Good morning, ladies and gentlemen, welcome to the Evolus Extra Strength Interim Data Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If you joined us via the telephone and require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, today's call is being recorded. I would now like to introduce you, our host for today's call, Mr. David Erickson, Vice President of Investor Relations. Please go ahead.
Thank you, operator. Welcome to everyone joining us on today's call. Our presenters today are David Moatazedi, President and Chief Executive Officer, and Rui Avelar, Chief Medical Officer and Head of Research and Development. Before we get started, let me run through a few housekeeping items. Our prepared remarks today will include forward-looking statements within the meaning of United States securities laws. Management may make additional forward-looking statements in response to your questions. Forward-looking statements are based on management's current assumptions and expectations of future events and trends, which may affect the company's business, strategy, operations, or financial performance. A detailed discussion of the risks and uncertainties that the company faces is contained in its annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K. Actual results may differ materially from those expressed in or implied by the forward-looking statements.
The company undertakes no obligation to update or to review any estimate, projection, or forward-looking statement. Today's call is being webcast with slides. If you have connected to this call by phone only and wish to view the slides during the call, please also connect to the webcast or download a copy of the slides that have been posted to our website just a few minutes ago. Both the webcast link and PDF copy of the slides are available on the Events and Presentations page of our investor relations website at evolus.com. During today's call and after management's prepared remarks, we'll open it up for questions. Participants may enter the question-and-answer queue either by telephone or by submitting a written question via the webcast. We'll take as many questions as we have time for until the end of our one-hour call.
Lastly, following the conclusion of today's presentation, a replay will be available on our website at Evolus.com. With that, I'll turn the call over to David.
Thank you, David. Today, we're very pleased to share with you the same data we presented on Saturday at the IMCAS meeting in Paris, one of the largest aesthetics meetings in the world. This information was also summarized in a press release we issued that same day. This presentation was the first look at interim data from our extra strength phase II study of Jeuveau, a study that is still ongoing and expected to conclude by June. This means that the data we presented can potentially improve as patients that are continuing in the study return to baseline. As we embarked on this phase II study, there was some uncertainty about whether Jeuveau would meet the benchmark of 24 weeks that was established recently and whether the adverse event profile would be acceptable.
At the onset, we were confident that this new formulation of Jeuveau, which is a combination of a higher dose and higher concentration, would meet that important threshold. What we did not anticipate was the duration lasting 26 weeks, or as we internally coined it, a prolonged six months. This is a successful outcome that gives Evolus the ability to offer treatment options for customers and their patients using the same original strength Jeuveau vial simply by changing how the product is reconstituted. Along with the 26-week duration, we saw a very favorable safety profile, which is consistent with the controls in the study and which we attribute to the precise nature of Jeuveau. With greater control of local and distant spread, it makes Jeuveau ideally suited for use in areas where injectors and patients may want to use an extra-strength dose.
With the natural-looking results customers can achieve with Jeuveau, having two dosage strengths uniquely positions us in the under-penetrated and rapidly growing aesthetic neurotoxin market. I will now turn the call over to Rui to go through the data in more detail. Rui?
Great. Thank you, David. Yes, this morning I'd like to share with you the results that we shared on Saturday and the interim look at this extra strength, longer duration study. Again, it is an interim look, and it is a phase II. Sorry, it's a little slide. For a little bit of background, what we wanted to do here is look at Jeuveau, which is currently approved for 20 units in the glabellar line, in the context of an extra strength version. What we mean by an extra strength version is we effectively did two things. One, we increased the dose, and 2nd, we looked at hyper-concentrating the amount injected.
Given that we hadn't had this experience, we wanted to look at the safety efficacy in the respect to duration when we actually use this extra strength formulation. For a little bit of background, when we look at duration studies, we look at a few different parameters. One thing we can look at is something called the Glabellar Line Scale. Typically, a Glabellar Line Scale is a four-point scale where there's none, mild, moderate, or severe. These scales are validated, and they can be used by the investigator, and they can be used by the subject. It's a fairly good way to look at these things and gives you an accurate portrayal in terms of how effective your product is. However, patients don't typically look in the mirror and decide they're a two or a three. Instead, they like to look at aesthetic outcomes.
Another important thing to look at to make sure that your scale actually is working are using scales such as the Global Aesthetic Improvement Scale. Here, we're asking a different question. We simply ask, is there an aesthetic improvement? It allows you to effectively see if there's a correlation between patients actually having an aesthetic improvement and how the scales are performing on a validated scale. Finally, ultimately, we always ask our patients for subject satisfaction. Interestingly enough, when we use toxins, they tend to score very well. Another thing that's a little different when we look at duration is the way we measure things. Typically, people see graphs that are efficacy graphs, where it starts at zero, and you see kind of a curve that goes up and then back down.
When we look at duration, we use typically what's called a Kaplan-Meier plot. What you see here are all the responders on the far upper left. Then every time you see a little downtick, that's called an event. In this plot, the event is a patient who has lost the correction. Then you could see it ticks down as patients lose their correction and make their way back to baseline or whatever it is you're measuring. What the program also does is it reads the median or that 50th percentile and looks at the intersection where the majority of patients, i.e., the 50% mark, have started to lose their correction. Then it drops another vertical line to intercept and see how long it took, and that's what the time axis is.
When we look at time, it can be measured in a variety of different ways. People like to compare, and they like to kind of try and use a little bit of math to understand what's what. We typically measure in days, so you'll see our studies go out to 360 days, for instance, for a year. The conversion for days is pretty simple. You take hours, divide by 24, that gives you days. If you wanna look at weeks, again, fairly simple, straightforward conversion. You take days, divide by seven, and that gives you weeks. A little trickier is the conversion to months. If you just take weeks and you divide by four, you artificially inflate the number. For example, if you look at the number of weeks in a year and divide by four, you would get 13 months.
The right correction or division factor is 4.3, four or five, the numbers there, and then you get the right number. A little bit about the trial design. It is a single treatment. It is multicenter, double-blind, randomized, and there's an active control. It was conducted at five sites, 150 patients in total. Randomization was even, 1: 1: 1. The duration of the trial was one year long or until the subject returned back to baseline. We looked at stable patients, kind of on-label, 18 years of age and over. Of course, we enrolled moderate to severe patients as typically is done. The test formulation we call extra strength, and the way we get that is we actually use the 100-unit vial that's available today, and we reconstitute it differently.
We put less volume in, a quarter of the volume actually, 0.625 mils, and then you get this concentration of 8 units per 0.05, and then there's 5 injections. That's how you come up with the extra strength formulation. Primary objective of the study. Ultimately, when the study is over, the primary objective is to look at the duration of effect or time back to baseline, we're using the investigator's assessment. Baseline demographics. Well, one thing we know is age is important because as people get older, efficacy drops a little bit. We see fairly balanced, 47-year-olds in the extra strength arm, 50 and 47. We see predominantly females. 94% of the enrolls are all females. That's important because males typically have a lower response rate, so we want to make sure that was balanced.
We also see mostly white females, which is fairly typical when we look at aesthetic studies done here in North America. Another important thing to look at is actually the baseline severity. When we look at patients, and we ask the physicians to grade them, what you see is most of the patients actually had severe glabellar lines at baseline, 71% vs 72 vs 66. Why is that important? Well, when you use none or mild as a responder definition, this has a tremendous amount of bearing. You wanna make sure that the severity, you understand the severity across groups when you use this because we enroll moderate to severe patients. By definition, once you cross that line of none or mild, that's when you become a responder.
If you're a moderate at baseline, all you need is one point to become a responder. However, if most of your patients are severe or your patient is severe, you actually need at least a two-point improvement, i.e., double, to become a responder. Again, you always wanna make sure that those are fair, or you understand where they are. Safety. That was the primary reason why we did this at the halfway interval. This study, as you know, is one year. Typically, most of the adverse events take place in the first part of the... after you've been injected.
We went to the IRBs, and we went to the ethics committees, and we basically put in an interim look, primarily to understand the safety profile of a hyper-concentrated increased-dose Jeuveau. What we learned in the top line is that there were 33 adverse events up in this patient profile. You could see all adverse events, 18%, 33, 49%. Those are all adverse events, so that means related and not related to the drug. The next line is the drug-related adverse events. You can see there's really no difference between them. There's just a couple of events, three, two, and three. Another way of looking at the data is what about subjects, number of subjects. We saw that 26 of the 150 had an adverse event.
All adverse events, you see 12%, 20%, and 19%. Again, these are all adverse events that include related and unrelated. When you look at just the drug-related adverse events, not much different between the groups. You see three, two, and three. A little further broken down, you can see the type of adverse events, mostly headaches. We had one case of eyelid ptosis in the 40 unit, and you see one patient fainted with a vasovagal event. What about the severity of the adverse events? Of the 33 adverse events, what we saw was 88% of them were mild, and the definition of mild is barely noticeable. 12% were moderate, and 0 were severe, and there were no serious adverse events. If we look across the groups, you can see that fairly even distribution, most of them mild.
What about duration of effect? We also had an opportunity to look at some of the duration of effect, and one way we can look at it is none and mild back to baseline. What that means is you look at the responders who had a none or mild, and you ask the question, how long does it take that patient to go back to baseline? The median was 183 days. If you can convert that's 26.1 weeks or six months. Another way to look at it is look at all patients. All patients come in, and they have different baseline severity when they arrive. After they were treated, you ask the question, how long did it take that patient to go all the way back to their baseline?
Here you can see that the median was 183 days. Again, if we convert that into weeks, that's 26.1 weeks, and months, that's six months. Another way of looking at it is actually looking at how long you hold a 1-point improvement. Now, the reason this is significant is by definition, when we look at a scale, a change in one point is clinically significant. When we ask the question that way, what we see was 183 days was the duration of at least a one-point clinical improvement, which is also 26.1 weeks or six months. Finally, probably the most important question for the patient is, what about my aesthetic outcome?
When we ask the investigator to look at the subject and look at when, how long an aesthetic outcome actually lasted and how that correlated with their scale, we see they were almost superimposable. 184 days, or converted into weeks, 26.3 weeks or 6.1 months. In summary, we see that safety, there was a very similar across all the groups. 80% of the Adverse Events were mild, 12% moderate, no serious Adverse Events. When we look at duration, we saw across multiple parameters at this point in time, six months duration or 26 weeks. Those included Glabellar Lines back to baseline, none or mild back to baseline, how long a one-point improvement actually last, and Global Aesthetic Improvement. Finally, of course, the study is ongoing, and this is an interim result.
We're looking for, probably by mid-year, the study should be ending, and then we look forward to reporting the results after that's all done. Thank you. With that, I'll turn it back to you, David.
Thank you, Rui. In summary, here are the important things to keep in mind. We expect to complete the study by June, and our next update will be the presentation of final data sometime during the second half of 2023. These are interim data, and since some patients are still being evaluated, we expect these results will be maintained and possibly improve as we finish out the study. While the opportunity for an extra-strength product is meaningful and can help further expand the toxin market, our data suggests customers will continue to use the original 20-unit dose a majority of the time. With our aesthetics-only business model, we are confident Evolus is uniquely positioned to capitalize on an extra-strength dose.
Evolus continues to execute on its long-term strategy and already this year has announced several key achievements and milestones, including a strong preliminary finish to 2022 with the projection for continued above-market growth in 2023, further international expansion, and a target for achieving profitability. With these strong interim extra strength results, we truly believe the wind is at our backs and that Evolus is well-positioned to achieve our $500 million revenue target in 2028. With that, we'll open it up for questions.
Thank you. We will now be conducting a question and answer session. If you would like to ask a question and have joined us by telephone, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. If you have joined us via the webcast, please refer to the Ask a Question box, type in your question and click Send. One moment please while we poll for your questions. Our first questions come from the line of Annabel Samimy with Stifel. Please proceed with your questions.
Hi, guys. Thanks for taking my question. Congratulations on the strong data. I guess the first question is one of clarification in terms of the metrics that were used. Was it surprising to you that the GLS score returned to baseline none or mild GLS responders and the greater than one point improvement of GLS response was exactly the same? Is that supposed to line up as precisely as it did? That's just a clarification question. I guess the subsequent questions are really about how with this phase II interim data, how can you really use this data right now? It really is just about a reconstitution, it seems. Is it something that you can talk about with physicians?
The fact that you presented it in a forum, can you then discuss it with, I don't know, medical sales liaisons? How can you use this data? Then finally, if you're using the same vial, does this really change the pricing to the physicians when they're looking at purchasing vials? Is it really just what they offer on the back end to the patient? I just wanted to understand those three things. Thanks.
Thank you, Annabel. Maybe I'll take the first two and then hand the third one over to David. On the first one, yes, we're a little surprised. Obviously, the GLS back to the baseline of six months was a very nice value, or 26 weeks. The greater one point improvement was a little bit surprising for us. Obviously, it's higher than we've seen in past brothers, and we know what we had. It was, you know, our value was 21 weeks when we looked at our 20 units across multiple studies. As to why, I think it may be just kind of a saturation of the curve where we're now. We're only halfway through the study, this may be just a reflection of...
We know that people are still within the study, so that we may just see separation as the study goes on. The short answer is, it's probably where we are in the study, and people are still in there. As to your second question, you're absolutely right. The 100-unit vial is what you use currently to create the extra strength formulation, and it is basically a reconstitution step and what you draw up in. Yes, docs can use it today, and in fact, we have clinicians who've reached out and said that they've started trying and playing with it, quote, unquote, "in their practice." After I presented it in IMCAS, that was another question that I got asked quite frequently from HCPs was, "Can I try this myself?" Of course, they're free to do what they, what they like.
In terms of, I believe you're kind of delving into another point, you know, ultimately this gets published at some point, how you create the extra strength formulation will be part of that publication. Effectively, there's a recipe out there, and clinicians will be free to do what they want, which is fairly common. Doctors play with reconstitutions and how they treat. Finally, we have a medical affairs group that can actually speak to off-label unsolicited requests, and they'd be able to respond. Ultimately, it'll hover on having a publication out there that explains everything. The last one I'll turn over to David.
Thanks for the question, Annabel. As Rui just pointed out, we have customers that were already using the extra strength dose, and that helped inform the phase II study from the onset, and that's why we had the confidence going into it that the product would perform. What we have learned, though, is that our pricing is competitive today as it stands to using the extra strength dose. I think from that standpoint, we feel good about where we are. As you know, we have pricing flexibility because we're a cash pay business in order to optimize the relationship between both the 20-unit and the 40-unit dose. That can complement with our consumer loyalty program, and it gives us the latitude to operate over time. We're pleased to see the results.
I could tell you that I was receiving notes from customers over the weekend, and I think this brings clarity to Jeuveau users around what the extra strength dose brings to them relative to the original, which we do continue to believe will be the predominant use of neurotoxins is the original strength.
Okay, great. Thank you.
Thank you. Our next questions come from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your questions.
Hi, good morning, everyone. This is Carvey on for Louise from Cantor. Thank you for taking our questions. First question, at the data cutoff, what % or how many extra strength patients have reached the 26-week mark and still being monitored for duration results? Our second question is, based on the data available, what's a theoretical dispersion of duration that we can expect at the final results? Thank you.
Sure. This is a interim data cut, and we have a snapshot. I can't give you the exact percentage of patients. Well, I guess I can. You've asked what percentage of patients have reached the, in the extra strength arm that have reached 26 weeks. Just as a reminder, the first patient went in basically in March. Last patient was the end of June, and we're now in January, so everyone has gone past the six-month mark. All patients are there. When you ask about the extra strength arm, they've all gone through six months and, you know, obviously there's patients still within. Within the second one, theoretical, you know, I can't map this out. All I can do is share with you.
We know from past experience, if you look at the 2004 and the 2006 study, we have patients who lasted seven months with one treatment. We even have some patients who lasted a full year with one treatment, that was just at 20 units. I can't map this out theoretically, but rather this is why we do these studies. At the end of the study then, you know, we'll actually have the duration answers for you.
Got it. Just one more question. You did mention that there was a single subject that experienced eyelid ptosis. Were there any notable characteristics that stood out to you that might explain the AE?
I don't have specific insights. you know, we have one subject out of 50, so that'd give you 2%. I don't have any specific information on that patient if there's a reason why they had a ptosis, if that was the question.
Got it. All right. Thank you so much and congrats on the data.
Great. Thank you.
Thank you. Our next question has come from the line of Navann Ty with BNP Paribas. Please proceed with your questions.
Hi. Good morning. Thanks for taking my question. It's Navann Ty from BNP Paribas Exane. Just a question on the Jeuveau precision profile. Do you think with that data, would it allow a more natural look than long-acting toxin Daxxify? Thank you.
Well, thank you for the question. Obviously, I can't talk about it relative to Daxxify. This study, interestingly enough, was first set up to be a head-to-head against Daxxify. 'Cause of delays, we had to put in another arm. Until you have a head-to-head, it's unfair to talk about it. What I can say is, one thing that we know from clinical practice is we tend to have a more, quote-unquote, "natural look," and that's the feedback we've been getting from clinicians 'cause it hits certain points that allows lot of fibers to kick in. And that's actually one of the things that we're studying in this at the end, is the patients who have gone through the extra strength, how is that kind of natural feel and look compared to the 20 units?
We'll be able to compare our 20 units to 40 units from kind of that natural look perspective in this study.
Oh, thank you. Can I also follow up on the efficacy data for the other two arms, the 20 units BOTOX and Jeuveau? I don't think I've seen anything from the other two arms that will be helpful.
As I mentioned at the beginning, the reason the study was unblinded was this study was primarily a safety look at the interim. The bulk of the data that we had and dug into was on the safety, and we only had limited, at this point in time, looks at the other arms. The arm that was of interest for efficacy for most and for us also was how does the 40-unit arm look? In terms of how the 20 units of Jeuveau and 20 units of BOTOX compare, I think there's an abundance of literature out there right now. The 20 units of Jeuveau is being studied now in five large registration trials, two phase III that showed the, you know, one point was about 21 weeks.
We also have a very large 540 patient head-to-head against BOTOX, if you wanna do that comparison. In that you could see what the duration looks like all the way out. There is actually an independent paper that was published by two doctors out of Chicago, Bhatia and Xu. They looked at the comparison of BOTOX to Jeuveau. Finally, there was another recent publication that just came out comparing BOTOX to Jeuveau in males, and there you can actually see both onset and duration. So in this study, as I mentioned, this study was originally designed to be head-to-head against the other 40 units of the toxin, but it got delayed.
Instead, we just put these arms in, but I don't think we should see any surprises between the botulinum at 20 and Jeuveau at 20.
That's very helpful. Thank you.
Thank you.
Thank you. Our next questions are from the line of Serge Belanger with Needham & Company. Please proceed with your questions.
Hi. Good morning. Thanks for taking my question. I guess, first question on the adverse event profile. Was there any surprise that there doesn't seem to be any differences in drug-related AEs across the different arms, even once you double the Jeuveau dose? Secondly, is there enough data here for you to start contemplating the next step? I think in the past you've talked about a potential registration path. Maybe just talk about what that would entail. Thanks.
Sure. Thank you. The adverse event profile, I'm pleased to see that effectively there was no difference between the 40 units extra strength and the 20 units of either one. Basically they're the same. We actually anticipated this. One of the things that we've heard fairly consistently on Jeuveau is it's a pretty precise field of effect. There was a paper that was published by Kammer that actually speaks about the relative doses. If we think of the main adverse event issue is it's usually related to spread of the toxin. So we took an extra step, of course, we made it hyper-concentrated. Again, that was the main reason why we did this cut at six months, halfway through the trial.
You know, it was nice to see that we didn't see an adverse event that may be related to a very tight field of effect there. To your next question, the intent is to finish the study. The responsible thing to do is to complete the study, have all the patients go through, see what the data looks like, and then we're probably gonna hold some advisory boards to understand what the benefit is of taking this all the way through to a label or not. We won't make any decisions until we have the final data set. Again, the study, the one-year mark is June of this year.
Serge, are you still there by any chance? Or you may be muted.
I am. No, thanks for answering the question.
Great. Thank you so much.
Thank you so much. Our next question comes from the line of Greg Fraser with Truist. Please proceed with your questions.
Great. Thanks for taking the question. I'm curious how you view the interim results on efficacy vs the data that had been generated for 40-unit injections of BOTOX, and also whether you believe that there's much off-label use of higher concentrations of BOTOX currently.
The registration, you're talking about the BOTOX as in onabotulinumtoxinA?
Yes.
You know, we've seen some data cuts from onabotulinumtoxinA, and I think their one-point improvement was about 24 weeks, if I recall. They've also shown that when you increase the dose, that they can increase effect. Again, it's a different study, they're different centers, and they're different patients and investigators. I think they've shown an increase in duration when they do it, and they've used different doses that showed a plateau effect. We basically think that there may be a plateau effect, we just did 40 units in ours.
I'll add one additional comment there. As you know, brands like BOTOX are linked to the therapeutic side, which does not give them the pricing flexibility, meaning it effectively double the cost on a product that's already priced at a premium in the market. You haven't generally seen that interest. Of course, I think you have to look at the adverse event profile as you move the dose up in different drugs. We've talked about the uniqueness of the precision profile of Jeuveau. It's something we've learned as we've commercially marketed the drug, that the precision profile is very different with this product. I think you're seeing input to the test as we play with the formulation on this 40-unit dose that the safety profile of Jeuveau is also very strong.
I think the combination of the pricing flexibility and then the safety profile due to the precision of the product is just a unique differentiation point here.
That's helpful. I'm curious if the, if data was collected so far as part of the interim analysis on... I know investigators were probing for potential trade-offs with the higher strength version. Was that part of the interim, or will that be in the final analysis?
That'll be in the final analysis. Those are, you know, questions we try to capture. They're qualitative questions. There's questionnaires to try and understand if there were any trade-offs as patients gave feedback. Again, this is a interim cut where we really focused on the safety, and we're able to take some limited efficacy. Those are all questions that once everyone's done, that data will take some while to dig through.
Great. Thank you.
Thank you. Our next question comes from the line of Uy Ear with Mizuho. Please proceed with your questions.
Hey, guys, congrats on the data, thanks for taking my question. I guess my first question is, you know, what would you need to see, either in the final data or something that's exterior, such as maybe the uptake of Daxxify for you to sort of pursue an indication for the extra strength? My second question is, I think David mentioned that, you know, you have customers that are already using the 40 units. Just wondering, like, maybe some color on the how large that customer base could be and what you see as the potential opportunity going forward, I guess. Thanks.
I'll take the first question. I mean, it's a really good question. First of all, we've already seen metrics that are pretty competitive. If we look at one point, if we look at time to baseline, everything else, we already have a very competitive data set if we wanna go into a longer duration. Again, this is just an interim analysis. Secondly, we're gonna look for feedback from clinicians to understand what they're looking for and what they don't. Ultimately, to take it to label means is there an advantage to taking something all the way through to the label? Or do we just do a phase II study and then use medical affairs to market?
If I look at the competitive labels that we would be competing against, that would potentially kind of push us towards going into that investment, we see incobotulinumtoxinA or XEOMIN with a three-month label. We see Dysport and BOTOX with a four-month label. We see the other 40 unit that does not have a duration claim. Our label currently is four months. The typical patient that got treated, 970 patients, was treated three times. It's a four-month claim. When we look at the other 40 units, there is no duration claim. There is a curve, and there's being instructed to look at the median. We don't see a duration claim.
Certainly, when we go through the exercise of taking the curve in the PI or the product insert and trying to calculate where that intersection is, just kind of like I showed you, we don't see a claim there. And I'd encourage you to kind of go through the exercise and do your math on this, and you can see what how many weeks or how many months that converts into. Again, this is why we're gonna have advisory boards to understand kind of what makes sense for our next move for us.
On the second question, that you asked around utilization in the market today, what I would say is it's very small. The concept of using an extra strength formulation or higher dose is not commonly done today. From research, we do know that doctors are interested in understanding that relationship. Clearly, with 9,000 customers, we've had questions asked around how would Jeuveau's extra strength perform in the market. I think this preliminary data provides some color around that. I can also share with you as we released this data on Saturday, it's been less than 48 hours, and I've received a number of calls and messages around this data.
For some, it was confirmation of what they saw in their own clinical practice as they've been using the extra strength dose, and for others, it was interesting for them to see that the precision profile of Jeuveau delivered results that lasted 26 weeks, and then that the safety profile was as strong as it was. It was interesting having conversations over the weekend and many are starting to think about what that means in terms of their practice.
All right. Thank you.
Thank you. Our next question has come from the line of Douglas Tsao with H.C. Wainwright. Please proceed with your questions.
Hi. Good afternoon. Thanks for taking the questions. Maybe, David, if you could start because, you know, you prefaced the call by saying that when you talk to most of your customers, they indicate that, you know, your expectation that the market will largely remain on the regular strength. At the same time, you're getting a lot of interest and emails since you presented the data. I'm just curious, is it that some doctors are going to potentially use this a lot or a small number, or, you know, most doctors ultimately are just gonna use it in a, in a small segment of their patient population? Just curious to sort of understand some of those dynamics.
Sure. Well, Doug, I can tell you the conversations that I'm having, the majority would are interested just to understand the relationship between dose and longevity. That's the starting point. It starts with curiosity. From there, they are interested in trying it in some patients to see what the effect is. I think the questions that the injectors have, of course, there's economic questions, there's questions around whether the additional duration applies throughout the phase, right? Can you use the extra strength outside of just the indicated areas today that you have with other drugs, or is it something that could be broadly used? I think there's a lot more questions, Doug, than there are answers.
I suspect the latter is probably the case, at least today, if you were to survey doctors that, they'll trial it in a small subset of their patients, and they're going to assess it. In the end, it's not likely to be used in the majority of patients. That's what the data supported. It'll be for some patients, that are seeking that extra duration. There's many reasons why it benefits the practice, to continue to see the patients coming in more frequently, but also the fact that it's unlikely they'll be able to continue to use high strength, drugs throughout areas of the face. Meaning if you're not able to apply it everywhere, then the patient's going to have the product wearing off in some areas much earlier than others.
If you have that dynamic, the question is, well, what's the advantage of doing it? I think those are some of the things that the market's just gonna have to learn its way through and understand that. More importantly, I think there was always a question around, is there something unique about one toxin that makes it last up to six months, or is it ultimately a function more of the dose profile? I think this data validates that it is a function of the dosing and that it's not something unique about any particular toxin.
I was just gonna add, Doug, especially just after this weekend, it was interesting. I had a lot of interest in from clinicians who were in the audience, et cetera. It kind of lines up with what we said previously. Everyone's interested in having a longer duration, but when you ask them about how often they would want to use it throughout their practice, it's certain areas they'd be okay using and certain areas that they would not. The other number that we see battered around is the typical patient comes in twice a year, therefore have a toxin that matches that. A lot of clinicians, that's not what they want. They don't want to reinforce that behavior.
Some patients have a different cadence of coming in and, you know, their forehead may be wearing out a little earlier. They need filler in something else. Having the ability to have either a longer duration, if that's what the patient and the HCP wants, or kind of the typical 4-month duration, if that's what the patient or physician wants, having the ability to offer both is something that we're kind of looking forward to.
Just, David and Rui, I think I'm just curious, what's your or do you have a sort of hypothesis in terms of why the extra strength would work in some regions of the face?
Would not necessarily work in others. I guess face broadly defined, because presumably it's being used in the neck as well.
Yeah. I mean, it's a good question. I don't know that I have an answer for you, but I don't know it's so much a matter of not working, but rather the trade off and the potential adverse event you may have. For instance, in the forehead, when you have something, if it goes wrong and you have a brow ptosis, then you've got a brow ptosis for a long time if you use an extra strength formulation or a higher dose. If we look at the label, and the forehead's a pretty good place to look at. If you look at the label dose for the forehead, most clinicians actually underdose for that very reason. They would trade off not having the adverse event for a shorter duration.
It's interesting, Jeuveau is pretty precise, and it tends not to migrate, and we tend to have a fairly favorable profile. We just don't know until we go into these different regions. In other words, it's not so much not working, but rather trying to understand what the potential adverse events are. If you have one, it would last a lot longer.
Okay.
Thank you. There are no further audio questions at this time. I would now like to hand it back to the Evolus team for any web-based questions.
We have a couple questions on the web. We'll take them. Rui, I think, be the first one maybe read the question and then...
Sure. one question says, do you have the time to loss of none or mild, which is the criteria for FDA's duration? To be clear, that is not the criteria for FDA duration. The FDA has a guidance document. For a primary endpoint, the way you look at it is a composite none to mild or two-point improvement. That's the composite. For duration, typically, you use a Kaplan-Meier. A none or mild certainly is not the duration claim. Again, if we look at the 40 units that's been approved, there is no duration claim based on none or mild.
I think we might have already answered that one here.
Yeah.
maybe it's good to repeat the.
We've answered it. It's 20 units Jeuveau vs Botox. We've spoken to that already.
Okay. Those are all the questions that we have time for, so let me turn it back over to David for any closing remarks here.
Great. Well, thank you for joining the call. Obviously, we're very pleased with the results from this data. They're interim results, and we look forward to sharing the final data set and providing further clarity on how patients perform through the entire trial and then what that would mean for next steps. Thank you for taking time to learn about this data, and look forward to chatting with you on our next earnings call.
Great. Thanks very much.
Thank you. Thank you. That does conclude today's teleconference. You may disconnect your lines at this time. We appreciate your participation and enjoy the rest of your day.