okay. And in terms of, you know, just the guidance for where we sort of started this year, total revenue guidance was, you know, at least $280 million- Right ... in 2024. You know, that may have been, you know, a minor reset for consensus- Right ... not a major dynamic there. But can you talk a little bit about how you sort of see the mix of DAXXIFY versus filler? And, you know, what are kind of the pushes and pulls around, you know, potentially seeing numbers, you know, beyond that, that kind of minimum threshold? Yeah. Well, I think that since we hadn't guided before and knew that we were, you know, at times trying to live up to a consensus number that was, you know, being put together in the absence of input from us, we thought it was really important with the reset that we showed conviction and confidence in what we believed we could deliver on the low end of things. Yeah. So we put that out there. We believe that, you know, we'll continue to see growth in the RHA filler line. And we expect that RHA will be more than half of the revenue. But, you know, we also expect, given where we are on the DAXXIFY launch, that we'll see, you know, good, healthy growth there also. And so it just comes down to, like I said before, the, you know, first quarter is still focused on that doubling back, more time with those existing, and then moving into more of a traditional launch cadence as we move into Q2. And again, it's early, we're only in January, but we feel good how we're tracking. Got it. Great. So let's talk a little bit about therapeutics. Right. You know, you've got your FDA approval in hand for cervical dystonia. Just, you know, remind us again, kind of the launch strategy and, you know, what you see as the contribution this year, and, you know, what are kind of the key sort of steps along the way to really executing on this opportunity? Yeah. Well, similar to the aesthetics launch, we launched with a PrevU program with the same idea, that we've got really good clinical data, but we know that in the real world, it's gonna get used in a little different way, and so we want to make sure that we give that opportunity for some of these leading clinicians to use the product and give feedback that will help further inform the launch. Also, I think what's really interesting is, I do think that the therapeutic experience is also gonna have an additional sort of benefit to aesthetics, because as people understand sort of that dose-response curve, that will continue to, I think, shed more light on kind of how it gets used ultimately in aesthetics. So we kicked off the PrevU program. We recently announced the receipt of a J-code. We already have over 100 commercial lives covered. Mm-hmm. And many of these commercial carriers will sort of treat toxins generically, and so, you know, we'll be interested to see sort of how that translates in sort of the usage at these, you know, within these different payer environments. To date, we're probably in about 30 accounts. We started PrevU with a little less than 20, and we've added some additional accounts. We've been very encouraged in terms of the feedback that we have had. And what's really interesting in the therapeutic side of it is, over 80% of patients that have cervical dystonia see symptom breakthrough before they can get re-injected. Right. All toxins have a black box, meaning they can't get re-injected until week 12. So for those patients, it's less about do they get 16 weeks, 20 weeks, 24 weeks? The first thing is, do I get better symptom control within the treatment course? And if so, that's a big win for them. We're seeing them, you know, use the product as expected, which this is mainly a switch patient. It's not like there's a whole lot of new CD patients coming in. And what they'll tend to do is start with a lower dose to make sure they don't see any safety issues, and then they'll start to bump up the dose, which is why we wanted to have a PrevU program that ran through middle of this year, to allow them to go through a few treatment cycles. We're seeing really good safety profile, and the safety profile in our trial showed low single-digit dysphagia and muscle weakness rates, which is much better than published literature with a lot of the others, so that's a really encouraging sign. We're seeing them increase dose without issue, and continuing to see the benefit of that on the therapeutic outcome side. In the early experiences that we're seeing really good resolution of symptoms within that window. And so we're very excited and think that DAXXIFY could play a big role in therapeutics. Just remind us again, you know, sort of the price strategy in that market and how it compares to, I guess, it's really mostly Botox. Yeah. Yeah, so, because it's the same BLA for both the aesthetic and the therapeutic product, our pricing is going to be impacted based on what our, ultimately, our ASP is in aesthetics since we launched there. So pricing is gonna be consistent across both. What's interesting, if you look at then our price and our clinical data for cervical dystonia, unlike aesthetics, where we did 2-to-1 dosing, so 40 units in the glabella versus, let's say, 20 units of DAXXIFY, same amount of toxin, but different units. In our cervical dystonia program, we were actually seeing the duration benefit on 1-to-1 dosing. Hmm. So for payers and for patients that have a copay, we are seeing that our vial price now is gonna be roughly half of what, you know, perhaps a Botox patient might- Right ... cost them. And so that's, that's caught the eye, certainly of the payers. Right. Now, we'll see where they end up on the dosing side of it, but we're seeing... which again, speaks to the power of the peptide. I think it's just a much more efficient way to get toxin to where it wants to go. Got it. Okay. It would just seem like that once the experience is firmly established, there would be a pretty rapid switch opportunity that would perhaps even be driven by the payers. What, you know, how concentrated are the access points, you know, from a physician perspective? Yeah. So, you know, the top 600 injectors do about 70% of the volume, so it is a very concentrated base. But I would say that I don't know that the payers, at this early stage, until there's a lot of claims data, are going to aggressively push. I think what they will do is, with the interaction we've had with the commercial payers, I think they're very interested and are open to making it available, and will leave it up to the physician. I think the neurology community is going to be cautious coming in until they get through a few treatment cycles. Yeah which is why we said we expect kind of modest revenue this year. But based on that experience, then I think that's gonna set a really nice foundation going forward. Because they're gonna start conservatively with the first treatment cycle- Yeah ... and then dose up, and then dose up, depending on what their comfort level is. Have you seen any willingness to explore other potential indications? I know it's not something that you're promoting. Correct. But, you know, we know that physicians get, Yeah ... they all, regardless whether they're dermatologists or- Right - pain specialists - Yeah They'll experiment. And just thinking about upper limb spasticity and other potential target indications. Yeah, so a few things there. You know, we have phase II, robust phase II data in upper limb spasticity. Yeah. We have two IITs going in migraine right now. As I mentioned earlier, you know, commercial payers, if I look at sort of a, the commercial payer universe, I'd say about a third sort of just cover toxins generically. Wherever you use a toxin, they'll cover it. About a third are open to covering outside of the labeled indication based on clinical data, and then about a third are indication specific. So we have definitely heard of some of the customers, based on the experience that they're having with CD, use it in other areas. To your point, it's not something that we are focused on or can promote on or anything else there, and, but we will look to continue to expand indications. I think we'll use the CD learning journey to inform sort of what's next for us on that, but we definitely are aware of some clinicians using it in areas other than CD. Got it. Okay. Maybe we can talk a little bit about just the financing, dynamics- Right that the company has going forward. What are the, you know... You've talked about a potential opportunity to get to breakeven, with your existing and kind of the your access to cash and debt. Just interested to maybe go through a little bit of that. I think there's a potential tranche that could be accessed sometime in the near future. Can you just help us understand, you know, the opportunities from both an access to debt perspective- Right but also, you know, your path to breakeven? Sure. So I'll start with the breakeven. We feel very good about our ability to get to, you know, adjusted EBITDA breakeven in 2025- Mm-hmm ... based on our current cash position and expected revenue generation, and so we continue to march towards that. Yeah, we made some moves last year to streamline our expense structure because of the complexity of our business. We had a biosimilar program, we had OPUL- Yeah We had Viatris, we had Fosun. And so we sort of said, "Hey, we need to focus a little bit more on things that are right-sized for where we are in our journey." So we got rid of OPUL, we streamlined our drug product manufacturing, we made some restructuring moves in our commercial operations, and then we collapsed some of the associated G&A on that side of it. So we think we're in a much better position from an OpEx structure. A matter of fact, we're down on a year-over-year basis. But we've still made sure that we can, you know, fully fund the aesthetics and the therapeutics launches, so we wanna make sure that we had the dollars there. We came into this year with $250 million in cash, so we feel like we're in a good position. We've got $150 million in term debt that will be due in 2026, and then the converts sitting out there in 2027. So we think we've got time to demonstrate and prove. We believe that we've got a lot of optionality. We've not made any decisions on international yet, so there's some optionality there. Right. We're just getting going on therapeutics. There'll be some opportunities if we want to evaluate different things there. And so, you know, we're aware of sort of a range of options that we have, non-dilutive and other things. Got it ... that we could do to make sure that we're in a, in the right position going forward. From a non-dilutive perspective, you know, it would seem like there are, you know, a number of potential international— Right ... opportunities- Right - to capitalize on. What if there were markets that, you know, you would, you know, sort of say, "Okay, this would actually... You know, these are interesting markets- Right - We have familiarity with, where there's been good execution and uptake of new products, which ones, you know, maybe, might you point us to? Yeah. Well, we obviously did a partnership with Fosun, so we already- Yeah ... have an existing partnership for China. Interestingly, we have milestones associated with approval of their glabellar lines and their cervical dystonia program, both of which have been filed, and so there's an opportunity to receive some monies associated with those approvals. I think then you look kind of holistically at Europe as sort of a big market opportunity. Yeah. We've already filed in Australia. That's a very good market. It's smaller, but it's good from an end user pricing perspective. And then obviously, you can move into South America. Some of these markets have lower end user pricing, so part of what we're trying to rationalize as well is, where are we in that supply chain journey- Right ... in terms of where our cost of goods are, and what's the right time to open those markets up? I got it. Okay. And when you know, would, you know, sort of meaningful improvements in, in cost of goods, and access to that, you know, really be achieved? Well, I think it's gonna be a, you know, it's gonna be a steady, you know, progress there. Okay. So we started making product originally in Newark, where we make our drug substance. That was never designed to be a high throughput place. Now, we've expensed a lot of inventory as an R&D cost that we made before approval- Yeah ... so we've got some zero-cost inventory, but that's a very expensive place, and that's why we created a CMO relationship with Ajinomoto, which is now a step down in our cost. And now with, you know, PCI, formerly LSNE, that will come online in probably the 2026 timeframe, late 2025, that will then take it another step down. Got it. And as we just kind of remind investors, in terms of the trajectory- Right ... you know, we talked about a little bit of a, you know, a dip in the first quarter. Right. That's pretty standard with this market. Let me just remind folks how the aesthetic market kind of tends to play out on a- Sure ... quarter-to-quarter basis- Sure ... as we, as we wrap up. Sure. Normally, Q1, seasonally the slowest quarter, and we talked about that for two reasons. Mm-hmm. One is it's seasonally slow, and two, for us, particularly with DAXXIFY, we're focused, you know, on the existing accounts, which you said was part of that two quarters to roll this out. Q2 then tends to be a very strong quarter. Q3, seasonally slower than Q2, and then Q4, the strongest quarter of the year. Yeah. Sort of Q1 down, Q2 up strong, Q3 slightly down, and then Q4 strong. Got it. Okay, super. Yeah ...... Mark, well, I think we have to wrap up, but... Okay ... thanks so much. Great. Look forward to, actually, I guess, the full- Yeah ... report of your fourth quarter results. Absolutely. You know, coming up soon. Great. So- Thanks for the opportunity. Thanks so much. Appreciate it. Thanks.
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