Good day, ladies and gentlemen, and welcome to the Evolus conference call. As a reminder, today's conference is being recorded. I would like to introduce your host for today's conference, Mr. Ashwin Agarwal, Vice President, Finance, Investor Relations, and Treasury. Sir, please go ahead.
Thank you, operator, welcome to everyone participating in today's call. This call is also being broadcast live over the internet at www.evolus.com. The webcast and accompany slides can be accessed from the events and presentation page in the investor section of the Evolus website at www.evolus.com. A replay of the call will be available on the company's website for 30 days. With me on today's call are David Moatazedi, President and Chief Executive Officer, Rui Avelar, MD, Chief Medical Officer and Head of R&D, and Lauren Silvernail, Chief Financial Officer and EVP Corporate Development. In our remarks today, we will include statements that are considered forward-looking statements within the meaning of the U.S. security laws. In addition, 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 quarterly report on Form 10-K for the year ended December 31st, 2018, filed with the SEC on March 20th, 2019. Actual results may differ materially from those expressed in or implied by the forward-looking statements. The company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Now, let me hand the call over to David Moatazedi.
Good morning, thank you all for joining our call. As you know, we are weeks away from the highly anticipated U.S. launch of our premium product, Jeuveau. We believe the data discussed today will support our position at launch and our ability to compete and achieve the number two market share position within 24 months. Today, we are pleased to share with you the much-anticipated and now complete data set from our European and Canadian phase III trial, the largest head-to-head aesthetic pivotal trial versus BOTOX. We are pleased that the Aesthetic Surgery Journal has accepted and published this landmark study in their April issue. This publication shows we achieved the primary and secondary endpoints, for the first time, we will share the results of 30 head-to-head exploratory data points. Rui will now provide additional context around the data set. Rui?
Thank you, David. If we can move to slide three, please. Back in February, we gave you a high-level tour of the TRANSPARENCY clinical program. Today, we're pleased to announce that our phase III head-to-head Jeuveau versus BOTOX study has been published in the Aesthetic Surgery Journal. We'd like to take a few minutes this morning and walk you through some of the highlights of the publication. Slide four. This phase III study was multi-center, randomized, double-blinded. It's a controlled study, and it was conducted in Europe and Canada. Slide five. It was a single-dose trial, and it went out to 150 days. 540 subjects were randomized, five to five to one, either to Jeuveau, BOTOX, or placebo. Majority of the patients in the actives. Enrolled subjects were 18 years of age or older and had moderate or severe glabellar lines at maximum frown.
They also had to find that their glabellar lines had an important psychological impact on them in order to be eligible for the trial. Slide six. The primary endpoint in this study was a non-inferiority design versus BOTOX. In order to be a responder, a subject had to have a glabellar line rating of either at maximum frown of zero or no wrinkles, or one, mild, at day 30, as assessed by the investigator. Slide seven. There were also a number of other secondary endpoints included in this publication, and we'll just highlight a few here on the call. Slide eight. When looking at a comparative study, it's really important to also look at the baseline demographics across the arms. As we look at age and sex distribution here, we see that it's fairly equal across the two active arms.
On slide nine, given that the responder definition in this study was a zero or a one, baseline glabellar line severity scores become extremely important. Specifically, subjects with a baseline score of two or moderate only need a one-point improvement to become a responder. In contrast, subjects with a baseline score of three or severe need to have at least a two-point improvement to become a responder. In other words, the more severe patients enrolled in the study type, the harder it is to become a responder. As such, one wants to make sure that the distribution between moderate and severe subjects is relatively similar between the two active arms. This is also another reason why results cannot be compared across studies. You'll note that most of the patients in the study here were three or rated as a severe.
The majority required a two-point improvement in order to be a responder. Slide 10, primary endpoint. Looking at the primary endpoint responder rates on day 30 as assessed by the investigator, we see that 87.2% of Jeuveau subjects were responders, compared to 82.8% of BOTOX subjects. Slide 11. Primary endpoint was a non-inferiority analysis, and here you can see the results. The difference between the two treatments was in favor of Jeuveau at 4.4%, and you can see the lower limit of the two-sided confidence intervals were well above non-inferiority. Clearly, the study met the primary endpoint of non-inferiority. Slide 12. On slide 12, we show some of the secondary endpoints. At day two, the beginning of the study, and at day 150, at the end of the study, Jeuveau statistically superior to placebo, as measured by a one-point improvement on GLS scale by investigator assessment.
We also looked at subject satisfaction on day 30. Again, you could see that Jeuveau was superior to placebo at 91% versus 6% in the placebo arm. Slide 13. Looking at the exploratory endpoints, we can get a sense of how Jeuveau performs over time, from day two all the way to day 150. In this publication, you can see for the first time all three arms of the study side by side, Jeuveau, BOTOX, and placebo. This slide looks at subjects with at least a one-point GLS improvement, as assessed by both the investigator and the subjects, up to 150 days. The red bars are Jeuveau, the dark gray bars are BOTOX, and the light gray bars are placebo.
On slide 14, this gives you the Global Aesthetic Improvement Scale perspective over the entire study, where a responder had to be improved or much improved. You can see the head-to-head scores from the beginning to the end of the study. On slide 15, we have another important metric, the assessment of subject satisfaction. Here, a subject had to be either satisfied or very satisfied in order to be a responder. Again, all three arms are here for physicians to assess. Slide 16. Additionally, in this publication, the safety data has been broken out into greater detail. We have a couple tables here that were reproduced from the paper. On the top line, we have all adverse events. These include events that were both related to the drug and those that were not related to the drug.
On the third line, you can see the frequency of study drug-related adverse events. On both these lines, we see that the numbers were similar in both active arms. Of note, there were no serious adverse events that were related to either drug. On slide 17, we can see all adverse events, both related to the drug and not related to the drug, with a frequency of greater than 1%. Again, there's a substantial amount of detail here so the reader can compare across three arms, Jeuveau, BOTOX, and placebo. Slide 18. In closing, we're very pleased to have this paper published. This is a validation of the quality of the study.
We're also very happy to have all of the head-to-head data available now, which includes 30 new head-to-head data points, where clinicians can see the results any way they like, by glabellar line scale, Global Aesthetic Scale, or subject satisfaction, from the beginning of the study to the end at 150 days. With that, I'd like to turn it back over to David.
Thank you, Rui. Before turning to Q&A, I would like to thank our entire R&D team and all of our investigators for their work to complete this trial and to advance our submission for publication, as it marks another critical milestone ahead of our U.S. launch of Jeuveau in the coming weeks. Thank you all for your time, and we look forward to seeing many of you at our Investor and Analyst Day on May 8th. Operator?
Thank you. Ladies and gentlemen, if you have any questions or comments at this time, please press the star and then the one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Once again, if you have a question or a comment, please press star then one. One moment for questions. Our first question comes from Louise Chen with Cantor Fitzgerald. You may proceed.
Hi. Congratulations on the data, thanks for taking my questions. I had a few here. First question I had is, will you actually be launching with this 150-day data? If so, how will your reps convey this data to doctors? Secondly, are you going to be presenting this data at any upcoming medical conferences? If you will be, which will those be? What was the receptivity to the one-month data that you had previously presented? I have a couple more. Why don't I stop there for a second?
Great. Thank you for the questions, Louise, and good morning. I'll start with the first two questions, then I'll turn it over to Rui to address the third. As it relates to the data, this publication is now available online, our sales force will be fully trained on this data and will be able to speak to it with customers in the field upon launch. We look forward to disseminating this data widely as we commercialize Jeuveau. Separately, as it relates to medical conferences, as you know, the next major medical conference in this space is the plastic surgery meeting called ASAPS. We will have a large presence at that meeting, and Jeuveau will be presented from the podium.
Okay. What was the receptivity the first time you put out the one-month data? Just trying to compare now that you have longer data, how that might be viewed.
Sorry, Louise, just so I'm clear, when you say one-month data, the 30-day data?
Yes. I'm sorry. Yes, the 30-day data. Sorry.
Yeah. From a primary endpoint perspective, when people look at it, of course, it's non-inferiority. When you actually look at the data and actually in the journal, the journal actually came back with comments to say, "Could you elaborate on what this means?" When you look at the primary endpoint of non-inferiority and you put the confidence intervals, the first thing you see, it meets the definition of non-inferiority. The next thing, from a qualitative perspective, the fact that the confidence intervals cross zero states that there's no statistical difference between the two products. The commentators in the journal actually asked us to put that into the article. That was kind of an important thing. The other really interesting thing about the 30-day data is the other secondary endpoint. At the end of the day, the patient's always right. Your customer's always right.
It's very interesting to see the level of subject satisfaction and how that holds throughout the entire study. It's an interesting variable because it goes beyond just the aesthetics. Patients are asked for levels of satisfaction, satisfied, very satisfied, and this is a question that transcends just the glabella line aspects. It's something that not only are we getting positive feedback, but clinicians are actually coming to us and trying to understand why those scores are so high.
If I could just squeeze in two more questions here. What do you expect to present at your upcoming investor day, and will this investor day be ahead of the launch, in conjunction with the launch, timing-wise relative to launch? The last question I had here is if you could provide an update on the E.U. opportunity and the size of the Canadian opportunity and your go-to-market strategy for both. Thank you.
This is all yours.
The first question, I'll start with the U.S. and E.U. opportunity. As you know, we recently announced that we expect an opinion for the European Union in April, and then of course, the approval will typically follow that opinion within roughly 90 days. At this time, once we get to approval, we expect that we'll be able to provide more details around our commercialization plans, including what we've mentioned before, which is we'd look to bring in a partner for Europe, and of course, we'll provide more detail as we get there. As it relates to the U.S. commercialization plans, look, we're weeks away. We're very pleased with the progress we've made. We now have our commercial structure in place.
This week, we have our sales management team here in Newport Beach, and they're doing the last of the preparations in anticipation of our national meeting, which takes place the following week. We're actively preparing in our final stages. As you know, this dataset was critical to release prior to the commercialization of Jeuveau, and we have now done that. We've cleared all the milestones in preparation for the launch. Now, as far as the investor day, we'll provide a lot more color around the commercialization strategy. As you know, we've been strategically quiet around how we plan to introduce Jeuveau. Thus far, the way we think about it is, it's a book with many chapters, and one of those chapters is related to the commercial launch.
I would say that's the chapter that we've provided very little exposure publicly to how we plan to do that, and the upcoming investor day will be entirely focused on how we will create a new brand in the space that consumers will ask for and that we believe doctors will see a lot of value in as we commercialize.
Okay, thank you.
Our next question comes from Annabel Samimy with Stifel. You may proceed.
Hi, guys. Congratulations on the data. Good granularity there. I want to ask, you obviously have a number of secondaries here. Essentially you look numerically better on all of them. I guess I'm curious, if it wasn't designed for statistical significance, in your experience, how do physicians respond to data like this? It seems like they always went by feel, by what patients felt. How strong does this data need for them to say, "Okay, this is absolutely much better, high quality, superior." How much of it is perception versus needing to see data? I guess that's one of my questions. Which of the endpoints do you think is most meaningful for both physicians and patients, and what do you think will resonate with them? Finally, a third question. Sorry, there's a lot of them.
You had a couple of investigative endpoints in the anxiety and depression area, which is really interesting because Allergan has sort of always toyed with the idea of depression. What do you expect to do with these? How important is this to the overall picture for Jeuveau? Thank you.
Sure. Thank you. I'll try to handle all of them. It's interesting. You never know what's going to resonate the most. The primary endpoint, of course, is the most important thing in the study because everything is driven off it. If you fail the primary endpoint, nothing else matters at all. Clearly the primary endpoint's really robust. It's a non-inferiority design again. One of the reasons why we show the primary endpoint the way we do is because confidence intervals tell so much more of a story. If you look at the FDA guidance for reporting out non-inferiority, that's how they do it. When you see the visual, you get a much better sense of what actually happens. You could see the two responder rates, where BOTOX is, where Jeuveau is, and you could see clearly the difference between the two, that it meets non-inferiority.
Qualitatively, you also see the story that, again, as the journal quotes, there's no statistical difference between the two. The interesting thing is how it trends in favor of Jeuveau. The next question is, this is where do the exploratory endpoints actually support that observation or not, and that's kind of basically the comment you made. You're right, your observation's correct. There's 30 new endpoints there, and you can count them, and you could just see how many of them are actually in support of that primary endpoint, just to see the alignment between the primary endpoint and what the exploratory endpoints are. When you ask me things that I think are going to be most important, it's funny, I thought it would be the primary endpoint because, again, it is the most robust.
It's amazing how much people gravitate towards the subject satisfaction number, again, a really high number at the end of the day when it's a patient that you're dealing with, I think it's actually quite a nice offering to have a subject satisfaction value that is as high as it is. We can track it all the way to 150 days. Your last question, you're right, I didn't mention it here, but we did look at the anxiety and depression scores. In the spirit of, I think, a rising tide, all boats come up, we've taken the position that we think that it's an under-penetrated market, there's a lot of very good products on the market.
When we looked at the anxiety and depression scales, we took a baseline score using a validated scale, we compared and looked at the respective scores 90 days later. What we found was that both in the Jeuveau and the BOTOX arm, there was a statistical improvement in both the aesthetic and the depression scores. The placebo is a little funky because of the five to five randomization. In particular, if you look at depression, there was a statistical improvement both for Jeuveau and BOTOX, not for placebo. I think that's a really interesting element. I don't know how much we can market on that here in the U.S. because this is a U.S. study. It's certainly something that goes into the public domain, we also know that good phase III, well-controlled studies, the FDA has given us liberty to market.
We'll have to be thoughtful in terms of how we do it. Given that this is a quality study in the public domain, we're very interested to see how clinicians gravitate towards it.
Okay. If I could just ask one more follow-up again. From your experience with physicians, do physicians really pick through data like this, or do they typically go with what works for their practice, what patients are asking for? Is this something that's really going to drive some of their practice habits or change in their practice habits?
Again, that's another good question. We know that, I think, the barrier to entry is the quality of publication. You need a quality study, you need quality data. We have that obviously. At the end of the day, the patient experience, because this is private pay, is absolutely essential. With that, maybe I could turn it over to David for his comments on that.
Yeah. Look, I think the TRANSPARENCY data in its entirety is what gives doctors the confidence in the quality of Jeuveau. We've seen this consistently through different advisory board meetings and customer interactions, that when they see this full data set, it's comprehensive. 2,100 patients, five different studies, the largest phase III head-to-head study ever conducted against a market leader. That's what gives them the confidence to try Jeuveau. Of course, this is the anchor, is the science in our data. From there, it's the commercialization strategy, which we'll unveil at the upcoming Analyst Day.
Okay. Great. Congratulations again. Thanks for the data.
Thank you.
Our next question comes from Irina Koffler with Mizuho. You may proceed.
Hi. Thanks for taking my questions. In the BOTOX Cosmetic label, it looks as if only 39% of patients are moderate to severe, your study used much more severe patients. Does that make your data more impressive, or maybe you can comment on how to interpret that? The second question is, today Allergan released a new piece of market research that it sponsored. It's some kind of 360 survey. How do you think that they're going to use that piece competitively, and is there anything in there that you think may actually be helpful to Evolus in terms of crafting its own messages? Thanks.
Thanks, Irina. I'll take the first question. We're going to take the high road on that first question, obviously. Allergan put out a quality publication, it really is not fair to compare their publication to ours, I can't comment across the data. We should never do that, which is why we did the head-to-head. If we want to talk about head-to-head data, we have to restrict our conversation to the study that's published, that's head-to-head. I'll leave it there, I'll turn the second question over to David.
Yeah. This morning, as you can imagine, we've been preparing for this call, I haven't had a chance to review Allergan's statements. I'm sure as they have in the past, they'll put together quality data, we'll have a chance to look through that, happy to share my thoughts with you after I get a chance to do that.
Thanks.
Our next question comes from Donald Ellis with JMP Securities. You may proceed.
Good morning. I just have one question regarding the data in the paper you released this morning, and it's dovetailing off the last question. How would you expect Allergan or Merz or Galderma to counter-detail the paper that you presented this morning? Thanks.
I don't know. We'll have to see. Some of the things that are kind of interesting is we've already heard some comments about the fact that the primary endpoint was a per-protocol analysis and that patients are missing, and they wonder what the data would be if all the data was in there. That's kind of the most interesting comment. My quick comment to that is, why did we do a per-protocol analysis in a non-inferiority study? The answer is because you're supposed to. When you do a non-inferiority analysis, you always try and do the most onerous population, so that's why the per-protocol is there. People were wondering, well, what happens when all the patients are there, i.e., when you do an intent-to-treat analysis of the primary endpoint? The nice thing is in the paper also.
The intent-to-treat means everyone that was treated goes in there. When you look at the results that are also published, you see the exact same pattern as we saw with that. I don't know what the other counter details are going to be, but that's certainly the main one that we've heard thus far.
Great. Thank you.
Our next question comes from Greg Fraser with SunTrust. You may proceed.
Morning, guys. Thanks for taking the questions. It's Greg Fraser on for Greg Gilbert. On the patient mix between severe and moderate, is that mix similar to what you would expect to see in a real-world population?
Well, that's again, another great question. That's probably going to vary district- to- district, practice- to- practice. It depends on what scale you would use. It's a very good question. The reason why it's so important in this kind of study is when you have a study that only looks at a one-point improvement, then everything's good. If it's a two-point improvement, then everything's good. When you use a responder definition of a zero or a one, you could see how, if there's an imbalance, it becomes unfair. Specifically, if you actually look at it, we had a few more severe patients in our study than BOTOX. If anything, we kind of drew the short end of the stick on that one. Where it becomes more applicable is when people try to compare across studies.
For instance, if there's a study that has a lot of easy patients or the moderates, and you try to compare that to a study that had a lot of severes, that's kind of like comparing your running time with a 100 meter dash with somebody else's running time, but they ran 200 meters, right? That's why I was kind of pointing that out. When you have that kind of design, you want to make sure that it's fair between the two arms, that's why we're really pointing a light on that. Again, what happens in real life, it's probably going to be patient specific. There's probably certain areas where patients are young and they may not be as impacted, and some demographics change in different practices.
Got it. That's very helpful color. Can you also just comment on any changes in behavior that you've already seen from Allergan as Jeuveau has gotten closer to market? Also whether you've seen any changes from Galderma and Merz.
As you know, we have not launched yet, we don't have our sales force actively promoting in the field yet. We'll probably get a better sense for how the competitors choose to counter detail against us as we get into the market. We've been actively focused on preparing our commercialization strategy. We had set a number of key milestones, as you may recall. One was to build out our sales force of 140 sales representatives. We've accomplished that. The other was to have our entire TRANSPARENCY dataset published. That has now been accomplished in Dermatologic Surgery, as well as the Aesthetic Surgery Journal article with the head-to-head trial today. Of course, the launch in the coming weeks is going to be critical to driving that. We'll look forward to giving you more updates on the competitive landscape in future calls.
Got it. Thank you.
Thank you, ladies and gentlemen. That concludes our Q&A portion of today's conference. Thank you for attending today's call. You may all disconnect. Everyone have a great day.